history of the mcdonald-merrll..l-ketcham memorial lecture and award the story of this award and lectureship begins with a visionary alumna of indiana university: dorothy m. ketcham. miss ketcham received her bachelor of arts in economics in 1914 and her master of arts in sociology the following year. she joined the faculty of the university of michigan in 1921. in 1922, she became director of social services at the university of michigan hospital. in this capacity, she saw the important role that medicine and law played in the lives of those whom she served. in 1928, she established a multifaceted workshop and recreational facility for children confined to the hospital. while at the university she also wrote several books, two of which are devoted to hospital law. miss ketcham's affinity for the law grew out of her family's close relationship with the legal system. her grandfather, david mcdonald, was a practicing attorney in indianapolis, as well as a circuit judge. he was appointed to the united states district court in 1864, where he served until his death. dorothy's father, william a. ketcham, was a well-known indianapolis attorney. prior to being admitted to the bar in 1869, he studied law with his father, john l. ketcham, and judge david mcdonald. william ketcham was elected to the office of state attorney general in 1894 and served two terms. miss ketcham's interest in the health law extended beyond her scholarship. in a trust she established for herself and four of her sisters (miss flora mcdonald ketcham, dr. jane m. ketcham, and misses lilla and lucia ketcham), she made a remainder gift to the indiana university foundation to be used to assist the university in developing programs that would foster a greater understanding and better relations between the professions of law and medicine. miss ketcham was especially interested in furthering the careers of young medical and law students and instilling in them an appreciation for both professions. miss ketcham's generous gift, named for her grandparents (judge david mcdonald, john l. ketcham, and jane merrill ketcham), funds this prestigious lectureship and award for an individual who has demonstrated excellence in the fields of common interest to the two professions. it is fitting that the university honor miss ketcham's wishes by bringing to our campus distinguished scholars and leaders who bridge the gap between law and medicine. by inviting them to share their expertise with students, faculty and leaders of the legal and medical professions, we continue to support the ideals that dorothy m. ketcham espoused in her life and work. in recent years, the lecture and award have been made in collaboration with the medical humanities program, a new interdisciplinary project based in the school of liberal arts. this addition further integrates law and medicine into the academic community and encourages each discipline to think of itself in relation to others. xxi mcdonald-merrjll-ketcham memorial lecture and award recipients in conjunction with the indiana university school of medicine, the law school sponsors the annual mcdonald~merrill~ ketcham memorial lectureship and award for excellence in law and medicine. supported by a bequest to the two schools, this lectureship and award brings leading scholars and policy makers in the fields of law and medicine to the indianapolis campus for the benefit of students, faculty, the bar, and the medical community. the inaugural program was held in november 1994. award recipients and their articles are listed below. articles based on the lectures presented were published in the indiana law review until 2002, at which time the lectures started being published in the indiana health law review. 1994 tom l. beauchamp, professor of philosophy and senior research scholar at the kennedy institute at georgetown university. the justification of physician-assisted deaths, 29lnd. l. rev. 1173 (1996). 1996frances h. miller, professor of law at boston university school of law and professor of public health at boston university school of medicine. health care information technology and informed consent: computers and the doctor-patient relationship, 31lnd. l. rev. 1019 (1998). 1997 troyen a. brennan, professor of law and public health at harvard school of public health and professor of medicine at harvard school of medicine. beyond dead reckoning: measures of medical injury burden, malpractice litigation, and alternative compensation models from utah and colorado, 331nd. l. rev.1643 (2000). 1998 barry s. levy, past president of the american public health association and adjunct professor of community health at tufts university school of medicine. twenty-first century challenges for law and public health, 32lnd. l. rev. 1149 (1999). 1999 bernard lo, professor of medicine and director of the program in medical ethics at the university of california, san francisco. confidentiality of prescription drug information in the era of computers and managed care, 33 ind. l. rev. 937 (2000). 2000 clark c. havighurst, william neal reynolds professor at the duke university school of law. the backlash against managed health care: hard politics make bad policy, 341nd. l. rev. 395 (2001). 2001 -robert j. levine, professor of medicine and lecturer in pharmacology at yale university school of medicine. international codes of research ethics: current controversies and the future, 35 ind. l. rev. 557 (2002). xxiii 2002ruth r. faden, philip franklin wagley professor of biomedical ethics and executive director of the phoebe r. berman bioethics institute at johns hopkins university. legal and ethical considerations in government com­ pensation plans: a case study of smallpox immunization, lind. health l. rev. 1 (2004). 2003h. tristram engelhardt, jr., professor of philosophy at rice university, professor emeritus in the department of medicine at rice university, and professor emeritus in the department of community medicine at baylor college of medicine. giving, selling, and having taken: conflicting views of organ transfer, lind. health l. rev. 29 (2004). xxiv history of the mcdonald-merrill-ketcham memorial lecture and award the story of this award and lectureship begins with a visionary alumna of indiana university: dorothy m. ketcham. miss ketcham received her bachelor of arts in economics in 1914 and her master of arts in sociology the following year. she joined the faculty of the university of michigan in 1921. in 1922, she became director of social services at the university of michigan hospital. in this capacity, she saw the important role that medicine and law played in the lives of those whom she served. in 1928, she established a multifaceted workshop and recreational facility for children confined to the hospital. while at the university she also wrote several books, two of which are devoted to hospital law. miss ketcham's affinity for the law grew out of her family's close relationship with the legal system. her grandfather, david mcdonald, was a practicing attorney in indianapolis, as well as a circuit judge. he was appointed to the united states district court in 1864 where he served until his death. dorothy's father, william a. ketcham, was a well-known indianapolis attorney. prior to being admitted to the bar in 1869, he studied law with his father, john l. ketcham and judge david mcdonald. william ketcham was elected to the office of state attorney general in 1894 and served two terms. miss ketcham's interest in the health law extended beyond her scholarship. in a trust she established for herself and four of her sisters (miss flora mcdonald ketcham, dr. jane m. ketcham, and misses lilla and lucia ketcham), she made a remainder gift to the indiana university foundation to be used to assist the university in developing programs that would foster a greater understanding and better relations between the professions of law and medicine. miss ketcham was especially interested in furthering the careers of young medical and law students and instilling in them an appreciation for both professions. miss ketcham's generous gift, named for her grandparents (judge david mcdonald, john l. ketcham and jane merrill ketcham), funds this prestigious lectureship and award for an individual who has demonstrated excellence in the fields of common interest to the two professions. it is fitting that the university honor miss ketcham's wishes by bringing to our campus distinguished scholars and leaders who bridge the gap between law and medicine. by inviting them to share their expertise with students, faculty and leaders of the legal and medical professions, we continue to support the ideals that dorothy m. ketcham espoused in her life and work. in recent years, the lecture and award have been made in collaboration with the medical humanities program, a new interdisciplinary project based in the school of liberal arts. this addition further integrates law and medicine into the academic community and encourages each discipline to think of itself in relation to others. mcdonald-merrill-ketcham memorial lecture and award in conjunction with the indiana university school of medicine, the law school sponsors the annual mcdonald-merrill-ketcham memorial lectureship and award for excellence in law and medicine. supported by a bequest to the two schools, this lectureship and award brings leading scholars and policy makers in the fields oflaw and medicine to the indianapolis campus for the benefit of students, faculty, the bar and the medical community. the inaugural program was held in november 1994. award recipients and their articles are listed below. articles based on the lectures presented were published in the indiana law review until 2002, at which time the lectures started being published in the indiana health law review. • 1994tom l. beauchamp, professor of philosophy and senior research scholar at the kennedy institute at georgetown university. the justification of physician-assisted deaths, 29 ind. l.rev. 1173 (1996). • 1996 -frances h. miller, professor of law at boston university school of law and professor of public health at boston university school of medicine. health care information technology and informed consent: computers and the doctor-patient relationship, 31 ind. l. rev. 1019 (1998). • 1997 troyen a. brennan, professor of law and public health at harvard school of public health and professor of medicine at harvard school of medicine. beyond dead reckoning: measures of medical injury burden, malpractice litigation, and alernative compensation models from utah and colorado, 33 ind. l. rev. 1643 (2000). • 1998 barry s. levy, immediate past president of the american public health association and adjunct professor of community health at tufts university school of medicine. twenty-first century challenges for law and public health, 32 ind. l. rev. 1149 (1999). • 1999 bernard lo, professor of medicine and director of the program in medical ethics at the university of california, san francisco. confidentiality of prescription drug information in the era of computers and managed care, 33ind. l. rev. 937 (2000). • 2000 clark c. havighurst, william neal reynolds professor at the duke university school of law. the backlash against managed health care: hard politics make bad policy, 34 ind. l. rev. 395 (2001). • 2001 robert j. levine, professor of medicine and lecturer in pharmacology at yale university school of medicine. international codes of research ethics: current controversies and the future, 35 ind. l. rev. 557 (2002). • 2002 ~ ruth r. faden, philip franklin wagley professor of biomedical ethics and executive director of the phoebe r. berman bioethics institute at johns hopkins university. liberty, public health, and national security: the challenge of smallpox, lind. health l. rev. 1 (2004). • 2003h. tristram engelhardt, jr., professor of philosophy at rice university, professor emeritus in the department of medicine at rice university, and professor emeritus in the department of community medicine at baylor college of medicine. giving, selling, and having taken: conflicting v'zews of organ transfer, 1 ind. health l. rev. 29 (2004). • 2004 randall r. bovbjerg, research associate, health policy center; the urban institute, washington, dc. beyond tort reform: fixing real problems, 3 ind. health l. rev. 1 (2006). • 2005william m. sage,·professor of law at columbia university. pay for peiformance: will it work in theory?, 3 ind. health l. rev. 303 (2006). • 2006 -james f. blumstein, vanderbilt university law school, university professor of constitutional law & policy, director of the health policy center, vanderbilt institute for public policy studies. of doctors and hospitals: setting the analytical framework for managing and regulating the relationship, 4 ind. health l. rev. 209 (2007). microsoft word 1-masthead vol. viii.doc catherine sharkey catherine sharkey is professor of law at new york university school of law. she is one of the nation’s leading authorities on federal preemption in the realm of products liability. professor sharkey has published more than twenty-five law review articles, essays, reviews, and book chapters in the fields of preemption, punitive damages, administrative law, mass torts, class actions, and empirical legal studies. she is a 2011 guggenheim fellow. professor sharkey will join professor richard epstein as co-author of one of the leading torts casebooks and is co-editor with professor saul levmore of the second edition of foundations of tort law. she also served as a consultant to the administrative conference of the united states. professor sharkey earned a bachelor’s degree in economics, summa cum laude, from yale university. a rhodes scholar, she received a master of science in economics for development, with distinction, from oxford university (magdalen college), and her j.d. from yale law school, where she was executive editor of the yale law journal. she clerked for judge guido calabresi of the u.s. court of appeals for the second circuit and justice david souter of the u.s. supreme court. vaccines and drugs: a brave new tort world catherine m. sharkey* the proliferation of vaccine and pharmaceutical drug-related injuries challenges our conception of how the tort system can best meet its compensatory and regulatory aims in the twenty-first century. in 1986, congress created the national childhood vaccine injury act of 1986, establishing a no-fault compensation scheme for vaccine-related injuries.1 in 2011, the u.s. supreme court ruled in bruesewitz v. wyeth that design defect claims against vaccine manufacturers were preempted.2 this follows closely on the heels of the court’s decision in wyeth v. levine, finding that failure to warn claims against a drug manufacturer were not preempted.3 the symposium contributors—who include two prominent tort and product liability scholars (mary davis and robert rabin), a policy expert (james copland), and a seasoned litigator (malcolm wheeler)—explore whether it makes sense to have separate legal regimes for vaccines and other pharmaceuticals. they also address issues at the core of tort law in the modern administrative state: the need for no-fault victim compensation and the respective roles of litigation and governmental regulation. robert rabin’s remarks, the vaccine no-fault act: an overview, set the scene by outlining the structure of the vaccine injury compensation program.4 established in 1988, the vaccine no-fault fund provides an alternative to tort litigation related to childhood vaccine exposure. professor rabin details the stress put on the program by the recent omnibus autism proceeding, which brings to light the proclivity of the administrative scheme to reject awards based on scientific findings.5 but his overall assessment of the vaccine program is tantamount to a positive endorsement for the “expertise model” it embodies, with its reliance on low visibility decision-making, by expert special masters, insulated from various political pressures. james copland’s essay, administrative compensation for pharmaceuticaland vaccine-related injuries, builds on his previous work examining whether and how the vaccine injury compensation program can serve as a template for a federal administrative regime that marries broader compensa * professor of law, new york university school of law. chair, aals section on torts and compensation systems, 2010-11. 1. national childhood vaccine injury act of 1986, pub. l. no. 99-660, 100 stat. 3756 (codified as amended at 42 u.s.c. § 300aa-1 to -34 (2000)). 2. bruesewitz v. wyeth, llc, 131 s. ct. 1068 (2011). 3. wyeth v. levine, 555 u.s. 555 (2009). 4. robert l. rabin, vaccine no-fault act: an overview, infra p. 267. 5. id. at 272-73. 262 indiana health law review [vol. 8:2 tion with field preemption of tort law claims.6 mr. copland is a tort skeptic; moreover, he is critical of the stringent ex ante food and drug administration (“fda”) regulatory regime. he argues that the fda is more likely to commit “type ii” (denying entry to drugs that would prove to have enormous benefits) versus “type i” (allowing drugs onto the market that cause harms) error.7 indeed, according to mr. copland, the federal regulatory system, as implemented by the fda, costs far more lives by delaying and denying new drug entry, and increasing the costs of drug development than it saves by preventing drugs with unknown, harmful side effects from entering the market.8 moreover, mr. copland argues that the peculiar economic characteristics of the vaccine market—most notably, its supply-side sensitivity to tort litigation—make vaccines a prime candidate for an administrative compensation scheme in lieu of tort.9 with her essay, the case against preemption: vaccines & uncertainty, mary davis champions the significance of a continuing role for tort litigation alongside federal regulation of products generally, and vaccines more specifically.10 professor davis outlines some broad trends in u.s. supreme court preemption jurisprudence, such as the growing influence of federal agencies and the waning influence of the presumption against preemption.11 she laments the (perhaps temporary) passing of the presumption, which, to her mind, should operate to preserve longstanding traditional tort laws of responsibility. she adeptly showcases bruesewitz as involving “hyper-textual analysis which does not refer to the presumption against preemption, or to other elements of preemption doctrine for that matter.”12 professor davis closes with a cautionary note that the procedural drawbacks of the administrative compensation program relative to tort litigation must be scrutinized “to defend its effectiveness in carrying out its mandate to 6. james r. copland, administrative compensation for pharmaceuticaland vaccine-related injuries, infra p. 275. see james r. copland & paul howard, manhattan institute for policy research, in the wake of wyeth v. levine: making the case for fda preemption and administrative compensation (mar. 2009), available at http://www.manhattan-institute.org/pdf/fda01.pdf. 7. copland, supra note 6, at 279-81. 8. id. at 281 (citing tomas j. philipson et al., how safe is too safe?, 2 milken rev. 38, 44 (2006) (presenting evidence from empirical study comparing drug applications before and after adoption of accelerated review procedure under prescription drug user fee act (“pdufa”), finding that the cost of avoidable deaths for drugs approved under the accelerated process and later withdrawn was 56,000 life-years, compared with 180,000-300,000 life-years saved by drugs approved under the accelerated process)). 9. copland, supra note 6, at 285-287. 10. mary j. davis, the case against preemption: vaccines & uncertainty, infra p. 291. 11. id. at 296-303. for an in-depth treatment of the role of federal agencies in the court’s preemption jurisprudence, see catherine m. sharkey, products liability preemption: an institutional approach, 76 geo. wash. l. rev. 449, 471-77 (2008). 12. davis, supra note 10, at 307. 2011] vaccines and drugs: a brave new tort world 263 compensate and increase vaccine safety.”13 in his remarks, the case for preemption: why the u.s. supreme court and the administration are wrong to curtail implied conflict preemption, malcolm wheeler seeks not only to defend preemption on normative grounds, but also to illustrate how the u.s. supreme court’s hand in shaping preemption law is guided by the parties’ legal strategy.14 mr. wheeler compares and contrasts the litigation strategies leading up to the supreme court cases in geier v. american honda motor co.15 (which he litigated and argued) and wyeth v. levine16 (which edged out a case mr. wheeler was poised to take to the court).17 mr. wheeler tells the tale from the battlefield, where the strategic decisions regarding where to litigate cases18 and how to select an appropriate case for supreme court review are critical to the development of doctrine in evolving areas of the law. his story invites us to consider the contingency of the supreme court’s preemption jurisprudence: might the court have ruled differently in levine had mr. wheeler’s case involving ssri anti-depressants reached the court first? in particular, would the court have been receptive to the argument that, in the ssri context, the manufacturer should not be held responsible for failing to add warnings that had been considered and rejected by the fda (not to mention determined to have done more harm than good by the medicalscientific community)? taken as a whole, the symposium issue’s focus on the no-fault vaccine fund and preemption disputes in the pharmaceutical and vaccine contexts invites renewed reflection on the perennial health and safety debate that pits the decentralized tort system against a central administrative system. the participants represent a diversity of viewpoints. professor rabin takes an evenhanded approach, painting a picture of a compensatory and regulatory framework for vaccines that combines a no-fault administrative fund with some resort to tort law. professor davis urges more emphatically that tort litigation is needed for vaccine injuries as a “longstanding complement to more formal regulatory action for responding to uncertainty in risk information.”19 mr. copland argues, quite to the contrary, that, far 13. id. 315 (citing brief of marguerite willner in support of petitioners at 3, bruesewitz v. wyeth, 131 s. ct. 1068 (2011) (discussing procedural limitations in vaccine court, which does not authorize discovery as of right)). 14. malcolm e. wheeler, the case for preemption: why the u.s. supreme court and the administration are wrong to curtail implied conflict preemption, infra p. 317. 15. geier v. am. honda motor co., 529 u.s. 861 (2000). 16. wyeth v. levine, 555 u.s. 555 (2009). 17. wheeler, supra note 14, at 326-28. 18. compare, in this regard, the anecdote included in mr. copland’s essay regarding the propensity for plaintiffs’ attorneys to engage in “forum shopping” to find favorable jurisdictions in terms of known partisan judges and jury pools. copland, supra note 6, at 282-83. as mr. wheeler reminds, defense attorneys are well advised to consider forum when deciding the attractiveness of raising novel defenses. 19. davis, supra note 10, at 316. 264 indiana health law review [vol. 8:2 from serving as a useful complement to the fda’s regulatory scheme, the extra layer of review provided by the tort system generates a net social welfare loss, by further delaying introduction of beneficial drugs to the market and pricing consumers (and manufacturers) out of the market.20 mr. wheeler bolsters his anti-tort argument with an example where, he argues, tort liability (i.e., a finding of no preemption of tort claims where the fda had approved an antidepressant drug) led to adverse safety consequences, namely, increases in suicides due to decreases in use of antidepressants.21 finally, the diversity of backgrounds of the participants, from tort and product liability scholars to a policy expert and seasoned litigator, offers rich and varied perspectives on the evolution and future direction of the u.s. supreme court’s preemption jurisprudence. professor davis sees reason for pessimism on the express preemption front, where, as in bruesewitz, the court appears to be taking a statute-by-statute approach to preemption, guided by hyper-textual analysis, uninformed by background principles of tort and compensation. but professor davis is relatively optimistic about the trajectory for implied preemption, arguing that “the court seems to have settled into a more balanced approach” that values state common-law tort actions.22 mr. copland, by contrast, applauds the bruesewitz outcome and would, ideally, extend its concept of the “quid pro quo” of preempting tort claims in exchange for the provision of no-fault compensation beyond vaccines to include other pharmaceuticals.23 mr. wheeler disagrees sharply with professor davis about the merits of the court’s recent constriction of the implied conflict preemption defense, seeing it more cynically as the fruit of a long-wagered campaign, led by justice john paul stevens, to undo the outcome of geier, the court’s seminal implied conflict preemption decision.24 this symposium issue does not aspire to reach consensus among the participants, nor deem any contributor the ultimate victor. instead, it aims to provoke and to challenge pre-existing conceptions of how the tort and 20. copland, supra note 6, at 280 (citing tomas j. philipson & eric sun, is the food and drug administration safe and effective?, 22 j. econ. perspectives 85 (2008) (presenting evidence that litigation floods in the 1980s for the polio and dpt vaccines raised prices sevenfold and fortyfold, respectively)). 21. wheeler, supra note 14, at 328 (citing r.d. gibbons et al., early evidence on the effects of regulators’ suicidality warnings on ssri prescriptions and suicide in children and adolescents, 164 am. j. psychiatry 1356 (2007) (finding an inverse relationship between the twenty-two percent decrease in ssri prescriptions in the united states and the netherlands following fda’s directive for manufacturers to add suicidality warnings and a fourteen percent and forty-nine percent increase in youth suicide rates in the united states and the netherlands, respectively)). 22. davis, supra note 10, at 306 (noting with approval the court’s decision in wyeth v. levine, where the court wielded the presumption against preemption to uphold state tort law claims). 23. copland, supra note 6, at 289-90. see also copland & howard, supra note 6. 24. wheeler, supra note 14, at 330. 2011] vaccines and drugs: a brave new tort world 265 administrative systems should interact in the “brave new tort world” of vaccines and drugs. indiana health law review volumes 2008 issue 2 articles a proposal for comprehensive biobank research laws to promote transnational medicine in indiana jennifer girod katherine drabiak strained application of the viability standard to in vitro frozen embryos-deconstructing jeter v. mayo clinic arizona notes finally moving beyond the fiction: an overview of the recent brock j. heathcotte state rally for health care reform mark e. douglas attorneys, tell your clients to say they're sorry: apologies in the health care industry robin e. ebert your money or your lifestylet: employers' efforts to contain healthcare costs lifestyle discrimination against dependents of employees? brendan w miller mandating the gardasil vaccine: a constitutional analysis kyra r. wagoner symposium healthcare reform in america: getting beyond ideology to true reform march 19, 2008 mcdonald-merrill-ketcham memorial award for excellence in law and medicine health care reform in america: beyond ideology professor george j. annas transcript of the 2008 live symposium panel discussion james buechler, md. aaron carroll, md., matthew r. gutwein david orentlicher, md .. eric schmitz, kevin speer tit ~~ i_n_d_i_a_n_a_u __ n_iv_e_r_s_i_t_y 'i' _ school of law indianapolis iupui indiana health law review volumes executive managing editor mark e. douglas executive production editor lour j. britton clayton r. portell executive business editor jacob v. bradley note development editors matthew v. daley heather a. barnes b illi j. lycett john p. taylor kyra r. wagoner joseph e. bruno meghan a. cox elizabeth g. currid ravinder s. deol brenda k. devries adam d. dolce brian n. dunkel e. paige boggs shelley r. hallberg james blake hike bruce d. jones editor-in-chief robert r. elder articles editors keith a. butler matthew s. dionne robin e. ebert michael j. kyle blake c. reed members faculty advisors executive notes editor amyc. waltz executive articles editor emmal.haw jonathan d. stowers 2008 associate editors robert w. cochrane brendan w. miller erin m. saylor jessica d. williams kevin d. koons amanda g. koziura jackie s. landess allison l. matters matthew h. mccoy jennifer miller triplett heidi a. reed ann speidel sarah j. steinhart jennifer l. strange andrew j. vanlandingham lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2007-08 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university school 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indiana university school of law indianapolis iupui indiana university school of law-indianapolis 2007-2008 administrative officers and faculty administrative officers michaela. mcrobbie, president of the university. ph.d .• australian national university. charles r. bantz, chancellor, indiana university-purdue university-indianapolis. b.a., m.a., university of minnesota; ph.d., the ohio state university. gary r. roberts, dean and gerald l. bepko professor oflaw. b.a., bradley university; j.d., stanford university. paul n. cox, vice dean and centennial professor of law. b.s., utah state university; j.d., university of utah; ll.m., university of virginia. angela m. espada, associate dean for student services. b.a., indiana central university; m.a., indiana university; j.d., indiana university school of law-bloomington. jonna kane macdougall, assistant dean for institutional advancement. b.s., m.a., in diana university; j.d., indiana university school of law-indianapolis. claire grove, assistant dean for graduate studies. b.a., indiana university; j.d., indiana university school of law-indianapolis. teresa (terri) j. cuellar, director of technology services. b.s., st. bonaventure university, new york. elizabeth allington, director of external affairs. b.a., indiana university; m.a., m. phil., new york university. joyce m. hertko, director of major gifts. b.a., knox college; m.s., western illinois university; ph.d., indiana university. patricia kimberly kinney, director of admissions. b.s., purdue university; j.d., indiana university school of law-indianapolis. amanda kamman, director of development. b.a., indiana university. virginia marschand, director of administrative and fiscal affairs. b.a., m.p .a., indiana university; j.d., indiana university school of law-indianapolis. heather mccabe, director, public health law program, williams. and christine s. hall center for law and health. b.a., m.s.w., indiana university; j.d., indiana uni­ versity school of law--indianapolis. chastity thompson, director of professional development. a.s., b.a., alabama state university; m.b.a., auburn university; j.d., indiana university school of law­ indianapolis. law anda w. ward, director of pro bono program and public interest. b.a., murray state university; m.a., illinois state university; m.s., old dominion university; j.d., indiana university school of law-indianapolis. faculty cynthia m. adams, clinical associate professor of law. b.a., kentucky wesleyan college; j.d., indiana university school of law-indianapolis. judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. cyntilla baker, clinical associate professor of law and director, program on law and state government. b.a., j.d., valparaiso university. gerald l. bepko, indiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. karen e. bravo, assistant professor law. b.a., the university ofthe west indies; j.d., columbia university school oflaw; ll.m., new york university school of law. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. chestek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law. daniel h. cole, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school jeffrey 0. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school paul n. cox, vice dean and centennial professor of law. b.s., utah state university; j.d., university of utah college of law; ll.m., university of virginia school of law. eric dannenmaier, associate professor of law. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university (cand.). james d. dimitri, clinical associate professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer ann drobac, professor of law. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. george e. edwards, car/114. gray professor of law and director, program in international human rights law. b.a., north carolina state university; j.d., harvard law school. frank emmert, john s. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university of munich law school; ll.m., the university of michigan law school; ph.d., university of maastricht; diploma, european university institute. nicholas georgakopoulos, harold r. woodard professor of law. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. frances watson hardy, clinical associate professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. john lawrence hill, professor of law. b.a., northern illinois university; j.d., ph.d., georgetown university. linda kelly hill, m dale palmer professor of law. b.a., j.d., university of virginia. lawrence a. jegen, iii, thomas f. sheehan professor oft ax law and policy. a.b., beloit college; j.d., m.b.a., the university of michigan; ll.m., new york university school of law. henry c. karlson, professor of law. a.b., j.d., ll.m., university of illinois college of law. robert a. katz, professor of law. a.b., harvard college; j.d., university of chicago law school. eleanor d. kinney, hall render professor of law, co-director of the williams. and christine s. hall center for law and health and executive director, latin american law program. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. andrew r. klein, paul e. beam professor of law. b.a., university of wisconsin; j.d., emory university school of law. robert e. lancaster, clinical professor of law, director, chinese law summer program. b.a., millsaps college; j.d., tulane law school. norman lefstein, professor of law and dean emeritus. ll.b., university of illinois college of law; ll.m., georgetown university law school. maria pabon lopez, associate professor of law and director, latin american law program. b.a., princeton university; j.d., university of pennsylvania law school. gerard n. magliocca, professor of law. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor law. b.s., j.d., university of illinois. deborah mcgregor, clinical associate professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. mary h. mitchell, alan h. cohen professor of law. a.b., butler university; j.d., cornell law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. james p. nefif, cleon h. foust fellow and professor of law. b.a., knox college; j.d., university ofnorth carolina law school. david orentlicher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, associate professor of law. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kathleen patchel, associate professor of law. a.b., huntington college; j.d., university ofnorth carolina law school; ll.m., yale law school. michael j. pitts, associate professor of law. b.s.j., northwestern university; j.d., georgetown university law center. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. ruhtenberg, clinical professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university school of law-indianapolis. joel m. schumm, clinical associate professor of law. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university school of law­ indianapolis. lawrence p. wilkins, william r. neale professor of law. b.a., the ohio state university; j.d., capital university law school; ll.m., university of texas school of law. lloyd t. wilson, jr., associate professor of law and director, central and eastern european law program. b.a., wabash college; m.a., duke university; j.d., indiana university school of law-bloomington. mary t. wolf, clinical professor of law and director of clinical programs. b.a., saint xavier college; j.d., university oflowa college of law. r. george wright, lawrence a. jegen ill professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law-indianapolis. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university of nebraska; ll.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, iii, professor of law emeritus. a.b., j.d., m.a.l.s., the university of michigan. agnes p. barrett, associate professor of law emerita. b.s., j.d., indiana university. clyde harrison crockett, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. f alender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school of law-indianapolis. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of law emeritus. a.b., juniata college; j.d., george washington university law school william f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. william andrew kerr, professor of law emeritus. a.b., west university; b.s., duke university; j.d., ll.m., harvard law school. william e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., university of illinois college of law. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james w. torke, carl m gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. a.b., university oflowa; j.d., ll.m., george washington university law school. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. debra denslaw, reference librarian .. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnt!ng, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. chris e. long, catalog librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. steven r. miller, reference librarian. b.s., lebanon valley college of pennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh, acquisition/serials librarian. b.a., national university oflran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy, associate director of law libraty. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. k!yoshj otsu, automated and media services librarian. a.a., parkland college; a.b., m.s., c.a.s., university of illinois. indiana health law review volumes issue 2 table of contents articles a proposal for comprehensive biobank research laws to promote transnational medicine in indiana ...................... . jennifer girod strained application of the viability standard to in vitro frozen embryos-deconstructing jeter v. mayo katherine drabiak 217 clinic arizona .................................................... brock j. heathcotte 251 notes finally moving beyond the fiction: an overview of the recent state rally for health care reform .................... . mark e. douglas 277 attorneys, tell your clients to say they're sorry: apologies in the health care industry ... ........................... robin e. ebert 337 your money or your lifestyle!: employers' efforts to contain healthcare costs lifestyle discrimination against dependents ofemployees? .................................................. brendan w. miller 371 mandating the gardasil vaccine: a constitutional analysis ...................................................................... kyra r. wagoner 403 symposium healthcare reform in america: getting beyond ideology to true reform march 19, 2008 mcdonald-merrill-ketcham memorial award for excellence in law and medicine health care reform in america: beyond ideology .......................................... professor george j. annas 441 transcript of the 2008 live symposium panel discussion ....................................................................... james buechler, m.d. aaron carroll, m.d., matthew r. gutwein david orentlicher, m.d., eric schmitz, kevin speer 463 2008 microsoft word 1-masthead vol. viii.doc indiana health law review volume 8 2010-2011 editor-in-chief melissa l. stuart, m.s. executive managing editor bobby a. courtney, m.a. executive production editors matthew derringer paul jansen executive business editor katie miller executive notes editor amy e. halsey executive articles editor roxana bell executive symposium editor dennis mullen ______________ note development editors elizabeth eichholtz lucas mlsna allison neil deyoung vijay patel chad wilson, d.p.t. articles editors jennifer cooper kristin mccreary andrea white zach williams associate editors john brown kelly earls ______________ members erin albert, mba, pharmd alexander berger andrew breck ashley brian lesley brown courtney campbell kate cook brienne delaney kyle fairchild kyle johnson macon jones christopher kacarab alex krouse julie m. mahomed amber malcolm leeann simpkins beth pirro chris serak kate shelby joel d. swider ash lee talley amy tate, m.s.w. ellen winternheimer lance worland ______________ faculty advisors david orentlicher (chair) eleanor d. kinney (co-chair) robert a. katz emily morris miriam murphy (research liaison) indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2010-11 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university school of law – indianapolis. subscriptions. the current subscription rate is $20.00 for two issues (domestic mailing). unless the business office receives notice to the contrary, all subscriptions will be renewed automatically. claims for non-receipt of the current year’s issues must be made within six months of the mailing date. address changes must be received at least one month prior to publication to ensure prompt delivery and must include the old and new addresses and the proper zip code. manuscripts. the indiana health law review invites submission of unsolicited manuscripts. all citations should conform to the bluebook: a uniform system of citation (19th ed. 2010). manuscripts should 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health law review indiana university school of law – indianapolis attn: executive business editor lawrence w. inlow hall, room 136c 530 w. new york street indianapolis, in 46202-3225 questions? email: ihlr@iupui.edu phone: (317) 278-9519 www.indylaw.indiana.edu/~ihlr mailing address: name/title company/school address city state zip email payment method: enclosed (make check payable to indiana health law review) bill me later indiana international & comparative law review the indiana international & comparative law review, published by the indiana university school of law – indianapolis since 1991, is a student-edited law journal that provides a forum for the discussion and analysis of contemporary issues in public and private international law. the review publishes articles by prominent legal scholars, practitioners, and policy makers around the world, as well as studentwritten notes and comments. the review is published twice annually, with a symposium issue devoted to a specific topic of international or comparative law published intermittently. past symposium topics has included political and social aspects of italian law, various aspects of chinese law, and international terrorism in the twenty-first century. __________________________________________________________________ name __________________________________________________________________ school/firm/business __________________________________________________________________ address __________________________________________________________________ city, state, zip code subscriptions within the u.s. are $18.00 per year and outside the u.s. are $21.00 per year. i enclose $ _______ for _______ subscription(s) to the indiana international & comparative law review. please make your check payable to the indiana international & comparative law review. mail to: executive production editor indiana international & comparative law review lawrence w. inlow hall 530 west street indianapolis, in 46202-3225 _ _ _ _ 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bioethics • intellectual property law • international and comparative law • international human rights law featuring the health law, policy and bioethics track of the ll.m. program the william s. and christine s. hall center for law and health at iu law— indianapolis is widely acknowledged as one of the premier programs of its kind among u.s. law schools. • gain practical and theoretical knowledge in the areas of health law, policy and bioethics • learn about the institutions and structures of healthcare and how they affect the ethical issues that arise in medical and legal practices • enhance your opportunities for health law-related employment • courses offered: biotechnology antitrust and healthcare bioethics medical malpractice application deadlines fall semester: july 15 spring semester: october 15 www.indylaw.indiana.edu/llm indiana university school of law—indianapolis 2010-2011 administrative officers and faculty administrative officers michael a. mcrobbie, president of the university. ph.d., australian national university. charles r. bantz, chancellor, indiana university-purdue university—indianapolis. b.a., m.a., university of minnesota; ph.d., the ohio state university. gary r. roberts, dean and gerald l. bepko professor of law. b.a., bradley university; j.d., stanford university. paul n. cox, vice dean and centennial professor of law. b.s., utah state university; j.d., university of utah; ll.m., university of virginia. james p. nehf, associate dean for graduate studies and cleon h. foust fellow; professor of law and john s. grimes fellow. b.a., knox college; j.d., university of north carolina law school. jonna kane macdougall, assistant dean for external affairs and alumni relations. b.a., m.a., indiana university; j.d., indiana university school of law—indianapolis. johnny pryor, assistant dean for student affairs. b.a., wittenberg university; j.d., indiana university maurer school of law. chasity thompson, assistant dean for professional development. a.s., b.a., alabama state university; m.b.a., auburn university; j.d., indiana university school of law— indianapolis. mark v. wunder, assistant dean for development. b.s., j.d., university of iowa. elizabeth allington, director of communications and creative services. b.a., indiana university; m.a., m. phil., new york university. teresa (terri) j. cuellar, director of technology services. b.s., st. bonaventure university, new york. joyce m. hertko, director of major gifts. b.a., knox college; m.s., western illinois university; ph.d., indiana university. amanda kamman, director of fund raising and development services. b.a., indiana university. priscilla d. keith, director of research and projects, hall center for law and health. b.s., spelman college; m.s., atlanta university; j.d., indiana university school of law— indianapolis. patricia k. kinney, director of admissions. b.s., purdue university; j.d., indiana university school of law—indianapolis. virginia marschand, director of administrative and fiscal affairs. b.a., m.p.a., indiana university; j.d., indiana university school of law—indianapolis. sonja rice, egypt program director. b.a, purdue university; j.d., indiana university school of law—indianapolis. john r. schaibley, iii, executive director of the center for intellectual property law and innovation. b.a., purdue university; j.d., indiana university maurer school of law. lawanda w. ward, director of pro bono program and public interest. b.a., murray state university; m.a., illinois state university; m.s., old dominion university; j.d., indiana university school of law—indianapolis. jacob manaloor, associate director for contracts, grants and fund raising. b.s., indiana university kelley school of business; j.d., indiana university school of law— indianapolis. carlota toledo, associate director of student affairs. a.b., university of chicago; j.d., depaul university college of law. susie agnew, assistant director of student services. clark college. william j. baker, assistant director of technology services. susan bushue-russell, assistant director of administration and finance. a.a.s., lakeland college; b.s., eastern illinois university. karen h. miller, assistant director for admissions. midway college. lisa schrage, assistant director for donor relations. b.s., marian college. faculty cynthia m. adams, clinical professor of law and co-director of the latin american law program. b.a., kentucky wesleyan college; j.d., indiana university school of law—indianapolis. judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. cynthia baker, clinical associate professor of law and director, program on law and state government. b.a., j.d., valparaiso university. gerald l. bepko, indiana university-purdue university—indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. shawn boyne, associate professor of law and dean’s fellow. b.a., cornell university; m.b.a., university of minnesota, j.d., university of southern california’s gould school of law, m.a., university of wisconsin, l.l.m., justus-liebig-universtat. karen e. bravo, professor of law; john s. grimes fellow and dean’s fellow. b.a., the university of the west indies; j.d., columbia university school of law; ll.m., new york university school of law. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. chestek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law. daniel h. cole, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school. jeffrey o. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. eric dannenmaier, associate professor of law and dean’s fellow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university. james d. dimitri, clinical professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer a. drobac, professor of law and director, central and eastern european law summer program. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. george e. edwards, carl m. gray professor of law; faculty advisor to the ll.m. track in international human rights law (term ending, spring 2011); director, program in international human rights law and john s. grimes fellow. b.a., north carolina state university; j.d., harvard law school. frank emmert, john s. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university of munich law school; ll.m., the university of michigan law school; ph.d., university of maastricht; diploma, european university institute. nicholas georgakopoulos, harold r. woodard professor of law. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. carrie hagan, clinical associate professor of law. b.a., university of kansas; j.d., university of cincinnati, college of law. john lawrence hill, professor of law; adjunct professor of philosophy and john s. grimes fellow. b.a., northern illinois university; j.d., ph.d., georgetown university. linda kelly hill, m. dale palmer professor of law. b.a., j.d., university of virginia. max huffman, associate professor of law and dean’s fellow. b.a., cornell university, j.d., university of chicago college of law. lawrence a. jegen, iii, thomas f. sheehan professor of tax law and policy. a.b., beloit college; j.d., m.b.a., the university of michigan; ll.m., new york university school of law. robert a. katz, professor of law and john s. grimes fellow. a.b., harvard college; j.d., university of chicago law school. eleanor d. kinney, hall render professor of law, co-director of the william s. and christine s. hall center for law and health. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. andrew r. klein, paul e. beam professor of law; chief of staff, office of the chancellor of indiana university-purdue university—indianapolis. b.a., university of wisconsin; j.d., emory university school of law. norman lefstein, professor of law and dean emeritus. ll.b., university of illinois college of law; ll.m., georgetown university law school. maría pabón lópez, professor of law and dean’s fellow. b.a., princeton university; j.d., university of pennsylvania law school. gerard n. magliocca, professor of law; co-director, chinese law summer program and john s. grimes fellow. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor of law. b.s., j.d., university of illinois. deborah mcgregor, clinical professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law—indianapolis. emily morris, associate professor of law and dean’s fellow. a.b., harvard university, j.d., university of michigan law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. david orentlicher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, associate professor of law and dean’s fellow. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. michael j. pitts, associate professor of law; dean’s fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. peter a. prescott, associate professor of law. b.a., augustana college; m.s., the university of chicago; m.p.a., the university of texas at austin; j.d., the university of houston law center. fran quigley, visiting professor of law. b.a., hanover college; m.a., indiana university; j.d., indiana university school of law—indianapolis. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. ruhtenberg, professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university school of law—indianapolis. joel m. schumm, clinical professor of law and director, judicial externship program. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university school of law—indianapolis. carlton m. waterhouse, associate professor of law and dean’s fellow. b.s., pennsylvania state university; j.d., howard university school of law; mt.s., emory university, chandler school of theology; ph.d., emory university. frances watson, clinical professor of law. b.s., ball state university; j.d., indiana university school of law—indianapolis. lloyd t. wilson, jr., professor of law and co-director, chinese law summer program. b.a., wabash college; m.a., duke university; j.d., indiana university school of law—bloomington. mary t. wolf, clinical professor of law and director of clinical programs and externships. b.a., saint xavier college; j.d., university of iowa college of law. r. george wright, lawrence a. jegen iii professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law—indianapolis. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university of nebraska; ll.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, iii, professor of law emeritus and director of the law library emeritus. a.b., j.d., m.a.l.s., the university of michigan. clyde harrison crockett, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. falender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school of law—indianapolis. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of law emeritus. a.b., juniata college; j.d., george washington university law school. william f. harvey, carl m. gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law—newark. william andrew kerr, professor of law emeritus. a.b., west university; b.s., duke university; j.d., ll.m., harvard law school. william e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., university of illinois college of law. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university— bloomington. james w. torke, carl m. gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. lawrence p. wilkins, william r. neale professor of law emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., university of texas school of law. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. debra denslaw, reference librarian. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. catherine lemmer, head of information services. b.a., lawrence university; j.d., university of wisconsin; m.s., university of illinois. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. steven r. miller, reference librarian. b.s., lebanon valley college of pennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh, serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university—bloomington. kiyoshi otsu, automated services and media librarian. a.a., parkland college; a.b., m.s., c.a.s., university of illinois. indiana health law review volume 8 issue 2 table of contents the association of american law schools 2011 annual meeting: section on torts and compensation schemes symposium vaccines and drugs: a brave new tort world .............catherine m. sharkey 259 the vaccine no-fault act: an overview ............................... robert l. rabin 267 administrative compensation for pharmaceutical-and vaccine-related injuries ......................................................james r. copland 275 the case against preemption: vaccines & uncertainty ............ mary j. davis 291 the case for preemption: why the u.s. supreme court and the administration are wrong to curtail implied conflict preemption .........................................................malcolm e. wheeler 317 aals torts and compensation systems section william l. prosser award bestowed upon guido calabresi........................catherine m. sharkey 331 comments by the honorable guido calabresi, u.s. court of appeals, 2nd circuit ......................honorable guido calabresi 333 article perspective on economic critiques of disability law: the multifaceted federal role in balancing equity and efficiency............... elizabeth burleson 335 notes hospital tax-exemption and the community benefit standard: considerations for future policymaking ............................bobby a. courtney 365 focusing on fraud: the federal government expands its use of the false claims act to police off-label pharmaceutical promotion.................................................................. kristin mccreary eichel 399 nanotechnology: how voluntary regulatory programs can both ease public apprehensions and increase innovation in the midst of uncertain federal regulations ...................................................... katie miller 435 stem cell based treatments and novel considerations for conscience clause legislation..................................................... lucas mlsna 471 autism insurance reform: a comparison of state initiatives....melissa stuart 497 2011 microsoft word 1-masthead vol. viii.doc guido calabresi dear friends, as cathy will explain, it is not possible for me to be with you today. i did want, however, to tell you how much receiving the prosser award means to me. it makes me happy in a way no other award can. from the very beginning in the fall of 1959, torts has been my field. i have taught it every single year, either at yale or when i have visited at columbia, harvard, the university of cambridge, etc. and every year i have learned something new, from my students and from teaching them this wonderful subject. it never grows stale; it always gets deeper. i first fell in love with the subject fifty-five years ago in fleming james’s torts class. jimmy james was a great torts teacher, and all the other greats of the time: gregory, seavey―and prosser foremost among them―were part of the conversation almost every day. but there was also something else in the background which jimmy did not fully appreciate himself. the materials he used―what became the shulman & james casebook―had originally been put together by shulman and walton hamilton. jimmy james was not an economist, in any way, and shulman not much more. but walton hamilton certainly was. and, lurking in the materials were all sorts of questions that, as i’ve recently learned, hamilton put in, questions which invited an economist’s analysis that hamilton, who left torts very early for antitrust, never made. that interplay between hamilton’s and james’s visions of torts, between economics and everything else torts is concerned with, was made to order for me fifty-five years ago. it still is. i was fascinated then, and continue to be to this day. the prosser award that you have given me will spur me on to write more and continue to teach about the very special role that torts has in legal systems like ours. 334 indiana health law review [vol. 8:2 to join the extraordinarily wonderful, dear friends all, previous recipients in sharing prosser’s name, makes me glow with delight. to receive this award from you, dear friends, makes the pleasure even greater. thank you from the bottom of my heart. the honorable guido calabresi u.s. court of appeals, 2nd circuit bottom lines and waist lines: state governments weigh in on wellness cynthia a. baker• table of contents i. introduction .................................................................................... 185 ii. wellness ........................................................................................... 186 ill. state efforts explored ................................................................ 189 a. redistributive efforts ................................................................. 190 b. educational efforts ................................................................... 192 c. community design efforts ........................................................ 193 iv. conclusion ....................................................................................... 198 i. introduction this article springs from a unique aspect of my work. as the director of the program on law and state government ("plsg''), namely, serving as the fac­ ulty advisor for the plsg fellowship? the plsg fellows for 2007, mr. sam­ uel derheime~ and ms. sally hubbard4 chose wellness as the topic for their fellowship year. together, their questions, ideas, and work. resulted in the sev• clinical associate professor of law and director, program on law and state gov­ ernment, indiana university school oflaw -indianapolis; b.a., with distinction, 1998, valpa­ raiso university; j.d., magna cum laude, 1991, valparaiso university school of law. the program on law and state government thanks the indiana health law review for its support of the 2007 fellowship symposium and for continuing the dialog between state governments and the academic community with this issue. 2. awarded on a competitive basis, the plsg fellowships allow two students the oppor­ tunity to work together for one year exploring a topic of their choice concerning a critical legal issue facing state governments. working with the guidance of the director, fellowship respon­ sibilities have included hosting an academic event, collaborating to write an academic paper on the chosen fellowship topic, or contributing to policy development and analysis at the state government level. information on the plsg fellowship program is available at, program on law and state government: fellowships, http://indylaw .indiana.edulprogramsllaw _state _gov/ fellowships.htm (last visited apr. 8, 2008). 3. j.d. candidate, 2008, indiana university school oflawindianapolis; b.a., 2002, university ofnotre dame. 4. j.d. candidate, 2008, health law concentration, indiana university school oflaw­ indianapolis; m.ed., 2000, university of georgia; b.a., 1999, indiana university. 186 indiana health law rjmew [vol. 5:185 enth annual plsg fellowship symposium, wellness and the law: state gov­ ernments' role in addressing america's public health crisis.5 the symposium faculty included an economist, professor frank cha­ loupka, 6 who shared research regarding economic and health correlations be­ tween raising taxes and unhealthy behaviors such as smoking, alcohol consumption, and consumption of junk. food, two policymakers, professor ke­ vin ryan7 and joy rockenbach,8 who together successfully implemented a statewide plan using body mass index ("bmf') data as a way to combat obesity in school aged children;9 and indiana's deputy state health commissioner, mary hill, 10 who addressed the aggressive advertising campaigns of tobacco companies toward young women and an innovative public/private collaboration to combat that effort. also contributing to the day's discussion was exercise physiologist professor russell pate, who shared his research regarding, primar­ ily, how very little exercise america's children undertake compared to what they need and the health impacts of this statistic.11 the fellows also contrib­ uted their scholarship at the event. ms. hubbard addressed state efforts toward encouraging wellness through public education,.and mr. derheimer gave ale­ gal and political history of compulsory vaccination and health security. a panel comprised of professor eleanor kinney, 12 professor and indiana representative 5. the symposium was held on october 5, 2007, in the wynne courtroom of the indiana university school of lawindianapolis. 6. ph.d., 1988, city univeisity ofnew york; b.a, 1984, john carroll univeisity. dr. frank chaloupka serves as the distinguished professor of economics, in the college of busi­ ness administration and the director of the health policy center at the university oflllinois­ chicago. in addition to the expansive research and scholarship that dr. frank chaloupka has contributed to the area of taxing toward health, he has served as consultant to numerous gov­ ernmental agencies, private organizations, and businesses. 7. b.s., 1981, university of arkansas; m.a., 1996, webster univeisity, st. louis, mis­ souri (little rock campus); j.d., with high honors, 2001, university of arkansas at little rock william h. bowen school of law. 8. b.s.e., 1990, univeisity of central arkansas. 9. since its implementation in 2003, the arkansas bmi project has raised issues of pri­ vacy, public records, and complex issues of health law, state priorities, and racial and ethnic disparities in existing healthcare services. kevin ryan. exec. dir., ark. ctr. for health im­ provement univ. of ark. formed. sci. coli. of pub. health, address at the indiana university school of lawindianapolis plsg fellowship symposium: act 1220: arkansas's effort to use body mass index as a political tool (oct. 5, 2007) [hereinafter ryan address]. 10. b.s, summa cum laude, 1984, university of cincinnati; j.d., summa cum laude, 1995, indiana university school of lawindianapolis. 11. b.s., 1968, springfield college; m.s., university of oregon, 1973; ph.d., university of oregon, 1974. dr. russell pate currently serves as the associate vice president for health sciences and professor in the department of exercise science in the arnold school ofpublic health at the university of south carolina. widely published and well regarded as a scholar, author, teacher, and community leader, dr. pate has changed the way this country thinks about physical education, obesity, and children's health. in addition, he has competed in three u.s. olympic trial marathons and twice placed among the top finisheis in the boston marathon. 12. m.p.h;, 1979, universityofnorthcarolina;j.d., 1973,dukeuniversity;m.a 1970, 2008] bottom lines and waste lines 187 david orentlicher, 13 and ms. ellen whitt, 14 indiana's senior advisor on health promotion for indiana's governor mitch daniels, presented an update on indi­ ana's efforts toward wellness. i too presented remarks, which served as the seeds of this article. what are states doing to make their citizens less sick, less fat, and more well? what is the role of state government in incentivizing wellness? finally, what are the best tools states can use to improve their citizens' attitudes toward and abilities to live healthier lifestyles? part n of this article explores wellness and its current political landscape. part m explores some of the most innova­ tive ideas being tested by various state governments using redistributive, educa­ tional, and community design policy vehicles. in conclusion, i suggest that community design efforts may be the states' strongest suit in making a differ­ ence in our state of wellness. d. wellness this topic begs the question, ''what is wellness?" according to sted­ man's medical dictionary ''wellness" is defined as: a philosophy of life and personal hygiene that views health as not merely the absence of illness but the full realization of one's physical and mental potential, as achieved through positive attitudes, fitness training, a di­ et low in fat and high in fiber, and the avoidance of un­ healthful practices (smoking, drug and alcohol abuse, overeating).15 like rainbows and puppy dogs, it's easy to be in favor of, and downright diffi­ cult to be against, wellness so defined. however, in the world oflaw and poli­ tics, wellness applied is not always so painlessly loved. the political landscape of wellness has many interesting features, but i will briefly describe just a few revealing characteristics of that landscape. on one end of the continuum, we see the groups asserting that "states retain the ultimate responsibility for protecting the health of their citizens."16 these university of chicago; b.a., 1969, duke university. eleanor kinney is the hall render profes­ sor of law and co-director of the williams. and christine s. hall center for health, indiana university school of law indianapolis, indiana. 13. j.d., 1986,harvardschool oflaw;m.d.l981,harvardmedica1school;b.a., 1977, brandeis university. dr. david orentlicher is the samuel r. rosen professor oflaw and co­ director of the william s. and christine s. hall center for health, indiana university school of law indianapolis, indiana. 14. j.d., 1988, george washington universitynationallawcenter;b.a., 1984,augus­ tana college. ellen whitt is the senior advisor on health promotion and special projects for indiana's govenor daniels, office of the governor. 15. stedman's medical dictionary 1960 (28th ed. 2006) (hereinafter stedman's]. 16. douglas scutchfield & william keck, principaui of pubuc healm practice 120 188 indiana health law review [vol. 5:185 groups maintain that, taken together, stress, obesity, and illness decrease pro­ ductivity and add to the costs of healthcare, doing business, and running the nation. 17 a recent study by the u.s. centers for disease control and preven­ tion and the american diabetes association asserts that this nation's unchecked diabetes epidemic costs our country $174 billion a yearabout, according to the study, the same amount as the conflicts in iraq, afghanistan, and the global war on terrorism combinedmore than the $150 billion in damage caused by hurricane k.atrina.18 for these groups, encouraging wellness would seem to be an essential element of any answer to states' health and fiscal woes. as a result, these groups align themselves with research indicating that a majority of americans believe that the government should actively address the obesity crisis, and contend that state governments should utilize educational programs to promote healthy living.'9 these groups have had tremendous suc­ cess inspiring state and local governments throughout the nation to ban smok­ ing, ban or discourage the consumption of trans fats, and promote bully pulpit encouragement of exercise and eating right 20 it would seem, therefore, that if (1997). scbutchfield and keck also note that while the kderal government has the most money to dedicate to the protection of public health, local governments have most of the responsibility for protecting the health of the people, and state governments have most of the legal authority to do so. ld. at 119. 17. victoria colliver, chronic rlness costs the economy more than $1 trillion a year, s.f. chr.on., oct. 3, 2007, available at http://www .sfgate.com/cgi-bin/article.cgi?f-=/c/a/2007 i i 0/03/ budksgjlp .dtl (last visited apr. 8, 2008). see marlc winne, replenishing our food deserts: more ways to re-store our communities, 33 state legislatures 26, 28 (2007) (''obesity and obesity-related diseases cost the golden state [california] some $20 billion a year •.• .''). see also 2002-2003 state health expenditure report, rep. (milbank mem'l fund, n.y., n.y.), june 2005, available at http://www.milbank.orglreports/05nasbo/index.html (comparing state spending on healthcare by type and region) (last visited apr. 8, 2008); total state government health expenditures as percent of the gross state product, 2003, rep. (the henry j. kaiser fam. found., menlo park, cal.), june 2003, http://www.statehealthfacts.org /compare maptable.jsp?cat=5&ind=284 (comparing the total state government health expendi­ tures, as a percentage of gross state product, for all u.s. states in 2003) (last visited apr. 8, 2008). 18. see generally am. diabetes ass'n, economic costs of diabetes in the u.s. in 2007, 31 diabetes care 3, 596 (2008). 19. new report finds u.s. obesity epidemic continues to grow; mrssissippi tops list for adults, d.c. for youths, rep. (trust for am. health, washington, d.c.), aug. 2007, at 2, available at http://healthyamericans.orglnewsroomlreleases/release082707.pdf ("eighty-one percent of americans believe that the government should have a role in addressing the obesity crisis. majorities strongly support government working on proposals to expand education pro­ grams about healthy living, provide low-cost access to exercise programs, and reduce the mar­ keting of unhealthy foods.''). 20. tobacco control: state laws restricting smoking in public places and workplaces, summary rep. (am. lung ass'n), mar. 2008, http://slati.lungusa.orglappendixa. asp (listing states with laws restricting smoking in public places, government buildings, and private work places) (last visited apr. 8, 2008); nat'l conference of state legis., trans fat and menu labeling legislation (2008), http://www.ncslorg/programs/healtb/trans fatmenulabeling­ bills.htm (listing proposed and enacted state legislation relating to trans fat bans and restrictions and proposed state legislation relating to the inclusion of trans fat information on menus) (last 2008] botiom lines and waste lines 189 any state governments should be paying attention to the bottom line and waist line data upon which these groups build their policy positions, they should in­ clude the states where many of the indiana health law review's readers live and work, indiana and the midwestern states genemlly, smack ih the middle of, as one author put it, "america's obesity belt.'m on the other end of the political spectrum, groups such as restaurant asso­ ciations, industrial and agricultural corporate business interests, anti-tax move­ ments, and civil rights advocates, assert that government initiatives in this area are wholly invasive, ineffective, unnecessary, and inappropriate.22 these groups imply that at best, in the dynamic tension between the promotion of public wellness efforts and personal liberties, government wellness initiatives compromise citizens' individual rights and individualism while needlessly cut­ ting away at the profit margins of corporate america. at worst, they imply that to the extent government supported wellness initiatives ostracize, isolate, and punish the obese, smokers, and otherwise unhealthy individuals, those initia­ tives should be doubly criticized because such paternalism is not properly the province of government, especially when it results in the expenditure of tax­ payer dollars. rather, these groups seem to suggest that our governments and state governments in particular have bigger fish to fiyor poach or steam or something! issues such as unemployment, prison overcrowding, environmental degradation, and obtaining cost effective treatments for ''real" illnesses, should, they aver, take precedence over the governmental promotion and subsidization of wellness. these groups also point to the second half of the medical dictionary's de­ finition of wellness indicating that wellness programs "tend to attract persons already attuned to healthful attitudes and practices. little clinical evidence ex­ ists to support their usefulness or justify their expense. "23 as a side note, these groups have been, in my opinion, quite effective at coining catchy phrases de­ scribing the wellness advocates oftoday's world. "grease police," "calorie cops," and "exercise radicals" are among my favorites. ill. state efforts expwred state government efforts to encourage wellness can be categorized into three types: redistributive efforts, educational efforts, and community design visited apr. 8, 2008); nat'l conference of state legis., weuness overview (2007), http://www.ncsl.org/ programslhealtb/wellnessoverview .htm (listing states with state sponsored citizen and employee wellness programs and wellness initiatives mandated by state statute) (last visited apr. 8, 2008). 21. michelle conlin, get healthy or else: inside one company's all-out attack on medi­ cal costs, businessweek, feb. 26, 2007, at 58, 60. see also kelley holland, wellness pro­ grams try to be welcoming, too, n.y. times, july22, 2007, atb17. 22. see generally radley balko, does obesity justify biggovernmeill?, 55 the freeman 29, 29-34 (2005), available at http:/lwww.fee.org/pdflthe-freeman/0510balko.pdf. 23. stedman's, supra note 15, at 1960. 190 indiana health law review [vol. 5:185 efforts. undoubtedly, state governments will need to use all three of these tools to change a culture in which overeating, under moving, and smoking ourselves sick (if not to death), has become the accepted norm. ultimately, the manner in which state governments succeed in legislating toward wellness will provide a gauge as to how states are drawing some of the many lines between individual liberty and government authority. a. redistributive efforts redistributive efforts are legislative responses that raise money through taxing the general public and spending the money toward specifically desig­ nated legislative ends. 24 state governments are often "assigned the role of re­ distributing wealth throughout society in order to ensure that those worst off in the society do not fall below a given baseline.'.25 for example, imposing snack taxes can discourage the consumption of junk food and create a new revenue stream for health-minded initiatives such as supporting state health programs, additional health inspections, or state contributions to medical, dental, and nurs­ ing schools.26 while the positive effects of the revenue streams created by these snack taxes virtually vanish when compared to the economic costs of diet­ related diseases, "conservatively estimated to be at least $71 billion annually," the recurrent rise and demise of these snack taxes illustrates the democratic ten­ sion between protecting the public health and protecting the private coffers. 27 24. see generally nathan newman. j. mijin cha. & adam thompson. taking the lead: an interim report on state legislative successes in enacting progressive policy,interim rep. (progressive states network, n.y., n.y.), june 2007, at 7-10, available at http://www.prog ressivestates.orglfiles/statereport.pdf. the most obvious example of states using public tax dol­ lars to improve and create a well citizenry is the efforts aimed at increasing the scope and breadth of health benefits available to those who cannot afford private health insurance. over the past year and a hal~ twenty-nine states have enacted or considered healthcare expansions aimed at children. many initiatives expand eligibility for the state children's health insurance program ("schip") to 3000.4 (and some for up to 400%) of the federal poverty level. as a point of reference, a state permitting coverage for a family at 300% of the poverty level would allow a family of four with a household income of $60,000 to apply for coverage. a state permitting coverage for a family at 400% of the federal poverty level would allow a family of four with a household income of up to $82,600 to purchase the public coverage at full cost, which is ex­ pected to be cheaper than private coverage. in addition. these state efforts are accompanied by others seeking to ease administrative barriers to enrollment and improve outreach to ensure that eligible children are signing up. indiana expanded schip to families at or below 300% of the poverty. id. 25. lynn a baker & clayton p. gillette, local government law 45 (2004). 26. michael f. jacobson & kelly d. brownell, small taxes on soft drinks and snack foods to promote health, 90 am. j. pub. health 854, 854-57 tbl.l (2000). see also frank chaloupka, dir., univ. ofll. at chi. health pol'y ctr., address at the indiana university school oflaw ~indianapolis plsg fellowship symposium: the economics oft axing toward health (oct. 5, 2007) (on file with the author) [hereinafter chaloupka address]. 27. jacobson & brownell, supra note 26, at 854-57. 2008] boitom lines and waste lines 191 at least nine states have repealed such snack taxes in recent years. 28 most of these repeal& were at the behest oflarge soft-drink companies and snack food corporations as a part of negotiations to build or retain one or more manufactur­ ing facilities within the respective states.29 one noteworthy effort by bottling companies occurred in ohio, where, in 1994, a $0.008 per oz. tax on carbon­ ated beverages was repealed by amending ohio's constitution after a seven mil­ lion dollar advertising campaignfunded by the soft drink industryto defeat the tax.30 this example illustrates a common theme in states' redistributive efforts regarding wellness: corporate investment in a state government, along with the jobs, income, and wealth that companies bring with them, often holds sway over modest and well meaning state efforts to tax their citizens toward healthier choices. clearly, the voice of the private corporate market can be more power­ ful than the voices ofhealth advocates and state governments combined. scho­ lars point out that when state governments are strapped for tax revenue and development funds, they often find themselves "compet[ing] for resources to the detriment of the public they are supposed to serve."31 studies show consistent evidence that a variety of health behaviors re­ spond to changes in prices. higher taxes which increase prices can induce cur­ rent smokers to quit, prevent young people from becoming regular smokers, reduce drinkingparticularly heavy/binge drinking and drinking among young peopleand increase the likelihood of healthy eating. 32 in addition, imposing such taxes can raise significant new revenues that can then be used to support other efforts to improve health and wellness. according to research by profes­ sor frank chalupka, arguments about the adverse economic consequences of those efforts are, therefore, either false or overstated 33 on the other hand, corporate america, with and without state government intervention or incentives, provides all sorts of health and wellness benefits to its employees and their families. research shows that "more than half of all large companies [in the u.s.] offer some combination ofbenefits such as nutri­ tion education, weight management assistance, health risk assessments, and help quitting smoking. moreover, more than a quarter offer things like fitness coaching and discounts on health club memberships."34 so, to the extent that 28. id. 29. id. at 855-56 tbl.2. 30. i d. but see, school district, coke sign $350,000 deal, indianapous star, feb. 2008 (on file with the author) (noting recent efforts by a major soda company to provide healthier alternatives and other incentives toward a healthier school environment through private contact rather than public law). 31. see richard thompson ford, beyond borders: a partial response to richard briffault, 48 stan. l. rev. 1173, 1183 (1996). 32. chaloupka address, supra note 26. 33. /d. 34. holland, supra note 21, at b17. 192 indiana heal til law review [vol. 5:185 redistributive efforts are influenced by business interests, states should, at the very least, be mindful that some business interests may serve public wellness goals more than others and, when possible, take that into consideration when courting new corporate investment. b. educational efforts given the political costs of even modest redistributive efforts toward wellness, it is hard to expect states to act more aggressively when faced with the even more slippery and tangential effects of educational efforts. as a result, most state efforts to reach out and educate and encourage toward wellness are relatively low budget public/private motivational endeavors. 35 statewide well­ ness programs for all citizens share characteristics such as providing web based resources for information about the benefits of eating right, exercise, and other healthy behaviors, community programs and events, smoking cessation initia­ tives, and awards and prizes available to citizens who participate in the program or attain particular results. 36 more targeted efforts aim to educate their citizenry at key decision making points between healthy or unhealthy choices, such as at the time of food selection in restaurants. fourteen states and four major cities in the u.s. have already introduced laws and regulations requiring that caloric information about food purchased be made more apparentthat is, either post­ ed on menu boards or on the menus of the restaurants themselves.37 new york city ("nyc") used its regulatory powers to require restaurants that have already made public the number of calories in standardized menu items to take the next step and make that number ( 540 calories for a big mac, in case you were wondering) "readily available" to consumers as they choose food items. 38 nyc justified its regulation by noting that "an obesity epidemic 35. see whitt, supra note 14 (highlighting remarks by ellen whitt, senior advisor on health promotion and special projects for indiana's governor mitch daniels). 36. compare inshape indiana's ready, set, walk! homepage, www.in.gov/inshapel (last visited apr. 21, 2008) (describing indiana's wellness initiative), with healthy arkansas: for a better state ofhealth homepage, www .arkansas.govlhalhome.html (last visited apr. 21, 2008) (describing arkansas's wellness initiative), healthy hawaii: start living healthy homepage, www.healthyhawaii.com/ (last visited apr. 21, 2008) (describing hawaii's wellness initiative), building a healthy north dakota homepage, www .healthynd.org/ (last visited apr. 21, 2008) (describing north dakota's wellness initiative), healthy ohio homepage, healthyohiopro­ gram.org/ (last visited apr. 21, 2008)( describing ohio's wellness initiative), and the vermont governor's council on physical fitness and sports homepage, www.vermontfitness.org/ (last visited apr. 21, 2008) (describing vermont's wellness initiative). 37. see ian mount, would you eat 2,900-calorie cheese fries?, fortune: small business, apr. 29, 2008, http:l/money.cun.com/2008/04/24/smbusiness/full_disclosure_ menu.:&b/index.htm (last visited apr. 30, 2008). see generally new york state restaurant ass'n v. new york city bd. of health, 509 f.supp.2d 351, 351 (s.d.n.y. 2007); new york state restaurant ass'n v. new york city bd. of health, no.08civ.looo(rjh), 2008 wl 1777479 (s.d.n.y. 2008). 38. bonnie booth, new york city wants calories put on menus, amnews, sept 10, 2008] botiom lines and waste lines 193 threatens the health of new yorkers. "39 raising federal preemption and first amendment concerns, the new york restaurant association sued to stop the city from enforcing the regulation and won.40 the city's board of health has since retracted the calorie reporting provision, aiming to overcome the preemp­ tion concems.41 the revised rule, like its predecessor, requires the posting of calorie information at the point of selection in fast food chain restaurants.42 like its predecessor, the revised rule has also been challenged by the new york state restaurant association.43 whether new york city's struggle will bring a quiet end to calorie information education efforts in other states and cities, or if it is just a bump in the bike trail, remains to be seen. c. community design efforts community design efforts provide another way for states to legislate to­ wards wellness. working with private businesses, not-for-profit organizations, economic development teams, and local governments, states remain in a unique position to physically reshape communities in ways that are good for public coffers, private balance sheets, and the personal health of the states' respective citizens. i suggest that community design efforts might be the most politically and legally viable tool to legislate toward wellness. examples of statewide community design based initiatives include smok­ ing bans,44 water fluoridation mandates,45 and infrastructure improvements that 2007. 39. ld. 40. new york state restaurant ass'n v. new york city bd. of health, 509 f.supp.2d 351, 351 (s.d.n.y. 2007) (relying on pre-emption, the trial court did not address the first amendment arguments); new york state restaurant ass'n v. new york city bd. of health, no.08civ.1000(rjh), 2008 wl 1777479 (s.d.n.y. 2008) (denying restaurant association's motion for preliminary inj"imction and granting city's motion for summary judgment on the issue of preemption and denying restaurant association's motion for stay of enforcement pending ap­ peal). 41. dep't of realm & mental hygiene, res. to repeal & reenact § 81.50 of the n.y. cityheal1hcode (as passed by the nyc dep't ofhealth, jan. 22, 2008). 42. id. 43. press release, statement from n.y. city health dep't regarding court case on ca­ lorie posting regulation (mar. 27, 2008), available at home2.nyc.govlhtml/doh/htmllpr2008/ pr023-08.shtml (last visited apr. 21, 2008). 44. statestats: smoke free laws, 33 statelegislatijres 7, 7(sbaronrandalled.)(july 2007). most states in the northeastern u.s., with the exception ofpennsylvania, and most states in the west and south west, and three states in the midwest (minnesota, lllinois, and ohio) re­ quire most workplaces, including restaurants and bars, to be smoke free. nine states, mostly in the west and south, ban smoking from all or most restaurants and most workplaces, but exempt some bars and restaurants from the statewide ban i( for example, the bar or restaurant does not admit patrons under age eighteen or twenty-one. more than one third of all states including indiana considered banning smoking in cars with children in 2007. only two states, arkansas and louisiana, have passed such statewide bans. ld. 45. megan foreman, children's oral health, 15 ncsl legisbrief 1, 1 (aug. 2007). "according to the center for disease control (cdc), water fluoridation ... is one of the 10 194 indiana health law review [vol. 5:185 encourage people to live healthier lives.46 states have plenary power to recali­ brate the state and local power structure to require local governments to address local land use, zoning, and planning issues with an eye toward making it easier to be physically active by walking and biking in, around, and·among various local governments. of course, these ideals automatically trigger traditionally very local burdens such as public safety concerns, the cost of parks and recrea­ tion programs, and, of course, the basic infrastructure necessary for linear parks and trail systems between neighborhoods and towns. but these are the very areas where state governments have the most power to act and to fund collabo­ rative regional solutions. ms. hubbard's comment, taking roll: an assessment ofstate and local governance of school wei/ness policies, which also appears in this issue of the indiana health law review, explores the potential power of such regional solu­ tions to enhance wellness by discussing how state funding formulas, educa­ tional standards, and legislation, have the power to positively impact the physical environment within our nation's schools.47 indeed, ms. hubbard theo­ rizes that by establishing nutritional standards for school lunches (with higher criteria than currently mandated under federal law), banning food courts and competitive foods from schools, increasing nutrition education and physical activity standards for all grade levels, decreasing screen time for kids in school, promoting walking to school, and creating bmi data driven initiatives, state legislatures could dramatically and positively impact the health and wellness of america's future generations.48 parallel community design wellness efforts at the local and state govern­ ment level include: improving regional and local zoning laws to accommodate trails and sidewalks, encouraging wellness based economic development, and supporting urban planning efforts that reduce the role of the automobile. could increased access to medical care or fresh food result in measurable health im­ provements? can discouraging the availability of fast food encourage healthier personal diet choices? some state and local governments are willing to imple­ ment these sorts of community design efforts in the hopes that they will. new jersey led the way toward marrying a concept familiar to state gov­ ernments, enterprise zones, to a public health initiative when it passed the health enterprise zone act in 2004.49 ''the health enterprise zone act en­ ables the state commissioner of health ... to designate medically underserved greatest public health achievements of the 20th century." still, even with cdc data reporting that every dollar invested in fluoridation saves thirty-eight dollars in avoided dental treatment costs, only eleven states mandate statewide water fluoridation. id. 46. ryan address, supra note 9. 47. sallyhubbard,comment,takingroll:anassessmentofstateandlocalgovernance of school wellness policies, 5 ind. healrnl. rev. 201,201 (2008). 48. ld. 49. see, e.g., new jersey health enterprise zone act, 2004 n.j. laws ch. 139. see also comm. on suggested state legis., health enterprise zones, 66 suggested state legislation 56, 56 (2007) (hereinafter health enterprise zones]. 2008] boti'om lines and waste lines 195 areas as health enterprise zones (hezs) and to offer financial incentives to doctors and dentists to practice in an hez/'50 such financial incentives include a reduction of income tax owed (based on the proportion of the health profes­ sionals' gross receipts "from providing health care services to eligible recipients of the medicaid program and [new jersey's] state familycare program"), the opportunity to apply for low interest loans "administered by the state economic development authority," and, under certain circumstances, an exemption from real property tax if the municipality in which the hez is located passes an ordi­ nance to that effect. 51 other health zoning efforts afforded by state law include south l.a.'s re­ cent consideration of a "moratorium of up to two years on new fast-food restau­ rants in south l.a."52 thirty percent of adults and twenty-nine percent of children in south l.a. are obese, compared to twenty one percent and 23.5%, respectively, of adults and children in the county. 53 of course, questions ab­ ound regarding whether local zoning laws that target obesity saturated areas in this manner can withstand legal challenge. pennsylvania and new mexico are leading community design efforts aimed at increasing access to healthy food by creating better food supply sys­ tems. 54 recognizing that access to fresh produce and meat is a basic need, state legislatures and local governments are turning to the task of reducing the size and number of "food deserts" places that, "compared to more prosperous communities, are underserved by affordable, high quality retail food outlets."55 for families living in these food deserts, it is ultimately too expensive, too diffi­ cult, and too time consuming to have fresh healthy food in the refrigerators and cupboards. 56 providing access to fresh food in urban and rural food deserts, however, requires significantly different solutions to the same problem. 57 pennsylvania's approach, the fresh food financing initiative, of 2004 ("fffi"), has encouraged public and private funding for supermarket develop­ ment across that state.58 to date pennsylvania's fffi, "has committed re50. health enterprise zones, supra note 49, at 56. 51. id. 52. council mulls limiting fast food in south l.a., indianapolis star, sept. 16,2007, ata4. 53. /d. 54. see generally mark winne, replenishing our food deserts: more ways to re-store our communities, 33 state legislatures 26, 26-28 (2007). 55. winne, supra note 54, at 26. 56. ld. 57. see generally id. 58. /d. at 26. in a collaborative effort between the state, a development finance corpora­ tion, a nonprofit organization, and the greater philadelphia urban affairs coalition, pennsyl­ vania has committed thirty million dollars that the initiative as a whole can use to leverage other private and public dollars for supermarket development. the fresh food financing initiative has committed resources to twenty eight projects that have produced more than a million square feet of retail food space and 2500 new jobs. /d. 196 indiana health law review [vol. 5:185 sources to 28 projects that so far have produced more than a million square feet of retail food space" in urban "food deserts" across the state ofpennsylvania. 59 a similar effort is underway in new mexico and seeks to direct state funds to­ ward getting affordable fresh food and produce to rural communities in that state. 60 in new mexico, the region's only independent food wholesaler is based in amarillo, texas, a situation which potentially poses a problem for food sell­ ers attempting to reach potential customers in rural new mexico. 61 "if a store doesn't have a loading dock, for example, it's just too costly'' for the wholesaler to make a delivery.62 while the new mexico effort is still in the ''task force" stage, it will likely result in "a state-financed revolving loan fund that helps cash strapped store owners in rural areas purchase produce coolers or even loading docks" to avail the stores, and the people living in the food deserts, to a wider and lower priced selection of fresh food. 63 other state initiatives aimed at improving the fresh food supply system in­ clude state supported training and technical assistance for store owners new to the produce business, offering financial incentives to food stamp recipients to buy fresh fruits and vegetables, and giving farmers a personal property tax ab­ atement on farm equipment if they sell produce at farmers' markets in under­ served communities. 64 additionally, state efforts have not ignored the communities in which americans spend more than half of their waking hours: the workplace. some states are exploring, but none has passed into law, policies requiring that em­ ployers guarantee some number of paid sick days per year, allowing employees to remain home when sick or to care for a loved one who is ill. 65 at the local level, for example, "san francisco has already enacted a city-wide paid sick days law, and family advocates and their allies will [continue] fighting for enactment of statewide versions ... .'.66 san francisco's approach is not unique. earlier this year, "oregon followed seven other states in at least allow­ ing those workers who have sick day benefits to also use them to care for a sick child or parent.'.67 59. id. 60. id. at 27 ("[1]he task force's recommendations will be presented at the 2008legisla­ tive session" and n.m state representative manual herarra foresees something more modest than pennsylvania's fffi.). 61. winne, supra note 54, at 28. 62. id. 63. id. 64. id. 65. newman, cha, & thompson, supra note 24, at 5 ("the connecticut senate approved a paid sick days bill. becoming the first chamber in the nation to do so, but the bill failed to pass the connecticut house before the session ended."). 66. ld. 67. id. 2008] botiom lines and waste lines 197 another workplace related state effort imposes smoking bans more broad­ lyand indirectlyby allowing employers to ban leisure time smoking.68 this sort of ban not limited to the geographic spaces of a workplace or a public place is the subject of state legislation that to date has made far fewer head­ lines. by allowing employers to enforce a non-smoking policy as a part of their hiring and retention processes, states allow those employers who choose to, to both test employees for nicotine and fire those with the drug in their system. 69 for example, massachusetts is one of twenty-three states allowing em­ ployers to penalize employees and potential employees for smoking during non­ employment hours. 70 in the fall of 2006, just two weeks after beginning his work as a lawn care technician for scotts miracle gro, scott rodriquez was fired for failing a drug testfor nicotine. 71 mr. rodriquez has filed a law suit in federal court in massachusetts alleging inter alia illegal discrimination.72 the suit also seeks to prohibit scotts from enforcing or applying its anti­ nicotine program. 73 the suit is still in its preliminary stages; but, on january 30, 2008, the district court dismissed all counts relating to the plaintiffs allega­ tions of wrongful termination and civil rights violations for failure to state any claim upon which relief could be granted. it appears, however, that mr. rodri­ quez will have the opportunity to prove his allegations regarding invasion of privacy and unlawful discrimination under the employee retirement income security act in court. 74 other states including indiana prohibit employers from discriminating against any current or prospective employee based on employee use of tobacco products outside the course of employment. 75 but while the rodriquez case could not happen in indiana under current state law, last year indiana's general assembly clarified indiana's statutory approach in this area by allowing em68. see generally karen l. chadwick, is leisure-time smoking a valid employment con­ sideration?, 70 alb. l. rev. 117, 117 (2006). 69. see id. at 130. 70. conlin, supra note 21, at 60. "today, scotts is in the vanguard of companies seeking to monitor and change employee behavior." id. worldng with a boutique law firm, scotts hired a private health management firm to provide on-site primary care and fitness centers for its em­ ployees. scotts built a five million dollar, 24,000 square foot filcility across the street from its headquarters where employees can obtain almost any primary medical or health intervention necessarythe facility employs two full-time doctors, five nurses, a dietician, counselor, two physical therapists, a team of fitness coaches, and includes a drive-tbru pharmacy. id. 71. id. 72. id. 73. rodrigues v. scotts co., llc, 2008 wl 251971 (d. mass., 2008). 74. id. 75. see, e.g., indiana's private tobacco protection act, ind. code.§ 22-5-4-1 (2007). "currently, twenty-seven states and the district of columbia have adopted statutes which pro­ hibit enforcement of employment policies that penalize employees and potential employees for engaging in legal activities such a smoking during non-employment periods." chadwick, supra note 68, at 117. 198 indiana health law review [vol. 5:185 players to "implement financial incentives intended to reduce tobacco use and related to employee health benefits provided by the employer."76 iv. conclusion state governments' active interest and support of wellness necessarily raises important issues regarding government priorities, discrimination, the rights of free speech and association, and individual choice. an integrated re­ sponse requires that states use redistributive, educational, and community de­ sign efforts to encourage wellness. however, it seems that states can be the most effective when they actually work to change the physical community. that is, states' efforts will be the most effective when they concentrate on limit­ ing or eliminating smoking, giving local governments additional tax breaks and incentives to create streets with room to walk, bike, and run, and encouraging businesses in both rural and urban communities to have fresh foods available for purchase. as state governments tty to improve environments plagued with an over abundance of non-nutritious food, obesigenic factors, and a lack of alternatives to sedentary ways to work and play, they face important political and fiscal choices. in so doing, state and local governments and their respective policy makers may find guidance in abraham lincoln's words of more than a centwy ago. in 1848, abraham lincoln said, "there are few things that are wholly evil or wholly good. almost everything, especially of government policy, is an in­ separable compound of the two; so that our best judgment of the preponderance between them is continually demanded/'77 in lincoln's day, america was in the midst of the industrial revolution, people lived in urban areas in previously unseen numbers, and slums and disease were an inextricable part of what it was to live in the poor areas of cities. 78 death and disease were "a daily fact for the people in the worst tenement districts."79 today, americans' health and wellness are still adversely affected by the conditions of the day. however, :fresh food deserts, sedentary lifestyles, and an overabundance of inexpensive, highly caloric food have largely replaced the cesspools, overcrowding, and diseases of the mid-19th centwy. still, president lincoln's words resonate as we, as citizens, lawmakers, lawyers, parents, edu­ cators, and judges, make our ''best judgments" about the preponderance be­ tween good and evil when it comes to encouraging wellness. while public health has proved a powerful basis for legal reform, public wellness is on much less stable ground. the legal, political, and economic questions surrounding 76. § 22-5-4-1. 77. the collected works of a.blt.ahamlincoi.n 484 (royp. baslered.)(l953){quot­ ing representative abraham lincoln's. remarks in the house, june 20, 1848). 78. dorothy deneen volo&jamesm. volo,dailylifeincml waramerica 9(1998); michael j. varhola, everydayl!fedulung1heclvn. war 62-73 (1999). 79. id. at69-71. 2008] botiom lines and waste lines 199 state governments' interventions in wellness will surely be with us for a while. as cheerleaders,·. administrators, tax collectors, or architects of local govern~ ment, state governments have lots of ways to weigh in and make a difference in the bottom lines and waist lines of our communities. i laud the work of the 2007 fellows, mr. sam derheimer and ms. sally hubbard, for their contribution .to what was a terrific symposium, a symposium which inspired us to think about not only state governments' role, but our own, in addressing whether and how states confront this work. the patient safety and quality improvement act of 2005: an invitation for sham peer review in the health care setting leigh ann lauth* table of contents i. introduction ............................................................................... 152 ii. reduction of medical errors as the primary motivation behind the psqia operations­ based medical errors and adverse events in hospitals .................................................................................. l53 a. operations-based medical errors and adverse events in hospitals ................................................................... 154 b. medication-related errors ....................................................... 155 til the patient safety and quality improvement act of 2005 ................................................................................... 156 a. background .............................................................................. 156 b. initial public perceptions ......................................................... l57 c. the functional purpose of the psqia ..................................... 158 d. congressional debates concerning the psqia ....................... 158 e. the main "players" ofthe psqia ........................................... l60 f. the reporting system ............................................................... 161 1. privilege provision ............................................................ 162 2. confidentiality provision ................................................... l63 n. will the patient safety and quality improvement act of 2005 achieve the results congress intended? .................................................... 163 a. anticipated underutilization of psos by providers ................. 164 b. likely development of bad faith or sham peer review .......... 166 1. a look at state peer review protection statutes that have been used in good faith ................................. l66 2. sham uses of peer review statutes and policies .............. 167 a. the semmelweis society and protecting physicians from sham peer review .............................. 169 v. conclusion ................................................................................... 171 * j.d., 2006, indiana university school of law, indianapolis, indiana; b.a., 2003, de­ pauw university, greencastle, indiana. thanks to professor eleanor kinney for her direction and insight on this important topic and kevin r. o'neill for challenging my arguments and provoking me to cogitate about them more carefully. 152 indiana heal1h law review [vol. 4:151 i. introduction out of the many noteworthy epidemics facing the health care world today, two of specific relevance to patient safety and quality improvement emerge: medical error and sham peer review. when congress passed the patient safety and quality improvement act of2005 ("psqia") its main intention was tore­ duce the number of deaths due to medical error that occur in the united states annually.1 unfortunately, in pursuit of this goal, congress created the frame­ work for an unintended side-effect, malevolent or sham peer review. part ii of this note discusses the institute ofmedicine's ("10m'') report, to err is human: building a safer health system, which serves as the basis for the psqia. 2 critically, this report uncovers that as many as 98,000 people die each year in america due to medical errors? these errors vary from prevent­ able adverse events, such as operations performed on the wrong body part, to medications administered in poisonous doses. based on these and similar find­ ings, the 10m recommended in its report that a national voluntary reporting system be developed as a forum of analysis to which health care providers can report their medical errors. 4 part iii of this note describes the psqia itself.5 the purpose of the psqia is to reduce the number of medical errors6 through voluntary reporting by physicians and other health care providers to patient safety organizations ("psos"). 7 once the error has been submitted to the pso, the information con­ tained in the report will gain, to an extent, an evidentiary privilege, 8 as well as confidential status.9 congress intended that both the privilege and confidential­ ity provisions would serve as an incentive for health care providers to report the medical errors they commit or witness.10 part n of this note assesses the psqia's likelihood of success in reduc­ ing medical errors through the voluntary reporting system. in addition, it also examines whether or not health care providers will actually utilize the voluntary reporting mechanism created by the psqia. statistics published by the joint commission regarding that entity's sentinel event policy shed light on the ex1 see generally patient safety and quality improvement act of2005, pub. l. no. 10941, §§ 921-26, 119 stat. 424 (2005)( codified as amended in scattered sections of 42 u.s.c. ). 2 comm. on quality of healrn care in am., inst. of med., to err is human: building a safer healrn system (linda t. kobn, janet m. corrigan & molla s. donaldson eds., 2000) [hereinafter to err is human]. see also h.r. rep. no. 109-197, at 9 (2005). 3 to err is human, supra note 2, at 26. 4 id. at6. 5 patient safety and quality improvement act §§ 921-26. 6 see h.r. rep. no. 109-197, at 9 (submitted by mr. barton of texas). 7 patient safety and quality improvement act§§ 921(4), 923. 8 id § 922(a). 9 id. § 922(b ). 10 151 cong. rec. s8741, s8741 (2000). 2007] sham peer review 153 tent to which health care providers will utilize the new reporting system. 11 the current use of peer review committees in health care settings, which is becom­ ing increasingly malevolent among providers, is also explored. 12 this part also considers the possibility that the psqia could have an effect exactly opposite of what congress intended. this note concludes by setting forth the proposition that the psqia, much like the health care quality improvement act of 1986 ("hcqia"), 13 will cause a surge in what is called "sham peer review. "14 this result, unfortu­ nately, is in stark contrast to the legislative purposes and intent underlying the psqia. ii. reduction of medical errors as the primary motivation behind the psqia in 1999, the iom issued its report, to err is human: building a safer health system. 15 the report was the result of data gathered from two major studies, the harvard medical practice study and the colorado-utah study.16 each study focused on the rate that medical errors occur in the united states, while also incorporating the recommendations from iom's quality of health care in america committee.17 the harvard medical practice study was com­ posed by randomly selecting more than 30,000 persons who had been dis­ charged from fifty-one randomly selected hospitals in the state ofnew york. 18 similarly, but on a smaller scale, the colorado-utah study looked at a random sample of medical records of 15,000 patient discharges, which were compiled from a sample representing two state hospitals.19 the collective data of these two studies demonstrated the frightening rate at which medical errors have recently occurred in the united states. "when 11 the joint comm'n, sentinel event (2006), http://www.jointcommission.org/nr /rdonlyres/690008c7-eab2-4275-bc7b-68b37481d658/0/se_chap_sept06.pd£ 12 gail garfinkel weiss, is peer review worth saving?, med. econ., feb.l8, 2005, at 46,47 (2005). 13 health care quality improvement act of 1986, pub. l. no. 99-660, 1 00 stat. 3 784 (codified as amended in scattered sections of 42 u.s.c.). 14 weiss, supra note 12 (referring to the semmelweis society). see generally semmel­ weis soc'y int'l, medical peer review with clean hands, www.semmelweis.org (last visited jan. 8, 2007) (the semmelweis society is an organization that helps physician-victinls of sham peer review). see also irifra part iv .b.2 (discussing the semmelweis society in further detail). 15 to err is human, supra note 2. 16 !d. at26. 17 !d. at 5 ( "(the 10m committee] was formed in 1998 to develop a strategy that will result in a threshold improvement in [the] quality [ofhealth care in america] ... "). the 10m report delivered significant data gathered from a 1984 new york study and a 1992 study from colorado and utall. id. at 26. 18 !d. at 30. 19 id. 154 indiana health law review [vol. 4:151 extrapolated to the over 33.6 million admissions to u.s. hospitals in 1997, the results of these two studies imply that at least 44,000 and perhaps as many as 98,000 americans die each year as a result of medical errors."20 even more staggering is that the number of deaths in the united states due to medical er­ rors is greater than the number of deaths attributable to motor vehicle accidents (43,458), breastcancer(42,297), or aids (16,516).21 when analyzing apiece of legislation that aims to correct, or at least minimize, the problem of medical errors, it is important to maintain a real-life frame of reference with regard to what particularly motivated the lawmakers. of particular interest are the errors that arise from mistakes made in the everyday operation of a hospital, as well as mistakes related specifically to prescription medications. a. operations-based medical errors and adverse events in hospitals adverse events and operations-based errors in hospitals can lead to star­ tling results, especially when in hindsight it becomes more clear how easily the error could have been avoided. although not all adverse events stories have tragic endings, the events themselves are still causes for concern. perhaps it is the failed treatment routines and standard operating procedures practiced by hospitals that the health care industry should learn from when reflecting on ad­ verse events. consider, for example, the real-life story of a fourteen-year-old boy who arrives at the emergency department of a rural hospital.22 he presents with symptoms consistent with an overdose of an antidepressant, including a highly irregular heart rate that is threatening to cease at any moment. 23 the physicians need to get the patient to the pediatric intensive care unit of the nearest regional hospital immediately, but it is ten miles away. 24 the attending physician orders an ambulance but does not specify the ambulance type.25 the ambulance ar­ rives and the trip begins through rush hour traffic. 26 soon the physician recog­ nizes the need to hook the patient up to a heart monitor to detect deteriorating function in order to respond with medication or a defibrillator to shock the pa­ tient's heart back into its intended rhythm should such a need arise. 27 the phy­ sician looks around the ambulance only to realize that there is no heart monitor 20 id at26. 2t id. 22 robert m. wachter & ka veh g. shojania, internal bleeding: the truth behind america's terrifying epidemic of medical mistakes 14-17 (2004) (describing a medical­ mistake event that took place in the mid-1980s). 23 id. at 14. 24 id. at 14-15. 25 id. at 15-16. 26 id. 27 id. at 15. 2007] sham peer review 155 and no defibrillator; the physician failed to order a "priority one ambulance.'.28 the physician assumed that the other hospital personnel responsible for order­ ing the ambulance would have known which type of ambulance to request based on the facts provided concerning the patient's condition, 29 but the nurses and other staff in the emergency department failed to make this assessment. 30 from this story, it is easy to conceive of how such an error can occur based on a simple miscommunication, or complete lack of communication. not a single person in this story acted in a manner that was affirmatively adverse to the patient, yet the patient's safety was still compromised. consider also the mistaken identity real-life story ofjoan morris and jane morrison. 31 joan morris was recovering from embolization, a procedure that was intended to relieve her of a brain aneurysm. 32 jane morrison was lying in bed, getting ready to have her cardiac electrophysiology study, which was going to eliminate the parts of her heart that were causing it to beat dangerously ir­ regularly.33 meanwhile, joan morris was scheduled to be discharged that morning to go home, recover, and prepare for her next embolization proce­ dure. 34 instead, the hospital system, which often identifies patients by his or her last name, placed joan morris in the electrophysiology study lab while jane morrison remained lying in her hospital bed with her heart continuing to func­ tion irregularly.35 due to the error caused by the surname mix-up, joan morris received a cardiac procedure that she did not need, and jane morrison missed the very same procedure that she did need to correct her irregularly beating heart. 36 again, here is an example of a medical error caused by miscommunica­ tion, but this time the error is one that stemmed from a cursorily-formed pa­ tient-identifying hospital operating procedure. b. medication-related e"ors medication-related errors, which affect a substantial number of people and are responsible for large increases in health care costs, are one of the most common types of errors. 37 for example, in a study of 101,022 medication or­ ders from two hospitals for children, 479 fallible medication orders were un28 /d. at 15-16. 29 id. at 17. 3o id. 31 id. at 29-41. 32 id. at29. 33 /d. at30. 34 id at 29-30. 35 id. at 33-34. 36 id at 34, 38, 40. 37 e.g., to err is human, supra note 2, at 28. the harvard medical practice study found that drug complications were the most common type of adverse event, occurring nineteen percent of the time. id. at 30. 156 indiana health law review [vol. 4:151 covered and twenty-seven of them were potentially lethal errors.38 the occur­ rence rate of this type of error has increased over the years. 39 in a review of u.s. death certificates between 1983 and 1993, it was found that 7,391 people died in 1993 from medication errors (accidental poi­ soning by drugs, medicaments, and biologicals that resulted from acknowl­ edged errors by patients or medical personnel), compared with 2,876 people in 1983, representing a 2.57-fold increase.40 these statistics demonstrate the severity of the consequences stemming from medication-related errors and colorfully illustrate the rising trend in their occurrence. congress repeatedly cited reports regarding the rate of medical errors that occur in the united states, such as those discussed above, viewing them as the driving force behind the psqia.41 it seems that congress's general thought process with the psqia was as follows: if the fear of malpractice litigation, which is so frequently harbored by health care providers, can be curbed by new reporting protection laws, providers will be more inclined to report adverse medical errors to data collection organizations. such organizations will then analyze, review, and provide feedback concerning the reported medical errors, and eventually the rates of death due to medical mistakes will be lowered. hence, the birth of the psqia.42 ill. the patient safety and quali1y improvement act of 2005 a. background the patient safety and quality improvement act of2005 was signed into law by president george w. bush on july 29, 2005.43 preliminary versions of what ultimately became the psqia, however, had been circulating in congress for an extended period of time and featured elements that were notably different from the final bill. the first of many congressional hearings on the psqia took place in late 1999 and early 2000.44 these hearings established the general pur­ pose of the psqia, which is to encourage medical error reporting, while pro38 id at33. 39 /d. at 32. 40 /d. 41 medical mistakes: joint hearings before the subcomm. on labor, health and human services, and education, and related agencies of the s. comm. on appropriations, the s. comm. on health, education, labor, and pensions, and the s. comm. on veterans' affairs, 106th cong. 1, 55, 99, (2001) [hereinafter hearings 1999-2000]. see generally to err is human, supra note 2. 42 patient safety and errors reduction act, s. 2738, 106th cong. (2000) (enacted). 43 president signs patient sqfety and quality improvement act of2005, global news wire, july 29, 2005, available at www.lexisnexis.com (click on news & business; click on individual publications; click on global news wire; enter title). 44 hearings 1999-2000, supranote41, at 1, 5, 61, 99. 2007) sham peer review 157 vi ding some element of peer review protection. 45 an array of testimonials were heard during the course of these hearings, including discussions of general types of medical errors, patient experiences with medical errors, and recom­ mendations for policy responses, including the importance of making sure that "health care providers can have an opportunity to provide high-quality health care that they were trained to provide in a safe and an effective environment.'.46 b. initial public perceptions the medical industry and others who were interested in reducing the rate of medical errors applauded the signing ofthe bill into law.47 president george w. bush stated, on the day he signed the bill into law, that the "bill is a critical step toward our goal of ensuring top-quality, patient-driven health care for all americans. ,,48 the president further described how the psqia aimed to reduce medical errors through improving the channels of communication among pro­ viders: the patient safety and quality improvement act will help ensure that americans continue to benefit from the greatest medical system in the world. to maintain the highest standards of care, doctors and nurses must be able to exchange information about problems and solu­ tions. yet in recent years, many doctors have grown afraid to discuss their practices because they worry that the information they provide will be used against them in a lawsuit.49 other commentary from various news sources, made in immediate reac­ tion to the bill signing, showed enthusiastic support for the psqia that may have been somewhat overly optimistic as to the psqia' s capabilities and func­ tion. 50 one article addressed the psqia by stating: 45 h.r. rep. no. 109-197, at 9 (2005). 46 hearings 1999-2000, supra note 41, at 5. 47 see new patient safety act shields those who report medical errors, 5 fdanews drug daily bulletin, at 16 (2005), available at www.lexisnexis.com (click on news & busi­ ness; click on individual publications; click on fdanews drug daily bulletin; enter title); tony f ong, protection for reporting: law creating databases smiffs fear of litigation, 35 modern healrncare 12, 12 (2005). 48 president signs patient safety and quality improvement act of 2005, supra note 43 (statement of president george w. bush). 49 ld. 50 see, e.g., new patient safety act shields those who report medical errors, supra note 47; fong, supra note 47. . 158 indiana heal'ih law review the patient safety and quality improvement act . . . creates a national database for nonidentifiable patient­ safety data. the information would be used to develop steps to avoid medical errors. under the legislation, the confidentiality of information reported to patient-safety organizations approved by [the department of health and human services] ... would be guaranteed. the law also shields providers from litigation if they report medi­ cal errors as part of the effort to build the database. 51 [vol. 4:151 while it is true that the psqia provides certain protection in the way of both confidentiality and privilege provisions, it does not shield a provider from litigation. 52 there is nothing in the psqia that prevents victims of medical errors from bringing an action against the responsible provider. c. the functional purpose of the psqia testimony taken during congressional hearings on the psqia identified the different needs for the psqia, ranging from the need to reduce medical errors53 to the need to develop information sharing systems. 54 for example, the final house of representatives' report on the psqia stated, "[the] bill is in­ tended to encourage the reporting and analysis of medical errors and health care systems by providing peer review protection of information reported to patient safety organizations for the purposes of quality improvement and patient safety."55 house reports also show that the psqia is intended to offer provid­ ers some assurance that they are able to discuss their medical errors in an effort to learn from them, and in tum reduce their occurrence without immediately exposing themselves to liability. 56 d. congressional debates concerning the psqia the final reports from the senate and the house reveal congress's intent regarding the enactment of the psqia. one account from representative 51 fong, supra note 47. 52 patient safety and quality improvement act of2005, pub. l. no. 109-41, § 922, 119 stat. 424, 427 (codified as amended in scattered sections of 42 u.s.c.). 53 see supra part ll. 54 for example, the committee on energy and commerce pointed out that while "(i]n its 1999 report, to err is human, the institute of medicine ... estimated that 44,000 to 98,000 americans die each year as a result of medical errors; however, providers have little to no incen­ tive to report or analyze errors to improve the quality ofhealth care." h.r. rep. no. 109-197, at 9 (2005). 55 /d. 56 /d. 2007] sham peer review 159 brown of ohio states the following: the reality is that the consequences of reporting medical errors can be onerous, which deters sqme who commit or witness medical errors from documenting them. this legislation is intended to overcome that obsta­ cle. to reduce the number of medical errors, we need to understand what causes them and address those causes. accurate and complete information on medical errors is the first step. 57 in a more direct assessment of congress's intent behind the psqia, a house representative stated that the psqia establishes a framework for pro­ viders to report their medical errors to patient safety organizations on a volun­ tary basis. 58 the psos will then "analyze the data and recommend steps providers could take to prevent such errors from occurring in the future.',s9 par­ ticularly, the work done by the psos will be incredibly valuable in "identifying national trends on medical errors and recommending how to prevent them. "60 most importantly, the psqia was thought to be a tool which encourages infor­ mation sharing with regard to medical errors by keeping the information that the health care provider shares with the pso from being used against him or her. "the bill would preclude this information, termed patient safety work product, from being used against providers in civil and administrative proceed­ ings, disclosed pursuant to freedom of information act requests, or used to carry out adverse personnel actions.'o61 it is important to take notice, however, that congress did not intend for the legislation to serve as a limit to providers' medical malpractice liability.62 specifically, with regard to the privilege and confidentiality provisions of the psqia, "it is not the intent of this legislation to establish a legal shield for in­ formation that is already currently collected or maintained separate from the new patient safety process, such as a patient's medical record.'o63 in other words, if information is already available to a patient or a patient's attorney, the tion). 57 151 cong. rec. h6673, h6677 (2005) (statement of mr. brown of ohio). 58 /d. at h6676 (statement of mr. bilirakis offlorida) (original sponsor of the legisla59 jd (statement of mr. bilirakis of florida). 60 jd (statement of mr. bilirakis of florida). 61 jd. (statement of mr. bilirakis offlorida). 62 cf id ( "[p8qia] strikes an appropriate balance between encouraging the reporting of valuable information, which will be used to save lives, and safeguarding the ability of indi­ viduals to access necessary information to seek judicial redress when appropriate.") (statement ofmr. bilirakis of florida). 63 151 cong. r.ec. 88741, 88741 (2005) (statement ofmr. enzi ofwyoming) .. 160 indiana healm law review [vol. 4:151 psqia will not protect such information.64 rather, the psqia merely "cre­ ate[ d] a new zone of protection to assure that the assembly, deliberation, analy­ sis, and reporting by providers to patient safety organizations or what we are calling 'patient safety work product' will be treated as confidential and will be legally privileged."65 the privilege created by the psqia is important because, it is extremely unlikely that, without this protection, providers would partake in voluntarily reporting their own medical errors. 66 e. the main "players" of the psqia the persons and entities that are affected by the psqia consist of pa­ tients, health care providers, and psos. while the psqia does not provide a specific definition for the word "patient," for the purposes of this note, ''pa­ tient" will be defined as a person who has obtained medical attention from a health care provider. the psqia does, however, provide explicit definitions for the other two types of players it affects.67 according to the psqia, a "provider'' is "an individual or entity licensed or otherwise authorized under state law to provide health care services. "68 these entities include institutional providers such as hospitals and nursing homes, as well as individual providers such as physicians and nurses. 69 the providers, both institutional and individual, are the players of the psqia that will utilize the voluntary reporting mechanism which is made operational by psos. further, the psqia defines a "patient safety organization" (pso) as "a private or public entity or component thereof that is listed by the secretary pur­ suant to [the psqia]."70 currently, the regulations pertaining to the psqia have not yet been promulgated; however, the psqia sets forth very specific criteria for pso certification,71 with which the future regulations will comply. in order to be a certified pso, the psqia requires, among several crite­ ria, 72 that "[t]he mission and primary activity of the entity are to conduct activi­ ties that are to improve patient safety and the quality ofhealth care delivery.'m additionally, the pso seeking certification will be expected to engage in such activities as the ''utilization of patient safety work product for the purpose of 64 id 65 /d. (statement of mr. enzi ofwyoming). 66 /d. 67 patient safety and quality improvement act of2005, pub. l. no. 109-41, § 921, 119 stat. 424, 425 (codified as amended in scattered sections of 42 u.s.c.). 68 /d. § 921(8)(a). 69 id § 921(8)(a)(i)-(ii). 70 id § 921(4). 71 /d. § 924(a)-(b). 72 id § 924(b)(l)(a)-(g). 73 /d § 924(b)(l)(a). 2007) sham peer review 161 providing direct feedback and assistance to providers to effectively minimize patient risk,''74 and the collection of"patient safety work product from provid­ ers in a standardized manner that permits valid comparisons of similar cases among similar providers. "75 additionally, the organization cannot be an insur­ ance provider; nor can it have any conflicts of interest in carrying out its activi­ ties as a patient safety organization.76 finally, if the pso is related to another entity that provides services apart from those provided by a pso, the patient safety section of the entity must remain separate from the rest of the entity and must not allow any of the information it obtains in its capacity as a pso to be circulated to the other branches of the entity. 77 f. the reporting system the voluntary reporting system created by the psqia is intended to create an incentive for health care providers to report medical errots to the pso with which the providers contract. in theory, the voluntary nature of the reporting system installs safeguards to ensure providers will not be harmed by litigation as a result of reporting errors. only certain data will gain the privilege that is established by the psqia. this data is termed "patient safety work product" and defined by the psqia to include: [a ]ny data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements­ (i)which-{1) are assembled or developed by a provider for reporting to a patient safety organization and are re­ ported to a patient safety organization; or (ii) are devel­ oped by a patient safety organization for the conduct of patient safety activities; and which could result in im­ proved patient safety, health care quality, or health care outcomes; or (ii) identify or constitute the deliberations or analysis of, or identify the fact of trting pursuant to, a patient safety evaluation system. 7 the data described above does not include "a patient's medical record, billing and discharge information, or any other original patient or provider re­ cord."79 in addition, it does not include "information that is collected, main­ tained, or developed separately, or exists separately, from a patient safety 74 jd § 924(b)(i)(g). 75 ld § 924(b)(i)(f). 76 ld § 924(b)(2)(c) 77 ld § 924(b)(2)(a)-(c). 78 ld. § 921(7)(a)(i)-(ii). 79 ld § 921(7)(b)(i). 162 indiana heal til law review [vol. 4:151 evaluation system."80 only information that is created for the explicit purpose of being reported to a pso will be deemed patient safety work product. 81 1. privilege provision the psqia includes a provision that grants an evidentiary privilege to pa­ tient safety work product. 82 this privilege does not apply, however, to patient safety work product "merely by reason of its inclusion in reported patient safety data. "83 only the data that qualifies as patient safety work product under the psqia will gain the privilege.84 patient safety work product enjoys a generous evidentiary privilege mak­ ing it exempt from disclosure in the following proceedings and situations: federal, state, or local civil, criminal, or administrative subpoena or order, including in a federal, state, or local civil or administrative disciplinary proceeding against a provider; . . . discovery in connection with a federal, state, or local civil, criminal, or administrative proceed­ ing, including in a federal, state, or local civil or admin­ istrative disciplinary proceeding against a provider; ... disclosure pursuant to section 552 of title 5, united states code (commonly known as the freedom of in­ formation act) or any other similar federal, state, or lo­ cal law; .... 85 furthermore, patient safety work product will not be admissible evidence in any type of state or federal proceeding, whether it is civil, criminal, adminis­ trative rulemaking or administrative adjudication. 86 such information is also protected from use in professional disciplinary proceedings held by disciplinary bodies formed under state law.87 while patient safety work product does enjoy an evidentiary privilege, such a privilege does not come without limitation. certain rights must be pre80 id § 921(7)(b)(ii). 81 /d. ("such separate information or a copy thereof reported to a patient safety organization shall not by reason of its reporting be considered patient safety work product."). 82 /d § 922(a). 83 h.r. rep. no. 108-31, at 14 (2003). 84 id; patient safety and quality improvement act§ 922(a). the privilege provides that patient safety work product "{will] not be subject to: (1) a civil or administrative subpoena; (2) discovery in connection with a civil or administrative proceeding; (3) disclosure pursuant to a freedom oflnformation act request; or (4) admission as evidence or disclosure in any civil or administrative proceeding." h.r. rep. no. i 08-31, at 14. 85 patient safety and quality improvement act § 922(a)(l )-(3). 86 /d. § 922(a)(4). 87 !d. § 922(a)(5). 2007] sham peer review 163 served in the course of providing a privilege to such data, and as a result con­ gress crafted specific exceptions to the granted privilege. for example, after the court has made an "in camera determination that such patient safety work product contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasona­ bly available from any other source .. .',g8 the data will be excepted from the privilege and will be admissible in court. 89 in addition, other obvious excep­ tions to the rule against disclosure exist, including situations where the health care provider identified in patient safety work product authorizes the disclo­ sure.90 2. confidentiality provision the psqia's confidentiality provision states that patient safety work product "shall be confidential and shall not be disclosed,"91 notwithstanding other federal, state, or locallaw.92 in addition to the exceptions that apply to both the privilege and confidentiality provisions, the psqia further exempts the confidentiality provision from certain disclosures.93 specifically, the confi­ dentiality provision does not prohibit information sharing when such informa­ tion is used for the purpose of carrying out activities relating to patient safety, or if the information is non-identifiable under the psqia.94 the psqia also provides that when the disclosure of information would be allowed under the health insurance portability and accountability act ("hip aa''), such patient safety work product is not protected by the confidentiality provision. 95 the confidentiality provision also will not protect patient safety work product when it is being disclosed by the health care provider to certain entities such as the food and drug administration ("fda") and accrediting bodies that accredit the provider.96 iv. will the patient safety and quality improvement actof 2005 achieve the results congress intended? lawmakers seem to be hopeful that the enactment of the psqia will re­ sult in a reduction in medical errors. lawmakers may have failed to account, however, for the fact that the reporting of the medical errors is still left up to 88 id. § 922(c)(l)(a). 89 id. 90 id. § 922(c)(l)(c). 91 i d. § 922(h ). 92 id. 93 ld. § 922(c)(2). 94 jd. § 922(c)(2)(a)-(b). 95 id. § 922(c)(2)(c). 96 ld. § 922(c)(2)(d)-(e). 164 indiana health law review [vol. 4:151 those who commit them. while peer review committees were established with the best intentions in mind, the attitudes that providers hold of them no longer seem to reflect those beneficent purposes. instead, two new perceptions held by health care providers of peer review committees have emerged: that peer review is underused and misused. 97 a. anticipated underutilization of psos by providers the purpose of the privilege and confidentiality provisions of the psqia is to ensure those providers who report such errors that their disclosure will be studied and analyzed by professionals in order to find ways to reduce future errors. there is reason to believe, however, that even congress • s best inten­ tions may not be enough to deter providers from reporting such errors for fear of losing their jobs or suffering damage to their reputation as a result of the dis­ closure. for instance, one concern that providers share is if they admit to the errors they have committed, they risk being regarded as incompetent by fellow providers.98 additionally, "[p]hysicians and facility employees, primarily nurses, are also concerned about job security and the use of reports in discipli­ nary and adverse employment actions."99 given the well-deserved fears held by physicians and other health care providers, the frequency of utilization of the reporting systems to be developed under the psqia is questionable at best. additionally, a natural phenomenon that is likely to hinder the rate of vol­ untarily reported medical errors is the traditional assumption that health care performance is expected to be largely flawless and purely beneficial. conse­ quently, when errors occur, the natural tendency does not seem to be for the provider who committed the error to report it, and yet such reporting is theoreti­ cally required in order to prevent future errors.100 additionally, many argue that peer review is underutilized as a result of physicians' reluctance to criticize their colleagues.101 when providers discuss their reluctance to report the de­ tails of error events, they cite fear of retribution, ethical dilemmas, and economic pressures. even providers who understand complex system errors and the importance of 97 see weiss, supra note 12, at 48, 51. 98 maxine m. harrington, revisiting medical error: five years after the /om report, have reporting systems made a measurable difference?, is healmmatrix 329, 352-53 (2005). 99 /d. at 354 & n.160 (citing thomas r. mclean, the implications of patient safety research & risk managed care, 26 s. iu.. u. lj. 227, 235-36 (2002)). 100 see palricia r. ebright & katiiryn rap ala, cir. for urban pol'y & env't, a challenge for indiana: medicalerrorrel'ortingsystemcouldboostpatientsafe'iy 4 (2005). 101 e.g., weiss, supra note 12, at 48, 51. 2007] sham peer review learning from them hesitate to report problems because they know that the public often does not understand the complexity of the situation, and this lack of understand­ ing may have legal implications for the provider.102 165 alice g. gosfield, an attorney from philadelphia, says that "[p ]hysicians judging their colleagues are very concerned about the potential impact of peer review, so they'll go through all kinds of contortions to avoid taking action. so, when physicians or administrators move forward, it's usually justifiable."103 in addition to the basic assumption that providers will not voluntarily re­ port their medical errors, medical reporting system statistics also show provid­ ers' reluctance to report adverse events. the most prominent example can be found through the recent use ofthe joint commission sentinel event policy.104 the documented compliance with this policy serves as a useful measurement for the purposes of this note because "sentinel events" are unexpected negative occurrences, such as medication errors, wrong-site surgeries, delay in treatment, and other negligence-related events, 105 which logically suggest that they are likely the result of medical errors. the policy requires the joint commission­ accredited entities to establish within their own policies a definition of"sentinel event" that must be consistent with the joint commission's general defini­ tion.106 based on the accredited entity's definition of"sentinel event," if such an event occurs the entity must follow certain guidelines.107 one action that the entity is encouraged to take is reporting the occurrence of the sentinel event to the joint commission.108 similar to the psqia 's voluntacy scheme, reporting of sentinel events is not required; however, if the joint commission learns of the event, the accredited entity is expected to submit to the root cause analysis and action plan that followed the occurrence.109 the joint commission will then decide if the accredited entity's handling of the sentinel event has met its 102 ebright & rap ala. supra note 100. 103 weiss. supra note 12, at 51. 104 the joint comm'n, supra note ll. los the joint comm'n, sentinel event statistics: as of june 30, 2006 (2006), http://www,jointcommission.orginr/rdonlyres/74540565-4dof-4992-863e8f9e949e6b56/0/se_stats_ 6_30_06.pdf: 106 the joint comm'n, supra note 11, at 1 (''a sentinel event is an unexpected occur­ rence involving death or serious physical or psychological injury. or the risk thereof. serious injury specifically includes loss oflimb or function. the phrase, 'or the risk thereof includes any process variation for which a recurrence would carry a significant chance of a serious ad­ verse outcome."). 107 /d. for example, the entity must engage in a root cause analysis of the event which includes following up with the persons involved to make sure that the process is effective in reducing the likelihood of the same type of event occurring in the future. i d. 108 /d. t09 id. 166 indiana health law review [vol. 4:151 standards. 110 in conjunction with its sentinel event policy, the joint commis­ sion has published statistics relating to sentinel events that shed light on the rate at which providers report their own medical errors. from january of 1995 through december of2004, nearly 3,000 sentinel events throughout the united states were reviewed by the joint commission, meaning that the joint commission was actually notified of the sentinel event.u1 of these 3,000 events, over half were self-reported. thirty-seven per­ cent of the sentinel events that the joint commission reviewed, however, came from the media or other sources, rather than from the accredited entity in which the sentinel event occurred.112 while it is encouraging to see that sixty-three percent of sentinel events were self-reported, the lagging thirty-seven percent is a good indicator that the psqia is not likely to enjoy error reporting participa­ tion from all providers. b. likely development of bad faith or sham peer review 1. a look at state peer review protection statutes that have been used in good faith a familiar trend among health care providers in the u.s. today is the im­ plementation and frequent utilization of peer review committees that are gov­ erned by state peer review protection statutes. many states have in place some form of a peer review protection statute that allows health care providers tore­ port amongst themselves errors and adverse events that take place within their institutions.113 a few legitimate and "good faith" practical uses have come about as a result of peer review protection, as well as a few illegitimate prac­ tices. perhaps the most ideal notion behind peer review protection statutes is to allow a health care institution to learn from its mistakes and as a result make amends with affected partie~. which may in turn curb litigation. for example, if a doctor prescribes a drug to a patient in a slightly higher than recommended yet still tolerable amount, the doctor should have the opportunity to report the error to the hospital's peer review committee. the purpose of reporting would be to allow the peer review committee to investigate the situation, attempt to settle grievances with the patient, and provide education to other health care providers in order to reduce the occurrence of such mistakes in the future. therefore, the doctor should be able to report the error without fear that this information will be used by the hospital or the patient against him. 110 id 111 thejojntcomm'n,supranote 105. nz id. 113 see, e.g., susan 0. scheutzow, state medical peer review: high cost but no bene­ fit-is it time for a change?, 25 am. j.l. &med. 7, 9 (1999). 2007] sham peer review 167 another reason behind peer review protection is the notion that physicians are most familiar with the appropriate standard of care, and they are most capa­ ble of deciding whether one of their colleagues has breached that standard. if, after an appropriate and fairly-conducted peer review process, it is decided that a physician has in fact breached the pertinent standard of care, then it may be proper for the peer review committee to recommend or implement disciplinary action against the physician. however, it is not always the case that peer re­ view processes are conducted fairly, nor that disciplinary action is always war­ ranted or deserved. 2. sham uses of peer review statutes and policies while state peer review protection statutes have created positive results in terms of error reduction and information sharing, it has also had one particu­ larly unfortunate side effect. rather than using peer review committees for ana­ lyzing and attempting to correct adverse events or to discipline health care providers who deserve to be disciplined, a current trend among hospitals is to use the committees as a way to weed out competition. consider, for example, the case of lawrence po liner, a cardiologist from dallas, texas. 114 like many other peer review committees, the committee at the hospital for which he worked has the authority and duty to consider the physician's mistakes and decide which disciplinary action is most appropri­ ate.115 three of his colleagues were found to have "trumped up charges of sub­ standard care against him to eliminate him as a competitor."116 upon this finding, the jury awarded dr. po liner $366 million in damages. 117 another example of a "bad faith" peer review involved a general surgeon named timothy patrick. 118 dr. patrick sued those who initiated a peer review proceeding against him, alleging that the review was "designed to drive him out ofbusiness so competitors could co-opt his practice. "119 it was the jury's award to dr. patrick of$650,000 (which the court trebled) that prompted the push for national legislation to provide "liability protection to physicians who file com­ plaints against colleagues and serve on peer review panels."120 many physicians are beginning to take the view that"[ n ]ot only is the peer review process corrupt, it's ineffective."121 "rather than being used to weed out bad doctors, peer review as it exists today is used primarily as a weapon 114 jeffchu, peer review: doctors who hurt doctors, time, aug. 15,2005, at 52, 52. 115 /d. n 6 id 117 id 118 weiss, supra note 12. 119 /d. 120 /d. (referring to the health care quality improvement act of 1986). 121 id. at48 (quoting ralph m. bard, a physician and attorney in tennessee). 168 indiana health law review [vol. 4:151 against young, vulnerable practitioners."122 in another context, mary h. john­ son, a pediatrician who lost her job subsequent to making a report to a peer re­ view committee regarding a colleague's mismanagement of a newborn's care, stated, "[t]he abuse of peer review for economic reasons or to perpetuate a cover-up is medicine's dirtiest little secret .... "123 consider also the case of dr. thomas wieters, a general surgeon from charleston, south carolina. 124 dr. wieters made a call to the hospital's ceo after finding that one of his elderly patients, who was scheduled for surgery to manage his abdominal aortic aneurysm, had been in the hospital for eleven hours without having any blood work or a cardiogram done.125 after the ceo reached the unit to speak to dr. wieters, dr. wieters politely asked him why his aneurysm patient had been waiting for more than eleven hours with no blood work done and without having received his cardiac medicines. 126 two weeks after this incident, "dr. wieters received a certified letter charging him with 'disruptive behavior. "'127 a general surgery committee that was formed to review the charges against dr. wieters found that they "did not merit disciplinary action, as dr. wieters' admonishments were always directed at failures to provide standard of care. "128 nonetheless, an executive medical committee disagreed, and required dr. wieters to undergo psychiatric evaluation and placed him on a one-year probation.129 while his peer review hearings were ongoing, "dr. wieters con­ tinued to write incident reports detailing examples of negligent care." dr. wieters defended himself, saying, '"[t]hese were my patients, and i would not look the other way' .... "130 soon thereafter dr. wieters was put on summary suspension, a discipli­ nary action supposedly, "reserved for instances when a physician poses an im­ minent danger to a patient or patients."m this type of action, which ''results in the immediate cessation of income in the face of significant legal expenses for self-defense[,]" caused the hospital administrators to notify the national practi­ tioner data bank concerning dr. wieters' status.132 this data bank represents a list of physicians who have been "blacklisted for malpractice, incompetence 122 id 123 /d. 124 william m. johnston, shammed i am, in peer review: due process does not apply for physicians facing sham peer review, gen. surgery news, june 2004, at 1, available at http://www.semmelweis.org/ acrobat/article_ sbamo/o20io/o20am.pdf. 12s id. 126 id 127 id at2. 128 /d. 129 /d. 130 id 131 id 132 id 2007] sham peer review 169 and dependency problems as a threat to the safety of patients."133 the hcqia, 134 from which the national practitioner data bank was born, has been said to be '"a club, a sword that allows hospitals to do whatever they want to do: lie, cheat, embellish, ameliorate, alter records, [and] commit fraud .... "135 ironically, the hcqia, which was intended to achieve many of the same objec­ tives as the psqia, has led to illegitimate disciplinary action against physicians who have done nothing but try to improve the safety and care of their patients. the hcqia was designed and enacted with the intention of allowing open discussion on the matters of medical errors and adverse events, which is the very basis upon which the psqia was formed.136 if the results of the hcqia and medical peer review protection in general are signs of things to come under the psqia, it can reasonably be expected that physicians who prac­ tice medicine with the habit of reporting substandard medical care and correct­ ing medical errors will be forced from their positions on medical staffs at an even higher rate than what is seen today. in response to this argument, proponents of the psqia will cite the provi­ sion that prohibits the use of information reported to the psos in adverse disci­ plinary actions.137 proponents may even cite this section as the cure for the disease of sham peer review; however, the major flaw in such an idealistic ar­ gument is the fact that there is always another way to eliminate the whistle­ blowing employee. in fact, the "bad faith" use of peer review committees has become so widespread that an entire organization, the semmelweis society, has been formed to "help physicians ensnared in what ... [its vice president] calls 'sham peer review. "'138 the semmelweis society is dedicated to helping victimized health care providers, whose plight seems to be a driving factor behind this first group's opinion of peer review.139 a. the semmelweis society and protecting physicians from sham peer review dr. semmelweis, after whom the semmelweis society is named, 140 was a 133 id 134 id see generally health care quality improvement act of 1986, pub. l. no. 99-660, 100 stat. 3784 (codified as amended in scattered sections of42 u.s.c.). 135 johnston, supra note 124, at 2. 136 id. 137 patient safety and quality improvement act of2005, pub. l. no. 109-41, § 922( a), 119 stat. 424, 427 (codified as amended in scattered sections of 42 u.s.c.). 138 weiss, supra note 12, at 48 (referring to the semmelweis society). see generally semmelweis soc'y int'l, supra note 14. 139 see generally semmelweis soc'y int'1, about semmelweis, http://www.semmelweis.org /about.htm (last visited feb. 19, 2007). 140 johnston, supra note 124, at 3. 170 indiana healrn law review [vol. 4:151 "19th-century hungarian-born physician who crusaded for sterile conditions at the vienna general hospital."141 of the two obstetric clinics in the hospital, the one in which dr. semmelweis worked, had a thirteen percent maternal and in­ fant mortality rate, while the other clinic's mortality rate was only two per­ cent.142 like many of the other physicians who worked in his clinic, dr. semmelweis frequently went back and forth between working with cadavers and delivering babies in the obstetrics clinic. 143 upon realizing that the mortal­ ity rate in his clinic was due to physicians carrying infection on their hands from the autopsy room to women in labor, dr. semmelweis pushed for the regular ''practice of hand washing with a solution of chlorinated lime between autopsy work and the examination ofpatients."144 soon after the mortality rate in dr. semmelweis' clinic dropped to two percent, his superior, who had always objected to dr. semmelweis' demand for sterile conditions, refused to reappoint him to the faculty.145 hence, the guiding principle of the semmelweis society, ''peer review should always be done 'with clean hands. "'146 medical peer review committees are currently being used in some cases to weed out health care providers who make a habit of whistle blowing. when new physicians are told, first, to do no harm, surely they do not expect to be bullied into doing exactly the opposite. as dr. semmelweis' case has shown, staying in business as a doctor may require dismissing one's better instincts and allowing medical errors to be forgotten immediately after they occur. consider again the example of dr. wieters who was eventually fired for "disruptive behavior!'147 in actuality, dr. wieters had merely been writing in­ cident reports that reflected his colleagues' substandard care.148 it can hardly be doubted that, in the face of providers who insist on complying with the ob­ jectives of the psqia, hospital administrators will act in the same malevolent fashion as those who held dr. wieters' fate in their hands. little imagination, and even less motivation, is required to craft a justifiable reason for excusing a health care provider who, through his or her reporting conduct, threatens to tar­ nish the reputation of the organization for which he or she works. members of congress are hopeful that those who believe peer review is being misused will fmd comfort in the psqia's provisions that protect the in­ fonnation used in medical error reports from being used as grounds for adverse employment actions. 149 although congress clearly intends for such protection 141 id 142 id 143 /d. 144 id at4. 145 /d. 146 id 147 /d. at2. 148 /d. 149 h.r. rep. no. 108·31, at 14 (2003). 2007] sham peer review 171 from adverse employment actions to be effective in practice, it is highly likely that it will perpetuate adverse employment action, instead of diminish it. after all, it was not until after the health care quality improvement act of 1986 that the medical peer review process took its downhill turn toward abuse and mis­ use.iso v. conclusion it has been said that "no good deed goes unpunished."151 perhaps physi­ cian-victims of sham peer review can identify with this expression. arguably, this is the very type of peer review that will be provoked by a national move­ ment toward voluntarily reporting medical errors through the psqia. the success ofthe psqia relies on those health care providers who will voluntarily come forward with information of medical errors that they have committed or that they have witnessed. only then will the psos, certified un­ derthe psqia, have enough information to analyze and distribute meaningful data that will educate health care providers about the dangerous trends that re­ sult in such errors. unfortunately, these same providers, the ones who have been willing to voluntarily report the grave medical errors committed by them­ selves and their colleagues, are the providers who have been persecuted and driven off of their respective medical staffs for doing just that. this occurrence is likely due to the fear held by medical staffs and hospitals that reported infor­ mation will get into the wrong hands and will be used to the detriment of the provider or the health care organization. from the general public's standpoint, the provider who will strive for safer techniques, who will report the substandard care being provided by her colleagues, and who strives to rectify the wrongs that she herself has caused, is held in very high esteem. for she is the kind of provider we would like to see more of in our hospitals; she is the kind of provider whose good intentions will lead to the success of the psqia. from the hospital's point of view, however, the very same doctor is seen in a dramatically different light. to the hospital system, which is aiming to maintain its good reputation among the public, she is the kind of provider who threatens to raise the cost of care by demanding those more costly, yet safer techniques, and who threatens to draw adverse at­ tention to the hospital. with the practice of sham peer review already at work in the u.s. today, the forecast for the utilization of the process created by the psqia is rather dim. the nasty side-effect oflegislation that encourages health care providers iso johnston, supra note 124. tsl see, e.g., wikipedia, clare boothe luce, http://en.wikipedia.org/wiki/clare_ boothe_ luce qast visited feb. 19, 2007) (stating that luce, a twentieth-century editor, social activist, playwright, journalist, diplomat, and politician, was known for this oft-quoted apho­ rism). 172 indiana health law review [vol. 4:151 to report their errors is likely to be widespread illegitimate disciplinary action taken against the very physicians and nurses upon which the success of the psqia relies. because this very result has already been seen in cases as early as dr. semmelweis' and as recent as dr. wieters', it is highly unlikely that health care providers will report medical errors at a high enough rate to accu­ mulate data that will lead to a truly meaningful analysis and reduction in medi­ cal errors. thus, the grim conclusion of this note: the psqia may initially spur an increased rate of medical error reporting, which, it is feared, will likely spawn an increased rate of sham peer review processes and in turn will be fol­ lowed by an extreme decrease in the rate of error reporting. all in all, it is highly likely that the psqia will have an effect contrary to that which congress intended. taking roll: an assessment of state and local governance of school wellness policies comment sally hubbard* table of contents i. introduction .•.•.•..••.••..••••...••••••.•••••..••••••.••••...•••••.•••••.••••.•....•.•••••••.••. 202 ii. youth obesity and overweight: the gwbal epidemic hrrs home ..................................................................................... 202 a. expanding waste lines on our nation's playgrounds: the alarming reality ............................................................... 203 b. youth obesity and overweight: the social and economic costs ......................................................................................... 204 ill. the preventative role of state government and local school districts: a shift away from omnipotent federal control .................................................. 205 a. theblockcontroversy .............................................................. 205 b. pouring contracts: children gain weight while schools earn pennies on the dollar ........................................ 205 n. nutrition and physical activity: establishing effective policy ......................................................................... 207 a. crafting school health policies: an art and a science ........... 207 b. time, talent, and resources: recognizing the problem is only half the battle ............................................... 208 c. state attempts to resolve the youth obesity crisis: legislative mandate is the key ................................................ 209 v. creating a solution to the crisis of youth obesity and overweight ............... : .......................................................... 211 a. funding is important but real change will necessitate a paradigm shift ...................................................................... 211 b. the cdc's efforts to change national preconceptions about youth obesity and overweight: the social-ecological model .......................................................... 211 c. the cdc wages war on obesity .............................................. 212 vi. conclusion ....................................................................................... 214 * j.d. candidate, 2008, health law concentration, indiana university school oflaw­ indianapolis; m.ed., 2000, university of georgia; b.a, 1999, indiana university. i would like to thank my mom, ann lawrence, for her unconditional love and support. this comment is dedicated to the tbree loves of my life, grant, kierstyn, and hannah hubbard: may you never lose your passion for physical activity. 202 indiana health law review [vol. 5:201 i. introduction during a lecture at the university of south carolina, former u.s. surgeon general richard carmona stated, "obesity is the terror within. unless we do something about it, the magnitude of the dilemma will dwarf9/11 or any other terrorist attempt. "1 dr. carmona added that childhood obesity impacts not only children's personal health, but also society as a whole. indeed,"[w]here will our policemen and firemen come from if the youngsters today are on a trajec­ tory that says they will be obese, laden with cardiovascular disease, increased cancers and a host of other diseases when they reach adulthood?"2 ·carmona's provocative words-analogizing obesity to terrorism-elicit wide-ranging, often emotional, responses. some contingents argued that per­ sonal behavioral choices should not be legislated, while other groups lobbied hard for tougher more uniform state laws requiring schools to intervene in america's obesity crisis. 3 consequently, the "emerging patchwork quilt of laws" relating to public schools' duty to serve as parent, counselor, and food police is a hodgepodge.4 as a result, states are left with little guidance and mi­ nimal incentive to create and enforce effective school nutrition and physical activity policies. 5 this comment will explore how local school wellness poli­ cies are both determined and affected by the expanding regulatory practices of state governments and the rapidly shifting political climates in which they exist. it will also explore various solutions suggested by: ( 1) current scientific literature; (2) applicable social-ecological models; and (3) the potential for state and local governments to strengthen their legislative influence in the public school arena by promoting the dissemination of physical activity initiatives, public health interventions, and strategies designed to improve the evidence-base for theoretically sound wellness policies and programs. ii. youth obesity and overweight: the global epidemic hits home in recent years, the one-two punch of skyrocketing youth obesity and overweight, and the increased incidence of the weight-related medical condi­ tions that accompany them, have been keenly felt in the united states. 6 1. katrina a. jackson, surgeon general: obesity 'terror within,' boston globe, mar. 1, 2006, available at http://www.boston.comfyourlife/healtb/diseases/articles/2006/03/0l/ surgeon _general_ obesity_ terror_ within/(last visited feb. 10, 2008). 2. /d. 3. see generally michele simon & ellen j. fried. state laws on school vending: the need for a public health approach, 62 food & drug lj. 139, 139 (2007) (discussing varia­ tions in state wellness legislative activity). 4. /d. at 139. 5. see generally id. 6. see jeffrey levi et al., f as in fat: how obesity policies are failing in america, issue rep. (trust for am. health, washington, d.c.), aug. 2007, at 3-4, available at 2008] governanceofschoolvvellnesspoucffis 203 a. expanding waste lines on our nation's playgrounds: the alarming reality in the united states, the problem of youth obesity and overweight is cur~ rently so profound that it might rightly be regarded as a plague on america's present and future citizenry. 7 in 2007, for example, the nonpartisan organiza­ tion, trust for america's health, reported that, in 2006, obesity rates rose in thirty-one u.s. states, 8 but indicated that no states decreased their obesity rates during that year. medically, this report is alarming, because youth obesity in­ creases children's risk of developing type-two-diabetes, increased cholesterol, hypertension, and sleep apnea. 9 similarly, youth overweight may lead to ortho­ pedic problems and prematuremenarche.10 the report is also alarming from a sociological standpoint, however, because childhood obesity and overweight, at any stage of development, may also negatively impact children's mental health and school performance. 11 these negative impacts are problematic, not only because they suggest that the obesity epidemic effectively spans the childhood and adolescent continuum, but also because it suggests a trend toward increased socio-educational pressures and health care costs generally, a trend likely to affect all americans on a basic economic level. given the considerations discussed above, it is clear that youth overweight and obesity can dramatically influence not only children's personal, interper­ sonal, and educational development, but also national economics. this revela­ tion suggests that youth obesity and overweight should be considered, as indicated by u.s. surgeon general richard carmona, a dire threat to the na­ tion's future. 12 to confront this threat, however, it must first be made recog­ nizable; thus, a standardized definition for youth obesity and overweight should be determined. unfortunately, youth overweight and obesity-terms frequently tossed around by the media-are not easily definable. for adults, obesity is defined as "an excessively high amount of body fat or adipose tissue in relation to lean body mass."13 as such, adult overweight refers to increased body weight in relation to height, as defined by the body mass index ("bmi"), which uses height and weight in a specialized formula to come up with a single ratio of weight-to-height. 14 in children, however, a modified bmi scale must be used, http://healthyamericans.org/reports/obesity2007/0besity2007report. pdf. 7. !d. at3. 8. !d. 9. mayo clinic staff, cmldhood obesity: compucations (2006), http://www.mayo clinic.comlhealth/childhood-obesity/ds00698/dsection=6 (last visited feb. 10, 2008). lo. id. 11. see jeffrey levi et al., f as in fat: how obesity poucies are f aiung in america, issue rep. (trust for am. health, washington, d.c.), aug. 2006, at 12, 20, http://healthyameri cans.orglreports/obesity2006/0besity2006report.pd£ 12. jackson, supra note 1. 13. levi et al., supra note 11, at 12. 14. body-mass-index (bmi) uses height and weight in a specialized formula to come up with a single ratio of weight-to-height. see id. 204 indiana health law review [vol. 5:201 which takes into account normal differences in body fat between boys and girls at different ages.15 utilizing this modified scale, a youth may be considered overweight or obese if, taking into account height, age, and gender, he or she exhibits a bmi that is abnormally high, as compared to other children in his or her age group. 16 b. youth obesity and overweight: the social and economic costs utilizing the bmi measurement approach outlined above, to define youth obesity and overweight, the center for disease control ("cdc") has deter­ mined that"[ s ]ince 1976, the percentage of overweight children aged 6 to 1 [in the united states] has nearly tripled and the percentage of overweight adoles­ cents ages 12 to 19 more than tripled. 17 as a result, it is clear that obesity is not just an individual problem: annual hospital costs related to treating childhood obesity from 1979 to 1981 were thirty-five million dollars (calculated in 2001 dollars), a dollar amount that increased to one hundred and twenty-seven mil­ lion between the years 1997 and 1999.18 clearly, youth overweight and obesity-related expenses will affect current and future generations of american citizens. these expenses, however, will not be confined to the treatment of children. indeed, studies show that obese chil­ dren are likely to become obese adults. 19 the social costs of this transforma­ tion-loss of future wages and a reduction in our natural resource base-­ combined with the social opprobrium and the increased healthcare expenses associated with obesity, necessitate and reflect the urgency of a deeper explora­ tion of states' roles in addressing public health crises through public schools. this position is supported by a recent position statement issued by the ameri­ can heart association. in pertinent part, that statement concluded that public schools "could become the central element in a community system that ensures that students participate in enough physical activity to develop healthy life­ styles."20 15. see id. 16. see id. 17. balance: a report on state action to promote nutrition, increase physical activity and prevent obesity, mid-year overview (robert wood johnson found., princeton, n.j.), july 2006, at 4, available at http://rwj£orglpdf7balance072006 (last visited feb. 10, 2008). 18. u.s. dept. of realm & human services, preventing chronic diseases: investing wisely in healtii and preventing obesity and chronic diseases through good nutrition and physical activity 1 (2005), available at http://www.healthierus.gov/ steps/summit/prevportfolio/p a-hhs.pdf. 19. am. heart ass'n, fit kids act, http://www.americanheart.org/presenter.jhtml?id entifier-3010851 (last visited feb. 10, 2008). 20. russell r. pate et al., promoting physical activity in children andy outh: a leader­ ship role for &hools, 114 circulation 1214, 1215 (2006), available at http://circ.ahajournals.orglcgi/reprint/114/11/1214?maxtoshow=&hits= 1 o&hits=1 o&resul t format--&fulltext=russell+r. +pate&searchid=1&firstindex=o&resourcetype=hwcit. 2008] lll. the preventative role of state government and local school districi's: a shift away from omnipotent federal control a. the block controversy 205 state government and local school districts play increasingly important roles in regulating school vending and physical activity laws. the shift from omnipotent federal control of school nutrition and physical activity to state and local control began in 1983, with the seminal u.s. court of appeals case na­ tional soft drink ass 'n v. block. 21 in block, the national soft drink associa­ tion (now the american beverage association) sued the secretary of agriculture, who had prohibited the sale of soft drinks, in schools federally funded by the child nutrition act of 1966, until the last meal service of the school day.22 the block court held that the secretary of agriculture went beyond the scope ofhis rulemaking authority when he promulgated "time and place regula­ tions" barring the sale of competitive foods throughout the school until after the end of the last meal service of the day.23 as a result, the child nutrition act of 1966 was amended to reflect the court's decision, and sugary soft drinks-in addition to other foods of minimal nutritional value ("fmnv"), such as snack foods and fast foods-were allowed in public schools throughout the day.24 the national soft drink association's victory was indeed the secretary of ag­ riculture's loss; federal regulatory efforts were drastically weakened, and state and local governments were left scrambling to pick up the pieces and create their own laws regarding school nutrition and physical activity. 25 b. pouring contracts: children gain weight while schools earn pennies on the dollar after the block decision, beverage companies quickly swooped in seeking to establish exclusive ''pouring rights" contracts with public school corpora­ tions.26 not surprisingly, children's soft drink consumption more than doubled 21. seegenerallynatl. softdrinkass'nv. block, 721 f.2d 1348, 1348(d.c. cir.1983). 22. !d. at 1350 (the secretary of agriculture promulgated regulations prohibiting ''the sale of soda water (soda pop), water ices, chewing gum, and certain candies, throughout the public schools ... until after the last lunch meal of the day."). 23. /d. at 1353 ("[t]he secretary exceeded his role making authority when he promul­ gated the time and place regulations barring the sale of competitive foods throughout the school and until after the end of the last service of the day."}. 24. !d. at 1348. 25. seeid. 26. see generally ellen fried & michele simon, the competitive food conundrum: can government regulations improve &hool food?, 56 dukel.j. 1491, 1491 (2007}. 206 indiana health law review [vol. 5:201 in less than twenty-five years.27 by 2004, ''75 percent of high schools, 65 per­ cent of middle schools, and 30 percent of elementary schools had 'pouring rights' contracts. "28 while schools have relied on these beverage contracts to support shrinking budgets, a recent study conducted by the center for science in the public interest ("cspi") and the public health advocacy institute ("phai'')29 lead the robert wood johnson foundation to discount the myth of the beverage company as school financial savior.30 the cspiiphai study, which analyzed 120 contracts in 16 states, concluded that such beverage con­ tracts raised less than $20 per student annually.31 furthermore, it determined that most soft drink revenue generated by in school sales-sixty-seven per­ cent-typically benefits beverage companies.32 in pertinent part, the report states: "this means children (and, by extension, their parents) have to spend one dollar for their school to raise 33 cents.'.j3 the harmful effects of pouring contracts notwithstanding, the effects of the contracts are not completely adverse when effectively mediated by private third parties. for example, the american beverage association, whose mem­ bership includes the cadbury-schweppes, coca-cola, and pepsico corpora­ tions is currently providing healthier drinks such as milk and water to public schools because of an agreement with the alliance for a healthier generation, a collaboration between the william j. clinton presidential foundation and the american heart association. in the agreement, the sale ofhigh calorie drinks in schools will be phased out, and smaller bottle sizes will be introduced. moreover, the alliance and the dairy industry reached an agreement to intro­ duce into schools flavored milks lower in sugar.34 such third party partnerships and alliances may be beneficial in decreasing children's soft drink consumption in schools regardless of the existence of pouring contracts; however, this private regulation may not be enough. participation in such agreements is voluntary for schools, and typically includes long phase-in periods. 35 during these transi27. s.j. nielsen & b.m. popkin, changes in beverage intake between 1977 and 2001, 21 am. j. preventative mel>. 205,207 (2004). 28. fried & simon. supra note 26, at 1494. 29. joy johnson et al., raw deal: school beverage contracts more lucrative than they seem, rep. (ctr for sci. in the pub. interest, washington. d.c.), dec. 2006, at iv, available at http://www.cspinet.orglbeveragecontracts.pd£ 30. robert wood johnson found., study suggests soda pop contracts are mostly bubbles, few bucks (2006), http://www.rwjf.org/programareas/features/feature.jsp? id=21123&typeid=151 [hereinafter soda pop contracts] (last visited feb. 10, 2008). 31. johnson et al., supra note 29, at iv. 32. /d. 33. soda pop contracts, supra note 30. 34. awanceforaiieallhlergeneration,schoolbeverages,http://www.healthier­ genertion.orglcompanies.aspx?id=l376&ekmensel=l ef02451_ 40 _116 _ btnlink (last visited feb. 10, 2008). 35. michelle m. mello et al., the interplay of public health law and industry self­ regulation: the case of sugar-sweetened beverage sales in schools, 91 am. j. pub. health 13 (2007), available at http://www.~ph.org/cgi/doi/1 0.2105/ ajph.2006.l 07680 (last visited feb. 10, 2008). 2008] governance of school wellness policies 207 tional periods, existing beverage contracts which adversely affect the health and wellbeing of america's youth must be followed unless schools are willing to repay hundreds of thousands of dollars to break their beverage contracts. 36 thus, even with effective third party mediation by well intentioned private par­ ties and alliances with special interest groups, whole generations of american school children will continue to suffer the long term detrimental impact of con­ stant exposure to foods with little or no nutritional value. n. nutrition and physical activity: establishing effective policy a. crafting school health policies: an art and a science state and local governments have an essential role to play in crafting school health policy relating, not only to beverage contracts, but also to nutri­ tion and physical activity. the child nutrition and wic reauthorization act of2004 (the "2004 act") required all local school districts participating in the child nutrition act of 1966 to establish a school wellness policy by the begin­ ning of2006.37 this federal law appears to encourage more state and local in­ volvement. for example, the act requires schools to develop local wellness policies; however, under the 2004 act, local school districts retain local discre­ tion in interpreting ''wellness" and in implementing wellness programs. 38 the 2004 act contains no enforcement provisions, but requires schools to maintain certain nutrition guidelines and create health goals relating to nutrition educa­ tion and physical activity.39 state governments, then, have plenary power in designing and implement­ ing school wellness policies. health policies include laws and regulations as well as informal and formal rules and social norms.40 health policies also in­ clude written standards designed to guide the choices of educators and school administrators by helping them to challenge unwritten social norms. for exam­ ple, health policies would allow a school principal to designate additional lunch time for teachers to exercise.41 despite the states' power and interest in protect­ ing the health of their citizens, however, wellness policy is not without fault. for example: [sixteen] states have set nutritional standards on competitive foods [high­ er than those set by the federal government] while 20 states have set time and 36. id. 37. child nutrition and wic reauthorization act of2004, pub. l. no. 108-265, § 204, 118 stat. 729 (2004). 38. child nutrition and wic reauthorization act § 204. 39. child nutrition and wic reauthorization act§ 204. 40. thomas schmid et al., a framework for physical activity policy research, 3 j. physical activity & iiealtii (suppl. 1) s20, s27 {2006). 41. see id. at 822. 208 indiana heal1h law review [vol. 5:201 place restrictions .... [but] only 10 states have rules that apply at all grade lev­ els, and [at] all times ofthe day, throughout the entire school.42 moreover, even that legislation is not necessarily effective, as enforcement of nutritional laws is apparently a low priority in budget-strained schools sub­ ject to increased-testing standards.43 for example: "a 2001 government review revealed that only 15 percent of elementary schools and 13 percent of secon­ dary schools met the nslp [national school lunch program] program re­ quirements for saturated fat.'m such violations are common because, in the words of former assistant secretary of agriculture, carol tucker foremon: [t]he 'usda has very few tools to require compliance' ... if the usda refused to provide federal support to noncompliant school districts, 'the burden would fall not on the school system personnel who've failed to meet the rules but on poor children who depend on school lunch to get enough calories. '45 clearly, the lack of enforcement provisions in the 2004 act hinders the ef­ fectiveness of federal and state policies governing school nutritional guide­ lines. b. time, talent, and resources: recognizing the problem is only half the battle in addition to the challenges posed by attempts to implement nutritionally conscious policies and programs, schools also face another obstacle; overloaded academic schedules that seem to necessitate a decreased emphasis on physical education. with classroom academic time at a premium, state physical educa­ tion requirements are often decreased.46 currently, forty-eight states require physical education in schools, but there are great disparities in the guidelines defining what constitutes sufficient physical education.47 in effect, this means that physical education programs in disparate states rarely require the same amount of physical education, and often impose differing requirements on 42. simon & fried, supra note 3, at 140-41 (discussing variations in state wellness legis­ lative activity). 43. see generally paul d. houston, getting on the right track, sch. governance & leadership, spring 2006, at 6-8, available at http://www.aasa.orglfiles/pdfs/focus/sg&l _spring o/o2006.pdf(last visited feb. 10, 2008). !d. 44. fried & simon, supra note 26, at 1514. 45. id. 46. houston, supra note 43, at 6-8. time spent on physical education and health education is time taken away from academics. federal academic mandates, such as those incorporated into no child left behind ["nclbj, have put the focus squarely on basic academic achievement, and many districts have responded by cutting physical education ... and other non-academic programs .... the government has the big stick ... nclb has come at the expense of .•. physical education. 47. houston, supra note 43, at 6. 2008] governance of school wellness poucies 209 which grade levels receive access to physical education. in response to these disparities: "in 2005, at least 39 states considered legislation related to physical activity or physical education in schools, and at least 21 of those states enacted legislation or passed resolutions" intended to strengthen school physical educa­ tion requirements generally.48 consequently, it is not surprising that a 2000 school health policies and programs study ("shpps,) reported that, "only 6.4% of middle schools provided daily pe [physical education] for the entire school year, whereas 15.5% offered daily pe (or its equivalent) for at least half the school year. "49 in response to the apparent inability of states to reach a con­ sensus on the issue of physical education, an amendment to the no child left behind act was recently proposed at the federal level. 50 the proposed amend­ ment-the fitness integrated with teaching kids act, h.r. 3257-would "re­ quire that all schools, districts and states include the quality and quantity ofpe in the 'report cards • currently sent to parents."'51 the proposed act is backed by the american heart association, and would also fund research for reducing childhood obesity. 52 overloaded academic schedules notwithstanding, states often lack the funding necessary to ensure that physical education initiatives are being ade­ quately executed. 53 moreover, in addition to the lack of funds necessary to in­ crease enforcement of physical activity in public schools, state legislatures also face intense political and lobbying pressures to support the soft drink and snack food industries. specifically, inexperience in negotiating mutually beneficial financial partnerships and the absence of incentives designed to encourage schools and corporations to work collaboratively, combined with a current lack ofwellness policy 'infrastructure .. and a poor understanding of the importance of wellness-driven legislation, all constitute barriers to establishing successful wellness policy at the state and local levels. 54 c. state attempts to resolve the youth obesity crisis: legislative mandate is the key receptivity to wellness legislation is mixed as some states embrace ag· gressive legislation, while others defer to a strong soft drink and snack food industry. in arkansas for example, a 2003 law-act 1220-made arkansas 48. id. 49. pate et al., supra note 20, at 1215. 50. fit kids act, supra note 19. 51. id. 52. id. 53. see generally houston, supra note 43, at 6-8. . 54. see generally fiona' c. bullet al., implementing national population based action on physical activity-challenges for action and opportunities for international collaboration, 13 promotion & educ. 127 (2006), available at bttp://www.minsal.cl/ici/destacados/curso _acti vidad_fisica/bull_final.pdf(last visited feb. 10, 2008). 210 indiana healrn law review [vol. 5:201 the first state .in the country to promote comprehensive measures intended to address childhood and adolescent obesity. 55 act 1220 had three goals: (1) to enhance children's school environment by teaching healthy habits; (2) to en­ gage parents and the community in encouraging children's health; and (3) to enhance the awareness of child and adolescent obesity in order to establish funded support structures. 56 act 1220 mandated that public schools collect in­ formation regarding students' body mass index, information that was later communicated to the students' parents. 57 this mandate, while initially contro­ versial, utilized a well-received comprehensive support system and unique in­ formational technology in aiding the legislature in accomplishing its goals.58 as a result, by 2003, after only one year of implementation, act 1220 was re­ garded as a successful statewide intervention in the· fight against youth obesity and overweight, 59 and by 2005, ninety eight percent of the public schools in arkansas were participating in the bmi assessment regime. 60 conversely, in indiana, the collection of bmi information on public school students was not mandated by law. instead, because it lacked the sup­ port of a legislative mandate, the indiana state department of health and the indiana department ofeducation merely requested that indiana public schools collect height and weight for all enrolled students.61 as participation in the bmi data collection effort was voluntary, the vast majority of indiana's public schools declined to collect height and weight data on their students. 62 clearly, arkansas's successful effort to mandate the collection and dis­ semination of bmi data on students in public schools differed dramatically from the non-mandatory-voluntazy-bmi data collection efforts in the state of indiana. indeed, even a superficial comparison of the two initiatives makes it clear that the variation in political receptivity among legislators dramatically affects the ability of schools to collect consistent, reliable data on child obesity and overweight. 55. child health advisory committee act of2003, ark. ann. code.§ 20-7-133-135 (2003) . . 56. the 2005 arkansas assessment of childhood and adolescent obesity, exbcunve summary (ark. ctr. for health improvement. little rock, ark.) 2005, at 6 [hereinafter the 2005 assessment]. see generally act 1220 summary, ark. center. for hbalm improvement, http://www.achi.net/current_ioitiativesibmi_infoidocs/acf_l220_summary .pdf (last visited feb. 10, 2008). 57. see generally act 1220 summary, supra note 56. 58. see generally id. 59. jamesm. raczynskietal.,establishingabaselinetoevaluateact 1220of2003: an act of the arkansas generally assembly to combat childhood obesity, rep. (coil. pub. hbalm, u. ark. for med. sci., little rock, ark.), 2005, at 10, available at http:// www.uams.edu/coph/reports/2004actl2202003yleval.pdf 60. the 2005 assessment, supra note 56, at 1. 61. terry w. zollinger et al., obesity related data in indiana: a resource guide, rep. (ind. st. dep't. health, ind. univ. school med. dep't. fam. med., indianapolis, ind.), 2007, at 13, available at http://www.in.gov/isdhlprograms/cnop/pdfs/obesityresourceguide.pdf. 62. id. 2008] governance of school wellness policies v. creating a solution to the crisis of youth obesity and overweight a. funding is important but real change will necessitate a paradigm shift 211 creating an effective solution to the youth obesity crisis is critical, costly, and frequently confusing. the trust for america's health chronic disease directors reports: "[e]fforts to combat the obesity crisis will not be successful until there is a real paradigm shift. with a sustained focus on well-funded, long­ term approaches, a revitalized research agenda that emphasizes longitudinal studies, and a fresh look at what constitutes "success" and how it is meas­ ured."63 decreasing funding and political opposition for the development, imple­ mentation, and evaluation oflarge-scale obesity studies are monumental barri­ ers to finding comprehensive solutions. even the cdc-a federal agency­ and its national center for chronic disease prevention and health promotion ("nccdphp"),both charged with the task of promoting health by preventing and controlling disease, have declining budgets for obesity-related programs. 64 in fact, the nccdphp budget is equal to a meager three dollars per person an­ nually in the united states, "which is less than the cost of most fast-food meals."65 b. the cdc's efforts to change national preconceptions about youth obesity and overweight: the social-ecological model funding issues notwithstanding, the cdc does provide a structured framework for state governments seeking to establish comprehensive nutrition and physical activity programs. the cdc currently provides twenty-eight states with funds necessary to address obesity using a variety of cdc approved nutrition and physical activity strategies, including public school interven­ tions. 66 specifically, the cdc funds states which use a social-ecological model to address obesity.67 the social-ecological model addresses youth obesity and 63. levi et al., supra note 11, at 53. 64. /d. 65. /d. 66. ctr. for disease control & prevention, state based programs: cdc's state· based nutrition and physicalactivityprogramto prevent obesity and orner chronic diseases, http://www.cdc.gov/nccdphp/dnpalobesity/state _programs/index.htm (last visited feb. 10, 2008). 67. !d. ("from individual behavior change to changes in public policy, state efforts aim to engage multiple levels of society; this is called the social-ecological model, and it is a cornerstone of our approach."). 212 indiana health law review [vol. 5:201 overweight using a five-tiered protocol designed to instigate change at the so­ cietal, community, organizational, interpersonal, and individuallevels.68 the social-ecological model's first level requires change at the societal level. 69 at the societal level, the cdc advocates individuals, organizations, and communities working together to create nutrition and physical activity legisla­ tion and statewide school policies.70 at the second or community level, the cdc funds states working to improve environmental conditions, through strat­ egies designed to improve such things as recreation facilities or accessibility to inexpensive and abundant produce.71 the social-ecological model's third level involves organizational changes such as increased school sports teams or in­ creased physical activity at a local level, while at the fourth level, interpersonal groups such as families and friends encourage each other in healthful behav­ iors. 72 these fourth level interventions may be especially important in light of a recent study showing that obesity and thinness are "socially contagious" in fam­ ily and friend situations. 73 the final level of the cdc's social-ecological model is the individual level, at which the cdc suggests obesity and other chronic diseases can be addressed by changing individual behaviors. 74 c. the cdc wages war on obesity the cdc's willingness to offer federal monies in support of school-based obesity initiatives has been an essential element in the war on youth obesity and overweight. indeed, the cdc's support has provided essential support to school-based initiatives in several ways. first, the cdc's support has facili­ tated the creation of a "coordinated school health program," which teaches schools and communities how to create healthier school environments through the integration of community and family involvement. 75 second, the cdc's support has lead to the development of a "physical education curriculum analysis tool" which helps school districts evaluate their physical education curriculum based upon national physical education standards. 76 schools can then use the results of this tool to enhance existing curricula or to develop new 68. /d. 69. ctr. for disease control& prevention, overweight and obesity: state based programs: social-ecological model, http://www.cdc.gov/nccdphp/dnpa/obesity/state_pro grams /se_model.htm [hereinafter social-ecological model] (last visited feb. 10, 2008). 70. /d. 71. id. 72. /d. 73. see generally nicholas a. cbristakis & james h. fowler, the spread of obesity in a large social network over 32 years, 357 new eng. j. med. 370-79, (2007). 74. social-ecological model, supra note 69. 75. ctr. for disease control & prevention, see heal1hy you1hi: funded partners: states, territories, and localities: coordinated schoolhealthprograms, http://www.cdc.gov /healthyyouth/partners/funded/cshp.htm (last visited feb. 10, 2008). 76. /d. 2008] 213 programming. 77 finally, the cdc has awarded an average of$416,000 in "di­ vision of adolescent and school health" ("dash'') cooperative agreement funds to twenty-three states in 2006.'8 the u.s. department of education works with dash-state departments of health to create school-based policies and programs addressing youth obesity. 79 states utilizing cdc funding are using creative strategies to address solu­ tion-resistant youth obesity. for example, the colorado physical activity and nutrition program ("cop an'') utilized cdc funding to support rural commu­ nities such as commerce city, where low-income preschool students-a popu­ lation largely understudied-and their parents are offered nutrition, cooking, and literacy programs.80 not all states, however, are using the cdc funding and support as the sole source of creative solutions designed to address youth obesity at the school level. one appetizing boston-based program is funded by the boston public health commission and project bread.81 under that pro­ gram, a top boston restaurant chef is working with school cafeteria managers to teach them how to cook nutritious, flavor-rich, meals such as chicken parmesan pizza and hummus. 82 it is hoped that school cafeteria managers will then re­ place the traditional greasy cafeteria fare ofburgers, fries, french toast sticks, and smoky links with less traditional healthier alternatives. 83 the chef also takes photos of the actual food and hangs them on the school wall, so children will be exposed to the healthy foods in a visual way. 84 indiana, on the other hand, is taking a different approach to educating stu­ dents about good nutrition. indeed, rather than relying on cdc funding and support exclusively, indiana is also using its own high school students to teach younger students the importance of proper nutrition. these students, known as the insight youth corps, are working, under a state based initiative, "to pro­ vide experience-based learning, enhance personal and academic achievement, and build leadership skills among its members, preparing them for future suc­ cess and commitment to lifelong healthy lifestyles and health advocacy.'.ss the insight youth corp is a branch of governor mitch daniels' statewide health initiative, inshape indiana, which provides a one-stop-shop for finding indi­ ana-based physical activity, nutrition, and tobacco prevention and cessation information. 77. id. 78. levi et al., supra note 6, at 35. 79. id. 80. ctr.fordiseasec0ntrol&prev'ention,overweightand0besity,http://www. cdc.gov/nccdphp/dnpa/obesity/state_programs/about_us.htm (last visited feb. 10, 2008). 81. j.m. lawrence, schools hope chefs touch whets cafeteria appetites, boston globe, sept 13, 2007, available at http://www.boston.com!yourlife/bealtb/fitness/articles/ 2007/09/1 0/schools _hope_ chefs_ touch_ whets_ cafeteria_ appetites/ (last visited feb. 10, 2008). 82. id. 83. id. 84. id. 85. state of ind. inshape ind.,insightyoumcorps, http://www.in.gov/insbape/2344 htm (on file with the author). 214 indiana realm law review [vol. 5:201 what public school wellness programming options do states not funded by the cdc have? in 2002, congress asked the institute ofmedicine ("i om") to develop a prevention-focused action plan to decrease youth obesity in the united states. 86 the iom responded by developing interventions for use by the federal, state, and local governments. 87 at the federal level, the iom suggested developing an interdepartmental task force to coordinate federal actions with regard to school wellness programs. 88 it also suggested that the federal gov­ ernment expand funding for prevention intervention research, experimental be­ havioral research, and community-based population research. 89 at the state and local government level, the iom recommended encouraging opportunities for physical activity in the community, through changes in ordinances and capital improvement programs. 90 under these interventions, schools were encouraged to improve the nutritional quality of food and beverages and to implement school-based interventions which would decrease "screen time."91 the iom also recommended that schools conduct annual assessments of students' weight, height, and bmi, in addition to ensuring that all children and youth par­ ticipate in a minimum of thirty minutes of moderate-to-vigorous physical activ­ ity during the school day.92 the iom also designed interventions for media outlets and the food industry generally.93 specifically, the 10m encouraged industrial entities to develop healthier foods, while at the same time working with media outlets to expand consumer awareness of nutritional information.94 to implement successful wellness policy, scientists, lawyers, and legisla­ tors must work together· in understanding current research. an article in the journal of physical activity and health suggested a starting point for policy formation, stating that: "a popular model of policy development ... describes three interrelated factors that are thought to influence the development, imple­ mentation, and outcomes of policy: the knowledge base (research/evidence), social strategy (effective interventions/solutions) and political will."9s vi. conclusion more federal and state funding is needed to increase the research and evi­ dence knowledge-base related to youth obesity and overweight. effective in86. preventing childhood obesity: health in the balance, rep. brief (lnst. ofmed., washington, d.c.), 2004, at 1, available at http://www.iom.edu/object.fi1e/master/25/858 /childhood%200besity%204-pager-fix%20for%20web%20pdt:pdf(last visited feb. 10, 2008). 87. i d. at 2-3. 88. id. at3. 89. id. 90. ld. 91. id. 92. id. 93. id. 94. ld. 95. schmid et al., supra note 40, at s28. 2008] governanceofschoolvve~spoucffis 215 terventions and solutions are imperative, but to be successful, states and practi­ tioners must follow arkansas's bold lead and disseminate intervention on suc­ cessful youth obesityinterventions to others. moreover, the american heart association's scientific statement on promoting physical activity accurately summarizes the role schools must play to ensure that obesity is not allowed to remain, as dr. richard carmona suggested, the terror within: schools are potentially attractive settings in which to promote positive health behaviors because students spend large amounts of time in the school environment, elements of the traditional school curriculum relate directly to health, and schools typically provide extracurricular programs that can promote health ... disquieting trends in other segments of american society, such as in­ creased "screen time" and decreased reliance on physically active transport, indicate that the schools should assume a leadership role in ensuring that young people engage in adequate amounts of physical activity each day. this state­ ment advances policy initiatives that, if fully implemented, would position american schools as societal leaders in addressing an enormous public health challenge. 96 furthermore, as laws regarding the prevention and treatment of youth ob­ esity and overweight can change with each electoral cycle, politicians, at all levels of federal, state, and local government, must be willing to reach the com­ promises necessary to establish stable health policies. finally, governors, legis­ lators, and educators-in addition to families and individual students-must demand adequate funding for further research into the expanding youth obesity problem in america. 96. pate et al., supra note 20, at 1220. h. tristram engelhardt, jr. h. tristram engelhardt, jr., holds an m.d. with honors from tulane university school of medicine (1972) and a ph.d. from the university of texas at austin (1969), where he completed his undergraduate work (1963). he was a fulbright graduate fellow at bonn university, germany for the academic year 1969-70, a fellow at the institute for advanced study in west berlin (germany) in 1988-89, a visiting scholar at the lntemationale akademie fur philosophie im fiirstentum liechtenstein in fal11997, and a visiting scholar at liberty fund, indianapolis, indiana in spring 1998. currently, dr. engelhardt is professor in the department of philosophy, rice university. in addition, he is professor emeritus in the department of medi­ cine, as well as in the department of community medicine, baylor college of medicine. he has held appointments at rice and baylor since january 1983, after leaving georgetown university, where he was the rosemary kennedy professor of philosophy of medicine. dr. engelhardt is editor of the journal of medicine and philosophy, senior editor of christian bioethics, and editor of the philosophy and medicine book series with over eighty volumes in print. he is also editor of the book series plm.osophical studies in contemporary culture. he has authored over 285 articles and chapters of books in addition to over 100 book reviews and other publications. there have been over 135 reprintings or translations of his publications. he has also co-edited more than twenty-five volumes and has lectured widely throughout the world. his books include bioethics and secular humanism: the search for a common morality (trinity press int'l & scm press 1991) and the second, thoroughly-revised edition ofthefoundationsofbioethics (oxford 1996), which has appeared in chinese, italian, japanese, portuguese, and spanish. a chinese translation of bioethics and secular humanism appeared in 1998. his most recent work is the foundations of christian bioethics (swets & zeitlinger 2000). dr. engelhardt may be contacted at the following: department of philosophy, rice university, p.o. box 1892, houston, texas 77251-1892, home phone: (713) 660-7861, home fax: (713) 660-7861, office phone: (713) 348-2491, email: htengelh@rice.edu. giving, seiling, and having taken: confucting views of organ transfer"' h. tristram enge1hardt, jr.** llitroduction:rethuaangthefoundationsof organ transfer poucy this essay does not seek directly to solve the contemporary health care policy challenges regarding the availability of organs for transplantation. 1 instead, the goal is to re-examine the moral and political theoretical founda­ tions of current approaches to the acquisition of organs for transplantation. it steps back from generally accepted policy so as to pose basic questions regarding how organs may be acquired. this undertaking is critical in the sense of exploring what is taken for granted in order better to judge whether current policy ought to be accepted. the prevailing view is that organs may be donated but not sold, despite the shortfall in organs and the consequent loss of life. 2 this essay assesses the prohibition of organ sales in terms of the constraints of a plausible secular moral framework,3 not to defend the moral * an ancestral version of this paper was delivered at grand rounds, department of lntemalmedicine, indiana university school ofmedicine, indianapolis, indiana, november 12, 2003. ** h. tristram engelhardt, jr., ph.d., m.d., is professor, department of philosophy, rice university, houston, texas, and professor emeritus, department of medicine, baylor college of medicine, houston, texas. 1. for the basis of current american public policy concerning organ transplantation, see dbp't of health & human servs., report of the task force on organ transplani'a· tion: issues and recommendations (1986). see also hastings ctr.,ethical, legal, and poucy issues pertaining to soud organ procurement: a report to the project on organ transplani'ation (1985); unesco, human rights aspects of traffic in body partsandhumanfetusbsr>rresearchand/or1'herapeuticpurp0sbs(1989);world health oro., legislative responses to organ transplani'ation (1994); office of tech. assessment, u.s. congress, ota-ba-337 ,new developments in biotechnology: 0wnershipofhumantissuesandcei.ls-specialrbport (1987); comm. on organ pro. curement&transplani'ationpoucy,inst.ofmed.,organprocurementandtrans­ plani'ation: assessing currentpoucies andthepotentialimpactofthe dhhs final rule (1999); james f. childress, some moral connections between organ procurement and organ distribution, 3 j. contbmp. healthl. & pol'y 85 (1987); massachusetts task force on organ transplantation, excerpts from the report of the massachusetts task force on organ transplantation, in humanoroantransplani'ation: societal,medical-legal,regula­ tory, and reimbursement issues 211 (dale h. cowan et al. eds., 1984). for the basis for current federal legal constraints on organ sales, see national organ transplant act § 301, 42 u.s.c. § 274e (2003). 2. mark j. cherry, persons and their bodies, in persons and 1l!eir bodies: righi's, responsffilui1es, relationships 1 (mark j. cherry ed., 1999). 3. the purpose of this paper is not to establish the correct approach to the distribution of organs grounded in a rightly-directed understanding of the human good and of human flourishing, but rather to explore what can be established within the resources of a general 32 indiana health law review [vol. 1:29 goodness or rightness of organ sales, but merely to show why such sales cannot plausibly be prohibited by secular moral authority. a critical assessment of our prevailing cultural commitments and assumptions4 requires asking why many humans die because of the unavail­ ability of organs for transplantation, while at the same time many others die without ever making their organs available for those whose lives could have been prolonged by a donation.5 it begins by recognizing three policy options: (1) encouraging altruism-persons might be induced to think more of the suffering of their fellows and thus make their organs available to those in need not only at death, but even as living donors. the accent here is on the autonomy and altruism of the donors;6 secular moral argument. see, e.g., h. tristra.j.\i engeufardt, jr., the foundations of bioetillcs (2d ed. 1996). 4. there is considerable literature exploring the issue of organ sales. see, e.g., preface to persons and their bodies: rights, responsffillities, relationships (mark j. cherry ed., 1999); g.m. abouna et al., commercialization in human organs: a middle eastern per­ spective, 22 transplantation proc. 918 (1990); a. frank adams, iii et al., markets for organs: the question of supply, 17 contemp. econ. pol'y 147 (1999); nicholas capaldi, a catholic perspective on organ sales, 6 christian bioetmcs 139 (2000); mark j. cherry, body parts and the market place: insights from thomistic philosophy, 6 christianbioetmcs 171 (2000) [hereinafter cherry, body parts]; mark j. cherry, is a market in human organs necessarily exploitative, 14 pub. aff. q. 337 (2000) [hereinafter cherry, exploitative]; paul hughes, exploitation, autonomy, and the case for organ sales, 12 int'lj. appued phil. 89 (1998); leon kass, organs for sale? propriety, property, and the price of progress, 107 pub. int. 65 (1992); p. manga, a commercial market for organs? why not?, 1 bioetmcs 321 (1987); clifton perry, human organs and the open market, 91 ethics 63 (1980); janet radcliffe-richards et al., the case .for allowing kidney sales, 351 lancet 1950 (june 27, 1998); janet radcliffe-richards, nephrarious goings on: kidney sales and moral arguments, 21 j. med. & phil 375 (1996); k.c. reddy et al., unconventional renal transplantation in india, 22 transplantation proc. 910 (1990); d.j. rothman et al., the bellagio taskforce report on transplantation, bodily integrity, and the international traffic in organs, 29 trans­ plant ationproc. 2739 (1997); c.m. thiagarajan et al., the practice of unconventional renal transplantation (ucrt) at a single centre in india, 22 transplantation proc. 912 (1990); danilo c. tiong, human organ transplants, in beyond a western bioetmcs 89 (angeles tan alora & josephine lumitao eds., 2001); larry torcello & stephen wear, the commercialization of human body parts: a reappraisal from a protestant perspective, 6 christian bioetmcs 153 (2000). for a study of many of the background philosophical issues, see office of tech. assessment, u.s. congress, new developments in biotechnology: ownership of human dssues and cells, ota-8a-337 & 0ta-bp-8a-45 (u.s. gov't printing office 1987). 5. from 1995 to 2002, more than 39,600 patients in the united states died waiting for an organ to be available for transplantation. markj. cherry, kidney for sale by owner: human organs, transplantation, and the market (forthcoming 2004). 6. for a classic defense of the importance of the gift relationship over the commercial relationship, see richard m. titmuss, the gifr relationship (1971) (focusing on the acquisition of blood for transfusion). 2004] conflicting views of organ transfer (2) confiscating organs-state force might be used to transfer organs from those who have to those who have not, either at death or perhaps even through an organ draft of non-paired organs.7 state force could be cloth­ ed as a kind of "giving," similar to when the burden of proof is shifted by presumed-consent laws from the acquirer of the organ to the source of the organ, thus putting all persons at jeopardy of having their organs taken as a "gift" if they fail to take effective steps to the contrary.8 under such circumstances, all persons are forced to make a decision or have their organs put at the risk of being taken. the accent in this policy is on state authority and the good of saving lives. (3) paying for organs-the market might be employed to engage the interest of potential providers of organs and/ or their families by offering incentives ranging from covering funeral expenses, paying a death benefit, or giving a credit against estate taxes, to substantial pay­ ments to the families or even to living sellers to encour­ age organ transfer at death or while still alive.9 7. robertnozick, anarchy, state, and utopia 206-07 (1974). 33 8. see, e.g., presumed consent subcomm. of the unos ethics comm., united network for organ sharing, an evaluation of the ethics of presumed consent and a proposal based on required response (1993); jose mainetti et al., bioethics in argentina, in regional perspectives in bioethics 71 (john peppin & mark cherry eds., 1990); g.r. schutt, 25 years of organ donation: european initiatives to increase organ donation, 34 transplantation proc. 2005 (2002); a. spital, mandated choice for organ donation: time to give it a try, 125 annals lnternalmed. 66 (1996); l. roles et al., effect of a presumed consent law on organ retrieval in belgium, 22 transplant ationproc. 2078 (1990). 9. the american medical association's council on ethical and judicial mfairs, for example, recently announced that it would likely be morally permissible for competent adults to enter into a future contract for payment to an individual's family or estate after death, once the organs are retrieved and judged medically suitable for transplant: the voluntary donation of organs in appropriate circumstances is to be encouraged. however, it is not ethical to participate in a procedure to enable a living donor to receive payment, other than for the reimbursement of expenses necessarily incurred in connection with removal, for any of the donor's non­ renewable organs. procedures involving financial incentives for cadaveric organ donors should have adequate safeguards to ensure that the health of donors and recipients is in no way jeopardized, and that the quality of the organ supply is not degraded. incentives should be limited to future contracts offered to prospective donors. by entering into a future contract, an adult would agree while still competent to donate his or her organs after death. in return, the donor's family or estate would receive some financial remuneration after the organs have been retrieved and judged medically suitable for transplantation. several other 34 indiana health law review [vol. 1:29 the question then becomes why public policy should embrace or ex­ clude any one of these three policy options or a combination thereof. a number of background empirical assumptions, as well as very parti­ cular moral and philosophical understandings, support endorsing or condemn­ ing particular combinations of these approaches. there are at least five crucial areas of dispute regarding appropriate approaches to the organ shortage. first, there are conflicting views regarding the moral authority of indivi­ duals. the more humans are regarded as having authority over themselves, including their bodies, the more it will be morally necessary to gain explicit pennission for the transfer of their organs, and the more difficult to justify the use of state coercion in prohibiting peaceable, non-fraudulent sales and transfers of organs. second, there are conflicting views regarding the moral authority of states. depending on the extent to which states are regarded as having an original moral authority over their subjects, such that the state in some sense (or senses) presumptively owns and/or controls citizens and their possessions in the state's sovereign territory, including their organs, it will appear plausible to prohibit peaceable, voluntary transfers and sales of organs. there is a range of views regarding the appropriate moral authority of states over their citizens or subjects, spanning from endorsing outright tyrannies in which the wishes of the few are imposed on the many, to social democratic regimes where the views of a majority are imposed on minorities,10 to limited democratic regimes that protect a considerable space for peaceable interactions, which many, often even the majority, may find to be morally abhorrent 11 conditions would apply: (1) only the potential donor, and not the donor's family or other third party, may be given the option of accepting financial incentives for cadaveric organ donation. in addition. the potential donor must be a competent adult when the decision to donate is made, and the donor must not have committed suicide. (2) any incentive should be of moderate value and should be the lowest amount that can reasonably be expected to encourage organ donation. by designating a state agency to administer the incentive, full control over the level of incentive can be maintained. (3) payment should occur only after the organs have been retrieved and judged medically suitable for transplantation. suitability should continue to be determined in accordance with the procedures of the organ procurement and transplantation network. ( 4) incentives should play no part in the allocation of donated organs among potential transplant recipients. the distribution of organs for transplantation should continue to be governed only by ethically appropriate criteria relating to medical need. codeofmedicalethics,op.e-2.15 (am. med. ass'n 2003). 10. consider the apt characterization by nozick of more than limited governments as committed to an ownership of the people, by the people, for the people. see nozick.supra note 7, at 289-90. 11. at stake is the significant cleft between formal-right constitutions and material-right constitutions, where the former seek to establish procedural mechanisms for the peaceable collaboration of citizens in the absence of a thick. common understanding of justice or fairness, and the latter seek to establish a particular view of the human good and human flourishing through endorsing constitutionally recognized claim rights. 2004] confucting views of organ transfer 35 third, there are conflicting views regarding the moral significance of commodifying12 human body parts. depending on the extent to which market exchanges are regarded as paradigmatic of peaceable mutual respect, the acquisition of organs through sales will appear noble or demeaning. this judgment will be limited by the consideration that some humans hold that the commodification of human body parts involves an intrinsic evil. 13 fourth, there are conflicting views regarding the nature and moral implications of exploitation. depending on the extent to which personal autonomy is regarded as cardinal, or the commodification of organs as evil, there will be different views about who would be exploiting whom, given different policies for organ transfer. for example, those who accent the authority of individuals over themselves may regard presumed consent policies as a form of state exploita­ tion of human vulnerability, since humans often do not plan in advance and thereby effectively fail to record their opposition to having their organs transferred. some regard offering payments to the poor for selling organs to the rich as exploiting the poor, while others hold that the legal prohibition of such sales exploits the poor by paternalistically and coercively imposing the values of the rich on the attempts of the poor peaceably to advantage them­ selves. still others would hold that the healthy poor exploit the rich, sick, and dying by offering to sell them necessary organs at high prices.14 it will be necessary to determine when exploitation is, with justification, morally endorsed or disapproved. after all, one can speak of exploitation in a positive sense, as when one exploits beneficent sentiments on the part of disputing parties in order to bring about a reconciliation. 12. the term "commodify" is often engaged in order to suggest that payments for a particular service or good render the provision of such service or good morally inappropriate. consider, for example, those who would hold that taking money for fornicating renders the act more grievous. for a discussion of some issues bearing on commodification, see consuming health: the commodiflcation of health care (saras henderson & alan r. petersen eds., 2002); margaret jane radin, contested commodities (1996); w.b. amason, directed donation: the relevance of race, hastings center rep., nov. 1991, at 13; eric mack, inalienable rights in the moral and political philosophy of john locke: a reappraisal, in persons and their bodies: rights, responsiblljties, relationships, supra note 2, at 143. 13. one of the philosophical theorists opposing not just the sale of organs but the gift of organs from living donors is immanuel kant, who condemns such transfers in terms of his account of morality, not because those transfers are intrinsically evil, but more fundamentally because they are alleged to have a wrongness independent of any concern regarding benefits and harms. at issue is the existence of a wrong-making condition supposedly independent of concerns with consequences and which cannot be defeated by consent-kant's account of a categorical imperative. immanuel kant, grundlegung zur metaphysik der sitten, ak iv 416 (de gruyter 1968). kant's account of autonomy is thus grounded in his account of moral rationality and is independent of what one might wish or desire to do. id. at ak iv 432-33. this account of morality is grounded in kant's identification of morality with rationality, which lies at the heart of his solution to the seeming conflict between determinism and freedom. immanuel kant, critique of pure reason, a538=b560-a559=b587. 14. cherry, exploitative, supra note 4. 36 indiana health law review [vol. 1:29 finally, there are conflicting views regarding the likely impact of parti­ cular policies. depending on the extent to which altruism prompts donations, sales undercut donations, or the commodification of organs involve untoward moral and/or other consequences, many will invoke the specter or premise of alleged dangers or benefits to favor one policy over others. such empirical concerns are often highly speculative and very difficult to assess objectively. for purposes of this essay, it is assumed that philosophical concerns are more decisive than empirical ones: empirical concerns must be placed in a moral interpretive context before their implications can be determined. i. why should the authority of individuals carry such weight? humans are a morally contentious breed. in the absence of a state­ imposed orthodoxy, humans tend not only to engage in open foundational moral disputes, but also lack the intellectual resources to resolve their moral controversies by sound rational argument. in bioethics, there is both passion­ ate and persistent disagreement. humans disagree regarding (1) the moral significance of their sexuality in disputes about surrogate motherhood and artificial insemination by donors, (2) the moral significance of interferences with and termination of early human life with regard to embryo research and abortion, (3) the nature of justice, (4) the claims of equality, and (5) the status of private possessions as bearing on the allocation of resources for health care, as well as (6) end-of-life decision-making, as in the case of physician-assisted suicide and euthanasia. bioethical matters occasion significant battles in the culture wars. 15 disputes with respect to organ transfer are no exception. humans not only dispute the ranking of cardinal values such as liberty, equality, prosperity, and security, they disagree regarding the powers of human rationality and the existence of ultimate meaning, regarding god's existence and god's requirements, and regarding the character of morality, rationality, and reasonableness. consequently, there is no common basis in terms of which such foundational disputes can be resolved by sound rational argument. that is, there are strong grounds for concluding that these disagreements are irresolvable through discursive secular reflection, because the disputants fail to agree about basic moral premises and rules of moral evidence and inference. this state of affairs has been well recognized for over two thousand years. 16 according tot. flavius clement (circa 150-215 a.d.) of alexandria, egypt, everything depends on the basic premises from which one starts. as clement puts it, "should one say that knowledge is founded on demonstration by a 15. jambs davison hdr-iter, culture wars: the struggle to define amerjca (1991). 16. the irresolvability of moral controversies was well appreciated by protagoras (481411 b.c.), who, as diogenes laertius observed, "was the first to maintain that there are two sides to every question, opposed to each other, and he even argued in this fashion, being the first to do so" (1x.8.51 ). diogbnbs laertius, 2 lives ofeminentphudsophers 463 (r.d. hicks trans., harvard univ. press 2000) (1925). 2004] conflicting views of organ transfer 37 process of reasoning, let him hear that first principles are incapable of demon­ stration; for they are known neither by art nor sagacity."17 in the face of fundamental disagreement about the existence of god and the nature of morality, one is left with a default strategy of deriving authority neither from god nor from a canonical understanding of moral rationality, but instead from individuals. if one cannot agree about god's wishes, or as to which moral understanding or account of rationality ought to govern, one can at least derive authority from the peaceable consent of those who participate in a project. this strategy lies behind the moral authority on its face of un­ coerced, non-fraudulent market exchanges, contracts, and agreements. given disagreements about god's wishes and the nature of moral obligation, indivi­ duals can recognize themselves as the source of authority for peaceable colla­ boration. if one cannot uncontroversially draw authority from god or from a particular account of the morally rational or reasonable, then one can at least derive authority from those individuals who convey that authority through consent. 18 this state of affairs has at least two important consequences. first, it condemns humans to a moral pluralism, although not necessarily a moral relativism. second, it condemns humans to a moral-epistemological skepti­ cism, albeit not to a moral-metaphysical skepticism. 19 if definitive moral knowledge is to be possessed by humans, it must be acquired by some special route to knowledge and will not be open to all.20 by default, a general secular defense of the moral authority of governments will at best secure authority for a limited government with limited authority to intrude into the peaceable agreements of citizens. in particular, these observations regarding moral con­ troversies and the centrality of individual consent in resolving controversies in the face of moral disagreement give strong grounds for presuming that 17. clement of alexandria, the stromata ii.4, in 2 ante-nicene fathers 350 (alexander roberts & james donaldson eds., hendrickson publishers 1994). 18. the point of relying on permission, given deafness to god's wishes and numerous competing secular accounts of moral rationality, is that this source of authority involves the least initial presupposition as the basis for a common secular morality-namely, the sparse agreement that there are persons who can consent to common, collaborative undertakings. see h.t. engelhardt, jr., bioetj:llcs and secular humanism: the search for a common morauty (1991). 19. the circumstance that one cannot resolve moral controversies by discursive rational analysis and reflection does not give grounds for denying the existence of an objective moral truth, only of the ability of discursive rationality to identify that truth. for a further exploration of these issues, see h.t. engelhardt, jr., the foundations of christian bioethics ch. 4 (2000). 20. the traditional christian anthropology recognizes fallen man as unable to exercise a fundamental human cognitive faculty: the heart or the nous, through which the knower can know the known without mediation. see, e.g., st. symeon the new theologian, on the mystical life, (alexander golitzin trans., 1995); sts. nikodimos and makarios, 1 the philokaua (g.e.h. palmer et al. eds. & trans., 1979). only those whose heart or nous is spiritually healthy are able to know in a morally reliable fashion. such knowledge will not be available for the general secular resolution of moral controversies. see, e.g., john s. romanides, the .ancestral sin (georges. gabriel trans., zephyr publishing 2002) (1957). 38 indiana heal'ih law review [vol. 1:29 individuals may, within the horizon of imminence, morally act on their own not only to give their organs, but to sell them as well. ll. puzzles regarding the authority of states over their citizens how can one explain the tendency to prohibit organ sales? what would make it plausible to embrace such a prohibitive policy, since it may cost human lives in making fewer organ8 available? . first, despite the foregoing observations regarding profound moral, philosophical, and theological dis­ agreements, which favor placing persons and their moral authority central to any account of the transfer of organs, humans nevertheless have a strong proclivity to deny their robust moral disagreements or otherwise discount them. they do so through various invocations of rationality, reasonableness, and consensus. that is, despite profound disagreements regarding the moral significance of sexuality, reproduction, property, suffering, dying, and death, particular public policies are justified by claiming one particular moral pers­ pective to be grounded in a consensus or to be otherwise nonnative. in the process, contrary views are often dismissed as non-mainstream or unreason­ able, even if disagreement is robust, and there is no conclusive sound rational argument to establish any one particular view.21 the appeal of such strategies is manifest. they serve to establish the intellectual class as authorities who can disclose the content of morality and the foundations of appropriate public policy.22 if moral reflection were not beset by the fundamental controversies that plague it, philosophers would be specially advantaged in being able to justify the originary moral authority of the state and its policies through their account of rationality. philosophers could then show that coercion on behalf of this rationality is really restorative of true human rational autonomy.23 in addition, philosophers could declare 21. for example, although 1ohn rawls admits that his account of justice is not grounded in a rational foundationalism but instead in a freestanding view, he dismisses from the domain of reasonable pluralism those accounts of polity that do not conform with his social..democratic understanding (this would exclude from the scope of a reasonable pluralism both those supporting libertarian accounts and limited democratic accounts of polity). 10hn r.awis, polmcalliberausm 36 (1996). 22. the claim of moral knowledge involves the arrogation (justifiably or not) of authority and therefore power over others. see, e.g., michel foucault, power/knowledge (colin gordon ed., colin gordon et al. trans., 1980). claims to knowledge can also establish and pro­ tect political power. this is a point also made by karl marx and friedrich engels regarding those intellectuals who support the reigning ideology. that is, those who are "conceptive ideolo­ gists, who make the perfecting of the illusion of the class about itself their chief source of livelihood." karl marx & frmorichenom.s, the german ideology 40 (cj. arthur ed., lnt'l publishers 1st ed., 1972). . 23. a classical statement of this view regarding the rational justification for coercive state authority is provided by immanuel kant: any opposition that counteracts the hindrance of an effect promotes that effect and is consistent with it now, everything that is unjust is a hindrance to free­ dom according to universal laws. coercion. however, is a hindrance or opposi2004] conflicting views of organ transfer 39 that all humans are really members of one moral community, grounded in the moral commitments affj.i'id.ed by those philosophers, fundamental disagree­ ments to the contrary notwithstanding. to accomplish this feat, however, others must also grant the needed initial moral premises and rules of moral inference. as the third .:.century skeptic agrippa appreciated, philosophical disputes involving competing basic moral premises and rules of moral evidence inevit­ ably beg the question, argue in a circle, or engage an infinite regress. 24 claims of the triumph of a particular-moral·rationality to the contrary notwithstanding, it is not possible to provide a conclusive secular rational warrant for a parti­ cular moral rationality, thus supplying unique rational moral authority to a particular public policy. we are left asking whose moral rationality and which view of human good and human flourishing should govern. sound rational argument is unable to deliver a conclusive answer.25 yet, out of interests of power over others, one can appreciate why the controversial character of human morality is often discounted, if not denied, by those in authority. for example, despite the controversial character of morality, many doggedly invoke particular normative senses of the secularly reasonable or the fair as unquestionably canonical in order to anoint their favored policies.26 john rawls and jurgen habetmas, for example, embrace a particular view of the reasonable or the ethics of discourse. n they pack their own partition to freedom. consequently, if a certain use of freedom is itself a hindrance to freedom according to universal laws (that is, is unjust), then the use of coer­ cion to counteract it, inasmuch as it is the prevention of a hindrance to freedom, is consistent with freedom according to universal laws; in other words, this use of coercion is just. it follows by the law of contradiction that justice [a right] is united with the authorization to use coercion against anyone who violates justice [or a right]. immanuel kant, themetaphysicalei..ements ofjustice35-36 [ak vi 231] (john ladd trans., bobbs-merrill1965) (1797). 24. from classic times it was appreciated that arguments could not be settled among parties who did not share a common understanding of the problem at hand, the basic premises that should be embraced, and the rules of evidence that should be engaged. this led to the affir­ mation of what was referred to as the pente tropoi, or five modes of appreciating the irresolv­ ability of such controversies due to (1) the de facto interminability of philosophical disputes, (2) arguments involving an infinite regress, (3) the differences in perspective of the disputants, (4) the begging of what is at issue due to what initial premises are accepted, and (5) the circularity of most foundational reasoning. see sextus empiricus, 1 outijnes of pyrrhon­ ism i 95 (1976). this view was attributed to the school of agrippa. diogenes laertius, 2 lives of eminent philosophers ix 8, p.501 (r.d. hicks trans., 2000) (1925). 25. for a study of the ambiguities involved in identifying a canonical account of moral rationality and/or justice, see alasdair macintyre. whose justice? widch rationauty'? (1988). 26. one might consider the invocation by francis fukuyama of ''factor x'' as a ground for human dignity. francis fukuyama, our pos1'human future: consequences of the biotechnology future 149 (2002). 27. see, e.g., johnrawls,pouticalliberalism (1996); jorgenhabermas, theorie des kommunikativen handelns (1981). 40 indiana heal1h law review [vol. 1:29 cular moral and metaphysical commitments into their sense of reasonableness or proper discourse, without a grounding justification. rawls begins by accep­ ting "a pluralism of incompatible yet reasonable comprehensive doctrines."28 however, what he gives with the one hand he takes back with the other. in a seemingly innocuous fashion, rawls acknowledges that his understanding of political liberalism and reasonableness "supposes that a reasonable compre­ hensive doctrine does not reject the essentials of a democratic regime."29 the essentials of rawls' democratic regime turn out to be the particular essentials of a social democratic regime that requires ensuring in a fairly comprehensive fashion to "all citizens adequate all-purpose means to make effective use of their freedoms."3° cardinal terms are interpreted so as to include and exclude particular understandings of fairness and rationality. for instance, norman daniels (a student of rawls) and james sabin define fair-mindedness and fair­ minded people as those "who in principle seek to cooperate with others on terms they can justify to each other."31 however, here again we face the core difficulty: humans are separated by incompatible moral views and metaphys­ ics. consequently, individuals in a secular society will not be able to establish how others should collaborate with each other unless they already grant foundational premises and rules of moral evidence. in the face of this difficulty, the notion of consensus is nevertheless often invoked. 32 there is, though, a crucial disparity between the etymological meaning of consensus as unanimous agreement and the way in which consensus is invoked as a rhetorical ploy. 33 at least four senses of consensus must be distinguished: (1) consensus as an agreement among all parties as to the . authority of a policy and the reasonableness of compli­ ance;34 28. rawls, supra note 21, at xvi. 29. id. 30. ld. at6. 31. norman daniei.s & james sabin, se'iting limrrs fairly: can we learn to share medical resources'? 44 (2002). 32. theconcepi'ofmoralconsensus (kurt bayertz ed., 1994); h.t. engelhardt, jr., consensus formation: the creation of an ideology, 11 cambridge q. of healthcare ethics 7 (2002). 33. in latin, consensus means feeling together, or being of one mind, as an "agreement, accordance, unanimity, concord." charlton t. lewis, a latin dictionary 428 (rev. ed. 1980). the first edition of the oxford english dictionary defines consensus as "agreement in opinion; the collective unanimous opinion of a number of persons." 2 oxford engush dic­ tionary 851 ( lst ed. 1933). webster's new collegiate dictionary primarily defines consensus in tenns of "group solidarity in sentiment and belief' and "general agreement ... the judgment arrived at by most of those concerned." webster's new collegiate dictionary 238-39 (1981). 34. consensus in this sense comports with its etymology and identifies unanimous agreement: a social condition rare, if not non-existent, in moral and political debates. 2004] confucting views of organ transfer (2) consensus as an agreement among rulers, among those in political power, regarding the morality to which their subjects may rightfully be forced to comply. consen­ sus focuses on the rulers' self-appreciation as being in moral authority to effect the policy they endorse. con­ sensus in this case usually functions as an ideology.35 (3) the third sense is consensus as an agreement among rulers, among those in political power, regarding the public policy to which their subjects will be forced to comply. consensus focuses on a political program em­ braced because of its political usefulness with respect to political stability or the particular goals embraced by the rulers apart from any general moral justification,· so that the political is separated from morality, as it can be justified in general terms. 36 (4) consensus as an agreement among a sufficient majority so as to ensure political compliance of the minority. the minority is pressured to appreciate the prudence of submitting to the morality and public policy imposed by the majority. consensus functions as realpolitik.37 41 a further puzzle is that many invoke consensus in matters moral and political as an indication of the truth of such propositions, although broad agreements among humans regarding medical and scientific views do not appear closely connected to the truth. public consensus regarding the nature of the universe seems unconnected to the actual nature of the universe. 38 there are good grounds to be quite skeptical about the ability to draw secular moral authority for health care policies from a particular view of the morally rational or from a doctrine of the divine right of democratic majorities. this state of affairs should not bring one to embrace moral relativism or a moral-metaphysical skepticism regarding human morality. rather, one should recognize that, without special knowledge not open to all, it is impossible for humans to know when they know truly regarding a wide range of moral 35. "the ruling ideas are nothing more than the ideal expression of the dominant material relationships, the dominant material relationships grasped as ideas; hence of the relationships which make the one class the ruling one, therefore the ideas of its dominance." marx & engels, supra note 22, at 39. 36. this use of consensus identifies a workable coalition, against which there will always be minority opposition. 37. consensus here identifies a coalition powerful enough radically to reshape law and public policy, even if it fails to achieve unanimity. 38. public consensus in matters scientific is never sought as a basis for supporting scientific truth claims, for no one would hold that the general public consensus regarding the nature of the atom, of the character of infectious disease entities, would carry weight regarding the actual truth embraced. 42 indiana healm law review [vol. 1:29 claims. the more one confronts this defining state of affairs, the more one is pressed by default to acquiesce in limited governments that will, in general secular moral terms, be constrained to tolerate peaceable agreement, including a market in organs. because governments will not be able to justify by sound rational argument a morally canonical, totalizing, public policy, persons and regimes will be constrained by default to recognize moral rights of privacy within which peaceable collaboration, including the buying and selling of organs, will need to be tolerated. ill. the moral significance of the commodification of organs many authors nevertheless criticize · certain market transactions as improperly commodifying particular services or resources. 39 others regard such commodification as, at the very least, useful, if not noble, emphasizing that the market treats individuals as autonomous agents able to freely and peaceably collaborate with others so that market exchanges constitute a special example of the triumph of human freedom. 40 still ·others hold that the market improperly objectifies particular services, such as medical services, while others celebrate the market distribution of medical services as the means that most efficiently makes available health services without compromising human freedom.41 matters are surely complex with regard to commodification and sales. for example, voluntary military service offers a robust example of voluntary servitude in which persons give to others the right to enforce performance of services in exchange for food, pay, and special benefits. in contrast, when persons decide to sell their organs or tissues, it is not they who are commodified, but a part of their bodies which they freely decide to objectify and to trade in order to secure particular benefits. remarkably, there is less secular moral objection to the sale of renew~le tissues such as blood, sperm, and ova than to the sale of organs, although many recognize the use of donor sperm and ova as involving a kind of adultery or at least fomication.42 however, the distinction between being a renewable or non-renewable tissue 39. waltzer, for example, argues that while the proper sphere of money includes "all those objects, commodities, products, services, beyond what is communally provided, that individual men and women find useful or pleasing," certain exchanges ought to be prohibited in order to set limits on the dominion of wealth. michael walzer, spheres of justice: a defense of pluraljsm and equauty 103 (1983). see also m.j. radin, contested commodities (1996); m.j. radin, reinterpreting property (1993); m.j. radin, market­ inalienability, 100 harv. l. rev. 1849 (1987). 40. see cherry, supra note 5. 41. for an analysis of issues involved in the commodification of medical or health care, see david friedman, should medicine be a commodity? an economist's perspective, in righi's to health care 259 (thomas j. bole, ill & william b. bondeson eds., 1991). 42. for an account of the traditional christian objection to artificial insemination from a donor, see charles j. mcfadden, medical ethics 53 (5th eel. 1961); harmon l. smith, ethics and the new medicine 62 (1970). 2004] confucting views of organ transfer 43 would appear to bear not on the matter of commodification, but more on the risk of losing a tissue or organ one might later need. 43 two contrasting moral visions or life-worlds are at stake. on the one hand, there is an affirmation of a set of intuitions supporting the view that the dignity of humans is harmed when human organs or important services are made objects of market transactions.44 others recognize that the market affirms the dignity of persons, in that participants are treated as moral agents with the capacity to responsibly trade goods and services.45 at issue are conflicting visions of moral dignity. the first interpretation supports condem­ ning the sale of organs as undermining the dignity of humans, whereas the second supports recognizing the sale of organs as an expression of human autonomy and dignity. given the difficulty of resolving moral controversies and of establishing the authority of the secular state, the default position would again appear to be in the favor of those who affirm the market, because the market can be justified in terms of the consent of its participants. when there is no common view of what god requires or which moral vision, rationality, or account of reasonableness should govern, one is, by default, left with allowing individuals peaceably to choose and collaborate as they agree: hence the salience of the free market, contracts, and limited democracies. this acquiescence in free choice need not imply approval of what is allowed to be chosen or undertaken. one may have a special insight into the evils of particular choices, yet recognize no secular moral authority to interfere with coercive state force. many of the strong intuitions against a market in organs derive from a secular displacement of prior religious views. the earth's dominant culture is post-christian; the major imperial powers of the nineteenth and twentieth centuries passed from being christian to being post-christian cultures. one would expect to fmd shards and pieces of christian religious moral views that might give grounds to opposing a market in organs, considering the traditional christian opposition to mutilation. matters are complex. opposition by the church of the first thousand years to mutilation of the human body was based on a recognition of the sanctity of the body as a temple of the holy spirit and the necessity of accepting and honoring the gendered body given to one by 43. whether a kidney or a pint of blood is sold, in each case the object is rendered a conunodity in trade. a crucial difference lies in the renewability of the blood sold. stephen wear et al., the commercialization of human body parts: public policy considerations, in persons and their bodies: rights, r.esponsmllities, r.elationsidps, supra note 2, at 377. 44. for studies of these issues, see, e.g., perry, supra note 4; r. arneson, commodifica­ tion and commercial su"ogacy, 21 phil. & pub. aff. 132 (1992). see, also, jeffrey m. protias, the most useful gift: altruism and the pubuc poucy of organ transplants (1st ed. 1994). 45. see cherry, supra note 5. 44 indiana health law review [vol. 1:29 god: the focus was primarily on castration.46 this view was transformed by western christianity into the roman catholic moral and theological­ philosophical doctrine of the principle of totality, which came to affirm that a tissue or organ ought to be removed only when the excision supported the health of the body as a whole.47 this view found a classical articulation in the arguments of thomas aquinas, who in his summa theologica held that a part of the body could be removed only if this was necessary to preserve the health of the body as a whole.48 this doctrine led some roman catholic medical­ moral theologians to worry about the permissibility of incidental appendectomies: the removal of a healthy appendix when performing another operation with the goal of avoiding the possible risks of a future appendicitis. 49 despite rather robust concerns, given the principle of totality regarding the removal of healthy organs, western christian reflection until the latter part of the twentieth century was not opposed in principle to financial 46. for example, canon xxii of the apostolic canons (canons attributed to the apostles and welllatown in the fourth century) specifies: "let no one who has mutilated himself become a clergyman; for he is a murderer of himself, and an enemy of god's creation." john nicoledles, 'nm rudder of tile 0r1hodox cathouc church: 'nm compilations of tile holy canons by saints nicodemus and agapius 34 (d. cummings trans., orthodox christian education society 1957, repr. 1983) ( 1800). as canon vid of the first-and-second council argues, "such a person [is] quite guilty of insulting creation itself." id. at 465. this canon makes reference to a similar canon (canon i) from the council of nicea (a.d. 325), which states that it is not the mutilation itself that is forbidden, but mutilation for particular prohibited reasons, in that the canons specifically exempt castration when it is part of the surgical treatment of a disease. /d. for precisely as the first canon of the council held in nicaea does not punish those who have been operated upon for a disease, for having the disease, so neither do we condemn priests who order diseased men to be castrated, nor do we blame laymen either, when they perfonn the operation with their own hands. for we consider this to be a treatment of the disease, but not a malicious design against the creature or an insult to creation. 47. for a manualistic encapsulation of the principle of totality, see gerald kelly, medico-moral problems 8-11, 246 (1958). see also mcfadden, supra note 42, at255-58. 48. since a member is part of the whole human body, it is for the sake of the whole, as the imperfect for the perfect. hence a member of the human body is to be disposed of according as it is expedient for the body. now a member of the human body is of itself useful to the good of the whole body, yet, accidentally it may happen to be hurtful, as when a decayed member is a source of corruption to the whole body. accordingly so long as a member is healthy and retains its natural disposition, it cannot be cut off without injury to the whole body . . . . if, however, the member be decayed and therefore a source of corruption to the whole body, then it is lawful with the consent of the owner of the member, to cut away the member for the welfare of the whole body, since each one is intrusted with the care of his own welfare. the same applies if it be done with the consent of the person whose business it is to care for the welfare of the person who has a decayed member: otherwise it is altogether unlawful to maim anyone. thomas aquinas, summa 'nmologica 11-ii, q.65, a 1 (1947). 49. see, e.g., patrick finney & patrick o'brien, moral problems in hospfl'al practice (1956); kelly, supra note 47, at 252-54; mcfadden, supra note 42. 2004] confucting views of organ transfer 45 compensation, and especially not to compensation for providing tissues and organs after death. one might consider, for example, the statement by pope pius xll to a group of ophthalmologists regarding corneal transplantation: moreover, must one, as is often done, refuse on principle all compensation? this question remains unanswered. it cannot be doubted that grave abuses could occur if a payment is de­ manded. but it would be going too far to declare immoral every acceptance or every demand of payment. the case is similar to blood transfusions. it is commendable for the donor to refuse recompense; it is not necessarily a fault to accept it. 50 by making reference to payments for blood transfusions, pius xll opened the possibility for payments for the sale of organs and tissues from live donors (as long as this would not offend the roman catholic principle of totality). in short, pius xll's attitude toward the provision of, not to mention compensation for, blood and tissue sales was less prohibitory than the position taken by philosophers such as immanuel kant. 51 it must be noted that immanuel kant did not distinguish between buying and giving body parts, holding that in each case there is a violation of persons as ends in themselves. 52 the cardinal difficulty for a position such as kant's is that it depends not on the general requirements of universal moral rationality as he alleges, but instead on a very particular content-rich account of moral rationality. kant employed this rationality in order to attempt a secular reconstruction of his protestant pietist sensibilities. this content was then assumed as a part of his view of what can consistently be willed, not what can actually be willed 50. pius xii, address to a group of eye specialists (may 14, 1956), in papal teacidngs: the human body 381-82 (monks of solesmes eds., 1960). 51. roman catholic moral theologians have come to view market solutions as compatible with acts of charity, as when one would sell an organ at below-market price, or when the purchaser benefits the poor person by paying in excess of what the market might demand. "[l]n a wide sense, almsgiving includes selling on credit as a favor to a poor customer; a loan granted at a low rate of interest or without interest, help in securing employment, etc." james mchugh & c. callan, moral theology 495 (1960). a similar position is taken by mark cherry: removal of a healthy human organ would be permissible even if one accepts or requests monetary compensation, or other valuable consideration, provided that one does not exploit those in need by demanding too great a fee, although, presumably, a poor individual could ask for greater compensation from a rich recipient. one could view this possibility as consonant with the reflections of certain theologians on the priority one should give the poor. cherry, body parts, supra note 4, at 186. 52. "to give away or sell a1 tooth so that it can be planted in the jawbone of another person •.• belongs to partial self-murder." immanuel kant, themetaphysicalprinciples of virtue 84 [ak. vi 423] (james ellington trans., bobbs-merrilll964). 46 indiana healm law review [vol. 1:29 without contradiction. 53 thus, for example, kant argued that masturbation was worse than suicide.54 in this vein, he argued that selling one's hair is not without moral fault. 55 among the many difficulties with kant's arguments is that in these particular areas they are underdeveloped. more crucially, because of kant's dependence on a particular view of moral rationality, the default position places consent centrally so that, pace kant, using persons as means merely becomes using them without their consent. 56 in this context, a strong argument against the commodification of organs collapses. one must suspect' that the contemporary opposition to the sale of organs may represent a late twentiethand early twenty-fust-century response to a number of phenomena. on the one hand, opposition may reflect particular non-market ideologies that in the case of organ sales recognize an opportunity to limit the role of market transactions. opposition may also reflect the outcome of disconnecting western christian moral intuitions and sentiments from the comprehensive moral-metaphysical-theological system that once placed these intuitions and sentiments within a framing metaphysical account of deep meaning. those sentiments are then without a context to guide them and become merely taboos in the sense of oppositional moral intuitions lacking a sustaining justification. as a consequence, in the post-traditional ruins of christendom, these intuitions and sentiments can lead to paradoxical moral positions. for example, there is often a greater opposition to organ sales involving the consent of all parties than to abortion, which involves the unconsented-to killing of an unborn child. from a traditional christian moral perspective, the secular ordering of moral concerns in this matter is at best perverse: it is more concerned with an alleged evil in the sale of organs than 53. kant, who identifies morality with rationality by establishing certain categories of behavior as irrational, invokes three kinds of contradictions in order to establish the constraints of his categorical moral account: (1) undertakings that would be strictly logically contradictory, such as invoking the practice of truth-telling while intending to lie; (2) undertakings such as suicide that would, if universalized, cause the kingdom of ends no longer to be instantiated; and (3) undertakings that can be willed without contradiction and without having as its implication the disappearance of the kingdom of ends, but that still involve a commitment that kant holds persons are not capable of consistently affirming, such as willing never to give to those in need while supposedly willing as well to forgo charity, should one be in need. often. kant fails to make clear where the contradiction is supposed to lie. for example, kant argues, regarding the transfer of an organ, that ''to dispose of oneself as a mere means to some end of one's own liking is to degrade the humanity in one's person, which, after all, was entrusted to man to preserve.'' see kant, supra note 52, at 84 [ak vi 423]. it is clear that kant holds that it involves treating oneself as a means merely, if one deprives "oneself of an integral part or organ (to mutilate oneself)." id. at 84. however, he does not show where the logical contradiction in such use lies. 54. "but this does not make evident the high degree of violation of the humanity in one's own person by the unnaturalness of such a vice, which seems in its very form (disposition) to transcend even the vice of self-murder." ld. at 86-87 [ak vi 425]. 55. "also, it cannot be reckoned a crime against one's own person to cut off something which is, to be sure, a part, but not an organ of the body, e.g., the hair, although selling one's hair for gain is not entirely free from blame.'' id. at 84. 56. h.t. engelhardt, supra note 3, at ch. 4. 2004] confucting views of organ transfer 47 in the taking of unborn life. in any event, it is not apparent how organ sales could be forbidden on the basis of concerns regarding the commodification of human persons in the absence of conceding a set of very particular initial moral premises. iv. exploitation a candid assessment of the character of moral claims in a secular, post­ traditional, post-modem culture by default renders the authority of individuals over themselves salient, while bringing into question the authority of governments over their citizens, so as substantially to limit the plausible secular moral authority to prohibit the sale of human tissues and organs. if there is to be a general secular basis for a prohibition in principle of organ sales, it will need to be grounded in finding such a market to be in some sense improperly using or exploiting would-be sellers. towards that end, one can display at least three senses of exploitation in the market:57 first, offering a fmancial inducement that overrides the would-be seller's capacity freely to consent; second, offering a fmancial inducement that brings the would-be seller to assume a morally unacceptable risk of death, harm, and disability; and third, offering a fmancial inducement to engage in an activity that is either (a) morally prohibited or (b) held to be morally wrong by the person subject to the inducement. each engages a different sense of the malum involved in offering a financial inducement to would-be sellers. the first concern, that a fmancial inducement will override the capacity to consent freely, must be distinguished from the circumstance that offering an inducement, all else being equal, will assuredly entice a person to accept that inducement. imagine being offered a million dollars to sweep the side­ walk in front of one's house. presuming no special religious prohibitions concerning laboring on that particular day, etc., one can be confident that such a fmancial inducement will always, or nearly always, produce agreement. this circumstance does not argue against free choice, even if only multi-billionaires are likely to decline. instead, the near-inevitability of consent discloses that certain benefits associated with low levels of harms will usually be embraced by most rational decision-makers. the circumstance that a monetary induce­ ment to a person in financial need will nearly certainly produce agreement does not establish that the person's freedom has been overridden. 57. complex issues are at stake in concerns regarding exploitation, including the role of coercion and manipulation. see arthur caplan, if i were a rich man, could i buy a pancreas? (1992); alan wertheimer, exploitation (1996); joel feinberg, non-coercive exploitation, in paternalism 201 (rolf sartorius ed., 1983); m. gorr, toward a theory of coercion, 16 can. j. phh... 383 (1986); d. miller, exploitation in the market, in modern theories of exploitation 149 (andrew reeve ed., 1987); robert nozick, coercion, in phn..osophy,science,andmethod44(sidneymorgenbesseretal.eds.,l969);joelrudinow, manipulation, 88 ethics 338 (1978); david zimmerman, coercive wage offers, 10 phll... & pub. aff. 121 (1981). 48 indiana healm law revjew [vol. 1:29 second, a moral assessment of the licitness of financial inducements on the grounds that the inducements will likely entice a person to assume a risk of death or disability must consider two crucial issues: (1) the magnitude of the risk of death and disability, as well as (2) what the person's risk would have been, absent being induced to assume the new profiles of risk. first, with regard to the sale of organs after death, the risk of having the time of one's death improperly advanced would appear no greater than under circumstances of "donation." second, the risk from selling one of a paired organ or some other conveyance of tissue compatible with continued life should ceteris paribus be no greater than that involved in the donation of such organs. third, with respect to the issue of organ sales, the assessment of risk requires not just an assessment of the risk associated with having an organ removed, but also a judgment as to whether the consequences of the financial gain from the sale will on sum lower the seller's morbidity and mortality risks. the point is this: if in a developing country a person will, by selling a kidney, move from near-poverty with a high risk of disability and early death to a middle-class position with a lower risk of disability and early death (e.g., by allowing the organ seller to open a bicycle shop so as not to need to engage in high-risk manual labor), then on any rational assessment the sale will advantage the individual. this judgment is bolstered by the circumstance just noted. namely, one generally allows persons out of altruism to donate kidneys to their relatives, and there is no reason to infer that there will be a higher risk to sellers than to donors. the risk assumed by donors is one that surgeons generally consider acceptable. organ sales differ from organ donations only in that the benevolence involved is directed not to the recipient, but to the seller and the family of the seller, while the purchaser still receives an important good. ceteris paribus, the seller of the organ should be at no greater risk than a living donor. the bottom line of these considerations is that there is no basis to hold that in principle morally inappropriate exploitation will occur. there is no good evidence that allowing sales under the same oversight as the current practice of organ donation would produce excess risks. all would seem to turn on developing particular policies with particular protections for sellers and donors against fraud, coercion, and poor-quality medical procedures. the remaining concern regarding exploitation, namely, that there is exploitation because of the character of the sale itself, requires a showing that the sale of an organ is intrinsically wrong or on balance harmful in a way in which organ donation is not. given the failure by sound rational argument to establish the canonical governance of a particular content-rich moral vision, such as that of immanuel kant, this does not seem feasible. the default position for determining whether it is proper or improper for competent adult individuals to engage in particular peaceable endeavors is to rely on their consent, at least when the endeavors do not appear on balance to involve harms beyond those regularly accepted in the society (e.g., riding motorcycles, using hang-gliders, etc.). again, if the crucial matter is that of risk, the 2004] confucting views of organ transfer 49 potential for harm exists whenever living donors are utilized, regardless of whether money changes hands. 58 v. rethiniang organ 'transfer poucy these reflections have not shown that it would be good to establish a market in human organs. rather, they bring into question the plausibility of a secular moral ground for the coercive state prohibition of such transfers. the more it appears empirically plausible that a market in organs from corpses, from sales of the future right to take an organ at death, or from sales from living vendors will make more organs available and therefore save the lives of persons at risk, while involving no secularly cognizable harms, then the more difficult it becomes in secular moral terms to prohibit such a market, especially given the moral-philosophical reflections just advanced. this analysis is not meant to deny that there may be important religious moral insights into these matters that might morally limit participation in a market.59 rather, it confronts the circumstance that secular morality by default places the authority of persons centrally, thus bringing into question the moral authority of states to prohibit peaceable, voluntary agreements, such as those involved in organ sales. it is difficult to establish a clear secular moral malum associated with the commodification of organs, or that such markets must involve the exploitation of sellers. these considerations do not militate against establishing safeguards for sellers.60 indeed, there are very strong grounds for establishing public policy that would assure that sellers are operated on under safe conditions and that they are actually paid that for which they contracted, commensurate with the contract price. these, and a rich set of other considerations, provide substantive grounds for protecting sellers. these considerations do not provide general secular moral grounds for a prohibition in principle. 58. for the relative medical (i.e., morbidity and mortality) costs and benefits of utilizing living donors see patricia l. adams et al., the nondirected live-kidney donor: ethical considerations and practice guidelines: a national conference report, 74 transplantation 582 (2002); c.o. callender et al., increasing living donations: expanding the national moitep community grassroots model, 34 transplantation proc. 2563 (2002); lainie friedman ross et al., should all living donors be treated equally?, 74 transplantation 418 (2002). 59. see engelhardt, supra note 3. 60. for an account of a program to protect live sellers of organs, see k.c. reddy et al., unconventional renal transplantation in india, 22 transplantation proc. 910 (1990). history of the mcdonald-merrill-ketcham memorial lecture and award the story of this award and lectureship begins with a visionary alumna of indiana university: dorothy m. ketcham. miss ketcham received her bache­ lor of arts in economics in 19 i 4 and her master of arts in sociology the follow­ ing year. she joined the faculty of the university of michigan in 192 i. in 1922, she became director of social services at the university ofmichigan hos­ pital. in this capacity, she saw the important role that medicine and law played in the lives of those whom she served. in 1928, she established a multifaceted workshop and recreational facility for children confined to the hospital. while at the university she also wrote several books, two of which were devoted to hospital law. miss ketcham's affinity for the law grew out of her family's close rela­ tionship with the legal system. her grandfather, david mcdonald, was a prac­ ticing attorney in indianapolis, as well as a circuit judge. he was appointed to the united states district court in 1864 where he served until his death. doro­ thy's father, william a ketcham, was a well known indianapolis attorney. prior to being admitted to the bar in 1869, he studied law with his father, john l. ketcham and judge david mcdonald. william ketcham was elected to the office of state attorney general in 1894 and served two terms. miss ketcham's interest in health related law extended beyond her scholarship. in a trust she established for herself and four of her sisters (miss flora mcdonald ketcham, dr. jane m. ketcham, and misses lilla and lucia ket­ cham), she made a remainder gift to the indiana university foundation to be used to assist the university in developing programs that would foster a greater understanding and better relations between the professions of law and medi­ cine. miss ketcham was especially interested in furthering the careers of young medical and law students and instilling in them an appreciation for both profes­ sions. miss ketcham's generous gift, named for her grandparents (judge david mcdonald, john l. ketcham, and jane merrill ketcham), funds this prestigious lectureship and award for an individual who has demonstrated excellence in the fields of common interest to the two professions. it is fitting that the university honor miss ketcham's wishes by bringing to our campus distinguished scholars and leaders who bridge the gap between law and medicine. by inviting them to share their expertise with students, faculty, and leaders of the legal and medical professions, we continue to support the ideals that dorothy m. ketcham es­ poused in her life and work in recent years, the lecture and award have been made in collaboration with the medical humanities program, a new interdisci­ plinary project based in the school of liberal arts. this addition further inte­ grates law and medicine into the academic community and encourages each discipline to think of itself in relation to others. mcdonald-merrill-ketcham memorial lecture and award in conjunction with the indiana university school ofmedicine, the indi­ ana university school of law -indianapolis sponsors the annual mcdonald­ merrill-ketcham memorial lectureship and award for excellence in law and medicine. supported by a bequest to the two schools, this lectureship and award brings leading scholars and policy makers in the fields oflaw and medi­ cine to the indianapolis campus for the benefit of the students, faculty, bar, and the medical community. the inaugural program was held in november 1994. award recipients and their articles are listed below. articles based on the lectures presented were published in the indiana law review until 2002, after that time the indiana health law review assumed responsibility for hosting and publishing all arti­ cles generated by the annual lecture. • 1994 tom l. beauchamp, professor of philosophy and senior re­ search scholar at the kennedy institute at georgetown university. the justification of physician-assisted deaths, 29 ind. l. rev. 1173 (1996). • 1996 frances h. miller, professor of law at boston university school of law and professor of public health at boston university school of medicine. health care information technology and in­ formed consent: computers and the doctor-patient relationship, 3 ind. l. rev. 1019 (1998). • 1997 troyen a. brennan, professor of law and public health at harvard school of public health and professor ofmedicine at harvard school of medicine. beyond dead reckoning: measures of medical injury burden, malpractice litigation, and alternative compensation models from utah and colorado, 33 ind. l. rev. 1643 (2000). • 1998barry s. levy, immediate past president ofthe american public health association and adjunct professor of community health at tufts university school of medicine. twenty-first century chal­ lenges for law and public health, 32 ind. l. rev. 1149 (1999). • 1999bernard lo, professor of medicine and director ofthe program in medical ethics at the university of california, san francisco. con­ fidentiality of prescription drug information in the era of computers and managed care, 33 ind. l. rev. 937 (2000). • 2000clark c. havighurst, william neal reynolds professor at duke university school of law. the backlash against managed care: hard politics make bad policy, 34 ind. l. rev. 395 (2001). 440 indiana health law review (vol. 5:439 • 2001robert j. levine, professor ofmedicine and lecturer in phar­ macology at yale university school ofmedicine. international codes of research ethics: current controversies and the future, 35 ind. l. rev. 557 (2002). • 2002 -ruth r. faden, philip franklin wagley professor of biomedical ethics and executive director of the phoebe r. berman bioethics in­ stitute at johns hopkins university. liberty public health, and na­ tional security: the challengeofsmallpox, 1 ind. healtifl. rev.1 (2004). • 2003 h. tristram engelhardt, jr., professor of philosophy at rice university, professor emeritus in the department of medicine at rice university, and professor emeritus in the department of community medicine at baylor college of medicine. giving, selling, and having taken: conflicting views of organ transfer, 1 ind. healthl. rev. 29 (2004). • 2004 randall r. bovbjerg, research associate, health policy cen­ ter, the urban institute, washington, d.c. beyond tort reform: fix­ ing real problems, 3 ind. healtif l. rev. 1 (2006). • 2005 william m. sage, professor of law at columbia university, pay for performance: will it work in theory?, 3 ind. healthl. rev. 303 (2006). • 2006james f. blumstein, vanderbilt university law school, univer­ sity professor of constitutional law & policy, director of the health policy center, vanderbilt institute for public policy studies. of doc­ tors and hospitals: setting the analytical framework for managing and regulating the relationship, 4 ind. health l. rev. 209 (2007). • 2007george j. annas, edward utley professor and chair, depart­ ment of health law, bioethics and human rights, boston university school for public health. health care reform in america: beyond ideology, 5 ind. health l. rev. 441. saving money, not lives: why the va's claims adjudication system denies due process to veterans with post-traumatic stress disorder and how the va can avoid judicial intervention contessa m. wilson* i. introduction ............................................................................... 157 ii. background ................................................................................ 161 a. ptsd: clinical presentation, short-term, and long-term effects ....................................................................................... 161 b. va claims adjudication system: an overview ....................... l64 iii. analysis: federal district courts doha ve the power to grant a remedy .......................................................................... 167 a. facial constitutional challenges to va allowed .................... 167 1. establishment of standing ................................................. 167 2. establishment of waiver of sovereign immunity by the va ................................................................................ 168 a. final agency action .................................................... 170 b. no other alternate adequate remedy ........................... 171 b. applicable law: administrative procedure act (apa), congressional statutes, fifth amendment to the united states constitution .............................................................................. 171 c. application oftrac factor analysis and due process analysis to the va 's claims adjudication process ................................ 17 4 1. trac factor analysis ....................................................... 174 2. due process analysis ........................................................ 178 iv. recommendations ...................................................................... 183 v. conclusion .................................................................................. 186 l. introduction to care for him who shall have borne the battle and for his widow and his orphan: this is the motto ofthe department of veterans' affairs (va). frustrated by delays in health care, two veterans' advocacy groups, veter­ ans for common sense and veterans united for truth, questioned the va's commitment to their motto and filed a lawsuit in federal court seeking * j.d. candidate, 2010, indiana university school of lawindianapolis; phannd., 2002, university of shenandoah, bernard j. dunn school of pharmacy; m.s.m., 1994, pur­ due university, krannert school of business; b.s.pharm., 1991, purdue university school of pharmacy and pharmaceutical sciences. disclaimer: ms. wilson held a position as a staff pharmacist for the veterans administration. the views expressed here are solely those of the author and do not represent any of the institutions with which she is affiliated, now or in the past. 158 indiana health law review [vol. 7:157 change in the va's health care system. the advocacy groups charged that the va has failed to provide statutorily-mandated benefits to thousands of veterans, specifically those seeking medical treatment or disability claims based on post-traumatic stress disorder {ptsd). seeking declaratory and injunctive relief, and not monetary damages, the advocacy groups painted a disturbing picture of a va bureaucracy that, instead of living up to its mot­ to, abandons veterans, which ultimately leads to broken -lives, homeless­ ness, and staggering social costs. 1 the organizations pointed to documents and studies describing layers of failure on the part of the va to address not only the mental health needs of veterans returning from foreign wars, but the monetary benefits due these veterans as well.2 these statistics focused specifically on veterans returning from iraq and afghanistan with symptoms of ptsd.3 the organizations' lawsuit focused primarily on the following issues: 1) "[t]he widespread breakdown of the [va 's] adjudication and health care systems for veterans experiencing pstd'74, 2) "[t]he prolonged administrative delays in processing ptsd claims, at both the regional office and appellate levels"5, and 3) "[a] variety of statutory and regulatory impediments to a veteran's ability to collect ptsd compensation, [including] the inability to obtain discovery, ·the absence of subpoena power for documents and witnesses, and the inability to hire a lawyer to help out at the regional office level .'oli ptsd is one of the most common diagnoses of returning service members from iraq and afghanistan, with nearly nineteen percent reporting symptoms. 7 the prevalence of ptsd in veterans returning from war is dratnatic when compared to the prevalence of ptsd in the general public, which is only approximately four percent. 8 additional studies indicate that the suicide rate among veterans is approximately 3.2 times higher than that , 1. see generally veterans for common sense v. peake, 563 f. supp. 2d 1049 (n.d. cal 2008). · 2. see, e.g., peake, 563 f. supp. 2d at 1049; invismle wounds of war: psychological and cognitive injuries, their consequences, and services to assist recovery (terri tanielian & lisa h. jaycox eds., rand center for military health policy research, 2008) [hereinafter invisible wounds of war]; karen h. seal et al., bringing the war back home: mental health disorders among 103 788 us veterans returning from iraq and afghanistan seen at department of veterans affairs facilities, 167 arch intern med. 476 (2007). 3. see generally peake, 563 f. supp. 2d at 1055 (outlining plaintiffs' argument seek­ ing injunctive and declaratory relief against the va alleging that the procedures for obtain­ ing disability benefits violated veterans' rights). 4. veterans ptsd class action homepage, http://www.veteransptsdclassaction.orgl index.html (last visited march 8, 2009) [hereinafter ptsd homepage]. 5. id 6. /d. 7. peake, 563 f. supp. 2d at 1062, accord seal et al.,supranote 2, at478. 8. guido r. zanni, phd, ptsd: treating the wounds we do not see, 14 pharmacy times 44, 44 (2008). 2010] saving money, not lives 159 of the general population.9 not surprising is the fact that ptsd is a signifi­ cant risk factor for suicide,10 leading to the conclusion that treating ptsd, and thus avoiding its long-term implications, would inevitably prove to be a cost-effective strategy: not only in dollars, but in human lives as well. lack of access to statutorily-mandated health care and disability bene­ fits, however, is leading to serious long-term complications for veterans with ptsd, including a serious suicide epidemic. an adversarial claims adjudication process only serves to exacerbate the situation·11 only months after the lawsuit was filed, the va became aware, through an internal email, that eighteen veterans committed suicide each day and that the va's own data demonstrated that four to five of the suicides were among those who were receiving care from the v a.12 another internal va email, dated eight months after the lawsuit was filed, revealed that 12,000 veterans under va care attempted suicide each year.13 the financial costs associated with mental health and cognitive conditions stemming from the conflicts in mghanistan and iraq are substan­ tial. although confounded by a few uncertainties, the two-year costs for ptsd-related and major depression could range from $4.0 to $6.2 billion (in 2007 dollars).14 costs are being incurred in more than just dollars. in health terms, re­ search documents a relationship between ptsd and coronary heart disease ("chd"), 15 between ptsd and mortality, 16 and between ptsd and health­ compromising behaviors such as smoking, drug abuse, and alcohol abuse.17 ptsd and its resultant complications can ultimately lead to suicide and its related costs. veterans returning from iraq and afghanistan may, indeed, receive treatment from the va after seeking it. the quality and continuity of the treatment, however, is often dependent upon whether the veteran lives near a va facility that offers mental health care.18 "these shortfalls have reached a crisis point; with substance abuse, homelessness, family dis­ solution, and suicide at unacceptable levels."19 many veterans are totally or primarily dependent upon benefits re­ ceived based on their service. service-connected ratings, known as service­ connected death and disability compensation ("scddc"), determine the 9. peake, 563 f. supp. 2d at 1063. 10. kevin caruso, ptsd and suicide, http://www.suicide.org/ptsd-and-suicide.html (last visited march 8, 2009), accord peake, 563 f. supp. 2d at 1062. 11. ptsd homepage, supra note 4. 12. peake, 563 f. supp. 2d at 1063. 13. id 14. invtsmle wounds of war, supra note 2, at xxiii. 15. /d.atl3l. 16. /d. 17. /d. at 134-36. 18. amy n. fairweather, compromised care: the limited availability and question­ able quality of health care for recent veterans, aba human rights, spring 2008, at 4. 19. id. 160 indiana health law review (vol. 7:157 monthly payment made to a veteran who has a disability for a disease or injury that was incurred or aggravated by service in the armed forces.20 for those who cannot work [due to the incapacitating effects of ptsd], the difference [in a scddc rating] can be a lifetime of bare economic stability (with benefits topping out at about $2,500 per month for a single veteran with no dependants) or abject poverty (a 50 percent disability will net a veteran about $725 a month).21 the va not only has a statutory duty to allow veterans access to ap­ propriate health care and disability benefits, but a constitutional duty as well. and the burden to the va of treating those veterans afllicted with ptsd is lower than the burden of allowing the disease to remain un­ treated.22 in veterans for common sense v. peake, the court found that two vet­ erans' advocacy groups did have standing to bring their members' claims to the district court.23 although the court held that the system established by congress for adjudicating veterans' individual claims did not provide an adequate alternative remedy for plaintiffs' systemic facial constitutional challenges, the court found that plaintiffs' challenges failed for other rea­ sons, 'including failure to challenge a final agency action. '24 additionally, the court held that the grievances of the plaintiffs were misdirected and that the remedies of the problems, deficiencies, delays, and inadequacies com· plained of were not within the jurisdiction of the court. the court found no systemic violations system-wide that would have compelled district court intervention.25 in light of the documented inadequacies of the v a's claims adjudica­ tion system and the harm it causes the veterans of our nation, this note will examine the decision of the northern district of california federal court regarding the constitutional challenge of denial of due process. specifical­ ly, this note will address why judicial intervention is not precluded, but will suggest how the va can make necessary changes without such intervention. part ii of this note will discuss ptsd and its effects on veterans, and inevit­ ably, society. part ii will also provide an overview ofthe va's claims ad20. see generally compensation and pension benefits page, u.s. dep't of veterans affairs, http://www.vba.va.gov/bln/2l/index.htm (last visited march 8, 2009) (providing general information regarding scddc for veterans). 21. fairweather, supra note 18, at 4. 22. see invismle wounds of war. supra note 2, at 439. 23. peake, 563 f. supp. 2d at 1077. 24. ld. at 1078. 25. id. at 1055. 2010] saving money, not lives 161 judi cation system and the length of time it takes for veterans to receive their benefits. part m will provide an analysis of why judicial intervention is not precluded from providing relief to the veterans' claims of denial of constitu­ tional due process. facial constitutional challenges to the va are allowed, not only through the fifth amendment, but also through the administrative procedure act ("apa"). finally, part iv will examine recommendations as to how the va can implement cost-effective changes that will immediately benefit veterans affected with ptsd, thus averting the proposed judicial intervention. ll.background a. ptsd: clinical presentation, short-term, and long-term effects ptsd did not officially exist until 1980, when the american psychia­ tric association task force revised the diagnostic and statistical manual of mental disorders ("dsm") and entered ptsd in the 1980 dsm-id.26 ptsd moved from being designated a "syndrome" to being designated a "disorder." a syndrome is defined as "a group of signs and symptoms that together are characteristic or indicative of a specific disease or other dis­ order.'m a disorder is an illness. "ptsd changed from being part of a col­ lective indicator to a singular illness, a significant medical distinction.'.28 ptsd is described as occurring when the following criteria are met: a. the person has been exposed to a traumatic event in which both of the following were present: (1) the person experienced, witnessed, or was con­ fronted with an event or events that involved actual or threatened death or serious injury, or a threat to the physical integrity of self (i.e. combat, friendly fire, being mortared or rocketed, wounded, captured, driving a truck on a mined road, flying in a helicop­ ter that was shot at, jumping out of a helicopter into a hot lz) or others (if you had a buddy who was wounded or lost squad members, family member, or seeing anyone who has recently been killed or in26. carol cruzan morton, p'isd: the suffering continues for vets, focus online, http://focus.hms.harvard.edu/2008/032108/public_health.shtml (last visited october 18, 2008). 27. msn encarta dictionary, http://encarta.msn.com/dictionary_l86171 7757/syndrome.html (last visited july 21, 2009). 28. i.s. parrish, military veterans ptsd reference manual 3 (infinity publish­ ing.com 2008) (200 i). 162 indiana health law review jured such as being a . medic or nurse on a trauma ward, body bagging, seeing someone you didn't know killed; seeing kids, women or other americans or civilians who had been killed, or wounded, etc.)[,] (2) the person's response involved intense fear, hel­ plessness or horror. 29 b. the traumatic event is persistently re­ experienced in one (or more) of the following ways: (1) recurrent and intrusive distressing recollections of the event, including images, thoughts, or percep­ tions[;] (2) recurrent distressing dreams of the event[;] (3) acting or feeling as if the traumatic event were recurring (includes a sense of reliving the ex­ perience, illusions,. hallucinations, and dissociative flashback episodes, including those that occur on awakening or when intoxicated)[;] (4) intense psy­ chological distress at exposure to internal or external cues . that symbolize or resemble an aspect of the traumatic event[;] (5) physiological reactivity on ex­ posure to internal or external cues that symbolize or resemble an aspect of the traumatic event. 30 c. persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness (not present before the trauma).31 d. persistent symptoms of increased arousal (not present before the trauma).32 [vol. 7:157 29. id (quoting, with references to children excluded, "from the diagnostic and sta­ tistical manual of mental disorders. fourth edition (dsm-iv), washington, d.c., american psychiatric association, 1994, section 309.81, beginning on page 427 with supplemental information, in parentheses . . . , from the post-traumatic gazette, edited by mrs. patience mason''). 30. id at 3-4. 31. id at 4 (going on to say that this is evidenced by at least three of the following: (1) efforts to avoid thoughts, feelings or conversations associated with the trauma ... [;] (2) efforts to avoid activities, places, or people that arouse recollections of the trauma ... [;] (3) inability to recall an impor­ tant aspect of the trauma ... [;] (4) markedly diminished interest or par­ ticipation in significant activities ... [;] (5) feelings of detachment or estrangement from others ... [;] (6) restricted range of affect ... [;] (7) sense of a foreshortened future ... ). 32. id at 4-5 (going on to say that this is evidenced by at least two of the following: (1) difficulty falling or staying asleep; (2) irritability or outbursts of an­ ger; (3) difficulty concentrating ... [;] (4) hypervigilance) always look­ ing for danger, worrying about people getting hurt, still looking for tripwires and sitting with your back to the wall, avoiding crowds, etc.); 2010] sa vlng money, not lives e. duration of the disturbance (symptoms in crite­ ria b, c, and d) is more than [one] m:onth.33 f. the disturbance causes clinically significant dis­ tress or impairment in social, occupational, or other important areas of functioning. 34 163 by simply reading the lengthy, complex criteria to diagnose ptsd, it is easy to conclude that diagnosing ptsd requires that veterans have access to qualified mental health professionals. research has shown that the majority of persons "in whom ptsd develops meet the criteria for the diagnosis of this disorder within the first three months after the traumatic event. "35 it would seem, then, that veterans not only need access to qualified mental health professionals, but they need that access in a timely manner: within the first three months of experiencing the triggering traumatic event. patients diagnosed with ptsd have to deal with both short-term and long-term effects. the brains of patients under the stress that accompanies ptsd might have a more difficult time healing, and there are major neuro­ biological consequences to ptsd.36 some problems that ptsd patients experience include clear problems with attention, working memory, learn­ ing, and executive functioning. insomnia, depression and irritability are other overlapping symptoms. 37 due to the nature of the symptoms experienced· by those diagnosed with ptsd, those affected tend to miss more days of work, report being less productive while at work, and are more likely to be unemployed. 38 in addi­ tion, "[p]sychiatric illnesses appear to predict homelessness.'o39 further­ more, those affected with ptsd suffer in their interpersonal relationships, leading to disrupted marriages, interference with parenting, and ultimately problems can arise in the children of those affected with ptsd that "extend the costs of combat experiences across generations. "40 no statement portrays the plight of the diagnosed ptsd patient better than the following: "the effects of a post-combat mental health [condition] can be compared to ripples spreading outward on a pond. but whereas rip­ ples diminish over time, the consequences of mental health and cognitive conditions may grow more severe, especially if left untreated."41 these are (5) exaggerated startle response (hit the dirt at the sound of a backfire, can't be touched when asleep, etc.). 33. !d. at5. 34. parrish, supra note 28, at 5. 35. charles w. hoge et al., combat duty in iraq and afghanistan, mental health problems, and barriers to care, 351 new eng. j. med. 13, 20 (2004) (citation omitted). 36. stephen spotswood, like ptsd/i'bi symptoms complicate treatment, 44 u.s. medicine, sept. 2008, at 17. 37. !d .. 38. invlsmlewoundsofwar,supranote2,at 149. 39. !d. 40. !d. 41. !d. 164 indiana health law review [vol. 7:157 documented effects occurring in the diagnosed ptsd veteran. the problem is that many veterans do not even get the "benefit" of a diagnosis of ptsd, even when that diagnosis is clearly warranted. without the diagnosis, there can be no treatment for these veterans. although some have attempted to document the direct medical cost of treatment ofptsd,42 direct medical costs of treatment represent only a frac­ tion of the total costs related to the injuries sustained by the ptsd patient. "lndjrect, long-term individual and societal costs stem from lost productivi­ ty, reduced quality of life, homelessness, domestic violence, the strain on families, and suicide.'.43 ptsd is not a new phenomenon for our veterans. ''nearly one in five vietnam veterans suffered ... (ptsd) and nearly one in 10 was still suf­ fering 11 to 12 years after the war .'.44 today, the average age of a united states soldier serving in iraq/ mghanistan is thirty years old. knowing that leaving ptsd untreated can lead to years of suffering and impactful societ­ al costs, the nation faces serious implications if the~ veterans continue to be denied access to statutorily-mandated benefits which would, in turn, give them access to evidence-based care. b. va claims adjudication system: an overview oetting a medical diagnosis, and subsequent medical treatment, for ptsd is only one obstacle a veteran faces when dealing with the va after discharge from active duty. veterans are having a difficult time compelling the va to make timely determinations on requests for disability benefits. as previously mentioned, levels of disability and corresponding monetary benefits for veterans are based on service-connected ratings, and the benefit is referred to as scddc.45 disabilities can include those associated with emotional injuries, such as ptsd. in order "(t]o establish a claim for scddc, a veteran must present evidence of{1) a disability; {2) service in the military that would entitle him or her to benefits; and {3) a nexus between the disability and the service.'.46 · the initial claims procedure is extremely complicated, beginning with a daunting twenty-three page form. complications in completing the re­ quired form include strict technical requirements which if missed may dis­ qualify the claim regardless of its underlying merit. 47 "veterans often make . 42. see invisffile wounds of war, supra note 2, at xxiii. 43. !d. at8. 44. sean alfano, fewer vietnam veu &dferfomrpisd; but study shows post-traumatic stress levels still quite high, cbs news, aug. 17, 2006, htlp:/lwww.cbsnews.com/storiesl 2006/08/171health/webmdlmainl908799.shtml (last visited july 21, 2009). 45. see generally compensation and pension benefits page, supra note 20. 46. peake, 563 f. supp. 2d at 1070. 47. peake, 563 f. supp. 2d at 1071. see also http://www.wanns.vba.vagov/regs/ 38cfribookb/supple-b-66.doc, for an example of a "supplement" to filing for service 2010] saving money, not lives 165 mistakes when completing this application and veterans suffering from ptsd have a particularly hatd time ... .'.48 it is no surprise that many first time attempts by veterans with ptsd to complete these forms result in de­ nials or inappropriately low scddc ratings. 49 the enormity of the impact of the claims adjudication process begins to unfold when the statistics are laid bare. it takes an average of 183 days for a veteran to receive an initial deci­ sion based upon his filing for scddc; after which a notice ofdisagreement may be filed. 50 veterans pursuing a claim for ptsd have an additional burden of proving a "stressor" event during their service~ this makes the claim more complex to adjudicate, and so the length of time to adjudicate these claims is increased. 51 a veteran who has been denied scddc does have the opportunity to appeal the denial, though he will be without compensation during the time that he is waiting for his appeal to be decided. an adverse claims decision can be appealed to the board of veterans appeals (bva).52 it is notewor­ thy to remember that veterans experiencing symptoms of ptsd, whether they have had the good fortune to be diagnosed or not, may be experiencing the short-term effects of the disease state mentioned previously while they wait for a decision from the bva. thus while waiting for the bva's deci­ sion, a veteran may be homeless, jobless, and experiencing severe depres­ sion. this becomes startling when looking at the next set of statistics. after filing the initial twenty-three page form, receiving a denial, and filing a notice of disagreement, it takes the va, on average, 261 days to mail a veteran a statement of the case.53 subsequently, it takes the veteran approximately forty-three days to file a required form 9 substantive appeal based on the statement of the case. 54 after receiving a form 9 appeal from the veteran, it then takes the va another 573 days after receiving the veter­ an's form 9 to certify the appea1.55 some veterans' have had to wait more than 1,000 days to get this certification.56 the veteran then has the pleasure of waiting yet another 336 days, oil average, for a decision to be rendered on his appeal. 57 bottom line: it takes, on average, 4a years for a veteran to adjudicate a claim all the way through the appeals process, excluding the time the veteran had to wait for the initial denial ofbenefits.58 connected benefits. 48. peake, 563 f. supp. 2d at 1071. 49. fairweather, supra note 18, at 4. 50. peake, 563 f. supp. 2d at 1070-72. 51. /d. at 1070. see also 38 c.f .r. § 3.304 (2008) (outlining the specific requirements for a veteran to substantiate service-connected disabilities). 52. peake, 563 f. supp. 2d at 1072. 53. jd. at 1073. 54. jd. 55. jd. 56. jd. 57. jd. at 1074. 58. peake, 563 f. supp. 2d at 1073-74. 166 indiana health law review [vol. 7:157 even more startling is the fact that a veteran cannot pay for counsel to represent him during the initial phases of the claims adjudication process. although a veteran may be represented throughout the claims adjudication process at the regional office ("ro"), the veteran is statutorily prohibited from compensating a lawyer to represent him at the ro level. 59 this is not to say that a veteran is left completely out in the cold: he can be assisted by attorneys acting pro bono or by veteran service organizations (''vs0").60 even so, as noted by the court in veterans for common sense v. peake, the va does not provide training on how to assist the veteran and "all of the vsos combined cannot meet the. needs of all the veterans seeking bene­ fits.'.61 as previously mentioned, veterans often make mistakes when com­ pleting the initial claim for scddc, and veterans suffering from ptsd are particularly susceptible to difficulty in completing the form. "repairing a poorly crafted claim is difficult and time consuming and can leave the vet­ eran without proper compensation for years. ,,62 although veterans are now able to hire an attorney to assist with their claims on appeal, few attorneys have any level of expertise in the area of va claims.63 it follows, then, that without the ability to consult competent counsel or trained-vso representa­ tives, a veteran is left to flounder along helplessly while his fate is left in the hands of the va claims adjudication process: a process that takes, on average, 4.4 years to complete. no other claims adjudication process even remotely approaches the time frame of the va claims adjudication system. the private sector health care/financial services industry, which processes thirty billion claims an­ nually, averages 89.5 days per claim, including the time required for resolu­ tion of disputed claims. 64 "between october 1, 2007, and march 31, 2008, alone, at least 1,467 veterans died during the pendency of their appeals. when an appellant dies, the appeal is extinguished .• .6s there is no doubt that the veterans' advocacy groups' lawsuit was necessary to bring national attention to the shameful denial of benefits to our nation's veterans. by asking the court to intervene, as is statutorily and. constitutionally allowed, the lawsuit just may force the va to make the necessary changes to provide the nation's veterans with their mandated benefits: without judicial inter59. peake, 563 f. supp. 2d at 1072, see also 38 u.s.c. §5904 (2007) (outlining the guidelines provided by congress for attorney compensation). · 60. peake, 563 f. supp. 2d at 1072. 61. !d. (citation omitted). 62. fairweather, supra note 18, at 5. 63. id. 64. linda bilmes, soldiers returning from iraq and afghanistan: the long-term costs of providing medical care and disability benefits at 8 (2007) (unpublished research paper, on file with harvard university kennedy school of government), available at hup:/lksgnotes1.harvard.eduiresearcblwp.nst7rwpirwp07-0011$filelrwp_07_001_bilmes.pdf. 65. peake, 563 f. supp. 2d at 1075. 2010] saving money, not lnes 167 vention. iii. analysis: federal district courts doha ve the power to grant a remedy a. facial constitutional challenges to va allowed the veteran's judicial review act ("vjra") contains statutory pro­ visions that preclude review of various challenges to the va in federal dis­ trict courts.66 but the vjra does not strip district courts of the ability to hear facial constitutional challenges to the va benefits system.67 in addi­ tion, under the administrative procedure act, a district court shall "compel agency action unlawfully withheld or unreasonably delayed. "68 even the court of veterans' appeals ("cv a") held that federal district courts pro­ vided an alternative forum to the va system to litigate constitutional chal­ lenges stating: a claim which alleges only the unconstitutionality of a statute is not a claim "under a law that affects the provision of benefits by the secretary" under § 511 (a), but rather is a claim under the constitution of the united states. as such, it is beyond the purview of section 511 (a). nothing in title 38 prohibits a con­ stitutional challenge to any of the provisions of that title from being litigated in u.s. district court.69 in order for the claim to move forward, the advocacy groups needed to es­ tablish standing and a waiver of sovereign immunity by the va. 1. establishment of standing although the va attempted to argue that the advocacy groups did not have standing to bring the lawsuit before the district court, judge conti ruled otherwise.70 an association has standing to bring suit on behalf of its members when its members would otherwise have standing to sue in their own right, the interests at 66. veterans' judicial review act ("vjra"), pub. l. no. 100-687 (1988); 38 u.s.c. §§ 7251-7298 (2000). 67. 38 u.s.c. §§ 511, 1975 (1994). 68. 5 u.s.c. § 706(1) (1993). 69. dacoron v. brown, 4 vet. app. 115, 119 (vet. app. 1993). 70. peake, 563 f. supp. 2d at 1056. 168 indiana health law review stake are germane to the organization's purpose, and neither the claim asserted nor the relief requested re­ quires the participation of individual members in the lawsuit.71 [vol. 7:157 the court also found that the veterans' advocacy groups demonstrated that the significant delays in receiving medical care and disability benefits from the va did indeed satisfy the element of suffering injuries in fact. 72 in fact, the court acknowledged the severity of the injury, stating the injuries suffered by the veterans affected were anything but conjectural or hypothet­ ical "given the dire consequences many of these veterans face without time­ ly receipt of benefits or prompt treatment for medical conditions, especially ... ptsd.'m "delays in health care, especially for mental health issues, and delays in receipt of disability benefits, which are often the primary or sole source of income for a veteran, can lead to exactly the type of injuries complained of by plaintiffs.''74 thus, a causal connection between the injuries suffered and the va' s conduct in question, established the second element needed for standing. finally, the court acknowledged that the injunctive and declaratory re­ lief sought by the advocacy groups would likely result in redressing the vet­ erans' injuries. 7s although the court eventually held that it was not within the power of the court to actually grant the requested relief; the plaintiffs' established all the necessary elements for standing. 76 2. establishment ofwaiverofsovereign immunity by the va standing is not the only matter the advocacy groups needed to estab­ lish for a district court to hear their complaint against the va. "the united 71. /d. at 1056 (citing friends of the earth. inc. v. laidlaw envtl. servs., inc., 528 u.s. 167, 181 (2000). see also lujan v. defenders ofw'lldlife, 504 u.s. 555, 560-61 (ex­ plaining the three elements a member would need to establish to sue in his own right: first, the plaintiff must have suffered an "injury in fact" an invasion of a legally protected interest which is (a) concrete and particularized and (b) "actual or imminent, not 'conjectural' or 'hypothetical.' second, there must be a causal connection between the injury and the conduct complained ofthe injury has to be "fuirly ... trace[able] to the chal­ lenged action of the defendant, and not ... the result [of] the indepen­ dent action of some third party not before the court." third, it must be "likely," as opposed to merely "speculative," that the injury will be "re­ dressed by a favorable decision. (citations omitted)). 72. peake, 563 f. supp. 2d at 1077. 73. /d. 74. /d. 75. /d. 76. /d. 2010] saving money, not lives 169 states must waive its sovereign immunity before a federal court may adju­ dicate a claim brought against a federal agency.'m despite the fact that the northern district of california federal court found in a preliminary decision that the advocacy groups had "sufficiently alleged various challenges to 'final agency actions' ,"78 the court reversed its previous finding stating that the advocacy groups failed to challenge a final agency action. 79 the administrative procedure act ("apa"), 5 u.s.c. §§ 701-706, is the relevant statute for determining whether a valid waiver of sovereign immunity exists. section 702 of the ap a states, in part: an action in a court of the united states seeking relief other than monetary damages and stating a claim that an agency or an officer or employee thereof acted or failed to act in an official capacity or under color of legal authority shall not be dismissed nor relief there­ in be denied on the ground that it is against the united states .... 80 section 704 of the apa states, in part, that only "[a]gency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court, are subject to judicial review.'.s1 there­ fore, the advocacy groups needed to establish: 1) that a final agency action had taken place on the part of the va, and 2) that the veterans had no other adequate remedy in a court in order for the district court to provide judicial review based on a waiver of sovereign immunity. the northern district of california federal court in veterans for common sense v. peake correctly held that the va benefits system for ad­ judicating veterans individual benefit claims does not provide an adequate alternative remedy for the limited purpose of plaintiffs' systemic, facial constitutional challenges.82 the court incorrectly deduced, however, that the plaintiffs failed to challenge a final agency action, reversing its previous decision. 83 in the alternative, the court did not take into consideration that "[r]eview of an agency's failure to act has been referred to as an exception 77. peake, 563 f. supp. 2d at 1056 (citing rattlesnake coalition v. u.s. epa, 509 f.3d 1095, 1103 (9th cir. 2007)). 78. veterans for common sense v. nicholson, no. c-07-3758 sc, 2008 u.s. dist. lexis 4540, at *19 (n.d. cal. jan. 10, 2008). 79. peake, 563 f. supp. 2d at 1078. 80. 5 u.s.c.a. § 702 (current through p.l. 111-4 approved 2009). see also gallo cattle co. v. dep't of agric., 159 f.3d 1194, 1198 (9th cir. 1998)(stating that the apa "does provide a waiver of sovereign immunity in suits seeking judicial review of a federal agency action under [28 u.s.c.] § 1331"). 81. 5 u.s.c. § 704 (1993). 82. peake, 563 f. supp. 2d at 1079. 83. nicholson, supra note 78, at *19. 170 indiana health law review [vol. 7:157 to the final agency action requirement. ,,84 a. final agency action agency action is defined as "the whole or a part of an agency rule, or­ der, license, sanction, relief, or the equivalent or denial thereof, or failure to act."85 the district court addressed the veterans concerns in its preliminary decision and stated that the veterans' challenges to aspects of the vjra are "rightfully considered final agency action as they constitute the va's denial of relief of health care and benefits."86 the court went on to say that "the summary and allegedly premature denial of ptsd claims ... result in alle­ gedly unlawful denial of benefits ... [and such] .•. policies and procedures fall within the broad statutory definition of 'final agency action' .'.s7 nonetheless, in the court's final decision, rendered just five months later, the court stated that the advocacy groups' challenges failed "for other reasons, including failure to challenge a final agency action, failure to chal­ lenge a discrete agency action, and/or failure to challenge an action that the agency is required to tak:e.~'88 nowhere in its opinion does the court actual­ ly give a reason for this determination. in fact~ the court simply states that 38 u.s.c. § 511 prevents the court from undertaking a review of the unrea­ sonable delay in claims adjudication as such a review would depend on the facts of each particular claim, and such a review is barred by § 511.89 the district court did, however, acknowledge that the supreme court, in norton v. s. utah wilderness alliance, stated that "[i]t is uncontested the adjudication of benefits claims is a discrete agency action that the va is required to tak:e.''90 given the statistics outlined previously, it would appear that an average adjudication time for veterans' appeals of benefits decisions approaching 4.4 years would qualify as the va's failure to act on a discrete agency action that the va is required to take. forays into individual claims are not required to resolve the challenges to delays across the adjudication system. the only connection that systemic delay has to individual veterans is the fact that the average is an aggregate of the underlying claim processing times. thus, 38 u.s.c. § 511 would not bar the district court from review. the district court subsequently undertook an analysis to support its decision denying the veterans relief despite its statement that the advocacy 84. ctr. for biological diversity et al. v. abraham, 218 f. supp. 2d 1143, 1157 (n.d. cal. 2002). 85. 5 u.s.c. § 551(13) (1966) (emphasis added). 86. nicholson, supra note 78, at *17. 87. /d. 88. peake, 563 f. supp. 2d at 1078. 89. /d. at 1083-84. 90. id (citing norton v. s. utah wilderness alliance, 542 u.s. 55, 64, 124 s. ct. 2373, 159 l. ed. 2d, 137 (2004)). 2010] saving money, not lives 171 groups failed to challenge a discrete agency action and/or failed to chal­ lenge a final agency action.91 the court did not undertake an analysis as to whether the va's significant delays in scddc claims adjudication consti­ tuted a failure to act, which would constitute an exception to the final agen­ cy act requirement. given the statistical evidence presented and the lack of explanation as to why the court changed its position, one can conclude that the advocacy groups did, indeed, challenge final agency action. b. no other alternate adequate remedy in addition to the requirement of challenging a final agency action, the advocacy groups had to show that there was no other adequate alternative remedy in a court.92 the district court ultimately found that ''the va bene­ fits system is not an adequate alternate forum for [p ]laintiffs' systemic and facial constitutional challenges. "93 because the veterans' advocacy groups could arguably establish both elements to show a waiver of sovereign immunity on the part of the va, and standing for the groups was clearly established, the district court's re­ view of the delay in the va's claims adjudication process was warranted, despite the court's statement that it was precluded from such a review. the court, notwithstanding its proclamation that review was beyond its purview, still went through an analysis of the va's claims adjudication system. in undertaking this analysis the court looked to the ap a, applicable congres­ sional statutes, and the fifth amendment of the constitution in an effort to assess whether veterans are being denied due process caused by unreasona­ ble delay in benefit claims adjudication. b. applicable law: administrative procedure act (apa), congressional statutes, fifth amendment to the united states constitution various statutes admonish the va to adjudicate benefits, claims, and appeals in a timely manner.94 the apa entitles veterans to injunctive relief to remedy the va's "unreasonable delays." section 706(1) of the apa permits federal courts to compel agency action unlawfully withheld or un91. peake, 563 f. supp. 2d at 1083-89. 92. 5 u.s.c. § 704 (1993). 93. peake, 563 f. supp. 2d at 1079. 94. see, e.g., 38 u.s.c. § 7101 (1994) (imposing a statutory duty to hire sufficient personnel to process appeals at the bva in a timely manner); 38 u.s.c. § 5109b (1994) (imposing a statutory duty to resolve remands in an expeditious manner); 38 u.s.c. § 1705 (1994) (imposing a statutory duty to ensure that the system will be managed in a manner to ensure that the provision of care to enrollees is timely and acceptable in quality); 5 u.s.c. § 706(1) (1993) (stating that a reviewing court shall compel agency action unlawfully withheld or unreasonably delayed). 172 indiana health law review [vol. 7:157 reasonably delayed.95 the united states court of appeals for the district of columbia circuit in telecommunications research and action center (trac) v. federal com11111nications commission (fcc) decided that courts designated by statute to review agency action should do so when the agency has improperly withheld or unreasonably delayed action it is required to take.96 the court went on to state that although no single test had yet been articulated to detennine whether an agency had unreasonably delayed ac­ tion, one could discern ''the hexagonal contours of a standard. "97 these hexagonal contours include the following six factors to assess claims of agency delay: ( 1) the time agencies take to make decisions must be governed by a "rule of reason" ... ; (2) where con­ gress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason ... ; (3) delays that might be reasonable in the sphere of economic regulation are less tolerable when human health and welfare are at stake ... ; ( 4) the court should consider the effect of expediting delayed action on agency ac­ tivities of a higher or competing priority ... ; (5) the court should also take into account the nature and ex­ tent of the interests prejudiced by delay ... ; and ( 6) the court need not "find any impropriety lurking be­ hind agency lassitude in order to hold that agency ac­ tion is 'unreasonably delayed.'"98 these factors have since become known as the tra c factors and have been used by subsequent courts to assess whether an agency's actions have been unreasonably delayed.99 the court in veterans for common sense v. peake undertook an analysis of the v a's actions, using the trac factors, to determine if unreasonable delay existed in the adjudication of benefit claims for veterans, even though it had stated that it had no authority to rule on such an issue.100 the court subsequently held that an analysis using the tra c factors did not "favor a finding that the delays in the va claims ad95. 5 u.s.c. § 706(1) (1993). 96. telecomm. research and action ctr. v. fed. commc'ns comm'n, 750 f.2d 70, 76 (u.s. app. d.c. 1984). 97. ld at80. 98. ld (citations omitted). 99. see, e.g., independence mining co. v. babbitt, 105 f.3d 502,507 (9th cir. 1997). 100. seepeake, 563 f. supp.2dat 1084-85. 2010] saving money, not lives 173 judication system are unreasonable."101 apart from the claim under ap a, the veterans' advocacy groups brought a constitutional claim challenging that the delays and waiting times for veterans filing scddc claims and/or appeals were '"so lengthy as to constitute an unconstitutional deprivation of property under the due process clause"' of the fifth amendment. 102 it has been well established that the veterans have a property interest in their benefits, as the benefits are statutorily-mandated. "claimants who satisfy the statutory criteria for eli­ gibility are entitled as a matter of law to scddc benefits. based on the statutory framework, many veterans have a protected property interest as applicants for and recipients of scddc benefits."103 substantial delays in adjudicating claims for disability benefits can, in and of themselves, violate the due process clause. 104 in evaluating whether a procedure satisfies due process, courts balance (1) the private interest, (2) the risk of erroneous deprivation and the probable value, if any, of addition­ al safeguards, and (3) the government's interest, "including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirement would entail."105 the veterans' advocacy groups charged violation of due process as ''there is no opportunity for any hearing by a neutral decision-maker, the process is unduly complicated and lengthy, and there is no provision for any expedited process that would ap­ ply in an emergency situation such as a threatened suicide."106 in veterans for common sense v. peake, the district court did not even undergo an analysis of the required three-part balancing test outlined in ma­ thews v. eldridge in order to determine if a due process claim applied to the veterans. the district court devoted only a single paragraph to summarily reject the veterans' due process claims.107 the court cited wright v. califa­ no, a case involving benefit dispensation by the social security administra­ tion, stating that the holding in wright was "illuminating."108 it is important 101. /d. at 1085. 1 02. /d. (quoting plaintiff's proposed order page 7). 103. peake, 563 f. supp. 2d at 1086. 104. see, e.g., rodrigues v. donovan, 769 f.2d 1344, 1348 (9th cir. 1985) (stating that due process claim based on considerable delay in deciding right to disability benefits found not insubstantial); andjugar v. weinberger, 69 f.rd. 690,694 (s.d.n.y. 1976) (stating that "[d]elays themselves may result in a deprivation of property."); kraebel v. new york city dep't. ofhous. preservation and dev., 959 f.2d 395,405 (2d cir. 1992) (stating that "delay in processing can become so unreasonable as to deny due process."). 105. mathews v. eldridge, 424 u.s. 319, 335, 96 s. ct. 893,47 l. ed. 2d 18 (1976). 106. peake, 563 f. supp. 2d at 1082. 107. ld at 1086. 108. id (quoting wright v. califano, 587 f.2d 345, 356 (7th cir. 1978). the wright court stated that although judicial intervention may be required at some point, the solu­ tion must come from the ssa itself with the assistance of congress. to impose on the ssa the crash review program sought by plaintiffs could 174 indiana health law review [vol. 7:157 to note here that the district court also cited yet another case which held that it would be rare for a court to intervene when the passage of time, and noth­ ing more, presented an occasion for the court to intervene in an agency's adjudicative proceedings. 109 it is also important to note the link between the delays in the veterans' access to mental health care for ptsd and the delays in adjudication for scddc benefit claims. as mentioned previously, the district court found that many disability compensation recipients are totally or primarily depen­ dent upon their statutorily-mandated scddc benefits for financial support. 38 u.s.c. § 1710 provides that the secretary shall furnish medical services determined to be needed to any veteran for a service-connected disability for a five-year period. 110 the district court found that this language created an entitlement to health care for veterans for five years after separation from active duty. 111 the district court found that the evidence presented did not show that there was a "system-wide crisis" in which health care was not being provided within a reasonable time. 112 although the passage of 4.4 years to adjudicate a contested scddc benefit claim in itself is appalling, the fact that 1,000 veterans a month are attempting or succeeding in committing suicide, some simply waiting for the claims adjudication process to be completed to grant them their property right of benefit payouts. this certainly warrants more attention from the district court than a single paragraph. and the case the veterans put forth via the advocacy groups show, without a doubt, that there is more to the story than simply "the passage of time, and nothing more." without access to the appropriate diagnosis and treatment for the disease state of ptsd, coupled with the denial of statutorily-mandated scddc benefits for some veterans to the tune of 4.4 years, these veterans are in desperate need of help: and the district court has it in its power to deliver that help. this law­ suit is that cry for help. c. application oftrac factor analysis and due process analysis to the va 's claims atfjudication process 1. trac factor analysis again, section 706(1) of the apa permits federal courts to compel agency action unlawfully withheld or unreasonably delayed. 113 the district be expected to result in a deterioration of the quality of the review, and possibly more injustice to claimants than justice. 109. peake, 563 f. supp. 2d at 1086 (quoting the holding offed'l trade comm'n v. weingarten, 336 f.2d 687, 692 (5th cir. 1964)). 110. 38 u.s.c. § 1710 (1994). 111. peake, 563 f. supp. 2d at 1079. 112. id. at 1081. 113. 5 u.s.c. § 706(1) (1993). 2010] saving money;, not lives 175 court undertook a trac factor analysis in regards to the va's claims adju­ dication process and concluded that "[a]lthough the delays faced by veter­ ans, especially during the appeals process, are significant, the tra c factors militate against a finding ofunreasonableness."114 it is noteworthy that the trac factors impose a rule. of reason with re­ spect to agency delay and take into account the consequences to health and human welfare, balanced by the imposition of complying with timeliness of agency action upon the agency. the first and second trac factors specifi­ cally address the rule of reason and whether congress ·has mandated any timetables or indications that infonn of a rule of reason. 115 the district court concluded that these frrst two factors favored "neither a finding of reasonableness nor unreasonableness" because the applicable statutory scheme lacked any fixed time limits, thus rendering the veterans'claims of entitlement to relief under the ap a for the delays in claims adjudication without merit.116 the court deduced further that this holding was "rein­ forced by the fact that congress specifically did not include any fixed time limits for the adjudication of veterans benefit clai:rps."117 yet, the entire purpose of the tra c factors is to evaluate whether de­ lay is unreasonable in the absence of such defined deadlines. us thus, the first tra c factor supplies courts with a ''rule of reason" standard by which agency delay can be assessed absent an explicitly-defined deadline. when looking at the statistics put forth by the veterans' advocacy groups, and supported by the va' s own data, it is difficult to believe that a 4.4 year ad­ judication time-frame for any scddc claim is "reasonable" under a "rule of reason" standard. in fact, this time frame becomes even more ''unreasonable" when compared to the private sector health care/financial services industry. this industry processes an annual thirty billion claims in an average of 89.5 days per claim, which includes the time required for claims that are disputed.119 it is interesting to note that the united states government accountability office ("gao") has published several statements admonishing the va's claims processing performance; and these admonishments span nearly a decade.120 114. peake, 563 f. supp. 2d at 1084. 115. telecomm. research and action ctr., 750 f.2d at 79. 116. peake, 563 f. supp. 2d at 1084. 117. id. 118. forest guardians v. babbit. 174 f.3d 1178, 1191 n. 19 (loth cir. 1998) (stating that trac factor analysis only applies in the absence of any statutorily defined mandatory deadlines). 119. bilmes, supra note 64, at 7. 120. see, e.g., u.s. govr. accountability office, veterans' benefits: processing encouraging, but challenges still remain (1999); u.s. govr. accountability office, veterans' benefits: quality assurance for disability claims and appeals processing can be further improved (2002); u. s. govr. accountability office, veterans' disability benefits: long-standing claims processing challenges 176 indiana health law review [vol. 7:157 the district court belittled this statistic by emphasizing that only four to eleven percent of veterans who pursue appeals would face lessened de­ lays should the va be forced to adjudicate these claims in a timely, or rea­ sonable, manner.121 what the district court failed to address is the fact that among that four to eleven percent are veterans who are suffering from ptsd, whether they have been diagnosed or not. the stress caused by struggling with va bureaucracy exacerbates the already overwhelming symptoms of ptsd, and these veterans are left without a means to survive until their claims are finally adjudicated, or until they simply cannot wait any longer and attempt to adjudicate the situation in their own way: by joining the ever-growing ranks of veterans attempting suicide at the rate of 1,000 per month. the district court could have looked to the va' s own pilot program for expedited claims adjudication to provide content to the rule of reason under the second tra c factor. 122 this pilot program asks participating ro' s to certify appeals to the bv a within thirty days of receipt of a form 9 appeal.123 if the va itself recognizes that a problem with claims adjudica­ tion exists to the point that a pilot program is needed to test the viability of expediting the claims adjudication process, then surely the district court could have acknowledged the same. allowing that the first and second trac factors impose a rule of rea­ son upon the va for adjudicating claims in a reasonable manner, and that the tra c factors exist to evaluate whether delay is unreasonable in the ab­ sence of any defined deadlines, the evidence weighs heavily in favor of the veterans for these first two trac factors. the district court's conclusion that these first two trac factors favored neither a finding of reasonable­ ness nor unreasonableness simply does not ring true when applying the ac­ tual timeliness of the va's claims adjudication timeframe for claims that must make their way through the entire appeals process. delays of over four years are unacceptable under any rule of reason, especially when compared to the private sector's average of 89.5 days per claim, which includes the time needed to adjudicate disputed claims. the district court found that analysis under the third, fifth and sixth trac factors also weighed heavily in the veterans' favor. 124 the court stated that it was beyond "dispute that the health and welfare of veterans was at stake," 125 which directly addressed the third trac factor. the court persist(2007) [hereinafter gao longstanding claims];); u. s. govt. accountability office, veterans' disability benefits: processing of claims continues to present challenges (2007) [hereinafter gao processing of claims]. 121. peake, 563 f. supp. 2d at 1085. 122. board of veterans' appeals: expedited claims adjudication initiative-pilot pro­ gram, 73 fed. reg. 20571 (proposed april16, 2008) (to be codified at 38 c.f.r. pts. 3 and 20). 123. !d. 124. peake, 563 f. supp. 2d 1085. 125. !d. (reiterating that the third trag factor declares that delays that might be reason2010] saving money, not lives 177 addressed the fifth trac factor by stating that the "nature and extent of the interests prejudiced by the delay could not be any more serious.'~126 finally, the court found that the sixth trac factor, in which a finding of unreasona­ ble delay need not be based on impropriety on the part of an agency, fa­ vored relief for the veterans. 127 nevertheless, the court went on to state that when applying the trac factor analysis, the weight of all other factors, including the factor stating that delays affecting human health and welfare are less tolerable than those in the sphere of economic regulation, did not "overcome the fourth factor, which states that the court should consider the effect of expediting delayed action on agency activities of a higher or competing priority."128 the only justification that the court offered in finding that the fourth trac factor outweighed all the overwhelming evidence in favor of the veterans was that only four percent "of the total claims are actually pursued to a decision by the bva.''129 the court mentioned congress' continuing concern that man­ datory deadlines would subordinate quality to timeliness,130 and that com­ peting agency priorities precluded relief. be that as it may, the va never argued that implementing a more rea­ sonable, timely adjudication of appealed claims would compromise the timeliness of claims adjudication at the initial ro level. nor did the va argue that decreasing the time to adjudicate appealed claims would subordi­ nate quality to timeliness; neither for claims at the ro level, nor for ap­ pealed claims. finally, the va did not offer any competing priorities that would preclude it from adjudicating appealed veterans' claims in a timelier manner. "(e]xtensive or repeated delays are unacceptable notwithstanding competing interests."131 thus, the court's conclusion that lessening the unconscionable delays at the appellate level of claims adjudication would negatively impact the claims adjudication at the ro level is unfounded. likewise, the court's conclusion that factor four of the tra c analysis outweighs all the other factors weighing in favor of the veterans is unjustified. under the ap a, should a court determine that agency action has been unreasonably delayed, the court must compel the agency to act.132 given the fact that delays in the adjudication of veterans' claims have spanned more than a decade, coupled with the fact that the tra c factor analysis able in the sphere of economic regulation are less tolerable when human health and welfare are at stake). 126. peake, 563 f. supp. 2d at 1085. 127. !d. 128. !d. at 1084-85 (quoting independent mining co. v. babbit, 105 f.3d 502, 507 n. 7 (9th cir. 1997)). 129. !d. 130. id at i 084. 131. muwekma tribe v. babbitt, 133 f. supp. 2d 30, 40 (2000 u.s. dist. lexis 22871) 132. 5 u.s.c. § 706(1) (1993). 178 thidmnah~thlawrevmw [vol. 7:157 weighs heavily in the veterans' favor, the district court had within its power to rule that the va had ''unlawfully withheld or unreasonably delayed" benefits to deserving veterans under section· 706(1) of the ap a. thus, the district court should have compelled the va to act pursuant to the statutory mandates set forth by congress.133 2. due process analysis not only do the four-year delays in claims adjudication violate con­ gressional statutory mandates and the ap a requirements, but these delays also constitute a violation of the due process clause. the veterans' advo­ cacy groups contended ''that the delays in adjudicating scddc benefit claims [were] excessive and unreasonable and therefore violate the rights of veterans under ... the due process clause."134 the district court, however, held that although the "delays in benefits claims adjudications, especially for appeals, [were] substantial, the existing statutory framework . . . pre­ vent[ed] this court from taking remedial action"135 and stated "[t]his con­ clusion [was] reinforced by the fact that only 4% of the total claims each year are appealed and pursued to a decision by the bv a."136 the district court did recognize that veterans who satisfy eligibility criteria outlined in the applicable statute are entitled, as a matter of law, to scddc benefits!l7 as such, veterans who qualify have a property interest under the due process clause. nevertheless, the court went on to quote case law supporting its view that a due process violation had not occurred, stating that "' [t]here is no talismanic number of years or months, after which due process is automatically violated "'138 the court continued down this path of reasoning, justifying its decision to not undergo a thorough due process analysis, writing, "'in determining when due process is no longer due process because past due, the influence of other significant circums­ tances is not to be ignored .... delay is a factor but not the only factor. "'139 133. see, e.g., 38 u.s.c. § 710l(a) (1994) (imposing a statutory duty to hire sufficient personnel to process appeals at the board of veterans appeals ("bva") in a timely manner); 38 u.s.c. § 5109b (1994) (imposing a statutory duty to resolve remands in an expeditious manner); 38 u.s.c. § 1705 (1994) (imposing a statutory duty to ensure that the system will be managed in a manner to ensure that the provision of care to enrollees is timely and ac­ ceptable in quality); 5 u.s.c. § 706(1) (1993) (stating that a reviewing court shall compel agency action unlawfully withheld or unreasonably delayed). 134. peake, 563 f. supp. 2d at 1083. 135. /d. 136. /d. 137. /d. at 1086. see also 38 u.s.c. § 1710 (1994) (providing that the secretary shall furnish medical services determined to be needed to any veteran for a service-connected disability for a five-year period). 138. peake, 563 f. supp. 2d at 1086 (quoting coe v. thurman, 922 f.2d 528, 531 (9th cir. 1990)). 139. peake, 563 f.supp.2d at 1086 (quoting wright v. califano, 587 f.2d 345, 354 (7th cir. 1978)). 2010] saving money, not lives 179 the simple passage of time, though, is relevant for veterans being de­ nied their statutorily-mandated benefits: for some suffering from ptsd, it can mean the difference between life and death. with "eighteen u.s. veter­ ans kill[ing] themselves every day ... [more] veterans are committing sui­ cide than are dying in combat overseas."140 indeed, the court's own argument that other significant circumstances are not to be ignored would seem to justify a closer look at how the denial of scddc benefits in a time­ ly manner may, or may not, be a contributing factor in the escalating num­ ber of veteran suicides. as stated previously, delays in adjudicating claims for disability bene­ fits can, without more, violate the due process clause. 141 given that the veterans' advocacy groups firmly established that some veterans, albeit per­ haps only four percent, have waited four years or more for a claims deter­ mination, the district court shirked its duty by not undertaking a thorough due process analysis. had the district court undergone an analysis of the required three-part balancing test outlined in mathews v. eldridge to deter­ mine if a due process claim applied to the veterans being denied scddc benefits, it would have found a due process violation. to reiterate, the mathews v. eldridge balancing test requires that courts balance (1) the private interest, (2) the risk of erroneous deprivation and the probable value, if any, of extra safeguards, and (3) the govern­ ment's interest, including the function involved and the fiscal and adminis­ trative burdens that the additional or procedural requirement would entai1!42 in regards to the private interest involved, the veterans' interests could not be higher. "[i]n assessing the injury caused by deprivations of federal benefits, we look to claimants' individual dependency on the benefits, and the poten­ tial injury incurred by losing those benefits .... "143 many disability com­ pensation recipients are either totally, or primarily, dependent upon scddc benefits for financial support, 144 as they may be jobless upon relinquishing their positions as active service members. indeed, the delay in processing these claims for benefits hinders disabled veterans' ability to make pay­ ments on their homes and other necessities. for veterans who may be experiencing the effects ofptsd, the inabil140. aaron glantz, vets health system in need of triage, inter prfss service news agency, jan. 15, 2009, http://ipsnews.net/news.asp?idnews=45423 (last visited july 21, 2009). 141. see, e.g., rodrigues, 169 f.2d at 1348 (finding that a due process claim based on "considerable delay'' in deciding the right to disability benefits was not insubstantial); krae­ bel, 959 f.2d at 405 (stating that "[d]elay in processing can become so unreasonable as to deny due process."); .andujar, 69 f.r.d. at 694 (stating that "[d]elays themselves may result in a deprivation of property."). 142. mathews v. eldridge, 424 u.s. 319,335,96 s. ct. 893,47 l. ed. 2d 18 (1976). 143. briggs v. sullivan, 886 f.2d 1132, 1145 (9th cir. 1989). 144. peake, 563 f. supp. 2d at 1070. 180 indiana health law review [vol. 7:157 ity to secure the scddc benefits owed to them only exacerbates the under­ lying disease state, leading to a sense of hopelessness which may inevitably contribute to the risk of these veterans taking matters into their. own hands, at the rate of eighteen suicides a day. "between october 1, 2007, and march 31, 2008, alone, at least 1,467 veterans died during the pendency of their appeals."145 amazingly, upon an appellant's death, the appeal is extin­ guished, thus effectively extinguishing any hope that the veteran's survivors will benefit from any scddc benefits. noting the devastating effect this can have on the veteran's survivors, proposed legislation would have al­ lowed for substitution by surviving spouses as claimants when a veteran spouse dies while a claim is pending. 146 alas, the veterans were not even afforded this relief, as the proposed legislation never came up for a vote in the senate, despite passage in the house of representatives . . when evaluating the pri~te interest of the veterans, it appears to be a very small leap in logic that this factor weighs heavily in favor ofthe.pros­ pect that.veterans are being denied due process. in addition, the risk ofer­ roneous deprivation is high. statistics brought out in veterans for common sense v. peake paint a clear picture of the level of erroneous deprivation: the bva reverses ro decisions 21 percent of the time and remands another 41 percent of the cases; the cumulative error rate on v aro decisions is over 90 percent. by the va's owri calculations, 44 percent of the reasons for remand by the bv a are "avoida­ ble,'' .... seventy-five percent of the remanded cases return to the bv a a second time, and 27 percent of those cases are remanded once again. 147 further, the district court noted that veterans benefits administration ("vba") employees ''violating their duty to assist veterans" accounted for almost half of the avoidable remands in the very short time frame between january 1, 2008, and march 31, 2008.148 the district court also stated, though, that "[i]n looking at the totality of scddc claims ... the risk of erroneous deprivation is relatively small."149 the court justifies this position by stating that only four percent of claims filed proceed to the bv a, and thus the affected veterans must ab145. !d. at 1075. 146. veterans disability benefits claims modernization act of2008, h.r. 5892, 110th cong. § 111 (2008), available at http:/lwww.govtrack.us/congresslbilltext.xpd?bill=h1105892. 147. gordon p. erspamer, the new suspect class. tragically, our veterans, aba human rigiits. spring 2008, at 20. 148. peake, 563 f. supp. 2dat 1075. 149. !d. at 1087. , 2010] saving money, not lives 181 ide by the principle that '"the effect that a process must be judged by the generality of cases to which it applies, and therefore, process which is suffi­ cient for the large majority of a group of claims is by constitutional defini­ tion sufficient for all of them. '"150 the district court, though, failed to address just how many veterans fall within that four percent affected by the va's claims adjudication process. the most recent number available states that the vba has a back­ log of "somewhere between 400,000 and 600,000" claims. 151 thus, at least 400,000 claims are awaiting final adjudication through the vba, with the possibility that those claims may not be adjudicated for 4.4 years. this hardly seems to be an insignificant percentage of veterans waiting for their scddc benefits. and with eighteen veterans committing suicide each day, this number becomes appalling. the district court did attempt to minimally address the second ma­ thews factor by stating that "although the additional safeguards plaintiffs seek would likely reduce the number of avoidable remands and erroneous deprivations, the fiscal and administrative burdens of these additional pro­ cedural requirements are significant."152 so although factor two under the mathews analysis also weighs heavily in favor of the veterans, the district court placed all emphasis on the third mathews factor. in effect, the district court deduced that the perceived administrative burden to the va for im­ plementing some of the veterans' requests for relief outweighed the veter­ ans' interests in obtaining the requested relief. but the va 's interest in ensuring accurate and timely adjudication of scddc claims is not at odds with the veterans' interest in timely adjudica­ tion; in fact, the two interests coincide. in addition, the va presented no evidence that implementation of some of the veterans' requests would present such perceived administrative burdens. the court simply held that "[i]mplementation and maintenance of such a system would be costly in terms ofthe resources and manpower that the va would need to commit to the ro proceedings."153 one such request is the ability to pay an attorney from the beginning of the claims adjudication process. given that the claim forms are excee­ dingly technical, lengthy, and difficult to fill out, and that many times claims are denied based on information contained in the initial claim form, it would seem appropriate for veterans to have the benefit of legal counsel. 150. id. at 1087 (quoting walters v. nat'l ass'n ofradiati011 survivors, 473 u.s. 305, 330, 105 s. ct. 3180,87 l. ed. 2d 220(1985)). 151. bilmes, supra note 64, at 16. see also gao long-standing claims, supra note 120; statement of daniel bertoni, supra note 120 (outlining the backlog ofvba claims and the persistent challenges to adjudicating those claims). 152. peake, 563 f. supp. 2d at 1088. 153. id. at 1088 (noting that plaintiffs requested "the general right of discovery, includ­ ing the power to subpoena witnesses and documents, the ability to examine and cross­ examine witnesses, the ability to pay an attorney, and the right to a hearing."). 182 indiana health law review (vol. 7:157 "imagine if our legal system were set up so that plaintiffs were forced to assemble, file, and argue their own lawsuits, and that attorneys could only be paid for their assistance after the initial case was lost .... "154 this is the end effect of not allowing veterans to pay for attorney as­ sistance at the outset of the claims adjudication process, per the veterans' choice of representation and benefits enhancement act of 2006.155 the district court could have granted this request, which would have benefitted the veterans and the va, without any additional administrative costs to the va. the va already employs a host of attorneys to look after its interests. it seems only right that the veterans be allowed the same legal representa­ tion. the district court, rather than engaging in an in-depth analysis using the mathews factors, instead based its due process analysis on a single so­ cial security case from the seventh circuit.156 in wright, social security disability claimants challenged hearing delays of up to 180 days and asked the court to impose time limits on the processing of claims, or else make interim payments of benefits.157 although the district court stated it found the wright decision "illuminating," the very phrases the court pulled out of the wright decision to make its case actually appear to benefit the argu­ ments the veterans put forward. for instance, the district court quoted the wright decision, stating that '"[i]n determining when due process is no longer due process because past due, the influence of other significant circumstances is not to be · ig­ nored .... delay is a factor but not the only factor."'158 these quotes ac­ tually seem to lean towards favoring the veterans, and not the va. the veterans absolutely take issue with factors other than the simple delay of claims adjudication. the veterans put forth statistics that claims for veter­ ans suffering from ptsd are more difficult for the veterans to fill out dur­ ing the initial phase of claim filing, and that these claims are more susceptible to denial based on mistakes the veterans with ptsd make due to their illness. besides, the 180 days of delay in the wright decision pales in comparison to the four-year delays experienced by veterans trying to ma­ neuver their way through the va' s claims adjudication system. the wright court went on to state that "[tjhere may be ... in the more typical situation unjustified and unreasonable delays constituting a depriva• tion of property in violation of due process requiring our interven154. craig kabatchnick, after the battles: the veterans' battle with the va, aba human rights, spring2008, at 13. 155. see 38 u.s.c. §§ 5902-5905 (2007). 156. peake, 563 f. supp. 2d at 1086 (referring to the decision in wright v. califano, 587 f.2d 345 (7th cir. 1978)). 157. wright v. califano, 587 f.2d 345 (7th cir. 1978). 158. peake, 563 f. supp. 2d at 1086 (quoting wright v. califano, 587 f.2d 345, 354 (7th cir. 1978)). 2010] saving money, not lives 183 tion .... "159 the veterans in veterans for common sense v. peake surely put forth arguments strong enough to advocate just such a judicial interven­ tion. when actually looking more deeply into a due process analysis apply­ ing the facts of the veterans' experience with the va claims adjudication process to the mathews factors, it appears as though each factor weighs in favor of the veterans, thus implying that the veterans are in fact being de­ nied due process. for those veterans whose claims are trapped in the "chum" of the va claims adjudication process, sometimes for decades, the denial of due process regarding those claims can result in the most irrepara­ ble type of harm: loss of hope, onset of despair, and sometimes even death by suicide. iv. recommendations while the evidence strongly suggests that veterans, particularly those with ptsd, are being denied constitutional due process, thus mandating judicial intervention, several recommendations exist that would grant the veterans relief without such intervention. although the court denied the veterans the injunctive relief they sought, perhaps the trial was necessary to bring the issues into sharp focus so that steps, other than judicial interven­ tion, could be taken to alleviate the suffering many veterans with ptsd experience when trying to maneuver through the va's claims adjudication system. "the government accountability office, house veterans' affairs committee staff, and the va's own inspector general have come out with report after report cataloguing shortfalls in the expenditure of funds and delivery of services" to the veterans.160 in regards to the overwhelming de­ lays seen in the va's claims adjudication system, a reasonable remedy would be to presumptively approve disability claims, particularly those re­ lated to ptsd, "to ensure no veteran languishes or falls into poverty while awaiting financial assistance."161 this approach would be strikingly similar to that employed by the internal revenue service ("irs"}, where the irs deters fraudulent claims by presuming that the taxpayer's filed return is cor­ rect and then subsequently audits those returns. ''this startlingly easy switch would ensure that the us no longer leaves disabled veterans to fend for themselves."162 159. wright, 587 f.2d at 356. 160. fairweather, supra note 18, at 24. accord gao long-standing claims, supra note 120; daniel bertoni, united states government accountability office, veterans' disability benefits: processing of claims continues to present challenges (ga0-07-562t), march 13, 2007. 161. fairweather, supra note 18, at 24. 162. bilmes, supra note 64, at 18. 184 indiana healm law review [vol. 7:157 despite this. simple proposed solution, va spokesperson kerri chil­ dress stated that "[v]eterans are human.... some are in desperate situa­ tions. some have the choice of going to jail or the military. so a portion of them would commit fraud."163 ms. childress goes on to say that "[e]liminating the proof requirement would open the va's checkbook to fraudulent claims .... "164 nevertheless, part of the district court's very decision in veterans for common sense v. peake to refuse the veterans re­ lief for denial of due process centered around the fact that "only" four per­ cent of veterans who file claims are ultimately affected. if this is true, then over ninety· percent of initial claims are approved. as an initial safeguard against the fraud that ms. childress fears would be rampant, the va could start small: automatically approve ptsd claims ''with the understanding that deployment to iraq and mghanistan means vba concedes there was at least one stressor sufficient enough to cause ptsd, unless there is evidence to the contrary."165 yet another suggestion to reduce the number of backlogged claims is to "fast track" claims submitted by returning iraq and mghanistan veterans in a "single center staffed with highly experienced group of adjudicators who could provide most veterans with a decision within 90 days."166 this could be readily accomplished by expanding "the vet centers to offer some assistance in helping veterans figure out their disability claims.''167 this solution would grant greater access to the veterans than the current system, where the veteran has to travel to one of the fifty-seven va regional offic­ es throughout the country to file a claim for scddc benefits. for the ptsd veteran, the increased access to both experienced claims adjudicators and filing locations would not only ease the process of filing, but would better ensure that the initially filed claim was prepared appropriately. finally, "attorney representation should be available from the earliest claims stage."168 the services of attorneys can ensure the successful com­ pletion of the very complex ptsd claim. umepresented ptsd veterans have great difficulty in preparing and filing their scddc claims, especially since the very condition giving rise to the claim adversely affects the veter­ an's ability to do so. currently, a veteran is allowed to pay for legal counsel only after a 163. joshua kors, how the va abandons our vets, the nation, sept. 15, 2008, avail­ able at http://www.thenation.com/doc/20080915/kors (last visited july 21, 2009). 164. id. 165. hearing on regional office solutions to reduce the 65,000 claim backlog at the veterans benefits administration: hearing before the subcommittee on disability assis­ tance and memorial affairs of the h. comm. on veterans' affairs, i loth cong. appendix (2008) (statement of paul sullivan, executive dir., veterans for common sense). 166. bilmes, supra note 64, at 18. 167. id. 168. fairweather, supra note 18, at 24. 2010] saving money, not lives 185 veteran's initial claim for scddc benefits has been denied.169 this seems to be a counter-intuitive way to assist the nation's veterans with the filing of their scddc benefit claims. it is at the initial filing that veterans are in desperate need of legal assistance. the initial filing is the veteran's oppor­ tunity to produce the evidence necessary to prove his claim for scddc benefits. this includes the presentation of such evidence as: (1) statements from doctors who have provided treatment for the disability at issue over a prolonged period of time; (2) submission reports from board-certified medical doctors who specifically specialize in the field of medicine for which the claimed disability is at issue; and (3) articles and citations from recognized medical treatises, buddy statements, morning reports, evidence of citations, or other proof to help the veteran develop his or her claim for disability compensation or pension. 170 clearly, this burden would be difficult for any veteran, but most especially for a ptsd veteran who may be experiencing the very symptoms that lead him to file the claim in the first place. opposition to allowing attorneys to be involved from the initial stage of claim filing argue that such action would "make the va claims adjudica­ tion process adversarial rather than nonadversarial, as intended."171 but the experiences that the veterans have at the initial filing of claims for scddc benefits strongly suggest that the va claims adjudication process is no longer nonadversarial in nature. "the burden of proof is always on the vet­ eran to somehow prove that his or her claim for service-connected benefits is meritorious and worthy of a grant of service-connected benefits."172 the initial twenty-three page disability application is "loaded with charts and legal jargon."173 it would only seem right that a nation wishing to provide for the veterans who served our nation would do so by allowing the veter­ ans the right to pay for legal assistance at the most critical stage of request­ ing scddc benefits: the very first stage of claims filing. in sum, the va could avoid what may prove to be inevitable judicial intervention by implementing several recommendations made by different sources. these recommendations include 1) presumptively approving disa­ bility claims, particularly those related to ptsd, 2) fast tracking claims 169. 38 u.s.c. §§ 5902-5905 (2007}. 170. kabatchnick, supra note 154, at 15. 171. !d. at 16. 172. !d. 173. kors, supra note 163. 186 indiana health law review [vol. 7:157 submitted by returning iraq and afghanistan veterans, and 3) allowing vet­ erans the option of attorney representation at the earliest stage of the claims benefit process. v. conclusion it is an undisputed fact that eighteen veterans a day, or close to 6,000 veterans a year, commit, or attempt to commit suicide. the lawsuit brought by the two advocacy groups in veterans for common sense v. peake brought to the nation's attention some of the underlying reasons for this stark statistic. although this lawsuit sought injunctive relief against the va and not damages, the district court could not seem to find in its analysis of the facts presented that the va claims adjudication system does, indeed, deny due process for veterans; particularly those experiencing the disease state ofptsd. although it seems evident that judicial intervention is not precluded from offering the veterans the relief they seek, perhaps the bringing of this lawsuit served a different purpose. by acknowledging that there is a signif­ icant underlying problem with the va's claims adjudication system, this lawsuit perhaps opened the door to alternatives solutions. these alterna­ tives may alleviate some of the stress veterans experience in filing for scddc benefits: stress that could ultimately contribute to a veteran's deci­ sion to take his life. by implementing some of the well thought out alternatives to judicial intervention, the va could streamline the claims adjudication process with minimal effort and accomplish the goal of providing for our nation's return­ ing war veterans, thus averting what appears to inevitably be judicial inter­ vention. presumptively approving disability claims (particularly those related to ptsd), fast-tracking claims submitted by returning iraq and afg­ hanistan veterans in a single center staffed with highly experienced group of adjudicators, and allowing legal representation at the initial stages of filing claims for scddc benefits would significantly relieve the backlog of claims that currently plagues the va. although the va's claims adjudication process should be scrutinized to ensure due process and the timely disposal of claims, perhaps by imple­ menting the suggestions put forth by a variety of knowledgeable sources the va could once again commit to its own motto: to care for him who shall have borne the battle and for his widow and his orphan. louise g. trubek professor louise g. trubek is clinical professor at the university of wisconsin law school. she teaches health law and alternative approaches to regulation: law and policy. she directs the health law project at the law school that includes a health law externship program. prof. trubek writes extensively on health care law, regulatory reform, public interest lawyering, and clinical legal education. her current research fields are new approaches to governance in the unites states and in the european union, health care law, and public interest lawyering around the world. recent publications include crossing boundaries: legal education and the "new public interest law," wis. l. rev. 455, 470-01 (2005), new governance practices in u.s. health care, in law and new approaches to governance in tile european union and the united states (deburca & scott eds., 2006), health care and low-wage work in the united states: linking local action for expanded coverage, in governing work and welfare in anew economy (zeitlin & d. trubek, 2003), and achieving equality: healthcare governance in transition, with maya das, am. j. l. & med. (2003). new governance and soft law in health care reform louise g. trubek• introducfion health care reform is underway. to resolve longstanding health care problems, reformers are using new technologies, revising the role of public agencies, expanding the use of information, and creating flexible and participatory tools. these processes are different from previous understand­ ings of health care governance. they are based on an emerging set of practices that can be called ''new governance," ''post-regulatory," or ''new proceduralism." new governance includes devolution, public-private partner­ ships, new types of regulations and incentives, network creation, coordinated data collection and dissemination, benchmarking, monitoring, and active patient participation. one aspect of new governance is a transformation of how we think of law; it includes guidelines and benchmarks that have no formal sanctions. these techniques are intertwined with the reenvisioning of how to improve health care. reformers are using these new processes to tackle three health care conundrums: universal access, reducing racial and ethnic dis­ parities, and embedding information technology. these new processes consist of six innovative mechanisms that are utilized to resolve the health care conundrums: 1) alternative sites; 2) consumer and patient participation; 3) different roles for government; 4) redesigned organizational forms; 5) alternative methods for dispute resolution; and 6) new regulatory tools. these innovations can be understood in the framework of new governance practices and soft law regulatory reforms. the new governance mechanisms are interacting with the older governance systems. the coexistence of the two systems creates different types of interactions. one interaction is a dynamic rivalry between the old and new, a second is orchestrating a multipronged strategy that incorporates new governance techniques with more traditional incentives, and a third is integrating traditional legal values into the new processes. * j.d., yale law school; clinical professor of law, university of wisconsin law school, director of the health law project at the university ofwiscoilsin law school. some of the ideas discussed in this paper are also referred to in my article new governance practices in u.s. health care, law and new governance intheeu and theus (de burca and scott eds., 2006). many thanks to my excellent research assistants. jessica levie and joseph seales, for their invaluable research and writing contributions. 140 indiana health law review [vol. 3:137 the article begins with a discussion of contemporary health care reform and describes the three health care conundrums that frame the reform efforts. the first conundrum is creating universal coverage. the article describes how the reform effort is using incremental approaches that include experimentation at the state level. the second conundrum is how to embed new technology into the currently fragmented system. the reform effort is using national standards implemented through diverse regional collaboratives. the third conundrum is how to eliminate racial and ethnic disparities. the reform efforts are proposing to utilize newly developing quality indicators. the article then places these health care reform stories in the context of a broad regulatory reform. the article describes the particular new governance mechanisms that can be observed in these health care reform stories. the article concludes with a discussion of the variety of interactions between new governance and the older systems and proposes that the values of participation, transparency, and equity can be maintained within the new regulatory reforms. i. health care reform: three stories eighty-two percent of americans rank health care among their top concerns. 1 people are satisfied with health care when they can get it but are afraid they will not be able to secure it over forty-five million people were without health insurance during 2003.2 the poor quality of health care has been well documented, but an extremely complicated health care scheme makes the problem seem unsolvable. health care coverage is provided through a mixture of public, private, and nonprofit systems. it delivers local services through federally controlled programs such as medicare, and through varied benefits provided by employer-based plans. the competitive world economy is straining the employer-based health care system because, unlike many nations, a large portion of health care costs is paid by employers. 3 rising health care costs are also a major issue straining the fiscal budgets at the state level due to medicaid, and at the federal level due to medicare. another driver for reform is the medical malpractice system that is no longer efficient or equitable in deterring negligence and redressing patient harins. systems such as evidence-based medicine combined with the collection and 1. paul krugman, the health of nations, n.y. times. feb. 17, 2004, at a23. 2. u.s. census bureau, current population reports, p60-226 income, poverty, and health insrmmce coverage in the united states: 2003, 14 (2004). 3. daniel akst, the hidden price tag for health care, n.y. times. dec. 12, 2004, at bu6. 2006] new governance and sofi' law in health care reform 141 dissemination of data are being proposed as alternatives methods to reduce errors and compensate patients. 4 another aspect of the conteniporary context is the failure of ambitious proposals to improve the health care system, such as the clinton administra­ tion health plan and the managed care movement of the 1980s. the clinton health plan was an effort to achieve universal health coverage through an elaborate, federally controlled system. that plan was defeated, in part, because it was viewed as an attempt to replace the existing diverse and complex health care system with a mammoth bureaucracy.5 the failure is viewed as a blow against centralized, government dominated, bureaucratically controlled governance. 6 the experiment with managed care, represented as a managed competition approach to solving health care problems, has also reached a plateau due to a perceived consumer desire for choice and the limits of its initial cost savings. 7 stakeholders realize that these problems can and must be tackled, even in this complex environment. stakeholder groups include physicians, health care providers, business, government, consumers/patients; and technology experts and entrepreneurs. a set of reformers is emerging from the stake­ holders. 8 these reformers are leaders in creating new techniques and theories that challenge the older systems. there is an understanding among the reformer stakeholders that change is essential for the economic and personal health of the nation, and that their actions are creating the basis for that change. there are three specific conundrums where the reform efforts are directed: 1) achieving universal coverage; 2) embedding technology into health care delivery; and 3) attaining high quality care for all. 4. william m. sage, unfinished business: how litigation relates to health care regulation, 28 j. realm pol. pol'y & l. 387, 399 (2003). medical disciplinary boards have also proved to be oflimited use as a way of preventing medical errors and of providing redress for patients. see also ruth horowitz, medical licensing and discipline in the united states: medical, legal and public discursive domains (june 2005) (unpublished manuscript, on file with author) (discussing the effect on medical disciplinary boards). 5. louise g. trubek. health care and low-wage work in the united states: linlcing local action for expanded coverage, in governing work and welfare in tile new economy 292 (jonathan zeitlin & david m. trubek eds., 2003). 6. id 7. see mark hall, the "death" of managed care: a regulatory autopsy, 30 j. realm pol. pol'y & l. 427 (2005). 8. see, e.g., tommy g. thompson, foreword: the state of america's health care system, 31 wm. mitchell l. rev. 805 (2005); donald m. berwick & thomas w. nolan, physicians as leaders in imposing health care: a new series in annals of internal medicine, 128 ann. int; men. 289 (1998); troyen brennan, see links to his homepage, research affiliations and articles at http://www.researchmatters.harvard.edu/people.php? people _id=459 (last visited june 5, 2006); ron pollack, families usa: the voice for health care consumers, at http://www.familiesusa.org (last visited june 5, 2006). 142 indiana health law review a. universal coverage: from a centralized, single system to incrementalism [vol. 3:137 the lack of universal coverage has long been the most noted deficiency in u.s. health care. the importance ofinsurance in the united states results in poor health care for those who are uninsured.9 in addition, lack of coverage results in the shifting of the costs for providing care of the uninsured onto two sets of payers: the employers, who pay more because the medical establish­ ment shifts added.costs, and the government payers, who are forced to raise taxes in order to cover their share of uncompensated care. lack ofcoverage also affects the economy by encouraging job lock where employees cannot move to the position that matches their talents because of their fear of losing health care coverage.10 there is now an acknowledged consensus that some form of universal coverage for residents is essential for the economic and personal health of the united states. 11 this consensus has developed for two reasons: the acknowledgment by business groups that universal coverage is crucial for its success and a shift in vision to one based on an incremental approach rather than a radical restructuring. the incremental approach grew in popularity in the wake of the clinton plan's failure. 12 the incremental approach reassures business and providers who fear a government controlled, one-size-fits-all model for health care. it de-emphasizes the bureaucratic, single set of universal benefits and administration. business groups are getting involved because they see that solving the uninsured problem is necessary for their own economic health and the competitive situation of the united states in the world economy. business groups understand, to the extent they can no longer afford their own health care programs, other programs to cover their workers will have to be designed and funded. 13 the incremental approach to universal coverage is proceeding on four tracks: 1) experimenting at the state level; 2) integrating networks with federal funding; 3) linking public and private coverage; and 4) incorporating coverage 9. see karen davis, the costs and consequences of being uninsured, 60 med. care res. & rev. 2 (2003). l 0. kevin t. stroup et. al., chronic illiness and insurance-related job lock (march 2000),avai/ableathttp://www-cpr.maxwell.syr.edu/cprwps/wpsl9abs.htm(lastvisitedjune4, 2006). 11. the business case for universal coverage is increasingly documented. see, e.g., paul fronstin, the "business case" for investing in employee health: a review of the literature and employer self-assessmenis, ebri issue brief no. 267 (march 2004). 12. thomas r. hefty, facing health care tradeoffs: costs, risks, and the uninsured, 14 la folleite pol'y report (robert m. la follette sch. of pub. aff., univ. of wis.­ madison), winter 2003-04 at 19. 13. in cases like general motors profits are falling. see matt miller, ceos should force health care issue, wis. statej.,may22, 2005, at b2. for wal-mart the issue is covering low wage workers. see stacy forster, big companies fill badgercare rolls, milwaukee j. senrinel, may 24, 2005, at ai. 2006] new governance and soft law in health care reform 143 for the uninsured through pooling and incentives. there is now a rich array of state approaches to providing coverage. in the 2005 budget debate, the national governors association united across bi-partisan lines to oppose massive cuts in medicaid and to develop a system for reforming medicaid that cut costs while maintaining coverage levels and improving quality. the medicaid cuts were reduced and a high-level medicaid commission is being appointed. 14 this commission's goal is to work with a variety of stakeholders, including state and federal leaders, to figure out ways that medicaid funding can be used more efficiently to expand access and improve quality.15 the governors association's effectiveness in the recent medicaid debate is based on its state-by-state incremental approach. state governments are experimenting with various methods trying to figure out ways of putting the pieces together to achieve greater coverage. 16 combining public programs with employer-based coverage is being proposed through further expansion of medicaid. small businesses are encouraged to offer health care coverage through a combination of tax credits and subsidies from government programs. 17 private businesses can be integrated into state employee coverage pools to reduce businesses' health care costs.18 informa­ tion technology enables people to move from public plans to private coverage and vice versa with no loss of coverage when their jobs and income situations change. 19 states are emphasizing quality techniques, patient involvement, and community participation to improve care.20 networks of state government 14. lawmakers express anger over leavin medicaid commission, wash. healthpol'y week inr. (the commonwealth fund), may 23,2005, available at http://www.cmwf.org (last visited june 4, 2006). 15. id. 16. a recent study indicated that the quality of care received through medicaid is equivalent to the care received by low income. privately insured adults. this information supports the usefulness of considering options for expanding medicaid or expanding coverage for low income people through private plans, perhaps with a government subsidy. see teresa a. coughlin et al., assessing access to care under medicaid: evidence for the nation and thirteen states, 24 health aff. 1073, 1077 (2005); state health insurance: making affordable coverage available to all americans, in fostering rapid aov ances in health care 69, 76 (inst. of med. 2002). 17. see democratic policy committee, senate democrats introduce affordable health careplanfor small business (march 7, 2006), available athttp://democrats.senate.gov (follow "newsroom" hyperlink) (last visited june 4, 2006). 18. david callender, health plan would cover all in state, capital times, june 15, 2005, atal. 19. hefty, supra note 12, at 19. see also state health insurance: making affordable coverage available to all americans, in fostering rapid advances in health care 69 (inst. of med. 2002). 20. frist-bingaman bill would allow uninsured children to enroll in medicaid, schip, wash. health pol'y week in r. (the commonwealth fund), may 23, 2005, available at http://www.cmwf.org. the incremental approach is based on states combining the resources of the medicaid program as expanded through the state children's health insurance program (scrip) funds. scrip is an expansion of health care coverage targeting uninsured children. the federal government, in enacting scrip, encouraged states to experiment with various 144 indiana health law review [vol. 3:137 officials, legislators, and governors across states are spreading"bestpractices" and encouraging united action to support the programs.21 b. embedding technology: from command and control to national standards arid regional collaboratives reformers are pursuing major initiatives to embed technology in the health care system.22 there is a bi-partisan alliance between former republi­ can speaker newt gingrich; democratic representative patrick kennedy, and democratic senator hillary clinton. the alliance is committed to advancing technology that could radically transform the quality and reduce the cost of healthcare. 23 however, there is reluctance in the medical community to invest in technology because of high costs, a perceived loss of autonomy in exercising professional expertise, and fear of a centralized data set.24 there is also difficulty in developing a, national system that protects privacy and security. 25 the bush administration has proposed a national health care regional infrastructure which will be responsible for coordinating all private sector initiatives under the :framework of the american health information community ("ahic").26 the goal is to create a comprehensive, knowledge­ based network of interoperable systems capable of providing information anytime, anywhere. it is, however, not a central database ofmedical records. the role of the federal government is to ensure that standards are in place to allow the interoperable systems; the model is the banking information infrastructure. the proposal is for ''regional'' systems that could be smaller or larger than states; it is coordinated through the federally funded connecting communities for better health program. 27 the ahigis a forum that includes seventeen commissioners representing consumers, privacy interests, states, payers, providers, vendors, and purchasers. 28 the group is "chartered for two years, with the option to renew up to five years, to be succeeded by a privateapproaches to insuring children and families with the additional funding. 21. trubek, supra note 5, at 292. 22. information and communications technology infrastructure: a "paperless" health care system, in fostering rapid advances in health care 57 (inst. of med. 2002). 23. id 24. newt gingrich &: patrick kennedy, operating in a vacuum, n.y. times, may 3, 2004, ata23. 25. press release, office of the nat'l coordinator for health info. tech., secretary leavitt takes new steps to advance health it (june 6, 2005), available at http://www.hhs.gov/newslpress12005pres/20050606.html (last visited june 4, 2006). 26. id 27. website funded through an agreement with the health resources and services admin. office for the advancement oftelehealth, available at http://telehealth.hrsa.gov (last visited feb. 23, 2006). · 28. new steps to advance health it, supra note 25. 2006] new governance and soft law in health care reform 145 sector health information community initiative. "29 while the federal government is initiating this effort, its investment is relatively modest. these ongoing efforts build in part on the experience with the health insurance portability and accountability act of 1996 {"hip aa"). hip aa delegated power to the department of health and human services ("hhs") to promulgate rules to advance health care technology through uniform standards for electronic transactions, privacy protections, and security of data. the production of these rules relied on the traditional rule-making process and took many years and many hearings to finally produce pages of rules. the implementation of hip aa, however, also included a series of public-private collaborations, known as hipaa collaboratives.30 these state-based and local collaboratives consist of all the stakeholders: business, government, technology experts, and providers from all types of backgrounds.31 since hipaa has been enacted, these groups have been helping their members comply with hip aa by providing information and sharing techniques. 32 c. guaranteeing quality and equity: from anti-discrimination and medical malpractice to quality assurance tools the reformers realize that just having health insurance is not enough to guarantee health; the care must be of high quality. since the late 1990s, reformers from the medical sector and concerned business purchasers have promoted quality as an achievable and necessary goal for the health care system.33 although the united.states has one of the most expensive health care systems in the world, the quality of care is mixed. the national healthcare quality report indicates that the u.s. system currently does not do enough to prevent diseases, diagnose early to improve treatment outcomes, or provide coordinated care to patients with chronic diseases.34 in addition, uneven quality is particularly noticeable in connection to the disparities of health outcomes of racial and ethnic minorities. studies have shown that minority americans receive less health care, and what they do receive tends 29. jd 30. see wendy netter epstein, bottoms up: a toast to the sut;:cess of health care collaboratives . .. what can we learn?, 56 admin. l. rev. 739 (2004). 31. jd. 32. jd. 33. see, e.g., the leapfrog group for patient safety, available at http://www.leapfroggroup.org (last visited feb. 23, 2006). 34. agency for healthcare res. and quawy, u.s. i>ep't of health & human servs., national healthcare quality report 2-4 (2003), available at http://qualitytools.ahrq.gov (follow "national healthcare quality report 2003" hyperlink) (last visited june 4, 2006). 146 indiana health law review [vol. 3:137 to be lower quality care, even when controlling for insurance status and income.35 in response to the documentation of the persistence ofhealth disparities, there is a major initiative to adopt a quality-based approach to the provision of health care as an indirect route to achieving equality. a recent report indicates ''leveraging existing quality assurance systems to monitor and address disparities could substantially reduce the disparities in healthcare treatment."36 if the quality problems can be resolved, the way is opened to both a high-quality health care system, and to a reduction in health disparities. once providers and payers are committed to the assessment and measuring of quality, they can use these techniques to access and improve the outcomes for racial and ethnic minorities. there is evidence that publication of quality indicators can be an effective way to improve quality for minority populations. a recent study demonstrated that the quality of care improved for minority populations when public data on the success of physicians were made available and distributed to minorities.37 ii. new governance and soft law historically, in health care, there has been a mix of self-regulation, market forces, and government regulation. 38 rand rosenblatt defines this mix as the remains of the three ages of health law: 1) authority of the medical profession; 2) modestly egalitarian social contract; and 3) market competi­ tion.39 the authoritative period of health law was characterized by self­ regulation and accreditation as the preferred ways to govern. the second age that rosenblatt defines as "modest .social contract" is sometimes called the "new deal/great society period. h40 this age emphasized command and control based in washington, d.c. the administrative agencies issued periodic rules 35. sidney d. watson, race, ethnicity and quality of care: inequalities and incentives, 27 am. j.l. & med. 203, 208-09 (2001). 36. kevin fiscella, within our reach: equality in health care quality, symposium, racial and ethnic disparities in health care treatment, the harvard civil rights project (may 18, 2004) (unpublished manuscript, on file with author). 37. dana b. mukamel et al., quality report cards, selection of cardiac surgeons, and racial disparities: a study of the publication of the new york state cardiac surgery reports, 41nquiry 435 (2004-05), available at http://www.inquiryjoumalonline.org (last visited june 4, 2006). 38. troyen a. brennan, the role of regulation in quality improvement, 76mn.bank q. 709(1998),availableathttp://www.blackwell-synergy.com/doilabs/10.1111/1468-0009.00lll (last visited june 4, 2006) .. the argument is that in no substantive area was there ever true self­ regulation because there was always some government action in someway, be it administrative, legislative, or judicial. 39. see rand e. rosenblatt, the four ages of health law, 14 health matrix 155 (2004). 40. see orly lobel, the renew deal: the fall of regulation and the rise ofgovemance in contemporary legal thought, 89 minn. l. rev. 342 (2004). 2006] new governance and soft law in health care reform 147 and emphasized professional expertise as the source of information and knowledge. there was an emphasis on entitlement programs and a reliance on individuallitigation.41 since the 1970s, critics of government regulation have called for alternatives to the new deal/great society model.42 rosenblatt defined the period that comprised privatization, deregulation, and reliance on market competition as the third age. 43 managed care is one manifestation of that age. while managed care succeded in briefly reducing costs, it engendered a backlash from physicians and consumers. the widely used phrase was that it "managed costs not care." the inability of these tools and institutions to resolve health care problems is highlighted in the failure of the clinton health plan. "president clinton attempted to solve these problems with a national health insurance proposal that ingeniously combined the social contract, market competition, and professional authority models, but was unable to mobilize the political support to overcome intense opposition. •>44 the health reform stories discussed earlier describe an emerging set of practices that can be called ''new governance," ''post-regulatory," or "new proceduralism.'"'5 in a recent article, rosenblatt posited that these practices can be called a fourth age of health law.46 these new governance techniques are intertwined with the reenvisioning of how to improve health care. this fourth age is linked to a more general shift in the evolution of governance. while this paper describes new governance in health care, other sectors are also affected by these emerging practices. new governance is a broad phenomenon and its tenets are shared in different sectors like work place safety programming and the environment 47 the word ''new" does not imply that it has been invented recently; rather.it.is used to refer to the widespread 41. for an extensive discussion of these issues see william h. simon, solving problems v. claiming rights: the pragmatist challenge to legal liberalism, 46 wm. & mary l. rev. 127 (2004). in health care, medical malpractice is used to redress negligent errors and civil rights litigation is used to redress discriminatory behavior. 42. see mark tushnet, the newconstitutionalorder.1-5 (2003). 43. see rosenblatt, supra note 39. 44. rosenblatt, supra note 39, at 175. 45. scottl. cummings, mobilization lawyering: community economic development in the figueroa corridor, in cause lawyers and social movements (austin sarat & stuart scheingold eds., stanford univ. press. forthcoming 2006)(post-regulatory); wo1fheydebrand, hard but soft: having law both ways? (march 2005) (unpublished manuscript, on file with author)(newproceduralism);lesterm.salamon,thenewgovernanceandthetoolsofpublic action: an introduction, 28 fordham uim. l. j. 1611, 1635 (2001) (new governance). 46. rosenblatt, supra note 39, at 193. 4 7. see orly lobel, interlocking regulatory and industrial relations: the governance of workplace safety, 51 admin. l. rev. 1071 (2005) (osha); bradley c. karkk:ainen, environmental lawyering in the age of collaboration, 2002 wis. l. rev. 555 (2002) (environmental). 148 indiana heal1h law review [vol. 3:137 and explicit use ofnonconventional forms of governing.48 it recognizes that privatization can bring important new tools to help solve problems (like market-based approaches), but "private markets cannot be relied on to give appropriate weighfto public interests over private ones without active public involvement." 49 new governance includes devolution of government, public-private partnerships, new types of regulations and incentives, network creation, coordinated data collection and dissemination, benchmarking, monitoring, and active individual involvement. 50 devolution moves power to lower levels of government, including local and state, and de-emphasizes inflexible nationally· administered programs. there is a multilevel interaction in which the national government sets standards, or provides funding with a relationship among the federal, state, and local level. experimentation is closely linked to devolution, since the more local an entity is, the easier is experimentation. often, experi­ mentation occurs outside of, or parallel to, regulation. 51 experimentation can also· be seen as continuous quality improvement-organizations should be constantly experimenting to see what works and what does not. 52 there is experimentation with different models of resolving problems at the state and local levels. it is producing information about what works and does not work, and this information is shared through shareholder networks, such as networks of government officials and business purchasers. another element is public-private partnerships. here, traditionally isolated organizations and programs are brought together to work on shared problems, crossing barriers of diverse corporate forms and competing constituencies. it is also closely linked to networking-a process oflearning from the field what works and adapting. the use of networks also changes the government's role because it no longer regulates organizations to achieve desired outcomes. while negotiation through networks may be difficult, rules and standards that have been negotiated by the networks may be complied with because of the negotiation process. 53 traditional governance has been skeptical of collaborations between private and public entities. new governance recognizes that public/private networks have different strengths that can be used in concert to solve public problems.54 the collection of data is emphasized in order to evaluate whether 48. taskforce on legal issues ii, new modes of governance in europe(newgo}, may 16, 2005 (grainne de burca ed.}, available at http://www.eu.newgov.org(fouow"publications" hyperlink) qast visited june 6, 2006). 49. salamon, supra note 45, at 1635. 50. salamon, supra note 45, at 1635. 51. louise g. trubek, lawyering for a new democracy: public interest lawyers and new governance: advocating for health care, 2002 wis. l. rev. 575, 594 (2002). 52. i d. at 587. 53. wendy netter epstein, bottoms up: a toast to the success of health care collaboratives, what can we learn?, 56 admin. l. rev. 739 (2004). 54. id at 1633-34. 2006] new governance and soft law in health care reform 149 goals that are set and benchmarked are achieved. there is an emphasis on. monitoring results through the collection and public dissemination of data that can lead to revisions and create financial incentives. ss new governance is transformative of law in that it challenges what we think of as law. guidelines, benchmarks and standards that have no formal sanctions are important elements in new governance. there is also a develop­ ment of informal processes to resolve grievances and disputes, including negotiation and multistepped procedures. 56 this can be called "soft law." soft law is an important component of new governance practices. 57 "hard law" can be characterized as command and control, court based dispute resolution, uniform rules, punitive sanctions, and court challenges for noncompliance. this approach has proved inadequate in many cases. first, the use of court challenges to enforce regulations has been ineffective because the problems seeking to be solved are extremely complex. there is a lack of fit between the institutional structures that are causing the failure to solve problems with the traditional court remedies. 58 second, the failure of the anti­ discrimination paradigm in racial and ethnic disparities is an example of the inadequacy of exclusive reliance on court remedies. another failure of traditional regulation is the use of malpractice litigation as the major tool to prevent errors and improve quality of care. the random selection of cases, the high cost oflitigation, and the resistance of health care institutions to use the information gained in lawsuits.are all problems with malpractice litigation. 59 finally, there is a famed gap between the law on the books and the law in action. uniform rules are not enforced by the agencies, nor does enforcement necessarily lead to the desired outcome. 60 the perceived inability of the hip aa rules to advance the consumer's interest in health data collection is an example of the gap between law on the books and effective achievement of the goal of assuring privacy and improving care. soft law allows for learning and feedback. it allows actors to take on multiple roles, and creates alliances between traditional adversaries. further, soft law incorporates economic incentives into the governance framework 55. one observer has said health care reform is all about purchasing for value. dave riemer, commentary by dave riemer at univ. ofwis. med. sch., april4, 2005 (comments on file with author). 56. see alexander j.s. colvin, from supreme court to shopfloor: mandatory arbitration and the reconfiguration of workplace dispute resolution, 13 corneu.j.l. &pub. pol'y 581 (2004). susan sturm, second generation employment discrimination: a structural approach, 101 colum. l. rev.458 (2001 ). nan d. hunter, managed process, due process: structures of accountability in health care, at http://www.ssm.com (follow "search" hyperlink, then author's name) (last visited june 6, 2006). 57. see david m. trubek & louise g. trubek, hard and soft law in the construction of social europe: the role of the open method of coordination, 11 bur. l. j. 343 (2005). 58. charles f. sabel & william h. simon, destabilization rights: how public law litigation succeeds, 117 harv. l. rev.1015, 1070 (2004). 59. sage, supra note 4. 60. hard and soft law, supra note 57, at 356. 150 indiana health law review [vol. 3:137 while allowing for diversity and experimentation. it allows public and private domains, and different regulatory clients, to interact more easily. "it can encourage mutual cooperation and exchanges of knowledge and experience through collection, systematization, and diffusion ofknowledge. soft law can be seen as fostering consensus making and incentives to voluntary learning, as much as by shaming.'>61 this discussion shows how new governance is transformative of traditional law. however, in assessing new governance it is important to evaluate how these techniques maintain the traditional legal values of inclusion, equity, participation and transparency. 62 the larger issue is whether this evolving system can be both popular and effective. the partial failure of managed care and the demise of the clinton health plan were due to the inability of the reformers to demonstrate that people would be better off and treated fairly under that governance system. skeptics of new governance believe that the issues of transparency, fragmentation, the unproven success of new tools, and the imbalance of power are major obstacles to the promise of new governance. 63 the health care stories-creating universal coverage, embedding technology, and reducing disparities-demonstrate that there is an emerging set of soft law elements crucial for new governance. these innovations also include elements of more traditional legal processes and values. part three describes these innovations. part four indicates how these innovations demonstrate the coexistence of new governance and soft law with the traditional legal processes and values. ill. innovations the older system, without some changes, cannot deal with diversity, the development of new technologies, the increasing flow of new knowledge, and the eroding faith in professionalism. the old system cannot deal with the increased information available through the combination of evidence-based medicine and electronic records. this increased information has created an explosion of new knowledge which depends on feedback and iteration. this feedback requires interaction between domains; for example, the information obtained from the public and private payer must be integrated at the policy and 61. kerstin jacobsson, between deliberation and discipline: soft governance in eu employment policy (unpublished manuscript, on file with author). 62. david m. trubek&louiseg. trubek, thecoexistenceofnewgovemanceandlegal regulation: complementarity or rivalry?, july 2005 (unpublished manuscript, on file with author). 63. 1ushnet, supra note 42, at 167-68. tushnet has characterized the conservatives as having a vision and agenda that is persuasive and may be implemented. he sees the new governance vision as one of the few efforts to create a liberal counterpoint to the conservative vision. 2006] new governance and sofi' law in health care reform 151 clinical level for the whole picture to emerge. it also allows traditional public health to be merged with health care delivery; a physician with ten diabetic patients using the same treatment protocols can obtain information about diabetes treatments, and share this internally, as well as with other institutions. the use of benchmarking will lead to increased learning. ab benchmarking is utilized, new ways to do a better job emerge. the older system must be changed to reorient to a new, more productive system. the combination of linking information technology with evidence-based medicine, new roles for the actors, and aligning incentives can lead to redesign and innovation of health care practices. 64 these innovations that are being created are the key elements of new governance in health care. the first innovation is alternative sites that create locations for stakeholder interaction and implementation of programs and projects. the second innovation is the enhanced role of consumer/patient participation. part of the reason older systems cannot adapt is the difficulty of figuring out how to integrate the essential knowledge of patients/consumers into the decision-making. the government's role becomes a set of practices that can be employed differently depending on the specific problem to be resolved. the role of private organizations shifts as well. the traditional distinction between public and private becomes less effective as the government allows more economic and market incentives to play a role and as private corporations take on a more socially-oriented function. while the innovations often result in larger units, such as public/private pooling, they also encourage development of smaller units, such as local clinics that can deliver care specific to the cultural and geographical needs of the community. furthermore, the traditional court-based dispute resolution system may be ill­ suited for some of the new governance focus on continuous learning. how­ ever, redress for the individual is essential for the legitimacy of the processes. dispute resolution systems provide for this redress using "alternative forms of victim compensation through administrative processes similar to workers compensation and conflict avoidance through informal methods to explain and apologize for error.'o6s finally, the new governance system uses information as a regulatory technique by publishing data on outcomes, offering fiscal incentives for good performance by hospitals and clinics, and issuing rules that allow diverse ways of achieving positive outcomes. a. alternative sites for deliberation and implementation the failures of the late 1980s and the 1990s emboldened key stake­ holders to overcome traditional animosities and self-interests to experiment 64. barry p. chaiken, address at the digital healthcare conference (june 9, 2005) (unpublished presentation, on file with author). 65. coexistence ofnew governance, supra note 62. 152 indiana health law review [vol. 3:137 with new ways of providing and paying for health care. the traditional arenas that brought together stakeholders to debate, deliberate, and resolve problems were the administrative agency rulemaking process, courts, markets, and self­ regulation. however, none of these arenas worked: stakeholders were missing, locations were inflexible, experimentation and diversity were difficult to achieve, enforcement relied heavily on sanctioning, and the new available technology could not be integrated into the existing systems. reformers are creating new sites that encourage collaboration pre­ viously difficult to achieve. the most common sites of collaboration consist of stakeholders that convene to solve health care problems or crises. examples of these new sites are quality collaboratives, local technology groups, and groups planning to pool public and private coverage systems. 66 these collaboratives exist at the local and state levels. there are national groups, as well, such as the national committee for quality assurance and the national quality forum.67 the founders of the collaboratives realize that bringing varied expertise and experiences to the collective governance structure is essential to understand the issues and to create solutions.68 participating at these sites are the health care stakeholders: providers, consumers, government, and employers. 69 each stakeholder has important information that, when shared with all stakeholders, improves understanding and the ability to address problems. 70 these new collaboratives may decide to bring in more organizations or develop local pilot projects. this exploration may lead to different analysis of problems and solutions than initially envisioned. four sets of reformers are now emerging as proponents and leaders of alternative approaches to solve the health care conundrums through these new collaborations: pioneering physicians, concerned payers, active consumers, and facilitating government leaders.71 each reformer group participates in various networks, alliances, and forums to solve health policy problems. each participant has a constituency that must accept working with the new alliances. these leaders must also change the culture oftheir constituency so 66. see discussion of proposals ofdavid cutler. roger lowenstein, the quality cure?, n.y. times, mar. 13, 2005, at 46. 67. see wisconsin collaborative for health care quality, available at http://www.wiqualitycollaborative.org (last visited feb. 2, 2006). 68. orly lobel, the renew deal: the fall of regulation and the rise of governance in contemporarylegal thought, 89 minn. l. rev. 342, 343-44 (2004). 69. see wisconsin collaborative, supra note 67. 70. wendy netter epstein, bottoms up: a toast to the success of health care collaboratives ... what can we learn?, 56 admin. l. rev. 739, 787 (2004). 71. thomas r. oliver, policy entrepreneurship in the social transformation of american medicine: the rise of managed care and managed competition, 29 j. health pol. pol'y & l. 701,713 (2004). these actors have the characteristics of the "policy entrepreneur," crucial to the implementation of these new routes. 2006] new governance and soft law in heal til care reform 153 the entire group accepts the value of collaboration·and views it as a way to achieve its own goals. the role of physicians is crucial in order for new governance to be successful in health care. historically, professionalism allowed physicians to mediate the tensions of a market--driven approach to health care and government regulation. professional values· and institutions were thought necessary for physicians to maintain an independent role. this worked for a period of time, however, business and consumer advocates complained that physician control resulted in higher costs, lack of access to care, and inconsistent quality of care. the managed care revolution in the 1980s and businesses' attempt to create a competitive market undermined traditionally professional institutions and controls, and physician leadership. the recent backlash against managed care, created in part by the actions of health care providers, has emboldened physicians to re-assert their leadership role. the managed care backlash came about in part by an alliance between physicians and consumers to fight the intrusion of "outsiders" into the physician-patient relationship. although physicians won this battle, managed care had changed the environment in which they practice through the development of large integrated hospital and clinic systems where most physicians now practice, the creation of evidence-based medicine, and increased reliance on allied health care professionals. as one observer noted, ''physicians ~weakened but not vanquished. •m in attempting to reassert their leadership role, physicians noted the effectiveness ofbusiness leaders in advancing quality in health care through the use of networks. they now emulate these network collaborations by working with a wide variety of stakeholders. although physicians are asserting a new role, the concerned employer­ payer, who emerged in the 1980s to control health care costs, is still active and prominent. since provision of health care coverage in the united states occurs significantly through the workplace, employers want to control health care costs as they are a major factor in their profitability and. sustainability. the pressures of the global economy require businesses to engage in global arenas that are not integrated into traditional sites. national competitiveness is being threatened by health care costs. some large companies can no longer pay for health care for their workers through their revenues. entrepreneurial companies cannot pay for health care as they "start up." this is why business leaders have joined the fight for universal coverage. alternative sites may encourage business reformers to launch the effort for universal coverage. in addition to the access problem, employers have expanded their activities to improving quality and even becoming active in solving the problem of the uninsured. 73 the leading voice of business in health care is the leapfrog 72. jillquadagno,physiciansovereigntyandthepurchasers' revolt,29j.healthpol pol'y & l. 815, 832 (2004). 73. miltfreudenheim, companies band together as a way to offer health care to part­ time employees, n.y. times, may 13,2004, atc3. 154 indiana health law revjew [vol. 3:137 group, a consortium of more than one hundred large employers that have mobilized to use their purchasing power to affect the health care system. the leapfrog group, while national, bas substantial influence on business actions at the state and local level. it exerts a major external force on the internal workings of health care institutions and professional groups through the production and dissemination ofbencbmarks on the quality and cost ofhealth care procedures. 74 these evolving collaborations, while often effective, face challenges. first, there are internal and external mechanisms that have to be refined in order for the process to achieve its goal there is also a reliance on regionalism, a level of government that has been of mixed success in the united states. finally, the ''publicness" of these collaboratives is often insufficient. there are internal mechanisms that affect the potential success of these collaboratives.75 the first is the internal interests of the stakeholder. for instance, physicians are not a monolithic group. surgeons and pediatricians may be threatened by some quality standards in different ways. 76 small businesses have interests and power that differ from than the fortune 500 companies. also, the success of the collaborative may depend on who within the organization is participating and their relationship with their constituency. for example, the participation ofthe head of a stakeholder organization may provide certain kinds of authority, but ifthe head ofthe organization cannot sell the collaboration to the rest of the organization, the goals of the collaborative may be undermined. these collaboratives contain internal costs that must be weighed against the benefits. these costs include the time that stakeholders invest in lengthy meetings and interactions. an additional cost is the money required to maintain an ongoing organization and to pay for staff. finally, the process may be slow, limiting flexibility, which is the raison d'etre of such collaboratives. 77 the external mechanisms that affect the success of the collaboration are transparency of collaboratives, dampening of potential innovation caused by fears of liability and existing inflexible regulations, and the absence of unorganized constituencies. state and federal administrative procedure acts and open records and open meetings laws do not apply to many of these collaboratives because they are not organized as public bodies. this makes the availability of information about their activities difficult to find and makes their work seem suspicious. however, the new american health information 74. see leapfrog, supra note 33. 75. john braithwaite et al., the governance ofhealth safety and quality, 27 fig.3 (2004) (unpublished manuscript, on file with author). 76. rachell callcut, the influence of private regulation on the practice of general surgery (dec. 6, 2004) (unpublished manuscript, on file with author). 77. a. bryce hoflund, an exploration of the costs associated with consensus making in healthcare (june 2005) (unpublished manuscript, on file with author). 2006] new governance and soft law 1n health care reform 155 community ("ahic") provides a collaborative to accelerate the application of health information technology. the collaborative developed by the department ofhealth and human services is specifically organized under the framework of the federal advisory committee aces in order to allow for open public meetings and ''widespread stakeholder participation in which everyone has a voice.'m in addition, fears of malpractice litigation may also be an obstacle to the development and implementation of innovative techniques. substantive government regulations that do not allow for innovative systems, such as payment for quality, are also external checks on the effectiveness of collaborations. a third external barrier is the difficulty of patient and consumer participation. these groups have traditionally had difficulty organizing due to their diverse income, race, ethnicity, gender, and geography. 80 regional groups are also mooted. in president george w. bush's proposals for disseminating new technology in health cares1 and in the medicare modernization act, 82 there is a commitment to regionalism, described as below the federal level but not necessarily at the state level. this is consistent with the academic discussion about "new regionalism" and "new localism."83 scholars note that in order to achieve the values of local autonomy there needs to be a legal regime that encourages local participation; limiting centralized power is not enough to create greater diversity and participation. some of the proposals now available cross states but are not geographically contiguous. for example, prescription drug pools now cross state lines. the i-save rx plan allows five non-contiguous states to develop a shared pool to purchase drugs for a lower cost 84 the states • locations range from the midwest to the east.85 the efficiency of this type of pooling comes from the ability to use one purchasing system to buy in bulk internationally and deliver the drugs via mail. 78. federal advisory committee act, 5 u.s.c.a. app. 2 (1972). 79. press release, office of the nat'l coordinator for health info. tech., questions and answers: american health infonnation community (june 6, 2005), available at http://www.hhs.gov/healthit/qa.html (last visited may 2, 2006) 80. john harley warner, grand narrative and its discontents: medical history and the social transformation of american medicine, 29 j. health pol. pol'y & l. 757, 769 (2004). 81. questions and answers am. health info. cmty., supra note 79. 82. see medicare modernization update, available at http://www.cms.hhs.gov/mma update/01_ overview.asp#topojpage(last visited may2, 2006) 83. davidj. barron, a localist critique of the new federalism, 51 dukelj. 377,432 (2001). 84. press release, ill. office of the governor, governor blagojevich & congressman emanuel joined by wis. governor doyle in launching 1-saverx prescription drug imp. program; citizens oflll. & wis. now able to purchase rx drugs from europe & canada (oct. 4, 2004), http://www.illinois.gov/pressreleases/pressreleaseslistsbow.cfm?recnum=3439 (last visited june 6, 2006). 85. ld. 156 indiana hbalrn law review [vol. 3:137 one striking aspect of the collaborations is the interaction of public and private arenas that can be seen in the emerging public/private partnerships. these collaboratives have various organizational forms that allow for flexibility. all of these sites need some form of "publicness." however, getting public and private interaction is not easy because efficiency and legitimacy are both needed. one obstacle to getting the interaction right is the lack of coordination between public law and private law. public law is embodied in administrative law and procedure whereas private law is contract, tort and property. each domain has a separate and robust history, expertise, and skill set however, if these emerging private partnerships are to work they must be composed of both public and private law. one model would be through contracts with public agencies where the services provided are subject to open meetings and open records requirements. 86 another technique would be through monitoring standards for these alternative sites by a credible organization. 87 it would be beneficial to have a period of experimentation for various models of ''publicness" accomplished through sharing models designed to exchange experiences and evaluate effectiveness. 88 various models are proposed in the debate over the ownership ofhealth data between providers and consumers. 89 b; consumer and patient participation one distinctive feature of new governance practices is the increasing and changing role of the patient and consumer. the patient and consumer are envisioned as independent actors who can influence outcomes at the clinical and policy level. the development of economic incentives such as co-pays and positive economic incentives are methods of the individual using his or her market power to improve quality of health care. the use of public information based on data that enable the consumer to make choices will both improve the quality of care and the entire system. these economic and infonnation incentives can be combined with methods of delivery encouraging 86. one example is the contract between the wisconsin department ofhealth and family services and the wisconsin hospital association to administer the data collection program for the state. 87. one example of this the work of the joint commission on accreditation ofhealthcare organizations (jcaho). see bludl, infra note 117 88. see cary coglianese, the internet and citizen participation in rulemaking, 1 info. soc. j.l. & pol'y 33 (2005) {discussing the tension between regulators and industry and transparency ofinteractions; pointing out that sometimes the public interest is advanced through informal communications that are not always visible to all). 89. one commentator has noted that if these decisions on ownership and availability are allowed to be, proprietary democratic values will be lost, and our society could be called a "banana republic." john chapin, health data in a banana republic {jan. 2005) (unpublished manuscript, on file with author). 2006] new governance and sofr law in health care reform 157 patients to participate in the management of their own care, particularly with connection to chronic illnesses. there is also an emphasis on consumer participation in the collaborative sites. the consumers ate considered essential to the :functioning health care improvement processes; the voice of consumers and patients is essential for deliberation. the voices of the consumers and patients can be provided through groups of consumers, such as disease groups, and lawyers who represent disadvantaged groups, including racial and ethnic minorities. in earlier periods physicians were relied on as the trusted agents for patients because physicians were the sources ofknowledge. physicians were also the major reformers of the health care system during the early twentieth century.90 during the great society period, consumers and patients partici­ pated in deliberation through public interest lawyer advocacy at the administrative agency, social movements at the legislative level, collective bargaining with employers, and litigation against discrimination and malprac­ tice.91 in the market model that emerged in the 1990s, consumers were some­ times viewed as creating costs unrelated to necessary care and were encouraged to join managed care organizations where decisions regarding the type and quantity of care were made by management. the rise of consumers as key players in health care is related to the use of markets in health care to controlling costs and the increase in patient involvement to control chronic disease. therefore, two consumer roles are important in health care: the role of the purchaser ofhealthcare services and that of the patient active in his own health care.92 after managed care, employer purchasers realize that more allies are needed to develop and implement any new healthcare system design. they view a strong consumer role as essential to any sustainable change to the system. they also believe that giving consumers a greater voice in the purchase and delivery of health care is essential to creating a cost-effective and high quality system. the interface of the longstanding patient rights vision with the newer patient empowerment movement opened the path to a more active role for patients/consumers in the level of clinical and institutional decision making.93 the initial move toward public disclosure, while led by business groups, now has the strong endorsetnent of traditional consumer groups such as consumers union. 94 consumers union has created a campaign called "stop hospital 90. joe rees, the origins of self-regulation in the american hospital industry (june 2003) (unpublished manuscript, on file with the author). 91. lawyering for a new democracy, supra note 51, at 584. 92. barry kozak, new health savings accounts promote consumer driven health care, 18 cba rec. 58, 59 {2004). consumer driven health care is advocated as encouraging both aspects of the consumer role. 93. sydney halpern, medical authority and the culture of rights, 29 j. healm pol. pol'y & l. 835, 842 (2004). 94. see consumers union, http://consumersunion.org (last visited may 2, 2006). 158 indiana healm law review [vol. 3:137 infection" to "help consumers get the best quality of care by promoting public disclosure ofhospital infection rates ... consumers and employers can select the safest hospitals and competition among the hospitals will quickly force the worst to improve.•>9s consumers union is endorsing the passage oflegislation to require the infection rates be made public. 96 the emphasis on patient self­ management has decentered the physicians and lawyers. the new governance legal forms also require a revised role for lawyers. the new governance processes incorporate all the stakeholders in order to develop a system that acknowledges and utilizes diverse knowledge. lawyers therefore can participate by representing their constituency and by developing processes and programs that work to improve the system. one example of a different role for lawyers is the quality approach in reducing disparities. the civil rights litigation approach embodied in title vi and hhs enforcement model were based on the lawyer as· the adversarial advocate for the patient. 97 in the quality assurance approach, the lawyer's role would no longer be as an advocate for the individual or institutions alleging discrimination by health care providers and payers. it would decenter the court as the main arena for redressing the harm that came from discriminatory conduct. the major emphasis is placed on reforming internal health care systems through a combination of creating incentives for positive outcomes and evidence-based medicine. employees and government payers would tie payment to quality outcomes, including compliance with outcomes that have a significant affect on preventing disparities. examples of such outcomes are good prenatal care, normal birth-weight babies, and proven chronic care management. therefore, the civil rights model, which is based on an adversarial lawyer and court complex, would no longer be the dominant model. the performance of physicians and the medical institutions, combined with carefully developed guidelines and benchmarks, would be the tools for reducing disparities. a concern about new lawyer roles is uncertainty about who will be the advocates for disadvantaged groups. while educated patients can be effective at the patient-physician level, representatives of the interests of the disadvantaged groups are essential at the institutional and policy level. the move to consumer-driven health care contains the idea that consumers and patients, if they are provided information or economic incentives, can influence the system as well as obtain better, less expensive care. the advocate's role in assisting patient participation can tie into the important 95. /d. 96. they have a model act "hospital infec:tion disclosure act" and are encouraging activists to argue for its passage. in some~ sponsors of the legislation include the hospital associations and patients and families who were infected. lawyers who brought the lawsuits on behalf of the patients are also involved. 97. marianne engelman lado, unfinished agenda: the needfor civil rights litigation to address race discrimination and inequalities in health care delivery, 6 tex. f. onc.l. & c.r. i, 16 (2001). 2006] new governance and sofi' law in health care reform 159 work done on negotiation and dispute resolution. the personal health record is one tool that is being promoted as a way for consumers to be in control, particularly in relation to their physician and health care institution. 98 these exercises teach the patient to operate on the patient/client, institutional, and policy levels. 99 many people cannot deal with the overwhelming number of choices. one example is the difficulties associated with the medicare plan for pharmaceuticals which is failing because of excessive information. 100 people often need information tailored to their own health history; people with chronic disease may need assistance in locating information on what programs provide intensive disease management. on the institutional and policy level, the knowledge required for intervention is often sophisticated and requires skills such as accessing institutional policies, locating statutes and court cases, and discovering the places where intervention will be useful. advocates for disadvantaged groups can be lawyers or reformist physicians committed to an all-inclusive health care system. these advocates play the role of assuring that barriers to access are removed. for example, they could ensure the collection of reliable data on the number and characteristics of the uninsured for program and policy development.101 these advocates may also play an important role in diffusing the liability debate that is a barrier to implementing the new quality tools. they could advocate for the creation of monitoring institutions that assure that abusive and negligent behavior is prevented or sanctioned.102 c. disaggregated but necessary: the role of government the new deal view of government as the controlling, commanding presence is no longer accurate.103 it imagined that the social dimension of government should primarily be directed from washington through national legislation implemented through administrative agencies issuing uniform regulations. state and local governments, while still involved, had a subordinate role. in the 1980s, with the move towards confidence in market 98. connecting for health, http://www.connectingforhealtb.org. (last visited may 2, 2006). 99. david dominguez, getting beyond ya to collaborative justice: the role of negotiation in community lawyering, 12 geo. j. on poverty l. & pol'y 55, 59-60 (2005). 100. jane zhang, seniors are slow to sign up on own for drug benefit, w au. st. j., dec. 23, 2005, at b3. 101. donna friedsam, racial and ethnic data: are they reliable for program and policy development?, wis. pub. heal1h and health pol.inst., issue brief, no. 5 (oct. 2002) available at http://www.pophealtb.wisc.edu/uwphi/publicationslbriefs/oct02brief.htm (last visited june 6, 2006). 102. sage, supra note 4, at 402. 103. see tushnet, supra note 42; william h. simon, solving problems v. claiming rights: the pragmatist challenge to legal liberalism, 46 wm. & mary l. rev. 127 (2004). 160 indiana healmlaw review [vol. 3:137 based incentives as the means to provide health care improvement, the confidence in external government regulation declined; however, in the recent discussions about governance, the role of government is seen as necessary~ even though it may no longer be the authoritative directing agency as envisioned in the traditional command and control model.104 traditionally, the government's primary role has been fiscal through the public budgetary process.105 through its fiscal capacity, the state can align various private players with public policy goals. it can use this power to play disaggregated roles: enactor of innovative regulation, crucial funder, active monitor, final sanctioner, orchestrat0r, and justifier of programs. the states' participation in the collaboratives, for example, is essential to ensure that health care services, even if privatized, are fair, equitable, and effective. the government assumes a coordinating role in the implementation ofhealth care services and organizes activities so that each actor can do whatever it does best. the various ways in which government can be involved include facilitating collaboration, monitoring programs for effectiveness, collecting data, using regulation and funding to assure quality, correcting imbalances in participa­ tion, and sanctioning to ensure that actors participate in good faith. d. new corporate forms there is also a change in the governance of hospitals. the existing governance structures cannot cope with pressures such as pay for performance regulations, benchmarking for quality care, and embedding technology. hospitals are considering a wide range of redesigns of their systems in order to be able to deal with these external pressures. hospitals are considering coordinating with other health care organimtions, using industry based regulatory systems such as iso 9000, placing more responsibilities to meet public goals on boards of directors, and creating a systems approach to liability. 106 as hospitals and clinics become larger integrated systems, there is also a move towards standardization ofbenchmarks and improved internal communication. this requires lawyers and compliance people to agree on systems in order for the information to be produced over the entire range of institutions and people responsible for institutions. thus, we see a crossing over· between all institutions necessary to demonstrate value for the compensation to be paid therefore, the governing system requires more 104. see mark schlesinger, on government's role in the crossing of chasms, 29 j. healtiipol.pol'y&l.1 (2004);seealsotroyena.brennan&donaidm.berwick,new rules: regulation, markets, and the quality of american health care (1996). 105. carolyn ·hughes tuohy, agency, contract, and governance: shifting shapes of accountability in the health care arena, 28 j. healm:pol. pol'y & l. 195,210 (2003). 106. sarah kaput, expanding the scope of fiduciary duties to fill a gap in the law: the role of nonprofit hospital directors to ensure patient safety, 38 j. realm l. 95, 102-03 (2005). 2006] new governance and soff law in health care reform 161 collaboration and interaction and undercuts the board of directors in a single institution. one way to achieve this goal is for lawyers and compliance professionals to work together to develop standards. 107 what is emerging in new governance is a blurring of the boundaries among for~profit institutions, large health care nonprofit organizations, and community-based agencies. the new collaborative sites include multiple actors from different organizational structures. these collaborations can orchestrate new ways of delivering health services and improve quality of services. useful tools include learning from each other, sharing of data, and the dissemination of peer benchmarks. through this process, there can be a reconsideration of the traditional legal forms. the reassessing of nonprofit hospitals as a source of assistance and funding for expansion of access is one example of what the collaborative action may create. there have been longstanding charity care pools that exist in many states serving as sources of funding to meet the health care costs of uninsured people. these programs have been routinely criticized as being insufficiently integrated with the health care delivery system and with the individual needs of clients. 108 there is also a charitable requirement for nonprofit hospitals. this requirement has been poorly monitored by the government and insufficiently integrated with the health care needs of the uninsured. recently, class action lawsuits have been filed across the country against hospitals for their failure to provide services to the uninsured. these lawsuits, while largely unsuccessful, have forced hospitals to consider how they link their service for the uninsured to their organizational status and to their community outreach. 109 in utah, former governor leavitt initiated integrating hospital charitable programs into the medicaid program. this represents an example of public­ private integration and orchestration discussed earlier. it is a redesign of the corporate form, where the state's interest is expressed, not only through the corporate non-profit law and the attorney general's authority to intervene in charities, but through the government directly working with the boards of directors in a common mission. the federal government is significantly increasing its funding for community based health centers because of their excellent record for providing equitable, quality care for poor and marginalized groups. its services can be put together with large for-profit insurers and large nonprofit hospitals and clinics to contribute to a funding 107. barry p. chaiken, address at the digital healthcare conference (june 9, 2005} (transcript on file with author). 108. elisabeth benjamin & kat gabriesheski, the case for reform: how new york state's secret hospital charity care pool funds fail to help uninsured and underinsured new yorkers, 8 n.y.u. j. legis. & pub. pol'y 5, 8-9 (2004-05). 109. charles f. sabel & william h. simon, destabilization rights: how public law litigation succeeds, 117 harv. l. rev. 1015, 1018 (2004); guy boulton, uninsured get more discounts, milwaukeej. sentinel, may 16,2005, atal 162 indiana health law review [vol. 3:137 package that will be administered by the participating groups; this allows for a variety of groups to do what they do best and also allows for structural monitoring and review of the dollars in the ''deal."110 · e. alternative dispute resolution the disillusion with traditional litigation has been ongoing for several decades. the high costs, unequal access to lawyers, and poor fit between the social problem and the results of litigation has engendered a series of proposed reforms. these proposed reforms move toward new types of redress, reduced use oflawyers, and improved health care outcomes. two additional types of dispute resolution are emerging as part of changing governance. the first is independent external review, a dispute resolution system for health care contract claims. this system developed out of dissatisfaction with the managed care system and is a way of reasserting physician peer review and curbing excesses in cost containment. the system, now enacted in almost all states, is primarily a paper review and almost eliminates lawyers from the system. the external review process is created through legislation but it is administered by private organizations certified by the state. these external review organizations use peer reviewers with very specific knowledge about the subject of the complaint. as one scholar notes they have a "structural hybridity, a discursive marbling of demands for democratic control over profit-driven health care services together with calls for responsiveness to medical expertise . . . a renegotiation of the role of government, not a simple contraction or expansion."111 there is also a relationship between the complaints and improvement in the quality of the healthcare plan. the information obtained from the complaints received and the decision of the review body can be accessed by the government agency and the health care plan and this information can be evaluated and utilized in improving the quality of the health services. public disclosure of the complaints and their resolution is another important component that can encourage systemic changes within the health care plan. 112 a second type of dispute resolution system is a version of restorative justice. the traditional command and control regulatory system relies on inspection, regulation, and sanctions. for many health care facilities that are financed through government payments, there is a narrow range of financial viability. the use of fines as deterrence is not viable since the facilities, 110. see john d. colombo, the failure of community benefit, is heal1hmatrix 29, 62 (2005) (discussing proposal for an access based test for nonprofit hospitals to justify their tax-exempt status). ill. nan d. hunter, managed process, due care: structures of accountability in health care, 6 yale j. healm pol'v l. & ennes 93 (2006). see also rachel tanner, health insurance oversight, hpts issue brief 015010.3, oct 10, 2005. 112. hunter, supra note 111. 2006] new governance and sofr law in healm care reform 163 particularly nursing homes, are barely making it, and a failure will leave the state with the burden of relocating residents. thus, as the push for high quality nursing homes continues, there is a need to come up with other means of correcting poor quality that does not involve heavy fines. in the restorative justice model, family members, residents, and if possible community and advocacy groups, meet together to discuss the problem and come up with a plan for improvement. this is a first step prior to the institution of the traditional regulatory sanctions.113 f. new regulatory tools another set of tools might be described as hitting the physicians and hospitals in their wallets and their egos. these three regulatory tools can be called: public information, financial incentives tied ·to efficiency, and regulations that allow the institutions to develop diverse ways of successfully meeting the standards. there is widespread development of data about outcomes and commitment to protocols. participation by physicians and other health care professionals is required in the development of standards and benchmarks for credibility. this information is sometimes collected by clinics, hospitals, and physicians and is often posted and accessible to all via the internet. these tools are different than traditional regulation. instead of rigid requirements issued after great debate, but often not revisited for many years, these systems are designed to be constantly updated and reviewed. this information can affect performance through shaming and motivates the institutions to develop systems that obtain results. by gathering data and updating results on a regular basis, there is a constant reinforcement to improve performance. another approach to improving performance is to align the incentives by tying financial payments to quality 114 one commentator recently noted that ''value for dollar" is now the game in health care. m a third approach may be referred to as management-based regulation. 116 management-based regulation is a mechanism that "directs regulated entities to engage in planning processes, that are self determined, to meet a particular public goal. "117 unlike technology-based and performance-based regulations, 113. braithwaite. supra note 75. 114. judith h. hibbard et al., hospital petformance reports: impact on quality, market share, and regulation, 24 health.aff. 1150, 1159 (2005). 115. dave riemer, address at univ. of wis. med. sch., apr. 4, 2005 (transcript on file with author). 116. cary coglianese & david lazer, management based regulation: prescribing private management to achieve public goals, 37 l. & soc'y rev. 691, 691 (2003). 117. john d. blum, combating those ugly medical errors-its time for a hospital regulatory makeover! (june 2005) (unpublished manuscript, on file with widener university law review). 164 indiana heal'ih law review [vol. 3:137 management-basedregulation is focused on planning. 118 here again medicare is taking the lead through the implementation of a quality assessment and performance program to reduce medical errors which is part of the broader medicare conditions of participation. it is a planning model that is designed to allow hospital flexibility in initiating new programs. 119 medicare has recently invested heavily in collecting quality data and publicly disseminating such information. it has also been active in encourag­ ing groups of stakeholders to develop benchmarks and indicators to be used for the comparisons. however, there is still an ongoing debate about how effective economic incentives and public data dissemination are in motivating providers. one issue is whether the data should be used to encourage internal systems reform by sharing the data exclusively within the organization, such as hospitals and physician practices. an alternative approach would be to publicly publish the data by individual hospital or physician to encourage consumer choice. the proponents of public dissemination see that option as "a social movement wrapped in a business model."120 there is also an issue of publicness of the process of data collection and dissemination. if the collaborative sites that are producing and disseminating the information are not adequately transparent, the process could become insular and self­ protective. one commentator has said that the control of the data and its dissemination requires adequate .public oversight; otherwise our democracy has become a "banana republic."121 iv. coexistance: dynamic between old and new, orchestrating multi-pronged strategies, and integrating legal values these three stories about resolving health care problems are descriptions of works in progress. as the reforms proceed, two questions emerge. the first is the question of how and whether new governance and soft law relate to the existing regulatory system. the second question is whether the innova­ tions that are emerging can reform health care while assuring participation, fairness, equity and accountability. there are three examples of coexistence between old governance/hard law and new governance/soft law in health care stories. the first is dealing with medical error, where old and new models coexist as alternatives and potentially as rivals. the second is where a government agency takes on the whole range of new governance techniques and employs them as part of its regulatory and funding functions. an example of this is the medicare program of the centers for medicare and medicaid services. the third route is the ll8. coglianese & lazer, supra note 116, at 691. ll9. see blum, supra note ll7. 120. markxistrass, address at colloquium on health cafe data collection and reporting (feb. 7, 2005) (transcript on file with author). 121. chapin, supra note 89 .. 2006] new governance and soft law in health care reform 165 integration of traditional legal values as part of the new governance approaches: monitoring to ensure participation, assuring commitment to eliminating discrimination through maintenance of equal protection, and linking the right to health care to the achievement of a robust economy. a. dynamic between old and new coexistence between new governance and soft law and the traditional hard law can occur through a dynamic rivalry. one example of the interrela­ tionship between the two is the effort to move from the traditional medical malpractice and administrative sanctioning of physicians to a systemic increase in quality. 122 the old governance system relied on medical malpractice and administrative physician sanctioning to guarantee quality and compensate injured parties. however, the existing malpractice legal structure is now a barrier to the development of a new framework that gets physician buy-in, adequately compensates patients for poor medical outcomes, and creates systemic processes to avoid medical errors. there is widespread agreement that the malpractice litigation system fails to compensate injured parties and to deter future negligence. proponents of the quality assurance system assert that it will do a better job of deterring negligent behavior as well as preventing unnecessary errors. 123 however, there is not yet a consensus as to how to compensate patients who are injured through negligent or non­ negligent behaviors. many alternatives on how to compensate patients who are injured have been proffered such as no-fault insurance, enterprise liability, or new types of redress such as medical courts or arbitration. 124 b. orchestrating multi-pronged strategies in some cases there is coexistence between a traditional government agency and new governance techniques where they are yoked in a multi­ pronged strategy that deals with complex problems. orchestration is one example of a multi-pronged strategy. it uses new governance techniques to integrate new knowledge, encourage innovation, and allow for diversity. the government agency, however, relies on its traditional regulatory and funding 122. see michelle m. mello et al., fostering rational regulation of patient safety,30 j. health pol. pol'y & l. 375,411 (2005) (discussing the tension between tort law and other regulatory approaches citing this area as one ofthe structural issues for what they call rational regulation). 123. see sage, supra note 4. 124. paul c. weiler, fixing the tail: the place of malpractice in health care reform, 41 rutgersl. rev. 1157, 1185 (1995). 166 indiana health law review [vol. 3:137 roles to provide baseline incentives for participation in the new governance processes. 125 the role of the center for medicare and medicaid services ("cms") is a dramatic example. cms is embarking on a multi-pronged strategy to improve quality and contain costs using new governance techniques for medicare. it is currently funding pay for performance pilot projects throughout the country that may be the basis for future widespread use.126 the pay for performance criteria will be used as a condition of participation for hospitals seeking to receive medicare reimbursements. it is creating forums for deliberation and action for quality improvement. for example, the hospital quality alliance is a public-private partnership designed to produce published consumer information coupled with health care quality improvement. 127 cms recently required the submission of hospital quality data as a condition of compliance in order to receive medicare funding; 128 this data is now displayed on a website.129 they have initiated other substantial publication of consumer information starting with comparative nursing home qualityindicators.13° cms initiated a discussion among many stakeholders on how medicare information can be used by beneficiaries in medical health records. it is one of several initiatives put forth in response to "president bush's call for americans to access their health records electronically within ten years. " 131 c. integrating legal values the new deavgreat society model for governance emphasized the need for universal "rights," based on constitutional or statutory law. the function of rights can be seen as coexisting with new governance modes. this coexistence can be seen in the way traditional legal values must be maintained in order for new governance to be effective and legitimate. three approaches to health care reflect the coexistence of these new governance techniques with 125. melloetal. termthisformofcoexistence"plmalisticregulatoryenvironment." mello et al .• supra note 122 , at 381. 126. press release, center for medicare and medicaid services. medicare "pay for performance (p4p)" initiates (jan. 31. 2005), http://www.cms.bhs.gov (follow "newsroom•• hyperlink, then "media release search") (last visited june 6. 2006). 127. marybethfarquhar,newgovernanceinhospitalqualitylmprovement: thehospital quality alliance (june 2005) (unpublished manuscript, on file with author). 128. id. 129. see hospital compare at http://www.hospitalcompare.bhs.gov (last visited may 2, 2006). 130. nursing home compare, http://www.medicare.gov/nhcomparelhome.asp (last visited may 2, 2006). 131. summary report, center for medicare and medicaid services. summary ofresponses . to an industry rfi regarding a role for cms with personal health records. http:/lwww.cms.bhs.gov/educationmaterials/downloads/summaryofrfi.pdf(lastvisitedjune 6.2006). 2006] new governance and soft law in health care reform 167 legal values: inclusion in universal access, equity in health care treatment, and participation and transparency in health care decision making. 1. inclusion the long-standing battle for a "right to health care" underlies many of the campaigns for universal provision of health care coverage. the failure to achieve a constitutional right for universal coverage was a major disappoint­ ment of the 1960s and 1970s ''war on poverty." more recently, the entitlement to medicaid coverage, a partial type of"right," was seriously threatened in a congressional battle and many of the new programs do not have entitlements. 132 the elimination ofthe entitlement status ofthe major welfare program for poor people-aid for dependent children ("afdc")-was a tremendous blow for the progressives who, since the new deal, had dreamed of the adoption of the european "social citizenship" model.133 the main­ tenance of the entitlement to medicaid is a continual battle. the battle over entitlements, coupled with the clinton plan failure, undermined the progres­ sive belief that an entitlement/rights approach was a likely route to universal coverage. constitutional approaches have proved ineffective and recent court decisions have further undermined the court-constitutional approach. what is needed is a conceptualization of the relationship between hard law entitlements with soft law techniques such as experimental expansions of coverage and linking private employer based programs with public coverage. 134 the merger of public and private programs is a way of achieving universal coverage where the poor will not be targets of inadequate funding and poor quality. in the access area, the importance of a commitment to universality continues. recent proposals have indicated a wider base of support among business and conservative legislators for universal coverage based on the "business case."l3s some type of hard law commitment may be a necessity to keep the attention on the importance of universality. but, a right is not sufficient if there is inadequate care and excessive patient payment contribution. 136 recent state battles over maintaining medicaid expansion programs have demonstrated the conflict between court mandates and the 132. sara rosenbaum et al., public health insurance design for children: the evolution from medicaid to schip, 1 j. health & biomedical l. 1, 4 i (2004). 133. joel f. handler. social citizenship and workfare ln the united states and western europe: the paradox of inclusion l-19 (cambridge univ. press 2004). 134. see tamara k. hervey, the european union and the governance of health care, law and new governance in the european union and the united states (de burca & scott eds., hart pub. 2006). 135. pam belluck, massachusetts sets health plan for nearly all, n.y. times, aprils, 2006, atal. 136. rosenbaum, supra note 132, at 41. see also, bill j. wright et al., the impact of increased cost sharing on medicaid enrollees, 24 health aff. 1106 (2005). 168 indiana realm law review [vol. 3:137 more flexible non-entitlement approaches.137 if the standards are not enforceable, there will be a tendency to cut back when funding is tight. the recent budget battles have demonstrated a strong commitment to expanded health care by governors on a bi-partisan basis. but the :fragility of the expanded programs demonstrates that a combination of diverse state programs, that merge public and private coverage, has to be incorporated into a :framework that allows for court and public scrutiny. 2. equity there are major initiatives underway to reduce disparities in race and ethnicity, but the role of rights is decentered in the new approaches. there is reliance instead on quality tools such as benchmarking, nationally accepted protocols for best practice, and patient self-management to eliminate disparities. preliminary results show that these processes may be effective in reducing racial disparities. the move to using the law of quality compliance includes soft law instruments such as benchmarking, data collection, and reporting.138 however, the law of civil rights can be combined with the law of quality compliance. the quality compliance techniques require collection of data and a commitment by the providers and institutions to collect, examine, and utilize the data. they also require a sharing of information across local groups and at the state and national level. community and patient participation in the system for quality are required for the protocols to be successful in order for there to be confidence that the standards and protocols are being followed, there must be an ability to monitor the work of institutions, such as hospitals and clinics. the civil rights community has maintained an interest in health care and the potential for legal remedies remains. its role can include ensuring that public data dissemination is available and usable by outside groups. specific monitoring systems can be set up, at the community level, the state level, the self-regulatory body level, or the national level. without these checks it is difficult to monitor that the techniques are in place and effective. once new governance techniques show positive results, it will be possible to use litigation to pressure health care providers to adopt the new processes. in that way, the simultaneous presence of anti-discrimination law and new quality improvement processes may make possible progress not previously achievable. 137. see bureau of tenncare, available at http://www.tennessee.gov/tenncare/ newslindex.html (last visited june 6, 2006). 138. sararosenbaum,symposium,racialandethnicdisparitiesinhealthcaretreatment (may 18, 2004) (unpublished manuscript, on file with author). 2006] new governance and soft law in healtii care reform 169 3. participation and transparency the values of participation and transparency are essential for a democratic system of governance. the process is likely to lose legitimacy if important and affected groups are left out of the process due to exclusion or lack of information. this may mean that special efforts must be made to ensure participation of underorganized and underrepresented groups, as well as organized groups. one approach to ensure participation is providing a system for explicit measurement of the participation of disadvantaged groups in these new sites. 139 this requires guidelines for participation and monitoring to ensure that the guidelines are being met. another approach is to provide a process where groups who view themselves as excluded from the process can challenge the transparency and effectiveness of the governance scheme. a final approach would be to develop a process where actors who are refusing to collaborate in these new alliances are sanctioned. some type of sanctioning might be necessaryto provide the incentives for participation. in order to be legitimate, the processes must be visible and accountable. the sites for deliberation, crucial elements in new governance decision making, should allow their work to be visible to interested parties. the problems involving access to electronic records raise important issues, such as the control of valuable social information. the interest in personal health records raises intriguing questions about the availability of the information and the interaction between the patient and the health care institutions. the coexistence of the need for flexible public private spaces and information must be balanced with the ability to hold the actors accountable for their outcomes. 140 conclusion this is an interesting time to look at alternative governance in health care. it is an opportunity to explore the implications of these alternatives and evaluate which types of regulation and governance work most effectively to achieve health care goals. many innovations challenge conventional institu­ tions, roles, and professions. they also challenge the way people participate in society and our view of how government and law can operate. many questions remain including the relationship of the new techniques to the older system. however, since the health care industry is one of the most significant sectors affecting the lives of every person as well as the productivity and growth of the economy, examining alternatives is a worthwhile endeavor. 139. brandon l. garrett & james s. liebman, experimentalist equal protection, 22 yale l.&pol'yrev. 261,321 (2004). 140. patricia flatley brennan, address at the digital healthcare conference (june 9, 2005) (transcript on file with author). strained application of the viability standard to in vitro frozen embryosdeconstructing jeter v. mayo clinic arizona brock j. heathcotte, esq.* table of contents i. introduction ......•••..•••.•.•••••..••..•••••...••.••.....•....•..•..••..•..•.................... 251 ii. how the issue of when a human life begins arises in court ............................................................................................ 253 iii. a brief history of relevant arizona law ............................... 255 n. the jeter case ................................................................................. 258 a. facts and holding ..................................................................... 258 b. pre-embryos were not viable .................................................. 260 c. evidentiary issues ..................................................................... 268 d. science and law ....................................................................... 272 v. conclusion ........................................................................................ 274 i. introduction american courts typically examine the best available scientific evidence relevant to a controversy before arriving at a decision. this evidence normally comes not only in the form of expert testimony in trials but also as extra­ judicial scientific treatises utilized by courts of appeal. 1 most courts, however, remain unwilling to utilize the best available evidence in developmental biology when deciding cases that require a decision about when a human life begins. while judicial opinions often describe some aspects of embryonic biology and fetal life, courts usually fall back on legal precedent such as the viability stan­ dard popularized by abortion law instead of using the most relevant scientific evidence to arrive at a decision about when a life begins. many complex legal circumstances arose in the past which seemed to re­ quire for their resolution a definition of when human life began. the current * ph.d candidate, 2007, arizona state university, tempe, arizona; j.d., 1990, arizona state university, tempe, arizona; b.a., 1987, university of arizona, tuscon, arizona. the author wishes to gratefully acknowledge the editorial comments of manfred laubichler, ph.d., j. alan rawls, ph.d., jason s. robert, ph.d., and the professional editing ofbarbara a. grant. 1. see kenneth culp davis, an approach to problems of evidence in the administrative process, 55 harv. l. rev. 364, 402 (1942) (providing a widely regarded, scholarly legal dis­ cussion of sources of evidence). 252 indiana health law review [vol. 5:251 and future science of reproductive technologies such as stem cell and human embryo research, in vitro fertilization, and the potential for artificial wombs, calls into question the judiciary's continuing reliance on standards from a prior technological age that were devised for socially pragmatic reasons at the time. it will soon be necessary for courts to re-examine when a human life begins in order to clearly articulate a sustainable legal strategy for dealing with the earli­ est stages of human biological development that has been more clearly illumi­ nated by scientific advances. while each judge is entitled to consider the implications of scientific practices in the context of each specific case before the court, a new era now exists where the decision provided should include a concerted effort to balance legal precedence with the evidence provided by new reproductive technologies. this idea is shared by supreme court justice ste­ phen breyer, albeit in a more general context: i believe there is an increasingly important need for law to reflect sound science, and i remain optimistic about the likelihood that it will do so. it is common to find co­ operation between governmental institutions and the sci­ entific community where the need for that cooperation is apparent. today, as a matter of course, the president works with a science adviser, congress solicits advice .. . from the national academy of sciences, and the scien­ tific regulatory agencies will often work with outside scientists, as well as their own, in their efforts to develop a work product that reflects good science. 2 for decades courts have avoided deciding when life begins. but, if we take justice breyer's comments seriously, the time has come for the legal system to take a more complete and informed decision about defining human life based on the best available science. recently, in the case of jeter v. mayo clinic arizona, one court undertook this challenge to define human life based on some aspects of developmental biology, but failed to use this analysis for any legal purpose. 3 while the jeter court managed to avoid controversy without applying the relevant science, it failed to address the issue of great importance posed by the case-were cryo­ genically preserved human embryos living human beings whose lives are pro­ tected by law? the jeter court's reluctance to answer the fundamental legal 2. stephen g. breyer, the interdependence of science and law, 82 judicature 24, 26 (1998-1999). 3. jeterv. mayo clinic arizona, 121 p.3d 1256, 1256 (ariz. ct. app. 2005). the case is still pending trial in superior court. however, the question of importance to this paper, whether a wrongful death claim for loss of frozen embryos was allowed under arizona law, has been resolved in the negative. 2008] deconstructingjeter v. mayo clinic arizona 253 question posed by advancing technological proficiency in manipulation of hu­ man embryos was justified by passing the question to the arizona legislature. legislatures have not been as reluctant to take a position on when life be­ gins and have in many instances enacted laws protecting human life from con­ ception.4 further complicating this discussion, at least one court appeared willing to allow a jury to decide when life begins before being reversed on ap­ peal.5 this development will likely make the application oflegal rules in this area less coherent and will create further ambiguity in defining when life be­ gms. ii. how the issue of when a human life begins arises in court appeals were filed with the illinois6 and south dakota7 courts that will further define the parameters oflegal protection for human embryos. each case followed a different path to arrive at the same question-when does a human life begin? the cases were brought as a claim for wrongful death in illinois, and as a request for an injunction to prevent enforcement of an abortion law in south dakota. the question of when life begins has also arisen in cases brought as medical malpractice, civil accident/injury torts, and as criminal pros­ ecution.8 these various forms of cases arise under common law, statutory causes of action, and beg additional constitutional questions. various state courts and legislatures have arrived at different standards for recognizing when a human life begins in each of these legal contexts. 9 even within individual states, the 4. unborn victims ofviolence act, 18 u.s.c. § 184l(d). 5. see acuna v. turkish, 894 a.2d 1208 (n.j. super. ct. app. div. 2006), rev'd, 930 a.2d 416 (n.j. 2007). the new jersey court of appeals ruled that a jury should decide whether an abortion physician must tell his patient that her six to seven week old embryo was a distinct living individual. acuna sued turkish for lack of informed consent and severe emotional dis­ tress upon discovering after the abortion that her unborn child was more biologically developed than she was led to believe. however, the court of appeals was reversed by the new jersey supreme court. 6. see miller v. am. infertility group, no. 02-l-7394 (circ. ct. cook county, ill., feb. 4, 2005) (ruling that a cryopreserved human embryo lost by the fertility clinic was the proper subject of a wrongful death lawsuit because the frozen embryo fit within the legislature's defi­ nition of human being. the case is on appeal to the illinois court of appeals). 7. see planned parenthood v. rounds, 467 f.3d 716 (8th cir. 2006) (ruling that an in­ junction was appropriate against enforcement of a south dakota law that required abortion pro­ viders to tell patients, among other things, that "the abortion will terminate the life of a whole, separate, unique, living human being," in order to satisfy informed consent laws). after south dakota voters rejected an abortion law in a november 2006 referendum, the decision was va­ cated and a rehearing en bane was granted. 8. bonbrest v. kotz, 65 f.supp. 138 (d.d.c. 1946) (medical malpractice); dietrich v. inhabitants ofnorthampton, 138 mass. 14 (1884) (slip and fall); people v. davis, 872 p2d. 591 (cal. 1994) (feticide). 9. for different state treatments of the status of embryos and fetuses, see alan s. wasser­ strom, annotation, homicide based on killing of unborn child, 64 a.l.r. 5th 671 ( 1998); annotation, liability for child's personal injuries or death resulting from tort committed 254 indiana health law review [vol. 5:251 standard definitions applied by courts under common law, legislatures by stat­ ute, and the federal courts by constitutional law are often varied. for example, the legal definition may be phrased in terms of the "personhood" of the embryo or fetus, or whether the embryo or fetus is a "human being," but in other in­ stances may be defined in terms of"potential" persons or human beings. many states tend to use the term ''unborn child" as a generic term for the embryo and fetus in the womb. 10 many other scientific and unscientific terms have also been used which further diminish the specificity with which a unified legal de­ finition can be constructed. given the various standards that exist for defming life from the point of conception through to birth and with the complex legal standards established by single institutions within a single state who have ar­ ticulated several different standards over the past fifty years, 11 the result is a legal maze through which abortion providers, fertility clinics, and human em­ bryo researchers must navigate with legal uncertainty.12 this article will examine the confounding issue of defining life by pri­ marily examining the language codified in arizona legislation and by reviewing recent case law, particularly the case of jeter v. mayo clinic arizona.13 the primary focus will be to analyze two issues; who should decide the ultimate question of defining life and how to determine the level and type of evidence required to facilitate the decision. two quotes illustrate the starting point from which to begin this discussion. first, a statement from the jeter opinion where judge donn kessler opined "[c]urrent scientific knowledge concerning em­ bryonic development underscores the difference between a viable fetus in vivo and an eight-cell, three-day-old pre-embryo in vitro. such knowledge is impor­ tant to help guide, but not dictate resolutions of the problem."14 second, a quote from a book written by dr. jane maienschein of the arizona state uni­ versity school of life sciences, who was often cited in the jeter opinion, against child's mother before child was conceived, 91 a.l.r.3d 316 (1979); sheldon r. sha­ piro, annotation, right to maintain action or to recover damages for death of unborn child, 84 a.l.r. 3d 411 (1978); roland f. chase, annotation, liability for prenatal injuries, 40 a.l.r. 3d 1222 (1971 ). 10. see ariz. rev. stat. ann.§ 13-1102-1105 (arizona homicide statutes). 11. the evolving judicial interpretation of the word "person" in the illinois wrongful death statute is a prime example. see amber n. dina, wrongful death and the legal status of the previable embryo: why illinois is on the cutting edge of determining a definitive stan­ dard for embryonic legal rights, 19 regent u. l. rev. 251, 251 (2006-2007); millerv. amer­ ican infertility group, no. 02-l-7394 (circ. ct. cook county, ill., feb. 4, 2005); smith v. mercy hospital, 560 n.e.2d 1164 (ill. app. ct 1990); green v. smith, 377 n.e.2d 37 (ill. 1978); chrisafogeorgis v. brandenberg, 304 n.e.2d 88 (ill. 1973); amann v. faidy, 114 n.e.2d 412 (ill. 1953); allaire v. st. luke's hospital, 56 n.e. 638 (ill. 1900). 12. federal and state regulation and funding rules for embryo research are more immedi­ ately pertinent to researchers, but this paper focuses on the ultimate question that is answered by law rather than regulation. it does a research facility no good to have funding lined up for hu­ man embryo research, and all the mechanisms in place to perform the research, if the state it is located in is prepared to prosecute for manslaughter when the research actually begins, or if the embryo progenitors are allowed to sue the facility for wrongful death of the embryos. 13. jeter v. mayo clinic arizona, 121 p.3d 1256 (ariz. ct. app. 2005). 14. jeter, 121 p.3d at 1265 (citing maienschein, infra note 18, at 10). 2008] deconstructing jeter v. mayo clinic arizona 255 "[e]ach stage of a developing individual is alive, but we might well decide that the earliest stages do not yet meaningfully count as a life." 15 these statements give rise to additional questions this paper will attempt to address. is the science cited by courts and legislatures "good" science? whom does science guide and through what mechanisms? who is the "we" that must decide what counts as a life? and finally, is the existence or nonexis­ tence of a human life a question of fact or law? ill. a brief history of relevant arizona law arizona currently has a confused but typical statutory scheme for protec­ tion of the human embryo and fetus. 16 adding to this complexity, arizona courts changed their interpretations of those statutes in recent years.17 further­ more, in arizona, there is a constitutional provision preserving the right to civil actions. 18 so, for example, if an unborn child is injured while in the womb, the unborn child is afforded the right to sue for compensation at any time after birth but prior to reaching the age of majority plus the applicable statute of limita­ tionswhich normally means up to the age oftwenty. 19 if the unborn child dies before birth, survivors may bring an action for the unborn child's wrongful death but only if the injury occurred after the unborn child reached viability. 20 however, someone who causes the death of an unborn child at any stage of de­ velopment is susceptible to prosecution and punishment under criminal statute with the exception being abortion which is legal under federal constitutional law. under the current arizona statutory scheme, the crime of manslaughter is a class two felony when an individual causes the death of an "unborn child" at 15. jane maienschein, whose view of life? embryos, cloning, and stem cells (harvard university press) (2003) [hereinafter maienschein] (dr. maienschein is on this au­ thor's ph.d. dissertation committee.). 16. see, arlz. rev. stat. ann.§ 13-105(26), § 13-1101(3), § 13-1102-1105, § 13-604, § 13-604.1, § 13-702-703.1, § 12-502, § 12-542 (2007); see also ariz. const. art. xviii, § 6; ariz. rev. stat. ann.§ 12-611 (2007); state v. hampton, 140 p.3d 950 (ariz. 2006); state v. cotton, 5 p.3d 918 (ariz. ct. app. 2000); vo v. super. ct. in & for county of maricopa, 836 p.2d 408 (ariz. ct. app. 1992); state v. amaya-ruiz 800 p.2d 1260 (ariz. 1990); larriva v. widmer, 415 p.2d 424 (ariz. 1966); kilmer v. hicks, 529 p.2d 706 (ariz. ct. app. 1974); sununerfield v. super. ct., 698 p.2d 712 (ariz. 1985); burnham v. miller, 972 p.2d 645 (ariz. ct. app. 1998); jeterv. mayo clinic arizona, 121 p.3d 1256 (ariz. ct. app. 2005). 17. seethe changing interpretation of the word "person" in arlz. rev. stat. ann.§ 12611 (2007) by arizona courts in kilmer v. hicks, 529 p .2d 706 (ariz. ct. app. 1974); summer­ field v. super. ct., 698 p.2d 712 (ariz. 1985); jeter v. mayo clinic arizona, 121 p.3d 1256 (ariz. ct. app. 2005). i 8. ariz. const. art. xviii, § 6 ("the right of action to recover damages for injuries shall never be abrogated, and the amount recovered shall not be subject to any statutory limitation."). 19. no case has tested whether an unborn child can stand as a party plaintiff in an action. it is questionable whether such a case could come to decision because human gestation is faster than human litigation. on the other hand, a lawsuit filed on behalf of a cryogenically preserved embryo could get its day in court. 20. summerfield v. super. ct., 698 p.2d 712 (ariz. 1985). 256 indiana health law review [vol. 5:251 any stage ofbiological development which can range anywhere from the point of implantation to emergency birth precipitated as a result of an injury to the fetus's mother.21 however, the wrongful death civil statute22 speaks only of death of a "person," which has been interpreted by the arizona supreme court to include a stillborn fetus that is "viable." (of note, the court in this decision did not address earlier stages of development.23 therefore, under arizona law, for the first five or six months of a pregnancy the state can prosecute a wrong­ doer for violating the manslaughter statute in causing the death of an embryo or fetus, but the parents cannot sue the wrongdoer under the wrongful death stat­ ute for the same act. the manslaughter statute has been amended twice in recent times. in 1983, the addition of statutory language made it a crime to cause the death of an unborn child.24 in 2005, the legislature again amended the statute by adding additional language to clarify that a crime occurs only if the unborn child was "in the womb" at the time of the wrongful act.25 this condition may have been 21. ariz. rev. stat. ann.§ 13-ll03 (2007): a. a person commits manslaughter by: 1. recklessly causing the death of another person; or ... 5. knowingly or recklessly causing the death of an unborn child by any physical injury to the mother. b. an offense under subsection a, paragraph 5 of this section applies to an unborn child in the womb at any stage of its development. a person shall not be prosecuted under subsection a, paragraph 5 ofthis section if any of the following applies: 1. the person was performing an abortion for which the consent of the pregnant woman, or a person authorized by law to act on the pregnant woman's behalf, has been obtained or for which the consent was implied or authorized by law. 2. the person was performing medical treatment on the pregnant woman or the pregnant woman's unborn child. 3. the person was the unborn child's mother. c. manslaughter is a class 2 felony. 22. ariz. rev. stat. ann. § 12-611 (2005): when death of a person is caused by wrongful act, neglect or default, and the act, neglect or default is such as would, if death had not ensued, have entitled the party injured to maintain an action to recover damages in re­ spect thereof, then, and in every such case, the person who or the corpora­ tion which would have been liable if death had not ensued shall be liable to an action for damages, notwithstanding the death of the person injured, and although the death was caused under such circumstances as amount in law to murder in the first or second degree or manslaughter. 23. summerfield v. super. ct., 698 p.2d 712 (ariz. 1985). 24. see ariz. rev. stat. ann.§ 13-1103 (2007). from the 1983 amendment until the 2005 amendment, section a( 5) read, "knowingly or recklessly causing the death of an unborn child at any stage of its development by any physical injury to the mother of such child which would be murder if the death of the mother had occurred." 25. ariz. rev. stat. ann. § 13-1103 (2007). 2008] deconstructing jeter v. mayo clinic arizona 257 unclear from the wording ofthe statute prior to the 2005 amendment, particu­ larly for those interested in performing in vitro human embryo research. the legislature has not amended the wrongful death statute since 1939 and it remains essentially the same since territorial days.26 the courts, how­ ever, have changed their interpretation of the statute. in 1974, the arizona su­ preme court ruled in the case of kilmer v. hicks that a nine-month-old fetus who was overdue by two days was not a "person," as the term was used in the arizona wrongful death statute in relation to a pregnant woman who died along carrying a fetus in an automobile accident.27 the court noted that the majority standard among states was that one must be born in order to be legally recog­ nized as a "person" under the statute. 28 in addition, in making their decision the court was guided by the abortion case of roe v. wade which was decided the previous year.29 the arizona supreme court stated, "[w]e believe that the meaning of the word 'person' in the statute is clear and unambiguous in its non­ inclusion of a viable fetus. it is a matter for the legislature to expand the statu­ tory definition if it deems it appropriate and not a matter for this court.'.jo however, in 1985, the same arizona court reversed itselfby finding that a "viable" fetus was a ''person" within the meaning of the arizona wrongful death statute in the summerfield case.31 summerfield was decided only two years after the legislature changed the criminal law to punish for the crime of feticide as described above. in the decision, the court noted that the criminal statute was included in the section associated with the killing of''persons."32 in the eleven years between kilmer and summerfield, the majority of states changed their interpretation of"person" for wrongful death purposes to include a viable fetus, and arizona subsequently followed suit.33 26. ariz. rev. stat. ann. § 12-611 (2007). 27. kilmer v. hicks, 529 p.2d 706 (ariz. ct. app. 1974). 28. /d. 29. roev. wade,410u.s.l13, 158(1973)(afetusisnotapersonwithinthemeaningof the 14th amendment). 30. kilmer, 529 p.2d at 708. 31. summerfield v. super. ct., 698 p.2d 712 (ariz. 1985). baby girl summerfield was stillborn allegedly because of medical malpractice by defendants james colleen, m.d., and ri­ chard lott, m.d. the trial court dismissed the claim for wrongful death and the summerfields filed a special action seeking reversal of the judge's decision. 32. the statute, ariz. rev. stat. ann.§ 13-1103 (2007), expanded criminal protections to any stage of development, but the summerfield court was only presented with a case of a vi­ able fetus. it is regular practice for courts to resolve only the issue currently before them. the fetus in the summerfield case was viable. whether or not the summerfield court would have gone further to allow a wrongful death action to a non-viable fetus had they been faced with such a case is unknowable. 33. many states have identical wrongful death statutes that do not define "person." in all of those states, the courts have been forced to come up with a definition. most states have drawn a line at viability, but a growing number of states have expanded personhood in the wrongful death context even to the non-viable fetus or embryo, sometimes on the basis oflegis­ lative intent expressed in criminal statutes. see, ronald f. chase, annotation, liability for pre­ natal injuries, 40 a.l.r. 3d 1222 (1971); michael p. penick, annotation, wrongful death of fetus, 19 am. jur. proof offacts 3d 107 (2007); sheldon r. shapiro, annotation, right to 258 indiana health law review the majority rule, which now recognizes that a death ac­ tion will lie under the circumstances present here, ac­ knowledges that the common law has evolved to the point that the word "person" does usually include a fetus capable of extrauterine life. the majority also recog­ nizes that the common law now holds that if the fetus survives it may recover for injuries sustained in the womb. the common law now also permits a death ac­ tion if the infant survives birth and then dies from inju­ ries sustained in the womb. the majority finds no logic in the premise that if the viable infant dies immediately before birth it is not a "person" but that if it dies imme­ diately after birth it is a "person." we take note, further, that the magic moment of"birth" is no longer determined by nature. the advances of sci­ ence have given the doctor, armed with drugs and scal­ pel, the power to determine just when "birth" shall occur. we believe that the common law now recognizes that it is the ability of the fetus to sustain life independ­ ently of the mother's body that should determine when tort law should recognize it as a "person" whose loss is compensable to the survivors. we acknowledge, of course, that this, too, is an artificial line, difficult at times to determine. it is not possible to draw any line without being arbitrary to some extent. nevertheless, we believe that with regard to the issue of recognizing a loss to the survivors, viability is a less arbitrary and more log­ ical point than the moment ofbirth. the moment of vi­ ability may be difficult to prove in those few cases where that moment and the tortious injury are temporally close. we do not believe, however, that a just remedy should be denied in all cases simply because proof may be difficult in a few.34 iv. the jeter case a. facts and holding [vol. 5:251 belinda and william jeter went to the mayo clinic arizona to obtain in­ formation to help them conceive a child. after consultation, the couple decided maintain action or to recover damages for death of unborn child, 84 a.l.r. 3d 411 ( 1978). 34. summerfield, 698 p .2d at 722. 2008] 0econstructing jeter v. mayo clinic arizona 259 to attempt in vitro fertilization. shortly thereafter, dr. anita singh retrieved eggs from mrs. jeter at the mayo clinic after which the eggs were fertilized with mr. jeter's sperm. the resulting zygotes grew and developed for two to three days until they became identifiable as eight-cell organisms which the court referred to as pre-embryos. two attempts to impregnate mrs. jeter failed, and the remaining pre-embryos were frozen. unwilling to give up, the jeters decided to try in vitro fertilization again, but with a different clinic, the arizona center for fertility studies to which the jeters arranged for transfer of there­ maining pre-embryos.35 according to the jeters, ten pre-embryos should have been transferred by the mayo clinic, but two of the four cryotubes used for transportation were empty, and only five pre-embryos arrived at the arizona center. 36 mrs. jeter underwent a tubal embryo transfer at the arizona center, became pregnant, and delivered a daughter. still, the jeters wanted to have more children with the help of the arizona center for fertility studies, but no pre-embryos remained. with the loss of the pre-embryos, the jeters were concerned about the addi­ tional discomfort and cost that would be required to replace them. the jeters sued the mayo clinic arizona alleging wrongful death of the five lost pre­ embryos, negligence, breach of fiduciary duty, and breach of a bailment con­ tract. on motion for summary judgment, the trial court dismissed all four claims. but on appeal the latter three claims were reinstated, and only the wrongful death claim was dismissed. 37 dismissal of the wrongful death claim was essentially a two-part process for the court. the jeter court first decided that arizona law did not recognize the pre-embryos as persons pursuant to the wrongful death statute as interpreted in summerfield because the pre-embryos were not ''viable.'.38 second, the court undertook an evaluation of the status of pre-embryos to decide whether the de­ finition of "person" under the statute should be expanded to include pre­ embryos. 39 the court decided the statute should not be expanded by judicial action but indicated the legislature might be able to take such action. 40 wheth35. the author is a colleague of the ivf laboratory technician for the arizona center for fertility studies, a recently retired arizona state university biology professor, dr. robert mcgaughey. because the case is pending trial, and he is both a fact and expert witness for the jeters, dr. mcgaughey respectfully declined to discuss the case with the author. however, the jeters' attorney graciously made dr. mcgaughey's deposition available. 36. the mayo clinic contends it transferred all ten pre-embryos and five embryos must have been lost due to the arizona center for fertility studies' failure to follow mayo clinic's thawing protocol. 37. jeterv. mayo clinic arizona, 121 p.3d 1256, 1260 (ariz. ct. app. 2005). 38. !d. at 1261. 39. !d. at 1262. 40. jd. at 1259 ("[w]e affirm the superior court's dismissal of the wrongful death claim and hold that absent legislative action expanding the wrongful death statutes, as a matter oflaw, a cryopreserved, three-day old fertilized human egg is not a "person" for purposes of that stat­ ute."). 260 indiana health law review [vol. 5:251 er the second part of the analysis was actually necessary was a matter debated by the three-judge panel and caused a specially concurring opinion to be filed. the majority aptly applies the summerfield model of analysis to conclude that "a fertilized human egg outside the womb is not a 'person' within the meaning of a.r.s. § 12-611 regardless of whether that fertilized egg consti­ tutes human life or potential human life." i agree with this reasoning and, for that reason alone, i concur with the majority's resolution of the first issue on appeal. however, in my view, resolution of the issue ends after application of summerfield. consequently, i believe the majority's discussion of the debate concerning when life begins is unnecessary, and i therefore do not join in this portion of the decision.41 b. pre-embryos were not viable the jeter court explained that the arizona wrongful death statute does not define "person.',..2 in summerfield, the arizona supreme court stated the word "person" included a viable fetus.43 in 2000, the arizona legislature superfi­ cially amended a portion of the wrongful death statute without comment, so it can be assumed the legislature both knew and approved of the summerfield definition of"person.'m therefore, the jeters can only make a claim for wrong­ ful death if their pre-embryos were "viable.'' in their briefto the court, the jeters called the pre-embryos "viable frozen embryos" as a statement offact.45 in his deposition, dr. robert mcgaughey of the arizona center for fertility studies described the pre-embryos as "viable" several times, by which he seemed to mean there was no discemable reason why the pre-embryos could not be used successfully to impregnate mrs. jeter.46 the jeter court rejected this terminology, saying it was not a factual claim stating "while the jeters' complaint refers to these fertilized eggs as 'viable em­ bryos,' such a characterization is a conclusion that is not necessarily implied from the well-pleaded facts. ,,..7 a fair question would be whether viability can 41. id. at 1276 (timmer, j., specially concurring). 42. id. at 1263. 43. summerfield v. super. ct., 698 p.2d 712,722 (ariz. 1985). 44. jeter, 121 p.3d at 1263. 45. jeter, 121 p.3d at 1259. 46. dr. mcgaughey's deposition was not taken until december 2006, long after the court of appeals ruling. the jeter court was not presented with any expert testimony by any of the medical doctors or scientists involved on the issue of viability. 47. jeter, 121 p.3dat 1259. because the case was beforethecourtonappeal from sum­ mary judgment, the court was required to accept the facts in a light most favorable to the jeters. 2008] deconstructing jeter v. mayo clinic arizona 261 ever be proved by factual assertions. to answer this question one must first understand what viability means under the law. the use of fetal viability in american law traces its lineage back to a dis­ sent by justice carroll c. boggs in the 1900 illinois supreme court case of al­ laire v. st. luke's hospita/.48 thomas allaire, an infant, sued for injuries he suffered while his mother was riding an elevator in the defendant's hospital while on her way to the obstetrics ward for delivery. because thomas was still in the womb at the time of the alleged negligence, the court dismissed his claim, stating that the infant plaintiff did not have a distinct and independent existence but was a part of his mother and that the injury was to her, not the infant. in a dissent that became influential a half-century later, justice boggs wrote, a foetus in the womb of the mother may well be re­ garded as but a part of the bowels of the mother during a portion of the period of gestation; but if, while in the womb, it reaches that prenatal age of viability when the destruction of the life of the mother does not necessarily end its existence also, and when, if separated premature­ ly, and by artificial means, from the mother, it would be so far a matured human being as that it would live and grow, mentally and physically, as other children general­ ly, it is but to deny a palpable fact to argue there is but one life, and that the life of the mother. medical science and skill and experience have demonstrated that at a pe­ riod of gestation in advance of the period of parturition the foetus is capable of independent and separate life, and that, though within the body of the mother, it is not merely a part of her body, for her body may die in all of its parts and the child remain alive, and capable of main­ taining life, when separated from the dead body of the mother. if at that period a child so advanced is injured in its limbs or members, and is born into the living world suffering from the effects of the injury, is it not sacrifice­ ing truth to a mere theoretical abstraction to say the in­ jury was not to the child, but wholly to the mother?49 in a later case inl933, the supreme court of canada allowed a claim for injuries suffered by a viable fetus, reasoning that because criminal law punished the particular conduct in question, civil law should likewise recognize the same had the case been on appeal from a trial verdict, the court would accept the findings of the trier of fact, usually a jury. the court remains free to apply the law as it sees fit to the facts pre­ sented. 48. allaire v. st. luke's hospital, 56 n.e. 638 (ill. 1900). 49. /d. at 641 (boggs, j., dissenting). 262 indiana health law review [vol. 5:251 conduct as constituting a tort. 50 but it was not until after world war ii that an american court recognized a cause of action for injury or death to a viable fe­ tus, which occurred in the district of columbia decision of bonbrest v. kotz, in 1946.51 here, however, we have a viable child--one capable of living outside the womb--and which has demonstrated its capacity to survive by surviving-are we to say now it has no locus standi in court or elsewhere? as to a viable child being 'part' of its mother-this ar­ gument seems to me to be a contradiction in terms. true, it is in the womb, but it is capable now of extra­ uterine life-and while dependent for its continued de­ velopment on sustenance derived from its peculiar rela­ tionship to its mother, it is not a 'part' of the mother in the sense of a constituent element-as that term is gen­ erally understood. modem medicine is replete with cas­ es of living children being taken from dead mothers. indeed, apart from viability, a non-viable foetus is not a part of its mother. 52 judging from this language, the bonbrest court may very well have ex­ tended the right to compensation even to non-viable fetuses, had the facts of the case warranted it. still, the court continued to insist that the child be born alive before an action could be brought, even if the injury occurred while in the womb. from these early cases, it is clear that viability meant actual survival when something happened to endanger the health of the mother, and actual sur­ vival was evidence of a separate existence apart from the mother. the bonbrest court seemed to point out that it was a separate existence that defined a person, but it was actual survival that gave evidence of that separate existence. by the time of roe v. wade53 in 1973, the concept of viability had pro­ gressed from actual survival into the potential to survive. the roe court did 50. montreal tramways v. leveille, [1933] s.c.r. 456 (can.). the criminal1aw in ques­ tion was the infant life preservation act, 19 & 20 geo. v. (1929) (eng.). see generally p.h. winfield, the unborn child, u. torontol.j. 278,278 (1942). 51. bonbrest v. kotz, 65 f .supp. 138 (d.d.c. 1946)( citing favorably the reasoning from montreal tramways v. leveille). 52. bonbrest, 65 f. supp. at 140, n.11 (citing george w. corner, ourselves unborn: an embryologist's essay on man, 1, 69 (yale university press)(1944)("bythe eighth week the embryo or foetus, as we now call it, is an unmistakable human being, even though it is still only three-quarters of an inch long .... indeed, the chinese have long recognized that when a man is born he is already nine months old. each of their babies is given at birth a full year's credit on the reckoning of its age."); (also citing esther m. greisheimer, physiology and anatomy 738 (j. b. lippincott & co.,) (5th ed. 1945)). 53. roe v. wade, 410 u.s. 113 (1973). 2008] deconstructing jeter v. mayo clinic arizona 263 not initiate this change, but the magnitude of its decision validated the point. after roe, whether or not the embryo or fetus actually survived became much less important. physicians and their scientific colleagues have ... tended to focus either upon conception, upon live birth, or upon the interim point at which the fetus becomes 'viable,' that is, potentially able to live outside the mother's womb, albeit with artificial aid. viability is usually placed at about seven months (28 weeks) but may occur earlier, even at 24 weeks. 54 •••• [t]he state does have an important and legitimate inter­ est in preserving and protecting the health of the preg­ nant woman ... and ... it has still another important and legitimate interest in protecting the potentiality ofhuman life. these interests are separate and distinct. each grows in substantiality as the woman approaches term and, at a point during pregnancy, each becomes 'com­ pelling.' .... with respect to the state's important and legitimate in­ terest in potential life, the 'compelling' point is at viabil­ ity. this is so because the fetus then presumably has the capability of meaningful life outside the mother's womb.55 furthermore, the roe court clearly ruled that the state had a legitimate in­ terest in embryonic and fetal life from the earliest stages of development. 56 vi­ ability only had significance insofar as it created a tipping point in favor of the state's interests over the pregnant woman's rights pursuant to the court's con­ stitutional substantive due process formulation. that is, the state's interest must be "compelling. "57 state courts, however, were slow to recognize the sig­ nificance of the roe decision in fields oflaw other than abortion. some courts focused on the woman's right to an abortion and mistakenly granted those same rights to third parties.58 however, in the decades since 1973, a clear trend 54. /d. at 160. 55. /d. at 160-63. 56. /d. at 158. 57. /d. at 163. 58. see, e.g., toth v. goree, 237 n.w.2d 297 (mich. ct. app. 1975) ("roe v. wade ... has had a considerable impact on the legal status of the fetus .... if the mother can intentionally terminate the pregnancy at three months, without regard to the rights of the fetus, it becomes increasingly difficult to justify holding a third person liable to the fetus for unknowingly and unintentionally, but negligently, causing the pregnancy to end at that same stage. there would 264 indiana health law review [vol. 5:251 emerged that expanded legal protections for embryos and fetuses to develop­ mental stages earlier than viability. the minority position among jurisdictions in 1973, soon became the ma­ jority position in large part because of roe. the new majority position said it was not necessary for the infant to be born alive in order to recover damages, but only that an infant must be physically capable of surviving had it been born at the time of the injury. the move from the minority position to the majority position was an attempt by courts to eradicate a gap in the law whereby a wrongdoer who caused a fetus to die in the womb was punished less than one who merely caused injury to the fetus that could still be born alive. within a decade after roe, the majority position was that it was not necessary for a viable fetus to be born alive in order for a cause of action to exist for its death or in­ jury.59 although this remains the current consensus, it seems an exceedingly odd legal fiction.60 in cases that arose under this viability legal fiction, no infant was born alive, so survivability was no longer relevant. it is just as accurate to claim that, but for an injury, a seven-week-old embryo would have been born alive, as it is to make the claim for a seven-month-old "viable" fetus.61 this logical conclusion is what led courts to reject viability as a standard for when a non-fatal injury was tortious-an infant that was injured prior to viability was just as damaged as one injured post viability. after roe, viability became a legal fiction that represented two rationales. first, viability represented a way to biologically justify a social balancing act between fetal life and women's rights. second, it was also a vestige of old ideas about fetal survivability that was rendered obsolete by abolition of the "born alive" rule that remained settled precedent. increasingly, courts and legislatures are distinguishing the former rationale as only applicable to abortion and abandoning the latter.62 be an inherent conflict in giving the mother the right to terminate the pregnancy yet holding that an action may be brought on behalf of the same fetus under the wrongful death act."). 59. summerfield v. super. ct., 698 p.2d 712, 722-3 (ariz. 1985) ("at present, thirty-two jurisdictions recognize a cause of action for wrongful death when a viable fetus is stillborn as a result of tortious negligence. only ten jurisdictions (including arizona, per kilmer v. hicks, supra) do not recognize such a cause of action unless live birth takes place. thus, the statement in kilmer v. hicks, supra, that only a minority of courts allow the action, no longer holds true."). 60. this is not a new characterization of the problem with viability as a demarcation. see, e.g., university of pennsylvania, the impact of medical knowledge on the law relating to prenatallnjuries, 110 u. pa. l. rev. 554,554 (1962). in the 1950s, viability was the dividing line in most jurisdictions for tort actions filed after live birth, that is, an infant could only sue for prenatal injuries if they happened after viability. that rule was criticized and eventually abol­ ished in all u.s. jurisdictions. 61. although proof may be more difficult. 62. see, e.g., minnesota v. merrill, 450 n.w.2d 318, 322 (minn. 1990) ("the state's in­ terest in protecting the "potentiality of human life" includes protection of the unborn child, whether an embryo or a nonviable or viable fetus. in this context, the viability of the fetus is "simply immaterial" to an equal protection challenge to the feticide statute."); wiersma v. maple leaf farms, 543 n.w.2d 787, 792 (s.d. 1996) ("[t]he concept of viability is outmoded in tort law. "viability'' as a developmental turning point was embraced in abortion cases to balance the privacy rights of a mother as against her unborn child. for any other purpose, viability is purely an arbitrary milestone from which to reckon a child's legal existence."); farley v. sartin, 466 2008] deconstrvctingjeter v. mayo clinic arizona 265 but, the issue in jeter was whether in vitro pre-embryos were viable. the court therefore argued that the jeters' situation was different from embryos in the womb, even though the pre-embryos were apparently surviving independ­ ently of mrs. jeter's body, albeit in a cryopreserved condition, before they dis­ appeared. given the confused state of what viability means, it is perhaps not surprising the jeter court searched for words to explain the situation. it is important to understand what the jeters argue. nei­ ther in the superior court nor in this court did the jeters claim that they had evidence to support a view that a cryopreserved pre-embryo fits within the definition of a viable fetus as discussed in summerfield, that is, an en­ tity which can presently survive to birth outside of the womb. rather, relying on various treatises, the jeters contend that medical science has so advanced since the supreme court decided summeifield, that as a matter of law and statutory construction, this court should expand the definition of a 'person' articulated in summeifield to allow wrongful death actions for the loss of cryopre­ served three-day-old eight-celled pre-embryos because they have the potential to become viable. they contend those medical advances allow such pre-embryos to main­ tain extrauterine life via the cryopreservation process. 63 in other words, the jeters argued their pre-embryos were viable because they were already living outside the womb. judge kessler called this definition "potential viability" and rejected it in favor of"present viability" because the pre-embryos would still have to go into the womb to develop.64 it is this dis­ tinction that prompted the curious language "survive to birth outside the womb." this language is curious because something that is already outside the womb cannot be "born" in any common sense of the word. the language is tortured because the viability standard cannot easily be applied to this circum­ stance. this is evident as the jeter court also used the concept of uncertain sur­ vivability to bolster its finding that the pre-embryos were not viable. unlike a viable fetus, many variables affect whether a fertilized egg outside the womb will eventually result in the birth of a child. this makes it speculative at best to s.e.2d 522, 533 (w.va. 1995) ("after reviewing a number ofnonviableunbom child decisions in jurisdictions that permit a cause of action for a viable unborn child, we can find no legitimate or persuasive reason to infuse the distinction into west virginia's statute. we do not believe that proper application of stare decisis prevents us from rejecting an unjustified and unpersua­ sive majority position."). 63. jeter v. mayo clinic arizona, 121 p.3d 1256, 1259 (ariz. ct. app. 2005). 64. id. 266 indiana health law review conclude that but for the injury to the fertilized egg a child would have been born and therefore entitled to b . . "' h . . 65 nng smt 10r t e injury. . ... for cryopreserved pre-embryos, only 65% survived thawing and only 20.3% led to live births. moreover, in 2001, 72% of all assisted reproductive technology trans­ fers failed to lead to a birth.66 .••• the ninth circuit adopted the viability concept endorsed by our supreme court in summerfield, recognizing that, with regard to wrongful death actions, numerous courts had used "viability as the dividing line for 'personhood' because it denotes the point at which the fetus, in es­ sence, becomes a person, or a 'separate entity capable of maintaining an independent action in its own right."' the court found this test was particularly appropriate given that "the uncertainty of whether a pregnancy will culminate in a live birth is greatest at the beginning of a pregnancy. thus, [courts] refuse to allow recovery be­ cause of the uncertainty and unpredictability of actions based on speculation that the fetus would have otherwise survived to viability." this reasoning is even more compelling here because the pre-embryos were cryopre­ served for possible future use and might never have been implanted in the womb, much less survive to a live birth.67 [vol. 5:251 if the likelihood of a child making it to birth is very low, such as the one in five chance given by the president's council on bioethics to frozen pre­ embryos, then a sound argument can be made that the pre-embryo is not a per­ son, if you assume that survivability to birth is an important criterion. how­ ever, the modern viability standard presumes that surviving to birth is not important, but that the potential to survive is. each of the five pre-embryos had the potential to survive.68 and, in any case, the likelihood that one of the five 65. !d. at 1262 (citing robertson v. sixpence inns of am., inc., 789 p.2d 1040, 1047 (ariz. 1990)). 66. !d. at 1266 (citing the president's council on bioethics, u.s. public policy and the biotechnologies that touch the beginnings of human life: a detailed overview (2003), available at http://www.bioethics.gov/backgroundlbiotechnology.html (last visited apr. 29, 2008)). 67. !d. at 1270 (citing santana v. zilog, inc., 95 f.3d 780, 783-84 (9th cir. 1996). 68. this potential to survive is what the author believes dr. mcgaughey was talking about when he described the in vitro pre-embryos as "viable" several times in his deposition. this is also the usage preferred by the jeters in their factual argument to the court that was rejected. 2008] deconstructing jeter v. mayo clinic arizona 267 pre-embryos would survive to birth was much higher than twenty percent, so a counter argument could be made that a group of five pre-embryos likely con­ tains at least one that will survive to birth and thus should be considered a per­ son, under this criteria.69 the court's comment that the pre-embryos "might never have been implanted in the womb" seems irrelevant for the case it was deciding because the jeters intended to have them implanted. the jeter court went on to define viability in concrete terms as though vi­ ability was a phase of biological development. "[v]iability means that, once implanted in the womb, the embryo has reached a stage of development that, if it is taken out of the womb, it would be viable."70 even disregarding the circu­ lar definition, this statement misstates what viability actually means in this con­ text. applying arizona's wrongful death law as interpreted in summerfield and jeter, viability means after implantation in the womb, the typical embryo/fetus would have developed long enough that it probably would live for a reasonable period of time outside the womb under medical supervision, assuming we dis­ regard the injury which caused death in this case. the jeter court added the after implantation in the womb part to the summerfield definition in order to find that in vitro embryos were not viable. without that proviso, a solid argu­ ment could be made that in vitro embryos satisfy the criteria of viability. this is not to suggest that the jeter court was wrong for doing so. the arizona leg­ islature had just modified the manslaughter statute to exclude in vitro embryos from its purview. it is fair to ask why the courts are still making modifications to the viabil­ ity standard when it is such a poor method for evaluating legal protections for early-stage human life. the jeter court accurately stated "the jeters do not contend that three-day-old, eight-celled cryopreserved pre-embryos can exist and develop into viable entities exutero."71 this language also is bizarre un­ less we assume a "viable entity" is some defined stage of development. one would think that an embryo capable of developing entirely ex-utero would be considered viable. ethical and legal issues concerning the development of an artificial womb are now being seriously discussed. two authors have suggested the creation of a legal fiction called "viability" equivalent to personhood (an­ other legal fiction) that would occur at a defined stage of biological develop­ ment when people can visually recognize the embryo or fetus gestating in an artificial womb to be human, which would presumably represent the point at which a human life begins.72 such a stage of development has not yet been 69. statistically, if there was an eighty percent chance each of the pre-embryos was a "dud" that would not survive to birth, then the chance all five were duds was about one in three. to phrase another way, there was a sixty-seven percent chance at least one of the pre-embryos would survive to birth after transfer to mrs. jeter's fallopian tube. 70. jeter, 121 p.3d at 1265 (citing thibert v. milka, 646 n.e.2d 1025 (mass. 1995). 71. /d. at 1265. 72. joyce m. raskin & nadav mazor, the artificial womb and human subject research, in ectoge'nesis: artificial womb technology and the future of human reproduction 159 (scott gelfand & john r. shook, eds., rodopi bv 2006). 268 indiana health law review [vol. 5:251 defined, although many courts seem to believe there is one. an argument could be made that artificial wombs already exist in neonatal wards and are used to sustain the lives of premature infants. such technology has uniformly been considered to extend the period of viability to earlier stages of pregnancy. as technology in neonatal care units improves, institutions move their "viability" estimates to earlier in gestation. 73 advances in technology affect the scientific proof of viability as well. c. evidentiary issues whether or not a fetus was viable at the time of death or injury has gener­ ally been considered a question of fact for a jury to decide based on medical testimony.74 this principle was described by an illinois court in 1978. relying principally on "obstetrics" by professor nichol­ son j. eastman, professor of obstetrics at johns-hopkins university, defendants argue that the smallest, youngest fetus ever to have survived was 20 weeks and weighed approximately 400 grams; that the fetus in this case at 14 weeks would probably weigh less than 120 grams and as a matter oflaw, was not viable. we note that the edition (1oth) of "obstetrics" upon which defendants rely was published in 1950, and we have not been favored with information concerning the opinions expressed in the four editions published since that time. from our review of the authorities we are unable to say that as a matter of law the unborn infant was not viable at the time of the occurrence which allegedly caused its "death." it does not appear that in the present state of medical science it can be held that beyond question the fetus here involved could not have survived separate from and independent of its mother. under the circum­ stances we hold that the question whether the unborn in­ fant was viable at the time of the occurrence was one of fact and the appellate and circuit courts erred in deciding the question as one oflaw.75 73. see, e.g., new scientist.com, world's most premature baby set to leave hospital, new scientist, feb. 20, 2007, http://www.newscientist.com/article/dn11222-worlds-most­ premature-baby-set-to-leave-hospital.html (last visited apr. 29, 2008). 74. green v. smith, 377n.e.2d37 (ill. 1978); see also fed. credit union v. tucker, 853 so. 2d 104 (miss. 2003) (indicating whether child was "quick" was a fact issue for the jury). 75. green v. smith, 377 n.e.2d 37, 39 (ill. 1978). 2008] deconstructing jeter v. mayo clinic arizona 269 the jeter court, however, ruled that the pre-embryos were not persons under the wrongful death statute as a matter of law because they were not vi­ able. that is, no medical or scientific testimony would have swayed the court on this issue because the pre-embryos were not implanted in the womb. the court decided that implantation was a prerequisite for viability (which was re­ quired to be a person under the statute). in any case, neither party presented any evidence to the court regarding the viability ofthe pre-embryos. both par­ ties characterized in their briefs, the opinions and assertions made in a few ex­ tra-judicialleamed treatises, mostly law journal articles.76 additionally, the jeter court itself undertook an extra-judicial investigation into the various legal, philosophical, biological, and religious ideas about the beginning oflife. none of this material was subject to any evidentiary standards. we summarize our understanding of the current state of knowledge of embryonic development not to dictate or prejudge any decision as to when life should be consid­ ered to begin for purposes of a wrongful death action. rather, we do so to fairly respond to the jeters' claim that, as a matter of law, a court should re-interpret the wrongful death statutes to define "person" to include a cryopreserved three-day old, eight-celled fertilized egg. the following summary is taken from a number of sources, including maienschein at 256-62; ronald m. green, the human embryo research debates-bioethics in the vortex of controversy at 6-8, 27-29, 42 (2001) ("green"); andrea l. bonnicksen, crafting a cloning policy-from dolly to stem cells at 20-25 & 69-71 (2002) ("bonnicksen"); james a. thomson, human embryonic stem cells, in the human embryonic stem cell debate (suzanne holland, karen lebacqz, laurie zoloth, eds.) (2001) ("holland") at 15; thomas a. shannon, from the micro to the macro, in holland at 178; kiessling at 1 055-65."77 the court's denial that it was prejudging any decision as to when life should be considered to begin is interesting because it repeatedly invited the legislature to make such a decision. nevertheless, the court's purpose in con­ ducting this literature review was to express the reason for its refusal to expand 76. jeter, 121 p.3d at 1267. 77. !d. at 1266. it is worth noting the disciplinary expertise of each ofthe authors cited by the court in support of its statements about developmental biology: maienschein (history and philosophy ofbiology); green (religion); bonnicksen (political science); thomson (cell biol­ ogy); shannon (religion and social ethics); kiessling (biochemistry). 270 indiana health law review [vol. 5:251 the meaning of"person" beyond viability to include pre-embryos. that is, after concluding that the existing standard for personhood was viability, and that the pre-embryos did not meet that standard as a matter of law, the court addressed whether or not it should go ahead and change the standard to include pre­ embryos as persons in the absence of viability. the reason the court refused to expand the definition of"person" was essentially that there was no consensus among authors of learned treatises on the answer to the question of when hu­ man life begins. 78 but most authors agreed that a pre-embryo does not qualify as a human life. while the jeters rely on several medical-legal texts to support their argument that human life begins at concep­ tion, those texts are only part of the discussion among scientists, philosophers, ethicists and the public as a whole on the issue of when society should consider life to begin. most of these authors do not support the idea of expanding the concept to cryopreserved pre-embryos. 79 given this lack of support for the jeters' position, the court decided to let stand the summerfield decision that a fetus must be viable to be a person for wrongful death purposes, in spite of the fact that the viability standard was un­ deniably a minority position in the literature as well. when one considers all the literature promoting opinions about when a human life begins whether it be based upon biology, philosophy, religion, or any other thinking disciplines, one is still left to wonder how the viability standard manages to endure in the face of so much dissent. 80 the lack of consensus naturally calls for an answer to the question, who gets to decide what the standard is? if the arizona legislature defined "person" as the "product of conception at any stage of development,"81 as it was defined in the pre-2005 manslaughter statute, would the courts then accede to this definition despite the lack of support from learned authorities? from the court's many invitations to the legislature, it seems it would. as explained by both forsythe at 504-10 and green at 22-25 and 63-66, there are various theories of what con­ stitutes a "person." one current analysis is to examine various subjective attributes including the capacity to feel pain, experience pleasure, survive and react to the en­ vironment. in contrast, various authors taking a deve78. jd. at 1268. 79. jd. at 1267. 80. viability gains most, if not all of its persuasive force from abortion precedent. see roe v. wade, 410 u.s. 113 (1973). 81. ariz. rev. stat. ann. § 13-1103 (2007). 2008] deconstructing jeter v. mayo clinic arizona lopmental perspective consider implantation, develop­ ment of the embryonic disc at fourteen days of fertiliza­ tion, sentience, viability and/or the existence of brain waves. the 1994 national institutes ofhealth human embryo research panel took a pluralistic approach, ex­ amining the increasing possession of qualities that make respecting the entity more compelling. an opposing view contends a human being is created at the time of fertilization because at that time the embryo has an ac­ tive capacity to eventually articulate itself into a human being. forsythe at 474-78. the lack of any clear, gen­ erally accepted concept of when "personhood" occurs further supports leaving the decision as to further ex­ panding the term "person" for wrongful death purposes to the legislature. 82 271 in its opinion, the court in jeter stated twenty-one times that it should be for the legislature, not the courts, to decide whether or not to change the defini­ tion of"person" in the wrongful death statute. does this mean the courts would completely abdicate the authority to decide when human life begins, even so far as to allow the legislature to count in vitro embryos as persons? we will soon have one answer to that question when the illinois courts reach a final decision in the miller case. 83 given the statutory scheme in louisiana, a similar issue could arise there. 84 the court in jeter was clear in its belief that the legislature is better situated to decide such issues. indeed, there are important societal interests which help fuel the current discussion concerning when life should be considered to begin. on the one side is the conten­ tion that there are benefits of utilizing human pre­ embryonic material for stem cell research to diagnose and treat severe medical conditions, including infertility. this interest, however, is balanced against respect for human life ... it is the balancing of these two primary concerns that underscores the need for reasoned legislative, not judi82. jeter, 121 p.3d at 1267-68. 83. miller v. american infertility group, no. 02-l-7394 (cir. ct. cook county, ill. feb. 4, 2005). see also la. rev. stat. ann.§ 9:123 (2006) ("an in vitro fertilized human ovum exists as a juridical person until such time as the in vitro fertilized ovum is implanted in the womb; or at any other time when rights attach to an unborn child in accordance with law."). 272 indiana health law review cial, decision-making as to the nature of a "person" un­ der the wrongful death statutes ... 85 [vol. 5:251 leaving the decision to the legislature is a solid democratic position. but, is this a question that should be answered through the political process, or is it a question that should be answered, at least in part by science? after all, we are not talking about, for example, whether children should be able to obtain social security survivor benefits if their father died while they were frozen em­ bryos before they were implanted in the womb using nf. 86 we are talking about whether the embryo is a human being whose life is worthy ofbeing pro­ tected by law. is this a question we as a society wish to leave to the vagaries of political decision-making, beholden as it is to compromise, economics, interest­ group pressure, and the basest forms of populism? should the definition of "person" in the wrongful death statute be affected by the group that raises more money between the stem-cell lobby and the right-to-life lobby? because the courts are bound by definitions promulgated in statutes that are sources ofliti­ gation, courts remain unwilling to take a stand on when human life begins.87 d. science and law the jeter court devoted three of its ninety-four paragraphs to a general overview of the developmental biology of the human embryo from fertilization to eight weeks gestation and did not discuss the biology of the fetus. 88 neither party submitted any expert scientific testimony to the trial court or the court of appeals regarding when a human life begins. in the parties' briefs, the only sources cited that could be considered scientific was one citation to support statements about the number of frozen embryos in the united states, 89 and two definitions from a medical dictionary. 90 the court also cited a couple scientific sources independently.91 85. jeter, 121 p.3d 1268-9. 86. see woodward v. comm'r of social sec., 760 n.e.2d 257 (mass. 2002); gillett­ netting v. barnhart, 371 f.3d 593 (9th cir. 2004). 87. only one case stands apart as an instance in which a court rejected a legislature's defi­ nitionoflife in favorofitsown. jnevans v.people,49n.y. 86 (n.y. 1872), the highest new york state court rejected the legislature's penalties for causing the death of an unborn child prior to "quickening" on the grounds that an unborn child did not become alive until it was "quick," so no death could possibly occur. however, the new york legislature had enacted several statutes over the preceding years with contradictory provisions and gaping legal loop­ holes. the court was merely affirming the common law rule. see also means, c., the law of new york concerning abortion and the status of the foetus 1664-1968: a case of cessation of constitutionality, 14 nylf 411 (1%8). 88. jeter v. mayo clinic arizona, 121 p.3d 1256, 1266-1268 (ariz. ct. app. 2005). 89. jeter, 121 p.3d at 1256 (citing brieffor petitioner appellant at 20, jeter v. mayo clinic arizona, 121 p.3d 1256 (ariz. ct. app. 2005) (no. 1 ca-cv 04-0048) citing to david ho:ffinan et al., cryopreserved embryos in the united states and their availability for re­ search, 19 fertility and steriijty 1063, 1063 (2003)). 90. jeter, 121 p.3d 1256(citingbriefforappelleeat8, 17,jeterv.mayo0inicarizona, 2008] deconstructing jeter v. mayo clinic arizona 273 all parties and the court treated the question of when life begins as a question of law only marginally affected by "constitutional" or "legislative" facts.92 from a financial perspective, this makes some sense. the jeters, in particular, were probably not well situated to pay for the expert witness fees necessary to produce a record of sufficient weight to the point where it might alter the court's opinion that personhood was a question oflaw and not offact. however, the court could have undertaken a more in-depth factual analysis of embryonic development had it been interested in deciding when a human life begins. understanding the relevant science is becoming a new requirement for proper adjudication, as illustrated by justice breyer in the context of assisted suicide. is that right to assisted suicide part of the liberty that the constitution protects? underlying the legal question was a medical question: to what extent can medical technology reduce or eliminate the risk of dying in se­ vere pain? the medical question did not determine the answer to the legal question, but, i believe, that to do our legal job properly we needed to develop an informed, though necessarily approximate, understanding of the state of that relevant scientific art. 93 while the jeter court stated something similar in its opinion, 94 the thrust of the decision was exactly opposite from the sentiment of justice breyer's suggestion. the jeter court did not use the scientific evidence it reviewed to guide its decision about when life begins. the jeter court altogether rejected the idea of using scientific evidence to guide its decision.95 the jeter court specifically stated that the multiplicity of opinion among scholars and the pub­ lic as to when a human life begins was a valid reason to avoid deciding the is­ sue.96 the u.s. supreme court made the same claim in the roe case-that it was not deciding the issue of when a human life begins.97 nevertheless, courts 121 p.3d 1256 (ariz. ct. app. 2005) (no. i ca-cv 04-0048) citing to the american heritage stedman's medical dictionary (editors of the american heritage dictionaries eds., 1995)). 91. jeter, 121 p.3d at 1266. 92. for a discussion of constitutional facts, see david l. faigman, a unified theory of constitutional facts, http:/llaw.bepress.com/expresso/eps/1149/ (last visited apr. 29, 2008). 93. breyer, supra note 2, at 24-5. 94. jeter, 121 p .3d at 1258 ("analytically, it is not the name but the biological details of development that should help guide the discussion of when to consider that life begins."). 95. jeter, 121 p.3d at 1268. 96. id. 97. roe v. wade, 410 u.s. 113, 159 (1973) (stating "we need not resolve the difficult question of when life begins. when those trained in the respective disciplines of medicine, phi­ losophy, and theology are unable to arrive at any consensus, the judiciary, at this point in the development of man's knowledge, is not in a position to speculate as to the answer."). 274 indiana health law review [vol. 5:251 have persisted in finding that personhood begins at viability, just as the jeter court did. · certainly, "person" and "human being" could be different, and often are. nevertheless, human developmental biology is a relevant factor in deciding the personhood of the human embryo or fetus. in new jersey, a case is currently pending where a jury might be asked to decide if medical malpractice has been committed by an abortion doctor's failure to inform his patient that her six-to­ seven week old embryo was a complete, unique, living human being. 98 in order for a jury to make such a decision, the parties will have to submit extensive ex­ pert biological testimony. juries only decide fact questions, so they will need to know all the facts about embryonic development. the same kind of circum­ stance could arise in a case involving cryogenically preserved pre-embryos. would the court in such a case rule that whether the pre-embryo is a complete, unique, living human being is a question offact for a jury to decide? this rais­ es the prospect of contradictory resolution of identical fact patterns, as often can happen with jury decisions in multiple cases because they are independent of one another. jury selection in such a case would be a harrowing experience. because there seem to be so many conflicting opinions about life based on phi­ losophy, religion, personal experiences, and plain old politics, it might be diffi­ cult for a jury to come to a decision. of course, the same could be said of many issues that juries routinely decide. if a jury must decide the fact question of whether an embryo is a com­ plete, unique, living human being in a lack-of-informed-consent malpractice case, then why would a wrongful death case such as jeter be different? the issue certainly seems to be the same. if the embryo is a living human being, then the legislature's statutory intent to create a cause of action for compensa­ tion to survivors of a "person" wrongfully killed would be frustrated by a ruling that the embryo is not a person as a matter of law. the trier of fact, most likely a jury, would have to decide if the embryo is a person. v. conclusion the jeter decision presents some interesting questions about how our le­ gal system decides issues of embryo and fetal personhood. the viability stan­ dard has been ensconced in the judicial system for many years and remains a strong precedent for deciding when a human life begins because of the roe de­ cision and the continuing abortion debate. however, the viability standard has lost almost all its support and intellectual force outside the context of abortion. legislatures now routinely promulgate criminal and civil statutes that afford protection to the embryo at a very early stage of development. courts have not interfered with these legislative standards, but courts have conservatively relied on the old viability standard in the absence of legislative action. 98. acuna, 894 a.2d at 1212. 2008] deconstrvctingjeter v. mayo clinic arizona 275 the determination of when a human life begins has been viewed as both a question of law for the judge to decide and a question of fact for a jury to de­ cide. the jeter court viewed the question as one oflaw, and refused to expand the meaning of "person" in arizona's wrongful death statute to include pre­ embryos because there was not much support for such a view in the literature the court consulted. however, because the question was one oflaw, the court did not have expert testimony or extensive evidence about developmental biol­ ogy. a jury, on the other hand, would have access to this evidence in resolving a question of fact. cases may soon go to a jury to decide when a human life begins in new jersey and south dakota, ifthe courts in those states allow it to happen. the time appears to be fast approaching when the judiciary will have to stake out a uniform position about when human life begins. one would hope that decision will be made using the best available scientific evidence. kicking the butt of secondhand smoke: why indiana should ban smoking in vemcles carrying minors jennifer l. strange • table of contents i. introduction ............................................................................... 293 a. »'hat is secondhand smoke? .................................................... 294 b. dangers of secondhand smoke: the shift from "smoking is bad for you" to "smoking is badfor others" ................................ 294 1. smoking may be harmfol to your health-focus on the smoker (reports of the surgeon general from the 1960s to the mid-1980s) ................................................................... 294 2. smoking is harmfol to your health and may be harmfol to other8-focus on the gray (reports of the surgeon general from the mid-1980s to the late 1990s) ................. 295 3. beyond a mere annoyance: smoking is harmfol to others­ focus on the effects of shs (current reports of the surgeon general) ............................................................................. 295 c. the influx of smoking bans ..................................................... 297 1. the birth of the "smoking ban" ......................................... 297 2. the growth of the "smoking ban" ..................................... 297 3. the change in the "smoking ban" ..................................... 298 d. giving a voice to the voiceless: protecting children ............. 299 1. the harmfol effect of shs on children ............................... 299 2. actions by states and courts to protect children from exposure to shs ................................................................. 300 3. shs exposure in vehicles: the effects on children .............. 301 ll. moving from the public to the private: the need for regulating private vehicles in order to protect children ....................................................................................... 302 a. two states take the lead: arkansas and louisiana pass smoking bans on vehicles ....................................................... 302 1. arkansas ............................................................................ 302 2. louisiana ........................................................................... 303 b. stretching the ban even farther: a look at bangor, maine and the state of california .............................................................. 303 1. bangor, maine ................................................................... 303 * j.d. candidate, 2009, indiana university school oflaw-indianapolis; b.a., 2005, butler university. 292 indiana health law review [vol. 6:291 2. california .......................................................................... 304 c. jumping on the bandwagon: other states take note of the problem .................................................................................... 304 d. beyond the united states: other countries propose national smoking bans on vehicles carrying minors ........................... 306 1. canada .............................................................................. 306 2. australia ............................................................................ 307 ill. okay to be a nanny: protecting children outweighs personal rights (why arguments against this type of ban fail) .......................................................................•....................... 308 a. is the government going too far by regulating the "private" vehicle?: the rights of the smoker vs. the interests of the child ........................................................................................ 308 1. the privacy argument ........................................................ 308 2. parens patriae: the interests of the child trump the rights of the smoker .......................................................................... 310 b. how will the government enforce a smoking ban on vehicles?: the enforceability argument ................................................... 311 c. breaking down the walls of the "castle"-the government is already regulating the "private" sphere to protect against shs ........................................................................................... 313 1. shs as a nuisance-the increase in smoke-free apartments, condominiums ("condos''), and other rental properties ... 313 2. not protecting against slis may be a violation of the covenant of quiet enjoymentand/or the implied warranty of habitability-landlord/tenant cases ................................... 315 d. a minor restrained in a smoky vehicle is like a prisoner confined to a cell-a parallel to smoking bans in prisons ... 316 n. it is time for indiana to take action: indiana needs top ass a smoking ban on vehicles carrying minors ...................... 319 a. smoking & indiana: the startling statistics ........................... 319 b. common sense legislation: a proposed plan for indiana ..... 319 1. a step in the right direction: the ban that almost was ...... 319 2. where does indiana go from here? ................................... 321 v. conclusion •.•.•.•.••••••..•••..••••....•....•........•.••••.•.•....•....•.....••••.•..•..•.. 323 kid: my mommy says smoking kills. nick naylor: oh, is your mommy a doctor? kid: no. nick naylor: a scientific researcher of some kind? kid: no. nick naylor: well then she's hardly a credible expert, is she? 2009] kicking the buti of secondhand smoke nick naylor: my point is that you have to think for yourself. if your parents told you that chocolate was dangerous, would you take their word for it? children (in unison): no! nick naylor: exactly! so perhaps instead of acting like sheep when it comes to cigarettes, you should find out for yourself.1 i. introducnon 293 smoking bans are not a new concept. the harmful effects of secondhand smoke ("shs") have been known for many years, but it was not until 2006-­ when it was concluded that there is no safe level of shs2that the full scope of the dangers ofshs came to light. it has only been in the past few years that the particularly damaging effects ofshs on children have been fully realized. 3 despite these disturbing new findings, children remain largely unprotected by smoking bans and exposed to the dangers of shs. this note closely examines the newest species of smoking bans: smoking bans in vehicles carrying minors. part i of this note examines the issues of shs, smoking bans, and the effects of shs on children. in part ii, this note surveys the methods employed by various states and cities that have taken the lead and begun to regulate this predominantly private sphere (the vehicle). in part til, this note explores the arguments for and against these smoking bans, including privacy, constitutional, and enforceability arguments. in part iii, this note ultimately suggests that states have a duty to protect children from expo­ sure to shs in vehicles and that the regulations are relatively easy to enforce. part til will also examine situations in which the government is already regulat­ ing the private sphere, such as landlord/tenant cases. further, part m will com­ pare children confined in a smoky vehicle to prisoners confined in a cell and suggests that if prisoners can be spared from shs exposure, then children should also be afforded that protection. in part n, this note will argue that indiana, a large tobacco-producing state,4 should follow the lead of arkansas, louisiana, and california, and pass legislation banning smoking in vehicles carrying minors. in part v, this note concludes that the dangers associated with shs are too great and children are too important to not take the recom­ mended action in regulating activities within the vehicle. 1. 1hank you for smokjng (fox searchlight pictures 2005), available at http://www.foxsearchlight.comlthankyouforsmoldng (scene that depicts a big tobacco spokes­ man/lobbyist talking to a classroom of children about his job as he tries to spin arguments in favor of cigarettes). 2. see infra note 28 and accompanying text 3. see infra notes 29-30 and accompanying text. 4. see infra note 201 and accompanying text. 294 indiana health law review [vol. 6:291 a. what is secondhand smoke? shs, or environmental tobacco smoke, is a "mixture of the smoke given off by the burning end of tobacco products (sidestream smoke) and the main­ stream smoke exhaled by smokers. "5 shs exposure happens in both the public and private spheres. people can be exposed to shs in private areas such as the home, vehicle, or workplace, and in public areas such as bars, restaurants, clubs, and casinos. the exposure of nonsmokers to shs is often referred to as "passive smoking" or "involuntary smoking," rhetorically demonstrating the fact that the majority of nonsmokers are involuntarily exposed to tobacco smoke.6 b. dangers of secondhand smoke: the shift from "smoking is bad for you" to "smoking is bad for others" 1. smoking may be harmfol to your health-focus on the smoker (reports of the surgeon genera/from the 1960s to the mid-1980s) the dangers of smoking were first addressed in the 1964 u.s. surgeon general's report. 7 shs was not addressed until eight years later in the 1972 surgeon general's report.8 in the 1972 report, the "studies supported a con­ clusion that 'an atmosphere contaminated with tobacco smoke can contribute to the discomfort of many individuals. "'9 further, the report contemplated the possibility of harm from sh8-it mentioned that carbon monoxide from ciga­ rette smoke could potentially harm people with chronic heart or lung disease.10 although the 1970s and 1980s marked a period in which it was becoming increasingly apparent that there were serious consequences from exposure to shs, information pertaining to the dangers and effects ofshs was limited, and shs was only briefly mentioned in reports of the surgeon general. for exam­ ple, the 1975 surgeon general's report stated that "smoking on buses and air­ planes was annoying to nonsmokers and that involuntary smoking had potentially adverse consequences for persons with heart and lung diseases. "11 the 1982 surgeon general's report noted that, "[a]lthough the currently avail5. u.s. dep't of realm and human servs., the realm consequences of involuntary exposure to tobacco smoke: a report of 1lie surgeon gen. crr. for disease control and prevention, coordinating ctr. for realm promotion, nat'lctr. for chronic disease prevention and realm promotion, office on smoking and realm (2006), available at http://surgeongeneral.gov/library/secondhandsmokelreport [hereinafter 2006 report] (message from sec'y of health and human servs., michael 0. leavitt). 6. jd. at9. 7. id. at3. 8. id. 9. id. (emphasis added). 10. jd. 11. 2006 report, supra note 5, at 3 (emphasis added). 2009] kicking tile burr of secondhand smoke 295 able evidence is not sufficient to conclude that passive or involuntary smoking causes lung cancer in nonsmokers, the evidence does raise concern about a possible serious public health problem."12 although these reports acknowl­ edged a heightened concern for risks associated with shs, the reports danced around the possibility that shs was more than an annoyance to nonsmokers. further, the 1984 surgeon general's report was the first time the effects of smoking on children were mentioned--the report only briefly reviewed the "mounting information" on parental smoking and its effects on children. 13 2. smoking is harmful to your health and may be harmful to others­ focus on the gray (reports of the surgeon general from the mid-1980s to the late 1990s) the 1986 surgeon general's report marked the first time that shs was the focus of an entire report.14 the report concluded that "involuntary smoking caused lung cancer in lifetime nonsmoking adults and was associated with ad­ verse effects on respiratory health in children."15 the surgeon general at the time, dr. c. everett koop, stated that, ''the right of smokers to smoke ends where their behavior affects the health and well-being of others; furthermore, it is the smoker's responsibility to ensure that they do not expose nonsmokers to the potential harmful effects of tobacco smoke."16 these concerns were echoed by the international agency for research on cancer, the world health organi­ zation, and the national research council.17 since the 1986 report, there has been growing information about the dangers of shs. for example, in 1992, the u.s. environmental protection agency ("epa") classified shs as a known human carcinogen.18 throughout the years, research on shs and its effects on nonsmokers has only confirmed the finding that shs exposure is linked to numerous health problems, as origi­ nally concluded in the 1986 surgeon general's report}9 in 1997, the epa estimated that exposure to shs causes "between 24,300 and 71,900 low birth weight or pre-term deliveries, about 202,300 episodes of childhood asthma (new cases and exacerbations), between 150,000 and 300,000 cases oflower respiratory illness in children, and about 789,700 cases of middle ear infections in children" each year in the united states.20 3. beyond a mere annoyance: smoking is harmful to others-focus on the 12. id. (emphasis added). 13. ld. 14. id. 15. ld. at 6. 16. ld. 17. 2006 report, supra note 5, at 6. 18. ld. 19. ld. at 7. 20. ld. at8. 296 indiana healrn law review [vol. 6:291 effects of shs (current reports of the surgeon general) shs continues to present a public health problem in the united states. in 2006, over 126 million nonsmokers in the united states were exposed to shs. 21 approximately one quarter of all minor children are exposed to shs in their homes. 22 with these staggering statistics, the harmful effects ofshs have become very apparent. what makes matters worse is that people who choose not to smoke are inhaling the same chemicals and cancer-causing substances in shs as people who do smoke.23 this is why nonsmokers can develop lung cancer and heart disease-health conditions that are typically associated with smokers-due to exposure to shs.24 in 2005 alone, approximately 49,000 adults and 430 newborns died from diseases related to exposure from shs.25 further, shs is responsible for "150,000 [to] 300,000 new cases ofbronchitis and pneumonia in children aged less than 18 months . ..26 as a result, approx­ imately 7,500 to 15,000 children are hospitalized annually.27 the truth cannot be ignored: shs is a very real and serious health con­ cern. as the 2006 surgeon general's report concluded: there is no safe level of exposure to shs.28 furthermore, children are particularly vulnerable to the dangers of shs. not only does shs increase the risks of sudden infant death syndrome, acute respiratory infections, ear problems, and more severe asthma in children, 29 but parental smoking may exacerbate such health problems. shs is also responsible for slowed lung growth in children.30 establishing smoke­ free environments is the "most effective method" to prevent exposure to shs. 31 merely isolating smokers and cleaning or ventilating the air is not enough; these measures, while mitigating some of the harm caused by shs, cannot en­ tirely eliminate shs exposure. 32 21. dep't ofhealth and human servs., clrs. for disease control and prevention, smoking & tobacco use: a fact sheet on secondhand smoke (2006). http://www.cdc.gov/tobacco/data _ statistics/fact_ sheet/secondhand_ smoke/ secondhandsmoke.htm [hereinafter fact sheet] (citing 2006 report, supra note 5) (last visited sept 30, 2008). 22. 2006 report, supra note 5. in kentucky, as many as 34.2% of children aged eigh­ teen and younger are exposed to shs in their homes. id 23. vice admiral richard h. carmona, u.s. surgeon general, remarks at the press con­ ference to launch the health consequences of involuntary exposure to tobacco smoke: are­ port of the surgeon general (june 27, 2006). ("secondhand smoke has been found to contain more than 50 carcinogens and at least 250 chemicals that are known to be toxic or carcinogen­ ic.") (remarks available at http:/lwww.surgeongeneral.gov/news/speeches/06272006ahtml). 24. id. 25. 2006 report, supra note 5. in 2005, an estimated 3,000 adult nonsmokers died from lung cancer, 46,000 adult nonsmokers died from coronary heart disease, and 430 newborns died from sudden infant death syndrome-all attributable to shs exposure. id 26. fact sheet, supra note 21. 27. id. 28. 2006 report, supra note 5, at 11. 29. 2006 report, supra note 5. 30. id. at 11. 31. jd. 32. id. 2009] kicking tile burr of secondhand smoke 297 c. the influx of smoking bans 1. the birth of the "smoking ban" as more information about the dangers ofshs has emerged, the "attitude of the public toward and the social norms around secondhand smoke exposure have changed dramatically to reflect a growing viewpoint that the involuntary exposure of nonsmokers to secondhand smoke is unacceptable. "33 as a result, both state and local governments have attempted to curb smoking in public places in an effort to control shs and protect the public from harm. for exam­ ple, california attempted to pass a statewide clean indoor air law via the cali­ fornia clean air act of 1978-the first of its kind by any state. 34 that proposition ultimately failed; however, twenty years later, california successful­ ly banned smoking in bars and restaurants,35 paving the way for other states and municipalities to regulate smoking in public places. 2. the growth of the "smoking ban" as a result of the change in attitudes towards shs, the public has ac­ knowledged a need for smoking bans: restrictions on smoking are now widely embraced by the public due to increased intolerance for involuntary exposure to shs. 36 since california's initial attempt at passing a smoking ban, the united states has seen an increase of similar bans across the country on local, state, and federal levels. in 1988, congress prohibited smoking on all domestic flights. 37 by executive order, smoking was banned in all federal buildings in 1997.38 cities and states across the united states have enacted smoking bans in indoor public places, such as work buildings, restaurants, clubs, and casinos. 39 33. /d. at 667 (emphasis added). 34. mark: j. horvick, examining the underlying purposes of municipal and statewide smoking bans, ind. l.j. 923, 923 (2005) (citing stanton a. glantz et al., the cigarette papers 391 (1996)). 35. /d.; see cal. lab. code § 6404.5 (west 2007). 36. 2006 report, supra note 5, at 668. 37. joni ogle, why smoking bans are a butt to texas: the impact of smoking bans on private property rights and individual freedom, tex. tech l. rev. 345, 352 (2007) (citing jacob sullum, for your own good 16 (1998)); for smoking rules of the federal aviation ad­ ministration, see 14 c.f.r. §§ 121.317 (c), 121.571 (a)(l)(i), 129.29, 135.117(a)(l), 135.127(a), and252.3. 38. /d. (citing jacob sullum, for your own good 16 (1998)); exec. order no. 13058, 62 fed. reg. 43451 (1997). 39. 2006 report, supra note 5, at 668. for example, on march 27, 2003, the city of bloomington, indiana passed a city-wide ordinance banning smoking. monroe county, ind., ordinance 03-06: "smoking in public places and places of employment" (march 27, 2003), available at http://www.smokefteebloomington.orglord0306final.pdf. as of january i, 2005, all public places (including bars and restaurants) and places of employment were smoke-free. jd 298 indiana health law review [vol. 6:291 many colleges, universities, nursing homes, and hospitals have joined the smoke-free movement and have enacted policies that prohibit smoking on cam­ puses.40 the united states military has even adopted smoking restrictions with­ in their indoor facilities.41 by prohibiting smoking in public places, several levels of government have recognized and reinforced the surgeon general's conclusion that merely separating smokers from nonsmokers in public places does not effectively eliminate the health risks associated with shs.42 in 2007, seven states passed legislation that reinforced and expanded existing smoke­ free policies. 43 to date, twenty-two states, the district of columbia, and puerto rico have approved comprehensive smoke-free policies that prohibit smoking in restaurants and bars.44 even tennessee, the "first traditional tobacco grow­ ing state," passed smoking restrictions in 2007 in public places and workplac­ es.4s 3. the change in the "smoking ban" in response to the 2006 surgeon general's report, there has been a recent push for expanding smoking bans to public places that have not been covered by traditional bans. for example, the chicago park district recently passed a smoking ban for parks, playgrounds, and beaches. 46 violators of the ordinance 40. for example, indiana university required all of its university property across the state oflndiana to adopt smoke-free policies for their campuses to go into effect by january 1, 2008. indiana university, tobacco-free iu (nov. 6, 2007), http://smokeftee.indiana.edu/ (last visited sept. 30, 2008). the university stated that "[a]s a public institution ofhigher education with units that research and treat the effects of smoking and tobacco use, iu believes it bas an obliga­ tion to exercise leadership by promoting a healthy, smoke-free environment for its students, employees, and visitors." ld. further, as of2006, there were two nursing homes and sixty-five state hospitals and clinics across the state oflndiana that had adopted 1 000/o smoke-free policies on their campuses. american nonsmokers' rights foundation, 1 000/0smokefree u.s. hospitals and nursing homes (aprill7, 2006), http://www.kidslivesmokefree.org/pdt7smokefreehealthcar e.pdf(last visited sept. 30, 2008). these smoke-free nursing homes, hospitals, and clinics pro­ hibit smoking in facility buildings, outdoor areas. and parking lots in order to protect employees, visitors, and patients from the harmful effects ofshs. id. 41. scott c. wilcox, secondhand smoke signals from prison, 105 mich. l. rev. 2081, 2092 (2007) (citing 2006 report, supra note 5). 42. 2006 report, supra note 5. 43. americanlungassociation,20078ta1elf.gjslatfdac1ionsontobaccoissues mid-term report (july 2007), available at http://slati.lungusa.org/reports/sla ti2007mid termreport.pdt: these states are: lllinois, maryland, minnesota, new hampshire, new mex­ ico, oregon, and tennessee. jd. 44. id. these states are: arizona, california, colorado, connecticut, delaware, hawaii, lliinois, maine, maryland, massachusetts, minnesota, montana, new hampshire, new jersey, new mexico, new york, ohio, oregon, rhode island, utah, vermont, and washington. id. laws in three of the states (oregon, utah, and montana) go into effect in 2009. jd. 45. ld. 46. cbs2, new smoking ban passes in chicago: no lighting up at beaches, parks, playgrounds (oct 17, 2007), http://cbs2chicago.comllocaj/smoking.ban.beaches.2.377241.btml (last visited sept. 30, 2008). 2009] kicking the burr of secondhand smoke 299 will be forced to pay a $500 fine. 47 chicago park district superintendent, tim mitchell, stated "i have a lot of sympathy for smokers, but not when second­ hand smoke affects the health of other people.'.48 although chicago's ban pro­ tects the health of residents both young and old from shs, it is worth noting that its protective force applies largely to children, the typical patrons of parks, playgrounds, and beaches. england and other parts of the united kingdom have also jumped on the non-traditional bandwagon. england recently passed a smoking ban on compa­ ny vehicles. effective july 1, 2007, smoking in company vehicles in england is prohibited if the vehicle transports more than one person.49 wales and north­ em ireland passed a similar ban; scotland has a more relaxed ban that applies only to vans. 50 although no state or municipality has passed such a ban in the united states, it is foreseeable that company vehicles could soon be regulated in the united states as well. d. giving a voice to the voiceless: protecting children 1. the harmfol effect of shs on children although in recent years the dangers of shs have come to light and states and municipalities have responded with increased smoking bans, children re­ main an "exposed population."51 while smoking bans in public places (i.e. bars and restaurants) address a legitimate public health concern, they do not ade­ quately address the effects of shs exposure on children because children are not typically patrons in the types of public places regulated by the current smoking bans. as a result, "reductions in exposure [to secondhand smoke] have been slower among young children than among adults during the last dec­ ade."sz shs is particularly dangerous to children because their bodies are still de­ veloping. it has been suggested that shs may be even more harmful to child­ ren than adults because children have weaker immune systems.53 "[d]ue to [children's] smaller airways and greater demand for oxygen, they may be more vulnerable to respiratory diseases."54 exposure to shs "increases the risk of 47. id 48. id. 49. pinsent masons, smoking ban-company veidcles (england and appucation in olher parts of 1he uk) (june 2007), available at http://www.pinsentmasons.com/media/ 134379445.pdf. 50. !d. 51. 2006 report, supra note 5, at 668. 52. 2006 report, supra note 5, at 667. 53. press release, harvard school of public health, secondhand smoke in cars may lead to dangerous levels of contaminants for children {oct. 5, 2006) [hereinafter harvard stu~], http://www.hsph.harvard.edu/news/press-releases/2006-releases/pressl0052006.html (last visited sept. 30, 2008) 54. id. 300 indiana health law review [vol. 6:291 serious respiratory problems in children, such as greater number and severity of asthma attacks and lower respiratory tract infections, and increases the risk for middle ear infections."55 while most adults are able to decide for themselves whether to be around shs in an environment that is not regulated by smoking bans, children are not permitted that luxury. in effect, children are unable to voice their concerns about shs and are unable to protect themselves. 2. actions by states and courts to protect children from exposure to shs recognizing that children are especially vulnerable to shs exposure, states and even the courts have taken measures to protect children from expo­ sure. several states have passed legislation that prohibits smoking around children in child care or foster care settings. 56 the texas administration code states that "[p ]eople must not smoke or use tobacco products at the child-care center, on the premises, on the playground, in transportation vehicles, or during field trips [of, or sponsored by, these facilities]."57 the washington revised code states that smoking is prohibited "in the living space of any home or facil­ ity caring for [foster] children and in motor vehicles while transporting [foster] children ... [foster parents] may permit adults to smoke outdoors away from children. "58 the indiana code states that smoking is also prohibited "in a school bus during a school week or while the school bus is being used for ... [school services]" such as transporting school children to and from school, school athletic games or contests, or other school functions. 59 some courts have addressed shs in child custody decisions. in the case of in re julie anne, 60 a minor child was exposed to shs by adults who smoked around the child, in public as well as in their home.61 the ohio court, in custo­ dy and visitation proceedings pertaining to the child (who was in good health), ordered the parents to not smoke around the child. 62 the court further ordered the parents to not allow others to smoke around the child. 63 in issuing its order, the court acknowledged that shs is a very real threat to the health of children and should be given consideration in determining custody of the child.64 fur55. 2006 report, supra note 5. 56. pambelluck, maine city bans smoking in cars carrying children, n.y. times, jan. 19, 2007, available at http://query.nytimes.com/gst/fullpage.html?sec=health&res=9d04e3d c1e30f93aa25752coa9619c8b63 (last visited sept. 30, 2008). "at least seven states, in­ cluding several with large numbers of smokers like texas, oklahoma and alaska, prohibit or sharply restrict smoking around foster children in homes, cars or both. some [states] require homes or cars to be smoke-free for 12 hours before a foster child enters." !d. · 57. 40 tex. admin. code§ 746.3703(d) {2008). 58. wash.admin.code388-l48-0185 (2008). 59. ind. code§ 16-41-37-4 (2008). 60. 780 n.e.2d 635 (ohio misc. 2d 2002). 61. id at 640. 62. /d. 63. /d. 64. /d. 2009] kicking the burr of secondhand smoke 301 ther, the court stated that "[a] considered analysis of the law ... leads to the inescapable conclusions that a family court that fails to issue court orders re­ straining persons from smoking in the presence of children within its care is failing the children whom the law has entrusted to its care. •.65 in dematteo v. dematteo, a case in new york, a minor child complained about his mother smoking in his presence during visitations. 66 the court held that the interests of the child were best served ifhe was not exposed to shs by his parents. 67 the court further held that the mother could not smoke in her home before visits with her child, and that both the mother and father could not smoke in their vehicles if the child was present. 68 in its decision, the court noted that "there is 'a substantial body of research showing that breathing second-hand smoke is a significant health hazard for non-smokers. "'69 shs presents a very real health concern, as evidenced by these courts and others' willingness to factor in shs into a child custody and/or visitation decision. 70 3. shs exposure in vehicles: the effects on children in spite of the attempts by states and courts to shield children from the dangers of shs, children are still exposed to shs in their homes and in ve­ hicles. because this note is in favor of smoking bans on vehicles carrying mi­ nors, this section of the note focuses specifically on shs exposure in vehicles and its damaging effects on children. in the "first study to measure shs in cars in real driving conditions," researchers from the harvard school of public health concluded that "shs in cars poses a potentially serious threat to child­ ren's health."71 approximately 35% to 45% of children are regularly exposed to shs in their homes and in cars. 72 "[s]moking in cars can produce unsafe levels of shs. even with the driver's window slightly open, ... concentrations [of 65. /d. at 641. (emphasis added). 66. dematteo v. dematteo, 749 n.y.s2d 671 (n.y. sup. ct. 2002) 67. id.at619. 68. id 69. id. at 648. 70. see heagyv. kean. 864 n.e.2d 383 (ind. ct. app. 2007)(courtordered the mother to reftain from smoking in the child's presence and after alleged violations of the order, the father requested a modification of the custody arrangements); unger v. unger, 274 n.j. super. 532 (1994) (noting that parental smoking can be factored into a custody determination); johnita, m.d. v. david, d.d., 740 n.y.s.2d 811 (n.y. app. div. 2002) (court took judicial notice of exposure to shs after a thirteen-year-old asked the court that he not be exposed to shs during visits with his mother); becker v. becker, 925 p .2d 162 (or. ct. app. 1996) oudgment of disso­ lution contained a provision prohibiting both parents and third parties from smoking cigarettes around the children). 71. harvard study, supra note 53. the study consisted of forty-five driving trials, which averaged about an hour each. id during the trials, volunteers smoked cigarettes while driving. id throughout the study, "measurement devices were positioned in an empty child restrainer seat at simulated head level" that detected and measured shs levels. ld 72. id. 302 indiana health law review [vol. 6:291 shs] hit levels rated 'hazardous' by the ... [epa]. "73 even "smoking a single cigarette for just five minutes could produce potentially harmful ... levels [of shs]."74 "the smoke particle levels ... measured are alarming and are above the threshold for what's considered unhealthy for sensitive groups-people like children and the elderly ... adults who smoke while driving their children may be harming them more than they realize."75 it has been found that shs expo­ sure for mere seconds is still incredibly dangerous and can cause children to have asthma attacks.76 to make things worse, children are often physically re­ strained in smoky cars, with shs levels similar to that of smoke-filled bars or restaurants.77 the harvard school of public health study, when considered alongside the 2006 surgeon general's report, confums the fact that states need to speak and act on behalf of children to protect them from shs in vehicles. it. moving from the public to the private: the need for regulating private vehicles in order to protect children a. two states take the lead78: arkansas and louisiana pass smoking bans on vehicles i. arkansas arkansas was the first state to pass legislation aimed at protecting children from shs exposure in vehicles. 79 in april2006, then-governor of arkansas, mike huckabee, signed into law house billl 046, which prohibits smoking in a vehicle carrying a child less than six years old or weighing less than sixty pounds. 80 the bill, which was sponsored by rep. bob mathis (d-ar), a for­ mer smoker, received "overwhelming support" and passed in less than two 73. !d. 74. !d. 75. !d. 76. !d. 77. harvard study, supra note 53. 78, the territory of puerto rico has also joined the "growing national and international trend" to enact legislation prohibiting smoking in vehicles. tobacco public policy center, ar­ kansas prohibits smoking in cars carrying young children (april 2006), http://www.law.capital.edu/fobacco/newsletter/april2006/feature2.asp (last visited sept. 30, 2008). puerto rico's law, which took effect in march 2007, prohibits smoking in vehicles with children under the age of thirteen present. id 79. rep. peter daley (d-penn.) was "the first [legislator] in the nation to propose a ban on smoking in vehicles carrying children-in 1988, after he had a cancer removed from his throat that he blamed on whiffs from his mother's cigarettes." andrew knapp, states go after smoking in vehicles with kids, stateline (march 6, 2007), http://www.stateline.orgllive/details/ sto­ ry?contentld= 186298 (last visited sept. 30, 2008). the e:tl'ort, however, was successfully op­ posed by the american civil liberties union of pennsylvania. ld 80. tobacco public policy center, supra note 78; see also ark. cone ann. § 20-27-1903 (2008). 2009] kicking the burr of secondhand smoke 303 days.81 violators face fines of up to twenty-five dollars, but the fine for a first offense can be waived if a violator proves that he has taken measures to stop smoking. 82 governor huckabee has acknowledged that this bill clearly protects children from the dangers of shs. 83 2. louisiana louisiana was the second state to ban smoking in vehicles carrying child­ ren. similar to the law in arkansas, louisiana's law is targeted at protecting children restrained in car seats. according to the statute, it is unlawful for the operator or any passenger in a motor vehicle to smoke cigarettes, pipes, or ci­ gars in a motor vehicle when a child who is required to be restrained in a child safety seat is also present in such vehicle, regardless of whether the windows of the motor vehicle are down; violators face a fine of up to $150 per offense. 84 violation of the law is considered a primary offense; therefore, police officers may stop but not search a vehicle if a violation is occurring.85 louisiana, although following arkansas's lead in passing legislation, took a stricter approach to fines for violators of the ban. by imposing stricter fmes and penalties, louisiana gets the message across that they do not tolemte expos­ ing children to shs. b. stretching the ban even farther: a look at bangor, maine and the state of california 1. bangor, maine in january 2007, bangor, maine became the first city in the united states to ban smoking in vehicles carrying children. 86 bangor's ordinance extended the ban beyond children in car seats to include vehicles travelling with anyone under the age of eighteen. 87 a proponent of the ordinance, council member patricia blanchette, stated, 81. !d.; knapp, supra note 79. 82. ark. code ann.§ 20-27-1904 (2008). 83. tobacco public policy center, supra note 78. 84. see la. rev. stat. ann. § 32:300.4 (2006). 85. la. rev. stat. ann. § 32:300.3 (2006). 86. meg haskell, council supports smoking ban in cars, bangordailynews, jan. 9, 2007, at a 1. other municipalities, including keyport, new jersey, west long branch borough, new jersey, and rockland county, new york have since enacted laws (of varying degrees) prohibiting smoking in vehicles carrying children. rob cunninham & michael derosenroll, laws banning smoking in vehicles carrying children-international overview, canadian cancer society (aug. 19, 2008), http://member.globalink.org/files/file-141676-l.pdf(last vi­ sited sept. 30, 2008). 87. knapp, supra note 79. 304 indiana health law review i am tired as a taxpayer of paying for people to take their children to the emergency room because they've had an asthma attack. why are we taking these very, very fra­ gile little bodies [of children], putting them in a confined area and allowing people to blow smoke into their lungs?88 [vol. 6:291 blanchette, a smoker herself, further stated that, "[p ]eople who smoke with a child present in the confmed space of a car or truck might as well be deliberate­ ly trying to kill that child. let's step up to the plate and lead; our children are worth the fight. "89 under the bangor law, violating the ordinance is a primary offense, thus, police officers can make a traffic stop if they observe a violation, and violators are then subject to a $50 fine. 90 as of october 2007, no citations had been issued in bangor.91 2. california the state of california also recently passed a smoking ban that prohibits smoking in vehicles with minors, making it the third state to pass such legisla­ tion.92 the bill went into effect in california on january 1, 2008.93 the law makes it a secondary offense to smoke in a vehicle with children present, which means that a person would have to be stopped for some other offenselike speeding or reckless drivingin order to be penalized for smoking. 94 drivers face fines of up to $100 for violating the law.95 c. jumping on the bandwagon: other states take note of the problem since arkansas first passed its legislation banning smoking in vehicles with children present, at least sixteen other states have considered similar bans.% some of the proposals for smoking bans have drawn the line at children 88. belluck, supra note 56. 89. haskell, supra note 86. 90. knapp, supra note 79. 91. new england in brief, boston globe, oct. 22, 2007, at 2b. 92. 5am morning news (fox 2 ktvu-ca broadcast oct. 11, 2006). since the writing of this note, maine became the fourth state to pass legislation regulating the vehicle. although it did not enact a law as restrictive as the ordinance passed in its pioneer city of bangor, maine, the state's new law prohibits smoking in vehicles when a child under the age of sixteen is present. me. rev. stat. ann. tit. 22, § 1549 (2008). because the law is relatively new, violators will receive a written warning until august 31,2009. jd as of september 1, 2009, violators can be assessed a $50 fine. ld 93. 5am morning news (fox 2 ktvu-ca broadcast oct. 11, 2006). 94. ld. 95. jd. 96. janine defao, proposed car-smoking ban angers foes of 'nanny' laws, san francisco chronicle, march 26, 2007, at a-1, available at http://sfgate.com/cgi­ bin/article.cgi?f=/ c/a/2007/03/26/mngolori821.dtl .. 2009) kicking tile buit of secondhand smoke 305 restrained in car seats (similar to the bans in arkansas and louisiana), while other states have proposed more extensive bans to include vehicles carrying children up to the age of eighteen (similar to bangor, maine and the state of califomia).97 not only have proposals for such bans differed on the age/weight of protected children, but penalties for violating proposed bans have also va­ ried. according to proposed legislation in kansas, violators in the state would be warned for the first offense, while offenders under new jersey and new york legislation could be fined $500.98 the proposed legislation in new york allows penalties for third-time offenders (in the same year) that include up to a $1,500 fine or ten days injai1.99 considering that arkansas and louisiana have successfully enacted their bans, it is possibleand reasonablefor other states to follow suit and enact smoking bans in vehicles carrying children. senator scott mccoy (d-ut), who is considering a ban in utah similar to arkansas's ban, stated that"[ w ]hen we talk about children, they're some of the most vulnerable people that can be ex­ posed to secondhand smoke. now that i know another state has done it, it's also obvious that it is practicable or it can be done. there's certainly a precedent for it."100 senator raymond lesniak (d-nj), who sponsored a pro­ posed ban in new jersey, stated that "[t]here is no more important law en­ forcement responsibility than protecting children. ,tot senator david haley (d­ ks), who amended a proposed statewide smoking ban to include vehicles car­ rying minors, stated that, ''the act of smoking in a car with young children [is] tantamount to child abuse. " 102 senator haley went on to state that children are "innocent victims" in these situations, and that it is time to hold adults account­ able for their actions that are adversely affecting children.103 even children, when asked, see that banning smoking in vehicles carrying children is a matter of common sense. for example, in connecticut, justin k vadas, at nine-years-old, emailed his state representative (with help from his mom) and suggested that the state ban smoking in vehicles carrying children.104 justin stated, "[i]t came to me, if you can't drink or talk on the cell phone while driving, how come you can still smoke? ... [i]t's ... bad for [children's] lungs 97. knapp, supra note 79. 98. !d. 99. !d. 100. brock vergakis, ban smoking in cars with kids?, casper star tribune, april22, 2006, available at http://www.casperstartribune.netlarticles/2006/04/22/news/regional! i9fl28 2id5db 18848725715700558e2b.txt. 1 01. ronald smothers, new jersey senate panel supports penalty for smoking in cars with children aboard, new york times, june 8, 2007, at 84, available at http://www.nytimes. com/ 2007 /06/08/nyregion/08smoke.html. 102. anna staatz, statewide smoking prohibition would include cars with kids, the topeka capital-journal, jan. 25, 2007, available at http://www.cjonline.com/stories/012507 i sta l4l395600.shtml. -103. /d. 104. belluck. supra note 56. 306 indiana health law review [vol. 6:291 because their lungs are so small."105 before presenting the proposal to his state representative, justin circulated a petition, collecting signatures from his class­ mates and the mayor.106 d. beyond the united states: other countries propose national smoking bans on vehicles carrying mmors 1. canada in 2007, at the annual meeting of the canadian medical association ("cma"), doctors recommended a national smoking ban on vehicles carrying minors to protect children and their young lungs from harm.107 dr. atul kapur recomntended the ban, which received great support from the cma.108 in his recommendation, dr. kapur noted the danger of shs to children in vehicles: the risk of second-hand smoke is quite clear to everyone in this room. there are few areas where children are still exposed [to shs, but] one of them is vehicles. they [children] don't have a choice about whether to be ex­ posed or not and because of the concentrated atmosphere and the enclosed space, the risk is much higher.109 a pediatrician at the meeting, sandra luscombe, declared that "[t]his is a child protection issue. "110 ms. luscombe stated later in an interview that the recom­ mended law "would be no more difficult to enforce than ones requiring seat­ belt usage and prohibiting drivers from talking on cellular phones."m although canada has not yet passed a national smoking ban on vehicles carrying minors, it appears that the majority of the country favors such legisla­ tion. in late 2007, two provinces, ontario and british columbia, introduced smoking bans aimed at protecting children from shs exposure in vehicles.112 furthermore, in december 2007, nova scotia became the first province to ac­ tually enact a smoking ban on vehicles carrying minors.113 nova scotia's law 105. /d. 106. /d. 107. janet steffenhagen, ban smoking in cars with kids: doctors, die v ancouversun, aug. 23, 2007, available at http://www.canada.comlvancouversunlstory.html?id=5d11855c7641-4085-bllc-ad4686022def&k=36414&p=l. 108. id 109. /d. 110. /d. 111. id 112. rob peters, canadians want smoking bans in cars with kids: poo, now public(jan. 17, 2008), http://www.nowpublic.com/life/canadians-want-smoking-ban-cars-kids-poll (last visited sept. 30, 2008). 113. id 2009] kicking me burr of secondhand smoke 307 defines a "minor'' as anyone under the age of nineteen.ll4 in addition to the actions of these provinces, a national poll taken by the canadian cancer society ("ccs") in january 2008, indicated that 82% of canadiansincluding 69% of candian smokers-support the movement towards eliminating shs exposure in vehicles when children are present 115 it is clear that the majority of cana­ dians think it is necessary to regulate smoking in vehicles in order to protect children.116 2. australia the australian medical association ("ama") has also recommended that australia prohibit smoking in vehicles carrying minors.117 in 2006, a poll indi­ cated that almost 90% of australians supported such a ban.118 furthermore, several states in australia have introduced smoking bans on vehicles carrying minors! 19 on may 31, 2007, south australia became the first state in the country to pass a ban prohibiting smoking in vehicles when children under the age of sixteen are present.120 violators of the south australian law are subject to $75 on-the-spot fines and can be forced to pay up to $200 for violating the law.121 south australia advertised its new legislation with posters that read, "[ s ]moke with kids in the car and you'll cough up a fine. "122 in announcing the enactment of the state law, south australia's mental health and substance abuse minister, gail gago, said that"[ c]hildren can spend many hours in cars each week and often do not have a choice when it comes to traveling with smokers."123 further, ms. gago stated that "[m]ost adults are responsible when it comes to their child's health but the few that smoke with children in the car are placing their child at considerable risk :from passive smoking."124 other australian states have also acknowledged the impact of shs on children and have taken steps toward enacting similar legislation. for example, victoria, a state that is generally one of the toughest on shs exposure, has been encouraged by the amato follow the lead of south australia and pass legisla114. /d. 115. /d. 116. see id. according to rob cunningham, senior policy analyst for ccs, "[t]hese poll results clearly tell us that canadians are ready for action to protect the health of children." /d. 117. tobacco public policy center, supra note 78. 118. /d. 119. /d. 120. media release from s. austl.'s minister for mental health and substance abuse, hon. gail gago, news: new smoke-free cars law begins today (may 31, 2007) [hereinafter s. austl. media release] available at http://www.premier.sa.gov.aul news.php?id= 1671. 121. /d. 122. gov't ofs. austl., dep't of health, smoke-free cars, http://www.tobaccolaws.sa. gov.au/ default.aspx?tabid=163 (last visited sept. 30, 2008). 123. s. austl. media release, supra note 120. 124. tobacco public policy center, supra note 78. 308 indiana health law review [vol. 6:291 tion banning smoking in vehicles when children are present. 125 ama victoria president, dr. mark yates, stated that"[ w ]bile people are far more aware of the harm caused by smoking, there are still far too many people exposing children to cigarette smoke."126 furthermore, ama west australia president, paul skerritt, referring to children as the ''forgotten victims witbin the passive smok­ ing debate," has strongly encouraged legislation that bans parents from smoking while driving with their children.127 mr. skerritt has poignantly compared a child restrained in a vehicle filled with shs to someone ''being locked up in a mobile gas chamber."128 ill. okay to be a nanny: protecting children outweighs personal rights {why arguments against this type of ban fail) a. is the government going too far by regulating the "private" ve­ hicle?: the rights of the smoker vs. the interests of the child 1. the privacy argument considering that there is no safe level of exposure to shs and children are more susceptible to the dangers of shs, 129 it seems reasonable to enact smoking bans on vehicles carrying minors. this is especially true because ve­ hicles are a confined space. critics of this particular type of smoking ban (and smoking bans in general), however, argue that this is the ultimate form of"nan­ ny government" or "legal paternalism. "130 because smoking bans on vehicles carrying minors reach into a traditionally private sphere, some worry that the government is blurring the line between the types of behaviors that can and cannot be regulated (or should and should not be regulated). in response to smoking bans in vehicles, the legislative director for the american civil liber­ ties union of pennsylvania asked, "[w]hen are we going to stop and draw the line? at some level, the people have to be responsible for what they do. we shouldn't use the law to enforce what we think is better behavior. "131 it has also been argued that by passing this type of smoking ban, states are trying to 125. press release from the ama victoria, doctors support smoking ban in cars carrying children (dec. 14, 2006), http://www.amavic.eom.au/page/media/wbatsnew/doctorssupport smokingbanincarscarryingchi1dren (last visited sept. 30, 2008). 126. id. 127. action on smoking and health, australian medical association pushes for smoking ban in cars carrying children (march 16, 2005), http://no-smoking.org/march05/03-29-05l.html (last visited sept. 30, 2008). 128. id. 129. 2006report,supranote 5,at ii. 130. ogle, supra note 37, at 347. "legal paternalism occurs when the government at­ tempts to shield citizens from their own choices rather than to protect citizens' freedom of choice." id. at 352 (citing douglas j. den uyl, smoking, human rights, and civil uberties, in smoking: who has the right? 267, 271 (1998)). 131. knapp, supra note 79. 2009] kicking the butt of secondhand smoke 309 regulate in an arena that is better left to parents. 132 robert best of smoker's club inc., a smokers' rights group, asked, "[w]ho is the state to tell you how you can and cannot raise your children?"133 mr. best further stated, "[t]here' sa fine line between protecting my child and moving in to raise my child. a car is private property ... what will they do next, say you can't smoke in your home if you have kids in it?"134 opponents of smoking bans in vehicles are predominantly concerned with privacy-people do not want the government telling them what to do in their "private" lives. justice brandeis once referred to the right of privacy as the right "to be let alone---the most comprehensive of rights and the right most va­ lued by civilized men."135 within this right is the notion that "outside areas of plainly harmful conduct, every american is left to shape his own life as he thinks best, do what he pleases, go where he pleases. "136 echoing the thoughts of justice brandeis and driving the arguments against smoking bans on vehicles is the premise that we, as citizens of the united states, should be free from government intrusion into our personal lives. an extension of this premise is the common belief that a person's home is their "castle" and within their "cas­ tle," a person can do whatever he wants. presumably, a private vehicle is part ofthe "castle." while the supreme court has repeatedly recognized the value of personal decisions and the right to privacy, 137 the right to privacy is not absolute. 138 con­ sequently, merely because an action occurs within the "private" sphere (i.e. the vehicle), it does not necessarily follow that the action will be shielded from government interference. instead, this protection depends on the determination that a fundamental right is implicated. in palko v. connecticut, 139 the court defined a fundamental right as an interest that is "implicit in ordered liberty"140 such that "neither liberty nor justice would exist if ... [it was] sacrificed."141 elaborating on this defmition, the court in griswold v. connecticut stated that it is necessary to look to the ''traditions and conscience of [the] people" to de­ termine that a privacy interest is a fundamental right. 142 132. defao, supra note 96. 133. id. 134. id. 135. olmstead v. united states, 277 u.s. 438, 478 (1928). 136. kent v. dulles, 357 u.s. 116, 126 (1958). 137. see griswold v. connecticut, 381 u.s. 479 (1965)(recognizingarighttousecontra­ ceptives); stanleyv. georgia, 394 u.s. 557 (1969)(recognizingarighttopossessobscenemate­ rials within the home). 138. roe v. wade, 410 u.s. 113 (1973); see also bowers v. hardwick. 478 u.s. 186 (1986) (holding that there is no right to engage in homosexual sodomy within the home if it is prohibited by the state). 139. 302 u.s. 319 (1937) (holding that the prohibition against doublejeopardywas not a fundamental right). 140. !d. at 325. 141. id. at 326 (quoting twiningv. new jersey, 211 u.s. 78,99 (1908)). a fundamental right warrants the strictest standard of review. id. 142. griswold, 381 u.s. at 487. 310 indiana heal til law review [vol. 6:291 with regard to smoking bans, "[a]lthough tobacco enjoys a long tradition in american history, the 'conscience of the people' supports protecting children from the hazards of second-hand smoke."143 regardless, the courts have al­ ready determined that smoking is not a fundamental right.144 because there is no fundamental right to smoke, a smoking ban on vehicles carrying minors must only bear a rational relation to a legitimate government objective in order to be valid. prohibiting smoking in vehicles occupied by children furthers the government's interest in protecting the child from the dangers ofshs. thus, smoking bans on vehicles are rationally related to the government's legitimate objective and do not impermissibly violate privacy rights. 2. parens patriae: the interests of the child trump the rights of the smoker although people have the right to engage in adult and legal decisions (i.e. smoking), that right "does not include the right to inflict health-destructive se­ condhand smoke upon other persons, especially children who have no choice in the matter."145 because there are no fundamental rights involved with the present issue, smoking bans on vehicles create tension between two sets of in­ terests: the smoker and the child. this begs the question: in balancing the smoker's interests with that of the child, which interest ultimately prevails? furthermore, can and should the state regulate this arena? as previously mentioned, courts have reached into the private sphere and repeatedly considered parental smoking when making decisions related to cus­ tody and visitation proceedings.146 because children are often considered to be a ''voiceless" group, courts have reached into the private sphere in order to pro­ tect the best interests of the child. the doctrine of parens patriae is the ''fun­ damental rule of law that underlies our system of family courts and juvenile justice, providing that the state is 'the ultimate parent' of children within the care of the juven'ile court. "147 the state, acting as parent, has an "urgent inter­ est"148 in the welfare of the child, and must act to protect the child.149 "'it is the interest of youth itself, and of the whole community, that children be ... safe­ guarded from abuses .... "'15° courts have held that "when the interests of the parent and the child conflict to the point where the child is threatened with 143. michele l. tyler, blowing smoke: do smokers have a right? limiting the privacy rights of cigarette smokers, 86 geo. lj. 783, 796 (1998). 144. in re julie anne, 780 n.e2d at 655; see also 66 al.r. 5th validity, construction, and application of restrictions on use or possession of tobacco products in co"ectional facilities 237 (1999) (annotation citing to cases that have held that smoking is not a fundamen­ tal right). 145. inrejulieanne, 780n.e.2dat656. 146. see id at 635; dematteo, 749 n.y.s.2d 671. 147. in re julie anne, 780 n.e.2d at 653. parens patriae means "the state as parent." jd 148. /d. (citing lassiterv. dep't of soc. serv.,452 u.s. 18,27 (1981)). 149. /d. (citing palmore v. sidoti, 466 u.s. 429,433 (1984)). 150. /d. at 655 (quoting prince v. massachusetts. 321 u.s. 158, 165,170 (1944)). 2009] kicking the burr of secondhand smoke 311 hann[,] the state has an obligation to protect the welfare of the child."151 under the doctrine of parens patriae, the state has a positive obligation and a duty to protect children from the dangers ofshs.152 because children are often involuntarily exposed to shs, the harm resulting from such exposure is "egregious. "153 considering that it has been determj.ned that shs is particularly detrimental to children, the interests of the child trump the non-fundamental privacy interests of the smoker. as is evident, some people are not entirely comfortable with the govern­ ment or the state reaching into the private sphere in this manner. however, smoking bans on vehicles carrying minors make sense-these bans protect children from a very real danger. kathleen dachille, director of the legal re­ source center for tobacco regulation, litigation & advocacy at the university of maryland school of law, said ''(t]here are times when it's appropriate to regulate what people can do in their home. the state is responsible for that child."154 further, in response to critics of smoking bans on vehicles, richard greene, mayor of bangor, maine,155 stated: i've heard people [critics] say it's the smoke police or the gestapo. i think it boils down to common sense: smoking is not good for you. certainly if you have young children who are in the process of developing and growing, it's even worse for them. you wouldn't s~, 'hey, here's a bottle of mercury. go bob it around! by passing smoking bans and regulating the ''private" vehicle, the state is acting like a "nanny'' or assuming a ''paternal" role, which is acceptable in this context because the health interests of the child are being protected. further­ more, this is the role of the state-if the state does not step in to protect children from the dangers of shs, then who will? b. how will the government enforce a smoking ban on vehicles?: the enforceability argument critics of smoking bans on vehicles carrying minors also argue that such a 151. ld. (emphasis added) (citing michael s. wald, state intervention on behalf of "neg­ lected" children: standards for removal of children from their homes, monitoring the status of children in foster care, and termination of parental rights, stan. l. rev. 625, 638 (1976)). 152. id. 153. in re julie anne, 780 n.e.2d. at 652. 154. emily bazar, laws prohibit smoking around children, usa today, nov. 28,2006, available at http://www.usatoday.com/newslhealtb/2006-11-27 -smoking-bans_ x.htm. 155. as previously mentioned, bangor, maine was the first city to ban smoking in vehicles carrying minors. haskell, supra note 86. 156. belluck, supra note 56. 312 indiana health law review [vol. 6:291 ban would be difficult to enforce. for example, ben henby, a lobbyist for the california organization of police and sheriffs, has said, "[ w ]hile we support the concept [of smoking bans on vehicles] because we're concerned about things that are cancer-producing, it's almost impossible to enforce."157 this argument fails, however, considering that states are already regulating the ''pri­ vate" vehicle and enforcing seatbelt and helmet laws under the "police power'' of the united states. 158 in states where it is a primary offense159 not to wear a seatbelt, a law en­ forcement officer has the authority to pull over a driver that appears to be vi­ olating the law (i.e. not wearing a seatbelt).160 similarly, if a state classifies smoking in vehicles with children present as a primary offense, a law enforce­ ment officer would have the same authority to pull over a driver if the officer witnesses the driver violating the smoking ban (i.e. smoking a cigarette with a child in the vehicle). moreover, it appears to be easier for a law enforcement officer to enforce a smoking ban on vehicles than it is to enforce seatbelt laws because after ave­ hicle stop is made for violating a smoking ban, evidence of the violation re­ mains, such as a cigarette butt or cigarette ashes. while it is true that a person who is pulled over can attempt to conceal his violation (i.e. quickly put on a seatbelt if he was not previously wearing one or dispose of cigarette butts and ashes), it is difficult for a person who has been smoking to rid the vehicle of the smell of cigarette smoke. thus, if a state can enforce seatbelt and helmet laws, the state can just as easily enforce smoking bans on vehicles. even if a state classifies the violation as a secondary offense, 161 the ban is still equally enforce­ able for the reasons previously stated. 157. defao, supra note 96. 158. the tenth amendment of the united states' constitution addresses the powers re­ served to the states, and as such, "recognizes the states' authority to regulate public health, safe­ ty, welfare, and morals through what is called the police power." ogle, supra note 37, at 357; see u.s. const. amend. x. 159. a "primary offense" means a police officer can stop but not search a vehicle if a viola­ tion is occurring. see la. rev. stat. ann. § 32:300.3 (2006); h.b. 1046, i st spec. ses. (ark. 2006). 160. id. 161. a "secondary offense" means a person would have to be stopped for some other of­ fense in order to be penalized for smoking. see sam morning news, supra note 92. 2009] kicking the buit of secondhand smoke 313 c. breaking down the walls of the "castle"-the government is already regulating the "private" sphere to protect against shs 1. shs as a nuisance162 -the increase in smoke-free apartments, condomi­ niums ("condos"), and other rental properties although people object to smoking bans because they blur the line be­ tween public and private conduct, the fact remains that the "private" home is already being regulated; therefore, why should the ''private" vehicle be immune from regulation? as the issue ofshs and its harmful effects has become more pressing over the past few years, the united states has seen an increase in smoking bans on rental properties.163 these types of smoking bans have been enacted to protect tenants (present and future) from shs that they could poten­ tially be exposed to by living in close proximity with others-a defining charac­ teristic of rental properties.164 nationwide, forty-eight public housing authorities have enacted smoke-free policies.165 because it is becoming com­ mon for rental properties to have some form of a smoking restriction, 166 it is clear that people are acknowledging a right to breathe air free ofshs, especial­ ly when the air is inside one's home. many landlords, rental associations, and even cities have taken it upon themselves to ban smoking in their rental units, thus, curtailing non-smokers' 162. a ''nuisance" is defined as a "condition, activity, or situation (such as loud noise or foul odor) that interferes with the use or enjoyment of property; esp., a non-transitory condition or persistent activity that either injures the physical condition of adjacent land or interferes with its use or with the enjoyment of easements on the land or of public highways." black's law dictionary (8th ed. 2004). 163. jim buchta, condominium owners tell smokers: ta/ce it outside, star tribune, feb. 13, 2008, available at http://www.startribune.com/local/15617577 .html; see also wendy koch, neighbor tenants tangle over tobacco, usa today, oct. 3, 2007, at 3a [hereinafter koch 1 ], available at http://www.usatoday.com/newslnation/2007 -1 0-02-nosmoke _ n.htm (as of2007, tens of thousands of apartments and condos had enacted smoke-ftee policies). 164. see buchta, supra note 163; koch 1, supra note 163. 165. koch 1, supra note 163. 166. in fact, utah code expressly authorizes smoking prohibitions in a rental agreement or lease and gives condominium associations the authority to restrict smoking in units, common areas, and facilities. see utah code ann.§ 57-22-5 (1) (h) (1997) and§ 57-8-16 (7) (1997). further, utah even defines shs as a nuisance in its code: secondhand smoke is defined as a nuisance when it drifts into any residen­ tial unit a person rents, leases, or owns, from another residential or com­ mercial unit more than once in each of two or more consecutive seven-day periods, and which is injurious to health, indecent, offensive to the senses, or an obstruction to the free use of property, so as to interfere with the com­ fortable enjoyment oflife or property. a nuisance may be the subject of an action. this does not apply to residential rental units available for tempo­ rary rental or hotel or motel rooms. the cause of action is waived if the ren­ tal agreement explicitly says tobacco smoke may drift into the apartment. utah code ann.§ 78-38-1 (1997). 314 indiana healtii law review [vol. 6:291 exposure to shs. in michigan, more than 600 apartments and condos (cover­ ing at least 6,000 units) have decided to ban smoking on their property-this figure increased :from zero smoke-free rental properties in 2003.167 in maine, 37% oflandlords have enacted smoking bans on theirproperties.168 in minne­ sota, la rive condominiums was among the first rental properties in the state to vote to make the building smoke-free. 169 the smoke-free policy for this par­ ticular rental property applies to individual units, common areas, garages, and private balconies.170 although current owners who smoke in their units are "grandfathered in," future buyers have to comply with the regulation.171 fur­ thermore, city councils in calabasas and belmont, california have passed or­ dinances that ban smoking in all apartments and condos located within the city limits.172 the calabasas ordinance, which requires 800...1. of apartments and condos to be permanently smoke-free by 2012, exempts current residents :from the smoking ban until they move.173 the belmont ordinance, which declares shs a "public nuisance,"174 makes residents who smoke subject to fmes and evictions if they do not cease smoking upon complaint by their neighbors.175 the belmont ordinance went into effect in january 2009, allowing current resi­ dents who smoke to vacate the premises without violating their lease.176 the push to make rental properties and residential units smoke-free has been met with its fair share of opposition;177 however, a majority of courts have sided with non-smoker residents, ruling shs a "nuisance."178 a study con­ ducted by the center for energy and the environment in st. paul, minnesota, found that as much as half of the air in a residential unit of an apartment build­ ing or condo comes :from other units.179 thus, it is fair to say that resident smokers not only expose non-smoker neighbors to the smell of smoke, but they also expose non-smoker neighbors to the harmful effects of shs. due to the close proximity of the living structure of rental properties and multi-unit hous167. koch 1, supra note 163. 168. /d. (noting that landlords in maine have received few complaints about their smokefree policies in rental units). 169. buchta, supra note 163. 170. /d. 171. id 172. nbcll, it's official-belmont bans smoking in some homes (oct. 10, 2007), http://www.nbc11.com/news/14307719/detail.html; joann grof:i: calabasas gives final okay to apartment smoking ban, the acorn, jan. 24, 2008, http:llwww.tbeacom.com/news/2008/ 0124/community/006.html; see also wendy koch, two california cities to vote on banning smoking in apartments, usa today, oct. 3, 2007, at la, available at http://www.usatoday. com/printedition/news/20071 003/1a _ bottomstrip03.art.htm [hereinafter koch 2]. 173. grof:i: supra note 172. 174. nbc11,supranote 172. 175. koch 2, supra note 172. 176. nbcll,supranote 172. 177. koch 1, supra note 163. since 1991, approximately twenty-seven lawsuits have been filed over smoking in apartments and condos. id 178. id 179. buchta, supra note 163. 2009] kicking the burr of secondhand smoke 315 ing, shs that drifts into neighboring apartments or condos is at the very least a nuisance. 180 because shs also poses a health risk, it is likely that more rental properties will take the necessary steps to eliminate shs exposure. jim berg­ man, director of the smoke-free environments law project, said "smoke-free housing is a win-win for the rental industry, because landlords can reduce fire risks and cleaning costs while pleasing the approximately 80% of american adults who don't smoke."181 therefore, if the "private" home is already being regulated to protect non-smoker residents from the nuisance of shs, then it seems reasonable to regulate the "private" vehicle to protect children. 2. not protecting against shs may be a violation of the covenant of quiet enjoymenl82 and/or the implied warranty of habitability183 -landlord/tenant cases some courts have gone a step further and considered shs as more than a nuisance, ruling that landlords could be violating their statutory obligations to tenants if non-smoker residents are exposed to shs. for example, in the case of dworkin v. paley, 184 a non-smoker tenant sought to terminate his lease and recover his security deposit after shs exposure from a unit below him caused him physical discomfort on a continuous basis. 185 in his complaint, the tenant alleged that by allowing him to be exposed to shs after repeated protests, his landlord violated the covenant of quiet enjoyment and other duties owed to him.186 although the landlord filed a motion for summary judgment187 and claimed that she never guaranteed that the building would be smoke-free, the ohio court held that a genuine issue of material fact existed because "reasona­ ble minds could come to different conclusions concerning whether the condi­ tion of ... the rental unit, i.e., the smoke, was sufficient to constitute a breach of the covenant of quiet enjoyment or a breach of any ofthe landlord's duties .. • • " 188 thus, the ohio court left open the possibility that a landlord, who does not guarantee a smoke-free building, could be in violation ofhis or her landlord 180. koch 1, supra note 163; buchta, supra note 163. 181. id 182. the covenant of quiet enjoyment is breached when the landlord "obstruct[s], inter­ fere[s] with, or take[s) away from the ... [tenant] in a substantial degree the beneficial use ... of the leasehold." dworkin v. paley, 93 ohio app. 3d 383, 386 (ohio ct. app. 1994). 183. the implied warranty of habitability "provide[s] modern urban dwellers with much needed protections and rights to compel landlords to make necessary repairs and essential ser­ vices." poyck v. bryant, 820 n.y.s.2d 774, 776 (n.y. civ. ct. 2006). within the implied war­ ranty of habitability is the expectation that "tenants are not subjected to any conditions endangering or detrimental to their life, health or safety." /d. at 701. 184. 93 ohio app. 3d. 383. 185. id. at 385. 186. id. 187. summary judgment is granted if"there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." !d. at 386. 188. id. at 388. 316 indiana health law review [vol. 6:291 duties if non-smoker tenants are exposed to shs from other tenants. similarly, in the case of poyck v. bryant, the new york civil court was asked to decide if shs from a smoker tenant "gives rise to a breach of the im­ plied warranty of habitability and a constructive eviction189 under the realities of modem urban dwelling."190 in this particular case, a landlord brought an action to collect rent and late fees from two tenants.191 the tenants, however, denied the allegations in the complaint and countered by asserting a breach of the warranty of habitability and constructive eviction because the landlord did not take any actions to prevent the shs from another tenant that incessantly drifted into the non-smoker tenants' unit192 the court stated that "[t]here is a duty to protect each other's right to privacy and a responsibility not to invade a neighbor's privacy. the unwanted invasion of privacy comes in many guises such as noise, smells, odors, fumes, dust, water and even secondhand smoke."193 the court held that because shs is a condition that invokes the pro­ tections of the warranty of habitability and other landlord duties, there were triable issues of fact that warranted a denial of summary judgment for the lan­ dlord.194 thus, if the landlord fails to protect non-smoker tenants from shs exposure, it appears that landlords can be held responsible for the actions of their third-party tenants under the implied warranty of habitability d. a minor restrained in a snwky vehicle is like a prisoner confined to a cell-a parallel to smt:jking bans in prisons motivated by the health risks posed by shs, many jails and prisons across the united states have restricted or banned smoking within their facilities.195 under these smoke-free policies, confined prisoners are not forced to breathe shs from other prisoners who smoke within the facility. 196 as of 2002, ap­ proximately thirty-eight state correctional departments reported total bans or at least partial bans on smoking in their facilities, 197 and by 2006 there were only twenty-one states that had not completely banned smoking on prison proper­ ty.198 the federal bureau of prisons has also enacted a near total ban on smoking inside its prisons.199 · 189. constructiveevictionis"[a) landlord'sactofmakingpremisesunfitforoccupancy, often with the result that the tenant is compelled to leave." black's law dictionary (8th ed. 2004). 190. poyck, 820 n.y.s.2d at 776. 191. ld. at 777. 192. ld 193. ld. at 776. 194. ld. at 780. 195. gregg zoroya, smoking bans spread to prisons, usa today, july 21, 2004, available at http://www.usatoday.com/news/nation/2004-07-21-prison-smoking-usat_x.htm.. 196. in re julie anne, 780 n.e.2d at 654. 197. zoroya, supra note 195. 198. ld 199. see wilcox, supra note 41, at 2090. 2009] kicking the butt of secondhand smoke 317 the supreme court has even ruled that a prisoner involuntarily subjected to shs in his cell may have a claim for cruel and unusual punishment under the eighth amendmenr00 because of the health risks associated with shs.201 in the case of helling v. mckinney, a prisoner brought an action alleging a viola­ tion of the eighth amendment after he was placed in a cell with a heavy smok­ er and repeatedly exposed to shs.202 the supreme court reasoned: [w]hen the state takes a person into its custody and holds him there against his will, the constitution impos­ es upon it a corresponding duty to assume some respon­ sibility for his safety and general well being . . . the rationale for this principle is simple enough: when the state by the affirmative exercise of its power so restrains an individual's liberty that it renders him unable to care for himself, and at the same time fails to provide for his basic human needs-e.g., food, clothing, shelter, medi­ cal care, and reasonable safety-it transgresses the subs­ tantive limits on state action set by the eighth amendment .... 203 the court further found that basic decency also demands that prisoners should not be subjected to unreasonable health risks caused by shs.204 the court stated that, "deliberate indifference to serious medical needs of prisoners vi­ olates the [eighth] amendment because it constitutes the unnecessary and wan­ ton infliction of pain contrary to contemporary standards of decency.'.zos by not protecting children from the harmful effects ofshs, a state's inaction is equiv­ alent to the "deliberate indifference" that the court in helling found would constitute cruel and unusual punishment. prisoners and children in vehicles are in a similar, unique situation be­ cause both are exposed to shs in confined spaces with high concentrations of shs. a prisoner, in his or her living quarters, is confined to a cell that is typi200. under the eighth amendment, prisoners are not to be subjected to cruel and unusual punishment. i d. at 2087. 201. helling v. mckinney, 509 u.s. 25,35 (1993);seealvoln rejulieanne, 780n.e.2d at 654 (citing seena k foster, annotation, validity, construction, and application of restric­ tions on use or possession of tobacco products in correctional facilities 66 a.l.r. fed. 5th 237 (1999) (prisoners cannot be involwltary exposed to shs because it is detrimental to their health)). 202. helling, 509 u.s. at 25. 203. ld. at 32 (quoting deshaney v. winnebago county dep't of social servs., 489 u.s. 189, 199-200 (1989)). 204. jd 205. i d. (quoting estelle v. gamble, 429 u.s. 97, 103-104 ( 1976); see also wilcox, supra note 41, at 2088 (although prisoners do not have a right to live in "comfortable prisons," the eighth amendment guarantees "a minimal civilized measure of life's necessities") (quoting rhodes v. chapman, 452 u.s. 337, 349 (1981)). 318 indiana healm law review [vol. 6:291 cally eight foot by eight foot in size. 206 while most people would agree that a jail or prison cell has very limited space, children, on the other hand, are re­ strained to an even smaller amount of space when they are inside a vehicle be­ cause of the lack of actual and open space. thus, like a prison cell, a vehicle magnifies the potential risks from shs. because prisoners and children in smoke-filled vehicles are restricted to such confined spaces, they are unable to seek refuge from shs exposure. 2(y1 additionally, the fact that prisoners and children are involuntarily exposed to shs in cells and vehicles offends notions of decency. if a nonsmoker goes to a bar or restaurant that does not maintain a smoke-free environment, they can choose whether or not to remain in that environment and be exposed to shs. unfortunately, prisoners and children do not have that luxury-their freedom to choose to leave a smoke-filled environment is limited or non-existent. prison­ ers who are exposed to shs cannot simply walk out of their cell to avoid poten­ tial harm-they instead, gave up those rights on the day they were convicted and sentenced to jail or prison. similarly, children have very little choice in whether or not they are exposed to shs in vehicles. younger children are ei­ ther unable to vocalize their complaints or are unaware of the harmful effects of shs. older children may not be aware of the effects ofshs and also may wor­ ry that if they speak up and object to smoking in the vehicle, they will "get in trouble" or upset the person who is smoking. prisoners have been deemed worthy of the most basic standards of decen­ cy, so why then, are children, who are one of the most, if not the most, defense­ less class of individuals, being overlooked? moreover, if a majority of prisoners are not forced to breathe shs in a confined space and are protected from the dangers of shs, then why are children not afforded that same protec­ tion? furthermore, when children are restrained in smoky vehicles, they are themselves prisoners/captives in the vehicle, but the only thing children are guilty of is being of a vulnerable age that has no, or very limited, choice about whether to be exposed to shs. thus, if prisoners are shielded from shs, then children definitely should not be forced to breathe shs in a confined space like the vehicle. 206. wikianswers.corn, what is the average size of a us prison cell?, http://wiki.answers.com/q/what_is_the_average_size_o(..a_us_prison_cell(lastvisitedsept 30,2008). 207. see wilcox, supra note 41, at 2085 (prisoners cannot escape breathing air that has been contaminated with shs) (citing lisa gizzi, helling v. mckinney and smoking in the cell block: cruel and unusual punishment?, 43 am. u.l. rev. 1091, 1129 (1994)). 2009] kicking tile burr of secondhand smoke 319 iv. it is time for indiana to take action: indiana needs to pass a smoking ban on veidcles carrying minors a. smoking & indiana: the startling statistics tobacco plays a big role in the state oflndiana. considering that the state ranks ninth in tobacco production,208 it is not surprising that indiana has the second highest rate of smoking amongst adults. 209 not only do almost 27% of adults in indiana smoke cigarettes, but approximately 9,700 adults in indiana die each year from smoking. 210 logically, this places a large financial burden on the state. each year, medical costs in indiana attributable to smoking reach almost $2 billion.211 in addition, "[t]or every pack of cigarettes sold in indiana, hoosiers spend $7.10 in health care costs related to smoking. "212 consequently, with the alarming number of smokers in indiana, shs has a big impact on the state. it is estimated that every year between 1,020 and 1,820 nonsmokers, including children, die from shs in indiana. 213 further­ more, approximately 420,000 children are exposed to shs in their indiana homes. 214 the appropriate inference is that the same amount of children, if not more, are exposed to shs in vehicles. clearly, shs is a very real problem for indiana. children in indiana are being adversely affected by shs and remain an "exposed" population because the state has not yet enacted any bans that protect children from shs, other than in the child or foster care setting.215 be­ cause of the pervasiveness ofshs, it is time for indiana to step up to the plate and enact a smoking ban on vehicles carrying minors. b. common sense legislation: a proposed plan for indiana 1. a step in the right direction: the ban that almost was because indiana is a key player in tobacco production,216 one would think that the chances are slim that indiana will ever pass a smoking ban on vehicles. 208. ljnited states department of aoriculrure, nationalagricul1ure statistics service, indiana fmid office (2004), http://www.in.gov/dwd/files/ indiana_ crop_production_ pg2. pdf (last visited sept. 30, 2008). 209. indiana tobacco prevention and cessation, indiana's tobacco burden (july 10, 2006), http://www.in.gov/itpc/fileslresearch_87.pdf(last visited sept. 30, 2008). 210. /d. 211. /d. 212. id 213. campaign for tobacco-free kids, the toll of tobacco in indiana (2005), http://tobaccofreekids.org/reportslsettlementsltol.php?stateid=in. 214. /d. 215. see ind. code§ 16-41-37-1 et seq. (2003). 216. see supra note 208 and accompanying text. 320 indiana health law review [vol. 6:291 however, state representative charlie brown (d-in)217 transformed a slim possibility into a real possibility when he authored and introduced legislation in 2007 that addressed smoking in vehicles carrying children.218 at the sugges­ tion of some constituents in his district, 219 representative brown introduced house bil11337, which proposed to ban smoking in vehicles when children under the age ofthirteen220 are present 221 violators of the proposed ban would be subject to a $25 fine for the first offense and $100 fine for subsequent viola­ tions. 222 the ban made smoking in vehicles with children present a secondary offense. 223 according to representative brown, he was urged to author this type of legislation because his constituents are tired of seeing adults smoke in their vehicles while children are present 2z4 at the time he introduced the pro­ posed ban, representative brown was unaware that arkansas and louisiana had already passed such legislation.225 although the proposed bill received positive feedback and passed the first and second readings before the committee on the judiciary,226 it was ultimately defeated at the third reading, 227 where it did not receive the required number of votes to continue in the process to become new legislation.228 further, an al217. representative brown, who lives in gary, indiana, was elected to the indiana house ofrepresentatives for the third district in 1982. indiana general assembly; indiana state rep­ resentativecharliebrown(2008),http://www.in.govllegislativelhouse_democratslbrown_bio­ graphy.html. representative brown, chairman of the indiana house standing committee on public health, played a key role in 2007 in "enacting a new statewide effort to promote im­ proved health care for hoosiers." jd further, representative brown helped establish a proac­ tive statewide smoking cessation/prevention program in indiana. id 218. h.b. 1337, 114th gen. assem., reg. sess. (ind. 2007). 219. telephone interview with representative charlie brown, indiana state representa­ tive, in indianapolis, ind. (feb. 7, 2008). 220. jd. (according to representative brown, he decided to draw the line at age thirteen because of the issue of "choice." he stated that it is more likely that the younger children are unable to be left at home by themselves or with a babysitter, and instead will have to travel with the adult in the vehicle. representative brown further stated that younger children have no other choice in the matter, but children aged thirteen and older have more of a choice as to whether they ride in a vehicle with a smoker or stay home.) 221. h.b. 1337, 114th gen. assem., reg. sess. (lnd 2007). 222. jd. 223. jd. 224. telephone interview with representative charlie brown, supra note 219. 225. jd 226. jd 227. 3rd reading on hb 337, smoking in a vehicle with children, before the h., 115th gen. assem., reg. sess. (feb. 21, 2007) (defeated 51 to 43), available at http://www.in.gov/ legislativelbills/2007/pdf/hrollcal/0 l88.pdf.pdt: 228. telephone interview with representative charlie brown, supra note 219; see also indiana general assembly, state house tour office-how a bill becomes a law (2001), http://www.in.gov/idoa/files/billintolaw.pdt: in order for a bill to become a law in indiana, it must complete these (over-simplified) steps: l) a bill is drafted and introduced; 2) a bill has its first reading where it originated; 3) a bill is assigned to a committee and the committee takes action on it; 4) a bill is sent back for a second reading; 5) the house of origin holds a third read­ ing and the bill is voted on; 6) the process repeats in the other chamber; 7) the bill returns to the house of origin; 8) the bill is assigned to a conference committee; 9) the bill is sent to the gov­ ernor; 10) the bill {assuming it has survived all of the other steps) becomes law. id 2009] kicking tile burr of secondhand smoke 321 most identical bill was introduced on january 8, 2008, but it was withdrawn on january 14,2008.229 as chairman of the public health committee and a per­ son who is admittedly very interested in the issue of shs, representative brown was "shocked and disappointed" when his proposed bill did not pass.230 representative brown recognizes the hannfu1 effects that shs has on children and emphasizes the fact that children are defenseless when it comes to shs exposure and have no means to avoid it.231 further, representative brown thinks that adults should be more responsible in this arena because children's health costs associated with shs exposure are ultimately coming out of tax dol­ lars. 232 although some of his colleagues argue that this type oflegislation is too intrusive into private lives, representative brown points out that the govern­ ment already sets policy for almost every facet oflife and that this area should be no different, especially when it is an issue concerning the welfare of child­ ren.233 further, representative brown stated, "[i]fwe can justify [telling par­ ents] that their kids have to go to school until age sixteen, we can require that parents not smoke in vehicles. •.234 representative brown has brought the state one step closer to passing a ban on smoking in vehicles carrying children. not only has representative brown spread the word and gained support in favor of these types ofbans, but he has also provided the state of indiana hope that it can one day pass a smok­ ing ban on vehicles. although representative brown acknowledges the major role tobacco plays in the state, he indicated that he thinks it is very likely that indiana will pass this type of ban in the future.235 further, representative brown intends to introduce his bill again in upcoming legislative sessions. 236 2. where does indiana go from here? although representative brown has taken the initiative to introduce legis­ lation that would eliminate.children's exposure to shs in vehicles,237 indiana has not enacted such a ban and as a result, the children of indiana remain ex­ posed to the dangers ofshs. clearly, there is substantial evidence surrounding shs and its effects on children.238 indiana must act now to protect children from the risks posed by shs exposure. with so many adult smokers in indiana, . 229. h.b. 1056, i 15th gen. assem., reg. sess. (ind. 2008). this bill proposed to ban smoking in vehicles carrying children under thirteen years of age. /d. violators would be sub­ ject to a $25 fine for a first offense and a $100 fine for subsequent violations . . jd 230. telephone interview with representative charlie brown, supra note 210. 231. jd 232. /d. 233. id. 234. id 235. jd 236. telephone interview with representative charlie brown, supra note 210. 237. see supra notes 220-223, 225 and accompanying text. 238. see supra part id.l. and accompanying text 322 indiana heal til law review [vol. 6:291 hoosiers should be especially concerned about shs and its potential impact on the state and the state's children. the only way to ensure that children can breathe fresh air free from shs is to regulate the areas in which children are still being exposed. thus, indiana needs to pass a smoking ban on vehicles canying minors. as seen through the practice of other states, it is possible and very reason­ able to enact a smoking ban on vehicles canying minors.239 · although bans in arkansas, california, and louisiana vary in their age restrictions, application, and penalties resulting from the bans, the primary focus remains the same: the children. 240 arguably, as long as a state enforces a smoking ban that protects some age group within the class "children," this is better than the alternative of no regulation. however, indiana needs to go beyond protecting a limited group of children (i.e. six year olds and younger) and instead have a smoking ban on vehicles that protects all minors. thus, indiana should prohibit smoking in ve­ hicles when children aged seventeen and younger are present. while it is true that the older a child gets, the more choice and free-will they develop, what "choice" they have may still be limited in some shape or form. further, people are not allowed to purchase cigarettes until the age of eighteen241-an age where people are considered to be adults. if the state has determined that child­ ren are not old enough to purchase cigarettes until the age of eighteen, then it is reasonable for indiana to decide that that same class should be protected from shs in vehicles. unlike california's smoking ban on vehicles canying minors that classi­ fies violations as secondary offenses, 242 indiana's ban should classify violations of the ban as primary offenses. because shs and its effects on children are a serious matter, the state needs to treat violations of the law as a serious matter. further, indiana needs to make it apparent that it does not condone involuntary exposure to shs, which would be accomplished by giving the police the au­ thority to make a traffic stop for no other reason than witnessing an adult smok­ ing in a vehicle with a minor present. moreover, it can be just as easily enforced as pulling someone over for not wearing a seatbelt.243 additionally, those who violate indiana's smoking ban should be subject to more than just a slap on the wrist. a $25 fine for a first time offense is not going to get the point across to a violator that he or she should take the law se­ riously. at a minimum, violators of indiana's ban should be faced with a fine of $100, and subsequent violations should result in increased fines. further, indiana should also consider sentencing violators of the smoking ban to com­ munity service in addition to or in lieu of a fine. unquestionably, children need to be protected from shs, especially when 239. see supra part ll.a-b and accompanying text. 240. ld 241. see ind. code§ 35-46-1-10.5 (1997). 242. see supra note 94 and accompanying text 243. see supra part ill.b and accompanying text. 2009] kicking the burr of secondhand smoke 323 it comes to a confined space such as the vehicle. indiana has within its grasp a means to make it happen-a smoking ban on vehicles carrying minors. it is time that indiana acknowledges the dangers ofshs and the effects ofshs on children by passing legislation that addresses and confronts the issue. with all of the research and data that has conclusively found that shs poses a serious risk for children, it would be absurd for indiana not to pass this type oflegisla­ tion. the children of indiana are worth it v. conclusion there are no ifs, ands, or butts about it--shs is not safe at any level, in any form, or for any length of time. further, shs is particularly harmful to children who are still in the process of growing and developing. although there has been an increase in smoking bans over the past few years, children are still exposed to shs in their homes and in vehicles. when children are re­ strained in smoky vehicles, they breathe in toxins and carcinogens that are typi­ cally found in shs, but at a more concentrated level. the only way to address this issue and to protect children from the damaging effects of shs is to regu­ late the private vehicle and prohibit smoking in the vehicle when children are present. although opponents argue that these smoking bans violate their privacy rights, there is no fundamental right to smoke. in balancing the health and in­ terests of children with the interests of smokers, the children's rights over­ whelmingly outweigh the rights of smokers. common sense dictates that children-voiceless, defenseless, innocent children-warrant protection. states need to step in and protect children from something that has been proven to be extremely harmful. in addition to common sense, states have a duty to protect children. adults can choose whether or not to smoke. nonsmoker adults can choose whether or not to be around shs. children, on the other hand, cannot choose and should not be penalized nor have their health jeopardized simply because they are too young to defend themselves or know better than to ride in the same vehicle as a smoker. states are not forcing prisoners to breathe shs in a confined space. likewise, children should also not be compelled to breathe shs in the confined space of a vehicle. because three states (arkansas, california, and louisiana) have success­ fully passed legislation addressing smoking in vehicles carrying minors, 244 it is possible for other states to do so as well. specifically, indiana, a state known for tobacco production and with a large number of adult smokers, 24s needs to join the fight against shs and prohibit smoking in vehicles carrying minors. by protecting children from potential health problems associated with shs, a ban like this just makes sense. 244. see supra part ll.a-b and accompanying text. 245. see supra note 208-210. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i move over managed carehealth savings accounts, small businesses, and low wage earners: cost, quality, and access russell b. cate • table of contents i. introduction .•..•.•••.•.•.........•....•••..•..••••......•.•..•......••...••.•.......•..••• 287 n. background on hsas ••....•••..••.••.•.••.••.....••....••••..•••••.•..••.........•... 290 a. the departure from managed care ....................................... 290 b. health savings accounts .......................................................... 294 ill. can hsas successfully achieve cost reduction and universal care? ................................................................. 297 a. cost reduction ......................................................................... 298 b. access to health care goods and services .............................. 303 n. small businesses and the uninsured: struggles with hsas .............................................................................................. 307 v. promising alternative solutions to the high costs of health care ................................................................................. 310 a. consumer education ................................................................ 311 b. organized consumer bargaining factions ............................. 312 c. health security for all americans act ..................................... 313 d. association health plans (small business health plans) ........ 315 vi. conclusion ................................................................................... 317 i. introduction the high cost ofhealth care in the world's most prosperous nation is be­ coming an increasingly pervasive problem. rather than making cost contain­ ment and access a function of the government, congress continues to search for solutions with a capitalistic approach. in other words, congress continues to leave the task of decreasing health care costs to the marketplace.1 • j.d., 2007, indiana university school oflaw, indianapolis, indiana; ba., 2000, pur­ due university, west lafayette, indiana. i sincerely wish to thank professor andre hampton of the school oflaw at st. mary's university, san antonio, texas, whose comments and sugges­ tions provided guidance and encouragement for the completion of this note. i would also like to thank my wife, jennifer, and my parents for their love, support, and encouragement. 1 andre hampton, markets, myths, and a man on the moon: aiding and abetting america's flight from health insurance, 52 rutgers l. rev. 987, 988 {2000) [hereinafter hap­ ton, america's flight from health insurance] {"the presumption that the government is waste­ ful and inefficient is central to the american credo. adherence to this belief yields a distinctly american mythology. . . [that] [ w]e cannot trust the government with too much power to allo288 indiana health law review [vol. 4:287 as some critics have suggested, however, the health care market differs markedly from other market forums, and thus the same principles that proved successful in the marketplace cannot be successfully applied in the health care context.2 on the other hand, advocates of the market solution have hailed the medicare prescription drug, improvement, and modernization act of20033 ("mma"), which created health savings accounts ("hsas"), as a potential reso­ lution to the cost containment problems facing the health care industry. because they are still in their infancy, little has been written about the ef­ fect hsas have had on the current health care crisis facing america. a basic review of the goals and functions behind hsas may help to conceptualize how hsas are impacting the cost, quality, and access problems commonly associ­ ated with the health care industry. generally, "[hsas] are a new way [to] pay for medical expenses not covered by insurance or other reimbursements.'>'~ hsas were created to achieve three primary goals: 1) to promote savings for health related expenses, 2) to encourage prudent health care spending by pro­ viding incentives to consumers, and 3) to provide consumers with the ability to select and fund their own health care services. 5 when put into practice, how­ ever, hsas may be less effective for certain economic brackets of society, such as small business owners and their employees who often may find themselves lower on the socio-economic ladder. the inclusion ofhsas in the mma is another piecemeal attempt by con­ gress to resolve cost containment and access issues without implementing wholesale government intervention to help america finance health care. hsas are being utilized to avoid the problems associated with managed care that led the market to leave the managed care model and gravitate toward the consumer driven model. the problems with managed care include the following: the in­ ability to control costs,6 the amount of responsibility borne by the consumer, 7 fmancial risk sharing, 8 and market failure within the health care industry.9 hsas were designed to alleviate these problems by placing the consumer in control of his/her own finances, thus, ideally forcing him/her to become more cate resources because the government ... will squander [them]."). 2 id. at 994 95. 3 medicare prescription drug, improvement, and modernization act of2003, pub. l. no. i 08-173, 117 stat. 2066 (codified as amended in scattered sections of 42 u.s. c. and 26 u.s. c.). 4 bob lyke, chris peterson & neela ranade, cong. research serv., health savings accounts 2 (2005), available at http://www.law.umaryland.edu/marshall/ crsreports/crsdocuments!rl3246701212005.pdf. 5 jd. 6 andre hampton, the princess and the pea: the assurance ofvoluntary compliance between the texas attorney general and aetna's texas hmos and its impact on financial risk shifting by managed care, 83 b.u. l. rev. 553, 588 (2003). 7 id. 8 andre hampton, resurrection of the prohibition on the corporate practice of medicine: teaching old dogma new tricks, 66 u. cin. l. rev. 489, 505-06 (1998). 9 hampton, america 's flight from health insurance, supra note 1, at 996. 2007] hsas and small business: cost, quauiy, and access 289 prudent consumers of health care services.10 inherent in the success ofhsas, however, is the assumption that consumers will have available to them the in­ formation necessary to make educated decisions about their health care expen­ ditures.11 on the contrary, health care consumers generally do not have the informa­ tion they need to negotiate adequately with potential providers for the most cost efficient service. "bargaining power disparities are a real phenomenon that can affect the ability of the 'weak' party to obtain its preferred terms in a contrac­ tual interaction with a 'strong' party."12 this "phenomenon" has implications in the health care realm because there, consumers and small business employees are the ''weak" parties as they do not have access to the necessary information needed to negotiate with the "stronger'' health care and service providers de­ manding payment. the resulting contractual terms tend to favor the health care providers and leave consumers bearing the brunt of health care costs when the federal government is in the best position to assist consumers with excessive health care related expenditures.13 this may be especially true for small busi­ ness owners who may want to offer health plans for their employees but wish to avoid the high costs associated with offering these plans. hsas provide an al­ ternative to expensive and burdensome health plans, but unfortunately, hsa implementation in the small business context is not likely to succeed because small business employees will not be able to finance the high deductibles asso­ ciated with hsas. 14 another problem, which often is overlooked, centers on the difficulty low income individuals face when in need of medical care. this segment often con­ sists of small business employees who make too little to afford out of pocket expenses yet generate enough income that disqualifies them from medicare. 10 john v. jacobi, government reinsurance programs and consumer-driven care, 53 buff. l. rev. 537, 558 (2005) [hereinafter jacobi, government reinsurance] (proposing the government implement a broad reinsurance program to bear most of private coverage's catastro­ phic costs). 11 john v. jacobi, consumer directed health care and the chronically ill, 38 u. mich. j.l.reform 531,556-57 (2005) [hereinafter jacobi, consumer directed health care] (describ­ ing the recent development in consumer-controlled spending accounts and suggesting regulatory changes that places catastrophic and chronic health care costs on the government). 12 daniel d. bamhizer,inequality of bargaining power, 76 u. colo. l. rev. 139, 150 (2005). professor bamhizer distinguishes the legal concept of unequal bargaining power from the practical concept ofbargaining power. for purposes of this note, only the practical concept of bargaining power will be considered. 13 jacobi, government reinsurance, supra note 10. see also jacobi, consumer directed health care, supra note 11; hampton, america's flight from health insurance, supra note 1, at 996 (suggesting that the health care market is an inefficient market unable to allocate appro­ priately and that government intervention is necessary to remedy the inefficiency). 14 brian headd, the characteristics ofsmall business employees, montiilylab. rev., apr. 2000, at 13, 15-16, available at http://stats.bls.gov/opub/mlr/2000/04/art3full.pdf. the article stated that fifty-two and two tenths percent of small firm employees had less than a high school diploma, and in 1998 small firms were responsible for employing more employees re­ quiring government financial assistance than large firms did id. 290 indiana health law review [vol. 4:287 ironically, the high cost of goods and services necessary to facilitate quality health care are the same goods and services that are una:ffordable for americans lacking coverage. the united states census bureau reports· that in 2004, roughly 45.8 million, or fifteen percent, of americans lacked health insurance coverage. 15 small business employees without health coverage can quickly spend what little financial resources they have on necessary medical expenses. the committee on education and labor estimates that sixty percent of workers who are uninsured work for a small firm. 16 thus, the lack of available health coverage forcibly drives the low income small business employee farther and farther into debt and poverty. this reality helps to bolster the argument against hsas because any market based solution to health care cost and access prob­ lems will inevitably leave many without coverage.17 supply and demand of market forces should not be allowed to deprive consumers of quality health ser­ vices. this note will briefly discuss the market trend heading toward consumer driven health care and away from managed care. in particular, this note will review how hsas can resolve problems of available health insurance to small business employees. next, this note will consider the importance of maintain­ ing the dualistic function ofhsas in light of the unequal bargaining power pre­ sent among small businesses and their employees when compared to the rest of the health care insurance market. this note will also discuss the difficulties hsas present for these segments of the population. finally, this note will con­ sider several proposed solutions to the problems created by the implementation ofhsas. u. background on hsas a. the departure from managed care to better conceptualize this recent shift toward consumer driven health care ("cdhc") it is necessary to gain a basic understanding of its roots. cdhc was essentially an outgrowth of managed care.18 '"[m]anaged care,' [is] a variety of organizational arrangements for providing and financing medi­ cal care in which the financing entity plays an active role in monitoring and is u.s. census bureau, hea.ltij insurance coverage 2004 (2005), available at http://www.census.gov/hhes/wwwlhlthinslhlthin04/hlth04asc.html. these numbers reflect an increase of800,000 united states citizens since 2003. 16 press release, u.s. house ofrep., comm. on edu. & labor, small business health plans: providing affordable health insurance to uninsured working families, promoting small businesses (jan. 5, 2007) [hereinafter small business health plans], available at http://~licans.edlabor.house.gov/prarticle.aspx?newsid=9&iid=13. 1 hampton, america's flight from health insurance, supra note 1, at 1001. 18 john v. jacobi, after managed care: gray boxes, tiers, and consumerism, 41st. louts u. l.j. 397, 404 (2003) (stating that cost, control, and access are problems that were ini­ tially remedied by managed care during the mid-late i 990s, but the problem has returned and new solutions need to be implemented). 2007] hsas and small business: cost, quality, and access 291 controlling the amount and types of services that physicians provide to pa­ tients."19 in other words, managed care was designed to streamline the insur­ ance and health care functions into one organization. 20 prior to managed care, americans utilized a fee-for-service system that allowed greater flexibility for americans to choose their health care providers. 21 the downside was that fee­ for-service plans required health care related expenses to be paid upfront; reim­ bursement for these expenses was obtained by submitting receipts to the em­ ployer.22 this placed an enormous responsibility on patients' shoulders. the managed care structure began to escalate in popularity during the 1970s and 1980s. during this period, rapidly increasing health care costs, widespread support for the deregulation ofhealth care, and a strong reliance on market forces helped contribute to managed care's popularity.23 employers who chose to use the managed care model rather than the fee-for-service model began to realize a new method of cost containment. under the managed care model, health care options were either limited to using either "preferred provid­ ers" or enrollment in a health maintenance organization ("hmo") which re­ quired them to utilize any physician employed by the hm0.24 although the scope of care was limited to providers selected by the employer or hmo, em­ ployees under the managed care model benefited from lower insurance premi­ ums and nominal co-payments.25 although fee-for-service programs allowed for a variety of choices in health care providers, these programs did little to control the high cost ofhealth care. managed care offered a variety of cost containment practices such as "aggressive utilization managemenr6 to capitated funding arrangements, limita19 russell korobkin, the efficiency of managed care "patient protection" laws: in­ complete contracts, bounded rationality, and market failure, 85 cor.nelll. rev. 1, 5 (1999). 20 alice a. noble & troyen a. brennan, the stages of managed care regulation: de­ veloping better rules, 24 j. health pol. pol'y & l. 1275, 1277 (1999). 21 ronald weich, managed care and managed sentencinga tale of two systems, 2 fed. sent'g rep. 139 (1998). 22 id. 23 noble & brennan, supra note 20, at 1277. 24 weich, supra note 21. see generally matthew j. binette, patients' bill of rights: legislative cure-all or prescription for disaster?, 81 n.c. l. rev. 653,666 (2003) (discussing the increased enrollment of employees in managed care plans following the adoption of the hmo act and erisa). 25 weich, supra note 21. 26 jeffrey e. shuren, legal accountability for utilization review in erisa health plans, 77 n.c. l. rev. 731, 740 ( 1999) (explaining that utilization management is part of the unique­ ness behind hmos and that utilization review is an objective process to determine whether an individual's medical expenses should be covered or not). a large part of criticism surrounding managed care has involved utilization management and the inability to sue an hmo due to erisa preemption. "erisa limits available remedies and precludes the award of compensa­ tory and punitive damages." /d. there have been a number of cases decided by the united states supreme court that have centered on this debate. e.g. aetna health inc. v. davila, 542 u.s. 200 (2004) (explaining how plaintiffs brought suit under texas state law against their re­ spective hmos for failure to exercise ordinary care in their coverage decisions. the court held 292 indiana health law review [vol. 4:287 tions on choice of providers, limitations on benefits, exclusive contracting ar­ rangements, and other financial incentives such as bonuses and withholds" in order to help reduce the rapidly increasing cost ofhealth care. 27 the early suc­ cess of managed care as a cost containment strategy was initially hailed as the solution to maintaining health care costs. as technology in health care began to escalate, however, the costs associated with that care began to rise and notice­ able problems with the system began to emerge. among the myriad of problems attributed to the failure of managed care,28 two in particular should be discussed because they correlate directly with health care cost inflation. first, over time health care consumers had become passive in their consumption of health care goods and services.29 in effect, consumers were over-utilizing the health care industry for minor health ailments, such as the common cold or a minor sinus infection, which normally require no medical attention. 30 as a result, consumers had little concern for the burdens they were placing on the health care providers because these patients "were fully insulated from costs and had no responsibility for managing care."31 in response, man­ aged care providers attempted to reduce costs by limiting treatment to instances that were medically necessary. 32 one critic argued that this approach conflicted with what he called "judge made insurance," which is a term used to describe the judicial tendency to interpret contracts based upon what a consumer should have reasonably expected rather than interpreting the contract by its plain lan­ guage or what the consumer actually expected. 33 in other words, when an indithat plaintiff's cause of action was "completely preempted and was removable to federal court."); pegram v. herdrich, 530 u.s. 211 (2000) (the court denied respondent's claim that when petitioners delayed treatment decisions to increase incentives, they breached a fiduciary duty. the court held that hmo physicians are not fiduciaries of the hmo and thus there is no federal claim arising under erisa). 27 peter d. jacobson, who killed managed care? a policy whodunit, 47 st. louis u. l.j. 365, 368 (2003). see also amyl. cralam, the serpent in the garden of eden: a look at the impact of physician financial incentive programs and a reconsideration of herdrich v. pegram, 16 j.l. & health 289, 308-18 (2002) (discussing various types of cost containment practices used by managed care organizations). 28 jacobson, supra note 27, at 390-92 (suggesting the managed care industry may be responsible for its own undoing). additional factors contributing to the decline of managed care include: poor implementation of the managed care concept, the propensity of the industry to avoid responsibility for its part in clinical decisions, a severe lack of information made available to the public, and the industry's concentration on public relations and failure to devote resources to advancing the quality ofhealth care. !d. 29 brian j. marcotte, how employers can make consumer-driven health care a real­ ity?, in consumer-driven health care: impucations for providers, payers, and poucy­ makers 213-23 (jossey-bass 2004). 30 see wendy k. mariner, can consumerchoice plans satisfy patients?, 69 brook. l. rev. 485,496 (2004) (discussing how consumer driven health plans help remedy this prob­ lem by placing the responsibility for medical treatment decision making directly on the con­ sumer). 31 marcotte, supra note 29, at 213-23. 32 jacobson, supra note 27. 33 e. iiaavi morreim, holding health care accountable: medical marketi'lace 45 (oxford univ. press 2001 ). law and the new 2007] hsas and small business: cost, quality, and access 293 vidual signs a contract for insurance coverage it is likely that they will not con­ sider all the implications of the terms contained in a particular agreement. as a result, they may be signing a document that provides for less coverage than ex­ pected. 34 thus, this judge made insurance is most noticeable in judicial opin­ ions involving payment and coverage that were favorable to patients seeking care that was not actually covered by their insurance contracts. unfortunately, the managed care industry was viewed as effectively discouraging patients :from utilizing health care services for minor ailments that had the potential of devel­ oping into more severe conditions. limitations on access to medical treatment lay the foundation for the second problem associated with managed care. the second set of problems associated with managed care involves the difficulty in establishing a provider's liability for negligence, :fraud, substandard care, or denial of benefits. this is an area where, beginning in the early 1990s, the federal government began to take a more active role in managed care regu­ lation.35 for example, the united states supreme court has ruled in several cases that a state cause of action against a managed care provider was pre­ empted by the employee retirement income security act of 1974.36 patients injured by a managed care provider's decision to deny benefits are only able to recover actual losses. 37 therefore, patients whose medical expenses are covered 34 ld. as dr. morreim pointed out, judges have a tendency to interpret contracts consis­ tent with the expectation of the consumer rather than interpreting the contract consistent with the terms of the agreement. in effect, the judicial system has assumed the responsibility of dic­ tating the terms of some insurance contracts. this may be attributed to a judge's propensity to interpret contracts consistent with the canon of construction that suggests contracts should be universally interpreted against the drafter, or it may be as simple as a particular judge's dislike of large insurance companies. either way, limiting treatment to what the insurance company deems is medically necessary may become impossible with practices such as 'judge made insur­ ance." 35 see brian biles & david sandman, ensuring equal access to care, in regulating managed care theory, practice, and furure options 135, 139 (stuart h. altman, uwe e. reinhardt, david shactman eds., 1999) (discussing policymakers' attempts to respond to con­ sumer concerns about access to health care in the managed care industry). see also binette, supra note 24 (analyzing the legislative steps some states have taken to promote patients' rights). 36 see, e.g., aetna health inc. v. davila, 542 u.s. 200 (2004); pegram v. herdrich, 530 u.s. 211 (2000). see also aarons. kesselheim & troyen a. brennan, the swinging pendu­ lum: the supreme court reverses course on erisa and managed care, 5 yale j. health pol'y l. & ennes 451 (2005); noble & brennan, supra note 20. but see larry j. pittman, a plain meaning interpretation of erisa 's preemption and savings clauses: in support of a state law preemption of section 1132(a) of erisa 's civil enforcement provisions, 41 san diego l. rev. 593 (2004) (suggesting that erisa's savings clause promotes federalism by de­ sign). 37 eric m. eusanio, control, quality, and cost: the need for federal legislation amending erisa 's failure to protect consumers from liobility-free mcos, 7 j.l. & pol'y 627, 646-47 (1999) ("although erisa's enforcement provisions provide judicial remedies to seek relief for breaches of contractual or fiduciary obligations, the statute has been interpreted as failing to provide a mechanism by which employee-consumers can seek redress for injuries caused by the direct negligence of their mcos.''). 294 indiana health law review [vol 4:287 by managed care providers have no adequate redress for errant treatment deci­ sions.38 this problem is compounded by the lack of information available to consumers necessary for them to make prudent decisions regarding their health care.39 managed care in its current form will not soon be entirely replaced by an­ other form of health care regulation. this does not, however, negate the need for an alternative means to regulate problems within the health care market. "[r ]ecent history has demonstrated [ ... ] managed care plans, even as modified in reaction to backlash, are not well suited to serve the goals of increasing ac­ cess, containing cost and assuring quality, absent a non-market public policy intervention.,.to thus, the final solution to cost and access problems does not end with the failure of managed care. rather, other health care financing alter­ natives seem to be rapidly gaining in popularity as a result of legislative and executive initiatives to alter the face of health care access. b. health savings accounts the movement away from managed care has been spearheaded by a movement toward consumer driven health plans ("cdhps").41 a relatively new concept, the premise for these cdhps was stated by one proponent as be­ ing "fundamentally about empowering health care consumersall of uswith control, choice, and information.'.42 furthermore, this"[ c ]onsumer control will reward innovative insurers and providers for creating higher-quality, lower-cost 38 in july of2005, a jury awarded nine million dollars to peter john smelik after he filed suit against humana health plan of texas, inc., among others, essentially for mismanaging ma­ naged care. as a practical matter, a cause of action for mismanaging managed care presents a new cause of action against hmos that is not preempted by federal erisa law. in re humana health plan of tex., inc., 2005 tex. app. lexis 5389. see physicians for a national health program, jury awards $7.4 million in wrongful death lawsuit against humana hmo (2005), available at http://www.pnhp.org/news/2005/july/jury_awards­ _74_ mil.php. see also ais managed care, healrn plan lawsuit watch (2005), available at http://www.aishealth.com!managedcare!hmolawsuitwatch!smelik _ v _ mann.html (explain­ ing that the case was actually settled before trial but texas law requires jurors to assign blame among defendants). 39 see infra text and notes accompanying parts iii.b, v.a. 40 jacobi, after managed care, supra note 18, at 409. see also melissa ganz, note, the medicare prescription drug, improvement, & modernization act of2003: are we playing the lottery with healthcare reform?, 2004 duke l. & tech. rev. 11 (2004) (suggesting that the current status of american health care is insufficient to address the needs of the population); jacobi, consumer directed health care, supra note 11, at 541-42 (suggesting that the move­ ment toward cdhps may likely have been the result of managed care's inability to accurately respond to a consumer market "that valued price, [either] because the structure of third-party health coverage created agency problems, because employees lacked appropriate information or the ability to use it, or because members lacked the ability to choose their plan."). 41 jacobi, consumer directed health care, supra note 11, at 536. 42 regina e. herzlinger, consumer-driven health care: implications for prov­ iders, payers, and policymakers xvii (jossey-bass 2004). 2007] hsas and small business: cost, quauiy, and access 295 services we want and deserve."43 thus, the success ofcdhps will depend on the consumer's ability to access and apply information obtained through a vari­ ety of mediums on the various benefits of each cdhp when. one is making health care consumption-related decisions. the consumer, however, has two essential decisions to consider when evaluating available information. first, consumers must decide how much of their financial resources will be attributed to their respective hsa. more than likely the consumer will make this decision when in good physical and mental health.44 as a result of underestimating the likelihood of a future need formed­ ical attention, there may be a tendency to underfund his or her account. con­ versely, the second decision may require a consumer to make a purchasing decision as a patient in need of medical attention rather than as a healthy con­ sumer. thus, the risk of under-funding can occur when consumers make nal've, irrational, or ill informed decisions regarding their hsas.45 the underlying problem is that consumers who are in good health may not rationally consider what type of funding is necessary for adequate future health care. conse­ quently, when health care becomes necessary, the hsa may be insufficient to cover health care costs. generally, a cdhp is a savings plan involving an account where one may deposit funds before taxes are paid and then utilize these funds for medical re­ lated expenses, tax free.46 several types ofcdhps exist, such as hsas, medi­ cal savings accounts, flexible spending accounts, and health reimbursement arrangements. 47 the most significant of these plans was· introduced when president george w. bush signed the medicare prescription drug, improve­ ment, and modernization act of2003 ("mma"). 48 this act introduced health savings accounts that allow participants to "accumulate funds for health care and other purposes. "49 the idea is that consumers would now spend more of their own funds to purchase health care goods and services, consequently, forc­ ing consumers to become more informed and prudent about their health care related spending decisions. hsas require that the individual seeking to open an account has health in43 !d. 44 jacobi, consumer directed health care, supra note 11, at 557. 45 arti k. rai, reflective choice in health care: using information technology to pre­ sent allocation options, 25 am. j.l. & men. 387, 393-94 n.57 (1999)(suggestingthat informa­ tion technology is essential to informing consumers about health care financing options.). 46 alden j. bianchi, options in consumerdriven health care: hsas, hras, and fsas, medicare reform, health savings accounts and the future of consumer directed health care, 64 a.l.i. 1061, 1063 (2005). 47 marshall b. kapp, patient autonomy in the age of consumer-driven health care: informed consent and informed choice, 2 j. realm& biomed. l. 1, 19-20 n.l05, 106 (2006). 48 medicare prescription drug, improvement, and modernization act of2003, pub. l. no. 108-173, 117 stat. 2066 (codified as amended in scattered sections of 42 u.s.c. and 26 u.s.c.). 49 bianchi, supra note 46. 296 indiana health law review [vol. 4:287 surance coverage under a high deductible health plan ("hdhp .. ).50 "an [sic] hdhp is a health insurance plan structured similar to a traditional plan but with markedly higher out-of-pocket deductibles.',s1 usually, the hdhps are re­ quired to have a one-thousand dollar deductible for individuals and a two­ thousand dollar deductible for families before an individual's respective hdhp would begin to cover costs. 52 hsas also tend to be more flexible for the account holder than other cdhps. for example, funds deposited into an hsa carry over from year to year with the only stipulation being that the consumer must meet the required deductible at the beginning of each year.53 furthermore, hsa balances may be withdrawn in cash, and they may be funded by "the eligible individual, his or her employer, a relative, or any combination of these sources . ..s4 the flexibility offered by hsas makes it an appealing alternative to large employers who are looking to reduce health related spending. while hsas may initially be attrac­ tive to small employers, the attraction is mostly favorable numbers small em­ ployers see on paper. employees who decide to open an hsa will realize benefits from a different perspective. they will be forced to become prudent consumers of their own health care by researching, processing, and applying information about which health-related goods and services they should allocate their finances towards. the flexibility of, and tax benefits that flow from, hsas are pwported to be what is likely to push hsas to the forefront as the predominant form of cdhps. "through this mechanism. consumers are encouraged to participate in a genuine market for health care services, making judgments, as with any con­ sumer purchase, as to the utility of spending as opposed to saving 'their' mon­ ey.',ss as a result, consumers have a more direct stake in their own health care expenditures and will likely exercise greater discretion in selecting which mediso according to the mma, an hdhp is a plan that has an annual deductible of at least one thousand dollars for self coverage and at least two thousand dollars for family coverage. additionally, the sum of the annual deductible and annual out of pocket expenses (excluding premiums) does not exceed five thousand dollars for self-only coverage and ten thousand dollars for family coverage. 26 u.s.c.a § 223 (west supp. 2007). 51 j.m. razor,healthsavingsaccounts: increasing health care access inamerica?,l1 loy. consumer l. rev. 419, 422-23 (2005). for a simple discussion ofhdhps and a clear explanation of hsa contribution and distribution, see u.s. 'i'rbasury, ail about hsas (2006), http://www.treas.gov/officeslpublic-a.ffilirslhsa/pall-about-hsas _ 051807 .pdf. 52 michelle andrews, the promise and the pitfalls ofhealth savings accounts, n.y. times, aug. 14, 2005, at§ 3; see also bianchi, supra note 46 (elaborating on the specifics of hdhps and hsas). 53 charles h. klippel, the implications of tea rulings on "savings accounts," in consumer-driven healm carelmpucationsforproviders, payers, and poucymakers 279, 282 (jossey-bass 2004). 54 !d. see also richard l. kaplan, who's afraid of personal responsibility? health savings accounts and the future of american health care, 36 mcgeorge l. rev. 535, 549 (2005). ss jacobi, government reinsurance, supra note 10, at 557. 2007] hsas and small business: cost, quauty, and access 297 cal goods and services they wish to consume, if they even elect to do so at all. 56 consumers also have the choice to inadequately fund their hsas or to forego medical treatment for certain ailments in order to retain funds. medical treat­ ment options may then be limited based on the amount ofhsa funds available to a respective individual. this line of reasoning may have negative implica­ tions because if an employee foregoes treatment due to expense, that same em­ ployee risks exacerbating the condition which will, in turn, cost not only the employee, but also the employer, more in future expenses. in other words, if an employee's condition were to deteriorate, new and more expensive treatment may be necessary thus forcing the employee or their employer to help fund costs associated with the necessary treatment. unfortunately, such a course of action forces one to utilize already scarce, expensive resources driving costs of health care even higher. with hsas, a new wave of health care financing has arrived, but it has been slow to gain in popularity. 57 nevertheless, it is a generally accepted prin­ ciple that the current status of american health care is insufficient to address the needs of america's continually growing population. speaking of the na­ tion's current health care system, one critic of the system suggested that "[ w ]bile increased expenditures represent a stable economic status and evi­ dence of our nation's ability to pay for life extending health care, it is undeni­ able that the ... system is insufficient and unsustainable."58 thus, the move toward cdhc has led to the evolution of a new free market within the health care industry. hsas will likely succeed in "institutionaliz[ing] the individual account approach to medicine, "59 but time will tell whether hsas will reduce health care costs. ill. can hsas successfully achieve cost reduction and universal care? managed care immediately addressed the needs of the american popula­ tion when implemented. ironically, the same system that was designed to lower the cost of health care actually raised expenditures when americans began to seek excessive medical care for minor health related issues. as discussed, once managed care realized this, the system put in place a number of cost contain­ ment strategies that adversely affected the consumer. congress intended the 56 id at 558. 57 for discussion addressing the potential ofhsas, see barry kozak, new health sav­ ings accounts promote consumer driven health care, 18 c.b.a. rec. 58, apr. 2004; angel b. mccall, health savings accounts may reduce health insurance costs, colorado lawyer, 57, jan. 2005; scott e. vincent, irs encouraging use of health savings accounts by issuing model forms, journal of 1he missouri bar. 194, july-august 2004. 58 ganz, supra note 40, at 1. 59 edward zelinsky, the defined contribution paradigm, 114 yale l.j. 451, 508 (2004). 298 indiana health law review [vol. 4:287 medicare prescription drug, .improvement, and modernization act of2003 and its provision creating hsas to be a resolution for the high costs ofhealth care. with "[t]he new millennium announc[ing] a new era, the consumer era. .. . people want to be responsible for their own destiny .... they want to buy goods and services they think they need, exercising what is known as purchas­ ing power.'.6° · generally, consumers prefer to control their own finances and enjoy making informed purchasing decisions. thus, it is imperative that con­ sumers have the ability to access, analyze, and apply available information61 in order for the consumer to make ''an informed decision about the type and amount of health care to purchase. "62 the problem is ascertaining, even with access to this information, whether the patient has the ability to compare the quality of health care of one provider to the quality of health care available within the rest of the market. 63 educating consumers on the type of responsible research thalis necessary prior to making purchasing decisions within the health care market is essential because ifhsas are to be successful it will re­ quire educating the population on the costs and alternative cheaper methods of health care. intelligent consumers will theoretically be more prudent consum­ ers, subsequently lowering health care costs. tied closely with the costs of health care is public access to health care. by lowering costs, access should be increased to those who were previously unable to afford quality health care. a. cost reduction the rise in health care costs can be attributed to a number of factors such as patients' inability to pay, poor hospital management, governmental regula­ tions and compliance costs, and expensive advancements in health care tech­ nology.64 the inherent nature ofhsas is to reduce these costs by increasing information technology, such as information available over the internet that is available to the consumer thus empowering them to make more informed pur­ chasing decisions. 65 the internet is likely the least expensive means of deliver­ ing information to large segments of the population. the problem, however, is that even if this information is made available through government supported financing and legislative action aimed at developing minimum technological 60 alvaro salas-chaves, consumer-driven health care an international view, in consumer-driven iiealti:i care: impucationsforproviders,payers,and poucymakers 362, 363-64 (jossey-bass 2004). 61 see thomas l. greaney, how many libertarians does it take to fix a health care system?, 96 mich. l. rev. 1825, 1831 (1998)(stating that information in the health care indus­ try is insufficient causing consumers to unnecessarily place greater reliance on provider judg­ ments). 62 jacobson, supra note 27, at 391. 63 /d. 64 kelsey d. patterson, healing health care: fixing a broken system with information technology, 14 kan. j.l. &pub. pol'y 193, 195-98 (2004). 65 id at 203-14. 2007] hsas and smail business: cost, quauty, and access 299 standards, the costs associated with, and lengthy processes involved, would do little to address the immediate needs of the marginalized population in amer­ ica.66 hsas compound these issues because an hsa is distinct from managed care and traditional insurance because they place a higher burden on consumers with respect to their health care consumption decisions.67 health care consum­ ers now, more than ever, must be aware of what goods and services are neces­ sary to purchase, what a fair market price is for those goods and services, and whether less expensive, yet higher quality, alternative care options are avail­ able.68 the ability to redress these issues ex ante is difficult even with adequate information about the choices of health care providers of course, the immediate success ofhsas and cdhps typically depends on the consumer's ability to select health care wisely. one critic suggests that success depends on two assumptions: first, that the consumer will make the most cost-efficient purchasing decisions, and second, that consumers will not face buyer's remorse about their ex ante decision once they become patients.69 consumers often do not consider the need for future traumatic health care, and ''when [a] transplant is needed, the consumer [becomes] a patient and may re­ sist enforcement of any contract that denies coverage."7° convincing consum­ ers about the importance of their spending decisions plays an important role in the educational process of implementing hsas and may help move away from judge-made insurance, which is often the result of a health care consumer's spending decisions. consumer education on health care selection may also lower costs by im­ proving consumer bargaining positions. currently, a dichotomy in bargaining for contractual health care rights exists between consumers purchasing health care in their capacity as consumers versus patients. disparities in bargaining power can have detrimental effects on the consumer's ability to obtain a favor­ able contractual provision from a "stronger'' health care provider. 71 consumers purchasing health care in their capacity as consumers are likely to experience this disparity when they arrive at the proverbial negotiating table because they lack the necessary information needed to place them in a superior bargaining 66 information is commonly accessed via the internet and is usually too difficult to ana­ lyze and interpret to be of any use to the consumer, especially consumers lacking formal educa­ tion. louise g. trubek, lawyering for a new democracy: public interest lawyers and new governance: advocating for health care, 2002 wis. l. rev. 575, 589 (2002). 67 jennifer l. spiegel, comment. employee driven health care: health savings ac­ counts, more harm than good, 8u.pa.j.lab.&emp.l. 219,223-24 (2005). 68 id. 69 mariner, supra note 30, at 514-17 (discussing skepticism that complete information disclosure may still be insufficient to meet consumer needs and promote cost efficient consump­ tion). 70 id. at 515. 71 barnhizer, supra note 12. 300 indiana health law review [vol. 4:287 position. 72 the very nature of a consumer acting as a patient places one in an inferior bargaining position because the consumer must obtain medical care in some fashion leaving little room for negotiation. furthermore, when contract­ ing for health care, consumers, acting in either capacity, encounter arbitration clauses denying them the ability to sue and "strip [ping] them of a valuable right at a time when they might be at their most vulnerable.'m thus, education would create awareness and increase bargaining power among consumers help­ ing to drive down costs. hsas, however, rely on the premise that those utilizing them as a form of health care fmancing will act as prudent consumers. the problem is that in the health care marketplace, americans are not acting like consumers because their role is too passive. 74 when an individual is not held financially responsible for his or her spending and consumption decisions, there is no incentive to curtail spending. the current health care system provides consumers with no restric­ tions regarding their spending decisions, creating a subjective decision to be made by each consumer as to what goods and services are medically necessary. ascertaining what each individual consumer will subjectively demand with regard to medically necessary health care services creates arbitrary, and poten­ tially dangerous, outcomes. one individual may believe that an expensive pre­ scription antibiotic is the only way to remedy a common sinus infection, while another individual may choose to wait because they do not want to take time to visit the doctor to obtain a prescription. nevertheless, in both scenarios neither consumer is considering the financial impact of his or her decision. each deci­ sion is made based upon personal preference rather than sound medical knowl­ edge as to the ramifications of choosing one approach over the other. another drawback is that hsas leave to the consumer the responsibility of considering difficult treatment decisions when the need for such treatment is unforeseeable. 75 it seems that most americans do not like to consider such see72 see george w. bush, president of the united states, the president's address to the nation (jan. 24, 2004), available at http://www.whitehouse.gov/news/releases/2004/0l/20040 124.html ("we should help more small businesses afford health insurance for their work­ ers by allowing these firms to band together and negotiate for lower insurance rates. these as­ sociation health plans give small employers the same bargaining power as big companies, making it easier for them to provide employee health coverage.") (statement ofpresident bush). 73 katherine kuhn galle, the appearance of impropriety: making agreements to arbi­ trate in health care contracts more palatable, 30 wm. mitchell l. rev. 969, 970 (2004). but see morreim. supra note 33. 74 edward larson & marc dettman, the impact ofhsas on health care reform: preliminary results after one year, 40 wake forest l. rev. 1087, 1107 (2005). "(o]ne of the big problems we have in health care today is we do not act like consumers. we have third-party payers paying the bills, and so when we go and pay for health care, someone else is paying the bills, so we really do not care how much it costs. that is one of the reasons why the costs ofhealth care are going up through the roof." ld. (quoting representative ryan, 149 cong. rec. 6005). 75 see jacobi, consumer directed health care. supra note 11, at 556-57. 2007] hsas and small business: cost, quauty, and access 301 narios until they are forced to confront them directly. consequently, americans with hsas may not plan ahead for health coverage that falls under the hsa minimum deductible. hsas were designed to place the health care expenses that fall under the deductible on the shoulders of the consumer.76 this means that the responsibility of providing the first several thousand dollars of coverage is left up to the consumer. if the account is underfunded when coverage is needed, a respective consumer may elect to forego treatment. thus, the failure to plan ahead on a large population scale may lead to unforeseen problems with hsas, such as creating an economic class impoverished by excessive medical expenses. 77 so while hsas posit to reduce health care costs and subsequently increase the amount of americans able to afford health coverage, they are subject to drawbacks that will ultimately prevent them from fulfilling their goal of in­ creasing health coverage for americans and decreasing the amount americans are paying for health care.78 these drawbacks include employers replacing low deductible plans with hdhps but failing to contribute appropriately to hsas; the ability of only wealthy employees to contribute their own funds to hsas in the aforementioned situation; and younger and healthier employees' willingness to choose hdhps with hsa addons contrasted with older/9 and unhealthier employees' desire to continue using low deductible health plans driving the cost even higher. 80 since the inception ofhsas, opponents to the program have questioned the actual cost-effectiveness of implementing such a plan. one principal argu­ ment states that the segments of society with the highest health care spending will not be affected by the implementation ofhsas.81 hsa critics state that 76 razor, supra note 51. 77 see also larson & dettman, supra note 74, at 1093-96 (explainingthatmanyfamilies who lack health insurance during medical emergencies suffer extreme financial difficulty by being forced to bear the cost of care); andrews, supra note 52 (briefly examining the potential promise and setbacks that may be experienced with hsas). but see john torinus, fix for health care costs rests in hands of consumers, the milwaukee j. sentinel, july 24,2005, at d3 (advocating that the five year track record ofhsas is enough to prove cdhps are suc­ cessful in lowering health care costs). 78 see generally kozak. supra note 57. 79 while hsas may appeal to younger, healthier employees, it should be noted that, according to a survey published by the u.s. bureau of labor statistics, in 1997 american work­ ers ages 16-34 comprised roughly thirty-four percent of the working poor. see bureau of labor statistics, young adults most likely to be among the working poor (1999), available at http:/ /stats.bls.gov/opub/ted/1999/sept/wk2/art03 .htm. 8° kozak, supra note 57, at 60 (suggesting only the wealthy employees will be able to afford to contribute to hsas). however, many americans who are employed by small busi­ nesses earning nominal wages cannot afford to contribute enough to an hsa to meet the high deductible requirements. consequently, this class of workers may continue to avoid seeking and securing health coverage. see small business health plans, supra note 16 (providing statistics illustrating that small business employees generally produce smaller incomes than employees at larger firms). 81 razor, supra note 51, at 440. 302 indiana health law review [vol. 4:287 even ifhsas were adopted by employers across the nation, the health care in­ dustry would only experience a decline of two percent in health care costs. 82 in his testimony before congress, robert greenstein, the executive director for the center on budget and policy priorities, stated that tax savings offered by hsas were not incentive enough for persons in the ten to fifteen percent tax brackets to purchase into a hsa.83 thus, ifhsas cannot provide enough tax incentive for those consumers in the lower income brackets, then only the healthier, higher wage earning members of society will shift toward using the hsa model. 84 the subsequent effect would result in insurance companies in­ suring a poorer, less healthy segment of society, 85 which will cause premiums to increase. the effect ofhsas will become difficult to realize unless they are imple­ mented on a large scale. 86 by increasing the aggregate risk pool a greater de­ gree of bargaining power would be created among patients utilizing hsas to fmance their health care needs. 87 in a recent survey of member companies of the international society of certified employee benefit specialists, ninety-six percent indicated that their companies did not offer hsas. 88 when asked what the most important reason to offer hsas to employees would be, fifty-seven percent of employers responded that the main reason to offer the plan revolved around costs.89 ironically, despite employers' faith in hsas to control costs, forty-nine percent were undecided when asked if they would offer hsas as a form of health care fmancing to their employees. 90 although the results of this survey are by no means conclusive, they do provide a good indication of the general sentiment employers have regarding hsas. the indication is that there is confidence among employers that hsas will reduce costs but there neverthe­ less remains reluctance by employers to provide an hsa option for their em­ ployers. without a popular movement toward implementing hsas on a large 82 health savings accounts and the new medicare law: the face of health care's future?: hearing before the special senate comm. on aging, 108th cong. 41-56 (2004) (statement of robert greenstein, executive director, center on budget and policy priorities). 83 id. 84 larson & dettman, supra note 74, at 1122-23 (citing an industry-wide study on the effects of cdhps as stating that hsas "are designed only to 'cherry pick' the young and the healthy; [they] do not adequately address the special needs of the chronically ill, acutely ill, and lower-wage employees."). 85 spiegel, supra note 67, at 230. 86 kaplan, supra note 54, at 565. see also small business health plans, supra note 16 (stating that house republicans passed legislation allowing small business owners to unite by associations and purchase health care at a discount, thus enabling the savings to be passed on to the consumer). 87 /d. 88 john c. garner, int'l soc'y certifjed employee benefit specialists, predicring the future of health sav1ngs accounts, available at http://www.iscebs.org/­ pdf/hsa_survey.pdf. 89 id. 90 id. 2007] hsas and small business: cost, quality, and access 303 scale, hsas will remain unable to resolve the immediate health care crises fac­ ing the working poor in america. b. access to health care goods and services in addition to solving the fmancial cost issue, it is also important to con­ sider the implications of physical access to high quality health care. patients living in less economically stable communities will experience the greatest dif­ ficulty physically accessing health care facilities. "[w]ith hospital construction taking place mostly in affluent areas and technology not making its way as much into hospitals in less-affluent areas, the quality of care for the poor may be falling behind."91 not only are the poor unable to secure access to higher quality health care, but the inability to do so may result in the need for more care which will increase costs for providers and patients. two important factors drive consumer utilization ofhealth care goods and services: 1) the ability to pay, and 2) the ability to gain physical access to goods and services.92 the inability to afford quality health services can often be at­ tributed to socio-economic status.93 this is demonstrated by the fact that insur­ ance coverage is usually tied to employment, and employers who hire low wage earners are more reluctant to offer health coverage plans.94 one problem driv­ ing health care costs higher revolves around a consumer's decision not to seek treatment because of the extreme cost of health care. a recent survey found that forty-seven percent of uninsured postponed care because it was too expen­ sive and thirty-seven percent did not fill prescriptions because the cost of medi­ cine was too high. 95 the access problems created by hsas are created by the high deductible requirement and the necessity of accumulating funds in order to realize the benefits of the accounts.96 the effect is that patients will often avoid necessary medical care in an attempt to accumulate funds or to avoid pay­ ing the high deductibles. as a result it is highly probable that the severity of their condition will worsen, and more expensive advanced care will be required to treat the ailment. cost reduction is an imperative step toward securing access to health care for americans unable to afford such care. often times, impoverished ameri91 joesph mantone, incentives linked to access woes, modern realm care, dec. 12, 2005, at 10. 92 anita pereira, note, live and let live: health care is a fundamental human right, 3 conn. pub. int. l.j. 481,487 (2004). 93 henry j. kaiser fam. found., the kaiser commission on medicaid and the uninsured: the uninsured and their access to health care (2003), available at http://www.kff.orgluninsuredlloader.cfin?ur1=/commonspot/security/getfi1e.cfin&pageid=29284 94 pereira, supra note 92, at 483-84. 95 id. this survey also noted that thirty-six percent of the uninsured had difficulty in paying their medical expenses and twenty-three percent were contacted by a collection agency about medical related expenses. 96 larson & dettman, supra note 74, at 1112. 304 indiana health law review [vol. 4:287 cans face lifestyle problems such as poor nutrition and unsanitary living condi­ tions97 and are unable to afford health care that may help them change these lifestyles. access to health care would increase public knowledge about the correlation between poor nutrition and unsanitary living conditions and health concerns. furthermore, the working poor are often employed in "low-wage jobs working for small employers in the retail or service industry. "98 these types of employers generally offer fewer health benefits than their larger coun­ terparts.99 moreover, the working poor100 who are employed at several part­ time jobs experience roughly four times less access to health care benefits than they would if they worked one full time job. 101 lack of education and market­ able job skills, however, are often associated with the impoverished classes, and as a result, securing a full-time job that offers health care benefits may be more difficult. these unhealthy employees will have higher health care expenditures and will likely be dissuaded from hsas because they will not have the opportunity to accumulate any funds in their account. 102 but according to some proponents, ''the tax-free payment of expenses and lower insurance premiums" may provide enough of a benefit to act as an incentive.103 the ''working poor" in america, 97 walter l. stiehm, poverty law: access to healthcare and barriers to the poor, 4 qulnnipiac healtii l.j. 279, 279 (2001). see also richard epstein, moral peril: our inalienable right to healtii care? 112-13 (addison-wesley publ'g co., inc., 1997) (ex­ plaining that the solution to solving america's inability to provide universal health coverage is not going to be found in consumer driven plans; rather, it will require changes that equalize the opportunities of life across america's population). 98 stiehm, supra note 97, at 287. 99 according to a national compensation survey conducted by the united states bureau oflabor statistics, establishments with under one hundred workers offered medical benefits, on average, to fifty-nine percent of their employees. goods producing establishments offered med­ ical benefits to eighty-five percent of their employees while service producing establishments offered medical benefits to only sixty-six percent of their workers. as ofmarch 2005, part-time employees in america's private industry realized medical benefits only twenty-two percent of the time compared to full time employees who received medical benefits 85% of the time. u.s. bureau of labor statistics, national compensation survey: employee benefits in prnate industry in the united states (2005), available at http://stats.bls.gov/ncs/ebs/­ sp/ebsm0003.pdf. 100 the term "working poor'' is defined by the united states department oflabor as "in­ dividuals who spent at least 27 weeks in the labor force (working or looking for work), but whose incomes fell below the official poverty level." u.s. dept. of labor, a profile of the working poor 2000 (2002), available at http://www.bls.gov/cps/cpswp2000.htm. 101 u.s. bureau of labor statistics, supra note 99. see also kaplan, supra note 54, at 543 ( "[i]n an employment-based health insurance system, the loss of one's job seriously jeop­ ardizes a person's access to health insurance."). 102 see daniel lublin pollock & natalie e. ranier, sixth annual review of gender and sexuality law: vi health care law chapter: health care access: a review ofmqjor barriers to health care services for women, 6 geo. j. gender & l. 825, 845 (2005). see spiegel, supra note 67, at 231-32 (questioning the effectiveness ofhsas to decrease health care related expen­ ditures). 103 [i]t may be impossible to accumulate an hsa account balance if medical 2007] hsas and smail business: cost, quality, and access 305 those who earn too much to obtain government help and too little to afford quality health care,104 however, may not have the opportunity to contribute to hsas in a manner significant to take advantage of the aforementioned bene­ fits.105 this may be because their wages are being used to finance other living expenses or continuously being applied to the high deductibles that hsas re­ quire. a recent survey illustrates the inability ofhsas and hdhps to resolve the immediate need to provide broad health coverage to the nation's low wage earners, including those employed by small business owners.106 the survey reported "[h ]ealth insurance premiums for a family of four now average almost $11,000 a year."107 the reason why small and large finns that employ large numbers oflow wage earners are reluctant to offer health care plan benefits108 is because the cost of providing health care is more than these employees are earn­ ing, 109 thus placing a larger burden on the employer. current health insurance premiums would consume the entire salary of the nation's lowest wage earner for one year.110 as a result, americans with moderate to low incomes may not expenses are high each year, thereby eliminating the tax-free growth poten­ tial. but the tax-free payment of the expenses and lower insurance premi­ ums that are paid by the insured may prove to be enough of a benefit. also, those who have a long-term disability would have to exhaust their deducti­ ble every year. once again, those with long-term illnesses would need to evaluate how the plan would effect them. mccall, supra note 57, at 60. 104 stiebm. supra note 97, at 285. 105 kozak, supra note 57, at 60. 106 kaiser fam. found. & healtii research & educ. trust, employer healm benefits: 2005 summary of findings (2005), available at http://www.kff.org/­ insurance/7315/sectionslupload/7316.pd£ 107 id. see also arnold s. reiman, reforming the u.s. health care system: what the legal & medical professions need to know, 15 heal1hmatrix 423,429-30 (2005) (explain­ ing that impoverished americans in cdhps face a choice of either spending money in their account or not getting the care they need and proposes that a single insurance system funded by corporate tax contributions could resolve the problem). 108 kaiser fam. found. & healm research & eouc. trust, supra note 106. see christopher rowland, 5-7% tax sought on firms for health care, the boston globe, nov. 1, 2005, at ai (discussing a plan unveiled by the massachusetts house speaker, salvatore f. dimasi, to levy a five to seven percent payroll tax on employers in massachusetts who did not provide health insurance to employees). 109 determinations of persons qualifying for medicare are made on an objective case-by­ case basis based upon available income. if employees do not qualify, they become dependent on their employers for health care benefits, and unfortunately, many small businesses do not offer such benefits because they are too expensive. see 45 c.f .r §233.20(a)(l )(iv)(d) (1994) ("to the extent not inconsistent with any other provision of this chapter, income and resources are considered available both when actually available and when the applicant or recipient has a legal interest in a liquidated sum and has the legal ability to make such sum available for support and maintenance."). 110 kalserf am. found. & heal til research& educ. trust, supra note 106 ("gross earnings for someone earning the federal minimum wage in 2005 and working 2,080 hours are $10,712."). 306 indiana health law review [vol. 4:287 have access to quality health care or, for that matter, any health care at all.111 access to health care should not be an issue for americans. health care is an indispensable service that those living in one of the most affluent countries in the world ought to be able to enjoy without having to worry about how to finance their own care. if congress begins to shift its focus toward broad health care access perhaps legislators will begin to realize the importance of providing health care to american citizens, which would awaken legislators to the reality that americans need affordable health care. without equal access among all working citizens, unemployed, and indigent some argue that health care will never be recognized as the fundamental right it is.112 one proponent of heath care access as a fundamental human right categorized accessibility as having four distinct, overlapping elements. 113 the frrst step in providing equal access to health care is making providers implement non-discriminatory practices. 114 this means that unfettered access to the nation's best health care providers must be granted to all people regard­ less of gender, race, and socio-economic status. lis currently, the socio­ economic barriers in america are not allowing this to occur. the implementa­ tion of hsas will only exacerbate this problem among the lower socio­ economic classes because as previously mentioned, one of the flaws surround­ ing hsas is the inability of the indigent to meet the required deductibles. 116 the second element of accessibility concerns one's physical ability to get to health care facilities. 117 this means that adequate health care should be "within safe physical reach for all sections of the population, especially vulner­ able or marginalized groups."118 the third and fourth prerequisites for better system accessibility involve economic and information accessibility.119 this simply means that all aspects of the population should be able to experience quality health care at an afford­ able price. moreover, the entire population should have access to adequate in~ 111 contra mary anne bobinski, health disparities in health care: wrongs in search of a right, 29 am. j.l. & med. 363, 365-66 (2003) (suggesting that socio-economic factors are not the sole reason that there is unequal access to health care and also attributing the inequity of access to health care goods and services to race and gender); epstein, supra note 97, at 112-13 (explaining that the solution to solving america's inability to provide universal health coverage is not going to be found in consumer driven plans, rather it will require changes that equalize the opportunities oflife across america's population). 112 pereira, supra note 92, at 481-90. 113 !d. at 487. 114 jd. 115 jd 116 kozak, supra note 57, at 60. !')li 11 ~ pereira, ~upra note 92, at 488 ("accessibility also implies that medical ~~ces ~~ uftderlymg determmants ofhealth, such as safe and potable water and adequate santtation facili­ ties, are within safe physical reach, including in rural areas. accessibility further includes ade­ quate access to buildings for persons with disabilities."). 118 !d. at 487. 119 !d. at 488. 2007] hsas and small business: cost, quality, and access 307 formation and the necessary means to process that information effectively read­ ily available to assist in making health care consumption decisions. the pri­ mary role ofhsas would be to fulfill the third and fourth categories but would likely do little to address the non-discrimination and physical access require­ ments for equal access. hence, even portions of the population outside of small business employment are unable to secure health care under the current hsa plans that promote a market-based solution. if hsas were intended, at least in part, to reduce health related expenses in this new era of rapidly advancing technology, while likewise, increasing ac­ cess to the american health care system for all, then hsas have not yet suc­ ceeded. too many problems remain regarding how to handle chronic illness, elderly care, and impoverished americans' inability to afford care. iv. small businesses and the uninsured: struggles with hsas america's low-wage earners tend to work for employers who do not pro­ vide health insurance coverage. "typically, the uninsured are unemployed, self-employed, work for small businesses, or work part time. "120 the majority of the american work force is employed by companies with less than fifty em­ ployees. 121 this statistic reflects the propensity of small companies to hesitate in introducing health insurance plans to their employees due to cost.122 the intro­ duction ofhsas, however, will purportedly allow reluctant employers to pass more of the health insurance costs on to their employees. 123 furthermore, hsas actually create an incentive precisely to encourage this type of burden shifting, 124 which is the result that society wants to avoid. costs should not be placed on the shoulders of employees because often times those employees do not have sufficient resources to carry that burden. the question remains, then, as to exactly how effective hsas will be in reducing costs and increasing ac­ cess and quality within the health care industry. while the potential of hsas has been hailed since the passage of the mma, employees of small american businesses have not yet been able to reap the benefits hsas promised to provide. among those small firms, with less 120 larson & dettman, supra note 74, at 1106. 121 l yke, peterson & ranade, supra note 4. 122 ld. 123 see spiegel, supra note 67, at 235-36 (arguing that while hsas implemented in the context of a large employer will tend to shift costs onto the employees, their implementation in the context of small businesses is likely to succeed). 124 l yke, peterson & ranade, supra note 4 ("small employers may also find hsa ac­ counts attractive since they would obtain employment tax savings on employee contributions that are made through salary reductions."). see also h.r. 1872, 1 09th cong. (1st sess. 2005) (proposed by texas congressman, sam johnson, the health coverage for the uninsured act of 2005, among other things, would amend the internal revenue code to allow employers ofless than i 00 employees a refundable tax credit for contributions to a health savings account of em­ ployees covered by high deductible health plans.). 308 indiana health law review [vol. 4:287 than two-hundred employees, only twenty percent offered some type of hdhp.125 more indicative of a small firm's propensity to balk at instituting hsas are data illustrating that only two and three-tenths percent of all ftrms offering health benefits actually offer an hsa qualified hdhp.126 so even if . hsas functionally meet their expectations, their lack of popularity will not ef­ fectuate a change in the health care market in the near future. typically, those lacking health insurance in america tend to be either "young adults, poor, his­ panic, or employees in small firms. ''127 further, while these are distinctive characteristics of individuals lacking health insurance, they are not always ex­ clusive of each other. the urgency for a solution addressing the availability of health insurance to young, moderate wage earners employed by small businesses is ofutmost importance. proponents ofhsas as a solution to small business health insur­ ance problems suggest that hsas combined with a hdhp "lowers the insur­ ance rates for an employer, allowing small businesses to fit health insurance into their budgets."128 in a radio address to the nation, president bush echoed this sentiment when he stated, "[a] new product known as health savings ac­ counts helps control costs by allowing businesses or workers to buy low-cost insurance policies for catastrophic events and then save, tax-free, for routine medical expenses."129 critics of hsas, however, suggest that this form of health coverage will only appeal to the affluent, healthy workers seeking to take advantage of tax shelter benefits.130 this is because persons who fit into this category likely do not wish to expend their financial resources on traditional insurance due to their underutilization of the services for which they are paying. when individuals contribute their own financial resources to the account, they are more likely to obtain medical goods and services only when truly needed. 125 kaiser f am. found. & realm research & educ. trust, supra note 106. the statistics from the survey reflect a ten percent increase among small firms offering an hdhp in 2005. the survey notes, however, that this increase may be attributed to the evolving definition ofhdhps. 126 id. 127 chris l. peterson, cong. research serv., realm insurance coverage: characteristics of tile uninsured and uninsured populations in 2001 (jan. 7, 2003), available at http:/lwww.law.umacyland.edu/marshall/crsreports/crsdocuments/96-891 _ epw.pdf. specifically, persons between the ages of nineteen and thirty-four comprise thirty­ four percent of the uninsured population. furthermore, fifty-one and nine tenths percent of the uninsured population is employed by firms with fewer than one hundred workers. 128 raynal. payola, univ. ofrhodeisland,realmsavingsaccounts:arehsas beneficial from tile employee's view? arehsas beneficialfromtiieemployer's view? (2005}, available at www.uri.edu/research-/lrcipapers!paola _ hsa.pdf (2005). 129 president george w. bush, radio address, economy and small business (jan. 21, 2006), available at http://www.whitehouse.gov/news/releases/2006/01/20060 12l.html. 130 edwin park & robert greenstein, ctr. budget & pol'y priorities, latest enroumentdatastillfall..todispelconcernsabourrealmsavingsaccounts(2006}, available at http://www.cbpp.org/10-26-05health2.htm# _ fbrref5; see also spiegel, supra note 67, at 230; peter g. gosselin, health plan to revive debate, l.a. times, jan. 23, 2006, at al. 2007] hsas and small business: cost, quauty, and access 309 furthermore, rather than contributing finances to traditional health insurance models, hsas allow one to contribute and use funds in the account tax-free, which is appealing to young workers. because hdhps appeal primarily to the healthier, more affluent workers, it has been suggested that "the average cost of insuring any given risk pool will increase, likely causing both premiums and overall health care expenditures to rise dramatically. "131 in other words, the "health demographics~'132 of risk pools will dramatically shift, thereby leaving the poor, sick, and otherwise unhealthy to be insured by their respective insurers. as a result of the inability to spread the costs of this risk among the healthy and ill alike, the costs of insurance will increase. the fallout from such a shift would likely fall heaviest upon the mid­ dle to lower income financial brackets already experiencing difficulty in financ­ ing their health care. also problematic, and perhaps disheartening, is the fact that many insured families are facing bankruptcy more often than their uninsured counterparts as the result of catastrophic illnesses.133 often times the associated medical ex­ penses are well below the catastrophic minimums required by hdhps.134 if insured families are facing difficulty in financing catastrophic illnesses, unin­ sured families are at an even greater risk for financial instability. this presents yet another problem with regard to maintaining costs and increasing access to care. uninsured families may be granted access to care in the event of a catas­ trophic accident or illness, but the costs of the care will be redistributed. 13s in this scenario, the family will likely be forced into bankruptcy and costs for the uninsured's inability to pay will be passed alon~ by the providers to other pa­ tients in the form of higher health care costs.1 6 bankruptcy reform propo­ nents137 have suggested confronting this dilemma by "providing unconditional 131 spiegel, supra note 67, at 230. see also editorial, the lopsided bush health plan, n.y. times, feb. 3, 2006, at a22 (warning of the potential dangers if healthy employees all jump to hdhps). 132 the term "health demographics" is used here to describe the make up of a particular risk pool. for example, the health demographics of a young, affiuent, risk pool are going to reflect a healthier population as opposed to an older, poorer risk pool that will likely reflect greater occurrences of illness in the health demographics. see spiegel, supra note 67, at 230 (discussing how adverse selection will likely negatively affect the average cost of insuring a respective risk pool). 133 larson & dettman, supra note 74, at 1121 (citing david u. himmelstein et al., rlness and injury as contributors to bankruptcy, health aff. web exclusive, at w5-63, w5-66, feb. 2, 2005). 134 id 135 /d. (medical related spending in the year that families experienced catastrophic illness nearly quadrupled from the previous year. "[researchers] explained, 'in the year prior to bank­ ruptcy, out-of-pocket costs (excluding insurance premiums) averaged $3,686 .... out-of-pocket costs since the onset of illness/injury averaged $11,854. "'). 136 /d. 137 /d. this suggested bankruptcy reform proposal seems to be antithetical to the premise behind hsas of encouraging fiscal responsibility. /d. 310 indiana health law review [vol. 4:287 debt relief to individuals who legitimately use bankruptcy as insurance of last resort in the aftermath of serious calamities. "138 while this may alleviate the immediate problems of the uninsured family, this solution does nothing tore­ solve the issues of access and increased cost for the working poor population as a whole. providers are still going to pass the costs on to future patients, and these high costs are likely to dissuade the uninsured from seeking treatment. as the burgeoning american population continues to grow, 139 it is impor­ tant to focus resources on and tailor solutions to this targeted area ofhealth care consumers so that the problems of inadequate access for america's moderate to lower income brackets may be halted in its infancy. without a solution specifi­ cally tailored to address the lower income segments of the population, health care availability in america will remain stagnant and may begin to decline with the continued adherence to the hsa model within the context of small busi­ nesses. v. promising alternative solutions to the high costs of health care there have been many suggestions concerning how to remedy the pending health care crisis in america. most notably and widely advocated, is the push toward a government regulated health care systern140 consistent with that of most other developed nations.141 because of most americans' reluctance to subscribe to a universal health care approach, the preferred method seems to be an incremental approach attempting to fix aspects of the system piece by piece; 138 melissa b. jacoby, collecting debts from the ill and injured: the rhetorical signifi­ cance, but practical irrelevance, of culpability and ability to pay, 51 am. u.l. rev. 229, 231 (2001). 139 the united states census bureau estimated that the population in america grew by an estimated 2, 753,562 persons from july 1, 2004 to july 1, 2005. natural birth increased the pop­ ulation by 1,704,036 and international documented immigration grew the population by 1,049,526. u.s. census bureau, population division, table 5: annual estimates of tile components of population change for 1he united states and states: july 1, 2004 to july 1, 2005 (2005), available at htlp:llwww.census.gov/popest/states/tables/nst -est200505.xls. 140 see hampton, america's flight from health insurance, supra note 1 (suggesting that americans should not subscribe to the myth that the health care market will allocate resources more efficiently than the government); jacobi, government reinsurance, supra note 10 ( advo­ cating that the government assume catastrophic coverage costs and leave nominal health costs to consumers). 141 see pereira, supra note 92, at 50 l (suggesting that universal coverage is not the only answer to solving access problems within the united states; rather, simply recognizing health care as a fundamental human right and eliminating poverty is the first step toward increasing access problems). pereira's argument seems a bit overly ambitious within a capitalistic society of which poverty is an inherent part. a true solution would maintain the spirit of capitalism outside of the health care marketplace and place the regulation of this marketplace under gov­ ernment control. eliminating poverty is a noble undertaking but may be too complex of a solu­ tion to increasing access to health care. 2007] hsas and small business: cost, quauty, and access 311 such an approach has been deemed to be inefficient. the problem with this idea is not only the amount of time it takes to implement the new plan, but more importantly, the amount of time that must pass before results of the new system can be realized. for example, hsas have been implemented for almost three years at this point, yet only two and three tenths percent of employers142 are offering them as a solution to health care benefits. therefore, a non-incremental solution to the federal government's con­ tinuing piecemeal approach may be in order. short of a complete transition to universal health care, there are several other possibilities that may help remedy the access and cost problems facing america's working poor. among these solutions are greater emphasis placed on consumer education, organization of consumer factions to effectuate change on a larger scale, and president bush's association health plans. 143 a. consumer education in order for consumers to make educated purchasing decisions, a greater emphasis must be placed on the importance of providing adequate information that addresses how to avoid underfunding hsas, illustrates provider perform­ ance information, 144 discloses costs of medical goods and services, 145 coaches consumers on how to judge the quality ofhealth care, 146 and informs consumers as to how this information applies to hsa and their accompanying hdhp. the idea behind providing consumers with more information is to make them more powerful yet prudent consumers of health care goods and services. access to high quality information creates individual bargaining power, especially if one can analyze that information appropriately and is willing and able to use it. 147 legislation mandating the standards of information disclosure centering on the health care industry should be enacted. possible legislation may include mandating the completion of some type of educational program illustrating to consumers how to interpret complex information provided by the health care 142 kaiser f am. found. & healrn research & educ. trust, supra note 106. 143 u.s. chamber of commerce, small business health plans, http://www.uschamber.­ com/issues/indexlhealth/ahps.htm (last visited mar. 25, 2007). 144 kate sullivan, dir. healthcarepol'y, u.s. chamberofcommerce, testimony before the united states house ofrepresentatives small business subcommittee on workforce, em­ powerment, and government programs: the benefits of health savings accounts (mar. 18, 2004), available at http://www.uschamber.com/nr/rdonlyreslexwu6pctkeizcdxqr4vmfgoise3cqvhtaldlg4urmp4pc22yobfc34fsjpw3qrorgena5pevp7wa4m/healthsavingsac­ countsmarch1820040.pdfflsearch='health%20savings%20accounts%20small%20employers%2 oaftluent'. see also herzlinger, supra note 42; mariner, supra note 30, at 514-17 (suggesting that even with complete information disclosure, this may still be insufficient to meet consumer needs and promote cost efficient consumption). 145 sullivan, supra note 144. 146 jacobson, supra note 27, at 391. 147 barnhizer, supra note 12, at 167. 312 indiana health law review [vol. 4:287 industry. this type of information is essential to successfully managing the recently opened hsa internet-based courses that are a possible solution for the nation's younger generations because of the ease of access and familiarity this segment of the population has with the world wide web. even if one does not have private access to a web-based learning program, many public libraries across the nation148 offer free access to the world wide web where the pro­ grams could be completed. for those without internet access, traditional com­ munity learning courses could be offered at local churches, schools, or community centers addressing the same topics covered by the internet courses. furthermore, when drafting legislation to implement information disclosure programs, congress should consider the consuming public, rather than health care experts and competing health care providers, as the primary audiences of any disclosed information pertinent to cdhps.149 the objective of this type of mandate would be to consolidate information into easily translatable informa­ tion that is the most relevant to key consumer decisions. an increase in the availability of a web-based learning system would al­ low easier access for the entire gamut of american society. if congress were to mandate the passage of these web-based learning courses, then america could rest assured that best efforts had been made to inform the consuming public about the types of decisions involved with managing a hsa. informed con­ sumers are prudent consumers able to allocate financial resources efficiently. if implemented successfully and adopted by consumers, this may help bolster the argument that market forces will be able to succeed in reducing costs associated with health care. 150 b. organized consumer bargaining factions individual consumers lack the requisite bargaining power necessary to ef­ fectuate a transformation in american health care costs. if a large population of americans could organize into consumer bargaining factions, this may help increase their bargaining power as a united class. price is a contractual term 148 as of 2004, over ninety-five percent of america's public libraries offered internet access. furthermore, families earning less than fifteen thousand dollars per year were two to three times more likely to use public internet access at these locations than were families earning over seventy-five thousand dollars per year. public libraries boost internet access, early lit­ eracy, usa today, feb. 6, 2004, available at http://www.usatoday.com/news/education/200402-26-librarian-convention x.htm. 149 but cf william m. sage, regulating through information: disclosure laws and american health care, 99 colum. l. rev. 1701, 1792 ( 1999)( suggesting that in the context of managed care, in order to improve productive efficiency, the consumers are "not the most mean­ ingful audience"). 150 but cf hampton, america's flight from health insurance, supra note 1 (suggesting that health care provisions are better left to the federal government than to traditional market forces). 2007] hsas and small business: cost, quality, and access 313 particularly subject to negotiation. 151 consequently, if the working poor in america can mobilize and present themselves as a unified group to health care providers, they may be able to effectuate a change in health care pricing. in order to do this, it will be necessary for the consumer faction to illus­ trate that its members are prudent, informed consumers capable of making effi­ cient purchasing decisions. "as a practical matter, poor individuals often do lack bargaining powerthe power to obtain a preferred outcome in a transac­ tion .... "152 if these individuals are able to organize on a large scale into con­ sumer factions, however, it is likely that health care providers will recognize the purchasing power of these factions as they relate to necessary medical ex­ penses. on the other hand, this type of recognition may arise naturally if the market within the health care industry functions efficiently. the idea behind organizing consumers into collective groups is based on the theory that those consumers joining the faction will be responsible, prudent consumers as a result of the education they received from the previous proposi­ tion for a mandated web-based hsa educational program. moreover, these consumer factions will be unsuccessful unless they are implemented on a large scale. their ability to influence depends heavily on the number of consumers for whom these factions will be negotiating. with the ability to organize, poor­ er employees, as individuals, will gain a considerable amount of bargaining power through these factions that may help them obtain the ability to negotiate end prices more effectively within the health care market. c. health security for all americans act in may of2005, members of the house ofrepresentatives took the goal of obtaining affordable, high quality health care a giant leap farther when nine­ teen representatives introduced into the house, the health security for all americans act. 153 the health security for all americans act ("hsaaa") establishes as its goal "[t]o guarantee for all americans quality, affordable, and comprehensive health insurance coverage."154 the hsaaa purports to accom151 barnhizer, supra note 12, at 212. 152 id. at 152. 153 health security for all americans act, h.r. 2133, 1 09th cong. (2005). the health security for all americans act is similar to the health security act proposed by former presi­ dent bill clinton in 1993 which failed largely becanse it lacked the requisite backing of con­ gress and the american public, but its failure has also been attributed to the complexity of the legislation. see linda m. harrington, health care reform vs. pet goals; in congress, illinoi­ sians mostly aimingfor crime bills, cm. trm., jan. 22, 1994, at n1; amy goldstein & terry m. neal, on the road, away from crises; clinton's pitch on health care reflects lessons learned in '94, wash. post, aug. 11, 1998, at ai (stating that former president clinton's health care reform platform was short lived, losing momentum and dying only one year after it was first introduced). 154 h.r. 2133, 1 09th cong. (2005). see also press release, baldwin announces legislation to cover the uninsured (may 10, 2004), available at 314 indiana health law review [vol. 4:287 plish this proposition by implementing its requirements in two phases. the first phase involves implementing voluntary state plans155 as a test run. the voluntary state plan phase asks participating states to establish sys­ tems that are responsible for ensuring universal coverage within the state, and provides for federal funding to states participating in the program. 156 for the second phase, the hsaaa calls for the mandatory implementation of state plans. 157 under the hsaaa, states are required to submit to the secretary a plan breaking down how that particular state intends to use the federal funds to establish a universal health care program within their jurisdiction.158 the hsaaa arose in light of congressional findings regarding the status ofhealth care costs and how these costs relate to public consumption. among these findings include statistics that indicate personal spending on health care is growing two and five-tenths percent faster than the gross domestic product of the country. 159 moreover, americans are paying two times as much for health care than they were a decade ago, 160 and health care administrative costs per person are more than five times greater than other industrialized countries that have implemented a universal health care plan.161 in other words, health care costs are substantially higher and are continuing to grow at a rapid rate due to the reluctance of americans to embrace a universal health care system similar to the one suggested by congresswoman tammy baldwin. one downfall of the hsaaa is that it does not set forth from where the source of government financing will come. surely, congresswoman baldwin did not intend the hsaaa to cover all related medical expenses, including non-essential costs. as one critic commented, "someone must establish a limit on which services are and are not covered in any government subsidized health care program. the issue becomes one of who will set the limits and what those limits will be."162 congresswoman baldwin's answer seems to point toward the states as being responsible for implementing fifty separate universal health care systems unique to the needs of each state. 163 although, on its face, the hsaaa seems to gravitate toward a universal solution, as a practical matter it is not likely to succeed. this is largely because in its application, the bill is just anhttp:/ /tammybaldwin.house.gov/prarticle.aspx?newsid=373 [hereinafter baldwin announces legislation to cover the uninsured] (congresswoman baldwin's website reports that "[t]he bill will secure health insurance for all americans, guarantee affordable health care by limiting out­ of-pocket expenditures, provide comprehensive health care by guaranteeing a minimum benefit package equal to the benefits offered to members of congress, and ensure the quality ofhealth care b(sproviding strong patient protections."). 5 h.r. 2133, 109th cong. (2005). 156 h.r. 2133 §2201(bx1)-(2), 109th cong. (2005). 157 id §2211 (ax1)-(2). iss /d. § 2211. 159 id. § 2(8). 160 id. § 2(12). 161 see id. §2(14). 162 stiehm, supra note 97, at 291. 163 see h.r. 2133, § 2211 ( a)(l ), 1 09th cong. (2005). see also baldwin announces leg­ islation to cover the uninsured, supra note 154. 2007] hsas and small business: cost, quality, and access 315 other piecemeal attempt toward universal health care that is genuinely federally regulated. the problem with hsaaa as written may be that it allows too much subjectivity on the part of each individual state's legislature. universal health care benefits would fluctuate from state to state based on their interpreta­ tion of what medical goods and services should be covered. thus, the health security for all americans act is a good solution on its face but is not likely to succeed in its goal of providing universal coverage. in order to accomplish this, the hsaaa should be redrafted to make health care regulation a "true" function of the federal government rather than leaving regu­ lation and implementation on the states' shoulders and placing the fmancial burden on the federal government. to secure an immediate solution to rising health care costs and obtain universal health care in the united states, it is nec­ essary to make regulating, implementing, and financing the health care industry a job for the united states government. d. association health plans (small business health plans) in a radio address to the nation, president bush spoke about hsas as a potential solution to controlling cost and increasing access to health care in america.164 the text of the address illustrates that america's leadership recog­ nizes the deficiency that exists between small businesses versus large corpora­ tions with respect to financing health care costs. for the sake of america's small businesses, workers, and families, we must also make health care more af­ fordable and accessible. a new product known as health savings accounts helps control costs by allowing businesses or workers to buy low-cost insurance policies for catastrophic events and then save, tax-free, for rou­ tine medical expenses. this year, i will ask congress to take steps to make these accounts more available, more affordable, and more portable. congress also needs to pass association health plans, which allow small busi­ nesses across the country to join together and pool risk so they can buy insurance at the same discounts big companies get. 165 the association health plans ("ahps") proposed by president bush take on a function similar to that of the aforementioned consumer factions. the idea behind ahps is to group small businesses together in order to increase bargain164 president george w. bush, supra note 129. 165 /d. 316 indiana health law review [vol. 4:287 ing power when negotiating with insurance companies for lower prices.166 in addition, ahps will allow small business owners to expand business, share risk with other small businesses, and provide benefits for employees. 167 according to the united states chamber of commerce, the introduction of ahps would increase coverage by roughly eight and a half million ameri­ cans. 168 therefore, ahps that are introduced in conjunction with hsas may provide america with its first piecemeal victory toward increasing access, qual­ ity, and affordability to america's working poor and small businesses. presi­ dent bush traveled one step closer in implementing these ahps and bringing health care to eight and half million americans after the successful passage of the small business health and fairness act of 2005 ("sbhf a") last july. 169 the sbhf a sets forth the rules governing ahps170 and the various participa­ tion and coverage requirements.111 despite the promise of ahps as a path to improving health care access, affordability, and cost for small businesses and their employees, critics still suggest that ahps will "destabilize the insurance market, leading to higher premiums for small businesses that do not join association health plans."172 some critics who disfavor the plan suggest that it will open the door to insur­ ance scams, and more importantly that ahps ''would be largely exempt from state regulation and would attract healthier workers, 'thereby increasing costs for firms that remain in the traditional insurance market. "'173 yet, in spite of this opposition surrounding ahps, there remains a great deal of support back­ ing their implementation.174 166 office of the press sec., america's ownership society: expanding opportunities (aug. 9, 2004), available at http://www.wbitehouse.gov/news/releases/2004/08/200408099.html. 167 george w. bush, president of the united states, remarks by the president in a con­ versation on health access (mar. 16, 2004), available at http://whitehouse.gov/news/releases /2004/03/20040316-5.html. president bush was careful, however, to instruct the audience that he was not suggesting ahps were a directional shift toward the government assuming health care regulation responsibility when he stated, " .•. the option, by the way, is not to say, the fed­ eral government ought to take it over, take over the health care industry. that would be the absolute wrong prescription. the right prescription is reasonable policy, one of which is associ­ ated health plans." ld. 168 u.s. chamber of commerce, just 1he facts: small business health plans (2006), available at http://www.uschamber.com/issues/indexlhealth/0306 _ abps _ facts.htm. 169 small business health & fairness act of2005, h.r. 525, 1 09th cong. (2005). 170 h.r. 525, § 801, 109th cong. (2005). 171 ld. §§ 804-807. 172 robert pear, bush prepares health plan aimed at small businesses, n.y. times, jan. 27, 2003, at a21. 173 robert pear, republicans shift focus to helping the uninsured, n.y. times, dec. 15, 2003, at a25. 174 see memorandum from senators olympia snowe, jim talent, john mccain, christo­ pher bond, norm coleman, kay hutchinson, elizabeth dole, & arlen specter, senators, to the united states senate, usa today supports association health plans (jan. 27, 2004), available at http://sbc.senate.gov/htmucolleaguelusatodayahpdearcolleague.pdf (suggesting that the 2007] hsas and small business: cost, quality, and access 317 in the context of segmented legislation attempting to remedy the health care crises small businesses and their employers are facing, the movement to­ ward adopting ahps may provide an immediate solution. allowing small busi­ ness to purchase insurance collectively will increase the bargaining power among small businesses and their employers and may help to effectuate an im­ mediate reduction in the costs of health care. once small businesses are able to increase their bargaining power through ahps by purchasing collective insur­ ance, the likelihood of increasing quality and access to health care through the implementation ofhsas appears to become more of a reality. vi. conclusion managed care leaves much to be desired with respect to the various costs and tactics used to corral the health care industry's excessive costs. hsas were thus created by president bush with the hopes of turning over to the market the task of creating competition, and in tum, lowering the costs of care to consum­ ers. specifically, hsas were aimed at lowering the cost to small businesses of providing health care benefits to their employees. hsas, however, present several problems when they are implemented in the context of small businesses. the nature ofhsas, principally the associated hdhps, makes it difficult for low-wage earning employees to accumulate funds for future medical expenses. legislation that mandates consumer education programs that shows consumers how to access, analyze, and apply health care information is a strong beginning toward allowing consumers to manage their own health care finances; however, it is an insufficient solution standing alone. organized consumer bargaining factions could help to increase purchasing power among small businesses by illustrating to the health care industry that there is a fraction of the population whose financial resources are not effec­ tively being utilized within the health care market. legislation calling for a complete government take over of the health care industry, such as the health security for all americans act, would likely pro­ vide an end-all solution to the problem, but such legislation is not likely to pass because incremental solutions seem to be a preferable solution among conattached usa today editorial accurately frames the debate surrounding ahps); letter from olympia snowe, senator, to william frist, senate majority leader (feb. 16, 2006), available at http://sbc.senate.gov/pd£1ahp-final-02-17-06.pdf(pressing for association health plans to reach the senate floor for a vote); olympia snowe, ahps are a matter of fairness, sept. 14, 2005, available at http://sbc.senate.gov/republican/pdf/sbhp-thehill..()p-ed.pdf( stating "[the proposed ahp legislation] unleashes the power of the competitive market to provide small businesses with more choices when it comes to securing affordable, quality insurance cover­ age."); rob kaiser, association health plans seek strong dose of support, chi. trib., feb. 10, 2003, at business pg. 1 (highlighting the recent momentum that ahps have been gaining); al­ bert b. crenshaw, small finns pushing to level health coverage playing field; benefits: business groups lobby for change in law to let them band together to buy coverage, l.a. times, feb. 28, 2001, at c7 (discussing small business owners' desire to purchase health cover­ age collectively). 318 indiana health law review [vol. 4:287 gress. the most promising solution addressing the needs of small businesses are ahps, which spread risk among many small business owners, allowing them to expand their business and employee base without worrying about the health care expenses associated with growth. regardless of how a solution is obtained, the bottom line is that there are currently too many hardworking americans and families who are not guaran­ teed access to quality health care. short of the united states government as­ suming the role of health care provider, it is difficult to envision equal access to health care for all americans becoming a reality in the near future. in theory, while hsas seem to provide an adequate solution to controlling costs and sub­ sequently increasing access, the fact remains that a segment of the population is effectively excluded by their implementation. congress and the president can continue an incremental approach to fixing the system, some of which may be successful in addressing the needs of small segments of the population, but without legislation creating a government run and universal health care system there is no guarantee that each american will be assured immediate access to health care. it is precisely this lack of a guarantee to health care that piecemeal approaches have been unsuccessful in remedying. glenn t. troyer glenn troyer is an attorney with the indianapolis-based law firm of krieg devault llp. mr. troyer received his b.a. from wittenberg university, springfield, ohio, in 1967, his m.h.a. from indiana university, indianapolis, indiana, in 1971, and his j.d. from capital university law school, columbus, ohio, in 1975. he is admitted to the bars of ohio and indiana. mr. troyer's main area of practice is in health care, with more than 28 years of experience in providing legal representation to hospitals, physicians, mental health centers, nursing facilities, and other healthcare providers in business trans­ actions, health law matters, and compliance-related issues. mr. troyer has written numerous articles and given numerous presentations on health law and risk management issues. he was a founding director and the third president of the american society of healthcare risk management (an affiliated professional society of the american hospital association) and now contributes to its publications. he has co-authored a corporate com­ pliance chapter in the fourth edition of that organization's risk management handbookforhealthcare organizations (2004). he also co-authored and co-edited the book entitled handbook ofhealthcare risk manage­ ment (1986). he is a past chair of the physician recruitment task force of the american academy ofhealthcare attorneys, now known as the american health lawyers association, which published the physician recruitment and retention guidebook (1997). he co-authored the st. christopher corporate compliance manual (1996), and the hipaa compliance manual (2001). he is an active member of the american health lawyers association and the health care compliance association. prior to entering private practice, he served in various administrative capacities in hospital settings in columbus, ohio; chicago, lllinois; and indianapolis, indiana, including five years as general counsel and director of risk management for methodist hospital of indiana, inc. david e. jose david jose is an attorney with the indianapolis-based law firm of krieg de vault llp. david jose concentrates his practice in health care, corporate, administrative, and regulatory law. he handles regulatory compliance and administrative appeals, contract review and negotiation, mergers and acquisi­ tions, and general commercial and corporate legal matters for for-profit and non-profit organizations, trade associations, and individuals. after graduating from earlham college with an a.b. in 1975 and the university of wisconsin with an m.a. in 1976, david jose attended boston college law school where he was the executive editor of the uniform commercial code reporter digest and graduated with honors in 1981. david has written articles and given presentations to civic, business, and pro­ fessional organizations on a variety of health care, business, and regulatory topics. in addition, david is the immediate past chair of the healthcare and medicine law section of the indiana state bar association. his professional associations and memberships include the indianapolis bar association, indiana state bar association, american bar association, and the american health lawyers association. andrea d. brashear andrea brashear is an attorney with the indianapolis-based law finn of krieg devault llp. she concentrates her practice in health care, corporate, regulatory, and administrative law, providing legal services to long tenn care facilities, hospitals, community mental health centers, health care practices, and individual health care professionals. her experience includes regulatory compliance, contract development and review, administrative litigation, and general business matters. she is a frequent speaker and author on health care topics, including hip aa, fraud and abuse, and medical records law. brashear graduated from indiana university school of lawindianapolis and received her undergraduate degree in chemistry from depauw university. while in law school, brashear served as an editor of the indiana international and comparative law review, and was the recipient of the henry b. blackwell award for her law review note. she also was recognized for her efforts in moot court, being named to the order of barristers and selected to participate in and coach various national moot court teams. brashear is admitted to the indiana bar and is a member of the indiana bar association, indianapolis bar association, and american bar association. she is also a member of executive women in health care. governance issues for nonprofit healthcare 0rganuationsandthelmpucationsofthe sarbanes-oxley act glenn t. troyer david e. jose andrea d. brashear* introducrion the topic of "corporate governance" has received attention during the past few years. this attention has increased recently due to high-profile corporate scandals that have received extensive and prolonged media coverage. as a result, officers, directors, and outside professional advisors are seeking ways to respond to the scrutiny of regulators, legislators, the general public, and constituency groups such as investors and investment analysts. many of these scandals have occurred in the for-profit, general business environment. however, beneath these high-profile events, there have been corollary legal activities in the nonprofit and tax-exempt arenas. these developments reflect a significant undercurrent of changes for healthcare organizations. the combination of these events is destined to provide dramatic inducement for healthcare organizations to evaluate and modify their organization and operations. at the same time, the passage of the american competitiveness and corporate accountability act of 2002, widely known as the sarbanes-oxley act ("soxa"), is an example of the legislative response to these "scandals" and corporate governance issues. soxa is also an opportunity for healthcare organizations to stay "ahead of the compliance curve" by adapting and "transposing" the legislation from the for-profit, publicly-traded corporate arena to the nonprofit sector. this article will briefly describe some of the recent corporate scandals and the lessons they may provide in the area of nonprofit healthcare gover­ nance. it will then describe various sources of guidance and standards, as well as enforcement activities, that are stimulating the evolution of corporate governance for nonprofit healthcare organizations. those stimuli arise out of traditional state and federal sources such as state corporate and licensing laws, federal tax and medicare certification statutes, and accreditation criteria. new stimuli are also rising from more active federal tax and healthcare regulatory efforts along with state attorney general initiatives. the article will then briefly analyze some specifics of soxa within this rapidly evolving * glenn troyer and david jose are partners, and andrea brashear is an associate in the healthcare practice group with the law finn of krieg devault u.p, which is based in indianapolis, indiana. the authors would like to thank brett j. henry, associate, and kelly j. green, law clerk, for their assistance in preparing this article. 180 indiana health law review [vol. 1:175 environment and evaluate some of the implications that it contains or suggests for healthcare organizations in the corporate governance legal arena. i. the impact of high profile, for-profit scandals the terms corporation and scandal have become so frequently inter­ twined in recent years that many individuals may believe that you cannot have one without the other. the publicity has been exacerbated by prominent individuals associated with the corporations, such as ken lay at enron, bernard ebbers at worldcom, martha stewart's relationship to imclone systems, richard grasso's compensation at the new york stock exchange, and many others. the media's personification of these scandals has conse­ quences in many directions. enron apparently took advantage of an accounting loophole that allowed the company to use gross value instead of net value when calculating profits from energy contracts. it then compounded the distortion by selling the same product repeatedly to sham partnerships created by enron executives. 1 worldcom created its own "loophole" by treating ongoing operating costs as capital investments, which resulted in lower annual operating expenses since they were spread into the future.2 in these and other situations, the perfor­ mance and independence of auditors have raised fundamental fiduciary business practice questions. those questions have also been turned upon the governing boards and their audit committees. this is one reason why soxa focuses so much attention on the independence of outside auditors as well as the composition and operation of board audit committees. with respect to the healthcare field, perhaps the highest profile "cor­ porate scandal" has been with healthsouth corp. ("healthsouth"). this company rapidly grew from the mid-1980s to become the largest united states provider of outpatient surgery, diagnostic imaging, and rehabilitation services, with almost 1,700 sites in all fifty states and abroad.3 healthsouth stands accused of significant accounting fraud and widespread abuse of medicare reimbursement regulations.4 the securities and exchange commission ("sec") has pursued enforcement actions, and the department of justice filed an eighty-five-count indictment against richard scrushy, the former ceo who has been portrayed as the mastermind of a multibillion-dollar scheme to defraud investors.5 at the time of the indictment, fourteen former health1. for a discussion of the various corporate scandals, the role of auditors, and the response of the sarbanes-oxley act, see ethan g. zelizer, the sarbanes-oxley act: accounting for corporate corruption?, 15 loy. consumer l. rev. 27 (2002). 2. !d. 3. j. reeves, health system replaces directors, phila. inquirer, dec. 3, 2003, at c03. 4. reed abelson & melt freudenheim, the scrushy mix: strict and so lenient, n.y. times, apr. 20, 2003, at ai. 5. melt freudenheim & eric uchtblan, former healthsouth chief indicted by u.s., n.y. times, nov. 5, 2003, at cl. 2004] healtiicare 0rgan1zations and the implications of soxa 181 south executives and accounting managers, including all five of its former chief financial officers, had already pleaded guilty to various fraud charges. 6 these cases have resulted in scrutiny beyond standard regulatory enforcement, shareholder lawsuits, and criminal charges. this is reflected by a lawsuit filed against healthsouth by the teachers retirement system of louisiana ("system"). 7 in its lawsuit, the system sought to change the way the company was governed rather than recover financi.allosses on its invest­ ments. pointing to a variety of corporate governance issues involving the board and several of its members, the system pursued the dismissal of five long-time board directors at a promptly-scheduled shareholders meeting. 8 drawing an analogy from recent military activity, a lawyer for the system stated, "regime change was desperately needed at healthsouth."9 the wall street journal devoted an entire supplement to current con­ cerns about governance and its relationship with corporate scandals.10 the twelve-page section included topics such as how to be a good director, the best method for selecting directors, and the degree of disclosure or ''transparency" that companies should provide. these recent developments carry significant implications for the governance of healthcare organizations, including the individuals who may believe they are simply performing community service on a governing board for a community hospital. for instance, the federal government is taking a position that the criminal law components for violation of soxa constitute a "lower intent" crime, heightening exposure for officers on boards who sign financial statements and independent members of board audit committees. 11 in addition, moody's investors service is considering extending governance ratings to nonprofit hospitals and health systems. 12 sage givans, a memberofhealthsouth' s audit committee, described the difficulties and challenges for a governing board in this new era in his testimony before the house energy and commerce committee's oversight and investigations subcommittee in november 2003: at healthsouth, we had numerous controls and systems in place that should have helped detect this fraud. unfortun­ ately, when high-level management conspires to commit a criminal act, i don 'tknow of any corporate governance policy that would prevent such behavior. how to prevent this type 6./d. 7. michael tomberlin, louisiana pension fund seeks to remove healthsouth board, birmingham news, sept. 10, 2003. 8. chris gautreau, pension plan forces healthsouth changes, batonrougeadvoc., dec. 3, 2003, at la. 9. reeves, supra note 3. 10. wail st. j., oct. 27,2003, atrl-12. 11. julie peotrowski, healthsouth's most wanted, mod. healthcare, nov. 10, 2003, at6. 12. mary chris jaldevic, rating adjustment, mod. healthcare, dec. 1, 2003, at 12. 182 indiana health law r.ev1ew [vol. 1:175 of fraud in the future is certainly a challenge for boards all across the countryy the lessons that these for-profit corporations, like healthsouth, have learned over recent years can be instructive for nonprofits and their boards. ii. historical context for nonprofit volunteer boards in order to achieve and maintain their tax-exempt status, nonprofit organizations must operate for the benefit of the public. one factor that can indicate an organization is operating for the good of the public is control by a board that is drawn from the comiilunity and that does not hold a direct economic interest in the organization.14 as a result, nonprofit boards have historically been composed of volunteers, who are often laypersons with respect to the operations of the organization that they govern. volunteer board members may have once believed that they were personally insulated from liability due to their ''volunteer" status, or that decisions made in their volunteer board member capacity could not expose their organization to liability. .however, evolving law and emerging principles of corporate responsibility indicate otherwise. in the mid-1960s, darling v. charleston community memorial hospi­ ta/15 represented a turning point for hospitals and their governing boards. in that case, the lllinois supreme court connected a hospital governing board's powers with a medical staff member's negligent actions in finding the hospital liable for negligent medical and hospital treatment. in affirming the appellate court's decision, the lllinois supreme court stated that a hospital's licensure regulations, accreditation standards, and bylaws, which delineate a governing board's responsibilities, collectively establish that it is "both desirable and feasible that a hospital assume certain responsibilities for the care of the patient."16 while courts have found hospitals liable based upon their board's actions or inactions, courts have been reluctant to extend liability to board members individually. this is in part due to "volunteer director" immunity state legislation that began to emerge over a decade ago. to date, at least seventeen states17 have enacted legislation to protect volunteer directors; 13. peotrowski., supra note 11. 14. brucer.hopkins, thei..awoftax-exemi'i'oroanjzations 137 (6tbed.1992). 15. darling v. charleston cmty. mem'l hosp., 211 n.e.2d 253 (lll. 1965). 16. /d. at257. 17. see cal. corp. code§ 5239 (west 2003); col rev. stat. ann.§ 13-21-115.7 (west 2003); conn. gen. st. ann. § 52-557m (west 2003); fl. stat. ann. § 617.0834 (west 2003); ind. code ann.§ 34-30-4-2 (west 2003); ky. rev. stat.§ 411.200 (banks-baldwin 2003);la.rev.stat.ann.§2792.1(west2003);me.rev.stat.ann.§158-a(west2003); md. code ann.§ 5-417 (2003);mont.codeann. § 27-1-732(2003);n.d. cent. code§ to33-47 (2003); neb. rev. st. § 25-21, 191 (2003); n.m. st. ann. § 53-8-25-3 (michie 2003); 2004] healthcare organizations and the lmpucations of soxa 183 however, many of these state statutes are narrow in scope. 13 in light of today' s corporate governance environment and considering the fact that many states either do not clothe volunteer directors with immunity or substantially limit the scope of such immunity, board members must be cognizant of exposure to liability from both a personal and global perspective. appreciating the scope of this exposure is conditioned upon an understanding of the state and federal authorities that shape nonprofit healthcare organizations. iii. state nonprofit corporate code a. standards for directors' duties some states have statutory law that specifically governs the corporate conduct of non profits. a few of these states' laws are based on the revised model nonprofit corporation act ("model act"). 19 the indiana nonprofit corporation act of 1991 ("indiana nonprofit act")20 is similar in many essential features to other state nonprofit corporation codes in the manner in which it regulates the activities of nonprofit corporations in indiana. the indiana nonprofit act mandates that a nonprofit corporation have a board of directors. 21 the articles of incorporation of a nonprofit corpora­ tion "may authorize a person or group of persons ... to exercise some or all of the powers that would otherwise be exercised by a board of directors."22 however, the non-director person or group of persons authorized to exercise those powers normally reserved for members of the board of directors must abide by the duties and responsibilities imposed on corporate directors. 23 the duties for directors of nonprofit corporations in indiana, and the standards for those duties, are set out in the indiana nonprofit act. in this respect, the indiana nonprofit act has followed the precedent set by the indiana business corporation law4 ("indiana corporation law") in its okla. stat. ann. tit. 18, § 866 (west 2003); s.d. codifled laws§ 47-23-32 (michie 2003); va. code ann.§ 8.01-220.1:4 (michie 2003); w.va. code§ 55-7c-3 (2003). 18. even though indiana code section 34-30-4-2 does provide limitation ofliability for directors, it does not protect the directors from incurring the cost of defense. 19. revised model nonprofit corporation act (1967) [hereinafter model act]. the model act represents, in essence, suggestions of the american bar association as to how state laws should be formulated. kevin m. boyle, nonprofit corporation act of 1991: introduction to significant changes, 35 res gestae 462,462 n.2 (1992). the model act has been adopted in some form by several states other than indiana, including alaska, georgia, montana, and oregon. /d. other states are considering adopting the model act as well. /d. 20. ind. code§ 23-17 (2004). 21. /d.§ 23-17-12-l(a). 22. 1d. § 23-17-12-l(c). 23. /d.§ 23-17-12-l(c)(l). 24. /d. § 23-1. 184 indiana health law review [vol. 1:175 adoption of statutory standards for directors of business corporations. 25 specifically, a nonprofit corporate director is required to discharge his or her duties, based on facts then known to him or her, "(1) (i]n good faith, (2) [ w ]ith the care an ordinarily prudent person in a like position would exercise under similar circumstances, [and] (3) [i]n a manner the director reasonably believes to be in the best interests of the corporation."26 · the indiana nonprofit act thus imposes both a duty of care and a duty of loyalty on a nonprofit director.27 traditionally, neglect, mismanagement, and improper (but disinterested) decision-making have been addressed under a board member's duty of care. separately, issues relating to fraud, self­ dealing, improper diversions of corporate assets, misappropriation of corporate opportunities, and other conflicts of interest have been raised under a board member's duty ofloyalty.28 while many states treat the duty of care as separate and distinct from the duty of loyalty, the indiana nonprofit act combines them. 29 in addition to the duties of care and loyalty, the indiana nonprofit act designates standards of conduct for a director of a nonprofit corporation. in discharging his or her duties of care and loyalty, a director is permitted to rely on information, opinions, reports, or statements, including financial statements and other financial data, prepared or presented by certain persons delineated by the statute in whom confidence by the director is justified. 30 nevertheless, a director is not acting in good faith if the director has knowledge concerning a matter in question that makes reliance-that would otherwise be statutorily permitted-unwarranted. 31 the provisions in the indiana nonprofit act that mandate the duties and standards of conduct for nonprofit directors contain language that is quite similar to that in the model act. 32 however, while both the indiana nonprofit act and the indiana corporation law require "willful misconduct or reckless­ ness" by a director in order for him or her to be held liable under indiana 25. paul j. galanti, business organizations, 20 ind. prac. series§ 53.10, 102 (supp. 2003). 26. ind. code§§ 23-17-13-1(a)(l)-(3) (2004). 27. "the duties of care and loyalty are the common tenns to describe the standards which guide all actions a director [or officer] takes. these standards are derived from a century oflitigation principally involving business corporations and are equally applicable to nonprofit corporations." harvey j. goldschmid, the fiduciary duties of nonprofit directors and officers: paradoxes, problems, and proposed reforms, 23 j. corp. l. 631,638 (1998). 28. !d. at 646. 29. david w. barrett, note, a call for more lenient director liability standards for small, charitable nonprofit corporations, 71ind. l.j. 967,986 (1996). 30. see ind. code§ 23-17-13-l(b) (2004). 31. id. § 23-17-13-1(c). 32. compare ind. code§§ 23-17-1 to -30 with model act, supra note 19. 2004] heal1hcare organjzations and 1he impucations of soxa 185 law ,33 the model act establishes a standard of "gross negligence" for liability of corporate directors. 34 · b. case law interpretation of fiduciary duties there is a dearth of case law addressing and interpreting the statutory duties of a direetor of a nonprofit corporation. under the common law, directors of indiana nonprofit corporations have a general duty of loyalty and must act in good faith. 35 in one instance, the indiana court of appeals, in kirtley v. mcclelland, 36 held that a director, despite a desire to support the organization, appropriated an opportunity belonging to the nonprofit unit owner's association, breaching his fiduciary duty of loyalty as a member of a board of a nonprofit organization.37 additionally, case law suggests that the suitable standard of care to be followed by directors of nonprofit corporations is "aligned with principles of corporate duty and not the strict 'prudent man' standard of trust law."38 the supreme court of louisiana, in mary v. lupm fouruiation,39 looked to a business corporation statute in interpreting a statutory provision concerning duties of directors of nonprofit corporations. 40 the louisiana statute required nonprofit directors to discharge their duties in good·faith, with the diligence, care, judgment, and skill that an ordinary prudent person in a like position would exercise under similar circumstances.41 recent comments by the chief justice of the delaware supreme court were an important reminder of the viability, but limitations, of the ''business judgment rule" for corporate directors. chief justice veasey provided some relief by commenting that this protective ''rule" is "alive and well," but also noted that directors have a proactive oversight role under delaware corporate law. fiduciary duties are met by processes that demonstrate a board or 33. /d.§§ 23-17-13-1(d), 23-1-35-l(e). 34. see model acr, supra note 19, at § 8.30. the model act solely provides that "[a] director is not acting in good faith if the director bas knowledge concerning the matter in question that makes reliance permitted by subsection (b) unwammted," and does not have the explicit"willfulmisconductorrecklessness"ianguagefoundinlndianacodesection23-17-13l(d)(2). id.; see also barrett, supra note 29, at 990. 35. galanti, supra note 25, at 102. 36. kirtley v. mcclelland, 562 n.e.2d 27 (ind. ct. app. 1990). 37. id. at 36. 38. galanti, supra note 25, at 103 (citing stem v. lucy webb hayes nat'l training scb. for deaconesses & missionaries, 381 f. supp. 1003 (d.d.c. 1974) and oberly v. kirby, 592 a.2d 445 (del. 1991)). 39. mary v. lupin found., 609 so. 2d 184 (la. 1992). 40. ld. at 187. "provisions relating to nonprofit corporations have been conformed generally to those relating to business corporations." id. 41. ld.; la. rev. stat. ann. § 12:226(a) (west 1994). 186 indiana health law revmw [vol. 1:175 corrunittee is operating in good faith and being proactive and inquisitive.42 this is an interpretation that would be equally applicable to directors of nonprofit corporations. c. state licensure and county hospital statutes most healthcare organizations are licensed by the state in which they operate. state licensure laws for hospitals43 set forth the governing board's legal responsibilities and discretionary powers, while naming the board as the supreme authority of the hospital. fudiana' s hospital licensure statute makes the board generally responsible for the management, operation, and control of the hospital. 44 fudiana' s hospital licensure statute and regulations45 expressly hold the board responsible for specific issues related to the medical staff and bylaws,46 management,47 patient care,48 the institutional plan and 42. alison carpenter & susan webster, corporate governance.: business judgment rule still alive, delaware's veasey tells directors' group, 12 health l. rep. (bna) 1645 (oct. 30, 2003). 43. hospitals are the typical focus for discussions of nonprofit healthcare organizations. however, other healthcare organizations may obtain nonprofit status as well. a few examples include conununity mental health centers, nursing facilities, rehabilitation centers, and residential facilities. 44. ind. code§ 16-21-2-5 (2004). 45. see generally id. §§ 16-21-2-5 to -15; ind. admin. code tit. 410, r. 15-1.4 (2004). 46. under indiana law, the governing board's responsibilities with respect to the medical staff include the following: (a) "ensure the medical staff has approved bylaws and rules and that they are reviewed and approved at least triennially." ind. admin. code tit. 410, r. 15-1.4-l(a)(3)-(4),(b)(4); (b) "assume responsibility of appointment, reappointment, and assignment of privileges to medical staff members." ind. code§ 16-21-2-5; (c) "ensure that the medical staff is accountable and responsible to the board for the quality of care provided to patients." ind. admin. code tit. 410, r. 15-1.4-l(a); (d) "maintain a liaison with the medical staff." /d. r. 15-1.4-1; and (e) "ensure that the criteria for selection for medical staff membership are individual character, competence, education, training, experience, and judgment." id. 47. under indiana law, the governing board must, among a variety of duties relating to management, (a) appoint a chief executive officer ("ceo"), (b) develop in writing, responsibilities and authority of the ceo, (c) require the ceo to develop policies and programs in a variety of areas, and (d) require the ceo (or designee) to attend board and committee meetings and act as the board's representative at medical staff meetings. ind. admin. code tit. 410, r. 15-1.4-l(c). 48. under indiana law, the governing board must (a) "ensure all patients are admitted to the hospital only by a licensed practitioner who has been granted admitting privileges;" (b) ensure a qualified licensed physician who is a member of the medical staff is responsible for the care and treatment of each problem present at admission or that develops during hospitalization; (c) make sure that the hospital provides required emergency care services; (d) ensure that policies are developed to cover impaired physician limited practice problems; and (e) ensure the hospital has certain policies on organ and tissue donation. id. r. 15-1.4-l(d). 2004] healthcare organizations and the impucations of soxa 187 budget,49 and contracts. 50 a governing board may have to be attentive to other licensing restric­ tions. for instance, in order to qualify as a ••county hospital" in indiana, a hospital must meet various statutory and regulatory requirements, which delineate unique responsibilities of a county hospital's governing board. 51 in addition to such state licensing requirements, governing boards must also adhere to a variety of federal authorities, including, among many, those relating to medicare certification and participation and the requirements of the internal revenue service ("irs") for tax-exempt status, as discussed below. iv. fbl>eral au'ihorities a. conditions of participation in order to participate in the medicare and medicaid programs, healthcare organizations must meet and maintain compliance with specific requirements established by the centers for medicare and medicaid services e·cms") of the united states department of health and human services. these requirements, known as conditions of participation, vary depending upon the type of healthcare organization. the conditions of participation for hospitals require a hospital to have an effective governing body that is legally responsible for the conduct of the hospital as an institution. 52 cms has promulgated six general standards that 49. under indiana law, the governing board must {a) oversee the preparation of the institutional plan, which shall include, but not be limited to, the programs and services provided and an annual operating budget prepared in accordance with generally accepted accounting principles; and (b) ensure the plan is reviewed and updated annually. ld. r. 15-1.4-l(e). so. underbidianalaw,thegovemingboardmust(a)ensurethatanycontractorproviding services does so as to ensure that the hospital is compliant with all applicable laws; (b) ensure that all contracted services are performed in a safe and effective manner and are included in the hospital's quality assessment and improvement program; and (c) ensure that the hospital maintains a list of all contracted services, including the scope and nature of the services. ld. r 15-1.4-l(f). 51. see generally ind. code§§ 16-22-3-1 to -30. in indiana, the county hospital statute places various responsibilities upon the board relating generally to the following: (a) the medical staff and bylaws; (b) management requirements; (c) financial matters; (d) patient care; (e) the hospital's budget; and (f) contracts. ld. 52. 42 c.p.r. § 482.12 (2004). aside from the condition of participation addressing the governing body of a hospital, there are several other conditions that must be satisfied for a hospital to participate in medicare. ld. the conditions for participation that relate to administration are specifically titled compliance with federal. state. and local laws(§ 482.11) and patient's rights(§ 482.13). those conditions for participation relating to basic hospital functions include: quality assessment(§ 482.21); medical staff(§ 482.22); nursing services (§ 482.23); medical record services (§ 482.24);.pharmaceutical services(§ 482.25); radiologic services (§ 482.26); laboratory services (§ 482.27); food and dietetic services (§ 482.28); utilization review(§ 482.30); physical environment(§ 482.41); infection control(§ 482.42); discharge planning (§ 482.43); and organ, tissue, and eye procurement (§ 482.45). the 188 indiana health law review [vol. 1:175 regulate the way a board must govern a hospital. the standards extend broad­ ly to the following areas of operation: (i) medical stafr,s3 (ii) chief executive officer,54 (iii) care of patients,55 (iv) institutional plan and budget,56 (v) contracted services,57 and (vi) emergency services.58 cms has published interpretative guidelines with respect to the conditions of participation to assist hospitals with their corporate compliance and corporate governance initiatives.59 b. accreditation requirements many hospitals utilize independent accreditation organizations for marketing and managed care contracting purposes. another benefit of the accreditation process is that it may substitute for cms' s survey and certifica­ tion process through a process known as "deeming." cms has recognized conditions of participation relating to optional hospital services include: surgical services (§ 482.51); anesthesia services (§ 482.52); nuclear medicine services (§ 482.53); outpatient services(§ 482.54); emergency services(§ 482.55); rehabilitation services(§ 482.56); and respiratory care services (§ 482.57). there are additional conditions of participation for specialty hospitals. see 42 c.f.r. pt. 482, subpt. e. 53. a hospital governing board must (a) assure the approval of the medical staffs bylaws; (b) appoint members of the medical staff after considering recommendations of the existing members; (c) ensure that the medical staff is accountable to the board for quality of care; and (d) establish categories of practitioners and ensure that the members of the medical staff are selected based upon the individual character, competence, training, experience, and judgment. 42 c.f.r. § 482.12(a). 54. a hospital governing "board must appoint a chief executive officer who is responsible for managing the hospital." ld. § 482.12(b ). 55. a hospital governing board must (a) ensure there are hospital policies that provide for patients to be under the care of an appropriate professional staff following admission; and (b) ensure an appropriate physician is on duty or on call at all times. ld. § 482.12(c). 56. a hospital governing board must have an overall institutional plan with an annual operating budget prepared in accordance with general accepted accounting principles that includes all anticipated income and expenses. ld. §§ 482.12(d)(l)-(2). the plan must provide for capital expenditures for at least a three-year period. ld. § 482.12(d)(3). the plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of six hundred thousand dollars ($600,000). ld. § 482.12(d)(4). 57. a hospital "governing board must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation." 42 c.f.r. § 482.12(e). 58. if emergency services are provided, a hospital governing board must (a) ensure that emergency services are organized under the direction of a qualified member of the medical staff and integrated with other departments of the hospital and (b) ensure there are adequate medical and nursing personnel qualified in emergency care to meet procedures established for the hospital and the needs anticipated by the hospital. ld. §§ 482.12(1), 482.55. 59. ctr.s. for medicare & medicaid servs., hospitals interpretive guidelines and survey procedures, at http://www.crns.hhs.gov/manuals/pub07pdf/ap-a.pdf (last visited feb. 25, 2004). 2004] healthcare organjzations and the impucations of soxa 189 certain national accrediting bodies as "deemed organizations."60 because of the deemed organizations' high standards, cms has granted them "deeming authority" to review hospitals for certification in addition to accreditation.61 hospitals which meet an appropriate deeming authority's high standards are granted "deemed status" and become exempt from the cms survey and certifi­ cation process so long as they maintain this status. 62 a primary accrediting organization for hospitals is the joint commission on accreditation of health­ care organizations ("jcah0").63 jcaho has identified specific standards and elements of performance that are applicable to how a board shall govern a hospital. 64 c. irs pronouncements a healthcare provider may qualify for tax-exempt status under internal revenue code § 501(c)(3) if it is organized and operated exclusively for charitable purposes. 65 in order to fulfill this charitable purpose requirement, the healthcare provider must operate to meet the community benefit stand­ ard. 66 this is the starting point for a governing board to appreciate some of the outside "constituencies" being served as a quid pro quo for the organi­ zation's tax-exempt status. according to the governing regulations, the organization must be engaged ''primarily in activities which accomplish one 60. crrs.r>rmedicare&medicaidservs., conditions ofparticipation (may 3, 2002), at http://www.cms.hhs.gov/cop/. 61. 42 c.f.r. § 488.5 (2004); see also joint comm'n on accreditation of health­ care 0rgs., federal deemed status and state recognition (sept. 2002), at http://www.jcaho .orglabout+uslgovernment+relationslfed_st_rec.htm. 62. id. 63. another accrediting organization that has "deeming authority" is health facilities accreditation program, which is couunonly known as ''hfap." am. osteopathic ass'n, about healthcare facilities accreditation program (2003), at http://www.aoa-net.org/ accreditationihfap/about.htm. 64. the presentjcaho standards :require a hospital governing board to perform a variety of specific and general functions, including (i) define governance responsibilities in writing, (ii) provide for organizational management and planning, (iii) demonstrate a commitment to the organization's community, (iv) define the qualifications and competence for the medical staff and provide adequate resources for the care and services provided, and (v) annually evaluate performance in relation to the organization's vision, missions, and goods. joint comm'n on accreditation of healthcare 0rgs., comprehensive accreditation manual for hospitals: the official handbook (2004). it is interesting to note that the recent jcaho standards blur some of the distinction between an organization's board of directors and its management under the topic of "leadership" standards. 65. i.r.c. § 501(c)(3) (2003). 66. rev.rul.69-545, 1969-2c.b.l17 (describingthecommunitybenefitstandard). for a discussion of the issues and steps for healthcare organizations applying for tax-exempt status, seejanete. oitterman & marvinfriedlander.health care provider reference guide, available at www.irs.gov/publirs-tegeleotopicc04.pdf (last visited feb. 24, 2004). 190 indiana health law review [vol. 1:175 or more of its exempt purposes ... [with no] more than an insubstantial part of its activities ... not in furtherance of an exempt purpose."67 the concept of "community benefit" may vary with the type of healthcare organization. for hospitals, the focus of attention will be on the people within the community being served, nondiscriminatory treatment of medicare and medicaid patients, the extent of charity care provided, and the availability of an emergency room without regard for a person's ability to pay.6s beyond serving the public constituency, a governing board of a tax­ exempt organization must at the same time protect against activities that result in "private inurement" and "private benefit." the restriction against "private inurement" is a strict prohibition against any part of the organization's net earnings inuring in whole or in part to the benefit of any "private shareholder or individual." in practice, since nonprofit corporations do not have share­ holders, the target for this prohibition is generally referred to as "insiders"­ individuals with an interest in or opportunity to influence the activities of the organization.69 violation of the prohibition against private inurement results in a loss of tax -exempt status. therefore, a governing board must be attentive to this concept and the severe consequences of the strict liability exposure. a second prohibited activity relates to "private benefit." the targeted area of potential beneficiaries extends beyond "insiders," but a violation does not necessarily result in loss of tax-exempt status. any "private benefit" must be both qualitatively and quantitatively incidental compared to the public benefit and charitable purpose otherwise being served.70 while many of the recent corporate scandals have involved excessive benefits for corporate insiders, the concept of "private benefit" for tax-exempt governing boards requires that attention be given to benefits provided for non-insiders. an organization and its management may often have an "explanation" for such "private benefits," and the governing board's duty requires a "peripheral vision" and inquisitiveness to determine the degree to which such benefits are appropriate and insubstantial. internal revenue code § 4958 was enacted as part of the taxpayer bill of rights 271 imposing "intermediate sanctions" short of tax exemption revocation on certain "excess benefit transactions" between the organization 67. treas. reg.§ 1.501(c)(3)-l(c) (as amended in 1990). 68. a good review of the basic principles discussed in this section was provided by t.j. sullivan, tax law update, presentation at american health lawyers association annual meeting (june 29-july 2, 2003). for a description of the factors evaluated in detennining a "conununity benefit" for a hospital, see rev. rul. 69-545, 1969-2 c.b. 117. 69. see sullivan, supra note 68, at 2; see also gittennan & friedlander, supra note 66, at4. 70. gen. couns. mem. 37,789 (dec. 18, 1978). 71. taxpayer bill of rights 2, pub. l. no. 104-168, § 1311, 110 stat. 1452 (1996). 2004] healthcare organizations and the implications of soxa 191 and "disqualified persons. "72 final regulations were issued by the irs in 2002.73 this is a tool for heightened regulatory enforcement, allowing the irs to avoid the "death penalty" of losing tax-exempt status, presented by the strict prohibition on private inurement. as a result, governing boards will now face increased scrutiny in this area. 74 briefly, this statute imposes a significant excise tax on the value of excess benefits the organization provides to a "disqualified person,"75 with a very steep tax if not promptly corrected. targeted transactions include ones in which the disqualified person pays less than fair-market value for a good or service, receives unreasonable compensa­ tion, or where there is inappropriate "revenue sharing."76 while the threat of intermediate sanctions hangs over an organization's management and governing board, the irs has provided some guidance for compliance. in this era of internal investigation and self-reporting encouraged by corporate compliance activity, the irs has announced a desire to solicit comments on the scope and content for voluntary compliance program guidance. 77 more immediately, the regulations issued by the irs provide a "rebuttable presumption" procedure to establish the reasonableness of compensation transactions. 78 the governing board is brought directly into the process, and is required to approve the transaction based upon appropriate data as to comparability, while documenting the basis for its determination.79 the irs has also provided encouragement through published guidance in the area of conflicts of interest. in 1997, the irs developed a conflicts of interest policy for tax-exempt organizations that can help illuminate and avoid potential private inurement, private benefit, and intermediate sanctions violations.80 the irs focuses its attention on "interested persons," which 72. see sullivan, supra note 68, at 4-8; see also gitterman & friedlander, supra note 66, at 5-6. 73. excise taxes on excess benefit transactions, 67 fed. reg. 3076 (jan. 23, 2002) (codified at treas. reg.§§ 53.4958-1 to 53.4958-8 (2004)). 7 4. for an extensive discussion of this topic and its application for healthcare providers, see the presentation by gerald m. griffith, dealing with excess benefit: the new tax compliance challenge, presented at the hospitals and health systems law institute, american health lawyers association (feb. 6-7, 2003). 75. "disqualified persons" are persons in a position, whether by organizational title or other means, to exercise substantial influence over the organization. see sullivan, supra note 68, at 5; see also gitterman & friedlander, supra note 66, at 6. 76. see sullivan, supra note 68, at 4. 77. announcement 2001-14, 2001-1 c.b. 648 (2001); see also griffith, supra note 74, at22. 78. treas. reg.§§ 53.4958-l(d)(4)(iv), -6(b) (2004); see griffith, supra note 74, ats-16; stephen t. miller, rebuttable presumption procedure is key to easy intermediate sanctions compliance, taxnotestoday92-63 (may 11, 2001). 79. see sullivan, supra note 68, at 8. 80. see lawrence m. brauer & charles f. kaiser, tax exempt organizations community board and conflicts of interest policy, presented at the irs exempt organizations continuing professional education technical instruction program for fiscal year 1997 (updated in 2000), available at http://www.irs.gov/pub/irs-tege!topic-c.pdf (last visited apr. 5, 2004). 192 indiana health law review [vol. 1:175 includes a trustee or director, a principal officer, or a member of a committee with board-delegated powers who has a direct or indirect financial interest in the organization. 81 adoption of the conflicts of interest policy is only the first step for the governing board. the board must then develop a process for evaluating disclosures and a procedure to deal with conflicts. the procedures should include minutes of meetings that reflect the board's understanding and application of the policy and its relationship to the organization's charitable purpose.82 v. reviewofrecentstateati'orneygenerallnitiatives as questions about "corporate governance" escalate in the for-profit arena, state attorneys general are taking a closer look at the way in which non­ profit boards govern their organizations. they are initiating investigations, filing lawsuits, and lobbying for legislation to safeguard the interest of the communities that nonprofits serve. this activity will directly or indirectly affect governance issues for nonprofit organizations in every state. a. minnesota: allina health system and management excesses minnesota's attorney gene~ mike hatch, initiated an investigation against his state's largest healthcare system, allina health system ("allina"), in 2001. subsequent to the investigation, hatch raised various issues with respect to how allina and its hmo, medica, both nonprofit companies, managed certain funds. specifically, hatch claimed that as much as forty­ seven percent of the health insurance premiums paid to medica were spent on allina's administration rather than on medical care for its members.83 this greatly exceeded the ten percent that medica had reported. 84 hatch pointed to specific expenditures to support his allegations. examples included expensive outings for medica employees, lavish company parties, questionable executive compensation, and hefty consultant fees. 85 while hatch acknowledged that these administrative costs and "perks" were not necessarily illegal, he stated that they do raise questions of possible mismanagement. 86 consequently, he filed a lawsuit against allina. 81. a sample conflict of interest policy ("sample policy") recommended by the irs is included in brauer & kaiser, supra note 80, at 25 and gitterman & friedlander, supra note 66, at30. 82. see the sample policy discussed, supra note 81. 83. attorney general files suitagainstallina, minneapousstar trib., mar. 22,2001, available at http://thenationalcoalition.org/suitagainstailina.htm [hereinafter attorney general]. 84. /d. 85. /d. 86. /d. 2004] healthcare organizations and the impucations of soxa 193 allina settled the lawsuit with the attorney general at the end of 2001. as a result, the parties entered into a memorandum of understanding, which placed certain restrictions on expenses, executive compensation, third party contracts, relations with affiliates, and the interaction between the allina and medica management.87 hatch's efforts to protect the community did not end with allina. as he also initiated investigations against two other large health plans: healthpartners and blue cross and blue shield of minnesota. 88 he also issued a memorandum on ''corporate responsibility," which is directed to both for-profits and nonprofits, urging political leaders to take "aggressive action to stop the hemorrhaging of our corporate institutions and financial markets."89 b. north dakota: banner health system and community assets in 2002, north dakota's attorney general, wayne stenehjem, filed a lawsuit against banner health system ("banner''), a charitable nonprofit organization authorized to do business in north dakota. 90 banner had operated five nursing homes in north dakota, which it sold in 2001.91 the litigation centered around banner's removal of certain assets, including the funds from the sale of these facilities, from north dakota for use in other states. the attorney general maintained that this money belonged to the north dakota communities in which the nursing homes had operated. 92 throughout the litigation, the attorney general argued that banner, as a nonprofit organization, was required to hold these proceeds and contri­ butions in a constructive trust for the benefit of the community these entities had served.93 however, the district court dismissed the case, stating that the attorney general had failed to allege facts to satisfy the elements necessary to impose a constructive trust.94 the attorney general appealed the district court's decision. the attorney general's appeal, as well as litigation initiated by banner in federal court, remained open until recently, when the parties 87. memorandum of understanding between allina and the minnesota office of the attorney general, at http://www.ag.state.mn.us/consumer/pdf/allina/memunder.pdf (last visited feb. 25, 2004). 88. attorney general, supra note 83. 89. office of minn. ati'y gen. mike hatch, corporate responsibility, at http://www.ag.state.mn.uslpdf/corporate_responsibiities_report.pdf (last visited feb. 25, 2004). 90. banner health system, north dakota ag settle claims over charitable assets, 12 health l. rep. (bna) 1903 (dec. 18, 2003) [hereinafter banner health system]. 91. /d. 92. /d. 93. see banner health sys. v. stenebjem, no. a3-02-121, 2003 u.s. dist. lexis 2702, at *2 (d.n.d. feb. 25, 2003). 94. /d. 194 indiana health law review [vol. 1:175 agreed to settle for one million dollars, contingent upon both parties dismiss­ ing all pending litigation.95 c. new hampshire: community benefits statute various states have enacted community benefits legislation that requires nonprofit hospitals to publicly disclose what community benefits and services they are providing in exchange for their tax-exempt status.96 many states97 with this type of legislation require the nonprofit hospital to annually file a report with the state attorney general's office or the state department of health regarding the level of benefit the nonprofit provides to the community it serves.98 new hampshire's community benefits statute (n.h. rev. stat. ann. §§ 7:32-c to 7:32-1 (1999)) is the most extensive in scope, extending not only to nonprofit hospitals but also to ''healthcare charitable trusts," including community health centers and visiting nurses associations. 99 the framework of the new hampshire legislation is structured around three themes: (1) public accountability, (2) community involvement, and (3) collaboration among charitable entities.100 the notion of public accountability is addressed in the legislation by placing a reporting duty upon§ 501(c)(3) entities, requiring them to file an annual community benefits report with the attorney general.101 since the effective date of the legislation, the new hampshire attorney general has been reviewing these reports in an attempt to provide nonprofits with ''best practices. "102 . the community involvement element requires the nonprofit hospital to obtain community input in determining the community's needs.103 this in95. see banner health system, supra note 90, at 1903. utigation involving the sale of banner assets in south dakota and issues similar to those raised in the north dakota litigation is still pending in both south dakota state and federal courts. id. 96. michael w.peregrine&jamesr. schwartz, theappucationofnonprofit corporation law to healthcare organizations 53 (am. health lawyers ass'n 2002). 97. the states that have this type of public disclosure requirement include california, georgia, idaho, indiana, minnesota, new hampshire, new yolk, pennsylvania, and utah. see id. 98./d. 99. id. at 53-54. 100. see office of health planning & medicaid, n.h. dep't of health & human servs., telling our story: new hampshire's community benefits report 2 (2002) [hereinafter telling our story], available at http://www.dhhs.nh.gov/dhhsihpr/library/ research/community-benefits.htm. 101. see n.h. dep't of justice, guidelines for preparation of the community benefits plan pursuant to rsa 7:32-e [hereinafterguideijnes], available at http://www. doj.nh.gov/publications/combenguide.btml (last visited may 20, 2004). 102. see telling our story, supra note 100. 103. see guidelines, supra note 101. 2004] healthcare organizations and the impucations of soxa 195 volves seeking assistance from public officials and the community-at-large. 104 specifically, this requirement has prompted new hampshire healthcare entities to hold public forums, organize focus groups, and survey the public in order to identify the community's needs and determine how best to respond to them. 105 moreover, the statute also encourages collaboration among healthcare charitable trusts in the preparation of community need assessments.106 while new hampshire's legislation does not mandate such collaboration, it strongly suggests it in order to minimize duplication of efforts and control costs. 107 d. indiana: conner prairie and donor's intent earlham college ("earlham") was made the trustee of a public charit­ able trust, established by eli lilly (''lilly") for the purpose of creating and operating an indiana history museum, now known as conner prairie. in 2003, the president of earlham, as the controlling member of the nonprofit corpora­ tion, fired all of the non-earlham affiliated board members of the nonprofit corporation created to oversee the museum's affairs.108 earlham's action led to a dispute between the dismissed former board members, now operating as a nonprofit organization named "save the prairie," and the college. prior to the mass dismissal, the board had been working with earlham to determine whether the museum could be completely separated from earlham and how to divide up various gifts from lilly that were given to earlham for the benefit of earlham and conner prairie.109 the negotiations apparently broke down when the museum board rejected earlham's interpreta­ tion of lilly's intent regarding the extent of the funds that should be allocated to earlham rather than conner prairie. 110 ultimately, the save the prairie group sought assistance from indiana attorney general, steve carter, claiming that earlham improperly shifted about $30 million to itself that was donated by lilly and intended for conner prairie. 111 the attorney general initiated his investigation in june 2003 and 104. jd. 105. id. 106. jd. 107. jd. 108. see save the prairie, inc., save the prairre, at http://www.savetheprairie.org/ filesfmdex.pdf (last visited feb. 22. 2004); see also earlham college, earlham resumes management of conner prairie (june 11, 2003), at http://www.earlham.edu/-publicaf/ connerprairie061103.html. 109. mary sell, prairie issue revolves around $130 million, pailadwm-itbm (july 2, 2003), available at http://www.pal-item.comlnews/stories/20030702/localnews/582000.html [hereinafter prairie issue]. 110. jd. 111. wishtvs, attorney general to investigate conner prairie dispute (june 24, 2003), at http://www. wishtv.comlgloballstory .asp?s=l334287&client1'ype=printable. 196 indiana health law review [vol. 1:175 is continuing to review whether or not charitable donations given to earlham were being used as intended by lilly. 112 e. maryland: carefirst and conflict of interest in 2001, carefirst, formerly known as maryland blue cross/blue shield company, announced its intention to convert from a nonprofit insurer to for­ profit status. 113 as a result of carefirst's announcement, maryland attorney general, joseph curran, jr., announced his interest in carefirst's proposal. 114 he stated that the issue was not only whether to allow the conversion, but also whether, as a nonprofit, carefirst should be forced to alter its conduct to conform with that expected of a nonprofit entity .115 one of curran's concerns regarding the conversion centered around carefirst' s disclosure of its proposed compensation packages for its execu­ tives, which collectively equaled $42 million dollars.116 curran feared that the insiders who negotiated would be well compensated, while marylanders and the maryland healthcare system would be left behind.117 after reviewing an opinion by the maryland attorney general118 and carefirst' s application for the conversion, the maryland insurance admin­ istration ("mia") rejected carefirst' s proposed conversion because it was not in the public interest as required by maryland law.l19 at the same time, curran continued to express concerns overprotecting the charitable assets and the public.120 subsequent to mia's decision to reject caref'rrst's conversion 112. ld. 113. officeofmd. ati'ygen.j.josephcurran,jr.,newsrelease,attomeygeneral takes issue with conversion, urges marylanders to read abell foundation report (dec. 3, 2001 ), at http://wwww.oag.state.md.us/press/200111203d01.htm [hereinafter conversion]. 114. see id. 115. see id. the abell foundation report criticized carefll'st for significantly changing its purpose and focus. id. careftrst formerly functioned as an insurer for high-risk individuals. i d. however, it took steps to eliminate coverage for the under-insured portion of the population, except through an expensive open enrollment program offered only twice a year. id. the state subsidized this program, leading to net earnings for the company. conversion, supra note 113. this was in addition to the significant reserves that carefirst also carried, which were above industry standards. id. 116. office of md. ati'y gen. j.josephcurran, jr., curran responds to disclosure of compensation packages for carefirst execs (mar. 7, 2002), at http://www.oag.state. md.us/press/2002/030702.htm. 117. ld. 118. see generally 87 op. md. att'y gen. 02-019 (2002) (opinion that the maryland insurance commissioner had the authority to review certain transactions associated with the proposed merger and conversion of carefirst to for-profit status). 119. see md. ati'y gen. report 2003-02-032 (2003) [hereinafter report]. see also office of md. ati'y gen., attorney general applauds process, commissioner's decision in proposed carefirst sale (mar. 5, 2003), athttp://www.oag.state.md.us/press/2003/030503 .htm [hereinafter commissioner's decision]. 120. see commissioner's decision, supra note 119. 2004] healthcare organizations and the implications of soxa 197 proposal, the attorney general testified during the 2003 legislative session. his testimony focused on his support of substantive changes to maryland law in order to address the threat to the public interest posed by carefirst' s questionable management practices. 121 the changes were enacted into law as a part of the emergency nonprofit health service plan reform legislation.122 vi. the recent arrival of "corporate compliance" during the past twenty-five years, healthcare providers, both institu­ tional and individual, have become more interested in and educated about the regulatory environment in which they conduct business or practice. this stems from external enforcement pressures exerted on healthcare providers to conform their business practices to a variety of state and federal regulations or face significant criminal and civil penalties. well-publicized cases involv­ ing violations of the anti-kickback statute are examples of such enforcement activities that assisted in getting both the healthcare providers' and the public's attention. 123 the high profile pressure facing today' s healthcare providers has been largely instigated by the federal and state fraud and abuse laws created in the last quarter of the twentieth century. these laws have been used by a variety of federal and state enforcement agencies to prohibit illegal activities, recover substantial overpayments, and assess fines and penalties. these federal statutes include the anti-kickback statute, 124 the false oaims act, 125 the stark law/26 the civil monetary provisions of various laws,l27 the federal healthcare program exclusion provisions, and healthcare fraud statutes affect­ ing governmental and nongovernmental third-party payors.128 many states have also enacted fraud and abuse statutes designed to address varying public policy considerations. these statutes often follow not only the federal anti-kickback and false oaims statutes, but also the physician self-referral prohibitions found in the stark law. additionally, prohibitions against fee-splitting and deceptive trade practices,· along with consumer protection statutes and professional licensing statutes, have been designed and interpreted to protect the public from fraudulent, abusive, and unprofessional conduct. 121. report, supra note 119. 122. id. 123. see, e.g., united states v. greber, 760 f.2d 68 (3d cir. 1985); united states v. kats, 871 f.2d 105 (9th cir. 1989); united states v. bay state ambulance & hosp. rental serv ., 874 f.2d 20 (1st cir. 1989). 124. 42 u.s.c. § 1320a-7b(b) (2004). 125. 31 u.s.c. § 3729 (2004). 126. 42 u.s.c. § 1395nn (2004). 127. id. § 1320a-7a 128. 18 u.s.c. §§ 1035, 1345 (2004). 198 indiana health law review [vol. 1:175 congress and the department of health and human services ("hhs") have attempted to provide direction and encouragement in conjunction with the multiple sources for penalties and prosecution. in 1987, congress directed the secretary of hhs to promulgate "safe harbor" regulations that would describe the business practices and relationships, regardless of the provider's state of mind, which would be free from prosecution. 129 the safe harbors 130 that have been developed and proposed131 have emphasized the importance and benefit of caution and compliance in structuring transactions and relation­ ships. additionally, since 1998, the office of inspector general ("oig") of hhs has developed eleven different compliance program guidance documents in order to assist those providers with development of compliance programs oriented toward the fraud and abuse laws.132 further, the oig provides direc­ tion annually through the publication of its "work plan,"133 identifying the types of enforcement activities that it intends to pursue in the coming year, organized by types of providers. for healthcare providers, this work plan can be useful in identifying high-risk compliance problem areas, which should be incorporated into the provider's compliance program for review and manage­ ment.i34 a major impetus for healthcare providers to develop compliance programs began on november 1, 1991, with the publication of the united states sentencing guidelines for organizations involved in federal criminal violations.135 a crucial component of the federal sentencing guidelines is the recognition of sentencing credit for organizations that utilize an "effective 129. 42 u.s.c § 1320a-7b(b)(3). 130. the safe harbors are located at 42 c.f.r. § 1001.952 (2004). 131. to date, the secretary of hhs through its office of inspector general has promul­ gated twenty-four safe harbors under the anti-kickback statute to guide the myriad of health­ care providers contracting with the federal and state governments under the medicare and medicaid and tricare programs. 132. the compliance plans address the following healthcare organizations: hospitals (63 fed. reg. 8987 (feb. 23,1998)); homehealthagencies(63fed. reg. 42,410(aug. 7, 1998)); clinical laboratories (63 fed. reg. 163 (aug. 24, 1998)); third-party medical billing com­ panies (63 fed. reg. 70,138 (dec. 18, 1998)); durable medical equipment suppliers ( 64 fed. reg. 36,368 (july 6, 1999)); hospices (64 fed. reg. 54,031 (oct. 5, 1999)); medicare +choice organizations (64fed. reg. 61,893 (nov. 15, 1999));nursingfacilities (65 fed. reg. 14,289 (mar. 16, 2000)); individual and small group physician practices (65 fed. reg. 59,434 (oct. 5, 2000)); ambulance suppliers (68 fed. reg. 14,245 (mar. 24, 2003)); pharmaceutical manu­ facturers (68 fed. reg. 23,731 (may 5, 2003)). 133. office of inspector gen., dep't of health & human servs., work plan fiscal year2004,athttp://oig.hhs.gov/publications/docs/workplan/2004/work%20plan%202004.pdf (last visited mar. 9, 2004). 134. /d. 135. u.s. sentencing comm'n, 2003 sentencing guideune manual ch. 8, available at http://www.ussc.gov/2003guid/chap8.htm (last visited mar. 9, 2004) [hereinafter sen­ tencing guideunes]. 2004] health care organizations and the impucations of soxa 199 program to prevent and detect violations of law."136 the importance of the sentencing guidelines "recommendation" for an effective compliance pro­ gram, and its relevance for a governing board, received a significant boost following the caremark137 decision in 1996. central to any corporate compliance program is the role of the organiza­ tion's governing board. this important role was emphasized and discussed in a recent joint publication of the oig and the american health lawyers association. 138 in that publication, not only are the traditional fiduciary duties of loyalty and due care described, but with respect to the oversight responsi­ bility of the latter, corporate board compliance activities are discussed in a way that requires the board to assure that the organization (1) has a function­ ing information reporting system and (2) such a system provides the board with timely information that will enable the organization to achieve compli­ ance with applicable laws.139 in the face of an ever increasing compilation of healthcare statutes and regulations, and the expanding array of technological advances and broad service offerings, an effective compliance program, with its attendant policies, protocols, and procedures, is a crucial managerial tool today for healthcare providers and their governing boards to achieve meaningful oversight of their organization's day to day activities. vii. sarbanes-oxley and related principles in response to the enron implosion, president george w. bush signed soxa on july 30, 2002.140 soxa is designed to uphold the integrity of financial reports submitted to the sec by publicly-traded companies and protect the shareholders of such companies from severe fmancial loss. 141 136. /d. § 8c2.5(t). for healthcare providers, the department of health and human services through its oig has, in fact, published compliance program guidance documents. the content of such compliance program guidance documents will play a significant role in deter­ mining whether the organization has developed an effective compliance program to ensure com­ pliance with the various laws under which it is obligated to conduct its activities. see u.s. dep't of health & human servs. office of inspector gen., fraud prevention and detection compliance guidance at http: //www.oig.hhs.gov/fraudlcomplianceguidance.html#l (last visited may 3, 2004). 137. in re caremark int'l inc. derivative litigation, 698 a.2d 959 (del. ch. 1996). 138. officeofinspectorgen.,u.s.dep'tofhealth&humanservs.&am.health la wyers ass'n, corporate responsibility and corporate compliance: a resource for health care boards of directors, at http://oig.hhs.gov/fraudldocs/complianceguidancei040203corp resprsceguide.pdf (last visited mar. 9, 2004) [hereinafter corporate responsibility]. 139. id. 140. sarbanes-oxley actof2002, pub. l. no. 107-204, 116 stat 745 (2002)(codifiedin scattered sections of 15 u.s.c.) [hereinafter soxa]. 141. cynthia a glassman, sec comm'r, sarbanes-oxley and the idea of "good" gover­ nance, speech before the american society of corporate secretaries (sept. 27, 2002), at http://www.sec.gov/news/speech/spch586.htm. the commissioner stated that the impetus behind the quick government response to the enron and other corporate scandals is the "effect 200 indiana health law review [vol. 1:175 soxa and the sec's quick regulatory response to enron and other corporate scandals reflect strict governance standards that require top corporate officials in publicly traded companies to be held accountable for a company's financial accountings and disclosures and to act as the "conscience" of the company, all in an effort to prevent fraudulent acts and potentially harmful conflicts of interest.142 failure to adhere to these new corporate governance standards will subject such officials to substantial penalties. 143 the corporate governance policies of soxa include: heightened accountability for financial reports that are submitted to the sec along with augmented disclosures concerning the internal controls of a company; enhanced professional responsibility of corporate attorneys to report evidence of a material violation of the securities laws; internal independent corporate audit committees; and external auditor independence.144 two other areas that soxa highlights include prohibiting company officials from fraudulently influencing the company's external auditor and enhanced conflict of interest provisions making it unlawful for a company to extend a personal loan to any director or executive officer, except for certain commercial loans that would be made to the general public.145 a. accountability for financial reports one of the key aspects of soxa' s new corporate governance standards is the heightened amount of responsibility executive officers have in overseeing the financial reports submitted to the sec146 and the corresponding these scandals have had on innocent investors." /d. approximately "88 million shareholders, representing 51 percent of u.s. households, invest in the markets today . . . ... /d. the com­ missioner stated that the increase in the number of shareholders is largely due to the popularity of employee 40l(k) plans. id. these employee stock plads have provided many benefits for employee investors, but these plans have also led many employees to invest most of their money in one company instead of diversifying their stock portfolio; thus, placing these investors at risk of a greater financial loss if there is financial fraud perpetrated by the company. id. 142. /d. 143. soxa § 1106, 15 u.s.c. § 78ff(a) (2004). the enactment of soxa increased the criminal penalties for those who violate any of the sec laws. rules, or regulations. a person who commits a willful violation can receive up to a $5,000,000 fine or up to twenty years in prison or both; if it is not possible to convict a "natural" person, then a fine of up to $25,000,000 may be imposed upon a company. /d. 144. soxa §§ 201-501 (codified in scattered sections of 15 u.s.c.). 145. /d. 146. soxa § 302(a)(6), 15 u.s.c. § 7241. the chief executive officer ("ceo") or chief financial officer (''cfo") of a company is required to certify in each financial report filed with the sec that such officer has: (1) reviewed the report; (2) determined that the report contains all relevant information and such information is not false or misleading; (3) determined that the report is an accurate description of the ~al health of the company; (4) evaluated the company's internal controls regarding financial matters and reported to the external auditors any substantial deficiencies in the internal controls that could possibly affect the outcome of the financial report; (5) reported to the external auditors any fraud regarding those employees who 2004] healtiicare 0rgan1zations and tile implications of soxa 201 penalties for failure to comply. three basic requirements included within this enhanced responsibility and oversight for financial reporting are: (1) maintain all of the internal controls within the company that oversee the company's financial reporting practices; (2) provide a written annual evaluation of the effectiveness of such internal controls; and (3) review and attest to the annual evaluation by the external auditor and submission of that attestation along with the company's financial report to the sec.147 concerning the first requirement, an independent public company accounting oversight board ("pcaob")148 was established; it will require internal control policies and procedures relating to a company's "maintenance of accounting records, the authorization of receipts and disbursements," the protection of assets, and its "process for preparing financial statements in accordance with generally accepted accounting principles."149 under the second requirement, the executive officers of a company are required to pre­ pare an annual written evaluation of the company's internal control systems that recognizes the executive's responsibility for the control systems and identifies any "material weaknesses" in any of the control systems.150 take part in the internal controls of the company; and (6) "indicated in the report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls." /d. 147. soxa §§ 302,404, ls u.s.c. §§ 7241,7262. 148. soxa §§ 101-09, 15 u.s.c. §§ 7211-19. the pcaob is not an agency of the government but instead is a nonprofit corporation, formed for the pmpose of overseeing financial audits of publicly-traded compllllies. ld. the pcaob also has the power to investigate, inspect, and sanction public accounting firms. id. furthermore, to protnote high professional standards, the pcaob may promulgate rules or orders concerning any aspect of the auditing process. id. 149. pub. co. accounting0versigiitbd., briefing paper, proposed auditing standard -an. audit of internal control over fmancial reporting performed in conjunction with an audit of financial statements, oct. 7, 2003 at 2, available at http://www .pcaobus.orglrules/ 2003-10-07 _proposed_auditing__standard.pdf [hereinafter proposed auditing standard]. 150. management's reports on intemal control over fmancial reporting and certification of disclosure in exchange act periodic reports, 68 fed. reg. 36,636, 36,642 (june 18, 2003). the sec stated that the committee of sponsoring organizations of the treadway commission control framework met its criteria regarding the evaluation of a company's internal control mechanisms. ld. see also comm. of sponsoring orgs. of the treadway comm'n ("coso"), internal control-integrat.ed framework-&ecutive ·summary, available at http://www.coso .org/publications/executive_summary_integrafed_framework.htmoastvisited dec. 30, 2003). coso is a private organization with the goal of improving the quality of financial reporting through business ethics, appropriate internal controls, and corporate governance. id. coso sets forth five components of internal control: (1) control environment that sets the corporate mood and operating style; (2) assessment of potential financial risks; (3) control activities consisting of policies and procedures regarding all financial aspects of a company; (4) a process for tnonitoring internal control systems with appropriate reporting procedures for deficiencies; and (5) the identification of pertinent financial information or factors that could possibly affect the company's financial status and proper communication among all levels of a company. pcaob, an audit oflnternal control over financial reporting performed in conjunction with an audit offmancial statements, proposed auditing standard a-50-s 1 (oct. 7, 2003), available at http://www.pcaobus.org/rules/release2003-017 .pdf. the 202 indiana healtii law review [vol. 1:175 concerning the third requirement, the external auditor's review will evaluate the executive's evaluation and reveal whether there are any material weak­ nesses that should have been included in the internal control report. 151 if all requisite steps are followed regarding the enhanced financial reporting standards, the result should be a strong set of checks and balances that promote the new and improved corporate conscience concerning corporate accountability and responsibility. b. ethical obligations for corporate counsel soxa has also had a dramatic effect on the relationships among corporations and their legal counsel. section 307 of soxa requires attorneys "appearing and practicing before the commission ... to report evidence of a material violation of securities law or breach of fiduciary duty ... by the company ... to the chieflegal counsel or the chief executive officer."152 if the chief legal counsel or chief executive officer does not respond appropriately to the attorney's report, the attorney must then report the material violation "up the ladder" to the corporation's audit committee.153 this may appear to be irrelevant for nonprofit organizations since soxa principally relates to publicly-traded, for-profit corporations. nonetheless, the "ripple effect" of these relatively narrow provisions reveals how a legislative initiative in one arena can spread to have an impact beyond the initial confines of the statute. the sec significantly expanded § 307 by publishing its final rules regarding professional conduct for attorneys on february 6, 2003.154 first, the final rules broadly defined what attorneys would be considered as "appearing pcaob also sets forth certain requirements pertaining to the external auditor's attestation report. !d. 151. proposed auditing standard, supra note 149. 152. soxa § 307, 15 u.s.c. § 7245; see also 17 c.f.r. § 205.2 (2004). "material violation" is defined as an activity that would violate any federal or state laws, any securities laws, or "a material breach of fiduciary duty arising under federal or state law." !d. 153. soxa § 307, 15 u.s.c. § 7245 (suggesting that an appropriate response would be issuing sanctions or providing remedial measures concerning the material violation); 17 c.f .r. § 205.3. 154. implementation of standards of professional conduct for attorneys, 68 fed. reg. 6296 (feb. 6, 2003) (codified at 17 c.f.r. § 205). the rationale behind the promulgation of the standards of professional conduct for attorneys was to protect shareholders and promote shareholder confidence in public companies by requiring attorneys employed or retained by such companies to respond swiftly and affinnatively to any possible material violation of the sec's rules. !d. section 205.1 sets forth that the professional standards supplied by the sec shall supplant any conflicting state standards. /d. the sec explained in the final rule that their standards are not meant to preempt more stringent state standards. id. however, the sec's standards will apply over less stringent or conflicting state standards. !d. in addition to the already codified rules that have extended the original professional standards of soxa, the sec is still considering the requirement of a ''noisy withdrawal"-wbereby the withdrawing attorney must notify the sec of his or her withdrawal-by an attorney who did not receive an appro­ priate response from a company after reporting evidence of a material violation. /d. 2004] hbalthcare organizations and the impllcations of soxa 203 and practicing., before the sec. 155 second, the final rules allow corporate counsel to skip a step in the chain of command by reporting a suspected material violation directly to the audit committee, thus bypassing the chief legal officer or chief executive officer. 156 furthermore, under certain circum­ stances, a reporting attorney who reasonably believes that he or she did not receive an appropriate response in a reasonable amount of time from the audit committee may report the suspected material violation to the sec without the consent of the corporation. 157 third, the sec imposes the same disclosure requirements on any supervisory attorney as on the subordinate reporting attorney.158 fmally, the final rules set forth that an attorney not in compliance with the standards of professional conduct will be subject to civil penalties and sec disciplinary actions. 159 in response to the sec's new standards of professional responsibility for attorneys, the american bar association's ("aba .. ) house of delegates revised its model rules of professional conduct, specifically rules 1.6 and 1.13, to allow attorneys to comply with the reporting responsibilities ofsoxa 155. 17 c.p.r. §§ 205.2, 205.3. the sec defines "appearing and practicing" before the sec as: (1) any form of communication with the sec; (2) representing a corporation in a sec administrative proceeding or any other type of investigation or activity with the sec; (3) advising clients on any aspect of securities laws or the sec's rules and regulations in preparation of tiling any documentation; and (4) providing advice to a corporation concerning whether or not information is required to be filed with the sec. id. see also implementation of standards of professional conduct for attorneys, 68 fed. reg. at 6296. the sec set forth that an attorney "appearing and practicing" before the commission need not be employed as an in-house attorney for a company-there only needs to be an attorney-client relationship and such a relationship can be formed without evidence of a formal retainer. id. a clarification in the final rules explains that attorneys are not considered as "practicing or appearing'' before the commission if they had no notice or never intended a document to be filed with the sec. id. 156. 17 c.p.r.§ 205.3(b)(4) (setting forth that the reporting attorney must reasonably believe ''that it would be futile to report evidence of a material violation to the issuer's chief legal officer and chief executive officer''). 157. id. § 205.3( d)(2). the sec sets forth three sets of circumstances in which a reporting attorney may report the material violation to the sec without the corporation's approval: (1) stopping an issuer from committing a material violation that would adversely affect the financial interest of the corporation or its investors; (2) preventing a corporation from committing perjury, suborning perjury or committing an act that is likely to "perpetrate a fraud upon the com­ mission;" or (3) remedying a material violation that caused great financial injury to the corpora­ tion or its investors "in the furtherance of which the attorney's services were used." id. 158. id. § 205.4 (2004). see also id. § 205.2(b) (defining "appropriate response" as a response to the reporting attorney in which such attorney reasonably believes that: no material violation has occurred or is likely to occur in the future; the company has taken steps to remedy any ongoing material violations or prevent any violations from occurring in the future; or the company, with the consent of the audit committee, bas hired another attorney to investigate and evaluate whether a material violation has occurred). 159. id. §§ 205.6-205.7. section 205.6 also sets forth that attorneys acting in good faith in complying with the sec rules will not be "subject to discipline or otherwise liable under in­ consistent standards imposed by any state." 17 c.p.r.§§ 205.6-205.7. moreover, section 205.7 gives the sec exclusive rights to enforce its required standards of professional conduct. /d. 204 indiana healtii law review [vol. 1:175 and to disclose confidential information to prevent fmancial injuries. the aba extended model rule 1.6 beyond disclosure of acts that will result in bodily hann or death; now an attorney may also disclose confidential informa­ tion without consent to preclude any "substantial injury to financial interests or property of another."160 before the revision of model rule 1.13, attorneys -were only allowed to report unlawful acts of a company to a higher authority within the company; now under certain circumstances, an attorney may also report such unlawful acts to the sec.161 thus, the aba has removed many of the ethical obstacles that formerly served as deterrents to reporting "up the ladder." although the model rules were amended to reflect the goals of soxa, the states must now (because the model rules are not legally binding) decide whether to revise their own rules of ethics to comply with the sec's standards or to maintain the status quo. 160. model rules of prof'l conduct r. 1.6 (2003), available at http://www.abanet .orglleadership/2003/journal/119a.pdf (last visited mar. 9, 2004) [hereinafter model rules]. rule 1.6 states in relevant part: i d. a lawyer may reveal information relating to the representation of a client to the extent the lawyer reasonably believes necessary: to prevent reasonably certain death or substantial bodily harm; to prevent the client from committing a crime or fraud that is reasonably certain to result in substantial injury to the fmancial interests or property of another and in furtherance of which the client has used or is using the lawyer's services; to prevent, mitigate or rectify substantial injury to the financial interests or property of another that is reasonably certain to result or has resulted from the client's commission of a crime or fraud in furtherance of which the client has used the lawyer's services; to secure legal advice about the lawyer's compliance with these rules .... 161. ld. at r.l.13, available at http://www.abanet.org/cpr/mrpc/new_rulel_l3.pdf (last visited mar. 9, 2004). rule 1.13 states in relevant part: !d. if a lawyer for an organization knows that an officer, employee or other person associated with the organization is engaged in action, intends to act or refuses to act in a matter related to the representation that is a violation of a legal obligation to the organization, or a violation of law that reasonably might be imputed to the organization, and that is likely to result in substantial injury to the organization, then the lawyer shall proceed as is reasonably necessary in the best interest of the organization. unless the lawyer reasonably believes that it is not necessary in the best interest of the organization to do so, the lawyer shall refer the matter to higher authority in the organization, including, if warranted by the circumstances to the highest authority that can act on behalf of the organization as determined by applicable law. except ... if despite the lawyer's efforts ... the highest authority that can act on behalf of the organization insists upon or fails to address in a timely and appropriate manner an action, or a refusal to act, that is clearly a violation of law, and the lawyer reasonably believes that the violation is reasonably certain to result in substantial injury to the organization, then the lawyer may reveal information relating to the representation whether or not rule 1.6 permits such disclosure, but only if and to the extent the lawyer reasonably believes necessar· •'l prevent substantial injury to the organization. 2004] healthcare organizations and the impucations of soxa 205 c. role of independent auditors internally and externally soxa also requires an "independent" accounting ftrm. to perform the financial audits for a corporation.162 one safeguard through which soxa en­ sures auditor independence is by requiring auditors to submit reports directly to a corporation's audit committee,163 composed of board members who are not employed by or under contract (e.g., as an independent consultant) with the corporation. another significant safeguard is that an accounting firm pro­ viding auditing services is prohibited from contemporaneously supplying the corporation with non-audit services including a wide variety of financial and management consulting services. 164 however, soxa does allow certain non­ auditing services to be performed by the same accounting firm subject to pre­ approval by the corporation's audit committee.165 auditor independence is also safeguarded by the requirement of audit partner rotation.166 to maintain a "fresh look'' with regard to the external auditing team, the sec requires that audit partners, the persons who are primarily responsible for coordinating and overseeing the audit, be rotated to another assignment after five years of consecutive service with the same corporation. 167 soxa provides a similar safeguard regarding independent 162. soxa § 204, 15 u.s.c. § 78j-l(k) (2004). auditors must provide the audit com­ mittee with infonnation regarding all ac::countingprocesses to be employed during the audit, "all alternative treatments of financial information within generally accepted ac::counting principles that have been discussed with management officials" of the corporation, the consequences of utilizing such alternative treatments, which treatment is favored by the auditors, and finally, any substantial written communication between the auditors and the corporation's management regarding the audit. /d. 163. /d. 164. soxa § 201, 15 u.s.c. §§ 78j-1(g)-(h). prohibited non-auditing services include: services related to accounting records; ''financial information systems design and implementa­ tion; actuarial services; internal audit outsourcing services;" managerial duties; financial invest­ ment services; "legal services and expert services unrelated to the audit; and any other service that the [pcao] board determines, by regulation, is impermissible." /d. 165. soxa §§ 201-02, 15 u.s.c. § 78j-1 (g)-(i). any non-auditing service not mentioned in§ 201 may be allowed but must be pre-approved by the corporation's audit committee. /d. moreover, the specific services listed in§ 201 may be performed by a corporation's auditing team if the pcaob determines that an exemption of such services is necessary for the protection of a corporation's shareholders or in the public's best interest. /d. the pre-approval requirement is waived if: 1) the total amount paid to the ac::counting firm for non-audit services does not exceed five percent of the compensation paid by the corporation to the accounting firm during the fiscal year; 2) the corporation did not consider the services to be non-auditing services at the time the accounting firm was hired to perform auditing services; and 3) such services are promptly reported to the corporation's audit committee and the committee approves such services prior to the completion of the audit. /d. 166. soxa § 203, 15 u.s.c. § 78j-l(j). 167. /d. see also strengthening the commission's requirements regarding auditor independence, 68 fed. reg. 6006,6017 (feb. 5, 2003); 17 c.f.r. § 210.2-0l(f)(7)(ii) (2004). the sec defines an audit partner as a person "who is a member of the audit engagement team who has responsibility for decision-making on significant auditing, ac::counting, and reporting matters ..•. " 17 c.f.r. § 210.2-0l(f)(7)(ii). an audit partner includes lead or coordinating 206 indiana heal1h law revlew [vol. 1:175 auditors: it is unlawful for an accounting firm to perform a financial audit of a corporation that has hired one of its former employees who ''participated in any capacity" in a previous audit of that corporation during the one year time period preceding the initiation of any subsequent audit.168 the sec defines this one-year time lapse as a "cooling off' period in which any conflicts of interest could dissipate.169 vill. impucations for the nonprofit healuicare organization just as the development of "corporate compliance" incentivized health­ care organizations to respond to specific concerns, such as billing matters, soxa provides a similar incentive for entities to internally develop a governance compliance program. while soxa principally relates to for­ profit, publicly-traded companies rather than nonprofits, 170 it can assist them in identifying issues of concern in order to develop an appropriate governance compliance program. some of the specific suggestions that soxa lends to non profits are set forth below. a. expansion and clarity of conflicts of interest policies conflicts of interest, both disclosed and undisclosed, were sources of some of the most serious charges raised in the healthsouth proceedings. the irs has underscored the importance of this issue for tax-exempt organizations since 1997 through its imprimatur on a sample conflicts of interest policy for adoption by governing boards. soxa focuses on company loans to directors or executives of the company. however, the concerns of the multiple "constituency groups" that oversee, regulate, or otherwise hold a nonprofit organization accountable demonstrate a broader range of potential conflict partners, partners who perform a subsequent level of review ensuring that the audit complies with generally accepted accounting principles, and other partners "who provide more than ten hours of audit, review, or attest services in connection with the annual ... financial statements .... " id. § 210.2-01(t)(7xii)(c). 168. soxa § 206, 15 u.s.c. § 78j-1(/). see also u.s. strengthening the commission's requirements regarding auditor independence, 68 fed. reg. at 6008 n.32. persons subject to the conflicts of interest provision include the lead partner, concurring partner, and any other person involved in the audit who has provided "more than ten hours of service during the audit period." id. the lead and concurring partners of the auditing team ate not subject to the ten­ hour requirement; they are always subject to the conflicts of interest provision regardless of the amount of time spent on the audil id. the prohibited time period begins the day after the prior year's financial report to the sec was filed and ends when the current year's report is filed with the sec; hence, the "one year'' time period could actually be longer. ld. at 6009. 169. ld. at6007. 170. soxa § 1107, 18 u.s.c. § 1513(e); see also discussion infra part viit.f. 2004] healthcare organizations and the implications of soxa 207 transactions. 171 the trend in nonprofit healthcare organizations to engage in business transactions and joint ventures with for-profit entities prompted the irs to develop its conflicts of interest policy .172 the challenge for governing boards now is to extend their conceptual understanding of a "conflict" beyond the realm of such financial transactions. for instance, a board member or senior manager may present a conflict for the organization in meeting its community benefit obligations, or in satisfying a credentialing standard for a healthcare professional. a conflicts of interest policy must define the "interests" of the organization in sufficiently broad terms so that full disclo­ sures from decision makers can be secured. this will also help educate the governing board on its expanding responsibility for proper "corporate gover­ nance." b. policies for board audit committees soxa contains several provisions directed at "independence" in the audit process. this was certainly an issue in the enron and worldcom set­ tings.173 an internal target for this concern in soxa is a company's audit committee. soxa requires that the audit committee members be independent of management and a compensation relationship (e.g., as a consultant) with the company. soxa also raises the issue of competence by implying that a financial expert serves on the audit committee. soxa squarely addresses the importance of an independent audit committee and the role it performs. while it may concentrate on the com­ pleteness and accuracy of financial statements, an audit committee for a non­ profit healthcare organization is faced with many other areas of inquiry and oversight. examples of unique concerns for the nonprofit's governing board are loss of tax-exempt status and imposition of intermediate sanctions. severe penalties for noncompliance in the billing, accreditation, or medicare and medicaid certification areas of operation reflect unique con­ cerns for the committee arising out of the healthcare field. training in finan­ cialliteracy as well as corporate compliance will lead to increased recruitment burdens for the nonprofit organizations seeking broad community representa­ tion on its governing board. 174 these considerations will soon become the "best practices" and then the "standard of care" for finance and audit com­ mittees. accordingly, nonprofit healthcare organizations will need to begin developing policies so that their committees meet these expectations. 171. see boardsource & independent sector, new report offers nonprofits guidance on the sarbanes-oxley act (oct. 10, 2003), at http://www.independentsector.org/media/ sarbanesoxleypr.html. 172. see brauer & kaiser, supra note 80. 173. see michael w. peregrine et al., the new "corporate responsibility" law: how it affects health care, 11 health l. rep. (bna) 1231 (aug. 22, 2002). 174. see boardsource & independent sector, supra note 171. 208 indiana health law review [vol. 1:175 c. evaluation and use of independent auditors the independence of the outside auditor was an inevitable target of concern for soxa. several of the corporate scandals leading up to the passage of soxa involved serious questions of independence. this has been a growing concern in recent years as accounting fmns developed a variety of consulting services to be "cross-marketed" to their audit clients. soxa responded to these developments in two primary ways that have implications for nonprofit healthcare organizations. the first is the rotation of the audit firm's lead and reviewing partner (or the rotation of the audit firm itself) every five years. the second is a prohibition of the audit firm from providing a variety of non-audit services. due to the limited number of accounting fums with expertise in the essential financial features of reimbursement for healthcare services as well as accounting practices for tax-exempt entities, the utilization of independent auditors may present special problems for nonprofit healthcare organizations. using other organizations for consulting will reinforce the organization's commitment to avoiding conflicts of interest this will also provide "checks and balances" for the recommendations from consultants, who may primarily focus on revenue generation without consideration of the other "constituen­ cies" and purposes to be served by the nonprofit healthcare provider. d. policies and protocols for financial reports a key feature of soxa is the requirement that a company's ceo and cfo certify the accuracy and fair presentation of the financial condition of the company when they sign the company's financial statements. financial and criminal penalties add ''teeth" to this requirement this requirement is intend­ ed to assure the accuracy of financial reports in order to enhance the integrity of the financial markets for lenders and investors. once again, nonprofit healthcare organizations must be concerned with a broader range of "consti­ tuency groups" aside from the investment community. healthcare providers already face the possibility of severe financial and criminal repercussions threatened by regulatory agencies and other govern­ mental authorities. exposure to civil and criminal penalties for the submission of false claims to third party payors serves the purpose of encouraging a healthcare provider's governing board to ensure the accuracy and complete­ ness of the financial systems and controls. accuracy in form 990s, which re­ quires the signature of an officer of the organization, is currently sporadic, but may become a source of additional individual or organizational liability. 175 as 175. see id. 2004] healthcare organizations and the implications of soxa 209 state attorneys general seek greater authority to oversee broad "community benefit" questions for nonprofit organizations, financial reports and tax returns will need to accurately disclose additional aspects of compliance. ultimately, the governing board must develop policies and protocols for financial report­ ing and disclosure that address these growing concerns and potential liabilities. e. procedures for legal counsel's advice to board and management soxa and the aba are raising similar issues that may dramatically affect the role of legal counsel for, and their relationship to, the publicly­ traded, for-profit corporation. the focus of soxa is to encourage an attorney for an organization to report a "material violation" of a state or federal law to the ceo or chief legal officer in order to receive an "appropriate response." the aba' s modification of the rules of professional responsibility was intended to encourage attorneys to take action-that he or she reasonably believes is necessary to address illegal activity by or on behalf of the organization-when that activity is likely to result in substantial injury to the organization. given the multitude of regulations, statutes, and accreditation standards applicable to healthcare organizations, these developments may present difficult and complicated implications. while these implications may appear drastic to others, "many health care lawyers are already sensitive to the manner in which compliance concerns are addressed by the client."176 the importance of this development was foreshadowed by the indictment of healthcare attorneys involved in drafting documents for a hospital system seeking a legitimate contractual relationship with referring physicians. 177 government prosecutors seeking waivers of attorney-client privileges and regulatory agencies encouraging corporate compliance programs that result in self-reporting of wrongful acts are further examples of the disturbance of the "traditional" insulated attorney-client relationship for healthcare organizations. the nonprofit governing board will be required to develop reporting mechanisms that recognize and respond to the constriction of the privileged and confidential relationship, while facing increased exposure from many directions. f. whistle-blower procedures and protections many states, whether by statute or court decisions, have extended protections to whistle-blowers. soxa provides protection in the form of 176. peregrine, supra note 173, at 35. 177. united states v. anderson, 85 f. supp. 2d 1047 (d. kan. 1999), rev'd in part by united states v. mcclatchey, 217 f.3d 823 (1oth cir. 2000), and affd in part by united states v. lahue, 254 f.3d 900 (loth cir. 2001). 210 indiana health law review [vol. 1:175 criminal penalties against an organization that seeks to retaliate against a whistle-blowing employee who provides information about illegal activity to federal authorities. these penalties provide enforcement ''teeth" to arrange­ ments many healthcare organizations incorporate into their corporate compliance plans in which whistle-blowers can report violations anonymously and with assurances of non-retaliation. soxa serves as an anticipated extension of the federal government's expectations under various model corporate compliance plans that have been published in recent years. nonprofit healthcare organizations are burdened with standards and obligations from many sources, so the potential variety of whistle-blowers could become a large symphony. it is reasonable to anticipate that the standards currently imposed and enforced by regulatory agencies will serve as areas of protection for whistle-blowers in light of the increased expectation of corporate compliance and self-reporting programs. this is important since § 1107 of soxa expressly prohibits any person or organiza­ tion, whether for-profit or nonprofit, from retaliating against an employee for providing truthful information to a law enforcement officer relating to the commission or possible commission of any federal offense.178 it is vital for the governing board to establish a culture of compliance, since retaliation is generally imposed by supervisors and senior management. in addition, it is also important for the governing board to establish a compliance committee on the board, with mechanisms for reporting and oversight. g. document management, retention, and production policies one of the critical features of the enron scandal relates to the destruc­ tion of internal financial and legal documents. obstruction of an investigation has been an important criminal penalty in the arsenal of federal authorities. soxa enhances this area of enforcement by making it a crime to alter, cover up, falsify, or destroy any document to prevent its use in any federal investigation or official proceeding. healthcare organizations are currently subjected to concurrent or retrospective audits by third-party payors, government agencies, and accreditation organizations. therefore, the avail­ ability of complete and accurate records is a significant priority. there is increased scrutiny of tax-exempt and healthcare organizations by agencies, authorities, and other interests desiring greater transparency, accessibility, and compliance. as a result, nonprofit governing boards will need to assess the sources of such oversight. perhaps more challenging will be to anticipate what documents, reports, or other information these entities might want to review or inspect years in the future relative to the organiza­ tion's current activities. a document management and retention policy to respond to such retrospective evaluations is an important issue for the 178. soxa § 1107, 18 u.s.c. § 1513(e)(2004). 2004] healthcare organizations and the implications of soxa 211 governing board. the recent corporate scandals and the criminal enforcement features of soxa in this area highlight the significance of the policy. ix. conclusion it is inevitable that an organization's activities today will be retros­ pectively judged in the future through a lens that applies future standards. members of governing boards for nonprofit healthcare organizations must be aware of that probability as they study the rapid changes taking place with respect to the standards and expectations for corporate governance. the public to be served has become more multifaceted, and the sources for accountability have increased. the consequences of ignoring one's duties on a board are increasingly complicated and threatening for the board member and the organization. nonprofits should not view these various developments narrowly or in isolation. rather, they should strive to understand the broader and deeper context of "corporate governance," so that the single legislative initiative represented by soxa can be better appreciated. on its face, soxa may be dismissed or given little attention since it only applies to for-profit, publicly­ traded corporations. however, in the broader context, as described in this article, soxa can and should be more fully appreciated as a catalyst of change, enhancing the responsibilities of the nonprofit healthcare organiza­ tion's governing board to meet the needs of its community. gone are the days when a community leader can simply "show up" for periodic meetings and fund-raising events and fulfill his or her civic duty on the community hospital board. state and federal laws, regulations, and standards are undergoing significant changes, and high-profile scandals raise the political profile of governance issues, resulting in legislative enactments and oversight investigations. the nonprofit governing board of today needs to understand these developments and anticipate the scrutiny that both it and its organization will face tomorrow. improving indiana's mandatory immunization programs matt lasher • i. introduction ............................................................................... 118 ii. the purposes for and considerations of mandatory ........... .. vaccination programs .............................................................. 120 a. the health and socio-economic impacts of communicable and i"lfectious diseases ................................................................... 120 b. the rise of vaccination: the reduction and elimination of endemic diseases .................................................................... 121 c. remaining vpd risks compel continuation of universal immunizations .......................................................................... 123 d. increasing numbers of parents resist childhood immunizations .......................................................................... 125 i. the inherent risks of vaccinations ................................... 125 2. addressing the risks: using risk balancing to design vaccination programs ........................................................ 126 3. misunderstanding the relative risks: are parents afraid of the right threats? ............................................................... 127 e. the harms of mandatory vaccination exemptions: the problem ofthe commons . ...................................................................... 129 i. vaccination coverage and herd immunity as a public common ............................................................................. 129 2. avoiding the tragedy of the public health common through state action ........................................................................ 130 ill. the current structure of mandatory immunization ........... . programs among the states .................................................... 131 a. the primary method of promoting immunization against vpds ........................................................................................ 132 b. secondary efforts: targeting populations and disseminating information .............................................................................. 133 c. the available exemptions from mandatory immunization requirements ........................................................................... 134 i. medical exemptions ........................................................... 135 2. religious exemptions ......................................................... 136 3. philosophical (personal belief) exemptions ...................... 141 4. exemptions of convenience ............................................... 142 • j.d. candidate, 2010, indiana university school of lawindianapolis; b.s. in microbiology, 2000, indiana university. the author has received vaccinations against anth­ rax, diphtheria, hepatitis a and b, haemophilus influenza type b, influenza, measles, menin­ gococcal, mumps, pertussis, polio, rubella, smallpox, tetanus, typhoid, and yellow fever. 118 indiana health law review [vol. 7:117 iv. analysis of indiana's mandatory immunization programs ...................................................................................... l43 a. the current structure of indiana's mandatory immunization program ................................................................................... 144 1. primary immunization efforts: efficient targeting of populations ........................................................................ 144 2. secondary immunization efforts: educating the public about vpds ....................................................... : .......................... 146 3. enforcement of mandatory immunization requirements in indiana ............................................................................... 146 4. the mandatory immunization exemptions available to hoosiers ............................................................................ 147 a. exemptions in the case of medical contraindication .. 147 b. exemptions in the case of conflicting religious beliefs 148 b. recommended changes to indiana's mandatory immunization provisions ................................................................................ 149 1. the current state ofvaccination.coverage and exemption· prevalence ......................................................................... 149 2. amending the religious exemption statutory provisions .... 150 3. advocating the taboo: incorporating philosophical exemptions ......................................................................... l52 4. revisions of mandatory immunization reporting requirements .................................................................. ; ... 154 5. attempting to internalize the negative externalities of immunization exemption., .................................................. 155 v. conclusion .................................................................................. 156 i. introduction after vaccinations against infectious diseases became available near the end of the nineteenth century, 1 the united states experienced a remark­ able reduction in morbidity and mortality suffered as a result of vaccine­ preventable diseases through the widespread use of immunization pro­ grams. 2 these state programs, which involve the compulsory vaccination of school-aged children,3 not only eliminated endemic infections domesti1. see robert langreth, booster shot, a new golden age of vaccines is at hand, promising inoculations against malaria, meningitis, and much more, forbes, nov. 12, 2007, at 79 (discussing dr. jenner's discovery of smallpox prevention techniques). 2. see centers for disease control and prevention, achievements in public health, i900-1999: control of infectious disease, 48 morbidity & mortality wkly rep. 621, 624 (1999) [hereinafter control of infectious disease] (discussing the success of vaccination programs). 3. see kevin m. malone & ala.l>i r. hinman, vaccination mandates: the public health imperative and individual rights, in law in public health practice 338, 355 (ri­ chard a. goodman ed., 2d ed. 2007). 2010] mandatory immunization programs i 19 cally but also enabled the eradication of some diseases in the united states and throughout the world.4 due in part to the success of these vaccination efforts, many american parents are unfamiliar with the risks posed by these once-prevalent diseas­ es.5 consequently, many parents now resist mandatory vaccinations for their children because they fear the potential adverse effects of vaccinations more than the diseases the vaccines prevent. 6 as more parents seek to avoid vaccinations through statutory exemptions from mandatory immuni­ zation programs, 7 the public health achievements of these programs in­ cluding herd immunity and decreased socio-economic costs are at risk of collapse. 8 international travel now reintroduces communicable diseases once eliminated from or greatly curtailed in the united states.9 indiana it­ self narrowly averted a costly outbreak of measles in the alarmingly recent past.10 section ll of this note will demonstrate that the continuing risks posed by vaccine-preventable diseases compel states to continue enforcing mandatory immunization programs and to minimize exemptions that can lead to a tragedy of the public health common. it will then discuss the op­ position to these programs and the increasing number of parents seeking exemptions, focusing on the impact of those decisions by using the "trage­ dy of the commons"11 as a model for analysis. section iii will introduce the common features of mandatory vaccination programs, including exemp­ tion provisions and their constitutional implications. section iv will dis­ cuss the current structure, strengths, and weaknesses of indiana's mandatory vaccination program. finally, section iv will use the analytical framework of the tragedy of the public health common to recommend changes to indiana's statutory and regulatory provisions. 4. control of infectious disease, supra note 2, at 624. 5. steve p. calandrillo, vanishing vaccinations: why are so many americans opt­ ing out of vaccinating their children?, 37 u. mich. j.l. reform 353, 362 (2004). 6. ross d. silverman, no more kidding around: restructuring non-medical child­ hood immunization exemptions to ensure public health protection, 12 annals health l. 277,278-79 (2003). 7. see jennifer steinhauer, rising public health risk seen as more parents reject vaccines, n.y. times, mar. 21, 2008, at at. 8. see, e.g., bloomberg news, measles cases up as more shun shots, newsday, jan. 8, 2009, at a30, available at 2009 wl 351178 [hereinafter measles cases up]. 9. see centers for disease control and prevention, update: measlesunited states, january-july 2008, 57 morbidity & mortauty wkly rep. 893, 896 (2008) [hereinafter update: measles]. 10. amy a. parker et al., implications of a 2005 measles outbreak in indiana for sustained elimination of measles in the united states, 355 new eng. j. med. 447 (2006). 11. garrett hardin,· the tragedy of the commons, 162 science 1243 ( 1968). 120 indiana health law review [vol. 7:117 ii. the purposes for and considerations of mandatory vaccination programs this section discusses the reasons why states introduced and continue to employ mandatory vaccination programs. it will introduce the reader to concepts of disease prevention as well as to the benefits immunization pro­ grams confer. it will also discuss some risks inherent in immunization practices in order to introduce the considerations that legislatures and public health officials must balance when designing vaccination programs. a. the health and socio-economic impacts of communicable and infectious diseases communicable and other infectious diseases caused thousands of deaths annually in the united states and throughout the world before the advent of concerted public health efforts.12 at the turn of the twentieth cen­ tury, pneumonia, tuberculosis, and diphtheria were the first, second, and tenth leading causes of death respectively in the united states.13 in stark contrast, only septicemia and the combination of influenza and pneumonia were within the top ten by 2005.14 the benefits of preventing, reducing, or eradicating infectious diseases are not limited to reductions in mortality alone. even if an infectious dis­ ease proves non-fatal in a given case or in most cases of its infection, it may cause significant health consequences. measles, a systemic infection caused by a virulent paramyxovirus spread by aerosols, provides a startling example.15 although not usually fatal to children in industrialized nations, it creates a spreading rash, moderate to severe fevers, coughs, anorexia, and diarrhea.16 nearly a third of cases result in complications, with severe di­ arrhea, ear infections, and secondary pneumonia infections being the most common.17 even with medical treatment, some once-common vaccine­ preventable diseases can cause blindness, deafness, encephalitis, brain dam­ age, and mental retardation. 18 some infectious agents, though preventable 12. see calandrillo, supra note 5, at 362. 13. national center for health statistics, leading causes of death, 1900-1998, http://www.cdc.gov/nchsldata/dvs/leadl900_98.pdt: at 67 (last visited mar. 14, 2009). 14. hsiang-ching kung et al., deaths: final data for 2005, 56 nat'l vital stat. rep., apr. 24, 2008, at 5, available at http://www.cdc.gov/nchsldata/nvsr/nvsr56/ nvsr56 _1 o.pdf. 15. centers for disease control and prevention, epidemiology and prevention of vaccine-preventable diseases 157 (w. atkinson et al. eds., 11th ed. 2009) [hereinafter pink book]. 16. ld. at 158. 17. /d. 18. centers for disease control and prevention, what would happen if we stopped vaccinations?, http://www.cdc.gov/vaccinesfvac..gen/whatifstop.htm [hereinafter what would happen] oast visited apr. 10, 2010) (describing the impact ofhib-induced meningi2010] mandatory immunization programs 121 through vaccination, are not susceptible to commonly available treatment regimens, especially viruses and highly mutable bacteria.19 infectious diseases have implications beyond the infected individuals thus truly making them public health problems because their cumulative secondary effects create significant socio-economic consequences. infected children often miss school, and their symptoms may require doctor visits or hospitalization.20 some states, including indiana, require the exclusion of children with communicable illnesses for the duration of their infectious potential,21 resulting in missed classes. parents of young students must provide for their care and may need to take time off ofwork.22 where par­ ents cannot afford necessary treatments for students, indiana law requires that public health facilities provide the care,23 thus transferring the cost of treatments to treating facilities, public programs, taxpayers, and eventually even insurance premiums. 24 b. the rise of vaccination: the reduction and elimination of endemic diseases immunity, in the medical context, denotes an individual's ability to eliminate foreign antigens to which the body is exposed while protecting the body's own tissues.25 active immunity may either be conferred by vac­ cination or acquired from the course of exposure to and recovery from a particular antigen.26 but only vaccination enables individuals to develop some level of active immunity without having to experience the disease or risk its potential complications.27 vaccine development began its rapid evolution in the late eighteenth century when dr. edward jenner researched immunizing children against smallpox by intentionally exposing them to blisters of the closely-related cowpox disease.28 the concept of conferring immunity by exposure to non­ infectious antigens thus became alternatively known as vaccination (due to the name of the cowpox virus, vaccinia) and immunization (due to the retis, pertussis, and mumps). see also pink book, supra note 15, at 158 (describing measles­ associated encephalitis); id. at 285 (describing varicella-associated encephalitis and aseptic meningitis). 19. see control of infectious disease, supra note 2, at 624 (discussing the emergence of drug resistance in some organisms as underscoring the need for prevention). 20. what would happen, supra note 18. 21. see, e.g., ind. code ann. § 20-34-3-9(c) (west 2008) (excluding an infected student until the student is no longer has a communicable disease or poses a transmission risk). 22. what would happen, supra note 18. 23. ind. code ann.§ 20-34-3-9 (b) (west 2008). 24. see calandrillo, supra note 5, at 427-28. 25. pink book, supra note 15, at 1. 26. /d. at 3. 27. /d. 28. langreth, supra note 1, at 79. 122 indiana health law review [vol. 7:117 suiting effect of exposure).29 a ''vaccine-preventable disease" (vpd) is one for which an efficacious method of immunization has been developed and approved; the centers for disease control and prevention (cdc) currently classify twenty-seven diseases as vpds. 30 immunization practices have led to a remarkable reduction in morbidi­ ty and mortality due to vpds throughout the world.31 in the united states, vaccinations against vpds have resulted in the complete eradication of na­ turally-occurring infections of smallpox, diphtheria, and paralytic polio, as well as near-total eradication of measles, rubella, congenital rubella, and haemophilus injluenzae. 32 accordingly, the cdc proclaimed vaccinations to be one of the ten greatest public health achievements of the previous cen­ tury.33 the results of vaccination programs have been profound, consider­ ing the millions of deaths prevented, the reduced morbidity, and the cost savings to families and communities.34 universal childhood vaccination continues to be essential to these suc­ cesses because of the rampant communication of disease among young children, particularly in school and child care environments.35 by focusing on children, immunization programs arrest transmission of infectious dis­ eases by denying them footholds in high-transmission environments. in addition, making certain vaccinations requisites for school attendance "[has] been a key factor in the prevention and control of [vpds] in the united states."36 as vaccine advocate dr. paul offit noted, "in the early 1970s, public health officials found that states with vaccine mandates had rates of measles that were 50% lower than states without mandates. "37 because the prevalence of some diseases can be so dramatically re­ duced through vaccination, some targeted diseases "[can] be eradicated from all human populations through global cooperation. "38 indeed, the re­ nowned success of smallpox vaccination led to the global eradication of the variola virus by 1977.39 this eradication allowed public health authorities 29. this notes will regard the tenns "vaccinate" and "immunize" as synonyms. 30. centers for disease control and prevention. list of vaccine-preventable diseases, http://www.cdc.gov/vaccines/vpd-vaclvpd-list.htm (last visited mar. 14, 2009). 31. malone & hinman, supra note 3, at 341. 32. pink book, supra note 15, at g-7. 33. centers for disease control and prevention, ten great public health achieve­ ments-united states, 1900-1999, 48 morbidity & mortauty wkly rep. 241, 243-44 (1999) [hereinafter ten great public health achievements]. 34. see calandrillo, supra note 5, at 369. 35. see derrick henry, law on flu vaccinations may be tested, n.y. times, jan. 4, 2009, § 14 (new jersey), at 2 ("children are very effective spreaders of infection-prone se­ cretions."). 36. malone & hinman, supra note 3, at 355. 37. paul a offit, editorial, fatal exemption, wallst.j., jan. 20-21,2007, atalo. 38. control of infectious disease, supra note 2, at 624. 39. centers for disease control and prevention. laboratory-acquired vaccinia expo­ sures and infections, 51 morbidity & mortauty wkly rep. 40 l (2008). 2010] mandatory immunization programs 123 to cease routine vaccination of american children.40 the ultimate goals of immunization efforts, therefore, are the eradication of vpds and the even­ tual cessation of immunizations against them. c. remaining vpd risks compel continuation of universal immunizations although immunization efforts have curtailed vpds, the majority of vpds have not been eliminated in the united states, let alone globally.41 even in nations and communities where particular vpds have been signifi­ cantly curtailed or eliminated, periodic resurgence of those vpds occurs.42 if states suspend mandatory vaccinations prematurely, the reintroduction of vpds will likely allow their resurgence to pre-vaccination levels, and prior efforts will have diminished value.43 measles exemplifies the continuing need for universal vaccination. public health authorities successfully eliminated endemic measles transmis­ sion within the united states by the year 2000.44 yet the disease continues to afflict developing nations, 45 and it reappears even in nations with broad vaccination programs. in the united states, more measles cases were re­ ported in 2008 than in any year since its domestic eradication as a result of international travel, leading the cdc to note that "[ f]or the foreseeable fu­ ture, measles importations into the united states will continue to oc-' cur ... .'.46 public health officials link the outbreaks to lowered immunization rates. outbreaks in great britain and its territories appear to have resulted from a decline in vaccination coverage.47 the cdc noted similar indicators of poor vaccination coverage for outbreaks in the united states.48 measles even resurfaced in indiana during a 2005 outbreak that occurred among predominantly unvaccinated individuals.49 while vaccination programs entail some expenses and inherent risks, they confer multiple essential benefits that strongly outweigh these costs. the primary benefits inure to the vaccinated individual who is largely 40. id. 41. see ten great public health achievements, supra note 33, at 247 ("despite the dramatic declines in [vpds], such diseases persist, particularly in developing countries."). 42. see pink book, supra note 15, at 31 ("the viruses and bacteria that cause [vpds] . . . still exist and can be passed on to unprotected persons or imported from other coun­ tries .... "). 43. /d. 44. update: measles, supra note 9, at 893. 45. associated press, measles deaths down globally, newsday, dec. 5, 2008, at a53. 46. update: measles, supra note 9, at 896. 47. see donald g. mcneil, jr., fast-spreading outbreak reveals lower immunization rate in gibraltar, n.y. times, nov. 11, 2008, at d8. 48. update: measles, supra note 9, at 893. 49. parker et al., supra note 10, at447. 124 indiana health law review [vol. 7:117 protected from symptomatic illnessthus increasing the individual's quali­ ty of life, reducing medical care costs, and preventing disability or death. 50 in addition, the comparative costs between vaccination and treatment for the targeted vpd indicate that prevention is far more economical than treatment for a given individual. 51 the secondary benefits of vaccination programs inure to the community at large. a sufficiently high vaccine cov­ erage rate establishes herd immunity2 a term denoting a community's collective resistance to an infectious disease due to the immunity of a suffi­ cient majority of its members. 53 herd immunity generally protects the sus­ ceptible persons within a community both those who have not received a vaccine due to medical contraindication or choice and also those who re­ ceived the vaccine but did not develop immunity in response to it by ar­ resting the transmissions necessary to sustain an outbreak.54 in turn, herd immunity enables the eradication of targeted vpds and the eventual discon­ tinuation of vaccination against them. another secondary benefit of immu­ nization programs is a large-scale reduction in healthcare-related costs. 55 one expert noted that ''we recoup the total cost of [smallpox] eradication in less than two months today."56 during the 2005 measles outbreak in indi­ ana, the estimated cost of containing the outbreak was $167,685 (almost $5,000 per infected patient).57 because most of the costs were borne by public health officials and treating hospitals/8 the financial burden to indi­ ana taxpayers of a statewide epidemic resulting from poor vaccination cov­ erage could easily reach millions of dollars. given the continuing global presence ofvpds and the myriad benefits and efficacy of vaccination programs, mandatory childhood vaccination programs must be continued and improved. such programs help reduce the increasing reintroduction of vpds and may ultimately enable authorities to suspend vaccination for particular diseases worldwide. 59 50. centers for disease control and prevention, general recommendations on immu­ nization: recommendations of the advisory committee on immunization practices (acjp}, 55 morbidity & mortality wkly rep. rr-i5, dec. i, 2006, at i [hereinafter general recommendations on immunization]. 51. calandrillo, supra note 5, at 380 ("[vpds] cost i6 times more in medical-related costs than do the vaccines that prevent those diseases."). 52. general recommendations on immunization, supra note 50, at i. 53. malone & hinman, supra note 3, at 340. 54. see donald g. mcneil, jr., when parents say no to child vaccinations, n.y. times, nov. 30, 2002, at ai [hereinafter when parents say no]. 55. general recommendations on immunization, supra note 50, at i. 56. mark roth, after more than 20 year:s, he's still awaiting aids vaccine, piit. post-gazette, nov. 24, 2008, at ai (referring to savings based on ''present-day treatment costs"). 57. parker et al., supra note 10, at 452. 58. ld. 59. ten great public health achievements, supra note 33, at 247. 2010] mandatory immunization proorams 125 d. increasing numbers of parents resist childhood immunizations despite the demonstrated efficacy of vaccines and mandatory vaccina­ tion programs, a significant number of parents doubt the value and safety of childhood vaccinations. throughout the country, individual parents and vocal advocacy groups resist the efforts of state and local governments to ensure universal vaccination. this upward trend, largely based on fears of vaccine side effects, threatens to undermine the local and global benefits of immunization efforts and to prevent the near-term eradication of certain vpds. 1. the inherent risks of vaccinations while vaccines have been unquestionably beneficial and efficacious, they involve some inherent risks, as do all medical procedures.60 mild local and systemic reactions are common and brief.61 in rare cases, however, inoculation causes severe allergic reactions and other serious adverse ef­ fects.62 it is altogether reasonable for a community to react negatively when a child endures one of the rare severe side effects of vaccination. 63 yet the rarity of these proven adverse effects suggests that they are not the primary source of current parental misgivings. doubts about vaccine safety and their inherent risks are far from new. as early as 1900, the indiana supreme court addressed parental misgivings about mandatory smallpox vaccination in the case blue v. beach. 64 frank blue alleged that ''vaccination in all cases produced a loathsome constitu­ tional disease, which poisoned the blood of the patient, and frequently re­ sulted in death, and that vaccination was not a preventative of smallpox.'.65 five years later, the united states supreme court addressed opposition to 60. see generally centers for disease control and prevention, update: vaccine side effects, adverse reactions, contraindications, and precautions-recommendations of the advisory committee on immunization practices (acip), 45 morbidity & mortality wkly rep. rr-12, sept. 6, 1996 [hereinafter update: vaccine side effects] (describing the common mild and rare severe reactions to commonly-required childhood immunizations). 61. see, e.g., id at 7 (describing studies ofhepatitis b vaccinations that demonstrated similar reactions to placebo injections); id at 22-23 (describing the frequency and duration of local and systemic reactions to dpt vaccinations). 62. see, e.g., id. at 19 (discussing the extremely rare occurrence of anaphylaxis for all types of vaccinalion); lisa greene, two sides unable to bridge gap, st. pe'iersburg times, nov. 24, 2008, at la [hereinafter two sides unable to bridge gap] (discussing shock or brain inflammation in children receiving dpt). 63. cf when parents say no, supra note 54, at al ("sometimes a community is scared when a child is truly harmed by side effects .... "). 64. blue v. beach, 56 n.e. 89 (ind. 1900). 65. /d. ai9l. the court nonetheless upheld the exclusion ofblue's unimmunized son from school as a valid exercise of the regulatory authority delegated to the city by statute. /d. at97. 126 indiana health law review [vol. 7:117 mandatory vaccination in jacobson v. massachusetts, 66 where jacobson­ who had been convicted of failing to abide by a local ordinance requiring smallpox vaccination sought to prove the injurious or dangerous effects of vaccinations. jacobson, much like frank blue, .. offered to prove that vac­ cination 'quite often' caused serious and permanent injury to the health of the person vaccinated.'.67 the court rejected his proffer, holding that allow­ ing jacobson to avoid compelled vaccination based on his fears alone ''would practically strip the legislative department of its function to care for the public health and the public safety when endangered by epidemics of disease.'.68 2. addressing the risks: using risk balancing to design vaccination pro­ grams in the century that followed blue and jacobson, public health officials have acknowledged and mitigated vaccination risks by using risk-balancing to establish immunization requirements.69 using mechanisms such as the vaccine adverse event reporting system, public health officials compare the risks of adverse reactions to vaccination with the risks presented by the vpds at issue and the benefits of universal vaccination, ultimately selecting vaccines for immunization mandates when .. [ v ]accination is safer than ac­ cepting the risks for the diseases these vaccines prevent."70 as the relative risks evolve over time (due to the decreased incidence of a vpd or newly documented adverse reactions), public health authorities change vaccination protocols accordingly.71 the discontinuation of rotashield vaccination in 1999 demonstrated officials' vigilance and willingness to amend vaccina­ tion protocols as risks are discovered.72 this example confirmed that vac­ cination risks are closely monitored through the vaccine adverse event reporting system and that changes to vaccine recommendations are made swiftly when even rare serious side effects tip the relative risk balance.73 66. jacobson v. massachusetts, 197 u.s. 11 (1905). 67. /d. at 36. 68. /d. at 37. 69. see malone & hinman, supra note 3, at 340. 70. update: vaccine side effects, supra note 60, at 2. 71. see, e.g., malone & hinman, supra note 3, at 340 (discussing the replacement of the more efficacious but more dangerous opv with the less efficacious but safer ipv when naturally occurring polio infections ceased in the united states). 72. see centers for disease control and prevention, withdrawal of rotavirus vaccine recommendation, 48 morbidity & mortauty wkl y rep. 1007 (1999). 73. see centers for disease control and prevention, rotavirus vaccinequestions and answers, http://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-faqs.htm (last visited apr. 5, 2009). 2010] mandatory immunization programs 3. misunderstanding the relative risks: are parents afraid of the right threats? 127 despite officials' continuing evaluation of relative risks, many parents still fear immunizations and the systems of administration. these individu­ als likely fail to acknowledge the actual risks ofvpds themselves. as pub­ lic experience with vpds wanes due to the efficacy of immunization programs, many individuals may not appreciate the severity of the diseases and instead focus their concerns on ''misconceptions of vaccine risks."74 as one scholar described this phenomenon, "[ v ]accines are becoming a victim of their success-many individuals have never witnessed the debilitating diseases that vaccines protect against, allowing complacency toward ilnm.u­ nizations to build."75 unsurprisingly, when parents witness the impact of a particular vpd, their aversions to vaccination tend to diminish drastically.76 controversies over the alleged risks of vaccination, which even pervade popular culture, 77 cause many to emphasize "the relative weaknesses and dangers of immunizations, and the systems through which they are adminis­ tered" instead of the still-present dangers presented by vpds.78 unfortu­ nately, the growing controversy over perceived vaccination risks engenders increasing distrust of public health institutions. louise kuo habakus, a spokeswoman for the new jersey coalition for vaccination choice de­ scribed "a huge trust gap between parents and public health officials."79 the coalition petitioned new jersey's legislature in 2008, "demanding the state abandon all mandatory vaccines, including polio, diphtheria and measles.',so the rising tide of popular distrust of vaccines has undoubtedly been fueled by allegations that vaccinations are causally linked to the onset of autism. in 1998, a british medical journal published a study that posited a tentative link between symptoms of autism spectrum disorders (asd) -and the administration of the measles-mumps-rubella (mmr) vaccine.81 unfor­ tunately, the professed uncertainty of this widely controverted study did 74. jennifer s. rota et al., processes for obtaining nonmedical exemptions to state immunization laws, 91 am. j. pub. healrn 645, 645 (2001 ). 75. calandrillo, supra note 5, at 353. 76. see, e.g., when parents say no, supra note 54, at al (reporting on one parent's experiences with whooping cough and her resulting support for pertussis vaccination). 77. see, e.g., lisa greene, do they need the needle?, st. petersburg times, nov. 23, 2008, at la [hereinafter do they need the needle?] (describing a "spat" between celebr­ ities amanda peet and jenny mccarthy over the merits of childhood vaccination). 78. silverman. supra note 6, at 278-79. 79. henry, supra note 35, at 2. . 80. judy peet, shot with controversy: despite protest against n.j. flu vaccine rjjle; deadline nears, star-ledger (newark), dec. 15, 2008, new jersey section, at 11 (report­ ing that the coalition obtained more than 10,000 signatures on its petitions). /d. 81. a.j. wakefield et al., hleallymphnoid-nodular hyperpasia, non-specific colitis, and pervasive developmental disorder in children, 351 lancet 637, 637-41 (1998). 128 indiana health law review [vol. 7:117 little to hinder its still-lingering effects. 82 though the article has even since been retracted in ful1,83 rates of mmr vaccination in geographical pockets of great britain dropped nearly fifteen percent following its original publi­ cation, and speculation regarding the causal linkage continues in the united states. 84 anecdotal testimony abounds in news media, most with a similar tone: "[t]here have been people who have had these shots and then their child is changed forever .... it can't be purely coincidence."85 yet in the absence of more evidence, this post hoc ergo propter hoc reasoning demonstrates a classic logical fallacy regarding causation.86 the propensity to assume causation based on coincidental timing alone allows anti-vaccine advocates to promote and undiscriminating listeners to em­ brace -the specious and possibly non-existent causal link. if a causal rela­ tionship does exist between vaccination and the onset of asd, it seems likely that adverse effect screening efforts would have produced evidence of the relationship, as even the original controversial study posited.87 when rotashield adversely affected only 1 in 10,000 children, the vaccine was pulled from the market.88 dr. offit reasonably suggests that "if vaccines caused something as common as autismoccurring in up to 1 in 150 child­ ren scientists would have realized it by now."89 nonetheless, parents brought the matter before the omnibus autism proceeding (oap) estab­ lished by the vaccine court, which considered as a matter of law whether the causal linkage existed to award damages for vaccine injuries.90 al­ though the oap special masters determined that the parents failed rather markedly to prove causation in each of the first three cases,91 the issue will undoubtedly linger as parents continue to pursue their own litigation.92 82. see steinhauer, supra note 7, at al. 83. retraction--ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, 375 lancet445 (2010). 84. see do they need the needle?, supra note 76, at la. 85. two sides unable to bridge gap, supra note 61, at la. 86. see monroe c. beardsley, thinking straight: principles of reasoning for readers and writers 91 ( 197 5) (describing the causation-related post hoc logical fallacy). 87. wakefield et al., supra note 81, at 641. 88. two sides unable to bridge gap, supra note 62, at la; centers for disease con­ trol and prevention, withdrawal of rotavirus vaccine recommendation, 48 morbidity & mortality wkl y rep. 1007 (1999) [hereinafter withdrawal of rotavirus vaccine]. 89. two sides unable to bridge gap, supra note 62, at la. 90. gordon shemin, note, mercury rising: the omnibus autism proceeding and what families should know before rushing out of vaccine court, 58 am. u. l. rev. 459, 461 (2008). 91. see, e.g., cedillo v. sec'y of health and human serv., no. 98-916v, 2009 wl 331968, at *1 (fed. cl. feb. 12, 2009) ("the numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners' contentions. considering all of the evidence, i found that the petitioners have failed to demonstrate [causation].") (emphasis in original). 92. see, e.g., cnn.com, vaccines didn't cause autism, court rules, http://www.cnn.com/2009/health/02/lllautism.vaccineslindex.html (last visited mar. 14, 2009) (describing one advocacy group's intent to distinguish the rulings from pending cas2010) mandatory immunization programs 129 regardless of whether this ruling will have future positive effects, many parents currently dread the putative adverse effects of vaccinations. such fears gamer more media attention than the diseases they prevent, which can be attributed to parents' comfortable ignorance of the diseases.93 because such fears persist, parents are increasingly seeking exemptions from mandatory childhood immunization laws in many areas of the coun­ try.94 many states have "seen the numbers of schoolchildren with exemp­ tions for vaccines soar[,]" with some communities having exemption rates of up to twenty-five percent.95 e. the harms of mandatory vaccination exemptions: the problem of the commons. public health officials and healthcare professionals believe that the de­ crease in vaccine coverage in populations will lead to a resurgence of vpds in the united states.96 while parents may individually prefer to avoid vac­ cinations for their children, their choices to do so have ramifications beyond their own families. as dr. robert w. tolan succinctly stated, "if you don't vaccinate your child, you're putting my child at risk.'m in 1968, professor ofbiology garret hardin adapted william forster lloyd's analysis of the impact of individually rational choices on the com­ munity as a whole to his own analysis of population control in his renowned essay, "the tragedy of the commons."98 he posited that if an individual can realize a unit of benefit while simultaneously distributing a concomitant unit of detriment over the community's population, the individual's rational choice would be to take that action.99 yet the collective impact of each in­ dividual's rational choice is an unsustainable degradation of the whole: "ruin is the destination toward which all men rush, each pursuing his own best interest in a society that believes in the freedom of the commons."100 his analysis provides a useful framework for examining universal vaccina­ tion and available exemptions. 1. vaccination coverage and herd immunity as a public common attorney kevin malone and public health scientist alan hinman sug­ gested that "a community free of a communicable disease because of a high es). 93. see two sides unable to bridge gap, supra note 62, at la. 94. see steinhauer, supra note 7, at al. 95. shari rudavsky, parents' dilemma: vaccinate kids or not, indianapolis star, nov. 29, 2008, at al. 96. see measles cases up, supra note 8, at a30. 97. henry, supra note 35, at 2. 98. garrett hardin, the tragedy of the commons, 162 science 1243 (1968). 99. id. at 1244. 100. id. 130 indiana health law review [vol. 7:117 vaccination rate can be viewed as a common ... tot for example, if a mother objects to vaccinations and secures an exemption allowing her daughter to attend school unimmunized, she only minimally increases her daughter's risk of infection if the community benefits from herd immunity (the com­ mon). simultaneously, the mother realizes a unit of benefit by avoiding exposing her daughter to the risk of adverse reactions to the required vac­ cines. toz this act of exemption incrementally decreases the vaccination coverage for the community, the maintenance of which is necessary to sus­ tain herd immunity!03 where vaccine coverage is high, this discrete and incremental decrease in coverage (the distributed unit of detriment) is un­ likely to subvert the secondary benefits of mandatory vaccination programs, so the individually rational choice for the mother may well be to avoid vac­ cination. yet the same choice may be individually rational for all parents in the community. the ultimate result of these aggregated individually ration­ al choices would be the destruction of herd immunity and the elimination of the socio-economic benefits of vaccination programs. the common fails as vaccination coverage levels fall below the thresholds necessary to sustain herd ·immunity, 104 leaving the community susceptible to resurgence of vpds. 2. avoiding the tragedy of the public health common through state action pursuant to the inherent authority of its police powers, a state govern­ ment can intervene to change the individual behaviors that may lead to the collapse of the public health common. given the factors that lead to the in­ dividual decisions to seek exemptions, i contend that an outside actor in this case the state government or its extensions can avert the ''tragedy of the commons" in the field of vpds through a combination of three com­ plementary approaches. first, the state can mandate particular vaccinations to ensure a high level of immunity. 105 these mandates should comprise the vpds for which authorities conclude the benefits realized by immunization dramatically outweigh the risks of adverse reactions to the vaccine. although the gov­ ernment may provide for specialized exceptions from these mandates, these 101. malone & hinman, supra note 3, at 339. 102. /d. 103. /d. 104. the necessary thresholds may be easily compromised. for example, epidemiolog­ ical studies suggest that greater than ninety-five percent vaccination coverage is necessary to prevent measles transmission among schoolchildren in a community. sonja s. hutchins et al., vaccination levels associated with lack of measles transmission among preschool­ aged populations in the united states, 1989-/991, 189 j. of infectious diseases 9 (supplement 1), may 1, 2004, at 8108, available at http://www.journals.uchicago.edu/ toc/jid/189/s l. 105. see malone&hlnman, supra note 3, at 339. 2010] mandatory immunization programs 131 exemptions should be available only where the mandates implicate signifi­ cant liberty concerns. second, the state can educate citizens in order to foster consciousness of the commons.106 for the common of herd immunity, deliberate educa­ tional efforts should include programs designed to increase awareness of: (1) continuing threats from vpds; (2) the comparative risks of adverse reactions to vaccines and complications of vpds; (3) the local, national, and global benefits attained through near-universal vaccination coverage; and (4) the direct impact exemptions have on other members of the com­ munity and on global eradication efforts. if successful, these efforts may lead some would-be exemptors to realize the value of the commons, to re­ evaluate the comparative risks, and to choose vaccination over exemption. third, the outside actor may seek to force the internalization of units of detriment that individual community members externalize in reaching their individually rational decisions.107 even if parents have no particular objections to the potential of adverse effects of vaccines, they may choose not to incur the burdens of vaccination because of the cost and time savings realized by securing an exemption instead. state governments. should seek to eliminate that perverse financial incentive by imposing on the deciding parent a financial or otherwise significant burden that captures the externa­ lized costs. iii. the current structure of mandatory immunization programs among tile states the previous section demonstrated the efficacy of vaccinations and immunization programs, proved the continuing need for mandatory immu­ nization programs, and introduced the concept of herd immunity as a public common. this section examines the current structure of state immunization programs, referring to ·specific states' provisions as examples, in order to introduce the various means implemented to address risks to public health. i will describe various state vaccination requirements and enforcement me­ chanisms, as well as the typically available exemptions and their constitu­ tional implications. these descriptions will illustrate the outer limits of states' authorities, highlight successes and failures in vpd management, and provide examples that will guide the subsequent analysis of indiana's immunization programs. 106. cf hardin, supra note 98, at 1245 ("education can counteract the natural tendency to do the wrong thing ... [if] constantly refreshed."). 107. cf id at 1247 (discussing "carefully biased options" to coerce behavior). 132 indiana realm law review [vol. 7:117 a. the primary method of promoting immunization against vpds the authority to act in the interest of public health is vested in the sev­ eral states.108 courts recognize the duty of state legislatures to protect public health pursuant to their police powers, even where executing that duty in­ volves a marginal infringement on individual choices regarding medical treatment, because individual's choices may endanger the public at large.109 pursuant to this authority, state public health officials focus their finite re­ sources on those populations and causes that can be most readily addressed. in part because children readily transmit communicable diseases and subse­ quently expose their families to infection, uo every state had enacted manda­ tory vaccination laws for students entering public school by the fall of 1980.111 these targeted immunization schemes greatly contributed to the reduction in vpd-associated morbidity and mortality over the previous cen­ tury.m some legislatures establish the specific immunization requirements by statute, delineating as a matter of legislative policy which vpds require state intervention at the legislative level. 113 other legislatures delegate the selection of particular vpds for which to require immunization to public health departments at the state or local levels.u4 although the cdc lists twenty-seven diseases as vaccine-preventable, each state requires proof of immunity for only a fraction ofthose for school entry.m states, with feder­ al financial assistance, 116 also endeavor to provide free vaccinations to those children whose parents are unable to afford them. the indiana state de­ partment of health states rather emphatically on its website: "clinics that get vaccines from the government are forbidden by law from denying you vaccinations because you can't pay."117 schools and childcare facilities, in turn, must report their levels of 108. u.s. const. amend. x. see a/sojacohson,l91 u.s. at 37. 109. see b. jessie hill, the constitutional right to make medical treatment decisions: a tale of two doctrines, 8 tex. l. rev. 277, 304 (2008). 110. see henry, supra note 35, at 2. ill. malone & hinman, supra note 3, at 345. 112. silverman, supra note 6, at 277. 113. e.g., conn. gen. stat. ann. § 10-204a (west 2002); kan. stat. ann. § 214.034 (west 2006 & supp. 2008). 114. e.g., mich. comp. laws ann. § 380.1177 (west supp. 2008); miss. code ann. § 41-23-37 (west 2007). 115. for a composite listing of the vaccination requirements in individual states and territories, see centers for disease control and prevention, childcare and school immunizjl­ tion requirements, 3, 2005-2006, available at http://www.cdc.gov/vaccines/vac-genllaws/ downloads/izlaws05-06.pdf (last visited mar. 14, 2009). 116. see malone & hinman, supra note 3, at 343 (discussing federal assistance through the cdc grant program). 117. indiana state department of health, frequently asked questions, http:// www.in.gov/isdh/17205.htm#faq12 (last visited mar. 14, 2009). 2010) mandatory immunization programs 133 vaccination compliance to state authorities, 118 which allows public health officials to track coverage and focus enforcement efforts. many states combine the school-entry vaccination requirements with mandatory school attendance policies to create enforceable protocols that compel parents to comply with immunization or documented exemption requirements.119 in some states, legislators have delegated statutory authority to agencies to enforce mandatory immunization programs against school officials who fail to meet statutory or regulatory requirements.120 ultimately, the efficacy of school-entry requirements depends on the cooperation of state and local entities to execute the program.121 no state's mandatory vaccination pro­ gram is a "fire-and-forget" system that can be ignored once implemented. b. secondary efforts: targeting populations and disseminating information state agencies also devote resources to immunization efforts that school attendance requirements alone could not adequately address. immu­ nization mandates for students alone might leave populations either suscept­ ible to infection or capable ofvpd transmission at social institutions where the impacts may be most critical. to avoid this problem, states may require members of especially susceptible populations, such as hospitalized pa­ tients, to prove immunity or undergo vaccination as adults especially for those nosocomial infections most likely to be transmitted and sustained in hospital settings.122 this requirement helps prevent the incubation and transmission of life-threatening illnesses among the community's most vul­ nerable members. because state immunization requirements for public-school entry fo­ cus on only a small number of the diseases for which vaccines are available, these programs leave decisions regarding the remaining available vaccines to parents of minor children and adults facing immunization decisions. through annually published recommended immunizations schedules, the cdc recommends some vaccinations for general use that are typically not required for public school entry.123 some states inco1p0rate this recom118. e.g., neb. rev. stat.§ 71-1913.01(2) (2003). 119. see, e.g., davis v. maryland. 451 a.2d 107 (md. 1982) (upholding parent's con­ viction on truancy charges when his child was excluded due to a lack of mandatory immuni­ zations). 120. e.g., ind. code ann. § 20-34-4-5 (west 2008). 121. see silverman, supra note 6, at 277-78. 122. see, e.g., ind. code ann. § 16-28-14-3 (west 2008) (requiring the vaccination of all health facility patients against influenza and pneumococcal disease). 123. for the most recently published guidelines, see centers for disease control and prevention, recommended immunization &hedules for persons aged 0-18 years-united states, 2008, 51 morbidity & mortaijty wkly rep. 1 (2008), at ql, available at http:// www.cdc.gov/mmwr/pdf/wklmm5701.pdf. 134 indiana health law review [vol. 7:117 mended schedule into state information dissemination efforts to encourage parents to comply with available, efficacious vaccination options.124 even where immunization for a particular ·disease is not mandatory for school attendance, states may require that parents are at least informed of the bene­ fits and availability of a particular vaccine.125· following a period of lax school-entry requirement enforcement in the atlanta area, the fulton coun­ ty department of health and wellness nursing director demonstrated a fun­ damental understanding of the importance of education in encouraging compliance, explaining that the jurisdiction "will launch programs to edu­ cate principals, superintendents, day care operators and parents about the importance of vaccinations."126 educational programs serve to maximize voluntary vaccination while demonstrating the conscious decisions of state authorities to limit mandatory compliance to those vpds that pose the most egregious risks to the community. c. the available exemptions from mandatory immunization requirements while state governments have the authority under the police power to act contrary to desires of particular individuals in the interest of public health, infringements of personal autonomy are strongly disfavored in our national culture. in the 1891 opinion ofthe united states supreme court in union pacific railroad company v. botsford, 127 justice gray wrote, "no right is held more sacred, or is more carefully guarded by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority oflaw. "128 although state legislation and a feder­ al'rule of civil procedure superseded some portions of botsford, 129 its arti· culation of the primacy of autonomy in the united states survives. the court revisited autonomy infringement in a medical context in. jacobson, closing its opinion by noting that a legislature or board with delegated au­ thority could potentially impose requirements "so arbitrary and oppressive. in particular cases, as to justify the inference of the courts to prevent wrong and oppression."130 the court held that mandatory immunization against smallpox would be a valid exercise of the state's police power unless for a 124. e.g., n.y. comp. cooesr &regs. tit. 10, § 66-1.1 (2008). 125. e.g., ind. code ann. § 2()...34-4-5.5 (west 2008) (requiring confirmation from parents of female students entering sixth grade that they received hpv information from the school). 126. alison young, watching out for your safety and pocketbook, atlanta j.const., nov. 23, 2008, at dl. 127. union pac. r co. v. botsford, 141 u.s. 250 (1891). 128. id. at 251. 129. see fed. r civ. p. 35 (authorizing courts to order compulsory examinations for "a party whose mental or physical condition ... is in controversy ...... ). 130. jacobson, 197 u.s. at 38. 2010] mandatory immunization programs 135 particular individual it could ''be shown with reasonable certainty that he is not at the time a fit subject of vaccination, or that vaccination, by reason of his then. condition, would seriously impair his health, or probably cause death."131 . one may reasonably assume that the court's willingness to defer to states' legislative judgment regarding infringement of autonomy directly relates to the legitimacy, and in some cases urgency, of the public health purpose addressed. 132 the public support for such actions may similarly wax and wane with the immediacy of a known threat. · perhaps recognizing that addressing the threats posed by vpds may require only near-universal immunization coverage, each state and territory allows citizens to secure certain exemptions from vaccination mandates under at least some circums­ tances, 133 thus preserving individual autonomy where practicable. specific available exemptions vary in each state and territory, but they are generally classified as medical, religious, or philosophical. 134 in certain jurisdictions with weakly designed programs, a fourth de facto category emerges: an "exemption of convenience.''135 1. medical exemptions all jurisdictions provide exemptions from mandatory immunization schedules to individuals for whom vaccinations are medically contraindi­ cated.136 vaccine inoculation is medically contraindicated where, in the judgment of a health care professional, the vaccine would be positively de­ trimental to an individual's health beyond minor anticipated adverse ef­ fects. 137 compelled immunization in such a case would be, as the jacobson court noted, "cruel and inhuman in the last.degree[,]"138 and therefore al­ most certainly unconstitutional. in order to qualify for a medical exemption, most states only require parents to present documentation from a physician attesting to the student's medical ineligibility for vaccination.139 some states, however, actually scrutinize the applications and reject some they regard as specious. for ex­ ample, the chief physician for new york city's board of education, dr. 131. /d. at 39. 132. see id. at 27 ("upon the principle of self-defense, of paramount necessity, a com­ munity has the right to protect itself against an epidemic of disease which threatens the safe­ ty of its members."). 133. see calandrillo, supra note 5, at 413. 134. /d. at 412. 135. /d. at413. 136. malone & hinman, supra note 3, at 348. 137. plnkbook,supranote 15,at 17. 138. jacobson, 197 u.s. at 39. 139. daniel a. salmon et al., health consequences of religious and philosophical exemptions from immunization laws: individual and societal risk of measles, 281 jama 47,48 (1999). 136 indiana health law review [vol. 7:117 terry marx, explained that city officials reject "bogus" applications "if they're based on quackery. "140 the availability and approval of medical exemptions lacks the contro­ versy inherent with other types of vaccination exemptions. the absolute need for the availability of medical exemption seems clear from supreme court jurisprudence, 141 as well as from common sense. the only visible battles regarding medical exemptions occur over the propriety of reviewing a medical exemption application within a state's specific statutory or regu­ latory provisions.142 yet i contend that two concerns are conceivable: (1) parents may secure a willing physician's recommendation for exemption without a reasonable or even plausible need for one; and (2) once-present contraindications may recede over time without the granted exemption ex­ piring. 2. religious exemptions a second type of exemption from mandatory immunization programs allows those who assert conflicting religious beliefs to avoid vaccination as a requisite for school attendance, childcare, or hospitalization. religious exemptions are currently available to citizens in forty-eight states.143 al­ though the language of the relevant statutory provisions and their require­ ments varied, three elements commonly appeared. first, some states attempted to limit the number of questionable religious exemptions by re­ quiring the exemptor to be affiliated with a recognized, organized religion; this once-common requirement now appears to remain in effect in only two states, iowa and nebraska.144 a second common element requires the ap­ plicant to aver to sincerely held religious convictions or beliefs.145 this element facially confronts the practice of applicants seeking religious ex­ emptions without truly adhering to a faith system that would be in any way compromised by vaccination. 146 a third element occasionally included by legislatures requires applicants to allege that the tenets of their faith specifi140. donald g. mcneil. jr., worship optional: joining a church to avoid vaccines, n.y. times, jan. 14,2003, at f1 [hereinafter worship optionalj. 141. see jacobson, 197 u.s. at 39. 142. see, e.g., jones v. wyoming st. dep't of health, 18 p.3d 1189 (wyo. 2001) (hold­ ing that the department's denial of a medical exemption due to the applicant's failure to substantiate his claim of a history of reactions to vaccines was not permitted under state law, which required only that the applicant apply and did not provide for discretionary review). 143. rota et al., supra note 74, at 645. 144. iowa code ann. § 139a.8(4)(b) (west supp. 2008); neb. rev. stat. § 71-221(2) (2006). 145. see, e.g., n.y. publiciiealthlaw§ 2164(9)(mckinney2002); del. code ann. tit. 14, § 131 (supp. 2008) (providing the affidavit format necessary for exemption). 146. see generally worship optional, supra note 140, at f1 (describing the author's personal experience with a religion often joined by individuals merely seeking exemptions). 2010] mandatory immunjzation programs 137 cally conflict with immunization.147 this third element, carefully drafted, could serve two laudable purposes. requiring applicants to specify the con­ flicts, rather than alleging them generally, could allow reviewers to evaluate the reasonableness of the applications and thus prevent applicants from seeking exemption with absolute ease. it would also promote reflection by the applicant on both the nature of vaccination and the tenets of his or her faith, perhaps leading some to determine that exemption is not necessary to comport with their particular religious beliefs. unlike medical exemptions, religious exemptions have led to an ex­ tensive body of litigation. despite constitutional guarantees of religious freedom at the federal148 and state149 levels, the united states supreme court has acknowledged that, pursuant to their police powers, states may infringe on aspects of religious observation under certain conditions: "[a ]ctivities of individuals, even when religiously based, are often subject to regulation by the states in the exercise of their undoubted power to pro­ mote the health, safety, and general welfare .... "150 but when developing mandatory immunization programs, legislators and administrators must carefully consider both the free exercise and the establishment clauses of the first amendment to the united states constitution.151 substantial de­ bate continues over whether a free exercise right mandates that states pro­ vide for religious exemption. 152 yet even the seemingly cautious course of allowing for religious exemptions presents some constitutional concern, because the establishment clause might prohibit a state from granting reli­ gious exemptions due to the perceived recognition and promotion of reli­ gion by the state.153 where the majority of individuals in a state must assume the burdens of vaccination costs and potential adverse effects in order to promote public health while a minority escapes these burdens due to professed religious beliefs, the state may simultaneously violate the equal protection clause of the fourteenth amendment and the establish­ ment clause of the first amendment by recognizing religion as a justifica147. see, e.g., mont. code ann.§ 20-5-405(1) {2007) (including a warning of penal­ ties for false swearing); ga. code ann. § 20-2-77l(e) (west 2007) (requiring specific statement that the exemptor's religious tenets conflict with the immunization practice). 148. u.s. const. amend. i. 149. e.g., ind. const. art. i,§ 3 (''no law shall, in any case whatever, control the free exercise and enjoyment of religious opinions, or interfere with the rights of conscience."}. 150. wisconsin v. yoder, 406 u.s. 205, 220 (1972). 151. the first amendment provides that "congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof .... " u.s. const. amend. i. the operation of the due process clause of the fourteenth amendment, u.s. const. amend. xn, § 1, cl. 3, constrains state actions in accordance with the establishment and free exercise clauses. cantwell v. connecticut, 310 u.s. 296,303-04 (1940). 152. see malone & hinman, supra note 3, at 349-50 (surveying the progress of free exercise clause jurisprudence in the context of compulsory immunization). 153. see torasco v. watkins, 367 u.s. 488,495 (1961) (holding that a state government cannot "constitutionally pass laws or impose requirements which aid all religions as against non-believers .... "). 138 indiana health law review [vol. 7:117 tion for differential treatment.154 unfortunately, the constitutional jurisprudence resulting from chal­ lenges under the free exercise and establishment clauses is convoluted at best, leaving state legislatures with the difficult task of navigating troubled waters with little guidance. in lemon v. kurtzman,155 the u.s. supreme court considered whether pennsylvania and rhode island violated the es­ tablishment clause by providing financial support to parochial· schools and teachers. calling upon the "cumulative criteria developed by the court" in its history of cases, chief justice burger summarized a three-part test for determining if a state policy violates the establishment clause: "first, the statute must have a secular legislative purpose; second, its principal or pri­ mary effect must be one that neither advances nor inhibits religion; finally, the statute must not foster an excessive government entanglement with reli­ gion."is6 applying this test to a state's provision of religious exemptions shows a potential conflict with the second and third prongs. while a clear secular purpose of the provision may be the constitutional preservation of mandato­ ry immunization programs by allowing for free exercise of religion, the primary· effect of the exemption provision might be to advance religion by creating benefits (through riskand cost-avoidance) for those of certain faiths. in addition, the threshold for "excessive government entanglement with religion"157 under the third prong may be lower than one would initial­ ly perceive.158 the lemon court admitted that ''the line of separation ... is a blurred, indistinct, and variable barrier depending on all the circumstances of a particular relationship .... "159 it ultimately based its finding of an im­ permissible degree of entanglement under the circumstances in large part on the inevitable political involvement of religious advocates and secular op­ ponents: 154. similar reasoning led the mississippi supreme court to strike down the mississip­ pi provision allowing religious exemptions from school-attendance vaccination require­ ments. see brown v. stone, 378 so.2d 218,223 (miss. 1979) ("[w]e hold that the provision providing an exception from the operation of the statute because of religious belief is in vi­ olation of the fourteenth amendment to the united states constitution and therefore is void."), cert. denied, 449 u.s. 887 (1980). accord lemon v. kurtzman, 403 u.s. 602, 612 (1971) ("a given law might not establish a state religion but nevertheless be one "respect­ ing" that end in the sense of being a step that could lead to such establishment and hence offend the first amendment."). 155. lemon v. kurtzman, 403 u.s. 602 (1971). 156. lemon, 403 u.s. at 612-13 (internal citations and punctuation omitted). 157. walz v. tax comm'n, 397 u.s. 664, 674 (1970). 158. in walz, the court noted that "[t]he test is inescapably one of degree[,]" 397 u.s. at 674, and held that new york's real estate tax exemption for church properties was consti­ tutional. id at 680. the lemon court characterized the walz holding as "tend[ing] to con­ fine rather than enlarge the area of permissible state involvement with religious institutions by calling for close scrutiny of the degree of entanglement involved in the relationship." 403 u.s. at614. 159. lemon, 403 u.s. at 614. 2010] mandatory immunization programs partisans of parochial schools ... will inevitably champion this cause and promote political action to achieve their goals. those who oppose state aid, whether for constitutional, religious, or fiscal reasons,· will inevitably respond and employ all of the usual political campaign techniques to prevail. candidates will be forced to declare and voters to choose ... ordinarily political debate and division, however vi­ gorous or even partisan, are normal and healthy ma­ nifestations of our democratic system of government, but political division along religious lines was one of the principal evils against which the first amendment was intended to protect. 160 139 :' ·" in the end, no clear standards exist that either mandate or prohibit the provi­ sion of religious exemptions from mandatory immunization practices. pre-·. vious state decisions, such as the mississippi decision brown v. stone, 161 suggest that states have no constitutional mandate to provide religious ex­ emptions, but the supreme court has yet to directly address whether they are permissible where offered.162 dissenting from the majority in a case arising in indiana, justice rehnquist characterized the apparently conflicting mandates of the estab­ lishment and free exercise clauses: "[a] cause of the tension is overly ex­ pansive interpretation of both clauses . . . . [t]he court has constantly narrowed the channel between the scylla and charybdis through which any state or federal action must pass in order to survive constitutional scruti­ ny."163 one trend is at least clear; where plaintiffs have challenged statuto­ ry exemptions requiring that the individual's claimed religion be state­ recognized, courts have held the provisions unconstitutional as violative of the establishment clause.164 beyond the infirmity of that element, what 160. lemon, 403 u.s. at 622. 161. brown v. stone, 378 so.2d 218 (miss. 1979) (holding that a religious exemption from compulsory vaccination would discriminate against the majority of students whose parents do not seek exemptions by exposing them to health risks), cert. denied, 449 u.s. 887 (1980). 162. silverman, supra note 6, at 281. 163. thomas v. review bd. of the ind. employment div., 450 u.s. 707, 721 (1984) (rehnquist, j., dissenting)(emphasis in original). 164. see, e.g., sherr v. northport-e. northport union free sch. dist., 672 f. supp. 81, 89 (e.d.n.y. 1987) ("[l]imitation of a religious exemption from vaccination to those who are members of recognized religious organizations is blatantly violative of that first amendment guarantee.") (emphasis added). 140 indiana health law review [vol. 7:117 little guidance these precedents afford may suggest that religious exemp­ tions from immunization mandates are constitutionally suspect. state laws requiring averment of sincere religious beliefs or descriptions of conflicting tenets are facially neutral, but any threshold for conflict or sincerity below which exemption applications can be denied may lack justiciable standards for administrators.165 if state or local administrators cannot constitutionally question even a feigned shibboleth, then the sincere belief and conflicting tenets elements lack much of their intended substance.166 to illustrate the point, consider dr. walter p. schilling, a new jersey chiropractor who runs the congregation of universal wisdom, who touts his "5,520 members, mostly families wanting to avoid vaccination, in 28 states."167 although the question of sincerity could conceivably be evaluated based on the appli­ cant's conduct/68 the administrative burden of such evaluation in each case would be immense, if not prohibitive. the lemon court noted that the "political divisiveness related to reli­ gious belief and practice is aggravated" where demands are likely to grow over time. 169 because parents increasingly fear vaccines and oppose forced immunization, the number of religious exemptions sought is likely to in­ crease, thus forcing the issue into the political arena especially in states where the only means for parents to avoid vaccinations is a religious ex­ emption.170 so while the applicable test for constitutionality of state­ provided religious exemptions from mandatory immunization protocols is uncertain, 171 it appears that any statute providing religiously-based exemp­ tions is not immune to constitutional attacks. yet, because there is no suffi­ cient alternative to mandatory vaccination to combat and eradicate vpds, an unenviable task remains for legislators. they must either (1) develop a scheme that recognizes free exercise of religion without running afoul of establishment constraints, or (2) determine as a matter of policy that, under 165. see, e.g., si1vennan, supra note 6, at 287-88 (discussing a holding of the u.s. dis­ trict court of the northern district of new york that, despite inconsistencies in behavior and testimony and a lack of knowledge of the church's organization and tenets, a would-be ex­ emptor still showed the requisite sincerity necessary to be exempted from mandatory immu­ nizations). 166. see id. at 288 (discussing the power of''magic words"). 167. worship optional, supra note 140, at fl. 168. see, e.g., id. (quoting the chief physician of new york city's board of education saying, "if someone were really and truly part of this church and upheld its beliefs, that would pass the test. but only if somebody really obeyed this. that means they wouldn't treat their kid for asthma, wouldn't take their kid for an appendectomy."). 169. lemon, 403 u.s. at 623. 170. see worship optional, supra note 140, at f1 ("parents opposing vaccination often apply for religious exemptions when they cannot get philosophical or medical ones .... "). 171. see malone & hinman, supra note 3, at 349-50 (discussing the judicial reduction of strict scrutiny in the free exercise context, congress's subsequent passage of the religious freedom restoration act (rfra) of 1993, and the u.s. supreme court's subsequent finding that rfra was unconstitutional). 2010] mandatory immunization programs 141 the supreme court's reasoning of wisconsin v. yoder, 172 the public health goals sought justify the abandonment of a religious exemption altogether. 3. philosophical (personal belief) exemptions the third de jure exemption from mandatory immunization allows those with philosophical or personal beliefs that conflict with vaccination to avoid inoculation for their children. such philosophical exemptions are currently available in twenty states, 173 though various accountings of states allowing such exemptions may differ because some statutes and regulations allow for personal belief exemptions without necessarily delineating be­ tween religious and philosophical beliefs.174 in january of 2008, new jer­ sey became the most recent state to consider adding a philosophical exemption when assemblywoman charlotte v andervalk introduced a bill proposing conscientious exemptions from mandatory immunization. 175 in states without exemptions for personally-held but not religious be­ liefs, available religious exemptions may result in de facto philosophical belief exemptions. 176 this situation does not obtain if religious exemptions are scrutinizedthat is, if exemptions are denied because the applicant's stated reasons for seeking exemption do not arise from religious teachings or belief. 177 but any delineation between religion and philosophy is un­ clear, 178 leaving administrators in difficult positions when determining whether to grant a religious exemption or deny the application as philosoph­ ically-based. if religious exemptions are not policed that is, if they are granted without review for sincerity and source of opposition to vaccination then exemptors may file under religious exemption provisions even with­ out genuine religious objections. 179 some state officials in indiana suspect 172. yoder, 406 u.s. at 215 ("[o]nly those interests of the highest order and those not otherwise served can overbalance legitimate claims to the free exercise of religion."). 173. national conference of state legislatures, school vaccination exemption laws, http://www.ncs1.org/programslhealth/schoolexemplawschart.htm (last visited mar. 15, 2009). 174. e.g., cal. health & safety code § 120365 (west 2007) (requiring "a letter or affidavit stating that the immunization is contrary to his or her beliefs" without reference to the religious or philosophical source thereof). 175. a.b. 260, 213th leg., 1st ann. sess. (n.j. 2008). 176. see worship optional, supra note 140, at fl. 177. see, e.g., farina v. bd. ofeduc. of city ofnew york, 116 f. supp. 2d 503, 505 (s.d.n.y. 2000) (denying mother's exemption request because the stipulated source of her objection was secular and not religious: "oh, come on, i'm catholic .... it's really not a reli­ gious belief, it's a personal belie£"). 178. see malone & hinman, supra note 3, at 352-53 ("decisions by the u.s. supreme court ... indicate that a bright line may not always exist between the religious and the phi­ losophic and that at least some amount of philosophic opposition to vaccination may rise to the level of being religious .... "). 179. see calandrillo, supra note 5, at 415-16 (arguing that officials should be able to inquire into sincerity of religious objections to prevent the erosion of the intent of the ex142 indiana health law review [vol. 7:117 that a number of parents are exploiting this approach, regardless of religious beliefs. 180 ultimately, the unfettered availability of a de jure or a de facto philosophical objection renders a mandatory. immunization program a vo­ luntary program. absent significant administrative hurdles in applying for an exemption :from the designated official, nothing prevents the parents of every child :from seeking and securing exemptions. only a personal belief in the efficacy and value of vaccinations then serves to compel parents to comply with the immunization requirements. unfettered availability of personally-held belief and philosophical ex­ emptions could dramatically and dangerously expand the number of indi­ viduals who go unimmunized. in 1998, in states where such exemptions were available, "parents [were] taking advantage of such exemptions with growing regularity; and in states offering both exemptions, the number of philosophical exemptions far exceed[ed] the number of religious and medi­ cal exemptions."181 such an increase in exemptions can render communi­ ties with even a marginally increased proportion of unvaccinated individuals susceptible to vpd outbreaks. 182 more recent reports also show an increase in claimed philosophical exemptions, particularly among geo­ graphically-clustered groups.183 geographic clustering of exempt popula­ tions is of particular concern, because the pockets lack the herd immunity necessary to protect those who cannot be vaccinated and those with wea­ kened immune systems within the community.184 to date, state and nation­ al reports have aggregated vaccination coverage data at the state level, potentially preventing the detection of geographically-clustered groups that tend to increase the risk ofvpd outbreaks.18s 4; exemptions of convenience lax enforcement or ambiguous language in statutes and regulations can lead to the creation of a de facto fourth category of mandatory immuni­ zation program exemptions: exemptions of convenience.186 parents, for emptions ). see also silvennan, supra note 6, at 285 ("[t]he lack of statutory authority ... to challenge claims based on religious beliefs. or the relaxed enforcement of existing rules, allows virtually any applicant in such states to gain exemption.''). 180. rudavsky, supra note 95, at ai. · 181. silverman. supra note 6, at 284 (citing daniel r. feikin et al., individual and community risks of measles and pertussis associated with personal exemptions to immuni­ zation, 284 jama 3145,3147 (2000)). 182. see update: measles, supra note 9, at 894 (reporting non-immunized patient data). 183. see chris joyner, vaccination schedules: safety concerns surface on both sides of debate, usa today, oct. 22,2008, § b (life), at 11. 184. see when parents say no to child vaccinations, supra note 53, at at. 185. centers for disease control and prevention, national, state, and local area vac­ cination coverage among children aged 19-35 months-united states, 2007, 51 morbidity & mortalitywklyrep. 961 (2008). 186. see when parents say no, supra note 54, at al (noting that in states such as cali­ fornia it may be easier to exempt than comply with vaccination schedules). 2010] ~datory~~tionprograms 143 example, may claim exemptions for their children simply "because it was easier to do so than to go to the effort of finding [their child's] immuniza­ tion record."187 one 2001 study noted that "[a]n inverse relationship was observed between the complexity of requirements and the proportion of children claiming exemptions."188 as daniel a. salmon, a researcher at the johns hopkins school of public health, succinctly stated, "people take the path of least resistance .... "189 these statements underscore the need for rigorous screening procedures to limit exemption availability to. those for whom states designed the exemptions. exemptions of convenience have a direct and deleterious impact on herd immunity and vpd resistance within a community. commenting on a 2006 study comparing vpd incidence and exemption prevalence published in the journal of the american medical association, dr. offit noted that "states with easy-to-obtain philosophical exemptions had twice as many children suffering from pertussis ... than states with hard-to-obtain philo­ sophical exemptions."190 states may justifiably decide to make non­ medical exemptions available to their citizens in the interest of personal autonomy, but no reasonable arguments in favor of allowing parents to avoid vaccinating their children for convenience alone can be sustained. while detailed scrutiny of applications may be cost prohibitive, the com­ plexity of the application process alone may offer some level of public health protection.191 more complex processes should not deter a parent with sincerely-held beliefs opposed to vaccination, and the complexity of a process that nonetheless yields exemptions for those with sincere beliefs cannot be said to significantly infringe upon autonomy. states should therefore design their processes for obtaining exemptions to ''properly re­ flect the importance that society has accorded immunization through its laws."192 n. analysis of indiana's mandatory immunization programs the foregoing sections provide the necessary background and analyti­ cal framework for a principled examination of indiana's mandatory immu­ nization program. this section first explores the current structure of indiana's program, comparing it to those of other states in order to assess its strengths and weaknesses. the remainder then recommends changes to sta187. calandrillo, supra note 5, at 418 (quoting alan r. hinman et al., childhood immunization: laws that work, 30 j.l. med. & ernics 122, 125 (2002)). 188. rota et al., supra note 74, at 647. 189. when parents say no, supra note 54, at ai. 190. offit, supra note 37, at a10. 191. see rota et al., supra note 74, at 647 (noting that none of the states with the most complex category of application requirements had a high degree of exemption). 192. /d. at 648. 144 indiana health law review [vol. 7:117 tutory and regulatory provisions that would increase the program's efficacy and constitutionality. a. the current structure of indiana's mandatory immunization program indiana's mandatory immunization provisions share common charac­ teristics with the majority of other states. i will first examine indiana's primary and secondary methods of ensuring a high vaccination coverage rate. then i will discuss its available exemptions. at each point, i will as­ sess the strengths and weaknesses of the state's provisions. 1. primary immunization efforts: efficient targeting of populations recall that the first means for avoiding the tragedy of the public health commons is for a state to intervene and compel a particular behavior.193 indiana employs this method by mandating immunization against some vpds, focusing its vaccination efforts on school-aged children. this ap­ proach maximizes efficiency for state and local health officials by targeting a key population in the transmission ofvpds. the cohort of children enter­ ing school each year can be easily identified, because indiana law requires the attendance of all children in specific age ranges, 194 as well as the main­ tenance of attendance records. 195 targeting these identifiable populations obviously increases aggregate vaccination coverage as children mature and new identifiable populations enroll. in contrast to many states that base mandatory immunization programs strictly on school attendance, indiana statutorily requires every child residing in indiana to be immunized against diphtheria, pertussis, tetanus, measles, rubella, polio, and mumps. 196 this provision applies to children other than those entering public schools such as those who will be home-schooled thus laudably avoiding under­ inclusion that could lead to unimmunized clusters of children within partic­ ular communities. indiana's statutory provisions confer significant authority on an ad­ ministrative agency to develop and execute the mandatory vaccination pro­ gram. one key provision authorizes the state department of health to "expand or otherwise modify" the required immunizations as "medical in­ formation becomes available that would warrant the expansion or modifica­ tion in the interest of public health."197 this provision allows for the administrative addition of a vaccination requirement militated by public health concerns without the necessity of legislation. the provision may 193. see discussion supra part ii.e.2. 194. ind. code ann.§ 20-33-2-6 {west 2008). 195. ind. cone ann.§ 20-33-2-20 (west supp. 2008). 196. ind. code ann.§ 20-34-4-2(a) {west 2008). 197. ind. code ann.§ 20-34-4-2(c) {west 2008). 2010] mandatory immunization programs 145 also allow for the discontinuation of a vaccination requirement in the event of domestic eradication, although the "otherwise modify" language has not yet been construed to either obviate or require the need for legislative amendment. rather than specifying how or when the immunizations are administered, the statute also delegates the authority for developing these rules to the state department of health.198 the agency therefore has the au­ thority to adapt immunization protocols in response to changing policy con­ siderations, such as updated recommended vaccination schedules. this distribution of power also shields decision-makers from the direct political pressures often applied to elected officials, thus reducing the likelihood of a court finding excessive entanglement between legislators and religious ad­ vocates.199 indiana code further mandates that schools notify parents of immuni­ zation requirements upon school enrollment.200 if a parent does not provide a written statement attesting to the student's immunizations, accompanied by certificates or documents provided by the physician administering the vaccines,201 then the student will not be allowed to attend school beyond the first day without a waiver.202 the allowed waivers provide for extenuating circumstances and should serve to eliminate typical inconveniences from being realistic barriers to compliance. 203 in. order to reach the maximum number of citizens who are particular­ ly susceptible to vpd transmission, indiana also statutorily requires immu­ nizations for children attending state-licensed child care facilities and young adults attending state colleges and universities in indiana. a childcare facil­ ity licensed in indiana must ensure that each child cared for in the facility has received age-appropriate immunizations. 204 these provisions allow public health officials to identify and reach specific populations of children before they are subject to school-entry requirements but while they are non­ etheless highly susceptible to infection and prone to transmission to other children and their families. at the other end of the youth spectrum, indiana law ensures that students both those from other states and also those not already reached by the state's school-entry requirementsmatriculating at state higher education institutions are immunized against diphtheria, teta­ nus, measles, mumps and rubella.205 a separate provision requires a certifi­ cate of immunization against meningococcal disease for incoming 198. ind. code ann.§ 20-34-4-2(d) (west 2008). 199. see supra text accompanying notes 155-60. 200. ind. code ann. § 20-34-4-3(a) (west 2008). 201. see ind. code ann. § 20-34-4-4(b) (west 2008) (requiring the physician who administers the vaccines to give a certificate or other documentation to the individual who presented the student for immunization). 202. ind. code ann. § 20-34-4-5 (west 2008). 203. see id. 204. ind. code ann. § 12-17.2-4-18.1 (west 2007). 205. ind. code ann. § 21-40-5-2 (west 2008). 146 indiana health law review [vol. 7:117 students.z06 2. secondary immunization efforts: educating the public about vpds state actors may also intervene in the tragedy of the public health commons by educating individuals about the consequences of immuniza­ tion decisions.207 indiana already incorporates some educational provisions into its immunization laws. for example, middle schools must provide par­ ents of female children entering the sixth grade with information dissemi­ nated by the state department of health concerning the link between hpv and cervical cancer.208 indiana also requires its higher educational institu­ tions to provide students intending to enroll with.information about the risks of and available vaccination against meningococcal disease.209 these pro­ visions directly support public health goals and serve as useful models in considering the incorporation of further educational components into our immunization programs. 3. enforcement of mandatory immunization requirements in indiana schools must report to the state and local health departments data re­ garding the number of students who have complied with the immunization requirements and the number of students who have not demonstrated their immunity to listed vpds.z10 in order to enable and promote enforcement of the immunization mandates, indiana empowered the state department of health to commence civil actions against schools failing to enforce immuni­ zation requirements or to comply with reporting requirements.211 the de­ partment may even seek a writ of mandamus to compel compliance.212 in concert, these provisions allow for the periodic auditing of records, review of established procedures, and corrective actions when the systems stall or fail. indiana therefore enjoys the statutory and regulatory frameworks ne­ cessary to hopefully avoid, but certainly react to, lax enforcement situations like that experienced in atlanta in 2008.213 206. ind. code ann. § 21-40-5-5 (west 2008). 207. see discussion supra part ii.e.2. 208. ind. code ann.§ 20-34-4-3(c) (west 2008). 209. ind. code ann.§ 21-40-5-5(a) (west 2008). 210. ind. code ann.§ 20-34-4-6(a) (west 2008). 211. ind. code ann. § 20-34-4-5(d) (west 2008) (applying to public schools); ind. code ann.§ 21-40-5-8 (west 2008) (applying to postsecondary institutions). 212. see ind. code ann.§ 34-27-3-1 (west 1999). 213. see generally alison young, spotlight: vaccination law fails to touch all kids, atlanta j.--const., oct. 26, 2008, at a1; alison young, watching out for your safety and pocketbook, atlanta j.--const., nov. 23, 2008, at d1 (describing poor vaccination coverage). 2010] mandatory immunization programs 147 4. the mandatory immunization exemptions available to hoosiers in 1900, the indiana supreme court first articulated the authority of the state pursuant to its police power to compel a student to be immunized or excluded during a smallpox outbreak: "[a]mong all of the objects to be secured by governmental laws, none is more important than the preserva­ tion of the public health; and an imperative obligation rests upon the state ... to take all necessary steps to promote this object."214 the court did qualify the extent of this power: "it is not, however, without limitation, and it cannot be invoked so as to invade the fundamental rights of a citizen."215 because compelled vaccination could infringe on fundamental rights and autonomy, indiana provides exemptions in two circumstances. a. exemptions in the case of medical contraindication first, indiana observes the limitation suggested by the united states supreme court in jacobson that forced inoculation against medical indica­ tions would be "cruel and inhuman to the last degree[,]'o216 by statutorily providing for medical exemptions in conjunction with each of its immuni­ zation requirement provisions. for example, individuals do not have to un­ dergo vaccination to meet school-entry requirements when "a physician certifies that a particular immunization required ... is or may be detrimen­ tal to a student's health.'o217 the physician's certification serves as an ex­ emption for the duration of the medical contraindication, but should expire when "immunization is found no longer detrimental to the student's health.''218 a similar exemption allows college students to avoid immuniza­ tion requirements "[i]f a health care provider makes a written statement in­ dicating the nature and probable duration of a medical condition or circumstances that contraindicate an immunization, identifying the specific vaccine that could be detrimental to the student's health.',a19 such an ex­ emption endures only for the duration of the contraindication: "if the stu­ dent's medical condition or circumstances subsequently permit immunization, the exemptions granted by this section terminate and the stu­ dent shall obtain the immunizations ... .'.22° the language of both provi­ sions clearly demonstrates the legislature's intent to limit medical exemptions to necessary circumstances. unfortunately, reports and records aggregate claimed medical exemp214. bluev. beach. 56 n.e. 89,92 (ind. 1900). 215. id at 92 (quoting statev. gerhard, 44 n.e. 469,473 (ind. 1893)). 216. jacobson, 197 u.s. at 39. 217. ind.codeann. § 20-34-3-3 (west2008). 218. /d. 219. ind. code ann.§ 21-40-5-4 (west 2008). 220. /d. 148 indiana health law review [vol. 7:117 tions at the state level without tracking data regarding the underlying medi­ cal contraindications.221 although an exemption may terminate as a matter of law when immunization is no longer contraindicated,222 absent frequent review of compliance records, a stale medical exemption will continue to allow the attendance of an unimmunized student despite the lack of a condi­ tion justifying the risks she endures and poses. these considerations indi­ cate a potential for abuse of the medical exemption, especially where sufficient data regarding geographic concentrations of medical exemptions or anomalous numbers of exemption certifications produced by specific providers are not tracked. b. exemptions in the case of conflicting religious beliefs indiana's other available exemption type allows for the avoidance of vaccinations due to religious conflicts. the language of the religious ex­ emption statutes is broad and lacks common qualifying elements seen in other states: "except as otherwise provided, a student may not be required to undergo ... immunization ... when the child's parent objects on reli­ gious grounds."223 notably absent are requirements for the exemptor to aver to the sincerity of her religious beliefs and to describe in detail her faith's conflicting tenets. rather, in order to secure the exemption, a hoosier need only make her objection in a signed writing that she delivers to a school official or to the official providing the vaccination.224 the sta­ tutes also omit any language regarding the evaluation including the poten­ tial denialof exemption applications. the phrasing of the religious exemption provisions would seem to al­ low any parent or student who claims a religious exemption to successfully obtain one. facially, these statutes do not appear to contemplate a process of application and approval, but rather an unreviewable act of declara­ tion.225 indiana's statutory scheme thus appears excessively permissive, rather than narrowly tailored so as to ensure that the exemptions are only provided to those whose autonomy in a religious sense actually would be infringed upon by vaccination mandates. accordingly, the system al­ lows hoosiers to secure de facto personal belief exemptions and exemp­ tions of convenience,226 in addition to the religious exemptions likely 221. rudavsky, supra note 93, at a9. 222. see, e.g., ind. code ann.§ 21-40-5-4 (west 2008). 223. ind. code ann. § 20-34-3-2(a) (west 2008). see ind. code ann. § 21-40-5-6 (west 2008) for essentially identical language involving students at higher education institu­ tions. 224. § 20-34-3-2(b); § 21-40-5-6(b). 225. cf jones v. wyoming st. dep't ofhealth, 18 p.3d 1181 (wyo. 2001) (holding that denial of a medical exemption was not permitted under a state law that required only that the applicant claim the exemption and did not provide for discretionary review). 226. see discussion supra part iii.c.3-4. 2010] mandatory immunization programs contemplated by the legislature. b. recommended changes to indiana's mandatory · immunization provisions 149 having mapped out the current structure of indiana's mandatory im­ munization program, including its strengths and infirmities in light of the considerations introduced in preceding sections, the remainder of this note proposes changes to the program to increase its efficacy. i will begin by discussing the state's strong record of maintaining the hoosier public health common. i will then propose changes that indiana's legislators and admin­ istrators can easily make to improve on that record while accommodating autonomy interests and assuaging fears. 1. the current state of vaccination coverage and exemption prevalence according to the indiana state department of health, vaccine cover­ age levels for hoosier students enrolled in the reporting schools reached ninety-six percent during the most recent year for which data have been published.227 the indianapolis star recently reported that "(i]n recent years in indiana, the numbers of medical and religious exemptions have remained stable, at less than 1 percent each.'.n8 if these statistics accurately depict vaccination coverage and the prevalence of claimed exemptions throughout indiana, then parents, school administrators, and public health authorities have done a remarkable and commendable job furthering the health of hoosiers and, by extension, communities around the globe. unfortunately, these aggregate percentages may camouflage both shortcomings in vaccination coverage in specific schools or communities and also significant increases in exemptions secured. although every school must annually file written reports with the state and local depart­ ments of health,229 only "[n]inety-four percent of public schools and sixty­ eight percent of private schools reported complete immunization data[;]" and the aggregate report excluded data from schools reporting incomplete data. 230 these gaps in reporting may fail to capture and depict low levels of vaccine coverage in the schools whose data were not received or analyzed. this oversight may have particular significance due to the likelihood of clusters of unimmunized students within a given community or school.231 these unidentified clusters lead to significant risks of outbreak susceptibili227. kristin ryker, indiana state department of health, 2006-2007 school year (2007), http://www.in.gov/isdh/21032.htm#levels (last visited mar. 14, 2009). 228. rudavsky, supra note 95, at at. 229. ind. code ann. § 20-34-4-6 (west 2008). 230. ryker, supra note 227. 231. seejoyner,supranote 183, at 11. 150 indiana health law review [vol. 7:117 ty, even where aggregate coverage has been high.232 exemption prevalence; as reported on by the indianapolis star,233 may likewise be subject to un­ realistic characterization when statistics are viewed in aggregate form. while the exemption percentage may have remained around one per­ cent, the actual number of religious exemptions reported by school systems for children entering kindergarten has more than doubled in recent years?34 during the same period, the actual number of children entering kindergarten has varied less than fifteen percent.235 accordingly, a "stable" one percent may yet encompass dramatic increases in exemptions sought, following alarming trends in other states.236 although the aggregate vaccination cov­ erage statistics seem favorable, indiana's demonstrated susceptibility to outbreaks,237 viewed in light of rising anti-vaccine activism throughout the nation, suggests that its mandatory immunization provisions should be revi­ sited and updated. the following minor changes may help indiana develop and maintain strong levels of vaccine coverage and herd immunity without significantly infringing on individual autonomy, risking unconstitutional waters, or alienating an already distrusting public. 2. amending the religious exemption statutory provisions as noted above, the ease with which any individual can secure a reli­ gious exemption in indiana threatens to render the entire mandatory immu­ nization scheme merely voluntary.238 as more parents distrust public health authorities and the vaccines they advocate, they will be more likely to seek refuge in whatever exemptions are available. because indiana's religious exemption provisions allow for exemptions of convenience and de facto philosophical belief exemptions, far more people can successfully avoid immunizations for their children than the legislature likely intended when it enacted the religious exemption provisions. assuming the indiana general assembly provided for religious ex­ emptions to prevent infringing upon hoosiers' free exercise of religion in accordance with our state and federal constitutions, the exemption should reach only those individuals whose religious faith and practices would be undermined by vaccination mandates. yet a government can hardly in­ fringe upon beliefs that an individual actually does not hold. the statutory provisions should thus be amended to ensure a narrow tailoring which al232. parker et al., supra note 10, at 447. 233. rudavsky, supra note 95, at al. 234. ld. at a9 (reporting an increase from 272 in the 2001-2002 school year to 557 in the 2007-2008 school year). 235. see id. (showing an annual average of84,034 during this period). 236. see id. at al; see also steinhauer, supra note 7, at al. 23 7. see, e.g., parker et al., supra note 10, at 44 7 (describing a 2005 measles outbreak). 238. see discussion supra part iv.a.4.b. 2010] mandatory immunization programs 151 lows. religious exemptions, to the greatest degree practicable, only for those with sincerely held beliefs that would actually be infringed upon. three easily drafted provisions would enable significant progress to­ ward this goal first, the exemption should be available only upon the ap­ plicant's averring to the sincerity of her religious beliefs in a notarized affidavit. such a provision could be modeled on the affidavit set forth in the corresponding delaware statute, which requires statements swearing or affirming a belief in a supreme being, affirming the sincerity of the belief, and denying that the belief is derived from "a political, sociological or phi­ losophical view of a merely personal moral code. "239 second, the exemption should be conditioned upon the applicant's at­ taching a letter or document detailing those specific tenets of faith with which vaccination conflicts. new york provides for such a system in its statutory and regulatory provisions. that state's vaccination mandates do "not apply to children whose parent, parents, or guardian hold genuine and sincere religious beliefs which are contrary to the practices [of immuniza­ tion]."240 that statute further provides for administrative adoption of''rules and regulations to effectuate [its] provisions and purposes.'.241 pursuant to that authority, the new york state department of health delegates the power to school officials to require parents seeking a religious exemption to provide supporting documentation.242 indiana should incorporate similar provisions delegating such authority to the state and local departments of health and, ultimately, to local school officials. third, either or both of the preceding provisions should be accompa­ nied by a warning regarding a penalty for false swearing. montana's reli­ gious exemption provision simply states: "a person who falsely claims a religious exemption is subject to the penalty for false swearing provided in 45-7-202.''243 a similar warning appended to indiana's religious exemption provisions could discourage disingenuous use of the exemption by promot­ ing honest reflection or evoking fear of reprisal for exploitation of a legal loophole. care should be taken, however, to ensure that these suggested amendments do not establish or deny exemptions for any particular religion or faction. by drafting the provisions with neutrality toward particular reli­ gious beliefs, legislators can likely limit constitutional challenges under the establishment clause.244 further, would-be exemptors should be required to apply for religious exemptions instead of simply claiming them by providing letters to caregiv239. del. code ann. tit. 14, § 131 (supp. 2008). 240. n.y. public health law§ 2164(9) (mckinney 2002). 241. /d. at §2164(10). 242. n.y. comp.codesr.&regs. tit.lo, § 66-1.3 (2009). 243. mont. code ann. § 20-5-405 (2007). the referenced penalties include a fine, confinement in jail for up to six months, or both. mont. code ann. § 45-7-202 (2007). 244. see supra text accompanying note 164. 152 indiana health law review [vol. 7:117 ers or school officials. this would afford an opportunity for state supervi­ sion of religious exemption approvals. the amended statutes could identify the agency or agencies authorized to receive, review, and grant exemption applications, preferably even delegating authority to those agencies to deny fraudulent applications and providing for both administrative and judicial review for denied applicants. the agencies receiving this delegated authori­ ty could then promulgate regulations describing the methods of evaluation and the minimum standards for approval, thus informing the public of the means for securing a desired exemption and appealing a denied application. yet even without the legislature creating denial authority or the exercise of such authority, the added complexity afforded by the three suggested provi­ sions will likely discourage the use of the religious exemption for conveni­ ence or for de facto personal belief exemptions based on feigned religious beliefs. 245 by contrast, where parents or college students have genuine reli­ gious beliefs which conflict with immunization practices, they would likely be undaunted by an administrative application procedure with de minimis costs. accordingly, these simple statutory amendments would allow the state to intervene and prevent a portion of the behavior leading to the trage­ dy of the public health common without additional infringement on the free exercise of religion. 3. advocating the taboo: incorporating philosophical exemptions most advocates of childhood vaccination and mandatory immuniza­ tion programs vehemently oppose the allowance of philosophical or person­ al belief exemptions.246 my suggested modifications of indiana's religious exemption provisions would likely curtail the would-be ex emptor's ability to secure a religious exemption based on philosophical grounds alone. yet the constitutional demarcation between religious and philosophical beliefs is decidedly unclear,247 opening up to litigation any denial of a religious exemption due to its philosophical (as opposed to religious) foundation. more worrisome is the possibility that allowing religious exemptions and denying philosophical exemptions is of itself unconstitutional. while not permitting any non-medical exemption appears constitutionally sound, 248 if 245. see rota et al., supra note 75, at 647. 246. see, e.g., mobeen h. rathore, op.-ed., vaccines key to health, sun sentinel (fort lauderdale), nov. 23, 2008, at 4f ("all concerned citizens should write their state legislators and the governor and ask them to prevent any efforts to place our children at risk by weakening childhood vaccination programs .... "). see also offit, supra note 37, at alo ("(a]s anti-vaccine activists continue to push more states to allow for easy philosophical exemptions, more and more children will suffer and occasionally die ftom vaccine­ preventable diseases."). 247. see supra note 178 and accompanying text. 248. see brown v. stone, 378 so2d 218 (miss. 1979), cert. denied, 449 u.s. 887 (1980). 2010] mandatory immunization programs 153 not inherently reasonable,249 permitting religious exemptions while denying those based on personal beliefs may run afoul of the establishment clause and the fourteenth amendment. 250 hoosier politicians may be reluctant to present the image of abandon­ ing genuine public health interests by instituting a de jure philosophical be­ lief exemption. but such an action would not necessarily undermine indiana's mandatory vaccination programs. first, de facto personal belief exemptions are already possible in indiana.251 establishing a de jure ex­ emptionwith requirements for averment of sincerity and detailed explana­ tion of the basis of personal objections may actually decrease the use of personal belief exemptions from the status quo. second, the inclusion of an "informed refusal" provision can ensure that parents at least receive information regarding the relative risks and the socio-economic impacts involved in the decision not to vaccinate, 252 thus reducing the likelihood of a dangerous and unnecessary proliferation of ex­ emptions. arizona, for example, allows an unvaccinated student to attend school if her parent "submits a signed statement to the school administrator stating that [he or she] has received information about immunizations pro­ vided by the department of health services and understands the risks and benefits of immunizations and the potential risks of nonimmuniza­ tion ... .'.z53 indiana could incorporate an informed refusal provision rang­ ing from the simple requiring parents to review and sign a vaccination information brochure in the presence of a health care professional to the complex requiring attendance at a public seminar held by the local health department that presents similar information and holds a question and an­ swer session. these educational efforts may help change the minds of indi­ viduals who would otherwise secure exemptions, thus helping to prevent the tragedy of the public health common. third, allowing for personal belief exemptions may in fact engender trust for government authorities in the general public through a formal rec­ ognition of the importance of individual autonomy. combined with the educational aspects of informed refusals, this step may reduce the belief held by some constituents that government authorities are in collusion with vaccine manufacturers. continuing to prevent those genuinely opposed to vaccinations from receiving relief through an exemption only serves to "ex249. see offit, supra note 37, at aio ("we don't allow philosophical exemptions to restraining young children in car seats, to smoking in restaurants or to stopping at stop signs."). 250. see supra notes 154-60 and accompanying text for discussion regarding the poten­ tial for political entanglement with religion to violate the establishment clause and the poss­ ible equal protection violations from disparate treatment of the religious and secular. 251. see discussion supra part iv.a4.b. 252. for a succinct and clear introduction to the concept of informed refusal in the im­ munization context, see silverman, supra note 6, at 294. 253. ariz. rev. stat. ann. § 15-873 (west supp. 2008). 154 indiana health law review [vol. 7:117 acerbate feelings of animosity and skepticism toward vaccination and the public health system in general." 254 the general assembly can establish such a personal belief exemption by converting the religious exemption statutory provisions to general sin­ cerely-held belief exemptions without reference to the source of those be­ liefs. 255 such an amendment would allow state authorities to successfully navigate "the channel between the scylla and charybdis ... in order to sur­ vive constitutional scrutiny.'.256 the resulting exemption provisions would likely be immune to challenges under the establishment and free exercise clauses while simultaneously increasing the palatability of the state's man­ datory immunization program by allowing for limited relief where the pro­ gram may significantly infringe upon individual autonomy. making the process of obtaining the exemptions arduous, but not prohibitive, will avoid the demonstrated deleterious effects of affording personal belief exemptions on immunization coverage. 4. revisions of mandatory immunization reporting requirements part of the difficulty of tracking the impacts of exemptions from im­ munization requirements arises from the way in which data regarding ex­ emptions are gathered and maintained. data aggregation at the state level masks geographic differences in vaccination coverage within communi­ ties.257 when the data do not distinguish between reasons for medical ex­ emptions, or even between medical and non-medical exemptions, their value for epidemiological analysis is compromised. in order to monitor exemption impacts on vpd trends, state agencies must begin tracking ex­ emptions with more detail. reports of medical exemptions should include the health care provider from whom the exemption originates, so that statistical aberrations such as an unusually high number of exemptions from one provider or facility can alert local or state authorities to the possibility of abuse. medical ex­ emption reports should also include the nature of the underlying cause, if only to the level of permanent (e.g., allergies) or temporary (e.g., injuries or infections) contraindications. this information would allow public health authorities to assess the efficacy of annual reviews at the local level and would enable officials to enforce immunization requirements for exemp­ tions that expire by law.258 finally, the data should be collected and pre­ served for analysis at the county level, allowing public health authorities to recognize dangerous pockets of unvaccinated populations within the state. 254. silverman, supra note 6, at 293. 255. see, e.g., cal. healm & safety code§ 120365 (west 2006). 256. thomas, 450 u.s. at 721 (rebnquist, j., dissenting). 257. see supra text accompanying notes 183-85. 258. see ind. code ann. § 21-40-5-4 (west 2008). 2010] mandatory immunization programs 155 in addition, agencies should, pursuant to authority granted in· the amended exemption statutes, establish rules requiring periodic renewal of all exemptions. periodic renewal would serve two complementary purpos­ es. first, it would ensure that temporary medical exemptions expire as con­ templated by statute,259 thus promoting the vaccination of students' for whom immunizations are no longer contraindicated. second, the benefits of increased complexity in the exemption application process would be multiplied with each iteration of expiration. 5. attempting to internalize the negative externalities of immunization ex­ emption independent of an individual's sincere aversion to vaccinations or con­ flicting religious beliefs, the current structure of indiana's mandatory im­ munization program provides incentives for parents to avoid immunization through exemption. because of indiana's high level of vaccination cover­ age,260 a family within a community can enjoy the benefits of herd immuni­ ty without having to actively participate in immunization programs. by opting for exemption over vaccination, the individual avoids the potential adverse effects of vaccinations as well as the costs and burdens of receiving the vaccinations. the exemptor internalizes these benefits while externaliz­ ing to the community at large the detriments of decreased herd immunity and increased possibility of transmission. indiana should consider enacting provisions that at least partially remove these discrepancies between . ex~ emptors and participants in order to decrease the number of exemptions sought. one method would be to estimate the total financial cost of complying with the mandatory vaccination schedule and to place this price upon ex­ emption applicants as a processing fee. to avoid the implication of dispa­ rate treatment, the reviewing agency could refund this nominal processing fee if it denies the application. this system would reduce or remove the financial incentive to choose exemption over compliance with the vaccina.., tion schedule. it could also simultaneously reduce the possibility of the availability of exemptions violating the establishment clause of the first amendment or the equal protection clause of the fourteenth amend­ ment.261 the revenue, albeit likely of minor scope, could be used to fund the educational initiatives of an informed refusal requirement or to defray the costs of administrative review of exemption applications and periodic records audits at schools and child care facilities. an equally effective alternative would be to fully subsidize the cost of 259. jd. 260. see ryker, supra note 227. 261. see discussion supra notes 154-60 and accompanying text. 156 indiana health law review [vol. 7:117 all vaccinations administered to children in indiana. 262 while the requisite tax increase would likely engender public opposition, and therefore legisla­ tive reluctance, the proposal could be accompanied by a promotion cam­ paign detailing the underlying rationale and cost considerations. because every hoosier benefits from a high level of vaccination coverage, every hoosier should share in the costs necessary to attain that coverage and its resulting herd immunity. such a publicly-funded system would redistribute the financial burden of immunizations to all individuals while simulta­ neously reducing the risk of large-scale expenditures that could result from outbreaks among unvaccinated individuals. 263 it would also effectively re­ move the financial incentive component of decisions to seek exemption from vaccination requirements, thus altering the rationale justifying deci­ sions that would promote the tragedy of the public health common. v. conclusion in the past, vpds wreaked havoc throughout the united states. through state-implemented mandatory immunization programs, morbidity and mortality resulting from infectious diseases plummeted and some vpds have been completely or nearly eradicated. because of the continuing threat of reintroduction, however, states must remain vigilant to prevent vpd outbreaks and enable eradication. while mandatory childhood immu­ nization remains the most efficacious method for combating vpds, parents fearing the adverse effects of vaccinations increasingly resist mandatory immunizations. the simple modifications to indiana's mandatory immuni­ zation program proposed in this note would allow the state to continue promoting public health while simultaneously addressing parental misgiv­ ings and recognizing the fundamental importance of individual autonomy. by establishing a program that aggressively enforces immunization man­ dates, but also allows for well-considered exemptions, indiana can become a national leader in preventing the tragedy of the public health common. 262. currently vaccines are only available free of charge to the children of parents una­ ble to afford vaccinations. ind. code ann. § 20-34-4-4 (west 2008). 263. see supra text accompanying notes 55-58. , eleaaor dearman kinney eleanor d. kinney, founding director of the school's internationally recognized williams. and christine s. hall center for law and health, is one of the nation's leading experts on health law. after graduating from law school, she practiced law for four years, then worked as an estate planning officer for duke university medical center for two years. after earning her master's degree in public health, she served as program analyst for the u.s. department ofhealth and human services in washington, d.c. immediately prior to joining the faculty in 1984, she was assistant general counsel of the american hospital association. a widely published author and respected lecturer on the subjects of america's health care system, medical malpractice, health coverage for the poor, and issues in administrative law, professor kinney is author or co-author of numerous law review articles, book chapters and book reviews. she published protecting american health care consumers (duke university press 2002) and edited the guide to medicare coverage decision-making and appeals(aba publishing 2002). professor kinney has served as a consultant to the administrative conference of the united states, president clinton's task force for health care refonn, and the indiana commission on health care for the working poor. she has been appointed by the governor of indiana to the executive board of the indiana state department ofhealth and to other task forces and advisory boards. she served as chair of the patient safety subcommittee of the indiana commission on excellence in health care. during 1999-2000, professor kinney taught and conducted research as a fulbright fellow at the national university of la plata in la plata, argentina. she is the executive director of the latin american law program, and also serves as an adjunct professor at the iu school ·of public and environmental affairs and at the iu school of medicine. recent activities: professor kinney served as chair of the american bar association's section on administrative law and regulatory practice in august, 2005. she is a member of the american law institute. in february 2006, the indiana health law review held a symposium on ''pay for performance" in conjunction with the mcdonald merrill ketcham award and lectureship. this symposium addresses a health care provider payment strategy that, ideally, would alter the way in which public and private health plans pay for health care services. it would reward health care providers that obtain discernible results in the care of patients. if structured correctly, it has the potential to change fundamentally, and hopefully for the better, the way in which health care services are delivered in the united states. professor bill sage of columbia university school oflaw, the recipient of our highest award, gave the keynote address on "pay for performance: will it work in theory?" an article on this topic leads this symposium. professor sage is well deserving of the mcdonald merrill ketcham award for his considerable contributions to the fields of law and medicine. in brief, professor sage has engaged in a career ofhighly innovative and imaginative legal and policy analysis on issues, such as medical malpractice, of great concern to both professions. he has also moved beyond scholarly analysis to promote his ideas and reforms through vigorous advocacy of new ideas and approaches with policy-makers and opinion leaders. he has pursued his work with courage, integrity, and grace. professor sage joined the columbia faculty in 1995 where he teaches health law, regulatory theory, antitrust, and professional responsibility. he has also worked as an intern at mercy hospital and medical center in san diego and as a resident in anesthesiology and critical care medicine at johns hopkins hospital. in addition, he was an associate at o'melveny & myers in los angeles, and served on the president's task force on health care reform. he has been the principal investigator for the pew charitable trusts' project on medical liability in pennsylvania. his awards and honors include election as fellow of the hastings center, receiving the robert wood johnson foundation investigator award in health policy research, serving on the editorial board of health affairs, serving on the institute ofmedicine's committee on rapid advances in health care, and the jcaho tort resolution and injury prevention roundtable. he has published widely in the area of health care law and is co-editor of uncertain times: kenneth arrow and the changing economics of health care (duke university press, 2003). professor sage received his a.b. from harvard and his m.d. and j.d. degrees from stanford where he was the note editor for the stanford law review. we were also honored to have a fine array of commentators on this important topic at the live symposium in february. these speakers have contributed articles to this symposium as well. the first comment, by william h. thompson; president, hall, render, killian, heath & lyman, p.c., is entitled "aligning hospital and physician incentives in the era of pay-for­ performance" and emphasizes the need for proper alignment of incentives if pay for performance is to be a successful strategy. the next comment is from c. paul w azzan, a principal with lecg, corp. which provides financial and economic analysis in the areas of securities, options and futures, antitrust, damage analysis, health and labor economics, and intellectual property. dr. wazzan's comment is entitled "an economic analysis of the impact of pay-for-performance initiatives on physicians, patients and insurance providers" and continuously explores the economic implications of the pay for performance strategy. dr. wazzan is joined as an author by kali prasun chowdhury, william r. sellman, m.d., and michael a. zimmerman, m.d. mr. chowdhury is a research analyst at lecg, corp. drs. sellman and zimmerman are full time practicing physicians in northern california. mr. chowdhury and dr. sellman attended the symposium and participated as part of the discussion panel. the next comment address some of the more technical issues associated with the implementation of pay for performance as well as its implementation in indiana. david e. kelleher, who spoke at the symposium, and j. marc overhage have contributed a comment entitled: "pay-for-performance in central indiana." mr. kelleher is president ofhealthcare options, inc. and executive director of the employers forum of indiana. dr. overhage is president and ceo of the indiana health information exchange, senior scientist at the regenstrief institute, inc., and professor of medicine in the department ofmedicine at the indiana university school ofmedicine as well as a prolific scholar on medical informatics; at the symposium, two notable speakers provided oral presentations. first, david lee, m.d., vice president ofhealth care management in indiana at anthem blue cross and blue shield, spoke on the implications of pay for performance for indiana providers and payers. then thomas b. valuck, m.d., m.h.s.a., j.d., medical officer and the senior adviser to the director of the center for medicare management at the centers for medicare & medicaid services spoke on what the medicare program was doing regarding pay for performance·. also included in this volume is an article written by richard dolinar, m.d. and luke leininger. this contribution provides a critical viewpoint regarding pay for performance programs and discusses many problems that may arise or are associated with these programs. dr. dolinar and mr. leininger have researched numerous health care policy topics and written extensively on their findings. this contribution provides a different perspective in that it questions whether pay for performance should be a national policy and abdicates agencies should not implement these types of incentive systems. this issue also contains the "report of the council on ethical and judicial affairs: physician pay-for-performance programs" (american medical association). this contribution was written by nathan a. bostick, a senior research assistant with the ama, dr. robert m. sade, a professor of surgery at the medical university of south carolina in charleston, and dr. john, w. mcmahon, sr., corporate medical director and principal clinical coordinator of the mountain-pacific quality health foundation. included in the symposium edition is a comment provided by the center for studying health system change, "can money buy quality: physician response to pay for performance." hsc is a nonpartisan policy research organization. the mission of the center for studying health system change is to inform health care decision makers about changes in the health care system at both the local and national levels and the effects of such changes on people. hsc seeks to provide objective, incisive analyses that lead to sound policy and management decisions, with the ultimate goal of improving the health of the american public. the article provides a unique physician perspective to the pay for performance initiative. another contribution is the white paper from the integrated healthcare association entitled "advancing quality through collaboration; the california pay for performance program." the integrated healthcare association is a nonprofit healthcare leadership group in california composed of health plans, physician groups, hospitals, and healthcare systems, plus purchaser, pharmaceutical, technology, consumer, and academic representa­ tives. by engaging the various sectors ofhealthcare delivery in dialogue and collective action, the iha develops policy and special projects centered on integrated healthcare and managed care. on behalf of the student members and faculty advisors of the indiana health law review, it gives me great pleasure to introduce this second issue, focused on this unique and timely topic. we hope you find the materials enlightening and beneficial. sincerely, eleanor d. kinney hall render professor of law & co-director, william s. and christine s. hall center for law and health indiana university school of law-indianapolis achieving quality and responding to consumers the medicare beneficiary complaint process: who should respond? • diane e. hoffinann, j.d., m.s.*• & virginia rowthom, j.d. ••• table of contents i. introduction •.•.•.•.•••••••.••••...•.•••..••.••••••••..•••....•••....••••..•.••••.....•.•..•...... 10 ii. the qio complaint process····················································~········ 13 a. history ......................................................................................... 13 b. complaint process generally ..................................................... 16 c. co'flidentiality ............................................................................. 17 d. co"ectiveaction ........................................................................ 19 e. sharing with other.agencies ...................................................... 21 f. number of complaints handled by q/os ................................... 22 ill. concerns .about the current qio system .................................. 23 iv. alternative to qios for responding to beneficiary complaints ..................................................................................... 26 a. state survey agencies .................................................................. 28 * an earlier version of this paper was prepared at the request of the center for medi­ care advocacy and presented on january 19, 2007, at a daylong working conference entitled beyond q/0: modeling a medicare beneficiary complaint process for quality of care. forty­ two health policy experts attended the meeting, including beneficiary advocates, professors of law and public policy, attorneys, physicians, policy researchers, industry representatives, gov­ ernment officials, congressional staff members, and representatives of various agencies that handle medicare beneficiary complaints, to develop an alternative structure for responding to beneficiary complaints about quality of care. this paper formed the basis for the development of a "consensus model of an ideal medicare beneficiary complaint review system." additional information about the project, which was supported by a grant ftom the commonwealth fund, can be found at http:/lwww.medicareadvocacy.orglprojects_ qioconference.htm. we would like to express our special thanks to peter hollman, m.d., who also presented at the 2007 confer­ ence, for his invaluable comments and contributions to this paper. we would also like to thank alfted j. chiplin, jr., j.d., m.div., managing attorney, and toby s. edelman, ed.m., j.d., senior policy attorney, at the center for medicare advocacy for reading our paper and provid­ ing comments and insights, many of which we incorporated into our paper. finally, we would like to thank our student research assistants, rebecca jesada and vanessa schultz for their tire­ less assistance. ** diane e. hoffinann, professor of law. director. law & health care program, uni­ versity of maryland school oflaw. *** virginia rowthorn. managing director, law & health care program, university of maryland school of law. 10 indiana health law review [vol 5:9 1. history of responsiveness of state survey agencies to consumer complaints .................................... : .................... 28 2. characteristics of the current complaint process ............... 31 b. state medical boards .................................................................. 37 c. combined entity including state survey agency and state medical board ........................................................................... 42 1. elements of an alternative complaint entity ........................ 43 2. assessment of alternative complaint entity .......................... 45 v. conclusion .......................................................................................... 49 mary anderson was distraught about the care her 83 year old mother was receiving at shady village nursing home. when she went there to visit her yesterday mary discovered that her mother had a large decubitis ulcer on her back. she complained to the nursing home administrator but did not think that was enough. she knew that decubitis ulcers can be prevented by good quality care. mary did not want to sue, but she wanted to find out how this happened, who was at fault, and to make sure it did not happen again. she wondered to whom she should address her concerns the nursing home om­ budsman? the state agency that licenses long term care facilities? or some other entity? i. introduction quality improvement ("qi") has become a mantm in virtually all service industries, but perhaps more so in health care. in part, qi can be informed by consumer and patient complaints. ideally there is a feedback loop linking com­ plaint information to those responsible for quality improvement. yet respon­ siveness to complainants and quality improvement efforts can sometimes be at odds or at least create tensions. such tensions arise between, among other things, the joint goals of: confidentiality of provider information and tmnspar­ ency in explaining what happened to patients; provider autonomy and quality improvements that require across the board adherence to standards with little flexibility; due process in investigating complaints and providing patients with timely responses to their inquiries; and between a private mediated resolution and public sanctions to deter similar behavior by others. these tensions are playing out in a debate between medicare beneficiary advocates, the centers for medicare and medicaid services ("cms"), and the quality improvement or­ ganizations ("qios") that are currently responsible for responding to benefici­ ary complaints about poor quality health care. that debate is the motivation for this paper, which examines what type of entity is most appropriate to respond to complaints by medicare beneficiaries regarding the quality of care they receive. 2008] the medicare beneficiary complaint process 11 in its relatively short history, the medicare beneficiary complaint process that currently rests within the nation's qios has been the subject of three major reportstwo by the department of health and human services' ("dhhs") office of the inspector general ("oig'') and one by the institute of medicine ("10m"). the first of those reports focused on how the process could be im­ proved while remaining within the qio program.1 the second report recom­ mended that cms either make major improvements to the current process within the qios or establish a complaint process outside of the qio program? the final and most recent report made a single recommendation regarding the complaint process"[t]he qio in each state should no longer have responsibil­ ity for handling beneficiary complaints, appeals, and other case reviews for payment or other purposes.'.j as support for taking the complaint process out of the qio program has increased, various suggestions have been made regard­ ing a new ''home" for this important function. the second report, prepared by the oig, suggested establishing a new program or contract mechanism within cms or, alternatively, building on "existing entities that already conduct simi­ lar work, such as state survey and certification agencies, state medical licen­ sure boards, and the state health insurance partnership program.'.4 the most recent report, prepared by the 10m, recommended that cms consolidate the beneficiary complaint and review functions "into a few regional or national competitive contracts" or, alternatively, "determine the most appropriate agen­ cies with which to contract for [this] purpose in each state.'.s among those agencies, the report suggested "state health departments and the state [s]urvey and [ c ]ertification agencies.'.6 the medicare advocacy community has also made efforts over the last several years to raise awareness of deficiencies in the qio beneficiary com­ plaint process. the coalition for consumer and quality in health care re­ form, the center for health care rights, the national senior citizens law center, the center for medicare advocacy ("cma"), the citizen advocacy center ("cac"), and aarp provided official comments on the 1995 oig re­ port.7 aarp and cac provided official comments on the 2001 oig report.8 most recently, in january 2007, the cma held a day long working conference 1. see dhhs office of inspector gen., pub'n no. oei-01-93-00250, the beneficiary complaint process of the medicare peer review organizations (1995), http://oig.hhs.gov/oei/reports/oei-ol-93-00250.pdf[hereinafter 1995 oig report]. 2. seedhhsofficeofinspectorgen.,pub'nno.oei-01-00-00060, lhemedicare beneficiary complaint process: a rus1y safely valve (200 i), http://oig.hhs.gov/oei/ reports/oei-01-00-00060.pdf[hereinafter 2001 oig report]. 3. inst. of men., medicare's quality improvement organization program: maximizing potential 112 (national academic press 2006) [hereinafter 2006 iom report]. 4. 2001 oig report, supra note 2, at iii. 5. 2006 10m report, supra note 3, at 112. 6. see 2006 10m report, supra note 3, at 115. 7. 1995 oig report, supra note 1, at 36-49. 8. 2001 oig report, supra note 2, at 32-45. 12 indiana health law review [vol. 5:9 for which an earlier version of this paper was commissioned, on alternative structures for the medicare beneficiary complaint process.9 the most recent push for reform of the qio beneficiary complaint process has come from congress. on august 2, 2007, united states senators charles grassley and max baucus introduced senate bi111947, the "continuing the advancement of quality improvement act of2007 ." the bill requires a major overhaul of the qio program and would strip the beneficiary complaint func­ tion from the qios and place it with new "medicare provider review organi­ zations.''10 this bipartisan bill, which has received support from the medicare advocacy community,11 awaits action by the senate finance committee. more recently, two bills were introduced in both houses that would, among other things, make changes to the qio program's beneficiary complaint process but leave the review process with the qios. senate bill2396 was filed on novem­ ber 16, 2007, by senators orrin hatch, john rockefeller, trent lott, and ed­ ward kennedy. section 2 of the bill requires that beneficiaries be informed of the results of complaints they file about quality of care matters and what actions were taken as a result of the complaint. the bill was referred to the senate fi­ nance committee. the same language is included in house ofrepresentatives billl046, filed on february 14,2007, by congressman michael burgess, a member of the house energy and commerce committee, subcommittee on health, the committee to which the bill was referred upon introduction. no further action has been taken on any of these legislative proposals. while there is considerable merit to removing the complaint process from the qios entirely and creating a new entity to handle such complaints, this solu­ tion could result in a duplication of effort between the new entity and existing state and federal entities in the area of complaint investigation. this article is designed to add to the debate about the most appropriate home for the benefici­ ary complaint process by evaluating an alternative to the qio complaint struc· ture based on existing entities that already conduct similar work. first, the article examines the current qio process, including its history and structure, as well as some of the specific areas that have been the subject of particular scru­ tiny over the years, i.e., confidentiality of provider information, corrective ac­ tion, sharing with other agencies, and the number of complaints handled annually by qios. the article then sets forth the criticisms of the qio pro­ gram as identified in several studies, criteria for evaluating alternatives to qios, and an alternative to qios for responding to beneficiary complaints that incor­ porates state survey agencies and state medical boards. this alternative takes advantage of already existing expertise in the area of complaint resolution; 9. see asterisk, supra prior to note 1. 10. continuing the advancement of quality improvement act of2007, s. 1947, lloth cong. (2007). 11. see center for medicare advocacy praises the "continuing the advancement of quality improvement act of2007," med. news today, aug. 16,2007, http://www.medical newstoday.com/articles/79723.pbp (last visited jul. 13, 2007). 2008] the medicare beneficiary complaint process 13 however, the alternative is not put forth as a recommendation but rather as a springboard for examining the next steps that might be taken to improve the medicare beneficiary complaint process. 12 ii. the qio complaint process a. history the qio program (formerly referred to as the medicare utilization and quality control peer review organization or "pro" program) was created by statute in 1982.13 the qio program is ''the federal government's primary tool for assuring that services provided to medicare beneficiaries are medically nec­ essary, of a quality that meets professionally recognized standards of health care, and provided in an appropriate setting."14 the government spends ap­ proximately $400 million a year on the program's forty-one contractors, which covers all fifty states and washington d.c., puerto rico, and the virgin is­ lands.15 in addition to other quality improvement activities, qios have been required since 1986 to review and investigate all written complaints received from medicare beneficiaries about the quality of medicare-covered services received in medicare-certified facilities. 16 the work of the qios is governed by three-year contracts drafted to con­ form to a "statement of work" ("sow'') that is produced by cms.17 the qios will operate under the eighth sow until july 31, 2008.18 during the first three sow contracts, the focus of the qio program was to ensure the necessity, quality, and appropriateness of care rendered to medicare beneficiaries by iden­ tifying individual clinical problems through random medical record review. since 1993, when the fourth sow contracts took effect, qios have aimed to improve the overall practice of medicine by analyzing patterns of care and out12. our research for this paper included a review of the available literature and govern­ ment documents, interviews with two directors and one former director of state survey agen­ cies, a representative from the federation of state medical boards, as well as conversations with a director of a state medical board, a qio consultant, and staff at cms. in addition, we re­ ceived comments from the american health care quality association on an earlier draft of the paper. 13. the peer review improvement act ofl982, pub. l. no. 97-248, sec. 143, §§ 11511163, 96 stat. 324 (1982), abolished the old professional standards review organizations and created the peer review organization program. which was intended to be a leaner and more effective program than its predecessor. in 2002, pros were renamed qios. see 61 fed. reg. 35,539 (may 24, 2002). 14. barry r. furrow et al., heal1h law§ 3-24 (2d ed. 2000). 15. 2006 10m report, supra note 3, at 63, 180-81. 16. omnibus budget reconciliation act of 1986, 42 u.s.c. § 1320c-3(a) (2000). 17. see furrow et al., supra note 14, § 3-24. 18. the eighth sow began on august 1, 2005 and runs through july 31, 2008. see 8th round sow contract 148 (2005), http://www.cms.hhs.gov/qualitylmprovementorgs/ downloads/8thsow.pdf. 14 indiana healm law review [vol. 5:9 comes and by sharing information with the medical community. this more re­ cent emphasis on patient care and outcomes was initiated in response to rec­ ommendations made in a 1990 10m report which assessed medicare quality assurance efforts.19 under this newer approach, mndom sample record reviews were phased out and cms, at the initiation of the fourth sow, emphasized the importance of the beneficiary complaint process in carrying out the work of the qio program. in a 1994 statement describing its vision of a successful pro five years down the road, cms suggested that these organizations ''will have earned a position of trust in the eyes of plans, providers, and practitioners and beneficiar­ ies" and that this public trust will be ''based on responsive investigation of complaints and protection of consumers . ..2o this view was echoed in a 1995 report issued by the oig entitled the beneficiary complaint process of the medicare peer review organizations ("1995 oig report").21 in that report, the authors noted that, as medical record review declines, ''the [qio] process for receiving and investigating complaints from medicare beneficiaries takes on added significance. it becomes a major vehicle through which the [qios] can identify and respond to individual instances of poor medical care. it is vital, therefore, that the complaint process be functioning well. ,,zz the manner in which qios handle complaints has evolved with each suc­ cessive sow and the significance of this function has increased in response to a number of critical reports.23 a 2001 oig report entitled the medicare bene­ ficiary complaint process: a rusty safety valve ("200 1 oig report'')24 found that, at least through the sixth sow (1999-2002), beneficiary complaints were treated as a "distinctly minor activity" by cms and therefore by the q10s.25 in that sixth sow, the complaint process fell under ''other contract activities." this catch-all section represented eighteen percent of the estimated qio budg­ et.26 in response to the 2001 oig report, the role of the beneficiary complaint process was reevaluated and, in the seventh and eighth sow contracts, benefi­ ciary complaint resolution was included in "medicare beneficiary protection activities." an estimated $45.5 million dollars (or 5.8% of the core contract) was allocated to these "protection activities" in the seventh sow.27 in addi19. see medicare: a stratboyfor quauly assurance, vol 2 (kathleen n. lobr ed., the nat'l acad. press 1990). 20. 1995 oig report, supra note 1, at 2 & f-2 n.7. 21. see 1995 oig report, supra note 1. 22. id. ati. 23. see discussion infra. see also 1995 oig report, supra note i; 2001 oig report, supra note 2; 2006 iom report, supra note 3. 24. see 2001 oig report, supra note 2. 25. id. at 14. 26. id. 27. see200610mrbport,supranote3,at 181 tbl.7.7. theiomreportnotedthatthese "[c]alculations are approximate and were done by the 10m committee on the basis ofcms da­ ta." id. the 10m report also noted that the total estimated budget for the seventh sow was 2008] the medicare beneficiary complaint process 15 tion to upgrading the importance of the complaint process in the sow, cms modified the process to ''be more service-oriented and responsive to beneficiar­ ies'.28 by adopting a case numager approach, revising "response determination categories .. and subsequent actions to be taken upon a determination offering a satisfaction survey to beneficiaries, and offering mediation as an alternative to the medical record review process. 29 following a six-state pilot project conducted in 1998-99,30 the use of me­ diation as an alternative to case review for resolution of beneficiary complaints was implemented throughout the entire qio system in september 2003/1 but the option has met with mixed results. the 2006 10m study, entitled medi­ care's quality improvement organization program: maximizing potential ("2006 iom report''), found that, as of july 2004, only fifteen states had com­ pleted at least one mediation under this new option. 32 according to a cms of­ ficial, while mediation is currently offered by every qio, it has not taken off as a remedy because it is only available in a small subset of complaints33 and not all qios are making the same effort to promote mediation.34 although cms and the qios believe ili,at mediation has improved beneficiary satisfaction, they also have found it to be labor intensive. 35 therefore, cms has sought addi$1,154.3 million, of which $796.7 million supported core contract activities and $357.6 million covered support contracts and special studies. ld. at 180 tbl. 7 .5. the report further noted that, "[a]s of may 31, 2005, the total apportionment for the 8th sow was slated at $1,265 billion, a nine percent increase overthatforthe 7th sow." id. at 179. 28. cms. for medicare& medlcaidserv., mediation: anew0pnonformedicare beneficiaries to resolve complaints filed through qio 1(2004), http://www.cms.hbs.gov ibenecomplaintrespprog/downloads/3a.pdf [hereinafter cms, mediation). 29. ld. 30. see press release, lumetra, mediation becomes option to resolve medicare benefi­ ciary complaints (dec. i 0, 2003), available at http://www.lumetra.com/about-lumetra/index. aspx?rpid1=46&id=129. seealso200610mreport,supranote3,at308;20010igreport, supra note 2, at 2 & 49 n.5 (citing the california medical review incorporated [now lumetra], in collaboration with the university of california at san francisco, rand corporation, and center for social redesign, the medicare beneficiary complaint alternative methods study, 500-96-p535, modification p00014 (oct. 1999)). 31. see david g. schulke, am. healm quauty ass'n, medicare beneficiary complaint processqiqs and possible alternatives: comments and suggestions 2 (2007), http://www.medicareadvocacy.orgiqioconference/substantivelnfo/ahqaresponseto llegalbgpaper.pdf [hereinafter qio comments]. 32. see2006 iomreport,supranote3,at319. "[i]njuly2004, cms releasedanrfp for competitive special study pxx401 entitled 'beneficiary protection program activities al­ ternatives to traditional case review in beneficiary complaints' via sdps memorandum 04304-co." qio comments, supra note 31, at 2. 33. cms divides quality complaints into cases where "no substantial improvement op­ portunities are identified" or "care could have been better." where "care could have been better," the cases fall into one of three groups: "1) care was grossly and flagrantly unaccept­ able; 2) care failed to follow accepted guidelines or usual practice; 3) care could reasona­ bly have been expected to be better." cms considers cases falling into groups i or 2 "not suitable" for mediation. cms, mediation, supra note 28, at 2. 34. telephone interview with commander sheila c. blackstock, director, division of quality improvement program policy for acute care quality improvement group, ocsq, cms, in baltimore, md. (nov. 22, 2006). 35. qio comments, supra note 31, at 2. 16 indiana heal til law review [vol. 5:9 tiona! alternatives to case review. cms funded a study by new york's qio to test "alternative approach improvement methodology," a qio-facilitated method of alternative dispute resolution. methods developed under this study were incorporated into the eighth sow.36 b. complaint process generally the scope of review ofbeneficiary complaints is set forth in the qio ma­ nual published online by cms. in order for a qio to handle a complaint, the complaint must: 1) pertain to a. service covered by medicare regardless of whether the service was covered for the particular beneficiary making the com­ plaint or whether medicare payment was made on behalf of that beneficiary; 2) relate to a service furnished by a health care practitioner, or an institution or non-institutional provider who, at the time of the service, was qualified to have payment made to them; 3) relate to a service furnished while the complainant was a medicare beneficiary; and 4) be in writing.37 the qio manual outlines the basic roadmap for a qio responding to a complaint. qios are to: 36. !d. at 3. • acknowledge receipt of the complaint • request medical records • receive medical records • complete quality review o determine whether the quality of ser­ vices met professionally recognized standards of health care. o if no potential quality concern is identi­ fied during retrospective review, com­ plete review and send a written determination to the involved provid­ ers/practitioners. o if a potential quality concern is identi­ fied, provide notice to the pro­ vider/practitioner to discuss and/or provide a response to the potential con­ cern. complete review and send a writ­ ten determination to the provider/ practitioner involved. 37. see ctrs. for medicare& medicaid servs., quality improvement oro. manual ch. 5, § 5005 (2003), http://www.cms.hhs.gov/manuals/downloads/qiol10c05.pdf[hereinafter cms, qio manual]. if a beneficiary attempts to make an oral complaint. the qio manual states that assistance should be provided to help the beneficiary make the complaint in writing. !d.§ 5010. 2008] the medicare beneficiary complaint process o if a potential quality concern is con­ firmed, give the provider/practitioner notice of the qio's final determination, including their right to request a re­ review of the determination. • provide an opportunity for the pro­ vider/practitioner to consent to or prohibit the disclosure of information that explicitly or im­ plicitly identifies that practitioner. • respond to complainant • take corrective action o require quality improvement plans (such as safety measure initia­ tives/preventive measures). o recommend oig sanction.38 c. confidentiality 17 the issue of confidentiality has been the achilles heel of the complaint process since the first critical oig report in 1995. specifically, qios have been criticized for responding inadequately to complainants by allowing practitioners to prohibit disclosure of information that explicitly or implicitly identifies them. the result of this prohibition was that qio response letters to complainants were extremely vague-not even indicating if substandard care had been found. the 2001 oig report asserted that qios have a difficult time obtaining physi­ cian consent, particularly when the medical record review substantiates a qual­ ity of care concern. according to that report, qios obtain consent in just twenty-one percent of complaint reviews where such a concern is identified (and forty-two percent where no such concern is identified). 39 the disclosure prohibition within the complaint process is grounded in the peer review improvement act40 ("peer review act'') and the implementing cms regulations. under the statute, any data or information acquired by the qio must not be disclosed except: 1) to the extent necessary to carry out the goals of the legislation; 2) by regulations that must be designed to assure pro­ tection of the rights of patients and practitioners; and 3) to certain federal or state agencies.41 based on this statutory framework, cms promulgated regula­ tions defining "confidential information" as, among other things, "information that explicitly or implicitly identifies an individual patient, practitioner or re38. /d. §§ 5005-5040. 39. see 2001 oig report, supra note 2, at 11. 40. peer review improvement act of 1982, pub. l. no. 97-248, §§ 141-150, 96 stat. 381 (codified as amended at42 u.s.c. §§ 1320c-1320cl2). 41. 42 u.s.c. § 1320c-9(a) (2000). 18 indiana healm law review [vol. 5:9 viewer.'.42 the administrative history of the regulations indicates that the agen­ cy believed general disclosure of confidential information would be inappropriate, because ''the potential is great [that] such information [would] be misinterpreted and misused.'.43 cms further felt that general disclosure of identifying information could "reduce the effectiveness of the peer review process. ,,44 the confidentiality issue is muddied somewhat by another provision of the peer review act, requiring qios to inform beneficiaries of the final dispo­ sition of a complaint.45 balancing these two mandates was the subject of a fed­ eral district court case in 2001, in which the nonprofit organization public citizen sued cms alleging that the regulations which prohibited disclosure by a qio of the final disposition of a complaint investigation were at odds with the peer review act.46 in that case, the petitioner, on behalf of a widower who complained to a qio about the treatment his late wife received, argued that the confidentiality requirements were incompatible with the statutory requirement that the qio "inform the individual (or representative) of the organization's final disposition of the complaint.'.47 the court of appeals for the district of columbia affirmed the lower court's decision that the term "final disposition" requires a qio to inform complainants of the substantive (rather than procedur­ al) disposition of the complaint. in a somewhat ambiguous holding, the court held that "the statutory command to inform a complainant of the 'final disposi­ tion' of the complaint requires more than what [cms] currently permits. at a minimum, it requires the organization to notify the complainant of the results of its review.'.48 the court further stated that a qio must "disclose its determina­ tion as to whether the quality of the services that the recipient received met 'professionally recognized standards ofhealth care. ,,49 the court would not go as far as to require a qio to reveal to a complainant what corrective action it took in response to the complaint but stated that doing so "represents a reason­ able elaboration of the meaning of the term [fmal disposition].'.so as a result of this case, letters to complainants now reveal more information than before, but the essential problem of disclosure of practitioner-identifying information re­ mains. qios are still prohibited from disclosing such infonnation without con42. 42 c.p.r.§ 480.101(b) (2006). 43. 50 fed. reg. 15,347-01, 15,355 (apr. 17, l985)(setting forth the final rule for 42 c.p.r. pts. 400 and 476). 44. id. 45. the omnibus budget reconciliation act of 1986, pub. l. no. 99-509, sec. 9352, 100 stat. 1874,2047 (codified as amended at 42 u.s. c.§ 1320c-3(a)(14) (2000)) added this section. 46. public citizen, inc. v. dep't of health & human servs., 332 f.3d 654 (d.c. cir. 2003), aff'd, 151 f. supp. 2d 64 (d.d.c. 2001). 47. ld. at 657 (citing 42 u.s.c. § 1320c-3(a)(14) (2000)). 48. /d. at 656. 49. /d. at 671 (quoting 42 u.s.c. § 1320c-3(a)(l4) (2000)). 50. /d. 2008] the medicare beneficiary complaint process 19 sent51 and are therefore limited in the information they can provide to com­ plainants. cms has attempted unsuccessfully to address this issue of confidentiality. in response to the 1995 oig report, cms worked on revising the confidential­ ity regulations, but reported that it was unable to publish a final rule. 52 in his response to the 2006 iom report, secretary of the department of health and human services, michael leavitt, again addressed the issue and stated that "in addition to the current beneficiary complaint work, cms is determining how it can permit the disclosure of information from complaint review to beneficiaries and restrict redisclosure of this information and its use in liability actions."53 in the view of the authors of the 2006 iom report, the "qio confidential­ ity restrictions are not necessary or supportable in the current era of public re­ porting and are incompatible with the aim of a national performance measurement system and the goal of cms to serve multiple audiences with a transparent system. "54 the report further notes that "[b ]ecause the qio legisla­ tion gives the secretary ofdhhs the authority to set confidentiality standards by regulation, new legislation for this purpose is not necessary" and may there­ fore be modified by the secretary to increase the transparency and responsive­ ness of the qios. 55 d. corrective action it is clear from the qio manual that corrective actions on the part of a qio following a substantiated complaint investigation, while permitted, are not considered an integral part of the complaint process. the 2001 oig report found that qios "rarely take any action beyond a notification letter to providers 51. see cms, qio manual, supra note 37, § 5020, § 5025, & exh.s-17 (final response to inquirer model notice (concern involved practitioner)). the model final response letter in a case in which the involved practitioner does not consent to disclosure states: we have carefully examined your concern(s) and conducted a thorough re­ view of the medical records pertaining to the services that (you or name of beneficiary) received. federal regulations prohibit us from releasing infor­ mation that identifies the involved practitioner without his or her consent. because the involved practitioner did not give (his or her) consent, we are unable to release information that would explicitly or implicitly identify him/her. this does not necessarily mean that we found a problem with the services (you or name ofbeneficiary) received. however, we will take ap­ propriate action if warranted by our review findings. jd. exh.5-17. 52. see 2001 oig report, supra note 2, at i. 53. michael 0. leavitt, sec'y of health & human services, rep. to cong.: lmprovlng the medicare quality lmprovement0rganiza110n programresponse to the institute of medicine study 22~23 (2006), http://www.cms.hhs.gov/qualitylmprovementorgsldown loads/qio _improvement_ rtc _fnl.pdf. 54. see 2006 iom report, supra note 3, at 125. 55. jd. 20 indiana health law review [vol. 5:9 and practitioners in response to confirmed quality concerns based on com­ plaints.'.s6 the same report found "no examples of a [qio] calling for remedial training, coursework. or special supervision.'.s7 the report also found that "more serious interventions, such as referring a physician to the state medical board ... were even rarer.'.ss only nine of the fifty qios that responded to the survey undertaken in that study "reported making such a referral at least once during their fifth [sow]" (a period of three years). 59 likewise, the study found that qio referrals to state survey agencies are uncommon, finding that only "six [qio]s reported making such referrals for confirmed concerns during their fifth [sow].'.6° the qio manual offers the following non-directive advice regarding cor­ rective actions a qio may undertake: you may engage in a variety of activities, including the development of corrective action plans, to improve care rendered by providers/involved practitioners when qual­ ity concerns are id~tified. . • . you may consider coor­ dinating efforts with other entities such as intermediaries, carriers, state agencies, cms regional offices, ... oig, or state licensing/certification boards to effectuate corrective action . . . . you may also con­ sider initiating improvement projects, when appropri­ ate/feasible. 61 under statute, a qio may initiate sanction proceedings by referring case infor­ mation and sanction recommendations to the oig. 62 the qio manual instructs qios to initiate sanction procedures when they "identify failure by a practitio­ ner in a substantial number of cases to comply with his/her obligations and/or a gross and flagrant violation as specified in section 1156(b) ofthe act and 42 cfr 1004.1(b) ... .'.63 in a critical2005 news article, gilbert m. gaul of the washington post reported that, "from 1986to 1994, qios recommended 278 sanctions against all providers, mostly doctors. from 1995 to 2003, they rec­ ommended 12 sanctions, according to the inspector general's office. in four of the nine years, there were none at all.'.64 gaul concluded that this downward 56. see 2001 oig report, supra note 2, at 9. 57. /d. 58. i d. at 10. 59. id. 60. id. 61. see cms, qio manual, supra note 37, § 5040. 62. 42 u.s.c. § 1320c-5(b)-(c) (2000); 42 c.f.r. § 1004.70 (2006). 63. see cms, qio manual, supra note 37, § 5040. 64. gilbert m. gaul, once health regulators, now partners: private groups limit pa­ tient access to medical files, rarely punish doctors, w asidngton posr, july 26, 2005, at ai. 2008] the medicare beneficiary complaint process 21 trend is related to the current qio emphasis on collaborating with providers. 65 the authors of the 2006 10m report believe that this drop in sanction recom­ mendations is not likely to change given that, under the current sow, qio evaluations (by cms) will be tied to hospital satisfaction ratings to a greater degree than under previous s0ws.66 e. sharing with other agencies one might argue that qios need not sanction health care providers for poor quality care as that is already done by state survey and certification agen­ cies and state medical boards. yet, these state agencies and boards must know about provider infractions or complaints before they can respond to them. con­ sequently, one might expect the agencies to share information, but this does not happen on a routine basis. no formal relationship, for example, exists between state medical boards and qios. in nonbinding language, the qio manual suggests that qios "[p ]articipate in the overall beneficiaty complaint network with other entities',(j7 and "[a]dvise these groups of[the qio's] role and responsibility in investigat­ ing beneficiary complaints, and solicit information regarding their role andre­ sponsibility .• .68 according to a 2006 dhhs study entitled state discipline of physicians ("2006 dhhs board study"), most state medical boards do not seek informa­ tion from qios and "only a few boards in 2003 had formal information sharing agreements with qios.',(j9 currently, qios are not required to report individual practitioners to the appropriate state medical boards for purposes of investigation or discipline. the only entity to which the qios are required to report individual physicians is the oig but, as mentioned earlier, only in the case of repeated or gross viola­ tions of duty. 70 according to qio regulations, "[a] qio must disclose confi65. i d. however, according to the american health care quality association (ahcqa), the decrease in the number of providers referred to the 010 for sanctions is related to the sig­ nificant decline in retrospective record review activity undertaken by qios since the fifth sow (under which random record reviews were phased out). see qio comments, supra note 31, at 5-6. 66. see 2006 iom report, supra note 3, at 113. 67. see cms, qio manual, supra note 37, § 5045. 68. id. 69. randall r. bovbjerg et al., dhhs, state discipline of physicians: assessing state medical boards through case studies 34 (2006), http://aspe.hhs.gov/daltcp/reports/ 2006/stdiscp.pdf [hereinafter 2006 dhhs board study] (citing federation of state medical boards, exchange: licensing boards, structure and disciplinary functions tbl.29 (2003)). only twelve boards reported having formal agreements with qios and twelve more reported receiving assistance from qios on an occasional basis. ld. at 80 n.47. 70. in comments made on the initial draft of this paper, ahcqa stated that under cms guidance immediate reporting to a licensing authority "should occur" in the case of grossly or flagrantly unacceptable care or immediate harm to a patient see qio comments, supra note 31, at 6-7 (emphasis added). however, the guidance to which ahcqa refers is arguably op22 indiana heal til law review [vol. 5:9 dential information upon request, to state or f ederallicensing bodies responsi­ ble for the professional licensure of a practitioner .... "71 the regulation fur­ ther states that "a qio may provide the [confidential] information ... to the state or federal licensing body without request."72 in egregious cases, addi­ tional cms guidance provides that qios must report complaints to the appro­ priate licensing board.73 we were unable to find information as to how often qios report offending physicians to state medical boards, however, when ex­ trapolating from the number of physicians that qios report to the oig/4 the incidence is presumably quite low. the qio manual also states that qios may "consider coordinating efforts with other entities such as intermediaries, carriers, state agencies, cms re­ gional offices, office of the inspector general, or state licensing/certification boards to effectuate corrective action ... . "15 any such efforts must conform to disclosure requirements, which are consistent with the qios' overall confiden­ tiality policy: only fraudulent actions or actions involving imminent danger to individuals can be reported to state agencies without first notifying the provider of the disclosure to the state. 76 based on interviews with state survey agency directors, many state agencies are unaware that qios respond to beneficiary complaints. one state survey agency director with whom we spoke commented that there are potential dangers to having parallel state complaint processes that do not communicate with each other, the most important being the possibility of a dangerous situation existing without the state survey agency being aware of it. f. number of complaints handled by q!os qios are required to report beneficiary complaint information in their an­ nual reports, which must be posted on individual qio websites. we researched the websites of all fifty-three qios in december 2006. at that time, forty-five out of fifty-three qios had their annual reports available online, although many did not have the most recent report online. judging from the number of com­ plaints reported by qios on their websites, the greatest number of complaints received by a qio in a single fiscal year was 306 in california in fiscal year 2005.77 this is the equivalent of 0. 71 complaints per 10,000 part a medicare beneficiaries in california. at the time of our review, eight of the qios retional. 71. 42 c.f.r. § 480.138(a)(l)(i) (2006) (emphasis added). 72. !d. at (a)(l)(ii) (emphasis added). 73. see qio comments, supra note 31, at 6-7. 74. see supra note 64. 75. see cms, qio manual, supra note 37, § 5040. 76. see 42 c.f .r. § 480.1 05(b )(2) (2006). 77. see lumetra. california annual medical services review report: time frame 11/1/2004-10/3112005, http://www.lumetra.com/uploadedfileslresource-center/docslannual-me dical-services-review-2005.pdf. 2008] the medicare beneficiary complaint process 23 ported fewer than ten complaints in a single year in their most recently posted annual reports. 78 the 2006 10m study reported that the number of complaints reviewed by qios nationwide is surprisingly smallapproximately 3,000 during fiscal year 2004, or about one for every 14,000 beneficiaries.79 following the fifth sow, cms published a document that compiled the number and nature of complaints filed with qios during that sow. in the three-year contract period, qios re­ ceived 7,218 quality complaints, 1,407 (19 .5%) of which had at least one con­ firmed concern. 80 information about the numbers and types of complaints received by qios is difficult to attain. cms requires qios to post annual re­ ports online and provides them with a template to do so. however, in our opin­ ion, the template does not set forth information in a user-friendly way and therefore makes complaint information difficult to decipher. ill. concerns about the current qio system as previously stated, the qio complaint process has been the source of several critical reports since 1995.81 in march of2006, the institute of medi­ cine issued a report that recommended taking the beneficiary complaint process out of the qios.82 this report reviewed the qio program as a whole and in­ cluded recommendations regarding the beneficiary complaint process. there­ port was requested under section 1 09( d)(l) of the medicare prescription drug, improvement, and modernization act of 2003 to help the senate finance committee understand how the qio program fits within the evolving perform­ ance improvement efforts in the nation's health care system.83 in addition to these critical reports, the process was the subject of the lawsuit discussed above.84 although cms made changes in response to each negative report, the criticisms have been fairly consistent over time. such criticisms may therefore indicate that the identified problems with the complaint process are intractable systemic issues that cannot be resolved without a significant programmatic overhaul. the most consistently reported criticisms of the qio complaint 78. the eight qios were in delaware, hawaii, montana, nebraska, south dakota, ver­ mont, virgin islands, and wyoming. 79. see 2006 10m report, supra note 3, at 113. 80. cms office of clinical standards & quality, data review project, peer review or­ ganizations (pros), 5th scope of work: national findings (4/1996-2/2000), http://provide rs.ipro.org/shared/admin _ memos/medicare/200202.pdf 81. see notes 1-3 supra and accompanying text; 1995 oig report, supra note 1; 2001 oig report, supra note 2; 2006 10m report, supra note 3. 82. see 2006 10m report, supra note 3, at 112-14. 83. ld. at l. 84. public citizen, inc., 332 f .3d 654 (d.c. cir. 2003) (qff' dpublic citizen, inc., 151 f. supp. 2d 64 (d.d.c. 2001)). 24 indiana ileal til law review [vol. 5:9 process can be divided into categories of accessibility, responsiveness, effec­ tiveness, and accountability. in terms of accessibility, or the ease with which the complaint process can be accessed by beneficiaries, the qios do not score well. both the oig and the iom found that medicare beneficiaries lack awareness of the qio complaint review function and that the process is difficult to access. 85 although there is no current information regarding the number ofbeneficiaries who know about the qio complaint process, the 1995 010 report found that seventy-seven per­ cent of medicare beneficiaries were not aware of the q10s.86 the 2006 10m report noted that in general, many beneficiaries may be unaware of their local qio and more specifically, its complaint review functions, "even though the contact information for all qios is listed in the medicare handbook.',s7 addi­ tionally, the iom report noted that even if the medicare beneficiary finds the qio internet home page, only some qio websites ·~rominently feature infor­ mation on how consumers can submit complaints.' 8 for example, when we reviewed the homepage of california's qio, lumetra, it recommended that beneficiaries call the national medicare hotline rather than contact the qio directly.89 secretary leavitt admitted that accessibility was a problem in his 2006 response to the 10m study in which he stated: ''to support needed changes in the qios very important complaint review activities, cms will en­ gage qios to expand outreach to beneficiaries through media, print publica­ tions, direct communications, and work with the cms ombudsman on developing a link on the cms web page. "90 qios have also been consistently criticized for their lack of responsive­ ness to complainants, specifically that they do not respond in a meaningful way.91 in response to the court's ruling in the public citizen case, qios now provide complainants with their determination as to whether the quality of the services met professionally recognized standards ofhealth care. however, they still do not reveal information that identifies a practitioner. this fact, coupled with the fact that the qios refer so few practitioners to state medical boards, 85. see 1995 oig report, supra note 1, at 5-6; 2001 oig report, supra note 2, at 7-8; 2006 10m report, supra note 3, at 113-14. 86. see 1995 oig report, supra note 1, at 5. 87. see 2006 10m report, supra note 3, at 113. 88. /d. 89. see lumetra, for medicare members, bttp:/lwww.lumetra.com/resource­ center/index.aspx?id=l30 (last visited jul. 13, 2007). qios are required to post this toll-free phone number on all beneficiary-targeted materials, including websites. see qio comments, supra note 31, at 9. however, qios are not required to direct all complaints to that number. in contrast to lumetra's website, at the time of our review, the website of the delmarva foundation (the qio for maryland and the district of columbia) bad a link on its homepage informing be­ neficiaries how to make complaints about quality of care directly to the delmarva foundation. see delmarva foundation, consumer medicare resoun:es, http://www.delmarvafoundation.org /consumers/medicare/complaints.html (last visited jul. 13, 2007). 90. leavitt, supra note 53, at 23. 91. see 1995 oigreport,supranote 1,at6;2001 oigreport,supranote2,at 11-12. 2008] the medicare beneficiary complaint process 25 means that the process essentially has no corrective consequences for practitio­ ners. qios have also been criticized for failing to use complaint data in a man­ ner that helps· identify patterns of poor care, despite the fact that the primary responsibility ofqios is to encourage quality improvement in medicare." the 2001 oig report found that ''just [one 1 of 50 [qios 1 reported implementing a quality improvement project based on beneficiary complaints."92 in this same vein, qios have been criticized for treating "complaints as individual incidents, rather than as potential signs of systemic problems."93 in terms of investigative capacity, the oig found that qios do not use full congressionally-authorized investigative authority and rarely go beyond record review when investigating a complaint. 94 any adequate complaint system must have the ability to apply remedies or sanctions upon substantiating a complaint. qios have been criticized for rarely taking action beyond a letter to the provider or practitioner who was found to have provided substandard care.95 further, as mentioned above, qios rarely make referrals to licensing boards96 and the number of sanctions against physi­ cians recommended by qios has dropped dramatically since 1986.97 according to the 2006 10m report "qio surveys of complaints revealed high levels of beneficiary satisfaction with the complaint review process but much lower levels of satisfaction with the outcomes of the reviews. "98 cms reports that "93% of complainants are now satisfied with the review process. "99 this satisfaction with the process makes sense given that, after the 1995 oig report, cms changed its guidelines for how long the complaint process should take, reducing ''the total days allowed from 250 to 165 days and developing model letters to improve the readability of[qio] responses to complainants."100 from the beneficiary's point of view, however, the outcome of the reviews is still unsatisfactory, according to the iom report.101 this may well have to do with the intractable confidentiality problem. as secretary leavitt noted in his recent report to congress, "[m]ost complainants want a process that helps them understand what happened, and if there is something that should not have oc­ curred, they want to know that action has been taken to prevent future occur­ rences."102 92. 2001 oig report, supra note 2, at 11. 93. /d. at8. 94. /d. at 8-9. 95. /d. at9. 96. 2001 oig report, supra note 2, at 10. 97. see 2006 10m report, supra note 3, at 113. 98. /d. at 114. 99. leavitt, supra note 53, at 22. 100. 2001 oig report, supra note 2, at 2. 101. see 2006 10m report, supra note 3, at 114. 102. leavitt, supra note 53, at 22. 26 indiana health law review [vol. 5:9 finally, qios were criticized in the 2001 oig report because the qio complaint process is not subject to public accountability.103 aggregate data regarding qio complaint investigations is not available on the cms website. such data can only be compiled through the often outdated and difficult to de­ cipher information on individual qio web pages; a number of reports have identified obstacles to qio effectiveness in the area ofbeneficiary complaints. in addition to the confidentiality constraint, the oig and 10m have enumerated various "conflict of interest" issues that dis­ courage qios from treating beneficiary complaints as a high priority activity. these include the fact that: 1) "cms' contracts with [qios] treat complaints as a distinctly minor activity;"104 2) "[qios] tend to be more oriented [toward] the medical community than to the beneficiary community;"105 3) qios do not con­ sider beneficiaries primary clients;106 4) "technical assistance activities are in­ compatible with a strong regulatory function;"107 5) the qio mission is to attract providers to enroll in quality improvement programs;108 and 6) evalua­ tion of qios by cms is based, in part, on hospital satisfaction ratings.109 in its 2006 report, the iom recommended that cms ease conflict of interest restric­ tions with regard to qio subcontracts. the report suggested that, given limits on federal funding, "qios should be allowed to seek funds for quality im­ provement activities from providers and other organizations as appropriate."110 while this recommendation may help qios achieve their mandated objectives overall, loosening conflict of interest restrictions is bound to make it even more difficult for qios to juggle their various roles vis-a-vis health care providers and beneficiaries. n. alternative to qios for responding to beneficiary complaints in this section, we evaluate an alternative entity to qios for responding to medicare beneficiary complaints. the alternative takes advantage of existing structures that currently respond to patient complaints about quality of care: state survey agencies and state medical boards. below we describe how these entities respond to patient complaints and, in the final section, we discuss and 103. see 2001 oig report, supra note 2, at 13-14. 104. !d. at 14. 105. id. at 15. 106. see 2006 iom report, supra note 3, at 112. 107. !d. at 113. "(w]orking collaboratively with providers and investigating their activi­ ties within a single contract can create an inherent conflict of interest for the qios." !d. at 114. 108. !d. at 113. 109. !d. qios will be under more pressure to improve relations with providers in the eighth sow because the weight ofhospital satisfaction ratings will increase to twenty-five per­ cent ofqio evaluation. id. 110. id. at 139. 2008] the medicare beneficiary complalnt process 27 evaluate a combined alternative structure which builds upon the extensive ex­ perience these entities have in dealing with complaints about patient care. in their reports, both the 10m and oig stated that in addition to looking at existing organizations, cms might consider establishing a new program or con­ tract mechanism within cms to respond to beneficiary complaints. 111 as we approached the issue of where the beneficiary complaint process should be lodged, we considered the possibility of cms or qios contracting with a new entity that would be devoted solely to handling and resolving medicare benefi­ ciary complaints. 112 presumably, this entity would be funded by money cur­ rently directed to qios for this process and would be subject to specific uniform criteria as to the handling of complaints. the benefit of creating a separate contract for this function would be the opportunity to establish an en­ tity that would be specifically focused on responding to beneficiary complaints. at a minimum, this could reduce concerns about qio conflicts of interest. 113 we did not address the feasibility or benefits of such a new entity or how it might be constructed. rather, on initial reflection, we concluded that such an entity would likely face some of the same problems that now trouble qios. these problems include lack of visibility, lack of available sanctions, and, pos­ sibly, the same confidentiality issues. in addition, if the contracts were given to newly created entities it would duplicate the efforts of existing organizations that currently receive and investigate complaints in each state and have consid­ erable experience doing so. although there is merit to both solutions, we chose to assess the feasibility of relying on existing mechanisms with better coordination as, arguably, an im­ portant next step before moving forward to establishing a new entity. while existing mechanisms for complaint review have pros and cons, an understand­ ing ofhow they function provides a possible alternative solution to a new entity or, in the case a new entity is created, can inform the characteristics of the new entity. lll. see 2006 iom report, supra note 3, at 112; 2001 oig report, supra note 2, at iii. 112. this is the model proposed ins. 1947, see supra note 10. 113. having qios subcontract for specific tasks has been considered by cms. during the drafting of the eighth sow, cms discussed the possibility of allowing or requiring qios to subcontract out those tasks for which the qios were unable to demonstrate competency ( compe­ tency demonstrated through successful evaluation of performance under a previous sow or other ems-approved means). this idea was not well received by the qio community, which argued that such a rule would be inconsistent with existing law and would favor non-qios be­ cause they would be ''free to seek the work of qios without meeting the tests congress estab­ lished for qios" to qualify for funding. see letter from david g. shulke, executive vice president of the american health quality association, to secretary mack mcclellan, adminis­ trator, cms 5 (sept. 20, 2004), http://www.ahqa.org/pub/uploads/ahqacommentssow8 draftsummary.pdf (regarding the proposed eighth sow). 28 indiana iiealm law review [vol. 5:9 a. state survey agencies state survey agencies have been mentioned by the iom and oig as poten­ tial alternatives to qios in responding to consumer complaints about quality of care in health care facilities. 114 all fifty states and the district of columbia have an office that is responsible for surveying and licensing health care institu­ tions within that state. these agencies, which often have toll-free numbers and websites with information about how to make a complaint, routinely receive complaints and conduct complaint investigations. the survey function is carried out under agreements between the state and the secretary ofdhhs in order to ensure that all providers participating in the medicare and medicaid programs meet minimum health and safety standards or "conditions of participation." these providers may include: ambulatory sur­ gery centers, community mental health centers, end stage renal disease facility providers, home health providers, hospices, hospitals, intermediate care facili­ ties for the mentally retarded, clinical laboratories, nursing homes, psychiatric residential facility providers, rehabilitation providers, and rural health clinics. these facilities are also licensed by states, which may have additional quality standards that the facilities must meet for licensing purposes. the survey and complaint response functions are supported, in part, by cms, which provides funding to the states to carry out these tasks.115 the association of health facility survey agencies (ahfsa), a national association of state survey agencies, provides a forum for directors of these of­ fices to share infonnation and address common interests. ahfsa has one paid staff person and a board of directors comprised of directors of state survey agencies. the mission of the organization is to "strengthen the role of its mem­ ber state agencies in advocating, establishing, overseeing, and coordinating health care quality standards that will assure the highest practicable quality of health care for all state and federally regulated health care providers."116 1. history of responsiveness of state survey agencies to consumer com­ plaints there is little information or data available about the responsiveness of state survey and licensing agencies to consumer complaints. to the extent data exists, it has focused primarily on complaints regarding nursing home care. in 114. see supra notes 2-3. 115. while every state is required by federal law to conduct surveys of nursing homes for purposes ofmedicare certification. states vary in terms of the extent to which they conduct sur­ veys of other institutional health care providers. most states, for example, "have to a greater or lesser degree incorporated jcaho accreditation into their hospital licensure standards." furrow et al., supra note 14, at 8. as a result, states may not routinely survey hospitals and rely on jcaho to carry out this function. 116. ass'n of health facility survey agencies, ahfsa mission, http://www.ahfsa.org/ about%20ahfsa.htm (last visited jul. 16, 2007). 2008] the medicare beneficiary complaint process 29 1995, the health care financing administration (hcfa) (now cms), was concerned about problems with state survey agency responses to nursing home complaints and "developed complaint investigation protocols for states" to fol­ low.117 however, the general accounting office (gao) determined in a 1999 report that such protocols were not sufficient 118 in that report, the gao docu­ mented that states did not always investigate complaints of harm to nursing home residents promptly or at all, 119 despite the fact that all state agencies must conduct certification surveys of nursing homes and "maintain procedures and adequate staff to investigate and report on the nursing home complaints they receive. "120 in response to the gao report, then-hcf a administrator, nancy-ann deparle, met with the board of directors of ahfsa to discuss the problems with complaint investigations and stress the urgency of improving all enforce­ ment efforts. in addition, hcf a also: • directed all [ s ]tate survey agencies to investi­ gate any complaint alleging harm to a resident within 10 working days; • reiterated to [ s ]tates that complaints alleging immediate jeopardy to residents must be inves­ tigated within two days; • stressed to [ s ]tates that they must enter com­ plaint information into [the hcfa] data sys­ tem [oscar] promptly; • published a regulation ... allowing [s]tates to impose fines for each instance of a violation; and • [beganhavinghcfa] [r]egional [o]fficestaff conduct surveys to verify nursing home resi­ dent complaints when necessary.121 moreover, hcf a initiated a complaint improvement project "to identify key elements of the complaint process, address resident and consumer concerns 117. nursing home complaint investigation: hearing before the s. select comm. on ag­ ing, 1 06th cong. (1999), available atwww.cms.bhs.gov/appslmedialpreslease.asp?counter =571 (statement of mike hash, deputy adm'r health care financing admin.) [hereinafter hash, hearing teytimony]. 118. see u.s. gen. accounting omcb, pub. no. gao/hehs-99-80, complaint investigation processes offen inadequate to protect residents 16-17 (1999), http://www.gao.gov/new.itemslhe99080.pdf. 119. id. 120. dhhs, office of inspector general, pub. no. oei-01-04-00340, nursino home complaint investigations 1 (2006), http://oig.bhs.gov/oeilreports/oei-01..()4..00340.pdf[bere-­ inafter 2006 010 nursing home complaint report) (citing social security act, 42 u.s.c. §§ 1395i3(g)(4)(a)-(g)(5)(a) (2003)). 121. hash, hearing teytimony, supra note 117. 30 indiana health law review [vol. 5:9 about the process, and develop standards for prioritizing complaints and deter­ mining appropriate time frames for investigations."122 in testimony at a hearing before the senate special committee on aging, then deputy administrator of hcf a, mike hash, stated that hcf a had determined that the key elements of the complaint process included: • informing consumers of their right to make complaints and how to do so; • the complaint intake process, including how complaints are received, classified and sched­ uled for investigation; • the investigation process, including the train­ ing, knowledge, attitudes, and case load of in­ vestigators; • the resolution process, for determining wheth­ er a complaint is substantiated; • the administrative hearing process, including back-log of cases; • the compliance or response process for ad­ dressing substantiated complaints, including the range and actual use of remedies and back­ log of actions; and, • interactions between complaint investigations and licensure and certification systems, the le­ gal system, and facility-level grievance or con­ tinuous quality improvement processes.123 based on information received from the complaint improvement project, hash stated that hcf a would "develop [ f]ederal minimum standards and produce a manual for states describing each element of a model complaint investigation process, how [ s ]tates should implement the process, and necessary training and staffing levels."124 furthermore, hash stated that hcfa would "specifically evaluate how well [ s ]tates respond to consumer complaints and how promptly and thoroughly they report investigation results to [hcf a] to determine wheth­ er they meet their survey responsibilities. ,m in october 2000, cms established the state performance standard re­ views which set performance standards for state survey agencies. these annual reviews "serve as cms 's primary oversight mechanism" for state agency per­ formance in responding to complaints. 126 the 2002 performance standards, for 122. !d. 123. /d. 124. /d. 125. /d. 126. see 2006 oig nursing home complaint report, supra note 120, at 3. 2008] the medicare beneficiary complaint process 31 example, required that "[s ]tate agenc[ies) triaged and initiated investigation of 100 percent of the complaints [they] received alleging or involving actual hann (high) to individuals consistent with cms and [s]tate policy."127 a gao report released in 2005 indicated that cms oversight of state survey activities had improved 128 however, the report recommen~ that cms "[t]inalize the development of guidance to states for their complaint investiga­ tion processes and ensure that [the guidance] addressd key weaknesses, includ­ ing the prioritization of complaints for investigation .... "129 2. characteristics of the cu"ent complaint process over the last few years, cms did two things to improve its oversight of state agency response to complaints. in 2004, cms implemented the aspen complaints incident tracking system (acts) to standardize reported com­ plaints, allowing analysis across state survey agencies and the ability to evaluate state complaint investigations.130 in march 2006,131 cms formalized its state guidance for complaint investigation processes, incorporating its recommenda­ tions (management of complaints and incidents) into the state operations ma­ nual ("som").132 the procedures are to be. followed when complaints and reported incidents involve medicare or medicaid certified providers or suppliers. the som acknowledges that complaints133 or related information can come from beneficiaries, their families, health care providers, citizens, public 127. id. at 15. 128. see u.s. gov't accountability omce, pub. no. ga0-06-117, nursing homes: despite increased oversight, challenges remain in ensuring high quality care and resident safety (2005), http://www.gao.gov/new.items/d06117.pdf[hereinafter 2005 gao report]. in november 2002, cms also initiated the nursing home quality improvement ini­ tiative in an effort to, among other things, increase oversight over quality initiatives of state survey agencies and qios and to foster and improve communication between these agencies, as well as independent health quality organizations, advocates and nursing home providers. hash, hearing testimony, supra note 117. 129. 2005 gao report, supra note 128, at 52. 130. see 2006 oig nursing home complaint report, supra note 120, at i. the acts "includes more comprehensive complaint information than the previous repository for nation­ wide complaint data, the online survey certification and reporting system (''oscar'')." id. 131. cms, transmittal18 (2006), http://www.cms.hhs.govltransmittals/downloads/ r18soma.pdf. 132. cms, state operations manual (2006), chapter 5, http://www.cms.hhs.gov /manualsldown1oadslsoml 07c05.pdf[hereinafter som]. "as part of the agreements with cms under which state survey agencies operate, som requirements are contractually binding on medicare-certified and medicare-medicaid dually certified nursing homes." 2006 oig nursing home complaint report, supra note 120, at 1. 133. the som defines a complaint as an "allegation of noncompliance with federal and/or state requirements" (som, supra note 132, § 5010), and states that "complaints that are not directly related to federal requirements" may be forwarded to the "appropriate agency(ies) for follow-up and investigation.'' such complaints may include allegations of''medicare/medicaid fraud, complaints against individual licensed practitioners, and billing issues." id. § 5000.1. complaints alleging non condition-level noncompliance may be referred to the relevant accred32 indiana hea.lrn law review [vol. 5:9 agencies, or media reports and that after a complaint is received subsequent communication with the complainant may be necessary in order to evaluate and prioritize the complaint. the som provides a list of intake information that state survey agencies should collect in the initial or follow up contact with the complainant. this information includes: • the complainant's name, address, telephone, etc.; • the individuals involved and affected; • the narrative and specifics of the complainant's concerns including the date, and time of the al­ legation; • the complainant's views about the frequency and pervasiveness of the allegation; • the name of the provider/supplier including lo­ cation (e.g., unit, room, floor) of the allegation, if applicable; • how/why the complainant believes the alleged event occurred; • whether the complainant initiated other courses of action, such as reporting to other agencies, discussing issues with the provider, and obtain­ ing a response/resolution; and • the complainant's expectation/desire for resolu­ tion/remedy, if appropriate.134 as part of the intake process, the survey agency ("sa") is to provide the com­ plainant with the following: • the policies and procedures for handling in­ takes including the scope of the sa's regula­ tory authority and any considerations pertaining to confidentiality; • the course of action that the sa or ro 135 will take and the anticipated time frames; • information about other appropriate agencies that could provide assistance including the iting organization.jd. § 5010.2. 134. id. § 5010.1. 135. ro refers to the cms regional office. the som provides 1hat the sa must forward certain allegations to the cms.regional office. cms ros are "responssble for monitorfug the sas' management of complaints and incidents to assure that the sas are complying with the provisions set forth in [t]ederal regulations, the som, and cms policy memoranda." id. § 5050. 2008] the medicare beneficiary complaint process name and telephone number of a contact per­ son, if available; and • an sa contact name and number for follow-up by the complainant. 136 33 sas are expected to input all complaint data from initial intake and inves­ tigation through final disposition into acts. "[d]ata entered into acts is subject to [t]ederallaws governing disclosure and the protection of an individ­ ual's right to privacy."137 the som includes maximum time frames for sas to initiate investiga­ tions in response to complaints of immediate jeopardy and complaints regarding a high or medium probability of harm at nursing homes, non-deemed providers other than nursing homes, and deemed providers. 138 the som further provides guidance to sas in responding to complain­ ants. such responses generally should include: • acknowledgement of the complainant's con­ cerns; • a statement of the sa's regulatory authority to investigate the complaint and any statutory or regulatory limits that may bear on its authority to conduct an investigation; • a summary of the sa's investigation methods (e.g, on-site visit, written correspondence, tel­ ephone inquiries, etc.); • date( s) of investigation; • an explanation of the sa's decision-making process including defmitions of terms used; • a summary of the sa's finding; 139 • a description of follow-up action, if any, to be taken by the sa (e.g., follow-up visit, plan of correction review, no further action, etc.); and • appropriate referral information (i.e., other agencies that may be involved). 140 136. id. § 5010.2. the qio manual requires that similar information be provided in the initial follow-up letters to complainants. see cms, qio manual, supra note 37, § 5010. 137. som, supra note 132, § 5060. 138. id. § 5070. an organization is considered "deemed" when a national accrediting commission, such as the joint commission, provides cms with verification that the organiza­ tion meets or exceeds appropriate federal requirements. a "deemed" organization therefore is deemed to meet medicare (or medicaid) certification requirements. 139. "the swnmary should not compromise the anonymity of individuals, or include spe­ cific situations that may be used to identify individuals, when anonymity has been requested or is appropriate in the judgment of the sa." id. § 5080.1. 34 fiidmnah~thlawrevmw [vol. 5:9 although this guidance is relatively new, a july 2006 oig report provides some information about the compliance of state sas with the state performance standards and the som provisions in responding to complaints about nursing homes. significant findings from the oig included the following: • "state agencies did not investigate some of the most serious nursing home complaints within som-required timeframes." in 2004, based on the state performance standard reviews, sas did not investigate seven percent of com­ plaints alleging "immediate jeopardy'' in the required forty-eight hours.141 in addition, sas did not investigate twenty-seven percent of complaints alleging actual harm within there­ quired ten day timeframe.142 • state agencies have not taken full advantage of the acts. sas' ''use of their own data sys­ tems in addition to the acts, technical prob­ lems with the acts, and lack of training have hindered its use as a complaint management tool."t43 • "most state agencies' written policies and pro­ cedures generally incorporate the som; how140. /d. the som recognizes that many states have separate procedures specifying how sas should respond to and manage complaints. according to cms, "[w]henever possible, [s ]tate and [ f]ederal requirements should be integrated to avoid unnecessary duplication." !d. § 5050. 141. 2006 oig nursing home complaint report, supra note 120, at 8. 142. /d. at 9. state perfonnance standards for 2004 included the following: /d. at3-4. • "for ninety percent of randomly selected complaints, the cms regional office must agree with the state agency's prioritization of the complaint;" • ''the [s]tate agency must investigate all immediate jeopardy complaints onsite within two working days;" • "the [ s ]tate agency must investigate all complaints alleging ac­ tual harm (high) onsite in an average often working days, with all investigations completed within twenty working days;" • "the [s ]tate agency must follow cms instructions for handling complaints for no less than eighty percent of nursing home com­ plaints. these instructions include contacting complainants with investigation results and having qualified surveyors complete the nursing home survey, among others." 143. /d. at ii. 2008] the medicare beneficiary complaint process ever, those policies do not incorporate all of the som's guidelines!'144 • "[m]any follow-up letters to complainants lacked meaningful information. "145 although sas appeared to do a good job sending out some kind of response to complainants, there­ sponses "often lacked comprehensive informa­ tion about the complaints such as acknowledging the complainant's concern and summarizing the investigation methods." • "cms oversight of nursing home complaint investigations is limited."146 35 with respect to each of these measures, state performance varies signifi­ cantly from state to state. 147 a significant majority of states, for example, scored well on timeliness in responding to complaints of immediate jeopardy, responding to at least ninety percent of such complaints within the two-day window. yet, ten states failed to respond in the required timeframe between ten and thirty-three percent of the time, and one state failed to respond in a timely manner in over ninety percent of cases alleging immediate jeopardy.148 the inability of states to respond within the required time frames may be attrib­ uted to insufficient agency staffing-both in terms of number of staff and staff competence to evaluate complaints. moreover, a consistent concern across state agencies is a lack of adequate resources to respond to complaints in a timely manner. regarding sa responses to complaints, the 010 found that "[w]hile most of the [s]tate agencies' policies direct their staff to send follow-up letters to complainants, many of the policies provide little or no detail about the required content of [the] letters. "149 of the forty-two policies reviewed by the 010, "on­ ly [nine] require[ d] that follow-up letters to complainants include all of the components cited in the som!'150 the 010 reviewed 498 nursing home complaints that resulted in an onsite investigation. the review indicated that state agencies "generally collected ap­ propriate information during intake, employed qualified professionals to assign priorities to the complaints, and provided the complainant ... with a written report of the investigation findings."151 agencies tended to fall short when in144. jd. 145. !d. 146. !d. 147. seeid.at28tbl.4. 148. see id. 149. !d. at 13. 150. jd. 151. !d. 36 indiana health law review [vol. 5:9 corporating each of the elements listed by the som for inclusion in the re­ sponse to complainants.152 in a letter to the oig regarding its findings, then-cms administrator mark mcclellan pointed out that the number of completed nursing home com­ plaint investigations undertaken by state agencies rose by thirty-seven percent from 1999 to 2005 (from 32,422 to 44,677). the increase, according to mcclellan, "represents both stronger performance and stronger commitment to be as responsive as possible to nursing home residents and their families."153 while state agencies vary considerably with regard to their responsiveness to complaints, there are indications that many states are doing a competent job and have systems in place to effectively track complaints and responses. al­ though many states continue to struggle with inadequate staffing, a number of states have significantly improved their complaint responses over the last two to three years due to federal requirements. although there is no uniform national data available on how often state survey agencies implement various types of corrective actions or sanctions un­ der state laws, these agencies have a range of interventions available to them with which to respond to findings that a facility is providing poor quality care. in addition to issuing letters of deficiency and requiring corrective action, agen­ cies may levy civil monetary penalties or revoke a facility's license. while sas rarely do the latter, they routinely require corrective action plans and follow up with providers to ensure that action is taken. sas also provide due process pro­ tections to providers when levying fines or revoking a license; such protections include an appeal process for providers who contest these actions. in addition, federal rules require that sas provide an informal dispute resolution process for nursing homes contesting citations for deficiencies.154 while sas generally excel in tracking and responding to beneficiary com­ plaints, a major shortcoming of relying solely on sas to perform the beneficiary review function is that their scope of authority is limited to institutional provid­ ers. in determining whether relying on sas to respond to medicare beneficiary complaints is appropriate, it would be helpful to know the percentage of com­ plaints received by qios that address institutional care. one might also argue that health care institutions have significant control over physician practices and 152. see id. at 14 tbl.3 (summarizing the oig's findings on this performance measure). according to the table, letters were missing acknowledgement of the complainant's concerns forty-seven percent of the time, a summary of the investigation methods fifty percent of the time, a discussion of the sa's decision making process twenty-seven percent of the time, and the summary of the sa's findings nine percent of the time. id. 153. see id. at 29 app. c (letter from mark b. mcclellan, administrator, cms, to daniel r. levinson, inspector general, dhhs (may 17, 2006) (responding to oig draft report nurs­ ing home complaint investigations (oei-01-04-00340)). 154. 42 cfr § 488.331 and chapter?, survey and enforcement process. for non-federal surveys, the state must offer a facility an informal opportunity, at the :fucility's request, to dispute survey findings upon the facility's receipt of the official statement of deficiencies. for federal surveys, cms offers a facility an informal opportunity, at the :fucility's request, to dispute survey findings upon the :fucility's receipt of the official statement of deficiencies. id. 2008] the medicare beneficiary complaint process 37 other health care providers, and therefore, sa.s. by effectuating changes in insti­ tutional practices, might be an effective vehicle for influencing practitioner be­ havior. b. state medical boards the oig also mentioned state medical boards as possible entities to take on the review of medicare beneficiary complaints about quality of care.155 in this section we describe the scope and activity of these boards and their re­ sponse to consumer complaints involving physician practices. legislatures in every state have enacted a medical practice act that de­ fines the proper practice of medicine and the medical board's scope of respon­ sibility to regulate that practice within the state.156 most states have separate boards for each medical specialty. state medical boards license providers, in­ vestigate complaints, discipline those who violate the law, conduct provider evaluations and facilitate rehabilitation of providers when appropriate. the basis for discipline does not vary significantly across the states, with most states including "incompetence; gross negligence; aiding and abetting the unlicensed practice of medicine; conviction of a felony or other crime ... ; unlawful sale of drugs; impairment due to drugs or alcohol; and professional discipline in an­ other state ... "157 state medical boards judge the potential offenses that come before them under one of two different standards. nationally, about two-thirds of state medical boards use a "preponderance standard" and one-third use the higher "clear and convincing evidence" standard.158 state medical boards routinely receive complaints about provider behavior and practice and are a potential vehicle to receive medicare beneficiary com­ plaints regarding substandard care. because physicians (unlike other health care providers) generally work independently and are not directly disciplined by the facilities in which they practice, our focus will be on physician boards.159 155. 2001 010 report, supra note 2, at iii. 156. the tenth amendment of the united states constitution authorizes this legislation. which allows states to establish laws and regulations protecting the health, safety, and general welfare of their citizens. see u.s. const. amend. x. 157. furrow et al., supra note 14, at 82. 158. see2006 dhhs boardsludy, supra note69, at 14-15. under a "preponderance of the evidence" standard, a board may make a disciplinary finding from a mere preponderance of the evidence, that is, that an offense more likely than not occurred. !d. under a "clear and con­ vincing evidence" standard, a board may make a disciplinary finding only if the board finds that· there is little doubt that the offense took place. 159. arguably, complaints involving the large majority of other health professionals could be addressed by working through health care institutions. some would argue that institutions, at least hospitals, also have considerable control over physicians via the granting of practice privi­ leges. certain specialists are very dependent on hospital privileges, and while hospitals may be reluctant to take away privileges from physicians and thereby lose referral volume, recent com­ mentaries have encouraged hospitals to adopt a more central role in controlling physician prac­ tices. see lucian l. leape & john a. fromson, problem doctors: is there a system-level solution? 144 annals internal med. 107 • 107 (2006). 38 indiana heal til law review [vol. 5:9 the structure and authority of state medical boards vary from state to state. some boards are independent and maintain all licensing and disciplinary powers; whereas others are part of a larger umbrella agency, such as a state de­ partment of health. state medical boards are typically made up of volunteer physicians and members of the public who, in most cases, are appointed by the governor and paid a nominal stipend for their service. the criticism that boards are "captured" by the profession has received a great deal of attention in the past decade and now, almost every state requires that its board include some number of lay members, on the theory that they are more likely to hold errant physicians accountable.160 the majority of state medical boards typically employ an administrative staff including an executive officer, attorneys, investigators, and licensing per­ sonnel. the state legislature determines the financial resources of most boards. some boards are funded directly from physician licensing and registration fees. board spending per thousand physicians ranges widely and is primarily af­ fected by licensure fee levels and state budgetary policies. a 2006 dhhs study of state medical boards reported the need for increased budgets to im­ prove their complaint processes.161 this report further noted that"[ n ]ationally the best funded 25% of boards receive more than double the resources per in­ state practicing physician as their lower funded counterparts in the bottom 25%."162 while state medical boards play a vital role in the realm of medical com­ plaints, there are significant differences between the fifty-one boards that exist across the country.163 most importantly, not all state medical boards investigate complaints.164 in seven states, this duty is delegated to another agency, most commonly the state's health department.165 another important difference be­ tween boards is their degree of independence from state agencies.166 while most state medical boards are independent, a good number are semi160. see 2006 dhhs board sroov, supra note 69, at 11. 161. see id. at ix. 162. id. at 16. 163. a large part of the information relating to the nation's medical boards in this paper comes from the federation of state medical boards' 2003 exchange, a compendium of informa­ tion about state medical boards published every two to four years. see federation of state medical boards, exchange tbl.29 (2003) [hereinafter fsmb exchange]. the exchange is based on surveys completed by the medical boards that comprise the federation of state medi­ cal boards ("fsmb"). the fsmb is a national not-for-profit organization representing the seventy medical boards of the united states and its territories, including fourteen state boards of osteopathic medicine. for purposes of this paper, we include information relating to the medi­ cal boards in the fifty u.s. states and the district of columbia. it should be noted that three boards (vermont, new jersey, and south dakota) did not respond to the fsmb survey. in addition, new york has two boards-an advisoty board and a professional conduct board. we consider them together for purposes of this report. 164. /d. at tbl.29. 165. see id. at tbls.5 & 8. these states include arkansas, connecticut, florida, hawaii, michigan, nebraska, new york, and utah. 166. see id. at tbl.8. 2008] the medicare beneficiary complaint process 39 independent (generally part of the state's health department) and some are pure­ ly advisory. like the qios, all fifty-one state medical boards have a website available to the public, which vary in terms of their usefulness to patients.167 public citi­ zen168 has analyzed the "user-friendliness" ofthe fifty-one board websites,169 specifically with regard to online physician profiles, and found huge differences between states.170 beyond a website, boards also vary greatly in terms of acces­ sibility. more than half publish a public newsletter, while less than halfhave a toll-free number available to the general public.171 state medical boards also vary as to whether they assure confidentiality to those who report violations.172 on two basic measures, most state medical boards are responsive to com­ plainants: forty-eight of the fifty-one boards acknowledge complaints made to them173 and forty-nine boards inform complainants of the outcome of the com­ plaint.174 unlike the qios, which are currently forbidden by cms from reveal­ ing individual practitioner infonnation without the practitioner's permission, most state medical boards inform complainants of the outcome of an investiga­ tion.m virtually all boards have experience conducting investigations, specifi­ cally in response to health care quality complaints. although state medical boards are generally staffed by practitioners, the 2006 dhhs report found that many boards have difficulty obtaining sufficient medical and legal expertise at both the complaint screening stages and in preparing for and conducting fonnal testimony at hearings.176 speed of complaint resolution varies greatly by state. in the typical state, about ten percent of cases take more than 360 days to resolve.177 according to the 2006 dhhs board study, "[ c ]losure times vary considerably according to 167. seeid.attbl.l6. 168. public citizen is a washington d.c.-based consumer advocacy organization founded in 1971 by ralph nadar. 169. meredithlarsonetal.,pum.icc111zen'sheal1hr.esearchgroup,pub.no.j79j, report of doctor disciplinary information on state web sites: a survey and ranking of state medical and osteopatidc board web sites, at a-12 tbl.7 (2006), http://www.citizen.org/documents/1791med.board2006fullreportweb.pdf. 170. /d. at 18. physician profiles are legislatively mandated in most of the states that did well in the survey and not mandated in states that did poorly in the survey. ld. at 19. in this study, public citizen evaluated the websites based on the following criteria: availability and types of physician-identifying information; state board disciplinary action information; hospital disciplinary action information; federal government disciplinary action information; malpractice and conviction information; and user-friendliness. /d. at 5-6. according to the evaluation, new jersey hosts the most user-friendly website and north dakota hosts the least user-friendly. i d. 171. see fsmb exchange, supra note 163, at tbl.16. 172. id. attbl.18. 173. id. at tbl.35. florida, indiana, and utah are the exceptions. 174. id. indiana and utah are the exceptions. 175. id. 176. see 2006 dhhs board study, supra note 69, at vii. 177. id. 40 indiana healm law review [vol. 5:9 how far through the disciplinary process a case proceeds. nationally, in 2003, cases resolved before or during investigation averaged 180 days from intake to closure, 425 days for cases closed after investigation but before hearing, and 675 days to reach hearing."178 furthermore, all of the states in the study re­ ported a backlog in cases.179 unlike qios, all state medical boards have broad disciplinary decision­ making ability that they routinely employ.180 the following table lists the most common board sanctions and the percentage of states in which they are avail­ able. stipulations or comtsemttj 1000/o 100% probation 98% 100% summary suspension 96% 100% 100% 100% 50% 17% 178. ld. at 32. 179. jd.at35. 180. see fsmb exchange, supra note 163, at tbl.39. 181. 2006 dhhs board study, supra note 69, at 29 exh.16. 2008] the medicare beneficiary complaint process 41 some boards also utilize more creative remedies, such as mentoring or supervision of provider practices, mandatory education programs, limitations on practice, e.g., prescribing. all state medical boards that conduct investigations and engage in disciplinary actions have administrative due process procedures to protect providers. many boards rely on state attorney generals' offices for legal representation in disciplinary cases. 182 as set forth in the medical practice acts in most states, quality of care is the guiding principle behind the state medical boards' role in licensure and dis­ cipline. however, many boards in the 2006 dhhs report commented that the complaint process is reactive, and they would prefer to engage in more proac­ tive quality improvement activities.183 in that report, state medical boards ad­ mitted they are driven by consumer complaints and these complaints result in a large number of costly investigations that lead to few actionable cases.184 the amount of information released to the public regarding investigations and sanctions varies widely among the states. thirty-three out of fifty-one state medical boards issue an annual report that is available to the public and me­ dia.185 additionally, the information in these reports varies greatly. 186 the in­ formation states release to the public about physicians licensed in that state also differs, although most (forty-nine) reveal physicians' disciplinary history.187 state medical boards, however, have come under greater pressure in recent years to release more information to the public. as a result, many states have passed laws requiring increased disclosure, especially regarding physician pro­ files.188 the most salient characteristic of state medical boards (and most problem­ atic for giving boards responsibility to respond to medicare beneficiary com­ plaints) is that they are wholly creatures of state law. the federal government has no power to influence state medical boards to coordinate activities, make reports, or harmonize their activities to fit into a national framework, regardless of whether a board functions independently within a state or as part of the state's health department. for example, the federal law creating the national practitioner data bank189 "requires" boards to report certain adverse actions taken against physicians to a national data bank. 190 although the word "re182. see fsmb exchange, supra note 163, at tbl.39. 183. see 2006 dhhs board snmv, supra note 69, at 44-45. 184. !d. the dhhs board study found that many board members and managers wanted to do more for safety than simply reacting to complaints. some suggested other proactive alter­ natives to complaint-based discipline, including audits of physician practices, non-disciplinary use of clinical assessment centers, and efforts to encourage ongoing maintenance of competen­ cies. id. at 65. 185. see fsmb exchange, supra note 163, at tbl.6. 186. ld. 187. !d. at tbls.40 & 43. louisiana and wyoming are the exceptions. 188. see larsonet al., supra note 169, at 3. 189. see health care quality improvement act of 1986, title iv of pub. l. 99-660, 100 stat. 3784 (codified as amended at42 u.s.c. §§ 11101-11152). 190. see 42 u.s.c. § 11133 (2000). 42 indiana health law review [vol. 5:9 quire., is used throughout the statute and regulations, if a board refuses to transmit the information specified under the law, cms can only designate an­ other qualified entity to report such information. 191· c. combined entity including state survey agency and state medical board given that state survey agencies are limited to dealing only with facility­ based complaints and that medical boards are authorized to deal only with indi­ vidual provider-based complaints, an alternative entity that combines the exper­ tise of state survey agencies and state medical boards in responding to beneficiary complaints but also relies on qios for analyzing the complaints received by these two entities may provide the most effective way to respond to beneficiary complaints. a major problem with the current system is duplication of effort and fail­ ure of coordination among various entities responding to complaints about poor quality health care. complaints are potentially received by a number of agen­ cies, including the sas, the state medical and other health professional boards, qios, the joint commission on accreditation of health care organizations (the "joint commission), the nursing home ombudsman, and medicare con­ tractors. there appears to be little, if any, coordination or sharing of informa­ tion regarding complaints among these agencies. we were surprised to learn that many directors ofsas did not know that qios received beneficiary complaints. as compared to sas and state medical boards, the qios receive significantly fewer complaints. one of the state direc­ tors with whom we spoke said he was unaware that the qio in his state re­ ceived beneficiary complaints. after he learned, :from our inquiry, that this occurred, he called his state qio and asked about the beneficiary complaint process and how many complaints the qio had received in the previous year. the qio staff person said the qio had received l 00 complaints. the sa di­ rector thought this was somewhat comical as his state office receives approxi­ mately l 00 complaints in half a day. clearly, it is the case that the qios do not necessarily share their complaints with the state survey agencies. this is de· spite the fact that some sharing of information is envisioned by the qio man­ ual.192 without a complete picture of the types of complaints that are being 191. see45 c.f.r. § 60.8(a) (2006). 192. according to the qio manual: the state health agency or other appropriate state or local agency used by cms to perform survey/certification and review functions for medicare (the "sa") is not required to refer all complaints to [the qioj that involve quality issues. in some states, it is the law that the sa reviews all com­ plaints it receives. to assist [the qio] and the sa in understanding [the qio's] areas of responsibility, [the qio should] develop a written plan with the sa that explains the types of complaints each will be responsible 2008] the medicare beneficiary complaint process 43 made by consumers about health care institutions and providers, it is difficult for qios or any quality improvement organization to make or recommend mod-· ifications to a system to improve quality and patient safety. an alternative sys­ tem that would require coordination among existing agencies and increase the complaint data going to qios is described below. 1. elements of an alternative complaint entity 1. sas and state medical boards would be designated as the official place for a medicare beneficiary to lodge a complaint about quality of care received. (complaints about non-physician health care provid­ ers, e.g., nurses, therapists, etc., who typically provide care in an insti­ tutional setting, would be handled by the sa.) this may or may not increase the number of complaints these agencies receive. it may also require the state agencies to have a broader scope of complaints over which they have authority to respond, e.g., complaints that are not violations of state licensing standards but meet the review require­ ment standards for medicare beneficiary complaints. 2. sas and state medical boards would investigate all formal complaints, determine if there is a deficiency in the care provided or an issue re­ garding quality of care, determine what type of corrective action is necessary, and work with the institution and/or provider to implement such corrective actions or impose civil monetary penalties or other form of sanctions as appropriate. 3. these agencies would provide individualized responses to complain­ ants via letter, which would include the agencies' findings and any ac­ tion taken. 4. in order to attain some standardization in response practices and con­ sistency across jurisdictions, cms would put in place guidelines for responding to such complaints, similar to those already in place for sas in the cms state operations manual. cms would also monitor performance, as it currently does over certain aspects of sa perform .. ance. 5. state agencies would receive additional funding for these new tasks. 6. each state would designate an individual within the relevant depart­ ment (health, consumer, etc.) to oversee this process and attempt to coordinate efforts of the sa and the professional licensing boards when a complaint involving multiple providers is received. for reviewing, and the exchange of information involving deficiencies in survey and certification requirements or confirmed quality concerns. [the qio should] involve [the qio's] regional office project officer when [the qio] and the sa cannot agree on what types of issues each should review or when there are multiple issues that require project office coordina­ tion/assistance.•• cms, qio manual, supra note 37, § 5015. 44 indiana health law review [vol. 5:9 7. the state agencies would forward all complaints and follow up action taken to the state qio. 8. ideally, other agencies such as the joint commission and medicare contractors would also be required to submit complaints to the qio. 9. the qios would respond to requests from sas and the medical boards for technical assistance, use information about complaints to identify priorities for technical assistance, and work with institutions and providers to implement the necessary changes. 10. qios would share complaint information with the relevant cms re­ gional office. this would ensure that the appropriate regional offices have the relevant information and can feed that information back to the relevant local qios. the regional offices would also have the au­ thority to consider referral to the 010 for sanctions in cases where the state agencies decide not to sanction or to administer additional sanc­ tions beyond those meted out by the state agencies. 11. qios would post uniform data about complaints received by the state entities on their websites so that it would be available to the public. this could take the form of an annual quality report. 12. regional offices would submit all information to a national database. the analysis of data at a national level, using expert panels, is likely to be more effective in identifying quality improvement priorities na­ tionally and regionally. this database would have a structure and classification/nomenclature that would create standardization, allow data analysis for safety/qi and facilitate public reporting. it could also be designed to track timeliness and even include beneficiary sat­ isfaction data. identified priorities could also be shared with local qios for implementation. this alternative is consistent with the recommendation of the iom to shift the review ofbeneficiary complaints from the qios to other entities.193 the iom report argued that this shift should be made for a number of reasons. for example, it would allow qios to focus on quality improvement and perform­ ance measurement which are "incompatible with a strong regulatory func­ tion. "194 moreover, the report points to the small number of complaints received by qios.195 finally, the 10m argues that there are a number of other organizations already responding to consumer complaints and some of them have greater visibility among consumers than the qios. the report specifically states that "[ a]mong the entities considered should be state health departments and the state survey and certification agencies, which already contract with 193. see 2006 10m report, supra note 3, at 113. 194. id. 195. seeid. 2008] the medicare beneficiary complaint process 45 cms to conduct certain functions for the medicare program, including there­ view of all quality-related complaints for nursing homes. "196 2. assessment of alternative complaint entity in evaluating this alternative to qio for receiving and responding to medicare beneficiary complaints we used two sets of criteria. the first are those which the oig called in its 2001 report the "characteristics of an effec­ tive complaint process."197 they include accessibility, investigative capac­ ity, interventions and follow-through, quality improvement orientation, responsiveness, timeliness, objectivity, and public accountability.198 in addi­ tion to these characteristics identified by the 010, we added scope of author­ ity, adequate resources, coordination with other entities, due process (i.e., fairness to the provider), consistency across jurisdictions, and range of re­ sponses/remedies (apology, mediation, quality improvement, compensation, sanctions, etc.) to the list of"effectiveness criteria."199 the combined entity, would fare well on many (though not all) of the cri­ teria relevant for evaluation of a complaint system. below, we assess the alter­ native entity on each of the listed criteria as compared to the qios. accessibility: sas and state medical boards are much more accessible than qios and they already receive a much larger volume of complaints than qios. consumers and beneficiaries are most likely to lodge a complaint with sas and state medical boards. sas are required to have hotlines to receive complaints concerning nursing homes and home health care. we found that states may also have hotlines for other facilities, such as hospitals. investigative capacity: sas employ individuals with health care exper­ tise to survey health care facilities. most often, these individuals are nurses trained by cms and the states. additional medical expertise may be obtained from the state medical board. a few state medical boards already contract with their qios for additional medical expertise. a closer nexus between state agencies and qios regarding complaint activity could facilitate this consulta­ tion process. survey agencies have rapid access to clinical records and broad investigative authority. interventions and follow through: sas and medical boards have many more tools at their disposal than qios to intervene to take corrective action in 196. id. at 115. 197. 2001 010 report, supra note 2, at 6. 198. id. appendix a. infra, includes a description of each of the criteria identified in the 2001 010 report. 199. several of these criteria are described in more detail by a companion paper to this report by peter a. hollmann, m.d. peter a. hollmann, elements and considerations for de­ veloping a medicare beneficiary complaint process to address quality of care concerns: the medical perspective, http://www.medicareadvocacy.org/qioconference/background/back groundpaper.medicalperspective.pdf. 46 indiana health law review [vol. 5:9 response to complaints. they routinely issue deficiency letters and request and monitor corrective action plans. quality improvement orientation: the alternative arrangement would allow qios to do what they do best: identify priorities for technical assistance and suggest changes to improve quality of care. the volume of complaints generated by sas and state medical boards would provide ample data for local, regional and nationwide analysis to discern patterns of poor quality care. a regional and national focus would also allow for a national database and a na­ tional expert panel to analyze the available data. responsiveness: sas and state boards already have systems in place for responding to complainants. cms is improving its oversight of sa responsive­ ness to complaints, which will likely lead to greater responsiveness on the part ofsas. if this alternative arrangement were to be put in place, cms could ex­ pand its oversight of response to beneficiary complaints and provide guidelines similar to those already in place for sas to respond to these complaints. timeliness: both qios and sas have experienced problems in respond­ ing in a timely manner to complainants. sas, however, are being scrutinized by cms on this measure and pushed to improve timeliness of response. state medical boards are perhaps weakest on this measure, in part, because they have no federal timelines with which to comply. objectivity: the proposed arrangement would deal with concerns that have been levied at qios regarding their perceived conflicts of interest. the function of sas and state medical boards is to protect patients from harm. unlike qios, which are required to work closely with providers to change prac­ tice patterns, sas have a singular function, and at least theoretically, do not have the same conflicts that confront qios. in addition, sas, in responding to complaints, often are able to rely on objective criteria and standards set forth in regulations. this is perhaps most true when investigating nursing homes which are heavily regulated. qios, in contrast; must rely on somewhat subjective evaluation by reviewing physicians. by distancing qios from the complaint process they would be able to continue to work closely with health care provid­ ers to make improvements in the system. sas and boards, however, could con­ tinue to play a strong role in enforcement without jeopardizing the quality improvement process. public accountability: the proposed arrangement could also be struc­ tured to allow for greater public accountability by making reports based on ag­ gregate complaint data available to the public. expanding complaint information to be included in a new national database, including all medicare beneficiary complaints, would also improve oversight and public accountabil­ ity. scope of authority: sas and state medical boards have a scope of au­ thority that is at the same time both broader and narrower than qios. sas, for example, have authority to respond to complaints from all patients and consum­ ers regarding care received at health care facilities subject to state licensure re­ quirements. on the other hand, sas are not responsible for responding to 2008] the medicare beneficiary complaint process 47 complaints regarding individual health practitioners. in contrast, state boards are limited to dealing with complaints about individual practitioners and do not address complaints about facilities. qios are limited to responding to com­ plaints by medicare beneficiaries, but such complaints can be about individual practitioners or health care institutions. the combination of state survey agen­ cies and state medical boards would have authority over virtually all medicare beneficiary complaints. adequate resources: while it is unlikely that the shift in responsibility would significantly increase the number of complaints that sas or state medical boards currently receive, this alternative calls for additional funds to be given to these entities to improve their complaint response function. these funds could come from funds now awarded to qios. coordination with other entities: one of the principal advantages of the proposed alternative is the formalization of coordination with other entities within a state. currently, sas handle complaints about institutional providers and routinely refer complaints about individual practitioners to the appropriate state boards; boards handle complaints about individual providers; and qios handle a small number of complaints about both. our proposal would ensure that these groups coordinate their efforts to avoid duplication or contrary ef­ forts. due process: both state medical boards and state survey agencies have due process mechanisms in place to protect practitioners and providers from arbitrary punishment. state medical boards uniformly offer formal notice and appeal procedures to practitioners charged with violation of licensing and disci­ plinary standards. state survey agencies generally have an appeals process in the case of fines or license revocation. the due process procedures of both state agencies would need to be harmonized to ensure procedures were uniform throughout. consistency across jurisdictions: this may be the most significant weakness of this alternative proposal. survey agencies and medical boards vary significantly from state to state, possibly more so than qios, which operate under contracts that conform to a national "scope of work" developed by cms. these variations are likely due to variations in resources and expertise. to some extent, additional resources may help to bring those agencies operating below performance expectations up to applicable standards. in recognition, however, of the possibility that some state agencies may not reach the desired performance standards, cms should have the authority not to utilize a state survey or state board in a given state to respond to beneficiary complaints. cms could keep this responsibility with the qio or designate another entity to fulfill that role. remedies: qios have provided little in the way of remedies to beneficiar­ ies complaining of poor quality care. sas and state medical boards have a much greater range of remedies at their disposal. in addition, the alternative entity would provide an opportunity to expand remedies to complainants. in his testimony before the senate special committee on aging in 1999, mike hash, 48 indiana health law review [vol. 5:9 then deputy administrator ofhcfa, stated that an essential element of a com­ plaint process would be "interactions between complaint investigations and li­ censure and certification systems, the legal system, and facility-level grievance or continuous quality improvement processes . ..200 a more robust complaint system would provide compensation for individuals harmed as a result of poor quality health care. additionally, it would provide beneficiaries with an oppor­ tunity to meet with providers; receive an apology and explanation of what hap­ pened; initiate an investigation of substandard care; and provide compensation to individuals harmed as a result of poor quality health care. such a system, therefore, might incorporate elements of what has traditionally taken place in the courts through medical malpractice litigation. while this would be a revolutionary reform proposal, there are a number of reasons why it might make sense in this context. first, it would allow beneficiaries "one stop shopping." they could file a complaint and have all of their needs and interests met. sec­ ond, it would tie together the medical malpractice system and the quality im­ provement system in a way that has not been possible under the current "silo" based responses to poor quality care.201 the proposed reform would allow for an administratively-based compensation system rather than a trial-based system. the former could allow for an expert panel of reviewers to determine the appropriate level of compensation. ideally, compensation levels would be tied to standards that would provide consistency across similar injuries. criteria for damage payments could be "fault based" or could rely on a broader standard, 200. hash, hearing testimony, supra note 117. 201. william sage and eleanor kinney have proposed the idea of a medicare led reform to the medical malpractice system. see william m. sage & eleanor d. kinney, a malpractice systemformedicare,inmedicalmalpracncerei'orminmeunitfdstates:newcenrury, different issues 318 (william m. sage & rogan kersh eds., 2006); meanor d. kinney & william m. sage, resolving medical malpractice claims in the medicare program: can it be done? 12 conn.ins. l.j. 77, 77 (2005). to the extent that the reform proposal would focus on medicare beneficiaries, sage has provided a number of reasons for the approach. first, hear­ gues that the conventional malpractice litigation process serves medicare beneficiaries very poorly. based on empirical data from texas he asserts that"[ e]lderlypatients file fewer claims and receive lower payments when they do pursue legal action" than do younger patients. wil­ liam m. sage, the role of medicare in medical malpractice reform, 9 j. hbalm carel. & pol'y 217, 221 (2006). he lists several explanations for this disparity: elderly patients tend not to realize that they have suffered negligent inju­ ries. even if they ~gnize a problem, seniors depend on their doctors and hospitals and often do not want to alienate them by filing a lawsuit. if eld­ erly patients do seek redress, their lower remaining life expectancies and reduced employment rates are less likely to generate damages substantial enough to induce lawyers, who are often paid on contingency, to accept them as clients. lawyers also know that it is difficult to settle cases involv­ ing elderly clients because causation of injury is seldom clear-cut in pa­ tients with pre-existing illnesses. nor can elderly clients easily endure the long delays involved in litigation .... id. at 223-24. 2008] the medicare beneficiary complaint process 49 such as avoidable adverse events. beneficiaries could choose whether to pur­ sue the administrative system or the traditional tort system. a final criterion that needs to be considered in this evaluation is the extent to which state survey agencies and state medical boards would be willing to take on this task. the directors of state survey agencies with whom we spoke seemed willing to take on this task. assuming it would be accompanied by addi­ tional resources. in fact, they seemed to think that it was inappropriate that qios were currently handling complaints. we are less certain of the willing­ ness of state medical boards to take this on. many boards are not part of the state's executive branch and operate independently or semi-independently. in addition, while state survey agencies already are partly federally funded and have federal obligations tied to this funding, state medical boards have little to do with federal agencies, except perhaps when dealing with medicare fraud or dea issues like drug diversion which requires working with state and federal prosecutors. cms would likely need to contract with boards to perform this function for additional funding. through such a contract mechanism, cms could specify a uniform complaint process with which the boards would be obliged to comply. state medical boards, however, have been highly resistant to federalization (though more recently they have been undertaking some ac­ tions in coordination with federal agencies like cancer databases and model programs). whether or not additional funding would be sufficient to entice boards to take on this role is unclear. v. conclusion this paper explores the history ofqios and their responsiveness to medi­ care beneficiary complaints regarding the quality of their health care. based on the recent 10m report recommendations that qios may not be the best home for this function, we explore an alternative entity that might take on this func­ tion. this alternative takes advantage of the significant experience and exper­ tise of state survey agencies and state medical boards in responding to patient/consumer complaints about an individual or institutional health care provider. neither the qio nor the proposed alternative is an "ideal" process. each has strengths and weaknesses. for example, qios have significant exper­ tise when it comes to evaluating quality of care complaints; however, they have not been accessible to beneficiaries and often have not provided adequate ex­ planations to beneficiaries about their investigation into allegations of poor quality care. moreover, they have limited authority to implement corrective action and appear to be reluctant to use the authority they do have. as com­ pared to state entities, qios have little experience responding to beneficiary complaints. state survey agencies and state medical boards have significant experience responding to complaints and are very accessible to consumers and patients. they are perhaps "closer to the ground" when it comes to knowing what goes on in different institutions and in the medical community. on the other hand, 50 indiana heal1h law review [vol. 5:9 in many cases they lack the resources to respond to complaints in a timely and thorough manner. while some state survey agencies have excellent systems in place to respond to complaints, including quality improvement systems, others are much less sophisticated in their operations. recent efforts by cms to monitor state agency performance in responding to complaints based on institu­ tional care should improve state agency performance in responding to com­ plaints across the board. the weak link in the alternative entity, however, is state medical boards, which lack cms oversight and, in some states, operate independently of the executive branch. cms could potentially overcome this weakness by contracting with state boards to participate in the complaint re­ sponse process. although we did not evaluate the feasibility of an entirely new entity to handle beneficiary complaints, some of the pros and cons of a new entity are readily apparent. in comparison to the hybrid structure we propose, the new entity would be subject to cms oversight and would likely be adequately funded upon its creation, at least for the first several years. further, the entity would be focused wholly on medicare complaints and would therefore, argua­ bly, have a greater stake in seeking resolution of those complaints and the is­ sues underlying them. in an atmosphere of limited health care dollars, however, it may be impractical to create a new entity that would duplicate the efforts of existing state organizations that are currently charged with complaint investigation and resolution. 2008] the medicare beneficiary complaint process 51 appendix a202 element characteristics of an effective complaint process 1. accessibility complainants are aware of the system and find it easy to use. 2. investigative capacity appropriate experts, resources, and methods are available to assess complaints and determine if they are part of an underlying pattern. 3. interventions and folsubstantiated complaints result in low-through appropriate corrective action. monitoring assures compliance. 4. quality improvement complaints guide quality imorientation provement efforts. 5. responsiveness responses to complainants are regular, substantive, and clear. 6. timeliness each step is completed within an established, reasonable time frame, and mechanisms exist to deal with emergent complaints in an expedited manner. 7. objectivity the review process is unbiased, balancing the rights of each party. 8. public accountability complaint information is made available to the public. 202. 2001 oig report, supra note 2, at 6. indiana iieaitb law review volume4 2007 issue 2 symposium hospital-physician joint ventures: a promising partnership? february 21, 2007 introduction eleanor d. kinney mcdollllld-merrill-ketcham memorilll awud for excellence in law and medicine of doctors and hospitals: setting the analytical framework for managing and regulating the relationship james f. blumstein hospital-physician joint venture relationships: a useful tool to improve hospital services steven h. pratt transcript of live symposium panel discussion james f. blumstein, gregory l. pemberton, norman a tabler, steven h. pratt dennis l. pippenger, m.d. michael j. finnerty notes move over managed care health savings accounts, small businesses, and low wage earners: cost, quality. and access russell b. cate harvesting organs from minors and incompetent adults to supply the nations organ drought: a critical review of the substituted judgment doctrine and the best interest standard beth a. schenberg toward a twenty-first century civil commitment statute: a legal, medical, and policy analysis of preventive outpatient treatment rachel a. scherer letting lilliputians sit at the table: providing physicians with a magnified voice to counter the brobdingnagian hmo brandt r. voight indiana university school of law indianapolis iupui indiana health law review volume4 editor-in-chief lauren n. grattenthaler 2006-2007 executive managing editor rachel a. scherer executive notes editor christopher campaniolo executive production editor russell b. cate executive articles editors raegan m. gibson brandt r. voight executive business editor colleen m. powers note development editors carly s. everett angela k. grogan shannon n. jamison danielle l. kaiser scott j. smith heather a. barnes jacob v. bradley louis j. britton keith a. butler robert w. cochrane matthew v. daley matthew s. dionne mark e. douglas robin e. ebert robert r. elder manjugoel emmal.haw michael j. kyle articles editors brent r. borg shana m. collier bernice v. conway neil f. hazaray david l. nie members faculty advisors lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz associate editors lynn m. eriks chelynne l. harris adam hollander-urbach kimberly a. 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case western reserve university; il.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school ofl..aw. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. wiu1am f. harvey, carl m. gray professor of law & advocacy emeritus. ab., university of missouri; j.d., il.m., georgetown university law school. w. wiulam hodes, professor of law emeritus, ab., harvard college; j.d., rutgers university school of law-newark. wiu1am andrew kerr, professor of law emeritus. a.b., west university; b.s., dulre university; j.d., il.m., harvard law school. wiu1am e. marsh, professor of law emeritus. b.s., jd., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., university oflllinois college of law. kenneth m. stroud, professor of law emeritus. ab., j.d., indiana university­ bloomington. james w. torke, carl m. gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., il.m., george washington university law school. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. dragomircosanici,headofreference. b.a., michigan state university; m.i.l.s., university of michigan; j.d., university of kansas. debradenslaw, reference librarian. b.a., franklin college; m.s., university oflllinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. chris e. long, catalog librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. mahnazk.moshfegh,acquisition/serials librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy,associate director of law library. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyosm orsu, computer system specialist. a.a., parldand college; a.b., m.s., c.a.s., university of lllinois. indiana health law review volume4 issue 2 table of contents symposium hospital-physician joint ventures: a promising partnersidp? february 21, 2007 introduction ............................................................. eleanor d. kinney 205 mcdonald-me"ill-ketchom memorilll award for excellence in law and medicine of doctors and hospitals: setting the analytical framework for managing and regulating the relationship ..................................................... james f. blumstein 209 hospital-physician joint venture relationships: a useful tool to improve hospital services .......... steven h pratt 239 transcript of live symposium panel discussion .................................. james f. blumstein, gregory l. pemberton, norman g. tabler, steven h pratt, dennis l. pippenger, m.d., & michael j. finnerty 263 notes move over managed carehealth savings accounts, small businesses, and low wage earners: cost, quality, and access .............................................................. russell b. gate 287 harvesting organs from minors and incompetent adults to supply the nation's organ drought: a critical review of the substituted judgment doctrine and the best interest standard ....................................... .beth a. schenberg 319 toward a twenty-first century civil commitment statute: a legal, medical, and policy analysis of preventive outpatient treatment ...................... rachel a. scherer 361 letting lilliputians sit at the table: providing physicians with a magnified voice to counter the brobdingnagian hmo ......................................... brandt r. voight 435 2007 microsoft word 1-masthead vol. viii.doc nanotechnology: how voluntary regulatory programs can both ease public apprehensions and increase innovation in the midst of uncertain federal regulations katie miller* i. introduction ............................................................................... 436 a. types of nanotechnology ......................................................... 438 b. the issue: regulating nanotechnology ................................... 440 ii. background information ......................................................... 442 a. nanotechnology’s possible problems ...................................... 442 b. current outlook ....................................................................... 444 1. available funding for nanotechnology ............................ 444 2. societal interest in nanotechnology .................................. 445 3. public confidence and perceptions .................................. 446 iii. federal regulations ................................................................. 447 a. existing debate concerning regulation.................................. 447 1. environmental protection agency: toxic substances control act ........................................................................ 448 2. food and drug administration: federal food drug and cosmetic act ............................................................... 449 3. occupational safety and health administration ............... 449 4. consumer product safety act ............................................ 450 5. other sources .................................................................... 451 b. why federal regulations for debate?..................................... 451 c. problems with existing regulations―short-term and long-term ................................................................................. 454 iv. voluntary regulatory programs......................................... 457 a. proposal for state level voluntary regulatory program........ 457 b. existing voluntary programs in other industries ................... 459 c. advantages of voluntary program .......................................... 462 1. innovation .......................................................................... 463 2. public perceptions ............................................................ 463 3. health and safety .............................................................. 464 4. incentives for firm participation ...................................... 465 d. disadvantages of voluntary program ..................................... 465 e. how a state level program would look................................. 467 v. conclusion .................................................................................. 469 436 indiana health law review [vol. 8:2 i. introduction “nanotechnology is so new and so untested for potential effects on human health that we do not even know what we don’t know.”1 dr. philip landrigan, director of the children’s environmental health center at mount sinai school of medicine, was correct in identifying that the problem of nanotechnology is a complete lack of knowledge, not only on the part of the government and researchers, but also on the part of the public in general.2 this lack of knowledge exists as to the potential effects, benefits, uses, and regulations necessary for new nano-containing products. nanotechnology is an emerging field concerned with many different kinds of nanoparticles that are each inherently different.3 research involving nanoparticles has been conducted since the 1980s, though the concept of nanotechnology was first discussed at a caltech american physical society meeting in 1959.4 in 2001, the national nanotechnology initiative (“nni”) was established to focus research efforts on nanotechnology.5 the nni was established by executive order under the auspices of the nanoscale science, engineering and technology (“set”) subcommittee of the national science and technology council.6 the nni is made up of twenty-six7 u.s. federal agencies including both the food and drug administration (“fda”)8 and the environmental protection agency (“epa”).9 there * j.d. candidate, 2011, indiana university school of law—indianapolis; b.s., 2008, purdue university krannert school of management; b.s., 2008, purdue university school of science. 1. steven higgs, mama, dada, and nano? subparticles may be toxic for kids, the progressive, oct. 2009, at 18. 2. see id.; see also rory o’neill, dangers come in small particles, hazards, july– sept. 2004, at 16, available at http://www.hazards.org/nanotech/nanotechsafety.pdf. 3. ronald sandler & w. d. kay, the national nanotechnology institute and the social good, 34 j.l. med. & ethics 675 (2006) (describing the future of nanotechnology as “a future in which the ability to understand and control matter on the nanoscale leads to a revolution in technology and industry.”). 4. history and future of nanotechnology, nanotechnology res. found., http://www.nanotechnologyresearchfoundation.org/nanohistory.html (last visited oct. 17, 2010). 5. nastassja lewinski, nanomaterials: what are the environmental and health impacts?, chem. eng. progress, dec. 2008, at 37. see generally what is nanotechnology?, nat'l nanotechnology initiative, http://www.nano.gov/html/facts/whatisnano.html (last visited oct. 17, 2010). 6. 15 u.s.c.a. § 7504 (west 2003); see also exec. order no. 12,881, 58 fed. reg. 62491 (nov. 23, 1993), available at http://www.archives.gov/federal-register/executiveorders/pdf/12881.pdf. 7. see jordan paradise et al., developing oversight frameworks for nanobiotechnology, 9 minn. j. l. sci. & tech. 399 (2008); government departments and agencies, nat'l nanotechnology initiative, http://www.nano.gov/html/about/nniparticipants.html (last visited feb. 16, 2010). 8. see generally nanotechnology, u.s. food and drug administration, http://www.fda.gov/scienceresearch/specialtopics/nanotechnology/default.htm (last updated may 21, 2010). 2011] nanotechnology and voluntary regulatory programs 437 is no set definition of nanotechnology, but according to the nni, the working definition includes: (1) [r]esearch and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range; (2) creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size; and (3) ability to control or manipulate at the atomic scale.10 to put this into perspective, one nanometer is one one-billionth of a meter, and a single strand of hair is 75,000 nanometers in diameter.11 further, it takes ten hydrogen atoms, the smallest element on the periodic table, lined up end-to-end to equal one nanometer.12 the current state of the nanotechnology industry is such that scientists are uncertain of what happens when humans breathe, absorb, or ingest engineered nanomaterials.13 it has yet to be researched exactly where nanomaterials go in the body and what, if any, effects nanoparticles may have on the health of the human body. if those working directly with nanocontaining products and technologies lack complete knowledge, what chance does the government have in enacting proper regulations? moreover, what chance does the public have in understanding the risks and benefits of nanotechnology that could, and in many cases do, affect their everyday lives? this note proposes a state level voluntary regulatory scheme for regulating nanotechnology. this voluntary program is proposed to only be used until nanotechnology-specific federal regulations are enacted. first, is a discussion of the different types of nanotechnology and potential problems associated with each. second, this note addresses the public perceptions of nanotechnology and the current outlook in the industry. third, is an outline of the existing debate over federal regulations and which regulations are being considered. fourth, is a description of the proposed state level voluntary regulatory scheme. finally, this note explains other successful voluntary regulations and why a similar scheme for nanotechnology will work. 9. the epa is concerned with the effects of nanotechnology on the environment and supports nanotechnology research. nanotechnology, u.s. environmental protection agency, http://www.epa.gov/ncer/nano (last updated feb. 3, 2010). 10. see paradise et al., supra note 7. see generally nat'l nanotechnology initiative, http://www.nano.gov (last visited feb. 10, 2010). 11. james brindell, nanotechnology and the dilemmas facing business and government, 83 fla. b.j. 73, 73 (2009). 12. id. 13. see regulating nanotechnology: a hardnose look, nanoparticle news, feb. 1, 2006, available at 2006 wlnr 24068236. 438 indiana health law review [vol. 8:2 a. types of nanotechnology nanomaterials come in many different shapes and sizes. several types of nanomaterials are currently being used in research and can be found in every day consumer products. each of these types of nanomaterials has different properties, and thus poses different risks. nanomaterials can be produced in two ways. they can be produced using either a “bottom up” or “top down” process.14 “bottom up manufacturing is the creation of nanomaterials from atoms and molecules.”15 in contrast, “[t]op down manufacturing is the creation of nanomaterials from their macro-scale counterparts . . . .”16 top down manufacturing is achieved through several processes, with milling being the method most commonly used.17 the principal use of nanomaterials is in drug delivery systems. for this function, gold nanoparticles are used. gold nanoparticles “provide attractive vehicles for pharmaceutical delivery applications as a result of their size and the unique properties and release mechanisms.”18 massachusetts institute of technology, for example, has used gold nanoparticles and infrared light to develop a drug delivery system that allows multiple drugs to be released in a controlled fashion.19 gold nanoparticles are effective for drug delivery systems because they melt and release the drugs that are attached to their surfaces when exposed to infrared light.20 nanoparticles of different shapes respond slightly differently depending on infrared wavelengths so that just by controlling the wavelengths, the drug release time can be deliberately chosen.21 nanosilver is engineered for its anti-bacterial properties, and thus is widely found in clothing, children’s toys, cosmetics, and cleaning products.22 because nanosilver is believed to be non-toxic, there is little concern over its use in daily products. in fact, nanosilver is the most widely used nanomaterial in production.23 one possible problem that researchers have identified relating to nanosilver is that the particles may interfere with dna 14. paul c. sarahan, nanotechnology safety: a framework for identifying and complying with workplace safety requirements, 5 nanotechnology l. & bus. 191, 192 (2008). 15. id. 16. id. 17. milling is a solid-state process. robert dowding & delcie durham, national materials advisory board, national research council, summary of the workshop on structural nanomaterials 3 (national academy press 2001), available at http://www.nap.edu/catalog.php?record_id=10253. 18. gang han, et al., drug and gene delivery using gold nanoparticles, 3 nanobiotechnology 40, 41 (2007). 19. mass. inst. of tech., gold nanoparticles for controlled delivery, sci. daily (jan. 6, 2009), http://www.sciencedaily.com/releases/2008/12/081231005359.htm. 20. id. 21. id. 22. see higgs, supra note 1. 23. id. 2011] nanotechnology and voluntary regulatory programs 439 replication fidelity and bind with dna.24 there is also a slight concern that the particles may disrupt energy production pathways for cells and cytotoxicity.25 though these effects are considered “non-toxic” by researchers, interference with dna replication and energy production pathways should be deemed to be severe side effects, regardless of how attenuated. carbon nanotubes are cause for the most concern. these microscopic carbon fibers were discovered by researchers in scotland to be responsible for the “same kind of cancer-causing cellular damage in mice as asbestos.”26 the tiny nanotubes are long-thin fibers, much like asbestos.27 thus, inhaled nanoparticles may penetrate into the lungs causing damage, and studies have documented the adverse health impacts of these tiny particles on rats.28 it is possible that the same could occur in humans. regardless, nanotubes are still used because they conduct heat and transmit electricity extremely well, and have improved strength and hardness over many current materials.29 current applications include high-efficiency chemodelivery systems and super-strong mountain bike handlebars.30 other less common nanomaterials include buckyballs,31 diamond nanoparticles,32 iron nanoparticles,33 and silica nanoparticles,34 and each of 24. nanosilver may directly interact with dna polymerases, which are necessary for dna to properly duplicate. michael berger, nanosilver used in food storage materials found to interfere with dna replication, nanowerk (feb. 19, 2009), http://www.nanowerk.com/spotlight/spotid=9340.php. 25. id. 26. elie dolgin, states struggle to deal with nanotech health concerns: fine particles could damage cells, milwaukee j. sentinel, june 25, 2008, at a1; see also kevin rollins, nanobiotechnology regulation: a proposal for self-regulation with limited oversight, 6 nanotech. l. & bus. 221, 224 (2009). 27. asbestos, u.s. envtl. prot. agency, http://www.epa.gov/asbestos (last updated june 18, 2010). 28. see sarahan, supra note 14, at 192-93. see also rollins, supra note 26, at 224. 29. sarahan, supra note 14, at 192. 30. michael snyder, indiana’s nanotechnology revolution – a world leader?, inside ind. bus., http://www.insideindianabusiness.com/contributors.asp?id=1235 (last visited feb. 10, 2010). 31. buckyballs, aka buckminsterfullerenes, are hollow, spherical molecules made of carbon. res. and dev. of the u.s. dept. of energy, richard e. smalley, buckminsterfullerenes (the buckyball), and nanotubes, off. of sci. and technical info. of the u. s. dept. of energy, http://www.osti.gov/accomplishments/smalley.html (last visited feb. 10, 2010). 32. diamond nanoparticles may have significant uses as drug carriers, nanorobots, and other medical applications. am. chem. soc’y, easing concerns about the toxicity of diamond nanoparticles, sci. daily (jan. 2, 2007), http://www.sciencedaily.com/releases /2007/01/070101113457.htm. 33. iron nanoparticles may be used in power-transformer cores and magnetic storage media. lin guo et al., iron nanoparticles: synthesis and applications in surface enhanced raman scattering and electrocatalysis, 3 j. phys. chem. chem. phys. 1661, 1661 (2001). 34. silica nanoparticles are being researched for cancer detection purposes. detecting cancer with silica nanoparticles, physorg.com (sept. 18, 2006), http://www.physorg. com/news77816615.html. 440 indiana health law review [vol. 8:2 these may present dangerous risks to humans.35 many of these conclusions are yet to be known due to the slow progress in nanotechnology research. b. the issue: regulating nanotechnology regulating nanotechnology is a difficult task because the effects of nanomaterials are not completely known. in addition, the concerns of the government, industry professionals, and the public must all be considered. a voluntary regulatory scheme can address these concerns in the short-term while sufficient federal regulations are crafted. as dr. landrigan alluded to, the problem of nanotechnology is much like a vicious circle, caused by a lack of knowledge across the board.36 the circle starts with the mutual desire to release product improvements onto the market for consumer's enjoyment and companies' profit.37 for this to occur, two things must first happen. one, the government has to allow the product onto the market.38 two, consumers have to buy the products to benefit from them. in order for consumers to purchase the product, most need to know, or at least feel, that the product is both safe and effective. consumers are reassured products are safe based on governmental testing that warrants the products have gone through adequate testing.39 in the case of nanotechnology, there are no specific regulations or safety standards because to enact new regulations, the government requires complete information on safety and effectiveness.40 as noted, the safety of nanomaterials is yet to be known.41 to determine the necessary safety information, companies and universities need research funds. companies, however, cannot expend mass amounts on research if they are not gaining profits from products on the market. additionally, much of the important data is collected once the public starts to use the product.42 without regulations, the public is unlikely to support the industry. without regulations, companies cannot keep producing. nevertheless, 35. rollins, supra note 26, at 225. 36. see part i. 37. see generally michael spence, production selection, fixed costs, and monopolistic competition, 43 rev. econ. stud. 217, 217 (1976) (providing information on economic analysis). 38. see generally 21 u.s.c. § 301(c) (2006) (under the food and drug administration’s federal food, drug, and cosmetic act, products may be required to go through a premarket testing process. without testing, the product is not allowed on the market.). 39. jordan paradise et al., evaluating oversight of human drugs and medical devices: a case study of the fda and implications for nanobiotechnology 37 j.l. med. & ethics 598, 600 (2009). 40. id at 603-04. 41. id. 42. see generally david austin & colin baker, cong. budget off., econ. and budget issue brief: pharmaceutical r&d and the evolving market for prescription drugs (2009), available at http://www.cbo.gov/ftpdocs/106xx/doc10681/1026-drugr&d.pdf (in the pharmaceutical industry, important data is collected during clinical trials.). 2011] nanotechnology and voluntary regulatory programs 441 without companies producing, the government cannot gain enough information to set regulations. in the case of nanotechnology, the government, consumers and industry all lack adequate knowledge.43 this cycle must be broken so the potential of nanotechnology can be realized. because nanotechnology is so new, there is an opportunity “for us to get it right from the start.”44 thus, because there are currently no specific regulations in place for nanotechnology, new regulations can be set to both encourage production using nanomaterials to their fullest potential while also ensuring the public is safe from possible harms.45 focusing too much on either issue is unlikely to be sufficient. as discussed later in this note, there is no applicable regulatory scheme into which nanoparticles “fit.”46 though existing regulations are currently applied to the nanotechnology industry, none are sufficient to achieve public health reassurance and continue to incentivize innovation.47 if a new regulatory scheme is to be crafted from scratch, now is the time to be cognizant of all relevant considerations, rather than simply tweaking the already pre-existing regulations. to “get it right from the start” will undoubtedly take time and resources that many innovative companies may not be capable of expending.48 not only does creating a new regulatory scheme take time, but the current debate over how to structure the regulations or whether regulations are even needed in the first place, causes delay.49 thus, the process is moving slowly toward a final decision on whether, and how, to regulate. however, negative experiences with materials such as cfcs,50 pcbs,51 and asbestos52 43. james yeagle, nanotechnology and the fda, 12 va. j.l. & tech. 6, 65 (2007). 44. see regulating nanotechnology, supra note 13. 45. id. 46. see paradise et al., supra note 7. 47. id. 48. robin wilson, nanotechnology, the challenge of regulating known unknowns, 34 j.l. med. & ethics 704, 711 (2006) (highlighting the low amount of capital for many nanotech start up companies). 49. see higgs, supra note 1. 50. chlorofluorocarbons (“cfcs”) are catalytic agents in ozone depletion. however, they were originally ideal for many applications because they are non-toxic to humans, nonflammable, and non-reactive with other chemical compounds. ciesin thematic guides: chlorofluorocarbons and ozone depletion, center for int'l earth sci. info. network (“ciesin”), http://www.ciesin.org/tg/oz/cfcozn.html (last visited feb. 10, 2010). 51. the production of polychlorinated biphenyls (“pcbs”) was banned in 1979 due to their high toxicity. however, they were originally ideal for electrical, heat transfer, hydraulic, plastic, and paint plasticizer applications because of their non-flammability, chemical stability, and high boiling point. polychlorinated biphenyls, u.s. envtl. prot. agency, http://www.epa.gov/epawaste/hazard/tsd/pcbs/index.htm (last updated dec. 6, 2010). 52. asbestos’ microscopic fibers that are released into the air can be inhaled into the lungs, causing significant health problems. though the use of asbestos is now banned, the mineral fiber was originally used for many years in building construction materials and as a fire retardant. initial testing of asbestos demonstrated its fiber strength and heat resistant properties before negative health effects were discovered. see asbestos, supra note 27. 442 indiana health law review [vol. 8:2 suggest it would be wise to discover and address any potential negative health and environmental effects before the use of nanomaterials becomes widespread. the problems caused by asbestos have become infamous in the united states. asbestos, originally a breakthrough technology, had risks that were not realized until many years later when cases of mesothelioma53 emerged in people who spent substantial time around products containing asbestos.54 to add to the confusion, not only are the effects of nanotechnology unknown, but also the nni only has an incomplete inventory of what nanomaterials are even in production and use.55 as products are released onto the market without sufficient regulations the innovative company is not who society should be worried about. while an uncertain regulatory scheme may lead companies to choose between innovation and facing uncertain risks (and ultimately uncertain liability), consumers are in danger of being harmed by unsafe and untested products. many consumers are unaware that some of the products they use daily may contain nanoparticles.56 something can be done in the meantime, however. voluntary regulations can serve to foster innovation, work toward a proper regulatory scheme, and calm consumer apprehensions regarding products containing nanotechnology. a voluntary regulatory scheme, such as the one proposed in this note, would not replace eventual federal regulations. instead, voluntary regulations can be used to fill the gap, while waiting to decide which existing federal regulations to apply, or whether to craft new regulations. ii. background information a. nanotechnology’s possible problems though much speculation exists that nanomaterials are harmful, the full picture as to what extent of harm nanomaterials may cause has yet to be drawn. a voluntary regulatory program can incentivize research into the possible problems associated with nanomaterials. 53. most people with mesothelioma worked with, or lived near, asbestos. mesothelioma is caused when cancer cells are found in the sac lining the chest, the lining of the abdominal cavity, or the lining around the heart. as little as two to three months of exposure of asbestos can cause mesothelioma. malignant mesothelioma, nat’l cancer inst., http://www.cancer.gov/cancertopics/types/malignantmesothelioma (last visited feb. 10, 2010). 54. many of those affected by asbestos were factory workers who worked producing the asbestos-containing products, and those that lived near the industries. see asbestos, supra note 27. 55. see nastassja lewinski, nanomaterials: what are the environmental and health impacts?, chem. eng. progress, dec. 2008, at 37. see generally education and workforce needs, nat'l nanotechnology initiative, http://www.nano.gov/html/society/ education.html (last visited jan. 5, 2011). 56. see higgs, supra note 1. 2011] nanotechnology and voluntary regulatory programs 443 even now, there are concerns being raised about the hazards of nanotechnology.57 however, safety groups argue that the reason these have not been quickly addressed is that “[d]ollar signs have blotted out the warning signs.”58 because it is expensive to research possible effects of a new technology, the warnings are ignored in order for profits to be achieved. for a study to be conducted effectively, large population samples must be used, as well as trials that span long periods of time.59 according to nanotechnology special interest groups, there is a sense of urgency for innovative companies to release products containing nanomaterials.60 it has become a “modern-day gold-rush—forget precaution, get to production . . . . we might not know for certain whether nanotech will make you sick, but industry knows it can certainly make you rich . . . .”61 the potential ability of nanoparticles to enter cells because of their small size is what makes them toxic.62 in addition, nanomaterials have a larger surface area to volume ratio than many particles, which leads to greater reactivity.63 initial studies conducted by the epa have shown that certain nanomaterials have the ability to pass through cell membranes or cross the blood-brain barrier in ways that larger scale materials cannot.64 currently, these adverse health effects have been documented in both mice and fish.65 scientists have conducted testing on fish to ascertain toxicity data.66 the nanoparticles affected the gills of the fish,67 which suggests that as the size and shape of nanoparticles can penetrate gills, they may also be able to penetrate human skin, though it is too early to tell at this point.68 research also seems to suggest that the different shapes of nanoparticles are 57. john monica jr. et al., preparing for the future health litigation: the application of products liability law to nanotechnology, 3 nanotech. l. & bus. 54, 54 (2006). 58. id. at 55. 59. see benjamin zycher et al., center for medical progress at the manhattan institute, no. 6, the truth about drug innovation: thirty-five summary case histories on private sector contributions to the pharmaceutical science (2008), available at http://www.manhattan-institute.org/pdf/mpr_06.pdf. 60. monica et al., supra note 57, at 55. 61. id. 62. see liz kalaugher, nanoparticle size affects uptake by cells, nanotechweb .org (mar. 17, 2006), http://www.nanotechweb.org/cws/article/indepth/24455. 63. reactivity increases where there is more space for a second molecule to bind. as the surface area increases, without increasing the volumic weight, the potential space for a second molecule to bind increases. see generally k. kuo & h. marsh, active surface area on carbon reactivity, 34 amer. chem. soc., div. fuel chem. preprints 153 (1989), available at http://www.anl.gov/pcs/acsfuel/preprint%20archive/files/34_1_dallas_0489_0153.pdf. 64. sarahan, supra note 14, at 192-93. 65. rick weiss, nanoparticles toxic in aquatic habitat, study finds, wash. post, mar. 2, 2004, at a2. 66. see effects of nanotechnology on health and environment, the med. news (jan. 30, 2007), http://www.news-medical.net/news/2007/01/30/21628.aspx. 67. id. 68. id. 444 indiana health law review [vol. 8:2 responsible for the various adverse affects.69 accordingly, university of florida toxicologist, david barber, noted that if different effects are felt every time a nanoparticle changes shapes, the regulatory burden will be great.70 additionally, in august 2009, the deaths of two female factory workers in china were allegedly linked to adverse effects of nanotechnology at a factory that produced paint containing nanomaterials.71 the two girls died from lung damage similar to that seen in asbestos-related mesothelioma victims, while seven others suffered severe effects.72 the precise reason for the deaths has not yet been released, but the possibility that nanoparticles could cause these kinds of effects is cause for alarm. an across-the-board policy or regulatory scheme does not make sense for nanotechnology.73 each type of nanomaterial has different uses and structures that require specific consideration. in addition, as nanomaterials change size (as a macro molecule is transformed to the nano-scale) the properties of the material change even when the composition stays the same.74 these considerations make any hasty regulatory decision unwarranted. however, a purely precautionary approach should not be taken either because a “better safe than sorry” outlook forces innovative companies to come to a standstill, decreasing innovation and possibly forcing them out of business.75 accordingly, a voluntary regulatory scheme may ease the feeling that regulations should be established without due thought. the industry can regulate itself in the interim and ideally gather information for the federal government to make the permanent regulatory decision. b. current outlook progress in the nanotechnology field depends on “societal interest, available funding, and ultimately public confidence” in the technology.76 1. available funding for nanotechnology it appears that governmental interest and funding is in full force to 69. id. 70. id. 71. see timothy malloy, nanoparticles potentially linked to factory worker deaths in china, legal planet the envtl l. and pol'y blog, berkeleylaw/ucla law (aug. 20, 2009), http:// legalplanet.wordpress.com/2009/08/20/nanoparticles-potentially-linked-tofactory-worker-deaths-in-china/. 72. id.; see also xu chao, trail of death leads doctors to nanoparticles, cajing mag. (sept. 24, 2009), http://english.caijing.com.cn/2009-09-24/110259731.html. 73. see dolgin, supra note 26. 74. see generally nanofacts, nanomaterials company, http://www.nano materialscompany.com/nanofacts.html(last visited jan. 5, 2011). 75. wilson, supra note 48, at 710. 76. see paradise et al., supra note 7, at 411. 2011] nanotechnology and voluntary regulatory programs 445 achieve the nni’s vision of an industrial and technological revolution.77 united states federal funding for nanotechnology research and development “has increased from approximately $464 million in 2001 to nearly $1.5 billion for the 2009 fiscal year.”78 in fact, the number of researchers in the field of nanotechnology is expected to increase ten thousand percent in the next fifteen years.79 by 2014, it is estimated that products containing nanotechnology will represent $2.6 trillion in manufactured goods and nearly fifteen percent of global manufacturing.80 nanotechnology is projected to be a major part of not only the future of the united states, but of the global market as a whole. it is more important than ever to construct a regulatory scheme that encourages innovation and will protect potential consumers from adverse effects. 2. societal interest in nanotechnology nanotechnology has the ability to revolutionize many commercial and medical industries. the principal use of existing nanotechnology is drug delivery applications.81 using nanotechnology to deliver drugs to the body provides for increased drug efficacy and an increased ability to target specific cells.82 if the projections regarding the benefits of nanotechnology are true, neither innovative companies nor consumers will have a desire for production to come to a complete halt. new developments are made every day in the field of nanotechnology. for example, chad mirkin from the massachusetts institute of technology found a way to use nanomaterials to identify “low concentrations of disease-signifying molecules.”83 accordingly, despite large data gaps, drug companies are not easily persuaded to stop research and production of 77. see funding, nat'l nanotechnology initiative, http://www.nano.gov/ html/about/funding.html (last visited oct. 23, 2010) (listing the 2011 nni budget at $1.8 billion dollars). 78. rollins, supra note 26, at 222. 79. id. 80. id. 81. id.; see also majeti n.v. raul kumar, nano and microparticles as controlled drug delivery devices, 3 j. pharm. pharm. sci. 234 (2000) (stating that nanotechnology is used in drug-delivery applications by attaching a drug to a nanoparticle which allows scientists to use the favorable properties of nanoparticles to target specific cells). 82. rollins, supra note 26, at 222; see also drug action: drug dynamics: merk manual home edition, merk & co., inc., http://www.merck.com/mmhe/sec02/ch012/ ch012c.html (last updated nov. 2007) (“efficacy is the capacity to produce an effect. in a drug context, efficacy is the ability of a drug-receptor complex to produce a functional response. the small size of nanoparticles, along with the increased surface area to volume ratio makes nanoparticles ideal to bring about these sought after effects.”). 83. see press release, lemelson-mit program, world-renowned nanotechnology expert proves there is big potential in the smallest of matter (june 24, 2009), available at http://web.mit.edu/invent/n-pressreleases/n-press-09lmp.html. 446 indiana health law review [vol. 8:2 nano-containing products completely, and government is reluctant to impose regulatory requirements.84 until all the potential effects of nanotechnology are known, regulators are unclear on how to move forward with nanotechnology regulation.85 accordingly, a framework needs to be in place that allows for flexibility. innovation and regulation need to co-exist in the interim until a concrete federal regulatory scheme is developed. a flexible scheme such as a voluntary program can allow innovators to weigh the benefits and costs of production before research is complete. at the same time, a voluntary scheme can aid regulators in choosing the proper regulations for the long-term. implementing broad regulations immediately can start the process towards refinement and narrowing of the regulatory scope over time. 3. public confidence and perceptions for the full effect of nanotechnology to be realized, the public must perceive it to be useful and safe. according to alan gotcher, ceo of altair nanotechnologies, opinions regarding nanotechnology may be framed from a position of “uninformed fear,” resulting in the presumption that nanotechnology is bad.86 gotcher’s opinion may be indicative of a general attitude in society that emerging technologies always get ahead of ethical, social, and legal reflections.87 the new technology in many cases has to prove itself before it is widely accepted. articles such as “mama, dada, nano? subparticles may be toxic for kids” impute fear into the public.88 the above article claims that nanomaterials are present in many household products, and may have negative effects on children.89 in fact, it is hard for consumers to know whether an item contains nanoparticles as many products do not use nanotechnology as their marketing tool. nanoshop.com is one example of a website that is devoted solely to nano-containing products.90 nanoshop.com sells glass, metal, and concrete treatment products, all containing various nanotechnology.91 84. see brindell, supra note 11, at 74. 85. see id. 86. see regulating nanotechnology, supra note 13. 87. id. 88. see higgs, supra note 1. 89. id. 90. see generally nanoshop, http://www.nanoshop.com (last visited oct. 25, 2010). see also ann fernholm, consumers not always aware of presence of nanotechnology, s.f. chron., may 12, 2008, at d3, available at 2008 wlnr 8904538 (stating that “customers can find a softener for baby cloths and underwear containing nanosilver, in addition to antimicrobial paint and a shoe deodorizer.”). 91. see, e.g., nanoshop, supra note 90. 2011] nanotechnology and voluntary regulatory programs 447 public alarm and strong concerns regarding new technologies have become known as “social shocks.”92 social institutions grapple with the problem for varying amounts of time while “papers on effects increase[] in the technical literature.”93 astoundingly, the delay between innovation and social acceptance, on average, can be as much as one to two decades.94 news stories are not only increasingly concerned with the effects of nanotechnology, but are also critical of the government’s regulatory abilities, as the number of u.s. risk-focused stories rose fifty-eight percent from 2005-2006 alone.95 this is important as many consumers gather pertinent information from both the local and national media. the question posed by news stories is whether the government is even up to the job of nanotechnology oversight--whether twentieth-century regulations are ready for a twenty-first-century technology. iii. federal regulations current federal regulations are insufficient to regulate nanotechnology. as it takes time to design a new regulatory scheme, a voluntary regulatory program can step in to allow industry to regulate itself in the interim. a. existing debate concerning regulation the current debate around nanotechnology centers on whether existing regulations set by agencies such as the fda and the epa are sufficient to handle the new technology.96 prominent figures in nanotechnology research and regulation readily disagree on this point. neil desai, ph.d., vice president of research and development at abraxis biosciences, says that there are no new or unique toxicities involved in the use of nanoparticles to deliver drugs.97 therefore, the regulations in place are sufficient. however, piotr grodzinski, ph.d., director of nanotechnology cancer programs at the nci alliance for nanotechnology in cancer, disagrees.98 he believes the “multifunctional properties of some nanoparticles . . . used to deliver both diagnostics and treatments,” coupled with the high level of in 92. igor linkov et al., nano risk governance: current developments and future perspectives, 6 nanotechnology l. & bus. 203, 206 (2009). 93. id. 94. id. 95. see press release, the pew charitable trust, nanotechnology regulators make news (dec. 18, 2007), available at http://www.pewtrusts.org/news_room_detail .aspx?id=32490. 96. mark mccarty, many calls for new nano regs not likely to be heeded soon, medical device daily, october 13, 2006, available at 2006 wlnr 17855392. 97. id. 98. id. 448 indiana health law review [vol. 8:2 novation in the nanotechnology sector, are important considerations.99 thus, according to grodzinski, a new regulatory scheme is needed.100 though these types of debates over a proper regulatory scheme have continued since 2001, no conclusion has been reached and the debate drags on. if desai and grodzinski are indicators, it seems much of the line in this debate is drawn between researchers and industry professionals. researchers push for new regulations because they realize the potentially unique properties of nanotechnology, and are driven from a profit-making perspective. on the other hand, those who work for innovative companies will likely prefer to use existing federal regulations and adapt them to nanotechnology. while innovative companies ideally prefer no regulation, this is not a viable choice. federal regulations are viewed by the innovative company as reliable because the company knows what each agency looks for, as they have dealt with the regulations in the context of other products.101 the company, therefore, does not have to learn new terms and requirements. instead, they simply have to apply those standards to nanotechnology. additionally, merely modifying existing regulations is likely to end the debate more quickly. the existing regulations being considered include the epa toxic substances control act (“tsca”),102 the fda federal food, drug, and cosmetic act (“fdca”),103 occupational safety and health administration (“osha”) standards,104 the consumer products safety act (“cpsa”),105 and combinations of these. 1. environmental protection agency: toxic substances control act the epa’s tsca regulates chemical substances that may be dangerous to the environment.106 the tsca has the ability to regulate new chemical substances; that is, there are separate regulations for new chemicals beyond those listed in the existing chemical inventory.107 some scholars believe that this “new chemical” provision can be used to regulate products containing nanoparticles.108 however, andrew maynard, science advisor 99. id. 100. id. 101. for example, if the toxic substances control act (“tsca”) is used to regulate nanotechnology, companies will be familiar with the provisions as the tsca regulates other known hazardous chemicals the company may produce. see generally 15 u.s.c. §§ 2601-29 (2006). 102. id. 103. see generally 21 u.s.c. §§ 301–99 (2006). 104. see generally 29 c.f.r. § 1910 (2010). 105. see generally 15 u.s.c.a. §§ 2051–89 (west 2010). 106. see 15 u.s.c. §§ 2601-29. 107. 15 u.s.c. § 2605 (2006). 108. news release, epa foregoes opportunity to improve nanotechnology oversight, woodrow wilson int’l ctr. for scholars (july 12, 2007), available at 2011] nanotechnology and voluntary regulatory programs 449 for the project on emerging nanotechnologies, stated that the approach taken by the epa ignores research that states “different nanostructures with the same molecular identity present different hazards.”109 the question to be answered is whether nanoparticles can actually be considered new chemicals or whether they are completely different and, thus, whether the existing method of tsca regulation is sufficient. for example, tsca will regulate only if the molecular identity of a particular nanoparticle is different from the molecular identity of the macroparticle of the same material that is on tsca’s inventory list.110 2. food and drug administration: federal food drug and cosmetic act the fda generally regulates on a product-by-product basis, subjecting each new product to rigorous testing before it is approved to be released on the market.111 products are “often categorized according to the mode of action, and uses intended by the manufacturer.”112 the fdca regulates new drugs through a “pre-market testing and approval process,” along with meeting “safety, efficacy, and manufacturing standards.”113 devices determined to be of a higher-risk must go through an application process showing they are both safe and effective before they can be put on the market, while lower-risk products may be marketed if shown to be substantially similar to a product already on the market.114 a report released by the nanotechnology task force concluded that the fda need not develop a new framework or special regulations for nanotechnology because current fda regulations are adequate.115 however, there are other considerations, such as provisions that allow certain products to skip the pre-market testing process, that make some believe the fda’s regulations are inadequate.116 3. occupational safety and health administration osha regulations are in place to protect employees that handle dangerous materials.117 the general duty clause behind the regulations, imposes on an employer the duty to maintain “a place of employment . . . free from recognized hazards that are causing or are likely to cause death or se http://www.nanotechproject.org/process/assets/files/5979/07120nanotechnology_epatsca_pr. pdf. 109. id. 110. see brindell, supra note 11, at 75; see also 15 u.s.c. §§ 2601–29. 111. see 21 u.s.c. § 301–99 (2006). 112. see paradise et al., supra note 7, at 403. 113. id. 114. id. at 403-04. 115. id. at 404. 116. for example, under the federal food, drug, and cosmetic act, there is no premarket testing for cosmetics. wilson, supra note 48, at 707. 117. see generally 29 c.f.r. § 1910 (2010). 450 indiana health law review [vol. 8:2 rious physical harm to his employees.”118 because the hazard must be recognized to impose a duty on the employer, nanotechnology creates problems for osha regulations as the possible hazards have not yet been determined. thus, the regulations seem to imply that no safety requirement has to be met until concrete hazards are identified. specifically, osha regulates on a product-by-product basis, where each product requires different procedures and reporting requirements, and allows different levels of exposure to employees.119 nanotechnology is not listed as a category under “toxic and hazardous substances.”120 further, “recognized hazard” goes to the knowledge of the employer,121 or in the absence of actual knowledge, to the standard of knowledge in the industry.122 in the case of nanomaterials, a one-time assessment of risks will likely not be sufficient. risks are likely to change over time. for example, many remember that the harsh reality of asbestos did not become known until many years after it had been put to use and hailed as a breakthrough in technology.123 4. consumer product safety act the cpsa focuses on protecting consumers from unreasonable risks of injury associated with consumer products.124 under the cpsa, the consumer product safety commission (“the commission”) “may ban products that create an “unreasonable risk of injury” when “no feasible consumer product safety standard” can adequately address that risk.”125 “because the commission’s regulatory authority is generally limited to consumer products not specifically regulated by another statute, its authority would not extend to many nanotechnology applications, including foods, drugs, cosmetics, pesticides, and automobiles,”126 all of which are regulated under other statutes.127 thus, though the purpose of the cpsa focuses on increasing consumer safety where federal regulations are inadequate,128 the limiting language greatly stifles this purpose. 118. 29 u.s.c. § 654(a)(1) (2006); see also sarahan, supra note 14, at 194-96. 119. see generally 29 c.f.r. § 1910 (for example, subpart z of 29 c.f.r. § 1910 lists specific toxic and hazardous substances such as asbestos (29 c.f.r. § 1910.1001) and lead (29 c.f.r. § 1910.1025)). 120. see 29 c.f.r. § 1910, at subpart z. 121. see 29 c.f.r. § 1903.1 (2010). 122. see ethel alston, what is “recognized hazard” within the meaning of general duty clause of occupational safety and health act (29 u.s.c.a. § 654(a)(1))?, 50 a.l.r. fed 741 (1980). 123. wilson, supra note 48, at 710. 124. albert c. lin, size matters: regulating nanotechnology, 31 harv. envtl l. rev. 349, 369 (2007). 125. see id. at 369 (quoting 15 u.s.c. §§ 2057 (2006)). 126. id. 127. see, e.g., toxic substances control act, 15 u.s.c. §§ 2601-29 (2006); federal food, drug, and cosmetic act, 21 u.s.c. §§ 301–99 (2006). 128. see 15 u.s.c. § 2051 (2006). 2011] nanotechnology and voluntary regulatory programs 451 5. other sources there are other non-federal sources that may be capable of regulating nanomaterials; however, none of these are particularly suited to deal with the needs of nanotechnology. the international council on nanotechnology (“icon”) is working on gathering and compiling information on nanotechnology.129 icon is an international organization “whose mission is to develop and communicate information regarding potential environmental and health risks of nanotechnology . . . .”130 icon seeks to foster “risk reduction while maximizing [the] societal benefit[s]” of nanomaterials.131 this information gathering is useful, but icon lacks any actual authority for enforcement. thus, no companies are forced to release information to icon. in a similar manner to what is proposed in this note, the epa previously convened a voluntary industry program known as the nanoscale materials stewardship program (“nmsp”).132 the nmsp sought to encourage those in the nanotechnology industry to provide the agency, on a voluntary basis, with scientific information about risk management practices.133 the nmsp invited participating companies to voluntarily share existing data and discuss a program designed to develop new data for the long-term.134 for a voluntary program to enjoy a maximum amount of participation, incentives must be given. this note’s proposed voluntary program would incentivize the maximum amount of companies to participate and will seek to gather new information and encourage greater levels of research rather than merely accepting reports of existing data. b. why federal regulations for debate? the current debate around nanotechnology regulation centers on possible federal action, rather than state action. both avenues have costs and benefits, but the benefits of federal action for nanotechnology outweigh state benefits for long-term regulation. however, the benefits of state action suit short-term goals such as a voluntary regulatory program. the case 129. see generally int’l council on nanotechnology, rice university, http://www.icon.rice.edu (last visited oct. 26, 2010). 130. int’l council on nanotechnology, mission and strategy, rice university, http://icon.rice.edu/about.cfm?doc_id=4379#mission (last visited oct. 26, 2010). 131. id.; see also kristen kulinowski & matthew jaffe, the goodnanoguide: a novel approach for developing good practices for handling engineered nanomaterials in an occupational setting, 6 nanotechnology l. & bus. 37, 38-41 (2009) (detailing the creation of “the goodnanoguide,” an internet site where companies can share occupational practices for safe handling of nanomaterials). 132. nanoscale materials stewardship program, u.s. envtl. prot. agency, http://www.epa.gov/opptintr/nano/stewardship.html (last updated apr. 22, 2010). 133. see id. 134. see id. 452 indiana health law review [vol. 8:2 for government regulation rests on three assumptions: (1) public regulations are both democratic and fair because governments choose to openly respond to public concerns, and not private interests. (2) governments have the ability to correctly estimate the cost of externalities and then propose systems to compel firms to internalize these regulations. (3) the state is capable of enforcing regulations, and firms will tend to adhere to the law.135 thus, federal regulations are likely to be the primary mechanism for compelling companies to internalize costs that they would otherwise externalize. federal regulations alter a company’s cost calculus, forcing them to include externality costs when deciding on production outputs, budgets, etc. it is also easier for governmental agencies to assess risks over a large area of research and then gather information accordingly. the federal government not only has larger amounts of funding and resources than the states do, the federal government can also implement across-the-board policies, rather than having each state set its own individual policy. this allows for common accounting so all data may be effectively compiled. for instance, the national institute of occupational safety and health (“niosh”), a federal agency, has identified ten critical topic areas that need to be addressed with regard to knowledge gaps in nanotechnology research.136 the question that undoubtedly comes to mind, is why not regulate nanotechnology on a state-by-state basis instead of federally? the answer comes from examining the costs and benefits of using state regulations. imposing regulations on a state-by-state basis could hurt local state businesses if surrounding states have lesser regulations. harsher regulations equal higher costs, which put one state’s innovative companies at a relative disadvantage to another’s. in states that have greater regulations, companies would have to expend more resources to comply with the regulations and thus charge higher prices to make up for those costs. this would hurt one state’s competitive balance with surrounding states that have less stringent policies. 135. see aseem prakash & matthew potoski, collective action through voluntary environmental programs: a club theory perspective, 35 pol'y stud. j. 773, 775 (2007). 136. nat’l inst. of occupational safety and health educ. and info. division, nanotechnology: 10 critical topic areas, centers for disease control and prevention, http://www.cdc.gov/niosh/topics/nanotech/critical.html (last updated sep. 22, 2010) (the ten critical topic areas identified by niosh include fire and explosion safety, exposure assessment epidemiology and surveillance, and toxicity and internal dose). 2011] nanotechnology and voluntary regulatory programs 453 federal regulations make sense as a logical method of efficiently monitoring and controlling the nanotechnology industry, because nanotechnology is a technical field where there are relatively few experts. accordingly, concentrating these experts at one federal level rather than dispersing them among the states is more efficient. terry davies, a senior fellow at the think tank, resources for the future, noted that “a lot is changing at the federal level, but there are a lot of problems . . . . so, there’s no question that there’s a lot of room for states to take initiative . . . .”137 meanwhile, gaps in data “are forcing unprepared state and local governments to bear the brunt of regulating the new technology’s potentially hazardous risks . . . .”138 additionally, though discussion is focused at the federal level, “federal regulations charge a lot of key statutes to the states.”139 however, state programs are effective in other ways. states can focus on individual state concerns and priorities in research and regulation. in addition, state regulations are more accessible for change by consumers and companies while federal regulations tend to be more inelastic. some state and local entities have already decided to take nanotechnology into their own hands. surprisingly, it seems these initiatives have been successful. berkeley, california, and cambridge, massachusetts, both have local ordinances that address nanotechnology, the first of their kind.140 both require companies to report products that contain nanoparticles, and while berkeley’s reporting is mandatory, cambridge’s reporting is voluntary.141 berkeley’s first local nanotechnology ordinance was passed in december of 2006.142 the nanoparticle ordinance adds a nanoparticle health and safety disclosure requirement to already existing mandatory inventory and safety plans required from companies.143 worry has arisen in berkeley because the ordinance presumes high toxicity.144 thus, unless proven otherwise by the innovative company, the nanoparticle products will be deemed dangerous. additionally, in the future, there exists the problem of inconsistent requirements around the country if many conflicting local ordinances are passed. cambridge, massachusetts, has addressed the concern that strict regulations stifle innovation. cambridge was the first u.s. city to regulate re 137. see dolgin, supra note 26. 138. id. 139. id. (quoting maria powell, environmental scientist at the university of madison-wisconsin’s nanoscale science and engineering center). 140. see higgs, supra note 1. 141. id. 142. matthew heartney & john carlton, city of berkeley begins implementation of nanotechnology ordinance, 19 intell. prop. & tech. l. j. 18, 18 (2007). 143. see rick delvecchio, berkeley considering need for nano safety, s.f. chron., nov. 24, 2006, at a1. 144. id. 454 indiana health law review [vol. 8:2 combinant dna research and is now a leading biotech research center.145 thus, even if strict local regulations are passed, evidence suggests innovation will not necessarily be stifled. wisconsin is the only state that has a nanotechnology working group.146 the group is comprised of several wisconsin governmental agencies including the department of natural resources.147 the wisconsin legislature is contemplating a mandatory registry that would inventory the nanomaterials being made rather than putting restrictions on their use, and the state seems concerned with ensuring the registry does not stifle innovation.148 currently, the group is outlining nanotechnology benefit and risk data gaps and ways to proactively address them.149 likely, the regulatory registry will be similar to that of berkeley, california. not only are there pros and cons to the many different federal regulations that can be used to regulate nanotechnology, there are pros and cons between choosing the federal government or the states to do the regulating. for long-term efficiency, federal regulations are likely the best choice as federal regulations seek to find a cohesive solution for a large class of products. however, reaching a cohesive and effective federal solution will take time, and states could benefit immediately from state-specific regulation. thus, while the nanotechnology industry awaits federal regulations, a state voluntary program can be implemented. c. problems with existing regulations―short-term and long-term there are several problems with using existing federal mechanisms to regulate nanoparticle products. thus, to adequately regulate nanotechnology, a new federal scheme may need to be crafted. because federal regulations are already established, they do not allow room for flexibility. therefore, it must first be considered whether any of the existing regulations will work as they currently stand. as noted previously, the tsca would likely regulate nanomaterials as “new” materials.150 if nanocontaining technologies and products cannot be considered new, the general consensus is that they do not fit within any other categories in the tsca, and industry has often taken the position that this means they cannot be ef 145. see hiawatha bray, cambridge considers nanotech curbs: city may mimic berkeley bylaws, boston globe, jan. 26, 2007, at c1, available at 2007 wlnr 1584801. 146. see dolgin, supra note 26. see generally intergovernmental nanotechnology working group, university of wisconsin-madison nanoscale science and engineering center, http:/www.nsec.wisc.edu/ns--nugget.php?id=42 (last visited feb. 16, 2010). 147. see intergovernmental nanotechnology working group, supra note 146. 148. see dolgin, supra note 26. 149. id. 150. see supra part iii.a.1. 2011] nanotechnology and voluntary regulatory programs 455 fectively regulated under the tsca.151 many nanoparticles are synthesized from their macro-counterparts.152 accordingly, the inherent composition of nanoparticles is not new. rather, the only thing new about nanomaterials is their size. if fda regulations are utilized, it is likely that some products containing nanotechnology would be put on the market without extensive testing. for example, cosmetics are never subjected to pre-market testing by the fda.153 in addition, it is unlikely that the agency would require a showing of adequate testing by the innovative company if certain conditions are first met. many products that go through fda testing are not required to submit to extensive pre-market testing first.154 this is the case if the product is substantially similar to a product already on the market.155 this exception allows for more competition, better use of fda resources, and supposedly more innovation. however, because we do not know the hazards of nanomaterials, and because nanomaterials come in many sizes and levels of reactivity, it would not be safe to allow inadequately tested nanoparticle products onto the market without extensive pre-market approval. additionally, because many nanomaterials have macro-counterparts, the fda would unlikely submit those products to more rigorous testing, assuming they behave similarly. another concern with using the current fda regulations is whether nanomaterials actually act like any other product on the market. some have argued that there is no need for a product to go through testing when the only difference between it and a product already on the market is the use of nanotechnology.156 this assumes that the nano-product will perform the same as the existing product. in reality, it is often unknown whether using nanomaterials instead of the relevant macro-counterpart will create a different reaction. seemingly, the fear stems from the increased surface area to volume ratio, which while optimal for greater reactivity of nanomaterials, may come with unwanted side effects that have not yet been readily understood. the cpsa is limited to consumer products not specifically regulated by another statute.157 thus, its authority may not extend to many nanotechnology applications because they could, in theory, be regulated by other 151. jeffrey rudd, regulating the impacts of engineered nanoparticles under tsca: shifting authority from industry to government, 33 colum. j. envtl. l. 215, 225 (2008). 152. lynn bergeson, tsca and engineered nanoscale substances, nanotechnology l. & bus., march 2007, at 51, 53. 153. wilson, supra note 48, at 708. 154. see generally 21 u.s.c. § 301-99 (2006). 155. id. 156. see gregory mandel, nanotechnology governance, ala. l. rev. 1323, 1357 (2008). 157. see discussion, supra part iii.a.4. 456 indiana health law review [vol. 8:2 federal regulations.158 additionally, osha regulations are useful for employee safety, but do not attempt to protect the public once the product reaches the market.159 since existing federal regulations cannot adequately regulate nanomaterials, and are unlikely to work in the short-term, why not simply create a new set of regulations designed specifically for nanotechnology? the problem comes from the difficulties in the legislative process that would be involved in adopting such regulations. if a whole new set of regulations must be drafted, the nanotechnology industry could go without substantial regulation for too long, as the legislative process may take a long time to develop any substantial regulations.160 it is equally unfeasible to assume innovative companies will stop producing until regulations are set. the perceived benefits of nanotechnology are too high. while it is clear that a definite timeframe has been pulled off the table, researchers fear that eliminating the timeframe altogether may allow for the effort to drag on indefinitely.161 in fact, it appears that no one is certain when a timeframe will be released or how long the decision to implement a timeframe will take to come into effect. a lack of timeframe is detrimental to consumer perceptions. consumers are likely to believe that the trouble with finding an adequate way to regulate nanotechnology reflects nanotechnology’s level of danger. in addition, in the short-term, the lack of regulations allows innovative companies to produce without being required to meet stringent safety and health requirements. clearly, consumers are adversely affected from the lack of regulation. if the many short-term effects of utilizing existing regulations are not enough, there are also long-term effects of both utilizing these existing federal regulations and failing to decide quickly on adequate regulations. existing regulations do not regulate nanotechnology per se, but rather, they only regulate products containing nanotechnology.162 thus, it is likely that some form of regulation beyond the existing regulations will eventually be needed. the best option is to make a long-term regulatory decision as quickly as possible. substantial oversight in the long-term may be practically impossible because there are so few experts in the individual fields of nanotechnology and researchers are often the only ones qualified to oversee a particular re 158. see discussion, supra part iii.a. 159. see 29 u.s.c. §§ 651–78 (2006). 160. rollins, supra note 26, at 231. 161. epa advisers decide against timeline for nanotech regulations, inside the epa, dec. 2, 2005, at section 48, available at 2005 wlnr 19334000. 162. as discussed above, the tsca would regulate nanotechnology as a “new chemical,” rather than as a separate category. see discussion, supra part iii.a.1. 2011] nanotechnology and voluntary regulatory programs 457 search area.163 in contrast, another solution is possible: voluntary programs can act product by product, or industry by industry, to reassure consumers of the precautions taken by nanotechnology companies. this allows federal programs to take the time needed to perfect the regulation decision and then eventually take over the regulatory burden. if consumers are heavily risk averse and there are no adequate regulations, nanotechnology progress could be brought to a standstill. using a single, existing federal regulation, will be inadequate. thus, the best decision for the nanotechnology industry is for an entirely new set of nano-specific regulations to be crafted federally. nevertheless, because of the time commitment required to set these new regulations, something must be done in the interim. iv. voluntary regulatory programs a. proposal for state level voluntary regulatory program a state level voluntary regulatory program could ease concerns over nanotechnology in the short-run. this proposed voluntary program would allow industry to regulate itself, with minimal oversight until adequate federal regulations are chosen.164 then, once one is decided upon, the proper federal regulations can take over. oversight can be performed not only by the government, but also by private companies and industry groups that coordinate to “articulate standards and create safeguards.”165 when determining regulations, “[i]t is important to achieve an appropriate balance [between varying interests] so that oversight does not stifle innovation or impose unnecessary costs or burdens [on the innovative company].”166 the nanotechnology specific goals for oversight are: “transparency in development, opportunities for public input, accountability to diverse stakeholders, [the] ability to safeguard human and environmental health, and [the] ability to foster innovation.”167 depending on the specific interest group and its individual concerns regarding nanotechnology, each group's rank of these goals may vary drastically. for instance, the public will likely be more in 163. for example, to oversee the prosecution of patents, the u.s. patent and trademark office (“uspto”) employs 6,292 patent examiners. these examiners review the over 460,000 patents filed each year. each patent concerns a specialized area of research with which many laymen are unfamiliar. likewise, nanotechnology regulation would require experts to ensure the regulations are met. employing a substantial number of experts, as the uspto does, will be difficult for nanotechnology. see generally patent production model, u.s. patent trademark office, http://www.uspto.gov/patents/stats/patent_pend_ model.jsp (last updated may 5, 2010). 164. see, e.g., int’l council on nanotechnology, supra note 129; nanoscale materials stewardship program, supra note 132. the voluntary program for nanotechnology takes these concepts further by adding incentives to companies for participation. 165. see paradise et al., supra note 7, at 408. 166. id. at 413. 167. id. at 415. 458 indiana health law review [vol. 8:2 terested in health and safety, while innovative companies will be concerned with fostering innovation and accountability to stockholders, whilst the government will be concerned with transparency and pubic input. a state level voluntary program could effectively work as a “band aid” temporarily relieving the problem until a more sufficient, sophisticated solution is discovered. in order for this to occur, each state would need to set standards for participation or negotiate these standards with the innovative companies inside each state. a cohesive state agency or board would be required to oversee the project. the necessary standards may vary with the "state of the industry" in each particular state, but universally required standards would include mandatory reporting of possible hazards and research conducted, as well as health and safety research minimums. each regulation’s level of strictness will depend on to what extent the particular state wants to promote nanotechnology within its borders, and how concerned the state is with being at the forefront of innovation.168 stricter regulations may momentarily stifle innovation, but would also create greater consumer appreciation for those companies that have met the standards. more lenient standards would allow a greater number of products to be released onto the market, yet would also fail to assure consumers of the products' safety. once an innovative company complies with the regulations of its state, or meets the standards, the given product should be awarded a special symbol on the label and on the product’s website. for occupational safety concerns, a notation could be placed on the company website/employment page, and this special notation would advertise the innovative company’s devotion to safety.169 the recognition would be good for consumers, potential employees, and federal governmental agencies. as for consumers, the recognition would alert them to the company’s standards of excellence and dedication to safety. hopefully, consumer support would then encourage consumption of products containing nanotechnology, which would in turn transfer back to the innovative company in the form of increased profits. potential employees may also be more likely to accept potentially risky employment when they know that the innovative company is concerned with their safety. this would likely attract more qualified employ 168. see generally snyder, supra note 30. a voluntary regulatory program would be a good fit for a state like indiana that houses many universities and companies currently involved in nanotechnology research. indiana operations such as altairnano and makuta have a dominant position in nanotechnology manufacturing. in indiana the core driver for research remains at the university level with schools including purdue university, university of notre dame, and valparaiso university. accordingly, the regulations set for indiana would likely be strict, mirroring the state’s interest in being a leader of the “nanotechnology revolution.” 169. see, e.g., u.s. envtl. prot. agency & u.s. dep’t of energy, energy star, http://www.energystar.gov (last visited oct. 27, 2010). the energy star logo on household appliances denotes devotion to energy efficiency. 2011] nanotechnology and voluntary regulatory programs 459 ees, which would translate to greater productivity, and further increases in profit and innovation for the innovative company. finally, the voluntary regulatory program can be used as a tool to gather information the federal government as long-term regulations are being crafted.170 the program would show what the innovative companies are willing and able to do, what standards appeal to the public at large, and what the emerging health and safety concerns regarding nanotechnology are. although complying with voluntary regulations may at first be costly to the innovative firm, the projected benefits may likely outweigh the costs.171 indeed, each benefit gained by potential employees, consumers, and the government, should relate back to the innovative company who incurs the cost of compliance. b. existing voluntary programs in other industries the existence of successful voluntary programs outside the nanotechnology industry can provide a framework for nanotechnology regulation going forward. these programs demonstrate how a voluntary program could work in the nanotechnology industry. in the past, voluntary programs have been used to reduce environmental concerns.172 voluntary environmental programs (“veps”) “seek to induce firms to produce positive environmental externalities beyond what existing government regulations require.”173 “environmental voluntary agreements [(“vas”)] are collaborative arrangements between firms and regulators in which firms voluntarily commit to actions that improve the natural environment.”174 in vas, “the regulator encourages and/or supervises” the actions of the firm.175 in the case of vas, the regulator is the epa, and in return for firms participating in the program, the epa publicizes the firms with outstanding pollution prevention achievement.176 as vas have proven to be effective, they can supplement, and sometimes even replace, command-and-control regulation.177 command-and-control regulation is what most people think of when governmental regulation is mentioned. the government sets standards, and 170. the motivation for information gathering in the voluntary program is much like that of the wisconsin working group that is attempting to gather information on nanotechnology. see intergovernmental nanotechnology working group, supra note 141. 171. see generally bray, supra note 145 (highlighting the fact that regulation of recombinant dna technology in cambridge, massachusetts did not stifle innovation). 172. see generally prakash & potoski, supra note 135. 173. id. 174. id.; see also magali a. delmas & ann k. terlaak, a framework for analyzing environmental voluntary agreements, 43 cal. mgmt rev. 44, 44 (2001). 175. id. 176. see, e.g., state and local transportation resources: voluntary programs, u.s. envtl prot. agency, http://www.epa.gov/otaq/stateresources/voluntaryprograms.htm (last updated oct. 15, 2008). 177. see delmas & terlaak, supra note 174, at 44. 460 indiana health law review [vol. 8:2 there is no bargaining or leniency with regard to those standards for any firm.178 in fact, the fdca, tsca and cpsa are all examples of commandand-control regulation.179 participation is mandatory if a firm wishes to be in the market.180 there are two types of vas: “negotiated agreements and public voluntary programs.”181 for negotiated agreements, “regulatory agencies and firms negotiate the targets of environmental performance that firms will have to reach,” however these targets are not usually legally binding on the firms themselves.182 examples of negotiated agreements include the german va on global warming prevention,183 and project xl.184 in both of these programs, firms commit to a higher environmental performance level than what is required under the mandatory standards and regulations.185 for example, the energy star program is considered a negotiated agreement.186 energy star logos are placed on any product that meets or exceeds performance criteria regarding energy efficiency.187 the energy star logo appeals to customers who care about the environment, as well as those who are interested in saving money through a valuable tax credit program.188 another example of a negotiated agreement can be seen in the epa’s design for the environment (“dfe”).189 dfe partners the epa with “industry, research institutions, and environmental groups to develop technological solutions to specific environmental challenges.”190 this information is then disseminated among businesses in hopes that the practices will be utilized by others.191 178. see, e.g., 21 u.s.c. § 360 (2006). 179. 21 u.s.c. § 301-99 (2006); 15 u.s.c. §§ 2601-29 (2006); 15 u.s.c.a §§ 20512089 (2006). 180. see generally 21 u.s.c. § 301-99; 15 u.s.c. §§ 2601-29; 15 u.s.c.a. §§ 2051-89. 181. see delmas & terlaak, supra note 174, at 46. 182. id. at 46-47. 183. see generally stephan ramesohl & kora kristof, the declaration of german industry on global warming prevention – a dynamic analysis of current performance and future prospects for development, 9 j. cleaner prod. 437 (2001). 184. see generally project xl, u.s. envtl. prot. agency, http://www.epa.gov/ projctxl/ (last updated sept. 30, 2010). 185. see, e.g., what is project xl?, u.s. envtl. prot. agency, http://www.epa.gov/projectxl/file2.htm (last updated sept. 30, 2010); ramesohl & kristof, supra note 183, at 438. 186. see u.s. envtl. prot. agency & u.s. dep’t of energy, supra note 169. 187. see u.s. envtl. prot. agency & u.s. dep’t of energy, about energy star, energy star, http://www.energystar.gov/index.cfm?c=about.ab_index (last visited oct. 27, 2010). 188. see u.s. envtl. prot. agency & u.s. dep’t of energy, federal tax credits for energy efficiency, energy star, http://www.energystar.gov/index.cfm?c=tax_ credits.tx_index (last visited oct. 28, 2010). 189. see design for the environment, home, u.s. envtl. prot. agency, http://www.epa.gov/dfe (last updated oct. 28, 2010). 190. see delmas & terlaak, supra note 174, at 50; design for the environment, supra note 183. 191. see delmas & terlaak, supra note 174, at 50. 2011] nanotechnology and voluntary regulatory programs 461 public voluntary programs are set up in a way where regulators establish the framework and basic requirements for participation.192 companies in each industry do not get a say in the regulation standards as they do in negotiated agreements.193 the epa’s voluntary children’s chemical evaluation program (“vccep”) is an example of a va that includes some of the qualities inherent in this note’s proposed program.194 the vccep was designed to “give citizens information on the effects of chemicals to enable them to make wise choices in the home and marketplace.”195 the focus of the vceep is the safety of children with regard to those chemicals. public voluntary programs generally co-exist with current regulations, while those existing regulations remain unchanged.196 the public voluntary programs are not intended for radical changes because the voluntary program must still operate within the bounds of the established federal regulations. accordingly, public voluntary programs ask slightly more of companies, usually in the form of increased reporting to the regulator or an even greater reduction in harm to the environment than federal regulations require. however, in the field of nanotechnology, radical changes must be made to regulate the new science instead of just requiring firms to report more under existing regulations. the fda has a program for voluntary labeling of raw fruits, vegetables, and fish.197 the company that seeks to produce and sell these items must provide nutrition labeling for at least 90 percent of the raw agricultural commodities listed in the 20 most consumed raw fruits, vegetables, and fish that they sell.198 the label must provide certain data as required by the fda and must be presented in an appropriate manner.199 compliance with code is required for placement of the label on the raw fruit, vegetable, or fish.200 seemingly, this regulation was put in place to assure consumers that each company uses safe handling techniques and processes for raw foods. however, the requirements of 21 c.f.r. section 101.43 are not strict and do not provide substantial benefits for the producer itself, and as a result, the effects are minimal. thus, a simple labeling standard is unlikely to be adequate for nanotechnology. 192. id. at 47. 193. id. at 46-47. 194. see generally voluntary children’s chemical evaluation program (vccep), u.s. envtl. prot. agency, http://www.epa.gov/oppt/vccep/ (last updated aug. 31, 2010). 195. id. 196. delmas & terlaak, supra note 174, at 47. 197. see 21 c.f.r. §101.43 (2010). 198. see 21 c.f.r. § 101.43(a) (2010); see also 21 c.f.r. § 101.44 (2010) (listing the 20 most consumed raw fruits, vegetables, and fish). 199. see 21 c.f.r. § 101.45 (2010). 200. the placement on the label is codified, but whether to label at all is voluntary. see 21 c.f.r. §101.43. 462 indiana health law review [vol. 8:2 wisconsin has proposed a voluntary program for bgh-free milk labeling.201 the proposed bill is voluntary, “but a closer read of the labeling legislation reveals that it establishes an extensive regulatory network of mandatory wholesale product labeling and tracking for wisconsin products only.”202 at the time, wisconsin representative eugene hahn argued that wisconsin producers would suffer because of the compliance, and that the voluntary program would eventually force dairy plants out of the state, taking jobs along with them.203 representative hahn believed the outcome of this bill, would not foster healthy practices in wisconsin, but force affected companies to relocate to other states that did not “require” the extensive labeling.204 this adverse effect for nanotechnology must be carefully avoided. voluntary regulations must be set at such a level as to encourage innovation and participation in the program at the same time. if requirements are set too high and companies stop producing, the benefits of nanotechnology will be lost. though not specific to nanotechnology, a final example of a voluntary regulatory program can be seen in the fdca’s program that requests registration of potentially hazardous cosmetic products.205 in addition to being voluntary, the program does not require any sort of toxicity information.206 for nanotechnology, the toxicity information is the most important aspect of the proposed voluntary program. however, there are advantages to the fdca program. the program allows the fda to gather information on potentially hazardous products that enter the market.207 any sort of information gathering can be used to develop a better future regulatory scheme, and it would be useful for a nanotechnology company to participate in a program like that of the fdca. nonetheless, currently, there are no voluntary programs thorough enough to gather adequate information on nanotechnology to design a federal regulation. incentives would also need to be large enough that nanotechnology companies would spend their own resources to participate. c. advantages of voluntary program a voluntary regulatory program for nanotechnology has the potential 201. see generally eugene hahn, editorial, bgh labeling hurts wisconsin, capital times, jan. 5, 1994, at 9a. 202. id. 203. id. 204. id. 205. 21 c.f.r. §§ 710, -20 (2010). see generally voluntary cosmetic registration program (vcrp), u.s. food and drug administration, http://www.fda.gov/ cosmetics/guidancecomplianceregulatoryinformation/voluntarycosmeticsregistrationprogramv crp/default.htm (last updated aug. 6, 2010). 206. id. 207. id. 2011] nanotechnology and voluntary regulatory programs 463 to realize advantages for innovation, public perception, and health and safety. additionally, nanotechnology producers will participate in a voluntary program because of the increased profits and reputational benefits. 1. innovation a voluntary regulatory program will aid innovation because it will reward compliance rather than punishing the failure to comply. the reward for compliance will be designed so that the innovative company recoups the financial cost expended for compliance with increased sales and customer loyalty. in the environmental context, veps are believed capable of encouraging proactive industry, reducing transaction costs, and accelerating the achievement of environmental targets, due in part to less legal action and conflict.208 2. public perceptions voluntary regulatory programs would positively affect the public perception of the nanotechnology industry. the proposed regulatory program can be used by innovative companies as a strategic tool to “reduce their regulatory burden, develop new . . . competencies ahead of competition, and communicate their . . . responsible behavior to customers.”209 voluntary programs allow for win-win situations where “[t]he regulator achieves the desired result with decreased enforcement costs, while the regulated community is provided with more flexibility in meeting societal goals—thus eliminating economic inefficiencies.”210 when social goals are met, the public benefits from not only increased safety but also less apprehension regarding a new technology. federal regulations, as opposed to state regulations, are the better option to ease consumer apprehension because federal regulations provide a nationally cohesive approach to arising problems. federal regulations are unlikely to be implemented until far into the future. consequently, voluntary programs are important for the immediate future. additionally, vas can serve to anticipate and shape future federal regulations. innovative companies will already be familiar with some of the regulations, which allows for a smooth transition to the long-term federal regulations. those regulatory schemes that appeal to the public can be implemented into long-term regulations. awarding labels to participating innovative companies allows for public recognition and confidence in the industry. for example, most consum 208. see dinah koehler, the effectiveness of voluntary environmental programs – a policy at a crossroads?, 35 the pol’y stud. j. 689, 691 (2007). 209. see delmas & terlaak, supra note 174, at 44. 210. dorothy daley, voluntary approaches to environmental problems: exploring the rise of nontraditional public policy, 35 the pol’y stud. j. 165, 165 (2007). 464 indiana health law review [vol. 8:2 ers recognize the energy star label as an appliance that is good for the environment and that can lower energy costs.211 thus, with a voluntary regulation and noticeable labels, consumers may feel as though their concerns, in both production and products, are being considered. a lesser fear of the technology, initially and in the future, can be gained by using a voluntary regulatory scheme.212 of course, as consumers buy more nano-containing products, innovation by the participating companies is also likely to increase. 3. health and safety additionally, voluntary programs can be viewed as testing grounds for new practices that may become the industry standard.213 this would surely be the case if findings during research such as health and safety risks and preventative practices are distributed to the entire industry. consumers that value improved environmental or safety performances incentivize innovative companies to continue innovation. thus, a company can differentiate itself through participation in a voluntary program and a higher price can be set to capture additional market share.214 with higher prices and profits come higher levels of innovation as the innovative company has more resources to put into new projects. most importantly, a voluntary regulatory program implemented before federal regulations are chosen will have a positive impact on safety. voluntary programs reward the “good guy” for making the industry safer, rather than punishing the wrongdoer like most regulations.215 this is an especially important feature considering we do not yet know what or who the “bad guy” is in nanotechnology. safety can also be increased through a voluntary regulatory program by attracting more qualified employees to a potentially hazardous industry such as nanotechnology. participation in the voluntary program may attract potential employees to the innovative company when employees know extra caution is being taken. finally, as firms agree to higher standards of safety, they are likely to incur less liability in the future. as regulations are met, it is clear that overall safe practices will be used by complying companies. 211. see generally u.s. envtl. prot. agency & u.s. dep’t of energy, supra note 169. 212. see, e.g., voluntary children’s chemical evaluation program (vccep), supra note 194. 213. see epa launches effort to boost enrollment in voluntary programs, clean air report, oct. 18, 2007, available at 2007 wlnr 20378986. 214. see delmas & terlaak, supra note 174, at 52. 215. wendy wagner, using competition-based regulation to bridge the toxics data gap, 83 ind. l.j. 629, 652-64 (2008). 2011] nanotechnology and voluntary regulatory programs 465 4. incentives for firm participation in general, firms will only choose to participate in the voluntary program if they anticipate a net gain following compliance. therefore, when the benefits outweigh the cost of compliance, a firm will participate. in contrast, when the cost of compliance is not outweighed by the benefits of such compliance, the firm will not participate. if a voluntary program is created to address an industry-wide regulatory threat, but only some firms participate, the resulting information gained will still benefit the entire industry. this may incentivize a firm to free-ride on those participating; meaning companies may enjoy benefits as a direct result of contributions from others. thus, it is important that firms determine whether “a va offers a unique opportunity to gain a competitive advantage or the possibility of turning into a costly enterprise.”216 d. disadvantages of voluntary program the disadvantages of voluntary programs must be weighed against the benefits. at least in the short-term, the benefits of a voluntary program outweigh the disadvantages, warranting its use. a voluntary program may be costly to innovative companies.217 to reap the benefits of the voluntary program, expenditures have to be made. assuming a higher level of business will be achieved after compliance, the original outlay of resources is not a detriment. however, when the voluntary program is first initiated, there is no guarantee to the innovative company that satisfactory benefits will follow. in addition, for a voluntary regulatory program to work, a regulatory agency is still needed to oversee the program and assess the rewards. this may take away manpower from attempting to settle the long debate over concrete federal regulation. however, as proposed, this agency will be at the state level. those employees also have to be compensated somehow. further, if voluntary regulations are promulgated at the state level, as proposed, resources will not be taken away from federal agencies. state regulation incurs other disadvantages, however. differences in regulation requirements across states could prove to be confusing to consumers.218 even if each state has a different level of compliance that must be met to gain the advantage, consumers are likely to value each level of compliance equally. thus, companies in a state that has lower levels of compliance will have to expend fewer resources to gain the same degree of benefits. to overcome this problem, more cohesive standards could be set. however, 216. see delmas & terlaak, supra note 174. 217. id. 218. see hahn, supra note 201. 466 indiana health law review [vol. 8:2 the remedy simply brings back the problems that federal regulation would create. thus, some amount of inefficiency is going to result when attempting to address the hazards of nanotechnology. for some level of cohesiveness between the state programs, a common label or symbol that is awarded to complying companies could be developed. as developing a symbol should not take a long period, one state may be able to take the reins, develop the symbol, and give it to other states to use. it is important that the symbol is the same across state lines so that consumers are easily familiarized with nano-containing products and so that those products can travel in both inter and intra state commerce. that way the innovative company will benefit even when its products are transported across state lines. negotiation and administrative costs that arise from forming the voluntary agreement may be too high for some companies. however, these costs can be reduced by the state agency setting the requirements, instead of costly negotiations occurring. however, this leads back to the original problem that those with the most knowledge of the industry, work in the industry and not for government.219 it may also pose a problem regarding the ability of the regulator to maintain a consistent way of defining evaluating, and creating new voluntary programs.220 generally, the state of the industry as it is (unregulated) benefits the manufacturing community because of the reduced amount of research expenditure that is necessary. thus, pressure from industry professionals for greater regulatory oversight does not exist, or is weak at best.221 further disadvantages mirror those of self-regulation. disclosure to government always carries the risk that competitors will discover proprietary information about a company through information sharing.222 this is due to the government's incentive to create social benefits by sharing information with all. 223 additionally, the “production and distribution of information is costly.”224 free-rider problems may arise if a firm feels it can shirk responsibilities and still gain benefits from increased knowledge or public perception based on the participation of other firms.225 in chamber of commerce v. u.s. department of labor, a governmental agency’s implementation of a voluntary regulatory program that had yet to undergo a formal rulemaking process had violated statutory and constitu 219. see epa launches effort, supra note 213. 220. id. 221. wagner, supra note 215, at 656. 222. see generally mary lyndon, secrecy and access in an innovation intensive economy: reordering information privileges in environmental, health and safety law, 78 univ. col. l. rev. 465 (2007). 223. see generally alan devlin, the misunderstood function of disclosure in patent law, 23 harv. j.l. & tech. 401, 402 (2010). 224. see rollins, supra note 26, at 232. 225. see zycher et al., supra note 59. 2011] nanotechnology and voluntary regulatory programs 467 tional protections, and ultimately, the challenged program claimed to be voluntary but had provisions that imposed mandatory sanctions.226 a truly voluntary program is acceptable if it comes in to effect absent a formalized process; however, once penalties are written in, constitutional protections may be crossed.227 implementing a voluntary program for nanotechnology will undoubtedly provide both advantages and disadvantages. however, in the case of nanotechnology, where the future of the regulations and the industry is generally uncertain, the advantages of increased knowledge and production will likely to outweigh the disadvantages. further, the disadvantages for the proposed program will not accumulate since the program is not a permanent solution, but a temporary fix. e. how a state level program would look the state level voluntary regulatory program for nanotechnology would require innovative companies to report the products being researched and products that contain nanomaterials, to a designated state agency. in addition, the type of nanomaterial used, and the known risks of that nanomaterial will need to be disclosed. for the company to receive the benefits of the program, it will also have to meet a certain research minimum, along with reporting what is being done internally to reduce the potential risks of nanomaterials. these reports will be required annually along with a showing that competent research is being done to assess potential risks. minimum requirements would ideally be set by the federal government, and any further requirements may be determined on a state-by-state basis. however, the entire program may be state run in order to streamline the process if necessary. additionally, the specific research levels and safe practices are determined based on the type of industry that is producing or researching nanotechnology. for example, a university would likely have to meet a greater research minimum than a small independent company in order to be deemed compliant with the regulations. universities will also have to focus efforts on safe handling practices rather than consumer safety, as they are not producing products for the market. large producers will also have to meet a larger research minimum, and be expected to share those results among one another, because the larger companies are likely to have the manpower and resources available to meet stricter regulations as compared to small and start-up companies. as a result, larger companies will be able to provide the greatest benefit to consumers and the government. 226. see chamber of commerce of the u.s. v. u.s. dep’t of labor, 174 f.3d 206 (d.c. cir. 1999). 227. id. 468 indiana health law review [vol. 8:2 research results (only regarding health and safety, not specific innovations) would be anonymous when released to the state agency. innovative companies would then be able to build off one another’s experience to better equip the nanotechnology industry to deal with health and safety issues. sharing information also ensures that multiple research projects that come to the same safety conclusion do not have to overlap. available resources can then be used more productively. once the given level of compliance is met, the company, university, etc. would be rewarded. the reward would be two-fold. first, it would allow the complier to label the products it produces with a label that denotes its dedication to the research and safety of nanotechnology.228 the notation would also be available on the product, or company, website. the hope is that this notation will put consumers on notice that the products they use contain nanomaterials and that the company producing such nanomaterials is concerned with overall health and safety issues. if the innovative company admits to the presence of nanotechnology, and shows that substantial research is being done, consumer apprehensions are likely to be eased with the disclosure. thus, the company can continue producing and innovating without fear of unnecessary liability, or loss of sales. second, the notation could also be placed on the company’s website or hiring page.229 this notation would alert potential employees of that company’s efforts to protect employees from the potentially hazardous effects of nanotechnology. to get the voluntary program up and running, each state in conjunction with local industry would be advised of a six-step framework.230 this would help to determine the levels of compliance necessary in the given state and across industries in order for the program to attain the intended benefits. the framework proposed by environmental defense and the dupont corporation is a good starting point and includes: 1) developing a description of the nanomaterial based on existing information; 2) developing profiles based on “inherent hazards and associated exposures,” and discussing how such profiles are likely to change in the lifetime of the nanomaterial; 3) evaluating available information so as to “identify and characterize the nature, magnitude, and probability of risks”; 4) evaluating risk management options and recommending an appropriate course of action; 5) engaging key stakeholders to determine whether to continue development, or whether to continue already utilized risk management techniques; and 6) regularly updating and re-executing risk evaluations.”231 228. see, e.g., project xl, supra note 178; u.s. envtl. prot. agency & u.s. dep’t of energy, supra note 169. 229. see kristen kulinowski & matthew jaffe, supra note 131, at 38-41 (detailing the creation of “the goodnanoguide” which seeks to encourage good occupational health and safety practices). 230. linkov et al., supra note 92, at 208. 231. id. 2011] nanotechnology and voluntary regulatory programs 469 this process should be repeated and compliance standards updated every few years until mandatory federal regulations are finalized. ideally, this process would not only increase safety in conducting nanotechnology research, but also push for a new, permanent federal regulatory scheme for nanotechnology. v. conclusion a voluntary regulatory scheme for the nanotechnology industry is the best option among the many proposed but imperfect solutions to bring about immediate results. a voluntary scheme will incentivize research into the potential hazards of nanomaterials, increase public perception of the industry, and stimulate innovation. while voluntary regulations are unlikely to provide sufficient long-term protection for the nanotechnology industry the benefits of implementing a state run voluntary program in the short run are great. as long-term federal regulation has not been chosen, and the process of implementing federal regulations takes time, voluntary regulations can fill the gap. without sufficient oversight of nanotechnology, the safety of factory workers and consumers buying products could be at risk. it is not a certainty that nanotechnology will have the same long-term effects as asbestos; however, the risk should not be allowed to materialize. the current uncertainty with the lack of oversight could preclude consumers from ever having confidence in nanoparticle products. consumer apprehensions will ultimately stifle innovation of what is a breakthrough technology. when health and safety are at issue, action must be taken as soon as possible. ultimately, in the case of nanotechnology, a voluntary program that noticeably awards superior participation can ease the current state of nanotechnology, and at the same time, leave federal regulations to contemplate the future. microsoft word 1-masthead vol. viii.doc autism insurance reform: a comparison of state initiatives melissa stuart∗ people are always looking for the single magic bullet that will totally change everything. there is no magic bullet. temple grandin i. introduction ............................................................................... 498 ii. background ................................................................................ 500 a. autism spectrum disorders ..................................................... 500 1. diagnosis, symptoms, and prevalence .............................. 500 2. treatments ......................................................................... 502 3. the cost of autism ............................................................ 504 b. state-sponsored services ......................................................... 505 1. early intervention services and the school system........... 505 2. medicaid waivers and other state-sponsored treatment programs.......................................................... 506 c. health insurance and autism ................................................... 507 1. enrollment ......................................................................... 508 2. coverage ........................................................................... 509 a. asds as non-medical conditions ................................ 509 b. asd treatments ........................................................... 510 (i) treatment is experimental .................................. 510 (ii) treatment is not medically necessary ................ 511 (iii) treatment is habilitative, custodial, or maintenance ....................................................... 511 (iv) treatment is considered “educational” ............. 512 (v) no qualified in-network providers ..................... 512 3. consumer protection tools ............................................... 513 d. autism insurance reform ......................................................... 514 1. current state autism insurance mandates common ∗ j.d. candidate, 2011, indiana university school of law – indianapolis; b.s., 2003, virginia tech; m.s., 2008, indiana university purdue university indianapolis. 498 indiana health law review [vol. 8:2 provisions and definitions ................................................ 515 a. covered persons ......................................................... 515 b. covered services ......................................................... 517 c. covered providers ....................................................... 518 d. treatment plans .......................................................... 519 e. maximum benefit amounts .......................................... 521 f. prohibiting limits on the number of visits ................... 522 g. prohibiting termination or refusal to renew a policy . 523 h. types of insurance plans affected ............................... 523 2. autism treatment acceleration act of 2009 (“ataa”) .... 526 e. controversies and asd insurance reform .............................. 527 1. who should pay for asd services? .................................. 527 2. financial impact of asd insurance reform ..................... 529 iii. analysis ....................................................................................... 531 a. asd insurance mandates ........................................................ 531 1. covered persons................................................................ 532 a. age .............................................................................. 532 b. diagnosis .................................................................... 532 2. covered services ............................................................... 533 3. covered providers ............................................................. 534 4. treatment plans ................................................................ 535 5. maximum benefit amounts ................................................ 536 6. types of policies covered ................................................. 536 iv. conclusion .................................................................................. 537 i. introduction imagine the frustration of having a child with a disability, knowing there is a potentially life-changing treatment available but being unable to provide it―because it costs over $70,000 a year and is not covered by insurance. to what lengths would you go to provide this treatment for your child, even if it does not turn out to be the magic bullet you were hoping for? would you take out a second mortgage on your house? would you exhaust your savings or cash in your retirement accounts? for many parents of children with autism spectrum disorders (“asds”), this is their reality. asds describe a range of complex neurological disorders characterized by marked impairments in communication and social relatedness and the presence of restricted repetitive or stereotypic patterns of behavior, interests or activities.1 asds include autistic disorder, asperger’s syndrome, 1. am. psychiatric ass’n, pervasive developmental disorders, in diagnostic and statistical manual of mental disorders 69 (4th ed., text rev. 2000). 2011] autism insurance reform: a comparison of state initiatives 499 and pervasive developmental disorder, not otherwise specified (“pddnos”). each person with asd displays an individualized pattern of behaviors or impairments, making a large number of symptom presentations possible. this extreme variability in symptoms and severity makes treatment difficult and costly. the autism society of america (“asa”) estimates that asds cost the united states $60 billion annually.2 however, the cost of lifelong care for each person with autism, according to asa, can be reduced by two-thirds with early diagnosis and intervention.3 due to dwindling state budgets and the rising incidence of asds, many states are not able to adequately address the asd populations’ needs under current state-sponsored programs like medicaid waivers, early intervention, and special education programs.4 further, many individuals with asd have difficulty obtaining adequate health insurance, meaning that interventions offered through private providers place an enormous financial burden on families.5 advocates believe the most secure means of accessing treatment for individuals with asd is through legislatively mandated health insurance coverage.6 as of january 2011, twenty-three states have enacted autism insurance mandates.7 all but three states have introduced or are proposing 2. this figure includes both direct (i.e., health care, costs to care for individuals with autism) and indirect costs (parent/caregiver missed work, etc.) associated with asds, it does not include funds spent on research. facts and statistics, autism soc’y of am., http://www.autism-society.org/site/ pageserver?pagename=about_whatis_factsstats (last visited jan. 9, 2011). 3. press release, autism soc’y of am., asa publishes model legislation for autism insurance coverage (feb. 16, 2009), available at http://www.autismsociety.org/site/docserver/02-16-2009_asa_publishes_model_legislation_for_autism_ in.pdf?docid=12061. 4. autism speaks, arguments in support of private insurance coverage of autism-related services 7 (2009), http://www.autismvotes.org/atf/cf/%7b2a179b7396e2-44c3-8816-1b1c0be5334b%7d/arguments%20for%20private%20insurance %20coverage.pdf [hereinafter autism speaks, arguments]. 5. id. at 4. 6. see id. 7. arizona (ariz. rev. stat. § 20-826.04 (lexisnexis 2010)); colorado (colo. rev. stat. § 10-16-104(1.4) (2010)); connecticut (conn. gen. stat. § 38a-514b (2010)), florida (fla. stat. § 627.6686 (2010)), illinois (215 ill. comp. stat. ann. 5/356z.14 (lexisnexis 2011)); indiana (ind. code § 27-8-14.2 (2009)); iowa (iowa code ann. § 514c.26 (west 2010)); kansas (kan. stat. ann. § 75-6524 (2010)); kentucky (ky. rev. stat. ann. § 304.17a-142 (west 2010)); louisiana (la. rev. stat. ann. § 22:1050 (2009)); maine (me. rev. stat. ann. 24-a, § 2766 (2010)); massachusetts (mass. gen. laws ann. 32a, § 25 (west 2010)); missouri (mo. ann. stat. § 376.1224 (west 2010)); montana (mont. code ann. § 33-22-515 (2009)); nevada (nev. rev. stat. ann. § 689b.0335 (lexisnexis 2010)); new hampshire (n.h. rev. stat. ann. § 417-e:2 (lexisnexis 2010)); new jersey (n.j. stat. ann. § 17b:27-46.1ii (west 2009)); new mexico (n.m. stat. ann. § 59a-23-11 (lexisnexis 2009)); pennsylvania (40 pa. stat. ann. § 764h (west 2009)); south carolina (s.c. code ann. § 38-71-280 (2008)); texas (tex. ins. code ann. § 1355.015 (west 2009)); vermont (vt. stat. ann. 8, § 4088i (2010)); and wisconsin (wis. stat. § 632.895(12m) (2009)). 500 indiana health law review [vol. 8:2 autism insurance reform laws.8 furthermore, there is a proposed federal insurance mandate included in the autism treatment acceleration act of 2009 (“ataa”), currently referred to the senate health, education, and labor committee, that would require states to mandate coverage for medically necessary therapy for individuals with asd.9 the goal of this note is to provide a summary of issues leading to the enactment of autism insurance reform, compare current state initiatives, and identify potential concerns in current legislative language. the first section provides a background on asds, including treatments, costs, and the current system for providing services. the next section provides a background on the health insurance industry’s treatment of asds that led to the development of autism insurance reform. it includes information on riskshielding techniques used by the industry and available consumer protection tools. the third section presents current state and federal autism insurance initiatives and specifically examines common provisions and controversies surrounding autism insurance mandates. the final section identifies problems with the current state and federal autism insurance reform initiatives and offers suggestions for addressing those issues. ii. background a. autism spectrum disorders 1. diagnosis, symptoms, and prevalence autism is a complex neurological disorder characterized by marked impairments in communication and social relatedness and the presence of restricted repetitive or stereotypic patterns of behavior, interests or activities.10 autism is on the lower end of a spectrum of pervasive developmental disorders (“pdds”) with asperger’s syndrome at the high end and pervasive developmental disorder, not otherwise specified (“pdd-nos”) typically somewhere in the middle.11 these three separate diagnoses are often referred to as autism spectrum disorders (“asds”).12 asds are di 8. as of january 2011, oklahoma, utah, and wyoming are currently not pursuing autism insurance reform. see 2011 state initiative agenda: current status of state autism insurance reform bills, autism speaks (jan. 7, 2011), http://www.autismvotes.org/atf/cf/ %7b2a179b73-96e2-44c3-8816-1b1c0be5334b%7d/state%20map%20-%201.7.11.pdf. 9. autism treatment acceleration act of 2009 (ataa), s. 819, 111th cong. § 12 (2009). 10. am. psychiatric ass’n, supra note 1, at 70-71. 11. the spectrum refers to severity and characteristics of symptoms. 299.00 autistic disorder, am. psychiatric ass’n. (2010), http://www.dsm5.org/proposedrevisions/pages/ proposedrevision.aspx?rid=94#. 12. id. autism spectrum disorders is a colloquial term used to describe the three most common pdds, however, the term will likely be adopted as the medical term in the next 2011] autism insurance reform: a comparison of state initiatives 501 agnosed by physicians, psychiatrists, or clinical psychologists through observational methods and interviews with the child’s caregivers;13 there are currently no approved medical tests to accurately confirm a diagnosis.14 despite their conceptualization as points on the same spectrum, there are important differences among the three asd diagnoses. asperger's syndrome differs from autism because with asperger’s syndrome there is no delay in language or cognitive development.15 because people with asperger’s syndrome have marked impairments with social interactions, many children are not diagnosed until they reach grade school age when social problems become more apparent.16 children with autism, on the other hand, must have symptoms present prior to age three but can be identified as early as two years old.17 pdd-nos requires that there be impairment in reciprocal social interaction with an impairment in communication skills or the presence of stereotyped behaviors, interests, or activities, but some criteria of typical autism may be lacking, such as a late onset of symptoms or failure to meet all the three symptom clusters.18 each person with asd presents with an individualized pattern of behaviors or impairments making a large number of symptom presentations possible. the severity of these disorders varies along a continuum, with some individuals having more profound problems in one key diagnostic area than others. asds are associated with the full range of cognitive abilities, from profoundly mentally impaired to exceptionally bright.19 in addition to the diagnostic symptoms, individuals with asd often have underlying co-morbid health issues.20 seizures affect as many as twenty-five percent of individuals with asd.21 additionally, many individuals experience anxiety, depression, sensory disturbance, hyperactivity, attention-deficit, gastro-intestinal problems, ear infections, allergies, and edition of the dsm. the other pdds, rett’s disorder and childhood disintegrative disorder (“cdd”), are less common and not currently considered part of the autism spectrum. however, dsm-5 proposes to phase out rett’s disorder altogether as a pdd and include cdd as an asd. 13. see, e.g., catherine lord et al., autism diagnostic interview-revised: a revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders, 24(5) j. autism & dev. disorders 659, 660 (1994), available at http://infantlab.fiu.edu/articles/ lord,rutter,lecouteur_1994%20jadd.pdf. 14. despite the reliance on observation and interview, the use of magnetic resonance imaging (“mri”) to diagnose autism is possible in the near future. see a major step in diagnosing autism through mri, autism soc’y of am. (oct. 21, 2010), http://www.autismsociety.org/site/news2 ?page=newsarticle&id=16562&news_iv_ctrl=1882. 15. am. psychiatric ass’n, supra note 1, at 80. 16. id. at 81. 17. id. at 71. 18. id. at 84. 19. id. at 69, 71, 81. 20. id. at 72 (including chromosomal abnormalities, congenital infections, and structural abnormalities of the central nervous system). 21. id. 502 indiana health law review [vol. 8:2 sleep disorders.22 due to the wide range of additional medical problems associated with asd, access to medical care is important. asds affect every race, ethnicity, and socioeconomic status. however, asds increasingly affect males compared to females.23 in 2000, it was estimated that between two to and twenty children out of every 10,000 had autism.24 in 2006, the centers for disease control estimated that one out of every one hundred children has an asd.25 the prevalence of asds is increasing dramatically in every state,26 each lacking an adequate system to support their needs.27 2. treatments there is no cure for autism.28 however, with intervention, many individuals with asd can make significant improvements in decreasing symptoms and living independently.29 there are several recommended interventions for asds including behavioral, speech, occupational, and physical therapy, as well as medications to address symptoms associated with asds.30 a commonly prescribed treatment protocol, and the most controversial in the fight for insurance coverage, is applied behavior analysis (“aba”). aba is a toolbox of behavioral modification principles based on theories of learning and operant conditioning.31 the goal is to reinforce appropriate behaviors like communication, socialization, and self-help skills, and decrease problem behaviors like stereotyped or repetitive movements, self 22. id. 23. id. at 73 (noting rates of autism are four to five times higher in males than in females). 24. id. 25. autism and developmental disabilities monitoring network (addmn), prevalence of autism spectrum disorders, centers for disease control (2006), http://www.cdc.gov/ mmwr/preview/mmwrhtml/ss5810a1.htm. a discussion relating to the dramatic increase in the number of children with asds in the past decade is outside the scope of this note. however, many factors likely contribute to the increase including increased physician awareness, an expansion of the diagnostic criteria in 1994 to include individuals with asperger’s syndrome, and the development of more readily available screening measures. 26. see id. 27. autism speaks, arguments, supra note 4, at 4. 28. nat’l inst. of child health and human dev. (“nichd”), nih pub no. 055592, autism overview 7 (2005), available at http://www.nichd.nih.gov/publications/pubs/ upload/ autism_overview_2005.pdf [hereinafter, nih pub no. 05-5592]. 29. s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(3) (finding that, “research strongly indicates that early detection, diagnosis, and treatment of children with autism spectrum disorders result in significant improvements in functioning . . .”). 30. nih pub no. 05-5592, supra note 28, at 10. 31. id. at 8. 2011] autism insurance reform: a comparison of state initiatives 503 injury, and aggression.32 researchers have successfully posited several models of aba interventions.33 while the core behavior modification principles remain the same, the intensity, frequency, duration, setting, and therapist characteristics may change based on the intervention model used. researchers are still working to find the right combination of factors that produce the best results. however, all agree that early intensive intervention is key to compounding the positive effects of any aba therapy model.34 with early intervention, children with autism have shown improvements in iq, language, academic performance, adaptive behaviors, and social skills.35 one intervention model with demonstrated success involves intensive treatment requiring thirty to forty hours of therapy a week for several years.36 half the children treated with these intensive behavioral intervention models can overcome their autistic characteristics such that they are indistinguishable from their peers.37 recently, researchers at the center for autism and related disorders found that forty-three percent of children with autism participating in their study who received an aba-based program consisting of at least twenty-five hours per week of treatment no longer displayed clinical symptoms of autism and demonstrated improvements in functioning.38 because aba therapy involves a great deal of time, it is quite expensive and most medical insurance policies do not cover it.39 wealthy parents may pay thousands of dollars a year40 and less fortunate children likely go 32. id. 33. see id. 34. see s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(3); autism speaks, arguments, supra note 4, at 9. 35. see, e.g., study reveals children recover from autism with intensive three-year behavioral therapy, medical news today (nov. 13, 2010, 1:00 pm pst), http://www.medicalnewstoday.com/articles/207798.php; s. 127, gen. assemb., reg. sess. (vt. 2010) §§ 1(3)(a), (b), (c). 36. autism speaks, arguments, supra note 4, at 9. 37. id. 38. study reveals children recover from autism with intensive three-year behavioral therapy, supra note 35. 39. see justine redman, mom wins first for autism insurance, cnn (apr. 1, 2008), http://www.cnn.com/2008/health/conditions/04/01/autism.insurance/index.html?iref=alls earch; abt. associates, inc., autism spectrum disorders mandated benefits review panel report: evidence submitted concerning pennsylvania hb 1150, at 7 (june 18, 2008), available at http://www.autismvotes.org/atf/cf/%7b2a179b73-96e2-44c3-88161b1c0be5334b%7d/hc4autismpanelreport061808.pdf [hereinafter pennsylvania hb 1150]. 40. see redman, supra note 39 (estimating $70,000 $80,000 per year); sarah mueller, health care law may help families with autism costs, dallas morning news (may 11, 2010, 9:02 am cdt), http://www.dallasnews.com/sharedcontent/dws/news/city/ collin/plano/stories/051110 dnmetautism.41d0d68.html (reporting that parent pays $5,000 per month for asd services); pennsylvania hb 1150, supra note 39, at 13 (quoting a parent who spent approximately $600,000 in asd services in the past twelve years). 504 indiana health law review [vol. 8:2 without therapy.41 without early intensive aba therapy, children with asd are likely to place a large financial strain on the state through placements in costly special education programs or institutionalization in state hospitals.42 3. the cost of autism the societal cost of autism is estimated at $35 billion to care for all individuals with autism over their lifetime.43 this cost is driven by both direct and indirect costs.44 direct costs are incurred, like any child, through expenses associated with routine medical and dental care.45 however, children with asd use health care services more frequently than typically developing children and are responsible for higher health care costs.46 indirect costs associated with asd include lost productivity by parents who may reduce the hours they work outside the home or forego outside employment entirely to care for their child.47 indirect costs also include productivity lost for adults with asd who are unable to work.48 these costs have enormous ramifications for society’s tax base as children with asd transition into adulthood. if a child with an asd is not properly treated, the societal cost for that one child over his or her lifetime could be as high as $3.2 million.49 the costs associated with caring for an individual with asd have led many states to sponsor treatment programs through public schools and medicaid waiver programs. 41. see s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(4) (reporting on a survey which found that approximately fourteen percent of children with an asd had foregone care, thirty-eight percent of families of children with an asd had financial problems caused by their child’s health care, and thirty-five percent of families noted needing additional income to cover medical expenses). 42. see, e.g., s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(7), (8); see also pennsylvania hb 1150, supra note 39, at 11, 25. 43. michael l. ganz, the lifetime distribution of the incremental societal costs of autism, 161 archives of pediatrics & adolescent med. 343, 343 (2007). 44. id. at 344 (explaining that direct costs include the values of goods and services used, whereas indirect costs include value of lost productivity both from the adults with autism unable to work and from parents who reduce work hours in order to care for their child). 45. id. 46. see id. at 348; pennsylvania hb 1150, supra note 39, at 20. 47. see s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(4) (noting a national survey which found that fifty-seven percent of families of children with an asd had a family member reduce or stop employment because of the child’s condition, and twenty-seven percent of families reported spending ten or more hours per week providing or coordinating care for their child). 48. ganz, supra note 43, at 344. 49. id. at 343; s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(1). 2011] autism insurance reform: a comparison of state initiatives 505 b. state-sponsored services traditionally, states provide services to individuals with asd through various agencies and state-funded programs. these services are expensive. for example, in 2009, indiana’s bureau of developmental disabilities services (“bdds”), the state agency responsible for administering services, spent approximately $536 million on services for individuals with asds and other developmental disabilities.50 consequently, the increased prevalence of asd coupled with dwindling state budgets has created a system that cannot possibly support the burgeoning need. 1. early intervention services and the school system under the 2004 reauthorization of the individuals with disabilities education act (“idea”), early intervention and special education programs must provide services and treatments to children with asds.51 early intervention programs typically include children from birth to three years old who have a developmental delay.52 in 2009, indiana served approximately 10,000 children at an estimated cost of $34 million in its early intervention program.53 unfortunately, because services stop at age three, many children with autism who are unable to be diagnosed until approximately eighteen months old cannot take advantage of these types of programs for very long, if at all. with respect to the school setting, idea only requires services when the child’s exceptionalities affect his or her ability to receive an education.54 therefore, higher functioning children or children with asperger’s syndrome, for example, would likely be excluded from receiving treatment through the school. additionally, problems associated with treating individuals with asd are too numerous to be dealt with through the public school system alone.55 according to a 2005 government accounting of 50. peter a. bisbecos, director, january monthly financial review, div. disability & rehabilitative serv., indiana family & social serv. admin. 2 (feb. 26, 2009), http://www.in.gov/fssa/files/2.09_ddrs_mfr.pdf. see also s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(2) (reporting that vermont spent an estimated $57 million on services for individuals with asds in 2007). 51. 34 c.f.r. § 300.101 (2006) (part b, education services); 34 c.f.r. § 300.226 (2006) (part c, early intervention covering children birth to three years old); see also nih pub no. 05-5592, supra note 28, at 9; see, e.g., bisbecos, supra note 50, at 36 (stating that first steps is indiana’s early intervention program). 52. 34 c.f.r. § 300.226; see, e.g., bisbecos, supra note 50, at 36. 53. bisbecos, supra note 50 at 37, 39. it is impossible to tell how much of that total is attributed to individuals with asds as data are not available by diagnosis for this age group. 54. 34 c.f.r. § 300.101; see also nih pub no. 05-5592, supra note 28, at 9. 55. see victoria c. bunce & j.p. wieske, the growing trend toward mandating autism coverage, 152 issues & answers at 1 (mar. 2009), available at http://www.cahi.org/cahi_contents /resources/pdf/n152autismtrend.pdf (noting only three 506 indiana health law review [vol. 8:2 fice report, the average expenditure per pupil for educating a child with autism was more than $18,000 in the 1999-2000 school year, almost three times the average per pupil expenditure of educating a child who does not receive any special education services.56 similarly, vermont reported in 2009 spending an average of $42,500 per child annually for students with asd, totaling approximately $765,000 per child over eighteen years of education.57 however, early behavioral intervention could result in a savings of “near or above $200,000 per child over the course of the child’s educational career.”58 2. medicaid waivers and other state-sponsored treatment programs medicaid waivers are home and community-based services (“hcbs”) waivers provided by many states to persons with developmental disabilities or long-term illnesses.59 services provided under a medicaid waiver help a person live at home or within their community instead of in an institution.60 several states, including indiana, have autism or developmental disability-specific medicaid waivers.61 in 2009, indiana’s medicaid spending for waiver services totaled approximately $288 million.62 however, only a certain number of people can be served by a waiver leading to a backlog of individuals waiting for a spot to open up.63 due to percent of children with autism have their needs met under idea); b.d. v. debuono, 130 f. supp. 2d 401, 401 (s.d.n.y. 2001) (noting concerns of parents of children with autism who are claiming public schools unlawfully implemented policies to prevent, discourage, or limit the use of aba). see also stacy k. dymond, christie l. gilson, & steve p. myran, services for children with autism spectrum disorders, 18 j. disability pol’y stud. 133, 134, 143 (2007), available at http://dps.sagepub.com/content/18/3/133.full.pdf+html. 56. u.s. gov’t accountability office, gao-05-220, special education: children with autism, at 2 (2005), available at http://www.gao.gov/new.items /d05220.pdf. 57. s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(8). 58. s. 127, gen. assemb., reg. sess. (vt. 2010) § 1(6) (citing two studies in its findings in favor of coverage for autism services). see also gregory s. chasson, gerald e. harris, & wendy j. neely, cost comparison of early intensive behavioral intervention and special education for children with autism, 16 j. child fam. stud. 401, 401 (2007) (finding that the state of texas would save a total of $2.09 billion with early intensive behavioral intervention). 59. ind. governor’s council for people with disabilities, indiana medicaid home and community-based services waiver programs: a guide for consumers 6 (4th ed. 2007), available at http://www.in.gov/fssa/files/consumerwaiverguidew200703 .pdf. 60. id. they are called waivers because the programs typically waive or reduce the income requirements of traditional medicaid programs. 61. see, e.g., id. at 7. 62. bisbecos, supra note 50, at 5. 63. marci wheeler, indiana’s home and community based waivers, 12(2) the reporter 3, 5 (2007), available at http://www.iidc.indiana.edu/index.php?pageid=555. see also bisbecos, supra note 50, at 12 (noting that in 2009, indiana had 18,855 individuals on waiting lists for all medicaid waiver programs). 2011] autism insurance reform: a comparison of state initiatives 507 tremendous waiting lists, it is unlikely an individual will get a medicaid waiver during the period immediately following diagnosis when intervention would be most effective. aside from the limited number of individuals the waivers are able to assist,64 the services provided to those who qualify are often deficient in quality of personnel and standards of care. medicaid suffers from low reimbursement rates, which makes it difficult for many organizations to retain qualified service providers.65 moreover, services accessed through the medicaid system are often inadequate to meet the specific needs of a child with autism.66 for example, a pennsylvania panel reviewing the need for autism insurance reform noted that, “pennsylvania's medicaid waiver program is fragmented, does not cover all of those in need, and has inadequate payment schedules for at least some providers and specific services.”67 therefore, while medicaid waiver programs offer much needed assistance, they often help too few and are inundated with problems.68 to summarize, asds are complicated disorders with a dramatically increasing prevalence rate and expensive treatments that cannot be supported by the current state-funded systems. faced with such a dire situation, many states explore alternative methods of providing services to its citizenry – in this case, health insurance. c. health insurance and autism individuals with asd may seek insurance coverage through a variety of means. children with asd are likely to enroll as dependents on their parent’s health insurance plan or under state-sponsored health insurance programs.69 however, as adults, individuals with asd would be able to continue coverage under their parent’s health insurance plan only if they are 64. see, e.g., bisbecos, supra note 50, at 7 (noting that a total of 11,109 individuals receiving waiver services with only 7,093 receiving comprehensive waiver services). 65. autism speaks, arguments, supra note 4, at 8. 66. see dymond, gilson, & myran, supra note 55, at 134 (“frequently, individuals who are responsible for providing services to children with asd . . . lack specific training in asd. although services may be available . . . [services] may not result in desired outcomes if the provider is ineffective in delivering them.”). 67. pennsylvania hb 1150, supra note 39, at 5. 68. see, e.g., hummel v. ohio dep’t of job & family serv., 844 n.e.2d 360, 361 (6th cir. 2005) (finding that the state medicaid program denied aba treatment because it was not the lowest cost alternative); parents league for effective autism serv. v. jones-kelley, 565 f. supp. 2d 905, 910 (s.d. ohio 2008) (finding that a denial of aba therapy following an amendment to the state’s medicaid plan was to avoid having to pay for services); rosie d. v. romney, 410 f. supp. 2d 18, 52 (d. mass. 2006) (finding that the state failed to meet the medicaid act’s mandate to provide services with reasonable promptness and also failed to provide supports at adequate levels of duration and intensity). 69. see, e.g., what is schip, schip information ctr., http://www.schip-info.org/ (last visited jan. 9, 2011). 508 indiana health law review [vol. 8:2 considered a legal and disabled dependent.70 if the individual does not qualify for medicaid or receive benefits through an employer, the only option available is for individual coverage. because individuals with asd use a disproportionate amount of health care services, insurance companies have historically attempted to minimize the risk associated with providing coverage for this group.71 there are two main ways insurers exclude people with asds from coverage: (1) through enrollment practices; and (2) through limitations and exclusions in the terms of coverage.72 1. enrollment typically, when a person applies for individual health insurance coverage, the company goes through an underwriting process to evaluate the risk posed by insuring that individual.73 some people are considered too big a risk to be permitted to enroll, or may enroll only under pre-existing condition exclusions designed to protect the group from expensive health conditions present at the time of enrollment.74 pre-existing condition exclusions allow enrollment while imposing total exclusions for pre-existing conditions or, in some cases, waiting periods for coverage of pre-existing conditions.75 for individuals with an asd, this means that they may have more difficulty obtaining coverage, would only be covered for medical services not associated with their diagnosis, or if subject to a waiting period, would have to wait a specific period of time before receiving coverage.76 with the recent health care reform, insurers may be prohibited from exclud 70. see, e.g., indiana state personnel dept., form 53388(10-07), verification of dependent disability status (2007), available at http://www.in.gov/icpr/webfile/ formsdiv/53388.pdf. criteria generally include the disability to have occurred before age 19, affirmation that the dependent is unable to engage in gainful employment because of his or her disability, and annual documentation from a physician. 71. see, e.g., pervasive developmental disorders, clinical policy bulletin 0648 (aetna), http://www.aetna.com/cpb/medical/data/600_699/0648.html (last visited dec. 18, 2009); medical policy, beh.00004 (anthem) http://www.anthem.com/medicalpolicies/ policies/mp_pw_a050279.htm (last visited dec. 18, 2009) (stating policies limiting what is covered for asds). 72. see symposium, legal solutions in health reform: insurance discrimination on the basis of health status, 37 j.l. med. & ethics 103, 106 (2009) [hereinafter symposium]. 73. id. at 105. 74. id. 75. id. at 107. 76. press release, illinois dep’t. of ins., insurance coverage for autism, at 3 (rev. oct. 2009), available at http://www.insurance.illinois.gov/pressrelease/pr08/ autismfactsheet.pdf [hereinafter press release, ill. doi] (noting that illinois law allows insurance companies to exclude coverage for pre-existing conditions, including autism, for up to two years). see also pennsylvania hb 1150, supra note 39, at 7 (noting a study that found all of the forty-six insurers surveyed to exclude autism). 2011] autism insurance reform: a comparison of state initiatives 509 ing children with pre-existing conditions from coverage.77 individuals with autism who are permitted to enroll may be charged higher premiums.78 underwriting permits the adjustment of premiums to reflect the anticipated level of financial risk.79 individuals whose characteristics (i.e., health status and personal characteristics that predict health status and insurance use) pose higher financial risks would pay a higher premium. sometimes charging a significantly higher premium is enough to render coverage unaffordable, thus, constructively barring someone from enrolling. fortunately, as discussed below, autism insurance mandates include a provision prohibiting insurance companies from charging a higher premium solely because the individual has an asd.80 however, laws aimed at disabling a company’s ability to control financial risk at the point of enrollment can lead to an increased use of risk-shielding tools in the policy’s terms of coverage.81 2. coverage post-enrollment risk-shielding limits the amount, duration, or scope of coverage. there are several ways that insurance companies have avoided covering services for individuals with asd including: treating asds as non-medical conditions; finding treatments to be experimental, educational, not medically necessary, or habilitative in nature; or denying claims because there is no qualified provider. a. asds as non-medical conditions as a threshold matter, insurance companies are historically unsure how to deal with autism as a diagnosis. some classify it as mental illness, which would place it under mental health coverage.82 others classify it as a chronic illness, placing treatments in the long-term care category.83 the designation is important in determining whether asds are covered at all, as some health plans do not offer coverage for mental health or long-term disability.84 some states, like indiana, have resolved this issue by specifically defining autism as a neurological disorder that falls under medical insurance coverage.85 this means that an insurer in indiana cannot classify asds as 77. see mueller, supra note 40. 78. symposium, supra note 72, at 106. 79. id. at 105. 80. see infra part ii.d.1.h. 81. see symposium, supra note 72, at 106. 82. see, e.g., wis. stat. § 632.895(12m)(a)(5) (2009); see also bunce & wieske, supra note 55, at 1. 83. bunce & wieske, supra note 55, at 1. 84. pervasive developmental disorders, supra note 71. 85. ind. code § 27-8-14.2-3 (2009) (“pervasive developmental disorder means a neu510 indiana health law review [vol. 8:2 mental health disorders or use mental health exclusions to limit coverage.86 even when asd’s designation as a medical condition is not in question, there are other ways insurance companies attempt to exclude coverage. one way is to deny coverage for asds based on the person’s diagnosis.87 for example, in illinois, an insurance carrier denied coverage for speech therapy because the plan excluded therapies for conditions of developmental delay, learning or educational problems, and non-restorative medical conditions even though speech therapy would be available to treat other conditions.88 b. asd treatments another way insurance companies attempt to avoid paying claims for asd treatment is by focusing on the treatment or the provider. insurance companies have an arsenal of tools for denying coverage for services to treat asd symptoms, many of which are discussed below.89 (i) treatment is experimental to promote the use of effective, scientifically valid treatments, insurers may limit coverage to evidence-based treatments. because of the extreme variability in symptom presentation for individuals with asds, efforts to identify treatments that meet the health insurance industry’s standards for evidence-based treatments are difficult for researchers to achieve. insurance companies argue that autism is an individually based disorder, and so there is often no clear standard of care.90 therefore, health insurance carriers that provide coverage for autism may classify certain therapies as “experimental and investigational,” thereby excluding those rological condition.”); colo. rev. stat. § 10-16-104(1.4)(iii) (2010) (stating that asd is a neurobiological disorder); conn. gen. stat. § 38a-514b(b) (2010) (classifying asd as an “illness”). but see n.h. rev. stat. ann. § 417-e:2 (lexisnexis 2010) (defining asds as biologically-based mental illness). 86. michelle trivedi, indiana's health insurance mandate for autism spectrum disorders (asds) and pervasive developmental disorders (pdd's), indiana inst. on disability and community, http://www.iidc.indiana.edu/index.php? pageid=547 (last visited jan. 10, 2011). 87. pennsylvania hb 1150, supra note 39 (noting a study that found all forty-six commercial employment-based health insurance policies surveyed excluded autism as a medical condition). 88. wheeler v. aetna life ins. co., no. 01 c 6064, 2003 u.s. dist. lexis 12742, at *40 (n.d. ill. jul. 21, 2003). see also, morgenthal v. american telephone & telegraph co., inc., 97 civ. 6443, 1999 u.s. dist. lexis 4294, at *5 (s.d.n.y. apr. 5, 1999) (stating that insurer refused coverage for autism treatments because it was considered a developmental disorder). 89. see mchenry v. pacificsource health plans, cv-08-562-st, 2010 u.s. dist lexis 321, at *323 (d. ore. jan. 5, 2010); redman, supra note 39. 90. bunce & wieske, supra note 55, at 2. 2011] autism insurance reform: a comparison of state initiatives 511 therapies from coverage.91 aba therapy, in particular, is often considered experimental despite its proven effectiveness.92 (ii) treatment is not medically necessary another way insurance companies attempt to avoid coverage for asd is to determine that the therapies are not medically necessary.93 plans differ in the precise language but generally, medically necessary services are those that the plan’s administrator considers appropriate for the treatment and diagnosis of a covered illness.94 insurers may deny coverage for therapies based on a lack of medical necessity even if a treating physician prescribes the service.95 (iii) treatment is habilitative, custodial, or maintenance sometimes services available for medical conditions in the short-term are excluded for use as long-term therapy for individuals with asd.96 one justification for excluding asd treatments otherwise covered for other conditions is that insurers do not believe such therapies have a “reasonable expectation of achieving sustainable, measurable improvement in a reasonable and predictable period of time.”97 when restoration of previous functioning is required, it automatically eliminates the “potential for covering treatments whose medical purpose is to help a patient attain, maintain, or avert the loss of functioning.”98 91. see bussey v. corning life serv., inc., no. 97cv8875, 2000 u.s. dist. lexis 658, at *6 (n.d. ill. 2000). 92. see carey v. conn. gen. life ins. co., civ. no. 02-3642(jne/jsm), 2004 u.s. dist. lexis 3823, at *2 (d. minn. mar. 8, 2004); mchenry, 2010 u.s. dist. lexis 321, at *3; see also pervasive developmental disorders, supra note 71; medical policy, supra note 71. 93. minutes from the tex. dep’t ins., at 7 (dec. 5, 2008), available at http://www.tdi.state.tx.us /hmo/documents/120508asdminutes.pdf [hereinafter minutes]; press release, ill. doi, supra note 76, at 3. 94. bails v. blue cross/blue shield of ill., 438 f. supp. 2d 914, 918 (n.d. ill. 2006); hummel v. ohio dep’t of job and family serv., 844 n.e.2d 360, 363 (6th cir. 2005). generally medically necessary treatments are identified in a person’s policy. 95. bussey, 2000 u.s. dist. lexis 658, at *3. 96. see, e.g., pervasive developmental disorders, supra note 71, at (p). 97. pennsylvania hb 1150, supra note 71, at 7. see also bails, 438 f. supp. 2d at 920; in re micheletti v. state health benefits comm., 913 a.2d 842, 845-46 (n.j. super. ct. app. div. 2007); kan. stat. ann. § 75-6524(a)(7)(b) (allowing an insurer to deny a claim if the covered individual has reached the maximum medical improvement). but see, n.m. stat. ann. § 59a-23-11(b)(3) (lexisnexis 2009) (prohibiting treatment from being denied on the basis that the “services are habilitative or rehabilitative in nature”). 98. symposium, supra note 75, at 107. 512 indiana health law review [vol. 8:2 (iv) treatment is considered “educational” another way insurers deny coverage for some asd treatments is by categorizing the treatments as educational.99 states are required to provide certain services, including aba and other therapies, if it will help the individual receive an education.100 therefore, insurance companies have historically not covered services that are available through the school. speech and aba therapy are typical targets for exclusion as educational interventions.101 for example, aetna’s description of aba therapy stresses the role of education and identifies it specifically as an excluded educational intervention.102 (v) no qualified in-network providers another way insurance companies are able to deny coverage for aba in particular is to deny the treatment because it is not administered by a qualified or credentialed provider.103 the bulk of intensive aba therapy may be administered by an unlicensed, uncertified provider (typically a college student, recent college graduate, or parent), with a certified provider overseeing the treatment.104 while there is national certification for both the supervisor and the direct care provider,105 several states do not recognize those certifications for obtaining a state license.106 99. see pervasive developmental disorders, supra note 71; medical policy, supra note 71. 100. see supra section ii b 1. 101. see pervasive developmental disorders, supra note 71; medical policy, supra note 71. see also bunce & wieske, supra note 55, at 2. 102. pervasive developmental disorders, supra note 71. 103. carey v. conn. gen. life ins. co., civ. no. 02-3642 (jne/jsm), 2004 u.s. dist. lexis 3823, at *2 (d. minn. mar. 8, 2004) (denying aba therapy because there was no "license, credentialing or medical supervision of the program.”); louisiana dep’t of ins., act 648 autism insurance tip sheet, at 2 (jan. 20, 2009), available at www.laddc.org/main/wp-content/uploads/2009/01/act-648-parent-tips-12009.pdf [hereinafter la act 648 tip sheet] (noting, “without being credentialed by the insurance plan the provider of aba treatments will not be able to seek reimbursement.”). 104. trivedi, supra note 86. 105. see becoming certified: standards and applications for examination, behavior analyst certification board (“bacb”), http://bacb.com/index.php?page=53 (last visited jan. 1, 2011) [hereinafter becoming certified]. there are currently seventy-three certified aba practitioners in indiana. certificant registry search results [search: indiana], bacb, http://www.bacb.com/index.php? page=100155 (last visited jan. 8, 2011). 106. see, e.g., ind. dep’t ins., bull. 136, insurance coverage for pervasive developmental disorders, at 2 (mar. 30, 2006), available at http://www.in.gov/idoi/files/bulletin 136.pdf [hereinafter ind. bull. 136]; la act 648 tip sheet, supra note 103, at 2. 2011] autism insurance reform: a comparison of state initiatives 513 3. consumer protection tools insurers draft the insurance contract in such a way that they retain broad discretion over whether to approve or deny coverage.107 when an insurer denies coverage, the company is required to let the insured know the reason for the denial.108 to challenge a denied claim, the consumer can appeal through the company’s internal grievance process.109 indiana’s department of insurance as said that the internal review, when related to asd services, must be done by a physician with expertise in asds.110 because the burden of proof lies with the consumer to show why the claim is a covered service, fighting a denial can be difficult and frustrating.111 if the consumer is still not satisfied after exhausting the company’s internal grievance process, he or she may file a complaint with their state agency that regulates insurance or seek a remedy through the court system.112 in addition to licensing health insurers, states also regulate the insurers’ finances, market conduct, policy forms, rules regarding access to coverage, required benefits, premiums, renewability, provider network arrangements, and consumer complaints.113 state insurance regulators can serve as intermediaries to resolve specific conflicts.114 in addition, state insurance regulating agencies can facilitate an external review by a panel of independent medical experts.115 however, the external review process may only be available for specific denials.116 state insurance regulators may create and enforce rules or develop guidelines for how insurance companies should interpret mandates.117 in 2006, nearly five years after the autism insurance mandate went into effect, the indiana department of insurance issued a bulletin clarifying how insur 107. symposium, supra note 72, at 107. 108. ind. bull. 136, supra note 106, at 3. 109. trivedi, supra note 86. 110. ind. bull. 136, supra note 106, at 1. see also, 215 ill. comp. stat. ann. 5/356z.14(g) (lexisnexis 2011) (requiring review by a physician with expertise in autism). 111. symposium, supra note 72, at 107. see also, redman, supra note 39. 112. see 40 pa. stat. ann. § 764h(k)(2) (west 2009); bussey, 2000 u.s. dist. lexis 658, at *13; trivedi, supra note 86. 113. gary claxton & janet lundy, how private health coverage works: a primer: 2008 update 8 (the kaiser family foundation 2008), available at http://www.kff.org/insurance/upload /7766.pdf. 114. ind. bull. 136, supra note 106, at 3; colo. rev. stat. § 10-16-104(1.4)(h) (2010); la act 648 tip sheet, supra note 103, at 2. 115. see 40 pa. stat. ann. § 764h(k)(1) (west 2009) (noting that a covered individual is entitled to an expedited independent external review administered by the pennsylvania insurance department); claxton & lundy, supra note 113, at 13. 116. minutes, supra note 93; mchenry v. pacificsource health plans, cv-08-562-st, 2010 u.s. dist lexis 321, at *7 (d. or. 2010) (noting the insured was not entitled to an external independent review because the claim was denied based on reasons other than medical necessity or experimental treatment). 117. claxton & lundy, supra note 113, at 10. 514 indiana health law review [vol. 8:2 ance companies were to handle issues regarding the mandate.118 however, there can still be problems in relying on state agencies to deal with consumer complaints. for example, in california, a consumer advocacy group is suing the department of managed health care for allegedly permitting health insurers to deny coverage for aba.119 while judicial review is available for state insurance regulator determinations, the high deference afforded to agency decisions makes it difficult to challenge in court.120 lawsuits may also be brought under contract or tort law theories, such as fraud or bad faith, or under special state insurance laws.121 typically, courts interpret insurance exclusions narrowly and coverage broadly.122 however, while courts may offer protection for consumers, the time, money, and resources needed to pursue litigation against an insurance company is not something many people can afford.123 to summarize, insurance companies have denied coverage to individuals with asd under many different plan exclusions. the current process to challenge denials, while moderately successful, is time consuming and may be costly. one solution to the inadequate state-sponsored services and the insurance industry’s treatment of autism gaining popular support is autism insurance reform. d. autism insurance reform mandates are laws that require state-licensed health insuring organizations to offer or include coverage for certain benefits or services.124 one of the latest state legislative trends is to enact a stand-alone autism insurance mandate that covers treatments specifically for asds.125 the asd insurance mandate recognizes the demand for coverage of services to children with an asd and attempts to eliminate previous benefit exclusions.126 currently, twenty-three states require insurance coverage for the treatment of asds.127 indiana enacted the first meaningful autism insur 118. see ind. bull. 136, supra note 106, at 1. 119. victoria colliver, state agency sued over new policy on autism, s.f. chronicle, july 1, 2009, http://articles.sfgate.com/2009-07-01/bay-area/17217191_1_autism-spectrumdisorder-treatment-decisions-health-policy; consumer watchdog et al v. cal. dep’t of managed health care, no. bs121397 (cal. super. ct. oct. 20, 2009). 120. in re micheletti v. state health benefits comm., 913 a.2d 842, 847 (n.j. super. ct. app. div. 2007). 121. claxton & lundy, supra note 113, at 13. 122. wheeler v. aetna life ins. co., no. 01 c 6064 2003 u.s. dist. lexis 12742, at *40 (n.d. ill. july 21, 2003); in re micheletti v. state health benefits comm., 913 a.2d 842, 850-51 (n.j. super. ct. app. div. 2007). 123. see redman, supra note 39. 124. claxton & lundy, supra note 113, at 10. 125. bunce & wieske, supra note 55, at 1. 126. pennsylvania hb 1150, supra note 39, at 35. 127. see supra note 7. 2011] autism insurance reform: a comparison of state initiatives 515 ance mandate in 2001.128 it provides broad coverage for asd services, and serves as a model for other states adopting autism insurance mandates.129 1. current state autism insurance mandates common provisions and definitions the wording for autism insurance mandates is intentionally broad because asd affects each person differently and requires individualized treatment.130 the various provisions for the different state statutes can be broken down into eight areas. a. covered persons states vary on both the ages and diagnoses covered by the statute. most states limit the age range for which coverage is required.131 age limits typically cover the person through school age, but a few states restrict coverage to younger children.132 currently, only indiana, massachusetts, 128. ind. code § 27-8-14.2 (2009). 129. katherine kimball, insuring a future: mandating medical insurance coverage of autism related treatments in nebraska, 42 creighton l. rev. 689, 690 (2009). 130. trivedi, supra note 86. 131. ariz. rev. stat. ann. §§ 20-826.04(d)(1), (2) (lexisnexis 2010) (requiring coverage of aba for children under fifteen); colo. rev. stat. § 10-16-104(1.4)(b)(i) (2010) (requiring coverage for children under nineteen); conn. gen. stat. § 38a-514b(d) (2010) (requiring coverage of aba for children under fifteen); fla. stat. § 627.6686(2)(c) (2010) (requiring coverage for children under eighteen, or over eighteen so long as the person is enrolled in high school); 215 ill. comp. stat. ann. 5/356z.14(a) (lexisnexis 2011) (requiring coverage for children under twenty-one); iowa code § 514c.26(1) (west 2010) (requiring coverage for children under twenty-one); kan. stat. ann. § 75-6524(a)(3) (2010) (requiring coverage for children under nineteen); ky. rev. stat. ann. § 304.17a-142(1) (west 2010) (requiring coverage for children under twenty-one); la. rev. stat. ann. § 22:1050(a)(1) (2009) (requiring coverage for children under seventeen); me. rev. stat. ann. 24-a, § 2766(2) (2010) (requiring coverage for children five and under); mo. ann. stat. § 376.1224(5) (west 2010) (requiring coverage for children eighteen and under for aba); mont. code ann. § 33-22-515(1) (2009) (requiring coverage for children eighteen and under); nev. rev. stat. ann. § 689b.0335 (lexisnexis 2010) (requiring coverage for children under eighteen, or until twenty-two so long as the person is enrolled in high school); n.h. rev. stat. ann. § 417-e:2(iii) (lexisnexis 2010) (requiring coverage for children under twenty-one for aba); n.j. stat. ann. § 17b:27-46.1ii(c) (west 2009) (requiring coverage of aba for children under twenty-one); n.m. stat. ann. § 59a-23-11(a) (lexisnexis 2009) (requiring coverage for children nineteen and under, or until twenty-two so long as the person is enrolled in high school); 40 pa. stat. ann. § 764h(a) (west 2009) (requiring coverage for children under twenty-one); s.c. code ann. § 38-71-280(e) (2008) (requiring coverage for children under sixteen); tex. ins. code ann. § 1355.015(a) (west 2009) (requiring coverage for children ages three through five); vt. stat. ann. 8, § 4088i(a) (2010) (requiring coverage for aba for children between eighteen months and six years old or through first grade, whichever comes first). 132. me. rev. stat. ann. 24-a, § 2766(2) (2010) (requiring coverage for children through age five); tex. ins. code ann. § 1355.015(a) (requiring coverage for children ages 516 indiana health law review [vol. 8:2 and wisconsin do not have age limits for asd treatment.133 table 1 presents age limits by state under its autism insurance mandate. table 1. age limits for coverage under autism insurance mandates by state134 state age limit (in years) arizona < 15 (for aba) colorado < 19 connecticut < 15 (for aba) florida < 18 (or so long as enrolled in high school) illinois < 21 iowa < 21 indiana none kansas < 19 kentucky < 21 louisiana < 17 maine < 5 massachusetts none missouri < 18 (for aba) montana < 18 nevada < 18 (or < 22 if enrolled in high school) new hampshire < 21 (for aba) new jersey < 21 (for aba) new mexico < 19 (or < 22 if enrolled in high school) pennsylvania < 21 south carolina < 16 texas 3 – 5 vermont 2 – 6 (or 1st grade, whichever comes first) wisconsin none states may also limit the diagnoses covered under the mandate. while most tie the diagnostic eligibility to the diagnostic and statistical manual of mental disorders (“dsm”),135 they may differ in the specific diagnoses three through five); vt. stat. ann. 8, § 4088i(a) (2010) (requiring coverage for aba for children between eighteen months and six years old or through first grade, whichever comes first). 133. ind. code § 27-8-14.2 (2009); mass. gen. laws ann. 32a, § 25 (west 2010); wis. stat. § 632.895(12m) (2009). 134. see supra note 131. it is important to note that with health care reform, limits previously held at twenty-one years old may be increased to twenty-six years old. see mueller, supra note 40. 135. ariz. rev. stat. ann. §§ 20-826.04(e)(1)(a)-(c) (lexisnexis 2010); colo. rev. stat. § 10-16-104(1.4)(a)(iii) (2010); conn. gen. stat. § 38a-514b(a)(3) (2010); fla. stat. § 627.6686(2)(b) (2010); 215 ill. comp. stat. ann. 5/356z.14(i) (lexisnexis 2011); iowa code § 514c.26(2)(c) (west 2010); ind. code § 27-8-14.2-3; kan. stat. ann. § 756524(b)(2); ky. rev. stat. ann. § 304.17a-141(3) (west 2010); la. rev. stat. ann. § 2011] autism insurance reform: a comparison of state initiatives 517 that are covered. some states cover all pervasive developmental disorders (“pdds”),136 whereas other states may limit coverage to asds.137 one state, new hampshire, does not define the scope of its legislation other than “pervasive developmental disorder or autism.”138 b. covered services autism advocates argue that model legislation should include coverage for diagnosis and assessment, aba therapy, speech, occupational, and physical therapy, psychological care, psychiatric care, and pharmaceutical care.139 indiana allows for broad coverage of asd services, so long as those treatments are medically necessary and prescribed by a physician through a treatment plan.140 to combat the difficulty many families face in accessing aba in particular, some states have mandated coverage just for aba and therapeutic services.141 many states further clarify that treatment specifically includes diagnosis, behavioral therapy (including aba), prescription drug therapy, psychiatric care, psychological care, and therapeutic care (including speech, occupational, and physical therapy).142 however, plans that do not offer coverage for certain services to any member, like 22:1050(g)(3) (2009); me. rev. stat. ann. 24-a, § 2766(1)(b) (2010); mass. gen. laws ann. 32a, § 25(a) (west 2010); mo. ann. stat. § 376.1224(1)(3) (west 2010); mont. code ann. § 33-22-515(2) (2009); n.m. stat. ann. § 59a-23-11(h)(1) (lexisnexis 2009); 40 pa. stat. ann. § 764h(f)(3) (west 2009); s.c. code ann. § 38-71-280(a)(1) (2008); vt. stat. ann. 8, § 4088i(d)(3) (2010). 136. recall that pdds include asds as well as rett’s disorder, and cdd. conn. gen. stat. § 38a-514b(a)(3) (2010); ind. code § 27-8-14.2-3; ky. rev. stat. ann. § 304.17a141(3) (west 2010); la. rev. stat. ann. § 22:1050(g)(3) (2009); me. rev. stat. ann. 24a, § 2766(1)(b) (2010); mass. gen. laws ann. 32a, § 25(a) (west 2010); mo. ann. stat. § 376.1224(1)(3) (west 2010); nev. rev. stat. ann. § 689b.0335(8)(b) (lexisnexis 2010) (lexisnexis 2009); n.m. stat. ann. § 59a-23-11(h)(1); 40 pa. stat. ann. § 764h(f)(3) (west 2009); vt. stat. ann. 8, § 4088i(d)(3). 137. ariz. rev. stat. ann. §§ 20-826.04(e)(1)(a)-(c) (lexisnexis 2010); colo. rev. stat. § 10-16-104(1.4)(a)(iii) (2010); fla. stat. §§ 627.6686(2)(b)(1)-(3) (2010); 215 ill. comp. stat. ann. 5/356z.14(i); iowa code § 514c.26(2)(c) (west 2010); kan. stat. ann. § 75-6524(b)(2) (2010); mont. code ann. §§ 33-22-515(2)(a)-(c) (2009); s.c. code ann. § 38-71-280(a)(1) (2008); wis. stat. § 632.895(12m)(a)(1) (2009). 138. n.h. rev. stat. ann. § 417-e:2 (lexisnexis 2010). 139. press release, autism society of america, supra note 3. 140. ind. code § 27-8-14.2-4(a) (2010); ind. bull. 136, supra note 106, at 2 (noting that service exclusions that are inconsistent with the treatment plan will be considered invalid). 141. ariz. rev. stat. ann. § 20-826.04(a)(2) (lexisnexis 2010); fla. stat. § 627.6686(3)(b) (2010); n.j. stat. ann. § 17b:27-46.1ii(1)(a), (c) (west 2009) (limiting aba coverage to autism only); n.m. stat. ann. § 59a-23-11(a)(2) (lexisnexis 2009); tex. ins. code ann. § 1355.015(c)(1) (west 2009). 142. colo. rev. stat. §§ 10-16-104(1.4)(a)(xii)(a)-(g) (2010); conn. gen. stat. §§ 38a-514b(c)(a)-(g) (2010); iowa code ann. § 514c.26(2)(j) (west 2010); ky. rev. stat. ann. § 304.17a-141(11) (west 2010); mo. ann. stat. § 376.1224(1)(13) (west 2010); nev. rev. stat. ann. § 689b.0335(5) (lexisnexis 2010); 40 pa. stat. ann. § 764h(f)(14) (west 2009); vt. stat. ann. 8, § 4088i(d)(9) (2010). 518 indiana health law review [vol. 8:2 prescription drug coverage, are not required to provide such services just for those members with asd.143 coverage of autism services may be subject to other general policy exclusions and limitations such as coordination of benefits, participating provider requirements, or prohibiting reimbursement for services provided by family or household members.144 to combat denials based on an insurer’s determination that a treatment like aba is experimental, several states have specifically defined the treatments listed in the statute as evidence-based.145 further complicating matters, a few states have included language within their autism insurance reform legislation that reaffirms the state’s obligation to provide services through early intervention programs and public schools while allowing insurers to exclude coverage for services received under idea laws when provided in the school context. however, insurers may still have to provide coverage for those services when done outside the classroom.146 the uncertainty between what constitutes special education, which would be covered by the schools under idea, and what constitutes medical therapy creates a grey zone that could result in children being denied coverage by both their school districts and their insurance companies.147 c. covered providers for quality control purposes, insurers require covered services to be rendered by qualified providers, who at a minimum are licensed in the state where they practice.148 however, aba providers, while able to get national certification, are slow to be recognized or licensed within a state.149 indeed, 143. ind. bull. 136, supra note 106, at 2; colo. rev. stat. § 10-16104(1.4)(a)(xii)(d) (2010); conn. gen. stat. § 38a-514b(c)(b) (2010); me. rev. stat. ann. 24-a, § 2766(2)(e) (2010); n.h. rev. stat. ann. § 417-e:2(i)(b) (lexisnexis 2010). 144. see, e.g., ind. bull., supra note 106, at 2; n.m. stat. ann. § 59a-23-11(b)(4) (lexisnexis 2009); s.c. code ann. § 38-71-280(c) (2008). 145. ariz. rev. stat. ann. § 20-826.04(e)(2) (lexisnexis 2010); colo. rev. stat. § 10-16-104(1.4)(a)(xii) (2010); conn. gen. stat. § 38a-514b(a)(4) (2010); mont. code ann. § 33-22-515(3)(b)(i) (2009); nev. rev. stat. ann. § 689b.0335(8)(e) (lexisnexis 2010); wis. stat. § 632.895(12m)(a)(3) (2009). 146. colo. rev. stat. § 10-16-104(1.4)(i); conn. gen. stat. § 38a-514b(h)(2) (2010); iowa code § 514c.26(7) (west 2010); ky. rev. stat. ann. § 304.17a-142(8) (west 2010); me. rev. stat. ann. 24-a, § 2766(4) (2010); mass. gen. laws ann. 32a, § 25(f) (west 2010); nev. rev. stat. ann. § 689b.0335(7) (lexisnexis 2010); n.j. stat. ann. § 17b:27-46.1ii(1)(f) (west 2009); n.m. stat. ann. § 59a-23-11(b)(5) (lexisnexis 2009); 40 pa. stat. ann. § 764h(d.1) (west 2009); vt. stat. ann. 8, § 4088i(e) (2010). 147. see mueller, supra note 40 (quoting a mother of a child with autism: “the insurance companies are telling us that therapy is educational . . . and the school district is telling us that its medical.”). 148. medical policy, supra note 71, at 6. but see ind. bull. 136, supra note 106, at 2 (noting that indiana does not license aba therapists but that it would be inappropriate for an insurer to deny a claim based on lack of license). 149. see supra section ii. c. 2. b. (v). 2011] autism insurance reform: a comparison of state initiatives 519 some autism insurance mandates do not specifically include certified aba therapists as covered providers.150 to address this issue, some states allow nationally certified behavior therapists to provide treatment.151 other states address the problem by creating a category of autism service providers, which include aba therapists and other providers with specific knowledge and experience with asds.152 d. treatment plans several states require a treatment plan to be submitted to the insurance company.153 the treatment plan must include all elements necessary for the insurer to properly pay claims.154 these elements generally include the in 150. see ind. code § 27-8-14.2; kan. stat. ann. § 75-6524 (2010); n.j. stat. ann. § 17b:27-46.1ii (west 2009); n.m. stat. ann. § 59a-23-11(a); 40 pa. stat. ann. § 764h (west 2009); tex. ins. code ann. § 1355.015 (west 2009); wis. stat. § 632.895(12m). 151. ariz. rev. stat. ann. § 20-826.04(a)(2) (lexisnexis 2010); conn. gen. stat. § 38a-514b(a)(4)(b)(i) (2010); fla. stat. § 627.6686(3)(b) (2010); iowa code § 514c.26(2)(b) (west 2010); me. rev. stat. ann. 24-a, § 2766(1)(c)(1) (2010); mass. gen. laws ann. 32a, § 25(a) (west 2010); mo. ann. stat. § 376.1224(1)(2) (west 2010) (establishes a professional board within the state to license certified bcbas); mont. code ann. § 33-22-515(3)(b)(ii) (2009); nev. rev. stat. ann. §§ 689b.0335(8)(g), (h) (lexisnexis 2010); n.h. rev. stat. ann. § 417-e:2(i)(a) (lexisnexis 2010); 40 pa. stat. ann. § 764h(g)(1) (west 2009). 152. colo. rev. stat. § 10-16-104(1.4)(a)(ii) (2010) (requiring autism service providers to be licensed, certified, or registered by the state licensing board or by a nationally recognized organization, and to have at least one year of experience in working with people with asds); conn. gen. stat. § 38a-514b(a)(2) (2010) (defining autism service provider as any person, entity, or group that provides treatment for asd); iowa code § 514c.26(2)(b) (west 2010) (defining autism service provider as a nationally certified or licensed provider); ky. rev. stat. ann. § 304.17a-141(2) (west 2010) (creating a state licensing board for aba therapists); la. rev. stat. ann. § 22:1050(g)(2) (2009); mo. ann. stat. § 376.1224(1)(2) (west 2010) (defining autism service provider as any licensed provider); nev. rev. stat. ann. § 689b.0335(8)(d) (lexisnexis 2010) (defining “certified autism behavior interventionist” as a person certified by the state board of psychological examiners and who is supervised by a licensed psychologist, behavior analyst, or assistant behavior analyst); 40 pa. stat. ann. § 764h(f)(2) (west 2009) (defining autism service provider as a state licensed or certified person, entity, or group providing treatment of asds pursuant to a treatment plan); vt. stat. ann. 8, § 4088i(d)(2) (2010) (defining autism service provider as any licensed or certified provider). 153. colo. rev. stat. § 10-16-104(1.4)(a)(xiii) (2010); conn. gen. stat. § 38a514b(c) (2010); fla. stat. § 627.6686(4)(a) (2010); iowa code § 514c.26(2)(j) (west 2010); ind. code § 27-8-14.2-4(a) (2009); mo. ann. stat. § 376.1224(4) (west 2010); n.j. stat. ann. § 17b:27-46.1ii(1)(d) (west 2009); n.m. stat. ann. § 59a-23-11(b)(1) (lexisnexis 2009); 40 pa. stat. ann. § 764h(f)(15) (west 2009); s.c. code ann. § 38-71280(b) (2008); tex. ins. code ann. § 1355.015(b) (west 2009). see also, 215 ill. comp. stat. ann. 5/356z.14(f) (lexisnexis 2011); ky. rev. stat. ann. § 304.17a-142(6)(c) (west 2010); mont. code ann. § 33-22-515(6) (2009) (allowing insurers to request a treatment plan when treatment is expected to require continued services); nev. rev. stat. ann. § 689b.0335(5) (lexisnexis 2010); n.h. rev. stat. ann. § 417-e:2(ii) (lexisnexis 2010) (stating that no treatment plan is required but the insurer may request one). 154. see ind. bull. 136, supra note 106, at 1; fla. stat. § 627.6686(7) (2010). 520 indiana health law review [vol. 8:2 dividual’s diagnosis, a list of proposed treatments including: the frequency, duration, and likely outcomes for each; the frequency by which the treatment plan will be updated; and the treating physician’s signature.155 the treatment plan allows several different professionally accepted therapies to address asd symptoms without having to seek individual approval for each service.156 states differ on who may develop and who must sign the treatment plan. some states allow any qualified provider to develop and sign the treatment plan,157 while other states limit the task to only certain providers.158 finally, a few states specifically require a physician to develop and sign the treatment plan.159 the insurance company has a right to periodically review the treatment plan to determine whether the services ordered are medically necessary.160 some states condition the insurer’s review process by requiring a specialist in the treatment of asds to review the plan.161 even without requiring a formal treatment plan, some autism insurance mandates give the insurer the ability to conduct periodic reviews of whether a treatment continues to be medically necessary.162 155. see ind. bull. 136, supra note 106, at 2. fla. stat. § 627.6686(7); 215 ill. comp. stat. ann. 5/356z.14(f) (lexisnexis 2011); n.j. stat. ann. § 17b:27-46.1ii(1)(d) (west 2009); n.m. stat. ann. § 59a-23-11(e) (lexisnexis 2009); s.c. code ann. § 3871-280(d) (2008). 156. autism speaks, arguments, supra note 4, at 14. 157. conn. gen. stat. § 38a-514b(c) (2010) (allowing physician, psychologist or social worker to develop a treatment plan); 215 ill. comp. stat. ann. 5/356z.14(f). 158. colo. rev. stat. § 10-16-104(1.4)(a)(xiii) (2010); iowa code § 514c.26(2)(k) (west 2010) (requiring either a physician or clinical psychologist to sign the treatment plan); 40 pa. stat. ann. § 764h(f)(15) (west 2009) (requiring either a physician or clinical psychologist to sign the treatment plan). 159. fla. stat. § 627.6686(4)(a) (2010); ind. code § 27-8-14.2-4(a) (2009); mont. code ann. § 33-22-515(6) (2009); n.j. stat. ann. § 17b:27-46.1ii(1)(d) (west 2009); n.m. stat. ann. § 59a-23-11(e)(6) (lexisnexis 2009); tex. ins. code ann. § 1355.015(b) (west 2009) (allowing only a physician to sign the treatment plan). 160. ind. bull. 136, supra note 106, at 1; colo. rev. stat. § 10-16-104(1.4)(h); conn. gen. stat. § 38a-514b(f)(1) (2010); 215 ill. comp. stat. ann. 5/356z.14(f); iowa code § 514c.26(10) (west 2010); kan. stat. ann. § 75-6524(a)(7)(a) (2010); la. rev. stat. ann. § 22:1050(f) (2009); nev. rev. stat. ann. § 689b.0335(5) (lexisnexis 2010); n.j. stat. ann. § 17b:27-46.1ii(1)(g) (west 2009); 40 pa. stat. ann. § 764h(i) (west 2009); s.c. code ann. § 38-71-280(c) (2008) (allowing insurers to review the treatment plan every six months or sooner if the treating physician agrees). 161. ind. bull. 136, supra note 106, at 1; 215 ill. comp. stat. ann. 5/356z.14(g) (lexisnexis 2011) (stating that an expert in asd is required only when challenging medical necessity). there is no standard definition of what makes someone an expert in asds, however, generally expertise is determined based on scope of practice and professional reputation. 162. kan. stat. ann. § 75-6524(a)(7)(b) (2010) (stating that insurer may review and deny treatments based on medical necessity); ky. rev. stat. ann. § 304.17a-142(6)(a) (west 2010) (stating that insurer can request utilization review annually); me. rev. stat. ann. 24-a, § 2766(2)(b) (2010) (stating that insurer may require the proscribing physician or psychologist to provide evidence of ongoing medical necessity). 2011] autism insurance reform: a comparison of state initiatives 521 e. maximum benefit amounts only a few states, indiana, massachusetts, texas and vermont, do not place maximum yearly benefit limits on asd services.163 however, most states set an annual maximum benefit amount for asd services; sometimes this limit just applies to aba.164 some states lower the yearly maximum benefit as the child gets older.165 for example, arizona allows benefits up to $50,000 per year for a child under the age of nine but decreases that amount to $25,000 per year for a child ages nine to sixteen.166 this tiered approach emphasizes the need for early intensive therapy while constraining the overall costs associated with treating a child with an asd. table 2 presents a summary of maximum benefit amounts by state. 163. ind. code § 27-8-14.2 (2009); mass. gen. laws ann. 32a, § 25 (west 2010); tex. ins. code ann. § 1355.015 (west 2009); vt. stat. ann. 8, § 4088i (2010). 164. ariz. rev. stat. ann. §§ 20-826.04(d)(1), (2) (lexisnexis 2010) (limiting aba to $50,000 per year up to age nine, $25,000 per year for an eligible person aged nine to sixteen); colo. rev. stat. § 10-16-104(1.4)(b)(i) (2010) (limiting aba to $34,000 per year for a child under nine, $12,000 per year for a child aged nine to eighteen); conn. gen. stat. § 38a-514b(d) (2010) (limiting aba therapy to $50,000 per year for a child under nine, $35,000 per year for a child between nine and twelve, $25,000 per year for a child between thirteen and fourteen); fla. stat. § 627.6686(4)(b) (2010) (limiting aba and therapeutic services to $36,000, $200,000 in total lifetime benefits); 215 ill. comp. stat. ann. 5/356z.14(b) (lexisnexis 2011) (limiting benefits to $36,000 per year); iowa code § 514c.26(3) (west 2010) (limiting coverage to $36,000 per year); kan. stat. ann. §§ 756524(a)(3), (4) (2010) (limiting coverage to $36,00 per year for children under seven and $27,000 per year for children seven through nineteen); ky. rev. stat. ann. §§ 304.17a142(2)(a), (b), -143(2) (west 2010) (limiting benefits to $50,000 for children under seven and $1,000 per month for children between seven and twenty-one for large group plans; $1,000 per month for small group and individual plans); la. rev. stat. ann. § 22:1050(d)(1) (2009) (limiting all asd services to $36,000 per year, $144,000 in total lifetime benefits); me. rev. stat. ann. 24-a, § 2766(2)(d) (2010) (limiting benefits to $36,000 per year for aba); mo. ann. stat. § 376.1224(5) (west 2010) (limiting benefits to $40,000 per year for aba, but the limit may be exceeded upon a showing of medical necessity); mont. code ann. §§ 33-22-515(4)(a)(i), (ii) (2009) (limiting coverage to $50,000 per year for children eight and under, $20,000 per year for children nine through eighteen); nev. rev. stat. ann. § 689b.0335(2)(a) (lexisnexis 2010) (limiting aba to $36,000 per year); n.h. rev. stat. ann. § 417-e:2(iii) (lexisnexis 2010) (limiting benefits to $36,000 per year for children twelve and under and $27,000 per year for children thirteen through twenty-one years old); n.j. stat. ann. § 17b:27-46.1ii(1)(c)(3)(a) (west 2009) (limiting coverage to $36,000 per year); n.m. stat. ann. § 59a-23-11(b)(2) (lexisnexis 2009) (limiting coverage to $36,000 per year, $200,000 in total lifetime benefits); 40 pa. stat. ann. § 764h(b) (west 2009) (limiting coverage to $36,000 per year); s.c. code ann. § 38-71280(e) (2008) (limiting aba to $50,000 per year); wis. stat. § 632.895(12m)(b) (2009) (limiting intensive services like aba and speech therapy to $50,000 per year, $25,000 limit on other asd services). it is also important to note that with new health care reform laws, the maximum lifetime benefit limits may no longer be allowed. see mueller, supra note 40. 165. see supra note 164: arizona, colorado, connecticut, kansas, kentucky, montana, new hampshire. 166. ariz. rev. stat. ann. §§ 20-826.04(d)(1), (2) (lexisnexis 2010). 522 indiana health law review [vol. 8:2 table 2. maximum benefit amounts by state for asd services167 state maximum yearly benefit amount number in parentheses indicates age restrictions associated with the amount. aba indicates that limits are applied specifically to aba therapy arizona aba: $50,000 (< 9); $25,000 (9-16) colorado aba: $34,000 (< 9); $12,000 (9-18) connecticut aba: $50,000 (< 9); $35,000 (9-12); $25,000 (13-14) florida aba/therapeutic services: $36,000 illinois $36,000 iowa $36,000 indiana none kansas $36,000 (< 7); $27,000 (7-19) kentucky $50,000 (<7); $1,000 per month (7-21); $1,000 per month for small group and individual plans louisiana $36,000 maine aba: $36,000 massachusetts none missouri aba: $40,000 (limit may be increased by medical necessity) montana $50,000 (< 8); $20,000 (9-18) nevada aba: $36,000 new hampshire $36,000 (<12); $27,000 (13-21) new jersey $36,000 new mexico $36,000 pennsylvania $36,000 south carolina $50,000 texas none vermont none wisconsin aba, speech therapy: $50,000; $25,000 for other asd services f. prohibiting limits on the number of visits due to the frequency of visits needed for intensive aba and speech therapy, many states prohibit insurance companies from placing limits on the number of visits for asd treatments.168 this is one instance where in 167. see supra note 164. 168. ind. bull., supra note 106, at 2; conn. gen. stat. § 38a-514b(e)(1) (2010); 215 2011] autism insurance reform: a comparison of state initiatives 523 surers may be required to go beyond what they provide for other users of certain services. for example, where speech therapy may be limited to a certain number of sessions for illness in general, speech therapy visits for individuals with asd may not be limited when the treatment is prescribed as medically necessary. g. prohibiting termination or refusal to renew a policy as previously discussed, insurance companies may have blanket exclusions for asds.169 most autism insurance mandates prohibit blanket exclusions by providing that, “an insurer may not deny or refuse to issue coverage on, refuse to contract with, or refuse to renew, refuse to reissue, or otherwise terminate or restrict coverage on an individual under an insurance policy solely because the individual is diagnosed with an asd.”170 h. types of insurance plans affected there are several mechanisms for accessing health insurance. by far the most common is through employer-sponsored plans.171 two primary ways employers provide access to coverage is through self-funded plans or group benefit plans. self-funded insurance policies are typically offered to employees by large companies or government employers.172 the employer pays the employees’ health care costs from its own pocket and assumes the risk that it will be able to cover all its employees’ health care needs.173 because these self-funded plans are not actually insurance, states generally cannot regulate their content or activities and, therefore, cannot require them to offer any specified benefits.174 this means that states cannot re ill. comp. stat. ann. 5/356z.14(b) (lexisnexis 2011); iowa code § 514c.26(3) (west 2010); kan. stat. ann. § 75-6524(b)(2) (2010); ky. rev. stat. ann. § 304.17a-142(3) (west 2010); la. rev. stat. ann. § 22:1050(b) (2009); me. rev. stat. ann. 24-a, § 2766(2)(c) (2010); mass. gen. laws ann. 32a, § 25(e) (west 2010); mo. ann. stat. § 376.1224(7) (west 2010); nev. rev. stat. ann. § 689b.0335(4) (lexisnexis 2010); n.j. stat. ann. § 17b:27-46.1ii(1)(c)(1) (west 2009) (prohibiting limits on visits for behavior intervention only); 40 pa. stat. ann. § 764h(b) (west 2009); vt. stat. ann. 8, § 4088i(b) (2010); wis. stat. § 632.895(12m)(b)(2) (2009). 169. see supra part ii.c.2.a. 170. ariz. rev. stat. ann. § 20-826.04(a)(1) (lexisnexis 2010); colo. rev. stat. §§ 10-16-104(1.4)(d), (g) (2010); fla. stat. § 627.6686(6) (2010); 215 ill. comp. stat. ann. 5/356z.14(e) (west 2011); ind. code § 27-8-14.2-4(a) (2009); la. rev. stat. ann. § 22:1050(a)(2) (2009); nev. rev. stat. ann. § 689b.0335(3)(b) (lexisnexis 2010); n.m. stat. ann. § 59a-23-11(d) (lexisnexis 2009); s.c. code ann. § 38-71-280(b) (2008). 171. claxton & lundy, supra note 113, at 1. 172. id. at 3. 173. id. 174. id. at 17. self-funded plans are regulated by erisa, which preempts state regulations. despite not being required to comply with mandated coverage, several self-insured companies provide coverage for autism. see information for families with self-funded health insurance plans, autism speaks, http://www.autismvotes.org/site/ 524 indiana health law review [vol. 8:2 quire private self-funded plans to cover asd services using a mandate.175 however, despite state employees’ health plans often being self-funded, some states have extended the mandate to apply to state government employees and their dependents because the state has control over its own employees’ coverage.176 group benefit plans are typically purchased by an employer or group, such as an organization, union, or professional association.177 there are generally no enrollment exclusions within a group benefit plan, meaning anyone in the group may join.178 these plans are very common and are highly regulated by the states.179 in fact, nearly all autism insurance mandates apply to group policies.180 while regulated similar to large group plans, small groups of less than fifty members are exempt in some states from the asd mandate.181 because insurance regulation is left to the individual states,182 there is an unusual interaction between state laws when an employer is based in a state without an autism insurance mandate but has employees living in a state with an autism insurance mandate. for example, if a company uses an insurance plan covered by the law where it is headquartered, that state’s insurance laws would govern, even if the company had employees working in indiana.183 on the other hand, employees based in other states that work for a company headquartered in indiana that uses an indiana health insurance policy, would be covered by the mandate.184 similarly, missouri requires policies written outside of missouri, but insuring missouri residents, c.frkni3pcime/b.5216011/k.1245/selfinsured_companies_and_autism_coverage.htm (last visited jan. 8, 2011) (listing companies with self-insured health plans that have opted to provide coverage for autism therapies). 175. but see, mo. ann. stat. § 376.1224(12)(2) (west 2010) (applying the mandate to self-insured group plans to the extent not preempted by federal law); mont. code ann. § 33-22-515(8) (2009) (applying the mandate to any self-funded program that is not regulated by erisa. 176. fla. stat. § 627.6686(2)(d) (2010); iowa code § 514c.26(1) (west 2010); kan. stat. ann. § 75-6524 (2010); mass. gen. laws ann. 32a, § 25 (west 2010); mo. ann. stat. § 376.1224(12) (west 2010); mont. code ann. § 33-22-515(8) (2009); nev. rev. stat. ann. § 287.0276 (lexisnexis 2010); n.j. stat. ann. §§ 17b:27-46.1ii(9), (10) (west 2009); s.c. code ann. § 38-71-280(a)(4) (2008); vt. stat. ann. 8, § 4088i(d)(6) (2010). 177. claxton & lundy, supra note 113, at 3. 178. id. at 7. 179. id. at 9. 180. see supra note 7. but see, iowa code § 514c.26(1) (west 2010) (requiring asd coverage only for state-funded employee health plans); kan. stat. ann. § 75-6524 (2010). 181. ariz. rev. stat. ann. § 20-826.04(b)(1) (lexisnexis 2010); fla. stat. § 627.6686(2)(d) (2010); la. rev. stat. ann. § 22:1050(h)(1) (2009); mass. gen. laws ann. 32a, § 25(g) (west 2010) (stating that small group employers can seek exemption if the mandate would increase their premium cost by more than 2.5% in a year); 40 pa. stat. ann. § 764h(e)(1) (west 2009); s.c. code ann. § 38-71-280(a)(4) (2008). 182. see claxton & lundy, supra note 113, at 8. 183. trivedi, supra note 86. 184. id. 2011] autism insurance reform: a comparison of state initiatives 525 to provide asd coverage.185 therefore, employees of larger companies with locations nationwide may find it difficult to determine whether their health plan is covered by an asd mandate, as the employee’s state may differ from the company’s headquartered state on asd coverage. when people do not have health insurance through their employer, they may purchase an individual health insurance policy. individual policies are often more expensive because there is not an associated group to pool the risk.186 like small-group plans, states will sometimes exempt individual plans from the asd mandate.187 however, a few states require insurers selling individual policies to offer the option to include coverage for asd using a rider, which allows the consumer to purchase the coverage as an option with a corresponding increase in premiums.188 table 3 presents a summary of plans covered by autism insurance mandates. table 3. plans covered by autism insurance mandate by state189 state se lffu nd ed la rg e g ro up sm al l g ro up in di vi du al h m o st at e/ lo ca l e m p. st at esp on so re d arizona n y n n colorado n y y n y connecticut y y florida y n n y 185. mo. ann. stat. § 376.1224(2) (west 2010). 186. claxton & lundy, supra note 113, at 6. 187. ariz. rev. stat. ann. § 20-826.04(b)(1) (lexisnexis 2010); colo. rev. stat. § 10-16-104(1.4)(a)(iv) (2010) (individual policies not required to provide coverage but if the individual policy covers autism, it must follow the mandate); fla. stat. § 627.6686(2)(d) (2010); la. rev. stat. ann. § 22:1050(h)(2) (2009); s.c. code ann. § 38-71-280(a)(4) (2008). 188. ind. code § 27-8-14.2-5(a) (2009); mo. ann. stat. § 376.1224(13) (west 2010); nev. rev. stat. ann. § 689a.0435 (lexisnexis 2010). 189. as definitions of insurance plans may vary slightly by state, readers are encouraged to visit their state’s insurance regulatory body to determine what types of plans are available and to confirm whether their particular plan is covered by the mandate. this table serves merely as a broad overview. “small group” refers to plans with less than fifty enrollees, “state-sponsored” refers to state sponsored health insurance programs like children’s health insurance programs (“chip”) or expansion to medicaid coverage. arizona’s statute applies to group insurance provided by a hospital or medical service corporation plan. kansas’ legislature is studying the effect of the mandate on state employee plans before determining whether it should be expanded to private insurers. kan. stat. ann. § 75-6524(c)(2). texas requires state mandated plans to cover asd treatments, and it is unclear which specific plans will be covered. 526 indiana health law review [vol. 8:2 state se lffu nd ed la rg e g ro up sm al l g ro up in di vi du al h m o st at e/ lo ca l e m p. st at esp on so re d illinois y y y y iowa n y indiana y y y y kansas y kentucky y y y louisiana y n n y maine y y y massachusetts y y y y missouri y y y y y n montana y y y y nevada y y y y y new hampshire y y y new jersey y y a new mexico y y y pennsylvania y n y y south carolina y n n y y texas n vermont y y y y y y wisconsin y y y y 2. autism treatment acceleration act of 2009 (“ataa”) the autism treatment acceleration act of 2009 (“ataa”), if enacted as proposed, would require both self-insured group plans and individual health plans to provide coverage for the diagnosis and treatment of asds.190 further, ataa would require every state to mandate coverage for asds.191 current asd mandate statutes that do not meet the minimum set by the ataa may be preempted and the ataa will govern.192 how 190. ataa, s. 819, 111th cong. § 12 (2009) (amending erisa 29 u.s.c. 1185). the bill stalled in committee. however, for purposes of analysis, this note addresses the general text and spirit of the bill since it is possible that the bill could be reintroduced in the next session. 191. ataa, s. 819, 111th cong. § 12 (2009). 192. it is unclear how the ataa will preempt state statutes, either in total or by provi2011] autism insurance reform: a comparison of state initiatives 527 ever, states with autism insurance mandates that meet the standards set out in the ataa will not be preempted.193 similar to indiana’s mandate, the ataa does not have age restrictions or maximum benefit amounts.194 interestingly, the ataa does not tie diagnostic eligibility to the dsm, and it includes all pdds for the section amending erisa but only asds for the section amending phsa.195 the ataa does not require a treatment plan and allows a wide range of professionals to order treatment, so long as the treatment is medically necessary.196 the ataa lists several covered services, including diagnosis, aba, pharmacy care, psychological and psychiatric care, and therapeutic care.197 the ataa prohibits covered plans from denying coverage on the basis that the service is necessary to develop, maintain, or restore skills or functioning or to prevent loss of skills or functioning.198 state, local, and tribal government health plans would generally be covered by the ataa.199 however, a state, local, or tribal government employer that provided its employees with self-funded health plan coverage could opt out of the ataa’s requirements, just as self-funded state, local, and tribal government health plans can opt out of other federal insurance mandates.200 e. controversies and asd insurance reform underlying the push for asd insurance reform is a debate among autism advocates, the state, and the insurance industry regarding who should pay for asd services, and what the real impact of an asd mandate will be. 1. who should pay for asd services? opponents of autism insurance reform suggest that the autism insurance mandate is an attempt by the state to shift costs to private insurers.201 sion. 193. ataa, s. 819, 111th cong. § 12(e)(1) (2009). 194. compare ind. code § 27-8-14.2 (2009), with ataa, s. 819, 111th cong. § 12 (2009). 195. ataa, s. 819, 111th cong. § 12(a)(f)(1) (2009). 196. ataa, s. 819, 111th cong. § 12(a)(f)(3) (2009) (defining treatments as services prescribed, provided, or ordered by a physician, psychologist, or other qualified professional who determines the care to be medically necessary). 197. ataa, s. 819, 111th cong. §§ 12(a)(f)(2), (3)(a)-(e) (2009). 198. ataa, s. 819, 111th cong. § 12 (2009). 199. ataa, s. 819, 111th cong. § 12(b) (2009) (amending public health service act (“phsa”) 42 u.s.c. 300gg-4). 200. the autism treatment acceleration act (ataa) insurance provision (s. 819, section 12): potential autism community issues and autism speaks response, autism speaks, at 2 (2009), http://www.autismvotes.org/atf/cf/%7b2a179b73-96e2-44c3-88161b1c0be5334b%7d/fact% 20sheet%20-%20ataa%20insurance%20provision.pdf (last visited jan. 10, 2011) [hereinafter autism speaks, response]. 201. pennsylvania hb 1150, supra note 39, at 36. 528 indiana health law review [vol. 8:2 historically, the state carried the burden of providing services like aba and speech therapy through early intervention and school programs.202 a mandate is not justified, opponents argue, when coverage for services are already available.203 concerning aba therapy, opponents of insurance reform argue that aba is more accurately described as educational and should, therefore, be provided by the schools.204 supporters for asd insurance reform point to the inadequacies of the public education system in dealing with children with asds.205 idea, the law guaranteeing a free and appropriate public education for children with disabilities, has historically failed to produce the statute’s maximum funding provided to states, forcing public schools across the nation to absorb $381.8 billion in special education costs that are left unfunded.206 therefore, supporters of insurance reform argue that reliance on the education system to treat individuals with an asd places an unmanageable burden on a school’s finances.207 supporters for asd insurance reform suggest that without private insurance coverage, treatment is simply not going to happen.208 still, opponents of autism insurance reform argue that the fix should be with the education system, not by shifting the cost to private insurers.209 the center for affordable health insurance notes that, “[i]f legislators want to help these families, they could go beyond the idea scope and create programs that do just that and fund them from general revenues rather than try to force those costs onto health insurance, which will just increase others’ premiums.”210 in supporting the role of insurance coverage for asd services, advocates often compare treatment for asds to treatment for other chronic illnesses typically covered by health insurance.211 asd services focus on controlling or diminishing symptoms and other associated impairments. in this way, supporters of insurance reform argue that asds do not differ from numerous other chronic medical disorders, like hypertension, diabetes, or asthma, for which health insurance routinely covers treatment.212 advocates also point to the status of the provider giving the diagnosis as an argument in favor of health insurance coverage. supporters argue that since a 202. see supra part ii.b.1. 203. pennsylvania hb 1150, supra note 39, at 10. 204. see bunce & wieske, supra note 55, at 1. 205. kimball, supra note 129, at 690. 206. id. at 715-16. 207. id. at 690. 208. see generally autism speaks, arguments, supra note 4 (discussing the need for asd insurance reform). 209. bunce & wieske, supra note 87, at 1. 210. victoria bunce & jp wieske, health insurance mandates in the states 2009 2 (the council for affordable health insurance 2009), at 2. 211. press release, autism society of america, supra note 3. 212. pennsylvania hb 1150, supra note 39, at 4. 2011] autism insurance reform: a comparison of state initiatives 529 medical doctor or a clinical psychologist diagnoses asds and those providers prescribe treatment, asds should be considered medical conditions covered by health insurance.213 2. financial impact of asd insurance reform the debate about whether health insurance should ultimately be responsible for covering the cost of asd treatments or whether states should reform their service delivery systems will continue. however, the reality concerning an asd mandate’s effect on premiums is not something legislators can easily ignore. while aba is an expensive treatment, many argue that failure to provide such treatment would result in greater long-term societal costs.214 in response, opponents argue that the premium increase required to pay for this added coverage could force more people to drop insurance coverage, which may also result in increased societal costs.215 balancing the long-term savings to taxpayers against the immediate impact on premium rates is not easy for a legislator to do when faced with angry voters on both sides of the controversy. supporters of autism insurance reform point to the estimated cost saving to taxpayers through reduced use of state-sponsored social services across the individual’s lifespan.216 the estimated cost of providing statesponsored services is extraordinary and decreases resources available to address the needs of other citizens.217 while early behavioral intervention does not guarantee success for all, it does decrease the likelihood that individuals with asd will need prolonged care throughout their life.218 lack of early intervention limits the number of individuals with asd who are able to achieve higher levels of functioning; thus, indirectly affecting public schools and medicaid services, which are required to provide specialized education and more intense psychiatric treatment.219 beginning with the first autism insurance mandate enacted in 2001, states have come to realize the long-term benefits of requiring insurance carriers to cover asd services. for example, the pennsylvania commonwealth insurance department estimated that medicaid could save $16.5 to $22.2 million in the first year following the adoption of asd insurance reform.220 in contrast, funds once spent on services for asd may be merely 213. press release, autism society of america, supra note 3. 214. autism speaks, arguments, supra note 4, at 16. 215. bunce & wieske, supra note 210, at 3. 216. autism speaks, arguments, supra note 4, at 16. 217. pennsylvania hb 1150, supra note 39, at 26. 218. id. at 24. 219. id. at 23-24. 220. id. at 26. 530 indiana health law review [vol. 8:2 shuffled into another funding category, leaving taxpayers without a reduction in spending. asd insurance reform supporters even suggest that mandates can save insurance providers money. mandated services that are preventive in nature can mitigate other long-term health costs, thereby justifying the initial cost of the mandate.221 for example, the use of aba can save insurance companies money over time by reducing the need for expensive inpatient hospitalizations.222 on the other hand, while mandates make health insurance more comprehensive, mandates also make it more expensive, as insurers must now pay for care consumers previously funded out of their own pockets.223 like states, insurance companies are concerned about the rapid increase in the number of individuals with asd and how that will affect the companies’ ability to keep premiums affordable.224 asd insurance reform is estimated to add approximately one percent to premium costs.225 the indiana legislative services agency estimates that indiana’s asd mandate increases premiums by $0.44 to $1.67 per member per month.226 advocates argue that for only a modest effect on premiums, asd insurance reform holds the promise of significantly improving the lives of thousands of children.227 as an additional guard against rapid premium increases following introduction of an asd insurance mandate, massachusetts allows insurers, corporations, or hmos to seek exemption from the requirement to cover aba for three years if the entity can show that including the treatment would exceed one percent of the premiums charged.228 following the three year period, the entity would be required to cover aba.229 while a program like this delays the availability of aba for families, it would allow the entity to gradually increase its premiums across a three year time span, rather than increasing premiums in one large lump sum. insurers argue that the problem is not just with the autism mandate, but includes the accumulated effects of multiple mandates that price many people out of the market.230 the number of mandates differs by state. idaho has the lowest number of mandates at thirteen; rhode island has highest 221. id. at 42. 222. id. at 38. 223. bunce & wieske, supra note 223, at 1. 224. id. at 3. 225. id. at 5; pennsylvania hb 1150, supra note 39, at 43. 226. ind. leg. serv. agency, fiscal impact statement ls 6861, insurance coverage for autism 3 (2001), available at http://www.in.gov/legislative/bills/2001/pdf/ fiscal/hb1122.006.pdf. 227. autism speaks, arguments, supra note 4, at 15. 228. mass. gen. laws ann. 32a, § 25(g) (west 2010). 229. mass. gen. laws ann. 32a, § 25(g)(2) (west 2010). 230. bunce & wieske, supra note 210, at 2. 2011] autism insurance reform: a comparison of state initiatives 531 at seventy, whereas indiana has thirty-four mandates.231 the insurance industry lobby notes that mandates require insurers to pay more claims, and eventually they must raise premiums to cover those costs.232 opponents argue that mandated benefits increase the cost of basic health coverage from twenty to fifty percent, depending on the number of mandates, the benefit design, and the cost of the initial premium.233 that additional cost may be the determining factor in whether or not a person can afford health insurance.234 when health insurance costs increase, more people, especially healthy people, drop or decline coverage leading to adverse selection.235 adverse selection occurs when less healthy people disproportionately enroll in a risk pool with a low number of healthy people.236 therefore, mandates that drive up the cost of health insurance may lead younger and healthier people to cancel their coverage, leaving the pool smaller and sicker.237 to summarize, the main controversies surrounding asd insurance reforms focus on who should be financially responsible for providing services to individuals with asd. while both states and insures recognize the benefits of asd services, neither wants to be responsible for their enormous cost. states, looking to reap the benefits of long-term savings to public services, have shifted the responsibility to private insurers through asd insurance reform. but is asd insurance reform working? iii. analysis a. asd insurance mandates even though insurance mandates help address some of the ways insurers deny coverage for asd treatments, the problems persist. since many asd insurance mandates are just being implemented, there is not much data available on how well the mandates are working to ensure access to services for individuals with asd. kansas and missouri have built in to their legislation requirements for ongoing study of the effects of autism mandates on quality of services, associated costs through increased premiums, and savings realized by tax-payer funded programs.238 more states should en 231. id. at 4. 232. see gail a. jensen & michael a. morrisey, mandated benefit laws and employer-sponsored health insurance 12 (health ins. ass’n of am. 1999). 233. bunce & wieske, supra note 210, at 1. 234. council for affordable health insurance (“cahi”), 2009 sate legislators' guide to health insurance solutions (2009), available at http://www.cahi.org/cahi_contents/ resources/pdf/statelegguide2009.pdf; pennsylvania hb 1150, supra note 39, at 27. 235. claxton & lundy, supra note 113, at 6. 236. id. 237. bunce & wieske, supra note 55, at 1. 238. kan. stat. ann. § 75-6524(c) (2010) (stating that a study will be used to deter532 indiana health law review [vol. 8:2 courage the collection and analysis of this type of information because without this information, one cannot adequately determine the effect these mandates have on both the families of children with asds as well as the cost to the general public. however, based on the common provisions discussed above, several issues may pose problems as consumers request services covered under asd insurance reform measures. 1. covered persons a. age both florida and south carolina require a diagnosis prior to a certain age to qualify for asd benefits.239 restricting the age for when a child must be diagnosed places a burden on families to seek a diagnosis quickly. this requires families to be cognizant of any developmental delays in their child and be motivated enough to seek assistance from a doctor. moreover, it requires primary care physicians to acknowledge the parents’ concerns and make appropriate and timely referrals to specialists, who may have lengthy waiting lists. for individuals with asperger’s syndrome, who generally receive a diagnosis later in childhood, baseline age restrictions have the potential to exclude them completely from mandated benefits. early detection and intervention are critical to the ultimate functioning level of people with asds. however, asd mandates that cap the age at which benefits may be received ignore the continuing challenges faced by individuals with asd.240 the national institute of child health and human development notes that, “[i]t is never too late to benefit from treatment. people of all ages with asds at all levels of ability generally respond positively to well-designed interventions.”241 costs are an important consideration, and restricting the age for which asd mandates apply is one way to reduce costs. however, states should be aware of the potential societal costs associated with denying coverage to older adolescents and adults with asd compared to any immediate cost savings realized with age restrictions. b. diagnosis several states restrict the diagnoses covered under their mandate to mine whether the mandate should be expanded to private insurance plans); mo. ann. stat. § 376.1224(19) (west 2010). 239. fla. stat. § 627.6686(2)(c) (2010); s.c. code ann. § 38-71-280(e) (2008) (requiring a diagnosis by eight years old). 240. it is important to note that with recent health care reform, the limits for all policies may be increased to include individuals up to age twenty-six. see mueller, supra note 40. 241. nih pub no. 05-5592, supra note 28. 2011] autism insurance reform: a comparison of state initiatives 533 asds only.242 while most states tie coverage to the most current edition of the dsm, other states either tie coverage to a specific edition of the dsm or do not tie coverage to the dsm at all.243 indeed, the ataa language as it stands does not relate eligibility to the dsm.244 the next edition of the dsm is set to for release in 2012 and will likely reflect a dramatic shift in diagnostic conceptualization.245 disorders like asperger’s syndrome and pdd-nos will cease to exist as independent disorders but will instead be covered under the broader designation, autism spectrum disorders.246 it is unclear how this change will affect statutes tied to current dsm diagnostic categories. for statutes that limit coverage to only certain diagnoses but tie the definition to the current version of the dsm, the change has the potential to broaden the scope of individuals covered under the mandate. however, statutes that list covered diagnoses but do not tie coverage to the dsm risk confusion as diagnoses like pdd-nos and asperger’s syndrome fade from use. finally, statutes that refer to diagnoses in a specific edition of the dsm risk confusion in determining whether individuals diagnosed under the new diagnostic criteria fit the old definitions referenced in the statute. it is unclear whether insurers would deny coverage based on an old diagnosis, require a new diagnosis using new criteria, or challenge the applicability of the mandate to a class of people previously not covered. to avoid these problems, legislators should amend autism insurance reform legislation definitions to cover both the old diagnoses as well as the new.247 furthermore, state insurance regulating agencies should be encouraged to develop appropriate guidelines and to collaborate with both providers and insurers to ensure that transition to a new diagnostic system does not disrupt services. 2. covered services compared to other disorders, research into treatments for asd is in its infancy. fortunately, most asd mandates specifically outline what treatments are to be covered, thereby reducing the likelihood of those services 242. see supra note 137. 243. see supra note 135. 244. ataa, s. 819, 111th cong. § 12(a)(f)(1) (2009). 245. 299.00 autistic disorder, supra note 9. 246. id. (reflecting the colloquial understanding of the relationship among the included disorders and expanding the spectrum to include cdd). 247. for example, the following language could be used where the list of inclusive diagnoses could be modified to include only those populations intended by the legislature to be covered under the mandate: “autism spectrum disorders means any of the following disorders as defined by the dsm edition in force when the diagnosis was made: autistic disorder, asperger’s syndrome, pervasive developmental disorder, not otherwise specified (pddnos), childhood disintegrative disorder (cdd), rett’s disorder, or autism spectrum disorder (asd).” 534 indiana health law review [vol. 8:2 being denied as experimental, educational, or habilitative.248 however, without a provision that allows the potential for new treatment modalities, it is possible the mandate could ultimately end up restricting services available to individuals with asd. one solution is to broaden the covered treatments to include any evidence-based treatment prescribed in a treatment plan.249 however, a broad provision, like the one used in indiana’s mandate, would need support with strong interpretive guidelines from the state’s insurance regulating agency outlining which treatments are considered evidence-based.250 currently, there is an effort to include certain services, like aba, as “essential benefits” for the purpose of the newly enacted health care reform law.251 3. covered providers while a licensed clinician may supervise the development of an aba program or assessment of a child’s progress, unlicensed individuals typically provide the bulk of aba services. many health insurance benefit contracts only provide coverage for services rendered by licensed clinicians252 and states cannot force insurers to pay for services provided by unlicensed providers.253 while there is national certification available for aba therapists at both the supervisor and direct therapist levels,254 many states do not yet recognize these individuals for state licensing purposes.255 a lack of recognition for nationally credentialed aba therapists severely restricts the number of qualified providers available, which in turn drives up the demand and cost for those providers.256 granting a state license to those with only the national aba credentials would accomplish three main goals toward reducing the cost of aba. first, it would ensure that there is state oversight and quality control, which would keep unqualified people from rendering services and provide con 248. see supra note 141 and accompanying text. 249. see ind. code § 27-8-14.2-4(a) (2009); ind. bull. 136, supra note 106, at 2. see also colo. rev. stat. § 10-16-104(1.4)(a)(xii) (2010); vt. stat. ann. 8, § 4088i(d)(7) (2010) (giving “medically necessary” a broad definition). 250. see ind. bull. 136, supra note 106. 251. shaun heasley, pressure mounts to include special needs benefits in insurance coverage, disability scoop (oct. 26, 2010), http://www.disabilityscoop.com/2010/10 /26/special-needs-insurance/10894/ (“when health care reform legislation takes full effect in 2014, insurers will be required to offer certain minimum benefits . . . . what qualifies as an ‘essential benefit’ is currently being determined by the department of health and human services.”). 252. see, e.g., medical policy, supra note 71. 253. see, e.g., la act 648 tip sheet, supra note 103; minutes, supra note 93, at 6. 254. becoming certified, supra note 105. 255. ind. bull. 136, supra note 106, at 2; la act 648 tip sheet, supra note 103. 256. for example, there are only seventy-three certified aba practitioners in indiana. certificant registry search results, supra note 105. 2011] autism insurance reform: a comparison of state initiatives 535 sumer protection. second, recognition of national certification would encourage more people to become therapists. this would allow market forces to reduce the costs of aba through the increased availability of providers and competition. finally, once aba therapists attain qualified provider status, insurers would be able to bargain for reduced rates by including those providers in their network. even when a state does not recognize aba therapists for state licensing purposes, there are ways to ensure treatment is not being denied due to the lack of a credentialed provider. for example, the indiana department of insurance has said that despite its lack of state recognition for aba therapists, “it is . . . inappropriate at this time for an insurer to deny a claim based upon the fact that the provider of aba does not hold a license.”257 indeed, in the absence of state licensing, allowing insurers to deny claims based on a lack of state licensure would allow insurers to avoid paying for aba altogether.258 one unique solution gaining popularity is the concept of autism service providers.259 this approach allows states to define the appropriate scope of professionals, licensed or not, who are qualified to provide services to individuals with asd. this ensures not only a certain level of oversight by the state, but also recognizes the importance of having providers who are trained and experienced in the unique challenges associated with treating individuals with asd. indiana, along with other states, lag in recognizing nationally certified aba therapists and would do well to either grant state licensure for aba therapists,260 or to amend the autism insurance mandate to include a category of autism service providers. 4. treatment plans several states require a treatment plan as part of the asd insurance mandates.261 states requiring treatment plans as a condition of coverage should clearly outline who is allowed to develop the plan, who must sign the plan, and the necessary elements. for example, insurers under the indiana mandate were requiring the individual’s primary care physician to sign even though he or she had not participated in the plan’s development, which made these physicians understandably uncomfortable.262 the indiana department of insurance, thus, clarified its guidelines to indicate that the treating physician, rather than the primary care physician, could sign off on the 257. ind. bull. 136, supra note 106, at 2. 258. lisa girion, ruling deals a blow to denials of autism treatment, l.a. times, oct. 27, 2009, http://articles.latimes.com/2009/oct/27/business/fi-autism27. 259. see supra note 152. 260. see, e.g., nev. rev. stat. ann. § 641.172 (lexisnexis 2010). 261. see supra note 153. 262. minutes, supra note 93, at 5. 536 indiana health law review [vol. 8:2 plan. 263 finally, state insurance regulating agencies should collaborate with service providers and insurers to develop model treatment plans to use as templates.264 5. maximum benefit amounts nearly every state mandate limits the maximum benefit amounts.265 using a conservative estimate of $50,000 per year for aba,266 many state limits would cover just over half the cost.267 limiting asd services through maximum benefit amounts means that someone, either parents or the state, is left covering the remaining costs. on the other hand, setting a maximum benefit amount helps control costs and may encourage families and providers to search for more cost-effective ways to deliver services. one unique approach to controlling costs would be to have different maximum yearly benefits based on the type of plan. for example, kentucky sets a higher amount for large group plans than what is required for small group and individual plans.268 6. types of policies covered to fully realize the benefits of insurance coverage for asd treatments, a large number of individuals with asd would have to be in plans covered by the mandate. even in states that have passed asd insurance reform, many individuals are still unable to receive treatment because their health insurance plans are not covered under the mandate.269 in indiana, approximately seventy percent of the families who have health coverage through their employer are on self-funded plans and, thus, not covered by 263. id. 264. model treatment plans would be used not to describe specific treatment goals (as those should be individualized to the person), but to ensure that all the proper information is included in a usable format. 265. see supra note 164. 266. autism speaks, arguments, supra note 4, at 8. see also bunce & wieske, supra note 55, at 2. 267. ariz. rev. stat. ann. §§ 20-826.04(d)(1), (2) (lexisnexis 2010); colo. rev. stat. § 10-16-104(1.4)(b)(i) (2010); conn. gen. stat. § 38a-514b(d) (2010); fla. stat. § 627.6686(4)(b) (2010); 215 ill. comp. stat. ann. 5/356z.14(b) (lexisnexis 2011); iowa code § 514c.26(3) (west 2010); la. rev. stat. ann. § 22:1050(d)(1) (2009); me. rev. stat. ann. 24-a, § 2766(2)(d) (2010); mo. ann. stat. § 376.1224(5) (west 2010); mont. code ann. § 33-22-515(4)(a)(i) (2009); nev. rev. stat. ann. § 689b.0335(2)(a) (lexisnexis 2010); n.j. stat. ann. § 17b:27-46.1ii(1)(c)(3)(a) (west 2009); n.m. stat. ann. § 59a-23-11(b)(2) (lexisnexis 2009); 40 pa. stat. ann. § 764h(b) (west 2009). 268. compare ky. rev. stat. ann. §§ 304.17a-142(2)(a), (b) (west 2010) with ky. rev. stat. ann. § 304.17a-143(2) (west 2010). 269. autism speaks, response, supra note 200. 2011] autism insurance reform: a comparison of state initiatives 537 the mandate.270 nationally, autism speaks estimates that approximately two-thirds of employees of state, local, and tribal governments are enrolled in self-funded health insurance plans.271 given that so many people are covered under self-insured plans, an asd mandate does not lead to providing substantially more people with a given benefit.272 many asd insurance statutes also exclude individual policies or small group plans from their requirements.273 for states to realize fully the long-term benefits of insurance coverage for asd services, laws exempting self-funded, small group or individual plans from mandates would need to change.274 removing exemptions, however, would likely result in significant political backlash and, thus, is not likely a viable solution. still, until mandates cover more individuals with asds, their impact is unlikely to be felt and the bulk of the burden will still fall to state-sponsored services. iv. conclusion in conclusion, asds are complex and costly disorders that cause extraordinary financial hardships to parents and states. current state systems providing treatment for individuals with asds serve too few and suffer from high staff turnover and low quality. it is in society’s best interest to secure early intervention for children with asds to save money on costly, long-term care. improving state-sponsored services is a laudable goal; however, these changes may create an undue financial burden on already starved state budgets. health insurance providers have historically avoided covering treatments for children with autism through various risk-shielding techniques, and consumer protection tools are often not a cost-effective or timely way to secure treatment. while controversial, asd insurance reform is currently the best way to ensure treatment for individuals with asds. however, even liberal mandates, like indiana’s, have problems and cover less than one-third of children with asds.275 there are several ways to address these problems including: eliminating age restrictions; changing diagnostic definitions to include both old and new dsm conceptualizations; allowing flexibility in 270. minutes from the tex. dep’t ins., supra note 93, at 4. 271. autism speaks, response, supra note 200. 272. see jensen & morrisey, supra note 232, at i. 273. see supra notes 181 (small groups exempted) and 187 (individual policies exempted). 274. self-funded plans are generally regulated by erisa (29 u.s.c. §§ 1001) and thus would need to be addressed through those mechanisms. ataa would amend erisa to require self-funded plans to provide coverage. autism treatment acceleration act of 2009 (“ataa”), s. 819, 111th cong. § 12 (2009). 275. autism speaks, response, supra note 200; minutes, supra note 93, at 4 (noting that approximately seventy percent of families are covered by self-funded plans, which are not subject to the asd insurance mandate). 538 indiana health law review [vol. 8:2 the statute for including emerging treatments; granting state licenses to nationally certified aba therapists; developing a model treatment plan with clear guidelines; removing maximum benefit limits; and changing laws to maximize the number of individuals with asds covered under the mandate. it is true that there is no “magic bullet” when it comes to asds. however, at this point, autism insurance mandates are the only weapons we have to help children with asds reach their full potential. stacey a. tovino stacey a. tovino is a research professor at the health law & policy institute at the university of houston law center and a doctoral student in medical humanities at the institute for medical humanities at the university of texas medical branch. professor tovino's research and teaching interests are pri­ marily in the areas of health information privacy; bioethics; research ethics and regulation; literature, medicine, and health law; and the legal history of various aspects of health care in the united states, including midwifery and mental health care. professor tovino is the author of several articles, includ­ ing incorporating literature, literary nonfiction, and illness narratives into a health law curriculum, 9 j. med. & law (forthcoming 2005); american midwifery litigation and legislative preferences for physician-controlled childbirth, 10 cardozo women's l.j. (forthcoming 2005); with william j. winslade, a primer on the law and ethics of treatment, research, and public policy in the context of severe traumatic brain injury, 14 annals health l. 1 (2005); and the use and disclosure of protected health information for research under the hipaa privacy rule, 49 s.d. l. rev. 447 (2004). professor tovino received her law degree from the university ofhouston law center (1997) and her undergraduate degree from tulane university (1994). between 1997 and 2003, stacey worked as an associate attorney in the health industries group at vinson & elkins in houston, texas. hospital chaplaincy under the hip aa prn acy rule: health care or "just visiting the sick"? stacey a. tovino* introduction approximately seventy-nine percent of americans believe that praying can help people recover from illness, injury or disease,1 and nearly seventy­ seven percent of american patients would like spiritual issues discussed as part of their care. 2 despite americans' strong beliefs in the health-related benefits of religious and spiritual practices and traditions, the preamble to the federal department of health and human services' ("hhs "') health information privacy rule (the "privacy rule":f explains that health care "does not include * research professor, health law & policy institute, university of houston law center, houston, texas. doctoral student, institute for the medical humanities, university of texas medical branch; j.d., 1997, university of houston law center; b.a., 1994, tulane university. the author is grateful to harold y. vanderpool, ph.d., th.m., for his comments on an earlier draft, and rev. lerrill white, bcc, for his assistance in understanding the clinical implications of the regulatory interpretations discussed in this article. 1. laurel arthur burton & marcia sue dewolf bosek, when religion may be an ethical issue, 39 j. reugion & health 97 (2000) (citing a poll gallup conducted for cnniusa today); see also professional chaplaincy: its role and importance in healthcare 2 (larry vandecreek & laurel burton eds., 2001) [hereinafter professional chaplaincy] (citing marty kaplan, ambushed by spirituality, time, june 24, 1996, at 62) (citing similar statistics). 2. burton & bosek. supra note 1, at 97. for additional statistics describing americans' beliefs relating to religion, spirituality, and health care, see harold g. koenig et al., handbookofr.:eugion and health 4 (2001) ("in 1994, 96% of the population of the united states believed in god or a higher power, 9()0.4 believed in heaven, 71j0.4 believed in miracles, 73% believed in hell, and 65% believed in the devil" (citation omitted)); professional chaplaincy, supra note l, at ii (discussing a recent meta-analysis of data from forty-two published mortality studies involving approximately 126,000 participants demonstrating that persons who reported frequent religious involvement were significantly more likely to live longer compared to persons who were involved infrequently); paul alexander clark et at., addressing patients' emotional and spiritual needs, 29 joint commission j. quauty & safety 659, 662 (2003) (''71}0.4 of americans believe that faith aids in recovery, and 56% believe that faith has helped them recover; 87% of americans consider religion to be 'very important' or 'somewhat important' in their life" (internal references and citations omitted)); jeffrey s. levin et at., religion and spirituality in medicine: research and education, 278 jama 792 (1997) ("recent surveys reveal that nearly 80% of americans believe in the power of god or prayer to improve the course of illness and nearly 70'.4 of physicians report religious inquiries for counseling on terminal illness .... "(footnotes omitted)); richard p. sloan et at., religion, spirituality, and medicine, 353 lancet664 (1999) ("in a recent poll of 1,000 u.s. adults, 79% of the respondents believed that spiritual faith can help people recover from disease, and 63% believed that physicians should talk to patients about spiritual faith" (quoting tom mcnichol, the new faith in medicine, usa today, apr. 7, 1996, at 4.)). 3. hhs published its first, proposed, version of the privacy rule on november 3, 1999. see standards for privacy oflndividually identifiable health information, 64 fed. reg. 59,918 (nov. 3, 1999) [hereinafter the "1999 proposed rule'']. after receiving and analyzing com52 indiana healtii law review [vol. 2:49 methods of healing that are solely spiritual" (the ''preamble").4 the preamble concludes that, "clergy or other religious practitioners that provide solely religious healing services are not health care providers within the meaning of this rule • . . . "5 some health care attorneys interpret the preamble as prohibiting hos­ pitals and physicians from sharing individually identifiable health information with hospital-employed chaplains.6 on the other hand, many hospital chap­ lains argue that the preamble fails to distinguish between hospital chaplains (who, as members of the health care team, should be entitled to full access to patients' health information), and community clergypersons (who are entitled to receive limited directory information about those patients who have agreed to disclosures of their directory information).7 · ments from the public and the health care industry on the 1999 proposed rule, hhs adopted what was thought to be a final version of the privacy rule on december 28, 2000. see stand­ ards for privacy oflndividually identifiable health information, 65 fed. reg. 82,462 (dec. 28, 2000) [hereinafter the "2000 final rule"). on march 27, 2002, hhs published proposed modifications to the 2000 final rule. see standards for privacy of individually identifiable health information, 67 fed. reg. 14,776 (mar. 27,2002). finally, on august 14,2002, hhs adopted final modifications to its 2000 final rule. see standards for privacy of individually identifiable health information, 67 fed. reg. 53,182 (aug. 14, 2002) [hereinafter the "2002 final modifications!>]. the term "privacy rule" as used throughout this article refers to hhs' 2000 final rule, as amended by hhs' 2002 final modifications, as codified at 45 c.f .r. parts 160 and 164. 4. standards for privacy oflndividually identifiable health information, 65 fed. reg. at 82,568. 5. id. 6. see, e.g., lerrill white, pastoral care providers are members of the healthcare team in accordance with the regulations ofthedepartmentofhealth &human services, apc news, jan./feb.2003, (revised jan. 2005) ("[s]everallaw firms have provided consultation and offered opinions to hospitals and health care systems pertaining to [the privacy rule]. these opinions argue that chaplains or clinically trained pastoral/spiritual care providers are not 'health care providers'"), reprinted in ass'n of prorl chaplains, professional resources, reading room: hip aa and pastoral care, at http://www.professionalchaplains.org/ professional-chaplain-services-resources-reading-room-hippa~5.htm(lastvisitedapr.21,2005) (on file with the indiana health law review); ira j. hadnot, prayers snared: churches fear red tape from new hospital privacy rules, dau.as morning news, jan. 30, 2004, at gl ("yet some lawyers have misinterpreted hip aa and advised hospitals to impose more controls than the law requires, said an official who represents 4,000 chaplains nationwide"). not all health care attorneys interpret the privacy rule as prohibiting hospitals and physicians from sharing individuallyidentifiablehealth information with hospital-employed chaplains. see, e.g., letter from r.g. scott, attorney at law, to .the association ofprofessional chaplains (may 15, 2003) (on file with author) (arguing that "hospital staff chaplains are employees ... of the hospitals where they serve, and they are directly involved in treating patients."); see also jill c. robinson, hip aa: negotiating the secular in the interest of the sacred, vermont ecumenical council & bible soeiety, at http://www.vecbs;orglstatementslhipaa.html (last visited apr. 21, 2005) (on file with the indiana health law review) (noting that, "because it is a federal law, hip aa has been and will be interpreted by the lawyers representing the interests of each institution directly affected by its mandates .... "). 7. see, e.g., lerrill white & rod pierce, hipaa regulations raise questions for chaplains, apc news jan./feb.2002 (noting that "[w]hat is at stake is the institutional definition of who qualifies as a recognized professional health care provider, thus having access 2005] hospital chaplaincy under the hipaa privacy rule 53 this article provides a context for the controversial preamble within the historical relationship between religion and medicine. part i of this article provides relevant background information relating to the privacy rule. part 11 provides an overview of the historical relationship between religion and medicine, introduces the hospital chaplain and discusses the chaplain's educa­ tion, certification, and role in the modern american hospital, and addresses the issue whether hospital chaplains are considered part of the health care team. part ill analyzes the preamble and identifies several arguments that may be used to support a hospital chaplain's access to individually identifiable health information. part iv identifies several approaches for hhs to consider regard­ ing hospital chaplains' access to individually identifiable health information. part iv also concludes that the preamble, perhaps inadvertently, attempts to relegate religious and spiritual practitioners to the limited role of visiting the sick and identifies an almost exclusive role for the medical establishment in the provision of health care and related social and support services. as such, the preamble is the latest chapter in the continually evolving relationship between american medicine and religion. i. introducfion to the hip aa privacy rule hhs' privacy rule, 8 which implements one section of the administra­ tive simplification provisions set forth in the federal health insurance portato appropriate patient information .... j, reprinted in ass'n ofprof"l chaplains, professional resources, reading room: hip aa and pastoral care, at http://www.professionalchaplains .orglprofessional-chaplain-services-resources-reading-room-hippa-l.htm (last visited apr. 21, 2005) (on file with the indiana health law review); lenill white & rod pierce, hipaa regulations' impact on visitation by clergy, lay ministers and fatth group representatives, apc news, may/june 2002, reprinted in ass'n ofprof'l chaplains, professional resources, reading room: hipaa and pastoral care, at http://www.professionalchaplains.org/ professional-chaplain-services-resources-reading-room-hippa-2.htm(lastvisitedapr.21,2005) (on file with the indiana health law review); lerrill white & rod pierce, creating hipaa compliant policies and procedures, apcnews july/ aug. 2002 (arguing that hospitals should formally recognize, in written policies and procedures, chaplains and clinical pastoral education students as health care professionals or as providers of patient treatment), reprinted in ass'n of prof'l chaplains, professional resources, reading room: hip aa and pastoral care, at http://www.professionalchaplains.org/professional-chaplain-serv:ices-resources-reading-room­ hippa-3.htm (last visited apr. 21, 2005) (on file with the indiana health law review). 8. most covered entities were required to comply with the privacy rule by april 14, 2003. small health plans (those health plans with less than five million dollars in annual receipts) had one additional year (i.e., until april 14, 2004) to comply. see 45 c.f.r. § 164.534(b x2) (2005). before the general compliance date for the privacy rule, state hospital licensing laws and state medical·practice acts typically regulated hospitals' and physicians' disclosures of individually identifiable health information. most state hospital licensing laws and medical practice acts contained provisions tbat generally prohibited hospitals and physicians from disclosing confidential patient information without the express written authorization of the patient, unless an exception to the general rule applied. .see, e.g., tex. healtii&safetycodeann. §§ 241.152, 241.153(vernon 2004); tex. occ.codeann. §§ 159.002159.004 (vernon 2004). 54 indiana heal til law review [vol. 2:49 bility and accountability act of 1996 ("hipaa"),9 regulates both uses and disclosures of protected health information10 by certain persons and organiza­ tions that fall within the definition of a covered entity. a. covered entities covered entities generally include all health plans, 11 all health care clearinghouses,12 and certain health care providers13 (i.e., those health care providers who transmit any health information in electronic form in connection with a standard transaction). 14 because most hospitals and physicians elec­ tronically transmit health information to health insurers in connection with claims for reimbursement and other standard transactions, most hospitals and physicians will constitute covered entities to which the. privacy rule applies. thus, most hospitals and physicians, as well as their employees and workforce members (including hospital chaplains), must ensure that their uses and disclosures of protected health information·complywith the privacy rule's use and disclosure requirements.15 · b. protected health information the privacy rule only regulates a covered entity's (and its employees' and workforce members') use or disclosure of certain information that falls 9. health insurance portability and accountability act of 1996, 104 pub. l. 191, 110 stat. 1936,2033 (1996). 10. 45 c.p.r. § 160.103 (2005) (generally defining protected health information as "individually identifiable health information," and excluding from such definition: (i) education records protected by the federal family education rights and privacy act {"ferp a j; (ii) certain student treatment records excepted :from protection by ferp a; and {iii) employment records held by a covered entity in its role as an employer). 11. /d. {defining a health plan as "an individual or group plan that provides, or pays the cost of, medical care (as defined in section 2792{a)(2) of the phs act, 42 u.s.c. § 300gg91{a)(2))''). 12. /d.{definingahealthcareclearinghouseasanentitythatprocesseshealthinformation received from another entity in a nonstandard format into a standard format or receives a standard transaction :from another entity and processes health information into nonstandard format for the receiving entity). 13. /d. {definingahealthcareprovider as a ''providerofservices"undersection 1861(u) of the social security act, a ''provider of medical or health services" under section 1861(s) of the social security act, or any other person or organization who furnishes, bills, or is paid for health care in the normal course ofbusiness). 14. /d. (defining a covered entity as a health plan, a health care clearinghouse, or a health care provider who transmits any health information in electronic form in connection with a standard transaction). the standard transactions fuclude: (1) claims for reimbursement and patient encounter information; (2) payment for health care services and remittance advice; (3) coordination of benefits; (4) health care claim status; (5) enrollment and disenrollment in a health plan; (6) eligibility for a health plan; (7) health p1an·premium payments; (8) referral certification and authorization; (9) first report of injury; and (10) health claims attachments. id. 15. the privacy rule's use and disclosure requirements are set forth at 45 c.p.r. §§ 164.502. 164.504, 164.506, 164.508, 164.510, 164.512, and 164.514 (2005). 2005] hospital chaplaincy under the hipaa privacy rule 55 within the definition of protected health information ( .. phf'). 16 with a few exceptions, the privacy rule generally defines phi as individually identifiable health information.17 working backwards, the second part of this, phrase, health information, is defined as: [a]ny information, whether oral or recorded in any form or medium, that: · (1) is created or received by a health care provider ... ; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.18 health information includes not only medical record and billing record information, but also information relating to the provision of health care to an individual. for example, a hospital's list of current inpatients would constitute health information because the list identifies specific individuals to whom the hospital currently is providing health care.19 16. 45 c.f .r. § 164.500( a)(2005}("except as otherwise provided herein, the standards, requirements, and implementation specifications of this subpart apply to covered entities with respect to protected health information." (emphasis added)). 17. 45 c.f .r. § 160.103 (generally defining protected health information as individually identifiable health infonnation, and excluding from such definition: (i) education records protected by the federal family education rights and privacy act ("ferp a"); (ii) certain student treatment records excepted from protection by ferp a; and (iii) employment records held by a covered entity in its role as an employer). 18. 45 c.p.r.§ 160.103. 19. in the first-ever criminal conviction for a violation of the privacy rule, the united states attorney's office interpreted the definition ofindividuallyidentifiablehealth infonnation to include demographic information relating to patients of a covered entity, even if such demographic infonnation does not include any specific information about the health of the patient or does not identify the health or medical services provided to the patient. see plea agreement at 5, united states v. gibson, no. cr04-0374rfm (w.o. wash. aug. 19, 2004), available at http://world.std.com/-goldberwhlpaacrimesplea.pdf(lastvisitedapr. 21, 2005) (on file with the indiana health law review). in october of2003, defendant gibson was employed by the seattle cancer care alliance, a covered health care provider required to comply with the privacy rule. sometime during the month of october, gibson obtained the name, date ofbirth, and social security number of a patient who was undergoing treatment for a rare and often fatal form of cancer at the seattle cancer care alliance. ld. during october and november of2003, and january of 2004, gibson inappropriately used and disclosed by telephone the name, date of birth, and social security number of the patient to at&t universal card, first usa visa, chase manhattan bank, and fleet credit card services for purposes of obtaining credit cards in the cancer patient's name. id. gibson used the credit cards to obtain cash advances and to purchase various items including video games, home improvement supplies, apparel, jewelry, porcelain figures, groceries, and gasoline. id. the total value of the debt gibson incurred was $9,139.42. id. on august 18, 2004, the united states attorney's office filed a one-count charge in the united states district court for the western district of washington stating that gibson "knowingly and for a reason other than permitted by [hip aa] disclosed individually identifiable health information of[a patient], with intent to use that infonnation for personal gain." id. the following day, gibson waived his right to be charged by indictment and plead 56 indiana health law review [vol. 2:49 health information must be individually identifiable to constitute phi. health information is individually identifiable when: ( 1) it identifies the individual who is the subject of the information (e.g., because the information includes the patient's name or other direct identifiers); or (2) there is a rea­ sonable basis to believe the information could be used to identify the indivi­ dual who is the subject of the information. 20 although the privacy rule does not specifically list those identifiers the inclusion of which would establish a reasonable basis to believe that the information could be used to identify the individual, the privacy rule does not apply to information that has been appropriately de-identified. 21 the privacy rule establishes two methods for de-identifying health information. the most popular method. known as the safe harbor method, 22 provides that a covered entity is considered to have de-identified information if the covered entity removes eighteen enumerated identifiers23 from the inforguilty. /d. the plea agreement indicates that the u.s. attorney did not require the defendant to have disclosed specific information relating to the patient's past, present, or future physical or mental condition or specific information identifying the types of health care provided to the patient in order to establish a violation of the privacy rule. gibson's inappropriate use and disclosure of'~ust" the patient's name, date of birth, and social security number was sufficient to establish a violation of the privacy rule. see id. 20. 45 c.p.r. § 160.103 (definition of individually identifiable health information). 21. the privacy rule's provisions relating to de-identification are set forth at 45 c.p.r. §§ 164.502(d) and 164.514(a)-(c) (2005). 22. the second method for de-identifying information requires a person with appropriate knowledge of, and experience with, generally accepted statistical and scientific principles and methods for rendering information not individually identifiable to apply such principles and methods and determine that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information. the person with knowledge of and experience with the statistical and scientific principles must document the methods and the results ofhis or her analysis that justify the determination that the risk of identification is small. 45 c.p.r.§ 164.514(b}(l)(i), (ii). 23. the following identifiers of the individual (or of relatives, employers, or household members of the individual) must be removed from the information for the information to be de­ identified under the safe harbor method: (1) names; (2) all geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the bureau of the census: (a) the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (b) the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000; (3) all elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; ( 4) telephone numbers; (5) fax numbers; ( 6) electronic mail addresses; (7) social security numbers; (8) medical record numbers; (9) health plan beneficiary numbers; (1 0) account numbers; ( 11) certificate/license numbers; (12) vehicle identifiers and serial numbers, including license plate numbers; (13) device identifiers and serial numbers; (14) web universal resource locators (urls); (15) internet protocol (ip) address numbers; ( 16) biometric identifiers, including finger and voice prints; (17) full face photographic images and any comparable images; and (18) any other unique identifying number, ch~cteristic, or code. 45 c.p.r.§ 164.514(b)(2)(i). 2005] hospital chaplaincy under the hip aa privacy rule 51 mation and has no actual knowledge that the remaining information could be used alone or in combination with other information to identify the subject of the information. 24 once information has been de-identified, a covered entity may freely use or disclose the information without regulation by the privacy rule. however, many covered entities believe that completely de-identifying information renders it essentially useless.25 the privacy rule generally protects pill regardless of whether the patient who is the subject of the information is dead or alive?6 in addition, the privacy rule protects pill regardless of whether it is written (e.g., a computer generated list of patients or a hand-written progress note), orally spoken (e.g., an ethics committee discussion or a telephone conversation relating to a particular patient), or visibly displayed (e.g .• an electronic medical record tliat is displayed on a computer screen).27 this lengthy discussion ofpill is necessary to understand the many ways in which hospital chaplains may access or use pill. among numerous other activities, hospital chaplains access or use pill when they: (1) respond to a physician's order or nurse's referral to provide religious or spiritual care to a particular patient; (2) participate in an ethics committee discussion about a par­ ticular patient; (3) access a list of newly admitted inpatients to locate the room number of a particular patient requesting religious or spiritual care; ( 4) prepare paperwork relating to a patient who has just passed away; (5) coordinate funeral arrangements; (6) refer a patient to a patient advocate, a social worker, or another health care provider for additional social or health services; (8) 24. 45 c.f.r. § 164.514(bx2). 25. see, e.g., jennifer kulynych & david k.om, the new federal medical-privacy rule, 347n.eng.j.med.ll33, 1134(2002)(arguingtbattheprivacyrule'sstrictde-identification requirements will complicate hospitals' current practices of releasing information to medical researchers). 26. however, the privacy rule does identify a few situations in which phi about decedentsmaybeusedordisclosedwithoutthedecedent's(orapersonalrepresentative's)prior written authorization. see, e.g., 45 c.f.r. § 164.512(f)(4) (2005) (noting that "[a] covered entity may disclose protected health information about an individual who has died to a law enforcement official for the purpose of alerting law enforcement of the death of the individual if the covered entity has a suspicion that such death may have resulted ftom criminal conduct."); 45 c.f .r. § 164.512(g) (addressing disclosures ofphi relating to decedents by covered entities to coroners, medical examiners, and funeral directors); 45 c.f.r. § l64.512(i) (addressing disclosures to researchers engaging in research using decedents' information). other than these limited situations, the privacy rule generally protects phi relating to living and deceased persons equally. see standards for privacy oflndividually identifiable health information, 65 fed. reg. 82,462, 82,632 (dec. 28, 2000) (''[qovered entities must under this rule protect the protected health information about a deceased individual in the same manner and to the same extent as required for the protected health information of living individuals."). 27. 45 c.p.r. § 160.103 (2005) (defining "health information" as "any information, whether oral or recorded in any form or medium ..• "); see also standards for privacy of individually identifiable health information 65 fed. reg. 82,462. 82,620 (dec. 28, 2000) ("covering oral communications is an important part ofkeeping individually identifiable health information private. if the final rule were not to cover oral communications, a conversation about a person's protected health information could be shared with anyone."). 58 indiana health law review [vol. 2:49 discuss a patient's spiritual needs with another member of the clergy who may be familiar with the patient; and (9) access a patient's record in order to chart the religious or spiritual care services provided to the patient. hospital chaplains routinely access and use phi in the course of their job duties. c. uses and disclosures the privacy rule regulates both internal uses28 of phi, including uses of phi by a covered entity's employees and workforce members, as well as external disclosures29 of phi, including disclosures of phi by the covered entity to other persons and organizations who are not employees or workforce members of the covered. entity.30 although members of the public who commented on hhs' 1999· proposed rule recommended that covered entities have fewer requirements for internal uses of phi than for disclosures, hhs disagreed.31 thus, if a covered hospital wishes to disclose phi to a community clergyperson who is not employed by the hospital, such as a priest at a local church, the disclosure of phi by the hospital to the priest must be made in accordance with the use and disclosure requirements set forth in the privacy rule, as discussed in part iii.a, below. likewise, if a hospital-employed chaplain wishes to use phi maintained by the covered hospital to carry out his or her job duties, the internal use of the information by the employed chaplain also must be made in accordance with the use and disclosure requirements set forth in the privacy rule. 28. 45c.f.r. § 160.103(definingusetomean, "withrespecttoindividuallyidentifiable health information. the sharing, employment, application, utilization, examination. or analysis of such information within an entity that maintains such information.''). 29. /d. (defining disclose to mean "the release, transfer, provision of access to, or diwlging in any other manner of information outside the entity holding the information."). 30. the application of the privacy rule to both uses and disclosures ofhealth information is different than many state laws, which typically regulate health care providers' disclosures of information to a third party, but not the providers' internal uses of the same information. for example, the texas hospital licensing law and the texas medical practice act only regulate disclosures ofhealthinformation by texas hospitals and physicians, respectively, but not their internal use of information. tex. realm & safely code ann. § 241.152(a) (vernon 2004) ("except as authorized by section 241.153, a hospital or an agent or employee of a hospital may not disclose health care information about a patient to any person • . . without the written authorization of the patient .... ") (emphasis added); tex. occ. code ann.§ 159.002(a),(b) (vernon 2004) ("a record of the identity, diagnosis, evaluation, or treatment of a patient by a physician that is created or maintained by a physician is confidential and privileged and may not be disclosed except as provided by this chapter") (emphasis added). 31. for example, in the context of research, hhs explained that [w]e disagree that an individual's privacy interest is of less concern when covered entities use protected health information for research purposes than when covered entities disclose protected health information for research pur­ poses. therefore, in the final rule, the research-related requirements ... apply to both uses and disclosures of protected health information .... standards for privacy of individually identifiable health information. 65 fed. reg. at 82,702. 2005] hospital chaplaincy under 1he hipaa privacy rule 59 d. religion, medicine, and hospital chaplaincy before addressing the issue whether the privacy rule permits hospital chaplains to access phi beyond directory information, this part n provides an overview of the historical relationship between religion and medicine and discusses the role of the chaplain in the modern american hospital. a. the relationship between religion and medicine2 1. the western christian tradition in ancient and medieval times, medicine and religion exhibited a close relationship as evidenced by healing rites, exorcisms, pilgrimages, health cults,33 and the fact that many medieval hospitals were conducted by religious orders.34 until well into the renaissance, spiritual care and medical care frequently were dispensed by the ·same person,35 and priests and physicians often were considered "one and the same."36 in the middle ages, the church was the official body that issued medical licenses to physicians who, typically, were monks or priests, and the church primarily provided care for the poor and the sick.37 the hospital of the middle ages was a "religious house in which 32. for a detailed discussion o~ and timeline relating to, the history of religion, science, and medicine, see koenig et al., supra note 2, at 24-49. 33. rodney j. hunter, pastoral care and healthcare chaplaincy, in 4 encyclopedia ofbioetidcs 1975, at 1978 (stephen g. posted., 3rd ed. 2004). 34. paulstarr, the social transformationofa.mmucanmedicine 149(1982). 35. see, e.g., wiujam f. may, the physician's covenant: images of the healer inmedicalenncs 26 (1983) (noting that the ancient shaman "often combined three functions: curing the sick, directing communal sacrifice, and escorting the dead to the other world. he combined, in effect, three offices that have been separated in modern times: physician, priest, and undertaker."); ronald l. numbers & ronald c. sawyer, medicine and christianity in the modern world, in healm!medicineandthef aithtraditions: aninquir.yinto religion and medicine 140 (martin e. marty & kenneth l. vaux eds., 1982) (noting that "so complimentary were the roles of physician and priest that throughout much of the middle ages clerics often provided medical care, even though the ministerial and medical professions were formally distinct"); sloan et al., supra note 2, at 664 (noting that," at various times worldwide, medical and spiritual care was dispensed by the same person."). 36. see, e.g., daniel w. foster, religion and medicine: the physician's perspective, in healmimediclne and the faith traditions: an inquiry into reugion and medicine 245,250 (martin e. marty & kenneth l. vaux eds., 1982) (noting that "for centuries the capacity for healing was considered vested in those with divine power; priest and physician were one and the same.''); sloan et al., supra note 2, at 664; koenig et al, supra note 2, at 35 (notingthat, "[u]ntilwellintotherenaissance(theperiodbetweenthemiddleagesandmodern times), the doctor is generally also a priest.''). 37. koenig et al, supra note 2, at 34 (citing darrel w. amundsen, the medieval catholic tradition, in caiung and cur.ing: health and medicine in the western reugious traditions 83(ronald l. numbers & darrel w. amundsen eds., 1998)). 60 indiana health law r.evmw [vol. 2:49 the nursing personnel had united as a vocational community under a religious rule."38 the eventual segregation of preaching and healing resulted from a variety of factors. 39 during the middle ages. the roman catholic church did not formally forbid the practice of medicine by clergy generally; however, the church did question the appropriateness of clergypersons engaging in medical practice.40 during the late middle ages and into the renaissance, guilds of physicians, surgeons, and apothecaries sought legal monopolies over the healing arts. 41 when successful, their efforts excluded clergypersons as well as charlatans from practicing medicine.42 by the year 1500, only three of the twenty-three members of the faculty of medicine at paris were clergypersons.43 despite the efforts of the medical profession and the church to dis­ courage clergypersons from practicing medicine, cleric-physicians. persisted in part because the medical guilds had been unable to enforce their monopolies in rural areas "and necessity forced some priests to minister to their flocks.'""' in addition, appropriately credentialed physicians were not always easy to locate and, when they were, their fees sometimes were prohibitive.45 thus, some clergy and other irregular healers continued to practice medicine in small towns and in rural areas into the eighteenth and nineteenth centuries. 46 beginning with the protestant reformation, christian ministry began to withdraw· its involvement in healing and from making scientific, empirical claims regarding the natural world. 47 the result was an intellectual and pro­ fessional division between religion and medicine.48 as medicine grew more scientific and ministry became confined to matters of god and the soul, · corresponding professional domains were identified. physicians became responsible for the scientific care of the physical body while members of the clergy became responsible for the spiritual care of the soul.49 medical science began to assign mental and emotional disorders, traditionally considered problems of the soul, to the physical body, and regarded such disorders as potentially treatable by medical means. 50 38. starr, supra note 34, at 149 (quoting george rosen, the hospital: historical sociology of a community institution, in 'dmhospitalinmodbrnsociety 10 (eliotfreidson ed., 1963)). · 39. numbers & sawyer, supra note 35, at 140. 40. /d. 41. id. 42. id. 43. id. 44. id. 45. numbers & sawyer, supra note 35, at 140. 46. /d. 47. hunter, supra note 33, at 1978. 48. id. 49. id. 50. id. 2005] hospital chaplaincy under the hip aa privacy rule 61 however, some of the distinctions that had been drawn between the scientific care of the physical body and the spiritual care of the soul began to blur with the development of psychiatry and the religion and health movement in the early twentieth century.51 psychoanalysis and related developments identified psychogenic factors that played a role in many psychiatric disorders, and empirical studies in psychosomatic medicine revealed the important effects of emotional and spiritual attitudes on physical health and healing. 52 at the same time, theology began to recover biblical "wholistic" conceptions of human personhood, salvation, and the healing potential of religious ministry. 53 in this theology the welfare of the whole person, physical, mental, and spiritual, was regarded as a profound unity. the result was a gradual closing of the theoretical gap between medicine and religion and the emergence of a more collaborative style of work between physicians and pastoral caregivers. 54 2. the american relationship in colonial america (1603-1787), the close relationship between religion and medicine existed as it had in the middle ages. although medicine in seventeenth and eighteenth century america focused on a rational understand­ ing of the human body and the world of nature, "religious perspectives were consciously and regularly viewed as compatible with and at points augmen­ tative of such knowledge."55 for example, self-help and other similar litera­ ture addressing medical treatments identified a combination of natural and religious understandings. 56 moreover, many members of the clergy served as physicians. 57 heinrich melchior muhlenberg, one of the founders of american lutheranism, undertook a healing ministry in colonial america in part because "doctors [were] few and far between."58 in addition, prospective american ministers frequently studied medicine during their theological instruction in order to provide a better foundation for the provision of medical services in rural or missionary settings. 59 in the colonial period, "medical theory and therapy could be readily learned," and the average person who used the title 51. id. 52. /d. 53. hunter, supra note 33, at 1978. 54. id 55. harold y. vanderpool, medicine and medical ethics, in 2 encyclopedia of the american reugious experience 1253, 1254 (charles h lippy & peter w. williams eds., 1988). 56. id. 57. id at 1255; see also numbers & sawyer, supra note 35, at 141 ("in colonial new england, puritan cleric-physicians provided a significant part of the medical services, especially outside boston and the larger towns."). 58. numbers & sawyer, supra note 35, at 141. 59. vanderpool, supra note 55, at 1255. 62 indiana health law review [vol. 2:49 "doctor" had read a few books on medicine and served as an apprentice to a practicing physician for several months or more.60 duringamerica'sfirstcentury(1787-1890),secularbeliefsincreasingly served as the foundation for medical theory and practice. 61 regular practi­ tioners, including those who were educated in anatomy, botany, chemistry, and surgery, relied upon natural explanations and therapies in their practices. they also organized themselves into state medical societies, taught their theories in america's new medical schools, and officially opposed irregular practitioners whose various sects and groups were at odds with traditional theory and practice. 62 in part due to the opposition between regular and irregular practi­ tioners, 63 individuals who were both ministers and physicians "withdrew from and were partly squeezed out of medical practice" by the early decades of the nineteenth century.64 following the civil war, some individuals believed that american medicine and religion conflicted at a fundamentallevel.65 the new sciences of geology, evolutionary biology, psychology, and scientific historiography "question[ ed] fundamental biblical assumptions regarding human origins and development, the historical and scientific accuracy of the bible, and traditional views regarding the nature of the human psyche. •>66 when diseases were assigned to specific natural causes, religious explanations became "almost superfluous.'>67 for example, the american response to cholera in 1832 and 1849 was largely religious because the cause of the disease was unknown at that time.68 however, when the cause of the disease was discovered in 1866, religious explanations faded away.69 perhaps as a reaction against conventional medical theories, nineteenth century america witnessed the development of several irregular theories of medicine including, but certainly not limited to, the thomsonians' heat­ restoring botanicals, health food campaigns, and hydropathy. 70 joseph smith's 60. id. 61. id. at 1257. 62. id. 63. see, e.g., major problems in the history of american medicine and pubuc health 55 (john harley warner & janet a. tighe eds., 2001) (distinguishing "regular bred physicians" or ''regulars" from ''non-regular" practitioners). 64. vanderpool, supra note 55, at 1257. 65. id. 66. id. 67. numbers & sawyer, supra note 35, at 139. 68. id. ("as long as cholera remained a mystery, religious persons felt ftee to regard it as a miracle, 'a scourge, a rod in the hand of god. 'j (emphasis in original). 69. id. (''when cholera threatened to return in 1866, americans devoted their energies to improving sanitation rather than to discussing the theological meaning of the event.''). 70. vanderpool, supra note 55, at 1258. thomsonians were followers of samuel thomson, a botanic healer who decried the regular medical profession as a murderous mono­ poly. see, e.g., samuel thomson, new guide to health; or, botanic f amh..y physician (1835). thomsonianism was the first organized anti-orthodox system of medical belief and practice. major problems in the history of american medicine and pubuc health, supra note 63, at 51. 2005] hospital chaplaincy under tile hipaa prnacy rule 63 botanical remedies, his opposition to tea, coffee, alcoholic beverages, and tobacco, and his emphasis on spiritual healing flourished in frontier settlement areas.71 relative to irregular practitioners, the status of regular physicians improved after the reinstatement of several states' medical licensure laws in the 1870's, the use of anesthesia and antisepsis in the 1880s, the beginning of clinical and laboratory research in 1890, the development and use of vaccines, antitoxins, and x -rays in the 1890s, and the building of more than three thousand new hospitals in the thirty-eight year period from 1872 to 1910.72 by 1890, american religion and medicine were widely considered to be operating in separate realms/3 and physicians eventually "came to control medical care as off limits to the clergy."74 in the second-half of the nineteenth century and the first-half of the twentieth century, american patients continued, however, to choose their physicians based on subjective and personal judgments that allowed for simi­ larities in religion, ethnic group, and socioeconomic background.75 for example, catholic immigrants tended to select catholic physicians and jewish immigrants tended to select jewish physicians. 76 during this time period, many american patients also chose their hospitals by religious or ethnic sponsorship.77 in 1849, new york catholics founded st. vincent's hospital and, a few years later, new york episcopals founded st. luke's. 78 new york jews established mt. sinai hospital in 1852, and the catholics opened their second hospital, st. francis, in 1865.79 by 1885, catholics had established 154 hospitals throughout the united states, more than the total number ofhospitals 71. vanderpool, supra note 55, at 1258-59. 72. /d. at 1259-60. 73. id. at 1253. 74. /d. at 1256 (discussing william douglass' defense of medicine's separate professional status as ''prophetic of the way doctors eventually came to control medical care as off limits to the clergy."). 75. david j. rothman, strangers at tim bedside: a history of how law and bioetiucs transformed medical decision making 111 (2nd ed., walter de gruyter 2003) (1991). 76. /d. at 111 (''in an era when major eastern and midwestern cities were divided into ghetto enclaves, immigrants tended to select their doctors along ethnic and religious lines. catholics turned to catholic doctors, jews to jewish doctors •... "). 77. id. at 123; see also starr, supra note 34, at 174 (noting that ethnic and religious hospitals furnished opportunities for internships and residencies that jewish, catholic, and black doctors were denied elsewhere and staff appointments so that they could attend patients of theirs needing hospitalization); rosemary stevens, in sickness and in wealth: american hospitals in tim twentieth centijry 24 ( 1989) ("religious, ethnic, and linguistic diversity in the united states made schools and hospitals visible affirmations of the importance of immigrants and religious groups."). 78. charles e. rosenberg, 1iie care of strangers: 1iie rise of america's hospital system 109 (1987). 79. ld.; see also starr, supra note 34, at 153-54 ("in new york city, according to a historian ofits jewish community, jews' hospital (later mt sinai) developed within a few years after its founding into 'the most important jewish organization in the city.'"). 64 indiana health law review [vol. 2:49 that existed in the united states in the late 1860s.80 by 1930, approximately 640 catholic hospitals were established in the united states, and the catholic hospital association c'cha") estimated that one catholic hospital bed was available for every 231.2 american catholics. 81 social and medical historians emphasize the regularity with which members of religious communities built and frequented their own hospitals during the early part of the twentieth century: in new york city from 1925 to 1945, 60 percent of the fifty-eight general hospitals had religious sponsorship (most of them catholic or jewish); moving westward (where one might have imagined the ethnic impact to be lower), cincinnati in 1925 had nine general hospitals, of which four were sponsored by protestant groups (chiefly methodists), two by catholics, and one by jews. that year, 308 catholic patients in cincinnati had to enter a hospital, and 165 of them (54 percent) chose one of the three catholic hospitals; so too, 54 of the 71 jewish patients (76 percent) entered the jewish hospital. (among protestants, the figures were lower, for those in the majority did not experience the same incentives.) to be sure, catholic and jewish hospitals served more than catholic and jewish patients-the cha estimated that 49 percent of its patients were non-catholic-and not every member of an ethic or religious group patronized the group's own hospitals. but a majority of catholics did use the group's hospitals, and the figures may even have been slightly higher among jews. 82 early twentieth-century catholic hospitals emphasized the human and spiritual, as well as medical, needs of their patients.83 "nursing sisters" com­ forted patients and ensured that priests were available to give extreme unction to catholic patients.84 the walls of catholic hospitals frequently displayed crucifixes and paintings that displayed "the deepest catholic piety."85 and 80. rosenberg, supra note 78, at ill. 81. rothman, supra note 75, at 123. 82. jd. at 123-24; see also stevens, supra note 77, at 23 (noting that more than eighty percent of the private and sectarian charitable hospitals existing in 1910 were established after 1880, and that thirty-two percent were established in the decade beginning in 1900); id. at 29 (noting that "illinois reported the largest cluster of roman catholic hospitals of any state in 1903 (43 out of a total of 118 hospitals)."). 83. rothman, supra note 75, at 124; see also rosenberg, supra note 78, at 240 ("to be treated by a religious woman and to pay a modest sum for one's room and board transformed a hospital stay for catholics into something less painful and humiliating than it would have in a large, nonsectarian-that is, protestant-voluntary hospital."). 84. rothman, supra note 75, at 124. 85. jd. at 124. 2005] hospital chaplaincy under the hip aa privacy rule 65 catholic physicians believed that prescribing medications for patients but ignoring the human and spiritual aspect of patient care was not an effective method of treatment. 86 jewish hospitals demonstrated a similar religious orien­ tation. one of the stated reasons for the 1900 founding of beth israel hospital on new york's lower east side was to "have a hospital that should be con­ ducted on strictly orthodox principles in its kitchen as well as in other respects."87 jewish patients who received treatments at jewish hospitals also could be assured of receiving kosher foods and access to yiddish-speaking physicians. 88 after the 1950s, however, sectarian hospitals discontinued their exclu­ sive reliance on religion or ethnicity as a reason for selecting resident and attending physicians and began to place greater weight on the area of speciali­ zation or expertise as well as the merit of the physician:89 "it became increas­ ingly difficult to define what was presbyterian about presbyterian hospital or jewish about mt. sinai hospital, and the answer could not be found in the characteristics of either the patients or the attending physicians.'>90 although catholic hospitals are somewhat excepted from this trend, social and medical historians argue that catholic hospitals of the second-half of the twentieth century "barely resembled" their predecessor hospitals of the early twentieth century.91 similarly, the trustees of montefiore hospital in new york amended their charter in 1985 to eliminate the requirement that a majority of the board of trustees had to be jewish.92 very broadly, one might conclude that in the western christian tradition, medicine and religion: (1) enjoyed a close relationship in ancient and medieval times through healing rites, exorcisms, pilgrimages, and health care cults; (2) began to separate during (and did separate following) the protestant refor­ mation and the turn of the seventeenth century with the rise of modem science and scientific medicine; and (3) grew closer together again with the develop­ ment of dynamic psychiatry and the religion and health movement in the early 86. !d. at 124-25. 87. !d. at 125. 88. !d. at 125; see also rosenberg, supra note 78, at 178 ("german-speaking physicians whether jewish or christian might find attending positions in german and jewish hospitals."); starr, supra note 34, at 173 ("discrimination was a principal reason for the formation of separate religious and ethnic hospitals .... catholics were afraid they might not be given last rites, and jews feared they would have to eat nonkosher food and face ridicule for their appearance and rituals."). 89. rothman, supra note 75, at 129-30. 90. !d. at 130. 91. !d. at 130; see also stevens, supra note 77, at 26 (''hence the survival of names such as presbyterian, methodist, baptist, or mount sinai for hospitals which today are indistinguishable from nonsectarian institutions."). 92. rothman, supra note 75, at 130; see also stevens, supra note 77, at 100 ("world war i confirmed that the united states was now one nation .... local elites on boards of trustees continued to represent business and religious interests, but the old ethnic, religious, and national identifies of hospitals had blurred."). 66 indiana health law review [vol. 2:49 twentieth century. in the united states, medicine and religion shared a con­ stantly evolving and interwoven relationship seemingly characterized by action and reaction, participation and withdrawal, competition and cooperation. de­ pending on when asked, one might describe american medicine and religion as incompatible, complimentary,93 or even augmentative,94 or as enemies or allies.95 b. the history of clinical pastoral education and american hospital chaplaincy when a hospital or other health care facility employs, contracts with, sponsors, or otherwise affiliates with a minister, priest, pastor, rabbi, or other similar person to provide pastoral care96 or religious or spiritual services in its facility, the provision of such care or services by that person generally is known as "health-care chaplaincy.'m to simplify matters, this article will refer to, and use as an example, chaplains who provide pastoral care in hos­ pitals (hereinafter, "hospital chaplains"). please note, however, that the legal principles discussed in this article would apply equally to persons who pro­ vide pastoral care or religious or spiritual services in or through other types of health care organizations that constitute covered entities under the privacy rule, including nursing facilities, hospices, and home health agencies. 98 93. see, e.g., numbers & sawyer, supra note 35, at 140(notingthattherolesofphysician and priest throughout the middle ages were "complimentary''). 94. see, e.g., vanderpool, supra note 55, at 1254 (stating that medicine and therapy in seventeenth and eighteenth century america were viewed as "compatible with and at points augmentative"). 95. see, e.g., numbers & sawyer, supra note 35, at 134 (asking whether church and medicine are "enemies or allies''). 96. from a christian perspective, the phrase pastoral care means "the attempt to help others, through words, acts, and relationships, to experience as fully as possible the reality of god's presence and love in their lives." hospital ministry: the role of the chaplain today 46 (lawrence e. holst ed., 1985). today, the phrase generally refers to the services provided by ordained ministers, priests, and other persons with designated religious roles, including deacons and members of roman catholic religious orders, to persons in need. although the phrase primarily has christian roots, other faith traditions, including judaism, sometimes used the phrase analogously. hunter, supra note 33, at 1975. 97. hunter, supra note 33, at 1975. 98. see 45 c.f .r. § 160.103 (2005)( defining a health care provider to include "a provider of services (as defined in section 186l(u) ofthe [social security] act, 42 u.s.c. 1395x(u))"); 42 u.s.c. § 1395x(u) (2005) (defining a provider of services to include a skilled nursing facility, home health agency, or hospice program, among other types of health care providers). professional chaplains provide pastoral care and religious and spiritual services in a variety of healthcare settings including, but not limited to, facilities providing acute care, long-term care, assisted living, rehabilitation, mental health services, outpatient services, addiction treatment, care and services for mental retardation and developmental disability, and hospice and palliative care. see professional chaplaincy, supra note 1, at 5 (describing the healthcare settings for spiritual care). 2005] hospital chaplaincy under the hip aa privacy rule 67 late nineteenth and early twentieth century hospital chaplain services frequently were provided by retired, community clergypersons who had no special training beyond the experience gained from their local parishes. 99 however, in the early part of the twentieth century, the "religion and health movement" began to explore the positive relationship between religion and modern medicine and proposed the placement of theological students in clinical settings. 100 in 1923, dr. william s. keller placed theological students in a general hospital in cincinnati and, in 1925, congregational minister anton t. boisen developed a program at worcester state hospital in massachusetts that studied the relationship between religion and mental disorders. 101 boisen's program, which later became known as "clinical pastoral education,"102 grew out of his dissatisfaction with traditional theological education of the day, ''which was considered by many to be too abstract, too removed from life, too divorced from the practical tasks ofministry."103 boisen believed that intensive clinical experience, not books, was the key to developing a theological understanding of human nature and effective pastoral care. 104 the clinical pastoral education movement peaked in the 1930s with the development of clinical pastoral training centers, the certification of chaplain supervisors, and the creation of staff chaplaincy positions in both mental and general hospitals, many of which still exist today. 105 c. education and certification of hospital chaplains most oftoday's hospital chaplains hold college and seminary degrees or have other appropriate theological education, usually with an emphasis in biblical theology, dogmatics, church history, philosophy, or the arts and humanities. 106 most hospital chaplains also have been ordained, commis­ sioned, or otherwise endorsed by their religious denominations. 107 state law typically does not license hospital chaplains, although some hospital chaplains 99. hunter, supra note 33, at 1977. 100. /d. (citing e. brooks hojjfield, a history of pastoral care in america: from salvation to self-realization (1985)). 101. /d. (citing edward e. thornton, professional education for ministry: a history of cunicalpastoraleducation (1970)); see also lawrence e. holst, hospital chaplain between worlds, in health/medicine and the faith traditions: an inquiry into religion and medicine 293,297 (marin e. marty & kenneth l. vaux, eds., 1982) (explaining that clinical pastoral education began in 1925 in a state mental hospital in worcester, massachusetts). 102. hunter, supra note 33, at 1977. 103. holst, supra note 101, at 297. 104. hunter, supra note 33, at 1977 (citing anton t. boisen, the exploration of the inner world (1971)). 105. id. 106. holst, supra note 101, at 297. 107. hunter, supra note 33, at 1977. 68 indiana health law review [vol. 2:49 who also practice specialized pastoral counseling are licensed under state law as pastoral counselors, psychologists, or marriage and family therapists.108 in addition to formal theological education, nearly all full-time profes­ sional hospital chaplains have trained for their ministries through participation in some level of clinical pastoral education ("cpe"). in the united states, the association for clinical pastoral education ("acpe"), the national associa­ tion of catholic chaplains, and the national association of jewish chaplains establish high standards for the professional practice of hospital chaplaincy and enforce such standards through rigorous certification and review proce­ dures.109 the acpe generally accredits three different levels of cpe for: (1) interns and beginning residents; (2) residents preparing for chaplaincy certifi­ cation and residents seeking specialization in a particular clinical area; and (3) individuals training and preparing to be certified as cpe supervisors. no interns generally are defined as those individuals who participate in one or two units ofcpe. 111 each unit ofcpe includes approximately 400 hours of super­ vised education in a health care or institutional setting. 112 residents generally are defined as those individuals who participate in one or two years of a full­ time cpe program. 113 each year includes approximately 1,600 hours of super­ vised education in a health care or institutional setting. 114 the acpe requires individuals to complete i ,600 hours of cpe to become a board-certified chaplain. 115 individuals who want to obtain a specialization in hospice, pedia­ trics, cardiology, rehabilitation, or neurology chaplaincy can do so by com­ pleting additional cpe in the relevant setting. 116 to be eligible to enter training to become a cpe supervisor, an indivi­ dual must have completed at least four units, or 1,600 hours, ofcpe. upon completion of supervisory training, the individual is eligible to be certified by the acpe as a cpe supervisor. cpe supervisors are permitted to develop and conduct cpe training for all acpe-accredited programs. 108. id. 109. id. 110. certification commission, ass'n for clinical pastoral educ., acpe certification manual 5 (2005), available at http://www.acpe.edu/acroread/ 2005 _certification_ manual. pdf. 111. medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2004 rates, 68 fed. reg. 45,346,45,425 (aug. i, 2003). individuals also may undertake one or more units of cpe to be ordained into professional ministry or to obtain a doctoral degree with a specialty in pastoral counseling or related fields. id. 112. id. 113. medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2004 rates, 68 fed. reg. at 45,425. 114. !d. 115. jd. 116. jd. 2005] hospital chaplaincy under the hip aa prn acy rule 69 d. the functions and job duties of today 's hospital chaplain as part of their job duties, hospital chaplains interact with patients and families, medical and nursing staff members, ethics committee and institu­ tional review board members, hospital administrators, volunteers, and com­ munity members. hospital chaplains perform many functions and services that are partly or mostly religious or spiritual in nature as well as several other functions and services that cannot be characterized solely by their religious or spiritual characteristics. 117 the functions and services oftoday's hospital chaplain that are partly or mostly religious or spiritual in nature include, but certainly are not limited to: providing spiritual care, including grief and loss care; performing spiritual assessments of patients; performing patient risk screenings, which includes identifying those patients whose religious or spiritual conflicts may com­ promise recovery or satisfactory adjustment; charting spiritual care interven­ tions in medical records; protecting patients from unwelcome forms of spiritual intrusion; reminding hospital workforce members and patients of the healing power of religious faith; facilitating spiritual issues relating to organ and tissue donation; designing and leading religious ceremonies of worship and ritual including prayer, meditation, reading of holy texts, worship and observance of holy days, blessings and sacraments, memorial services and funerals, rituals at the time of birth or other significant times of life-cycle transition, and holiday observances; making presentations concerning spiritu­ ality and health issues; training and supervising volunteers from religious com­ munities who can provide spiritual care to the sick; conducting professional clinical education programs for seminarians, clergypersons, and religious leaders; developing congregational health ministries; educating students in the health care professions regarding the interface of religion and spirituality with medical care; offering patients, family members, and staff an emotionally and spiritually "safe" professional from whom they can seek counsel or guidance; engaging in research activities relating to the development of spiritual assess­ ment and spiritual risk screening tools; and promoting research relating to spiritual care at national conventions. 118 hospital chaplains also perform and provide a number of other functions and services that cannot be solely characterized by their religious or spiritual nature, including: communicating with caregivers; facilitating staff communi­ cations; resolving conflicts among staff members, patients, and family mem­ bers; referring patients to internal and external resources including other health care providers, patient advocates, and community and social resources; pro­ viding "decedent care"; 119 providing institutional support during organizational 117. professional chaplaincy, supra note 1, at 8-10. 118. !d. 1 i 9. see, e.g., texas health resources, harris methodist southwest hospital: spiritual care, at http://www.texashealth.org/hospitals/default.asp?level=2&id=ab 1 cd4945f6643da 8a99ee4c39970443&enorgid=f9dc671 d200e43c 194f983a4e51 ob2eb (last visited apr. 70 indiana health law review [vol. 2:49 change or crisis; participating in medical rounds and patient care conferences; participating in interdisciplinary education; assisting patients and families in executing or completing advance directives; participating in ethics committees and institutional review boards; clarifying the application of institutional policies and behaviors to patients, community clergy, and religious organiza­ tions; conducting in-service education; interpreting and analyzing cultural traditions that may impact clinical services; representing community issues and concerns to the organization; and acting as "cultural brokers" between insti­ tutions, patients, family members, and staffs.120 in summary, hospital chap­ lains do not limit their services to individuals with needs that are explicitly defined in religious or spiritual terms. 121 e. the role oftoday's hospital chaplain 1. hospital chaplains as members of the health care team because hospital chaplains provide a range of therapeutic, supportive, and administrative services, '<their work often closely resembles, in certain respects, that of psychiatrists, psychologists, psychiatric nurses, social workers, and patient representatives."122 although they do not practice medicine (and are prohibited by state law from doing so without obtaining the appropriate education and licensure}, 123 hospital chaplains believe that religion and spirituality support the fundamental aims of health care and view their ministries as involved in the healing process. "consequently, they view them­ selves as significant members of the healthcare team, and increasingly are being viewed in that way by the medical professions."124 rodney hunter, professor ofpastoral theology at emory university, similarly believes that the identity of hospital chaplains is based not only on religion, but also health and healing generally. 125 additional literature supports the inclusion of the hospital chaplain in the health care team. harold koenig, director of the center for the study of religion/spirituality and health at duke university, recommends that chap­ lains: (1) be fully integrated into the multidisciplinary care team; (2) partici­ pate in morning and afternoon rounds with physicians and nurses; (3) partici24, 2005) {on file with the indiana health law review) {listing services offered by the hospital's pastoral care department). 120. hunter, supra note 33, at 1976. 121. !d. at 1976. 122. !d. 123. see, e.g., tex. occ. code ann. § 155.001 {vernon 2004) {"a person may not practice medicine in this state [of texas] unless the person holds a license issued under the [texas medical practice act]"). 124. hunter, supra note 33, at 1976-77. 125. !d. (citing chaplaincyservicesincontemporaryhealthcare 2 {laurel arthur burton ed., 1992)). 2005] hospital chaplaincy under the hip aa privacy rule 71 pate in discharge planning.126 in situations involving conflicts about treatment decisions due to a patient's or a family's religious beliefs, robert orr, director of clinical ethics at the center for bioethics and human dignity, also recommends that chaplains serve as consultants to the health care team.127 orr emphasizes the ability of chaplains to articulate questioned beliefs in a way that makes both parties to the conflict clearly understand the issues involved. 128 a review of current hospital policies and procedures indicates that many hospitals specifically identify their chaplains as members of the health care team. the pastoral care department of parkland health and hospital system in dallas, texas, explains that, "the chaplain is a part of the healthcare team. patient care situations that involve the spiritual, religious and ethical issues inherent in medicine and healing should involve the chaplain."129 the johns hopkins hospital treats chaplains as members of the multi-disciplinary health care team that reviews cases involving the withdrawal of life support.130 the university of virginia health system ("uv a") explains that, "hospital chap­ lain-counselors, as members of the health care team, endeavor to provide pastoral care and counseling."131 the duties ofuv a's hospital chaplains in­ clude "participat[ing] in staff meetings, family conferences, and discharge planning."132 as members of the health care team, many hospital chaplains "chart," meaning that they document the religious or spiritual care or services provided to patients in their medical records just like physicians, nurses, and other health care professionals document the medical care they provide to patients. a 1996 article reports that the chaplains ofhennepin county medical center, a 400-bed general teaching hospital and level one trauma center located in downtown minneapolis, minnesota (hereinafter, "hennepin"), chart the pastoral care provided to patients by entering a handwritten note in each patient's medical records identifying the chaplain's involvement in the 126. koenig et al., supra note 2, at 451. 127. robert d. orr & leigh b. genesen, requests for 'inappropriate' treatment based on religious beliefs, 23 j. med. ennes 142, 146 (1997). 128. !d. 129. parkland health & hospital system, patients and visitors: pastoral care, at http://www.parklandhospital.com/patients_ visitors/pastcare.html (last visited apr. 21, 2005) (on file with the indiana health law review). 130. procedure for withdrawal oflife support in the micu/mcp § 2.1.1.1, in the johns hopkins hospital medical nursing service standards of care manual (2001) (explaining that before withdrawing life support, there shall be a "family conference with family members, nursing, physicians, and other multi-disciplinary team members as needed, (i.e., chaplain, social work, respiratory therapy).''). 131. university of virginia health system, housestaff policy manual: chaplains, at http:/ /www.healthsystem. virginia.edu/internet lhousestafllpolicy-manuallchaplains.cfin (last modified oct. 17, 2002) (on file with the indiana health law review). 132. !d. 72 indiana health law review [vol. 2:49 patient's care. 133 although the hennepin chaplains reportedly chart almost every patient interaction, many other hospital chaplains chart on a more limited basis. for example, a hospital chaplain may chart patient encounters that result from a specific physician order or nurse referral for spiritual care in order to let the physician or nurse know that the hospital chaplain followed or responded to the physician's order or nurse's referral. however, the same hospital chaplain may not chart other encounters that were not preceded by a physician order or nurse referral. when hospital chaplains chart patient encounters, they will have access to other phi contained in the chart. in fact, it would be almost impossible for a hospital chaplain to write a note in a patient's chart while not seeing the other contents of the chart. 2. hospital chaplains: in-between the worlds of religion and medicine because the identity of many chaplains is based both on health and healing generally, as well as religion, the literature sometimes refers to the hospital chaplain not as a member of the health care team but, instead, as "walk[ing] between the worlds of religion and medicine."134 reverend lawrence holst, former chair of the department of pastoral care at illinois' lutheran general hospital, explains that the hospital chaplain: [i]s both pastor and clinician, theologically educated and clinically trained, endorsed by both church and hospital. a hospital chaplain is of the church but not in the parish. he is nobody's pastor but everybody's pastor. his salary is from the hospital, his mandate from the church. by history and tradition he is closer to his colleagues in the parish ministry, but his daily interactions are with physicians and nurses. in many hospitals the chaplain's garb is a white or blue clinical coat inscribed with a cross-symbols of medicine and religion. often these two worlds are complementary, but sometimes they are contradictory. 135 holst further explains that the hospital chaplain: [w]alks between (1) a faith assumption that the gospel he proclaims has validity and reality despite how, or even whether, it is internally appropriate by the patient and (2) a 133. rob a. ruff, "leaving footprints ": the practice and benefits ofhospital chaplains documenting pastoral care activity in patients' medical records, 50 j. past. care 383, 38391 (1996). 134. holst, supra note 101, at 293. 135. id. 2005] hospital chaplaincy under the hip aa prnacy rule clinical assumption that his faith will have dynamic, func­ tional value for that patient .... 136 73 the characterization of the hospital chaplain not as a member of the health care team but, instead, as "in-between" the worlds of medicine and religion may provide one explanation for hhs' statement that, "clergy or other reli­ gious practitioners that provide solely religious healing services are not health care providers" under the privacy rule. 137 lli. applying the privacy rule to hospital chaplains a. the privacy rule's use and disclosure requirements the privacy rule generally establishes three tiers of patient permission, one of which must be satisfied before a covered entity or one of its workforce members138 can use or disclose phi. first, the privacy rule requires no form of prior patient permission whatsoever before a covered entity, or employee or workforce member thereof, may use or disclose phi to carry out the covered entity's treatment, 139 payment,140 or health care operations activities, 141 136. /d. at 303 (emphasis in original). 137. /d. 138. the privacy rule defines workforce to mean "employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a covered entity, is under the direct control of such entity, whether or not they are paid by the covered entity." 45 c.f .r. § 160.103 (2005). hospital-employed chaplains, chaplains that the hospital contracts with on an independent contractor basis, or otherwise affiliate with, as well as theology students and cpe residents satisfying their clinical pastoral education requirements in the hospital, likely would constitute hospital workforce members. 139. see text accompanying note 149, infra, for the definition of treatment. 140. the privacy rule defines payment to include: (1) the activities undertaken by: ... (ii) a [covered] health care provider or health plan to obtain or provide reimbursement for the provision of health care; and (2) the activities in paragraph (l) of this definition relate to the individual to whom health care is provided and include, but are not limited to: (i) deter­ minations of eligibility or coverage (including coordination of benefits or the determination of cost sharing amounts), and adjudication or subrogation ofhealth benefit claims; (ii) risk adjusting amounts due based on enrollee health status and demographic characteristics; (iii) billing, claims management, collection activities, obtaining payment under a contract for reinsurance (including stop­ loss insurance and excess of loss insurance), and related health care data processing; (iv) review ofhealth care services with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges; (v) utilization review activities, including precertification and preauthorization of services, concurrent and retrospective review of services; and (vi) disclosure to consumer reporting agencies of any of the following protected health infor­ mation relating to collection of premiums or reimbursement .... 45 c.f.r. § 164.501 (2005). 141. see 45 c.f .r. § 164.506( c )(1) (2005) (permitting a covered entity to use and disclose phi "for its own treatment, payment, or health care operations activities" without any form of 74 indiana health law review [vol. 2:49 or one of twelve public policies activities. 142 second, the privacy rule permits covered entities to use and disclose certain limited directory information, 143 to disclose certain relevant information to persons involved in a patient's care in­ cluding family members and friends, and to disclose certain relevant infor­ mation for notification purposes, but only if the covered entity informs the patient in advance of the use or disclosure, the covered entity gives the patient the opportunity to agree to or prohibit or restrict the disclosure, and the patient actually agrees to the disclosure. 144 the patient can provide his or her agreeprior patient pennission); see also 45 c.f.r. § 164.501, which defines health care operations, in relevant part, to mean: [a]ny of the following activities of the covered entity ... : (1) conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generaliz­ able knowledge is not the primary purpose of any studies resulting from such activities; population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination, contacting ofhealth care providers and patients with infonnation about treatment alternatives; and related functions that do not include treatment; (2) reviewing the competence or qualifications of health care professionals, evaluating practi­ tioner and provider perfonnance, health plan perfonnance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities; (3) underwriting, premium rating, and other activities relating to the creation, renewal or replacement of a contract ofhealth insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to claims for health care (including stop-loss insurance and excess of loss insurance), provided that the requirements of §i 64.514(g) are met, if applicable; (4) conducting or arranging for medical review, legal services, and auditing functions, including fraud and abuse detection and compliance programs; (5) business planning and development, such as conducting cost­ management and planning-related analyses related to managing and operating the entity, including fonnulary development and administration, development or improvement of methods of payment or coverage policies; and (6) business management and general administrative activities ofthe entity, including, but not limited to: (i) management activities relating to implementation of and com­ pliance with the requirements ofthis subchapter; (ii) customer service, including the provision of data analyses for policy holders, plan sponsors, or other customers, provided that protected health infonnation is not disclosed to such policy holder, plan sponsor, or customer. (iii) resolution of internal grievances; (iv) ... due diligence ... ; and (v) consistent with the applicable requirements of§ 164.514, creating de-identified health information ... and fundraising for the benefit of the covered entity [for which an individual authorization is not required as described in§ 164.514(e)(2).] 142. these twelve public policy activities are listed at 45 c.f .r. § 164.512( a) to (1)(2005). 143. 45 c.f.r. § 164.510(a)(i)(a)-(d) (2005) (defining directoryinfonnation to include: "(a) the individual's name; (b) the individual's location in the covered health care provider's facility; (c) the individual's condition described in general tenns that does not communicate specific medical infonnation about the individual [i.e., "good," "fair," "poor," "stable"]; and (d) the individual's religious affiliation .... "). 144. id. 2005] hospital chaplaincy under tile hipaa privacy rule 75 ment orally. 145 third, the privacy rule requires the patient's prior written authorization before a covered entity or one of its workforce members may use or disclose phi for any other activity that is not allowed under the first two tiers of patient permission. the authorization form signed by the patient must contain a number of specific elements and statements listed in the privacy rule.146 because most hospitals chaplains would prefer to use phi without having to ensure that the hospital has already obtained a valid, written authori­ zation from the patient, hospital chaplains usually attempt to fit their activities within the first tier of patient permission, which includes those treatment, payment, and health care operations activities that require no form of prior patient permission whatsoever. 147 based on the literature and current hospital practices discussed in part ii of this article characterizing the hospital chaplain as a member of the health care team, one might argue that the hospital chaplain's activities constitute treatment activities. the privacy rule defines treatment as: [t]he provision, coordination, or management of health care and related services by one or more health care providers, including the coordination or management of health care by a health care provider with a third party; consultation between health care providers relating to a patient; or the referral of a patient for health care from one health care provider to another. 148 to constitute treatment, one or more health care providers, or a health care provider with a third party, must be providing, coordinating, or managing health care and related services. the privacy rule defmes health care as: [c]are, services, or supplies related to the health of an indivi­ dual. health care includes, but is not limited to, the follow­ ing: ( 1) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual or that 145. /d. (''the covered entity may orally inform the individual of and obtain the individual's oral agreement or objection to a use or disclosure permitted by this section"). 146. see 45 c.f.r. § 164.508(cx1),(2) (2005). 147. see, e.g., lerrill white & rod pierce, creating h/paa compliant policies and procedures, apc news, july/aug. 2002 (arguing that hospital chaplains are health care professionals involved in treatment of patients), reprinted in ass'n of profl chaplains, professional resources, reading room: hip aa and pastoral care, at http://www.professionalchaplains.orgfprofessional-chaplain-services-resources-reading-room­ hippa-3.htm (last visited apr. 21, 2005) (on file with the indiana health law review). 148. 45 c.f.r § 164.501 (2005). 76 indiana health law review [vol. 2:49 affects the structure or function of the body; and (2) sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription. 149 based on these definitions, one could attempt to argue that hospital chaplains either are health care providers150 or third parties that work with health care providers to provide, coordinate, and manage health care, which is defined to include palliative care, counseling, and assessment services­ services identified in part ii of this article as the responsibility of hospital chaplains. based on this argument, one could tentatively conclude that hospital chaplains engage in treatment activities. however, hhs explains in its preamble: [t]he department [hhs] clarifies that "health care" as de­ fined under the rule does not include methods of healing that are solely spiritual. therefore, clergy or other religious prac­ titioners that provide solely religious healing services are not health care providers within the meaning of this rule .... !sl the import of these two sentences is not clear. for example, does hhs believe that the services that clergy and other religious practitioners provide always constitute "methods of healing that are solely spiritual" or "solely religious services"? or, does hhs believe that clergy and other religious practitioners can provide a range of services, some of which are spiritual or religious in nature and others that constitute "health care"? if the latter is true, would hhs classify the clergy and other religious practitioners who provide a range of services, including counseling and assessment services that fall within the definition of health care, as "health care providers"? 149. 45 c.f.r. § 160.103 (2005). 150. the privacy rule specifically defines a health care provider as one of three types of persons or organizations: "[1] a provider of services (as defined in ... 42 u.s.c. §1395x(u)) [; 2] a provider of medical or health services (as defined in ... 42 u.s.c. § l395x(s)) [;and 3] any other person or organization who furnishes, bills, or is paid for health care in the normal course of business." /d. neither a hospital chaplain, clergyperson, nor any other type of religious practitioner is listed as a provider of services under 42 u.s.c. § 1395x(u) (which lists institutional or organizational health care facilities, including hospitals, nursing facilities, and home health agencies), or a provider of medical or health services under 42 u.s.c. § 1395x(s) (which lists individual health care providers, including physicians, nurses, and social workers). however, one could still argue that a hospital chaplain constitutes a health care provider under the third prong of the definition, which applies to "any other person ... who furnishes ... health care in the normal course of business." 45 c.f.r. §160.103 (emphasis added). however, to fall under the third prong, the person must be furnishing health care and, thus, the analysis would run back into hhs' preamble language which specifically states that health care does not include methods ofhealing that are solely spiritual or religious. see infra note 151 and accompanying text. 151. standards for privacy oflndividually identifiable health information, 65 fed. reg. 82,462, 82,568 (dec. 28, 2000). 2005] hospital chapla1ncy under the hip aa prnacy rule 77 as discussed in more detail in part m.b, several arguments exist that support the conclusion that some services provided by hospital chaplains fall within the definition of"health care." it: however, one interprets the, preamble to conclude that hospital chaplains only provide ''methods of healing that are solely spiritual" or "solely religious services," the technical result is that the hospital must obtain the prior written authorization of the patient if the chap­ lain's activities are not otherwise permitted under the first or second tiers of patient permission. a hospital chaplain's activities generally would not fall within the definitions of payment152 or health care operations153 for purposes of the first tier of patient permission. with a few potential exceptions, a hospital chaplain's activities would not fall within one of the twelve public policy activities also permitted under the first tier of patient permission.154 152. see supra note 140. 153. see supra note 141. at first glance, the term health care operations might appear to include the case management and care coordination activities for which hospital chaplains are responsible as discussed in supra part ii of this article. however, a closer examination of the definition of health .care operations reveals that .these activities must be population-based to qualify as health care operations. 45 c.f.r § 164.501 (2005) (defining health care operations to include "population-based activities relating to ... case management and care coordination"). however, most of the activities in which hospital chaplains engage are patient-specific, not population-based. 154. the twelve public policy exceptions relate to: (1) uses and disclosures required by law; (2) uses and disclosures for certain, specific public health activities; (3) disclosures about victims of abuse, neglect, or domestic violence; (4) uses and disclosures for certain health oversight activities; ( 5) disclosures for judicial and administrative proceedings; ( 6) disclosures for law enforcement purposes; (7) uses and disclosures about decedents; (8) disclosures to organ procurement organizations for cadaveric organ, eye, or tissue donation; (9) uses and disclosures for research activities; (1 0) uses and disclosures to avert a serious threat to health or safety; (11) uses and disclosures for specialized government functions; and (12) disclosures for workers' compensation purposes. 45 c.p.r.§ 164.512(a) to (1) (2005). under the first public policy exception, a covered entity may use or disclose phi without any form of prior patient permission if a federal or state law requires the use or disclosure. /d. § 164.512(a). as discussed in more detail in part id.b.3, below, the joint commission on accreditation of healthcare organizations as well as the regulations implementing the texas hospital licensing law and, perhaps, other state hospital licensing laws, require hospitals to address the spiritual needs of their patients. to the extent that addressing the spiritual needs of patients requires hospital chaplains to access and use phi, the public policy exception set forth at 45 c.p .r § 164.512(a) potentially applies. the strength of this argument is addressed in infra part id.b.3. other public policy exceptions are potentially applicable in certain limited situations. for example, one of the public policy exceptions permits covered entities and their workforce members to disclose phi relating to decedents to coroners, medical examiners, and funeral directors. /d.§ 164.512(g). as discussed in note 119 and the accompanying text in part 11.0, supra, some hospitals require their chaplains to engage in "decedent care." to the extent this care includes communications with funeral directors, coroners, or medical examiners, the public policy exception set forth at 45 c.f.r. § l64.512(g) (addressing uses and disclosures of decedent information) may apply. finally, to the extent a hospital chaplain wishes to use or disclose phi to engage in research about the positive health outcomes associated with religious interventions, for example, the chaplain may attempt to satisfy all of the applicable elements of the research public policy exception set forth 45 c.p.r.§ 164.512(i). 78 indiana health law review [vol. 2:49 under the second tier of patient permission, a hospital chaplain could receive a patient's directory information, defined to include only the patient's name, location in the hospital, general condition described in one word, and religious affiliation (collectively, "directory information") if the patient has agreed to the disclosure of such information. •ss although hospital chaplains who have access only to directory information still could identify and locate patients within the hospital, 156 many of their other roles and job duties, such as participating in ethics committees, hospital rounds, and patient care meet­ ings, would be severely restricted or prohibited. if the hospital chaplain desires access to information beyond directory information, the third tier of patient permission would require the patient to authorize the hospital chaplain's access. the authorization form signed by the patient must contain a laundry list of required elements and statements, including a specific statement identifying the hospital chaplain by title or office as the recipient of the information as well as a statement identifying the specific purposes for which the chaplain would be using the patient's information.157 again, this analysis applies only if one assumes that the services provided by hospital chaplains are limited to "methods of healing that are solely spiritual" or "solely religious services." 155. 45 c.f.r. § 164.510(a)(ii) (permitting disclosures of directory information to members of the clergy). under this regulation, a hospital may disclose to a local catholic priest, for example, the names, locations, and general conditions of those catholic patients who have orally agreed to have their information included in the facility directory. although the office for civil rights has confirmed in an electronically published "frequently-asked question" that hospitals may disclose faith-related directory information to community clergypersons, see u.s. dep't health & human services, questions and answers: privacy of health information/hipaa, answer id 357, at http://answers.hhs.gov/cgi­ binlhhs.cfglphp/enduser/std _adp.pbp?p_sid=xwnbysbh&p_lva=483&p_faqid=357&p_ crea ted= i 040407954&p _sp=cf9zcmnoptemcf9ncmlkc29yddomcf9yb3dfy250ptimcf9zzw fyy2hfdgv4ddljbgvyz3kmcf9jyxrfbhzsmt03jnbfy2fox2x2bdi9finfuex4mcf9wy wdipte*&p_li= (last updated mar 3, 2003) (on file with the indiana health law review), many individuals reportedly believe that the privacy rule interferes with such disclosures. see, e.g., ann rodgers-melnick, privacy rules may limit clergy hospital visits, pfitsburghpost­ gazette, feb. 28, 2003, at e7. 156. the privacy rule only regulates covered entities' uses and disclosures of phi. 45 c.f.r. §§ 164.500, 164.502 (2005). the privacy rule does not prohibit, limit, or otherwise regulate a patient's decision to share. use, or disclose his or her own phi. a hospital chaplain who only has access to directory information could continue to identify and locate patients within the hospital but would have to work harder to obtain (i.e., by asking the patient about) other relevant phi that may assist the chaplain in his or her spiritual assessment and provision of spiritual services to the patient. 157. see 45 c.f.r § 164.508(c)(l)-(2) (2005) (requiring authorization forms to include statements identifying the specific purpose for which the information will be used and the persons, or classes of persons, who will be using the patient's information). 2005] hospital chaplaincy under 1he hip aa prnacy rule b. arguments supporting hospital chaplains' access to phi beyond directory information 79 however, several arguments support hospital chaplains' access to phi beyond directory information without the prior written authorization of the patient who is the subject of the pill. these arguments are based on: (1) hospital chaplains' job duties, which typically extend beyond the provision·of .. solely religious" and .. solely spiritual services"; (2) hhs' failure to distin­ guish hospital-employed, contracted, or affiliated chaplains from community clergypersons; (3) state laws and joint commission on accreditation of healthcare organizations standards requiring hospitals to address patients' spiritual needs; (4) numerous studies that characterize religion as an epide­ miologically protective factor; (5) statements by the medicare program acknowledging that pastoral care has a beneficial and therapeutic effect on patients' medical conditions; and (6) the lack of any reported cases involving hospital chaplains' inappropriate use or disclosure of pill. each of these argu­ ments is discussed in more detail below. i. hospital chaplains provide services other than "solely religious" or "solely spiritual, services the preamble states that health care does not include methods ofhealing that are .. solely spiritual," and that clergy or other religious practitioners that provide "solely religious" healing services are not health care providers. 158 however, all of the services provided by hospital chaplains cannot be char­ acterized as solely spiritual or religious. as discussed in more detail in part ll.d, hospital chaplains provide many non-religious services including, but certainly not limited to, coordinating referrals to other support services includ­ ing patient advocates, financial services, social workers, and psychologists; communication with caregivers; facilitation of hospital staff communication; conflict resolution among staff members, patients, and family members; paperwork relating to death and coordination of transfers of decedents to the morgue; and participation in institutional ethics committees and institutional review boards. because hospital chaplains provide palliative, counseling, and other services that are not solely religious or spiritual in nature and that could constitute the coordination or management of health care, an argument exists that hospital chaplains are health care providers under the privacy rule. 159 158. standards for privacy of individually identifiable health information, 65 fed. reg. 82,462, 82,568 (dec. 28, 2000). 159. see supra note 150 (defining health careprovider);seea/so josephj. driscoll,hipaa calling the question: is the chaplain a health care professional? vision, may 2003, at 4, available at http://www.nacc.org/docs/resources/hip aa _calling_ the_ question. pdf (arguing that the hospital chaplain is a health care professional); id. at 5 (arguing that "in principle, the chaplain as a health care professional has full access just as any other member of the team"); 80 indiana heal til law review [vol. 2:49 2. hhs fails to distinguish between hospital chaplains and community clergypersons neither the privacy rule nor its voluminous preamble recognizes the hospital chaplain as distinct from the community clergyperson; the only specific religious practitioners hhs identifies or discusses are "members of the clergy,"160 and such discussion usually occurs in the context of allowing clergy access to directory information. accordingly, one may argue: that hhs does not understand the distinction between community clergy and hospital chaplains161 and that hhs should: (1) distinguish between clergy and chap­ lains; and (2) clarify that clergy only have access to directory information and that chaplains have access to the phi necessary to address the spiritual needs of their patients. the term clergy generally refers to the duly authorized community repre­ sentatives of the various faith groups. for example, the texas rules of evidence, which establishes a confidential privilege relating to communica­ tions to members of the clergy, defines the term clergy to mean "a minister, priest, rabbi, accredited christian science practitioner, or other similar func­ tionary of a religious organization or an individual reasonably believed so to be by the person consulting with such individual."162 on the other hand, the michele ledoux sakurai, hip aa & privacy: regulations impacting spiritual care in health care, vision, oct. 2()()1, at 4 (''chaplains may find themselves advocating for their position as members of the interdisciplinary team . • • "), available at http:llwww.nacc.org/visionl highlights/2001/oct2001-hipaa.htm;lerrillwhite,pastoralcareprovidersaremembersofthe healthcare team in accordance with the regulations of the department of health & human services, apc news, jan./feb.2003, (revised jan. 2005) (arguing that pastoral care providers are health care providers for purposes of the privacy rule), reprinted in ass'n of prof'l chaplains, professional resources, reading room: hip aa and pastoral care, at http:/lwww.professionalchaplains.orglprofessional-chaplain-services-resources-reading-room.­ hippa-5.htm (last visited apr. 21, 2005) (on file with the indiana health law review). 160. see, e.g., 45 c.f.r. 164.510(axiixa) (2005) (explaining that covered health care providers may disclose to members of the clergy: (a) the individual's name; (b) the individ­ ual's location in the covered health care provider's facility; (c) the individual's condition described in general terms that does not communicate specific medical information about the individual; and (d) the individual's religious affiliation ... " (emphasis mine); see also standards for privacy of individually identifiable health information, 65 fed. reg. at 82,568 (stating that, '"health care' ... does not include methods of healing that are solely spiritual. therefore, clergy or other religious practitioners that provide solely religious healing services are not health care providers within the meaning of this rule .... ") (emphasis added). 161. see, e.g., lerrill white & rod pierce, hip aa regulations' impact on visitation by clergy, lay ministers and faith group representatives, apc news, may/june 2002 ( distin­ guishing hospital chaplains nom community clergy and faith group representatives) reprinted in ass'n ofprofl chaplains, professional resources, reading room: hipaa and pastoral care,athttp:llwww.professionalchaplains.orglprofessional-chaplain-services-resources-reading­ . room-hippa-2.htm (last visited apr. 21, 2005) (on tile with the indiana health law review); letter from the national associations of catholic chaplains, to colleagues (mar. 3, 2003) (on tile with author) ("the wording ofthe rule. does not offer a clear distinction between "area clergy" and "professional chaplain"). 162. tex. r. evm. 505(ax1). 2005] hospital chaplaincy under the hip aa privacy rule 81 term chaplain specifically refers to those individuals who are associated with a particular organization and who are charged with providing emotional, pastoral, or spiritual care to members of the organization. for example, the american heritage dictionary defmes a chaplain as, "[a] member of the clergy who conducts religious services for an institution, such as a prison or hospital.''163 these definitions recognize an important distinction between clergy and chaplains: clergy are individuals authorized to represent their parti­ cular faith groups in the community, while chaplains are individuals employed by, or otherwise associated with, institutions and whose roles include provid­ ing spiritual and other services to members of the institution. it follows that the phrase hospital chaplain would refer to an individual employed by a hospital who is specially trained to provide pastoral care and other services to patients, family members, and other individuals associated with the hospital. thus, one could argue that hhs' use of the term clergy in connection with accessing directory information, 164 and its failure to distinguish community clergy from hospital chaplains is evidence that hhs is unaware of the unique role of the hospital chaplain.165 although the deadline for submitting comments. relating to the privacy rule has long since passed, 166 one suggestion is for the acpe and other pro­ fessional chaplain associations to continue submitting questions to the office for civil rights ("ocr"), the office within hhs responsible for enforcing the privacy rule. 167 although the ocr will not provide individual responses, the ocr may, after receiving a sufficient number of questions relating to the same issue, respond by publishing a new "frequently-asked question" or guidance document distinguishing between clergy and chaplains and addressing whether hospital chaplains may access pin beyond directory information.168 163. the american heritage dictionary of the engijsh language (4th ed. 2000). 164. see, e.g.,45 c.p.r.§ 164.510(axii)(a)(explainingthatcoveredhealthcareproviders may disclose directory infonnation to "members of the clergy) (emphasis added). 165. see, e.g., harold y. vanderpool, is religion therapeutically significant?, 16 j. reugious health 255 (1977) ("our most common visual image of this relationship is probably that of a chaplain visiting a large hospital.''). 166. hhs issued its last set of proposed modifications relating to the privacy rule on march 27, 2002. see standards for privacy of individually identifiable health infonnation, 67 fed. reg. 14,776 (proposed mar. 27, 2002). the time period for submitting comments relating to this proposed rule ended on april26, 2002. see id. 167. ocr accepts comments relating to the privacy rule by electronic mail at ocrprivacy@hhs.gov. see u.s. dep't ofhealth & hunian servs., office of civil rights­ hippa: how to contact the office for civil rights (ocr), at http://www.hhs.gov/ocr/ contact.html (last revised july 14, 2003) (on file with the indiana health law review) (explaining that the ocr will not provide individual responses to electronic mail but will respond to concerns of general interest through development of new "frequently-asked questions" and published guidance documents}. 168. id. although several health care attorneys, including myself: have submitted comments to the ocr relating to the use of phi by hospital chaplains, the ocr has not yet issued a "frequently-asked question" or guidance document addressing whether hospital chaplains may access the phi of inpatients. however, the ocr has confirmed that community clergypersons can access directory information relating to patients of their own faith tradition. 82 indiana health law review [vol. 2:49 3. jcaho standards and state laws require hospitals to address patients' spiritual needs the joint commission on accreditation of healthcare organizations ("jcaho") is an independent, not-for-profit organization that evaluates and accredits more than 16,000 health care organizations and programs in the united states, including hospitals. hospitals and other health care organiza­ tions that are eligible for certification as a provider under the federal medicare program can choose to be surveyed by jcaho. it: following the survey, jcaho determines that the hospital is in substantial compliance with the relevant jcaho standards,169 the hospital will earn jcaho accreditation and also will be "deemed" to comply with the federal centers for medicare and medicaid services' ("cms"') requirements for hospitals, known as the "conditions of participation for hospitals.'mo one of jcaho's hospital accreditation standards explains that, "[e]ach patient has a right to have his or her cultural, psychosocial, spiritual, and per­ sonal values, beliefs, and preferences respected."171 the same standard also explains that, "[t]he hospital [must] accommodated the right to pastoral and other spiritual services for patients. "172 with respect to end-of-life care, jcaho's standards further explain that, "[t]he hospital [must] provide[] care that ... addresses the patient's and his or her family's psychosocial and spiritual needs."173 u.s. dep't ofhealth & human servs., questions and answers: privacy ofhealth information/ hip aa, answer id483, at http://answers.hhs.gov/cgi-binlbhs.cfglphplenduser/ std_adp.php?p _ sid=vnm3xudh&p_lva=&pjaqid=483&p_created=1067889406&p_sp=cf9zcmnoptemc f9ncmlkc29yddomcf9yb3dfy250ptimcf9zzwfyy2hfdgv4ddljbgvyz3kmcf9jyxrfb hzsmt03jnbfy2fox2x2bdi9finfuex4mcf9wywdi.pte•&p_li=(lastupdatednov. 4, 2003) (on file with the indiana health law review). 169. jcaho has developed different standards for each type of health care organization it accredits including ambulatory care providers, assisted living providers, behavioral health care providers, critical access hospitals, health care networks, home care providers, hospitals, laboratory service providers, long-term care providers, and office-based surgery practices. for more information regarding the organizations jcaho accredits and jcaho's accreditation standards, see joint comm. on accreditation ofhealthcare orgs., for accredited organizations, at http://www jcaho.orglaccredited+organizations/index.htm (last visited apr. 21, 2005) (on file with the indiana health law review). 170. cms has codified its conditions ofparticipation for hospitals at 42 c.f .r. part 482. 171. joint commission on accreditationofiiealthcare0rganizations, hospital accreditation standards rl.2.10(2) (2004) [hereinafter jcaho standards}. 172. id. atri.2.10(4). 173. !d. at rationale for pc.8. 70. jcaho specifically identifies those elements that must be addressed in a hospital's spiritual assessment: spiritual assessment should, at a minimum, determine the patient's denomina­ tion, beliefs, and what spiritual practices are important to the patient. this information would assist in determining the impact of spirituality, if any, on the care/services being provided and will identity if any further assessment is needed. the standards require organizations to define the content and scope of spiritual and other assessments and the qualifications of the individual(s) performing the assessment. 2005] hospital chaplaincy under the hip aa prnacy rule 83 many state laws also require hospitals to respect patients • spiritual values. for example, the regulations implementing the texas hospital licens­ ing law require texas hospitals to "acknowledg[e] the psychosocial and spiritual concerns of the patient and the family regarding dying and the expres­ sion of grief by the patient and family."174 the same regulations explain that, "the care of the patient includes consideration of the psychosocial, spiritual, 175 and cultural variables that influence the perceptions of illness."176 if a state or federal law requires a covered entity, or a workforce member thereof, to use or disclose pill, the privacy rule also permits the use or disclo­ sure. 177 one could argue that because accreditation standards and state regula­ tions require hospital chaplains to address the spiritual needs of their patients, examples of elements that could be but are not required in a spiritual assessment include the following questions directed to the patient or his/her family: who or what provides the patient with strength and hope? does the patient use prayer in their life? how does the patient express their spirituality? how would the patient describe their philosophy oflife? what type of spiritual/religious support does the patient desire? what is the name of the patient's clergy, ministers, chaplains, pastor, rabbi? what does suffering mean to the patient? what does dying mean to the patient? what are the patient's spiritual goals? is there a role of church/synagogue in the patient's life? how does your faith help the patient cope with illness? how does the patient keep going day after day? what helps the patient get through this health care experience? how has illness affected the patient and his/her family? joint commission on accreditation of health care organizations, long term care: spiritual assessment, at http://www.jcaho.orglaccredited+organizationsllong+term+carel standards/faqs/provision+of+carelassessment/spiritual+assessmenthtm. (last revised jan. 1, 2004) (on file with the indiana health law review). 174. 25 tex. admin. code§ 133.42(a)(i)(b)(ii)(iii) (west 2005). 175. both the jcaho standards as well as the regulations implementing the texas hospital licensing law use the term spiritual, but neither jcaho nor the texas department of state health services define the term. however, a 2001 white paper adopted by the association for clinical pastoral education, the association of professional chaplains, the national association of catholic chaplains, and the national association of jewish chaplains, explain that the word spirituality "describes an awareness of relationships with all creation, an appreciation of presence and purpose that includes a sense of meaning." professional chaplaincy, supra note 1, at 2. the white paper further explains that the term spirituality is broader than the term religion and that spirituality includes religion and that spiritual care includes pastoral care. ld.; see also koenig et al., supra note 2, at 17-23 (discussing the definitions of spirituality and religion); paul s. mueller et al., religious involvement, spirituality, and medicine: implications for clinical practice, 16 mayo cunic proc. 1225 (2001) (explaining that religion refers to participation in o~ganizedreligion whereas spirituality refers to participation in personal processes, such as an individuat•squest for meaning, purpose, or transcendence); burton & bosek, supra note 1, at 98 (discussing the difference between religion and spirituality). 176. 25 tex. admin. code§ 133.42(a)(l)(b)(i). 177. 45 c.f.r § 164.512{a){l)(2005) ("a coveredentitymayuse or disclose protected health information to the extent that such use or disclosure is required by law and the use or disclosure complies with and is limited to the relevant requirements of such law''). 84 indiana health law review [vol. 2:49 and because hospital chaplains need access to phi to address these needs, 178 then the privacy rule would permit such access.179 4. religion is an epidemiologically protective factor numerous published studies, meta-analyses, systematic reviews, and subject reviews examining the association between religion or spirituality and health outcomes find that religious involvement and spirituality are associated with better health outcomes, including greater longevity, coping skills, and health-related quality of life, as well as less anxiety, depression, and suicide. 180 a discussion of all of the literature and studies linking religion and spirituality to better health outcomes181 is beyond the scope of this article. however, one 178. as discussed in the text accompanying note 156, supra, hospital chaplains who have access only to directory information still can identify and locate patients within the hospital. however, many of the chaplains' other job duties, such as participating in ethics committees, hospital rounds, and patient care meetings, would be severely restricted or prohibited. 179. 45 c.f.r. § 164.512(ax1). 180. see levin et al., supra note 2; mueller et al., supra note 175, at 1225. the fourth edition of the diagnostic and statistical manual of mental disorders also recognizes religion and spirituality as relevant sources of emotional support (and distress). american psychiatric association, diagnostic and statistical manual of mental disorders 685 (4th ed., 1994). 181. see, e.g., mueller et al., supra note 175, at 1226 (noting that "a majority of the nearly 350 studies of physical health and 850 studies of mental health that have used religious and spiritual values have found that religious involvement and spirituality are associated with better health outcomes."); sloan et al., supra note 2, at 664-67 (discussing the empirical evidence relating religion and health outcomes); paul alexander clark et al., supra note 2, at 659 (stating that "the joint commission on accreditation of healthcare organizations (jcaho) has acknowledged that patients' 'psychosocial, spiritual, and cultural values affect how they respond to their care' .... "and that "data analysis revealed a strong relationship between the 'degree to which staff addressed emotional/spiritual needs' and overall patient satisfaction."). for discussions of the relationship between religion or spirituality and health, see generally larry dossey, healing words: the power of prayer and the practice of medicine 161-230 (1993); koeniget al.,supra note 2, at 53-381 and 513-589; pastor and patient: a handbook for clergy who visit the sick (richard dayringer ed., 1982); the spiritual challenge of health care (mark cobb & vanessa robshaw eds., 1998); a. gray, the spiritual component of palliative care, 8 paluative med. 215 (1994); martha ellen f. highfield, providing spiritual care to patients with cancer, 4 clinical j. oncology nursing 115 (2000); jeffreys. levin & linda m. chatters, research on religion and mental health: an overview of empirical findings, in handbookofreilgion and mental health 33, 33-50 (harold g. koenig ed., 1998); jacqueline r. mickley et al., spiritual well-being, religiousness and hope among women with breast cancer, 24 image j. nursing scholarship. 267 (1992); william r. miller & carl e. thoresen, spirituality, religion, and health: an emerging research field, 58 am. psychologist 24 (2003); william r. miller & carl e. thoreson, spirituality and health, in integrating spirituality into treatment 3-18 (william r. miller ed., 1999); mueller et al., supra note 175, at 1225; johanna j. mytko & sara j. knight, body, mind and spirit: towards the integration of religiosity and spirituality in cancer quality of life research, 8 psycjiq-oncology 439 (1999); t.a. peri, promoting spirituality in persons with acquired immunodeficiency syndrome: a nursing intervention, 10 hoilstic nursing prac. 68 (1995); c.m. puchalski & d.b. larson, developing cu"icu/a in spirituality and medicine, 73 academic med. 970 (1998); l. ross, the spiritual dimension: 2005] hospital chaplaincy under the hipaa privacy rule 85 could rely on these studies to argue that: (1) religion and spirituality are epide­ miologically protective factors; and, therefore (2) the provision of religious and spiritual services by hospital chaplains constitutes health care under the privacy rule. 5; . the medicare program recognizes that pastoral care has a ··"beneficial and therapeutic effect" on patients' medical conditions ·although the medicare program does not directly pay hospitals for the costs of the pastoral care and other services provided to hospital patients by hospital chaplains, hospitals historically have been permitted to include such costs in their administrative and general ("a&g") cost centers.182 effective march 13, 2001, the federal centers for medicare and medicaid services ("cms") adopted a regulation specifically permitting hospitals to claim the reasonable costs associated with the provision of clinical pastoral education, which include the costs associated with providing a minimum of one year (or 1200 hours) of supervised clinical experience required for chaplain who wishes to become board certified.183 in a regulatory provision establishing the methodology for paying for the costs of "approved nursing and allied health education activities," cms explained that activities accredited by the associa­ tion for clinical pastoral education ("acpe") would constitute an approved program: approved nursing and allied health education programs. cms will consider an activity an approved nursing and allied health education program if the program is a planned program of study that is licensed by state law, or if licensing is not required, is accredited by the recognized national professional organization for the particular activity. such national accrediting bodies include, but are not limited to, the com­ mission on accreditation of allied health education pro­ grams, the national league of nursing accrediting com­ mission, the association for clinical pastoral education inc., and the american dietetic association. 184 interestingly, a member of the public voiced his disagreement with the inclu­ sion of clinical education as an approved program for medicare payment, its importance to patients' health, well-being and quality of life and its implications for nursing practice, 32int. j. nursing stud. 457 (1995); j. walton, spiritual relationships: a concept analysis, 14 j. holistic nursing 237 (1996). 182. medicare program; payment for nursing and allied health education, 66 fed. reg. 3358, 3366 (jan. 12, 2001). 183. see id at 3358 {noting an effe<:tive date ofmarch 13, 2001). 184. 42 c.f.r. § 413.85(e) {2005) (emphasis added). 86 indiana health law review [vol. 2:49 arguing that: (1) such a policy would violate the requirement for separation of church and state; and (2) pastoral counseling does not qualify as direct patient care because medicare does not pay directly for the care provided by pastoral counselors. 185 however, cms responded to the comment on january 12, 2001, by explaining that, "[a ]s early as the mid-1970s, medicare recognized pastoral care as having a beneficial and therapeutic effect on the medical condition of a patient, and, therefore, the costs a provider incurs to furnish such care to its patients are considered patient care related costs."186 in addition, cms published its final changes to the hospital inpatient prospective payment systems and fiscal year 2004 rates on august 1, 2003.187 in that publication, cms concluded that hospitals are not eligible to receive reimbursement for the reasonable costs of: (1) cpe internships (or any other cpe training that is a requirement for a degree, whether undergraduate, graduate, or doctoral); (2) second year cpe residencies, or any cpe beyond 1600 hours; and (3) supervisory cpe. however, cms also concluded that hospitals are eligible to receive reimbursement for the reasonable costs of operating the first year of cpe residencies that consist of 1600 hours of training and that lead to board certification in chaplaincy. 188 in summary, the medicare program continues to view pastoral care as having a beneficial and therapeutic effect on patients' medical conditions and continues to allow hospitals to include costs relating to most first year cpe residencies in their a&g cost centers. accordingly, an argument exists that hospital chaplains who have completed a one-year cpe residency for board certification are like other allied health professionals whose services are viewed as health care under the privacy rule. 6. hospital chaplains do not inappropriately use or disclose phi a final argument requires a return to the reason hhs adopted the privacy rule in the first place. privacy breaches that caught hhs' attention included cases in which: (1) a michigan-based health system accidentally posted the medical records of thousands of patients on the internet; (2) a utah­ based pharmaceutical benefits management firm used patient data to solicit business for its owner, a drug store; (3) an employee of the tampa, florida, health department took a computer disk containing the names of 4000 people who had tested positive for hiv; (4) the health insurance claims forms of thousands of patients blew out of a truck on its way to a recycling center in east hartford, connecticut; (5) a patient in a boston-area hospital discovered that her medical record had been read by more than 200 of the hospital's 185. medicare program; payment for nursing and allied health education, 66 fed. reg. at3366. 186. id. 187. medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2004 rates, 68 fed. reg. 45,346, 45,668 (aug. 1, 2003). 188. ld. at45,426-27. 2005] hospital chaplaincy under the hipaaprlvacy rule 87 employees; ( 6) a nevada woman who purchased a used computer discovered that the computer still contained the prescription records of the customers.of the pharmacy that had previously owned the computer (the pharmacy data base included names, addresses, social security numbers, and a list of all the medicines the customers had purchased); (7) a speculator bid $4000 for the patient records of a family practice in south carolina and attempted to sell the purchased records back to the former patients; (8) johnson and johnson reportedly marketed a list of five million names and addresses of elderly incontinent women without their permission; and (9) a few weeks after an orlando woman had her doctor perform some routine tests, she received a letter from a drug company promoting a treatment for her high cholesterol.189 neither the preamble to the privacy rule nor case law research identified one reported case in which a hospital chaplain was alleged to have inappropriately used or disclosed a patient's phi.190 thus, one could argue that the privacy breaches that prompted hhs to adopt the privacy rule did not occur in the context of hospital chaplaincy and that limiting chaplains' access to phi will not reduce an already low risk of inappropriate health information management. iv. conclusion the preamble to the federal department ofhealth and human services' privacy rule is, perhaps, the latest chapter in the history of the continually evolving relationship between american medicine and religion. over the last four centuries, the medical and religious establishments in the united states have engaged in action and reaction, participation and withdrawal, and com­ petition and cooperation with respect to their professional domains. depend­ ing on when asked, one might have described american medicine and religion as incompatible, complimentary, or even augmentative, or as enemies or allies. by outlining an almost exclusive role for medicine in the provision of health care and related social and support services and attempting to limit religious 189. standards for privacy oflndividually identifiable health information, 65 fed. reg. 82,462, 82,467 (dec. 28, 2000). 190. chaplains may have a heightened understanding of the necessity of maintaining the confidentiality of information revealed to them in light of state statutory provisions that typically establish privileges for persons who communicate with members of the clergy and that permit such persons to prevent clergy from disclosing confidential communications. for example, the texas rules of evidence states that, "[a] person has a privilege to refuse to disclose and to prevent another from disclosing a confidential communication by the person to a member of the clergy in the member's professional character as spiritual adviser." tex. r. evid. 505(b ). see generally james j. gill & dana l. farnsworth, confidentiality, in psychiatry, the clergy andpastoralcounseuno: the st. john's story 313,313-22 (dana l. farnsworth & francis j. braceland eds., 1969) (discussing the need for confidentiality in the context of pastoral counseling). 88 indiana health law review [vol. 2:49 practitioners to the role of just visiting the sick, 191 religion is not currently viewed, at least byhhs in its privacy rule, as complimentary or augmentative of medicine. regardless of their legislatively or regulatively prescribed domains,192 religion and medicine share many common purposes, functions, and actions.193 many scholars of religion and medicine have concluded that religion cannot possibly be divorced from medicine. 194 thus, one might ask why hhs felt the need to exclude "methods of healing that are solely spiritual" and "solely religious healing" from the definition of health care. perhaps one explanation lies in the changing health care environment. in an era of managed care, where every cost is scrutinized and every benefit carefully assessed, chaplains must justify their presence in modem hospitals. 195 many hospital chaplains are expected to demonstrate .a measurable impact of their services in terms of speed· recovery, improved outcomes, and increased patient satisfaction, and to show that their services either will save money or increase hospital revenue.196 unfortunately, many clinically-oriented hospital chaplain programs have neither the time nor the resources to: (1) document existing relationships between religious involvement and health outcomes relating to depression, prevention, and speed of recovery, among other outcomes; or (2) conduct additional research showing a positive. relationship between pastoral care and better health outcomes. managed care organizations thus place hospital chaplains in a tricky position by asking them to justify their existence.197 chaplains that fail to demonstrate and document a positive effect of their services on patient outcomes may be released or replaced by contract or part­ time chaplains. for example, on october 31, 1991, the georgia legislature decided to make up a $415 million budget deficit by eliminating all of the full­ time clinical chaplain positions in its state-operated facilities. 198 the changing health care environment may not be the only reason why hhs excluded "methods of healing that are solely spiritual" and "solely religious healing" from the definition of health care. perhaps the physicians and other members of the medical establishment who submitted comments to 191. see, e.g., pastor and patient: a handbook for clergy who visit tim sick (richard dayringer ed., 1982) (the title speaks for itself); vanderpool, supra note 165, at 255 ("a very common, although not necessary accurate, image of the relationship between religion and medicine is the image of a chaplain visiting a large hospital."). 192. harold y. vanderpool & jeffreys. levin, religion and medicine: how are they related?, 29 j. reugion & health 9, 14 (1990) (''over time, hwrians have, of course, defined distinctive· roles for the domains of religion and medicine; yet much sharing and competing remains."); 193. !d. at 9 (discussing the shared purposes, functions, and actions of religion and medicine). 194. foster, supra note 36, at 249. 195. koenig et al., supra note 2, at 450. 196. !d. 197. id. at 450-51. 198. id 2005] hospital chaplaincy under thbhipaa privacy rule 89 hhs regarding the 1999 proposed privacy rule and the 2002 proposed modifications were concerned about hospital chaplains and other religious practitioners encroaching on their professional domains. on the other hand, perhaps hhs simply was unaware of the special training, the unique role, and the diverse job functions of today' s hospital chaplain. regardless of the reason for its preamble, hhs needs to clarify whether hospital chaplains have access to phi beyond directory information. ·three potential approaches for hhs to consider include an opt-out approach, an opt­ in approach, or a do-nothing approach. a. an opt-out approach one approach is for hhs to amend the privacy rule to align religious and spiritual services with treatment, payment, and health care operations activities. currently, 45 c.f.r. § 164.506 allows covered entities to use and disclose phi for treatment, payment, and health care operations activities without the prior written authorization of the individual who is the subject of the information.199 hhs could consider adding a new paragraph (d) to 45 c.f .r. § 164.506 to give hospital chaplains access to phi as necessary to carry out their duties and to address patients' spiritual needs in accordance with jcaho standards and state law, as appropriate. although hospital chaplains and professional chaplain associations are in the best position to propose language that would accomplish this goal, one formulation is: (d) implementation specifications: religious and spiritual activities,· other support services. hospital chaplains may use or disclose protected health information to provide religious, spiritual, and related support services as required to address the spiritual needs of patients in accordance with the applic­ able standards of the joint commission on accreditation of healthcare organizations and the requirements of applicable state law. hhs, hospital chaplains, and professional chaplain associations could work together to define those activities that constitute religious and spiritual activities for purposes of the amendment. currently, the privacy rule allows individuals to request covered entities for greater privacy protections under 45 c.f.r. § 164.522. for example, if a patient does not want his or her phi used for treatment, payment, or health care operations activities, the patient is permitted to request the covered entity to restrict uses and disclosures for such activities20cl although the covered entity 199. 45 c.f.r. § 164.506(cx1)(2005). 200. id. § 164.522(ax1xixa). 90 indiana heal til law review [vol. 2:49 is not required to agree to the request. 201 to accommodate patients who do not want hospital chaplains to use their phi, hhs could further amend 45 c.f .r. § 164.522 to add a new paragraph (a)(l)(i)(c), which would permit patients to request restrictions relating to: (c) uses or disclosures of protected health information. permitted under§ 164.506(d). finally, hhs could amend 45 c.f.r. § 164.522(a)(l)(ii) to provide that: (ii) a covered entity is not required to agree to a restriction under paragraphs (a)(l)(i)(a) and (b) of this section. a covered entity is required to agree to a restriction under paragraph (a)(l)(i)(c) of this section. these amendments offer one attempt to balance the religious and spiritual needs of some patients and the requirements for hospitals to address patients' spiritual care with the rights of patients not to receive religious and spiritual care. one possible critique is that this approach implicates the establishment clause of the first amendment, which prohibits laws ''respecting an establish­ ment of religion. "202 this critique might stem from the incorrect belief that hospital chaplains are allowed to proselytize with respect to a particular faith tradition. 203 in determining whether the amendments would violate the esta­ blishment clause, a court would analyze whether the amendments have a bona fide secular purpose and whether their primary effect is to advance or inhibit religion. 204 after speculating whether the provision in the privacy rule allowing covered entities to disclose directory information to community clergypersons205 violated the establishment clause, hhs concluded that that the provision exists "as an accommodation to patients who seek to engage in religious conduct" and that it "avoids a government-imposed restriction on the disclosure of information that could disproportionately affect the practice of religion. "206 a similar argument could be made that the regulatory proposals described in this part iv.a only seek to accommodate patients who want religious or spiritual care and that the proposal requiring covered entities to 201. id. § 164.522(a)(l)(ii). 202. u.s. const. amend. i. 203. professional chaplaincy, supra note 1, at 8 ("professional chaplains reach across faith group boundaries and do not proselytize."). 204. lemon v. kurtzman, 403 u.s. 602, 612-13 (1971); see agostini v. felton, 521 u.s. 203 (1997); county of alleghenyv. aclu, 492 u.s. 573 (1989). 205. 45 c.f.r. § 164.510(a)(l)(ii)(a) (2005). 206. standards for privacy of individually identifiable health information, 65 fed. reg. 82,462, 82,522 (dec. 28, 2000) (''the privacy regulation passes this test because its purpose is to protect the privacy of individuals-regardless of their religious affiliation-and it does not cause excessive government entanglement."). 2005] hospital chaplaincy under the hip aa privacy rule 91 adhere to patient requests to opt out of receiving religious and spiritual care will ensure that no religion is advanced. b. an opt-in approach a second approach is to amend the privacy rule to allow hospital chap­ lains to access phi only if a patient "opts in" to religious or spiritual care, assessment, or counseling through an in-person interview or a written docu­ ment provided to the patient at the time of registration or admission. under this approach, the chaplain would be limited to using directory information about the patient if the patient did not opt in. to formulate this approach, hhs could consider adding a new paragraph (c) to 45 c.f .r. § 164.510, as follows: (c) standard: uses for religious and spiritual activities and related support services. a hospital chaplain may use a patient's protected health infonnation to provide religious and spiritual activities and related support services if the patient agrees orally or in writing to such use. the covered entity shall document the patient's agreement in the medical record. as with the opt-out approach, hhs, hospital chaplains, and professional chaplain associations could work together to define those activities that constitute religious and spiritual activities and related support services. in attempting to balance the religious and spiritual needs of some patients with the rights of other patients not to receive religious or spiritual care, this approach gives greater weight to the rights of patients not to receive religious or spiritual care. this approach has the benefit of not raising any issues under the establishment clause because the hospital chaplain would only be providing religious or spiritual services to a patient if the patient specifically requested or agreed to the use of his or her information for such services. however, this approach potentially runs afoul of state laws and jcaho standards that require hospitals to address the religious and spiritual needs of patients. this approach also would interfere with or completely eliminate the ability of chaplains to perform many of the other job functions described in part ii.d of this article. moreover, this approach places the burden on patients who did not opt in to religious and spiritual care but who later change their minds to specifically request such services. finally, this approach would require significant changes to the policies and practices of many hospitals that currently allow chaplains full access to the phi of inpatients. c. the do-nothing approach a third approach is for hhs to leave the privacy rule as is. hhs would benefit from the do-nothing approach because it would avoid the lengthy 92 indiana heal1h law review [vol. 2:49 notice and comment rulemaking process required to amend the privacy rule. 207 however, health care attorneys and hospital chaplains would continue to debate the intetpretation of the preamble language excluding "methods of healing that are solely spiritual" and "solely religious services" from the definition ofhealth care.208 regardless of whether hhs adopts an opt-out approach, an opt-in approach, or a do-nothing approach, its action (or omission) will add a new chapter to the history of religion and medicine. 207. hhs still could adopt an official position and avoid the notice and comment rulemaking process by issuing a new "guidance" document or publishing a new response to a frequently-asked-question. see supra notes 167 and 168. 208. see supra text accompanying notes 4, s, 6, and 7. microsoft word 1-masthead vol. viii.doc focusing on fraud: the federal government expands its use of the false claims act to police off-label pharmaceutical promotion kristin mccreary eichel∗ in addition to ensuring that those who defraud the government will pay, cases like pfizer send a strong message that if companies violate the law, if companies put profits ahead of patient health, we will hold them accountable.1 i. introduction ............................................................................... 400 a. the issue .................................................................................. 402 b. roadmap .................................................................................. 403 ii. background: a look into the history surrounding regulation of off-label promotion ..................................... 403 a. regulating off-label promotion under the fdca ................. 403 1. the fda’s new drug approval process .......................... 404 2. what is an off-label use? ................................................ 405 3. violating the fdca through off-label promotion.......... 406 4. is off-label marketing problematic? ............................... 407 a. benefits of off-label use and marketing ...................... 407 b. risks associated with off-label use and marketing ..... 409 c. defining acceptable promotion practices ................... 410 b. regulating fraud and off-label promotion through the false claims act ..................................................................... 412 1. noteworthy provisions of the fca .................................... 412 a. qui tam provision ....................................................... 412 b. possibility of government intervention ....................... 413 c. threat of treble damages. ........................................... 414 2. applying the fca to off-label promotion ....................... 414 iii. analysis: taking a look at the pharmaceutical industry’s liability for off-label marketing as ∗ j.d. candidate, 2011, indiana university school of law—indianapolis; b.a., 2006, indiana university. 1. tony west, assistant att’y gen., u.s. dep’t. of justice, remarks at the national association of medicaid fraud control units 2009 annual training program (sept. 14, 2009). 400 indiana health law review [vol. 8:2 the scope of federal enforcement continues to expand through the false claims act ................................. 416 a. the expansion of the false claims act ................................... 416 1. executive expansion of the fca ....................................... 417 a. the doj has the ability to bypass fda’s regulatory authority to enforce federal law .................................. 417 b. steady increase in amount and magnitude of settlements ................................................................... 419 c. doj’s focus on fraud .................................................. 421 2. judicial interpretation of the fca .................................... 422 a. franklin v. parke-davis ............................................. 423 b. an attempt to limit fca expansion ............................. 424 3. legislative expansion of the fca ..................................... 427 a. fraud enforcement and recovery act amends the fca ............................................................................. 427 b. political climate ripe for increased legislation........... 428 b. the effect of continued fca expansion on the pharmaceutical industry .......................................................... 429 c. the federal government needs to refocus its off-label enforcement efforts ................................................................. 431 iv. conclusion .................................................................................. 433 i. introduction on september 2, 2009, the department of justice announced the largest health care fraud settlement in united states history. pfizer, one of the world’s largest pharmaceutical companies, along with its subsidiary, pharmacia & upjohn company, inc., (“pfizer”) agreed to pay the federal government $2.3 billion in civil and criminal fines to resolve liability involving the illegal promotion of its pharmaceutical products.2 although pfizer’s liability stemmed from its promotion of four different pharmaceuticals, the company’s most egregious offense was the promotion of its antiinflammatory drug, bextra.3 when pfizer sought approval of bextra in 2001, the fda was only willing to approve the drug for a few specific uses.4 most notably, the fda 2. press release, u.s. dep’t. of justice, justice department announces largest health care fraud settlement in its history-pfizer to pay $2.3 billion for fraudulent marketing (sept. 2, 2009), available at http://www.fbi.gov/pressrel/pressrel09/justice_ 090209.htm [hereinafter pfizer press release]. 3. id. 4. see united states’ sentencing memorandum at 5, united states v. pharmacia & upjohn co., no. 09-cr-10258-dpw (d. mass. oct. 9, 2009) (providing that the fda approved bextra for treatment of osteoarthritis, adult rheumatoid arthritis, and primary dysmenorrheal but “specifically declined to approve [bextra’s] use for general acute pain, the 2011] federal government expands its use of the false claims act 401 declined to approve bextra for the treatment of acute pain due to safety concerns following a study of patients who were given bextra after they underwent coronary artery bypass surgery.5 the results of the study indicated that there were an “excess of serious cardiovascular thromboembolic events,” or blood clots, after bextra was administered to the patients.6 however, despite the fda’s specific disapproval, pfizer engaged in an elaborate marketing scheme to sell bextra for its unapproved uses, particularly its use for acute pain, from 2002 through 2005.7 some of the marketing techniques that pfizer used to promote bextra included the following: unsolicited medical information was sent to physicians about unapproved uses, samples of the drug were sent to surgeons who had no fda-approved use for the drug, pfizer sponsored “independent” medical education programs about unapproved uses, and pfizer distributed to its sales force explicit instructions on how to promote the drug during sales calls to physicians.8 pfizer continued to promote bextra for unapproved uses until it voluntarily pulled the drug from the market in 2005, at the fda’s request.9 pfizer’s behavior with regard to its promotion of bextra is known as “off-label” promotion, which occurs when a pharmaceutical company promotes its products for uses not approved by the fda.10 pharmaceutical manufacturers are generally prohibited from promoting their pharmaceutical products for off-label uses.11 however, because physicians are permitted to prescribe drugs for on-label and off-label uses, pharmaceutical manufacturers have an incentive to inform physicians about all of the possible uses of their products in order to increase sales.12 therefore, when pfizer promoted bextra for off-label use, it risked legal culpability in order to reap the benefits of increased sales of the drug. in the end, pfizer paid a monumental price for its decision to engage in off-label promotion. preemption of the pain of surgery, and opioid sparing.”). 5. id. 6. id. 7. id. at 8. 8. id. 9. id. 10. pfizer press release, supra note 2. 11. the fda has established guidance documents that pharmaceutical manufacturers should follow when disseminating information about off-label uses of their pharmaceuticals. although the general rule is that no pharmaceutical manufacturer can promote off-label uses, the guidance documents provide a few exceptions to this general prohibition. this issue will be discussed more extensively in section ii of this note. see generally office of the commissioner, good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices, u.s. food and drug administration, http://www.fda.gov/regulatoryinformation/guidances/ucm125126.htm (last updated aug. 6, 2009) [hereinafter good reprint practices]. 12. see 21 u.s.c. § 353(b)(2) (2009); see also 21 u.s.c. § 396 (2009). 402 indiana health law review [vol. 8:2 a. the issue pfizer does not stand alone within the pharmaceutical industry in its decision to engage in off-label promotion. in fact, the practice seems to be commonplace.13 although many other pharmaceutical manufacturers have settled claims involving off-label drug promotion recently, the magnitude of the pfizer settlement demonstrates the seriousness of the federal government’s enforcement efforts and its commitment to change this widespread behavior.14 the sources of federal law that served as the basis for pfizer’s offlabel marketing liability were the federal food, drug, and cosmetic act (“fdca”) and the false claims act (“fca”).15 while the fdca has traditionally been used to regulate illegal off-label marketing behavior, the use of the fca as an additional legal tool to police the same behavior has only recently emerged.16 attaching fca liability to off-label marketing has not only made it possible for the department of justice (“doj”) to pursue the pharmaceutical industry for putting the public’s health at risk, but it has now permitted the doj to pursue the pharmaceutical industry with a justification that it is protecting the american taxpayers from health care fraud.17 the doj is no exception in its recent enforcement efforts under the fca; in fact, all three branches of federal government have embraced this new theory of off-label promotion liability and have played some role in expanding the scope of the fca. the federal government has recently shifted from the traditional regulatory approach, with regard to off-label promotion by the pharmaceutical industry, to an enforcement and punishment approach. currently, the government’s focus seems to be more on punishing fraud than on balancing the risks and benefits of pharmaceuticals on the public health.18 no one can deny the federal government’s strong interest in preventing a company’s bottom line, as in the case of pfizer, from taking priority over the public’s health and safety. however, it is also necessary to hold the government accountable for overreaching their policing abilities. recently, in the name of fraud, the federal government has rigorously pursued the pharmaceutical industry by attaching fca liability to off-label promotion, despite the existence of the regulatory framework already in place to prevent this behavior. 13. see top 20 cases, taxpayers against fraud education fund, http://www.taf.org/ top20.htm [hereinafter top 20] (last visited feb. 22, 2011). 14. see id.; see also pfizer press release, supra note 2 (discussing the significance of the landmark pfizer settlement). 15. id.; see also the federal food, drug, and cosmetic act, 21 u.s.c. §§ 301-399 (2009); the false claims act, 31 u.s.c. §§ 3729-3733 (2009). 16. see generally top 20 cases, supra note 13. 17. pfizer press release, supra note 2. 18. see, e.g., west, supra note 1. 2011] federal government expands its use of the false claims act 403 b. roadmap this note examines the recent enforcement efforts surrounding offlabel promotion in the pharmaceutical industry. section ii of this note explores the regulatory and enforcement background in the off-label context, and begins by taking a look at the federal law that serves as the basis for off-label marketing liability, specifically, the fdca. additionally, section ii explores the past enforcement efforts by the federal agency charged with regulating off-label promotion under the fdca, the fda. section ii also introduces the basic elements of the fca and shows how this federal antifraud statute has been used to impose liability on the pharmaceutical industry for off-label promotion. section iii of this note demonstrates the fca’s recent expansion as applied to off-label promotion, and also shows how each branch of our federal government has contributed to the fca’s expansion in the off-label context. additionally, section iii examines how the expansion of the fca will likely affect the pharmaceutical industry and demonstrates that the fca is not the most appropriate tool at the federal government’s disposal when it comes to policing off-label promotion. finally, section iii proposes that the federal government should leave offlabel regulation to the agency that is best equipped to balance the public’s health and safety interests, the fda. a brief conclusion is presented in section iv. ii. background: a look into the history surrounding regulation of off-label promotion a. regulating off-label promotion under the fdca on june 24, 1938, franklin d. roosevelt signed the fdca into law.19 the fdca’s purpose is to protect the health of the public by preventing adulterated or misbranded drugs from entering into interstate commerce.20 in 1938, congress put the fda in charge of a mandatory pre-market approval process for all new pharmaceutical products pursuant to the fdca.21 the fda remains responsible for conducting the pre-market approval process for prescription pharmaceutical products and is also responsible for 19. 21 u.s.c. §§ 301-399. the act’s passage was a response to public concern over a health crisis that occurred in 1937, when a tennessee company marketed an untested “wonder drug” that resulted in over 100 deaths, many of them children. see fda history-part ii, u.s. food and drug administration, http://www.fda.gov/aboutfda/ whatwedo/ history/origin/ucm054826.htm (last updated june 18, 2009) [hereinafter, fda’s origin] (last updated june 18, 2009). 20. see kordel v. united states, 335 u.s. 345, 349 (1948); 21 u.s.c. § 331 (2009). 21. 21 u.s.c. §§ 301-399. 404 indiana health law review [vol. 8:2 overseeing drug marketing and labeling practices by the pharmaceutical industry.22 1. the fda’s new drug approval process the fdca provides that “no person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed . . . is effective with respect to such drug.”23 therefore, before a drug may be sold or marketed in the united states, the fda must approve that drug’s new drug application (“nda”).24 but even before a drug manufacturer submits the nda, the new drug must be approved for clinical trials.25 in other words, the drug manufacturer must prove that its drug is safe for human testing by obtaining pre-approval of its drug as an investigational new drug (“ind”).26 after ind approval and the subsequent clinical trials take place, the manufacturer is required to submit, through the drug’s nda, various information about the new drug such as: reports of investigations that show whether the drug is safe and effective for use, components of the drug, a statement about the composition of the drug, a description of the manufacturing, processing, and packaging methods, samples of the drug, and proposals for the labeling of the drug.27 as part of the nda evaluation process, fda officials determine whether the potential benefits of the new drug will justify the possible safety risks of the drug.28 in essence, the fda engages in a cost/benefit analysis when deciding whether to approve a drug for entry into the market. if the benefits to the public health outweigh the risks, then the drug will be approved for the market, and the fda will also get a say in what specific warnings or dosages go on the new drug’s label.29 once the fda approves the new drug for introduction into interstate commerce, additional uses for the drug may not be added to that drug’s label without submitting another nda, a supplemental application for that 22. 21 u.s.c. § 355 (2010). 23. 21 u.s.c. § 355(a). 24. id.; richard c. ausness, “there’s danger here, cherie!” liability for the promotion and marketing of drugs and medical devices for off-label uses, 73 brook. l. rev. 1253, 1256 (2008). 25. 21 c.f.r. §§ 312.1-312.320 (2010); about fda: what is the approval process for a new prescription drug?, u.s. food and drug administration, http://www.fda.gov /aboutfda/transparency/basics/ucm194949.htm (last updated jan. 5, 2010). 26. see generally, 21 c.f.r. §§ 312.1-312.320 (2010). 27. 21 u.s.c. § 355(b)(1). 28. rebecca dresser & joel frader, off-label prescribing: a call for heightened professional and government oversight, 37 j.l. med. & ethics 476, 477 (2009). 29. the fda’s drug approval process: ensuring drugs are safe and effective, u.s. food and drug administration, http://www.fda.gov/drugs/resourcesforyou/ consumers/ucm143534.htm (last updated feb, 22, 2010). 2011] federal government expands its use of the false claims act 405 drug.30 therefore, a drug manufacturer must go through much of the drug approval process again in order to get approved for a new use of the drug. because the new drug approval process is lengthy—estimates show that the average “time from the start of clinical testing to marketing approval [is] . . . 90.3 months”—many pharmaceutical manufacturers have figured out ways to circumvent the process.31 also, if the drug is already on the market and being prescribed by physicians, and the only purpose of submitting a supplemental new drug application is for the ability to market the existing drug for a new use, a pharmaceutical company is unlikely to spend the money and time on the application.32 in other words, “[i]f an off-label use is already well known among physicians, adding it to the label would likely have little effect on sales.”33 2. what is an off-label use? although there is no explicit statutory definition of an off-label use, the term “off-label” takes root in the fdca.34 because the fdca mandates fda approval of a drug’s specific use and additionally requires that such use be accurately reflected on the drug’s label, a drug is used off-label when that use has not been approved by the fda.35 however, the fdca specifically exempts physicians from the labeling and prescription requirements that apply to drug manufacturers.36 therefore, physicians are permitted to write prescriptions to patients for off-label use of a drug, without penalty under the fdca.37 in fact, physicians take advantage of the exception, as it is estimated that between twenty-five to sixty percent of all prescriptions are written for off-label uses.38 an example of an off-label use would be if a physician treated a patient for acute pain with pfizer’s drug, bextra. the fda never specifically approved bextra for the treatment of acute pain; therefore, the use of bextra to treat acute pain would be considered an off-label use. 30. 21 c.f.r. §§ 314.54 and 314.70 (2010). 31. joseph a. dimasi, et al., the price of innovation: new estimates of drug development costs, 22 j. health & econ. 151, 164-5 (2003). see also, kaspar j. stoffelmayr, comment, products liability and “off-label” uses of prescription drugs, 63 u. chi. l. rev. 275, 277 (1996). 32. see generally j. howard beales, iii, economic analysis and the regulation of pharmaceutical advertising, 24 seton hall l. rev. 1370 (1994). 33. stoffelmayr, supra note 31, at 277. 34. 21 u.s.c. §§ 301-399 (2009). 35. stephanie greene, false claims act liability for off-label promotion of pharmaceutical products, 110 penn. st. l. rev. 41, 46 (2005). 36. 21 u.s.c. § 353(b) (2009). 37. id. 38. nathan cortez & robert litt, trends in criminal enforcement against off-label promotion, the american bar association’s 21st annual national institute on white collar crime, l-23 to l-33 (2007). 406 indiana health law review [vol. 8:2 3. violating the fdca through off-label promotion there are several different types of promotional activities employed by the pharmaceutical industry to boost a drug’s sales, including: professional journal advertisements, magazine and newspaper advertisements, brochures, product giveaways, presentations at conferences, continuing medical education seminars, or company-sponsored events, oral statements by sales representatives during hospital visits, and many more.39 if a pharmaceutical manufacturer is promoting its products for fda-approved uses, then these promotional activities are perfectly legitimate. however, as soon as the manufacturer promotes products for an off-label use, the marketing practices become illegitimate.40 to clarify, there are two main ways that a drug manufacturer may violate the fdca through its off-label promotion of a pharmaceutical product. the first type of violation occurs when a drug that was previously approved for certain uses, is promoted for other non-fda approved uses, as the drug is effectively an unapproved “new drug” under the fdca.41 the “fda sees off-label promotion as the equivalent of introducing an unapproved new drug into interstate commerce in violation of the fdca.”42 in essence, the fda regards the off-label promotion of non-approved drug uses as if the pharmaceutical manufacturer skipped the nda process altogether. second, the fda may hold a drug manufacturer liable for off-label promotion of a drug as a misbranding violation under the fdca.43 because the fda approves each drug’s particular label for certain uses and dosages during the nda process, when a drug is promoted for a use other than the use on the label, the drug is considered misbranded.44 pharmaceutical companies that introduce unapproved new drugs or misbranded drugs into interstate commerce can face civil and criminal penalties under the fdca.45 pfizer, for example, was held liable for misbranding the drug bextra,46 and consequently, had to pay a fine of $1.195 billion, the largest criminal fine ever imposed in our nation’s history.47 39. michelle m. mello et al., shifting terrain in the regulation of off-label promotion of pharmaceuticals, 360 new eng. j. med. 1557, 1557 (2009). 40. but see good reprint practices, supra note 11 (discussing certain permitted offlabel communications); see also infra section ii(a)(5). 41. id.; 21 u.s.c. §§ 321(p), 331(d), 355(a)(2009). 42. cortez & litt, supra note 38. 43. 21 u.s.c. § 331(b)(2009); 21 u.s.c. § 352 (2007). 44. 21 u.s.c. § 352; see also, generally vicki w. girard, punishing pharmaceutical companies for unlawful promotion of approved drugs: why the false claims act is the wrong rx, 12 j. health care l. & pol’y 119 (2009). 45. 21 u.s.c. § 333 (2009). 46. pfizer press release, supra note 2. 47. in total, pfizer and its subsidiary, pharmacia & upjohn, paid a criminal fine of $1.3 billion in order to resolve criminal fdca violations. this figure is one part of the total $2.3 billion pfizer settlement amount. see pfizer press release, supra note 2. 2011] federal government expands its use of the false claims act 407 4. is off-label marketing problematic? there are benefits and risks associated with both off-label use and offlabel marketing. with respect to off-label use, experts in the legal and medical communities are divided on whether the practice should be more or less regulated.48 concerning marketing, there are critics that contend the fda should loosen regulation.49 being that there are strong public policy arguments on both sides of these issues, the fda is put in a difficult position. it is the fda’s responsibility to look out for the public’s health while balancing the benefits of off-label use. therefore, the fda must walk a fine line when making decisions associated with off-label use and marketing. the agency must encourage the innovation needed to cure diseases and save lives, while also minimizing the risks associated with drugs that have not been rigorously tested for safety and effectiveness. a. benefits of off-label use and marketing many feel that off-label drug use is essential to providing patients with optimal medical care.50 also, “because the pace of medical discovery runs ahead of the fda’s regulatory machinery, the off-label use of some drugs is frequently considered to be “state-of-the-art” treatment.”51 thus, many feel that it is extremely beneficial to employ off-label uses of pharmaceuticals. patients with terminal illnesses often depend on the innovative use of pharmaceuticals already on the market, especially when other drugs have failed to provide a cure during the course of their treatment.52 it is only logical that, for example, in the field of oncology, if one drug proves to be effective for a certain type of cancer, the drug may prove to be effective for another type.53 even if the drug is not approved for the latter type of cancer, the patient would likely prefer to use that drug off-label rather than wait for the manufacturer to submit an nda, because, after all, that patient will likely not have time to wait. also, doctors tend to off-label prescribe for “socalled orphan populations and orphan diseases—populations too small and diseases too rare to justify the expense of petitioning the fda for new la 48. tracy hampton, experts weigh in on promotion, prescription of off-label drugs, 297 jama 683, 683-84 (2007). 49. alexander t. tabarrok, assessing the fda via the anomaly of off-label drug prescribing, 5 the indep. rev. 25, 48 (2000). 50. james m. beck & elizabeth d. azari, fda, off-label use, and informed consent: debunking myths and misconceptions, 53 food & drug l.j. 71, 72 (1998). 51. maxwell j. mehlman, off-label prescribing, the doctor will see you now (may 1, 2005), http://www.thedoctorwillseeyounow.com/content/art1971.html (quoting richardson v. miller, 44 s.w.3d 1, 13 (tenn. ct. app. 2000)). 52. tabarrok, supra note 49, at 28. 53. hampton, supra note 48, at 683. 408 indiana health law review [vol. 8:2 beling.”54 besides oncology, patient care in the medical fields of pediatrics, psychiatry, geriatrics, obstetrics, and many others, “could not proceed if offlabel prescribing did not occur.”55 furthermore, the fdca explicitly authorizes physicians to prescribe drugs for off-label uses.56 this explicit authorization is direct evidence that our legislature views off-label use as appropriate and necessary in many contexts.57 promotion of off-label uses is also recognized as being very important for the pharmaceutical industry. the main benefit associated with the practice of off-label promotion “is to inform the health care community about scientific advances that will benefit patients, thus improving the quality of health care without waiting for the lengthy fda approval process.”58 ensuring that the medical community has up-to-date information about existing drugs that may be beneficial in the treatment of known ailments is a compelling reason to allow pharmaceutical companies to promote their unapproved products. also, because the medical professional is the ultimate decision-maker when it comes to prescribing a drug for an off-label use, it seems harmless to inform them about potential off-label uses.59 the research and development that pharmaceutical companies perform is crucial to the progress of health and medical science. there is an undeniable benefit of disseminating information about possible curative drugs to physicians as well as the public. however, while society may try to give pharmaceutical companies the benefit of the doubt when it comes to producing safe and effective drugs as well as providing truthful information about those drugs, it cannot ignore the fact that pharmaceutical companies are also accountable to their shareholders for earning a profit.60 54. tabarrok, supra note 49, at 28. 55. dresser & frader, supra note 28, at 476. many drugs are not tested on certain groups of individuals (for example, children and pregnant women) and as a result, are not approved for safe use on these populations. as a consequence, children, pregnant women, or older individuals must use the drug off-label in order to benefit from several types of drugs. this does not necessarily mean that the drug is unsafe for use on these populations, but that the use is not approved by the fda. see american academy of pediatrics, committee on drugs, uses of drugs not described in the package insert (off-label uses), 110 pediatrics 181 (2002). see also, ausness, supra note 24, at 1254-55. however, also note that “the fda have claimed to be speeding up and simplifying the supplemental approval process, especially with regard to the most significant “orphan” population, children. tabarrok, supra note 49, at 28. 56. 21 u.s.c. § 353(b) (2004). 57. id. 58. greene, supra note 35, at 47. 59. see hampton, supra note 48, at 683. 60. see marcia angell, the truth about the drug companies: how they deceive us and what to do about it 3 (random house trade paperbacks, 2005) (noting that “[the pharmaceutical industry] has consistently ranked as the most profitable in the united states” and that “[the pharmaceutical industry earns] more than $200 billion a year.”). 2011] federal government expands its use of the false claims act 409 b. risks associated with off-label use and marketing it is a risky practice to distribute pharmaceuticals to the public without ensuring that the products are safe and effective for the condition they will be used to treat. as mentioned earlier, the fda engages in a cost/benefit analysis when it approves drugs for particular uses. however, the problem with off-label use is that the drug did not have an opportunity to go through the fda’s formal analysis to determine safety and efficacy for a particular condition. the approval safeguards associated with drugs that have undergone the nda process are not present when a physician prescribes a drug for an off-label use. while the fda assumes physicians will ensure that an off-label use is generally accepted within the medical community before writing a prescription, “appropriate off-label prescribing can be challenging for physicians today, because of time pressures, information overload, and the involvement of industry in research and development about off-label uses.”61 a 2009 study on u.s. physician knowledge of fda-approved indications discovered that “many u.s. physicians may lack adequate knowledge of the fda-approved indications of drugs they prescribe” and “a significant minority [of u.s. physicians] also prescribes some drugs for off-label indications, in the belief that they are approved for such uses, despite uncertain or no supporting evidence.”62 another study of off-label use by private practice physicians reported that only twenty-seven percent of off-label uses were supported by strong scientific evidence of clinical efficacy.63 compared to off-label use, the risks associated with off-label promotion by pharmaceutical companies are more obvious, given the companies’ interest in selling their products. the fdca was originally enacted to protect the public from purchasing unsafe products and to keep businesses from marketing dangerous, untested drugs.64 in the past, pharmaceutical companies have been caught engaging in unethical and illegal off-label marketing practices.65 these companies tend to take advantage of the fact that physicians are busy people that may not have the time to seek out credible resources regarding off-label uses. one can guess that pharmaceutical companies hope that physicians will simply rely on the pharmaceutical sales representatives’ assertions, or assume that the off-label research presented to them is unbiased and credible.66 for example, pfizer’s illegal 61. dresser & frader, supra note 28, at 476. 62. donna t. chen et al., u.s. physician knowledge of the fda-approved indications and evidence base for commonly prescribed drugs: results of a national survey, 18 pharmacoepidemiology & drug safety 1094, 1099 (2009). 63. hampton, supra note 48, at 683. 64. fda’s origin, supra note 19. 65. see top 20, supra note 13. 66. see, e.g., united states’ sentencing memorandum, supra note 4. 410 indiana health law review [vol. 8:2 marketing scheme for the sale of bextra, previously discussed in section i, centered on influencing physicians to prescribe bextra for its off-label uses.67 c. defining acceptable promotion practices before 1997, all off-label marketing attempts by the pharmaceutical industry were prohibited.68 any attempts by a pharmaceutical manufacturer to discuss off-label uses with medical professionals, or to distribute written promotional materials to the medical community, were prohibited.69 only when a physician solicited off-label use information did the fda allow a manufacturer to disseminate that information.70 however, the food and drug modernization act of 1997 (“fdama”) changed the fda’s prior position of prohibiting pharmaceutical manufacturers from off-label marketing.71 the fdama amended the fdca to allow “drug . . . manufacturers to disseminate certain written information on a use of a product that is not described in the product's approved labeling to health care practitioners . . .”72 the fdama provided that, in order to distribute off-label information, a pharmaceutical company must file with the fda “[a] supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use.”73 under the fdama, pharmaceutical manufacturers could send certain journal article reprints to physicians and discuss unapproved uses of drugs during continuing medical education seminars as long as the seminars were independent and not controlled or sponsored by the pharmaceutical company.74 through the fdama, the fda seemed to reach a balance between allowing for the dissemination of beneficial educational information on offlabel uses to the medical community, while ensuring that off-label promotional activities were still regulated. however, this balance expired on september 30, 2006, due to the fdama’s sunset provision.75 upon expiration of the fdama, the fda subsequently issued “good reprint practices,” a 67. id. see also, pfizer press release, supra note 2. 68. greene, supra note 35, at 49. 69. id. 70. id. 71. testimony on the implementation of the fda modernization act of 1997 by michael a. friedman, m.d.: hearing before the h. comm. on commerce, 105th cong. (1998) [hereinafter fdama testimony] (citing statements by michael a. friedman, m.d., acting commissioner, food and drug administration, u.s. department of health and human services). 72. id.; food and drug administration modernization act of 1997, pub. l. no. 105115, § 401, 111 stat. 2296, 2356 (1997) (codified as amended at 21 u.s.c. § 355 et seq. (2000)). 73. fdama testimony, supra note 71. 74. greene, supra note 35, at 49. 75. good reprint practices, supra note 11. 2011] federal government expands its use of the false claims act 411 set of guidance documents on dissemination of off-label educational materials, in order to fill the regulatory gap that the fdama left behind.76 because the fda recognizes “the public health value to healthcare professionals of receiving truthful and non-misleading scientific and medical information . . .” the agency thought it was important to continue to allow guided dissemination of off-label information.77 under the current good reprint practices guidelines, issued on january 13, 2009, the fda relaxes off-label restrictions even further than congress did under the fdama.78 first, the guidelines are just that – guidelines. although issued by an administrative agency, they are nonbinding and are emphasized as such in the language of the guidelines.79 next, submission of a supplemental new drug application is no longer required if a company decides to promote an off-label use.80 finally, the fda does not require the pharmaceutical manufacturer to submit its promotional materials prior to their distribution to the medical community.81 although the fda’s current approach to off-label regulation is more relaxed than in the past, the current guidelines still only permit dissemination of journal articles and scientific reference publications that adhere to the fda’s specifications.82 although off-label promotion is allowed in certain contexts, it is still prohibited in many other contexts. therefore, sending out promotional samples at dosages not approved by the fda would still be considered off-label promotion. the fda has met much criticism regarding its new guidelines, as some critics argue that the guidelines “could possibly harm public health by allowing manufacturers a back door for putting products into the health care setting for unapproved uses without having to . . . gain fda approval.”83 furthermore, many believe that the fda is ineffective in its regulation of off-label promotion in general.84 because the fda’s off-label guidelines only address written promotional materials, other promotional practices go undetected, for example, when pharmaceutical sales representatives inap 76. id.; ausness, supra note 24, at 1261 (discussing fda’s issuance of a version of good reprint practices in 2008, with new guidelines recently issued on january 13, 2009). 77. § 401, 11 stat. 2296, 2356-65; good reprint practices, supra note 11. 78. good reprint practices, supra note 11; theresa defino, new guidelines on distributing literature on off-label indications, neurology today, mar. 5, 2009, at 14, 15. 79. randall s. stafford, regulating off-label drug use rethinking the role of the fda, 358 new eng. j. med. 1427 (2008). 80. id. 81. id. 82. see good reprint practices, supra note 11. 83. mike mitka, critics say fda’s off-label guidance allows marketing disguised as science, 299 jama 1759 (2008); stafford, supra note 79, at 1427. 84. see u.s. gov’t accountability office, report to the ranking member, committee on finance, u.s. senate, gao-08-835, prescription drugs: fda’s oversight of the promotion of drugs for off-label uses (2008), available at http://www.gao.gov/new.items/d08835.pdf. 412 indiana health law review [vol. 8:2 propriately discuss off-label uses with physicians.85 whether the fda has made a conscious decision not to pursue certain types of off-label promotional activity or is unable to detect the majority of off-label promotional activities due to limited resources, there are distinct regulatory gaps when it comes to the fda’s detection of off-label promotion.86 b. regulating fraud and off-label promotion through the false claims act also known as the “lincoln law,” congress passed the fca in 1863 after pressure from president abraham lincoln “to combat profiteering by union army suppliers during the civil war.”87 the fca has since become the federal government’s primary tool for combating fraud.88 generally speaking, the fca prohibits false or fraudulent claims from being submitted to the government in order to procure government payment.89 additionally, the fca “provides an alternative strategy” to the fdca to combat off-label promotion.90 many view the fca as “the single most important tool u.s. taxpayers have to recover the billions of dollars stolen through fraud by u.s. government contractors every year.”91 1. noteworthy provisions of the fca although there are many facets of the fca, there are a few provisions particularly relevant to this note. a. qui tam provision the fca has a “qui tam” provision, also commonly referred to as a “whistleblower” provision.92 this qui tam provision enables private citizens to bring claims on behalf of the federal government.93 a citizen who 85. id. at 6. 86. see id. see also mello et al., supra note 39; stafford, supra note 79, at 1429. 87. united states ex. rel. stephens v. tissue science laboratories, inc., 664 f.supp.2d 1310, 1315 (n.d. ga. 2009) (citing united states ex. rel. williams v. nec corp., 931 f.2d 1493, 1496-97 (11th cir. 1991)); larry d. lahman, bad mules: a primer on the federal false claims act, 76 okla. b.j. 901, 901 (2005). 88. 31 u.s.c. §§ 3729-3733 (2006); greene, supra note 35. 89. stephens, 644 f.supp.2d at 1315 (quoting u.s. ex. rel. williams, 931 f.2d 1463 at 1496). 90. george s. craft, jr., comment, promoting off-label in pursuit of profit: an examination of a fraudulent business model, 8 hous. j. health l. & pol’y 103, 112 (2007). 91. why the false claims act: what is the false claims act and why is it important?, taf education fund, http://www.taf.org/whyfca.htm [hereinafter why the false claims act?] (last visited feb. 22, 2011). 92. 31 u.s.c. § 3730(b)(1). 93. id. 2011] federal government expands its use of the false claims act 413 brings a suit on behalf of the government is known as a qui tam “relator.” section 3730 of the fca provides: “a person may bring a civil action for a violation of section 3729 for the person and for the united states government. the action shall be brought in the name of the government.”94 in a qui tam action, the relator stands to personally recover anywhere between fifteen and thirty percent of the proceeds of the action or settlement of the claim.95 this “encourag[es] individuals who are either close observers or involved in the fraud to report the alleged wrongdoing.”96 this qui tam provision is enormously effective at exposing fraudulent activity that may be too discrete for the federal government to notice. for example, the pfizer settlement was ignited when several qui tam relators came forward to report the fraudulent activity that was a part of the company culture at pfizer.97 because pfizer decided to settle with the federal government, the qui tam relators that were involved in the suit recovered over $102 million dollars.98 john kopchinski, a former pfizer sales representative, was the highest paid relator in the settlement with a share of $51.5 million.99 this payment was, in effect, compensation to mr. kopchinski for putting his career on the line in order to report his ex-employer’s actions of defrauding the government through off-label marketing practices.100 b. possibility of government intervention after a qui tam relator brings a suit on behalf of the government, the government has an opportunity to intervene in the litigation.101 by intervening in the suit, the government will resume responsibility for the litigation.102 the qui tam relator is permitted to remain a party to the suit; however, the government is not bound by any act of the qui tam relator after intervention occurs.103 this qui tam provision benefits relators because he or she will still have the opportunity to recover a percentage of any amount retrieved by the government in the litigation, but will not incur the litigation costs that he or she otherwise would have incurred absent the government’s intervention.104 furthermore, government intervention usually leads to settlement in the off 94. id. 95. see 31 u.s.c. § 3730(d)(1)-(2). 96. kenyanna m. scott & catharine l. du bois, new risk from off-label promotional activity, n.y.l.j., dec.12 2007, at 12. 97. pfizer settles largest false claims act case ever, taf education fund (sep. 2, 2009) http://www.taf.org/whistle253.htm. 98. id. 99. id. 100. see generally why the false claims act, supra note 91. 101. 31 u.s.c. § 3730(a). 102. 31 u.s.c. § 3730(c)(1). 103. id. 104. see 31 u.s.c. § 3730. 414 indiana health law review [vol. 8:2 label context because of the government’s ability to threaten a manufacturer with exclusion from government reimbursement programs.105 a drawback to this provision, however, is that the government is required to investigate all qui tam actions brought by relators.106 the government thus has discretion to dismiss the qui tam relator’s action after their investigation.107 by involving the government, a qui tam relator can either greatly benefit from the government’s intervention or risk losing the suit entirely. c. threat of treble damages. another noteworthy provision of the fca is the treble damages provision.108 if a person or an entity violates the fca, they are “liable to the united states government for a civil penalty of not less than $5,000 and not more than $10,000, plus three times the amount of damages which the government sustains because of the act of that person.”109 further, the fines are assessed for each individual fraudulent claim.110 the threat of treble damages is one likely reason that many fca cases are settled out of court. 2. applying the fca to off-label promotion the fca has undergone several amendments since its inception in the nineteenth century. while past amendments have limited the scope of the fca, amendments in the past three decades have broadened its scope. in 1986, congress amended the fca with the aim of “retooling [the act] as an instrument capable of rooting out government fraud, particularly in defense as well as healthcare spending.”111 the 1986 amendments to the fca increased the qui tam relator’s potential share of the recovery, increased the penalties per fca violation, and added the treble damages provision.112 since 1986, false claims suits against the health care industry have risen drastically.113 as stated earlier in this note, the fca has become an additional enforcement tool used by the federal government to pursue off-label promotion violations. however, it is important to address the reasoning behind why off-label promotion creates fca liability, especially considering that 105. the threat of exclusion will be discussed further in section iii of this note. 106. 31 u.s.c. § 3730(a). 107. 31 u.s.c. § 3730(c)(2)(a). 108. 31 u.s.c. § 3729(a)(1) (2006). 109. id. 110. scott & du bois, supra note 96. 111. edward p. lansdale, note, used as directed? how prosecutors are expanding the false claims act to police pharmaceutical off-label marketing, 41 new eng. l. rev. 159, 170 (2006). 112. id. 113. see top 20, supra note 13. 2011] federal government expands its use of the false claims act 415 the term “off-label” takes root in the fdca, and the consequences for promoting pharmaceutical products for off-label uses are provided for under the fdca.114 so, how do prosecutors tie the practice of off-label promotion to liability under this federal fraud statute? pharmaceutical manufacturers depend a great deal on government reimbursement programs like medicare and medicaid to pay for sales of their prescription drugs.115 under the fca, if a pharmaceutical manufacturer causes the federal government to pay a false claim under medicare, for example, as a result of their off-label marketing practices, the fca may be used as a tool to recover the money that the government paid out to the manufacturer.116 in the history of regulating off-label promotion through the fca, two legal arguments are usually made in order to attach liability to pharmaceutical manufacturers.117 one theory of liability under the fca is to hold pharmaceutical companies “liable for making false claims about [their] drug.”118 certain offlabel uses are prohibited from reimbursement under federally funded government health care programs.119 therefore, under this first theory, if a pharmaceutical sales representative make an untrue claim regarding the safety and effectiveness of their product to a physician, which in turn leads that physician to bill a federally-funded government health care program, such as medicare, for reimbursement of that off-label use for their patient, then this action has the effect of causing a false claim to be made to the federal government. a second, relatively new theory under the fca was announced in the parke-davis case.120 if a pharmaceutical company’s aggressive marketing eventually causes a party to improperly bill medicaid, then that pharmaceutical company can be liable under the fca.121 the parke-davis case held that: [a qui tam] relator is not required to present evidence that [the pharmaceutical company] lied to physicians about [the drug’s] off-label efficacy or safety to induce them to prescribe [the drug] for uses ineligible under medicaid. . . . truthful off-label marketing . . . 114. see generally 21 u.s.c. §§ 301-399 (2006). 115. see, e.g., scott & du bois, supra note 96. 116. greene, supra note 35, at 54 (citing 31 u.s.c. § 3729(a)(1) (2005)). 117. lansdale, supra note 111, at 161. 118. id. 119. see, e.g., 42 u.s.c. § 1396r-8 (2006). 120. see united states ex. rel. franklin v. parke-davis, 147 f. supp. 2d 39, 51 (d. mass 2001); lansdale, supra note 111, at 161. 121. lansdale, supra note 111, at 161. 416 indiana health law review [vol. 8:2 and financial incentives like kickbacks would suffice.122 therefore, liability under the fca can arise when pharmaceutical manufacturers promote off-label uses of their products, even when the statements are credible, knowing that the federal government will reimburse the physician who prescribed its products. using the fca as a tool to regulate behavior in the pharmaceutical industry has become much more common in the last decade.123 federal prosecutors are thus pursuing pharmaceutical manufacturers under the fca after the manufacturer violates the fdca. as mentioned earlier, the fda seems to lack the ability to police certain “off the record” instances of offlabel promotion. the qui tam provision gives insiders in the pharmaceutical industry the ability to police the off-label practices that the fda cannot detect. however, critics wonder whether it is reasonable to attach fca liability upon the pharmaceutical industry when the off-label marketing behavior is so loosely connected to the language of the statute and also, when off-label marketing is already specifically regulated by the fdca.124 whether one agrees or disagrees with the fca’s use in the off-label context, the reality is that the three branches of our federal government have all contributed to the gradual increase of the pharmaceutical industry’s liability under the fca. iii. analysis: taking a look at the pharmaceutical industry’s liability for off-label marketing as the scope of federal enforcement continues to expand through the false claims act a. the expansion of the false claims act as stated previously, the fca has recently been used as an enforcement tool to police the practice of off-label marketing by the pharmaceutical industry. while the health care industry has been subject to fca liability in the past, theories of potential liability related to off-label promotion by pharmaceutical manufacturers have only developed within the twenty-first century.125 this emerging method of targeting off-label marketing 122. id. (quoting judge patti saris in united states ex. rel. franklin v. parke-davis, no. 96-11651, 2003 u.s. dist. lexis 15754 at 4 (d. mass. aug. 22, 2003)). 123. see top 20, supra note 13. 124. see generally girard, supra note 44. 125. robert t. rhoad et al., a gathering storm: the new false claims act amendments and their impact on healthcare fraud enforcement, 21 the health law. 14 (2009); see also ralph f. hall & robert j. berlin, when you have a hammer everything looks like a nail: misapplication of the false claims act to off-label promotion, 61 food & drug l.j. 653 (2006). 2011] federal government expands its use of the false claims act 417 has not only developed quickly, but has flourished126 and the expansion of the fca is now apparent in all three branches of our federal government. while not all expansion efforts are directly related to policing off-label promotion, the widening scope of the fca will surely affect the pharmaceutical industry. and this expansion of fca application continues to occur without thorough judicial consideration of whether its use is really proper in the off-label context. 1. executive expansion of the fca more than any other branch of government, the executive branch has extended the fca’s reach to off-label promotion practices the furthest. the executive department that has primarily contributed to this expansion is the department of justice (“doj”), the federal department responsible for enforcing federal laws. although other federal agencies contribute to the investigative and enforcement efforts related to off-label promotional activities, the doj is the primary enforcement agency for violations of the fca as well as the fdca.127 this was not always the case, however, as in the past the fda exclusively oversaw off-label marketing practices, primarily through a regulatory approach to enforcement.128 a. the doj has the ability to bypass fda’s regulatory authority to enforce federal law there are two ways in which the doj may become involved with offlabel promotional prosecutions. first, the fda can initiate doj’s involvement in the enforcement of off-label promotional violations.129 if the fda decides that its regulatory efforts are not correcting improper off-label promotional behavior by a pharmaceutical company, the fda can refer the violations to the doj for civil or criminal enforcement action.130 as an alternative to adhering to the traditional fda-initiated enforcement method, the doj can also initiate investigations and prosecutions of off-label marketing violations on its own.131 it is through this latter method of enforce 126. see top 20, supra note 13. 127. see, e.g., scott a. memmott & betsy mccubrey, off-label marketing prosecutions and cephalon: the government hits its stride and hits hard, 11 j. health care compliance 55 (2009); see also u.s. gov’t accountability office, supra note 84. although the fda is an administrative agency under the executive branch of our federal government, the fda has not contributed to the expansion of the fca as it relates to off-label promotion. the fda’s regulatory roll takes root under the fdca. 128. john n. joseph et al., enforcement related to off-label marketing and use of drugs and devices: where have we been and where are we going? 2 j. health & life sci. l. 73, 73 (2009). 129. u.s. gov’t accountability office, supra note 84, at 2. 130. id. 131. id. at 19. 418 indiana health law review [vol. 8:2 ment that the doj imposes fca liability on pharmaceutical manufacturers that the fda may not have otherwise imposed. when a pharmaceutical manufacturer decides to market a drug for an off-label use, the fda regulates that manufacturer’s behavior solely through the fdca.132 however, because the doj enforces federal law, the doj can prosecute that same illegal off-label marketing behavior under the both the fdca and the fca.133 therefore, a pharmaceutical manufacturer that is pursued by the doj can be liable for both fdca and fca violations.134 it is disconcerting that the doj’s prosecutorial investigations of pharmaceutical companies for off-label marketing are triggered by violations of the fdca and not the fca. although it is appropriate for the doj to pursue fdca violations, the agency that controls and ensures compliance with the fdca, the fda, is usually not initially involved in the prosecutions.135 basically, the fca claim would not exist if not for a violation of the fdca. although, as discussed earlier, the doj can initiate off-label prosecutions without direction from the fda, it is qui tam relators that usually make the doj aware of a pharmaceutical manufacturer’s off-label marketing practices. because qui tam relators have great monetary incentives for reporting their company’s off-label marketing schemes, off-label suits brought by qui tam relators are extensive.136 after a qui tam relator files suit, the doj will investigate the relator’s allegations and decide whether to intervene in the litigation.137 once the doj decides to investigate a pharmaceutical manufacturer for off-label marketing, the department will usually contact the fda to assist in the investigation and resolution of the suit.138 if the doj does decide to intervene in the qui tam suit, a settlement agreement between the doj, fda, and the accused manufacturer usually follows. therefore, fca suits initiated by qui tam relators are a significant initiator of the doj’s off-label enforcement agenda.139 the use of the fca in the off-label arena has enabled qui tam relators and the doj to take the 132. see 21 u.s.c. §§ 301-399 (2006). 133. the doj enforces off-label marketing behavior through additional federal laws as well, however, a discussion of all of the additional off-label enforcement methods is beyond the scope of this note. 134. see, e.g., pfizer press release, supra note 2. 135. u.s. gov’t accountability office, supra note 84, at 19. 136. 31 u.s.c. § 3730(d)(1) (2006). 137. 31 u.s.c. § 3730. 138. u.s. gov’t accountability office, supra note 84, at 19. 139. see generally michael rich, prosecutorial indiscretion: encouraging the department of justice to rein in out-of-control qui tam litigation under the civil false claims act, 76 u. cin. l. rev. 1233 (2008) (discussing how the fca’s qui tam relator incentives influence the doj when prosecuting fraud under the fca). 2011] federal government expands its use of the false claims act 419 place of the fda when it comes to regulating and enforcing the pharmaceutical industry’s off-label promotion practices. b. steady increase in amount and magnitude of settlements throughout the past decade there has been a steady increase in the magnitude of damages collected through off-label settlements as well as the amount of cases settled for off-label violations.140 the threat of treble damages, mentioned in section ii, is one apparent reason why pharmaceutical manufacturers are unwilling to take a gamble at trial for violating the fca.141 but even beyond this strong deterrent, the doj has another tool at its disposal to encourage settlement of fca claims. this powerful settlement-inducement tool is known as “debarment,” which is the exclusion of a pharmaceutical company or its products from federal government health care reimbursement programs, like medicare and medicaid.142 critics characterize the threat of exclusion, or debarment, from federal reimbursement programs as a “nuclear threat” or a “corporate death sentence” due to the fact that “exclusion can completely choke off a company’s revenue stream by eliminating access to the patients who buy the drugs.”143 as a result, pharmaceutical manufacturers likely see it as imperative to cooperate with federal prosecutors in the doj when this threat is on the table. between 2003 and 2007, the doj has settled at least eleven cases involving off-label marketing allegations against various pharmaceutical companies.144 of these settlements, at least nine involved the imposition of civil monetary fines through the fca.145 for the fiscal year 2009, the doj reported fca recoveries totaling over $2.4 billion.146 this fca recovery amount was the second largest since the expansive 1986 amendments to the fca.147 this increase of the number and magnitude of settlements involving pharmaceutical manufacturers for off-label promotional behavior continues to rise.148 the doj only demonstrates an intention to continue this 140. the false claims act legal center: statistics, taf education fund, http://www.taf.org/statistics.htm [hereinafter taf statistics] (last visited feb. 22, 2011). 141. see 31 u.s.c. § 3729 (2006); hall & berlin, supra note 125, at 676. 142. see 42 u.s.c. § 1320a-7 (2006); hall & berlin, supra note 125, at 676. 143. hall & berlin, supra note 122, at 676; lansdale, supra note 111, at 181. 144. u.s. gov’t accountability office, supra note 84, at 37. 145. taf statistics, supra note 140. 146. fy 2009 false claims act settlements, taf education fund, http://www.taf.org/total2009.htm (last updated oct. 1 2009). 147. joe palazzolo, doj recovers $2.4 billion in false claims act cases, main justice (nov. 19, 2009), http://www.mainjustice.com/2009/11/19/doj-recovers-2-4-billionin-civil-fraud-cases. 148. see, e.g. top 20, supra note 13; see also erica teichert, allergan agrees to plead guilty and pay $600 million to resolve allegations of off-label promotion of botox, fierce pharma (sept. 2, 2010), http://www.fiercepharma.com/press_releases/allergan-agreesplead-guilty-and-pay-600-million-resolve-allegations-label-promotion; see also david voreacos, elan will pay $203 million to settle illegal marketing probe of zonegran, 420 indiana health law review [vol. 8:2 billion-dollar recovery pattern.149 one of the more significant contributing factors of the doj’s large 2009 fiscal recovery under the fca was the landmark pfizer settlement.150 when pfizer settled allegations of off-label promotion in september of 2009, the pharmaceutical giant made health care fraud history with the $2.3 billion settlement figure.151 the pfizer settlement began when several qui tam whistleblowers filed suit under the fca in various federal district courts throughout the united states.152 when the qui tam whistleblowers brought the off-label allegations as well as evidence of those allegations, the doj decided to intervene in the suit. several district attorneys’ offices as well as many federal agencies, including the fda, played a role in investigating the allegations against pfizer.153 this settlement, although initiated by qui tam relators and primarily pursued by federal prosecutors, was resolved through a concerted effort by various interested federal agencies.154 pfizer was accused of violating both the fdca and the fca through its off-label marketing practices.155 of the $2.3 billion settlement figure, $1.3 billion resolved the company’s criminal liability under the fdca and the remaining $1 billion resolved allegations that the company “caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs,” or in other words, resolved potential liability under the fca.156 additionally, $102 million of the federal government’s fca recovery was divided among the six qui tam whistleblowers.157 as mentioned earlier, pfizer’s most serious off-label marketing offenses were related to its pain and anti-inflammatory drug, bextra.158 under the settlement agreement, pfizer agreed to plead guilty to a felony misbranding charge under the fdca for the off-label marketing of bextra.159 pfizer’s off-label marketing behavior with regard to bextra was deliberate. bloomberg (dec. 16, 2010), http://www.bloomberg.com/news/2010-12-15/elan-agrees-topay-203-million-to-settle-u-s-probe-of-zonegran-marketing.html; see also press release, u.s. dep’t of justice, kos pharmaceuticals to pay more than 41 million to resolve kickback and off-label promotion allegations (sept. 2, 2009), available at http://www.justice.gov/opa/pr/2010/december/10-civ-1402.html. 149. see, e.g., effective strategies for preventing health care fraud: hearing before the s. comm. on the judiciary, 111th cong. (2009) [hereinafter west strategies] (statement of tony west, assist. att’y gen. of the united states), available at http://www.justice.gov/dag/testimony/2009/dag-testimony-091028.html. 150. see discussion, supra section i. 151. pfizer press release, supra note 2. 152. id. 153. id. 154. id. 155. id. 156. id. 157. id. 158. see discussion, supra section i. 159. specifically, pfizer was charged with violating 21 u.s.c. §§ 331(a), 333(a)(2), and 352(f) (2006). see united states’ sentencing memorandum, supra note 4, at 1. 2011] federal government expands its use of the false claims act 421 the company’s intention was to mislead and coerce physicians into prescribing bextra for off-label uses.160 as a result, pfizer was punished for this behavior under the fdca. the $1.195 billion dollar penalty was the largest criminal penalty ever imposed in the united states.161 however, pfizer’s punishment for its off-label marketing behavior went even further. pfizer also settled fca liability with regard to bextra.162 however, beyond the fca’s qui tam feature that enabled pfizer employees to bring pfizer’s off-label marketing behavior to the federal government’s attention, pfizer’s specific violation of the fca is still unclear. and because pfizer did not make an admission during the settlement with regard to any fca liability for the promotion of bextra or the other three pharmaceutical products that it was charged with violating under the fca, there is not much detail with regard to pfizer’s specific improper actions.163 however, we do know that pfizer caused claims to be submitted to federal reimbursement programs through physicians for off-label uses of its drugs.164 and despite a lack of knowledge with regard to the specifics of the doj’s fca allegations against pfizer, it is evident that the threat of exclusion from government-backed health care programs was a factor in pfizer’s willingness to pay such a high settlement amount related to fca liability. the pfizer settlement also implies that a pharmaceutical company will likely pay out millions, if not billions of dollars, if an off-label marketing scheme can be proven or even alleged by the federal government. it seems that if the government can target off-label marketing by a pharmaceutical manufacturer, then fca liability will follow. in essence, the fca provides a way for federal prosecutors to 1) discover off-label marketing violations that the fda otherwise would not have discovered, and 2) increase the penalty for the off-label marketing scheme in order to recover more money for the federal government. c. doj’s focus on fraud the doj has continued to exhibit its intention to prosecute fraud whenever possible. when announcing recent off-label promotion settlements, although the importance of safety within the pharmaceutical industry is often mentioned, the announcements focus more on the recovery of taxpayer dollars through the fca.165 160. see generally united states’ sentencing memorandum, supra note 4 (demonstrating overall off-label scheme by pfizer to sell its drug, bextra, for fda-unapproved uses). 161. the total criminal penalty was $1.3 billion; pfizer paid $1.195 billion and pharmacia and upjohn paid $105 million. see pfizer press release, supra note 2. 162. id. 163. id. 164. id. 165. id. 422 indiana health law review [vol. 8:2 policing health care fraud and recovering funding for government health care programs are stated priorities of the doj: “the doj . . . recognizes both the urgency in the need to recover those funds and the need to ensure that such fraud does not reoccur.”166 in may 2009, to demonstrate its focus on fraud and the recovery of funds for the federal government, the doj announced the creation of the health care fraud prevention and enforcement action team (“heat”).167 the heat task force is comprised of the doj, the department of health and human services (“hhs”), as well as other state and federal law enforcement agencies.168 heat contributed to the 2009 pfizer settlement.169 additionally, much like the assistance given by qui tam relators to detect fca violations, heat is calling upon the general public for assistance in the detection, prevention, and prosecution of fraud.170 in his speech before the senate judiciary committee, tony west, u.s. assistant attorney general, stated, “we have a duty to the taxpayers. . . . while most medical or pharmaceutical providers are doing the right thing, when medicare or medicaid fraud occurs, it costs the american taxpayers real dollars. . . . it is those wrongdoers who we must stop.”171 traditionally, the concern that would arise when a pharmaceutical manufacturer chose to market its drugs for off-label uses was that the public’s health and safety was put at risk because the marketed drugs had not been put to appropriate safety and efficacy tests. currently, when a pharmaceutical manufacturer decides to engage in off-label marketing, the main concern seems to be that the manufacturers are defrauding government programs that are funded by taxpayer dollars.172 the victims of off-label marketing are no longer users of the pharmaceuticals; rather, the victims are now the american taxpayers. no matter how the doj frames the issue, the victims of off-label marketing are admittedly the american public. nonetheless, because the doj is shifting the off-label marketing issue’s focus to fraud, the doj is using the political climate to push an agenda that expands the scope of the fca. 2. judicial interpretation of the fca the judicial branch of government has contributed the least to the expansion of the fca. in fact, the supreme court of the united states attempted to limit the fca’s application, although this limitation was not 166. west strategies, supra note 149. 167. id. 168. id. 169. id. 170. id. 171. id. 172. see pfizer press release, supra note 2. 2011] federal government expands its use of the false claims act 423 within the off-label context.173 many fca qui tam suits related to off-label promotion are dismissed in the early stages of litigation, especially when the federal government does not intervene or join in the suit.174 for example, many qui tam relators have trouble surviving motions to dismiss because they do not plead their fraud claim with particularity.175 furthermore, no reported fca case related to off-label marketing has ever gone to trial. therefore, fca claims related to off-label marketing violations have still not undergone sufficient judicial review.176 however, despite the procedural difficulties that qui tam relators may face when bringing an fca claim, the judicial system has nonetheless expanded fca liability to the pharmaceutical industry for off-label marketing violations. a single judicial opinion effectively opened the floodgates to the pharmaceutical industry’s potential liability for off-label marketing under the fca.177 through one denial of a motion to dismiss, the district court judge created significant leverage for the executive branch when negotiating settlements for off-label marketing with the pharmaceutical industry.178 a. franklin v. parke-davis the parke-davis case proved to be groundbreaking because it legitimized the use of the fca to pursue pharmaceutical manufacturers for offlabel marketing.179 although justice saris’ opinion was based on a denial of parke-davis’ motion to dismiss a qui tam relator’s suit, the opinion has nevertheless proved to be enormously influential. the qui tam relator in parke-davis, dr. david franklin, brought suit against his former employer, parke-davis, a pharmaceutical manufacturer, for liability under the fca.180 specifically, dr. franklin alleged that parke 173. see allison engine co. v. united states ex rel. sanders, 553 u.s. 662 (2008). 174. see, e.g., united states ex rel. rost v. pfizer, inc., 466 f. supp. 2d 6 (2006); see also united states ex. rel. stephens v. tissue science laboratories, inc., 664 f.supp.2d 1310 (n.d. ga. 2009; see also hopper v. solvay pharmaceuticals, inc. 588 f.3d 1318 (11th cir. 2009). 175. see, e.g. hopper, 588 f.3d 1318; see also, u.s. ex rel. bennett v. medtronic, inc. 747 f.supp.2d 745 (s.d. tex. 2010). 176. see girard, supra note 44. 177. see united states ex. rel. franklin v. parke-davis, 147 f. supp. 2d 39 (d. mass. 2001). 178. id. 179. lansdale, supra note 111, at 189 (discussing that the parke-davis case also “represents the emergence of a new legal theory that allows federal prosecutors to hold pharmaceutical companies liable under the fca for making otherwise truthful statements [about their products] that cause others to submit improper claims against the public fisc.”). although there is a strong debate about whether truthful off-label promotion would be considered the basis for fca liability, this particular debate is not the focus of this note. 180. parke-davis, 147 f. supp. 2d at 51. 424 indiana health law review [vol. 8:2 davis’ off-label promotion of its drug, neurontin, caused the submission of false claims to federal health care programs.181 although parke-davis conceded that an off-label prescription that causes reimbursement by medicaid would be considered a false claim under the fca, the company argued that because the company itself did not submit the false claim for government payment, it could not be held liable under the fca.182 the company asserted that dr. franklin could not establish causation under the fca because physicians and patients constituted intervening causes that broke the chain of legal causation.183 however, the court refused to dismiss dr. franklin’s suit because although the physicians, pharmacists, and patients were intervening forces in the chain of parkedavis’ false claim submission, those actors were foreseeable intervening forces, which do not break causal connections.184 the court stated that “the participation of doctors and pharmacists in the submission of false medicaid claims was not only foreseeable, it was an intended consequence of the alleged scheme of fraud.”185 furthermore, parke-davis’ off-label statements about their drug, neurontin, were found to be material to the government’s decision to reimburse claims for the drug.186 the denial of parke-davis’ motion to dismiss legitimized the theory of fca liability for off-label marketing by pharmaceutical manufacturers. the court established that the causal link between a manufacturer’s offlabel promotion scheme and the eventual submission of a claim for repayment to federal health care programs was foreseeable.187 further, the court acknowledged that false statements about a product’s off-label usage could materially influence the federal government’s decision to reimburse a claim for an off-label use.188 the recognition that these two elements of a fca claim could apply in the context of a manufacturer’s scheme of off-label marketing expanded the scope of the fca and proved to be great news for qui tam relators and the federal government. b. an attempt to limit fca expansion on june 9, 2008, the supreme court of the united states announced its unanimous decision to limit the scope of the fca.189 the case, allison engine v. sanders, while not related to off-label marketing, did involve many of the same fca provisions used to attach off-label liability to phar 181. id. 182. id. 183. id. 184. id. 185. id. 186. id. 187. id. 188. id. 189. allison engine co. v. united states ex rel. sanders, 553 u.s. 662 (2008). 2011] federal government expands its use of the false claims act 425 maceutical manufacturers.190 in allison engine, the supreme court limited application of the fca so as not to “transform the fca into an all-purpose antifraud statute.” however, just eleven short months after the allison engine decision was published, it was superseded by legislation.191 the allison engine case involved a contract to build guided missile destroyers for the united states navy (“navy”).192 the navy contracted with two shipbuilders to build the destroyers, and each destroyer required three generator sets to power the ship.193 the shipbuilders then subcontracted with allison engine company (“allison engine”) to build the generator sets for all of the destroyers, who in turn subcontracted with general tool company (“gtc”), who in turn subcontracted with southern ohio fabricators, inc. (“sofco”).194 the navy made sure to include specifications for each destroyer into each of the subcontractors’ contracts.195 two former employees of gtc brought a fca suit as qui tam relators against allison engine, gtc, and sofco (collectively “subcontractors”) for submitting invoices to the shipbuilders (not the navy) for reimbursement of their work.196 the qui tam relators alleged that the subcontractors had not built the generator sets in accordance with the navy’s contract specifications and, therefore, fraudulently sought payment from the federal government under the fca.197 the supreme court rejected the lower court’s decision that it is enough for a plaintiff to show that a false statement resulted in the government’s payment of a false claim.198 instead, the supreme court held that defendants must have an intent “to get” a false claim paid by the government under the fca’s statutory language.199 the court held that it was not enough that a false claim be paid using government funds; therefore, the court reversed in favor of the subcontractors.200 the court noted that an elimination of the intent requirement would expand the fca “well beyond its intended role of combating ‘fraud against the government.’”201 because the subcontractors intended that the shipbuilders, rather than the federal government, pay them for building the generator sets and because there was 190. id. 191. see discussion of the federal law that superseded the allison engine decision, infra section iii(c). 192. allison engine, 553 u.s. at 665. 193. id. 194. id. 195. id. 196. id. at 666-67. 197. id. 198. id. at 668. 199. id. 200. id. at 673. 201. id. at 669. 426 indiana health law review [vol. 8:2 no proof that the subcontractors had the intent to defraud the government itself, the subcontractors were not liable under the fca.202 this unanimous decision by the supreme court seemed to suggest the court’s desire to limit the scope of the fca. the subcontractors in allison engine arguably had a much closer link to a government payout than any pharmaceutical manufacturer may have to government reimbursement of an off-label prescription. nevertheless, the supreme court felt that the link was too attenuated and declined to attach fca liability to the subcontractors.203 the supreme court reasoned that when a defendant makes a false statement to a private entity for reimbursement without the intention that the government rely on that false statement as a condition of payment, then the “direct link between the false statement and the government’s decision to pay or approve a false claim is too attenuated to establish [fca] liability.”204 it is quite possible that a pharmaceutical company could apply the supreme court’s analysis in allison engine to defeat fca claims based on off-label marketing by asserting a “direct link” defense to government payout or claim a lack of intent to influence payment by the federal government. what is interesting about the allison engine decision is that the dispute in question involved a more traditional application of the fca. as mentioned earlier, the fca was enacted during the civil war in order to prevent profiteers from hindering the war effort with “rampant fraud and shoddy supplies.”205 the allison engine case involved navy shipbuilders that claimed reimbursement for work that did not adhere to the navy’s specifications.206 therefore, even when applying the language of the fca to a more traditional fact pattern, the supreme court limited liability.207 because fca liability tied to off-label marketing schemes is based on less traditional legal arguments than the arguments made in allison engine, it is not too far-fetched to predict that our supreme court may also limit liability in the off-label context based on the language of the fca. after the announcement of the allison engine decision, it was not long before many defendants used the case to assert defenses against fca claims by qui tam relators.208 although allison engine demonstrates that courts are willing to limit the scope of fca liability, the parke-davis opinion still holds to expand liability for off-label marketing under the fca. in fact, in a recent case brought by a qui tam relator against a pharmaceutical 202. id. at 672-73. 203. id. at 672. 204. id. 205. lansdale, supra note 111, at 168. 206. allison engine, 553 u.s. at 665. 207. see id. 208. united states ex rel. kennedy v. aventis pharmaceuticals, inc., 610 f. supp. 2d 938 (n.d. ill. 2009). 2011] federal government expands its use of the false claims act 427 manufacturer involving allegations of off-label liability under the fca, the pharmaceutical manufacturer cited the allison engine decision in its motion to dismiss the relator’s claims.209 the defendant pharmaceutical manufacturer emphasized, by quoting the allison engine opinion, that under the fca, “a defendant is answerable for ‘the natural, ordinary and reasonable consequences of his conduct, though not for anything beyond that.”210 however, the district court rejected the manufacturer’s use of allison engine as a defense in favor of the reasoning in parke-davis.211 the district court applied the parke-davis foreseeability approach instead of the direct link approach to causation.212 therefore, at least in terms of the causation element under the fca as applied to off-label marketing, a court was willing to allow the claim to survive a motion to dismiss and the parke-davis foreseeability approach to causation was favored over the direct link approach in the off-label context.213 this case demonstrates how influential the parke-davis reasoning is when applying the fca to off-label marketing by pharmaceutical manufacturers.214 despite the supreme court’s attempt to limit fca liability in the allison engine case, the fca has still been interpreted quite liberally in the offlabel marketing context.215 thus, although many fca qui tam claims get dismissed in the early stages of litigation, the parke davis reasoning still serves as an expansion to off-label liability under the fca. 3. legislative expansion of the fca in addition to executive and judicial expansion of the fca, the legislative branch has also contributed to the recent expansion of the fca. in a swift response to the allison engine decision, congress passed the fraud enforcement and recovery act of 2009, the most significant amendment to the fca since 1986.216 a. fraud enforcement and recovery act amends the fca the fraud enforcement and recovery act of 2009 (“fera”) was enacted on may 20, 2009.217 the stated purpose of the legislation was to “reinvigorate our nation’s capacity to investigate and prosecute the kinds of 209. id. 210. id. (quoting allison engine, 553 u.s. at 665). 211. kennedy, 610 f. supp. 2d at 944. 212. id. 213. id. 214. id. 215. see, e.g., id. at 938. 216. the fraud enforcement and recovery act of 2009, pub. l. no. 111-21, 123 stat. 1617 (2009). 217. id. 428 indiana health law review [vol. 8:2 financial frauds that have so severely undermined our financial markets and hurt so many hard working people in these difficult economic times.”218 while the legislation was not specifically related to health care or off-label marketing, fera actually widened the scope of the fca. therefore, it will likely affect the pharmaceutical industry in the off-label context. one senate judiciary committee report outlining the purpose of fera addressed the reasoning for fera’s amendments to the fca. the report stated, “[t]he effectiveness of the fca has recently been undermined by court decisions limiting the scope of the law. . . . [t]he fca must be corrected and clarified in order to protect [from fraud] the federal assistance and relief funds expended in response to our current economic crisis.”219 specifically, in the senate report, congress was referring to the allison engine decision’s interpretation of the fca’s scope.220 in enacting fera, congress eliminated the requirement of intent announced in allison engine.221 now there is no requirement for a qui tam relator or the federal government to establish a direct link between a false statement and the eventual government payment of the claim.222 as amended, the fca now only requires that an entity or an individual knowingly or recklessly attempt to defraud the government.223 therefore, while the allison engine court tried to avoid transforming the fca into an “all-purpose antifraud statute,” congress effectively overturned the court’s decision by expanding the fca into just that.224 as a result of fera, potential fca liability may attach to any company or individual that conducts business in the health care industry.225 b. political climate ripe for increased legislation fera was passed at a time when the united states’ economy was quite vulnerable. fera was primarily a response to the bank and mortgage lending crises. congress’ opinion was that the united states was in “the most serious economic crisis since the great depression.”226 in a struggle to pull the economy out of imminent downturn, congress took action by placing the blame for the state of the union on fraud by big businesses and 218. s. rep. no. 111-10, at 3 (2009). 219. s. rep. no. 111-10, at 10. 220. s. rep. no. 111-10, at 10-11. 221. see allison engine co, v. u.s. ex re.l sanders, 553 u.s. 662 (2008). 222. rhoad et al., supra note 125, at 17. 223. letter from m. faith burton, acting assistant att’y gen., u.s. dep’t of justice, to patrick j. leahy, chairman, comm. on the judiciary, u.s. senate (april 1, 2009), available at http://www.justice.gov/ola/views-letters/111-1/040109-s386-fraud-enforcement-recoveryact.pdf. 224. allison engine, 553 u.s. at 672. 225. rhoad et al., supra note 125, at 16. 226. s. rep. no. 111-10, at 2. 2011] federal government expands its use of the false claims act 429 sought to make available any tool at the federal government’s disposal to deter and punish those businesses. the senate judiciary committee report on the background of fera demonstrates this point: to make sure this kind of collapse cannot happen again, we must invigorate our anti-fraud measures and give law enforcement agencies the tools and resources they need to root out fraud so that it can never again place our financial system at risk. taxpayers, who bear the burden of this financial downturn, deserve to know that the government is doing all that it can to hold responsible those who committed fraud in the run-up to this collapse.227 as a result, the powerful enforcement tool that has been used to reach off-label marketing was strengthened. therefore, when enacting fera’s amendments to the fca, congress did not fail to mention how important the legislation was to fixing our nation’s broken economy in the wake of the banking crisis.228 congress did not hesitate to take advantage of the current political climate when expanding the scope of a major tool that the federal government uses to extract funding from companies that defraud the federal government. imbedded in fera, an economic recovery bill, were amendments to a federal law that has the ability to do significant damage to any business that is directly or indirectly paid with government funds.229 an enforcement tool that is capable of such severe damage seems worthy of more legislative consideration. however, because the fca is such an effective tool at recovering money for the federal government, congress did not hesitate to expand its scope. b. the effect of continued fca expansion on the pharmaceutical industry the days of commonplace off-label promotion in the culture of the pharmaceutical industry seem to be coming to a close. when taking the actions of all three branches of the federal government as a whole, it is conceivable that pharmaceutical manufacturers’ potential liability under the fca will only continue to increase. although the above three sections addressed each branch of government’s contribution to the expansion of the fca separately, it is important to take a look at the cumulative effect of the federal government’s expansion of the fca on the pharmaceutical industry. 227. s. rep. no. 111-10, at 3. 228. s. rep. no. 111-10, at 8. 229. see generally the fraud enforcement and recovery act of 2009, pub. l. no. 11121, 123 stat. 1617 (2009). 430 indiana health law review [vol. 8:2 first, it is unlikely that fera’s amendments to the fca will have a very noticeable effect on off-label litigation, at least in the courts.230 the reason that post-fera fca cases will “feel” the same as pre-fera cases, at least when the doj intervenes in the litigation, is because most off-label fca cases do not make it to trial due to the threat of exclusion and treble damages.231 because most off-label cases settle, it will be difficult to measure the actual affect that fera’s amendments will have on off-label litigation.232 in the case of qui tam suits where the government declines to intervene, qui tam litigants may have stronger cases against pharmaceutical manufacturers due to the expanded scope of the fca’s language. however, just because it will be difficult to actually see the effects of fera in the off-label context, does not mean that fera will not affect the pharmaceutical industry. fera’s expansion of the fca will give federal prosecutors more leverage when negotiating settlements with pharmaceutical companies for off-label marketing violations. now, instead of relying on the parke-davis precedent, federal prosecutors will have more backing under the law through the new, expansive statutory language.233 but, as discussed previously, the doj already possesses a great deal of leverage against pharmaceutical manufacturers. the only hope the pharmaceutical industry may have for limiting liability under the fca for off-label marketing is if a pharmaceutical manufacturer decides to take the risk of litigation against a qui tam relator. the judicial branch seems the most willing to rein in the doj’s and congress’ use of the fca. furthermore, the parke-davis decision only involved a motion to dismiss in a district court.234 other federal or district courts may interpret an off-label case differently or use a different standard of review than that employed in a motion to dismiss. however, many pharmaceutical manufacturers were not willing to take a chance on litigation before fera. because fera expanded the fca’s scope, it is even more unlikely that a pharmaceutical manufacturer would take the risk to litigate. furthermore, the court would likely interpret an off-label case similarly to the parkedavis decision. the doj has recently been given the political green light by congress to pursue fraud whenever possible.235 the powerful anti-fraud tool that the 230. drew harker & mahnu davar, arnold & porter llp, presentation, the 2009 false claims act amendments and implications for the pharmaceutical and medical device industry (oct. 23, 2009), available at http://www.arnoldporter.com/resources/documents /cbi%20fera_fca%20off-label%20slides%20--%20harker%20and%20.pdf. 231. id. 232. id. 233. see generally the fraud enforcement and recovery act of 2009, pub. l. no. 11121, 123 stat. 1617 (2009). 234. united states ex. rel. franklin v. parke-davis, 147 f. supp. 2d 39, 43-44 (d. mass 2001). 235. see s. rep. no. 111-10, at 3. 2011] federal government expands its use of the false claims act 431 doj possessed and used against pharmaceutical manufacturers in the past for off-label marketing enforcement became even more powerful through fera.236 because the doj has demonstrated an increased pursuit of the pharmaceutical industry throughout the past decade, it is unlikely that this trend will stop, especially with additional support from congress.237 it is likely not coincidental that the landmark pfizer settlement occurred only three months after the fera amendments were passed and the heat task force was created.238 some critics argue that the massive settlement amounts will not stop the pharmaceutical industry from continuing to promote their pharmaceutical products for off-label uses.239 because the pharmaceutical industry is a multi-billion dollar industry, many companies have the ability to include potential settlement amounts into their business plans.240 for example, when pfizer settled with the doj for $2.3 billion, the billion-dollar figure was accounted for in pfizer’s fourth quarter earnings.241 however, this settlement amount decreased pfizer’s quarterly profit by ninety percent.242 furthermore, the settlement amounts have only increased over the years.243 if settlements continue on the path of costing pharmaceutical companies billions of dollars, off-label promotion may not continue to be commonplace in the industry. it is clear at this point that liability for off-label marketing under the fca is not going to disappear any time soon. the goal of recovering taxpayer dollars in the wake of a troubled economy may be noble; however, the federal government’s focus on this goal is clouding its judgment when deciding the proper tool to use when regulating off-label marketing. c. the federal government needs to refocus its off-label enforcement efforts the federal government needs to reassess its aggressive enforcement of the pharmaceutical industry with regard to off-label marketing under the fca. fdca law already provides for actions by pharmaceutical manufacturers to promote their products for off-label uses. when the doj pursues a pharmaceutical manufacturer for off-label marketing violations, the bases for those pursuits are the manufacturer’s violation of the fdca. as the 236. rhoad et al., supra note 125, at 14. 237. see generally id. 238. see generally pfizer press release, supra note 2; see also the fraud enforcement and recovery act of 2009, pub. l. no. 111-21,123 stat. 1617 (2009). 239. tom murphy, fines unlikely to halt off-label drug promos, indianapolis star (sept. 5, 2009), available at http://www.mdjonline.com/printer_friendly/3531953. 240. id. 241. id. 242. id. 243. see, e.g., top 20 cases, supra note 13. 432 indiana health law review [vol. 8:2 federal government began focusing on fraud by the pharmaceutical industry under the fca, it lost sight of the policy goals underlying the fdca. the fda, through the fdca, has traditionally regulated off-label marketing by the pharmaceutical industry.244 the fdca provides that the fda may call upon the doj to enforce violations of its provisions, if the fda chooses to do so.245 this regulatory framework should remain intact. scholars contend that, “[v]iolations of a specific statutory structure such as the fdca should be handled by that statutory system.”246 the fda, not qui tam relators or the doj, is “specifically charged with implementing the public health goals of the [fdca].”247 although the doj, particularly through the fca’s qui tam provisions, has uncovered massive off-label violations, the “advantages associated with focusing on correction and compliance should not be cast aside without careful consideration of the impact on the [fdca’s] primary goal of promoting and protecting the public health.”248 there is a clear disconnect between the fda’s pursuit of pharmaceutical manufacturers for off-label marketing and the doj’s pursuit of pharmaceutical manufacturers for off-label marketing. the fda has recently expanded the pharmaceutical industry’s ability to promote its products for off-label uses.249 meanwhile, other branches of our federal government are expanding potential liability for the off-label promotion of pharmaceutical products under the fca. because the legal and medical communities alike hotly contest the benefits and risks of off-label use, it makes much more sense to leave the debate within the control of the experts employed at the fda.250 the fda is in the best position to balance the benefits and risks of off-label use and marketing and can issue guidance with regard to proper marketing practices. furthermore, the fda can affect the pharmaceutical manufacturers’ off-label marketing behavior through already provided-for punishment mechanisms within the fdca.251 however, in order for the fda to take back complete control of offlabel marketing investigation and regulation, the fda must fix its regulatory gaps. the fda has been criticized for its inability to detect off-label marketing violations by the pharmaceutical industry.252 therefore, the fda needs to increase its off-label marketing investigations. for example, the fda can consider increasing oversight of off-label promotional activities in contexts in which pharmaceutical companies usually promote to physi 244. hall & berlin, supra note 125, at 56-57. 245. see generally 21 u.s.c. §§ 301-399. 246. hall & berlin, supra note 125, at 674. 247. girard, supra note 44, at 143. 248. id. at 148-49. 249. see generally good reprint practices, supra note 11. 250. see generally girard, supra note 44. 251. see generally 21 u.s.c. §§ 301-399 (2009). 252. see generally u.s. gov’t accountability office, supra note 84. 2011] federal government expands its use of the false claims act 433 cians—in continuing medical education seminars and in hospitals. the fda can also conduct better oversight of promotional materials that lack strong scientific support.253 it may even be possible for the fda to begin a campaign to provide financial incentives to physicians and others who report off-label promotion by pharmaceutical companies.254 this system could mimic the role of fca qui tam relators. one benefit of fca qui tam litigation, as mentioned previously, is that it has unveiled various off-label marketing techniques employed by pharmaceutical manufacturers.255 the fda has previously been unable to detect these types of marketing techniques because they are done behind closed doors. however, now that qui tam litigators have revealed these various techniques, the fda can devote its resources to detecting these violations. iv. conclusion the fca’s main purpose is to prevent fraud perpetrated upon the federal government. despite the fact that the fca does not provide any specific penalty for off-label promotion, the federal government has successfully connected the pharmaceutical industry’s off-label marketing schemes to a purported intention to defraud the federal government. at first blush, this connection seems to make some sense. after all, the pharmaceutical industry depends upon federal health care reimbursement programs for a large percentage of its profits. therefore, when a pharmaceutical manufacturer engages in illegal off-label promotion, this promotion will eventually cause a claim to be submitted to a government health care reimbursement program for an off-label use. thus, when the federal government reimburses the pharmaceutical manufacturer based on an initial illegal action, the manufacturer is effectively defrauding the federal government. the doj justifies its rampant pursuit of pharmaceutical manufacturers based on this train of thought. through this justification, the federal government has effectively recharacterized traditional public policy considerations under the fdca, while pursuing fca liability for off-label marketing. no one can deny the public’s interest in punishing pharmaceutical companies for deliberately putting the public’s health at risk in order to turn greater profits. however, it is important that the federal government uses the correct enforcement tools to punish off-label marketing behavior. because fca liability for off-label marketing always starts with a violation of the fdca, the fdca, and not the fca, is the proper federal law to enforce 253. stafford, supra note 79, at 1429. 254. adriane fugh-berman & douglas meinick, off-label promotion, on-target sales, 5 plos med. 1432,34 (2008). 255. see united states’ sentencing memorandum, supra note 4. 434 indiana health law review [vol. 8:2 off-label marketing violations. the recent expansion of the fca encourages pharmaceutical manufacturers to settle cases when faced with liability for off-label marketing under the fdca. the theories of fca liability in the off-label context are deserving of judicial review before these coercive settlements continue. in conclusion, the fda is best suited for regulating the pharmaceutical industry. the fda is able to balance the risks and benefits surrounding off-label use and promotion and can also use enforcement tools already provided-for under the fdca to ensure the pharmaceutical industry’s compliance with the law. indiana iieaith law review volume7 2010 articles the "shared accountability" approach to physician payment: four options for developing accountable care organizations competition policy in health care in an era of reform notes how old is too old?: the need for federal regulation imposing a maximum age limit on women seeking infertility treatments combating obesity: our country's need for a national standard to replace the growing patchwork of local menu labeling laws negligence, medical malpractice; vicarious liability, or patient responsibility: who should pay when a patient contracts mrsa from a healthcare facility? follow-on biologics legislation: striking a balance between innovation and affordability preemptive legislation in the european union and the united states on the topic ofnanomedicine: examining the questions raised by smart medical technology issue 2 jackson williams max huffman melissa reynolds ashley arthur beth a. barnes brian r. bouggy emilee s. preble indiana university school of law indianapolis iupui indiana health law review volume7 exec11tive mttllllging editor rachel k. hebner executive production editors susan kindig, m.d. shena wheeler execlltlve biisiness editor stephen donham note deve/dpment editors lauren hulls hilari a. sautbine adam bolerjack matt lasher roxanna bell j.c.brown jennifer cooper bobby a courtney, m.a. matthew derringer allison neil deyoung kelly earls elizabeth eichholtz amy halsey paul jansen editor-in-chief brian r. bouggy articln editors trampas whalin chris arrington anna ly-pham ashley arthur executive notes editor marc a menkveld executive articles editor mary beth arnold 2010 executive syiltposi11111 editor contessa m. wilson, pharm. d. melissa reynolds marc steams barbara molargik·fitch beth ann barnes kristin mccreary elliot mckinnis lucasmlsna dennis mullen vijaypatel melissa stuart, m.s. andrea white zach williams chad wilson, d.p.t katie wood. fiiciilty advisors lawrence p. wilkins (chair) eleanor d. 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program and public interest. b.a., murray state university; m.a., illinois state university; m.s., old dominion university; j.q., indiana university school of law-indianapolis. tamaramcmiluan,associatedirectorofprofessiona/ development. b.a., southern illinois university-carbondale; m.s.w., southern illinois state university-carbondaje; j.d., depaul university college oflaw susm agnew, assistant director of student services. clark college. william j. baker, assistant director of technology services. karen h. miller, assistant director for admissions. midway college. lisa schrage, assistant director for donor relations. b.s., marian college. faculty cynthia m. adams, clinical professor of law and co-director of the latin american law program. b.a., kentucky wesleyan college; j.d., indiana university school of law-indianapolis. judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school oflaw. cynthia baker, clinical associate professoroflawanddirector, program on law and state government. b.a., j.d., valparaiso university. gerald l. bepko,lndiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. shawn boyne, associate professor of law and dean's fellow. b.a., cornell university; m.b.a., university of minnesota, j.d., university of southern california's gould school of law, m.a., university of wisconsin, l.l.m., justus-liebig~universtat. karen e. bravo, associate professor law; johns. grimes fellow and dean's fellow. b.a., the university of the west indies; j.d., columbia university school oflaw; ll.m., new york university school of law. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. chestek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university ofpittsburgh school of law. daniel h. cole, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school. jeffrey 0. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. eruc dannenmaier, associate professor of law and dean's fell ow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university. james d. dimitri, clinical professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer a. drobac, professor of law and director, central and eastern european law summer program. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. george e. eow ards, carl m gray professor of law; faculty advisor to the ll.m track in international human rights law; director, program in international human rights law and john s. grimes fellow. b.a., north carolina state university; j.d., harvard law school. frank emmert, john s. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university ofmunich law school; ll.m., the university ofmichigan law school; ph.d., university of maastricht; diploma, european university institute. nicholasgeorgakopoulos, harold r. woodard professor of law. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. carrle hagan-ora y, clinical associate professor of law. b.a., university of kansas; j.d., university of cincinnati, college of law. john la wrencehill, professor of law,' adjunct professor of philosophy and johns. grimes fellow. b.a., northern illinois university; j.d., ph.d., georgetown university. linda kelly hill, m dale palmer professor of law. b.a., j.d., university of virginia. max huffman, associate professor of law and dean's fellow. b.a., cornell university, j.d., university of chicago college of law. lawrence a. jegen, iii, thomas f. sheehan professor of tax law and policy. a.b., beloit college; j.d., m.b.a., the university of michigan; ll.m., new york university school of law. robert a .. katz, professor of law and johns. grimes fellow. a.b., harvard college; j.d., university of chicago law school. eleanor d. kinney, hall render professor of law, co-director of the william s. and christine s. hall center for law and health. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. andrew r. klein, paul e. beam professor of law. b.a., university of wisconsin; j.d., emory university school of law. normanlefstein, professor of law and dean emeritus. ll.b., university oflllinois college of law; ll.m., georgetown university law school. maria p ab6nl6pez, professor of law and dean's fellow. b.a., princeton university; j.d., university of pennsylvania law school. gerard n. magliocca, professor of law; co-director, chinese law summer program and johns. grimes fellow. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor of law. b.s., j.d., university of illinois. deborah mcgregor, clinical professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. mary h. mitchell, alan h. cohen professor of law. a.b., butler university; j.d,; cornell law school. emilymorris,associateprofessoroflawanddean 'sfellow. a.b., harvard university, j.d:, university of michigan law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. david orentucher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, associate professoroflaw and dean's fel/qw. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kathleen patchel, associate professor of law. a.b., huntington college; j.d., university ofnorth carolina law school; ll.m., yale law school. michael j. pitts, associate professor of law; dean's fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. peter a. prescott, associate professor of law. b.a., augustana college; m.s., the university ~f chicago; m.p.a., the university of texas at austin; j.d., the university of houston law center. fran quigley, visiting professor. b.a., hanover college; m.a., indiana university; j.d., indiana university school of law-indianapolis. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. gary r. roberts, dean and gerald l. beplw professor of law. b.a., bradley university; j.d., stanford university. joan m. ruiitenberg, professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university school of law-indianapolis. joel m. schumm, clinical professor of law and director, judicial extemship program. b.a., ohio wesleyan university; m.a., university of cincinnati; jd., indiana university school of law-indianapolis. frances watson, clinical professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. lloyd t. wilson, jr., professor of law and co-director, chinese law summer program. b.a., wabash college; m.a., duke university; j.d., indiana university school of law-bloomington. maryt. wolf, clinical professoroflaw anddirectorofclinical programs andexternships. b.a., saint xavier college; j.d., university oflowa college of law. r. george wright, lawrence a. jegen ill professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law-indianapolis. emeriti faeulty thomas b. aujngton, professor of law emeritus. b.s., j.d., university ofnebraska; ll.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, iii, professor of law emeritus and director of the law library emeritus. a.b., j.d., m.a.l.s., the university ofmichigan. clyde harrison crockett, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. f alender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school of law-indianapolis. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.sj., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey.·w, grove, professor of law emeritus, a.b., juniata college; j.d., george washington university law school. · · wiwam f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university ' ofmissouri; j.d., ll.m., georgetown university law school. w. wiluam hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. henry c. karlson, professor of law emeritus. a.b., j.d., ll.m., university of lllinois . college of law. williaj4 andrew kerr, professor of law emeritus. a.b., west university; b.s., duke university; j.d., ll.m., harvard law school. wiluam e. marsh, professor of law emeritus. b.s., j.d., university ofnebraska. ronald w. polston, professor of law emeritus. b.s., eastern lllinois university; ll.b., university of illinois college of law. 'kbnnetii m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james w. torke, carl m gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. ab., university oflowa; j.d., ll.m., george washington university law school. lawrence p. wilkins, william r. neale professor of law emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., university oftexas school of law. law library faeulty judrmpordanspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent st~ite university; j.d., mississippi college school of law. susan boland, head of information services. b.a, monmouth college; m.s., university of illinois; j.d., illinois university college of law. debra denslaw, reference librarian. b.a., franklin college; m.s., university of illinois, urbana~champaign; j.d., valparaiso school oflaw. richard humphrey, reference librarian. a.a., brewton~parlcer junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, assistant director for technical services. ab., taylor university; m.l.s., indiana university. chris e. long, cataloging librarian. b.a, indiana university; m.a., indiana university; m.l.s., indiana university. stevenr. miller, reference librarian. b.s., lebanon valley college ofpennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k.. moshfegh, serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a, ball state university; m.l.s., ph.d., indiana univ~ity. miriam a muju'hy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyoshiotsu,automated services and media librarian. a.a., parkland college; ab., m.s., c.a.s., university oflllinois. indiana health law review volume7 table of contents articles the "shared accountability" approach to physician payment: four options for developing issue2 accountable care organizations ...... ; ................................... jackson williams 185 competition policy in health care in an era of reform .................................................................... max huffinan , 225 notes how old is too old?: the need for federal regulation imposing a maximum age limit on women seeking infertility treatments ........................................ ~ .................................... meliss,a reynolds 277 combating obesity: our country's need for a national standard to replace the growing patchwork of local menu labeling laws .................................. ashley arthur 305 negligence, medical malpractice, vicarious liability, or patient responsibility: who should pay when a patient contracts mrsa from a healthcare facility? ................................................................ beth a. barnes 335 follow-on biologics legislation: striking a balance between innovation and ajjordability ..................... brian r. bouggy 367 preemptive legislation in the european union and the united states on the topic ofnanomedicine: examining the questions raised by smart medical technology ............ ~ ...... emilee s. preble 397 2010 anti-depressants and children: suicidality, off-label use, and trial publication timothy j. hixson· introduction antidepressants, specifically selective serotonin reuptake inhibitors (ssris ), have been used to treat a plethora of neurological diseases, such as major depressive disorder (mdd)and obsessive compulsive disorder (ocd). 1 the first ssri medication available for prescription was eli lilly company's prozac, which received food and drug administration (fda) approval in 1987.2 initially, ssris were attractive to physicians because they appeared to have few side-effects and be more effective than previous medications.3 however, in 1990, questions arose as to whether ssris caused patients to commit suicide. 4 although there is some anecdotal evidence to support the theory that ssris cause suicide, there is little scientific evidence to support the claim, and the fda has previously resisted placing "black box" labels (the strongest available) on ssri medications. 5 as ssris became more prevalent, doctors began prescribing them to adolescent and pediatric patients, although the drugs were not approved for such uses. 6 these prescriptions, known as off-label prescriptions, have increased despite a lack of efficacy data and pediatric drug trials. 7 steps such as collecting efficacy data and performing drug trials are important because a drug safe for use in adults may not be safe for children due to metabolic and * j.d. candidate, 2006, indiana university school of law-indianapolis; ba, 2003, butler university, indianapolis, indiana. 1. food & drug admin., public health advisory, worsening depression and suicidality in patients being treated with antidepressant medications (mar. 22, 2004), http://www.fda.gov/cder/drug/antidepressants/antidepressanstpha.htm (last visited feb. 27, 2006). 2. andrew e. falsetti, fluoxetine-induced suicidal ideation: an examination of the medical literature, case law, and the legal liability of drug manufacturers, 51 food & drug l.j. 273,274 (2002). 3. see symposium, supporting materials: a sta.ffcompilation of relevant statutory, statistical, and case materials, 8 u.c. davisj. juv. l. &pol'y 315,334 (2004) [hereinafter symposium]. 4. falsetti, supra note 2, at 275. 5. see generally id. 6. see food & drug admin., fda proposed medication guide: about using antidepressants in children or teenagers (oct. 21, 2004), http://www.fda.gov/cder/drugl antidepressants/ssrimedicationguide.htm (last visited nov. 21, 2004). 7. chris adams & alison young, off-label prescriptions slipping by fda, tallahassee democrat, nov. 4, 2003, http://www.tallahassee.com/mld/democrat/7175710 .htm?template=contentmodules/prints ... (last visited october 14, 2004). 202 indiana health law review [vol. 3:201 physiological differences between children and adults. 8 recent events have called into question the safety and efficacy ofssris when used in adolescents and children.9 as a result, the fda convened a group of experts to scrutinize data available from previous drug studies to determine whether a stronger warning should be placed on ssri labels. 10 the fda • s study resulted in the agency acknowledging that ssris could cause some children and teenagers to become suicidal,'' and raised questions concerning: manufacturer versus prescriber liability, pediatric drug testing and research, and publication of clinical/drug trial results. these questions are important for the legal and medical communities to consider not only because of the potential harm that may be caused by these drugs, but also their potential benefits. i. suicide link a. depression and suicide part of the difficulty in determining whether ssris are causally linked to suicide is the nature of depression itself. depression is widespread in the united states and suicidal ideation occurs in as many as ninety percent of all depressed patients. 12 furthermore, approximately fifteen percent of those suffering from depression will take their own lives. 13 overall, "suicide is the eighth leading cause of death in the united states and accounts for 1.5% of all annual deaths."14 as a result, it is often difficult to determine whether a suicide or suicidal ideation is caused by the ssri medication rather than the underlying illness. 8. gregory hazard, please, sir, i want some more: congress' carrot-and-stick approach to pediatric testing leaves therapeutic orphans needing more protection, 20 j. contemp. heal till. & pol'y 467,478-79 n. 64 (2004). 9. see mary ann liebert, clinical trials, 23 biotechnology l. rep. 567 (2004) (discussing glaxosmithkline withholding findings that its ssri, paxil, was no more effective than a placebo and may increase the risk of suicide). l 0. food & drug admin., talk paper, fda updates its review of antidepressant drugs inchi/dren(aug.20,2004),http://www.fda.gov/bbs/topics/answers/2004/ans01306.html (last visited apr. 19, 2006). 11. tell truth about antidepressants on drug labels and in medical journals, newsday, sept. 15, 2004, at a42. 12. falsetti, supra note 2, at 273. 13.id. 14.id. 2006] anti-depressants and clm.dren 203 b. adults 1. theories of suicidality at their introduction, ssris were widely regarded as an important medical discovery. 15 physicians readily accepted ssris and began prescribing them to patients due to favorable clinical trial data, which indicated that ssris were more effective and "had far fewer dangerous side effects than other classes of antidepressants."16 despite the acceptance of the medical community and favorable drug trial data, shortly after the introduction of ssris, ''reports describing ssri-induced violence against self and others began to appear ... 17 the ftrst of these reports was produced by dr. martin teicher and colleagues, which spurred further reports with theories alleging that ssris are linked to suicidality.18 there are three basic "direct causation" theories of ssri-induced suicidality, and a fourth theory in which ssris are thought to have an indirect causal relationship.19 the basic theories are: 1) the ·initiative theory; 2) the efficacy theory; and 3) the "rollback phenomena.''20 under initiative theory, it is thought that depressed patients will "regain initiative and energy before an improvement in cognition and mood occurs, and this could mobilize an individual to carry out suicidal thoughts.''21 efficacy theory suggests that in situations where the medication is ineffective, the patient may commit suicide either due to the natural progression of the disease or discouragement resulting from treatment failure.22 the theory of"rollback phenomena" suggests that ssris will work to relieve depression "in the reverse order in which it manifested itself; thus, if the patient previously had experienced a period of suicidal ideation, it may reappear with continued treatment.''23 the fourth theory of suicidality suggests that the suicidal ideation is truly in response to a severe form of psychomotor agitation known as akathisia.24 akathisia is an inner sense of restlessness and an inability to sit still, which patients often describe as feeling like they are "jumping out of their skin."25 this theory suggests a link between akathisia and suicidal 15. symposium, supra note 3, at 334. 16. /d. 17. /d. 18. falsetti, supra note 2, at 275. 19. /d. at 274-76. 20. id. 21. id at 274. 22. /d. 23. falsetti, supra note 2, at 274. 24. /d. see alyo miller v. pfizer, inc., 196 f. supp. 2d 1095, 1109 (d. kan. 2002). 25. falsetti, supra note 2, at 274-75. 204 indiana health law review [vol. 3:201 ideation. 26 it is suggested that under this theory suicidal ideation is an extreme response to the unpleasant sensation produced by akathisia and ''not true suicidal ideation as is typically described by depressed patients experiencing suicidal ideation. "27 2. scientific link regardless of the theories of how ssris may cause suicide, the underlying question is whether there is a true scientific causal relationship between ssris and suicide. the fda, drug manufacturers, and other agencies have studied this possible link since just after the first anecdotal reports were published in 1990.28 in 1991, 1992, 1997, and 2002, the fda conducted periodic safety reviews on this issue, and "each time fl ound] no scientific basis for a warning that ssris cause suicide. "29 often the nature of depression itself makes it difficult to ascertain one distinct cause for a patient's suicide. the fda has recognized that "although antidepressants in general may have the ability to cause suicidal ideation, its occurrence is too rare to be affirmatively attributed to the drugs, and that depression itself is a cause ofsuicide."30 despite the lack of scientific evidence to support a claim that ssris cause suicide, the anecdotal evidence has been enough to persuade people who could benefit from the drugs not to use them.31 when considering the question of whether ssris cause suicide it is important to consider the benefits these drugs could have in a patient's life. as the court noted in the recent case of miller v. pfizer, inc.: [w]hatever the explanation, studies of suicide rates among fluoxetine users have not indicated an increased risk of suicide attempts or completions, relative to users of other antidepressants; in fact, [the most recent textbook by the american psychiatric association] notes that larger controlled studies have confirmed that suicide rates among depressed patients treated with fluoxetine (and all other · antidepressants) are markedly reduced from those of depressed patients who do not receive antidepressants. 32 26. see miller v. pfizer, inc., 196 f. supp. 2d 1095, 1109 (d. kan. 2002); cloud v. pfizer, inc., 198 f. supp. 2d 1118, 1123 (d. ariz. 2001). 27. cloud, 198 f. supp. 2dat 1123 (d. ariz. 2001). 28. see needleman v. pfizer, inc., 2004 wl 1773697, at *2 (n.d. tex. 2004). 29. id. 30. falsetti, supra note 2, at 279. 31. /d. 32. miller, 196 f. supp. 2d at 1109 (d. kan. 2002)(citing american psyc. assoc., textbook of psycidatry (3d. edition 1999)). 2006] anti-depressants and children 205 additionally, the american college of neuropsychophannacology (acn) notes several shortcomings common to the case reports suggesting a link between ssris and suicidal ideation. 33 reports suggesting a link between ssris and suicidal ideation failed to distinguish between the potential contribution of the disease process, external stressors, and the medication. 34 also, such suicidal ideation is not specific to any one type of antidepressant, which suggests that the suicidal ideation may be a manifestation of the disease itself.35 in light of this evidence, and the shortcomings of the reports suggesting a link between ssris and suicidality, the american college ofneuropsycho­ phannacology issued a consensus statement that concluded: there is no evidence that antidepressants such as the selective serotonin reuptake inhibitors [ssris ], for example, fluoxetine [prozac], trigger emergent suicidal ideation over and above rates that may be associated with depression and other antidepressants. what is clear is that most patients receive substantial benefit from treatment with this drug and related antidepressants. 36 an acn task force review further concluded that "new generation low­ toxicity antidepressants, including ssris, may carry a lower risk for suicide than older tcas [tricyclic antidepressants].'m nearly all scientific reviews of the issue agree that although suicidal ideation may enierge during treatment with antidepressants, a causal relationship between suicidality and anti­ depressant drugs cannot be established. 38 nevertheless, the research of the acn, the fda, and other groups that have studied the i8sue do not address ssri use in children and adolescents. the studies used by these groups focused almost exclusively on the effect of ssris in adults, and the data should not be simply applied to children without modification. instead, additional studies should be performed taking into account the important metabolic and physiological differences between children and adults. 39 33. id at 1112 (citations omitted). 34. /d. 35. /d. 36. /d. 37. miller, 196 f. supp. 2d at 1114 (quoting m. goldblatt & m. silverman. psychopharmacological treatment of suicidal patients, in review of suicidology 143-44 (r. maris, s. canetto, j. mcintosh, m. silverman eds., 1999). 38. miller, 196 f. supp. 2d at 1109. 39. see hazard, supra note 8. 206 indiana health law review [vol. 3:201 c. children 1. differences in testing/or children and adults testing of new or marketed drugs on children was not required by the fda until1997. 40 prior to 1997, the fda merely prohibited drug companies from marketing drugs for pediatric pwposes if they had not been tested on children for safety and efficacy.41 this regulatory scheme had an unintended dual effect; not only did it protect children from false and misleading claims on drug labels, but it also discouraged pharmaceutical companies from testing new drugs on children.42 as a result, there was very little, if any, information available to pediatricians prescribing drugs to children. the lack of information forced pediatricians to speculate on proper dosages or avoid prescribing a potentially beneficial drug altogether.43 particularized studies for pediatric patients are especially important because children undergo rapid metabolic and physiological changes, thereby creating a need to fine-tune dosages based on the rate of elimination of a drug from a child's system.44 despite the importance of pediatric studies, by the time the fda began addressing the problem, only twenty percent of drugs were labeled for use in children,· and six of the ten leading drugs prescribed by pediatricians had never been tested on children.45 ssris provide a terrific illustration of the inadequacies of such a system. despite a dearth of safety and efficacy data and an absence of guidelines for use in children, ssri prescriptions for children and adolescents have increased greatly in recent years.46 in fact, ssris have come to be viewed as safe and effective for children and are widely prescribed, notwithstanding their lack of approval for use in children. additionally, physicians prescribe ssris to children for a variety of psychiatric illnesses outside of the approved uses.47 as a result, children are placed in. the undesirable and dangerous position of de facto guinea pigs for pediatric experimentation outside the scope of a controlled and relatively safe drug trial.48 thus, children are less 40. hawd. supra ~ote 8, at 478. 41. id. 42. id. 43. id. 44.jd. at477. 45. hazard, supra note 8, at 418. 46. symposium, supra note 3, at 334-35. 47. ld. see food&. drug admin •• public health advisory, suicidalily in children and adolescents being treated· with antidepressant medications (oct. 15, 2004), http://www .fda.gov/cder/drug/antidepressants/ssripha20041 o.btm. ("among . . . antidepressants, only prozac is approved for use in treating mdd in pediatric patients. prozac, zoloft, luvox, and anafranil are approved for ocd in pediatric patients. none of the drugs is approved for other psychiatric indications in children.'') (last visited april14, 2006). 48. hazard, supra note 8, at 478-79. 2006] anti-depressants and children 207 likely to receive the most effective treatment available, and there is a lack of reliable efficacy data available to allow pediatricians to make the best and most informed choice when prescribing drugs. 2. recent developments of ssri use in children ssri use in children has come under heavy attack recently as several agencies have declared them unsafe for use in children. for example, new york attorney general elliot spitzer sued glaxosmithk.line, the maker of paxil, for withholding data that showed that paxil was ineffective for children. 49 most of the current interest in ssri use in children was spurred by the medicines and healthcare products regulatory agency's (mhra) (britain's equivalent to the fda) statement on june 10.2003 that the ssri seroxat (marketed as paxil in the u.s.) must not be used for treatment of children. 50 after reviewing data from clinical trials conducted by phar­ maceutical companies, the mhra's committee on safety of medicines (csm) concluded that for six of the seven ssris investigated, the risks of suicide and suicidal ideation outweigh any benefits in children with depression, and therefore ssris should not be used for pediatric patients. 51 after the mhraannouncement in june2003, the fda and other groups began taking a closer look at ssri use in children. twelve of fifteen subsequent studies of ssris failed to show that the drugs were effective in children. 52 initial studies on paxil appeared to suggest an increased risk of suicidal thoughts and actions in children who were given paxil when compared to children given placebos. 53 subsequent studies of other ssris indicated that children on these medications may also have an increased risk of suicidal thoughts and behaviors. 54 after reviewing the data from studies performed on all ssr.l drugs, the members of the fda psychopharmacologic drugs and pediatric advisory committees determined that the finding of an increased risk of suicidality in pediatric patients applied to all of the drugs studied in controlled clinical trials. ss the results from these studies led the fda to conduct one final study on suicidality combining results of twenty­ four smaller studies of children and teenagers who took either a sugar pill or 49. see jeffery krasner, sec focusing on drug makers; full disclosure oftests called key, bost. gl, sept. 27, 2004, at c4, available at 2004 wl 59807884. 50. symposium, supra note 3. 51. id. 52. olympian news services. fda. blocked data on children and antidepressants, sept. 10, 2004, http://www.antidepressants.com/2004-09-1 0-fda-blocked-ssri-data-kids.htm (last visited apr. 17, 2006). 53. fda, talk paper, supra note 10. 54. id. 55. food & drug admin., statement, fda statement on recommendations of the psychopharmacologic drugs and pediatric advisory committees (sept. 16, 2004), http://www.fda.gov/bbs/topicslnews/20041new01116.html (last visited nov. 21, 2004). 208 indiana health lawrevmw [vol. 3:201 antidepressants for one to four montbs.56 data collected from this study, known as the columbia study, showed that two children out of every hundred on placebos became suicidal, while four out of every hundred children on antidepressants became suicidal. s7 the results of this study were instrumental in the fda's ultimate decision to place a ''black box" warning on all ssri drugs; 3. columbia study a. method and results the· fda orgimized the columbia study because of concerns about whether the varied 'events identified in earlier studies as possibly suicide related could reasonably be considered to represent suicidality. 58 the original studies and clinical trials ofssris in pediatric patients lacked a systematic or standardized language to define suicidal behavior.59 ''this lack of standardized terminology for suicidal acts [made] it difficult to interpret the meaning of reported adverse events (aes) that occurred" in the original studies. 60 in order to. provide a more accurate account of suicidality, the fda needed to .ensure that definitions of suicidality in earlier studies were consistent with each other.61 to meetthe goal of consistent terminology, the fda asked columbia university to .assemble a panel of pediatric suicidality experts to undertake a blind review of the reported behaviors using a rigorous classification system.62 the tasks of the columbia study included identifying adverse events in previous studies "that were inappropriately classified as suicidal,'; or suicidal aes that were missed altogether, in order to avoid misinterpretation of the ssri trial data. 63 before interpreting the data, columbia study clinicians agreed upon terminology ''using research-supported definitions that [were] both valid (relevant features have been shown to be associated with the definition) and reliable (clinicians are able to use these definitions in similar ways)" for determining whether an ae was a suicidal event. 64 after agreeing on terminology and participating in training sessions, the members of the columbia study "systematically review[ ed] over 400 case descriptions from 56. fda proposed medication guide, supra note 53. 57. /d. 58. fda talk paper, supra note 10. 59. food & drug admin., background information on the suicidality classification project (mar. 22, 2004), bttp:/lwww.fda.gov/cder/druglantideplessants/classificationproject.hbn (last visited oct. 7, 2004). 60. id. 61. see fda talk paper, supra note i 0. 62. id. 63. bilckground information, supra note 59. 64. /d. 2006] anti-depressants and chrdren 209 the twenty-five pediatric trials .... "65 the columbia study reviewed "all events that were originally described ~ possibly suicidal, . . . coded as aecidental injuries, and all serious adverse events.'o66 after reviewing the events, the members of the study classified the eventsjn~o three categories: "suicidal events (suicide attempts, aborted attempts, ... interrupted attempts, and suicidal ideation-related events); non-suicidal events (self-injury or mutilation without suicidal intent, events attributable to other psychiatric symptoms, medical or accidental injuries); and indetenninate events (non­ consensus or unable to classify due to limited data).'>67 · the columbia study reanalyzed data from published and unpublished pediatric trials of ssris conducted between 1983 and 200 l. 68 after the columbia study finished reviewing the data from the pediatric trials, tareck hammad, an fda medical reviewer, analyzed the columbia research to assess the risk of suicidal tendencies. 69 hammad concluded: that minors given the nine antidepressants had been 1. 78 times more likely to have exhibited suicidal behavior than those taking placebos. the rate was significantly higher for some antidepressants, especially wyeth's effexor (4.97) and anglo-american glaxosmithkline plc's. paxil (2.65). hammad september 13 told. the advisory.panel that out of 100 minors taking antidepressants, two or ·three would become suicidal due to short-tei'dl use ofthe.drug .... the analyses by hammad and the columbia team backed up an earlier analysis by fda epidemiologist andrew mosholder, who in february [2004] had concluded that minors taking antidepressants were 1.89 times as likely to show suicidal tendencies. 70 as a result of the data from the columbia study, the fda determined that a "black box" warning was appropriate for ssri labels. 71 b. possible problems with the columbia study although the fda determined that "black box" warnings were appropriate based on the conclusions of the columbia study, the study still 65. /d. 66. /d. 67. /d. 68. medicine and health; fda backs child antidepressant warnings; other developments, facts on file world news dig., sept. 30, 20()4, at 756c3. 69. /d. 70. /d. 71. public health advisory, supra note 47. 210 indiana health law review [vol. 3:201 contained several flaws. to a large extent, the columbia study relied on data submitted to the fda from the drug companies themselves, and much of the data provided was incomplete. 72 in addition to incomplete data, reliance on data provided by drug companies could have other policy implications as well. by relying on data from the pharmaceutical companies, the fda left the door open to misleading and possibly false data designed to protect the companies • interests. 73 it is not an uncomn1on practice for pharmaceutical companies to emphasize favorable data while obscuring or excluding data that may be harmful to their ability to sell a drug, 74 thus stricter guidelines are necessary to allow the fda to properly interpret the available data. additionally, the very nature of the columbia study may have made it difficult to ensure that the results of the study were truly accurate. the very purpose of the study indicates that the columbia researchers were dealing with data that had serious shortcomings. 75 at the time the original data were compiled, the researchers ''were not looking for suicidal behavior as a possible adverse event."76 as a result it is likely thatmany incidents were not only incorrectly categorized, but not recorded at all. 77 since suicidality was not an expected effect of the drugs, it is unlikely that the original studies provided a control to determine the cause of the emergent suicidal ideation. 78 another factor that may reduce the accuracy of the columbia group's determination is the fact that drug-company trials often confuse self­ destructiveness with suicide attempts. 79 when determining whether an act is suicidal in nature or merely self-destructive, intent is the controlling factor. 80 if an individual lacks the intent to commit suicide, then the self-destructive act cannot be classified as suicidal in nature.81 "dr. thomas laughren, leader of the fda's psychiatric drug products group, noted that the [brief notes provided by the] drug companies . . . were often poor'' which made discovering the underlying intent difficult.82 as he stated,"[ w ]e did not have the level of detail in these cases that one would have liked to do a rational classification. "83 72. see fda study confirms link between antidepressants, child suicide, drugindust. dad.y, aug. ii, 2004, §156. 73. see liebert, supra note 9 ( discussinggjaxosmitbkiinewitbholding findings tbattheir ssri, paxil, was no more effective than placebo and may increase the risk of suicide). 74. /d. 75. see drug indust. dad.y, supra note 72. 76. /d. 77. see background information, supra note 59. 78. see drug indust. dad.y, supra note 72. 79. gardiner harris, antidepressants restudied for relation to child suicide, n.y. times, june 20, 2004, § 1 at 20. 80. /d. 81. /d. 82. /d. 83. /d. 2006] anti-depressants and children 211 another difficulty results from the diversified nature of the original trials. each pharmaceutical trial is unique in several ways that may compromise the integrity of the columbia group's determination. since each individual trial is focused for unique purposes, there is no single constant method utilized. dosages, methods of administration, and subject group will be almost as varied as the number of trials themselves.84 given the inherent differences in the original trials, it calls into question how the columbia researchers can be sure, after mere second hand review of clinical notes, that at least some of the adverse reactions were not caused by unusually high dosages, or another external factor, rather than the drug itself. how can one be sure that this collection and review of suboptimal data may be reduced to a concrete and conclusive result?85 4. new fda warnings relying on the columbia study's findings, the fda psychopharmaco­ logic drugs and pediatric advisory committees (pdpac) issued the following findings and recommendations to the fda: increased risk of suicidality in pediatric patients applied to all the drugs studied (prozac, zoloft, remeron, paxil, effexor, celexa wellbutrin, luvox and serzone) in controlled clinical trials; that any warning related to an increased risk of suicidality in pediatric patients should be applied to all antidepressant drugs, including those that have not been studied in controlled clinical trials ... ; [r]eached a split decision ... regarding recommending a "black box" warning related to an increased risk for suicid­ ality in pediatric patients for all antidepressant drugs; ... [r]ecommended that the products not be contraindicated in this country because the committees thought access to these therapies was important for those who could benefit .... 86 84. see andrew d. mosholder, m.d., m.p.h., review and evaluation of clinical data (sertraline) (aug. 13, 2002), available at http://www.fda.gov/cder/foi/esum/2004/ l9839se5_044_20990se5-0l0zoloft_mo_review2fin.pdf (last visited feb. 27, 2006); andrew d. mosholder, m.d., m.p.h., review and evaluation of clinical data (paxil) (oct. 7, 2002), available at http://www.fda.gov/cder/foi/esum/2004/20031 s037 _ paxil_clincal_bpca_fin.pdf(last visited feb. 27, 2006). 85. see, drug indust. daily, supra note 72. 86. statement on recommendations, supra note 55. 212 indiana health law review [vol. 3:201 the fda generally supported the findings of the pdpac and began working toward adopting new labeling with regard to ssris. 87 on october 15, 2004, the fda announced its new strategy to warn the public regarding the increased risk of suicidality in children and adolescents being treated with ssri med.ications.88 as of october 15, 2004, the fda began directing ssri manufacturers to place a "black box" warning on the drug label89 and that patients should be given a patient medication guide (medguide) "advis[ing] them of the risk and precautions that can be taken.'>90 black box warnings are the most serious warning labels available to the fda. when used, the drug manufacturer is restricted from certain actions. 91 for example, pharmaceutical companies maynotnm advertisements to remind health care professionals of a product's availability ifthe product carries a black box warning.92 until the issuance of a black box warning for ssri medications, only ten drug products approved for children contained a black box warning about their use in children.93 although the black box warning is serious, it is important to recognize that the fda does not prohibit the use of ssris in children and adolescents. the fda recognizes that the illnesses 87. id. 88. food and drug.admin., fda news. fda launches a multi·pronged strategy to strengthen safeguards for children treated with antidepressant medications (oct 15, 2004), available at http://www.fda.gov/bbsltopicslnews120041new01124.html. (last visited apr. 19, 2006). 89. public heal~ advisory, supra note 47. based on these data [ftom the "columbia" study], fda has determined that the following points ate appropriate for inclusion in the boxed warning: • antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with mdd and other psychiatric disorders. • anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with clinical need. • patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. • families and caregivers should be advised to closely observe the patient and communicate with the prescriber. • a statement regarding whether the particular drug is approved for any · pediatric indication(s) and, if so, which one(s). among the antidepressants, only prozac is approved for use in treating mdd in pediatric patients. prozac, zoloft, luvox, and anaftanil are approved for ocd in pediatric patients. none of the drugs is approved for other psychiatric indications ·in children. see public health advisory, supra note 47. 90. food & drug admin. news, supra note 88. 91. jd. 92. jd. 93. /d. 2006] anti-depressants and chhdren 213 ssris are designed to treat have serious consequences if not appropriately treated, but those taking ssris should be fully informed of the dangers. 94 ii. off-label uses currently, there is only one ssri, prozac, approved by the fda for treating children with mdd.95 in addition to prozac, three other ssri medications are approved for treating ocd in pediatric patients. 96 however, doctors have routinely prescribed these medications outside the scope of these approved uses in order to meet the best interests of their patients. this is known as "off-label use,'' which is defined as "[t]he use of a drug to treat a condition for which it has not been approved by the u.s. food and drug administration (fda), esp[ecially] when such use may relieve unpleasant symptoms, or prove compassionate. "97 since so few drugs are approved for use in children, the use of off-label prescribing is especially prevalent in the realm of pediatric care.98 while this may often be in the best interest ofthe child, it causes some confusion in determining who bears liability for the harmful effects of the drugs; the physician or the pharmaceutical manufacturer? a. history the role of the fda in the united states is to assess the safety and effectiveness of all drugs before they can be sold.99 unfortunately a large portion of drugs sold in the united states are avoiding fda scrutiny through off-label prescribing, basically prescriptions of unapproved uses. 100 this practice has become common if not the standard of care in many instances, 101 but places the patient at risk while offering no assurances that the drugs will work. 102 the fda drug approval process currently takes the following form: the fda must approve each drug marketed in the united states. once the ''new drug application" is filed, the 94. /d. 95. public health advisory, supra note 47. 96. /d. 97. tardyv. eli lilly & co., 2004 wl 1925536 at *1 n.3 (me. super. ct. 2004)( quoting taber's cycwpedic medical dictionary (f.a davis inc., 2002). 98. see hazard, supra note 8, at478. 99. adams & young, supra note 7. 100. /d. 101. see kaspar j. stoffelmayr, products liability and "off-label" uses of prescription drugs, 63 u. cln. l. rev. 275 (1996); ala. code§ 27-1-10.1 (2004); cal. ins. code§ 10123.195 (2004); conn. gen. stat. ann. § 38a-492b (west 2004); kan. stat. ann. § 402,167,2,170(2003);md.codeann.ins. § 15-804(2004). 102. adams & young, supra note 7. 214 indiana health law review [vol. 3:201 applicant must show that the proposed drug is safe and effective for its intended use. this is usually accomplished with the results of clinical trials. clinical investigators must be qualified, and the testing typically involves controlled experiments. the promoter of the drug must also submit a proposed label that will accompany the drug. if the application meets fda standards, the agency will approve the drug for the particular use or uses included in the application and will also approve the proposed label. this approval process is both extremely costly and time consuming. once the fda has approved a drug, the manufacturer may only market the product for the approved uses. because the fda-approved label must reflect those uses, any other use of the product is deemed "off-label." "misbranding," which includes off-label marketing, is prohibited by the fdca [food, drug, and cosmetic act]. these regulatory guidelines are complicated by an important feature of the law of off­ label use and promotion: physicians may prescribe drugs for non-approved or off-label uses. thus, a doctor may know that a particular drug is effective for one indication but only fda-approved for a different indication. in this common scenario, the doctor may prescribe the drug for the unapproved use, even though the manufacturer may not promote it for that use. 103 when a drug exhibits properties that have not been specifically proven in a clinical trial, these properties may be exploited through the use of off-label prescriptions for unproven uses. 104 this allows a drug company to profit from the use of the drug while avoiding the strict data requirements, rigorous scrutiny, and cost of the fda drug approval process. 105 off-label prescribing is a rapidly growing practice, or as some view it, a rapidly growing problem. it is estimated that nearly one-half of all american drug prescriptions are for off-label uses. 106 part of the reason for the growth of off-label prescribing is a lack of incentive for the drug manufacturers to seek approval for new uses for prescription drugs. seeking approval for new uses would likely have little effect on drug sales, so the 103. mark ford, another use ofoxycontin: the case for enhancing liability for off­ label drug marketing, 83 b.d. l. rev. 429,431-32 (2003). 104. tardy v. eli lilly & co., 2004 wl 1925536 at *1 n.3 (me. super. 2004)(quoting taber's cyclopedic medical dictionary (f.a. davis inc., 2002). 105. see id. 106. see stoffelmayr, supra note 101, at 275. 2006] anti-depressants and children 215 benefit to drug manufacturers does not outweigh the costs of the approval process.107 additionally, when new uses are discovered, less than the entire patent term remains for the drug. therefore, even with extended patent terms, it is difficult for a drug manufacturer to recover its investment in having an off-label use approved. 108 b. off-label prescriptions and children off-label prescribing encompasses more than simply using a drug for an unapproved use. one common form of off-label prescribing in children is when a drug is used for its approved use but in an unapproved patient population, such as when children are prescribed drugs approved for use in adults only.109 when prescribing off-label for children, physicians necessarily take a greater role in the administration of that drug. 11° for example, when prescribing off-label, physicians must calculate the proper dosage based on the patient's age and weight, and often the solutions must be compounded based on physician or pharmacist experience due to the absence of pediatric formulations. 111 the fda recognizes many of the inadequacies of prescribing guidelines for many drugs commonly used in children. 112 new standards have been developed to address some of these problems unique to the pediatric patient population, most importantly in the new drug application process. 113 in the past, manufacturers applied for approval for a new drug under the presumption that pediatric studies would not be conducted. however, new approval standards require manufacturers to explain why a pediatric study will not be conducted as part of the application process. 114 c. manufacturer vs. prescriber liability 1. off-label marketing there is a long history and tradition in the united states of restricting the claims manufacturers may make about their drugs in advertising. prior to the 1970s, regulations prevented manufacturers from marketing drugs to the 107. see id. at 277. 108. id. 109. id. 110. veronica henry, off-label prescribing legal implications, 20 j. legal men. 365, 380(1999). 111. id. 112. id. 113. ld. these new standards allow extrapolation from adult clinical trials and the use of pediatric pharmacokinetics (the study of the process by which a drug is absorbed, distributed, metabolized, and eliminated from the body) in formulating pediatric use guidelines. 114. ld. 216 indiana health law review [vol. 3:201 consuming public. rather, companies focused advertising on the doctors prescribing the drugs.115 in the early 1970s, however, the restrictions on direct promotion were lessened for the narrow purpose of providing price compari­ sons to consumers but did not allow advertisements to consumers to include any representations of the drug's safety, effectiveness, or indications.116 in the mid 1980s, the fda lifted the advertising moratorium on safety, effectiveness, and indications, 117 and by the 1990s, direct to consumer advertising became more commonplace. however, manufacturers are still subject to limitations on the claims they may make about their drugs. 118 of special importance to the issue of manufacturer or prescriber liability for off-label use of ssris in children are the provisions that prohibit manufacturers from advertising or promoting unapproved uses for their drugs, or including instructions for off­ label uses in the drug labels.119 these provisions are important because they 115. see peter barton hurr & richard a. melull, food & drug law: cases and materjals 465 (2d ed. 1991 ). 116. !d. 117. id. 118. advertising claims by manufacturers are subject to 21 c.f.r. § 202.1(e)(4) (year), which provides in part: (ii) in the case of an advertisement for a prescription drug other than a drug the labeling of which causes it to be an unapproved ''new drug" and other than drugs covered by paragraph (ex 4 xi) of this section, an advertisement may recommend and suggest the drug only for those uses contained in the labeling thereof: (a) for which the drug is generally recognized as safe and effective among experts qualified by scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) for which there exists substantial evidence of safety and effectiveness, consisting of adequate and well-controlled investigations, including clinical investigations (as used in this section "clinical investigations," "clinical experience," and "clinical significance" mean in the case of drugs intended for administration to man, investigations, experience, or significance in humans, and in the case of drugs intended for administration to other animals, investigations, experience, or significance in the specie or species for which the drug is advertised), by experts qualified by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses; or (c) for which there exists substantial clinical experience (as used in this section this means substantial clinical experience adequately documented in medical literature or by other data (to be supplied to the food and drug administration, if requested)), on the basis of which it can fairly and responsibly be concluded by qualified experts that the drug is safe and effective for such uses; or (d) for which safety is supported under any of the preceding clauses in paragraphs(ex4xiiixa), (b), and (c) of this section and effectiveness is supported under any other of such clauses. 119. stoffelmayr, supra note 101, at279. 2006] anti-depressants and children 217 serve as a basis for shifting liability of off-label uses from the prescribing physician to the manufacturer.120 despite the fda's safeguards, drug companies have become very successful in indirectly promoting off-label uses.121 generally, methods employed by the drug companies to promote off-label uses are well within what the fda allows, although some methods are considered less than ethical. some of the most common methods of promoting off-label use include: "funding research into off-label drug uses, sponsoring continuing education programs and symposia in which ostensibly independent researchers discuss off-label uses, distributing reprints of journal articles on off-label uses, and purchasing special journal supplements that feature articles about off-label uses."122 all of these methods are permitted by the fda as long as the drug manufacturers follow rules designed to ensure that the research remains objective.123 other restrictions upon drug manufacturers include regulations regarding shipment of drugs. it is illegal under federal law to ship a new drug interstate unless it is the subject of an approved new drug application.124 federal law defines a new drug as: "[a]ny drug ... not generally recognized, ... as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling .... "125 therefore, manufacturers face liability if a drug is shipped containing information regarding off-label uses. 126 it is important to remember that fda approval for a drug's shipment is limited to the intended uses as approved by the fda. 127 the intended use for a drug is not limited to the actual label on the packaging, but includes any statement in advertising, ''promotional material, or oral statements by the manufacture or 120. see richard heafey & don m. kennedy, product liabiuty: winning strategies and techniques (8th prtg. 2001) (discussing application of the learned intermediary doctrine). 121. stoffelmayr, supra note 101, at279-80. 122. id. at 280. 123. id. less ethical efforts by manufacturers to promote off-label drug uses include, for example, paying physicians to participate in sham "seeding trials," in which physicians prescribe off-label drug therapies as part of supposed scientific studies that in reality serve only to introduce participating physicians and their colleagues to the off-label uses. 124. 21 u.s.c.a. § 355(a) (west 2004); marsha cohen, commentary: can we talk? about food and drug regulation and the first amendment, 58 food & drug l.j. 741, 745 (2003). 125. 21 u.s.c.a § 321(p)(1) (west 2004). 126. cohen, supra note 124, at 745. stating: it is undisputed that if compound x has been approved in a 100 mg. dose, four times a day, for headache, it is illegal to ship compound x in a 200 mg. dose, or for use six times a day, or for nausea. a drug may be proven safe and effective for one use, but be neither safe nor effective for another. different uses are simply not interchangeable. 127. id. 218 indiana heal1h law review [vol. 3:201 its representative."128 as a result, manufacturers face liability for illegally shipping a drug if it advertises an unapproved use. 129 despite the liabilities imposed on manufacturers for advertising unapproved uses, these uses are far from illegal. in fact, the off-label uses are recognized by the fda and play a vital role in american healthcare.130 a manufacturer effectively limits its liability by following the fda guidelines in advertising. labeling, and promoting its drug. after the fda approves a drug for any use, the actual prescription choices are left to the discretion of the physician,131 thereby potentially placing liability for any ill~ffects for off­ label use on the prescribing physician. however, the liability may not shift to the physician if the manufacturer failed to adequately warn the physician of the risks. 2. failure to warn one dispositive issue in products liability cases against drug manufacturers is whether the manufacturer provided sufficient warning of the drug's risks. 132 manufacturers are only required to warn of risks of which they know or should know.133 however, this does not allow manufacturers to purposely remain ignorant of the risks of their product. in determining whether a drug manufacturer adequately warned of the risks, the court holds the manufacturer up as an expert in the field. 134 fda regulations also impose other duties upon manufacturers to discover the risks of the drug. 135 therefore, manufacturers are deemed to have constructive knowledge of all documented risks associated with the drug.136 in addition to being liable for failing to warn for risks of the drug, manufacturers have a duty to warn of foreseeable misuses of the drug. 137 this duty generally arises out of actions subsequent to the manufacturer's 128. /d. (quoting jonathan s. kahan & jefferey k. shapiro, the first amendment and the food and drug administration's regulation of labeling and advertising: three proposed reforms, 58 food & drug l.j. 353, 360 (2003)). 129. id. 130. huti&merill,supranote 115, at616-17 (noting, however, that although off-label uses often represent sound medical care they can be abused and "represent poor judgment ... or inadequate medical training."). 131. cohen, supra note 124, at 745. 132. stoffelmayr, supra note 101, at282. 133. /d. at 283. 134. /d. 135. /d. (manufacturers must "carefully motiitor reports from physicians-whether made directlytomanufacturersorpublishedinthemedicalliterature-regardinginjuriesrelatedtotheir drugs • . • • manufacturers also have a duty to conduct postmarketing studies on the safety of their drugs and to monitor for and investigate possible undetected risks. j. 136. /d. 137. heafey&kennedy,supranote 120. 2006] anti-depressants and clm.dren 219 production of the drug and can develop over time.138 such a duty arises when a drug is commonly prescribed for off-label uses, or when such uses constitute a substantial portion of the prescribed uses, 139 such as in treating cancer or aids.t40 the nature of "foreseeable misuse" often makes it difficult for drug manufacturers to adequately warn of certain risks. off-label uses of drugs develop over time, and therefore may not be expected or foreseeable at the time the drug is approved and marketed. as a result the approved labeling of the drug often does not adequately address common off-label uses of many drugs. however, drug manufacturers must receive fda approval for any changes made to the drug label and warning, even if the desired result is a stronger warning message.141 as a result, many of these off-label uses are not addressed and unnecessary harm results. this is because a manufacturer was unable to gain fda approval for new warning messages or the approval process caused significant delay. 142 138. liability for "foreseeable misuse" usually, but not always, develops <>ver time as doctors accumulate data from off-label prescriptions and scholarly journals indicating possible uses for a drug. .as a method of prescription gains acceptance over time the manufacturer may face liability under "foreseeable misuse." however, such liability may arise at the time the drug is introduced for marketing, and may be created by the drug company itself . .as one court noted, "[i]f the manufacturer negligently overpromotes its products, or downplays their dangerous effects, it will not be relieved ofliability for the foreseeable misuse of the drug and resulting injuries." evraets v.lntermedics intraocular, lnc., 34 cal.rptr.2d 852, 860 (cal. ct. app. 1994} (citations omitted). 139. anderson v. hedstrom corp., 76 f.supp.2d 422, 439-40 (s.d.n.y. 1999}(quoting liriano v. hobart corp., 700 n.e. 2d 303, 305, 307 (1998)} ("such a duty will generally arise where a defect or danger is revealed by user operation and brought to the attention of the manufacturer ... "). 140. daniel b. klein and alexander t. tabarrot, "who certifies off-label?'', regulation, vol. 27, no.2, p 60-63 (summer 2004). "most cancer and aids patients are given drugs that are not fda-certified for the prescribed use. 1n a large number of fields, a majority of patients are prescribed at least one drug off-label, and in some cases the off-label prescription is the •gold-standard' treatment" 141. see stoffelmayr, supra note 101 at285-86. 142. some of this difficulty can be seen in the reasoning and arguments found in needleman v. pfizer, lnc.: the fda has clearly determined that a warning linking zoloft and suicide would be false, misleading, and harmful to patients. plaintiffs' inadequate warning claim would thus conflict with the federal requirements imposed during the regulation of zoloft; in effect allowing a state regulation to impose labeling requirements contrary to those required by federal law .... plaintiffs' .. failure to warn claim" seeks to impose liability on pfizer for not including a warning in zoloft packaging that indicates a relationship between zoloft and suicide. 1n response. pfizer argues that such a statement would be considered .. false and misleading" by the fda, and would directly conflict with thefdca. see21 u.s.c. §355(d)(groundsforrefusinganewdrugapplication} needleman v. pfizer, lnc .• 2004 wl 1773697 at *2 (n.d. tex. 2004} (italics in original). trial lawyers of america, governing product safety: are government regulatory agencies doing 220 indiana heal1h law review [vol. 3:201 despite the duties placed on manufacturers to adequately warn of a drug's risks, plaintiffs still face a difficult road in seeking recovery. a plaintiff must prove two elements to recover on a failure to warn claim. the plaintiff must show that 1) the drug caused the injury; and 2) that a different or alternate warning would have changed the decision to prescribe the drug.143 it is often the second element that proves the most significant hurdle in drug manufacturer liability cases. even if the drug is proven to have caused the injury, the plaintiff must show that the warning provided by the manufacturer was relied upon. 144 there are two aspects to this element that make it difficult for the plaintiff to overcome: 1) who must rely on the warning (the choice of the word prescribe in the element suggests that it is the doctor who must be warned, which is discussed below); and2)proofofreliance. for example, a plaintiff may not recover if he or she did not read the included warning, even if that warning would have been inadequate if relied upon.145 3. learned intermediary doctrine the learned intermediary doctrine is very important in drug liability cases because it resolves the questions of who the drug company must warn and who must rely on that warning and it insulates the drug companies from liability for off-label prescriptions. under this doctrine, the drug company fulfills its obligations by informing the prescribing doctor of a drug's inherent risks.146 courts apply the learned intermediary doctrine on a case-by-case basis. however, it is applied almost universally in cases involving prescription drugs and medical devices because the doctrine takes into account enough to ensure that consumer products are safe? two anorneys from consumers union discuss the system's weaknesses and needed improvements, 40 trial 26, 28 (nov. 2004) ("fda regulations are the •ceiling' as wen as the •floor' of requirements for drug makers."). 143. see miller, 196 f. supp. at 1124 (2002). 144. seeid. 145. heafey & kennedy supra note 120 at§ 10.03; see also, motus v. pfizer, inc., 358 f.3d 659, 661 (9th cir. 2004) ("because the doctor testified that he did not read the warning label that accompanied zoloft or rely on information provided by [pfizer] ... the adequacy of pfizer's warnings is irrelevant .... [therefore] a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician."). 146. miller, 196 f. supp. 2d at 1121 (2002) (citing nichols v. cent. merch., inc., 16 kan.app.2d 65, 67, 817 p.2d 1131, 1133 (kan. ct. app. 1991)). 2006] anti-depressants and children 221 the complex role physicians play in the treatment of patients.147 as a result, this doctrine effectively relieves a manufacturer of liability. in the case of ssris, manufacturers may be relieved of liability even if they failed to adequately warn the medical community. 148 nevertheless, some courts have rejected the doctrine in cases involving drugs and medical devices for contraception and some vaccines.149 these courts have rejected the learned intermediary doctrine in cases involving contraception because the choice of contraception is personal rather than medical, thus the consumer is entitled to direct communication from the drug manufacturers in order to make her decision.150 the doctrine has not applied in cases where vaccines ''were administered to all comers in a 'clinic-type' setting without a physicians particularized weighing of the product's risks and benefits for each recipient •••• " 151 it is highly unlikely that courts will reject the learned intermediary doctrine for cases involving ssris because the typical ssri patient requires a physician's attention. · unlike the decision to use contraceptives, the decision to use an ssri is not primarily a personal choice. instead, ssris are used to treat serious medical conditions and diseases diagnosed by a physician, rather than as ways to avoid undesired circumstances. the treatment of depression is not simply a matter of the patient's will, but requires the consultation, consideration, and diagnosis of a medical professional. additionally, the need for diagnosis and physician directed treatment for depression and other ssri indications distinguishes the use of ssris from clinic-administered vaccines. for example, ssris are not administered en masse to the public like vaccinations during the flu season. unlike clinical vaccinations, ssris are prescribed only after proper diagnoses thereby providing the patient the benefit of the ''physician's particularized weighing of the product's risks and benefits for [that] recipient."152 147. with respect to drugs and medical devices, the prescribing physician is viewed as a "learned intermediary" whose specialized knowledge and experience enable him or her to evaluate the complex and technical information in the warning and assess the product's risks and benefits in treating a particular patient. application of the learned intermediary doctrine in the context of prescription products also reflects concern that direct patient warnings on prescription products would interfere with the doctor­ patient relationship. heafey & kennedy, supra note 120, § 10.03. 148. /d. (noting that if the prescribing physician did not rely on the warning, or was aware of the risk from other sources, the physician's conduct is considered the superseding cause that breaks the chain ofliability). 149, /d. 150. /d. 151. /d. 152. heafey&kennedy,supranote 120, § 10.03. 222 indiana hbalmlaw review [vol. 3:201 the learned intermediary doctrine places liability upon the prescribing physician. it is the physician's duty to adequately weigh the risks and rewards of a particular course of treatment when prescribing medication. whether the physician has met this duty depends not only oil the warnings provided by the manufacturer, but also the prevailing knowledge in the field. 153 for ssris, the prevalent knowledge in the field can play an important role because of the ongoing debate about ssris and suicidality. although much of the literature indicates that ssris do not cause suicidality, the vigorous and public nature of claims of a relationship between ssris and suicidality could serve to put a physician on notice beyond the warnings included on the drug label.154 although drug manufacturers may avoid liability through the learned intermediary doctrine, there are still complaints. surrounding manufacturers' decisions regarding clinical trials.155 the questions raised cast doubt on whether doctors and the fda are able to rely on clinical data as accurate representations· of the drug when choosing to prescribe. the drug or grant approval for marketing. controversy surrounding the publication of trial results bas been highlighted by ssri manufacturers who have chosen not to publish unfavorable clinical results . .,6 ill. clinical trials clinical trials are vital to the bealthcare industry for several reasons. these trials are the basis for fda approval, and they influence the physician's decision to administer a drug for certain indications .. companies are required by the fda to rigorously test new drugs to show that they are .safe, effective, and ready for marlcetiilg. therefore, a company's failure to disclose all information found in clinical trials can have ·a serious impact on the consuming public. this impact is especially true with the prevalence of off­ label uses since doctors rely on data from clinical studies in determining if an off-label use may be appropriate for a particular patient. with the debate surrounding ssris, it w8$ particularly disconcerting when glaxosmithk.line admitted in·2004 that.it.bad not revealed.clinical data suggesting their ssri, paxil, may increase the risk of suicidality in cbildren.157 to truly understand the impact of the decision of what a drug manufacturer does and does not 153. heafey & kennedy, supra note 120, § 10.03 (stating that drug manufacturers may not be hable ifthe physician is aware of the danger fiom another source). 154. stoffelmayr, supra note 101, at283 (arguing that manufiieturers have constructive, if not actual. knowledge ofadveme effeets clocumcnted in the field, perhaps this can also be applied to physicians who presaibe drugs that are widely speculated to pose a risk to a certain patient category). 155. see david bjerldie, putting trials on the record, time mao., july 5, 2004 at 42 (stating drug trial$ are misleading due to data that is left out). 156. liebert. supra note 9, at 567. 157. id. 2006] anti~depressants and children 223 publish, one must understand the approval process and the duties of the manufacturer. a. new drug approval before a manufacturer can introduce a drug into commerce it must gain fda approval for the intended use by showing the drug is safe and effective for its intended use.158 in order to show that the drug is safe and effective, the manufacturers must conduct clinical trials in controlled studies for the intended patient group. additionally, manufacturers must provide the fda with information regarding the method, population, and dosages of the clinical trial. at this stage of the testing, companies are required to provide the fda with data from all trials. still, the approval process remains flawed because until very recently, the fda did not require drug companies to test new drugs in pediatric populations.159 thus, the approval process left a void in an important area of fda concern. 158. (a) necessity of effective approval of application no person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an .application filed pursuant to subsection (b) or {j) of this section is effective with respect to such drug. (b) filing application; contents (l) any person may file with the secretary an application with respect to any drug subject to the provisions of subsection (a) of this section. such person shall submit to the secretary as a part of the application .. (a) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (b) a full list of the articles used as components of such drug; (c) a full statement of the composition of such drug; (d) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (e) such samples of such drug and of the articles used as components thereof as the secretary may require; (f) specimens of the labeling proposed to be used for such drug. the applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. if an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. upon approval of the application, the secretary shall publish information submitted under the two preceding sentences. the secretary shall, in consultation with the director of the national institutes of health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (a), and (g) any assessments required under section 355c of this title. 21 u.s.c.a. § 355 (west 2004). 159. hazard, supra note 8,at478~79. 224 indiana health law review [vol. 3:201 b. pediatric research the fda did not require pediatric testing of new drugs until 1997.160 instead, the fda attempted to ensure that the companies did not market drugs for pediatric use unless pediatric testing had been conducted. 161 unfortunately, this method did not adequately protect children because it deterred pediatric research rather than encourage it, even when the drug was widely used in pediatric populations through off-label use. 162 nothing was being done to ensure that off-:label uses were safe for children and very little research was done concerning the possible effects these drugs may have on a highly sensitive population. 163 under the earlier regulation scheme the fda's attempts to protect children were almost completely without effect. these early schemes included incentives for voluntary testing, and later, drug companies were only required to test a product in pediatric studies if they articulated a reason it would be used in children. therefore, virtually no burden was placed upon the companies to ensure pediatric safety, placing children in a figurative "black hole" in terms of clinical knowledge and regulatory protection. 164 manufacturers merely avoided marketing drugs to children and left room for off-label uses to fill the need for pediatric care, which resulted in children becoming "de facto research subjects ... deprived of the [protection] of the controlled supervision of a clinical trial."165 to address the problems presented by the regulatory scheme, the fda promulgated the "final rule" in j 997.166 this rule was composed of three parts (1) the rule applied to both new and marketed drugs widely used in children; (2) the fda "could require clinical data for all pediatric subpopulations;" and (3) if a manufacture met certain criteria, it could obtain a full or partial waiver for its product.167 under the final rule, if a manufacturer failed to conduct pediatric trials, the fda could deem the drug misbranded. 168 however, just prior to the promulgation of the final rule, i d. 160. ld. at 478. 161. id. 162. this regulatory approach evinced a shield and a sword on the marketplace. while protecting children from false or misleading claims on drug labels, it also deterred pharmaceutical companies from testing drugs on children. thus, pediatricians were left to speculate appropriate dosages to treat their young patients or otherwise avoid prescribing drugs altogether .... 163. /d. at 479. 164. see randall baldwin clark, 9 u. chi. l. sch. roundtable 1, speed, safety and dignity: pediatric pharmaceutical development in an age of optimism, 10-13 (2002). 165. hazard, supra note 8, at 478-79. 166. id at484. 167. /d. 168. /d. at489. 2006] ann-depressants and children 225 congress passed the food and drug administration modernization act of 1997 (fdama), which called for voluntary pediatric testing.169 the fdama sought to encourage pediatric testing by providing incentives to the manufacturer rather than threatening sanctions. 170 with the passage of the fdama, the fda's authority to promulgate the final rule was immediately called into question and fell into general non-enforcement until the court officially determined that the final rule was outside the bounds of fda authority. 171 unfortunately, the fdama did not adequately meet the needs that the final rule was promulgated to address. 172 as the fdama approached sunset, congress pushed for a new statute to take its place. in 2001, president bush signed the best pharmaceuticals for children act (bpca), the successor of fdama, into law.173 the bpca contains essentially the same requirements as the fdama and likewise did not provide the fda with the power necessary to protect pediatric patients. 174 therefore, congress sought to augment the bpca and in 2003, congress enacted the pediatric research equity act of 2003 (prea). 175 the prea codifies many of the provisions of the final rule and requires drug manufac­ turers to conduct pediatric testing for new drugs, unless the manufacturer can show that pediatric testing would be "impossible or highly impracticable," thus placing the burden on the manufacturer. 176 the implementation provides an interesting dichotomy in pediatric testing requirements; pediatric testing is not mandatory, but drug companies receive lucrative incentives for carrying out pediatric clinical trials. 177 still, the prea fails to address the serious risks posed by a lack of clinical data for off-label uses and does not present a final solution.178 169. see id. at485 170. hazard, supra note 8, at 484-86 (stating that fdama provides six month patent extension for manufacturers who conducted pediatric tests). 171. !d. at 489. 172. trial lawyers of america, supra note 142, at 28 {''pharmaceutical companies regularly violate[ d] [fdama which] requir{ ed] them to disclose clinical trials .... [i)n fact. the law has no enforcement mechanism and provides no penalties.''). source is not very neutral. 173. 21 u.s.c.a. § 355a (west 2004); hazard, supra note 8, at 493. 174. like the fdama, the bpca provides a six month patent extension in return for voluntary pediatric clinical testing. also, like the fdama, bpca provides a six month patent extension in return for voluntary pediatric clinical testing. also, like the fdama, ''the bpca ... maintain[ e] the voluntary incentive scheme" to encourage pharmaceutical companies to test more of their drugs on children, with the result of better labeling and greater therapeutic indications for pediatric populations. see hazard, supra note 8, at 491·2, 495. 175. 21 u.s.c.a. § 355c (west 2004); ld. at 500. 176. hazard, supra note 8, at 500. 177. !d. at 502 -03. 178. promulgation of the prea does not sufficiently remedy the shortcomings of the bpca. although pediatric clinical testing is now mandatory in new drugs, already marketed drugs may escape the burden of conducting research on children . . . while the prea ensures that the newest drugs will be tested on children, 226 indiana health law review [vol. 3:201 c. recent developments/required publication doctors and pharmacists rely on data from clinical trials when determining a course of treatment. data required for premarket approval is very reliable and widely available. however, when a manufacturer performs testing after the drug is approved, generally to determine secondary uses, a manufacturer may choose not to publish negative trials and provide the medical journals only with the data from the most attractive trials.179 thus, a large amount of clinical data is suspect, and may not provide physicians with a clear picture of the risks surrounding a medication. ·indeed, it has been noted that "one of the greatest roadblocks to understanding the safety and efficacy of trials is the lack of public access and . . . disclosure of these data sets .... "180 concerns over trial publication recently garnered more attention due to reports showing thatglaxosmithkline published reports on the success of its ssri (paxil), but withheld findings that the drug was no more effective than the placebo in pediatric populations and may increase the risk of suicide. 181 the fda did not recognize that ssris may cause suicidality in children and teenagers because drug makers were permitted to bury clinical trial results when outcomes were bad or inconclusive. this is exactly what happened when trials suggested a link between ssris and suicide.182 currently, there is a push from both congress and the nation's medicaljournals to require that drug companies publish all clinical trials. 183 in the wake of glaxosmithkline's admission and the fda's implementation of the black box label on ssris, several prestigious medical /d. at 503-04. pediatricians may still find a dearth of information on drugs the commonly prescribe ... moreover, combining the incentive structure of the bpca with the mandatory prea is contradictory ... congress has codified both mandatory and incentive-based initiatives ... in attempting to placate the pharmaceutical industry while addressing the problems of off-label prescribing for children, congress has created a legislative paradox: the law requires drug companies to test their products on children, and when they comply with the law, they receive a lucrative reward. it is the same perplexing logic that led the united states district court for the district of columbia to conclude that an incentive scheme and a "command and control approach" were incompatible, in striking down the fda final rule. 179. liebert, supra note 9. 180. symposium, supra note 3, at 338. 181. liebert, supra note 9. 182. tell the truth about antidepressants on drug labels and in medical journals, newsday, sept. 15, 2004, at a42. 183. missing drug data, wash. post, june 30, 2004, at a20. 2006] anti-depressants and children 227 journals184 began requiring drug companies to publicly register a trial before enrolling patients as a prerequisite for publication. 185 such a registration plan would fall short of requiring publication of all trial data, but could provide greater public awareness of trials and generate public concern if a large number of registered trials are not later published. 186 still, the efficacy of such an approach is questionable. registry systems are likely to inundate the public with more registered trials than can easily be sorted and identified. furthermore, the public may not know how to utilize the information for their safety, or worse, those who may effectively use the information may not even be aware of the system's existence. because they are implemented at the journal level, these registry systems are an excellent first step in fighting data suppression for several reasons. since they are implemented at the journal level, they are implemented quickly and efficiently, provide effective economic incentive to the manufacturers187, and can be done with relatively little cost. yet, due to the systems shortcomings it remains merely a first step. one possible way to augment the changes initiated at the journal level is with legislative action requiring drug companies to publish trial results. two bills have been introduced, one in the house and one in the senate, and each proposes a combined registry~publication system. 188 the purpose of these proposals has two elements, ( 1) ''to create a centralized and comprehensive" registry of clinical trials, and (2) "to make the information contained in the registry available to researchers, health care providers, patients seeking to enroll" in clinical trials, and the general public. 189 while the bills are slightly different, each seeks to meet these goals in essentially the same fashion. companies would be required to register their anticipated trials prior to commencement, provide an anticipated conclusion date, and update the registry with the results of the trial. 190 similarly, each bill seeks to enforce 184. see liebert, supra note 9 (mentioning the new england journal ofmedicine, annals oflnternal medicine, and lancet as being part of the group.) 185. newsday, supra note 179 ("companies can choose not to register trials, but that would mean forgoing the marketing boost of journal publicity."). 186. see bjerldie, supra note 1 55 ("a registry won't mean that every failed trial will be published, but it will make it clear that those trials.took place."). 187. inside the industry medical journals: editors to publish only registered trials, am. pol. network-am. heallll line, vol. 10 no. 9, sept. 9, 2004. 188. christopher rowland, bill to seek posting results of drug trials, under plan, fda could fine firms that fail to comply, boston globe, sept. 9, 2004, at dl; fair access to clinical trials act of2004, s. 2933, i08th cong. (2004); fair access to clinical trials act, h.r. 5252, i 08th cong. (2004). 189. s. 2933. 190. in general( i) conditions for financial awards. e~cept as provided in paragraph (2), an entity may not receive an award of a grant, contract, or cooperative agreement under this act for the conduct of a clinical trial to detennine the safety or effectiveness of a use of a drug or device (referred to in this section as a 'product') unless the responsible person for the trial228 indiana heal1h law review [vol. 3:201 the registry provisions through a combination of denying federal funding and imposing heavy fines. 191 each of these bills would be a terrific tool in protecting consumers, but neither successfully passed through committee. despite not overcoming this hurdle, these bills still provide a framework for how congress may deal with this issue in the future. the current legislative session may see similar legislation introduced. (a) agrees to register the trial with the secretary in accordance with subsection (dx1); (b) agrees to provide to the secretary information on the results of the trial in accordance with subsection (dx2); (c) agrees to the disclosme to the public of information regarding the trial ... h.r. 5252. 3) the data bank shall include a registry of clinical trials (whether federally or privately funded) in accordance with the following: (a) the registry shall include the information required under subparagraph (b) for all clinical trials conducted to test the safety or effectiveness (including comparative effectiveness) of any drug, biological product. or device (including those drugs, biological products, or devices approved or cleared by the secretary), except those phase i clinical trials conducted to test solely the safety of an unapproved drug or unlicensed biological product. the registry may include phase i clinical trials conducted to test solely the safety of an unapproved drug or unlicensed biological product with the consent of the responsible ~· for pwposes of tbis subparagraph, phase i clinical trials are trials described in section 313.12(a) of title 21, code of federal regulations (or any successor regulations). (b) the information required under this subparagraph with respect to the clinical trial involved includes the following: (i) a description of the purpose of the clinical trial, including the drug, biological product. or device to be tested. (ii) the eligibility criteria for participation in the clinical trial. (iii) a description of the location of trial sites and the start date of the trial. (iv) a point of contact for those wanting to enroll in the trial, including the identity of the responsible person. (v) the funding source or sources of the trial. (vi) the estimated completion date for the trial. for purposes of this section, the term 'completion date' means the date of the final collection of data from subjects in the 1rial for the outcomes described in clause (vii). (vii) a description of the primary and secondary clinical outcomes to be examined in the trial, the time at which the primary and secondary outcomes will be assessed, and the dates and details of any revisions to such outcomes. (viii) the actual completion date of the trial and the reasons for any difference from such actual date and the estimated completion date submitted pursuant to clause (vi). if the trial is not completed, the termination date and reasons for such termination. (ix) a summary of the results of the trial, including summary data tables, with respect to its primary and secondary outcomes as described in clause (vii), including information on the statistical significance or lack thereof of such results. (x) safety data concerning the trial (including a sutnmary of adverse events specifying the number and type of such events) . . s. 2933. 191. s. 2933 (imposing fines of up to $10,000 per day for every day of non-compliance after a thirty day notice period); h.r. 5252 (gxaxiiximposing the same $10,000 a day fine, but with $15,000 cap for non-profit organizations). 2006] anti-depressants and children 229 conclusion the current debate surrounding ssrl use in children is vital in many respects. ssris play an important role in pediatric care despite the fda's determination that ssri use in children may increase the risk of suicide. ongoing study of ssris in pediatric subjects will greatly reduce the risks associated with pediatric ssri use and may lead to the discovery of doses that are effective and safe for use in children. at this time manufacturers are not liable for adverse reactions to ssris as long as they do not promote off-label uses of these drugs and provide the physician with adequate warning. instead, the liability is appropriately placed upon the physician to seriously weigh the risks and benefits of the drug and share those determinations with the patient's parent( s) or guardian( s ). if, however, a drug company purposely prevented the dissemination of data pertinent to a physician's risk-weighing analysis, then the insulation of the physician should be terminated to allow recovery from the drug company itself. perhaps the most important aspect of the ssri controversy is how it illustrates the strengths and weaknesses of the current regulatory scheme. the fda's attempts to protect the consumer are often futile due to holes in the system; yet the holes, such as off-label prescribing, can play a vital role in health care and the advancement of medical treatment. such a paradox may never achieve a complete resolution, yet more can be done to fill these holes, whether through trial registry or some other form of regulation not yet contemplated. children deserve the same access to essential medications as adults. it is unfortunate that the recent fda recognition of a link between ssris and suicide may scare away many patients who could benefit from ssri treatment. adults have used ssris for many years and have experienced great improvement in their quality of life. there has been more than a decade of studies conducted on ssris that show that these drugs do not lead to suicide in adults, and only one secondary study showing a link between ssris and suicide in children. this difference can be attributed to the unique physiological and metabolic processes in children and adolescents, and more rigorous pediatric testing requirements may help determine the difference at an earlier point. through testing, an appropriate dosage level and treatment course could have been determined, which may eliminate the risk of suicidality. instead doctors were forced to "guess" in their treatment of childhood depression. the majority of the steps taken by the fda are necessary to ensure that children and parents are aware of the risks before they begin ssri treatment, yet some of the fda's actions may have been a little overzealous. the previous warnings on ssri labels indicated the inherent risks of suicide as a part of depression and urged close monitoring ofssri patients. by adding the 230 indiana health law review [vol. 3:201 black box warning, patients may be scared away from reaping the benefits of these drugs. in mandating the black box warning, the fda relied on the columbia study which undertook the daunting task of reanalyzing data from twenty-five studies on pediatric ssri use, each of which found no link between ssris and suicide in children. the columbia study results may be due to incomplete data and discrepancies between the methods used in the original studies (such as disparities in dosage: a study for sertraline used adult dosages while other studies used significantly decreased dosages}. in relying on the columbia study, the fda ignored years of research and may have acted too quickly. several ssris have already been approved for use in children with a variety of illnesses. while these drugs have proven safe and effective for their approved uses, the fda's decision may cause some children to forego the beneficial ssri treatment. history of the mcdonald-merrill­ ketcham memorial lecture and award the story of this award and lectureship begins with a visionary alumna of indiana university: dorothy m. ketcham. miss ketcham received her bachelor of arts in economics in 1914 and her master of arts in sociology the following year. she joined the faculty of the university ofmichigan in 1921. in 1922, she became director of social services at the university of michigan hospital. in this capacity, she saw the important role that medicine and law played in the lives of those whom she served. in 1928, she established a multifaceted workshop and recreational facility for children confined to the hospital. while at the university she also wrote several books, two of which are devoted to hospital law. miss ketcham's affinity for the law grew out of her family's close relationship with the legal system. her grandfather, david mcdonald, was a practicing attorney in indianapolis, as well as a circuit judge. he was appointed to the united states district court in 1864 where he served until his death. dorothy's father, william a. ketcham, was a well-known indianapolis attorney. prior to being admitted to the bar in 1869, he studied law with his father, john l. ketcham and judge david mcdonald. william ketcham was elected to the office of state attorney general in 1894 and served two terms. miss ketcham's interest in the health law extended beyond her scholarship. in a trust she established for herself and four of her sisters (miss flora mcdonald ketcham, dr. jane m. ketcham, and misses lilla and lucia ketcbam), she made a remainder gift to the indiana university foundation to be used to assist the university in developing programs that would foster a greater understanding and better relations between the professions oflaw and medicine. miss ketcham was especially in~sted in furthering the careers of young medical and law students and instilling in them an appreciation for both professions. miss ketcham's generous gift, named for her grandparents (judge david mcdonald, john l. ketcham and jane merrill ketcham), funds this prestigious lectureship and award for an individual who has demonstrated excellence in the fields of common interest to the two professions. it is fitting that the university honor miss ketcham's wishes by bringing to our campus distinguished scholars and leaders who bridge the gap between law and medicine. by inviting them to share their expertise with students, faculty and leaders of the legal and medical professions, we continue to support the ideals that dorothy m. ketcham espoused in her life and work. in recent years, the lecture and award have been made in collaboration with the medical humanities program, a new interdisciplinary project based in the school of liberal arts. this addition further integrates law and medicine into the academic community and· encourages each discipline to think of itself in relation to others. mcdonald-merrill-ketcham memorial lecture and award in conjunction with the indiana university school ofmedicine, the law school sponsors the annual mcdonald-merrill-ketcham memorial lecture­ ship and award for excellence in law and medicine. supported by a bequest to the two schools, this lectureship and award brings leading scholars and policy makers in the fields oflaw and medicine to the indianapolis campus for the benefit of students, faculty, the bar and the medical community. the inaugural program was held in november 1994. award recipients and their articles are listed below. articles based on the lectures presented were published in the indiana law review until 2002, at which time the lectures started being published in the indiana health law review. • 1994-tom l. beauchamp, professor of philosophy and senior research scholar at the kennedy institute at georgetown university. the justification of physician-assisted deaths, 29 ind. l. rev. 1173 (1996). • 1996-frances h. miller, professor oflaw at boston university school of law and professor of public health at boston university school of medicine. health care information technology and informed consent: computers and the doctor­ patient relationship, 311nd. l. rev. 1019 (1998). • 1997-troyen a. brennan, professor of law and public health at harvard school of public health and professor of medicine at harvard school of medicine. beyond dead reckoning: measures of medical injury burden, malpractice litigation, and alernative compensation models from utah and colorado, 33 ind. l. rev. 1643 (2000). • 1998-barry s. levy, immediate past president of the american public health association and adjunct professor of community health at tufts university school of medicine. twenty-first century challenges for law and public health, 32 ind. l. rev. 1149 (1999). • 1999-bemard lo, professor of medicine and director of the program in medical ethics at the university of california, san francisco. confidentiality of prescription drug information in the era of computers and managed care, 33 ind. l. rev. 937 (2000). • 2000--clark c. havighurst, william neal reynolds professor at the duke university school of law. the backlash against managed health care: hard politics make bad policy, 34 ind. l. rev. 395 (2001). • 2001-robert j. levine, professor of medicine and lecturer in pharmacology at yale university school of medicine. international codes of research ethics: cu"ent controversies and the future, 35 ind. l. rev. 557 (2002). • 2002-ruth r. faden, philip franklin wagley professor of biomedical ethics and executive dfrector of the phoebe r. berman bioethics institute at johns hopkins university. liberty, public health, and national security: the challengeofsmallpox, 1 ind. heal till. rev. 1 (2004). • 2003-h. tristram engelhardt, jr., professor of philosophy at rice university, professor emeritus in the department of medicine at rice university, and professor emeritus in· the department of community medicine at baylor college of medicine. giving, selling, and having taken: conflicting views oforgan transfer, lind. healtiil. rev. 29 (2004) .. • 2004-randall r. bovbjerg, research associate, health policy center, the urban institute, washington, dc. beyond tort reform: fixing real hoblems, 3 ind. heal till. rev. l (2006). physician employee non-compete agreements on the examining table: the need to better protect patients' and the public's interests in indiana kevin d. koons • table of contents i. introduction ••......••.....•.•...•••.....••.•..••.•...••••••..•••...••••.......•.....••.... 254 ii. background: employee non-compete agreements in the commercial context································································· 255 a. common law rule: covenants not to compete are per se invalid ...................................................................................... 256 b. modern "rule of reason": non-compete agreements are enforceable if reasonable ....................................................... 256 c. indiana's approach: the "rule of reason" ........................... 257 ffi. physician employee non-compete agreements ................... 258 a. approaches to the problem ...................................................... 258 1. modern commercial "rule of reason" ............................ 258 2. rule of per se invalidity .................................................... 259 3. intermediate approach: a stricter application of the "rule of reason" ......................................................................... 261 b. development of the standards for reviewing physician noncompete agreements in indiana .............................................. 263 iv. analysis: proposal for a more demanding review of physician restrictive covenants ........................................... 267 a. determine the genuinely legitimate, protectable interests of medical practice groups ......................................................... 267 b. full consideration of public interests affected by physician non-competes .......................................................................... 268 1. public interests favoring enforcement ............................. 269 2. public interests disfavoring enforcement ......................... 271 c. the circumstances surrounding the physician's departure ... 281 1. voluntary resignation or termination for cause ............. 282 2. bad faith termination ...................................................... 283 3. good faith termination without cause ........................... 284 d. consideration of the remedy sought ....................................... 285 1. liquidated damages .......................................................... 286 2. injunctive relief'. ................................................................ 286 • j.d. candidate, 2008, indiana university school of lawindianapolis; j.d., 2003, oak brook college of law and government policy. 254 indiana health law review [vol. 6:253 e. heightenedburden ofprooffor enforcement: clear and convincing evidence ................................................................ 287 v. conclusion •••••••••••••••••••••••••••••••••••••.••••••••••.••••••.••••••••••••••••..•••••••• 288 i. introduction the issues surrounding physician non-compete agreements1 highlight a clash of competing interests, rights, and individual freedoms. on one hand, enforcing physician covenants not to compete, there are the legitimate business interests of employers and physician practice groups to consider, as well as the freedom and sanctity of contract. on the other hand, society has an interest in promoting a free marketplace, in preventing monopolies, and in ensuring the fullest availability of professional medical assistance. additional considera­ tions favoring unenforceability are a physician's right to work and the interests of patients in choosing their own doctors, including the ability to follow their doctor to a different practice group. physician restrictive covenants appear in various types of agreements, in­ cluding employment agreements/ partnership agreements/ and agreements for the sale of a medical practice. 4 while restrictive covenants in these differing contexts raise discrete issues, 5 this note is limited to covenants not to compete that are incidental to physician employment agreements. in addition to a non­ compete clause, these employment agreements may also include a non­ solicitation of patients provision and a liquidated damages clause-or some combination of the three. 6 this note focuses primarily on the non-compete clause, although the other two elements are incidentally considered. with re­ spect to enforcement, employers will seek either injunctive relief to enjoin the 1. this note uses the terms "non-compete agreement," "covenant not to compete," and "restrictive covenant" interchangeably. 2. ferdinand s. tinio,annotation, validityandconstructionofcontractualrestrictions on right of medical practitioner to practice, incident to employment agreement, 62 al.r.3d 1014 (1975). 3. see, e.g., rash v. toccoa clinic med. ass'n, 320 s.e.2d 170 (ga. 1984); see also ferdinand s. tinio, annotation, validity and conslnlction of contractual restrictions on right of medical practitioner to practice, incident to partnership agreement, 62 al.r.3d 970 (1975). 4. ferdinand s. tinio, annotation, validity and construction of contractual restrictions on right of medical practitioner to practice, incident to sale of practice, 62 al.r.3d 918 (1975). 5. see, e.g., reed,robertsass'n,inc. v. strauman,353 n.e.2d590(n.y. 1976)(cove­ nant not to compete ancillary to sale ofbusiness ). restrictive covenants that are ancillary to the sale of a business have different objectives than covenants ancillary to employment agreements. for a discussion of the difference between the objectives of an employee non-compete agree­ ment and that of the seller of a business, see harlan m. blake, employee agreements not to compete, 73 h.ar.v. l. rev. 625, 646--47 (1960). 6. for an example of a physician restrictive covenant that included all three elements, see sharvelle v. magnante, 836 n.e.2d 432, 434-35 (ind. ct. app. 2005). 2009] physician empwyee non-compete agreements 255 activities prohibited by the restrictive covenant or, if the contract includes them, liquidated damages. until recently, the indiana supreme court had confronted physician non­ compete agreements only once in its 1983 decision of raymundo v. hammond clinic association.' the raymundo court upheld the physician non-compete agreement without much thought to the public interests implicated by such agreements. 8 in 2008, central indiana podiatry, p. c. v. kruege? presented an opportunity for the indiana supreme court to revisit the issue. in the interven­ ing twenty-five years between raymundo and krueger, other jurisdictions be­ gan to scrutinize physician non-competes more closely than non-compete agreements in other contexts. for example, in 2005, the tennessee supreme court forged a new path by declaring that physician non-compete agreements are per se invalid in violation of public policy.10 other states adopted statutes prohibiting or severely limiting physician non-compete agreements. 11 in krueger, however, the indiana supreme court declined to join those jurisdic­ tions that hold physician non-compete agreements to a higher standard of re­ view. the purpose of this note is to explore and evaluate possible standards for reviewing physician restrictive covenants and to suggest an analytical frame­ work for this issue. part ii of this note gives a brief overview of the standards that courts have traditionally applied to non-compete agreements in ordinary commercial contexts. part m discusses and evaluates the three primary ap­ proaches--including indiana's approach-that courts use to analyze physician restrictive covenants. part iv proposes an analytical framework and various factors for subjecting restrictive covenants to more rigorous scrutiny in light of the important public interests at stake. ii. background: employee non-compete agreements in the commercial context it is difficult to appreciate the problem of non-compete agreements in the specific context of physician employees without first considering how courts evaluate the validity of employee non-compete agreements in general commer­ cial contexts. briefly reviewing the development of the law of noncompete agreements in the commercial setting will give an appropriate context for ex­ amining noncompete agreements as applied to physician-employees. an over7. 449 n.e.2d 276 (ind. 1983). 8. id. at 280. 9. 882 n.e.2d 723 (ind. 2008). 10. murfreesboro med. clinic, p.a. v. udo:m, 166 s.w.3d 674,683 (tenn. 2005). the tennessee general assembly, however, responded in 2007 by enacting legislation to pennit physician non-compete agreements with certain specified limitations. tenn. code ann. § 63-1148 (2007). 11. see, e.g., del. code ann. tit 6, § 2707 (enacted in 1993); colo. rev. stat. ann. § 8-2-113(3) (enacted in 2003); mass. gen. laws ann. ch. 112, § 12x (enacted in 1991). 256 indiana health law review [vol. 6:253 view of this development follows. 12 a. common law rule: covenants not to compete are per se invalid restraints on trade the use of covenants not to compete is not a new phenomenon. some of the earliest cases at english common law date back to 1414, holding that an employee's covenant not to compete was per se void, as were all restraints on trade.13 this early line of cases involved apprentices or journeymen who faced '"unethical' masters attempting to prolong the traditional period of [training]."14 in contexts other than employment, common law courts began to uphold "partial" restraints on trade, namely, restrictions that had a limited scope of prohibited activities or geographic restriction.15 these cases, however, in­ volved covenants not to compete that were incidental to the sale or transfer of a business.16 b. modern "rule of reason": non-compete agreements are enforceable if reasonable covenants in restraint of trade are still disfavored today, yet courts are willing to enforce them if they are reasonable.17 to qualify as ''reasonable," the covenant must (1) be no greater than necessary to protect the employer's inter­ ests, (2) not impose an undue hardship on the employee, and (3) not harm the public. 18 commonly recognized protectable interests include the goodwill that the employer has built among its customers as well as any confidential information that the employer imparted to the employee during his employment.19 if the employer can identify a legitimate interest worthy of protection, courts next consider whether the covenant is no broader than necessary to protect that in­ terest, considering any (1) time limitations, (2) limitations on the scope of pro­ hibited activities, and (3) geographic limitations on the covenant's reach.20 12. the full history and development of the law concerning general employee non­ compete agreements is beyond the scope of this note. for a thorough discussion of the law's development, see blake, supra note 5. for a similar discussion specific to indiana law, see john w. bowers, stacey l. katz & charles w. back, covenants not to compete: their use and enforcement in indiana, 31 val. u. l. rev. 65 (1996). 13. blake, supra note 5, at 631-37. 14. id. at 632. 15. jd. at 632, 635. 16. jd 17. licocci v. cardinal assocs., inc., 445 n.e.2d 556,561 (ind. 1983). 18. blake, supra note 5, at 648--49 (citingrestatement{first)ofcontracrs §§ 51315 (1932). 19. see generally id at 651-74 (discussing commonly recognized protectable business interests). 20. e.g., dicen v. new sesco, inc., 839 n.e.2d 684, 688 (ind 2005). 2009] physician employee non-compete agreements 257 although the traditional formulation of the rule requires courts to consider all three factors (i.e., employer's interests, hardship on the employee, and injwy to the public), most courts consider only whether the covenant seeks to protect some legitimate business interest, almost to the exclusion of the other two fac­ tors. 21 considerations of hardship on the employee or ofinjwyto the public are often subsumed in the courts' evaluation of the first factor.22 as one scholar has noted, this almost exclusive focus on an employer's protectable interest "does not mean that the interests of the employee and the public are necessarily slighted, but only that 'undue hardship' to the employee and 'injury' to the pub­ lic are measured against the urgency of the employer's claim to protection, ra­ ther than against some extrinsic standard.'.23 this approach may suffice where the public interests at stake are limited either to economic interests (such as the need for efficient business operation and the large-scale economic costs of li­ miting an employee's right to work) or to social concerns that relate to econom­ ic interests (such as the sanctity of contract and an employee's right to work). 24 after all, the employer's protectable interests generally relate to its own eco­ nomic concerns. but where the public has an interest in other, non-economic concerns, such as public health, welfare, or safety, these interests should not be collapsed into the "legitimate employer interest" factor. rather, decisional transparency, analytical clarity, and public confidence in the judiciary require courts to engage in a separate and deliberate evaluation of the covenant's effect on the public's non-economic interests. c. indiana's approach: the "rule of reason" like other jurisdictions adopting the modern rule, the touchstone oflndi­ ana' s inquiry into the validity of a covenant restraining trade is the covenant's reasonableness.2s in considering what is reasonable, indiana courts likewise consider the three factors of (1) whether the covenant's scope is broader than necessary to protect the employer's legitimate interests, (2) the hardship upon the employee, and (3) the effect upon the public's interest.26 physician em­ ployee non-compete agreements 21. blake, supra note 5, at 649-50. 22. id at 684-87. 23. id at 650. 24. id at650-51. 25. see donahue v. permacel tape corp., 127 n.e.2d 235, 239 (ind. 1955) (quoting wiwston on contracts, § 1636, at 4580-81 ). 26. id 258 indiana healm law review [vol. 6:253 ill. physician employee non-compete agreements a. approaches to the problem in the context of physician employee covenants not to compete, courts will at least recite the traditional formulation of the rule. the cases, however, often diverge on how or whetlier to apply the third factor, which involves the covenant's effect on the public's interest. at one end of the spectrum, some courts continue to gloss over the traditional "public interest" factor when ana­ lyzing physician non-compete agreements. they focus instead on whether the scope of the covenant is broader than necessary to serve the employer's protect­ able interests. 27 at the other end of the spectrum, at least one court has held that an employer's protectable interests can never outweigh the public's interest in the free availability of a physician's services. 28 within this spectrum, the approaches to physician non-compete agree­ ments can be generalized into the following categories: (1) the modem "rule of reason" as applied in general commercial contexts, where the ''public interest" factor is essentially subsumed in the analysis of the covenant's relationship to the employer's protectable interest, (2) a rule of per se invalidity based on a policy judgment that any restrictions on the right to practice medicine are in­ imical to the public interest, and (3) an intermediate approach that more strictly applies the ''rule of reason" by separately and deliberately analyzing and weigh­ ing the covenant's effect on the public interest. each of these approaches is briefly discussed below. i. modern commercial "rule of reason" although courts frequently recite all three factors that comprise the tradi­ tional formulation of the test for the enforceability of non-compete agreements, in practice they analyze only the first factor and gloss over, if not altogether ignore, the public interest factor when evaluating physician non-compete agreements. 29 some courts follow this approach even in the context of physi­ cian non-compete agreements without stopping to consider the breadth of inter­ ests that such agreements implicate.30 as noted above, if the public's interests are limited to economic concerns, the public interest may be adequately represented in the "legitimate employer interest" factor of the test.31 but physi27. see, e.g., raymundo v. hammond clinic ass'n, 449 n.e.2d 276,281 (ind. 1983) (summarily dismissing as "self-serving'' physician employee's argument that the public need for medical services is great). 28. murfreesboro med. clinic, p .a. v. udom, 166 s.w.3d 674,683 (tenn. 2005). 29. see, e.g., raymundo, 449 n.e.2d at 281 (summarily dismissing as "self-serving" phy­ sician employee's argument that covenant should not be enforced due to the public interest in the availability of medical services). 30. ld. 31. see supra notes 21-24 and accompanying text. 2009] physician employee non-compete agreements 259 cian non-compete agreements affect a much broader range of interests than economic concerns alone. the potential public effects of such agreements in­ clude reducing the availability of medical services in the restricted geographic area and impeding a patient's ability to seek continued care from a treating phy­ sician. that is not to say, however, that economic concerns are absent in physi­ cian restrictive covenants. rather, the public health and welfare concerns are in addition to the same social and economic effects that are found in all commer­ cial employee non-compete agreements. because the public effects of physi­ cian non-compete agreements are broader than the public effects of general commercial non-compete agreements, courts should not merely subsume the "public injury'' inquiry in its evaluation of the employer's legitimate protectable interest when analyzing the reasonableness of a physician restrictive covenant. instead, the covenant's effect on the public health and welfare should be given its own due consideration. 2. rule of per se invalidity while some courts apply the "rule of reason" without adequately consi­ dering the covenant's effect on the public good, others have advocated an ap­ proach at the opposite extreme. these courts at the opposite extreme hold that all physician restrictive covenants are per se unenforceable as being against the public interest. 32 this approach has the advantages of recognizing the cove­ nant's adverse effects on the public interest and maintaining the certainty that accompanies bright line rules. this certainty allows both physician practice groups and the doctors they employ are able to arrange their respective business relationships without speculating whether a restrictive covenant will be en­ forced. as with many bright line rules, the problem with this approach is that its one-size-fits-all solution may not always be appropriate. not all physician non­ compete agreements pose the same threat to the public good. in fact, some physician non-compete agreements may arguably further the public's interest in making medical services as widely available as possible. for example, some geographic areas are medically underserved while others have an adequate supply of physicians, if not a surplus. 33 if a physician is already located in an 32. see, e.g., murfreesboro, 166 s. w.3d at 684, superseded by statute, act of june 21, 2007,cb. 487, § 1, 2007 tenn. pub.acts,ch.487,§ 1 (codifiedattenn.codeann. §63-1-148 (2007)); gomezv. cbuamed. corp., 510n.e.2d 191, 197-98 (lnd ct app. 1987)(sullivan, j., concurring); s. file 210, 74th gen. assem. (iowa 1991 ), available at bttp://contentdm.legis. state.ia.us/cdm4/documentpbp?cisoroot=n4bills&cisoptr=14440&rec=1 (vetoed by the governor on june 5, 1991 ); paula berg, judicial enforcement of covenants not to compete between physicians: protecting doctors 'interests at patients' expense, 45 rutgersl. rev.1, 48 (1992). 33. at the writing of this note, only twenty-five of indiana's ninety-two counties do not contain a ''medically underserved" or ''health professional shortage" area, as determined by the u.s. department ofhealth and human services. u.s. dep'tofiiealihandhuman serv., 260 indiana health law review [vol. 6:253 adequately served area, enforcing his non-compete agreement could force him to move into a medically underserved area. 34 thus, enforcing the restrictive covenant in such cases would actually better serve the public's interest in mak­ ing the physician's services more widely available to areas that have greater need of them. this view, however, is tempered by (1) the reality that these cir­ cumstances probably arise rather infrequent1~5 and (2) the highly speculative nature, even in a concrete case, of determining whether the physician employee would actually move to a medically underserved area as opposed to moving to another adequately served area. 36 thus, these observations suggest that a per se rule of invalidity is not the preferable approach. a health care employer's reliable access to the restrictive covenant device arguably increases the availability of medical services in another way. if re­ strictive covenants are off limits to health care employers, they may be less will­ ing to employ additional physicians, particularly younger physicians who need to develop a practice but may not be in the position, financial or otherwise, to enter a particular medical market. 37 therefore, preventing health care employers from using restrictive covenants could actually decrease the availability of med­ ical services. but if they can protect their investment in additional employees through the use of restrictive covenants, the public's access to medical services would be increased. the question in any given case would be: to what extent will the unavailability of the restrictive covenant actually discourage employers from hiring additional physicians? and, assuming such effects could be meas­ ured, how do they compare with any current physician shortages (or surpluses) in the subject geographic area? as these issues demonstrate, the one-size-fits­ all approach ofboth the modern commercial .. rule ofreason" and the .. rule of healtii res. and serv. admin., healtii professional shortage areas, http://hpsafind.hrsa.gov/hpsasearch.aspx (search "indiana," "all counties," and "primary medical care") (last visited nov. 10, 2007) [hereinafter healtii professional shortage areas]; u.s. dep'tofhealtiiandhumanserv.,healtiires.andserv.ai>min.,medically underserved areas, http://muafind.hrsa.gov/index.aspx (search "indiana" and "all counties") (last visited nov. 10, 2007) (hereinafter medically underserved areas]. 34. rash v. toccoa clinic med. ass., 320 s.e.2d 170, 173-74 (ga. 1984) (recognizing that enforcing a physician restrictive covenant would equally afford people in other areas the opportunity to have the services of another-physician available in their locale). 35. at the writing of this note, more than two-thirds of indiana's counties are classified by the u.s. department of health and human services as either a "medically underserved area" or a "health professional shortage area" for the discipline of "primary medical care." heal til professional shortage areas, supra note 33; medically underserved areas, supra note 33. 36. while a court could restrain the physician-employee from practicing within the geo­ graphic area that is subject to the restrictive covenant, it is unlikely that a court would have the authority to coerce the physician to practice in a medically underserved area against his or her will. 3 7. for example, physicians who are just starting their careers most likely do not have the patient base or financial resources to open their own practice. these younger physicians may need to join an existing practice in order to develop the financial resources and patient base needed to open a practice. an existing practice group, however, may not be willing to hire a young physician without some assurance that the physician-employee will not leave the practice until the physician-employee has generated enough revenue to cover the practice group's ex­ penses and produce a profit. 2009] physician employee non-compete agreements 261 per se invalidity'' oversimplifies the solution to an exceedingly complex and sensitive problem. 3. intermediate approach: a stricter application of the "rule of reason" several state courts have attempted to develop an intermediate approach in an apparent response to the problems inherent in the two previous approach­ es. these courts give greater attention to the public policy concerns-other than economic interests-that physician restrictive covenants implicate. in val­ ley medical specialists v. farber,38 the arizona supreme court expressly de­ clined to consider a rule of per se invalidity for physician restrictive covenants39 and held that physician restrictive covenants must be "strictly construed for rea­ sonableness.'.40 in strictly scrutinizing the restrictive covenant, the court sepa­ rately and fully considered the public interests surrounding the highly sensitive and personal relationship between patients and physicians,41 noting that physi­ cian restrictive covenants could not be compared to similar commercial cove­ nants.42 in iredell digestive disease clinic, p.a. v. petrozza, 43 the north carolina court of appeals also rejected a per se rule of invalidity, instead holding that the restrictive covenant is unenforceable if it creates a "substantial question of potential harm to the public health ... .'.44 the court stated that due to the high­ ly personal relationship between physician and patient, it was "extremely hesi­ tant" to deny the patient-consumer a choice of physicians.45 this "extreme hesitance" manifests the court's view that physician restrictive covenants must be subjected to stricter scrutiny under the traditional formulation of the rule than general commercial restrictive covenants. similarly, in ohio urology, inc. v. pol1,46 the ohio court of appeals ex­ pressly rejected the trial court's ruling that all physician noncompetition cove­ nants are per se unenforceable.47 the court recognized, however, that while all anti-competitive agreements are disfavored, physician non-compete agreements affect the public interest more significantly than general commercial non­ compete agreements.: "[the] measure of disfavor is especially acute concerning restrictive covenants among physicians, which affect the public interest to a much greater degree. '.48 the ohio urology court acknowledged a variety of 38. 982 p.2d 1277 (ariz. 1999). 39. /d. at 1283 n.l. 40. /d. at 1283. 41. /d. at 1285. 42. /d. at 1283. 43. 373 s.e.2d 449 (n.c. ct. app. 1988). 44. /d. at 453 (emphasis added). 45. ld at 455. 46. 594 n.e.2d 1027 (ohio ct. app. 1991). 47. /d. at 1033. 48. id at 1031. 262 indiana health law review [vol. 6:253 public interest concerns, including (1) the american medical association's ("ama") express ethical opinion discouraging the use of restrictive covenants, (2) the importance of competition in physician services in times of skyrocketing health care costs, and (3) the expectations of patients, who would have no rea­ son to know the specifics of a doctor's private employment agreements. 49 the approach reflected in these cases involves a more exacting review of physician restrictive covenants to ensure that (1) the employer is truly seeking to protect only legitimate business interests/0 (2) the restrictive covenant is nar­ rowly tailored to achieve those interests, 51 and (3) the public interests, especial­ ly noneconomic concerns, are thoroughly vetted and balanced. 52 this stricter review gives the proper attention to important noneconomic public concern that the modem general commercial approach neglects. moreover, unlike the per se invalidity approach, it gives employers the chance to show (albeit under a heavier burden than in the general commercial context) that the restrictive co­ venant is necessary lo protect their legitimate business interests. admittedly, this intermediate approach lacks the certainty that the ''per se invalid" rule provides. this shortcoming, however, should not be fatal for sev­ eral reasons. first, many factor tests exist in employment law, and litigants in this area should be somewhat conditioned to their use. 53 second, any uncertain­ ty inherent in the law might induce parties to resolve their disputes out of court rather than resort to expensive (and uncertain) litigation. third, physician prac­ tice groups may be less likely to use restrictive covenants-qr perhaps even be less likely to enforce existing restrictive covenants-if they face an uphill battle to prove the reasonableness of their agreements coupled with the uncertainty of litigation. given the "acutely disfavored'' status of physician restrictive cove­ nants, 54 this is not a bad result. while a more exacting review of restrictive co­ venants will eliminate a larger number of "acutely disfavored" agreements, it nonetheless allows employers to use such covenants where necessary and en­ courages them to draft their covenants more narrowly. 49. ld at 1031-32. 50. see infra part iv .a. 51. see infra parts iv.a, c and d. 52. see infra part iv.b. 53. see, e.g., harris v. forklift sys., inc., 510 u.s. 17, 24-25 (1993) (scalia, j., concur­ ring) (noting the lack of clarity in the majority's factorial test to determine the existence of a hostile work environment but concurring nonetheless because no better alternative test exists); moberly v. day, 757 n.e.2d 1007, 1009-10 (ind. 2001) (applying a ten-factor test for distin­ guishing employees from independent contractors); gkn co. v. magness, 744 n.e.2d 397,402 (ind. 2001) (establishing a seven-factor test for determining whether a person is an employee of two different employers). 54. see, e.g., ohio urology, 594 n.e.2d at 1031. 2009] physician employee non-compete agreements 263 b. development of the standards for reviewing physician non-compete agreements in indiana a proper appreciation for the treatment of physician non-compete agree­ ments in indiana begins, not with jurists, but with indiana's medical communi­ ty. nationally, the medical profession has been debating the ethical propriety of physician restrictive covenants for the last seventy-five years.55 within that debate, hoosier physicians have advocated the view that any physician restric­ tive covenant is wholly unethical. in 1971, the indiana delegation to the ama house of delegates "introduced a resolution that unequivocally declared that restrictive covenants were unethical. "56 the full ama house of delegates, however, rejected the indiana delegation's proposed resolution; instead, it for­ mally adopted an ambivalent "discouragement" of restrictive covenants. 57 the law in indiana, however, has not coincided with the opinions of its medical ethicists. when the indiana supreme court first tackled the issue in raymundo v. hammond clinic association in 1983,58 the court failed to con­ sider the position of the indiana medical community. in raymundo, dr. ray­ mundo joined a fifty-physician clinic as part of its four-yearpartnership track. 59 the clinic's agreement with dr. raymundo provided that he would be subject to a two-year restrictive covenant should he leave the clinic before he became a full partner.60 the agreement further provided that ifdr. raymundo violated the restrictive covenant, the clinic would be entitled to liquidated damages of $25,000 if the violation occurred during the first year of the two-year period and $15,000 if the violation occurred during the secondyear.61 two years after joining the clinic, dr. raymundo withdrew and started an independent practice in the restricted area.62 upon dr. raymundo's violation of the restrictive covenant, the clinic sued both to enjoin dr. raymundo from violating his non-compete agreement and to recover liquidated damages. 63 by the time the case reached the indiana supreme court, the two-year contractual ban on competitive activities had al­ ready expired. 64 because the two-year restrictive period had expired, the ray­ mundo court held that the injunction issue was moot 65 thus, raymundo 55. berg, supra note 32, at 6-7. 56. id. at7. 57. id. 58. 449 n.e.2d 276, 281 (ind. 1983) ("it appears that the enforceability of non­ competition covenants has not been previously decided in this state, with respect to physi­ cians.") 59. id. at 278 60. id. 61. id. 62. id. 63. id. at278-79. 64. ld. 65. id. ("[w]earehereconcernedonlywith the [claim] seeking damages, [the claim seek­ ing injunctive relief] having become moot with the passage of time, during the pendency of the 264 indiana health law review [vol. 6:253 expressly presented only the enforceability of the restrictive covenant's liqui­ dated damages provision rather than the clinic's right to enjoin dr. raymundo's practice of medicine.66 the raymundo decision is fraught with decisional opacity. the court ap­ plied the modern test that courts apply generally to commercial restrictive co­ venants but failed to thoroughly discuss the public policy interests at stake. 67 rather, it characterized dr. raymundo's public policy argument as an egotistic­ al "suggest[ ion] that ... he is, somehow entitled to special treatment, because he is a physician and there is great need for his services.'a the court then sum­ marily dismissed this argument merely as a "self-serving" position.69 finally, the court concluded that physician covenants not to compete ''have been upheld generally in other jurisdictions" but provided no authority to support this state­ ment.70 although the restrictive covenant at issue in raymundo was incident to a partnership agreement, rather than an employment agreement, 71 subsequent in­ diana decisions have applied raymundo's standards to employment agreements as well. 72 despite the lower courts' faithful application of raymundo to physi­ cian restrictive covenants, many decisions have invalidated such covenants on the facts before them. 73 four years after raymundo, the indiana court of appeals, in gomez v. chua medical corp., recognized raymundo's apparent shortcomings and urged the indiana supreme court to reexamine and overturn raymundo: "[i]t is not inappropriate, i think, to hope for our supreme court to conduct a reexamina­ tion of its earlier-stated view [in raymundo] that the freedom of contract must remain inviolate even if the public policy is disserved."74 not willing to drop the matter, the indiana court of appeals again expressed disagreement with action in the trial court .... "). 66. id 67. id at280. 68. !d. at 281. 69. !d. 70. !d. 71. !d. at 276. 72. see, e.g., sharvelle v. magnante, 836 n.e.2d 432 (ind. ct. app. 2005); duneland emergency physician's med. group v. brunk, 723 n.e.2d 963 (ind. ct. app. 2000); norlund v. faust,675n.e.2d l142(ind. ct.app.1997); gomezv.chuamed.corp.,slon.e.2d 191 (ind. ct. app. 1987). 73. see sharvelle, 836 n.e.2d at437-39 (declining to enforce a covenant prohibiting the practice of"health care of every nature and kind" where the physician-employee was hired only to perform ophthalmological services); duneland, 723 n.e.2d 963 (holding the covenant unen­ forceable because the clinic suffered no injury other than the typical expenses incurred when a departing employee must be replaced); norlund, 615 n.e.2d at 1155 (refusing to enforce the portion of the covenant restraining the practice of optometry as long as the physician-employee did not contact optometrists on the referral list for which the physician-employee was specifical­ ly hired to develop); fumo v. med. group ofmichigan city, inc., 590 n.e.2d 1103, 1108 (ind. ct. app. 1992) (dissolving a preliminary injunction because the trial court's findings failed to address the injunction's effects on the public). 74. gomezv. chuamed. corp.,510n.e.2d 191, 197-198(ind. ct.app.l987)(sullivan, j., concurring. in which garrard, j., as a second member of the three-judge panel, also joined). 2009] physician employee non-compete agreements 265 raymundo in its 1997 decision innorlundv. faust.15 in norlund, an o~hthalmologist hired an optometrist to develop a list of referring optometrists. 6 their employment agreement specifically required the employee-optometrist to educate other optometrists about the employer's oph­ thalmological services.77 the agreement contained a restrictive covenant that not only prohibited the employee-optometrist from post-employment contact with any person on the developed referral list, but also prohibited the employee­ optometrist from practicing optometry with any ophthalmologist in the listed counties.78 the indiana court of appeals viewed raymundo as holding ''that the pub­ lic's general interest in medical services is subservient to the public interest in the freedom of individuals to contract. ,.79 constrained by raymundo, the nor­ lund court reluctantly held that the non-compete agreement restricting the prac­ tice of medicine was not void as a matter oflaw.80 the court determined, however, that the portion of the covenant restraining dr. norlund from ''per­ forming any services as ao ... medical optometrist" was nonetheless void. 81 it held that while the employer had an interest in protecting its goodwill, the re­ striction on the practice of medicine served no purpose other than to "prevent [dr.] norlund from practicing his livelihood. • .sa the court noted, however, that its disagreement with raymundo was easier to overcome here because dr. nor­ lund was prohibited only from contacting referring optometrists and acting as a salesman-not from providing optometry services. 83 most recently, the indiana supreme court considered a physician non­ compete agreement in central indiana podiatry, p. c. v. krueger. 84 in krueg­ er, the employee-physician was subject to a two-year restrictive covenant that included fourteen enumerated counties, plus any county in which the employer maintained an office, and any contiguous counties. 85 unlike previous cases in which the employee voluntarily resigned, 86 the clinic dismissed dr. krueger 75. 675n.e.2d ll42(ind. ct.app.l997). twointerveningcasesofthelndianacourtof appeals, fumo v. med. group of michigan city, inc., 590 n.e.2d 1103 (ind. ct. app. 1992) and med. specialists, inc. v. sleweon, 652 n.e.2d 517 (ind. ct. app. 1995), had applied ray­ mundo 's standards, each with opposite results. 76. norlund, 615 n.e.2d at 1146. 77. /d. 78. id. at 1146-47. 79. id at 1153. the majority opinion was authored by judge sullivan, who also wrote the concurring opinion in gomez, urging the indiana supreme court to reexamine its position with respect to the public policy implications of covenants restricting the practice of medicine. while judge sullivan's concurring opinion was joined by judge garrard in gomez, judge sullivan won over another colleague in that judge kirsch also joined his majority opinion in norlund. 80. norlund, 615 n.e.2d at 1153-54. 81. id. at 1159. 82. ld. at 1155. 83. jd. at 1154. 84. cent. ind. podiatry, p.c. v. krueger, 882 n.e.2d 723 (ind. 2008). 85. id at 726. 86. see, e.g., raymundo v. hammond clinic ass'n, 449 n.e.2d 276 (ind. 1983). 266 indiana heal'ih law review [vol. 6:253 because of multiple incidents of inappropriate conduct with female staff.87 fol­ lowing his termination, dr. krueger negotiated employment with one of the clinic's competitors, took the clinic's patient list, and then sent letters to those patients informing them ofhis change in employment.88 the clinic sued for a preli.miruuy injunction to enjoin dr. krueger's activi­ ties, but the trial court denied it, finding that enforcement would disserve the public interest. 89 on appeal, the indiana court of appeals reversed, applying the traditional test as required by raymundo. 90 rather than evaluating the co­ venant's impact on the public interest, the court of appeals simply recited ray­ mundo's statement that ''the public interest in the freedom of individuals to contract" is "paramount.'81 the indiana supreme court, however, affirmed in part the trial court's denial of the injunction, finding that the restrictive covenant was unenforceable, except in a limited geographic area.92 unlike raymundo, which summarily dismissed the physician's public policy arguments as "self-serving,"93 the krueger court admirably included a more thorough discussion of the public policy effects of physician non-compete agreements.94 while it explicitly re­ jected a per se rule of invalidity,95 the standard it applied is not entirely clear. on the one hand, the court indicated that it would continue to apply raymun­ do's "reasonableness" standard, 96 which gives no special consideration to phy­ sician non-competes.97 on the other hand, the krueger court stated that "[non­ compete] agreements by physicians should be given particularly careful scruti­ ny."98 the problem with the decision in raymundo, as well as the decisions that followed in its steps, is the oversimplification of the complex ''public interest" question. the public has more at stake than merely an "interest in the freedom of individuals to contract. "99 the krueger court appears to acknowledge that physician non-compete agreements are deserving of more careful judicial scru87. krueger, 882 n.e.2d at 726; see also cent. ind. podiatry, p.c. v. krueger, 859 n.e. 2d 686, 689 (ind. ct. app. 2007), vacated, 882 n.e.2d 723 (ind. 2008). 88. krueger, 882 n.e.2d at 726. 89. id.; krueger, 859 n.e.2d 686, 691. .90. krueger, 859 n.e.2d 686, 692-696. 91. id at 696. 92. krueger, 882 n.e.2d at 734. 93. raymundo v. hammond clinic ass'n, 449 n.e.2d 276, 281 (ind. 1983). 94. krueger, 882 n.e.2d at 727-28. 95. /d. at 728. 96. id the krueger court noted that "raymundo has been on the books for over twenty years" and indicated agreement with the supreme court oflllinois in mohanty v. st. john heart clinic, s.c., 866 n.e.2d 85 (ill. 2006), which held that it would not "deviat[ e] from [illinois '1 longstanding practice of finding reasonable restrictive covenants in medical employment con­ tracts enforceable .... " id (quoting mohanty v. st. john heart clinic, s.c., 866 n.e.2d 85, 95 (ill. 2006). 97. see supra text accompanying notes 58-70. 98. krueger, 882 n.e.2d at 729. 99. raymundo v. hammond clinic ass'n, 449 n.e.2d 276, 280 (ind. 1983). 2009] physician employee non-compete agreements 267 tiny than non-compete agreements in the general commercial context, 100 but failed to clarify the applicable standard for a heightened scrutiny. the next part proposes a framework for a more demanding review of physician restrictive covenants that will give greater weight to the public's interests and yet take into account the employer's interests in realizing a return on its investment in its employees. iv. analysis: proposal for a more demanding review of physician restrictive covenants because physician restrictive covenants implicate broader public interests than do general commercial restrictive covenants, such covenants should be reviewed under a more demanding level of scrutiny. the question remains, however, what factors--other than economic concerns-should indiana law take into consideration in determining the reasonableness of the physician re­ strictive covenant? this part examines several avenues that could be taken, at various steps in the traditional analysis, to achieve a more demanding review of physician non-compete agreements. a. determine the genuinely legitimate, protectable interests of medical practice groups some courts have been fairly generous to physician-employers by broadly construing the scope of the employer's legitimate protectable interests. for ex­ ample, in medical specialists, inc. v. sleweon, the indiana court of appeals held that the continued success of the employer's practice was a legitimate pro­ tectable interest: "clearly, the continued success of the practice, which is de­ pendent upon patient referrals, is a legitimate interest worthy of protection. "1 01 it is difficult to imagine any action taken by the employer that would not serve the goal of"continued success of the business." a more stringent review of physician covenants can be accomplished by narrowing the scope oflegitimate protectable interests of physician employers. this narrowing is exemplified by the view that the employer's only legitimate interest is to prevent the employee from unlawfully using some advantage at the employer's expense that is not generally available to the public, i.e., trade se­ crets.102 while some courts have held that an employer's list of patients is a legitimate protectable interest ifkept confidential, 103 other courts have held that 100. krueger, 882 n.e.2d at 729. 101. med. specialists; inc. v. sleweon, 652 n.e.2d 517, 523 (ind. ct. app. 1995). the sleweon court relied on the fact that dr. sleweon had no ties to indiana before he was recruited by his employer and thus enriched his patient base at the expense of his employer. 102. norlund v. faust, 675 n.e.2d ll42, 1154 (ind. ct. app. 1997) (citing jenkins v. king, 65 n.e.2d 121 (ind. 1946). 103. duneland emergency physician's med. group v. brunk, 723 n.e.2d 963, 966 (ind. ct. app. 2000) (quoting donahue v. permacel tape corp., 127 n.e.2d 235, 240 (ind. 1955)). 268 indiana health law review [vol. 6:253 customer lists are not a legitimate interest if the information contained in the lists has not been kept confidential and is readily available to the public .104 at least one indiana case applied this prong more firmly. in dune/and emergency physician's medical group v. bronk, 105 although the medical group's physicians provided services to many individual patients, they treated all of those patients at the same hospital under a contract between the hospital and the medical group. under the contract, the hospital paid the medical group for its services and then billed the patients directly. 106 pursuant to this ar­ rangement, the court determined that the individual patients were the hospital's customers-not the medical group's.107 rather, the court found that the medi­ cal group's only customer was the hospital itself.108 when the medical group's employee left to work for another hospital, the medical group sought to enforce its restrictive covenant.109 the court held that because the medical group ser­ viced only one hospital, its customer base was not threatened by the employee's move to another hospital, which serviced entirely different patients.110 the court astutely recognized that the medical group could show no harm "other than the typical expenses incurred when a departing employee has to be re­ placed. "111 thus, as in dune/and, one way to engage in a more demanding re­ view of physician restrictive covenants is to firmly require the employer to demonstrate a protectable interest. if the employer's only harm is the typical expenses associated with replacing a departing employee, the employer has failed to carry its burden of proving a legitimate protectable interest. b. full consideration of public interests affected by physician non-competes courts should consider public interests other than economic concerns when determining the reasonableness of physician restrictive covenants. while the various public interests are discussed in more detail below, a preliminary observation is in order. although the employer bears the burden of proving the reasonableness of a restrictive covenant, 112 under the traditional formulation of the rule, this factor is stated in the negative. thus, the employer must prove the negative by showing that enforcement of the non-compete provision will not harm the public interest. because proving the negative is a difficult task, the burden of showing some harm to the public interest, as a practical matter, really 104. am. shippers supply co. v. campbell,456n.e.2d 1040, 1044 (ind. ct. app.1983). 105. dune/and, 723 n.e.2d at 963. · 106. id. at 966. 107. id. 108. ld. 109. id at 965. llo. ld. at 966-67. ill. dune/and, 723 n.e.2d at967. 112. see, e.g., valley med. specialists v. farber, 982 p.2d 1277, 1286 (ariz. 1999) (party seeking to enforce the restrictive covenant bears the burden of persuasion). 2009] physician employee non-compete agreements 269 falls on the physician employee. litigants should be aware of this apparent re­ versal of the burden allocations. 113 courts may be limited in their decision­ making if the physician-employee fails to bring the full scope of the bann done to the public interests to the court's attention. 1. public interests favoring enforcement while many public policy considerations weigh against enforcement, there are also some public policy implications favoring enforcement. first, some authorities have expressed the view that because medical boards-not courts--are charged with regulating physician conduct, courts should defer to those medical boards.114 for example, in karlin v. weinberg, the court ac­ knowledged that the ama 's current code of ethics, while strongly discouraging non-compete agreements, does not expressly prohibit them outright.115 in indi­ ana, physicians are regulated and disciplined by the medical licensing board of indiana, 116 which bas promulgated its own standards of practice.117 these standards, however, do not prohibit physicians from entering into non-compete agreements.118 in most cases, this demonstration of judicial restraint would be laudable. indeed, the legislative branch-not the judicial branch-is responsible for set­ ting the policy goals of the law.119 in the context of non-compete agreements, however, the traditional formulation of the common law rule charges the judi­ ciary with determining whether enforcement of a particular restrictive covenant will harm the public good.120 courts are duty-bound to make this determina­ tion, notwithstanding their reluctance to formulate public policy. if the legisla­ ture is concerned about courts usurping its power under the common law rule, it certainly bas the power to change the rule or to make its own policy statement. in fact, a number of state legislatures have responded by affirming, modifying, or superseding judicial decisions that weigh the respective interests implicated by physician restrictive covenants. these states include: colorado, 121 dela­ ware, 122 massachusetts, 123 and tennessee.124 presently, the indiana general 113. for a discussion of imposing a heightened burden of proof on the employer, see infra partiv.e. 114. see, e.g., intermountain eye and laser ctrs. v. miller, 127 p.3d 121, 132 (idaho 2005). 115. karlin v. weinberg, 390 a.2d 1161, 1168 n.6 (n.j. 1978). 116. ind. code§ 25-22.5-2-1 (west 2008). 117. see generally 844 ind. admin. code 5-2-1 to -22 (2008). 118. /d. 119. see, e.g., fla. dept. of revenue v. piccadilly cafeterias, inc., 128 s.ct. 2326, 2339 (2008); kaser v. barker, 811 n.e.2d 930, 932-33 (ind. ct. app. 2004). 120. see supra part ii.b. 121. colo. rev. stat. ann.§ 8-2-113(3) (enacted in 2003). 122. del. code ann. tit. 6, § 2707 (enacted in 1993). 123. mass.gen.lawsann. cb. 112, § 12x(enacted in 1991). 124. tenn. code ann. § 63-1-148 (enacted in 2007). iowa also attempted to do so in 270 indiana heal1h law review [vol. 6:253 assembly has not enacted a physician non-compete policy, and indiana courts should therefore be willing to make those policy judgments without fear of overstepping their bounds. 125 second, the public has an important interest in protecting the freedom of contract.126 the sanctity of contract should be inviolate where a party freely binds himself to his own detriment. but what if the contract adversely affects important interests of persons who were not party to the contract and were in no position to become a party to the contract? arguably, the sanctity of contract should be relaxed where the rights of third persons, and particularly the public, are adversely affected. as discussed elsewhere in this note, 127 the right of a patient to choose his or her treating physician is adversely affected by physician restrictive covenants. the traditional formulation of the rule already takes into consideration the sanctity of contract by balancing it against other harms to the public interest.128 if the freedom of contract always prevails, there is no point in considering any harm to the public's interest. thus, a rote adherence to the freedom and sanctity of contract is redundant, neglects public interest, and should be avoided. third, allowing restrictive covenants may encourage investment in the de­ velopment of younger physicians. as in many industries, it often takes several years for employers to recoup their initial investment in employee hiring and training. employers may be reluctant to make the capital investment required to hire and train a young employee, only to have the employee leave and com­ pete against the employer before the employer can even recoup its capital out­ lay. arguably, without restrictive covenants to protect against this risk, employers of physicians may be less willing to invest in young physicians, the­ reby making the services of physicians less available to the public. restrictive covenants, however, are not the only means available to pro­ tect against this problem. one common feature among physician employment agreements containing restrictive covenants are buyout provisions or liquidated damages clauses that allow the employee to engage in a prohibited activity after termination of employment by paying a predetermined amount to the employ1991, but the governor vetoed the legislature's efforts, stating that the reasonableness standard applied by iowa courts adequately balanced the competing interests involved. s. file 210, 74th gen. assem. (iowa 1991 ); veto letter from the hon. terry e. branstad, governor oflowa, to the hon. elaine baxter, iowa secretary of state (june 5, 1991), available at http://contentdm.legis.state.ia.us/cdm4/document.php?cisoroot=n4bills&cisoptr=l44 40&rec=l. 125. for an example of judicial reluctance to entertain any public policy arguments in this area, see regional urology, l.l. c. v. price, 966 so.2d 1087, i 095 (la. ct. app. 2007) (''the policy concerns raised by dr. price are ... a matter for the legislature to address."). see also mohanty v. st. john heart clinic, s.c., 866 n.e.2d 85, 95 (ill. 2006). 126. robert's hair designers, inc. v. pearson, 780 n.e.2d 858, 869 (lnd app. 2002)("jn. diana courts have long recognized and respected the freedom to contract." (quoting eck & as­ socs., inc. v. alusuisse flexible packaging, inc., 700n.e.2d 1163, 1167 (ind. ct. app. 1998)). 127. see discussion of patient rights infra pp. 41-43. 128. see supra part ll.b. 2009] physician employee non-compete agreements 271 er.129 this mitigating feature not only protects the employer's investment in new employees but also gives the employee the option to compete against the employer for a price. these buyout options can be tailored to the employer's interests by decreasing the buyout amount according to the length of time that the employee stays with the employer, correlating to the employer's anticipated losses should the employee leave before the employer can realize a profit on its investment. for example, a buyout provision might require the employee to pay the employer $200,000 if the employee leaves during the first year, $150,000 during the second year, $100,000 during the third year, and so on. although a buyout option can also be misused, such as setting the fee exorbi­ tantly high or for an undue length of time, its proper use better balances the public's interest in the availability of medical services because it creates more options. with a buyout provision, the physician-employee has the option to restrict her practice or pay the buyout fee, the purpose of which should be to reimburse the employer its capital investment costs. if patient demand for the departing physician-employee is sufficiently high (indicating a physician short­ age under free market economic principles), the departing physician-employee should be able to command a price that justifies paying the buyout fee. by con­ trast, an injunction provides only one option: restricting the availability of the physician-employee's services, regardless of the public's need for such servic­ es. thus, while there is a public interest in encouraging employers to invest in younger physicians, this goal can be better accomplished if the restrictive cove­ nants are accompanied by a reasonably tailored buyout provision. finally, restrictive covenants may help disperse and decentralize physi­ cians by encouraging them to move to rural or medically underserved areas, depending on the facts of the case. assume, for example, a physician, who lives in a suburban area, works in a metropolitan area under a contract with a restrictive covenant. when the employment relationship terminates, the physi­ cian might be more willing to commute to outlying rural communities outside the covenant's geographic scope, rather than move to another major metropoli­ tan area. these rural areas often are in need of good doctors. 130 the problem here is the existence of too many unpredictable variables, such as the geograph­ ic scope of the covenant and the physician's post-termination plans, to consis­ tently achieve the goal of dispersing physician services. courts should nonetheless consider this possibility, if the right facts present themselves. 2. public interests disfavoring enforcement until krueger, indiana courts, and particularly the indiana supreme court in raymundo, have overlooked important public interests affected by physician 129. see e.g., raymundo v. hammond clinic ass'n, 449 n.e.2d 276 (ind. 1983). 130. comm. on furore of ruraliieal1h care, bd. on iieal1h care servs., quaijty 1hrough collaboration: the furore of rural iiealm care 220 (the nat'l acads. press 2005). 272 indiana health law review [vol. 6:253 restrictive covenants that should be factored into the traditional test. these var­ ious interests are discussed at length below. a. medical ethics discourage the use of physician restrictive covenants in all contexts and outright prohibit them in limited contexts (i) the national position: the american medical association while not dispositive, one public policy consideration is the position of the ama. 131 the current position of the ama discourages the use of physician restrictive covenants in all contexts. 132 moreover, where a restrictive covenant is excessive in scope or duration or "fail[ s] to make reasonable accommodation of patients' choice of physician," the ama' s current standards go beyond "dis­ couraging" such covenants and condemn them outright as unethical.133 indeed, a review of the development and evolution of the ama' s position reveals a trend towards stronger ethical prohibitions on restrictive covenants.134 since its founding in 1847, the ama has written and published its code of medical ethics governing the conduct ofphysicians.m the 1847 version of the ama code of medical ethics did not address the ethical propriety of re­ strictive covenants.136 it did, however, contain ethics statements encouraging doctors to view their healing arts as a professional service to the public rather than a business.137 several other provisions recognized the importance of main131. the ama's membership consists of approximately thirty percent (or 300,000) of all u.s. physicians. am.med.ass'n,f'requenlly askedquestionsinenncs,http://www.ama­ assn.org/ama/pub/physician-resources/medical-ethics/ama-code-medical-ethics/ftequently­ asked-questions.shtml (follow "what can the ama do about a physician i believe is behaving unethically or unprofessionally?") (last visited mar. 7, 2009). as a voluntary organization, the ama does not have power to revoke or suspend physicians'licenses; rather, that function be­ longs to each state's licensing boards. /d. the ama's bylaws, however, allow it to take discip­ linary action against member physicians with respect to their membership in the organization for unethical conduct. /d. 132. am. med. ass'n, code of medical ennes § e-9.02 (2009), available at http://www.ama-assn.org/amal/publupload/mm/code _ o(_ med_eth/toc.html. 133. /d. 134. the prior ama position (from 1960 to 1980) was more lenient. it focused on the freedom of contract, allowing for a "reasonable agreement not to practice within a certain area for a certain time, if it is knowingly made and understood ... murfreesboro med. clinic, p .a. v. udom, 166 s. w.3d 674, 679 (tenn. 2005) (quoting ama, principles of medical ethics, opi­ nions, and reports of the judicial council25 (1960)). 135. am. med. ass'n, ennes timeline: 1847-1940, http://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/ama-code-medical-ethics/about-ama-code-medical-ethics/ history-ama-ethics/ethics-timeline-1847-1940.shtml (last visited mar. 7, 2009) 136. am. med. ass'n, code of medical ennes (1847), available at http://www.ama­ assn.org/ama/upload/mm/369/184 7code.pdf. 137. see, e.g., id at ch. ll, art. i. § 4 (condemning "secret nostrums" and patents for surgic­ al devices and medicines as being "inconsistent with beneficence and professional liberality") and id at cb. ii, art. i, § 3 (declaring as "derogatory to the dignity of the profession" soliciting individuals with particular diseases via public advertisements and handbills). 2009] physician employee non-compete agreements 273 taining an ongoing physician-patient relationship. 138 the next significant change to the ama code of medical ethics relating to restrictive covenants occurred in 1922,139 when the judicial council com­ pletely prohibited physicians from soliciting patients. 140 this policy remained in effect untill980. 141 although the ama code during this period did not ex­ pressly address covenants restricting a physician's right to practice medicine, the direct prohibition on advertising and solicitation of patients would have ob­ viated the need for nonsolicitation provisions that are seen in many of today' s physician employment agreements.142 moreover, the other relevant provisions from the 184 7 code of medical ethics remained in effect. in 1957, the ama restructured its collection of ethics statements and opi­ nions. until then, the ama' s ethics statements had consisted primarily of its code of medical ethics contained in forty-seven code sections.143 in 1957, however, drawing upon the existing code of medical ethics and opinions of the judicial council, the ama distilled the existing code into ten abstract prin­ ciples ofmedical ethics.144 as a result of this change, the ama code ofeth138. see, e.g., id. at ch. ii, art. v, § 6 (establishing, as a matter of ethics, a preference for a family's regular physician during an emergency) and id. at ch. ii, art. v, § 7 (enjoining tempo­ rary physicians to relinquish a patient to the care of the patient's regularly treating physician, with the patient's consent, as soon as possible). 139. although the code was amended in 1903, only "[m]inor changes were made to the 1847 code and the title was changed to the principles of medical ethics." am. med. ass'n, timeunes of ama history: 1900-1920, http://www.ama-assn.orglamalpub/about-ama/our­ history/timelines-ama-history/1900-1920.shtml (last visited mar. 7, 2009). 140. the ama established the judicial council in 1873 to address ethical and constitu­ tional controversies within the organization. am. med. ass'n, timelinesof amahistory: 184 7-1899, http://www.ama-assn.orglamalpub/about-amalour-history/timelines-ama­ history/i 84 7-1899 .shtml (last visited mar. 7, 2009). the ama changed the name of the judi­ cial council to the council on ethical and judicial affairs ("ceja") in 1985. am. med. ass'n, timelines of ama history: the 1980s, http://www.ama-assn.org/ama/pub/about~amalour­ history/timelines-ama-history/the-1980s.shtml (last visited mar. 7, 2009). the ceja continues to serve as the internal body of the ama that interprets its constitution, bylaws, rules, and ethi­ cal principles and that decides individual ethical violations by member physicians. bylaws of the am. med ass'n § 6.52 (2008), available at http://www.ama-assn.orglamallpub/upload /mm/409/bylaws.pdf. 141. am. med. ass'n, 'timelines of ama history: 1921-1940, http://www.ama­ assn.org/ama/pub/about-ama/our-history/timelines-ama-history/1921-1940.shtml (last visited mar. 7, 2009). 142. am. med. ass 'n code of medical ennes ( 184 7), supra note 136, at ch. ii, art. i, § 3 ("it is derogatory to the dignity of the profession, to resort to public advertisements or private cards or handbills .... "). 143. am. med. ass'n, principles of medical ennes (1957), available at http://www.ama-assn.orglama/upload/mm/369/1957principles.pdf. 144. !d. in 1957, the judicial council moved the principles away from addressing specific conduct towards making more abstract statements of ethical standards. id the 1957 principles were based on (1) the 1955 edition of the principles ofmedical ethics and (2) "[a]bstracts of interpretations of ethical principles made by the judicial council since 1900." !d. the 1955 principles "consisted of a preamble and forty-seven sections" compared to the 1957 principles' preamble and ten sections. !d. the practical effect of broadening the language of the principles was to "g[ijve the judicial council broad rule making authority, allowing them [sic] to issue ethical pronouncements without securing house of delegates approval." am. med. ass'n, 274 indiana heal til law review [vol. 6:253 ics now consists of the principles ofmedical ethics and a codified compilation of the current opinions of the council on ethical and judicial affairs ("ceja").145 although the ceja did not issue any fonnal opinions on physi­ cian restrictive covenants at that time, two principles from the 1957 principles of medical ethics are potentially relevant to restrictive covenants. first, the 1957 principles of medical ethics provided that "[a] physician may choose whom he will serve."146 while this principle was likely aimed at a growing concern among physicians that they should not be forced to accept patients, it also arguably addresses the ability of a physician to choose his own patients, even those of a former employer. secon~ consistent with the change that oc­ curred in 1922, the 1957 principles ofmedical ethics provided that a physician "should not solicit patients."147 in 1980, the principles ofmedical ethics were again amended to repeal the absolute prohibition on solicitation of patients.148 moreover, two additional principles adopted that year are relevant to physician restrictive covenants. 149 first, the 1980 principles of medical ethics provided that "[a] physician shall respect the rights of patients ... and shall safeguard patient confidences within the constraints of the law."150 secon~ the 1980 principles of medical ethics provided that "[a] physician shall recognize a responsibility to participate in activities contributing to an improved community."lsl relying on these two principles, the ceja eventually opined that restrictimellnesof amahistory: 1941-1960, http:llwww.ama-assn.org/amalpub/about-ama/our­ history/timelines-ama-bistory/1941-1960.sbtml (last visited mar. 7, 2009). largely as a result of this change, the ama code of ethics now bas two components: (1) the principles ofmedical ethics which establish broad principles for governing the conduct of physicians, and (2) the current opinions of the ceja, which constitute ceja's application of the principles to more tbim. 200 specific ethical situations in the medical profession. am. med. ass'n, developing ama poucms, http://www.ama-assn.org/ama/pub/about-amalour-peoplelhouse-delegates/ developing-ama-policies.shtml (last visited mar. 7, 2009). the end of each ceja opinion in­ cludes a roman numeral reference to the principle(s) upon which the council relied in formulat­ ing its opinion. /d. ''the following principles adopted by the american medical association are not laws, but standards of conduct that define the essentials of honorable behavior for the physician." am. med. ass'n, plunciples of medical ennes (1980), available at http://www.ama-assn.org/ama1/publupload/mm1369/1980 _principles.pdf. 145. am. men. ass'n, developing ama poucms, http://www.ama-assn.org/ama/pub/ about-ama/our-peoplelhouse-delegatesldeveloping-ama-policies.shtml (last visited mar. 7, 2009). 146. am. men. ass'n, principlesofmedicalenncs(1957), supra note 143, § 5. 147. /d. 148. am. med. ass'n, principles of medical ennes (1980), supra note 144. the 2001 principles ofmedical ethics left sections iv, vi, and vii of the 1980 principles substantively unchanged. compaream.med.ass'n,princjplesofmedicalenncs(l957),supranote 143, with am. men. ass'n, prjnciples of medical ennes (2001). available at http://www.ama­ assn.org/ama/pub/physician-resourcesfmedical-ethics/ama-code-medical-etbics/principles­ medical-ethics.shtml. 149. the 1980 principles ofmedical ethics also left unchanged the principle that a physi­ cian shall ''be ftee to choose whom to serve .... " am. med. ass'n, principles of medical ennes (1980), supra note 144, §vi. 150. /d. §iv. 151. /d. §vii. 2009] physician employee non-compete agreements 275 tive covenants should be discouraged. 152 the current ceja opinion was estab­ lished in 1998, which now discourages the use of any physician restrictive venant: covenants-not-to-compete restrict competition, disrupt continuity of care, and potentially deprive the public of medical services. the council on ethical and judicial affairs discourages any agreement which restricts the right of a physician to pmctice medicine for a specified period of time or in a specified area upon termination of an employment, partnership, or corpomte agreement. restrictive covenants are unethical if they are excessive in geographic scope or duration in the circumstances presented, or if they fail to make reasonable accommo­ dation of patients' choice of physician. (vi, vii) issued prior to april 1977; updated june 1994 and june 1998. 153 in 2006, ceja recommended substantive changes to its opinion.154 re­ cognizing that the ama code of medical ethics "generally promotes patient choice,"155 ceja recommended language that would encourage physicians­ both employerand employee-physicians-to be more accommodating of pa­ tient choice when entering into restrictive covenants. 156 when ceja presented its recommendations to the ama house of delegates, however, the proposed amendments were met with "much resistance."157 the ama house of dele­ gates referred the report back to ceja, which withdrew the report in 2007 after "input from interested constituencies, including representatives from the advi­ sory committee on group practice physicians. " 158 this recent series of events indicates that the debate over physician restrictive covenants is far from settled and demonstrates a shift towards disfavoring them altogether. in addition to ceja' s express opinion on restrictive covenants, other ceja ethical statements affect restrictive covenants. for example, physicians 152. am. med. ass'n, code of medical ennes (2009), supra note 132, § e-9.02. 153. id. 154. am. med. ass'n council on etidcaland judicialaff. rep. no. 5-a-06 at 2:17-20 (withdrawn june 2007 by rep. no. 8-a-07). 155. id. at 1:27. 156. see, e.g., id. at 2:43-45 (''upon entering into a contractual relationship, both parties should establish equitable tenns of severance to promote the welfare of patients, in part by faci­ litating patient choice of physicians.") 157. am. med. ass'ncouncilonenncalandjumcialaff. rep. no. 8-a-07 at 1:10, available at http://www.arna-assn.org/amal /pub/upload/mm/369/ceja _ 8a07 .pdf. 158. !d. at 1: 13-14. citing the confidentiality of internal deliberations, ceja has declined to reveal the nature of the concerns raised by the advisory committee on group practice physi­ cians. e-mails from lee black, senior research associate, ama ethics group, to author (oct. 22,2007, 13:47est; oct. 31,2007, 14:59 est)(onfilewiththelndianahealthlawreview). 276 indiana health law review [vol. 6:253 are under an ethical duty to put patients' interests above their own self-interest (e.g., avoiding a buyout provision or liquidated damages clause) and above ob­ ligations to other groups (e.g., their practice groups). 159 also, although physi­ cians are free to turn down a prospective patient, 160 once the physician-patient relationship is established, physicians may not withdraw from that relationship until they have given sufficient advance notice to allow the patient to secure another physician. 161 whether the ama as an organization will take an even stronger ethical stance against physician restrictive covenants remains to be seen. but recent events reflect an undeniable clash between medical ethicists, who are advocat­ ing further limitations on the use of restrictive covenants, and practice groups, who are concerned about the business and financial interests of employers. the larger historical picture, however, reflects a trend towards a stronger position disfavoring physician restrictive covenants as unethical. (ii) medical ethics in indiana while the views of the national medical community should be considered, even more importantly, indiana courts should first consider the views of the indiana medical community on the issue. it was, after all, the indiana delega­ tion to the ama house ofdelegates that "introduced a resolution that unequi­ vocally declared that restrictive covenants were unethical. "162 if the indiana medical community opposes covenants not to compete as being unethical for physicians, then indiana law arguably should reflect the industry's sense of public policy. indiana physicians are governed by the medical licensing board oflndiana.163 while the board's regulations do not expressly prohibit restric­ tive covenants, they do require respect for patients' rights164 and for avoiding disruption in patient care.165 b. the patient's right to choose a physician perhaps the most overlooked public concern so far in indiana courts has been the interests of patients that are affected by restrictive covenants, especial159. am. med. ass'n, code of medical ennes (2009), supra note 132, § e-1 0.015. 160. id § e-9.06. 161. id. § e-8.115. 162. berg, supra note 32, at 7. 163. ind. code§ 25-22.5-2-7 (2008). 164. 844 ind. admin. code 5-2-4 (2007) (providing that physicians may not withdraw from providing care until they have given sufficient advance notice in advance to allow the pa­ tient to secure another physician). 165. 8441nd. admin. code 5-2-l6(b) (2007)(providingthata physician who retires from practice, discontinues a practice, or moves away from the community must notify all of his or her active patients in writing that the practice is being discontinued and that the patient should seek another physician). although beyond the scope of this note, it is interesting to consider the possible conflict between this ethical regulation and a non-solicitation agreement. 2009] physician employee non-compete agreements 277 ly insofar as a restrictive covenant impinges on the patient's ability to select the physician of his choosing or to ensure continuity of care for long-term diseases. here again, the ama's code of medical ethics is instructive and recognizes the right of patients to freely choose their physicians: "free choice of physi­ cians is the right of every individual."166 courts should be even more vigilant to protect patient interests because these patients, many of whom may be more intimately affected in matters oflife and death by the non-compete agreements than either the physician-employee or the employer, are not represented in the bargaining of the physician employ­ ment agreement. moreover, most patients are not aware of the existence of such agreements and have no way of "shopping" for physicians that are not bound to restrictive covenants. as a matter of priority, it has been shown that patients would rather have the right to choose their individual physicians than to choose a particular health insurance plan.167 there is also a correlation between patients' choice of doc­ tors and patients' satisfaction in their medical care. according to one study, patients ''who had a limited choice of where to go for care were more dissatis­ fied than those with few plan choices. "168 this freedom of choice is so impor­ tant to patients that they are willing to pay more out of their own pockets for health insurance if doing so means they can have an unrestricted choice of phy­ sicians. 169 patients have greater confidence in the physicians that they them­ selves have chosen.170 finally, the ability of patients to freely choose their physician increases the quality of health care on the whole. first, one byproduct of increased pa­ tient confidence is a greater likelihood that patients will seek timely and appro­ priate care from their physician of choice.171 second, the freedom of choice facilitates patients' ability to preserve continuity of care in cases where it is im­ portant to them, such as prenatal care or chronic illnesses.172 patients them­ selves indicate that the most important reason for having a choice in physicians is the ability to control the quality oftheir care.173 while restrictive covenants hinder a patient's ability to select a physician, the use ofliquidated damages clauses and narrow geographical limitations may adequately accommodate a patient's right to choose his physician.174 if the 166. am. med. ass'n, code of medical ennes (2009), supra note 132, § e-9.06. 167. jeannem. lambrew, "choice" in health core: what do people really want?,issue brief, (the commonwealth'fund, new york. n.y.), sept. 2005, at 3, available at http://www.commonwealthfund.org/usr_docllambrew_853_choice_ib.pdflsection=4039. 168. id. 169. u.s. advisory comm'n on consumer prot. and quality in the healm care indus.,qualityfirst:betierhealmcareforailameiucansapp.a,ch.2(1998),availa­ ble at http:l/www.hcqualitycommission.gov/final. 170. id 171. ld. 172. ld. 173. ld. 174. st. clair med., p.c. v. borgiel, 715 n.w.2d 914, 921 (mich. ct. app. 2006) (per 278 indiana health law review [vol. 6:253 physician pays liquidated damages, he or she is allowed to practice in the re­ stricted area, and any current patient's rights are adequately protected. similar­ ly, if the geographic limitation is sufficiently narrow, for example a restriction covering a seven-mile-radius, 175 the departing physician's current patients would be able to continue their treatment without undue travel burdens. the less distance the patient is required to travel to maintain continuity of treatment, the less of a burden the restrictive covenant places on the patient's right to choose. thus, courts should consider the scope of a restrictive covenant's geo­ graphic limitation in light of the burden it places on a patient's right to seek continuing care, as well as other conditions that may affect the patient's right to choose. c. physician shortages in indiana another relevant public interest consideration is whether the particular re­ stricted geographic area suffers from a physician shortage. if the restricted area already has a physician shortage, enforcing the non-compete agreement will only exacerbate the problem. this problem is particularly acute in indiana, where nearly half of indiana's counties176 contain areas that have been desig­ nated by u.s. health and human services as a "health professional shortage area" in "primary medical care. " 1 77 moreover, more than sixty percent of in­ diana counties178 contain areas that have been designated by u.s. health and human services as a "medically underserved area." 179 taking those statistics together, more than two thirds of indiana's ninety-two counties contain areas that have been designated by u.s. health and human services as either a curiam) ("moreover, patients' choice of physician is protected by the modest geographical scope of the covenant [seven-mile radius] and the liquidated damages clause"). 175. jd. (holding that a seven-mile-radius restriction would not interfere with the patient's right to choose a physician). 176. health professional shortage areas, supra note 33. forty-five oflndiana's nine­ ty-two counties contain areas that have been designated as "health professional shortage" areas: allen, clark, clay, crawford, daviess, delaware, elkhart, fountain, grant, greene, hendricks, henry, howard, jasper, jennings, johnson, la porte, lagrange, lake, madison, marion, martin, miami, newton, owen, parke, peny, porter, pulaski, putnam, randolph, rush, scott, spencer, st. joseph, starke, sullivan, switzerland, tippecanoe, vanderburgh, vermillion, vigo, warren, wayne, and white counties. id. 177. for the criteria used by the u.s. department of health and human services to desig­ nate an area having a shortage of primary medical care professionals, see 42 c.f .r. pt. 5, app. a (2008). 178. medicail y underserved areas, supra note 33. fifty-six of indiana's ninety-two counties contain areas designated as "medically underserved": allen, brown, carroll, cass, clark, clay, clinton, crawford, daviess, decatur, delaware, elkhart, fayette, floyd, franklin, gibson, grant, greene, howard, huntington, jackson, jefferson, jennings, johnson, knox, lake, laporte, madison, marion, martin, miami, monroe, newton, ohio, orange, owen, parke, perry, pike, porter, posey, ripley, st. joseph, scott, spencer, starke, sullivan, switzerland, tippecanoe, union, v anderburgh, vermillion, vigo, warren, washington, and white counties. 179. for the criteria used by the u.s. department ofhealth and human services to desig­ nate an area as a medically underserved area, see u.s. dep't of health and human serv., health res. and serv. admin., guidelines for medically underserved area and population designation (2007), http:/ /bhpr.hrsa.gov/shortage/muaguide.htm. 2009] physician employee non-compete agreements 279 "medically underserved area" or a "health professional shortage area" in "primary medical care."180 the physician shortage is a particularly widespread problem in indiana. 181 at least one indiana court has explicitly invoked the public's interest in avoiding physician shortages. in fumo v. medical group of michigan city, inc., 182 the trial court granted the plaintiff medical group's request for a prelim­ inary injunction to enforce dr. furno's covenant not to compete after dr. furno voluntarily resigned. on appeal, the indiana court of appeals dissolved the preliminary injunction because the trial court failed to make any finding that the public interest would not be harmed.183 concerned about a shortage of medical services in the restricted area, the indiana court of appeals specifically in­ structed the trial court on remand to consider ''the availability of the particular specialty practiced by the physician .... "184 the court stated that "[w]here a specialist offers services uniquely or sparsely available in a specified geo­ graphical area, an injunction may be unwarranted because the movant is una­ ble to meet the burden of showing that the public would not be disserved."185 therefore, a thorough and serious evaluation of the public interest requires that indiana courts determine whether enforcing a physician restrictive covenant will either aggravate or alleviate the shortage of physicians in the state. d comparison to attorney non-compete agreements in the context of attorney employment agreements, restrictive covenants unquestionably violate public policy and legal ethics in lndiana.186 many of the same justifications for refusing to enforce attorney restrictive covenants apply with equal, if not greater, force to physician restrictive covenants. there are at least four justifications for the rule prohibiting lawyers from entering into non­ compete agreements. first, the official comment to the indiana rules of pro180. health professional shortage areas, supra note 33; mei>icallyunderserved areas, supra note 33. sixty-seven oflndiana's ninety-two counties contain areas designated as either "medically underserved" or having a ''health professional shortage": allen, brown, carroll, cass, clark, clay, clinton, crawford, daviess, decatur, delaware, elkhart, fayette, floyd, fountain, franklin, gibson, grant, greene, hendricks, henry, howard, huntington, jackson, jasper, jefferson, jennings, johnson, knox. la porte, lagrange, lake, laporte, madi­ son, marion, martin, miami, monroe, newton, ohio, orange, owen, parke, perry, pike, porter, posey, pulaski, putnam, randolph, ripley, rush, scott, spencer, st. joseph, starke, sullivan, switzerland, tippecanoe, union, vanderburgh, vermillion, vigo, warren, washington, wayne, and white counties. 181. but see med. specialists, inc. v. sleweon, 652 n.e2d 517, 525-27 (ind. ct. app. 1995) (rejecting statistics of the u.s. department ofhealth and human services as overly broad in favor of testimony that no patient had ever been refused treatment for a particular specialty). 182. 590 n.e.2d 1103 (ind. ct. app. 1992). 183. id at 110~. 184. id at 1109. 185. /d. (emphasis added). 186. ind. rules of prof. conduct 5.6(a)(2008)(prohibitinglawyersgenerallyftommak­ ing or offering agreements restricting the right of the lawyer to practice law). 280 indiana health law review [vol. 6:253 fessional conduct expressly states that a restrictive covenant is unethical for a lawyer because it "limits [the lawyers'] professional autonomy ... .''187 although the comment and rules may not explicitly say so, the purported principle behind this concern for the lawyer's professional autonomy is the lawyer's related duty to exercise independent professional judgment. 188 but a physician is under no less a duty than lawyers to exercise independent professional judgment when providing medical services.189 even so, it is unclear why the professional au­ tonomy of a lawyer is more worthy of protection than the professional autono­ my of physicians. second, the official comment to the indiana rules of professional con­ duct also justifies its rule based on the "freedom of clients to choose a law­ yer."190 again, why is the freedom of clients to choose a lawyer more important than the freedom of patients to choose a doctor? arguably, consumers have a stronger interest in freely choosing their physician than in freely choosing their lawyer, because medical services affect a patient's highly personal interest in bodily integrity, whereas legal services generally affect only a client's economic and financial interests (although admittedly that is not always the case). the fact that patients are willing to pay more for the freedom to choose their physi­ cian 191 supports the proposition that consumers value interests in their own health and bodily integrity over their own financial and economic interests. third, other authorities have relied on the important public service that at­ torneys provide and the duty to make those services available to the public to justify the ban on attorney non-compete agreements. 192 the services of physi­ cians, however, are no less important (and arguably more important) to the pub­ lic than the services of attorneys. moreover, physicians are likewise under an ethical duty to make their services widely available to the public. 193 finally, ethical prohibitions on attorney restrictive covenants have been justified based on the attorney's confidential and fiduciary relationship with the client. 194 as with attorneys, physicians are likewise engaged in a confidential 187. /d. at 5.6, cmt. l. 188. /d. at 5.4( c) (prohibiting a lawyer from allowing a third party, including an employer, to direct the lawyer's professional judgment in rendering legal services). 189. e.g., am.med.ass'n, codeofmedicalenncs(2009),supranote 131, § e-8.041 (requiring physicians who provide second opinions to exercise independent professional judg­ ment). 190. ind. rules of prof. conduct 5.6(a), cmt. l (2008). 191. see supra pp. 38--41. 192. see, e.g., dwyerv. jung, 336 a.2d498, 501 (n.j. super. ct. ch. div. 1975) (refusing to enforce an attorney restrictive covenant based in part on the duty of attorneys to make servic­ es fully available to the public); murfreesboro med. clinic, p.a. v. udom, 166 s.w.3d 674, 683 (tenn. 2005) (recognizing the duty shared by both physicians and attorneys alike to make their respective services available to the public). 193. see am. med. ass'n, code of medical etijics (2009), supra note 132, § e-9.065 (ethical obligation to care for the indigent); id § e-9 .067 (ethical obligation to provide services in event of public disaster). 194. karlin v. weinberg, 390 a.2d 1161, 1171 (n.j. 1978) (sullivan, j., dissenting) 2009) physician employee non-compete agreements 281 and fiduciary relationship with their patients.195 not only do ethics rules ex­ pressly recognize the fiduciary nature ofboth the physician-patient and the at­ torney-client relationships, but deep-rooted evidentiary rules also recognize the importance of protecting confidential communications in both relationships.196 the public service ofboth physicians and attorneys, as well as the nature of the relationship between the two professions and their respective clients or patients, are very similar, yet the rules governing restrictive covenants in the two professions exhibit a glaring disparity. this lack of any substantive differ­ ence between physicians and attorneys leaves one wondering whether the dis­ parity in the rules simply reflects an arrogant self-assessment of the legal profession's value to the public. rather, the public importance of physician services ought to be similarly recognized by subjecting physician non-compete agreements to more rigorous review. c. the circumstances surrounding the physician's departure this note thus far has advocated a more faithful application of the tradi­ tional analysis, namely, that courts should more strictly scrutinize both the em­ ployer's alleged protectable interests as well as the restrictive covenant's impact on the public interest. there are, however, other considerations that may not necessarily fit neatly within the traditional framework but are nonetheless ap­ propriate and relevant to a .. more exacting" review of the restrictive covenant's overall reasonableness and fairness. one such consideration is the circums­ tances surrounding the physician's termination, particularly where the court is called upon to exercise its equitable powers.197 logically, the circumstances of the employee-physician's tennination will generally fall into one of three possi­ ble categories: (1) the physician voluntarily resigns or the employer terminates the physician for cause, (2) the employer in good faith terminates the physician but without cause, or (3) the employer terminates the physician in bad faith. while the circumstances surrounding the physician's departure should be con­ sidered as a factor, they need not be the determinative factor. 198 each situation identified above raises a different set of equities that warrant differing factorial weights, as discussed below. 195. am.med.ass'n, codeofmedicaletiucs(2009),supranote 132, § e-10.01 (physi­ cian must not reveal confidential communications with a patient); id. § e-10.015 (physician­ patient relationship is based on trust and physician's fiduciary responsibilities to patient). 196. ind. code§ 34-46-3-1(1)(2007)(privilegeforattomey-clientcommunications); id § 34-46-3-1 (2) (privilege for physician-patient communications). 197. see, e.g., gomezv. chuamed. corp., 510n.e.2d 191, 195 (ind. ct.app.1987)(''if the tennination is made in bad faith, equity may be called upon to deny enforcement [of the restrictive covenant] .... "). 198. see kenneth j. yanko, "you're fired! and don't forget your non-compete .•. ": the enforceability of restrictive covenants in involuntary discharge cases, 1 depaul bus. & com. l.j. 1, 16-17 (2002) (criticizing reliance on the circumstances of an employee's termina­ tion as sole consideration in detennining whether to enforce a non-compete agreement). 282 indiana health law review [vol. 6:253 1. voluntary resignation or termination for cause this first situation presents the easiest case for enforcement for a couple of reasons. first, it is arguably the exact situation that the employer sought to protect against when requiring the restrictive covenant in the first place, i.e., the physician-employee voluntarily leaves before the employer has recovered its capital investment. additionally, the employee could have avoided the cove­ nant's adverse effects simply by continuing employment or refraining from his bad conduct. in other words, the employee in this situation is in control of the restrictive covenant's application. as for the rights of the patients to obtain continuing care, as long as the physician gives them sufficient notice to find a replacement physician, this situation is no different than if the physician simply withdrew from practice.199 thus, a physician's voluntarily resignation should weigh in favor of enforcing the restrictive covenant. two indiana cases illustrate this observation, although neither decision expressly acknowledges that the circumstances surrounding the physicians' termination should be a separate consideration. the first case is raymundo v. hammond clinic association200 which was previously discussed above at length in section m.b. the facts and outcome of raymundo are consistent with the theory that the employee's voluntary resignation weighs in favor of enforcement. in raymundo, dr. raymundo signed a five-year partnership agreement but voluntarily withdrew from the partnership after only two years to begin his own independent practice. 201 the raymundo court upheld the restric­ tive covenant because "[it] did nothing more than protect the clinic's goodwill against piracy by a mutinous partner. "202 thus, without expressly acknowledg­ ing the effect that dr. raymundo's voluntary resignation had on the enforcea­ bility of the restrictive covenant, the raymundo court may have been persuaded by dr. raymundo's voluntary withdrawal from the partnership. 203 second, central indiana podiatry, p. c. v. kruege-?04 illustrates how an employee's termination for cause may help justify enforcing the restrictive co­ venant. in krueger, a female employee complained that dr. krueger had tried to kiss her while they were working together in the clinic's kokomo, indiana office?05 in the clinic's ensuing investigation, dr. krueger admitted not only to that incident but also to an incident with another employee involving "some 199. 844ind. admin. code 5-2-16(b) (2007) (providing that a physician who retires from practice, discontinues a practice, or moves away from the community, must notify all ofhis or her active patients in writing that the practice is being discontinued and that the patient should seek another physician). 200. 449 n.e.2d 276 (ind. 1983). 201. /d. at 277-78. 202. /d. at 279. 203. id at 278. 204. 882 n.e.2d 723 (ind. 2008). 205. /d at 726. 2009] physician employee non-compete agreements 283 sort of touching. "206 anticipating that the clinic would terminate him, dr. krueger took a list of his current patients?07 the clinic then terminated dr. krueger?08 again, as with raymundo, the krueger court nowhere expressly discusses whether dr. krueger's conduct has any effect on the restrictive cove­ nant' s enforceability, but the court did enforce the covenant, at least in part.209 there may be a downside, however, to relying on a "for cause" termina­ tion as a factor in determining whether to enforce a covenant not to compete. if employers understand that terminating a physician "for cause" will weigh in favor of enforcement, they may try to create a pretextual reason for termination to enhance the likelihood that the covenant not to compete will be enforced. moreover, any subsequent litigation as to the enforceability of the restrictive covenant may become unduly focused on the collateral issue of whether the employer had "just cause" for the termination.210 if this factor was determina­ tive, such concerns would probably be justified. but a "for cause" termination should merely be one of many factors, making it unlikely that employers will try to find excuses to terminate a physician or that the existence of cause will dominate the litigation. 2. bad faith termination if a physician's voluntary resignation makes an easier case for enforce­ ment, an employer's bad faith similarly makes an easier case for refusing to enforce the restrictive covenant. although there are no indiana cases directly on point,211 a seventh circuit case from neighboring lllinois is illustrative. in rao v. rao,212 the employee surgeon entered into an employment agreement with a surgery practice group that would have allowed him to purchase a fifty­ percent ownership in the practice for one dollar after four years of service. 213 the agreement also provided that if the employee surgeon was terminated "for any reason" before acquiring his ownership interest, he would be subject to a restrictive covenant.214 although the employer and employee enjoyed a good working relationship, the employer sent a notice of intent to terminate the em­ ployee, effective a mere ten days before the employee became eligible to pur206. this fact is omitted from the indiana supreme court's opinion but was included in the lower appellate court's decision. see krueger, 859 n.e.2d at 689. 207. krueger, 882 n.e.2d at 726. 208. id. 209. id at 734. 210. for a discussion of the problems with the "for cause/without cause" distinction in evaluating restrictive covenants, see vanko, supra note 198, at 23-25. 211. there is dictum, however, indicating that indiana courts would be willing to refuse to enforce a restrictive covenant in the face of an employer's bad faith. gomez v. chua med. corp., 510n.e.2d 191, 195 (ind. ct. app. 1987) ("if the termination is made in bad faith, equi­ ty may be called upon to deny enforcement [of the restrictive covenant] .... "). 212. 718 f.2d 219 (7th cir. 1983). 213. id. at 221. 214. id. 284 indiana health law review [vol. 6:253 chase the fifty-percent ownership interest. 215 moreover, the letter containing the notice of intent to terminate invited the employee to negotiate a ''new rela­ tionship" with the employer?16 thus, the only apparent reason that the em­ ployer terminated the employee was to prevent the employee from exercising his buy-in option under the agreement. 217 when the employee continued to practice surgery in violation of the restrictive covenant, the employer brought suit to enforce the covenant. 218 applying illinois law, the seventh circuit held that because the employer terminated the employee in bad faith and without cause, it was precluded from enforcing the restrictive covenant. 219 the existence of an employer's bad faith should weigh heavily in favor of refusing to enforce a restrictive covenant primarily because, as the rao court recognized, the necessity for a restrictive covenant in such a case is virtually nonexistent. 220 obviously, an employer requires an employee to sign a non­ compete agreement out of a concern that the employee will quit and begin competing with the employer. if the employer is so concerned about competi­ tion, then it should not terminate the employee-especially in bad faith. in such a case, the employer certainly does not suffer injustice if the restrictive covenant is not enforced. thus, a bad faith termination by the employer should weigh heavily in favor of refusing to enforce a non-compete agreement. 221 3. good faith termination without cause perhaps the most difficult situation is where an employer tenninates an employee without cause but does so in good faith. in this situation, the em­ ployer may have a number oflegitimate reasons for terminating the employee other than the employee's misconduct, such as purely business or financial rea­ sons. the indiana court of appeals had occasion to address this situation in gomez v. chua medical corp. 222 there, dr. gomez was tenninated without cause and set up his own practice in violation of a restrictive covenant in his employment agreement. 223 the court of appeals expressly rejected dr. gomez' argument that the employer should have to prove it had "good cause" to termi­ nate him as a condition to enforcing the restrictive covenant.224 in rejecting this argument, the court expressed concern that such a rule would invite excessive 215. id 216. id 217. id at222. 218. id at 221. 219. ld at224. 220. id. 221. one commentator has criticized an approach that focuses solely on the existence of bad faith as the determinative factor. yanko, supra note 197, at 25-26. the approach advo­ cated here, however, considers the existence ofbad faith merely as one factor, albeit a relatively heavily weighted factor. 222. 510 n.e.2d 191 (ind. ct. app. 1987). 223. ld. at 193. 224. id at 195. 2009] physician employee non-compete agreements 285 litigation over whether "good cause" existed. 225 the court was also persuaded by the strong public interest in the freedom to contract, including the freedom to enter into contracts that are ''unwise or even foolish!.226 on the one hand, the freedom to contract acknowledges that the em­ ployee-physician should have appreciated the risk of a ''termination without cause" in negotiating his employment agreement because the clinic did not act in bad faith, it should not be penalized for a condition that is reflected in the bargain. moreover, if an employer terminated the employee for financial rea­ sons, then the employer is presumably struggling fmancially, arguably heigh­ tening its need to enforce the restrictive covenant in order to survive. on the other hand, enforcing a restrictive covenant in this situation is un­ fair to the employee-physician because he is willing and able to work for the employer rather than to compete against it. the employer has a legitimate in­ terest in requiring a restrictive covenant to protect its investment in its em­ ployees-whether a financial, educational, or informational investment-to ensure that the investment produces a return for the benefit of the employer ra­ ther than its competitors. but if the employer voluntarily relinquishes the abili­ ty to profit from that investment by prematurely terminating the employee, it is unfair to burden the employee (who is otherwise willing to produce a return for the employer) with finding a different market in which to benefit from that in­ vestment. thus, to a certain extent, enforcing a restrictive covenant in this situ­ ation gives the employer more protection than the scope of his legitimate interests. the parties on both sides of this situation have strong equitable argu­ ments. when weighing the circumstances surrounding the physician's termina­ tion without cause and in good faith, the balanced interests suggest giving this factor neutral weight in the final analysis. treating this factor neutrally may mitigate concerns that the litigation will be unnecessarily consumed with whether the employer had "good cause" to terminate the employee. while the employer need not prove good cause, it may present evidence of good cause to bolster its case for enforcing the restrictive covenant. d. consideration of the remedy sought another potential factor in evaluating whether to enforce a physician's re­ strictive covenant is the type of remedy that the employer is seeking. employ­ ment agreements with restrictive covenants sometimes include a waiver provision whereby the employee may pay a pre-determined amount as liqui225. id. 226. id. perhaps more accurately, the court felt constrained by the indiana supreme court'sdecisioninraymundo.449n.e.2d276(1nd 1983). inaconcmringopinion,amajority of the panel indicated that, but for the indiana supreme court's decision in raymundo, it would have been willing to strike down the restrictive covenant as against public policy. gomez, 510 n.e.2d at 196-97 (sullivan, j., concurring). 286 indiana health law review [vol. 6:253 dated damages for the privilege of violating the restrictive covenant.227 thus, employers may seek to enforce the employment agreement either by obtaining injunction relief against the physician's competing practice or by obtaining a liquidated damages award. the type of remedy sought affects the analysis of the public's interest and should be considered independently. i. liquidated damages liquidated damages are less burdensome on public interests than an in­ junction restraining the physician from practicing medicine. while the physi­ cian may personally suffer by incurring the additional costs of liquidated damages, the public nonetheless benefits through the physician's continued services. of course, it could be argued that if the liquidated damages are too steep, the physician will be forced to submit to the restrictive covenant and withdraw from practice. while that argument certainly presents a legitimate concern, there are two mitigating considerations here. first, liquidated damages must not be grossly disproportionate to the potential losses that the non­ breaching party will suffer. 228 this rule protects against overreaching and ex­ orbitant liquidated damages amounts. second, even in the absence of a restric­ tive covenant, a physician is free to leave his practice at any time. nothing in the law requires him to practice. thus, even if the physician chooses to submit to the restrictive covenant rather than pay the liquidated damages, at least ali­ quidated damages provision gives him the option to make that decision rather than having it forced on him. 2. injunctive relief unlike a liquidated damages remedy, if injunctive relief is sought, a doc­ tor who wants to continue practicing will be prevented from providing medical services. this forced withdrawal of medical services will more substantially burden both the public's interest in having a physician's services available and an individual patient's interest in freely choosing the highly personal services that a physician provides. in the seminal indiana case on this subject, raymun­ do v. hammond clinic association, 229 the indiana supreme court did not have occasion to consider the injunctive remedy for enforcing a restrictive covenant, a fact that has been overlooked in subsequent indiana decisions. in fact, the court stated, "[w]e are here concerned only with the paragraph [of the com227. see, e.g., raymundo, 449 n.e.2d at 276 (liquidated damages of$25,000 for a viola­ tion during the first year of the two-year restrictive covenant and $15,000 for a violation during the second year); gomez, 510 n.e.2d at 191 (liquidated damages of$50,000 to practice in viola­ tion of the restrictive covenant); sharvelle v. magnante, 836 n.e.2d 432 (ind. ct. app. 2005) (agreement provided that the employer will waive the restrictive covenant in exchange for pay­ ment of$300,000 as liquidated damages). 228. gomez, 510 n.e.2d at 193. 229. raymundo, 449 n.e.2d 276. 2009] physician employee non-compete agreements 287 plaint] seeking damages, [since the request for injunctive relief] ha[s] become moot with the passage of time, during the pendency of the action in the trial court .... "230 therefore, a close and narrow reading of raymundo reveals that the indiana supreme court has not yet considered the precise issue of whether a physician restrictive covenant may be enforced by injunctive relief. due to the heightened burden on the public interest and on patients' rights that an injunction may impose, courts should weigh a request for injunctive relief in favor of refusing to enforce a restrictive covenant. as with the other factors, this factor need not be determinative, but should be taken into consider­ ation in light of the other factors to consider. e. heightened burden of proof for enforcement: clear and convincing evidence finally, a more scrutinizing review of non-compete agreements could in­ clude imposing a greater burden of prooffor the employer. although the ques­ tion of a restrictive covenant's reasonableness is a question of law,231 this determination must nonetheless be based on facts relevant to the traditional in­ quiry, such as facts surrounding the employer's protectable interest and any adverse effects on the public. while a heightened burden of proof on the em­ ployer has not yet been discussed in any indiana case, a line of cases from neighboring ohio has imposed the clear and convincing standard on employers seeking to enforce restrictive covenants. in ohio urology, inc. v. pol/,232 the employer sought to enforce a restrictive covenant contained in the physician­ employee's employment agreement upon the employee's departure. the trial court granted the employee's motion for summary judgment on the grounds that the covenant violated public policy and was per se unenforceable. 233 the court of appeals of ohio reversed, rejecting the "per se invalid" rule in favor of the "demanding scrutiny'' rule. 234 although the court remanded the case for a full hearing on the issue of the employer's entitlement to a preliminary injunction, it noted that the disfavored status of restrictive covenants placed a burden on the employer "of producing clear and convincing evidence as to each element [of the traditional rule]."235 in the usual civil case, the plaintiff must prove its case by a preponderance of the evidence. 236 but in the usual civil case between two private parties there 230. id at 278-79. 231. id. at 280. 232. see, e.g., ohio urology, inc. v. poll, 594 n.e.2d 1027, 1032 (ohio ct. app. 1991) (employer must prove each element of the reasonableness test by clear and convincing evi­ dence). 233. id at 1030. 234. id at 1031-32. 235. id at 1032. 236. see, e.g., bonnell v. sabbagh. 670 n.e.2d 69, 71 (ind ct. app. 1996) (''the general rule in indiana is that, in civil actions, the rights of the parties are to be determined by a prepon288 indiana health law revjew [vol. 6:253 is generally little concern that enforcing one party's rights will have an adverse impact on the public interest. given the possible adverse effects that enforcing a physician's restrictive covenant may have on the public interest, requiring the employer to prove each element of its case by clear and convincing evidence provides a greater level of certainty that the public will not suffer as a result of enforcing the employer's private rights. a heightened burden of proof may not make much difference with respect to some of the facts necessary to determine reasonableness, such as the geo­ graphic scope of the restriction, the time limits of the restriction, or the scope of prohibited activities. but it would require the employer to prove with clear and convincing evidence that he has legitimate business interests that must be pro­ tected by a restrictive covenant. a heightened evidentiary requirement may discourage the use of restrictive covenants except where there is a greater need to protect tangible (i.e., provable) business interests. v. conclusion the standard for reviewing physician restrictive covenants under current indiana law is not entirely clear. the krueger court indicated it was following the earlier raymundo decision, in which a physician's covenant not to compete was simply held to a reasonableness standard-the same standard that applies to a shoe salesman's covenant not to compete. 237 on the other hand, krueger court also indicated that physician non-compete agreements "should be given particularly careful scrutiny."238 in the commercial context, the abbreviated analysis prevalent in raymun­ do adequately weighs the public's economic interests in securing a competitive marketplace against the employer's business interests.239 but in the context of a physician's services, the public's interests are not solely economic. instead, those interests extend to a patient's interest in uninterrupted treatment oflong­ term illnesses, a patient's interest in choosing which doctor will perform highly personal services that affect his bodily integrity, and the public's interest in preventing physician shortages that impact overall public health-interests which indiana's current approach fails to adequately consider. a rule that physician restrictive covenants are per se invalid certainly re­ cognizes the public's broader interests and provides bright-line guidance to both employers and employees, but it ignores the legitimate need of employers to protect their investment in hiring and training physician employees. it also denies the flexibility needed to recognize that in some instances the public's interest may actually be furthered by enforcing a physician restrictive covenant. rather, indiana courts should subject physician restrictive covenants to a more stringent standard than other commercial covenants not to compete. a derance of the evidence."). 237. cent. ind. podiatry, p.c. v. krueger, 882 n.e.2d at 723,728 (ind. 2008). 238. id. at 729. 239. see supra pp. 5-6. 2009] physician employee non-compete agreements 289 more exacting scrutiny of physician restrictive covenants, as at least suggested by the krueger court, will require a strict and faithful application of the tradi­ tional rules.240 this approach would require an employer to prove its legitimate protectable business interests and the absence of harm to the public before its restrictive covenant could be enforced. indiana courts should deliberately con­ sider all aspects of the public's interest, including whether enforcement may actually enhance access to medical services. in determining whether the restric­ tion is ''reasonable," courts should also consider (1) whether the employee vo­ luntarily left the employment or was terminated for cause, (2) whether the employer terminated the employee without cause, and if so whether such termi­ nation was in good faith, (3) whether the agreement adequately provides for the rights of existing patients to follow a physician to a new practice, and (4) whether the agreement's remedy includes payment of damages or is limited to injunctive relief. ultimately, the legislature is responsible for declaring the public policy of the state and should adopt a statutory response with these principles in mind. but even in the absence oflegislative action, indiana courts should not hesitate to aggressively protect the public's interest in the availability of medical servic­ es. such action by the courts, at least in the context of physician restrictive co­ venants, should not be perceived as an affront on the legislature's prerogative in setting the public policy of the state, but rather a faithful application of a long-standing rule requiring the judiciary to evaluate the public effects of en­ forcing a private right. by doing so, indiana courts can do their part to ensure that hoosier patients will have the access they need to adequate medical servic­ es, while enabling employers to protect their investment in training and hiring the next generation of physicians. 240. see krueger, 882 n.e.2d at 729. proper preemption or contrned construction?: why section 360k(a) of the fdca should not be interpreted to preempt state common law tort claims travis p. meek• introduction pursuant to section 360k(a) of the federal food, drug, and cosmetic act, a state may not impose requirements on a medical device that are different from, or in addition to, the requirements already imposed upon the device by the federal food and drug administration ("fda").1 while this express preemption provision may appear straightforward on its face, a question remains regarding its effect on state common law tort claims, such as negligence and strict liability, when the device in question has been approved through the fda's rigorous pre-market approval process. several courts, such as the third, seventh, and ninth circuit courts of appeals, have concluded that state common law tort claims involving federally approved medical devices are expressly preempted by section 360k(a) because they represent an attempt to impose state requirements upon medical devices that are different from, or in addition to, federal requirements. 2 on the other band, the tenth and eleventh circuit courts of appeals have reached the opposite conclusion, declaring that state common law tort claims are not preempted by section 360k(a), either because the state claims are too general to be regarded as imposing specific, conflictingrequirements,3 or because the federal medical device approval process does not impose substantive requirements on devices with which a state requirement could possibly conflict.4 the supreme court * j.d., 2005, indiana university school oflawindianapolis; b.a., 2001, dartmouth college, hanover, new hampshire. i would especially like to express my gratitude to my mother, filther, and siblings, frank, caroline, and sarah, for their lifelong encouragement and support. in addition, i would like to thank dr .. brad kallmyer and daniel byron for the helpful suggestions and invaluable insight they provided me while i wrote this note. 1. 21 u.s.c. § 360k(a)(2005). the statute provides: (a) general rule[.] except as provided in subsection (b) of this section, no state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement-(!) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 2. hom v. thoratec corp., 376 f .3d 163 (3d cir. 2004); mitchell v. collagen corp., 126 f.3d 902 (7th cir. 1997); papikev. tambrands, inc., 107 f.3d 737 (9th cir. 1997). 3. oja v. howmedica, inc., lll f.3d 782 (loth cir. 1997). 4. goodlin v. medtronic, inc., 167 f.3d 1367 (11th cir. 1999). 232 indiana health law review [vol. 3:231 of the united states has yet to resolve the circuit split. 5 nonetheless, through its fractured 1996 plurality opinion in medtronic, inc. v. lohr, the court appears to suggest that section 360k(a) should not be interpreted as preempting most state common law tort claims involving medical devices.6 the ensuing discussion will advocate the uniform adoption of the tenth circuit's approach to this conflict by all courts. state common law tort claims merely involve the imposition of general requirements, such as the duty to use good care in manufacturing, therefore, they cannot possibly conflict with federally imposed requirements and are not preempted by section 360k(a). this approach is favorable because it most accurately reflects congressional intent to adhere to the presumption against federal preemption of state public health and safety regulations suggested by the supreme court, 7. and it serves important public policy considerations. the most effective method of accomplishing the uniform interpretation of section 360k(a) would be through a congressional· amendment to the statute. in the absence of congressional action, however, the fda could issue a clarification regulation directly addressing section 360k(a)'s preemptive reach, or the supreme court could settle the debate by granting certiorari to· hear a case involving this issue. regardless of the method by which it oocurs, it is imperative for the legal community to arrive at a consistent understanding ofthe preemptive scope of section 360k(a), preferably one that adopts a narrow interpretation. part i of this note describes the facts and outcome of the recently decided third circuit court of appeals case, horn v. thoratec, corp., in order to illustrate the real-world context within which the present issue arises. part ll of this note addresses the 1976 amendments to the food, drug, and cosmetic act ("fdca"), with particular emphasis placed on the pre-market approval process for medical devices. part ill then discusses the different interpretations of section 360k(a)'s preemptive effect held by the supreme court and the circuit courts of appeals. part iv proposes that the eleventh circuit was correct in concluding that section 360k( a) does not preempt state tort claims, but suggests that the court's reasoning was flawed. part v explains that the tenth circuit was correct, not only in its conclusion that section 360k(a) does not preempt state tort claims, but also in its reasoning. part vi discusses the appropriate amount of weight that courts should afford to amicus curiae briefs submitted by government agencies, and suggests that 5. see, e.g., medtronic, inc. v. lohr, 518 u.s. 470, 495 (1996) (where the supreme court declared. "[t)he different views expressed by the courts of appeals regarding the appropriate scope of federal pre-emption under [section] 360k demonstrate that the language of that section is not entirely clear."). see also, wilson v. bradlees ofnew eng., lnc., et al., 96 f.3d 552, 556 (1st cir. 1996) (explaining that, "[f]or the moment, the supreme court's inclination is balanced almost on a knife edge, as the divisions in lohr amply confirm."). 6. lohr, 518 u.s. at470-71. 7. id. at484-85. 2006] proper preemption or contrned construction? 233 the third circuit gave undue deference to the fda's amicus brief in hom v. thoratec, corp. part vii concludes this note by reiterating the superiority of the tenth circuit's interpretation of section 360k( a) and offers suggestions for the means by which such an approach could be uniformly adopted by the entire legal community. i. recent treatment of the issue: horn v. thoratec, corp. a. facts on january 17, 1998, daniel ray hom was admitted to williamsport hospital in williamsport, pennsylvania after suffering an acute myocardial infarction. 8 soon after his arrival, hom was transferred to hershey medical center, where the attending physicians concluded that he desperately needed a heart transplant in order to stay alive. five days later, while waiting for a suitable transplant donor, hom's condition worsened. as a result, hom and the doctors at hershey agreed on the insertion of a heart pump to assist his heart in circulating blood throughout his body while he waited for a donor. the heart pump the hershey doctors chose for the procedure was one manufactured by thoratec corporation,9 called the "heartmate lv ad."10 this device contains a central pump "body," with two major tubes extending from each side. one of the tubes connects directly to the heart and is designed to pump blood from the heart's ventricle into the pump body. this side ofthe pump is called the "inlet side." once blood has entered the pump body through the inlet side, it then exits the pump body through the other tube located on the "outlet side" which is connected directly to the aorta. once blood flows through the outlet side into the aorta, it is dispersed throughout the body. in addition to the pump body, both ofthe major tubes are connected to a circle-shaped pump housing, to which a third tube is also connected. this third tube is designed to exit the body and connect to an air compressor, which forces air through the tube and into a pump, thereby assisting the heart's 8. "myocardial infarction" is the medical term for heart attack. taber's cyclopedic medical dictionary defines it as "[ d]evelopment of an infarct in the myocardium, usually the result of myocardial ischemia following occlusion of a coronary artery." its symptoms include "[p]ain similar to that of angina pectoris, shock, cardiac failure with arrhythmia, and frequently sudden death." taber's cyclopedic medical dictionary m-80 (clayton l. thomas ed., 13th ed. 1973). 9. thoratec corporation was formerly known as thermo cardiosystems, inc. when barbara hom brought suit against thoratec in the middle district court of pennsylvania following her husband's death, the named defendant was "thermo cardiosystems, inc." hom v. thoratec corp., 299 f.supp.2d 381 (m.d. penn. 2002). 10. "lv ad" stands for "left ventricular assist device." it is worth mentioning that the heartmate lv ad is pre-assembled when it arrives at the surgeon; no further assembly is required before implantation. hom, 376 f.3d at 164 n.3. 234 indiana health law review [vol. 3:231 circulation of blood from the ventricle to the aorta, via the two major tubes already described. on may 3, 1998, hom began experiencing problems with his heartmate lv ad, evidenced by bleeding at the location where the air compressor tube exited his body. consequently, he returned to hershey medical center where an experienced cardiothoracic surgeon, dr. benjamin sun, performed exploratory surgery to determine the source of the problem. upon closely examining horn's heartmate, dr. sun discovered that the outlet tube had become disconnected to the pump housing at a point known as the "elbow." designed to connect the outlet pump and the pump housing, the elbow is an integral part of a fully functioning heartmate. in hom's case, however, the screw ring that connected the elbow to the pump housing had become disconnected, thus disrupting the flow of blood through the heartmate. although dr. sun immediately attempted to reconnect the elbow to the pump housing using a metal wire instead of the screw ring, he was unable to save horn's life. the disconnection had allowed an air embolus11 to travel to horn's brain, which caused him to suffer a fatal brain hemorrhage. he was pronounced dead on may 8, 1998. b. the trial following her husband's death caused by the poorly constructed heartmate, barbara horn brought suit against thoratec corporation in the middle district court of pennsylvania, alleging claims of negligence, strict liability, and breach ofwarranty.12 in response, thoratec moved for summary judgment, arguing that mrs. hom's claims were preempted by section 360k( a) 11. taber's cyclopedic medical dictionary defines "embolus" as: [a] mass of undissolved matter present in a blood or lymphatic vessel brought there by the blood or lymph current. emboli may be solid, liquid, or gaseous. other emboli may consist of bits of tissue, tumor cells, globules of fat, air bubbles, clumps of bacteria, and foreign bodies such as bullets. emboli may arise within the body or they may gain entrance from without. occlusion of vessels from emboli usually results in the development of infarcts. taber's cyclopedic medical dictionary e-19 (clayton l. thomas ed., 13th ed. 1973). furthermore, an "air embolus" is "[ a]n air bubble in the veins, right atrium or ventricle, or capillaries." taber'scyclopedicmedicaldictionary e-19 (clayton l. thomased., 13th ed. 1973). 12. specifically, mrs. horn's negligence claims included: "1) failure to test and study adequately the heartmate; 2) failure to provide adequate warnings regarding the possibility that the screw ring may disconnect; 3) failure to provide adequate instructions to physicians; and 4) failure to use proper suture material." additionally, mrs. hom's strict liability claims included: "1) failure to use 'good manufacturing practices'; and 2) failure to provide adequate warnings." finally, mrs. hom specifically alleged that thoratec "breached the implied warranties of merchantability and fitness." hom v. thermo cardiosystems, inc., 229 f. supp. 2d 381, 385 (m.d. pa. 2002). 2006] proper preemption or contrived construction? 235 ofthe federal food, drug, and cosmeticsact ("fdca").13 according to this section of the fdca: [n]o state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement{ i) which is different from, or in addition to, any requirement applicable under [the fdca] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the fdca].14 thoratec argued that a state common law tort claim, such as those set forth in mrs. hom's complaint, would impose requirements on its heartmate that would be different from, or in addition to, the requirements already imposed upon it by the fda. accordingly, thoratec argued that the express preemption provision contained in section 360k(a) entitled it to summary judgment. in response to thoratec's motion for summary judgment, the middle district court ofpennsylvania agreed with thoratec's reasoning and granted the motion. basing this decision on a close reading of section 360k(a), the court declared that "[t]he key ... is to focus first on the specificity and applicability of the federal requirement and second, if necessary, on whether the state claim is different from or in addition to the federal requirement."15 as the heartmate's safety and effectiveness was verified through the fda's rigorous pre-market approval ("pma") process, the court decided that specific federal requirements had been imposed upon the heartmate, to which no state requirement could add or differ. 16 the court's next task was to determine whether mrs. hom's state common law tort claims represented an attempt to impose additional or different requirements upon the heartmate. reasoning that because most of mrs. hom's claims related to the design and effectiveness of heartmate, which the fda had already addressed and approved through its pma process, the court concluded that the state common law tort claims at issue were preempted by section 360k(a), declaring that "[a]ny judgment that the heartmate was unsafe or otherwise substandard would be in direct conflict-i.e., different from-the fda's determination that the product was suitable for use."17 accordingly, the court granted thoratec 's motion for summary judgment. 13. 21 u.s.c. § 301 et seq. (2005). 14. 21 u.s.c. § 360k(a)(l) (2005). 15. horn, 229 f. supp. 2d at 390. 16. id. at 389. 17. /d. at 390. 236 indiana health law review [vol. 3:231 c. the appeal understandably discontented with the district court's decision, mrs. hom appealed the judgment to the united states court of appeals for the third circuit.18 the central argument on appeal was that the state common law claims merely imposed the "generally applicable duties to use good care in manufacturing" and to issue adequate warnings of the device's risks.19 thus, mrs. hom contended that the state claims should not be preempted by section 360k(a) because they do not impose specific requirements that are different from, or in addition to, the federal, pma-imposed requirements.20 however, as the third circuit, in an opinion written by judge garth, agreed with the district court on all grounds and upheld the .grant of summary judglnent to thoratec. 21 the court stated that "[b ]ecause these state common law claims and duties are in severe tension with [section] 360k(a) in that they are either in addition to, or different from, the federal requirements established by the fda in approving the heartmate, they are necessarily preempted by federally imposed pma requirements under [section] 360k(a)."22 more specifically, the court noted the following: because the design of the heartmate, the labeling and the instructions for its use, and the specification of the suture and its location when the heartmate is implanted, as well as the other requirements imposed by the pma, were the subject of extensive consideration by the fda leading up to its pma approval, any fmding in hom's favor based on her general · claims of negligence or defective design and manufacture--be it by a jury or a court-would necessarily amount to a state substantive requirement "different from, orin addition to, the federal requirements imposed by the fda."23 any such finding would "stand as an obstacle to the accomplishment and execution of'' the objective of the safety and effective­ ness of the heartmate specifically and would conflict with the federal requirements imposed by the pma.24 18. hom, 376 f.3d at 163. 19. ld at 166. 20./d 21. ld at 164 (mrs. horn •s appeal was brought before a three-judge panel, consisting of judges ambro, fuentes, and garth). 22. /d at 177. 23. hom, 376 f.3dat 163 (quotingoeierv.am. honda motor co .• 529u.s. 861,873 (2000)). 24. /d. 2006] proper preemption or contrived construction? 237 in reaching its decision, the court admitted that it was heavily influenced by the sentiments expressed by the fda in its amicus curiae brief.25 most notably, the court relied on the fda's opinion that state common law actions of this nature are inappropriate because they threaten the federal regulatory framework for medical devices by encouraging lay judges and juries to second-guess decisions made by the experts at the fda regarding medical device safety and effectiveness.26 , . interestingly, however, the court's decision to affirm the district court's grant of summary judgment was met with vigorous dissent by one of the three judges on the panel, judge julio fuentes. while conceding that the pma process "is a specific federal regulation governing the heartmate;• judge fuentes argued that mrs. hom's state common law claims did not seek to impose any specific requirement on the heartmate, and therefore, should not be preempted by section 360k(a).27 rather, mrs. hom's common law claims sought to impose requirements of general applicability, which 21 c.f.r. section 808.l(d)(l)28 clearly removes from section 360k(a)'s preemptive realm.29 fuentes supported his position, not only with the federal regulation and favorable case law, but also with persuasive policy rationale, stating that, because the congressional purpose underlying the pma process is to ensure consumer safety, state common law suits, which work to hold device manufacturers responsible for the harm caused by their products, are integral to attaining congress' goal.30 nevertheless, mrs. hom's case, having been summarily adjudged in thoratec's favor, rendered her without remedy for her husband's death and relieved thoratec of any responsibility for the harm caused by its faulty product. following the third circuit's decision in favor of thoratec, counsel for mrs. hom did not apply to the supreme court for a writ of certiorari.31 as mrs. hom's unfortunate situation demonstrates, the legal community is presently engaged in a heated debate regarding the proper interpretation of the nature and extent of section 360k( a)'s preemptive effect. do general state common law tort claims involving the safety and effectiveness of medical 25. !d. at 177 (where the court explicitly declared that its ''preemption conclusion [was] reinforced by the informed analysis found in the fda's amicus curiae brief. .. ). 26. !d. at 178. 27. id at 180. 28. 21 c.f.r. § 808.l(d)(l) (2005) reads as follows: section [360k(a)] does not preempt state or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the [ucc] (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices. 29. horn, 316 f.3d at 182. 30. ld. at 185. 31. telephone interview with gary a. winters, partner, mayer, brown, rowe, & maw, llp, in washington d.c. (feb. 24, 2005) (mr. w'mters was counsel forthoratec corp.). 238 indiana health law revmw [vol. 3:231 devices impose requirements upon medical devices that are different from, or in addition to, federally imposed pma requirements, thus rendering them preempted by section 360k(a); or do the state claims merely impose generalized duties of care that are fundamentally consistent with the federal requirements, thereby leaving them outside of section 360k(a)'s preemptive scope? the following discussion will attempt to demonstrate why the latter interpretation is preferable, thereby advocating its uniform adoption by all u.s. courts.32 ii. the 1976 medical device amendments and the pma process following a rash of oonsumersuits against the manufacturers of medical devices in the early 1970s, especially those involving the alleged defects of the dalkon shield intrauterine device,33 congress attempted to ease public concern regarding the safety and effectiveness of medical devices by passing the 1976 medical device amendments to the fdca, codified at 21 u.s.c. section 360.34 among other things, the medical device amendments "confer[ ] broad regulatory authority over medical devices on the fda and establish[] a regulatory framework that classifies devices by the degree of risk posed to the public, subjecting devices that pose the greatest risk to the most exacting level of fda scrutiny."35 the classification framework consists of three different categories: class i devices are deemed to pose the least amount of risk, and are therefore subject to the lowest·level of scrutiny;. class ii devices are deemed to pose an intermediate amount of risk; and class ill devices· are deemed to pose the greatest amount of risk, and are therefore subject to the highest degree of scmtiny.36 class ill devices are defined as those which are either to be used for supporting or sustaining human life, are of substantial importance in preventing impairment of public health, or present a potential unreasonable risk of illness or injury. this classification includes pacemakers and heart 32. an alternative approach to that of the pment discussion (and one that is embraced by the eleventh circuit court of appeals) is to argue that state claims are not preempted by section 360k(a) because the federal pma process does not imp0$e device-specific requirements with which a state claim could possibly conflict. while the present discussion will focus on the general, and therefore un-preelnptable, nature of state common law claims, instead of the pma process's lack of specificity, readers shouldseesasba b. reiders, note, state law tort claims and the fda: proposing a consumer-oriented prescription in medical device cases, 25 cardozo l. rev. 1159 (2004), as well as part iv of this note, for a tl1orough discussion of that alternative approach. 33. see, e.g., in re a.h. robins, co., inc. "dalkon shield" iud products liab. litig., 406 · f. supp. 540 (j.p .m.l~ 1975); oregory j~ scaaidaglia & therese l. tuuy, express preemption and premarket approval under the medical device amendments, 59 food & drug lj. 245, 246(2004). 34. goodlin v. medtronic, inc., 167 f.3d 1367, 1369 (11th cir. 1999). 35. webster v. pacesetter, inc., 111 f. supp. 2d i, 4 (d.c. dist. 2001). 36. 21 u.s.c. § 360c(a)(l) (2005); hom, 229 f. supp. 2d at 385. 2006] proper preemption or contrived construction? 239 pumps, such as the heartmate lv ad. 37 in order to market a class m device within the united states, a manufacturer must submit its product to the fda in order for it to undergo a process called premarket approval ("pma").38 during the pma process, the fda closely investigates the product and, before approving it, must· conclude that the manufacturer has . adequately and reasonably demonstrated that the device is safe and effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. 39 the fda determines the safety and effectiveness of a device: (a) with respect to the persons for whose use the device is represented or intended, (b) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device~ and (c) weighing any probable benefit to health from the use ofthe device against any probable risk of injury or illness from such use.40 to show that a device is safe and effective, a manufacturer "must submit detailed information pertaining to the device, including all studies, reports, and other publications regarding its safety and efficacy; its component parts and functions, and the processes necessary to manufacture and package the device, as well as samples of the device, its labeling, and packaging.'"'1 on average, the fda spends approximately 1,200 hours reviewing the application before reaching a decision regarding its approval.42 while the general rule is that all class m devices must undergo the rigorous pma process, some may qualify for an exemption. one such exem.ption,codifiedat21 u.s.c.section360e(b)(l)(a-b),isforthosedevices which are "substantially equivalent" to a device that either (1) has already been approved through the pma process,43 or (2) was inexistence in 1976, "in order not to stifle competition with technology existing at the time of the (1976 medical·device amendments]. "44 this exemption, commonly referred to as ''the 51 o(k) process," typically subjects devices to only twenty hours of reviewbythefda,insteadoftheapproximatelyl,200hoursofreviewtypical of the pma process.45 as one would expect, the fda receives far more 37. 21 u.s.c. § 360c(a)(1xcxii)(i-ii)(2005). 38. horn, 229 f. supp. 2d at 385. 39. 21 u.s.c. § 360c(ax1xc) (2005); 21 u.s.c. § 360e(dx2xa~b) (2005). 40. 21 u.s.c. § 360c(ax2xa-c) (2005). 41. webster, 171 f. supp. 2dat4(quoting21 u.s.c. § 360e(cx1)(2001)and21 c.f.r. § 814 (2001)). 42. lohr, 518 u.s. at477. 43. 21 u.s.c. § 360e(bx1)(b) (2005). 44. in rest. jude med., inc. silzone heart valves products liab. litig., no. 01-1396 (jrtifln), 2004 u.s. dist. lexis 148, at *7-8 (d. minn. jan. 5, 2004). 45. horn, 229 f. supp. 2d at 385. 240 indiana health law review [vol. 3:231 applications for medical device approval under the simplified 51 o(k) process than under the lengthy pma process.46 according to a 1983 house report, approximately 1,000 of the l,lqoclass ill medical devices that had been introduced into the .market since 1976 were approved through the 510(k) process.'17 more recent data, submitted by the fda in its hom v. thoratec, corp. amicus curiae letter, reveals that this trend has continued. of the 9,872 submissions for medical device approval in 2003, only fifty-four proceeded via the pma process.48 another exemption to the pma process is the investigational device exemption ("ide"), which, as its title suggests, is for devices that qualify as investigational under section 360j(g) of the fdca.49 the purpose of this exemption is "to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose. "50 these investigational devices are to be used by experts with sufficient scientific knowledge and training so that they may adequately evaluate their safety and e:ffectiveness.51 experts qualified to use these devices must, amongst other things, maintain thorough records and submit reports to the secretary of health and human services detailing the information gained while investigating the device. 52 thus, in addition to the 51 o(k) process, the ide exemption, created to ''foster the development of useful devices, "53 represents another means by which a medical device may reach the market without frrst being subjected to the rigorous pma process. finally, and most notably for the present discussion, the 1976 medical device amendments contain 21 u.s.c. section 360k(a), the much-debated express preemption provision. this section of the fdca obtusely declares that no state or political subdivision may establish any requirement, with respect to a medical device, that is different from, or in addition to, any requirement imposed by the fda under the fdca. 54 two clauses of the united states constitution made it possible for congress to pass section 360k(a): the supremacy clause and the dormant commerce clause. first, by declaring that "[t]he laws ofthe united states ... shall be the supreme law 46. see gail h. javitt, i've got you under~ skinand i can't get redress: an analysis of recent case law addressing preemption of manufacturer liability for class iii medical devices, 49 fooo&druol.j. 553,571 (1994). 47. lohr, 518 u.s. at419. 48. horn, 376 f.3d at 167 (citing fda amicus curiae letter br. at 12). 49. 21 u.s.c. § 360j(g) (2005). 50. 21 u.s.c. § 360j(gx1) (2005). 51. 21 u.s.c. § 360j(&x2xa)(2005). 52. 21 u.s.c. § 360j(gx2xbxii) (2005). 53. oja, ill f.3d at 786. 54. 21 u.s.c. § 360k(axi) (2005) (fur the provision's specific language, see supra note 1). 2006] proper preemption or contrived construction? 241 of the land,"55 the supremacy clause provides that "state law that conflicts with federal law is 'without effect,"' an· idea clearly reflected by section 360k(a)'s prohibition of state requirements found to differ from, or add to, federal requirements. 56 secondly, created through a judicially recognized negative inference arising from the commerce clause's grant to congress of the power to regulate commerce "among the several states,"57 the dormant commerce clause prohibits states from passing any laws that may unduly burden or substantially interfere with interstate commerce. 58 thus, consideration for the dormant commerce clause is reflected by section 360k(a)'s "concern that interstate commerce not be unduly burdened by numerous and varying state requirements which differ from the federal government's requirements applicable to a medical device."59 therefore, although the statute's proper interpretation is unclear, the incorporation of section 360k( a) into the 1976 medical device amendments to the fdca was within the bounds of constitutionality. recognizing that the language of section 360k(a) leaves the section's proper interpretation in question, the fda attempted to alleviate some of the confusion by publishing 21 c.f.r. section 808.1(d), which provides the following: state or local requirements are preempted only when the food and drug administration has established specific counterpart regulations or there are other specific require­ ments applicable to a particular device under the act, thereby making any existing divergent state or local requirements applicable to the device different from, or in addition to, the specific food and drug administration requirements. there are other state or local requirements that affect devices that are not preempted . . . because they are not "requirements applicable to a device" within the meaning of section 52l(a) ... the act .... 60 the regulation goes on to include, inter alia, the following examples of state or local requirements that are not preempted, despite having the potential to affect medical devices: "(1) state or local requirements of general applic· ability where the purpose of the requirement relates either to other products 55. u.s. const. art. vi, cl. 2. 56. goodlin, 161 f.3d at 1370..71 (quoting cipollone v. liggett group, inc., 505 u.s. 504, 516 (1992)). 57. u.s. const. art. i,§ 8, cl. 3. 58. wabash, st. louis and pacific ry. co. v. illinois, 118 u.s. 557, 571 (1886). 59. haidak v. collagen corp., 67 f. supp. 2d 21,29-30 (d. mass. ct. 1999) (citing h.r. rep. no. 94-853 at 45 (1976)). 60. 21 c.f.r. § 808.l(d) (2005). 242 indiana health law review [vol. 3:231 in addition to devices . . . or to unfair trade practices in which the requirements are not limited to devices;" and "(2) state or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act."61 despite this clarification regulation, section 360k(a) has yet to be consistently interpreted. some courts have determined that it preempts general state common law tort suits, such as mrs. hom's, while others have concluded that it does not. ill. pre-horn decisions regarding the preemptive effect of section 360k(a) a. the supreme court of the united states: medtronic, inc. v. lohr in addition to the third circuit court of appeals, a number of federal courts across the country have weighed in on section 360k(a)'s preemptive effect, including the supreme court of the united states in the 1996 case of medtronic, inc. v. lohr. 62 in lohr, the court was faced with the task of determining whether section 360k( a) preempted state common law claims of negligence and strict liability against the manufacturer of a faulty pacemaker, approved by the fda through the streamlined section slo(k) process due to its substantial equivalency to another, previously.-approved pacemaker. 63 to aid the analysis, the court developed a two-pronged test. first, it had to determine whether there was a federal requirement "applicable to the device" in question. second, the court then had to ask whether a state requirement existed "with respect to" the device that was "different from, or in addition to" the federal requirement(s).64 upon applying this two-step inquiry, the court concluded, in a fractured 5-4 plurality decision,65 that lohr's common claims were not preempted by section 360k(a) as neither of the two requirements were met.66 writing for the court, justice stevens declared: 61. 21 c.f.r. § 808.l(d)(l-2) (2005). 62. medtronic, inc. v. lohr, 518 u.s. 470 (1996). 63. see id. (although the complaint was initially dismissed in the federal district court, the court of appeals reversed with regard to the negligent design claims before the case ultimately came before the supreme court). 64. lohr, 518 u.s. at 498-500 (cited in ojq, 111 f.3d at 788). 65. see, oja, 111 f.3d at 788 n.3 (the court's decision was delivered in seven parts, of which parts i, ii, iii, v, ,vii form the plurality opinion. for these five parts, justice stevens was joined by justices kennedy, souter, ginsburg, and breyer. for parts iv and vi, stevens was joined only by kennedy, souter, and ginsburg, while breyer wrote a separate opinion, concurring· in part. and concurring in the judgment. justice·o'connor filed an opinion concurring in part and dissenting in part, which was joined by justices scalia and thomas and chief justice rehnquist). 66. lohr, 518 u.s. at 500-01. 2006] proper preemption or contrned construction? although we do not believe that this [§ 360k(a) and 21 c.f.r. § 808.1(d)] statutory and regulatory language necessarily precludes "general" federal requirements from ever pre-empting state requirements, or "generar' state requirements from ever being pre-emptq<i. ... it is impossible to ignore its overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest. state requirements must be "with respect to" medical devices and "different from, or in addition to," federal requirements. state requirements must also relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device," and the regulations provide that state requirements of "general applicability" are not pre-empted except where they have ''the 'effect of establishing a substantive require­ ment for a specific device. , 67 243 although the court's holding clearly confirmed that section 360k( a) does not preempt state common law suits involving medical devices that have been approved through the section 51 o(k) process, the opinion was "fractured in an all but irreconcilable manner over the extent to which section 360k(a) would ever preempt a general state common law tort claim" involving a . medical device that was approved through the rigorous pma process. 68 nonetheless, the court's language in part v of the opinion hints that, in addition to preempting claims involving section 51 o(k)-approved devices, section 360k(a) also does not preempt state common law claims involving pma-approved medical devices. in that portion of its opinion, the court stated that "when congress enacted [section] 360k, it was primarily con­ cerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions. •>69 as it would be "rare indeed for a court hearing a common-law cause of action to issue a decree that has 'the effect of establishing a substantive requirement for a specific device."m section 360k(a) was not designed to preempt common law claims. moreover, when commenting on the proper interpretation of the word "requirement," as it is used in section 360k( a), stevens again hinted that section 360k(a) does not preempt general state common law claims involving pma-approved devices by stating that "its focus is device-specific enactments 67. /d. at 500 (quoting 21 u.s.c. § 360k(a) (2004) and 21 c.f.r. § 808.1(d) (1995)). 68. goodlin, 167 f.3d at 1371. 69. lohr, 518 u.s. at 489. later in his opinion, justice stevens expounds on this idea by stating that "[t]hese general obligations are no more a threat to federal requirem~ts than would be a state-law duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision ofa work force." /d. at 501-502. 70. ld. at 502-503 (citing 21 c.f.r. § 808.1(d)(6)(ii) (1995)). 244 indiana realm law review [vol. 3:231 of positive law by legislative or administrative bodies, not the application of general rules ofcommon law by judges and juries."71 in addition to justice stevens's plurality opinion, justice breyer's concurring opinion provided some insight into the court's stance on the boundaries of section 360k( a)'s preemptive reach. while opining that the pma process may "sometimes preempt a state-law tort suit,'m justice breyer illustrated his understanding of the issue by providing the following hypothetical aimed at conveying his conception of the statute's use of "requirement:" state x has a regulation requiring hearing aid wires to be one inch in length, but the federal, pma-imposedregulation specifies that hearing aid wires be two inches in length. as state x's regulation regarding the length of hearing aid wires represents an affirmative, substantive, device­ specific enactment, it should be preempted by the federal requirement pursuant to section 360k(a).13 thus, justice breyer opined that section 360k(a) should only work to preempt those state requirements that are specifically created for a particular fda-approved medical device.74 based on these portions of the lohr opinion, it is likely that, if given the opportunity, the supreme court would conclude that common law tort claims involving pma-approved devices survive section 360k(a)'s preemption language, just as it did with common law tort claims involving devices approved through the abbreviated section 51 o(k) process. in both cases, the common law state claims impose generally applicable duties, rather than the device-specific requirements that the court has decided section 360k(a) is aimed at preempting. b. circuit court decisions because the supreme court's decision inlohrwas primarily concerned with section 360k(a)'s preemptive effect on state claims involving medical devices approved via the speedy section 51 o(k) process, the circuit courts of appeals have been on their own to determine the extent of section 360k(a)'s preemptive reach with regard to state claims involving pma-approved devices, which has resulted in a confusing circuit split for example, a majority of the circuit courts, including the first, second, third, fifth, sixth, seventh, eighth, and ninth, have concluded that general state tort claims are preempted.75 these courts have generally determined that state common law 71. id at 489. 72. id at 503 (breyer, j., concurring). 73. id at 504. 74. id 75. see hom v. thoratec cotp, 376 f.3d 163 (3dcir. 2004) (involving a heart pump); martin v. medtrqnic, inc., 254 f.3d 573 (5th cir. 2001) (involving a pacemaker); brooks v. howmedica, inc., 273 f.3d 785 (8th cir. 2001) (involving bone cement); kemp v. medtronic, inc., 231 f.3d 216 (6th cir. 2000) (involving a pacemaker); martin v. teletronics pacing 2006] proper preemption or contrived construction? 245 claims should be preempted by section 360k(a) because they represent an attempt to impose requirements on medical devices that are different from, or in addition to, the federal, pma-imposed requirements. in arriving at this determination, these circuits have relied on the following two controversial assumptions: 1) the pma process imposes specific requirements on approved medical devices with which state requirements could conflict or add; and 2) general state common law tort claims impose specific requirements on fda approved medical devices that are different from, or in addition to, the federal pma requirements.76 on the other hand, the fourth, tenth, and eleventh circuit courts have concluded that state common law tort claims are preempted by section 360k(a), but for different reasons.77 for example, in a 1997 case involving a woman's negligent failure to warn claim, brought after she sustained injuries caused by a poorly manufactured prosthetic hip replacement system, the tenth circuit decided that the state common law claims were not preempted because they did not impose specific requirements on the device. 78 in reaching this conclusion, the court declared: [t]he duties imposed by [plaintiff's] negligent failure to warn claim do not constitute positive enactments of state law sufficient to constitute a state requirement developed ''with respect to" a medical device ... [g]eneral dut[ies ... are] ''not the kind[] of requirement[ s] []that congress and the fda feared would impede the ability of federal regulators to implement and enforce specific federal requirements."79 the eleventh circuit has arrived at a similar result via a different route, as evidenced by its 1999 decision in goodlin v. medtronic, inc. in that case, systems, inc., 105 f.3d 1090 (6th cir. 1997) (involving an implantable cardioverter­ defibrillator-demand pacemaker); mitchell v. collagen corp., 126 f.3d 902 (7th cir. 1997) (involving collagen-based injection treatments); papike v. tambrands inc., 107 f.3d 737 (9th cir. 1997)(involving tampons); talbott v. c.r. bard, inc., 63 f .3d25 (1st cir. 1995)(involving a heart catheter balloon); becker v. optical radiation corp., 66 f.3d 18 (2d cir. 1995) (involving an intraocular lens); michael v. shiley, inc., 46 f.3d 1316 (3d cir. i995)(involving a heart valve). 76. most likely, these assumptions are the courts' response to the following two-prong. inquiry suggested by the supreme court in lohr: i) is the f~ requirement "lij)plicable to the device" in question and 2) is the state requirement "with respect to" a medical device, and is it "different from, or in addition to," a federal requirement? lohr, 518 u.s. at 486 (quoting 21 u.s.c. § 360k (1995)). see also scandaglia & tully, supra note 33, at 257. 77. sanders v. optical radiation corp., no. 95-1967,1996u.s. app. lexis 18887 (4th cir. july 30, 1996) (involving an implantable intraocular lens); oja, 111 f.3d 782 (loth cir. 1997) (involving a prosthetic hip replacement system); goodlin, 167 f .3d 1367 (11th cir. 1999) (involving a pacemaker). 78. oja, 111 f.3d at 789. 79. id (quoting lohr, 518 u.s. at 501) (alterations in original). 246 indiana health law review [vol. 3:231 the court was asked to determine the preemptive effect of section 360k( a) on a woman's state common law tort claims of negligent design and strict product liability, brought after she underwent open-heart surgery to replace a pacemaker manufactured by the defendant the court focused on the pma process • lack of specificity by opining the following with regard to the term ''requirement:" "[w]ithin] section 360k, congress referred to a requirement as something a state or political subdivision could 'establish, • which appears to contemplate the state's creation of and, thus, ichmtification of some thing ... (the word] 'requirement' ... contemplate[s] the imposition of some identifiable precondition that applies to the device in question."80 accordingly, the court concluded that "the fda's approval of a medical device pursuant to the pma process, standing alone, imposes no specific federal requirement applicable to [the pacemaker] and, therefore, has no preemptive effect under section 360k(a) of the mda.'181 thus, the woman's state common law tort claims survived preemption. finally, in sanders v. optical radiation corp., the fourth circuit faced a situation in which the plaintiff brought state common law claims of negligence, strict liability, lack of informed consent, breach of warranty, and negligence per se after he was allegedly injured by defendant's implantable intraocular lenses. 82 the court concluded that the plaintiff's state common law claims were not preempted by section 360k(a), hinging its decision on the fact that, because the device was federally approved through the investigational device exemption ("ide"), no specific federal requirements had been imposed upon the device. with which a state requirement could possibly conflict. 83 the case was ultimately remanded to the district court for consideration consistent with the fourth circuit's conception of section 360k(a)'s preemptive reach.84 · · iv. inadequacy of the eleventh circuit's approach as previously suggested, the tenth and eleventh circuit approaches to interpreting section 360k(a) represent the two prevailing schools of thought among those who believe that state common law tort claims should not be preempted. nevertheless, although both interpretations reach a similarly desirable goal, the reasoning employed by the eleventh circuit in reaching that goal is difficult to accept. accorditig to the court, state common law claims should not be preempted because the supposed federal requirements, 80. goodlin, 167 f.3d at 1374. 81. jd. at 1382. for a more complete explanation of the reasoning behind the eleventh circuit's decision that the pma process does not impose specific requirements, see reiders, supra note 32 and part iv of this note. 82. sanders,l996 u.s. app. lexis 18887. 83. id. at *3-4. 84. id. at •s. 2006] proper preemption or contrived construction? 247 imposed through the pma process, are not requirements at all and, therefore, are incapable of conflicting with state-imposed requirements.85 neither the fda's review nor its approval via the pma process imposes any "ascertainable requirement" on a device. 86 in support of its opinion, the court added that, in the typical pma process review, the fda does not promulgate any "regulation, order, or any other statement of its substantive benchmark."87 the eleventh circuit is not alone in its opinion that the pma process does not impose specific requirements on devices with which state requirements could possibly conflict. for example, the federal district court of the district of columbia echoed the goodlin holding when it declared that, "[t]he fact that the pma process requires certain information and mandates certain procedures from manufacturers does not transform the· pma process itself into a specific federal requirement which triggers preemption and protects a manufacturer from suit. "88 moreover, a new york state appellate court held in sowell v. bausch & lomb, inc. that the pma process does not represent a specific federal requirement due to its failure to impose a specific standard on the optical device at issue.89 according to these courts, section 360k( a) does not stand in the way of state common law tort claims because the fda-approval process fails to impose specific requirements. although the preceding view pursues a desirable goal (non-preemption of state tort claims involving medical devices), the reasoning offered in arriving at that goal is problematic. as the typical pma process involves approximately 1,200 hours of review,90 "during which fda reviews the device's clinical data; preclinical test results; proposed labeling; components; and the methods, controls, and facilities used in the manufacturing and processing of the device, "91 it is difficult to accept the proposition that this process imposes no specific requirements on medical devices. on the contrary, the thoroughness of the pma review, coupled with the fda's ability to deny the pma application for failure to comply with agency regulations, demonstrates that the pma process inevitably leads to the imposition of specific requirements upon the device at issue. this view is supported by a number of courts, including the seventh circuit court of appeals, which, in quoting the supreme court of rhode island, noted that "the pma process 'involved a review of all the ingredients, components, manufacturing methods, and labeling to be used in conjunction with the [medical device]'" and is, 85. goodlin, 167 f.3d at 1382. 86. ld. at 1375. 87. id (cited by rieders, supra note 32, at 1192). 88. lakie v. smithkline beecham, 965 f. supp. 49,54 (d.c. 1997) (italics in original); see also webster, 171 f. supp. 2dat 11 (d.c. 200l)(explainingthat "even ifthe pmaprocess is much more rigorous, time-consuming, and expensive, this does not mean that the approval imposes 'specific requirements."'); rieders, supra note 32, at 1191-95. 89. sowell v. bausch & lomb, inc., 656 n.y.s. 2d 16,20 (n.y. app. div. 1997). 90. lohr, 518 u.s. at 477. 91. scandaglia and tully, supra note 33, at 257. 248 . indiana health law review [vol. 3:231 therefore, a "specific federal regulation. "92 the third circuit also maintains this view, which is demonstrated by its declaration in horn that "[t]here is no doubt that, as a practical reality, the pma process imposed requirements that were specifically applicable to the [device] ... . >m the court noted that this determination was informed by the pma process' imposition of''mandatory conditions" on the device, "created through ·a decades-long process of correspondence, clinical testing and device alteration-pertaining to the [device] • s manufacturing, packaging, storage, labeling, distribution and advertising."94 thus, in light of these considerations, it is difficult to dispute that the pma process imposes specific requirements on medical devices. accordingly, it is erroneous for courts, such as the eleventh circuit, to conclude that state tort claims are not preempted by section 360k(a) simply because the pma process does not impose specific federal requirements with which state requirements could possibly conflict. v. a call for the uniform adoption of the tenth orcuit's approach the present disagreement among the circuit courts regarding the proper interpretation of section 360k(a) needs to be resolved so that consumers who have been injured by medical devices may have clear notice regarding the extent of potential recourse available to them through state common ·taw claims. it is grossly unfair that a consumer who has been injured by a medical device in colorado (tenth circuit) may obtain a remedy from the device's manufacturer, while a consumer, such as mrs. horn, who has been injured by a medical device in pennsylvania (third circuit) is left empty handed. to resolve this inequity, all courts should follow the reasoning employed by judge fuentes and adopt the tenth circuit's approach that state common law tort claims involving medical devices are not preempted by section 360k(a) because they do not impose specific requirements that differ from, or add to, federally imposed requirements. as previously discussed, the tenth circuit arrived at this conclusion when it was given the task of determining whether section 360k(a) preempted a woman's state common law negligent failure to warn claim, brought after she sustained injuries caused by the defendant's cementless hip replacement 92. mitchell, 126f.3dat911 (quotingfryv.allerganmedicaloptics,695a.2d511 (r.i. 1997));seealsomartin,254f.3d573;kemp,231 f.3dat216;andscandagliaandtully,supra note 33, at 259258 (arguing that "in reviewing and approving the design, components, manufacturing process, and labeling of a device during the intensive pma process, [the] fda, through its approval or rejection of the device, is imposing specific requirements on that device related to each of those areas."). 93. horn, 376 f.3d at 170. 94. id (italics omitted). 2006] proper preemption or contrived construction? 249 system.95 following lohr 's two-pronged test, the court began its analysis by looking at the federal process by which the device was approved in order to determine whether it imposed specific requirements upon the device. this inquiry was quickly resolved in the affirmative due to the record's indication that the fda had, in fact, imposed a specific labeling requirement on the hip replacement system during its approval process. 96 the court then shifted its focus to the plaintiff's common law negligent failure to warn claim and asked whether it constituted a state requirement, developed with respect to the hip replacement system, which added to, or differed from, the specific federal labeling requirement.97 recognizing that the plaintiff's state common law claim was "predicated upon a general duty applicable to every manufacturer 'to inform users and purchasers of potentially dangerous items of the risks involved in their use, "'98 the court found the state claim to impose only a generally applicable requirement on the device, and thus resolved the second query in the negative.99 the state claim was not specifically developed with respect to the device in question and, therefore, should not be preempted by section 360k(a).100 in a particularly notable portion of its opinion, the court ensured the clarity of its decision with the following language: "the standard of care governing [plaintiff's] negligent failure to warn claim is not the type of device-specific requirement that would threaten ... federal interests."101 the tenth circuit has taken the correct approach in evaluating section 360k(a)'s preemptive effect on state common law tort claims. when a plaintiff brings a state common law tort claim alleging negligence in the manufacturing of a medical device, for example, their complaint will typically consist, inter alia, of the following four general elements: 1) the manufacturer had a general duty to use good care in manufacturing the device; 2) the manufacturer breached that duty; 3) the manufacturer's breach caused the 95. oja, 111 f.3d at 789. at this point, a brief discussion of the history of the fda's approval of the cementless hip replacement system is in order. initially, the device was approved by the fda through the expedited section 51 o(k) process when used with bone cement. soon thereafter, the manufacturer of the device submitted an ide application to the fda for use of the device without cement. the ide application was eventually approved, but not before the plaintiff was implanted with the device. (thus, the third circuit was mistaken in horn when, during its discussion of oja, it appeared to claim otherwise. see horn, 3 76 f .3d at 169, n.ll ). a few years after ide approval, the device manufacturer applied to the fda for permission to market the cementless device. the fda approved the application, classifying the device as class iii. one year later, the fda reclassified the cementless device as class ii. oja, 111 f .3d at 786-87. this information is peripheral to the present discussion, however, since the tenth circuit's decision against preemption hinged on the lack of specificity of the state common law tort claims, rather than on the specificity, or lack thereof, of the federal requirements. 96. oja, lll f.3d at 789. 91.id. .. 98. id (quoting medtronic, inc. v. lohr, 518 u.s. at 500). 99. id 100. id. 101. id (citing medtronic, inc. v. lohr, 518 u.s. at 500-01). 250 indiana healm law review [vol. 3:231 plaintiff's injuries; and 4) the plaintiff can demonstrate real injury.102 as one can plainly see, a claim of this nature merely involves the imposition of the general duty to use good care in manufacturing; it does not involve the imposition of a specific state "requirement," developed "with respect to" a medical device.103 thus, there is nothing that could possibly differ from, or add to, any federal requirement applicable to the device. this holds true for many state common law tort claims, which involve the imposition of the same kind of general duties. these claims involve a level of generality that should clearly remove them from the gambit of specific state requirements that section 360k(a) is aimed at preempting.104 · as judge fuentes wrote in his dissenting opinion in horn, claims such as negligence, strict liability, breach of warranty, and failure to warn are all general common-law tort claims that were not crafted specifically to govern medical devices, and so they are or they should be excepted from the scope of section 360k( a). 105 this conclusion is consistent with congressional intent and furthers public policy goals. a. congressional intent as justice stevens declared in part ill ofhis lohr opinion, "'the pwpose of congress is the ultimate touchstone' in every pre-emption case."106 therefore, a determination of the proper interpretation of section 360k(a) should begin with a close look at congressional intent when it passed this portion of the medical device amendments. did congress intend to shield an entire industry from responsibility for the injuries caused by faulty medical devices, or did it merely intend to prevent state legislatures from imposing substantive requirements on specific, federally approved medical devices? as it is unlikely that congress would have intended to shield an entire industry from liability, the only reasonable answer to this query is that, in passing section 360k(a), congress merely wanted to prevent states from imposing substantive requirements on specific medical devices that conflict with federally imposed requirements. indeed, justice stevens echoed this conclusion when he opined that it was unpersuasive and implausible to argue that congress would have intended to preclude "state courts from affording state consumers any protection from injuries resulting from a defective medical device. ''107 any conclusion to the contrary would "have the perverse 102. 57 a. am. jur. 2d negligence§ 71 (2005). 103. 21 u.s.c. § 360k(axi) (2005). 104. see lohr, 518 u.s. at 500 (supreme court opining that [21 c.f.r. § 808.1(d)] "provide[s] that state requirements of'general applicability' are not pre-empted except where they have 'the effect of establishing a substantive requirement for a specific device"'). 105. horn, 376 f.3d at 180 (fuentes. j., dissenting). 106. lohr, 518 u.s. at 485 (quoting retail clerks v. schermerhorn, 375 u.s. 96, 103 (1963)). 107. id. at 487. 2006] proper preemption or contrived construction? 251 effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of congress, needed more stringent regulation in order 'to provide for the safety and effectiveness of medical devices intended for human use. "'108 the legislative history of the mda supports this conclusion as "[t]here is ... nothing in the hearings, the committee reports, or the debates suggesting that any proponent of the legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of defective devices."109 there are a number of other clues suggesting that congress could not have intended section 360k(a) to have the broad preemptive effect embraced by a majority of the circuit courts. for example, in 1994, congress attempted to enact the product liability fairness act.110 this proposed act sought to create federal standards of product liability which, therefore, ''would have prevented private litigants from recovering punitive damages from the manufacturers of medical devices in cases where the ... device . . . was subject to pre-market approval. "'111 if congress had intended section 360k( a) to preclude all state cominon law claims, this bill probably would not have been proposed. indeed, the. eleventh circuit declared the following: [i]fthe 1976 congress truly had intended section 360k(a) of the mda to preempt all or most state law claims involving pma approved devices, then there would have been no need for the 1994 congress to include those ·devices in its proposed solution to the· more general travails of product liability law.112 other evidence that congress probably did not intend section 360k(a) to preempt all state tort claims involving medical devices exists in the fact that ''the first reported decisions on the industry's attempts to assert federal preemption of state product liability claims for devices subject to the fda's approval regimes did not appear until· 1991, fifteen years after congress passed the mda."113 according to the eleventh circuit, "it seems unlikely that the industry would have ignored its immunity under the mda for so long after the statute's enactment if congress, in fact, had intended to provide immunity in 1976."114 108. jd. (quoting 90 stat 539 (preamble tq act)). 109. id at 491. llo. s. 687, l03d cong. § 203 (1994)(cited in goodlin. 167 f.ld at 1379-80). ill. goodlin, 161 f.3d at 1380 (citing s. 687, 103d cong. § 203 (1994)). 112. jd. 113. jd at 1381 (citing slater v. optical radiation corp., 756 f. supp. 370 (n.d. lll. 1991)). 114. jd. at 1381. 252 indiana health law review [vol. 3:231 b. statutory construction the specific language that congress chose to include in section 360k( a) also supports the conclusion that congress probably did not intend to preempt all state common law tort claims involving federally-approved medical devices. specifically, congress used the word ''requirement," and chose to modify it with the phrase "with respect to a device."115 even at first blush, most readers would probably conclude that this particular word order conve~ the idea that congress was intending to preempt only those state requirements that were created specifically for (''with respect to") a particular device, rather than general requirements, such as good care in manufacturing, that are applicable to a host of devices. the fact that congress chose to place the words in this particular order suggests that the only requirements intended for . preemption are those which specifically relate to a particular device. justice stevens reflected this understanding when he declared in lohr that "requirement" is focused on device-specific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries. 116 elsewhere in his opinion, justice stevens again echoes this sentiment by describing the appropriate preemption situation as one involving a ''particular state requirement."117 this interpretation is also supported by justice breyer's aforementioned hearing aid wire hypothetical, in which he explains that preemption is only appropriate if the state requirement in question is as device-specific as the imposition of a mandatory length for hearing aid wires.118 in that example, the requirement is clearly developed ''with respect to" particular medical devices (hearing aids) and is deserving of preemption. . the general duties imposed by state common law tort claims do not fall within this category. thus, as state common law claims typically impose general duties of good care in manufacturing, they probably do not represent the affirmative imposition of substantive state law that congress intended to preempt when it chose the words "requirement'' and ''with respect to a device." the tenth circuit took this position when it observed that negligence principles do not constitute requirements developed '"with respect to' a medical device," and even went on to specifically state that the general duties imposed by negligence actions are "'not the kind [] of requirement[ s] [] that congress and the fda feared would impede the ability of federal regulators to implement and enforce specific federal requirements .... 119 moreover, it is lis. 21 u.s.c.s. § 360k(a)(2005). "[n]o state ... may establish or continue in effect with respect to a device intended for human use any requirement ••• .'') (emphasis added). 116. lohr, 518 u.s. at 490. 117. /d. at 500 (emphasis added). 118. /d at 504. 119. oja, 111 f.3d at 789 (quotinglohr, 518 u.s. at 501). 2006] proper preemption or contrived construction? 2s3 feasible to argue that even the fda entertained this view when it issued 21 c.f.r. section 808.1(d), entitled "exemptions from federal preemption of state and local medical device requirements." in that regulation, the agency states that section 360k( a) appropriately preempts "[s ]tate or local ... specific requirements applicable to a particular device," and then goes on to include the following example of what that phrase does not include: ''state or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices ... or to unfair trade practices in which the requirements are not limited to devices.''120 this language can easily be taken for the proposition that the general requirements imposed by state common law claims are not preempted by section 360k(a) because they are applicable in a number of situations to a number of different products, not simply in situations involving specific medical devices. the fda again revealed this understanding when it published 45 federal register 67,321. within this regulation, the fda discussed california's standard for prescription ophthalmic devices as an example of the type of state requirement . that is preempted by section 360k( a). 121 as california's prescription standard represented a very specific state requirement, it is reasonable to infer that the fda published this ruling, at least in part, to demonstrate that section 360k( a) is intended to preempt device-specific requirements, not the general requirements imposed by state common law claims. in addition to the ''requirement" and ''with respect to" language, congress also revealed its intent to avoid preemption of state common law tort claims through the use of the phrase "different from, or in addition to.''122 as the duties imposed through state common law tort claims typically seek to ensure good care and safety, it is difficult to comprehend how these actions could be "different from, or in addition to" federally-imposed requirements. in fact, this objective is entirely consistent with, rather than "different from, or in addition to," the purpose behind the federal requirements. just as state common law tort claims impose the duties of good care and safety, the goal of the federal requirements is to ensure the safety and effectiveness of medical devices intended for human use. accordingly, state common law tort claims should survive preemption because they are not "different from, or in addition to," the federally-imposed requirements. based on a close look at the language that congress chose to use in section 360k(a), courts should 120. 21 c.f.r. § 808.1(dx1) (2005). 121. medical devices; california application for exemption from federal preemption of state medical device requirements, 45 fed. reg. 67,321, 67,323 (oct. 10, 1980) (to be codified at 21 c.f.r. pt. 808). 122. 21 u.s.c. § 360k(ax1) (2005) ("[n]o state or political subdivision of a state may establish ... with respect to a device intended for human use any requirement-( i) which is different from, or in addition to, any requirement applicable under this chapter to the device .. .'') (emphasis added). 254 indiana health law review [vol. 3:231 interpret the statute to preempt only specific requirements created to apply to particular devices. c. presumption against federal preemption of state regulations the uniform adoption of the tenth circuit approach is also supported by the supreme court's observation that, when engaging in a preemption analysis such as the one at hand, courts must not only be guided by congressional intent, but must also understand that there is a presumption against federal preemption of a state regulation. 123 thus, even if state common law claims are deemed to impose some requirements upon medical devices, courts should be hesitant to conclude that they are federally preempted. indeed, "[p]reemption is disfavored in areas of historic importance to the states' police powers-areas such as public health and safety."124 as the state tort claims at issue seek redress for harm caused to health and safety, courts should maintain a presumption against federal preemption of such claims. d. public policy important policy considerations also support the view that state common law claims should not be preempted. as the purpose of the 1976 medical device amendments was "to provide for the safety and effectiveness of medical devices intended for human use,''125 the requirements imposed by the pma should be seen as the floor, not the ceiling. this is the precise reason why the third circuit's declaration in horn,. that any finding other than total preemption of all mrs. hom's state common law claims would "'stand' as an obstacle to the accomplishment and execution of the objective of the safety and effectiveness of the heartmate,"126 is counter-intuitive and unpersuasive. rather, a reasonable person would likely conclude that allowing mrs. hom to bring her state common law claims would serve as a positive contribution to accomplishing the pma process' objective of ensuring the safety and effectiveness ofthe heartmate.127 judge fuentes reflected this sentiment in 123. lohr, 518 u.s. at 484-85. 124. in rest. jude med., inc. silzone heart valves products liab. litig., no. 01-1396 (jrt/fln), 2004 u.s. dist. lexis 148 at*l6(d. minn. jan. 5,2004)(citingkemp, 231 f.3d at 222); see also scandaglia & tully, supra note 33, at 253 (explaining that "[i]n applying the preemption doctrine, courts assume that congress did not intend to displace the states' police powers, unless it is 'the clear and manifest purpose of congress' to accomplish this result.") (citinglohr, 518 u.s. 485 and jones v. rath packing co., 430 u.s. 519, 525 (1977)). 125. oja, ill f.3d at 786 (quoting pub. l. no. 94-295, 90 stat. 539 (1976)). 126. horn, 376 f.3d at 179 (quoting geier v. am. honda motor co., 529 u.s. 861, 873 (2000)). 127. see milkiewiczv. baxter healthcare corp., 963 f. supp.ll50, 1156-1157 (m.d. fla. 1996) (concluding that "state-law claims are not preempted under section 360k( a) to the extent that they seek to enforce requirements established by the fda as a result of the pma process."). 2006] proper preemption or contrned construction? 255 his dissenting opinion in horn stating: "i believe that allowing common-law liability would simply have the effect of encouraging [defendant] and other device manufacturers to go above and beyond fda standards, and this effect would clearly not contradict the mda 's purpose of enhancing medical device safety."128 otherwise, medical device manufacturers, such as thoratec corporation, are shielded from common law liability and, therefore, do not receive the requisite negative incentive to swiftly correct problems with their devices in order to make them safer and more effective. perhaps judge ferguson, of the ninth circuit court of appeals, put it best when he declared that .. [p ]remarket approval is supposed to benefit consumers, not create a rose garden, free from liability, for manufacturers."129 a final policy concern to consider is the cost-shifting effects that will result if section 360k(a) is held to preempt state common law actions against manufacturers of medical devices approved through the pma process. by shielding medical device manufacturers from liability, courts would merely be shifting the responsibility of paying the medical costs associated with the injuries caused by faulty medical devices to other entities, such as the injured parties themselves or insurance companies. while insurance companies may be able to bear this burden by raising their rates, individuals will typically be forced to incur substantial debt in order to pay their hospital bills. in its worst form, this unfortunate financial position could force individuals, who have likely suffered severe physical hardships, to sell their belongings or declare bankruptcy in order to satisfy their enormous debt. in addition to injured parties and insurance companies, doctors would be negatively affected if all state common law claims against medical device manufacturers were deemed preempted. once an injured individual realizes that he cannot recover from the manufacturer of the medical device that caused his injuries, it is likely that he will attempt to bring a malpractice action against the surgeon who implanted the device in an effort to simply recover some type of recompense for his injuries. this, in tum, will cause an unaffordable increase in many doctors' malpractice insurance rates. present malpractice insurance rates already cause a great number of doctors to forego careers as practicing physicians, and this problem will be exacerbated if injured parties cannot recover from medical device manufacturers. incidentally, it was high malpractice insurance rates that caused dr. benjamin sun, mr. hom's cardiothoracic surgeon, to leave private practice and join the faculty of a medical school located in another state. 130 128. hom, 376 f.3d at 180. 129. kennedyv. collagen corp., 67 f.3d at 1453, 1460 (9thcir. 1995), cert. denied, 518 u.s. 1033 (1996). 130. disappearing docs, politically active physicians association . . . home of the fighting docs, available at http://www.fightingdocs.com/main!disappearing_docs.html. (last visited march 9, 2005). 256 indiana health law review [vol. 3:231 in sum, the view that section 360k(a) preempts state common law tort claims contravenes congressional intent and disregards many important public policy considerations. accordingly, courts should uniformly adopt the tenth circuit's opinion that section 360k(a) only preempts state claims involving specific requirements developed for particular, federally-approved medical devices,. rather than·· general state tort claims that are applicable in many circumstances to any number of medical devices. vi. the third circuit's undue deference to 1he fda'samicus curiae brief in horn setting the topic of section 360k(a)'s proper interpretation aside, the focus of the following discussion will turn to evaluating the propriety, or lack thereof, of the third circuit's heavy reliance on the amicus curiae brief submitted by the fda in horn. admittedly, the court afforded an extremely high degree of deference to the fda's opinion in reaching its conclusion that mrs. hom's state common law tort claims were preempted by section 360k(a).131 signs of this substantial reliance are apparent throughout the · · court's opinion. for example, the court deferred to the fda's summary of mrs. hom's claims in footnote five, 132 detailed the fda's comparison of the section 51 o(k) and pma processes in footnote six, 133 and devoted two entire subsections to the fda's position in parts (l)(b) and (2)(b) of its opinion.134 forpurposesofthepresentdiscussion,themostconsequentialdeference the court made to the fda's position occurred in part (2)(b) of the opinion. here, the' court repeatedly .used the fda's amicus brief to support its conclusion that state common law tort suits impose specific requirements on a device that could potentially differ from, or add to, federally-imposed requirements. specifically, at the outset of this portion of its opinion, the court sets forth that "[t]he fda con.ceives ofhom's state common law claims as imposing a 'requirement' which is 'different' from that imposed by the fda in the pma process, and thus requiring preemption."135 · in the very next paragraph, the court again cites the fda's amicus brief, this time for the idea that state common law tort claims threaten the federal regulatory framework for medical devices because ''they encourage, and in fact require, lay judges and juries to second-guess the balancing of benefits and risks of a specific device to their intended patient population-the central 131. seehom,376f.3datl77(declaringthatits"preemptioncotlclusion[was]reinforced by the informed analysis found in the fda's amicus curiae brief:"}; see also id. at 182 n.29 (noting judge fuentes' observation that his "colleagiles seem to put great emphasis on the fda's amicus brief ... "). 132. hom, 376 f.3d at 166 n.5. 133. /d. at 167 n.6. 134. /d. at 170-72, 176-78. 135. /d. at 177. 2006] proper preemption or contrived construction? 257 role of fda-sometimes on behalf of a single individual or group of individuals."136 the court cites this unwillingness to allow judges and juries to second-guess the fda as one of its primary justifications for finding that mrs. hom's state claims were preempted.137 in affording such high deference to the opinions expressed by the agency in its amicus brief, the court placed inappropriate reliance on the agency's interpretation ofsection 360k(a). unfortunately, the court's fda-influenced decision created binding precedent within the third circuit, from which injured consumers, such as mrs. hom, will suffer the consequence of being left without a remedy from the entity most responsible for their injuries: the medical device manufacturers. as "[t]he court, not the agency, has 'final responsibility for the interpretation of the law• under which the regulation was issued,"138 the third circuit should have avoided this result. a number of federal courts have commented on the proper level of deference afforded to opinions expressed by agencies in amicus curiae briefs. the most notable qf these comments comes from the supreme court in its 1944 skidmore v. swift & co. opinion.139 there, the court bad the task of clarifying the degree of reliance properly placed on the opinions expressed in an agency administrator's amicus brief, regarding the proper interpretation of the fair labor standards act. recognizing that every such situation will entail a unique set of surrounding circumstances, the court outlined the following factors to be used in determining the proper amount of reliance: "the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give [the agency] power to persuade, iflackingpowerto control. "140 thus, the analysis is not the same in every situation. rather, courts must look to the circumstances surrounding the formation of the agency's opinion in order to properly evaluate the amount of weight it should be afforded. using the supreme court's skidmore opinion as a guidepost, many courts have offered their own comments on the proper amount of reliance that should be placed on the opinions expressed by agencies in amicus briefs. in yamaha corp. of am. v. state bd. of equalization, the california supreme court recognized that determining the proper amount ofweight to be given an agency interpretation is "fundamentally situational," requiring consideration of complex factors, such as the validity of the reasoning and consistency with 136. /d. at 178. 137. /d. 138. yamaha corp. of am. v. state bd. ofequalization, 960 p.2d 1036 n.4 (cal. 1998) (citing whitcomb hotel, inc. v. cal. emp. com., 151 p.2d 233,235 (cal 1944)). 139. skidmore v. swift & co., 323 u.s. 134 (1944). 140. /d. at 140; see also reich v. parker fire prot. dist., 992 f.2d 1023, 1026 (loth cir. 1993) (citing explicitly the slcidinore factors when asked to determine the proper amount of weighttobegiventoanagencyadministtator'sinterpretationoftbefairlaborstandardsact.). 258 indiana health law review [vol. 3:231 earlier pronouncements. 141 the court observed, however, that "[b ]ecause an interpretation is an agency's legal opinion, however 'expert,' rather than the exercise of a delegated legislative power to make law, it commands a commensurably lesser degree of judicial deference."142 from this, it becomes clear that, despite an agency's expertise, courts should only put limited reliance on agency interpretations. more recently, a new york district court discussed the proper amount of deference that· should be afforded to the central intelligence agency's ("cia") interpretation·· of the cia information act.143 recognizing that skidmore was the controlling authority, the court referred to the following list of factors, outlined by the second circuit, that should be used to inform the analysis: "the agency's expertise, the care it took in reaching its conclusions, the formality with which it promulgates its interpretations, the consistency of its views over time, and the ultimate persuasiveness of its arguments."144 despite finding these factors oflimited applicability due to a lack of available evidence, the court eventually afforded low deference to the cia's interpreta­ tion of the cia information act. 145 applying the skidmore factors, along with the supplemental considera­ tions suggested by yamaha and american civil liberties union v. dept. of def, one is led to question the third circuit's reliance on the interpretive opinions expressed by the fda in its amicus brief. understanding that this determination depends on the circumstances surrounding the formation ofthe fda's opinions, skidmore teaches that it is necessary to look at the thoroughness and validity of the fda's reasoning, the consistency of the fda's opinion with earlier pronouncements, and any other factors giving the fda the power to persuade. 146 although the fda appears to have been thorough in forming the opinions it expressed in its amicus brief, the validity of its reasoning is highly questionable. specifically, the agency claims that allowing state common law tort claims to proceed against manufacturers of medical devices "can harm the public health by retarding research and development and by encouraging 'defensive labeling' by manufacturers to avoid state liability .... " 147 this reasoning is unpersuasive and difficult to harmonize with the purposes of the mda. indeed, it is hard to comprehend how depriving injured consumers of their ability to obtain a remedy from the 141. yamaha corp. of am., 960 p.2d at 1037. 142. id. at 1036 (citingbodinson mfg. co. v. cal. employmentconun'n, 17 cal. 2d 321, 325-326) (cal. 1941)); see also u.s. v. mead corp., 533 u.s. 218, 228 (2001). 143. aclu v. dep't ofdef., 351 f. supp. 2d 265 (n.y. dist. ct 2005). 144. ld. at 269 (quoting cmty. health ctr. v. wilson-coker, 311 f.3d 132, 138 (2d cir. 2002)). 145. jd. at 278. 146. skidmore, 323 u.s. at 140. 147. fda amicus curiae letter br., at 26, hom v. thoratec corp., no. 02-4597 (3d cir. may 14, 2004}. 2006] proper preemption or contrived construction? 259 manufacturer of the device responsible for their injuries would work to "harm the public health."148 on the contrary, the public health would benefit from exposing manufacturers to tort liability for their injurious products in a number of respects. first, and most obviously, injured consumers would immediately benefit because they could receive compensation for their injuries. second, exposure to tort liability would give manufacturers the incentive to take greater care in developing safe and effective medical devices, which, in tum, would lead to a decrease in the number of people who suffer debilitating, and often fatal, injuries caused by poorly constructed devices. 149 one should not lose sight of the purpose underlying congress' creation of the 1976 medical device amendments: to ensure public health by enhancing the safety and effectiveness of medical devices. 150 allowing state common law tort claims is imperative to the accomplishment of this purpose­ only then can the fda's purported aversion to "harm[ing] the public health"151 be realized. in addition to lacking validity, the opinions expressed by the fda in its amicus brief are totally inconsistent with earlier pronouncements that the agency made on the topic of section 360k(a) preemption of state common law tort claims. in fact, in the 1998 supreme court case of smiths industries medical systems, inc. v. kemats, the fda filed an amicus brief expressing an entirely contrary opinion regarding section 360k(a)'s preemptive scope.152 there, the agency explicitly opposed arguments in favor of preemption by claiming that state common law suits are desirable because they help to ensure the safety and effectiveness of medical devices. 153 the fda expressed this same opinion when it published 21 c.f.r. section 808.l(d) in 1978, with amendments made thereto in 1980 and 1996. in particular, the fda wrote that preemption only applies to "specific requirements applicable to a 148. id. 149. see robert b. reich, a suitable remedy; when the fda is weak, wash. post, jan. 9, 2005, at b5 (commenting that "the tort system has at least one large virtue: it creates a powerful financial incentive for companies to ferret out potentially harmful side effects before they market their products, and to withdraw or redesign dangerous products if and when injuries occur."); blocking medical product suits, n.y. times, aug. l, 2004, at 410 ("it seems poor policy to assume that once the agency has judged a product safe enough to use, the manufacturer should be insulated forever from lawsuits that could force improvements."}. 150. med. device amendments ofl976, pub. l. no. 94-295,90 stat 539 (1976). 151. fda amicus br., supra note 147, at 26. 152. fda amicus curiae letter br., smiths indus. med. sys., inc. v. kernats, 522 u.s. 1044 (1998). 153. id.; see also kathleen kerr, liability lawsuits; can fda seal be broken?, newsday, aug. 11, 2004, at a26 (where the author includes the following 1997 quote by margaret jane porter, chief fda counsel during the clinton administration: "fda product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."). 260 indiana health law review [vol. 3:231 particular device,"154 noting that "state or local requirements of general applicability" do not fall within this category.155 the agency's current stance on the issue completely contradicts its earlier pronouncements inkernats and 21 c.f.r. section 808.l(d), and therefore, suffers under skidmore's consistencyrequirement.156 as consistency is the bedrock oflegal precedence, it should not be undermined by agency waffling. considering the invalidity and inconsistency of the fda's present position on the preemptive scope of section 360k(a), the third circuit should have been loath to defer to the opinions expressed by the fda in its amicus brief. as it was, however, the third circuit afforded great weight to the fda's opinion in reaching its ultimate conclusion that mrs. hom's state common law tort claims were preempted, thereby rendering its decision vulnerable to significant criticism. despite these arguments, the majority in horn justified its reliance on the fda's amicus briefby claiming that it was bound by the supreme court's holding in chevron, u.s.a. inc. v. nrdc. inc. to adopt the agency's interpretation. 157 under the well-known chevron analysis, a court is confronted with two questions when reviewing an agency's construction of a statute which it administers: first, the court must look to see if"congress has directly spoken to the precise question at issue."158 if congress has done so, and its intent is clear, the court and the agency must give effect thereto. 159 on the other hand, if congress has not directly addressed the issue, a court may not simply impose its own construction on the statute. rather, the court must give effect to the agency's interpretation, if it is reasonable.160 based on this framework, the horn court maintained that, since congress has not specifically addressed the statute's scope, it was bound to adopt the fda's reasonable interpretation of section 360k(a).161 the third circuit was mistaken when it determined 'that·the opinions expressed by the fda in its amicus brief were entitled to chevron deference. agency interpretations of particular statutes are only afforded chevron deference when "it appears that congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority. "162 while there is little doubt that the fda has rulemaking power, 154. 21 c.f.r. § 808.1(d) (2005). 155. 21 c.f.r. § 808.1(d)(l) (2005). 156. see good samaritan hosp. v. shalala, 508 u.s. 402, 417 (1993) (where the supreme court de<:lared that ''the consistency of an agency's position is a filctor in assessing the weight [its) position is due."). 157. chevron, u.s.a., inc. v. nat. res. def. council, inc., 467 u.s. 837 (1984). 158. id. at 842. 159. id. at 842-43. 160. id. at 843. 161. hom, 376 f.3d at 179. 162. mead corp., 533 u.s. at 226-27. 2006] proper preemption or contrived construction? 261 its current opinion on the preemptive scope of section 360k(a) was not "promulgated in the exercise of' its authority to make rules. 163 rather, the opinion was expressed in an amicus curiae brief, which courts such as the seventh circuit have expressly declared to be informal agency policy which is not entitled to chevron deference.164 accordingly, the third circuit should have applied a skidmore, rather than chevron, analysis to aid in determining the proper amount of weight to afford the opinions expressed by the fda in its amicus briefs. in failing to apply a skidmore analysis, the court placed an inappropriate amount of reliance on the fda's informal policy opinion and created precedent that falls short of furthering the medical device amendment's goal of protecting public health by ensuring the safety and effectiveness of medical devices precedent that is binding on all federal district courts within the third circuit. this effectively deprives injured consumers, such as mrs. hom, of the ability to recover a remedy from the medical device manufacturers responsible for the bann they have suffered. thus, the consequences of the third circuit's improper reliance on the fda's amicus brief are significant. the third circuit should not have afforded. so much weight to the fda's opinions, not only because doing so was out of line with applicable. judicial precedent, but also because of important public policy considerations. the fda is an administrative body, led by the secretary ofhealth and human services, tommy thompson. as mr. thompson's position makes him a member of the president's cabinet, he is an appointed official, subject to political influences. this fact is particularly relevant to the present discussion for the following reason: under the guise of promoting tort reform, the bush administration recently outlined plans for intervening in lawsuits involving state common law complaints against medical device manufacturers in order to persuade courts to adopt the view that such suits should be dismissed.16s this is a troubling development. as manufacturers of medical devices and pharmaceuticals contribute large sums of money to the bush administration, 166 their influence upon the administration's recent plans to block suits against 163. id at 227. 164. matzv. householdlnt'l taxreductionlnv. plan,265 f.3d 572, 574(7th cir. 2001); see also christensen v. harris county, 529 u.s. 576, 587 (2000) (where the supreme court stated: ''interpretations such as those in opinion letters -like interpretations contained in policy statements, agency manuals, and enforcement guidelines, all of which lack the force of law do not warrant chevron-style deference.j. 165. robert pear, in a shift, bush moves to block medical suits, n.y. times, july 25, 2004 (quoting new york democrat, rep. maurice hinchey, as declaring that "the administration had 'taken the f.d.a. in a radical new direction, seeking to protect dmg companies instead of the public. 'j; see also reich, supra note 149, at.b5 {''republicans who have been urging tort reform for years are in firm control of congress and the white house and are intent on . . . preempting lawsuits involving products already approved by regulatory agencies."). 166. fda prohibits consumer lawsuits for faulty pharmaceuticals, 1hink & ask. available at http://www.thinkandask.comlnewslfdadruglaw.html (last visited mar. 7, 2005). 262 indiana health law review [vol. 3:231 them is hard to deny. united states courts should not be subjected to this pressure. on the contrary, federal courts should be insulated from the country's political climate in order to achieve the just resolution of legal battles that society bas come to expect. the ability of injured consumers to recover for injuries caused by faulty medical devices should not lay victim to the oppressive sword of wealthy special interest groups. vii. conclusion to resolve the present debate, as well as to avoid undue deference by courts to the fda's wavering opinion, courts need to ultimately decide upon one consistent interpretation of section 360k(a). an efficient method for achieving this would be for the supreme court to revisit the issue and clarify its fractured opinion in lohr. while the supreme court's opinion was clear that section 360k(a) does not preempt state common law claims when the device in question bas been approved through the expedited section 51 ok substantial equivalency process, it was vague with regard to section 360k( a)'s preemptive effect on state claims when the device bas been approved through the rigorous pma process. therefore, the court needs to address the issue within the context of a pma-approved device and clarify its stance. as a superior alternative, this debate should be settled by congress. recognizing the abundant confusion caused by the language of section 360k( a) as it is presently written, congress could either amend the preemption provision of the mda to specifically address the statute's effect on state tort claims, or it could encourage the fda to issue another clarification regulation. regardless of the method by which a remedy occurs, courts across the country need to adopt a uniform interpretation of section 360k(a), preferably one that recognizes the continued vitality of state common law tort claims involving federally approved medical devices. the language of section 360k(a) declares that states cannot impose requirements ''with respect to a device" that are different from, or in addition to, the federally imposed pma requirements for the device. therefore, preemption should only be appropriate if the state imposes a specific requirement on a particular, pma­ approved device. conversely, preemption is not appropriate if the state is merely imposing a generalized duty of care on the device manufacturer through a common law tort action. it would seem that this is the proper interpretation of section 360k(a) and, consequently, the view that all courts should embrace. indiana iieaith law review volume4 2007 issue 1 articles obesity, public health, and the food supply barbara l. atwell no fault, no worries ... combining a no-fault jeremy coylewright medical malpractice act with a national single-payer health insurance plan reforming fda policy for pediatric testing: joanna k. sax challenges and cht:mges in the wake of studies using antidepressant drugs notes policy. plain language, and legislative purpose: lauren n. grattenthaler applying state medical malpractice caps on damages to federal emtala claims do the benefits outweigh the risks? the legal, neil f. hazaray business, and ethical ramifzcations of pulling a blockbuster drug off the market the patient safoty and quality improvement leigh ann lauth act of 2005: an invitation for sham peer review in the health care setting nonprofit hospital billing of uninsured patients: david l. nie consumer based class actions mljve to state courts indiana university school of law indianapolis iupui indiana health law review volume4 edjtdr-bt-chkf lauren n. grattenthaler 2006-2007 executive mtuulging e4itor rachel a. scherer executive notes edltdr christopher campaniolo executive productjon edjtdr russell b. cate executin articles edjtdrs raegan m. gibson brandt r. voight executive business editor colleen m. powers note development editors carty s. everett angela k. grogan shannon n. jamison danielle l. kaiser scott j. smith heather a. barnes jacob v. bradley louis j. britton keith a. butler robert w. cochrane matthew v. daley matthews. dionne mark e. douglas robin e. ebert robert r. elder manjugoel emmal.haw michael j. kyle articlesedltdrs brent r. borg shalla m. collier bernice v. conway neil f. hazaray davidl.nie fiicu/tyadvisors lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz associllte editors lynn m. eriks chelynne l. harris adam hollander-urbach kimberly a. kessinger billi j. lycett brendan w. miller clayton r. portell matthew l. rea blake c. reed erin m. saylor thiru sethuraman jonathan d. stowers john p. taylor kyra r. wagoner amy waltz jessica d. williams indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2006-07 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university school of lawindianapolis. subscriptions. the current subscription rate is $20.00 for two issues (domestic mailing). unless the business office receives notice to the contrary, all subscriptions will be renewed 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indiana university school of law-indianapolis. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia university. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university ofcoloq1do school of law. , harold greenberg, professor of law'enieritus. ab., teinple university; j.d., university . of pennsylvania law school. wiluam f. harvey, carl m. gray professor of law & advocacy emeritus. a.b., . university ofmissouri; j.d., il.m., harvard law school. · w. wiluam hodes, professor of law emeritus. a.b., harvard college; j.d., rutgers university school of lawnewark. wiluam e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern lllinois university; ll.b., university ofdlinois college of law. kenneth m. stroud, professor of law emeritus. a.b., jd., indiana university­ bloomington. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., il.m., george washington university school of law. law library faculty juorm: ford anspach; professor of law mid director, ruth lilly law library. b.s., ml.s., kent state university; j.d., mississippi couege school of law. dragomir cosanici, head of reference. b.a., michigan state university; m.i.l.s., university of michigan; j.d., university of kansas. debra denslaw, reference librarian. b.a., franklin college; m.s., university ofdlinois urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior couege; b.a., georgia southwestern college; ml.s., university of kentucky. wendeij.. johnting, assistant director for technical services, a.b., taylor university; m.l.s. indiana university. chris b. long, catalog librarian. b.a., m.a., m.l.s., indiana university. mahnaz moshfegh, serials/acquisitions librarians, b.a., national university of iran; m.s., tehran university; ml.s., ph.d., indiana university. mariam a. murphey, associate director, ruth liuy law library. b.a., purdue university; jd., m.l.s., indiana universitybloomington. kiyoshi orsu, computer system specialist. a.a., parkland college; a.b., m.s., c.a.s., university of lllinois. indiana health law review volume4 issuel table of contents· articles obesity, public health, and the food supply ........... barbara l. atwell 1 no fault, no worries ... combining a no-fault medical malpractice act with a national single-payer health insurance plan .................................... .jeremy coylewright 29 reforming fda policy for pediatric testing: challenges and changes in the wake of studies using antidepressant drugs ............................................... joanna k. sax 59 notes policy, plain language, and legislative purpose: applying state medical malpractice caps on damages to federal emtala claims ...................................................... lauren n. grattenthaler 85 do the benefits outweigh the risks? the legal, business, and ethical ramifications of pulling a blockbuster drug off the market ................................................................... neil f. hazaray 115 the patient safety and quality improvement act of2005: an invitation for sham peer review in the health care setting .......................................................... leigh ann lauth 151 nonprofit hospital billing of uninsured patients: consumer based class actions move to state courts ................. david l. nie 173 2007 understanding the disparity in av all.ability of prescription drugs in the united states: compromise may be the answer natalie j. tanner• introduction the issue of pharmaceutical drug affordability has moved to the fore­ front of political and public health concerns over the past decade. the increas­ ing prices of prescription drugs in the united states have denied a class of people access to medication. this problem is not limited to the united states; similar and often more acute dilemmas can be seen in many developing countries. the high prices of pharmaceuticals in the united states can be attributed to several factors. the two most prevalent are the tempqrary monopolies large pharmaceutical companies gain upon receiving patents for their products, and the stringent standards which those drugs must meet under food and drug administration (fda) regulation.• the monopoiies granted to the patenting companies are not without justification because those companies must invest millions of dollars in research and development (r&d) of these new drugs.2 the patent monopolies act to fulfill the companies' investment-backed • j.d. candidate, 2005, indiana university school of law-indianapolis; b.s. in biomedical science, 2002, texas a&m university, college station, telaj. i would like to give a special thanks to my family, professor william bradford, and professor richard wright for all of their much appreciated advice and support. 1. see mark b. mcclellan, commissioner, food & drug administration, speech at the fifth annual david a. winston lecture (oct. 20, 2003) [hereinafter mcclellan fda speech], available at http:/lwww.fda.gov/oc/speechesl20031winston1020.html. 2. see michele l. creech, comment, make a run for the border: why the united states government is looking to the intenu:ztional markel for affordable prescription drugs, ls emory int'l l. rev. 593, 600-04 (2001) (indicating that patents are granted to originator products to allow developers to recoup r&d expenies); see also robert lenzner, the effects could be devastating, forbes, nov. 27, 2000, at 156. but cf. lawrence a. sullivan, antitrust: new economy, new regime second annual symposium of the american antitrust institute: is competition policy possible in high tech markets?: an inquiry into antitrust, intellectual property and broadband regulation as applied to "the new economy," 52 case w. res. l. rev. 41,63 (2001)(arguingthatr&d grantscannotcontinuetorisepercompanywithoutan accompanying oppressive effect on· competition in that· madc.et). see generally pharmaceutical research& mfg. of am., why do prescr1ptiondrugsc0st so much? .•• and other questions about your medicines (2000) [hereinafter questions about medicines] (explaining the different factors affecting the rising costs ofpbatmaceutical drugs), available athttp:/lwww.phrma.<q'publicationslpublicatiooslbroc:hure/questionslquestions.pdf. 268 indiana health law review [vol. 2:267 expectations and create incentives for the companies to continue their costly research in pursuit of new and improved phannaceuticals.3 the general rule of law is that patents do not extend extraterritorially; therefore, countries around the world have the capability to set up their own patent. requirements. 4 this creates divergent international standards, which breed, among other difficulties, many patent infringement issues. this is especially relevant to large pharmaceutical companies with global markets. 5 · in addition to the differing patent standards among countries, the intan­ gible nature of patent rights makes them especially difficult to protect from infringement.6 while large amounts of time and money must be devoted towards developing the initial chemical structure of a drug, once it has been detennined, it is much easier and less expensive to produce the actual drug product. 7 anyone who did not invest their resources in the costly research and development process could easily replicate that chemical structure through inexpensive methods, such as reverse engineering, bypassing all of the neces­ sary r&d costs. 8 in the united states, the high cost of pharmaceutical drugs has led to an increasing number of people turning to foreign phannaceutical manufacturers, commonly in mexico and canada, where cheaper, generic versions of the medication they need are available.9 the manufacturers in these foreign com­ panies are able to sell these drugs cheaper than the united states companies because they do not have the r&d overhead to recoup.10 these drugs are also 3. creech, supra note 2, at 600; see also christopher scott harrison. comment. protection ofpharmaceuticals as foreign policy: the canada-united states trade agreement and bill c-22 versus thenorthamerican free trade agreement and bill c-9 1, 26 n.c.j. int'l l. & com. reo. 457 (2001 ). but cf. sullivan. supra note 2, at 63 (asserting competition will. eventually be suppressed if r&d grants continue to grow per company). 4. paper converting mach. co. v. magna-graphics corp., 745 f.2d 11, 17 (fed. cir. 1984). 5. harrison, supra note 3, at 466-67. 6. /d. at 463. 7. /d. at494. 8. id at 493-94. 9. mcclellan fda speech, supra note 1; robert pear, lawmakers are negotiating import of prescription drugs, n.y. times, oct. 31, 2003, at a14. the internet has greatly increased the american consumer's ability to reach foreign pharmaceutical manufacturers. while this note acknowledges that prescription and non-prescription drugs are imported into the united states from all over the world, the scope of this note will focus mainly on prescription drugs from canada. in addition, any reference made to "foreign pharmaceuticals" or "foreign drugs" also includes american-made drugs sold in canada by the authorized patent holder and subsequently re-imported into the united states, unless otherwise specified. 10; see bruce a lehman, intellectual property under the clinton administration, 21 geo. wash. j.int'l l. & econ. 395, 395 (1994) ("other nations often look for a free ride, seeking to build their economies not by encouraging the innovation and creativity of their own people through strong protection for all forms of intellectual property, but by promoting intellectual property piracy through weak. laws or no protection at all.''). 2005] the disparity in av ailabh.jty of prescription drugs 269 less regulated, 11 and some can be purchased without a prescription. 12 in addi­ tion to these safety issues, their use in the united states presents a question as to patent infringement the escalating prices of pharmaceuticals in the united states have created an incentive for state governments to seek and even subsidize foreign pharmaceutical companies in order to provide lower priced pharmaceuticals to united states citizens who cannot afford the high prices in the united states. this creates several legal questions concerning whether a state, or even the federal government, could subsidize these foreign companies without violating existing united states law. this question consists of several issues, including whether this should be considered either a patent infringement under the united states patent code or a "taking'' under the fifth amendment of the united states constitution. moreover, if such governmental subsidies of foreign drug makers. are considered an infringement or a taking, the law is not clear as to how or by whom the patent-holding companies should be compen­ sated. this is a novel issue and has not yet been ruled upon by the united states supreme court. this note will focus on the different interests asso­ ciated with the increasing problem of high cost pharmaceuticals and propose a resolution based on the notion of compromise. pharmaceutical pricing in the united states is a complex topic and one in which numerous parties have considerable interests involved. in addition, each of these groups influences the situation in their own individual way. parts i, ii, and iii of this note will assess the problem-who the affected parties are, the pharmaceutical industry's justification for their high prices, and the gravity of the situation that has evolved. secondly, this note will provide an overview of the evolution of canadian patent law and the importation of canadian drugs into the united states. partv then evaluates the united states law applicable to the pharmaceutical drug importation issue. the conclusion outlines the proposals for action at the federal level, which entail a compre­ hensive structuring of a new. system aimed 8olely at the prescription drug industry. 11. gardiner harris & monica davey, u.s. steps up effort against druglmports, n.y. times,jan.24,2004,atc1;bemardsimon,canadaresistsu.s;pressureondrugsales,n.y. times, nov. 20,2003, at c9. . 12. william k.. hubbard. senior associate commissioner for policy, planning and legislation, food & drug administration. statement befoi'tl the subcom.on health, comm. on energy & commerce (july 25, 2002), available at http://www.fda.gov/ola/20021 drugimportation0725.html; blanchard randall iv & donna u. vogt, cong. res. serv., importing prescription drugs crs-2 (aug. 22, 2002), available at http://www.law .umaryland.edulmarshall/electomicresouices/crsreports/crsdocuments/ rl31503.pdf. 270 indiana heal1h law review i. parties affected by the increased prices of pharmaceutical drugs a. the elderly, impoverished, and uninsured [vol. 2:267 while american pharmaceutical consumers in general pay more for prescription drugs than citizens in other developed countries, 13 the united sui.tes' elderly and uninsured bear the heaviest burdens. the·problem of affordability has become exceptionally severe for older people who are unable to manage their finances when they become ill.14 while prescription drugs represent a relatively small part of total consumer household spending on average, 15 this amount increases significantly with age.16 several factors are responsible for this trend, for instance, that the elderly are living longer17 and sixty-five to seventy-five year old demographic has a low median income.18 the poor are an additional class faced with the predicament of phar­ maceutical drug affordability. in 1999, approximately 42.6 million people in the united states had no health insurance coverage whatsoever.19 without health insurance coverage, consumers are forced to pay for prescription drugs out-of-pocket, a next to impossible feat for many.20 a 2001 survey revealed that noncompliance with prescribed medication in order to save money is much higher with people in low income groups. 21 thus, when faced with the 13. merrill goomer, the price isn't right, am. prospect, sept. 11, 2000, at 25. 14. broderick perkins, high cost of pharmaceutical, deadunenbws.com, mar. 22, 2002, at http://www.deadlinenews.com/drugcosts32902.html (last visited apr. 17, 2005) (on file with the indiana health law review). 15. kaiser family foundation, prbscription drug 'i'rbnd-a chartbook update 25, ex. 11 (nov. 2001 ), available at http://www.ldlorglrxdrugslloader.cfm?url=/commonspot/ security/getfile.cfm&pageid=13796. 16. bureau of labor statistics, u.s. dbp't of labor, consumer expenditure survey tbl. 47 (2002), available at http://www.bls.gov/cex/2002/sharelage.pd£ in 2002, the average consumer spending on drugs was 1.2% of their annual expenditures. id. however, individuals sixty-five and above spent 3.4% of their annual consumer expenditures on drugs, while the seventy-five years plus demographic increased their drug expenditures even more to 4.3% of their annual consumer spending. id 17. stephen r. latham, an overview and analysis of legal and policy responses by the states, 24 j. lbgalmed. 141, 143 (2003). 18. robert l. bartley, thinking things over: drug prices: a much-needed primer, wail st. j., july 22,2002, at a15. 19. geri aston, individual mar/ret tough for many insurance buyers, am. mbd. news, july 9/16, 2001, at 14; randall r. bovbjerg & frank c. uuman, health insurance and health access, 22 j. legalmed. 247,247 (2001). 20. stuart 0. schweitzer, pharmaceutical economics and policy 93-97 (1997). 21. out-of-pocket costs are a substantial barrier to prescription drug compliance, health care news (harrislnteractive inc., rochester, n.y.), nov. 20, 2001, at 2 [hereinafter out-of-poe/ret costs], available at http://www.harrisinteractive.com/news/newsletters/ healthnews!hi_healthcarenews2001voll_iss32.pdf(onfilewithlndianahealthlawreview). this survey focused on noncompliance due to high co-payments; however, the overall finding of noncompliance with prescription medication due to high prices can be applied to the uninsured as well. 2005] the disparity in av ailabh.jty of prescription drugs 271 choice of following a prescribed drug regime versus employing money for other needs, survey results indicate that noncompliance with th~ prescribed medication is common. a similar inclination is seen in the elderly.22 serious health.consequences often result when chronic diseases, prevalent in the aged population, are not treated according to the prescribed dosage. 23 b. united states federal health care programs providing an avenue through which health care can be made available to all americans has been a policy concern for several decades. the united states government established two national health insurance programs in 1965 in order to assist elderly and impoverished americans to gain access to health care. 24 medicare covers the elderly, persons with certain qualifying dis­ abilitie~. and people with end-stage renal disease,25 while medicaid acts to make health care available to the poor,26 a class defined differently :from state to state. due to the states • ability to adopt independent need-based standards. 27 when these federal insurance programs were instituted, they did not cover outpatient prescription drugs as part of the mandated benefits package.28 this has become increasingly problematic, especially among the aged population, as modem health care is relying more and more heavily on drug therapy.29 the increasing price of phannaceutical drugs has only further exacerbated the situation. 22. kaiser family found., prescrlptjon druo trends (2004), available at http://www!df..orglrxdrugs/loader.cfin?url=/commonspot/security/getfile.cftn&pageid=48305. 23. out-of-pocket costs, supra note 21. 24. john holahan, financing healtii care for thb poor 1 (1975); ctrs. for medicare & medicaid servs., medicare infonnation resource, at http://www.cms.hhs.gov/ medicare/default.asp (last modified feb. 9, 2005) (on file with the indiana health law review). 25. ctrs. for medicare & medicaid servs., medicare information resource, at http://www.cms.hhs.gov/medicare/defiwlt.asp (last modified feb. 9, 2005) (on file with the indiana health law review). 26. michaels. sparer,medicaidandthblimitsofstatehealtiireform 8 (1996); alexander above, jr.,.the medicaid planning handbook 6 (1992). "[t]he medicaid program is need based. providing benefits only to those patients who demonstrate a financial need .... " ld. 27. conrad j. barrington, note and comment, pharmaceutical research and manu­ facturers of america v. concannon and maine's prescription drug rebate statute: a twenty­ first century solution to the medicaid crisis, 23 whi'itier.l. rev. 1127, 1152 (2002); bove, supra note 26, at 6; holahan, supra note 24; at 3. notably, states were allowed to set their own eligibility standards for their medicaid program; they were to provide their own definition for the term "medically needy." jd. 28. michaele.gluck.nat'lacad.ofsoc.ins.,medicarebrlefno.l,amedicare prescrlptjon druo benefit (apr. 1999), available at http://www.nasi.org/usr_:doc/ medicare_ brief_l.pdf. 29. see earl p. steinberg et al., beyond survey data: a claims-based analysis of drug use and spending by the elderly, health aff., mar.-apr. 2000, at 198, 199; see also sharon levine et al., kaiser permanente 's prescription drug benefit, heal til aff., mar.-apr. 2000, at 185. 272 indiana health law review [vol. 2:267 in response to the bilateral problems of controlling drug prices and pro­ viding adequate coverage, congress recently reformed medicare's prescription drug policy to provide prescription drug benefits to some medicare reci­ pients. 30 · under this plan, which is scheduled to be fully implemented by january of2006, low-income medicare beneficiaries, including those who also receive medicaid coverage in addition to medicare, would receive additional coverage of their self-administered prescription drug costs.31 critics of the reform state it does not provide the types of benefits seniors need and comes with a large price tag in a time of an already significant government deficit32 while this program will assist the elderly in paying the high prices of prescription drugs, it does not provide similar benefits for the poor. "although some prescription drug benefits are available through medicaid, the federal mandate does not require such coverage .• m despite the growing amounts of both state and federal funds provided to the medicaid program and the millions of citizens who have received aid, significant numbers of the populace are excluded from coverage. 34 because of the differences among state eligibility requirements, a significant number of individuals who fall below the federal poverty level do not receive aid from medicaid, and are unable to meet their prescription drug needs. 35 even if an individual is eligible for the medicaid program, there are significant disparities in payments among states.36 thus, a medicaid recipient's status may depend upon the state in which he or she resides. however, amidst this environment of rising costs, state governments are not necessarily acting unreasonably by enforcing limited medicaid eligibility 30. medicare prescription drug, improvement, and modernization act of2003, pub. l. no. i 08-173, 117 stat. 2066 (2003). 31. kaiser family found., medicare drug benefit calculator: notes and resources, at http://www.kff.org/medicare/rxdrugscalculator.ciin (revised apr. 14, 2004) (on file with the indiana health law review). 32. bush signs medicare bill, cbsnews.com, dec. 8, 2003, at http://www.cbsnews.com/stories/2003/10123/politics/mains7964s.shtml (last visited apr. 17, 2005) (on file with the indiana health law review). 33. see ctrs. for medicare & medicaid servs., medicare information resource, at http://www.cms.hhs.gov/medicare/default.asp (last modified feb. 9, 2005) (on file with the indiana health law review) (listing the certain services that must be offered to the categori­ cally needy population in any state program). however, the federal government has provided an incentive for states to include optional services such as prescription drug coverage under their state medicaid plans by offering additional federal funding if such a service is elected. /d. 34. sparer, supra note 26, at 8; frank j. thompson, the faces of devolution, in medicaid and devowtion a view from 1he states 16-17 (frank j. thompson & john j. dilullo, jr., eds., 1998). 35. stephen b. soumerai & dennis ross-degnan, inadequate prescription drug­ coverage for medicare enrollees-a call to action, 340 new eng. j. med. 722, 722-23 (1999); thompson, supra note 34, at 16. 36. thomas w. grannemann & mark v. pauly, controwno medicaid costs: federausm, competmon, and choice 23 (1983). 2005] the disparity in av ab..ability of prescription drugs 273 requirements and restricted optional coverage plans.37 states do not operate with unlimited funds and society is not often receptive to large tax increases. one possible solution to the disparate coverage problem may be to remove prescription drug benefits entirely from medicare and medicaid and vest all prescription drug authority in one comprehensive federal program that eli­ minates the states' discretion in defining need. while such a system would not eliminate the need for tax funding, it would allow the cost of the program to be spread more evenly across the nation. ii. factors contributing to the increased costs of pharmaceuticals in the united states the united states drug industry operates using free market pricing, but american drug prices are the highest in the world38 although much less than half of the prescription drug use worldwide can be attributed to americans, americans account for approximately half of the revenue of prescription drugs globally. 39 there are several different factors contributing to this discrepancy. primarily, governments of industrialized nations, excluding the united states, impose price controls in order to keep the prices of pharmaceuticals low.40 by doing so, such governments decrease the value of the patents to their holders by limiting potential profit contrary to this majority system, "[t]he united states remains one of the only industrialized nations whose government has not imposed restrictions on pharmaceutical pricing.'o41 due to free market pricing in the united states, there is little structural limitation on the amount drug manufacturers can charge for prescription drugs, save for the narrow controls enforced by health maintenance organizations (hmos), pharmacy benefit mangers (pbms), and government funded programs (medicaid and medicare). 42 critics view this as a sacrifice of the united states public health by the government supporting patent holder profits.43 37. barrington, supra note 27, at 1153. 38. tony pugh, new senate bill to allow he-importation of u.s.-made drugs from canada, knight ridder washington bureau, oct 30, 2003. 39. mcclellan fda speech, supra note 1. 40. talk of the nation: analysis: obstacles to reimporting prescription drugs from abroad as a way to lower pharmaceutical drug prices in the united states (npr radio broadcast, jan. 2, 2001) [hereinafter npr broadcast] (quoting juan williams). 41. jerry stanton, comment, lesson for the united states from foreign price controls on pharmaceuticals, 16 conn. j.int'll. 149, 155 (2000). 42. robert j.a. basilio, jr., the battle for the people's health and wallets, business world, jan. 5, 2001, at 25. 43. letter from ralph nader and james love to tommy thompson, secretary, dhhs (oct. 18, 2001), at http://www.cptech.orgftplhealth/cl/cipro/nadethom1018200l.html (last visited apr. 17, 2005) (on file with the indiana health law review). but see david olive, it's a sad sight to see ottawa ready to give in to bayer on drug, toronfo star, oct. 23,2001, ate03. 274 indiana health law review [vol. 2:267 several other factors contribute to the elevated costs of pharmaceuticals in the united states besides the strength attributed to patent holders' rights. an . escalation in the number of prescriptions, including unwarranted or improper drugs, which add to demand, is one such alternative source.44 like­ wise, a general increase in drug prescriptions is contributing to the increase in the costs of such drugs.45 in addition, in the modern medical community there has been an increasing trend towards alternative means of treatment; namely, the substitution of prescription drugs in the place of medical procedures.46 additionally; the united states requires all new drugs to obtain fda approval prior to their placement in the market. the fda's center for drug evaluation and research (cder) was created to assure that all prescription and over-the-counter drugs are safe and effective; essentially, that the drug's benefits to society outweigh its potential risks. 47 after the cder determines a new drug is safe for consumer use, it continues to serve as a "consumer watchdog for the more than 10,000 drugs on the market to be sure they con­ tinue to meet the highest standards.'>48 because the united states pharma­ ceutical companies must also satisfy the prerequisite of fda approval to bring their new drugs to market, their expenses are increased all the more. another key contributing factor to the high price of pharmaceutical drugs in the united states is direct-to-consumer (dtc) advertising. over the past decade, pharmaceutical companies have steadily increased their budgets for marketing, advertising and public relations.49 accompanying the addi­ tional marketing expenses that pharmaceutical companies must account for in their drug pricing, dtc advertising has improved consumer awareness and placed . pressure on physicians to prescribe the medications consumers request. so advertising increases the costs consumers must cover when paying for their drugs and promotes the shift of the medical field from a service to a business. such a shift naturally promotes the pharmaceutical company's attempt to maximize profits, therefore increasing product prices in accordance with increased demand. in addition, consumer demand is relatively inelastic in relation to the price of prescription drugs because such drugs are often necessary to the 44. mark h. beers et al., inappropriate medication prescribing in skilled-nursing facilities, 117 annals internalmed. 684 (1992). 45. id 46. questions about medicines, supra note 2. 47. dep'tofhealth&humanservs.,food&drugadmin.,pub.no.fs01-3,just the facts improving pubuc health: promoting safe and effective drug use (aug. 2003) [hereinafter improving pubuc health], available at http://www.fda.gov/opacom/ factsheets/justthefilcts/3cder.pdt; michelle meadows, the fda 's drug review process: ensuring drugs are safe and effective, fda consumer, july-aug. 2003, available at http://www.fda.gov/fdac/features/2002/402_drug.html. 48. improving pubuc health, supra now 47. 49: creech, supra note 2, at 607. 50. tamar v. terizian, notes and comments. direct-to-consumer prescription drug advertising, 25 am. j. l. & med. 149, 157 (1999). 2005] the disparity 1n av ailabjlity of prescrjption drugs 275 person's ability to function. 51 often very few realistic drug substitutes exist and in certain cases, once prescription drug use has begun, it must be con­ tinued for a continuous period of time (e.g., anti-depressants). moreover, numerous prescription drugs can be highly addictive, which can affect such a drug's demand as well. where consumer demand is inelastic to price, phanna­ ceutical companies can charge more for a product than they could in a· market where consumer demand fluctuates in response to drug price. 52 with such a strong and stable consumer demand in addition to the limited governmental regulation in this area, pharmaceutical companies ultimately set the price of prescription drugs in the united states. 53 a. general pricing structure of pharmaceutical drugs in the united states as mentioned above, pharmaceutical manufacturers operate in a free market system and are able to price products in the united states at whatever level they wish, subject to minimal structural restrictions. 54 most of these firms are engaged in all phases necessary to bring a prescription drug to market, including the "[r&d] of different compounds, pushing new medicines through clinical trials, obtaining fda approval, and the advertising and mar­ keting of new drugs. "55 because these pharmaceutical manufacturers are involved in every aspect of bringing a drug to market, they have broad dis­ cretion in setting prices. 56 r&d expenses are the chief component behind the high costs of phar­ maceutical drugs. to bring a new drug to market requires a substantial invest­ ment of time and resources. in addition, many of the costs associated with this process are sunk costs and therefore, largely unrecoverable once spent. 57 studies indicate that the average new drug costs $800 million to develop and bring to market, 58 a process which takes an average of fourteen years. 59 while this high cost seems unreasonable at first glance, it is necessary to consider that "of every 5000 potential new drugs tested in animals, only five are 51. patriciam. danzon, piiarma.ceuticalprice.reoul.ation: nationalpoucies versus global interests 11 (1997). 52./d. 53. trudy lieberman. health matters: why health costs sting again, l.a. times, jan. 21,2002, at sl. 54./d. 55. creech, supra note 2, at 598; stanton, supra note 41, at 153. 56. stanton, supra note 41, at 155. 57. /d. ("sunk costs are those incurred in preparing to bring a product to market .... "). 58. the ballooning price tag, tuffs e-news, dec. 4, 2001, at http://www.tufts.edulcommunications/stories/120401ballooningcosts.htm(lastvisitedapr.17, 2005) (on file with the indiana health law review). · 59. whliam c. steere, jr., 'dioughi's toward a medicare drug plan (center for the study of am. bus., ceo series issue no. 35, sept. 1999), available at http ://we. wustl. edu/ csab/csab %2 opubs-pdf01o20 fi les/ce0%2 0 series/ceo 35%20medicare%20drugs.pdf. 276 indiana health law review [vol. 2:267 promising enough to be tested in humans. only one of those five is eventually approved for marketing.'>60 logically, the revenues derived from successful medicines must not only cover the r&d expenses involved in their own development; but also the r&d costs of the unsuccessful medicines as well.61 moreover, a pharmaceutical company must have the financial resources in place to develop and test thousands of compounds, knowing that very few of them will ever reach consumers and thereby potentially reap a profit 62 thus, the profits from the successful drugs must be high enough to cover the r&d expenses of the drugs that never reach the market.63 if drug manufac­ turers charged only the marginal cost of drug production-the cost of making each new pill-they would never recover their research costs, and the drug business would not be profitable. 64 while critics concede developing and introducing a new drug into the market is an unquestionably expensive process, they have pointed out''that the billions of dollars spent on r&d do not come out of the drug companies' pockets alone.'>6s in 1994, the united states federal government contributed fifty-five percent ofthe total amount spent on pharmaceutical drug r&d.66 the national institutes ofhealth (nih) is the main source of most federally provided health care r&d funds. 67 nih funds have been used to develop one third of the most important drugs developed between 1965 and 1992.68 while federal funding does exist, pharmaceutical companies invest tremendous amounts of their own money on r&d as well. it is not uncommon for large pharmaceutical companies to invest several billion dollars annually in r&d, over and above any federal aid they may receive.~ if pharmaceutical 60. the ballooning price tag, supra note 58; see also questions about medicines, supra note 2, at 2 (providing graphical depictions of the r&d costs and stating, "[t]he average cost ofbringing one new medicine into the market is $500 million ... [and] takes an average of twelve to fifteen years to discover and develop.;. note the $500 million cost to bring to market was the statistic as of june of2000, which subsequently increased to $800 million by december of2001. abbot laboratories estimates it costs $900 million to carry one drug all of the way through to market. john leonard, abbotr laboratories. new developments in medicine in the 21st century (oct. 2, 2003), available at http://abbott.com/citizenship/pdf/gpai.pdf(on file with the indiana health law review). 61. questions about medicines, supra note 2. 62. sarah e. burek. hatch-waxman reform and accelerated market entry of generic drugs: is foster necessarily better?, 2003 duke l. & tech. rev. 18 (2003). 63. /d. 64. latham. supra note 17, at 147. 65. creech, supra note 2, at 601; michael b. moore, "open w'uie" (your pocketbook that is!)call for the &tablishment in the united states of a prescription drug price regulatory agency, 1 sw.j.l.&tradeam.149, 156(1994). 66. creech, supra note 2, at 601. 67. moore, supra note 65, at 157. 68. id. at 156. 69. on the high end, pfizer, inc. budgeted $7.1 billion for r&d in 2003. pfizer inc., how we help: research and development, at http://www.pfizer.com/help/index.html (last visited apr. 17, 2005) (on file with the indiana health law review). additionally, eli lily spent $2.15 billion on r&d expenditures in 2002. ell lnly & company, annual report 2002 (2003), 2005] the disparity in av all..ability of prescription drugs 277 r&d relied solely on subsidies from the federal government, the level of innovation currently seen in the united states pharmaceutical industry would be reduced, simply because the government could not afford to fund the current level ofr&d expenses. however, as long as individual companies are spending their own money on r&d, they will be at liberty to set their prices (absent government price caps or other limitations). b. effects of increased pharmaceutical prices in the united states two main effects have resulted from the increased costs of united states phannaceuticals. the high profits in the american drug industry create strong incentives for united states pharmaceutical companies to promote research of new drugs. thus, high prices ensure that americans will continue to promote the development of, and have access to, the most innovative drugs in the world.70 increased united states innovation is made apparent by the sub­ stantially longer wait international consumers must endure for access to new medicines as compared to american consumers. 71 on the other hand, cutting edge medicines are of no use to consumers who cannot afford to purchase them. 72 an increasing number of people in today's society are finding themselves unable to afford their prescriptions and are consequently being forced to seek similar pharmaceuticals from more affordable sources outside of the united states.73 while this problem is not limited to the elderly, the increase in the number of elderly people in the united states has added to the gravity of this problem. "everyday millions of americans ... must choose between buying food or medication or between [sic] taking the fully prescribed dosage of medicine[,] or cutting their pills in half because a refill is too expensive."74 it is for this reason that american consumers are turning to the less regulated, cheaper foreign markets. when http:/llilly.com/investor/annual_reportllillyar2002financial.pdf(lastvisitedapr. 17, 2005) (on file with the indiana health law review). abbott laboratories reports it spends more than $1 billion annually on r&d. abbott laboratories, corporate overview, at http://abbott.com/ corporate/corporate_ overview.html (last visited apr. 17, 2005) (on file with the indiana health law review). merck & co. reported spending just under $3.2 billion in 2003 on r&d which was a nineteen percent increase from their 2002 r&d expenses. merck & co. inc., annual report 2003 (2004), http:/lwww.merck.com/financelannualreport/ar2003/fmancial _sectionlmerck2003_ar_financials.pdf(last visited apr. 17, 2005) (on file with the indiana health law review). 70. creech, supra note 2, at 603. 71. npr broadcast, supra note 40. 72. jd. according to rep. sanders ofvermont, foreign countries value innovative drugs as well. but they also realize innovative drugs are only useful if their citizens are able to afford them. id 73. mcclellan fda speech, supra note 1. 74. creech,supranote2, at 593 (citing 146cono.r.ec. 87193, (dailyed. july 19, 2000) (statement of sen. jeffords)). "in a study by the aarp, it was revealed that seven out of ten elderly americans surveyed did not take the medicines prescribed to them because of the high costs." ld (citing moore, supra note 65, at 152 n.20). 278 indiana health law review [vol. 2:267 forced to choose between poor quality of life and the risk of possibly using counterfeit, contaminated, or ineffective foreign pharmaceuticals, these con­ sumers are deciding to take their chances. a balance must be struck between the consequences of increased prices of united states pharmaceuticals and the promotion of prescription drug inno­ vation. while the united states asserts that it produces the world's leading drugs, there is no assurance that the people who need these drugs will be able to afford them. 75 advocates of the current pharmaceutical system could argue that the supreme court has held there is no constitutional right to health care,76 and therefore, there is no legal basis for prescription drug policy reform. on the other hand, it could be contended that a moral obligation exists to assist the disadvantaged. 77 if viewed from a purely business perspective, united states phar­ maceutical companies are merely creating a product and selling that product for a profit. such companies are provided protection for their patent rights under the united states constitution.78 while some believe companies have a moral obligation to make their drugs affordable, patent protection makes no distinction between products functioning as necessities versus luxuries. 79 75. creech, supra note 2, at 594. 76. deshaneyv. wmnebagocountydep'tofsoc.serv.,489u.s.189, 198-204(1989) (holding the united states government is not obligated or liable to providing any affirmative social guarantees); youngberg v. romeo, 457 u.s. 307, 317 (1982); cont'l paper bag co. v. e. paper bag co., 210 u.s. 405, 423 (t 908) (holding the united states constitution evinces no public policy that states a patent holder has to cede the use or benefit of his invention to the united states); wideman v. shallowford cmty. hosp., 826 f.2d 1030,1031 (llth.cir. 1987). 77. while one could not be punished in the united states for a moral violation absent statutory codification of the specific offense, the majority ofunited states law and policy is grounded upon moral prlriciples. health care is an area where mqral principles are weighing more and more heavily into policy decisions. the establishment of medicare and medicaid constitutes a clear expression of the american public's willingness to assist the disadvantaged, even at significant taxpayer expense. normandaniei3bt al., benchmarks off airnessfor health care reform 17 (1996); thomas h. murray, genetics and the moral mission of health insurance, hastings ctr. rep., nov.-dec. 1992, at 12, 16-17. likewise. the emergency medical treatment and active labor act (emtala), 42 u.s.c. § 1395dd (2004), is another example of american society's growing concern about moral fairness in the health care arena. sharona hoffman. unmanaged care: towards moral fairness in health care coverage, 781nd. l. j. 659, 672-73 (2003). emtalarequires hospitals to screen all patients who arrive in their emergency departments and stabilize their conditions regardless of the patient's ability to pay for those services. 42 u.s.c. § 1395dd(a)-(b) (2004). 78. u.s. const. art. i, § 8, cl. 8. (''the congress shall have power ... to promote the progress ofscience and useful arts, by seeming for limited times to authors and inventors the exclusive right to their respective writings and discoveries .... "). it should be noted that the constitution only provides for a monopoly over the patented product, it does not guarantee a profit from those patent rights. 79. 35 u.s.c. § i 0 l (2004)("whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title."); see also u.s. const. art. i, § 8, cl. 8. 2005] the disparity jn availability of prescription drugs 279 ill. foreign pharmaceuticals and quality issues because of the pricing discrepancy between united states and foreign pharmaceuticals, many americans have turned to importing foreign manu­ factured drugs.on their own.80 the potential savings are hardly trivial, given that an estimated "$90.7 million a year could be saved if drugs for state employees and retired employees were bought across the border in canada. •.st while american consumers claim this is the only way they can obtain the medicines they need, the safety of such a practice is questionable. above au, foreign pharmaceuticals are not subject to regulation by the fda, leaving much to chance in terms of the drugs' safety.82 one example of the risks posed by consumer importation of foreign drugs is provided by a 2001 congressional study. the report found that the large amounts of drugs that had been re-imported into the united states have created health and safety risks to american consumers. 83 the analysis focused primarily on american drugs that have been re-imported into the united states as american goods returned (agrs). a major problem presented by re­ imported drugs lies with the improper handling and shipping by foreign countries, which introduces the possibility that the drugs may have become subpotent or adulterated. 84 the congressional report also revealed that re­ importation of american drugs acted as a catalyst and cover for the foreign counterfeit drug market 85 when a pharmaceutical manufacturer is granted a patent for its new drug, the chemical structure of that patented drug, and frequently its chemical synthesis, can be found in either the patent application or in subsequent phar­ maceutical literature. 86 "pharmaceutical peddlers are taking advantage of regulatory gaps to move millions of prescription drugs, including controlled 80. jennifer rak, note, an rxfor reform: a medicare prescription drug benefit, 12 heal1hmatrjx 449, 449 (2002). 81. monica davey, illinois seeks permission to buy drugs, n.y. times, oct. 27, 2003, ata12. 82. michelle meadows, imported drugs raise safoty concerns, fda consumer, sept­ oct. 2002, available at http://www.fda.gov/fdac/features/2002/502 _ import.html. 83. u.s. food & drug admin., dep't heal1h & human servs., the prescription drug marketing act report to congress 2 (jwle 2001) [hereinafter fda prescription drug marketing act report], available at http://www.fda.gov/oc/pdma/report20011 4228tpt.pd£ 84. id. "adulterated" is defined as a foodstuff containing "any poisonous or deleterious substance which may render it injurious to health •.. [or] if it bears or contains any added poisonous or added deleterious substance •.• that is unsafe within the meaning of section 346 of this title." 21 u.s.c.a. § 342(a)(l )-(2) (2004). a foodstuff is also termed adulterated "if it has been prepared, packed, or held wlder unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to nealth." id. 85. fda prescription drug marketing acr report, supra note 83. 86. glenn law, note, liability under the process patent amendments act of 1988 for the use of a patented process outside the united states, 60 geo. wash. l. rev. 245, 247 (1991). 280 indiana health law review [vol. 2:267 substances, into the united states from mexico, canada, and elsewhere."87 with advancing technologies, the internet providing easy access to informa­ tion, and the ability to set up web ventures, counterfeiting pharmaceuticals has become an increasingly more prevalent and serious problem. 88 frequently, such counterfeiters do not even need access to the drug's chemical structure.89 canadian drugs are not fda regulated, providing no guarantee for their safety or efficacy. 90 therefore, when americans travel to canada to purchase cheaper pharmaceutical drugs they cannot be sure what they are buying. in addition, it is possible that· such consumers could be unknowingly buying counterfeit medicines which could cause substantial hann to their health and livelihood. thus, it is necessary for the united states to adopt a solution which caters to keeping drugs both affordable and safe. iv. canadian. patent law only forty years ago, the high costs of pharmaceutical drugs were causing problems in canada similar to the dilemma facing the united states today.91 canada was unable to promote the public welfare due to the extensive prices of pharmaceutical drugs. at that time, the prices of canadian pharma­ ceutical drugs ranked among the highest in the world. 92 in 1968, the canadian government responded by enacting legislation that mandated the licensing of the patented drugs to generic manufacturers in order to have the effect of price control.93 nevertheless, twenty years following the 1968licensingmandate, parlia­ ment decided an unreserved compulsory system excessively encroached upon patent holders' rights, effectively diminishing incentive for innovation among researchers.94 while the compulsory licensing system was effective in decreasing the costs of phannaceutical drugs to the public, it also decreased the monetary incentive for canadian pharmaceutical manufacturers to invest in ongoing research in pursuit of novel drugs and, therefore, new patents. moreover, the united states was exerting pressure on canada to reject the compulsory licensing system because it enabled individuals or corporations 87. mcclellan fda speech, supra note 1. 88./d 89. harrison, supra note 3, at 494. 90. meadows, supra note 82. 91. stanton, supra note 41, at 160. 92. id. 93. id such mandatory licensing of patented dmgs to generic manufacturers is also referred to as compulsory licensing. compulsory licensing was not a new concept in canada, as their use of compulsory licensing can be seen as far back as the 1923 amendments to the patent act. joel lexchin, pharmaceuticals, patents, and politics: canada and bill c-22, 23 int'lj.iiealth servs. 147, 148 {1993). 94. patricia i. carter, federal regulation of pharmaceuticals in the united states and canada, 21 loy. l.a int'l& comp. l. j. 215, 242 (1999). 2005] the disparity in availability of prescription drugs 281 to obtain a compulsory license from the canadian commissioner of patents and use a united states patented process to manufacture a drug in canada.95 in effect, the compulsory licensing system was facilitating the misappropria­ tion of united states patents. the united states opposition to the canadian licensing policy was so powerful and widespread that by october of 1985, the united states trade representative complained in his annual report ''that canada's compulsory licensing policy was costing u.s. companies 'hundreds of millions of dollars .... 96 pharmaceutical companies in the united states were among the loudest voices heard in favor of using the united states' political force to encourage canada to abandon its compulsory licensing system. influenced by interior concerns as well as political pressure from the united states, the canadian parliament implemented a compromise by granting the patent holder an exclusive term for at least seven years, after which mandatory licensing could be imposed. <n however, such a compromise was not sufficient to satisfy the united states, and after extensive negotiation, the north american free trade agreement (nafta) eliminated compulsory licensing altogether.98 in 1993, canada implemented bill c-91 and brought canada into compliance with nafta's terms.99 seven years prior to bill c-91, the canadian parliament had established the patented medicine prices review board (pmprb) in anticipation of nafta's adoption.100 the pmprb remains in effect today and serves as a review board possessing the power to compel disclosure of canadian phar­ maceutical manufacturers' confidential information concerning their drug pricing.101 after the pmprb reviews the pricing information, it sets a whole­ sale price for the drug, which incorporates and accounts for a reasonable return on the patent holder's investment.102 this price serves as a cap which the pharmaceutical manufacturer cannot exceed.103 95. harrison, supra note 3, at 505-24. 96. id. at 512 (quoting david crane, drug bill concessions seem tied to trade talks, torontostar,dec. 7, 1986,atb1). 97. carter, supra note 94, at 242. 98. harrison, supra note 3, at 511-24; stanton, supra note 41, at 160 ... among other provisions, nafta mandates twenty year patent terms from the date of filing ... and the elimination of compulsory licensing in all but a few limited circumstances, inapplicable here." i d. 99. carter, supra note 94, at 243. 100. id. at 245. in 1987, bill c-22 created the pmprb with the aspiration that the board could prevent drug manufacturers from taking advantage of their increased patent protection under nafta by charging higher prices. patented medicine prices review board, drug patents and drug prices: the role of the pmprb, at http://www.pmprb­ cepmb.gc.calenglishlview.asp?x=l34&mid=66 (last visited apr. 17, 2005) (on file with the indiana health law review). 101. moore, supra note 65, at 156-66; see also creech. supra note 2, at 615. 102. moore,supranote65, at 164; stanton,supranote41, atn.ioo. "thepmprbhasno jurisdiction over retail prices." id. 103. creech, supra note 2, at 615. 282 indiana health law review [vol. 2:267 initially the pmprb was authorized to invalidate the drug's patent in canada if the manufacturer failed to comply with the mandated information requests or pricing.104 however, in 1993, that invalidation power was stripped from the board and replaced by the power to merely impose financial penal­ ties.105· canada continues to use the pmprb as the price control authority over pharmilceutical drugs, and it has been successful in keeping drug prices low.106 the evolution of canadian patent law offers a valuable tool to the united states.· in drafting prescription drug reform. history illustrates the direct correlation between strong patent rights and increased innovation and vice versa. likewise, the creation and success of the pmprb shows that a review board can exist and determine reasonable market prices for pharmaceutical drugs.· while following canada's lead entirely may not be the most effective approach,107 it would be wise to consider canada's experience·in reshaping united states policy. ' v. unitedstatespatentlaws a. constitutional grant of power the power to patent an invention originates directly from the united states constitution: "the congress shall have power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries •••• " 108 this reference to patent protection in the founding document of the united states evidences the long term commitment and historical importance attributed to patent rights. the main pwpose of the patent system in the united states is exactly as the patent clause reads, to promote the progress and science of the useful arts. while inventors are rewarded via the monopoly bestowed upon them when they are granted a patent, the monopoly is merely a means to that end.109 the patent clause grants all governing authority to congress, a textual reading of this clause suggests congress has a type of all or nothing ability to grant patent rights: "congress may either grant exclusive rights in the patented article, or grant no rights at all."ho 104. moore, supra note 65, at 163. 105. ld. at 164; patented meds prices review bd., fifi'h annual report for the yearendbddec. 31,1992, at 3 (1993). i 06. moore, supra note 65, at 164. 107. stanton, supra note 41, at 161-62 (noting that canada is now a very small contributor to the ''world's pharmaceutical pipeline. j. ld. at 162. the significant differences between the two nations must be taken into account as well, including canada's population is considerably smaller than that of the united states and is under a nationalized health care system. 108. u.s. const. art. i,§ 8, cl. 8. 109. see u.s. v.mansonitecorp., 316u.s. 265 (1942);seealsosinclair& carroll co. v. interchemical corp., 325 u.s. 327 (1945). 110. stanton,supranote41, at 150. 2005] the disparity ln av all..ability of prescription drugs 283 patent laws allow the patent holder to. exclude people from using, providing or selling the invention throughout the united states in the absence of a license granted by the patent holder. 111 in fact, the united states supreme court has construed the patent clause narrowly, indicating that ''the language of complete monopoly has been employed."112 in the case ofpha.rmaceutical drugs, patent rights bar competition from generic competitors for a period of twenty years from the filing of ~e patent.113 pharmaceutical companies consider this term vital to their survival and to the continuous production of innovative drugs in order to combat the "free rider problem."114 moreover, because only one out of every ten drugs produced by pharmaceutical com­ panies actually makes it to the market, the monopoly granted through their patent rights affords them the funds necessary to recoup their r&d expenses of not only the drug that is being sold, but the other nine drugs which did not advance into the marketplace.115 b. international influence on united states patent law 1. extraterritorial effects ofunited states patents while the constitution and subsequent legislation confer the benefits of a monopoly upon the patent holder, these rights generally only have effect within the borders of the united states. courts and analysts have often stated that patent rights do not have any effect abroad, absent some form of infringement within the united states.116 the supreme court has taken the position that, "(t]o the degree that the inventor needs prote9tion in [foreign] markets ... the wording of [the statute] ... reveals a congressional intent to ill. deepsouthpacldngco.,lnc. v.laitramcorp.,406u.s.518(1972)(interpretingwhat is now codified as 35 u.s.c. § 271 (a}{ c), (e)(l), (f) (2004)). 112. cont'l paper bag co. v. e. paper bag co., 210 u.s. 405, 423 (1908). 113. 35 u.s.c. §l54(a)(2)(2005). ltshouldbenoted,how'ever, thatthistwentyyearterm granted to the patent holder, on average, is reduced to a term of only ten to twelve years on the market free of generic competition due to the time it takes to put the drugs through clinical trials and to gain fda approval. patricia m. danzon & li-wei chao, does regulation drive out competition in pharmaceutical markets?, 43 j. l. & econ. 311, 312 (2000). 114. see harrison, supra note 3, at 461-62. pharmaceutical drugs are especially susceptible to this "free riderproblem"becauseofthe enormous discrepancy that exists between the r&d costs of drug development and the manufacturing costs once the correct compound has been determined. id once a foreign pharmaceutical company has obtained the drug's chemical structure (either through reverse engineering or similar method), it can then sell the drugs at a lower price than the united states' pharmaceutical companies because there is no r&d overhead to recoup. lehman, supra n~ 10, at 395. this situation has been termed the ''free rider problem," and if allowed to continue unchecked, eventually these public goods will be underproduced. janice m. muei..ler, an introduction to patent law 7 (2003). 115. questions about medicines, supra note 2. 116. curtis a. bradley, territorial intellectual property rights in an age of globalism, 37 va. j.int'l l. 505, 507-08 & n.8 (1997) (demarcating the original scope of the direct infringement statute). 284 indiana heal til law review [vol. 2:267 have him seek it abroad through patents secured in countries where his goods are being used. "117 _ for this reason, american phamiaceutical companies cannot exert legal pressure upon canadian drug manufacturers who duplicate their patented medicine (assuming the united states pharmaceutical companies have not obtained a canadian patent). this is true as long as such drugs are not used, produced or sold in the united states. 118 however, it is clearly a violation of patent rights when american citizens obtain such "generic" medicine from canada and transport these drugs into the united states for their use.119 2. the doctrine of exhaustion · · nevertheless, a fundamental limitation on patent rights is the doctrine of exhaustion upon first sale.120 the doctrine of exhaustion has not been codified by the united states' patent act, however, it has been clearly established in common law .121 the courts have justified this doctrine by stressing that the patent purpose122 is accomplished once the patent holder has received the benefit of the initial sale of the patented article. 123 while canadian drug manufacturers are selling generic versions of the united states patented drugs for discounted prices, american-made drugs are also available in canada. currently, it is not uncommon for individuals or companies to purchase american-made pharmaceuticals in canada, where the drugs are cheaper, and subsequently re-import those drugs to be resold in the united states.124 these "re-imported" drugs are classified as parallel imports, which are goods sold or authorized for sale abroad by the united states patent holder, then subsequently re-imported and sold in the united states without 117. deepsouth packing co., inc. v. laitram corp., 406 u.s. 518, 531 (1972); see also henry g. grabowski, healtii reform and pharmaceutical innovation 19, 14-15 (1994). 118. deepsouth packing co., 406 u.s. at 526-27 (interpreting what is now codified as 35 u.s.c. § 271 (a)-( c), (ex1), (f) (2004)). 119. 35 u.s.c. § 271 (2004). 120. darren e. donnelly, comment, parallel trade and international harmonization of the exhaustion of rights doctrine, 13 santa clara computer & high tech. l.j. 445, 447 (1997). the doctrine of exhaustion or first sale provides that "once the patentee releases a patented product into the stream of commerce by selling or authorizing it to be sold to another, he exhausts his legal right to control that product." margretii barrett, intellectual property: cases and materials 268-69 (2d ed. 2001 ). therefore, the first purchaser, and those deriving title from him, may use and resell the product at will; see, e.g., aro mfg. co. v. convertible top replacement co., 377 u.s. 476 (1964). 121. barrett, supra note 120, at 269. . 122. the purpose for the patent act is to benefit inventors in order to create incentive to stimulate greater creative endeavors. see u.s. const. art. i, § 8, cl. 8. 123. barrett, supra note 120, at 274. 124. a. bryan baer, note, price controls through the back door: the parallel importation of pharmaceuticals, 9 j. intell. prop. l. 109, 109-10 (2001). 2005] the disparit'y ln av ailabillty of prescription drugs 285 the original patent holder's authorization.125 once re-imported into the united states, the goods are in direct competition with the patent holder's goods. for that reason, international application of the doctrine of exhaustion is inherently capable of frustrating patent holders' attempts to maximize the value of their property rights. 126 two competing theories have emerged regarding the doctrine of exhaus­ tion: the "international exhaustion" theory, providing the doctrine of exhaus­ tion should apply regardless of the location where the goods are sold, and the "domestic exhaustion theory," providing the doctrine of exhaustion should be limited to patented articles manufactured and initially sold within the territory of the united states.127 international exhaustion is a controversial theory because it is contrary to the traditional notion that patent rights do not extend extraterritorially.128 patent owners, especially in the pharmaceutical industry, argue that because patent rights are created by "domestic statutes of restricted territorial scope," the discounted sales of their patented products in a foreign market cannot exhaust their domestic patent rights.129 moreover, the united states patent holders assert that because they are selling their drugs at a dis­ count to foreign consumers, they have not received full value of their patented product. 13o the united states has not yet recognized the notion of international exhaustion with respect to patented items, although it has tolerated the theory in certain categories of copyrighted and trademarked goods. 131 moreover, the united states patent act expressly provides that the unauthorized importation of a patented invention is an actionable infringement.132 finally, the united states supreme court enjoined the importation of a product covered by a united states patent but acquired abroad from an authorized source in its only decision regarding parallel imports of patented goods.133 because the doctrine of exhaustion has been limited to domestic application, a state or the federal 125. hillary a. kremen, note, caveat venditor: international application of the first sale doctrine, 23 syracuse j. int'l l. & com. 161, 161·62 (1997). 126. david perkins et al., exhaustion of intellectual property rights, in 2 pli's fifi'h annual institute for intellectual property law, at 41, 43, 4546, 57 (pli patents, copyrights, trademarks and literary property handbook series no. 574, 1999). 127. barrett, supra note 120, at 274. 128. mueller, supra note 114, at 364. 129. /d. at 365. 130./d. 131. jd.; see quality king dist., inc. v. l'anza res. int'l, inc., 523 u.s. 135 (1998) (copyrighted goods); k mart corp. v. cartier, inc., 486 u.s. 281 (1988) (trademarked goods). 132. see 35 u.s.c. § 27l(a)(2004)(including in the definition of patent infringement the "import{ation] into the united states" of any patented invention ''without authority."). 133. boesch v. graff. 133 u.s. 697 (1890). boesch's rejection of the international exhaustion doctrine was relied upon over one hundred years later in jazz photo corp. v. int 'i trade comm'n, 264 f.3d 1094 (fed. cit. 2001), holding that for an accused infringer "{t]o invoke the protection of the first sale doctrine, the authorized first sale must have occulted under the united sta~ patent." ld. at 1105. 286 indiana health law review [vol. 2:267 government would be liable for infringement if they attempted to subsidize the re-importation of united states pharmaceuticals bought in canada. c. the fifth amendment and just compensation a patent is a property right conveyed upon the patent holder as a reward for their innovation.134 thus, its use is subject to all protections and limits afforded by the fifth amendment to the united states constitution. the fifth amendment imparts, "[n]o per8on shall ... be deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation. "135 in the proverbial bundle of rights which symbolize the rights charac­ teristic of property, perhaps the most important stick is the power to exclude others. 136 from a patent perspective, this is an essential right, as the substantial value of a patent is derived from the patent holder's ability to exclude potential competitors from manufacturing the patented product, resulting in. the patent holder's domination of a niche in the industry. a patent holder can bring an action directly against the alleged infringer if that infringer is a member of the private sector, however, when the infringement is one of government action, the law is more complicated. federal law waives the united states govemritent's immunity from private suit, while concurrently allowing the federal government or its contrac­ tors to legally infringe upon a valid patent for the government's use.137 where the government infringes upon a patent on section 1498 grounds, this is a taking under eminent domain,138 which entitles such a patent holder to "reasonable and entire compensation for such use and manufacture!'139 a 134. see markman v. westview instruments, inc., 52 f.3d 967, 985 (fed. cir. 1995). 135. u.s. const. amend. v. 136. stanton, supranote41, at 151; seeln re etter, 756 f.2d 852,859 (fed. cir. 1985). 137. 28 u.s.c. § 1498(2004);danielrcahoy, treatingthelegalsideeffectsofcipro: a reevaluation of compensation rules for government takings of patent rights, 40 am. bus. l. j. 125, 139-40 (2002). in 1910 a house of representatives report accompanied the bill wbichbecamethepredecessorstatutetosection 1498. id at 140n.61. the report stated, "[o}ur only purpose is ... to give the court in patent cases, in addition to the jurisdiction it now has in matters of contract, jurisdiction in cases of tort." id 138. see leesona corp. v. united states, 599 f.2d 958 (ct. cl. 1979}; cahoy, supra note 137, at 142. the founding fathers, concerned with the possibility of government tyranny, placed an important limitation upon the government's power of eminent domain: "a requirement that fair compensation be given by the government for any taking of property." id id 139. 28 u.s.c. § 1498(a) (2004). whenever an invention described in and covered by a patent of the united states is used or mailufilctured by or for the united states without license of the owner thereof or lawful right to use or manufacture the same, the owner's remedy shall be by action against the united states in the united states court of federal claims for the recovery ofbis reasonable and entire compensation for such use and manufacture .... 2005] the disparity in availability of prescription drugs 287 patent taking under eminent domain can be likened to the government offering fair market value for a residence in the projected path of a new highway system. while the government is authorized to take the house, compensation must be made to the owners at a fair and just price. likewise, jllst ·as a homeowner is prohibited from refusing to sell their residence, section 1498 preeludes a patent holder from asserting an injunction against the united states to prohibit use of his patent. 140 however, this statute does not eliminate the patent holder's fifth amendment right to just and reasonable compensation. "[l]f taking the property is truly important for the good of the state, the state (and the taxpayers who support it) should be willing to pay a fair and just price for it. "141 determining that fair and just price introduces another complication into the fifth amendment scheme. when pharmaceutical companies price their ckugs they take into account that the profits from the successful drug must ()()v.er the r&d costs of the other drugs that did not reach the market.142 the exact r&d costs of the unsuccessful drugs could also be a question of accounting and the length of time that the pharmaceutical companies choose to sprea9 their loss. future profits and loss spreading make it difficult to deter­ mine exactly what fair and just compensation would be in any given situation. d. compulsory licensing as a taking jn the patent context, a taking by the united states government has tradi­ tionally been in the form of a "compulsory compensable license in the patent."143 just compensation has usually been calculated as "reasonable royalty" for the use of that license, or when that cannot be established-as often is the case-another method of calculating the value of the appropriated patent will be employed. 144 such government appropriations of patents have been relatively rare in the past, but with the evolving worldwide epidemics­ hiv/aids, trachoma, avian influenza, etc.-and the increasing threat ofbio­ terrorism in the united states, as evidenced by the october 2001 anthrax scare, actions under section 1498 have become increasingly ominous.145 further, if 140. caboy, supra note 137, at 152; see. e.g., motorola, inc. v. united states, 729 f.2d 165, 768 n.3 (fed. cir. 1984) (stating "injunctive relief under 35 u.s.c. § 283 is not available to a patent owner in a § 1498 action."); see also leesona corp., 599 f.2d at 968 ,"the injunctive relief of35 u.s.c. § 283 could not be awarded, of course, since this court lacks the power to grant such relie£" id. 141. caboy, supra note 137, at 142. 142. burek, supra note 62, at 18. 143. leesona corp., 599 f.2d at 968. 144. id. 145. john a. harrelson, note. trips, pharmaceutical patents, andthehiviaidscrisis: finding the proper balancebetweenlntellectualproperty rights and compassion, 7 widener l.symp.j. 175, 175(2001); caboy,supranote 137,at 125~26. in0c:toberof2001,theunited states experienced a major threat to its national security as a result of bioterrorism. the designed release and distribution of bacillus anthracis ("anthrax'') throughout the country created a widespread panic among the american public. government discussion quickly moved 288 indiana health law review [vol. 2:267 section 1498 actions are employed by the government and a compulsory license is issued, the entire process could cost the government more, as the patent holding company must be compensated, and payment would be rendered to the generic pharmaceutical manufacturer that actually made the drug.l46 pharmaceutical companies often strongly protest compulsory licensing, even when they are awarded what the courts determine to be reasonable and full compensation. one reason for this is that "reasonable compensation" is largely ambiguous on its face and the reasonableness of a damage award is likely to depend on whether the pharmaceutical companies or the courts are making the judgment. 147 additionally, "a rule creating a disadvantaged com­ pensation scheme for government appropriated patents would be perceived as weakening the intellectual property right for affected arts."148 it would be reasonable to expect to see a reduction in investment in research areas more apt to be subject to governmental takings if such a government action became exceedingly widespread.149 companies would simply not be willing to invest the necessary capital on innovative research if the capability to make future profits was likely to be stripped, only to be replaced by ''reasonable compensa­ tion" to be decided by a court. while the reasons pharmaceutical companies may be opposed to com­ pulsory licensing are somewhat obvious, the united states government also has an interest in refraining from the appropriation of its patents. first, the united states has a strong interest in encouraging innovative research in the area of pharmaceutical drugs. it is perceivable that canada's model of price regulation through compulsory licensing does not provide the incentive necessary to maintain the level of pharmaceutical innovation currently seen in· the united states. 150 adequate incentives must be present in order for the united . states to remain among the countries with the highest levels of pharmaceutical innovation in the world. therefore, investment in research and development of new drugs is vital. a second incentive, and perhaps a less obvious one, is that the govern­ ment may be hesitant to employ compulsory licensing because of its possible effect on international relations. the united states does not want to underto the compulsory licensing of the patent rights to ciprofloxacin, the only antibiotic approved by the fda for treatment of inhalation anthrax, in order to decrease the cost of the drug by allowing a generic form to be produced by companies other than the original patent holder (the german pharmaceutical company, bayer, a.g.). /d. at 125-28. however, before the government "overrode" the ciprofloxacin patent. bayer promised to increase its production of the drug three-fold along with considerably reducing the price it charged the u.s. government. /d. at 127. 146. /d. at 171-72. 147. see, e.g., crozier v. fried. krupp aktiengesell-schaft, 224 u.s. 290, 307 (1912). 148. cahoy, supra note 137, at 170. 149. /d. iso. stanton, supra note 41, at 162, 167-68. 2005] the disparity in availability of prescription drugs 289 mine its negotiating position with developing countries over whether the agreement on trade-related aspects of intellectual property rights (the ''trips agreement'' or "trips") allows these countries to override .united states patents.151 developing countries have a strong interest in being.able to obtain the innovative drugs which combat diseases such as aids, but the majority of these drugs are manufactured by united states pharmaceutical companies. thus, overriding united states patents would successfullyenable them to.effectively address hiv/aids or similar pandemics.152 developed countries maintain that these drugs are only available because of the existence of a high level of patent protection, which allows pharmaceutical companies to be comfortable with investing the billions of dollars necessary for con­ tinuing r&d. 153 vi. potential solutions american consumers pay the highest prices in the world for pharma­ ceutical drugs. in exchange for this financial burden, americans enjoy increased access to the most innovative drugs, assuming their budgets allow. development of new and innovative drugs is dependent upon the strength of patent laws, or analogously, the promise of future profits. observing the evolution of the canadian patent system provides reinforcement for this theory .. after the canadian government weakened their patent laws-thereby depressing the possibility of profits for the drug companies--canadian phar­ maceutical innovation decreased. consumers may tend to under-value the possible benefits of a not-yet­ developed drug, since the unknown benefits would be pitted against the likelihood of high prices at the pharmacy. american consumers must decide if they are willing to sacrifice the potential for future developments of new life-saving drugs for smaller bills in the short-term. furthermore, if a high level of innovation is determined to be the ultimate goal, action should be taken by the federal government to create a solution for the class of individuals currently wiable to pay for prescription drugs. while permitting the importation of pharmaceutical drugs from canada may seem to be the straightforward and logical solution to the united states' increasing prescription drugs prices, in the long run it could have a severe and negative impact on american public health and the united states pharma­ ceutical industry. because such drugs are not fda regulated, the quality and effectiveness of foreign drugs cannot be guaranteed. moreover, allowing foreign pharmaceutical drugs into the united states market, especially through 151. james thuo gathii, the legal status of the doha declaration on trips and public health under the vienna convention on the law of treaties, 15 harv. j. l. & tech 291, 29495 (2002). 152.jd. 153. ld. at 294. 290 indiana health law review [vol. 2:267 internet purchasing schemes, amplifies the opportunity for counterfeit drugs to reach american consumers. although increasing fda funding may enable that agency to regulate foreign pharmaceutical imports, supplying fda officials with the financing required to detect and police these imports would likely compel either large tax increases or a significant increase in the united states deficit. for these reasons additional methods should be explored to increase the affordability of united states pharmaceuticals to the american public, and our borders should be closed to pharmaceutical drug imports. a. patent infringement as a matter of law, if a state or federal government were to import pharmaceutical drugs into the united states that were identical or substantially similar to those under a united states patent, the united states patent holder would have a valid claim of infringement and would entitle it to just and fair compensation. under the domestic exhaustion principle adopted by the supreme court, even american-made drugs sold abroad and subsequently resold in the united states without the original patent holder's authorization would be considered an infringement. in either of these cases, united states companies holding pharmaceutical patents could obtain an injunction against the infringer. section 1498 allows the federal government to prevent the patent holder from asserting an injunction against the united states. however, reasonable and entire compensation must be made for the use of the patent. the deter­ mination of what is reasonable and entire compensation for a pharmaceutical drug is a problematic and controversial process. if the government were to compulsory license a patented drug, determining its fair value would entail projecting the amount of future profits necessary to cover the r&d of not only the successful drug, but also the sunk costs of the unsuccessful drugs that never were approved for the market. if the united states government were to make a practice out of compulsory licensing, this would not only weaken united states pharmaceutical patents, but it would also undermine the united states' international stance that other countries must respect united states patents. either consequence would effectively decrease incentive for pharma­ ceutical companies to invest the sizeable amounts of money necessary for innovation. while non-fda regulated pharmaceuticals may not be the answer, a solution must be found, as the rising prices of pharmaceutical drugs in america is leaving significant amount of the population without access to pharmaceutical drugs. b. alternative solution: national prescription drug aid program the establishment of a centralized federal agency with limited and exclu­ sive regulatory power over prescription drug prices may be the answer. if this new federal program were employed, all prescription drug authority could be 2005] the dispartiy in availability of prescription drugs 291 removed from medicaid and medicare, eliminating any discrepancies between programs and providing equal protection for all who meet the eligibility requirements. the key to such a program would be achieving the most efficient need-based eligibility standard. such eligibility standards :should expand upon those currently utilized by the medicaid and medicare programs in order to encompass the largest percentage of the uninsured population. achieving this standard has the potential to save the government money in the long term, as providing preventative care through prescription drugs is often less expensive than providing emergency treatment.154 further research is needed to determine the income level at which an individual is likely to purchase pharmaceutical drugs, so as to achieve the appropriate eligibility standard. regardless of the solution adopted to combat the affordability problem of united states pharmaceuticals, it is highly likely additional funding will be necessary. if this prescription drug pricing agency were adopted, because of the program's federal nature, taxes could be spread throughout the entire united states population thereby reducing the impact on the individual. investing federal taxes into the proposed program would be considerably more efficient than funding the regulation of foreign phannaceutical imports which would create new problems and additional costs in long run. additionally, because the existing medicare and medicaid programs currently receive funding for their limited prescription drug benefit programs, a proportionate amount of those subsidies could be shifted to the new prescription drug agency. likewise, because the two existing programs' pharmaceutical drug benefits would effectively be excised and consolidated into one separate program, this would produce a more efficient system. theoretically, these factors could decrease the amount of additional taxation necessary to support the new agency. c. agency price determination the proposed federal program would operate in a similar fashion to the recent medicare prescription drug benefit act. the new agency would pur­ chase the drugs from united states phannaceutical companies at a discounted price. such price would be set by a review board similar to the pmprb utilized in canada. 154. janet o'kee:tfe, the right to health care and health care reform, in health care reform:ahumanrlghtsapproach35,40-41 (audreyr.chapman,ed., 1994). currently, the poor and uninsured must be admitted for expensive institutionalized care when their health has deteriorated enough that they require emergency treatment. id. . generally the costs associated with such emergency treatment greatly exceed the costs of the forgone preventative treatment. id. the discrepancy between these two costs is passed along to taxpayers by increased medical bills to all of society. id. 292 indiana heal til law review [vol. 2:267 this pricing board's authority would be limited to the federal program and would not extend to mandating price caps for the regular market. in contrast to the canadian pmprb, this pricing review board would not auto­ matically be authorized to compel disclosure of united states pharmaceutical manufacturers' confidential drug pricing information, given that it is unlikely united states pharmaceutical companies would cooperate with such a scheme. the review board's main function would be to assess the global market for the pricing of equivalent medicines and negotiate with the united states pharmaceutical companies to set a price falling somewhere in between the united states and global market prices. only in the event that a united states pharmaceutical company refuses to negotiate or agree upon a reasonable155 price may the review board be afforded the power to compel confidential pricing information from the uncooperative company. the agency price will then be set according to the review board's evaluation of the pricing information. all compelled pricing information should be kept strictly con­ fidential. the new agency would then purchase the pharmaceutical drugs directly from the manufacturers at the price agreed upon. eligible participants of the program could then purchase these drugs from the agency at the average global market price. for example, if the review board found the average global price of a certain prescription drug was $3.00 per pill and the price for the similar pill in the united states was $10.00, the review board and the united states patent holder would negotiate and set an agency price at $7.00 per pill. the agency would then purchase these pills from the pharmaceutical company at $7.00 per pill and subsequently make the drugs available to eligible individuals at $3.00 per pill. in this way, the agency would have to consume only a percentage of the pharmaceutical drug costs, thereby lessening the tax burden americans must bear. this program would provide a means for elderly and impoverished americans to have access to affordable and fda regulated pharmaceutical drugs. there is no reason this program should directly impact the market prices of united states pharmaceuticals. any drugs sold to the new agency would be above and beyond the companies' current sales, thereby extending the reach of pharmaceutical companies to a sector of the market previously unable to afford their product. due to the marginal costs associated with increased pill production, it seems the patent holders themselves can take advantage of the "free rider problem" while still increasing their profit margin since increasing production is not financially inhibitory. therefore, united states pharmaceutical companies could continue to cover their r&d costs and innovation would be spared. moreover, because the companies are being com155. the term ''reasonable" should be defined prior to the adoption of the agency. a suggestion for the reasonable standard would be to set the price as a set percentage above the global market price, however~ the precise definition can be negotiated for when the plan is enacted. 2005] the disparity in availability of prescription drugs 293 pensated for their products, this solution avoids any fifth amendment quandaries~ while the additional taxation necessary to fund the agency would indirectly increase the.burden of phannaceutical drug prices on more wealthy americans, this trend is not uncommon iri the united states. while critics may attack this program as throwing the weight of the problem onto the backs of the aflluent, this argument ignores the underlying predicament entirely. the problems associated with the current system of pharmaceutical drug pricing in the united states are not going to disappear without the implementation of a solution that impacts the public as a whole. the establishment of this new agency offers a solution that both meets the needs of americans who are pre­ sently unable to afford pharmaceutical drugs, and protects united states pharmaceutical innovation and the safety of the united states pharmaceutical drug supply. d. closing the borders merely establishing a centralized agency to help combat the affordability problem ofunited states pharmaceutical drugs will not resolve the issue alone. making american pharmaceuticals affordable for indigent individuals will be a significant step towards decreasing american consumer incentive to seek drugs outside of the united states. however, that incentive will remain for the people who do not qualify for aid. consumers cannot be relied upon to entirely discontinue. seeking out less expensive foreign drugs without the possibility of repercussions in place. the most efficient approach to securing the safety of the american drug supply. is to close the borders entirely to foreign drug imports. it would be unrealistic to expect an embargo on the importation of pharmaceuticals to prevent all foreign drugs :from entering the market. however, making the act of importation illegal may inadvertently increase the price of foreign pharmaceuticals, thereby lessening their appeal. additional funding will also be required to implement the stringent importation prohibition. however, it is not necessary that such funding be derived :from tax dollars.· the united states pharmaceutical companies have a substantial interest in closing the borders to foreign pharmaceuticals, as the competition weakens their market foothold. therefore, it would be in the united states pharmaceutical companies' best interest to fund the fda's implementation of a prescription drug import embargo. if adequate funding was not made available merely by placing the security control in the hands of these large companies, several avenues could be explored to increase their motivation. for example, united states pharma-. ceutical companies have large budgets reserved for dtc advertising. if such companies complained of the burden associated with their border respon­ sibilities, the federal government could simply prohibit dtc advertising for pharmaceutical drugs and those funds could then be devoted to securing the borders. securing the safety of the american pharmaceutical drug supply is 294 indiana health law review [vol. 2:267 more essential to promoting the public health than marketing prescription drugs to vulnerable consumers in search of the ''magic pill." vll. conclusion clearly. the pharmaceutical pricing situation cannot continue as it exists today. the importation of foreign pharmaceuticals violates federal law. infringes upon patent rights. weakens united states patent protection afforded by the constitution. and creates an imminent threat to the public health. because of the number of competing interests. the most effective solution is one of compromise. the creation of a central federal agency may not be the optimal. solution. however. it illustrates that an answer. can be found in a middle ground. the competing and intertwined interests complicate the over­ all issue. but also provide valuable bargaining power for compronme. if the optimal balance is struck. it will be possiple to make prescription drugs more affordable to the elderly and the uninsured while protecting drug innovation and quality. a proposal for comprehensive biobank research laws to promote transnational medicine in indiana jennifer girod* katherine drabiak** table of contents i. introduction ..................................................................................... 218 ii. the current regulatory and legal environment and lmplica tions for biobank research ....................................... 220 a. complex federal regulatory framework ................................. 220 b. public fears ofgenetic discrimination .................................... 223 c. ambiguity regarding tissue ownership ................................... 225 d. implications of the current regulations on biobank research ................................................................................... 229 e. ethical considerations .............................................................. 229 iii. state approaches to federal regulatory inconsistencies in genetic research ..................................... 231 a. state legislative responses: an overview of legal elements ................................................................................... 231 1. personal access to dna results ......................................... 232 2. informed consent and exemptions ..................................... 232 3. retention and destruction of dna samples and genetic information ........................................................................ 233 4. disclosure of results ........................................................... 234 5. property interests ................................................................ 235 6. civil and criminal liability ................................................ 236 b. state legislative strategies to protect donors or promote research efficiency .................................................................. 238 1. state laws that increase protections for tissue donors ..... 238 2. state laws that promote research efficiency ..................... 241 * j.d. 2007, indiana university school of law, indianapolis, indiana; b.a., 1990, m.a., 1992, a.s.n., 1996, ph.d., 1999, indiana university. the research for this article was supported by predictive health ethics research ("predicter"), a multidisciplinary research, policy and public education program of the indiana university center for bioethics funded by a grant from the richard m. fairbanks foundation, inc. indianapolis. thank you to all partici­ pants in pred icter weekly meetings, who offered comments and suggestions on earlier drafts of this paper. special thanks to eric m. meslin, ph.d., and jere o'dell, m.a., m.l.s., for their help. ** j.d. candidate, 2008, indiana university school oflaw, indianapolis, indiana; b.a., 2005, university of california, santa barbara. 218 indiana health law review [vol. 5:217 iv. indiana's legislative options .................................................•.... 242 a. existing indiana law related to genetic information .............. 243 i. repositories or genetic information databases ................. 243 2. indiana statutory definitions of genetic testing; insurance coverage ........................................................... 243 b. approaches to addressing indiana's lack of legislation ......... 244 i. status quo ........................................................................... 244 2. a comprehensive approach for indiana ............................. 245 a. tiered or blanket informed consent for all tissue use ... 245 b. disclosures andre-identification .................................. 247 c. liability ......................................................................... 247 d. implementation of legislative changes .......................... 247 (i) outreach and education ........................................ 248 (ii) integration of genomics into personal health care .............................................................. 248 (iii) evaluation and ongoing advisement ................... 249 v. conclusion ........................................................................................ 250 i. introduction "translational medicine" is a term that has come to signify the focused ef­ forts of bench scientists, drug developers, and clinical researchers to develop new medical products and improve health. 1 translational medicine is some­ times referred to as "molecular" or "personalized" medicine, and it generally involves the study of "disease and its pathology at the molecular level ... in­ cluding the levels of such molecules as dna, rna, proteins, and metabo­ lites."2 the hope is that this research will lead to personalized health care products, reductions of adverse drug reactions, better methods of identifying individuals at risk for disease, and improvements in preventive care.3 it may also eliminate waste in our health care system by decreasing the use of ineffec­ tive medications and drugs that cause adverse reactions.4 i. biobank central, what is translational medicine?, http://www.biobankcentral.org/ translational!whatis.php (last visited mar. 21, 2008). 2. adam w. culbertson, stephen j. valentine & stephen naylor, personalized medi­ cine: technological innovation and patient empowerment or exuberant hyperbole?, drug discovery world 18, 23 (2007). 3. nat'l cancer inst., office of biorepositories & biospecimen res., frequently asked questions, http://biospecimens.cancer.gov/resources/faqs/ [hereinafter national cancer institute](last visited feb. 16, 2008). 4. barbara j. evans, david a. flockhart & eric m. meslin, commentary: creating in­ centives for genomic research to improve targeting of therapies, 10 nature medicine 1, 2 (2004). 2008] a proposal for comprehensive biobank research laws 219 biobanks provide vital resources for this industry. biobanks collect, store, process, and distribute biological specimens and associated patient data to allow researchers to study the connection between molecular information and patients' clinical responses. 5 although scientists have long been pursuing re­ search on human biological materials, the recent mapping of the human genome coupled with improved information technology systems has created tremendous potential in biobank research. at least three legal issues may impede or slow down research from bio­ banks.6 first, the complex federal regulatory structure is ambiguous and inter­ nally inconsistent.7 second, there are public fears that genetic information could be used as a basis for discrimination in health care insurance, life insur­ ance, employment and education. 8 addressing these concerns requires a care­ ful examination of the legal landscape governing genetic information because several (although not all) research projects using biobanked samples perform genetic analyses. third, the law is unclear regarding ownership of human tis­ sues, which has led to bitter disputes and lawsuits and creates uncertainty among potential purchasers of the tissue who wish to create commercial prod­ ucts from them.9 the indiana general assembly may soon face pressure from both privacy advocates who wish to enhance patient protections, as well as those institutions or commercial sponsors who would like to streamline the process for collecting and using human tissues. examining the intersecting concerns regarding ge­ netic information and legal barriers to research and development will enable indiana to address these issues proactively and hasten the realization of transla­ tional research's promises of health care delivery. identifying areas of legal confusion and adopting a comprehensive legal framework for our state is cru­ cial to assisting the development of research discoveries originating from banked specimens. part ii of this article discusses the current regulatory and legal environ­ ment of genetic research, the implications for biobank-related research, and the ethical values that should guide state legislative responses. part iii outlines 5. national cancer institute, supra note 3. 6. this is not meant to suggest that legal issues are the only ones affecting the pace of research. there may be many other factors, including funding, but those are beyond the scope of this article. 7. barbara j. evans & eric m. meslin, encouraging translational research through harmonization of fda and common rule informed consent requirements for research with banked specimens, 27 j. legalmed. 119, 119 (2006). 8. norman-bloodsaw v. lawrence berkeley lab. 135 f.3d 1260 (9th cir. 1998); equal emp. opportunity comm'n v. burlington n. & santa fe ry. co., 2002 wl 32155386 (e.d. wis. 2002); louise mcintosh slaughter, genetic testing and discrimination: how private is your information? 17 stan. l. &pol'y rev. 67, 71 (2006). 9. gillian haddow et al., tackling community concerns about commercialization and genetic research: a modest interdisciplinary approach, 64 soc. sci. & med. 272, 272 (2007); see also radhika rao, genes and spleens: property, contract, or privacy rights in the human body?, 35 j. l. med. &ethics 371,372 (2007). 220 indiana health law r.evlew [vol. 5:217 state legislative efforts to address the shortcomings of federal regulations. part iv describes indiana's current statutory law on genetic research and offers a comprehensive solution which the indiana legislature may choose to adopt to address current legal uncertainties in a way that appropriately balances ethical values. this final section also includes a description of statutory provisions, which include a plan for the indiana state department of health to implement these legislative changes in a way that will encourage consistency among insti­ tutions and promote public support of translational research. ii. the current regulatory and legal environment and implications for biobank research part i of this article describes the federal regulatory framework governing research with banked specimens and highlights current inconsistencies between the "common rule," the "privacy rule" of the health insurance portability and accountability act of 1996 ("hipaa"), and food and drug administration ("fda") regulations. this section of the article discusses barriers to donation, including public fears of discrimination in employment and insurance benefits based on an individual's genetic information, and case law disputes related to ownership or disposition of donated specimens. this section also reviews ethi­ cal considerations that states should balance when considering the legal frame­ work for genetic research from biobanks, including promoting research advancements, respecting individual autonomy, and ensuring individuals' pri­ vacy and confidentiality. a. complex federal regulatory framework ambiguity and inconsistency plague the three primary federal regulations that govern biobanks. the common rule was created under the department of health and human services ("dhhs") to protect the rights and welfare ofhu­ man subjects and applies to all non-exempt research conducted by or supported by seventeen federal agencies. 10 tissue donors are considered human research subjects only when their tissue is collected for an identified research project and the donor's private information is readily identifiable by the investigator.11 this excludes any specimens that were collected in the past (for clinical or oth­ er research uses), and potentially excludes specimens collected for future uses (in biobanks) that are not readily identifiable to the researcher. however, the common rule does apply to identifiable coded samples collected, stored, and used in a biobank. informed consent is required for those research projects un10. see45 c.f.r. §§ 46.101 and46.102 (2005) (regulations that define the department of health and human services' research policies for protecting human research subjects). 11. 45 c.f.r. § 46.102 (2008). 2008] a proposal for comprehensive biobank research laws 221 less an institutional review board ("irb") determines that it meets the follow­ ing four conditions: (1) the research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not ad­ versely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out with­ out the waiver or alteration; and (4) whenever appropri­ ate, the subjects will be provided with additional pertinent information after participation. 12 the fda does not follow the common rule, but has its own set of regu­ lations intended to protect the rights, safety, and welfare of subjects in fda­ regulated clinical investigations. 13 unlike the common rule, its provisions do not distinguish between identifiable and non-identifiable tissues. the fda has similar rules regarding informed consent for human subjects, but it does not allow irbs to waive those requirements under any circumstances. 14 finally, the hip aa privacy rule covers research uses of "protected health information" ("phi"), which does not apply to the specimens them­ selves, but rather to the phi associated with specimens. 15 the rule's purpose is to protect individuals' privacy, confidentiality, and security interests in their phi. in general, hip aa' s privacy rule prevents a covered entity from disclos­ ing an individual's phi for research purposes without express authorization. federal guidance asserts that the "creation of a research database or repository, and the use or disclosure of phi from a database or repository for research, may each be considered a research activity under the privacy rule."16 both of those activities are thus subject to the privacy rule. hip aa governs coded or identi­ fiable data such as names, social security numbers and medical record numbers, and allows an individual to have the option to sign an authorization allowing the research institution to have access to this information. hipaa's privacy rule does not apply to data if it has been de-identified through statistically­ approved methods or if most personal identifying information has been re­ moved. however, some categories of information which link an individual to a particular population group (race, ethnicity, and socioeconomic status) may re­ main intact and still be considered legally de-identified. the privacy rule also permits the use oflimited data sets, which must be stripped of direct identifiers, 12. 45 c.p.r.§ 46.ll6(d) (2007). 13. 21 c.p.r.§§ 50, 56, 812 (2008). 14. evans & meslin, supra note 7, at 129. 15. 45 c.p.r. §§ 160.103 & 164 (2008). 16. dep't of health & human services, research reposll'or!es, databases, and the hipaa privacy rule (2004), available at http://privacyru1eandresearch.nih.gov/pdf/rese arch_repositories _final. pdf. 222 indiana health law review [vol. 5:217 but may include indirect identifiers such as birth date and treatment date. lim­ ited data sets must be accompanied by a data use agreement. 17 these regulations and associated guidance fail to provide researchers clear directives, particularly with regard to informed consent requirements. three examples typify the ensuing confusion. first, both the common rule and hip aa are unclear about whether subjects may give informed consent for fu­ ture, unspecified uses of their tissues, though the practice is widespread and not expressly prohibited. 18 second, the common rule and fda regulations are inconsistent regarding the ability ofirbs to waive the requirement for written informed consent. 19 third, there is conflicting guidance on whether the in­ formed consent statement may be used, in part, as a vehicle by which subjects waive future rights to profit from commercial products created from their tis­ sues.20 federal regulations provide ambiguous and inconsistent guidance, and they also leave a sector of the research community unregulated. states relying solely on federal regulations have no control over research that may be per­ formed by private institutions or corporations. private research institutions or repositories that do not receive federal funding are not bound by federal regula­ tions that govern human subject research and the confidentiality of personal health information. in addition, federally regulated researchers, hospitals, and providers sometimes sell or donate collected data and tissues to commercial research sponsors who make additional use of the data and materials that may not be consistent with the informed consent form originally signed by the sub­ ject. as one attorney with experience negotiating these agreements notes: 17. limited data sets are data sets stripped of certain direct identifiers that are specified in the privacy rule. these data sets may be used or disclosed only for public health, research, or health care operations purposes. they are not considered de-identified information under the privacy rule. before disclosing a limited data set to a researcher, a covered entity must enter into a data use agreement with the researcher, identi:l)ring the researcher as the recipient of the limited data set, establishing how the data may be used and disclosed by the recipient, and pro­ viding assurances that the data will be protected, among other requirements. see 45 c.p.r. § 164.514 (2006). 18. mark barnes & kate gallin heffernan, the 'future uses' dilemma: secondary uses of data and materials by researchers and commercial research sponsors, 3 med. res. law & pol'y 440, 442 (2004). 19. the common rule states that an irb can waive the requirement to obtain informed consent for research when four conditions are met. 45 c.p.r.§ 46.116(d). by contrast, the fda does not allow irbs to waive the informed consent requirement. 21 c.p.r. § 50.20 (1999). 20. the office of protection of research risks ("oprr"), now the office for human research protections ("ohrp"), has stated guidance that its "regulations are not intended to prohibit the informed subject from making a legitimate donation." letter from f. william dommel, jr., j.d., dir., div. of compliance, oprr, to merel p. glaubiger, univ. counsel, univ. of cal. at berkeley (mar. 21, 1989) (quoted in barnes & heffernan, supra note 18, at 445). the fda states that donors cannot waive rights as condition for study participation, and that the word "donation" should not be used because it connotes abandonment. food & drug admin., information sheets: guidance for institutional review boards and clinical investigators, 1998 update (1998). 2008] a proposal for comprehensne biobank research laws [o]ver the past years, massive quantities of subjects' da­ ta and biologic materials have been handed over to commercial sponsors that are largely unrestrained by contract or by regulation from doing with these data and tissue as they will-and they may even be free, from a legal perspective, to use subjects' data for marketing surveys and direct patient marketing.21 223 these research sponsors are subject to fda regulations only if they are using the research to support an fda application. otherwise, this use of data and tissues takes place without oversight from the irb of the institution where the tissue was collected, and without being regulated by the common rule, fda, or hip aa. commercial sponsors may voluntarily enter into clinical trial agreements ("cta") with institutions from which they acquire tissues, but those ct as rarely contain provisions relating to the privacy of personal health information.22 b. public fears of genetic discrimination vague and inconsistent federal regulation ofbiobank research likely has a chilling effect on researchers and investors, but it is the fear of genetic dis­ crimination that appears to have captured the public's imagination. statistics show that the public's willingness to allow employers or insurance providers access to their genetic testing results has decreased over the past few years. according to studies conducted by johns hopkins' genetics and public policy center, in 2002 eighty-five percent of individuals surveyed did not want em­ ployers to have access to their genetic information?3 that number increased to ninety-two percent by 2004. individuals also expressed similar opinions about health insurers' access to genetic information. in 2002, sixty-eight percent of surveyed individuals said their genetic information should be kept private from health insurers, and by 2004, this number rose to eighty percent.24 studies show that public apprehension derives from the possibility of discrimination or "misuse of genetic testing results by insurance companies or employers."25 currently, no federal prohibition exists to prevent discrimination based on genetic characteristics.26 some states have addressed the absence of federal 21. barnes & heffernan, supra note 18, at 442. 22. !d. 23. slaughter, supra note 8, at 71. 24. see id.; see also mary r. anderlik & mark a. rothstein, privacy and confidentiality of genetic information: what rules for the new science?, 2 ann. rev. genomics hum. genetics 40 l, 406-07 (200 1) (discussing focus group results of public support and willingness to contribute to genetic research). 25. yeal bregman-eschet, who controls our genetic privacy?, 23 santa clara computer & high tech. l.j. 1, 13 (2006). 26. the genetic information and nondiscriminatory act of 2008 (gina), h.r. 493, 224 indiana health law review [vol. 5:217 regulation by enacting statutory prohibitions related to genetic discrimination in employment or insurance contexts. "most states prohibit employers from re­ quiring genetic testing as a pre-employment condition or ban its use in health insurance altogether. ,m despite these statutory provisions, some statutes do not apply to discrimination in all insurance related contexts, protect individuals only as long as they are asymptomatic, or do not apply to insurance acquired through an employer. 28 state law also differs when defining what constitutes discrimination, or whether the law provides any legal remedy to the aggrieved individual. 29 some scholars, including henry greely, argue that widespread public fear is unfounded because few cases of genetic discrimination have been docu­ mented.30 however, people's concerns do not seem irrational in light of the nature of documented cases. in norman-bloodsaw v. lawrence berkeley laboratory, administrative and clerical workers filed suit arising from their employers' mandatory "employment entrance exams."31 the employer condi­ tioned employment on these "health evaluations," ordered the employees to contribute blood and urine samples, and then used those samples to conduct genetic testing to identify whether the potential employee had a sickle cell trait and other, non-genetic health conditions. 32 although norman-bloodsaw occurred prior to substantial state legislation intended to protect against genetic discrimination, a more recent case suggests 11 oth congress, passed the house and the senate on april 24th, 2008, and is awaiting presiden­ tial approval. it is expected that president bush will sign the bill into law. gina, first intro­ duced in 1995 as the genetic privacy and nondiscrimination act, prevents insurers from denying "insurance coverage or adjust[ing] premium rates paid by the individual or the group to which the individual belongs." and, in the context of employment, gina bars both public and private sector employers "from making employment related decisions based on genetic informa­ tion of applicants and employees." it would make it unlawful to refuse to hire or discharge em­ ployees based on genetic information. included in the gina definition of genetic information is an applicant's/employee's family history. see slaughter, supra note 8, at 74. 27. jonathan weems, a proposal for a federal genetic privacy act, 24 j. legalmed. 109, 117 (2003). 28. see mark rothstein, expanding the ethical analysis of biobanks, 33 j.l. med. & ennes 89, 90 (2005) (rothstein notes that some statutes would not prohibit the employer from "obtaining the results of genetic tests recorded in individual medical records."). but see henry greely, genotype discrimination: the complex case for some legislative protection, 149 u. pa. l. rev. 1483, 1488-99 (2001) (greely distinguishes that medical underwriting may only apply in circumstances where an individual purchases individually underwritten health care coverage. according to greely, the majority of americans (including medicare or medicaid beneficiaries) are covered without regard to their future risk). 29. some states prohibit discrimination based on genetic results only in some contexts, but allow genetic results to be used as a factor to determine actuarial risk or when allocating life insurance. cf n.y. civ rrs. law§ 79-l (mckinney 1997) andn.m. code ann.§ 24-21-4 (2005); see also weems, supra note 27, at 117-18. 30. greely, supra note 28, at 1490. greely also maintains that the rarity of genetic mark­ ers for diseases, the weakness of genetic markers in making predictions, the speed of employee turnover, and health care costs would prevent any recognizable financial incentives for employer insurance providers to discriminate on the basis of genetic testing results. 31. see norman-bloodsaw v. lawrence berkeley lab., 135 f.3d 1260, 1271 (9th cir. 1998). 32. /d. 2008] a proposal for comprehensne biobank research laws 225 genetic discrimination still may pose a concern. in 2001, the equal employ­ ment opportunity commission ("eeoc") filed a claim against the burlington northern and santa fe railway company ("bnsf") alleging americans with disabilities act ("ada") violations. the eeoc claimed that bnsf was re­ questing employees who developed carpal tunnel syndrome, a work-related in­ jury, to undergo a medical evaluation which included a diagnostic blood test for a genetic marker related to carpal tunnel syndrome. the unreported settlement agreement enjoined bnsf from requiring or requesting current or former em­ ployees to submit to genetic testing and ordered bnsf to return the genetic samples to the employees. 33 however, the agreement did not prevent bnsf from requiring a genetic test for future employees or as a condition of employ­ ment. discrimination based on genetic results may also be underestimated be­ cause it is difficult to document and prove. individual members of the public and employers may interpret results of potentially stigmatizing group-based genetic research and implicate other members of the group through unconscious or unspoken bias.34 unlike other instances of discrimination, individuals may not even be aware that their genetic information has been collected or is being used in a discriminatory manner. c. ambiguity regarding tissue ownership issues of control arise when individuals' biological specimens and sam­ ples are used by researchers, and the use does not conform to the individual's expectations or to the actual informed consent agreement.35 members of the public may also believe that they "own" their genetic material; thus, an institu­ tion's or court's assertion to the contrary is seen as an assault on privacy or dig­ nity. 36 many of the current informed consent statements used during the 33. equal emp. opportunity comm'n v. burlington n. & santa fe ry. co., no. 02-c0456, 2002 wl 32155386 (e.d. wis. may 8, 2002); see also press release, eeoc settles ada suit against bnsf for genetic bias (april 18, 2001), available at http://www.eeoc .gov/press/4-18-0 l.html. 34. rothstein, supra note 28, at 91; see also alice hsieh, a nation's genes for a cure to cancer: evolving ethical, social, and legal issues regarding population genetic databases, 37 colum. j.l. & soc. probs. 359,410 (2004). 3 5. see jasper bovenberg, the new case for an inalienable property right in human biological material: empowerment of sample donors or a recipe for a tragic anti-commons? 1 scrjpt-ed 545 (2004), available at http://www.iaw.ed.ac.uk./ahrc/script-ed/issue4/bovenberg .asp; see also haddow et al., supra note 9. 36. see marina whelan, what, if any, are the obligations of the u.s. patent office?: a closer look at the biological sampling of indigenous populations, 14 duke l. & tech. rev. (2006) available at http://www.law.duke.edu/joumals/dltr/articles/2006dl troo 14.html. whe­ lan notes that the un has supported the view that individuals should have property rights in their biological material and should not be forced to assimilate to the framework adopted by some researchers. unlike the un's view, henry greely believes that once genetic material is separated from the body, the individual no longer shares a relationship with the genetic material. i d., citing henry t. greely, symposium: international health law, the control of genetic 226 indiana health law review [vol 5:217 procurement of genetic specimens explicitly state that the donor has no express interest or right to their genetic sample following donation.37 some tissue donors wish to place limitations or impose a governance structure on the institution to limit the scope, type, or location of the research as a condition of donation. empirical research studying public attitudes regarding hypothetical research scenarios as well as actual donors' attitudes indicates that certain members of the public value the following factors, by being able to: ( 1) authorize the use of their genetic sample for only a particular type of research; (2) prevent the genetic sample from being used for other types of research not authorized; (3) limit where the research is being conducted (i.e. authorizing research only at this specific institution, research only by public or non-profit corporations, research only in the united states); or ( 4) limit the time period for usage.38 as legal scholar radhika rao has noted, courts addressing ownership dis­ putes have generally refused to recognize an individual's property right in ex­ cised specimens, but do recognize an institution's right to maintain, use, or develop products resulting from the specimens. 39 there are several notable ex­ amples of these conflicts. moore v. regents of the university ofcalifornia40 is the classic case, in which john moore, a patient who underwent treatment for leukemia at the ucla medical center, brought an action against his physician and the ucla board of regents when he discovered that they created a pat­ ented cell line from his tissues without his knowledge or consent. the moore court set what became a very influential judicial precedent when it held that moore's excised tissues were not his property, but belonged to the researchers who used them to develop celllines.41 research: involving the "groups between," 33 hous. l. rev. 1397, 1414-15 (1997). 37. gary marchant, property rights and benefit-sharing for dna donors? 45 jurimetricsj. 153, 155 (2005). 38. paul helft et al., cancer patients' attitudes toward future research uses of stored human biological materials, 2 j. empirical res. hum. res. ethics 15, 18-19 (2007). helft et al. studied the attitudes of cancer patients who had contributed tissue samples to a tissue bank. helft found that respondents were more likely to disagree with using their stored tissues for future studies on diseases other than their type of cancer. respondents were also less likely to be willing to allow their tissue samples to be used by researchers not affiliated with local re­ searchers. haddow et al. 's interviewed focus groups to obtain public opinion s relating to gen­ eration scotland, an arm of u.k. biobank. although this study was conducted in scotland, several of the responses are relevant and echo concerns arising in u.s. judicial disputes. several respondents stated that they would have reservations about donating specimens for mental health research, and viewed this category of research as potentially stigmatizing. respondents also noted that they felt apprehension relating to research uses not specifically authorized, stat­ ing that all research uses should be disclosed and the specimens should only be used for the purpose to which the donor specifically consents. gillian haddow eta!., generation scotland preliminary consultation exercise 2003-2004: public and stakeholder views from focus groups and interviews, available at http://l29 .215.140.49/gs/documents/initialconsultation.pdf; see also haddow et al., supra note 9. 39. rao, supra note 9, at 372. 40. moore v. regents of the univ. of cal., 793 p.2d 479 (cal. 1990). 41. the majority reasoned that recognizing a property right would unnecessarily hinder medical research. see bregman-eschet, supra note 25, at 25 for a full discussion of arguments against granting individuals' property rights in their biological specimens and genetic informa2008] a proposal for comprehensive biobank research laws 227 greenberg v. miami children's hospitaf2 followed moore's nonbinding decision, rejecting recognition of an individual property right in excised speci­ mens or in a derivation of one's gene sequence. in greenberg, donors of hu­ man tissue and fluids, physicians doing research on canavan disease, and private organizations sued physician, dr. reuben matalon, a physician who obtained and licensed a patent for a gene causing the disease. consistent with moore's rejection of individual interests, greenberg held that the gene patent for canavan disease conferred a property right to researchers and hospitals, but not to the donors whose dna contained this gene.43 greenberg also implicitly rejected the equity concern of ensuring that specimen donors can benefit or ob­ tain access to any research discoveries resulting from their donations. in this case, the individuals and family members who had donated tissue to dr. mata­ lon to study canavan disease were in some instances unable to obtain the screening test dr. matalon developed due to its high cost.44 washington university v. catalona45 followed the greenberg ownership precedent, holding that once an individual donates specimens to a research in­ stitution, the individual no longer has any legal property claim to the specimens that would allow the individual to redirect or transfer the specimens.46 in cata­ lona, washington university sought a court's declaration that it owned speci­ mens collected for prostate cancer research so that it could prevent the donors of those specimens from transferring them to another research facility with a particular researcher, dr. catalona.47 the court in catalona also affirmatively supported the research institution's right to the specimens over the rights of individual researchers. 48 the court in tilousi v. arizona state board of regents49 similarly de­ clined to recognize the ability of an individual to control the use of a specimen after donation, and it resolved questions related to research breadth in favor of the institution.50 in tilousi, members of the havasupai tribe objected to the researchers' use of genetic samples that they donated specifically for diabetes research, but which researchers used to study schizophrenia and inbreeding. 51 according to members of the tribe, they would not have initially provided the donations if they had known that the researcher would carry out stigmatizing research to which they had not consented. tion; see moore v. regents of the univ. of cal., 793 p.2d at 492-495; see also rao, supra note 9, at 372. 42. greenberg v. miami children's hosp. res. inst., 264 f.supp.2d 1064, 1074-75 (s.d. fla. 2003). 43. ld.; see also rao, supra note 9, at 372. 44. greenberg, 264 f .supp.2d at 1067. 45. washington univ. v. catalona, 490 f.3d 667, 675 (8th cir. 2007). 46. jd. at 667,675-77. 47. !d. at 672. 48. !d. at 674-75. 49. !d. 50. tilousi v. ariz. state bd. of regents, order no. 04-cv-1290-pct-fjm (2004). 51. id. 228 indiana health law review [vol. 5:217 currently, only one case departs from judicial precedent favoring institu­ tions, but the outcome is consistent with prior decisions in moore, greenberg, and catalona in that the court seeks to maximize research using donated spe­ cimens. in comyn v. fifty-two members of the schoppa family,52 members of the schoppa family sought to ensure that the specimens of brains from their deceased family members and other genetic samples were actually put to con­ structive use for alzheimer's research. 53 in this case, the university to which they donated the tissues had halted their research efforts. while comyn was more favorable to the plaintiffs, the court's decision only held that the plaintiffs had standing to bring their claim for enjoining the destruction of the materials that they or their family members had donated. 54 as the preceding cases demonstrate, current jurisprudence rejects several of the issues some members ofthe public believe to be important, such as the recognition of an individual's ability to place limitations or conditions on his or her donation. 55 additional concerns arise in the context of downstream products. donors to biobanks generally want assurances that they will benefit from any screening tests, treatments, or medications developed through research using their dona­ tions, and they do not always trust the institution to ensure reasonable access. once researchers have patented a cell line, the current legal framework allows the patent holder to sit on the patent where the holder would not develop useful continuing research of the cell line or develop a product such as a genetic screening test for the patented cell line. a patent holder's exclusionary rights would also prevent other researchers from using the patented cell line to de­ velop further technologies. 56 in several situations where researchers have patented a downstream prod­ uct developed from donated biological materials, the donors themselves have been unable to benefit from the technological advancement. 57 this exclusion of 52. comyn v. fifty-two members of the schoppa family, 70 s.w.3d 895 (tx. ct. app. 2001). 53. /d. at 900-0l. 54. the court in cornyn did not directly mle on the issue of whether the donors could actually prevent the destruction of their tissues, nor did the court rule that the donors could re­ quire constructive use of their tissues. !d. 55. rather than participating in research through the current institutional framework like in tilousi, pxe created their own contractual model whereby they created a biobank and enter into written agreements with researchers who submit to pxe's conditions. see kevin ober­ dofer, the lessons of greenberg: informed consent and the protection oftissue sources' re­ search interests, 93 geo. l.j. 365, 390-91 (2004). 56. pilar ossorio proposed to address this potential technological stall by stipulating that if patent holders sat on their patent, they could be legally required to license their patents to entities that would constructively develop further technology. pilar ossorio, the human ge­ nome as common heritage: common sense or legal nonsense? 35 j.l. med. & ernrcs 425, 435 (2007). 57. see lori andrews, harnessing the ben4fts ofbiobanks, 33 j.l. med. & ethics 22,22 (2005). 2008] a proposal for comprehensive biobank research laws 229 benefits poses a serious concern to previous donors and, if not addressed, could hinder future willingness to donate. 58 d. implications of the current regulations on biobank research although the current legal and regulatory environment for biobank re­ search is confusing and sometimes inconsistent, there are some positive impli­ cations for states that choose not to legislate further, but to rely on the legal status quo. as noted above, current regulatory ambiguities have been inter­ preted in favor of the research institution and allow institutions greater control over donated specimens. federal regulations may be revised, and those revi­ sions might reconcile the current inconsistencies. however, the status quo also has troubling implications for biobank research. the regulatory ambiguities and inconsistencies hinder efficiency by chilling some researchers and irbs, who would be more likely to engage in research or approve protocols if there were clear guidance regarding how to do it legally. long-term public support may be adversely affected when people learn about the amount of research that takes place outside federal regulatory supervision and irb oversight. the sta­ tus quo also fails to allay the public's fears regarding genetic discrimination. finally, the uncertainty about tissue ownership potentially decreases investment in biobank-related research due to fears oflitigation over downstream products. some disease advocacy groups, distressed over the ways in which courts have resolved these disputes, have turned to negotiating contracts with researchers that give them intellectual property rights in commercial products; such ad hoc contract negotiations, however, undoubtedly have an adverse effect on effi­ ciency. e. ethical considerations states considering whether to accept or attempt to change the status quo regarding biobank research may wish to consider the question in the context of three important ethical norms: the value of advancing medicine and improving health; respect for autonomy (or respect for persons); and the protection of pri­ vacy and confidentiality. in typical biomedical research, the process of obtain­ ing informed consent (or refusal) requires "disclosure[s] about the purpose, risks, benefits and protections for confidential information [which] provide[ s] participants with the opportunity to exercise autonomy by choosing to partici58. one way to address this concern is to create a regulatory provision that could ensure donors have free access to tests, treatments, or medications developed from their donations. see melanie baird, when and why does what belong to whom? a proposed model for the interna­ tional protection of human donors of biological material, can.-u.s. l.j. 331, 345 (2006). iceland's agreement with decode genetics contained a similar provision which allowed ice­ landers free access to drugs developed by decode for the duration of the patent period. see rao, supra note 9, at 375. 230 indiana health law review [vol. 5:217 pate in the study of a drug or device."59 the presentation of this information allows research participants to weigh the relative importance of these some­ times conflicting values themselves. the traditional paradigm is complicated in cases of research originating in biobanks, which are "research platforms that may involve hundreds of different research initiatives spread over a long period oftime."60 it therefore becomes difficult, expensive, and sometimes impossible to obtain informed consent for specific projects. in addition, the vast number of collaborative arrangements between the researchers who first collect data or tissues, and the subsequent users of that information, severs the relationship between researchers and tissue donors, and sometimes removes the research from federal regulatory oversight. the first important value is that of advancing medicine and improving health, which can be best accomplished by laws and procedures that maximize the efficiency of the process of collecting and using biological samples and data, and allows the greatest access possible to richly annotated samples. the promise of this kind of research extends to nearly every area of medicine, from personalized clinical therapy to broad-based public health efforts, and it is also presumed to serve the economic interests of the community by creating jobs. however, it is possible that an overly vigorous pursuit of research efficiency can backfire, particularly if this goal is pursued in ways incompatible with re­ spect for individual choice and protection of donors from potentially discrimi­ natory uses of their information. for example, researchers collecting biological samples were seen as exploitative of indigenous peoples in alaska. 61 alaska responded with a set of laws so protective of donors that it is unlikely that alaska would ever be capable of fostering a robust genetic research agenda. 62 the second important value is respect for autonomy, which concerns the long-standing legal and ethical norm that individuals have the right to make important choices about their own lives. a robust understanding of respect for autonomy focuses on the well-informed choices of individuals with regard to the research uses of information and/or tissue samples. for instance, individu­ als may affirmatively choose to participate in certain kinds of research (such as breast cancer or alzheimer's disease) or purposefully avoid potentially stigma­ tizing research or research that is morally objectionable for more idiosyncratic reasons (such as religious or philosophical objections to certain practices). some argue that the robust conception of autonomy is not relevant in the case of research involving tissue samples because the donors of those samples (and the corresponding information related to them) are not human research subjects 59. timothy caulfield, russell brown, & eric m. meslin. challenging a well estab­ lished consent norm? one time consent for biobank research, 4 j. int'l biotech. l. 69, 70 (2007). 60. !d. at 70. 61. brett shelton, consent and consultation in genetic research on american indians and alaska natives, indigenous peoples council on biocolonialism, http://www.ipcb.org/pub lications/briefing__papers/files/consent.html (last visited mar. 17, 2008). 62. alaska stat. §§ 18.13.010 & 18.13.030 (2008). 2008] a proposal for comprehensive biobank research laws 231 in the classic sense.63 however, for those who believe that respect for auton­ omy continues to be important after tissue collection, there is a kind of ethical zero-sum game; increasing individual control decreases the efficiency and value of the genetic research that can be done. a third important ethical value implicated by genetic research is the re­ sponsibility to protect the privacy and confidentiality of individuals' health in­ formation in order to guard against insurance and employment discrimination. this has been the focus of many state genetic privacy laws.64 georgia's state laws, for example, are structured to limit the use and availability of genetic in­ formation and prevent certain disclosures of genetic information to third par­ ties.65 iii. state approaches to federal regulatory inconsistencies ln genetic research part iii describes how some state legislatures have addressed the inconsis­ tencies in federal law. this portion of the article first describes state legisla­ tures' definitions of legal elements involved in the process of collection, research, usage, and storage of specimens and genetic information. next, this section describes how several states have adopted a mutually exclusive ap­ proach to legislation: either increasing research efficiency by decreasing auton­ omy and privacy for individual donors or increasing individual protections at the expense of research efficiency. a. state legislative responses: an overview of legal elements several states have attempted to clarify the uncertainty in the federal regu­ latory framework by defining relevant terms related to the biobanking and ge­ netic research process. the following is a summary of several existing state laws relating to the collection ofbiological specimens or genetic samples, stor­ age of genetic samples, and retention of genetic samples and genetic informa­ tion. these provisions do not apply to genetic testing or analysis conducted in other contexts such as criminal identification purposes, paternity testing, or newborn screening. 66 63. greenberg v. miami children's hosp. research inst., 264 f.supp.2d 1064, 1069 (s.d. fla. 2003). 64. see ga. code ann.§§ 33-54-1 to 33-54-8 (2007); la. stat. ann. 22:213.7 (2008); but see n.m. stat. ann. § 24-21-3 (west 2008). 65. !d. 66. it is important to note that states may differ in the way they define basic terms such as "dna samples" or "genetic information", and those definitions may affect the way a law is in­ terpreted. for example, oregon defines a dna sample as the biological specimen collected for the purpose of extracting and analyzing dna as well as the actual dna extracted from the sam­ ple. this definition affects how one would interpret a law which gives the requirements to col­ lect a dna sample because that collection could mean obtaining a blood sample or extracting 232 indiana health law review [vol. 5:217 1. personal access to dna results if a physician or researcher is performing a genetic test or analysis, some states include provisions which describe how that information may be provided to the individual. for instance, when signing the informed consent form to ob­ tain a genetic sample and analysis, delaware requires that the person obtaining the sample provide the individual with the results of the analysis unless the in­ dividual directs otherwise.67 some states also require that informed consent forms contain a request provision which allows an individual who contributed a sample for dna analysis to request, inspect, or obtain his or her own genetic records.68 2. lriformed consent and exemptions states vary widely with regard to informed consent requirements for the collection, use, or retention of a genetic sample and genetic information. sev­ eral states have exempted persons from obtaining informed consent before pro­ curing genetic information for medical repositories or medical and scientific research. new mexico provides that an individual's dna, genetic information, or a genetic analysis may be obtained, retained, transmitted, or used without a person's written informed consent pursuant to federal regulations if that infor­ mation is for a medical repository or registry, or medical or scientific research. 69 nevada law also provides a similar exception, which states that if a researcher obtains the genetic information for use in a study where the identities of the individuals are not disclosed to the person conducting the study, then the indi­ vidual's informed consent to obtain that genetic information is not required. 70 oregon has created an "opt-out" notification system for researchers to col­ lect coded or identifiable samples without obtaining written informed consent provisions. a researcher must notify the individual that his or her biological specimen or individual identifiable health information will be used for coded or anonymous research, and that the researcher may use the genetic sample and genetic information unless the individual responds to the notice indicating that he or she does not want the sample or information used.71 researchers are not required to obtain any consent for collection or use of a dna sample or genetic information which is de-identified or unidentified; they are also not required to provide individual notice when samples will be de-identified.72 alaska law requires a researcher to obtain written informed consent before collecting an individual's dna sample, performing a dna analysis on that the dna in a laboratory setting. 67. del. code ann. tit. 16, § 1220 (2008). 68. alaska stat.§ 18.13.010 (2008); del. code ann. tit. 16, § 1223 (2008); nev. rev. stat.§ 629.141 (2008); or. rev. stat.§ 192.537 (2008). 69. n.m. stat. ann.§ 24-21-3 (west 2008). 70. nev. rev. stat.§ 629.151 (2003). 71. or. rev. stat.§§ 192.537-192.538 (2003). 72. or. rev. stat.§ 192.537 (2008). 2008] a proposal for comprehensive biobank research laws 233 sample, retaining a dna sample or the results of the dna sample, or disclos­ ing the results of the dna analysis. 73 some state laws specify that separate informed consent must be obtained for each action. delaware law outlines spe­ cific elements to satisfy the informed consent requirements.74 to obtain con­ sent for collection of a non-anonymous sample and to obtain a genetic analysis, delaware requires the informed consent form to list a description of which ge­ netic tests will be performed, their purposes, potential uses, limitations, and the meaning ofthe results, as well as providing the individual with the test results unless the individual directs otherwise. delaware law also requires that there­ tention portion of the informed consent form include a description of the ge­ netic information retained and its potential uses and limitations. to disclose genetic information, the statute requires that the informed consent form provide an additional description of the information released and to whom it may be released. 75 3. retention and destruction of dna samples and genetic information states vary widely with regard to researchers' ability to retain an individ­ ual's genetic sample and information, as well as whether a researcher is re­ quired to destroy an individual's genetic sample upon request. several states specify the disposition of the genetic samples and/or genetic information in cir­ cumstances where an individual has not specifically requested sample destruc­ tion. in nevada, when an individual does not specifically request destruction of genetic information, the researcher must destroy the genetic information either after the completion of the study or after the individual withdraws from the study.76 in new mexico and oregon, a dna sample from an individual that is used for non-anonymous research must be destroyed upon the completion of the project or if the individual withdraws from the project.77 some states, however, include a provision for continued use and retention of the genetic information and sample. nevada and oregon law allows re­ searchers to retain genetic information after completion or withdrawal from the study by obtaining specific authorization from the individual. 78 the new mex­ ico statute also stipulates that an individual's genetic samples and genetic in­ formation must be destroyed at the individual's request, but this provision contains many significant exceptions. the individual's right to request destruc­ tion does not apply where an individual's samples are used by an irb-approved research protocol, if the samples are being used by an authorized medical repo73. alaska stat.§ 18.13.010 (2006). 74. del. code ann. tit. 16, § 1220 (2008). 75. id. 76. see nev. rev. stat. § 629.161 (2000). 77. see n.m. stat. ann.§ 24-21-5 (west 2008); or. rev. stat.§ 192.537 (2003). 78. nev. rev. stat.§ 629.161 (2000); or. rev. stat.§ 192.537 (2003). 234 indiana health law review [vol. 5:217 sitory or registry, or for other medical or scientific research. 79 oregon law simi­ larly recognizes an individual's general right to request destruction of a dna sample, but specifies that this right does not apply to samples retained for coded or anonymous research samples collected from an individual who did not pre. l 80 vlous y opt-out. alaska and delaware statutes further clarify that a person must obtain in­ formed consent from an individual to retain a genetic sample or genetic infor­ mation. 81 in delaware, however, consent is not required if the sample is used for anonymous research. 82 delaware law requires researchers to comply with an individual's request to destroy genetic samples, unless retention has been previously authorized by the individual or the sample is used for anonymous research where the identity of the individual will not be released.83 in nevada, if an individual requests that a researcher destroy genetic information, the re­ searcher must comply with that request.84 4. disclosure of results state laws vary regarding the disclosure of genetic information to third parties, the process of disclosure, and limitations on disclosure. new mexico law expressly prohibits an insurer from discriminating against a person or a member of the person's family on the basis of genetic analysis, genetic informa­ tion, or genetic propensity. 85 despite this provision, new mexico does not pro­ hibit the use of genetic analysis, genetic information, or genetic propensity by an insurer in the ordinary course of business in connection with life, disability income, or long-term care insurance if the information is based on sound actu­ arial principles. 86 georgia law requires that an individual's genetic information be kept con­ fidential and may be released only to the individual and specific persons author­ ized by the individual. 87 when a researcher obtains informed consent for the dna analysis of the sample, the law specifies that this consent only allows the researcher to use the genetic information for the authorized research study, eli­ minating the possibility that the researcher could share or transfer the individ­ ual's genetic information to a party outside of the research study.88 several states impose conditions for the release of genetic information to parties like insurance providers and specify actions prohibited by insurers who 79. see n.m. stat. ann.§ 24-21-5 (west 2008). 80. or. rev. stat.§ 192.537 (2003). 81. alaska stat.§ 18.13.010 (2006); del. code ann. tit.l6, § 1222 (2008). 82. !d. 83. del. code ann. tit. 16, § 1222 (2008). 84. nev. rev. stat. § 629.170 (2000). 85. n.m. stat. ann.§ 24-21-4 (west 2008). 86. see n.m. stat. ann.§§ 24-21-3-24-21-4 (west 2008). 87. ga. code ann.§ 33-54-3 (2008); accord alaska stat.§ 18.13.010 (2008). 88. ga. code ann. § 33-54-6 (2008). 2008] a proposal for comprehensne biobank research laws 235 obtain this information. several states allow an individual to release his or her genetic information to insurers by means of an informed consent provision. delaware law, for example, requires consent for the release of genetic informa­ tion to an insurer, and the insurer can retain the information only for the spe­ cific purpose and specific length authorized by the individual. 89 georgia law prohibits insurers from using released genetic information for any non­ therapeutic purpose.90 even some of the state laws that are framed as preventative measures against disclosure of genetic information contain significant exceptions. ore­ gon's opt-out scheme allows any health care provider covered under hip aa to disclose genetic samples or information for coded or anonymous research so long as the provider provides the individual with notice of the research and an opportunity to decline participation.91 if the health care provider is not a hipaa-covered entity, the health care provider is not required to inform the individual of plans to disclose the genetic sample or protected health informa­ tion for coded or anonymous research process. 92 oregon law also provides that the publication of an individual's genetic information or identity does not con­ stitute a disclosure if it is not due to willful neglect and if it is corrected before a third party learns of it or performs a genetic test on a tissue sample. 93 florida law requires the individual's consent to disclose the results of ge­ netic information, but the law also states that the health care provider must pro­ vide the individual with notice if the genetic information is used in any decision to grant or deny any insurance, employment, mortgage, loan, credit, or educa­ tional opportunity, suggesting that florida law allows these decisions to be based on genetic information. 94 5. property interests few state laws address ownership issues related to genetic material or in­ formation. five states define dna analysis test results as the exclusive prop­ erty right of the individual. 95 florida clarifies that this property right applies even if the results of the dna analysis are held by a private entity. 96 oregon originally included in its law a definition of genetic information as the property of the individual, in "an attempt to solve several legal problems: providing guid­ ance to the courts as to the nature of a person's rights to genetic information, 89. del. code. ann. tit. 16, § 1220 (2008). 90. ga. code ann. § 33-54-4 (2008). 91. see or. rev. stat.§ 192.538 (2003). 92. see id. 93. or. rev. stat.§ 192.539 (2003). 94. fla. stat. ann. § 760.40 (west 2008). 95. see alaska stat.§ 18.13.010(2006); colo. rev. stat. ann.§ 10-3-1104.7 (west 2008); fla. stat. ann. § 760.40 (west 2004); ga. code ann. § 33-54-1 (2008); la. rev. stat. ann. 22:213.7 (2008). 96. see fla. stat. ann. § 760.40 (west 2004). 236 indiana health law review [vol. 5:217 allowing family ownership of genetic information, and implying a remedy for a blood relative of an individual who suffers discrimination."97 it was later re­ pealed because, according to a pharmaceutical company, it negatively impacted research due to concerns that "a subject of research might later assert a claim to own the fruits of research and that a transfer of those rights to a researcher might be unenforceable."98 in addition to the results of the dna analysis, alaska is currently the only state to have a law that defines the actual dna sample as the "exclusive prop­ erty'' of an individual. this severely or completely limits the possibility of us­ ing one's genetic sample as the basis for a commercial product development.99 6. civil and criminal liability states vary as to how, if at all, they address violations ofthe provisions discussed above. states recognizing a person's liability for violating these stat­ utes vary with regard to which individual (or individuals) has standing to bring a claim, who may be named as a breaching party, what applicable law an indi­ vidual may use to claim a breach or injury, and what damages the law makes available to complaining parties. "standing" is defined as "a person's right to make a legal claim or seek judicial enforcement of a duty or right."100 standing refers to who can claim an injury by a physician or researcher's violation of the statutes relating to genetic samples and information. some states, such as alaska, define standing broadly, stating that "a person" may bring a claim. 101 new mexico law specifies that "a person whose rights have been violated under the provisions" has standing, 102 but it also permits the attorney general or dis­ trict attorney to initiate a civil action against a person for violations.103 nevada defmes standing so that it includes "any person who suffers an injury as a result of the disclosure," explicitly expanding "standing" to more than the original genetic sample contributor. 104 the term "breaching party'' refers to a person or entity who owes a legal duty to another person, and in violating that duty, has caused injury or harm to another person.105 in this context, the breaching party may be the physician, researcher, or institution that has a duty to the patients and participants to up­ hold and follow state laws when obtaining and using genetic samples and in­ formation. if physicians or researchers do not follow these requirements, then 97. history of oregon's genetic privacy law, http://egov.oregon.gov/dhs/ph/gene tics/docs/history_ of_ oregon2 _ 07b.pdf, 2005, at 2 (referencing s.b. 276). 98. /d. 99. alaskastat. § 18.13.010(2006). 100. black's law dictionary 1442 (8th ed. 2004). 101. alaska stat. §18.13.020 (2006). 102. n.m. stat.§ 24-21-6(b) (2008). 103. n.m. stat.§ 24-21-6 (2000). 104. nev. rev. stat.§ 629.201 (2008). 105. see generally "breach," black's law dictionary, supra note 100, at 200. 2008] a proposal for comprehensive biobank research laws 237 they are breaching this duty. many of the states that allow civil relief define breaching party as "any individual" or "any person" who retains, obtains, or discloses an individual's genetic sample or genetic information. 106 states vary on the level of intent, if any, required to show a violation of these laws. gener­ ally, intent is defined as a person's state of mind accompanying a certain act. this mental state may range from negligence to knowingly and willfully violat­ ing a law. several states rely on a strict liability standard with regard to intent, where the law recognizes a violation regardless of the person's state of mind. for example, laws in alaska and new mexico specify that any violation of their statutes constitutes a potential claim. 107 delaware law requires an element of intent, and the individual bringing the claim must demonstrate that the person "willfully" violated the statutory provisions. 108 in oregon, there is a tiered sys­ tem based on levels of the alleged violator's knowledge and intent, ranging from inadvertent violations to those knowingly committed.109 oregon is the only state that specifically allows the breaching party to use an affirmative defense. 110 an "affirmative defense" is an argument which al­ lows the breaching party to defeat the injured party's claim, even if all of the alleged violations are true. 111 for example, a patient may allege that a re­ searcher disclosed the patient's genetic sample and information to a third party, which would theoretically violate the law. nevertheless, even if the researcher did breach a duty, the researcher could demonstrate that he or she took action to correct the violation. a court may accept that the researcher satisfied the re­ quirements of an affirmative defense by taking corrective action and rule in fa­ vor of the researcher. this provision would allow a researcher or institution opportunities to correct violations, which would decrease a patient's potential success in legal disputes. if a court finds that a person has violated the provisions of the law, the in­ jured party may be entitled to damages. damages are usually monetary in na­ ture, paid by the breaching party to the injured to compensate that person for his or her injury. some states specify the type of damages or the amount of monetary damages an injured individual may recover if successful. nevada law states that an individual is entitled to actual damages, 112 while oregon's tiered system specifies dollar amounts, which the court may award for each particular violation. 113 some states, such as georgia, mandate breaching insurers to pay actual damages or the court may order the insurer to provide the individual in­ surance coverage under the same terms had the violation not occurred. 114 106. id. 107. alaska stat.§ 18.13.020 (2006); n.m. stat.§ 24-21-5 (2008). 108. del code ann. tit. 16, § 1227 (2008). 109. or. rev. stat.§ 192.541 (2003). 110. see id. 111. black's law dictionary, supra note 100, at 451. 112. nev. rev. stat.§ 629.201 (2000). 113. or. rev. stat.§ 192.541 (2003). 114. ga. code ann. § 33-54-8 (2008). 238 indiana health law review [vol. 5:217 very few states recognize criminal liability for violations of the laws ref­ erenced above. 115 florida law states that a violation constitutes a class a mis­ demeanor, 116 while the laws in alaska and oregon specify that a level of intent is required to find a violation, such as the person knowingly or recklessly viol d h d. . . !!7 ate t e correspon mg statutory provisions. b. state legislative strategies to protect donors or promote research efficiency state legislatures that appear to have a conscious strategy regarding ge­ netic research tend to pass laws that, in combination, either promote research efficiency, potentially at the behest of medical and pharmaceutical interests, or to enhance donor protections. 1. state laws that increase protections for tissue donors some states have passed legislation that treat the collection of tissue and its related information just like other kinds of human subjects research. this means that informed consent is required to obtain an individual's samples and to perform genetic tests for research, but no attempts are made to streamline the consent procedures or requirements for the unique difficulties in research in­ volving biobanks and data repositories. several states follow the traditional human subjects research model of ob­ taining informed consent for every collection and subsequent research proce­ dure, yet the states provide exceptions for anonymous research. for example, delaware requires a physician or researcher to obtain the patient's written in­ formed consent for the sample collection, sample genetic analysis, and storage of the genetic sample, if the research is not anonymous. 118 florida defines a patient's genetic information as his or her personal property, although this ele­ ment of the law focuses on protecting the patient's confidentiality and prevent­ ing unauthorized disclosure and does not confer rights to direct the use of tissue or profit from commercial products. 119 this model protects patients and donors from unwanted collection or unauthorized genetic research of their samples, but may not allow for maximum sample collection if the repository wishes to con115. see infra, notesll3-115 and accompanying text. 116. fla. stat. ann.§ 760.40 (west 2004). 117. alaska stat.§ 18.13.030 (2006); or. rev. stat.§ 192.543 (2003). 118. del. code ann. tit. 16, § 1221-1222 (2008). 119. see greenberg v. miami children's hosp., 264 f.supp.2d 1064, 1069 (s.d. fla. 2003). the court in greenberg cites section 760.40 of the florida statute, which states that individuals contributing tissue for researchers do not relinquish ownership of the results ofthe analysis. the court limited the application of this provision by holding it did not extend to any right relating to the development of commercial products, because the donors severed their in­ terest upon donating their tissues. greenberg, 264 f.supp.2d at 1069. 2008] a proposal for comprehensive biobank research laws 239 duct coded research. 120 ensuring full informed consent for the collection of the biological specimen and all its genetic research uses may be costly, time con­ suming, and logistically complicated. some donors may also be hesitant to au­ thorize use of their samples if they are re-contacted by researchers, which could result in a loss of samples for continued use. oregon has enacted laws that provide even greater protections for indi­ viduals. oregon's laws are generally consistent with federal regulations. there is, however, one important exception: individuals must have the opportunity to opt-out of anonymous or coded genetic research otherwise allowable in some circumstances under federallaw. 121 if patients do not respond to the notice in the allotted time period of six months to indicate that they do not want the sam­ ple or information used, then the physician or researcher may retain and use the sample and information. if patients do not choose to opt-out, the tissues may be used for anonymous or coded research approved or exempted from approval by an irb. interestingly, although oregon's law gives patients more protections than the federal regulations, much of the public response has been negative, because the public has realized for the first time that their health information or biological specimens can be used without their consent. this is one gap in edu­ cation that oregon's advisory committee on genetic privacy and research ("oregon's advisory committee") is attempting to remedy. 122 since this re­ quirement became law in oregon, it has caused some confusion in terms of how providers should present this information, and how laboratories can track sam­ ples of those who have opted out. 123 the donor opt-out model requires an in­ formed public to work properly, and oregon has created an advisory committee on genetic privacy and research that has developed educational tools for irbs, researchers, and health care consumers. 124 alaska is the most restrictive state with regard to the collection and stor­ age of a patient's genetic sample and information and strongly favors individual rights. alaska is the only state which defines an individual's genetic sample as his or her personal property. alaska and florida follow the consent require­ ments imposed in states like delaware, but importantly require informed con120. some states do not require consent for research using anonymous specimens. al­ though this is not recognized by federal law as human subjects research, it does not technically protect patients from all unwanted collections and uses of their specimens. see del. code ann. tit. 16, § 1227 (2008); n.y. c!v. rights law§ 79-1 (mckinney 1997). but see alaska stat.§ 18.13.010 (2006); fla. stat. ann.§ 760.40 (west 2004)(language of statutes do not contain exemptions to use anonymous specimens for genetic research). 121. or. rev. stat.§ 192.535(l)(b) (west 2007). 122. report to the legislature assembly, advjsory committee on genetic prjv acy and research 6 (mar. 2007), http://egov.oregon.gov/dhs/phlgenetics /docs/ acgpr _ 030507.pdf[hereinafter oregon's advisory committee). the oregon statute states that coded or anonymous research thought to be exempt must be officially submitted to the irb for exemption and the irb may exempt this research from review. or. rev. stat. § 192.547(2) (west 2003). 123. oregon's advisory committee, supra note 122, at 7. 124. see id. at 8. 240 indiana health law review [vol. 5:217 sent even if research is anonymous. alaska's strict laws are a response to sev­ eral historical breaches of research ethics involving the indigenous population, such as the human genome diversity project and the genographic project. 125 these approaches are diverse, but they all attempt to provide patients and tissue donors with greater control over what happens to their tissues. the re­ quirements for informed consent extend to all researchers, not just those who are federally regulated, which closes a significant loophole. patients and do­ nors can therefore feel that they are more in control of whether and how their biological specimens are used. in addition, they have corresponding control over the privacy of their information, at least to the extent that they can refuse to donate to research. exactly how these additional protections would impact research effi­ ciency is, in the end, an empirical question. still, it is worth speculating, par­ ticularly when states are keen to attract life sciences companies. with these additional protections, research efficiency is partially subordinated to respect for autonomy and protection of privacy. depending on the state's response, researchers would fmd additional requirements to obtain informed consent in cases in which it was previously unnecessary. delaware's law, for instance, would impose many of the same hurdles that already exist, such as finding peo­ ple to obtain consent, ensuring that people read their mail to find out what's happening, and the loss of samples to people who become annoyed by being re­ contacted, but who otherwise do not object. in addition to these barriers, ore­ gon faces the additional hurdle of providing notice to all health care providers of the legislative changes so that health care providers and clinics can adapt to these new laws. additionally, monitoring patient opt-out requests is challeng­ ing for laboratories (particularly when samples are sent from one lab to an­ other), and the costs of notifying consumers is significant (but it is not quantified in the committee's 2007 report).126 in alaska, the barriers to con­ duct genetic research may be insurmountably high. consent is required even for anonymous research, and ownership rights remain with individuals even, it would seem, after commercial products have been developed. 127 it is also not clear how these additional protections would affect public support of the research agenda ofbiobanks. anecdotal data from oregon sug­ gests that consumers are dissatisfied that they are required to opt-out of certain kinds of genetic research, rather than affirmatively choosing to participate. 128 this data reveals that the public does not understand that its health information and biological samples are already used without consent in some circumstances 125. brett shelton, consent and consultation in genetic research on american indians and alaska natives, indigenous peoples council on biocolonialism, http://www.ipcb.org /pulications!briefing_papers/files/consent.html (last visited mar. 17, 2008); declaration of in­ digenous peoples of the western hemisphere regarding the human genome diversity project, http:/!www.tebtebba.org/tebtebba _files/susdevlbdv/iphgdp.html (last visited mar. 18, 2008). 126. see oregon's advisory commntee, supra note 122. 127. alaska stat. § 18.13.010 (2006). 128. oregon's advisory committee, supra note 122, at 7. 2008] a proposal for comprehensive biobank research laws 241 under federal law. although oregon citizens receive additional protections un­ der their genetic privacy and research laws, they may become more suspicious and less supportive of research in general. therefore, on the one hand, it is en­ tirely possible that public support of biobank research will decrease, because people have a better understanding of what little protections they actually have. on the other hand, it is possible that over time, oregon citizens will support genetic research because they trust the researchers and feel that they have some control over the research projects that are undertaken. the range of patient protections in this area provides insight on several factors regarding the balance of efficiency and public involvement from which states may benefit. failing to inform the public and earn the public's trust has resulted in either restrictively reactive laws or laws with which the public may not fully understand or agree. both responses, either fully protecting individual rights or only recognizing increased individual protections for certain types of research, impede efficiency when the laws are not balanced with a mechanism to streamline the research process for donors who do provide consent. 2. state laws that promote research efficiency some states resolve the federal regulation's ambiguity in favor of promot­ ing research efficiency, but in a way that provides limited usefulness for the development of translational medicine. these states create extensive excep­ tions that allow a researcher or physician129 to obtain, store, and use biological specimens and medical information under federal regulatory exemptions, such as irb waivers, or under a "medical or scientific research" exemption.130 when collecting a sample under these laws, the researcher does not need to ob­ tain actual informed consent explaining that the sample will be used for re­ search or stored in a repository. these laws also do not restrict the research to ohrp' s enumerated uses but rather allow researchers to store the genetic sam­ ple and information in a biobank for future unspecified uses or to use them in a specific research project. 131 for example, this type of law would allow a re129. for the sake ofbrevity, the authors refer to the person obtaining, using, and retaining the genetic samples as the "researcher" or "physician." many statutes use the general term "per­ son," which, in addition to a physician or researcher, could include nurses, lab technicians, re­ search institutions, and hospitals. the authors also use the term "patient" or "participant" to indicate the person donating the sample for genetic research. many statutes provide only a gen­ eral definition of "individual" when referring to the person donating the sample. individual state statutes should be consulted to determine the precise definition of each term in a particular state. 130. n.m. stat. ann.§ 24-21-3 (west2008); nev. rev.stat.ann.629.151 (west2000); nev. rev. stat. ann. 629.181 (west 2008). 131. this appears to be in conflict with federal guidance suggesting that merely collecting a human biological sample constitutes a single research activity, and any subsequent use of that tissue constitutes an additional research activity requiring separate consent. see barnes & hef­ fernan, supra note 18, at 446. 242 indiana health law review [vol. 5:217 searcher to collect a biological specimen for future biobank use without obtain­ ing the patient's informed consent. laws that enumerate informed consent exceptions are the most permissive and promote the use of genetic materials in research by exempting medical or scientific researchers from obtaining informed consent to store samples in a repository or to use them for genetic research. several states, such as new mexico and nevada, allow physicians and researchers to obtain, use, and retain a patient's genetic sample as long as the genetic sample is used for"medical or scientific research"132 or the sample goes to a statewide repository. some states that use this model, such as new mexico, place conditions on the confidential­ ity protocol to ensure genetic samples are coded or anonymous. new mexico also specifies that this exemption process must comply with relevant federal regulations. 133 through the statutory exemptions or irb waivers, these state laws resolve federal law ambiguities in favor of research efficiency, increasing the volume of samples collected for research or storage by eliminating the obstacles and costs associated with obtaining consent for each use. however, despite its short-term research efficiency, this model has two substantial drawbacks for states hoping to support translational medicine. first, data from samples that have been col­ lected without informed consent cannot be used to support fda applications, with the possible exception of in vitro diagnostic devices under certain circum­ stances.134 second, this model poses a high risk of public backlash because it promotes the importance of research advancements without obtaining the per­ mission of individuals whose materials may be used, and without engaging the public to gain its informed support. n. indiana's legislative options part n describes current indiana statutes involving genetic information. indiana has very few laws related to this subject, and could benefit from further legislation regarding biological specimens and genetic information in biobank­ ing research. however, arguably, none of the approaches discussed with pre­ vious state efforts strikes the right balance among the ethical values at stake. 132. the definition of"medica1 or scientific research" may differ from state to state. new mexico states that medical or scientific research and education include the "retention of gene products, genetic information or genetic analysis if the identity of the person or person's family members is not disclosed" but does not explicitly preclude partnerships with private entities. n.m. stat. ann.§ 24-21-3 (west 2008). 133. id. 134. in its recent guidance, the fda stated that it "does not intend to object to the use, without informed consent, ofleftover human specimens ... in investigations that meet the crite­ ria for exemption from the investigational device exemptions ("ide") regulation at 21 c.f .r. 812.2(c)(3), as long as subject privacy is protected by using only specimens that are not indi­ vidually identifiable." u.s. fda, guidance on informed consent for in vitro diagnostic device stijdies using leftover human specimens 1hat are not individually identifiable (2006), available at http://www.fda.gov/cdrhloivd/guidance/1588.pdf. 2008] a proposal for comprehensive biobank research laws 243 the respect for donor control and privacy protection that is gained in states like delaware, oregon, and alaska come at a very high cost in terms of research efficiency. attempts to facilitate research, represented by states like new mex­ ico, may risk a public backlash, and may be unable to support the most valuable kinds of translational research. 135 the proposal here, therefore, recommends statutory provisions that demonstrate respect for the persons who may donate tissue to biobanks while also creating an environment that supports high quality translational research. a. existing indiana law related to genetic information 1. repositories or genetic information databases neither the indiana legislature nor the indiana courts have addressed indi­ vidual rights relating to dna or genetic material in the research context. indi­ ana does have a dna database for criminal identification and statistical purposes, 136 but indiana courts have only applied this law in the criminal con­ text.137 2. indiana statutory definitions of genetic testing; insurance coverage indiana law defines genetic tests relating to insurance coverage and speci­ fies that the definition only applies for the purposes of regulating certain cate­ gories of insurance coverage. 138 the law defines genetic screening tests as tests to identify an individual's chromosomal abnormalities or carrier status to indi­ cate susceptibility to a particular disease. 139 indiana law also prevents health care services organizations from basing the provision of health care services on these genetic test results. 140 indiana does not extend this definition or offer a similar definition for genetic testing for research purposes or genetic testing on individual samples removed from an individual and used within a biobank or repository setting. 135. samples that are collected without informed consent will not have the rich annotation many researchers find indispensible to quality research as data from those samples cannot be used to support fda applications, which is a key step in developing medical products. 136. see ind. code§ 10-13-6-13 (2007). 13 7. the indiana case applies only within the criminal context for the purpose of perpetra­ tor identification. indiana case law has clarified the legal status of a criminal defendant's dna. the indiana supreme court held that once a defendant's dna is used to create a profile for the databank, it becomes the property of the databank and the defendant has no possessory or own­ ership interest in the dna profile. smith v. state, 744 n.e.2d 437,439 (ind. 2001). 138. ind. code§ 27-8-26-1 (2008). 139. /d. 140. ld.; ind. code§ 27-8-26-5 (2008). 244 indiana health law review [vol. 5:217 indiana law provides that insurance companies may obtain the results of an individual's health records or medical information, which may include ge­ netic screening or tests, with a separate written consent.141 if the insurance company inadvertently receives genetic information, the insurance company is not liable for failing to obtain the informed consent form. 142 this provision does not apply to life insurance policies. 143 indiana also has specific provisions which prevent some adverse actions by insurance companies as a result of genetic testing. 144 for instance, an in­ surer may not require genetic screening or testing, or consider any information obtained from genetic screening or testing in a manner adverse to the applicant or the applicant's family that would limit benefits or establish premiums for health insurance coverage.145 additionally, in developing and asking questions regarding the medical history of an applicant for health care services coverage, an insurer may not ask for the results of genetic tests or ask questions designed to ascertain those results.146 these provisions do not apply to genetic testing on an individual's sample for research purposes, but rather are applicable to genetic screening tests for health care purposes. unlike other state laws which explicitly prevent insur­ ance companies or other parties from discriminating based on genetic informa­ tion obtained during the research process.147 indiana law is not clear on this issue. b. approaches to addressing indiana's lack of legislation 1. status quo there are both positive implications as well as potential drawbacks from relying only on federal regulations from the perspective oflndiana's various life sciences initiatives. there are at least short-term benefits for industry and re­ searchers because there are no additional or contradictory state laws that could impede interstate or international collaborations. patience may be a virtue be­ cause congress or dhhs and fda may take action to create a harmonized ap­ proach. finally, as noted earlier, state courts so far have tended to support institutions in cases involving conflicts about tissue control and ownership. however, it is also possible that indiana's reliance on the status quo could have a negative impact on research. institutions may be hesitant to engage in genetic 141. ind. code§ 16-39-5-2 (2008). 142. /d. 143. id. 144. ind. code§§ 27-8-26-6 to 27-8-26-7 (2008). 145. /d. 146. ind. code§§ 27-8-26-5 to 27-8-26-9 (2008). 147. n.m. stat. ann.§ 24-21-4 (west 2008). 2008] a proposal for comprehensive biobank research laws 245 research and biobanking projects due to fears oflitigation related to compliance uncertainty. the public may also be reticent to donate specimens to research if it takes place outside of standardized regulations, effectively hindering the long-term sustainability of this kind of research. 2. a comprehensive approach for indiana in addition to the state models that already exist, there may be additional legal approaches that indiana could take that both respect and adequately pro­ tect patients while promoting research efficiency. what follows is a recom­ mendation for a comprehensive set of statutory provisions that address the unique concerns relating to biobanking and genetic research. 148 unlike some current state models, these provisions include: a comprehensive legal frame­ work for biobanking and genetic research that addresses informed consent, the protection of genetic privacy from unauthorized disclosures, a model for liabil­ ity, a plan for implementation by the state department of health, and a mecha­ nism for ongoing evaluation and revision. a. tiered or blanket informed consent for all tissue use the legislative approach recommended herein recognizes the human sub­ jects framework of consent and privacy, yet takes measures to streamline the consent process without compromising individual privacy protections. this approach strives to embody the idea that research efficiency and respect for in­ dividual control are not mutually exclusive. this approach would require obtaining a modified form of actual consent from all donors, either by means of a tiered consent (which allows the donor to choose permissible research uses of a specimen from among several options) or blanket consent (a one-time consent to any future research uses). it would abol­ ish the use of anonymous samples in research without consent, as well as the use of coded samples with the use ofirb exemptions or hip aa waivers. al­ though at first glance this appears to increase hurdles for researchers, it should be an acceptable burden for two reasons. first, researchers recognize that the most promising research can be undertaken only in the context of richly anno­ tated samples, and their use usually requires informed consent. second, if the goal of changing indiana's laws is to promote the translation of research into clinical products, then the tissues that are banked must be able to support fda applications, which in tum require that explicit informed consent be obtained. in recognizing the unique concerns of biobanking and genetic research, the statute could relax the traditional informed consent requirements and strike a compromise by creating an express authorization that tiered or blanket me148. there may well be other approaches that would work, or permutations of this model that would better satisfy the diverse interests in the life sciences. 246 indiana health law review [vol. 5:217 thods of consent are permissible if they contain sufficient specificity about the research in the informed consent form. the statute could recognize and permit a singular consent and hip aa authorization for the collection, storage, and use based on whether the tiered or blanket form is used. although the privacy rule stipulates that a research institution shall provide an individual with a "specific and meaningful"149 description of the research prior to authorizing use of the individual's phi, some have argued that this provision does not prohibit or in­ validate an individual's authorization to use his or her phi for future research in general.150 allowing each individual the right to decide whether or not to participate in biobank research respects autonomy and individual dignity if the informed consent form discloses in good faith as much information as is practicable. fu­ ture legislation with respect to benefits should note that no personal benefit from contribution is expected to arise, and the institution will not provide the individual with any information relating to the results of any genetic testing or research. with respect to risks to the individual, the consent should include the immediate physical dangers of extracting the specimen, any threats to informa­ tion confidentiality, and insurability and employability based on genetic infor­ mation. in addition, disclosures should include the types of genetic research that may be performed, partnerships with private entities, and plans to develop commercial products. despite heightened respect for the donor's initial decision to donate or de­ cline participation, the institution would gain immense control once the indi­ vidual donates the specimen and the institution codes it. this solution could also allow for individual withdrawal of the coded specimen and information, but would expressly deny donors a right to transfer, direct, or manage the spe­ cimen once donated. the loss of control once the individual donates the spe­ cimen would also mean that this solution would not explicitly recognize any individual property right in genetic information or a genetic specimen. this solution would also prohibit re-identifying the specimens and connecting any genetic information to the individual's identity. 149. 45 c.f.r. § l64.508(c)(l)(ii) (2008). 150. david wendler notes that the privacy rule currently allows individuals to make a single general authorization of their phi "to be used in future research to find better ways to treat and cure disease." the dhhs has suggested that the privacy rule as written contains two shortcomings: (1) individuals authorizing use of their phi lack the necessary information to make an informed decision; and (2) the privacy rule does not require irb or privacy board review of research uses and disclosures made with individual authorization. wendler proposes that one time general consent and authorization may be permissible if an irb reviews and ap­ proves future research that would be consistent with the individual's original authorization. david wendler, one-time general consent for research on biological samples, 166 archives of internal med. 1449, 1450 (2006). 2008] a proposal for comprehensive biobank research laws 247 b. disclosures andre-identification specimens should remain coded and re-identification of the specimens should be prohibited. indiana law should compensate for the current lack of federal protections against unauthorized disclosures of genetic information to employers and insurance companies. this policy would minimize public fear and concern about potential discrimination that might otherwise hinder willing­ ness to donate. this policy could also prevent conditioning an application for employment or insurance coverage on obtaining a genetic test, on particular results of a genetic test, or any other actual, perceived, or assumed genetic char­ acteristics. c. liability the legislature should adopt a model of civil liability that recognizes the importance of compliance with relevant consent or privacy provisions, and also serves as a possible deterrent from unauthorized disclosures connecting an in­ dividual to genetic information. criminal liability is not advisable, as it may unnecessarily deter research and development interests and investments. this solution would recognize that a limited class of individuals has standing to bring a claim, recognizing only the individual, the individual's im­ mediate family members, and the attorney general. despite the narrow class of individuals with standing, the law would recognize the broad class of potential breaching parties and extend a duty and liability to the researchers, physicians, institutions, and research partners involved in the breach. to prevent hin­ drances to research, the law would not rely on a strict liability model but rather outline a series of violations based on mental intent. violations could be based on a tiered level, ranging from negligent violations to willful violations. one remedy may include temporary injunctive relief at the minimum, irrespective of the level of intent. additional remedies could be awarded based on a showing of a particular level of intent, and the law would accordingly specify a mini­ mum amount of money damages based on the nature of the breaching party's intent. d. implementation of legislative changes a practical way of implementing these legislative changes and creating uniformity among research institutions would be to charge the indiana state department of health with the responsibility of educating indiana citizens (in­ cluding health care providers), assisting in the integration of genomic medicine into clinical care, and providing ongoing assessment oflndiana's genetic re­ search laws. 248 indiana health law review [vol. 5:217 (i) outreach and education increasing the public's genomic literacy should occur in several environ­ ments by including a legislative provision requiring the department of health to introduce educational components in schools, inform the general public via media outlets, and further educate the professional community. the depart­ ment of health could partner with the department of education to integrate information about genetics and health care into the public school health curricu­ lum. the department of health's public education effort should target varied media outlets such as public service advertising and informational websites, in addition to brochures and pamphlets disseminated by health care providers. recently revised umbilical cord blood collection laws in california provide a useful model of how to inform the public of important research endeavors while notifying them of the legal requirements related to donation. the california statute lists various methods to increase public awareness through the use of brochures, television, print media, radio, internet websites, outdoor advertising, and other media. similar to cord blood banking, the public should be fully in­ formed of the benefits of genetic research which could be accomplished in a comparable manner. 151 the department of health should also devise a system to provide ongoing education and training to health care professionals to in­ crease awareness of available technologies and promote integration of transla­ tional medicine into health care delivery. (ii) integration of genomics into personal health care research using banked materials should yield improvements in transla­ tional medicine, such as genetic screening tests and targeted therapies. indiana law should describe the importance of returning broad public health benefits based on ongoing field advancements by increasing the use of genetic screen­ ing, counseling, and targeted therapies to be coordinated by the department of health. consideration may also be given to how genetic screening tests and per­ sonalized medicine will be provided as a viable health care option, which in­ cludes financing and reimbursement issues that impact genetic services delivery. this section could specify how public and private insurance will clas­ sify the use of genetic screening and testing services and give the department of health the task of compiling additional findings relating to data on reim­ bursement rates, fmancing, delivery, and any potential changes needed to en­ courage public utilization of genetic services. 151. see cal. health & safety§ 123370 (west 2008). 2008] a proposal for comprehensne biobank research laws 249 (iii) evaluation and ongoing advisement the indiana state legislature and department ofhealth should develop a system of review to assess the progress of the goals enumerated by the depart­ ment of health. the department could appoint a committee to monitor and address possible barriers to implementation of collection initiatives, new re­ search discoveries, and empirical data to show improvements in diagnosis and treatment of patients using the state's genetic services. the department of health should create a mechanism such as an advisory group to remain knowledgeable and compliant with relevant legal changes at the federal level and in case law. although the recently proposed genomic and personalized medicine act of2006152 has not been enacted, the congressional pattern of passing similar legislation such as the preemie act of2006153 sug­ gests that congress may enact federal laws to promote the development ofbio­ banking initiatives. this type of law may provide financial support through federal grants or clarify ambiguities in current regulations and guidance by, for example, delineating substantive requirements for an informed consent form or defining ownership. similarly, if the genetic information nondiscrimination act (or similar legislation) passes on the federal level, state legislation and prac­ tices should reflect prohibitions against discrimination on the basis of genetic information. additionally, the advisory group should create a working plan to educate both the public and professional communities on how to comply with these legal changes. this advisory group should also monitor updates in case law across the country because even nonbinding precedent in this subject area has strongly influenced subsequent dispute resolutions. the department ofhealth should also assign a committee to monitor cur­ rent ethical, legal, and social issues related to biobank research, including unre­ solved or ambiguous issues related to informed consent, privacy and confidentiality, commercialization, and how to determine the benefits that ac­ crue to the public through better health care and/or local economic develop­ ment. 152. the genomic and personalized medicine act proposes standardizing portions of in­ formed consent forms "including those that allow multiple uses of data for research purposes" which suggests a move toward permitting tiered or blanket consent in the biobanking context and/or data sharing arrangements. this bill would also make recommendations to definitively address ownership of the samples and information. enactment of s. 3822, or a similar law, could standardize legal approaches and render moot portions of the current ethical debate based on legal ambiguities. genomics and personalized medicine act, s. 3822, 1 09th cong. (2006), available at http://www.govtrack.us/data/us/bills.text/l 09/s/s3822.pdf. 153. preemie act, s. 707 1 09th cong. (2006), available at http://www.govtrack.us/data /us/bills.text/1 09/s/s707 .pdf. 250 indiana health law review [vol. 5:217 v. conclusion biobanking's promises of advances in translational research are contin­ gent upon collection of the public's biological specimens, which requires main­ taining the trust of both the public and potential investors to support translational research. previous solutions have erroneously submitted to the proposition that research efficiency and respect for donors are mutually exclu­ sive. this has resulted in some instances of donor dissatisfaction and legal bat­ tles, a losing solution for both donors and institutions. a comprehensive legislative solution can work to minimize legal uncertainty related to the collec­ tion, use, storage, and disclosure of individuals' sensitive and invaluable ge­ netic samples and information. educating and engaging both the public and institutions through such a solution will streamline thebiobanking process, en­ couraging altruistic donation while producing beneficial research innovations. microsoft word 1-masthead vol. viii.doc aals torts and compensation systems section william l. prosser award bestowed upon guido calabresi catherine m. sharkey∗ the william l. prosser award recognizes “outstanding contributions of law teachers in scholarship, teaching and service in . . . torts and compensation systems.” when wex malone bestowed the first prosser award upon leon green in 1974, he said it was “designed to recognize a lifetime of truly outstanding contribution to the world of torts.” subsequently, fleming james, wex malone, page keeton, john wade, and willard pedrick received the prosser award. revived in 2008, recent recipients include robert rabin (2008), dan dobbs (2009), and oscar gray (2010). it is my great honor and pleasure to present the 2011 prosser award to guido calabresi. judge calabresi was appointed to the u.s. court of appeals for the second circuit in 1994. before that, he was dean and sterling professor at yale law school, where he began teaching in 1959. he is now sterling professor emeritus and professorial lecturer in law at yale. guido calabresi was a pioneer in the economic analysis of law. his path-breaking 1970 book, the cost of accidents,1 was followed by three more books and over one hundred law review articles, including the venerated “property rules, liability rules and inalienability: one view of the cathedral.”2 he is also a revered teacher and mentor. indeed, at the ripe age of twenty-four when i entered yale law school, i thought it a form of “cosmic injustice” that i was not assigned calabresi for torts, as his work was largely responsible for my budding interest in law and economics. higher forces aligned in time, as i was given the honor to serve as one of his law clerks from 1997-1998. even during that term alone, judge calabresi continued to transform the torts landscape, with cases such as zuchowicz v. united states3 and liriano v. hobart corp.,4 now having entered the canon. judge calabresi has been awarded some forty honorary degrees from universities in the united states and abroad. but the bestowal of the prosser award is especially meaningful, as his remarks that follow make abundantly clear. ∗ professor of law, new york university school of law. chair, aals torts and compensation systems section, 2010-11. law clerk to the hon. guido calabresi, 1997-98. 1. guido calabresi, the cost of accidents: a legal and economic analysis (1970). 2. guido calabresi & a. douglas melamed, property rules, liability rules and inalienability: one view of the cathedral, 85 harv. l. rev. 1089 (1972). 3. zuchowicz v. united states, 140 f.3d 381 (2d cir. 1998). 4. liriano v. hobart corp., 132 f.3d 124 (2d cir. 1998). prenatal testing gone awry: the birth of a conflict of ethics and liability elizabeth a. ackmann* introduction in today's world of constantly evolving technology, a pregnant woman can know many details about the fetus inside of her before it is born. although most of the prenatal testing that is commonly conducted in the united states is not brand-new technology, expansions in tort law for both wrongful death and medical malpractice have brought a new focus on prenatal testing and to the physicians and health care workers who are administering and interpreting the tests. the recent prevalence of medical malpractice claims has resulted in the claim of medical malpractice being used in different cases. this topic is a novel issue because there is a potential for recovery for fetal torts under the theory of malpractice where the same suit would be dismissed under the guise of a wrongful death claim. even if medical malpractice claims are curtailed by legislation in the coming years, the "viability'' or "quickening"1 standards used by many states to block wrongful death claims of a fetus might have to be reevaluated as medical technology effectively moves forward the date when a fetus could be considered viable. further, this topic is noteworthy from the standpoint of the actual process of genetic screening. the expansion of medical malpractice liability could extend to the medical technologists who perform the prenatal tests and to the genetic counselors who play important roles in relaying information and options to women carrying fetuses with indi­ cated problems. finally, the issue of medical malpractice with regard to faulty prenatal testing is complicated by the fact that the women choose to terminate their pregnancies. the choice to terminate might affect a court or jury's deter­ mination of potential liability on the physician or genetic counselors. the issue of a woman's decision to terminate her pregnancy based on an incorrect prenatal test interpretation was brought before the georgia court of appeals in december, 2002. in breyne v. potter, the georgia court of appeals recognized a cause of action for a forty-year-old woman who aborted her fetus based on her physician's recommendation.2 the woman's obstetri­ cian told her on two separate occasions that the results of the test indicated that • j.d. candidate, 2005, indiana university school oflawindianapolis; b.a., 2000, purdue university, west lafayette, indiana. the author wishes to thank mary hoeller and shelley fraser for their invaluable assistance and advice. i. see parts ii.b and ii.c, ilifra, for a discussion on the definitions of" quickening" and ''viability." 2. breyne v. potter, 574 s.e.2d 916 (ga. ct. app. 2002). 200 indiana health law review [vol. 2:199 the fetus had down's syndrome, and he recommended that if she was con­ sidering an abortion that she act quickly because of the advanced gestational age of the fetus.3 the woman chose to have an abortion.4 however, the obste­ trician had misread the test results on two separate documents provided to him by the lab, and in fact, the fetus had trisomy-x.s trisomy-x does not generally lead to gross physical abnormalities although the exact effects on children vary from case to case.6 the obstetrician informed the woman of his mistake after the abortion but indicated to her that trisomy-x was an aftliction with similar symptoms and trademark character traits to down's syndrome.7 the reality is some people born with trisomy-x have no phenotypical signs of the abnor­ mality and lead very normal lives. 8 after the trial court ruled in favor of the obstetrician, the woman pre­ vailed on her appeal to the appellate court in georgia.9 however, the court was clear in pointing out the judgment for the woman was based on the fact that her claim was a medical malpractice claim and not a wrongful death claim.10 georgia's rule oflaw stipulates that no cause of action exists for the wrongful death of an unborn child who was not "quick" or ''viable" at the time the fetus died. 11 this note will discuss the effect a woman's choice to abort her fetus could have on the physician who incorrectly interpreted a prenatal test and advised the woman to consider termination of the pregnancy. although many states do not recognize a wrongful death cause of action for a fetus, recovery is still possible in the form of a medical malpractice claim. part i of this note discusses the basics of prenatal testing, addresses the background of a fetus within the law, and notes the evolution of the tort of wrongful birth. part it discusses wrongful death, policy issues behind denying a wrongful death claim, an explanation of the quickening and viability standards, suggesting that the abolition of those benchmarks would lead to more acceptance of fetal wrongful death. part ill outlines medical malpractice claims and the greater possibility of recovery under this tort. part n addresses how a woman's choice to terminate a pregnancy affects the outcome for recovery and creates a conflict with the recognized right of a woman to be able to make that choice. part v determines that while it is possible prenatal diagnostic laboratories and genetic counselors could be held vicariously liable for their involvement, their lack of education and training in comparison to the physician will likely mitigate their case. 3. id at918. 4. id. s. id. 6. id. 7. id. 8. breyne, 574 s.e.2d at 918. 9./d 10. id. 11. id. at 919. 2005] prenatal testing gone awry i. successful conception ••. what happens when a good thing goes wrong? 201 a. prenatal testing: success and acceptability growing into a problem prenatal testing has not varied much in technique since the advent of the use of anlniocentesis in 1966,12 and it is still widely accepted and applied. the appreciable difference from nearly forty years ago is the result of the near completion of the human genome project. this project has resulted in the identification and mapping of more genes, which leads to the possibility of detection of more genetic abnormalities from the routine prenatal tests. gener­ ally, the specimens drawn from pregnant women are sent to a specialized lab which only· analyzes specimens related to prenatal testing. in one prenatal diagnostic laboratory in indiana, the dna is mapped by individual techni­ cians, and potentially abnormal tests are reanalyzed by at least four additional technicians. 13 the most common prenatal genetic screening tests done today in the united states are the maternal triple screen, amniocentesis, and chorio­ nic villi sampling.14 the maternal triple screen test is performed in most, if not all, preg­ nancies. a blood sample is obtained from the woman between the sixteenth and eighteenth week of pregnancy to test for afflictions like spina bifida and chromosomal abnormalities like down's syndrome.15 a component of the maternal triple screen is the alpha-fetoprotein test, which is commonly referred to singularly (the afp test), although it is considered part of the triple screen.16 the risk associated with the afp/matemal triple screen is far less than an amniocentesis or chorionic villi sampling because it is obtained by a blood sample from the woman rather than obtaining a sample of cells from the woman's uterus via needle in the abdomen.17 however, afp can also be done with amniotic supernatant fluid. 18 amniocentesis is a procedure in which cells are harvested from the amniotic fluid surrounding the fetus. 19 the fluid is usually obtained by 12. michaelj. malinowski. coming into being: law, ethics, and the practice ofprenatal genetic screening, 45 hastings l.j. 1435. 1445 {1994). 13. interview with angela m. reese, clsp(cg) [clinical lab specialist in cytogenetics], indiana university school ofmedicine, indianapolis, ind. (aug. l, 2003). 14. david stoller, prenatal genetic screening: the enigma ofselectiveabortion, 12 j.l. & health 121, 123 (1997). 15. jean h. priest & kathleen w. rao, prenatal chromosome diagnosis, in the agt cytogenetics laboratory manual200 (margaret j. barch. et al. eds., lippincott-raven, 3rd ed. 1997). 16. priest & rao, supra note 15, at 200. 17. id. 18. supernatant amniotic fluid is analogous to the plasma component ofblood. it is the amniotic fluid that has had the cells extracted from it already. id. 19. stoller, supra note 14, at 123. 202 indiana health law review [vol. 2:199 inserting a large needle into the woman's abdomen. the drawbacks include: the test is usually not performed before the fifteenth or sixteenth week of preg­ nancy, the results take a couple of weeks to obtain due to the need to harvest the cells, and there is a chance of miscarriage associated with amniocentesis.20 however, the test may be performed as early as the eleventh to the fourteenth week of pregnancy, depending on a patient's needs.21 because of the potential risk of miscarriage, amniocentesis is traditionally performed on older women who have a higher risk of bearing children with chromosomal abnonnalities such as down's syndrome.22 chorionic villi sampling (cvs) takes cells from the chorionic villi, which are "hair-like projections that surround the embryo in the early stages ofpregnancy."23 a physician will use ultrasound to guide a catheter through the cervix to obtain the chorionic villi. this test is beneficial because it must be performed before the tenth week, and no incubation time is needed to har­ vestthe cells; however, a higher risk of miscarriage exists with this type of test compared to an amniocentesis due to the more invasive nature of the procedure. 24 the previously mentioned human genome project, which began in 1989, stands to greatly expand the possibilities of prenatal genetic testing. 25 "specifically, with each success in identifying a genetic abnormality asso­ ciated with the onset of a specific health impairment comes the potential to test fetuses ·for the presence of that genetic abnormality. "26 compared to the early years of prenatal testing, genetic screening today can detect a wider array of abnormalities than the basic chromosomal abnormalities that the tests could identify in the beginning years of prenatal testing. now, as scientists uncover more details about other characteristics of humans already utilized from con­ ventional prenatal testing, parents are able to know far more about their child's future than they have in the past. the completion of the human genetic "road­ map" potentially could allow parents the opportunity to abort their fetuses for less serious abnormalities and could present problems for genetic screening 20. !d. 21. priest & rao, supra note 15, at 199-200. 22. simmons v. w. covina med. clinic, 212 cal. app. 3d 696, 699-700 (cal. ct. app. 1989). 23. stoller, supra note 14, at 123. 24. !d. 25. the human genome project is a government-funded, $300 billion project with the goals of assembling a complete map of the human genetic framework and identifying the base pairs of nucleotides-comprised of the building blocks of adenine, thymine, cytonine and guanino--for each gene. the basic genetic map was completed in 2002, identifying 30,000 genes in the human genome. michael j. malinowski, choosing the genetic makeup of our children: our eugenics pastpresent, and future?, 36 conn. l. rev. 125, 172 (2003). 26. malinowski, supra note 12, at 1445. 2005] prenatal testing gone awry 203 laboratories which could be forced to limit the genetic abnormalities they will analyze,27 b. the "birth" of a fetus within the context of the law at common law, there was no possibility for a wrongful death recovery for a fetus.28 dietrich v. northampton is the landmark case that first recog­ nized the tort of wrongful death for a fetus which died as a result of its mother falling on a sidewalk.29 justice holmes reasoned the fetus is still considered to be a part of its mother, and no separate duty existed with respect to the fetus, which essentially meant that the fetus' chance for recovery was "piggybacked" on to its mother's possibility of recovery. 30 bon brest v. kotz was the first case to allow recovery for a fetal injury if the fetus had attained viability, noting that "apart from viability, a non-viable foetus [sic] is not a part of its mother.'m although the cause of action in bonbrestwas medical malpractice, it was the first step in rapid change towards allowing a basis for recovery in wrongful death. 32 the bonbrest court based its ruling on the premise "[a] child en ventre sa mere3 is not only regarded as human being, but as such from the moment of conception-which it is in fact.''34 the bonbrest decision notes the depar­ ture from the common law concepts that the woman and child were one unit and that a separate duty of care was not owed to the child. 35 the bonbrest rule is that a child, ifbom alive and viable, should be allowed to maintain an action in the courts for injuries wrongfully committed upon its person while in the womb of its mother.36 following the bonbrest decision, the tort of fetal injury expanded to include claims involving direct fetal injury and/or subsequent mi~carriages associated with auto accidents or similar traumatic injury to the woman.37 27. the future societal problems range anywhere from eugenics, the practice of selectively terminating pregnancies based on the presence of more phenotypical genes, to the possibility of discrimination down the road stemming from people who are known to carry certain genes. see, e.g., stoller, supra note 14, at 123, and anita silvers & michael ashley stein, human rights and genetic discrimination: protecting genomics' promise for public health, 31 j.l. med. &ennes 377 (2003). 28. dietrich v. northampton, 138 mass. 14,17 (1884). 29. id. at 14. 30. 66 fed. credit union v. tucker, 853 so.2d 104, 107 (miss. 2003). 31. bonbrest v. kotz, 65 f. supp. 138, 140 (d.c. 1946). 32. id. at 140. 33. en ventre sa mare means ''in the mother's womb." black's law dictionary 226 (1st pocket ed.l996). 34. bonbrest, 65 f. supp. at 140. 35. ld. at 139. 36. ld. at 142. 37. see, e.g., 66 fed. credit union v. tucker, 853 so.2d 104 (miss. 2003); toth v. goree, 237 n.w.2d 297 (mich. ct. app. 1976). 204 indiana health law review [vol. 2:199 c. wrongful birth: the scourge of public policy another prominent fetal tort is wrongful birth, in which parents sue based on the theory they would have aborted the child had they known the child would be born with genetic abnormalities that would seriously affect his/ her quality of life. a kentucky court explained that in the state ofkentucky, the tort of wrongful birth is not a new claim but rather "a traditional medical negligence claim requiring the elements of duty, breach, causation, and injury to be proven for the plaintiffs to prevail.''38 wrongful birth claims are merely medical malpractice claims, and some states hesitate to categorize them in a separate area of tort law, given most states have established specific statutory and/or case law-based procedural guidelines for medical malpractice claims. in bader v. johnson, the indiana supreme court noted it "[saw] no reason for compounding or complicating [the] medical malpractice jurisprudence by according this particular form of professional negligence action some special status apart from presently recog­ nized medical malpractice or by giving it the new name of 'wrongful birth . ..,39 in contrast, maryland recognizes the tort of wrongful birth because "[e]ven though the physical forces producing [the baby's] birth defects were already in operation at the time of the alleged negligence of the physicians, under the chain of causation alleged by [the parents], the physicians could have prevented the harm to the parents ..... o under this theory, the parents and children are considered equally, and this appears to violate the idea the fetus/ infant is separate from the woman. the notion of the close parental and child relationship is connected to the "zone of danger .. theory of torts, which allows family members to recover for emotional distress suffered by witnessing harm to close family members. there is hesitation to allow recovery for emotional distress in wrongful birth actions based on a reluctance to expand the tort of emotional distress.41 in states that do not recognize wrongful birth, there is more emphasis placed on the life of the child and the fact that allowing damages for a child to be born is contradictory to public policy and morality. 42 the supreme court ofnorth carolina stated recognizing wrongful birth equates a "holding that the existence of a human life can constitute an injury cognizable at law.',..3 abolishing wrongful birth in favor of bringing those claims under tradi­ tional medical negligence is probably not a smart decision in light of the 38. grubbs v. barbourville family health ctr. p.s.c., 120 s.w.3d 682, 684-85 (ky. 2003). 39. baderv.jobnson, 732n.e.2d 1212, 1216(ind.2000)(quotinggrecov. united states, 893 p.2d 345,348 (nev. 1995)). 40. reed v. campagnolo, 630 a.2d 1145, 1146 (md. 1993). 41. see, e.g., siemieniec v. lutheran gen. hosp., 512 n.e.2d 691 (ill. 1987). 42. azzolino v. dingfelder, 337 s.e.2d 528, 534 (n.c. 1985). 43. /d. at 534. 2005] prenatal testing gone awry 205 prominence of prenatal· genetic testing. while the policy argument of valuing the life of the child is compelling, this nation has recognized the fundamental right of a woman to choose to have an abortion. in that sense, if a woman is denied the opportunity to make the choice to terminate a pregnancy due to a genetic abnormality, the birth of that child could be considered "wrongful." the state's interest in protecting the life of a fetus would not have come into fruition if the woman had been given an opportunity to exercise her right to an abortion; as long as abortion is legal, the tort of wrongful birth should exist ll. wrongful death a. the development of a new tort the supreme court of indiana noted "'wrongful birth' seems to have its genesis as a play upon the statutory tort of 'wrongful death. "'44 in other words, wrongful death was the first tort from which the others derived. "the purposes of the wrongful death statute are to prevent the wrongful termination of life and provide the beneficiary with compensation for the loss of com­ panionship and society of the deceased, the pain and suffering of the deceased between injury and death, and punitive damages.',..5 mississippi's standards for determining a cause of action for wrongful death are that "[a] jury must determine whether or not a wrongful death has occurred, who, if anyone, is the tortfeasor, and finally, whether damages, if any, should be awarded. •>46 this reliance on the jury could result in sympathy verdicts, especially in this cause of action where the woman has lost a child, if the jury is comprised of parents. these sympathy verdicts would be granted without any consideration for the elements associated with the cause of action. despite the potential of having a sympathetic jury, especially if you are the defendant health care worker, on its face, the tort of wrongful death seems ethically less controversial than wrongful birth, until it is applied to a fetus. there are problems associated with having a cause of action for fetuses via wrongful death statutes. the main problem is the determination of when to recognize the possibility of a wrongful death suit for a fetus. the first method utilized was the "born alive" rule from the bonbrest decision.47 the harshness of this rule with respect to the inability for recovery for fetal injury or death has led many states to replace the born alive standard with the viability stand­ ard, and only eleven states maintain the 'born alive' rule for fetuses.48 these 44. bader, 732 n.e.2d at 1216. 45. 66fed. credit union v. tucker, 853 so.2d 104,109-10 (miss. 2003). 46. id. at 115. 47. see part i.b, supra, for a discussion of the bonbrest v. katz rule. 48. seechatelainv. kelley, 910 s.w2d215 (ark.1995); bayerv. settle,100cal. rptr. 212 (cal. ct. app. 1972); stokes v. liberty mutual ins. co., 213 so2d 695 (fla. 1968); weitl v. moes, 311 n.w.2d259 (iowa 1981); milton v. carymed. ctr., 538 a2d252 (me. 1988); 206 indiana health law review [vol. 2:199 states' adhesion to the harsh rule is a strict reliance on statutory interpretation: "[ c ]ourts adopting the born-alive rule look at the applicable statute, and if no statutory guidance is given, assume that an unborn child does not fit th~ defini­ tion of 'person' so as to fall within the statute's protection.'>49 twenty-eight states and the district of columbia do not recognize wrongful death as a cause of action for a fetus that is not viable. so b. quickening standard because the determination of a quick and/or viable fetus is so lucid due to the different progressions of each pregnancy and the difficulty in occa­ sionally pinpointing the age of the fetus, it is difficult, as a matter oflaw, to set guidelines for courts to follow. some courts have set basic defmitions to use in their consideration of these types of cases. the georgia court of appeals defined quickening as "some form of fetal movement that the woman can feel, such as the fetus kicking a leg. [q]uickening generally occurs sometime between the tenth week and fourth month of pregnancy.''51 the court clarified its position on the fetal movement by holding the "heartbeat alone is not sufficient movement to constitute quickening. "52 however, twenty years prior to this defmition of quickening, the georgia court of appeals held "[t]he mere fact that appellant had not felt the movement of the fetus does not necessarily mean that the fetus did not move or was not capable of movement at the time grafv. taggert, 204a.2d 140(n.j.1964); inreestateoflogan.l44n.e.2d 644(n.y.1957); hogan v. mcdaniel, 319 s.w.2d221 (tenn. 1958}, wittyv. am. gen. capital distributors, 727 s.w.2d 503 (texas 1987); webb v. snow, 132 p.2d 114 (utah 1942); kalafut v. gruver, 389 s.e.2d 681 (va. 1990). · 49. murphys. klaising, the death of an unborn child: jurisprudential inconsistencies in wrongful death, criminal homicide, and abortion cases, 22 pepp. l. rev. 933,940 (1995). 50. see wade v. united states, 745 f. supp. 1573 (d. hawaii 1990); espadero v. feld, 649f. supp.1480(d. colo.l986); simmonsv.howarduniv.,323f. supp.529(d.c.1971); eich v. town of gulf shores, 300 so.2d 354 (ala. 1974); summerfield v. super. ct., 689 p .2d 712 (ariz. 1985); hatala v. markiewicz, 224 a2d 406 (conn. super. ct. 1966); worgan v. greggo & ferrara, inc., 128 a.2d 557 (del. super. ct. 1956); yolk v. baldazo, 651 p.2d ii (idaho i982); seefv. sutkus, 583 n.e.2d 510 (10. 199i); britt v. sears, 277 n.e.2d 20 (ind. 1971 ); hale v. manion, 368 p .2d 1 (kan. 1962); rice v. rizk. 453 s. w.2d 732 (ky. ct. app. 1970); state, use ofodham v. shennan, 198 a.2d 71 (md. 1964); moue v. greyhound lines, inc., 331 n:e.2d 916 (mass. 1975); o'neill v. morse, 188 n.w.2d 785 (mich. 1971); state v. soto, 378n.w.2d 625 (minn. 1985); strzelczykv. jett, 870 p.2d 730 (mont. 1994); whitev. yup, 458 p.2d617 (nev. 1969); wallacev. wallace,421 a.2d 134 (n.h. 1980); salazarv. st. vincent hosp., 619 p.2d 826 (n.m. ct. app. 1980); didonato v. wortman, 358 s.e.2d 489 (n.c.l987);hopkinsv.mcbane,359n.w.2d862(n.d.l984);werlingv.sandy,476n.e.2d 1053 (ohio 1985); libbee v. permanente clinic, 518 p .2d 636 (or. 1974); coveleski v. bubnis, 634 a.2d 608 (pa. 1993); fowler v. woodward, 138 s.e.2d 42 (s.c. 1964); vaillancourt v. med. ctr. hosp. of vermont, inc., 425 a.2d 92 (vt. 1980); moen v. hanson, 537 p.2d 266 (wash. 1975); kwaterski v. state farmmut. auto. ins. co., 148 n.w.2d 107 (wis. 1967). 51. citron v. ghaffari, 542 s.e.2d 555, 551 (ga. ct. app. 2000). 52. /d. at 555. . , 2005] prenatal testing gone awry 207 of the unborn child's death."53 this broad interpretation of the concept of quickening was almost certainly problematic for courts to handle, and there is little e"vidence that could be admitted or presented on either side as proof of quickening apart from the woman's own testimony. .: c. the viability standard's many downfalls viability of the fetus occurs at a point later in the pregnancy, although, like quickening, it is equally difficult to attach it to a specific gestational'age. in the supreme court's landmark abortion case roe v. wade, the court stated "[ v ]iability is usually placed at about seven months ([twenty-eight] weeks) but may occur earlier, even at [twenty-four] weeks."54 however, less than twenty years later in planned parenthood v. casey, 55 the supreme court estimated viability likely occurs closer to twenty-three or twenty-four weeks' gestation.56 in add.i,tion to relying solely on the gestational age of a fetus, the supreme court i~tified several factors to consider in identifying whether or not a fetus is viable: the gestational age of the fetus, derived from the reported menstrual history·ofthe woman; fetal weight, based on an inexact estimate of the size and condition of the uterus; the woman's general health and nutrition; the quality of the available medical facilities; and other factors. 57 however, the court cautioned against placing complete reliance on these factors largely because.ofthe relatively large number of factors and the fact that many of the statistics associated with the factors vary greatly from person to person, making a fetus' chances of"obtaining meaningful life outside the womb" very difficult to determine. 58 further, the court noted some physicians, even if they have determined a probability of survival for the fetus, will only say a fetus is viable if they have determined a specific chance of survival, and some physicians will not associate viability with any percentage of survival. 59 53. shirleyv. bacon, 267 s.e.2d 809, 811 (ga. ct. app. 1980). 54. roe v. wade, 410 u.s. 113, 160 (1973). the other notion to consider is the fact medical technology has evolved since the roe decision in 1973. when roe was decided, "a twenty-eight week old fetus had about a one in ten chance of surviving," but today, babies born at twenty-eight weeks' gestation have a much greater chance of surviving. klaising, supra note 49, at 941. 55. planned parenthood v. casey, 505 u.s. 833,873 (1992). 56. klaising, supra note 49, at 947 (citing casey, 505 u.s. at 860). 57. colautti v. franklin, 439 u.s. 379, 395 (1979). 58. /d. at 395. 59. for example, a physician might say a fetus is viable if it has a seventy-five percent chance of survival, whereas another physician might call a fetus viable if it only has a fifty percent chance of survival, based on each physician's personal belief. id. 208 indiana health law review [vol. 2:199 d. the abolition of any special standard for fetal wrongful death the supreme court of west virginia abolished the distinction in·case law for nonviable versus viable fetuses in the 1995 decision of farley v. sartin. 61!. the farley case was a wrongful death claim filed against a truck driver and his company following the death of a woman who was approxi­ mately eighteen weeks' pregnant at the time of the crash.61 that court noted adjudicating cases involving nonviable and viable fetuses in the same manner, recognizing that a cause of action exists for all fetuses regardless of viability, saves a trial court from having to undergo the factual analysis of determining whether the fetus is viable, and it allows for families to recover because their loss is not any less traumatic because the fetus is not viable.62 although the standards for detennining whether there has been a wrongful death of a fetus are not very clear, much less even recognized by most states, wrongful death is something that should be reconsidered to apply to all fetuses, and state legislatures should reexamine the issue to avoid forcing a court to make a decision on the issue.63 perhaps the most compelling reason is it allows for recovery when recovery may not be possible under any other application of the law. 64 the supreme court of south dakota noted "someone could fatally injure an unborn child by a nonconsensual, wrongful act and still avoid civil liability because the child was not yet viable . . . . [this] would, ironically, give the tortfeasor the same civil rights as the mother to terminate a pregnancy.'t6s this recognition of wrongful death for a fetus as a possibility of recovery and punishment for the tortfeasor has been distinguished from the woman's right to privacy, noting the "[ e ]xclusion of the unborn from personage under the fourteenth amendment served to advance a woman's constitutional right to privacy, whereas exclusion under a wrongful death statute serves only to 60. farley v. sartin, 466 s.b.2d 522 (w.va. 1995). 61. id at 523. 62. id at 534. 63. in 2003, the nebraska legislature (which is unicameral) passed legislation allowing for a wrongful death cause of action of a fetus regardless of gestational age. neb. rev. stat. § 30-809(1) (2003). however, the statute excludes a physician ftom being held liable under this act if the death occurred as the result of a medical procedure in which "the requisite consent was given." neb. rev. stat.§ 30-809(2)(b) (2003). 64. onmarch25, 2004, the unitedstatessenatepassedh.r.l997, the unborn victims ofviolence act. which would permit a separate cause of action for fetuses in federal offenses. although similar versions of this bill were passed by the house in 1999 and 200 i and failed to receive a senate hearing, the new designation of the legislation as "laci's law," in response to the 2002 death oflaci peterson and her unborn child in california, which brought increased attention to the bill. it has been noted the legislation further weakens the roe v. wade doctrine. however, the key provision in this legislation as it pertains to this issue is medical professionals are specifically excluded ftom liability under this law. h.r. 1997, l 08th cong. (2004). carl hulse, voteinhousesayslt'scrimetoharmafetus,n.y. times,feb.27,2004,ata15;carl hulse, senate outlaws injury to fetus during a crime, n.y. times, mar. 25, 2004, at ai. 65. wiersma v. maple leaf farms, 543 n.w.2d 787,791 (s.d. 1996). 2005] prenatal testing gone awry 209 immunize a wrongdoer from liability.'o66 in essence, denying any civil liability to the tortfeasor for injuring a fetus is raising protection of the tortfeasor above the woman's fourteenth amendment right to privacy. the farley court also observed the social justice and policy benefits in recognizing there is no difference between a quick and a viable fetus and that parents have suffered a loss regardless ofthe fetus' age.67 [j]ustice is denied when a tortfeasor is permitted to walk away with impunity because of the happenstance that the unborn child had not yet reached viability at the time of death. the societal and parental loss is egregious regardless of the state of fetal development. our concern reflects the fundamental value determination of our society that life--old, young, and prospective-should not be wrongfully taken away.68 the farley court supported this position in stating ''the overriding importance of the interest that we have identified merits judicial recognition and protection by imposing the most liberal means of recovery that our law permits.'>69 further, the viability standard, which has kept many states from recog­ nizing fetal wrongful death, is "outmoded in tort law.''70 "viability as a developmental turning point was embraced in abortion cases to balance the privacy rights of a mother as against her unborn child. for any other purpose, viability is purely an arbitrary milestone from which to reckon a child's legal existence.''71 losing a potential family member due to the tortious conduct of another person causes the woman and family an injury and pain of the same order as when it loses an existing member. 72 e. the issue should not die . .. do not rely on medical malpractice despite the arguments in support of wrongful death, it is not likely to become accepted by a majority of states without an abolition of the viability standard because there is no good standard to determine viability. further, it is not likely that the more liberal states will entertain the notion of introducing it, especially in states with lenient laws that permit abortions into the second 66. david kader, thelawoftortiousprenataldeathsinceroev. wade,45mo.l.rev. 639,657 (1980). 67. farley, 466 s.e.2d at 533. 68. /d. 69. /d. 70. wiersma, 543 n.w .2d at 792. 71. /d. 72. 66 fed. credit union v. tucker, 853 so.2d 104,107 (miss. 2003). 210 indiana iiealtii law review [vol. 2:199 and third trimesters. however, states should be persuaded by west virginia and south dakota, which have taken steps to eliminate the barrier of viability in allowing wrongful death claims through case law, and states like nebraska that })ave done it statutorily. a woman will not feel the loss of her fetus any less because her fetus is not yet ''viable." in states that do not recognize f~tal wrongful death and that have undergone medical malpractice refonn to lqnit claims· and tighten recovery caps, women in those states who have been harmed in a medical setting will have little potential for successful recovery. while it is true lawsuits are filed often in this country and manyjuris­ diction's courts are flooded with cases, such a reason is not a valid excuse to essentially "ignore" a tort because it has been historically too difficult to deter­ mine.· in actuality, the arena of medical malpractice has become something like a three-ring circus, especially in states that have .been labeled "crisis" states. wrongful death claims are not nearly as time consuming on :the courts simply because they do not involve the expansive procedural mandates that accompany medical malpractice claims. adopting wrongful death is a good choice to make for the states that have been faced with an onslaught of medical malpractice litigation. · however, the problems associated with viability should not prevent a court from recognizing the tort of fetal wrongful death in the case of an unnecessary abortion due to the physician's recommendation. in rambo v. lawson, the missouri court of appeals noted it understood there is a heightened difficulty in proving that a nonviable fetus was in fact alive at the time of the injury in order to prove causation, but"[ d]ifficulty of proof has no bearing on the existence of a cause ofaction."73 ill. medical malpractice for a fetal death much of the rise in malpractice insurance premiums in recent years has been attributed to obstetricians. medical malpractice has become the accepted tort under which to try cases of this nature, although the recent trend toward caps in potential recovery could see a limitation on the situations in which one could recover and the amount that is recoverable. these recent developments could lead to medical malpractice offering even less possibility for recovery by women but, yet it is a more viable option than recovery under wrongful death and the only option in many states with respect to fetal recovery. 73. rambo v. lawson, no. wd 41747, 1990 wl 54277, at •5 (mo. ct. app. may 1, 1990). the supreme court ofmissouri affirmed tbis holding initially, but the court was forced to hold differently in connor v. monkem, following the passage of legislation in missouri stating life begins at conception. conner v. monkem co., inc., 898 s. w .2d 89, 92 (mo. 1995). the connor court said the rambo holding was not to applyto cases following the effective date of the statute. conner, 898 s.w.2d at 93. the court also pointed out that in holding that such a cause of action could exist did not mean that a party would ever be successful in proving a claim. /d. 2005] prenatal testing gone awry 211 a. standard of care of an obstetrician/gynecologist the standard of care for an obstetrician/gynecologist (ob/gyn) is not necessarily different from any other type of physician. "[a] physician is under a duty to use that degree of care and skill which is expected of a reasonably competent practitioner in the same class to which he belongs, acting in the same or similar circumstances."74 massachusetts adds the condition that one has to consider the advances in the profession and the resources available to the physician.75 although a court does not have to treat ob/gyns any dif­ ferently than other types of physicians, a court is allowed to take their specia­ lized training into account. "under this standard, advances in the profession, availability of facilities, specialization or general practice, proximity of specialists and special facilities, together with all other relevant considerations, are to be taken into account. "76 b. burden of proof: medical malpractice claims states tend to differ on the elements that must be met to satisfy the burden of proof for medical malpractice claims. missouri courts have held three elements must be satisfied to have a prima facie case of medical mal­ practice: "1) an act or omission of the defendant which failed to meet the requisite medical standard of care; 2) that the act or omission was performed negligently; and 3) a causal connection between the act or omission and the plaintiff's injury.'m similarly, georgia courts also recognize three elements necessary for medical malpractice: 1) the duty that naturally arises from a physician-patient relationship; 2) a breach in that duty by abandoning the requisite standard of care; and 3) that the breach was the proximate cause of the injury.78 georgia's requirements fall neatly within the :framework of torts learned in ftrst-year coursework, 79 yet missouri introduces the requirement that the act or omission in question be performed negligently, which would be more difficult to prove or attain rather than a mere breach of a duty. also, in missouri's first element, "duty'' is somewhat veiled under the wording of "requisite medical standard of care.'.so this suggests missouri is not looking for a personal duty to a particular patient, but that a medical professional's duty is generally implicit in the medical standard of care. 74. shilkret v. annapolis emergency hosp. ass'n., 349 a.2d 245, 253 (md. 1975). 75. stepakotfv. kantar, 473 n.e.2d 1131 (mass. 1985). 76. shilkret, 349 a.2d at 253. 77. baker v. gordon, 759 s.w.2d 87,91 (mo. ct. app. 1988). 78. breyne v. potter, 574 s.e.2d 916, 919-20 (ga. ct app. 2002). 79. basic tort law involves proving there is a duty between the two parties, a breach of that duty, and the breach was the cause of the injury. 80. baker, 159 s.w.2d at 91. 212 indiana health law review [vol. 2:199 beyond the elements which appear in case law, states have codified procedural guidelines for filing medical malpractice claims. for many states, especially those which have tried to control the rise in medical malpractice claims, these strict and often lengthy procedural guidelines are likely enacted to curb the filing of frivolous claims. indiana's procedure is similar to states such as louisiana and nebraska. 81 under indiana law, a medical review panel may be convened after the claim has been filed, and the panel consists of one attorney, who acts as the chairman of the panel, and three medical profes­ sionals, who must be licensed in their respective fields and may not be a health facility administrator. 82 the panel receives evidence and information from the respective parties. the panel's report, based on the evidence submitted to them by the parties, is due 180 days after the last person joined the panel. although the report is admissible as evidence at trial, the panel's report is not controlling or binding upon the court in any way, and it does not even have to be used at trial. 83 the panelists are to be compensated for their time, which roughly equates to expert testimony fees. 84 however, the goal of the medical review panel is to provide an objective opinion based on input from both the legal profession and the medical profession. also, the time consuming nature of this exercise would likely deter some people from wanting to proceed with this route, as it will likely drive up litigation costs. c. the benefits of medical malpractice medical malpractice is likely a more successful claim for the woman filing a claim for an abortion based on the incorrect recommendation of the woman's ob/gyn. medical malpractice usually involves physician error or oversight, which is clearly evident in breyne v. potter, where the physician misread the test results twice. 85 the duty of the physician is easier to deter­ mine than the viability of a fetus, as viability is the standard that keeps many states from recognizing wrongful death in fetuses. in the breyne case, the woman's expert witness testified that the physician "deviated from the stand­ ards of care ... by failing to accurately counsel [the woman] concerning the findings," and this deviation deprived her of the chance to make an informed choice and led her to choose an unnecessary abortion. 86 81. la. rev. stat. ann. § 40:1299.39.1 (west 2004); neb. rev. stat. § 44-2825 (1993). 82. ind. code§ 34-18-10 (2003). in nebraska. the attorney member of the panel is a nonvoting member of the panel. neb. rev. stat.§ 44-2841(1) (2003). 83. ind. code§ 34-18-10 (2003). 84. /d. 85. breyne v. potter, 574 s.e.2d 916, 918 (ga. ct. app. 2002). 86. /d. at 919. 2005] prenatal testjnggoneawry 213 further, many, if not all, states have specific procedures for medical malpractice, and medical malpractice is a widely practiced and utilized area of law. some mechanism is needed to hold physicians to the standard of duty, and in a situation like the breyne case, medical malpractice emphasizes the breach of duty of the physician. d. medical malpractice: criticized on so many fronts the prominence of medical malpractice claims in the united states has received a lot of attention from the media and legal scholars alike. conse­ quently, pressure is rising to cap malpractice suits as one method of cost-con­ tainment for health care, and many states have began to limit the amounts of recovery possible from medical malpractice suits.87 for example, louisiana has capped the potential recovery for medical malpractice at $500,000, but it allows the court to retain jurisdiction over the matter to make determinations regarding the reimbursement of future medical payments if the court grants permission for that consideration in its initial judgment 88 in response to the increase in claims, insurance companies have responded by drastically increas­ ing coverage rates for physicians, and ob/gyns often top the list of the highest insurance premiums. the increase has made many physicians overly sensitive and anxious about the possibility of being sued. even before the malpractice insurance rates began to rise, there was a suggestion this type of problem might occur as a consequence of allowing recovery in the first place. a natural response of ob/gyns, in an attempt to avoid any risk of malpractice liability, is to over-utilize prenatal diagnostic testing.89 however, ordering excessive tests does nothing but raise the costs of health care even more, which is one of the main driving forces of the states who have taken steps to limit medical malpractice in the first place. until more states have implemented monetary limits for recovery on medical malpractice to protect the ob/gyns, the health care system will continue to strain under the weight of ob/gyns and all physicians being overly cautious. 87. introduced by the senate in 2004, the healthy mother and healthy babies access to care act sought to limit punitive damages "against any person named in a health care lawsuit only ifit proven by clear and convincing evidence that such person acted with malicious intent." s. 2061, 108th cong. § 6(a)(1) (2004). the bill also sought to cap non-economic damages at $250,000. s. 2061, 108th cong. § 3(c) (2004). with respect to state action, over the past eighteen months, florida, mississippi, nevada, ohio, oklahoma and texas have passed tort reform legislation in an attempt to curb malpractice insurance rates. the americans for insurance reform group suggest since these states did not see a drop in insurance rates following the passage of their respective laws, the problem lies more in the insurance industry than in the legal arena or health care arena. americans for insurance reform, limiting liability will not fix insurance problems, at ht1p:llwww.insurance-reform.orglpr/aircaps%20then %20rate% 20hikes.pdf(updated apr. 2004) (on file with the indiana health law review). 88. la. rev. stat. ann.§ 40:1299.39(f) (west 2004). 89. alexander morgan capron, tort liability in genetic counseling, 19 colum. l. rev. 618, 661 (1979). 214 indiana health law review [vol. 2:199 additionally, there might be a problem with causation, which is one of the requirements in many states for a medical malpractice claim. the physi­ cian's negligence is not the proximate cause of the fetus's condition. the fetus's condition is the uncontrollable result of genetics. the physician's alleged negligence in failing to detect the abnormality or genetic defect from the prenatal test is not quite the same scenario as the situation in which a physician has failed to make a timely diagnosis of a curable disease. the aftliction the child must live with "is an inexorable result of conception and birth."90 e. medical malpractice: it's fine for now nevertheless, the physician's involvement in the breyne case and other similar situations is one of more direct causation. true, the physician may not have anything to do with the child's genetic make-up, but a woman's obstetri­ cian is the person the woman entrusts to advise her on the best course ,of treat­ ment or action during her pregnancy. if a woman terminates the pregnancy because her physician informed her she would have a child with severe defects, and the physician turned out to be carelessly wrong, the physician is within the chain of causation. the woman would testify if she had not been told of the abnormality she would not have elected pregnancy termination. in the push to reform the tort of medical malpractice, it is possible to lose sight of the patients' role in the situation. true, the rise of medical malpractice has led to the rise of insurance premiums, but consider the probable reason for those large increases: hospitals have to raise rates to. cover in kind services to people who cannot pay. it would be an injustice for the hospitals and subse­ quently, society as a whole; to bear the costs of other people's wrongdoing. "to deny recovery, as the courts have, because professional liability would otherwise be greatly increased is merely to pretend that the costs created by professionals' wrongful conduct do not exist ... they are merely less visible, being borne by the victims or by the state and other groups in society. ';91 the other major factor that is forgotten in medical malpractice is the ter­ mination of the pregnancy. medical malpractice is better suited to cases in which the doctor operates on the wrong extremity, but when the malpractice is a loss of life, there does not seem to be the completeness of recovery or the closure that may come from a wrongful death suit wrongful death acknow­ ledges the potential of human life, and medical malpractice merely chastises human error. 90. grubbsv.barbourvillefamilyhealtb.ctr.,120s.w.3d682,689(ky.2003)(quoting becker v. schwartz, 386 n.e.2d 807, 816 (n.y. 1978)). 91. capron, supra note 89, at 684. 2005] prenatal testing gone awry 215 n. does the right to choose preclude the right to sue? a. the effect of the woman's voluntary abortion perhaps the most significant component of the breyne v. potter case is the ethical conflict that came into play regarding the woman's choice to abort the fetus. 92 · there is an ethical dilemma with regard to what extent· the woman's 'choice to terminate the pregnancy affects the wrongful death claim or the medical malpractice claim in states that do not recognize wrongful death. the conflict centers largely around the designation of the fetus. states that recognize fetal wrongful death, like georgia, do so on the premise that the fetus is a person or at the very least, an independent being from its woman. however, this philosophy contradicts the reasoning of the supreme court's interpretation of an unborn child's status in roe v. wade.93 the roe court held an 'unborn child is not a person to the specific terms of the fourteenth amendment, yet it seemed to acknowledge the difference between the designa­ tions of a person necessary to support both wrongful death and abortion. 94 author sheryl a. symonds explains the roe court's reasoning behind distin­ guishing the policy motives behind wrongful death and abortion: [t]he decision to allow abortion does not depend on the same policies and justifications as does the decision to allow a cause of action for the wrongful death of a fetus. while the fetus may not be a ''person" for the purposes of the fourteenth amendment, it may be a ''person" for the purposes of a states' wrongful death statute. furthermore, while a woman's right to privacy is the policy involved in the abortion decision, the policy that a tortfeasor should not escape liability is involved in the wrongful death decision. one decision does not solve the controversy of the other.95 b. another conflict over viability although it appears the roe court tried to preserve the possibility of a world in which wrongful death suits and the choice to have an abortion can coexist, there is one common theme running through both wrongful death and abortion-viability. with the exception of south dakota and west virginia, 92. breyne v. potter, 574 s.e.2d 916 (ga. ct app. 2002). abortions for some clinical reason, like a health problem or an identified genetic disease,. account for approximately two percent of all abortions performed in the united states annually. klasing, supra note 49, at 973. 93. roev. wade,410u.s.ll3 (1973). 94. id. at 158. 95. farleyv. sartin,466s.e.2d522,534-5 (quoting sheryl a symonds, wrongfuldeath of the fetus: viability is not a viable distinction, 8 u. puget sound l. rev. 103, 113 (1984)). 216 indiana heal1h law review [vol. 2:199 viability is a requisite for most states' wrongful death claims.96 '"[v]iability' as a developmental turning point, was embraced in abortion cases to balance the privacy rights of a woman as against her unborn child. for any other purpose, viability is purely an arbitrary milestone from which to reckon a child's legal existence.',g7 further, the supreme court revisited the idea of viability and the trimester framework in planned parenthood v. casey in 1992.98 viability was recognized as a crucial element of the roe holding, which was affirmed by the casey court: "subsequent to viability, the state in promoting its interest in the potentiality of human life may, if it chooses, regulate, and even proscribe, abortion except where it is necessary, in appropriate medical judgment, for the preservation of the life or health of the mother.',gg however, the casey court rejected the "rigid trimester framework" of roe and held the "undue burden" standard is more appropriate. 100 according to the court, an undue burden exists if something becomes a substantial obstacle or interference to the mother being able to obtain an abortion before the viability of the fetus, unless the life of the mother is in jeopardy. 101 the casey court acknowledged the importance of stare decisis with respect to the roe decision since it has become the foundation of much of the abortion law in this country, but it could be argued that in doing so, it did nothing but confuse the matter even further. the viability standard, which is the lucid element on which many prenatal torts lie, was not eliminated but rather nearly exalted in casey. stare decisis does little for a jurisprudence if that law is of little help to legislatures and lower courts in applying the rule. at least the trimester framework provided concrete dates on which a court could rely. instead, the abolition of the trimester framework in casey did nothing but frustrate the purpose, as now, more than ever, the issue of viability is left to the speculation of individual states and courts, which may ruin the effect of roe more than overruling it. c. is the woman contributorily negligent? irrespective of the viability issue, the woman's decision to have an abortion can potentially affect the alleged negligence of the physician. the georgia court of appeals held in roseberry v. brooks that the physician's negligence is superseded by a woman's choice to have an abortion.102 in 96. see part ii.c, supra. 97. 66 fed. credit union v. tucker, 853 so.2d 104,114 (miss. 2003) (quoting wiersma v. maple leaffanns, 543 n.w.2d 787, 792 (s.d. 1996)). . 98. planned parenthood v. casey, 505 u.s. 833 (1992). 99. id at 838 (quoting roe v. wade, 410 u.s. 113, 164-65 (1973)). 100. id 101. ld. 102. roseberry v. brooks, 461 s.e.2d 262,267 (ga. ct. app. 1995). 2005] prenatal l'estinggoneawry 217 roseberry, the woman's primary care physician recommended that she have an abortion based on his belief that the fetus would likely die due to the woman's liver disease.103 the physician did not consult with an obstetrician prior to giving the woman this advice, and she had an abortion based· on· his recommendation. 104 later, it was determined her treatment for the liver disease probably would not have damaged the baby, but the court held that "any medical negligence attributable to [the physician] is superseded· by··the mother's volitional act as the proximate cause of the death of the fetus/'1os the court reasoned the woman's act created a problem with ca'usation, stating "[t]he lawful abortion performed for that purpose [for the woman to undergo cancer treatment] is an intervening act which effectively caused the entire injury (death) to the unborn [fetus]. "106 the physician was not the proxi­ mate cause of the fetus' end of potential life. 107 conversely, a michigan physician did not escape liability in barnes v. vettraino}08 in barnes, the woman had an amniocentesis due to her age, which was thirty-six. there was a delay in the results being relayed to her; and when she finally received the results, she learned the baby had various birth defects. michigan law prevented her from having an abortion because of the fetus's gestational age, so the woman traveled to a different state for the abor­ tion, and she suffered complications from the procedure. she filed a claim based on the costs associated with the abortion and did not file an express claim of wrongful death. 109 the barnes court noted the parents were seeking medical malpractice damages "for economic and non-economic losses attri­ butable to a medical provider's pwported negligent diagnosis and treatment," and held that just because "these losses arose in the context of an abortion does not prevent the plaintiffs from pursuing compensation."110 however, the court was very deliberate to clarify the damages granted to the parents did not establish a ''wrongful infliction of abortion" cause of action.111 the barnes court limited the holding of its previous decision in taylor v. kurapati. 112 taylor held the state "has no obligation to take the affirmative 103. id at 267. 104. ld. 105. id. 106. id. 107. roseberryv. brooks,461 s.e.2d 262,267 (ga. ct. app. 1995). 108. barnes v. vettraino, no. 235357,2003 mich. app. lexis 801 (mich. ct. app. mar. 25, 2003). 109. id at *1-2. 110. ld. at *7. 111. ld. 112. taylorv.kurapati,600n.w.2d670(mich.ct.app.1999). in taylor, thewoman's initial ultrasound was interpreted by her ob/gyn, who indicated that there were no problems.· the second ultrasound was performed and interpreted by another physician, who indicated to the mother that she might want to have a high-resolution ultrasound because she could not identify the fetus's femurs. the mother refused, since her ob/gyn previously told her the baby merely had short femurs. the baby was born missing a femur, shoulder, fingers and with several fused joints. id at 673-74. 218 indiana realm law review [vol. 2:199 step of imposing civil liability on a party for failing to provide a pregnant woman. with information that would make her more likely to have an elective, and eugenic, abortion," because the state does not have to assist a woman who wants an abortion by paying for it.113 · the taylor court recognized the ethical conflict between abortion and wrongful death, stating that "[t]here would be an inherent conflict in giving the woman the right to terminate the pregnancy yet holding that an action may be brought on behalf of the same fetus under the wrongful death act" for the negligent act of the third party. 114 however, it is possible that the "conflict," to which the taylor court refers and the reason for the barnes court's careful limitation of its decision to medical malpractice (rather than wrongful death), is non-existent in modem jurisprudence. wrongful death actions for a fetus and an abortion might be able to coexist, especially because "[t]he irrelevance of roe v. wade to the question of recovery for the wrongful death of a stillborn fetus may be inferred from the numerous post-roe decisions which do not rely on it in any re­ spect .... " 115 further, roe bases its interpretation of person on the fourteenth amendment, which is nineteenth century law. the framers of the consti­ tution and those who have since amended it have all intended for the inter­ pretation of the document to be flexible and capable of withstanding changes in society, including changes in the medical landscape that might allow for a broader definition of person. finally, as aforementioned in this part, roe itself notes there is a difference in the definition of person for the purposes of wrongful death and for abortiony6 society may be better off if all aspects of the law (case law, 113. /d. at 687. this view of the taylor court seems to ignore the whole idea of informed consent, which was in existence in the context of abortion at the time of this decision. at the time of the taylor decision, michigan had an informed consent law concerning abortion proce­ dure, which would essentially prevent any patient from having an "elective" abortion, as it requires the mother to undergo certain steps and sign various release forms before she has an abortion. mich. comp. laws ann.§ 333.17015 (west2003). similar informed consent was missing in the taylor case, which failed to recognize the failure of the physician in this case. case law in michigan suggests that the question whether an abortion should be performed in the first trimester is left to the discretion of the physician. see, people v. nixon, 201 n.w.2d 635 (mich. ct. app. 1972). however, following the passage of the informed consent statute specifically concerning abortion, it would seem the physician should have a duty to inform the woman of the option to terminate the pregnancy in a non-coercive manner and let her have the benefit of making the decision herself: rather than essentially having the physician do it for her. this lack of correct information led the woman in the taylor case to deliver a child she would have terminated and the woman in the breyne case to terminate a pregnancy of a normal fetus. 114. kader,supranote66, at657 (quotingtothv. goree,237n.w.2d297,301 (mich. ct. app. 1975)). "[a]bortion involves the 'intentional, consensual act by a woman and her physician, which the law specifically allows,' and since the law allows it, the law should protect the woman whose consent was given based on misinformation. klasing, supra note 44, at 971. 115. kader, supra note 66, at 651. 116. roe v. wade, 410 u.s. 113, 162 (1973); see also, sheryl a. symonds, wrongful death of the fetus: viability is nota viable distinction, 8 u. puget soundl.rev. 103, 113 (1984). 2005] prenatal testing gone a wry 219 statutes and policy) recognize "it may be necessary to accept some incon­ sistency and conclude that prenatal life will be protected against intentional or negligent interference, absent .some compelling countervailing interest on the part of another."117 the physician would have to prove that there was some "compelling countervailing interest" that prevented him or her from:acting accordingly. applying this standard to the breyne case might lead to th~,con~ elusion the physician's mistake in reading the laboratory report wasr,not a compelling interest to protect the life or interest of the fetus. : · '·. · d. prenatal genetic testing and abortion this "compelling countervailing interest" standard might lead physicians to adopt a new standard in which they do not order any prenatal testing, reasoning that as physicians, their only compelling interest is to protect the life of its patient (here, the fetus). it could be argued that standards of care· are constantly evolving which would permit a rapid change in the standard of pre­ natal care. also, advances in genetic mapping have put strains on prenatal testing from the standpoint that it gives women too much information that may not be completely accurate. a better solution to this problem, rather than wastingjudicial time with a whole new set of claims of women's privacy violations, is to preclude any physician liability based on anything related to a prenatal test or eliminate the standardized practice of recommending abortions based on prenatal tests. in simmons v. w. covina med. clinic, 118 a california appellate court realized the genetic test is not foolproof in simmons, a woman's physician failed to administer an afp test, and her son was born with down's syndrome.119 the woman said if she had known her child would have been born with down's syndrome, she would have terminated the pregnancy. nonetheless, the court noted the afp test was initially administered to detect neural tube defects like spina bifida and only recently was it discovered that in twenty percent of cases involving women under thirty five years of age, 120 the test could. identify factors indicative of the possibility ofhaving children with down's syndrome. the court held these percentages were not strong enough to attach liability to the physician. 121 it is unlikely the practice of aborting a fetus based on the result of a prenatal test will be eliminated. however, if the choice is made to terminate 117. kader, supra note 66, at 660. 118. simmons v. w. covina med. clinic, 212 cal. app. 3d 696 (cal. ct. app. 1989). 119. id at 699. 120. the age is significant in this case because at the time of this decision, amniocentesis was typically only performed on women over the age of thirty-five. afp testing, which is performed on all pregnant women, was a younger woman's only possibility for detection of the risk for down's syndrome, and even then the afp test did not detect the presence ofdown's syndrome in all cases. id. at 700. 121. id. at 696. 220 indiana health law review [vol. 2:199 the pregnancy based on the result of a prenatal.test, "[ e ]very effort should be made to confirm the chromosome abnormality in the abortus itself."122 con­ firming the abnormality is important to the extent that further tests can be con­ ducted to determine whether the parents are carriers of a gene. the medical analysis is important research into the genetic make-up, which could further the advances of the human genome project. further, pathological analyses are routine in this country to confirm a diagnosis or to learn more about an affliction. even though parents can have a difficult time understanding the purpose of the pathological testing and it can potentially create problems for physician liability, it is unlikely the practice will end due to its research benefits. e. the doctor's only choice is to be more careful abortion is a difficult decision under any circumstance, and for women and families faced with the uncertainty of having a severely deformed child, it appears like the best option to some women. to have that mindset confirmed by the woman's physician (that the pregnancy should be termi­ nated) would be the only words some women would need to hear if they were unsure about their feelings. society tends to usually place a high level of confidence in their physi­ cian's opinion, especially when faced with such a decision of grave conse­ quences. the physician's recommendation to terminate the preg~!ancy will help give some form of closure to a woman and validation for her decision. if this recommendation turns out to be faulty and the baby was in fact healthy at the time of termination, similar to the situation in the breyne case, a woman should be allowed to recover from the termination that would not have happened but for the physician's recommendation. "[t]he fact that the [death] in question occurred at the time of the therapeutic abortion does not preclude [a woman] from maintaining this action if the trier of fact concludes that said abortion was necessitated because of injuries sustained as a result of the negli­ gence of appellees."123 here, the injury is not a physical, battery-like injury, but the injury is a recommendation by a trusted physician to terminate the pregnancy. if physician • s negligence is truly the major motivating factor in a deci­ sion to terminate the pregnancy; that is, the parents did not reach the decision by themselves, then the physician • s negligence should not be superseded by the woman • s choice of termination. the physician should be held not only to a duty to give information about all options but to ensure the information is correct, or otherwise there is a lack of"informed consent." as long as women have the right to choose to have an abortion, which stems from a fundamental 122. priest & rao,supranote 15, at211.. 123. shirley v. bacon, 267 s.e.2d 809, 811 (ga. ct. app. 1980). 2005] prenatal testing gone awry 221 right to privacy, that right should be protected up until viability, and the severity of its consequences should be considered and respected by obstetri· cians who must tread in its murky waters. v. can the lab or genetic counselor doing analysis be held jointly/severally liable? although it appears steps are being taken towards allowing a separate cause of action for a fetus, pending medical malpractice legislation could result in a cap being placed on the maximum potential recovery for an ob/gyn. this would greatly limit the possibility for recovery from ob/gyns for a fetus with newly gained legal recognition, at least for federal crimes.124 the result of this event could make the lab conducting the genetic testing or the genetic counselor who meets with the parents more vulnerable to lawsuits. even when the genetic counseling was in its formative stages, there was a movement to hold genetic counselors to a similar duty as other medical professionals, although noting that some exceptions might have to be made since they can possess a different education background than physicians.125 further, if the problem with the prenatal test is traced not to the physi­ cian's oversight but rather to faulty equipment used to obtain the sample or analyze the sample, this would not be a claim under medical malpractice but would fall under general negligence or product liability. for example, indiana's medical malpractice statutes only apply to medical judgments by professionals.126 this is beneficial to the women because it could allow them to escape the caps that some states have imposed on recovery for medical mal­ practice claims. in indiana, it appears there would be a cause of action against the genetic counselor and his/her employer under traditional medical negligence. in bader v. johnson, a woman who had previously given birth to a child with hydrocephalus consulted a genetic counselor for an amniocentesis and an ultra­ sound, based on the fact that if she was carrying a similarly aftlicted child in this pregnancy, she would terminate the pregnancy. while the amniocentesis revealed no abnormalities, the ultrasound indicated a possibility of hydro­ cephalus because the fetus had a large head. the woman was supposed to return to talk to the counselor, but an office error caused her to not be sche­ duled for a follow-up appointment her ''treating physician" performed another ultrasound at thirty-three weeks, which confirmed the fetus had hydro­ cephaly, but it was too late for an abortion. the child died at the age of four months, and the parents sued the genetic counselor and the laboratory/practice 124. see part ii.d. supra. 125. genetic counselors typically have a master's degree in genetic counseling and their bachelor's degrees typically are in either the sciences or psychology. they must also be board certified by the american board of genetic counselors. malinowski, supra note 12, at 1459. 126. ind. code§ 34-18-12-18 (2003). 222 indiana health law review [vol. 2:199 as a whole. 127 in their complaint, the couple alleged "they consulted health­ care providers to obtain information having a direct bearing on [the woman's] health, namely: a decision to terminate the pregnancy."128 the ultrasound was · eonducted by healthcare providers revealing pre-natal abnormalities. the couple relied on the results of the ultrasound to make their informed deci&ion. the lridiana supreme court stated "[a]s a matter oflaw healthcare-providers ·ow'ed<a duty to the [couple] to disclose the result of the test"129 and.failing ''to -allow the [couple] to proceed with their claim would 'immunize those in the medical field from liability for their performance in one particular area of medical practice. "'130 the delaware supreme court concurs with indiana's result, "recogniz­ ing a cause of action for negligent performance or delay in diagnostic testing for birth defects, either under the guise of traditional tort analysis or 'wrongful birth. '"131 louisiana's malpractice liability for state services act would pro­ vide that laboratories in state-operated medical facilities could be held vicari­ ously liable, but the $500,000 cap on awards for damages would apply com­ prehensively to all involved parties in the action.132 conversely, there are strong policy arguments to support that prenatal diagnostic laboratories and their genetic counselors should not be·-held liable for faulty test results. the lab employees do not have the same. skill and education as the physicians do. genetic counselors, who are usually employed by the labs analyzing the tests, typically have undergraduate degrees in some discipline of science, they have a master's degree in genetic counseling, and they have to be board-certified by the american board of genetic counse­ lors. 133 also, the diagnostic labs themselves are highly sensitive to the legal and medical liability associated with genetic testing. if there is any question about the quality of the specimen that has been obtained or a question about the process of the analysis, the lab will usually recommend a follow-up or repeat test just to be safe. 134 it appears while the prenatal diagnostic laboratories can be held jointly liable, with some states like louisiana mandating that the medical malpractice 127. bader v. johnson, 732 n.e.2d 1212, 1215-16 (ind. 2000). 128. id.at 1217. 129. id. 130. id. at 1219 (quoting garrison v. foy, 486 n.e.2d 5, 8 (ind. ct. app. 1985)); 131. garrison v. med. ctr. of delaware, inc.; 581 a.2d 288, 292 (del. 1989). 132. la. rev. stat. ann. § 40:1299.39(a), (f) (west 2004). based upon louisiana courts' applications of the statute, the cap would apply both to staff employees of the hospital or contracted staff of the hospital. therefore, if the ob/gyn was on the hospital staff or on contract with the hospital, then the maximum allowed fur recovery would be $500,000. how­ ever, if the state-funded laboratory is merely the only testing filcility in the area to which all tests are sent and the physician has no connection with the facility, it is unclear whether a separate cap would be possible for the laboratory and the ob/gyn. 133. malinowski, supra note 12, at 1459. 134. id. at 1465. 2005] prenatal testing gone awry 223 damage cap apply to all liable parties, m public policy would discourage the possibility of holding the labs severally liable unless a strong showing could be made of intentional negligence on the part of the laboratory. this position insulates the laboratory and its employees to a certain extent by recognizing their level of education is usually less than that of a physician. this position would greatly help in situations like the breyne case. the diagnostic labora­ tory had properly performed the genetic test; it was the physician that misread the results. it is not likely there would be a completely separate cause of liability because, typically, as in the breyne case, the woman's ob/gyn is involved in the process, either in administering the prenatal test or discussing the results with the woman. as genetic counselors become more prominent in the field of genetic testing and as prenatal genetic testing stands to greatly expand its potential <;lue to the human genome project, there will be more pressure on the genetic counselors and prenatal diagnostic laboratories. the result is their roles in the process could become more prominent and certainly expanded. the scope of their duty and the level of their education should be addressed, including the possibility of mandating a medical degree or at least specialized medical training. vi. conclusion breyne v. potter is only the beginning of this issue. as the human genome project draws to a close, that information is going to begin to appear within the context of prenatal genetic testing. scientists are undoubtedly going to identify more chromosomal abnormalities that can be detected through already-utilized prenatal testing methods. this will naturally lead to more instances for misdiagnosis or misinterpretation, either by the physician or the prenatal diagnostic laboratory and could open the door for more healthy fetuses aborted based on the belief they had a gross genetic abnormality. as technology develops, the law has to be able to appropriately respond to situations in which technology leads to unfortunate results. the opportunity for abortion exists in our society, and a woman's right to choose to have an abortion has been recognized as a fundamental right stemming from her right to privacy. supreme court cases in the years following roe v. wade have sought to refine that right, and the right now hinges on a determination of viability, rather than a trimester framework. this is where the issue becomes problematic: viability is often the benchmark by which states determine whether there is a possibility for recovery under the tort of wrongful death for a fetus. depending on what state a woman lives in, her right to choose to terminate her pregnancy occurs sooner than women in other states, depending on when the state says that a fetus is viable. this discrepancy in states' 135. la. rev. stat. ann. § 40: 1299.39(f). 224 indiana health law review [vol. 2:199 handling of viability could arguably be close to a denial of equal protection because the uniform trimester approach proposed in roe v. wade was over­ ruled by the supreme court in planned parenthood v. casey in favor of adhering to the viability issue to determine whether abortion is permitted. more states should be persuaded by those like west virginia, georgia, and south dakota who have abolished the viability standard as the main element in their wrongful death jurisprudence. in cases where the decision to terminate the pregnancy was made at the hands of a physician who negligently read test results, that termination is nothing more than what the tort implies: a wrongful death of an otherwise healthy fetus that came at the hands of the physician. medical malpractice is an acceptable means under which to bring this type of claim and is the only method to bring a claim of this type in states that do not recognize a wrongful death cause of action for a fetus. however, as tort reform continues to be a concern and on the agendas of many legislators, limits on potential recovery may not adequately compensate the victim. essentially, this allows the physician-tortfeasor to escape some of the liability for his/her actions. the mother's choice to terminate the pregnancy does not mitigate her harm in any way. her right to choose to terminate her pregnancy is not super­ seded by her physician's duty to her and her fetus. it is up to ob/gyns who are going to recommend an abortion to a woman carrying a fetus with gross genetic abnormalities to double check the results, either by having another physician or nurse look at the laboratory results or by verifying the informa­ tion with the actual laboratory. these measures only take a moment and can be the difference in a situation like the breyne case. as long as the woman has the right to choose to have an abortion, that right and its consequences must be respected by her physician through a dissemination of correct information regarding her prenatal test results. although the laboratory who analyzes the test or the genetic counselor involved in the matter may be held vicariously liable, it is unlikely that a separate cause of action will be successful against them due to their inferior education and lack of patient duty. however, all of this could change as society knows more about genetics than ever before, and it is going to affect prenatal testing. as roe and the tort of medical malpractice face uncertain futures, a woman with a similar claim to the one in the breyne case could have no judicial or statutory remedy on which to rely, which would be a great injustice. states should be prepared to reexamine fetal wrongful death with the reminder that just as the law can change, medicine will also change, and our society must look to a way in which the two can exist, respectful of each field's benefits and dangers to society. indiana health law review volume 1 issue 1 dedication eleanor d. kinney and david orentlicher, co-directors, william s. and christine s. hall center for law and health mcdonald-merrill-ketcham memorial award for excellence in law and medicine legal and ethical considerations in government compensation plans: a case study of smallpox immunization naomi seiler, holly taylor and ruth faden giving, selling, and having taken: conflicting views of organ transfer articles recent modifications to the preemption doctrine & their impact on state hmo liability laws the vagaries of informed consent prolific plaintiffs or rabid relators? recent developments in false claims act litigation governance issues for nonprofit healthcare organizations and the implications of the sarbanes-oxley act legitimate expectations, unreasonable beliefs, and legally mandated coverage of experimental therapy note hospital liability: drawing a fine line with informed consent in today's evolving health care arena 1004 h. tristram engelhardt, jr. karen a. jordan george p. smith, ii keith d. barber, david b. honig and neal a. cooper glenn t. troyer, david e. jose and andrea d. brashear leslie pickering francis shelley s. fraser indiana health law review volume 1 2004 editor-in-chief julie d. reed executive managing editor kelly j. green executive production editor leeanne r. coons executive development editor gina m. brown elizabeth a. ackmann calvin r. chambers kendra l. conover erin m. drummy david j. duncan adriane e. giltner jennifer m. hamilton theodore g. hammond j. brad kallmyer members executive notes editor shelley s. fraser executive articles· editors heidi k. hughes brian c. betner david j. lichtenberger shannon l. logsdon bryon w. miller lawren k. mills julia e. ohl natalie j. tanner cynthia m. vanvooren david l. whitsett jason l. williams faculty advisors lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz indiana healtii law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review is currently published one time per year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university school of lawindianapolis. subscriptions. current subscription rates are $10.00 per issue (domestic mailing). unless the business office receives notice to the contrary, all subscriptions will be renewed automatically. claims for non-receipt of current 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indiana university. b.a., m.a., university of southern california; ph.d., university of pittsburgh. charles r. bantz, chancellor, indiana university-purdue university-indianapolis. b.a., m.a., university of minnesota; ph.d., the ohio state university. anthony a. tarr, dean and professor of law. b.a., ll.b., university of natal; ll.m., cambridge university; ph.d., university of canterbury; ph.d., cambridge university. 'ihomas b. au.ington, associate dean for teclmology and professor of law. b.s., j.d., university of nebraska; ll.m., new york university. jeffrey w. grove, associate dean for grtllbulte studies, professor of law, and director, china summer program. a.b., juniata college; j.d., george washington university law school susanah m. mead, associate dean for academic a/fain and professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. cynthia baker. director, program on law and state government. b.a., j.d., valparaiso university. eljzabethl decoux,assistant dean for student a/fain. j.d., mississippi college school of law. angela m. espada, assistant dean for admissions. j.d., indiana university school of law-bloomington. jonna kanb macdougall, aufstant dean for extenuil a/fain. j.d., indiana university school ofj:.aw..;jndianapolis. carol b. neary, director ofdevel!jptmiit. b.a., indiana university. shannon l wttl..iams, director of professional development. b.s., indiana university. faeulty cynthia m. adams, clinical ass(]ciate professor of law. b.a., kentucky wesleyan college; j.d., indiana university school of law-indianapolis. thomas b. awngron, associate dean for technology and professor of law. b.s., j.d., university of nebraska; il...m., new york university school of law. judlih ford anspach. professor of law and director, ruth lilly law librar;y. b.s., m.l.s., kent state university; j.d., mississippi college school oflaw. boris auerbach. visiting professor of law. a.b., j.d., university of chicago. gerald l. bbpko, indiana univer.rity-purt:lue lhdversity-lndiantlpolis chancellor emeritw, indiana university tnlstu professor and projeuor of law. b.s., northern dlinois university; j.d., l1t/chicago-kent college of law; ll.m., yale law school. frank bowman, m. dale pabn.el' professor of law. b.a., colorado college; j.d., harvard law school. wlu.iam c. bradford, assistant professor of law. b.a., m.a., university of miami; ph.d., northwestern university; j.d., university of miami school of law; ll.m., harvard law school robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. cm!stek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law. daniel h. colb, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school. jeffrey 0. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. paul n. cox, centennial professor of law. b.s., utah state university; j.d., university of utah college of law; ll.m., university of virginia school of law. robin kundjs craig, associate professor of law. b.a., pomona college; m.a., the johns hopkins university; ph.d., university of california; j.d., lewis and clark law school k:ennbth d. crews, associate dean of the faculties for copyright management cmd scunuel r. rosen ·ii professor of law and professor of library and information science. b.a., northwestern university; j.d., washington university school of law; m.l.s., university of california, los angeles; ph.d., university of california. los angeles. james d. dimmu. clinical associate professor of law. b.s., indiana university; j.d., valparaiso university school of law. lenn'lf1'dl ann drobac. associate professor of law .. b.a., m.a., stanford university; ld., j.s.d., stanford law school. george e. edwards, professor of law and director; program in intematiqnal hwncm rights law. b.a., north carolina state university; j.d., harvard law school frank emmert, professor of law and eucutive direclor, center for international and comparative law. brstes 1urist:isches staarsexamen (j.d.), university of munich law school; ll..m., 'lbe university of michigan law school; ph.d., university . of maastricht; diploma, european university institute. nicholas gborgakopouu>s, professor of law. ptyhion nomikis, athens university school of law; u..m., s.j.d., harvard law school. , hllu5n grant, vuiting professor of law. b.a., u..m.~ queedsland university of technology; ph.d., university of queensland. jeffrey w .. grove, associate dean, professor of law, and direclor, china summer program. a.b., juniata college; j.d., george wasbington university law school. frances watson hardy, clinical associate professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. john lawrence hlu., professor of law. b.a., notthom dlinois university; j.d., ph.d., georgetown university. lawrence a.l'egen, m, thomas.f. sheelum professor oft ax. law and policy. a.b., beloit college; j.d., m.b.a., the university ofmicb:igan; u..m., new york university school of law. henry c. karlson, professor of law. a.b., j.d., u..m., university of dlinois college of law. · robert a. katz. associate professor of law. a.b., harvard college; j.d., university of chicago law school. lindakeu.y-hnl., professor of law. b.a., j.d., universityofvirginia. bl.banor d. kl:nnby, hall render professor of law and co-director of the wiuiam s. and christine s. hall center for law and health. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. andrew r. kl.mn, paul e. beam professor of law. b.a., university of wisconsin; j.d., emory university school of law. robert e. lancastbr. clinical a.rsociau professor of law. b.a., millsaps college; j.d., tulane law school. norman i...efs'rmn, professor of law and dean emeritus. u..b., university of dlinois college of law; ll.m., georgetown university law school. marfa pabon l6pez, assistant professor of law and co-director, latin american law program. b.a., princeton university; j.d., university of pennsylvania law school. gerard n. maouocca, assistant professor of law. b.a., stanford university; j.d., yale law school. awsonmartin, clinical associate professor law. b.s., j.d., university of dlinois. deborah mcgregor, qinical associate professor of law and assistant director of legal anal:jsis, research and communictltion. b.a.. university of evansville; j.d., georgetown university law school. susanab m. mead, associate dean and professor of law. b.a., smith college; j.d., indiana university school oflaw-indianapoli mary h. mrramu., professor of law. a.b .• butler university; j.d., cornell law school. novellan!dbff, qinicalassociate professor of law. b.a •• j.d., indiana university. james p. nehf, cleon h. foust fellow, professor of law, and director, european law program. b.a., knox college; j.d., university of north carolina law school. david or:mm.icbep., samuel r. rosen i professor of law and co-director of the william s. and christine s. hau center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical associo.te profusor of law. b.s., indiana state university; j.d., . california western school of law. antony page. assistant profeuor of law. b. comm., mcgill univetsity; m.b.a., simon fraser univetsity; j.d., stanford law school. h. katin.'een pataml, associo.te professor of law. a.b., huntington college; j.d .• university of north carolina law school; ll.m., yale law school. florence wagman rojsman, m~l d. mccormiclc i professor of law. b.a •• university of connecticut; ll..b., harvard law school. joan m. ruhr.bnber.g, clinical profeuor of law tdul director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university school of law-indianapolis. joel m. schumm, clinical as.ristant professor of law. b.a., obio wesleyan university; m.a., university of cinclddati; j.d., indiana university school of law-indianapolis. . anthony a. tarr, dean and professor of law. b.a., u..b., university of natal; ilm., cambridge university; ph.d.. university of canteibury; ph.d., cambridge university. jtjl1e-anne tar.r, visiting profeuor of law and associate dean oflntenujtional programs (new initiatives), buliana university. b.a., university of w'j.sconsin-madison; j.d., cornell university; ll.m., monash university; ph.d., university of queensland. james w; tobkb, carl m. gray profusor of law. b.s., j.d;, univetsity ofw'lscodsin. l.awrbncb p. wd.lans, wiuiam r. neak professor of law. b.a., 1he ohio state university; j.d., capital university law school; ilm., university of texas school of law. lloyd t. wtt.son, jr., associate professor of law. b.a., wabash college; m.a., duke university; j.d., indiana university school oflaw-bloomiiigton. mary t. wou, clinical professor of law and director of clinical programs. b.a., saint xavier college; j.d., university oflowa college of law. r. gborge wtuam, michasl d. mccormid h projtwor of law. a.b., univetsity of vjtginia; ph.d., indiana university; j.d., inc1iana university school of law-indianapolis. emeriti edward p. arcbep., professor of law emeritus. b.m.e., renesselaer polytechnic idstitute; j.d.,il.m., georgetown university law school james f. bajley, m. profossor of law enwrilus. a.b., j.d., m.a.ls., 1he univetsity of michigan. agnes p. barrb'tr, a.r.sociate professor of law emerita. b.s., j.d., indiana university. clyde harrison crockb'it, professor of law em«rltus. a.b., j.d., university of texas; il.m., university of london (tbe lcmdon scboo1 of economics and political science). debra a. faibndbr. profeuor of law emmta. a.b., mount holyoke college; j.d., indiana university school of law-indianapolis. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., 1he obio state university; ilm., case western reserve univetsity; ilm., columbia law school. paul j. galanti, profe88or of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. he.l.en p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. wll.llam f. harvey, carl m. gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. wll.ljam hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. wiu..iam andrew kerr, professor of law emeritus. a.b., west university; b.s., duke university; j.d., ll.m., harvard law school. wllllame. marsh. professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern dlinois university; ll.b., university ofdlinois college oflaw. kbnneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school law library faculty judrrh ford anspaci, professor of law and director, ruth lilly law library. b.s., m.ls., kent state university; j.d., mississippi college school of law. draoomir cosanici, head of reference. b.a., michigan state university; m.i.ls., university of michigan; j.d., university of kansas. debra densu.w, reference librarian. b.a., fnnk1in college; m.s., university of dlinois urbana-champaign; j.d., valparaiso univenity. mary hudson, refereru:tt/circulation librarian. b.a., ball state; m.l.s;, indiana university. riawm humphrey, reference ubrarilm. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.ls.; university ofkentnclcy. wendell e. johnting, assistant director for tedmical services. a.b., taylor university; m.ls., indiana university. chlus e. long, catalog ubraritm. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. mahnaz k. moshfegh, acquisiti<m/serials ubrarilm. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.ls., ph.d., indiana university. ml1uam a. murphy, associate director of law ubrary. b.a., purdue university; j.d., m.ls., indiana university-bloomington. kiyosm orsu, computer system specitilist. a.a., parkland college; a.b., m.s., c.a.s., university ofulinois. indiana health law review volume 1 issue 1 table of contents dedication mcdonald-merrill-ketcham memorial award for excellence in law and medicine xix history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxi recipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxiii legal and ethical considerations in government compensation plans: a case study of smallpox immunization . . . . . . . . . naomi seiler, holly taylor, ruth faden 1 giving, selling, and having taken: conflicting views of organ transfer . . . . . . . . . . . . . . . . . . h. tristram engelhardt, jr. 29 articles recent modifications to the preemption doctrine & their impact on state hmo liability laws . . . . karen a. jordan 51 the vagaries of informed consent ........... george p. smith, ii 109 prolific plaintiffs or rabid relators? recent developments in false claims act litigation .... keith d. barber, david b. honig, neal a. cooper 131 governance issues for nonprofit healthcare organizations and the implications of the sarbanes-oxley act . . . . . . glenn t. troyer, david e. jose, andrea d. brashear 175 legitimate expectations, unreasonable beliefs, and legally mandated coverage of experimental therapy .......................... leslie pickering francis 213 note hospital liability: drawing a fine line with informed consent in tooay's evolving health care arena .............................. shelley s. fraser 253 2004 eleanor dearman kinney eleanor d. kinney, j.d., m.p.h., is the hall render professor of law and co­ director of the williams. and christine s. hall center for law and health at indiana university school of law indianapolis. she is also adjunct professor of public health and adjunct professor of public and environmental affairs at indiana university. in 1999-2000, as a fulbright fellow, she was a visiting professor at the institute of latin american integration, faculty of juridical and social sciences, national university of la plata in la plata, argentina. formerly, professor kinney was assistant general counsel of the american hospital association (1982-84) and a program analyst in the office of the secretary of the u.s. department of health and human services (1979-82). professor kinney received her law degree from duke university school of law (1973) and her masters of public health from the university of north carolina school of public health (1979). professor kinney is an expert on health care financing and regulation, medical malpractice, and long term care. much of her research has been funded by foundations and government agencies, including the robert wood johnson foundation and the administrative conference of the united states. she has had several gubernatorial appointments in indiana, including service on the executive board of the indiana state department of health. she recently edited the book guide to medicare coverage decision-making and appeals (aba publishing 2002). she is also the author of many articles and the book protecting american health care consumers (duke univ. press 2002). additional information about professor kinney and the william s. and christine s. hall center for law and health at indiana university school of law indianapolis is available at http://www.indylaw.indiana.edu/centers/clhl. david orentlicher dr. david orentlicher, m.d., j.d., is samuel r. rosen professor of law and co-director of the williams. and christine s. hall center for law and health at the indiana university school of law indianapolis. he is also an adjunct professor of medicine at indiana university school of medicine and a member of the core faculty of the indiana university center for bioethics. previously, dr. orentlicher served as the director of the division of medical ethics at the american medical association, drafting guidelines on a wide range of issues, including end-of-life decision-making, health care access and rationing, reproductive decisions, organ transplantation, genetic testing, and physicians' conflicts of interest. at that time, dr. orentlicher also taught at the university of chicago law school and northwestern university medical school. a graduate of harvard medical school and harvard law school, dr. orentlicher practiced both medicine and law, each for about two years. he served on the founding board of the american association of bioethics and has been a george e. allen visiting professor of law at t. c. williams school of law, university of richmond, and a visiting decamp professor in bioethics at princeton university. ·his mostrecentbookis ma'itersoflifeanddeath(princeton univ. press 2001 ); he is also a co-author of the casebook health care law and ethics. his more than 80 articles in leading legal and medical journals address critical issues in medical ethics, including end-of-life decisions, new reproductive technologies, and managed care. in november 2002, dr. orentlicher was elected to the indiana house of representatives, where he is vice-chair of the public health committee and a member of three other committees--ways and means, education, and technology, research, and development. dedication the launch of the indiana health law review is a seminal event in the growth of the health law program at indiana university school of law indianapolis. it represents continuing commitment to the main mission of the law school's health law program-helping students learn law and policy and producing scholarship of the highest quality. certainly this first issue exempli­ fies these paramount goals of the law school's health law program and its williams. and christine s. hall center for law and health. perhaps the most wonderful fact about this new review is that, from start to finish, the review's genesis, organization, and implementation was the work of students. this year's executive board of editors developed and presented the original proposal to the faculty and have brought forth this first issue. it is rare that students who are with us for only a few years make such an impor­ tant contribution to the institution of the law school. this new law review is a tremendous contribution to the law school and its health law program. this first issue, which includes superb scholarship, is especially symbolic. it opens with an excellent article by an alumna who has had a dis­ tinguished career as a professor oflaw at the louis d. brandeis school of law at the university of louisville. following is an article by another professor who has been a long time friend and supporter of this law school. the issue contains two articles based on lectures of recipients of the mcdonald-merrill­ ketcham award. this award reflects a strong effort of the law school's health law program to reward excellence in the fields of law and medicine-an effort possible because of the generosity of good friends of the school. the issue also includes contributions from members of the bar whose firms have been long time friends and supporters of the law school's health law program, as well as national experts in health law. concluding with a strong student note bearing witness to the great capabilities of our health law students, this first issue sets a high standard for the issues to come and the indiana health law review. we close with hearty congratulations to the student staff, executive board of editors, and editor-in-chief of volume 1 of the indiana health law review. and thank you. eleanor d. kinney hall render professor of law & co-director, williams. and christine s. hall center for law and health indiana university school of law -indianapolis david orentlicher samuel r. rosen professor of law & co-director, williams. and christine s. hall center for law and health indiana university school of law indianapolis xix finally moving beyond the fiction: an overview of the recent state rally for health care reform mark e. douglas* table of contents i. lntroduction ..................................................................................... 279 ii. are statesreallysettingthe stage for federal health care reform? ................................................................ 279 a. why are the states pushing so hard? a brief recap of how we arrived here ......................................................... 279 1. costs and consequences of the uninsured ......................... 280 2. the fallout from the managed care movement ................ 282 b. the federal government's response to rising health care costs ................................................................................ 285 1. medicare modernization act: the beginning of something good? .............................................................. 286 2. deficit reduction act .......................................................... 288 3. state children's health insurance program ....................... 288 iii. states with promising universal health care reform initiatives ..................................................................................... 290 a. major movers in state health care reform ............................. 290 1. massachusetts-commonwealth care ................................ 291 2. maine-dirigo health ........................................................ 293 3. vermont-catamount health .............................................. 294 b. other promising state initiatives .............................................. 295 1. california ............................................................................ 295 2. maryland ............................................................................. 297 3. pennsylvania ....................................................................... 298 4. indiana ................................................................................ 299 5. new mexico ......................................................................... 300 iv. funding analysis-how is health reform being financed? ..................................................................................... 300 * j.d., 2008, indiana university school of lawindianapolis, indianapolis, indiana; m.s.n., 1999, indiana university, indianapolis, indiana; b.s.n., 1992, indiana university, indi­ anapolis, indiana. i would like to express my love and gratitude to my wife kelly, my son wyatt, and to my entire family for their love, support, and encouragement during law school. i would also like to thank professors eleanor kinney and david orentlicher for their support and for their continued leadership to make the hall center for law and health an internationally recognized academic institution and program. 278 indiana health law review [vol. 5:277 a. medicaid. ................................................................................... 300 b. mandated employer and consumer coverage ......................... 301 c. state taxing schemes ................................................................ 303 1. sin and tobacco taxes ....................................................... 303 2. provider and insurer taxes ................................................. 303 3. employer taxes ................................................................... 304 d. health savings accounts and high deductible health plans ............................................................................. 304 v. the stakeholders fight back ....................................................... 306 a. insurance industry .................................................................... 306 b. employers ..............• :·································································· 308 vi. an un-integrated sy~em: policy considerations to keep on the table ................................................................. 309 a. information technology ............................................................ 310 1. electronic medical records and regional health information organizations: connecting the health i '?formation dots ............................................................... 31 0 2. chronic disease management: getting control early ....... 313 3. quality measurement and tracking: excellence in care must drive reform ............................................... 315 b. revisiting the core infrastructure: patient utilization and provider capacity .................................................................... 316 1. the construction re-explosion and the subsequent reverberations ................................................................... 316 2. health provider shortage: the first stumbling block to meaningful reform .............................................. 318 3. emergency department utilization rates ........................... 320 c. bringing back the integrated delivery system: can it still work? ..................................................................... 322 1. past attempts in developing an integrated delivery system ................................................................. 322 2. primary care as the center piece for integration .............. 325 a. the patient-centered primary care "home" concept ........................................................................ 325 b. community care of north carolina: a successful primary care model ................................. 327 d. federal action that could impact state initiatives ................. 329 1. the continued erisa problem ........................................... 329 2. issues of federalism ............................................................ 331 3. prescription drug price negotiations ................................ 332 vii. conclusionare we there yet? ................................................ 333 a. reforming the collective american health care psyche .......... 334 b. we can no longer wait ........................................................... 336 2008] the recent state rally for health care reform 279 i. introduction with the number of uninsured expanding for the sixth year in a row, state governments have come under increasing political and economic pressure to take meaningful steps to put the brakes on out-of-control health care spending and address the increasing lack of access that many of their citizens face. while some states like massachusetts, maine, and vermont have taken the lead in passing comprehensive health reform, almost every state in the united states is currently considering some measure or series of measures to expand coverage to their citizens. although state reform efforts vary in size and scope, the mo­ mentum has clearly moved from a position of inertia to an outright kinetic frenzy to tackle this worsening crisis. with historic stakeholder action taking place at the grass-roots and state government levels, it appears significant fed­ eral action may finally be around the comer. further adding to this re­ energized appetite for reform, has been the fact that health care has become a contested and popular issue gaining notoriety in the 2008 presidential race. with so much energy swirling around health reform, perhaps the fictional movement that has been cloaked in "incremental steps" for the past two dec­ ades, will actually move to a factual and fundamental shift in the health care system that will provide for universal coverage for all americans. this note will re-visit some of the major themes that have emerged within the health care reform debate that has been on-going for the better part of the past two decades. the major new initiatives that have been passed or which are now under consideration and represent the best possible examples of reform efforts will be examined in more detail. part ii of this note will outline the continuing worsening affairs in the united states' health care system, will touch upon the federal government's response to the health crisis, and will dis­ cuss the by-products of the managed care era that are still relevant within the health care system today. part iii will examine the major health reform initia­ tives and discuss possible trends that may be emerging which could be applied on a national level or by other states. part iv discusses the major funding sources that are being utilized to sustain current health reform efforts. part v details the response of employers and insurers to state health care reform ef­ forts. finally, part vi discusses important policy options that must be consid­ ered as part of any comprehensive federal health reform effort. ii. are states really setting the stage for federal health care reform? a. why are the states pushing so hard? a brief recap of how we arrived here with war raging in iraq and the 2008 elections looming near, meaningful federal action regarding health reform has again been placed on hold amid the 280 indiana health law review [vol. 5:277 political posturing and rhetoric. the continued lack of federal will has ignited action by many states to reopen the testing grounds for implementing demon­ stration projects aimed at implementing health care reform ideas of their own. during this state push for reform, however, the federal government has re­ mained a vested, if not distant partner in the process preferring to let each state make its own decisions about how to best design and implement health care reform solutions. at some point in this process, with so much at stake for the national economy and with a growing number of uninsured, the federal gov­ ernment must become more involved. the federal government's continued co­ operation and collaboration will be essential in providing funding and guidance to craft solutions that make sense and are consistent with the national goals of building a sustainable, unified, and growing economy that promotes and pro­ vides for a healthier america.1 1. costs and consequences of the uninsured the recent flurry of state health care initiatives being introduced and en­ acted around the united states have been long awaited by many, and have cre­ ated a renewed buzz that universal health care reform may actually be realized in the near future. although reform efforts have been incrementally moving towards a "universal-like" solution over the past two decades, there has been a recurring failure of leadership by the federal government to take significant steps towards creating a health care system where every citizen can purchase or have access to affordable health care.2 in the mean time, states have slowly been taking action, tackling the complex issues created by the increasing num­ ber of uninsured and escalating health costs. the new state plans come at a time when the health care crisis is in an ever worsening state. health care con­ tinues to sap the united states' economic strength with health care costs rising to over sixteen percent of the gross domestic product ("gdp") in 2004.3 health 1. theodore r. mannor & jonathan oberlander, paths to universal health insurance: progressive lessons from the past for the future, u. ill. l. rev. 205,217,229 (2004) (dis­ cussing that regardless of the plan that emerges, the federal government will have shared author­ ity over the states either as coordinator of services or as provider of oversight for funds distributed to each state for health reform purposes). 2. see barry r. furrow, thomas l. greaney, sandra h. johnson, timotiiy s. jost & robert l. schwartz, dffi law of heal til care organization and finance 136 (5th ed. 2003) [hereinafter furrow et al.]. although major health care reform efforts abruptly halted with the clinton administration's failure to pass meaningful health reform, this movement did usher in a new era of health reform consciousness not seen since the nixon years. as a result, there were modest achievements in health reform with the passage of the health insurance port­ ability and accountability act of 1996, and the creation of the state children's health insurance plan as part of the balanced budget act of 1997. 3. press release, ctr's for medicare and medicaid services, healthcare spending growth rate continues to decline in 2004 (jan. 10, 2006), http://www.cms.hhs.gov/apps!mdia/ press!release.asp?counter= 1750&intnumperpage= 1 o&checkdate=&checkkey--&srchtype=& nudays=3500&srchopt=o&srchdata=&keywordtype=all&chknewstype= 1 %2c+2o/o2c+3%2c +4%2c+5&intpage=&showall=&pyear--&year--&desc=false&cboorder-date (last visited apr. 2008] the recent state rally for health care reform 281 care costs are predicted to increase from $1.6 trillion in 2002 to $3.4 trillion in 2013, consuming 18.4% of the gdp.4 furthermore, the all too familiar statis­ tics continue to indicate that forty-seven million individuals are currently with­ out health insurance in the united states.5 increasingly, those most at risk for uninsurance continue to be the working poor, part-time employees, self­ employed workers, young adults, and those with household incomes of less than 200% the federal poverty limit ("fpl").6 however, one of the fastest growing segments of the uninsured is working low-middle, to middle class in­ dividuals and families with incomes at or below 400% fpl.7 not surprisingly, in the midst of this worsening trend is a growing lack of confidence by consumers that continues to intensify as average insurance pre­ miums consistently rise to levels above the rate of inflation.8 additionally, many uninsured are left in an undertow of debt, stricken with unpaid medical bills which have propelled the skyrocketing number of personal bankruptcy claims.9 with access to affordable care lagging, a growing number of ameri­ cans have become increasingly dismayed with the current state of the entire health care system, and rate the care they receive as fair and in many instances poor. 10 26, 2008). 4. earl dirk hoffman et al., brief summaries of medicare and medicaid: tme xviii and xix of the social security act 5 (2004), available at http://www.cms.hhs.gov/ medicareprogramratesstats/downloads/medicaremedicaidsummaries2004.pdf. 5. carmen denavas-walt, bernadette d. proctor&jessicasmrrn, u.s. census bureau, income, poverty, and health insurance coverage in the united states: 2006, 18 (2007), available at http://www.census.gov/prod/2007pubs/p60-233.pdf. 6. !d. at 20-2. 7. john holahan & allison cook, kaiser comm'n on medicaid & the uninsured, why did the number of uninsured contth.'ue to increase in 2005? 6 (oct. 2006), http://www.kff.org/uninsuredlupload/757l.pdf (noting the largest growing group among those without insurance were those with household incomes over $50,000). 8. abc news/kaiser fam. found./usa today, health care in america 2006 survey (2006), http://www.kff.org/kaiserpolls/upload/7572.pdf [hereinafter abc kaiser survey] (discussing how health care costs rose 7.7% in 2006 or twice the rate of inflation). 9. !d. (revealing increased cost and financial constraint as the main reasons for dissatis­ faction and noting an alarming increase in the number of uninsured delaying care to avoid ac­ cumulating debt). see also michelle m. doty et al., seeing red: americans driven into debt by medical bills, the commonwealth fund, aug. 2005, http://www.cmwf.org/usr_doc/837 _ doty _ seeing_red _medical_ debt. pdf (noting that thirty-seven percent of adults nineteen and old­ er (77 million americans) have trouble paying for medical care and that debt related to health care expenses account for forty to fifty percent of all personal bankruptcies filed). but cf david dranove & michael l. millenson, medical bankruptcy: myth versus fact, 25 health aff. w74, w74w83 (2006) (research indicates the actual number of personal bankruptcies attribut­ able to medical bills is only seventeen percent. most individuals filing bankruptcy are not mid­ dle class, but are instead in low-middle to lower economic classes). 10. ruth helman, mathew greenwald & associates & paul fronstin, 2006 health confi­ dence survey: dissatisfaction with health care system doubles since 1998, ebri notes, nov. 2006, at 2-12, available at http://www.ebri.org/pdfi'notespd:ijebri _notes _11-20061.pdf (noting six in ten americans rate the overall health care system as fair or poor even though fifty­ two percent rate the quality high. see also abc kaiser survey, supra note 8 (reporting six in ten dismayed over quality and costs of the health care system). 282 indiana health law review [vol. 5:277 businesses are also applying political pressure to find economic solutions to the health care problem which is straining their ability to remain competitive in the quickly expanding global economy. in particular, smaller businesses that spur most of the new job growth in the country, especially those with less than 500 employees, are increasingly less likely to provide health insurance coverage to their employees, leaving as many as forty million workers without health care. 11 in 2006, the number of americans with employer-based insurance dropped below sixty percent for the first time. 12 this has led to a trickle down effect where many employee dependents are also left without coverage.13 with increasing numbers of employers dropping health benefits, insurance compa­ nies have not provided alternatives or corrections to the managed care phe­ nomenon which has ultimately failed to control rising costs and expand coverage to workers. 14 2. the fallout from the managed care movement the structural changes that emerged from the managed care era have cre­ ated a system with serious disconnects in the provider continuum. managed care attempts made during the past two decades to transform and integrate the health care delivery system, by introducing a broad array of public and private­ sponsored health plans and programs, focused on cost-containment, utilization and review controls that ultimately restricted provider choice. they have failed in many respects to create the affordable and accessible markets that were envi­ sioned for consumers. 15 while a complete discussion of these past successes and failures is beyond the scope of this note, it can be safely asserted that the resulting effect of managed care has been marked by significant consolidation over the past two decades which has lead to intense competition between doc.­ tors, insurers, and hospitals for market share and managed care contracts. this competition has brought about the formation oflocal and regional health net­ works that have in many instances crowded both providers and consumers out 11. james d. reschovsky, bradley c. strunk & paul ginsberg, why employer-sponsored health insurance coverage changed, 1997-2003, 25 healrnaff. 774, 774-82 (2006) (noting that nine million lost health insurance coverage from 2001-2003 for many reasons including the economic downturn that occurred after september 11,2001, increased costs ofpremiums to employers, and the fact that health care costs grew faster than wages). see also ann hilton fisher, small employers and the health insurance needs of employees with high health care costs: a need for better models, 8 emp. rts. & emp. pol'y j. 53, 55-6 (2004). 12. see denavas-waltet al., supra note 5, at 20. 13. laura d. hermer, private health insurance in the united states: a proposal for a more functional system, 6 hous. j. heal till. & pol'y 2, 19-20 (2005). 14. marmor & oberlander, supra note 1, at 208-209 (2004) (noting hmos were never truly effective at containing health care costs. hmos ultimately played a key role in creating an environment where medical inflation was twice the consumer price index by mid-2002). 15. see generally mark hall, mary anne bobinski & david orentucher, heal til carel. & etiiics, 935-42 (6th ed. 2003) [hereinafter hallet al.]. see also john v. jacobi, dangerous times for medicaid, 33 j.l. med. etiiics 834, 840-41 (2005). 2008] the recent state rally for health care reform 283 of the market. 16 as a result, the new health care paradigm that has emerged no longer recognizes the traditional, top-heavy, physician-led community hospital system, but instead is increasingly giving way to an unforgiving model of effi­ ciency driven by economic and market pressures to contain costs. 17 while this fundamental shift invites many questions about how effectively health care is now being utilized in this new era, two key changes did emerge in redefining how hospital systems currently do business: the large number ofhospital merg­ ers and the emergence of specialty hospitals. with the emergence of aggressive competition between providers, and the increased need to stay relevant and expand their geographic presence in the managed care market, many hospitals have been forced, by thinning margins created by decreased reimbursement rates from third party payers and the fed­ eral government, to join together with former competitors and large physician groups. 18 in addition, specialty physicians caught in the cross-fire of trying to retain economic control of their practice became increasingly unhappy with their managed care relationships with hospitals as the ability to get their fair share of the shrinking reimbursement pie decreased, a trend that eventually led to the emergence of specialty hospitals. 19 the proliferation of specialty hospi­ tals resulted in many lucrative service lines such as cardiac, orthopedic, labora­ tory, and imaging services being stripped from hospital profit centers.20 in response, hospitals have renegotiated financial relationships with physicians, leading to the creation of joint ventures and other collaborative partnerships in an attempt to maintain their revenue targets and position in the marketplace.21 as the health care system has morphed through the various versions of managed care, states have faced rapidly growing costs resulting from the need to pay for state employee health benefits, public health programs such as medi16. see furrow et al., supra note 2, at 535-40 (while the dynamics of the integration that occurred under managed care are complex, the delivery system that emerged often favored hospitals and insurers who had deeper pockets to re-structure the system in their favor to win managed care contracts. as a result there was both "horizontal integration" (physician group mergers, hospital mergers) and "vertical integration" (hospitals and physicians entering into partnerships and affiliations to create "one-stop-shopping" and many instances their own hmo to maximize geographic coverage needed to leverage economic power with employers when selecting their managed care provider. the integration phenomena, however was followed by many bankruptcies of hospitals and hm os who spent too much money to buy physician prac­ tices or failed to manage risks properly). 17. james f. blumstein, the application of antitrust doctrine to the healthcare indus­ try: the interweaving of empirical and normative issues, 31 ind. l. rev. 91, 92-4 (1998)( out­ lining the change in the health care marketplace from a system driven by a pure physician-led professional model to a more open market system where the physician decision-making and utilization patterns are now subject to market forces). 18. halletal.,supra note 15, at 1042-50. 19. furrow et al., supra note 2, at 545-46. 20. financing the future ii report 4: joint ventures with physicians and other partners, healthcarefin. mgmt. ass'n, feb. 2006, at4-10, availableathttp://www.hfma. org!nr/rdonlyres/4cd52880-dc83-469b-a9e6-dl 072a 75c455/0jfnf2 _no_ 4.pdf[hereinaf­ ter financing the future]. 21. furrow et al., supra note 2, at 545-46. 284 indiana health law review [vol. 5:277 caid, and the increased demands that the uninsured have placed on the safety net system including community hospitals and community health centers.22 the increased demand for complex and technologically advanced care for an aging medicaid and medicare population, in a system complicated by a weakened community hospital infrastructure and a shortage of key health providers, has also complicated the ability to provide health coverage. further, for many without coverage, the health care environment has become a high-stakes health care poker game where many uninsured consumers put off obtaining necessary health services until it becomes a critical necessity. the result is an unhealthier population where basic health care needs are not being met.23 and when the uninsured finally do seek health services, the fmancially strapped emergency rooms of safety net hospitals and community health centers ("chc") often be­ come the default primary care providers. 24 many safety net hospital systems that are disproportionately caring for the uninsured are sustaining fmancial losses that threaten their existence. with safety net systems on the ropes, other nonprofit and for-profit hospitals are not only shifting more resources to care for the uninsured, but also worrying about their fate as the health care crisis unravels. 25 faced with one of the most important modem political and economic challenges, states have determined the status quo is unacceptable and are chal­ lenging what is quickly becoming an outdated health care system entangled with an employer-based insurance model that is no longer working effectively. complicating this phenomenon is the increased consumer demand for the latest 22. bruce c. vladeck, payingfor hospitals' community service, 25 healmaff. 34, 3443 (2006) (hospitals in the country spend approximately $30 billion on uncompensated care which inevitably gets cost-shifted to the insured (through increased premiums and co-pays) where there is a smaller pool of individuals able to cover actual costs incurred by hospitals. general hospitals operating are having trouble maintaining their mission to provide health pro­ fessional training, and provide care for their community, especially in rural and underserved urban areas). see also michael k. gusmano et al., exploring the limits of the safety net: community health centers and care for the uninsured, 21 healmaff. 188, 188-94 (2006) (chcs serve an important role in the "patchwork" system that provides basic health services to the uninsured, but chcs are now under increasing stress to provide additional services such as specialty care and advanced diagnostics. chcs should be given more funding to expand care and services to the uninsured as they already play a vital role in the health care delivery system in many underserved communities). 23. bruce siegel, marsha regenstein & peter shin, health reform and the safety net: big opportunities; major risks, 32 j.l. med. & ennes 426, 428 (2004) (noting the uninsured receive less preventive health care, leading to an increased likelihood of advanced chronic dis­ ease relative to the insured population). 24. id. at 426-27. 25. id. at 427-28 (discussing that safety net hospitals are under increasing pressure to rethink their business strategy, and in many cases, face closure due to the increasing demands placed upon their hospital, the uninsured and shrinking reimbursement). but cf jack e. karns, justifying the nonprofit hospital tax exemption in a competitive market environment, widener l. rev. 383, 415-25 (2004) (discussing many non-profit hospitals actually benefit from providing a certain amount of non-reimbursable care to the uninsured by protecting the hospital's nonprofit status, thereby avoiding taxation). 2008] therecentstaterallyforhealthcarereform 285 and most advanced health care technology available, a demand that often fails to consider how payment for the services is to be provided. as states realized that substantive federal action was not available to help solve these complex issues, they have taken the driver's seat to prevent their problems from skidding further out of control. whether states will get the federal help they need to con­ tinue reform efforts remains to be seen, but voters during the current 2008 pres­ idential election have once again made the issue of national health care reform into a red-hot topic. voters are showing renewed interest in domestic issues and are clamoring for attention to concerns beyond the war in iraq. specifi­ cally, health care reform ranks as a very important issue that voters want ad­ dressed by their government leaders. 26 b. the federal government's response to rising health care costs so where is the federal government leadership in this crisis today? many would suggest the federal government lost its appetite for health care reform after previous administrations, as demonstrated under president clinton, ulti­ mately failed to provide a palatable, user-friendly approach to health care re­ form. 27 the current administration, under president bush has done little during its time in office to seriously address the issue of expanding health coverage to all americans. instead, as president bush again noted in both the 2007 and 2008 state of the union addresses, the president has continued to push a strat­ egy for health care reform focused on consumer choice that hinges on tax cred­ its for citizens, increased use ofhsas, and the utilization of association plans for employers.z8 on capitol hill, there have been few initiatives worth noting that have addressed the universal health coverage issue. only one legislative effort has addressed universal coverage head-on. representative john conyers introduced house bill676 on february 8, 2005, which proposed a nationalized health plan run under a federally coordinated single-payer system. seventy­ seven co-sponsors have signed on in support, but the bill has failed to gain suf­ ficient traction to move forward.z9 it should be noted, however, that there are several federal legislative efforts that have ultimately informed the reform dis­ cussion since the clinton reform movement. although an analysis of every leg­ islative action, and its effect on the health care system, is beyond the scope of 26. kaiser health tracking poll: election 2008, http://www.kff.org/kaiserpollsl h08 _pomr030708pkg.cfm (last visited apr. 20, 2008) (noting that health care consistently ranks among democrats, republicans, and independents as the most important voter issue behind the iraq war and the economy). 27. marmor & oberlander, supra note i, at 211-13 (recounting president clinton's in­ ability to muster support from congress and popular support from u.s. citizens who saw clin­ ton's plan as another inappropriate expansion of"big government"). 28. the whitehouse, strengthening health care, http://www.whitehouse.gov/infocus/ healthcare (last visited apr. 20, 2008). 29. united states national health insurance act, h.r. res. 676, 109th cong. 1st sess. (2005). 286 indiana health law review [vol 5:277 this note, the enactment of the medicare prescription drug improvement and modernization act of 2003 ("mma"), deficit reduction act of 2005 ("dra"), and the creation of state children's health insurance program ("schip") were all federal legislative strategies that have impacted the health care system and health reform efforts in some manner.30 1. medicare modernization act: the beginning of something good? the medicare modernization act was passed under heavy scrutiny in 2003.31 the mma was most notable for redefining drug benefits for medicare recipients and expanding the use of health savings accounts ("hsa") that ef­ fectively solidified the new era of"consumer-driven health care" ("cdhc"). 32 most contentious was the restructuring of the "part d" prescription benefits for medicare recipients which created a new payment and insurance restructuring that was designed to help subsidize the medications costs associated with the drug entitlement. essentially, part d now requires medicare enrollees to pay a deductible and monthly payment or portion of all drug costs up to $2250, with a "donut hole" provision that then requires beneficiaries to pay up to $3600 out of pocket for medications before coverage kicks in again. 33 the part d restruc­ turing has met with mixed results.34 while overall drug coverage has increased to seniors, out-of-pocket costs have increased as well. the government, how­ ever, has realized cost-savings with the new part d implementation. indeed, it is now predicted that the new part d programs that emanated from the mma are likely to save $113 billion dollars over the next ten years. 35 30. medicare prescription drug, improvement and modernization act of2003, pub. l. no. 108-173, § 1201, 117 stat. 2066,2071 (2003); deficit reduction actof2005 (pub. l. 109171, 120 stat. 4) (2006); balanced budget act of 1997, pub. l. 105-33, 111 stat. 251, (codified as amended 42 u.s.c.a. §§ 1397aa (1997). 31. during the passage of the mma, there were several discrepancies over what the pro­ gram would actually cost and evidence later arose that indicated the bush administration misrep­ resented the total costs in order get the bill past fiscally-minded republicans. in addition, the mma prevents the government from negotiating discounts with the drug companies and pre­ vents the federal government from establishing a national formulary both of which could reduce costs. 32. timothy s. jost & mark a. hall, the role of state regulation on consumer-driven health care, 31 am. j.l. & med. 395, 396 (2005) (defining consumer driven health care as a general understanding that too many americans are "generously" insured and therefore need to incur more ofthe financial burden of paying for care, which will in tum help drive down over­ utilization of health care services). see also medicare prescription drug, improvement and modernization act of2003, pub. l. no. i 08-173, § 1201, 117 stat. 2066, 2071 (2003). 33. lori buchsbaum et al., kaiser comm'n on medicaid & the uninsured, perspec­ tives on medicare part d and dual eligibles: key informants' views from three states, avail­ able at http://www.kff.org/medicaid/upload/7639.pdf. 34. commonwealth fund, study finds medicare's drug benefit substantially increased coverage among seniors, but some continue to be vulnerable to high costs, august 21,2007, http://www.commonwealthfund.org/newsroom/newsroom show.htm?doc id=516616 (last visited apr. 20, 2008). 35. press release; centers for medicare and medicaid services, medicare drug plans 2008] the recent state rally for health care reform 287 with respect to hsas, although stronger incentives were provided under the mma to increase hsa use, many experts question whether the new wave ofcdhc that has followed in an attempt to correct escalating costs will have the predicted net effect of decreasing health care utilization or creating a broad economic benefit for all socioeconomic classes. 36 critics of the president's plan cite that the hsa changes will help the more well-off, and will only bene­ fit three to five million of the uninsured, leaving the bulk of citizens without insurance and with no other way to obtain reasonable coverage.37 (hsas and high deductible health plans are discussed in more detail below under section iv). the mma also authorized the citizens' health care working group which was comprised of various health care experts and citizens who were asked to examine the current health care crisis and make recommendations to improve health care access and quality. the final report, published september 26, 2006, validated a list of recurring themes that emerged from town hall meet­ ings with citizens and discussions with industry experts but did not clearly ad­ vocate any specific reform or plan. 38 six general themes were identified as key health reform benchmarks: 1) establishing a public policy that all americans have affordable health care; 2) guaranteeing fmancial protection against very high health care costs; 3) fostering innovative integrated community health networks; 4) defining the core benefits and services that will be assured to all americans; 5) promoting efforts to improve quality of care and efficiency; and 6) restructuring end-of-life care so that people of all ages have increased access to needed services in the environment they choose. 39 this report has not ap­ peared to have much impact on national health care reform efforts or inspired action under the bush administration. it is worth noting, however, that the group did recommend the federal government provide affordable coverage for all americans by 2012.40 strong and growing (jan. 30, 2007). 36. hermer, supra note 13, at 4-5. see also catherine hoffinan & jennifer tolbert, health savings accounts and high deductible plans: are they an option for low-income fam­ ilies?, henry j. kaiser f am. found., kaiser comm'n on medicaid & the uninsured, oct. 2006, http://www.kff.org/uninsured/upload/7568.pdf (revealing that the income levels of low income families do not favorably match with the economics ofhsas, making hsas an infeasi­ ble method for containing health care costs across the economic spectrum). 37. see amanda gardner, bush's health care proposal inadequate: critics, healrn day news, jan 24, 2007, http://www. washingtonpost.com/wp-dyn/content/article/2007/0 11 24/ar2007012400922.html (last visited apr. 20, 2008). 38. citizens' healtii care working group, healrn care that works for all americans, (2006), http://www.citizenshealthcare.gov/recommendations/finalrecommenda tions _print. pdf. 39. /d. at5. 40. id. 288 indiana health law review [vol. 5:277 2. deficit reduction act the dra was passed in 2005 and signed into law by president bush in 2006 as a measure to control the federal government's entitlement spending.41 the dra laid out a cost savings plan of $26.3 billion, which encompassed a broad array of programs including medicare and medicaid, to be realized over a period of time from 2006-2015. although many believe the dra will have a deleterious effect on the provision of some community services, some contend that the dra has created a new opportunity for some states by promoting sig­ nificant changes in funding for modernization efforts. such funding has al­ lowed more flexibility for states administering their medicaid programs.42 with respect to modernization, the dra has provided $150 million in "transforma­ tion grants," grants which have been used to support state efforts ranging from technology upgrades for chronic disease management programs to technology­ focused strategies to improve the quality of care.43 further, under the dra states have been given increased authority with respect to 1115 demonstration waivers to increase expansion of medicaid by allowing higher-income indi­ viduals to participate. several states have taken advantage of this new dra provision and have gone on to integrate high-deductible plans to increase cost­ sharing with enrollees as a means to increase coverage. but while the dra provides, it also takes away. the new dra provisions also tightened the re­ quirement for providing proof of citizenship to receive access to federal enti­ tlements. 44 this new requirement has been linked to decreased medicaid enrollment and acceptance rates across many states and, as a result, has been challenged in court.45 while the dra provisions have "slowed" the growth of medicaid and other entitlement application rates, it appears that in the end it may be in part a self-defeating measure as some individuals who would have otherwise legitimately qualified will be left uninsured. 3. state children's health insurance program the state children's health insurance program ("schip") was authorized by congress as part of the balanced budget act of 1997 as a joint federal and state funded program administered by the states which has since cost about for41. deficit reduction act of2005, pub. l. 109-171, 120 stat. 4 (2006). 42. id. at§ 6081. · 43. ld. see also cms, medicaid transformation grants, http://www.cms.hhs.gov/ med icaidtransgrants (last visited apr. 20, 2008). 44. see deficit reduction act § 6036. 45. bell v. leavitt, no. 06 c 3520, 2007 wl 551553 (n.d. ill. feb 16, 2007). the court denied the class action challenge as the plaintiffs failed to properly articulate a constitutionally or legally viable challenge to the dra statute. as a result of this case, however, the bush ad­ ministration later exempted over 8 million supplemental security income and medicare benefi­ ciaries as well as a number of children receiving benefits via adoption or foster care assistance programs. 2008] the recent state rally for health care reform 289 ty billion dollars. 46 the purpose for enacting the schip program was to reduce the number oflow-income uninsured children in the united statesespecially among those families who exceed eligibility for medicaid benefits. schip is not an entitlement program but is rather a state-run program that provides fixed funding for limited benefits to qualified enrollees. each state may design its own program, but must follow pre-determined federal guidelines when outlin­ ing parameters such as eligibility, payment levels for coverage, and administra­ tive and operating procedures.47 generally, schip funding is targeted to cover uninsured children whose families have income that exceeds medicaid eligibil­ ity, but are at or below the 200% fpl. fourteen states have waivers which al­ low for coverage of some adults, parents and caretakers of schip-eligible children, pregnant women, and childless adults. forty-one states have chosen to cover children in families at 200% the fpl or higher with seven states pro­ viding coverage up to 300% fpl.48 under current law, states are prohibited from providing schip benefits to illegal immigrants who have been in the u.s. less than five years, undocumented children, children of the state and public employees, children over age eighteen, and/or children who already have pri­ vate coverage. in its first year, schip enrolled 897,000 children rising to 4.1 million children enrolled in the united states as of june 2006. since schip's incep­ tion ten years ago, as many as six million enrollees have been covered, includ­ ing 639,000 adults.49 however, nine million children who are eligible for schip funding remain uncovered in the united states. some states have seen decreases in schip coverage. but the overwhelming majority of states have been increasing coverage as result of the loss of employer-sponsored insurance and the increase in the number of parents who were once on medicaid, are no longer eligible, and now qualify for schip. in july 2007, both houses of congress passed the re-authorization of the schip program which went to the president for approval. in the negotiations that lead up to the final vote, the president proposed a five billion dollar in­ crease in funding whereas the house proposed a fifty billion dollar increase, and the senate a thirty-five billion dollar increase.50 in order to pay for the 46. balanced budget act of 1997, pub. l. 105-33, 111 stat. 251, (codified as amended 42 u.s.c.a. §§ 1397aa (1997) (tnle xxi-state children's health insurance program). the centers for medicare and medicaid services ("cms") and department for health and human services ("dhhs") have federal oversight for all state medicaid and schip programs. 4 7. gao highlights, states' schip enrollment and spending experiences and consid­ erations for reauthorization, feb. 15, 2007, available at http://www.gao.gov/new.items/ d0750 1 t.pdf; see also george washington university center for health services research and policy, policy brief#6, from schip benefit design to individual coverage decisions, http://www.gwurnc.edu/sphhs!healthpolicy/chsrp/downloads/schip _ brief6.pdf. 48. kaiser comm'n on medicaid & the uninsured, schip turns l 0: an update on enrollment and the outlook on reauthorization from the program's directors, (may 2007), available at http://www.kff.org/medicaidlupload/7642.pdf. 49. ld. at 6. 50. kaiser comm'n on medicafd & the uninsured, scrip: reauthorization 290 indiana health law review [vol. 5:277 schip expansion congress considered a federal cigarette tax of up to ¢.61. in the end, no compromise could be reached, and the president vetoed the bill. the president issued the veto stating many ofhis constituents were against any major funding increases for schip because it would have the effect of creating an incentive for some parents to opt out of employer coverage to qualify for schip; thereby, causing schip to insure middle-income children that the pro­ gram was never designed to cover. much of the controversy over schip stemmed from the increase in family income that would have increased eligibil­ ity to families at 300% fpl or $63,000 for a family of four. 51 those in favor of the schip re-authorization, fearing a failure tore-up the program would further worsen the uninsured problem, felt that the expansion was critical to getting health care services to more children. 52 some see schip as a good faith effort to cover children while others worry that schip represents a major step to­ wards a single-payer federally funded mandate for universal health care. the schip debate will likely heat up again, perhaps even in the context of health reform, but the next debate will come under a new president as president bush signed an extension which will fund schip through march, 2009. iii. states with promising universal health care reform lnitiatives a. major movers in state health care reform over twenty states have recently offered innovative answers to the finan­ cially and morally perplexing issue of health care consumption and the unin­ sured. 53 with the average state spending twenty-two percent of its budget on medicaid costs alone, states are no longer idly standing by to watch their budg­ ets fall under the weight of continued uncontrollable health care costs. 54 as each state moves forward with unique health reform programs to meet their specific geographic and socioeconomic requirements, various elements are be­ ginning to emerge that may be applicable in the future reform efforts of every state. for purposes of this discussion, the promising aspects of three comprehistory, (jan. 2008), available at http://www.kff.orglmedicaidlupload/7743.pdf. 51. martin k».dy, house fails to muster schip veto override, poltico.com, oct. 18, 2007, http://www.politico.com/news/stories/1007/6438.html (last visited apr. 20, 2008). 52. mary e. rimsza, richard j. butler, & william g. johnson, impact of medicaid disen­ rollment of health care use and costs, 119 pediatrics 5, e1 026-32 (may 2007). the authors conducted a retrospective review of the utilization records of thousands of children who were en­ rolled in arizona's medicaid/schlp program. the team showed that a ten percent reduction in enrollment led to an increase in costs of$2121 yearly for each disenrolled child caused by expenses related to substantial increases in emergency utilization and in-hospitals stays. 53. nat'lconferenceofstatelegislatures,heal1hreformbills,http://www.ncsl. orglprogramslhealth/universalhealth2007.htm (last visited apr. 20, 2008). 54. nat'lgovernorsassociationand1henationalassociationofstatebudget officers, the fiscal survey of states (2007), http://www.nasbo.org/publications/pdfs/ fiscal%20survey"/o20ofl/o20the%20states%20june%202007.pdf. 2008] the recent state rally for health care reform 291 hensive state plans, massachusetts, maine, and vermont will be discussed in greater detail. in addition, compelling aspects of other emerging plans will be examined with regard to innovative ideas that may provide insight into strate­ gies that could be adopted by other states or as part of a national reform effort. 1. massachusetts-commonwealth care massachusetts has been in the process of rolling out its new universal health care plan, "commonwealth care," to cover its 600,000 uninsured citi­ zens. this plan is one of the first comprehensive plans in the country that is dedicated to a universal health model. the bipartisan plan was passed in march 2006 and signed into law by then governor mitt romney on april 12, 2006.55 the massachusetts plan uniquely mandates participation for all citizens and employers. 56 those individuals who fail to enroll can lose their personal state income tax deduction and face additional fines of up to fifty percent of the low­ est priced insurance that can be afforded. 57 employers with more than ten em­ ployees who fail to provide insurance coverage are required to contribute a "fair share" yearly payment of$295 per employee. 58 the fair share payment paid by employers is allocated to the general commonwealth fund to cover the unin­ sured. in addition, employers will be required to set up section 125 cafeteria plans that will allow employees to purchase health care insurance in the new plan with pre-tax income. 59 massachusetts has utilized a quasi-governmental entity, the common­ wealth care insurance connector ("connector"), which has functioned as the central administrating agency linking individuals and employers to six insur­ ance products subsidized by the state. the plans were selected based on their ability to provide comparable services similar to what would be purchased on the open market and are portable upon a change in employment. subsidized coverage is provided for an individual or family with an income up to 300% fpl. 60 individuals can purchase subsidized insurance that will require payment of a monthly premium based on an income sliding-scale in addition to a stan55. see 2006 mass. acts ch. 58. 56. !d. 57. jeffrey krasner, sign-up push is on for health coverage: sweeping state law gets a major test, boston.com, dec. 29, 2006, available at http://www.boston.com/newsllocav massachusetts/articles/2006/12/29/sign _up _push _is_ on _for_ health_ coverage/ (last visited apr. 20, 2008). 58. beth waldman, massachusetts health care reform: using an 1115 waiver to provider private insurance to contain costs (2006), http://www.nhpf.org/handouts/ waldman. slides_ 05-16-06.pdf. 59. id. section 125 cafeteria plans are authorized under the internal revenue code which provides employers the ability to allow employees to purchase health insurance with pre­ tax dollars; see faqs for government entities regarding cafeteria plans, http://www. irs.gov/govt/fslg/article/o,id=112720,00.html#1 (last visited apr. 20, 2008). 60. kaiser comm'n on medicaid & the uninsured, massachusetts health care reform plan: an update (2007), http://www.kff.org/uninsured/upload/7494-02.pdf. 292 indiana health law review [vol. 5:277 dard co-payment for office visits and hospital stays. 61 individuals with less than 100% fpl will not be required to pay premiums. the health plans cover many inpatient and outpatient services including coverage for inpatient and outpatient care, mental health and substance abuse treatment, vision care, dental care, hospice care, emergency care, and certain rehabilitation services.62 massachusetts' plan was predicted to cost $1.2 billion over a three-year period. funding for the plan was initially paid for by a complex scheme involv­ ing medicaid expansion to cover children, a medicaid 1115 waiver, and the mandate payment schedule previously described.63 as of april, 2008, the commonwealth plan had enrolled 174,000 individuals but reported a budget shortfall of$153 million. 64 for the upcoming fiscal year, 2008-2009, governor deval patrick has requested $869 million to fund the commonwealth care pro­ gram, up from $472 million budgeted the previous year. since the inception of the program about 340,000 of the uninsured have acquired insurance either through the connector or as required under the mandate. in addition, the dol­ lars that were previously allotted to safety net hospitals for providing increased uncompensated care have been reallocated to a health safety net trust fund, which has paid safety net providers out of a combined fund of medicaid and disproportionate share fund dollars ("dsh"). as more people enroll in the new plan and as uncompensated care decreases, the money in the safety net trust fund will be shifted to the commonwealth subsidy plan to expand coverage to the uninsured pool. 65 the innovative massachusetts plan has many stakeholders and policy­ makers around the country looking closely at the various parts of the package, especially the connector. although it is not clear if the uninsured will com­ pletely benefit from the plan, the connector does provide options for many who might otherwise not be able to secure coverage. the connector's strengths lies in the fact that it creates a centralized structure that combines a unique utiliza­ tion of insurance products and premium subsidies through an exchange that provides consumers and employers affordable insurance options that can be used to expand coverage and provide portability. while it appears future fund­ ing and cost control will be an on-going issue, the commonwealth plan is in front, leading the reform charge with the passage of this bold program. 61. jd. 62. commonwealth care commonly asked questions, http://www.mass.gov/ eeohhs2/docs/masshealth/memlibrary/commonwealthcare-faqs-eng.pd£ 63. ld. see also 2006 mass. acts ch. 58. 64. kevin sack, universal health care to cost massachusetts more than was budg­ eted, nytimes.com, apr. 17, 2008, available at http://www.nytimes.com/2008/04/17/us/ 17brfs-universalhea _ brf.html (last visited apr. 20, 2008). 65. waldman, supra note 58. 2008] the recent state rally for health care reform 293 2. maine-dirigo health although it was launched to less fanfare than the massachusetts plan, in june 2003, maine was one of the first states to respond to rising health care costs and the lack of health insurance coverage with the passage of the dirigo health reform act. 66 the voluntary plan is an incremental approach intended to cover the 130,000 uninsured in the state by 2009.67 the dirigo health agency was created to work in conjunction with the state bureau of insurance and department of health and human services to provide collaboration and oversight for the subsidized health plan. key components of the legislation included the passing of several progressive cost-reducing measures and the cre­ ation of a state-sponsored health plan administered by a private insurer. 68 cost containment measures highlighted in the plan included: strengthening certifi­ cate-of-need program oversight, reducing bad debt and charity care, increasing transparency in pricing to promote an understanding of the actual costs of care, improving medical malpractice insurance review, limiting needless capital in­ vestment by the health care community, capping hospital margins at roughly three percent, promoting the use of underused facilities around the state for non-emergency, outpatient procedures, and placing limitations on insurance premium growth.69 the maine plan was financially supported by individual and employer contributions, an upfront payment by the state of fifty-three mil­ lion dollars, and is sustained through the use of a unique and controversial sav­ ings offset payment ("sop"). the sop is based on a complex factorial analysis that is itself based on an aggregate measurable savings largely determined by the revenue reduction spent on uncompensated care. 70 essentially this offset adds a two percent surcharge to all health care insurance gross premium reve­ nues that exceed four percent. 71 • central to the dirigo health plan was the creation of a public-private ven­ ture providing health coverage plans administered by a private insurer, which offers both low and high deductible plans focused on high-quality, preventive care. 72 the plan is an option for employers with less than fifty employees, as well as those who are self-employed, or individuals up to 200% fpl. employ66. an act to provide health insurance to small businesses and individuals to control health care costs, me. rev. stat. ann, tit. 24-a, § 6901-6971 (2003). see also maine.gov., http://www.dirigohealth.maine.gov/dhspold.html (last visited apr. 20, 2008). 67. see maine.gov ., dirigo health http://www.dirigohealth.maine.gov/ (last visited apr. 20,2008). 68. jd. 69. see maine.gov, http://www.dirigohealth.maine.gov/dhlp04.html (last visited apr. 20, 2008). 70. see savings offset payment q &a, http://www.dirigohealth.com/sopqa_ revised.pdf(providing a detailed discussion of the offset plan). 71. me. rev. stat. ann, tit. 24-a, § 6901-6971 (2003). see also maine.gov.,http:// www.dirigohealth.maine.gov/dhspold.html#savingsoffset (last visited apr. 20, 2008). 72. see maine.gov, dirigo partners with nonprofit, sept. 2007, http://www.dirigo health.maine.gov/dhlp07.html (last visited apr. 20, 2008). 294 indiana health law review [vol. 5:277 ers are required to pay a portion of the monthly premium for their employees (up to sixty percent of the premium) whereas self-employed individuals and those without insurance pay a premium based on a household income sliding­ scale. the maine program has only enrolled about 28,000 individuals in 2007 and has been met with several challenges. the sop noted above sustained a court challenge in which the surcharge was upheld as lawful. 73 also, as the dirigo choice program has been a voluntary program, maine citizens have been slow to sign up. small businesses and individuals have complained that the costs remain too high and that the use of a single insurer has limited options especially in rural parts of the state. although governor baldacci was able to sign legislation requiring maine's program to self-insure in an effort to promote individual and small business coverage, other initiatives were left on the table for future consideration. the legislature remains interested in passing the fol­ lowing measures: a conversion of sop to a surcharge on hospital bills, funding for increased primary care services, increased incentives for individuals who choose healthy lifestyle choices, enhancement of care quality measures, and a premium tax on insurers to fund new coverage. 3. vermont-catamount health in may 2006, vermont legislators and governor jim douglas enacted a voluntary universal plan to control rising costs and help cover 69,000 uninsured citizens. 74 the catamount health plan provides vermont residents who are at or below 300% fpl, the opportunity to purchase subsidized insurance provided by two commercial insurance companies. 75 in addition to the catamount health option, the plan also provides sliding-scale subsidies for those who are employed, or where the employer offers no coverage or limited coverage for either hospital or doctors services. to qualify for subsidies to the employer­ sponsored insurance, the individual must have an annual household income at or below 300% fpl.76 for those who have no insurance, and who are over 300% fpl, they can participate in the plan and must pay premiums based on a sliding-scale of household income. in order to be eligible for one of the plans, an individual must have been without health insurance for twelve months. oth­ er incentives require the benefits offered by the catamount plan to be aligned 73. see maine ass'n ofhealth plans v. superintendent oflns., 923 a.2d 918 (me. 2007); see also http://www.dirigohealth.com/opp_meahp_mot3_dha.pdf (the maine court system again denied the maine health association a third challenge to the validity of the sop for 2008). 74. 2006 vt. acts & resolves 191, an act relating to health care affordability for vermonters. see also 2006 vt. acts & resolves 190, an act relating to catamount health. 75. id. see also health care reform legislation, http://hcr.vermont.gov/health_care_ reform_legislation (last visited apr. 26, 2008). 76. 2006 health care reform initiatives, http://www.leg.state.vt.us/healthcare/2006_ health_ care_ constituent_ information_ sheet.htm (last visited apr. 20, 2008). 2008] the recent state rally for health care reform 295 or on par with similar health insurance plans offered in the open market. at minimum, the plans must cover primary care treatment, immunizations, care for chronic health conditions, and hospital services. although there is a deductible for hospital services, there is no deductible requirement for primary care ser­ vices or care related to chronic health conditions. the vermont plan is funded by a combination of an 1115 waiver and a progressive tax on tobacco products, including an ¢.80 per pack cigarette tax.77 employers, who do not provide insurance coverage for employees, must pay a $365 yearly surcharge per employee not covered. 78 participation in the program is voluntary, but if ninety-six percent of all vermont citizens are not enrolled by 2010, the legislature will consider a mandate requiring all vermonters to enroll. last year, centers for medicare and medicaid ("cms") agreed to provide federal support for premium assistance up to 200% fpl which will help the state expand coverage. other key aspects of the plan include the following: incen­ tives to decrease insurance rates for those who participate in wellness programs, a new program to provide loan relief to attract health care providers to the state, additional programs to increase quality hospital care by minimizing medical errors, and incentives to increase the use of advanced directives to encourage organ donation. vermont's plan also provides for a regular review of health care cost reductions that will in turn be passed on in savings to vermont citi­ zens who participate in traditional employer-based insurance plans. since oc­ tober 2007, the vermont plan has enrolled over 700 individuals. b. other promising state initiatives there are other health reform initiatives that have made their way to state legislatures around the country.79 while an exhaustive list of all initiatives is beyond the scope of this note, the more promising aspects of comprehensive state initiatives are presented for discussion here. 80 1. california california has been locked in a health reform battle that continues to rage. while california's plan has had several setbacks since governor schwar­ zenegger' s reform announcement in january 2007, the california effort remains one ofthe more intriguing proposals on the table, given the totality of the pack­ age proposed and the fact that 6.8 million individuals are uninsured in the state. 77. id. 78. !d. 79. see nat'lconf. of state legislatures, health reform bills, http://www.ncsl. orglprograms/health/universalhealth2007.htm (last visited apr. 20, 2008). 80. id. within the next year, the states of washington, oregon, illinois, wisconsin, south dakota, iowa, connecticut, kansas, minnesota, new york, and virginia will debate ma­ jor reforms proposals within their respective legislatures. 296 indiana health law review [vol. 5:277 unfortunately, the recent proposal, the health care security and reduction act, was killed in senate committee as it was deemed too expensive.81 califor­ nia's proposal is worth discussing, however, because the passage would cer­ tainly raise the stature of the health reform debate as it would represent the largest expansion of health care coverage since the enactment of the federal medicare and medicaid programs. the plans currently under consideration would cover 3.6 to 5.1 million ofthe uninsured including most children.82 under the most recent legislative proposal, an individual mandate would be instituted. individuals with incomes under 250% fpl, whose premiums exceed five percent of their income, would be exempt from the mandate. chil­ dren up to 300% fpl would be eligible for any subsidies offered by the state. for those with incomes less than 250% fpl, the state would subsidize cover­ age, and for those under 150% fpl no premiums would be charged. workers at 250-400% fpl, who would not otherwise qualify for subsidized coverage, and whose premiums exceed five percent offamily income, would receive a tax credit to help offset costs. the california program's proposed financing in­ cludes a variety of sources including: an employer contribution of 16.5% for employees not covered (based on the size of the overall payroll); county gov­ ernments would be expected to contribute up to $1 billion to cover costs; to­ bacco taxes would be raised up to $1.7 5 per pack; and hospitals would pay four percent of revenue to a state-controlled fund. in addition, it is estimated four billion dollars in federal medicaid funds will be needed to cover the plan. 83 the state plan also calls for additional features including: 1) use of section 125 cafeteria plans and the use of health savings accounts by employers; 2) a goal of 100% connectivity for electronic health data in ten years; 3) designation of the "managed risk medical insurance board," that would determine coverage and advise on other health-related program matters; 4) impose an 85% medical loss on health plans; and 5) would require health insurance carriers and plans to guarantee coverage for anyone who is under the mandate even with a pre­ existing condition. in the end, a senate committee financial analysis found that the forecasted premium of $250 (based on the state's $18 7 medicaid premium) would instead cost $300 causing a $3.9 billion dollar shortfall versus the $2.7 billion surplus projected by 2015.84 given the fact that california is facing a $14.5 billion budget deficit by 2009, it's not surprising that the measure died in committee. even so, the sponsors and governor schwarzenegger remain committed to reel81. see doug trapp, health system reform stumbles in california, amednews.com, february 18, 2008, http:/ /www.ama-assn.org/amednews/2008/02/18/gvsa0218.htm (last visited apr. 20, 2008). 82. faq about abx1 1 (nunez and perata), http://calhealthreform.org/content/view/63 (last visited apr. 20, 2008). 83. health care security and cost reduction act, a.b. no. 1 (1st ex. sess.) (ca. 2007). 84. see trapp, supra note 81. 2008] the recent state rally for health care reform 297 ing in california's rising health costs and getting a health reform package passed. 2. maryland the maryland legislature passed the maryland fair share health care fund act (the "act") in 2006.85 maryland has the highest per capita income in the country and a lower than average number of uninsured residents, numbering 97,000.86 although the act was passed in the legislature, it was not enacted. 87 maryland's statute, by intentional design, was drafted to require large employ­ ers to pay for insurance for their employees with the hope of expanding cover­ age to many of the working uninsured. the outcome was that one large company, wal-mart, was ultimately singled-out to provide coverage for their employees. what has become known as the "wal-mart law," required that all non-governmental employers with 10,000 or more employees provide health care coverage. 88 the act required that for-profit employers spend an amount equal to at least eight percent of the total wages paid to its maryland employees on health insurance costs for those employees. when a covered employer failed to spend the required amount on health insurance, the act obligated the employer to pay to the maryland fair share health care fund (the "fund") the difference be­ tween the employer's actual health insurance outlays and the employer's statu­ torily mandated health insurance payments. the fund, in tum, would be used to finance maryland's medicaid program for low-income residents. further, the act did not allow employers to deduct from their taxes the required pay­ ments for their employee's wages. on november 19, 2007, maryland moved forward with other health reform initiatives under the working families and small business health cov­ erage act ("maryland act") that is predicted to cover l 00,000 of the unin­ sured.89 the maryland act is funded through various mechanisms which include: general funds, lottery revenue, money shifted from the state's high-risk pool fund, and hospital uncompensated care savings. the maryland act offers subsidies to small employers with two to nine employees if the employer incor­ porates a wellness plan and allows for section 125 cafeteria plans. other as85. md. code. ann., lab. & empl. § 8.5-101 (2007). 86. thomas r. oliver, holding back the tide: policies to preserve and reconstruct health care insurance coverage in maryland, 29 j. healni pol'y & l. 203,204-05 (2004). 87. md. code. ann., lab. & empl. § 8.5-101 (2007) (maryland house bill97 intro­ duced jan. 12, 2006). 88. edward a. zelinsky, maryland's "wal-mart" act: policy and preemption, 28 cardozo l. rev. 84 7, 848-50 (2006) (outlining the statute provisions eventually struck down under erisa preemption); see also retail indus. leaders v. fielder, 475 f.3d 180 (4th cir. 2007) (upholding the trial court determination of the erisa preemption). 89. working families and small business health coverage act, s.b. 6, 2007leg., 424th sess., 1st spec. sess., (md. 2007). 298 indiana health law review [vol. 5:277 pects of the maryland act included: increasing the age by which dependents could be covered to age twenty-five; establishing the health quality and cost council; increasing funding for it initiatives and; providing an expansion of medicaid eligibility of up to 116% fpl for poor adults who are parents or indi­ viduals who serve as the primary caretaker for a dependent child living at home.90 3. pennsylvania governor ed rendell put forth the "cover all pennsylvanians" plan ("cap") in 2007 to focus on providing coverage options for small businesses and the 767,000 citizens who are uninsured.91 already, pennsylvania passed the "cover all kids" program in 2006 receiving additional federal funding to subsidize premiums for children living in families below 300% fpl. currently the pennsylvania legislature is close to passing the "pennsylvania access to basic care," ("p aabc") initiative which would increase coverage to the unin­ sured and would help pay for physician medical malpractice coverage. 92 the paabc closely follows governor rendell's larger cap plan introduced last year. if passed, the p aabc will likely be provided through various private market insurance products. individuals who earn less then 300% fpl would receive subsidies based on income to pay for monthly premiums which range from forty dollars per month for those at 150-175% fpl, to fifty dollars per month for those within 175-200% fpl. those at 200300% fpl will be re­ sponsible to pay the full amount minus an employer contribution which is pre­ dicted to be about $280 per month. businesses with fewer than fifty employees who have employees that earn less the state's annual wage would qualify. businesses qualification would also be required to enroll at least seventy-five percent of all employees and pay up to fifty percent of the employees' premium. the cost would vary but is predicted to not be more than $130 per worker, per month. the plan would be paid for through increased federal funds, a "fair share" contribution by non-participating employers, and an increased cigarette tax. 90. see sb6summary of working families and small business heal til coverage act, available at http://mlis.state.md.us/other/fiscal_ briefings _and_ reports/2007 _summary_ sb6.pdf. 91. see rx for pennsylvania, http://www.rxforpa.com/ (last visited apr. 20, 2008) (the site provides an overview of governor rendell's plan). 92. pennsylvania access to basic care, s.b. 1137, gen. assem., reg. sess. (pa. 2007). the pennsylvania plan offers the following: provides more than 270,000 uninsured working pennsylvanians access to basic health care; makes $42 million available for grants to small busi­ ness employers who are already providing health-care coverage to their employees; assists doc­ tors by continuing to help pay for medical malpractice insurance premiums; lowers the cost of uncompensated care for hospitals ($1.4 billion a year); and adds funding to every insurance premium to lower premium costs. see also pa abc highlights, http://www.hacd.net/budget/ 200809/documents/pa%20abc%20highlights.pdf. 2008] the recent state rally for health care reform 299 the p aabc plan represents a significant step forward and builds upon other important measures passed by pennsylvania in 2007 which included: seed money for new federally qualified health centers, a comprehensive hospital in­ fection control law, wellness mobiles, and expanding the scope of practice for nurse practitioners to be able to perform more primary care functions. if passed, pennsylvania's plan will mark the largest movement in covering the uninsured since the introduction ofmassachusetts' plan and will mark a signifi­ cant step forward in the reform movement. 4. indiana in january, 2008, the healthy indiana plan ("hip") began enrolling par­ ticipants into the state's new health coverage program signed into law in july, 2007. indiana has approximately 560,000 chronically uninsured, and the hip plan is designed to cover 130,000 of the uninsured.93 indiana's plan was pre­ dominantly financed through a 1115 waiver and a ¢.44 cent increase in the cig­ arette tax that is estimated to generate approximately $145 million in annual revenue. individuals who have personal income up to 200% fpl, who are aged eighteen through sixty-four, are u.s. citizens, and have been uninsured for at least six months are eligible for hip.94 the indiana plan has gained attention through the use of a health savings account model. the deductible for the plan is $1100 of which the premium payment is paid through a state-subsidized per­ sonal wellness responsibility account ("power"). the power account con­ tains the monthly contributions made by participants, which is based on a sliding-scale of the individual's income. the total individual contribution starts at two percent and cannot exceed more then five percent gross family income. in addition, participants are given pre-deductible $500 free preventive care as an incentive to engage in primary care. any funds not used by the end of the year roll over to reduce the individual or family's obligation in the next year. in order to roll over the state's portion of the contribution to the power account, the individual must engage in the pre-deductible preventive care services. if the preventive care is not used, the state's contribution does not roll over and will be returned to the state. the program provides a lifetime benefit of$1 ,000,000 with the annual benefit not to exceed $300,000. under the indiana plan, cover­ age includes: inpatient and outpatient services, mental health treatment, chronic disease management, medications, home health services, and diagnostic testing. while dental and vision are not covered, there is an optional plan available to cover these services. 93. healthy indiana plan overview: general training, http://www.state.in.us/fssalfiles/ final-_ hip_ general_ tmining_powerpoint.pdf. 94. in.gov, healthy indiana plan, http://www.in.gov/fssalhip/ (last visited apr. 26, 2008). 300 indiana health law review [vol. 5:277 5. new mexico new mexico's governor unveiled the state's "health solutions" plan in october, 2007. it is designed to provide all new mexicans with health insur­ ance coverage.95 the plan calls for employers to contribute to a central fund, with employers receiving a dollar for dollar offset if they are already providing contributions for their employees' health insurance. other major parts of the plan include: increasing the medical loss ratio for insurers to 85%; guaranteed issue ofhealth insurance regardless of pre-existing condition; and a moratorium on new insurance benefits through 2010. in addition, the new mexico plan calls for use of health information technology to manage claims and share pa­ tient data across provider sites and creates an over-arching governmental au­ thority to manage the state plan that will have accountability for all policy issues. n. funding analysishow is health reform being financed? a. medicaid a constellation of funding methods will be necessary to enact, administer, and sustain the wave of new health care reform. as states struggle to creatively keep their budgets balanced, the current reform initiatives hint at interesting, but predictable financing trends. while review of every funding source or stakeholder burden is beyond the boundaries of this discussion, the new plans demonstrate a strong reliance on the following: medicaid waivers, highly struc­ tured employer and employee mandates, and inventive taxation schemes. medicaid is an expensive piece of the financing pie for every state, as total medicaid costs reached over $315 billion of expenditures in the united states for 2006.96 the average state medicaid enrollment is around fourteen percent, with many clients in these systems having disabilities and other serious health problems that are expensive to treat.97 with medicaid playing such a signifi­ cant role in financing health care for the poor, it is almost certain that the fed­ eral government will continue to provide some level of support that will leverage federal dollars for health coverage expansion. with a growing federal budget deficit, and with states suffering from a recession and economic turmoil, many states are leery of leveraging more medicaid dollars as the federal gov95. healthsoumonsnew mexico: affordable,accessffile & accountable(2007), available at http://www.hsd.state.nm.us/mad/pdf_files!salud _ rfp/healthsolutions _ nm _ exec_prop _1 0-25-07.pdf. 96. kaiser f am. found., statehealthfacts.org, http://www.statehealthfacts.org/ profileind.jsp?ind= 177&cat=4&rgn= 1 (last visited apr. 20, 2008). 97. kaiser fam. found., state medicaid facts sheet for indiana and united states, http://www.kff.org/mfs/medicaid.jsp?rl =in&r2=us (last visited apr. 20, 2008). 2008] the recent state rally for health care reform 301 emment threatens additional medicaid cut-backs.98 states, however, have de­ cided to implement strategies that use federal dollars in the short-term as a means to get their new initiatives off the ground while seeking alternatives for sustained funding that does not involve increasing federal support. many hope that savings will be realized from the reform packages implemented in the near term which will provide a return on investment in a few years providing an off­ set that will decrease the reliance on future federal support. in addition, some states, such as indiana, are trying to find general funds elsewhere to minimize their commitment to matching medicaid dollars through the use of creative tax­ es and patient cost-sharing. as previously discussed in the plans above, medi­ caid expansion, whatever its form or amount (as noted in the ora discussion), will be critical to the short-term funding ofhealth care reform initiatives around the country. medicaid waivers gained popularity under the clinton administration as requirements were loosened to encourage more states to use the waivers to at­ tempt new health care initiatives. 99 as previously discussed, popular in the cur­ rent round of reform have been the use of 1115 waivers that created under the social security act.100 the 1115 waivers provide fmancial funding for states to experiment with health care delivery models that in many cases expand cover­ age to individuals who do not qualify for traditional medicaid. as evidenced with the vermont and massachusetts plans, 1115 waivers have been critical to funding new initiatives; massachusetts leveraged $385 million over three years and vermont $135 million over five years with the assistance ofwaivers.101 while 1115 waivers are helpful in funding new initiatives, waiver money is available only for a specified time with no guarantee of additional waiver mon­ ey offset in the future. medicaid 1115 demonstration waivers make sense for states that need upfront capital to implement a program before realized savings can be reinvested back into the subsidized health plan. medicaid waiver ex­ pansion allows states the flexibility they need to tailor plans and coverage unique to their populations, health demographics, and geographic constraints. b. mandated employer and consumer coverage consumer and employer mandated participation in some form is a feature that will likely be utilized by most states seeking to instill ownership and partici98. the dra will institute $11 billion in medicaid cuts over five years with additional medicaid cuts also being considered by congress. 99. eleanor d. kinney, clearing the way for an effective federal-state partnership in health reform, 32 u. mich. j.l. reform 899,911 (1999) (describing how president clinton championed 1115 waivers to help spur health reform at the state level). 100. public welfare amendment of 1962, pub. l. no. 87-543, sec. 122, § 1115, 76 stat. 172, 192 (amending social security act)( codified as amended at 42 u.s.c. § 1315 (1994)). 101. see waldman, supra note 58; see also 2006 health care reform initiatives (2006), http://www.leg.state. vt.us/healthcare/2006 _health_ care_ constituent_ information _sheet.htm (last visited apr. 20, 2008). 302 indiana health law review [vol. 5:277 pation in the reform process. success, however, may be limited if the mandates are not married with affordable choices for consumers that provide reasonable coverage. while mandates create immediate opportunities to expand coverage, states must proceed with caution in how the mandates are structured in order to ensure that citizens and businesses are not priced out of the process. employers have traditionally provided health insurance coverage, but have often done so with tax subsidies that offset their out-of-pocket costs.102 states realize that mandating employer coverage may be an easier conditional requirement given the historical model of employers providing health insurance to employees. states must be careful, however, not to ask employers to shoul­ der too much ofthe health care expense. in particular, small and medium-sized businesses may become disproportionately burdened with additional cost­ shifting, impeding their ability to grow and remain competitive.103 states are mindful of the economic ramifications of stretching businesses too thin, but current reform efforts reveal that states are relying on employers to pay their fair share as a partner in reform. although cost savings for employers may be difficult to come by over the short-term, many states are hoping that long-term commitments from employers to the reform processespecially with smaller companieswill ultimately mean costs savings for employers and a healthier and more productive work force. on the consumer side, mandated plans actually create many of the same potential financial problems as noted previously with employers. while man­ dating health coverage is an easy way to achieve "universal care," if premiums and costs remain too high and ifthere is no effort to create health plan coverage that fits all socioeconomic classes, the mandate will create a false safety net where many are left without care and penalized for not being able to participate in the state-sponsored plans. to some extent, this has proven to be the case in massachusetts, which is currently the only state to mandate coverage for all of its citizens. for example, when the massachusetts state insurance committee met to review and negotiate the plan premiums, the average premium price was calculated to be $380 per month. this premium price, almost double the pre­ dicted $200 per month, is beyond the reach of many intended beneficiaries. 104 some fear these increases in required payment will lead to court challenges and public protest that may ultimately doom the program. 102. carolyn v. juarez, liberty, justice, and insurance for all: re-imagining the em­ ployment-based health insurance system, 37 u. mich. j.l. reform 881, 886-87 (2004) (report­ ing that employers are given tax incentives that approach $100 billion, creating a default system where the federal government is essentially already paying half of current health insurance pre­ miums). 103. id. at 887-89. 104. alice dembner, sticker shock for state care plan, boston.com, jan. 20, 2007, http://www.boston.com/news/local/massachusetts/articles/2007 /0 1120/sticker shock for state c are _plan/ (last visited apr. 20, 2008). 2008] the recent state rally for health care reform 303 c. state taxing schemes covering the high costs of health care reform has led to creative taxation schemes that underpin most of the current reform plans. without question, ad­ ditional taxation beyond the simple redistribution of general state revenue will be needed to cover what are, not surprisingly, very expensive initiatives. as states scurry to find funding alternatives to minimize pulling additional dollars from their general funds or leveraging additional medicaid dollars, three taxing schemes have emerged as possible candidates to be replicated in other states: 1) "sin" taxes or tobacco taxes; 2) provider and insurer taxes; and 3) employer payroll taxes or "pay-or-play'' contributions. 1. sin and tobacco taxes the easy target of cigarette taxes is gaining popularity as a way to gener­ ate income for health reform given the strong association of tobacco products to health problems and disease. the average state tax is now at one dollar per pack with the range from a low of ¢.07 in south carolina, to a high of$2.54 in new jersey. 105 every major state proposal thus far contains some form of a tax on tobacco products which in some cases is the major source of funding ofthe health reform plans. while other taxes have been used with respect to alcohol, there are some consumer groups advocating taxes on soft drinks or even fast­ food, but there must be more interest from state legislatures if such taxes are to be formulated. 2. provider and insurer taxes second, and more controversial, are tax proposals that will be levied against major health care stakeholders specifically the insurance industry, hospitals, and doctors. while these taxes will likely be challenged, the new wave of reform has given states political courage to challenge the traditional heavy-weights of the health care system. in maine, for example, the savings offset plan tax on health insurance transactions was designed to create an incen­ tive for the insurance industry to participate in reform and to avoid the cost­ shifting of uncompensated care in the form of increasing premiums to those with insurance. maine hopes that over time the tax will actually prevent losses to insurance companies by providing additional savings for all stakeholders re­ alized by the state's funding of the uninsured. maine further justified the tax as the insurance companies were given the contract to administer the state health 105. american lung association, good news:smoke-free workplace laws, cigarette taxes increase, searchlung usa. jan. 9, 2007, http://www.lungusa.org/site/apps/s/ content.asp?c=dvluk900e&b=34706&ct=3383613 (last visited apr. 20, 2008). 304 indiana health law review [vol. 5:277 plan and are now partners with the state in driving the economic change in health reform. governor schwarzenegger's california proposal utilized a similar argu­ ment by initially proposing a plan to tax doctors and hospitals. schwarzenegger had justified the health provider tax by stating he would use the levy to finance california's insurance subsidization plan which would then offset uncompen­ sated losses to hospitals and providers. new jersey, however, did successfully adopt a provider tax to fund their uncompensated fund by levying a 3.5 percent tax on privately held ambulatory surgical centers and a six percent tax on gross receipts on physicians performing cosmetic procedures.106 while the provider tax trend has not played out in many state legislatures, it is certainly an option being discussed, especially in states where certificate-of-need laws are not in force. 3. employer taxes employer payroll taxes, and "pay-or-play" contributions, have been wide­ ly considered for those who refuse to provide coverage for their employees. adding employer payroll taxes seem an easy target to generate revenue, but as has been the case and will be discussed below, many taxes designed as an em­ ployer mandated payment for health care fall under the preemption umbrella of the employee retirement income security act ("erisa"). as more states consider employer mandates, congress may be forced to pass erisa revisions or alternatively, the courts may find erisa does not apply to health reform efforts. but until then, levying an employer tax certainly invites political and legal challenges. it could be the case, however, that congress increases the op­ tion for federal payroll taxes as already provided for with medicare coverage. given the size and scope of medicare and the payroll tax already in place, ex­ pansion of this program may be the low-hanging fruit visited first by the new president in 2009 as a means to expand care to more individuals under a federal plan. d. health savings accounts and high deductible health plans increasingly, many employers and states are considering the use ofhsas in conjunction with high deductible health plans ("hdhp") as a means to de­ crease expenses by sharing costs with participants. these types of plans have been touted by the bush administration and other political conservatives107 as a 106. n.j. stat.ann. § 53:3125 (west2004)(sixpercentcosmetic levy); n.j. stat. ann. § 54:3127 (west 2004) (3.5 percent surgery clinic levy). see also robert e. hurley et al., a widening rift in access and quality: growing evidence of economic disparities, healmaff., web posting dec. 6, 2005, http://content.healthaffairs.org/cgi/content/fulllhlthaff. w5.566/dci (last visited apr. 20, 2008). 107. republican presidential hopeful john mccain has championed hsas as a means to 2008] the recent state rally for health care reform 305 strategy to curb increasing health care costs. hsas and hdhps have yet to significantly reach the mainstream, but are predicted to account for twenty-four percent of the future health insurance market by 2010.108 the combination of hdhps with hsas has thus far been met with mixed reviews. while there is hope that a positive economic impact will result in decreasing health care utili­ zation, hsas have not been shown to help those in the uninsured ranks. 109 fur­ ther, the theory behind hdhps is to incentivize the wise use of health care to prevent unnecessary over-utilization of health care goods and services that some believe has historically been fueled by traditional lower deductible plans.110 in reality, what appears to be occurring is that hdhps are curbing costs at the expense of sacrificing health care quality and access as many clients using hdhps are putting off care due to the increased deductible and associ­ ated out-of-pocket expenditures.111 these combination plans will likely con­ tinue be a common reform component, but their success will hinge upon whether participants feel they can afford the increased out-of-pocket costs that these types of plans often require. states must find ways to maximize subsidi­ zation of hdhps with the use of hsas in order to incentivize consumers to seek health care services, especially preventive care. reform efforts, as wit­ nessed in indiana, seem to understand this concern and have addressed the is­ sue by doing the following: making the hdhp deductible subsidy tied to a cigarette tax, limiting participant investment to no more than five percent of gross total family income, and including a set amount of free preventive health care that is subsidized by the state. 112 although this section focuses more on the taxation schemes being utilized by the states to generate revenue, it should be noted as part of this discussion that there have been federal proposals under the bush administration to provide tax breaks to incentivize consumers to purchase health insurance that presents a viable alternative to expanding coverage. as discussed previously, president bush has been proposing a standard tax deduction of$15,000 for families and $7500 for single americans whether they have employer-provided health cov­ erage or they purchase health coverage independently.113 the tax credit fits in as part of the president's plan to shift accountability to consumers by incentivcontrol health care costs and has featured hsa use as part of his health care plan for america. see johnmccain.com, http://www.johnmccain.com!informing!issues/19ba2fl c-c03f-4ac2-8cd55cf2edb527cf.htm (last visited apr. 26, 2008). 108. philip betbeze, the banks are coming, heal1hleadersmagazene.com, dec. 14, 2006, http://www.healthleadersmedia.com/view_feature.cfm?content_id=85773 (last visited apr. 26, 2008). 109. hoffinan & tolbert, supra note 36 (reporting that the combination ofhdhps and hsas work best for those who are wealthier, healthier, or have significant employer contribu­ tions to off-set high out-of-pocket costs). 110. ld. 111. id. 112. see in.gov, healthy indiana plan, http://www.in.gov/fssalhip/ (last visited apr. 26, 2008). 113. the whitehouse, strengthening health care, http://www.whitehouse.gov/infocus/ healthcare/ (last visited apr. 20, 2008). 306 indiana heal til law review [vol. 5:277 izing personal choice and responsibility. critics of the plan contend that only three to five million of the uninsured will be covered with the tax credit, and that the president's plan does nothing to hold insurance companies accountable to address the spiraling costs of premiums which are often consumers' main obstacle to obtaining coverage. 114 tax credits and other federal incentives, however, demonstrate a possible connection that can be made by the federal government, in addition to incentives at the state level, to promote health cover­ age expansion. the topic of tax credits and other possible federal funding schemes is currently a top issue being discussed among the presidential candi­ dates.115 v. the stakeholders fight back as major stakeholders like the insurance industry become increasingly targeted as part of the reform efforts, it is not surprising that most will resist the state and/or federal government's attempt to redefine their role in the health care system. two recent legal actions may signify a precursor to what other states may face in the way of legal challenges to their new initiatives. a. insurance industry the insurance industry remains the major player that will not be moved easily from its entrenched position in the health care system. although most state plans have found a way to include health insurance companies in the re­ form process, it is clear that reform-minded states are beginning to have a more profound influence on how insurance companies do business. 116 as a result, insurance companies are testing state plans quickly and vigorously in court. one example of this can be found in a recent lawsuit filed by a major health insurance company, anthem, in conjunction with state business leaders against the state ofmaine. 117 in maine ass'n of health plans v. superintendent of ins., the insurance industry claimed that maine's 2.4% savings offset payment represented an "im­ proper delegation" ofthe legislature's tax power. 118 the insurance company 114. see gardner, supra note 37. 115. see kaiser f am. found., 2008 presidential candidates health care proposals: side­ by-side summary, http://www.health08.org/sidebyside.cfin (last visited apr. 20, 2008) (presi­ dential candidates barack obama, hillary clinton, and john me cain have all proposed either federal tax credits or federal subsidies for individuals and employers to assist with purchasing health insurance. hillary clinton is the only candidate proposing an individual mandate). 116. sharona hoffinan, unmanaged care: towards moral fairness in health care cov­ erage, 781nd. l.j. 659, 713-18 (2003). see also hermer, supra note 13, at 82 (2005). 117. maine ass 'n of health plans v. superintendent oflns., 923 a2d 918 (me. 2007)(the maine supreme court affirmed the lower court's decision holding that the state's ability to assess the insurance premium adjustment payable by health insurance companies to support the state health plan was legally viable). 118. id. 2008] the recent state rally for health care reform 307 argued that the legislature did not legitimately construct the tax and that the payment therefore fell under the void for vagueness doctrine which made the provision unconstitutional. the court disagreed and ruled in favor of maine. in the opinion, the court provided a detailed analysis of the offset payment system and held that the offset was an appropriate and legitimate method by which the legislature could redistribute funds to pay for additional health care under the general police power of the state. regarding the constitutional argument, the judge stated that the universal health care statute was sound, as there was no evidence presented by the insurance company that the maine legislature had overstepped its authority in delegating to the dirigo health agency board the ability to calculate the offset. 119 while this case represents an early challenge in one jurisdiction, the result is nevertheless significant, as the decision represents an early victory for a state seeking to find innovative strategies to create univer­ sal health care. the decision also symbolizes a shot across the bows of insur­ ance companies, putting them on notice that states may be gaining more authority to regulate the insurance industry as health care reform efforts con­ tinue. many in the insurance industry realize reform efforts are here to stay and that the times are rapidly changing regarding provision ofhealth care. 120 while insurance companies will continue to be a dominant voice at the negotiating table, their participation in the process will be hedged towards warding off re­ form efforts that shrink their bottom lines. thus far, the health insurance indus­ try is injecting its "own" ideas that appear to be disguised marketing campaigns, which do not truly offer any unique solutions to the health care cri­ sis. for example, insurance companies have endorsed efforts that include pro­ moting high deductible health plans to capture younger, healthier, uninsured clients, 121 encouraging higher taxes on cigarettes, service charges on patients for each visit to their health care provider, tax credits, and a payroll levy for employers who do not cover their employees. 122 with all of the insurance company proposals, there remains the need for more discussion about reigning in premium costs and more discussion about administrative costs paid to the bottom line. health insurers, however, are be­ ing forced to move toward a more lean business model where dramatic shifts in administrative costs and actual health care dollars paid against increasing medi119. id. 120. juarez, supra note 102, at 889-90 (noting insurance companies history of fighting back against reform with high profile campaign and lobbying efforts). 121. robert kazel, wellpoint/blue cross finds profits in high deductibles for young and healthy, am. med. news, jan. 17, 2005. http://www.pnhp.org/news/2005/january/well point­ blue_ cross.php (last visited apr. 20, 2008) (noting that wellpoint is exploiting a market niche to increase the company's profit). 122. lisa girion, insurers have own ideas on coverage, latimes.com, jan. 22, 2007, http://www .latimes.comlbusiness/la-fi-insure22jan22, 1, 7202037 .story?ctrack= 1 &cset=true (last visited apr. 20, 2008). 308 indiana health law review [vol. 5:277 cal-loss ratios are well underway in the marketplace. 123 with so many individu­ als having employer-based insurance and by having access to valuable patient health information and provider practice behaviors, the insurance companies are uniquely positioned to continue to play a key role and will still wield much power in the health delivery process. while there is much anti-insurance com­ pany sentiment from some advocates engaged in the reform movement, the fact of the matter is that the health insurance system has been in place for so long that it cannot be easily unwound in a few years. there is no doubt that redefin­ ing the health insurance company's role in the health care system will require assessing creative options for all stakeholders to see what makes the most eco­ nomic sense. while public-private initiatives may be a wise move for states with respect to partnering with the insurance industry to provide coverage for services, this collaborative model will likely require walking a fine line between profits and true reform. both sides must enter the reform process committed to ensuring reasonable costs and coverage for all citizens. states must realize that they have the power to push for change and must ultimately find a way to be collaborative, while still being forceful in challenging health insurers to be more transparent and competitive in their pricing plans. b. employers much of the reform debate has focused on alleviating the burden of high health care expenditures on employers. with nearly 250 million individuals still tied to some form of employer-based insurance plan, it seems unlikely that an un-tethering of employer-based insurance will occur any time soon.124 states are well aware that as employees opt out of employer-based plans, further stress is placed on the state to create some type of coverage alternative. the question remains, however, whether employer contributions can continue into the fore­ seeable future as central means to support health insurance coverage. while some larger employers may be in a better financial situation to provide benefits, these same employers have found themselves battling new health reform initia­ tives. while most employers welcome the addition of health care for their em­ ployees, some worry that plans may place them at risk if the plans are not structured properly or create additional fmancial burdens. like the insurance industry, employers potentially stand to lose a lot of autonomy as reform efforts 123. daniel lee, what'sailing wei/point?, indianapousstar,apr.l3, 2008, atdl (in early 2008, wellpoint has faced a year in which money paid on medical claims versus premium revenue (medical-loss ratio) is expected to increase by 2.3% over the past three years. although wellpoint has trimmed its administrative costs down to 14.5% in 2007 from 16.5% in 2005, the company continues to be battered by higher payouts for physician services, oncology care, and neonatal intensive care. as of april 2008, company stock had plummeted in value by 47% compared to the beginning of2008). 124. see denavas-waltet al., supra note 5, at26 (noting 201.7 million have private insurance and 80.3 million have government-sponsored health insurance). 2008] the recent state rally for health care refort\1 309 evolve, forcing employers to challenge proposals that increase their responsibil­ ity to pay for and provide health coverage. in one noteworthy case, retail industry leaders ass 'n v. james fielder the large retailer wal-mart filed a lawsuit protesting the maryland health re­ form package. 125 as previously discussed, the proposed maryland statute re­ quired for-profit employers with over 10,000 employees who did not provide coverage to pay the equivalent of eight percent of the employees' payroll to cover health care. in this case, wal-mart is the only company in maryland that meets the statutory minimum of 10,000 employees. wal-mart contended that the required contribution was preempted by erisa and also violated the equal protection clause of the united states constitution.126 the court ruled that the eight percent mandate was not a tax per se but did conclude that the maryland statute was preempted by erisa and nullified the revenue payment required under the maryland statute.127 the court stated that wal-mart could not be forced by maryland to provide benefits in one manner in their state and then be expected to provide the same benefits in a different manner in other states. the effect ofthis case has been to halt the enactment ofmaryland's plan that was passed last year. while the intent of this plan was to incentivize em­ ployer coverage, it appears to be poorly designed in that it legislatively isolates one large employer. other states have considered similar employer-mandated "pay-or-play" bills, but it remains to be seen if court decisions like this could impact their efforts moving forward or if it will force states to consider other avenues for integrating employer mandates into their reform plans. vi. an un-integrated system: policy considerations to keep on the table while there are divergent views on how to fix the health care crisis, many would argue the time is ripe for a nationalized single-payer system. the politi­ cal will to take this monumental step, however, is lacking and the health care crisis will not be easily fixed by simply implementing a uniform payer under a federal health program. such a plan would be short-sighted if other policy con­ siderations are not examined as part a comprehensive and meaningful federal reform package. further, jumping quickly into a federal single-payer system, without a well planned strategy, will be a hard sell to many who still favor in­ cremental reform-just ask hillary clinton. as states have recently moved forward in their various plans, several important policy considerations have emerged that make sense during this short-term burst of reform. as the current state plans come into view, it is apparent that state legislators' recognition of a more broad approach to health care reform is required to modernize and update 125. retail indus. leader ass'n v. fielder, civil no. jfm-06-316 (md. dist. ct. 2006), available at http:/ /www.mdd.uscourts.gov/opinions 152/0pinions/w almartopinion. pd£ 126. id. 127. !d. 310 indiana health law review [vol. 5:277 systems to reach the goals of a cost-effective, efficient, and quality health care delivery system. with the states leading current efforts, it is time for the federal government to take note and pursue a more aggressive stance on reform. listed below are policy considerations that the federal government might use to work with the states to spur on the innovation needed to succeed in meeting the fu­ ture health care needs of our country. a. iriformation technology one of the most important initiatives that both state and federal govern­ ments must support in order to successfully move the health care system for­ ward will be the effective use of information technology ("it"). although most other major industries understand the importance of harnessing the transforma­ tive powers it can provide, the health industry has been generally slow to adopt and incorporate it into the care delivery process on either the provider or con­ sumer end. investment in health care it integration has the potential to trans­ form how care is provided, research is conducted, and the manner in which patients and providers are educated and interact with the health care system. the intersection ofit and computer-assisted care has the potential to radically change and influence the way care is provided whether it be it integration with the doctor operating in a surgery suite, the sharing oflab data with a nurse prac­ titioner in a rural primary care clinic, or having the ability to virtually interact with a patient through their home computer or cell phone. while computer and cell phone applications related to the health care industry are cropping up eve­ rywhere, the adoption and use of it in areas such as tele-health initiatives, qual­ ity measurement and tracking, and sharing data across institutions and clinic sites is in many ways only just beginning to be integrated in a meaningful man­ ner in the health care industry. while there are many political, economic, and legal obstacles to overcome when creating a nationwide network of shared pa­ tient and health data, the promises of improved patient outcomes, safety, and the efficiency and cost-savings that can be realized from integrating health it requires a meaningful and sustained government initiative to move it integra­ tion and utilization forward. 1. electronic medical records and regional health information organiza­ tions: connecting the health jriformation dots as already noted above, although the digital-age is well under way, the u.s. medical community lags behind other industrialized countries in moving from a paper-based medical records system to an electronic medical records ("emr") system.128 utilizing emr is a necessary first step to creating a more 128. edward h. shortliffe, strategic action in health information technology: why the obvious has taken so long, 24 healthaff. 1222, 1222-33 (2005) (historically there has been 2008] the recent state rally for health care reform 311 efficient system that will benefit providers and consumers alike, and it has the potential to save as much as eighty-one billion dollars per year in health care costs.129 benefits ofemr include: easy twenty-four hour access to current and accurate patient information, increased safety when reviewing potential drug interactions, improved ability to contact previous providers, confidence that the right information is being shared, increased knowledge of the patient regarding their health, improved potential to reduce patient care errors, and less ordering of needless duplicative tests. 13° currently many hospitals and provider clinics are at various stages of adopting emr platforms, which has created a partially integrated and fragmented information system that frustrates many providers. 131 this fragmentation has been largely due to competition of various it vendors which has created a system where the various it systems fail to "talk" to each other. successful emr adoption will require that it systems and databases be able to communicate in order to realize the full benefits of efficiency. imple­ mentation of emr, however, will not be without difficulty as overcoming the issues of cost, ease of use for providers and other clinic staff, and implementa­ tion across institutions will require coordination of many parallel systems of data collection.132 currently, around the country local health care providers and regional government officials are advocating a more integrated approach to finding a solution to the inability of providers to share health information across institu­ tions. regional health information organizations ("rhio"), sometimes re­ ferred to locally as health information exchanges ("hie"), around the country are beginning to set up commonly shared foundational databases designed to improve accessibility and coordination among providers. 133 the goal of the rhios is to try and build a common platform that can be used and integrated into any provider or applicable research network for the purpose of sharing pa­ tient and health data. although in its embryonic stages, hies and rhios are beginning to take hold around the country, and there are now approximately 100 organizations in various stages of setting up an hie or operating as part of no shortage of ideas on how to apply it into the care process, but attitudes regarding being able to use it appropriately in addition to the high cost of infrastructure expansion have proven to be difficult for all stakeholders). see also dena e. rifkin, electronic medical record5: saving trees, saving lives, 285 jama 1764, 1764 (2001). 129. richard hillestad et al., can electronic medical records transform health care? potential health benefits, savings and costs, 24 health aff. 1103, 1103-117 (2005) (full­ scale implementation ofemr will have an immediate impact on chronic disease management and will also have tremendous benefits with respect to patient safety and disease prevention). 130. thomas bodenheimer & kevin grumbach, a spark to revitalize primary health care?, 290 jama 259, 259-64 (2003) (discussing the positive impact for health providers in being able to readily exchange health information). 131. david gans et al., medical groups adoption of electronic health records and in­ formation, 24 helath aff. 1323, 1323-33 (2005); see also ashish k. jha et al., how common are electronic health care records in the united states? a summary of the evidence, 25 helathaff. w496, w496-w505 (2006). 132. see hillestad et al., supra note 129, at 1114-15. 133. see generally julia adler-milstein et al., the state of regional health information organizations: current activities and financing, 27 helath aff. w60, w60-9 (2008). 312 indiana health law review [vol. 5:277 a rhi0.134 many of these organizations are still in the planning phases while others have actually agreed to a common platform and shared data set that is being shared. 135 while financing these projects has proven to be expensive and sustainability remains a real question for some of the newly formed networks, states that are able to support and connect to a centralized database will more quickly realize savings in having a single on-line integrated system that creates a common database for clinicians and other stakeholders. in addition, invest­ ment in the health it infrastructure will drive other industries such as the life sciences which will require a completely new business model for building the jobs ofthe future. public financing should continue to support the transforma­ tion ofhies and rhios into sustainable business models that play key roles in improving the efficiency of the health care system. 136 in this new era of information technology, patient advocates are concerned that health information could end up in the wrong hands if not properly pro­ tected. 137 the responsibility and the success of a shared patient medical records system will lie with legislators and system users who must insist that every measure be taken to protect the privacy of patient information. any erosion of public faith on this issue could wreak havoc in trying to build political will for reform in other areas. further, while strict enforcement of privacy through the health insurance portability and accountability act ("hip aa")138 laws must continue; these regulations should not hamper a coordinated effort to accelerate the use of emr to enhance care and save health care dollars. 139 the federal government's partnership can play a critical role in ensuring regulations are enforced fairly, but also in a manner that promotes health care innovation. 134. /d. at w63. the study suggests that there are currently around 102 entities operating around the u.s. as a rhio with approximately thirty-two actually sharing information and ap­ proximately twenty organizations conducting more robust networking and data sharing. 135. /d. at w64-5. the study noted that some rhios have set up more complex data sets that include the sharing of patient histories, outpatient information, lab results, and medication management data whereas others are more limited in their data sharing, tracking specific disease processes such as one rhio trying to capture pediatric asthma utilization data. 136. /d. at w65-7. with respect to financing rhios are heavily dependent on grants, in­ kind donations of time, and public financing support. most rhios are new business models and are trying to strategically align themselves in the communities they operate to show their value. some rhios are charging a user fee as a way to increase sustainable funding. of all the rhios identified in the study only eight to twelve rhios have sustainable funding in place. 137. sean mclaughlin, pandora's box: can hip aa still protect patient privacy under a national health care information network?, 42 gonz. l. rev. 29, 37-40,49-52 (2006) (dis­ cussing that a national health information system must have sufficient safeguards in place in order to successfully implement emr while protecting patient privacy). 138. health insurance portability and accountability act ofl996, pub. l. no. 104-191, 110 stat. 1936 (codified in scattered sections of26, 29, and 42 u.s.c.). 139. mclaughlin, supra note 137, at 60. 2008] the recent state rally for health care reform 313 2. chronic disease management: getting control early chronic disease management for common illnesses such as hypertension and diabetes is another key area states have identified as critical to containing health care costs.140 approximately 1. 7 million people die each year as a result of chronic disease.141 estimates indicate that ninety million people in the unit­ ed states live with a chronic disease, which amounts to seventy-five percent of the annual $1.4 trillion health care budget.142 the disconnect between reim­ bursing chronic health care initiatives and poor health outcomes has become an issue not only for clinicians, but also for third party payers that ultimately play a major role in financing care related to chronic diseases. 143 recent state reform efforts, as outlined previously with vermont, demonstrate the recognition that no health care reform effort can be complete without addressing care surround­ ing chronic health concerns that consume a large amount of state budgets. the success of any state plan will be due in large part to the ability of states to ag­ gressively decrease the economic burden of chronic disease. chronic disease management will have the most impact where focused on decreasing disease occurrence within the general population while also aiming to improve the health of citizens living with chronic diseases. 144 as part of their reform efforts, states must be committed to offering plans that feature chronic disease pro­ grams tied to education and health promotion. in order to reach the uninsured more quickly, improving chronic care disease care could be achieved by in­ creasing funding to community health clinics and utilizing public health nurses to provide residential follow-up and education needed to increase care compli­ ance. further, as discussed above, the integration ofit in coordinating care for those with chronic disease will be crucial to controlling health care costs. in addition to using it to send patient reminders about appointments and medica­ tion changes, it can be used to design a "virtual care plan" where patients that require intense monitoring can have information from a medical device or other treatment data routed directly into their provider's office. and more impor­ tantly, providers can be linked to each other to ensure collaboration is enhanced as part of the patient care plan. 140. see also a public health action plan to reduceheartdisease and stroke; an executive summary, ctr's for disease control, http://www.cdc.gov/dhdsp/library/ action_plan/pdfs/action_plan_short.pdf. 141. ctr's for disease control, profiling the leading causes of death in the united states, http://www.cdc.gov/nccdphp/publicationslfactsheets/chronicdiseaselpdfsl 00 _ chronicdiseaseaiistates.pdf. 142. ctr's for disease control, costs of chronic disease, http://www.cdc.gov/ nccdphp/overview.htm#2. 143. jennifer l. wolff & chad boult, moving beyond round pegs and square holes: restructuring medicare to improve chronic care, annals of internal med. 493, 439-45 (2005). 144. paul a. nutting et al., use of chronic care model elements is associated with high­ er-quality care for diabetes, annals off am. med. 14, 14-20 (2007). 314 indiana health law review [vol. 5:277 typically, patients (especially those with chronic illnesses) may need ac­ cess to many different resources to properly treat their individual health needs. many individuals have chronic conditions, such as mild asthma, which may have only a minimal impact on their daily activities and can be easily managed through routine primary care. other individuals have multiple or complex chronic conditions such as advanced diabetes or heat disease, that requires ex­ tensive care management across many different specialties. currently when a patient seeks care for multiple problems, such as with a chronic illness, they often receive services with little or no coordination between providers.145 spe­ cialty and primary care providers often administer parallel patient care where there is minimal effort or ability to share information or a treatment plan regard­ ing a common patient. for example, one patient may see doctor a, a specialist, and then see primary care doctor b two weeks later for the same condition, un­ aware of what doctor a prescribed or what tests were ordered. this lack of communication and coordination leads to many problems including: unneces­ sary expenditures and administrative waste, repeat of needless procedures, the loss of critical patient information, treatment delays, jeopardizing of patient safety, and complication of on-going treatment plans. this dislocation in care is often driven by many factors such as insurance coverage, provider behavior, institutional boundaries, staffing, or technology availability to gather and ex­ change data.146 successful and efficient patient outcomes can only be brought about through increased efforts to share patient information between providers, linked by innovative it programs. these coordinated efforts need to be tied to best practices and clinical outcomes that can be measured and shared across clinic sites as standard treatment plans that define the acceptable level or type of care the patient should receive. when considering the over-utilization ofhealth care dollars, the first place to examine closely should be right in the provider's office, as doctors directly and indirectly control approximately eighty percent of all clinical costs. 147 al­ though the transaction that occurs between provider and patient has a strong cultural and legal history of being sacred and off-limits, this relationship is no longer beyond scrutiny in a climate driven by cost-effective care. one strategy being utilized in the clinical setting to enhance care and control costs is the use of clinical practice guidelines ("cpgs"). cpgs provide a scientific, evidence­ based approach to providing care that creates a clinically tested means to ad­ dress the challenges of providing care that is both superior and cost-effective.148 a simple example of the effective use of a cpg could be illustrated in the 145. see george halvorson, health care reform now 211-18 (2007). 146. id. at 33-57. 147. stefani daniels & richard reece, the business case for hospital case management, healthleader.news, mar. l, 2007, http://www.healthleadersmedia.com/viewfeaturel 87605.html (last visited apr. 20, 2008). 148. robert steinbrook, guidance for guidelines, 356 new eng. j. med. 331, 331-33, (2007) (discussing how practice guidelines can enhance care across specialties and create a more cost-effective approach to providing care). 2008] the recent state rally for health care reform 315 treatment of a patient with type ii diabetes. if a clinician were to consult a treatment guideline, such as the national guideline clearinghouse, 149 the medi­ cation choices recommended may provide alternative therapies that are effec­ tive and cheaper than the patient's current medical therapy. cpgs ensure that patient treatment plans are benchmarked to specific targets that reflect a stan­ dard of care that has been proven with medical evidence to be an effective care strategy. cpgs provide standards that enhance and improve utilization of health care dollars, while at the same time empowering the patient and clinician to work together to choose from many treatment options that can be tailored to meet the individual patient needs without succumbing to "cookbook medicine" or a "one-size-fits-all" approach to health care. 3. quality measurement and tracking: excellence in care must drive re­ form quality has become the new mantra for health delivery systems in recent years. new programs such as pay-for-performance ("pfp") payment schedules and the desire by providers to implement evidence-based practices that bring about optimal patient outcomes are driving a major redesign effort in the deliv­ ery of care. in addition, all stakeholders in an effort to promote safety, increase efficiency, and contain costs have been looking to define specific quality initia­ tives as a means to measure both the real economic value and clinical value of the services being provided. as noted above, with the discussion of the ex­ change patient and health data and the implementation of practice guidelines especially for those with chronic diseases, it will play a key function in utiliz­ ing data systems to capture the pertinent measurement data needed to measure quality. in addition, standards and measurement guidelines will need to be de­ signed in order to create valid measurement tools. already nationally recog­ nized groups such as the national committee for quality insurance who implement the healthcare effectiveness data and information set ("hedis") evaluation system, and the agency for healthcare research and quality ("ahrq") who provide the consumer assessment ofhealthcare providers and systems ("cahps"), have been blazing a trail to obtaining objective quality data sets and tools that have been used to measure a whole host of treatment processes, plans, and health delivery mechanisms. 150 further, states engaging in health reform have recognized the importance of placing quality first. for example, the three states that have led comprehen­ sive reform efforts, massachusetts, maine, and vermont have created either quasi-governmental or governmental bodies that have direct accountability for 149. see national guideline clearinghouse, http://www.guideline.gov/ (last visited apr. 26, 2008). 150. see national committee for quality assurance, http://www.ncqa.org/tabid/ 59/default.aspx (last visited apr. 26, 2008); see also agency for healthcare research and qual­ ity, https://www.cahps.ahrq.gov/default.asp (last visited apr. 26, 2008). 316 indiana health law review [vol. 5:277 measuring and monitoring quality. maine has the quality forum ("mqf") which grew out of the dirigo health reform legislation.151 the mqf consists of a director that works in concert with an advisory board of providers, consumers and representatives of labor, and other policy agencies. the mqf was de­ signed to foster quality initiatives that promote best clinical practices and track patient data that can show what treatments have the greatest impact on care. the program also links patients to education programs to raise awareness about preventive care and the signs of disease to promote early primary intervention and healthy lifestyle choices. likewise, in 2006, massachusetts developed the health care quality and cost council ("hcqcc").152 the hcqcc was charged by the legislature to oversee actions to improve the health outcomes and utilization of health care dollars. the hcqcc recently defined a compre­ hensive six part plan aimed at: 1) reducing the cost of health care to no more than the unadjusted growth ofgdp; 2) ensuring patient safety and effectiveness of care; 3) improving screening and management for chronic disease manage­ ment; 4) developing and implementing data collection and measurements to improve quality especially in those areas that are underperforming in quality and end-of-life care; 5) eliminating racial and ethnic disparities; and 6) promot­ ing quality through transparency. 153 these health reform quality initiatives rep­ resent the gold standard other states should follow in ensuring a culture and environment of quality is established where optimal patient outcomes is the goal for both providers and patients and where achieving quality and cost­ effectiveness is maximized and rewarded. b. revisiting the core lrifrastructure: patient utilization and provider capacity 1. the construction re-explosion and the subsequent reverberations during the 1990s hospital bed growth slowed, but with the retirement of baby boomers and the renewed competition for market share, the race to build new facilities is back on.154 also contributing to the construction craze has been the evolution of specialty hospitals and joint ventures. 155 while many 151. maine quality fol"lllll. http://www.mainequalityforum.gov/ (last visited apr. 26, 2008). 152. massachusetts health care quality and cost council, http://www.mass.gov/ ?pageid=hqcchomepage&l= l&lo=home&sid=lhqcc (last visited apr. 26, 2008). 153. recommendations for improving heal1h care quality, containing heal1h care costs, and reducing racial and e1hnic disparities in healrn care, http://www. mass.gov!ihqcc/docs/fs _lead_ recommendations. pdf. 154. david shactman et al., the outlook for hospital spending, 22 healrnaff. 12, 12-25 (2003). 155. see lola butcher, too much construction?, healthleaders magazene, oct. 2006, http:/ /www.healthleadersmedia.com/magazine!view _magazine _feature.cfin?content_id=84250 2008] the recent state rally for health care reform 317 question whether the health care sector can simultaneously continue to build new hospitals in the face of escalating costs, others see the new construction as a legitimate response to changes in the health care market. regardless of the perspective, it remains to be seen whether the new explosion of construction is truly adding value to the health care system or simply providing another cost­ shift with smaller community hospitals bearing the brunt of caring for the unin­ sured as hospital systems that are better economically positioned move to the insurance-rich suburbs. with many hospitals struggling to keep beds filled, some states, as part of their reform efforts have questioned whether building new facilities is the right answer. although average daily occupancy is difficult to track, the center for disease control has placed a national average daily cen­ sus for hospitals at approximately sixty percent. 156 as hospitals stretch to keep profitable occupancy rates, states have made reforms to limit capacity ofhospi­ tals by either closing down facilities or strictly enforcing certificate-of-need ("con") requests. 157 as part ofmaine's health care initiative, the government limited con re­ quests in an attempt to minimize needless expansion ofhealth care capacity.158 con restriction is a divisive topic as many fear that too much government reg­ ulation will thwart legitimate efforts to expand health care services that are needed to be relevant in an ever-changing technological environment. 159 states like maine argue that they already have too many facilities that are being un­ derutilized, and that increased building will only add to the over-abundance of under-performing health care facilities. state reform policies must strike a bal­ ance between allowing new facilities to keep current with the state-of-art stan­ dard of care but not so abundant that every metropolitan area has specialty facilities that do not support the population's needs. other states have taken more radical steps. the state ofnew york took a controversial step in late 2006 by proposing the closing of twenty hospitals as part of a cost containment effort.16° citing that 20,000 ofthe 63,000 hospitals (discussing that 2005 witnessed $100 billion in new hospital construction, often times occurring in communities that did not need new patient beds). see also philip betbeze, competition: dj.y. docs, healtiileaders magazene, apr. 2005, http://www.healthleadersmedia.com/mag azinelview_magazine_feature.cfin?content_id=66325 (last visited apr. 20, 2008) (noting the upsurge in physician-owned specialty hospitals). 156. catharine w. burt & linda f. mccaig, stqffing, capacity, and ambulance diversion in emergency departments: united states, 2003-04, anv ance data from vital and heal til statistics, ctr's for disease control & prevention, (2006), available at http://www. cdc.gov/nchs/data/ad/ad376.pdf. 157. see generally sujit choudhry et al., specialty versus community hospitals: what role for the law?, healtii aff., web exclusive, aug. 9, 2005, at w361, (discussing the need to revisit con as a way to control costs associated with unnecessary growth in the specialty hospi­ tal industry). 158. the dirigo health act, me. rev. stat. ann, tit. 24 a, § 6901-6971 (2003). see also maine.gov., http://www.dirigohealth.maine.gov/dhspold.html (last visited apr. 20, 2008). 159. see john v. jacobi, consumer-directed health care and the chronically ill, 38 u. mich. j.l. reform 531, 537-38 (2005) (describing the mixed effects of certificate-of-need legis­ lation on controlling costs). 160. richard perez-pena, plan could close 20 or more new york hospitals, 318 indiana health law review [vol. 5:277 beds were not in use and noting the hemorrhaging of red ink by many underper­ forming hospitals, a commission appointed by then governor pataki stated that the fiscal stability of the health care industry required such actions.161 oppo­ nents argue the hospital closures will impede care for mostly poor individuals and would have a greater impact on smaller communities where the hospital serves as a major employer. 162 radical steps like the ones noted here may be seen in other states as they attempt to stretch medicaid dollars and weed out inefficient facilities that have failed to stay fiscally responsible and relevant. with a major shift of care from inpatient to outpatient services, the increase in specialty hospitals, the chal­ lenges of providing rural health care, and with the new advances in technology, the issue of how to strike a balance between controlled expansion, without im­ peding entrepreneurial enterprise and access to effective technology-driven treatments, will be challenging.163 with increased costs and the competition to secure aftluent areas that have health insurance coverage, the public and private sector must find common ground in being able to provide services that promote competition but also create an environment of responsible growth. 2. health provider shortage: the first stumbling block to meaningful re­ form finding properly trained health care professionals is an ongoing problem for most communities throughout the united states, and threatens the success of any health care reform proposal. predictions continue to indicate that short­ ages for nurses, physicians, pharmacists, and other health care technologists will continue for the next several years. 164 often the communities with the most serious shortages generally also experience greater rates of poverty and poorer health status. these communities increase overall health care costs as individuals tend not to seek health care until urgency strikes and then access care through hospital emergency departments which is the most expensive and least efficient manner to obtain care. as patients postpone care, simple health conditions that are easily treatable in early stages often proliferate into complex illnesses that require more expensive inpatient hospital care. further, with few­ er physicians entering primary care practice, the uninsured and underinsured are hindered from obtaining basic primary care services. as individuals remain without access to affordable basic primary care services, the current health sysnytimes.com, nov. 29, 2006, http://www.nytimes.com/2006111/29/nyregion/29hosp.html?ex= 1322456400&en=7c08722a4489a517 &ei=5088&partner=rssnyt&emc=rss (last visited apr. 26, 2008). 161. /d. 162. /d. 163. financing the furore, supra note 20, at 6-12. 164. american academy of family physicians, higher demand for family physicians bodes growth despite sluggish pay increases, annals off am. med. 89, 89-90 (2005). see also howards. berliner & eli ginzberg, why this hospital nursing shortage is different, 288 jama, 2742, 2742-44 (2002). 2008] the recent state rally for health care reform 319 tern will continue to function as a reactive model focused on treating the ad­ vanced stages of disease rather than utilizing early intervention strategies that lead to better outcomes that mitigate more costly care. medically underserved communities that suffer from health professional shortages tend to be concentrated in rural communities and inner city areas where there are increased numbers of economically disadvantaged individuals where the shortage of primary care providers and nurses is much more pro­ nounced. 165 the supply and distribution of health professionals varies greatly based on the various geographic, demographic, and socioeconomic factors. health professionals are more likely to be concentrated in affluent areas and less likely to be concentrated in areas where the population is less dense and areas where the population has higher proportions oflow income and racial and ethnic minorities.166 further, a landmark 2002, institute ofmedicine report on racial and ethnic disparities found that even among well-controlled studies "the vast majority of published research indicates that minorities are less likely than whites to receive needed services, including clinically necessary procedures, even after correcting for access-related factors, such as insurance status."167 with decreased access to care, ethnic populations suffer disproportionately from poorer health status and higher health care costs. 168 as part of reform efforts, many states have expanded the scope of practice for care provided by non-physician health care professionals by recognizing the value these providers will have in creating a more effective and efficient inter­ disciplinary health care delivery model. in these discussions, the role of nurse practitioners ("np") and physician assistants ("p a") have become more widely viewed as a viable, competent provider source for providing cost-effective health care services. both nps and pas have advanced clinical training that allows them the ability to practice in a wide variety of clinic settings but does so from different legal obligations defined under various state laws. for nps in 165. see denavas-waltet al., supra note 5, at 19-30. 166. see michael e. wade et al., influence of hometown on family physicians' choice to practice in rural settings, 39 family med. 248-54 (2007). 167. institute ofmedicine, unequal treatment: what health care system administrators need to know about racial and ethnic disparities in healthcare, (2002), available at http://www.iom.edu/object.file/master/14/973/disparitiesadmin8pg.pdf. 168. many minority groups simply do not have the same access to care as the general white population. for example: african americans are thirteen percent less likely to undergo coronary angioplasty and one-third less likely to undergo bypass surgery than are whites; among preschool children hospitalized for asthma, only seven percent ofblack and two percent ofhis­ panic children, compared with twenty-one percent of white children, are prescribed routine me­ dications to prevent future asthma-related hospitalizations; the length of time between an abnormal screening mammogram and the follow-up diagnostic test to determine whether a woman has breast cancer is more than twice as long in asian american, black, and hispanic women as in white women; african-americans with hiv infection are less likely to be on anti­ retroviral therapy, less likely to receive prophylaxis for pneumocystis pneumonia, and less likely to be receiving protease inhibitors than other persons with hiv. see agency for healthcare quality and research, addressing racial and ethnic disparities in health care, http://www.ahrq.gov/ researchldisparit.htm (last visited apr. 20, 2008). 320 indiana health law review [vol. 5:277 particular, many states allow for independent practice as their undergraduate nursing background and master's degree training fits well within several clini­ cal specialties including primary care-related areas. given the shortage of primary health providers in the state, future policy decisions should focus on expanding the scope of services and care that can be provided by non-physician providers who have the education, skill, and compe­ tence to provide such services. clinically, nps have demonstrated the ability to provide high quality care commiserate with their physician colleagues and are well positioned as a profession based in evidence-based research to work within a variety of settings as part of a valued care team which has already been dem­ onstrated in the medical home model.169 in order to expand access to primary care, nps and pas must have the ability to serve as primary care providers un­ der medicaid and other state health reform programs. nps and pas can help fill the gap created by the chronic shortage of primary care physicians that is foreseeable into the near future. 3. emergency department utilization rates over 4,000 emergency departments ("ed") in the u.s. have become the default primary care clinic for many of the forty-seven million uninsured. the number of uninsured visits to the ed is typically double that of the insured. 170 one report reveals that at least ten percent of all ed visits can be attributed to the uninsured. 171 on the inpatient side, the uninsured account for at least five percent to thirteen percent ofhospital discharges. identifying why individuals access eds is telling as to why there needs to be increased access to primary care for the uninsured. the centers for disease control ("cdc") released an ambulatory surgery utilization report that identified major areas of utilization for outpatient and ed care which includes the following list of visit types by percentage rate: 172 mental health-related, 7.6%; injury, poisoning, or adverse effects of medical treatment, 12.1 %; other acute or benign conditions, 16.6%; infectious conditions, 18.1%; preventive care, including check-ups, prenatal care and post-surgical care 25.2%; and chronic disease treatment, 29.4%. another key report by the institute of medicine studying ed overcrowding found the following: one in five patients were uninsured; ninety-one percent of surveyed eds reported overcrowding with forty percent stating this occurred daily; non-emergent patients were frequently crowding out emergent care pa169. mary mundinger et al., primary care outcomes in patients treated by nurse practi­ tioners or physicians: a randomized trial. 283 jama 59, 59-68 (2000) (demonstrating nps achieved clinical outcomes as good as or better than their physician colleagues). 170. catharine w. burt. linda f. mccaig, & elizabeth a. rechtsteiner, ambulatory medi­ cal care estimates for 2005, advancedatafromvitaland heal1hstatistics, ctr'sfor disease control & prevention, (june 2007), http://www.cdc.gov/nchs/data/ad/ad388.pdf. 171. catherine g. mclaughlin & karoline mortensen, who walks through the door? the effect of the uninsured on the hospital, 22 heal1haff. 143, 143-55 (2003). 172. see burt et al., supra note 170, at 2-4. 2008] the recent state rally for health care reform 321 tients who required immediate care; and ed patients tend to be older and sicker in need of more expensive work-ups. 173 tracking patient encounters across eds is an important indicator to demonstrate how individuals access emergent and non-emergent care and also serves as an important measurement of how specific ed utilization rates compare with the primary care system. this type of information will be critical to analyzing geographical and socioeconomic factors that drive non-emergent visits to eds. while the burden of caring for the uninsured is shared by many providers, hospitals, (for-profit, nonprofit, and safety net hospitals) are often hardest hit by being forced to provide uncompensated care. under the emergency medical treatment and active labor act ("emtala"), any hospital with an emer­ gency room must at minimum screen, and if necessary, stabilize anyone pre­ senting to the ed regardless of ability to pay. 174 too often, hospital eds become crowded with people in need of non-emergent primary care but never­ theless must be cared for under emt ala. as a result, the amount of uncom­ pensated and charity care provided by hospitals has increased dramatically due to the uninsured. charity care has become a popular topic for the fact that more uncompensated care is being provided beyond the levels many nonprofit hospi­ tals, who are required to provide some level of free care, can maintain. as hos­ pitals have been forced to provide more charity care, there has been a "spillover effect" to the community as providers ultimately earn less revenue and insured individuals pick up the tab in either increased health insurance premiums or in increased taxes often directed to pay to cover care for the uninsured. 175 in addi­ tion, hospitals are facing increased competition and more narrow margins in a market increasingly filled with competition with large physician groups and physician-owned specialty hospitals. once lucrative service lines that were his­ torically in a hospital's control and that were used to offset losses incurred in delivering care to the uninsured and in less lucrative areas have been carved out of the hospital revenue stream.176 in the wake of increased utilization, some hospitals have adjusted to the increased use of their eds for non-emergent services by setting up "fast-track" clinics or opening urgent care wings adjacent to their eds. these clinics often provide care to the insured and uninsured alike as it presents the only conven­ ient alternative for many who need care during after-work hours or for those without a consistent primary care home. while some hospitals with a higher insured base may realize increased payment with higher ed utilization rates, eds however, are more costly and do not present the most economical model to 173. inst. of med., hospital-based emergency care: at the breaking point (the national academies press) (2006). 174. see 42 § 1395dd; see also 42 c.f.r 489.24. 175. mark v. pauly & jose a. pagan, spillovers and vulnerability: the case of commu­ nity uninsurance, 26 healthaff. 1304, 1304-14 (2007). 176. charles n. kahn, intolerable risk, irreparable harm: the legacy of physician­ owned specialty hospitals, 25 healthaff. 130, 130-33 (2006). 322 indiana health law review [vol. 5:277 provide primary care. health policy efforts should examine ed utilization data to devise new strategies to channel individuals to less costly primary care. c. bringing back the integrated delivery system: can it still work? one critical problem facing the current health delivery system is the fact that many providers, insurers, hospitals, and vendors are providing services in an uncoordinated manner in various "silos of care." this development has led to needless duplication and waste, often to the detriment of patients. this fragmentation in care has been brought on by historical changes in the health discussed above with the onset of the managed care and has been exacerbated by payment structures that reward institutions with increased payment for high­ end technological and specialty care services.177 historically, there has been little effort between providers or health care systems to share patient informa­ tion or offer strategies to change provider behavior that could control costs and increase efficiency. 178 still today, market forces have largely splintered rela­ tionships between hospitals and physicians, creating perverse incentives for competition that in many cases have led to an inadvertent "race to the bottom." today's market continues to uphold delivery structures and payment method­ ologies that promote higher cost episodic care and expansion of high-end prac­ tice lines that optimize hospital and provider margins rather than encourage the most efficient delivery of care. 1. past attempts in developing an integrated delivery system the integrated delivery system ("ids") became a model of health care de­ livery that emerged from of the managed care movement. 179 during the period of reform of the 1980's and 1990's, with the managed care expansion and the possibility of health reform brought about under president bill clinton, stake­ holders began to re-examine their various relationships and service lines. as a result, several expansions and contractions occurred among many of the among physician groups, hospitals, and insurance companies which led to mergers and joint ventures designed to increase coordination of services and enhance econ­ omies of scale that made providers better aligned to compete for managed care contracts. 180 the movement caused many health care entities to more intensive­ ly control patient care management by engaging in what has been termed "hori­ zontal integration" and "vertical integration."181 horizontal integration largely occurred with mergers and alliances between hospitals which led to the forma177. halvorson, supra note 145, at 12-30. 178. id.at210-18. 179. furrow et al., supra note 2, at 535. 180. furrow et al., supra note 2, at 535, 541. 181. lawton r. bums & mark v. pauly, integrated delivery networks: a detour on the road to integrated health care?, 21 health aff. 128, 128-43 (2002). 2008] the recent state rally for health care reform 323 tion of local networks and multi-hospital systems. horizontal integration also occurred among independent and smaller physician groups which led to the creation of large physician groups or partnerships. vertical integration took place with hospitals purchasing physician practices or creating alliances with physician groups which led to the upsurge in physician-hospital organizations and health maintenance organizations.182 the health care system that emerged from this provider shift was one of complicated relationships between physicians, hospitals, and payers arranged under complex legal contracts and arrangements where patient care, treatment goals, and control over economic incentives were not always shared between and within these entities. 183 what emerged were insurers, physicians, and hos­ pitals all competing to establish their prominence in the marketplace. for in­ stance, some hospitals systems became completely vertically integrated by having multiple hospitals in a specific geographic area but also owned multiple specialty and primary physician practices, outpatient clinics offices, and ambu­ latory surgery centers. these systems also by virtue of their geographic size also offered their own provider health plans to employers. further, in order to remain relevant, physicians often partnered with these larger systems in more loosely affiliated contractual partnerships where the larger entity shared more accountability and risk. for example, a hospital or insurer would often pur­ chase a physician's existing infrastructure including files, equipment, and pay for office staff, but the physician would then work for the system as an inde­ pendent contractor. because hospitals and insurers at the time of this shift typi­ cally had deeper pockets to reorganize a new business model in the marketplace, there was a rush to try and capture large market shares in order to be more attractive to employers purchasing managed care insurance plans. as a result physicians were often left in the middle to try and bargain for the best deal between insurers and hospitals. many agree that the integrated delivery system that emerged from this re-alignment ultimately failed to enhance patient care or control costs. many reasons are cited, a few of which include: hospitals moved to fast to restructure the system; hospitals spent too much money to ac­ quire physician practices; hospital-based hmos did not have the expertise to accurately pool risk and meet service demands; a recurring inability to coordi­ nate physician and hospital goals; and consumer backlash against restrictions on care.184 while past attempts at implementing integrated delivery models were met with mixed results as a result of the managed care changes, there is growing and renewed support that providing quality, cost-effective care in the future will only be achieved with some level of coordination and integration among all stakeholders that comprise the health care system. 185 although many would 182. furrow et al., supra note 2, at 535. 183. hallet al., supra note 15, at 1066-69. 184. bums & pauly, supra note 181, at 132-36. 185. !d. 324 indiana health law review [vol. 5:277 argue the united states has the biggest and best health care system in the world, these facts have often not correlated the best care as the united states consis­ tently scores poorly in major health indicators.186 the future of health care must be driven by efficient models of patient care that encourage coordination and integration. one such example can be found already operating within the federal governmentthe veteran's administration ("va") hospital system. among the best health system models typically recognized, the va sys­ tem represents a change in thinking and practice that has been acknowledged by many researchers as a health care system that is moving in the right direction.187 va currently cares for over 5.3 million veterans at 1400 sites in every state which is divided into twenty-two care networks serving as the largest public integrated delivery system in the u.s. 188 although va has room to improve with the execution of services across all of its hospital and clinic sites, recent movements to make the system more efficient have garnered the attention of other health systems. va' s re-structuring success has largely been driven by the implementation of it and the expansion of uniform medical records. for example, va now implements a system whereby a va patient from california can walk into the va hospital in indiana and have their records immediately at the fingertips of a health care provider. va has also utilized this technology at the bedside to increase collaboration, decrease mistakes, and enhance commu­ nication between providers. va was one of the first systems to store all medi­ cal-related data which now contains over 779 million clinical documents, 1.5 billion orders, and over 425 million images. va has used this innovation in technology to perform better than other private entities. 189 further, the v a's cost per patient has not increased over the past ten years remaining steady at about $5000, while medical care for families in the private sector has jumped about forty percent. 190 in addition, the va, by virtue of being a government funded agency, has special relationships and abil­ ity to integrate innovative practices on a large scale. one area where this has proven beneficial is in the purchasing of medications. congress has given the secretary of the va the ability to negotiate directly with drug companies for pricing on medications which has allowed veterans to purchase medications at a much lower cost than private insurers or medicare recipients. the va system 186. cathy schoen et al., u.s. health system performance: a national scorecard, 25 healtii aff. w457, w457-75 (2006); see also elizabeth a. mcglynn et al., the quality of health care delivered to adults in the united states, 348 new eng. j. of med. 2635, 2635-45 (2003). 187. steven asch et al., comparison of quality of care for patients in the veteran's health administration and patients in a national sample, 141 annals of internal med. 938, 942-45 (2004) (comparing care of va patients to others and noting that the va system does a much better job of coordinating care across a complex national institution). 188. joel kupersmith eta!., advancing evidence-based care for diabetes: lessons from the veterans health administration, 26 health aff. w156, w 156-68 (2007). 189. see douglas waller, vetting the va, aarp bulletin, may 2007, http://www.aarp. orglbulletinlbulletin/yourhealth/vetting_ va.html (last visited apr. 26, 2008). 190. !d. 2008] the recent state rally for health care reform 325 has become a model of quality and efficiency by consistently examining and comparing the best practices and guidelines in clinical practice across all of their hospitals in the country, providing caregivers the information they need to provide high-level care. the va system serves as an excellent model for both state and federal governments as to how national policies can be successfully formulated across large and complex health care delivery systems. 2. primary care as the center piece for integration with reform efforts underway around the country, many are focused on increasing access through a multi-pronged approach ranging from insurance subsidies, to increased use of information technology, to increased coordination among providers, and appropriate use ofhealth services. many of these efforts could be organized as part of an integrated delivery model where individuals are given access to basic primary health care. a key part missing from the cur­ rent delivery system equation is the lack of access to consistent, basic primary care services. if state legislatures want to get the most from their tax payer dol­ lars, they would be well served to re-design health reform efforts around a new delivery model focused on primary care. there is a broad consensus that access to timely, primary and preventive health care services results in lower health care costs and better health outcomes than uncoordinated, delayed care. 191 a study of vulnerable populations docu­ mented the link between shortages of primary care providers and preventable hospitalizations. for example, medicare beneficiaries in fair or poor health are more likely to experience a potentially preventable hospitalization ifthey live in a county designated as a primary care shortage area. 192 in fact, even when tak­ ing into account the number of specialists versus primary care providers in a particular area, increasing the supply of specialists does not improve the united states' position in relation to relative health as compared to other industrialized countries as increased specialist supply has been shown to promote greater dis­ parities in health status and outcomes. 193 a. the patient-centered primary care "home" concept much of the reform efforts now being discussed at the state level have in­ stituted a renewed focus on coordination of all care through primary care model of care. engaging individuals in a consistent, trusting manner where a team of providers are competent and prepared to provide holistic, culturally sensitive, 191. see michael l. parchman & steven d. cullers., preventable hospitalizations in primary care shortage areas: an analysis of vulnerable medicare beneficiaries, 8 archives of family med. 487,487-91 (1999). 192. jd. 193. barbara starfield et al, the effects of specialist supply on populations' health: as­ sessing the evidence, health aff. w95, w95-l 07 (2005). 326 indiana health law review [vol. 5:277 and community-specific care must be the cornerstone of any new paradigm of care. while no one primary care model perfectly embodies this approach, there are current models and common themes that are beginning to take shape at the national level. one of the more interesting concepts to resurface is the "patient­ centered medical home." the concept of providing patients with a consistent primary care provider is not a new concept given the recent era of "gatekeep­ ers" that evolved with managed care. there are additional historic roots for creating primary care "homes" for patients as the "medical home" concept has used for nearly four decades and can be traced back to efforts by the american academy ofpediatrics which began modeling a clinic program designed to care for children with special needs.194 recently, there has been a new push to es­ tablish what is being called the "medical home"195 and "coordinated primary care. "196 this contemporary model no longer focuses exclusively on the pediat­ ric population as noted above, but is now being re-visited as a new model for the general primary care for the entire u.s. population. as it now stands, there is no one specific model that is the recognized "gold standard," but rather the current care home discussions are based in over-arching principles. there are, however, several pilot studies and new programs under way as part of the movement towards a medical home model. 197 slowly, there are common a ttributes emerging that appear to be moving in sync with the health reform discussions about the need for increased access to primary care. many of the major health profession organizations including, the american academy of family physicians, american academy of pediatrics, the american college of physicians, and the american academy of nurse practitioners have revisited how the medical home model should be conceptualized in this new era of health care restructuring. from these proposals general concepts from the pri­ mary care home model include: 1) providing care beyond chronic disease man­ agement with a focus towards preventive care targeting health promotion and maintenance; 2) providing care through a collaborative team model including nurse practitioners, pharmacists, public health nurses, social workers, and phy­ sicians; 3) the primary care home will be the coordinating mechanism for all care with specialty providers, therapists, and hospital services; 4) care should be 194. see american academy of pediatrics, http://www.medicalhomeinfo.org/ (last visited apr. 20, 2008). 195. see karen davis & steve schoenbaum, medical homes could improve care for all, the commonwealth fund, july 20, 2007, http://www.commonwealthfund.org/aboutus/ aboutus_show.htm?doc_id=510655; see also medical home gains prominence with aafp oversight, annals of fam. med., 6:90-91 (2008), http://www.annfammed.org/cgi/ content/full/6/l/90 (last visited apr. 20, 2008). 196. am. acad. of nurse practitioners, nurse practitioners: promoting access to coordinated primary care, (dec. 5, 2007) (on file with author). 197. see bridges to excellence launches medical home program, jan. 31, 2008, http://www.bridgestoexcellence.org/content/contentdisplay.aspx?contentld= 119 (last visited apr. 20, 2008); see also the commonwealth fund, evaluating a medical home in two health plans, dec. 2007, http://www.commonwealthfund.org/grants/grants_show.htm?doc_id=584761. (last visited apr. 26, 2008). 2008] the recent state rally for health care reform 327 maximized through a continuous care relationship, not simply episodic care; 5) care may be provided in a variety of settings where the use of advanced tech­ nology, emr, and tele-health should be standard; 6) linking patients to com­ munity sources to address mental health, addiction, and other basic needs such as food, shelter, and medications; and 7) enhancing access through extended hours and open access scheduling. while the medical home is appealing for many reasons, the application may be challenging in many cases as there are not enough primary care physi­ cians to support medical homes needed to meet the demand in care. further, as noted earlier, the distribution of providers reveals many physicians are clustered around major cities with a disproportionate distribution number not choosing to practice in poorer urban and rural settings which may hinder proper coverage. also creating problems are the continuing issues associated with reimbursement and coordination of care between specialties and other health care professionals such as social workers, health educators, and therapists. on the reimbursement side, many physicians and other providers feel the current health care system is improperly incentivized. for example, there is little to no reimbursement for activities geared towards health prevention and promotion. many argue that the current reimbursement model incents performing procedures and racking up large volumes for episodic care for common infections and lab draws. provid­ ers argue that until the reimbursement system is properly aligned towards health promotion and prevention, it will be difficult to properly engage their patients and continue to remain financially sound on the clinical side of their practice. b. community care of north carolina: a successful primary care model while many states have addressed access to primary care, north carolina has been developing a model that holds promise for application with the unin­ sured and serves as a model for expanding a state-wide system of care. north carolina's community care ofnorth carolina ("ccnc") began as "access" in 1991 which evolved from a demonstration program in 1998. 198 the ccnc program evolved from the previous case management program that was part of a state-wide effort to better manage the care provided to medicaid enrollees. over the past several years, the ccnc program has garnered national attention as a provider-led alternative that has been able to increase the quality of care while also controlling costs. the ccnc program is organized around the fol­ lowing principles: 1) ownership is vested with community participants; 2) roles and responsibilities of the participants (both government and providers) are clearly defined; 3) accountability is clear and measured; 4) in-depth technologi198. see community care ofnorth carolina, http://www.communitycarenc.corn! (last visited apr. 26, 2008). 328 indiana health law review [vol. 5:277 cal assistance is provided by the state on a continuous basis; and 5) meeting community needs is the focus of all activities. 199 during its time in existence, the ccnc program has placed an emphasis on quality outcomes, best practices, and has made providers accountable for the patients they care for. for example, the cncc program has required care ini­ tiatives that measure and provide treatment programs for asthma, copd, con­ gestive heart failure, diabetes, in addition to tracking of emergency department and medication utilization and special tracking of high-cost patients. the pro­ gram has the evidence to support that this unique community-based network is achieving results. one study done by the mercer human resource consulting group found that the program in fiscal year 2006 saved $154-170 million.200 currently the ccnc program has fourteen networks with over 3,000 phy­ sicians that serve 785,000 patients.201 all local networks operate as 501(c)(3) non-profit organizations that at minimum, include area primary care providers, a hospital, the county department of social services (medicaid) office, and the county health department. 202 each network is required to assess, with the help of the state, the specific needs of the population they serve and then develop subsequent treatment standards to best meet the needs of the population with special attention placed on high-cost individuals. each network elects a physi­ cian to serve as the clinical director who serves on statewide board of directors responsible for overseeing the direction ofthe system's programs. moreover, other key professionals play a key role in the care model which includes case managers, quality improvement champions, and network coordinators. al­ though financing is run through the medicaid program, ccnc, in addition to the payment of fee-for-service, pays physicians a coordination fee of$3.00 per patient, per month. physicians in the state, however, remain frustrated that the payment fee schedule is not incentivized to promote more primary care-related activities. 203 199. stephen wilhide & tim henderson, community care of north carolina: a provider­ led strategy for delivering cost-effective primary care to medicaid beneficiaries, available at http://www.nahit.org/cmslindex.php?option=com _ docman&task=doc _ view&gid= i 07 &itemid= 197 (last visited apr. 26, 2008). 200. mercer report, ccnc/access cost savings for fiscal years 2005,2006, available at http://www.communitycarenc.com/pdfdocs/mercer%20sfy05 _ 06.pdf. 201. community care at a glance, jan. 2008, http://www.communitycarenc.com/ pdfdocs/ccnc%20at"/o20a%20glance.pdf. 202. wilhide & henderson, supra note 199, at 5-7. 203. james arvantes, medical homes, physician-led networks can improve care, cut costs, aafp.org, mar. 6, 2007, http://www.aafp.org/online/enlhome/publications/news/ news-now/govemment-medicine/20070306northcarolina.html (last visited apr. 20, 2008). 2008) the recent state rally for health care reform 329 d. federal action that could impact state initiatives 1. the continued erisa problem at the heart of reform process lies the complexity of the federal-state rela­ tionship that is replete with a web of laws and invites many potential reform roadblocks. as demonstrated previously with the maryland "wal-mart case," conflict with the federal erisa law may preempt the ability of future state health reform legislation to regulate private health insurers.204 historically, the erisa language has been broadly interpreted by the supreme court to allow employers who are self-insured to be bound only by the federal erisa law which preempts most state regulation. while erisa does not preempt states from passing laws that mandate certain benefits be offered in the state or to raise costs, the erisa statute has limited most states' abilities to regulate pri­ vate employer's conduct when administering their self-insured plan.205 many would argue the vague and contested "related to" language of erisa has cre­ ated an environment where many employers who qualify as self-insured entities under the erisa statute, enjoy a subset of protections for employers, providers, and insurers that has been used to circumvent state regulation under the guise of erisa preemption. 206 other cases in addition to the wal-mart case, have surfaced in the past few months which reveal the courts are continuing to side with upholding erisa preemption where pay-or-play mandates are issued. in two federal court cases, the courts have held that erisa pre-empts state laws that created a pay-or-play schemes similar to the one noted in fielder. in retail industry leaders v. suffolk county the federal district court for the eastern district of new york held that that the city ordinance that required certain large retail stores with specific revenue or inventory space to ensure certain employee health care costs were in line with the county's uninsured workers system, was erisa preempted. 207 the court finding the suffolk country plan similar to maryland's, followed the fourth circuit's logic in fielder and determined that the mandatory payment required whether it be through the erisa plan, a health savings account, or other contribution option, created a conflict for em­ ployer's not allowed under erisa. similarly, in golden gate restaurant as­ sociation v. city and county san francisco, the court held that a san francisco city ordinance that would have required all city firms to spend a specified 204. kinney,supranote99, at917-18. 205. see new york conference ofblue cross & blue shield plans v. traveler's ins. co., 514 u.s. 645 (1995); metro. life ins. co. v. massachusetts, 471 us. 724,739-40 (1985). see also pilot life ins. v. dedeaux, 481 u.s. 41,48 (1987). 206. kinney, supra note 99, at 924-27. 207. retail indus. leaders v. suffolk county, no. 06-cv-00531 (e.d. n.y. july 14, 2007). 330 indiana health law review [vol. 5:277 amount per hour, per employee to cover some health services or be required top pay the city an amount that would fund a public health insurance subsidy for the uninsured, was erisa preempted. 208 the erisa conundrum illustrates an area where the federal government could work with states by revisiting the specific aspect of the erisa statute that prevents states from implementing innovative changes. at this point in the evolution of health reform, states are in the best position to re-tool the health care infrastructure and will need the benefit of federal support with regulatory issues such as erisa. with congress unwilling to devise more well-defined boundaries surrounding the erisa preemption issues as it pertains to state reg­ ulation of employers and insurers, 209 others have advised on ways to structure the reform efforts that may face erisa challenges. for example, patricia but­ ler has listed a series of considerations the courts may find favorable to uphold a state initiative without finding erisa preemption.210 for example, butler recommends states consider taking the following steps when designing an em­ ployer pay-or-play mandate: 1) make sure the plan does not explicitly refer to erisa; 2) sponsors of the legislation should stay neutral as to whether employ­ ers are forced to pay the assessment or provide coverage; 3) any tax credit pro­ vided for covering employees can be applied to any health spending not just spending on traditional health plans; 4) the credit is not premised on the em­ ployer meeting the structural requirement of the law such as premium sharing; 5) if the employer pays the assessment (in lieu of providing employee cover­ age), this will not prevent the employee from participating in the state program; and 6) it may be better to call any assessment a tax versus a fee in order to bring the payment under the state's authority. 211 although there is no guarantee that the courts will deviate from the erisa stance discussed in the case above, with more health reform statutes coming on line, the court system may start uphold­ ing statutes as a signal to congress to take action or to allow states increased flexibility to handle the health care issue. the courts may also uphold state ac­ tions to avoid conflicting federalism issues that were not fully considered with respect to health care coverage when erisa was created. 212 208. golden gate restaurant ass'n v. city and county of san francisco, no. cv-0606997-jsw (n.d. cal. december 26, 2007) {the city was successfully able to persuade the ninth circuit court of appeals to issue a stay of the district court decision pending the out­ come of the appeal). 209. janak. strain & eleanor d. kinney, the road paved with good intentions: prob­ lems and potentia/for employer-sponsored health insurance under erisa, 31 loy. u. chi. l.j. 29, 55, 67 (explaining how erisa could be reformed to promote state regulation while still honoring the spirit of erisa to protect employee benefit plans). 210. patricia a. butler, erisa implications for state health care access initiatives: im­ pact of the maryland fair share act" court decision, national academy for state health pol­ icy, nov. (2006). 211. id. at 11. 212. id. 2008] the recent state rally for health care reform 331 2. issues of federalism another wrinkle to add to the already complex federal-state relationship is the issue of the boundaries of federalism. a series of supreme court cases have recently limited the power of congress via the commerce clause to pass legislation that mandates state regulation.213 under these supreme court rul­ ings, congress may be hampered in passing legislation that would promote con­ tinued state innovation in the health care arena. generally, it has been recognized that states retain the police power to control and provide for the health of its citizens.214 with renewed reform ef­ forts in play, concerns have arisen over whether a uniform federal health care system or other federal health care plan will erode state autonomy to exercise its well recognized police power. while these concerns are legitimate, federal ac­ tion should not be restricted in such a manner that the federal government be­ comes limited in its ability to participate in the process by enacting legislative solutions to this complex crisis that affects the entire nation. the health care crisis runs deeper than each individual state's particular local, cultural, reli­ gious, or geographic needs. clearly, there are issues of state control as demon­ strated with assisted suicide and medical marijuana reform that may be better left to the states, however, the issue of affordability and access to basic health services goes to the heart of the united states economy and general welfare. further, the federal government has been able to successfully pass legislation to solve complex social problems that in the past that has traditionally been left to the states. some examples include federal legislation to handle the education crisis in the no child left behind act, racial inequality in the civil rights act, and the racketeer influenced and corrupt organizations act as an example of containing the effects of national organized crime. 215 these legislative acts were passed to create accountability for underperforming state programs or pol­ icies that presented unique issues important to the nation as a whole. whatever concerns there may be regarding a federal monopoly of the health care system, ultimately the power of the people to vote and congress' "power of the purse"216 provide the political ammunition and spending power 213. see seminole tribe v. florida, 517 u.s. 44, 56-57 (1996); u.s. v. lopez, 514 u.s. 549, 566-67 (1995); u.s. v morrison, 529 u.s. 598 (2000) (each case redefining the ability of congress to require state action under the power of the commerce clause). 214. u.s. const. amend. x, ("[ t]he powers not delegated to the united states by the con­ stitution, nor prohibited by it to the states, are reserved to the states respectively, or to the peo­ ple"). 215. see no child left behind act of2001, pub. l. no. 107-110, 115 stat. 1425 (2002) (codified primarily in scattered sections of20 u.s.c.); civil rights act of1964, pub. l. no. 88352,78 stat. 241 (1964); racketeer influenced and corrupt organizations act ("rico") (pub. l. 91-452,84 stat. 941 (1970). 216. marmor & oberlander, supra note 1, at 217-219 (ultimately meaningful health care reform will require the federal government to coalesce a unified plan that coordinates a certain level of service and funding). but cf tammy murray, state innovation in health care: con­ gress' broad spending power under a national health care system will stifle state laborato332 indiana health law review [vol. 5:277 needed to pass reform without unconstitutionally trumping state rights. the health care crisis is too big for states to handle alone; when the country falls deeper into a crisis that expands beyond a state or region, federal action is often required. while the judicial branch will likely serve as a check on reform is­ sues, previous decisions thus far, as demonstrated in cases such as seminole tribe v. florida and u.s. v. lopez, were decided on narrow grounds geared largely as part of a push-back from the courts against an over-reaching legisla­ tive branch. although the legislature must respect the republic's boundaries when enacting legislation, the court likewise cannot legislate or abuse its au­ thority to haphazardly limit legislative reform. the issue ofhealth care presents unique problems that will require a cooperative federal-state relationship where all reasonable federal efforts can be given the necessary opportunity to em­ power states to deal head-on with the health care crisis. already the medicaid and medicare programs are examples of federal to state partnerships that repre­ sent health care dollars being used synergistically to promote health care access and affordability. there is no reason to believe that this same type of state in­ novation and experimentation will not occur in conjunction with the federal government to the detriment of state autonomy. while turf wars between the state and federal government are likely to continue in the face of health care reform, this is nothing new and represents the check built into the system that has always served to outline the legislative boundaries. simply leaving the states alone to determine their own local "an­ swer" creates the same problems where state reform could create economic dis­ harmony leaving one state economically disadvantaged against another. as demonstrated in many of the previous congressional acts, the federal govern­ ment has an interest in national uniformity. without question a balance must be struck where the boundaries of federalism are respected but where innovation is not so stymied that meaningful reforms engineered at the national level are nev­ er given a chance. the current health care system is an amalgamation of hap­ penstance policy mired in both federal and state legislation driven largely by medicare and medicaid laws passed at the federallevel.217 while the supreme court may be moving towards reaffirming the protection of state autonomy, the power of the people in the political process to demand health care reform should be the guiding principle and foundation for change. the complex process of reforming health care should not be legislated from the supreme court bench. 3. prescription drog price negotiations negotiation of prescription medication prices is another area where feder­ al action can have a meaningful impact on making the health care system more ries of democracy, ind. healtii l. rev. 263,283-86 (2006) (arguing that state should control most areas of health reform). 217. eleanor d. kinney & william m. sage, resolving medical malpractice claims in the medicare program: can it be done?, 12 conn. ins. l.j. 77, 81-2 (2005). 2008] the recent state rally for health care reform 333 cost-effective and efficient for states. as the medicare modernization act cur­ rently stands, part d drug prices are not set in a prospective payment system by cms.218 when given the choice to use a centralized approach that would allow the secretary of health and human service to directly negotiate with the phar­ maceutical companies, congress elected to instead allow a third party, phar­ macy benefit managers ("pbm"), to handle price negotiations.219 while some argue pbms have incentives to keep drug prices low, the fact that the secretary of cms cannot negotiate directly (as the secretary ofv a currently can do) cer­ tainly invites questions as to the undue influence the pharmaceutical insurance industry has on keeping prices inflated.220 while pharmacy costs account for eleven percent of all personal health care spending and with the pharmaceutical industry profits and advertising budgets soaring, the american people deserve a fair shake in being able to have access to affordable drugs.221 the democratic controlled congress has tried challenging the mma by passing legislation that would allow the federal government to negotiate better drug prices but has thus far failed. 222 vii. conclusion-are we there yet? like kids in the back seat of a car waiting to arrive at the long awaited destination the question of, "are we there yet?" appears more appropriate than ever with respect to health care reform. the current state actions to attempt to increase coverage may be the tipping point for jumpstarting significant reform action at the federal level regardless of where reform settles in, with the baby boomer population retiring, the number of uninsured continuing to grow, and with uncontrollable health costs, health care reform will remain a top national issue for some time to come. furthermore, as the global economy continues its rapid expansion, the united states must remain relevant and competitive by keeping pace with its industrialized peers by sustaining a healthy work force and maintaining control on health care costs. the united states needs to send 218. susan addler channick, the medicare prescription drug, improvement, and mod­ emizationacto/2003: will it be good medicine for u.s. health policy?, 14 elder l.j. 237, 254-55 (2006). 219. !d. 220. !d. 221. the he"nry j. kaiser f am. found., impact of direct-to-consumer advertising on prescription drug spending, june 2003, available at http://www.kff.orglrxdrugs/upload/ impact-of-direct-to-consumer-advertising-on-prescription-drug-spending-summary-of­ findings.pdf(reporting that spending by the pharmaceutical industry increased from $9.2 billion in 1996 to $19.1 billion in 2001 ). 222. robert pear, bill to let medicare negotiate drug prices is blocked, nytjmes.com, apr. 18,2007, http://www.nytimes.com/2007/04/18/washington118cnd-medicare.html?hp (last visited apr. 26, 2008); see also medicare prescription drug savings and choice act of2007, s. 2219, 11 oth con g. (1st sess. 2007) (legislation re-introduced october 23, 2007, by illinois sen­ ator dick durbin to allow medicare to negotiate drug prices among other provisions being pro­ posed). 334 indiana health law review [vol. 5:277 foreign investors reassuring signals that doing business in the united states will not lead to profit losses due to out-of-control health care costs. also key to driving the entire process forward will be the "health" and strength of the relationship that exists between the state and federal government regardless of whether or not state plans continue to proliferate. 223 if the federal government decides to move towards a more centralized health care system, there will be many challenges given the various geographical constraints and population differences that exist from state to state. hopefully, however, after the current wave of state experimentation is evaluated, there will be many com­ ponents (as noted above) that will be worthy of adopting at the national level. already, the va system and medicare and medicaid programs represent suc­ cessful benchmarks that prove a national strategy to manage health care is pos­ sible. further, as barack obama and hillary clinton move towards the presi­ dential nomination, it is clear that health reform under their leadership will be an important part of their administration's objectives if elected. fortunately, senators obama and clinton have helped to renew the health care debate and keep this important topic in the spotlight of important national issues as they campaign in this time of economic distress and war. a. reforming the collective american health care psyche all stakeholders involved in the reform process will have to dig deep into the american subconscious and psyche to find deeper answers needed to resur­ rect a new health care system. in examining this complex environment where health care interactions take place, hidden is a very unique endeavor with val­ ues driven by a personal, cultural, and historical context that will require a nov­ el approach and deep understanding to define and redefine what it means to be "healthy." further, because health care is not an exacting business, like making cars or other products, we must appreciate the problems that we now face in providing care will never be made perfect in a free market system. there will always be a group that cannot participate in a market health care economy and there will always be market externalities that will require unique paradigms of care that fall out of even non-traditional business models. current business stakeholders, such as third-party payers, while not in jeopardy, will need to rad­ ically redesign and perhaps even realize their model is no longer relevant, effi­ cient, or the right answer to serve the country's future health care needs. the entire country will need to accept that a collective attitude adjustment is mandatory for all citizens and providers. for many health care providers, frustration continues to grow over the recurring chronic health problems that arise from lack of preventive care, obesity, sedentary lifestyles, and the abuse of tobacco products, drugs, and alcohol. while no one would advocate an ab223. kinney, supra note 99, at 911. 2008] the recent state rally for health care reform 335 olishment of the right to privacy, or would warrant severe restrictions on per­ sonal choice, the reach of public health and the burden to bear the costs of cer­ tain lifestyle choices must be addressed head-on. in doing so, a new era of ethical challenges will be ushered in. citizens will no longer be immune from the costs associated with their unhealthy or risky health behaviors. unhealthy behaviors will need to be confronted and citizens must be made to understand that their unhealthy actions are directly connected to not only their personal welfare, but the overall health of their neighborhood, city, state, and nation. a radical new accountability and lifestyle management mentality must take hold in order to change the way the health care system is utilized and engaged by individuals. likewise, health care providers must recognize that at the point of care, they no longer have exclusive autonomy for their patient's care nor do they re­ serve a carte blanche menu from which to purchase any unchecked health care service they desire for their patients. health providers at every level, however, must be integrated into the decision-making process and must be empowered to create an environment of health care that is cost effective, efficient and medi­ cally sound. while programs such as "pay for performance" hold some prom­ ise for containing costs, a more evidence-based approach to health care that coordinates health services aligned with national goals and standards of care must be integrated into the provider's office, but mindful that medicine is as much an art as a science, and cannot be administered in a one-size-fits-all man­ ner. without question, the quality, integration, and collaboration that must take place can only be done through the enhanced use of it. while the needed transformation may be a decade away, common databases and creative use of computer products and other products such as cell phones need to be woven as quickly as possible into the care delivery process. the hot-button issue of transparency will also continue to be a major part of the discussions in analyzing the ways in which consumers will be asked to participate in and navigate the health care system. many advocates are pushing for mandatory reporting by hospitals and other health care service providers in order to level with health care consumers about their actual costs, rates of pro­ cedure success, and morbidity and mortality outcomes. with this new era of reporting around the comer, this certainly begs the question of whether health care consumers are really and truly equipped to interpret what can be very com­ plicated language and statistics and whether or not they can actually use the information to make an "informed decision" about their care. further, the self­ reporting of health care organizations will also be subject to scrutiny. if the information health care organizations provide proves to be self-selected snip­ pets leading to untrustworthy data, the public movement towards an environ­ ment where pricing is more "clear" will only create further confusion and acrimony. demanding transparency from private and public institutions is a critical piece of reform that must be implemented in order to create a health care market more understandable to the average citizen that will promote trust in the process as well as increased efficiency of the system. 336 indiana health law review [vol. 5:277 b. we can no longer wait although the united states supreme court has not recognized health care as a right defined in the united states constitution,224 support for constitutional amendments at the state level mandating health care for all citizens is growing and poised to become reality. creating a system where universal coverage is standard for all citizens in one of the wealthiest countries in the world should be very achievable given the united states has the most advanced health care sys­ tem in the world. it is likely the incremental steps currently taking place in the states, will play out over the next few years creating a clearer picture of what the best model of care may hold for a nationalized plan. with the 2008 election process already well under way, there is a strong possibility that a change in the presidency will establish a bully pulpit from which the next president will lead the charge for meaningful reform. while the next president will want to avoid the mistakes of previous administrations, if they can construct a plan that can be easily articulated to constituents and can then develop a critical mass of support in congress, success may follow. in the meantime, states need to continue to move forward with plans that increase access to care and services for the forty­ seven million uninsured. regardless of the rate or type of change, all reason­ able plans should be embraced as the status quo will only continue to hinder the united states. the united states can no longer continue to pay bentley prices for care only to receive pinto-like quality in return. some may argue that health care reform is too expensive, but if we remain in the same rut, we will continue to pay for double-digit increases in health care that merely cost-shifts from one group to another while the quality of care will continue to languish. so the an­ swer to the question of"are we there yet?" is a resounding "yes!" the time has come to get to work to ensure health care is affordable and accessible to all american citizens, otherwise the health care system will remain lost in a sea of unaccountability and expensive mediocrity. at this time, state reform is the best hope for creating alternative solutions and the political will necessary to push health reform forward to the federal stage. the federal government should listen, learn from, and support these processes so that an eventual na­ tional plan can come about sooner rather than later. 224. harris v. mcrae, 448 u.s. 297,311,318 (1980) (concludingthattitlexixdoesnot require states participating in medicaid to pay for medical services for which federal reim­ bursement is unavailable); maher v. roe, 432 u.s. 464, 469 (1977) (''the constitution imposes no obligation on the states to pay the pregnancy-related medical expenses of indigent women, or indeed to pay any of the medical expenses of indigents.''). microsoft word 1-masthead vol. viii.doc stem cell based treatments and novel considerations for conscience clause legislation lucas mlsna* i. introduction ............................................................................... 472 a. the birth of the conscience clause and the path of expansion ................................................................................. 472 b. implications for stem cell based treatments .......................... 474 c. summary .................................................................................. 475 ii. conscience clause legislation .............................................. 476 a. development of federal conscience clause legislation ........ 476 1. the church amendments ................................................... 476 2. the danforth amendment ................................................. 477 3. omnibus consolidated rescissions and appropriations act ...................................................................................... 477 4. balanced budget act ......................................................... 477 5. hyde-weldon amendment ................................................. 478 b. congressional intent behind the limited scope of included services in conscience clause legislation .............................. 478 c. differences between state and federal conscience clauses and the variation among the states ......................................... 479 d. reconciling the differences in the scope of conscience clause protections among jurisdictions ................................ 481 e. policies regarding embryonic stem cell during the bush and obama administrations .................................................... 481 iii. stem cell based treatments ................................................... 482 a. an overview of stem cells ....................................................... 482 1. what is a cell? .................................................................. 482 2. what are stem cells? ........................................................ 483 3. embryonic stem cells v. adult stem cells ........................ 484 4. induced pluripotent stem cells ......................................... 485 5. moral objections to stem cell based treatments ............ 485 iv. differences between stem cell based treatments and procedures traditionally included in conscience clauses ......................................................................................... 488 a. stronger conflict with health care professionals’ duty of care ......................................................................................... 488 b. heightened importance of patient access to procedures ........ 489 c. diminished weight of health care professionals’ right to * j.d. candidate, 2011, indiana university school of law – indianapolis; b.a., 2007, augustana college, rock island, illinois. 472 indiana health law review [vol. 8:2 protection of conscience ......................................................... 490 d. objectionable ends or objectionable means? ........................ 490 e. different rights implicated ...................................................... 491 v. three possible avenues of expansion of conscience clause protections to include stem cell based treatments .................................................................................. 491 a. overly broad state conscience clauses .................................. 492 b. legislative expansion of current conscience clauses ........... 492 c. possible “back door” classification of stem cell based treatments as currently enumerated procedures ................... 492 vi. proposal ....................................................................................... 494 a. explicit and proactive reconsideration by legislators of how current conscience clauses would apply to stem cell based treatments ............................................................. 495 b. the benefits of explicit and proactive reconsideration.......... 495 1. a more accurate reflection of public opinion ................. 495 2. clarification of the law, removal of uncertainty ............ 495 3. proper balancing of right of refusal and patient access ................................................................................ 495 vii. conclusion .................................................................................. 496 i. introduction conscience clause legislation began with a fairly narrow focus: protecting physicians from being compelled to provide abortions. in subsequent decades, it expanded to include more classes of people and more types of procedures. this expansion now threatens to collide with the development of medical treatments derived from stem cells. under current conscience protection laws, it is possible that doctors in many jurisdictions will be allowed to decline to provide potentially life-saving treatments; a result which was never contemplated by early conscience clauses and not intended by any but the most expansive of current state conscience clauses. a. the birth of the conscience clause and the path of expansion in the wake of the landmark 1973 supreme court decision in roe v. wade,1 the prospect of being obligated to perform abortions, despite their serious moral and religious objections to the procedure, became an alarming reality for many health care professionals.2 shortly thereafter, congress 1. see roe v. wade, 410 u.s. 113 (1973) (holding that a woman may elect to terminate her pregnancy, for any reason, before the fetus becomes viable; and defining viability as the potential to “live outside the mother’s womb, albeit with artificial aid”). 2. see jody feder, cong. res. serv., rs21428, the history and effect of 2011] stem cell based treatments and conscience clause legislation 473 stepped in to allay these fears with the creation of the first federal conscience clause legislation, known as the church amendments.3 in the decades following congress’ first step, federal conscience protection has incrementally expanded, and most of the states followed suit by enacting their own conscience clause legislation.4 though the construction of conscience clauses, as well as the scope of entities and procedures that are covered, vary significantly among the states, each advances the same general objective of “allow[ing] medical providers to refuse to provide services to which they have religious or moral objections.”5 the protections created by the church amendments were fairly narrow, covering only a medical professional’s right to refuse to perform sterilization or abortion procedures.6 the subsequent path of conscience clause legislation has largely been one of expansion.7 the scope of this type of legislation has grown from sterilization and abortion to include procedures such as the termination of life support or the non-dispensation of contraception,8 with the most expansive state conscience clauses creating an unqualified right to decline to provide any medical service or procedure to which one is morally or religiously opposed.9 abortion conscience clause laws (2006), available at http://www.policyarchive.org/ handle/10207/bitstreams/3696.pdf (describing the passage of the church amendments as a reaction to roe v. wade). 3. 42 u.s.c. § 300a-7 (2010) (known as the church amendments; providing that an individual’s or organization’s receipt of federal funds authorized under certain enumerated acts does not obligate that individual or entity to perform, assist with, or provide personnel or facilities for, abortion or sterilization procedures when doing so would be contrary to religious beliefs or moral convictions). 4. guttmacher inst., state policies in brief: refusing to provide health services 1-2 (2011), available at http://www.guttmacher.org/statecenter/spibs/spib_ rphs.pdf. as of apr. 1, 2011, forty-six states, all except alabama, new hampshire, vermont and west virginia, have adopted some type of conscience clause legislation which, at a minimum, allows some individual health care professionals to refuse to provide abortion procedures; however, many of these state clauses are more expansive and include individuals or organizations which are tangential to the direct provision of procedures, or procedures other than abortion, such as sterilization or the provision of contraception. 5. see feder, supra note 2, at 1. 6. see 42 u.s.c. § 300a-7 (2010) (enumerating only abortion and sterilization as protected procedures). 7. see feder, supra note 2, at 1 (“[c]onscience clause laws have grown to encompass protections for entities that object to a wide array of medical services and procedures . . .”); see also maxine m. harrington, the ever-expanding health care conscience clause: the quest for immunity in the struggle between professional duties and moral beliefs, 34 fla. st. u. l. rev. 779, 784 (2007) (detailing the various efforts to expand conscience clause protections). 8. see ga. code ann. § 31-32-10(b) (west 2009) (providing protection from civil liability for any person who, in good faith, refuses to comply with an individual’s instructions regarding the withdrawal of life-sustaining procedures or nourishment); see also ariz. rev. stat. ann. § 36-2154 (2010) (providing that any “pharmacy, hospital or health professional” or any of their employees, may decline to provide emergency contraception on moral or religious grounds); see also feder, supra note 2, at 1. 9. see miss. code ann. § 41-41-215 (west 2009) (the mississippi state conscience clause). 474 indiana health law review [vol. 8:2 b. implications for stem cell based treatments conscience clauses laudably protect health care professionals’ interest in freedom from being compelled to perform procedures to which they have moral or religious objections. however, in some circumstances, the exercise of this right can impinge on patients’ reciprocal interests in obtaining these procedures.10 critics of the general concept of conscience protection legislation have long argued that these clauses restrict patient access to procedures; either as a result of the logistic difficulties in finding a willing health care professional (especially in the era of managed care), or by depriving a patient of complete disclosure of all medical options available to them because a health care professional may find some of those options personally objectionable.11 the long history of federal conscience legislation and the near ubiquity of state conscience clauses tend to imply that the majority of the public believes that the potential harm to patients outweighs the benefits of conscience protection for health care providers.12 however, the majority of conscience clauses apply only to abortion procedures and it is unclear whether the general public would favor a conscience clause that included procedures, which were either significantly more beneficial or less objectionable. 13 this scenario is on the horizon with the impending development of stem cell based treatments. although effective stem cell based treatments are not yet a reality, the field shows great promise. it is expected that soon such treatments will remedy a host of ailments for which there are currently few or no effective treatments, including: alzheimer’s, parkinson’s and lou gehrig’s disease, spinal paralysis, inflammatory bowel syndrome, macular degeneration, diabetes, and many cancers.14 despite the potential benefits, many health care 10. see generally georgia chudoba, conscience in america: the slippery slope of mixing morality with medicine, 36 s.u. l. rev. 85 (2007) (detailing several arguments against the general concept of conscience clauses in the health care field). 11. id. at 95-97. 12. guttmacher inst., supra note 4, at 1-2 (as of apr. 1, 2011, forty-six states have enacted some form of conscience clause legislation). 13. id. (as of apr. 1, 2011, forty-six states provide conscience protection for abortion procedures, but only eighteen include sterilization procedures and only fourteen include the provision of contraception). 14. see, e.g., daniel j. denoon, the future of stem cells: disease research hindered by reproductive cloning threat, experts say, webmd.com (july 8, 2004), http://www.webmd.com/alzheimers/news/20040708/future-of-stem-cells (stating that stem cells could potentially be used to treat alzheimer’s and parkinson's diseases, cancer, spinal paralysis, and other ailments); see also, e.g., andrew pollack, pfizer acquires a stem-cell therapy, n.y. times.com (dec. 21, 2009), http://www.nytimes.com/2009/12/21/business/2 1pfizer.html (stating that pfizer has acquired the rights to a potential stem cell based therapy for inflammatory bowel disease, and is also researching stem cell based treatments for macular degeneration and diabetes); see also, e.g., inst. for quality and efficiency in health care, women with breast cancer may benefit from autologous stem cell transplantation, 2011] stem cell based treatments and conscience clause legislation 475 professionals have religious or moral objections to their use because certain types of stem cells can only be derived from fertilized embryos, which are destroyed in the process of harvesting stem cells.15 the use of these cells implicates the same moral and ethical issues at the heart of the abortion and contraception debate, namely the belief that human life begins at fertilization.16 the continued expansion of conscience clauses threatens to swallow procedures based on stem cell use. while the moral objections to utilizing embryonic stem cells are often rooted in the same principles as objections to abortion, the differences between these types of procedures are so great as to warrant an entirely different analysis when considering their inclusion in conscience clauses. c. summary part ii of this note examines both the historical development of conscience clauses at the federal level and the variation among conscience clauses adopted by the majority of the states. in addition to laying out the current landscape of conscience clause legislation, part ii also explores the interests and intent these clauses embody and the reasons for their variation. part iii defines the term “stem cell” and identify the unique potential that treatments derived from stem cells possess, and notes the reasons why some find stem cell based treatments morally objectionable. part iv of this note analyzes the major differences between the emerging stem cell based treatments and those procedures which were the traditional targets of conscience clause legislation. part iv also attempts to explain why these differences warrant a different analysis for stem cell based treatments in the context of deciding whether or not these treatments should be covered by conscience clauses. part v explores three possible avenues that could bring stem cell based treatments under the umbrella of current conscience clauses and the negative implications that would result from each. finally, part vi offers a proposal calculated to ensure that the relationship between stem cell based treatments and conscience clauses is determined explicitly by all affected sciencedaily.com (jan. 13, 2010), http://www.sciencedaily.com/releases/2010/01/ 100112122427.htm; see also, e.g., letizia mazzini, et al., stem cells in amyotrophic lateral sclerosis: state of the art, 9.10 expert op. on biological therapy 1245, 1245-58 (2009), available at http://www.ncbi.nlm.nih.gov/pubmed/19663719. 15. nat’l inst. of health, stem cell basics 1, 2 (2009), available at http://stemcells.nih.gov/staticresources/info/basics/scprimer2009.pdf. 16. see the pew forum on religion and public life, religious groups’ official positions on stem cell research, the pew forum.org (july 17, 2008), http://pewforum.org/ science-and-bioethics/religious-groups-official-positions-on-stem-cell-research.aspx (outlining the official position of several prominent religious groups’ opposition to the destruction of fertilized embryos and belief that human life begins at conception); see also steven ertelt, abortion poll finds most christians think life begins at conception, lifenews.com, (jan. 16, 2007), http://www.lifenews.com/nat2870.html (describing a poll in which 440 out of the 500 christians surveyed responded that life begins at the moment of conception). 476 indiana health law review [vol. 8:2 parties and in a manner that appropriately balances the right of refusal for health care professionals and the potential life saving benefits that these procedures promise to provide. ii. conscience clause legislation examining the historical course of development of federal and state conscience clauses, as well as their similarities and differences, not only explains how the current framework of legislation arose, but also reveals the range of motivations, intentions, and values placed on the interests of health care professionals and patients by the general public. a. development of federal conscience clause legislation while the story of both federal and state conscience clause legislation is largely one of expansion, congress has historically shown far more restraint than state legislatures. the expansion of federal conscience protection has primarily taken the form of including more classes of people, while simultaneously limiting the services included to those related to abortion or contraception. 1. the church amendments in 1973, the first federal conscience clause legislation, known as the church amendments,17 was passed as a reaction to the supreme court’s decision permitting abortion in roe v. wade.18 the first pertinent section protects any individual or organization that receives certain federal aid from being compelled to participate in, assist in the performance of, or provide personnel for sterilization or abortion procedures which conflict with that individual’s or organization’s religious beliefs or moral convictions.19 the second pertinent section goes further, protecting individuals from discrimination in employment, promotion, termination or extension of staff privileges on the basis of that individual’s position on, or past decisions regarding the performance of sterilizations or abortions.20 the church amendments broadly protected an array of privileges for health care providers, but explicitly limited those protections to the context of abortion or sterilization.21 17. 42 u.s.c. § 300a-7 (2010). 18. roe v. wade, 410 u.s. 113 (1973). 19. 42 u.s.c. § 300a-7(b) (2010). 20. id. § 300a-7(c) (2010). 21. see id. § 300a-7 (2010) (enumerating only abortion and sterilization as protected procedures). 2011] stem cell based treatments and conscience clause legislation 477 2. the danforth amendment next came the danforth amendment of 1978, 22 which provided that nothing in title ix of the education amendments of 1972, 23 “shall be construed to require or prohibit any person, or public or private entity, to provide or pay for any benefit or service . . . related to an abortion” nor “to permit a penalty to be imposed on any person or individual because such person or individual is seeking or has received any benefit or service related to a legal abortion.”24 this amendment extended protections to taxpayers and women who received abortions. while the amendment protected a much larger group of people, the procedures it targeted were even more restrictive than the church amendments, as it concerned only abortion. 3. omnibus consolidated rescissions and appropriations act the omnibus consolidated rescissions and appropriations act of 1996 prohibited the federal government, or any state government receiving federal aid, from discriminating against a health care entity on the basis of that entity’s provision or non-provision of training related to abortion procedures.25 again, congress expanded the class of recipients for conscience protection, but restricted the context to services related to abortion procedures. 4. balanced budget act the next and arguably most significant expansion of federal conscience protection was contained within the balanced budget act of 1997.26 this act made several amendments to the medicare and medicaid programs.27 addressing the concern that managed care plans might restrict health care professionals from informing their patients about services not covered under those plans,28 congress prohibited the imposition of any such limitations on health care professionals’ discussion of medical options.29 22. 20 u.s.c. § 1688 (2010) (the danforth amendment). 23. id. § 1681 (2010) (title ix of the education amendments of 1972, prohibiting discrimination on the basis of sex under any educational program or activity receiving federal funding, this legislation was the backbone for the danforth amendment). 24. 20 u.s.c. § 1688 (2010). 25. 42 u.s.c. § 238n(a) (2010). 26. balanced budget act of 1997, pub. l. no. 105-33, 111 stat 251 (2010) (omnibus legislative package), available at http://www.gpo.gov:80/fdsys/pkg/plaw-105publ33/pdf/ plaw-105publ33.pdf. 27. see id. 28. see feder, supra note 2, at 3. 29. § 1852, 111 stat. at 286-99 (omnibus legislative package); 42 u.s.c. § 1395w22(j)(3)(b) (2010) (the codification of the pertinent medicare conscience clause provision); 42 u.s.c. § 1396u-2(b)(3)(b) (2010) (the codification of the identical medicaid conscience 478 indiana health law review [vol. 8:2 however, the act also exempted those managed care providers from the requirement to pay for any service the managed care plan found religiously or morally objectionable.30 this amendment represented an expansion of federal conscience clause protection in two major ways: through an expansion of conscience protection to companies who merely finance services, and also through a potential expansion of protected services beyond abortion or sterilization procedures.31 5. hyde-weldon amendment in 2004, the hyde-weldon amendment was inserted into the appropriations bill for the department of health and human services.32 it provided in part that “no federal agency or program, nor any state or local government, may receive health and human services funding if it discriminates against a healthcare entity because it ‘does not provide, pay for, provide coverage of, or refer for abortions.’”33 like the omnibus consolidated rescissions and appropriations and balanced budget acts, the hydeweldon amendment expanded the list of protected services beyond the physical provision of abortion procedures, but not beyond services, which bear some ultimate connection to the provision of abortions. b. congressional intent behind the limited scope of included services in conscience clause legislation a common theme of federal conscience legislation has been the extension of protections to more people and to more situations, while at the same time reflecting a hesitancy to extend protections to all types of moral objections, opting to limit the scope to abortion procedures and related services. congress’ intent not to expand conscience protection to other procedures is not only discernable from the statutory text, it is also directly supported by the legislative history. representative dave weldon, the pro-life, proconscience clause congressman from florida, , in a statement before the house of representatives in 2002, made it clear that federal conscience clause provision); see also feder, supra note 2, at 3. 30. § 1852, 111 stat at 286-99 (omnibus legislative package); 42 u.s.c. § 1395w22(j)(3)(b) (2010) (the codification of the pertinent medicare conscience clause provision); 42 u.s.c. § 1396u-2(b)(3)(b) (2010) (the codification of the identical medicaid conscience clause provision); see also feder, supra note 2, at 3. 31. feder, supra note 2, at 3. 32. consolidated appropriations act of 2005, pub. l. no. 108-447, § 508(d)(1), 118 stat. 2809, 3163 (2004), available at http://www.gpo.gov:80/fdsys/pkg/plaw108publ447/pdf/plaw-108publ447.pdf; catherine grealis, religion in the pharmacy: a balanced approach to pharmacists' right to refuse to provide plan b, 97 geo. l.j. 1715, 1719 (2009). 33. grealis, supra note 32, at 1719. 2011] stem cell based treatments and conscience clause legislation 479 clause legislation was not intended to include procedures other than abortion: contraception is not defined by the fda as abortion. the morning-after pill is not defined by the fda as abortion. it is defined as contraception. it is something different. so to interpret this statute to claim that it is going to prohibit access is to take essentially a religious entity's doctrine and put that into the statute, and it is just not there. it is not in the language.34 while most state conscience clauses conform to the federal model,35 some have extended protections to enumerated procedures other than abortion and sterilization,36 and a few have created an absolute right to decline to provide any procedure for which one has a moral objection.37 c. differences between state and federal conscience clauses and the variation among the states the construction of the majority of conscience clause legislation reveals an intention to balance conscience protection for health care professionals against patient access to legal procedures by enumerating the types of services health care professionals can decline to provide on moral grounds. federal conscience clause legislation has kept a fairly consistent focus, centered on the enumerated services of abortion and sterilization. most federal conscience protection legislators have been wary of extending an absolute right to decline to perform any service that might be against a health care provider’s religious beliefs or moral convictions. the church amendments,38 the danforth amendment,39 the omnibus consolidated rescissions and appropriations act,40 and the hyde-weldon amendment,41 all 34. 148 cong. rec. h6566-01 (daily ed. sept. 25, 2002) (statement of rep. weldon in response to the claim that previous federal conscience clauses extended to procedures other than abortion or sterilization, namely contraception). 35. see ind. code ann. § 16-34-1-4 (west 2009). 36. ariz. rev. stat. ann. § 36-2154 (2010) (providing that any “pharmacy, hospital or health professional” or any their employees, may decline to provide emergency contraception on moral or religious grounds). 37. see miss. code ann. § 41-41-215(5) (west 2009). 38. 42 u.s.c. § 300a-7 (2010) (the church amendments, providing specifically “performance of any sterilization procedure or abortion”). 39. 20 u.s.c.a. § 1688 (the danforth amendment, providing specifically “has received any benefit or service related to a legal abortion”). 40. 42 u.s.c. § 238n(a) (west 2010) (the ocraa, referencing only abortions). 41. consolidated appropriations act, 2005, pub. l. no. 108-447, § 508(d)(1), 118 stat. 2809, 3163 (2004), available at http://www.gpo.gov:80/fdsys/pkg/plaw108publ447/pdf/plaw-108publ447.pdf (providing specifically “provide, pay for, provide coverage of, or refer for abortions”). 480 indiana health law review [vol. 8:2 restrict conscience protection to either abortion and sterilization procedures, or abortion procedures alone. similarly, state conscience clause legislation has traditionally focused on the enumerated services of abortion, sterilization and contraception. currently, forty-six states have enacted conscience clauses that allow some health care professionals to refuse to perform abortions.42 fourteen states allow some health care professionals to refuse to provide contraception.43 eighteen states allow some health care professionals to refuse to provide sterilizations.44 though the scope of the majority of state statutes is limited to the enumerated procedures of abortion, sterilization, or contraception, a few have a much broader scope. mississippi’s conscience clause is arguably one of the broadest.45 unlike the majority of conscience clauses, it does not enumerate which services a health care professional may decline to provide: a health-care provider may decline to comply with an individual instruction or health-care decision for reasons of conscience. a health-care institution may decline to comply with an individual instruction or health-care decision if the instruction or decision is contrary to a policy of the institution which is expressly based on reasons of conscience and if the policy was timely communicated to the patient or to a person then authorized to make health-care decisions for the patient.46 this broadly drawn provision allows a health care professional total discretion in refusing to provide any service that he or she finds morally objectionable. it has been criticized as being excessively skewed in favor of health care professionals and unreasonably broad.47 42. guttmacher inst., supra note 4, at 1, see, e.g., ind. code ann. § 16-34-1-4 (west 2009). alabama, new hampshire, vermont and west virginia are the only four states that do not allow health care professionals to refuse to provide abortion services. 43. guttmacher inst., supra note 4, at 1, see e.g., ariz. rev. stat. ann. § 36-2154 (2010). the fourteen states that allow some heath care professionals to refuse to provide contraception are arkansas, california, colorado, florida, georgia, idaho, illinois, maine, massachusetts, mississippi, new jersey, south dakota, tennessee, and washington. 44. guttmacher inst., supra note 4, at 1, see, e.g., ark. code ann. § 20-16-304 (west 2010). the eighteen states that allow some heath care professionals to refuse to provide sterilization procedures are arkansas, georgia, idaho, illinois, kansas, kentucky, maine, maryland, massachusetts, mississippi, montana, new jersey, new mexico, pennsylvania, rhode island, washington, west virginia, and wisconsin. 45. see miss. code ann. § 41-41-215 (west 2009); see also harrington, supra note 7, at 785-86. 46. miss. code ann. § 41-41-215(5) (west 2009) (emphasis added). 47. see generally, harrington, supra note 7. 2011] stem cell based treatments and conscience clause legislation 481 indiana’s conscience clause is typical of those on the more traditional end of the spectrum. it provides: no physician; or employee or member of the staff of a hospital or other facility in which an abortion may be performed; shall be required to perform an abortion or to assist or participate in the medical procedures resulting in or intended to result in an abortion, if that individual objects to such procedures on ethical, moral, or religious grounds.48 like the majority of state conscience clauses, it explicitly limits the protection of conscience to “procedures resulting in . . . an abortion.”49 d. reconciling the differences in the scope of conscience clause protections among jurisdictions the divergent approaches to and the wide-ranging scope of conscience clause legislation make it clear that there is no single, universally accepted conscience clause. the best solution will continue to be determined by balancing the values that the individuals in a jurisdiction place on health care professionals’ interests in protecting their consciences, patient’s interests in the ease of access to procedures, and the utility and ethical soundness of the gambit of medical services. even though most individuals have clearly defined and generally polarized opinions about the value of services like abortion, sterilization, and contraception, striking the right balance is still extremely difficult. this task would be exponentially more difficult if there was a service that did not fall neatly to either side, a service that might pose similar moral problems but at the same time offered a universally desirable benefit. the emergence of stem cell based treatments and their novel and profound differences from traditional targets of conscience clauses threaten to potentially turn the traditional, majoritarian balance on its head. e. policies regarding embryonic stem cell during the bush and obama administrations in 2001, president bush issued a directive which prohibited the use of federal dollars to fund research involving certain stem cell lines.50 funds would only be issued for research on embryonic stem cell lines which were 48. ind. code ann. § 16-34-1-4 (west 2009) (the indiana state conscience clause). 49. id. 50. nat’l inst. of health, nih's role in federal policy, nih stem cell information, http://stemcells.nih.gov/policy/nihfedpolicy.asp (last modified on oct. 6, 2006). 482 indiana health law review [vol. 8:2 derived from embryos before august 9, 2001 and only from those embryos which were originally created for reproductive purposes and no longer needed.51 this effectively restricted research to the seventy one currently existing embryonic stem cell lines in existence throughout the world at that time.52 president obama issued an executive order in march of 2009 which reversed this ban on federal funding.53 the current administration has sided with the “majority of americans” in recognition of the great potential stem cell based treatments may hold.54 iii. stem cell based treatments the scientific community has known about stem cells since their discovery over fifty years ago.55 they initially raised little controversy and were mostly unknown by the general public until 1998, when scientists discovered a way to derive and grow human stem cells from fertilized embryos.56 this discovery was a major breakthrough, and while it was the first step toward previously unimaginable therapies and cures, it was also a step into uncharted ethical territory. over ten years later, we are still wrangling with many of the same ethical and legal questions. tackling these questions requires knowing what stem cells are, why they offer such grand therapeutic promise, and where moral objections to stem cell research and potential stem cell based treatments originate. a. an overview of stem cells 1. what is a cell? cells are the basic building blocks of all living things.57 every human being is composed of trillions of microscopic cells.58 while all human cells have the same basic parts, their structures and functions are extremely di 51. id. 52. id. 53. cbs & the associated press, obama ends stem cell research ban, http://www.cbsnews.com/stories/2009/03/09/politics/100days/domesticissues/main4853385. shtml (last modified on mar. 9, 2009). 54. id. 55. nat’l inst. of health, stem cell basics: what are adult stem cells?, nih stem cell information, http://stemcells.nih.gov/info/basics/basics4 [hereinafter stem cell basics: what are adult stem cells?] (last modified on aug. 5, 2010). 56. nat’l inst. of health, stem cell basics: introduction, nih stem cell information, http://stemcells.nih.gov/info/basics/basics1 [hereinafter stem cell basics: intro] (last updated aug. 5, 2010). 57. a science primer: a basic introduction to the science underlying ncbi resources, what is a cell?, nat’l ctr. for biotechnology info., http://www.ncbi.nlm. nih.gov/about/primer/genetics_cell.html (last updated mar. 30, 2004). 58. id. 2011] stem cell based treatments and conscience clause legislation 483 verse.59 every adult cell contains a full copy of the individual’s unique set of deoxyribonucleic acid (“dna”).60 the dna within every adult cell contains the instructions for building any type of cell and controls the structure and function of the cell it occupies.61 human cells are created by one of two processes, meiosis or mitosis.62 in both meiosis and mitosis, an adult cell divides itself into two smaller cells; the difference between these processes is the amount of dna each new cell carries.63 mitosis results in two new cells, each with a full copy of dna.64 this is how old cells replace themselves when they get worn out and how plants and animals are able to grow.65 however, in order for mitosis to occur in a new individual, there must be a first cell; and this first cell is created, in part, by meiosis.66 meiosis results in two new cells, either two sperm cells or two eggs, each possessing half of a copy of dna.67 fertilization occurs when a sperm cell and an egg cell combine to form a new individual; each cell contributes its half dna to create a new cell.68 this new single cell is called a zygote and through mitosis it divides and grows into a new individual.69 each cell in the body has a specific purpose, such as transporting oxygen or detecting light.70 once a cell adopts a particular structure or purpose it is said to be differentiated and it will remain as that type of cell indefinitely.71 when it divides using mitosis, the two new cells can only become the type of cell from which they originated.72 2. what are stem cells? a stem cell is a cell that has not yet differentiated into a specific cell type.73 unlike differentiated cells, stem cells have the potential to develop into any cell type.74 it is this characteristic that gives stem cells their therapeutic promise.75 these cells can replicate themselves for long periods of time, and a small culture of stem cells can proliferate into millions after 59. id. 60. id. 61. id. 62. id. 63. id. 64. id. 65. id. 66. id. 67. id. 68. id. 69. id. 70. id. 71. id. 72. id. 73. nat’l inst. of health, supra note 15, at 1. 74. id. at 4. 75. id. at 2. 484 indiana health law review [vol. 8:2 several months.76 because stem cells have the ability to differentiate into any type of cell, they have tremendous potential in the treatment of many diseases and injuries for which there are no traditional remedies.77 certain types of cells, like those found in the spinal cord, do not replicate frequently and therefore cannot heal after more serious damage.78 if undifferentiated stem cells could be coaxed into differentiating into spinal nerve cells, it may be possible to ameliorate some of the damage caused by spinal cord injuries.79 this is just one example of the novel therapeutic uses for stem cells. 3. embryonic stem cells v. adult stem cells embryonic stem cells are derived from very early stage embryos before cell differentiation starts to occur.80 stem cells are extracted from these early stage embryos, called blastocysts, about four days after the embryo is created.81 an adult stem cell is a stem cell that is found, undifferentiated, among the body tissue of an already developed organism.82 each has advantages and disadvantages regarding potential use in stem cell based treatments.83 the first difference is with the types of cells into which each has the ability to differentiate.84 embryonic stem cells can become any of the cell types within the body, a characteristic known as pluripotentcy.85 adult stem cells, however, are believed to be limited to differentiating into only those cell types from those tissues or organs from which they originated.86 76. nat’l inst. of health, stem cell basics 2 (2009), available at http://stemcells.nih.gov/info/basics/basics2.asp (last modified apr. 28, 2009). 77. nat’l inst. of health, stem cell basics 7 (2009), available at http://stemcells.nih.gov/info/basics/basics6.asp (last modified apr. 28, 2009). 78. daniel stimson, combination therapy stimulates spinal cord regeneration in rats more than one year after injury, nat’l inst. of neurological disorders and stroke (feb. 1, 2010) http://www.ninds.nih.gov/news_and_events/news_articles/combo_ therapy_sci.htm (“several factors make it difficult to recover from injury to the spinal cord. although the developing spinal cord contains signals that encourage nerve cells to grow, by adulthood those have been replaced by signals that inhibit growth and maintain stable connections. changes within nerve cells themselves also direct them to stop growing as they mature.”). 79. see denoon, supra note 14 (stating stem cell based treatments could reverse spinal paralysis). 80. james a. thomson, et al., embryonic stem cell lines derived from human blastocysts, 282 sci. 1145, 1145-47 (1998); nat’l inst. of health, stem cell basics 3 (2009), http://stemcells.nih.gov/info/basics/basics3.asp (last modified sep. 13, 2010). 81. a science primer: a basic introduction to the science underlying ncbi resources, what is a cell?, nat’l ctr. for biotechnology info., http://www.ncbi.nlm.nih.gov/about/primer/genetics_cell.html (last updated mar. 30, 2004). 82. nat’l inst. of health, stem cell basics, supra note 15, at 4. 83. id. at 12. 84. id. 85. id. at 5, 12. 86. id at 12. 2011] stem cell based treatments and conscience clause legislation 485 embryonic stem cells have other advantages as well. they are easier to maintain in laboratory setting and can be extracted more easily than adult stem cells.87 this is a critical difference because large numbers of cells would likely be required for stem cell based treatments.88 however, adult stem cells are currently thought to be less likely than embryonic stem cells to be rejected after a transplant.89 this is an important advantage for adult stem cells because immune rejection can only be circumvented by continuous administration of immunosuppressive drugs, which often come with serious side effects.90 4. induced pluripotent stem cells induced pluripotent stem cells (ipscs) are adult cells that have been genetically reprogrammed to an embryonic stem cell–like state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. although these cells meet the defining criteria for pluripotent stem cells, it is not known if ipscs and embryonic stem cells differ in clinically significant ways.91 while not definitively superior, the use of embryonic stem cells poses less of a technological challenge adult stem cells.92 though ipscs might be able to replicate the functionality of embryonic stem cells, it is uncertain if their use will be feasible.93 5. moral objections to stem cell based treatments the grounds for most moral objections to stem cell based treatments centers almost exclusively around the use of embryonic stem cells because the collection of these cells necessarily requires obtaining or creating, and subsequently destroying, fertilized embryos.94 thus, the view one holds about the status of an embryo is an essential, and for many the only, factor in determining one’s moral or ethical stance on the use of stem cell based 87. see id. at 13. 88. id. 89. id. 90. id. 91. id. 92. nat’l inst. of health, stem cell basics 5 (2009), available at http://stemcells.nih.gov/info/basics/basics5.asp (last modified jan. 20, 2011). 93. nat’l inst. of health, stem cell basics 6 (2009), available at http://stemcells.nih.gov/info/basics/basics6.asp (last modified apr. 28, 2009). 94. see 1 nat’l bioethics advisory comm’n, ethical issues in human stem cell research 49, 49-51 (1999), available at http://bioethics.georgetown.edu/nbac/stemcell.pdf. 486 indiana health law review [vol. 8:2 treatments. views on the status of embryos fall along a spectrum, but can generally be classified into three categories.95 at one end of the spectrum, embryos are viewed simply as small clusters of cells not unlike any other cluster of cells found in the human body.96 those who hold this view believe that embryos present no greater ethical or moral significance than a sample of blood, and deserve little or no special treatment.97 at the opposite end of the spectrum, embryos are viewed as having nearly the same status as fully formed human beings, because an embryo possesses the potential to form a human being.98 the third view falls somewhere in between these extremes, recognizing that an embryo has properties which give it greater status than a simple cell cluster, but not so great as to put it on par with a fully-developed person.99 the largest and most vocal opposition to the use of embryonic stem cells originates from various religious groups. a number of religious groups have offered official positions on stem cell research, including: catholicism,100 episcopalism,101 hinduism,102 islam,103 judaism,104 the luther 95. id. at 49-50. 96. id. at 49. 97. id. 98. id. 99. id. at 50. 100. the pew forum on religion and public life, supra note 16 (“in accordance with their anti-abortion stance, the u.s. conference of catholic bishops supports adult stem cell research but opposes embryonic stem cell research since it creates or destroys human embryos.”) (citing, catholic support for ethically acceptable stem cell research, u.s. conference of catholic bishops, http://www.usccb.org/prolife/issues/bioethic/stemcell/ stemcath.shtml (last visited mar. 17, 2011)). 101. id. (“in 2004, the church’s governing body, the general convention, declared itself in favor of stem cell research as long as the embryos used would have been destroyed otherwise, the embryos were not created solely for research purposes and the embryos were not bought or sold.”) (citing acts of convention: resolution # 2003-a014, the archives of the episcopal church, http://www.episcopalarchives.org/cgi-bin/acts/acts_resolution.pl? resolution=2003-a014 (last visited mar. 17, 2011)). 102. id. (“though hinduism believes that life begins at conception, the religion has no official position on stem cell research.”) (citing pankaj mishra, how india reconciles hindu values and biotech, n.y. times.com (aug. 21, 2005), http://www.nytimes.com/2005/08/21/ weekinreview/21mishra.html?_r=1&pagewanted=all). 103. id. (“there is no explicit islamic ruling on the issue of stem cell research. while some muslim leaders allow for stem cell research on the ground that, according to islam, an embryo in the early stage of pregnancy does not have a soul, others argue that the termination of an embryo at any stage of pregnancy is morally impermissible.”) (citing dr. muzammil siddiqi, an islamic perspective on stem cells research, islam 101.com, http://www.islam101.com/science/stemcells.htm (last visited mar. 7, 2011)). 104. id. (“all major jewish denominations – including the reform, conservative, orthodox and reconstructionist movements – support both embryonic and adult stem cell research as long as it is for medical or therapeutic purposes.”) (citing religious action ctr. of reform judaism, stem cell research, rac.org, http://rac.org/advocacy/issues/stemcell/# rjm (last updated july 26, 2005)). 2011] stem cell based treatments and conscience clause legislation 487 an church-missouri synod,105 the national association of evangelicals,106 the presbyterian church (u.s.a.),107 the southern baptist convention,108 the unitarian universalist association of congregations,109 the united church of christ,110 and the united methodist church.111 the view that an embryo should have the same legal and moral status as a fully developed human is the fundamental argument advanced by those who are opposed to any destruction of embryos.112 the objection to the use of embryonic stem cells comes from the same moral principle as the objection to abortion, but the differences between stem cell based treatments and procedures, like abortion and sterilization, warrant a comparatively elevated level of consideration. 105. id. (“in 2005, the group reaffirmed its opposition to embryonic stem cell research, advocating instead for adult stem cell research.”) (citing comm’n on theology & church rel. of the lutheran church—missouri synod, christian faith and human beginnings: christian care and preimplementation human life 1 (2005), available at http://www.lcms.org/graphics/assets/media/ctcr/ctcr%20human%20beginnings.pdf). 106. the pew forum on religion and public life, supra note 16 (“in 2005, the national association of evangelicals issued a statement voicing its opposition to stem cell research.”) (citing nat’l ass’n of evangelicals, bioethics and stem cell research, nae.net (mar. 11, 2005), http://www.nae.net/government-affairs/policy-resolutions/90-bioethics-a-stem-cellresearch-2005). 107. id. (“in 2004, the presbyterian church’s governing body, the general assembly, reaffirmed its position in favor of stem cell research that is intended to ‘[restore health] to those suffering from serious illness.’”) (citing the wash. off., next steps: federal funding for stem cell research, the wash. off. (2004), http://archive.pcusa.org/washington/issue net/hc-050802.htm). 108. id. (“in 1999, the southern baptist convention reaffirmed its ‘opposition to the destruction of human embryos . . . [and] support for the development of alternative treatments which do not require human embryos to be killed.’”) (citing southern baptist convention, resolution on human embryonic and stem cell research, sbc.net (june 1999), http://www.sbc.net/resolutions/amresolution.asp?id=620). 109. id. ( “in 2006, the association’s policymaking body, the general assembly, stated its support for stem cell research as long as the research is for medical therapies and not the reproductive cloning of humans.”) (citing unitarian universalist association of congregations, pass the stem cell research enhancement act, uua.org, http://www.uua.org/social justice/socialjustice/statements/8064.shtml (last updated june 3, 2010)). 110. id. (“in 2001, the united church of christ ruled in favor of research on embryonic stem cells that would otherwise be discarded from in vitro fertilization.”) (citing united church of christ, support for federally funded research on embryonic stem cells (2001), available at http://www.ucc.org/synod/resolutions/support-forfederally-funded-research-on-embryonic-stem-cells.pdf). 111. id. (“in 2004, the united methodist church asserted its support for therapeutic cloning in which spare embryonic stem cells resulting from in vitro fertilization are used. the church also maintained its opposition to the use or creation of embryonic stem cells solely for the purpose of research.”) (citing united methodist church, ethics of embryonic stem cell research, umc.org, http://archives.umc.org/interior.asp?ptid=4&mid=6560 (last visited mar. 17, 2011)). 112. 1 nat’l bioethics advisory comm’n, supra note 94. 488 indiana health law review [vol. 8:2 iv. differences between stem cell based treatments and procedures traditionally included in conscience clauses regardless of one’s moral stance on the procedures traditionally included by conscience clauses or one’s moral stance on the potential use of stem cell based treatments, the following differences warrant careful consideration when considering inclusion of stem cell based treatments under conscience clause protection. a. stronger conflict with health care professionals’ duty of care apart from rare exigent circumstances, it is usually not necessary for the health of the patient to require an abortion or contraception.113 since a delay or even a complete prevention of the receipt of these traditionally included services rarely poses a health risk, such a refusal would rarely conflict with a duty to provide care. unlike traditionally included services, a delay or prevention in receipt of a stem cell treatment could possibly cause serious injury or death. there is evidence contained in some conscience clauses that demonstrates that conscience clause protection was not meant to be extended to this extreme. for example, these certain conscience clauses contain additional provisions qualifying the freedom of a health care professional to decline to provide a particular service in non-emergency situations only.114 stem cell based treatments could provide the only viable treatment option for a wide array of diseases and injuries.115 the risk of harm to a patient’s health resulting from a refusal to perform a non-emergency abortion is trivial compared to the risk of harm to a patient’s health resulting from a refusal to provide an effective stem cell based treatment for serious and time-sensitive ailments, such as cancer. a delay in receiving a nonemergency abortion is unlikely to create or prolong physical pain and poses no direct risk to patient health, but even a short delay in getting treatment 113. julie cantor & ken baum, the limits of conscientious objection-may pharmacists refuse to fill prescriptions for emergency contraception?, 351 new eng. j. med. 2008, 2009 (2004) (except in emergency situations, physicians are generally free to choose patients and procedures). 114. e.g., 745 ill. comp. stat. ann. 70/6 (west 2010) (the illinois conscience clause, providing in part that “[n]othing in this act shall be construed so as to relieve a physician or other health care personnel from obligations under the law of providing emergency medical care.”). 115. denoon, supra note 14 (stating that stem cells could potentially be used to treat alzheimer’s and parkinson's diseases, cancer, spinal paralysis, and other ailments); pollack, supra note 14 (stating that pfizer has acquired the rights to a potential stem cell based therapy for inflammatory bowel disease, and is also researching stem cell based treatments for macular degeneration and diabetes); inst. for quality and efficiency in health care, supra note 14; mazzini et al., supra note 14, at 1245-58. 2011] stem cell based treatments and conscience clause legislation 489 for cancer could prolong serious pain.116 the same issues of time sensitivity and limited access are two of the main arguments against extending conscience clause protections to pharmacists for the dispensation of emergency contraception, and those arguments could apply with equal force to potential stem cell based treatments.117 the conflict between conscience protection of a health care professional’s right to decline to provide services thought to be objectionable and the duty to provide for the care and health of a patient would be significantly stronger when declining certain stem cell based treatments than when declining a service traditionally included in conscience clauses. b. heightened importance of patient access to procedures just because a particular health care provider is unwilling to provide a treatment does not mean that such a treatment is rendered unavailable to a patient. a health care professional can, and indeed may be obligated to, make arrangements for a patient requesting care to receive it from some other source.118 but such an arrangement is not a perfect solution and some patients who would have otherwise received the treatment, will not. a small number of patients may be unwilling or unable to see a second health care professional as the referral process will likely involve another appointment with additional costs and may even require travel to a new and possibly distant location. the benefits of protecting a health care professional’s right to refuse objectionable procedures probably justifies a risk of inconvenience to patients seeking abortions, but this balance is not as easily struck when the patient is seeking a remedy for severe pain or lack of mobility. this problem is compounded by the fact that many health care professionals “do not believe they are obligated to disclose information about medically available treatments they consider objectionable.”119 116. see timothy moynihan, cancer pain: relief is possible, mayo clinic.com (oct. 3, 2009), http://www.mayoclinic.com/health/cancer-pain/ca00021 (“cancer can cause pain by growing into or destroying tissue near the cancer. cancer pain can come from the primary cancer itself . . . as a tumor grows, it may put pressure on nerves, bones or other organs, causing pain.”); see also daniel levin et all, public attitudes toward cancer pain, 56 cancer 2337 (1985) (stating “presence of pain tends to shorten delay in seeking diagnosis for some patients”). 117. grealis, supra note 32, at 1720. 118. johnson v. vaughn, 370 s.w.2d 591, 596 (ky. 1963) (stating that a physician should not leave a patient who is in need of treatment without providing reasonable notice or arranging the patient’s transfer to another physician). 119. farr a. curlin et al., religion, conscience, and controversial clinical practices, 356 new eng. j. med. 593, 597 (2007) (where fourteen percent of surveyed physicians reported that they did “not believe they [were] obligated to disclose information about medically available treatments they consider[ed] objectionable”). 490 indiana health law review [vol. 8:2 c. diminished weight of health care professionals’ right to protection of conscience the principle behind all conscience clauses is that no one should be forced to do anything they find morally objectionable.120 this attitude of personal liberty pervades much of american culture and is deservingly a point of national pride. but the right to freedom of choice and protection of conscience has never been absolute, or without consequences. there are elements of every profession that are unavoidable, and a person with a moral or personal objection to those elements may be unable to adequately perform the job. a high-rise construction worker’s fear of heights cannot be accommodated. luckily, people are allowed to choose professions that suit their personal and moral temperaments. should stem cell based therapies become pervasive and efficient, we may encounter a medical landscape in which stem cell based treatments are the least expensive or most effective treatment for a large number of ailments. in this situation, health care professionals who abstain from using such treatments may be less and less able to offer effective or affordable care. in addition, most conscience clause legislation absolves health care providers of responsibility for declining to provide a service.121 much of the opposition to conscience clauses, namely restriction of access or potential for misinformation, could be eliminated if health care providers were explicitly required to assist patients in acquiring procedures they are not comfortable performing themselves. in this way, health care providers retain the same rights of refusal but would greatly decrease the risk of negative outcomes associated with their exercise of that right. d. objectionable ends or objectionable means? there is an important distinction between the moral objections to stem cell based treatments and the moral objections to services traditionally covered by conscience clauses. unlike abortion or contraception, the objection to stem cell based treatments lies in the means by which these treatments are created, not the ultimate results they produce. there is much debate over the social good of abortion and contraception, but few would dispute that the therapeutic possibilities that stem cell based treatments could offer are anything but positive. this is exemplified by the general acceptance of induced pluripotent stem cells as an alternative to embryonic stem cells.122 120. see feder, supra note 2, at 2. 121. see, e.g., ind. code ann. § 16-34-1-4 (west 2009); see also, e.g., miss. code ann. § 41-41-215 (west 2009). 122. see the pew forum on religion and public life, supra note 16 (survey of official positions on stem cell research of various religions showing that most endorse or are neutral on the issue of adult stem cells and oppose the use of embryonic stem cells). 2011] stem cell based treatments and conscience clause legislation 491 e. different rights implicated the basis for the legal status of abortion and contraception is patientcentric, one of personal and reproductive freedom.123 however, a different rationale exists for promoting the use of stem cell base treatments; not one of personal liberty for the physician, but the profound social good such treatments could offer society and moreover, individual patients. legal, medical, and sociological scholars alike have stated that embryonic stem cells “have the potential to provide a limitless source of specific cell types for transplantation,” organ creation, tissue regeneration, nerve repair, and so on, which could aid in alleviating the “debilitating conditions” of so many persons around the globe. michael brannigan has argued that “[b]ecause the benefits of embryonic stem cell research clearly outweigh the burdens, the moral status of [persons who suffer from debilitating diseases and conditions] clearly [have] priority over the moral status of the early embryo.”124 because the implicated rights are of a different nature and the benefits are so much greater, stem cell based treatments should not be placed in the same category as the traditionally considered services of abortion or sterilization within conscience clauses. while the differences between procedures traditionally included in conscience clauses and potential stem cell based treatments do not dispositively mandate that stem cell based treatments be universally exempt from all conscience clauses, those differences demonstrate, at a minimum, that stem cell based treatments deserve a higher level of consideration than abortion or sterilization in a conscience clause context. v. three possible avenues of expansion of conscience clause protections to include stem cell based treatments if stem cell based treatments deserve a comparatively elevated level of consideration before their inclusion in a conscience clause then an automatic inclusion or an inclusion precipitated by those in the minority would be far less desirable than an explicit decision by the majority. the following 123. see generally roe v. wade, 410 u.s. 113 (1973). 124. sylvia e. simson, breaking barriers, pushing promise: america's need for an embryonic stem cell regulatory scheme, 34 brook. j. int'l l. 531, 542-43 (2009). 492 indiana health law review [vol. 8:2 are three possible avenues that could result in stem cell based treatments being included in conscience clauses. a. overly broad state conscience clauses the most obvious route to the inclusion of stem cell based treatments in conscience clauses, without due consideration, is exemplified by the overly broad state conscience clauses. because these clauses place no limitations on the types of services a health care professional may refuse to provide, stem cell based treatments are arguably already included in such clauses. these open ended conscience clauses, like that of mississippi, could readily be interpreted to allow health care professionals to decline to provide any stem cell derived treatment at all.125 b. legislative expansion of current conscience clauses aside from states which place no limitation on the types of services health care professionals may decline to provide, some states have greatly expanded the traditional scope of conscience clause protections to include “family planning services or referrals . . . assisted reproduction, human cloning, fetal experimentation, euthanasia, and termination of life support.”126 while these newly enumerated services are similar to abortion and sterilization in that they do not promise the level of potential benefits offered by stem cell based treatments, their inclusion in conscience clauses nonetheless demonstrates the willingness of some states to extend the protections of a doctor’s choice to refuse morally objectionable procedures beyond its traditional scope. c. possible “back door” classification of stem cell based treatments as currently enumerated procedures while the majority of conscience clauses enumerate abortion as one of the services that health care providers may decline to provide, only a few actually define the term “abortion.”127 of the states that have taken the care to define the term, most focus on either the end result of a terminated pregnancy or a broad description of the procedure. this reflects intent to restrict the term to its common usage, presumably to prevent its extension to related but distinct terms, like contraception. some statutes even explicitly exempt 125. see miss. code ann. § 41-41-215(5) (west 2009). 126. martha s. swartz, “conscience clauses” or “unconscionable clauses:” personal beliefs versus professional responsibilities, 6 yale j. health pol'y l. & ethics 269, 284 (2006). 127. see, e.g., la. rev. stat. ann. § 40:1299.35.1(1) (2009); see also, e.g., n.d. cent. code § 14.02.1-02(1) (1975); del. code ann. tit. 11, § 654 (1975). 2011] stem cell based treatments and conscience clause legislation 493 things like contraception from the definition.128 because the term “abortion” has a commonly understood meaning,129 such specificity is not required as a practical matter, as evidenced by the abundance of statutory provisions which lack a definition of the term altogether. thus, these explicit omissions might also reveal intent to prevent procedures that are commonly understood not to be abortions (such as the provision of birth control medication, or stem cell based treatments) from being piggybacked onto an overly broad or formalistic definition of abortion. because most of these statutes were drafted and enacted before 1980,130 they do not contain explicit exemptions for stem cell based therapies.131 however, the intent behind preventing an expansion of the term to encompass contraception applies with more or equal force to the inclusion of stem cell treatments. because stem cell based treatments are still in the research phase, there is no case law dealing directly with the classification of such treatments. however, analogous extensions, such as the classification of contraception as abortion, have been attempted and demonstrate essentially the same legal reasoning. one such example is the louisiana case of margaret s. v. edwards.132 in this case the plaintiffs argued that “abortion”,133 defined under the act as “the deliberate termination of a human pregnancy after fertilization of a female ovum, by any person, including the pregnant woman herself with an intention other than to produce a live birth or to remove a dead unborn child” covered two methods of contraception, namely the use of an intrauterine device (“iud”) and the “morning-after pill.”134 the plaintiffs ad 128. mich. comp. laws ann. § 333.17016(5)(a); mich. comp. laws ann. § 333.17516(5)(a) (defining “abortion” as “the intentional use of an instrument, drug, or other substance or device to terminate a woman's pregnancy for a purpose other than to increase the probability of a live birth, to preserve the life or health of the child after live birth, or to remove a dead fetus” and explicitly exempting “the use or prescription of a drug or device intended as a contraceptive.”). 129. see black's law dictionary 6 (8th ed. 2004) (defining abortion as “an artificially induced termination of a pregnancy for the purpose of destroying an embryo or fetus”); see also oxford university press, abortion, oxford dictionaries.com, http://www.askoxford.com/concise_oed/abortion?view=uk (last visited mar. 7, 2011) (defining abortion as “the deliberate termination of a human pregnancy,” or “the natural expulsion of a fetus from the womb before it is able to survive independently.”). 130. see rachel benson gold, the guttmacher report on public policy: conscience makes a comeback in the age of managed care 1 (1998), available at http://www.guttmacher.org/pubs/tgr/01/1/gr010101.pdf (providing that half of the states had their own conscience clause legislation by the end of 1974, and nearly all of the states had enacted their own conscience clause legislation by the end of 1978). 131. see stem cell basics: what are adult stem cells?, supra note 55 (providing that the first successful derivation of human stem cells was not accomplished until 1998, almost twenty years after most states had enacted their conscience clauses). 132. margaret s. v. edwards, 488 f. supp. 181 (e.d. la., 1980). 133. la. rev. stat. ann. § 40:1299.35.1(1) (2009) (stating louisiana’s statutory definition of “abortion” as cited in edwards, 488 f. supp. 181,). 134. edwards, 488 f. supp. at 190-91. 494 indiana health law review [vol. 8:2 vanced this argument in an attempt to show that the act’s definition of abortion was impermissibly vague, since it necessarily included these forms of contraception, which are, in their common usage, not considered forms of abortion.135 in its analysis, the court examined other state statutes dealing with abortion and stated that those statutes were similarly open ended,136 even broader,137 or failed to define the term altogether.138 because any treatment derived from embryonic stem cells necessarily involves destroying the viability of an embryo, such treatments could be construed to fall under the definition of abortion. this construction, while textually permissible, would go against the legislative intent behind conscience clauses with enumerated services.139 vi. proposal most conscience clauses were adopted decades before the average person had ever heard of stem cells and as a result,140 reflect a balance between conscience protection and the potentially objectionable procedures of the time, all of arguably marginal public good. inherent in these clauses is an assumption that patients, for reasons of personal choice, request objectionable procedures. this assumption informs the balance between conscience protection and patient access underlying the purposes of these clauses. in light of this, it is not surprising that most conscience clauses accord greater weight to the health care professional’s right of refusal. however, aside from a few outliers,141 these clauses have stopped short of providing an unqualified right of refusal for any procedure, demonstrating that the competing interests behind abortion and contraception are due at least some consideration. an attempt to balance stem cell based treatments 135. id.; see also black's law dictionary, supra note 129; oxford university press, supra note 129. 136. n.d. cent. code § 14.02.1-02(1) (1975) (defining abortion as “the termination of human pregnancy with an intention other than to produce a live birth or to remove a dead embryo or fetus.”). 137. del. code ann. tit. 11, § 654 (1975) (defining abortion as “an act committed . . . with intent to cause a miscarriage.”). 138. miss. code ann. § 97-3-3 (1997). 139. see 148 cong. rec. h6566-01 (daily ed. sept. 25, 2002) (statement of rep. weldon) (“contraception is not defined by the fda as abortion. the morning-after pill is not defined by the fda as abortion. it is defined as contraception. it is something different. so to interpret this statute to claim that it is going to prohibit access is to take essentially a religious entity’s doctrine and put that into the statute, and it is just not there. it is not in the language.”). 140. see stem cell basics: intro, supra note 56 (providing that the first successful derivation of human stem cells was not accomplished until 1998); see also gold, supra note 130 (providing that half of the states had their own conscience clause legislation by the end of 1974, and nearly all of the states had enacted their own conscience clause legislation by the end of 1978). 141. miss. code ann. § 41-41-215 (1998). 2011] stem cell based treatments and conscience clause legislation 495 within the confines of current conscience clauses might well produce results that do not accurately reflect public opinion and were never contemplated at the time the clause was created. a. explicit and proactive reconsideration by legislators of how current conscience clauses would apply to stem cell based treatments legislatures are beholden to the will of their constituents and this author is in no position to tell them how to balance the competing interests behind their conscience clauses. while this author believes that excluding stem cell based treatments from conscience protection is the best course of action, even an explicit inclusion is preferable to leaving the question unresolved. the mere act of proactively and consciously addressing the issue would provide benefits for both health care professionals and patients and is much preferred to the consequences likely to result from inaction. b. the benefits of explicit and proactive reconsideration 1. a more accurate reflection of public opinion in the absence of clear legislative consideration regarding stem cell based treatments, their inclusion or exclusion will be a matter of statutory interpretation determined by the courts. legislatures are in a much better position to accurately gauge the opinions of their constituents and reach a decision based on that input. 2. clarification of the law, removal of uncertainty without guidance on whether or not a health care professional may decline to provide a stem cell based treatment, many such professionals may perform these procedures against their moral convictions out of fear of legal liability. conversely, health care professionals who do decline to provide these procedures may end up liable themselves. 3. proper balancing of right of refusal and patient access lastly, only the legislature is positioned to freely balance the right of conscience protection for health care professionals against the right of access to care for patients. the unstated assumption in most conscience clauses (that there is minimal public good created by the traditionally included procedures) does not hold for stem cell based treatments. the status of stem cell based treatments is a novel issue, largely unaddressed by current conscience clauses. going forward, legislatures are in the best position to change the existing law in order to recognize this fact. 496 indiana health law review [vol. 8:2 vii. conclusion conscience clauses were originally created for the narrow purpose of protecting health care professionals who were morally or religiously opposed to performing abortions. because the moral objections behind the use of embryonic stem cells are typically rooted in the same principles, these treatments are at risk of being classified with the services typically included in conscience clauses, despite the numerous differences between them. it would be prudent for legislatures to prospectively examine how their current conscience clause statutes might apply to stem cell based treatments. these conscience clauses should be clarified to explicitly include or exclude stem cell based treatments now, before the impending proliferation of such treatments. failure to do so will result in confusion, a wave of litigation, and potential outcomes that were neither intended by legislative drafters nor accurate reflections of public opinion. wilham h. thompsoa bill thompson is president and managing partner of the law firm of hall, render, killian, heath & lyman, p.c., practicing in the area of health care law. mr. thompson concentrates his practice on financial relationships among health care providers, including hospitals and physicians. mr. thompson also provides advice and counsel regarding managed care and integrated delivery systems, and state and federal health care regulatory matters, including fraud and abuse, stark n, licensure, antitrust, and compliance issues. representative clients include hospitals and health care systems, individual physicians and medical groups, managed care organizations, and physician practice management companies. mr. thompson received his bachelor of science degree, master's degree in health administration, and doctorate of jurisprudence from indiana university. he is the past chair of the healthcare & medicine section of the indiana state bar association and is a member of the american bar association, the american health lawyers association, and the american college of healthcare executives. he is named in the best lawyers in america under the health care section. mr. thompson has served as a frequent speaker on topics dealing with health care issues and has authored a variety of articles on health law topics. aligning hospital and physician incentives in the era of pay-for-performance william h. thompson, esq. • i. introduction known variously as pay-for-performance, pay-for-quality, or quality contracting, these reimbursement models tie provider payments to patient care as measured· by specific criteria, such as clinical process standards, patient satisfaction, patient outcomes, deployment of information technology, and a host of other measures. there are now a number of initiatives underway by commercial insurers, the medicare and medicaid programs, employers, and other payers of health care services based on pay-for-performance principles. this payment methodology is a radical change from the current system of reimbursement, which is best described as payment for inputs regardless of the outcomes. the pay-for-performance ("p4pj movement is the latest in a long and difficult search for a rational system to reimburse hospitals, physicians, and other providers of health care services. so, what is a hospital to do in the face of an emerging system of reimbursement that is going to be based increasingly upon quality outcomes, efficiency measures, deployment of information technology, and patient satisfaction; particularly when the hospital has little direct ®ntrol of the care processes and decisions that affect such measures? this dilemma was summarized well by dr. charles peck: physicians and hospitals collectively suffer . from "mural dyslexia,". characterized by an inability to read the handwriting on the wall. the haiidwriting ·is indeed clear. to survive, hospitals must collaborate with doctors because the most expensive piece of medical technology is the physician's pen. in turn, to survive, doctors must collaborate with someone, and the hospital remains the natural partner.1 to be sure, hospitals should seek to align incentives with their physicians and other providers in order to maximize their success under a reimbursement system based on pay-for-performance principles. this alignment is easier said • william h. thompson, esq. is the president and managing partner of hall, render, killian, heath & lyman, p .c., a law firm with offices in indianapolis, detroit, louisville, and milwaukee. hall render concentrates its practice on the representation ofhealth care providers including hospitals, health systems, and physicians. 1. charles a peck, the enterprise circle, physician executive, jan. 2001. 328 indiana healm law review [vol. 3:325 than done. however, the effort should not be futile. regardless of the payment system, initiatives aimed at improving quality outcomes, patient safety, and efficiencies are noble in purpose and worthy of pursuit. it is about time that sound clinical practice drives the reimbursement system, instead of the other way around. this article will explore several hospital/physician alignment strategies and the legal and policy considerations that must be addressed in the new world order of pay-for-performance. it. ··the advent of pay-for-performance the vast majority of the united states private and governmental reimbursement systems are structured on the basis of separate payments to each provider involved in the care of a patient under these systems, the physician receives payment for his or her professional services based on a fee schedule. for example, the doctor is paid on inputs and the hospital receives payment for its services based on a diagnosis-related group, per diem, case rate, or percent of charges for inpatient and outpatient services. thus, the more care given to the patient, generally the more reimbursement received. the rehab provider in turn is paid separately, as is the home health care provider, and so on. there is little rationale behind this payment system with regard to an episode or continuum of care, even though the outcome of each provider's efforts, with regard to such care, is largely interdependent upon the efforts of the other providers involved in the patient's care. under today's system of reimbursement, "coordination of care across the continuum," as it is commonly referred, is a principle that largely rings hollow. 2 financial incentives are geared more toward treating symptoms than controlling diseases (particularly chronic diseases) or achieving favorable outcomes. 3 the p4p movement may provide an opportunity to rationalize payment and outcome. pay-for-performance initiatives will not solve all (or any?) of the ills of our american health care system. it may, however, be an experiment worth trying. in 2001, in the report crossing the quality chasm: a new health system for the 21st century, the institute ofmedicine ("10m") called upon health system stakeholders to develop new payment systems that align providers' incentives with the goal of quality improvement.4 this request was in part a response to a previous 10m report published in 1999, toe" is human: building a safer health system, which focused on patient safety.5 one of the 10m's recommendations for transforming health care quality in the 2. see paul krugman, first, do more h01'11j, n.y. dmes, jan. 16, 2006, at al5. 3. id. 4. inst. of med., crossing the quauty chasm: a new healm system for the 21st century (2001) [hereinafter crossing the quautychasm). 5. inst.ofmed., toerrishuman:bunl>ingasaferhealtiisystem{l999). 2006] allgnjng hospital and physician incentives 329 united states is to align payment policies with quality improvement. this recommendation calls for "all purchasers, both public and private to carefully reexamine their payment policies to remove barriers .that impede quality improvement and to build in stronger incentives for quality·enhancement.'16 the 10m's crossing the quality chasm7 makes clear the need for a systematic and radical overhaul of health care. furthermore, there is a growing consensus that quality can no longer be ignored when it comes to provider payment. advocates believe that the future of the american health care system is dependent upon a payment system that measures, compares, and rewards performance, not in terms of the number or complexity of services rendered, but instead on the basis of the quality and efficiency of such services.8 the concept of paying providers for performance (however measured) is being explored and implemented by both private and governmental payers alike. the medicare payment advisory commission ("medp ac''), an advisory arm of the united states congress, advocated in june, 2003 that medicare begin using incentives to. improve the quality of health care.9 medp ac recommended that a pay-for-performance system in medicare begin with health plans and rehabilitation facilities because they have the history and capacity to collect and publicly report the quality data necessary for performance measurement.10 medp ac has elaborated on its recommendations in subsequent reports and testimony before .the house ways and means committee: current payment systems in medicare are at best neutral and at worst negative toward qu81ity. all pro~ders meeting basic requirements are paid the same regardless of the quality of service provided. at times providers ~ j)aid even more when quality is worse, such as when co~lications occur as a result of error .. it is time for medicare to take the next step in quality improvement and put financial incentives for quality directly into its payment systems.11 consistentwithmedpac'srecommendations,thecentersformedicare and medicaid services ("cms'') has embarked on a number of demonstration 6. crossing 1lie quauty chasm, supra note 4. 1./d. 8. jack ebeler, american bar ~on teleconference discussing paying for performance to improve healthcare (may 2, 2005) (transcript on file with author). 9. medi~payment advisor.ycommjsslon,repolttt01liec0ngress: variation and innovation in medicare (2003). lo.id. 11. improving quality through .metlictjie qlf(/ payment policy: hf!flring before the subcomm. on health comm. on wop qlf(/ meons, u.s. house of representatives, (mar. 18, 2004)(statementofglenn m. hackbertb, cbairmanmedican:paymeotadvisorycommission). 330 indiana health law review [vol. 3:325 projects and pilot programs concerning pay-for-performance programs.12 these programs include: • premier hospital quality incentive demonstration. • physician group practice demonstration. • medicare care management performance ·demonstration. • medicare health care quality demonstration. • chronic care improvement program. • disease management demonstration for severely chronically lll medicare beneficiaries. • disease management demonstration for chronically dl dual-eligible beneficiaries. • end stage renal disease (esrd) management demonstration. • care management demonstration for high cost beneficiaries. 13 a component of each of these demonstration projects is the adoption of standard quality measures to support better care coordination and continuity for beneficiaries with chronic or acute illnesses across different settings.14 each project is piloting various payment reforms to reward providers for better quality, better patient satisfaction, and lower overall costs.15 the number and scope of these demonstration projects is indicative of cms' desire to revamp the medicare program in an attempt to reconcile payment and quality. private insurers ofhealth care services are also embarking on reimburse­ ment programs that attach payment to certain measures of care. these programs range in scope from national initiatives underwritten by private foundations, such as the "rewarding results" program funded in part by the robert wood johnson foundation, which is intended to assess and develop innovative reimbursement models to single payer efforts with less ambitious goals of securing the bottom line!6 there is, however, one aspect that is common to all private p4p programs: the objective of assisting purchasers of 12. see enclosure 3 ofletter from mark b. mccleuan, adm'r ofctrs. for medicare and medicaid servs., to william m. thomas, chairman ofways and means comm., u.s. house of representatives (june 24, 2005). 13. ld. 14. id 15. !d. 16. see leap frog group, http://www.leapftoggroup.orgir.ewardingresults/index.htm (last visited mar. 6, 2006) (for an overview of rewarding results, which is a privately funded $8.8 million national pay• for-performance project with many types ofhealth care providers and payers). 2006] augning hospital and physician incentives 331 health care and health plans to align incentives for high-quality health care.17 the prevalence ofp4p programs in the private sector depends in part upon geography; but based on a recent survey by medical economics, it is clear that a number of commercial insurance companies are implementing pay-for-performance measures in their health services contracts. 18 advocacy groups for insurance companies and other payers ofhealth care services have also endorsed the p4p principles, including the leapfrog group, bridges to excellence, and the integrated healthcare association.19 no doubt, private insurers will continue to push pay-for-performance programs as long as the data shows these programs result in reduced costs and better care to their insureds. as the national debate intensifies over pay-for-performance programs, many professional societies and accrediting bodies have weighed in with their views and proposed standards. for example, the joint commission on accreditation of healthcare organizations ("jcaho'') has set forth ten principles that it offers ''to guide the development and refinement of current and pay-for-performance programs. "20 these principles are applicable to p4p programs initiated by payers as well as to hospitaj/physician alignment strategies that are aimed at incentivizing improved quality and patient safety. the principles are as follows: • the goal of pay-for-performance programs should be to align reimbursement with the practice of high quality, safe health care for all consumers. • programs should include a mix of fmancial and non-financial incentives (such as differential intensity of oversight; reduction of administrative and regulatory burdens; and public acknowledgment of performance) that are designed to achieve program goals. • when selecting the areas of clinical focus, programs . should strongly consider consistency with national and regional efforts in order to leverage change and reduce conflicting or competing measurement. it is also important to attend to clinical areas that show signifi­ cant promise for achieving improvements because they 17. id. 18. ken teny, pay-for-performance: how fast is it spreading?, med. econ., nov. 4, 2005; see also pay for performance works, says cms ... but challenges persist, says study, j. healtiicarefin.mgmt.,jan. 2006, at 17-20 [hereinafter pay for performance works]. 19. pay for performance worb,supranote 18. 20. joint commission on accreditation of healthcare organizations, principles for the construct of pay-for-performance programs, http:/lwww.jcaho.orglabout+us/public+policy +initiatives/pay _for _performance.htm (last visited mar. 6, 2006). 332 indiana·iieal111 law review [vol. 3:325 represent areas . where unwarranted differences in performance have been documented. • programs should be designed to ensure that metrics upon which incentive payments are based are credible, valid and reliable. • programs must be designed to acknowledge the united approach necessary to effect sigliificantcbange, and the reality that the provision of safe, high quality care is a shared responsibility between provider organizations and health care professionals. • the measurement and reward ftamework should be strategically designed to permit and facilitate broad­ scale behavior change and achievement of performance goals within targeted time periods. to accomplish this, providers and piactitioner8 should receive timely feedback about their performance and be provided the opportunity for dialogue when appropriate. rewards should follow closely upon the achievement of performance. • programs should reward accreditation, or have an equivalent mechanism.· that recognizes health care organizations' continuous attention to all clinical and support systems and processes that relate to patient safety and health care quality. • incentive programs should support .an interconnected health care· system and the implementation of "interoperable" standards for collecting, transmitting and reporting information. • programs should incorporate periodic, objective assessment into their structure. the evaluations should include the system of payment and incentives built into the program design, in order to evaluate its effects on achieving improvements in quality, including any unintended consequences. the program and, where appropriate, its performance thresholds should be re-adjusted as necessary. • provisions should be made to invest in sub-threshold performers who are committed to improvement and are willing to work themselves or with assistance to develop and cany out improvement plans. such invest­ ments should. be made after considering both the potential for realistic gains in improvement relative to the amount of resources necessary to achieve that 2006] aligning hospital and physician incentives promise, and what is a reasonable timeframe for achieving program performance goals. 21 333 the american medical association ("ama") has not, by any means, endorsed the concept of pay-for-performance programs, particularly because of the budget-neutral aspect of such programs for governmental patients. at its june 2005 annual meeting, the ama house of delegates adopted a resolution regarding p4p programs that includes the following principles: • ensure quality of care. • foster the relationship between patient and physician. • offer voluntary physician participation. • use accurate data and fair reporting. • provide fair and equitable program incentives. 22 the ama continues to be concerned about the myriad of measurements being proposed under private and governmental p4p programs, the cost to physician practices to operate under such programs (particularly the necessary investment in information technology), and the potential for such programs to interfere with the patient-physician relationship.23 iii. hospitaiiphysician alignment strategies it is evident that the p4p initiatives are going to intensify at the payer level. for any health care system to be successful under this type of reimbursement system, it must have a coordinated approach to the delivery of health care services. these efforts must involve the hospital medical staff. this realization is neither revolutionary nor novel. however, for a number of reasons (a lack of aligned incentives being one of the greatest), efforts to coordinate care around improved quality, patient safety, and efficiency have fallen short of their potential. increasingly, hospitals and their affiliated physicians are embarking on a number of alignment strategies aimed at these goals. motivations vary-fmancial, competitive, market share, reputation­ but one key driver of these alignment efforts is to prepare the health system for payment based increasingly on objective measures of performance. among others, these hospitavphysician alignment strategies include ancillary service joint ventures, clinical service line management arrangements, participating bond transactions, gainsharing, clinical integration, and physician employment while none of these strategies is necessarily new, 21. ld 22. american medical association house of delegates, pay for peiformance initiatives and physicians who serve minority patient populations, res. 218 (a-05) (may 11, 2005). 23./d. 334 indiana health law review [vol. 3:325 what is encouraging is that the financial incentives associated with each is being increasingly focused on quality outcomes, patient safety, and efficiency supported significantly by the deployment of cutting-edge information technology. no one size fits all and what works in one institution may not work in another. but those hospitals and physicians who accept the status quo may lose out on the benefits a p4p system can yield. the goals of any hospital/physician alignment strategy will vary, but they can be fairly summarized as follows: • to create an opportunity for the physicians to be more involved in the control, governance, management, and overall decision-making processes with regard to both the operational and clinical aspects of a particular clinical service line. • to align clinical, operational, and financial incentives among the physicians, the hospital, and other caregivers. • to focus on those processes of care that have the greatest impact on quality, patient safety, and efficiency. • to distinguish the providers in the marketplace. • to obtain measurable and objective improvements in quality, patient safety, and efficiency. • to facilitate the acquisition and deployment of information systems that support the goals· of the alignment strategy. several alignment strategies designed to accomplish these goals are discussed in briefbelow. a. participating bond transactions unlike traditional fixed-interest, tax -exempt bonds, participating bond transactions ("pbts") involve the sale of participating instruments. this means that the bondholders share in the success or failure of the venture financed by the participating bonds. some of these bonds are sold to physicians associated with the venture, while others are sold to institutional investors. for example, a hospital may issue participating bonds to partially finance the construction of a new imaging center or ambulatory surgery center (''asc''). a portion of these bonds would be made available for purchase by members of the hospital's medical staff that meet certain pre-established criteria unrelated to the volume or value of referrals the physicians may make to the new venture .. the rest of the bonds would be sold on the open market. the participating bonds would pay the investors based on the economic performance of the imaging center or asc. if performance is poor in a given 2006] augning hospital and physician incentives 335 year, holders of participating bonds might receive little or no interest for that year. on the other hand, if the venture performs well (i.e., to the pre­ established financial targets), interest is paid to the bondholders. thus, the bondholders are motivated to ensure the success of the venture. participating bonds are often subordinated obligations, meaning that the participating bondholders will not be paid until all obligations have been met to the senior bondholders. as a result of the subordinated nature of the bonds and the risk that the venture will not meet the pre-established financial standards, the interest rate on participating bonds is generally higher than that available on traditional fixed-interest bonds. these rates can be in the range of twelve percent to fifteen percent on a tax-free basis.24 germane to p4p principles, participating bond transactions can be structured in a manner such that the triggers pertaining to the payment of interest on the bonds go beyond those that are economic in nature to those that relate to the quality of care and/or efficiency of a particular service. in the context of an asc, these triggers could include patient satisfaction, on-time starts, infection rates, medication errors, returns to surgery, and other similar measures. accordingly, the physician bondholders who also use or refer patients to the center are incentivized to achieve not only economic results, but also results related to quality or efficiency in order to ensure the payment of interest on the bonds. b. clinical integration clinical integration is a concept arising out of the application of the antitrust laws to provider networlcs and their contracting activities. federal and state antitrust laws have long recognized financial integration as a means for health care providers to engage in joint negotiations over prices with health plans without being condemned as per se illegal horizontal price-fixing. 2s financial in~gration can be achieved in a number of ways, including merger, substantial risk-sharing, and other means that create a "unity of interest" among the participants in the integration efforts. 26 according to certain joint policy statements issued by the federal trade commission ("ftc") and the department of justice ("ooj"), sufficiently clinically integrated physician networks for antitrust purposes are treated in the same fashion as financially integrated networks. 27 24. thomas ryan & robert rosenfield, special reporl: a "carrot" and "stick" approach to improve physician-hospital ridations, governanceinst. 7 (2003). 25. see generally department of justice and federal trade commission statements of antitrust enforcement policy in heahhcare, wash. reg. reporting associates, aug. 28 1996 [hereinafter ftc]. 26. copperweld corp. v. independence tube corp., 467 u.s. 152, 771 (1984). 27. ftc, aupra note 25, at statement 8. 336 indiana health law review [vol. 3:325 specifically,· statement eight of the policy statements explains that sufficient clinical integration, absent economic risk-sharing, "can be evidenced by the network implementing an active and ongoing program to evaluate and modify practice patterns by the network's physician participants and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality."28 the statement goes on to state that such a program may include: • establishing mechanisms to monitor and control utilization· of health care. services that are designed to control costs and assure quality of care; • selectively choosing network physicians who are likely to further these. efficiency objectives; and • the significant investment of capital, both monetary and · human, in the necessary infrastructure and capability to realize the claimed efficiencies. 29 clinically integrating a group of otherwise independent physicians or other health care providers to the degree sufficient to pass muster under the antitrust ·laws is no easy matter. to date, the ffc has issued only one advisory opinion approving a proposed clinical integration model. 30 even so, while the ability to jointly negotiate managed care contracts is one benefit of a fully clinically integrated model, networks falling short of this degree of integration can still follow the ffc or the ooj's guidance in an effort to better coordinate ci.re and control quality, without necessarilyjointlynegotiat­ ing payer contracts. in other words, the underlying concepts of clinical integration dovetail nicely with those of the pay-for-performance movement and are responsive to the health care market. hospitals and health systems may be able to play a significant role in encouraging and facilitating clinical integration among their physicians and other affiliated providers. these efforts may include education, information technology support, care mailagemeilt staff, data collection and analysis, clinical protocol development, electronic medical record, credentialing, consulting, and legal support. 28. ld;see also robertf; lei'benluft & tracy e. weir, clinical integration: assessing the antitrust issues (feb. 8, 2006) (unpublished conference;held by physicians and physician organizations law institute). 29. leibenluft & weir, supra note 25, .at 9. · 30. see letter &omjetji'ey w. brennan, assistantdir. health care servs. & prods., ftc, to john j. miles; principal at ober, kaler, grimes & shriver (feb. 19, 2002), at http://www.ftc.govjbc/adopslmedsouth.htm (last visited mar. 25, 2006). 2006] augning hosprral and physician incentives 337 c employment in the late eighties and early nineties, there was significant activity among hospitals, health systems, and physician practice management companies ("ppms") with regard to the acquisition of physician practices, predominantly primary care practices. here, the hospital, health system or ppm would acquire all, or substantially all, of the tangible and intangible assets of the practice, and subsequently enter into employment agreements with the selling physicians. these transactions were largely in response to the managed care movement occuning at the time. common wisdom held that those health care systems. with ·the largest number of primary care doctors available to serve as gatekeepers and managers of care· would be the most attractive to managed care companies looking for a network that could either provide health care services on a capitated or some other risk-sharing basis. a number of lessons have been learned with regard to the physician employment model, particularly the. importance of productivity-driven compensation systems and the recognition that administrators do not make clinical decisions, rather physicians do. also, risk-based contracting, particularly fully capitated arrangements, has not· gained the m8rket prevalence first predicted. nonetheless, the employment model continues to be effective today for a number of hospitals as a means to integrate hospital and physician services, including the increased prevalence of the employment of specialty physicians. as the employer, hospitals may have increased flexibility with regard to implementing and incentivizing certain quality and efficiency standards among its employed physicians, such as the adoption of clinical protocols and other common processes across the continuum of care. the employment contract can be used to require and incentivize physicians to coordinate and manage care processes in accordance with those pay-for-performance standards incorporated into the payer contracts held by the hospital. also, financing the acquisition and deplo}'ment of useful technologies may be more easily achieved under an employment model as compared to implementing these initiatives among a disparate group of independent physicians. d. ancillary service joint ventures ancillary service joint ventures can take a number of forms and encompass a variety of services. historically,jointventures between hospitals and doctors focused on outpatient services, such as i~g and diagnostic centers, cardiac catheterization laboratories, ambulatory surgery centers, and the like. recently, there has been a proliferation of joint ventures aimed at the 338 indiana healm law review [vol. 3:325 joint ownership of licensed hospitals, particularly specialty hospitals (e.g., heart and orthopedic bospitals).31 the benefits ofhospitavphysician ancillary service joint ventures can be significant. through an affiliation with physicians, the hospital secures the opportunity to expand its services in high-growth areas and also increases collaboration and trust with its physician-partners. similarly, these joint ventures give physicians the opportunity to diversify their income streams and to gain more significant control over both the operational and clinical aspects of the joint-ventured service. it . is this latter benefit that provides an opportunity to align economic incentives around the pay-for-performance principles of quality, patient satisfaction, and patient safety. to the degree the financial success of the joint venture is tied to certain quality, efficiency, or patient safety standards, the more vested the physician-owners will be in ensuring that these standards are met. e. clinical service line management arrangements this model entails the management of a hospital's entire clinical service line by a particular group of physicians or a new company jointly owned by the hospital and certain physicians formed for that purpose. the underlying concept is the delegation to the physician-managers of significantly more authority with respect .to both the operational and clinical aspects of the service line, particularly those aspects that the physicians can control or significantly influence . . the principal elements of a service line management arrangement are as follows: • an independent analysis is conducted of a particular clinical service line of the hospital to identify areas of improvement in terms of clinical inputs, clinical outcomes, patient safety, efficiencies, information technology, and patient satisfaction. • the hospital and physicians' current performance with regard to these areas are benchmarked against local, regional, and national statistics to identify the range of improvement opportunities. • specific areas of improvement that are measurable, objective, and largely under the control of the 31. a regulatory exception exists under the stark statute, commonly referred to as the "whole hospital exception." 42 c.f.r. § 4ll.356(c)(3) (2006). this exception permits a physician with an ownership interest in a hospital to make referrals to that particular hospital providing the referring physician is authorized to perform services at the hospital. /d. however, : ,, the physician's ownership or investment interest must be in the hospital as a whole and not merely in a distinct part or department of the hospital. id 2006] aligning hospital and physician incentives physicians are identified and agreed upon as the areas of focus. these standards may be related to p4p measurements contained in particular payer contracts or related solely to hospital-specific goals with respect to quality and efficiency improvements. • a management services or performance improvement agreement is entered into between the hospital and a particular physician specialty group · or the joint-ventured management company. this agreement sets forth in detail the management obligations and performance standards expected. • compensation is structured based on a oombination of a base management fee for general· service line management services, and incentive compensation tied to the targeted performance standards. • an independent valuation firm is engaged to opine as to the fair market value range of the compensation for the scope of services to be provided, including the general management services and the performance standards. • the company is operationalized and performance standards are reviewed and revised periodically over the term of the arrangement 339 the service line management model creates an effective forum for hospitals and physicians to work together to improve care based on agreed upon objective measures of performance with the added benefit of a financial upside for positive improvement. these attributes are responsive to underlying principles ofp4p programs. f. gainsharing gainsharing is a concept that has garnered a lot of attention lately as a means of aligning hospital and physician incentives around cost-savings. generally, gainsharing programs provide payments to physicians of a portion of the hospital's cost-savings resulting from the physicians' efforts in changing care processes, reducing waste, increasing efficiencies, and/or standardizing supplies. these types of programs have been popular with regard to high-cost service lines, such as cardiac and vascular care, orthope­ dics, and oncology. for example, a hospital could design a gainsharing program around the standardization of the number and variety of drug eluting stents used in cardiac surgery. to the extent such standardization results in a cost-savings to the hospital as measured against a baseline, a portion ofsuch cost-savings would be paid directly to those physicians that participated in the standardization process. the inspector general of the department of health 340 indiana heal1h law review [vol. 3:325 and human services (''010") bas long been concerned that these types of programs may adversely affect the care provided to medicare beneficiaries. the 010 issued a special advisory bulletin in july 1999 that stated that certain hospital/physician gainsharing arrangements violate the civil monetary penalties law ("cmp") by improperly inducing physicians to reduce the level of care provided to patients.32 according to the 010, such arrangements marketed only to physicians in a position to refer patients may induce investor-physicians to limit patient services. this incentive is created by permitting the physician a percentage of profits generated by cost savings in clinical care and thus could violate the cmp "in at least some circumstances" and may implicate the federal anti-kickback statute.33 more specifically, the 010 stated that "any hospital incentive plan that encourages physicians through payments to reduce or limit clinical services directly or indirectly violates the statute." adding later in that same special advisory bulletin, the cmp "prohibits any hospital-physician incentive plan that compensates a physician directly or indirectly based on cost savings on items and services furnished to patiellts under the. physician's clinical care.,'34 however, the 010 noted the following: [h]ospitals may align incentives with physicians to achieve cost savings through means that do not violate [the cmp]. for example, hospitals and physicians may enter into · personal services contracts where hospitals pay physicians based on a fixed fee that is fair market value for services rendered, rather than a percentage of cost savings. such contracts must meet the requirements of the anti-kickback statute. 35 · in an about-face, the 010 formally approved a hospital cost-saving program in january 2001 that compensated cardiac surgeons for certain supply cost savings.36 also, in february 2005, the. 010 approved six similar cost-savings programs related to hospitals' cardiac surgery and cardiology programs.37 even though the oig believed these programs might incentivize the limitation or reduction of services to beneficiaries, it found enough 32. dep't health and hum. selt.vs., oig, special advisory bulletin, gainsharing ~ts and cmps for. hospital payments to physiciads to reduce or umit services to bendiciaries (1999). 33. id at section b~ 34. id.. at section d. 3s.jd . 36. oig, dep't health& hum. selt.vs., advisory opinion no. 01-01 (2001 ), available at http://oig.hbs.gov/ftaudlac:lvisocyopinions.html (last visited mar. 25, 2006). 37. oig, dep't health & hum. servs., advisory opinion no. 05-01 (200s), 05-02 (200s), os-03 (200s), os-04 (200s), os-os (200s), and os-06 (2005), available at http://oig.hbs.gov/ftaud/advisoryopinions.btml (last visited mar. 2s, 2006). 2006] aligning hospital and physicjan incentives 341 safeguards to approve the programs for those providers seeking the 010•s opinion. thus, the 010 will look to the operation of the program to determine whether or not it violates the terms ofthe statute. 38 medpac recently released a.draft recommendatiqn to congress that, among other things, addressed gainsharing arrangements between physicians and hospitals. 39 medp ac stated that it believes that gainsharing could better align hospital and physician financial incentives and could be structured to have fewer risks than outright physician ·ownership of hospitals. while medpac acknowledged concerns with gainsharing, including the oio's concerns that gainsharing arrangements could violate the cmp, it indicated that hhs could be provided the statutory authority to develop protections to ensure that gainsharing arrangements do not harm the q1iality of patient care, while at the same time aligning financial incentives. <lei finally, the deficit reduction act of 2005 contains a provision authorizing a gainsharingdemonstration project:" this provision requires the secretary to approve gainsharing demonstration projects by november 1, 2006. the secretary would ,be required to test and evaluate methodologies and arrangements between hospitals and physicians. oainsharing was originally designed to govern the utilization of inpatient hospital resources and physician work to implove the quality and efficiency of care provided to medicare beneficiaries ..00 to develop improved operational and financial hospital performance with sharing of remuneration as specified in the prc)ject. the secretary is to apprqve not more than six of these projects, at least two of which must be located ill rural areas.42 . by their nature, gainsharing. programs are focused almost entirely on cost-savings, not quality or efficiencies; although cost, quality and efficiencies are not necessarily mutually exclusive •. as such, the responsiveness of these types of programs to p4p principles is debatable; but success in incentivizing savings for the hospital is still significant. iv. legal considerations. there exists a labyrinth of state and federal laws that impact the ability of hospitals and physicians to align incentives around pay-for-performance principles. economic relationships among providers of care in positions to refer patients to one another are heavily regulated. state and federal 38. medpa.c report to congress: medicore paymeni pq/icy: hearing before the subcomm. on health comm. on ways and means, u.s; houseoj'representatives(oc:t. 1, 2005) (statement of lewis morris, chief counsel to the inspector gen., dep't health&: hum. servs.) (on file with author). 39. mbdpac report to the congress: medicare payment poucy 183-90 (2005). 40./d. 41. deficit reduction act of2005, pub. l no. 1~171, § s007 (2006). 42./d . 342 indianaheal1h law review [vol. 3:325 governments are concerned that these types of relationships can corrupt sound medical judgment and subordinate patients' best interests to the providers' economic interest. a review of each federal and state law and regulation applicable to hospitavphysician alignment strategies is beyond the scope of this article. however, a brief analysis of several of the more pertinent federal laws impacting economic relationships among hospitals and physicians is instructive as one tries to navigate the murky waters of hospital-physician relationships. a. civil monetary penalties law the federal civil monetary penalties law ("cmp'') prohibits a health care provider from knowingly making a payment, directly or indirectly, to a physician as an inducement to reduce or limit services to medicare or medicaid patients under the physician's direct care.43 violations of the cmp can result in civil monetary penalties of $2,000 per patient against both the hospital and the physician. 44 this statute is broadly written and does not distinguish financial incentives to limit medically necessary services from financial incentives to limit medically unnecessary services. thus, by a literal interpretation of the statute, hospitals are prohibited from incentivizing physicians financially to reduce waste, excessive lengths of stay, or overutilization of supplies or· services. this seemingly contradictory prohibition is a large impediment for any hospital that is trying to respond to the federal government's mantra of increased quality and decreased costs. as stated above, it is the cmpthat prohibits gainsharing programs since such programs, on their face, are attempts to generate cost-savings through the reduction of a service or supply. the cmp prohibits such cost-saving efforts even where the service or supply is winecessary, wasteful, or ineffective. the oig has acknowledged this result; but until congress chooses to amend the cmp law, the ability for hospitals to incentivize their physicians financially to reduce waste may be limited. b. anti-kickback statute the federal anti-kickback statute makes it a felony to knowingly and willfully offer, pay, solicit or receive remuneration, directly or indirectly, in order to induce business that is reimbursable under any federal health care program. 45 violation of these provisions may result in imprisonment for up to five years and fines of up to $250,000 in the case of individuals, and 43. 42 u.s.c. § 1320a(b) (2006). 44. /d. 45. 42 u.s.c. § 1320a-7b(b)(2006). 2006] aligning hospital and physician incentives 343 $500,000 in the case of organizations.46 convictions under the anti-kickback statute result itt mandatory exclusion from federal health care programs for a minimum of five years. in addition, the department of health and human· services has the authority to impose civil assessments and fines and to exclude health care providers and others engaged in prohibited activities from the federal health care programs for not less than five years.47 generally, courts broadly interpret the scope of the anti-kickb8ck statute, holding that the statute may be violated if merely one purpose of a payment arrangement is to induce referrals.48 congress has required that the department of health and human services issue regulations establishing a number of"safe harbors" under the anti-kickback statute. these regulations would include payment practices in the health care industry, which practices will not be treated as violations of the anti-kickback statute, or provide the basis for exclusion from federal health care programs.49 an arrangement must fully comply with each and every element of an applicable safe harbor in order to qualify for protection. 50 however, the mere failure of an arrangement to qualify for safe harbor protection does not mean that the arrangement violates the anti-kickback statute; it simply means that such arrangement will be reviewed within the context of the statute to determine if the requisite intent is present to pay or receive remuneration in exchange for referrals. 51 the anti-kickback statute is not generally applicable to p4p programs between providers and payers since there is no referral relationship between these parties. the anti-kickback statute, however, is implicated within the context of many hospital/physician alignntem.t strategies on two levels. first, many alignment strategies result in a flow of funds from the hospital to the physicians participating in the strategy, the same physicians that are referral sources for the hospital. the government is suspicious that such payments are merely disguised payments for referrals, not for quality improvement, efficiencies, or other objectives of the alignment model. 52 secondly, many alignment strategies involve the formation of a new company owned jointly by the hospital and the participating physicians. the investment interests held by the hospital and the physicians in these companies and the resultant 46. jd. 47. jd. 48. see united states v. greber, 760 f.2d 68 (3d cir. 1985). 49. 42 c.f.r. § 1001.952 (2005). 50./d 51. see61 fed. reg. 2,122,2,124(jan. 25, 1996)(tobecodifiedat42c.f.r. pt. 1001); see also oig, dep't healtii 8i. hum. servs., advisory opinion no. 04-19 (2004), for a representative explanation by the office of the inspector general stating that filets and circumstances are evaluated when an arrangement does not qualify for safe harbor protection. 52. supplemental program guidance for hospitals, 7.0 fed. reg. 4858 (jan. 31, 2005); see also oig, dep't. health & hum. servs. special advisory bulletin, contractual joint ventures (april2003). 344 indiana health law review [vol. 3:325 distributions create another level of remuneration among referral sources that is governed by the anti-kickback statute. a participant in a hospital/physician alignment strategy (or other relationships among referral sources involving remuneration of any kind} may request an opinion of the 010 as to whether the 010 would pursue a prosecution of the arrangement as a result of its failure to meet each and every element of the applicable safe harbors. 53 such an advisory opinion is the only sure way to protect arrangements that are not otherwise afforded safe harbor protection. c. starklaw the federal stark law prohibits a physician who has a financial relationship with an entity (including hospitals} that provides "designated health services" from referring federal health care program patients to such entity for the furnishing of such services, with limited exceptions. 54 the stark law also prohibits the entity receiving the referral from filing a claim or billing for the services arising out of the prohibited referral. the prohibition applies regardless of the reasons for the financial relationship and the referral; that is, unlike the federal anti-kickback statute, no finding of intent to violate the law is required. sanctions for violation of the stark law include denial of payment for the services provided in violation of the prohibition, refunds of amounts collected in violations, a civil penalty of up to $15,000 for each service arising out of the prohibited refe~ exclusion from the federal health care programs, and a civil penalty of up to $100,000 against parties that enter into a scheme to circumvent the stark law's prohibition. ss regulations under the stark law provide for certain relationships that are excepted from the stark law's prohibitions. 56 again, similar to the anti-kickback statute, the stark statute generally will not affect p4p arrangements between providers and payers since the providers do not refer "designated health services" to payers. such services most often are referred to hospitals or other ancillary providers, such as imaging centers or home health agencies. as such, the stark statute often will be implicated in hospital/physician alignment strategies due to the referral relationship between the parties coupled with the financial relationship created by most alignment arrangements. importantly, a prerequisite to any such alignment strategy is the existence of an exception under the stark statute that will ensure compliance with this civil statute. 53. 42 c.p.r.§ 411.370(b) (2006). 54. 42 u.s.c. § 1395nn (2006). 55. 42 u.s.c. §§ 1395nn(g)(3), (4) (2006). 56. 42 c.f.r. § 411.354 (2006), et seq. 2006] augnjng hospital and physician incentives 345 d. internal revenue considerations to qualify for exemption under internal revenue code section 501(c)(3), an organization must be organized and operated exclusively for religious, charitable, scientific or educational purposes. 57 the "promotion of health" has long been recognized as a charitable purpose so long as it is for the benefit of the community as a whole. 58 to satisfy the organizational test, the organization's governing documents must: (i) limit the organization's purposes to one or more exempt purposes; (ii) not expressly empower the organization to engage in nonexempt activities; (iii) provide that, upon dissolution, assets will be distributed for one or more exempt purposes; and (iv) not empower the organization to devote more than an "insubstantial" amount of activities to engage in activities which, in themselves, are not in furtherance of the organization's exempt purposes (including, for example, influencing legislation or participating in political campaigns). s9 to satisfy the operational test, the organization must be operated exclusively for one or more exempt purposes, i.e., it must engage primarily in activities that further its tax-exemptpurpose orpurposes.60 for federal income tax purposes, the irs has ruled that the activities of a partnership should be considered the activities of the partner.61 the irs has taken the position that this approach also applies for purposes of the operational test of exemption. 62 thus, the activities of a joint venture that is structured as either a partnership or as an llc that is treated as a partnership for federal income tax purposes also will be considered to be the activities of the joint venture's tax-exempt participants. code section 50l(cx3) also requires that no part of the exempt organization's net earnings inure to the benefit of any private shareholder or individual. 63 there is no de minimis exception to the proscription against private inurement. if any private inurement is found, exemption will be revoked.64 the term ''private shareholder or individual" refers to persons 57. i.r.c. § 501(c)(3) (2006). 58. see rev. rul. 69-545, 1969 c.b. ll7. 59. treas. reg.§ 1.501(c)(3)-l(b) (1959). 60. treas. reg.§ 1.50l(c)(3)-l(c)(l), § l.501(c)(3)-l(d)(ii) (1959). 61. see butlerv. comm'r, 36 t.c. 1097 (1960); rev. rul. 98-15, 1998-1 c.b. 718. 62. id. 63. treas. reg.§ 1.501(c)(3)-1(c)(2)(1959). 64. see, e.g., mcgahen v. comm'r, 76 t.c. 468,482 (1981); spokane motorcycle club v. united states, 222 f. supp. 151 (e.d. wash. 1963). 346 indiana heal til law review [vol. 3:325 having a personal and private interest in the activities of the organization.65 irs rulings and case law apply the private inurement proscription only to "insiders," defined to include a person receiving a benefit as a result of his, her, or its control or influence over the taxooexempt entity, such as shareholders, founders, directors, officers, or major contributors.66 whether a physician is an insider depends on an analysis of all the facts and circumstances concerning whether the physician's relationship with the organization offers the physician the opportunity to make use of the organization's income or assets for personal gain.67 in 1996, congress enacted the "taxpayer bill of rights 2" which, among other things, imposed a series of penalty excise taxes in "excess benefit transactions" where exempt organizations: (i)payunreasonablecompensation to individuals that are in a position to substantially influence the organization; (ii) pay compensation based in whole or in part on the revenues of the organization in a manner that results in private inurement; or (iii) enter into arrangements that result in the payment of more for assets than such assets are worth or selling assets for less than they are worth. these provisions, which are commonly referred to as the "intermediate sanctions law," are effective for transactions occurring on or after september 14, 1995.68 in january 2002, the irs issued final regulations closely following the temporary regulations. these final regulations have significant implications for taxooexempt organizations, and in particular, health care providers, as they provide amplification and clarification of the provisions of code section 4958.69 tax-exempt hospitals that engage in physician alignment strategies will need to ensure that such strategies are consistent with their charitable purpose and that no more than fair market value is paid to physicians as part of any incentive program. with proper structuring, these objectives can be accom­ plished. v. conclusion pay-for-performance programs are aimed at revising a reimbursement system based on the number and complexity of services provided, to one based on objective measures of quality and efficiency. the debate will rage on, and time will tell, as to whether a p4p system will gain true traction in the health services marketplace and, more importantly, whether it will yield measurable improvements in quality of care. those hospitals and health systems that use this time to align incentives with their physicians around 65. treas. reg.§ 1.50l(a)-l(c)(l959). 66. treas. reg.§ t.501(cx3)-l(d)(lxii)(l959). 67. see generally lawrence m. brauer & charles f. kaiser lll, physician incentive compensation, i.r.s. cpe materials for fy 2000 (july 1999). 68. i.r.c. § 4958 (2006). 69. id 2006] augnjng hospital and physician incentives 347 quality, patient safety, efficiency, and deployment of technology will gain a strategic advantage in the marketplace and may even achieve significant progress toward a more rational system of health care delivery. c. paul wazzan c. paul w azzan is a principal with lecg, inc. he specializes in providing financial and economic analysis in the areas of securities, options and futures, antitrust, damage analysis, health and labor economics and intellectual property. he holds a b.a. in economics from the university of california, berkeley and a ph.d. in finance from the university of california, los angeles. dr. wazzan has taught valuation methods at the university of southern california, marshall school of business. some of the areas in which dr. wazzan has conducted substantial analysis include the competitive effects of mergers, joint ventures, monopolization, price discrimination, market definition, securities fraud, and patent infringement. his analyses have covered a wide range of industries, including basic manufacturing (e.g., mining, oil and gas, steel, food processing and distribution); high-tech manufacturing (e.g., aircraft and avionics, semiconductors, personal computers, computer peripherals); and services (e.g., banking, metals trading, organized financial markets). in addition, dr. wazzan has extensive experience in applying economic and financial analysis to the pricing and use of options and futures on the international commodities markets (e.g., comex and the london metal exchange). some of the engagements that dr. w azzan has been involved with in this area are: 1) analysis of the impact of attempted manipulation of commodities options and futures; 2) analysis of the transmission of price information between the comex and the lme; and 3) analysis of the structural differences between the comex and the lme and the impacts of these differences on prices. dr. wazzan has published on the impact of socially motivated shareholder activism and the influence of pension fund investment/divestment on securities prices and is a member of the american finance association and the american economic association. dr. w azzan can be contacted at pwazzan@lecg.com or 310-556-0622. kau p. chowdhury mr. chowdhury serves as a research analyst for lecg. his primary focus is to provide litigation support through economic consulting. this support entails using statistical analysis of data and interpreting the information as they apply to antitrust, finance, intellectual property, and other economic i socioeconomic fields. he has been published in academic journals in both the united states and bangladesh. mr. chowdhury received his b.a. in business economics at the university of california, riverside. he is also a member of the golden key international honor society and the phi theta kappa international honor society. mr. chowdhury can be contacted at kchowdhury@lecg.com or 310-556-0766. wuham r. sellman dr. sellman is a full time practicing physician providing broad-based spectrum care in a group practice setting in northern california (alameda). his area of expertise is family practice, including on-call responsibility, clinical and hospital medicine, practice management, process improvements, and staff education. dr. sellman also serves as on-site clinical proctor for ucsf school of medicine students. additionally, dr. sellman is involved in the implementation of information technology at the hospital and clinical levels. dr. sellman received his medical degree from case western university school of medicine in 1996. he completed his family medicine internship at the university hospitals of cleveland in 1997, and completed his residency training in family medicine in california at the ventura county medical center, where he served as chiefresident from 1998 to 1999. following his residency , he became an attending physician at the ventura county medical center and the magnolia family health care and women's center in oxnard. from 2000 to 2002, dr. sellman served as a medical officer special status at the bay islands hospital located in northland, new zealand. he was one of three doctors providing primary, emergent, and in-hospital care in a rural setting. additionally, he provided emergency care education for the nursing staff. his awards and honors include the alfred s. maschke award for excellence in the art and practice of medicine, the figgie/rawlings memorial scholarship, and the a.j. sherman scholarship for indigent medical care training. dr. sellman is licensed to practice medicine in california. dr. sellman can be contacted at william@sellman.net or 510-521-2300. michael alan zimmerman dr. michael alan zimmerman is a full-time physician in alameda, california. he practices full spectrum family medicine including pediatric, adolescent, adult and elderly care. in addition to his medical practice, dr. zimmerman serves as the director of performance improvement at affinity medical group ip a. he also serves as a member of the breakthroughs in chronic care program's population management task force sponsored by the pacific business group on health. dr. zimmerman is also the lead physician for the california academy of family practice's new directions in diabetes care in alameda. he is an active member of the alameda hospital executive, medical and clinical information systems committees. dr. zimmerman received his medical degree from case western reserve university ("cwru'') school of medicine in 1998 where he was part of the robert wood johnson general initiative primary care track. while in medical school, dr. zimmerman served as the presidents of both the american medical student association cwru chapter and the humanistic medicine taskforce. in 2001, dr. zimmerman completed hisfamilypractice residency at ventura county health care system in california. his awards and honors include the award of distinction by the department of family medicine and the alfred a. masheke award for excellence in the art and practice of medicine from the cwru school of medicine. dr. zimmerman is a member of the american academy offamily physicians and the california academy of family physicians. he is licensed to practice medicine in california. dr. zimmerman can be contacted at mzimmerman@netopus.com or 510-5212300. an economic analysis of the imp act of pay -for­ performance lnitiatnes on physicians, patients and insurance providers c. paul wazzan, ph.d. kali prasun chowdhury william r. sellman, m.d. michael a. zimmerman, m.d." i. introduction america's health system is a monster. it is by far the world's most expensive: the united states spent $1.9 trillion on health in 2004, or 16% ofgdp, almost twice as much as the oecd average. 1 there is little doubt that the costs of providing health care services in the united states have increased dramatically in the last decade (from twelve percent to sixteen percent of gop) and continue to increase at a rapid rate.2 these costs are partly driven by the increasing life expectancy, increasing chronicity of diseases, multiplication of new medical standards and protocols, proliferation of new and costly technology and medicines, and a more knowledgeable patient population demanding the newest and most expensive treatments. the increased costs are also driven by the tripartite nature of the medical care system. this tripartite system is accurately described as an indemnity insurance system (in which patients do not directly pay for services, and doctors are not paid by patients) that leads to what is commonly known in economics as a "principavagent" problem. the unequal information available to each participant in this tripartite system also leads to what is commonly known in economics as an "informational asymmetry" problem (demonstrated in figure l ). * c. paul wazzan, ph.d., is a principal with lecg, corp. and specializes in providing financial and economic analysis; b.a university of california, berkeley; ph.d. university of california, los angeles. kali prasun chowdhury is a research analyst with lecg, corp.; b.a. university of california, riverside. william sellman, m.d. is a practicing physician with the affinity medical group ip a in northern california; m.d. case western university school of medicine. michael zimmennan. m.d., is a practicing physician with the affinity medical group ipa in northern california; m.d. case western university school ofmedicine. i. desperate measurers-america's health-care crisis, economist, jan. 28, 2006, available at http://www .economist.comlworld/displaystory.cfm?story _id=5436968 (last visited mar. 25, 2006) (article title in printed version of the economist is can george bush fix american health care?). 2. see marc kaufman & rob stein, record share of economy is spent on health care, wash. post, jan. l 0, 2006, at ao l. 358 indiana health law review [vol. 3:349 figure 1: the principal-agent and informational asymmetry problems in the current medical system imul'llllce provider .. ~ .... --:::-_in_su_ra_n_ce _ __,l• 1 makes paymentll to i -~/ patient pays idsul'llllce premiums to imurance patient physician 1 4•--------t~iji-•1 i ~----a--~ •------------------· --prlneipai/agent: pbysidan provides services to patient, bat is paid by idsurajic'e provider, while patient makes premium payment!~ to idsul'llllce provider bat reo9ves servic:es from physiclan. -· informational asymmetry: imurance provider is unable to measure the cost eft'icleacy of eare pro"rided. by tbe physielan. patient and insurer are unable to measure the quality of eare provided by tbe physician. a. the principal/agent nature of the medical system leads to conflicts of interest and reductions in economic efficiencies in the provision of health care services public (e.g., medicare and medicaid) and private (e.g., blue cross) health insurance providers are faced with what is known in economics as an "agency problem" or "principal-agent problem." interests are regularly at odds. the best interests of the patient (e.g., the best health care for the individual regardless of cost, since insurance pays for it, and regardless of whether that means reduced service for other participants in the system) are not routinely aligned with the interests of insurance providers (to provide the satisfactory level of care, for a fixed amount of dollars, to the aggregate members of the insurance plan). these interests in turn can be misaligned with the interests of the medical service provider (to provide the best level of care within financial limits, while receiving an acceptable personal wage). in the present system, participants work to maximize their own utility at the cost of the system, disregarding the fact that it is in the best interest of all concerned to work collectively for the common good to reduce occurrence of disease, improve the underlying health of the patient, and simultaneously, to reduce cost. the medical service provider, occupying the middle ground, is placed in the position of having to provide health care services to the patient, while 2006] an economic analysis of p4p inmatives 359 looking to the insurance provider for payment as will be discussed more fully below, because the existing system relies on pay for services rendered rather than pay for efficiency and performance, the physician often has little monetary incentive to provide superior or efficient services. 3 b. the informational asymmetries inherent in the medical system cause reductions in economic efficiencies in the provision of health care services the tripartite nature of the medical system directly leads to an informational asymmetry problem because all information is not equally well known by all parties in the system. for example, it is often difficult for patients and insurers to determine whether the services provided by the physician have been above or below average (e.g., the persistence of a disease could be due to the nature of the disease, the actions of the patient, the inefficiency of the doctor, or some other plausible reason). it is therefore endogenous to indemnity insurance systems that the well-being of the beneficiaries and the insurer are overlooked because there are no real base measures against which to compare success. c. the ideal physician compensation scheme is one that reduces the principal-agent and informational asymmetry problems these unique characteristics of the medical services market-described by nobel laureate kenneth arrow as uncertainty in disease incidence, treatment efficacy, and asymmetric information between doctor and patient-in conjunction with the demographic changes occurring within the united states point to the need for innovative and economically sound solutions to ensure that the u.s. health care system continues to benefit from a high level of service.4 to that end, pay-for-performance ("p4p'') initiatives, which attempt to align the incentives of health care providers, insurance carriers, and patients, and to reduce the informational asymmetry and principal-agent problems, have been proposed. this article describes the current medical system, provides a brief description of the various p4p initiatives, and attempts to provide insight into the potential effect on the participants in the medical system (i.e., patients, physicians, and insurance providers). 3. in some instances, it is even possibletbatunnecessar}>tests may be encouraged simply because neither the patient nor the physician is bearing the costs of prescribed treatments. 4. see kenneth j. arrow, uncertainty and the welfare economics of medical care, 53 am. econ. rev. 941 (1963). 360 indiana healtii law review (vol. 3:349 ii. a brief description of the current system and the various pay­ for-performance initiatives proponents of p4p systems essentially believe that if physicians (or hospitals) are competing-on a relative basis to their peers-for increased monetary rewards, this form of induced competition will force them to take actions not merely for the sake of the patient, but also for their own financial good. the critical question is whether the proposed p4p incentives are sufficient to align the varying interests in a manner that allows free market conditions to generate pareto efficienci while resolving (or reducing) the principal-agent and informational asymmetry problems. a. the current system for physician and hospital reimbursement the p4p initiatives are markedly different than the current system for determining reimbursement levels for physicians and hospitals; the latter is based on what is called the resource based relative value scale ("rbrvs"). 6 the rbrvs system involves a somewhat complicated set of calculations that reimburses physicians and hospitals based on objective values calculated from thousands of procedures. the system is broken down into three parts: physician work component (fifty-two percent), practice expense component (forty-four percent), and professional liability insurance (four percentv in essence, every type of medical service (e.g., fixing a broken arm) is divided into the resources necessary to provide that service (e.g., physician time, x­ rays, plaster, nursing services, etc.), and these resources are given a weighted value that depends on the time, energy, and effort required to perform that function along with the medical equipment, malpractice insurance, and administrative costs. thus, a relative value unit for physician services is comprised of three factors: actual work performed, practice expense, and physician liability insurance-each of which has its own weighted value based on the nature of the service provided. the system also takes into account cost of living differences for various geographic locations. the rbrvs does not specifically provide physicians or hospitals with any incentives to improve service or efficiency. in fact, because compensation has to be budget neutral (i.e., total pay out to physicians/hospitals must remain steady), there may actually be less incentive to improve efficiency as 5. ronald g. ehrenberg & roberts. smith, modern labor economics theory and public policy 7 (8th ed. 2003) (defining pareto efficiency as ''a condition when no more transactions take place in a market because it is not mutually beneficial"). 6. gregory j. przybylski, understanding and applying a resource-based relative value system to your neurosurgical practice, 12 neurosurgical focus, at 1 (2002), available at http://www.aans.org/education!journallneurosurgicallapr02/l2-4-3.pdf (last visited mar. 25, 2006). 7. am. med. ass'n., medicare rbvrs: the physician's guide 2005 24 (patrick e. gallagher et al. eds., 2005). 2006] an economic analysis of p4p inmatives 361 improvement by itself may not guarantee higher payments. 8 furthermore, remuneration is simply based on a set of criteria that are essentially unaffected by the performance of the medical provider; the provider is paid a fixed amount regardless of the outcome. in addition, there· is often a time lag between improvements in medical procedures (i.e., a new procedure is found to improve patient outcomes) and an adjustment to the medical provider compensation calculations. in other words, a new procedure that may be costly, might remain uncompensated for a lengthy period of time before the variables and calculations are adjusted.9 a medical provider adopting this new costly procedure could actually end up worse off financially. consequently, physicians and hospitals can have reduced incentives for finding superior or efficient techniques. b. public pay-for-performance initiatives as of2006, there are several public p4p initiatives being actively tested in limited geographic areas as a result of the medicare, medicaid, and state children's health insurance program ("schip"), benefits improvement and protection act of 2000 ("bip a"), and the medicare modernization act of 2003 ("mma'').10 these acts collectively provide for the following initiatives: 11 • hospital quality initiative • premier hospital quality incentive demonstration • physician group prictice demonstration • medicare care management performance demonstration • medicare health care quality demonstration • chronic care improvement program • esrd disease management demonstration • disease management demonstration for severely chronically ill medicare beneficiaries 8. medical providers do bave reputational incentives which can eventually translate to financial compensation. for example, a physician practice group that develops a reputation for excellence might be able to attract higher paying non-insurance patients. 9. it is our understanding that cms's update schedule for the rbrvs system is not very responsive to changes in the patient care field. for example, adjustment to the physician liability insurance relative value unit ("plirvu'') occurs every five years. see am. med. ass'n, medicare resource based physician liability insurance, http://www.ama­ assn.orgfamalupload/mm/363/pliwhitepaper.pdf (last visited mar. 25, 2006). l 0. a complete listing of what these acts entail can be found at the cms website. ll. press release, u.s. dep't ofhealth & hum. servs., ctrs. for medicare & medicaid servs., medicare "pay for performance (p4p)" initiatives (jan. 31, 2005), available at http://new.cms.hhs.gov/apps/medialpresslrelease.asp?counter=l343 (last visited mar. 25, 2006). 362 indiana heal til law review [vol. 3:349 • disease management demonstration for chronically ill dual eligible beneficiaries • care management for high cost beneficiaries these initiatives generally detail a set of criteria by which medical service providers (e.g., physicians and/or hospitals) are graded, with compensation being determined by the awarded grade. to illustrate, the premier hospital quality incentive ("phqp') is primarily based on criteria developed by the centers formedicare and medicaid services ("cms"). for example, acute myocardial infarction (i.e., heart attack) services are graded in nine categories: aspirin provided at anival hospital; aspirin prescribed at discharge; prescribed angiotensin converting enzyme inhibitor ("acer') for left ventricular systolic dysfunction ("l vsd''); provided anti-smoking advice or counseling; beta blocker prescribed at anival; beta blocker provided at discharge; thrombolytic therapy received by patient within 30 minutes of hospital arrival; percutaneous coronary intervention ("pcp') received by patient within 120 minutes of hospital anival; and inpatient mortality rate. a hospital scoring in the top ten percent for these measures would receive a two percent bonus payment on top of the standard diagnosis-related groups ("drg") payment for the relevant discharges.12 those scoring in the next ten percent would receive a one percent bonus. eventually, hospitals failing to meet a certain minimum score are subject to reductions in payment 13 note that some of the criteria of the phqi are process driven (e.g., whether aspirin was administered as per a protocol) whereas others are results driven (e.g., inpatient mortality rate, in which the actual outcome of the procedure is measured). presumably the process driven measures ate believed to be generally beneficial to the average patient. the results-driven criteria are more clearly reliant on the "skill" of the hospitals or physicians involved. it is also important to note that none of the grading criteria are subjective. the rules are either followed or not followed. likewise, the patient either recovers or does not recover. the process criteria are presumably set to maximize the expected welfare of the patient while simultaneously reducing the costs of providing care. to the extent that the criteria are flawed, the end results are also flawed. if one assumes that the criteria are defined correctly, then favorable results should be obtained, assuming that the monetary incentives suffice to ensure compliance with the specified criteria (this is largely an empirical matter). ideally, these performance measures are designed around established standards of care that provide evidence-based outcomes. 12. note that the drg is the current system. 13. see fred 0; baldwin. where medicare goes ... ·the rest of the system may well follow cms' pay-for-performance example, iiealtiicare informatics, apr. 2004, at 24, available at http://www.healthcare-informatics.com/issuesl2004/04 _ 04/cover.htm(lastvisited mar. 25, 2006). 2006] an economic analysis of p4p initiatives 363 c. private pay-for-performance initiatives many private health plans have possessed their own p4p programs since the 1990s. 14 these programs have typically not been standardized, have contained inconsistencies in measurement or grading (and thereby provided disparate incentives), and have not provided uniform objectives with respect to information technology ("it") investment. in an effort to consolidate such varying standards and to better align the interests of the participants (e.g., reduce the informational asymmetry and principal agent problems), third-party associations such as the integrated healthcare association ("iha") in california have recently emerged to coordinate the initiatives. the iha initiative involves over 225 medical groups/independent practice associa­ tions, seven major health plans, and over 6.2 million hmo enrollees.15 the participation of prominent and nationally known health plans highlights the level of private and corporate interest in p4p and the potential impact these initiatives will have on the health industry. 1. standardization of the p4p plans the importance of the standardization proposed by the p4p initiatives cannot be understated. total incentive payments to physician groups equaled $37.4 million for the iha metrics in the 2003 measurement year. for this first year, payouts for the clinical and patient experience domains were relatively equal at about $17 million each, with the balance of about $3 million paid for information technology.16 payouts varied considerably by health plan. this variation reflects both the differences in enrollment and maximum payment thresholds of participating health plans. total payments in 2005 for the second measurement year, 2004, are estimated to be about $54 million, reflecting substantial payment increases by several plans and the addition of a plan. 17 while this data suggests that the plans participate significantly in the iha initiatives, they do so inconsistently with respect to their total payment allocations. consequently, the incentives provided by these plans are not uniform and hence, the results obtained are not uniform. 14. "although cms often sets a standard for private health insurers in areas like payment systems and coverage policies, mcos are far ahead of medicare when it comes to pay-for­ performance (p4p) programs." private payers proceed on p4p programs, while watching cms's programs and demos, managed care week, may 2, 2005, at 1, available at http://www.aishealth.com/managedcare/genbus/mcw _p4p _payers.html (mar. 25, 2006). 15. iha acts in collaboration with the pacific business group on health ("pbgh"), which represents over six million californians enrolled in private health plans. integrated healthcare ass'n, advancing quality through collaboration: the california pay for performance program, at 2 (2006), available athttp://www.iha.org/wp020606.pdf(last visited mar. 25; 2006). 16. /d. 17. /d. 364 indiana health law review [vol. 3:349 2. uniform performance measurement we have already described how uniform measurement is essential to the p4p initiatives. within the ira's p4p framework, the performance measures used for evaluating physician groups as of 2005 are allocated as follows: clinical-fifty percent (percent of a physician group's score); patient experience-thirty percent; it investment-twenty percent; and individual physician feedback program-ten percent override (table 1 ). table 1: domain weightings for iha p4p lnitiative18 l. childhood immunization status 2. appropriate treatment for children with upper respiratory infection 3. breast cancer screening clinical 4. cervical cancer screening recommended weighting: 50% 5. chlamydia screening in women 6. use of appropriate medication for people with asthma 7. diabetes care: hbalc screening 8. diabetes care: hbalc poor control 9. cholesterol management ldl screening 10. cholesterol management: ldl control <130 1. specialty care patient experience 2. timely access to care recommended weighting: 30% 3. doctor-patient communication 4. care coordination (pas composite) 5. overall ratings of care 1. integrate clinical electronic data sets at group level it investment for population management recommended weighting: 200/o 2. support clinical decision making at point of care through electronic tools the weightings of these allocations relate significantly to levels of objectivity. the clinical entities, for example, are commonly accepted standards of care with important clinical ramifications. moreover, they are readily measurable. patient experience and information technology, conversely, are less 18. integrated healthcare ass'n. p4p 2005 measurement year i 2006 reporting and payment year, http://www.iha.org/p4py3.htm (last visited mar. 25, 2006). 2006] an economic analysis of p4p initiatives 365 standardized entities and are more challenging to measure and implement on a large scale. 3. consistent incentives and objectives with respect to information technology it is useful here to further comment on the properties of the information technology investment. as this component is often mistaken for a panacea for the health care system's ills. within the p4p initiatives, there exist information technology components that seek to encourage physicians and hospitals to upgrade and modernize their information technology processes by standardiz­ ing and automating record keeping, improving communications between providers, and generally increasing data management techniques. 19 it is clear that medicine suffers from uncoordinated data services; indeed, one of the greatest difficulties for healthcare providers and insurers in a p4p program is to adequately quantify their performance. these difficulties stem from high overhead costs and flawed processes downstream in the healthcare system where provision of care actually occurs. because of these significant limitations, the it component of p4p initiatives at this stage aims to coordinate and support data systems. major it efforts include clinical messaging, creating condition-specific registries, forming p4p "action lists", streamlining billing, and establishing in-house technical support.20 importantly, such suggested it systems are not merely electronic reiterations of the ubiquitous paper systems. they aim instead to be dynamic portals that not only enhance data transfer and accountability, but also provide a clearer window into traditionally un-measurable information. only this type of system and capability will generate the support of providers, insurers, and healthcare purchasers who want to track meaningful population data. ill. the potential impact of p4p initiatives on physicians as we have shown, the initiatives generally seek to enforce physician and hospital compliance with procedures that are believed to be beneficial to patients while simultaneously being cost effective. there is currently no conclusive evidence as to whether these plans will perform as hoped therein lies the debate. on a theoretical level, it is our belief that a p4p system reduces at least some of the informational asymmetry and agency problems of the rbrvs system. for the purposes of the following theoretical analysis, we assume that the initiatives work as expected. 19. am. med. ass'n, physician pay for performance (p4p) initiatives, http://www.wsma.orglresourceslp4p.revised_ wc2.pdf(last visited mar. 25, 2006). 20. /d. 366 indiana health law review [vol. 3:349 a. p4p initiatives will likely increase overall physician peiformance levels while compensating superior peiformers as discussed earlier, compliance with the p4p protocols is ensured by rewarding complying physicians with additional payments.21 to the extent that physicians exhibit logarithmic utility functions (in essence always preferring more compensation to less), we would expect the initiatives to increase compliance. the critical question is not whether financial incentives can elicit the desired behavior, but rather whether the specified criteria are indeed maximizing patient welfare while concomitantly minimizing cost. this is an empirical matter, but simplistically, if all physicians are forced to adhere to the procedural criteria, the result criteria will dominate. this will allow superior physicians and facilities to earn additional money at the expense of those who perform less ably. it should be noted that certain physician groups have expressed concerns that physicians will focus only on measured criteria at the expense of other important medical decision making; this in turn may argue for broader clinical penetration ofp4p. a welcome result for physicians will be the substantial transfer from utilization review (a process for monitoring the use and delivecy of services that is often used by managed care providers to control health care costs) to quality review (performance as a function of quality, as in outcomes or appropriateness/effectiveness of care). utilization review has long been known to be necessary but has been viewed as a relatively passive and disconnected metric for evaluating and reimbursing patient care. utilization metrics can merely dissuade appropriate patient care; p4p more closely aligns physician action (versus inaction) with quality processes and outcomes .. in other words, utilization review focuses on strictly curbing the cost of services provided thereby often placing financial decisions above quality healthcare decisions. the p4p approach aims to make quality the driver for medical decision making, with the long-term goal of decreasing costs as a result of more appropriate medical decision making. importantly, p4p still faces challenges within the physician community. some primary care physicians are skeptical of medicare's p4p initiative because they believe medicare has fmancially undervalued the role of primary care services. the american academy of family practice, for example, opposes cms 's recently unveiled the physician voluntary reporting program (in which physicians themselves directly report performance data to medicare 21. baldwin, supra note 13, at 23. 2006] an economic analysis of p4p initiatives 367 and receive feedback on their performance) because it feels physicians will shoulder a disproportionate burden of the program. 22 the most significant divide, however, will exist between those physicians and provider groups that possess functional infrastructures and those that do not. the collection of data demanded by p4p requires it and communication protocols to function as accessible data portals; currently, it is not uncommon for such systems to be merely extensions of inadequate and cumbersome paper systems. whether p4p's it initiative alone can help meet this challenge in step with its other initiatives is uncertain. iv. the potential impact of p4p initiatives on insurance carriers the financial effects of p4p initiatives on insurance carriers (whether government funded medicare system or private health insurance company systems) could be significant again, the financial incentives inherent in the p4p systems are likely to cause physicians and hospitals to adhere to the stated criteria, while simultaneously developing improved techniques or procedures, and improving patient outcomes. as previously stated, the relevant question is whether adherence to the stated criteria for each initiative reduces costs, while improving patient outcomes. it is unknown whether the introduction of new procedures (motivated by the p4p initiatives) will increase or decrease the cost of medical care. for example, development of new efficiencies may reduce costs, whereas development of new techniques could require costly new medicines. additionally, an argument could be made that p4p may result in additional expense for insurers ifbetter screening (because ofp4p) diagnoses more patients with treatable diseases, as these patients or conditions will, of course, require treatment. consequently, it is not clear whether the financial impact on insurance carriers will be positive or neutral. unfortunately, it is impossible to tell on a theoretical basis what will be the direction (i.e., more or less expensive) or the magnitude of the change. one potential indication as to the expected direction of the change is that the insurance companies themselves are positioning sound p4p initiatives as a marketing driver.23 it is important to remember that a key characteristic of providing medical care is inconsistent with most other provision of goods and services in a market economy: the majority ofhealthcare is provided locally.24 motivation for an information infrastructure on a state or national scale, therefore, has 22. medicare takes first steps toward pay-for-performance, 13 fam. prac. mgmt. 27' 27 (2006). 23. press release. integrated healthcare ass'n, top performing northern and southern califonia physician organizations identified by integrated healthcare association (oct. 10, 2005) available at http://www.iha.org/l00605.htm. (last visited mar. 25, 2006). 24. a.j. vogl, is anybody happy with our healthcare system?, 42 across 'nib board 34, 34-40 (2005). 368 indiana health law review [vol. 3:349 been lacking. the it component of the p4p initiatives bas hope for success largely because it ventures to meet the needs of all involved parties (providers, insurers, and purchasers). with support, physicians will be incentivized to redesign or upgrade their electronic management of patient data, billing, and scheduling systems. by definition, p4p necessitates accurate and transferable patient-related data among insurers, purchasers, and providers. success among the p4p clinical initiatives should further illuminate this important relationship. v. the potential impact of p4p initiatives on patients the effect of p4p initiatives on patients (or consumers of medical services) will be felt in two ways. first, for consumers of medical services and purchasers of medical insurance (either private or public), any resulting reductions in medical costs will likely result in reduced medical insurance premiums (private) or reduced government expenditures (public). note that medical insurance premiums are set to cover the expected cost of providing coverage. competition ensures that reductions in costs will generally be translated into reductions in premiums. second, to the extent that p4p encourages superior service and the development of new beneficial techniques, patient care and outcomes could be improved. economic theory suggests that patient outcomes will improve while efficiencies are obtained but, again, this is largely an empirical matter. vi. preliminary results of p4p initiatives and conclusion given the agency and informational asymmetry problems inherent in the existing medical system as described above, it is probably impossible to achieve perfectly competitive market conditions. nevertheless, economic principles and theory indicate that the current p4p initiatives are likely to produce improvements over the rbrvs system. the fmal determination as to whether the p4p system provides long-term reductions in costs and improvements in the level of medical service will require empirical verification. recent studies have shown encouraging results. preliminary analysis of first-year performance found median quality scores for hospitals had improved25: • from ninety percent to ninety-three percent for patients with acute myocardial infarction (heart attack); • from eighty-six percent to ninety percent for patients with coronary artery bypass graft; 25~ press release, cms office of public aftiirs. medicare pay-for-performance demonstration shows significantqualityofcare improvement at participating hospitals (may 3, 2005), available at http://www.cms.bhs.gov/appslmedialpresease?counter=441 (last visited mar. 25, 2006). 2006] an economic analysis of p4p initiatives 369 • from sixty-four percent to seventy-six percent for patients with heart failure; • from eighty-five percent to ninety-one percent for patients with hip and knee replacement; and • from seventy percent to eighty percent for patients with pneumonia. of particular relevance in the context of these metrics, provider accountability can in fact improve performance significantly by as much as six times in comparison to situations where no accountability is present. 26 the long-term implications of the quality changes listed above, in combination with the magnitude of accountability they may engender, are yet to be determined. ultimately, the strength and ramifications of this combination will be central to best evaluating p4p's impact on healthcare delivery. 26. judith h. hibbard, jean stockard & martin tusler, does publicizing hospital performance stimulate quality improvement efforts?, 22(2) healthaff. 84, 84-94 (2003); see also fran90is de brantes, the promise ofpay for peiformance: better value, ge corporate health care, available at http://www.ehcca.comlpresentationslptpsummit/debrantes.pdf (last visited mar. 25, 2006). acknowledgemrnnts integrated healthcare association ("llia") wishes to extend special thanks and acknowledgements to the california healthcare foundation for its steadfast support of the california pay for performance program. grant funding for early program development, technical support and ongoing program evaluation has been essential to the project. equally important, the early leadership of the foundation's ceo, mark smith, m.d. has contributed greatly to the success of the program. we also acknowledge the support of a cadre of organizational partners dedicated to quality improvement in healthcare including: california association of health plans, california association of physician groups, california department of managed healthcare, california medical association, california office of the patient advocate, diversified data design, glaxosmithk.line, the national committee for quality assurance, and the pacific business group on health. we congratulate the seven california health plans, aetna, blue shield, blue cross, cigna, health net, pacificare and western health advantage, who collectively established the foundation of the program. further congratulations are due to the 225 participating physician organizations and the 35,000 physicians whom they represent who have enthusiastically responded to the challenge of improving the quality of healthcare and patient experience for over six million californians. we also commend the kaiser permanente medical group for its recent entry into the public reporting component of the program. the active work and engagement of the members of the pay for performance steering and technical committees have provided governance and technical development through each stage of the program. without the time and commitment of committee members, the program would simply not exist the pay for performance planning committee which produced the five year plan was led by steve mcdermott, hill physicians, and included: ron bangasser, m.d., beaver medical group; david joyner, blue shield of california; lance lang, m.d., health net; arnie milstein, m.d., pacific business group on health; and pauline y an, glaxosmithk.line. editors: steve mcdermott and tom williams contributing editors: lauren lempert, j.d. and dolores yanagihara, m.p.h. design and layout: roza do advancing quality through collaboration: the california pay for performance program a report on the first five years and a strategic plan for the next five years introduction it has been five years since the conception of the california pay for performance (''p4p") program sponsored by the integrated healthcare association ("iha''). during this time, the program has matured to become the largest and most prominent pay for performance program in the country. the program helped launch national and international interest in the use of performance measurement and financial incentives to promote healthcare quality in all sectors of the healthcare industry. this iha sponsored program has achieved its initial goals: a uniform perfonnance measure set, significant incentive payments to physician groups, and a public report card. progress has also been made toward performance improvements in clinical quality, patient experience, and the use of infonnation technology to support population management and patient care. this report was prepared in conjunction with the development of a strategic plan for the next five years (2006-2010) of the california pay for performance program. program stakeholders face new challenges: evolution of performance measures, increased incentives, enhancing the business case for quality, and expansion of the program to new populations. these challenges are no less daunting than those faced at the program's onset, yet one key advantage exists today: an underlying spirit of collaboration, created by the commitnient of a core group of dedicated stakeholders and hundreds of organizations to an idea that is larger than the interests of any single participating individual or group. i. executive summary the iha-sponsored california pay for performance program is an ongoing testament to the power of collaboration. it also reflects california's unique confluence ofhealthcare delivery, reimbursement, and financing which contributed to both the opportunities and challenges presented by this initiative. responding to the consumer backlash against managed care in the 1990s, california health plans and physician groups added quality-based financial incentives and public report cards. however, these efforts were frustrated by inconsistent performance metrics, contradictory public reporting, insufficient sample sizes, and minimal funding. leading physician groups 456 indiana healrn law review [vol. 3:453 appealed to the health plans to develop a uniform set of quality performance measures and a single public report card. california's health plans responded favorably to this challenge, and despite seemingly insurmountable logistical problems, a successful pay for performance program emerged through the synergy of timing, leadership, and cooperation. the integrated healthcare association, a unique collaboration of key california stakeholders, and particular individuals within this organization took the lead. by emphasizing innovation through collaboration and setting core guiding principles, they successfully designed and implemented a pay for performance program with one overriding goal: to create a business case for quality improvement through a compelling set of incentives that would drive breakthrough improvements in the quality and experience of healthcare. key to the program's success is the use of uniform measures to evaluate performance across multiple health plans, physician groups, and patient populations. the initial performance measurement set has three domains: clinical, patient experience, and information technology. the weighting of these domains is dynamic, and measures within each domain ate evolving each year. incentive payments are an essential ingredient. however, it has been difficult to arrive at a uniform approach to incentive payment in the absence of standards for payment methodologies and due to anti-trust concerns. transparency is also a key element. program oversight is provided by the iha board,, with program management and governance provided by steering, planning, and technical committees, and a technical team including experts from the pacific business group on health, the national committee on quality assurance, and iha staff. additionally, a team of researchers from the rand corporation and u.c. berkeley are currently evaluating the program. looking ahead, the planning committee revised the program's original mission and priorities and developed a set of recommendations to guide development and implementation over the next five years. these recommendations include: 1. increase incentive payments proportional to improvements in performance outcomes; 2. aggressively develop and expand the performance measurement set; 3. strengthen pay for performance administration to support an increasingly sophisticated program; and, 4. further develop public reporting, research, and public relations. california's pay for performance program is the largest in the country, and a potential model for other regional programs, as well as for adoption by the center for medicare and medicaid services. 2006] advancing quality through collaboration 457 ii. a story of collaboration "collaboration is the new frontier of human creativity."1 a. a momentoftruth it was time to bring to a close a meeting in northern california during the fall of 2001, and the ceo of the california healthcare foundation ("chcf"), mark smith, m.d., was asking the question, "are you in or out?" chcf had agreed to fund the technical development of a statewide quality incentive program, but only if the major health plans in the state agreed to participate. senior executives from the plans were present at the meeting, and they each had to take a position. the dynamics of the meeting suddenly became more serious. each health plan had its own set of considerations. some had already developed quality-based incentives and were in a leadership position. to commit their organizations to collaboration with a uniform approach to quality measurement would mean forsaking their position, yielding a potential competitive advantage. still other plans had not yet developed a program. participation could bring them parity; however, agreeing to meet the recommended minimum financial incentive targets would be a challenge. to date, the potential participants had been able to negotiate parameters without fully committing to the program, but mark was not allowing them any more wiggle room. it was a yes or no question. the tension in the room was palpable as each plan executive gave an answer. as one by one they said "yes," the california pay for performance program was born. however, to tell the story only from this point forward would leave out half the tale. california • spay for performance program has been built through the collaboration of otherwise unlikely partners. how they arrived at the pivotal meeting which launched the program and the roles played by key actors are among the most relevant aspects of this story, important to anyone considering a similar collaborative effort. b. the stage is set during most of the 1980's and the entire decade of the 1990's california rode the wave of managed care with particular vigor, embracing hmos and delegating many aspects of medical management to its elaborate system of physician groups. when consumers and providers across the united states bristled against the perceived vagaries of utilization management, both california health plans and physician groups were forced to reexamine many 1. michael 0. leavitt. sec. of health and human servs., u.s. dep't of health and human servs., june 5, 2005, himss summit: achieving national healthcare transformation. 458 indiana healrn law review [vol. 3:453 of their traditional managed care practices. one practice under particular scrutiny was financial incentives based solely upon utilization management in the late 1990's, several california health plans began to shift to quality based incentives, in a move well received by physician groups and purchasers. these plans, and a key purchaser, also began to publish report cards comparing physician groups and announcing top perfonning groups with great fanfare. despite the best intentions of the health plans, these actions began to raise the ire of the physician community. each health plan had a different set of performance metrics, making it difficult for physician groups to focus sufficient attention on any one set of measures. a cause of even more consternation was the "dueling report cards." a physician group might be touted as the top performer in a category (e.g. asthma management) by one plan, but rated as an average or below average performer in the same category by another plan. on top of these problems, funding for incentives was minimal. early efforts to measure and report quality also faced the challenge of obtaining a sufficient sample size to lend credibility to both publicly reported results and financial incentive payments. no single health plan had more than twenty·five percent of the managed care membership. consequently, each plan's ability to measure and report across multiple measures and physician organizations was limited. california's unique organization of healthcare delivery and financing contributed to both the opportunities and the challenges faced. a prevalence of larger, multi-specialty groups and independent physician associations ("ip as") offered a more unified voice for physicians than typical in most communities. the delegation of financial responsibility (capitation) under the organized group model offered the ability to implement quality improvement initiatives. at the time, however, the physician community was just emerging from a period of underpayment driven by several years of health plan pricing wars and declining premiums. for all these reasons, the community of physician groups and their leading statewide organization, the california association ofphysician groups ("capg"), posed a challenge to the health plans: "please cooperate with us to develop a uniform set of quality performance measures and one public report card." the logistical challenges seemed insurmountable. just engaging the health plans in a conversation about uniform business practices raised anti­ trust concerns. furthermore, the powerful pacific business group on health ("pbgh"), a statewide association of employers, had pitched a similar idea a few years earlier but it had not been implemented. it was viewed as an idea ahead of its time. so why was the iha effort successful? the answer lies in a combination of timing and leadership, guided by a spirit of cooperation and a vision larger than the personal interests of any one stakeholder or set of stakeholders. 2006] advancing quality through collaboration 459 c. call to action between the late 1990's, when the concept of a california pay for performance program began to take shape, and the critical meeting in 2001, a tremendous amount of important work and activity took place. as physician group leaders sought to advance the idea of collaboration, an important question was raised: "what group of leaders or organization should take the lead?" each major stakeholder group had a substantial trade association representing its interests: the pacific business group on health for employers and other purchasers ofhealth benefits; the california association ofphysician groups for physician organizations; and the california association of health plans ("cahp") for health plans. each was a well-respected advocate for its constituency, which undermined their ability to maintain the neutrality, or the appearance of neutrality, required to navigate a complex set of political and technical challenges. the integrated healthcare association, a statewide leadership organiza­ tion, was created in 1996. committed to the development of innovative public policy, healthcare industry dialogue, and related projects, its member organizations include balanced representation from all the major healthcare stakeholder groups in california. by virtue of its member organizations, iha is able to convene leaders from all sectors ofhealthcare statewide to fulfill its mission of"innovation through collaboration." iha was a unique organization ideally suited to sponsor pay for performance. the leaders of prominent california physician groups approached iha with the notion of developing a uniform program of quality incentives for physicians. iha accepted a leadership role in this process. a small band of dedicated leaders expended considerable time and political capital on behalf of this effort. the board chair ofiha in 2000 was steve mcdermott, the ceo of a large, successful california ip a. he was captivated by the notion of improving healthcare quality through a pay for performance program. in partnership with the iha executive director at the time, he organized a process of consensus building, assuring adequate dialogue and input from all key stakeholders. he then pushed the process forward, ensuring that sufficient support existed among key decision makers, and that member organizations committed publicly and collectively to the program. other iha board members also played important roles. tom davies, an iha board member representing verizon, played an active and key part. he reminded the health plans and physician organizations that the non-healthcare sectors of business had embraced quality improvement and felt they were not receiving value for their healthcare premium dollars. pauline y an, another board member representing glaxosmithk.line, was a steadfast supporter of a uniform performance measurement set, and helped to push the initiative forward by funding the action plan and pressing the 460 indiana health law review lvol. 3:453 actors to "do something,'' not just talk. arnie milstein, m.d., another board member representing large employers and members ofpbgh, advocated that incentives drive affordability of care, as well as quality. he laid out a vision of"breakthrough," rather than incremental improvement. a number ofhealth plan leaders also played critical roles, including cora tellez, head of health net of california at the time, who helped build essential support among the plans. the efforts of many other individuals, too numerous to enumerate, contributed to the initial organizational success of the california pay for performance program. those mentioned represent both important contribu­ tions and the diversity of stakeholder involvement. d. overcoming roadblocks and suspicion the potential for failure was a constant reality. physician leaders welcomed the prospect of additional incentives, but were adamant that they not undermine existing reimbursement levels. they demanded that incentives be funded with "new money." purchasers, however, were not prepared to pay additional premiums specifically for incentives, arguing that they were already overpaying for healthcare, and that quality improvement should lower costs. health plans were wary of any initiative that might undermine their ability to innovate. to collaborate means putting the group ahead of the individual for the collective good. it requires that everyone give something up in the hope of realizing an uncertain gain. each major stakeholder group experienced its own "moment of truth" before setting aside self-interest to move forward. ironically, the physician community almost undermined the program before it was launched. despite the initial call to action by physician group leaders, suspicion began to develop in the physician community following agreement by the health plans to proceed. less informed about the impetus and details of the initiative, some physician leaders were apprehensive about the project. a raucous meeting of the state's largest association for physician groups almost resulted in defeat of the proposed program. only a passionate plea led by key leaders pushed the vote to proceed. today this same association is a steady and strong program supporter. purchasers were less organized in their participation, but generally supportive until the discussion turned to the question of increased premiums to fund incentive payments. a resounding "no" was the common response, deflating enthusiasm for program organizers. eventually, employer leaders endorsed the program, encouraging organizers to proceed. ultimately, health plans committed to budget incentive payments without reductions in existing reimbursement levels. to date they have honored this commitment, and pay for performance incentives have been funded by health plans through a combination of premium rate increases, 2006] advancing quality through collaboration 461 administrative efficiencies, offset to capitation increases, and re-allocation of incentive payments from other programs. · moving key decision makers forward required incremental agreement on the nature of the program and basic organizing principles. this early step was helpful in clarifying the purpose and boundaries of the program, thereby allowing organizations to clearly understand their potential role and commitment. the overall program goal of the initial pay for performance plan was straightforward: to create a business case for quality improvement through a compelling set of incentives that will drive breakthrough improvements in the quality of healthcare and patients ' experience. the effort to achieve this goal was guided by several organizing principles: • participation is voluntary. • physician organizations will be accountable through a publicly reported scorecard based on common clinical and patient satisfaction measures. • participating health plans will offer significant financial incentives to physician groups based on their scorecard performance. • pay for performance is accomplished through a collaborative model involving purchasers, health plans, physician organizations, and consumers. e. creating guiding principles once the decision had been made to proceed with the program, a series of tough questions immediately emerged. what exactly would be measured? how would data be collected? how would the program be administered? how much would be paid in incentives? could quality really be measured and improved? to prevent backpedaling and loss of support, it was essential that the program goal and operating principles be expanded to provide guidance to the individuals charged with building the components of the program. a significant effort was made at this point to expand the initial organizing principles into a more fully developed set of guiding principles. this exercise began the process of collaboration, with stakeholders beginning to move beyond the notion of coordination and cooperation to building something together in a collaborative manner. the importance of the guiding principles cannot be overstated. they have been instrumental tools for decision making and stakeholder engagement. for example, the measure selection criterion calls for the use of administrative (electronic) data only for measurement. this principle allows the program to continue at its current large scale without extensive manual data collection 462 indiana realm law rbvmw [vol. 3:453 . . . . ·. . . . effort and cost. however, it.iritposes. a trade-off: the .~t availability of measures which move· i>eyond process to outcomes is limited; therefore~ evolution of the measure set has been slower than some would like. the existence ·of this guiding principle has proven extremely helpful as the ongoing debate about new measures continues. at times when trades-offs become difficult and even contentious, revisiting the guiding principles provides an important check for decision makers. the guiding principles that have guided development of the program are presented on the·following page. 2006] advancing quauty through collaboration 463 vision the achievement of breakthrough improvement in healthcare performance. central goal the overall goal of pay for performance is to significantly improve physician group performance in quality of health care and patient experience through public recognition and financial reward. core principles collaboration p4p is accomplished through purchasers, health plans, physician groups and consumers working together. measurement the measurement set is comprehensive and dynamic, including measures of clinical quality, patient experience, and infrastructure to support patient care. continuous evaluation will ensure alignment, relevance and effectiveness, raising the bar on performance over time. reward health plans will offer fmancial incentives tied to performance results. the fmancial incentives will be significant and sustained to promote performance driven organizations and justify investment in system reengineering. accountability all stakeholders have a role: • purchasers will promote health plan participation in p4p. • physician organizations will implement appropriate internal performance measurement systems, including individual physician measures. • a public scorecard will report physician group performance for consumers and providers making informed choices. program objectives 1. strategic selection criteria include measures that are: a. clinically relevant b. affect a significant number of people c. scientifically sound and tested before implementation d. feasible to collect using administrative data 464 indiana health law review [vol. 3:453 e. physician groups and health plans ·can impact f. capable of showing improvement over time g. are important to california consumers h. aligned with national measures (when feasible) 2. system reform encourage system re-engineering over incremental improvement. move from an individual disease management approach to cost-cutting measures and reward better outcomes, customer service, structure and efficiency for greater change and consumer relevance. apply risk adjustment so that payment reflects population mix and rewards better performance with patients who require special care. 3. consumer-relevant add customer service and other credible measures that evaluate better service to members, administrative efficiency and quality-related utilization. 4. predictabihty and stability ensure predictability and stability in the measurement set. phase-in multiple part measures, moving from process to outcomes as appropriate. leave each measure in the set for at least three years. evaluate annually to adjust based on experience, including weighting and specifications. consider testing for one year when measures have not been used before. s. standardize for comparison provide the greatest comparability between physician groups and enhance consumer and provider benefit by having participating health plans use a standardized measurement set. 6. align what matters work to better align pay for performance measures among plans, providers and purchasers with the measures required by accreditation, health employer data information system ("hedis"), public and private purchasers and regulators, including movement to individual physician level performance. f. moving from pilot to implementation in late 2001, an organizational structure was developed to design and operate the program. a steering committee was organized to provide program governance, along with a technical committee to design the measurement set and manage issues related to data collection, analysis and reporting. the technical committee, which was chaired by stephen shortell, ph.d., the dean of the school of public health at u.c. berkeley, developed an initial performance measure set in 2002. 2006] advancing quality through collaboration 465 technical development of a meaningful, credible set of performance measures is one of the most important roles that iha plays in the pay for performance program. selection of appropriate practice guidelines that are both clinically relevant and administratively feasible requires a significant amount of technical work. iha formed a prestigious technical committee of experts and stakeholders to lead this work. enhancing this effort are individuals from the national committee for quality assurance ("ncqa") and the pacific business group on health, who provide staff support to the committee. ncqa was also awarded the task of data collection and aggregation. a california based company, diversified data design, which has been engaged in collecting and consolidating information for california physician organizations for over a decade, contributes to the data collection effort. dean shortell's impartiality was crucial in guiding the stakeholders through the difficult process of measure selection. by the end of 2001, the initial measure set was approved by the steering committee and released for public comment, an important process step allowing all the affected stakeholders a chance to voice an opinion. by early 2002 the measure set was completed. at this point it was time to move forward with testing and implementation. a key guiding principle of the program is a test period for new measures before they are incorporated into the actual measure set for reporting and payment. this required the initial measure set to be tested in its entirety before implementation. in 2002, forty-nine physician groups agreed to participate on a voluntary basis in a pilot involving clinical data collection for the recommended measure set. groups submitted data for a single measure or multiple clinical measures. although many groups had data collection systems in place, forty-three percent had never previously captured information for these clinical measures. the profile of the physician groups participating in the pilot included thirty-nine percent ip a, twenty-nine percent medical group, fourteen percent mixed medical and ip a, and eighteen percent groups managed by a sub­ contracted management service organization ("mso"). the participating test groups had patient enrollments ranging from 7,500 to 225,000 patients. the results of the first year pilot revealed that the top performers were spread out among many groups; in fact, forty-four percent were in the top performing quartile for at least one measure. following testing and analysis of the pilot results, the technical committee made final recommendations for the measure set. physician group performance was measured both individually and in aggregate in 2003, with incentive payments and public reporting following in 2004. today, three program measurement years (2003-2005) have been completed, with incentive payments and reporting for the first two years of the program. many key challenges have been addressed during this time and adjustments have been required, including an occasional reversal due to new 466 indiana health law review [vol. 3:453 information or technical difficulties. throughout the process, participating health plans and physician organizations have shown commitment, flexibility and a steady spirit of collaboration. ill. the power of multiples an organizing force behind the development of the pay for performance program is the uniform evaluation of a physician group's performance across multiple health plans and measures. to maximize the leverage of this approach, each participating health plan is encouraged to use a uniform measure set to examine performance based on the physician group's overall, combined patient population. this concept is in contrast to more traditional approaches in which an individual health plan evaluates and rewards physician group or individual physician performance in isolation. by creating a multiple of combined payment from seven health plans, physician groups can invest capital and staff attention in specific aspects of care management and data collection, knowing their efforts will receive meaningful and reliable measurement and reward. a. data aggregation physician engagement is fostered by active participation in measure selection, assuring the validity of the measures. equally important is the aggregation of data by physician groups across all participating health plans, enhancing the reliability of the reported results. the power of aggregated data is an underappreciated concept it dramatically enhances the sample size and credibility of results. this concept is best understood with examples. the largest participating plan in the iha program has about 1.4 million members, less than twenty­ three percent of the entire 6.2 million patient population. even a plan of this size using its own data often lacks sufficient sample size to allow for statistical reliability. furthermore, data from a single plan often cannot provide an accurate picture of the group's entire patient population. herein lies the basis of the complaint regarding "dueling report cards," which motivated groups to push for a uniform program. the use of aggregated data provides demonstration of the power of multiples. to illustrate this point, compare the number of measures and groups a plan can confidently report using its own data versus aggregated data. for the 2004 measurement year, those plans with less than 500,000 hmo enrollees could on average report against all clinical measures for only sixteen percent of its contracted physician groups using their own data, versus seventy percent using the aggregated dataset those plans with more than 1 million hmo enrollees on average could report against all clinical measures for thirty percent of its contracted physician groups using their own data, versus sixty­ five percent using the aggregated dataset. 2006] advancing quality through collaboration 467 health plans participating in the program have come to appreciate the practical advantages of using aggregated versus individual plan data. for measurement year 2004, six of the seven participating health plans based their incentive payments on the aggregated dataset which incorporates the results of the entire 6.2 million patient population. this not only allows for more extensive reporting, but gives the physician organizations much greater confidence in the reliability of the results and incentive payments. b. use of the recommended measurement set the power of multiples is only valid to the extent that participating plans use the recommended uniform measure set. a variety of issues, primarily philosophical and contractual, have caused plans to adopt the uniform measure set in varying degrees and with different timing. in 2003, some plans adopted the iha recommended measure set in its entirety and exclusive to other quality performance measures, while other plans partially implemented the recommended measure set and/or added their own measures. by 2005 most of the plans had largely adopted the lha recommended measure set and had added other measures of special interest. n. performance measurement the performance measurement set has three domains: clinical, patient experience, and information technology. there has been an ongoing debate concerning the relative weighting of these domains for the purpose of calculating incentive payments. initially, the measurement domains were weighted clinical at fifty percent, patient experience at forty percent, and it investment at ten percent. in the second and third years weightings were adjusted. 2 the current weighting is: • clinical at fifty percent • patient experience at thirty percent • information technology at twenty percent the recommendations for payment weightings remains dynamic and will be adjusted in conjunction with performance measure set changes. in the clinical measurement domain, about half of the indices are for preventive measures. the remaining clinical measures are in chronic care management. the current clinical measures are primarily focused on process measurement, but the use of outcome measures, such as control for hbal c and ldl level, is an increasing focus of measure development. 2. see generally, e.g., cheryl l. damberg et al., paying for performance: implanting a statewide project in california, 14 quauty mgmt. health care 66 (2005). 468 indiana health law review [vol. 3:453 in the patient experience measurement domain there were initially four areas: communication with doctors, overall rating of care, specialty care, and timely access to care. in the 2005 measurement year, care coordination was added to this domain to focus on the efforts of physician groups to improve patient and population care management. this domain is currently measured and collected through the consumer assessment survey ("cas"). many physician groups participated in the cas and were familiar with the survey tool at the onset of the pay for performance program, but many more have been inspired to join cas. in 2002, eighty physician groups participated in the cas. by 2005, this figure more than doubled to 179 groups involving 35,000 physicians. the existence of an established consumer/patient survey provides the advantages of a ready made tool with longitudinal data that can feed quality improvement efforts. it also minimizes the practical, operational challenges of launching a new survey. these advantages must be considered in the context of conflicts that naturally result as the original purpose and goals of the survey intersect with the objectives of pay for performance measurement. at the onset of the pay for performance program development, infonnation technology was not a consideration for the measurement set. ultimately, it was decided that if truly "breakthrough improvements" were to be achieved, structural investments in information technology were essential. this resulted in the decision to reward groups for making this investment. therefore, the information technology measurement domain was added. groups must be able to show capabilities in either of two categories to earn incentive payment rewards in the infonnation technology measurement domain. they are: clinical data integration at the group level and clinical decision support at the point of care. an example of clinical data integration is the creation of data registries which integrate physician encounter, phannacy and other data sources for specific chronic care patient populations at the physician group level. clinical decision support at the point of care includes a number of qualifying activities such as telemedicine applications and wireless point of care e-prescribing. 2006] advancing quality through collaboration 469 table 1: evolution of iha p4p chnieal measures 2003 measurement year i 2004 measurement year i 2005 measurement year i 2004 reporting year 2005 reporting year 2006 reporting year i. childhood i. childhood immunizations l. childhood immunizations (wl24-month continuous immunizations (w/ 12-month continuous enrollment) (w/ 24-month continuous enrollment) 2. cervical cancer screening enrollment) 2. cervical cancer 3. breast cancer screening 2. cervical cancer screening 4. asthma management screening 3. breast cancer 5. hba1c screening 3. breast cancer screening 6. hbalc control screening 4. asthma management 7. ldl screening 4. asthma management 5. hbalc screening (patients w/ cardiac event & 5. hba1c screening 6. ldl screening diabetics) 6. hbaic control (patients with cardiac 8. ldl control <130 7. ldl screening event only) (patients wl cardiac event & (patients w/ diabetics) cardiovascular 9. chlamydia screening conditions & diabetics) 8. ldl control <130 (patients w/ cardiovascular conditions & diabetics) 9. chlamydia screening 10. appropriate treatment for children with upper respiratory infection encounter threshold: encounter threshold: encounter threshold: <:2. 7 enc./member year* <:3.25 enc./member year* <:3.25 enc./member year* payment weighting: 50% payment weighting: 40% payment weighting: 50% • to ensure that reasonably complete data is used to create clinical scores, data streams with fewer than the specified number of encounters per member year will not be used to create the clinical rates from aggregating plan-supplied data. 470 indiana health law review [vol. 3:453 table 2: evolution of iha p4p patient experience measures 2003 measurement year i 2004 measurement year i 2005 measurement year i 2004 reporting year 2005 reporting year 2006 reporting year 1. specialty care i. specialty care 1. specialty care 2. timely access to care 2. timely access to care 2. timely access to care 3. doctor~patient 3. doctor~patient 3. doctor~patient communication communication communication 4. overall ratings of care 4.0verallratingsofcare 4. overall ratings of care 5. care coordination payment weighting: 40% payment weighting: 400/o payment weighting: 30% these measures are composites based on questions from california's consumer assessment survey. for measurement year 2004 and beyond, the composite construction was modified to be consistent with the composites reported publicly in the consumer scorecard posted by the state office of the patient advocate. 2006] advancing quality through collaboration 471 table 3: evolution of iha p4p information technology investment measures 2003 measurement year i 2004 measurement year i 2005 measurement year j 2004 reporting year 2005 reporting year 2006 reporting year 1. lhtegrate clinical 1. integrate clinical no change from previous electronic data sets at electronic data sets at group year group level for population level for population management management activities include: activities include: • patient registry • patient registry • actionable reports • actionable reports • hedis results • hedis results 2. support clinical 2. support clinical decision decision making at point making at point of care of care through electronic through electronic tools tools activities include: activities include: • electronic prescribing • electronic prescribing • electronic check of • electronic check of prescription interaction prescription interaction • electronic retrieval oflab • electronic retrieval oflab results results • electronic access of • electronic access of clinical clinical notes notes • electronic retrieval of • electronic retrieval of patient reminders patient reminders • accessing clinical findings • electronic messaging requires two activities, at requires four activities of least one in each measure; which at least two are in each activity is worth 5% measure 2; each activity is worth 5% payment weighting: 10% payment weighting: 20% payment weighting: 20% 472' indiana health law review [vol. 3:453 v. the "pay" in payforperformance the institute of medicine report, crossing the quality chasm, outlined a business case for quality which included broad recommendations for incentives to enhance quality. 3 california stakeholders attempting to implement these recommendations had a variety of standardized performance measures to draw upon, such as the ncqa hedis measures. however, standards for physician incentive payment methodologies were lacking. individual health plans had experimented with incentive payments, but a broadly accepted standard for payment methodology had not emerged. the absence of any uniform approach to incentive payment was further complicated by concerns about anti-trust. collaborating on a uniform set of performance measures was allowable, but any agreement on a specific payment amount or payment methodology raised potential risks. expert anti­ trust counsel was engaged to provide guidance and establish boundaries for iha and its stakeholders. the result was a decision to avoid specific recommendations by iha about payment amounts or specific payment methodology. rather, recommendations were made for a payment timeline, measure set weightings and general payment methodology. to preserve its financial autonomy, each respective plan considers these recommendations and individually determines its own methodology for incentive payment eligibility and amount of payment. a. timeline for data collection and payment payment is typically made directly by health plans to physician organiza­ tions within six to nine months after completion of a measurement year. payments for measurement years 2003 and 2004 have been completed, and payments for measurement year 2005 are expected to be completed by the end of october 2006. the lag between completion of the measurement year and payment reflects the time needed to complete data collection, required audits, and the aggregation of data sets across participating health plans and physician groups. ncqa contracts with iha to act as intermediary to aggregate informa­ tion across health plans and physician organizations. physician organizations can rely solely on health plan data or supplement this data through self­ reporting. if performance for a specific measure is reported by both a health plan and a self-reporting group, ncqa will accept the more favorable score. self-reporting groups totaled forty-two for the 2003 measurement year, increasing to eighty-two groups for the 2004 measurement year. all data 3. seeinst.ofmed.,crossingtiiequailtychasm:anewhealthsystemfortiie 2lstcen'rury(200l). 2006] advancing quality through collaboration 473 . . submitted requires an independent audit prior to acceptance by ncqa, arid these audits must be performed by an ncqa approved auditor. while self-reporting was initially expected to be an interim approach, it will most likely continue for the foreseeable future due to the nature of data collection in california's capitated, delegated environment. b. payment amounts total incentive payments to physician groups equaled $3 7.4 million for the iha metrics in the 2003 measurement year. for this first year, payouts for the clinical and patient experience domains were relatively equal at about $17 million each, with the balance of about $3 million paid for information technology. payouts varied considerably by health plan. this variation reflects both the differences in enrollment and maximum payment thresholds of participating health plans. an average per member per month (''pmpm'') amount provides a benchmark to compare payment amounts across health plan. these average amounts ranged from a low of$ .09 pmpm to a high of $.84pmpm.4 as we go to press, total payments in 2005 for the second measurement year, 2004, are estimated to be about $54 million, reflecting substantial payment increases by several plans and the addition of a plan. table 4: total incentive payments by domain by year doljarij paid .(inmiuiom) ~0 25 z<t 15 to 5 0 2003 2004(estimated) payments are estimated at about $26 million for the clinical measures, approximately $22 million for the patient experience and the balance of about $6 million for information technology. variation in average payment by plans 4. integrated healthcare ass'n, transparency report on 2004 payouts (revised), ht1p:/lwww.ihaorglftransp.htm (last visited apr. 4, 2006). the reports were developed by the rand corporation and university of california. berkeley, hass school of business. 474 indiana health law r.zymw [vol. 3:453 . . · continuect estimated to range from $.05 pmpm to $l.59 pmplli across the entire physician group population. 5 payments to individual physician groups ranged from none to $4.50 pmpm. across all groups average incentive payment for the second program year equaled about 1.5% of total physician group compensation. this is relatively low compared to average pay for performance payments reported in a national survey. 6 the subject of active debate, the five year plan presented later in this document recommends increasing payment up to ten percent of total physician compensation. at the onset of the program, the intention was for health plans to fund incentives without lowering base physician group reimbursement. increasing incentive payments up to ten percent of total com­ pensation will require alternative approaches which have not been resolved. the pay for performance incentive payments do not represent the total incentive amounts paid by plans to physician groups. health plans also pay incentives for non-iha sponsored quality measures and to promote better data collection, generic pharmacy utilization, and other purposes. at the request of its stakeholders, iha engaged the rand corporation to develop a ''transparency report" on payment amounts and methodology by health plan. this report is available for measurement year 2003 at http://www.iha.org. c. payment methodologies health plans have progressively adopted the recommendations developed by iha during the measurement years 2003 through 2005. table 5 presents an overview of the general payment methodology implemented by participating health plans for measurement year 2004. 5. integrated healthcare ass'n, transparency report on 2005 payouts, http://www.iha.orglftransp.htm (last visited apr. 4, 2006). the reports were developed by the rand corporation and university of california, berkeley, hass school of business. 6. geofbaker, national webcast on pay for performance issues and trends (nov. 17, 2005) (on file with integrated healthcare ass'n). 2006] advancing quauiy through collaboration 475 table 5: payment methodology by particlpating health plans no no no no based on no pervious yean yes, yes, yes, yes, for yes, ljfoiiiis groups in each ljfoiiiis insotbto the 20th insothto tooth tooth no pen:entile pen:entile paid on paid on sliding sliding scale. no, pay for yes yes yes yes mostiha yes clinieal measures no, pay for patiedt yes yes yes yes satisfilction yes ubiu&own no, do no, do dot not pay yes yes yes pay for it. yes for it. yes yes yes yes no yes no, wejpts acljusted for no, wejpts yes yes patiedt yes adjusted experience sligbtty. and it. 476 indiana health law review [vol. 3:453 vi. public reporting and program results transparency via public reporting of physician group performance is a key part of the pay for performance program. to avoid creating yet another "dueling report card," llia explored existing reporting efforts for potential collaboration. the california state office of the patient advocate ("opa") creates an annual, consumer-focused public score card for hmo performance, so it was a likely place to begin. opa agreed, and the result is a clinical scorecard for california physician groups. llia provides the clinical pay for performance aggregated data to opa for its public score card of physician groups. the use of the data is governed by the pay for performance steering committee. the layout and statistical underpinnings of the report format are the responsibility of op a, with input fromllia. the physician group public score card is available in multiple media and languages. a web-based version is located on the opa website at http://www.opa.ca.gov (figure l ). consumers select a county to see the overall performance of all the groups that provide services in their area. they can then scroll down to see performance on each measure for each group. print versions are available in english, spanish and chinese, and are distributed through major drug store chains and public libraries. physician groups have reported that they are in favor of public reporting and that it provides strong motivation for improvement. 2006] advancing quality through collaboration 477 figure 1: sample of web-based physician group pub lie seore eard rating key excellent*** good ** fair * poor"'k medical group ratings although kaiser pennanente does not participate in the financial incentive portion ofpay for perfonnance, the kaiser medical groups expressed interest in participating in the public score card. the steering committee was in favor, on the condition that the extensive kaiser medical groups be reported in service areas comparable to other participating physician groups. as a result, kaiser northern california reported five service areas on the 2005 score card, and kaiser southern california plans to report twelve service areas starting with the 2006 score card. consequently, consumers have a more complete picture of the quality and patient satisfaction ratings for all of the physician groups in their geographic area. a. program results two complete years of results are now available. "breakthrough improvement'' has not been achieved, but physician groups have collectively improved across each measure in all three domains from year 1 to year 2. undoubtedly, some of the improvement is due to better data collection, as this has been a major focus of the physician groups. however, program evaluators indicate that there were also true gains in quality improvement based on both the improved results and interviews with leadership at representative physician groups. 478 indiana health law review [vol. 3:453 table 6: sample of improvements in clinical measures table 7: patient experience: improvement across many physician groups b. clinical results eighty-seven percent of the groups reporting all clinical measures improved their overall clinical score by an average of 5.3 percentage points from year 1 to year 2. performance on the individual clinical measures improved between 1.1 and 10.2 percentage points (table 6). actual rates are still slightly lower than the national average. but the gap is decreasing. c. patient experience results in the second year, improvement also occurred in overall patient experience performance, with sixty-six percent of groups increasing by an average of 1.2 percentage points. improvement was seen in each of the survey questions used in both 2003 and 2004 that comprise patient experience measures of overall ratings of care and specialty care, as presented in table 7. 2006] advancing quallly through collaboration 479 many physician groups decided to participate in the consumer assessment survey ("cas'') used to measure patient experience after pay for performance began. participation increased thirty-eight percent, from 130 groups in 2003 to 179 groups in 2005. looking only at groups who have participated in cas since the beginning of pay for performance, their improvement ranged from three to five percentage points, substantially higher than the improvements for the entire population of physician groups. this suggests that continued participation promotes greater improvement. d. it adoption results the most dramatic improvements were seen in it adoption. from year 1 to year 2, there was a fifty-four percent increase in the number of groups qualifying for at least partial it credit. in year 2, over half of the groups reported some it capability, versus only one third for year 1. of the groups who received no credit for it in year 1, thirty-four percent demonstrated some it capability in year 2. 7 in general, physician groups have demonstrated a greater ability to integrate electronic clinical datasets for population management than to use decision support technology at the point of care (table 8). nearly forty percent of physician groups are able to integrate datasets to generate actionable reports or hedis results, and over a quarter have a disease registry or data warehouse. compare this to the approximate ten percent of groups that produce electronically generated prescriptions, automatically check drug to drug interactions before prescribing, or generate preventive or chronic care reminders electronically. 7. t. williams et al., pay for petformance and its influence on the use of information technology in physician organizations, 21 j. med. prac. mgmt. (forthcoming 2006). 480 indiana health law review table 8: improved 2004 it adoption results accessing clinical notes of other physician preventive & chronic care reminders 11.6% 7.0% [vol. 3:453 21.3% 83.5% 12.00.4 although there has been a remarkable acceleration in the adoption of it to support care management, the reality remains that nearly half the physician groups in california have not demonstrated any capacity in this area. e. correlation between clinical and it performance adoption of it systems for purposes such as building patient registries for at-risk or chronically ill patients and use of electronic decision support systems at the point of care offer potential improvements in the quality of care. the physician groups who received full credit on the it measures had average clinical scores that were nine percentage points higher than physician groups who showed no evidence ofit adoption. further progress toward the ultimate objective of breakthrough improvement will require adoption of many program enhancements outlined later in this report, including increased incentive payments as the measure set becomes more comprehensive and performance expectations escalate. 2006] advancing quality through collaboration figure 2: correlation between clinical and it performance 80 75 70 65 60 55 50 cl1n1calaveragoby it total score, 0% 5% 10% 15% 20% it total score vll. management of the program 481 management of the program has naturally developed over time, and is not static. at present, the organizational and administrative structure is as follows: a. governance the iha board provides oversight and stewardship of the program, delegating active program governance to a steering committee composed equally of members from three classes: health plans, physician organizations and at-large. the at-large member class includes purchaser and consumer representatives, plus individuals from organizations that contribute technical and policy expertise to the committee, such as the center for disease control, local quality improvement organizations ("qio"), and state government. the steering committee meets quarterly and determines policy (e.g. changes to measurement set) and strategy (e.g. program expansion to new populations). a planning committee was recently formed, reporting to the steering committee, composed of two members from each member class for a total of six members. this group meets monthly to consider key policy and strategic issues and to make recommendations to the steering committee. a technical committee provides oversight of development of the measurement set, data collection and related technical issues. this committee includes representation from health plans, physician organizations, purchasers and technical experts. it is charged with developing the measure set, measure specifications and approaches to data collection. this committee meets quarterly. 482 indiana heal til law review [vol. 3:453 the five year plan includes a recommendation to form a new payment committee to focus on issues related to payment amount and methodology, subject to creation of a "s8fe haven" to allow discussion to occur without risk of anti-trust concerns. this important step is needed to allow an active dialogue about the proper alignment of measures, rewards and expectations. b. administration a team of technical staff supports the work of all the. governing committees and includes llia staff and staff contracted by llia from the pbgh and ncqa. this team plays a critical role in supporting the governing committees and program administration. the evaluation team consists of researchers from the rand corporation and u.c. berkeley's haas school ofbusiness. they are conducting a five year evaluation of the program with funding provided by the chcf. the following components of program activity require funding: 1. technical support-measure development and testing 2. data aggregation-collecting, aggregating and reporting performance data 3. governance committees-meeting expenses and consulting support services 4. stakeholder communication-web casts, newsletters and annual meeting 5. progtain administration-direct and indirect iha staff and related expenses 6. evaluation services-program evaluation and consultative services initial grant funding provided by the chcf was critically important to support performance measure set development and testing. because the program was ground breaking, new measure development for the information technology domain was required, and extensive testing was needed prior to the use of existing hedis measures at the physician group level. a large pilot was conducted during 2002 involving voluntary data collection for forty-nine physician groups before launching the program. the chcf also funded a five-year program evaluation (2003 2007) and ongoing technical support on a step-down basis through 2007. total grant funding provided by chcf for various aspects of the program exceeds $1 million to date, with total funding committed through 2007 projected to exceed $2 million. the program-specific and evaluation funding by chcf was done in partnership with the robert wood johnson foundation as part of the national rewarding results initiative. this initiative supported seven unique pay for performance programs around the country and fostered communication between the respective programs. 2006] advancing quauty through collaboration 483 glaxosmithk.line (gsk) has provided on-going financial support for activities related to governance committees and stakeholder communication. the participating health plans have funded data aggregation through annual fees based upon a pro-rata share of program population membership. as grant funding begins to step down, program stakeholders have sought a mechanism to provide ongoing program funding. to accomplish this, an "administrative surcharge" was adopted. this is a surcharge against bonus amounts paid by the health plans to the physician organizations. the initial surcharge equals 7.5 cents per member per year or $465,000 annually (7.5 cents x 6.2 million program members). as grant funding diminishes, the intention is to increase the surcharge to incorporate total annual program expenses. it is important to note that the program uses only electronic data for clinical measurement, avoiding the high costs of patient chart review, and an already existing survey instrument for patient experience measurement. vll. looking ahead: the next five years (2006201 0) in 2004 the steering committee formed a planning committee to develop a five year plan for the program. the committee developed initial recommendations and received stakeholder feedback that was ultimately incorporated into a set of recommendations formally adopted in late 2005.8 during the course of this process, a number of recommendations put forward by the planning committee were adopted and are in various stages of implementation. examples include: the decision to expand pay for performance into medicare advantage, development of efficiency measures, development and testing of overuse measures, action to implement a surcharge to fund program administration, steps to strengthen program governance, and development of a national pay for performance conference. the final product of this process was a revision of the program mission, priorities, and recommendations. program mission create breakthrough healthcare performance by promoting an integrated, organized, and efficient delivery system through alignment of incentives amongst all stakeholder groups. 8. integrated healthcare ass'n, pay for performance five year plan, http://www.iha.org/wpapers.btm {last visited apr. 4, 2006). 484 indiana health law review [vol. 3:453 program priorities the planning committee possesses a strong sense of urgency to drive an aggressive agenda, particularly over the next two to three years. an increased pace of program development is deemed necessary for the following reasons: • concerns by purchasers and health plans that continuing the current narrow measure set will promote ''teaching to the test," rather than advancing quality improvement. • potential lack of engagement by plails and purchasers if efficiency measures are not adequately emphasized. • potential lack of engagement by providers if incentive payments are deemed inadequate. • rapid advances in measurement science. three major priorities identified by the planning committee include: 1. aggressive expansion of the measure set, which promotes integrated and efficient care delivery and leverages advances in measurement science. 2. increased financial incentives to facilitate perfonnance breakthrough. 3. strengthened administration to support an increasingly sophisticated program. it became clear as input was received :from various stakeholder groups that expansion of the measure set should not be based solely on a target number of measures. rather, expansion should be based on the right selection and a manageable number of measures each year, with increasing focus on healthcare outcomes, introducing them at a pace that encourages physician groups to carefully design efforts that support the goals of the program. input :from the health plans emphasized the importance of also considering appropriate use of resources and the total cost to care for a population. not only is this one of the institute of medicine's six healthcare perfonnance domains,9 but it is also necessary for health plans to be able to make a business case for expanding their budget for pay for perfonnance incentive payments. this should be a two dimensional approach, with a correlation between cost and perfonnance. 9. see inst. of med., supra note 3. 2006] advancing quality through collaboration 485 recommendations 1. increase incentive payments proportional to improvements in performance outcomes. a. increase incentive payments to up to ten percent of total physician compensation by 2010. b. incorporate risk adjustment into capitation. c. pay for improvement on an interim basis. d. create a "safe haven" to advance consistent payment methodologies. 2. aggressive development and expansion of the performance measurement set. a. a comprehensive clinical domain that incorporates outcomes and specialty care. b. addition of an efficiency domain, including appropriate resource use measures. c. revise the patient experience domain and shift to a methodology with more meaningful results for physician groups. d. expansion of the information technology domain to a broader it­ enabled "systemness" domain that fosters integrated care processes. e. expansion of the measurement set to incorporate medicare advantage. 3. strengthen p4p administration to support an increasingly sophisticated program. a. use the "administrative surcharge" as an initial step to develop a self-sustaining business model by 2008. b. use of the common, aggregated dataset by all participating plans for incentive payment calculation by 2006. c. incorporate mechanisms to speed the consensus-based decision making process, while maintaining multi-stakeholder governance. 4. public reporting, research and public relations a. continue opa collaboration. b. support use of aggregated dataset. c. approve use of data for selective research projects. d. develop public relations capability. ix. lessons learned rna and california pay for performance program stakeholders are often asked, "what lessons have you learned?" this important question generates a variety of responses, but consensus on some key points has emerged. 486 indiana ileal til law review [vol. 3:453 begin by developing a set of guiding principles upon which all stakeholders can agree, and look to them when faced with disagreements. • set ambitious long-term performance improvement objectives, but modest short-term process goals. • trust is the glue that binds collaboration, and it is best developed through mutual achievement. • start with a limited number of measures at the program's onset. all stakeholders have limited capacity and will respond if expectations are reasonable. • performance measures are the "tip of the iceberg," with unending detail beneath in the form of measure specifications, barriers to data collection, and inevitable inconsistencies requiring practical solutions. therefore, test measures prior to implementation. • · seek ways to leverage the ''power of multiples" through uniform measurement, common reporting, data aggregation, and payment by multiple sources of funding. especially seek to measure, pay and report at the highest organizational level (e.g. physician group vs. individual physician) and with the largest population (e.g. multiple payers/purchasers vs. individual). • payment incentives are indeed a powerful catalyst and motivator. public and peer recognition are also important incentives for · performance not to be underestimated. • a neutral conveyor that represents all stakeholder groups equally is important for building trust and collaboration. • consensus decision making can be painfully slow, but essential. physicians must believe measurement is fair, and· payers and purchasers must believe payments can be justified. • transparency in all aspects of the program, including . governance and reporting, enhances trust among participants. • there is no substitute for actively engaged leaders in the decision making and governance process. x. application beyond california california has unique characteristics in the organization of its medical delivery system. most notable is the prevalence of organized, capitated 2006] advancing quauty through c<>u.aboration 487 physician groups and the multitude of large commercial payers, with no one dominating the market. these factors might dissuade observers :from attempting to replicate the california pay for performance model or similar approaches in other communities. however, many key elements of the program are independent of delivery system characteristics. this is evidenced by the alignment of many of the program's guiding principles and "lessons learned" with recent attempts to develop national guidelines for pay for performance programs. 10 the purpose of this report is to promote pay for performance. we have demonstrated that in our highly fragmented u.s. healthcare system, broad­ based quality initiatives can be operated successfully. fundamental components of the california pay for performance program are replicable in most communities, and the success in california should serve as an inspiration for any group attempting to advance healthcare quality improvement in their community. this report is also meant to inspire policy makers and leaders both locally and nationally to consider the opportunities that begin with collecting community-wide population data and using it to measure and incentivize performance. why not collaborate to collect and aggregate data across payers, both public and private, and use that information in combination with uniform measures to create incentives, reward performance and report results publicly? why not use organizations and structures that pre-exist in communities, whether they are health plans, employers or physician otganizations, to lead such efforts? why not utilize existing capabilities, such as quality improve­ ment organizations, to gather data on a community, state, or regional level from all payers? why not begin to build local infrastructure and capacity to collect data, measure performance, pay and report while the national efforts to develop uniform measures evolve? hopefully, this report and the dialogue at the national pay for perfor­ mance summit (los angeles, february 2006) will inspire other communities to raise these questions and help to advance understanding of the practical realities involved in creating a community-wide pay for performance program. it is our sincere hope that this will contribute to the groundswell effort emerging in this county to "do something" to realize the potential of our system ofhealthcare. 10. christopher b. forrest, victor v. villagra & james e. pope, managing the metn'c versus managing the patient: the physician's view of pay for performance, 12 am. j. managed care 85, 85-87 (2006). an athlete's right to privacy regarding sport­ related injuries: hip aa and the creation of the mysterious injury james blake hike • table of contents i. introduction ................................................................................. 48 a. the issue .................................................................................... 49 b. roadmap .................................................................................... 50 ll. health information portability and accountability acr. 51 a. general history .......................................................................... 51 b. necessary definitions and covered information ....................... 52 1. protected health information .............................................. 52 2. what constitutes a "covered entity"? ............................... 53 a. intercollegiate athletic community ................................ 53 ·b. professional athletic community ................................... 54 3. "minimum necessary" disclosure ...................................... 54 4. the role of authorization .................................................... 55 a. identification of the party authorizing disclosure ......... 56 b. a description of the protected health information authorized for disclosure ............................................... 56 c. identification of the party(s) authorized to make use of the disclosures ............................................................... 56 d identification of the party(s) authorized to receive the disclosures ..................................................................... 57 e. a description of the exact purpose for disclosure ......... 57 f. a listed date or event causing the authorization to expire ............................................................................. 57 g. the date in which the individual signed the authorization ................................................................. 57 m. interests at play ......................................................................... 58 a. the athlete's interest in phi confidentiality ............................. 58 b. the organization's interest in running a business and providing information to the media and the public .................. 60 1. a sense of community ......................................................... 60 2. taxing the public to build a new stadium or relocate ....... 61 3. the indianapolis colts ........................................................ 62 4. the green bay packers ....................................................... 64 • j.d. candidate, 2009, indiana university school oflaw-lndianapolis; b.s., 2006, manchester college. 48 indiana health law review [vol. 6:47 c. the public's interest in obtaining information and knowledge about individuals who have placed themselves in the public eye ............................................................................................. 66 n. an atiempt at compliance: organizational models .......... 67 a. national basketball association collective bargaining agreement .................................................................................. 67 b. national football league collective bargaining agreement.. .. 68 c. national collegiate athletic association ................................... 69 1. butler university sports medicine standard authorization form .................................................................................... 69 2. notice plus informed consent model .................................. 70 d. national athletic trainers' association ..................................... 70 v. public policy rationale ............................................................. 71 a. the promotion of betting lines and gambling ......................... 71 b. contractual waiver of protected health information ................ 72 1. non-sports-related injuries .................................................. 72 2. sports-related injuries ......................................................... 73 3. expiration ............................................................................ 73 c. blanket authorizations ............................................................... 74 vi. argument ....................................................................................... 7 4 a. balancing of interests ................................................................ 75 b. authorization .............................................................................. 7 5 c. public policy .............................................................................. 76 d. organizational education .......................................................... 76 vii. conclusion .................................................................................... 76 i. introduction coming off of back-to-back seasons in which he compiled over 1700 yards and tallied 17 or more touchdowns, larry johnson had high hopes for the 2007-2008 national football league ("nfl") season.1 after spending the kansas city chiefs' ("chiefs") entire training camp negotiating a new contract, however, johnson began the season with a slight hamstring injury and never seemed to get going.2 in a november 4, 2008 game against the green bay packers, johnson limped off the field, putting no weight on his right leg. 3 from the moment johnson left the field, announcers and fans began to speculate. the subsequent actions taken by johnson and the chiefs organization led to the creation of a mystery injury. 1. larry johnson, http://www.nfl.com/playersllarryjobnson/profile?id=joh399484 [he­ reinafter johnson] (last visited jan. 28, 2009). 2. randy covitz, larry johnson frustrated by way his 2007 season played out, the kansas city star, jan. 30, 2008. 3. jason whitlock, chiefs season takes another strange twist, the kansas city star, nov. 4, 2007. 2009] an amlete's right to privacy 49 after johnson limped off the field on november 4th, the chiefs' organiza­ tion failed initially to issue a formal statement disclosing any specifics about the injury.4 additionally, johnson neglected to issue a statement as to the exact nature of his condition, noting only the severity of the initial swelling and the fact that the condition improved to where he could walk without a protective boots it is important to note that nfl organizations typically release informa­ tion relating to on-field injuries.6 when the chiefs' president, carl peterson, finally issued a formal statement, the information he provided remained ambi­ guous. peterson stated, "[i]f a patient doesn't want medical information out there, then (the doctor) is obligated, as we are, under the rules of illp aa [health insurance portability and accountability act], of not going into de­ tai1."7 fans became frustrated with the lack of information provided by the team, the media began to speculate when and if johnson would return, and fantasy football owners of johnson did not know whether they should drop or hold on to their top-five pick. 8 until recently, johnson and the chiefs kept everyone in the dark as to the exact nature of what turned out to be only a slight crack in one ofjohnson 's toes. 9 moreover, it remains unclear as to why the chiefs and johnson felt compelled to keep johnson's injury a secret. johnson's situation highlights some of the problems, concerns, and mis­ conceptions that arise when the sports industry addresses the health insurance portability and accountability act ("illp aa," alternatively the "act"). teams and organizations often struggle with what and how much information they can release to the public.10 as a result, fans and the media begin to speculate, which leads to the creation of a mystery injury. to best address the situation, one must weigh the importance of an individual's interest in protecting his or her personal health information with the interests of the athletic organizations, the media, and the public at-large. all things considered, sports organizations, with appropriate player authorization, should be permitted to release an ath­ lete's sports-related injury info~on without breaching the constraints of hipaa. a. thelssue since the introduction ofhipaa in 1996, the multi-billion dollar sports 4. stephania bell, all is not well in kansas city, (nov. 21, 2007), http://www.sports. espn.go.com/espnlpring?id=3121838&type=blogentry (last visited aug. 9, 2008). 5. /d. 6. covitz, supra note 2 (internal quotations omitted). 7. /d. 8. see james alder, types of fantasy football leagues, abour.com: football, http://football.about.com/od/fantasygames/alfantasyleagues.htm, for an explanation of fantasy football and the different league types (last visited sep. 13, 2008). 9. covitz, supra note 2. 10. seeid. so indiana heal111 law review [vol. 6:47 industry has been confronted by the need for a major overhaul in how it con­ ducts business.11 the department of health and human services ("dhhs") initially enacted hip aa in an effort to shield an individual's protected health information ("phf') from unauthorized disclosures to third parties, to improve the quality of health care by restoring trust in the health care system. and to pro­ tect and enhance the rights of consumers by providing access to their health care information.12 with application to both public and private entities, hip aa notably ''requires extreme confidentiality of most medical information."13 fur­ ther, hippa 's implementation has impacted the technology age and the use of electronic systems to keep track of medical records in general.14 with the sports industry, hip aa emphasizes the unavoidable exposure of the athlete-trainer relationship to the media. 15 hip aa's first purpose, shielding an individual's phi from unauthorized disclosures to third parties, has exhi­ bited the largest impact on sports organizations.16 as a result, those organiza­ tions have sifted through the initial misconceptions that surfaced upon implementation of the act and have developed working models for protecting an athlete's phi.17 b.roadmap this note discusses the models implemented by athletic organizations in an effort to comply with hip aa and protect the health information of athletes at both the professional and collegiate levels. to facilitate a better understand­ ing of the organizational purpose behind the models, section ii explains the general background information of the act, covers necessary definitions found within the act that pertain to athletic organizations, and offers an explanation of the information the act is intended to cover. section m offers an analysis of the different interests at play and weighs the importance of an individual's in­ terest in protecting his or her phi with the interests of athletic organizations, the media, and the public at large. section n introduces the different models 11. susan m. pitz, features: hip aa and tjre sports media: separating fiction from re­ ality, nevada lawyer, aug., 2003, at 12-13. 12. jd. at 12 (citing preamble to the health insurance portability act of 1996,65 fed. reg. 250 (dec. 28, 2000)). 13. susan k. menge, should players have to pass to play?: a legal analysis of imple­ menting genetic testing in the national basketball association, 11 marq. sports l. rev. 459, 468(2007). 14. seedavidr. morantz,hipaa 's headaches: a callforafirstamendmentexception to the newly enacted health care privacy rules, 53 kan. l. rev. 479, 481 (2005). 15. see generally pitz, supra note 11, at 13. 16. seeid. 17. jd. at 12-13 (notingthatafewofthecommonmisguidedreactionstohippa'simple­ mentation were questions over whether or not sideline reporters would be able to report injuries to the television audience, whether or not teams would be able to release injury reports to the media, and whether or not coaches would be able to discuss the injury status of an athlete with the team's athletic trainer). 2009] an athlete's right to privacy 51 that professional and collegiate sports organizations use in an effort to comply with the hip aa guidelines. section v discusses the different public policy arguments for and against releasing an athlete's injury information. finally, sections vi and vii argue that the current models and systems used by athletic organizations remain appropriate. sports organizations, with appropriate player authorization, should be allowed to release an athlete's sports-related injury information without breaching the constraints of hip aa. ii. health information portability and accountability act to facilitate a better understanding of the organizational motivation for implementing certain models or requiring specific procedures for the release of an athlete's phi, it is important to understand the details ofhip aa itself. this section explains the general background information of the act, covers neces­ sary definitions found within the act that pertain to athletic organizations, and offers an explanation of the information the act is intended to cover. a. general history hip aa purports to protect an individual's health information.18 in the late 1990s, lawmakers and administrative agencies developed the act in re­ sponse to the emergence of information technology and the electronic medical record.19 the act was created to ease growing concern among patients regard­ ing the confidentiality of phi records in an outdated paper record system.z0 additionally, the act sought to address patient concern about where patient medical information was going and who had access to it}1 congress approved the act in 1996.22 upon approval ofhippa,·con­ gress required the secretary of the dhhs to recommend privacy measures to congress within twelve months.23 following the dhhs secretary's recom­ mendations, congress allowed itself a span of three years to fully develop legis­ lation concerning the privacy of individually identifiable health information. 24 18. morantz, supra note 14, at 481. 19. !d. (referencing lawrence 0. gostin & james g. hodge, jr., personal privacy and common goods: a framework/or balancing under the national health information privacy rule, 86 minn. l. rev. 1439, 1440 (2002) (describing the ongoing nature of the health indus­ try's shift from paper to electronic records)). 20. !d. (referencing lawrence 0. gostin, health information privacy, 80 cornell l. rev. 451, 453-54 (1995)). 21. see id. (referencing gostin, supra note 20) (citing polling data that indicates 800/o of respondents believed that consumers had lost control over the use and circulation of their medi­ cal information and 85% of respondents said that protecting the confidentiality of medical records is an essential part of national health care reform). 22. !d. (referencing health insurance portability and accountability act of 1996, pub. l. no. 104-191, 110 stat. 1936 (codified at 42 u.s.c. § 201 (2003)). 23. !d. (referencing 42 u.s.c. § 264a (2003)). 24. morantz, supra note 14, at481 (referencing42 u.s.c. § 264(c)(1)(2003)). 52 indiana heal1h law review [vol. 6:47 as a condition of the three-year time allo1ment, congress mandated that if the deadline passed with no legislation, the secretary of the dhhs would be re­ quired to develop the appropriate guidelines.25 congress, however, missed its deadline.26 consequently, the secretary of the dhhs, donna shalala, issued the proposed rule in november 199~7 and the final rule in december 2000.28 in 2002, the new dhhs secretary, tommy thompson, issued a notice of pro­ posed rule making. 29 thompson issued the final rule, placing it into effect in august 2002.30 b. necessary definitions and covered information this sub-section highlights the important hip aa definitions pertaining specifically to sports organizations. it delves into what information hip aa seeks to protect, which organizations fall under the purviews of the act, the amount of allowed disclosure, and the role authorization plays in circumventing the act's requirements. in addition, this sub-section addresses key concerns, particularly why hip aa regulations apply to the sports organizations as a whole and not just to the team's physicians. i. protected health information the dhhs initially enacted hip aa in an effort to shield an individual's phi from unauthorized disclosures to third parties.31 an individual's phi in­ cludes any personally identifiable information concerning the past, present, or future physical or mental health or condition of an individual. 32 additionally, phi also includes the provision of health care to an individual and the past, present, or future payment for that provision of health care. 33 therefore, an athlete's health information, both related and un-related to participation in a particular sport, falls under the purview of hip aa. 34 as such, hip aa's pro­ tections extend to preventing the disclosure of the athlete's phi to media out­ lets, the fans, and other third parties outside the sports organization with which 25. ld. (referencing 42 u.s.c. § 264(c)(l) (2003)). 26. ld. 27. jd. (referencing standards for privacy oflndividually identifiable health information, 64 fed. reg. 59, 918 (proposed nov. 3, 1999)). 28. id. (referencing 65 fed. reg. 82, 462 (dec. 28, 2000)). 29. ld. at 481-82 (referencing 67 fed. reg. 14, 776 (proposed mar. 27, 2002)). 30. morantz, supra note 14, at481 (referencing67 fed. reg. 53, 182 (aug. 14, 2002)). 31. pitz, supra note 11, at 12 (citing preamble to the health insurance portability and accountability act of 1996, 65 fed. reg. 250 (dec. 28, 2000)). 32. morantz,supranote 14,at481 (referencingdianek.utzkoetal.,hipaa in rea/time: practical implications of the federal privacy rule, 51 drake l. rev. 411 (2003) (citations omitted) (providing a thorough analysis of the law's mechanics and definitions)). 33. jd. (referencing k.utzko et al., supra note 32). 34. seejunem. suujvan,hipaa:apracncalgumetolhbpluvacy and security of heal til data 5 (american bar association) (2004). 2009] an athlete's right to privacy 53 the athlete is associated. 35 2. what constitutes a "covered entity"? under the act, organizations must complete several different steps in a process largely dependent upon whether they are classified as a "covered enti­ ty. '.36 the determination of what type of organization or association classifies as a covered entity provides for much of the misunderstanding of the act, par­ ticularly in regard to who is responsible for compliance with the law.37 the regulations define a "covered entity'' as a health plan, a health care clearing­ house, or a health care provider who transmits any health information in elec­ tronic form. 38 insurance companies, medicaid, long-term care providers, employee welfare benefit plans, and portions of medicare also fall within the definition of covered entities,39 as well as organizations that process health data and provide billing services.40 the remaining inquiry is whether a professional or collegiate sports organization constitutes a covered entity under hipp a. a. intercollegiate athletic community initially, the intercollegiate athletic community assumed that hip aa did not apply to its universities.41 many universities assumed that they were ex­ empt from hippa regulation because they are subject to the family education rights and privacy act ("ferp a''), and hip aa expressly exempts activities regulated by ferpa.42 because hipaa distinguishes traditional from non­ traditional operations of universities, however, the universities' assumptions were wrong.43 specifically, hip aa exempts traditional university operations, such as student health centers run by university employees, but does not exempt non-traditional university operations.44 for example, the ferpa exemption would allow an athletic trainer to give information about a student athlete's pill to the coach because hippa classifies this action as a traditional university op­ eration!5 if an athletic trainer, however, gives an athlete's health information to the media and the media reports that information to the public, the ferp a exemption to hippa does not apply.46 hipaa classifies this situation as a 35. seeid. 36. pitz, supra note 11, at 13. 37. morantz, supra note 14, at 482 (referencing pitz, supra note 11, at 13 (discussing confusion about whether hip aa covers athletic teams)). 38. pitz, supra note 11, at 12-13 (citing 45 c.f.r. § 160.103 (2002)). 39. morantz, supra note 14, at 482 (citing 45 c.f.r. § 160.103 (2002)). 40. id. 41. pitz, supra note 11, at 13. 42. id. 43. ld. 44. id. 45. id. 46. ld. 54 indiana health law review [vol. 6:47 non-traditional operation-one that falls outside the traditional realm of treat­ ment 47 in the absence of necessary authorization, disclosure ofhealth informa­ tion to a third-party creates an issue with regard to hipaa compliance.48 as the foregoing discussion illustrates, intercollegiate athletic organizations consti­ tute "covered entities" under hip aa when they engage in non-traditional oper­ ations and release an athlete's phlto third parties. b. professional athletic community hip aa treats professional sports organizations similarly, with the notable exception that professional sports organizations can never fall under the ferp a exemption.49 these organizations often create their own exemptions through the use of contractual waivers that allow the teams' athletic trainers to release phi to management, owners, and coaches. so the release of information within the organization constitutes a traditional operation. in addition, the con­ tractual waiver often allows the teams to make certain injury information pub­ lic. 51 the release of information to third parties constitutes a non-traditional operation. without the necessary authorization contained within the contractual waiver, hip aa compliance would be an issue for these organizations. 52 as a result, professional athletic organizations constitute covered entities under hip aa when dealing with both traditional and non-traditional operations and the release of phi. 3; "minimum necessary" disclosure hip aa requires covered entities involved in the transmission, processing, or disclosure ofphl to limit disclosures made by the organization to the amount necessary for the purpose they seek to attain. 53 the act identifies this as the "minimum necessary" information requirement 54 the dhhs, through hip aa, provides exceptions whereby covered entities can ignore this require­ ment and provide more than the minimum necessary amount ss moreover, the act allows covered entities to breach this requirement in three specific situa­ tions.s6 first, hip aa allows a release of more than the minimum necessary 47. pitz, supra note ii, at 13. 48. id. 49. see menge, supra note 13, at 469. 50. see id. (citing nat'l basketball ass'n, nba couective bargaining agreement (2005). art. xxii.§ 3(a)-(c) [hereinafter nba-cba]). 51. see id. 52. see sullivan, supra note 34, at i4. 53. morantz,supra note i4, at482 (citing45 c.f.r. § 164.502(bxi)(2002)). 54. id. (citing45 c.f.r. § i64.502(bxi)). 55. id. (citing 45 c.f.r. § i64.502(bxl)). 56. seeid. 2009] an athlete's right to privacy 55 amount of phi to health care providers providing treatment for a patient. 57 second, a covered entity may release more than the minimum necessary amount when an individual requests his or her own phi. 58 lastly, such a disclosure is permissible when the individual authorizes the disclosure. 59 generally, sports organizations operate under the second and third excep­ tions to the release of the minimum necessary amount ofphi. an athletic or­ ganization may release more than the minimum necessary amount to the athlete who is the subject of the phi.60 additionally, an athlete-through the use of proper authorization formsmay authorize the organization to disseminate more than the minimum necessary amount of phi to individuals within the or­ ganization as well as to outside third parties.61 4. the role of authorization one way to circumvent the hip aa regulations is to obtain an authoriza­ tion form. 62 to get around these regulations and to be able to disclose informa­ tion to a third party, covered entities must obtain written acknowledgement from the injured player by using an authorization form that permits disclosures to exceed the "minimum necessary" requirement.63 the authorization form used by a particular organization must contain certain key elements and must not be a generic blanket authorization. 64 any compliance program seeking to address the intent ofhip aa will fail if it does not contain all of these elements within the contents of its authorization form. 65 various websites contain examples ofbasic authorization forms. 66 organ­ izations must look to state law to determine whether additional measures, beyond hip aa, are required to protect an individual's phi. 67 even if an or­ ganization has obtained an effective authorization form, an individual may re­ voke that authorization in writing at anytime. 68 further, players do not have to sign these authorization forms; treatment, payment, enrollment, or eligibility for benefits may not be conditioned on obtaining the authorization.69 to ensure compliance with hip aa, covered entities must obtain an authorization that in­ cludes: (a) identification of the party authorizing disclosure, (b) a description of the phi authorized for disclosure, (c) identification of the party(s) authorized to 57. id. (citing 45 c.f.r. § 164.502(bx2xi)-(iii)). 58. id. 59. morantz,supranote 14,at482. 60. seeid. 61. seeid. 62. see sullivan, supra note 34, at 14. 63. pitz, supra note 11, at note 3. 64. sullivan, supra note 34, at 14. 65. pitz, supra note 11, at 13. 66. /d. (citing 45 c.f.r. subpart b § 160.201-205). 67. id. 68. id. 69. id. at note 3. 56 indiana health law review [vol. 6:47 make use of the disclosures, (d) identification of the party(s) authorized tore­ ceive the disclosures, (e) a description of the exact purpose for disclosure, (f) a listed date or event causing the authorization to expire, and (g) the date in which the individual signed the authorization.70 a. identification of the party authorizing disclosure one of the core requirements of a hip aa-compliant authorization form is the signature and identity of the person authorizing disclosure of his or her phi.71 nothing within the act requires the document to be notarized or wit­ nessed, and a personal representative appointed to make health-related deci­ sions for the individual may sign the document in the individual's place. 72 hip aa further requires the authorization document to contain a description of the personal representative's authority to act if the representative has signed the document for the individual. 73 in relation to the sports industry, the authoriza­ tion form must clearly identify the athlete and must be signed by the athlete or the athlete's personal representative.74 b. a description of the protected health information authorized for dis­ closure another core requirement of the hip aa-compliant authorization form is a specific and meaningful description of the phi authorized for use and disclo­ sure. 75 hip aa does not require the information to be specifically named; how­ ever, it must be named in such a way as to apprise the individual of the information authorized for disclosure. 76 c. identification of the party(s) authorized to make use of the disclosures another core requirement of the form is the identity of the individual or group authorized to use or disclose the phi.77 hip aa does not require an au­ thorization form to name the specific person or entity authorized to make use of the disclosures, but instead, allows an individual to authorize disclosure to 70. sullivan,supranote34,at 14-18. 71. id. at 14. 72. id. 73. id. 74. seeid. 75. id. at 15. 76. sullivan. supra note 34, at 15 (noting tbat an authorization allowing a covered entity to disclose an "entire medical record" or "complete patient file" remains valid; however, an authorization allowing disclosure of"all protected health information" fails for lack of specifici­ ty). 77. id. at 16. 2009] an athlete's right to privacy 57 classes or categories of individuals or groups. 78 d identification of the party(s) authorized to receive the disclosures hip aa grants the individual authorizing disclosure of phi the right to know the recipients of that information, and the authorization form must desig­ nate the person or entity in which the covered entity plans to release informa­ tion. 79 instead of naming a particular person, the authorization form may designate a specific group of persons to whom the covered entity plans to dis­ close the information. 80 e. a description of the exact purpose for disclosure hip aa requires an authorization form to provide a detailed description regarding each purpose for use and disclosure. 81 for example, "for use during the term of athlete's contract authorizing the release of athlete's injury informa­ tion related to athlete's participation in the sport," is an acceptable description. f. a listed date or event causing the authorization to expire to be hipaa-compliant, an authorization form must designate either a date or an event that causes the authorization to expire. 82 the date or event must bear some relation to the individual or purpose of the authorized use of pid. 83 the authorization form remains valid until the designated expiration date, absent a written revocation by the individual. 84 g. the date in which the individual signed the authorization in addition to a signature by the individual, hip aa requires the authoriza­ tion form to contain the date that the form was signed. 85 unless the authoriza-· tion form expressly limits specific information, it authorizes a covered entity to disclose the identified information regardless of when the information was created.86 78. ld. (noting tbat an authorization form may satisfactorily authorize disclosure with a document that authorizes disclosures "by any health plan, physician. health care professional, hospital, clinic, laboratory,· pharmacy, medical facility, or other healthcare provider that has provided payment, treatment, or services to me or on my behalf' or an authorization form tbat simply authorizes disclosure "by all medical sourcesj. 79. id. 80. id. 81. /d. at 18. 82. sullivan, supra note 34, at 18. 83. /d. 84. /d. 85. id. 86. /d. 58 indiana health law review [vol. 6:47 ill. interests at play in. order to participate at the highest performance level and provide the services expected of professional or collegiate athletes, an athlete's health is of paramount importance. 87 as a result, athletic organizations and sports teams often require their players to undergo certain tests and performance evaluations to assure that the players will be physically able to perform at the highest attain­ able level. 88 all too often, players succumb to injuries while enduring a lengthy season or participating in a weekly practice. who should have a right to the results of these different tests, performance evaluations, and injury reports? in ascertaining an answer to this question, the importance of an individual's inter­ est in protecting their phi must be weighed against the interests of the athletic organizations, the media, and the public. a . . the athlete's interest in phi confidentiality this section assesses an athlete's interest in keeping their phi confiden­ tial, which represents the key purpose and goal of hip aa. 89 the act seeks to protect the most personal information and requires extreme confidentiality.90 the protection of this infonnation represents a strong interest of a traditional athlete. infonnation about a particular injury may be potentially embarrassing or something an athlete simply just does not want shared with the world. fur­ ther, in todais world of multi-million dollar contracts and lucrative free-agent dealings, athletes may want to minimize infonnation that could decrease their overall free-agent or trade value to an organization. in march 2006, grady jackson, an nfl football player, tested the free­ agent market as an unrestricted :free-agent 91 jackson sought a new contract for the 2006 nfl season, and the atlanta falcons invited him to the organization's facilities for a visit.92 jackson spent part of the time at the falcons' facilities undergoing various medical examinations and tests as part of a physical. 93 af­ ter one of the examining physicians recommended that jackson be tested by a cardiologist, the falcons notified jackson and his agent that they wanted further testing on jackson's heart before a decision would be made about any potential contract. 94 the team gave jackson no indication concerning whether or not he had failed his physical examination. 95 87. menge, supra note 13,at469. 88. id. 89. see pitz, supra note 11, at 12. 90. seeid. 91. brief for plaintiff at 2, jackson v. atlanta falcons football club, llc, (n.d. ga. 2007), (no. 07-cv-0939-ge1) [hereinafter jackson briet]. 92. ld. 93. ld. 94. ld. 95. ld. 2009] an athlete's right to privacy 59 two days after jackson's examination at the falcons' facilities, a member of the falcons' organization allegedly told a reporter for a prominent sports me­ dia network that jackson did not pass his physical examination. 96 further has­ tening the problem, a falcons' personnel member also allegedly released additional phi concerning jackson.97 this initial report lead to the information being publicly reported by other prominent media networks, the national press, and numerous other outlets. 98 all of the press reports contained phi regarding jackson's alleged heart problem.99 jackson alleged that the reports caused him and his wife great concern for his health and negatively impacted any interest other nfl teams had in signing jackson.100 jackson noted that other nfl teams questioned him about the al­ leged heart condition during his visits with them. 101 additionally, two teams subjected jackson to a series of extensive cardiology examinations.102 five months after his first visit with the falcons, jackson opened negotiations and signed a contract with the team. 103 following the 2006 season, jackson sued the falcons' franchise for invasion of privacy and defamation over the alleged release of his phi. 104 this situation demonstrates why an athlete would want to protect the con­ fidentiality of their phi. regardless of how the media obtained the informa­ tion, it had a substantial impact upon the free-agent deal jackson eventually obtained. the falcons succeeded in hiring jackson for far less than the 6.8 mil­ lion dollars paid to a top five defensive tackle. 105 players should be able to authorize organizations to disclose information by waiving their hip aa rights, but there should be a distinction between sports-related and non-sports-related injuries or conditions. arguably, a greater interest exists in protecting the non-sports-related injuries and conditions. as in jackson's case, this includes those injuries or conditions that occurred outside the realm of the sport in which the athlete participates. it should be up to the player to decide whether to make information unrelated to his participation in the sport publicly available, since such information has the potential to embar­ rass the player and possibly impact the player's free-agent value. in contrast, there is arguably a shared interest in obtaining sports-related injury information between the player, organization, and media. 96. id. at3. 97. jackson brief, supra note 91, at 3. 98. id. 99. id. 100. !d. 101. id. 102. id. 103. jackson brief, supra note 91, at 3. 104. jackson files suit against fa/cons, disgruntled tackle: unusual for a player under contract, jackson sues team, says medical records wrongly released, atlantaj.-const., mar. 28, 2007. 105. !d. (stating that jackson signed a three year contract with a $300,000 signing bonus, and the falcons paid him the league veteran minimum salary for the 2006 season). 60 indiana health law review [vol. 6:47 b. the organization's interest in running a business and providing infor­ mation to the media and the public athletic organizations have an interest in releasing an athlete's informa­ tion to the media and the public. the sports industry is a multi-billion dollar industry, and the organizations that comprise it have a responsibility to keep their fans informed for a number of reasons. the question remains as to wheth­ er an organization's interest in running a business and providing information to the media and public sufficiently outweighs the player's interest in protecting his or her phi. while an organization's interest does not outweigh the player's interest regarding non-sports-related injuries, it arguably does with injuries that result from participation in the sport. the growing sense of community created by sports teams and the use of stadiums funded largely by the public controls this conclusion. 1. a sense of community to assure that all of the seats in the stadium are full when the first whistle blows, it is important for professional sports organizations to develop a good relationship with the community. teams organize several events year-round to gain support and create the sensation that the team belongs to the community. one example of community building occurred in the city of arlington, texas, home of the new dallas cowboys' stadium.106 when the first two arches supporting the retractable roof on the new stadium were completed, members of the arlington city council, the town's mayor, and other city offi­ cials joined the owner of the cowboys to commemorate the event.107 the mayor told the news media that the city and the organization planned to cele­ brate several more milestones along the way.108 a number of teams also build rapport with the community by utilizing the star-power of their players and cheerleaders to participate in autograph signings, charitable events, and pep rallies. after all of this effort and attention to make the community feel as though they own the team, keeping the public in the dark about the status of certain players may diminish some of that support. organizations and teams could ar­ gue that they have a vested interest in keeping the fans and the media happy to effectively and efficiently run a business. taking away the sports industry's ability to release injury information to the public could diminish the sense of community created by the team or organization, which could lead to a decrease in attendance and merchandise sales. without fan attendance, merchandise 106. another milestone in the new cowboys stadium is reached, http://www.arlingtontx. gov/cowboys/index.html (last visited feb. 11, 2008) [hereinafter cowboy's milestone]. 107. !d. 108. !d. 2009] an athlete's rigiit to prlv acy 61 sales, or the media to create hype for the games, the sports industry would argu­ ably cease to exist. 2. taxing the public to build a new stadium or relocate in today' s sports world, teams often garner funding from taxes and other sources of publicly funded revenue to build new stadiums or relocate to a new city.109 this adds to the sense that teams are a part of the community and that they owe it to the community and the fans to inform them of the injury status of their favorite players. the amount of money traditionally given to a team from the public to build a new stadium or relocate to a new city varies on a case-by­ case basis. for example, the arizona cardinals recently built a new stadium with an overall cost of approximately $455 million.110 the arizona sports and tourism authority contributed over $300.4 million to the cost of the stadium, and the team fronted the rest of the cost of construction.111 in addition to the overall funding costs, the stadium project sought to provide added economic benefits to the area. 112 in texas, the dallas cowboys recently completed negotiations for the funding of a stadium that will house the team in 2009.113 under the terms of the original funding and closing agreement between the dallas cowboys and the city of arlington, the organization and the city were to each pay up to half of the total project cost of$650 million.114 further, the organization agreed to pay for any overruns that occurred during construction.115 since the date of the original agreement, the stadium's estimated cost has jumped to one billion dol­ lars; the city and organization expect the stadium to be one of the biggest and best of its kin& 116 the stadium should fulfill the city's expectations of elevat· ing the city's profile and attracting marquee events.117 as a result of the large amount of public funding for these stadiums and other sports venues throughout the united states, the public feels entitled to all 109. seeid. 110. university of phoenix stadium-statistics, http://www.universityofpboenixstadium. com/index.php?page=stadium_fucts&section=statistics (last visited feb. 11, 2008). ill. id. 112. id. (noting that the stadium's construction phase increased the area's economic benefit by $400 million and added 3,500 jobs. $20 million will be given to the arizona state general fund throughout the construction period. further, the team contributes approximately $150 million to the area's yearly economic output). 113. cowboy's milestone, supra note 106. 114. ld. 115. seeid. 116. michael granbeny, new stadium mzy w"ufen social divisi011s: cowboys officials say venue will offer fun for all fans, but some a.ren 't so sure, thi!dailasmorning news, dec. 10, 2006, available at http:/lwww.dallasnews.com/sban:dcontent/dwslnewsllocalnews/cowboys stadiumlstories/l21006dnmetgenerations.32et3c£htm1. 117. id. 62 indiana health law review [vol. 6:47 of the information about these orgaoizations.118 this feeling of entitlement ex­ tends to the release of injury information related to an athlete's participation in the sport. to satisfy this feeling of entitlement, teams have an interest in re­ leasing information regarding sports-related-injuries to the media and public. 3. the indianapolis colts over the past few years, someone living in indianapolis would be hard pressed to avoid the "make it personal" or "blue nation" signs, billboards, and radio advertisements throughout the city. the indianapolis colts (the "colts") also sponsor numerous community-building events in the convention center; in stores throughout the city, and on monument circle. other activities include: children's games, free concerts, and autograph signings. the colts moved to indianapolis nearly twenty-four years ago.119 after failed attempts to reach an agreement with the city of baltimore to build a new stadium, then-owner robert lrsay, packed up the team in the middle of the night and moved it to indianapolis.120 irsay recognized the move as the team's only option, after stalled negotiations for a new baltimore stadium.121 on the other end of the move, indianapolis and a new stadium awaited. originally known as the hoosier dome, the total cost of construction for the rca dome was $77.5 million.122 the lilly endowment and the krannert charitable trust contributed $30 million toward the cost of construction, and the city financed the remainder by selling $47.2 million in bonds.123 despite the recent construction of a new stadium to replace the rca dome, indianapo­ lis still owes a principal of approximately $75 million on bonds related to the rca dome's construction.124 the city uses a marion county restaurant tax to 118. see generally update: sports-stadium funding, issues and controversies, aug. 23, 2008, available at http://personal.ecu.edu/aldermandlgeog2019/stadium _ funding_issue.html (indicating that the combination of publicly funded stadiums and a partial government anti-trust exemption given to professional sports leagues elevates the public interest to such a level that even congress may become involved); see also, e.g., lester munson-8pecter's inquiries put nfl's lucrative broadcast structure in play, http://sports.espn.go.comlnfllcolumns/story? col­ umnist=munson_lester&id=3226250 (discussing senator arlen specter's investigation into the nfl's spygate scandal, in which the new england patriots were caught illegally video taping the opposing sidelines defensive signals) (last visited feb. 9, 2009); see also, e.g., espn.com­ leaders ofhouse subcommittee contact mitcheu, http://sports.espn.go.com/mlb/news/ sto­ ry?id=2749552 (discussing congressional involvement in the investigation of steroid use in baseball) (last visited feb. 9, 2009). 119. jmett bell, as colts return to baltimore, owner /rsay says leave the past behind, usa today, jan. 11,2007, available at http:/lwww.usatoday.comlsportslfootballlnfllcolts/2007 -01-1 0-baltimore x.htm. 120. /d. 121. /d. 122. city still owes $75 million on soon-to-be demolished rca dome, south bend tribune, oct. 29, 2006, available at http:/lblogs.then.ewstribune.comlindex.php/all/2008/02. 123. /d. 124. /d. (noting that the city intended forthercadometo be paid offby2013; however, several refinancing measures and term extensions moved the payoff date to 2021, which is thir2009] an athlete's right to privacy 63 raise a portion of the money used to pay those bonds.125 despite still owing on bonds attributed to the rca dome, the city of in­ dianapolis entered into an agreement with the colts to build the new lucas oil stadium.126 the stadium will act as the new home of the colts, house national collegiate athletic association ("ncaa") men's and women's basketball events, and be utilized for major conventions.127 the estimated stadium cost of around $700 million is being funded by a joint fundraising venture by the state of indiana and the city of indianapolis, with the colts organization providing $100 million.128 marion county, in order to provide for its share of the stadium costs, raised taxes on food and beverage, auto excise, inn keeping, and admis­ sion.129 a one-percent increase in food and beverage taxes in six counties sur­ rounding marion county and the sale oflicense plates bearing the colts' logo completes the total. 130 the city anticipates reaping a number of economic bene­ fits from the new stadium.131 as a result of the sense of community created by the colts organization and the significant amount of public funds used to fund both the rca dome and lucas oil stadium, the organization retains a significant interest in main­ taining the public's support. because the stadiums were both heavily funded using public money, the fans arguably have a right to know much of the infor­ mation relating to the team. the colts organization also has an interest in pro­ viding that information. the question remains as to whether the organization's interest in running a business and maintaining public support outweighs the individual athlete's interest in protecting his pill. while the organization's in­ terest does not outweigh the player's interest regarding non-sports-related inju­ ries, it arguably does regarding injuries that result from participation in the sport. the growing sense of community created by the colts organization and by the publicly funded stadiums supports this conclusion. in 2006, an injury by one of the colt's players, corey simon, provided an illuminating example of these competing interests at work. on october 5, 2006, the colts placed simon, a defensive tackle, on the nfl's non-football injury list.132 although simon had not practiced since injuring his knee during training camp in august 2006 and subsequently undergoing arthroscopic surteen years after the city and organization tore down the rca dome and moved into lucas oil stadium). 125. ld. 126. ld. 127. lucas oil stadium fact sheet, in.oov, available athttp://www.ingov/iscba/2371. htm. 128. ld. 129. jd. 130. jd. 131. i d. (noting that the new stadium will keep the colts in indianapolis with a new long­ term contract, create room to expand the city's convention center, provide $2.25 billion in eco­ nomic benefits to the area, and lead to the creation of 4,200 new permanent jobs and 4,900 tem­ porary construction jobs). 132. tom james, colts' corey simon out for season, trmune star, oct. 6, 2006 availa­ ble at bttp:llwww.tribstar.com/sports/local_ story_ 279001 022.html. 64 indiana health law review [vol. 6:47 gery, the colts organization noted in a prepared statement that simon's inactivi­ ty did not relate to the game of football. 133 colts' team president, bill polian, issued a statement noting that "[i]n deference to corey's privacy and in com­ pliance with federal medical privacy laws, we may not discuss the particulars of corey's condition other than say it is an illness [and] not an injury and is unre­ lated to the knee surgery he had in august. it is not football-related. "134 any further information provided by the organization remained ambiguous, and the organization offered no insight into the nature of the illness or possible treat­ ment options.135 the lack of information released by the team regarding simon led to a wide range of speculative thoughts on the part of fans and the media, creating a mystery injury or illness. a number of fans expressed anger and confusion over . why the organization insisted on keeping them in the dark about one of the team's veteran players. one fan even went so far as to paint a big red ''x" on his corey simon jersey and tape it to the front of the bus he and his friends used for tailgating. media outlets ran reports speculating that simon had poly.· arthritis; however, despite all of this, the colts organization would not release information relating to the team-designated non-football injury. despite the anger, confusion, and speculation it created, the colts organi­ . zation handled the matter both professionally and legally. the organization stayed within the purviews of the nfl 's collective bargaining agreement and settlement agreement by respecting simon's privacy and complying with the federal medical privacy laws. ultimately, however, the action taken by the colts organization in not releasing simon's injury information supports the conclitsion that teams should be able to release information about injuries that are related to the sport. no one contests that organi7lltions should not be able to release information about non-sport's related injuries, as the player's interest in protecting their phi regarding injuries unrelated to participation in the sport outweighs the interests of the organization in satiating the public's appetite for such information. if simon's inactivity resulted from the knee injury he suf­ fered during training camp, the injury is related to his participation in the sport and the public's sense of entitlement to the injury information would arguably be greater. 4. the green bay packers in discussing the sense of community created by professional sports or­ ganizations seeking to maximize revenue and fill seats, the green bay packers organization is in a unique situation. owned by the city of green bay and the green bay and brown county professional football stadium district, 136 the 133. /d. 134. /d. 135. /d. 136. lambeau field-stadium info, http:lwww.lambeaufield.com/stadium._infolhistory 2009] an a1hlete's right to privacy 65 packers organization faces the biggest challenge in dealing with the release of player information to the fans and the media, as there exists a large public sense of entitlement to that information. the tradition of lambeau field, the packers' stadium, began with the opening kickoff in 1957 and continues to this day.137 the ownership structure of the team, along with the often cold and hostile weather conditions, has fos­ tered the growth of that tradition throughout the years.138 games such as the infamous ice bowl, played between the packers and the dallas cowboys on december 31, ·1966, add to the rich history that has led to lambeau field being coined as the frozen tundra.139 lambeau field, with an active tenure of fifty years, sits at the top of the list of the longest continually occupied nfl sta­ diums and registers a respectable third on the list for the longest home field te­ nures in all professional sports.140 adding to the organization • s interest in sharing information with the media and the fans, the packers have managed to successfully sell out on a season ticket basis since 1960 and continue to accu­ mulate names for the ticket waiting list every season.141 the packers organiza­ tion authorizes season ticket holders to transfer their season tickets to qualifying heirs and transferees upoil notarized authorization on an official transfer form.t42 as a result of the traditions surrounding the organization and the sense of community created by city ownership, the packers' interest in running a busi­ ness and providing information to the media and public arguably outweighs the players' interest in protecting their phi. that business interest, however, only goes so far and should only extend to phi that relates to the athlete's participa­ tion in the sport. information relating to non-sports related injuries should re­ main private, as an athlete's interest in protecting that information outweighs any interest of the organization because it does not directly relate to the ath­ lete's participation in the sport. (last visited feb. 11, 2008) [hereinafter lf. stadium info]. 137. /d. 138. /d. 139. pro football history-the ice bowl, http://www.profootballho£comlhistory/decades/ 1960s/ice_bowl.jsp (noting that 50,000 fans braved the elements for the ice bowl despite the game time temperature registering thirteen degrees below zero) (last visited feb. 11 2008). see also nfl championship game, 1967, http://en.wikipedia.org/wiki/nfl_championship_ game,_1967 (last visited feb. 11, 2008). the game's officials stopped using their whistles fol­ lowing the opening kickoff after the referee who blew his metal whistle to signal the start of the game had his whistle freeze to his lips. the officials utilized voice commands to officiate the rest of the game. /d. 140. l.f. stadium info, supra note 136. the boston red sox have occupied fenway park for ninety-five years, and the chicago cubs organization has made wrigley field its home for ninety-three years. id 141. lambeau field-events info, http:lwww.iambeaufield.com/events_infolpackers _game_ tickets (last visited feb. 11, 2008). 142. see id. for the exact language of the official policy on transfer of packers season tickets. 66 indiana health law review [vol. 6:47 c. the public's interest in obtaining information and knowledge about individuals who have placed themselves in the public eye this section discusses whether or not an athlete's decision to play sports at a collegiate or professional level should constitute a waiver of his or her pri­ vacy rights, making his or her pm a matter of public concern. the sense of community created by sports organizations and the growing trend toward pub­ licly funded stadiums add to the sense of public entitlement to an athlete's in­ jury information. in addition, the question arises as to whether an athlete's participation in a sport places the athlete in the public eye and causes any in­ formation about that athlete to become a matter of public concern. this re­ quires a balancing of the player's interest in keeping pm private with the public's interest in staying apprised of information about a public figure. while the public's interest does not outweigh the player's interest regard­ ing non-sports-related injuries, the same conclusion is not as clear regarding the public's interest in information about injuries that result from participation in the sport. the growing sense of community created by sports teams, the use of stadiums funded largely by the public, and the public's interest in staying ap­ prised with information relating to a public figure all complicate this inquiry. a person or entity releasing information about another's private life avoids liability to the other for invasion of privacy if the information would not be overly offensive to a reasonable person and is a matter of legitimate public concern.143 generally, an individual's right to privacy is secondary to the pub­ lic interest in obtaining information of public concern, and; in today's society, actions taken by public figures become matters oflegitimate public concern.144 subsequently, when the media reports on information about a collegiate or professional athlete's phi, the athlete has no available tort action against the media, unless the information reported was knowingly false. 145 additionally, the media does not constitute a covered entity under mp aa and would not be liable for the release of information.146 sports organizations, however, do con­ stitute as covered entities under mpaa, and athletes would arguably have an action in tort against a sports organization for the unauthorized release of a player's pm. because injury information pertaining to an athlete's participation in the sport is arguably a legitimate public concern, sports organizations should be able to release that information with proper authorization. 147 injury information not pertaining to an athlete's participation in the sport, however, should be pro­ tected because it is potentially offensive and private information that should not 143. restatement(second)oftorts § 6520 (1976). 144. sidis v. f-rpubl'g corp., 113 f.2d 806(2d cir. 1940). 145. seeid. 146. see pitz, supra note 11, at 12. 147. see restatement(second)oftorts § 6520(1976). 2009] an ann.ete's right to privacy 67 be released to third parties. 148 iv. an atiempt at compliance: organizational models while an athlete's injuries, both on and off the field, often raise questions related to medical information privacy, it appears that professional and colle­ giate athletes have agreed to be subject to a different standard of privacy.149 the following section explains the role and use of different organizational models and analyzes their effectiveness in complying with hip aa. a. national basketball association collective bargaining agreement the national basketball association ("nba") represents one industry dominated largely by collective bargaining.150 policies found within the nba's collective bargaining agreement ("cba'') arise from negotiations between the nba and the national basketball player's association ("nbpa''). many of the policies applied to the league's players come as aresultofthe league'scba.151 a player cannot contest or challenge these policies.152 while, on its face, hip aa may appear to pose a problem for the nba in releasing a player's in­ jury information to the media or the public without the player's consent, the nba' s cba acts as a contractual waiver of the player's hip aa rights--at least with regard to release by the team's management 153 as a result, the cba gives teams and organizations the authorization to acquire any information regarding a player's past or present medical condi­ tion.154 this includes a player's past medical history and current health prob­ lems.155 the cba authorizes a team physician to "disclose all relevant medical information concerning a player to (i) the general manager, coaches, and train­ ers of the team ... " and to "(ii) any entity from which any such team seeks to procure, or has procured, an insurance policy covering such player's life or any disability, injury, or illness."156 in addition to the disclosure of information within the confines of the team, the cba also permits trainers, team officials, and athletic organizations to make such information public.157 the information released to the public, however, must be in relation to the "reasons why any such player has not been or is not rendering services as a player."158 essential148. see id. 149. menge, supra note 13, at 469. 150. id. 151. ld. 152. id. 153. id. (citing nba-cba, supra note 50). 154. id. (citingnba-cba,supranote50). 155. menge, supra note 13, at 469 (citing nba-cba, supra note 50). 156. id. (internal quotations omitted). 157. id. 158. id. (internal quotations omitted). 68 indiana health law review [vol. 6:47 ly, this provides teams with the authority to circumvent the hip aa guidelines and release injury reports. moreover, as a result of the cba, teams in the nba may release information to the public that explains why a player will not be playing in a particular game or information regarding the specific medical rea­ sons for the organization's termination of a player.159 b. national football league collective bargaining agreement prior to the implementation of hip aa, individuals speculated as to how the nfl would react to the final regulations.160 the nfl had three options.161 first, it could challenge the act's constitutionality.162 second, the league could ob~ the law and stop releasing injury reports.163 third, the league and nfl players association could include a provision in the collective bargaining agreement that authorizes the release of injury infomiation.164 after hip aa was enacted, the nfl made no attempt to challenge the constitutionality of the act, and it continues to release injury reports every week during the season. in addition, the league's cba does not contain an authori­ zation for the release ofphi.165 it is possible that this information is contained within the stipulation and settlement agreement incorporated within the cba; however, the .nfl does not make that agreement public.166 the league's approach to the release of injury information is best analyzed by considering the approaches that individual teams take. the approach taken by the kansas city chiefs in dealing with larry johnson's injury and by the indianapolis colts in dealing with corey simon's injury, while representing different approaches, provide insight into the league's approach. with john­ son, the chiefs refused to release information related to johnson's injury and cited hip aa privacy laws despite the injury being related to his participation in the sport.167 the nfl, however, does not customarily cite hip aa in regards to on-field injuries.168 typically, teams in the nfl take the approach used by the colts in dealing with simon-limited disclosure to the degree it pertains to an athlete's participation in the sport.169 159. id. 160. new law could hamstring nfl on injury reports, 1he san diego union-tribune. june 16, 2002, available at http://www.fo1ey.com/publications/pub _ etail.aspx?pubid= 1260. 161. id. 162. id. 163. id. 164. id. 165. nat'l football league, nfl collective bargaining agreement between the nfl management council and the nfl players association, (2006), http://www.nflplayers.cornl images/fck/nflcoilectivebargainingagreement2006-2012.pdf[hereinafter nfl­ cba] (last visited feb. 11, 2008). 166. id. 167. covitz, supra note 2. 168. id. 169. james, supra note 132. 2009] an athlete's right to privacy 69 the fact that the nfl even allows teams to place players on a non­ football-injury list, a list that does not require the team to report the specific nature of the injury, suggests that teams are not authorized to release informa­ tion about injuries unrelated to a player's participation in the sport. further, the nfl's standard practice is to release information relating to a player's partici­ pation in the sport and refuse to release information unrelated to that participa­ tion.170 c. national collegiate athletic association this section discusses the use of authorization forms for collegiate ath­ letes in order to facilitate compliance with hip aa in regards to the non­ traditional operations of an intercollegiate athletic organization. in particular, this section introduces and breaks down two different types of authorization forms and methods. 1. butler university sports medicine standard authorization form butler university,located in indianapolis, indiana, participates in ncaa division i athletics.171 to comply with hipaa regulations, the university's sports medicine program requires intercollegiate athletes to sign a consent form when disclosing information to third parties. 172 as noted before, hip aa only requires intercollegiate institutions to obtain authorization for the release of in­ formation relating to non-traditional university operations because the act ex­ empts traditional university operations. 173 butler's authorization form requires identification of the athlete and the person or persons authorized to release phi. 174 in addition, the form asks the athlete to name the specific information that may be released and to whom. 175 the authorization form states the purpose of the authorized disclosures by not­ ing that "(a]ttendance and progress will be reported to the above on a weekly basis or as specified below,'' clearly stating the purpose of the disclosure.176 the form requires the athlete's dated signature and also notes that the authori­ zation expires sixty days after being signed. 177 the document meets each core 170. seeid. 171. butler university sports, http://butlersports.cstv.comlindex-main.html (last visited jan.29, 2009). 172. butler university sports medicine-consent to release information, http:/lbutler sports.cstv.comlauto _pdi7p _hotos/s _ cboolslbutl/genrel/auto _pdf7sportsmedrelease [hereinafter butler consent] (last visited feb. 11, 2008). 173. see pitz, supra note 11, at 13. 174. butler consent, supra note 172. 175. /d. 176. /d. 177. /d. 70 indiana heal1h law review [vol. 6:47 requirement of a hip aa-compliant authorization form. 178 2. notice plus informed consent model the notice plus informed consent model represents another model that sports organizations could implement to ensure compliance with hip aa regu­ lations.179 this model suggests that intercollegiate or professional sports organ­ izations provide a notice to student athletes to inform them that information relating to their participation in the sport would be released.180 following the notice, the sports organization would present an informed consent document for the athlete to sign.181 the informed consent document would specifically au­ thorize the release of the requested information.182 such a model would likely comply with the requirements ofhip aa. be­ cause the notice and informed consent models both request the disclosure of specific information, neither would be considered blanket authorizations.183 organizations would simply have to assure that the documents include other required information, such as the athlete's name and dated signature, the pur­ pose for the agreement, an expiration date, and information on the persons or entities authorized to use and receive the information.184 d. national athletic trainers' association around august 2003, the national athletic trainers' association (''nata") suggested that athletic trainers working for sports organizations and colleges require athletes to sign authorization forms prior to every event in which the athlete could potentially be injured and that the injury information should somehow be disclosed to the media.185 the recommendation arose out of the fear that an authorization form covering more than one event would be considered a blanket authorization and would not be hip aa-compliant 186 this fear, however, arises from confusion over what exactly constitutes a blan­ ket authorization. a blanket authorization is an authorization form that remains generic in nature and lacks specificity.187 for example, an authorization form releasing all protected health information would be considered a blanket authorization and 178. see sullivan, supra note 34. 179. see pitz, supra note 11, at 12-13. 180. /d. at 13. 181. id. 182. ld. 183. see sullivan, supra note 34, at 14. 184. seeid. 185. pitz, supra note 11, at 13. 186. ld. 187. see sullivan, supra note 34, at 14. 2009] an athlete's rigiit to privacy 71 would not be deemed hipaa-compliant188 moreover, hipaa does notre­ quire athletic trainers and sports organizations to require athletes to sign autho­ rization forms before every game.189 as long as the authorization fonn specifically indicates which information is to be released, the party authorized to release the information, the party authorized to receive the information, and contains the other required information (i.e. name, purpose, signature date, and expiration), it will comply with hip aa guidelines.190 v. public policy rationale this section discusses the competing public policy rationales driving the debate over whether to allow the release of injury information relating to an athlete's participation in a sport through the use of appropriate authorization forms. a. the promotion of betting lines and gambling one argument against releasing injury reports is that individuals may easi­ ly utilize these reports to create betting lines or to gamble on college or profes­ sional sports.191 sports betting is a popular fonn of gambling that generates billions of dollars annually.192 in the united states, nevada remains the only state to allow sports betting; however, the boom of internet gambling sites creates an alternative vehicle for sports gambling.193 these sites offer sports gamblers the opportunity to place a bet with a company located in a country that legally permits such betting.194 supporters of legalized gambling classify it as a hannless diversion and argue that people should be able to do what they please with their earned in­ come.195 proponents also argue that legalized gambling generates economic benefits, such as investment opportunities and jobs, tax revenue to the sur­ rounding community, and increased tourism.196 opponents oflegalized gambling often focus on the various social ills that gambling arguably fosters.197 gambling is a compulsive habit that dispropor­ tionately affects economically disadvantaged individuals and may lead to an 188. see id. 189. seeid. 190. seeid. 191. pitz, supra note 11, at 13. 192. william n. thompson, gambling, microsoft bncarta online encyclopedia (2008), available at http://encarta.msn.com/text_761560772_0/gambling.html (hereinafter sports betting]. 193. ld. 194. ld 195. ld 196. /d. 197. id 72 indiana health law review [vol. 6:47 increase in crime and the corruption of political and law enforcement offi­ cials.198 in addition, gambling could increase the potential of fixed or illegally influenced sporting events. 199 as it relates to this note, the relevant inquiry is whether the release of in­ jury reports supports the creation of betting lines and gambling on individual sporting events. a simple search of one internet gambling site reveals informa­ tion pertaining to a team's injuries, recent transactions, offensive and defensive statistics in comparison to the rest of the league, and the results of the team's previous games. 200 the overwhelming amount of non-injury information avail­ able and the significant number of other factors that go into the creation ofbet­ ting lines suggests that it is unlikely that stopping teams from releasing injury reports would lead to a dramatic decrease in gambling. these considerations­ in addition to a sports organization's interest in running a business and satiating the media and the public, along with the public's interest in obtaining informa­ tion relating to an athlete in the public eye-may override public policy con­ cerns related to the release of injury reports. b. contractual waiver of protected health information a second public policy inquiry is whether a player should be allowed to waive or contract away their hip aa rights with a contractual waiver. the cen­ tral issue is the enforceability of such a contractual waiver, which gives rise to the question of whether a contract between a sports organization and an athlete contracts away too much information with regard to the athlete. courts have often held contracts dealing with information and issues overly personal to the parties unenforceable, noting that the legal system does not want to entangle itself with such personal decisions.201 in addition, the contractual waivers used by professional sports organiza­ tions often fail to include a specific expiration date, which calls into question the validity of the authorization form.202 furthermore, this section also analyzes the substance and form of such waivers. 1. non-sports-related injuries the dhhs initially enacted hip aa in an effort to shield the past, present, and future physical or mental health conditions of an individual from 198. sports betting, supra note 192. 199. !d. 200. bodogncaa college basketball butler, http://www.bodoglife.com/betting­ teams/ncaa-college-basketbalv46 (last visited feb. 11, 2008). 201. see, e.g., 7 richard a. lord, wll..liston on contracts § 16 (4th ed. 2008)( discuss­ ing bargains tending toward unenforceability as a result of their personal nature, including sur­ rogacy agreements, agreements dealing with religion, and bargains in restraint of marriage). 202. see nba-cba, supra note 50; see also nfl-cba, supra note 165. 2009] an allilete's right to privacy 73 unauthorized disclosure to third parties.203 as a result. hip aa pertains to inju~ ries that are both related and unrelated to an athlete's participation in a particu~ lar sport. in dealing with the contractual waiver of such personal information, one must analyze whether the information is too personal to the individual for the contract to be enforceable. arguably, an athlete holds a greater interest in protecting information not related to participation in the sport, and a contract waiving the release of such information should be deemed too personal and unenforceable. the fact that an injury occurs outside of the scope of an athlete's participation in the sport deva~ lues the sense of entitlement attributed to the sports organization's interest in running a business and the public's interest in gaining access to information of public concern. it gives greater weight to the athlete's interest in keeping their phi private. as a result. a contract authorizing an athletic organization tore~ lease information unrelated to an athlete's participation in the sport should be held void as against public policy. 2. sports~related injuries a different analysis is required when addressing injuries related to an ath~ lete's participation in the sport. arguably, the information is of a less personal nature. while this information is still personal in the traditional sense, the fact that the injury occurred within the scope of the athlete's participation in the sport increases the weight that should be given to the sports organization's in~ terest in running a business and the public's interest in gaining access to infor~ mation of public concern. a contractual waiver authorizing the release of such information should be deemed enforceable and courts should not find such a contractual waiver unenforceable for public policy concerns. 3. expiration in order to be hip aa-compliant. an authorization form or contractual waiver must designate either a date or an event that causes the authorization to expire, and the event must bear some relation to the individual or purpose of the authorized use of phi. 204 the cbas implemented by most professional sports leagues often act as an overarching agreement that pertains to all of the leagues' players. 205 such agreements, however, lack specificity regarding the expiration of the agreement in relation to an individual athlete. despite lacking specificity regarding the agreement in relation to an indi~ vidual athlete, two elements of the cba make it sufficiently specific to be hip aa-compliant. first. the agreements between the player's association and 203. pitz. supra note 11, at 12 (citing preamble to the health insurance portability and accountability act ofl996, 65 fed. reg. 250 (dec. 28, 2000)). 204. sullivan, supra note 34, at 18. 205. see menge, supra note 13, at 469. (citing nfl-cba, supra note 165). 74 indiana health law review [vol. 6:47 the respective leagues contain expiration dates of their own.206 since these agreements contain the release of phi, the expiration dates for these agreements constitute the expiration dates for the authorizations. second, the cba of a respective league applies only to players under contract with a team in that league. 207 further, the termination of a player's contract with a particular team could be viewed as an expiration event, which satisfies the expiration require­ ment for a hipaa-compliant authorization form.208 c. blanket authorizations a third public policy argument is whether blanket authorizations should be considered hip aa-compliant. a blanket authorization represents an autho­ rization form that remains generic in nature and lacks specificity.209 for exam­ ple, an authorization form releasing all phi would be considered a blanket authorization and would not be hipaa-compliant.210 such an authorization fails to meet the specificity requirements contained within hip aa and would allow an organization to release any mental or physical health information of an athlete. 211 while an organization should be able to release information relating to the athlete's participation in a particular sport, authorizing an organization to release any information exceeds the confines of valid hipaa authorization. the authorization form must specifically denote the information to be re­ leased, the party authorized to release the information, and the party authorized to receive the information, as well as name, purpose, signature date, and expira­ tion, in order to succeed under the purviews ofhipaa.212 blanket authoriza­ tions remain too general and authorize the release of too much phi. 213 sports organizations, in order to remain hip aa-compliant, should make sure to spe­ cifically connote the information authorized for release within the authorization form or contractual waiver. vi. argument in dealing with an athlete's phi, collegiate and professional sports organi­ zations manage information concerning injuries both related and unrelated to the athlete's .participation in the sport. the question arises as to what injury information, if any at all, these organizations should be able to release to third parties. the importance of an individual's interest in protecting his or her phi 206. see nba-cba, supra note 50; see also nfl-cba, supra note 165. 207. seeid. 208. see sullivan, supra note 34, at 14. 209. seeid. 210. seeid. 211. see id. 212. see id. 213. see id. 2009] an athlete's right to piuv acy 75 must be weighed against the interests of the athletic organizations, the media, and the public at large. a. balancing of interests when considering non-sports-related injuries, the athlete's interest in keeping his or her phi private arguably outweighs the interests of the athletic organizations, the media, and the public at large. injuries unrelated to the par­ ticipation in the sport do not share the same connectivity to the team's commu­ nity building efforts and publicly funded stadiums. in addition, such infonnation is more private because of its greater potential for embarrassment or offense, and because the athlete has not thrust that information into the lime­ light as a result, such infonnation is not an appropriate public concern and should not be released even with proper authorization. using this same balancing test to analyze sports-related injuries, the ath­ lete's interest in keeping his or her phi private arguably succumbs to the inter­ ests of athletic organizations, the media, and the public. injuries related to the participation in the sport are arguably more connected to an organization's community building efforts and publicly funded stadium. in addition, such in­ formation is of more legitimate public concern because of the athlete's choice to thrust themselves into the limelight by playing a collegiate or professional sport. further, a sport's organization has a vested business interest in keeping its fan base content. keeping information about a star player ftom the fans may diminish some of that support. as a result, an organization's interest in running a successful business and the public's interest in staying apprised of an athlete's playing status sufficiently outweighs that athlete's interest in keeping their phi private. b. authorization in addition to only releasing information related to the player's participa­ tion in a sport, sports organizations should make sure to obtain a hip aa­ compliant authorization fonn for the release of information ftom each player.214 each authorization fonn should include: the identity of the athlete, the phi authorized for release, the athlete's signature, and the date.215 the authoriza­ tion fonn should also document the purpose of the release, who can use and distribute the released information, who can receive the released information, and an expiration date. or event 216 everything within the authorization fonn should be stated with specificity to avoid classification as a blanket authoriza­ tion. 217 as long as an authorization fonn includes all of these necessary ele214. see sullivan, supra note 34, at 14. 215. see id. 216. seeid. 217. seeid. 76 indiana heal1h law review [vol. 6:47 ments, it may be a part of the aforementioned standard authorization, the notice plus informed consent authorization, or a collective bargaining agreement c. public policy the public policy considerations associated with the release of ijuury in­ formation are arguably not strong enough to prevent sports organizations from releasing information related to an athlete's participation in the sport. while the release of injury information may contribute to the formulation of betting lines and contribute to sports betting in general, too many other factors contri­ bute to the practice of gambling to validate a public policy ban on the release of injury information. in addition, while gambling has some undeniable negative effects, it is not devoid of benefits, such as economic benefits to government coffers. further, injury information related to participation in the sport is not too personal to contractually waive the release of such information because the in­ jury occurred within the scope of the athlete's participation in the sport. this lends additional legitimacy to the sports organization's interest in running a business and the public's interest in gaining access to information of public concern. d. organizational education beyond ensuring that an athlete's phi relating to their participation in the sport be released only with appropriate authorization, an organization should take the time to educate its employees on hip aa requirements. individuals who handle the information within the organization should be educated on what information can and cannot be released and what information should be in­ cluded within the contents of a hip aa-compliant authorization form. taking the time to educate these individuals would eliminate much of the confusion associated within hip aa compliance in the sports industry. vd. conclusion in the end, sports organizations, with appropriate player authorization, should be permitted to release an athlete's sports-related injury information without being liable for a hip aa violation. such a conclusion is consistent with public policy and follows a longstanding athletic tradition supported by the balancing of the player's interest in keeping their pill private, the organiza­ tion's interest in running a business, and the public's interests in being apprised of information of public concern. negligence, medical malpractice, vicarious liability, or patient responsmility: who should pay when a patient contracts mrsa from a healthcare facility? beth a. barnes • i. introduction ......••............•.•..•..••.....••......•••..•.......•..•......•............ 335 ll. background .......•..............••......•.....•......•.••....•........•..................• 339 a. the history of mrsa ............................................................... 339 b. transmission of mr.sa ......•......•.......•...........................•........... 340 c. mrsa resistant to almost all antibiotics .............................. 341 lli. preventative measures that work and new insurance policies preventing cost -recovery for secondary infections ..................................................................................... 342 a. preventative measures ............................................................. 342 b. medicare/medicaid and private insurance policies forbidding payment of secondary infections ............................................. 345 c. the costs to treat versus the costs to prevent mr.sa ............ 34 7 n. analysis: why facilities should be held liable under claims of negligence. medical malpractice. or vicarious liability ....................................................................................... 348 a. the law in the united states ................................................... 348 1. negligence ......................................................................... 350 2. medical malpractice ......................................................... 355 3. vicarious liability ............................................................. 358 b. recent legislation .................................................................... 360 1. pennsylvania ..................................................................... 360 2. california ................................................................ : ......... 361 3. new jersey ......................................................................... 362 4. illinois ................................................................................ 362 5. tennessee .......................................................................... 362 6. new hampshire, indiana, district of columbia, virginia, and texas ........................................... _ ................................ 363 v. conclusion .................................................................................. 364 i. introduction envision entering the hospital for a common surgical procedure or ill­ ness. while in the hospital you are placed in the same room as a patient who has methicillin-resistant staphylococcus aureus (''mrsa .. ). an antibi• j.d., 2009, indiana university school of lawindianapolis; b.s., 2003, ball state university. 336 indiana health law review [vol. 7:335 otic-resistant infection. during the course of your treatment, physicians and nurses fail to wash their hands between contact with you and your room­ mate. after a few days, you acquire an antibiotic-resistant infection and tests reveal it is mrsa.. what was supposed to be.a short hospital stay has turned into more than three weeks of inpatient care and a lifelong health issue: after discharge from the hospital, you contact an attorney because the hospital wants you to pay for the extended stay. you insist you would not have be~n hospitalized for more than a few days had you not contracted mrsa while in the hospital. a legal situation arises and courts are faced with determining. whether you, your insurance company, or . the hospital must foot the bill for the costs associated with the mrsa infection. your situation. is not ljilique; rather, it is a growing trend in healthcare facilities across the nation. each year in the united states thousands of people enter hospitals, long-term care facilities, and other medical centers (hereinafter, "facilities" or "facility") for treatment of illness or injury. patients do not expect to contract an infection while receiving medical care; yet, in recent years, a growing number of patients have contracted nosocomial infections1 and become more.illthan when they first presented to the facility.2 the centers for disease control and prevention ("cdc") discovered that each year more than two· million healthcarc-acquired infections are · reported,3 which result in over 100,000 deaths.4 the cdc also determined that at least one­ third of healthcare-acquired infection deaths were preventable.5 facilities are· notorious for developing pathogens6 because patients bring infections into the facility then spread these infections to other patients. 7 these infec­ tions often. become drug-resistant when the bacteria mutate and become able to defeat currently used antibiotics.8 the overuse of antibiotics has made bacteria capable of mutating and becoming drug-resistant.9 mrsa is one of these drug-resistant infections and is currently one of the most ram­ pant nosocomial infections in healthcare facilities worldwide.10 1. n~socomial infection refers to an infection acquired in the facility that the patient did. not have prior to admission. trisha torrey, what are nosocomial infections?, http://patients.about.com/odlglossary/glnosocomial.htm (last visited may 7, 2009). 2. david polin, 43 am. jur. proof of facts 2d §109 (2008); betsy mccaughey, unnecessary deaths: the human and financial costs of hospital infections 1 (committee to reduce infection deaths, 3rd ed. 2008), available at http:// www.hospitalinfection.org/ridbooldet.pdt: 3. jonathan m. glauser, infection control and the emergency department, emergency med. reports, october 15, 2007, at 2, available at 2001 wlnr 20428074 (citation omitted). 4. mccaughey, supra note 2, at i (citation omitted). 5. glauser, supra note 3, at 2 (citation omitted). 6. pathogens are "disease-producing organisms." polin, supra note 2. 7. id. 8. id. 9. id. 10. see ann huletsky et al., identification of methicillin-resistant staphylococcus 2010] who should pay 337 mrsa is a type of staphylococcal ("staph") infection resistant to a number of antibiotics.11 mrsa became a problem in facilities worldwide in the 1960s, 12 and the first mrsa infection was reported in the united states in 1968.13 healthcare-acquired or hospital-acquired mrsa ("ha­ mrsa") cases have one or more of the following patient risk factors: ( 1) presence of an intravenous line, a catheter, a feeding tube, or other invasive device; (2) prior mrsa infection or colonization14; (3) recent antibiotic use; (4) recent or current contact with a facility including surgery, hospita­ lization, dialysis, or residence in a long-term care facility within the pre­ vious year; or (5) testing mrsa-positive more than forty-eight hours after facility admission.15 ha-mrsa accounts for eighty-five percent of all mrsa infections. 16 mrsa is spread throughout facilities when mrsa­ positive patients are admitted without being tested or isolated.17 facilities generally see an increase in all categories of staph infections once mrsa has been found in a patient already in the facility. 18 it logically follows that the sooner mrsa-infected or colonized patients are isolated from other patients the less likely it is for them to spread mrsa. the presence of mrsa has increased healthcare costs significantly. 19 healthcare costs associated with mrsa in the united states alone were around six billion dollars in 2005, and are increasing each year?0 recent studies have shown that facilities are capable of controlling the spread of aureus carriage in less than 1 hour during a hospital surveillance program, 40 clinical infectious diseases 976, 976 (2005). 11. centers for disease conttol and prevention, mrsa in healthcare settings [hereinafter mrsa in healthcare setting.s], http://www.cdc.govlncidod/dhqpl ar_mrsa_spotlight_2006.html. qast visited march 30, 2010). 12. r. monina klevens et al., invasive methicillin-resistant staphylococcus aureus infections in the united staies, 298 jama 1763, 1764 (2007). 13. 3 hum. resources series: policies & practices§ 219:21 (thomson reuters/west 2008) [hereinafter hr series: policies & practices]. 14. colonization or colonized means mrsa bacteria is carried on the patient or in the patient's nasal passages but he does not have any symptoms. mrsa in healthcare settings, supra note 11. 15. klevens et al., supra note 12, at 1765. as opposed to communityacquired-mrsa ("ca-mrsa"), defined as: "infections that are acquired by persons who have not been recently (within the past year) hospitalized or had a medical procedure (such as dialysis, surgery, catheters)." richard p. evans, the silent epidemic: ca-mrsa and ha-mrsa, 2 am. acad. of orthopaedic surgeons now, may 2008, at 2, available at http://www.aaos.orglnews/aaosnow/may08/researchl.asp. this note will not address ca­ mrsa, the definition is merely given to help the reader distinguish between ha-mrsa and ca-mrsa as currently classified. 16. evans, supra note 15, at2-3. 17. mathieu eveillard et al., impact of screening for mrsa carriers at hospital ad­ mission on risk-adjusted indicators according to the imported.mrsa colonization pres­ sure, 59 j. of hosp.infection 254,256-57 (2005). 18. jane d. siegel et al., management of multidrug-resistant organisms in healthcare seitings, 6 (center for disease control and prevention 2006) (2006), availa­ ble at http:/ lwww.cdc.gov/ncidod/dhqplpdf7ar/mdro0uideline2006.pdf. 19. huletsky et al., supra note 10, at 976. 20. id. 338 indiana health law review [vol. 7:335 ha-mr.sa by implementing effective preventative measures.21 several ·facilities have been successful in limiting the transmission of ha-mrsa by implementing procedures to reduce the spread of the infection. detec­ tion of mrsa-positive or colonized patients at the time of facility admis­ sion is. the only way to implement isolation and contact precautions which will reduce the subsequent spread ofha-mrsa.22 therefore, screening all patients upon facility admission would greatly reduce the possibility that a mrsa-positive patient will come into contact with otherwise healthy pa­ tienu~. it is estimated that seventy to ninety percent of mrsa-colonized p,1tients are not identified23and without screening, more than half will re­ main undetected,24 increasing the likelihood ofha-mrsa transmission. since studies have shown that mrsa can be controlled by proper screening procedures and other preventative measures, facilities face liabil­ ity when a patient contracts ha-mrsa while in their care. the extent of facility liability depends on the duty owed to the patient, the standard of care in other similar facilities, whether there was a breach in the standard of care or duty, and the causal relationship between the breach of the standard ofcare or duty and the patient's injury.25 currently, when a patient receives improper care while in a facility he is eligible to bring a variety of tort claims against the facility, including, negligence, medical malpractice, and vicarious liability. therefore, a pa­ tient who contracts ha-mrsa from a facility is able to bring a suit re­ questing compensation for damages suffered as a result of contracting the infection. ha-mrsa and other hospital-acquired infections were once considered an inevitable part of facility care and facilities billed for them accordingly, but with growing evidence that facilities can take steps tore­ duce infections26 and new private insurance and medicare/medicaid poli­ cies that refuse to pay for hospital-acquired infections, facilities face a greater risk of patient suits. mrsa highlights a growing concern for the medical industry. facili­ ties struggle with numerous issues including: what duty, if any, is owed to patients, workers, or visitors when a mrsa-positive patient is in the care of a facility; what is the standard of care for mrsa-positive patients; what 21. id 22. m. h. wernitz et al., effectiveness of a hospital-wide selective screening pro­ gramme for methicillin-resistant staphylococcus aureus (mrsa) carriers at hospital ad­ mission to prevent hospital-acquired mrsa lrifections, 11 bur. soc'y of clinical microbiology & infectious diseases 457, 457 (2005). 23. mccaughey, supra note 2, at 5. 24. eveillard et al., supra note 17, at 257. ·25. dan b. dobbs, the law of torts 269,631,633-34, & 668-70 (west group 2nd reprint 2002) (2000); jay m. zitter, causes of action 2d 79 (24th ed., 2007), available at 24 coa.2d 79 (2007) (westlaw). 26. vanessa fuhrmans, insurers stop paying for care linked to mistakes, the wail street journal, january 15, 2008, available at 1115/08 apdatastream 15:54:39 (westlaw). 2010] who should pay 339 duty, if any, exists to isolate mrsa-positive patients; what preventative measures are required to reduce the spread of mrsa; which patients should be screened for mrsa; is consent to screen required; and who should be billed for mrsa screening? until the cdc or the medical industry imple­ ments national standards and procedures for handling mrsa, individual facilities face liability when patients contract ha-mrsa. this note discusses lawsuits based on ha-mrsa, staph infections, and other diseases and the screening and preventative measures adopted by some facilities that have successfully reduced ha-mrsa transmission. in order to facilitate a better understanding of why screening and preventative measures are necessary, section ii explains the background of mrsa, modes of mrsa transmission, and mrsa's growing resistance to all anti­ biotics. section iii weighs the importance of facilities taking preventative measures and offers details regarding medicare/medicaid and private insur­ ance policies' reduction of coverage for secondary infections.27 section iii also compares the cost of prevention to the cost of treating a mrsa­ infected patient. section iv introduces the various tort claims a patient who contracts ha-mrsa might bring, the extent of facility liability, and. recent legislation passed in several states requiring facilities to test patients for mrsa. ii. background a. the history of mrsa in the last decade mrsa has become a healthcare concern for many individuals because it has reached significant numbers not only in health­ care settings, but in community settings as well. mrsa first became an issue in facilities around the world in the 1960s,28 and the united states reported its first mrsa infection in 1968.29 roughly 2.3 million ameri­ cans were colonized with mrsa in 2005,30 and these numbers are increas­ ing each year. the rate of hospital patients infected with mrsa increased from two percent in 1974; to forty percent in 1997;31 to sixty-four percent in 2003; and continues to increase each year.32 annually, more than 126,000 mrsa-positive patients report to u.s. hospitals requiring treatment.33 27. this note uses the terms "secondary infection," "hospital-acquired infection," "healthcare-acquired infection," and "nosocomial infection" interchangeably. 28. klevens et al., supra note 12, at 1764. 29. hr series: policies & practices, supra note 13. 30. centers for disease control and prevention, s. aureus and mrsa surveillance summary 2007 [hereinafter mrsa surveillance 2007], http://www.cdc.gov/ncidod/ dhqp/ar _ mrsa_ surveillancefs.html (last visited november 7, 2008). 31. hr series: policies & practices, supra note 13. 32. mccaughey, supra note 2, at 1. 33. mrsa surveillance 2007, supra note 30. 340 indiana health law review [vol. 7:335 in the united states, mrsa infections tripled from 2000 to 2005 and were ten times higher in 2005 than 1995.34 in 2005, there were "368,600 hospital admissions for mrsa-including 94,000 invasive infections[,]"35 about eighty-six percent of which were healthcare-acquired.36 the ·coc found that mrsa killed nearly 19,000 people in the united states in 2005, a number higher than victims of hurricane katrina and aids combined the same year.37 a survey preformed by the association for professionals in infection control and epidemiology reported that forty-six of every 1,000 patients were infected with mrsa, meaning that 1.2 million hospitalized patients are infected with mrsa. 38 with numbers like this, it is possible that mrsa is killing almost 120,000 patients a year.39 due to the increas­ ing number of mrsa infections in facilities and the community, preventa­ tive measures must be taken to reduce its transmission. b. transmission of mrsa mrsa is transmitted through direct skin-to-skin contact, contact with shared items or surfaces (such as towels, bandages, bedrails, privacy cur­ tains, and gloves) that have come into contact with someone else's colo.;. nized or infected skin, and the failure of healthcare personnel to wash their hands between patient contacts.40 healthcare workers and their failure to wash their hands,41 as well as person-to-person contact with individuals who have open draining wounds or are asymptomatic carriers, 42 are the most common modes of transmission in facilities. bacteria survive on healthcare workers' hands after patient contact unless soap and water or an alcohol-based hand sanitizer is used.43 mrsa and other nosocomial infec­ tions pose the greatest risk in facilities that fail to follow standard hand­ washing procedures. a healthcare worker's hands may become contami­ nated when she touches the skin of a mrsa-colonized or infected patient.44 the most common healthcare workers who fail to wash their hands between 34. evans, supra note 15, at 2. 35. /d. 36. mrsa surveillance 2007, supra note 30. 37. evans, supra note 15, at 2. 38. medical errors and patient safety, [july 2008] health pol'y tracking service­ issue brief080714.25 at p.s (july 14, 2008). 39. /d. 40. see generally glauser, supra note 3, at 1-3; see also a al-hamad & s. maxwell. how clean is clean? proposed methods for hospital cleaning assessment, j. of hosp. infection 1, 1-2 (2008), doi: 10.1016/j.jhin.2008.08.006. 41. mrsa in healthcare settings, supra note 11. 42. glauser, supra note 3, at 7. asymptomatic carriers are colonized with mrsa, which can be revealed by nasal swab testing. id 43. mrsa in healthcare settings, supra note 11. 44. /d 2010] who should pay 341 patient contacts are physicians.45 the first line of defense for facilities should be to monitor healthcare workers for compliance with hand~washing procedures 8fter contact with every patient. healthcare workers also need to wash their hands after coming in contact with the environment of a. pa~ tient who is either a mrsa~arrier or is mrsa-positive. studies have shown that mrsa can also contaminate the patient's .en­ vironment. 46 these studies found that almost ~fourths of patient rooms contained mrsa bacteria. 47 mrsa has been found on door handles, furni­ ture, equipment, patient charts, stethoscopes, gowns, clothes, room curtains, nurses' keyboards, and telephones.48 mrsa has the ability to survive on dry surfaces for weeks; including the surface of packaging for sterile goods for more than thirty-eight weeks.49 therefore, touching a mrsa~ contaminated environmental source, and then touching a patient, increases the likelihood that patients will acquire ha~mrsa.50 the environment where a mrsa-positive patient stayed while in the facility needs to be tho­ roughly cleaned with an alcohol-based disinfectant after patient discharge. the nurses' station and equipment also need to be disinfected routinely to reduce transmission of mrsa. 51 facilities that have been successful in eliplinating mrsa have: (1) implemented procedures requiring staff to wear disposable gowns when entering the rooms of patients carrying mrsa; (2) used disposable blood pressure cuffs; and (3) put strict cleaning procedures in place for equipment that came into contact with mrsa­ positive or mrsa-colonized patients.52 due to mrsa's growing resis­ tance to numerous antibiotics, it is imperative that facilities qdce measures to reduce its transmission. c. mrsa resistant to almost all antibiotics · mrsa has developed resistance to almost every antibiotic used to treat it since 1968: "including synthetic variants of~cillin such as methi­ cillin, cephalosporins, penems and carbapenems."5 it has also developed resistance to the purely synthetic strain of antibiotics known as fluoroquino­ lones. 54 mrsa' s resistance to ciprofloxaxin, a fluroquinolone, occurred in 45. glauser, supra note 3, at 1. 46. al-hamad & maxwel, supra note 40, at 2. 47. mccaughey, supra note 2, at 4. 48. see al-hamad & maxwell, supra note 40, at 5; see also mccaughey, supra note 2, at4. 49. al-hamad & maxwell, supra note 40, at 5. 50. see id. at 1. 51. see id. 52. mccaughey, supra note 2, at 6. 53. eric kades, preserving a precious resource: rationalizing the use of antibiotics, 99nw. u. l. rev. 611,615 (2005). 54. id 342 indiana health law review [vol. 7:335 just one year. 55 very few antibiotics still work to treat mrsa, and the few ''that may still work include vancomycin (v ancocin, v ancoled), trimetho­ prim-sulfamethoxazole (bactrim, bactrim ds, septra, septra ds), linezolid (zyvox), tetracycline [(terramycin)], or clindamycin [(evoclin)]."56 due to mrsa' s ability to mutate and become resistant to most other antibiotics,! vancomycin, has become the antibiotic of "last resort" for treatment of mrsa, however, even vancomycin has failed to be effective because some strains of mrsa are now exhibiting signs of resistance to it57 mrsa's resistance to drug treatment is a growing concern for the healthcare industry, because once mrsa becomes resistant to all antibio­ tics, facilities will be unable to treat patients who have mrsa. therefore, the ·only way to stop mrsa from becoming a "super bug"58 is to implement other preventative measures in facilities and reduce the reliance on treat­ ment with antibiotics. iii. preventative measures 1hat work and new insurance poucies preventing cost-recovery for secondary infections a. preventative measures several· facilities that have implemented procedures to reduce the spread of ha-mrsa have had success in limiting its transmission. poly­ merase chain reaction ('~pcr") tests have been developed that are able to test for mrsa and provide results in two to four hours and cost only twen­ ty-five to thirty dollars per test. 59 pcr testing is relatively inexpensive, and facilities that implement pcr testing can isolate mrsa-colonized or posi­ tive patients within a few short hours. other countries, and some facilities in the united states, have eradicated transmission of ha-mrsa by adopt­ ing procedures to identify and isolate mrsa-positive patients on admis­ sion.60 facilities .can keep ha-mrsa infection rates low or nonexistent 55. id. 56. healtir.ine, staphylococcal diseases, http://www.healthline.com/ adamcon­ tent/mrsa (last visited january 29, 2009). 57. kades, supra note 53, at 615 (citation omitted). 58.. super bugs are antibiotic-resistant bacteria that are able to "outsmart antibiotics so that these medicines no longer work well." wfbmd, v ancomycjn~reslstant enterococci (vre), hup://www.webmd.comla-to-z-guideslvancomycin-resistant-enterococci-vre-overview (last visited january 29, 2009). 59. united states general accountability office, health-care-associated infections in hospitals, an overview of state reporting programs and individual hospital initiatives to reduce certain infections, ga0-08-808, at 8 (2008) [hereinaf­ ter state reporting of health~are-associated infections), available at http://www.gao.gov/new.items/d08808.pdf. ''pcr is a highly sensitive, molecular testing technique that detects mrsa-specific dna" id. 60. id. 2010] who should pay 343 with the implementation ofmrsa-screening and other safety precautions.61 . the programs that have been successful in limiting transmission· of ha­ mrsa are based on early identification of mrsa-positive patients and subsequent isolation of those patients suspected ofbeing or testing mrsa­ positive. 62 to reduce the risk of liability, facilities need to enforce hand hygiene, policies by monitoring staff and physicians for compliance and implement­ ing punishment for policy violations.63 facilities should also implement policies that require healthcare workers to wear gowns and gloves . when contact with a potential mrsa-positive patient or equipment. used on a mrsa-positive or colonized patient occurs.64 some facilities have imple­ mented the use of signs at entrances of rooms containing mrsa-positive patients as a reminder to staff and visitors to follow all contact precau­ tions.65 facilities should disinfect equipment, such as door knobs, bedrails, telephones, and wheel chairs, between uses, make checklists to ensure housekeeping staff properly disinfect rooms when mrsa-positive or colo­ nized patients are discharged, and change privacy curtains as ways to ensure the eradication of mrsa bacteria prior to placing new patients in the room.66 facilities should also flag patient charts if the patient has tested mrsa-positive and use techniques to identify the patient as having a for­ mer mrsa-positive culture in order to implement the same contact precau­ tions upon readmission.67 the facilities studied that implemented the precautions recommended above reduced ha-mrsa infection rates by fif­ ty to seventy-four percent.68 the facilities that reported increases in costs from implementing the preventative measures still reduced their overall costs because they were treating fewer patients with mrsa infections. 69 one hospital in north carolina screened all patients entering the hos­ pital for mrsa.70 within eight months, the north carolina hospital had reduced its number of ha-mrsa infections by sixty .percent.71 a yale­ affiliated hospital in connecticut reduced ha-mrsa infections by two61. see id 62. menno r vriens et al., methicillin-resistant staphylococcus aureus carriage among patients after hospital discharge, 26 infection control and hosp. epidemiology 629, 629 (2005) (citations omitted), available at http://www.journals. uchi­ cago.edu/doi/pdf/1 0.1086/502592. 63. see state reporting of healtii-care-associated infections, supra note 59, at 29. 64. see id at 29-30. 65. see id at 30. 66. id 67. id 68. id. at 32. 69. state reporting of health-care-associated infections, supra note 59, at 36. 70. fuhnnans, supra note 26. 71. /d. 344 indiana health law review [vol. 7:335 thirds after implementing patient screening measures.72 a boston hospital found that routine culturing of patients and implementation of contact pre­ cautions for mrsa patients resulted in a sixty-seven percent drop in infec­ tion rates.73 the boston hospital believed it would have reduced ha­ mrsa infection rates even more if it either isolated patients until results were received, or used the rapid pcr mrsa test, which produces results in a couple of hours, instead of the culture method, which produces results in two days. 74 the university of virginia hospital discovered that identifying every mrsa-positive and colonized patient by testing all patients and iso­ lating those harboring mrsa bacteria enabled it to eliminate mrsa from the hospital after an outbreak, not only once, but twice. 75 the united states governmental accountability office ("gao") sampled fourteen different hospitals that had implemented procedures to reduce the transmission of mrsa.76 the gao discovered that, even though each hospital tested different patient populations and used various testing procedures, each facility conducted routine mrsa-screening.77 three of the fourteen hospitals tested every patient for mrsa, and the other eleven hospitals tested patients in adult or neonatal intensive care units. 78 all fourteen hospitals implemented changes to the procedures for hand hy­ giene, and more than half of the hospitals increased contact precautions and improved their procedures for disinfecting environmental surfaces. 79 after the implementation of preventative measures, each hospital reported a de­ cline in the number ofha-mrsa infections.80 the gao and other studies demonstrate that facilities that not only test patients for mrsa, but also implement preventative measures to reduce its transmission are successful. these studies also show that if facilities are not testing patients, they have no idea which patients are mrsa-positive or colonized. these facili­ ties are capable of spreading mrsa simply by touching mrsa-positive or colonized patients and then touching mrsa-negative patients. one study found that twenty-four percent of patients with mrsa nasal colonization develop infections within one to forty-six days of having a positive screen.81 this study shows that colonized patients and patients who are already showing signs of mrsa infection pose the same health risk to mrsa72. mccaughey, supra note 2, at 9. 73. !d. 74. id 75. id at 12-13. 76. state reporting of heal1h-care-associated infections, supra note 59, at 5. 77. ld 78. id 79. !d. 80. id 81. adam keene et al., staphylococcus aureus colonization and the risk of infection in the critically ill patients, 26 infection control and hosp. epidemiolooy 622, 624 (2005), available at http://www.joumals.uchicago.edu/doi/pdt71 0.1086/502591. 2010] who should pay 345 negative patients. based upon the gao report and other studies that dem­ onstrate the modes of mrsa transmission, facilities should face liability when they fail to enact preventative measures to eliminate the spread of ha-mrsa. b. medicare/medicaid and private insurance policies forbidding payment of secondary infections the centers for medicare and medicaid services ("cms") announced in may, 2006 that it would no longer reimburse facilities for costs asso­ ciated with preventable errors.82 cms' goal is to hold facilities and pro­ viders responsible for errors in the hope that the quality of care will improve and there will be a decline in the number of medical errors. 83 as of october 1, 2008, facilities no longer receive additional payments based on the presence of a secondary infection caused by a "never event."84 not only can facilities not receive additional payments from cms, cms' poli­ cy prevents facilities from passing the costs associated with "never events" on to patients. 85 mrsa is currently classified as a nosocomial infection, and nosocomial infections associated with surgeries or indwelling86 cathe­ ters are listed as one of cms' "never events!.s7 mrsa could also fall un­ der the category of hospital-acquired stapylococcus aureus bloodstream infections being added to the cms' list of "never events" in 2009.88 it is also possible that mrsa could soon have its own listing on the cms' list of "never events" because cms evaluates and updates the list of ''never events" annually.89 many private insurance companies have followed 82. sheryl tatar dasco & kathryn e. higgins. the "never" events: what it means for physicians, 10 no. 3 j. healrn care compuancb 33, 33 (2008)(citations omitted). 83. id.; but see rachel deutsch, the federal role in reducing hospital-acquired conditions: are medicare reimbursement incentives enough?, 42 colum. j.l. & soc. probs. 1 (2008). 84. a never event refers to an event that should never occur in the healthcare field. tatar dasco & higgins, supra note 82, at 33. (citations omitted). examples of ''never events" include: leaving a foreign object in a patient after surgery; medication errors, such as giving a patient the wrong medicine; giving a patient the wrong blood; performing surgery on the wrong body part; performing surgery on the wrong patient; and patient death ftom use of contaminated devices. /d. at 35. 85. /d. at 34 (citations omitted). 86. indwelling refers to the use of a tube in an "organ or passage to maintain drainage, prevent obstruction, or provide a route for administration of food or drugs." merriam­ webster's medical dictionary http://medical.merriam-webster.com/medical/indwelling (last visited february 15, 2009). 87. trisha torrey, learn more about medicare's 2008 never events policy there's more to it than just patient. safety, http://patients.about.com/od/ patientempowermentis­ sues/a/medicare08never.htm (last visited november 8, 2008); torrey, supra note 1. 88. centers for medicare & medicaid services office of pubuc affairs, cms proposes to expand quality program for inpatient services in fy 2009 (april 14, 2008), http://www.cms.hhs.gov/apps/media!presslrelease.asp?counter=l863. 89. see centers for medicare & medicaid services office of pubuc affairs, 346 indiana health law review [vol. 7:335 cms' lead and are now refusing payment for secondary infections.90 aetna and wellpoint, two of the largest private health insurers, have started incorporating cms' policy into their contracts with facilities.91 aetna's new contracts specifically state that it will neither pay for, nor let facilities bill patients for, an event that is on cms' list of ''never events."92 the idea behind cms and private insurers' policies is to improve safety measures and make facilities face liability for the costs associated with fail­ ing to implement procedural safeguards.93 if medical personnel followed all procedures they have been taught, facilities could reduce hospital-acquired infection rates by almost ninety percent.94 in light of the cdc and reduce infection deaths' ("rid") fmdings that patients develop nearly two million infections in hospitals each year, and over 100,000 deaths occur as a result of hospital-acquired infections, insurers have had to impose policies that shift the costs to the facilities.95 rid found that hospital-acquired infections add $30.5 billion in treat­ ment costs each year.96 the cdc also found that common "never events" add more than $4.5 billion a year in treatment costs, and antibiotic-resistant bloodstream infections, such as mrsa, add as much as $100,000 in treat­ ment costs per patient.97 the added costs of treating secondary infections offer facilities an incentive to implement procedures for reducing errors.98 a north carolina hospital that implemented mrsa screening for every patient who entered the facility found that private and public insurers were more than willing to pick up most ofthe cost for screening each patient if it meant reducing the costs associated with treating secondary infections.99 it cost the hospital approximately $1 million to screen every patient who en­ tered; however, insurers paid $800,000 of the $1 million and the hospital reduced ha-mrsa infections by sixty percent. 100 the reduction in ha"' mrsa infections alone saved the hospital more than the $200,000 cost as­ sociated with mrsa-screening. the hospital would have spent more than that to treat just a few patients who contracted ha-mrsa and would have been unable to recoup any of the money for the nosocomial infection from incorporating selected national quality forum and never events into meidcares list of hospital-acquired conditions (april 14, 2008), http://www.cms.hhs.gov/ apps/media/press/factsheet.asp?counter-=3043 90. fuhrmans, supra note 26. 91. jd. 92. /d. 93. see id. 94. margot sanger-katz, accountability in mind; sisters watched their mother suffer from infection in hospital, concord monitor, march 2, 2008, available at 2008 wlnr 5642653, at 4 (westlaw 2008). 95. fuhrmans, insurers supra note 26; see also mccaughey, supra note 2, at i. 96. mccaughey, supra note 2, at i. 97. fuhrmans, supra note 26. 98. id. 99. /d. 100. ld. 2010) who should pay 347 cms, insurers, or patients. c. the costs to treat versus the costs to prevent mrsa studies of united states hospitals have shown that in 1999 the cost to treat a mrsa infection was $27,083 to $34,000 per patient, and healthcare costs associated with mrsa treatment were around $6 billion annually.101 in 2003, "it cost $14.5 billion to treat [mrsa] in [united states] hospit­ als."102 due to the increase in the number ofmrsa cases in recent years, it is safe to assume the healthcare costs associated with mrsa treatment have risen. facilities are rarely reimbursed for the added costs to treat a patient who contracts a secondary infection.103 for example, a pittsburgh hospital that treated a patient for pancreati­ tis would have made a profit had the patient not contracted ha-mrsa; in­ stead the hospital lost $41,813.104 patients who contract staph infections, including mrsa, increase hospital costs by more than three times the cost of treatment for their uninfected counterparts.105 mrsa infections can in­ crease costs for routine surgeries to over $1 million in a short amount of time, 106 and research shows it costs more to treat ha-mrsa infections than it would cost to implement a screening program.107 another pittsburgh facility reduced ha-mrsa infections by ninety percent when it implemented mrsa-screening in its intensive care unit.108 the screening cost the facility $35,000, but prevented enough ha-mrsa infections to reduce facility costs for treatment of those infections by $801,000.109 two facilities in south carolina that implemented targeted screening programs spent $113,955 on the screening, but saved the facili­ ties $1,548,740 in what would have been treatment costs for ha-mrsa infections had the screening not been done.110 another facility found that even adding in the costs for collecting samples, laboratory testing of sam­ ples, using barrier protection supplies, time spent taking protective meas­ ures, and isolation amounted to only $35,281; an amount dwarfed by the $801,652 to $2,015,919 expected costs for treating ha-mrsa infec101. ann huletsky et al., supra note 10, at 976. 102. mccaughey, supra note 2, at 25. 103. /d. at 21. 104. id 105. id at 22. 106. see sanger-katz, supra note 94, at 4. 107. see mccaughey, supra note 2, at 23. facilities will argue that they are financially strapped now and requiring them to test all patients for ha-mrsa only increases their debt and may put them out of business. this is. a weak argument because insurers are willing to pay for testing and it costs more to treat a mrsa infection than it does to pay for the costs associated with prevention. fuhrmans, supra note 26. 108. mccaughey, supra note 2, at 23. 109. /d. 110. /d. 348 indiana heal til law review [vol. 7:335 tions.m that facility had an annual savings of $766,371 to $1,980,638 for ha-mrsa alone.112 savings this significant indicate why cms and private insurers' adopted policies holding facilities responsible for the costs of secondary infections and "never events." cms and private insurers' new policies enhance a patient's chances of winning a negligence, medical malpractice, or vicarious liability suit for contracting ha-mrsa. by including mrsa in categories on its "never events" list, and possibly adding it as a separate "never event", cms and private insurers are taking the position that facilities have the ability to pre­ vent patients from contracting ha-mrsa while in their care. while it is possible that some ha-mrsa infections may be unpreventable because a patient was tested and did not test mrsa-positive, it is rather unlikely. a facility would still be subject to suit by the patient who contracted ha­ mrsa. n. analysis: why facilities should be held liable under .claims of negligence, medical malpractice, or vicarious liability a. the law in the united states research has shown that ha-mrsa is preventable when recom­ mended guidelines are followed and facilities are no longer shielded from liability.113 now, when a patient receives improper care from a facility, he is eligible to bring a number of tort claims against the facility. contracting ha-mrsa should be considered improper facility care since several ac­ credited institutions have published recommended guidelines for the im­ plementation of mrsa-testing and preventative measures. a patient who contracts ha-mrsa can bring tort claims for negligence, medical malprac­ tice, and vicarious liability. when a patient contracts an infection from a facility the patient is re­ quired to prove three or four elements to succeed on a claim for the hospit­ al-acquired infection.114 the patient must show: (1) the· standard of care applicable to the defendant [facility] or its employees; (2) that the [facility] breached such standard; [] (3) that a proximate caus­ al relationship existed between the [facility's] breach of duty and the injury suffered by the patient, either based on direct evidence, or under the doctrine of res 111. ld at 24. 112. jd 113. id. at 26. 114. zitter, supra note 25. 2010] who should pay ipsa loquitur[;]115 [and (4)] [i]fthe action is based on the [facility's] vicarious liability for the negligence of an employee, the plaintiff must also show the exis­ tence of a principal-agent relationship between the [facility] and the employee sufficient to impose lia­ bility on the [facility]. 116 349 in most jurisdictions, in order for a patient to establish the standard of care required by the facility, she will be required to provide medical expert tes­ timony.117 the expert can show that the employee violated accepted stan­ dards of professional practice, and that the deviation from those standards was the cause of the patient's hospital-acquired infection.u8 professional standards arise not only from mandatory industry standards, but also from the voluntary undertaking of recommended regulations and policies.119 for example, a facility that voluntarily undertakes the standards set out by the cdc, society for healthcare epidemiology of america, infectious diseases society of america, institute for healthcare improvement, and healthcare infection control and prevention advisory committee (collectively, "go­ verning agencies") for mrsa may have patients use those standards to show the facility breached the appropriate duty of care. 120 patients will also argue that a facility's failure to use the governing agencies' guide­ lines for reducing ha-mrsa infections by testing patients, taking isolation precautions, and implementing hand-washing procedures makes it liable to the patient under negligence, medical malpractice, or vicarious liability. 121 the facility undertakes the duty to provide a clean environment with sterile techniques and instruments as soon as a facility-patient relationship 115. res ipsa loquitur "means the thing speaks for itself. .. the plaintiff's injury and the immediate events surrounding it can by themselves show negligence, even though the plaintiff is unable to prove any specific act that was unreasonably dangerous." dobbs, supra note 25, at 370. 116. zitter, supra note 25. 117. james walker smith, hospital liability§ 4.03(l}(alm properties, inc., law journal press, a division of american lawyer media, inc. 2008). 118. id 119. i d. facilities will argue that screening all patients for mrsa is a voluntary under­ taking they are not presently required to take because the cdc and other governing agencies in the medical community have not mandated mrsa-screening. therefore, the vohmtary undertaking would be increasing the applicable standard of care owed to patients and sub­ jecting facilities to liability they were not previously subject to. this argument will likely fail because multiple studies have shown that while the cdc and other governing agencies' do not mandate mrsa-screening or particular infection control practices for mrsa, the facilities that implemented the recommended guidelines for mrsa-screening and infection control practices have reduced the spread ofha-mrsa. see generally mccaughey, supra note 2. 120. smith,supranote 117. 121. see mccaughey, supra note 2, at 26. 350 indiana health law review [vol. 7:335 arises.122 a facility was once able to escape liability in negligence, medical malpractice, and vicarious liability cases if it could show that it was follow­ ing the standard of care in the community; however, that defense is inade­ quate today since the guidelines for best practices are published and nationally available.123 facilities will only escape liability if: (1) the patient does not prove the appropriate stan­ dard of care; (2) the [facility] and its employees ex­ ercised reasonable care in preventing the patient's contraction of an infection; (3) the conduct of the [facility] or its employees was not the proximate cause of the patient's infection; (4) no inference of negligence was available under res ipsa loquitur; [and] (5) in an action based on vicarious liability, it was not shown that the allegedly negligent caregiver was the agent of the [facility]. 124 . therefore, a facility that fails to follow, or has an employee breach, the recommended standards of care set out by the governing agencies faces increased chances for being held liable by a court when a patient conttacts ha-mrsa or another healthcare-acquired infection. the patient, who con­ tracts ha-mrsa, or another healthcare-acquired infection, has the greatest chance of succeeding on a claim for negligence. 1. negligence patients who contract ha-mrsa must prove five elements to estab­ lish a prima facie case of negligence against the facility. 125 first, the pa­ tient must show that the facility owed her a duty of care. 126 second~ that the facility breached its duty by its conduct.127 third, that the facility's conduct in fact caused harm to the patient.128 fourth, that the facility's conduct was not only a cause in fact of the patient's harm, but was also a proximate cause.129 fifth, that the patient suffered damages in a definable amount, "based on actual harm of a legally recognized kind such as physi122. james walker smith, hospital liability§ 7.02 (alm properties, inc., law journal press, a division of american lawyer media, inc. 2008). 123. see mccaughey, supro note 2, at 26. 124. zitier. supra note 25. 125. dobbs, supra note 25, at 269. 126. id. 127. id. 128. /d. 129. /d. proximate cause means ''that the [facility's] conduct is perceived to have a significant relationship to the harm suffered by the [patient]." id 2010) who shouw pay 351 cal injury to" the patient.130 a patient need only establish the elements of negligence by proof or persuasion to establish a prima facie case against a facility.131 patients in the past may have faced difficulty in establishing that the facility owed them a duty of care because the healthcare industry had not implemented standards for dealing with mrsa. since recent studies have shown that facilities that implement preventative screening measures reduce the trans­ mission of ha-mrsa, patients should now be able to show that facilities have the duty to implement preventative measures, including patient screen­ ing, or face liability. facilities can be held liable for negligence by their employees132 under the doctrine of corporate negligence.133 in cases where a patient acquires ha-mrsa, it is likely the patient will sue the facility because the particu­ lar employee at fault may prove difficult to discover and the employees usually do not have the ability to pay large judgments like the facility does. corporate negligence requires the facility to exercise reasonable care for patient safety by maintaining a safe environment, only hiring and retaining physicians who are competent, monitoring all personnel practicing medi­ cine regarding care of patients, and adopting and enforcing procedures and policies that provide safe and quality care for patients.134 facilities, there­ fore, can, and should, be held liable in negligence for failure to take the ne­ cessary precautions to protect patients from acquiring ha-mrsa. a patient who contracts ha-mrsa only has to prove that the facility breached the duty of care to him by failing to practice proper hygiene, take preventative measures, diagnose mrsa infection, etc. in kapuschinsky v. united states, a facility was found liable for neg­ ligence when a premature baby in a neonatal intensive care unit contracted staph, and tests of the nursery staff revealed that one nurse was positive for staph.135 the facility was held negligent because it permitted the nurse to work in the neonatal intensive care unit and premature nursery prior to hav­ ing the nurse submit to a nose or throat culture or physical exam. 136 the facility's negligence arose when it permitted the nurse to work with infants with compromised immune systems without testing her, knowing the nurse 130. dobbs, supra note 25, at 269. 131. id. 132. kapuschinsky v. united states, 248 f. supp. 732,735 (d. s.c., 1966) (quoting 96 a.l.r.2d 1205, 1207). 133. the doctrine of corporate negligence "creates a nondelegable duty which the [fa­ cility] owes directly to a patient .... [and] an injured party does not have to rely on andes­ tablish the negligence of a third party .... [it] arises from the policies, action, or inaction of the [facility] itself, rather than the specific acts of individual [facility] employees." gahm v. thomas jefferson university hospital, 2000 wl 23324 7, 2 (e.d.pa., 2000). 134. id 135. kapuschinsky, 248 f. supp. at 734-35. 136. id. at 737. 352 indiana health law review [vol. 7:335 had previously worked in various hospital wards, including a pediatrics clinic taking care of both sick and well children.137 the court combined circumstantial evidence to find that the infant was infected with staph bacte­ ria and that the only way the infant could have been infected was by the nurse who tested positive for staph.138 strains of staph can be the same even though they appear resistant to different antibiotics, "because when the organism 'passes from one individual who is a carrier, to a second individu­ al who develops a clinical infection, -the organism frequently becomes resistant to more antibiotics .... 139 a facility breaches its duty to a patient when it permits a nurse, who previously worked in a ward with mrsa­ infected patients, to come into contact with infection-susceptible patients without giving the nurse a physical exam or testing for drug-resistant bacte­ ria colonization or infection. 140 in negligence actions, a facility is liable if it fails to meet the national standards specified by the joint commission on accreditation of hospitals or other similar accredited standards by other accredited bodies for other facilities of its kind.141 conformity with the standard of care observed by other [facilities] in good standing in the same com­ munity cannot necessarily in itself be availed of as a defense in a negligence action where criterion relied upon is shown to constitute negligence, in that it fails to guard against injuries to the patient in failure to meet standards of care self imposed or established. 142 *** to relieve a member of the medical profession from liability for injury to a patient on the ground that he followed a degree or standard of care practiced by others in the same locality is ... unthinkable when the degree or standard of care· in question is shown to constitute negligence because it fails to meet the test of reasonable care and diligence required by the med137. id. at 748 (citation omitted). 138. /d. at 742-43. 139. id. at 743. this case and note are not suggesting that all facility employees must be tested for mrsa after contact with every mrsa-colonized or mrsa-positive patient, they are merely stating that facility employees who care for patients colonized or infected with mrsa should be tested prior to working in an area of the facility that cares for immu­ no-compromised patients. 140. seeid 141. see kapuschinsky v. united states, 248 f. supp. 732, 744 (d. s.c., 1966) (citing duling v. bluefield sanitarium, inc. 142 s.e.2d 754, 765 (w.va. 1965)). 142. !d. at 747 (citation omitted). 2010] who should pay 353 ical profession. 143 known precautions for the safety of patients must be taken, despite what other facilities are doing. 144 negligence law has established that there is a greater need for caution when the danger is more probable. 145 ha-mrsa should not be treated differently than the staph infection in kapuschinsky, and facilities should be held liable for the failure to test healthcare workers and other patients entering the facility for colonization or infection with mrs a. similarly, in helman v. sacred heart hospital, the court found the facility liable for helman's contraction of staph while in defendant's fa­ cility and the jury awarded helman damages totaling $67,839.97.146 hel­ man's roommate complained of a boil under his arm and the next day drainage was apparent; however the roommate was not transferred out of helman's room and into isolation until four days later. 147 nurses and atten­ dants taking care of both helman and his roommate "moved from one pa­ tient to the other, changed sheets, gave sponge baths, changed dressings, administered back rubs, and in general, carried out the necessary hospital routine for the care of the two men[,]" without observing the facility's ste­ rile techniques when infection was suspected.148 the nurses failed to wash their hands or leave the room between contacts with helman and his room­ mate.149 the day that helman's roommate was placed in isolation for hav­ ing tested positive for staph, helman's surgical site began draining the same type of discharge as his former roommate's boil and a culture confirmed helman had staph.150 the jury found that enough circumstantial evidence existed to confrrm the nurses and attendants infected helman with staph from his roommate. 151 · in maldonado v. sinai medical group, inc., maldonado alleged negli­ gence against his physicians for failure to diagnose a bone infection, which left him a paraplegic.152 the court found that while maldonado was being treated for a staph infection, physicians failed to investigate a cat scan after maldonado complained of back and abdominal pain.153 medical ex­ pert testimony revealed that the deterioration in maldonado's spine was 143. id. (citation omitted). 144. see id. (citation omitted). 145. id. at 748 (citation omitted). 146. helman v. sacred heart hospital, 381 p.2d 605, 606 (wash. 1963). 147. jd. at 606-07. 148. id. at 606. 149. id. at 606-07. 150. id. at 607. 151. see id. at 611. 152. maldonado v. sinai medical group, inc., 2008 wl 161671, slip op. at 2-3 (n.d. ill. 2008). 153. id. at 3. 354 indiana health law review [vol. 7:335 consistent with osteomyelitis which correlated with the back and abdominal pain and had it been diagnosed sooner, maldonado could have avoided pa­ ralysis.154 in kimberly f. v. mary hitchcock memorial hospital, the facility was found liable for negligence and medical malpractice when kimberly f. con­ tracted ·genital herpes while in the facility giving birth. 155 kimberly f. was placed in a room with a patient who had genital herpes and healthcare workers, in caring for both patients, failed to wash their hands between pa­ tient contacts.156 the facility was held liable because it admitted a patient known to have genital herpes, took that patient off of infection precautions, and placed her in a room with kimberly f. while she was still exhibiting symptoms of an active infection. 157 this case demonstrates the failure of healthcare workers to observe standard hand-washing procedures when a patient was known to be infected with an incurable disease. mrsa is more contagious and fatal than genital herpes, and facilities owe patients the duty to abide by standard procedures for treatment and recommended guidelines for handling mrsa infections. two other cases settled based on negligent acts by facilities. the ftrst facility reached an $825,000 settlement with a plaintiff who alleged his father's leg amputation, and later death from an ha-mrsa bloodstream infection, was caused by negligent care given while in the facility.158 the second facility entered a $3,815,000 settlement for negligent care of a pa­ tient who suffered from a decubitus ulcer and resulting mrsa infection and later died from pneumonia. 159 the facility failed to treat the decubitus ulc­ er for nineteen days and failed to notify physicians; thus, allowing the mrsa infection to spread to the bone.160 one hospital in florida has been sued by thirteen separate patients claiming he contracted ha-mrsa from the facility while there for surgery.161 recent cases and settlements show that facilities are facing liability for negligence when a patient contracts mrsa, staph, or another hospital­ acquired infection while in their care. it appears that it would be more cost effective for facilities to implement preventative measures and monitor healthcare workers for compliance in order to eliminate the spread of drug­ resistant organisms than it would be to continue paying damages based on findings ofliability. 154. id. at 2-3. 155. kimberly f. v. mary hitchcock memorial hospital, 1993 wl 498026, 1-2 (1st cir., 1993). 156. id. 157. jd. at 3-5. 158. moore v. west oaks geriatrics center, 2005 wl 3690831 (d. tex. 2005). 159. smith v. senior living properties, llc, 2002 wl 32155086 (d. tex. 2002). 160. id 161. mccaughey, supra note 2, at 27. 2010] who should pay 355 2. medical malpractice causes of action for medical malpractice require the patient to prove the same five elements of negligence, plus a sixth element: a failure of the physician to meet ''the standard of care of other professionals in the same field."162 this standard is referred to as the professional-peer standard; 163 the trier of fact must determine if the physician's conduct conformed to the medical standards or customs in the community in which the physician practices.164 courts usually require the patient to establish the professional standard using expert testimony. 165 medical experts testify whether the procedure is medically acceptable in the physician's community, and if the procedure is acceptable, if it is considered the medical standard. 166 a patient who contracts ha-mrsa will have a more difficult time proving medical malpractice than negligence. the malpractice case is more difficult because the governing agencies have currently only recommended guidelines regarding standards to be used for mrsa and have yet to require mandatory practices. however, some ha-mrsa cases have succeeded on medical malpractice claims. the new jersey superior court, appellate division, in colucci v. op­ penheim, found that the trial court erred when it found that colucci did not have a cause of action for medical malpractice because the trial judge im­ properly excluded plaintiff's counsel from drawing inferences for the jury.167 colucci developed a mrsa infection at his surgery site and the treating doctor referred to it as a low-grade infection.168 a few days later, colucci reported to the hospital and his infection was diagnosed as mrsa. 169 the mrsa infection spread throughout colucci's body and he went into a coma, suffered from brain abscesses, lung problems, heart murmurs, blood infection, kidney failure, and spinal abscesses.17° colucci's claim for medical malpractice stated that the treating physician who per­ formed his initial surgery deviated from the accepted standard of care by performing the particular surgery on colucci despite colucci's background and susceptibility to infection.171 the physician also deviated in the stan­ dard of care for treatment after surgery regarding the pin sites that later be162. dobbs, supra note 25, at 631 (citations omitted). 163. ld. 164. id. at 633. 165. id. (citation omitted). 166. jd. at 633-34. 167. see colucci v. oppenheim, 740 a.2d 1101, 1108-09 (n.j. super. ct. app. div. 1999). 168. see id. at 1105. 169. seeid 170. jd. 171. see id 356 indiana health law review [vol. 7:335 came infected. 172 colucci was granted a new trial on his claim for medical malpractice. medical malpractice cannot be shown unless the patient can point to specific acts or omissions by the facility, or physician, for the harm suf­ fered.173 a patient is required to show more than just mrsa's presence in the facility, she must show that some act or omission by the facility or physician was the cause of her injury in order to be awarded damages. 174 in crist v. dean, even though crist contracted ha-mrsa from st. vincent hospital, the source of the ha-mrsa infection was unknown because crist had never been tested to see if she carried the infection, the skin graft was not tested prior to its use, and none of the staff were tested. 175 to succeed in a malpractice claim there must be some evidence to determine the source of the infection.176 had crist demonstrated the source of her ha-mrsa infection, she might have succeeded on her malpractice claim. just like crist, many patients who contract ha-mrsa are suing for medical mal­ practice, increasing the number of medical malpractice claims being filed. the city of philadelphia has more than double the national median for malpractice case filings, and "plaintiffs prevail in 44% of verdicts ... with 24% of awarded verdicts in excess of $1 million."177 mrsa was responsi­ ble for forty-five of the 154 cases brought by plaintiffs in philadelphia.178 it is easier for a patient to show that a facility failed to adhere to the standards of care when a patient contracts ha-mrsa because ha-mrsa is consi­ dered a preventable secondary infection.179 facilities are more prone to medical malpractice suits now that studies have demonstrated that one-third of healthcare-acquired infections are preventable by implementing infection control programs.180 the forty-five philadelphia ha-mrsa cases for mal­ practice were surgeries performed on "clean body site[ s] (i.e., knees, ster­ num) and these areas should have the lowest incidence of preventable 172. seeid. at l105. 173. see crist v. dean, 2007 wl 266444, slip op. at 5 (ark. app. 2007). 174. see id. at 6. 175. seeid.at1-2. 176. see id. 177. john l. guinan et al., a descriptive review of malpractice claims for health care-acquired infections in philadelphia, 33 am. j. of infection control 310, 310 (2005), available at http://ovidsp.tx.ovid.eom.proxy.ulib.iupui.edu/spalovidweb.cgi? weblink.fra­ meset=l&s=oafdfpjjdhddionkmcglidnkinfiaaoo&retumurl= http%3a%2fll/o 2fovidsp.tx.ovid.com%2fspa%2fovidweb.cgi%3 fll/o26full%2btext%3dl %257 cs.sh.15.16.1 8.40%257c0%257c00000545-200506000-000 11 %26s%3doafdfpjjdhddionkmc glidnkinfiaaoo&directlink=http%3a%2:f%2fgraphics.tx.ovid.com%2fovftpdfs%2ffpd dmcnkidnkdh00%2ffs046%2fovft%2flive%2fgv023%2id0000545%2id0000545200506000-000 11.pdf&filename=a +descriptive+review+of+malpractice+claims+for+ health+care-acquired+infections+in+philadelphia. 178. /d. 179. /d. 180. /d. 2010] who shouw pay 357 [healthcare-acquired infections]."181 poor compliance with basic hand hy­ giene is assumed in nearly fifty percent of the malpractice cases when mrsa and other infections transmitted by direct contact with contaminated hands are indicated. 182 malpractice cases also arise where a physician fails to diagnose mrsa. in bindhammer v. cubelli, bindhammer brought a medical malprac­ tice action against the physician for failure to obtain a deep wound culture and to recommend an infectious disease consult at the first sign of infection to determine whether mrsa was the causative agent. 183 two months later, bindhammer's mrsa infection was discovered and he subsequently un­ derwent fifteen more surgeries to treat the infection.184 malpractice was found and bindhammer received a jury verdict for damages of $1.6 mil­ lion.185 in another malpractice case, a jury awarded $2.58 million to a retiree who acquired a staph infection and lost his right leg, part of his left foot, a kidney, and some hearing.186 another hospital settled for $815,000, and the nursing home settled for $130,000, in a case brought by a patient who con­ tracted ha-mrsa causing him to have an amputation of his right leg be­ low-the-knee and to have a calcanectomy187 of his left foot.188 in another case, a physician settled a medical malpractice claim for $2.2 million be­ cause he failed to properly treat the plaintiff's husband for a mrsa infec­ tion.189 the physician discharged the plaintiff's husband twenty-three hours after surgery while he was suffering from a fever, pain, and an elevated white blood cell count, which a few days later resulted in a mrsa infection draining into the husband's abdomen subsequently causing his death. 190 it appears that patients who bring medical malpractice cases for ha­ mrsa or staph succeed just as often as those patients who bring negligence cases. the growing trend indicates that facilities either settle, or juries find in favor of patients who contracted ha-mrsa. juries are finding that fa­ cilities have a duty to prevent transmission ofha-mrsa and are awarding compensation accordingly. facilities should implement procedures and 181. ld. 182. /d. 183. bindhammer v. cubelli, 2007 wl 3101672, slip op. at 1-2 (n.j. super. ct. app. div. 2007). 184. /d. at 1. 185. id. at 3. 186. william c. lhotka, $2.58 million awarded in suit, st. louis post-dispatch, july 31,2008, available at 2008 wlnr 14240517, at 1 (westlaw 2008). 187. calcanectomy refers to an incision or sectioning of the calcaneus (heel) bone. see merriam-webster's medical dictionary http://medical.merriam-webster.com/ medi­ cal/calcaneus (last visited february 1, 2009); see miriam-webster's medical dictionary http://medical.merriam-webster.com/dictionaryltomy. 188. reilly v. augustana nursing home, 2007 wl 4976276 (n.y. sup. 2007). 189. dossantos v. zarif, 2003 wl 23221495 (conn. super. ct. 2003). 190. id. 358 indiana health law review [vol. 7:335 infection control practices· to reduce liability for hospital-acquired infec­ tions.191 3. vicarious liability facilities can be held liable for the negligent acts of their employees, if those acts are committed within the scope of employment. 192 vicarious liability permits a patient to recover against both the facility and the doctor or nurse for damages when she contracts ha-mrsa. 193 vicarious liability exists because the doctor or nurse is not only acting on his or her own be­ half, but as an employee of the facility.194 courts have begun to recognize that a facility owes patients a non-delegable duty of care and thus causes harm· to patients when it fails ''to provide appropriate ·services, equipment, and staff support, or in negligently selecting, training, reviewing, or super­ vising physicians who are permitted to use the [facility's] resources."195 in frigo v. silver cross hospital and medical center, the facility was found negligent for failing to require a physician to go through a surgery residency before operating on patients.196 frigo suffered a staph infection in her foot· after dr. kirchner operated on it. 197 the infection progressed and frigo's foot had to be amputated; hence, she brought suit against silver cross hospital and medical center and dr. kirchner for negligence, mal­ practice, and breach ofduty.198 frigo was awarded $7,775,668.02 by a jury against silver cross and dr. kirchner settled before trial for $900,000.199 the hospital was held liable for the negligent acts of dr. kirchner in failing to monitor and treat frigo's foot infection in the proper manner because: [a]s a matter of public policy, ... [facilities] are in the best position to protect their patients and, conse­ quently, have an independent duty to select and retain competent independent physicians seeking staff privi191. facilities will argue that implementing procedures and infection control practices for mrsa without national mandates is undertaking a new duty, not previously owed to the patient that adds costs to an already struggling healthcare system. the increased costs could detrimentally affect the inpatient healthcare delivery system that is already in financial crisis due to low reimbursement rates and care for the indigent, a crisis that is dramatically increas­ ing with the failing economy. nevertheless, facilities that have implemented procedures and infection control practices for mrsa have not appeared to incur substantial costs; therefore, the facilities' argument is weak. 192. dobbs, supra note 25, at 668 (citations omitted). 193. dobbs, supra note 25, at 669 (citations omitted). 194. id. (citations omitted). 195. id at 670 (citations omitted). 196. frigo v. silver cross hospital and medical center, 876 n.e.2d 697, 702-3 (ill. app. ct. 2007). 197. id 198. id 199. id 2010] who should pay leges .... [t]he [facility's] liability extends only to the physician's conduct while rendering treatment to patients in the [facility] and does not extend to his conduct beyond the [facility's] premises .... [t]he [facility] will only be responsible for the negligence of an independent physician when it has failed to ex­ ercise due care in the selection and retention of that physician on its staff.200 359 the jury held the facility liable for frigo's injuries because frigo's experts established that dr. kirchner lacked surgery experience and failed to treat frigo's ulcer and infection properly.201 had the facility not granted dr. kirchner surgery privileges, frigo's foot amputation would not have oc­ curred.202 the court found proximate cause between the facility's negli­ gence in ·giving dr. kirchner surgery privileges without following the bylaws and credentialing requirements and frigo's amputation sufficient to uphold the jury's findings.203 in maldonado, the plaintiff tried to hold the facility vicariously liable for the actions of its physicians in negligently failing to diagnose his bone infection.204 the court found vicarious liability for the facility did not exist because maldonado failed to produce evidence to show that the facility was negligent in its performance of managerial or administrative :functions.205 in contrast, the facility in kimberly f. was held vicariously liable for the healthcare workers' failure to follow isolation precautions, the physician releasing the infected patient from isolation precautions, and the nurse's failure to relay to the physician the infected patient's active infection.206 not much case law exists mentioning a facility's vicarious liability for the actions of nurses or physicians. it is safe to assume, however, that when a facility is found liable due to healthcare workers' failure to follow hand-washing procedures, isolation precautions, and other standards of care, that the court is relying on vicarious liability or the doctrine of corpo­ rate negligence. vicarious liability is possible when the facility has a stan­ dard of care or policy regarding safe practices to reduce the spread of mrsa and other infections, and the physician or nurse fails to follow the standard of care or policy. vicarious liability can also arise when a facility 200. ld. at 721-22 (citations omitted). 201. jd. at 726. 202. frigo v. silver cross hospital and medical center, 876 n.e.2d 697, 726 (ill. app. ct 2007). 203. ld. 204. maldonado v. sinai medical group, inc., 2008 wl 161671, slip op. at 6-7 (n.d. til. 2008). 205. jd. 206. kimberly f. v. mary hitchcock memorial hospital, 1993 wl 498026, 1-2 (1st cir., 1993). 360 indiana heal til law review [vol. 7:335 does not have a standard of care or policy set out regarding safe practices for reducing the spread ofmr.sa and other infections. verdicts in negligence, medical malpractice, and vicarious liability cases involving ha-mrsa appear to be quite costly to facilities. if facili­ ties implemented preventative measures and patient-screening on admission for mrsa, they would reduce their liability and cut costs for treating ha­ mrsa infections. several state ·legislatures have taken the position that facilities should be held liable and have enacted legislation requiring fa­ cilities to test patients for mrsa. b. recent legislation due to the increase in mrsa infections over the last eight years, sev­ eral states have proposed or adopted legislation requiring facilities·to take more proactive measures to reduce transmission of mrsa.2°7 facilities claim they should not be mandated to implement screening measures be­ cause each facility has implemented their own program to handle health­ care-acquired infections, but legislators are not listening to the facilities.208 the legislators are more concerned with the public demand for more ag­ gressive approaches that reduce the spread of ha-mrsa, especially in light of the cdc's findings that six out of seven patients with a mrsa in­ fection contracted it from a facility.209 four states, in 2007, enacted legisla­ tion requiring facilities to screen for mrsa, eight states considered similar legislation in 2008, and a few other states have proposed similar legislation for the 2009 session.210 1. pennsylvania in 2007, pennsylvania became the first state to mandate facility re­ porting of all healthcare-acquired infections to the state counci1.211 the state council is required to issue a public report identifying the number of patients infected with healthcare-acquired infections by facility name.212 pennsylvania's state legislature also enacted legislation requiring facilities to test all high-risk patients for mrsa and other drug-resistant bacteria. 213 despite these regulations, facilities must also test employees who have had 207. kevin b. o'reilly, states consider requiring hospitals to screen for mrsa, am. med. news, february 16, 2009, available at http://www.ama-assn.org/amednews/2009/02/ 16/prsb0216.htm. 208. /d. 209. id 210. id 211. medical errors and patient sqfety [year-end 2007], health pol'y tracking ser­ vice-issue brief080107.6 at p. 2 (january 7, 2008) [hereinafter issue brief080107.6]. 212. ld at2-3.; 40 pa. cons. stat.§ 1303.404 (2007). 213. issue brief080107.6, supra note 211, at 4. 2010] who should pay 361 contact with contagious patients, use a patient infection-tracking system, and establish and implement state-approved infection control practices.214 facilities are not increasing operating expenses by testing all high-risk pa­ tients and employees for mrsa because the legislature also enacted legis­ lation compelling insurers and medical assistance programs to reimburse facilities for healthcare-acquired infection screening.215 starting in 2009, pennsylvania began rewarding quality improvement payments to facilities that complied with enacted mandates and reduced healthcare-acquired in­ fection rates by ten percent in the preceding year. 216 2. california the california legislature enacted legislation requiring all facilities to report adverse events within five days to the department of health. services and if the event is a threat to patient safety, welfare, or health, it must be reported within twenty-four hours.217 mrsa is likely to be classified as an adverse event if a patient contracts ha-mrsa while being treated for another condition in the facility and would be required to be reported in five days. mrsa will also be classified as a threat to patient safety, health, and welfare if a patient reports to the facility and tests positive within the first forty-eight hours of admission, requiring the facility to report the mrsa infection within twenty-four hours to the department of health ser­ vices. california also enacted legislation in 2007 requiring facilities to test patients for mrsa within twenty-four hours if: (1) the patient is suscepti­ ble to infection and is having inpatient surgery; (2) the patient was dis­ charged from a facility within the previous thirty days; (3) the patient is being placed in the bum or intensive care unit; or (4) the patient receives dialysis.218 facilities are also required to implement infection control pro­ cedures and to appoint an infection control officer who ensures that mrsa­ testing and reporting are carried out. 219 infection control procedures re­ quire, at a minimum, proper disinfection of all patient rooms, nursing sta­ tions, and other environmental sources where mrsa bacteria may be present.22° facilities must also provide oral and written instructions to all patients who test mrsa-positive regarding the care needed to treat 214. ld.; 40 pa. cons. stat.§ 1303.403(a) (2007); 40 pa. cons. s'rat. § 1303.404(e-f) (2007). section 1303.403(a)(4) specifically requires facilities to identity patients colonized or infected with mrsa upon facility admission. 215. 40 pa. cons. stat.§ 1303.406 (2007). 216. 40 pa. cons. stat.§ 1303.407 (2007). 217. issue brief080107.6, supra note 211, at 3; cal. healtii& safety code§ 1279.1 (2007). adverse events include most of the cms' list of'llever even,ts." 218. cal. heal til & safety code§ 1255.8(s)(bxl)(a-e)(2007). 219. cal.healm&safetycode§ 1255.8(5xf)(2007). 220. cal. heal til & safety code§ 1255.8(5xex2)(2007). 362 indiana health law review [vol. 7:335 mrsa.22t 3. new jersey the new jersey legislature enacted legislation requiring facilities to use routine screening for mrsa as a matter of public health and to incorpo­ rate best practices as recommended by the governing agencies of the med­ ical community.222 the facilities are required, at ftrst, only to implement the infection control practices in high-risk areas such as surgical units, or intensive care units, but the facility must expand the infection control prac­ tices to the entire facility as quickly as possible.223 eventually, the facili­ ties should be testing all patients upon admission for mrsa, have contact precautions in place, and report the number of cases of ha-mrsa to the department of health. 224 4. illinois the illinois legislature enacted legislation requiring all facilities to implement mrsa control practices that test all high-risk patients for mrsa upon admission.225 the facilities must maintain records and report all cases of mrsa to the department of health for publication in the hos­ pital report card.226 all patients that test mrsa-positive are required to be isolated and hand-washing procedures must be followed.227 illinois facili­ ties must also follow the guidelines set out by the cdc for mrsa and oth­ er drug-resistant organisms. 228 5. tennessee the tennessee legislature requires all facilities to perform a risk as­ sessment for mrsa in each facility. those facilities that have not seen a reduction in cases of ha-mrsa must implement a statutorily required in­ fection control program. 229 the mrsa control programs· should include 221. cal. health& safety code§ l255.8(5)(d)(2007). 222. n.j. rev. stat.§ 26:2h-12.35 (2007). 223. n.j. rev. stat.§ 26:2h-12.36 (2007). 224. § 26:2h-12.36. 225. 210 ill comp. stat. 83/5 (2007); 210 ill. comp. stat. 83/6.23 (2007). 226. 210 ill comp. stat. 83/5 (2007); 210 ill. comp. stat. 83/10(2007). the hospit­ al report card is a report necessitated by the hospital report card act which requires all illinois facilities to prepare a quarterly report that details the hours worked by all nurses each day and how many covered each facility area, all infection control procedures, and the number of mrsa or other bloodstream infections treated or discovered in critical care units to the state department of health. 2101ll. comp. stat. 86125 (2007). 227. 210 ill comp. stat. 83/5 (2007). 228. 210 ill. comp. stat. 83/6.23 (2007). 229. tenn. code ann.§ 68-11-269 (west 2009). 2010] who should pay 363 employee and patient education, testing of all high-risk patients, contact precautions, increased hand-washing procedures, and intra-facility commu­ nication regarding the status of mrsa-positive patients being trans­ ferred.230 6. new hampshire, indiana, district of columbia, virginia, and texas new hampshire statutes require facilities to follow the recommenda­ tions of the medical community's governing agencies and implement mrsa-testing for all patients, isolation of mrsa infected or colonized patients, and hand-washing and environmental source disinfection proce­ dures~231 indiana law currently requires facilities to report error rates to the state department of health.232 during the 2009 indiana legislative ses­ sion, a bill was introduced that would require facilities to develop infection control programs to reduce ha-mrsa and submit annual reports on the number of mrsa infections in the facility to the state department of health.233 similarly, the district of columbia municipal regulations require facilities to report the number of patients with mrsa infections, test all patients at high-risk for mrsa, and disclose the number of mrsa­ outbreaks in the facility.234 the district of columbia also requires each facility to have written infection control practices, identify all mrsa­ colonized or infected patients in high-risk units, isolate all mrsa-infected or colonized patients, chart identification of all patients with prior mrsa infection, provide employee and patient education as to mrsa­ transmission, and implement and enforce hand-washing policies.235 the virginia legislature enacted legislation requiring all lab directors to report mrsa infections to the state department of health within three days.236 similarly, texas statutes require labs to report all cases ofmrsa to the program director.237 the texas legislature also enacted legislation requiring the health and human service commission to research and im­ plement programs for reporting mrsa in all facilities.238 based upon state legislatures' reactions to the recent epidemic of 230. § 68-ll-269(b)-(c). 231. n.h. coder. dep't. healtii & hum. services§§ 301.04 to 301.05 (weil)(june 13, 2008). 232. issue brief080107.6, supra note 211, at 3. 233. h.b. 1539, 116th gen. assem., 1st reg. sess. (ind. 2009), available at http://www.in.gov/apps/lsa/session!billwatchlbillinfo?year=2009&session=l&request=getbi ll&doctype=hb&docno"'l539 (last visited march 9, 2009). 234. 22 d.c. codemun. regs.§ 207.1-207.3(weil2009). 235. 22 d.c. code mun. regs. §§ 2038.1 to 2038.7 (weil 2009); 22 d.c. code mun. regs.§§ 3267.1 to 3267.7 (weil2009). 236. healthcare providers and facilities snapshot, [november 2007] health pol'y tracking service-snapshot 071128.3 at p. 7 (november 28, 2007) (citation omitted). 237. tex. heal til & safety code ann.§ 81.0445 (2007). 238. § 81.0445. 364 indiana health law review [vol. 7:335 mrsa, it appears that facilities will soon be required to test, at a mini­ mum, high-risk patients for mrsa upon facility admission. facilities will also be required to report all cases of mrsa in or presented to them to state agencies. without implementing the preventative measures pub­ lished nationally and found to be effective by many studies, state legislation is forcing facilities to face liability with the potential for large verdicts against the facilities. v. conclusion mrsa infections greatly increase treatment costs, and in recent years facilities have seen an increase in liability to patients who contract ha­ mrsa. a facility's failure to implement the recommended best practices for handling mrsa should make it liable to any patient who subsequently contracts ha-mrsa. facilities owe patients a duty of care to keep patients safe from ha-mrsa, and should be required to test all patients upon ad­ mission. testing patients is not unreasonable due to the development of pcr tests that can determine a patient's mrsa-status within two hours at a relatively low cost. studies have shown that facilities that have eradicated the spread of ha-mrsa have implemented procedures for identifying and isolating mrsa-colonized and mrsa-positive patients, strict cleaning practices, and other strict policies for healthcare workers to follow when treating mrsa-infected patients. facilities can decrease the risk of liability by enforcing hand hygiene policies, monitoring healthcare workers for compliance, implementing pu­ nishment for violations of the policy, and requiring healthcare workers to wear gowns and gloves when contact with potential mrsa-positive pa­ tients or equipment used on mrsa-positive patients occurs. facilities should also disinfect equipment and rooms with alcohol-based disinfectants between uses, make checklists to ensure housekeeping staff properly disin­ fect rooms when mrsa-positive patients are discharged, and change priva­ cy curtains as ways of ensuring eradication of mrsa bacteria. facilities should also have measures for flagging patient charts if the patient has tested mrsa-positive in the past so that staff can implement the same con­ tact precautions upon readmission. the implementation by cms and private insurers of policies that refuse to pay for, or let patients be billed for, "never events" provides facil­ ities more of an incentive to implement recommended precautions to pre­ vent ha-mrsa infections, or they will be left absorbing the costs of treatment. facilities that do not implement safety precautions to guard against ha-mrsa face the possibility of an increased number of patient lawsuits and larger verdicts against them based on the increase in patient awards over the last five years in ha-mrsa cases. patient screening for mrsa is a duty of care owed to all mrsa-negative patients entering a fa­ cility. if facilities fail to screen, the consequences can be fatal; therefore, 2010] who should pay 365 facility liability for the failure to take relatively inexpensive recommended precautions is warranted. altered standards of care for health care providers in the pandemic influenza t eleanor d. kinney* heather a. mccabe .. amy lewis gilbert­ janna jo shisler .... table of contents i. introduction ••.••••••••••••.••.•••.•••••..••••••••••••.•.•••••••••••.•••••••..••••••••••••••••• 2 ii. standards of care ......................................................................... 2 a. the standard of care under current law ................................... 2 1. tort standard of care ........................................................... 3 2. relevant state medical liability laws .................................. 4 3. regulatory standards of care ............................................... 5 b. professional development of the content of the standard of care ............................................................................................. 6 ill. state authority and altered standards of care .................. 7 a. setting the altered standard of care for a public health emergency .................................................................................... 8 b. modifying liability rules for conduct during a public health emergency .................................................................................... 9 n. challenges .................................................................................... 10 a. triage methodologies ................................................................ 10 t notice: this legal white paper was prepared by the williams. and christine s. hall center for law and health at the indiana university school of lawindianapolis in conjunc­ tion with the indiana university center for bioethics under contract with the indiana state de­ partment of health as part of the project "translating ethics advice into practice: public and professional outreach about pandemic influenza planning in indiana." the views expressed in this document are those of the authors and may not necessarily reflect the opinions of the center for bioethics, hall center for law and health, indiana university, clarian health partners, inc., or the indiana state department of health. • hall render professor of law and co-director, william s. and christine s. hall center for law and health at the indiana university school of law-indianapolis; j.d. duke university school oflaw, m.p.h. university ofnorth carolina at chapel hill, m.a university of chicago, b.a. duke university. the authors wish to thank many of whom assisted with the preparation of this white paper, including ms. jennifer lemons and ms. margaret ann welsh. •• director, public health law program, william s. and christine s. hall center for law and health at the indiana university school oflaw-indianapolis; j.d. indiana university school oflawindianapolis, m.s.w. indiana university school ofsocial work, b.a. indiana university ... j.d. indiana university school oflawindianapolis, m.p.h. alabama university­ binningbam, b.a. boston university •••• j.d;, ll.m., indiana university school oflaw-indianapolis, b.a. indiana university. 2 indiana health law review [vol. 6:1 b. standard of care for the distribution of vaccines and antivira/s .................................................................................... 12 c. worliforce management and altered standards of care ........... 13 i. absenteeismofemployedhealth care workers ................. 13 2. use ofvolunteer health care professionals ...•................... 15 v. conclusion .................................................................................... 16 i.introducflon pandemic influenza will pose tremendous challenges to health care pro­ viders, state public health authorities, and the public. all will have to conduct business under the most adverse of circumstances. it will be difficult for pro­ viders to meet the customary legal standards of care imposed by state and fed­ eral regulatory authorities, as well as the common law tort system. this white paper will explore the legal issues associated with altered standards of care in pandemic influenza. ll.standardsofcare the concept of"standard of care" has several different meanings depend­ ing on the context. in medicine, public health, and the other health professions, "standard of care" refers to accepted standards acknowledged by the profession as defining acceptable and appropriate practice. increasingly, these standards are developed by professional organizations, accrediting bodies, and govern­ ment agencies in processes that vary greatly in their democratic characteristics.• development efforts are designed to clarify, establish, and codify professional standards of care in an organized and accessible manner.2 the concept of"standard of care" also has distinct meanings in the law. the term refers to a legal standard that must be followed to avoid liability, sanc­ tions, or other legal consequences. of note, the term "liability'' is basically equivalent to legal accountability and, under civil law, generally involves the payment of compensation when such liability is found. sanctions are imposed under regulatory or criminal law, wherein the latter imposes a range of remedies and penalties for violations of various legal standards of conduct established in criminal statutes. a. the standard of care under cu"ent law there are three primary legal standards of care that will be most relevant during pandemic influenza, particularly during the time of the surge. these are: 1. see eleanor d. kinney, behind the veil where the action is: private policy and american, 51 admin. l. rev. 154, 154-155 (1999). 2. see eleanor d. kinney, the brave new world of medical stondards of care, 29 j. l. med. & ennes 323 (2001). 2009] care providers in the pandemic influenza 3 ( 1) tort standards pertaining to nonconsensual conduct that apply to all people; (2) regulatory standards for both health care facilities and health professionals; and (3) criminal standards that apply to all people. for purposes of this paper, we will not discuss applicable criminal standards of conduct; although it should be noted that, following hurricane katrina, criminal prosecutions were brought against nursing home owners for negligent homicide in not moving their pa­ tients prior to the storm. 3 1. tort standard of care in the tort standard of care, there are three predominant bases for liability: (1) liability for intentional conduct; (2) liability for negligent conduct, and (3) strict liability pertaining to certain activities. in intentional conduct, the tortfea­ sor is liable if he or she acts with "the pwpose of producing that consequence" or "knows to a substantial certainty that the consequence will ensue from the person's conduct.'"' negligent conduct is a more complex concept and involves risk analysis with respect to one's conduct vis-a-vis another person. the res­ tatement (3rd) torts emphasizes a balancing of the risk of injury if precaution is not taken versus the utility of taking precautions that may cost large amounts of money, stating: a person acts with negligence if the person does not ex­ ercise reasonable care under all the circumstances. pri­ mary factors to consider in ascertaining whether the person's conduct lacks reasonable care are the foreseea­ ble likelihood that it will result in harm, the foreseeable severity of the harm that may ensue, and the burden that would be home by the person and others if the person takes precautions that eliminate or reduce the possibility ofharm.5 the third basis of tort liability is strict liability, which pertains to injuries from abnormally dangerous activities, 6 and also from the manufacture and sale of defective consumer products. 7 the basic theory of strict liability is that the in3. adam nossiter, trial starts for owners of nursing home hit by storm, n.y. times, aug. 17, 2007, available at http://www.nytimes.com/2007 /08/17/uslnationalspecial/17nursing. html?partner=rssnyt&emc=rss; see also adam nossitier, nursing home owners acquined in deaths, n.y. times, sept. 8, 2007, available at http://www.nytimes.com/2007/09/08/usl nationalspecial/08nursing.html?fta=y. 4. restatement('fhird)oftorts § 1: liability for physical harm (proposed draft no.i 200 i). 5. id at§ 3. 6. id at §24. 7. id at§ i. 4 indiana health law review [vol. 6:1 jured party need not prove fault on the part of the responsible party once causa­ tion is established. 2. relevant state medical liability laws most states have enacted statutes to address tort liability of health care professionals. 8 in these states, the applicable standard of care varies by juris­ diction.9 in addition to setting the standard of care, states have also enacted statutes establishing pretrial procedural requirements, damage caps, and other reforms in an effort to reform the adjudication of malpractice cases.10 indiana has had such a medical malpractice reform since 1975.11 a majority of states have adopted a "national" standard of care, but a sig­ nificant minority still adheres to the "locality rule,'' which focuses on local cus­ toms to determine the appropriate level of care.12 the locality rule, developed over 100 years ago, was intended to protect rural and small town physicians who were presumed to be less informed and well equipped than colleagues in large cities.13 the standard of care enunciated under the strictest version of the locality rule measures the conduct of a physician against that of other physi­ cians in the same field operating within the same community.14 although most jurisdictions initially adopted the strict locality rule, many subsequently adopted a "modified locality rule" which is characterized as the degree of care, skill, and proficiency commonly exercised by ordinarily careful, skillful, and prudent 8. see, e.g., ala. code § 6-5-540 (2008), al.aska stat. § 09.55.530 (2008), ariz. rev. stat. ann. § 12-561 (2008), ark. code ann. § 16-114-201 (2008), cow. rev. stat.§ 13-64-101 (2007), del. code ann. m. 18, § 6801 (2008), d.c. code ann. § 162801 (lexisnexis 2008), fla. stat. § 766.101 (2008), ga. code ann. § 9-9-60 (2008), haw. rev. stat.§ 671-1 (2008), idaho code ann.§ 6-1001(2008), ill. comp. stat.§ 5/2-1701 (2008),1nd. code§ 34-18 (2006), iowa code§ 147.135 (2008), kan. stat. ann.§§ 60-3501 (2006), ky. rev. stat. ann. § 304.40-250 (west 2008), la. rev. stat. ann. § 40:1299.39 (2008), me. rev. stat. ann. tit. 24, § 2851 (2008),md. coooann.,healmocc. § 2a-01 (2008), mass. gen. laws ann. ch. 231 § 60b (west 2008), mo. rev. stat.§ 538.205 (2008), mont. code ann. § 27-6-101 (2007), neb. rev. stat. § 44-2801 (2008), nev. rev. stat.§ 41a003 (2007), n.h. rev. stat. ann.§ 507-c1 (2008), n.m. stat. ann. § 41-5-1 (west2008),n.c.gen.stat. § 99-21.50(2008),0hiorev.codeann. § 2323.41 (west2008),40pa. stat. ann§ 1303.501 (west2007), s.c.codeann. § 15-79-110(2007), tenn. code ann.§§ 29-26-1 (2008), tex. civ. prac. &rem. code ann.§ 74.001 (vernon 2007), utahcodeann. § 78-14-1 (2008), va.codeann. § 8.01-581.1 (2008), w.va. code § 55-78-1 (2008), wis. stat. § 654.001 (2007). see also michelle huckaby lewis, et al., the locality rule and the physician's dilemma: local medical practices vs the national stan4ard of care, 291 j. am. med. ass'n 2633 (2007). 9. see statutes cited supra note 8. 10. nationalc0nferenceofstatblegisla1ures,statbmedicalmaipracticetort laws (2005), available at http://www.ncsl.org/standcomm/sclaw/medmaltorttable205.htm. 11. ind. code § 34-18 (2006). 12. lewis et al., supra note 8, at 2633-34. 13. see, e.g., vergara v. doan. 593 n.e.2d 185 (ind. 1992); hall v. hilbwl, 466 so. 2d 856 (miss. 1985) (both cases discuss the history of the locality rule and cite to applicable stan­ dards of care in various states at the time of publication). 14. lewis et al., supra note 8, at 2634. 2009] care providers in the pandemic infwenza 5 physicians at the same time the treatment was provided and in similar locali­ ties.15 states are moving toward a national standard of care that evaluates wheth­ er the physician has exercised the "care and skill which is expected of a reason­ ably competent practitioner in the same class to which he belongs acting in the same or similar circumstances."16 most states adopting the national standard treat locality as one of several factors to be considered to determine whether a physician has acted reasonably under the circumstances.17 some states, howev­ er, apply a variation of the "locality rule," or apply both standards of care de­ pending on whether the physician is a specialist. 18 the district of columbia and twenty-nine states have adopted the national standard of care and twenty­ one states continue to maintain some version of the "locality rule."19 untill992, indiana followed the modified locality rule.20 that year, in vergara v. doan, the indiana supreme court established the following stan­ dard: "[a] physician must exercise that degree of care, skill and proficiency exercised by reasonably careful, skillful, and prudent practitioners in the same class to which he belongs, acting under the same or similar circumstances. "21 in so doing, the indiana supreme court adopted the national standard of care for indiana. 3. regulatory standards of care the health care sector is one of the most regulated areas in the economy of the united states. a myriad of state and federal regulatory regimes govern. both health care professionals and facilities to achieve a variety of regulatory objectives. these regulatory schemes involve both licensure and accreditation requirements. licensure and accreditation norms generally set regulatory standards for competence, and, increasingly, quality of services. licensure for both profes­ sionals and facilities tends to both define the characteristics of the profession or facility and establish criteria and standards for meeting these definitive charac­ teristics. accreditation is basically the same as licensure except that the survey and certification function is carried out by a private organization. often, as is the case with hospitals, accreditation by a private accrediting body, i.e., the joint commission on the accreditation of healthcare organizations 15. /d. 16. sara rosenbaum, the impact of united states law on medicine ll'l a profession, 289 j.am.meo.ass'n 1546,1551 (2003)(quotingshilkretv.annapolisemergencyhosp. ass'n, 349 a.2d 245,249-50 (md. 1975)). 17. lewis et al., supra note 8, at 2635. 18. id (see tbl. labeled box. interpretation and categories ofstate statutes and case law on standard of care). 19. id at 2634. 20. see vergara, 593 n.e.2d at 187. 21. /d. 6 indiana health law review [vol. 6:1 ("jcaho"), will be deemed to meet the conditions of state licensure and also the conditions of participation for third party payers. 22 the conditions required under licensure and accreditation may be one source to which a court looks as it determines whether or not a defendant has met the standard of care. the federal medicare program and joint federal-state medicaid programs have an array of statutory and regulatory prescriptions governing health care providers to ensure that program beneficiaries receive high quality care for which payment is made. 23 these standards are similar to licensure and accredi­ tation standards in terms of the conduct they require on the part of providers. given the experience in hurricane katrina, the centers for medicare and medi­ caid services ("cms"), the agency within the department of health and hu­ man services ("dhhs") that administers the medicare, medicaid, and schip programs, waived many of these standards because of the extraordinary diffi­ culties compliance would have imposed on providers. 24 specifically, cms waived liability for hospital emergency rooms under the emergency medical treatment and labor act ("emt ala") for transfer­ ring patients to other facilities for assessment if the original facility was located in an area where a public health emergency had been declared.25 cms also waived certain health insurance portability and accountability act ("hip aa") privacy requirements so that providers could talk to family members about a patient's condition when patients were unable to grant that permission to the provider. 26 b. professional development of the content of the standard of care it is important to appreciate that the ultimate source of these legal stan­ dards of care, particularly with respect to tort liability, are in fact professional norms.27 since the 1980s, the medical profession and its medical specialties have engaged in the development of more formal standards of care in all areas of medical practice.28 further, the current standard of care in tort accommodates the fact that 22. see eleanor d. kinney, private accreditation as a substitute for direct government regulation in public health insurance programs: when is it appropriate? 51 law & contemp. probs. 47, 50-57 (1994). 23. see eleanor d. kinney, the medicare, medicaid and schip programs meet the challenges of public health emergencies, 58 admin. l. rev. 559 (2006). 24. kaiser comm'n on medicaid and the uninsured, a comparison of the seventeen ap­ proved katrina waivers (jan. 2006), available at http://www.ldf.org/medicaidlupload/ 7420.pdf; see also priscilla d. keith, access to care issues consumers continue to face as a result of katrina, 2 a.b.a. health esource (dec. 2005), available at http://www.abanet. orglhealth/esource/vol2no4. 25. 42 u.s.c. § l320b-5(b)(3) (2009). 26. 42 u.s.c. §§ 1320b-5(b)(7)(a)(i) (2009); see also standards for privacy of indivi­ dually identifiable health information, 45 c.f.r. §§ 160-164 (2003). 27. see kinney, supra note 2. 28. seeid 2009] care providers in the pandemic influenza 7 there may be legitimate variations in the conditions under which services are delivered with language such as "in like or similar circumstances."29 certainly a state agency, with its authority to promulgate public health regulations, could establish standards of care by regulation if that agency's enabling legislation authorizes standard-setting activities. 30 thus, it is appropriate to rely on the flexibility of current standards to de­ velop protocols in conjunction with stakeholders. to the extent that they have been developed in a fairly transparent and democratic process, model protocols will be authoritative in establishing the most appropriate standard of care. in­ deed, governmental agencies have often adopted privately set standards in their regulatory programs.31 ill. state authority and altered standards of care the major sources of law that govern state public health matters are sta­ tutes that provide states the authority to protect and promote public health with­ in the state. most states also have specific statutes that authorize the governor of the state to declare an emergency and assume extraordinary powers to ad­ dress the emergency. 32 these statutes often immunize emergency and public health workers from liability for negligent conduct during the emergency.33 in 2006, indiana revised its laws regarding public health and other emer­ gencies to provide the governor with emergency powers, including rulemaking powers, and to waive liability for negligent conduct in certain instances. 34 un­ der indiana law, the governor has the power to declare a state of emergency, which triggers authorizations to engage in many emergency response activi­ ties.35 additionally, it is important to note two model acts that are widely circu­ lated. the first, the model state emergency health powers act developed by the center for law and the public's health at georgetown university school of law and the johns hopkins school of public health in collaboration with the centers for disease control and prevention ("cdc"), 36 has been somewhat 29. see kinney, supra note 22. 30. see eleanor d. kinney, administrative law approaches to medical malpractice reform, 49 st. louis u. l.j. 45 (2005). 31. see kinney, supra note i. 32. see sbarona hoffinan, responders' responsibility: liability and immunity in public health emergencies, 96 geo lj. 1913, 1923 (2008); james g. hodge. jr. et al., the legal framework/or meeting surge capacity through the use ofyohmteer health projessio11als during public health emergencies and other disasters, 22 j. contemp. heal1h l. & pol'y 5, 23-24 (2005). 33. hoffinan, supra note 32 at 1946-50; hodge, supra note 32 at 37-40. 34. ind. code§ 10-14-3-12 (west 2008). 35. /d. 36. modelstateemeroencyheal1hpowersacr §§ 101-810 (proposed official draft 2001 ), available at http://www.publichealtblaw .net/msehp aimsehp a2.pdf, see also lawrence 0. gostin, et al., the model state emergency health powers act: plamting 8 indiana heal1h law review [vol. 6:1 politically controversial. 37 the second, the turning point model state public health act,38 is developed by a collaborative group of public health policy makers and academics funded by the cdc and the robert wood johnson foundation. a. setting the altered standard of care for a public health emergency states do not require statutory authority to "alter" standards of medical treatment since such standards are established by professional organizations and individuals. under current law, states can convene relevant stakeholders to dis­ cuss and develop an altered standard of care pursuant to the conventional processes for developing standards by these persons and entities. 39 under a state's authority to act in public health emergencies and to issue rules and orders to proceed in such emergencies, the state could issue an order recognizing that the previously developed protocol will be the altered standard of care in the public health emergency. ostensibly, the governor could declare a previously developed protocol as the altered standard of care in the emergen­ cy at hand, although the governor need not take this step to assure that the pro­ tocols be authoritative. nevertheless, such a ruleor even a declaration­ would be useful in litigating cases and establishing the standard of care to be used in the situation. the indiana code gives the governor the power to issue rules and orders in the event of a public health emergency. 40 similarly, the turning point model public health act accords such authority as well.41 the most effective way to confer authority on a protocol establishing an altered standard of care in subsequent litigation is to develop the protocol be­ fore the emergency -using the ideal process described above. such a process would involve convening the major stakeholders from around the state to de­ velop the protocol in a transparent and democratic process involving broad confor and response to bioterrorism and naturally occurring infectious diseases, 288 j. am. med. ass'n 622 (2002). 37. see sue blevins, the model state_ emergency health powers act: an assault on civil liberties in the name of homeland security, heritage found. lecrure 748 (2002), available at http://www.heritage.orgiresearch/homejandsecurityihl748.cfin. (interestingly enough, this piece is a critique from the perspective of the conservative heritage foundation); george j. annas, response, bioterrorism and public health law, 288 j. am. med. ass'n 2685 (2002); george j. annas, bioterrorism, public health, and civil liberties, 346 new. eng. j. med. 1337 (2002); see also model st. emergency iiealtii powers act §§ 11-89 (proposed official draft 2002), available at http:/lwww.ncsl.org/progj:il1ilsibealth/modelact.pdf. . 38. model state pub. healm act§§ 1-101-9-106 (proposed official draft 2003), available at http://www.tumingpointprogram.~ageslpdfs/statute _mod/msphafinal.pdf, see also benjamin mason meier, et al., contrayting experiences of state public health law reform pursuant to the turning point model state public health act, 122 pub. healm rep. 559 (2007); james g. hodge jr., et al., transforming public health law: the turning point model state public health act, 33 j. l., med. & e'ihics 77 (2006). 39. see supra notes 22-26. 40. ind. code§ 10-14-3-22 (2006). 41. turnlngpointmodelstatepubucliealmacr § 6-102(dx1) (2002); see also modelstatepu8uciiealtiiemergencypowersacr§403(ax1)(2001). 2009] care providers in the pandemic influenza 9 sultation with interested parties and the public. also, the protocols would gain authority if they reflected consideration of other authoritative sources. the agency for healthcare quality and research has developed a useful guide for developing protocols for an altered standard of care. 42 the american health lawyers association has also developed a tool to assist states in legal preparation for a public health emergency that specifically identifies key issues involved with developing protocols for altered standards of care. 43 b. modifying liability rules for conduct during a public health emergency state statutes that provide immunity from civil liability for health care providers and workers in emergency situations can greatly facilitate the imple­ mentation of altered standards of care. while such statutes are not necessary, they clarify that health care providers will not be civilly liable for negligence in a declared public health emergency. such statutory provisions are important to provide legal "cover" in the event that stakeholders develop protocols for al­ tered standards of care that depart from the standard of care for negligence in the usual business environment. once an emergency has been declared, indiana law deems all emergency care workers, who are working in a governmental function not liable in tort for their actions, except where there is willful misconduct, gross negligence, or bad faith.44 the indiana code also provides specific immunity for both health care workers and facilities as long as they refrain from willful misconduct and gross negligence.45 furthermore, indiana law provides health care workers immunity from liability for negligence in public health emergencies if they are licensed health care professionals operating under circumstances of a declared disaster.46 these health care workers, however, are not immune from civil liability if dam­ ages result from gross negligence or willful misconduct.47 facilities are also immune from civil liability in times of declared public health emergencies.48 42. agency forheallhcare research and quality, altered standards of care in mass casualty events, (april2007), available at http://www.abrq.gov/researchlaltstandl altstand.pdf. see a/so agency for heallhcare research and quality, providing mass medical care with scarce resources: a community planning guide (feb. 2007), availa­ ble at http://www.ahrq.gov/researchlmce/. 43. am. healrnlawyersass'n, communitypan-flupreparedness:achf..ckustof key legal issues for heallhcare providers (2008), available at http://www.healthlawyers. org/content/navigationmenu/public _interest_ and_ affairs/public _information_ series/pan­ flu08.pdf. 44. ind. code§ 10-14-3-15 (2006). 45. id. § 34-30-13.5. 46. id. § 34-30-13.5-1. 47. id. § 34-30-13.5-2. 48. id. § 34-30-13.5-3. 10 indiana heal til law review [vol. 6:1 similarly, the turning point model public health act contains provisions re­ garding tort liability of health care providers and workers.49 iv. challenges the challenges for the state, the providers, and the public will be legion during a pandemic, particularly during the pandemic's surge. the surge is the point in an epidemic when the most people are infected and the demand for medical resources and services is the greatest dhhs has developed computer programs that states and providers can use to estimate the demand for services and resources during the surge. 50 also, hospitals customarily estimate what their surge capacity is for any public health emergency.s1 hospitals, nursing homes, home health care services, and other health care institutions are ill-prepared for a surge at any level, much less in the numbers expected in the event of pandemic influenza. although many hospitals could operate at 125% percent capacity or more for up to 72 hours, most cannot main­ tain this level of service beyond 3 days. s2 an additional important issue is whether alternative sites, such as hotels, schools, offices, and churches, will be used for the delivery of care during the surge and at other times. s3 such unor­ thodox facilities probably could not provide services at the customary standard of care. a. triage methodologies triage in a public health emergency is the process by which first respond­ ers will sort victims to determine priority for treatment with those whose condi­ tions will likely result in survival accorded medical care ahead of those unlikely to survive despite treatment and those who will survive regardless.s4 this deci­ sion-making process will inevitably implicate legal doctrines pertaining to the standard of care. ss in the united states, health care and health law have tradi­ tionally focused on the individual patient generally, a physician owes a duty 49. turningpointmodelstatepubuchea.lmacr§6-105(b)(2002),supranote41; see also model state public ileal til emergency powers act§ 804 (b) (2001 ), supra note 41. 50. ctr. for disease control, pandemic influenza resources, flu surge 2.0, http://www. cdc.gov/flultools/flusurge/ (last visited june 17, 2008). 51. see j. lee jenkins, robert e. o'connor, and david c. cone, medicine differentiat­ ing large-scale surge versus daily surge, 13 acad. emerg. med. 1169 (2006). 52. u.s. dep't. of ileal til &human servs., agbncyforiiealthcareresearchand qualily, ahrq pub. no. 06-0029, reopening shuti'erbd hospitals to expand surge capacity d-47 (2006), available at http://www.ahrq.gov/research/shutteredlshuthosp.htm. 53. id. 54. george p. smith, ii, re-shaping the common good in times of public health emer­ gencies: validating medical triage, 18 annals hea.lm l. 1, 9 (2009). 55. see james g. hodge, jr., legal triage during public health emergencies and disas­ ters, 58 admin. l. rev. 627 (2006). 2009] care providers in the pandemic influenza 11 to provide the best care and seek the best outcome for each patient regardless of who is in the waiting room. failure to provide such care may subject the practi­ tioner to malpractice liability, professional penalties, and/or, in the most egre­ gious cases, criminal sanctions. 56 however, in the event of pandemic influenza and an unusually large number of ill patients, physicians will necessarily focus on maximizing population outcomes rather than improving the health of indi­ viduals. 57 the medical community will shift to a public health orientation that focuses on ensuring the health and safety of the population as a whole. 58 sig­ nificantly, the goal of providing optimal care to the population may require compromising best practices or providing less than optimal care to individual patients. this approach, ethically intolerable or legally suspect under normal conditions, may be necessary and appropriate under disaster scenarios. 59 con­ sequently, pre-pandemic development of protocols for appropriate triage processes is essential. protocols must address issues such as who gets access to limited resources like ventilators versus less intensive or palliative care. yet a 2006 literature review by a canadian team of researchers found no current triage protocols for critical care in an influenza pandemic. 60 the cana­ dian team and others have since proposed triage protocols that differ in many respects but offer policymakers a starting point for pre-pandemic planning. 61 the proposals outline inclusion and exclusion criteria and identify the levels of treatment that are appropriate based thereon. most focus on symptoms and avoid subjective criteria like age and lifestyle. these tools will assist first res­ ponders in making difficult decisions that allow for the optimal allocation of limited resources. experts agree that successful implementation of a triage methodolo~ re­ quires public discussion prior to the onset of a public health emergency. a 56. see supra note 8, and accompanying text; see also ernest b. abbott, law, federalism, the constitution, and control of pandemic flu, 9 asian-pac. l. & pol'y j. 18,207-08 (2008). 57. kristi i. koenig, et al., surging to the right standard of care, 13 acad. emera. med. 195 (2007). 58. elizabeth weeks, lessons from katrina: response, recovery and the public health infrastructure, 10 depaulj. healtiicarel. 251,257 (2007). 59. id. at 284; see also hillary r able, symposium: shaping a new direction in law and medicine: an international debate on culture, disaster, biotechnology and public health: anticipating pandemic avian influenza: why the federal and state preparedness plans are for the birds, 10 depaul j. heal til carel. 213, 248-249 (2007). 60. michael d. christian, et al., development of a triage protocol for critical care during an influenza pandemic, 175 cmaj 1377 (2006). 61. id. see tia powell et al., allocation of ventilators in a public health disaster, 2 disaster med. & pub. heal til preparedness 20 (2008); daniel talmor et al., simple triage scoring system predicting death and the need for critical care resources during epidemics, 35 crit. care med. 1251 (2007); kristy challen et al., physiological-social score (pmews) vs. curb-65 to triage pandemic influenza: a comparative evaluation study using communi­ ty-acquired pneumonia as a proxy, 7 bmc healtii servs. research 33 (2007). see also, john l. hick and daniel o'langbjin, concept of operations for triage of mechanical ventila­ tion in an epidemic, 13 acad. emer med. 223 (2006). 62. see able, supra note 59, at 248-249. 12 indiana healm law review [vol. 6:1 public that is aware of and has the opportunity to participate in a forum address­ ing these very difficult issues will be less likely to view the decisions as unfair or motivated by suspected partiality. although frightening to many people, the responsible path is to reach a public consensus on triage well before the state is confronted with a public health disaster. further, pre-epidemic planning will not only allow for discussion of the tort liability issues but will also allow for standards of care to be established in criminal law and anti-discrimination law. specifically, criminal statutes and also the common law torts of reckless and intentional conduct will apply in cas­ es in which decisions about access to life-saving treatment is withheld. 63 of note, if people perceive that additional criteria-such as social utility of individuals have been used in triage decisions-health care providers may be liable for discrimination under federal and state civil rights laws. 64 federal and state civil rights laws prohibit discrimination in public accommodations and access to government programs on the basis of race, religion, gender, and national origin. 65 b. standard of care for the distribution of vaccines and antivirals as with any other health care service, the decision to allocate vaccines and antiviral medications are governed by tort and regulatory standards of care. 66 thus, attention should be given to what are the appropriate protocols for the distribution of these products during pandemic influenza as part of the broader inquiry on altered standards of care. as a legal matter, the federal government has the nearly exclusive authori­ ty to regulate drugs, biologics, and medical devices and does so through the food, drug and cosmetic act ("fdca"). 67 in national planning for pandemic influenza, the federal government, through its various emergency planning doc­ uments, has recognized a predominant federal role for the distribution of vac­ cines and biologics. 68 furthermore, federal law also addresses tort liability for injuries associated with pharmaceutical products including vaccines and medical devices. 69 in re63. see supra notes 8-19 and accompanying text. 64. see prohibition against discrimination or segregation in places ofpublic accommo­ dation, 42 u .s.c. § 2000a( a) (1999)(americans with disabilities act, title iii requiring equal access to public places); 15 am.jur.2d civil rights§ 223-231 (2000) (describing state civil rights laws). 65. id 66. see supra notes 1-29 and accompanying text 67. 21 u.s.c. §§ 331 (2009). 68. see u.s. dfp'theallli&humanser.vs..hhspandemicinfl.ltfnzaimplemjnrationpian (nov. 2006), available at hup:/lwww.hhs.govlpandemicftulimlemeotationplan.; see also u.s. dfp't heal111 & human servs., federal planning & response activities, hup:/lwww.pandemicflu.gov/ plao/federal/'mdex.html#implemmtalion (last visited mar. 11, 2009). 69. see joseph nicosia iii, note, avian flu: the consumer costs ofpreparingfor global pandemic, 18 loy. consumer l. rev. 479, 494 (2006). 2009] care providers in tile pandemic influenza 13 cent years, there have been several cases before the united states supreme court that have addressed whether federal regulatory law on labeling preempts state tort liability based on a failure to adequately warn of dangers associated with a medical product.70 in 2006, the food and drug administration ("fda") asserted via drug labeling regulation that the fdca preempted state tort law when it came to product labeling. 71 the federal turning point model state public health act, if enacted, would immunize those administering vac­ cines from civil and criminal liability in a public health emergency.n c. workforce management and altered standards of care rampant absenteeism among health professionals during pandemic in­ fluenza could result in under-staffing to such an extent that ordinary legal stan­ dards of medical care will not be met. as an altered standard of care is developed, the issue of absenteeism during pandemic influenza should be ad­ dressed. in addition, a discussion of the appropriate use of volunteer health professionals during pandemic influenza and the creation of standards may help ensure a legal environment that will not discourage their much-needed assis­ tance. 1. absenteeism of employed health care workers the federal government has estimated that pandemic influenza could af­ fect 40% of the total workforce at its peak; that rate of absenteeism during a pandemic may well be immobilizing. 73 potential reasons for employee absen­ teeism during pandemic influenza include illness or death, mandatory or volun­ tary isolation or quarantine, necessary care of children when schools have been closed, an inability to get to work due to halted public transportation, obliga­ tions to care for a sick family member, or a fear of either contracting or spread­ ing influenza at the workplace. 74 in a 2006 survey of the u.s. population conducted by the harvard school of public health, 57% of americans said they would cooperate with public health officials if instructed to stay home from work, and 35% said they would 70. see buckman co. v. plaintiffs' legal committee, 531 u.s. 341 (2001); warner­ lambertv. kent.128 s.ct.l168, 170l.ed.2d512008qff'dpercuriam;desianov. warner­ lambert & co., 467 f .3d 85 (2d cir. 2006); riegel v. medtronic, inc., 128 s.ct. 999 (2008); levine v. wyeth, 944 a.2d 179 (vt. 2006), cert. granted, 128 s.ct. 1118 (2008); co1acicco v. apotex inc., 521 f.3d 253 (3rd cir. 2008). 71. final rule, requirements on content and format oflabeling for human prescription drug and biological products, 71 fed. reg. 3922 (jan. 24, 2006)(21 cfr parts 201, 314, and 601). 72. turning pointmodelstatepubuchbaltii act§ 6-105, supra note 41. 73. u.s.dep'ttoflabor, 0ccupational8afetyandhealtiiadmin.,guidancbon preparing workplaces for an influenza pandemic 7 (2007), available at http://www.osha.gov/publications/intluenza_pandemic.h1ml. 74. id 14 indiana health law review [vol. 6:1 not. 75 also, this survey reported that 22% of employed adults expressed con­ cern that their employer would require them to work even if they were sick. 76 more recently, in 2002, a national survey of physicians found that only 55% of respondents believed that they had an obligation to care for patients in an epi­ demic during which their own health might be endangered.77 such fears of health professionals are not unfounded. in the 2003 sars epidemic, health professionals were disproportionately infected with sars in vietnam, hong kong, and canada. 78 many strategies have been proposed and/or implemented in response to this threat ofhealth professional absenteeism. the american medical associa­ tion ("ama") has adopted several new policies focusing on physician respon­ sibilities during such emergency situations.79 one ama policy, adopted in june 2004, states that "physicians have an obligation to provide urgent medical care during disasters ... even in the face of greater than usual risks to their own safety, health or life. "80 this responsibility is limited, however, by the recogni­ tion that ''the physician workforce ... is not an unlimited resource ... [and] physicians should balance immediate benefits to individual patients with ability to care for patients in the future.'.s1 different methods are being utilized to attempt to address this issue. in maryland, for example, health professionals are required to report to work dur­ ing medical emergencies or risk imprisonment. 82 the model state emergency health powers act authorizes licensure revocation by requiring that health pro­ fessionals provide care during a public health emergency "as a condition of li­ censure, authorization, or the ability to continue to function as a health care provider."83 another approach is to offer incentives discouraging absenteeism. in vietnam and canada, for example, health care workers received additional pay for caring for sars patients. 84 75. press release, harvard school of public health, in the case of an outbreak of pan­ demic flu: large majority of americans willing to make major changes in their lives, (oct. 26,2006), available at http://www.hsph.barvard.edu/newslpress-releases/2006-releases/ press i 0262006.html. 76. /d. 77. g. caleb alexander and matthew k. wynia, ready and willing? physicians' sense of preparedness for bioterrorism., 22 healthaff. 189, 195 (2003); see also ariel r. swartz, doubtful duty: physicians' legal duty to treat during an epidemic, 60 stan. l. rev. 657 (2007). 78. mark a. rothstein, are traditional public health strategies consistent with contem­ porary american values? 77 temp. l. rev. 1775, 185-86 (2004). 79. am. med. assoc., opinion 9.067: physlcian 0bugation in disaster preparedness & response (2004), available at http:llwww.ama-assn.ojwama/pub/physician­ resources/medical-ethics/code-medical-ethics/opinion9067.shtml 80. /d. 81. id 82. univ. of md. ctr.. for health & homeland sec., maryland pubuc health emergency preparedness legalhandbook(2005), available at http://www.umaryland. edulhealthsecurity/docs/handbook%209-9-05.pd£ 83. model state emergency health powers act § 608(a), supra note 36. 84. see rothstein, supra note 78, at 186. 2009] care providers in the pandemic influenza 15 absent legislative or regulatory action at the federal and state level, there is a huge body of law regulating employment relationships that will apply in the event of pandemic influenza, just as it applies at any time. laws governing employment and worker protections include wage and hour policies, workers compensation, discrimination and other matters that are integral to the employ­ ment relationship. these laws may work together to reduce the legal complexi­ ties related to absenteeism and limit employee violations of related workplace policies. 2. use of volunteer health care professionals there are three important legal issues with the use of volunteer profes­ sionals: provider liability for volunteer conduct in the delivery of services; pro­ vider liability for injury to volunteer professionals; and the portability of out-of­ state volunteer professional licenses. these issues are analyzed extensively in an article by professor james g. hodge and colleagues. 85 following the terrorist attacks of september 11, 2001, congress autho­ rized the dhhs to fund the emergency system for advanced registration of volunteer health professionals ("esar-vhp").86 under this system, thirty­ seven jurisdictions currently have operational advance registration systems, and the remaining jurisdictions have plans to become fully operational in the fu­ ture.87 although esar-vhp may allow for the rapid identification of qualified volunteers, licensure requirements will still have to be relaxed in order for vo­ lunteers to practice. most states and territories have agreed to provide for reci­ procity of licensure between jurisdictions for healthcare professionals. 88 in addition, the emergency management assistance compact ( .. emac''}­ developed by the national emergency management associationallows for reciprocity between member jurisdictions regarding the credentialing of volun­ teers for the duration of an emergency. 89 the turning point model state public health act also has extensive provisions regarding the licensure and appoint­ ment of health care personnel during a public health emergency.90 indiana law specifically allows for volunteer workers from other jurisdictions to practice 85. james g. hodge, jr., at al., volunteer health professionals and emergencies: assess­ ing and transforming the legal environment, 3 biosecurity & bioterrorism: biodefense strategy, practice & science 216 (2005). 86. see 42 u.s.c. § 300hb-10 (2009); 42 u.s.c. § 247d-3a (2009). 87. u.s. dep't. of healtii & human servs., 0mce of tile assistant sec'y for preparedness & response, fy 2009 0n:une performance appendix, available at http://www.hbs.gov/budget/09budget/asprfy09opa.pdf. 88. james d. hodge et al., risk management in the wake of hurricanes and other disas­ ters: hospitol civil liability arising from the use of volunteer health professionals during emergencies, 10 mich. st. j. med. & law 57, 68 (2006). 89. modelintrastatemunjalaid legislation art. 6 (nat'l emergency mgtnt. assoc. 2004), available at http://www.emacweb.org/?1546. 90. turning point model state pubuc heal til act § 6-104 (d), supra note 41. 16 indiana healm law review [vol. 6:1 and authorizes the use of the indiana worker's compensation program in the event of volunteer injury. 91 in addition, the indiana code allows for mutual aid agreements, both among counties and between states.92 v. conclusion recent events, such as hurricane katrina and 9/11, have highlighted the importance and necessity of preparing for emergencies and disasters before they occur. the thoughtful preparation of altered standards of care plans prior to pandemic influenza is necessary to ensure that health care providers are empo­ wered to act in their communities' best interests. such providers will be operat­ ing under significant duress in the wake of a pandemic, and the provision of legal guidance and protection is necessary to ensure that they act rapidly to mi­ tigate the spread of infection and adequately care for the afflicted. 91. ind. code§ 10..14-3-15 (2006). 92. ld § 10..14-3-16. indiana iieaith law review volume6 2009 issue 2 articles when a spoonful of sugar doesn't help the medicine go down: informed consent, mental illness, and moral agency slaying the hydra: the history of quack medicine, the obesity epidemic and the fda's battle to regulate dietary supplements marketed as weight loss aids notes physician employee non-compete agreements on the examining table: the need to better protect erin talati katharine a. van tassel patients' and the public's interests in indiana kevin d. koons kicking the butt of secondhand smoke: why indiana should ban smoking in vehicles carrying minors jennifer l. strange the awful taste of partially hydrogenated vegetable oil: a recommendation that indiana ban trans fats from restaurants andrew j. vanlandingham more bite than bark: the legal and social consequences of microchipping individuals with alzheimer's disease elizabeth g currid symposium interdisciplinary approaches to medical nanotechnology: defining the issues april is, 2009 transcript of the live symposium kody varahramyan kyle salyers david orentlicher ralph hall emily morris eleanor kinney indiana university school of law indianapolis iupui indiana health law review volume6 edito,...;,-chief andrew j. vanlandingham executive managing editor jennifer strange executive production editors shelley hallberg j. blake hike executive business editor paige boggs executive notes editor bruce jones executive articles editors ravideol jackie landess 2009 note development editors articles editors associate editors joe bruno amanda quick matt mccoy ann speidel sarah steinhardt mary beth arnold christopher l. arrington ashley arthur beth a. barnes adam n. bolerjack brian bouggy lauren devich stephen donham rachel hebner caleb kacarab susan kindig, md matt lasher meghancox brian dunkel lizcurrid jennifer m. triplett adam dolce heidi reed members faculty advisors lawrence p. wilkins (chair) david orentlicher (chair) eleanor d. kinney robert a. katz emily morris brenda k. devries allison matters john mclaughlin marc menkveld barbara molargik anna m. ly-pham emilee s. preble melissa reynolds hilari a. sautbine marc stearns trampas a. whalin shena wheeler contessa wilson indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, pmctitioners, and students on the topics ofhealth law and policy. the scope includes bioethics, malpmctice liability, managed care, anti-trust. health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2006-07 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of 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clinical professor of l.alw and director of clinical programs. b.a., saint xavier college; j.d., university oflowa college of law. r. george wrighf, lawrence a. jegen ill professor of law. a.b., university of virginia; ph.d., indiana university; jd., indiana university school of law-indianapolis. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university ofnebraska; il.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., il.m., georgetown university law school. james f. bailey, ill, professor of l.alw emeritus and director of the l.alw library emeritus. a.b., j.d., m.a.l.s., the university of michigan. clyde harrison crockett, professor of l.alw emeritus. a.b., j.d., university of texas; il.m., university of london (the london school of economics and political science). debra a. falender, professor of l.alw emerita. a.b., mount holyoke college; j.d., indiana university school of law-indianapolis. david a. funk, professor of l.alw emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; il.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. hel..bn p. garfield, professor of l.alw emerita. b.sj., northwestern university; jd., university of colorado school of law. harold greenberg, professor of l.alw emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of l.alw emeritus. a.b., juniata college; j.d., george washington university law school. wll.liam f. harvey, carl m. gray professor of l.alw emeritus. a.b., university of missouri; j.d., il.m., georgetown university law school. w. wn.i.jam hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. henry c. karlson, professor of law. a.b., j.d., il.m., university of illinois college of law. wll.llam andrew kerr, professor of law emeritus. a.b., west university; b.s., duke university; j.d., il.m., harvard law school. wll..uam e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern dlinois university; il.b., university oflliinois college of law. kbnnbtii m. stroud, professor of law emeritus: a.b., j.d., indiana university­ bloomington. james w. torke, carl m. gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., il.m., george washington university law school. law library faculty juormford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. susan boland, head of information services. b.a., monmouth college; m.s., university of lliinois; j.d., lliinois university college of law. debra denslaw, reference librarian. b.a., franklin college; m.s., university of lliinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia. southwestern college; m.l.s., university of kentucky. wendell e. johnting, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. stevenr.miller, reference librarian. b.s., lebanon valleycollegeofpennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh. serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. klyoshiorsu,automated services and media librarian. a.a., parkland college; a.b., m.s., c.a.s., university of lliinois. indiana health law review volume6 table of contents articles when a spoonful of sugar doesn't help the medicine go down: informed consent, issue 2 mental rlness, and moral agency ................................................... erin talati 171 slaying the hydra: the history of quack medicine, the obesity epidemic and the fda's battle to regulate dietary supplements marketed as weight loss aids ........................................................ katharine a. van tassel 203 notes physician employee non-compete agreements on the examining table: the need to better protect patients' and the public's interests in indiana ....................... kevin d. koons 253 kicking the butt of secondhand smoke: why indiana should ban smoking in vehicles carrying mmors ............ .jennifer l. strange 291 the awful taste of partially hydrogenated vegetable oil: a recommendation that indiana ban trans fats from restaurants ........................ andrew j. vanlandingham 325 more bite than bark: the legal and social consequences of microchipping individuals with alzheimer's disease ................................................... elizabeth g. currid 357 symposium interdisciplinary approaches to medical nanotechnology: defining the issues april is, 2009 transcript of the live symposium ...................................... kody varahramyan 385 2009 kyle salyers david orentlicher ralph hall emily morris eleanor kinney b.e.frechm h. e. frech iii is professor ofeconomics at the university of california, santa barbara, where he is a past chairman. he is also an adjunct professor at sciences po de paris and adjunct scholar at the american enterprise institute. he has been a visiting professor at harvard and at the university of chicago and an economist in the u.s. government. he has served as a consultant or expert witness for governmental agencies and private parties. in the area of health care antitrust, for example, he testified for the physician plaintiffs in k.artel v. blue shield of massachusetts and also for the attorney general of maryland in its case against the blue cross plans ofmaryland and the district of columbia. he is north american editor of the international journal of the economics of business. he has published numerous articles and written or edited several books on many topics,. including industrial organization, health economics, insurance, energy economics, land use controls, the coase theorem and the property rights theory of the finn. his most recent book is competition and monopoly in medical care, published by the american enterprise institute. the journals in which he has published include the american economic review, journal of political economy, journal of law and economics, quarterly journal of economics, journal oflnstitutional and theoretical economics,de economist and review d'economie politique. professor frech has given lectures at numerous conferences and institutions in north america and in europe. h.e. frech specializes in industrial organization, economic theory, health economics, and political economy and holds a ph.d. in economics from the university of california los angeles. william g. hamm william g. hamm is an economics consultant with high-level experience in both business and government. an expert in banking and financial institutions, he has been the executive vice-president/chief operating officer of an aaa­ rated $50 billion bank. he has also run a $1.5 billion payment processing and customer service operation for an s&p 500 company. prior to entering the private sector, dr. hammheaded the non-partisan legislative analyst's office in california, where he earned a nationwide reputation for objectivity, expertise and, credibility on public policy issues ranging from taxation to healthcare. he also spent 8 years in the executive office.ofthe president in washington, d.c., where he headed a division of omb responsible for analyzing the programs and budgets of the department of labor, hud, the veterans administration, and numerous other federal agencies. as a consultant, dr. hamm specializes in helping courts, legislative bodies, and the public develop a better understanding of complex economic and public policy issues. he assists businesses and public agencies analyze existing and proposed government policies, develop sound policy alternatives, and communicate the results to decision-makers. he is also recognized as an effective expert witness who can clarify complex litigation issues. dr. hamm has a b.a. from dartmouth college and a ph.d. in economics from the university of michigan. he is a member of the american economics association and the american law and economics association. he is also a fellow of the national academy for public administration, a founding principal· of the council for excellence in government, a member of the california institute forcountygovernment~s governing board, and a member of freedom from hunger's board of trustees. c. paul wazzan c. paul wazzan specializes in providing financial and economic analysis in the areas of securities, options and futures, antitrust, damage analysis, health and labor economics, statistics and econometrics, and intellectual property. he holds a b.a. in economics from the university of california, berkeley and a ph.d. in finance from the university of california, los angeles. dr. wazzan has taught valuation methods at the university ofsouthem california, marshall school of business. dr. wazzan is president and ceo of wazzan & co. investment llc, a venture capital firm specializing in semiconductor, optical networking, bio­ mechanical, bio-medical and related technologies. some of the areas in which dr. wazzan has conducted substantial economic and statistical analyses include: the competitive effects of mergers and joint ventures; monopolization; price discrimination; predatory pricing; market definition; securities fraud; option valuation; class certification; commodities price manipulation (e.g., non-ferrous metal price manipulation on the comex and lme exchanges); labor economics (e.g., class certification, wage & hour, employment discrimination); and intellectual property (e.g., patent and trade­ mark infringement, theft of trade secrets). his analyses have covered a wide range of industries, including basic manufacturing (e.g., mining, oil and gas, steel, food processing and distribution); high-tech manufacturing (e.g., aircraft and avionics, semiconductors, personal computers, computer peripherals); and services (e.g., banking, metals trading, organized financial markets). dr. wazzan has published on the inipact of socially motivated shareholder activism, the influence of pension fund investment/divestment on securities prices, the effects of federal and state legislation on medical care costs and the use of statistics in labor law analyses. dr. wazzan is a member of the american finance association and the american economic association. controlling medical malpractice insurance costs-congressional act·or voter proposidon? h.e. frech ill, ph.d. william g. hamm. ph.d. c. paul wazzan, ph.d.• i. introducfion it has been generally established that reducing medical malpractice insurance costs enhances the public welfare by reducing consumer (i.e., purchasers of medical care) costs and increasing access to health services.' while many states, including: alaska, california, colorado, florida, hawaii, idaho, indiana, kansas, louisiana~ maryland, massachusetts, michigan, mississippi, missouri, montana, nevada, new mexico, north dakota, ohio, oklahoma, south dakota, texas, utah, virginia, west virginia and wisconsin, have already implemented some form of malpractice insurance cost controls, federal lawmakers are currently seeking ways to control medical malpractice insurance. costs on a nationallevel.2 for example, h.r. 4280, which was pending before the u.s. house of representatives during the 1 08th congress, provides for a $250,000 cap on non-«onomic damages: congress finds that our current civil justice system is adversely affecting patient access to health care. services, better patient care, and cost-efficient health care, in that the health care liability system is a costly and ineffective mechanism for resolving claims of health care liability and compensating injured patients, and is a deterrent to the • william g. hamm and c. paul wazzan are both at lecg, llc. h.e. frech is at the university of california, santa barbara. we thank supakom chanchaowanich for invaluable research assistance. we also thank californians allied for patient protection for financial support. corresponding author is c. paul wazzan who can be reached at pwazzan@lecg.com. 1. see, e.g., congressional budget office, economic and budget issue brief: limiting tort liability for medical malpractice (jan. 8, 2004), available at http://www.cbo.g<tv/ftpdocs/49xx/doc4968/0 1..08-medicajmalpractice.pdt; kenneth e. thorpe, the medical malpractice 'crisis': recent trends and the impact of state tort reforms, health affairs (jan. 21, 2004), qvailable at http://www.healthatrairs.org (follow quick searchauthorequals1borpe)lastvisitedapr.2,2006;andu.s.generalaccounting0ffice, medical malpractice, implications of rising premiums on access to health care, gaq-03-836 (2003). 2. determination of whether individual states have caps is based on direct review of each state's laws. for example, the code of virginia defines a cap on total damages. va. code ann.§ 8.01-581.15 (michie 2006). otber states are reviewed accordingly. 34 indiana heal til law review {vol. 3:27 sharing of information among health care professionals which impedes efforts to improve patient safety and quality of care. 3 california is often cited as a model for such reform as it was among the first to take a proactive role in addressing this issue through congressional acts and voter measure as described below. a. the medical injury compensation reform act in 197 5, the california legislature enacted the medical injury compensation reform act ("micra"). the act sought to improve californians' access to health care by stabilizing medical malpractice insurance premiums, thereby making care more affordable and encouraging doctors to continue practicing in california. after micra became law, there was great uncertainty as to whether the measure's cost-savings provisions would withstand court challenges. 4 until these challenges were resolved, insurers could not be certain that the cost of malpractice insurance would go down, so as to justify lower insurance premiums. in 1985, the california supreme court upheld the constitutionality of micra, stating: [i]n enacting micra the legislature was acting in a situation in which it had found that the rising cost of medical malpractice insurance was posing serious problems for the health care system in california, threatening to curtail the availability of medical care in some parts of the state and creating the very real possibility that many doctors would practice without insurance, leaving patients who might be injured by such doctors with the prospect of uncollectible judgments. in attempting to reduce the cost of medical malpractice insurance in micra, the legislature enacted a variety of provisions affecting doctors, insurance companies and malpractice plaintiffs. section 3333.2, like the sections involved in american bank, barme and roa, is, of course, one of the provisions which made changes in existing tort rules in an attempt to reduce the cost of medical malpractice litigation, and thereby restrain the increase in medical malpractice insurance 3. help efficient, accessible, low-cost, timely healthcare (heal til) act of 2004, h.r. 4280, i08th cong. § 2 (2004). 4. see, e.g., am. bank& trust co. v. cmty. hosp. oflosgatos-saratoga, inc., 683 p.2d 670 (cal. 1984); barme v. wood, 689 p.2d 446 (cal. 1984); roa v. lodi med. group, inc., 695 p.2d 164 (cal. 1985). 2006] controlling medical malpractice insurance costs premiums. it appears obvious that this section-by placing a ceiling of $250,000 on the recovery of noneconomic damages-is rationally related to the objective of reducing the costs of malpractice defendants and their insurers. s 35 micra made four important changes to california's medical malpractice tort system: (1) it imposed a $250,000 cap on awards for non-economic losses,6 such as pain and suffering, in medical malpractice lawsuits; (2) it allowed defendants to introduce evidence showing that the plaintiff had already received compensation for a portion ofhis or her losses; 7 (3) it authorized trial courts to require periodic payments for future damages, in lieu of lump-sum awards;8 and ( 4) it imposed limits on the contingency fees that lawyers can charge medical malpractice claimants.9 micra imposes no limits on economic or punitive damages. 10 nor does it limit the exposure ofhmos and pharmaceutical companies to awards for non-economic damages resulting from medical malpractice. b. the insurance rate reduction and reform actproposition 103 the insurance rate reduction and reform act, more popularly known as proposition 103, was passed by california voters on november 8, 1988. under the measure, insurers were required to reduce rates by at least 20% from the levels in effect on november 8, 1987.11 the measure also required any change in property and casualty insurance rates to be approved by the insurance commissioner, beginning november 8, 1989. the california insurance code indicates that insurance lines subject to proposition 103's provisions include: medical malpractice, personal automobile, dwelling fire, earthquake, homeowners, inland marine, umbrella, commercial aircraft, boiler and machinery, burglary and theft, business owners, farm owners, some fidelity, fire, glass, miscellaneous, multi-peril, other liability, professional liability, special multi-peril, and coverage under the united states longshore and harbor workers' compensation act. 12 5. fein v. permanente med. group, 695 p.2d 665, 680 (call985). 6. the law defines non-economic losses as ''pain, suffering, inconvenience, physical impairment, disfigurement and other non-pecuniary damage." cal. civ. code § 3333.2(a) (2006). 7. cal. civ. code§ 3333.1 (west 2006). 8. cal.civ. code§ 667.7 (west2006). 9. cal. bus. & prof. code§ 6146 (west 2006). i 0. nicholas m. pace, daniela golinelli & laura zakaras, capping non-economic awards in medical malpractice trials: california jury verdicts under micra, rand institute of civil justice (rand corp. 2004). there is some evidence (post-cap) that non­ economic awards represent approximately 42% of total awards. 11. proposition 103, cal. ins. code § 1861.01 (a) (west 2006). 12. longshore and harbor workers' compensation act, 33 u.s.c. § 901 (2006). 36 · indianahealmlawrevmw [vol. 3:27 c. summary of findings as a result of the relatively simultaneous implementation ofproposition 103 and micra, there is some confusion as to which of these legal reforms is respo~ible for controlling the cost of medical malpractice insurance, and which would best serve as a model for federal reform.13 in an effort to assist policymakers, opinion leaders, and the public jn evaluating this argument, we examine the economic.effect of each of these laws. economic theory and empirical evidence show that proposition 103 cannot explain the relatively modest growth in malpractice premiums, in california since 1988 and that micra must be given credit for controlling these costs. · ll. pr.oposmon 103's impacfontiiecostsof -medical malpracfice insurance we first test the hypothesis that proposition 103 is responsible for the relative stability of medical malpractice insurance rates by comparing the trends in premiums for all lines of insurance subject·to the proposition's provisions. if proposition 103 is primarily responsible for holding down malpractice insurance premiums, we should observe the same favorable trend in premiums for homeowners insurance, automobile insl.irance, and other casualty insurance line~. a. proposition 103 's potential impact on medical malpractice insurance . premiums is limited ex-ante, it is theoretically unlikely that proposition 103 could be effective in limiting the growth in medical malpractice insurance premiums for ·four reasons. 1. insurance costs determine insurance premiums, and proposition 103 does not qffect medical malpractice insurance costs. insurance premiums must cover the expected cost of providing coverage (including the cost of capital required by insurers to conduct business). competition ensures that premiums do not rise to levels where unneeded surpluses are generated. if unneeded surpluses are generated by a firm's rate structure, the excess often is returned to policyholders in the form of rebates 13. sett. e.g., how insurance reform lowered doctors' medical malpractice rates in california and how malpractice caps failed, foundation for taxpayer and consumer rights (mar. 7, 2003), available at http://www.consuinerwatchd.org (follow "medical malpractice" hyperlink) (last visited apr. 2, 2006). 2006] controlling mm>lcalmalpraci1ce insurance costs 37 or dividends. in the insurance business, costs drive premiuids-ilot the ~er way around. proposition 103 does not impact insurance costs; consequently, it cannot be expected to bold down premiums. 2. proposition 103 pennits rate increases when(fl!er they are justified. proposition 103 does not prohibit increases in ins~ rates; it simply requires that the increases be justified. the california idsurance eom-· missioner bas ruled that a demonstrable increase in the cost of providing insurance is sufficient tojustify a rate increase. it should be noted that, as a matter oflaw, proposition 103 cannot force insurers to operate at a loss by keeping reserves below expected. claims. moreover, the evidence shows that loss reserves maintained by california medical malpractice insurers are not significantly different ftom the reserves held by insurers in other states. as table 1 illustrates, califoniia insurers rank eighteenth out of thirty states in terms of reserve adequacy, and their reserves are within two percent of the national mean. 38 indiana health law review [vol. 3:27 table 1: 2003 ranldngs: net income; policyholder's surplus; loss reserves; underwriting income14 average of average average net of net rank average of rank of loss rank underwriting rank income max= policyholders' max= reserves max= income max= state• ($000) 30 surplus ($000) 30 (%) 30 ($000) 30 az $1,739 9 $127,250 8 69% 13 ($13,067) 18 ca2 ($5,170) 27 $119,572 9 64% 18 ($18,561) 22 co ($274) 22 $84,608 14 44% 28 ($4,564) 7 ct $345 19 $67,689 17 87% 2 ($14,993) 20 dc ($4,900) 26 $70,372 8 64% 16 ($13,899) 19 fl $1,021 15 $75,532 15 62% 22 ($7,685) 12 ga $52 20 $177,177 4 64% 17 ($25,744) 25 la ($332) 23 $14,286 27 12% 30 ($860) 4 il $2,537 8 $172,211 5 76% 9 ($58,746) 28 la $2,588 6 $62,120 18 75% 10 ($4,896) 10 ma $13,229 2 $230,000 3 78% 6 ($63,658) 29 md $1,258 14 $113,427 11 68% 14 {$25,478) 24 me ($6,364) 29 $48,407 21 63% 20 ($9,094) 14 ml $9,615 3 $170,915 6 76% 7 ($12,077) 17 mn $4,273 4 $118,158 10 80% 4 ($8,206) 13 mo ($2,159) 25 $29,145 26 61% 25 ($2,805) 6 ms $999 16 $60,244 19 83% 3 ($1(),617) 16 nc $2,553 7 $35,084 24 63% 21 $462 nj ($2,051) 24 $45,952 22 48% 27 ($15,767) 21 ny ($89,150) 30 $266,391 2 80% 5 ($153,829) 30 oh ($6,208) 28 $145,653 7 72% 12 ($25,833) 26 or $834 17 $9,756 30 61% 24 $133 2 pa $1,738 10 $106,716 12 88% ($19,290) 23 14. am best key rating guide (2004). data represents all insurance companies where medical malpractice was listed as the first line of business (i.e., majority of business generated from medical malpractice insurance). total states represented equals thirty. "state" indicates first state of business (i.e., majority of revenue generated in indicated state). the insurance companies in california include: everest indemnity insurance co.; claremont liability ins. co.; american healthcare indemnity co.; scpie companies; scpie indemnity company; doctors company ins. group; dentists insurance company; miec group; medical insurance exchange of ca.; doctors company interinsurance exchange; california healthcate ins., rrg; norcal group; norcal mutual insurance co.; professional undrw. liab.; health providers ins. recip. rrg; podiatry ins. co., america mut. co.; medamericamutual rrg inc.; underwriter for professions; ncmic group; and ncmic insurance company. 2006] controlling medical malpractice insurance costs 39 1n $1,738 10 $85,442 13 61)0.4 26 ($9,461) tx $19,154 $357,760 74% 11 ($26,660) ut $1,457 13 $36,428 23 76% 8 ($4,715) va $665 18 $10,284 28 61% 23 ($983) wa $2,909 5 $30,442 25 63% 19 ($4,675} wi $1,587 12 $54,048 20 67% 15 ($5,819) wv ($42) 21 $10,202 29 34% 29 ($71) mean ($1,545) $97,842 66% ($18,715} max $19,154 $357,760 88% $462 min ($89,150) $9,756 12% ($153,829) 3. most malpractice insurance in california is exempt from proposition 103. proposition 103 only applies to regulated medical malpractice insurance companies. it does not apply to risk retention groups or to institutions that self-insure against claims. many physicians in california are covered by a combination of risk retention groups and self-insured institutions, both public and private (e.g., med.america insurance co.). consequently, proposition 103 can have no effect on premiums charged by these groups. 4. malpractice insurance is provided by non-profit and provider­ owned firms that have no incentive to generate excess profits. given the characteristics of california's medical malpractice insurance market, one would not expect proposition 103 to have a material impact on insurance premiums. most malpractice insurance in california is written by non-profit, mutual insurance companies that have no incentive to generate excess profits. ts this type of insurer simply charges premiums that are sufficient to cover its expected losses and maintain a small surplus. to the extent that surpluses become too large, the firm can be expected to pay dividends to its customers (who are also the "owners" in the case of mutual insurance companies). 1 s. "excess profits" means revenues in excess of costs. including the market-determined cost of capital. 15 27 9 5 8 ii 3 40 indiana ~th law review [vol. 3:27 b. california medical malpractice premium rates have grown more slowly than ratesfor other proposition 103-regulated lines. if proposition 103 is effective in controlling medical malpractice premi~, it should be equally successful in limiting the premiums charged for other lines of insurance that are subject to the measure's provisions. this hypothesis is tested by. comparing the trend in premiums for medical malpractice insurance with the trend for these other insurance lines. see figure i.. figure i: cumulative premium change (by line) since the adoption of proposition 10316 ~ --------------------------------------------~ 16. data provided by national association oflnsurance commissioners, naic reports on ptofitability by line by state, 1976-2002; california data (on file with author). 2006] controujng medical malpractice insurance costs 41 as figure 1 demonstrates, following proposition 103 's effective date, medical malpractice premiums declined, while the average premium for "all lines except medical malpractice" increased. within the first three years, the decline in medical malpractice premiums amounted to more than 20%. the obvious explanation for the opposing trends shown in figure 1 is the relative changes in claim costs. medical malpractice insurance rates went down because claim costs went down. premiums for "all lines except medical malpractice" increased because claim costs increased. this inference is economically sound because if costs had not gone up, the california insurance commissioner would have refused to approve the higher rates. since proposition 103 had no effect on the cost of providing medical malpractice insurance, while micra reduced medical malpractice insurance costs-but not auto insurance or homeowners insurance costs-the premiums charged for these and other forms of coverage moved in different directions. when the period of analysis is extended to 1998, the same disparate trends in premiums are observed: medical malpractice premiums remained below the 1988 level (-1.6%), while the rates for both "all lines except medical malpractice" and "other liability'' were significantly higher than the 1988 rates (13.9% and 11.6%, respectively) notwithstanding proposition 103. since 1988, the trend in medical malpractice insurance rates has been significantly more favorable than the trend in rates for other proposition 103regulated lines. from 1988 to 2002, medical malpractice premiums increased by 19% while premiums for "all lines except medical malpractice" grew by 57% and premiums for "other liability" grew by 74%. ill. conclusion in sum, the data demonstrates that micra, rather than proposition 103, is responsible for controlling medical malpractice insurance rates and the resulting moderation in health care costs. this finding is not surprising given the fact that proposition 103, unlike micra, does nothing to limit the actual cost of providing medical malpractice insurance. nonprofit hospital billing of uninsured patients: consumer-based class actions move to state courts david l. nie• table of contents i. introduction .•..••••••.••••.....•..•••••.•.•..••....••.....•••...•..•..•..••.......•••..•.. 173 ii. a review of nonprofit hospitals as taxexempt 0rganizations ............................................................... 178 a. tax-exempt hospitals and the provision of charity care ....... l79 b. state and local interpretations of competing federal standards for tax-exemption ..................................... l82 c. state recognition of the community benefit standard ................................................................................... 183 ill. recent scrutiny from the executive and legislative branches and grassroots organizations ............................ 186 a. congressional hearings regarding the tax-exempt health sector ............................................................................ 186 b. state legislatures address the charity care practices of hospitals within their borders ........................................... 188 c. state attorneys general act on their role of supervising charitable organizations ..................................... 189 d. advocacy groups acting on behalf of uninsured patients ...... 190 iv. the consumer protection claims of the sutter health nonprofit hospital pricing class action ............... 193 a. california's consumers legal remedies act ........................... 194 b. california's unfair competition law ...................................... 196 v. the sutter health settlement ............................................... 202 vi. conclusion ................................................................................... 203 i. introduction during a visit to a local grocery store, california resident duane darr was injured after he slipped and fell.' mr. darr was subsequently transported by • j.d. candidate, 2007, indiana university school oflaw, indianapolis, indiana; b.a, 1999, depauw university, greencastle, indiana. i would like to thank leeanne coons ofk.rieg devault llp and kristen heath for their feedback and guidance in writing this note. in addi­ tion, i thank my wife, jennifer, for her unwavering support and encouragement. 1 sutter health uninsured pricing cases, j.c.c.p. no. 4388, at 13 (cal. super. ct filed 174 indiana health law review [vol. 4:173 ambulance to the emergency room of a local nonprofit hospital.2 despite lack­ ing health insurance, mr. darr underwent basic testing at the hospital which included blood tests, a hip x-ray, and even an ekg.3 his injury did not require invasive treatment so mr. darr was given a pharmaceutical and discharged to return home.4 for his short visit, however, the hospital billed mr. darr, who had no health insurance and was not enrolled in a government plan, $4,599.1 0. 5 this amount far exceeded what he could personally afford, and, what some allege is estimated to be two to four times higher than the amount private health insurance companies have negotiated on behalf oftheirparticipants.6 based on mr. darr's situation, it would appear that a nonprofit, charitable hospital was expecting a patient who can least afford the high cost of health care to pay the list price for the services the hospital provided. 7 plaintiffs across the country have brought claims on this very issue by asserting that private insurance com­ panies and governmental payors like medicare and medicaid are receiving sig­ nificant discounts for services rendered by nonprofit hospitals while uninsured patients are being billed the full list prices. for many uninsured americans, obtaining access to affordable medical services is a daunting, if not impossible, task. although many of these indi­ viduals may fmd charitable organizations to provide them with free or dis­ counted medical care, there exists a contingent of low-income uninsured patients whose trouble does not end with the medical treatment they receive. rather, what may have appeared to these patients to be a charity hospital, or one perhaps founded on religious principles, proved in actuality to provide very little charity care. stories of these patients' financial burdens, combined with allegations of nonprofit hospital surpluses, excessive hospital expenditures, and aggressive debt collection practices, have permeated the media for the last sev­ eral years. private health insurers typically negotiate discounts on behalf of their customers and medicare and medicaid enrollees benefit from government dictated prices. as a result, a segment of patients who do not benefit from ei­ ther of these subsidies fall within a coverage gap so these persons, for purposes of this note, will generally be referred to as the "uninsured." as recent litiga­ tion has alleged, these uninsured, often low-income, patients are being asked by hospitals to pay the list price, which some also allege is an inflated price, for the medical services they received. 8 jul. 22, 2005) [hereinafter complaint]. 2 !d. 3 id. at 14. 4 !d. s !d. 6 associated press, uninsured patients pay more for care, msnbc.com, june 24, 2004, http://www.msnbc.msn.com/id/5290172/. 7 complaint, supra note 1, at 14 ("plaintiffdarr was unable to pay his bill and no one from [the hospital] provided him with any information regarding payment plans, charity care or the [hospital administered charity care program].j 8 leo t. crowley, hospitals prevailing in charity care cases, n.y. l.j., dec. 28, 2004, at 3 [hereinafter crowley 1]. in reviewing the patients' claims made in the nonprofit liti2007] nonprofit hospitals & uninsured patients 175 many hospitals have not adopted, nor are they required by law to adopt, a standard policy or method for providing charity care, in the sense of :free or dis­ counted medical services. 9 any policies on charity care that exist tend to be developed internally by a hospital and can be a complicated consideration of multiple factors that include, but are not limited to, the applicant's personal, family, medical, and financial history to determine a patient's eligibility.10 even so, some uninsured patients never have an opportunity to receive the char­ ity care for which they may qualify because information regarding the hospi­ tal's charity care options is never delivered to the patient or is otherwise presented in a confusing manner.11 in addition to the complexities of adminis­ tering hospital billing, patients in need of emergency medical attention often lack the incentive or time, at least during their medical crisis, to research and make crucial decisions about the costs of the services they are about to receive. nevertheless, some hospitals contend that individuals have a responsibility to research the financial costs of their impending treatment as well as their pay­ ment options. the reality, however, is that most patients never bother pursuing the charity care policies for which they may qualify.12 hospitals further posit that they are victims "of unions that have spread misinformation to embarrass the hospital industry, and of a society that has made impossible demands of fi­ nancially beleaguered health care providers. "13 regardless of the reasons for the problems associated with the charity care practices in the united states, multiple lawsuits have been filed, starting in 2004, against nonprofit hospitals in several federal courts alleging unlawful hospital billing practices for medical services rendered to the uninsured.14 re­ nowned mississippi plaintiffs' attorney richard scruggs15 coordinated the inigation discussed in this note, the focus of this note is on those patients who lack health insur­ ance and are not benefiting ftom managed care rates or government programs subsidizing their health care. 9 guy boulton, wisconsin to file complaints against hospitals, milwaukee j. sentinel, nov. 8, 2005, at dl. 10 !d. 11 id 12 id 13 jonathan cohn, uncharitable?, n.y. 'dmes, dec. 19,2004, § 6 (magazine), at 51, 52. 14 crowley i, supra note 8. although not discussed in this note, similar lawsuits were filed in 2004 against for-profit hospitals alleging they made millions of dollars by charging un­ insured patients inflated prices. 15 frontline online, inside the tobacco deal: interviews: richard scruggs, http://www. pbs.orglwgbhlpageslftontline/shows/settlement/interviews/scruggs.html (last visited mar. 4, 2007). mr. scruggs was very successful pursuing large class action cases against the asbestos industry. /d. mr. scruggs then took on the tobacco industry in the 1990s in which his relation­ ships with long-time-mend mississippi attorney general mike moore and brother-in-law sen­ ate majority leader trent lott, likely helped to facilitate the anti-tobacco litigation. id the tobacco suits yielded over a $200 billion settlement to be paid out to the states for health-related damages. id. mr. scruggs's role in the litigation was later featured in the 1999 film, "the in­ sider." mr. lott currently sits on the u.s. senate committee on finance, which, since 2005, has been reviewing the charity care practices of the nonprofit hospital industry. see u.s. s. comm. 176 indiana health law review [vol. 4:173 tial class action suits which have been followed by a growing list of derivative cases around the country brought under similar theories. at last count, there were over seventy suits filed in various federal courts alleging unfair hospital pricing of the uninsured. 16 the complaints centered around a variety of similar theories, including federal law governing tax-exempt organizations, federal law governing emergency care, state law governing charities, and state contract and tort principles.17 the federal claims in the overwhelming majority of these cases consistently have been dismissed with prejudice. 18 with the exception of a few federal courts, 19 most of these courts have dismissed the state claims without prejudice. many of these suits have since been, or soon will be, refiled in state courts in pursuit of the remaining state claims.20 in at least thirteen state courts where the plaintiffs have re:filed, the judges have denied the hospitals' initial attempts to have these cases dismissed.21 thus, this litigation currently appears to be most promising for those plaintiffs pursuing it at the state level because state courts are apparently willing to acknowledge the causes of action on the remaining state law theories. the issues surrounding accessible health care are numerous and deserving of attention. this litigation concerning hospital pricing of services provided to uninsured patients is noteworthy because it attempts to alter the charity care practices of nonprofit hospitals through consumer-based class action litigation in state courts. 22 it may be unreasonable to expect nonprofit hospitals to pro­ vide free or discounted health care to every person lacking health insurance by voluntarily overhauling their respective charity care practices and policies; however, by drawing attention to the ongoing plight of the indigent, uninsured, and underinsured, this litigation could pressure nonprofit hospitals, as well as on fin., comm. members, http://finance.senate.gov/sitepages/committee.htm (last visited mar. 4, 2007). 16 nonprofit hospital charity care litigation, health l. rep., nov. 22, 2004, http://healthcenter.bna.comlpic2/hc.nsf7id/bnap-674mlv (providing a detailed list of over seventy cases filed across the country); see also hospital watch, hospital watch update, http://www.hospitalpricegouging.orglmain.html (last visited mar. 4, 2007) (providing court and settlement documents, as well as press releases regarding the nonprofit and for-profit hospital litigation). 17 crowley i, supra note 8. 18 press release, richard scruggs, statement ftom dick scruggs nonprofit hospital litigation status (oct. 2005), available at http://www.cliffordlaw.comlnot-for-profit-hospital­ class-action-litigationlpress-releases/statement-ftom.dick-scruggs-nonprofit-hospital-litigation­ status [hereinafter statement from scruggs]. 19 see both kolari v. n.y.-presbyterian hosp., 382 f. supp. 2d 562, 579 (s.d.n.y. 2005) and bobo v. christus health, 227 f .r.d. 479, 483 (b.d. tex. 2005), where the defendant hospitals' motions to dismiss the state claims were granted with prejudice. 20 william mccall, hospital settles class-action claim by uninsured, albany democrat-iierald, nov. 3, 2005, at a7. 21 statement from scruggs, supra note 18. 22 lisa w. clark et al., what may arrive in tomotrow's mail?: an analysis of class action lawsuits concerning hospital billing of uninsured patients, 13health l. rep. 1134, 1135 (2004). 2007] nonprofit hospitals & uninsured patients 177 legislators and the general public, to ask whether the hospitals are at least doing their financial part. this litigation could provoke change within an area of health care where state and federal legislatures, for-profit and nonprofit hospi­ tals, and health insurance providers have failed in their attempts to find ade­ quate remedies for the provision of discounted or affordable health care to all persons. some hospital systems have already begun to act either in response to settlement agreements reached in their own litigation or simply in response to the negative attention surrounding these suits. although most courts have indi­ cated that the issue of nonprofit hospital pricing is more appropriate for the state legislatures to address, state consumer protection laws could be the means that brings this issue to a head in a state court. when in need of medical care, uninsured patients are likely to look to nonprofit hospitals for medical attention because of mission statements, reli­ gious affiliations, and advertising materials that indicate helping the sick, poor, and uninsured are part of the hospital's core goals. consequently, low-income uninsured persons are surprised when they are billed for medical services at what appear to be radically inflated rates. although there are patients who jack health insurance, but can afford to pay the hospital bills, there are also patients who are without health insurance and lack the financial resources to pay the hospitals back. on the one hand, it is difficult to contest the price of saving a life. but if uninsured persons are expected to pay the full amount for the medi­ cal services they received then the resulting debt can be a real life financial nightmare. whether nonprofit hospitals are to blame for not doing enough in the provision of charity care services or the patients are to blame for their own misunderstandings regarding the costs of the care they receive, the focus of this note is on the state consumer protection laws upon which the plaintiffs are bas­ ing their claims and which could prove to be a catalyst for reform in the way hospitals administer and subsequently bill for medical services rendered to the uninsured. the plaintiffs in the nonprofit hospital pricing litigation have generally al­ leged that the defendant hospitals have a duty to operate exclusively for a chari­ table purpose because they were granted tax-exempt status under state and federal law. therefore, in part ti, this note will discuss the history of nonprofit hospitals and their tax-exempt status. in part lll, this note will explore there­ cent scrutiny these hospitals are under and identify the interesting connections that exist among the ongoing litigation in state courts, recent initiatives at the legislative and executive levels of government, and the impact some powerful nonprofit organizations have had in advocating for the uninsured. finally, in part iv, this note will examine the california consumer protection laws serving as the basis for the claims made in a class action against california's sutter health network, 23 which is one of the suits that was refiled in a california state 23 complaint, supra note 1; see also sutter corporate watch, what is sutter health?, http://www.suttercorporatewatch.com/aboutsutter.php (last visited mar. 7, 2007). 178 indiana heal til law review [vol. 4:173 court and showed particular promise for the plaintiffs that it would go to trial. the california class action implicates sutter health which is a private, nonprofit corporation that owns and operates twenty-six hospitals in northern california. the uninsured plaintiffs first brought suit in 2004 in the united states district court of the northern district of california. 24 the district court ultimately granted sutter health's motion to dismiss the patients' federal claims but dismissed the patients' state law claims without prejudice to refiling in state court after declining to exercise supplemental jurisdiction over the state law claims. in july 2005, the plaintiffs refiled in the superior court of the state of california, county of sacramento; however, in late 2006 the parties reached a settlement.25 despite the settlement, the california state law claims are worthy of review for at least two reasons. first, the superior court denied sutter health's initial motions to dismiss and, second, because sutter health counter­ sued members of the class. these actions had the combined effect of indicating that this case might actually go to trial. thus, a review of the two california consumer protection laws that make up two of the five causes of action26 brought by the plaintiffs may prove relevant to hospital pricing cases brought in other states under similar theories. the plaintiffs in these hospital pricing cases generally allege that nonprofit hospitals have acted unlawfully, unfairly, or even fraudulently in their business with uninsured patients despite the charitable purposes for which they are supposed to operate in exchange for their tax­ exempt status. consequently, these suits have fueled the national debate re­ garding charity health care practices in the united states. it. a review of nonprofit hospitals as tax-exempt organizations in the last several years, new attention has been given to the governance of nonprofit hospitals and to the way in which they are meeting their tax­ exempt obligations. 27 there are several potential reasons for this focus, includ­ ing, "financial and management scandals in both the for-profit and nonprofit sectors, the increased need for charity care in the wake of governmental cut­ backs, and the changing economics ofhealth care in general.'.28 in effect; this attention has pressured nonprofit hospitals to examine their levels of disclosure, their methods of corporate governance, and their existing billing and debt col24 darr v. sutter health, no. c 04-02624 wha, 2004 u.s. dist lexis 24592 (n.d. cal. nov. 30, 2004). 25 sutter health uninsured pricing cases, j.c.c.p. no. 4388 (cal. super. ct. dec. 12, 2006) (final order and judgment). 26 complaint, supra note l, at 17-24. the three non-statutory based causes of action were unjust enrichment, breach of contract, and breach of duty of good faith and fair dealing. 27 thomasl.greaney,newgovernancenormsandqualityofcareinnonprofithospi­ tals, 14 ann. health l. 421, 423 (2005). 28 /d. 2007] nonprofit hospitals & uninsured patients 179 lection practices. 29 the public's expectations, statutory requirements, and judi­ cial treatment of tax-exempt hospitals have evolved over time and vary from state to state. thus, a national debate exists regarding the charity care practices of nonprofit hospitals and whether those practices are sufficient to satisfy the tax-exempt obligations and corresponding benefits the hospitals receive. a. tax-exempt hospitals and the provision of charity care in order for an organization to be tax-exempt, it must be organized and operated exclusively for the purposes set forth in§ 501(c)(3) of the internal revenue code. 30 organizations meeting these requirements are commonly re­ ferred to as charitable organizations but also are considered "nonprofit" or "not­ for-profit." the term "nonprofit" can be misleading because its meaning does not preclude an organization from earning a profit.31 in order for an organiza­ tion to be tax-exempt under the law, it is not sufficient that the organization be simply structured as a nonprofit entity, but rather it must meet specific federal statutory and regulatory requirements.32 if the hospital qualifies for tax­ exemption, then it is presumptively expected to meet certain standards in order for it to maintain that exemption; however, those standards are not always so easily interpreted and can be the source of confusion and controversy when the hospital is asked to justify its tax benefits. according to the internal revenue service ("irs"), the term "charitable" as used to describe a§ 501(c)(3) organization has come to mean an organiza­ tion that provides for the ''relief of the poor, the distressed, or the underprivi­ leged; advancement of religion; [and] lessening the burdens of government.'.j3 most individuals might associate "charity" or "charitable" as an activity or or­ ganization that benefits the poor or underprivileged members of society. these terms, however, have proved to be a gray area for courts when faced with de­ ciding whether a nonprofit hospital is meeting its charitable obligations under§ 501(c)(3). specifically, the confluence of the irs and common law interpreta­ tions of the word "charity" has evolved into the present day definition that ap­ plies to nonprofit hospitals. 29 see id. at 423-28. 30 26 u.s.c. § 501(cx3) (2000) ("corporations, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes. ... no part of the net earnings of which inures to the benefit of any private shareholder or individual, no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation (except as otherwise provided in subsection (h)), and which does not participate in, or intervene in (including the publishing or distributing of statements), any political campaign on behalf of (or in opposition to) any candidate for public office. j. 31 brucerhopkins,650essentialnonprofitlawquestionsanswered 1 (2005). 32 !d. at40. 33 internal revenue serv., u.s. dep't of the treasury, exemption requirements, http://www.irs.gov/charities/charitablelarticle/o,,id=96099,00.html (last visited mar. 7, 2007). 180 indiana healtii law review the general usage of the word charity means "relief of the poor." the word "charitable" can also be traced back through common law to mean "any function promoting the general welfare of society." initially~ the irs sub­ scribed to the "relief of the poor" interpretation [or char­ ity care standard] .... when hospitals started serving the entire community instead of limiting themselves to the indigent, a significant source of their revenue came from paying patients. thus, if nonprofit hospitals were going to retain their tax-exempt status, "charitable" needed to be redefined. consequently, the common law meaning of charitable [any function promoting the gen­ eral welfare of society] began to apply to the tax code. 34 [vol. 4:173 thus, for purposes of federal tax-exemption as it applied to nonprofit hos­ pitals, the meaning of" charitable" evolved from a connotation that the hospital had to provide "relief of the poor" to a legally acceptable standard that consid­ ered the general "promotion of health" to the community as sufficient justifica­ tion for exemption. the competing standards are generally referred to as the "charity care standard" and the "community benefit standard. "35 the charity care standard initially adopted by the irs was first evident in a 1956 revenue ruling which found that in order to qualify for tax-exemption, a hospital "must be operated to the extent of its financial ability for those not able to pay for the services rendered and not exclusively for those who are able and expected to pay."36 thus, serving the poor became a prerequisite for exemption. this in­ terpretation lasted until nonprofit hospitals started serving the entire community which led the irs to adopt broader interpretations of the word charitable. this relaxing of requirements was confirmed with revenue ruling 69545.37 the standard changed to one that considered the benefit a hospital pro34 jack burns, note, are nonprofit hospitals really charitable?: taking the question to the state and local level, 29 j. corp. l. 665, 667 & n.25, 668 (2004) (quoting a. kay b. roska, comment, nonprofit hospitals: the relationship between charitable tax-exemptions and medical care for indigents, 43 sw. l.j. 759, 763-65 (1989)); see also jack e. karns, justi­ fying the nonprofit hospital tax-exemption in a competitive market environment, l3 widener l.j. 383, 523 (2004). although § 501 ( c x3) does not specifically mention "hospital" or ''health care," hospitals have generally proposed two justifications for the federal tax-exemptions they receive. id first, hospitals assert that the health care services they provide have ''traditionally been included implicitly with those services that are listed in the federal exemption statute." id second, they point to irs administratively institutionalized exemptions, which are created by revenue rulings and have been used to justify the nonprofit hospital exemption. id. 35 see generally burns, supra note 34, at 676-78. 36 rev. rut. 56-185, 1956-1 c.b. 202; see generally bums, supra note 34, at 667-68. 37 rev. rul. 69-545,1969-2 c.b. 117,117-19(adoptingthecommunitybenefitstandard over the charity care standard). the ruling held in relevant part, "[t]he promotion ofhealth, like the relief of poverty and the advancement of education and religion, is one of the pwposes in the 2007] nonprofit hospitals & uninsured patients 181 vides to the community as a whole even though the hospital may not provide direct benefits to indigent community members.38 while this ruling confirmed a shift of interpretations in the tax code, it likely had little effect in changing the average consumer's perceptions of the word "charity," 39 which arguably are more consistent with a "relief of the poor" interpretation rather than the com­ munity benefit standard adopted by the irs. nevertheless, the irs offered with revenue ruling 69-545 factors to assist in the assessment of a nonprofit hospi­ tal's tax-exempt status.40 when the provision of charity care was dropped from a hospital's tax-exemption requirements, hospitals were granted greater flexibil­ ity to develop charity care policies and procedures that would best fit within their business plans while also ensuring the retention of their tax-exempt status. despite the federal shift in tax-exempt standards from a charity care ap­ proach to a community benefit assessment, issues still arise when it comes to determining whether a hospital is in fact providing an appropriate level ofbene­ fit to the community to justify its tax-exempt status.41 for example, proponents of the charity care standard prefer a system where "for every dollar of taxes for­ gone, the public get a 1 000/o return in the form of free hospital services" on the premise that the flexibility of the community benefit standard is not sufficiently quantifiable to justify tax-exemptions.42 without the strict guidelines of a char­ ity care standard, some propose that the nonprofit sector has "created opportugeneral law of charity that is deemed beneficial to the community as a whole even though the class of beneficiaries eligible to receive a direct benefit from its activities does not include all members of the community, such as indigent members of the community, provided that the class is not so small that its relief is not ofbenefit to the community." ld. 38 rev.rul.69-545,1969-2c.b.117, 118. seealsohelenao.rubenstein,nonprofit hospitals and the federal tax-exemption: a fresh prescription, 7 heal1hmatrix 381,397 (1997); bums, supra note 34, at 668 & n.37. 39 webster's third new international dictionary 378 (3d ed. 1961) ("an organiza­ tion or institution engaged in the free assistance of the poor, the suffering, or the distress; public provision for the care or relief of the needy"). 40 burns, supra note 34, at668-69 (citing rev. rul. 69-545, 1969-2 c.b. 117). these factors as appearing in the ruling include, "(i) whether a board of trustees control the hospital and, if so, whether civic leaders compose the board; (2) whether the hospital has an open medi­ cal staff and extends privileges to all qualified physicians in the area; (3) whether the hospital operates an active and accessible emergency room, regardless of patients' ability to pay; (4) whether the hospital provides medical care to all persons able to pay; and (5) whether smplus funds, when used, improve the quality of patient care." id. according to the irs, a hospital that meets these factors is operating for a public rather than private purpose. /d. at 669. this federal shift from a requirement of charity care to an acknowledgement of general community benefits was further supported by rev. rul 83-157, 1983-2 c.b. 94, 95, which held that a nonprofit hospital could still qualify for exempt status even if it had no emergency care facilities as long as the general purposes of the hospital sufficiently benefited the community. bums, supra note 34, at669. 41 burns, supra note 34, at 667. 42 id at 676 & n.14l (citing mark a. hall & john d. colombo, the charitable status of nonprofit hospitals: toward a donative theory oft ax-exemption, 66 wash. l. rev. 307,34563 (1991) (explaining the "quid pro theory" as it applies to hospitals and assessing why this charity care standard is inadequate for the exclusive basis for tax-exemption)). 182 indiana health law review [vol. 4:173 nities for [hospital] noncompliance" with even minimum community benefit standards.43 regardless of the outcome of the national debate over the compet­ ing standards, consumers without health insurance are left to assess whether the nonprofit hospital in their community will be providing them health care within the context of free or discounted care or instead within the broad parameters of the federal, community benefit definition. b. state and local interpretations ofcompeting federal standards for tax-exemption when nonprofit hospitals benefit from their tax-exempt status, many states and local governments bear a corresponding burden in the form of lost revenue.44 a nonprofit corporation is not automatically exempt from federal and state taxes. before a hospital can receive federal tax-exempt status, it must first apply for nonprofit incorporation at the state level. once incorporated as a nonprofit, the hospital can apply to the irs for federal tax-exemption. if granted exemption from federal income taxes, then states vary on their exemp­ tion requirements: "some states require a separate application to get a state tax­ exemption; some states are satisfied with your federal tax-exempt status; and in others, [the hospital] will need to send a copy of[its] irs determination letter" to the appropriate state agency.4s it is to the state's advantage to develop, and hold nonprofit hospitals accountable to, minimum standards for the provision of medical care to its uninsured and indigent residents when the federal prerequi­ site for tax-exemption is the lenient community benefit standard. the federal government is less inclined to heighten the qualifications for tax-exemption because "[t]he amount of money [it] expends through medicare and medicaid programs predisposes the federal government to favor efficient, business-like hospitals" rather than entities burdened with meeting the needs of charity cases. 46 when nonprofit hospitals adopt more commercial, profit oriented poli­ cies and operations, state and local communities tend to lose charitable health services. consequently, it may be up to the states to take a more active role in the regulation of these organizations. although some state legislatures have taken proactive steps toward ensuring that nonprofit hospitals are providing an adequate amount of charity care,47 this note examines whether consumer pro­ tection laws may also serve as an impetus for reform via the judiciary. 43 ice miller llp, survey of recent developments in health law, 391nd. l. rev. 1051, 1072 (2006) (quoting the tax-exempt sector before the h. comm. on ways & means, 109th cong. 19 (2005) (statement of mark everson, commissioner, internal revenue service)). 44 burns, supra note 34, at 679. 45 joanne fritz, nonprofit incorporation-the first step to fonning a tax-exempt non­ profit, http://nonprofit.about.com/od/nonprofitbasics/a/incorporating.htm (last visited mar. 9, 2007). 46 burns, supra note 34, at 678. 47 see infra text accompanying notes 77-82. 2007] nonprofit hospitals & un1nsured patients 183 despite the federal shift to the community benefit standard,48 some state courts have rejected the irs's opinion that the provision of health care is inher­ ently charitable and instead have adopted interpretations oftheir respective state statutes that are more consistent with the charity care standard. 49 when doing so, states tend to utilize one of two approaches in considering their hospitals' tax-exempt status: the "process approach" (which is closer to the community benefit standard) in states such as california; 5° and the "prescriptive approach" (which often requires a minimum amount of charity care) in states such as pennsylvania and utah. 51 claims brought in states that have adopted the pre­ scriptive approach may be more successful because courts can more readily determine whether the hospital has quantifiably satisfied its charity care man­ dates. this does not necessarily preclude equally successful claims in states that have adopted the process approach. the basis of the claims in the non­ profit hospital pricing litigation is not a direct challenge to a hospital's tax­ exempt status. instead, the plaintiffs alleged that hospitals are misleading the public in holding themselves out to be a charitable organization operating for the benefit of the community, but are in tum overcharging those members of the community who are in the greatest need of their fair pricing. c. state recognition of the community benefit standard although the sutter health pricing case has settled, a review of the cali­ fornia laws regarding tax-exemption may help to put the plaintiffs' consumer protection claims in the appropriate context. a nonprofit corporation exempt from federal taxes must still apply for exemption from the california tax, but the state taxation laws in california are similar to the federal laws in that they generally adopt the community benefit standard. in article xiii, section 4(b) of the california constitution, nonprofit hos­ pitals are granted express exemption from real estate taxation. specifically, this section provides that the legislature may exempt from taxation in whole or in part "[p ]roperty used exclusively for religious, hospital, or charitable purposes and owned or held in trust by corporations or other entities (1) that are organ48 see supra text accompanying note 3 7. 49 bums, supra note 34, at 674-76. 50 see infra text accompanying notes 52-56. 51 leah snyder batchis, can lawsuits help the uninsured access affordable hospital care?: potential theories for uninsured patient plaintiffs, 78 temp. l. rev. 493,511 (2005). see also hosp. utilization project v. commonwealth, 487 a.2d 1306, 1317 (pa. 1985) (finding that a hospital is charitable if it meets the following five prongs: 1) advances a charitable pur­ pose, 2) donates or renders gratuitously a substantial portions of its services, 3) benefits a sub­ stantial and indefinite class of persons who are legitimate subjects of charity, 4) relieves the government of some of its burden, and 5) operates entirely free from profit motive); utah county v. intermountain health care, inc., 709 p.2d 265, 278 (utah 1985) (denying state tax­ exemption to two nonprofit hospitals because they were not operated for "charitable" purposes in accord with the state's interpretation of charity, which was a "gift to the community''). 184 indiana health law review [vol. 4:173 ized and operating for those purposes, (2) that are nonprofit, and (3) no part of whose net earnings inures to the benefit of any private shareholder or individ­ ual."52 thus, california law clearly provides the prerequisites for a hospital's tax-exempt status where federal laws do not. the california legislature added further support for a hospital's tax-exemptions in the california revenue and taxation code, 53 which provides in relevant part: property used exclusively for religious, hospital, scien­ tific, or charitable purposes owned and operated by com­ munity chests, funds, foundations, limited liability companies, or corporations organized and operated for religious, hospital, scientific, or charitable purposes is exempt from taxation, ... if: (1) the owner is not or­ ganized or operated for profit. however, in the case of hospitals, the organization shall not be deemed to be or­ ganized or operated for profit if, during the immediately preceding fiscal year, operating revenues, exclusive of gifts, endowments and grants-in-aid, did not exceed op­ erating expenses by an amount equivalent to 10 percent of those operating expenses. as used herein, operating expenses include depreciation based on cost of replace­ ment and amortization of, and interest on, indebtedness . . . . the exemption provided for herein shall be known as the "welfare exemption."54 although california has taken steps to include hospitals within its "welfare ex­ emption," not every state has been so explicit. 55 california case law has con­ firmed that the benefit a hospital provides to its community is a factor to consider in justifying tax-exemption. 56 52 cal. const. art. xiii, § 4(b) (emphasis added); see also nat'l charity league, inc. v. county oflos angeles, 330 p.2d 666 (cal. ct. app. 1958) (finding that this exemption is not a constitutional mandate, but permissive such that the legislature may extend or deny exemption to any of the organizations listed in the constitution). 53 kellen mcclendon, what the national health care debate tells us about whether hospitals are entitled to exemption from real estate taxes, 6 widener j. pub. l. 41, 45 (1996). 54 cal. rev. & tax. code§ 214(a) (west 1998) (emphasis added). 55 mcclendon, supra note 53, at46 & n.l2 (citing fla. const. art. vii,§ 3(a); mass. const. pt.2, ch.1, 1, art. iv (amended 1978); mo. const. art. x,§ 6; or. const. art. ix,§ 1; tenn. const. art. ii,§ 28; utah const. art. xiii,§ 2; fla. stat.§ 196.192 (1989); mass. gen. laws ch. 59, 5, cl. 3 (1994); mo. rev. stat.§ 137.100(5) (1988); or. rev. stat.§ 307.130 (1995); tenn. code ann.§ 67-5-212 (1994); utah code ann.§ 59-2-1101 (1996)). 56 !d. at 48 & n.l6 (citing rideout hosp. found., inc. v. county ofyuba, 10 cal. rptr. 2d 141, 143 (cal. ct. app. 1992)(holding that "[t]he rationale for the welfare exemption is that the exempt property is being used either to provide a government-like service or to accomplish 2007] nonprofit hospitals & uninsured patients 185 state court interpretations of the state tax laws regarding nonprofits vary, but some common trends are identifiable in those states where the state exemp­ tion laws are similar to the federal versions. for example, vermont granted nonprofit hospitals tax-exemption because it saw the social value and potential community benefit that can be derived from the general provision of health care. 57 the supreme court of vermont dealt with hospital exemptions in medical center hospital v. burlington58 where the plaintiff hospital sought a declaratory judgment that its property qualified for exemption under state tax laws59 after the city of burlington sent the hospital a notice of assessment and a tax bill. the hospital argued that its goal "of establishing and maintaining a public hospital and nursing home exclusively for charitable and educational purposes" was consistent with the community benefit standard for exemption.60 acknowledging the changing landscape ofhealth care facilities, as well as the change in meaning of the word "charitable,',t;1 the court decided it was the role of the legislature to grant tax-exemptions and that, accordingly, the hospital was indeed taxmexempt because it was "a not-for-profit institution with a recognized charitable purpose whose services [were) available regardless of ability to pay and whose excess revenues [were] devoted to the maintenance of its purpose .. • • " 62 although the vermont court showed deference to the legislative mandate, if consumers continue to challenge the extent to which a hospital is benefiting the community in exchange for the tax breaks it is receiving, then the judiciary may prove to be a forum for successful challenges of the nonprofits' business practices. as the debate surrounding the validity of hospital tax breaks moves to state courts, plaintiffs' attorneys will likely draw on the disparity between the rates accepted for those participants in federal programs and the rates private insurance companies negotiate compared to the list prices a nonprofit hospital bills its uninsured patients. if great disparity exists, it could serve as the prem­ ise for arguments that the nonprofit hospital is not meeting its tax-exempt obli­ gations. the more a hospital's representations are likely to mislead or deceive patients, the more difficult it will be to downplay the inadvertent deception as insignificant when compared to the community benefit derived from the hospi­ tal's services. some desired social objective")). 57 bums, supra note 34, at 676. 58 med. ctr. hosp. v. burlington, 566 a.2d 1352, 1353 (vt. 1989). 59 vt. stat. ann. tit. 32, § 3802(4) (1994) (exempting from taxation "[r]eal and per­ sonal estate granted, sequestered or used for public, pious or charitable uses .... "). 60 med. ctr. hosp., 566 a.2d at 1353. 61 !d. at 1356 (quoting share v. comm'r of revenue, 363 n.w.2d 47, 52 (minn. 1985)) ("the term 'charitable' as applied to health care facilities has been broadened since ear­ lier times, when it was limited mainly to almshouses for the poor."). 62 id at 1357; see also bums, supra note 34, at675-76 (discussing utah countyv. in­ termountain health care, inc., 709 p.2d 265 (utah 1985), hosp. utilization project v. com­ monwealth, 487 a.2d 1306 (pa. 1985), andmed. ctr. hosp. v. burlington, 566a.2d 1352 (vt. 1989), to "show that the question of granting tax-exempt status to a nonprofit hospital is a po­ litical and policy question that will be determined on a state-by-state basis.") 186 indiana health law review [vol. 4:173 iii. recent scrutiny from tile executive and legislative branches and grassroots organizations a. congressional hearings regarding the tax-exempt health sector the united states house of representatives committee on ways and means held a hearing on may 26, 2005, at which it received testimony that raised questions about what a hospital should be required to do to deserve ex­ empt status.63 during this hearing, david walker, the government account­ ability office comptroller general of the united states, summed up his testimony by stating that the current tax policy lacks specific criteria with respect to tax-exemptions for charitable entities, ... including not-for-profit hospitals, in particular. if these criteria are articulated in accordance with desired public policy goals, standards could be established that would allow not-for-profit hospitals to be held accountable for pro­ viding services that benefit the public commensurate with their tax-favored status.64 in a time of increasing health care costs, the hearing was an effort to re­ view fonner, as well as existing, standards and criteria, used to detennine whether a hospital is eligible for tax-exempt status. 65 the may 26 hearing was one of several hearings regarding the tax-exempt sector, but this one in particu­ lar focused on nonprofit hospitals qualifying for tax-exempt status.66 the chainnan of the committee explained the hearing was not an attempt to "pick on" the hospitals but was necessary because the majority of revenue in the charitable sector was going to tax-exempt hospitals.67 according to one ac­ count, nonprofit hospitals in the united states made up only 1.9 percent of the charitable organizations under§ 501(c)(3) in 2001, but received 41 percent or $337 billion in tax expenditures.68 moreover, less and less was being required 63 the tax-exempt sector before the h. comm. on ways & means, 109th cong. passim (2005) [hereinafter house hearing on tax-exempt sector]. 64 ld at20. 65 independent sector, congressional oversight: house ways and means committee holds hearing on tax-exempt hospitals, http://www.independentsector.org/programs /gr/hospital.html (last visited mar. 9, 2007) ( "[i]n a recent study of hospitals in five strategi­ cally selected states, the gao found little difference between the level of uncompensated care offered by for-profit and nonprofit hospitals.'') (paraphrasing the testimony of gao comptroller general david walker). 66 id. 67 house hearing on tax-exempt sector, supra note 63, at 4-5. 68 batchis, supra note 51, at 513 & n.161 (citing press release, subcomm. on over­ sight, h. comm. on ways & means, houghton announces first hearing in a series on tax2007] nonprofit hospitals & uninsured patients 187 of these hospitals in order to maintain their tax-exempt status. since this is where the money was, so to speak, the committee considered it within its con­ gressional responsibility to ask what it is that taxpayers are getting in return for the billions of dollars hospitals are receiving in tax subsidy. 69 although no wit­ nesses offered specific recommendations for changing the tax-exempt policies for nonprofit hospitals, witnesses did testify that legislators should proceed with caution because major policy changes bad the potential "for profound negative and unintended consequences to the sector."70 in may 2005, united states senator chuck grassley issued a letter in his role as chairman of the committee on finance to ten hospitals and hospital systems requesting responses to extensive questioning about their business practices as related to charitable activities, patient billing, and ventures with for-profit companies. 71 on september 12, 2006, the committee released a compilation of the responses it had received from the ten nonprofit hospitals grassley had written in 2005.72 the next day, the committee held a hearing during which senator grassley focused his opening statement on two issues regarding the nonprofit sector: "measurements and reporting of community benefit and also discounted charges or free care to low-income uninsured indi­ viduals.'m senator grassley commended one hospital system in particular for their development of best practices for measuring and reporting their activities within the community benefit context. 74 testimony revealed some of the chal­ lenges nonprofit hospitals face despite well-developed policies committed to providing a community benefit. 75 senator grassley acknowledged that under exemption: pricing practices of hospitals (june 15, 2004), available at http://waysand.means. house.govlhearings.asp?formmode=view&id=l673). 69 house hearing on tax-exempt sector, supra note 63, at 4. 70 independent sector, supra note 65. 71 press release, grassley.senate.gov, grassley asks non-profit hospitals to account for activities related to their tax-exempt status (may 25, 2005), available at http://grassley.senate.gov/index.cfin?fuseaction=pressreleases.detail&pressrelease _id=4921 (reprinting the text of senator grassley' s letter to the ten hospitals and hospital systems). 72 u.s. s. comm. on fin., summary of 10 non-profit hospital responses passim (2006), http://finance.senate.gov/press/gpress/2005/prg091206summary.pdf. 73 u.s. s. comm. on fin., taking the pulse of charitable care and community benefits at nonprofit hospitals, opening statement of chainnan grassley, http://finance.senate.gov/hearingslstatements/091306cg.pdf(last visited mar. 27, 2007). 74 !d. 75 u.s. s. comm. on fin., taking the pulse of charitable care and community benefits at nonprofit hospitals, testimony: sister carol keehan, http://finance.senate.gov/hearingsltestimony/2005test/091306cktest! .pdf (last visited mar. 27, 2007). sister keehan, the president and chiefexecutive officer of catholic health association of the united states, testified that some ofthe challenges facing nonprofit hospitals include, but are not limited to, the growing numbers oflow-income uninsured persons in need of medical attention, the difficulty in distinguishing patients who will not pay their health care bills from those who unable to pay, and the challenge of identifying those patients who are eligible for financial assistance. id sister keehan also stressed that "community benefit is much more than providing charity care and discounted care to low-income persons. we also have a responsibility 188 indiana health law review [vol. 4:173 the present system there is little common ground from which to develop poli­ cies or answer basic questions regarding the activities of tax-exempt hospitals. 76 b. state legislatures address the charity care practices of hospitals within their borders recognizing that state laws regarding tax-exemption are lacking in certain respects, some state legislatures have enacted laws that set more specific stan­ dards and requirements for exemption. for example, illinois and connecticut adopted new legislation specifically regulating nonprofit hospital billing and collection practices. 77 this legislation includes the following: "notice require­ ments about available free care on all bills from debt collectors; prohibitions on the filing of collection lawsuits by hospitals against patients eligible for free care; setting required levels of discounts for low-income uninsured patients; and capping interests rates hospitals charge on hospital debt. "78 these con­ sumer oriented initiatives go toward imposing at the state and local level a cor­ responding burden on the hospitals for the significant tax benefits they receive. in the wake of class actions brought against nonprofit hospitals in califor­ nia federal court, the california legislature passed senate bill 379 in august 2004.79 although governor arnold schwarzeneggerultimatelyvetoed this leg­ islation, senate bill379 would have required nonprofit hospitals to develop charity care and reduced payment policies in­ cluding requirements for discounted or free care to pa­ tients whose income is at or below 4000/o of the federal poverty level. [d]evelop applications for charity care, provide oral and written notices to patients of the avail­ ability of charity care and discount policies, and limit to the whole community." id. at 5. 76 u.s. s. comm. on fin., taking the pulse of charitable care and community benefits at nonprofit hospitals. closing statement of chairman grassley, http://finance.senate.gov/hearings/statements/091306cg.pdf(last visited mar. 27, 2007). in his closing statement, senator grassley directed the finance committee staff to develop a staff dis­ cussion paper that would provide the finance committee members with proposals to consider in addressing the issues covered at the hearing with particular emphasis on those proposals consis­ tent with the community benefit standard. id 77 · batchis, supra note 51, at 505 & n.97 (citing the access project, hospital billing and collection: aha guidelines on providing financial assistance to uninsured low-income pa­ tients, http://www.accessproject.org/hospital.html (last visited mar. 12, 2007)). 78 id. 79 john p. krave, gerry hinkley & jill h. gordon, &hwarzenegger vetoes charity care billcalls for hospitals to implement hospital association's voluntary charity care guide­ lines, davis, wrigiit, 'tremaine,llp,healml.advisorybull., sept2004, at l,available at http://www.dwt.com/practclhealthcrlbulletins/09-04 _ charitycare.htm. 2007] nonprofit hospitals & uninsured patients hospital debt collection activities during the first 150 days after a patient's discharge. 80 189 historically, california had been a community benefit state. by compari­ son, this legislation seemed an attempt to move toward a charity care standard through the imposition of specific requirements on california's nonprofit hospi­ tals. governor schwarzenegger, however, chose to ask for the hospitals' volun­ tary compliance with guidelines proposed by the california healthcare association rather than to require them by statute. 81 senate bill 379 was, at least in part, an acknowledgment that the nonprofit litigation discussed in this note could potentially persuade unsympathetic juries to find in favor of the pa­ tients if nonprofit hospitals continued to appear unresponsive to the commu­ nity's concern over their charitable health services. 82 c. state attorneys general act on their role of supervising charitable organizations several state attorneys general brought claims against, or initiated investi­ gations of, nonprofit hospitals regarding their charity care practices. 83 gener­ ally, a state attorney general supervises charitable organizations, as well as individuals that solicit charitable funds, administer charitable assets, or both. the attorney generals for connecticut, minnesota, wisconsin, and lllinois have taken investigative action, brought suit, or proposed legislation in an effort to ensure that nonprofit hospitals within their respective states were meeting tax­ exempt obligations. 84 for example, illinois attorney general lisa madigan proposed legislation she believed would make certain that nonprofit hospitals were meeting their 80 /d. 81 /d. ("the 'voluntary guidelines' mentioned by governor schwar:zenegger are, in fact. the 'voluntary principles and guidelines for assisting low-income and uninsured patients' ... adopted on feb. 6, 2004 by cha [the california healthcare association]. the guidelines pro­ pose, among other items, that hospitals adopt and communicate policies whereby patients with incomes at or below 300 percent of the federal poverty limit be eligible to apply for financial assistance under charity care policies, and that hospitals should limit expected payments from these patients to 'amounts that do not exceed the payment the hospital would have received :from medicare, other government-sponsored health programs, or as otherwise deemed appropriate by the hospital."') (quoting california healthcare association's "voluntary principles and guide­ lines for assisting low-income uninsured patients"). 82 /d. 83 leo t. crowley, charity care cases: further developments, n.y. l.j., apr. 27, 2005, at 6 [hereinafter crowley it]. 84 /d. see also boulton, supra note 9 (discussing complaints filed by the wisconsin attorney general "accusing nonprofit hospitals of charging uninsured patients much higher prices than they charge managed care companies."). 190 indiana health law review [vol. 4:173 obligations as a tax-exempt organization.85 attorney general madigan ex­ plained, hospitals, when they decide to be nonprofits, they strike a deal with the state. the deal is that you don't have to pay property taxes, you don't have to pay sales taxes, you don't pay income taxes, and you get tax-exempt bonds when you do construction. for that multibillion­ dollar benefit, they have to provide charity care for peo­ ple. it's not a revolutionary idea out there. the hospitals know that is the deal they have struck. 86 whether this truly is the essence of the "deal struck" is a subject for another discussion because the standards and requirements for tax-exempt status vary from state to state and are not always as simple as free or discounted medical care in exchange for tax-exempt status. madigan's efforts were at least an at­ tempt to ensure hospitals were doing their part even within the broader commu­ nity benefit context. the lllinois hospital association, however, reports that hospitals in lllinois are currently providing more than one billion dollars annu­ ally in free medical care and some have even proposed that "a hospital's benefit to its community cannot simply be measured by the amount of free care (charity care) it provides. "87 this disparity highlights the tension between proponents of the federally adopted community benefit standard and proponents, particu­ larly those at the state level, of a charity care standard. d. advocacy groups acting on behalfpfuninsured patients certain nonprofit organizations have been working as advocates on behalf of uninsured patients and have proved to be highly effective not only in per­ suading hospitals to reduce or forgive patient debt but also in keeping the issue of hospital pricing in the national spotlight. the coordinated efforts of these organizations have also pressured hospitals to examine their pricing. if a hos­ pital assesses and consequently reduces the list prices for its services, then pri­ vate health insurance companies unable to negotiate lower rates on their own can also benefit. for example, consejo de latinos unidos, which is a national nonprofit organization based in los angeles, california, works to educate and represent uninsured latinos and others dealing with allegedly inflated hospital 85 matt adrian, illinois ag outlines proposal to increase hospital charity, quad-city times, jan. 24, 2006, available at http://www.qctimes.com/articles/2006/0l/24/news/state /doc43d5b7e440e48455965lll.txt. 86 id. 87 aaron chambers & andrea preston, plan seeks stepped-up charity care: officials at rockford's three hospitals are cool to the attorney general's proposal, rockford register star, jan. 24, 2006, at 6. 2007) nonprofit hospitals & uninsured patients 191 bills.88 mr. k.b. forbes founded this group in 2001 and has been successful in assisting overcharged patients to reduce or eliminate their hospital bills. mr. forbes and his group have also worked closely with plaintiffs' attorneys in­ volved in the for-profit and nonprofit hospital pricing litigation to secure set­ tlements from defendant hospitals and generally keep this issue in the national spotlight. 89 although some commend mr. forbes's efforts, others note that in addition to his victories on behalf of the uninsured, at least some private insurance ex­ ecutives are also benefiting. one such executive is mr. j. patrick rooney who has operated various successful insurance companies in indianapolis, indiana, while at the same time maintaining a prominent political presence in the health care sector. mr. rooney's company, medical savings insurance, a relatively small health insurance provider, at one time benefited from mr. forbes's ef­ forts. when for-profit tenet healthcare corporation, the nation's second­ largest hospital chain, finally yielded in 2003 to mr. forbes's pressure and agreed to implement discounts for the uninsured, tenet applied the discounts to medical savings insurance, which, unlike the much larger players in the indus­ try, could not negotiate significant discounts on its own.90 as a result of this pressure, tenet forgave at least $2 million in bills that rooney's company had refused to pay in protest over inflated prices and additionally agreed to accept reduced payments from rooney's company on future claims.91 in addition to his significant gop political contributions, mr. rooney pledged seed money to consejo de latinos unidos and hired a washington public relations firm to draw attention to its cause.92 a second national advo­ cacy group known as the hospital victims project, an effort of the fairness foundation, appears to have ties to mr. rooney as well. 93 the fairness foun88 see generally consejo de latinos unidos, about us, http://hospitalpricing.com /aboutus.asp (last visited mar. 12, 2007). 89 tamar lando, pocket protector: k.b. forbes is defending uninsured patients. never mind why, mother jones, may 1, 2005, at 22; see also 60 minutes: hospitals, is the price right? (cbs television broadcast mar. 5, 2006), available athttp://www.cbsnews.com/stories /2006/03/02/60minutes/main 1362808.shtml?source=search _story. during the house committee on ways and means may 26, 2005 hearing on the tax-exempt hospital sector, mr. forbes submitted a statement that made the following allegation: "although non-profit hospitals do wonderful life-saving work and give away millions in charity care and uncompensated care, the truth is after all the spin and all the public relations: the uninsured are still being charged three or four times more for the exact same care, executives are still being paid excessively, sometimes in the millions of dollars, the non-profits are still siphoning off billions in off-shore accounts." house hearing on tax-exempt sector, supra note 63, at 136. 90 lando, supra note 89. 91 lorraine woellert, making hospitals cry uncle, bus. wk., june 7, 2004, at 112 (dis­ cussing how mr. rooney has not only used the power of his ideas and political connections to make his company profitable but also to back consejo de latinos unidos, which uses hardball tactics to get hospitals to cut prices). 92 !d. 93 see generally hospital victims, http://hospitalvictims.com (last visited mar. 12, 192 indiana heal'ih law revmw [vol. 4:173 dation is cited as the source of statements and statistics appearing on consejo's web site regarding the hospital industry's alleged practice of overcharging the uninsured.94 the fairness foundation maintains a web site and operates out of the same address as medical savings insurance in indianapolis, indiana.95 the pressure coming from organizations like consejo and the hospital victims pro­ ject is troubling for hospitals because "[n]obody wants these cases where some­ one was sick and the big, bad hospital is suing them [to collect payment]," says mr. richard morrison, a vice president at orlando's adventist health system, who also said rooney's medical savings insurance owes adventist an esti­ mated one million dollars. 96 despite protests to the contrary, some industry insiders view the relation­ ship between advocacy groups and insurance companies as the means to an end that has directly benefited not only for the uninsured patients seeking relief from their hospital bills but also insurance executives wanting to challenge and reduce rates hospitals charge for their services.97 "rooney, who has led two insurance companies that specialize in selling both the health savings accounts and the catastrophic insurance policies, has lobbied hard for this 'consumer­ driven solution' to health care."98 the profitability of his company and the success ofhis initiatives depends, at least in part, on hospitals charging reason­ able rates for the services they provide. therefore, when consejo successfully pressures a hospital to reduce its rates, other interested parties stand to receive corresponding benefits. 2007). 94 see consejo de latinos unidos, how to defend yourself, http://hospitalpricing.com /wlinsured/defend.asp (last visited mar. 12, 2007) (citing the fairness fom1dation as the source of a report containing allegations of hospital billing practices). 95 see medical savings insurance, http://www.medicalsavings.com (last visited mar. 12, 2007); hospital victims, contact us, http://www.hospitalvictims.com/contactus.asp (last visited mar. 12, 2007). each of these web sites lists the same mailing address for their respective headquarters. 96 robert dreyfuss & peter h. stone, medikill, m01her jones, www.motherjones.com/news/feature/1996/01/medikill.html (last visited mar. 29, 2007). <rj lando, supra note 89. 98 lando, supra note 89; see also dreyfuss & stone, supra note 96. after pioneering health saving accom1ts with his old company, golden rule insurance, rooney sold golden rule to united health group inc. for $893 million and subsequentlyfom1ded medical savings insur­ ance in order to sell more health savings accom1ts. woellert, supra note 91. rooney, his fam­ ily, and employees, have donated more than five million dollars into republican causes since he developed health savings accom1ts in 1990. ld. president george w. bush and other republi­ cans showed their support for this proposed system ofhealth care when in 2003, gop lawmak­ ers inserted a $6.4 billion tax break for health savings accom1ts into a medicare prescription­ drug bill. lando, supra note 89. 2007] nonprofit hospitals & uninsured patients n. the consumer protection claims of 1he suiter health nonprofit hospital pricing class action 193 much of the attention surrounding nonprofit hospital billing of the unin­ sured is currently focused, at least in part, on the outcome of several class ac­ tions brought against nonprofit hospitals in state courts. stories of low-income uninsured persons receiving medical bills they cannot afford to pay have per­ meated the press. the grim reality for these individuals is that enormous or inflated hospital bills can cause severe health and consumer credit problems.99 the unprecedented, albeit relative, success obtained by the plaintiffs in the sut­ ter health hospital pricing class action in a california state court seemed to in­ dicate that the plaintiffs would finally have their day in court. the plaintiffs originally alleged eight claims100 in federal court, but the u.s. district court for the northern district of california dismissed the patients' federal claims in da" v. sutter health101 and also dismissed the state law claims for lack of ju­ risdiction without prejudice to refile in state court. the plaintiffs refiled a con­ solidated102 complaint in the superior court of california in july 2005 and subsequently survived defendant sutter health's initial motions to dismiss. 103 ruling against the hospital and in favor of uninsured patients, the superior court of california rejected the hospital's argument that uninsured patients only had recourse through the state or federal legislature and recognized that unin­ sured patients could seek relief directly in state court.104 this ruling showed particular promise not only for the plaintiffs, but also for similarly situated plaintiffs in other states that this case would go to trial and set new precedent for the handling of these claims brought under state consumer protection stat­ utes. although federal courts have overwhelmingly rejected challenges of non­ profit hospitals' business practices premised on theories arising from the government's contractual relationship with tax-exempt hospitals, plaintiffs could find success under the broad language of state consumer protection laws. defendant hospitals in similar cases have agreed to settlements early in the litigation; however, sutter health took a different approach and filed a class action claim in august 2005 against former patients who failed to pay their 99 batchis, supra note 51, at 497. 100 for a summary of the eight federal claims, see crowley i, supra note 8. 101 darr v. sutter health, no. c 04-02624 wha, 2004 u.s. dist. lexis 24592, at *17 (n.d. cal. nov. 30, 2004) ("'[i]n the usual case in which all federal-law claims are eliminated before trial, the balance of the factors to be considered under the pendent jurisdiction doctrine­ judicial economy, convenience, fairness, and comitywill point toward declining to exercise jurisdiction over the remaining state-law claims. 'j (citation omitted); see also crowley i, supra note 8, at 6 (listing reasons for the dismissal of these federal claims). 102 plaintiffs' attorneys consolidated the complaint with other similarly situated patients and changed the name of the case from darr v. sutter health to "sutter health uninsured pric­ ing cases." see complaint, supra note l. 103 statement from scruggs, supra note 18. 104 id. 194 indiana health law review [vol. 4:173 medical bills but did not qualify for the hospital chain's existing charity care program. 105 this unusual move came in the form of a counterclaim and seemed to add further support that the defendant hospital was prepared to defend its billing practices. 106 in august 2006, however, the parties in the sutter health litigation reached a settlement. although these plaintiff patients did not get their day in court, this note will explore the basis of their state law claims be­ cause it was the state consumer protection laws on which they were premised that seemed to have the greatest potential for carrying the case to trial. there is neither a federal nor state statute nor any common law principle that requires a nonprofit hospital to charge uninsured patients the same rates it charges to other patients.107 despite provisions in the california constitution and code specifically exempting nonprofit hospitals, california case law regard­ ing a hospital's tax-exempt status has generally supported the interpretation that '"lessening the burdens of government' is a factor that the california courts must consider when determining whether hospital property is entitled to exemp­ tion from real estate taxes."108 although plaintiffs in california were not di­ rectly challenging the hospital's tax-exempt status, they did allege that the hospital had misrepresented itself and engaged in unlawful, unfair, and decep­ tive practices under the guise of a community-based nonprofit organization re­ ceiving significant tax benefits. thus, the two causes of action which would likely have become the central issues of this litigation implicated california's consumers legal remedies act ("clra"), as well as alleged violations of california's unfair competition law ("ucl"). similar consumer protection statutes in other states could lead other plaintiffs to posit similar arguments. therefore, despite the settlement, a review of these claims remains relevant to this area of litigation since it is on consumer protection statutes that the plain­ tiffs have premised their challenge of nonprofit hospital business practices. a. california's consumers legal remedies act in 1970, the california legislature enacted the clra, which effectively permitted consumer class action suits for unfair methods of competition and unfair or deceptive acts undertaken by an organization that results in the sale of a good or service to a consumer. 109 section 1780 of the act provides that "[a]ny consumer who suffers any damage as a result of the use or employment 105 rachel osterman, sutter health takes gloves off in lawsuit, sacramento bee, aug. 19,2005, at dl. 106 jd. 107 crowley ii, supra note 83, at 3 (quoting kolari v. n.y.-presbyterian hosp., 382 f. supp. 2d 562, 579 (s.d.n.y. 2005)). 108 mcclendon, supra note 53, at 48 & n.16 (citing several cases supporting the "lessen­ ing the burdens of government" proposition). 109 diane e. dodge, the california consumers legal remedies act, 10 cal. w. l. rev. 161, 161 (1973). 2007] nonprobt hospitals & uninsured patients 195 by any person of a ... practice declared to be unlawful by section 1770 may bring an action .... "110 section 1781 of the act provides the class action as a vehicle for recovery. 111 specifically, the clra indicates three areas that afford the consumer protection: "a definite method of recovery for unfair competition, a statutory provision permitting collection of damages, and the consumer class action."112 nevertheless, theintentoftheclra was to balance the interests of the consumer and the merchant while not solely empowering the consumer to punish the merchant.113 section 1770 of the clra details the twenty-four un­ fair methods of competition and unfair or deceptive acts or practices that are considered unlawful for a merchandiser to undertake. in the sutter health class action, the uninsured patients claimed that the defendant violated four sections of the clra by engaging in "deceptive practices, unlawful methods of compe­ tition, and/or unfair acts to the detriment of plaintiffs and the class. "114 these causes of action alleged that sutter health incorrectly represented and adver­ tised the goods and services it provided to the uninsured, that it advertised the goods with the intent not to sell them as advertised, that the subject of a transac­ tion had been supplied in accordance with a previous representation when it had not, and that its full charges were unconscionable.115 11° cal. ctv. code§ 1770(a) (west 1998). 111 /d. § 1781 (a) (permitting the class action ''if the unlawful method, act, or practice has caused damage to other consumers similarly situated .... "). 112 dodge, supra note 109, at 162. 113 !d. at 161. 114 complaint, supra note 1, at 20; the clra prohibits twenty-four different business practices, but the four sections of the clra to which the plaintiffs refer are in california civil code section 1770(a). cal. ctv. code§§ 1770(ax5), (9), (16), (19) (west 1998). california civil code section 1770(ax5) provides in relevant part: "representing that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities which they do not have or that a person has a sponsorship, approval, status, affiliation, or con­ nection which he or she does not have." !d. § 1770(a)(5). california civil code section 1770(ax9) provides in relevant part: "advertising goods or ser­ vices with intent not to sell them as advertised." !d. § 1770(ax9). see consumer advocates v. echostar satellite corp., 113 cal. app. 4th 1351, 1362 (cal. ct. app. 2003) ("[r]eject[ing] defendants' view that a plaintiff must produce a consumer survey or similar extrinsic evidence to prevail on a claim that the public is likely to be misled by a representation .... federal cases holding otherwise do not accurately reflect california law."). california civil code section 1770(a)(16) provides in relevant part, "[r]epresenting that the subject of a transaction has been supplied in accordance with a previous representation when it has not." id § 1770(ax16). california civil code section 1770(ax19) provides in relevant part, "[i]nserting an unconscion­ able provision in the contract." id § 1770( a)(l9). see armendariz v. found. health psychcare servs., 6 p.3d 669, 689-90 (cal. 2000) (finding that unconscionability has a procedural and substantive element). 115 complaint, supra note 1. see also nat'l council against health fraud, inc. v. king bio pharm., inc., 107 cal. app. 4th 1336, 1348 (cal. ct. app. 2003) (''the falsity of the adver­ tising claims may be established by testing, scientific literature, or anecdotal evidence."). 196 indiana health law review [vol. 4:173 in vasquez v. superior court san joaquin county, 116 the california su­ preme court acknowledged the importance of the class action as a method for consumer protection. m the vasquez court held that consumers seeking a re­ scission of installment contracts could maintain a class action for fraudulent misrepresentation against a seller of freezers and frozen food and its finance company assignees. 118 the court noted two requirements for the maintenance of a class action: (1) the ascertainable existence of a class and (2) a well-defined community of interest in the issues to be litigated.119 with the decision in vasquez, the class action became the recognized vehicle in california for reme­ dying unlawful or unfair conduct that results from the sale of services to a con­ sumer in an effort to protect consumers from unscrupulous sellers. coincidentally, the california legislature adopted the clra while vasquez was still pending in the california supreme court. the court ac­ knowledged that the provisions of the clra were not exclusive, but rather the remedies it provides were in addition to remedies and procedures in other laws. 12° for example, if a plaintiff brought a claim under the clra alleging bad faith, then the clra provides that a court may award reasonable attorney's fees to the prevailing defendant. 121 the clra also states that its protections may not be waived by the consumer.122 similarly situated uninsured patients could rely on similar, liberally interpreted statutes if they exist in their respec­ tive states in their own challenges of hospital pricing. b. california's unfair competition law the ucl prohibits "any unlawful, unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising. "123 the cali­ fornia plaintiffs in the hospital pricing cases alleged that sutter health ''unfairly and unlawfully charge[ d] uninsured patients unfair, unreasonable, and/or dis­ criminatory rates that are significantly higher than those charged to its insured patients."124 fortunately for the plaintiffs in the california sutter health case, 116 vasquez v. super. ct. san joaquin cmmty, 484 p.2d 964 (cal. 1971). 117 james r. mccall, et al., greater representation for california consumersfluid recovery, consumer trust funds, and representative actions, 46 hastings l.j. 797, 800 (1995). 118 vasquez, 484 p.2d at 966. 119 id at970(citing daarv. yellowcabco.,433p2d732, 730-35(cal.1967)(noting principles that can help guide courts in determining whether the class action is an appropriate vehicle for claims of misrepresentation)). 120 id. at 975; see also cal. ctv. code § 1752 (west 1998) (stating that the remedies provided for are not exclusive). 121 cal. cn. code § 1780(d) (west 1998). 122 id. § 1751;seea/sobroughtonv.cignahealthplans,988p.2d67, 74(cal.1999). 123 cal. bus. & prof. code § 17200 (west 1997); wang v. massey chevrolet, 97 cal. app. 4th 856, 869 (cal. ct. app. 2002). 124 complaint, supra note 1, at 17. 2007] nonprofit hospitals & uninsured patients 197 "the extraordinary breadth of the ucl is matched by the liberality of its en­ forcement provisions."125 notably, california voters in 2004 adopted new leg­ islation requiring that ucl plaintiffs must meet certain standing requirements and that actions involving aggregated claims must proceed under california's class-action standards.126 no longer could a business be the target of claims on behalf of consumers who were likely to be deceived by the business practice or act; rather, plaintiffs now must prove actual injury. private litigants may not sue for damages; however, they may pursue injunctive relief in addition to resti­ tution and disgorgement of money wrongfully obtained by the defendants' use of unfair business practices.127 different liability standards and defenses exist for the three types of con­ duct under the ucl.128 although an unlawful business act can be any act that violates the law of any section of the california civil code, an unfair business practice includes those acts that may technically be lawful in the sense that they do not violate any other statute. 129 an action for unfair business practices exists when a business practice "offends an established public policy or when the practice is immoral, unethical, oppressive, unscrupulous, or substantially injuri­ ous to consumers. "13° california courts have generally held that a ucl claim premised on fraudulent conduct does not require proof of intent, scienter, actual 125 michaels. greve, consumer law, class actions, and the common law, 7 chap. l. rev. 155, 165 (2004). 126 julia b. strickland & lisa m. simonetn, stroock & stroock & lavan, llp, 2007 overview of california's unfair competmon law and consumers legal remedies act 1 (2007) ("on november 2, 2004, california's voters approved proposition 64 [which] put an end to 'private attorney general' ucl cases prosecuted by unaffected plaintiffs, purportedly on 'behalf of the general public."') (citing benson v. k wikset corp., 126 cal. app. 4th 887, 934 (cal. ct. app. 2005) (sills, p.j., concurring and dissenting) (commenting on the passage of proposition 64, "this case represents what will hopefully be the last of a breed of lawsuits against businesses where lawyers make big bucks, and clients nothing, for finding some tiny arguable technicality and bringing an unfair competition suit.") 127 !d. at 166 (citing bank of the west v. super. ct. of contra costa county, 833 p.2d 545, 557 (cal. 1992); cal. bus. & prof. code§ 17203 (west 1997 & supp. 2007)); see also dean witter reynolds, inc. v. super. ct. of alameda county, 259 cal. rptr. 789, 799 (cal. ct. app. 1989) (denying compensatory damages and instead adopting an equitable remedy of resti­ tution). 128 see strickland & simonetii, supra note 126, at 10--26 (discussing thoroughly rele­ vant california case law). 129 greve, supra note 125, at 165 & n.64. 130 people v. casablanca convalescent homes, 1nc., 206 cal. rptr. 164, 177 (cal. ct. app. 1984); accord cel-tech communications, inc. v. l.a. cellular telephone co., 973 p .2d 527,544 (cal. 1999) (adopting the following test for unfairness: "when a plaintiff who claims to have suffered injury from a direct competitor's 'unfair' act or practice invokes section 17200, the word 'unfair' in that section means conduct that threatens an incipient violation of an anti­ trust law, or violates the policy or spirit of one of those laws because its effects are comparable to or the same as a violation of the law, or otherwise significantly threatens or harms competi­ tion."). 198 indiana health law review [vol. 4:173 reliance or damages. 131 instead, the supreme court of california has held that "it is necessary only to show that members of the public are likely to be de­ ceived" in order to bring a claim for injunctive relief under the ucl. 132 how­ ever, the new legislation in california, adopted while the sutter health case was still pending, effectively eliminated the likely to deceive standard thereby af­ fording businesses greater protection than they had previously received under the ucl.133 although bolstered by the heightened standing requirements, a california hospital's strongest defense may be that it was somehow justified in its business practices or that the laws on which the conduct was alleged to be unlawful are no longer applicable or that the alleged fraudulent practice will not likely mislead. 134 the ucl provides for restitution, injunctive relief, and civil penalties, but no damages are recoverable.135 however, the clra explicitly provides for actual damages, restitution of property, punitive damages, and any other relief which the court deems proper.136 under the formerly broad application of the ucl, a defendant hospital risked liability by merely representing itself to the community as being a chari­ table organization providing, what the average consumer misinterpreted to be, free or discounted health care for those who qualify. ultimately, statements made to the public regarding the charitable purposes on which a hospital is founded are made to promote sales and services from those consumers who rely on such representations. if plaintiffs can show that the hospital subsequently billed at rates far in excess of its costs, engaged in discriminatory billing or ag­ gressive debt collection, or failed to negotiate available discounts for those who 131 see comm. on children's television, inc. v. gen. foods corp., 673 p.2d 660, 668 (cal. 1983); but see strickland & simoneiti, supra note 126, at 16 ("proposition 64 ... may substantially change the law in this regard. such that individualized proof of actual reliance will be required in order to establish standing on a claim of fraudulent conduct."). 132 kasky v. nike, inc., 45 p.3d 243, 250 (cal. 2002) (quoting comm. on children's television, inc., 67 p .2d at 668) (emphasis added); see also day v. at&t corp., 74 cal. rptr. 2d 55, 60 (cal. ct. app. 1998) ("a perfectly true statement couched in such a manner that it is likely to mislead or deceive the consumer, such as by fuilure to disclose other relevant informa­ tion, is actionable under these sections."). 133 reedsmith.com, special topics, california's business & professions code § 17200 (unfuir competition) and § 17500 (false advertising), available at http:/lwww.reedsmith.com/special_topic.cfin?cit_id=7 (last visited apr. 10, 2007) ("before prop. 64 was enacted, few plaintiffs asserted clra claims because the ucl provided so much flexibility and so many advantages. since prop. 64 helped level the ucl playing field, it appears there has been an increase in the number of clra claims asserted, although whether the clra will become as frequently misused as the ucl remains to be seen."). 134 strickland & simoneti1, supra note 126, at l 0-26. 135 korea supply co. v. lockheed martin corp., 63 p.3d 937, 948-49 (cal. 2003); but see strickland & simonetti, supra note 126, at 30 (citing both madrid v. perot systems corp. 30 cal. rptr. 3d 210, 219-20 (cal. ct. app. 2005) and feitelberg v. credit suisse first boston, llc, 36 cal. rptr. 3d. 592, 605 (cal. ct. app. 2005) (finding that nonrestitutionary disgorge­ ment is impermissible under the ucl)). 136 cal. civ. code § 1780(a)(l )-(5) (west 1998). 2007] nonprofit hospitals & uninsured patients 199 qualify then these actions could be considered by a sympathetic jury to be inju­ ries inconsistent with the supposed charitable nature the hospital espouses and for which it receives tax-exemption. 137 in support of such allegations, plaintiffs could highlight the contradiction between the hospital's billing practices and its stated mission. for example, plaintiffs may point to a hospital's messages appearing in advertising material as inconsistent with the practices the hospital implements. 138 plaintiffs might argue that a public representation appearing either on the hospital's web site or other advertising material contradicts the business practices an uninsured pa­ tient might encounter if he was billed for services at inflated or non-discounted rates. unfortunately for the hospital, the likelihood of deception is high per­ haps as a result, at least in part, of a confusing set of standards for tax­ exemption. in its defense, a nonprofit hospital may assert that its practices and polices are consistent with its statutory requirements such that it is generally providing a community benefit. but plaintiffs might provide testimony from community members, former patients, current hospital employees, or the hospi­ tal executives that demonstrates a history of business practices that had the ac­ tual, if not intended, effect of deceiving patients. essentially, plaintiffs would be arguing they were victims of a "bait and switch operation," where health care consumers entered a deal for the provision of medical services based on misleading information so that, as the plaintiffs alleged in the sutter health case, the hospital could make "enormous profits on the banks of the members of the community."139 such allegations are unsympathetic to the great work that hospitals do for their patients and for the community despite the strains of a problematic health care system. plaintiffs may have a difficult task in asserting that a hospital, that skillfully provided them with medical care, created a pricing structure to capitalize on the vulnerability of uninsured patients. nevertheless, critics argue, and sympathetic juries could agree, that nonprofit hospitals should be doing more to disclose their discount policies and adopting practices that are consistent with the charitable representations that they make to the public and justify their tax benefits. california's ucl grants courts considerable discretion to prohibit new 137 bate his, supra note 51, at 534. 138 see, e.g., sutterhealth.com, mission, vision and values, http://www.sutterhealth.org (last visited mar. 12, 2007). complaint, supra note 1, at 18. plaintiffs' attorneys pointed to a series of sutter health print advertisements that the hospital ran to educate the public about the current health care financing system and what the hospital was doing to make it better. id. these advertisements included several representations about the hospital's charity care practices and discount policies for the uninsured. !d. the plaintiffs cited numerous instances where sut­ ter health hospitals were not implementing charity care services consistent with the representa­ tions made in the advertisements. !d. 139 batchis, supra note 51, at 534; complaint, supra note 1, at 17; see also people v. custom craft carpets, 206 cal rptr. 12 (cal. ct. app. 1984) (finding that the carpet dealer was operating a bait and switch operation by advertising one kind of carpet but then selling another). 200 indiana health law review [vol. 4:173 schemes to defraud or deceive. for example, in people v. dollar rent-a­ car, 140 defendants, operators of car rental companies, were accused of misrep­ resenting collision damage waivers as insurance and then subsequently charg­ ing excessive amounts for repair of cars the customers damaged in accidents. the court of appeal found testimony from car rental employees, customers, and executives to be substantial evidence that the defendants were engaging in unfair competition and making false and misleading statements all in violation of the ucl.141 under similar interpretations of consumer protection laws in states other than california, plaintiffs might attempt to show that a defendant hospital's failure to notify patients of available discount policies for which the patients might qualify further supports allegations of unfair business practices, particularly if the hospital employees and executives had knowledge of these practices. the plaintiffs in the california suit alleged that sutter health "provides minimal 'traditional charity care' which sutter [health] describes as 'health care services provided to persons who meet certain criteria and cannot afford to pay. "'142 a court hearing similar claims may consider what exactly constitutes a reasonable rate. although arguably this is a question more appropriate for the legislature, similarly situated plaintiffs may highlight the disparity between rates charged to the uninsured and the rates accepted from government subsi­ dized programs in order to establish a scheme of unreasonable pricing. further, plaintiffs could point to a hospital's cost-to-charge ratios as a way of assessing hospital pricing for services. for example, the sacramento affiliate of sutter health reportedly made $502,006,278 in profits over a three year period. 143 during that time, costs increased by $121,103,228, but sutter health has in­ creased charges by $536,745,175!44 by this account, some estimate sutter health's cost-to-charge ratio to be 0.21 percent, which implies that sutter health charged $10,000 for services that actually cost them about $2,100 to provide.145 any truth to this theory of an alleged mark-up could prove trou­ bling for a defendant hospital if asked to justify its pricing in light of the tax benefits it is receiving. the california court of appeal found that presenting consumers with a bill that does not reflect the cost incurred by the service provider can constitute an unfair business practice. in dollar rent-a-car, a body shop repaired the defendant rental car company's damaged rental cars at a discounted ''whole­ sale" price for the repairs due to the high volume ofbusiness the defendant car 140 people v. dollar rent-a-car sys., inc., 259 cal. rptr. 191 (cal. ct. app. 1989). 141 !d. at 197. 142 complaint, supra note i, at 19. 143 wherethemoneygoes.com, sutter medical center, http://www.wherethemoneygoes .com (last visited mar. 12, 2007). 144 /d 145 /d. 2007] nonprofit hospitals & uninsured patients 201 rental company was giving the body shop. 146 subsequently, the rental car com­ pany prepared new repair invoices to be passed to the customers who caused the damage to the car, but these invoices reflected a higher "retail cost" rather than the actual repair costs the car rental company incurred for the repairs. 147 the car rental company never informed the customers of this practice, nor did the company supply customers with an itemized list of the inflated charges which led customers to believe they were paying the actual repair charges. 148 the california court of appeal found this failure to disclose inflated rates to be "misleading and constitut[ed] an unfair business practice."149 notably, dollar rent-a-car was about cars whereas the nonprofit hospital litigation involves human lives amidst a medical crisis. the nonprofit hospital litigation would likely garner significant attention from a sympathetic public. if the rates charged to the uninsured plaintiffs were in some way established as unreason­ able, not merely because they were charged to the uninsured, but because they reflect the list price charged with little correlation to the actual cost incurred by the hospital to render the service, then this could add further support to allega­ tions of unfair business practices. despite california's generous consumer protection laws, plaintiffs' attor­ neys should proceed with discretion when pursuing uninsured patients' claims. in california, plaintiffs should consider first whether they have the following elements to their ucl claim before moving forward: (1) a business practice that is demonstrably a violation of section 17200; (2) a business practice that can be narrowly and discretely defined so that an injunction can appropriately be crafted; (3) a means of calculating the illegal profit gained by the defendant in engaging in the practice; and ( 4) either identifiable victims to whom the restitutionary refunds can be made or who can be in­ cluded if the action is converted into a class action.150 california courts have consistently construed the ucl broadly requiring honesty, legality, and fair dealing in business practices affecting consumers, and california case law reveals that the statute has often been invoked to enjoin business conduct that falls short of those standards.151 time will tell what im­ pact the new standing requirements will have on california consumer protec­ tion claims. although it may be difficult for a court to determine what a 146 dollar rent-a-car sys., inc., 259 cal. rptr. at 194. 147 /d. at 195. 148 /d. 149 /d. at 197. 150 sharon j. arkin, the effective use of california's unfair competition law to redress managed care abuses, 22 whittier l. rev. 467, 503 (2000). 151 /d. 202 indiana health law review [vol. 4:173 reasonable rate would be for certain medical services, the more dramatic the injuries to the plaintiffs and the more outrageous the charged amounts, the more likely the courts may find a hospital in violation of similar unfair competition laws.152 v. the sutter health setilement on august 3, 2006, sutter health agreed to a settlement valued at more than $275 million which allows for thousands of refunds of between twenty­ five and forty-five percent on patients' prior hospital bills.153 sutter health of­ ficials say that the settlement will not change its charity care policies or proce­ dures noting that the hospital chain had already made changes to its charity care practices. 154 specifically, sutter health reports that, in march 2006, sutter health adopted a new policy for all of its affiliated hospitals that provides for those facilities to offer automatic discounts to uninsured patients that are comparable to the negotiated discounts that the hospitals provide to private insurance companies. under the tenns of the settlement, sutter's hospitals will continue to abide by this new policy for at least three more years. sutter health plans to maintain the policy indefinitely. 155 although the settlement may appear to be a victory for the uninsured, pa­ tient advocacy groups have opposed similar settlements in other jurisdictions, describing them as a temporary fix rather than a long-term solution. 156 mr. k.b. forbes of advocacy group consejo de latinos unidos explained that if a hospital adopts a new policy for discounting health care to the unin152 batchis, supra note 51, at 537. 153 rebecca vesely, sutter settles class-action lawsuit worth $275 million, the oakland trm., aug. 4, 2006, at 4. 154 victoria colliver, settlement reached in sutter lawsuit, s.f. chron., aug. 4, 2006, at cl. 155 press release, sutterhealth.org, sutter health settles lawsuit over prices charged to uninsured; reaffirms its charity care and discount policies (aug. 3, 2006), available at http://www.sutterhealth.org/about/news/news06 _ settlement.html. the sutter health policy dic­ tates that uninsured patients with annual incomes below 200 percent of the federal poverty income guidelines may qualify to receive free care. jd additionally, uninsured patients with annual incomes between 200 and 400 percent of the fpig are billed at rates well below those charged to private insurance companies and no uninsured patients, regardless of their financial status, apparently will receive a bill under this policy for full-billed charges at a sutter health hospital. id 156 press release, hispanicbusiness.com, providence health's settlement of"blatant and unfair discrimination" to be opposed by advocates for uninsured (nov. 4, 2005) (on file with author). 2007] nonprofit hospitals & uninsured patients 203 sured either in response to a settlement or on its own initiative, then "[t]he problem with tying discounts to a percentage off the full-billed prices is that it creates an incentive to raise the full-billed prices over time."is7 instead, these groups would prefer a system where the hospitals adopt discounted pricing poli­ cies that are tied, as sutter health has done, to the best managed care rate or federally reimbursed rates and then offer these discounted rates to all uninsured patients regardless of race, ethnicity, or income. 158 without such reform, set­ tlements that result in agreements to forgive patient debt or to develop new dis­ count policies tend to primarily benefit the defendant hospital and the plaintiffs' lawyers who cash in on the windfall. 159 moreover, temporary fixes impose no lasting obligations or system for monitoring their application. alternatively, legislative action may be the best way to create lasting change. legislative review of the tax-exempt sector at the state and federal lev­ els could result in further findings that the current statutory scheme creates an environment where tax-exempt hospitals are incurring disproportionate burdens in exchange for their tax benefits. new legislation could subject nonprofit hos­ pitals to stricter standards for qualifications of tax-exemption in order to maxi­ mize accountability and create an environment where the provision of free or discounted health care to qualifying patients is ensured. moreover, new legisla­ tion in the hospital tax-exempt sector could lessen the level of confusion and potential for misrepresentation and deception in the provision of health care. vi. conclusion the problem surrounding the provision of medical care to the uninsured exists, at least in part, because of a federal shift in tax-exemption standards from the "charity care standard" to the broader "community benefit" standard. as the public questions the justification of federal tax-exemption for nonprofit hospitals that allegedly bill low-income uninsured persons excessive rates, the public outcry is uncomplicated by states that have adopted differing require­ ments for state tax-exemption. although critics agree that the problem of the uninsured is bigger than the nonprofit hospitals' billing practices, they also suggest that the hospitals could do much more to help.160 nonprofit hospitals, as some already have, may take the initiative and begin to recognize uninsured persons as consumers who deserve better clarity and assistance in understand­ ing the financial obligations that could accompany medical treatment. but the voluntary adoption of charity care polices not obtained through a court settle­ ment or mandated by legislation cannot be enforced or monitored by courts or 157 !d. 158 !d. 159 !d. 160 cohn, supra note 13. 204 indiana health law review [vol. 4:173 legislators. 161 undoubtedly, the issues surrounding uninsured persons perme­ ates the nation's attention on many levels, but until there is greater clarity in the laws that provide for the exemption, there will likely be continued confusion for the patients. the nonprofit hospital pricing litigation has hospitals con­ cerned to the point that many have taken proactive steps to initiate change in their charity care practices. thus, as long as the litigation continues in state courts around the country, perhaps it will continue to exert pressure on hospi­ tals to examine and evaluate their charity care policies and procedures. regard­ less of the vested interests of the different groups behind the litigation, those plaintiffs who, although likely grateful for the care they received, are suffering under the financial burden of enormous hospital bills may at least find relief in settlement agreements even if the settlements fail to effect lasting change in the tax-exempt health care sector. california consumer protection laws, or similar laws in other states, may be broad enough to provide these patients with a favorable judgment or at least to carry these cases into state courts around the country. if this litigation con­ tinues to draw the attention of state and federal legislators, then it may instigate additional inquiries into the nonprofit health care sector to determine if and what kind of reform may be needed. state legislative action may be the best avenue for effecting change because the states would be in the best position to assess whether the adoption of stricter standards for tax-exemption mandating requisite levels of charity careas in discounted or free -to those who qualify is the best solution for handling the uninsured. in the meantime, these class action suits and settlements will likely prove effective in persuading hospitals to avoid future litigation by adopting charity care policies that are consistent with their charitable missions. the less their messages create confusion for patients, the better. 161 batchis, supra note 51, at 541. indiana heaith law review volume3 issue 1 mcdonald-merrill-ketcham memorial award for excellence in law and medicine history recipients beyond tort reform: fixing real problems articles randall r. bovbjerg controlling medical malpractice insurance costs-congressional act or voter proposition? h.e. frech iii, william g. hamm, c. paul wazzan my father, john locke, and assisted suicide: the real constitutional right sound constitutional analysis, moral principle, and wlse policy judgment require a clear and convincing evidence standard of proof in physician disciplinary proceedings new governance and soft law in health care reform notes john b. mitchell roy g. spece, jr., john j. marchalonis louise g. trubek duty-to-warn -even if it may be hearsay? deborah c. edwards the implications of a psychotherapists duty-to-warn a third person when information is obtained from someone other than his patient anti-depressants and children: timothy j. hixson suicidality. off-label use, and trial publication proper preemption or contrived construction?: travis p. meek why section 360k(a) of the fdca should not be interpreted to preempt state common law tort claims state innovation in health care: congress' broad tammy r. murray spending power under a national health care system will stifle state laboratories of democracy 2006 indiana health law review volume3 2005-2006 • editor-ln-chkf richard w. swett, jr. execliiwe miiiulging editor paula j. beller execlltlve production editor kathryn a. fox exec11tive bainess editor c. jason hannagan execliiwe notes editor deborah c. edwards execldhte articles editors joshua a. claybourn tammy r. murray note development editors richelle m. harris kristen w. heath kelly a. mackinnon erin w. southwell articla editors paul j. carroll meghann e. labadie christopher j. mcelwee april e. meade assodllteeditors timothy j. hixson april a. marshall jaclyn m. palos chad a. robertson robin s. tubesing christopher a. americanos . brent r. borg christopher m. campaniolo russell b. cate clifton b. cislak shana m. collier . bernice v. conway richard c. corning, jr. carly s. everett raegan m. gibson lauren n. grattenthaler angela k. grogan chelynne l. harris neil f. hazaray lynn m. hefuer adam hollander·urbach shannon n.jamison kimberly a. kessinger leigh ann lauth davidl.nie colleen m. powers elizabeth j. raynor beth a. schenberg rachel a scherer scott j. smith danielle l. spain brandt r. voight jennifer l. wilson ftlcii/tyadvlsors lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz indiana 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ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi couege school of law. dragomir cosanici, head ofr.tiference. b.a., michigan state university; m.i.l.s., university of michigan; j.d., university ofkansas. debra densla w, reference librorion. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school of law. malty hudson, reference/circulation librarian. b.a., ball state; m.l.s., indiana university. richard humphrey, reference librarian. a.a., bmwton-parker junior college; b.a., georgia southwestern college; m.l.s., university ofkentucky. wendell e. johntjng, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. chris e. long, catalog librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. mahnazk. moshfeoh,a.cquisitioni.s'eria& librarian. b.a., national university oflran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriama.murphy,associatedirectoroflawlibrory.b.a.,purdueuniversity;j.d.,m.l.s., indiana university-bloomington. ioyosiu orsu, computer. system specialist. a.a.> parkland college; a.b., m.s., c.a.s., university oflllinois. indiana health law review volume3 issue 1 table of contents mcdonald-merrill-ketcham memorial award for excellence in law and medicine history . . . . . . . . . . .· . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii recipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix beyond tort reform: fixing real problems ... randall r. bovbjerg 1 articles controlling medical malpractice insurance costs -congressional act or voter proposition? . . . . . . . . . . . h.e. frech iii, william g. hamm, c. paul wazzan 21 my father, john locke, and assisted suicide: the real constitutional right . . . . . . . . . . . . . john b. mitchell 43 sound constitutional analysis, moral principle, and wise policy judgment require a clear and convincing evidence standard of proof in physician disciplinary proceedings ..................... roy g. spece, jr., john j. marchalonis 103 new governance and soft law in health care reform ...................................... louise g. trubek 137 notes duty-to-w am even if it may be hearsay? the implications of a psychotherapist's duty-to-w am a third person when information is obtained from someone other than his patient . .. . . . . . . . . . . . . . . . . . . . . . . . .. . .. . . . . deborah c. edwards 171 anti-depressants and children: suicidality, off-label use, and trial publication . . . . . . . . . . . . . . . . . . . timothy j. hixson 201 proper preemption or contrived construction?: why section 360k(a) of the fdca should not be interpreted to preempt state common law tort claims . . . . travis p. meek 231 state innovation in health care: congress • broad spending power under a national health care system will stifle state laboratories of democracy .... tammy r. murray 263 2006 a chimera in every sense: standard of care for physicians practicing complementary and alternative medicine j. brad kallmyer, m.d.* introduction custom has generally defined the standard of care in medical malpractice claims against physicians. nevertheless, commentators and courts have been reluctant to hold the practice of complementary and alternative medicine ("cam") by physicians to be a per se breach of the standard of care even though cam is by definition not customary. despite this inconsistency, there has been little discussion and no consensus concerning what the standard of care is or should be for physicians practicing cam. this note concludes that a reasonable and prudent physician standard rather than custom better ad­ dresses the complexities of standard of care for physicians practicing cam. moreover, informed consent-usually a concept distinct from standard of care -must enter the standard of care analysis for physicians practicing cam because the patient's consent defines the extent of permissible deviation from the otherwise applicable non-cam standard. because this deviation can be defined by the patient, the standard has the potential to be different for two patients with identical medical problems. individual patient desires notwith­ standing, the physician maintains a duty to abstain from unreasonable prac­ tices. part i of this note discusses the background, scope, and complexity of the standard of care issue for cam physicians. part ll examines the validity of reasons to look beyond custom as the standard for practitioners of cam and concludes that cam warrants an exception to the use of custom as a deter­ minant of standard of care. part ill addresses the need for an informed consent contract. part iv analyzes the standard of care for cam through the lenses of alternative standard of care formulations, addressing some evidentiary and policy issues. this note concludes that a patient-specific reasonable physician standard best addresses the standard of care difficulties raised by cam. i. background increasingly accessible information has educated both providers and consumers of medical services about a wide array of nontraditional medical * b.a earlham college 1984, m.d. indiana university school ofmedicine 1988, j.d. candidate, indiana university school oflaw, indianapolis 2005. the author thanks christopher l. riegler from the law firm ofhall, render, killian, heath & lyman, p .s.c., for his assistance with this note. 226 indiana health law review [vol. 2:225 therapies outside the arsenal of modern; science-based biomedical treatment, the predominant treatment methodology taught in american medical schools.1 these nontraditional therapies comprise cam. serious consideration of cam by allopathic medicine ("biomedicine'') followed recognition of the prevalence of cam use. 2 even a decade ago, nearly sixty percent of mainstream physi­ cians had referred patients to cam practitioners. 3 currently, many physicians provide cam directly to their patients, obviating the need for referral. information about cam now appears commonly in the biomedical literature, and cam is part of the curriculum in many allopathic medical schools.4 in response to this surge in interest, the national institutes of health ("nih") established the national center for complementary and alternative medicine ("nccam'').s nccam defines cam as "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.'><; nccam notes that "[t]he list of what is considered to be cam changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. "7 cam practices 1. see nat'l ctr. for complementajy & alternative med., health information: what is complementajy and alternative medicine (cam)?, at http:/lwww.nccam.nih.gov/health/ whatiscam (last modified apr. s, 2005) (on file with the indiana health law review) [herein­ after nccam]. conventional medicine is medicine as practiced by holders of m.d. (medical doctor) or d.o. (doctor of osteopathy) degrees and by their allied health profes­ sionals, such as physical therapists, psychologists, and registered nurses. other terms for conventional medicine include allopathy; western, mainstream, orthodox, and regull!l" medicine; and biomedicine. some conventional medical practitioners are also practitioners of cam. id although osteopathic physicians frequently provide all of the services that a medical doctor provides, osteopathic physicians may provide additional services. "'steopathic medicine is a form of conventional medicine that, in part, emphasizes diseases arising in the musculoskeletal system .... some osteopathic physicians practice osteopathic manipulation, a full-body system ofhands-on techniques to alleviate pain, restore function, and promote health and well-being." id 2. see generally david m. eisenberg et al., unconventional medicine in the united states: prevalence, costs and patterns of use, 328 new eng. j. med. 246 (1993) (revealing, through a national survey, much greater use of unconventional therapies than previously reported). 3. jeffrey borkan et al., referrals for alternative therapies, 39 j. f am. prac. 545, 549 (1994). 4. white house comm'n on complementary & alternative med. pol'y, final rep. 51 (2002) [hereinafter white house comm'n], available at http://www.whccamp.hhs .gov/pdfs/ft2002 _document. pdf. 5. nat'lcenterforcomplembntary &alternative men., u.s.dep'tofhealth &humanservs.,nihpub.no.ol-500l,expandinghorizonsofhealthcare,five-year strategic plan 2001-2005 4, 11 (sept 25, 2000) [hereinafter horizons of healthcare], available at http://nccam.nih.gov/about/plans/fiveyear/fiveyear.pdf. 6. nccam, supra note 1. 7. id. it also bears noting that as some cam therapies are shown to be detrimental to health, their use may be restricted. for example, the fda issued an advisory after the supplement kava was shown to cause liver abnormalities. letter ftom christine lewis taylor, .. 2005] complementary and alternatne medicine 227 include homeopathic, naturopathic, chiropractic and herbal medicine; ayur­ veda; meditation; prayer; qi gong; and bioelectromagnetic medicine. 8 further, cam refers to acupuncture and some medical therapies that appear bio­ medical in nature but are labeled alternative by their practitioners; such as chelation therapy,9 hydrogen peroxide infusion, 10 or ozone therapy.11 from a legal standpoint, the practice of alternative medicine has thus far been primarily an issue for medical licensing boards.12 all states require licen­ sure for chiropractic practice, while many states require licensure to practice acupuncture, homeopathy, naturopathy, or massage therapy.13 although there are relatively few reported medical malpractice cases involving physicians practicing cam, an increasing number are likely to emerge as medical plans offer coverage for cam, 14 the number of physicians offering cam increases, and potential cases wind their way through often lengthy pre-trial processes. additionally, the dynamics of the patient-practitioner relationship in cam practice and the personal characteristics of many cam practitioners may have contributed to the historically reduced propensity of cam patients to sue. 15 as a broader constituency of physicians add cam to their practice repertoire director, office ofnutritional products, labeling. and dietary supplements, center for food safety and applied nutrition, u.s. food & drug admin., to health care professionals, fda issues consumer advisory that kava products may be associated with severe liver injury (mar. 25, 2002), at http://www.cfsan.fda.gov/-dms/ds-ltr29.html oast visited apr. 18, 2005) (on file with the indiana health law review). 8. nccam, supra note 1. this list is far from exhaustive. see also white house co:mm'n, supra note 4, at 9-10. some of the commissioners were disconcerted at co-optation of spirituality as a cam modality. joseph fins & tieraona low dog. appendix to white house comm'n, supra note 4, at 231. the commissioners also noted that "spirituality transcends any arbitrary designation of conventional and non-conventional medicine and cannot be claimed by any particular group. furthermore, the contlation of spirituality and/or religion with cam could lead to an abridgement of the ftee exercise of religion by subjugating its practice to a regulated modality." id 9. moore v. baker, no. 491-93, 1991 u.s. dist. lexis 14712, at *2 (s.d. ga. sept 5, 1991). 10. johnson v. tenn. bd. ofmed. exam'rs,no. m2002-00048-coa-r3-cv, 2003 tenn. app. lexis 226, at *16-17 (tenn. ct. app. mar. 19, 2003). 11. atkfusv.guest,601 n.y.s.2d234,236(n.y.sup.ct.i993);gambeev.bd.ofmed. exam'rs of or., 923 p.2d 679, 680 (or. ct app. 1996). 12. while there are significant differences between malpractice cases, administrative physician disciplinary cases, and insurance coverage cases, some disciplinary and insurance cases provide exceptional analysis of issues that have not yet been discussed in the malpractice context because their issues are pertinent here, a few of these cases have been discussed in this note. 13. licensing statutes vary by state and are obviously subject to amendment or repeal. for a relatively recent listing of state licensure statutes, see david a. studdert et al., medical malpractice implications of alternative medicine, 280 jama 1610, 1611 (1998); see also white house comm'n, supra note 4, at 102 (showing 2002 provider licensing requirements by state and specialty). 14. deborah a. grandinetti, your newest competitors: alternative-medicine networks, med. econ., may 24, 1999, at 44; studdert, sripra note 13, at 1610-ll. 15. studdert, supra note 13, at 1612. 228 indiana heal til law review [vol. 2:225 and nascent malpractice claims involving physicians' misadventures with cam advance to trial~ courts will reckon with novel cam malpractice issues, the chief of which will be standard of care. ·standard of care defines the physician's duty in medical malpractice actions. detennination of the standard of care for cam presents dilemmas and paradoxes. two have been discussed in the context of canadian law.16 first,· a standard of care paradox is created when a physician providing un­ proven cam therapy is at the same time generally expected to· use only therapy proven to be safe and efficacious.17 second, courts will be faced with the factual problem of deciding whether the physician-homeopath acted as a physician or as a homeopath . . . . while this may be easily discerned in the case of prescribing a homeopathic solution, other elements of treatment may plausibly be characterized as either medical or homeopathic. in such a situation, should a physician be able · to declare that she acted as a homeopath or should the applic­ . able standard be based on the patient's perception?18 physicians who provide cam in the united states have yet another problem: in the united states, physicians in most states are held to the standard of prevailing practice or custom as determined by expert witnesses.19 cam, by definition, is not customary. 16. timothy caulfield & colin feasby, potions, promises and paradoxes: comple­ mentary medicine and alternative medicine and malpractice law in canada, 9 heallh l.j. 183,200 (2001). 17. /d. at 200.02. 18. /d. at20l. this very issue recently arose inbd of registration for the healing arts v. mcdonagh, 123 s.w.3d 146, 149 (mo. 2003) (en bane). in mcdonagh, the board of registration disciplined osteopathic physician mcdonagh based on the physician's uncon­ ventional treatment of vascular disease. /d an administrative hearing commission(" ahc'') reversed, and this opinion was affirmed by the circuit court. id the missouri supreme court reversed the circuit court and remanded because the standard of care was not identified, and it appeared that the ahc judged mcdonagh's conduct by reference to expert witness physicians using mcdonagh's unconventional treatment rather than by reference to the standard of care of physicians treating patients with vascular disease. id the case also turned on evidentiary issues. see discussion infra part iv .a.4. 19. see also philip g. peters, jr., the quiet demise ofdeference to custom: malpractice law at the millenium, 51 wash. & lee l. rev. 163 passim (2000) (describing the decline of use of custom in favor of reasonableness, and categorizing states by type of standard). see generally barry r. furrow et al., heallh law § 6-2 (2d ed. 2000). generally, under the nationat·custom standard of care, a physician must conform to the practices that have become customary in the profession nationally, with allowable local variation in care based on resource availability. 2005] complementary and alternative medicine ll. should alternative medicine ever be within the standard of care? 229 any discussion of standard of care for the cam physician must~address the frequently cited issue raised by a new york court in charell v. gonzalez: "[l]t would seem that no practitioner of alternative medicine could prevail ... as the reference to the tenn 'non-conventional' may well necessitate a finding that the doctor who practices such medicine deviates from 'accepted' medical standards. "20 for a number of reasons, however, non-conventional care should not necessarily be considered deviant or unacceptable. a. patient autonomy patient autonomy provides the most compelling argument for acceptance of physicians' incorporation of cam into their practices. biomedical pater­ nalism has steadily eroded from the time of cardozo's landmark opinion in schloendotffv. society of the new york hospita/.21 with the erosion of the physician's ability to dictate the patient's treatment, the biomedical pro­ fession's ability to dictate what is considered acceptable treatment has likewise eroded. quoting schloendorff, the court of appeals for the second circuit made this explicit in schneider v. revici: [w]e see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment. while a patient should be encouraged to exercise care for his own safety, we believe that an informed decision to avoid surgery and conventional chemotherapy is within the patient's right ''to determine what shall be done with his own body. "22 20. cbarell v. gonzalez, 660 n.y.s.2d 665, 668 (n.y. sup. ct. 1997). 21. schloendortfv. soc'y ofthe n.y. hosp .• 105 n.e. 92,93 (n.y. 1914), overruled on other grounds by bing v. thunig. 143 n.e.2d3, 9 (n.y. 1957). the court noted that a surgeon operating without patient consent is not merely negligent, but is committing an assault. 22. schneiderv. revici, 817 f.2d 987,995 (2d cir. 1987) (quoting schloendolff, los n.e. at93). butcf. am.med.ass'n,cooeofmedicalethics § e-10.01 (2004) (hereinafter code of medical ethics]~ available at http://www.ama­ assn. org/ apps/p f_new/pf_ on line?f_n=browse&doc=po licyfi les/e1 o.oo.htm&&s_t=&st_p=&nth= i &prev _pol=policyfiles/hne/h525.998.htm&nxt_pol=policyfiles/hileie..o.ol.htm&. the ''patient has the right to make decisions regarding the health care that is recommended by his or her physician." jd (emphasis added). this implies a greater degree of control by the physician over the ·direction of treatment. 230 indiana health law review [vol. 2:225 the white house commission on complementary and alternative medicine policy3 extended this position in its recommendation that indivi­ duals participate "in all aspects of their care, including the development of new research agendas."24 thus, individuals are not only permitted to deter­ mine what is done to their own bodies, but are also encouraged to participate in ch~sing which therapies should be available to the public at large.25 1. the changing nature of the physician-patient relationship··· the increasingly collaborative nature of the physician-patient relation­ ship involves physicians in the cam choices of their patients whether physicians desire this role or not. the nih urges patients to be informed and to "take charge of [their] health," but adds that patients should involve their primary care doctor in the treatment plan for their safety.26 this implies the reciprocal: that primary care doctors be involved in their patients' decisions to seek cam treatment. furthermore, as part of its five-year strategy, nccam sees integration of cam as a necessary part of"an expanded repertoire of safe and effective treatments that include a focus on the whole person. "27 one nccam goalis to ''work to overcome the reluctance of conventional health­ care providers to consider cam therapies for their patients."28 this reluctance is implied in the american medical association ("ama") principles of 23. the white house commission on complementary and alternative medicine policy was created by president clinton and congress in 2000 with the mandate of developing "legislative and administrative recommendations that would help public policy maximize potential benefits, to consumers and american health care, of complementary and alternative medicine (cam) therapies • . • . " james s. gordon, chairman's v'ision, white house comm'n, supra note 4, at x. 24. ld. at xii (emphasis added). 25. public participation in developing research agendas seems to go beyond autonomy. when individuals participate in determining what is to be provided (or not provided) to the rest of society, the participation becomes political. indeed, many current issues in medicine have become politicized. the examples of fetal stem cell use and partial birth abortion illustrate the capability of political processes to control the availability of medical treatment. broad popular opinion, based on numerous factors in addition to science, drives legislation and funding decisions. 26. nat'l ctr. for complementary & alternative med., health information: are you considering using complementary and alternative medicine (cam)?, at http://nccam.nih.gov/healtb/decisions/index.htm oast modified feb. 5, 2004) (on file with the indiana health law review). 27. horizons of healthcare, supra note 5, at 21; see also michael h. cohen, beyond complementary medicine 33 (2000) (suggesting that as cam gains ground, ''physicians could be liable in malpractice for failing to provide complementary and alternative treatments"). be that as it may. the standard of care is defined in the here-and-now and cannot be based upon speculation about care in the future anymore than it can continue to accept past standards that have lost their support through scientific progress. when confronted with the argument that an alternative treatment may one day be accepted, one court responded succinctly that "the court does not have a crystal ball." moore v. baker, no. 491-93, 1991 u.s. dist. lexis 14712, at *15 (s.d. ga. sep. 5, 1991). 28. horizonsofhealthcare,supranote 5, at 15. 2005] complementary and alternative medicine 231 medical ethics, which add that the "physician has an obligation to cooperate in the. coordination of medically indicated care."29 here, the principles of medical ethics preserve the physician's ability to exclude therapies unilaterally through the definition of medically indicated care. despite the paternalistic bias of this section of the ama principles of medical ethics, the principles otherwise roughly conform to modern consen­ sus in acknowledging that the doctor-patient relationship has progressed from being merely consensual to collaborative.30 the physician is urged to seek "common ground" with the patient, so both doctor and patient are involved in the decision-making process. 31 finding common ground may require physi­ cian concession to reasonable patient requests for treatment outside of bio­ medicine. .this give-and-take negotiating, in which a physician considers (or proposes) cam at an early stage in treatment, opens communication and thus strengthens the doctor-patient relationship. 32 improved communication is likely to facilitate patient acceptance of conventional treatment if it is clearly safer and more efficacious or if an attempted cam treatment is ultimately unsuccessful. 33 patients undergoing cam at the direction of a physician can have the benefit of the physician's diagnostic and prognostic skills even if they are not undergoing optimal treatment by conventional standards. 34 2. cultural minorities, indigenous people and cam biomedicine is at least to some degree ethnocentric. 35 the names alone of many cam modalities reveal an origin outside of western european tradition. existing biomedical standards may be in place not because they are superior, but because biomedicine was already entrenched when proponents of a competing practice arrived on the scene, 36 or because biomedicine 29. code of medical ennes, supra note 22, at § e-1 0.01(5) (emphasis added). 30; codeofmedicalenncs,supranote22, at§ e-1 0.02; jerry a. green, collaborative physician-patient planning and professional liability: opening the legal door to unconventional medicine, 15 advancesinmind-bodymed. 83,88-89 (1999). 31. teaching this skill has become part ofthe family practice curriculum. see, e.g., east tenn. state univ. dept; of family med., doctor patient communication: resources, at http://qcom.etsu.edu/communication/resources.htm (last visited apr. 18, 2005) (on file with the indiana health law review). 32. green, supra note 30, at 84. 33. if the patient were not to agree to this plan, the physician's treatment amounts to little more than acquiescence to the patient's demands. 34. some states mandate.a conventional evaluation and detailed informed consent before cam can be offered. see, e.g., 22 tex. admin. code § 200.1-200.3 (west 2003). 35. kathleen m. boozang, western medicine oppts the door to alternative medicine, 24am. j.l. &med. 185, 199 (1998)(asserting, even more narrowly, that"[m]edicineremains substantially a white male profession ... "). 36. guido calabresi, ideals, beijefs, atl'l'rudes and the law 28-30 (syracuse univ. press 1985). a group is not assimilated until it has learned "to behave like the previously dominant group." it remains to be seen whether cam can survive mainstreaming. 232 indiana health law review [vol. 2:225 obtained dominance over competing practices through political processes37 or the westernization of indigenous people. 38 until the recent resurgence of alter­ natives, biomedicine had been spectacularly successful in driving out other schools of thought through educational reform in the early twentieth century. 39 ,considering cam to be within the standard of care may promote the health of those who may be part of a minority culture otherwise averse to bio­ medical treatment.40 indeed, the white house commission concluded that cam be provided with biomedicine, rather than as an alternative to biomedi­ cine.41 people with limited means and a cultural preference for cam should not be forced to choose between unproven but culturally preferred cam and proven biomedicine.42 additionally, some cam practices represent part of the "intrinsic uni­ queness" of an indigenous (or immigrant) culture that deserves preservation.43 conferring legitimacy solely upon biomedicine may deprive a minority of part of its culture and hasten that culture's extinction.44 this loss deprives bio­ medicine and "western" culture not of a medical curiosity, but of something of practical significance. for example, navajo methods of treatment have the potential for use in therapeutic jurisprudence, approaching crime "as an opportunity for healing rather than retribution and punishment.'"'5 obviously, if this means of rehabilitation were to be employed, practitioners (potentially physicians) would need to be trained in its use. thus, loss of alternative treatments may have wider consequences than the mere lost chance to treat individuals. 37. see generally paul starr, the social 'transformation of american medicine 79-144 (1982) (discussing the processes through which the practice of medicine in the united states became more uniform). 38. see robert b. porter, pursuing the path of indigenization in the era of emergent international law governing the rights of indigenous peoples, 5 yale hum. rts. &dev. l.j. 123, 131 (2002); james w. zion, navajo therapeutic jurisprudence, 18 touro l. rev. 563, 566(2002). 39. white house comm'n, supra note 4, at 13. 40. see kelly s. croman. note & comment, one size does not fit all: the failure of washington's licensing standards for alcohol and drug treatment facilities to meet the needs of indians, 72 wash. l. rev. 129 (1997). "[n]eglecting cultural differences in means of communication and healing models" has led to failure of efforts to treat alcohol abuse in indians. id at 141. 41. white house comm'n, supra note 4 at 100. 42. id at 17, 98-99. income may be a confounding factor in determining the preferences of some ethnic groups. id the report also noted that in the context of populations with limited access to conventional care, "cam becomes neither a complementary nor integrative intervention, but rather a less validated alternative to conventional care." joseph fins & tieraona low dog, appendix to white house comm'n, supra note 4, at 228. 43. porter, supra note 38, at 131. 44. id at 140-42. 45. zion, supra note 38, at 566. the author notes that ''navajos have persistently traditionally kept their traditional medical practices while accepting western medicine." id at 584w8s (footnote omitted). 2005] complementary and alternative medicine 233 3. regulatory limitation of patients' treatment options autonomy-based arguments for a libertarian approach to treatment not­ withstanding, the physician is not completely unbridled in granting' patient requests; various regulatory bodies may curb a physician's scope of practice. the supreme court has held that it is within the police power of the state to regulate physician's licensure46 and therapies that the physician mayprovide.47 indeed, ''there is no right to practice medicine which is not subordinate to the police power of the states. •>4s some aspects of medicine such as education (through licensure requirements for specific professions), human experimenta­ tion, and use of controlled substances are heavily regulated. 49 however, regu­ lation of specific therapies is sparse. 50 allowing a physician latitude in treat­ ment is probably wise policy: government-imposed standards could potentially mandate unsubstantiated treatment or preclude progress if a previously prohibited treatment were found to be beneficial when used in a different manner or within a different context 51 states have used their police powers in recent years to limit the ability of physicians in some jurisdictions to practice cam. for example, in in re guess, the north carolina supreme court reversed lower court rulings and upheld a medical licensing board decision to revoke guess' medical license because he practiced a limited amount of homeopathic medicine. sz discount­ ing that guess' treatment presented no threat of harm to his patients or to the public, and further discounting that guess' practices were allowed in other jurisdictions, the court based its decision solely on guess' deviation from ''the 46. crane v. johnson, 242 u.s. 339, 344 (1917) (holding that a state may distinguish between christian science faith healers and drugless practitioners for licensure purposes); dent v. west virginia. 129 u.s. 114, 128 (1889) (holding that states may establish conditions for medical licensure for the protection of society). 47. united states v. rutherford, 442 u.s. 544, 552 (1979) (validating fda evidentiary standards for effectiveness and upholding a decision to deny laetrile to cancer patients: "congress expressed concern that individuals with tatal illnesses, such as cancer, should be shielded from fraudulent cures"); lambert v. yellowley, 272 u.s. 581, 596-97 (1926) (upholdinglimitationonquantityofalcoholphysicianscouldprescribeformedicinalpurposes). 48. lambert, 212 u.s. at 596. 49. see, e.g. 42 u.s.c. § 289 (2004) (concerning institutional review boards, ethics and protectionofhumansubjects);2l c.f.r. §§ 50.1-50.56(2004)(concerningprotectionofhuman subjects); 21 c.f .r. §§ 56.101-56.124 (2004)(concerninginstitutionalreviewboards);seea/so controlled substances act, 21 u.s.c. §§ 801-830 (2004) (concerning standards, schedules, registration, and authority to control). states also regulate both human research and controlled substances. 50. see,e.g.,ariz.rev.stat.§§32-1401(gg),32-1501,32-2901(2003)(prohibitinguse of edta chelation therapy as a cam treatment, but permitting its use for other specified putposes); colo. rev. stat.§ 12-30-113 (2003) (proscribing the use oflaetrile). 51. barryr. f'urrowet al., 1helawofhealthcare0roanizationandfinance 13 (4th ed. 2001) (quoting alain enthoven, health plan: the only practical solution to the soaring costs of health care (1980)). 52. in re guess, 393 s.e.2d 833, 834 (n.c. 1990). 234 indiana heal1h law review [vol. 2:225 standards· of acceptable and prevailing medical practice'' as defined by the board. 53· licensing and other regulations usually operate in broad terms with respect to treatment, such as prohibiting practice of homeopathy in general. however, scrutiny has also been directed at specific practices collateral to delivery of medical care, such as marketing. the white house commission noted that "misleading and fraudulent health claims exist and are a cause for great concern.''54 especially susceptible to these fraudulent claims of efficacy are those "who are ill, have limited language or educational skills, or lack access to the conventional health care system .... "55 these unsubstantiated claims of efficacy have triggered federal trade commission ("ftc") action. for example, the ftc investigated the advertis­ ing and promotion of ethylene diamine tetraacetic acid ("edta") by the american college for the advancement of medicine ("acam'') as an effec­ tive treatment for atherosclerosis.56 because the claim of efficacy was not supported by research, the ftc found acam's promotion of edt a therapy false and misleading. 57 the ftc noted that m the health care field, "the con­ sequences of deception can be especially serious, causing not only economic injury by undermining consumers' ability to make informed choices, but creating risks to consumer health and safety.''58 although the ftc notes that its ruling applies only to "commercial speech, disseminated to consumers[,]" and not to "doctors acting in their individual capacities giving advice to [or treating] their patients",59 the ruling may chill physicians' enthusiasm for the use ofedta chelation therapy.60 thus, potentially unlimited patient demands, legitimatized by patients' recognized right of autonomy, are balanced by regulation and pressure from professionally controlled bodies such as licensing boards that may confine physicians' scope of practice. outside of these control measures, case law suggests physicians are generally granted wide latitude in exercising their 53. /d. at 835, 839, 840; see also whitb house comm'n, supra note 4, at 145 (recommending specifically that states not sanction practitioners solely because they are engaged in otherwise medically ethical cam research (as opposed to treatment)). 54. whitb house comm'n, supra note 4, at 69, 72. 55. /d. at 69. 56. prepared statement ofthefed trade. comm 'non "agency lockout on the off-label use of edt a chelation therapy": hearing before the house comm. on gov't reform, 1 06th cong. (mar.l 0, 1999) (presented by jodie bernstein, director, bureau of consumer protection) {hereinafter fed. trade comm'n],available at http://www.ftc.gov/os/1999/03/acamtestimony .htm; see also press release, fed. trade comm'n, medical association settles false advertis­ ing charges over promotion of "chelation therapy," (dec. 8, 1998), available at http:/lwww.ftc.gov/opa/1998112/acam.htm (on file with the indiana health law review). 57. fed tradecomm'n,supranote56. 58. /d. 59. /d. 60. see also whitb house comm'n, supra note 4, at 82-83 (discussing other ftc actions). · 2005] complementary and alternative medicine 235 professional judgment.61 under this regime, as long as a cam fl'eatlnent is provided by a physician exercising reasonable judgment, cam should npt be dismissed outright as a violation of standard of care until legislatures speak and prohibit it b. the conundrum oftaxonomy probably the most radical argument supporting cam suggests, with pos­ sible irony, that biomedicine could be considered a subset of energy medicine (cam) based on issues of legitimacy, precedence, and priority of beliefs.62 however, it is unlikely that the american health care establishment will ever accept this theory. cam practitioners are more properly considered to be operating within a separate paradigm from biomedicine, although the boun­ daries of the paradigms are sometimes far from distinct.63 philosophers of science would probably conclude that neither paradigm is likely to be explic­ able in terms of the other. 64 this precludes either cam or biomedicine subsuming the other. 61. although this may be more the case when courts address issues outside of mal­ practice. see, e.g., lesley v. chie, 250 f.3d 47,49 (1st cir. 2001) (holding in a suit alleging disability discrimination of an hn -infected patient "that the doctor's judgment is to be given deference absent a showing by the plaintiff that the judgment lacked any reasonable medical basis''); mcaleese v. owens, 770 f. supp. 255, 258,259 (m.d. penn. 1981) (noting that in prisoners' eighth amendment claims concerning their medical treatment, the propriety or adequacy of treatment is a question of sound professional judgment not to be second-guessed by the court, and that courts must exercise only a limited form of review); cowan v. myers, 232 cal. rptr. 299, 305-306 (cal. ct. app. 1986) (noting that for purposes of the medicaid act, legislatures may determine what general services are covered, but may not exclude a specific service for a covered condition if the physician determines that it is medically necessary and the plan makes the service otherwise available); state bd. ofmed. exam'rs v. rogers 387 so.2d 93 7, 939 (fla. 1980) (noting that a medical board's restrictions on a physician's practice "must be reasonably related to the public health and welfare and must not amount to an arbitrary or unreasonable interference with the right to practice one's profession .. . j. 62. cohen, supra note 27, at 81. 63. theodore pincus, differences between acute and chronic illness may clarify issues of orthodox versus alternative medicine and tort law versus collaborative planning, 15 advancesinmi:nd·bodymed. 99, 100 (1999)(responding to green. supra note 30). butcf. white house comm'n, supra note 4, at 5 (noting that many of the commissioners agreed that "scientifically tested" and "scientifically untested'' are better distinctions than "conventional" and "alternative" medicine). 64. see 1llomas s. kuhn, the structure of sc1entific revolutions 200 (2d ed., enlarged, univ. of chicago press 1970) (1962). kuhn claims "[t]here is no neutralidgorithm for theory-choice .••. " /d. kuhn points out that even though one view can never be proven ''true" to the other, learning about the opposing view is nevertheless still possible: [in making a choice between competing paradigms.] the choice is not and cannot be determined merely by the evaluative procedures characteristic of normal. science, for these depend in part upon a particular paradigm, and that paradigm is at issue. when paradigms enter, as they must, into a debate about paradigm choice, their role is necessarily circular. each group uses its own paradigm to argue in that paradigm's defense. the resulting circularity does not, of course, make the arguments wrong or even ineffectual. the man who premises a paradigm when arguing in its 236 indiana health law review [vol. 2:225 moreover, each group of practitioners will resist incorporation into the other. the more dominant biomedical paradigm has historically demonstrated antipathy toward cam. 65 evidence also suggests that many cam practi­ tioners are not seeking legitimization through scientific explanation of their practices.66 for example, despite biomedicine's ability to explain the effec­ tiveness of some herbal cam therapies in pharmacological terms, "many com­ plementary and alternative medicine practitioners regard herbs as sacred, having properties beyond the pharmacological.'~7 similarly, advocates of post-modernist and feminist theory argue that cam therapies which defy biomedical explanation do not require validation by biomedicine to be legitimate. 68 some cam proponents question even the statistical methods used by biomedicine to validate efficacy.69 a texas court defense can nonetheless provide a clear exhibit of what scientific practice will be like for those who adopt the new view of nature. id. at 94; see also michaelpolanyi, scibncb.faithandsociety 38 (univ. of chicago press 1964) (1946). polanyi suggests that the scientist cannot be a neutral arbiter: viewed from outside as we descn'bed him the scientist may appear as a mere truth-finding machine steered by intuitive sensitivity. but this view takes no account of the curious fact that he is himself the ultimate judge of what he accepts as true ... far from being neutral at heart, he is himself passionately interested in the outcome of the procedure. id. westernculture'spredilectionforscientificexplanationssuggeststhatanacceptedexplana­ tion of cam's effectiveness will probably be based on conventional biomedicine, rather than visa-versa. 65. see, e.g., wilk v. am. med. ass'n, 895 f.2d 352, 378 (7th cir. 1990) (affirming a district court's holding that the american medical association violated section one of the sherman antitrust act by conducting an illegal boycott directed at chiropractors). see gener­ ally starr, supra note 37, at 116-27. the american medical association was phenomenally successful in establishing academic, science-based medicine as the preeminent school in the first decades of the twentieth century. id in conjunction with other forces of reform and eco­ nomics, the well-known flexner report, created under somewhat concealed ama auspices, led to the homogenization of medical education through wide-scale elimination of non-scientific programs. id 66. green, supra note 30, at 92. 67. cohen, supra note27, at 107; see also michaelh. cohen, complementary and alternative medicine ll (1998). id when traditional chinese doctors prescribe herbs, they are basing their prescrip­ tions not on western chemistry and pharmacology but on the effect that these herbs, which have multiple active ingredients, will have on the patient's chi. similarly, acupuncturists' diagnostic and therapeutic roadmap ••• does not correspond to western anatomical systems. 68. caulfield & feasby, supra note 16, at 189-91. the authors note that some consider scientific truth to be merely a point of view. id at 191. however, cam is amenable to scientific study to the extent it makes specific claims. id 69. green, supra note 30, at 92; see also w:hlte housb comm'n, supra note 4, at xviii, 33-35 (recommending that the national science foundation develop methodology suitable for the study of cam); kathleen m. boozang, is the alternative medicine? managed care apparently thinks so, 32 conn. l. rev. 567, 602 (2000). cam proponents offer two alter­ native models for evaluating efficacy: pragmatic ejficacy, which "concentrates on the treatment setting to determine what is necessary to make a good clinical decision" in terms of the greatest total effect, and performative elficacy, which focuses on subjective factors such as patients' "symbols, belie~ suggestion, expectation and persuasion ••.. " id 2005] complementary and alternative medicjne bas agreed that cam may be valid despite lack of scientific explanation: there are a number of problems with [the] finding [that acu: puncture is an experimental procedure with unestablished '· safety and effectiveness.] to begin with, it appears to have been based on no evidence.~ .. [acupuncture] is no more experimental as a mode of medical treatment than is the chinese language as a mode of communication. what is experimental is not acupuncture, but westerners' under­ standing of it and their ability to utilize it properly. 70 237 in addressing access, the white house commission further suggested· that · cam provides value in its distinction from biomedicine, noting a "need to maintain cam styles of practice, rather than allowing them to be subsumed into the conventional medical model .... "71 market forces also function to keep the schools of practice apart. patients and other consumers of medical services who are dissatisfied with biomedicine as a profit-motivated industry may desire the separation so that they are not viewed as acquiescing to the tenets of that industry.72 this consumer viewpoint is validated by apparent government skepticism of physicians' ability to self-regulate as demonstrated by rising fraud, antitrust and kickback concerns. 73 despite paradigmatic incompatibility and the apparent desire of patients and physicians to keep cam and conventional medicine distinct. some courts have refused to distinguish the two. treating biomedicine and cam similarly prevents arrival at the logical conclusion that practitioners of nonstandard therapies are not practicing medicine, which would shield cam practitioners from prosecution for unlicensed practice. 74 courts reason the practice of medicine does not exclude certain methods of arriving at a diagnosis or per70. andrews v. ballard, 498 f. supp. 1038, 1053 (s.d. tex. 1980); cf. kuhn, supra. note 64, at 184-85. kuhn addressed the evaluation of one discipline using the paradigm of another, noting that the importance of values emerge when they are used to choose between incompatible ways of practicing a discipline: [t]hey must, first and foremost, permit puzzle-formulation and solution; where possible they should be simple, self-consistent, and plausible, compatible, that is, with other theories currently deployed • . . . other sorts of values exist as well-for example, science should (or need not) be socially useful .•.. ld. at 185. but see joseph fins & tieraona low dog, appendix to white house comm'n, supra note 4, at 227. two of the commissioners noted that "[w]hile dogmatic disbelief of everything that is not currently explainable is foolish, and indeed unscientific, it seems equally foolish to ask the taxpayer to bear the enormous expense of sorting out those areas that are plausible from those that are improbable." id. 71. white house comm'n, supra note 4, at xxvi. 72. peters, supra note 19, at 196-97. 73. id. 74. see, e.g., people v. amber, 349 n.y.s.2d 604, 607, 611-12 (n.y. sup. ct. 1973) (holding that an acupuncturist was engaged in the practice of medicine even though acupuncture does not conform to the tenets ofbiomedicine). 238 indiana heal til law review [vol. 2:225 forming treatment. 7s this argument has less weight in the malpractice context than in the licensing context, and the underlying concern is likely to become moot as states expand licensing laws that address cam practices. · biomedicine and cam are properly considered distinct schools of the healing arts, both recognized and valued, but with only biomedicine largely validated by science and cam remaining largely inexplicable in tenns of science. as noted in part ii.c.l, infra, until scientists have nothing further to discover, biomedicine's scientific explicability must be qualified as incom­ plete, so lack of explicability alone is insufficient to invalidate the use of any broad category of therapy. going further, schools that are so different that they are inexplicable in mutual tenns may require judgment by different stand­ ards.76 c. arguments against a standard of care for cam arguments against a standard permitting non-customary treatment tend to be more formalistic or based upon collateral concerns. 1. standard of care should be professionally determined and science-based because simply being reasonable and prudent supplies an inadequate basis upon which to make a good decision in a highly complex and technical field,. medical professionals are not held to the standard of ordinary care that applies in most tort law. physicians are expected to apply specialized know­ ledge that neither the ordinary reasonable person nor the patient possesses. paternalism, whether good or bad, is inevitable whenever decision-making power and responsibility is allocated in proportion to knowledge in the pre­ sence of gross information asymmetry. 77 relying upon the profession to deter­ mine its own standards and protecting the integrity of the profession through medical licensing laws probably results in a higher standard of care. 78 allow75. !d. 76. see calabresi, supra note 36, at 30. when a minority strives for equal footing, one must ask, "equality on whose terms, under which standaretr' !d. (emphasis in original). 77. in contrast to paternalism's usual negative connotation, it may be characterized positively as consumer protectionism in the relationship between physician and patient. see boozang, supra note 35, at 211. regulation ofhealth care through a state's police powers for consumer protection is also paternalism. id. 78. hayne e. leland, quacks, lemons, and licensing: a theory of minimum quality standards, 87 j. pol. econ. 1328, 1342 (1979); cj. randall g. holcombe, eliminating scope of practice and licensing laws to improve health care, 31 j.l. med. & ethics 236 passim (2003) (considering whether health care quality would improve without government regulation and posing an argument for private sector regulation ofhealth care); clark c. havighurst, the professional paradigm of medical care: obstacle to decentralization, 30 jurimetricsj. 415, 415-16 {1990) (maintaining that taking health care decision-making from the overly powerful medical profession and placing its control in the hands of consumers will benefit health care). 2005] complementary and alternative medicjne 239 ing standard of care to be dictated to any significant degree by popular senti­ ment o~; patient intuition and misperception risks: compromising the scientific rigor that establishes medicine as a profession,79 negates the element of the physician's specialized knowledge in establishing a professional standata of care, and removes the floor of acceptable treatment that a professionally defined standard provides. from the premise that the medical profession is distinguished by its specialized knowledge may ·rise the belief that standard of care should· not include any inexplicable treatment. 80 cam may be viewed as transcending mere inexplicability and entering the realm of religion or faith, rather than medicine.81 some fields, such as energy healing, do not fit neatly into either school. 82 . allowing non-professional appendages to the standard corrupts its protection of consumers from charlatans. eyen the white house commission, a strong cam advocate, expressed concern that recognition of and demand for treatment should not preempt a rigorous standard: [m]ost cam modalities have not yet been scientifically studied and found to be safe and effective. the fact that many americans are using cam modalities should not be confused with the fact that most of these modalities remain 79. seeboozang,supranote35,at209(assertingthatphysicianassenttounprovencam treatmentsaffirmspatients'beliefsinthebenefitsofcamand"perpetuate[s]asysteminwhich patients' ignorance results in their pursuit of care that they likely would not have elected had they been better informed"). .· 80. fed'nof8tatem1id.licensingbds.oftiieu.s.,model0uidelinesfortiieuse of complementary and alternative 'nmrapies in medical practice § id.5. (2002) [hereinafter model guidelines], available at http://www.fimb.org/policy«'/o20documents %20and%20whife0/o20paperslcam_modelpdelines.htm. "all physicians must be able to demonstrate a basic understanding of the medical scientific knowledge connected with any method they are offering or using in their medical practices as result of related education and training." ld. see also boozang. supra note 35, at 206-11 (arguing that unproven treatments should not be provided). 81. cohen, supra note 27, at 3; see also lauren a. greenberg. comment, in god we trust: faith healing subject to liability, 14j. contemp. healml. &pol'y 451,465 (1998). greenberg points out that faith healing has been given the status of medical treatment through medicare reimbursement for chri~ science healers, sanatoriums and skilled nursing facilities. see42 u.s.c.a. § 1395x(e)(west2004)(defining .. hospital"to include"areligious nonmedical health care institution"). · · 82. cohen, supra note 27, at 72-73. the author questions whether eriergy healers would be protected if credentialed as ministers. id how far energy healing may depart from bio­ medicine is well illustrated by discussion of the theory behind energy healing: the dominant assumption of energy healing is that disease originates in the biofield and precipitates into the physical body. this assumption correlates with the notions in holistic health that much of physical disease stems from emotional and spiritual imbalance, that illness is a message from the body, and the healing involves not only eradicating physiological symptoms and curing disease but also leading the person on an inner journey. id. at81. 240 indiana health law review [vol. 2:225 unproven by high-quality clinical studies. the commission believes that conventional and cam systems of health and healing should be held to the same rigorous standards of good science.83 in gambee v. board of medical examiners of the state of oregon, the defendant board applied the principles ofboth scientific purism and protection of professional integrity in making its decision to revoke the medical license of john gambee, an allopathic physician who provided ozone therapy to a patient: alternative methods of treatment are available from alterna­ tive providers. when a patient goes to a medical doctor or a doctor of osteopathy, he or she is entitled to presume that the physician will practice pursuant to scientific, orthodox principles. one of those principles is that unproven or un­ scientific therapies will not be provided, even for the best of motives, because of the risk of exploitation. dr. gambee's use of ozone with patient d.b., and his rationale for it, [that it would be harmless for a tenninal patient,] is not dissimilar to the use of laetrile. patients in these conditions are extre­ mely vulnerable to offers of hope of any kind from anybody for any price . . . . the principle is that the modality be scientifically based and justifiable. this board must protect that principle and the principle will protect the population. 84 during the course of dr. gambee' s litigation, the oregon legislature amended the unprofessional conduct statute-under which the board had revoked gambee' s license-to provide that ''the use of an alternative medical treatment shall not by itself constitute unprofessional conduct. • .as because the board had additional grounds upon which to revoke gambee's license, the court did not need to enter into what would have been a very interesting standard of care analysis to determine whether gambee's provision of unconventional treatment no longer required prevention. 86 when viewed from a practical rather than formalist standpoint, however, the board's concerns in gambee diminish considerably, especially if lack of scientific basis for treatment is disclosed to the patient moreover, the asser­ tion that medicine is "scientific" may be overstated. efficacy and physiologic 83. white house comm'n, supra note 4, at xviii. 84. gambee v. bd. of medical exam'rs for or., 923 p.2d 679, 680-81 (or. ct. app. 1996) (quoting the board ofmedical examiners). 85. ld at 681 (quoting 1995 or. laws spec. sess. ch. 2 § 1 (or. rev. stat. § 677.190(1))). 86. id at 682. 2005] complementary and alternative medicine 241 explicability are distinct concepts. efficacy of a cam treatment may be proven before a physiologic basis is discovered, 87 and even lack of proof of efficacy is not necessarily sufficient to prove that a treatment is not bene­ ficial.88 notably, some cam treatments are equal in efficacy to biomedical treatments that have potentially greater risk. for example, efficacy of spinal manipulation is similar to that of biomedical management of uncomplicated back pain;89 however, spinal manipulation does not entail the significant potential adverse effects of anti-inflammatory and pain pharmaceuticals.90 biomedicine likewise has a history of providing some minimally bene­ ficial "treatments'' in response to popular demand. male circumcision is an obvious example. although the procedure is generally not performed for reasons of medical necessity and has been performed for generations by non­ physicians, there is nevertheless a standard of care for its execution.91 another example is the requirement in some states that tattooing be performed by or under the supervision of a physician-a bizarre co-optation of a non-medical practice by medicine (or an assignment of the duty by state legislature ).92 87. while poorly understood from the standpoint of biomedicine, acupuncture is apparently effective as treatment for cocaine addiction. see horizons of healthcare, supra note 5, at 9 (citing s. kelly avants et al., a randomized controlled trial of auricular acupuncture for cocaine dependence, 160 archives internalmed. 2305 (2000) (claiming that use of acupuncture resulted in 53.8% of cocaine addicts testing negative for cocaine at the end of an eight-week study, while only 23.5% of those addicts treated with sham acupuncture tested negative)). 88. for example, current family practice literature recommends that physicians counsel patients on increasing physical activity even though published evidence for the effectiveness of routine behavioral counseling to promote physical activity is cmrently insufficient for the [united states preventive services task force] to recommend for or against including it in the periodic health examination .... "[i]nsufficient evidence to recommend" does not mean that such counseling has been shown to be ineffective. susanna e. guzman, am. acad. of family physicians, pracncal advice for family physicians to help overweight patients 13 (2003) (citing u.s. preventive servs. task force, behavioral counseling in primary care to promote a healthy diet: recommendations and rationale, at http://www.ahrq.gov/clinic/3rduspstf7diet/dietrr.htm (current as of dec. 2002)); see also u.s. preventive servs. task force, physical activity counseling, at http://www.abrq.gov/clinic/uspstfluspsphys.htm (last visited apr. 18, 2005) (on file with the indiana health law review) (providing the same recommendation). 89. willem j.j. assendelft et al., spinal manipulative therapy for low back pain: a meta-analysis of effectiveness relative to other therapies, 138 annals of internal med. 871 (2003). 90. cecil textbook of medicine 100-01, 116-18 (james b. wyngaarden et al. eds., 19th ed. 1992) (discussing narcotic and anti-inflammatory medication side effects). 91. see, e.g., mcguigan v. weiss, 52 pa. d. & c. 4th 308, 312 (2001 )(noting that use of non-absorbable sutures in a circumcision violates the standard of care). 92. see, e.g., conn.gen.stat.ann. § 19a-92a(west2004)(providingthat"[n]operson shall engage in tattooing except a physician" or certain medical personnel "under the supervision, control and responsibility of a physician"); mass. gen. laws ann. ch. 265 § 34 (west 2004) (providing that "[w]hoever, not being registered as a qualified physician ..• , marks the body of any person by means of tattooing, shall be punished by a fine . . . or by imprisonment ... or both"). although tattooing may be performed for medical purposes such 242 indiana healtii law review [vol. 2:225 2. economic factors in the interest of stewardship of funds, the scope of reasonable and necessary medical treatment covered by insurance is usually confined to efficacious treatments in order to maximize the benefit of money spent on health care. since most of cam is of unproven efficacy, it follows that cam should not be covered 93 while this conclusion strongly disfavors requiring third party reimbursement for cam, applying this argument morebroadly reveals the argument's limited applicability. subjecting all medical treatments to a cost-benefit test to determine whether a treatment is within the standard of care raises difficulties in the analysis of nearly cost-free cam modalities and extremely expensive heroic treatments. d. conclusion when "balanced against the wish to grant patients every opportunity to access healing, alleviate suffering, and move toward wholeness at every level of being,'>94 arguments that cam necessarily resides outside the scope of physicians' permissible practice and is essentially malpractice per se seem weak. although absolute exclusion of cam from permissible treatment may protect some consumers who would otherwise obtain less effective treatment, if cam is not malpractice per se, the consumer still has the protection of medical malpractice law if injured by cam, and the physician must still practice within the loose confines of state regulation. allowing the practice of cam may provide opportunities for innovation, may strengthen the rela­ tionship of trust and respect between patients and physicians, and is in step with emerging concepts of autonomy. allowing biomedical physicians to practice cam may encourage some patients that would not otherwise seek conventional care, but need it, to enter the system. permitting cam preserves practices that may have a broader cultural value. lastly, a standard of care must emerge for physicians practicing cam because, in a sense, the horse is already out of the barn. patients, courts, pro­ fessional societies, and governmental ~cies and commissions expect physi­ cians to provide, or at least coordinate, cam services. in response to these demands, as well as their own perception of appropriate medicine, physicians are providing the services and are being reimbursed. the argument that cam as marking of areas for radiation therapy, the statutes do not confine use of tattooing to medical purposes. 93. kathleenm. boozang,/s the alternative medicine? managed care apparently thinks so, 32 conn. l. rev. 567, 571, 606 (2000); see also boozang,.supra note 35, at 202-03. ''patients are likely to interpret health plans' inclusion of a particular treatment as an imprimatur on its efficacy, especially because patients perceive health plans in today's market to be restrictive in their coverage decl$ions." id 94. cohen, supra note 27, at 18. 2005] complementary and alternative medicine 243 is a per se breach of standard of care because it is distinct from customary, traditional biomedicine seems inadequate in this light. ill. informed consent · while informed consent and standard of care are generally distinct con­ cepts, informed 9onsent is critical to the standard of care analysis for cam physicians. [d]isclosure is rooted in patient autonomy and is character­ ized by an exchange of material information between physi­ cian and patient such that the patient can make an informed health care decision. in contrast, standard of care refers to the physician's exercise of reasonable care in the treatment of a patient and is characterized by the alleviation of patient suffering through the employment of physical and pharmaco­ logical means supported by professional custom and exper­ ience. standards of care are developed from within profes­ sions and, consequently, acceptable practices vary among the conventional and unconventional healing arts.95 informed consent must assume a greater role in cam than in conventional practice because cam involves a much greater degree of patient participation in directing and conducting treatment-for example, through nutrition, medita­ tion, and exercise--than in conventional medicine.96 because in many cases results are not judged by quantifiable, biomedical standards, there may be no clear indication of treatment success or failure, so success or failure must be judged subjectively. 97 informed consent in cam must not only address the items traditionally included in informed consent, 98 but must also address the question of who is to judge treatment success, and, derivatively, which para­ meters determine whether therapy is to be continued or discontinued.99 the type of consent necessary for cam, setting forth which decisions are to be made by the physician, which by the patient, and which are to be made 95. james a. bulen, jr., complementary and alternative medicine. ethical and legal aspects of informed consent to treatment, 24 j. legal med. 331, 334 (2003) (footnotes omitted). 96. green. supra note 30, at 86. 91./d. 98. see furrowet al.,supra note 19, § 6-11 (listing the traditional informed consent documentation requirements as including: diagnosis, nature and purpose of treatment, risks and outcomes, skill or status risks, alternatives, prognosis with and without proposed treatment, and conflicts of interest). · 99. green, supra note 30, at 89-93. 244 indiana health law review [vol. 2:225 joid.tly, 100 is therefore more in the nature of a contract than informed consent would be in the case of conventional treatment. a. contract issues defining duty through contract is nothing new. furthermore, in applica­ tion of the assumption of risk doctrine, there is precedent for application of a contractual definition of duty in cam medical malpractice cases.101 the collaborative nature of the physician-patient relationship in cam makes the importation of contractual concepts less problematic in some respects than it would be in the case of conventional, more paternalistic, medi­ cine. moreover, because the medical profession controls standard of care both in tort law and through its influence on licensing and state medical board actions, it is largely self-regulatory and is ideally situated to provide the para­ meters and boundaries of contract concerning type of care. 102 several lines of arguments support allowing contractual definition of standard of care through an informed consent document. first, the contract respects autonomy because limitations on treatment in part constitute patient refusal of conventional care, rather than physician dictation of cam. that a physician's acceptance of this refusal is not contrary to public policy has some well accepted precedent: policy favors honoring jehovah's witnesses' express refusal ofblood even when refusal threatens the individual's life and receiving 100. id at 89; see also havighurst, supra note 78, at 428-29. the author also notes a potential economic benefit of determining standard of care through contract: [p]roviders and consumers could come to their own arrangements with respect to how the risks of medical treatment should be borne. not only might parties to such contracts redefine their respective rights and responsibilities in the event of an injury, but they might also redefine the standard of care by specifying parti· cular services that a patient would or would not be entitled to receive. id. at428. 101. see schneider v. revici. 817 f.2d 987, 989 (2d cir. 1987) (holding that express assumption of risk was available as a total defense in the case of a physician providing non-con­ ventional cancer treatments) (emphasis added); cf boyle v. revici, 961 f.2d 1060, 1061-62 (2dcir.l992)(holdingthatabsenceofawritingdoesnotjustifykeepinganexpressasswnption of risk issue from the jury); see havighurst, supra note 78, at 429. havighurst questions "[ w]hether courts would respect contractual alterations of consumers' tort and other rights .... " id apparently some courts are willing to consider it. 102, some state legislatures have enacted statutes permitting such use of contract and man­ dating inclusion of certain provisions. see, e.g., ind. code ann. § 25-22.5-1-2.1 (west 2004). the patient may consent to nonconventional treatment if(1) a physician personally examines and agrees to treat the individual, (2) the risk of the treatment is not unreasonable or significant, and (3) written and oral informed consent is obtained which discloses the nonconventional nature of the treatment, the unapproved status of any drugs or devices used, and the material risks of the treatment's side effects. id. furthermore, "[t]he medical licensing board shall develop protocols" for these treatments with which the physician must comply or be subject to discipline. id see also, e.g., mo. code reos. ann. tit. 4, § 150-2.165 (2004) (providing the consent form to be used for edta therapy). 2005] complementary and alternative medicine 245 blood is strongly recommended by the physician.103 second, because cam is by definition non-customary, parties' expectations cannot be reasonably assumed, and a contract is desirable in that it defines these expectations. third, public policy, general tort law and general contract law will still provide boundaries to protect health care consumers. for example, cam physicians will not be able to enforce contracts of adhesion, contract out of negligent behavior, or enforce contracts that violate federal or state law.104 · 1. documentation of refusal of conventional treatment while infonned consent of some sort is usually required before provision of medical treatment, if the treatment is unproven or has been shown to be less effective than the conventional treatment, the consent assumes additional importance. lnfonned consent would show not only that the patient chose a less efficacious or proven therapy, but also that the patient specifically refused the more efficacious or proven treatment with knowledge of the risks. the document is a necessary part of a communication and educational tool that makes doctor and patient expectations explicitly and clearly delineated.105 the consent fonn should demonstrate that the patient was indeed infonned of the conventional treatment, its benefits, and perceived superiority over the cam treatment, as well as any hann that may come to the patient by foregoing the conventional treatment. furthennore, the infonned consent document should expressly descnoe the treatment plan to set the expectations ofboth the physi­ cian and patient. in 2002, the house of delegates of the federation of state medical boards of the united states approved model guidelines for the use of com­ plementary and alternative therapies in medical practice ("model guide­ lines"), developed by its special committee for the study of unconventional health care practices.106 two of the committee's goals were to "protect legiti103. see, e.g., shorter v. drury, 695 p.2d 116, 124 (wash. 1985) (en bane) (holding that jehovah's witness that refused blood and died during a medical procedure did not assume the risk of doctor's negligence, but did assume the risks associated with her refusal to permit a blood transfusion). 104. see, e.g., tunld v. regentsofuniv. ofcal.,383 p.2d441,447 (cal. 1963) (holding that definition of rights concerning duty of care through contract at the time of hospital admission is contrary to public policy as a contract of adhesion); vodopest v. macgregor, 913 p .2d 779, 785-87 (wash. 1996) (holding that an exculpatory clause in a human research project on high altitude sickness would release defendant from liability only if plaintiff's high altitude sickness on a mt. everest trek occurred as a result of a recreational activity, but enforcing the clause would be prohibited by public policy and by federal human research regulations if defen­ dant's injury was caused by research). 105. cohen. supra note 27, at41 (footnote omitted). "[s]cholars have urged a shift from the authoritarian, formulaic, and inflexible disclosure of informed consent, to a partnership between physician and patient in an atmosphere of conversation and shared exploration. this shift suits complementary andalternativemedicine'semphasis on patient responsibility for self­ care." id. i 06. model guidelines, supra note 80, at introduction. 246 indiana health law review [vol. 2:225 mate medical uses of cam while avoiding unacceptable risk., and to "encour­ ag[ e] the medical community to adopt consistent standards ...... 107 among other things, the model guidelines note that the medical record should docu­ ment ''whether or not certain options have been refused by the patient''108 adoption of the model guidelines by state medical boards would aid-in a con­ sistent approach to standard of care determination for cam by requiring this documentation. 109 one commentator has suggested that: state medical boards could issue approved forms of informed consent for various forms of alternative medicine and provide the patient with all relevant information. if a competent, adult patient, being fully informed as to all the pros and cons of a particular treatment, nevertheless elects to go ahead with the treatment, then where is the harm? the state has fulfilled its legal duty to insure safe and effective medical care by requiring full disclosure to the patient. the physician is pro­ tected from medical board disciplinary action for the mere use of an alternative or complementary treatment which does not meet the generally accepted standard of care. the patient has autonomy and the physician has medical freedam. 110 this advice has been implemented to a limited extent: missouri has promul­ gated a consent document specifically for provision of edta chelation therapy of"no medical or osteopathic value ...... m 2. definition of the school of practice and of the expectations of the parties informed consent is the most reasonable solution to the physician­ homeopath as physician or homeopath dilemma discussed above.112 because practice and standard of care vary among the biomedical and the numerous cam schools, the school must be defined prior to treatment so that both doctor and patient know which standard applies. several courts have noted that when a patient calls upon a physician for treatment, it is the patient that has chosen the school of practice, and the 107. id 108. id § m.l 109. glenn e. bradford & david g. meyers, the legal and regulatory climate in the state of missouri for complementary and alternative medicine:-,.honest disagreement among competent physicians or medical mccarthyism?, 70 umkc l. rev. 55, 98-99 (2001). 110. id. 111. mo. code regs. ann. tit 4, § 150-2.165 (2004). 112. see supra note 18 and corresponding text. 2005] complementary and alternative medicine 247 patient cannot later hold the physician to the standard of a different school.113 if 11 physician practices within two schools, the traditional biomedical school and cam, the patient should expressly indicate the school in which he or she is seeking treatment. ·if• no ·consent has been obtained and the physician and patient dispute which school should apply, the law should favor the patient as the jess sophis~ ticated party, and the school providing the more efficacious treatment-hi~ medicine by definition-should supply the standard. this acknowledges that cam creates an exception to the usual formulation of standard of care, and that proof of the exception must be shown (with burden of proof on the physician) before it can be invoked. b. informed consent does not excuse physicians from the duty to exercise sound judgment or the duty to refer documentation that the patient desires cam treatment exclusively does not immunize the cam physician from liability for exercising unsound judg­ ment. in kelly v. carroll, the washington supreme court ruled in favor of the plaintiff when a drugless practitioner prescribed castor oil, pineapple juice treatments and abdominal massage for appendicitis.114 the court reasoned that "[a] knowledge of what not to do may, in some instances, be indispensable to the patient's safety."m a cam methodology may not be applied in the wrong context. the kelly court reasoned: while it is true that a [ drugless] practitioner ... is not, in his limited field, required to be an insurer of results any more than a doctor of medicine, still, if he steps out of his limits and undertakes to treat a disorder for which, in the highest level of medical science, there is a generally recognized treat­ ment, such interloper must be held accountable to the accepted standard of treatment.116 113. van siclde v. doolittle, 169 n.w. 141, 142 (iowa 1918). the court held that objection to testimony of an allopathic physician concerning standard of care in the trial of a homeopathic physician should have been sustained: in calling a physician. a person is presumed to elect that the treatment shall be according to the system or school of medicine to which such physician belongs, and it would be unfair to measure such treatment by any other than the standards of such school; and the law will not tolerate testing treatment according to one school by the standards of another. id at 142; see also spead v. tomlinson. 59 a 376, 378 (n.h. 1904) (aff'd on reh 'g) (holding that when plaintiff employed a christian science faith healer, plaintiff could not later hold the faith healer to the standard of an allopathic physician). 114. kellyv. carroll, 219 p.2d 79,81-82 (wash. 1950). 115. id. at 85 (emphasis added). . . 116. id at 86; see also. wilcox v. carroll, 219 p. 34, 36 (wash. 1923) (attaching significance to commonalities of diagnostic training and some portions of treatments of both drugless practitioners and allopathic physicians in the care of patients with appendicitis). 248 indiana heal til law review [vol. 2:225 other states have likewise ruled that an alternative practitioner must recognize when treatment in that practitioner's alternative school will be inef­ fective. 117 minnesota has gone so far as to require that cam providers recom­ mend that their clients see a licensed health care provider "if there is a rea­ sonable likelihood that the client needs to be seen by a licensed or registered health care provider."118 applying this standard only to physicians, the model guidelines also recommend that the medical record document ''that proper referral has been offered for appropriate treatment . . . . "119 neither the minnesota statute nor the model guidelines require referral, however, so analysis of the applicability of either requires inquiry into reasonable profes­ sional judgment. thus, both case law and statutes have required that cam practitioners recognize the limitations of their schools and recommend that patients seek conventional care if indicated. in jurisdictions that adopt a minnesota-type requirement, the reasoning behind the requirement for non-physician cam practitioners should logically apply to cam physicians as well, requiring them to discuss and provide for biomedical treatment if indicated. thorough docu:tnentation is necessary not only to show that proven treatment or a referral was offered and rejected, but also to show that both physician and patient recognize the risks of pursuing cam treatment and foregoing biomedical treatment. 120 c. conclusion informed consent assumes a broader role in cam than in conventional medicine. first, because a physician providing cam services may practice in either of two schools, the school must be identified to establish the expecta­ tions of both provider and patient. second, because much of cam is un­ proven, the patient must specifically and expressly refuse treatments shown to be efficacious before the unproven treatment is provided, and the consent should document both risks of cam treatment and risks of foregoing bio­ medical treatment. third, contingencies signaling treatment endpoint, failure, or need for referral or change in treatment plan need to be determined up front. fourth, because the patient may be an active participant rather than a passive recipient in the treatment, the responsibilities of the patient and physician must be delineated. 117. rosenberg v. cahill. 492 a.2d 371, 379 (n.j. 1985) (noting that a chiropractor has the duty to recognize tumors on x-rays of a child and refer the child for conventional treatment). 118. minn. stat. ann. § 146a.08(x) (2004) (emphasis added). 119. model guidelines, supra note 80, § lli.l. 120. if a cam modality has not been shown to be effective, foregoing biomedical treatment and receiving cam treatment may amount to receiving no treatment at all. the consent should make this clear. if cam is provided to augment a biomedical treatment, the consent should make clear what benefit the patient is receiving from the biomedical treatment and from the cam treatment. 2005] complementary and alternative medicine 249 iv. standard of care the standard of care imposes a minimum level of acceptable medical service. although medical treatment may sometimes be obvious malpractice by any standard, 121 medical custom, as defined by the medical profession, generally defines standard of care in medical malpractice.122 however, custom is not the only means by which standard of care can be defined. comparing the standard of care analyses for cam using the tests of the alternative stand­ ard of care doctrines illustrates the strengths and weaknesses of each. a. present standard of care formulations the standard of care as it is currently understood in most jurisdictions evolved from the locality rule, which based standard of care on the prevailing practice or custom of physicians in the same or a similar community.123 the primary criticism of the locality rule was that it exonerated physicians per­ forming to a low local standard and encouraged a conspiracy of silence to protect an incompetent local colleague.124 1. the national standard as medical education became uniform across the coun1ry and communi­ ties were no longer isolated from medical progress, a standard of care based upon practices in the locality became antiquated, and a national standard evolved. 125 the standard is national because it is established by experts who are not required to be from a community similar to the defendant physician's 121. in guerrero v. smith, 864 s.w.2d 797, 798-99 (tex. app. 1993), a licensed, self­ styled "homeopathic" physician injected a patient with concoction of vitamins. minerals and dimethylsulfoxide in numerous locations without using sterile technique. when the patient developed infection, the doctor refused to prescribe antibiotics but "told her to drink her morning urine instead." id at 799. 122. the reasonable person standard is otherwise the norm in tort law. 123. seegenerallyfurrowetal.,supranote 19, § 6-2. 124. id 125. see hall v. hilbun, 466 so.2d 856, 866-875 (miss. 1985) (tracing the history of the locality rule both in mississippi and other states, and providing justification for limiting its applicability in favor of a "competence-based national standard of care"); see also barry r. furrow, broadcasting clinical guidelines on the internet: will physicians tune in?, 25 am. j.l. & med. 403,406-07 (1999). the author notes: i d. aphysicianeamsadegreebasedonstandardizedandhighlyscientificeducation, takes standardized medical boards and specialty tests and thereafter attends continuing medical education (cme) and periodic recertification courses. most professional medical training and education concentrates on eliminating marginal, unproven and incompetent physicians through uniform institutiorial processes. 250 indiana heal1h law review [vol. 2:225 community.126 the standard is customary in that the experts testify to custo­ mary or prevailing practice. 127 the advantage of the national standard for the plaintiff patient is that the minimum standard that a patient may expect in a backwater can be no worse than the minimum acceptable standard in a medi­ cally sophisticated community, taking into account availability of relevant resources. medical standard of care determined by custom of any sort has increas­ ingly come under attack due to improved dissemination of information and the proliferation of practice guidelines in the past two decades. 128 courts, while continuing to invoke custom, have placed growing emphasis on reason­ ableness, 129 which has replaced custom as the standard of care in a substantial minority of states.130 additionally, as the trend toward increasing patient auto­ nomy places more of the decision-making power in the hands of the. patient, custom may lose any remaining relevance because of non-uniformity in patient risk preferences.131 custom is also dependent upon economic factors that do not have their origin within the profession: treatment is influenced by what is considered economically feasible, 132 as well as by what is covered by insur­ ance,. "funktionlust, "133 the doctor's love of doing (and continuing to do) what the doctor does, and inertia both tend to make practices self-perpetuating, extending the life of customs even though superior treatments might be avail­ able. 134 that custom closely follows the development of new technologies and ideas may also be a myth: the convergence of custom and technological pro­ gress requires an unrealistic assumption of informational homogeneity and 126. furrow et al., supra note 19, § 6-2b. 127. id 128: see generally, jodi m. finder, the future of practice guidelines: should they constitute conclusive evidence of the standard of care?, 10 health matrix 67, 93-95 (2000); donald k kacmar; the impact of computerized medical literature databases on medical malpractice litigation: time for another hellingv. carey wake-up call?, 58 omo st. l.j. 617, 633-44 (1997) (discussing the possibility of incorporating physicians' accessing of internet databases into standard of care). 129. reasonableness in the medical malpractice context requires expert testimony just as medical custom requires expert testimony. 130. see peters, supra note 19, at 164. 131. james a henderson, jr., & john a siticiano, national healthcare reform on trial: universal health care and the continued reliance on custom in determining medical malpractice, 79 corneill. rev. 1382, 1392 (1994). the authors note, "in short, because highly complex medical decisions must ultimately pass through the portal of patient ignorance and fear, the kind of common understanding upon which custom depends is unlikely to arise." ld 132. id at 1394. 133. joseph h. king, jr., in search of a standard of care for the medical profession: the "accepted practice" formula, 28 v and. l. rev. 1213, 1267 (1975). 134. barry r. furrow, broadcasting clinical guidelines on the internet: will physicians tune in?, 25 am. j.l. & mj:!p, 403,413-14 (1999) (discussing barriers to physicians' use of practice guidelines).· 2005] complementary and alternative medicine 251 denies any disparity among physicians in understanding of innovation, accep­ tance of innovation, and application of innovation to practice.135 2. two schools of thought and respectable minority standards·· one response to the observation that physicians do not move in lock-step has been development of the doctrinally similar ''two schools of thought" and "respectable minority" doctrines. these doctrines posit that a practice cari be within the standard of care if it is an accepted alternative manner of treat­ ment.136 at first blush, the two schools of thought standard appears to be ideal with respect to cam; however, in application it becomes ,problematic. first, the standard is unreasonably advantageous for the defendant physician because it greatly expands the pool in which a defendant may find experts with similar potentially bizarre views, 137 setting the minimum level of care to which a patient is entitled unreasonably low. for example, although edta chelation therapy for atherosclerosis has been thoroughly discredited by the biomedical community, an expert in moore v. baker estimated that "approximately one thousand physicians routinely treat occlusive arterial disease with edta .... "138 alinost any practice, no matter how harmful, en­ gaged in by a considerable number of practitioners could be presented as the standard of care under this formulation.139 135. henderson & siliciano, supra note 131, at 1391. 136. jurisdictions vary widely in the language used to define the standard. for an excellent overview of jurisdictional variation, see michael kowalski. applying the "two schools of thought" doctrine to the repressed memory controversy, 19 j. legal med. 503, 505-24 (1998). pennsylvania courts, despite a long experience with two schools of thought doctrine, have struggled with its definition and application. in jones v. chidester, 610 a.2d 964, 969 (pa. 1992), the pennsylvania supreme court settled long confusion over the doctrine by holding the correct statement oflaw to be: where competent medical authority is divided, a physician will not be held responsible if in the exercise ofhis judgment he followed a course of treatment advocated by a considerable number of recognized and respected professionals in his given area of expertise. id. non-specific terms "considerable number," "recognized and respected," and "area of expertise" are all problematic with respect to cam practitioners. 137. robert l. park, translating science into law: lessons from doctors,. judges, and lawyers about the use of medical evidence in the courtroom: science in the courts, 36 new eng. l. rev. 575, 576 (2002). the author comments that ''there is no claim so preposterous that a ph.d. scientist cannot be found to vouch for it." id there is no reason to suppose that espousal of preposterous ideas is limited only to non-medical doctors. 138. moorev. baker, no. 491-93, 1991 u.s. dist. lexis 14712,at*l3 (s.d. ga. sep. 5, 1991). 139. in a sense, this may be criticized as taking the locality standard at its worst and "simply enlarg[ing] the professional frame of reference." king, supra note 133, at 1240-41. 252 indiana healm law review [vol. 2:225 while some precedent exists as to the absolute number of physicians necessary to define a minority, 140 defining who should be included in the minority or secondary school is more problematic. should the minority in­ clude practitioners solely of cam or dual cam-biomedicine practitioners? the first group is likely to be large, and the second very small. moreover, the former does not closely match the characteristics of the defendant physician because its members are generally not considered to have the knowledge and skills of a physician, which has been a key determinant of the non-physician cam practitioner's standard of care.141 given the wide range of cam practices, difficulty also arises in finding a comparable dual practitioner. 142 even if a practitioner can be found, "the court may still have trouble discerning a coherent standard of care-one that is somehow distinct from either conven­ tional or alternative medicine-against which to judge the· defendant's conduct. "143 second, even if the minority can be defined, the difficulty of paradigm still exists. for example, in mu"ay v. state health benefits commission, in­ surance coverage of colonic irrigation for treatment of dysbiosis144 was at 140. this number may be significantly less than i 000, which would suggest a very small minority. see, e.g., leech v. bralliar, 275 f. supp 897, 899, 902 (d. ariz. 1967) (noting that a total of sixty-five physicians nationally sufficed to establish a minority view). 141. wengel v. herfert. 473 n.w.2d 741, 743 (mich. ct. app. 1991) (noting that a chiropractor cannot be held accountable for failing to do what he is prohibited by law from doing); spead v. tomlinson, 59 a. 376, 378 (n.h. 1904) (noting that law cannot require a christian science faith healer to exercise the skill he is known not to possess); see also kerkman v. hintz, 418 n.w.2d 795, 802 (wis. 1988) (holding that if a patient presented with a problem which is outside of a chiropractor's license to treat, the chiropractor only has a duty to inform the patient of that and does not have a duty to refer to a medical doctor). but see minn. stat. ann.§ 146a.08(x) (west 2004) (requiring a cam provider to provide clients "with a recommendation that the client see a health care provider who is licensed or registered by a health-related licensing board or the commissioner of health, if there is a reasonable likelihood that the client needs to be seen by a licensed or registered health care provider); salazarv. ehmann, 505 p.2d 387,390 (colo. ct. app. 1972) (holding that a duty to refer to medical practitioners exists because of an oath chiropractors take pursuant to state law); roberson v. counselman, 686 p.2d 149, 152 (kan. 1984) (noting that testimony of another chiropractor that defendant chiropractor had a duty to refer was sufficient evidence of duty to withstand a summary judgment motion when defendant chiropractor had treated rather than referred a patient having chest and arm pain and known to have heart disease). 142. david m. studdert, legal issues in the delivery of alternative medicine, 54 j. am. med. women'sass'n 173,175 (1999). 143. /d. 144. this diagnosis, known under a variety of names (such as "systemic candidiasis") is not widely recognized by biomedicine, and its somewhat bizam treatments have generated at least one malpractice claim against a cam physician. see johnson v. tenn. bd. of med. exam'rs, no. m2002-00048-coa-r3-cv, 2003 tenn. app. lexis 226, at *18 (tenn. ct. app. mar. 19, 2003). in johnson, patient e.h. had a stroke when johnson, a physician with additional training in alternative medicine, used intravenous hydrogen peroxide, ozone treatments, and vitamin c injections for polysystemic candidiasis, which the board of medical examiners found constituted gross malpractice. id. the court of appeals concluded that "there was ample evidence that, regardless of whether it is considered 'alternative medicine,' johnson's treatment ofe.h. went well beyond unorthodox, that it was below the standard of 2005] complementary and alternative medicine 253 issue.145 among reasons that coverage was denied was that although the therapy ''was prescribed by a doctor, the prevailing medical opinion within the appropriate specialty was that such services were not safe and effective."146 considering testimony ofboth cam experts and the state's gastroenterologist, the commission reasoned that "( c ]olonic hydrotherapy is prescribed only by a few doctors practicing integrative or alternative medicine. since it is not deemed safe and effective by the appropriate specialty, it follows that the pro­ cedure needs further evaluation before it would be accepted as appropriate treatment. "147 furthermore, the commission did not accept the argument that because there were no ongoing studies, the treatment was not "experimental or investigational" (and by default, appropriate and warranting coverage); the commission noted that this reasoning could lead to the possibility that "treat­ ments that were totally bizarre and unworthy of study could not be declared experimental or investigational."148 on appeal, the court was "somewhat concerned" with the commission's rationale: "despite the lack of definitive medical studies, the [ c ]ommission found that because the procedure was prescribed only by doctors practicing alternative medicine and was not deemed safe by traditional doctors, 'it follows that the procedure needs further evaluation before it would be accepted as appropriate treatment. "'149 the commission had ruled that gastroentero­ logists established the appropriate custom.150 in essence, the [c ]ommission has stated that because few to no traditional doctors prescribe this treatment, then the altercare, and was in fact dangerous." /d. at *24. johnson's medical license was revoked. id at *19. the existence of an actual disease state corresponding to what has been variously labeled systemic candidiasis, dysbiosis, or yeast allergy has spawned heated debate among physicians. for opposing points of view on the legitimacy of this diagnosis, see h. santehnann et al., effectiveness ofnystatin in polysymptomatic patients. a randomized, double-blind trial with nystatin versus placebo in general practice, 18 family pracnce 258 (2001) (finding effectiveness of treatment despite no firm diagnostic criteria) and stephen barrett, dubious "yeast allergies," quackwatch, dec. 18, 2002, at http://www.quackwatch.org/olquackeryrelatedtopics/ candida.html (last visited apr. 18, 2005) (on file with the indiana health law review) (lambasting the diagnosis as pseudoscience). the polarizing issue is the level of scientific rigor needed to make or even to justify the existence of the diagnosis. similar problems have arisen in recognition of the diagnosis of multiple chemical sensitivity. see generally jack w. snyder et al., injury and causation on trial: the phenomenon of "multiple chemical sensitivities, "2 widener l. symp. j. 97 (fall1997). 145. murrayv. state health benefits comm'n, 767 a.2d 509,510 (n.j. super. ct. app. div. 2001). 146. id at 512. 147. /d. 148. /d. at 513. the plaintiff categorized the therapy as appropriate (covered) because it was not experimental, while the commission viewed it as experimental (not covered) because it was inappropriate. 149. /d. at 513-14. iso. id at 514. 254 indiana health law review [vol. 2:225 native practices must be experiinental or investigational. and, therefore, under this ratiorulle, the converse is true, that a treatment will become non-experimental only when tradi­ tional doctors begin prescribing or become supportive of the treatment. 151 the court admonished that in future cases, "the [ c]ommission should carefully consider whether the 'appropriate specialty' should be alternative ucensed medical practitioners of the proposed treatment rather than whatevertraditional medical specialty may be related to the treatment. "152 whether or not one agrees with the court's reasoning, from a practical standpoint, the court did not change the outcome that would have been obtain­ ed· by the commission's reasoning. after apparently opening the door to recognition of the cam physicians as a respected minority, the col;lrt imme. diately slammed the door shut by couching the conditions for acceptance of a minority standard in terms that only conventional treatment could fulfill: if a licensed alternative medical provider indicates that the treatment is based on sound medical, biological or scientific principles; widely prescribed and recognized by other alter­ native medical providers; and considered ejjtcacious and safe, the commission should not reject the treatment solely because traditional doctors do not yet utilize the treatment or are completely unfamiliar with the practice.153 as discussed in part ii, scientific explanation and proof of efficacy generally occur only within. the framework of the biomedical paradigin; which is not the paradigm in which a "licensed alternative medi~ provider" operates. further­ more, the cam treatment at issue will not, by definition, have a basis in medical, biological, or scientific principles. in determining whether a cam practice falls within the standard of care under the ''two schools of thought" doctrine, a trier of fact would experience confusion similar to that of the court in mu"ay. determining whether cam is an accepted alternative manner of treatment would involve a similar battle of experts speaking from the perspectives of paradigms lacking common­ ality.154 151. murray, 767 a2d at 514. 152. id 153. id (emphasis added). 154. alternatively, if the applicable rules of evidence require that expert testimony meet rigorous scientific standards. there may be no qualified expert to serve as a proponent of the cam minority. see discussion infra part iv .a.4. 2005] complementary and alternative medicine 255 3. the reasonable physician standard: best basis for an approach to cam the reasonable physician standard is similar to the accepted practice standard articulated by professor joseph k.ing.155 simply stated, "[p ]riktices approved by the profession, not necessarily those customarily followed by· its members, would be controlling."156 this standard provides three advantages when applied to medical malpractice: first, the model would foster a higher standard of care, the "best standards of the day"; second, it would be in keep­ ing with use of an "ideal paradigm" as a standard; and third, it is less depen­ dent on professional consensus.157 in theory, even an unprecedented practice would be within the standard of care if it were considered sound.158 the texas supreme court applied a similar standard in hood v. phillips. 179 in hood, a surgeon who had performed carotid body surgery on a patient with emphysema acknowledged that his treatment was not genetally accepted, but that this treatment had been successful in. his hands. 160 experts testified variously that the procedure had been found ineffectual and aban­ doned, or was potentially harmful. 161 the jury did not find the doctor grossly negligent 162 the court of appeals reversed, finding that an ordinary negli­ gence standard should apply, with the method of treatment supported by a respectable minority.163 the texas supreme court reached the same conclu­ sion on different grounds, concluding that in the case of treatments that are unaccepted-experimental, outmoded, or rejected-the jury should be asked, "[ d]id the physician undertake a mode or form of treatment which a reasonable and prudent member of the medical profession would not undertake under the same or similar circumstances?"164 the court further noted that using an unaccepted treatment could show a "conscious indifference to the welfare" of the patient and warrant "submission to the jury of an issue concerning gross negligence and, accordingly, an issue regarding exemplary damages."165 the texas supreme court noted that the circumstances juries are to consider may "include, but are not limited to the expertise of and means avail155. see generally king, supra note 133, at 1213. 156. id at 1213, 1236. 157. id at 1213, 1237-39. 158. id at 1238. 159. hood v. phillips, 554 s.w.2d 160 (tex. 1977). 160. id. at 162. . 161. id 162. id 163. jd at 164. tberespectableminorityevidentlyhad to comprise more than the defen­ dant alone. 164. ld at 165. the nde of law is: "a physician who undertakes a mode or form of treatment which a reasonable and prudent member of the medical profession would undertake under the same or similar circumstances shall not be subject to liability for harm caused thereby to the patient" id 165. hood, 554 s.w.2d at 166. 256 indiana healm law .review [vol. 2:2.25 able to the physician-defendant, the health of the patient, and the ·state of medical knowledge."166 this approach would offer clear benefit if, in addition to application to cases involving outmoded, rejected,-or experimental treatment, it were applied to cam as well. 167 this .standard obviates the need to detennine whether a therapy prescribed as cam more properly fits iji one of these other categories, since alt non-accepted (non-customary) therapies are treated similarly. · to the factors to be considered by the jury (expertise of physician, health of patient, and state of medical knowledge) should be added the enhanced infonned consent or collaborative. plan,. which. documents the dialogue between cam practitioner and patient.· testifying.experts would not only examine the treatment with respect to th~ patient's medical problem, but also · the treatment with respeci to the specific patient's desires, taking into account both patient expectations and "notions of professional responsibility. "i68 this approach values any "special insight''169 the physician gains through familiarity with the patient as an unique individual, rather than mere familiarity with the patient's pathology. in· addressing cam practice by licensed physicians, the state of ohio took a similar tack in its statutory treatment of alteinative. medical treatments by including an element of reasonableness in its definition of cam: "'alter-: native medical treatment' means care that is complementary to or different· :from conventional medical care but is reasonable when the benefits and risks of the alternative medical. treatment and the conventional medical care are 166. !d. at 165. . . . . . . 167. there is significant overlap of these categories. for example, homeopathic medicine had its origins in a european theory of pathology that ·hld been disproven by sub!!equent · scientific discovery. $ee boozang. supra note 35, at 195 (describing the history and theory of homeopathy); see a/sq park, supra note 137~ at 578-80 (discrediting homeopathic theory on well-established chemical and mathematical grounds). use of chelation therapy for athero­ sclerosis could be considered both rejected and outmoded in favor ofless toxic therapies. many cam therapies are still undergoing study, while others involving vital energy seem to defy scientific explanation but nonetheless may still be coj:lsidered:reasonable, especially as adjuncts or in the case of health concerns that have proven intractable to other treatment. 168. king, sripra note 133, at 1242-43. . 169. see joseph h. king, jr., reronciling the exercise of judgment and the objeetive standard qjcare in medical malpractice, 52 okla. l. rev; 49, 55 (1999). king discusses allowing variation in practice based on "superior knowledge or special insights," based on . restatement (second) of torts § 289(b). id.. "the actor i~t required to recognize that his ·conduct involve.s a risk of causing an invasion of another's interest if a reasonable man would do so while exercising ... such superior attention, perception, memory, knowledge, intelli­ gence, and judgment as the actor himself has." restatement (second) of torts§ 289(b) 0%~ . . patients with the "saine" illness ~y ~different approaches. based oo a host of individual characteristics. henderson & siliciano, supra note 131, at 1390. varying the customary treatment for a condition based on individual characteristics creates "micro­ customs,'' fragmenting any standard of custom to the degree that it is no longer distinctly discernable. id 2005] complementary and alternative medicine 257 compared."170 the fluidity of this statute offers protection to the cam pro­ vider who is providing a treatment of uncertain efficacy but little risk when the treatment is compared with conventional treatment of uncertain efficacy or high risk. . the federation of state medical boards takes this approach as well. the model guidelines state that "[r]egardless of whether physicians are .using conventional treatments· or cam in their practices, they are responsible for practicing good medicine ... !'171 the model guidelines also recommend a balancing of risks and benefits. in evaluating whether a physician is practicing appropriate medicine, boards should aslc whether the treatment is effective and safe; effective, but with some real or potential dangers; inadequately studied, but safe; or ineffective and dangerous. 172 . under the reasonable physician standard, after finding that a physician's practice was not customary (if relevant) and that a consent document was signed, the inquiry would proceed to whether the practice was nevertheless ·reasonable and prudent under the circumstances. this would entail examining the expertise of physician, health of patient, state of medical knowledge, risk of the treatment, benefit of the treatment, the consent document, and other patient':"specific factors.that may have influenced the choice of treatment. 4. evidentiary concerns rules of evidence have the potential to loom large in cam cases .. the expectation is that evidence poorly supported by scientific literature would be .inadmissible; however, whether this is actually the. case is dependent upon jurisdiction. the role of rules of evidence is well illustrated by medical malpractice cases in pennsylvania over the past dozen years. in gala v. hamilton, a medical malpractice case not involving cam, a divided pennsylvania supreme court held that the ·standard for admissibility must be highly flexible and may consist solely ·of testimonial evidence without support of scientific literature. 173 whether the evidence is sufficient to establish a second school of . thought defense is a matter for the jury.174 · . only four·years previously, the· pennsylvania supreme court in com­ monwealth v. crews had re-affirmed the state court applicability of the united states supreme court's decision in frye v. united states, that "the thing from · which the deduction is made must be sufficiently established to have gained 170. ohio rev. code ann. § 4731.227 (west 2004). 171. model guldblinbs, supra note 80, § i. · 172. id. 173. gala v. hamilton, 715 a2d 1108,1111,1114-15 (penn. 1998). 174. id at 1114-15. 258 indiana health law review [vol. 2:225 general acceptance in the particular field to which it belongs."175 the crews decision occurred shortly after the united states supreme court's decision in daubert v. me"ell dow, which had liberalized the frye rule.176 despite its departure from the supreme court's decisions in both daubert and frye, the pennsylvania supreme court's holding in gala was not necessarily outrage­ ous; the ·conventional wisdom that juries are easily flummoxed by slick experts may be erroneous.117 counterintuitively, rules of evidence requiring scientific proof may in · some cases benefit the defendant cam physician because the plaintiffhas the burden of proof. in the post-daubert case of ballinger v. atkins, a low-carbo­ hydrate diet adherent suffered neurologic complaints which his experts, an internist and a biochemist, attributed to excessive use of artificial sweete­ ners.178 neither expert could adequately support his theory with scientific evidence, so neither was allowed to testify.179 in contrast, the expected outcome did occur in board of registration for the healing arts v. mcdonagh, in which the missouri supreme court grappled with the question of whether frye, daubert, or a missouri statute should apply to admission of scientific evidence in the case of a physician facing discipline for use of edta chelation therapy for vascular disease.180 the court noted that even where the federal rules of evidence and the analogous state provision are "nearly identical," the federal construction is not controlling in state court.181 missouri law required that admissible expert opinion "be based on facts or data of a type reasonably relied upon by 'experts in the field. "'182 the court noted further that: the relevant field must be determined not by the approach a particular doctor chooses to take, but by the standards in the field in which the doctor has chosen to practice. as relevant here, dr. mcdonagh chose to treat patients with vascular . 175. commonwealth v. crews, 640 a.2d 395, 399 (penn. 1994) (quoting frye v. united states, 293 f. 1013, 1014 (d.c. cir. 1923)). . 176. daubert v. meri:ell dow phannaceuticals, inc., 509 u.s. 579, 592-94 (1993) (interpreting federal rules of evidence rule 702 to h'beralize the court's holding in frye, establishing the judge's role as gatekeeperfor expert testimony, and suggesting falsifiability, peer-review and publication, known or potential mte of error and general acceptance as factors in determining admissibility). 177. see also jack w. snyder et al., injury and causation on trial: the phenomenon of "multiple chemical sensitivities,,, 2 widenerl. symp. j. 97, 143-49 (1997) (discussing use of scientific experts, "junk" science, and implications with respect to the supreme court's daubert decision). see generally neil vidmar & shari seidman diamond, juries and expert evidence, 66 brookl. rev. 1121, 1140-65 (2001). 178. ballingerv. atkins, 947 f. supp. 925,926 (e.d. va. 1996). 179. id at 928-29. 180. bd. ofregistmtion for the healing arts v. mcdonagh, 123 s.w.3d 146, 153 (mo. 2003) (en bane). 181. id at 155. 182. id at 156. 2005] complementary and alternative medicine disease. the board's claim is that dr. mcdonagh engaged in repeated negligence ... in his provision of chelation therapy for these patients. therefore, the relevant field is doctors treating persons with vascular disease. 183 259 interestingly, like the pennsylvania supreme court in gala, the missouri court did not require that dr. mcdonagh's experts support their views with scientific literature; however, their evidence was nonetheless inadmissible because it was not of the type that would be reasonably relied upon by doctors treating vascular disease. 184 thus, whether a standard is based on custom or reasonableness, some claims against cam providers may be dismissed because of the impossibility of providing the scientific evidence needed to establish a prima facie case of malpractice. in a much greater number of claims, there may be little admis­ sible evidence for the cam physician (at least in jurisdictions adhering to federal rule construction) given that cam, by definition, is generally not scientifically proven. in other jurisdictions, testimony from cam experts might be excluded, not because it lacks scientific support, but because it is in a sense not relevant from the perspective of the applicable school (as defined by the court). courts may also apply a "flexible" standard, allowing expert testimony unsupported by scientific literature. b. other potential sources of a standard all current methods of arriving at a standard of care rely predominantly on the testimony of experts chosen by the parties. disinterested third parties may also aid in defining the standard. 1. licensing and regulation standard of care can be established through statute; violation of a standard of care mandated by licensing requirements or statute would essen­ tially constitute malpractice per se. absent a statute, professional discipline by a medical licensing board would create a strong inference that a standard of care has been breached if the discipline is tied to the same conduct that led to the malpractice action.185 one such example is charell v. gonzalez, in which a physician treated a terminal cancer patient with coffee enemas and 183. id. 184. id. at 156-57. 185. there is. however, a large measure of circularity in the inference; medical licensing boards may also investigate a physician and revoke the physician's license in response to negligence claims. see glenn e. bradford, the "respectable mmority" doctrine in missouri medical negligence law, 56 j. mo. b; 326, 328 (2000). 260 indiana heal til law review (vol. 2:225 monitored the patient's progress with unproven hair tests.186 the plaintiff's claim asserted first negligence, for the doctor's persuading the plaintiff to forego traditional treatment for treatment of no therapeutic value, and second, lack of informed consent.187 the trial court held for the patient and also awarded punitive damages because the physician had a secondary financial interest in the patient's treatment.188 except for the award of punitive dam­ ages, the decision was upheld on appeal. 189 the year before his case went to trial, the defendant physician, gonzalez, had not prevailed on an appeal of an administrative review board's order that he undergo retraining because while ''the vast majority" of gonzalez' patients had cancer, he "lacked the basic understanding of the disease ... .''190 gonzalez asserted that his patients had all consented to his treatment, and that no. cam practitioners were among the panel reviewing his case.191 the court responded: both the hearing committee and the board recognized that alternative medicine involves a different treatment regime, but held [gonzalez] to the same standard of care to which all physicians in new york are held . . . . notably, 'it is well settled that a patient's oonsent to or even insistence upon a certain treatment does not relieve a physician from the obligation of treating the patient with the usual standard of care.' 192 this standard and the court's view of the physician-patient relationship are reminiscent of those articulated by the north carolina supreme court in in re guess. 193 standard of care through regulation offers the advantage of origin in· a less adversarial environment than the courtroom. · if two apparently incom­ patible concepts must be amalgamated, or one chosen over the other, the infor186. charell v. gonzalez, 660 n.y.s.2d 665, 666 (n.y. sup. ct 1997). 187. id at666-67. 188. ld at 669. 189; charell v. gonzalez, 673 n.y.s.2d 685, 686 (n.y. app. div. 1998). 190. gonzalez v. n.y. state dep't of health, 648 n.y.s.2d 827, 832 (n.y. app. div. 1996). 191. ld. at 830. · 192. id. (quotingmetzlerv. n.y. statebd. forprof'lmed. conduct.203 a.d.2d617, 619 (n.y. app. div. 1994)). 193. in re guess, 393 s.e.2d 833, 839-840 (n.c. 1990). the court noted first that it was within the police power of the state to limit guess' methods of treatment to the acceptable and prevailing standards of medical practice; second, the court declined to recognize a fundamental right for patients to receive unorthodox medical treatment /d. the court concluded that the north carolina legislature ''reasonably believed that a general risk of endangering the public is inherent in any practices which :tail to conform to the standards of'acceptable and prevailing' medical practice in north carolina[,]" regardless whether the public was actually endangered by a particular practice •. id . . at 837. see also discussion supra part u.a.3. · 2005] complementary and alternative medicine 261 mation gathering, debate, and ongoing opportunity to amend the law in response to new infonnation make the legislature a better forum for decision. making. 194 legislative acts or quasi-legislative rules could give deference to minority praetic~ that are innovative, while determining that other minority practices are outmoded or too risk-laden to be justifiable. while detennining standard of care through regulation does offer the advantage of certainty, establishing a standard of care by legislative fiat is likely to create the same sort of professional concern that helling v. carey created when standard of care was imposed by judicial fiat. 195 moreover, the white house commission noted that regulation.through licensure is considered ''not feasible" for some groups such as native american and other traditional healers. 196 other cam practitioners consider themselves outside the realm ofhealth professionals.197 additionally, licensure may stifle the "subjective, interpersonal and intuitive aspects" of cam that make cam valued by its practitioners and patients. 198 from the patient's perspective, regulation may not necessarily be appre­ ciated as protective, but rather perceived as. unwarranted governmental pater194. seepolanyi,supranote64,at66. pojanyiillustrateshowasocietymayresolve"[a] controversy between two fundamentally different views of the same region of experience .... " i d. i can see two main principles underlying the process of free. discussion. one i will call fairness, the other tolerance, the words being used in a somewhat particular sense. fairness in discussion is the effort to put your case objectively. when an expression of our conviction first comes to our minds it is couched in question­ begging terms. emotion breaks out uppermost and permeates our whole idea. to be objective we must sort out facts. opinions, and emotions and present them separately, in this order. this makes it possible for each to be separately checked and criticized. it lay$ our whole position open to our opponent. it is a painful discipline which breaks our prophetic flood and reduces our claims to a minimuin. but fairness requires this; and also that we ascribe our opponent his troe points, while the limitations of our own knowledge and our natural bias be frankly acknowledged. by tolerance i mean here the capacity to listen to an unfair and hostile statement by an opponent in order to discover his sound points as well as the reason for his errors. it is irritating.to open our mind wide to a spate of specious argument on the off-chance of catching a grain of tiuth in it; which, when aclaiowledged, would strengthen our opponent's position and be even unfairly exploited by him against us. it requires great strength of tolerance to go through withthis. · id at 68. this argument is .presented before "[a] judicious public with a quick ear for insin­ cerity of algumcnt .... " . id the candor and selflessness required in this sort of discussioji is inconsistetit with the adversarial process. that some authors have lamented lack oflegislative assistance to cam, while others have claimed legislatures have gone too far in legitimizing cam, suggests that legislatures may be dealing with the issue evenhandedly. . 195. inhellingv. carey, 519p.2d 981.983 (wash.1974), the court imposed a standard ofcarebaseduponreasonableprudencethatwasindependentoftheexperttestimonypresetited· at trial. . . . . . . . 196. white house co~'n, suprq note 4, at 90. · 197. !d. . . 198. id. at 94. 262 indiana health law review [vol. 2:225 nalism.199 other reasonable arguments in opposition to increased regulation of cam include regulations' interference with market mechanisms; the low level of actual urgency of many conditions treated by cam; and· a more permissive attitude of government toward a large number of more dangerous consumer choices.200 in contrast to a regulatory standard, a profession-based standard offers the advantage of being much more responsive to changes in medical know­ ledge. standard of care has changed overnight when a previously respected therapy was unexpectedly found to carry significant risk. 201 determination of standard of care at trial also offers advantages to both plaintiffs and defendants because the particular and probably unique circumstances of the case can be considered. last, legislative determination of a standard may be viewed as an indirect application of the standard of the biomedical experts which advised it, confounded by special interests and politics. compounding the confusion, there is no reason to suppose that state standard of care statutes would be uni­ form from state to state. this may have the effect of decreasing uniformity in medical care and education from state to state. the more direct approach of determination of standard of care by the profession itself obviates these problems. 2. practice guidelines and surveys practice guidelines based on efficacy studies have been useful in. esta­ blishing conventional standards of care and have been available in the past as affirmative malpractice defenses in some jurisdictions.202 practice guidelines are of limited utility when evaluating cam, which, as cam's name suggests, stands in: contraposition to the treatment conformity sought through application of guidelines. moreover, guidelines are developed through compilation of the results of large scientific studies; cam has not yet received this level of scientific scrutiny. 199. holcombe, supra note 78, at 243. 200. id at 243-44. 201. see, e.g., david m. herrington & timothy d. howard, from presumed &me,pt to potentia/harm-hormone therapy and heart disease, 349 (6) new eng. j.mbd. 519 (2003); david m. herrington, hormone replacement therapy and heart disease: replacing dogma with data, 107 circulation 2 (2003). epidemiologic data showed that hormone replacement therapy, prescribed for many post-menopausal women and for years believed to be beneficial, conferred an increased risk of mortality. the resulting turnabout in treatment recommendation received national lay media attention; see red flag on hormone replacement, cbsnews .com, july 9, 2002, at http:/lwww.cbsnews.com/stories/2002/07/09/healthlmain514513.shtml (last visited apr. 18, 2005) (on file with the indiana health law review); see also, e.g., a/eve newest drug linked to risk, cbsnews.com, dec. 21, 2004, at http://www.cbsnews.com/ stories/2004/12/07/health/main659540.shtml (last visited apr. 18, 2005) (on file with the indiana health law review) (discussing recent findings that some commonly prescribed anti· inflammatory medications increase risk of heart attack). 202. see, e.g., me. rev. stat. ann. tit. 24, §§ 2971-78 (west, repealed 1999). 2005] complementary and alternative medicine 263 an additional problem in the application of guidelines comes from cam's "exceedingly complex mosaic of ... practices, therapies, modalities; disciplines;.and professions .... "203 although some practices such as chiro­ practics have extensive education and training standards, many other cam therapies are only just developing any sort of uniform educational or accredi­ tation standards. 204 variations in state licensing requirements and scope of practice regulations cause cam practices with the same or similar titles, to. vary from state to state. 205 standardized education, licensure requirements, and scope of practice regulations would seem to be a necessary precursor to development of treatment guidelines for cam. surveys of physicians used to establish a standard of care, when the results are presented by experts, have been admissible in court; however, random sampling may not find doctors familiar with cam, and the technique has recognized drawbacks when applied to minority views.206 c. policy-tossing a spanner into the works legislatures may base decisions to limit or to expand the varieties of licensed medical practices upon popular demand207 or other policy grounds even in the face of strong scientific evidence disfavoring the law. court deci­ sions as well may run contrary to the result urged by science, basing a holding upon legislative intent or non-science-based policy. for example, edta has been approved by the fda for use in some heavy metal intoxication but not for treatment of atherosclerosis. 208 in a case questioning whether a physician may use edta to treat atherosclerosis, the fifth circuit court of appeals in united states v. evers looked to legislative intent to conclude "the regulations of the fdathat are now in force do not prevent [a physician] from prescribing for uses not approved by the fda drugs 203. white house comm'n, supra note 4, at 63. 204.jd. 205. id. at 75. 206. see tim cramm et al., ascertaining customary care in malpractice cases: asking those who know, 37 wake forest l. rev. 699, 745-46 (2002). 207. polanyi, supra note 64, at 69. polanyi descn'bes the potential role of politics in scientific decision·making: [t]he public ... [generally] accepts, or rejects, the opinion 'of science' or the teachings 'of religion' in their entiretywithouttryingto discriminate between the views of different scientists or of different theologians. yet occasionally they will intervene even in the internal question of one or the other great domain of the mind, particularly where an altogether new point of view is in rebellion against the ruling orthodoxy. . . • the rise to scientific recognition in our own time of psycho-analysis, manipulative surgery, and most recently of telepathy, owe much to popular support. ... /d. more pointedly, "[i]n fields wh~ scientific criteria allow wide latitude of judgment (e.g. medicine, agricultural science, or psychology) the crank who can enlist political support will find easy openings for establishing himself in a scientific' position." id at 79. 208. united states v. evers, 643 f.2d 1043, 1047 (5th cir. 1981). 264 indiana health law review [vol. 2:225 ·which have been approved by the fda for some other purpose. "209 rather than addressing the case from a scientifically justified consumer protection standpoint, 210 the court looked to legislative history and adopted congress' rationale, approaching the case from the policy standpoint of not interfering . with the physician-patient relationship: [t]here were repeated statements that congress did not intend · the food and drug administration to interfere with medical practice and references to the understanding-that the bill did not purport to regulate the practice of medicine as between the physician and the patient. congress recognized a patient's right to seek civil damages in the courts if there should be evidence of malpractice, and declined to provide any legislative restrictions upon the medical profession.211 thus, a physician may use fda approved medications in an unapproved manner at the physician's (and perhaps patient's) peril, with an understanding that authorization to use th~ medications in an unapproved manner does not immunize the physician from malpractice claims if the standard of care is violated. similarly, in state board of medical examiners v. ·rogers, the florida supreme court held that a physician may use edta for chelation therapy, reasoning that the restraint of the use of edta "was an arbitrary and unrea­ sonable exercise of the state's police power. "212 the court overruled the board of medical-examiners, which had found that edta "chelation therapy can best be classified as investigational, that it more likely can be classified as quackery, and that its use outside a controlled environment such as a research institute fails to conform to acceptable and prevailing medical practice."213 in 1989, the fda listed edt a treatmentasoneofthenation's "top 10 health frauds," lending additional credence to the medical boards' stance in evers and rogers.214 nevertheless, iri the case of edt a, non-malpractice common law and statutory construction have permitted broader use than had been considered within the standard of care as determined by the medical pro­ fession and, later, the fda itself. even with the fda's opinion backing them, 209. id. at 1049. 210. ld. at 1048. at dr. evers' trial, "[t]hree physicians testified that several deaths had been caused by dr. evers' use of chelation therapy, and the court concluded that the doctor's practices were indeed a serious danger." id. at 1045. 211. id. at 1048 (quoting letter from the acting director of the office of scientific evaluation of the bureau ofdru~ (march 7, 1974)). 212. statebd. ofmed. exam'rsv. rogers, 387 so. 2d937; 937,940 (fla.l980). this case illustrates the danger-of applying. the analysis that one would expect to be applicable in a medical malpractice case to licensing or phannaceuti.cal use cases. · · 213. id. at 939; . . . · · . . .. · · 2i4. top johea/thfrauds,23 fdaconsumer29,31 (oct.1989) . . ·· 2005] complementary and alternative medicine 265 medical boards may remain unable to enforce a standard of care with respect to edta so long as edta has approved uses. while violating a specific statutory prohibition creates a reasonable inference of a violation of the standard of care, failing to limit treatments to those approved by the fda and medical licensing boards creates a weaker inference. v. conclusion malpractice claims involving cam challenge the use of custom in deter­ mining standard of care. requiring adherence to custom has the theoretical effect of making the practice of cam a per se breach of the standard of care. patient autonomy; preservation of valuable cultural practices, and existence of other avenues for consumer protection present compelling arguments that the inevitability of this result is undesirable and that an alternative to custom should be sought. whatever the standard of care formulation, a decision to approve cam practices necessarily entails a decision to reject a purely scientific basis for treatment. the reasonable and prudent physician standard offers an alternative to custom without the fatal flaws of other standard of care formulations. the standard is also consistent with the trend of state tort law toward application of a professional reasonableness standard rather than a customary practice standard. because standard of care may differ depending on whether reasonable­ ness is defined from the perspective of biomedicine or cam, any offering of cam should be accompanied by augmented informed consent that expressly documents whether treatment will be biomedical or cam, that sets the expec­ tations of both physician and patient, and that identifies risks of obtaining and foregoing both cam and biomedical treatments. absent informed consent, the reasonable treatment should be presumed to be biomedical, for without justification, there would be no reason to offer a treatment that has not been proven safe and efficacious. informed consent for cam should be more in the nature of a contract than typical informed consent, and should be crucial to definition of the physician's duty. because such a contract is unlikely to be boilerplate, the reasonableness standard based on duties defined in this contract would be patient-specific. the boundaries of permissible care can be defined by legislatures and may co-exist with a reasonableness standard. this approach offers the advant­ ages of certainty and origin in a less adversarial environment than the courts, but has the disadvantages of slow response to innovation and a high likelihood of state to state variability. adoption of the model guidelines and other mea­ sures to increase uniformity in education and licensure requirements can remedy these issues. states may also protect consumers by adoption of informed consent templates or guidelines for cam practices. . . . . '. harvesting organs from minors and incompetent adults to supply the nation's organ drought: a critical review of the substituted judgment doctrine and the best interest standard beth a. schenberg • table of contents i. introduction •.•.......... ., ................................................................ 320 ii. the history of organ donation ...................................................... 322 iii. the constitutional rights of minors and incompetent adults regarding medical decisions .................................... 323 n. the constitutional conflict between parental rights. and the parens patriae power of the state ......................... 324 v. an introduction to two standards: the substituted judgment doctrine and the best interest approach ......... 327 a. the substituted judgment doctrine ......................................... 327 1. the early years of the substituted judgment doctrine ..... 328 2. modern application of the substituted judgment doctrine ............................................................................. 330 3. endorsements, evaluations, and criticisms of the substituted judgment doctrine .......................................... 332 b. the best interest standard ....................................................... 336 1. the best interest standard and the use of psychological benefits .............................................................................. 337 2. application of the best interest standard and the use of psychological benefits ....................................................... 338 3. endorsements, evaluations, and criticism of the best interest standard ............................................................................ 342 vi. policy concerns related to harvesting organs and tissue from minors and incompetent adults ................................... 344 a. no duty to rescue tort law principles ................................... 344 b. the right to bodily integrity .................................................... 346 c. using the fetus as an organ farm .......................................... 348 vii. proposed solution: anendtodualstandards ................. 350 a. procedural requirements ......................................................... 351 1. courts should scrutinize any decision coming from a parent or guardian ........................................................... 351 • j.d., 2006, indiana university school oflaw, indianapolis, indiana; b.s. in business, 2003, miami university, oxford, ohio. 320 indiana healtif law review [vol. 4:319 2. the adversarial process should be used in all cases ...... 352 3. courts should review petitions only if no reasonable medical alternative exists ................................................. 353 b. the standard for formerly competent adults ......................... 353 c. the standard for minors and never-before-competent incompetent adults .................................................................. 355 1. the donor's expressed preference ................................... 355 2. physical benefit and harm associated with the harvest ... 356 3. psychological benefit and harm associated with the harvest .............................................................................. 356 4. the recipient is likely to benefit from the transplant.. ... 358 5. the potential donor and potential recipient have an existing relationship ......................................................... 358 viii. conclusion ................................................................................... 359 i. introduction in 1990, a california couple, desperate to find a bone marrow donor for their seventeen-year-old daughter, conceived another child in hopes of produc­ ing a suitable donor. 1 when the infant was only thirteen months, a bone mar­ row transplant was performed? due to the difference in physical size between the infant and the seventeen-year-old daughter, the infant had to undergo multi­ ple harvesting procedures.3 a greater amount of bone marrow had to be har­ vested due to the disproportionate sizes ofthe siblings.4 the physical risks associated with harvesting bone marrow from an infant, as well as the psycho­ logical harm the conceived child may experience later in life, are just a few rea­ sons why many critics believe parents should not be permitted to consent to their child's medical treatment, specifically when the parents are acting as deci­ sion-makers for both the donor child and the child recipient. a similar argu­ ment is made when the guardian of an incompetent adult acts as a decision­ maker but is in the same way faced with conflicting interests. while it has long been accepted that competent adults have the right to exercise control over their bodies and choose whether to donate an organ, the situation is not the same for children and incompetent adults. prior to the nine­ teenth century, children in the united states were regarded as the chattel of their fathers and wards of the state.5 as such, children did not possess rights 1 abigail trafford, brave new reasons for mothering; having a baby to produce a potential organ donor, wash. post, feb. 27, 1990, at z6; see sally ann stewart, toddler may be sister's lifesaver, usa today, june 4, 1991, at 3a. 2 trafford, supra note 2; see stewart, supra note 2. 3 trafford, supra note 2; see stewart, supra note 2. 4 trafford, supra note 2; see stewart, supra note 2. 5 marvin r. ventrell, rights & duties: an overview of the attorney-child client rela2007] harvesting organs from minors and incompetent adults 321 independent oftheir parents, but rather, the law focused on the rights of adults with respect to their children. 6 during this time, courts refrained from interfer­ ing with the familial relationship because parental control and custody were considered a sacred right. 7 subsequently, social reformers initiated a movement to protect children, believing that children needed to be rescued from the "ef­ fects ofthe industrial revolution.',s since this time, however, children's rights have developed gradually with the state's recognition of parens patriae power.9 although courts no longer view children as their parent's chattel, children, as well as incompetent adults, do not maintain the full panoply of constitutional rights that are extended to adults. 10 this does not mean, however, that children and incompetent adults do not possess any rights under the united states con­ stitution. for example, the supreme court has held that, like adults, the consti­ tution generally protects children against governmental deprivations. 11 furthermore, the supreme court has extended the right of privacy in decision­ making contexts to include minors.12 in bellotti v. baird, however, the su­ preme court stated three reasons to justify its conclusion that children do not possess constitutional rights identical to those of an adult: (1) "the peculiar vul­ nerability of children;" (2) ''their inability to make critical decisions in an in­ formed, mature manner;" and (3) "the importance of the parental role in child rearing."13 the court's reasoning has been similarly used to justify why in­ competent adults, like children, do not possess rights identical to competent adults. 14 while not completely devoid of all constitutional rights, it is clear that minors and incompetent adults are not able to exercise certain rights without the assistance of a parent, guardian, or the court.15 this note discusses the many legal, ethical, and moral dilemmas pre­ sented by the practice of compelled live organ donation as used with minors tionship, 26 loy. u. cm. l.j. 259, 261 (1995). 6 !d. 7 see rachel m. dufault, comment, bone marrow donations by children: rethinking the legal framework in light ofcurran v. bosze, 24 conn. l. rev. 211,213-14 (1991). 8 ventrell, supra note 6. 9 !d. for further discussion of the state's parens patriae power, see infra parts ill, iv. 10 bryan shartle, comment, proposed legislation for safely regulating the increasing number of living organ and tissue donations by minors, 61 la. l. rev. 433,439 (2001). 11 see goss v. lopez, 419 u.s. 565 (1975) (holding that the fourteenth amendment protected students suspended without a prior hearing from such "arbitrary deprivations oflib­ erty" as unilateral suspensions of up to ten days without notice and hearing). 12 see planned parenthood of cent. mo. v. danforth, 428 u.s. 52 (1976) (holding that the state could not impose a blanket requirement for doctors to obtain consent to abortion for minors during the first trimester). 13 bellotti v. baird, 443 u.s. 622, 634 (1979). 14 see superintendent of belchertown state sch. v. saikewicz, 370 n.e.2d 417,425 (mass. 1977); godwin v. state, 593 so. 2d 211, 261 (fla. 1992). 15 see bonnerv. moran, 126 f.2d 121, 122 (d.c. cir. 194l)("generallyspeaking, the rule has been considered to be that a surgeon has no legal right to operate upon a child without the consent of his parents or guardian."); in re conroy, 486 a.2d 1209, 1230 (n.j. 1985); du­ fault, supra note 8, at 216. 322 indiana healrn law review [vol. 4:319 and mentally incompetent individuals. 16 it reviews and rejects both the substi­ tuted judgment doctrine and the best interest standard and proposes a new ap­ proach to assist judges, parents and guardians, and medical professionals in determining when it is appropriate for minors and incompetent adults to serve as organ and tissue donors. part ii of this note addresses the history of organ donation and the development oflive organ and tissue donation within the last fifty years. part iii discusses the evolution of minors' and incompetent adults' constitutional rights pertaining to medical treatment. part n examines the con­ flict between the state's parens patriae power and the constitutional right to family autonomy. although supreme court decisions have long recognized deference to parental control, this note suggests that the right to family auton­ omy must be balanced against the state's interest in protecting individuals who are unable to protect themselves. part v focuses on the two standards a court uses to determine whether to permit an organ or tissue harvest from a minor or incompetent adult. in analyzing the substituted judgment doctrine and the best interest approach, this note addresses the modern application of the standards as well as the praise and criticism both approaches receive. part vi of this note illustrates the policy and social concerns raised with harvesting organs from minor and incompetent adults. finally, part vii of this note proposes a solu­ tion that will resolve the debate regarding which standard is more appropriate. this note recommends that the court take different approaches when individu­ als have been competent once before and when individuals have never before been competent. furthermore, the court may take into account psychological factors, such as the need to avoid psychological distress associated with the death of a sibling. not only does this new standard protect the interests of the donor, but also, it preserves and respects the donor's personal autonomy. ii. the history of organ donation each year, thousands of individuals voluntarily donate organs and tissue for the pure altruistic benefit of saving another's life. 17 despite this selfless act, the supply from donors simply cannot keep pace with the demand, and unfortu­ nately, thousands die while waiting on a recipient list. 18 given the overwhelm16 this note does not discuss issues regarding persons in a persistent vegetative state. for an interesting article discussing organ harvests from individuals in a persistent vegetative state, see john b. oldershaw et al., persistent vegetative state: medical, ethical, religious, economic and legal perspectives, 1 depaul j. health carel. 495 ( 1997). 17 organ procurement & transpiantationne1work& the scientific registry of transplant recipients, annual report iii-1 (2004) [hereinafter "organ procurement & transplant ne1work 2004j. the data and analyses reported in the 2004 annual report of the u.s. organ procurement and transplantation network and the scientific registry oftrans­ plant recipients have been supplied by unos and arbor research under contract with hhs. id. the authors alone are responsible for reporting and interpreting these data. ld. 18 organ procurement & transplantationne1work& the scientific registry of 2007} harvesting organs from minors and incompetent adults 323 ing demand for organs and tissue, doctors and researchers began to seek alter­ native sources for donors.19 with the first successful kidney transplant involving a live donor occur­ ring in 1954, live donors, as opposed to cadaver donors, have become an in­ valuable resource?0 in fact, in 2000, the number ofliving donors exceeded the number of cadaver donors.21 the trend continued from 2001 to 2003.22 in 2004, however, the number of living donors fell below the number of deceased donors.23 despite this annual decline, live donors continue to be a critical source of transplantable organs, helping to relieve the nation's shortage of or­ gans and tissue. 24 though demand for organs and tissue is alarming, many commentators believe that using minors and incompetent individuals as a means to increase the supply is simply not justified. every year, organs are harvested from minors and mentally incompetent adults who neither voluntarily donate their organs nor consent to the surgical procedure. iii. the constitutional rights of minors and incompetent adults regarding medical decisions since medical decisions are so important and because procedures are so often permanent, decisions regarding the type of medical treatment received by minors and incompetent adults are typically determined by parents, guardians, and courts. 25 whereas minors have been extended some authority to consent to medical treatment, the right to consent to nontherapeutic medical procedures, such as live organ and tissue donations, does not fall within their authority.26 minors and incompetent adults cannot consent to nontherapeutic procedures, transplant recipients, annual report 1-l (2005) [hereinafter "organ procurement & transplant network 2005"]. in 2004, just over 7,300 patients died while waiting for a trans­ plant. id. while this number increased from 2003, the number of recipients on the waiting list also increased from 2003. jd. thus, the overall death rate did decline slightly. !d. 19 shartle, supra note 11, at 433. 20 organ procurement & transplantation network, facts about living donation, http://www.optn.org/about/donationllivingdonation.asp (last visited mar. 27, 2007). 21 organ procurement & transplantnetwork2005, supra note 19. 22 id. 23 id. ofthe 14,154 organs donated in the united states in 2004,7,152 were from de· ceased donors compared to only 7,002 from living organ donors. id. even though the actual number ofliving donors increased three percent from 2003, this increase was a smaller annual rate than in recent years. jd. furthermore, fourteen percent of deceased donors in 2004 were under the age of seventeen. id. at iv -3. 24 shartle, supra note 11, at 434. 25 lawrence p. wilkins, children's rights: removing the parental consent barrier to medical treatment of minors, 1975 ariz. st. l.j. 31, 31 (1975). 26 see hart v. brown, 289 a.2d 386,391 (conn. super. ct.1972)(statingthatbonnerv. moran, 126 f.2d 121 (d.c. cir. 1941), is the legal authority for permitting non-therapeutic procedures to be performed on minors as long as the parents or guardians consent); shartle, supra note 11, at 443. 324 indiana health law review [vol. 4:319 such as organ donation, due to the presumption that a minor or an incompetent adult is too inexperienced, cannot adequately assess the situation, and arguably lacks the ability to comprehend fully the consequences of his or her decision. 27 in his writings on the concept of individual liberty, john stuart mill dis­ cussed his belief that children should not possess the ultimate value of personal choice due to their inability to act for the betterment ofsociety.28 it was mill's belief that ''the need to maximize overall goodness in society dictate[ d] that children, unlike adults, should not be permitted the right to interpret their own good, for fear they [would] not act in accordance with the public good. "29 in such a case, a surrogate decision-maker makes these medical decisions for the minor or incompetent adult the law requires that the surrogate decision-maker ensure that liberty interests of the minor or incompetent adult are both protected and respected. 30 the appropriateness of parental or guardian consent is less clear when the medical treatment for the minor or incompetent adult is unnecessary. 31 when the person benefiting from the treatment is not the minor or incompetent adult but is instead a third party, the surrogate decision-maker may no longer be act­ ing solely with the minor's or incompetent adult's interests in mind.32 in order to expose any conflict of interest that a parent or guardian may have, courts must be used as the avenue for transplants. 33 accordingly, with respect to or­ gan donation, courts scrutinize consent for a transplant coming from a parent or guardian. 34 iv. the constitutional conflict between parental rights and the parens patriae power of the state given its intimate nature and the great weight society places on privacy and family integrity, family autonomy has long been recognized by united states courts. throughout the twentieth century, the supreme court has held 27 bonner, 126 f.2d at 122; see shartle, supra note 11, at 439-40. 28 victor l. worsfold, a philosophical justification for children's rights, in the righfs of children29, 32 (harvard educational review 1974) (discussingjohns1uartmnl. on liber1y (1963)). 29 /d. at33. 30 see in rea. c., 573 a.2d 1235, 1249 (d.c. 1990); in re nancy ellen jobes, 529 a.2d 434, 436-37 (n.j. 1987) ("[t]he goal of a surrogate decision-maker for an incompetent patient must be to determine and effectuate what that patient, if competent, would want"); shartle, supra note 11, at 441. 31 see hart, 289 a.2d 386; cara cheyette, organ harvests from the legally incompe­ tent: an argument against compelled altruism, 41 b.c. l. rev. 465,466 (2000). 32 this situation may arise, for example, when a parent or guardian wishes to harvest an organ from a minor or an incompetent adult in order to save the life of a sibling. 33 janet b. korins, curran v. bosze: toward a clear standard for authorizing kidney and bone marrow transplants between minor siblings, 16 vr. l. rev. 499,505 (1992). 34 id. at 503. 2007] harvesting organs from minors and incompetent adults 325 that the fourteenth amendment grants parents the constitutional right to control the education, rearing, and upbringing of their children.35 not only is deference to parental control "deeply rooted in our nation's history and tradition,"36 but also, there are continuing interests advanced in providing deference to this no­ tion. the state has an ongoing interest in providing and protecting family au­ tonomy because it "prepar[ es] children to become productive members of society, develop[ s] religious and cultural diversity among citizens, and fulfill[ s] support obligations that would otherwise fall to the state.'m furthermore, the law's concept of"family'' sustains the idea that parents and guardians possess the skills, life experiences, and capabilities to take on life's more demanding decisionsall characteristics that a child or incompetent adult lacks. 38 finally, and perhaps most controversial, is the presumption that "natural bonds of affec­ tion" will prevent parents or guardians from acting contrary to the "best inter­ ests of their children. "39 due to the tremendous regard family autonomy retains, state intervention is justifiable only when "a powerful countervailing interest" has been demon­ strated.40 similarly derived from the fourteenth amendment and included in this "freedom of personal choice in matters of family life,'""1 is a parent or guar­ dian's right to make important decisions regarding medical treatment.42 as a general rule, parents and guardians hold awesome authority to establish medical care for their ward "even when the decision might impinge on a liberty interest. ,,43 35 wisconsin v. yoder, 406 u.s. 205,234 (1972); piercev. soc'yofsisters, 268 u.s. 510, 534-35 (1925); meyer v. nebraska, 262 u.s. 390, 399 (1923) ("[liberty d]enotes not merely freedom from bodily restraint but also the right of the individual to contract, to engage in any of the common occupations oflife, to acquire useful knowledge, to marry, establish a home and bring up children, to worship god according to the dictates ofhis own conscience, and gen­ erally to enjoy those privileges long recognized at common law as essential to the orderly pur­ suit ofhappiness by free men."). 36 bellotti v. baird, 443 u.s. 622, 638 (1978). 37 daniel b. griffith, the best interests standard: a comparison of the state's parens patriae authority and judicial oversight in best interests determinations for children and incompetent patients, 7 issues l. & med. 283,289 (1991). 38 parham v. j.r., 442 u.s. 584,602 (1979). 39 id. 40 stanley v. illinois, 405 u.s. 645, 651 (1972). 41 santoskyv. kramer, 455 u.s. 745,753 (1982). 42 in rebabyk., 832 f. supp. 1022,1030(e.d. va.1993);seesusand.hawkins,pro­ tecting the rights and interests of competent minors in litigated medical treatment disputes, 64 fordham l. rev. 2075,2081-82 (1996). 43 baby k., 832 f. supp. at 1030. the parents disagreedoverwhethertocontinuemedi­ cal treatment for their anecephalic daughter who was on a ventilator. id. after discussing the significant united states supreme court cases that protect a parent's fourteenth amendment right to bring up a child, the court held that "(t]hese constitutional principles extend to the right of parents to make medical treatment decisions for their minor children •... even when the decision might impinge on a liberty interest of the child." !d. for cases discussing a parent's 326 indiana health law review [vol. 4:319 although it appears limitless, this right to familial privacy and parental control is not absolute. the right to family autonomy must be balanced against the state's parens patriae power. the doctrine of parens patriae power, originat­ ing in england, illustrates the relationship between the states and its citizens.44 the crown applied this principle to protect those individuals who could not protect themselves. 45 courts in the united states similarly invoke this power in order to protect persons who are unable to protect themselves. 46 thus, state intervention in private relationships is permitted in order to promote the best interests of persons in need of such protection. 47 however, just as the right to familial privacy and parental control is not absolute, the state's power faces similar restraints. the state's parens patriae power is limited to the extent that the state is required to act solely for the best interests of the child.48 while it is clear that the state's power and parental control are frequently at odds, 49 it is less apparent how the power struggle should be resolved. on more than one occasion, the supreme court has expressed its reluctance to in­ terfere with matters concerning familial decisions. 50 at the same time, the court has not shied away from placing limits on parental authority. for exam­ ple, in prince v. massachusetts, the court acknowledged that "the custody, care and nurture of the child reside first in the parents.'.s1 the court reaffirmed, "the state can neither supply nor hinder" this freedom. 52 the court, however, subsequently limited this parental authority when it declared, "(p ]arents may be free to become martyrs themselves. but it does not follow they are free, in constitutionally protected right to raise a child free from governmental intrusion, see parham, 442 u.s. at604; wisconsin v. yoder,406 u.s. 205,205 (1972); princev. massachusetts, 321 u.s. 158 (1944); pierce v. soc'yofsisters, 268 u.s. 510,510 (1925); meyerv. nebraska, 262 u.s. 390,390 (1923) 44 united states v. cohen, 733 f.2d 128, 152n.2l (d.c. cir.l984);see0riffith,supra note 37, at 287. parens patriae translates to "father of his country." cohen, 733 f.2d at 152 n.21. 45 cohen, 733 f.2d at 152 n.21; see griffith, supra note 38, at297. 46 in addington v. texas, the supreme court stated that the "[s]tate has a legitimate interest under its parens patriae [sic] powers in providing care to its citizens who are unable because of emotional disorders to care for themselves." addington v. texas, 441 u.s. 418, 426 (1979); see also hellerv. doe, 509 u.s. 312,332 (1993)(quotingaddington, 441 u.s. at426) ("(t]he state also has ..• authority under its police power to protect the community from the dangerous tendencies of some who are mentally ill."); in re e.g., 549 n.e.2d 322, 327 (ill. 1989). 47 hawkins, supra note 43, at 2084. an individual whose physical or mental well-being is at risk is an example of a person in need of such protection. 48 see pierce, 268 u.s. at 510; griffith, supra note 38, at 290. 49 for examples of the state's parens patriae power at odds with parental rights, see wis­ consin v. yoder, 406 u.s. 205, 234 (1972); pierce, 268 u.s. at 534-35; meyer v. nebraska, 262 u.s. 390,400-01 (1923). so see yoder, 406 u.s. 205; prince, 321 u.s. 158; pierce, 268 u.s. 510; meyer, 262 u.s. 390. 51 prince, 321 u.s. at 166 (citing pierce, 268 u.s. at 510). s2 id. 2007] harvesting organs from minors and incompetent adults 327 identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves."53 thus, the state's power to limit parental or guardian control re­ garding actions affecting the welfare of a child or incompetent adult is justified by society's interest in protecting the well-being of the child or incompetent adult. it is this power struggle between family autonomy and the state's parens patriae power that causes commentators to debate whether parental consent is sufficient for a child or incompetent adult to donate an organ or tissue for the benefit of a third party. 54 v. an introduction to two standards: the substituted judgment doctrine and 1he best interest approach when faced with a petition from parents or guardians requesting authori­ zation for organ and tissue donations from minors or incompetent adults, the united states uses a common law approach. 55 accordingly, the power to adju­ dicate the petition for the compelled donation lies in the hands of the judici­ ary.56 courts have applied one of two judicial standards when presented with such cases: (1) the substituted judgment doctrine and (2) the best interest stan­ dard. although both standards may result in the same outcome, ''the distinction between the two approaches is not merely semantic. "57 some courts use the substituted judgment approach because it is more flexible and deferential to individual autonomy. 58 on the other hand, many other courts choose to apply the best interest standard due to its paternalistic approach. 59 regardless of the standard applied, each approach raises fascinating concerns, faces immense criticism, and offers compelling support for why it is superior to the alternative. a. the substituted judgment doctrine beginning it its earliest form, the substituted judgment doctrine was used as a way of allocating the estate of an incompetent individual. 60 today, courts 53 id. at 170; see also schall v. martin, 467 u.s. 253, 265 (1984) ("[children] are as­ sumed to be subject to the control of their parents, and if parental control falters, the state must play its part as parens patriae."). 54 jennifer k. robbennolt et al., advancing the rights of children and adolescents to be altruistic: bone marrow donation by minors, 9j.l. & realm 213,218 (1994-1995). 55 shartle, supra note 11, at 44 7. although the uniform anatomical gift act, which governs cadaver donations, has been enacted in every state, no state has yet to enact legislation that regulates petitions for live organ donations. id. 56 /d. at 448. 57 dufault, supra note 8, at 212. 58 see paull. liacos,/s "substituted judgment" a valid legal concept?, 5 issufsl.& med. 215,220 (1989). 59 dufault, supra note 8, at 212. 60 see ex parte whitbread, 35 eng. rep. 878 (1816); in re boyd, 403 a.2d 744, 749 328 indiana health law review [vol. 4:319 continue to rely on the substituted judgment doctrine as a means of determining what the minor or incompetent adult would do ifhe or she was in fact compe­ tent. 61 over the years, proponents and critics of the doctrine have debated its appropriateness in medical conte:k.ts. yet despite these praises and critiques, the substituted judgment doctrine has been transformed into a revolutionary stan­ dard applied in a wide variety of contexts. 1. the early years of the substituted judgment doctrine the substituted judgment doctrine was originally enacted by english courts during the nineteenth century. 62 it was first applied in the area of estate administration of mentally incompetent persons. 63 in 1844, the substituted judgment doctrine found its way into the united states, when a court of equity handled the property of a mentally incompetent person as it believed the person would have acted if competent. 64 evidence of previous gift giving and state­ ments regarding an incompetent adult's intentions were admissible so as to bet­ ter assist the court in determining what the incompetent person would do if competent. 65 in its original form, this subjective test was a means of making allowances from the income of a person who was once competent (but now mentally incompetent) by looking at the person's prior conduct and intent. 66 eventually, courts began to apply this doctrine to medical decision-making cas­ es. the substituted judgment doctrine has rapidly evolved from its early years to become a comprehensive standard utilized in cases involving organ dona­ tions,67 ''right to die" cases,68 and religious-based objections to medical treat­ ment cases.69 (d.c. 1979); strunk v. strunk, 445 s.w.2d 145, 147-48 (ky. 1969); superintendent ofbelcher­ town state sch. v. saikewicz, 370 n.e.2d 417,431 (mass. 1977). 61 see cruzan v. dir., mo. dep't. ofhealth, 497 u.s. 261,271 (1990); see little v. lit­ tle, 576 s. w .2d 493, 497 {tex. app. 1979); saikewicz, 370 n.e.2d at 431; strunk, 445 s. w.2d at 148. 62 see whitbread, 35 eng. rep. 878; boyd, 403 a.2d at 749; saikewicz, 370 n.e.2d at 431; strunk, 445 s.w.2d at 148. 63 see whitbread, 35 eng. rep. 878; boyd, 403 a.2d at 749; saikewicz, 370 n.e.2d at 431; strunk, 445 s.w.2d at 148. 64 in re willoughby, 11 paige cb. 257, 259 (n.y. cb. 1844) (''[a court of equity could act] for the lunatic, and in reference to his estate, as it supposes the lunatic himself would have acted if he had been of sound mind.''); see louise harmon, falling off the legal vine: legal fictions and the doctrine of substituted judgment, 100 yalew. 1, 26 (1990). 65 see willoughby, 11 paige ch. at 259; harmon, supra note 65, at 24-29. 66 robert w. griner, live organ donations between siblings and the best interest stan­ dard: timeforstricterjudicial intervention, 10 ga. st. u. l. rev. 589,591 (1994). 67 see, e.g., hart v. brown, 289 a2d 386, 386 (conn. super. ct. 1972); strunk, 445 s.w.2d 145; little v. little, 576 s.w.2d 493, 493 {tex. app. 1979). 68 see, e.g., gray v. romeo, 697 f. supp. 580, 584 (d.r.i. 1988); in re nancy ellen jobes, 529 a2d 434, 434 (n.j. 1987). 69 see, e.g., in re boyd, 403 a.2d 744 (d.c. 1979); giles r. scofield, getting down to cases, 7 issues l. & med. 213, 213 (1991). 2007] harvesting organs from minors and incompetent adults 329 under the doctrine of substituted judgment, the fact finder makes a sub­ jective determination of what a minor or an incompetent person would want when faced with the same decision. 70 "the doctrine is based on the principle that a court will not refuse to act if it is probable that the incompetent would have taken the same action had he been normal.'.n courts purport to "deter­ mine and effectuate, insofar as possible, the decision that the patient would have made if competent. ideally, both aspects of the patient's right to bodily integritythe right to consent to medical intervention and the right to refuse it should be respected.'.n additionally, the court makes every effort to "don the mental mantle of the incompetent."73 courts attempt to make this determina­ tion based on the behavior and statements made during a competent period of that person's life and the value system of the patient and the patient's family. 74 some courts also look at what the majority of persons would do in similar cir­ cumstances 75 and substitute its judgment for that of an incompetent adult based on a person's previous desire to minimize estate taxes, motives of charity, orfor purely selfish reasons. 76 the justification for applying the substituted judgment doctrine is that it provides minors and incompetent individuals ''the same panoply of rights and choices [the state] recognizes in competent persons. "77 this doctrine is further justified on the basis that the incompetent person will likely ratify the decision in the chance that he or she recovers. 78 moreover, courts will not rely upon whether a benefit to the child or in­ competent adult exists. 79 in fact, assuming that the decision is based on the minor's or incompetent person's personal preferences, the substituted judgment doctrine permits the court to make decisions that may be contrary to the minor 70 little, 516 s.w.2dat497. 71 id. 72 in re conroy, 486 a.2d 1209, 1229 (n.j. 1985). 73 superintendent of belchertown state sch. v. saikewicz. 370 n .e.2d 417, 431 (mass. 1977) (quoting in re carson, 39 misc. 2d 544, 545). 74 robbennolt, supra note 55, at 220-21. for example, if the incompetent person, while competent, made gifts or expressed some intention to act gratuitously, courts have only rarely refused to substitute its judgment for that of the incompetent adult. john a. robertson, organ donations by incompetents and the substituted judgment doctrine, 16 colum. l. rev. 48, 5960 (1976) [hereinafter robertson, organ donations]. courts assume that, if competent, the incompetent person would have made the gift. id. at 60. 75 scofield, supra note 70. 76 see in re dupont, 194 a.2d 309 (del. ch. 1963); in re flagler, 162 n.e. 471 (n.y. 1928); ex parte whitbread, 35 eng. rep. 878 (1816). 77 saikewicz, 370 n.e.2d at 428. 78 see whitbread, 35 eng. rep. 878. courts presume that if the incompetent person recovers, he or she will not blame the guardian for carrying out an act based on a pattern estab­ lished by the incompetent person while he or she was competent. robertson, organ donations, supra note 75, at 60. 79 shartle, supra note 11, at 448. 330 indiana health law review [vol. 4:319 or incompetent person's best interests. 80 respect for persons requires that the choice the incompetent individual would make, ifhe or she were competent or a fully matured adult, has priority over any conflict with the incompetent indi­ vidual's best interests.81 it is the subjective personal preferences of the minor or incompetent adult that controls the court's decision-making authority.82 2. modern application of the substituted judgment doctrine while critics of the substituted judgment doctrine continue to wage war with its supporters over its appropriateness in medical contexts, courts have persistently applied the doctrine in several recent cases. after applying the sub­ stituted judgment doctrine, the court in strunk v. strunk permitted the harvest­ ing of an incompetent adult's kidney. 83 in strunk, the mother of an incompetent adult petitioned the court in order to permit the surgical removal of her son's kidney for the benefit and survival ofhis brother.84 although the fa­ ther consented to the procedure as well, the guardian ad litem, who was ap­ pointed to represent the incompetent adult's interests, opposed the transplant. the court, after holding that the transplant was permissible, declared that "[t]he right to act for the incompetent in all cases has become recognized in this coun­ try as the doctrine of substituted judgment and is broad enough not only to cover property but also to cover all matters touching on the well-being of the ward. "85 although the court purported to apply the substituted judgment doc­ trine, it neglected to discuss what the incompetent adult would do if he were competent. instead, the court focused on the psychological well-being of the incompetent donor by taking into account his dependency upon his brother and the emotional devastation he would face in the event of his brother's death. 86 three years after strunk, a connecticut court in hart v. brown determined that parents of minor twin daughters had the authority to consent to the trans­ plantation of a kidney from one child to the other.87 like the court in strunk, the hart court claimed to apply the substituted judgment doctrine. 88 the court, however, failed to ascertain what the donating child would do if she were a competent adult. rather, the court concluded that .. after a close, independent and objective investigation of their motivation and reasoning," the parents could substitute their judgment for that of the child. 89 the court further noted, 80 id. 81 robertson, organ donations, supra note 75, at 64. 82 shartle, supra note 11, at 448. 83 strunk v. strunk, 445 s.w.2d 145, 149 (ky. 1969). 84 id. at 145-46. 85 /d. at 148. 86 id. at 149. 87 hart v. brown, 289 a2d 386,391 (conn. super. ct. 1972). 88 /d. 89 id. at 390. 2007] harvesting organs from minors and incompetent adults 331 [t]o prohibit the natural parents and the guardians ad litem of the minor children the right to give their consent under these circumstances, where there is supervision by this court and other persons in examining their judg­ ment, would be most unjust, inequitable and injudicious. therefore, natural parents of a minor should have the right to give their consent to an isograft kidney trans­ plantation procedure when their motivation and reason­ ing are favorably reviewed by a community representation, which includes a court of equity.90 a texas court also explicitly adopted the application of the substituted judgment doctrine in little v. little.91 in little, the mother of a mentally re­ tarded minor child sought the removal of the child's kidney for the purpose of transplanting it into the child's ill brother.92 the guardian ad litem assigned to the case opposed the operation.93 after fmding that the siblings had a close relationship, a concern for the well-being of one another, and the incompetent underage child was aware of her brother's condition and was aware that she was in a position to alleviate his pain, the court permitted the harvesting.94 fur­ thermore, the court stated, "assuming that [the incompetent child] is incapable of understanding the nature of death, there is ample evidence to the effect that she understands the concept of absence and that she is unhappy on the occa­ sions when [her brother] must leave home for hours ... for dialysis."95 addi­ tionally, the court established that the incompetent child was capable of experiencing an increase in personal welfare as a result of donating her kid­ ney. 96 the court concluded that the "substantial psychological benefits from such participation" outweighed the minimal risks and discomfort associated with the donation. 97 though its use in the medical field continues to be debated, it is clear from these recent decisions that courts will not be influenced by biased com­ mentary. from the earliest days of dividing land of an incompetent adult to permitting organ and tissue harvests from minors and incompetent adults, the substituted judgment doctrine has evolved into an innovative standard, which courts rely upon in a wide variety of contexts. 90 /d. at 391. 91 little v. little, 576 s.w.2d 493, 498 (tex. app. 1979). 92 /d. at 494. 93 /d. 94 /d. at 500. 95 id. at 498-99. 96 /d. at 499. 97 /d. at 500. 332 indiana health law review [vol. 4:319 3. endorsements, evaluations, and criticisms of the substituted judgment doctrine many supporters of the substituted judgment doctrine believe that its ap­ plication is superior to the best interest standard because the doctrine respects individual autonomy.98 supporters believe that the substituted judgment doc­ trine is an appropriate test in medical contexts because it provides incompetent individuals with ''the same degree of freedom as competent persons in deciding whether they will undergo or continue invasive medical treatment "99 thus, the doctrine is said to treat minors and incompetent persons as autonomous human beings who, like competent individuals, are entitled to consideration, dignity, and freedom of choice. 100 [t]he substituted judgment doctrine is explicitly non­ utilitarian, and makes no claim that the rights of incom­ petents may be overridden to advance the interests of others, where the rights of competents may not be simi­ larly overridden. rather than detract from respect for the persons of incompetents, the substituted judgment doctrine, properly understood, actually fosters respect. for it seeks to treat incompetents as competents are treated as creatures of choice, with the autonomy and dignity of choice, and whose choices as best as we can ascertain them are to be respected. it thus stands as a further elaboration of the personhood ofincompetents.101 because the fact finder determines what the minor or incompetent person would prefer were the minor or incompetent person capable of making the deci­ sion himor herself, 102 many commentators believe that the substituted judg­ ment doctrine takes into account a minor's or an incompetent person's autonomy and recognizes his moral worth.103 this approach gives the incompe­ tent person the benefit of the doubt by assuming his or her good nature and en­ dowing him or her with humanity's finest qualities!04 likewise, philosopher john rawls believes that in order to respect the integrity of a person, we must treat others "as we have reason to believe he would choose for himself if he 98 liacos, supra note 59, at 220..21; see also robertson, organ donations, supra note 75, at 76 (stating that a person's choice regardless of competence should be respected). 99 liacos, supra note 59. 100 !d. 101 robertson, organ donations, supra note 75, at 76. 102 edward d. robertson, jr., is "substituted judgment" a valid legal concept?, 5 issues l. & med. 197,200 (1989) [hereinafter ''robertson, jr., substituted judgmenr]. 103 id. at 206. 104 in re pescinski, 226 n.w.2d 180, 184 (wis. 1975) (day, j., dissenting). 2007] harvesting organs from minors and incompetent adults 333 were capable of reason and deciding rationally."105 this is not to suggest, how­ ever, that we are to impose preferences he or she never had or that previous desires are to be ignored. rather, "[p ]atemalistic decisions are to be guided by the individual's own settled preferences and interests insofar as they are not irrational, or failing a knowledge of these, by the theory of primary goods."106 in addition to respecting personal autonomy, the substituted judgment doctrine is widely supported because the doctrine encourages consistency. specifically, since incompetent adults are treated as persons with rights and awarded respect in other contexts, 107 consistency demands similar treatment for incompetent persons in this context. 108 "by failing to treat them as we treat competent persons, in similar situations, ascertaining and respecting their law­ ful choices, we might undercut respect for the incompetent persons in other situations, and eventually diminish respect for all persons."109 despite the persuasive line of reasoning supporting the substituted judg­ ment doctrine, the arguments against the doctrine cannot be ignored. the most compelling, and perhaps most disputed criticism of the substituted judgment doctrine, is that its use is not appropriate for individuals who were never before competent. the substituted judgment doctrine does not draw a distinction be­ tween persons whom have never before been competent and persons whom, though incompetent now, have been competent at some point in his or her life. 110 the doctrine applies in both classi:fications.111 since courts applying the substituted judgment doctrine seek to determine the decision a person would make if competent, many commentators find it "absurd" to apply this standard because it treats an incompetent individual as though he were competent when he possibly never had been. 112 it is impossible to discover a minor's or never­ before-competent adult's preferences by looking at their "philosophical, reli­ gious and moral views, life goals, values about the purpose oflife and the way it should be lived, and attitudes toward sickness, medical procedures, suffering and death. "113 courts are forced instead to rely on "evidence [that] is unreliable or unavailable," when the doctrine is applied to never-before-competent indi­ viduals.u4 when the court has before it a petition with evidence representing a formerly competent person's treatment decisions, however, the court can truly 105 john rawls, a theory of justice 209 (belknap press 1971 ). 106 jd. at 249. 107 for example, incompetent persons have rights equal to competent persons in the crim­ inal context. see people ex rel. myers v. briggs, 46 n.e.2d 281, 288 (ill. 1970) (stating that an incompetent person has a constitutional right to trial). 108 robertson, organ donations, supra note 75, at 64. 109 jd. 110 robertson, jr., substituted judgment, supra note 103, at 208. ill jd. 112 robertson, organ donations, supra note 75, at 65. 113 in re nancy ellen jobes, 529 a.2d 434,445 (n.j. 1987). 114 griffith, supra note 38, at 303. 334 indiana health law review [vol. 4:319 communicate that person's decisions through the application of the substituted judgment doctrine.115 on the other hand, it is impossible for judges to under­ stand an incompetent person's wishes without ever having the slightest indica­ tion of those wishes. 116 thus, the application of the substituted judgment doctrine in circumstances involving minors and never-before-competent indi­ viduals is said to result in a "legal fiction."117 proponents of the substituted judgment doctrine respond that evidence of net benefits should serve as a surrogate for determining what the minor or in­ competent adult would have chosen. 118 they justify this proposition by pre-­ suming that a child or incompetent adult would only choose what benefits him­ or herself.119 these benefits do not need to be tangible or physical benefits but can be psychologically or physiologically beneficial as well.120 proponents con­ tend that if a court is convinced that no such benefit exists, only then may it decide that the minor or incompetent adult would not consent to the procedure if he or she were competent.121 nevertheless, critics of the substituted judgment doctrine maintain that if the doctrine is applied to a never-before-competent incompetent person, it is the judge who determines the incompetent individual's supposed wishes and then renders a decision.122 as a result of making a decision based on assumed wish­ es, the court and its litigants are attempting to be "blameless, choiceless assis­ tants" while placing "all responsibility for the decision •.. with the incompetent •••• " 123 critics argue that this practice does not reflect the values of the never­ before-competent adult at all but, in reality, represents the values of the true decision-maker: the judge.124 yet another criticism confronting the substituted judgment doctrine is that it deprives individuals of free choice and moral dignity.125 some commentators maintain that if personal preferences of an individual are not known, the substi115 robertson, jr., substituted judgment, supra note 103, at 208. it is argued that the substituted judgment doctrine is "best left to situations where a previously competent person expressed definite preferences regarding medical treatment, including organ donation, and due to an accident or some other intervening circumstance, is later unable to effectuate her wishes on her own." michael t. morley, proxy consent to organ donation by incompetents, 111 yale l.j. 1215, 1235-36 (2002). 116 robertson, jr., substituted judgment, supra note 103, at 208. 117 griffith, supra note 38, at 303. a legal fiction is "an assumption that something is true even though it may be untrue. made esp[ ecially] in judicial reasoning to alter how a legal rule operates." black's law dictionary 409 (2d. ed. 2001 ). 118 robertson, organ donations, supra note 75, at 56-57. 119 ld. at 57. 120 dufault, supra note 8, at 224. 121 ld. 122 robertson, organ donations, supra note 75, at 207. 123 /d. at 207 n.48 (quoting walter m. weber, substituted judgment doctrine: a critical analysis, 1 issues l. & med. 131, 137 (1985)). 124 /d. 125 robertson, organ donations, supra note 75, at 61. 2007] harvesting organs from minors and incompetent adults 335 tuted judgment doctrine permits a court to impute the preferences of a reason­ able, competent person onto the incompetent individual. 126 proponents of the doctrine contend that assigning preferences to the individual is justified because "such an attempt would continue to regard him, even during his incapacity, as an individual with free choice and moral dignity, and not as someone whose preferences no longer mattered. " 127 this suggestion, however, completely un­ dermines the very nature of the substituted judgment doctrine. if the substi­ tuted judgment doctrine stands for anything, it is the idea that courts must ascertain what the particular incompetent individual would do and not what another reasonable competent person would do in the same situation. in super­ intendent of belchertown state school v. saikewicz, the court warned, "indi­ vidual choice is determined not by the vote of the majority but by the complexities of the singular situation viewed from the unique perspective of the person called on to make the decision."128 when a court applies this objective reasonable competent person standard and assigns preferences to an incompe-. tent individual, the court no longer regards the incompetent individual as an individual with free choice. to clarity, this approach requires courts to impute upon an incompetent individual what society deems is reasonable, which, by definition, deprives the individual of any "free choice and moral dignity. "129 furthermore, many opponents consider it impossible to recognize auton­ omy within the substituted judgment doctrine, even though proponents of the doctrine strongly believe in the doctrine's capabilities. autonomy means self-law; it means the ability to make decisions without reference to the values or wishes of others. . . . incompetent persons are not autonomous; they have no ability to decide. substituted judgment thus requires the acceptance of an oxymoronthat one's autonomy can be exercised by another .... "[t]hat deci­ sions concerning a particular person's fate are better made for him than by him, because others wiser than he are tnore keenly aware of his best interests than he can be conflicts with the notion of a right to self­ determination. "130 lastly, critics of the substituted judgment doctrine have found that its use de­ nies individuals the very autonomy from which it purports to be derived. 131 126 ld. 127 ld. at 63. 128 superintendent ofbelchertown state sch. v. saikewicz. 370 n.e.2d 417,428 (mass. 1977). 129 robertson, organ donations, supra note 75, at 63. 130 robertson, jr., substituted judgment, supra note 103, at 206. 131 id. at 206. 336 indiana health law review [vol. 4:319 a final argument made by opponents of the substituted judgment doctrine is that parents or guardians, to whom courts look for prior beliefs and values of the incompetent individual, may act with bias judgments and their own interests in mind. "if the decision-maker is affected by his own value judgments, in­ volvement, emotions, and interest, he will not be detached and neutral, and hence will be less able to 'don the mental mantle of the incompetent,' as the doctrine of substituted judgment calls on him to do."132 although the presump­ tion exists that the "natural bonds of affection" will necessarily cause parents to act in the best interests of their children, the ability of parents to act in the best interests of their minor child as a prospective organ or tissue donor has been criticized when those parents are faced with the potential death of another child.133 if parents are given the authority to substitute their judgment for the child, they will undoubtedly be strongly influenced by what they hope their child would do if he or she were competent. thus, parental aspira­ tions for their child, usually including generosity and love toward the ill sibling, seem likely to bias the substi­ tuted judgment that they or the court reach for their child.134 economic hardships as well as sibling-to-sibling donations, where families are under extreme emotional strain, may adversely affect a surrogate's decision­ making ability. b. the best interest standard unlike the substituted judgment doctrine, whose roots date back to early english law, the best interest standard is derived from the state's parens patriae power.135 as opposed to the subjectively applied substituted judgment doc­ trine, the best interest standard is an objective test, which focuses on protecting the minor or incompetent adult.136 under this standard, the court evaluates the benefits and risks of the transplantation to the potential donor in order to deter132 liacos, supra note 59, at 221. 133 parham v. j.r., 442 u.s. 584, 602 (1979); see robbennolt et al., supra note 55, at 226. 134 robbennolt et al., supra note 55, at 226. 135 /nreconroy,486a2d 1209,1231 (n.j.l985)("[1]hestate'sparenspatriaepower supports the authority of its courts to allow decisions to be made for an incompetent that serve the incompetent's best interests .... "); see finlayv. finlay, 148 n.e. 624,626 (n.y. 1925); robertson, jr., substituted judgment, supra note 103, at 211. 136 seelnredoe,481 n.y.s.2d932, 933 (app.div.1984);/nrepescinski,226n.w.2d 180, 182 (wis. 1975); shartle, supra note 11, at448-49. 2007] harvesting organs from minors and incompetent adults 337 mine if the transplant is appropriate. 137 the court will permit a transplant if it determines that the procedure is in the best interests of the prospective donor.138 the primary consideration that the best interest standard seeks to discover is: "[w]hat will promote the welfare of the child [or incompetent adult]?"139 be­ cause in most cases it is not in the physical best interest of a healthy minor or incompetent adult to donate an organ or tissue, 140 courts consider whether the prospective donor will benefit psychologically from the procedure. 141 1. the best interest standard and the use of psychological benefits to determine whether the harvesting of organs or tissue is in the minor or incompetent donor's best interest, courts focus on the psychological impact of donating versus not donating.142 if the court finds that a psychological benefit does in fact exist, it will then determine whether the psychological benefit out­ weighs the risks associated with the operation.143 some psychological factors courts have considered include the following: the quality of the relationship between the prospective donor and the recipient, 144 the possibility of alternative medical treatment, 145 the prospective donor's level of understanding of the pur­ pose he or she plays in the situation, 146 and the recipient's medical condition both with and without the transplant. 147 the emerging rationale for allowing organ and tissue harvests from minors and incompetent individuals is that the donor will psychologically benefit from the procedure.148 many commentators, however, debate whether psychological factors should be taken into account at 137 see curran v. bosze, 566 n.e.2d 1319, 1343 (dl. 1990);doe, 481 n.y.s.2dat 933; shartle, supra note 11, at 448-49. 138 see cu"an, 566 n.e.2d at 1331; doe, 481 n.y.s.2d at 933; charles h. baronet al., live organ and tissue transplants from minor donors in massachusetts, 55 b.u. l. rev. 159, 170 (1975). 139 robbennolt et al., supra note 55, at 222. 140 see cu"an, 566 n.e.2d at 1343. 141 baronet al., supra note 139. 142 see doe, 481 n.y.s.2d at 932; robbennolt et al., supra note 55, at 222. 143 see doe, 481 n.y.s.2d at 933; robbennolt et al., supra note 55, at 222. 144 see cu"an, 566 n.e.2d at 1343. 145 see doe, 481 n.y.s.2d at 932. 146 see little v. little, 576 s.w.2d 493, 500 (tex. app. 1979). 147 see strunk v. strunk, 445 s.w.2d 145 (ky. 1969); doe, 481 n.y.s.2d at 933; rob­ bennolt et al., supra note 55, at 223. it is argued that in its truest form, the best interest standard should focus solely on the interests of the donor and should not take into account the interests of the prospective recipient. griner, supra note 67, at 607. as case law will suggest, however, courts often consider the interests of the recipient. see doe, 481 n.y.s.2d at 932; in re rich­ ardson, 284 so. 2d 185 (la. ct. app. 1973); griner, supra note 67, at 600. for example, courts have considered factors such as the potential recipient's imminent need for the organ or tissue as well as the lack of alternative treatment for the recipient. see doe, 481 n. y.s2d at 932; rich­ ardson, 284 so. 2d at 185; griner, supra note 67, at 600. 148 cheyette, supra note 32, at 471. 338 indiana healtii law review [vol. 4:319 all. proponents ofharvesting procedures and the use of psychological benefits argue that minors and incompetent adults will experience significant psycho­ logical benefits by preventing the loss of a loved one. 149 the donor is thus pro­ tected from any trauma he or she may have suffered from the loss of a relative.15° furthermore, it is argued that ''by conferring on him or her benefits associated with altruistic acts," the donor will have an increased self-esteem and self worth. 151 "studies of persons who have donated kidneys reveal resulting positive benefits such as heightened self-esteem, enhanced status in the family, renewed meaning in life, and other positive feelings including transcendental or peak experiences flowing from their gift of life to another. "152 it is psychologi­ cal benefits such as these that supporters believe the court should consider when deciding whether to permit the transplant opponents argue that, by considering psychological benefits, the court au­ tomatically assumes that the recipient will survive the transplant 153 one of the main reasons courts permit the use of psychological benefits is to prevent any traumatic effects the vulnerable donor may endure from losing a close relative if the transplant is not permitted.154 this justification, however, is entirely un­ dermined if the recipient does not survive the transplant. moreover, an additional flaw exists when courts encompass psychological benefits into the best interest standard. when courts evaluate a harvesting peti­ tion and take into account psychological benefits to the donor, the court errone­ ously presumes that all individual~ will be able to appreciate the psychological benefit. low functioning mentally disabled individuals, however, may never be able to appreciate the nature of their altruistic acts. "the incompetent may not be able now, nor in the near future, to comprehend the meaning of charity or the social norms surrounding gift-giving, and thus may lack the capacity to taste the immediate psychological fruits of altruism."155 similarly, children may be unable to comprehend the nature of their altruistic behavior due to their young age. 156 when a situation such as this arises, psychological benefits may never be present and thus, may not need to be considered at all. 2. application of the best interest standard and the use of psychological benefits regardless of the criticisms presented, courts continue to consider the 149 /d. iso /d. lsi /d. 152 little v. little, 576 s.w.2d 493, 499 (tex. app. 1979). 1s3 cbeyette, supra note 32, at 474. 154 /d. at 471. iss robertson, organ donations, supra note 75, at 70. 156 griner, supra note 67, at 600. 2007) harvesting organs from minors and incompetent adults 339 psychological benefits an individual may experience when determining whether it will permit the harvest. for example, the louisiana court of appeals con­ cluded that the possibility of the incompetent minor experiencing any psycho­ logical benefits was "highly speculative" and "highly unlikely."157 in richardson, the mother of an incompetent minor consented to a harvesting pro­ dedure. although the mother consented to the procedure, the father of the in­ competent minor sued the mother in order to bring the issue of consent before the court. 158 the court examined the likelihood that the minor donor would experience any psychological benefits, such as the possibility that the recipient sister would be the incompetent minor's caretaker after the death of their par­ ents. nevertheless, the court declined to recognize any such psychological ben­ efits.159 the court based its decision on principles found in louisiana property law, 160 which promotes the best interest ofthe minor in property contexts. the court found a parallel between intruding into a minor's real property right and invading a minor's body. 161 the court insisted that because louisiana property law maintains the same protection from "intrusion into a comparatively mere property right, it is inconceivable to us that it affords less protection to a mi­ nor's right to be free in his person from bodily intrusion to the extent ofloss of an organ unless such loss be in the best interest of the minor."162 the court then concluded that neither the incompetent minor's parents nor the court had the power to authorize the harvest for the purpose of donating his organ to his sister. 163 thus, in richardson the court denied the harvest petition ordering a kidney transplant from an incompetent minor to his sister.164 in pescinski, the wisconsin supreme court reached a conclusion similar to that in richardson only two years later. 165 in pescinski, the guardian of an incompetent adult petitioned the court to order a harvest of the incompetent adult's kidney and transfer it to his sister. the court affirmed the lower court's holding that the judiciary did not have the power to authorize the kidney har­ vest absent any "real consent on his part, and in a situation where no benefit to him has been established .... " 166 the court demonstrated its approval of the best interest standard and also explicitly rejected the substituted judgment doc­ trine.167 after discussing the historical background of the substituted judgment 157 in re richardson, 284 so. 2d 185, 187 (la. ct. app. 1973) 158 id. at 186. 159 ld. 160 ld. 161 !d. 162 !d. 163 jd.atl87. 164 !d. 165 in re pescinski, 226 n.w.2d 180, 180 (wis. 1975). 166 !d. at 182. 167 !d. 340 indiana health law review [vol. 4:319 doctrine and its use for allotting gifts of property taken from an incompetent individual, the court stated, "if applied literally, [the substituted judgment doc­ trine] would allow a trial court, or this court, to change the designation on a life insurance policy or make an election for an incompetent widow, without the requirement of a statute authorizing these acts .... " 168 the court concluded, "an incompetent particularly should have his own interests protected. cer­ tainly, no advantage should be taken ofhim. "169 the best interest standard was the approach to provide such protection. in doe, unlike pescinski, the new york judiciary declared that it did pos­ sess the power to authorize such a procedure, as derived from its parens patriae power.170 in doe, the court was asked to authorize a bone marrow transplant from an incompetent adult to his brother.171 this court considered the psycho­ logical benefits the donor would potentially receive from the harvest.172 the court determined that the risk to the donor was minimal and that the transplant from the incompetent individual was the only reasonable medical alternative. thus, the court held that the benefits to the incompetent adult outweighed the risks associated with the procedure.173 the court then concluded that the exis­ tence of psychological benefits, including the fact that the recipient was the sole family member making life decisions for the incompetent adult, determined that the procedure was in the incompetent adult's best interests.174 in 1990, the illinois supreme court was faced with the landmark case of curran v. bosze.115 although equipped with rich substantive law from cases like richardson, pescinski, and doe, the curran court was faced with a slight variation on the factual circumstances making curran more complex than the others.176 in curran, a father sought to compel a compatibility test for a bone marrow transplant from his dying son's half-siblings who were three-year-old twins (of whom he was also the father}. the mother of the three-year-old twins refused to consent to the test. further, pursuant to a court order, the mother had sole custody and care of the twins, and the evidence did not indicate that the twins had a familial relationship with their dying half-brother.177 the facts pre­ sented in curran are, therefore, different from those in previous cases where 168 /d. 169 /d. 170 in re doe, 481 n.y.s.2d 932,932 (app. div. 1984). 171 /d. 172 see id. at 933. 173 /d. 174 /d. this court recognizes one of the criticisms of the best interest standard. the court acknowledges that there is a presumption that the recipient will unquestionably survive when psychological benefits are taken into consideration. the court stated, "we agree that the bene­ fits to the incompetent if his brother lives outweigh the physiological and psychological risk .. .. " /d. the court, however, merely speaks of it and continues to conclude as it does. 175 curran v. bosze, 566 n.e.2d 1319, 1319 (ill. 1990). 176 /d. 177 /d. at 1344. 2007] harvesting organs from minors and incompetent adults 341 the donor and recipient are full siblings and had a social relationship. in curran, the court explicitly rejected the use of the substituted judgment doctrine.178 the court found that the twins had not "yet had the opportunity to develop 'actual, specific express intent,' or any other form of intent, with regard to serving as a bone marrow donor."179 in addition, the court stated, "a guard­ ian attempting to prove what a 3 y:z-year-old child would or would not do in a given set of circumstances at a given time in the distant future would have to rely on speculation and conjecture.''180 moreover, the court held that "a parent or guardian may give consent on behalf of a minor daughter or son for the child to donate bone marrow to a sibling, only when to do so would be in the minor's best interest."181 the court discussed the following three necessary factors in determining whether the donation would be in the best interests of the child.182 first, the parent who consents on behalf of the child must be informed of the risks and benefits inherent in the bone marrow harvesting procedure to the child. second, there must be emotional support available to the child from the person or persons who take care of the child .... third, there must be an existing, close rela­ tionship between the donor and recipient.183 the court then applied these factors to the facts of the case. first, the court acknowledged that both the mother and the father were informed ofthe risks associated with performing a bone marrow harvesting procedure on the twins. 184 second, the court recognized that there would be a lack of emotional support available to the twins from their mother because she did not consent to the procedure.185 third, the court stated that the half-siblings lacked the emo­ tional bonds necessary to permit the harvest.186 based on that analysis, the court held that participation in the procedure would not be in the minor twins' best interest.187 178 !d. at 1326. 179 id. 180 id. 181 !d. at 1331. 182 id. at 1343. 183 ld. 184 id. at 1344. 185 id. 186 see id. at 1343. the court stated. "only where there is an existing relationship be­ tween a healthy child and his or her ill sister or brother may a psychological benefit to the child from donating bone marrow to a sibling realistically be found to exist." i d. at 1344. 187 id. at 1345. 342 indiana health law review [vol. 4:319 3. endorsements, evaluations, and criticism of the best interest standard like the substituted judgment doctrine, the best interest standard faces both praise and criticism. one of the main reasons proponents of the best inter­ est standard believe this test is superior to the substituted judgment doctrine is because of its focus on protecting the welfare of the prospective donor instead of substituting preferences for those minor and incompetent adults, whose val­ ues and beliefs are undefined.188 on the other hand, opponents of the standard believe that this test is elusive and contains no model for determining what con­ stitutes a benefit.189 the best interest standard has been criticized for its lack of standards or criteria and the amount of such benefit that must be shown in order for it to be in the individual's best interest.190 one commentator argues that the best inter­ est standard "has been so vaguely and loosely applied as to permit arbitrary ma­ nipulation for utilitarian ends.''191 he believes that by taking into account psychological benefits, courts encourage false testimony about the relationship between the donor and recipient siblings.192 unclear and imprecise criteria is just one reason why many critics believe that the best interest standard is infe­ rior to the substituted judgment doctrine. yet another reason opponents disagree with the best interest standard is due to the belief that the standard's objective element demeans humanity. spe­ cifically, it is argued that by objectively deciding what is in an individual's best interest, the individual's subjective wishes and desires are ignored.193 by fail­ ing to acknowledge the individual's preferences, the individual's humanity is demeaned.194 in saikewicz, the court stated, ''to presume that the incompetent person must always be subjected to what many rational and intelligent persons may decline is to downgrade the status of the incompetent person by placing a 188 robbennoltetal.,supranote55, at224-2s. see supra notes 106-13andaccompany­ ingtext. !d. 189 robertson, organ donations, supra note 75, at 56. 190 id. the author argues: courts have readily determined that such intangible psychological factors as the traumatic impact of the recipient's death on the donor, or the denial to him of the psychic pleasures he receives from interaction with the recipi­ ent are benefits that justify transplants. even in cases where testimony on the psychic effects appears substantial, as in strunk, skepticism about rely­ ing on such evidence of benefits seems warranted. at times this testimony appears contrived, as when the donor is too young to have developed the deep ties with the sibling that the testimony suggests. 191 !d. 192 !d. 193 see liacos, supra note 59, at 221. 194 !d. 2007] harvesting organs from minors and incompetent adults 343 lesser value on his intrinsic human worth and vitality."195 it has been suggested that when the best interest standard is forced upon individuals by the state, whether with benign motives or not, it "moves society one step further down the road toward authoritarianism.''196 lastly, the best interest standard is criticized for its use in situations when parents are the decision-makers for both the donor child and the recipient child. 197 although they may deny its existence, parents "cannot divorce the extreme need of one child from the interests of the healthy child. "198 conse­ quently, when parents act as decision-makers for both the donor child and the recipient child, a conflict of interest results.199 such a conflict of interest ensues because a human element exists, and parents are "neither omnipotent nor im­ mune to acting out of self-interest. "200 moreover, the love and hopelessness felt for their other child "might blind them to the real magnitude ofharms their do­ nor child would suffer'' from the transplantation.201 some commentators sug­ gest that the best interest standard is more valuable "in situations where competing values are not involved, and families simply do not fall into that cat­ egory."202 it is often difficult, if not impossible, to separate individual interests from family interests. 203 furthermore, when children or incompetent adults are only able to comprehend the familial relationship in its most elementary nature, the likelihood of coercion or influence exerted by a parent or guardian is in­ creased. the parent's or guardian's view is imposed on the child. "the inter­ ests of more than one person are at stake. to attempt to cram a formal relation into an intimate context does violence to the morally significant aspects of the family relationship. "204 although the best interest standard focuses on protecting the welfare of the prospective donor instead of substituting the preferences for those whose values and beliefs are undefined, many commentators find its use inappropriate and inferior to the substituted judgment doctrine. due to its paternalistic, un­ structured approach, its high probability for coercion by a parent or guardian, 195 superintendent of belchertown state sch. v. sailrewicz, 370 n.e.2d 417, 428 (mass. 1977); see liacos, supra note 59, at 221. 196 liacos, supra note 59, at 221. it has further been argued that when the best interest standard is imposed upon individuals by the state, it "strips [incompetent potential donors] of their humanity and reduces them to mere vortices for resources and benefits." morley, supra note 116, at 1241. 197 griner, supra note 67, at 602-03. 198 !d. 199 susan zinner, cognitive development and pediatric consent to organ donation, 13 cambridge q. health care ethics 125, 130 (2004). 200 dufault, supra note 8, at 235. 201 zinner, supra note 200. 202 !d. 203 !d. 204 robert a. crouch & carl elliott, moral agency and the family: the case of living related organ transplantation, 8 cambridge q. health care ethics 275, 280 (1999). 344 indiana healtii law review [vol. 4:319 and its failure to acknowledge the potential donor's actual preferences, the best interest standard faces persistent opposition throughout the medical world. vi. policy concerns related to harvesting organs and tissue from minors and incompetent adults it is no surprise that in certain contexts incompetent adults do not enjoy the same legal rights as competent adults.205 the law does not often extend to incompetent adults the same personal and property rights as other citizens. 206 furthermore, while minors retain some liberty interests with respect to their bodies, 207 these rights are limited by laws enacted by a paternalistic legislature. although these limitations are in place to provide protection to minors and in­ competent adults, it is believed that many laws protecting the interests of mi­ nors and incompetent adults go well beyond what is necessary.208 much controversy transpires because courts and legislatures are quick to defend com­ petent donors from compelled harvests while merely deferring to third parties when minors or incompetent persons are involved. 209 a. no duty to rescue tort law principles to support the assertion that minors and incompetent adults should not be used in organ or tissue harvesting procedures, commentators cite the legal pre­ mise that there is no duty to rescue.z10 opponents of the harvesting procedure argue that even when the benefits to the recipient are great or the recipient is in danger of losing his or her life, the law does not impose upon society a duty to donate one's organs or tissue. 211 the law does not impose this duty upon soci­ ety because of the general notion that there is no duty to rescue or render aid, absent some special relationship giving rise to such duty. 212 in mcfall v. shimp, the court applied the well-established principle to or­ gan donations "which provides that one human being is under no legal compul205 cruzan v. dir., mo. dep't of health, 497 u.s. 261, 289-92 (1990) (o'connor, j., concurring) (recognizing a duty to protect the liberty interests of incompetent patients through the enactment of special procedures). 206 morley, supra note 116, at 1216, 1225. 207 see roe v. wade, 410 u.s. 113 (1973)(establishingtheright of privacy in the area of abortion); planned parenthood of cent. mo. v. danforth, 428 u.s. 52 (1976) (recognizing the right of a minor to consent to an abortion). 208 cheyette, supra note 32, at 467-68; see griner, supra note 67, at 600; harmon, supra note 65, at 57. 209 harmon, supra note 65, at 57. 210 zinner, supra note 200, at 129. 211 see mcfall v. shimp, iopa. d. & c.3d 90,92 (1978); zinner,supranote200, at 129. 212 people v. oliver, 210 cal. app. 3d 138, 147 (ct. app. 1989); see handiboev. mccarthy, 151 s.e.2d 905,907 (ga. ct. app. 1966); restatement(second)oftorts § 314(1965). 2007] harvesting organs from minors and incompetent adults 345 sion to give aid or to take action to save another human being or to rescue."213 in mcfall, the tissue recipient needed a bone marrow transplant in order to live. 214 his relative and only suitable donor, however, refused to consent to the transplant.215 the recipient attempted to use the courts as a means of compel­ ling his relative to donate.216 nevertheless, the court denied the compelled transplant and concluded that society should not infringe upon an individual's "absolute right to his 'bodily security' ."217 while the court noted that the de­ fendant's refusal was "morally indefensible," it was quick to recognize that the decision ultimately rested with the defendant.218 for our law to compel defendant to submit to an intru­ sion of his body would change every concept and princi­ ple upon which our society is founded. to do so would defeat the sanctity of the individual, and would impose a rule which would know no limits, and one could not imagine where the line would be drawn.219 in expressing its aversion to compelling an individual to undergo an invasion of his body for the benefit of another, the court further declared, for a society which respects the rights of one individual, to sink its teeth into the jugular vein or neck of one ofits members and suck from it sustenance for another mem­ ber, is revolting to our hard-wrought concepts of juris­ prudence. forceable extraction of living body tissue causes revulsion to the judicial mind. such would raise the spectre of the swastika and the inquisition, reminis­ cent of the horrors this portends. 220 while it is clear that the law does not impose the duty to donate upon competent adults,221 many critics feel that the law does not defend minors or incompetent adults in the same fashion.222 regardless of the judicial standard applied, many commentators believe that using minors and incompetent adults as potential donors imposes good samaritan duties upon these individuals that 213 mcfall, 10 pa. d. & c.3d at 91. 214 id. at 90. 21s id. 216 id. 217 id. 218 /d. 219 /d. 220 /d. at 92 (first emphasis added). 221 see id. at 91. 222 dufault, supra note 8, at 216; see griner, supra note 67, at 600. 346 indiana health law review [vol. 4:319 are not imposed upon the rest of society. 223 furthermore, it is believed that re­ quiring the most vulnerable members of our society to donate "sacrifice[ es] [them] in the name of a utilitarian calculation which betrays the loyalty we owe to their sacred, individual personhood. "224 while one who fails to render aid may be labeled a "ruthless savage'.ns and "morally indefensible,'.n6 imposing a duty to rescue on minors and incompetent adults is believed ''to restrict individ­ ual discretion unacceptably. ,,227 b. the right to bodily integrity in 1891, the supreme court declared, ''no right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or inter­ ference of others, unless by clear and unquestionable authority oflaw. ,,ns both federal and state courts continue to recognize that "[t]he right to control medi­ cal decisions affecting one's body is deeply rooted in our country's history and tradition"229 and further hold that "a person has a strong interest in being free from nonconsensual invasion of his bodily integrity."230 with respect to com223 dufault, supra note 8, at 224. 224 zinner, supra note 200, at 129. in expressing his views on autonomy and personal liberties, mill stated: /d. [t]he only purpose for which power can be rightfully exercised over any member of a civilised community, against his will, is to prevent harm to others. his own good, either physical or moral, is not a sufficient warrant. he cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinions of others, to do so would be wise, or even right." john stuart mill, utiutarianism0nlmer.tyessay0nben1ham 135 (marywarnocked., world publishing co. 1971) (1859). mill believed that individuals have absolute freedom over their bodies, and the state cannot interfere with this freedom merely because it believes it is acting in the individual's best inter­ est. john stuart mill, on liberty in philosophy of law, 259,259 (joel feinberg & jules coleman eds., 6th ed. 2000). therefore, even if the indi­ vidual's decision is contrary to society's prevailing morals, values, and be­ liefs, mill believes that an individual's right to self-determination demands society's respect. 225 such v. amory mfg. co., 44 a. 809, 810 (n.h. 1897). 226 mcfall, 10 pa. d. & c.3d 90,91 (1978). 227 see viola c. brady, note, the duty to rescue in tort law: implications of research on altruism, 55 ind. l.j. 551, 551 (1979-1980). 228 union pac. ry. co. v. botsford, 141 u.s. 250,251 (1891). 229 grayv. romeo, 697 f. supp. 580,584 (d.ri. 1988). 230 superintendent ofbelchertown state sch. v. saikewicz, 370 n.e.2d 417, 424 (mass. 1977); see also cruzan v. dir., mo. dep't ofhealth, 497 u.s. 261,278 (1990)("[t]heprincip1e that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred from our prior decisions.''); gray, 691 f. supp. at 590 2007] harvesting organs from minors and incompetent adults 347 petent adults, the rights of bodily integrity and self-determination are welles­ tablished. these same rights, however, as applied to minors and incompetent adults are not as well defmed. absent a compelling justification, the constitutional right to privacy pro­ tects every individual's right to bodily integrity.231 the right to privacy "en­ compasses the right of a patient to preserve his or her right to privacy against unwanted infringements of bodily integrity in appropriate circumstances."232 notions of autonomy prevent doctors, family members, and the state from com­ pelling an individual to do what they believe is in the individual's best inter­ est. 233 so why should privacy protections and notions of autonomy be any less respected merely because the individual is a minor or incompetent adult? while the supreme court has never expressly afforded minors the right to bodily integrity, it has firmly implied that this right, in fact, does exist.234 fur­ thermore, federal and state courts have explicitly stated that minors enjoy this right. 235 in bellotti, the court stated, "a child, merely on account of his minor­ ity, is not beyond the protection of the constitution .... 'neither the four­ teenth amendment nor the bill ofrights is for adults alone. ,,n6 additionally, it is argued that constitutional rights "do not mature and materialize" only when children are considered legal adults or legally competent. 237 thus, at least in certain circumstances, it is believed that children, as well as incompetent adults, should enjoy the same privacy protections and notions of autonomy as compe­ tent adults.238 some rationalize permitting a bone marrow harvest from minors or in­ competent adults, as opposed to organ harvesting, on the theory that a bone marrow transplant is less invasive.239 this justification, however, is flawed be­ cause, "it is not the degree of bodily invasion itself that produces the problem. ("[t]he right of personal autonomy is the right to make medical decisions affecting oneself free from unwarranted governmental intrusion."); schloendorffv. soc 'y ofn. y. hosp., 105 n .e. 92, 93 (n.y. 1914) ("[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body."); hawkins, supra note 43, at 2094. 231 gray, 691 f. supp. at 584. 232 saikewicz, 370 n.e.2d at 424. 233 liacos, supra note 59, at 219. 234 ingraham v. wright, 430 u.s. 651, 674 (1977) ("[w]here school authorities, acting under color of state law, deliberately decide to punish a child for misconduct by restraining the child and inflicting appreciable physical pain, we hold that the fourteenth amendment liberty interests are implicated."). 235 see, e.g., doe v. taylorlndep. sch. dist., 15 f.3d443, 450-51 (5th cir. 1994); black v. indiana area sch. dist., 985 f .2d 707, 709 (3d cir. 1993); in re l., 632 a.2d 59, 62 (conn. super. ct. 1993); custody of a minor, 393 n.e.2d 836, 844 (mass. 1979). 235 bellotti v. baird, 443 u.s. 622, 633 (1979) (quoting in re gault, 387 u.s. 1, 13 (1967)). 237 griner, supra note 67, at 600. 238 !d. because children and incompetent adults fall within the state's protective power, it is argued that the state is required to recognize "their dignity and worth and afford[] them the same range of rights and choices that it recognizes in competent persons." see id. 239 !d. at 608. · 348 indiana health law review [vol. 4:319 the right to maintenance ofbodily integrity is a matter of a right to privacy that is not subject to degrees of invasion. "'240 even the least invasive procedure, at a minimum, violates the right of privacy. 241 "it is recognized that children [and incompetent adults] may have different rights under the constitution, but these differences are to protect. .. [them] and their particular vulnerabilities, not to make them more vulnerable.'.242 because harvesting tissue or organs from a competent adult would violate his or her right to privacy and right to bodily integrity (absent consent), at least one court believes that minors and incompe­ tents should similarly be protected. 243 c. using the fetus as an organ farm like the california couple who became overwhelmingly desperate to pro­ vide their terminally ill daughter with an organ, many parents and guardians have similarly conceived additional children as a means of providing a suitable donor.244 accordingly, critics believe that by allowing parents to consent for medical treatment on their child's behalf, parents are only further encouraged to conceive children for the sole purpose of using the fetus as an organ farm. fur­ thermore, many commentators criticize parents and guardians for conceiving children in these circumstances because some parents and guardians decide to abort the fetus or put the baby up for adoption after learning that the fetus is not a proper match. 245 this practice is perceived as "an immoral objectification of the donor child that leads parents to view it as instrumentally valuable for its organs, rather than as inherently valuable."246 although it does not consequen­ tially prevent the family from loving the child, it is believed that conceiving a child under these circumstances "does present problems with respect to ration­ alizing consent for a procedure that confers no physiologic value on the do­ nor."'247 240 id. 241 see id. 242 id. 243 superintendent of belchertown state sch. v. saikewicz, 3 70 n.e.2d 417, 428 (mass. 1977) ("(t]he 'best interest' of an incompetent person are not necessarily served by imposing on such persons results not mandated as to competent persons similarly situated. it does not ad­ vance the interest of the state or the ward to treat the ward as a person oflesser status or dignity than others."). 244 matthew b. hsu, banning human cloning: an acceptable limit on scientific inquiry or an unconstitutional restriction of symbolic speech?, 87 geo. l.j. 2399, 2425 n.200 (1999). in 1991, one survey showed that at least forty bone marrow transplants were a result of parents conceiving a child to serve as a donor. id. 245 cheyette, supra note 32, at 499. 246 morley, supra note 116, at 1246; see prince v. massachusetts, 321 u.s. 158, 166 (1944) ("[t]he custody, care, and nurture of the child reside first in the parents.''). 247 griner, supra note 67, at 605-06. the author suggests that a child who is conceived primarily for his or her organs may suffer from some psychological distress later in life. see id. 2007] harvesting organs from minors and incompetent adults 349 yet another criticism of conceiving a child primarily for his or her organs is that it presumes that family interests and family autonomy trumps an individ­ ual's self-interests.248 some commentators believe, however, that respect for persons should limit the right to family autonomy. 249 respect for persons is derived from the traditional kbntian maxim that all persons should always be treated as an ends and never as a means.250 the moral dilemma with conceiv­ ing a child to serve as an organ donor is that the conceived child is treated sole­ ly as a means rather than as an end, which is contrary to kantian theory. as one commentator states, "(t]he state can and ought to prohibit parents from using their child as a donor ... if it finds the donation incompatible with re­ specting the child's personhood . ..1st supporters justify the practice arguing that donating an organ or tissue to a family member results in the child serving both as a means and as an end. 252 the child serves as a means by advancing the family's interest through dona­ tion of an organ or tissue. 253 because the child is also a member of the family, any advancement of the family's interest advances the child's interest.254 in addition to serving as a means for improving the health of another, the child is simultaneously serving as an end by advancing the child's own interests by sav­ ing the life of a loved one. 255 arguably, the result is then in harmony with the kantian principle?56 the flaw in this theory, however, is that it assumes the child donor wants to donate his or her organ and promote the well-being of a family member. if the child, however, does not wish to donate then the child is being used solely as a means. the result, once again. is in conflict with kantian theory. still another obstacle stands in the path of those who oppose this practice: the united states constitution. prohibiting parents from conceiving children is unconstitutional regardless of the motive for conceiving.257 in eisenstadt v. baird, the supreme court stated, "if the right of privacy means anything, it is it is argued, however, that being born for a particular reason neither "inflicts a net harm on that child" noris contrary to a child's best interests. morley, supra note 116, at 1247. first, had the child not been conceived for the primary purpose of his or her organs, "the alternative for that child is never to have been born at all .... people conceive and give birth to children for a wide range of reasons, and often for mixed reasons or even no reason at all .... in light of some of the commonly accepted purposes for giving birth, doing so to save a life can hardly be a ground for moral reproach." /d. at 1247-48. 248 lainie f. ross, moral groundingfor the participation of children as organ donors, 21 j. l. med. & ennes 251, 253 (1993). 249 /d. at 252. 250 /d. at 253. 251 /d. 252 /d. 253 see ross, supra note 249. 254 see id. 2ss /d. 256 /d. 257 see eisenstadt v. baird, 405 u.s. 438 (1972). 350 indiana health law review [vol. 4:319 the right of the individual, married or single, to be free from unwarranted gov­ ernmental intrusion into matters so fundamentally affecting a person as the de­ cision whether to bear or beget a child .• .2ss although the constitution prohibits laws attempting to regulate this type of practice, and defenders of the right to conceive believe that it is improper to question a parent's motive for conceiv­ ing, it is important to distinguish between exercising one's right to conceive from exercising control over an infant by subjecting him or her to a surgical procedure. 259 it is the latter that opponents of conceiving children primarily for their organs seek to regulate. many ethical and moral dilemmas arise because minors and incompetent adults do not enjoy the same legal rights as competent adults in medical con­ texts. the duty to rescue, the right to bodily integrity, and the right to and mo­ tive behind conception are just a few examples of the ethical and moral issues that arise in these legal and medical contexts. regardless of the legal standard applied, however, much criticism transpires concerning the disparities between the medical rights afforded to competent adults and those provided to minors and incompetent adults. vll. proposed solution: an end to dual standards260 although the substituted judgment doctrine and the best interest standard are operative, they have proven to be impractical, illogical, and inappropriate thus begging for the creation of a new test. first, the standards are impractical because there are no criteria for determining whether the substituted judgment doctrine or the best interest standard will be used. while illinois clearly re­ jected the substituted judgment doctrine in curran and texas explicitly ac­ cepted the doctrine in little, these decisions offered very little in terms of determining which standard to apply. 261 not only are defined criteria necessary for future parents in similar situations, but also for consistency in and reliability on the judicial system. second, the substituted judgment doctrine and the best interest standard are illogical because the same standard applies whether or not the incompetent 258 id. at 453. 259 griner, supra note 67, at 606 n.l48 (citing alan derehowitz, don't rush to judge these parents, boston herald, feb. 26, 1990, at 23). 260 it should be noted that this solution assumes that no removal will be permitted if cer­ tain to result in the minor or incompetent adult's death after the organ or tissue is removed. this does not, however, include state laws that permit such removal for persons in a persistent vege­ tative state. furthermore, this solution does not allow any procedure to be perfonned on minors or incompetent individuals that the medical profession considers experimental. 261 while the lllinois supreme court discussed why the substituted judgment doctrine was not appropriate in curran specifically, the court's opinion is arguably limited to the facts of the case. see curran v. bosze, 566 n.e.2d 1319, 1325-26 (ill. 1990). it is not clear that the substituted judgment doctrine is to be explicitly rejected in all future cases. see id. 2007] harvesting organs from minors and incompetent adults 351 adult was competent at some point in his or her life. when a court can ascer­ tain an incompetent adult's wishes because he or she has been competent once before, it does not make sense to apply the same standard used for those whose wishes cannot be discerned. the court need not attempt to substitute its judg­ ment nor determine what is in the incompetent's best interests when a formerly competent incompetent adult has expressly stated his or her wishes. third, the standards are generally inappropriate in the medical context when parents act as decision-makers for both the donor child and the recipient child. a conflict of interest results because it is nearly impossible for parents to separate the interests of the healthy child from the hopelessness felt for their ailing child. therefore, the court should closely scrutinize any decision to har­ vest an organ or tissue that comes from a parent. the following factors provide the court with both a logical and practical way of reviewing petitions for har­ vesting organs and tissue from minors and incompetent adults. a. procedural requirements 1. courts should scrutinize any decision coming from a parent or guar­ dian while deference to parental autonomy is "deeply rooted in our nation's history and tradition,"262 it is important for the court to closely examine the mo­ tive behind and reason for a parent's or guardian's petition for a harvest. the state should investigate because, although parental control should not be unrea­ sonably hindered, 263 the state has a divergent interest in caring for members of our society in need of protection. 264 this power struggle between the state's interest in protecting vulnerable members of our society and a parent's or guar­ dian's right to make important medical decisions for their issue is ever-so pre­ sent when parents or guardians act as decision-makers for both the donor child and the child recipient. it is often the case that parents or guardians, who are acting as decision­ makers for both the donor child and the recipient child, are unable to separate their own values, interests, or emotions from the decision to harvest. 265 al­ though specifically applying the substituted judgment doctrine, the hart court similarly recognized the potential for such abuse. 266 the court reviewed the parents' motivation and reasoning for seeking permission to harvest their 262 see bellotti v. baird, 443 u.s. 622, 638 (1979). 263 prince v. massachusetts, 321 u.s. 158, 166 (1944)(citing pierce v. soc'y ofsisters, 268 u.s. 510, 534-35 (1925)). 264 hawkins, supra note 43, at 2084. 265 the concern about conflict is not an "accidental feature" of the best interest standard but is "the essence of the problem." james dwyer & elizabeth vig, rethinking transplantation between siblings, 25 hastings center report 5, 7 (1995). 266 see hart v. brown, 289 a.2d 386,391 (conn. super. ct. 1972). 352 indiana health law review [vol. 4:319 child's organ.267 in situations where the parents or guardians' interests are at odds with the donor's interests, the focus is no longer solely on the well-being of the minor or incompetent donor. rather, the parent or guardian is imposing a sacrifice on one child to benefit the other. it is the state's duty, at this point, to intervene in the private relationship in order to protect the well-being of the child or incompetent adult. due to the risk of abuse when the decision-maker is another family member or guardian, it is imperative that courts scrutinize any decision that comes from such a person. 268 even after the court finds that the pwpose of the petition is favorable, pa­ rental or guardian consent should not be the sole grounds for permitting the transplantation. rather, consent from such persons should merely serve as the procedural requirement, which would bring the issue before a court. after get­ ting into court by way of this procedural requirement, it is only then that the adversarial process should begin. 2. the adversarial process should be used in all cases the adversarial setting should be used in cases even when all parties con­ sent to the harvesting. 269 as such, the court should appoint a guardian ad litem for the prospective donor. this further protects the interests of the donor child from a conflict of interest concerning the parent or guardian mentioned above. while it is the prospective donor's family or guardian who may best know the donor and either what is in his or her best interest or what he or she would do if competent, a judge can and should gain this information from testimony offered by the prospective donor's family or guardian. it is through the adversarial process that the judge can discredit any potential biases a family member or guardian may have due to the nature of their relationship with the prospective donor.270 267 /d. at 390. in hart, the court ultimately concluded that the parents could substitute their judgment for that of the child after their judgment was closely examined by the court. !d. 268 see korins, supra note 34, at 503. 269 while utilizing the adversarial process in all cases may be costly and place additional burdens on an already overcrowded judicial system, the need to truly protect a child's or incom­ petent adult's interests substantially outweighs these costs and burdens. if petitions for organ or tissue harvests do become too great in number, however, the use of administrative law judges may provide an efficient and practical solution. not only would the petitions no longer be in­ conveniencing the courts, but also the administrative law judges would become experts in organ and tissue harvest petitions, thus making the petitioning process more efficient and cost­ effective for all parties involved. 270 normal trial techniques may be used during the adversarial process in order to seek the truth from any witness (i.e. cross-examination). 2007] harvesting organs from minors and incompetent adults 353 3. courts should review petitions only if no reasonable medical alterna­ tive exists harvesting procedures should never include minors and incompetent adults, and courts should refuse to review petitions for such procedures unless all other reasonable opportunities for transplantation have been exhausted. items the court should consider in determining whether a reasonable medical alternative exists include the following: 271 ( 1) whether a competent and com­ patible adult living donor exists;272 (2) whether an effective transplantation from a cadaver donor is likely; (3) whether the recipient has enough time to wait for a cadaver donor; ( 4) whether extracorporeal mechanisms such as kid­ ney dialysis are adequate for the recipient to survive;273 and ( 5) whether a medi­ cal cure or alternate corrective procedure is imminent.274 only when reasonable alternatives do not exist should the court consider using a minor or incompetent adult as a donor. even then, the court must consider all relevant remaining fac­ tors. b. the standard for formerly competent adults neither the substituted judgment doctrine nor the best interest standard is applied differently to incompetent individuals who have once been competent. the result of this has two detrimental flaws: (1) it fails to recognize a (formerly competent) incompetent individual's freedom of choice regarding previously decided medical decisions; and (2) it attempts to treat minors and never-before­ competent incompetent adults as though their wishes can be ascertained. as such, the court should no longer use the same standard for formerly competent individuals who are now incompetent compared with those individuals who were never before competent. 275 271 while the last three factors on the list do not focus solely on the donor's interest, the hannful effect on the donor is minimal because all of these items are procedural issues rather than substantive requirements. 272 a competent but unwilling donor does not qualify the individual as non-compatible. also, the level of compatibleness should depend upon medical standards and testimony from medical professionals. 273 in examining this factor, the court should not focus on whether the recipient desires to live on dialysis for the remainder of his or her life but whether such mechanisms are adequate for the recipient to survive. 274 given the significant advances in modem medicine and the fact that the medical field is developing new cures and technology for diseases at such a rapid pace, it is necessary to con­ sider whether such a development is forthcoming. "medical science has advanced to the point where some lives in the past [that] would have ended almost immediately can now be sustained or prolonged indefinitely." state v. pine, 524 a.2d 1104, 1107 (r.i. 1987). 275 because an individual is presumed to have been competent at some point in his or her life under this new standard, any party claiming that an individual was never before competent has the burden of proving that at no time was the individual a competent adult. furthermore, 354 indiana health law review [vol. 4:319 a different standard should apply to formerly competent incompetent in­ dividuals because then the individual's autonomy will truly be respected. when the court applies the substituted judgment doctrine or the best interest standard to an incompetent individual whom has previously expressed his or her wishes during a period of competency, the court is essentially treating that person as though his or her wishes do not matter.276 thus, the court has stripped the individual of his or her free choice.277 conversely, by applying a different standard for individuals whose medical wishes can be ascertained with sufficient evidence, the court is able to give effect to those wishes and genu­ inely respect the individual's free choice and personal autonomy. "complying with the previously expressed wishes of a now-incompetent [adult] pursuant to a subjective standard of decision-making would similarly be effectuating that person's right to self-determination. "278 after it is established that the incompetent individual was formerly com­ petent, the court should look at a variety of factors to determine whether the harvesting procedure should be permitted. the court should first focus on the donor's prior expressed preferences. while the donor's expressed preferences should be the primary consideration, values and beliefs of the incompetent in­ dividual maybe used as evidence to help support the donor's expressed inten­ tions. for example, the court may consider evidence of prior gift-giving in support of one's values. the incompetent individual's values and beliefs, how­ ever, may not be the sole evidentiary factor.279 yet another aspect of this new standard is the standard of proof required. the donor's explicit expressions of intent and his or her values and beliefs should be shown by clear and convincing evidence by the party petitioning the court for the transplantation.z80 if the evidence is not clear and convincing, the this proposed test is clearly not appropriate for minors because it is not possible for minors to fall into the category of once-competent individuals. 276 robertson, organ donations, supra note 75, at 207; see liacos. supra note 59, at 221. 277 /d. 278 in re conroy, 486 a.2d 1209, 1240 (n.j. 1985). 279 if the court were to focus solely on the individual's values and beliefs, the risk of abuse by all persons affected by the transplantation is too great. specifically, the same concerns raised when parents and guardians act as decision-makers are similarly raised when the potential donor has not expressively stated his intentions. again, family members and guardians may be unable to separate their own values, interests, or emotions. it should also be noted that the court should only consider evidence of the incompetent adult's intentions ifhis or her expressed pref­ erences were made during a period of competency. 280 see cruzan v. dir., mo. dep't ofhealth, 497 u.s. 261,282-83 (1990). in cruzan, the court stated, ''the function of a standard of proot;, as that concept is embodied in the due proc­ ess clause and in the realm offactfinding, is to 'instruct the factfinder concerning the degree of confidence our society thinks he should have in the correctness of factual conclusions for a par­ ticular type of adjudication."' id. at 282 (quoting in re winshop, 397 u.s. 358, 370 (1970)). ''this court has mandated an intermediate standard of proofclear and convincingwhen the individual interests at stake in a state proceeding are both 'particularly important' and 'more substantial than mere loss of money.'" !d. (quoting santosky v. kramer, 445 u.s. 745, 756 (1982)). 2007] harvesting organs from minors and incompetent adults 355 court should not continue with this approach for formerly competent adults. rather, the court should implement the standard set out in the following para­ graph for minors and never-before-competent adults.281 only by requiring a heightened standard such as clear and convincing evidence can it truly be de­ termined whether the incompetent individual had previously expressed his or her intentions and if so, what those intentions were. thus, the court will be protecting the incompetent individual from any attempt to impose society's val­ ues or the values of his family members or guardian onto him. by utilizing two different standards for once-competent individuals who are now incompetent and individuals who were never before competent, the court will truly be re­ specting the individual's autonomy. c. the standard for minors and never-before-competent incompetent adults when an incompetent individual has never been competent, as is the case with minors, courts should use an alternative standard for determining whether the harvesting of the minor's or incompetent adult's organ or tissue should be permitted. the court should look at a variety of factors and weigh these factors based on their relevance to the particular facts of the petition. 282 1. the donor's expressed preference first, the court should consider the donor's expressed preferences. the preference of the minor or incompetent may be used as evidence in determining what is best for the donor; however, this factor is not dispositive. like formerly competent incompetent adults, determining the donor's preferences under this standard similarly respects the minor or incompetent adult's personal auton­ omy. 283 furthermore, ascertaining the individual's preferences will help deter­ mine the psychological impact the procedure may have on the donor. for example, if the minor or incompetent adult expresses a strong desire not to do­ nate, it is unlikely that he or she will receive any psychological benefits as a result.284 although many commentators argue that any attempt to establish a minor or never-before-competent adult's preferences creates a fictional determination 281 see infra part vii.c (describing the standard for minors and never-before-competent incompetent adults). 282 not all factors will be relevant in every case. in such situations, the court shall disre­ gard irrelevant factors and give considerable weight to others. 283 see supra part v. minors' and never-before-competent individuals' preferences may be ascertained simply by asking the individual or may be inferred by the donor's set of values and beliefs. id. 284 see supra part v.b. 356 indiana health law review [vol. 4:319 of what the donor would decide if his or her values were more ascertainable,285 this contention no longer fmds support under this new standard. unlike the current approaches, determining an individual's preferences is not the end of the inquiry under this new test. under this standard, establishing an individ­ ual's preferences should be used as evidence to either bolster or defeat argu­ ments that debate what is best for the minor or incompetent adult. this factor is simply one factor among many, which the court should review before conclud­ ing that the harvesting procedure should be permitted. 2. physical benefit and harm associated with the harvest next, the court should consider the physical benefit and the physical harm to which the potential donor may be exposed by going forward with the trans­ plantation. in most cases, it is extremely rare that a healthy minor or incompe­ tent donor will receive any physical benefit.286 if either a long-term or short­ term physical benefit does exist, the court should consider it. likewise, long-term and short-term physical harm to the minor or incom­ petent donor must be minimal. as with any surgical procedure, there are risks associated with it, such as chances for infection as well as interactions with an­ esthetic.287 for example, a california baby conceived primarily for her bone marrow had to undergo multiple harvests and had to have a larger amount of bone marrow extracted from her body. 288 this means that she was repeatedly exposed to the risks associated with anesthetic. while these risks are generally considered slight,289 the court should hear testimony from medical professionals regarding a minor's or incompetent person's likelihood of permanent physical harm. furthermore, the court should consider whether the donor is in good physical health and whether the donor could function normally after recovering from the operation. 3. psychological benefit and harm associated with the harvest in addition to the physical effects ofthe procedure, the court should con­ sider the psychological impact of the harvest on the minor or incompetent adult. while a healthy individual will probably not receive any physical benefit from 285 griffith, supra note 38, at 303. 286 see curran v. bosze, 566 n.e.2d 1319, 1343 (ill. 1990); baronet al.,supranote 139. 287 see curran, 566 n.e.2d at 1344 ("[t]he risk of a life-threatening complication occurring from undergoing general anesthesia is 1 in 10,000 .... [t]he risks associated with general anesthesia include, but are not limited to, 'brain damage as a result of oxygen deprivation, stroke, cardiac arrest and death."'); shartle, supra note 11, at 438 (citing gale encyclopedia of medicine 497 (1st ed. 1999)). 288 trafford, supra note 2; see stewart, supra note 2. 289 shartle, supra note 11, at 438 (citing gale encyclopedia of medicine 497 (1st ed. 1999)). 2007] harvesting organs from minors and incompetent adults 357 the removal of an organ or tissue, 290 the psychological benefit or harm from the donation may be great. 291 therefore, the court should take into account any short-term or long-term psychological effects the minor or incompetent individ­ ual may experience. for example, a minor child may be able to grasp what it means to save a sibling's life and derive great satisfaction from the experi­ ence.292 in little, the court recognized studies indicating that donors benefit psychologically from donating an organ, including an increase in self-esteem and a renewed sense of worth in the family. 293 another reason that psychologi­ cal benefits should be considered is the need to avoid psychological devastation and guilt that accompanies the death of a sibling. 294 likewise, the court should consider the potential for psychological distress to the minor or incompetent donor. for example, some studies indicate that psychological distress becomes significant when the recipient's body rejects the organ or tissue.295 "[b]ecause the rejection rate for even closely matched kidneys can run as high as twenty percent, kidney donors may ... feel that they underwent major surgery and gave up a kidney for nothing."296 therefore, it is necessary that the minor or incompetent adult have some form of emotional stability or an emotional sup­ port system to help them handle the situation.297 although in certain circumstances, minors and incompetent adults may be unable to understand the nature of their altruistic acts,298 the court should still consider the potential psychological benefits and harms. if the court does not take into account psychological benefits but focuses solely on the medical bene­ fits to the minor or incompetent adult, the decision will never be in favor of the harvesting procedure. 299 this is because a healthy minor or incompetent adult will rarely benefit physically from having an organ or tissue harvested. 300 an alternative solution, however, such as prohibiting harvests from minors and incompetent adults altogether, is not proper either. a per se rule preventing harvesting procedures frustrates these individuals' ability to ever act altruisti­ cally.301 such regulation imposes narrow self-seeking values on individuals who may have broader, altruistic ideals.302 290 see curran, 566 n.e.2d at 1343; baronet at., supra note 139, at 170. 291 cheyette, supra note 32, at 471. 292 see id. 293 little v. little, 576 s.w.2d 493,499 (tex. app. 1979). 294 cheyette, supra note 32, at 471. 295 morley, supra note 116, at 1223; see cheyette, supra note 32, at 475. 296 cheyette, supra note 32, at 479. 297 see curran v. bosze, 566 n.e.2d 1319, 1343 (ill. 1990). 298 griner, supra note 67, at 600. 299 see dufault, supra note 8, at 237. 300 see curran, 566 n.e.2d at 1343; dufault, supra note 8, at 237. 301 see in re pescinski, 226 n.w.2d 180, 184 (wis. 1975) (day, j., dissenting). 302 see id. 358 indiana health law review [vol. 4:319 4. the recipient is likely to benefit from the transplant although there is much debate about whether courts should focus solely on the benefit and harm to the donor,303 it is necessary to detennine whether the recipient is likely to benefit from the transplant as well. this factor is essential to the court's analysis because the experience of donating an organ is unlikely to produce any psychological benefit to the minor or incompetent donor if the transplant has no reasonable chance of saving or prolonging the recipient's life. thus, the court need not delve into the psychological realm of the minor's or incompetent adult's ability to comprehend the grief associated with the loss of a sibling. to determine whether the transplant has a reasonable probability of success, courts should hear medical testimony from the recipient's doctors about the recipient's condition, the chances of the organ being rejected, and the likelihood that the transplant will produce any long-term benefits to the recipient. 5. the potential donor and potential recipient have an existing relationship the presence or absence of an ongoing social and emotional relationship should be another factor the court considers before pennitting an organ or tissue harvest. 304 absent such a relationship, the court is unable to conclude that the donor will experience any psychological benefit as a result of the procedure. 305 when both a physical and a psychological benefit are lacking, the harvest peti­ tion will inevitably be denied due to its inadequate foundation under this stan­ dard. in cu"an, the court noted that the existence of an established relationship "as well as the potential for a continuing ... relationship," is necessary in order for the court to find that a psychological benefit exists.306 additionally, the court concluded that a "psychological benefit is grounded finnly in the fact that the donor and recipient are known to each other as family.'.j07 although a blood relationship is not necessary, 308 the requirement of a close relationship between the donor and the recipient will protect minors and incompetent adults 303 see griner, supra note 67, at 607. 304 see curran, 566 n.e.2d at 1344. 305 see id. 306 ld. 307 id. 308 a blood relationship is not necessary because adopted siblings can have just as inti­ mate of a relationship with their siblings as blood-related siblings. see smith v. org. of foster families for equal. and reform, 431 u.s. 816, 844 (1977) (''thus the importance of the :filmilial relationship, to the individuals involved and to the society, stems from the emotional attach­ ments that derive from the intimacy of daily association, and from the role it plays in 'pro­ mot(ing) a way oflife' .•. as well as from the tact of blood relationship."). 2007] harvesting organs from minors and incompetent adults 359 from being used as donors for third party strangers. the parameters of this requirement also allows for donation in cultures where the concept of family is broadly defined. this alleviates "the fear expressed that institutions for the mentally ill will merely become storehouses for spare parts for people on the outside .... "309 because a psychological benefit will only realistically exist when there is an ongoing relationship between the potential donor and potential recipient,310 the absence of such relationship should preclude the transplantation. viii. conclusion while the substituted judgment doctrine and the best interest standard have been the standards used for many years, both tests produce nothing more than irrational and illogical decisions. not only will the proposed solution pro­ vide courts with guidance when faced with a formerly competent individual, but also, it will grant individuals the respect and personal autonomy they de­ serve. although this proposed solution does not end the debate concerning the duty to rescue and harvesting procedures, an absolute prohibition against har­ vesting procedures fails to recognize that these individuals may choose to act altruistically. finally, because parental consent is so closely scrutinized under this standard and because the adversarial process will be used in all situations, it is anticipated that parents who intend to use a fetus as an organ farm will be deterred from engaging in this practice. understandably, minors and incompetent adults need the assistance of parents, guardians, and courts when making medical decisions. although the right to parental control and familial autonomy is given great deference in this area, the court should not hesitate to exercise its parens patriae power when these rights are abused. when minors and mentally incompetent adults neither voluntarily donate their organs nor consent to the harvest, a petition from a par­ ent or guardian seeking to compel the transplant is undeniably problematic. in such a situation, courts have both a legal and ethical duty to protect our most vulnerable members of society from potentially depraved and coercive prac­ tices. 309 in re pescinski, 226 n.w.2d 180, 183 (wis. 1975) (day, j., dissenting). 31° curran, 566 n.e.2d at 1344. microsoft word 1-masthead vol. viii.doc hospital tax-exemption and the community benefit standard: considerations for future policymaking bobby a. courtney* i. introduction ............................................................................... 366 a. the issue .................................................................................. 366 b. roadmap .................................................................................. 367 ii. background ................................................................................ 368 a. evolution of the community benefit standard ......................... 368 1. the early years ................................................................. 368 2. the later years ................................................................. 369 b. modern reaction to the community benefit standard ............ 371 1. the states weigh in ........................................................... 371 2. the irs takes a hard look .............................................. 372 3. congress takes aim .......................................................... 374 iii. moving forward ........................................................................ 376 a. why does the community benefit standard matter? .............. 376 b. is there really any difference between nonprofit and for-profit hospitals?............................................................... 377 1. financial indicators .......................................................... 377 2. quality indicators.............................................................. 378 3. behavioral indicators ........................................................ 378 4. implications ....................................................................... 379 c. mandatory charity care percentages ..................................... 379 d. medicare shortfall, bad debt, and community-building activities ................................................................................... 381 1. the current state of affairs .............................................. 381 2. bad debt & medicare shortfall ........................................ 382 a. bad debt ...................................................................... 383 (i) amount determination. ....................................... 384 (ii) improved processes. ........................................... 385 b. medicare shortfall. ...................................................... 387 3. community-building activities .......................................... 390 iv. maintaining irs control ......................................................... 392 v. conclusion .................................................................................. 394 vi. addendum .................................................................................... 396 * j.d./m.p.h. candidate, 2012, indiana university school of lawindianapolis; b.a., 1999, university of illinoisurbana; m.a., 2001, bradley university. this note received the 2010, indiana state bar association health law section’s distinguished writing award. 366 indiana health law review [vol. 8:2 i. introduction the boston globe recently reported that in 2007, ten of massachusetts’ leading hospital companies received approximately $638 million in tax incentives and state borrowing discounts, exceeding the value of “community benefits” (i.e., indigent care and other charity work) they provided by more than $264 million that same year.1 without further analysis, this discrepancy appears at odds with a general principle of nonprofit taxexemption; specifically, that “the government’s loss of tax revenues is offset by its relief from financial burdens that it would otherwise have to meet with appropriations from public funds, and by the benefits resulting from the promotion of general welfare.”2 however, during this same year the largest of these companies provided care to medicare patients at a loss of approximately $400 million, care to medicaid patients at a loss of nearly $145 million, and care to self-pay patients at a loss of over $40 million.3 additionally, the company continues to invest significant resources in community-based partnerships aimed at addressing health disparities; programs that improve the health of women through emergency shelter, social support, and educational opportunities; community workforce development programs; and services for homeless adults and veterans.4 should these unreimbursed costs and other community services be considered as part of the tax-exemption calculus? if so, to what extent? certainly not limited to massachusetts, this question continues to spur significant debate over the extent to which nonprofit hospitals “deserve” their tax-exempt status. a. the issue the issue of hospital tax-exemption is particularly important given the over 50 million citizens without health insurance in the united states.5 historically, the uninsured have relied on the charity of private hospitals (i.e., not government owned) for care.6 these private hospitals are largely non 1. scott allen & marcella bombardieri, much is given by hospitals, more is asked, the bos. globe, may 31, 2009, at a1. 2. u.s. gov’t accountability office, gao-08-880, nonprofit hospitals: variation in standards and guidance limits comparison of how hospitals meet community benefit requirements 10 (2008), available at http://www.gao.gov/new.items/ d08880.pdf. see generally 26 c.f.r. § 1.501(c)(3)-1 (2009). 3. partners healthcare, partners healthcare community benefits overview 15 (2007), available at http://www.cbsys.ago.state.ma.us/healthcare/hccbar.asp ?section=15&head2=community+benefits&head3=hospital+and+hmo+reports& cbsysappctx=reportfulltext&cbsyssubctx=download&filetype=pdf&reportid=65%2d2008. 4. id. at 5-11. 5. carmen denavas-walt et al., u.s. census bureau, p60-238, income, poverty, and health insurance coverage in the united states: 2009, at 24 (2010), available at http://www.census.gov/prod/2010pubs/p60-238.pdf. 6. mark a. hall & john d. colombo, the charitable status of nonprofit hospitals: 2011] hospital tax-exemption and the community benefit standard 367 profit; in fact, “[o]f the 630,000 beds in medicare-certified community hospitals in the united states in 2003, 68 percent were located in nonprofit hospitals, 16 percent were located in for-profit hospitals, and 15 percent were located in government (nonfederal) facilities.”7 moreover, the american hospital association notes that there are over 5,700 hospitals in the united states, more than 2,900 of which are nonprofit, non-governmental facilities.8 given both shrinking reimbursement by government and private payers, and increasingly competitive markets, the cost of unreimbursed care continues to mount and nonprofit hospitals are finding it more difficult to cross-subsidize indigent care (i.e., charity care) using revenues garnered from paying patients.9 as such, a perception exists that many nonprofit hospitals do not warrant their tax-exempt status, since their direct charity care figures do not equal the financial benefit these entities receive from said exemption. b. roadmap this note does not purport to analyze or recommend new constructs upon which charitable exemption should be based; rather, it offers a pragmatic discussion of elements that should be included when considering taxexemption as applied to nonprofit hospitals. to facilitate such a discussion, part ii addresses the evolution of tax-exemption for nonprofit hospitals, criticism of the current standard, as well as state, internal revenue service (“irs”), and congressional responses to the issue. part iii suggests that any future standard should exclude a mandatory charity care percentage, yet include bad debt, the unreimbursed cost of medicare, and hospital “community-building” activities. finally, part iv recommends that the locus of control for defining the standard should remain with the irs. toward a donative theory of tax exemption, 66 wash. l. rev. 307, 315 (1991). see generally douglas m. mancino, symposium: health care and tax exemption: the push and pull of tax exemption law on the organization and delivery of health care services: the impact of federal tax exemption standards on health care policy and delivery, 15 health matrix 5 (2005). 7. cong. budget office, 109th cong., pub. no. 2707, nonprofit hospitals and the provision of community benefits 3 (2006), available at http://www.cbo.gov/ftpdocs/ 76xx/doc7695/12-06-nonprofit.pdf. 8. steven t. miller, comm’r, tax exempt and gov’t entities, internal revenue serv., u.s. dep’t of the treasury, remarks before the office of the attorney general of texas 2 (jan. 12, 2009), available at http://www.irs.gov/pub/irs-tege/miller_speech_ 011209.pdf. 9. hall & colombo, supra note 6, at 315. 368 indiana health law review [vol. 8:2 ii. background a. evolution of the community benefit standard 1. the early years the history of american hospital tax-exemption has been widely addressed in legal scholarship.10 hospitals are not per se tax-exempt under the internal revenue code, rather receipt of such benefits is grounded in an organization’s designation as “charitable” under § 501(c)(3).11 generally speaking, qualification for exemption under this section requires that a hospital: 1) be organized and operated exclusively for charitable purposes; 2) not use any part of its net earnings for the benefit of any private person; and 3) adhere to certain statutory limitations regarding legislative lobbying and participation in political campaigns.12 one might expect these requirements to include the provision of free health care services; however, charitable is a term of art never expressly defined by congress.13 as such, a hospital’s nonprofit status under §501(c)(3) was historically dependent upon an irs finding that it was “engaged in relief of the poor or distressed . . . .”14 in 1956, the irs announced a substantive rule of charitable purpose.15 specifically, revenue ruling 56-185 permitted nonprofit hospitals to charge patients, but conditioned tax-exemption on the provision of charity care “to the extent of [the hospital’s] financial ability.”16 the ruling went on to note that a low charity care record is not dispositive; however, the requirement is not met simply because the hospital expects, but does not receive, full payment for services.17 although the ruling did not provide a formula for assessing a hospital’s charity care and the irs has never taken an official position on how much actual charity care was required, “if a hospital lacked a substantial charity care program, auditing agents almost always recommended denial or revocation of exempt status.”18 10. see generally jill r. horwitz, does nonprofit ownership matter?, 24 yale j. on reg. 139 (2007); jack e. karns, justifying the nonprofit hospital tax exemption in a competitive market environment, 13 widener l.j. 375 (2004); and daniel m. fox & daniel c. schaffer, tax administration as health policy: hospitals, the internal revenue service, and the courts, 16 j. health pol’y & l. 251 (1991) (all articles examine the history of the law of “charity,” as well as american charitable tax policy related to nonprofit hospitals). 11. 26 u.s.c. § 501(c)(3) (2006). 12. john d. colombo, are associations of doctors tax-exempt? analyzing inconsistencies in the tax-exemption of health care providers, 9 va. tax rev. 469, 474-75 (1990). 13. id. at 475. 14. id. 15. see rev. rul. 56-185, 1956-1 c.b. 202, available at http://www.irs.gov/pub/irstege/rr56-185.pdf. 16. id. (alteration in original). 17. id. 18. john d. colombo, symposium: health care and tax exemption: the push and pull of tax exemption law on the organization and delivery of health care services: the 2011] hospital tax-exemption and the community benefit standard 369 the substantive test established in revenue ruling 56-185 remained until 1969, when the irs announced revenue ruling 69-545, presently referred to as the “community benefit standard.”19 written while congress was considering medicare and medicaid legislation, it has been asserted that this ruling was a direct response to complaints from the hospital industry that the combination of private insurance and the new public insurance programs would reduce the overall demand for charity care, making it difficult for hospitals to satisfy the irs’s exemption requirement.20 the new ruling stated that the general law of charity considered promotion of health a charitable purpose; therefore, “[a] nonprofit organization whose purpose and activity are providing hospital care is promoting health and may . . . qualify as organized and operated in furtherance of a charitable purpose.”21 revenue ruling 69-545 further identified five key factors to be considered when determining whether a hospital qualifies for exemption under section 501(c)(3), namely, does the hospital: (1) operate an emergency room open to all persons regardless of ability to pay; (2) provide care to all persons able to pay directly or through insurance; (3) serve a public interest; (4) maintain an open medical staff; and (5) use surplus revenues to improve the quality of care, facilities, medical training, education, and research.22 determinations were to be made after consideration of “all of the relevant facts and circumstances in each case,” with the absence of particular factors, or the presence of others, not necessarily being determinative.23 2. the later years academics have suggested that the irs began to undermine its standard almost immediately after adoption.24 in 1973, sound health association (“sound health”), a “staff model” nonprofit health maintenance organization (“hmo”) was denied tax-exemption under section 501(c)(3).25 under this model, sound health employed salaried clinicians, contracted with secondary providers, and administered nearly all services at failure of community benefit, 15 health matrix 29, 30 (2005). 19. john m. quirk, turning back the clock on the health care organization standard for federal tax exemption, 43 willamette l. rev. 69, 74 (2007). see generally robert s. bromberg, the charitable hospital, 20 cath. u. l. rev. 237 (1970). 20. colombo, supra note 18, at 30-31. 21. rev. rul. 69-545, 1969-2 c.b. 117, available at http://www.irs.gov/pub/irs-tege/ rr69-545.pdf. 22. id. 23. id. 24. see generally colombo, supra note 18; mancino, supra note 6. 25. sound health ass’n v. comm’r, 71 t.c. 158, 172 (t.c. 1978) (in 1973, sound health opened its clinic to nonmembers on a fee-for-service basis, and began providing emergency services without regard to the patient’s ability to pay. moreover, sound health initiated a subsidy program for nonmembers who failed to meet medicaid’s minimum income requirements, yet still could not afford the association’s dues.). 370 indiana health law review [vol. 8:2 its own clinic.26 moreover, it provided services to both members and nonmembers regardless of their ability to pay.27 despite this structure and clear congressional preference for such organizations,28 a final irs ruling declared that sound health’s members would receive preferential treatment and that a prepayment feature for members did not further a public charitable purpose.29 however, the tax court disagreed noting that the provision of medical care is a charitable activity and that the tests applied to determine hospital exemption are relevant to hmos.30 the court went on to hold that there was no significant preferential treatment resulting in private benefit to the organization’s “insiders,” and that membership was “not so limited that the community as a whole [would] not benefit.”31 in the early 1990s, the irs challenged the charitable exemption of another hmo, geisinger health plan (“geisinger”).32 in contrast to sound health, geisinger was organized as a “contractual model” (meaning it maintained provider contracts with third party health professionals)33 with a limited charity care program.34 hoping to capitalize on these differences, the irs’s arguments were again rejected by the tax court, which held that geisinger’s membership was unlimited, provided a community benefit, and was not operated for private benefit.35 however, on appeal, the third circuit reversed finding the community benefit was limited to geisinger members “since the requirement of subscribership remain[ed] a condition precedent to any service.”36 in addition, the plan’s charity care offering in the form of a subsidized dues program was miniscule and would only cover thirty-five people, as compared to approximately 70,000 paying members.37 almost ten years after the geisinger decision, the tax court heard a series of cases concerning the tax-exempt status of three intermountain health care (“ihc”) system subsidiary hmos.38 in each case, the tax court held against a grant of exemption for failure to provide a community 26. id. 27. id. 28. see health maintenance organization act of 1973, pub. l. no. 93-222 (codified as amended at 42 u.s.c. § 300e (2006)). 29. sound health ass’n, 71 t.c. at 176. 30. id. at 178-79. 31. id. at 189-90 (alteration in original). 32. geisinger health plan v. comm’r, t.c.m. (ria) 91649 (1991). 33. peter r. kongstvedt, the managed health care handbook 38 (aspen publishers, 4th ed. 2001) (1985). 34. geisinger health plan, t.c.m. (ria) 91649 at 18, 32-34. 35. id. at 36-37. 36. geisinger health plan v. comm’r, 985 f.2d 1210, 1219 (3d cir. 1993) (alteration in original). 37. id. at 1220. 38. see generally ihc care v. comm’r, 82 t.c.m. (cch) 617 (2001); ihc group, inc. v. comm’r, 82 t.c.m. (cch) 606 (2001); ihc health plans, inc. v. comm’r, 82 t.c.m. (cch) 593 (2001); ihc health plans, inc. v. comm’r, 325 f.3d 1188 (10th cir. 2003). 2011] hospital tax-exemption and the community benefit standard 371 benefit and specifically highlighted the lack of charity care in the hmo’s operations. on appeal, the tenth circuit affirmed, noting that ihc provided “virtually no free or below-cost health-care services.”39 professor john colombo argues that the position taken by the irs in sound health ran counter to the broad language of revenue ruling 69-545, and that “simply providing health care to all paying patients was insufficient to warrant exemption.”40 moreover, the third circuit’s decision in geisinger “signaled that the community benefit test . . . was inadequate to distinguish ‘charitable’ health care from ‘non-charitable’ health care.”41 these initial cases, coupled with the subsequent ihc rulings, illustrate that something more like “health care plus,” arguably a substantial charity care program, is required.42 b. modern reaction to the community benefit standard 1. the states weigh in state income tax laws largely derive from section 501(c)(3) of the internal revenue code; however, state property and sales tax exemptions typically have their own standards.43 as such, exemption under the code does not necessarily entail a state property or sales tax exemption.44 the former is of great importance to hospitals given that they “are often highly capitalintensive businesses with significant property holdings.”45 while most states have historically recognized nonprofit community hospitals as being exempt from property taxes,46 a series of cases and legislation beginning in 1985 illustrate a growing concern that nonprofit hospitals are not providing charity care sufficient to meet exemption. in utah county v. intermountain health care, inc., the utah supreme court upheld the exemption revocation of several hospitals, noting they had not “demonstrated any substantial imbalance between the value of the services [provided] and the payments it receives apart from any gifts, donations, or endowments.”47 specifically, the charity care provided by the hospitals was less than one percent of their gross revenues, and was not in 39. ihc health plans, inc. v. comm’r, 325 f.3d 1188, 1200 (10th cir. 2003). 40. colombo, supra note 18, at 32. 41. id. at 34. 42. id. at 36-37, 40. 43. john colombo, federal and state tax exemption policy, medical debt and healthcare for the poor, 51 st. louis u. l.j. 433, 436 (2007). 44. id. 45. id. 46. id. at 440. 47. utah cnty. by and through cnty. bd. of equalization v. intermountain health care, inc., 709 p.2d 265, 274 (utah 1985) (alteration in original). 372 indiana health law review [vol. 8:2 tentionally advertised due to fears that patients would take advantage of it.48 several years later, the texas legislature passed a law setting financial guidelines for charity care provided by tax-exempt hospitals.49 although not as stringent as the texas guidelines, a number of states have also enacted legislation either mandating or making voluntary hospital community benefit reporting (e.g., california, idaho, illinois, indiana, maryland, and new york).50 most recently, publicity generated by the revocation of two illinois hospitals’ state property tax-exemptions,51 resulted in draft legislation establishing debt collection regulation and strict charity care requirements.52 while the latter were eventually withdrawn, they would have imposed an obligation on nonprofit hospitals to provide charity care equal to or greater than eight percent of the hospital’s total operating costs.53 2. the irs takes a hard look in response to calls for increased transparency in the nonprofit sector by senators max baucus and chuck grassley,54 the irs recently revised form 990, “the primary mechanism used to monitor exempt organizations’ compliance with federal tax law.”55 “[c]hanges include[d] an overhaul of 48. id. 49. colombo, supra note 43, at 442. see also tex. health & safety code ann. §§ 311.041–311.048 (west 2010). 50. cal. health & safety code §§ 127350, 127355 (deering 2010), idaho code ann. § 63-602d (2010); 210 ill. comp. stat. ann. 76/15, 76/20 (lexisnexis 2010); ind. code ann. §§ 16-21-9-4–16-21-0-7 (lexisnexis 2010); md. code ann., health-gen. § 19-303 (lexisnexis 2010); n.h. rev. stat. ann. §§ 7:32-e–7:32-g (lexisnexis 2010); n.y. pub. health law § 2803-l (consul. 2010). 51. in 2004, the champaign, illinois county board of review recommended revocation of property tax-exemption for provena covenant medical center in urbana, illinois. the board made a similar recommendation in 2005 for carle hospital in urbana. in both cases, the board found that the hospitals failed to meet their charity-care obligations. specifically, both were: 1) charging uninsured patients two to five times what insured patients were charged for the same services; 2) using aggressive collection practices, which included suing patients; 3) providing limited charity care (less than one half of one percent of total revenues in one case); and 4) involved in intimate business relationships with directly related forprofit entities. provena’s exemption was eventually revoked by the illinois department of revenue, a decision that was upheld on appeal to the illinois supreme court. see generally provena covenant med. ctr. v. dep’t of revenue, 925 n.e.2d 1131 (ill. 2010); hearing on the tax-exempt hospital sector before the h. comm. on ways and means, 109th cong., 9298 (may 26, 2005) (statement of stan jenkins, chairman, champaign county board of review) available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_ house_ hearings&docid=f:26414.pdf; john colombo, hospital property tax exemption in illinois: exploring the policy gaps, 37 loy. u. chi. l.j. 493 (2006). 52. see h.r. 5000, 94th gen. assem., reg. sess. (ill. 2006); h.r. 4999, 94th gen. assem., reg. sess. (ill. 2006). 53. colombo, supra note 43, at 444. 54. see press release, sen. grassley works to build confidence in nonprofits with greater transparency (may 29, 2007), available at http://grassley.senate.gov/news/article .cfm?customel_datapageid_1502=12581. 55. eileen salinsky, nat’l health policy forum, the george washington 2011] hospital tax-exemption and the community benefit standard 373 the ‘core form’ that captures select information regarding exempt organizations’ financial status, governance, staffing, and employee compensation, as well as the creation of several schedules which seek to standardize reporting for information that had previously been provided through filer-designed attachments.”56 schedule h of form 990 in particular will require nonprofit hospitals to provide the irs with detailed information, using standardized definitions, describing their charitable efforts beginning in 2009 (reporting tax year 2008).57 schedule h is organized into six parts, based in large part on voluntary reporting guidelines originally developed by the catholic health association.58 specific reporting sections include: 1) charity care and certain other community benefits; 2) community building activities; 3) bad debt, medicare, and collection practices; 4) management companies and joint ventures; 5) facility information; and 6) supplemental information.59 moreover, schedule h provides clear standards with respect to the types of activities reportable as community benefit and how such activities should be reported (costs rather than charges).60 schedule h does not “provide a bright line standard against which the reported data can be assessed to determine whether the reporting hospital should be tax-exempt or should be taxed.”61 in addition to revising form 990, the irs initiated a hospital compliance project in may 2006 to study community benefit and executive compensation.62 the project consisted of surveying over 500 nonprofit hospitals, classified by community type, revenue size, as well as health insurance coverage and per capita income of the surrounding area.63 several key findings from the report were as follows: 1) the average percentage of total revenues spent on combined community benefit was nine percent; 2) community benefit expenditures were not evenly distributed, as nine percent of the hospitals, mainly large and urban hospitals, reported sixty per univ., background paper no. 67, schedule h: new community benefit reporting requirements for hospitals 4 (2009), available at http://www.nhpf.org/library/ background-papers/bp67_scheduleh_04-21-09.pdf. 56. id. (alteration in original). 57. id. 58. id. at 6. see generally catholic health ass’n of the u.s., the irs form 990, schedule h: community benefit and catholic health care governance leaders (2009), available at http://www.chausa.org/workarea/linkit.aspx?linkidentifier=id&itemid =978 (the catholic health association has been a proponent of the community benefit role of nonprofit health care providers for over twenty years and worked closely with the internal revenue service in its development of the new reporting requirements.). 59. internal revenue serv., dep’t of the treasury, omb no. 1545-0047, schedule h (form 990), hospitals (2010), available at http://www.irs.gov/pub/irs-pdf/ f990sh.pdf. 60. see miller, supra note 8, at 9-10. 61. id. at 10 (alteration in original). 62. internal revenue serv., dep’t of the treasury, irs exempt organizations (te/ge) hospital compliance project final report 1 (2009), available at http://www.irs.gov/pub/irs-tege/frepthospproj.pdf. 63. id. at 1-3. 374 indiana health law review [vol. 8:2 cent of the community benefit expenditures; 3) uncompensated care was the largest component of community benefit at fifty-six percent, and was greatest for critical access, rural, and small hospitals; 4) medical education and training expenditures represented twenty-three percent of the community benefit, research expenditures represented fifteen percent, and community programs six percent; and 5) aggregate profit margin was five percent, with twenty-one percent of hospitals reporting a deficit.64 however, the study was not without its limitations given that the data were not independently verified,65 and the irs did not limit what could be included within a reportable category.66 as such, expenditures reported by some hospitals may overstate what will actually be reported on the upcoming schedule h, due to their inclusion of uncompensated care as charges, bad debt, medicare shortfalls, and private insurance shortfalls.67 3. congress takes aim the community benefit standard has come under increased scrutiny by federal lawmakers in recent years. beginning in 2004, the subcommittee on oversight of the house ways and means committee held hearings on hospital pricing, which included discussions related to charity care and the differences in services offered by nonprofit versus for-profit hospitals.68 a year later, the full committee held hearings specifically related to nonprofit hospital tax-exemption,69 which subsequently resulted in two research reports by the congressional budget office entitled, nonprofit hospitals and the provision of community benefits and nonprofit hospitals and tax arbitrage. the former addresses the type and amount of community benefit provided by nonprofit hospitals,70 while the latter examines the use of taxexempt bonds by nonprofit hospitals.71 despite this interest by the house committee on ways and means, senator chuck grassley, ranking member of the senate finance committee, has been the most vocal in his concern that nonprofits may not be deserving of their tax-exempt status. 64. id. at 3-5. 65. id. at 2. 66. miller, supra note 8, at 11. 67. internal revenue serv., supra note 62, at 2. 68. see generally pricing practices of hospitals, hearing before the subcommittee on oversight of the h. comm. on ways and means, 108th cong. (2004), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_house_hearings&docid=f: 99670.pdf. 69. see generally hearing on the tax-exempt hospital sector before the h. comm. on ways and means, 109th cong. (2005) available at http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname=109_house_hearings&docid=f:26414.pdf. 70. see generally cong. budget office, supra note 7. 71. see generally cong. budget office, 109th cong., nonprofit hospitals and tax arbitrage (2006), available at http://www.cbo.gov/ftpdocs/76xx/doc7696/12-06hospitaltax.pdf. 2011] hospital tax-exemption and the community benefit standard 375 in may 2005, senator grassley conducted an inquiry into nonprofit hospital charity care policies, compensation policies, and types of community benefit provided, by sending letters to ten of the largest u.s. nonprofit hospitals requesting that they account for their charitable activities in light of their tax-exempt status.72 results of senator grassley’s survey demonstrated that nonprofit hospitals generally have no consistent methodology for measuring community benefit.73 as a result, the senator sought a staff report to aid finance committee members in the development of proposals to address the issue.74 the staff report was released in july 2007 and recommended development of specific standards for hospitals seeking exemption under section 501(c)(3) including, but not limited to, quantitative standards for charity care; limitations on charges billed to uninsured patients; transparency and accountability requirements; and sanctions for failure to comply with requirements under the section.75 in may 2009, pursuant to the senate finance committee’s efforts to develop health care reform legislation, committee chairman senator max baucus and senator grassley distributed a number of policy options for the committee’s consideration.76 among the options proposed was a recommendation to “codify organizational and operational requirements for determining whether a hospital is a charitable organization for purposes of section 501(c)(3) tax-exempt status.”77 specifically, hospitals would be required to: 1) conduct regular community needs assessments; 2) meet minimum charity care levels; 3) provide services regardless of a patient's inability to pay; and 4) “follow certain procedures before instituting collection actions against patients.”78 exemptions would be allowed for “[c]ertain hospitals that are critical to the communities they serve or which have an independent basis for tax exemption,” such as classification as an educational or research organization; however, those not meeting the enumerated requirements would face intermediate sanctions designed to encourage compliance.79 72. see press release, grassley asks non-profit hospitals to account for activities related to their tax-exempt status (may 27, 2005), available at http://grassley.senate.gov/ news/article.cfm?customel_datapageid_1502=12892. 73. press release, grassley directs effort to ensure more charitable care from nonprofit hospitals (sept. 13, 2006), available at http://grassley.senate.gov/news/article.cfm? customel_datapageid_1502=9773. 74. id. 75. see staff of s. comm. on fin. minority, 110th cong., tax-exempt hospitals: discussion draft 2 (comm. print 2007), available at http://grassley.senate.gov /releases/2007/07182007.pdf. 76. see s. fin. comm., 111th cong., financing comprehensive health care reform: proposed health system savings and revenue options (comm. print 2009), available at http://finance.senate.gov/download/?id=d8b0f79c-ea88-49cb-96f8-1d6cf6c5 b577. 77. id. at 33. 78. id. 79. id. at 33-34. 376 indiana health law review [vol. 8:2 on september 22, 2009, the chairman’s mark was released entitled, america’s healthy future act of 2009.80 the mark included requirements for community needs assessments, financial assistance policies, charge limitations, collection policies, as well as reporting and disclosure; however, a charity care standard and a broad sanctions scheme were left out.81 in response, senator grassley noted that a mandatory charity percentage requirement would likely “become a ceiling, not a floor” and, therefore, additional study was necessary to devise a formula that maximizes nonprofit hospital expenditures for charitable purposes.82 according to steven t. miller, commissioner, tax exempt and government entities at the irs, “senator grassley continues to discuss the possibility of introducing legislation in this area.”83 iii. moving forward a. why does the community benefit standard matter? a 2006 congressional budget office report estimated that the value of major tax-exemptions provided to nonprofit hospitals through federal, state, and local governments was approximately $12.6 billion in 2002.84 this figure consists of $2.5 billion in federal corporate income tax-exemptions, $1.8 billion in federal tax-exempt-bond financing, $1.8 billion in charitable contributions (federal), $500 million in state corporate income tax exemptions, $2.8 billion in state and local sales tax exemptions, and $3.1 billion in local property tax exemptions.85 moreover, according to recent irs data concerning public charity tax filings, “nonprofit hospitals accounted for revenues of $451.3 billion (41.6% of total public charity revenues) and assets of $551.6 billion (28.5% of total public charity assets).”86 given these figures, it is no surprise that one would question the extent to which nonprofit hospitals are earning their charitable status. nevertheless, in recent years, legal scholarship87 and congressional efforts88 have, for the reasons 80. america’s healthy future act of 2009, s.1796, 111th cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s1796 pcs.txt.pdf. chairman’s mark is a “[r]ecommendation by committee (or subcommittee) chair of the measure to be considered in a markup, usually drafted as a bill.” chairman’s mark/staff draft, thecapitol.net, http://www.thecapitol.net/glossary/c.htm#chairman's% 20mark/staff%20draft (last visited mar. 17, 2011). 81. id. see generally s. fin. comm., supra note 76. 82. press release, grassley welcomes non-profit hospital provisions in chairman’s health care reform bill (sept. 17, 2009), available at http://grassley.senate.gov/news/ article.cfm?customel_datapageid_1502=23094. 83. miller, supra note 8, at 8. 84. cong. budget office, supra note 7, at 5. 85. id. 86. horwitz, supra note 10, at 146. 87. see terri l. brooks, billions saved in taxes while millions underserved – what 2011] hospital tax-exemption and the community benefit standard 377 explained below, incorrectly suggested legislation aimed at increasing nonprofit hospital responsibility in order to maintain tax-exempt status. b. is there really any difference between nonprofit and for-profit hospitals? despite being bound by section 501(c)(3)’s qualifications for taxexemption, most notably the non-distribution constraint,89 a perception exists that nonprofit hospitals are no different than their for-profit counterparts, and therefore are undeserving of exemption. as such, numerous studies have considered whether ownership type influences financial performance, patient outcomes, and likelihood of providing certain services. 1. financial indicators in 2006, the national bureau of economic research conducted a meta-analysis of empirical literature investigating the effect of hospital ownership on financial performance (e.g., cost, revenue, profit margin, and efficiency).90 their analysis found that diverse results among the literature could be explained largely by “differences in authors’ underlying theoretical frameworks, assumptions about the functional form of the dependent variables, and model specifications.”91 those studies using weaker methods and functional forms tended to predict greater divergence in financial performance among ownership types; however, combined estimates suggested for-profit hospitals generate greater revenue, albeit modest in terms of economic significance, than their nonprofit counterparts.92 moreover, a summary of several studies on gross uncompensated care data illustrates little difference between nonprofit and for-profit hospitals, as well as “little difference between preand post-conversion levels of charity care in nonprofit to for-profit conversion transactions.”93 has happened to charitable hospitals?, 8 hous. bus. & tax l. j. 391 (2008); laura l. folkerts, do nonprofit hospitals provide community benefit? a critique of the standards for providing deservedness of federal tax exemptions, 34 iowa j. corp. l. 611 (2009). 88. see generally staff of s. comm. on fin. minority, supra note 75; s. fin. comm., supra note 76. 89. see generally henry b. hansmann, the role of nonprofit enterprise, 89 yale l. j. 835 (1980) (noting that nonprofit organizations are barred from distributing net earnings). 90. karen eggleston et al., hospital ownership and financial performance: a quantitative research review 2 (nat’l bureau of econ. res. working paper no. 11662, 2005), available at http://www.nber.org/papers/w11662. 91. id. at 2. 92. id. at 1. 93. colombo, supra note 18, at 49. 378 indiana health law review [vol. 8:2 2. quality indicators regarding the effect of hospital ownership on quality of care, a vast body of literature provides conflicting evidence.94 based on a quantitative review of studies conducted since 1990, researchers indicate that divergent results are largely based on analytic methods.95 specifically, study features such as “disease or outcome studied, whether or not the study adjusted for patient comorbidities, and data sources” tend to explain the differences among attempts to compare patient outcomes between nonprofit and forprofit hospitals.96 moreover, researchers “found no systematic differences in estimated ownership effects between studies that did and did not examine ownership conversions,” and “regions covered explained little of the variation in studies of patient outcomes . . . .”97 3. behavioral indicators an article by professor jill horwitz demonstrates that, “hospital types differ in their provision of medical services because they are more or less profit-seeking . . . .”98 in other words, hospitals provide services based on their overall goals and objectives. with respect to consistently profitable services such as open-heart surgery, for-profits are more likely than nonprofits to offer such services.99 for consistently unprofitable services, such as psychiatric emergency care, data illustrate the exact opposite, in that forprofits are less likely than nonprofits to provide such services.100 finally, concerning services with variable profitability such as home health care, “for-profit responsiveness to financial incentives is strong and quick – likely because for-profits are relatively more profit-seeking . . . .”101 criticism is often leveled at nonprofit hospitals for this type of market behavior, as if they are undeserving of their tax-exempt status “merely because the market requires that sound business strategies be employed by all entities seeking to survive, if not thrive.”102 94. karen eggleston et al., hospital ownership and quality of care: what explains the different results 2 (nat’l bureau of econ. res. working paper no. 12241, 2006), available at http://www.nber.org/papers/w12241. 95. id. at 16. 96. id. 97. id. at 17. 98. horwitz, supra note 10, at 171. 99. id. at 171-72. 100. id. at 173-74. 101. id. at 174. 102. karns, supra note 10, at 494. 2011] hospital tax-exemption and the community benefit standard 379 4. implications the above assessment demonstrates that traditional measures of comparison show little difference between for-profit and nonprofit hospitals. however, managerial behaviors have been shown to differ.103 for example, nonprofit hospitals may be more likely to cross-subsidize unprofitable services, thereby improving access in their communities. these behavioral indicators not only demonstrate commitment to a purpose far more beneficent than simply the “promotion of health” as proscribed in revenue ruling 69-545,104 they also provide substantial support to justify nonprofit hospitals’ “deservedness” of tax-exempt status. c. mandatory charity care percentages as discussed in part ii, the irs and the tax court have implicitly required something more than the broad dictates of revenue ruling 69-545, something akin to “health care plus” as described by professor colombo.105 moreover, several states have enacted legislation requiring hospitals to provide fixed percentages of charity care.106 while credible arguments exist to support such a requirement,107 this theory of tax-exemption is wrong for a number of reasons. first, an underlying rationale for awarding a hospital tax-exempt status is to relieve the government of a financial burden that would otherwise require the appropriation of public funds.108 this purpose should not presume that free care be the basis of exemption, as community health can be promoted through any number of activities. expressed another way, solely focusing on the amount of charity care provided by a hospital “bears no logical relationship to the needs of a particular community.”109 for example, 103. horwitz, supra note 10, at 159. 104. see rev. rul. 69-545, 1969-2 c.b. 117, available at http://www.irs.gov/pub/irstege/rr69-545.pdf. 105. colombo, supra note 18, at 36-37, 40. 106. see generally ala. code § 40-9-1(2) (lexisnexis 2010) (treatment of charity patients must constitute at least 15% of the hospital’s business); tex. health & safety code ann. § 311.045(b)(1) (west 2010) (a level reasonably related to community needs, an amount equal to one hundred percent (minimum) of the hospital’s tax-exempt benefits, excluding federal income tax, or a combined amount equal to five percent (minimum) of the hospital’s net patient revenue). 107. see gabriel o. aitsebaomo, the nonprofit hospital: a call for new national guidance requiring minimum annual charity care to qualify for federal tax exemption, 26 campbell l. rev. 75 (2004); folkerts, supra note 87; cecilia m. jardon mcgregor, the community benefit standard for non-profit hospitals: which community, and for whose benefit, 23 j. contemp. health l. & pol’y 302 (2007). 108. n. keith emge, jr., nonprofit hospitals and the state tax exemption: an analysis of the issues since utah county v. intermountain health care, inc., 9 va. tax rev. 599, 604 (1990). 109. kevin b. fischer, tax exemption and the health care industry: are the challeng380 indiana health law review [vol. 8:2 suppose hospital a spends $20 million dollars providing free care to indigent patients, and hospital b spends $20 million dollars subsidizing a burn unit and emergency mental health services. while the benefit of free care may be directly observable, assessing the absolute value of cross-subsidized service cannot easily be determined (e.g., hospital b may be located in a community where access to a burn unit or emergency mental health services is compromised due to geographic availability.). second, requiring a fixed amount of charity care may excessively burden smaller or independent hospitals located in rural or lower socioeconomic areas.110 for example, disproportionate share hospitals may already face heightened financial risk given the number of indigent patients they care for.111 were these facilities mandated to provide a larger percentage of charity care, many would struggle further, or perhaps be forced to close.112 by contrast, multi-hospital systems may be able to avoid community benefit disclosure at individual hospitals by reporting community benefit at an aggregate level, which makes it difficult to determine the amount of charity care provided to particular communities,113 and may even conceal lower levels of charity care provided in more affluent settings.114 finally, as the irs exempt organizations (te/ge) hospital compliance project final report illustrates, there is no consistently applied formula used by hospitals to assess their community benefit activities.115 even in states where community benefit reporting has been made mandatory, requirements vary.116 while the new irs form 990 will allow for collection of this information using a standard set of definitions, significant “methodological concerns remain that may influence the analytic value and comparability” of this information.117 specifically, differences in provider type (i.e., size, structure, and scope) and variations in cost accounting methods may have direct implications for assessing the provision of charity care.118 es to tax-exempt status justified?, 49 vand. l. rev. 161, 194 (1996). 110. see kevin m. wood, legislatively-mandated charity care for nonprofit hospitals: does government intervention make any difference?, 20 rev. litig. 709, 736 (2001). 111. disproportionate share hospitals receive adjustment payments from cms based on service to a significantly disproportionate number of low-income patients. see 42 c.f.r. § 412.106 (2010). 112. see stacey kramer, philanthropic pains: the push to implement charity care and community benefit mandates is gaining speed, but will it hurt hospitals?, healthcare informatics, winter 2008, at 66a. 113. jack hanson, access to health care symposium article: are we getting our money’s worth? charity care, community benefits, and tax exemption at nonprofit hospitals, 17 loy. consumer l. rev. 395, 407 (2005). 114. lisa kinney helvin, note: caring for the uninsured: are not-for-profit hospitals doing their share?, 8 yale j. health pol’y l. & ethics 421, 455 (2008). 115. see generally internal revenue serv., supra note 61. 116. salinsky, supra note 55, at 16. 117. id. at 21-22. 118. id. at 22. (criticism also exists regarding filers’ ability to exclude offsetting grant revenues from community benefit calculations; however, this concern is not being addressed, as it does not directly relate to an assessment of charity care.). 2011] hospital tax-exemption and the community benefit standard 381 concerning differences in provider type, the irs identifies filing organizations by employer identification number.119 data will be reported by multi-hospital systems, as well as individual hospitals, which “will make it difficult to compare activities across various provider types and may complicate efforts to analyze schedule h filings in concert with other data sources, such as medicare cost reports and medicaid dsh reporting.”120 while schedule h eliminates the use of charge-based accounting practices in assessing the value of community benefit, filers continue to have flexibility in determining the cost of services (e.g., cost-to-charge ratios, internal cost accounting systems, etc.).121 these differences in costing methods “are likely to yield varying estimates of costs and the validity of some approaches may ultimately be disputed.”122 given the foregoing reasons, and the fact that the irs has historically avoided a mechanical formula for determining whether a nonprofit hospital has met its responsibility under the community benefit standard, it is reasonable to assert that a fixed percentage requirement for charity care could not presently be applied consistently across the industry. d. medicare shortfall, bad debt, and community-building activities 1. the current state of affairs the community benefit standard allows nonprofit hospitals some degree of latitude in determining what services and activities constitute community benefit. as a result, significant variation exists in the type and amount of benefits reported.123 the u.s. government accountability office (“gao”) recently reviewed guidance provided to nonprofit hospitals from five sources, including government agencies (i.e., centers for medicare & medicaid services) and health care industry groups (i.e., the american hospital association, the catholic health association, vha (formerly voluntary hospitals of america), and the healthcare financial management association).124 the gao’s review found that consensus existed among sources to include charity care, the unreimbursed cost of medicaid and other means-tested government programs, and the costs associated with a number of “other activities” (e.g., health professions education, medical research, subsidized health services, etc.) in a definition of community ben 119. id. at 21. 120. id. at 21-22. 121. id. at 22. 122. id. 123. u.s. gov’t accountability office, supra note 2, at 7. 124. id. at 4-5. 382 indiana health law review [vol. 8:2 efit.125 however, debate continues over the inclusion of bad debt, the unreimbursed cost of medicare, and costs associated with “community building activities” (e.g., housing programs, leadership development for community members, workforce development, etc.) in this definition.126 2. bad debt & medicare shortfall bad debt is generally defined as uncollectible patient accounts.127 for example, if a patient’s bill is $5,000, and the hospital only expects to collect $500, the bad debt amount is $4,500. similarly, the unreimbursed cost of medicare, referred to as a “shortfall,” is defined as the difference between a hospital’s cost to care for a medicare beneficiary and the reimbursement received.128 for example, if it costs a hospital $5,000 to care for a medicare patient, yet the diagnosis-related group (“drg”) payment is only $4,500, the shortfall amount is $500. both bad debt and shortfall are shown on hospital financial statements in an amount equal to the charges being written off.129 of the twenty-three states that have enacted mandatory charity care reporting, fifteen allow for reporting of bad debt and/or medicare shortfall.130 regarding bad debt, the catholic healthcare association (“cha”), vha, and the healthcare financial management association (“hfma”) recommend exclusion of this loss in a definition of community benefit.131 cha and vha maintain that “hospitals have the responsibility to better identify patients eligible for charity care, and thus distinguish charity care from bad debt.”132 likewise, hfma encourages hospitals to design charity care policies that provide direction for assessing eligibility when patients provide insufficient information to make a formal determination.133 in contrast, the american hospital association (“aha”) recommends inclusion of bad debt in a definition of community benefit, asserting that low-income patients represent the majority of uncollectible accounts and would qualify for charity care were the appropriate documentation available.134 the irs and the centers for medicare and medicaid services (“cms”) have not tak 125. id. at 7, 29, 49-51. 126. id. at 7, 29, 49. see generally internal revenue serv., dep’t of the treasury, publication 535, cat. no. 15065z, business expenses, (2009), available at http://www.irs.gov/pub/irs-pdf/p535.pdf (providing a comprehensive discussion of business bad debt.). 127. u.s. gov’t accountability office, supra note 2, at 19. 128. id. at 6 n.21. 129. telephone interview with ken j. harbaugh, chief fin. officer, osf saint francis med. center (jan. 4, 2010). 130. salinsky, supra note 55, at 16. 131. u.s. gov’t accountability office, supra note 2, at 20. 132. id. 133. id. at 20-21. 134. id. at 21. 2011] hospital tax-exemption and the community benefit standard 383 en a position on the issue; however, both utilize reporting instruments that permit hospitals to estimate the amount of bad debt attributable to lowincome patients.135 concerning treatment of medicare shortfalls, cha and vha recommend exclusion of shortfall losses in a definition of community benefit, citing concerns over hospital inefficiency, as opposed to underpayment.136 further, because nonprofit and for-profit hospitals compete to attract medicare patients, service to this population is not a differentiating feature.137 by comparison, aha recommends inclusion of shortfall losses in a definition of community benefits citing medicare’s lack of full compensation for hospital costs and the large number of low-income beneficiaries.138 hfma recommends that individual hospitals consider their specific financial status when deciding whether to include shortfall losses in a reporting of community benefit.139 the irs has not taken a position on the issue; however, schedule h requires that hospitals report medicare revenue and cost information separate from traditional community benefit activities, and allows them to explain what portion of these costs they feel should be included as community benefit.140 similarly, cms has not officially taken a position,141 but it does collect information on hospitals’ unreimbursed costs.142 a. bad debt inclusion of bad debt in a definition of community benefit is of great significance to nonprofit hospitals given that many report losses in substantial amounts as compared to charity care.143 based on 2004 data, hospitalspecific bad debt was estimated to be between $26 billion and $30 billion annually, with research suggesting a two to four percent increase in hospitals’ bad debt expense, as a percentage of revenue, by 2012.144 further, it is often impossible to disentangle bad debt from charity care, as more than ninety percent of hospitals state that at least some portion of their bad debt consists of accounts that could be classified as charity care had the patients 135. id. 136. id. at 24. 137. id. 138. id. at 24-25. 139. id. 140. id. at 25. 141. id. 142. internal revenue serv., dep’t of the treasury, omb no. 1545-0047, schedule h (form 990), hospitals (2010), available at http://www.irs.gov/pub/irspdf/f990sh.pdf. 143. u.s. gov’t accountability office, supra note 2, at 23. 144. nick a. lecuyer & shubham singhal, overhauling the us health care payment system, the mckinsey quarterly, june 2007, at 4, available at https://www.tipaaa.com/ pdf/overhauling%20the%20us%20health%20care%20payment%20system-mckinsey% 20report.pdf. 384 indiana health law review [vol. 8:2 been properly identified.145 as such, a compromise position exists whereby a lesser amount of bad debt could be included in a nonprofit hospital’s accounting of charity care. moreover, this inclusion could be made contingent upon the provider’s adoption of systems to better address “administrative inefficiencies.” the following provides two examples of how this lesser amount could be determined, and then considers a number of “payer identification” processes. (i) amount determination. first, bad debt figures could be included in a definition of charity care, calculated as costs rather than charges. not only does the aha advocate this position,146 but also cost information is being requested on schedule h.147 this inclusion would alleviate the potential for bias that exists when using charge data to make comparisons among hospitals, particularly those with different payer mixes.148 for example, comparisons of drgs across hospitals often show “similar costs per case but different markup rates reflected in their charges.”149 a variety of methods have been used to calculate the true “cost” of hospital services, including total medicare allowed charges, medicare payment, and cost-to charge ratios (“ccr”).150 the latter, favored by most researchers, requires an analysis of hospital cost reports and claims data to determine the relationship between medicareallowable costs and hospital charges.151 while all of the aforementioned methods have limitations, research suggests that departmental ccrs are most representative of a hospital’s true cost.152 these costs could be further limited to “variable costs,” as opposed to being calculated on a fully allocated basis, which would include an apportionment of the hospital’s “fixed costs.” variable costs represent those costs that change according to output 145. pricewaterhousecooper’s health research inst., acts of charity: charity care strategies for hospitals in a changing landscape 10 (2005), available at http://pwchealth.com/cgi-local/hregister.cgi?link=reg/charitycare.pdf; see also press release, connance, research indicates one-third of patient bad debt misclassified, should be charity; significant opportunity to demonstrate community benefit (mar. 24, 2009). 146. see am. hosp..ass’n, uncompensated hospital care cost fact sheet 2 (2008), available at www.aha.org/aha/content/2008/pdf/08-uncompensated-care.pdf. 147. internal revenue serv., supra note 59. 148. see generally the lewin group, no. 05-4, a study of hospital charge setting practices, (2005), available at http://www.medpac.gov/documents/dec05_ charge_setting.pdf (discusses the manner in which hospitals establish charges, as well as the relevance of charges given advent of the prospective payment system). 149. bernard friedman et al.,practical options for estimating cost of hospital inpatient stays, 29 j. health care fin. 1, 1-2 (2002). 150. faith m. asper, research data assistance ctr., tn-008, using medicare hospital cost reports cost-to-charge ratios in research 1 (2009), available at http://www.resdac.umn.edu/tools/tbs/tn-008_usingccrsinresearch_508.pdf. 151. id. 152. id. 2011] hospital tax-exemption and the community benefit standard 385 and are saved if the hospital does not provide a service (e.g., medications, disposable supplies, etc.).153 fixed costs represent those costs that do not change according to output, and are not saved if the hospital does not provide a service (e.g., bricks and mortar, equipment, salaried labor costs, etc.).154 this conservative methodology would ensure the highest degree of credibility, as the majority of hospital service costs are fixed.155 second, the taxation and health law sections of the american bar association (“aba”) note that separation of charity care from bad debt is often problematic due to audit guidelines, which may be interpreted to require proof of charity care eligibility that is impractical for hospitals to produce.156 for example, a poor patient presenting in an emergency department is not always in a position to provide income or asset documentation sufficient to determine his or her eligibility for charity care, nor does this patient have incentive to do so after receiving treatment.157 therefore, the aba recommends that the irs consider a flexible standard that allows hospitals to “recognize the amount of charity care they have provided which, after reasonable efforts, cannot be documented with certainty as charity care without unreasonable cost.”158 one such method would be to presumptively include a percentage of bad debt that corresponds to the number of persons within a hospital’s service area that might generally be eligible for free care based on the hospital’s charity care policy.159 (ii) improved processes. initially, nonprofit hospitals could be required to adopt and publish charity care policies in accordance with irs-devised guidelines. while no single “approved” model exists, a number of recommendations have been made both within and without government.160 for example, the senate fi 153. ginevra g. ciavarella et al., distribution of variable vs. fixed costs of hospital care, 281 jama 644, 644 (1999). 154. id. at 646. 155. id. 156. am. bar ass’n section of taxation and health law section, comments concerning discussion draft of redesigned form 990 for tax-exempt organizations, 66-67 (2007), available at http://www.abanet.org/health/04_government_ sub/media/form990_taxexemptorgs_071004.pdf [hereinafter am. bar ass’n]. 157. id. at 67. 158. id. 159. id. 160. see generally staff of s. comm. on fin. minority, supra note 75; p&p board sample 501(c)(3) hospital charity care policy and procedures, healthcare fin. mgmt. ass’n, http://www.hfma.org/templates/interiormaster.aspx?id=240 (last updated dec. 2010) [hereinafter hfma p&p]; healthcare fin. mgmt ass’n, a report from the patient friendly billing project (2005), available at hfma.org/hfmainitiatives/patient-friendly-billing/pfb-2005-uninsured-report/; ill. hosp. ass’n & metro. chi. healthcare council, report of the task force on charity care and collection practices for the uninsured (2003), available at 386 indiana health law review [vol. 8:2 nance committee staff has recommended a minimum eligibility threshold of less than one hundred percent of the federal poverty level, citing the percentage as “a common standard for nonprofit hospitals.”161 in addition, they suggested extensive publication of charity policies, written in plain english and in multiple languages as necessary within a community.162 more recently, hfma published a “model” policy that did not mandate a specific minimum eligibility threshold, but suggested services be made available on a sliding fee scale according to financial need, using federal poverty guidelines.163 the policy further recommended an application process considering patients’ personal and financial information; the use of credit scoring or other publicly available data to determine ability to pay; the use of reasonable efforts to determine alternative public or private funding; consideration of patients’ available assets and other available resources; and review of the patients’ outstanding accounts receivable and payment history.164 a number of other “presumptive financial assistance” criteria (e.g., food stamp eligibility, residence in low income/subsidized housing, etc.) are also recommended when supporting documentation is insufficient.165 next, adoption of hfma principles and practices board statement 15, “which provides instructions for record keeping, valuation, and disclosure of charity care and bad debts on audited financial statements,”166 could allow nonprofit hospitals to better distinguish between charity care and bad debt. board statement 15 exists as a sample policy for presumptively enrolling patients in hospital charity-care programs167 and revised form 990 requests information regarding whether hospitals have adopted the statement.168 this consistency makes it more likely that nonprofit hospitals will begin to adopt the statement as a “best practice” standard for accounting and reporting uncompensated care. finally, hospitals could begin referring to “external sources, such as zip codes in conjunction with per-capita income data, credit reports, and migrant worker status,” in making charity care determinations; a practice that may help estimate the portion of bad debt more accurately attributed to charity care.169 as an example, bjc healthcare recently conducted an extensive analysis of zip code data and found that two-thirds ($85 million) of http://www.nonprofithealthcare.org/resources/charitycare.pdf; cal. healthcare ass’n, key steps checklist for developing or revising a hospital charity care policy (2004), available at http://www.aha.org/aha/content/2004/pdf/chachecklistcharitycare.pdf. 161. staff of s. comm. on fin. minority, supra note 75, at 7 n.11. 162. id. at 6. 163. hfma p&p, supra note 160, at 3, 7. 164. id. at 4. 165. id. 166. salinsky, supra note 55, at 17, 19. 167. melanie evans, making good on bad debt, modern healthcare, january 4, 2010, at 32. 168. internal revenue serv., supra note 59. 169. u.s. gov’t accountability office, supra note 2, at 21 n.53. 2011] hospital tax-exemption and the community benefit standard 387 its $125 million in bad debt was attributed to patients that would have been eligible for charity care under the organization’s existing policy, raising the system’s total community benefit (as a percentage of overall expenses) nearly three percent.170 many facilities are also using screening software, directly integrated with existing information systems, to determine self-pay patients’ eligibility for charity or public funding upon admission or after scheduling.171 features range from eligibility verification and bill estimation, to identification of alterative sources of financial assistance and enhanced third-party payer connectivity. however, these applications can require significant investment in information technology, and may not be realistic options for all facilities.172 b. medicare shortfall. although participation in medicare is voluntary, caring for medicare beneficiaries is a condition for tax-exemption under revenue ruling 69645,173 and very few hospitals can elect not to participate in the public program given the large percentage of care provided to older patients.174 these considerations make clear why inclusion of medicare shortfall in a definition of community benefit is of great importance to nonprofit hospitals. again, a compromise position exists, whereby a lesser amount of medicare shortfall could be included in a nonprofit hospital’s accounting of charity care, expressed as variable and/or fixed costs, rather than charges.175 several practical arguments militate in favor of this position. foremost, medicare was not designed as a complete benefit. beneficiaries are responsible for deductibles, coinsurance, and copayments under “part a” (i.e., inpatient hospital coverage),176 and monthly premiums, annual deductibles, and coinsurance for most services under “part b” (i.e., physician and outpatient coverage).177 as the program has no limit on beneficiaries’ coinsurance responsibility, those with chronic health condi 170. evans, supra note 167, at 32. 171. see healthcare scoring system allows hospitals to increase charity care, l. & health wkly., jan. 2, 2010, at 834; orlando health, saint vincent catholic medical centers, university of maryland medical system and wheaton franciscan healthcare adopt medeanalytics’ patient access intelligence (pai) in 2009, bus. wire, dec. 23, 2009; vha inc names relayhealth a supplier of financial clearance services, hosp. bus. wk., aug. 16, 2009, at 74. 172. telephone interview with ken j. harbaugh, supra note 129. 173. rev. rul. 69-545, 1969-2 c.b. 117, available at http://www.irs.gov/pub/irstege/rr69-545.pdf. 174. am. hosp. ass’n, underpayment by medicare and medicaid fact sheet 1 (2009), available at www.aha.org/aha/content/2009/pdf/09medicunderpayment.pdf. 175. am. hosp. ass’n, supra note 146, at 3 (the american hospital association does not necessarily distinguish between fixed and variable costs.). 176. see 42 u.s.c. § 1395d (2006). 177. see 42 u.s.c. § 1395k (2006). 388 indiana health law review [vol. 8:2 tions or high medical costs can be subject to major cost-sharing expenses.178 given these requirements and limitations on benefits, nearly half of medicare beneficiaries’ health care costs go uncovered.179 this has led the taxation and health law sections of the aba to acknowledge the position that a hospital’s entire medicare shortfall could count as charity care, given the “elderly constitute a clearly-recognized charitable class.”180 moreover, the aha has stated that because many medicare beneficiaries are of limited means, they would likely qualify for a hospital’s charity care program.181 these positions are reinforced by the nearly 8.8 million medicare beneficiaries designated “dual-eligible” for medicaid.182 additionally, medicare payment rates “are set by law rather than through a negotiation process as with private insurers.”183 specifically, the medicare payment advisory commission (“medpac”) makes annual payment update recommendations to congress.184 this update considers both provider-specific factors (e.g., adequacy of current payments, impact of scheduled policy changes, and anticipated changes in provider costs), as well as the “perspective of the economy-wide gains achieved by the firms and workers who pay taxes that fund medicare.”185 while medpac’s use of fixed payments in consideration of the taxpayer’s burden is noble, the inability to negotiate reimbursement rates leaves hospitals ill-equipped to respond to budget deficits brought on by changes in patient demand, staffing, etc.186 between 2000 and 2008, medicare payments also fell significantly relative to costs, and underpayments to hospitals rose from $1.3 billion to $22 billion.187 as a result of this increasing burden, the nationally recog 178. jennifer ryan & nora super, nat’l health pol’y forum, the george wash. univ., nhpf issue brief no. 794, dually eligible for medicare and medicaid: two for one or double jeopardy 4 (2003), available at http://www.nhpf.org/library/issuebriefs/ib794_duals_9-30-03.pdf. 179. id. 180. am. bar ass’n, supra note 156, at 66. 181. erika lunder & edward c. liu, cong. research serv., order code rl34605, tax-exempt section 501(c)(3) hospitals: community benefit standard and schedule h 9 (2008), available at http://assets.opencrs.com/rpts/rl34605_20091110.pdf. 182. teresa coughlin et al., the kaiser family found., where does the burden lie: medicaid and medicare spending for dual eligible beneficiaries 1 (2009), available at http://www.kff.org/medicaid/upload/7895-2.pdf. 183. am. hosp. ass’n, supra note 174, at 1. 184. see hearing on medpac’s annual march report to the congress on medicare payment policy: hearing before the subcommittee on health of the h. comm. on ways and means, 111th cong. 4 (2009) [hereinafter medpac report] (statement of glenn m. hackbarth, chairman of the medicare payment advisory comm’n.) available at http://frwebgate. access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_house_hearings&docid=f:50334.pdf. see generally 42 u.s.c. § 1395b-6 (2006) (providing for the establishment of the medicare payment advisory commission). 185. medpac report, supra note 184, at 4. 186. telephone interview with ken j. harbaugh, supra note 129. 187. am. hosp. ass’n, supra note 174, at 3. 2011] hospital tax-exemption and the community benefit standard 389 nized mayo clinic has implemented a two-year pilot program to assess the financial effect of not accepting medicare patients.188 while medpac asserts that annual reimbursement updates provide enough funding to cover the costs of an efficient provider,189 aggregate medicare margins (payments less costs, expressed as a percentage of payments)190 have reached a tenyear low, dropping from 6.3% in 1999, to -6.9% in 2009.191 in response, medpac states that hospitals facing financial pressure remain able to constrain costs, and that “[o]ver time, aggregate hospital cost growth has moved in parallel with margins on private-payer patients.”192 that being said, medpac’s arguments do not, by themselves, necessitate exclusion of shortfalls in a definition of charity care. finally, cha has suggested that the provision of services to medicare beneficiaries is not a factor that differentiates nonprofit hospitals from their for-profit counterparts; as such, the former should not include medicare losses in a definition of community benefit.193 however, this position ignores two key arguments. first, nonprofit hospitals are required to serve medicare beneficiaries as a condition of tax-exemption,194 whereas forprofit hospitals may elect not to participate in the program.195 second, professor horwitz’s research on managerial behaviors and their impact on access are illustrative of the differences in ownership types; namely, nonprofit hospitals are more likely to provide certain community services regardless of their profitability.196 these motivations should be highlighted and rewarded, despite the fact that for-profit hospitals voluntarily choose to provide services to medicare patients. 188. david olmos, mayo clinic in arizona to stop treating some medicare patients, bloomberg news, dec. 31, 2009, http://www.bloomberg.com/apps/news?pid=20601087& sid=ahoysi84vdl0. see also alec macgillis, mayo clinic faulted for limiting medicare patients, wash. post, oct. 13, 2009, at a04 (noting that the glendale facility will require its 3,000 medicare patients to pay an annual fee of $250, plus $175 to $400 per visit, in order to receive primary care services). 189. medpac report, supra note 184, at 4. 190. medicare payment advisory comm’n, relationships among medicare inpatient, overall medicare and total margins for hospitals 1 (2003). 191. am. hosp. ass’n, american hospital association comments to the senate finance committee on financing comprehensive health care reform: proposed health system savings and revenue options 3-4 (2009), available at http://www.aha.org/aha/testimony/2009/090526-tes-comments-finance-options.pdf. 192. medpac report, supra note 184, at 14. 193. u.s. gov’t accountability office, supra note 2, at 24. 194. rev. rul. 69-545, 1969-2 c.b. 117, available at http://www.irs.gov/pub/irs-tege/rr 69-545.pdf. 195. am. hosp. ass’n, supra note 174, at 1. 196. horwitz, supra note 10, at 173. 390 indiana health law review [vol. 8:2 3. community-building activities although there is a general consensus within the industry to define community-building activities as “community benefit,” the irs has not yet taken a position.197 however schedule h does allow hospitals to report a number of community building activities (physical improvements and housing; economic development; community support; environmental improvements; leadership development and training for community members; coalition building; community health improvement advocacy; and workforce development).198 despite the irs’s need for additional data on the impact of community building activities,199 and suggestions that these activities “represent a relatively small proportion of total operating expenses for hospitals,”200 hospital efforts in this area should not only be included in a definition of community benefit, they should be recognized, rewarded, and encouraged. first, organizations “created to aid low and moderate income families by lessening neighborhood tensions, eliminating prejudice and discrimination, and combating community deterioration may qualify for exemption under section 501(c)(3) of the [internal revenue] code.”201 such organizations might include those formed to develop home construction or renovation programs for sale to low-income families; ameliorate the housing needs of minority groups; or formulate plans to combat neighborhood blight within a particular area in a city.202 given that the aforementioned community building activities are encouraged by the code’s tax-exemption scheme, it seems reasonable to argue that they should be deemed charitable regardless of the providers’ underlying organizational purpose. second, a significant body of research exists demonstrating that social determinants can be responsible for systematic disparities in health across diverse populations.203 social determinants are generally defined as “factors in the social environment that influence health . . . [including] income 197. u.s. gov’t accountability office, supra note 2, at 29. 198. internal revenue serv., supra note 59. 199. u.s. gov’t accountability office, supra note 2, at 29-30. 200. id. at 30. 201. rev. rul. 70-585, 1970-2 c.b. 115, available at http://www.irs.gov/pub/irs-tege/rr 70-585.pdf (alteration in original). 202. rev. rul. 70-585, 1970-2 c.b. 115, available at http://www.irs.gov/pub/irs-tege/rr 70-585.pdf. 203. see generally comm. on assuring the health of the pub. in the 21st, inst. of med., the future of the public’s health in the 21st century (national academy press 2003); comm. on using performance monitoring to improve cmty. health, inst. of med., improving health in the community: a role for performance monitoring (jane s. durch et al., eds., national academy press 1997); comm’n on soc. determinants of health, world health org., closing the gap in a generation: health equity through action on the social determinants of health (2008), available at http://whqlibdoc.who.int/publications/2008/9789241563703_eng.pdf. 2011] hospital tax-exemption and the community benefit standard 391 distribution, discrimination, access to education, and housing policies.”204 more broadly, they represent “the conditions in which people are born, grow, live, work and age . . . .”205 to illustrate the extent of these disparities, there would have been 886,202 fewer deaths in the united states between 1991 and 2000 if african-american and caucasian mortality rates were equalized.206 in contrast, medical advances saved only 176,633 lives during this same period.207 while countless others could be provided, this example is indicative of the notion that traditional interventions alone have not sufficiently addressed the root causes of morbidity and mortality. an emphasis on social determinants of health is not a new phenomenon. in 1974, canada’s minister of national health and welfare suggested that health status could be improved by addressing conditions outside of the traditional health delivery system (i.e., environmental and behavioral threats to health).208 several years later, great britain’s department of health and social security published a report that called attention to persisting health inequalities among britain’s fully insured population.209 the controversial210 “black report” suggested these differences were attributable to social inequalities influencing health, and recommended broad policy measures in response.211 in 2005, the world health organization established a commission on the social determinants of health to collect evidence and to present strategies for the promotion of health equity.212 the commission’s final report, published in 2008, recommended a number of policies to improve living conditions; address the inequitable distribution of power, money and resources; and establish effective measurements to further understand the problem and assess the impact of improvement efforts.213 204. amy j. schulz et al., addressing social determinants of health: communitybased participatory approaches to research and practice, 29 health educ. behav. 287, 288 (2002) (alteration in original). 205. social determinants of health, world health org., http://www.who.int/social_ determinants/en/ (last visited mar. 2, 2011). 206. comm’n on social determinants of health, supra note 203, at 30. 207. id. 208. see generally marc lalonde, minister of nat’l health and welfare, cat. no. h31-1374, a new perspective on the health of canadians (1974) (can.), available at http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/1974-lalonde/lalonde-eng .pdf. 209. see generally sir douglas black et al., the black report (1980), reprinted in inequalities in health, at 29 (peter townsend & nick davidson eds., penguin books, 1992) (1982). 210. see generally caroline richmond, sir douglas black: professor of medicine whose famous report on inequality and health fell foul of the thatcher government, 325 bmj 661 (2002) available at http://www.bmj.com/cgi/content/full/325/7365/661/dc1 (describes the controversy surrounding sir douglas black, principal author of the “black report”). 211. see generally sir douglas black et al., supra note 209. 212. see generally comm’n on social determinants of health, supra note 203. 213. see generally id. 392 indiana health law review [vol. 8:2 in the united states, the department of health and human services (“hhs”) published healthy people 2000, and later healthy people 2010, a national health promotion and disease prevention agenda. the latter’s objectives focus on health determinants that “encompass the combined effects of individual and community physical and social environments and the policies and interventions used to promote health, prevent disease, and ensure access to quality health care.”214 to accomplish these objectives, hhs emphasizes the use of community building activities. specifically, activities aimed at addressing a physical environment may target either tangible (e.g., physical hazards in schools or worksites) or intangible (e.g., radiation, ozone, etc.) problems, while those aimed at addressing a social environment may target interpersonal interactions within the community, interactions with social institutions, and other broad areas such as housing, public transportation, and violence in the community.215 at least one critic has suggested that additional studies are required to determine the exact correlation between mortality and inequality before establishing new policies.216 however, it is impossible to deny the existence of health disparities and the role that social determinants play in their creation and exacerbation. this position is further supported by the attention social determinants have received both nationally and internationally. given the extent to which many nonprofit hospitals are integrated into the social fabric of their communities, they are in a unique position to actively engage in community building. as such, it is reasonable to include costs associated with these labors in a definition of community benefit, despite their generally being considered non-health related charitable activities. iv. maintaining irs control although critics will likely cite the irs’s troubled past, which has been thoroughly documented elsewhere,217 the agency is in the best posi 214. u.s. dep’t of health and human services, healthy people 2010: understanding and improving health 7 (2000), available at http://www.feddesk.com/ freehandbooks/121505-1.pdf 215. id. at 19. 216. see hugh gravelle, how much of the relation between population mortality and unequal distribution of income is a statistical artifact?, 316 brit. med. j. 382 (1998) (arguing that while considerable evidence supports the hypothesis that “holding other factors constant, the higher an individual's income the better is their health,” recent analyses demonstarate that “an individual's health is also affected by the distribution of income within society”). 217. see generally joseph j. thorndike, annual regulation of business focus: reorganization of the internal revenue service: reforming the internal revenue service: a comparative history, 53 admin. l. rev. 717 (2001) (exploring four key periods of irs reform, all revolving around complaints of corruption, favoritism, secrecy, and taxpayer mistreatment); joint comm. on taxation, jcx-44-04, description of present law relating to charitable and other exempt organizations and statistical information regarding growth and oversight of the tax-exempt sector 37-39 2011] hospital tax-exemption and the community benefit standard 393 tion to define a modern community benefit standard. first, the irs has a number of tools to achieve its policymaking objectives. specifically, it may issue: 1) regulations pursuant to congressional directive (i.e., formal rulemaking pursuant to the administrative procedure act); 2) regulations under the irs’s general authority to interpret the code (i.e., informal rulemaking); 3) revenue rulings (i.e., interpretive rules); and 4) private letter rulings applicable only to the requesting party.218 each of the aforementioned stem from different authority, are issued according to different processes, warrant different standards of judicial deference and, as a result, differ in their degree of applicability and binding effect.219 the ability to rely on such an assortment of alternatives allows the irs to quickly and practically adjust to varying situations, as opposed to waiting on the legislature to reform an unwieldy rule. in addition, irs administrators are more likely to have the most sophisticated understanding of complicated tax issues and be in a better position to gather objective information in a less costly manner, as compared to congress.220 for example, the federal advisory committee act (“faca”) requires that nongovernmental entities providing policy advice to an agency be chartered as a federal advisory committee.221 this adds further transparency to agency policymaking, as committees are responsible for holding public meetings, providing advanced public notice of meetings, recording minutes, making documents relied upon in rendering advice publicly available, and making the product of their work publicly available.222 moreover, committees’ membership must be “fairly balanced in terms of the points of view represented” and provisions must be established to assure that recommendations are not inappropriately influenced by any special interest.223 as such, the faca insulates federal “agencies politically by providing an ex (2004), available at http://www.jct.gov/x-44-04.pdf (noting the number of exempt organization returns reviewed declined by approximately 7,000 between 1993 and 2003). but see charities and charitable giving: proposals for reform: hearing before the s. comm. on fin., 109th cong. (2005) (statement of mark w. everson, comm’r. of internal revenue) (noting increased irs resources and improved enforcement efforts targeting tax exempt organizations). 218. bankers life & cas. co. v. united states, 142 f.3d 973, 978 (7th cir. 1998). 219. id. at 978-80. see also ryan c. morris, substantially deferring to revenue rulings after mead, 2005 byu l. rev. 999 (2005) (discussing the internal revenue service’s authority and means to interpret 26 u.s.c.). 220. see generally mark seidenfeld, a civic republican justification for the bureaucratic state, 105 harv. l. rev. 1511, 1515 (1992) (noting that “civic republicanism is consistent with broad delegations of political decisionmaking authority to officials with greater expertise and fewer immediate political pressures than directly elected officials or legislators”). 221. 5 u.s.c.s. appx § 9 (lexisnexis 2011). 222. 5 u.s.c.s. appx § 10(a)-(c) (lexisnexis 2011). 223. 5 u.s.c.s. appx § 5(b)(2)-(3) (lexisnexis 2011). see generally steven p. croley, symposium: public interested regulation, 28 fla. st. u. l. rev. 7, 39-40 (2000) (providing strong evidence for the independent nature of federal advisory committees). 394 indiana health law review [vol. 8:2 ternal, neutral source of expert policy recommendations that can be difficult for legislators and interest groups to ignore or discredit.”224 finally, the flexibility and expertise outlined above is particularly important given legitimate concerns over the quality of schedule h data, especially in early reporting years. while data is expected in late 2010, the need for aggregation may delay its use, and methodological concerns may complicate meaningful comparisons between providers.225 in contrast to the irs, several institutional features make congress “ill-suited to engage in the experimental, adaptive, trial-and-error approach to policymaking”226 that may be required to make effective use of this data as it becomes available. specifically, legislative resources are limited, making continuous monitoring of policymaking difficult.227 moreover, revision of legislative policies can be difficult given the need for a congressional majority, as well as “numerous gate keepers and veto-points.”228 as a safeguard, should congress disapprove of the irs’s policies, it is not without the means to: 1) monitor irs action through oversight, “watch-dog” committees, or formal investigations; 2) express disapproval of irs action by denying or reducing appropriations; or 3) amend the current tax code or enact new legislation.229 v. conclusion given declining reimbursement and increasingly competitive markets, hospitals will continue to report charity care figures in amounts less than the aggregate tax benefit they receive. subsequently, many observers will persist in the belief that these hospitals are not meeting their obligation under § 501(c)(3). however, this perception is oversimplified, as the irs standard for determining hospital tax-exempt status is conditioned upon a community benefit requirement, rather than the provision of free care. while subject to significant criticism by state and federal lawmakers, and arguably subversion by the irs and the tax court, the broad nature of this standard is perhaps its greatest asset. not only are hospitals in the best position to assess the needs of their communities, such a standard is also practical given the manner in which the u.s. health care system is financed. 224. croley, supra note 223, at 38-39. 225. see eileen salinsky, the nat’l health pol’y forum, the george wash. univ., issue brief no. 831, show me the money: the implications of schedule h, 12 (2009), available at http://www.nhpf.org/library/issue-briefs/ib831_showmethemoney_0421-09.pdf. 226. matthew c. stephenson, public regulation of private enforcement: the case for expanding the role of administrative agencies, 91 va. l. rev. 93, 140 (2005). 227. id. at 140. 228. id. at 140-141. 229. matthew bender & company, inc., administrative law § 3.02 (lexisnexis 2010). 2011] hospital tax-exemption and the community benefit standard 395 therefore, in the event that policymakers elect to revise the tax-exemption standard for hospitals, the following considerations are recommended. first, the standard should exclude fixed charity care percentages, as charity care bears no logical relationship to community need. such percentages would have a disproportionate effect on certain facilities, and limited information exists to establish a fair formula for assessing community benefit overall. second, the standard should include bad debt and the unreimbursed cost of medicare, provided hospitals report such figures as variable costs and adopt improved processes to better identify patients eligible for charity care. third, the standard should include and encourage community-building activities, as they are already favored under the code, and they directly address social determinants of health, which is critical to improving population health and addressing growing health disparities. finally, any future revisions of the community benefit standard should be left to the discretion of the irs, given its ability to rely on an assortment of policymaking alternatives, as well as expertise both within and without the agency. despite having ended in mid-2009, the economic recession that began two years ago will likely stifle economic growth over the next several years.230 this economic challenge is not lost on the health care industry, as moody's investors service reports that the nonprofit health care sector outlook remains negative, and that “hospitals face ‘one of the toughest environments in decades’” due to “the federal budget deficit; struggling state budgets; weak employer-sponsored insurance and the nation’s unemployment rate . . . .”231 in addition to this grim economic picture, a recent cms memorandum failed to provide much hope for hospital finances should the current iteration of health care reform legislation, the patient protection and affordable care act (“ppaca”),232 be enacted.233 all of these factors, 230. see cong. budget office, 111th cong., pub. no. 4095, the budget and economic outlook: fiscal years 2010 to 2020, 23 (2010), available at http://www.cbo.gov/ftpdocs/108xx/doc10871/01-26-outlook.pdf. 231. melanie evans, moody’s outlook negative for not-for-profits, modern healthcare (jan. 29, 2010), http://www.modernhealthcare.com/article/20100129/news/ 301299963#. 232. patient protection and affordable care act, h.r. 2590, 111th cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid= f:h3590eas.txt.pdf. 233. memorandum from richard s. foster, chief actuary, centers for medicare and medicaid services, estimated financial effects of the ppaca as passed by the senate on december 24, 2009, 8-9 (jan. 8, 2010) (on file with the centers for medicare and medicaid services), available at http://www.cms.hhs.gov/actuarialstudies/downloads/s_ppaca_ 2010-01-08.pdf (cms’s chief actuary notes that while the act would provide medicaid coverage to an additional thirty-four million uninsured americans, extend solvency of the hospital insurance trust fund an additional ten years, and lower the federal deficit, medicare payment rates would grow slower than provider costs. as a result, “providers for whom medicare constitutes a substantive portion of their business could find it difficult to remain profitable and, absent legislative intervention, might end their participation in the program 396 indiana health law review [vol. 8:2 coupled with significant increases in health care spending projected through 2019,234 suggest that the issue of nonprofit hospital tax-exemption will remain increasingly relevant and be further scrutinized by lawmakers, industry groups, patient advocates, and the media for years to come. vi. addendum on march 23, 2010, president barack obama signed into law the ppaca,235 which along with the health care and education reconciliation act of 2010,236 signed just seven days later, represents the most comprehensive health care legislation in over forty years. though largely “health insurance reform” in that it seeks to improve access and affordability, the ppaca amends section 501(c)(3) to require that nonprofit hospitals: 1) conduct a community health needs assessment every three years; 2) maintain a written financial assistance policy; 3) limit charges for emergency care provided to patients eligible for financial assistance so as not to exceed the amount charged to patients with insurance; and 4) make reasonable efforts to determine whether a patient is eligible for financial assistance before engaging in extraordinary collection actions.237 hospitals failing to comply with the new requirements may be subject to a $50,000 penalty.238 perhaps more notable, the ppaca mandates that the secretary of the treasury and the secretary of hhs “submit to the committees on ways and means, education and labor, and energy and commerce of the house of representatives and to the committees on finance and health, education, labor, and pensions of the senate an annual report” that includes information on all hospitals (i.e., nonprofit, for-profit, and government owned) regarding charity care, bad debt, and the unreimbursed cost of medicaid and medicare.239 the secretaries must also conduct a study on costs associated with nonprofit hospitals’ community benefit activities, and pro (possibly jeopardizing access to care for beneficiaries).” moreover, simulations suggest that approximately twenty percent of inpatient service providers would become unprofitable within ten years due to productivity adjustments.). 234. see generally centers for medicare and medicaid services, department of health and human services, national health expenditure projections 2009-2019 (2009), available at http://www.cms.gov/nationalhealthexpenddata/downloads/proj2009 .pdf. 235. patient protection and affordable care act, pub. law no. 111-148, 124 stat. 119 (2010), available at http://www.gpo.gov:80/fdsys/pkg/plaw-111publ148/pdf/plaw-111 publ148.pdf. 236. health care and education reconciliation act of 2010, pub. law no. 111–152, 124 stat. 1029 (2010), available at http://www.gpo.gov:80/fdsys/pkg/plaw-111publ152/ pdf/plaw-111publ152.pdf (the reconciliation act amended the ppaca to include, among other provisions, an increase in tax credits for individuals to purchase insurance, closure of the medicare part d “donut hole” by 2020, and tax subsidies for low income households.). 237. § 9007, 124 stat. at 855-57. 238. § 4959, 124 stat. at 855-57. 239. id. at 858-59. 2011] hospital tax-exemption and the community benefit standard 397 vide an additional report, no later than 2015.240 clearly, the ppaca demonstrates congress’ concern with community benefit accountability; however, it also reveals a reluctance to approach the issue in an uncompromising manner (i.e., fixed charity care requirements) and a desire to defer to the expertise of the department of treasury and hhs. 240. id. a voiding me avoidable: why state laws need to protect kids from airbags mary ann chirba-martin, j.d., sc.d., m.p.h.* i. introduction ................................................................................... 1 ii. discussion ........................................................................................ 4 a. dimensions of the problem .......................................................... 4 b. efficacy and feasibility of rear seating ...................................... 6 c. legislation as a tool to promote child safety .......................... 10 d. current child passenger laws and strategies: avoidable risks endure ........................................................................................ 12 e. a better approach: using comprehensive child passenger laws to avoid the avoidable ...................................................... 17 f. model child occupant restraint and seating legislation ........ 19 iii. conclusion ......................................................................................... 21 abstract impact with a front passenger airbag engineered to stop a large sta­ tured, adult male from hitting the windshield risks devastating if not fatal harm for a child. "avoiding the avoidable: why state laws need to pro­ tect kids from airbags" proposes a simple solution: absent extenuating cir­ cumstances, require rear seating for child passengers. this article describes the mechanism of injury, examines the inadequacies and inconsistencies of current national and state efforts to reduce pediatric airbag risk, and propos­ es comprehensive "model" legislation to avoid this completely avoidable yet often fatal harm. i. introduction "the airbag that saves your life could kill your child."1 these words form the centerpiece of a consumer education campaign by the u.s. national highway traffic safety administration (''nhtsa") which also cautions: "children and airbags do not mix.'.2 they also crys* j.d. boston college law school. sc.d. and m.p.h. harvard school of public health. contact infonnation: mary ann chirba-martin, boston college law school. 885 center street, newton centre, ma 02459. phone: 617.552.4381. e-mail: chirba­ ma@bc.edu. the author is grateful to john d. graham, ph.d. for his encouragement and generosity, the boston college law school fund for its ongoing support, and jeffrey bears, j.d., for his assistance in preparing this manuscript. 1. national highway traffic safety administration ("nhtsa "), airbag alert, http://www.nhtsa.dot.gov/people/injury/airbag2fmtro/frhelp.htm (last visited x). 2. nhtsa, questions & answers about airbag safety, http:llwww.nhtsa.dot.gov/ peoplf/outteach/safesobr/12qp/airbag.html (last visited apri129, 201 0). 2 indiana health law review [vol. 7:1 tallize a dilemma that has plagued regulators, automotive engineers, and safety professionals since congress' 1990 requirement that all new passen­ ger vehicles, vans, light trucks and cars be equipped with passenger as well as driver airbags by model year 1999.3 in the united states alone, over 138 million or 68% of cars and light trucks have driver airbags and more than 117 million (54.6%) are also equipped with passenger airbags.4 preliminary studies of actual crashes suggest that the passenger airbag has caused a net decline in fatality risk for adult passengers, yet child passengers have experienced a net increase in fatality risk due to the airbag. most of the harm has been incurred by child­ ren under the age of 13 who were unrestrained or were not restrained prop­ erly when a crash occurred. an analysis of data from the u.s. fatality analysis reporting system ("f ars") for calendar years 1989-1998 for children under 13 years of age indicated that front seat passenger side air­ bags pose an increased fatality risk of 31% for restrained children and 84% for unrestrained children.5 nhtsa estimates that absent effective coun­ termeasures, as many as 100 additional children under age 13 will die each year when all passenger vehicles on the road are equipped with dual air­ bags.6 thus, while airbags carry clear protective advantages for adult pas­ sengers, they portend more harm than good for child passengers. a variety of responses are already in the works to mitigate the risks which airbags pose for children. for example, nhtsa has required or is considering, among other things, several design improvements to reduce risks to infants and children. 7 by 1998, some manufacturers had already begun installation of "smart" airbags which temper the force of deployment by as much as 35% based on the size of the occupant needing protection. initial data show a significant reduction in childhood injury,8 but children 3. federal motor vehicle safety standards: occupant crash protection. 62 fed. reg. 807 (proposed jan. 6, 1997) (codified at 49 c.f.r pt. 571). 4. insurance institute for highway safety ("iihs"), highway loss data institute, airbag statistics 2003, http://www.highwaysafety.orglsafety_facts/airbags/stats.htm (last visited april 29, 2010). see also national transportation safety board ("ntsb"), ntsb/ss-96/01, safety study: the performance and use of clllld restraint systems, seat belts and airbags for children in passenger vehicles volume i: analysis (1996), available at http://www.ntsb.gov/publictn/1996/ss9601.pd£ 5. roberta j. glass, maria segui-gomez, john d. graham, child passenger safety: decisions about seating location, airbag exposure, and restraint use, 20 risk analysis 521, 521 (2000). 6. nhtsa, airbag alert, http://www.nhtsa.dot.gov/peoplefmjury/airbag2/intro/ frhelp.htm (last visited x). see also charles j. kahane, nhtsa, dot hs 808 470, fatality reduction by air bags: analyses of accident data through early 1996 (1996) available at http:// www.nhtsa.gov/cars/rules/regrev/evaluate/808470.html. 7. see e.g., 62 fed. reg. 2406, 2406 (proposed nov. 21, 1997) on-off switch); 49 c.f.r. §571, 571 (monitoring performance of advanced airbags). 8. iihs, q &as: airbags, http://www.iihs.orglresearchlqanda!airbags.html (last vi­ sited may 9, 2010). 2010] avoiding the unavoidable 3 still suffer 90% of airbag related fatal and life threatening injuries.9 conse­ quently, despite their initial promise, depowered airbags may actually in­ crease risk-taking through ''moral hazard" whereby more parents allow their children to sit in the front passenger seat in the mistaken belief that depo­ wered batfs have eliminated the risk to children instead of lowering it only slightly.1 . · beyond improving airbag technology, a number of additional solu­ tions also come to mind: (1) do away with passenger airbags and, in doing so, surrender the device's lifesaving gains for adults; (2) redouble efforts to ensure that children are properly restrained in a safety belt and/or car seat, with the front seat moved back outside the airbag's deployment range; (3) allow parents to purchase a switch that can be used to turn off the airbag system when a child is seated in the front seat; (4) encourage or require ve­ hicle manufacturers to install advanced or "smart" airbag systems that do not deploy on the passenger side if a child is seated up front. currently, each of these options is being implemented or at least is receiving serious consideration·by federal regulators and policy makers. 11 this article advocates a more immediate and effective solution: amend state child passenger safety laws to prohibit (with a few exceptions) child­ ren from riding in the front seats of vehicles equipped with passenger air­ bags. simply requiring children to be seated and properly restrained in the vehicle's back seat can reduce the odds of a child being seriously or fatally injured in a crash.12 a handful of states have already ventured in this direc­ tion with some early indications of achieving their intended effect. never­ theless, even those statutes which explicitly address child seating location present numerous opportunities for continued improvement. thus, a "mod­ el" statute is offered, which seeks to maximize child passenger safety re­ garding airbags in particular and collisions in general. although passing legislation inevitably raises political and logistical hurdles, the proposed statute promises substantial improvements in child passenger safety, espe­ cially since it will be easier to enforce than existing seat belt laws. it also builds on educational campaigns already in place which emphasize that the 9. see generally kimberly m. thompson. maria segui-gomez, john d. graham, validating benefit and cost estimates: the case of airbag regulatian, 22 risk analysis 803 (2002). 10. see text, infra note 27. see generally, matthew d. adler, against "individual risk": a sympathetic critique of risk assessment, 153 u. pa. l. rev. 1121 (2005). 11. air bag deactivation, 49 fed. reb. 591 and 595 (proposed aug. 6, 1996). see also nhtsa, fmvss no. 208, final regulatory evaluation: actions to reduce the adverse effects of alrbags: depowering (1997), available at htlp:l/ www.nhtsa.gov/cars/rules/rulings/80gl80g.html; susan a. ferguson, update on airbag perfor­ mance in the united states: beneflls and problems (llhs, arlington, va) 1996; ferguson, s.a. 1996. update on airbag performance in the united states: benefits and problems. air­ bag 2000+: third international symposium on sophisticated car occupantsystems, 7:7-17. karlsruhe, germany: fraunhofer-institut fur chemische technologie (1c1). 12. see nhtsa, supra note 6. see also kahane, supra note 6. 4 indiana health law review [vol. 7:1 rear seat is the safest place for children, and relies on growing public sup­ port for both the existence and enforcement of child seating laws. as such, the proposed statute offers a feasible and effective means to reduce the well proven, substantial in probability, and severe but largely avoidable risk which airbags currently pose to children. ii. discussion a. dimensions of the problem motor vehicle collisions have long been the leading cause of death for children aged 14 and under. 13 in 2007 alone, approximately 5 children were killed and another 548 were injured in motor vehicle crashes each dgy_.14 compounding this tragedy is that many of these casualties could have been prevented by proper restraint use and rear seating, especially in vehicles equipped with front airbags. 15 in its year 2000 putting children first report, the national transportation safety board described the me­ chanism of child airbag injury as follows: airbags can kill or critically injure children in acci­ dents that would have been survivable had the airbag not deployed. the insufficient distance between the restraint system and the inflating airbag, in combina­ tion with the speed and force at which an airbag can inflate, can be lethal to children. a deploying pas­ senger-side airbag strikes the child in the head and neck as opposed to the upper torso where it typically contacts adults. designing and certifying a system to protect all occupants using an average-sized adult male dummy has had tragic results for children.16 in 1991, congress mandated that driver and front passenger airbags be included in all passenger cars manufactured on or after september 1997 and light trucks manufactured within the following year. 17 by 2006, there were 177 million driver airbag-equipped passenger vehicles on the road, with 162 13. center for disease control and prevention ("cdc"), child passenger safety: fact sheet, http://www.cdc.gov/ncipc/factsheets/childpas.htm (last visited may 9, 2010). 14. nhtsa, dot hs 810 987, traffic safety facts: 2007 data: children (2007), available at http://www-nrd.nhtsa.dot.gov/pubs/81 0987.pdf. 15. see cdc, supra note 13. 16. ntsb, ntsb/sr-00/02, puti'ing children first (2002), available at http://www.ntsb.gov/publictn/2000/sr0002.pdf. 17. the intermodel surface transportation act ("istea"), 49 u.s.c. § 30127(b). the intermoda1 surface transportation act ofl991 ("istea"), 102 p.l. 240, 105 stat. 1914 (1991); 49 u.s.c. § 30127(b) (2010). 2010] a voiding the unavoidable 5 million of those containing front passenger airbags, too.18 from 1990 through 2007, airbags saved almost 24,000 lives; the large majority were drivers, but at least 4420 survivors were confirmed to have been riding in the front passenger seat.19 in addition to saving lives, thouf-, airbags can also harm drivers and front passengers, especially children? consequent­ ly, in the same time period of 1990 through 2007, front passenger airbags caused 13 adults to die and another 8 to sustain life-threatening injuries, while hurting a far greater number of children age 12 and under, with 180 confirmed and 9 unconfirmed fatalities, and slife threatening injuries.z1 this particular risk is not surprising given how often children ride in the front seat and travel without proper restraint. in 1997, anywhere from one-third to one-half of american children age 12 and under traveled in the front seat, with the front seating position used more frequently by infants and toddlers than by younger children and pre-teens.22 in 1996, approx­ imately 41% of child passenger fatalities for children age 12 and younger occurred in the front seat.23 by 2006, only 21% of passenger fatalities for this age group occurred in the front passenger location, but that still meant that 209 children died when not properly restrained and seated in the rear as recommended by nhtsa. 24 looking solely at front versus rear seat fatali­ ties without specifically adjusting for airbags reveals that children in the front seat were about 1.5 times more likely to be fatally injured than child­ ren in rear seats. 25 to date, the data have consistently shown that, "[w]hether children are 18. nhtsa, dot hs 810 807, traffic safety facts: 2006 data: occupant protection 5 (2006), available at http://www-nrd.nhtsa.dot.gov/pubs/810807.pdf. 19. nhtsa, special crash investigations: counts of frontal air bag related fatalities and seriously injured persons (2008), available at http://www­ nrd.ohtsa.dot.gov/pubs! abo 1 08.pdf 20. roberta j. glass, maria segui-gomez, john d. graham, airbag exposure and restraint use, 87 am.j. pus. health 1044, 1044-45 (1997) 21. id. at table 1. 22. nhtsa, research note: national occupant protection use sultvey1996 controlled intersection study (1997), available at http://www-nrd.nhtsa.dot.gov/ pubs/97.842.pdf. see also lawrence e. decina & kathleen y. knoebel, child safety misuse patterns in four states, 29 accid. anal. prev. 125 (1997); harry campbell, sheena mac­ donald & paul b. richardson, high levels of incorrect use of car seat belts and child restrains in fife an important and unrecognized road safety issue, 3 inj. prev. 17 (1997); david w. eby, lidiap. kostyniuk, & carl christoff, university of michigan, ann arbor, transportation research institute, umtri-97-36, child restraint device use and misuse in michigan (1997), available at http://www.umtri.umich.edu/library/ pdf71997-36.pdf. 23. nhtsa, dot hs 811 030, traffic safety facts: research note: fatality and in­ jury trends among child front-seat passenger vehicle occupants 12 and younger (2008), available at http://www-nrd.nhtsa.dot.gov/pubsj811030.pdf. 24. id. 25. nhtsa, dot hs 809 784, child passenger fatalities and injuries, based on restraint use, vehicle type, seat posmon, and number of vehicles in the crash 4 (2005), available at http://www-nrd.nhtsa.dot.gov/pubs/809784.pdf. 6 indiana health law review [vol. 7:1 restrained or unrestrained, they are safer when traveling in the second seat ... [although the] relative protection provided by traveling in the second seat (compared to the front passenger seat) is·lessened when the pas­ senger is unrestrained." 26 nevertheless, many children continue to travel in the front and, therefore, remain unnecessarily exposed to the potentially life-threatening risk of an airbag related injury. what is even more alarm­ ing is that a growing number may be doing so with no restraints at all. de­ pending on age subgroup, nhtsa recently estimated that approximately 5 to 10%ofthe country's 61 million children27 still travel in the front passen­ ger seat and that in 2006, 15% of front seated children used no restraint at all. for reasons that have yet to be explained, this figure jumped dramati­ cally to 25% of front seated children perhaps 1.5 million of them being completely unrestrained in 2007.28 b. efficacy and feasibility of rear seating a shortage of seating capacity in the rear does not explain why amer­ ican children frequently ride in front. in a study of 17,000 fatal crashes from 1985 through 1996, in which a child (dead or surviving) was seated in the front, the rear seat was completely empty in 65% of the cases and at least one rear seat was unused in 96% of cases. 29 in continental europe, law and custom have cultivated markedly different seating patterns among children since at least the mid-1970's. an observational survey comparing child seating behaviors in three european cities (frankfurt, germany; paris, france; brussels, belgium) to behaviors in two america cities (boston, massachusetts; new orleans, louisiana) found that children in america were three times more likely than european children to ride in the front seat.30 even within the united states, child seating patterns appear to vary 26. id. at 51. see also roberta j. glass & john d. graham, kids at risk: where amer­ ican children sit in passenger vehicles, 30 j. safety res. 1 7 (1999); elisa r. braver, randy whitfield & susan a. ferguson, seating positions and children's risk of dying in motor vehicle crashes, 4 inj. prev. 181 (1998); kahane, supra note 6. 27. see nhtsa, traffic safety facts 2007 data: children, supra note 13 at i (esti­ mating the u.s. population of children age 14 and younger to be 61 million. that between 5 and 10% of these children ride in the front seat is based on data reported in nhtsa traffic safety facts: child restraint use in 2007overall results). 28. nhtsa, trqffic safety facts: child restraint use in 2007-overall results 2 (2008), http://www.nhtsa.dot.gov/portavsite'nhtsa/menuitem.6a6eaf83ct719ad24ec86e 1 odba046a0/. 29. roberta j. glass, & john d. graham, kids at risk: where american children sit in passenger vehicles, 30 j. safety res. 17-24 (1999); donald f. huelke & charles p. compton, the effects of seat belts on lrifury severity of front and rear seat occupants in the same frontal crash, 27 accid. anal. prev. 835-838 (1995). 30. maria segui-gomez, roberta j. glass, john d. graham, where children sit in motor vehicles: a comparison of selected european and american cities, 4 inj. prev.98-102 (1998); maryvonne dejeames, claes tingvall, ake nygren, effectiveness of safety belt use laws: a multinational examination, u.s. dept. of transportation (1986), available at· http://www.eric.ed.gov/ericdocs/data/ericdocs2sql!content_storage _ 2010] avoiding the unavoidable 7 by state with some states having twice as many children in the front seat as others.31 for example, a 2005 study of observed seat belt use measured a low of 49.6% in new hampshire to a high of95.2% in the state ofwash­ ington.32 in the united states, numerous public education programs designed to encourage adults to seat children in the back of passenger vehicles have been underway for several years. nhtsa has incorporated information about seating location (with varying degrees of emphasis) into its "cam­ paigj) safe and sober" and its "child transportation safety tips" litera­ ture.33 the insurance institute for highway safety's (iihs) kids and airbags c~aign is another effort to influence seating behavior through education. 34 a number of states launched kids in back promotions such as that of massachusetts in may 1998, but they varied widely in content and duration. some of the tag lines sought to be clever (such as nhtsa's sug­ gested "for safety's sake ... the back seat is the best seat") while other messages were far more blunt (''the airbag that saves your life could kill your child," again offered by nhtsa). consumer education efforts have not consistently integrated seating position with seat belt usage. instead, they have tended to discuss either seat belts or seat position, but not both at least not on an enduring basis. for instance, the 1996 "presidential initiative for increasing seat belt use nationwide" called for state laws to effectuate ••comprehensive child pas­ senger safety" but made no mention of seating location. 35 perhaps this oversight can be explained by a lack of data in 1996 to link front seating with airbag-related injuries.36 however, the national safety council's web description of its air bag and seat belt safety campaign's national "click it or ticket mobilization" continues to say nothing about airbags or rear • 37 seating. oi/0000019b/80/1c/2b/1d.pdf. ; improper use of child sqfety seats, kentucky 1996, 47 morbidity & mortality wkly. rep. 541-44 (1998), available at :ftp://ftp.cdc.gov/pub/ publications/mmwr/wk/ mm4726.pdf (last visited apr. 17, 201 0). 31. id see glass, gomez & graham, supra note 19, at table 1; maria segui-gomez, et al., where children sit in cars: the impact of rhode island's new legislation, 91 am. j. pub. healm 311 (2001). 32. nhtsa, how states achieve high seat belt use rates table 31 (2008). 33. nhtsa, campaign safe & sober, http://www.nhtsa.dot.gov/peoplel out­ reach/safesobr/; nhtsa, child transportation safety tips, tip #9 airbag safety, www.nhtsa.gov/peoplelinjury/childps/newtips/. see also llhs-hlds, kids & airbags, www.highwaysafety.org/safety-facts/airbagslkids-airbagslkids-airbags.htm. 34. iihs, kids & airbags, http://www.iihs.orglresearch/topics/airbags.html. in con­ trast, the 1996 mayo health program's airbags and infant car seats: they don't mu: cam­ paign is no longer available on its website. 35. presidential initiative for increasing seat belt use nationwide, http://www.nhtsa.dot.gov/peoplelinjury/airbags/archive-04/presbelt/fullreport.html (last visited apr. 17, 2010). 36. id. 37. nhtsa, click it or ticket, hup:/lwww.nhtsa.govlportal/site/nhtsa/menuitem. ce4a601cdfe97fc239d17l1 ocba046aoi (2009). 8 indiana health law review [vol. 7:1 a detailed example of the relative de-emphasis of seating location can be found in the national safe kids campaign's february 2001 grading of state child restraint laws. 38 it assigned a grade of "f' to 24 states, "d" to 18 states plus the district of columbia, "c" to 5 states, and only one "b" (to florida) and "a" (to california).39 however, the seven criteria on which scoring were based took no express account of seating location.40 thus, while the organization supports rear seating mandates, it focuses exclusive­ ly on proper restraints for various age groups and says nothing about seat­ ing location on its introducto~ webpage.41 despite recent enhancements to such educational initiatives, these messages must be consistently and tightly integrated, both because they are necessary complements of one another in reducing crash-related injuries and because integration will max­ imize efficient communication to the target audience. automotive manufacturers have a particularly acute interest in reduc­ ing airbag injuries for all age groups since they are required by federal law to install passenger airbags but face liability exposure if an airbag causes injury.43 thus, car makers can rightfully view airbags as an enduring catch-22. prior to federally mandated airbag installation, many product liabiliw suits asserted manufacturer liability for the failure to install air­ bags.4 once installed, airbags engendered a new generation of product defect claims based on equipment malfunction (i.e., failure to deploy or in­ appropriate deployment in a collision) as well as claims regarding the sjm?­ cial hazards which airbags pose for children and small-statured adults.45 consequently, automakers, insurers, and airbag suppliers made their own efforts to incorporate the ''kids in back" message into their advertising cam­ paigns. these efforts began in 1996 when the national safety council, nhtsa, and the national transportation safety board collectively hosted a national "call to action" conference to encourage public and private enti­ ties to focus on reducing child airbag injuries.46 as data accumulated, the 38. see national safe kids campaign, child passengers at risk in america: a national rating of child occupant protection laws (2001), http://www.usa.safekids. org/content_documents/acf15f4.pdf. 39. id. at5. 40. jd.at4. 41. national safe kids campaign, child passenger safety, http://www.usa.safekids. org/skbulcps/index.html. 42. e.g., nat'l safety council, air bag and seat belt safety campaign "operations abs", http://www.nsc.org/airbag.aspx 43. see cynthia m. certo, changes to safety standard 208: deploying an (air) bag full of product liability claims? 61 temp. l. rev. 673 (1994). 44. see, e.g., timothy wilton, federalism issues in "no airbag" tort claims: preemptionandreciprocalcomity,61 notredamel.rev.l (1986). 45. see, e.g., thompson, supra note 8; nhta, traffu: safety facts 2007 data: child­ ren, supranote 13. 46. see, e.g., jim hall, chairman, natl. transportation safety board, nhtsa/ nation­ al safety council conference, safety belts, airbags & passenger safety: a call to action (jan. 16, 1996) http://www.ntsb.gov/speeches/formerlhal1/jh960116.htm. 2010] a voiding tile unavoidable 9 spring of 1998 saw a coordinated national media blitz by law enforcement organizations, automotive manufacturers and suppliers to promote the dual messages of "buckle up" and "kids in back.',47 the u.s. airbag coalition, managed by the u.s. national safety council, played an early role in coor­ dinating educational efforts in the public and private sectors.48 nhtsa's multi-year buckle up america initiative built on this consolidated and coordinated approach by encouraging partnerships among government, in­ dustry, and consumer groups to enhance data collection and improve the availability and quality of information.49 the growth in law enforcement interest was particularly dramatic, with 1000 agencies becoming involved by 1997, eventually growing to over 12,000 by 2002.50 such public information campaigns should be commended for focus­ ing public attention on airbags and child safety. these campaigns have un­ doubtedly contributed to yearly reductions in airbag related child fatalities. 51 they are also an essential tool in dispelling misconceptions about the need to use proper restraints and the safety advantages of the rear seat. by themselves, however, information and educational campaigns should not be expected to achieve adequate and lasting changes in how children are seated in vehicles. indeed, a 2005 national safety council sponsored report showed that front seat deaths for children increased prior to 1995, but declined by 67% from 1996 through 2003. 52 these gains were primarily attributed to the effectiveness of using public education and law to promote rear seating, as opposed to making front travel safer because of side or depowered frontal airbags. 53 accordingly, as important as technol­ ogical improvements are, public safety campaigns and legislative enactment and enforcement must be viewed as far more immediate and effective tools for reducing front seat injuries. thus, a more successful behavioral intervention in the safety field usually entails augmenting often inconsistent public safety campaigns with 47. see, e.g., maria segui-gomez, evaluating interventions that promote the use of rear seats for children, 16 am. j.preventivemeo. 23 (1998). 48. u.s. national safety council air bag seat belt sqfety campaign, hitp:/lwww.nsc. ollifparlnerslairaboutaspx. 49. u.s. dept. of transportation buckle up america initiative, hitp:/lwww.nhtsa.dot gov/people/outreacb/safedigelsummerl999/su9950.htm. 50. james l. nichols, donna glassbrenner, & richard p. compton, the impact of a nationwide effort to reduce airbag-re/ated deaths among children: an examination of fatality trends among younger and older age groups, 36 j. safety res. 309 (2005). 51. nhtsa, counts of frontal airbag related fatalities and seriously injured per­ sons, available at http://www.nrd.nhtsa.dot.gov/pubs/ab0108.pdf (hereinafter ''nhtsa, counts") ; stephanie zaza, et al., reviews of evidence regarding interventions to increase use of child safety seats, 21 am. j. of preventive med. 31 (2001). see also sullivan v. ford motor co., 2000 u.s. dist. lexis 4114 (s.d. n.y. 2000); wheelerv. chrysler corp., 2000 u.s. dist. lexis 2725 (n.d. ill. feb. 29, 2000). 52. see nichols, supra note 49, at 318. 53. id. see also http://www-md.nhtsa.dot.govlpdf7md-01/safjsae2003/kindelberger_ kid.pdf. 10 indiana heai..m law review [vol. 7:1 an enduring legal requirement accompanied by intensive and visible police enforcement. again, experiences in both continental europe and the states bear this out. 54 without the deterrent and· moral force of a·tegal require­ ment, it is difficult for education alone to convert attitudinal changes into lasting improvements in risk-reducing behaviors. the need for a legal re­ quirement will become even more apparent in the years ahead as vehicles with passenger airbags are resold in the used car market to owners who may be less aware of important safety concerns. 55 if laws about child seating behaviors do not change, it may become more difficult for auto makers and advocates to justify continued investments in education and information. c. legislation as a tool to promote child safoty rear seating has consistently been shown to reduce a child's risk of injury whether or not a passenger-side airbag is present, and legal mandates have just as . consistently proved to be most effective in altering restrai~t use. 5 therefore, a statutory rear-seating requirement would seem to be an obvious and valuable way of decreasing child airbag injuries. nevertheless, it is important to recognize that such measures are likely to ·encounter a sig­ nific8nt degree of generalized opposition to government intrusion into the parent-child relationship.57 as a result, opponents may characterize legal directives to parents concerning where and how to seat their child in the privacy of their own car as government patriarchy at its most overreaching. while any legislative proposal will encounter resistance, child safety advocates and state legislators are on especially firm ground in acting to improve child safety through mandatory rear seating. federal regulations,. along with state product liability and "lemon" laws already create a strong, if not pervasive presence in the field of automotive safety. 58 plus, through its parens patriae power, the state has a special obligation to protect the health and saf~ of children even if it means occasionally overriding paren­ tal decisions.59 parens patriae authority permits a state to act in place of 54. see nhtsa, child fatalities, supra note 24. 55. see national safe kids campaign, child passengers at rjsk in america, su­ pra note 38 and accompanying text 56. maria segui-gomez et al., where children sit in cars: the impact of rhode isl­ and's new legislation, 91 am. j. pub. healm 311 (2001). 57. see generally gregory thomas, the parent/child relationship: limitations on parens patriae: the state and the parent/child relationship, 16 j. contemp.·legal issues 51 (2007). · 58. see, e.g., kurt b. caldwell, automobile passive restraint claims post-cipollone: an end to the federal preemption defense, 46 baylor l. rev. 141 (1994); kevin m. mcdonald. federal preemption of automotive recalls: a case of too many backseat driv­ ers?, 71 tenn. l. rev. 471 (2004). literally thousands of federal motor vehicle safety stan­ dards are contained in 49 c.f .r. 571. 59. &e thompson, supra note 8; nhta, traffic safety facts 1007 data: children, supra note 13. 2010] avoiding the unavoidable 11 the parent when either 1) the parent proves to be unfit to act on his child's behalf, or 2) the state essentially decides that there is only one "right an­ swer" since any other· choice would place the child at a risk of harm which the state, through its courts or legislators, has deemed intolerable.~ the exercise of parens patriae authority underlies the requirement that children must attend school and receive certain vaccines as a condition of attending public school. even parents who wish to "home school" their children must comply with state standards. in extreme cases of parental abuse or neglec4 the state will go so far as to remove the child from the family with formal custody vested in the state. numerous judicial decisions have invoked pa­ rens patriae power in requiring a child to receive blood transfusions or oth­ er life saving medical treatment over parental objections. as the united states supreme court explained over 50 years ago in prince v. massachu­ setts: parents may be free to become martyrs themselves. but it does not follow that they are free, in identical circumstances, to make martyrs of their children be­ fore they have reached the age of full and legal discre­ tion when they can make that choice for themselves.61 · in the context of motor vehicle safety, a legislative or regulatory entity essentially decides that only behavior which comports with the government mandate sufficiently protects the child's best interests. as .such, it becomes the only available legal option and, therefore, trumps a parent's right to make a different choice for the child. in the context of children ·and airbags, law makers can rely on the prince v. massachusetts rationale to require rear seating because parents should not be free to expose their children to legally proscribed risks even if they might decide otherwise for themselves. nev­ ertheless, some risks may be too slight or unsubstantiated (e.g., rear center vs. rear outboard seating of children) or too enmeshed in . complex child-rearing issues (e.g., a child's dietary patterns) to justify state interven­ tion. however where, as here, the risk to children is well-proven, substan­ tial in both probability and severity, easily preventable, and affected by 60. typically, the state steps in and renders a decision using either the "best interests" or "substituted judgment" standard. under the best interests analysis, the state simply eva­ luates which option is most commensurate with the child's objective best interests. the subs­ tituted judgment test requires the state to assess how the child, a legal incompetent, would decide if she were competent. fortunately, at the policy level, it is possible to avoid the logi­ cal complexities of the substituted judgment test. in enacting child-protective legislation or promulgating regulations under such laws, the best interests implicitly guide deci.o sion-making. 61. 321 u.s. 158, 170 (1944). see also santosky v. kramer, 455 u.s. 745~ 766 (1982) (acknowledging a state's "parens patriae interest in preserving and promoting the welfare of the child"). 12 indiana health law review [vol. 7:1 extensive laws and regulations already "on the books," the case for state intervention into parental choice is compelling. in this context, policy need not rest solely on data. rather, longstanding legal and political precepts require well-designed and consistently enforced laws to reduce child airbag­ related injuries and fatalities. d. current child passenger laws and strategies: avoidable risks endure given the special role of government in protecting children, and fed­ eral funding incentives to do so in the context of motor vehicle safety, it is not surprising that every state has enacted some form of child passenger legislation. yet, none of these statutes adequately protect child passengers since all contain at least one and usually more of seven deadly gaps in state child seating laws. first, state laws vary in the age of the child required to be restrained (without regard to seating location), but most only cover children aged 7 and under. this approach obviously leaves a substantial population of children completely unprotected by such laws.62 second, the conseguences for non-compliance tend to be sligh~ with small financial penalties63 and no duty to report violations to insurers. 4 failure to use seat belts is commonly inadmissible in litigation, particularlr as evidence of contributory or com­ parative negligence or recklessness.6 third, state laws often apply only to vehicles registered in that state, further curtailing their effectiveness. 66 fourth, many child restraint laws are vague in only requiring "proper" re­ straint without defining how that term is to.be interpreted or enforced.67 a number of states do require the meaning of "proper" to be determined by reference to federal safety standards.68 as discussed below, linking state law to federal safety standards is an important step in building more effec­ tive child passenger safety laws since it permits state protections to evolve as the science of motor vehicle safety improves. fifth, because the large majority of state child occupant laws focus on 62. e.g., ala. code§ 32-5-222{a) (2009); cal. veh. code§ 27315(e) (2009); va .. code ann.§ 46.2-l095(a) (2009). 63. e.g., tenn. code. ann. § 55-9-602 (2009) ($50); mo. rev. stat. § 307.179 (2009) ($50 plus court costs). 64. typically, events are not reportable if they do not involve personal injury or prop­ erty damage of some significant dollar amount. see, e.g., susan a. ferguson, donald w. reinfurt &allan f. williams, survey of passenger and driver attitudes in airbag deploy­ ment crashes, 28 j. safety res. 55 (1997). 65. e.g., r.i. gen. laws § 31-22-22 (2009). 66. e.g., haw. rev. stat.§ 291-11.5 (2009). see also, nhtsa, summary of vehicle occupant protection laws, http://www.nhtsa.dotgov/ peoplelinjury/airbags/v ehoccprotectionlaws.pdf. 67. e.g., haw. rev. stat. § 291-11.5 (2009); cal. veh. code§ 27360.5(a) (2009); mass. gen. laws ch. 90, § 7aa.(2009) 68. e.g., la. rev. stat. ann. § 32:295 (2009); ariz. rev. stat. ann. § 28-907 (2009). 2010] a voiding 1lie unavoidable 13 seat belts without reference to rear or back seating, they are difficult to en­ force.69 a law enforcement officer standing outside of a car especially if some distance away from it -may not notice the absence or improper use of a seat belt if the child is sitting still. "improper" belting or restraint is even more difficult to detect through observation alone, unlike the more obvious location of the child in a vehicle. consequently, seating location mandates would be much easier to enforce. a sixth major disadvantage of many state seat belt laws is that they impede enforcement by simply de­ scribing seating requirements without specifically charging the driver with ensuring compliance?0 seventh, and finally, a sizeable number of states continue to employ "secondary'' as opposed to "primary" enforcement. "primary" enforcement allows a police officer to stop and issue a citation upon observation of an unbelted occupant while "secondary" enforcement, the more common of the two7 permits a citation only if the car has been stopped for another infraction. 1 failure to wear a seat belt is not, in and of itself, a sufficient ground to stop a car and write a ticket in second­ ary-enforcement jurisdictions. primarily enforceable seat belt laws clearly work, and a growing num­ ber of states are converting from secondary to primary enforcement, rising from 18 before 2004 to 25 (plus the district of columbia and puerto rico) as of2006.72 the most impressive gains in both adult and child belt usage have been realized in those states which have moved toward aggressive prim~ enforcement of their seat belt laws in conjunction with media edu­ cation. 3 a typical example is the state of washington which experienced a 13.9% reduction in overall motor vehicle occu~t fatalities following its passage of a primarily enforceable seat belt law.74 nhtsa reports that in 2008, 88% of motor vehicle occupants used seat belts in primary law states 69. e.g., ark. code ann.§ 27-34-104 (2009); nev. rev. stat.§ 484.474 {2009); 75 pa. cons. stat. § 4581 (2009). 70. e.g., or. rev. stat. § 811.210 (2009). compare cerun liuet, et al., nhtsa, trqfftc safety facts research note: states with primary enforcement laws have lower fatality rates (2006), available at http://www-md.nhtsa.dot.gov/pubs/810557.pdf with nhtsa, trqfftc safety facts research note:states w'uh primary enforcement laws have lower fatality rates (updated) (2008), available at http://www­ md.nhtsa.dotgov/pubs/81092l.pdf. 71. id. and accompanying text 72. natl. safety council, operation abc mobilization: encouraging trends in strengthening safety laws (revised 2002), http:/lwww.nsc.org/partners/encourge.aspx. 73. see nhtsa, presidential initiative for increasing seat belt use nationwide, http://www.nhtsa.dot.gov/peop1e/injury/airbags/archive-041presbeltfmdex.html. 74. see generally, nhtsa, primary enforcement saves lives: the case for upgrading secondary safety belt laws, htlp://www.nhtsa.dot.gov/ people/injury/enforce/ primaryenforcement/images/primaryenforcementpdf; nhtsa, tra.fftc safety facts: strengthening safety belt use laws-increase belt use, decrease crash fatalities and injuries, http://www.nhtsa.dotgov/peoplelinjury/new-fact-sheet03/seat beltlaws.pdf(2004). 14 indiana health law review [vol. 7:1 while only 75% did so in secondary law states.75 the difference is espe­ cially significant when it comes to children since child restraint use increas;. es with· adult use even without specifically amending the child restraint law.'6 nevertheless, while child safety seat laws are primarily enforceable in all states, only half of all states permit primary enforcement of their seat belt laws. as a result, in half of all states, children who no longer use car seats are deprived of the benefits of primary enforcement.77 . ·improving a state's general seat belt laws can improve the safety of child passengers and should have some impact on frontal airbag injuries, but it cannot compensate for existing weaknesses in the child passenger laws themselves. in terms of reducing frontal airbag injuries to children, the central problem with the large majority of state child passenger safety laws is their failure to make any mention of rear seating for children. to date, only fourteen state laws express some form of preference or limited requirement for rear seating; however, to varying degrees, even these meas­ ures leave most children exposed to frontal airbag injury.'8 for instance, california and georgia require use of available rear seating without regard to frontal airbag activation, but only for children five years and younger, leaving older but equally vulnerable children at risk. 79 vermont only re­ quires rear seating for children 1 year or younger or under 20 pounds unless the front airbag is deactivated. 80 in contrast, louisiana and idaho have no rear seating requirement although they permit but do not require seating children, aged 18 months to under 4 or 5 years, in the rear with a seat belit as an alternative to using a child car seat in the front passenger location. 8 clearly, these provisions are not designed to address the safe adult/endangered child dilemma of airbags. in july 1997, rhode island took the lead in using law to reduce child airbag injuries when it revised its child restraint law to require rear seating, initially for children through age 5 and now age 7 (improving upon an earli­ er bill's. use of an age 3 cut-oft). 82 front seating, with a seat belt or safety seat; is permitted for such children if the vehicle has no rear seat or if all rear seats are occupied by other children. an observational study conducted in the year following enactment of the rhode island statute indicated that 75. nhtsa, traffic safety facts research note: seat belt use in 2008overall results 1 (2008), http://www-nrd.nhtsa.dot.gov/ pubs/811036.pdf. 76. see, e.g., julie russell, marcie-jo kresnow, robert brackbill, the effect of adult belt laws and other factors on restraint use for children under age 11,26 accid. anal. & prey. 287 (1993). 77. see caldwell, supra note 57, mcdonald, supra note 57 and accompanying text. 78. iihs, child restraint laws, http://www.iihs.org/laws/childrestraint.aspx 79. cal. veh. code §27360(a) (2007); ga. code ann. §40-8-76(bxl)(b) (2009). 80. vt. stat. ann. tit. 23, §1258(a)(l) (2009). 81. idaho code ann. § 49-672 (2009); la. rev. stat. ann. § 32-295 (2009). 82. see supra note 51. see also r.i. gen. laws §31.22.22(ax1x2000),1daho code ann.§ 49-672 (2001); la. rev. stat. ann.§ 32:295. 2010] a voiding the unavoidable 15 the law was achieving significant gains in increasing rear seating. 83 while laudable as an early effort at rear seating legislation, the rhode island sta­ tute is too ·limited, most notably because it does not protect children older than 7. unfortunately, when north carolina amended its child restraint sta­ tute in 1999, it followed rhode island's initial approach of restricting its rear seating mandate to children less than 5 years of age of 40 ~ounds in weight.84 new mexico and south carolina followed suit in 2001. 5 delaware took a somewhat better approach when, in 1998, it enacted a statute requiring any child under 12 years of age and less than 65 inches in height to be seated in the rear of vehicles equipped with front passen­ ger-side airbags.86 the front seat prohibition does not apply, however, if the airbag has been deliberately rendered inoperable or bas been "specifical­ ly designed or modified by the vehicle's manufacturer for use by children and small adults."87 the delaware law obviously improves upon its rhode island predecessor by protecting a broader age ran~e of children and the state of washington bas taken a similar approach. nevertheless, while delaware bas so far formulated the best legislative response to the special dangers which airbags create for children, it also fails to optimize child safety. its most obvious shortcoming is that, initially, it only imposed a maximum fine of just $28.75 per offense. while this has since been in­ creased to $75, it is still quite modest given that an offense is based on the event of being cited rather than the number of improperly seated children per event. more significantly, the statute applies solely to vehicles with functional front passenger airbags and, thus, does nothing to diminish the dangers to front seated children in vehicles without airbags. 89 a more troubling aspect of the delaware law is its strategy for keep­ ing pace with technological innovation. statutes should be designed to evolve over time. this law, however, permits front seating if the airbag is "specifically designed or modified by the vehicle's manufacturer for use by children and small adults." when first passed, the law was scheduled to "sunset" or lose effect on january 1, 2003 "provided new federal regula­ tions regarding safer deployment of airbags are in effect."90 "safer" is a relative term which is only further clouded by the statute's vague use of "regarding." the statute's framers seemed to assume that any design mod­ ifications or new federal regulations which somehow "regard" "safer" air­ bag deployment will, without more, necessarily reduce airbag child 83. maria segui-gomez, et al, where children sit in cars: the impact of rhode island's new legislation, 91 am. j. pub. health 311,311 (2001). 84. n.c. gen. stat.§ 20-137.1(2000). 85. n.m. state§ 66-7-369b (2001); s.c. code ann.§ 65(1). 86. del. code ann. title 21, § 4803 (2004). 87. /d. 88. wash. rev. code§ 46.61.687 (2001). 89. del. code ann. title 21, § 4803 (2004). 90. /d. 16 indiana heal til law review [vol. 7:1 passenger risks to some tolerable level new or amended federal safety standards may indeed abate airbag-induced risks to child passengers. such changes, however, will not necessarily erase such risks nor will they negate the overall benefits of seating children in the rear instead of the front of a car. fortunately9 the statute was reauthorized and currently contains no sunset provision. 1 indeed, if the experience with airbags to date has taught policy makers anything, it should be that new technology and/or federal requirements can reduce some risks while unintentionally creating new ones. thus, legislators must be wary of designing a statute to recede auto­ matically upon future safety "improvements." europe's experience with seating location mandates is also instructive. between 1975 and the early 1990's, most countries in continental europe required children to ride in the rear seats. the age cut-off was 12 in ger­ many; and 10 in france and belgium. at the suggestion of the european commission, these laws were gradually liberalized in the 1990's to permit children in the front if they are restrained properly.92 the liberalization occurred prior to the introduction of passenger airbags, which are penetrat­ ing the european market slowly due to the absence of regulation and the high rates of safety belt users. the european commission may be forced to revisit this issue as the passenger airbag becomes more prevalent. thus, existing child passenger safety laws in the united states are not well designed to protect children from passenger airbags. nhtsa has ad­ vocated for improvements to state laws, but has not highlighted the benefits of rear seating mandates.93 yet, legislative change (be it a major overhaul or incremental fine tuning) should require rear seating as a far simpler ap­ proach than the current reliance on ''proper" restraint if only because it is so much easier for a police officer to observe seating position than it is to detect improper restraint use. because rear seating requirements are neces­ sary to reduce fatality and injury rates associated with front airbags, they must not be overlooked or separated from other legislative and educational efforts to increase seat belt use. several strategies have already emerged to remediate the previously described deficits in state laws. they include: 1) repeal the passenger air­ bag requirement; 2) promote proper restraint use by children in the front and/or rear seat; 3) allow parents to purchase an airbag cut-off switch for the passenger airbag; and 4) encourage or require advanced airbag designs that protect children. while laudable in their objectives, these strategies are as flawed as the laws they seek to improve. repealing the passenger airbag requirement would be an overreaction since the technology appears to be saving a significant number of adult 91. !d. 92. id 93. see supra note 40. 2010] avoiding the unavoidable 17 lives in a cost-effective manner. even if the airbag requirement were re­ pealed, a case for child seating laws could still be made for the many mil­ lions of airbag-equipped vehicles already in use and the future vehicles that manufacturers would· elect to equip with passenger airbags as optional or standard equipment. concerted efforts to promote proper restraint use among children are urgently needed but, as already explained, focusing solely on restraint while deemphasizing or ignoring seating location misses important gains in improving child passenger safety. moreover, it would still be easier for police to enforce child restraint-use laws if they could stop any vehicle with a child located in the front seat. for these reasons, a com­ bination of primary enforcement of child-seating and child-restraint laws is the most promising behavioral strategy. nhtsa has permitted vehicle owners in eligible categories to pur­ chase manual cut-off switches to deactivate an airbag when a child is riding in front. since january 1998, dealers and repair shops can install on-off switches but only if the vehicle owner has first obtained a letter of authori­ zation from nhtsa. to obtain authorization, the owner must show that the passenger side would carry either: 1) individuals with medical condi­ tions where the risks of airbag deployment exceed the risk of hitting. the dashboard or windshield on impact; or 2) an infant in a rear-facing child safety seat or a child aged 1 through 12 who needs to ride in the front of the car because the child must be constantly monitored due to a medical condi­ tion or because the back seat cannot accommodate the child. this policy has encountered significant resistance, most notably from dealers concerned about product liability exposure. such concerns ma~ow even more acute given the automotive industry's mounting financial. finally, while advanced airbag designs would be beneficial, it is far from clear that they will ever be 1 000/o effective in protecting children from airbag-related injuries. consequently, rear seating of child passengers will remain an important safety objective for years to come. e. a better approach: using comprehensive child passenger laws to avoid the avoidable despite the drawbacks of current child passenger safety laws, they are already in effect. accordingly, they serve as an important stepping stone to implementing safer child seating practices. nhtsa has already called for states to improve their existing seat belt laws as follows: 1. implement primary enforcement. 2. require all children to be restrained. 94. for a thoughtful discussion of the cummt economic woes of the industry, see da­ vid cole, sean mcalinden, kristen dziczek, debra manager, car research memorandum: the impact on the u.s. economy of a major contraction of the detroit three automakers, http://www.cargroup.org/documents/finaldetroitthreecontractionlmpact _3 _ 00 l.pdf 18 indiana health law review [vol. 7:1 3. require seat belts for children in all seats. 4. apply seat belt laws to all cars, vans and light trucks traveling in the state, regardless of place of registration. 95 however, the following measures are also needed to ensure a truly comprehensive approach to protecting child passengers: 5. require all adults to use seat belts. 6. expressly require rear seating for children age 12 and under unless no rear seat is available. 7. require that all car seats, restraints, and belts be used in accor­ dance with federal safety standards and manufacturers' directions. 8. charge the driver with responsibility for statutory compliance, us­ ing significant fines and penalties to maximize compliance. the "model child seating legislation" proposed ilifra uses all of these techniques to optimize child safety. studies have consistently shown that adults are more likely to wear seat belts when required by law, and adults who buckle up are more likely to buckle their children and also mod­ el safe behavior for the child.96 for the same reasons, rear seating for child­ ren must be expressly mandated since, as demonstrated in the seat belt context, state laws improve compliance when used in place of, or in addi­ tion to consumer education campaigns.97 holding the driver responsible for compliance clarifies and facilitates enforcement. a final recommendation for improving state laws is to link "proper" restraint to federal safety requirements a connection already articulated by many states.98 critics of this part of the proposal should recognize that, since the inception of motor vehicle safety regulation in the 1960's, both states and the federal government have played active but complementary roles. 99 the states have taken the lead in laws and regulations which deal with the role of human behavior in safety matters although they have fre­ quently needed strong federal incentives to do so.100 the u.s. department of transportation and its subsidiary, nhtsa, have dominated regulation of the design and manufacturing inputs to safety. consequently, nhtsa of­ ten works closely with manufacturers and insurers as well as sponsoring research.101 all of this makes new safety interventions more likely to 95. see supra note 73. 96 .. see nat'/ transp. sqfety bd. study: the performance and use of child restraint systems: seat belts and airbagsjor children in passenger vehicles, (u.s. dept. oftransp. 1996). 97. id. 98. see supra note 54 and accompanying text. 99. see supra note 48. 100. id 101. see, e.g., american automobile manufacturers association, association oflnter­ national automotive manufacturers, inc., automotive occupant restraints council, iihs, joint statement and recommendation on advanced air bag technology (1998) (describing collaboration among government, vehicle manufacturers and airbag suppliers to improve airbag safety). 2010] avoiding the unavoidable 19 emerge, be analyzed, and ultimately adopted at the federal rather than state level. thus, a state law which expressly links proper child restraint to fed­ eral safety standards can better evolve over time as new safety measures materialize through improvements in information and technology. in this way, a state law can avert the need for constant updating to account for new developments, a tremendous benefit given the complexity of the legislative process. a companion to this linkage in the state arena is for federal safety standards explicitly to incorporate seating position into all definitions of "child restraint system" as well as to require such information to be con­ tained in product warnings. manufacturers should support these state and federal legislative adaptations. if enacted and, more importantly, if en­ forced, it could improve safety and even reduce product liability claims. permitting evidence of improper seating position and/or restraint to be used in litigation could serve as an important incentive for safer seating beha­ viors. a few states already permit a "no seat belt defense" which can result in automatic reductions of all or part of a damage award to an unbelted plaintiff, but in the context of child seating, it may be difficult to justify where the passenger, as a child, is not easily held accountable for decisions regarding seating location or restraint.102 under the framework proposed in this article, parents transporting multiple children may find their vehicles less useful and might need to con­ front the expense of a larger vehicle. some parents may communicate less effectively with the child in the rear seat there may even be occasions when crashes occur during efforts by frustrated parents to control the beha­ vior of a child seated in the rear. to some extent, these and other inconve­ niences can be addressed by carefully and narrowly crafting exemptions to new child seating laws. for example, front seating of children should be permitted when a rear seat does not exist or is being used at full capacity. medical reasons for allowing a child to ride in the front, while rare, should be respected in new legislation. although such exceptions will make these laws more acceptable, it is important to recognize that rear seating laws do impose inconvenience and costs on vehicle owners, parents, and children. given the risks posed by airbags and the inherent safety advantages of the rear seat, however, the inconvenience and costs are essential to reduce life­ threatening, but readily avoidable risks to child passengers. f. model child occupant restraint and seating legislation chapter xxx, section 00: (a) definitions. for the purpose of this section, the following defi102. see llhs-hldi, child restraint. belt laws, http://www.iihs.org/laws/state_laws/ restrain.html. 20 indiana health law review [vol. 7:1 nitions will control: ( 1) a child is any person under the age of legal majority in this state; (2) an adult is any person who meets or exceeds the legal age of ma­ jority in this state; (3) a motor vehicle shall include any automobile, van carrying less than l 0 passengers, or light truck (but not an authorized emergency vehicle or public transportation) which is required by federal law to be equipped with safety belts under federal standards and is traveling in this state, re­ gardless of such motor vehicle's place of registration; (4) an occupant shall include the driver and any and all passengers within a motor vehicle. (b) (adults) each adult occupant in a motor vehicle shall be re­ strained by a properly secured and fastened seat belt which is installed and used in accordance with federal safety standards and manufacturers' direc­ tions. (c) (children age 13 and older) every driver who transports a child age 13 or older in a motor vehicle shall ensure that such child is restrained by a properly secured and fastened seat belt which is installed and used in accordance with federal safety standards and manufacturers' directions. (d) (children age 7 through 12) every driver who transports a child age 7 through 12 in a motor vehicle shall ensure that such child is seated in a rear passenger seat and restrained by a properly secured and fastened seat belt which is installed and used in accordance with federal safety standards and manufacturers' directions. (e) (children age 5 through 6) every driver who transports a child 5 through 6 years of age and weighing 40 to 60 pounds in a motor vehicle shall seat such child in a child passenger ''booster" restraining system which is located in a rear passenger seat and installed and used in accordance with federal safety standards and manufacturers' directions. (f) (children age 4 and under) every driver who transports a child 4 years of age or younger and weighing 40 pounds or less in a motor vehicle shall seat such child in a child passenger restraining system which is located in a rear passenger seat and is installed and used in accordance with federal safety standards and manufacturers' directions. (g) (priority in rear seating) in the event that all rear and front pas­ senger seats will be occupied by children age'12 and under, priority in rear seating must be given first to children age 4 and under, second to children age 5 through 6, third to children aged 7 through 12, and last to occupants age 13 and older. (h) (emergency and medical exemptions) the provisions of this sec­ tion shall not apply when emergency attention is required for the child's immediate and personal safety, or where a licensed medical doctor has indi­ cated in writing that the child's medical condition necessitates an exemp­ tion from the requirements of this section. in such instances, the driver shall carry a copy of the medical doctor's determination ofthe child's med2010] a voiding the unavoidable 21 ical exemption from the requirements of this section. (i) (primary enforcement) a violation of this section shall be consi­ dered a primary offense and a motor vehicle may be stopped by a police officer solely for failure to comply with this section. (j) (fines and penalties) upon a first conviction under this section, the defendant shall be punished by a fine of not less than $100.00. the failure to provide a child restraint system or seat belt for more than one child in the same vehicle at the same time as required by this section shall be treated as separate offenses. upon a subsequent conviction of an offense under this section, the de­ fendant shall be punished by a fine of not less than $250.00 per offense plus all costs of court. (k) (evidentiary effect) a violation of this section may be considered as evidence of the driver's and/or adult occupant's comparative or contribu­ tory negligence in any civil suit or of the driver's or adult passenger's crim­ inal negligence or recklessness in any criminal action arising out of any motor vehicle accident. a violation of this section may not be considered as evidence of a child's comparative or contributory negligence or reckless­ ness in any civil or criminal action. (i) (collection of data) the court imposing a fine for any violation under this section shall forward a record of the disposition of the cases an­ nually to the department of public safety for the sole purpose of data col­ lection on a county by county basis. lll. conclusion for adults, airbags have been a major innovation in motor vehicle safety. their attendant risks to children will surely be reduced over time as technology advances, but may never be completely eradicated. in the meantime, a simple and effective solution is available: seat children in the rear of the vehicle. government should not shirk its special obligation to protect children, especially since the intervention is so straightforward. better state laws can reduce pediatric airbag injuries, ease enforcement of seat belt requirements, and enhance overall child safety. this objective should be accomplished through consumer education campaigns as well as carefully drafted state child restraint laws and federal safety standards. the "message" of all educational, legislative and regula­ tory efforts must tightly and consistently integrate seating position with seat belt use. state laws must be primarily enforceable and require rear seating as an essential feature of proper child restraint for all children through the age of 12. the statutory requirement of "proper child restraint" must in­ clude seating location and reflect evolving federal safety standards. in turn, federal standards must incorporate seating location into all child restraint provisions. it is hoped that such a comprehensive strategy will reduce the hazards of airbags for child passengers while preserving their safety advan22 indiana health law review [vol. 7:1 tages for adults. hospital liability: drawing a fine line with informed consent in today' s evolving health care arena shelley s. fraser· introduction the quality of health care and its effects on patient care are priority concerns in today' s highly regulated and ever changing health care delivery system. a hospital is a multi-care facility, integrating all aspects of patient care, and operating as a profit making entity. 1 hospitals hold themselves out to be health care providers, and patients rely on these entities to provide appropriate care. many hospitals advertise and market their equipment, ser­ vices, staff, and physicians. a hospital has a duty to ensure that its physicians abide by proper patient care standards. when a patient does not select his or her physician before entering the hospital, the patient must trust that the hospital has assembled a competent staff that can and will perform the procedure properly. in such circumstances, a hospital has a stronger role in ensuring patient safety and care. the future ofhospitalliability may involve accountability for physicians who fail to obtain informed consent from their patients and who work primarily within the walls of the hospital. informed consent is an important aspect of patient care and is an evolving cause of action in medical malprac­ tice liability. a majority of hospitals already assert some control over the informed consent process, by way of policies and procedures, forms, compliance with standards set by the joint commission on accreditation of healthcare organizations (jcaho), and by hiring physicians to perform procedures that require informed consent. hospital control over the conduct of its staff or physicians is a consideration for liability.2 if courts decide to expand certain theories of liability, hospitals will have to be aware of the potential for legal responsibility. * j.d. candidate, 2004, indiana university school of lawindianapolis; b.a., 1999, indiana university, indianapolis, indiana. i would like to thank professor lawrence wilkins and shannon shaw for their insight and guidance in writing this note. 1. see david h. rutchik, the emerging trend of corporate liability: courts' uneven treatment of hospital standards leaves hospitals uncertain and exposed, 47 v and. l. rev. 535,538 (1994). "hospitals not only strive to be a source of pride in the local community, but they also seek to avoid operating at a financial loss. regardless of whether they are profit­ seeking enterprises, they are run much like any large corporation and must operate in a fiscally responsible manner." simmons v. tuomey reg'l med. ctr., 533 s.e.2d 312, 316 (s.c. 2000). 2. see frank m. mcclellan, tort liability of physicians, hospitals, and other health care providers, c286 a.l.i.-a.b.a. 1, 18 (1993). 254 indiana health law reyrnw [vol. 1:253 the doctrine of informed consent could be expanded to include hospital liability for the actions of nonemployee physicians when such physicians are determined to be agents of the hospital by ostensible authority or by the establishment of a nondelegable duty on behalf of the hospital. courts may take the position that by making hospitals responsible for a portion of the informed consent process when a procedure is performed by a physician who works mainly within the walls of the hospital, a hospital will provide higher quality patient care and confidence throughout the patient population. patients do not generally choose their radiologist, anesthesiologist, path­ ologist, or emergency room physician. these physicians are hired to perform their duties within the hospital, whether in servant/agent relationships or as independent contractors. this lack of patient autonomy, in selecting a physician, may be recognized by courts as a foundation for imposing a duty on hospitals in order to compensate for the decline in patient control. patient autonomy and self-determination are th~ founding principles of informed consent. as these principles are reduced in strength by patients not being able to select physicians for specialty procedures or emergency care, hospitals may be held more accountable by the legal system. on august 28, 2002, the pennsylvania supreme court, in a split decision, drew a fine line concerning hospital liability for lack of informed consent.3 in a case of first impression, valles v. albert einstein medical center, the court held that "as a matter of law, a medical facility lacks the control over the manner in which the physician performs his duty to obtain informed consent so as to render the facility vicariously liable."4 the court reasoned that a "medical facility cannot maintain control over this aspect of the physician-patient relationship."5 however, justice nigro, dissenting in valles, reasoned that the informed consent procedure can be viewed as within the scope of the physician's employment because the underlying procedure cannot be performed without it. 6 informed consent acts as a prerequisite and is not severable from the procedure.7 as long as the procedure is within the scope of the physician's employment, the informed consent to conduct the procedure must also be included in that scope. the dissent's view reflects realities in today's health care delivery system. this note will discuss the background and evolution of hospital liability related to the doctrine of corporate liability and the history of informed consent. it will analyze the valles decision, explore the theories of non­ delegable duty and ostensible agency authority, and examine emergency room physician and hospital liability, the hospital's involvement in the informed 3. valles v. albert einstein med. ctr., 805 a.2d 1232 (pa. 2002). 4. ld. at 1239. 5. ld. 6. ld. at 1241-42. 7. ld. at 1241. 2004] drawing a fine line with informed consent 255 consent process, and patients' reliance on hospitals. public policy, costs, and the effects on patient care will also be reviewed. finally, the note will discuss the possibility of a hospital being held liable for failure to obtain informed consent under the theories of agency, non-delegable duty, corporate liability, and voluntary assumption of duty. l corporate liability theory sweeps hospitals into the realm of 0bugation liability involving hospitals has evolved over time. in the early 1900s, hospitals were not liable for any acts of malpractice committed by their physicians or nurses because of their charitable status. 8 as hospitals became more like businesses, this immunity ceased to exist,9 and hospitals became liable for the negligent acts of their employees. 10 however, because physicians were independent contractors, liability still did not attach to hospitals for the physicians' negligent acts. with the passage of time, hospital liability has expanded and hospitals have become more accountable to their patients under the doctrine of corporate liability .11 the doctrine of corporate liability was first recognized in the landni.ark case of darling v. charleston community memorial hospital, in which the court held that a duty of care was owed to the patient by the hospital independent from the duty owed by a private physician.12 the court reasoned that the idea a hospital does not treat the patients or does not act through its physicians and staff is no longer accurate. 13 ''under the doctrine of hospital corporate liability, a hospital has a nondelegable, direct duty to provide adequate care to all of its patients."14 the duty does not derive from the respondeat superior theory or the principal-agent theory ''because the hospital's liability flows directly from the hospital to its patients."15 because the hospital owes a direct duty to the patient, the injured patient does not have to establish negligence on the part of a third party. hospital 8. schloendorffv. soc'y of n.y. hosp., los n.e. 92,93-94 (n.y. 1914), abrogated by bing v. thunig, 143 n.e.2d 3, 9 (n.y. 1957). 9. see bing, 143 n.e.2d at 9. 10. see id. the court reasoned that the "hospital's liability must be governed by the same principles of law as apply to all other employers." id. 11. see rutchik. supra note 1, at 536. see also kenneth s. abraham & paul c. weiler, enterprise medical liabiuty and the evolution of the american health care system. 108 harv. l. rev. 381, 389 (1994). 12. darling v. charleston cmty. hosp., 211 n.e.2d 253, 258 (til. 1965) in this case, the plaintiff suffered a broken leg playing football. the physician applied a cast too tightly, which cut off the blood flow and thus circulation to the plaintiff's lower leg. an amputation of the lower leg was necessary. the plaintiff brought an. action to recover damages for negligent hospital treatment and he prevailed. id. 13. id. at 257. 14. rutchik, supra note 1, at 536. 15. id. 256 indiana heal til law review [vol. 1:253 duties under corporate liability include showing: (1) duty to furnish adequate equipment and facilities; (2) duty to formulate and follow rules and policies; (3) duty to select physicians properly; and (4) duty to supervise staff physicians properly. 16 the pennsylvania supreme court adopted the doctrine of corporate liability in thompson v. nason hospita/. 17 the court recognized the aforementioned duties and held that a hospital is liable when it "fails to uphold the proper standard of care owed [to] its patient."18 a patient must demonstrate that the "hospital had actual or constructive knowledge of the defect or procedures which created the harm" and that the hospital's negligence was a "substantial factor in bringing about the harm."19 justice flaherty, dissenting in thompson, asserted that hospitals should not be the "guarantors of the quality of care" provided by a physician who is an independent contractor. 20 he asserted that this extension of liability would be expanded beyond the hospital and into the corporate business world and that all businesses could be held responsible for the acts of independent contractors. 21 justice flaherty reasoned that this extension of liability would impose detrimental financial burdens on corporations, including hospitals. 22 traditionally, informed consent has been the sole responsibility of the physician and hospitals have been exempt from liability in this area.23 the main purpose of an action in informed consent is to protect individual autonomy (including the right to choose or decide) and bodily integrity.24 16. /d. at 540-48. 17. thompson v. nason hosp., 591 a.2d 703 (pa. 1991). 18. /d. at 708. 19. /d. 20. /d. 21. /d. 22. /d. at 709. see also mark e. milsop, corporate negligence: defining the duty owed by hospitals to their patients, 30 duq. l. rev. 639 (1992). an offspring of corporate liability, enterprise liability was a proposal for malpractice reform in the 1990s. abraham & weiler, supra note 11, at 381. under this approach, malpractice liability would be shifted to the health care organizations where patients are treated and away from individual physicians. /d. the idea of enterprise liability is derived from the historic doctrine of respondeat superior. /d. at 383. the proposal was not accepted by the medical community and was opposed by the physician­ owned liability insurance companies because of the serious threat to their market. john f. bales, ill & lisa a. demarco, selected topics in medical malpractice litigation, 669 practisingl.inst. com. l. &prac. course handbook series 381,418 (1993). 23. see kelly v. methodist hosp., 664 a.2d 148, 151 (pa. super. ct. 1995) ("every jurisdiction that has considered the issue ... has declined to impose upon hospitals the general duty to obtain informed consent."); see also suzanne k. ketler, the rebirth of informed consent: a cultural analysis of the informed consent doctrine after scheiber v. physicians insurance co. of wisconsin, 95 nw. u. l. rev. 1029, 1037 (2001). 24. see jessica w. berget al., informed consent 11-12 (2001). see also bryan j. warren, pennsylvania medical informed consent law: a call to protect patient autonomy rights by abandoning the battery approach, 38 duq. l. rev. 917, 927 (2000) ("informed consent has ancient roots ... in the concept of individual bodily integrity free from interference without consent or legal authority."). 2004] drawing a fine line with informed consent 257 justice cardozo set forth the founding precedent with regard to the principle of bodily self-detennination in schloendorffv. society of new york hospital, by stating that "[ e ]very human being of adult years and sound mind has a right to detennine what shall be done with his own body."25 informed consent became directly related to physicians and the standards they employ when the leading case of canterbury v. spence was decided.26 prior to canterbury, the point of reference was the "physician standard" or the custom of the medical community. 27 canterbury injected a new "rea­ sonable patient" standard into the informed consent doctrine. the measure­ ment was an objective one considering the "degree of care which a reasonably prudent person would have exercised under the same or similar circum­ stances."28 the court declared that the standard is set by law and is not one that physicians may or may not choose to impose upon themselves. 29 the jurisdictions in the united states are evenly split on the two standards, with about half still utilizing the traditional physician-centered standard.30 some commentators have asserted that the reasonable patient standard does a better job of protecting individual autonomy?1 another transformation of the doctrine of informed consent is the theory under which an action is brought. at common law, the action was rooted in the theories of battery or contract (breach of contract or breach of pa­ tient/physician fiduciary relationship).32 pennsylvania is the only state that still requires an action in battery.33 the majority of jurisdictions base the action on a negligence theory.34 the main elements necessary to establish an 25. schloendorffv. soc'y of n.y. hosp., 105 n.e. 92,93 (n.y. 1914). 26. canterbury v. spence, 464 f.2d 772 (d.c. cir. 1972). 27. ld. at 783. 28. /d. at 784 (quoting wash. hosp. ctr. v. butler, 384 f.2d 331, 335 (d.c. cir. 1967)). 29. ld. at 784. 30. ketler, supra note 23, at 1037. see also berget al., supra note 24, at 48. florida follows the traditional view and "measures a physician's duty by the professional medical stand­ ard of what a reasonable physician would disclose under the same or similar circumstances." roxanne beth axelrod, informed consent, 36 fla. jur. 2d medical malpractice § 40 (2002). for a description of the standard utilized and physician's scope of disclosure for each state see ketchup v. howard, 543 s.e.2d 371, 381-86 (ga. ct. app. 2000). 31. see, e.g., ketler, supra note 23, at 1038. 32. ketler, supra note 23, at 1036; warren, supra note 24, at 918. 33. see barry r. furrow et al., health law 312 (2d ed. 2000); kelly v. methodist hosp., 664 a.2d 148, 150 (pa. super. ct. 1995) ("we are compelled to analyze informed consent cases under a battery theory until and unless our supreme court decides to recognize an informed consent cause of action grounded in negligence."). 34. see ketler, supra note 23, at 1036; warren, supra note 24, at 918. the breach of contract theory has been held as being against public policy. see tatham v. hoke, 469 f. supp. 914,918-19 (w.d.n.c. 1979) (holdingunenforceableinformedconsent as a contract); emory univ. v. porubiansky, 282 s.e.2d 903, 905 (ga. 1981); grimes v. kennedy krieger inst., inc., 782 a.2d 807, 858 (md. 2001) (reasoning informed consent as a contract is only acceptable in non-therapeutic research projects under certain circumstances). see generally maxwell j. mehlman, fiduciary contracting limitations on bargaining between patients and health care providers, 51 u. prrr. l. rev. 365 (1990). 258 indiana health law revlew [vol. 1:253 informed consent cause of action include showing (1) "risk was inherent to the medical or surgical procedure undertaken" and (2) the "risk was material, in that it could influence a reasonable person's decision to consent to the procedure."35 a patient must also prove that a reasonable person would not have consented to the procedure if the material risk had been disclosed and that the lack of informed consent is the proximate cause of the injury. 36 ll. valles v. albert einstein medical center in valles v. albert einstein medical center,31 the decedent's sister, administratrix of patient's estate, brought an informed consent action against the physician and a vicarious liability claim against the albert einstein medical center (aemc). the decedent's sister, appellant, alleged that the decedent (valles) was not adequately informed of the risks associated with the contrast dye used in an aortogram (a radiology procedure) and was not advised of alternatives to the procedure. valles, who was diabetic, presented with a possible abdominal aneurysm. an aortogram was ordered to confirm and identify the location of the aneurysm. 38 a radiology resident obtained written informed consent from valles for the procedure to be performed by the radiologist, dr. allen. the written consent did not include the risk of renal damage or alternatives to the procedure. dr. allen stated that it was his routine practice to inform the patient that the dye from the aortogram might damage the kidneys. following the procedure, valles's kidney function worsened and he subsequently went into renal failure. 39 the appellant asserted that the hospital was liable because it was responsible for the intentional torts of its employee-physicians under the principle of respondeat superior and the hospital had "an obligation to oversee all persons who practice[ d) medicine within its walls."40 therefore, appellant reasoned that the ''hospital as an employer and health care provider in its own right maintain[ed] a right of control in the relationship sufficient to justify the imposition of liability.'>41 appellee aemc contended that the responsibility 35. elements of cause of action, 42a tex. jur. 3d healing arts&: institutions§ 214 (2002). see also canterbury v. spence, 464 f.2d 772 (d.c. cir. 1972). 36. elements of cause of action, supra note 35. see also terry 0. tottenham, informed consent, 1 hbalthl. prac. guide § 9:21 (2002); lees. kreindler et al., checklist for medical malpractice, 15 n.y. prac. series, n.y. torts § 13:46, 6 (2002). exceptions to the requirement of infonned consent include the following: emergency; disclosure would be detrimental to patient's health (cause hann); incompetence; or waiver by the patient. see canterbury, 464 f.2d at 788-89; berget al., supra note 24, at 75-125; ketler, supra note 23, at 1035-36. 37. valles v. albert einstein med. ctr., 805 a.2d 1232 (pa. 2002). 38. /d. at 1233-34. 39. /d. at 1234. 40. /d. at 1236. 41. ld. 2004] drawing a fine line with informed consent 259 of informed consent rested solely with the physician performing the procedure and that this duty was non-delegable.42 the court addressed the issue of whether a hospital could be vicariously liable for an employee-physician's failure to obtain informed consent as a matter of law.43 finding that the hospital was not liable, the court reasoned that even if it assumed "arguendo., that dr. allen was an employee of the hospital, "a battery which results from a lack of informed consent is not the type of action that occurs within the scope of employment. •>44 the court noted that it did not want to disrupt the patient-physician relationship with an element of control by the hospital and stated the idea was "improvident and unworkable . .,45 justice nigro dissented and reasoned that in an action brought under vicarious liability, an employee's conduct is within the scope of employment for purposes of vicarious liability if: (1) it is of a kind and nature that the employee is employed to perform; (2) it occurs within the authorized time and space limits of the employment; (3) it is actuated at least in part by a purpose to serve the employer; and (4) the use of force is expected by the employer and then force is intentionally used against another.46 according to the dissent's view, the aortogram was a radiology proce­ dure that dr. allen was employed by aemc to perform. 47 the aortogram could not be performed without obtaining informed consent from the patient. if the aortogram was within the radiologist's scope of employment, then the informed consent must also be included in that scope. accordingly, justice nigro asserted that it is well-established in pennsylvania that informed consent is a prerequisite to any surgery or operative procedure.48 the valles court did not decide whether the radiologist was an employee, agent, or independent contractor. the exact employment status of 42. id. 43. valles, 805 a.2d at 1236. ''vicarious liability refers to those principles which permit the attribution of the acts of one person to another by virtue of the relationship between the two, such as respondeat superior." timothy a. hickey, jr., vicarious liability generally, 14 ga. iur. personal injury & torts § 36:88 (2002). 44. valles, 805 a.2d at 1239. as discussed previously, pennsylvania still adheres to the battery theory for an action in informed consent. see supra note 33 and accompanying text. 45. valles, 805 a.2d at 1239. the lower court had "determined that nothing in the record indicated that aemc exercised control over the manner in which allen was to perform radiology work." id. at 1235. 46. jd. at 1241. justice nigro believed there was enough evidence that the question of whether dr. allen was an employee should have been submitted to the jury. id. at 1242. 47. id. 48. id. at 1241. justice nigro refers to morgan v. macphail, 704 a.2d 617, 619 (pa. 1997) (''it has long been the law in pennsylvania that a physician must obtain informed consent from a patient before performing a surgical or operative procedure."). 260 indiana heal1h law rev1bw [vol. 1:253 a physician to a hospital can make a difference in the outcome of a legal action with respect to hospital liability. when a physician is found to be an independent contractor of the hospital, and not an employee or agent, the hospital is generally not liable for the physician's "professional judgment" unless the hospital was negligent in selecting the physician or asserted control over the physician's activities.49 ill. excep110ns to the aging independent contraci'or defense labels placed on physicians by contracts or relationships are not dis­ positive. 50 under circumstances ''where the hospital retains control over the time, method, and manner of treating patients, the .hospital may be held responsible for the physician's actions. identification of the physician as an independent contractor in the physician's contract with the hospital is not controlling. "51 one of the well-recognized exceptions to non-liability for independent contractors includes the ''nondelegable duty" theory.52 this theory ''provides that an employer such as a health care institution can be held liable for the negligence of an independent contractor performing certain 'nondelegable' duties which are imposed on the employer by statute, contract, charter, or common law."53 a common example of this exception involves hospital liability in connection with emergency room physicians. 54 49. timothy a. hickey, jr., hospital's responsibility for physicians, 14 ga.jur.person­ al injury &: torts§ 36:91 (2002). see also ward v. lutheran hosps. & homes soc'y of am., inc., 963p.2d 1031 (ala.1998);petriellov. kalman,576a.2d474(conn.1990);cedarsmed. ctr., inc. v. ravelo, 738 so.2d 362 (fla. dist. ct. app. 1999); churkey v. rustia, 768 n.e.2d 842 (dl. app. ct. 2002); giese v. stice, 567 n.w.2d 156 (neb. 1997). 50. keller v. mo. baptist hosp. of sullivan, 800 s.w.2d 35, 37 (mo. ct. app. 1990). 51. hickey, supra note 49. see also goins v. tucker, 489 s.e.2d 857, 861 (ga. ct. app. 1997), abrogated by 533 s.e.2d 82 (ga. 2000) (setting forth that "labels ascribed by the contract ... are not determinative of their legal relationship") (overruled on other grounds); doctors hosp. of augusta, inc. v. bonner, 392 s.e.2d 897,905 (ga. ct. app. 1990) ("such labeling in a contract is not detenninative of the status of any such person and other factors may negate the label."). 52. bales & demarco, supra note 22, at 466. the tenn nondelegable duty is somewhat misleading. a person may delegate a duty to an independent contractor, but if the independent contractor breaches that duty by acting negligently or improperly, the delegating person remains liable for that breach. it actually is the liability, not the duty, that is not delegable. simmons v. tuomey reg'l med. ctr., 533 s.e.2d 312, 317 (s.c. 2000). 53. bales & demarco, supra note 22, at 466. see also darling v. charleston cmty. hosp., 211 n.e.2d 253, 257 (ill. 1965) (reasoning that the "standards for hospital acci'e(ijtation, the state licensing regulations and the ... bylaws demonstrate that the medical profession and other responsible authorities regiu'd it as both desirable and feasible that a hospital assume certain responsibilities for the care of the patient''). 54. bales & demarco, supra note 22, at 467, 474. almost all hospitals provide emer­ gency care and the majority of emergency rooms are staffed by physicians who are independent contractors. 2004] drawing a flnb line wlfh informed consent 261 in simmons v. tuomey regional medical center, the south carolina supreme court held that a non-delegable duty was correctly imposed by the appellate court on the hospital for the negligence of an emergency room physician.55 the court looked at other industries 'and relationships that possessed a non-delegable duty and concluded that a hospital owed a non­ delegable duty to provide competent emergency care to its patients. s6 the court noted that the holding was not limited to emergency room physicians, but it was limited to "situations in which a patient seeks services at the hospital as an institution, and is treated by a physician who reasonably appears to be a hospital employee."57 similarly, in jackson v. power, the alaska supreme court held ''that a general acute care hospital's duty to provide physicians for emergency i'oom care is non-delegable. "58 the court also compared the hospital with other industries that have non-delegable duties and reasoned that pubic policy mandates the same protection in an emergency room. 59 the court stated, "[w]e simply cannot fathom why liability should depend upon the technical employment status of the emergency room physician who treats the patient. it is the hospital's duty to provide the physician, which it may do through any means at its disposal.'t60 , jackson was later superceded in part by a 1997 alaska statute declaring immunity to hospitals for negligent acts or omissions of emergency room physicians who are independent contractors and not employees, as long as the hospital provides notice of the physicians' employment status.61 although the case is no longer good law in alaska, the reasoning presented by the court could be applied in other jurisdictions whose legislatures have not codified 55. simmons, 533 s.e.2d at 323 (modifyingtheappellatecourt's ruling by stating that the duty was not absolute and that the elements of section 429 of the restatement (second) oftorts must be satisfied). see infra note 80 and accompanying text see also irving v. doctors hosp. of lake worth, inc., 415 so.2d 55, 59 (fla. dist ct. app. 1982); martell v. st. charles hosp., 523 n.y.s.2d 342, 352 (n.y. sup. ct. 1987). 56. simmons, 533 s.e.2d at 317-18 (cojlsidering the non-delegable duty involved with employer-employee relationship, the landlord-tenant relationship, common carriers, bail bondsman, and municipalities). i d. 57. id. at 323. 58. jackson v. power, 743 p.2d 1376, 1385 (alaska 1987). 59. id. at 1383-84. 60. id. at 1385. 61. alaska stat. § 09.65.096(a) (michie 1997). the statute states: a hospital is not liable for civil damages as a result of an' act or omission by an emergency room physician who is not an employee or actual agent of the hospital if the hospital provides notice that the emergency room physician is an independent contractor and the emergency room physician is insured .•.. 262 indiana health law review [vol. 1:253 immunity to hospitals in these circumstances. nonetheless, other courts have declined to extend the non-delegable duty to hospitals.62 corporate liability has evolved to diminish the effects of the independ­ ent contractor defense. the court in urban v. spohn hospital held that a hospital could be liable for its own negligence involved in the informed consent process. 63 the plaintiff informed hospital personnel several times that she did not want a certain procedure and had not consented to it. neverthe­ less, the procedure was performed. the treating physician was not informed by the hospital personnel ofthe patient's wishes.64 the court stated, "we cannot say as a matter of law that merely because the physician is ultimately responsible for obtaining consent for medical procedures, that a hospital is therefore totally insulated from liability for all acts relating to such proce­ dures."65 similarly, the supreme court of kentucky in keel v. st. elizabeth medical center noted "incidentally" that the hospital had a duty of informed consent because the kentucky statute places the duty upon "health care providers."66 in keel, the court was referring to the duty of hospital personnel to obtain informed consent prior to performing a ct scan ordered by the patient's physician.67 in addition to urban and keel, the pennsylvania superior court in friter v. jolab corp. held that the hospital could be liable for failing to obtain informed consent with regard to investigational studies.68 the court reasoned that because the hospital assumed an independent duty to obtain informed consent, and because the hospital intended the patient ''to come in contact with a foreign substance by way of the investigational study, there is no reason why the hospital should not be held liable under an informed consent cause of action."69 the court's holding was narrowly drawn to relate only to informed consent of investigational or research type studies; however, the reasoning may be susceptible to broad application in the future. despite the aforementioned cases, courts generally are reluctant to im­ pose any form of liability on a hospital for the failed informed consent of a procedure. other courts have rejected the urban court reasoning, and some 62. see kelly v. st. luke's hosp. of kansas city, 826 s.w.2d 391, 395 (mo. ct. app. 1992); estates of milliron v. francke, 793 p.2d 824, 827 (mont. 1990) (refusing to apply non­ delegable duty doctrine to hold hospital liable for the negligent acts of a radiologist, an · independent contractor); baptist mem'l hosp. sys. v. sampson, 969 s.w.2d 945, 949 (tex. 1998). 63. urban v. spohn hosp., 869 s.w.2d 450, 452-53 (tex. app. 1993). 64. id. at 452. 65. id. at 453. 66. keel v. st. elizabeth med. ctr., 842 s.w.2d 860,862 (ky. 1992). 67. ld. at 860-61. 68. friter v. lolab corp., 607 a.2d 1111, 1116 (pa. super. ct. 1992). see also corrigan v. methodist hosp., 158 f.r.d. 70, 73 (e.d. pa. 1994). 69. friter, 607 a.2d at 1116. 2004] drawing a fine line with informed consent 263 have held that even though a hospital meets the definition of a health care provider, in many state statutes the hospital does not have a duty to obtain informed consent.70 the supreme court of nebraska, in giese v. stice, decided that imposing liability on the hospital would not benefit the patient and would result in a disruption of the patient-physician relationship. 71 the historical mentality has been that hospitals do not practice medicine and therefore should not be held accountable for obtaining informed consent. 72 chief justice compton of the alaska supreme court agreed, stating, "hospitals do not practice medicine independently of the individuals they employ."73 however, he contended that alaska's statute, which uses the term "health care provider," meant to "impose some responsibility on hospitals to obtain patients' informed consent" and that a hospital should be liable for failing to obtain informed consent when an employee performs a procedure ordered by an independent physician.74 justice compton noted that the statute imposes a duty for the hospital to make sure patients are informed, either by directing the treating physician or by taking their own initiative. 75 he suggested a hospital would be in compliance with this duty by documentation in the patient's medical record or chart. 76 even though the urban, keel, and friter courts currently represent the minority view, they may be the beginning of a trend to expand the liability of informed consent outside the physician-patient relationship. the dynamic relationship between a physician and patient has traditionally been one of the leading reasons for not extending liability for informed consent. in 1972, the rhode island supreme court defined the relationship as a "one-on-one affair.'m the valles court was worried about disrupting this "individualized relationship."78 however, the court did not attach any significance to the fact that a resident obtained the initial informed consent and the radiologist sub­ sequently added to it. 79 this dynamic relationship may be slowly deteriorating in today' s fast paced, technically advanced delivery of health care. 70. see giese v. stice, 567 n.w.2d 156, 164 (neb. 1997); ward v. lutheran hosps. & homes soc'y of am., inc., 963 p.2d 1031, 1038 (alaska 1998). 71. giese, 567 n.w.2d at 164. 72. see pauscher v. iowa methodist med. ctr., 408 n.w.2d 355, 362 (iowa 1987). see also ward, 963 p.2d at 1040; schloendorffv. soc'y of n.y. hosp., 105 n.e. 92, 93-94 (n.y. 1914). 73. ward, 963 p.2d at 1040. 74. id. at 1040-41. 75. id. at 1041. 76. id. at 1042. 77. wilkinson v. vesey, 295 a.2d 676,688 (r.i. 1972). 78. valles v. albert einstein med. ctr., 805 a.2d 1232, 1239 (pa. 2002). 79. i d. at 1232. "under the ordinary rules of agency law, the radiologist may delegate the process of obtaining consent to an agent, such as a nurse or even a referring physician, if the agent accepts the responsibility." stewart r. reuter, an overview of infonned consent for radiologists, 148 am. j. roentgenology 219, 224 (1987). the radiologist does this at his own risk. id. 264 indiana health law review [vol. 1:253 other courts have found hospitals liable for independent contractors under theories of vicarious liability. 80 hospitals have been held accountable for negligence involving emergency room physicians utilizing apparent or ostensible agency authority.81 the reasoning behind the ostensible agency exception is that hospitals hold themselves out as providing emergency services, and the patients do not know which personnel are employees and which are independent contractors. 82 the patients rely on the hospital to pro­ vide emergency care, not the individual physician. the theory of ostensible agency "applies when a patient comes to a hospital and the hospital selects a doctor to serve the patient. the doctor has apparent authority to bind the hospital because a patient may reasonably assume that a doctor selected by the hospital is an agent of the hospital."83 the non-delegable duty and the ostensible agency theories could very easily be applied to all physicians who conduct virtually all of their work within the walls of the hospital. similar to jackson, the pennsylvania supreme court in valles could have inquired as to whether the hospital had 80. indiana has expressly adopted the theory of ostensible agency set forth in the restatement (second) oftorts section 429 for the hospital setting. sword v. nkc hosps.,lnc., 714 n.e.2d 142, 152 (ind. 1999). the indiana supreme court held that a hospital could be vicariously liable for the negligent acts of an independent contractor anesthesiologist if an agency relationship was established and if the patient was injured by the anesthesiologist. ld. at 152-53. 81. abraham & weiler, supra note 11, at 387. the restatement (second) of agency defines an agent or servant as: one who represents that another is his servant or other agent and thereby causes a third person justifiably to rely upon the care or skill of such apparent agent is subject to liability to the third person for harm caused by the lack of care or skill of the one appearing to be a servant or other agent as if he were such. restatement (second) of agency: reilance upon care or skill of apparent servant or other agent§ 267 (1958). see alsotherestatement(second) oftortssection429, which describes an employer's liability for independent contractors as follows: one who employs an independent contractor to perform services for another which are accepted in the reasonable belief that the services are being rendered by the employer or by his servants, is subject to liability for physical harm caused by the negligence of the contractor in supplying such services, to the same extent as though the employer were supplying them himself or by his servants. restatement (second) of torts: negugence in doing work wmch is accepfed in reilance on the empwyer's doing the work himself§ 429 (1965). 82. abraham & weiler, supra note 11, at 388. 83. schlotfeldt v. charter hosp. of las vegas, 910 p.2d 271, 275 (nev. 1996). "by furnishing a physician to a patient without a prior relationship with the physician, the hospital is deemed to represent that the physician is its employee and asks the patient to accept the physician based upon its reputation and not that of the physician." timothy a. hickey, jr., physician as hospital's apparent agent, 14 ga. jur. personal injury & torts§ 36:92 (2002). questions for the jury involving ostensible agency include: (1) [w]hether a patient entrusted herself to the hospital, (2) whether the hospital selected the doctor to serve the patient, (3) whether a patient reasonably believed the doctor was an employee or agent of the hospital, and ( 4) whether the patient was put on notice that a doctor was an independent contractor. schlotfeldt, 910 p.2d at 275. 2004] drawing a fine llne wrrh informed consent 265 provisions in its by-laws to provide radiology services, whether a state statute required acute care hospitals to provide radiology services, and whether the hospital adhered to the jcaho standards to find a nondelegable duty on behalf of the hospital. 84 once a nondelegable duty is established for the radiology services, the duty would have to include the informed consent because of the immutable rule that the services cannot be performed without such consent. radiologists obtain informed consent from patients daily in the "procedure-oriented nature" of their practice area. 85 a radiologist is very similar to the emergency room physician because the vast majority of patients do not personally choose or know the radiologist prior to a procedure. similar to the nondelegable duty, the ostensible agency theory is directly applicable to radiologists. the theory was upheld against a hospital for the negligence of a radiologist, who was an independent contractor, in jennison v. providence st. vincent medical center.86 the court reasoned that the "[h]ospital held itself out as providing radiology services to the public" and the patient did not have actual knowledge that the radiologist was a non­ employee, thus satisfying the two elements of ostensible or apparent agency. 87 similarly, the supreme court of ohio held a hospital liable under the doctrine of agency by estoppel. 88 the court stated that a hospital could be held accountable for the ''negligence of independent medical practitioners ... if it holds itself out to the public as a provider of medical services and in the absence of notice or knowledge to the contrary, the patient looks to the hospital, as opposed to the individual practitioner, to provide competent medical care."89 a hospital can attempt to avoid this liability by informing the patient of the exact relationship it has with the physician.90 other suggestions for evading liability include the following: 84. jackson v. power, 743 p.2d 1376, 1382-83 (alaska 1987). 85. reuter, supra note 79, at 219. 86. jennison v. providence st. vincent med. ctr., 25 p.3d 358, 367-68 (or. ct. app. 2001). 87. /d. at 367. the two elements are the hospital holds itself out as medical provider and the patient develops reliance because she is unaware of physician's status as an independent contractor. /d. 88. clarkv.southviewhosp.&familyhealthctr.,628n.e.2d46(0hio1994). agency by estoppel involves representation and reliance. "[r]epresentation is satisfied when the hospital holds itself out to the public as a provider of medical services." /d. at 53. reliance is satisfied by the patient looking to the hospital for medical care, instead of her personal or a specific physician. /d. see also restatement (second) of agency§ 267, supra note 81. agency by estoppel involves a stricter standard than ostensible agency because actual reliance is required and not just a belief upon representations. jennison, 25 p.3d at 364. 89. clark, 628 n.e.2d at 53. 90. hickey, supra note 83. see also sword v. nkc hosps., inc. 714 n.e.2d 142, 152 (ind. 1999) (noting that hospital liability may be avoided by providing the patient with ''mean­ ingful notice" of the relationship with an independent contractor physician at the time of admis­ sion). 266 (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) indiana health law review [vol. 1:253 providing notice of physicians' independent contractor status, training staff to refer to physicians as independent and private, posting signs in hospital that state physicians are independent contractors and not employees of the hospital,91 brochures, avoiding advertising with possessive nouns when referring to physicians, not permitting physicians to use the hospital name unless acting as an agent, not providing billing for the physicians, avoiding financial arrangements with physicians, not allowing clothing or name tags worn by physician to state the hospital's name, and disclosing upon the patient's entrance to the emergency room that there are independent doctors available from which the patient can select.92 in churkey v. rustia, the plaintiff had signed an informed consent form provided by the hospital which stated that she understood the hospital used independently-contracted physicians to perform anesthesia and radiology services. 93 the form also stated that the "physicians are not employees" of the hospital.94 the court held that the physician was not an agent of the hospital and that the plaintiff presented no evidence that the hospital held the physician out as its agent.95 the court also stated that if the "patient knew or should have known that the defendant physician was an independent contractor, then the hospital is not liable."96 by informing the patient of the physician's inde­ pendent contractor status, the reliance aspect of ostensible authority was 91. see alaska stat. § 09.65.096(a) (michie 1997), which requires notice by the hospitals to avoid civil liability of emergency room physicians who are independent contractors. the notice requirement must meet the following criteria: "(1) be posted conspicuously in all admitting areas of the hospital; (2) consist of a sign at least two feet high and two feet wide, with print at least two inches high; (3) be published at least annually in a newspaper of general circulation in the area;" and (4) describes what language should be included and the physical form it should take. id. 92. terry 0. tottenham, suggestions to avoid finding ofvicarious liability/ostensible agency, 1 healthl. prac. guide§ 9:32 (2002). see also porter v. sisters of st. mary, 756 f.2d 669, 670 (8th cir. 1985) (determining that the hospital was not liable under ostensible agency theory after reviewing a majority of the factors). 93. churkey v. rustia, 768 n.e.2d 842, 844 (ill. app. ct. 2002). 94. ld. 95. id. at 847. 96. id. at 845. 2004] drawing a fine line with informed consent 267 eliminated because the patient had knowledge that the physician was not an employee of the hospital. to the contrary, the south carolina supreme court, in simmons, noted that a hospital would "not be allowed to escape liability by giving last-minute notice of independent-contractor practitioners through admission forms or emergency room signs. "97 the court further reasoned that a hospital could be held liable under an agency theory or a nondelegable duty theory for negligent acts of emergency room physicians.98 all of the above-mentioned, assertive efforts to promote awareness of the physician's employment status would be better expended if they were used to improve patient care and safety. if patients are faced with a constant bar­ rage of advertising, information, or paperwork to sign concerning how the physicians are not employees of the hospital, patients may suspect that the hospital does not have confidence in the physicians' skills or that the hospital does not support or endorse the physicians working within its facility. on the other hand, one could argue that a hospital promoting the awareness of physi­ cians' employment status would actually be supplying patients with beneficial information that is relevant to their care and well-being. nevertheless, many patients are very ill or seriously injured (e.g., emer­ gency room patients) and come to the hospital for care, not a lecture on how the hospital wants to escape being held accountable for the negligent acts of the physicians working primarily within its walls. accordingly, it has been held that a patient is under no duty to inquire about the employment status of a physician when the patient seeks medical treatment from the hospital.99 patients are often not in a clear, cognitive state of mind when ill or seeking treatment and may not be able to absorb or decipher the information given to them regarding the physician's employment relationship with the hospital. patients do not need the extra burden of deciding what physician to choose when having a radiologic procedure, undergoing anesthesia, or entering an emergency room. actions based on the theory of ostensible agency have been successfully brought against hospitals for negligent acts of radiologists, anesthesiologists, pathologists, and even surgeons when the patient chose the physician because the physician was on the hospital staff. 100 the ostensible agency theory could be expanded to encompass the informed consent process for any procedure performed by the above-mentioned physicians and emergency room physi­ cians because courts have already included negligent acts under the theory. in today' s health care delivery system, the sacred relationship between a physician and his or her patient is more of an illusion than a reality. 97. simmons v. tuomey reg'l med. ctr., 533 s.e.2d 312, 320 (s.c. 2000). 98. ld. 99. grewe v. mount clemens gen. hosp., 273 n.w.2d 429, 432-35 (mich. 1978). 100. abraham & weiler, supra note 11, at 388. see also terry 0. tottenham, ostensible agency, 1 health l. prac. guide§ 9:30 (2002). 268 indiana health law review [vol. 1:253 "obtaining informed consent requires time for discussion. as physicians feel increased pressure to see more patients, particularly in the managed care setting, full disclosure and open discussion is less likely to occur."101 in the valles case, the informed consent procedure does not appear to create a relationship between the radiologist and the patient, let alone an individualized connection, as the court contends. the main reason the pennsylvania supreme court refused to extend liability to the hospital was not that the responsibility rested solely on the physician, but that informed consent was not within the scope of employment.102 the dissent in valles provided a very persuasive argument to the contrary. other jurisdictions may agree with the dissent and conclude that informed consent is an essential part of the radiologist's daily responsibilities; therefore, it is apparent that informed consent is within the scope of his or her employment. in many cases, the relationship between the patient and physician does not exist prior to the procedure. the procedures involving radiologists are an excellent example of this. "[t]he patient-radiologist relationship tends to be brief and episodic, so that radiologists may not feel comfortable discussing the risks and complications of their procedures with the patient."103 in addition, the radiologist may not be aware of the alternatives of treatment that are not radiologic in nature; therefore, he or she may not be able to adequately inform the patient. 104 the radiologist example defeats the argument set forth in kelly v. methodist, that ''by virtue of his relationship with the patient, the physician is in the best position to know the patient's medical history and to evaluate and explain the risks of a particular operation in light of the particular medical history. "105 the physician who orders a radiologic procedure is required to explain the other alternatives to the patient;106 however, the ordering physician may not know all of the risks associated with the radiologic procedure and thus will not be able to adequately inform the patient about the procedure. despite any obligation on the ordering physician to provide alternatives or information to his or her patient, the legal responsibility of informed consent has traditionally been placed on the radiologist's shoulders. because the radiologist is primar­ ily responsible for obtaining informed consent, the individualized relationship noted in valles often does not exist, especially when a patient does not select the physician performing the procedure (e.g., a radiologist, anesthesiologist, or emergency room physician). 101. barry r. furrow et al., supra note 33, at 340. 102. valles v. alberteinsteinmed. ctr., 805 a2d 1232,1239 (pa. 2002). 103. reuter, supra note 79, at 219. 104. id. at 224. 105. kelly v. methodist hosp., 664 a.2d 148, 151 (pa. super. ct. 1995). 106. "[a] doctor recommending a particular procedure generally has, among other obligations, the duty to disclose to the patient all material risks involved in the procedure." pauscher v. iowa methodist med. ctr., 408 n.w.2d 355, 358 (iowa 1987). 2004] dra wlng a fine line w111i informed consent 269 in addition, physicians are not the only individuals performing proce­ dures which require informed consent. hospital personnel (e.g., nurses, er techs, radiologic technologists, and other medical professionals) are also obtaining informed consent. a hospital may be held liable for the negligent acts of its employees under the theory of respondeat superior. 107 less inquiry is required into the hospital's role in an employee's negligent act compared to its role in an independent physician's negligent act. in either case, hospitals need to be aware of the potential liability that may result from involvement in the informed consent procedure. iv. voluntary assumption of duty by increments of control hospitals are taking on more responsibility and exerting more control over patient care than they have in the past. government funded regulations, the structure of health care networks, and the proliferation of medical malpractice litigation have led to less autonomy of the physician and an increase in control of patient care by the hospital. 108 along with this increase in control, hospitals' liability has expanded for negligent acts of their physi­ cians.109 this new acquisition of control can be depicted as an assumption of duty. under tort law, "a defendant may voluntarily assume a duty by affrrma­ tive conduct which would not exist in the absence of such conduct."110 by exerting some control over the informed consent process, hospitals could be characterized as assuming a duty to properly inform patients prior to procedures. one aspect of control, although minimal, is the promulgation of policies and procedures for informed consent. adopting policies and proce­ dures alone will not generally create hospital accountability. in kelly, the superior court of pennsylvania rejected appellant's claim that the hospital's adoption of a policy requiring physicians to obtain informed consent was a voluntary assumption of duty to ensure informed consent occurred.111 the court reasoned, "it is highly unlikely the hospital, in adopting its rule requiring that a written consent form be signed, intended to assume a duty greater than that imposed by law."112 the court also noted, "it was not intended to shift the burden of obtaining informed consent from the physician 107. see robin frye bond, respondeat superior, 1 health l. prac. guide§ 1:4 (2002). liability will be imposed on the "healthcare provider for acts of its employees that are committed while performing within the scope of their employment." ld. 108. see linda b. johnston, playing doctor: who controls the practice of medicine?, 66 st. john's l. rev. 425, 429-30, 441 (1992). control is witnessed through employee­ structured health plans, increased decision making in order to avoid litigation, and compliance with federal and state regulatory schemes. /d. 109. !d. 110. stephanie a. giggetts, voluntary assumption of duty, 1 summary pa. jur. 2d torts § 2:4 (2002). 111. kelly v. methodist hosp., 664 a.2d 148, 151 (pa. super. ct. 1995). 112. id. 270 indiana health law review [vol. 1:253 to the hospital nor does it obligate the hospital to guarantee a patient tenders informed consent. " 113 however, the decision was based on a battery theory for informed consent, 114 and one has to contemplate whether the court would have reached the same result if pennsylvania had adopted a negligence standard for informed consent, as the majority of states have done. similarly, the supreme judicial court of maine refused to recognize the theory of corporate liability in a cause of action against a hospital for failing to enact regulations or policies that controlled the actions of independent physicians.115 the court stated, ''there exist serious and unanswered public policy questions regarding the wisdom of requiring hospitals to control the medical judgments and actions of independent physicians practicing within their facilities."116 the court mentioned public policy inquiries of patient safety, quality of care, welfare of the public, and economic considerations.117 even though formulating policies and procedures alone are ordinarily not enough to impose liability, doing so may become a factor in evaluating the amount of control a hospital exerts toward informed consent. "a hospital has a duty to its patients to use reasonable care in formulating the policies, procedures, rules, bylaws, etc., by which its medical staff and nonphysician personnel will be govemed."118 "some courts have recognized a duty to use due care in enforcing such policies and procedures and in ensuring that they are not violated."119 a hospital can be liable for a breach of either of the above duties if it is the proximate cause of the patient's injury.120 hospitals have been held liable for failing to enforce policies, failing to implement proper policies, and for enacting deficient protocols. the oregon court of appeals imposed liability on a hospital for the omission of a policy or protocol governing verification of a central line placement when a patient was transferred from the operating room to the post anesthesia care unit (pacu).121 the hospital had a written nursing policy regarding non-urgent line placement outside the surgical area. the policy contained information stating that only credentialed physicians can insert a central line and that a chest x-ray is required for line verification. 113. id. 114. id. at 150. 115. gafner v. down e. cmty. hosp., 735 a.2d 969, 979 (me. 1999). 116. id. at 980. 117. i d. at 978, 980. 118. terry 0. tottenbam, negligence in the formulation and enforcertll!nt of policies, procedures, and rules, 1 health l. prac. guide § 9:36 (2002). 119. id. hospitals can be sued under the corporate negligence theory for failing to "for­ mulate, adopt, and enforce adequate rules and policies to ensure quality care for the patients." thompson v. nason hosp., 591 a.2d 703, 707 (pa. 1991 ); accord corrigan v. methodist hosp., 158 f.r.d. 70, 73 (e.d. pa. 1994). 120. tottenham, supra note 118. 121. jennison v. providence st. vincent med. ctr., 25 p.3d 358, 363 (or. ct. app. 2001). 2004] drawing a fine line with informed consent 271 however, the hospital did not have a written or oral policy regarding the course of action that is to be taken once the x-ray is reviewed by a radiologist.122 the clinical imaging manager conceded in her testimony that in relaying the results of a chest x-ray, the radiologist could potentially call up to five different people with the central line placement results and no written documentation was mandated once someone received the telephone call from the radiologist. 123 thus, the results may have never reached the inquiring physician and were not documented anywhere. the lack of a policy to control what happened after the central line verification was negligence on behalf of the hospital. 124 similarly, the pennsylvania superior court reasoned that hospitals could be held accountable for establishing deficient standards.125 the court stated, "if the hospital itself (through its official committee on infection control) adopts a substandard rule for changing intravenous catheter sites, then it may be liable in its corporate capacity."126 a. assertion of control by compliance with jcaho standards the majority of hospitals formulate policies and procedures pursuant to jcaho guidelines. jcaho is a voluntary independent accrediting body for hospitals; however, accreditation by jcaho is required for medicare and medicaid reimbursement and recognition under most state licensing requirements.127 jcaho has been considered evidence of the standard of care by many courts in determining whether a hospital has been negligent. 128 the 122. i d. the policy only mandated the verification of the line placement. 123. i d. the radiologist could have called the results to the patient's nurse, patient's sur­ geon, a resident assisting the surgeon (if applicable), anesthesiologist, or the floor (p acu). i d. arguably, an acceptable policy would designate one person or position that would always receive the call and be responsible for documentation of the results in a specified area of the chart. 124. ld. 125. edwards v. brandywine hosp., 652 a.2d 1382, 1388 (pa. super. ct. 1995). 126. ld. at 1388. 127. see craig w. dallon, understanding judicial review of hospitals' physician creden­ tialing and peer review decisions, 73 temp. l. rev. 597, 603 (2000); barry r. furrow et al., the law of healthcare organization and finance 155-59 (4th ed. 2001 ). "jcaho was organized in 1952 by the american medical association, the american college of physicians, and the american hospital association." rutchik, supra note l, at 556. the two main goals of jcaho are "to improve overall patient care and to establish minimum standards that hospitals must follow to receive accreditation." ld. "the joint commission develops all its standards in consultation with health care experts, providers, measurement experts, pur­ chasers, and consumers. standards are generally updated every two years and change only to improve clarity or reduce duplication." joint comm'n on accreditation of health care orgs.,athttp://www.jcaho.org/accredited+organizationslhospitals/standards/standards.htm(last visited nov. 21, 2003). 128. bales & demarco, supra note 22, at 493. see also penn tanker co. v. united states, 310 f. supp. 613,618 (s.d. tex. 1970) (finding the hospital liable for negligence in failing to 272 indiana health law revjew [vol. 1:253 failure to comply with such standards is not negligence per se, but may be evidence of negligence on behalf of the hospital.129 jcaho guidelines can also be reviewed along with institutional protocols to determine a hospital's duty to its patientsy0 jcaho has established standards for informed consent. the standard set forth is, "before obtaining informed consent, the risks, benefits, and potential complications associated with procedures are discussed with the patient and family." tx.5.2.1 adds, "alternative options are considered."m the intent of these standards is that "[p ]atients receive adequate information to participate in care decisions and provide informed consent."132 jcaho provides examples of evidence of administering these standards, including interviews with patients, interviews with clinical staff, informed consent policies, and documentation in medical records.133 by adhering to the jcaho standards, the hospital has exerted some control (even though it may be depicted as minor) over the informed consent process. the hospital's compliance with and enforcement of jcaho standards may be viewed by courts as voluntarily assuming a duty to ensure patients are informed prior to procedures. b. another element of control-informed consent forms hospitals are interjecting a control element into the informed consent procedure by creating consent forms to be used by physicians and hospital personnel. a recent study concerning informed consent forms was published in the archives ofsurgery.134 the study involved an analysis of 540 informed enforce policy that had been enacted pursuant to jcaho standards). 129. bales & demarco, supra note 22, at 496. courts have treated the issue of liability pursuant to jcaho standards inconsistently. in pedroza v. bryant, 677 p.2d 166, 171 (wash. 1984), the washington supreme court stated that the hospital's standard of care is established by jcaho standards and the institution's bylaws adopted pursuant to those standards. in con­ trast, the superior court of california, in gonzales v. nork, 131 cal. rptr. 717, 718 (cal. app. 1976), reasoned that the jcaho standards were vague and not enough to insulate the hospital from liability (not used as a standard of care). rutchik, supra note 1, at 562-63. 130. bales & demarco, supra note 22, at 496. 131. jointcomm'nonaccreditationofhosp.&healthcareorgs.,comprehensive accreditationmanualforhospitals 94, tx-37 (2001). 132. id. 133. jd. 134. melissa a. bottrell et al., hospitallnformed consent for procedure forms: facilitat­ ing quality patient-physician interaction, 135 archives surgery 26, 26-33 (2000). the study focused on three objectives: [t]o determine the purpose of and what information is included in informed consent for procedure forms; to examine the extent to which the forms meet accepted medical, ethical, and legal standards; and to explore whether existing forms are capable of enhancing interactions between patients and physicians or other health care providers. /d. at27. 2004] drawing a fine line wli'h informed consbnt 273 consent forms from 157 hospitals nationwide.135 out of all of the forms, 62.9% were for specific purposes, 32.9% were general forms, and 4.2% were used for a series of procedures or were not classified. 136 the authors' conclusion was that the majority of the consent forms did not meet accepted standards (i.e., statutes, jcaho standards; and commonly accepted professional standards) of informed consent or patient-physician interactions.137 ideally, well-designed forms should "foster the use and reten­ tion of meaningful information and enhance the quality of patient-physician interactions,"138 thus benefiting patient care. in order to avoid liability, con­ sent forms should contain the following minimum content elements: (1) the nature of the procedure, (2) the risks involved, (3) the benefits of procedure, and (4) the altematives.139 informed consent forms can be advantageous because they "provide valuable information to which the patient can refer, they provide information about some specific set of risks and benefits, and they provide concrete evidence that some information was transmitted to, and some assent obtained from, the patient."140 on the other hand, forms are ''frequently written in great detail and use medical and legal terminology far beyond the capacity of many patients."141 thus, the forms can be a hindrance to the informed consent procedure. hospitals developing forms need to be mindful of the terminology used and what information needs to be conveyed for a specific procedure. by creating forms, hospitals may greatly benefit patient care, but in the process, they are exerting a control element into the informed consent procedure. development of forms may add weight to the liability theory of voluntary assumption of duty on behalf of the hospital. as technology advances, informed consent forms may be replaced by computerized interactive devices, such as cd-roms or computer based training modules that explain a procedure, provide possible alternatives and risks, and then attain the patient's understanding of the information pro­ vided.142 computerized devices would have to be installed by the hospital and physicians, working solely within the hospital, would use these devices to inform their patients about procedures. in this future scenario, a hospital would be the main source of informed consent-by developing or purchasing these electronic devices and installing them within the hospital network system. hence, the already atrophying physician-patient relationship would 135. id. at 26. 136. id. at 28. 137. id. at 26. 138. id. at27. 139. bottrell et al., supra note 134, at 26. 140. loismargaretnora&robertj. benvenuti, iu,medicdlegalaspectsoflnformedcon­ sent, 16neurologicalci.jnicsn.am. 207,211 (1998). 141. ld. 142. see generally arnold j. rosoff, informed consent in the electronic age, 2s am. ll. &med. 367 (1999). 274 indiana health law review [vol. 1:253 be almost nonexistent. this future vision, however, may contribute to better patient protection and better choices by the patient, thus positively affecting the quality of patient care and decreasing the potential for malpractice claims. hospitals also have a due diligence duty to avoid causing harm. 143 a hospital can breach this duty ''by any legally harmful act or omission which might have been foreseen and avoided, especially when the person injured is one for whose safety and protection the defendant was at the time under some special obligation to act with due foresight."144 by hospitals becoming involved in the informed consent process through jcaho standards, policies and procedures, promulgation of forms, or future computerized devices, it is foreseeable that a person could be injured by negligent acts of a physician, working primarily within the walls of the hospital, during the informed consent procedure. v. appearance as a patient care provider through advertising and marketing today, hospitals are holding themselves out as patient care providers. the darling court, in 1965, abandoned charitable immunity and adopted corporate liability for hospitals, noting that hospitals "do far more than furnish facilities for treatment."145 the court reasoned that hospitals employ large staffs, including physicians, nurses, interns, administration, and manual workers, in addition to charging patients for care and taking legal action to collect upon outstanding debts. 146 the hospital's larger function is even more apparent today. "as an industry, hospitals spend enormous amounts of money advertising in an effort to compete with each other for the health care dollar, thereby inducing the public to rely on them in their time of medical need. "147 the public is neither interested in nor cognizant of all the technical complexities involved with contracting and employment relationships between the medical professionals and the hospital. 148 143. stephanie a. giggetts, duty to use due diligence to avoid causing harm, 1 sum­ mary pa. jur. 2d torts§ 2:7 (2003). 144. ld. 145. darling v. charleston cmty. hosp., 211 n.e.2d 253, 257 (lll. 1965). see also supra note 12 and accompanying text. the simmons court provided an explanation for the alterations in the hospital's role of patient care: "among the many forces that have caused this ... change are the commercialization of the practice of medicine, the public's demand for access to modem medical technology, the prevalence and impact of government-funded programs such as medicare and medicaid, and the rise of managed care in the private sector." simmons v. thomey reg'l med. ctr., 533 s.e.2d 312, 317 (s.c. 2000). 146. darling, 211 n.e.2d at 257. 147. clark v. southview hosp. & family health ctr., 628 n.e.2d 46, 53 (ohio 1994). 148. ld. 2004] drawing a fine line wrm informed consent 275 justice waller, writing for the majority in simmons, described the modem hospital agenda as follows: today, hospitals compete aggressively in providing the latest medical technology and the best facilities, as well as in attracting patients and physicians who will funnel patients to them . . . . like any business dependent upon attracting indi­ vidual people as customers, hospitals in the aggregate spend billions to advertise their facilities and services in a variety of media, from newspapers and billboards to television and the internet. 149 advertising and marketing campaigns have significant effects on a patient's reliance on a health care provider. in clark v. southview, the supreme court of ohio concluded that through its advertising and marketing, the hospital held itself out as having the "latest technology and equipment" and as being able to "handle all major medical emergencies."150 the plaintiff demonstrated reliance through her pre-emergency request to go to the defendant hospital in the event of an emergency, which required her to travel a farther distance than if she had chosen another hospital.151 a hospital's marketing and advertising of technology and physicians impacts the way patients make their medical decisions. by using such mar­ keting techniques, hospitals are endorsing the physicians that are associated with the hospital. patients who look to the hospital in order to select a physician, such as a radiologist, anesthesiologist, emergency room physician, and occasionally a surgeon, trust the hospital's judgment of its physicians. accordingly, in bing v. thunig, the high court of new york reasoned, ''cer­ tainly, the person who avails himself of 'hospital facilities' expects that the hospital will attempt to cure him, not that it [sic] nurses or other employees will act on their own responsibility."152 the public's increased reliance on the hospital leads to the greater likeli­ hood of liability.153 reliance may be viewed as a form of dependency. a relationship that is characterized as involving dependency and disparity of power gives way to a fiduciary obligation or responsibility. 154 these relation­ ships ''require heightened standards of good faith, honesty, and trust on the part of the fiduciary."155 hospitals may be viewed by the courts as establish149. simmons. 533 s.e.2d at 316-17. 150. clark, 628 n.e.2d at 46. 151. id. at 54 n.1, 55. 152. bing v. thunig, 143 n.e.2d 3, 8 (n.y. 1957). 153. see pedroza v. bryant, 677 p.2d 166, 169 (wash. 1984). 154. richard a. heinemann, pushing the limits of informed consent: johnson v. koke­ moor and physician-specific disclosure, 1997 wis. l. rev. 1079, 1090. 155. id. 276 indianahbalm law review [vol. 1:253 ing fiduciary relationships with patients who come to the hospital for medical treatment and tnist that the hospital will cure them. public policy plays an important role in the accountability of heath care actors and entities: "public policy dictates that the public has every right to assume and expect that the hospital is the medical provider it purports to be."156 the image of the hospital as protecting the public has shifted to a business-like image largely because the hospital is a profit making corporation, whi~h has its own interests in mind. "ff]he basis of hospital liability analysis was once that protecting the hospital benefitted [sic] the public as a whole, the focus is shifting to the expectations of the public and the individual patient, who is .to be protected at the hospital's expense."m commentators contend .that public policy necessitates accountability on the hospital's distributive role as edging closer to a strict liability theory.158 why should informed consent be treated differently than other medical malpractice actions involving a physician and a hospital? under the doctrine of corporate liability, hospitals have a duty to supervise physicians and pro. mulgate policies and procedures-both are involved in the procedure of in­ formed consent. the sacred physician-patient relationship in valles is rarely present with the physicians who work primarily within the walls of the hospital, and the main goals of informed consent, patient autonomy, and self­ determination may actually be better protected if the hospital plays a role in the informed consent procedure. 159 imposing the duty of informed consent on a hospital can be viewed as advantageous in several ways. first, the hospital is the logical nexus for ensuring that informed consent is obtained from a patient. some physicians are unwilling to acquire a patient's informed consent in the hospital setting, and the hospital will now have the incentive to pursue informed consent.160 second, the current trend in other areas of the law is that courts are more willing to find that hospitals have increased obligations to supervise staff, hire competent personnel, and to create appropriate policies and procedures 156. clark, 628 n.e.2d at 53. 157. martin c. mcwilliams, jr. & hamilton e. russell, m, hospital liability for torts of independent contractor physicians, 41 s.c. l. rev. 431, 473 (1996). 158. id. 159. with the recent emphasis on medical errors eradication and patient safety throughout the country, a hospital's role in checking or evaluating the infonned consent process undertaken by physicians, who are agents of the hospital, will improve patient care and ensure physicians are properly informing patients. for information on the 2003 national patient safety goals, see http://www.jcaho.org/accredited+organizations/patient+safetylnpsg.htm (last visited oct. 24, 2003). see also doing what counl$ for patient safety: federal actions to reduce medical errors and their impact, at www.healthsafetyinfo.com/pdf/errors.pdf (last visited nov. 21, 2003). 160. furrow et al, supra note 33, at 339. historically, as medicine has advanced, physicians have become more and more dependent on hospitals for the diagnostic. and therapeutic services that only they can provide. see dallon, supra note 127, at 601. 2004] drawing a fine line wli'h informed consent 277 regarding patient care. 161 third, courts are becoming less deferential to physi­ cians because delivery of health care is viewed more as a team concept and hospitals are vital support in the care of a patient.162 lastly, the hospital and its administration have the responsibility to ensure completeness of records for reimbursement and monitoring of health care. written consent forms aid in the completeness of records even though some may contend the forms only provide "bureaucratic formality."163 it has been asserted that the hospital is in the "best position to monitor conduct within its walls, to enforce adherence to policies, and to provide a source of compensation to injured patients."164 if hospitals eventually become susceptible for the failed informed con­ sent of the physicians whose work is conducted virtually exclusively' within its walls, both healthcare costs and patient care could be affected. if hospitals do not plan accordingly to insulate themselves from liability, the costs of litigation would most likely be passed on· to' the patients.165 accordingly, justice flaherty, in thompson, was concerned about costs and proclaimed the corporate liability doctrine (establishing a direct duty owed by the hospital to the patient) was a "deep pocket theory of liability, placing financial burdens upon hospitals for the actions of persons who are not even their· own employees."166 · it has been noted, however, that informed decision tiwdng actually could improve health care cost containment because a more informed patient may choose the less expensive procedure.167 patients today realize the finan­ cial incentives and pressures involved in providing health care. in addition, patients have many niore resources today to educate themselves about different procedures and alternatives. vl. conclusion today's hospital is a health care provider and cannot hold itself out as a multi-service facility providing any and all care a patient may need without eventually assuming all of the responsibilities and risks that come along with offering this type of service. the dynamic physician-patient relationship is 161. furrow et al., supra note 33, at 339. 162. /d. 163. /d. 164. /d. at 381. 165. with the rising healthcarecosts at issue, president george w. bush called for medical liability reform in january of 2003. the president reasoned that there are too many frivolous lawsuits brought against hospitals and physicians. the president proposed malpractice "caps" on non-economic and punitive damages, in addition to the implementation of joint and several liability on the medical liability system. president calls for medical liability reform, at http:// www.whitehouse.gov/newslreleasesl2003101/20030116-l.html (last visited oct. 24, 2003). 166. thompson v. nason hosp., 591 a.2d 703, 709 (pa. 1991). 167. joan h. krause, reconceptualizing informed consent in an era of health care cost containment, 85 iowal. rev. 261, 363 (1999). 278 indiana heal'ih law review [vol. 1:253 not as individualized as it has been in the past, and if theories of non-delegable duty, agency, corporate liability or voluntary assumption of duty are extended, the hospital may find itself in a position of accountability for the informed consent procedure. in order to decrease potential liability and increase quality of care, hospitals must proactively collaborate with physicians, who work primarily within such facilities, to develop a better system of obtaining informed con­ sent. additionally, hospitals should ensure that physicians are current on education and new information affecting their specialty fields and require hospital personnel to understand their role in the informed consent procedure. thus, through the efforts of the hospital, communication will improve between everyone involved, the risk of liability will decrease, and ultimately patient care will be enhanced. the awful taste of partially hydrogenated vegetable on.: a recommendation that indiana ban trans fats from restaurants andrew j. vanlandingham· i. introduction ............................................................................... 326 ii. why can't i just have my partially hydrogenated vegetable oil fried french fries in peace? ......................... 329 a. what are trans fats? .............................................................. 329 b. why are trans fats bad? ........................................................ 330 i. physiological effects on the body ..................................... 330 2. the unknown danger ........................................................ 331 ill. removing trans fats from .america's diet .......................... 332 a. indiana's current approach to trans fat ............................... 333 i trans fat legislation ........................................................ 333 2. movements promoting a healthy lifestyle in indiana ......... 334 b. new york city's ban on trans fats ......................................... 335 i. voluntarily removal oftrans fats fails in new york city .................................................................................... 336 2. the shift to a mandatory ban on trans fats .................... 337 3. but, is it working? ............................................................. 338 iv. government authority and its limits ................................... 338 a. indiana's authority to regulate food establishments ............. 340 1. curtice bros. co. v. barnard ............................................. 341 2. albert v. milk control bd ................................................. 342 b. commerce clause limitations ................................................. 343 i. dormant commerce clause limitations ........................... 344 2. the fda has not preempted state and local government bans on trans fats ....................................................................... 348 v. recommendation that indiana removes trans fats from restaurants ................................................................................ 349 a. public health regulatory options ........................................... 349 i. taxing is not the answer .................................................... 350 2. altering physical and socio-economic environments is too costly and does not directly address the problem of trans fats ..................................................................................... 351 3. litigation against restaurants would not be effective ....... 351 b. indiana's solution to trans fat ............................................... 352 i. why use direct regulation? ................................................ 353 * j.d. candidate, 2009, indiana university school oflawindianapolis; b.a., 2006, wabash college. · 326 indiana realm law revmw [vol. 6:325 2. the trans fat ban should be closely modeled after new york city's ban .......................................................................... 354 vi. conclusion .................................................................................. 355 i. intr.oduciton one of the primary functions of federal and state government is to protect its citizenry. in the short span of a couple of months in 2008, the food and drug administration ("fda") hunted down potential food crops that may have caused an outbreak of salmonella, 1 congress passed amendments to the foreign intelligence service act to help prevent a terrorist attack on american soil/ and municipal government in los angeles enacted a one-year moratorium on fast­ food restaurants in impoverished areas of its city.3 government responds to problems of all kinds, using broad police powers to validate action in the name of public safety. 4 often times, government response is more substantial when the. public's health is put in immediate risk.5 an immediate and severe threat to our health gives government the broadest rationale for action.6 yet, if a threat to public health is less immediate and more obscure, resis­ tance to government action is much greater. why should government hesitate to prevent risks that pose long-term threats to health? with emerging chronic disease epidemics, the inflation of health care costs, the desire to ensure the health and future of america's children, and providing healthier choices for america's food supply, the indiana general assembly should ban trans-isomer fatty acids (''trans fats") from all indiana restaurants to ensure the long-term public health of its constituents. undoubtedly, critics of a trans fat ban will argue that this form of public health legislation is a paternalistic or ''nanny­ state" style of governance. to counter this argument, proponents of a trans fat ban must make a doubled-sided argument that is internally inconsistent. that is, proponents must highlight that removing trans fats from restaurants will pro­ vide a crucial public health benefit, while simultaneously emphasizing that 1. annys shin, all tomatoes cleared of salmonella risk, officials say, wash. post, july 18, 2008, at do 1. 2. dan eggen and paul kane, surveillance bill offers protection to telecom firms, wash. post, june 20,2008, ataol. 3. lisa baertiein, los angeles city council passes fast-food ban, reurers, july 30, 2008, available at http://www.reuters.com/articlelhealthnews/iduscol06846020080730. 4. see generally edward p. richards, public health law as adminhltrative law: exam­ ple lessons, 10 j. health carel. & pol'y 61, 64 (2007). 5. see generally michael greenberger, the alfonse and gaston of governmental re­ sponse to national public health emergencies: lessons learned from hurricane katrina for the federal government and the states, 58 admin. l. rev. 611 (2006) (discussing the need for administrative procedure to improve coordination between federal and state governments during disasters). 6. id. 2009] awful taste of partially hydrogenated oil 327 most hoosiers will not notice that trans fat has been removed from their favorite restaurant foods. the latter argument highlights the difficulty of passing public health legis­ lation. if the government begins to regulate something that is seemingly ob­ scure and benign, such as trans fats in restaurant food, critics will react with speculation and claim that there is too much government paternalism interfering with the free market.7 a trans fat ban conjures the image of uncle sam swat­ ting the hand of a restaurant patron from that "oh-so-dangerous" french fry. this hypothetical imagery is an absurd scenario that nearly every american would reject. the question, however, remains: what role should the government play when it comes to regulating the nation's diet? on one hand, there is an epidem­ ic of chronic disease ravaging the country. 8 diabetes, heart disease, and even some cancers are more prevalent now than ever before.9 in addition to an un­ healthier population, chronic disease is also burning a hole through american pocketbooks. the nation's weight problem causes "an estimated $69 billion to $117 billion" to be spent every year in obesity-related health problems. 10 on the other hat1d, there is fear that government regulation controlling what restau­ rants can serve will eventually lead to regulations that may control every aspect of an individual's diet, effectively eliminating free choice.11 banning trans fats from restaurants, however, does not remove an existing choice granted to restaurant patrons. generally, consumers cannot choose to avoid trans fats when eating at a restaurant mainly because restaurants are not statutorily required to post nutritional information. thus, consumers are not privy to important ingredient information when selecting meals. recently, however, several cities and states have tried enacting laws that require restau­ rants to display nutritional information in menus. 12 outside of those legislative 7. rogers. magnusson, mapping the scope and opportunities for public health law in liberal democracies, 35 j.l. med & etiiics 571, 576 (2007). 8. see, e.g., nat'l ctr. for health statistics, dep't of health and human services, publ 'n no. 2007-1232, health, united states 3 (2007), available at http://www.cdc.gov/nchs/data/hus/hus07.pdf("[i]ncreased longevity is accompanied by increased prevalence of chronic conditions and their associated pain and disability."). 9. !d. ("of concern for all americans is the high prevalence of people with unhealthy lifestyles and behaviors, such as insufficient exercise and overweight, which are risk factors for many chronic diseases and disabilities including heart disease, diabetes, hypertension, and back pain."). 10. sarah taylor roller, theodore voorhees, jr. & ashley k. lunkenheimer, obesity, food marketing and consumer litigation: threat or opportunity, 61 food & drug l.j. 419, 419 (2006). 11. see nat'lrestaurant ass'n., 2007 state legislative session summary 5 (2007), available at http://www.restaurant.org/pdfs/govemment'07 _state _legislative_ summary.pdf ("the [national restaurant association] believes that if activists succeed in imposing trans-fat bans, they'll press for regulation of sodium and other ingredients. the center for science in the public interest has already talked about increased regulation for other foods and beverages, in­ cluding wine, beer, soda, milk. coffee, sugar, artificial sweeteners, salt, oils and fats, olestra, poultry, meats and cheese."). 12. i d. at 4. (identifying all states and cities that have proposed, enacted, or have pending 328 indiana health law review [vol. 6:325 attempts, a patron generally must go to great lengths to determine whether they are eating trans fats. typically, consumers are denied easy access to important nutritional information when eating at restaurants, and are therefore, ipso facto, denied choice. as more americans eat outside of the home, it is a likely conse­ quence that more trans fats will continue to be consumed, but not because con­ sumers choose to do so.13 at home, americans do have a choice. in 2003, the food and drug administration ("fda") amended its nutritional labeling re­ quirements by mandating the disclosure of trans fat content on food labels. 14 consumers can now choose whether they want to purchase food that contains trans fat because the information is readily available. the result is a large con­ trol-gap between the ability to avoid trans fats at home (via mandated disclo­ sure) and the inability to avoid trans fats while eating in a restaurant. in light of the hann:ful consequences of trans fats and the appropriate re­ medial measures discussed above, this note will examine the proper role gov­ ernment should take to curb consumption ofharmful trans fats by the american population, with a specific focus on indiana state government. part it of this note will discuss what trans fats are, how they entered into americas' diet, and their adverse effects on the health of those who consume them. part ill will examine how various levels of government are regulating trans fats, with a close examination in part ill( a) on indiana's current approach to trans fats and new york city's recent ban on trans fats. part iv will examine the authority and limitations of government when regulating public health, including an analysis of indiana food regulation cases and an analysis of potential commerce clause problems. part v will examine the various governmental strategies to improve public health and proffer a conclusion as to which method is most per­ suasive for regulation of trans fats. lastly, with respect to indiana, this note will conclude with the suggestion that the state adopt legislation banning trans fats from all restaurants in indiana. menu labeling legislation as of september 12, 2007). see also ray rivera, bottle over calorie­ posting may widen, n.y. times, sept. 13,2007, available at http://www.nytimes.com/2007/ 09/13/nyregion/13calories.html. 13. econ.researchserv.,agric.info.builei'inno. 749,away-from-home-foods increasingly important to quality of american diet 1 (1999), available at http:/lwww.ers.usda.gov/publications/aib749/&b749.pdf("overthe past decades, eating out has been increasingly popular for americans. in 1970, 26 percent of total food expenditure was spent away from home; by 1996, that number bad risen to 39 percent"). 14. food and drug admin., fda acts to provide beiter information to consumers on trans fats l (2003), http://www.fda.gov/oc/initiatives/transfat/ (last visited nov. 8, 2007) (estimating the mandatory requirement will prevent "600 to l ,200 cases of coro­ nary heart disease and 250 to 500 deaths each year'' within three years of the enforcement date, [jan. 1, 2006]."). 2009] awful taste of partially hydrogenated oil 329 ll. why can't i just ha vb my partially hydrogenated vegetable oil fried french fries in peace? a. what are trans fats? trans fat is the common moniker used to refer to a type ''unsaturated fatty acids with at least one double bond in the trans configuration."15 most of these fatty acids "are formed during the partial hydrogenation of vegetable oils, a process that converts vegetable oils into semisolid fats for use in margarines, commercial cooking, and manufacturing processes."16 some trans fats occur naturally "in meats and dairy products from cows, sheep, and other ruminants; these trans fats are produced by the action of bacteria in the ruminant sto­ mach."17 data on the health effects of consuming these natural trans fats are limited. consequently, the health effects of natural trans fats consumption re­ main relatively unknown when compared to artificial trans fats, 18 -the majority of trans fat intake in food prepared in or with hydrogenated vegetable oil.19 on the molecular level, trans fatty acids are close cousins of saturated fat­ ty acids. 20 trans fatty acids derive their name from the double hydrogen bond that exists on the 18-carbon bond chain.21 the hydrogen bond exists on oppo­ site sides of the chain and cause the typical fatty acid to straighten out and be­ come more rigid. 22 the strong structure of a trans hydrogen bond provides a large amount of stability to the molecule; therefore, the fatty acids are less likely to break down when put under stress,such as heating. 23 thus, trans fatty acids are used in restaurants because they ''have a long shelflife, their stability during deep-frying, and their semisolidity [sic] which can be customized to enhance the palatability of baked good and sweets . ..24 in restaurants it is common to "cook and fry with partially hydrogenated oils. trans fat is [also] found in many pre-fried, baked, and prepared foods served in restaurants. "25 pre-fried foods are especially common in restaurants 1 s. dariush mozaffarian, martijn b. katon. alberto ascherio, meir j. stampfer & walter c. willet, trans fatty acids and cardiovascular disease, 354 new eng. j. mbd. 1601, 1601 (2006). 16. id. 17. id. 18. id. at 1609 ("[t)he sum of the current evidence suggests that the public health impli­ cations of consuming trans fats from ruminant products are relatively limited."). 19. id at 1601 (highlighting that two to three percent of calories consumed in the ameri­ can diet come from "industrially produced trans fatty acids" compared to a mere half percent of trans fatty acids consumed from natural origins). 20. see rozenn n. lemaitre et al., cell membrane trans-fatty acids and the risk of primary cardiac arrest, 1 os circulation 697, 697 (2002). 21. mozaffarian, supra note 15, at 1601. 22. id at 1602. 23. robert eckel et al., understanding the complexity oftrans fatty acid reduction in the american diet, 115 circulation 2231, 2233 (2007). 24. mozaffarian, supra note 15, at 1601. 25. n.y.c dbp't of hballliand mbntalhyoibnb, does your krrcm!nnbbd an on. 330 indiana health law review [vol. 6:325 because they reduce cooking time significantly. it is no wonder, then, that these pre-fried foods also happen to be staples of the american diet, "such as french fries, fried chicken, chicken nuggets, fish fillets, chips, taco shells, and doughnuts."26 most baked goods also contain high levels of trans fats due to the amount of shortening and margarine used in their production.27 b. why are trans fats bad? when trans fats first hit the market in 1911, the nutritional impact was unknown.28 it was not until the 1990's that researchers began to understand the effect of trans fats on the body.29 now, more studies are being released on a consistent basis that adds to the growing list of illnesses that trans fats are linked to and/or cause. 30 unfortunately, because the effects of trans fats are just now being discovered, the public remains confused about the actual danger of trans fats and how to reduce trans fat consumption. 1. physiological effects on the body the major risk posed by trans fats is that they "raise low density lipoprote­ in (ldl or "bad") cholesterol in the blood. an elevated ldl cholesterol in­ creases the risk of developing coronary heart disease (chd). »lt trans fat also lowers "hdl-c [high-density lipoprotein or "good" cholesterol] and impair[s] fmd [flowed-mediated vasodilation]. this suggests that [trans fats] increase the risk of chd more than the intake of saturated fats, with similar effects on ldl cholesterol.'m this increased risk ofheart disease from trans fats has broad implications. change? 2 (2005), available at http:/lwww.nyc.gov/html/dobldownloads/pdf7cardio/cardio­ transtat-brochu.te.pdf [hereinafter does your. kltchbn need an oil chanoe?]. 26. id at 2. but see bantransfats.com, eateries news, http://www.bantransfats.com/ eateriesnews.html (last visited mar. 5, 2008) (listing all major restaurant chains that have announced the removal of or have already removed trans fats ftom their menus). 27. see nutrition sourcefats and cholesterol: out with the bad, in with the good, http://www.hsph.harvard.edulnutritionsourcelwhat-should-you-eat/fats-full-story/index.html (last visited sept 8, 2008) (some margarine has as much as 23% of its total fat contributed to trans fats and shortening can have nearly 18%). 28. eckel et al., supra note 23, at 2232. 29. id. (noting that in 1958 "researchers reported that within thecontextofa35% butter­ fat diet, there was no significant difference betwee.d. supplemental com oil and hydrogenated com oil."). 30. id. 31. fda and center for food safety & applied nutrition; questions and answers about trans fat nutrition labeling, http://www.cfsan.fda.gov/-dms/qatrans2.html#s4q 1 (last visited mar. 5, 2008). 32. nicole m. de roos, michiel l. dots & martijn b. k.atan, replacement of dietary saturated fatty acids by trans fatty acids luwers serum hdl cholesterol and impairs endo­ thelial function in healthy men and women, 21 arteriosclerosis, thrombosis, and vascular biology 1233, 1236 (july 2001), availoble at http://atvb.ahajoumals.org/cgi/content /full/21/7/1233 (explaining that consumption of trans fat decreased hdl-c, but could not de­ termine if the "impaired vasodilation was attributable to the decrease in hdl-c"). 2009] awful taste of partially hydrogenated oil 331 a medical review of several studies examining trans fat intake effects con­ cluded "a 2 percent increase in energy intake from trans fatty acids was asso­ ciated with a 23 percent increase in the incidence of chd [coronary heart disease]. "33 this data, when extrapolated across the general population, means "1 0 to 19 percent of chd events in the united states could be averted by re­ ducing the intake of trans fat. "34 yet another study provides evidence that con­ sumption of trans fats also increases the risk of primary cardiac arrest ("pca"). this population study showed that increased trans fat consumption was "asso­ ciated with a modest 1.5-fold increase in risk ofpca after adjustment for tradi­ tional risk factors."35 2. the unknown danger in may of 2003, san francisco lawyer, stephen joseph, responded to these heightened dangers, and filed suit against kraft/nabisco seeking an in­ junction to prevent the company from marketing its "oreo" cookie to california children until the cookies contained no trans fats. 36 his claim was based on the relatively little public knowledge of trans fats, and the dangers associated with their consumption: "[t]rans fat, is not commonly known to be unsafe ... [t]hat's why trans fat is a far stronger case than tobacco or mcdonald's because people know those are dangerous.'m joseph ultimately dropped the claim because the lawsuit had gained international attention, thus raising public awareness to the dangers of trans fats. 38 in response to this exposure, kraft/nabisco promised to rework the nutritional content of the oreo and have since created a trans-fat free oreo.39 despite similar suits, international media attention, governmental recom­ mendations and nutritional labeling, the general public still remains confused and uneducated about the dangers of trans fats. a recent study conducted by the international food information council revealed "[i]n general, fats are one of the more confusing labeling issues for consumers. ,.40 even though most con33. mozaffarian, supra note 15, at 1605. 34. id. at 1611 (stating that "[n]ear elimination of ... trans fats might avert between 72,000 (6 percent) and 228,000 (19 percent) chd events each year."). 35. lemaitre et al., supra note 20, at 699-700. 36. kim severson, lawsuit seeks to ban sale of oreos to children in california nabis­ co taken to task over trans fat's effects, s.f. chron., may 12,2003, at a3, available at http://www.sfgate.com/cgi-binlarticle.cgi?f=/c/a/2003/05/12/0reo.tmp. 37. id. 38. see kim severson, maker of oreos promises major nutritional overhaul, s.f. chron., july 2, 2003, at al, available at http://www.sfgate.com/cgibinlarticle.cgi?f=/c/a/2003/0 7 /02/0bese. tmp; see also carol ness, oreo is still king of the chocolate sandwich cookies, s.f. chron., june 21, 2006, at f2, available at http://www.sfgate.com/cgi­ binlarticle.cgi?f=/c/a/2006/06/21 /fdg lfjgak.vl.dtl. 39. id. 40. see international food information council, effective communication of dietary fats: an exploration of language 4 (2007), available at http://www.ific.org/research/upload!fats-language-report-final.pdf. 332 indiana heallh law review sumers could identify the fat information in nutritional labeling, to a certain degree, consumers mistrust the information about fats, particularly trans fats, that they are getting on food packages. some expressed skepticism about either the taste or health of foods made to be lower in fat con­ tent. others felt that excluding trans fat meant that other less than healthy fats were used in their place.41 [vol. 6:325 despite some mistrust in nutritional information on labels, "[ m )ost consumers indicated that they understand that saturated fats and trans fats are unhealthy.'.42 some consumers, however, still expressed confusion over why trans fat are unhealthy. one consumer stated, "trans fat i really don't understand. i under~ stand saturated fat, but i don 't understand why, now they're saying, 'oh now it's no trans fat, 'and you're eating ffast food], is what i just saw. and so i don't understand that. (chicago, female).',43 the american heart association performed a similar online study to measure consumer knowledge concerning trans fats, as well as their nutritional behaviors associated with trans fats.44 the survey found that nearly 84% of the respondents were aware of what trans fats were; "[h]owever[,] close to half of the respondents lacked understanding of the health effects of trans fats.'.45 the study also suggests that american eating habits at restaurants are already worse than at home: "[ c ]lose to half of the respondents reported 'never' or 'rarely' ordering a menu item marked as being 'healthy' in some way.'.46 ignorance of trans fat and its negative health effects only fuels the dangers associated with its consumption. but even knowing what trans fats are, and the health risks therein, consumers still lack the tools necessary to avoid the foods that contain them, especially in restaurants where no nutritional information is posted. not knowing how to avoid trans fats, combined with unhealthy eating habits associated with eating out, makes trans fats in restaurants particularly dangerous. iii. removing trans fats from america's diet late in 2006, new york city adopted a city-wide trans fat ban in all res41. id. at8. 42. id. at9. 43. id 44. see eckel, supra note 23, at 2232 (noting that the online survey was conducted "in the spring of2006 with a sample of 1000 adults 18 to 65 years of age."). 45. /d. {only 53% of respondents "answered 'increased risk ofheart disease' to the ques­ tion 'to the best of your knowledge, what effect, if any, do each of the following have on your risk of heart disease?'"). 46. id. at 2233. 2009] awful taste of partially hydrogenated oil 333 taurants,47 a policy shift that gained a large amount of media attention.48 since that highly publicized ban, numerous cities, counties, and states have proposed their own trans fat bans and several others have already passed laws modeled after new york city. 49 indiana has not yet followed the emerging trend of re,. gulating trans fats and is lagging behind in providing educational information regarding the harmful effects. a. indiana's current approach to trans fat 1. trans fat legislation currently, indiana has neither passed nor proposed legislation addressing trans fats in restaurants. the only current legislation that even mentions trans fats is indiana code 20-26-9, the school breakfast and lunch program regula­ tion: sec. 19: "food and beverage items sold to students; nu­ tritional values" (c) at least fifty percent (50%) of the food items availa­ ble for sale at a school or on school grounds must quali­ fy as better choice foods and at least fifty percent (50%) of the beverage items available for sale at a school or on school grounds must qualify as better choice beverages. food and beverage items are subject to the following for purposes ofthis subsection: (3) food items that meet all the following standards are considered better choice foods: 47. thomasj. lueck and kim severson, new york bans most trans fats in restaurants, n.y. times, dec. 6, 2006, at at, available at http://www.nytimes.com/2006/12/06/ nyregion/06fat.html. 48. see jocelyn noveck, n.y. city bans trans fats at eateries, san jose mercury news, dec. 6, 2006, at 8a; annys shin, trans fat banned inn. y. eateries; city health board cites heart risks, wash. post, dec. 6, 2006; katherine hobson, diet, fitness & exercise; nyc bans trans fats, u.s. news & world report, dec. 5, 2006, available at http://health.usnews.com/usnewslhealth/articles/061205/5health.transfat.htm (doing a google news search for "new york city bans trans fats" produces 11,600 hits). 49. see nat'l restaurant ass'n., 2007 state legislative session summary 5 avail­ able at http://www.restaurant.org/pdgslgovemment/07 _state _legislative_ suonnary.pdf(provid­ ing a detailed list of cities, counties, and states that have proposed or passed legislation as of aug. 27, 2007). recently, california became the only state to pass a trans fill restaurant ban. the state law regulates trans fats similar to new york city ban. see daniel shelton, review of se­ lected 2008 california legislation: health and sqfety: chapter 207: california's fight against trans fats, 40 mcgeorge l. rev. 426 (2008), for a summary analysis of california's ban. 334 indiana heal til law review (a) not more than thirty percent (30%) of their to­ tal calories are :from fat. (b) not more than ten percent (10%) of their total calories are :from saturated and trans fat. 50 [vol. 6:325 school lunches are currently the only form of foodstuffs regulated by the state government to reduce the amount of trans fat consumption. interestingly, this regulation is seemingly at odds with the u.s. departmentofhealth and human services recommendation that saturated fat consumption be kept at 10% of the daily caloric intake and that trans fat "consumption [be] as low as possible.'.s1 2. movements promoting a healthy lifestyle in indiana the most prevalent health movement in indiana is governor mitch da­ niels' initiative for an "in shape indiana. "52 this voluntary program encourages indiana citizens to create an online account that helps monitor exercise, weight loss, and nutrition. the website's nutritional information mainly consists of links to other nutritional information sites, 53 and includes an on-going question and answer session with a nutritionist. 54 this nutritionist provides relevant in­ formation about trans fats, but that information is buried throughout one hun­ dred and seventeen questions listed on the website. 55 as mentioned above, the links to nutrition websites provide important information. unfortunately, that information has been identified as confusing to most consumers. 56 additional­ ly, much of the information is tailored to meals and snacks that are prepared at home. no information concerning restaurant food exists on the website. the indiana department ofhealth website lists information about several public health programs, including the aforementioned inshape indiana pro­ gram. 57 information about trans fat is included in a public notice about the "subway guy,''58 a "national nutrition month" quiz,s9 and a tip-of-the-month that suggests shoppers "[g]o easy on foods with trans fatty acids, found in many 50. ind. code§ 20-26-9-19 (2006) (emphasis added). 51. u.s. dep't of heal1h and human serv., u.s. dep't of agric., publ'n no. 232, dmtary guidelines for americans 30 (2005), available at http://www.healtb.gov/dietary guidelinesldga2005/document/pdf7dga2005.pdf 52. inshape indiana, http://www.in.gov/insbapel (last visited jan. 16, 2008). 53. insbape indiana: nutrition home, http://www.in.gov/insbape/2267 .btm (last visited jan. 16, 2008). 54. insbape indiana: ask the nutritionist, http://www.in.gov/insbape/2271.btm (last visited jan. 16, 2008). 55. id 56. international food information council, supra note 39, at 4. 57. ind. state dep't of health, http://www.state.in.uslisdb/ (last visited jan. 16, 2008). 58. press release, ind. state dep't ofhealtb, nutrition article (nov. 14, 2006}, available at http://www.in.gov/isdb/files!nutritionarticlerx.pdf 59. step up to nutrition & health, national nutrition month 2006 nutrition quiz, http://www.in.gov/isdblprograms/cnoplnutrition _ montb/2006 _ nnm _ quiz.pdf(last visited jan. 16, 2008). 2009] awful taste of partially hydrogenated on.. 335 processed foods. ,.6o the indiana general assembly also released a pamphlet promoting a healthy lifestyle for women that encourages women to "[ c ]boose foods that are low in trans fat, saturated fat and cholesterol. '.61 at a local level, the marion county health department has failed to pro­ vide information concerning trans fats to the public. 62 the website does in­ clude a fast food restaurant eating guide, entitled "fast food switcheroo," that encourages individuals to eat smaller portions of the food offered or choose different menu items. 63 this guide, however, recommends foods that are high in trans fat, without any mention of the dangers of trans fats.64 indiana officials did make small steps when they chose to eliminate a tra­ ditional, local source of trans fat from the food landscape in 2008. the indiana state fair advisory committees removed trans fat from the oils used to cook food at the annual fair. 65 this was a voluntary process, "in which [fair officials] spent the winter months testing various oils and, despite the fears of some con­ cessionaires about possible changes to taste or costs or tradition, concluded that trans-fat-free oils created what ms. hoye [the executive director of the indiana state fair] called a betterproduct.'.66 the state fair advisory committee also noted the public attention that the indiana state fair received because of the trans fat policy adopted. 67 the new york times covered the trans fat ban on its front page,68 and several other state fairs nationwidewith momentum from indiana--i"emoved trans fats from their vendors. 69 b. new york city's ban on trans fats new york city's highly publicized ban on trans fats was a monumental regulatory move. the ban affected nearly 25,000 food serving establishments 60. ind. state dep't. of health, nutrition month tip of the day, available at http://www.in.gov/isdh/files/tip-of-tbe-day.pdf(listing the tmns :firt tip under the march 20, 2006 tip). 6i. indiana house ofrepresentatives' democratic publications office, healthy women, 4, available at http://www.in.gov/legislativelhouse _ democrats/pdt7womenshealth _ vanden burgh.pdf(last visited nov. 7, 2007). 62. marion co. health dep't, online, http://www.mchd.com/ (last visited nov. 7, 2007). 63. marion co. health dep't, fast food switcheroo, available at http://www.mchd. com/pdt7fastfoodswitch.pdf (last visited mar. 5, 2008). 64. see generally burger king nutritional guide, http://www.bk.com/nutrition!pdfs/ brochure.pdf (last visited mar. 5, 2008) (the marion county health department's fast food switcheroo, supra note 62, offers burger king's chicken tenders as a suitable replacement for a chicken sandwich. according to burger king's nutrition guide the chicken tenders contain three grams of trans :firt per serving.) 65. monica davey, yes,deep-friedoreos, but not in trans fats, n.y. times,aug.2i, 2007, at ai, available at http://www.nytimes.com/2007 /08/21/us/21 fat.html 66. id 67. state f airadvisorycommitiee, interjmcommrrreembetingminutes, at2 (lnd 2007), available at http://www.in.gov/legislativelinterim/committeelminutes/sfaca9k. 68. /d. 69. see davey, supra note 65, at ai; see also kathryn masterson, fair foods with less guilt? some are trans fat free, l.a. times, jul. 9, 2007, at f5. 336 indiana health law review [vol. 6:325 that have annual sales of around $11.3 billion. 70 in comparison, indiana has approximately 11,000 food serving establishments statewide and generates about $8.3 billion in sales. 71 new york city's ban was the first large-scale food regulation based upon dietary information. the ban on trans fat was specifically implemented to im­ prove the health of all new yorkers. 72 while the ban has drawn criticism, it has been widely imitated throughout the united states and the world. 73 the importance of new york city's ban cannot be overlooked and must be ana­ lyzed to determine how the large-scale trans fat ban has been such a success. 1. voluntarily removal oftrans fats fails in new york city the first stage of new york city's ban, the "educational initiative," began in early august 2005.74 the goal of the educational initiative was to encourage "restaurateurs and food suppliers to voluntarily make an oil change by eliminat­ ing partially hydrogenated vegetable oils from the kitchen."75 the new york city department of health and mental hygiene ("dohmh") created the edu­ cational initiative in reaction to the fda's recommendation that trans fat intake be kept as low as possible. 76 additionally, the dohmh conducted a survey and found that "30% of [new york city] restaurants used oils or fats known to contain partially hydrogenated vegetable oil for cooking or frying, or in spreads, such as margarine.'m the educational initiative used several forms of media to spread informa­ tion about trans fats and tips for how to "clear your kitchen of trans fats."78 the dohmh campaign's central tool was a mass letter and educational brochure 70. new york city restaurant association, new york city restaurant statistics, http://nysm.affiniscape.com/associations/2487/filesinyco/o20statistics.pdf(last visited feb. 12, 2008). 71. national restaurant association, indiana restaurant industry at a glance, http://www.restaurant.org/pdfs/research/state/indiana.pdf(last visited feb. 12, 2008). 72. n.y. comp. codes r. & regs. tit. 24, § 81.08, background (2007) (explaining that "[t]he public health concern addressed by this amendment is the presence of trans fat in foods served in restaurants, which represents a dangerous and entirely preventable health risk to res­ taurant goers. yet new york city restaurant patrons currently have no pmctical way to avoid this hannful substance." !d.). 73. see bantransfats.com, ban tmns fats: the campaign to ban partially hydrogenated oils, http://www.bantransfat.com. (last visited feb. 12, 2008) (since new york enacted their trans fat ban, approximately, a combined forty cities, counties, states and foreign countries have either implemented trans fat bans or are in the process of doing so.) 74. press release, new york city dep't ofhealth and mental hygiene, health depart­ ment ask restaumteurs and food suppliers to voluntarily make an oil change and eliminate artificial trans fat (aug. 10, 2005), available at http:/lwww.nyc.gov/htmvdoh/html/pr/pr08305.shtml. 75. !d. 76. !d. 77. id 78. does your kitchen need an oil change?, supra note 25, at 1. 2009] awful taste of partially hydrogenated oil 337 sent to "20,000 restaurants and 14,000 supermarkets and food suppliers."79 additional information was made available on the oohmh' s website and through a phone hot line. 80 the campaign strategy is interesting because the dohmh did not just spread information about the health dangers of trans fat, but it also focused on helping restaurants to identify what products contained trans fats and how to replace them. 81 the oohmh used a supportive and prac­ tical approach, as opposed to fear-based tactics designed to scare restaurants into trans fat replacement. 2. the shift to a mandatory ban on trans fats the educational initiative, however, was only backed by a voluntarily trans fat removal program.82 after one year, additional oohmh surveys de­ termined trans fat ''use remained common and [did] not decline substantially despite the trans fat education campaign."83 in response to the sluggish vo­ luntary response to the educational campaign, the oohmh enacted the manda­ tory trans fat ban. the dohmh amended the new york city health code concerning food preparation and enforcement to include: "no foods contain­ ing artificial trans fat, as defined in this section, shall be stored, distributed, held for service, used in p!':faration of any menu item or served in any food service establishment ... .' the regulation was a two-part ban that that also managed to take transition costs into consideration. the first phase of enforcement began on july 1, 2007.85 this limited the ban to "oils, shortenings and margarines containing artificial trans fat that are used for frying or in spreads. "86 the second phase began on july 1, 2008 and affects "oils or shortenings used for deep frying of yeast dough or cake batter, and all other foods containing artificial trans fat.'.s7 2008's interim was de­ signed to give bakeries an additional year to develop methods to remove trans fat from their kitchens. 88 there are limitations, as the ban only applies to food 79. press release, new york city dep't ofhealth and mental hygiene, health depart­ ment ask restaurateurs and food suppliers to voluntarily make an oil change and eliminate artificial trans fat, supra note 74 .• 80. does your krrchbn need an on. change?, supra note 25, at 2. 81. jd. 82. see press release, new york: city dep't ofhealth and mental hygiene, health l)e.. partment ask restaurateurs and food suppliers to voluntarily make an oil change and elimi­ nate artificial trans fat, supra note 74. 83. n.y. comp. codesr. &regs. tit. 24, § 81.08 (2007). 84. id 85. jd. 86. id 87. id. 88. see kim severson, trans fat claims butter as a victim, n.y. times, mar. 7, 2007, available at http://www.nytimes.com/2007/03/07/dining/07tran.html. see also baking man­ agement, problem: lowering trans-fat, saturated fat levels in bakery goods, bttp:/lbakingmanagement.bakery-net.com/article.php?wid=l6055 (last visited mar. 6, 2008) (discussing the difficulty that bakeries have in removing trans fats from their recipes). 338 indiana health law review [vol. 6:325 prepared in the kitchen of a restaurant and is inapplicable "to food served in the manufacturer's original, sealed packaging, such as a package of crackers or a bag of potato chips. "89 inspection of restaurants for use of trans fats is now included in the nor­ mal restaurant inspection by the dohmh.90 restaurants are required to keep food labels for products until that product is completely used up.91 if inspectors discover food that contains more than 0.5 grams of trans fat per serving, the restaurant will be cited for violations.92 these violations, however, are not counted against restaurants' overall "inspection score."93 the violations typi­ cally amount to fines, ranging from $200 to $2000.94 a three-month grace pe­ riod where no fmes were levied was included at the beginning of the first-phase of the ban.95 3. but, is it working? at publication, the ban has been in full effect for a full two years. reports claim that it has been effective in the elimination of trans fats from restaurants. in september of2007, the dohmh announced, "[s ]orne 94% of the more than 3,300 restaurants inspected between july 1 and september 1 had switched to spreads and oils containing zero grams of artificial trans fat. "96 another inde­ pendent study conducted in august of2007, however, revealed that three of the biggest fast food chains were still serving french fries with trans fat content that was nearly six times the allowable amount.97 more evidence will have to be collected to determine whether the trans fat ban is effective in removing a sig­ nificant portion of trans fat from the diets of most new york city citizens. as of now, studies are suggesting contradictory answers. n. government authority and its limits promoting public health is an essential function ofthe government on all 89. n.y.c dep't of heal1h and mental hygiene, lim r.egulation to phase out artificial trans fat in new york city food service establishments 1 (2007), available at, http://home2.nyc.govlhtml/dohldownloads/pd£icardio/cardio-transfat-bro.pdf [hereinafter lim regulation to phase out trans fat]. 90. id. 91. jd. 92. jd. 93. id 94. id. 95. lim regulation to phase out trans fat, supra note 84. 96. press release, new york city dep't ofhealth and mental hygiene, 94% ofinspected restaurants in compliance with first phase of trans fat regulation (sept. 17, 2007), available at http://www.nyc.gov/html/doh/htmllpr2007/pr080-07 .shttnl. 97. sewell chan, want some trans fats with those fries? n.y. times, aug. 2, 2007, available at http:l/cityroom.blogs.nytimes.com/2007/08/02/want-some-trans-fats-with-those­ fries 2009] awful taste of partially hydrogenated oil 339 levels and throughout american history: "[ c ]ities such as boston and new york have regulated public health matters for longer than they have been part of the united states."98 few dispute that the government should be involved in pub­ lic health regulation; rather it's the mechanics of implementing public health regulation that often causes disagreement. the idea of government in america is not based on a positive duty to act in support of its citizens. american gov­ ernment is, instead, based on the notion that "[t ]he constitution ... imposes no affirmative obligation on the government to act, to provide services, or to pro­ tect."99 that ideology, alone, does not explain why society generally opposes new public health measures. lawrence 0. gostin offers four possibilities as to why government action regarding public health is "politically and publicly un­ popular: " 1 00 (i) the rescue imperative society is willing to spend money inordinately to save a life of a person with a name, face and history, but less so to save "statistical lives;" (2) the technological imperative -public health services are less appealing and salient than the high technology solutions of microbiology and genetics; (3) the invisibility of public healthwhen public health is working well (e.g., safe food, water, and products), its importance is taken for granted; and (4) the culture of individualismsociety often values personal goods (in­ dividual responsibility, choice and satisfaction) over public goods (population health and safety). 101 even though public health regulations are an important element to ensuring the continuity of the country, gostin's four possibilities highlight the ease to with which people can, and will, ignore and discredit the importance of public health and welfare. this theory may also provide a glimpse into the rationale behind why existing public health laws, such as helmet laws, seatbelt laws, and smok­ ing bans, are often met with opposition in the form of litigation.102 while go­ vernmental mandates banning trans fats have so far been successful at the city and county level, opposition at the state level may increase due to any of these 98. edward p. richards, public health law as administrative law: example lessons, 10 j. healtii carel. & pol'y 61, 64 (2007). 99. see lawrence 0. gostin, public health theory and practice in the constitutional design, 11 healtiimatrix: j. l. med. 265, 268 {2001). i 00. lawrence 0. gostin, health of the people: the highest law?, 32 j.l. med& ennes 509, 509 (2004). 101. !d. 102. see d.a.b.e. v. city of toledo, 393 f.3d 692 (6th cir. 2005) (upholding a city's smoking ban in restaurants and bars); abate of georgia v. georgia, 137 f. supp. 2d 1349 (n.d. ga 2001) (upholding laws requiring motorcyclists to wear helmets); state v. hartog, 440 n.w.2d 852 (iowa 1989) (upholding state law requiring motorists to wear seatbelts). 340 indiana hea.lrn law review [vol. 6:325 four possibilities. hence, it is imperative to look at other recent public health measures in indiana to determine the level of opposition that could impede the indiana general assembly from implementing a trans fat ban. running contrary to the public opinion of health regulations is the large amount of deference courts generally give the government when reviewing public health laws. justice harlan explained the need for this deference in the seminal case, jacobson v. massachusetts, as a balance between individual liber­ ty and the need for public safety, since it is "a fundamental principle that 'per­ sons and property are subjected to all kinds of restraints and burdens in order to secure the general comfort, health, and prosperity of the state .... "103 the de­ velopment of judicial standards from this foundation has created the legal at­ mosphere in which "[s ]tates are generally :free to provide greater protection than are required by the united states constitution or individual state constitu­ tions. "104 the high level of deference that states receive from courts indicates that any legal challenge to a state's trans fat ban will not be successful. a. indiana's authority to regulate food establishments the regulatory authority behind indiana's food establishment law is rooted in the traditional police powers of the state.105 accordingly, the indiana legislature is afforded a large amount of deference when regulating food for the welfare of its citizens: [i]fthe legislature oflndiana in the reasonable exercise of its police power, and for the welfare of its citizens, condemns as an adulteration the use ofbenzoate of soda in the preparation of articles of food, then, in the absence of a general acceptance of the proposition by the scien­ tific world that such is not the case, there can, as to that 103. jacobson v. massachusetts, 197 u.s. 11, 26 (1903)(citations omitted) (holding that the state did not violate the due process clause of the 14th amendment by mandating vaccina­ tions for its citizens). see also williams v. mayor ofbaltimore, 289 u.s. 36 {1933) (citations omitted). the williams court further explained the reasoning behind the jacobson standard: id at 42. it is not the function of a court to determine whether the public policy that finds expression in legislation of this order is well or ill conceived. the judicial function is exhausted with the discovery that the relation between means and end is not wholly vain and fanciful, an illusory pretense. within the field where men of reason may reasonably differ, the legislature must have its way. 104. edward p. richards, public health law as administrative law: example lessons, 10 j.iieal1h carel. & pol'y 61, 88 (2007). 105. see albert v. milk control bd., 200 n.e. 688, 691 (ind. 1936) (explaining that the police powers of the state generally allow the legislature to regulate the milk industry to ensme milk "for human consumption be wholesome and healthful.''). 2009] awful taste of par11au..y hydrogenated on.. matter, arise no question of the violation of the constitu­ tion of the united states, or, as here charged, of the state of indiana. when deemed necessary by the legislature for the public health, property rights such as here in­ volved must give way. 106 341 due to the large amount of deference given to the state, restaurants are heavily regulated in indiana. most of the regulations were originally adopted to meet the standards of the uniform federal drug and cosmetic act107 and to "safeguard the public health."108 additionally, the indiana code gives the state department of health power to establish rules .. for the efficient enforcement" of the sanitary requirements forrestaurants. 109 restaurateurs must comply with the extensive and detailed list of regulations established by the administrative code.110 each provision of this list was implemented underneath the umbrella of public health. indiana case law reviewing the authority of the state to promulgate regu­ lations is dated and fairly limited .. the cases, however, provide the basis for future regulatory schemes that are an inherent part of the state's police power. 1. curtice bros. co. v. barnard curtice brothers v. barnard, a decision by the seventh circuit court of appeals, challenged an indiana law that banned the use and sale of soda ben­ zoate and subsequently gave authority to criminally prosecute those who sold it.111 the plaintiffs/appellants challenged the law under several legal theories, most notably the fourteenth amendment of the federal constitution.112 the law challenged was a broad regulation that prevented the use of additives in food unless the state board of health had previously approved them.113 the fourteenth amendment challenge required the court to apply a ba­ lancing test between the interests of the individual and the state's interest in 106. curtice bros. co. v. barnard, 209 f. 589,593-94 (7th cir.l913)(holdingthatlndi­ ana's ban on using benzoate of soda in food preparation is constitutional because there is no evidence that directly contradicts the reasonable findings of the state legislature). see also wal­ lacev. feehan, 190 n.e. 438,442 (ind. 1934) (explaining that "whatever constitutes areal me­ nace to such supply may be legitimately declared by statute to be a public nuisance.") (quoting bowman v. virginia state entomologist, 105 s.e. 141, 145 (va. 1920)). 107. 21 u.s.c. § 301 (1938). 108. ind. code§ 16-42-1-1 (2006). 109. ind. code§ 16-42-5-5 (2006) (giving authority to the state department based on ind. code. § 4-22-2). 110. see generally 410 ind. admin. code 7-24 (2008) (under "sanitary standards for the operation of retail food establishments," rule 24 of the indiana administrative code lists nearly 450 separate regulations, including employee hand washing, shellstock condition, and the proper method for drying mops.) ill. curtice, 209 f. at 589. 112. ld. {citing u.s. const. amend. xiv). 113. id 342 indiana health law review [vol. 6:325 promoting public health.114 the court held the law constitutional because the state of indiana was reasonably applying its police powers when it created the law.115 the court found that the individual interest companies had in using soda benzoate was weaker than the interest in promoting the public welfare of indi­ ana citizens. in issuing such a holding, the court applied a "reasonable basis" test in analyzing the law while giving a great deal of deference to the legisla­ ture.ll6 the appellants' complaint argued that the indiana constitution prohibited the application of the state board ofhealth law because it allowed officials ''to distinguish as between harmless preservatives, pennitting the use of some and prohibiting the use of others arbitrarily."117 the court rejected this interpreta­ tion and determined that the statute limited the state board ofhealth ''to ascer­ tain and declare what is a harmless preservative, and that it is not authorized thereby to exclude the use of any preservative which it finds to be hannless."118 the court found that the law did not grant arbitrary power to the state board of health and upheld the law.119 despite its age, curtice remains a key case be­ cause of the role deference was given with respect to the legislature and its scientific findings. the court admitted that the scientific community had not yet come to a consensus as to whether soda benzoate was harmfu1.120 the un­ certainty surrounding the hazards of using soda benzoate, however, did not im­ pair the legislature from regulating its use. 121 thus, it was the burden of the appellant, and not the state, to prove that soda benzoate was safe and not the state to prove it was harmfu1.122 the court's ruling established a large base from which the legislature is allowed to regulate food. even without certain scientific evidence, the legislature is allowed to regulate food because the state has such an invested interest in the public health. 2. albert v. milk control bd. in 1935, indiana passed the milk control act,123 due to an "emergency concerning the production and distribution of milk."124 the act created a milk 114. /d. at 593 (citing state v. layton, 61 s.w. 171, 177 (mo. 1901)). 115. id 116. /d. at 594 (stating that if the indianageneralassemblyengagedin a "reasonable exer­ cise of its police power ... for the welfare of its citizens" to enact a law the court would not hold it unconstitutional.) (emphasis added). 117. curtice, 209 f. at 594. 118. id. 119. /d. 120. id. at 592 ("(i]t is evident that the question of the harmfulness and harmlessness of benzoate of soda is, as yet, an open one in the scientific world."). 121. /d. 122. /d. 123. the milk control act, ch. 281, 19351nd. acts 1365 (hereinafter the "milk control act"). 124. albert v. milk control bd., 200 n.e. 688, 690 (ind. 1936) (citing the milk control 2009] awful taste of partially hydrogenated oil 343 control board (the "board") to regulate quality of milk production and ensure price stability. 125 the board had the authority to issue penalties to those who violated the emergency provisions.126 the plaintiffs in albert appealed a penalty imposed for "engag[ing] in the business of milk dealer, processer, distributor­ producer, and distributing broker of milk without paying the license fee im­ posed, and without obtaining a license!'127 the plaintiffs' chief complaint challenged the constitutionality of the milk control act underneath article 1, section 1 of the indiana constitution, arguing the act violated their "natural rights."128 the court analyzed the constitutional challenge on the basis of the state's police power, reasoning "[i]f the act in question properly comes within the police power of the state, then it is not in violation of said article and section. "129 the court determined that indiana was properly exercising its police powers over milk considering the long-standing history of state-based milk regulation, accompanied by the fact that nearly every other state also regulated milk.130 the court held that the state could properly exercise its police power ''to require that milk for human consumption be wholesome and healthfttl."131 the court also juxtaposed the rights of the individual compared to the rights of the public at large.132 the individual right invoked by the plaintiffs was trumped by the public's right, ''through the legislature, to regulate [milk] for the benefit of the common interest of all."133 the public's interest was based on milk's "direct relation to public health and the general welfare of the people."134 as a result of this public interest, the plaintiffs had to conform their business practices to meet the standards and license qualifications set forth by the state. 135 the albert opinion sets the bar for state regulation of the food supply and may possibly be interpreted as superseding any individual interest-so long as the state is regulating under the scope of the traditional police powers and the matter being regulated has a connection to health and welfare of the public. b. commerce clause limitations a statewide ban on trans fats raises a potential conflict between federal authority and state police powers underneath the commerce clause.136 there act). 125. the milk control act. ch 281. 126. id. 127. albert, 200 n.e. at 689. 128. /d. at 690. 129. id. 130. id. 131. ld. 132. albert, 200 n.e. at 691. 133. id. 134. id. 135. id. 136. u.s. const. art. i, § 8, cl. 3 344 indiana heal til law review [vol. 6:325 are two potential ways a state-enacted trans fat ban may not survive a com­ merce clause challenge: if it is found in violation of the dormant commerce clause or if federal preemption in the field of regulating trans fats already ex­ ists. a state regulation that places restrictions on businesses that are intert­ wined with the national stream of commerce could be challenged underneath the dormant commerce clause theory.137 a countless number of national res­ taurant chains exist all over the state of indiana and local restaurants often re­ ceive supplies from a national distributor. a statewide ban on trans fats places a kink in the national commercial activity of the restaurant business. suppliers for all indiana restaurants would have to tailor any indiana deliveries to meet the standards imposed by a trans fat ban. the commerce clause, however, does not preclude all state regulation. 138 it is likely that as long as the trans fat ban was applied evenly to all restaurants, whether local or national in character, a commerce clause challenge would fail. 139 a statewide trans fat ban also raises federal preemption concerns because the federal government has enacted regulation concerning trans fat. on july 9, 2003 the fda enacted a new food labeling regulation that required food manu­ factures to include information about the trans fat content of all labeled foods. 140 the nutrition labeling of food rule,141 requires that any foods with more than 0.5 grams of trans fat include the number of grams of trans fat on the nutrition label.142 this rule is the only federal action that regulates anything related to trans fat. the fda's action is limited to nutritional labeling and does not preempt state action from regulating trans fats with other measures. 1. dormant commerce clause limitations the commerce clause authority has well-established standards "framed upon the theory that the peoples of the several states must sink or swim togeth­ er, and that in the long run prosperity and salvation are in union and not divi­ sion. "143 it is well-known that the commerce clause provides congress a large amount of discretion ''to regulate commerce ... among the several states."144 the goal of the commerce clause and its broad grant of congressional power 137. see generally black's law dictionary (8th ed. 2004) ("dormant commerce clause. the constitutional principle that the commerce clause prevents state regulation of in­ terstate commercial activity even when congress bas not acted under its commerce clause pow­ er to regulate that activity."). 138. see generally 15 c.j.s. commerce§ 14 (2008). 139. id. 140. press release, dep't ofhealth and human services, hhs to require food labels to include trans fat contents (july 9, 2003) available at http://www.hbs.gov/news/press/ 2003pres/20030709.html. 141. nutrition labeling of food, 21 c.p.r. § 101.9 (2006). 142. id. at 101.9(cx2xii). 143. gov't suppliers consolidating services, inc. v. bayb. 753 f.supp. 739, 763 (s.d. ind. 1990) (quoting baldwin v. g.a.f. seeling, inc., 294 u.s. 511, 523 (1935)). 144. u.s. const. art. i, § 8, cl. 3. 2009) awful taste of partiau.y hydrogenated oil 345 is at odds with the purposes of a state's inherent police powers.145 in particular, the dormant commerce clause doctrine restricts the states' ability to regulate even in the absence of federal regulation.146 a state enacting regulations to pro­ tect their citizens must pass one of two tests. if a state regulation is facially dis­ criminatory or discriminatory in its effect ''the burden falls on the state to justify [the regulation] both in terms of the local benefits flowing from the sta­ tute and the unavailability of nondiscriminatory alternatives adequate to pre­ serve the local interests at stake."147 the second test, derived from pike v. broce church, inc., 148 applies to state regulations that are applied "evenhanded­ ly to effectuate a legitimate local public interest, and its effects on interstate commerce are only incidental ... "149 the pike test only invalidates a state reg­ ulation if its application imposes a burden that is "clearly excessive in relation to the putative local benefits. "150 it is unlikely that a court would apply the first test to a trans fat ban.151 a correctly written trans fat ban would not be facially discriminatory because it would theoretically apply to both local and national restaurants. nor would a trans fat ban be discriminatory in effect because both local and national restau­ rant chains would have similar burdens to modify their operations. 152 thus, courts would likely use the pike test to determine whether a trans fat ban vi­ olates the dormant commerce clause. the pike test is designed to balance the burden and the benefit of a state regulation to determine if the regulation is actually worth the costs it impos­ es.153 as already noted, a trans fat ban would apply evenhandedly to all restau­ rants in indiana. there may, however, be a question of whether the burden of a trans fat ban is too heavy in comparison to the benefits it provides.154 this ban would no doubt be a regulation designed to promote the health 145. see generally elizabeth young spivey, trans fat: can new york save its citizens from this "metabolic poison?", 42 ga. l. rev. 273, 294 (2007). 146. seeblack'slawdictionary,supranote 137. 147. hunt v. wash. apple adver. comm'n, 432 u.s. 333, 353 (1977) (citations omitted) (holding north carolina's apple grading statute was unconstitutional because its discriminatory effect on interstate commerce was economic protectionism). 148. pike v. bruce chw'ch. inc., 397 u.s. 137 (1970). 149. id. at 142 (citations omitted) (holding that an arizona law regulating the packing of agriculture products was unconstitutional despite its evenhanded application because it was too heavy of a burden on interstate commerce). 150. id. 151. see hunt, 432 u.s. at 353 (citing the first test of the dormant commerce clause). 152. see spivey, supra note 145, at 297-302, for an analysis ofnew york city's trans tat ban using the commerce clause test for regulations that are facially or effectively discriminato­ ry. 153. see generally james d. fox, state benefits under the pike balancing test of the dormant commerce clause: putative or actual?, 1 avemarial.rev.l75,176(2003)(dis­ cussing the practical, but chaotic, effect of evaluating state benefits underneath the pike balanc­ ing test). 154. u.s. v. lopez, 514 u.s. 549, 580 (1995) (j. kennedy concuning) ("distinguishing between regulations that do place an undue burden on interstate commerce and regulations that do not depends upon delicate judgments"). 346 indiana realm law review [vol. 6:325 of the public. typically, courts give broad discretion to public health and safety laws when applying analyses of the dormant commerce clause.155 however, no bright line test exists to clearly define when a burden becomes so heavy it outweighs the interests of public health and safety.156 the supreme court has upheld public health and safety laws such as a state regulation requiring im­ ported meat be disease-free certified, 157 a statewide ban on the sale of milk in plastic containers, 158 and a waste flow control ordinance that significantly in­ creases recycling.159 the court's analysis in these cases focused on the benefits that these regulations provided, with little discussion on the burdens im­ posed.160 on the other end of the pike balancing test, the court has invalidated a state law that limited truck length on local highways161 and a state law that required trucks to use a specific style of mudguards.162 in both cases, the court used a cost-benefit method of analysis to determine whether the burden im­ posed on interstate commerce was too high.163 if the court determines a state regulation provided a substantial or vital benefit to the public's health or safety, it is unlikely to overturn the regulation no matter how burdensome the regulation may be.164 conversely, if the court finds that the state regulation is not very beneficial, even a minimal burden may invalidate the state regulation.165 thus, it is important for the state to emphas155. see wendy e. parmet,after september ii: rethinking public health federalism, 30 j.l. med & ennes 201, 202-03 (2002). 156. see generally fox, supra note 153, at 177 (discussing 1he practical eft'ect of evaluating state benefits underneath the pike balancing test). 157. mintz v. barber, 289 u.s. 346 (1933)(upholdingtheregulation because it allowed other states to certify meat without placing a complete ban on out-of-state meat). 158. minn. v. cloverleafcreameryco.,449u.s.456(1981)(upholdingaminnesotaban on plastic milk: jug containers because the regulation was designed to increase resource conser­ vation). 159. unitedhaulersass'n,inc. v. oneida-hedrimersolid wastemgmt.auth., 127 s.ct. 1786 (2007) (upholding a new york solid waste regulation that required all trash be routed 1hrough a locally owned facility because it increased recycling). 160. see mintz, 289 u.s. at 359 (reasoning that the meat certification ''was promulgated in good fhllh and is appropriate for 1he prevention of further spread of 1he disease among dairy cattle and to safeguard public heallh. it cannot be maintained 1herefore 1hat 1he order so unne­ cessarily burdens interstate transportation as to contravene 1he commerce clause"). 161. kassel v. consol. freightways corp., 450 u.s. 662 (1981) (holding that iowa's ban on trucks longer than sixty feet imposed a burden on interstate commerce that outweighed any public safety 1he ban provided). 162. bibb v. navajo freight lines, inc., 359 u.s. 520 (1959) (holding that illinois' curved mudguard requirement did not provide a substantial public safety benefit to justify 1he large burden on interstate commerce). 163. c.f id at 525-27 (the bibb court asserted that cost of the safety regulation is not the only tool of analysis. the court also examined the delay that 1he regulations could impose on interstate truck traffic. delay in commercial traffic, however, is another way of analyzing the cost of 1he illinois regulation because 'time is money.') 164. see generally fox, supra note 153, at 178 (stating that"[1jhe state benefits analysis is often the determinative factor in pike cases."). 165. see generally id. at 208-209. (discussing how courts have interpreted 1he pike test and the subsequent result of unpredictable decision because courts have not applied the test consis­ tently.) 2009] awful taste of partially hydrogenated oil 347 ize the benefit of a public health regulation. courts are more likely to presume the regulation is valid if the benefits are substantial, rather than trying to at­ tempt to minimize the burdens. the latter argument is less likely to be success­ ful. in the context of trans fats, it is likely that a court would hold that the ben­ efit of the ban outweighs the burden. several studies have shown a dramatic increase in coronary heart disease is connected to just a small increase in con­ sumption of trans fats. 166 removing trans fats could potentially save the lives of thousands of hoosiers every year. 167 a statewide trans fat ban would also raise awareness about the dangers of eating trans fats and encourage healthier eating habits. these benefits, however, are somewhat speculative. while stu­ dies have proven the dangers of trans fats, eliminating them from restaurants will not completely remove trans fats from american diets. 168 the health bene­ fits of banning trans fats in restaurants could be nullified if individuals begin consuming more at home. this is an unlikely scenario because more and more food manufacturers are removing trans fats from their products. 169 nonetheless, removing trans fats completely from a major source of indiana citizens' diets is a legitimate and important public health interest of the state that could help save and improve lives. the burden imposed by a trans fat ban is not oppressive. it forces private business owners to switch from products containing trans fats, but this is typi­ cally an easy and low cost move. 170 additionally, several alternative products exist that easily replace trans fats in the kitchen, giving more flexibility to res­ taurant owners to decide how to remove trans fats. 171 furthermore, some law and economic experts have crudely analyzed the cost-benefit of a trans fat ban and have determined the new york city ban is benefit positive.172 it is possible 166. see mozaffarian, supra note 15, at 1605. 167. see ind. statedep'tofhealth,lndianamortality rates-2006 (2008), availa­ ble at http://www.in.gov/isdhlreports/mortality/2006/table04/tbl04 _ oo.htm#idx18. approx­ imately 48,500 indiana residents died of heart related disease in 2006. according to mozaffarian, supra note 15 at 1611, removing trans fats could prevent six to nineteen percent of chd deaths each year. extrapolated over the indiana mortality data for 2006, removing trans fats could potentially save 2,900 to 9,200 lives. 168. see fda acts to provide belter information to consumers on trans fats, supra note 14 (explaining that food manufactures only have to identify trans fat content of food if it has over .5 grams of trans fat per serving. therefore, it is possible that food could have .49 grams of trans fut, but be identified as having no trans fats.). 169. see bantransfats.com. trans fat news, http://www.bantransfats.com/transfutnews. html (last visited mar. 6, 2008), for a list of major food products that have removed trans fats. 170. see generally bantransfats.com, ban trans fats: the campaign to ban partially hydrogenated oils, http://www.bantransfats.com/index.html (last visited mar. 6, 2008), for a comparison of prices between partially hydrogenated vegetable oil and trans fat free oils. 171. see id. for a list of suppliers who sell trans fat free oils. 172. see generally the beckner-posner blog: the new york city ban on trans fats, http://www.becker-posner-blog.com/archives/2006/12/the _new _york_ ci.html (last visited oct. 24, 2008) (analyzing the new york city trans fat ban based on the estimated reduction ofheart attack deaths in new york city and the rough cost of implementing the ban by the new york city restaurant industry.) 348 indiana heal1h law review [vol. 6:325 that a trans fat ban could cause disruptions in the food distribution industry as restaurants shift to healthier oils, but no major problems have been reported since new york city enacted its ban. the economic impact that a trans fat ban in indiana would have on interstate commerce is beyond the scope of this note, but it is likely that any burden would be temporary.173 an indiana ban on trans fat is likely to pass a dormant commerce clause challenge. not only would a trans fat ban not discriminate against interstate commerce, it would also provide a substantial public health benefit to all indi­ ana residents. 2. the fda has not preempted state and local government bans on trans fats preemption of state action can occur when the federal government acts expressly to do so or through implied action.174 generally, food regulation is a joint venture between state and federal governments.175 regulation of domestic food is a traditional state police power.176 therefore, preemption of a state trans fat ban only occurs if the federal government has enacted regulations specifical­ ly addressing trans fats. the only federal regulation addressing trans fats is 21 c.f.r § 101.9.177 section 101.9 does not expressly preempt state action to regulate trans fats in general because the express preemption provision in section 403a of the na­ tional unifonn nutritional labeling act only limits state action with regard to food labeling standards.178 therefore, § 101.9 can only preempt state action if it does so implicitly. implied preemption may happen if federal action is so complete that it "[occupies an] entire field of regulation and has thereby 'left no room for states to supplement' federal law ... [if] compliance with both state and federal law is impossible ... or [if] state law 'stands as an obstacle to the accomplishment and execution of the full purposes and objectives of congress. '"179 a potential statewide trans fat ban and § 101.9 do not fall underneath any of the categories of implied preemption. while § 101.9 expressly preempts states from regulat­ ing food nutritionallab~ls, it does not completely encompass regulatory authori173. see id (providing a rough estimate of the cost-benefit of the new york city ban). 174. see generally pac. gas and elec. co v. state energy res. conservation & dev. com'n, 461 u.s. 190,203-04 (1983). 175. see generally wendy aguilar, the lowest common denominator: national unifor­ mity for food act, 16 san joaquin agric. l. rev. 57 (2006-2007) (discussing the history of domestic food regulation in the united states). 176. id at61 177. nutritionlabelingoffood,21 c.f.r. § 101.9(2006). 178. see generally national uniform nutrition labeling § 403, 21 u.s.c § 343-1 (2000) (section 343-1 governs all labeling requirements such 21 c.f.r § 101.9, therefore all express preemptiveprovisionsof21 u.s.c § 343-1 apply to§ 101.9). 179. capital cities cable, inc. v. crisp, 467 u.s. 691,699 (1984) (citations omitted). 2009] awful taste of partially hydrogenated on.. 349 ty over the content of food generally or the use of trans fats specifically. thennore, a trans fat ban does nothing to make complying with § 101.9 imposs­ ible. a trans fat ban regulates food preparation and in no way interferes with federal labeling requirements. similarly, a trans fat ban would do nothing to hinder the congressional purpose behind § 101.9.180 additionally, the fda has determined that § 101.9 only preempts state action "from imposing any nu­ tritional labeling requirements for trans fat that are not identical to those re­ quired by this rule."181 thus, a statewide trans fat ban does not have potential conflicts with any other federal regulation. unless the federal government enacts regulations in the future with regard to trans fats, a statewide trans fat ban will be a proper exercise of a state's traditional police powers. v. recommendation tiiat indiana removes trans fats from restaurants indiana has an opportunity to help improve the health of hoosiers signifi­ cantly without drastically increasing the state budget or entering uninvited into the personal habits of its citizens. the proper legal authority exists to take ac­ tion; the only barrier that remains is public opinion. as discussed previously, overcoming the four common oppositions to gublic support for public health action tends to be the highest hurdle to clear.1 choosing the right method for policy implementation can help combat those obstacles. a. public health regulatory options the government's job to promote health on the public scale is a difficult balancing act, with "complex tradeoffs between individual and collected inter­ est."183 lawrence gostin argues that government has "at least seven different models for legal intervention designed to prevent injury, and disease, encourage healthful behaviors, and generally promote the public's health. "184 the seven models are: (1) general tax powers, (2) information campaigns, (3) altering physical living environments, (4) altering socio-economic environment, (5) direct regulation, (6) tort system, (7) deregulation.185 each option allocates 180. see food labeling: trans fatty acids in nutritional labeling. nutrient content claims and health claims, 68 fed. reg. 41,434, 41,437-38 (july 11, 2003) (codified at 21 c.f .r § 10 1.9) (the fda's purpose for requiring trans tat to be labeled is to provide consum­ ers with the information needed to make healthy choices in food selection. removing trans tats from restaurants creates healthier choices for consumers, thus not conflicting with congress' objective.) 181. ]d. at 41,498. 182. gostin, supra note 100, at 509. 183. jd at 511 184. id 185. id. at 511-513. 350 indiana healrn law review [vol. 6:325 burdens in a variety of ways, allowing for different problems to be met with answers that fit closely to the issues at hand. regulating trans fats in restaurants presents a unique intersection of indi­ vidual and business interests. any law passed by indiana attempting to regulate hoosier's diets would face the challenge of either of the two main legal hurdles to any public health law.186 the law, however, would also affect business oper­ ations and food preparation methods in restaurants.187 any legislative action will likely produce strong opposition from restaurant owners based on the "cul­ ture of individualism."188 therefore, when dealing with the trans fat problem, it is crucial to choose the appropriate method of action to maximize health bene­ fits while generating support for a bill that may be perceived as personally and commercially intrusive. any legislation adopted should focus on meeting both of these broad goals. 1. taxing is not the answer the typical government model of"impos[ing] excise taxes in order tore­ duce the demand for 'demerit goods' that are harmful to health [such as] (to­ bacco)" would be hard to apply to trans fats.189 tobacco is a distinct product that is taxed separately when it is sold to consumers to reduce demand.190 tax­ ing trans fats, however, would be difficult because they are just one ingredient out of several ingredients found in most food products. therefore, the effect of reducing demand may be watered down because the tax on trans fat is per­ ceived as a tax on food in general, and not just on one distinct harmful product. other questions arise as to how a tax such as this should be applied in food establishments. should a restaurant have to a pay a tax on food that is pre­ fried in oil that contains trans fats? should food with more trans fat be taxed higher or should there be a flat tax for all foods with trans fats? should food that is taxed be easily identifiable or should it just cost more without any identi­ fication? any new taxation presents challenges in how it should be imple­ mented. these specific concerns surrounding a trans fat tax, however, present large roadblocks to the ultimate goal of any trans fat legislation: eliminating its consumption. adding an additional5% or even 200/o tax on food with trans fats seems futile. if french fries that nonnally cost $1.00 are increased to $1.05 or $1.20, would that really stop consumption? a tax would have to substantially increase the price of a trans fat food item for it to be an effective deterrence. 186. see supra part iv.b. 187. see bantransfats.com, the campaign to ban partially hydrogenated oils, http://www.bantransfats.com/index.html(lastvisitedfeb.l2,2008),foradiscussionofthemost prevalent critiques against a trans fat ban. 188. gostin, supra note 100, at 509. (defining the "culture of individualism [as the fact that] society often values personal goods (individual responsibility, choice, and satisfaction) over public goods (population health and safety)." ld. ). 189. magnusson, supra note 7, at 576. 190. ld 2009) awful taste of partially hydrogenated oil 351 increasing taxes or adding a new tax is typically politically unpopular. garner­ ing support from constituents and other members of a legislative body may prove to be difficult. 191 2. altering physical and socio-economic environments is too costly and does not directly address the problem of trans fats regulations adopted under these methods are hard to tailor specifically to the problem of trans fats. laws made and enforced to alter physical and socio­ economic environments enact large-scale projects that are expensive and time consuming.192 changing the layout of a city neighborhood or using zoning laws to provide a better opportunity for individuals to lead healthy lifestyles serve as a good long-term solution to america's health problem.193 these poli­ cies, however, do not provide a direct solution to the problem of trans fats. us­ ing this form ofhealth regulation would be an ineffective way to limit exposure to trans fats because the results can be gradual, indirect, and expensive. 3. litigation against restaurants would not be effective litigation against major food manufactures for the use of trans fats has been effective. 194• most of the lawsuits, however, have been based on hiding the ball from the public, or misleading the public into thinking that trans fats had been eliminated.195 although these lawsuits have led several large food manufacturers to remove trans fats from their products, 196 initiating litigation to remove trans fats from restaurants may be inefficient and ineffective. restaurants have already secured protection from obesity lawsuits. indi­ viduals who attempted to sue mcdonalds began to have success in obesity­ based lawsuits. 197 in response, several states, including indiana, have passed a "cheeseburger bill," which prohibits individuals from suing restaurants on the basis that the restaurants made them obese.198 indiana's "cheeseburger bill" 191. the recent discussion involving a food and beverage tax increase to help support indi­ anapolis's capital improvement board emphasizes the difficulty of getting a new food tax passed in indiana. the plan to increase food and beverage tax was removed from the plan due to pressure from the public and the restaurant industry. see mary beth schneider, cib plan met with jeers, indianapolis star, apr. 3, 2009, at al. 192. see gostin, supra note 100, at 512 (discussing how the government can alter the build environment to improve public health). 193. id. 194. molly selvin, lawyer who took on oreos and mcdonald's fights on in food war, l.a. times, sept. 25, 2005, at cl. 195. amended complaint for injunctive relief at 7, bantransfats.com vs. kraft foods north america, no. cv 032041 (dismissed may 1, 2003) (on file with author). 196. see supra notes 36-39. 197. tom becker & david glovin, mcdonald's must face claim that its food caused obesity, panel rules, wash. post, jan. 26, 2005, at e 10. 198. see generally, david burnett, fast-food lawsuits and the cheeseburger bill: criti­ quing congress 's response to the obesity epidemic, 14 va. j. soc. pol 'y. & l. 357 (2007). see 352 indiana health law review [vol. 6:325 specifically grants immunity to food establishments from civil liability arising from a claim concerning: (1) weight gain; (2) obesity; (3) a health condition associated with weight gain or ob­ esity; or (4) a generally known condition: (a) allegedly caused by; or (b) allegedly likely to result from; the long term consumption of food or beverages.199 the "cheeseburger bill" likely eliminates any chance that an individual could actually bring a lawsuit against a restaurant for causing heart disease related to the consumption of trans fats. heart conditions would likely fall under the heading of a "generally known condition." there is, however, a potential ar­ gument that it is not generally known that long-term consumption of trans fats causes heart disease. 200 even if a trans fat lawsuit against a food establishment was allowed, the chances of winning a tort-based claim against a restaurant for causing an indi­ vidual's heart problems are extremely low. how could an individual prove a restaurant serving trans fats was the most significant cause of a single cardiac disease event? would the individual's genetic history come into play? did the individual choose healthy items off the menu? there are numerous other sig­ nificant variables that come into play when trying to connect an individual's consumption of trans fats to heart disease. this is not to say that this type of litigation would never be possible, but using the tort system is not the most effi­ cient or effective way to remove trans fats from a restaurant's kitchen. b. indiana's solution to trans fat indiana's approach to trans fat should be a combination ofboth an infor­ mation campaign and direct regulation. using both strategies maximizes the benefit that the public can receive from a trans fat ban. new york city's ban of trans fats serves as an effective model to exemplify the steps indiana must take. for instance, new york city's informational campaign and year-long volunteer removal program did not have a major impact in decreasing trans fat use in res­ taurants;201 however, the campaign did help educate and inform new york city also ind. code§ 34-30-23-2 (2007).1nd. code§ 34-30-23-3 (2007) 199. ind. code§ 34-30-23-3 (2006). . 200. the strength of this argument, however, has not been tested yet because no one has challenged the "cheeseburger bill" or brought a suit against a restaurant for causing an un­ known condition. 20 l. see discussion supra part ill.b.l-2. 2009] awful taste of partially hydrogenated on. 353 residents about the dangers of trans fats.202 the year-long campaign. however, did place trans fat awareness at the forefront of media attention and exposed the public to valuable health information. 203 indiana legislators must craft legisla­ tion that both limits hoosier's exposure to trans fats in restaurants and also educates citizens to help them make healthy choices at home. 1. why use direct regulation? use of direct regulation to address public health issues can be controver­ sial. several "[i]nfluential economic theories (e.g.laissez-faire and, more re­ cently, a market economy) favor open competition and the undeterred entrepreneur."204 regulation is often seen as an impediment to a flourishing market economy because it limits the freedom of the individual. this is the very notion of which lochner v. new york was based.205 the lochner court used the due process clause of the fourteenth amendment in an attempt to protect the individual's freedom to contract.206 the same economically conservative supreme court, however, also authored the opinion injacobson.201 even in a time when the court was tepid about government regulations potentially limit­ ing individual freedoms, public health was exempt from a tougher level of scru­ tiny.208 that exception has grown over the years and regulatory action directly related to public health has been given wide latitude by the american judicial system. 209 indiana courts have also given wide latitude to the state when regu­ lating food for the public health.210 it is clear that the indiana general assem­ bly has the legal authority to enact a statewide ban of trans fats in restaurants.211 additionally, any subsequent legal challenge would likely fail due to the large amount of deference that courts traditionally give states when the regulation concerns the state's traditional police powers. 202. id. 203. id. 204. gostin, supra note 100, at 513. 205. seelochnerv.newyorlt, 198u.s.45(1905)(overtuminganewyorklawlimiting the number ofhours a baker could work in a week because the public health interest asserted by new york did not outweigh the individual's freedom to contract, which is protected by the due process clause of the fourteenth amendment). 206. /d. at 67. 207. seejacobson, 197u.s.ll (l905);lochner, 198u.s.45(1905). thecourtreleased the jacobson opinion february 20, 1905 and released the lochner opinion on april17, 1905. 208. see gostin, supra note 99, at 288. the author describes the lochner court as "a polit­ ically conservative court [that] struck down a great deal of social and economic regulation." 209. see gostin, supra note 99, at 314 ("since roosevelt's new deal, the court has granted police power regulation a strong presumption of validity even if it interferes with eco­ nomic and commercial life. j. 210. see generally, curtice, 209 f. at 589; albert, 200 n.e. at 688. 211. see discussion supra part iv .a. 354 indiana health law review [vol. 6:325 2. model a trans fat ban after new york city's ban indiana should adopt a statewide trans fat ban that closely resembles new york city's ban. the new york. city ban provides a good model that would allow the indiana general assembly members to craft comprehensive legisla­ tion. initially, the ban should include a trial period, much like in new york city. 212 allot restaurant owners and chefs time to adjust to the new rules with­ out facing penalties, but make sure that health inspections include checks on trans fat use.213 this will encourage compliance without exposing indiana to unnecessary lawsuits due to assessing penalties. the grace period should also include a statewide education campaign about trans fats, their dangers, why indiana decided to ban trans fats from restaurants, and what indiana residents should expect.214 education is especially crucial because indiana currently lacks any substantive health information that comes from the local govern­ ment. 215 furthermore, education may also increase public support for the trans fat ban and thus reduce the risk of lawsuits. the grace period should not last longer than a year and the educational campaign about the dangers of trans fats should be adopted into regular health information produced by indiana • s state and local government institutions. a legislative decision to enact the trans fat ban would have to be written to amend the indiana administrative code. 216 these amendments would in­ clude the definitions, procedures, limitations, and penalties related to the trans fat ban. the mandatory trans fat ban should expressly prohibit any foods that contain more than 0.5 grams of trans fat per serving :from being "stored, distri­ buted, held for service, used in preparation of any menu item or served in any food service establishment.'.217 it is important to define what it means for a food to contain trans fats because the fda allows food manufacturers to in­ clude up to 0.5 grams of trans fats and still claim that there are zero grams of trans fats.218 additionally, the trans fat ban should include requirements for food establishments to keep and store nutritionallabels.219 penalties for violat212. seen.y.comp.codesr.&regs. tit 24, § 81.08(2007)("1njune2005, the depart­ ment launched the trans fat education campaign. the campaign called on all nyc [food ser­ vice establishments] to voluntarily remove [partially hydrogenated vegetable oil] :from the foods they were serving."). 213. see theregul.ationto phase out trans fat, supra note 89 (explaining new york city's three month grace period to allow restaurants to comply with the trans fat ban). 214. see n.y. comp. codes r & regs. tit. 24, § 81.08 (2007) (the ban ''was supported by extensive educational outreach to food suppliers, consumers and to every licensed restaurant in new york city."). 215. see supra discussion part id.a 216. 410 ind. admin. code 7-24(2004)("sanitary standards for the operation ofretail food establishments."). 217. n.y. comp. codes r & regs. tit. 24, § 81.08 (2007). 218. see kassel, 359 u.s. at 520. 219. see n.y. comp. codes r & regs. tit. 24, § 81.08 (2007) ("food service establish­ ments and mobile food unit commissaries shall maintain on site the original labels for all food products."). 2009] awful taste of partially hydrogenated on.. 355 ing the trans fat ban should also be detailed; however, the penalties may have to be included in a separate section of the indiana administrative code. 220 vi. conclusion enacting a trans fat ban statewide in indiana is going to be met with oppo­ sition. individuals who see the ban as a paternalistic form of government will criticize the ban for infringing on their constitutional rights, whereas, others will argue the government is impeding on the free market. the criticisms should be listened to and not overlooked; however, it is important to remember that the state does have the legal authority to enact a trans fat ban. when de­ bating a trans fat ban, indiana legislators do not have to choose between im­ proving the health of hoosiers or avoiding the label of a ''nanny,. state. instead. the proper way to frame the debate is a choice between improving the health of hoosiers or upholding a commercial interest to use a harmful product. despite public resistance to public health regulations, indiana should take the bold leap and enact the ban to take an active part in improving the health and welfare of indiana citizens. removing trans fats is not the cure-all remedy to our health problems, but rather a starting point for indiana to take an active role in battling the epidemic of chronic disease. 220. see 410 ind. admin. code 7-23-1 (2004)(the act detailing the schedule of civil pe­ nalties for violations of the related food establishment code). paging king solomon: towards allowing organ donation from anencephalic infants faza1 khan, m.d., j.d: and brian lea** table of contents i. introduction ..••..•.••...•...•.••.•••...•....•....•....••....••.••..•.•••..••.•••..•.••..•••. 17 n. biology •.•.•••••••••••.•••••••.•••••..•••••...••••...•••....••••.••.••....••••.•...••••••••...••.• 19 ill. the potential use of anencephalic infants as organ donors for other cidldren ..••••••...•••...••••...••••....•••.......•....•.•..••• 21 iv. the dead donor rule: legal restrictions on anencephalic organ donation ••••••••••.•••••.••••••.••••.•••••....•••.....•••..•.•••.....•••...•.••.... 25 v. retiiinking the dead donor rule: potential solutions to a legal problem .............................................................................. 27 a. complete abandonment of the dead donor rule ...................... 27 b. argument that anencephalic children never possess life ....... 28 c. a limited approach qualifying anencephalic infants as an exception to the dead donor rule ........................................... 32 vi. the fear that scientists would intentionally create anencephalic organ donors ..................................................... 34 a. scientists may soon possess the ability to intentionally create anencephalic in.fants .................................................................. 34 b. proposed legal rules to ensure the integrity of the anencephalic organ transplant process ......................................................... 37 1. criminalization of intentional creation of anencephalic human beings ..................................................................... 3 7 2. imposition of strict liability for anyone transplanting organs from intentionally created anencephalic infants .. 40 vll. a possffile socioeconomic implication of anencephalic organ donation ........................................................................... 42 vid. conclusion .................................................................................... 44 i. introduction in october of 1987, canadian doctors artificially sustained the life of an anencephalic infant so that her organs could be transplanted into another child, • assistant professor oflaw, the university of georgia school oflaw; b.a. universi­ ty of chicago; m.d.university oflllinois college ofmedicine; j.d.university oflliinois college of law . .. jd. 2009, university of georgia school of law. 18 indiana healm law review [vol. 6:17 touching off a fiery debate.1 at the request of her parents, doctors connected baby gabrielle, who was born missing most of her brain, to a respirator before flying her to lorna linda, california, where her heart was transplanted into the world's youngest recipient of a heart transplant.2 while baby gabrielle's par­ ents insisted that their daughter's organs be used in this manner and were pre­ sumably happy with the resulting transplant, one of baby gabrielle's doctors expressed qualms about his role in the saga. almost immediately, a firestorm of debate ignited as parents of unborn children with anencephaly began offering their children's organs for use in similar procedures.3 critics quickly began warning of slippery slopes and difficult moral questions.4 this continuing de­ bate calls into question the medical propriety and the usefulness of current med­ ical definitions of death. it also implicates even more fundamental issues, questioning what is required for a life to be considered fully human and also the nature and extent of respect, both legal and medical, warranted by such a life. this article attempts to demonstrate that organ donation from anence­ phalic infants can be both beneficial and morally justifiable. section i dis­ cusses the biological and physical manifestations of anencephaly. section ll introduces the current need for infant organs for transplantation, the possibility that anencephalic organs could address some of that demand, and the basic eth­ ical positions both for and against the allowance of anencephalic organ trans­ plantation. section ill discusses the dead donor rule, the legal obstacle which currently makes anencephalic organ donation legally problematic. section iv discusses possible legal approaches to permitting organ transplants from anen­ cephalic donors: the abandonment of the dead donor rule would cause too many undesirable consequences; the classification of anencephalic infants as non-persons offends society's general ethical norms and creates slippery slope problems that are in the realm of possibility; however, the classification of anencephalic infants as persons born into a state of death permits anencephalic organ donation without denying anencephalic infants personhood status and opening pandora's box. section v lays out legal safeguards necessary to pre­ vent the abuse of an anencephalic organ donation scheme in the event that mankind perfects its ability to intentionally create anencephalic human organ donors. section vi addresses potential class-related social concerns posed by 1. ellen goodman, is this gift of life worth price, cmc. trm., dec. 13, 1987, at 2. 2. sandra blakeslee. baby without brain kept alive to give heart, n.y. times, oct 19, 1987, at ai (describing the story of baby gabrielle and transplant recipient, paul hole). 3. see sandra blakeslee, infant transplant program is halted to reassess issues, n.y. times, aug. 20, 1988, at 17 (noting that, following baby gabrielle saga, "more than 200 parents and physicians representing parents inquired about the possibility of using such babies as organ donors" but that the program was suspended due to "medical, ethical, and emotional difficulties"). 4. peter steinfels, ideas & trends: infant organ plan ends; brief lives, large questions, n.y. times, sept. 18, 1988, at 8 (noting that parents of unborn anencephalic infants "wanted to donate their newborns' hearts and livers to save the lives of other infants" while critics "loudly voiced fears that society was marching into a moral quagmire''). 2009] paging king solomon 19 anencephalic organ donation while arguing that a facially-just transplant policy should not be tainted by independent social problems, such as lack of medical care for the poor. this article concludes by advocating for the sake of infants in need of organ transplants a properly tailored transplant policy allowing par­ ents of anencephalic infants to donate their children's organs for use in trans­ plants. ii. biology anencephaly, "generally defined as the congenital absence of skull, scalp and forebrain,"5 has been described as a "nightmarish neural tube defect,,<; this condition is "characterized by a lack of brain development above the level of the brainstem," and such children often lack a cerebrum, cerebellum, and bones of the skull. 7 the cause of anencephaly remains a mystery to modern science, 8 although there have been studies demonstrating that supplementation with folic acid prior to conception and during the early stages of pregnancy can decrease the chances that a child will be born with anencephaly.9 children suffering from anencephaly, sometimes defined as an "absence of the cerebral hemispheres" and occasionally involving malformation or ab­ sence of portions of the brain stem or spine, often possess a jarring appearance, as "the absent brain is sometimes replaced by malformed cystic neural tissue, which may be exposed or covered with skin. "10 the effects of anencephaly on the newborn sufferer are brutal and swift, as there is "no way to save such a child, which in virtually all cases dies hours after birth. "11 anencephaly is easi­ ly diagnosed through amniocentesis and high-resolution ultrasonography, as the defect typically develops during the first two months of pregnancy.12 the diag­ nosis frequently results in the abortion of such infants, even in those countries 5. d. alan shewmon, anencephaly: selected medical aspects, hastings center rep., oct.-nov. 1988, at ll. 6. graeme stemp-morlock, pesticides and anencephaly, 115 envrl. health persp. a78 (2007). 7. sue a. meinke, anencephalic infants as potential organ sources: ethical and legal issues, 12 scope notes 1, 2 (1989), available at http:/ /bioethics.georgetown.edu. 8. see anencephaly-info, www.anencephalie-info.org (last visited apr. 11, 2008) (follow link to "frequent questions") (noting that no one knows what causes anencephaly, yet stating that parents do not cause anencephaly). 9. see de wals et al., reduction in neural-tube defects after folic acid fortification in canada, 357 new eng. j. med. 135 (2007) (noting that fortification of cereal products with folic acid in canada decreased prevalence of neural tube defects, particularly where that prevalence was previously highest); see also sandeep grover & nitin gupta, lithium­ associated anencephaly, 50 can. j. psychiatry 185, 185-86 (2005) (describing the anecdotal case of a pregnant woman with an anencephalic fetus who took lithium prior to conception). 10. the merck manual of diagnosis and therapy 2222 (mark h. beers & robert berkow eds., merck research laboratories 17th ed.l999) [hereinafter merck manual]. 11. dena kleiman, for a catholic doctor, a crisis of conscience, n.y. times, apr. 22, 1987, at bl. 12. see merck manual, supra note 10. 20 indiana health law review [vol. 6:17 where the procedures remains illegal.13 if not aborted, an anencephalic infant has a high probability of being stillborn; however, this fate is not certain. 14 while one medical dictionary states that anencephaly "is incompatible with life;'15 the fact remains that such infants do on occasion survive past birth to live, in the most basic sense of the word, for a brief period oftime.16 inevita­ bly however, anencephaly results in death, as, while a brainstem alone can maintain the most basic life functions, termed the autonomic functions, for a short period of time, without the rest of the brain breathing fails sporadically, with these failures increasing in frequency until respiration ceases altogether.17 the only remaining question is how swiftly the child's death will come. even during their brief lives, anencephalic infants do not experience or in­ teract with the world in a manner that corresponds with any common view of the human experience. consciousness, in its most basic sense, is ''the state or condition presupposed by any experience whatsoever. ''18 anencephalic child­ ren are "by definition permanently unconscious because they lack the cerebral cortex necessary for conscious thought," rendering them rather similar to those in a persistent vegetative state.19 while lower brainstem functions, including "breathing, blood pressure, temperature, and neuroendocrine control," can con­ tinue for some period of time in the absence of a cerebrum, consciousness and cognition, ''the earmarks of higher brain activity, .. require a functioning cere­ brum. 20 the lack of consciousness of anencephalic infants has major implica13. see maria cristina r. guilam& marilena c.d.v. con&, jwa; medicine and women: a case study on prenatal genetic counseling in brazil, 7 developing world bioethics 78, 79 (2007) (noting that in brazil abortion is a criminal offense, but that in cases of anencephaly and similar defects, social and even judicial opinion has been mixed). 14. harold chen, atlas of gbnimc diagnosis and counseling 721 (humana press 2006) (referring to anencephaly as the most severe of neural tube defects and noting its common association with stillbirth and death soon after birth). 15. taber's cyclopedic medical dicitonary 100 (17th eel. 1993). 16. see first, do no harm, 122 commonweal 4 (1995) (observing that anencephalic babies, when they survive birth, usually die within a few hours or days of their birth); see also merck manual, supra note 10, at 2222 (stating anencephalic infants are not helped by treatment and are either stillborn or die within days or weeks of birth). but see tracy k. koogler, benjamin s. wilfond & lainie freedman ross, lethal language, lethal decisions, 33 hastings center rep. 37, 38 (2003) (describing a case involving an anencephalic infant who survived for approximately two and one half years due to the effects of aggressive care and mechanical breathing assistance provided when her mother refused to terminate such care). 17. see j.l. peabody, j.r. emery & s. ashwal, experience with anencephalic infants as prospective organ donors, 321 new eng. j. med. 344 (1989) (describing the method of death typical of anencephalic infants who survive live birth and stating that such death renders their organs unsuitable for transplantation by time legal requirements for death are satisfied). 18. bjorn merker, consciousness without a cerebral cortex: a challenge for neuroscience and medicine, 30 behav. & brain set. 63, 63-64 (2007) (further defining consciousness as "the •medium' of any and all conscious experience"). 19. in ret.a.c.p., 609 so. 2d 588,590 (fla 1992), as reprinted in janetl.dolgin& lois l. shepherd, bioethics and tile law 838, 839 (aspen 2005). 20. david randolph smith, legal recognition ofneocorticaldeath, 11 corneill. rev. 850, 857 (1986). but see president's comm'n for tile study of enncal problems in medicine and biomedical and behavioral research, defining dea1h: a report on tile 2009] paging king solomon 21 tions for the debate surrounding their use as sources of transplant organs for other infants. ill. the potential use of anencephalic infants as organ donors for otiier children while modem technology has vastly increased mankind's ability to suc­ cessfully transplant organs, the unfortunate fact remains that fewer donors exist than potential recipients oftransplants.21 this quantitative discrepancy between those who need organs and the number of organs available for transplantation is magnified when one focuses specifically on children, as a "severe shortage of transplantable organs exists for infants and children with life-threatening car­ diac, renal, and hepatic disease. "22 when this shortage of organs for children in need of transplants is coupled with the fact that many of the organs needed, such as livers, kidneys, and hearts, "cannot be stored or banked" for later use,23 it becomes apparent that, under the existing system, the demand for organs for transplantation into children will continue to outpace the available supply. the medical community possesses the technology necessary to use anen­ cephalic infants as a source of organs for transplantation into other children.z4 while anencephalic children lack a brain, the rest of their organs typically de­ velop normally, making them physically suitable for use in transplants. 25 the way in which an anencephalic infant dies, however, typically destroys the suita­ bility of that infant's organs for transplantation into other infants; as the anen­ cephalic baby's respiratory processes repeatedly lapse due to its lack ofhigber brain function, its "oxygen-starved organs are so severely damaged that they are no longer suitable for transplantation.'.26 medical professionals, however, can medical, legal, and enncal issues in 1he i>etermination of dea1h 15 (1981) [hereinafter defining deam] (noting that consciousness may not be so easily compartmentalized. that interactions between cerebral cortex and brainstem may create consciousness, and that "the 'higher brain' may well exist only as a metaphorical concept, not in reality''). 21. see charles c. dunham iv, "body property": challenging the ethical barriers in organ transplantation to protect individual autonomy, 17 annals healml. 39 (noting that ''not every person who needs an organ transplant will receive one''); see also united network fororgansharing,http://www.unos.orgl(lastvisitedfeb.15,2008)(statingthatonfebruary8, 2008, 98,080 patients waited for only 13,224 donor organs). 22. robert d. truog, abstract. anencephalic newborns: a source of transplantable organs?, 5 j.intensive care med. 82 (1990), available at http://jic.sagepub.com/cgi/ content/abstract/5/2/82 .. 23. howard s. schwartz, bioethical and legal considerations in increasing the supply of transplantable organs: from uaga to "babyfae," 10am.j.l.&med. 397,398(1985). 24. see supra notes 1-2 and accompanying text. 25: see jeffrey r. botkin, anencephalic infants as organ donors, 82 pediatrics 250, 251 (1988) (noting the rate of malformation of anencephalic infant's organs exceeds that of the general population, "but not to a degree that would preclude their use in transplantation"). but see winnie wai-ving li et al., the eyes of anencephalic babies: a morphological and immunohistochemical evaluation, 1171nt'lj. neuroscience 121, 129-32 (2007) (observing that the eyes of three chinese anencephalic neonates revealed few retinal abnormalities, but that the same eyes exhibited degeneration in corneas, irises, and lenses). 26. jay a. friedman, toking the camel by the nose: the anencephalic as a source for 22 indiana health law review [vol. 6:17 avoid this problem by artificially maintaining the life of an anencephalic new­ born through the use of a respirator and other modem technology so that the infant's organs can be removed while the anencephalic child is still living, or, more accurately, breathing thereby preserving the infant's organs for transplan­ tation.27 such methods have received support from some parents of anencephalic children. 28 in addition, the american medical association ("ama'') approved the harvesting of organs from anencephalic infants in 1995.29 as represented by the story ofbaby gabrielle, 30 such measures could give the parents of anen­ cephalic children the ability to pull some sense of purpose out of the tragedy of giving birth to a child with anencephaly by granting another child the possibili­ ty of a full life. supporters of anencephalic organ donation generally argue that anencephalic organ donation not only provides life to infants in need of organs at little or no expense to the donor, but also provides a sense of meaning to the emotionally distraught parents of an anencephalic child; such donation is, there­ fore, under a hedonistic utilitarian calculus, 31 ''morally justified because it pro­ duces the greatest good for the greatest number of people. "32 not everyone, however, views harvesting the organs of children with anencephaly in such a positive light. the ama withdrew its report proclaiming that the harvesting of organs from anencephalic children was intrinsically moral in the face of widespread criticism in both society and the general medical community. 33 critics typically pediatric organ transplants, 90 cowm. l. rev. 917, 924 (1990). 27. lorna linda university medical center, the hospital which performed the transplant involving baby gabrielle, developed the first protocol addressing the use of anencephalic infants as a source of organs for transplantation. under that protocol, anencepbalic infants were to be kept on life support for up to a week, at which point. if they were not yet brain dead, the support would be removed and they would be allowed to die naturally. anencephalic organ donation comml'i'me of loma linda university medical ci!nter, considerations of anencephauc infants as organ donors: a working document 3-4 (1987) (on file with authors). 28. shewmon, supra note 5, at 15 (observing that "[a]lthough there is [sic] no hard data on the proportion of brain-dead children whose parents are willing to donate their organs, the experience in ucla's pediatric intensive care unit approximates 75 percent" and postulating that when narrowed to anencephalies, this percentage will approach two-thirds). 29. see generally council on ethical and judicial aff:8irs, am. med. ass'n, the use of anencephalic neonates as organ donors, 273 jama 1614 (1995) (basing new policy on grounds that anencephalic infants have no interest in life and that the purposes of the "dead donor rule" were therefore not served by forbidding harvesting of organs from anencephalic newborns). 30. see supra notes 1-4 and accompanying text. 31. utilitarianism is commonly associated with two british philosophers, jeremy bentham and john stuart mill, and ''is referred to as a consequentialist or teleological approach to morals because actions are judged by their results" rather than the principles of the actor. janet l. dolgin & lois l. shepherd, bioe1liics and die law 14-15 (aspen publishers 2005). a utilitarian outlook views an act as justified if it results in a net increase ofhappiness or pleasure. i d. 32. beth brandon, anencephalic infants as organ donors: a question oflife or death, 40 case w. res. l. rev. 781,800-01 (1990). 33. dolgin & shepherd, supra note 31, at 153 (observing that while the issue itselfhas 2009] paging king solomon 23 base their argument against the use of the organs from anencephalic infants for transplantation on the sanctity-of-life doctrine. this theory tends to disregard the quality oflife issues frequently cited in utilitarian arguments, instead focus­ ing on the belief that all human life is sacred even those burdened with the most severe handicaps known to medicine and that every life should therefore be sustained.34 the sanctity-of-life doctrine can often be found entwined with ar­ guments citing immanuel kant's categorical imperative, which "calls for hu­ mans to be treated as ends in themselves, and never solely as a means to an end."35 finally, those opposing the use of anencephalic infants as organ donors argue that to proceed toward such a policy is to risk falling down a slippery slope of ever worsening consequences. 36 the use of anencephalic infant organs for transplantation implicates two "very influential normative ethical views'o37 at the heart of most bioethical and philosophical debates: utilitarianism is often advocated by those in favor of the use of anencephalic organ donors, whereas kantianism, expressing a deontolog­ ical viewpoint, is often embraced by those opposing the practice. 38 given the chasm that exists between these divergent points of view, the level of consensus necessary to change the law regarding organ donation by anencephalic infants seems unlikely to exist in the near future. 39 supporters of anencephalic organ donation can nevertheless make a strong argument that such donation satisfies both utilitarian and kantian normative requirements. receded in importance due to pre-birth diagnosis and abortion of many anencephalic infants, the issue remains important due to its influence on debates concerning patients in persistent vegetative states). 34. see lois shepherd, in respect of people living in a permanent vegetative state­ and allowing them to die, 16 healm matrix 631, 671 (2006) (listing the sanctity-of-life doctrine as among arguments advanced by those who support feeding of patients in persistent vegetative states in absence of patient's wishes). 35. john d. arras & shlomo shinnar, anencephalic newborns as organ donors: a critique, 259 j. am. med. ass'n. 2284, 2284 (1989). 36. see lisa e. hanger, the legal, ethical, and medical objections to procuring organs from anencephalic infants, 5 healm matrix 347, 356 (1995) (noting that "[c]onsidering anencephalic infants 'dead' or 'close enough to death' instills in the public a fear that other individuals very near death also will be declared dead and will be killed for the sake of procuring their organsj. 37. anders nordgren, responsible genetics: 'file moral responsmility of geneticists for tile consequences of human genetics research 25 (kluwer acad. publishers 200 i). 38. see supra notes 31-34 and accompanying text. 39. the practical reality is that whether or not the organs of anencephalic donors are utilized depends entirely on the laws regarding organ donation. while bioethical and philosophical arguments will necessarily be used by whatever side eventually wins the debate over this issue, the arguments in and of themselves will not have a practical effect without a change in the actual law, and "until there is a consensus that these standards should be changed. anencephalic infants cannot and should not be used as sources for donor organs." jennifer s. bard, the diagnosis is anencephaly and the parents ask about organ donation: now what? a guide for hospital counsel and ethics committees, 21 w. new eng. l. rev.49, 94 (1999). see generally david orentlicher, commentary, organ retrieval from anencephalic infants: understanding the ama 's recommendations, 23 j.l. med. & ennes 401 (1995) (reinforcing the idea that law trumps ethics opinions and pointing out that an ethics opinion regarding anencephaly expressly declared that its implementation was subject to governing law). 24 indiana heal1h law revlew [vol. 6:17 making use of the organs of anencephalic infants for transplantation pur­ poses is consistent with a strictly utilitarian calculus because other than the do­ nor, who some argue possesses no or only a slight interest in the matter,40 "all human parties concerned stand to receive great benefit," including the trans­ plant recipient, the transplant recipient's parents, and the parents of the donor.41 while some argue that such a utilitarian conclusion fails to take into account the potentially far reaching consequences of endorsing transplants from anen­ cephalies and thereby risks a rapid descent down a slippery slope, such a risk can be avoided by framing any justification for harvesting anencephalic organs in the most narrow way possible to maintain a clear limiting principle on the logic involved.42 transplantation from anencephalic infants is, therefore, con­ sonant with a raw utilitarian perspective, as "[ u ]tilitarianism demands that the greatest number of persons benefit from the anencephalic infant's organs, even if it means changing the present legal definition of death to include infants with anencephaly. "43 the greatest challenge to the use of organs donated by anencephalic in­ fants lies in the form of accusations that such a practice would violate k.antian­ ism, a "bedrock principle ofwestem ethics,'' by failing to treat such children as an end in themselves and denying them their humanity.44 some answer this assertion with the claim that "(r]espect for the essential worth oflife ... is not an absolute value in the sense of overriding all other values'"'5 so that a strong enough balancing of utilitarian factors in favor of allowing anencephalic organ donation could override k.antian concerns about the practice. such an ap­ proach, however, unconvincinglj attempts to sidestep the k.antian issue by ap­ pealing to a utilitarian formulation. others argue that k.antian logic does not apply in the case of anencephalic infants, as kant "did not have in mind non­ self-aware humans. ,,46 similarly, some argue that anencephalic infants should qualify medically 40. the absent or low interest in life of an anencephalic infant has also been cited as a justification for refusing any treatment beyond palliative care to anencephalies. such an argument asserts that provision of care to anencephalic infimts is both quantitatively and qualitatively futile. ''quantitatively, it is futile because an anencephalic ... will die soon no matter what physicians do. qualitatively, it is futile because they will never be conscious or enjoy any form of human experience." e. haavi morreim, futilitarianism, exoticare, and coerced altruism: the ada meets its limits, 25 seton hall l. rev. 883, 886 (1995). 41. ethics and social impact committee. anencephalic infants as sources of transplantable organs, hastings cen1er rep., oct.-nov. 1988, at 29. 42. see infra notes 83-88 and accompanying text. 43. joseph n. harden, the "gift" of life: should anencephalic infants die to serve noble goals?, 27 cumb. l. rev. 1279, 1302 (1996). 44. j.c. willke&daveandrusko,personhoodretba,hasnnoscenterrep.,oct.-nov. 1988, at 31. 45. harden, supra note 43, at 1309. 46. j. steven justice, casenote, personhood and deajh-the proper treatment of anencephalic organ donors under the law: in ret .a.c.p ., 609 so. 2d 588 (fla. 1992)., 62 u. cin. l. rev.1227, 1261 (1994). 2009] paging king solomon 25 as being "dead,'.47 and thus kantian principles would not bar harvesting organs from a non-living infant. making this point could move society closer to the consensus required to change the current state of the law, thereby opening the channels through which much needed organs could be acquired from infants with anencephaly for use in children needing transplants. a proper legal ap­ proach to anencephalic organ transplants must adhere to and reinforce society's ethical values without upsetting beyond the extent necessary the current legal approach to organ transplantation. n. the dead donor rule: legal restrictions on anencephalic organ donation the "dead donor rule" states simply that "it is immoral to kill patients by taking their organs,'.48 meaning that a patient's organs should not be removed until that patient has been declared legally dead.49 how doctors apply this rule in a practical setting has obvious implications for the effectiveness of transplant procedures. as any transplant surgeon could tell you, "we cannot transplant organs that have begun to decompose or grow necrotic; thus, we must deter­ mine the death of the human being very quickly when organ donation is de­ sired."50 thus, the definition of death used by the medical professional making the determination of death becomes extremely important in a transplant setting. the common law generally defined death according to "two easily ob­ servable and universally familiar touchstones, namely, a permanent absence of bloodflow and breathing."51 this cardiopulmonary definition of death though traditionally widely accepted as a bright-line rule has come into disfavor as it "minimizes the possibilities of successful organ transplantation by discouraging physicians, due to their fear of possible criminal or civil liability, from remov­ ing the donor's organs until after respiration and heartbeat have ceased and the organs have begun to deteriorate. "52 under the strict cardiopulmonary standard of death, an anencephalic child undoubtedly qualifies as alive until complete respiratory cessation, at which point the child's organs would be useless for transplantation. 53 such a result would preclude the use of anencephalic infants 4 7. see infra notes 89-1 02 and accompanying text. 48. elyssa r. koppelman, the dead donor rule and the concept ofdeath: severing the ties that bind them, 3 am. j. bioenncs i (2003) (noting further that the dead donor rule attempts to balance deontological and utilitarian concerns). 49. see generally robert m. arnold & stuart j. youngner, the dead donor rule: should we stretch it, bend it, or abandon it?, 3 kennedy lnst. ennes j. 263 (1993) (discussing the dead donor rule, including critiques of the rule and its future). 50. james dubois, abstract. avoiding common pitfalls in the determination of death, 23 issues l. & med. 204, 204 (2007). 51. jason l. goldsmith, wanted! dead and/or alive: choosing among the not-so­ uniform statutory definitions of death, 61 u. miami l. rev. 871,879 (2007). 52. thomas r. trenkner, annotation, tests of death for organ transplant purposes, 76 a.l.r.3d 913 (1977). 53. see d. scott bennett, comment, chimera and the continuum of humanity: erasing 26 indiana health law review [vol. 6:17 as organ donors; however, cardiopulmonary failure no longer monopolizes the definition of death, as legislatures have taken measures to keep up with evolv­ ing medical knowledge of the dying process. most states have now adopted the uniform determination of death act (the "act"), 54 which specifies that an "individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead" and that such a "determination of death must be made in accordance with ac­ cepted medical standards. "55 while this statute allows death, defined in the united states as the "moment at which the bodies physiological system ceases to constitute an integrative whole,'.s6 to be determined in the traditional com­ mon law cardiopulmonary fashion, the rule also incorporates an alternative me­ thod of determining death in the form of total or whole brain death. in other words, for the purposes of determining death under the act, the "ability of other parts of the body to function via life support is not relevant if the brain has completely failed. "57 the ability to define death as whole brain death has rendered organ trans­ plantation much more feasible in many cases. if a patient fails a battery of tests designed to detect brainstem function and it is determined that the patient has no spontaneous ability to breathe, then the patient is declared dead, and, if an organ donor, "taken to the operating room for organ recovery and transplanta­ tion, while mechanical ventilation is continued and with the beating heart still perfusing the patient's organs. "58 in short, at least in most situations, the whole brain death standard satisfies the dead donor rule while allowing the donor's organs to be preserved for transplantation. unfortunately for children in need of organs, the neurological definition of death embraced in the act does not apply easily to newborns in general and anencephalic infants in particular. to begin, doctors typically have great diffi­ culty determining ifbrain death has occurred in newborn children since "infants may later develop brain functions that they do not have at birth,'.s9 a fact which has led some thinkers to call upon doctors to wait seven days before making a the line of constitutional personhood, 55 emory l.j. 347, 368 (2006) (observing that the common law definition of death does not include those with ''total, irreparable loss of higher­ level brain function but with some continuing respiratory and cardiac functions"). 54. see jason m. horst, the meaning of "life": the morning-after pill, the question of when life begins, and judicial review, 16 tex. j. women & l. 205,223-24 (2007) (arguing that states have passed the uniform determination of death act in an attempt to achieve universality). 55. unif.determinationofdeathacr§ 1 (1980), 12au.l.a386,§ 1 (west1980& supp. 2003). 56. defining death, supra note 20, at 33. 57. bennett, supra note 53, at 369. 58. robert d. truog, brain death-too flawed to endure, too engrained to abandon, 35 j.l. med. & ennes 273,273 (2007). 59. joseph j. volpe, brain death determination in the newborn, 80 pediatrics 293, 294-95 (1987). 2009] paging king solomon 27 determination ofbrain death in a newborn.60 to begin, doctors typically have great difficulty determining ifbrain death has occurred in newborn children since "infants may later develop brain func­ tions that they do not have at birth,'o61 a fact which has led some thinkers to call upon doctors to wait seven days before making a determination of brain death in a newborn. 62 in addition to the problems inherent in making a neurological determination of death in a newborn, anencephalic newborns pose special diffi­ culties under such a standard. a child with anencephaly,like a person in a per­ sistent vegetative state, entirely lacks cognitive abilities, and yet nevertheless maintains spontaneous cardiac and respiratory function, at least sporadically, during his or her brieflife.63 this maintenance ofbasic life functions, includ­ ing respiratory functions, is due to the functioning of the brain stem in an anen­ cephalic infant.64 therefore, anencephalic infants do not meet the requirements of either prong of the act; ''while their brain stems function, they do not meet the legal standards for death't65 and therefore will not be able to serve as organ donors until their organs are too deeply damaged to be of use. consequently, in order to enable the use of the organs of anencephalic infants, medicine and the law must embrace a new approach to the dead donor rule. v. rethinking the dead donor rule: potential solutions to a legal problem a. complete abandonment of the dead donor rule some thinkers advocate that the dead donor rule should be abandoned and replaced with a regime in which "individuals who desire to donate their organs and who are either neurologically devastated or imminently dying should be allowed to donate their organs without first being declared dead.'t66 those who 60. task force for the determination of brain death in children, guidelines for the determination of brain death in children, 37neurology 1077,77-78 (1987). 61. joseph j. volpe, brain death determination in the newborn, 80 pediatrics 293, 294-95 (1987). 62. task force for the determination of brain death in children, guidelines for the determination of brain death in children, 37 neurology 1077, 77-78 (1987). 63. see multi-soc'y task force on pvs, medical aspects of the persistent vegetative state-first of two parts, 330 n. eng. j. med. 1499, 1501-03 (1994) (listing forms of permanent unconsciousness, including persistent vegetative state, coma, end stages of degenerative neurological conditions, and anencephaly). 64. john-anderson l. meyer, " 'tis a consummation to be devoutly w"rshed:" towtll'"lb consistency in end-of-life treatment decisions for comatose adults and imperiled newborns, 10 mich. st. u.j. med. & l. 321, 335 (2006). 65. mary crossley, infants with anencephaly, the ada, and the child abuse amendments, 11 issues l. & med. 379, 383 (1996) (noting that anencephalic infimt is not dead until brain stem functions cease, but that natural death damages organs through process of oxygen deprivation). · 66. robert truog & walter m. robinson, role of brain death and the dead donor rule in the ethics of organ transplantation, 31 :9 crmcalcaremed. 2391,2391 (2003), available 28 indiana health law review [vol. 6:17 support the demise of the dead donor rule point to what they view as inherent flaws in the application of the rule, including the present inability to accurately assess total brain death and the disconnect between medical and popular defini­ tions of death. 67 also, opponents of the dead donor rule claim that the rule fails to inquire into whether the potential donor is being respected as a person, focus­ ing instead on whether the patient in a suspended state is dead or alive. 68 har­ vesting organs from anencephalic infants obviously would provide no difficulty under a regime in which the dead donor rule no longer exists; however, aban­ donment of the dead donor rule could have dangerous consequences and is un­ likely to gain any degree of public support. an outright abandonment of the dead donor rule seems unlikely in light of the fact that the '"standard view' is that all human beings have the right to life exactly because they are living human beings and therefore have full moral sta­ tus." therefore, "[t]aking organs would, on this view, be taking the life of a human being. '.69 it appears that most people believe that harvesting organs be­ fore death is immoral and would find any attempt to abandon the dead donor rule undesirable. 70 abandonment of this rule might even pose purely pragmatic problems, as it would likely discourage some people from becoming organ do­ nors. 71 the dead donor rule, despite its potentially sweeping breadth, provides a desirable safeguard in favor of protecting human life. any efforts made to gain widespread acceptance for harvesting organs from anencephalic infants should not try to undermine the dead donor rule entirely. instead, any proposed change to the law should engage the rule according to its own terms to show that the dead donor rule should not be considered violated by the act ofharvest­ ing organs from anencephalic infants. b. argument that anencephalic children never possess life some argue that anencephalic children do not qualify as alive, but are in­ stead non-persons, and that the dead donor rule should therefore not apply to them. 72 those advocating such an approach would modify the dead donor rule atwww.ccmjournal.com/ptlre/ccmlabstract.00003246-200309000-00019.htm. 67. norman fost, reconsidering the dead donor rule: is it important that organ donors be dead?, 14.3 kennedy inst. ennes j. 249, 249-51 (2004). 68. koppelman, supra note 47, at 1. 69. ari robin joffe, the neurological determination of death: what does it really mean?,23 issuesl.&med.l19,138(2007). 70. see generally m. potts & d.w. evans, does it matter that organ donors are not dead? ethical and policy lmplicatwns, 31 j. med. ennes 406 (2005){arguing that brain death is not death and that removal of organs from living. but comatose, patients is immoral, as it kills patients, and contrary to the nature of medical practice). 71. see jerry menikofl: the importance of being dead: non-heart-beating organ donation, 18 issues l. & med. 3, 12 (2002) (postulating that if the dead donor rule were abandoned, some potential donors might reftain from becoming donors due to fear that doctors would be overeager to use their organs for transplants while they were still alive). 72. this approach is sometimes rephrased to indicate that anencephalic infants, though alive, have no interest in life due to their lack of consciousness and that they should therefore be exempted from the dead donor rule, as their protection does not further its purposes. the two 2009] paging king solomon 29 to render it "true by definition," retaining the dead donor rule but increasing the categories of patients considered dead to include those, such as anencephalic infants, without higher brain function.73 according to this view, ''the relevant brain functions for defming life are higher-level consciousness and cognition," so that "[h ]umans who lack the capacity for brain function, either because of congenital defect or subsequent brain death, illustrate that a capacity for brain function is necessary for legal life and therefore legal personhood."74 under such a view, anencephalic neonates do not possess life, or even potential life, and do not require life's attendant legal protections, because "[a]ll rights enu­ merated in the constitution and the bill ofrights are predicated on conscious­ ness, or the capacity for consciousness, except for the right to life itself, which becomes meaningless when consciousness can never exist.'m this view classi­ fies anencephalic infants as not alive, and never having been alive despite their heartbeat, 76 due to their lack of existing consciousness and capacity for future consciousness. therefore, doctors may, under such a regime, freely use anen­ cephalic infants as organ sources without fear of violating the dead donor rule. a regime declaring anencephalic infants to be deceased from conception poses many difficulties, and seems unlikely to gain any degree of general ac­ ceptance. in several instances, courts have made it clear they do not view anen­ cephalic infants as legally dead from the outset of their existence despite recognizing that anencephalic children do not possess consciousness. in in re t.a. c.p., the supreme court of florida found "no basis to expand the common law to equate anencephaly with death," despite explicitly recognizing that anencephalic infants lack consciousness and, according to general medical opi­ nion, the capacity to suffer. 77 similarly, in in re baby k, the fourth circuit court of appeals refused to treat an anencephalic child as dead, despite her statements have the same result, but refusal to deem such infants to be without life seems less cold and more consistent with the general public's view regarding such infants. see council on ethical and judicial affairs, am. med. ass'n. supra note 29, at 1615 (referring to such infants as alive, but lacking any interest in life due to their lack of consciousness). 73. see robert m. veatch, abandon the dead donor rule or change the definition of death?, 14.3 kennedy inst. enucs j. 261,262-66 (noting public perception of death differs from usual assumptions behind dead donor nde, and that sizeable minority of individuals polled would act inconsistently with dead donor rule altogether under its current definition). see also robert m. veatch, the dead donor rule: true by definition, 3 am. j. bioetiucs 10, 10-11 (2003) (defending the dead donor rule but arguing in :favor of expanding the definition of death). 74. bennett, supra note 52, at 369-70. see generally jessica berg, of elephants and embryos: a proposed framework for legal personhood, 59 hastings l.j. 369(2007) (noting that legal or juridical personhood can differ from standard assumptions about personhood and arguing that legal personhood standards may now be more useful than standard definitions of personhood). 75. ronald e. cranford & david randolph smith, consciousness: the most critical moral (constitutional) standard for human personhood, 13 am. j.l. & med. 233,247 (1987). 76. wolfgang holzgreve et al., kidney transplantation from anencephalic donors, 316 new eng. j. men. 960 (1987). 77. in re t.ac.p., 609 so. 2d at 595 (findingthatthelackofconsensus on the issue of whether or not anecephalic infants are alive outweighed the possibility of saving some infants' lives by allowing organ harvesting from anencephalic infants who do not meet the traditional definition of death). 30 indiana healm: law review [vol. 6:17 complete lack of consciousness, and instead ordered a hospital overriding the hospital's belief that life-sustaining treatment was inappropriate to provide treatment to the anencephalic child at the mother's insistence.78 this reluctance to view anencephalic children as non-persons does not stem from mere judicial conservatism; however, as such judicial views draw their force from societal opinion. many feel that "any attempt to include anencephalic infants as pennissible living organ donors is completely inconsistent with societal mores" because "[t]o redefine infants with anencephaly as being 'born dead' would be tanta­ mount to labeling them as 'non-persons,"'79 a leap many are unwilling to take. 80 this view derives largely from a general societal concern with respect for life, and is premised on the belief that "[t]o allow removal of the anencephalic in­ fant's vital organs before legal death would allow the active killing of a human being ... [contravening] the current legal prohibition against active killing .• .st proponents of this view argue that anencephalic infants possess life, and to kill them is infanticide, 82 whether or not their killers intend their deaths to benefit others. society's belief that anencephalic newborns possess life worthy of respect stems from well-entrenched value systems, including conservative approaches to major world religions. 83 observation of anencephalic infants can, in certain 78. when baby k was born with anencephaly, her doctors put her on a ventilator in order to confirm their diagnosis. against the doctors' advice, baby k's mother refused to accept a palliative care regimen, instead insisting on life sustaining care whenever her child had trouble breathing. baby k wound up in a nursing home. but occasionally had to be admitted to a hospital to stabilize her breathing. the case arose out of the hospital's eventual attempt to refuse to provide such treatment the 4th circuit held for the mother, granting anencephalic baby k the same treatment as any other child would get in the circumstances. in re baby k, 16 f.3d 590, 597-98 (4th cir. 1994), cert. denied 513 u.s. 825 (1994). 79. debra h. berger, the !tifant with anencephaly: moral and legal dilemmas, 5 issues l. & med. 67, 83-85 (1989). 80. one argument for the inclusion of anencepbalic i.nfimts within the category ofliving persons says that. despite the defects stemming from anencephaly, such infants "possess a sufficiently vast amount of human phenotypical traits for one ... to view them as human children." the argument continues that. as human children, they should be covered by moral principles prohibiting intentional killing. alfonso 06mez..lobo, lnviobility at any age, 17 kennedy inst. enncsj. 311,319 (2008). 81. committee on bioethics, infants with anencephaly as organ sources: ethical considerations, 89 pediatrics 1116, 1118 (1992). 82. stephen w. smith, the killing of severely disabled newborns: the spectre behind the legislation of physician assisted suicide and euthanasia, 24 med. & l. 791, 796 (2005) (listing anencephalic infants among severely disabled infants likely to be victims of infanticide). 83. see avraham steinberg, medical-halachic decisions of rabbi shlomo zalman auerbach (191()..1995), 3 jewish med. ennes 30,35 (1997) (describing jewish rabbi's view that taking organs from anencepbalic infant while spontaneous respiration continues constitutes murder), available at http://www .medethics.org.ivarticles/jme/jmeb2/jmeb2.l.asp# _ ftnref 39; botkin, supra note 25, at 254 (noting the principle of preserving life at all costs is rooted in judeo-christian theology and forbids taking human life. even for benefit of others). see also b. larijani & f. zahidi_, changing parameters for abortion in iran, 141ndian j. med. ennes 130 (2006) (noting iran, in its enactment of islamic law, bans abortion after ensoulment. which occurs during pregnancy, which would presumably preclude retrieval of organs ftom 2009] paging king solomon 31 situations, reinforce this societal view that such infants possess life in a tradi­ tional sense. for instance, despite the lack of higher brain functions, which would enable an infant to process a good or bad taste (or suffering for that mat­ ter), some anencephalic infants exhibit responses, including recognizable facial expressions, as a reaction to taste stimuli. 84 these reactions to stimuli do not necessarily indicate life in a medical sense, yet such realities cause many people to revolt at the idea of deeming anencephalies to be anything less than human. 85 society, therefore, would not likely embrace a view that anencephalic infants never possess human life due to their lack of consciousness. perhaps the strongest reason for refusing to deem anencephalic infants to be dead in the womb lies in the form of a slippery slope. 86 "the slippery slope is real" and should not be discounted, as some physicians have in the past pro­ posed transplants from infants with defects that fall short of the severity of anencephaly. 87 these proposals garner any plausibility they might have from the fact that ''[ s ]orne of the arguments for allowing organs to be taken from anencephalic infants apply equally to other permanently unconscious patients, including infants with hydraencephaly and some with microencephaly."88 in­ deed, following the baby gabrielle saga, while lorna linda university was seeking anencephalic infants as sources of organ transplants, some referrals to the program were made by doctors of patients who did not have anencephaly, but rather some lesser malady, including one child who was neurologically in­ tact but lacked functioning kidneys. 89 this slippery slope could even extend beyond the realm of newborns, potentially reaching those who were once con­ scious but have since entered a persistent vegetative state, as anencephaly re­ sembles a persistent vegetative state in that "[b ]oth conditions leave affected individuals entirely devoid of cognitive abilities or awareness but with spontaanencepahlic infants already birthed). 84. michael berger, a model of proverbial social development and its application to social dysfunctions in autism, 41:3 j. child psychol. & psychiatry 338, 339 (2006). these facial indications strike many as indicative of at least some level of life, and this view is supported, albeit in a backhanded way, by the statement that the brain stems of anencephalic infunts "do not differ substantially .from the brain stem of a fish, [and such infunts therefore] have more in common with a fish than a person." sabra chartrand, legal definition of death is questioned in florida infant case, n.y. times, mar. 29, 1992, § 1, at 12. as a fish lives, this quote supports the idea that so too do anencephalic infunts. 85. see tom nolan, .. . and god will make him a cake, human life rev., winter2007, at 58 (describing a personal encounter with an anencephalic grandchild with the phrase "he was a little boy, not an it"). 86. but see sadath a. sayeed, the marginally viable newborn: legal challenges, conceptuallnadequacies, and reasonableness, 34 j.l. med. & ennes 600, 609 (2006)("[a]s most practicing physicians know, perhaps unlike some practicing bioethicists, the real moral slope is coated with the thickest molasses in these life and death matters."). 87. brandon, supra note 32, at 802. 88. committee on bioethics, supra note 79, at 1118 (noting that the argument that anencephalic infants are dead due to lack of consciousness and cognitive capacities reaches to all permanently unconscious patients). 89. d. alan shewmon et al., the use of anencephalic infants as organ sources, 261 jama 1773, 1775 (1989}. 32 indiana health law review [vol. 6:17 neous cardiac and respiratory functions. "90 therefore, bioethicists should not disregard the potentially large consequences of failure to heed the slippery slope argument. · without a clear limiting principle, there is cause for concern with any dec­ laration that anencephalic infants never possess life due to their lack of con­ sciousness from birth and their lack of capacity for consciousness at any point in the future. this slippery slope could even transcend the issue oftransplanta­ . tion, as the eventual solution to the controversy surrounding the use of anencephalic infants as organ sources could have implications for other bioethical and legal debates that generate intense emotion and fierce argumentation. as r. alta charo argues, the parties in the abortion debate "search for proxy wars, using debates on research involving human embryos, the donation of organs from anencephalic neonates, and the right of persons in a persistent vegetative state to die as opportunities to rehearse arguments on the value ofbiologic but nonsentient human existence."91 given the possible implications of a wide sweeping announcement that anencephalic infants meet the criteria of being dead prior to birth, a more limited method of justifying the use of anencephalic infants as organ sources seems morally, and less importantly, practically, neces­ sary in light of the dead donor rule. c. a limited approach qualifying anencephalic infants as an exception to the dead donor rule a more tenable approach towards classifying anencephalic infants in light of the dead donor rule would be to consider them "brain-absent" to a degree sufficient to justify their treatment as brain dead. 92 this approach, in essence, argues that "because anencephalic infants lack integrated brain function and will inevitably die within a short period of time, they are conceptually very close to being brain dead individuals--close enough to be considered brain dead."93 such an approach would result in the creation of an entirely new cate­ gory ofbrain death filled by anencephalic infants, so that any infant diagnosed as anencephalic, and only those infants diagnosed as anencephalic, would qualify as legally dead under the new category. 94 doctors would have little dif­ ficulty implementing such a standard since diagnoses of anencephaly are "al­ most never ambiguous,"9s due to the unique physical manifestations of 90. barbara noah, comment. politicizing the end of life: lessons from the schiavo controversy, 59 u. miami l. rev. i 07, 109 (2004). 91. r. alta charo, the celestial fire of conscience-refusing to deliver medical care, 352 new eng. j. med. 2471,2472 (2005). 92. m.r. harrison. the anencephalic newbom as organ donor,iiastingsci!ntbrrep., apr. 1986, at21-23. 93. committee on bioethics, supra note 79, at 1118. 94. see norman post, removing organs from anencephalic infants: ethical and legal considerations,16clinj:csinperlnatology331,334(1989). 95. kathleen l. paliokas,anencephalicnewboms as organ donors: an assessment of 2009] paging king solomon 33 anencephaly. this view acknowledges that anencephalic infants possess life, and there­ fore does not try to classify them as non-persons. instead, it recognizes that "[a ]ll anencephalies begin to die as soon as they are born. "96 while the differ­ ence between this theory and the theory that anencephalic infants never possess life might seem like mere semantics, there are differences in the resulting impli­ cations of the two views. the view that anencephalic infants do possess life, but immediately begin to die at birth, avoids slippery slope pitfalls inherent in the theory classifying the permanently unconscious as dead while remaining more in line with widespread views about personhood than pronouncements that anencephalic infants do not ever possess life. regardless of whether one views the onset of death as a process,97 or an event, 98 the relevant inquiry for making a determination of death should focus on death as a state, as such a view allows determinations of death to occur in a functional manner that not only is consistent with most religious and philosophical characterizations of death, but that also meets the needs of law and medicine for a definition of death. 99 instead of arguing that anencephalic infants never live or lack an inter­ est in life due to their lack of consciousness this view asserts that anencephalic children, though born alive, immediately begin to die, as evidenced by their complete lack of cognitive potentiali~ and imminent physical death, typically occurring within three days ofbirth. 1 thus, they enter a state of death as soon as they enter the world.101 this view does not attempt to deny the personhood of anencephalic infants, which would be hard to justify in light of the heartfelt views of many that such infants are persons. yet at the same time, this view satisfies the requirements of the dead donor rule, 102 thereby ensuring that the valuable organs of these small donors do not remain permanently off-limits.103 "death" and legislative policy, 31 wm. & mary l. rev. 197, 200 (1989). 96. /d 97. see baruch a. brody, how mmch of the brain must be dead?, in 1hedbfinmon of dea1h: contemporary controversies 71 {stuart j. younger et. al. eds., 1999) (defending the view that death occurs as a process). 98. see j.l. bernat, c.m. culver & b. gert, on the definition and criterion ofdeath, 94 annals internal men. 389 (1981) (expressing the view that death occurs as an event). 99. james m. dubois, is organ procurement causing the death of patients?, 18 issues l. & men. 21,23 (2002). 100. see alasdair g.w. hunter, brain and spinal cord, in humanmalformationsand related anomalies 715, 737 (roger e. stevenson & judith g. hall eds., oxford univ. press 2005) (noting that fifty-eight percent of anencephalic children born alive suffer physical death within three days ofbirth). 101. committee on bioethics, supra note 79, at 1118. 102. see dubois, supra note 50, at 204 ("the key question that should be asked before organ procurement is, 'is this body in a state of death?' if the body is in such a state, then the question ofkilling via organ procurement is moot. because killing involves causing someone to enter the state of death."). 103. i merely argue here that such a position appears more likely than available alternative approaches to both define anencephalic infimts as dead and accord them the personhood status to which most of society feels they are entitled. undoubtedly, there will be critics who will argue in favor of maintaining the brightline definition of death embodied in current law and will likely state that a "dying person is still alive" and that a "prediction that death will occur soon is 34 indiana health law review [vol. 6:17 an approach centered on the brain absence and imminent physical death of anencephalic infants avoids the slippery slope concerns inherent in a broad­ sweeping declaration that anencephalic infants, due to their lack of potential for consciousness, never qualify as alive in the first instance. if the medical profes­ sion or law begins to treat anencephalic infants as inherently devoid of life, the fear is that "doctors, legislators, or the courts could use the same rationale to declare others dead for the same purposes, including persons in a persistent ve­ getative state and possibly infants with other severe birth defects."104 under a more limited approach focused on the specifics of anencephaly, this fear is not present. as the permanently unconscious, whether through defect or through injury, do not face imminent bodily or cellular death, they would not qualify as brain dead under an approach that focused on the unique aspects of anencepha­ ly, namely lack of potentiality for consciousness and imminent physical death soon after birth, in classifying such individuals as in a state of death.105 there­ fore, the limited approach cuts off the slippery slope before it can start sliding. in addition to avoiding today's slippery slopes, a legal framework for anence­ phalic organ transplantation should also address the potential problems imposed by tomorrow's scientific developments. vi. the fear that scientists would intentionally create anencephalic organ donors a. scientists may soon possess the ability to intentionally create anence­ phalic infants any regime set up to allow organ donation from anencephalic infants must address not only the bioethical concerns obvious today, but also those concerns that will likely be raised by technological developments in the future. while it might sound like science fiction, the basic technology to intentionally create anencephalic organ donors has already been developed-the question is whether scientists will attempt to perfect it for human application. scientists have identified the genes responsible for neural tube defects, including exence­ phaly, a condition in mice roughly equivalent to human anencephaly.106 taking these findings a step further, researchers at the university oftexas successfully created headless mice, whose bodies were otherwise correctly formed, by elinot the same as being already dead." paul a byrne et al., anencephaly-organ tranaplantation?, 9 issues l. & med. 23, 33 (1993). the case of the anencephalic infant, however, does not fit so neatly into current concepts of death, a fact which would be of little importance, but for the issue of transplantation. 104. justice, supra note 46, at 1264. 105. r.d. truog & j.c. fletcher, anencephalic newborns: can organs be transplanted before brain death?, 321 new eng. j. med. 388,388-91 (1989). 106. see generally diana m. jurloff & muriel j. harris, mouse models for neural tube closure defects, 9.6 human molecular gmmncs 993 (2000) (relaying findings indicating responsibility of particular genes for neural tube defects in mice and indicating that genes identified in mice with neural tube defects have potential homologues in humans). 2009] paging king solomon 35 minating a particular gene, known as liml, from the embryonic stem cells of the mice. 107 as the gene in question belongs to the homeobox group of genes, which are "essential for embryonic development'' and "present in all ani­ mals,"108 this discovery possesses a potentially vast, inter-species reach. 109 in other words, just as the cloning of the sheep "dolly" revealed to the public that the trajectory of cloning technology was not far from intentionally cloning hu­ mans, such is the moment with developmental biology. not long after scientists demonstrated the ability to intentionally create these headless animals, they began to theorize that, "[b ]ecause the genetic me­ chanisms that control [animal] development are very similar to those that lay down the human body plan it will be possible "to suppress the development of the [human] embryo."110 some have long hoped for similar possibilities, that after suppression or modification of the proper genes, a human fetus "could then be grown as a brain-dead body for spare parts. "11 1 due to its lack of a ca­ pacity for consciousness, the brain-dead human fetus would potentially be una­ ble to suffer harm.112 these creatures would in essence be "cannibalized for spare parts."113 some celebrate the development of headless animals, for if such tech­ niques were perfected to create headless humans, many of the factors that inhe­ rently limit the efficacy of anencephalic organ donation would disappear in the face of a potentially abundant supply of intentionally created anencephalic or­ gan donors.114 indeed, one of the requirements for creating a successful trans­ plant program is repetition, which requires a sufficient volume of cases. this is why larger transplant centers, such as the mayo clinic, have better transplant success rates than smaller, regional programs.115 a larger supply of anence107. see w.w. shawlot & r.r. behringer, requirement for liml in head-organizer function, 3 74 nature 425 ( l995)(finding the gene liml to be the essential regulator of the organization of the vertebrate head). l 08. lori olwenstein, headless: lacking a single gene, mice are born without heads, discover, jan. 1, 1996, available at http://discovermagazine.com/1996/janlheadless658. 109. see jonathan slack, headless tadpoles & an informed public, 390 nature 111 (1997) (describing the british researcher who corrects misunderstandings of his own work which involves creation ofheadless tadpoles through the manipulation of genes). 110. roger highfield, patient's clones 'may grow transplant organs,' 1he daily telegraph, oct. 20, 1997, available at http://www.telegraph.eo.uk/htmlcontent.jhtml?html =/archive/1997/1 0/20/nclo20.html. 111. carol kahn, can we achieve immortality? the ethics of cloning and other life extension technologies, free inquiry, spring 1989, at 14-18. 112. david w. brock, cloning human beings: an assessment of the ethical issues pro and con, in nat'l bioetiiics advisory comm'n, 2 cloning human beings e4, e8 (1997). 113. philip elmer-dewitt, cloning: where do we draw the line?, time, nov. 8, 1993, at 65. 114. see d. alan shewmon et al., the use of anencephalic infants as organ sources, 261 j. am. med. ass'n. 1773, 1774-75 (1989) (estimating that donation :from naturally occurring anencephalic infants would produce only eleven usable organs per year in the united states due to the premature nature of most anencephalic births, low success rate of neonatal transplants, and logistical difficulties in the transplant network). 115. see transplant programs at mayo clinic, available at http://www.mayoclinic 36 indiana health law review [vol. 6:17 phalic donor organs should logically lead to better success from this particular source.116 additionally, some thinkers state that many of the donation consent problems inherent in today's transplant donor sources, such as truly "informed consent" and familial coercion, could be avoided in situations involving inten­ tionally created anencephalic organ donors.117 the presumption being, a head­ less organ donor would not have an interest in life necessitating consent to organ donation. further, the donor's parents would have presumably consented to its creation for transplant purposes.118 the argument is that once one accepts the ethical reasoning in support of allowing organ donation from anencephalic infants, it is a small leap along the same logical path to accept the ethical pro­ priety of allowing organ procurement from donor children intentionally created to be anencephalic.119 neoconservative pundit charles krauthammer dismays at the potential creation ofheadless human beings to be used as organ donors, as such an initia­ tive would reduce ''the human embryo to nothing more than a manufactured thing .... "120 such an action would thereby violate the kantian imperative to treat each person as an end in themselves, not a means to someone else's end.121 those seeking to temper this response point out that mankind does not yet have the ability to create headless human organ donors and that "[w ]hether the tech­ nologies that have stirred public fears will ever become a reality is hard to say. "122 by pairing human cloning and artificial reproduction technology, how­ ever, it is not difficult to imagine a research protocol for perfecting this tech­ nology. . yet, many americans who would not otherwise oppose scientific research into stem cells, cloning, and gene manipulation technology, would likely be put off by these endeavors, in addition to anencephalic organ dona­ tion, if the specter of intentionally creating anencephalic organ donors lurked in the shadows. those taking this position agree with krauthammer' s statement, made in .orgltransplant. ''mayo clinic doctors perform more than 1,100 transplants a year, making it the largest transplant program in the united states." id. 116. see richard j. howard, the challenging triangle: balancing outcomes, transplant numbers and costs, 7 am. j. 'transplantion 2443 (2007) (''transplant centers juggle at least three objectives important to success: transplant volume, outcomes and costs.") 117. laura j. hilmert, cloning human organs: potential sources and property implications, 771nd. l.j. 363, 369-70 (2002). 118. id. 119. shannon h. smith, ignorance is not bliss: why a ban on human cloning is unacceptable, 9 healmmatrix 311, 331 (1999) (noting that the utilitarian argument in favor of anencephalic organ transplantation may be even stronger in cases involving intentionally created anencephalic infants). 120. charles krauthammer, cloning debate is not another monkey trial, wash. post, may 10, 2002, available at http://www.townhall.com/columoists/charleskrauthammer/2002/ 05/l 0/clooing_ debate _is _not_ another_ monkey_ trial. 121. charles krauthammer, of headless mice ... and men, time, jan. 19, 1998, available at: http://www.time.com/time/magazine/article/0,9171,987687,00.html. 122. oliver morton & nigel w'tlliams, first dolly, now headless tadpoles, 218 science 798 (1997). see also robert pool, saviors, discover. may 1, 1998, available at http://discovermagazine.com/1998/may/saviors1442 (arguing that science will have less difficulty growing individual organs than growing headless organ donors in laboratories). 2009] paging king solomon 37 response to proposals for the allowance of embryonic cloning for research pur­ poses, but applicable in the present context, that "[t]his is not a slide down the slippery slope ... [t]his is downhill skiing."123 since the intentional creation of anencephalic organ donors transgresses the kantian injunction internalized by many americans, it is difficult to im­ agine such actions receiving legal protections at either the state or federal level any time soon. therefore, the fear of anencephalic infants being intentionally created to serve as organ sources stands as a potential roadblock to the effective use of naturally born anencephalic infants as organ donors, in addition to other potentially beneficial channels of scientific inquiry. any legal framework de­ signed to reap the benefits of anencephalic organ donation must therefore be carefully tailored so as to ensure that anencephalic organ donation rests on solid ground, safe from the slippery slope of anencephalic infants "on demand" for transplant purposes. a legal regime allowing for anencephalic organ donation should include provisions attacking the producers of intentionally created anen­ cephalic organ donors and those doctors unscrupulous enough to use organs from intentionally created anencephalic humans in transplant procedures. b. proposed legal rules to ensure the integrity of the anencephalic organ transplant process 1. criminalization of intentional creation of anencephalic human beings in order to ensure that scientists do not use emerging gene suppression technology to create an endless supply of artificially created anencephalic organ donors, lawmakers must impose criminal sanctions on anyone engaged in the intentional creation of anencephalic infants. such a measure would effectively eliminate, or at least reduce, the stream of artificially created anencephalic do­ nor organs at its source. current law and medical association guidelines do not directly address the intentional creation of anencephalic infants, although they have addressed similar bioethical issues, such as human cloning. as scholars have analogized the use of anencephalic organ donorsto the possibility of using body clones for transplant purposes, 124 statutory or organi­ zational bans on human cloning might influence the structure and rationale of a ban on the intentional creation of anencephalic organ donors. the medical community, acting through medical associations, has refused to go beyond ex­ pressing opposition to reproductive cloning and advising medical professionals to obey the laws of the nations in which they practice governing therapeutic 123. charles krauthammer, cloning debate is not another monkey trial, wash. post, may 10, 2002, available at http://www.townhall.com/colunists/charleskrauthammer/2002/ 05/1 0/cloning_ debate_ is_ not_ another_ monkey_ trial .. 124. see shannon h. smith, note, ignorance is not bliss: why a ban on human cloning is unacceptable, 9 health matrix 311, 329 (1999) (noting that, like anencephalic infants, body clones might lack the ability to be harmed due to the lack of capacity for consciousness). 38 indiana realm law review [vol. 6:17 cloning.125 some argue that forms of therapeutic cloning are morally indistin­ guishable from the deliberate creation of an anencephalic human being., 126 it seems unlikely that medical associations will lead the charge to condemn or punish the intentional creation of anencephalic infants for use as transplant do­ nors. legislatures must take charge in prohibiting the intentional creation of anencephalic organ donors, much as they have taken a leading role in condemn­ ing, regulating, and often criminalizing various forms of human cloning. 127 internationally, the issue of cloning creates huge controversy and concern, as indicated by the strange alliances and position shifts that occurred during the debate over the issue in the united nations ("un").128 the un eventually set­ tled on a non-binding call for a qualified ban on human cloning.129 it seems unlikely, however, that the un declaration on human cloning has put the is­ sue to rest given the stark differences in opinion expressed by different mem­ ber-nations during the un debate.130 while the legislative bodies in the united states have not addressed the intentional creation of anencephalic infants, they have taken positions on human cloning technology. several state legislatures have banned human cloning, often imposing criminal sanctions on those engaged in the practice.131 such regulations dem­ onstrate the willingness of american legislatures to address bioethical issues, 132 125. see american medical association, poucy e2.147: cloning to produce children (2003}, available at http://www.ama-assn.org/apps/pf_new/pf_online?f_n=result link&doc=policyfiles/hne/e-2.147 .htm&s_t=cloning&catg=ama!hne&catg=amaibn gnc&catg=ama/dir&&nth=l&&st_p=o&nth=3& (urging medical professionals not to pursue "cloning-to-produce-children at this time," which presumably would include artificially created anencephalic children); world medical association, the world medical association statement on genetics and medicine (2005}, available at http://www.wma. net/elpolicy/gl1.htm (opposing reproductive cloning. noting reproductive cloning is considered in many countries "to pose more of an ethical problem than therapeutic cloning" and urging medical professionals to obey codes of medical ethics in their countries regarding cloning). 126. ronald m. green, can we develop ethically universal stem cell lines, 8 na1ure reviews genetics 480, 481 (2007). 127. see ilffra notes 126-128 and accompanying text 128. see generally nigel m. des. cameron & anna v. henderson, brave new world at the genera/assembly: the united nations declaration on human cloning, 9 minn. j.l. sci. & tech. 145 (2008) (discussing debates between and position shifts of un membernations regarding un declaration on human cloning). 129. united nations general assembly, ljnmid nations declaration on human cloning (mar. 23, 2005) (calling on un member-states ''to prohibit all forms ofhuman cloning in as much as they are incompatible with human dignity and the protection of human life"). 130. see u.n. press release, general assembly adopts united nations declaration on human cloning by vote of 84-34-37 (aug. 3, 2005), available at, http://www.un.org/newsl press/docs/2005/gal 0333.doc.htm. 131. see, e.g., ark. code ann.§ 20-16-1002 (2003); cal. healm & safety code§ 24185 (2003);410 ill. comp. stat. ann. 110/40(west2008); ind. code§ 35-46-5-2 (2006); mich. comp.laws§ 750.430a(1999);nj. stat. ann. §2c:11a-1 (2004);n.d.cent.code§ 12.1-39-02 (2007); r.i. gen. laws§ 23-16.4-2 (1998); s.d. codjfied laws§ 34-14-27 (2004); va. code ann. § 32.1-162.22 (2001). 132. but see cmcago-kent col.u!ge of law ins'itiute for science, law, and technology, the laws of reproductive technology, available at http://www.kentlaw.edu/ is1at/reprotech.html (asserting that lawmakers have responded slowly to cloning and related 2009] paging king solomon 39 a trend which logically should extend as science makes the deliberate creation of anencephalic children clinically, if not politically, more feasible. additional­ ly, these anti-cloning laws already cover the possibility of creating human clones, including anencephalic clones, for the purpose of creating the perfectly matched organ donor.133 nevertheless, these anti-cloning regulations do not create national uniformity and do not cover the possibility that scientists might intentionally create non-clone anencephalic infants to serve as transplant organ reservoirs. therefore, new legislation is required. legislatures should take action to prohibit the intentional creation of anencephalic human beings. in particular, legislatures should not assume that parents will universally reject creating anencephalic organ donors should such technology become available. past incidents in which parents have used scien­ tific developments in assisted reproduction to create organ donors for previous­ ly conceived siblings134 vividly illustrates that any reliance on parents abstaining from creating another life as a means to save an existing child is sorely misplaced. desperate situations lead people, including parents and doc­ tors, 135 to do desperate things.136 thus, given the current state, the law must anticipate and address valid concerns regarding the deliberate creation of anen­ cephalic infants. to enable anencephalic organ donation in general to become legally and medically acceptable, legislative action is needed to properly circumscribe the particular practice of intentionally creating anencephalic children. it would be necessary to attack the sources of manufactured anencephalic donor organs in a couple of ways. specifically criminalizing the intentional creation of anence­ phalic human beings is an obvious first step. congress must pass such a statute in order to ensure uniformity in its application across the united states.137 this technologies). 133. see george w. mn.u!r, moral and etidcal impucations of human organ transplants 71· (1971) (explaining that risk of rejection declines when organs ftom an exact genetic match are transplanted into recipient). 134. see jacqueline brooks, sibling selection, webmd, june 26, 2001, available at http://www, webmd.com/news/2001 0626/sibling-selection (describing parents' decision to undergo invitro fertilization to create a baby boy who donated umbilical cord blood to his sister with a rare, incurable disease). see also curran v. bosze, 141 ill.2d 473 (1990) (holding that a father could not compel his minor twins to submit to bone marrow harvesting for the sake of their half-brother, who was the father's son by a different woman). 135. see rob stein, new practices in organ donation inspire debate, san francisco chronicle, march 19, 2007, at a-5 (noting that doctors already bend existing rules by beginning the organ harvesting process soon after a patient ceases to breath). 136. the case of the "pillow angel" caused quite a stir in both medical journals and the tabloid press. this case involved ashley. a severely mentally and physically disabled six-year­ old girl that intentionally had her growth halted by hormones, and had her uterus and breast buds removed by doctors at the request ofher parents. the parents stated on a blog, "ashley's smaller and lighter size makes it more possible to include her in the typical family life and activities that provide her with needed comfort, closeness, security and love: meal time, car trips, touch, snuggles, etc." see nancy gibbs, pillow angel ethics, time, jan. 22, 2007, available at http://www.time.comltime/0,8816,1574851,00.html. 137. see louise weinberg, fear and federalum, 23 omo n.u.l.rev.l295, 1317 (1997) (listing ''need for uniformity" among concerns that qualify as "national interests" often used to 40 indiana healtii law review [vol. 6:17 will also help avoid the creation of a medical tourism industry within america in which states that choose not to impose criminal penalties on the intentional creation of anencephalic organ donors would beckon transplant recipients from other states. 138 such a law would take the decision about whether to intention­ ally create an anencephalic infant out of the hands of doctors and desperate par­ ents, as while .. [p ]arents may be free to become martyrs themselves ... it does not follow that they are free, in identical circumstances, to make martyrs of their children,"139 including those children who might one day be intentionally programmed to develop as anencephalic through genetic manipulation. impos­ ing criminal sanctions on those intentionally creating anencephalic children will reduce the supply of such organs, but to ensure the integrity of a system legaliz­ ing anencephalic organ donation, legislatures must also address the possibility that doctors turning a blind eye to the source of donor organs might use organs from intentionally created anencephalic organ donors in transplants. 2. imposition of strict liability for anyone transplanting organs from in­ tentionally created anencephalic infants while criminalizing the intentional creation of anencephalic organ donors will presumably deter some would-be producers of anencephalic transplant or­ gans, that measure alone will not effectively control the black market almost certain to develop if the legalization of anencephalic organ donation coincides with the development of the technology to intentionally create anencephalic humans.140 we have already seen sophisticated black markets for the selling of kidneys from live donors arise, with some of the donors knowingly selling their organs, and others being coerced into doing so.141 a regime allowing for anen­ cephalic organ donation must provide strong ex ante disincentives for transplant physicians and clinics to use organs harvested from clinically manufactured anencephalic infants. ergo, congress must, in addition to criminalizing the intentional creation of anencephalic humans, impose strict criminal liability on any person transplanting organs from intentionally created anencephalic hujustify taking certain issues out of the bands of states). 138. congress could presumably pass such a law under its commerce clause powers, as evidenced by the supreme court's holding that prohibiting the intrastate possession or manufacture of an article of commerce, including items for which the only commercial market is illegal, is a rational means of regulating commerce in that product. gonzales v. raich, 545 u.s 1 (2004). see also wickard v. fillburn, 317 u.s. 111 (1941) (allowing congress to ban, under the commerce clause power, production of a small quantity of wheat for personal consumption and use). 139. strunk v. strunk, 445 s.w.2d 145, 150 (ky. 1969) (steinfeld, j., dissenting). 140. see michelle goodwin, altruism's limits: law, capacity, and organ commodification, 56 rutgers l. rev. 305 (2004) (detailing private organ sales and black markets in organs driven by patients seeking alternatives to an overloaded altruistic organ donation system). 141. see anuj chopra, organ-transplant black market thrives in india, s.f. chronicle, feb. 9, 2008 available at http:/lwww.sfgate.com/cgi-bin/article.cgi?f=/c/al 2008/02/09/mn23upqok.dtl. 2009] paging king solomon 41 mans. a strict liability crime "does not require a mens rea element", so that the mere commission of the criminal act itself, regardless of the motive of the per­ son committing the act, results in criminal punishment. 142 the imposition of strict liability on physicians and clinics that transplant organs from intentionally created anencephalic humans ensures that unscrupulous or careless physicians do not tum a blind eye to the source of their organs and keeps the difficult task of proving a physician • s knowledge or intent from undermining the integrity of the anencephalic donor system. 143 under such a statute, these medical profes­ sionals cannot avoid criminal penalties by claiming that they were unaware of the source of the donor organs used in their transplants. the proposed strict liability regime incentivizes medical professionals to ask questions about the source of their organs. these professionals, due to the threat of strict liability, will in effect support the law proposed abovecrimina­ lizing the intentional creation of anencephalic humansby refusing to partici­ pate in a market for donor organs from intentionally created anencephalic infants and verifying the sources of donor organs offered for use in their prac­ tices in order to protect their own professional interests. in effect, criminalizing the willful creation of anencephalic infants and imposing strict liability on phy­ sicians and clinics using transplant organs from this source will mutually rein­ force each other: physicians will respond to the threat of liability by investigating organ sources, thus reducing economic incentives to create anen­ cephalic transplant donors. the united network for organ sharing ("unos") would likely play a major role in this regime, administratively tracking whether banned organs are being used. this organization already "monitors every organ match to ensure adherence to unos policy, and works ... to develop equitable policies that maximize the limited supply of organs."144 therefore, unos already possesses the capabilities to track and audit organs obtained from anencephalic infants. for instance, upon detecting a statistical spike in the number of anencephalic organs used in transplant procedures conducted by a particular medical profes­ sional, a particular clinic, or in a particular region, unos could initiate an in­ vestigation. having legally represented a transplant center that was officially reviewed by unos for allegedly "upcoding" liver transplant patients, it is clear that unos possesses significant power to investigate and regulate transplant physicians and programs and can effectively shut down a transplant program by restricting access to organs procured through its national network. 145 however, 142. black's law dictionary (8th ed. 2004) (listing definition under "crime''). 143. see a.p. simester, appraising strict liability 25-33 (a.p. simester ed., oxford university press) (2005) (listing cost-effectiveness, administrative convenience, and difficulties of proof among rationales for imposing strict liability for criminal offenses). 144. united network for organ sharing, what we do, available at http://www.unos.org/whatwedo. 145. author fazal khan legally represented a large urban transplant center that was under unos investigation from 1995-1998. this investigation was taken very seriously by the 42 indiana health law review [vol. 6:17 being a non-profit, private organization, unos does not have the legal authori­ ty to impose criminal or civil sanctions. yet, the information gathered by unos can serve as a predicate to trigger state and federal criminal investiga­ tions. with the strict liability regime described in this subsection, transplant doctors and programs would have a strong incentive to investigate their organ providers, thus reinforcing the intended effect of criminal penalties for willfully creating anencephalic humans. congress should strongly consider this proposed legislation because the possible intentional creation of anencephalic organ donors, like human cloning. is "a matter far too important to be left solely in the hands of the scientific and medical communities!'146 this is because "any discovery that touches upon human creation is not simply a matter of scientific inquiry [but] a matter of mo­ rality and spirituality as well. "147 for medical culture and general society to accept a framework that allows anencephalic organ donation to occur, it is a desideratum that lawmakers address legitimate moral concerns regarding the intentional creation of anencephalic human beings for use as organ donors. legislatures can best accomplish this through the criminal law, as, in the view of the majority of people, the intentional creation of anencephalic humans would be a grave moral violation, and"[ c ]rimes are the sorts of serious wrongs that merit state punishment of the wrongdoer."148 by criminalizing the inten­ tional creation of anencephalic infants and imposing strict liability on physi­ cians and clinics using organs from intentionally created anencephalic infants in transplant procedures, congress would ensure that society could enjoy the ben­ efits of anencephalic organ donation without fear of the slippery slope. in par­ ticular, the allowance of the practice could lead to a brave new world in which scientists literally farm humans deliberately rendered anencephalic to serve as organ donors. vii. a possffile socioeconomic implication of anencephalic organ donation the allowance of organ harvesting from anencephalic infants, even if properly limited under a tight legal framework, could lead to unforeseen conse­ quences. one area of particular concern arises out of the disparity in ''the abili­ ty of members of different socioeconomic classes to benefit from such technology. "149 the possibility exists that, should anencephalic organ donation transplant program as they knew unos bad the power to severely limit their transplant . activities. the transplant program, however, was also aware that unos did not have the authority to impose criminal or civil sanctions. see press release, u.s. dep't justice, uic med. ctr. pays $2 million to u.s. and state of ill to settle liver transplant fraud suit (nov. 17, 2003) (available at http://www.usdoj.gov/usaofl1n/pr/chicagol2003/pr111703 _ ol.pdf). 146. james d. watson, moving toward the clonal man, ati..antic, may 1971, at 50. 147. bill clinton, remarks by president clinton on cloning (mar. 4, 1997) (transcript available at 1997 wl 571115). 148. grant lamond, what is a crime?, 27 oxford j. le.aal srun. 609, 631 (2007). 149. sandra anderson garcia, sociocultural and legal implications of creating and 2009] paging king solomon 43 be legally permitted, the practice could benefit children in society's higher so­ cioeconomic classes at the expense of those in lower socioeconomic classes. several factors render poor mothers more likely to give birth to children with anencephaly than their more economically advantaged counterparts.150 on the most obvious level, want of basic nutrition increases the incidence rates of birth defects of many varieties, 151 a fact that bears more heavily on the poor than the rich due to lack of resources. similarly, while folic acid supplementa­ tion has proven to be a successful technique in the fight to prevent anencepha­ ly/52 "[w]omen who were non-white, were aged 18-24 years, had less than a high school education, or had a household income of [less than] $25,000 were the least likely to report daily consumption of a supplement containing folic acid" in a recent study conducted by the center for disease control. 153 finally, environmental exposure to toxins, a plight which overwhelmingly affects the poor, can drastically increase the likelihood of neural tube defects such as anen­ cephaly.154 while poor women face an increased risk of anencephalic pregnancy, women from higher socioeconomic classes enjoy the benefits of increased pre­ valence of prenatal screening and ease of access to abortion, which, in tandem, render women from society's upper echelons much less likely than poor women to actually bring to term a fetus suffering from a genetic defect as serious as anencephaly. 155 one possible effect of this dynamic could be that, should anencephalic organ harvesting be permitted, the organs of anencephalic child­ ren of poor families willing to donate the organs of their children could be used to improve the lives of children of rich parents with access to high quality medsustaining life through biomedical technology, 17 j. legal med. 469, 473 (1996). 150. see birgitte m. blatter et al., review of neural tube dejects: risk factors in parental occupation and the environment, 102:2 envtl. healtii persp. 140, 141 (1994) (noting that across societies and racial groups, the prevalence of anencephaly increases as socioeconomic status decreases). see also yang et al., socioeconomic status in relation to selected birth dejects in a large mu/ticentered us case-control study, 167:2 am. j. epidemiol. 145, 150 (2008) (noting that an international trend also exists within the united states). 151. see generally susan l. carmichael et al., maternal food insecurity is associated with increased risk of certain birth defects, 137:9 j. of nutrition 2087 (noting that lack of access to food in sufficient quantities to meet basic needs increases occurrences ofbirth defects). 152. see de wals et al., supra note 9. 153. centers for disease control and prevention, use of supplements containing folic acid among women of childbearing age-united states, 2007, 57.11 morbid11y & mortali1y wkl y. rep. 5, 6 (jan. 11, 2008). 154. see, e.g., stemp-morlock, supra note 6, at a78 (linking pesticides to increased incidences of anencephaly among parents who work in agricultural fields); joshua m. kagan, note, workers' rights in the mexican maquiladora sector: collective bargaining, women's rights, and general human rights: law, norms, and practice, 15 j. 'f.ransnat'l l. & pol'y 153, 163 (2005) (observing high rates of anencephaly among industrial workers in factories along the border between the united states and mexico, presumably due to exposure to the toxin, pcb). 155. see sonia mateu suter, the routinization of prenatal testing, 28 am. j. l. & med. 233, 236 (2002) (noting that the rise in prenatal testing coincided with the recognition of a woman's right to an abortion, increasing the ability of women with access to medical care to control their reproductive lives). 44 indiana health law review [vol. 6:17 ical care capable of carrying out an infant transplant. this fear could cause some who would otherwise be willing to embrace anencephalic organ donation to instead shy away from the practice due to its possible class consequences. while concern over the class implications of a policy permitting anence­ phalic organ donation is legitimate, it should not bar the actual implementation of such a regime. to begin, until such a program is implemented, no one can know how these class concerns will play out in reality. additionally, the prob­ lem, should such concerns come to fruition, would arise not out of the policy permitting anencephalic organ donation, but would rather stem from the dispar­ ities in resources between the rich and the poor. the best solutions to these class concerns would attempt to provide poor mothers with greater access to prenatal care156 and nutrition,157 rather than attempting to ban anencephalic or­ gan donation altogether. viii. conclusion anencephaly results in swift death for those infants who suffer from it. even while their bodies live, these infants do not in any way experience the world or even their own existence. nevertheless, such children possess organs which could be used for transplantation into other children in need of them, ameliorating the effects of the fact that ''the demand for organs is far outstrip­ ping the supply.''158 from a utilitarian perspective, allowing donation of organs from anencephalic infants seems proper as it benefits the recipients of the or­ gans and the families of both the donor and recipient, while burdening the anencephalic donor herself to little or no degree. deontological concerns prove more troubling than utilitarian considera­ tions when dealing with anencephalic infant organ transplantation. while it would seem that such infants, when used as donors, are being treated as a means to an end, some unpersuasively counter with the utilitarian argument that allowing organ donations from anencephalic infants respects them "as human beings because they serve a highly worthwhile purpose. "159 a more persuasive response to these kantian concerns is, however, that anencephalic infants are born immediately into the state of death, due to their imminent physical death and their complete lack of consciousness or the potentiality for consciousness. 156. see carolyn jacobs cbachkin, what potent blood: non-invasive prenatal genetic diagnosis and the transformation of modern prenatal care, 33 am. j.l. & meo. 9, 38 (2007) (arguing that both public and private insurers should cover non-invasive prenatal testing, emerging technology capable of identifying fetal birth defects including anencephaly). 157. see g. maberly et al., trends in wheat flour-fortification with folic acid and iron­ worldwide, 2004 and 2007, http://www.cdc.gov/mmwr!preview/mmwrhtml/mm570la4.htm (last visited april4, 2008) (noting that as of2007, fifty four countries fortify their wheat flour with folic acid). 158. fred h. cate, human organ transplantation: the role oflaw,20 j. corp. l. 69, 70 (1995). 159. willke & andrusko, supra note 44, at 31. 2009] paging king solomon 45 such a view avoids the unfavorable consequences of abandoning the dead do­ nor rule altogether and eliminates the slippery slope risks inherent in declaring anencephalic infants to be non-people completely devoid of life due to their permanent lack of consciousness. this approach would legally define anence­ phalic infants as being born into death. this category, strictly limited to anen­ cephalic infants, would be added to the definitions of death adopted by the uniform determination ofdeath act, thereby making possible transplantation of the organs of anencephalic infants into newborns needing transplants without violation of the dead donor rule. unanswered questions remain as to some of the practical effects of a poli­ cy allowing anencephalic infants to serve as organ donors. one of these con­ cerns, the fear that scientists will intentionally create anencephalic organ donors, can be addressed legally, such as by the proposed laws criminalizing the intentional creation of anencephalic humans and imposing strict liability on transplant doctors using organs donated from intentionally created anencephalic infants. other issues cannot be addressed so simply. for instance, legitimate concerns exist that the allowance of anencephalic organ donation could benefit the children of the rich, who are more likely to have access to exceptional med­ ical care, at the expense of the poor, who remain more likely to give birth to an anencephalic child who might be used as a source of transplant organs.160 in addition, it remains questionable how great an impact the allowance of anence­ phalic organ transplantation will have on the dire predicaments of children in need of organs.161 these questions appear unanswerable in the absence of ac­ tual acceptance of a policy allowing the harvesting of anencephalic infants' or­ gans for transplantation. these unanswered questions should not delay the implementation of such a policy, as the use of anencephalic organs in trans­ plants is both morally justified and legally advisable. until those in positions of power deem such a policy permissible, infants born with defects that could be cured through a transplant will continue to die needlessly and the parents of anencephalic infants will continue to be denied a chance to transform their per­ sonal tragedy into an altruistic good. 160. see supra notes 1 04-l 08 and accompanying text 161. the number of anencephalic infants actually carried to term is limited, and the availability of abortion and genetic counseling will likely further decrease that number. see alexander morgan capron, anencephalic donors: separate the dead from the dying, hastings center rep., feb. 1987, at5 (observing that only 2,000 to 3,000 of such babies are born every year, not all of whom will be offered as organ donors by their parents); frank a. chervenak, et al., when is termination of pregnancy during the third trimester morally justifiable?, 310 new eng. j. med. 501,502 (1984) (noting that in cases of anencephaly, even third trimester abortion is largely considered ethically justifiable). see also doro'ihy c. wertz &johnc.fletcher,geneticsandenncsinglobalperspecnve373(2004)(490.4ofunited states genetic professionals would counsel for anencephaly in negative fashion, thereby making abortion of such infants more likely). policy, plain language, and legislative purpose: applying state medical malpractice caps on damages to federal emtala claims lauren n. grattenthaler· table of contents l; introduction .•....................... ; ...... ,;,;, ... : .... ;; ......... ; .....• ; •...• ,; ...... ;;: .•.. 86 ii. the statutory landscape: analytical framework and requirements of emt ala and state medical malpractice damage caps ......................................................... 90 a. interpreting emtala: the general statutory requirements and the courts' struggle to clarify the damages provision .............................................................. 90 b. . the medical liability crisis and tort reform: a general framework of state medical malpractice statutes and the effects of damage caps .................................. 92 iii. arguments for and against applying state medical malpractice damage caps to emt ala .................. 95 a. the minority view: unlimited damages through failing to apply state damage caps to emtala claims ......... 95 1. virginia: power v. arlington hospital ass 'n i .................... 96 2. florida: cooper v. gulf breeze hospital, inc . .................... 98 3. california: jackson v. east bay hospital.. .......................... 98 b. the majority view: limiting damages by applying state damage caps to emtala claims .................................... 99 1. the sixth circuit: smith v. botsford general hospital ........ 99 2. the fourth circuit: power v. arlington hospital ass 'n ii ................................................................ lol iv. promoting accessible, affordable, and high quality realm care: key policy reasons for applying state medical malpractice damage caps to emt ala claims .................................................................... 107 a. incorporating damage caps will prevent plaintif.fo from circumventing state damage caps by bringing their state malpractice claims in federal court * j.d. candidate, 2007, indiana university school of law, ind\anapolis, indiana; b.a., 2004, indiana university, bloomington, indiana. i would like to thank my family for their in­ valuable guidance, patience, and support, especially my mother, robyn, and my sisters, jaime and erin. 86 indiana health law review [vol. 4:85 under emtala .............................. ~ ....................................... 108 b. incorporating damage caps will prevent. forum shopping ...................................... ~ ................................ 110 c. incorporating damage caps furthers the purposes of emtala and state medical malpractice statutes ............................ ; .................................... 110 v. conclusion ................ · ................................................................... 112 i. introduction in response to concerns regarding the "dumping" of uninsured and indi­ gent patients by hospitals, congress enacted the emergency medical treatment and active labor act ("emtala"}1 as part of the consolidated omnibus budget reconciliation act ("cobra") of 19852•3 several studies conducted prior to the enactment ofemt ala estimated that emergency facilities dumped at least 250,000 patients each yeal and that eighty-seven percent of hospitals transferred patients for solely economic reasons.5 congress's primary purpose behind the enactment ofemtala was to prevent hospitals from refusing to treat indigent patients in emergency situations because of their inability to pay. in addition, emt ala was designed to curtail the transfer of indigent and unin­ sured patients by private hospitals to non-profit hospitals before life-threatening conditions had been stabilized.6 ultimately, the goal ofemtala was to en­ sure that every person had adequate access to emergency health care, especially the 'uninsured and indigent. 7 to further this goal of ready access to health care, many states have en­ acted medical malpractice statutes over the past few decades as part of a general 1 emergency medical treatment and active labor act (emtala), 42 u.s.c. § 1395dd (2000). 2 consolidated omnibus budget reconciliation act of 1985, pub. l. no. 99-272, § 9121, 100 stat. 82, 164-65 (1986). 3 leigh m. chiles, case note, summers v. baptist medical center arkadelphia: a "disparate" application ofemi'ala 's terms, 50 ark. l. rev. 559, 559 (1997). 4 wendy w. bera, comment, preventing "patient-dumping": the supreme court turns away the sixth circuit's interpretation of em!' ala, 36 hous. l. rev. 615,619 & n.19 (1999)(citingdavida. hyman, lies, damned lies, and narrative, 73 ind. l.j. 797,863 n.330 (1998) (arguing this estimate is misleading. however, because it is based on a skewed sample of large urban cities with a substantial number of indigent and uninsured individuals and an overly broad definition of"dumping")). 5 /d. at 619 & n.20 (citing robert l. schiff et al., transfers to a public hospital: [a prospective study of 467 patients], 314 new eng. j. med. 552, 556 (1986)). 6 chiles, supra note 3. 7 bryant v. adventist health sys., 289 f.3d 1162, 1169-70 (9th cir. 2002); see also bera, supra note 4, at 620. 2007] applying state damage caps to federal emt ala claims 87 tort reform movement sweeping across the country.8 these malpractice statutes often include some form of a damage cap, as well as medical review panel re­ quirements, a statute of limitations, and prescribed amounts of malpractice in­ surance coverage.9 while tort reform has been effective in many states in the context of medical malpractice, medical liability reform remains a primary fo­ cus of state medical associations' and the american medical association's ("ama") advocacy efforts to reduce medical liability premiums at the federal and state levels and ultimately, to improve quality and access to health care. 10 the initial call to state legislatures and congress for relief from the de­ clared malpractice crisis occurring in many states was prompted by dramatic increases in medical malpractice insurance premiums.11 these increases were a primary result of the high frequency of claims filed against health care profes8 see generally am. tort reformass'n, tort reform record (2005), available at http://www.atra.orglfiles.cgi/7990 _record _12-31-05.pdf(providing a state-by-state summary of tort reforms enacted since 1986). 9 see, e.g., ind. code§§ 34-18-1 to -18 (2004). in a recent unanimous opinion, ledbetter v. hunter, the indiana supreme court affirmed the constitutionality of the indiana medical malpractice act's statute of limitations for minors, reversing the indiana court of ap­ peals' opinion. ledbetterv. hunter, 842n.e.2d 810,815 (ind. 2006), rev'g810n.e.2d 1095, 1103 (ind. ct. app. 2004) (holding that the statute oflimitations for minors violated the privi­ leges and immunities clause of the indiana constitution). ledbetter restored the time period in which a minor may file a malpractice claim back to the original statute oflimitations, which is two years or until age eight if itijured before age six. /d. by upholding the original statute of limitations for minors, the court narrowed the window of time in which claims can be filed, thus preventing an additional flood of claims and a consequent adverse effect on medical malpractice insurance premiums. indiana supreme court upholds statute of limitations for mmors, isma reports (indiana state medical association, · indianapolis, indiana), mar. 6, 2006, at 1. therefore, the court's decision is consistent with the policies underlying medical malpractice statutes of ensuring a high· quality of and access to health care. in addition, this decision emphasizes that a plaintiff must have a strong showing to overcome the presumption of constitutionality applied to indiana's medical malpractice statute. /d. 10 the ama continues to lobby congress for malpractice liability reforms, such as a $250,000 cap on non-economic damages in medical liability cases. ama medical liability reform, http://www.ama-assn.orglamalpub/category/786l.html. 11 in 2002, physicians' malpractice insurance rates across the country increased ap­ proximately twenty percent on average. richard e. anderson, effective legal reform and the malpractice insurance crisis, 5 yale j. healmpol'y l. & ethics 341,344 & n.9 (2005) [hereinafter anderson, effective legal rtiform] (citing 2002 rate survey finds malpractice premiums are soaring . .. , med. liabiijtymonitor, oct. 2002, at i-n). however, states that have enacted effective malpractice legal reforms, such as california and indiana, have seen in­ surance rates grow by only a few percentage points per year during this same time period and enjoy some of the lowest rates in the country. id; see also richard e. anderson, defending the practice of medicine, 164 archives of internal med. 1173, 1174 (2004) [hereinafter anderson, defending the practice] (discussing the decrease in several states' insurance premium rates as a result of malpractice reforms). conversely, states without effective reforms. have experienced increases in excess of one hundred percent for physicians in high-risk medical specialties. anderson, effective legal reform, supra, at 345. 88 indiana health law review [vol. 4:85 sionals and the potentially unlimited, excessive verdicts being awarded to plain­ tiffs in malpractice suits. 12 to date, the ama has recognized twenty-one states that are currently in a state of medical malpractice liability crisis, an increase from twelve in 2002.13 because of the drastic premium rate increases, some physicians havebeen rendered virtually uninsurable at any price and have been forced to resort to state-run plans, 14 which are even more expensive than cover­ age in the insurance market, in order to continue practicing medicine.15 since the enactment ofemt ala and the emergence of medical malprac­ tice reform as a primary issue on legislative agendas, courts have struggled to draw a clear distinction between emt ala liability and traditional medical malpractice liability. 16 this is due, in part, to the similarities in the nature of the conduct often at issue in both emt ala and state medical malpractice claims. frequently, in an emt ala case, there is an underlying issue of possi­ ble medical negligence or substandard care; however, emt ala does not cre­ ate a cause of action on the basis of that type of conduct or theory.17 in addition, while courts generally agree that emtala does not create a federal cause of action for medical malpractice, 18 courts still disagree as to whether 12 see anderson, effective legal reform, supra note 11, at 344. 13 am. mel>. ass'n, america's medical liability crisis: a national view (2007), available at http://www.ama-assn.org/ama/noindex/category/1187l.html [hereinafter medical liability crisis map] (providing a map denoting "crisis," "caution," and "stable" states). 14 an example of such a plan is indiana's state insurance program, which provides that health care providers who are declined coverage by at least two insurers may apply for malprac­ tice liability insurance through the indiana residual malpractice insurance authority ("irmia"). ind. code § 34-18-17-6 (2004). 15 anderson, effective legal reform, supra note 11, at 345. 16 chiles, supra note 3, at 560. 17 see infra note 18 and accompanying text. 18 see, e.g., bryant v. adventist health sys., 289 f .3d 1162, 1170 (9th cir. 2002) (hold­ ing that a hospital could not be liable under emtala for its stairs failure to detect an emer­ gency medical condition because emt ala's purpose was to address the failure ofhospitals to provide emergency medical care to the uninsured and indigent and was not intended to be a federal malpractice statute); correa:v. hosp. san francisco, 69 f.3d 1184, 1192 (1st cir. 1995) ("emt ala does not create a cause of action for medical malpractice.''); eberhardt v. city of los angeles, 62 f .3d 1253, 1258 (9th cir. 1995); repp v. anadarko mun. hosp., 43 f.3d 519, 522(10thcir.l994); holcombv. monahan,30f.3d 116,117 (llthcir.l994). thus, although a failure to follow regular screening procedures may violate emtala, a fiwlty screening, "as opposed to disparate screening or refusing to screen at all," does not. correa, 69 f .3d at 119293. furthermore, courts have maintained that a claim alleging misdiagnosis or inadequate treatment is a matter of state malpractice law. see vickers v. nash gen. hosp., inc., 78 f .3d 139, 142-43 (4th cir. 1996); summers v. baptist med. ctr. arkadelphia, 91 f.3d 1132, 1137 (8th cir. 1996); williams v. birk:eness, 34 f.3d 695, 697 (8th cir. 1994) (holding that emtala claims do not rest upon proof that a hospital was negligent or that the hospital failed to make a correct diagnosis or provide adequate treatment); brooks v. maryland gen. hosp., inc., 996 f .2d 708, 710 (4th cir. 1993) ("the act was not designed to provide a federal remedy for misdiagnosis or general malpractice."); baber v. hosp. corp. of am., 977 f.2d 872, 880 (4th 2007] applying state damage caps to federal emtala claims 89 federal emt ala claims are subject to caps on damages provided for in state medical malpractice statutes.19 this disagreement stems from the issue of what constitutes "damages available for personal injwy'' provided for in emtala's damages provision20, as well as the varying ways in which states define "mal­ practice."21 the need for clarification on this issue has been heightened by the flood ofemt ala claims following its enactment, especially considering the potential policy implications and adverse effects that judicial decisions concern­ ing those claims could have on health care in the united states.22 this note asserts the majority position that, although emtala is not technically a federal medical malpractice statute, damages applicable to state medical malpractice claims should likewise apply to emt ala claims. part ii of this note will focus on the general background ofemtala and state medical malpractice statutes, outline the main provisions of emt ala, and discuss the structure and mechanics of typical state medical malpractice statutes, specifically, the damage cap provisions. part iii will examine the ar­ guments for and against the application of state medical malpractice damage caps to emt ala claims. in doing so, this section will look at several court decisions in various jurisdictions that have analyzed the language and applica­ tion ofemtala's damages provision. specifically, courts have focused on the issue of whether emt ala incorporates state medical malpractice caps on damages, thus subjecting emtala claim recoveries to those limits. part iv will discuss and analyze the key policy reasons for incorporating state damage caps into emt ala. part v will conclude with a brief summary of the reasons for applying damage caps to emt ala while focusing on the underlying objec­ tives of both emt ala and state medical malpractice statutes. cir. 1992) ("emtala is no substitute for state law medical malpractice actions."). rather, emtala was intended to create a wholly new cause of action, separate and distinct from traditional state medical malpractice claims. see gatewood v. washington health­ care corp., 933 f.2d 1037, 1041 (d.c. cir. 1991) (holdingthattheplaintiffcouldnotbring a malpractice claim under emtala because that would result in a federalization of malpractice claims, which courts have sought to avoid, and would thereby permit virtually any claim of medical malpractice to be brought as an emt ala action; emtala "is not intended to dupli­ cate preexisting legal protections ... . j; see also vickers, 78 f.3d at 141. in addition, emtala "does not set a national emergency health care standard." summers, 91 f.3dat 1137. 19 see chiles, supra note 3, at 560; for an interesting discussion ofemtala as a fed­ eral malpractice statute, see demetrios g. metropoulos, note, son of cobra: the evolution of a federal malpractice law, 45 stan. l. rev. 263 (1992). 20 42 u.s.c § 1395dd(d)(2)(a) (2000). 21 see discussion infra parts ill.a1, b.l-.2. 22 chiles, supra note 3, at 560. 90 indiana health law review [vol. 4:85 ii. the statutory landscape: analytical framework and requirements of emtala and state medical malpractice damage caps a. interpreting em/' ala: the general statutory requirements and the courts' struggle to clarify the damages provision under common law, a physician does not owe a duty to provide medical treatment. 23 in addition, hospitals do not owe a duty of care directly to patients because a hospital is not considered to be practicing medicine.24 without emt ala, hospitals would be able to refuse treatment to anyone, even those patients w.ith life-:-threatening conditions.25 thus, assuming that most health care providers would not voluntarily treat patients if they knew in advance they would not be compensated, the enactment of emt ala was necessary to en­ sure adequate access to emergency health care. 26 although emt ala was enacted in response to concerns that hospitals were dumping patients because of their inability to pay, it applies to all patients who seek emergency treatment, regardless of their ability to pay or insurance status, and is not explicitly limited to indigent patients.27 emt ala requires all 23 e.g., hurley v. eddingfield, 59 n.e. 1058, 1058 (ind. 1901) (holding licensed physi­ cian not required to respond to a call), cited in bera, supra note 4, at 621; oliver v. brock. 342 so. 2d 1, 3 (ala. 1976) (stating physician is under no obligation to accept professional employment); findlay v. bd. of supervisors of mohave county, 230 p.2d 526, 531 (ariz. 1951}; childers v. frye, 158 n.e. 744, 746 (n.c. 1931). 24 e.g., schloendorffv. soc'yofnewyorkhosp., 105n.e. 92,93 (n.y.1914),citedin bera, supra note 4, at 623 n.36 (explaining that the hospital is not liable for the negligent ac­ tions of physicians in the treatment of patients because physicians act as independent contractors), superseded by statute, n.y. pub. healmlaw § 2805-d (mckinney2002 & supp. 2007) (effective july 1, 1975); bera, supra note 4, at 623. 25 bera, supra note 4, at 623. 26 id. at 621-22. emtala has been criticized, however, as contradictory to state tort reform enactments because it gives plaintiffs and their attorneys yet another avenue through which to sue. it also enables plaintiffs to circumvent state damage caps and thus recover greater monetary awards by framing traditional medical malpractice claims as emtala claims. see discussion infra part iv .a. in addition to damage caps, plaintiffs may also be able to avoid other state statutory requirements applicable in medical malpractice cases, such as mandatory arbitration. id at 636-37; see generally discussion infra part iv. in addition, emtala has been referred to as an •'unfunded mandate that requires hospitals and physicians to provide emergency care without establishing a way to pay for that care." julia ai, note, does em!' ala apply to inpatients located anywhere in a hospital?, 32 rutgers l.j. 549, 551 (2001). 27 see collins v. depaul hosp., 963 f .2d 303, 308 (1oth cir. 1992); gatewood v. wash­ ington healthcare corp., 933 f.2d 1037, 1040 (d.c. cir. 1991) (concluding that the plain language of emtala under a strict interpretation of the statute extends protection to all individuals and not just the indigent); thornton v. sw. detroit hosp., 895 f .2d 1131, 1134 (6th cir. 1990). furthermore, the phrase "[i]f any individual ... comes to a hospital ... ," 42 u.s.c. § 1395dd(bx1) (2000), allows emtala to be applied in a wide variety of situations. bera, supra note 4, at 623. 2007] applying state damage caps to federal emtala claims 91 hospitals participating in medicare and medicaid to provide an "appropriate medical screening examination within the capability of the hospital's emer­ gency department" to every person who comes to the emergency room andre­ quests treatment, in order to determine whether or not an emergency medical condition exists. 28 if an emergency condition exists, the hospital has a duty to treat and stabilize the condition or transfer the patient if the benefits of transfer outweigh the risks ofharm to the patient 29 although hospitals are required to stabilize emergency patients, emt ala does not require them to perform the impossible. 30 if a hospital does not have the facilities necessary to fully stabi­ lize a patient, and the patient must be transferred to another hospital to receive the necessary care, the first hospital can transfer the patient to the more sophis­ ticated hospital without violating emtala.31 the transferring hospital must do all it can to stabilize the patient's condition, but it need not do what it can­ not. 32 thus, a hospital may violate emt ala by either failing to provide an appropriate medical screening, or if an emergency condition is found to be pre­ sent in the initial screening, failing to stabilize or transfer the patient appropri­ ately.33 an emt ala screening obligation is triggered in one of two ways: 1) when an individual presents at a hospital emergency department and requests examination or treatment for a medical condition,34 or 2) when the individual presents somewhere else on hospital property (but not recognized as part of the emergency department) and requests examination or treatment for an emer­ gency medical condition. 35 a hospital would also incur an emtala screening obligation if the individual was unable to make a verbal request but displayed symptoms that indicated a clear possibility of an emergency medical condi­ tion. 36 under such a screening obligation, it is not required that an emergency medical condition actually be found to exist upon subsequent examination. rather, in the absence of an actual screening request, a request is deemed to exist if a prudent layperson observer would believe, based on the individual's 28 § 1395dd(a); chiles, supra note 3, at 559. 29 § 1395dd(b x 1 ); see chiles, supra note 3, at 566-67. 30 mark a. hall, mary anne bobinski & david orentlicher, heal til care law and etiiics 124 (aspen 6th ed 2003 & supp. 2006) (supplement available at http://indylaw. indiana.edu/instructors/orentlicherlhealthlw/chap2al.html). 31 id. 32 id (citingcherukuri v. shalala, 175 f.3d446(6thcir.1999)(dismissingemtala claims against a physician at a small rural hospital who transferred two patients who needed a particular surgery to stop internal bleeding from an automobile accident)). 33 amy j. mckitrick, note, the effect of state medical malpractice caps on damages awarded under the emergency medical treatment and active labor act, 42 clev. st. l. rev. 171, 176(1994). 34 42 c.f.r. § 489.24(bx1) (2006). 35 id. § 489.24(bx2). 36 !d. § 489 .24(b ). 92 indiana health law review [vol. 4:85 symptoms, that the individual needed emergency care.37 a hospital's obliga­ tions cease once the patient has been adnlitted to the hospital as an inpatient. 38 hospitals that fail to provide an appropriate medical screening or to stabi­ lize an emergency condition are subject to heavy civil penalties under emt ala. 39 emt ala creates a private cause of action for damages against such hospitals when an individual suffers harm as a direct result of a hospital's emtala violation. this provision, at issue in this note, states: any individual who suffers personal harm as a direct re­ sult of a participating hospital's violation of a require­ ment of this section may, in a civil action against the participating hospital, obtain those damages available for personal injury under the law of the state in which the hospital is located, and such equitable relief as is appro. priate.40 a large portion of the courts' emt ala decisions have focused on the in­ terpretation and application of this provision. the disagreement among courts concerning the applicability of state dam­ age caps to emt ala claims is primarily a result of the ambiguity of the aforementioned damages provision, and in particular, the language permitting an individual to "obtain those damages available for personal injury under the law of the state .... " when an emtala claim seems to implicate medical malpractice issues, the confusion surrounding the applicability of state medical malpractice damage caps under the emt ala damages provision becomes a primary concern for physicians, potential plaintiffs, attorneys, and courts. spe­ cifically, courts must determine whether ''personal injury'' damages include those available for medical malpractice claims. courts faced with this should consider multiple factors including, but not limited to, the following: the con­ gressional purpose, legislative history, and relevant policies underlying both emt ala and medical malpractice statutes and the potential implications the court's decision will have for professional liability and the general cost of and access to health care. b. the medical liability crisis and tort reform: a general framework of state medical malpractice statutes and the effects of damage caps at the local level, states have statutorily imposed medical malpractice damage caps as an element of general tort and medical liability reform in re37 id 38 id §§ 489.24(axii), (dx2). 39 42 u.s.c. § 1395dd(d){l)-(2) (2000); chiles, supra note 3, at 559, 567. 40 § 1395dd( dx2)(a). 2007] applying state damage caps to federal emt ala claims 93 sponse to the medical malpractice crisis occurring across many states as a result of''the nation's out-of-control legal system ... .'.41 the current system is forc­ ing physicians to retire early, relocate, or refrain from performing high-risk medical procedures.42 everyday, there are more than 120,000 malpractice ac­ tions pending against physicians in the united states, and one-sixth of ameri­ can physicians report a claim against them each year.43 these numbers are even higher for high-risk specialties.44 the amount of malpractice verdicts in states with uncapped medical liability is even more astounding.45 for example, texas reported a $606 million verdict in 2005,46 pennsylvania had multiple verdicts of more than fifty million dollars each, and together, new york and pennsylvania paid nearly one billion dollars in malpractice indemnity in 2000.47 in order to pay such unlimited judgments, insurers must charge unlimited pre­ miums.48 some states have declared themselves to be amidst a medical liability cri­ sis as a result of the staggering increase in the cost of malpractice insurance and the consequent decrease in access to critical medical services.49 soaring medi­ cal malpractice insurance rates and the increased exposure to liability in the united states has resulted, at least in part, from the escalating costs of defend­ ing malpractice claims, which are inevitably linked to the increase in both the volume of such litigation and the size of plaintiffs' awards. 5° thus, in an effort to combat the rising costs of malpractice insurance premiums resulting from excessive awards to plaintiffs in malpractice litigation, state legislatures have included various forms of damage cap provisions in their state medical mal­ practice statutes. 51 41 medical liability crisis map, supra note 13. 42 /d. 43 anderson, defending the practice, supra note 11. 44 some high-risk specialties include neurosurgery, orthopedics, obstetrics, trauma surgery, emergency medicine, and plastic surgery. id as one example of the heightened crisis within high-risk specialties, one in seven obstetricians no longer delivers babies because of the rising cost of liability insurance and the fear of being sued. a.m. med. ass'n, america's medical liabiuiy crisis, medical liability reform fast facts (2006), http://www.ama­ assn.org/amal/pub/upload/mm/399/mlr_fastfit.cts.pdf. 45 anderson, defending the practice, supra note 11. 46 a jury found a cancer clinic was responsible for the death of an eighty-two-year-old man who died after receiving an overdose of chemotherapy drugs. featherston v. richardson hosp., no. 03-08488 (dallas county dist. ct., tex. mar. 4, 2005). this medical malpractice suit was filed prior to the 2003 enactment oftexas' $250,000 cap on non-economic damages. see natalie white, overdose of chemotherapy meds leads to $606 million verdict, lawyers usa, 2006 special feature, available at http://www.lawyersweeklyusa.com/usa/2topten 2005.cfin. , 47 anderson, defending the practice, supra note 11. 48 /d. at 1177. 49 /d. at 1173 (including specialties, such as obstetrics and trauma care). 50 anderson, effective legal reform, supra note 11, at 344. 51 california passed the medical injury compensation reform act ofl975 ("micra'~ 94 indiana health law review [vol. 4:85 medical malpractice damage caps limit the damages recoverable by an in­ jured plaintiff and those whose claims against a health care provider derive from the patient's injury. 52 while all fifty states have some form of medical malpractice liability statute, the type of damage cap provided varies from state to state. 53 states with damage caps may have either a mandatory54 or a discre­ tionary cap restriction. 55 some specific forms of damage restrictions include limits on non-economic damages,56 limits on either general or punitive dam­ ages,57 and limits on all damages except for medical care and related ex­ penses.58 and since has seen a premium rate decrease of forty percent. anderson, defending the practice, supra note 11. the four major components of micra include: i) a $250,000 cap on non­ economic damages; 2) defendants may introduce into evidence additional sources of compensa­ tion for injury that have already been paid (collateral source reform); 3) periodic payments of damage awards; and 4) limits on contingency fees using a sliding scale. anderson, effective legal reform, supra note 11, at 350. indiana also passed comprehensive reforms around the same time as california and now enjoys some of the lowest malpractice insurance rates in the country. anderson, defending the practice, supra note 11. in contrast, oregon has seen dra­ matic rate increases since its supreme court invalidated a twelve-year-old $500,000 cap on non­ economic damages in 1999. id.; see lakin v. senco prod., 987 p.2d 463,474 (or. 1999). plaintiff's attorneys and other groups that believe current levels of malpractice litiga­ tion are not excessive assert that today's high premiums are not caused by increasing claims costs but are instead a result of insurance company mismanagement and poor investments. anderson, defending the practice, supra note 11, at 117 5. 52 carol a. crocca, annotation, validity, construction, and application of state statutory provisions limiting amount ofrecovery in medical malpractice claims, 26 a.l.r. 5th 245 (1995). 53 mark d. clore, medical malpractice death actions: understanding caps, stowers, and credits, 41 s. tex. l. rev. 467, 471, 509 (2000)(surnmarizing state damage cap provisions as ofl998). 54 see, e.g., cal. civ. code § 3333.2 (west 1997 & supp. 2007) (limiting non­ economic damages to $250,000); ind. code§ 34-18-14-3 (2004) (limiting damages to a total of $1.25 million and $250,000 on damages recoverable from each health care provider; excess paid through patient compensation fund). 55 see clore, supra note 53, at 471. 56 see, e.g., cal. civ. code § 3333.2 (west 1997 & supp. 2007); mo. ann. stat. § 538.210 (west 2000 & supp. 2006) (placing a $350,000 cap on non-economic damages per plaintiff); wis. stat. ann.§ 893.55 (west 2006) (placing a $750,000 cap per occurrence on or after apr. 6, 2006, on non-economic damages). 57 see, e.g., fla. stat. ann.§§ 766.118(2)(a), (4)(a), 768.73(1)(a) (west2005)(limit­ ing recovery to $500,000 per claimant on non-economic damages and $150,000 per claimantfor practitioners providing emergency services; limiting punitive damages to three times the amount of compensatory damages awarded or $500,000, whichever is greater). 58 clore, supra note 53, at 471; see, e.g., va. code ann. §§ 8.01-38.1, 8.01-581.15 (2000 & supp. 2006) (limiting all damages except for medical care and related expenses, includ­ ing a $350,000 cap on punitive damages and a total limit of$1.5 million in 1999 with increases of $50,000 each year until 2007 and then an increase of $75,000 in 2007 and 2008). according to the ama' s advocacy resource center, the following nineteen states do not have a cap on non-economic damages (as offebruary 2007): alabama, arizona, arkansas, connecticut, delaware, iowa, kentucky, minnesota, new hampshire, new jersey, new york, north carolina, oregon, pennsylvania, rhode island, tennessee, vermont, washington, and 2007] applying state damage caps to federal emt ala claims 95 clearly, such damage caps would apply to claims of malpractice, or medi­ cal negligence, but since the enactment ofemt ala, plaintiffs have often filed what are essentially medical malpractice-based suits under the guise of an emt ala claim, possibly in order to circumvent the application of state dam­ age caps, thus affording them an opportunity to obtain a larger award. as a result, courts have faced the challenge of interpreting emt ala's language to determine whether damages for personal injury include those available for medical malpractice claims, and thus whether state damage caps apply to emtala claims. ultimately, courts must consider, when determining the ap­ plicability of state damage caps to emt ala claims, whether they want to open the door for potential plaintiffs to circumvent state damage caps by framing a malpractice-based claim as a federal emtala claim. til arguments for and against applying state medical malpractice damage caps to emtala a. the minority view: unlimited damages through failing to apply state damage caps to emt ala claims while the majority of courts have interpreted emtala to incorporate state damage caps, a few courts have declined to apply medical malpractice damage caps to emtala claims. 59 typically, when determining whether a particular state damage cap applies to an emt ala claim, federal courts look at the underlying conduct being challenged and the legal theory on which it is be­ ing challenged in order to ascertain whether, if brought under state law, it would constitute a cause of action subject to the cap.60 while the district court's decision in power was ultimately reversed by the fourth circuit,61 its reasoning highlights the primary arguments against applying a state damage cap to an emtala claim. it is helpful to distinguish the analyses of the district court and the fourth circuit, in addition to other courts, in order to better un­ derstand the varying statutory constructions ofemtala that have been used by courts to determine whether to incorporate state medical malpractice damage caps. wyoming. advocacy res. ctr., am. med. ass'n, caps on damages (2007). while louisi­ ana's damage cap was ruled unconstitutional by the louisiana court of appeal in arrington v. er physicians group, 04-1235 (la. app. 3 cir. 9/27/06); 940 so. 2d 777, 784, this decision was recently vacated and set aside by the supreme court of louisiana in arrington v. galen­ med, inc., 06-2968 (la. 2/2/07) (holding that constitutional challenges to statutes must be raised and specially pleaded in the trial court). 59 e.g., .power v. arlington hosp. ass'n, 800 f. supp. 1384, 1392 (e.d. va. 1992) [hereinafter .power ij, rev'd, 42 f.3d 851 (4th cir. 1994). 60 barris v. county of los angeles, 972 p.2d 966, 974 (cal. 1999); see smith v. bots­ ford gen. hosp., 419 f.3d 513, 518 (6th cir. 2005), cert. denied, 126 s. ct. 1912 (2006) (mem.); powerv. arlington hosp. ass'n, 42 f.3d 851,862 (4th cir. 1994) [hereinafter power ii]. 61 see discussion infra part iii.b.2. 96 indiana health law review [vol. 4:85 i. virginia: power v. arlington hospital ass 'n i in power i, the plaintiff filed suit in federal district court alleging that the transferring hospital failed to appropriately screen her for an emergency condi­ tion. stabilize her medical condition, and provide her medical records to the receiving hospital in the transfer as required under emt ala. 62 she was awarded five million dollars in damages, despite the one million dollar statutory cap virginia placed on medical malpractice claims.63 in its analysis, the district court interpreted the language "damages avail­ able" in § 1395dd( d)(2)(a) ofemt ala to "plainly mean[] ... those elements of damage for which recovery is permitted under state law . ..64 the court also stated that the "language of 1395dd ( dx[2])(a) is refreshingly clear and simple: the damages available for 'patient dumping' actions are the state's personal in­ jury damages. "65 the court determined that there were no limits on personal injury claims in virginia, and recovery under emt ala was not limited to "damages available for personal injury except as may be limited in certain states by medical malpractice statutes."66 the court interpreted emtala very narrowly to find that damages for personal injury included only personal injury 62 power i, supra note 59, at 1386-87. the plaintiff presented to the emergency room at a virginia hospital, complaining of chills and pain in her hip. jd. at 1386. she was examined by two physicians who took her vital signs, conducted a hip x-ray, and performed a urinalysis. /d. although the physicians' diagnosis was uncertain, they diagnosed her with a possible neuro­ logical or musculoskeletal condition. ld the plaintiff was discharged two hours later with a prescription for pain medication and was told to return ifher condition worsened. !d. the next day, the plaintiff was again admitted to the hospital. ld. she stayed in the hospital for four months during which both ofher legs were amputated and she became blind in one eye. jd she was finally transferred by defendant hospital to a hospital in great britain. /d. 63 power ll, supra note 60, at 854. at the time of power i, virginia's medical malprac­ tice cap provi4ed that "[i]n any verdict returned against a health care provider in an action for malpractice ... which is tried by a jury ... the total amount recoverable for any injury to, or death o~ a patient shallnotexceedonemilliondollars." va. code ann.§ 8.01-581.15 (1992), cited in power i, supra note 59, at 1387. "malpractice" was defined in the statute as "any tort based on health care or professional services rendered, or which should have been rendered, by a health care provider, to a patient." va. code ann.§ 8.01-581.1 (1992), cited in power ll, supra note 60, at 861. under the statute, "health care" was defined as "any act, or treatment perfunned or furnished, or which should have been performed or furnished, by any health care provider for, to, or on behalf of a patient during the patient's medical diagnosis, care, treatment or confinement." ld, cited in power ii, supra note 60, at 861. 64 power i, supra note 59, at 1388, cited in power ll, supra note 60. 65 jd 66 /d. at 1389. 2007] applying state damage caps to federal emt ala claims 97 and not malpractice damages.67 by inference, however, personal injury could include negligence, including malpractice, damages.68 nonetheless, the district court went on to distinguish the term "personal injury," as used in § l395dd(d)(2)(a), from the term "malpractice," and then pointed out that there is a "conspicuous absence from the emt ala 'patient dumping' provision of any limiting language.'.69 the district court relied on these points to bolster its conclusion that § 1395dd(d)(2)(a) limited ms. power's damages to only the elements allowed under virginia law for personal injury, 70 and that if congress had intended to incorporate malpractice damage caps into emt ala, it "would surely have chosen more precise language.'m the court further reasoned that emt ala was neither a tort nor a negli­ gence action; rather, it was a ''sui generis federal statutory action."72 in addi­ tion, applying a state damage cap would conflict with congress's objectives behind emtala, which were to deter patient dumping and to compensate those who were illegally dumped.73 furthermore, these goals would be hin­ dered by low state recovery caps.74 67 see id.; heather k. bardot, cobra strikes at v"uginia 's cap on malpractice actions: an analysis of power v. arlington hospital [,ass'n], 2 geo. mason ind. l. rev. 249, 256 (1993). 68 black's law dictionary defines "personal injury'' as "(i]n a negligence action, any harm caused to a person." black's law dicnonary 802 (8th ed. 2004); see bardot, supra note 67, at 257. 69 power i, supra note 59, at 1389. 70 according to virginia's model jwy instructions, the elements that are considered when determining damages for personal injwy are: 1) any bodily injuries he sustained and their effect on his health according to their degree and probable duration; 2) any physical pain [and mental anguish] he suffered in the past [and any that he may be reasonably expected to suffer in the future]; 3) any disfigurement or deformity and any associated humiliation of embarrassment; 4) any inconvenience caused in the past [and any that probably will be caused in the future]; 5) any medical expenses incurred in the past [and any that may be reasonably expected to occur in the future]; 6) any earnings he lost because he was unable to work ... ; 7) any loss of earnings and decrease in earning capacity, or either, that he may reasonably be expected to sustain in the future; 8) any property damage he sustained. id at 1388 (brackets in original)( citing virginia's model jwy instructions, inst. no. 9.000 (1988)). 71 id at 1390. 72 id at 1391. 73 id at 1392. 74 id. 98 indiana health law review [vol. 4:85 2. florida: cooper v. gulf breeze hospital, inc. in cooper v. gulf breeze hospital, inc., 75 the court also held that the state damage cap 76 did not apply to the plaintiff's emt ala claim. 77 it reasoned that emt ala creates a cause of action based on strict liability, distinct from mal­ practice causes of action, which are based on negligence. 78 the court also dis­ cussed the indiana decision of reid v. indianapolis osteopathic medical hospita/,19 which held that emtala does not incorporate state procedural requirements in medical malpractice statutes but does incorporate state substan­ tive damage caps.80 the cooper court noted, however, that florida's statute was schematically different from indiana's statute in reid and virginia's statute in power i81 because florida's law "conditions damage caps on the pre-suit procedures followed by the parties. "82 thus, it was unclear to the court whether reid would support incorporating damage caps when this would require incor­ porating procedural requirements as well. 83 ultimately, the court found that the plaintiff's emtala claim was not limited by florida's medical malpractice statute.84 3. california: jackson v. east bay hospital considering the purpose and intent ofemt ala and the relevant legisla­ tive history, the court in jackson v. east bay hospitaf5 also refused to apply 75 cooper v. gulf breeze hosp. inc., 839 f. supp. 1538, 1540 (n.d. fla. 1993) (involving a patient who went to the emergency room after suffering a stroke, was discharged with instructions to see his heart doctor, and later suffered from paralysis and speech problems; patient filed an emt ala suit against the hospital for discharging him without first stabilizing his condition). 76 florida's medical malpractice statute provided that either a potential plaintiff or de­ fendant may offer to arbitrate the amount of damages in a malpractice action rather than have the issue go to trial. jd. at 1542 (citing fla. stat. ann. § 766.206 (west 1993)). if the potential plaintiff refuses to arbitrate, then his or her recovery for non-economic damages is capped at $350,000 per incident of malpractice. ld. 77 ld. at 1543 (stating that emt ala does not incorporate florida's medical malpractice law and thus does not incorporate damage limits on malpractice actions). 78 /d. at 1542; see also williams v. birkeness, 34 f.3d 695,697 (8th cir. 1994). while most often, medical malpractice claims are based on theories of negligence, plaintiffs have based medical malpractice claims on strict liabi1itytheories as well. see hoven v. kelble, 256 n.w.2d 3 79 (wis. 1977) (medical malpractice claim based on a theory of strict liability, although court ultimately refused to apply that theory). 79 reid v. indianapolis osteopathic med. hosp., 709 f. supp. 853 (s.d. ind. 1989). 80 jd. at 855-56, cited in cooper, 839 f. supp. at 1543. 81 power i, supra note 59. 82 cooper, 839 f. supp. at 1543. 83 ld. 84 id. 85 jackson v. e. bay hosp., 980 f. supp. 1341, 1344, 1346 (n.d. cal. 1997) (plaintiff 2007] applying state damage caps to federal emt ala claims 99 the state damage cap on medical malpractice suits to emt ala claims because, according to the court, emt ala incorporated state caps on personal injury claims but not those caps that are specific to medical malpractice claims. 86 in its reasoning, the court stated that "emt ala clearly incorporates state law in the determination of damages," but the extent or scope of that incorporation is the ultimate issue. p>r the court concluded that because its medical malpractice statute, micra, 88 does not extend to all tort claims but rather only to those ac­ tions "based on professional negligence," the damage cap did not apply to an emtala cause of action. 89 without a showing of negligence, the court re­ fused to apply the damage cap to the emt ala claim.90 although this case law offers seemingly persuasive reasons to exclude damage caps from emt ala claims, the majority of courts have held otherwise based on more compelling reasons that focus on the plain language ofemt ala, legislative purpose, and policy. b. the majority view: limiting damages by applying state damage caps to emt ala claims 1. the sixth circuit: smith v. botsford general hospital recently, in an issue of first impression, the united states court of ap· peals for the sixth circuit joined the majority of courts91 and held that michi­ gan's cap on malpractice damages applies to federal emtala claims, thus limiting the amount of damages a plaintiff can recover for his or her emt ala claim.92 in smith v. botsford general hospital, the plaintiff alleged that the defendant hospital violated emtala when it failed to stabilize the deceased's condition before transporting him.93 on appeal, the hospital contended that the non-economic damages awarded by the jury ($5 million) following trial in the asserted that several doctors and nurses witnessed patient go into cardiac arrest and still trans­ ferred him to another hospital instead of providing treatment in violation ofemtala), aff'd on other grounds, 246 f.3d 1248, 1262 (9th cir. 2001). 86 ld. at 1348-50. 81 ld. at 1346. 88 medical injury compensation reform act of 1975 (micra), cal. civ. code§ 3333 (west 1997 & supp. 2007). 89 jackson, 980 f. supp. at 1350. 90 id. 91 see, e.g., barris v. county of los angeles, 972 p.2d 966, 973 (cal. 1999); reid v. indianapolis osteopathic med. hosp., inc., 709 f. supp. 853,855-56 (s.d. ind. 1989), cited in power ii, supra note 60, at 862-63; feighery v. york hosp., 38 f. supp. 2d 142, 158 (d. me. 1999); leev. alleghanyreg'lhosp. corp., 778f. supp. 900, 903-04(w.d. va.1991)(follow­ ing reasoning in reid). most federal courts that have addressed the issue have also applied par­ ticular state caps on malpractice damages to emt ala claims. cal. high court upholds micra damage limits, 3-7 mealey's managed careliabili1y rep. 10 (1999). 92 smith v. botsford gen. hosp., 419 f.3d 513, 519 (6th cir. 2005), cert. denied, 126 s. ct. 1912 (2006) (mem.). 93 ld. at 515. 100 indiana heal til law review [vol. 4:85 district court should be reduced according to the state's malpractice cap, which limits non-economic damages '"in an action for damages alleging medical mal­ practice' to $359,000."94 in reaching its decision, the court examined the plain language of emt ala's damages provision, which reads that "[a]ny individual who suffers personal harm as a direct result of a participating hospital's violation of a re­ quirement of [the act] may, in a civil action against the participating hospital, obtain those damages available for personal injury under the law of the state in which the hospital is located. "95 based on this language, the court reasoned that "damages available" could be interpreted broadly to mean the amount of damages for which recovery is permitted under state law because nothing in the language indicates otherwise. 96 the plaintiff argued, however, that the statute required courts to consider only the types of damages recoverable under state law, and not the amount97 the court rejected this assertion stating, "[w]e see nothing in the language of the section indicating that 'damages available' does not also mean the amount of damages for which recovery is permitted under state law. "98 the court went on to analyze the application of the state damage cap to the emtala claim, using the framework set forth in the fourth circuit deci­ sion, power v. arlington hospital ass 'n, 99 which provided that the starting point for determining whether a state damage cap applies and what damages are available is the threshold question of whether the plaintiff's emtala claim would be deemed a malpractice claim under state law.100 thus, if an emt ala claim can be deemed a medical malpractice claim under state law, it is gov­ erned by that state's medical malpractice statutes, and the damage cap provision will likely apply.101 if a court finds that the claim would not constitute a medi­ cal malpractice claim specifically, the state medical malpractice statute would not govern the emt ala claim, and the damage cap would not apply.102 the test applied by the court to determine ''whether the nature of a claim is ordinary negligence or medical malpractice" consisted of two parts: 1) "'whether [the claim] is being brought against someone who, or an entity that, is capable of malpractice"'103 and 2) whether the claim "'sounds in medical 94 id at 517 (stating that michigan's statute actually caps damages at $280,000, but this amount changes as a result of yearly adjustments; 2003 adjustment applicable in smith capped damages at $359,000); mich. comp. laws ann. § 600.1483 (west 1996 & supp. 2006). 95 smith, 419 f.3dat517 (:firstemphasisadded)(quoting42 u.s.c. § 1395dd(d)(2)(a) (2000)). 96 id. 97 id. 98 id (citing power ii. supra note 60). 99 power it, supra note 60; see discussion infra part lli.b.2. 100 smith, 419 f.3d at 518. 101 see id.; see also power ii, supra note 60. 102 seesmith,419f.3dat518. 103 id (quoting bryant v. oakpointe villa nursing ctr., inc., 684 2007] applying state damage caps to federal emt ala claims 101 malpractice. "'104 the second part of the test turns on the additional questions of"l) whether the claim pertains to an action that occurred within the course of a professional relationship; and 2) whether the claim raises questions of medical judgment beyond the realm of common knowledge and experience."105 if these questions are answered in the affirmative then the action is subject to the pro­ cedural and substantive requirements that govern medical malpractice claims.106 when analyzing the issue of medical judgment, the court stated that the distin­ guishing feature of claims involving medical judgment is the need for expert testimony.107 applying this standard, the court determined that the emtala failure-to-stabilize claim at issue in the case constituted a malpractice claim because compliance with the stabilization requirements of emt ala entails medical judgment understood only through expert testimony.108 therefore, the damages in the case were limited by the state cap. 109 2. the fourth circuit: power v. arlington hospital ass 'n ii reversing the district court's decision110 in power i, the fourth circuit also held that the plaintiff's emt ala claim was a ''malpractice claim" subject to virginia's medical malpractice damage cap.111 in its analysis, the court noted that "emt ala is not a substitute for state law malpractice actions, and was not intended to guarantee proper diagnosis or to provide a federal remedy for mis­ diagnosis or medical negligence."112 n.w.2d 864, 870 (mich. 2004)). 104 id. (quoting bryant, 684 n.w.2d at 871). 105 jd. (quoting bryant, 684 n.w.2d at 871). 106 jd.; cf. reid v. indianapolis osteopathic med. hosp., inc., 709 f. supp. 853, 854-56 (s.d. ind. 1989) (holding that the state procedural limitation requiring a medical review panel to examine a claim before going to trial does not apply to emtala claims but the substantive damage cap limitation does apply). 107 smith, 419 f .3d at 5 18 (citing bryant, 684 n .w.2d at 872) ("if the reasonableness of the health care professionals' action can be evaluated by lay jurors, on the basis of their common knowledge and experience, it is ordinary negligence. it on the other hand, the reasonableness of the action can only be evaluated by a jury only after having been presented the standards of care pertaining to the medical issue before the jury explained by experts, a medical malpractice claim is involved."). 108 id. under emtala, the health care provider must stabilize to the extent that it is assured, ''within reasonable medical probability, that no material deterioration of the condition is likely .... " 42 u.s.c. § 1395dd(ex3xa) (2000) (emphasis added). 109 smith, 419 f.3d at 519. 110 see supra part lll.a.l. 111 power ii, supra note 60, at 860. the plaintiff in this case "cleverly" framed her action under emtala instead of suing in state court under the medical malpractice statute. bardot, supra note 67, at 249, 255. 112 power ii, supra note 60, at 856 (citing brooks v. maryland gen. hosp., inc., 996 f .2d 708,710 (4th cir. 1993); baberv. hosp. corp. of am., 977 f.2d 872, 880 (4th cir. 1992)). 102 indiana health law review [vol. 4:85 by including the emt ala damages provision,113 the court stated that congress explicitly directed federal courts to look to state law in the state where the hospital is located to determine both the type and amount of damages avail­ able in emtala actions.114 therefore, to determine whether the state mal­ practice cap applied, the court focused on the threshold issue of whether the plaintiff's emtala claim would be deemed a malpractice claim under vir­ ginia's medical malpractice statute.115 clarifying this issue, the court stated that its initial inquiry was whether virginia's malpractice cap would apply to a per­ sonal injury claim against a hospital that alleges a disparate provision of health care services, but does not allege a breach of the prevailing standard of care. 116 the court in power ii first relied on three virginia supreme court cases in its statutory construction and general reasoning.117 this precedent demon­ strated, according to the circuit court, the virginia supreme court's desire to broadly construe the statutory language enacted by the virginia general as­ sembly in defining a cause of action for malpractice.118 first, in glisson v. loxley, the virginia supreme court held that the pa­ tient's battery claim was subject to the requirements ofvirginia's medical mal­ practice statute because battery is a tort.119 the statute defined malpractice as "any tort based on health care."120 therefore, although the battery claim was covered by the malpractice statute, the patient's breach of contract claim was nott2t . second, in gonzalez v. fairfax hospital system, inc., the court held that a suit against a hospital for negligence122 constituted a malpractice claim under virginia's statute because the alleged negligent acts occurred while the patient was receiving treatment or "health care" as a patient at the hospital.123 in addi­ tion, "the alleged tort was based on 'health care or professional services ren­ dered ... to a patient,' which constitutes 'malpractice'," and the hospital was a health care provider.124 thus, applying a broad, plain meaning approach to the 113 for the exact language of the provision, see supra text accompanying note 40. 114 power ii, supra note 60, at 860. 115 /d. (citing brooks, 996 f.2d at 713). 116 id at 860-61 (citing brooks, 996 f.2d at 713). 117 see id. at861 (citinggonzalezv. fairfaxhosp. sys. inc., 389 s.e.2d458 (va.l990); hagan v. antonio, 397 s.e.2d 810 (va 1990), superseded by statute, va. code ann.§ 8.01581.2 (1993); glisson v. loxley, 366 s.e.2d 68 (va 1988), superseded by statute, va. code ann.§ 8.01-581.2 (1993)). 118 id (glisson and hagan interpreted a prior version ofvirginia's medical malpractice statute, as stated in mcdonald v. hoard, 48 va cir. 421, 427 (1999)). 119 glisson, 366 s.e.2d at 72, cited in power ii, supra note 60, at 861. 120 /d., quoted in power ii, supra note 60, at 861. 121 /d., cited in power ii, supra note 60, at 861. 122 the plaintiff alleged that he was injured in a whirlpool tub by a metal object during physical therapy. gonzalez, 389 s.e.2d at 458. 123 id at 459. 124 ld (quoting va. code ann.§ 8.01-581.1 (1990)). 2007] applying state damage caps to federal emt ala claims 103 statute, the court found that the malpractice statute's requirement that a defen­ dant receive notice of a claim applied to the plaintiffs emt ala claim.125 finally, in hagan v. antonio, the court held that an allegation of improper sexual conduct by a physician during his physical examination of a patient was an action for "malpractice" requiring the statutory notice provided in virginia's medical malpractice statute.126 according to the court, the defendant physi­ cian's conduct constituted malpractice because "legitimate or improper, [it] was 'based on' an 'act' by a health care provider to 'a patient during the patient's medical . . . care. "'127 thus, the defendant's alleged tortious conduct was "based on health care or professional services rendered," within the meaning of the state's malpractice statute because it "stemmed from, arose from, and was 'based on' the performance of a physical examination."128 this interpretation of the type of conduct required to constitute malpractice under the statute also suggests and further supports a broad reading of this particular malpractice statute. applying the same broad interpretation to the plaintiff's emtala claim, the court in power ii concluded that it would be deemed a malpractice claim under the state's medical malpractice statute.129 the court reasoned that the conduct that formed the basis of the plaintiff's emt ala claim occurred while the plaintiff was receiving ''health care" from a health care provider, as defined by the statute.13° furthermore, the court found that the tort alleged in the plain­ tiff's emt ala claim was "based on health care or professional services ren­ dered, or which should have been rendered ... to a ratient,"131 thus falling within the state's statutory definition of malpractice.13 the fourth circuit further emphasized that emtala was not intended only to incorporate damage caps for personal injury claims. rather, courts should determine whether the underlying conduct and the legal basis for the claim would be encompassed within the state's personal injury damage cap, the medical malpractice damage cap, both, or neither, if brought under state law.133 the problem with this interpretation, as the fourth circuit noted, is that the damages available under emtala will vary from state to state according to the type and amount of the state's damage caps.134 the court reasoned, how­ ever, that this result is unavoidable because it is inherent in § 125 jd at 459-60. 126 hagan v. antonio, 397 s.e.2d 810, 812 (va. 1990),superseded by statute, va. code ann.§ 8.01-581.2 (1993). 127 jd., quoted in power ii, supra note 60, at 861. 128 !d. at 811-12. 129 power ii, supra note 60, at 861. 130 !d. 131 !d. 132 ld 133 id at 863. 134 ld 104 indiana health law review [vol. 4:85 1395dd(d)(2)(a)'s explicit direction that courts look to state law to determine what damages are available. 135 furthermore, while the fourth circuit agreed that the language in§ 1395dd( d)(2)(a) applies to elements of damages, nothing in the language of the section indicated that "damages available" did not also mean the amount of damages for which recovery is permitted under state law.136 moreover, the fourth circuit disagreed with the district court in its assertion that congress was required to explicitly refer to or limit malpractice damage caps in order for§ 1395dd(d)(2)(a) to incorporate state malpractice damage caps.137 rather, § 1395dd(dx2)(a) reflected congress's deliberate choice to use the more general and inclusive phrase "personal injury" so that it would not have to explicitly refer to "each and every type oflimitation on damages, e.g. limitations on punitive damages, noneconomic losses, and malpractice damage caps, that the states might have enacted."138 thus, congress was not required to refer specifically to malpractice damage caps or to use other explicit limiting language in order to incorporate such limits. 139 the fourth circuit also pointed to the legislative history to support this in­ terpretation.140 when the bill was initially proposed, there were no limitations on the damages provision.141 there were concerns, however, regarding "the potential impact of these enforcement provisions on the current medical mal­ practice crisis" and that smaller hospitals would have to close their emergency rooms if the emtala penalties were too severe. 142 thus, in subsequent modi­ fications of the bill, on the issue of damages, the courts were directed to "apply the law of the state in which the violating hospital is located, for actions brought by a harmed individual .... "143 thus, the fourth circuit concluded that congress "'was clearly aware of a growing concern in some states that ex­ cessive damage awards were fueling a medical malpractice "crisis" ... "'144 and therefore had wanted to preserve state-enacted ceilings on the amount of dam135 !d. 136 !d. at 862. 137 jd. 138 !d. (citing an amicus brief prepared by the virginia hospital association); accord barris v. county of los angeles, 972 p.2d 966, 973 (cal. 1999) (holding that emtala ex­ pressly incorporates state substantive limits on "damages available for personal injury,'' 42 u.s.c. § 1395dd( d)(2)(a) (2000), because congress's choice of"personal injury" was intended to be inclusive, such that emt ala incorporates not only general provisions for personal injury damages but also specific provisions such as limits applicable to malpractice damages). 139 power ii, supra note 60. 140 ld. 141 id. 142 /d. (citing h.r. rep. no. 99-241, pt. 3, at 6 (1985)). 143 id. (citing h.r. rep. no. 99-453, at 476 (1985) (conf. rep.)). 144 /d. (quoting reid v. indianapolis osteopathic med. hosp., inc., 709 f. supp. 853, 855 (s.d. ind. 1989)). 2007] applying state damage caps to federal emt ala claims 105 ages that could be recovered under emtala through the incorporation clause of§ 1395dd( d)(2)(a). 145 in addition, the fourth circuit disagreed with the district court's views on the goals ofemt ala and the virginia malpractice statute. emt ala's pre­ emption provision states: "the provisions of this section do not preempt any state or local law requirement, except to the extent that the requirement directly conflicts with a requirement of this section."146 the district court implicitly concluded that the state damage cap was preempted under§ 1395dd(f) by find­ ing that emt ala's objectives of compensation and deterrence conflicted with the virginia statute's goal of promoting insurance availability and afforda­ bility.147 however, the fourth circuit disagreed with this conclusion and rea­ soned that emtala·and the state damage cap are not necessarily mutually exclusive simply because the overall purpose ofemt ala differs from the lim­ ited purpose of the malpractice damage cap.148 when enacting any legislation, including emt ala, congress must bal­ ance a number of conflicting concerns.149 as the united states supreme court has observed, [n]o legislation pursues its purposes at all costs. decid­ ing what competing values will or will not be sacrificed to the achievement of a particular objective is the very essence of legislative choice-and it frustrates rather than effectuates legislative intent simplistically to as­ sume that whatever furthers the statute's primary objec­ tive must be the law.150 thus, the fourth circuit reasoned that emtala's damages provision151 was congress's attempt to balance the deterrence and compensatory goals of emt ala with deference to the ability of states to determine what damages are appropriate in order to avoid sacrificing either value completely.152 in addition, according to the fourth circuit, ''the appropriate inquiry for purposes of determining whether emtala preempted virginia's statute under 145 id. at 862-63 (quoting reid, 709 f. supp. at 855); see supra note l 06 and infra note 181 (discussing reid in further detail); see also lee v. alleghany reg'l hosp. corp., 778 f. supp. 900, 903-04 (w.d. va. 1991) (following the reasoning of reid to hold that an emf ala plaintiff's recovery was limited by virginia's cap on medical malpractice damages). 146 42 u.s.c. § 1395dd(f) (2000); power ii. supra note 60, at 863 n.io. 147 power ii, supra note 60, at 863 (citing power i, supra note 59, at 1389). 148 id. 149 id iso rodriguez v. united states, 480 u.s. 522, 525-26 (1987), quoted in power ll, supra note 60, at 863. lsi § 1395dd(dx2)(a). !sl power ii. supra note 60, at 863. 106 indiana health law review [vol. 4:85 § 1395dd(f) would be whether the actual cap of one million dollars 'directly conflicts' with the goals ofemtala."lsj the court found that there was no direct conflict. 154 finally, even if there was a direct conflict, the court con­ cluded that a preemption analysis was not necessary because the federal statute, emt ala in this case, expressly incorporates state law in its damages provi­ sion.155 in conclusion, the court deemed ms. power's emt ala claim a malprac­ tice claim under the virginia medical malpractice act for the purpose of apply­ ing the damage cap, despite the fact that it did not allege a breach of the prevailing professional standard of care generally associated with a malpractice claim.156 because the emt ala claim fell within the coverage of the malprac­ tice cap, the court limited the plaintiff's recoverable damages to one million dollars.157 ultimately, the fourth circuit's decision to reverse the district court and find that state damage caps applied to the emt ala claim avoided multi153 /d. at 863-64. 154 /d. at 864. iss /d.;§ 1395dd(d)(2)(a). 156 power ii, supra note 60, at 861. the plaintiff did not claim negligence or more spe­ cifically, a breach of duty on the part of the hospital; rather, she alleged the hospital violated several emtala requirements. power i, supra note 59, at 1387 n.6; see supra note 62 and accompanying text. emt ala requirements providing for civil enforcement by an individual are imposed under a strict liability standard, not negligence. power i, supra note 59, at 1387 n.6 (citingabercrombiev. osteopathichosp. foundersass'n, 950f.2d676, 681 (loth cir. 1991)). in order for the plaintiff to prove that the hospital did not provide her with an appropriate medi­ cal screening, she must show that the screening was not as thorough or careful as that which the hospital would have provided to any other patient. /d. this may be established through proof of a failure to adhere to the hospital's standard protocols, or, where no such standard protocols exist, proof of a failure to meet the standard of care to which the hospital adheres. /d. in this second instance, the district court in power i recognized that the line between malpractice and an emtala violation "blurs somewhat." /d. thus, it is possible for a violation to constitute both an emtala violation and medical malpractice (where one requirement under a standard for an appropriate medical screening is not met), or only medical malpractice {in an instance where all requirements under a certain standard are satisfied but the incorrect conclusion is made). /d. 157 power ii, supra note 60, at 861. the court also noted that its holding in power ii did not contradict its holdings in brooks v. maryland general hospital, 996 f.2d 708 (4th cir. 1993), and bober v. hospital corp. of america, 977 f.2d 872 (4th cir. 1992). id. at 864. in these cases the court concluded that emtala was not intended to displace state malpractice law and its purpose was not ''to guarantee that all patients are properly diagnosed, or even to ensure that they receive adequate care." /d. rather, the court emphasized its adherence to these holdings and agreed with the district court's view in power i that there are "'sharp differences between a medical malpractice action and an emtala action,' and that '[t]hey are separate and distinct causes of action focused on different conduct and aimed at different goals."' /d. ( quot­ ing powers i, supra note 59, at 1390). nevertheless, in order to interpret emtala's damages provision, analyzing whether an emtala claim would be deemed a malpractice claim under the applicable state law most closely follows congress's direction that courts should look to state law to determine what damages are available in an emtala action. /d.; see h.r rep. no. 99-453, at476 (1985) (conf. rep.). 2007] applying state damage caps to federal emtala claims 107 ple adverse effects and negative policy implications.158 its decision gave effect to the plain language ofemtala's damages provision while not unduly bur­ dening hospitals or jeopardizing the availability of health care in general. 159 iv. promoting accessible, affordable, and high quality health care: key policy reasons for applying state medical malpractice damage caps to emt ala claims courts agree that emt ala is not technically considered a medical mal­ practice statute and therefore does not create a cause of action based on profes­ sional negligence or medical malpractice.160 emtala "is not a federal malpractice statute and it does not set a national emergency health care stan­ dard; claims of misdiagnosis or inadequate treatment are left to the state mal­ practice arena.''161 emtala claims are not based on whether a hospital was negligent; rather, they are based on strict liability and are, therefore, distin­ guishable from state medical malpractice statutes in which the plaintiff typically must prove the traditional medical malpractice tort claim by showing the pro­ vider was negligent. 162 emt ala provisions were not intended to comprise a "federal medical malpractice act.''163 the very reasons for which courts have refused to construe emt ala as creating a federal cause of action for medical malpractice, 164 however, are the precise reasons why state damage caps should be applied to emtala claims in addition to state medical malpractice claims. although it may seem counter­ intuitive to argue simultaneously that emt ala is not a federal medical mal­ practice statute and that state damage caps should be applied to emtala claims, one must focus on the underlying principles and policy implications associated with construing emt ala as distinct from state medical malpractice 158 see infra part iv. 159 c. celeste creswell, power v. arlington hospital association: extending cobra's striking distance while weakening the power oflts venom, 29 ga. l. rev. 1171, 1174 (1995). 160 summers v. baptist med. ctr. arkadelphia, 91 f.3d 1132, 1137 (8th cir. 1996). 161 id. 162 see id. medical malpractice claims, however, may also be based on intentional tort or strict liability theories. see, e.g., anderson v. prease, 445 a.2d 612 (d.c. 1982) (medical malpractice claim based on a theory of intentional infliction of emotional distress); hoven v. kelble, 256 n.w.2d 379 (wis. 1977) (medical malpractice claim based on a theory of strict liability, although court ultimately refused to apply that theory). 163 power i, supra note 59, at 1387 n.6 (allowing the plaintiff to bring a seemingly traditional malpractice action under emtala because plaintiff emphasized that she was not only misdiagnosed but was also inappropriately transferred to a different hospital). 164 such reasons include the following: to prevent forum shopping and the expansion of avenues through which plaintiffs may bring medical malpractice suits and to protect health care providers from being exposed to even greater liability by being liable under both state and fed­ eral law for medical malpractice. 108 indiana health law review [vol. 4:85 laws as well as the legislative purpose and goals for enacting emt ala in the first place. it would be much too simplistic to conclude that because emt ala is not considered a federal medical malpractice statute, damage caps applicable to state medical malpractice claims should not apply to claims brought under emt ala. this would be inconsistent with not only the policy behind con­ gress's enactment ofemtala, but also the policy considerations that have supported medical malpractice reform efforts in many states and the language ofemtala that explicitly directs courts to look to state law in order to deter­ mine what damages are available.165 the negative policy implications of failing to incorporate damage caps on emt ala claims are significant and would heavily impact health care providers and health care consumers alike by affect­ ing the affordability, accessibility, and quality of health care in the united states. furthermore, it would be a large step backward in the nationwide effort to improve state medical malpractice environments for health care providers. a. incorporating damage caps will prevent plaintiffs from circumventing state damage caps by bringing their state malpractice claims in fed­ eral court under emtala damage caps should be applied to emtala claims in order to prevent plaintiffs from manipulating their claims into patient dumping actions merely to circumvent the recovery caps under traditional state medical malpractice stat­ utes.166 applying damage caps to emt ala claims that are actually based on malpractice-like conduct limits the plaintiff's potential monetary award, regard­ less of whether he or she files suit in federal court under the guise ofemt ala or in state court under the medical malpractice statute. this removes some of the incentive plaintiffs would have to manipulate a traditional malpractice claim into an emtala action simply to avoid the state damage caps, with the hope of recovering more than the cap allows.167 moreover, framing a suit under emtala will all()w a plaintiff to recover under strict liability, 168 relieving the plaintiff of the burden of proving negli­ gence, as is typically required with traditional malpractice suits.169 lowering the burden of proof provides plaintiffs another incentive to file in federal court under emt ala and likely renders it easier for plaintiffs to obtain a verdict in 165 see42 u.s.c. § l395dd(dx2)(a)(2000); h.r. rep. no. 99-453, at476 (1985)(con£ rep.) 166 arguably, the plaintiff engaged in this type of manipulation in power i because the facts presented in the case did not clearly support an emtala claim. and it was questionable whether the plaintiff was actually dumped. bardot, supra note 67, at 255,260-61. for more discussion and analysis of power i generally, see id at 255. 167 see id 168 /d. at 262 n.108. 169 ld at 257 n.77. 2007] applying state damage caps to federal emtala claims 109 their favor. 170 permitting plaintiffs to circumvent the traditional burden of proof requirements will also exacerbate the malpractice crisis occurring in this country, where malpractice insurance carriers will charge providers higher pre­ miums either to safeguard against and cover the costs of potential future claims or to recoup the costs of defending past actions or paying out prior judg­ ments.171 this increased cost will be passed along to patients, many of whom are frequently unable to afford health care in the first place. individual con­ sumers will be forced to absorb these costs to the detriment of the health care system. 172 finally, merely pleading theories of"non-negligence," such as emt ala violations, should not allow plaintiffs to circumvent state medical malpractice statutes' damage caps. 173 not applying a state damage cap to emt ala claims would provide plaintiffs with the opportunity to avoid such a state limitation simply because he or she chose to pursue a cause of action for both professional negligence and a violation ofemt ala. 174 there is not a meaningful or legally sound reason, however, for allowing circumvention of state damage caps on those grounds. this would result in plaintiffs simply crafting their complaints in a way that implicates "non-negligence" or strict liability, the standard upon which emt ala is typically based, so as to avoid application of a state damage cap.175 moreover, there would be further claim manipulation and uncertainty as no id. 171 see richard e. anderson, the case for legal reform, in medical malpractice: a physician's sourcebook 208 (richard e. anderson ed., humana press 2004) [hereinafter anderson, the case for legal reform] ("insurers must collect premium today to pay for the cost of claims in the future."). it is the insurance company's fiduciary responsibility to invest premium dollars carefully so that funds will be available to pay claims when needed. /d. 172 bardot, supra note 67, at 262. 173 see cal. health professionals urge court to uphold micra damage limits 3-3 mealey's managed care liability rep. 12 ( 1999) (discussing barris v. county of los ange­ les, 972 p.2d 966 (cal. 1999)). in barris, the plaintiff sued the county hospital, claiming that the hospital violated emtala by failing to stabilize the patient, her eighteen-month-old daughter, before transfer. barris, 972 p.2d at 969. the california supreme court ultimately upheld the trial court's decision, stating the damages award was subject to the state's limit because it broadly applied to causes of action based on professional negligence. i d. at 97 4. the court applied the approach often taken by federal courts by determining whether an emt ala claim, if brought under state law, would constitute an "action for injury against a health care provider based on professional negligence." !d. according to the court, a failure-to-stabilize claim under emt ala was necessarily based on professional negligence. i d. furthermore, the "apparent intent of congress was to balance the deterrence and compensation goals of emt ala with deference to the ability of states to determine what limits are appropriate in personal injury actions against health care providers." !d. at 973. 174 cal. health professionals urge court to uphold .micra damage limits, 3-3 mealey'smanagedcareliabilityrep.l2 (1999). 175 id. 110 indiana healtii law review [vol. 4:85 to whether the state damage cap would apply in cases where plaintiffs assert alternative legal theories to negligence, such as violations of emt ala. 176 b. incorporating damage caps will prevent forum shopping another reason, related to the manipulation of claims, that damage caps should be applied to emt ala claims is to prevent forum shopping. decisions in which courts have found state damage caps are not incorporated by emtala simply serve to promote this practice, which courts have generally sought to discourage since erie railroad co. v. tompkins.111 potentially, a plaintiff would have an incentive to file an emt ala suit based on malprac­ tice-type conduct in federal court because he or she would be able to avoid the state damage caps that would be applied in state court, even though state courts have traditionally heard such claims sounding in medical malgractice. plaintiffs could simply frame a claim, which seems to be a typical medical malpractice action, in a manner that suggests patient dumping or another viola­ tion ofemt ala, in order to fit within the emtala framework and evade the malpractice damage cap to potentially obtain a higher award.178 a plaintiff would then have several venue options and could choose either a federal or state court according to what is most favorable to his or her case in general, in addition to the greater possibility of receiving more money for damages. filing the claim in federal court would obviously be the more desirable option for plaintiffs if they could avoid damage caps in that forum. thus, plaintiffs would more often file in federal court, overloading federal dockets and quickly ex­ haustingjudicial resources on claims typically handled by state courts. in addi­ tion, if a plaintiff still filed in state court, the inapplicability of damage caps to emtala claims would discourage a defendant from removing to federal court, even when there was a compelling reason to do so, because of the risk of a higher verdict against him or her. furthermore, this would conflict with the legislative purpose behind state medical malpractice statutes as well as the con­ gressional purpose behind emt ala to ease the liability crisis and to ensure access to health care. 179 c. incorporating damage caps furthers the purposes of emtala and state medical malpractice statutes in addition, limiting certain emt ala claims with damage caps would . further the goal ofemt ala to ensure access to health care, especially to indi'176 id 177 erier.r. co. v. tompkins.304 u.s. 64(1938)(establishingthepoliciesofavoiding forum shopping and different results depending on the forum in which the case is tried), cited in bardot, supra note 67, at 260 & n.94. 178 bardot, supra note 67, at 261. 179 jd at 261-63. 2007] . applylngstatedamagecapstofederalemtalaclajms 111 gent and uninsured patients. by keeping recoveries at certain levels, overall health care costs can remain low or at least relatively stable because providers will be subject to less liability, and as a result. medical malpractice insurance premiums will level off or possibly decrease. this is similar to the goals of many state medical malpractice statutes. 180 furthermore, at the time congress drafted emtala, it was clearly aware of the increasing concern in some states that excessive damage awards were causing a medical malpractice crisis.181 in response to this crisis, many states had enacted limits on the amount of damages that could be recovered.182 thus, through the incorporation clause ofemt ala, congress likely wished to pre­ serve those limits on damages. 183 in addition, in the context of the underlying policies and purposes of emt ala and state malpractice statutes, it would be consistent to apply state damage caps to emt ala claims sounding in medical malpractice. although the court in power i asserted that the purposes ofemtala and the virginia statute were conflicting, this was an erroneous conclusion because their pur­ poses can actually be considered complementary.184 both the federal emt ala statute and state malpractice statutes serve to ensure health care for all individu­ als, regardless of their ability to pay.185 for example, at issue in power, vir­ ginia's malpractice statute served to combat rising premiums for medical malpractice insurance, which is directly related to the purpose of ensuring uni­ versal access to adequate medical care underlying emt ala.186 failing to con­ sider this would greatly undercut the availability ofhealth care to all individuals because it would open up yet another floodgate of litigation and thus would place more liability on health care providers, ultimately contributing to the al­ ready surging medical liability crisis in america. also, applying a damage cap to emt ala claims will encourage potential plaintiffs to consider whether the limited available damages justify the costs of litigation.187 this would help to prevent a flood ofemtala claims, in addi­ tion to simply frivolous emt ala claims. one of the primary causes of the medical malpractice crisis in many states is the rising cost of defending claims combined with the high frequency of claims.188 both of these factors would be 180 see id. 181 see h.r. rep. no. 99-241, pt. 3, at 6 (1985), cited in power ll, supra note 60; reid v. indianapolis osteopathic med. hosp., inc., 709 f. supp. 853, 855 (s.d. ind 1989) (holding that emtala incorporates state substantive limitation on the maximum amount recoverable from a health care provider because to hold otherwise would render the incorporation clause of § 1395dd(dx2xa) meaningless). 182 reid, 109 f. supp. at 855. 183 /d. 184 bardot, supra note 67, at 258. iss id 186 id 187 creswell, supra note 159, at 1172. 188 anderson, defending the practice, supra note 11, at 1177. 112 indiana health law review [vol. 4:85 exacerbated if plaintiffs were given the option of pursuing an emt ala claim without the damage cap limits. it is likely that plaintiffs will be more inclined to file such claims where there is a limitless potential for recoverable damages. thus, even if the plaintiff does not prevail, the excessive litigation will still im­ pose considerable costs on physicians who must defend such suits.189 this de­ fense cost must then be calculated into the cost of insurance.190 finally, if damage caps are not applied to emtala actions, physicians facing malpractice suits will potentially see higher payouts to plaintiffs under emt ala, in comparison to state medical malpractice statutes that provide a damage cap. also, more plaintiffs will ftame their complaints under emt ala because of the possibility of higher payouts, or, in the alternative, if they are simply unhappy with the recovery limits placed on malpractice claims by state law.191 consequently, failing to apply damage caps to emt ala claims will increase the frequency of claims filed against physicians. v. conclusion because of the ambiguity in emt ala's damages provision, courts have gone in both directions on whether state damage caps shall apply to emt ala claims. however, the majority of courts have found that state damage caps are applicable to emt ala claims. this has prevented forum shopping and the manipulation of malpractice-based claims into emtala claims in many juris­ dictions. in addition, this majority position is consistent with the underlying policies and purpose ofemtala and state medical malpractice statutes: to ensure adequate access to and quality of health care to all in the united states by limiting the liability physicians face in their practices, which in turn results in lower malpractice insurance premiums for physicians and lower medical costs for consumers. by controlling the cost of insurance, physicians will not have to pass on as much of the cost of expensive insurance to their patients, making health care more accessible to patients, regardless of their financial status. in addition, the practice of defensive medicine will decrease with the diminished fear ofbeing sued and facing excessive or unlimited jury verdicts. finally, physicians will be more satisfied with the practice of medicine and will be less likely to relocate or stop practicing, both of which could disrupt the continuity of care. 192 ulti­ mately, this will result in higher quality health care, preserve access to treat189 /d. at 1174. 190 jd in the united states, the average cost of defending one lawsuit is $22,967, id, and if a case goes through a jury trial before a verdict for the defendant, it can cost over $85,000. anderson, effective legal reform, supra note ll, at 345-46. the total cost of medical malpractice litigation in the united states now exceeds twenty-four billion dollars each year and continues to increase. /d. at 347. 191 bardot, supra note 67, at 262. 192 anderson, effective legal reform, supra note ll, at 353. 2007] applying state damage caps to federal emt ala claims 113 ment, and promote a stable insurance market.193 in contrast, the likely primary effect, although probably unintended, of not applying state damage caps to emt ala claims, which could also be framed as malpractice claims, is that potential plaintiffs will be permitted to bypass the state damage cap simply by framing a seemingly malpractice-based claim as an emt ala claim. the amount of a possible recovery would be limitless. while this seems to be a broad interpretation ofemtala's damages provision, such a reading is necessary to effectuate the plain language of the provision and the policies underlying both emtala and state medical mal­ practice statutes. a narrow reading that does not incorporate state damage caps would have an adverse impact on both the federal and state legislatures' pri­ mary objective to promote high quality, accessible, and affordable health care. thus, the incorporation of state damage caps into emt ala is beneficial at the local level for medical liability and general tort reform, as well as at the national federal level. in addition to the policy arguments, however, it should be considered that many courts base their broad interpretations and incorporation on the plain lan­ guage of emt ala, aside from or in addition to the policy implications.194 therefore, if incorporation of state damage caps is in fact determined primarily by the plain language ofemtala's damages provision in future decisions, narrowing the scope ofemt ala's damages provision or modifying the appli­ cation of state malpractice statutes may have to be left to congress or state leg­ islatures.195 in conclusion, it is imperative that courts keep in mind the probable policy implications and potential adverse effects on access to and quality ofhealth care when interpreting the damages provision ofemt ala and its incorporation of state malpractice damage caps. by following the majority approach to incorpo­ rate such damage caps, courts can avoid possible adverse effects on health care and simultaneously promote progress in tort reform generally, as well as pro­ gress in the context of medical malpractice liability. ultimately, such an ap­ proach will be beneficial to health care consumers and will serve to diminish the crisis occurring in the area of medical malpractice liability by decreasing and controlling malpractice insurance costs, fostering patient access to medical treatment, and promoting a higher quality of health care in america. 193 id at 354. 194 see smith v. botsford gen. hosp., 419 f.3d 513,517 (6th cir. 2005), cert. denied, 126 s. ct. 1912 (2006) (mem.); see also discussion supra partlli.b.l. 195 see gonzalez v. fairfax hosp. sys. inc., 389 s.e.2d 458, 460 (va. 1990); see also supra text accompanying notes 122-25. dances with elephants: administrative resolution of medical injury claims by medicare beneficiaries eleanor d. kinney, jd, mph* william m. sage, md, jd** table of contents i. introduction .••••.•••••••.•••••••••.•..•••.•..•••.•.••••••••••.••.••••..•.••••••••••...••••••••••••.• l ii. medicare's presumption of expertise ............................................. 2 ill. relnventing complaint review as administrative compensation for injury .............................................................. 6 iv. the need for "disruptive regulation" in medicare ................... 7 i. introduction the stated purpose of hoffmann and rowthorn's excellent analysis of the statutory mechanism for addressing quality of care problems in the medicare program is to "add to the debate about the most appropriate home for the [pro­ gram's] beneficiary complaint process."1 in the process of doing so, they cata­ log persistent inadequacies in this process that date from its inception and that have not been remedied by its current placement within medicare's quality improvement organizations ("qios"). 2 * hall render professor of law and co-director, center for law and health, indiana university school oflaw-indianapolis; mph, university ofnorth carolina at chapel hill; j.d., a.b., duke university school of law. ** vice provost for health affairs and james r dougherty chair for faculty excellence, the university of texas at austin; a.b., harvard college; m.d., j.d., stanford university. i. diane e. hoffinann & virginia rowthorn, achieving quality and responding to con­ sumers the medicare beneficiary complaint process: who should respond? 5 ind. heal'ihl. rev. 9, 9 (2008). 2. the seeds of the current qio process were planted in the peer review improvement actofl982,pub. l. no. 97-248, § 143, §§ 1151-1163,96 stat. 324(1982). handling benefici­ ary complaints bas been a qio responsibility since 1995, when congress specifically required it. 42 u.s.c. § 1320c-3(a) (2000). the function became a more prominent aspect ofqios' con­ tractual scope of work following a 2001 report by the office of inspector general of the us department of health and human services. dhhs office oflnspector gen., pub'n no. oei· 01-00-00060, 'fim medicare beneficiary complaint process: a rus1y safety valve (2001 ), available at http://oig.hhs.gov/oeilreports/oei-01-00-00060.pdf[hereinafter 2001 010 report]. 2 indiana health law review [vol. 5:1 hoffman and rowthorn review reports from the office of inspector gen­ eral of the u.s. department of health and human services ("oig"i and the institute of medicine (''iom"t finding qios' management ofbeneficiary com­ plaints to be severely lacking. the iom recommended that the centers for medicare and medicaid services ("cms") consolidate the beneficiary com­ plaint and review functions into a few regional or national organizations awarded competitive contracts or locate these functions in state health depart­ ments and/or licensing bodies. 5 echoing the iom, hoffinann and rowthorn's preferred alternative is to outsource resolution of medicare beneficiaries' complaints to state boards of medicine and institutional survey and certification authorities, who perform similar functions on a larger scale. tellingly, many state disciplinary officers hoffmann and rowthorn interviewed were unaware that medicare qios even processed patient complaints, and one state regulator who contacted the qio in his area regarded that organization's low self-reported caseload as "somewhat comical. "6 in our judgment, hoffmann and rowthorn' s research clearly demonstrates that the qio-based complaint review process does not provide genuine relief to beneficiaries. people who complain typically want an explanation of their bad experience, compensation for harm they may have suffered, and assurance that future experiences will be better for themselves and for others. medicare bene­ ficiaries, however, receive minimal information about the resolution of their complaints and no substantive relief whatsoever. as hoffmann and rowthorn point out, several reform proposals are now before congress, including moving the beneficiary complaint function from qios to new "medicare provider review organizations."7 it is not clear from the authors' analysis what is motivating bipartisan interest in reform, but it seems to involve potentially conflicting concerns about lack of consumer re­ sponsiveness, on one hand, and wasteful bureaucracy, on the other. ii. medicare's presumption of expertise we believe that one cannot suggest meaningful improvements to a process hardly anyone uses, because it is more or less useless without trying to under3. see dhhs office of inspector gen., publ'n no. oei-01-93-00250, the beneficiary complalnt process of the medicare peer review organizations (1995), available at http:/ /oig.hhs.gov/oei/reports/oei-0 l-93-00250.pdf; 2001 oig report, supra note 2. 4. inst. of med., medicare's quality improvement organization program: maximizing potential (national academic press 2006) [hereinafter 2006 iom report]. 5. 2006 iom report, supra note 4, at 112-15. 6. hoffinann & rowthorn, supra note 1. at 42. 7. see continuing the advancement of quality improvement act of2007, s. 1947, 11 oth cong. (2007); the medicare quality improvement organization modernization act of 2007, s. 2396; 11 oth cong. (2007); medicare quality improvement organization moderniza­ tion act of2007, h.r. 1046, i loth cong. (2007). 2008] dances with elephants 3 stand how things got that way. imagine a ballroom dance. nicer invitations won't draw guests to a party with no music, bad food, and a dance floor the size of a postage stamp. there is an elephant in medicare's ballroom that frightens the musicians, devours the refreshments, and crowds the dancers. call it the presumption of expertise. 8 medicare was enacted in 1965 with the grudging support of american physicians,9 who persuaded the program's architects to accept two assertions as fact and draft legislation accordingly. 10 one was that physicians were finan­ cially incorruptible; the other was that physicians were clinically competent. few observers believed even at the time that the medical profession would be immune to monetary temptation, but the robustness of its appetite for resources was nonetheless surprising. 11 as wilber cohen, then secretary of the health, education and welfare, said: "[t]he ideological and political issues between 1960 and 1965 were so dominating that they precluded consideration of issues such as reimbursement alternatives and efficiency options."12 consequently, medicare has spent the last thirty years, through payment policy and criminal enforcement as well as professional peer review, trying to distinguish patient advocacy from moral hazard and fraud as sources of clinical cost­ ineffectiveness. 13 medicare's presumption of expertise manifests itself in three ways with respect to the beneficiary complaint process. first, the complaint process was designed to focus on individual physicians, ignoring the organizational struc8. less charitable characterizations might focus on such matters as the political power of organized medicine, the trench warfare between business and the trial bar over tort reform, and the behind-the-scenes influence of medicare contractors, including qios themselves. 9. social security amendments of 1965, pub. l. no. 89-97, 79 stat. 286 (codified as amended at 42 u.s.c. 18 §§ 1395-1396). see jumm m. feder, medicare: the politics of federal hospital insurance (1977); sylvia law, blue cross c what went wrong? (2d ed. 1976); theodore marmor, the politics of medicare (1973); robert j. myers, medicare (1970). 10. indeed, the opening section of the social security amendments of 1965 so reflects these assertions: nothing in this title shall be construed to authorize any federal officer or employee to exercise any supervision or control over the practice of medi­ cine or the manner in which medical services ... or to exercise any super­ vision or control over the administration or operation of any such institution, agency, or person. 42 u.s.c. 18 § 1395(a). 1 l see william d. fullerton, politics of federal health policy, 1960-1975: a perspec­ tive, healm care fin. rev., winter 1996, at 169; marian gornick et al., twenty years of med­ icare and medicaid; covered populations, use of benefits, and program expenditures, realm care fin. rev., 13, 35-45 (supp. 1985). see also staff of senate comm. on fin., medicare and medicaid: problems, issues, and alternatives, 91st cong., 1st sess. 53, 140-43 (comm. print 1970). 12. wilber cohen, reflections on the enactment of medicare and medicaid, 7 realm care fin. rev. 3, 5 (supp. 1985). 13. see david a. hyman, health care fraud and abuse: market change, social norms, and "the trust reposed in the workmen, " 30 j. legal stud. 531, 531 (200 1 ). 4 indiana healm law review [vol. 5:1 tures used to deliver health care. second, the process assumes that most layper­ sons' complaints involve issues tangential to ''true" quality. third, the process regards malpractice litigation as an illegitimate quality improvement device and therefore considers serving plaintiffs' interests to be a perversion of its core purpose. an additional premise underlying peer review is that medical quality can only be judged by the medical profession itself. these premises turned out to be wrong. two decades of health services research have revealed unexpected deficiencies in the modal quality of ameri­ can medical care. population health indicators in the u.s. substantially trail most european countries and other english-speaking countries, the burden of preventable chronic disease is high and rising, adherence to clinical best prac­ tices is distressingly low, and avoidable medical errors are widespread.14 delivery systems matter. it is increasingly understood by patient safety experts that institutional practices drive error rates more than individual fail­ ings, ts and by medical quality experts that care coordination is essential to suc­ cessful health outcomes. so does patient involvement. patient-centeredness has become a core characteristic of good medical care, 16 with many commenta­ tors emphasizing the importance of reliable information about the cost and quality ofhealth care services and providers. moreover, physicians' propensity to generate complaints seems to be a marker for clinically significant quality lapses in hospitals.17 and while few would defend the medical malpractice sys­ tem as a cost-effective method of either compensation or quality improvement, it has become clear from empirical research that unprevented, uncompensated injuries are a more troubling problem that frivolous lawsuits.18 a major problem hoffinan and rowthom identify is medicare's long­ standing preoccupation with protecting the reputation of individual physicians by assuring strict confidentiality during, and even after, complaint review. 19 in an era increasingly (and properly) concerned about keeping patients' personal health information private and secure from others, denying beneficiaries infor­ mation about the disposition of their own complaints seems bizarre unless one understands its history. as hoffman and rowthom note, recent reforms pro14. see world health oro., 1he world health rep. 2000, health systems: improving performance (2000), available at http://www.who.int/entity/whr/2000/en/wbr oo_en.pdf(last visited may 5, 2008); org. econ. & cultural dev., health care quality in­ dicators project, http:/ /www.oecd.org/documentprint/0,3455,en _ 2649 _ 34631_2484127 _1_1 _1_1,00.html (last visited may 5, 2008); karen davis et al., 1he commonwealth fund, mirror, mirror on thew all.: looking at the qualtiy of american health care through the patient's lens (2004). 15. insr. of med., to err is human: building a safer health system (1999). 16. inst.ofmed.,crossingthequaltiyc8asm:anewhealthsystemforthe21st century (2001). 17. gerald b. hickson et al., patient complaints and malpractice risk 287 jama 2951, . 2951 (2002). 18. david m. studdert et al., claims, e"ors, and compensation payments in medical malpractice litigation, 354 n. eng. j. med. 2024, 2024 (2006). 19. hoffmann & rowthom, supra note 1, at 12. 2008] dances with elephants 5 posed by cms seem half-hearted, as much concerned with restricting access to information by malpractice lawyers as with liberalizing information access for beneficiaries.20 they report, for example, that qios systematically exclude from mediation any case involving actual quality of care problems, even though cms introduced mediation in 2003 to provide a less constrained environment than case review for resolving beneficiaries' complaints.21 concealing provider error from affected patients runs counter to current thinking among patient safety experts about the transparency of adverse events,22 and to emerging professional norms regarding candor.23 although early formulations of the patient safety problem recommended shielding profes­ sional process reengineering from external scrutiny in order to promote event reporting and frank analysis, excruciatingly slow progress has convinced both individual pioneers in the field (e.g., donald berwick, lucian leape) and lead­ ing quality improvement organizations (e.g., the joint commission, the institute ofmedicine) that errors causing harm should be openly acknowledged and rea­ sonable compensation for injury promptly offered. 24 early mediation is increas­ ingly recognized as an effective vehicle for these conversations.z5 a related problem with the qio process is that few corrective actions are taken against providers even when complaints are found to be valid. the qio process is disconnected from other carrots and sticks medicare possesses to promote quality, such as payment policy. nor do qios share information with other regulatory bodies that have greater enforcement capabilities with respect to physicians or hospitals, notwithstanding their supposedly similar consumer protection missions. consequently, "accountability" through qio review offers 20. id. at 17. 21. id. at 15. 22. see joint comm'n on the accreditation of healrncare organizations, seti1ng the standard: the joint commission and healmcare safety and qualtiy 12 (2005), available at http://www .jcaho.orglaccredited+organizations/patient+safety/setting_ the_ standard. pdf (on file with the authors). see generally inst. of med., crossing tile qualtiy chasm: a new realm system for the 21st century (2001); lnst. of med., to err is human: building a safer healtii system (1999). 23. editorial, medical error and ethics: a call for candor without fear, 46 am. med. news 14, (july 21, 2005), available at http://www.ama-assn.org/amednews/2003/07/21/eds a0721.htm (last visited may 3, 2008). 24. robert galvan, "a deficiency of will and ambition": a conversation with donald berwick, 10 realm a.ff. w5-1, w5-l (jan. 12, 2005), http://content.healthaffairs.org/cgi/re printlhlthaff.w5.1v2.pdf(last visited may 5, 2008); lucian l. leape,fulldisc/osureandapol~ ogy: an idea whose time has come, physician executive (mar.-apr. 2006), http://findart icles.com/p/articles/mi_m0843/is_2_32/ai_nl6123939/pg_3 (last visited may 5, 2008); inst. of med., fostering rapid advances in healrncare: learning from system demonstrations (2002);jointcomm'nonaccreditationofhealti1care0rganizations,healtiicareat me crossroads: strategies for improving me medical liability system and preventing patient injury 12 (2005), http://www .jcaho.org/news+room/press+kits!tort+reform/medical_ liability_ exec_ sumrnary.pdf (on file with the authors). 25. carol b. liebman & chris stern hyman, a mediation skills model to manage disclo­ sure of errors and adverse events to patients, 23 healrnaff. 22,22 (2004). 6 indiana health law review [vol. 5:1 little opportunity to assess problems with the institutional processes by which care is delivered. the only exception to this pattern was the development in the 1990s of a parallel set of procedures for handling complaints involving medi­ care managed care, 26 but even those changes reflected a general desire to main­ tain beneficiary trust in an unfamiliar administrative environment rather than specific concern with the quality of reconfigured medical care. ill. reinventing complaint review as administrative compensation for injury a radical reinvention of medicare's beneficiary complaint review process would give qios both the authority and the responsibility not only to review complaints, but also to provide beneficiaries with complete information and appropriate compensation for medical injury. conventional malpractice litiga­ tion serves medicare beneficiaries poorly, with aged or previously disabled in­ dividuals being far less likely than other negligently injured patients to obtain compensation through the courts.27 the medicare program has shaped national health policy and molded the politics of health care since the 1960s, but (as hoffmann and rowthom 's article illustrates) has walled itself off from liability determinations in part for fear of alienating physicians. bringing injury com­ pensation for beneficiaries within medicare's scope therefore could have a salu­ tary effect on the malpractice system as well as on the weak system of complaint review that medicare currently supports. in previous scholarship,28 we argued that the medicare program has the requisite infrastructure in place today to adjudicate the medical malpractice claims of medicare beneficiaries. that infrastructure at present includes the qios and their medicare beneficiary complaint function,2 as well as the griev­ ance and administrative review functions available for disputes about medicare coverage and other disputes that medicare beneficiaries have with the medicare program. 30 information derived from the detection and disclosure of adverse events by qios in connection with the disposition of medical injury claims would feed into the overall qio process and other quality-oriented medicare 26. eleanor d. kinney, protecting american healtii care consumers 136-38 (2002). 27. see gov't accountability office, leaflet no. ga0-93-126, medical malpractice: medicarfimedicaid beneficiaries account for a relatively small percentage of malpractice losses 2-3 (1993). 28. see william m. sage & eleanor d. kinney, a malpractice system for medicare, in medical malpractice reform in tile united states: newcen'rory,differentissues(wil­ liam m. sage & rogan kersh eds. 2006); eleanor d. kinney & william m. sage, resolving medical malpractice claims in the medicare program: can it be done?, 12 conn. ins. l.j. 77' 77 (2005-2006). 29. jd. at 88-92. 30. jd. at 92-97. 2008] dances with elephants 7 initiatives. over time, this comprehensive data resource would facilitate greater understanding about the epidemiology of medical injuries.31 we have specified in detail elsewhere how the medicare quality assurance infrastructure might be modified in a formal demonstration project that would adjudicate medical injury claims for providers and beneficiaries who elected to participate. we suggested offering federal stop-loss protection and other incen­ tives to providers with the structural capacity to monitor and improve quality and safety. 32 this condition would focus the demonstration on hospitals, mul­ tispecialty physician practices, and similar models of health care delivery that have developed organized systems for identifying, redressing, and preventing unanticipated outcomes of care. for beneficiaries, we emphasized speed, ease, and fairness of the adjudication and compensation process as enticements to participate. 33 iv. the need for ••disruptive regulation" in medicare it is currently fashionable to describe bottom-up changes in the market­ place that challenge and eventually overturn longstanding top-down structures as "disruptive innovations."34 public programs ofmedicare's scale and scope may require an analogous process of "disruptive regulation" at key contact points between the government and its citizens to dislodge entrenched but fun­ damentally misguided biases that diminish those programs' effectiveness. a demonstration program that charged the qio process with hearing and resolving cases of patient injury, with mediated discussions, reasonable awards of compensation, and feedback to participating institutional providers regarding the safety and quality of their care could productively disrupt current practices in both medicare and conventional malpractice litigation. put differently, test­ ing the qio process on cases of real medical injury would move the elephant off the dance floor, leaving room for collaborative quality improvement. clos­ ing the loop between patient experience and system response would change the beneficiary complaint process from one that is relatively impotent to one that produced real results for medicare beneficiaries while enabling providers to identify, rectify, and learn from medical errors in an expeditious fashion. 31. /d. at 107. 32. /d. at 99-103. 33. /d. at 103-04. 34. see christensen, clayton m., bohmer, richard, & john kenagy, will disruptive in­ novations cure health care?, 78 harv. bus. rev. 102, 102 (sept. 2000). see also clayton m. christensen, the innovator's dilemma, harv. bus. sch. press. (1997); bower, joseph l. & christensen, clayton m., disruptive technologies: catching the wave, 73 harv. bus. rev. 43 (jan.-feb. 1995). david e. kelleher david e. kelleher was one of the founders of indiana's first managed care organization, a prepaid group practice in central indiana. he served as its executive vice president from 1973 to 1986. he then founded healthcare options, inc. ("hoi") in 1986 and is its president. hoi has developed and managed hmos and ppos, provided turnaround services for managed care companies and provided consulting services to health plans, medical groups, hospitals and employers in thirty-eight states. healthcare options, inc. participated in founding the employers forum of indiana and mr. kelleher serves as the executive director of this multi-stakeholder health care organization. hoi is also a consultant to the employers health forum of lafayette/west lafayette. mr. kelleher holds a master of science (economics) from butler university and a bachelor's degree from indiana university. j. mare overhage j. marc overhage, m.d., ph.d., is president and ceo of the indiana health information exchange ("nne"), senior scientist at the regenstrieflnstitute, inc. and professor of medicine in the department of medicine at the indiana university school of medicine. dr. overhage is author of almost one hundred papers in the scientific literature, has contributed to several books and is a sought after speaker for national and international meetings. his research has focused on supporting clinical decisions with information and clinical knowledge. over the last eighteen months with nne, dr. overhage has led the deployment of the nation's first sustainable health information exchange and is overseeing the operational launch of a community wide clinical quality initiative which has been developed in collaboration with leading payors, provider groups and employers. dr. overhage is a fellow of the american college ofmedicallnformatics and the american college of physicians and serves on the editorial board of the journal of the american medical informatics association. he serves as the chair or member of numerous national leadership groups including connecting for health and connecting communities for better health. dr. overhage holds a b.a. from wabash college and a m.d. and ph.d. from the indiana university school of medicine. pay -for-performance in central indiana david e. kelleher· j. marc overhage .. intr.oducfion evidence continues to show that healthcare providers deliver care inconsistently.1 this has led many payers, including hmos, commercial carriers and medicare to advocate a strategy which better aligns the incentives of providers with the payers by paying providers explicitly for quality improvement. in this essay, we discuss the status of a novel community-wide pay-for-performance ("p4p") program in central indiana. the program has achieved broad support from a coalition of employers, health plans, physicians, hospitals and public health officials and much of its architecture is now clear. this article reviews the coalition's conception, development of the program and the unresolved issues remaining to be addressed. although the indiana health information exchange ("ihie'') will manage much of the future p4p activity, this initiative grew out of the employers' forum of indiana ("forum"). thus, a brief history of that organization is necessary. i. brief history of the forum the employers' forum of indiana, formed in late 2001 by a small number of large employers as a "forum" in which to discuss common strategies to improve the value of health care expenditures received by employers and their employees, took a rather circuitous route to the p4p program.2 during 2002, the forum expanded its non-health employer membership and, in september, invited local hospitals to participate as members. in june of2003, the forum formally invited health plans, physician groups, physician-hospital organizations ("phos") and other organizations to • president, healthcare options, inc., and executive director of the employers forum of indiana; master of science (economics) butler university. ** president and ceo, indiana health information exchange; m.d. and ph.d. (biophysics), indiana university. i. this variation has been widely documented by dr. john e. wennberg and his colleagues at the dartmouth medical school. for a recent study, see john e. wennberg, variation in useofmedicareservicesamong regions and selected academic .medical centers: is more better?, commonwealth fund pub. no. 874 (dec. 2005). 2. initial organizers included dr. gregory larkin of eli lilly and company, russ towneroidaimlerchryslerandjamesmillsofgeneralmotorsalongwithhealthcareoptions, inc., a health care consulting fum. these firms were soon joined by indiana university, cinergy, the city oflndiaruipolis and marion county, indiana state personnel, marsh supermarkets, ivy tech and meijer. 376 indiana health law review [vol. 3:371 join. 3 this expansion was vital as it broadened the discussion to include diverse perspectives and allowed the forum to develop a process whereby all significant stakeholders participated in defining forum initiatives. initial forum meetings concentrated on understanding how the health care market functioned and why it was not performing to the satisfaction of its participants. for example, forum members reviewed and discussed selected works by alain enthoven\ john wennbergs and the institute of medicine's report, crossing the quality chasm.6 these discussions led to a set of principles supporting the goal of value improvement from which common initiatives would be developed. these principles include the following: • inclusion and transparency: the forum includes employers, providers, health plans, public officials and others invited to achieve the forum's goal. meeting minutes are posted on the forum's web site.7 • measurement and reward: the forum will seek to fairly measure provider performance and reward providers who deliver superior value. • consumer involvement: where possible, the forum will promote programs wherein the employee can become a consumer, armed with the information and incentives necessary to act in this capacity.· • incentive alignment: the forum seeks to improve the "business case" for provider investments in value improvement activities and programs, specifically including health information technology. ll. formation of tim quality commi'itee one of the first initiatives undertaken by the forum was an attempt to change the way employers purchased coverage from hmos. the forum asked the hmos to do three things: 1. begin to measure patient acuity for each physician-hospital organization ("pho") and adjust payments to these organizations 3. other organizations included the indiana state department of health, health care excel, representatives of the state medicaid authority and ihie. 4. see alain c. enthoven. why managed care hm failed to contain health costs, 12(3) healmaff. 27,27-43 (1993). 5. see john e. wennberg et al., geography and the debate over medicare reform, healtiiaff. suppl web exclusive, w96-w114, (2004). 6. seeinst.ofmi!d.,crossingtiiequauiychasm:anewhealtiisystemfortiie 21st century (2001). 7. health care options, inc., at http://www.boi.comlhoiflforum&hoiwebsite= 6ab116d6a06799eb305ed8a1f7e4806c (last visited feb. 27, 2006). 2006] pay -for-performance in central indiana 377 to reflect differences in health status. at that time, both provider­ owned hmos (m plan8 and advantage9) required members to choose a single pho for all of their care. the health plans transferred fmancial risk to the phos by paying them a capitation (either dollar-denominated or percentage of their premium) for essentially all services, regardless of utilization, cost or patient health status. the forum believed this payment mechanism was potentially unfair to providers and would prevent value-based competition among phos. 2. measure the quality of care each pho delivered and provide this information to prospective members at the time of enrollment. the purpose was to arm the patient/employee with information necessary to make an informed choice in selecting his or her provider. 3. provide differential premiums by pho rather than a common premium for all. in combination with the above, the intention was to stimulate value-based competition among the delivery systems (phos) within the hmos. at the suggestion ofthe hmos, the forum assembled a committee to investigate acuity measurement systems. a high priority was to promote physician involvement so the resulting committee was "provider-heavy," even though it included health plans and employers. after a year's effort, all parties concurred on the selection of an acuity measurement system which was later adopted by both hmos. 10 this committee, now called the quality committee, turned its attention to selecting quality measures for the second part of this initiative. as it did so, the committee's membership expanded to include the state health commissioner, representatives of the state medicaid authority ("fssa"), health care excel (the quality improvement organization or "qio" serving indiana and kentuck:y)11 and eventually, the indiana health information exchange. 8. m plan is a provider-owned health plan, providing health care coverage to more than 160,000 people in northern and central indiana. m plan, at http://www.mplan.com (last visited feb. 20, 2006). 9. advantage health solutions, inc. is a statewide managed care plan. it is owned by four catholic health care systems: ancilla systems, a$cension health, sisters ofst francis of perpetual adoration and saint joseph regional medical center. advantage health solutions, inc., at http://www.advantageplan.com (last visited feb. 20, 2006). 10. the system selected was dxcg, the commercial version of the predictive modeling system chosen by cms to risk-adjust payments to medicare advantage hmos, available at http://www.dxcg.com (last visited feb. 27, 2006). 11. inearly2003, dr. larkin, theforum'schainnan, arranged a meeting with the health commissioner, dr. gregory wilson, to determine how the private and public sectors might work in concert to promote value improvement. this led to the very active participation ofisdh, medicaid ("fssa ")and health care excel on the forum's quality committee. 378 indiana healm law review [vol. 3:371 the quality committee and the hmos agreed upon a set of quality metrics and the first pro-specific quality reports became available in late 2004 (and were issued again in late 2005). the third leg of the initiative, differential premiums by pho, failed to materialize due to provider resistance.12 the expansion of the committee, however, broadened its focus and led directly to the p4p initiative, which is described after discussing the formation oflliie. ill. the rise of indiana health information exchange in february 2004, lliie was formed by merging the efforts of three separate community endeavors: icareconnect, the indiana network for patient care and biocrossroad's evidence-based medicine initiative. icareconnect evolved out of a "grass roots" community physician initiative that focused on the need for an electronic infrastructure to connect the region's healthcare community. it created a plan for deploying clinical messaging13 throughout the market and was seeking a technology partner and funding. the indiana network for patient care (''inpc'') was created by the regenstrieflnstitute, inc. ("ri'') which is a non-profit medical research organization that pioneered clinical information technology and clinical information standards. the inpc captures clinical data from numerous sources and provides for secure electronic exchange to make the information available to providers at the point of care as well as for other purposes. finally, biocrossroads identified evidence-based medicine as a focus area during a strategic planning process designed to uncover central indiana's sectors of greatest opportunity in the life sciences. their plan provides a unified vision for various regional efforts. lliie is a non-profit organization that supports the communal efforts of thirteen organizations representing hospitals, physicians, researchers, public health organizations, citizens in the community and economic development groups. its purpose is to improve the quality, safety, efficiency and efficacy of health care in indiana; create research capabilities for health services researchers; and establish a successful model ofhealth information exchange for the rest of the country. ihie is creating a common, secure, electronic infrastructure that expands communication and information sharing among physicians, hospitals, public health organizations and other health care entities. an important goal is to offer pr<>viders better information at the point-of-care for treatment purposes. ihie is creating sustainable business models and providing implementation, support and process that surround the health information infrastructure created by the regenstrieflnstitute. ihie's clinical messaging service provides secure electronic results deliveries from 12. a number of the phos decided not to participate in a product that contained tiered premiums. 13. clinical messaging is the secure electronic delivery of clinical infonnation from sources such as laboratories and radiology centers to the patient's physicians. 2006] pay -for-performance in central indiana 379 hospitals, laboratories, public health agencies and radiology centers to providers improving the quality and efficiency of care. oocs4docs®, the clinical messaging software developed by dr. mi~hael barnes of the regenstrief institute, now delivers approximately 30,000 clinical results to over 3,000 physicians each day. for the pay for performance program, nile will combine clinical observations from laboratories, radiology centers, hospitals and other providers with clinical data from physician offices and claims data from payers to create a robust view of clinical care. iv. the development of the pay for performance program during the latter half of 2003 and early 2004, the forum's quality committee engaged in a wide ranging discussion of how to improve the business case for provider adoption of technologies which hold the promise of improving patient care, such as registries or electronic medical records, especially for patients with chronic illnesses. at that time, the state (isdh and fssa with health care excel) was promoting the adoption of a chronic care registry for medicaidandmedicarepatients, but having difficulty gaining physician support for its implementation, even though the system would be provided without charge. after several meetings with participating medical groups where the registry system was reviewed, it was learned that physicians resisted implementation because it required double entry of informa~ion, which was both expensive and intrusive to work flow and because the potential rewards for implementation (from the medicaid program. alone) were relatively small. the discussions also revealed these issues, which included extra effort with rewards confined to a small proportion of the patient population, applied to other programs such as the bridges to excellence ("bte") program. in fact, only one medical group in central indiana participated in the bte program and it did so despite the additional expense and lack of economic returns. 14 this led the committee to review what other communities were doing in this arena. it reviewed the programs of independent health in buffalo, the bte program, the developing multi-hmo program in california (integrated healthcare association) and others. for various reasons, none of these programs were entirely suited to the situation in central indiana. the committee concluded that, in addition to its other goals, a successful program. needed to address the following issues that confounded the state in its promotion of chronic care registries: • any reporting system must be minimajjy intrusive at the practice level; and 14. methodistmedicalgroup,athtlp:/lwww.methodistmedicalgroup.org(lastvisitedfeb. 20, 2006). 380 indiana health law review [vol. 3:371 • any incentives must apply to enough patients to be meaningful to physicians. subsequent discussion focused on how to collect information in a minimally intrusive fashion. it began with the question of what information would be valuable and how then to collect important clinical values. 15 as the committee explored options for capturing clinical values, it discovered ihie, which was already making electronic connections with hospital-based and large independent reference laboratories. the idea emerged that ihie, with the support of regenstrief institute, might also collect claims information, match this information with clinical values and provide valuable information to individual physicians. in august of2004, the quality committee formally proposed an alliance with ihie to develop a community-wide quality reporting system, supported by a multi-payer pay-for-performance system.16 this produced the first crude schematic of the program (diagram 1). diagram 1 15. during the spring of2004, the quality committee developed a list ofinformation that would be valuable to practicing physicians, which included a small number ofhigb priority lab values (inr, hbai c, microalbumin, lipid profiles, triglycerides, and creatinine). using their hmo claims data, each pho produced a list of where these tests were preformed with the intention that, working with ihie, we could find a way to collect this information. 16. the committee at that time included: dr. gregory larkin (lilly and forum chairman), dr. gregory wilson (health commissioner), dr. lee campbell (sho), dr. dick need (st. francis), dr. john ellis (m plan), dr. chuck stemple (united healthcare), dr. tim hobbs (community physicians), dr. tom diller (mmg), dr. randy howard (anthem), dr. john fitzgerald (iumg), dr. isaac myers (advantage), dr. joe fox (m plan), mickytripathy, ph.d. and dr. j. marc overbage (ihie}, james mills (gm}, russ towner (daimlerchrysler), tina hayes (cinergy), phil morphew (hce), melanie bella (fssa) and david kelleher and dick scbnute (healthcare options). 2006] pay -for-performance in central indiana 381 iiue emerged as the trusted intermediary with the skills and structure necessary for this community-wide program. it earned part of this trust through participation on the quality committee, but more so by virtue of its structure, goals and its focus on providing actionable information to providers. the quality committee then turned its attention to developing initial quality measures. it started by recognizing that collecting the information needed for the reports had to be minimally intrusive to physician practices and the data had to be readily available or easily and affordably assembled. the committee interpreted these two requirements to mean that data for any quality metric should be available from health plan claims or administrative data or amenable to electronic capture by iiue (e.g., laboratory values). in addition, it was concluded that the selected measures should have: • a clear and compelling evidence-based link between the process measured and their outcomes. • national standing, i.e., preference for measures that are endorsed and used by reputable organizations of national standing such as: the health plan employer data information set ("hedis"), the national quality forum ('"nqf"), medicare's doctor office quality ("doq-it") program17, or the bridges to excellence ("bte") program. • interest to physicians, providing information that they consider important but are not likely to possess. the committee also decided on a stepwise development, starting with primary care physicians, then specialists and, finally, hospitals. over the next nine months, it reviewed the measures used in many other programs and selected a "starter set" of thirty initial measures (exhibit 1 ). the committee then approved an overview of the program, outlining its expectations of the program's operation, information handling and participant roles. v. wheretheprogramstandstoday as manager of the program, ihie will: o collect membership and primary care provider information, medical and pharmacy claims data from each participating health plan. 17. the doq-it program is a national initiative that promotes the adoption ofelectronic health record ("ehr'') systems to improve quality and safety for medicare beneficiaries in smalland medium-sized physician offices. cms expects data from ehrs to enable them to measure quality improvement 382 indiana heal1h law review [vol. 3:371 o collect relevant clinical data from reference laboratories, imaging centers, hospitals and from physician offices and inatch these data to individual patients. o for programs wherein a covered member does not formally select a pcp, ihie will, when feasible, algorithmically assign a relationship between each patient and a physician. o produce reports or databases for health plans and physicians using metricsand definitions approved by the participating health plans, providers and employers summarizing providers' performance, including individual patient level reminders and securely deliver these reports to providers. o collect incentive payment information from the health plans and provide quarterly reports to each physician or physician group summarizing the incentives paid under the p4p initiative. the estimated program costs are $3-4 million in developmental funds and about $2 million per year to operate, which will depend only minimally upon the number of participating plans, physicians and patients. ihie is in the process of raising the developmental funds through foundation support. operations will be funded by the participating health plans with each plan paying a pro-rata share oflliie's costs based upon membership (with respect to the provider-owned hmos, funding will be shared between the hmos and· their capitated phos). two committees will provide guidance for the p4p program. nile will form a program administrative committee, which is analogous to the clinical messaging steering committee that ihie created to guide the clinical messaging project this committee will represent the interests of participating health plans and employers. it will be composed of participating health plans, selected employers and at least one physician from the measures committee, formerly called the quality committee, and its function will include: o reviewing lliie's program budget and allocate participation fees among the health plans; o establishing rules for participation by all parties, including issues such as incentive compensation parity and reporting; and o evaluating lliie's performance. · the second committee, the forum's measures committee, will be populated, much as it is today, by the medical directors of the large participating medical groups, phos and health plans. its charge is: o to develop or approve new measures as the program matures. o to recommend to the administrative committee how payers should use measures in compensation arrangements in order to achieve improvements in or maintain high levels of quality. 2006] pay -for-performance in central indiana 383 o to ensure fairness in reporting, for example: > when and how to use demographic adjustments in quality reporting. > how non-compliant patients are factored into metrics (and how their metrics interact with incentive compensation). o to determine when to make physician level quality information available to employers and patients. the intention is to ensure that that the information is a~yurate and that physicians have an opportunity to improve resillts before the information becomes more widely distributed. participating health plans (and phos) will receive: o a quality report for each of its own members with full detail (i.e., the plan will be able to identify each patient and each physician and the metrics for each patient). o a summary quality report, by physician, across all patients from all participating health plans, with a breakdown for commercial, medicaid and medicare patients. however, these reports will not include patient identification or patient-level detail. summary reports are intended to serve as the basis for p4p payments and to allow the plan to produce comparative reports (the plan's patients vs. total) for internal quality improvement activities and as information for employers. o a quarterly summary of the ·incentive payments made to participating physicians by all participating plans. in addition to funding operations, health plans will be required to develop an incentive system, if one is not currently in place, and base a "meaningful portion," defined by the administrative committee, of its relevant provider incentive payments on the common quality measures. the purpose is to concentrate physician attention on improving the quality measures selected by the measures committee. vi. significant remaining issues and process a number of important processes and issues remain under development. these include: a. obtaining binding commitments to participate the committee is now developing "term sheets" for signature by each potential participant-health plan, pho and physician. these documents will include contingencies and will detail what the community expects of each party, reflecting the program overview approved by the forum's quality 384 indiana iieal1ll law review [vol. 3:371 committee. for example, program costs and benefits depend upon the number of patients involved. term sheets will specify a health plan's commitment to participate will not commence until we have commitments from health plans covering a minimum of 500,000 patients. because· anthem has already committed, this threshold should be obtainable. b. performance incentives after we obtain sufficiently broad participation, we will convene the administrative committee. one of the committee's first tasks is to address the issue of performance incentives. we expect that each participating plan will develop its own performance incentive system. it is unlikely that all plans will be able to adopt the same methods (e.g., periodic bonuses, capitation payments, different fee schedules, etc.) or incentive amounts, especially since the endeavor includes both self-funded and insured commercial members as well as those eligible for medicare and medicaid. while the forum believes it has selected and will continue to select measures that have a potentially high return on investment, each health plan must justify its own incentive payments to the end payer and each plan may establish its own incentive payment­ related weighting system for the common measures. in order for the overall program to succeed, however, we expect incen­ tive payments to be roughly comparable across plans. the administrative committee is responsible for ensuring this equivalence. when incentive payments from all plans are considered, it is the forum's intention that incentives for the highest performers will add materially to their incomes. for instance, evidence suggests total incentives of $10,000 to $20,000 per physician are required to fully engage physicians, recognizing that providers will invest a portion of these incentives to reach the quality goals.18 in addition, this committee will address the issue of the distribution of incentives between high performance and improving performance. for example, a recent article concluded, "[p]aying clinicians to reach a common, fixed performance· target may produce little gain in quality for the money spent and will largely reward those with higher performance at baseline. "19 during the.first year, as information is being developed and verified, incentive payments may include physician participation components evidenced by providing laboratory results and other information from their practices and using the reports to improve patient care. 18. for a discussion of the importance of combining incentives across payers to achieve meaningful rewards levels, see arnold m. epstein et al., paying physicians for high-quality care, 350 new eng. j. med. 406, 406-10 (2004). 19. meredith b. rosenthal et al., eorly experience with pay-for-performance: from concept to practice, 294 jama 1788, 1788 (2005). 2006] pay -for-performance in central indiana 385 c. measurement issues the measures committee may develop a weighting system so that we can provide physicians with a peer comparison of performance across measures. the committee will also continue to develop additional measures, including measures of efficiency, in order to focus physician attention on the cost side of the value improvement equation. d. medicare the intention is to include medicare in this program and seek cms 's approval as a demonstration program. one such opportunity is to respond to the rfp issued under the authority of the medicare modernization act, section 646.20 e. expansion finally, the issue of geographic expansion must be addressed. in response to a request by the employers health forum of lafayette!w est lafayette, indiana, we are committed to expanding the program to that community in 2006. in addition, other requests to expand to other parts of indiana and ohio have been received. this suggests the need for a developmental plan that ensures the program does not become over-extended. conclusion as we noted earlier, we were unable to find a program elsewhere that serves the needs of our community. the integrated healthcare association ("iha") in california provides a working example of what can be done, but its hmo focus will not work in indiana. in our judgment, a successful pay­ for-performance program needs to address two imperatives. first, reports to providers must contain evidence-based measures that providers support and cover a significant proportion of the provider's patient population if providers are to use them to improve care. second, incentives must be large enough to provide a meaningful impetus to quality improvement. for the indiana community, this means that the program must cover insured and self-funded commercial populations, span the managed care spectrum from tp a to insurer to hmo (and, in indianapolis) to pho and include medicare and medicaid patients. this also suggests that an inclusive process-one whereby all stakeholders participate in a manner that is acceptable to them-is important. if we also recognize that our current ability to measure performance is 20. medicare modernization act (mma). pub. l. no. l 08-173, 117 stat. 2066 et. seq. (2003) (codified in scattered sections of26 u.s.c.). 386 indiana health law review [vol. 3:371 imperfect, the most durable feature of the program may, in fact, be its inclusive structure. over this lengthy developmental period, the overarching purpose of the program has remained the same. its purpose is to improve value from the perspective of the patient and the payer, i.e., to improve the quality and con­ sistency of care while reducing its cost. this program will not immediately accomplish this goal. employers, however, view it as an important first step toward re-aligning the financial interests of the provider community with those of the patient and payer. the hope for the future is that this re­ alignment will improve the business case for the provider adoption of the technology, organizational forms and programs that are necessary to achieve lasting and continuous value improvement. the p4p program would not have been possible without the concurrent development of the employers forum of indiana and ihie, organizations that share a commitment to improving quality on a community wide basis. it also would not have been possible without strong community-focused leadership21 and the active participation and support of the community's largest health insurer-anthem blue cross and blue shield. 21. many people contributed to the forum's agenda. five deserve special mention for their leadership, enthusiasm and generous donation oftime and ideas-the forum's chair, dr. gregory larkin of lilly, the former state health commissioner dr. gregory wilson, dr. tim hobbs of community physicians oflndiana, dr. david lee of anthem and mr. russetl towner ofdaimlerchrysler and gm. 2006] pay-for-performance in central indiana 387 exhibit 1 -performance measures .,hysieian name: deseription of measures ..... hudren appropriate strep testing the percentage of children 2-18 years of age. who were diagnosecl with pharyngitis. prescribed an antibiotic and received a group a streptococcus (strep) test for the episode. this measure assesses the adequacy of clinical management of pharyngitis episodes for members who received .an antibiotic prescription. appropriate treatment the percentage of children 3. months-18 years of age who were uri given a diagnosis of upper respiratory infection (uri) and were not dispensed an antibiotic prescription on or three days after the episode date. this process measure assesses whether antibiotics were · ately prescribed for children with uri. ~omen's health breast cancer screening the percentage of women 50-69 years of age who had a mammogram during the measurement year or year prior to the measurement year. cervical cancer the percentage of women 1~ years of age who received one or screening more pap tests during the measlirement year or the two years prior to the measurement year. chlamydia screening the percentage of women 1~25 years of age who were identified as sexually active and who had at least one test for chlamydia during the measurement year. age 16 to 20 • 1 ~20 year-old women age 21 to 25 • 21-25 year-old women overall rate • overall rate. diabetes hbalc testing the percentage of members 18-75 years ofage with diabetes (type 1 and type 2) who received an hbalc test poor hba1c control (>9) the of patients with levels of poor control lipid profile the percentage of patients 18-75 years of age with diabetes (type 1 and teyp 2) who receive an ldl-c · test lipid control ldl < 130 %of above where ldl-c <130 lipid control ldl < 100 %of above where ldl-c <100 monitoring diabetic this measure is intended to assess if diabetic patients are being nephropathy monitored for nephropathy: members who have been screened for microalbuminuria, or members who have nephropathy, as demonstrated by either evidence of medical attention for nephropathy, visit to nephrologist or a positive macroalbuminuria test (not included for trace · 388 indiana health law review [vol. 3:371 asthmaappropriate the percentage of enrolled members 5-56 years o( age during the medications measurement year who were identified as having persistent asthma during !he year prior to the measurement year and who were • prescribed medication during the measurement year. age5to9 pen:entage by age category age10tol7 pen:entage by age category age 18to56 percentage by age category combined the combined rate will be the sum of the three numerators divided by the sum of the three denominators. beta to steroid ratio definition under development alltldepressioll medieatlon management optimal practitioner the pen:entage of members 18 years of age and older as of the contacts for medication 120th day of the measurement year who were diagnosed with a new management episode of depression and treated with antidepressant medication, and who had at least three follow-up contacts with a non-mentalhealth practitioner or mental health practitioner coded with a mental health diagnosis during the 84-day (12-week) acute treatment phase. at least one of the three follow-up contacts must be with a pfescrlbingpractitioner( e.g., licensed physician, physician assistant or other practitioner with prescribing privileges). this process measure assesses the adequacy of clinical m8nagement of new treatment episodes for adult members with a major depressive disorder. effective acute phase the percentage of members 18 years of age and older as of the treatment i 20th day of the measurement year who were diagnosed with a new episode of depression and treated with antidepressant medication, · and who remained on an antidepressant drug during the entire 84day(l2-week) acute treatment phase. this intermediate-outcome measure assesses the percentage of adult members initiated on an antidepressant drug who received a continuous trial of medication treatment during the acute treatment phase. effective continuation the pen:entage of members 18 years of age and older as of the phase treatment 120th day of the measurement year who were diagnosed with a new episode of depression and treated with antidepressant medication, and who remained on an antidepressant drug for at least 180 days (6 ·months). this intermediate-outcome measure assesses the effectiveness of clinical management in achieving medication compliance and the likely effectiveness of the established dosage regimen by determining if adult members completed a period of continuation phase treatment adequate for defining a reeovery, according to agency for healthcare research and quality (ahrq, formerlv -a hrpr\, -deoression in primarvcare. 2006] pay-for-performance in central indiana 389 cardlovaseuhlr redia cholesterol mngt after the percentage of members 18-75 years of age as ofdecember 31 acute cvevent of the measurement year who were discharged alive in the year prior to the measurement year for acute myocardial infarction (ami), c01'()il8l')' artery bypass graft (cabo) or percutaneous transluminal coronary angioplasty (ptca) and who had each of the following between 60 and 365 days after . : screening (lipids) ldl-c tested control < 130 ldl-c < 130 mgldl control < 100 ldl-c < 100 mgldl otbercllnleaimeuures colorectal cancer the percentage of adults 56-80 years of age who had appropriate screening screening for colorectal cancer (crc). the hybrid method is recommended to calculate this measure. · hospital readmissions readmission rate for patients within 30 days of an admission for the samedx same diagnostic category as the admission. metric not fully specifiedftom pacifi~ rather than hedis optimal op care to lltfedical experts agree that for certain chronic conditions, hospital a void hospitalization admissions can sometimes be prevented with optimal outpatient care. this measure reflects the percentage of all hospital admissions for these select conditions. example is asthma. measure not fully specified. imaging for low back pain this measure assesses whether imaging studies (plain x-ray, mri, ct scan) are overused in evaluating patients with acute low back oain. indiana health law review volume6 2009 articles altered standards of care for health care providers in the pandemic influenza paging king solomon: towards allowing organ donation from anencephalic infants notes an athlete's right to privacy regarding sport-related injuries: hippa and the creation of the mysterious injury laryngoscopes, lidocaine, and liability: the absence of immunity protection for prehospital providers in indiana unfair and harsh results of contributory negligence lives in indiana: the indiana medical malpractice system and the indiana comparative fault act health should not be a determinative factor of whether one will be a suitable adoptive parent issue 1 1?/eanorl>.jrinn~ heather a. mccabe amy lewis gilbert janna jo shisler fazal jrhan brian lea james blake hike meghan a. cox bruce 1>. jones brenda jr. devries indiana university school of law indianapolis iupui indiana ileal th law review volume6 editor-in-chief andrew j. vanlandingham executive m11nt1ging editor jennifer strange executive prodllction editors shelley hallberg j. blake hike executive biisiness editor paige boggs executive notes editor bruce jones executive articles editors ravi deol jackie landess 2009 note development editors articles editors associate editors joe bruno amanda quick matt mccoy ann speidel sarah steinhardt mary beth arnold christopher l. arrington ashley arthur beth a. barnes adam n. bolerjack brian bouggy lauren devich stephen donham rachel hebner caleb kacarab susan kindig, md matt lasher meghancox brian dunkel liz currid jennifer m. triplett adam dolce heidi reed members ft~cully advisors lawrence p. wilkins (chair) david orentlicher (chair) eleanor d. kinney robert a. katz emily morris brenda k. devries allison matters john mclaughlin marc menkveld barbara molargik anna m. ly-pham emilee s. preble melissa reynolds hilari a. sautbine marc steams trampas a. whalin shena wheeler contessa wilson indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics ofhealth law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2006-07 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university school ofl.aw -indianapolis. subscriptions. the current subscription rate is $20.00 for two issues (domestic mailing). unless the business office receives notice to the contrary, all subscriptions will be renewed automatically. claims for non-receipt of the current year's issues must be made within six months of the mailing date. address changes must be received at least one 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greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of law emeritus. a.b., juniata college; j.d., george washington university law school. wll.jlamf. harvey, carl m. gray professor of law emeritus. a.b., university of missouri; j.d., il.m., georgetown university law school. w. wll.jlam hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. henry c. karlson, professor of law. a.b., j.d., ll.m., university of idinois college of law. wll.liam andrew kerr, professor of law emeritus. ab., west university; b.s., duke university; j.d., il.m., harvard law school. wll.liam e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern lllinois university; il.b., university of dlinois college of law. kenneth m. stroud, professor of law emeritus. ab., j.d., indiana university­ bloomington. james w. torke, carl m. gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. ab., university of iowa; j.d., il.m., george washington university law school. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. susan boland, head of infot'i'iujtion services. b.a., monmouth college; m.s., university of dlinois; j.d., dlinois university college of law. debra denslaw, reference librarian. b.a, franklin college; m.s., university of dlinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. aa, brewton-parlrer junior college; b.a., georgia southwestern college; ml.s., university of kentucky. wendell e. johnting, assistant director for technical services. ab., taylor university; m.l.s., indiana university. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. stbvenr. mn.1.er, reference librarian. b.s., lebanon valley collegeofpennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh, serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyoshiorsu,automated services and media librarian. a.a., parkland college; a.b., m.s., c.a.s., university of dlinois. indiana health law review volume6 issue l table of contents articles altered standards of care for health care providers in the pandemic influenza ................................................... eleanor d. kinney heather a. mccabe amy lewis gilbert janna jo shisler 1 paging king solomon: towards allowing organ donation from anencephalic infants .............................................. fazal khan notes an athlete's right to privacy regarding sport-related injuries: hippa and the brianlea 17 creation of the mysterious injury ........................................ james blake hike 47 laryngoscopes, lidocaine, and liability: the absence of immunity protection for prehospital providers in indiana ............................................ meghan a. cox 77 unfair and harsh results of contributory negligence lives in indiana: the indiana medical malpractice system and the indiana comparative fault act .................................... bruce d. jones 107 health should not be a determinative factor of whether one will be a suitable adoptive parent ............................. brenda k. devries 137 2009 keith d. barber keith barber is an attorney with the law finn hall, render, killian, heath & lyman, p.s.c. born wahiawa, hawaii, mr. barber received his preparatory education from texas a & m university (b.s., 1981) and post-graduate at baylor university (m.h.a., 1990). after receiving his legal education at the university of houston (j.d., cum laude, 1995) where he was a member of the order of the barons, phi delta phi, he was admitted to the texas bar in 1995 and then indiana in 1996. keith is admitted to practice before the indiana and u.s. district court, southern district of indiana. his professional memberships include american health lawyers association and healthcare financial management association. prior to the practice of law, keith was a captain in u.s. army medical service corps. (1981-1992). mr. barber focuses his legal practice in health law, medicare and medicaid reimbursement, fraud and abuse, and corporate compliance. david b. honig david honig is an attorney with the law firm hall, render, killian, heath & lyman, p.s.c., based in indianapolis, indiana. mr. honig was born in chicago, lllinois and received his preparatory education from washington university, st. louis (b.a., political science, 1984) and his legal education from the university of florida college of law (j.d., with honors, 1987). he was admitted to the florida bar in 1987, lllinois bar in 1992, and the indiana bar in 2()(x). david is also a member of the florida, lllinois, and indiana state bar associations. his professional experience includes: senior attorney, office of the florida attorney general (1996-2()(x)); chief, major case unit, medicaid fraud control unit (1997-2()(x)); and office of janet reno, state attorney for the eleventh judicial circuit, dade county, florida (1987 -1993). mr. honig currently practices in health care fraud and abuse, corporate compliance, medicare and medicaid appeals, and white collar crime. neal a. cooper neal cooper is an attorney with the law firm hall, render, killian, heath & lyman, p.s.c. neal earned his b.s. in accounting in 1988 from millikin university, and earned his law degree in 1998 from the john marshall law school. he is licensed to practice law in lllinois, indiana, and michigan. neal has continuously focused his practice in the area of health care and health economics, having worked for the medicare program for 10 years prior to becoming an attorney. prolific plaintiffs or rabid relators? recent developments 1n false claims acrlmgation keith d. barber* david b. honig** neal a. cooper*** introduction the false claims act1 ("fca"), which penalizes parties who knowingly submit false claims for payment to the government, is arguably the single most potent weapon in the federal health care law enforcement arsenal. part of the potency of the fca is that it provides for a private right of action, paying "whistleblowers'' a bounty of any recovery that results. 2 recent developments in the use of the fca reveal that it may be fertile ground for abuse by private whistleblowers and the government. the fca has played a significant role in federal health care law enforcement, resulting in hundreds of millions of dollars in settlements and judgments for fraudulent false claims.3 it is pos­ sible, however, that fca victories come at a significant cost: compromising innocent defendants' due process rights and imposing substantial duress on those accused. * shareholder, hall, render, killian, heath & lyman, p.s.c., j.d. (cum laude), 1995, university of houston school of law, m.h.a., 1990, baylor university, b.s., 1981, texas a & m university. mr. barber focuses his practice in the areas of medicare and medicaid reimbursement, compliance, and provider appeals. ** associate, hall, render, killian, heath & lyman, p.s.c., j.d. (with honors), 1987, university of florida. b.a., 1984, washington university in st. louis. mr. honig focuses his practice on defense of health care providers in false claims act litigation. *** associate, hall, render, killian, heath & lyman, p.s.c., j.d., 1998, the john marshall law school, b.s., 1988, millikin university. mr. cooper focuses his practice in the area of health care and health economics. the authors wish to thank jennifer a. struck, associate, hall, render, killian, heath & lyman, p.s.c., for her invaluable assistance in the coordination and editing of this article, and susan d. bizzell, shareholder, james m. shafer, associate, and j. brad kallmyer, m.d., law clerk, hall, render, killian, heath & lyman, p.s.c., for their substantial contributions to the completion of this article. 1. 31 u.s.c. §§ 3729-3733 (2002). 2. /d. § 3729(b ). 3. the general accounting office ("gao") reported that since 1996, the department of health and human services' ("hhs") office of the inspector general ("oig") has estimated that medicare improperly paid billions of dollars each year, including more than $13 billion in fiscal year 2002 alone. u.s. gen. accounting office, ga0-03-1030t, federal budget opportunities for 0versighf and improved use of taxpayer funds, statement of davidm. walker,comptrouergeneraloftheunitedstates 15 (july 17, 2003). 136 indiana health law review [vol. 1:131 this article discusses the history of the fca (part i) and recent trends toward potentially abusive prosecution underthefca, including improper use of the complaint seal rules (part ll), predication of actions under the fca based upon alleged stark law violations (part lll), and coercion through the use of oppressive · discovery (part iv). additionally, the article cites numerous examples of situations in which the government arguably has misused the fca (part v). after providing a thorough history and analysis of the fca, this article concludes by encouraging the judiciary to more closely scrutinize the use of the fca and advocating for administrative enforcement reform in the agencies responsible for initiating investigation and prosecution of potential violations of the fca. i. false claims acr the fca, once known as "lincoln's law," was first passed during the civil war in response to fraud in military procurement contracts.4 the statute incorporated the english law concept of the qui tam relator, a whistleblower who brings suit on behalf of the government and receives a percentage of any award. 5 the statute was amended on several occasions, primarily to enhance the qui tam provisions to encourage relators with new information to bring suit while preventing parasitic suits based on public knowledge.6 the most recent amendment to the fca was in 1986.7 that amendment raised the award from double to treble damages, increased the penalties from $2,000 to a range from $5,000 to $10,000, and fine-tuned the qui tam provisions.8 the penalty for violating the fca may also include exclusion from the medicare program, a death knell for many medicare providers.9 in addition to the potential for significant penalties under the fca, the costs, both legal and administrative, to defend against such an investigation can be astronomical depending on the breadth and depth of the investigation. consequently, many innocent health care providers targeted in fca investigations elect to settle rather than defend against the case. since the 1986 amendment, the government and private qui tam relators have applied the statute against medicare and medicaid providers with increasing aggression. since its inception, and prior to the 1986 amendment, 4. act of march 2, 1863, ch. 67, 12 stat. 696. 5. qui tam is short for "qui tam pro domino rege quam pro se ipso in hac parte sequitur," meaning ''who as well for the king as for himself sues in this matter." black's law dictionary 1262 (7th eel. 1999). 6. wercinski v. int'l bus. machs. corp., 982 f. supp. 449, 455-56 (s.d. tex. 1997). 7. falseclaimsamendmentsactof1986,pub.l.no. 99-562, 100stat. 3153 (codified as amended at 31 u.s.c. § 3729 (2004)). 8./d. 9. see, e.g., neal a. cooper, note, third party liability or the false claims act: it is time for consultants to pay the price for their bad advice, 29 j. marshall l. rev. 923, 923-24 (1996). 2004] developments in fca lmgation 137 the fca has applied only to claims that are actually false, such as claims for services never provided, fraudulent invoices,10 mislabeled or shoddy goods,11 and fraudulent statements.12 however, after the 1986 amendment, relators attempted to use the fact that a health care provider personally signs medicare claim forms to expand the fca to include a "false certification" theory. 13 under the false certification theory, a claim that accurately reflects the ser­ vices provided and the fees charged (i.e., true information) could nonetheless be "false" for purposes of the fca if it included an inaccurate certification that the claimant complied with applicable statutes and regulations. 14 some courts have accepted a limited false certification theory, finding it applicable only "when certification is a prerequisite to obtaining a government benefit.••ts the next attempt by the governinent and relators to expand the fca was with an "implied false certification" theory. under the "implied false certifi­ cation•• or "implied certification" theory, a party submitting an otherwise true but unsigned claim form could violate the fca because the submission of the claim itself implies compliance with all laws and regulations affecting the party's right to receive payment under the claim. 16 the implied false certification theory has not been as well received as the false certification theory, and several federal circuit courts have declined the opportunity to accept it.17 10. see, e.g., united states v. ueber, 299 f.2d 310 (6th cir. 1962) (billing overhead, an indirect cost, as time and materials, a direct cost); united states v. aerodex, inc., 469 f.2d 1003 (5th cir. 1972) (providing used aircraft bearings and billing for new bearings). 11. see, e.g., united states v. bomstein, 423 u.s. 303 (1976) (providing falsely branded radio tubes); henry v. united states, 424 f.2d 677 (5th cir. 1970) (providing substandard pine oil disinfectant); united states v. milton marks cmp., 240 f.2d 838 (3d cir. 1957) (providing defective ammunition cartridge clips); united states v. nat' i wholesalers, 236 f.2d 944 (9th cir. 1956) (providing surreptitiously mislabeled motor vehicle generators). 12. see, e.g., united states v. mcn'mch, 356 u.s. 595 (1958) (providing fictitious credit reports to obtain fha loans); united states v. lurie, 222 f.2d 11 (7th cir. 1955) (providing fraudulent certificates in order to procure veterans' preferences in the purchase of war surplus property). 13. see, e.g., united states ex rel hopperv. anton, 91 f.3d 1261 (9th cir. 1996); united states ex rel hill v. california, 129 f.3d 128 (9th cir. 1997) (unpublished table decision). 14. hopper, 91 f.3d at 1266. 15. /d. 16. see, e.g., form cms 1500 (medicare part b claim form) and the certification language thereon; see hopper, 91 f.3d at 1261; see also ab-tech constr., inc. v. united states, 31 fed. cl. 429 (fed. cl.1994), ajj'd, 51 f.3d 1084 (fed. cir. 1995) (unpublished table decision). 17. united states ex rei. willard v. humana health plan oft ex., 336 f.3d 375, 382 (5th cir. 2003); harrison v. westinghouse savannah river co., 176 f.3d 776,787 n.8 (4th cir. 1999); united states ex rei. hafter v. spectrum emergency care, inc., 190 f.3d 1156, 1164 n.8 (loth cir. 1999). 138 indiana health law review [vol. 1:131 ii. false claims act seal provision-8ignificant area of potential abuse a. due process considerations 1. description of seal provision in false claims act by statute, qui tam complaints brought under the fca must be filed in camera (for the judge's eyes only) under seal, with no notification to the defendant, and initially for no less than sixty days. 18 notice is only provided to the defendant upon further order of the court in which the case is filed. 19 at the same time that the suit is filed, the relator must furnish the u.s. attorney general with a copy of the complaint, along with "all material evidence and information the person possesses" concerning the action. 20 within the original sixty-day period following the attorney general's receipt of the relator's complaint and additional documentation, the attorney general must decide whether the government will: ( 1) intervene in the action by filing a notice oflntervention,z1 after which the relator's direct involvement with the case virtually ceases; (2) decline to intervene in the action, in which case the relator may pursue the case without assistance from the government; or (3) move the court to extend the seal for an additional amount of time. 22 it is the third option-extending the seal period-that is ripe for abuse by the govern­ ment and relators resulting in deprivation of a defendant's constitutional due process rights of self-defense. 2. history and original intent of the seal under false claims act the seal provision of the fca is unique in federal civil law, as no other statute allows the filing of a complaint in a civil case under seal. the seal provision was added to the statute in 1986 at the request of the department of justice ("doj") to alleviate the concern that "the public filing of overlapping false claims allegations could potentially 'tip off investigation targets when the criminal inquiry is at a sensitive stage."23 congress granted the doj' s request to a limited extent by adding a provision that requires all relators' 18. the complaint shall be filed in camera, shall remain under seal for at least 60 days, and shall.not be served on the defendant until the court so orders. the government may elect to intervene and proceed with the action within 60 days after it receives both the complaint and the material evidence and information. 31 u.s.c. § 3730(b)(2) (1986). 19. ld. 20./d. 21. ld. 22. ld. §§ 3730(b)(2)-(3). 23. s. rep. no. 99-345, at 24 (1986), reprinted in 1986 u.s.c.c.a.n. 5266, 5289. 2004] · devel..c:>pments in fca lrrlgation 139 complaints to be filed with the ooj under seal for sixty days. 24 senate report 345specd5callysuded: · by providing for sealed complaints, the committee does not intend to affect defendants' rights in any way, ... the initial 60-day sealing of the allegations has the same effect as if the qui tam relator had brought his information to the govern­ merit and notified the govemment of his intent to sue .... the committee feels that with the vast majority of cases, 60 days is an adequate amount of time to allow government coordination, review and decision. consequently, . 'good cause' [as requited for an extension] would not be established merely upon • showing that the government was over­ burc:tened and . had not had a chiilce to addtess the complaint. 25 plainly, extension of the ·sixty-day period is ·not intended to be a tool of administrative fiat, but. rather a. matter of judicial. grace, permissible only where circumstances necessitate. 3. potlntitllfor relatqrs and the government to abuse the seal provision the ·addition of the seal provision to the fca gave both the attorney general and relators the opportunity to abuse the seal provision. the govern­ ment's and relators' temptation to abuse the seal is clear_;_filing suit without being required to notify the defendant for potentially a very long time allows the filing party to gain a significant advantage over the defendant by providing the plaintiff with a significant alilount of t:iine to fully prepare its case before the defendant even knows that l problem exists. during. the time the case is under seal, the government can also conduct extensive pre-trial motions practice (e.g., motions to amend complaint or to transfer the case) ex parte while such motions would otherwise be subject to a defendant's responsive pleadings. such an advantage is arguably given at the expense of the defendant's constitutional due process rights. relators and the government may abuse the seal provisions under the fca in a number of ways, including: (a) the government's solicitation of relators to gain the protection of the seal, which is otherwise only available to the relator, for the government's complaint against a defendant; (b) misrepresentation or falsehoods by the government or relators to inappropriately, and possibly fraudulently, obtain or extend a seal; (c) use ofthe $cal by the government or relators to gain a 24. 31 u.s.c. § 3730(b)(l) (1916) .. 2s. s.rep. no. 99-34.5, at 24-2s. 140 indiana health law review [vol. 1:131 tactical advantage in settlement negotiations with the defendant; and (d) use · of subpoena power during seal period to conduct (perhaps extensive) one­ sided discovery against defendants. a. government solicitation of relators to obtain seal protection under the fca today, the government is able to urge a relator to file a suit and then proceed to simultaneously use the seal as a sword and a shield: threatening to unsheathe it if the defendants refuse to settle while hiding its actions behind it.26 however, the recent history of the fca clearly establishes that the qui tam provisions are not intended to allow private citizens to bring suits. when the government is able to proceed on its own.27 the "[fca] must be analyzed in the context of its twin goals of rejecting suits which the government is capable of pursuing itself, while promoting those which the government is not equipped to bring on its own."28 the sixth circuit in united states ex rel. mckenzie v. bellsouth telecommunications, inc., 29 has considered the history of the fca and the development of the qui tam provisions, noting that prior to 1943, the whistleblower rules "led to abuse," permitting anyone to bring even a parasitic action and receive fifty percent of the amount recovered. 30 the attempt to correct this problem, the 1943 amended statute,31 swung the pendulum too far in the other direction, barring relators from bringing suit "even in cases where 26. see, e.g., improper medkare billing by hospitals nationwille for investigational devkes and procedures: hearing before the s. permanent subcomm. on investigations of the comm. on gov't affairs, 104th cong. 1 (1996) (statement of kevin cosens). in this hearing a relator, kevin cosens, testified before the senate permanent subcommittee on investigations, committee on governmental affairs. mr. cosens testified that, in a case in which the government was already aware of and investigating the underlying acts alleged to constitute false claims, mr. cosens was approached as a witness, and without any additional incentive was cooperating. id. at 8. he next testified: ''finally i was asked ity the office of hhs-ig and the department of justice to come forward as a whistle-blower and encouraged to file a suit under the [fca] based on the false use of medicare billing codes to submit claims for payment for non-covered devices and procedures." id. (emphasis added). mr. cosens' testimony about the government's assistance continued: if my name was to come out, my career would be over. i was asking the government lawyers what type of protection there would be for myself. and the government lawyers mentioned the witness protection program and the federal [fca]. and since my life was not in immediate danger they recommended and explained to me about the federal [fca]. they then gave me the names of three private attorneys and told me to go and seek counsel id. at 14. the government not only encouraged the relator to file a qui tam lawsuit based on allegations they were already investigating, they acted as a referral service for an attorney. 27. united states ex rel. barth v. ridgedale elec., inc., 44 f.3d 699, 704 (8th cir. 1995). 28. id. at 702. 29. united states ex rel. mckenzie v. bellsouth telecomm., inc., 123 f.3d 935 (6th cir. 1997). 30. id. at 938. 31. 31 u.s.c. § 231 (1943) (cwtedt version at 31 u.s.c. § 3729 (2003)). 2004] developments in fca litigation 141 the qui tam plaintiff supplied the information to the government before filing the claim."32 the court found the 1986 statute to be balanced in an attempt to encourage those with information to bring the information forward while avoiding parasitic lawsuits.33 the fca as written today requires that the relator must be the "original source" of the information used to allege a fca violation.34 the mckenzie court concluded that its ruling, requiring the relator "to alert the government that a fraud is being perpetrated against it," did more "to promote the fca' s mission" than if the relator could proceed without prior notice to the government.35 the court twice used the word ·'alert," emphasiz­ ing that the requirement for the relator to provide the initial notification to the government best served the purpose of the fca.36 it is impossible, however, for a relator to provide the initial notification of fraud to the government when the government approached the relator to be a witness in the very investigation for which the complaint is filed. in such a scenario, recruiting a relator only to gain the benefit of the fca seal does nothing to further the fca' s mission because the government already has been alerted to the alleged fraud, but uses a straw man relator to gain the use of the seal in bad faith. therefore, the government's indirect use of the seal becomes abuse because it serves no legitimate government purpose. in order to fully analyze this issue, an instructive discussion of the history of the fca and the intent of congress can be found in wercinski v. international business machines corp., 37 a case involving a motion to dismiss a fca case for lack of subject matter jurisdiction. first, the court noted that in 1943 the "fca was amended to reduce the number of such 'parasitical suits' filed by opportunistic relators who used, as the basis of their fca claim, information already known to the government."38 the court quoted the ninth circuit court of appeals in wang v. fmc corp./9 which stated that "[q]ui tam suits are meant to encourage insiders privy to a fraud on the government to blow the whistle on crime. in such a scheme, there is little point in rewarding a second toot.'>40 the wercinski court then addressed the purpose behind the original source bar, which prevented the government from being forced to share a recovery with a relator when the government was already in a position to conduct an investigation. as the court said: 32. mckenzie, 123 f.3d at 938. 33. /d. at 943. 34. 31 u.s.c. § 3730(e)(4) (2003). 35. mckenzie, 123 f.3d at 943. 36. /d. 37. wercinski v.lnt'l bus. machs. corp., 982 f. supp. 449 (s.d. tex. 1997). 38. /d. at 455. 39. wang v. fmc corp., 975 f.2d 1412, 1419 (9th cir. 1992). 40. wercinski, 982 f. supp. at 456 (quoting wang, 975 f.2d at 1419). 142 indiana healtii law review [vol. 1:131 when, as in this case, the government has been alerted to potential wrongdoing and [is] in possession of all the infor­ mation it needs to begin an investigation, qui tam actions brought by relators whose only contribution is to reinforce what the government already knows are unnecessary, resulting only in a reduction [of] the government's potential recovery.41 the court's analysis of the purpose behind the "original source bar'' applies not only to subject matter jurisdiction, but also to the government's bad faith recruiting of a relator to gain the ability to use the fca seal.42 when the government approaches a potential relator during an investigation, clearly the government is already "alerted to potential wrongdoing" and is "in possession of all the information it needed to begin an investigation." therefore, the government's recruitment of a relator has but one use: to unlawfully purchase a seal at the price of the relator's statutory share of any recovery against the defendant. b. misrepresentations and falsehoods to improperly extend seal just as it is improper and abusive to wrongfully obtain a seal under the fca, wrongfully extending a seal {regardless whether such extension was initially legitimate) is also abusive. the government may, by a showing of good cause, request a judicial extension of the seal.43 reasons given for extensions of the seal by the attorney general {which reasons would also be useful for qui tam relators) have included: the voluminous nature of the investigation,44 settlementnegotiations,45 and the resignation and replacement of doj attorneys assigned to the case.46 in other contexts, these reasons to seek extensions of time may be reasonable; however, in the context of seeking an extension of a seal, which deprives the defendant of his or her due process rights, these rationales are not legitimate reasons for extensions. instead, these rationales may have been engineered to disingenuously extend the seal to allow the opportunity for prolonged, one-sided discovery. cases from the 41. /d. at 460. 42. /d. 43. 31 u.s.c. § 3730(b)(3) (2004). 44. memorandum in support of u.s. application for third extension of time, united states ex rei. cosen v. providence med. ctr., w d. wash., c.a. no. 2:94-974 (no. 16). 45. united states ex rel. costa v. baker & taylor, inc., 955 f. supp. 1188, 1189-90 (n.d. cal. 1997); united states ex rel. lacorte v. smithldine beecham clinical labs., inc., no. civ.a.97-0942, 1998 wl 840012, at *1 (b.d. la. nov. 12, 1998). 46. memorandum in support of u.s. application for fifth extension of tnne, united states ex rel. cosen v. providence med. ctr., w d. wash., c.a. no. 2:94-974 (no. 29). 2004] developments in fca lmgation 143 sealed indictment analysis under the federal rules of criminal procedure, as discussed more fully in subpart 5, are instructive on this point. in united states v. rogers,47 the court found that the government sealed the indictment to pursue an investigation into other charges, hoping to obtain a new indictment and join all the charges for trial. the court stated: in short, this court cannot agree that a unilateral extension by the government of the limitations period under the guise of 'gathering evidence' would be a 'legitimate prosecutorial objective' in view of the length of the delay ... involved and the court's conclusion that the evidence sought to be gathered by the government beyond the limitations period was not related to or necessary for the prosecution of the charges under indictment. 48 in united states v. maroun,49 the court found that the government persuaded the magistrate to seal the indictment by means of an implicit misrepresenta­ tion, and therefore dismissed the indictment. 50 in fact, the entire sealed qui tam action may be an implied misrepresentation by the government if the government already has knowledge of the allegations and has previously investigated such allegation before successfully inducing a relator to file a qui tam action. c. use of seal to gain tactical advantage in settlement negotiations the government's use of the seal in order to gain a tactical advantage in settlement negotiations with the defendant does not further a legitimate government purpose. in united states ex rel. costa v. baker & taylor, inc.,51 the court considered the congressional record of the adoption of the 1986 amendment to the fca. the court noted: the memorandum further suggests that the government has engaged in settlement negotiations with b & t. the defen­ dants are proceeding in these matters based on plaintiffs' representations. they are apparently discussing the settle­ ment of a case without knowing with certainty the allegations leveled against them. each of the plaintiff parties has 47. united states v. rogers,781 f. supp. 1181, 1191 (s.d. miss. 1991). 48. ld. 49. united states v. maroun, 699 f. supp. 5 (d. mass. 1988). 50. ld. at 7. 51. united states ex rei. costa v. baker & taylor, inc., 955 f. supp. 1188 (n.d. cal. 1997). 144 indiana health law review [vol. 1:131 suggested that keeping the file under seal serves the defen­ dants' interests by avoiding unflattering publicity; the court is not, however, convinced that the defendants' current state of ignorance is a blissful one. 52 in addition, the costa court directly refuted any contention that settlement negotiations were a legitimate basis to extend the fca seal by stating, "con­ gress enacted the seal provision to facilitate law enforcement, not to provide an extra bargaining chip in settlement negotiations."53 therefore, under the court's reasoning, any attempt to force a defendant to settle fca claims by filing a sealed complaint or extending a seal is an abuse of the seal provision under the fca. 4. abuse of seal violates defendant's constitutional due process rights while under seal, the statute of limitations is tolled.54 therefore, in cases involving the improper use of the fca, it is likely that the applicable statutes of limitations also have been improperly tolled, trammeling the defendant's constitutional due process protections. a statute of limitations is nothing more than the codification of a defendant's due process right to defend himself or itself prior to the time "when the basic facts may have become obscured by the passage of time. "55 even in the absence of the statute of limitations (or in fca cases, the unusual inapplicability of the statute of limitations), a defendant retains the right to provide a competent defense. 56 the sealing provision of the fca was extensively considered in costa, in which the court noted that "(t]he sixty-day period during which the complaint would be sealed was intended as a compromise, allowing the government to complete its investigation and formulate and adopt a litigation strategy without seriously injuring the interests of the defendant. "57 further, the costa court stated: defendants have a legitimate interest in building their defense while the evidence is still fresh. the public has a right to monitor the activities of government agencies and the 52. ld. at 1190 (emphasis added). 53. id. at 1191 (emphasis added). 54. unitedstatesexrel. wilkinsv.n.am. const.corp.,no.civ.a.h-95-5614,2001 wl 34109383, at *13 (s.d. tex. sept. 26, 2001); united states ex rel. downey v. corning, inc., 118 f. supp. 2d 1160, 1171 (d.n.m. 2001). 55. toussie v. united states, 397 u.s. 112, 114 (1970). 56. u.s. const. amend. v. 57. costa, 955 f. supp. at 1189 (citations omitted) (citing s. rep. no. 99-345, at 23-24 (1986), reprinted in 1986 u.s.c.c.an. 5266, 5288-89). 2004] developments in fca lrrigation courts. in this case, the government appears to be fully engaged in its discovery, without giving the defendants the opportunity even to answer the complaint. 58 145 the costa court concluded that "[t]his practice of conducting one-sided discovery for months or years while the case is under seal was not con­ templated by congress and is not authorized by the statute."59 plainly, the period during which the fca seal is in place, and the concurrent tolling of the statute of limitations, furnishes the government and relators an opportunity to abuse the fca by surreptitiously investigating a complaint of which a defendant is ignorant. 5. analysis of seal violations by analogy to federal rules of crindnalprocedure when a party is sued in private and without notice, the party is deprived of the opportunity to defend itself, thus compromising its right to due pro­ cess. 60 to date, no case law under the fca has stated the proper remedy for the injury to a defendant's due process rights caused by an unreasonably long seal period.61 only in criminal law have courts followed a statutory proce­ dural framework for claims filed under seal.62 thus, the only seal provision comparable to that of the fca, with instructive and comparable case law, is -found in the analogous rule 6( e)( 4) of the federal rules of criminal proce­ dure, which provides: the magistrate judge to whom an indictment is returned may direct that the indictment be kept secret until the defendant is in custody or has been released pending trial. the clerk must then seal the indictment, and no person may disclose the indictment's existence except as necessary to issue or execute a warrant or summons. 63 · the case law interpreting rule 6( e)( 4) creates a three-part inquiry when the sealing of an indictment is challenged. the first test is to determine whether the indictment was sealed for a proper purpose. if not, the indictment 58. id. at 1189-90. 59. id. at 1191. 60. u.s. const. amend. v. 61. but see leland v. target corp., no. 02-c-0815, 2003 wl 22389119, at **6-7 (n.d. dl. oct. 20, 2003) (discussing the role of the due process clause in assessing prejudice from prosecutorial delay and explaining that due process is violated where "a defendant . . . demonstrate[s] that the government intentionally delayed to gain a tactical advantage and that actual prejudice resulted"). 62. fed. r. crim. p. 6(e)(4). 63. id. 146 indiana health law review [vol. 1:131 would not be "found" (i.e., effectively filed for the purposes of the statute of limitations) until it is unsealed. 64 the second test is whether the time the indictment remained under seal (i.e., from the actual filing date until the found date) was reasonable. 65 in the event the period of time during which the complaint was under seal is deemed unreasonable, then the analysis of the third test becomes necessary-whether the defendant was actually prejudiced between the time the indictment was sealed and the time it was unsealed. h the defendant suffered actual prejudice, the statute of limitations would not be tolled, and the indictment would be found as of the date of the unsealing. 66 a. first test-legitimate government purpose the first test in determining whether a sealed lawsuit should relate back to the original filing date is whether the indictment or complaint was sealed for a legitimate government purpose.67 neither the use of the seal for tactical advantages nor the provision of false or misleading information to obtain or extend the seal furthers a legitimate government purpose. 68 the first test examines both whether the action was properly sealed and whether the seal was properly extended. these queries have been previously explored in part ii.a.3, discussing abuses of the fca seal provisions. b. second test-reasonableness of length of seal the second of the three tests in determining whether a sealed lawsuit will relate back is a determination of the reasonableness of the seal's duration. as noted in part ii.a.2, the congressional record reveals congress' belief that sixty days "is an adequate amount of time to allow [g]overnment coordination, review and decision."69 the senate report goes on to state: "the [g]ovemment should not, in any way, be allowed to unnecessarily delay lifting of the seal from the civil complaint or processing of the qui tam litigation."70 therefore, extending the seal significantly beyond the initial 64. united states v. shell, 961 f.2d 138, 141 (9th cir. 1992), reh'g granted, 974 f.2d 1035 (9th cir. 1992) (opinion withdrawn on other grounds); united states v. srulowitz, 819 f.2d 37,40 (2d cir. 1987); united states v. southland corp., 760 f.2d 1366, 1379-80 (2d cir. 1985); united states v. michael, 180 f.2d 55, 56-57 (3d cir. 1949). 65. sheu, 961 f.2d at 141; srulowitz, 819 f.2d at 40; southland, 760 f.2d at 1379-80; michael, 180 f.2d at 56-57. 66. shell, 961 f.2d at 142; united states v. thompson, 287 f.3d 1244, 1248 (loth cir. 2002); united states v. watson, 690 f.2d 15, 16-17 (2d cir. 1979). 67. united states v. maroun, 699 f. supp. 5, 6 (d. mass. 1988); united states v. rogers, 781 f. supp. 1181, 1190 (s.d. miss. 1991); united states v. sharpe, 995 f.2d 49, 52 (5th cir. 1993); thompson, 287 f.3d at 1252. 68. see discussion infra part ii.a6. 69. s. rep. no. 99-345, at 24-25 (1986), reprinted in 1986 u .s.c.c.a.n. 5266, 5289-90. 70. /d. at 25. 2004] developments in fca lmgation 147 sixty-day period may be deemed unreasonable, paving the way for further analysis under the third test in determining relation back. c. third test-substantial prejudice to defendant (i) in general-showing of prejudice necessary the third test to determine whether a sealed action should relate back to the original filing date upon its unsealing is whether the defendant is able to show substantial prejudice from the delay.71 some courts have determined that the length of delay itself is sufficient to create a presumption of prejudice, as enunciated by the u.s. supreme court in doggett v. united states.12 in doggett, the court stated: [i]mpairment of one's defense is the most difficult form of speedy trial prejudice to prove because time's erosion of ex­ culpatory evidence and testimony 'can rarely be shown .... ' thus, we generally have to recognize that excessive delay presumptively compromises the reliability of a trial in ways that neither party can prove or, for that matter, identify.73 the applicability of federal rule of criminal procedure 6(e)(4) to fca cases and to defendant's due process right to a timely defense was discussed at length in united states v. watson.14 the watson court began by noting that the tolling of the statute of limitations by the filing of an indictment was normally reasonable, as a defendant was put on timely notice by the filing of charges.75 the watson court then compared such a public filing to the filing of a sealed indictment and concluded that in a non-public filing, such tolling was not facially reasonable, as the defendant was not put on notice by a secret document. 76 the court concluded that "there must be limits . . . on the [g]ovemment's privilege to toll the statute of limitations by a sealed indict­ ment.'m the decision in watson was later revised to add that "when the defendant can show substantial prejudice, the indictment must be dismissed, 71. thompson, 287 f.3d at 1254; sharpe, 995 f.2d at 51; united states v. srulowitz, 819 f.2d 37, 40 (2d cir. 1987). 72. doggett v. united states, 505 u.s. 647 (1992). doggett was a speedy trial case, but the analysis of time depriving the defendant of the ability to demonstrate prejudice is equally applicable to a due process argument. 73. ld. at 655 (citation omitted). 74. united states v. watson, 599 f.2d 1149 (2d cir. 1979), modified, united states v. muse, 633 f.2d 1041 (2d cir. 1980). 75. ld. at 1154. 76.ld. 77. jd. 148 indiana heal til law review [vol. 1:131 for even a legitimate prosecutorial interest is then insufficient to effectuate statute of limitations policies. "78 one of the most significant prejudices suffered by a defendant as a result of an extraordinary delay in prosecution is its inability to identify with particularity the content and relevance of documents it would have had in its possession had the government proceeded within a reasonable period of time. if a defendant were required· to demonstrate prejudice for· even the most "patently unjustified delay of virtually limitless duration," a due process violation could not be found, even when the inability to demonstrate prejudice was caused by the delay.79 such a rule would "give the government carte. blanche, creating potential for abuse,"80 and would reward the government for intentional or negligent delay. a defendant may also demonstrate substantial prejudice from the government's intentional destruction of potentially exculpatory records; for example, the government periodically orders medicare fiscal intermediaries to "[ d]iscard any [pacemaker-related] files that. . . . have accumulated. "81 following this discarding of documents, it is possible that the government could sue a defendant claiming that the defendant did not advise it of the specific information that the government had previously possessed, but destroyed. simply stated, the government may keep an investigation under seal while (perhaps inadvertently) ordering the destruction of exculpatory evidence that directly refutes its allegations. medicare peer review organizations ("pros"), or quality improvement organizations ("qios"), which are under contract with the government, review procedures performed by medicare providers to determine their medical necessity.82 pros have the authority to refuse payment or require repayment if a procedure is not medically necessary. 83 in instances when a pro or qio specifically reviewed a claim and determined the item or service provided was medically necessary, it would strongly support the defendant if the govern­ ment's or relator's allegation is that the defendant knowingly submitted claims for medically unnecessary items or services. however, the records of these .·medical ·necessity determinations are destroyed after six years. pur8uant to government policy.84 therefore, if. a case is under se8.1 for a sufficient duration, it is possible that the records will be destroyed before the govern­ ment has filed its notice of intervention. 78. united states v. watson, 690 f.2d 15, 16 (2d cir. 1979). 79. united states v. deglomini, 111 f. supp. 2d 198, 203 (e.d.n.y. 2000). 80. id. 81. ctrs. formedicare & mbdicaidservs., u.s.dep'tofhealth&humanservs., pub. n0.13-3, medicare intermediary manualpt 3,transmittal no. 1730 (1997). 82. ctrs.formedicare&medicaidservs., u.s.dep'tofhealth&humanservs., pub. no. 100-10, quality improvement organization manual§ 4125 (2()03). 83. /d, § 1005. 84. /d. §§ 15720, 15750. 2004] developments in fca lidgation 149 case law abounds holding that a defendant cannot be found to have knowingly violated the fca when such defendant can demonstrate that the government was fully advised of the action and paidthe claim anyway.85 in yale-new haven hospital, inc. v. thompson, 86 a federal court held that "[t]he fact that the intermediaries continued to pay for these services for a period of eight years after the manual provision was disseminated could reasonably be interpreted by [the hospital] that payment would continue to be made" and that such payment constituted "conflicting information" from the govern­ ment.87 the yale-new haven hospital court determined that this, at a mini­ mum, created an issue of fact for trial. 88 thus, at least one court has deter­ mined that evidence of government awareness and tacit approval of a hospital's conduct is potentially exculpatory. a gross delay by the govern­ ment in intervening in a case years after its investigation was "substantially complete," combined with its destruction of exculpatory records in its possession, deprives a defendant of the ability to defend itself, and is a classic deprivation of the very idea of due process. (ii) where a seal has been extended beyond the applicable limitations period, a showing of substantial prejudice may not be necessary the government's decision to keep a case under seal must have a legitimate basis, or else it may constitute prejudice to the defendant per se. in united states v. deglomini,89 the court stated that "[w]here the government has no legitimate purpose served by keeping the indictment sealed beyond the expiration of the limitations period, the defendants need not show prejudice, even if the indictment was properly sealed."90 the deglomini court consider­ ed the government's argument that a defendant must demonstrate prejudice where there was an unreasonable delay in unsealing an indictment, conclud­ ing, "[t]he policies underlying the statute of limitations ... suggest that no showing of prejudice ought to be required when the government unreasonably delays unsealing the indictment."91 the court further reasoned: 85. see united states ex rel. becker v. westinghouse savannah river co., 305 f.3d 284, 289 (4th cir. 2002) (citations omitted) ("in such a case, the government's knowledge effectively negates the fraud or falsity required by the fca. "); united states ex rei. durcholz v. fkw, inc., 189 f.3d 542, 545 (7th cir. 1999) ("the government's prior knowledge of an allegedly false claim can vitiate a fca action."); united states ex rel. humphrey v. franklin-williamson human servs., inc., 189 f. supp. 2d 862, 867 (s.d. ill. 2002) ("[t]he government's knowledge effectively negates the fraud or falsity required by the fca."). 86. yale-new haven hosp., inc. v. thompson, 162 f. supp. 2d 54 (d. conn. 2001). 87. ld. at 68. 88. ld. 89. united states v. deglomini, 111 f. supp. 2d 198 (e.d.n. y. 2000). 90. ld. at 200. 91. ld. at 202. 150 indiana healtii law review [vol. 1:131 extending the prejudice requirement to the case sub judice, where the government unreasonably delayed· unsealing the indictment and the limitations period consequently was not tolled, would undermine the statute of limitations. one of the primary purposes of statutes of limitations is 'to protect individuals from having to defend themselves against charges when the basic facts may have become obscured by the passage of time and to minimize the danger of official punishment because of acts in the far-distant past.' in recognition of this 'overwhelming concern,' courts liberally construe statutes of limitations in favor of repose. the danger in allowing the government free rein to toll the limita­ tions period by sealing indictments was well-articulated in united states v. sherwood. 92 in united states v. sherwood,93 the court found a thirteen-month delay in unsealing a criminal complaint unreasonable and prejudicial as a matter of law. the court stated: the five-year criminal statute of limitations would have little or no meaning were the law to be construed otherwise. a person would never know with certainty that a sealed indict­ ment might be lurking in undisclosed government files, held in abeyance for a year or years to satisfy the personal motives of a government official. 94 on this same issue, the deglomini court opined: requiring a showing of actual prejudice to the defendant would give the government carte blanche, creating potential for abuse. at the theoretical extreme, even a patently unjustified delay of virtually limitless duration would toll the limitations period, so long as the defendant is unable to meet the burden of proving actual prejudice to his defense as a result of the delay. 95 92. /d. at 202-03 (citations omitted). 93. united states v. sherwood, 38 f.r.d. 14 (d. conn. 1964). 94. id. at 20. 95. deglomini, 111 f. supp. 2d at 203. 2004] developments jn fca litigation 151 6. the duty of candor to the court in ex parte proceedings when the government seeks permission for an extension of the seal from a court, the government bas an obligation to abide by the american bar association model rule of professional conduct 3.3( d), which states, "in an ex parte proceeding, a lawyer shall inform the tribunal of all material facts known to the lawyer that will enable the tribunal to make an informed decision, whether or not the facts are adverse. •>96 the rule is explained in the comment section of the model rule: "the judge bas an affirmative responsi­ bility to accord the absent party just consideration. the lawyer for the represented party bas the correlative duty to make disclosures of material facts known to the lawyer and that the lawyer reasonably believes are necessary to an informed decision.'.n this model rule and its commentary are relevant because it is critical to the protection of the due process rights of the defendant to ensure that the government's stated basis for the extension of the seal are legitimate.98 in the bearing discussed above, the senate committee specifically found sixty days to be an adequate amount of time to allow government coordination, review, and decision-making and that good cause would not be established merely upon a showing that the government was overburdened and bad not bad an opportunity to address the complaint99 further, the senate committee believed the government should not be allowed to unnecessarily delay lifting the seal from the civil complaint or processing the qui tam litigation.100 the obligations of an ex parte litigant also obligate the government to advise the court of relevant law, even if it is contrary to the government's position.101 the costa court noted that "[t]he sixty-day period during which the complaint would be sealed was intended as a compromise, allowing the government to formulate and adopt litigation strategy without seriously injuring the interests of the defendant."u12 query whether serious injury to the interests of a defendant would result from the government's prolonged, ex parte, unilateral participation in the development of a cause of action, during which the court is informed only of the law supporting the case against the defendant. the seal provision, as described by congress and in the legislative history, bas a legitimate government purpose. the practical use of the seal, 96. model rules ofprof'lconduct r. 3.3(d) (2002). 97. id. cmt. 14. 98. see discussion supra part ll.a. 99. s. rep. no. 99-345, at 25 (1986), reprinted in 1986 u.s.c.c.a.n. 5266, 5289-90. 100. id. 101. model rules ofprof'l conduct r. 3.3(d) (2002) ("in an ex parte proceeding, a lawyer shall infonn the tribunal of all material facts known to the lawyer that will enable the tribunal to make an informed decision, whether or not the facts are adverse."). 102. united states ex rei. costa v. baker & taylor, inc., 955 f. supp. 1188, 1189 (n.d. cal. 1997) (citation omitted). 152 indiana health law review [vol. 1:131 however, has in many cases crossed the line that separates legitimate from illegitimate purposes. by using the seal in a manner contrary to law, the government erodes the legitimacy of the seal itself. it may come to pass that congress revisits the necessity of the seal, and could determine that, because of the history of improper use, the seal no longer promotes any legitimate government purpose. b. statute of limitations no fca claim may be filed as of the latter of: (1) six years after the date the alleged fca violation is committed or (2) three years after the date when the material facts of the claim should have been known, ''but in no event more than [ten] years after the date on which the violation [was] com­ mitted."103 this section creates a two-tiered statute of limitations period: a baseline six-year period, or an extended period, up to a total of ten years, calculated by adding up to three full years from the time the material facts were known or should have been known by the relevant government official. the statute of limitations period in fca cases is not tolled until the claim is filed in a forum in which the plaintiff has a good faith intention of proceeding. 104 in biby v. kansas city ufe insurance co., the plaintiffs filed a complaint in the central district of california against two defendants, one a missouri resident and the other an arkansas resident.105 the plaintiffs filed the complaint just days before the limitations period expired, and serious doubt existed as to whether the california court could exercise personal jurisdiction over the defendants.106 the plaintiffs did not attempt to serve the defendants, but instead, sought and obtained an ex parte order transferring the case to the eastern district of arkansas ten days after filing the complaint. 107 on appeal, the eighth circuit held that the statute of limitations period was not tolled by the filing of the suit in california.108 in affirming the district court's dismissal, the eighth circuit explained that "[s]ome measure of good faith expectation of proceeding in the court in which the complaint is filed is essential to tolling the statute of limitations. a filing of a complaint which is merely a procedural ploy will not suffice."109 the court in united states v. st. 103. 31 u.s.c. § 373l(b) (2003). 104. biby v. kan. city life ins. co., 629 f.2d 1289, 1294 (8th cir. 1980); united states v. st. joseph's reg'l health ctr., 240 f. supp. 2d 882, 892 (w.d. ark. 2002). 105. biby, 629 f.2d at 1290. 106. ld. at 1292. 107. id. 108. id. at 1294. 109. ld. (citations omitted); see also chandlerv. roy, 272f.3d 1057, 1059 (8th cir. 2001) (affirming the holding in biby but distinguishing the facts and stating, "the reasonableness of a party's decision to select a forum is not dispositive; our focus instead is on the party's intent to proceed in that forum."). 2004] developments 1n fca litigation 153 joseph's regional health center,110 a case in which a relator filed suit in the eastern district of pennsylvania against one hundred hospitals from around the corintry alleging violations of the fca, found the holding in biby controlling and dispositive. in st. joseph's, the relator alleged that venue was proper because some of the defendants were pennsylvania hospitals. 111 the st; joseph's relator, however; did not allege any "conspiracy or concert of action or joint and several liability between the defendants."112 the st. joseph's complaint was filed under seal and no attempt was made to serve the hospital while the case was pending in pennsylvania. instead, the government sought repeated extensions of the seal and its time to elect to intervene, causing the case to remain under seal for more than five years.113 before it intervened in the case, the government sought and obtained an ex parte order severing the claims against the out-of-state hospitals and transferring them to districts where jurisdiction and venue were proper. 114 the claims against st. joseph's were transferred to the western district of arkansas, where st. joseph's finally had an opportunity to object to transfer, albeit after the fact. 115 the western district of arkansas dismissed the claims ~gainst st. joseph's as tim.e barred.u6 the government argued that the relator's origi­ nal pennsylvania action provided the relative date for statute of limitations purposes.117 in rejecting the government's argument, the st. joseph's court held that "abuse of the [fca] procedure cannot justify the tolling of the statutes of limitations!'118 the st. joseph's court noted that the relator's position on venue "was predicated on a misjoinder of parties."119 the court also noted many other ''procedural irregularities," including the government's failure to serve st. joseph's in the pennsylvania proceeding and the ex parte severance and transfer of the claims against st. joseph's.120 the st. joseph's court affirmed its prior dismissal and rejected the government's arguments, reiterating that biby remains good law, and noting · that the eighth circuit cited biby as recently as 2001 in chandler. 121 the st. joseph's court explained: 110. united states v. st. joseph's reg'l health ctr., 240 f. supp. 2d 882 (w.d. ark. 2002). 111. id. at 886. 112. id. 113. id. at 888. 114. id. at 887. 115. ld. at 888. 116. st. joseph's reg'l health ctr., 240 f. supp. 2d at 888-89. 117. id. at 888. 118. id. 119. id. at 886. 120. id. at 888. 121. id. at 891 (citing chandler v. roy, 272 f.3d 1057 (8th cir. 2001)). 154 indiana health law review [vol. 1:131 [w]here a plaintiff deliberately selects an improper forum; makes no effort to serve the defendant in that forum so that the defendant cannot seek to correct the error; makes the transfer request itself--ex parte-for its own purposes; and never had any intention of prosecuting the claim in the forum of filing, there is no analytical basis for the filing to toll the , statute of limitations. 122 as biby and st. joseph's demonstrate, for a transferred case to relate back to an earlier filing, the government must demonstrate that the earlier filing was made in a forum that was proper or in which the plaintiff had a good faith expectation of proceeding. claims under the fca may be filed "in any judicial district in which the defendant or, in the case of multiple defendants, any one defendant can be found, resides, transacts business, or. in which any act proscribed by [31 u.s.c. §] 3729 occurred."123 in a claim with multiple defendants, venue is properly laid if any one defendant "can be found, resides, transacts business, or [performs any act proscribed by 31 u.s.c. § 3729]"' in the district, but only if the defendants are properly joined under rule 2q of the federal rules of civil procedure, which permits joinder only if the defendants are jointly or severally liable or if the claims against them arose from the same transaction or occurrence.124 dl. falsecla.lmsacr&stark recent case law and current litigation matters reflect a development in fca complaints: allegedly false claims predicated on a violation of the federal self-referral prohibitions of the starklaw.125 a self-referral that is not exempt from the stark law or that does not qualify for an exception to its prohibitions is unlawfu1.126 relators have alleged that a claim submitted in violation of the stark law gives rise to fca violations, because the claim is automatically "false" given the strict liability nature of the statute. the 122. st. joseph's reg'l health ctr., 240 f. supp. 2d at 891-92 (footnotes omitted). 123. 31 u.s.c. § 3732(a) (2003). 124. john t. boese. civil false claims and qui tam acrions § 5.06(a)(1) (2d ed. 2002) ("[i]f venue is proper as to one defendant in a jurisdiction, it is proper for all other defendants in the same proceeding who are involved in the same false claims. this does not mean, however, that defendants who are accused of similar, but unrelated, conduct may all be sued in the same district."). rule 20 provides, "all persons ... may be joined in one action as defendants if there is asserted against them ..• any right to relief in respect of or arising out of the same transaction, occurrence, or series of transactions or occurrences and if any question of law or fact common to all defendants will arise in the action." fed. r. civ. p. 20(a). 125. 42 u.s.c. § 1395nn (2003). 126. id. § 1395nn(a). 2004] developments in fca lmgation 155 conclusion is, however, a non sequitur because a stark law violation does not require a "knowing" submission of a false claim. the fca requires that the allegedly false claim must have been sub­ mitted "knowingly."127 under the fca, a false claim is submitted "know­ ingly" if it is submitted despite actual knowledge of the falsity of the informa­ tion; in deliberate ignorance of the truth or falsity of the information; or with reckless disregard of the truth or falsity of the information.128 the stark law, however, has no such knowledge requirement. 129 a claim submitted in violation of the stark law is a violation without regard to intent, so the stark law is essentially a strict liability statute. thus the fca and the stark law have dichotomous scienter criteria. a brief history of the stark law is necessary to put context to the interplay between the stark law and the fca. a starklaw the stark law, which first became effective on january 1, 1992 (stark 1), prohibited referrals to a clinical laboratory with which the referring physi­ cian had a non-exempt "financial relationship."13° congress amended the stark law in 1993 to have a delayed effective date, except with respect to clinical laboratory services, until "after december 31, 1994," so that the secretary of hhs could. promulgate regulations pursuant to 42 u.s.c. § 1395nn(g)(6)(c).131 after the 1993 amendment, the statute was known as stark ll and was significantly expanded in scope to apply to a much wider range of items and services. 132 the secretary did not promulgate any proposed regulations under stark it until january 1998.133 in response to that delay, the house ways and means subconunittee on health held hearings on '.'the health care finance adminis­ tration's (hcfa) implementation of the medicare self-referral laws and its impact on the health care marketplace," beginning may 13, 1999.134 at these hearings, representatives of hcf a assured congress that final regulations 127. 31 u.s.c. § 3729(a) (2003). 128. /d.§ 3729(b). 129. see 42 u.s.c. § 1395nn. 130. ld. § 1395nn(a)(1)(a). 131. omnibusbudgetreconciliationactof1993,pub. l. no. 103-66, § 13562,107 stat. 312,604-05 (1993). 132. id. § 13562, 107 stat. at 596-605. 133. medicare and medicaid programs; physicians' referrals to health care entities with which they have fmancial relationships, 63 fed. reg. 1659 (proposed jan. 9, 1998). 134. medicare self-referral laws: hearing before the subcomm. on health of the house comm. on ways and means, 106th cong. 2 (1999); see ab-tech const., inc. v. united states, 31 fed. cl. 429,433-35 (fed. cl. 1994) (discussing the damages incurred by the government in a false claims case), aff'd, 51 f.3d 1084 (fed. cir. 1995). hcfa has since been renamed centers for medicare & medicaid services (cms). this article will refer to the agency alternately as cms and hcfa, based on the time frame being discussed herein. 156 indiana health law review [vol. 1:131 would be completed in a rea.sonable period of time. however, hcfa did not issue the first ''phase" of final regulations until january 4, 2001, to become effective january 4, 2002.135 on january 20, 2001, the white house issued a memorandum to the acting heads of executive departments and agencies, ''temporarily postpon[ing] the effective date of the regulations for ;[sixty] days" for all published, but not yet effective, regulations. 136 therefore, the effective date of the fmalized stark ll regulation became march 5, 2002 . . b. stark and the false claims act since the 1986 amendment to the fca, relators have attempted on many occasions to bring suits based on violations of stark n. 137 the applicability of stark n has been considered in light of the plain language of the statute,,and cases predicated upon stark n have been decided based on specific facts and circumstances. 138 none of the reported cases, however, demonstrates a challenge to the use of stark n in fca cases based on its legislative and regulatory history. a review of the history of stark n since its codification, at least until the effective date of phase i of the final regulations, will demonstrate that a qui tam relator cannot show that a health care provider knowingly violated stark ll or that medicare would have withheld payment based on alleged stark ll violations. the essence of a stark ll-based fca suit is that a claim, while factually accurate, must have been the product of a referral for a designated health service from a physician with a non-exempt financial relationship with the entity to whom the referral is made. 139 such a claim is purportedly rendered false because it contains, either explicitly or implicitly, a certification that the provider complied with all applicable statutes and regulations. if "certifica­ tion of such compliance is a condition to payment," a false claim could be 135. medicare and medicaid programs~physicians' referrals to health care entities with which they have financial relationships, 66 fed. reg. 856 (jan. 4, 2001) (codified at 42 c.f.r. pts. 411, 424). 136. memorandum for the heads and acting heads of executive departments and agencies, 66 fed. reg. 7702 (jan. 24, 2001). 137. see, e.g., united states ex rel. thompson v. columbia/hca healthcare corp., 20 f. supp. 2d 1017 (s.d. tex.1998). 138. see, e.g., united states ex rei. willard v. humana health plan of tex., 336 f.3d 375, 381-83 (5th cir. 2003); harrison v. westinghouse savannah river co., 176 f.3d 776, 787 n.8 (4thcir. 1999); united states exrel. hafterv. spectrum. emergency care, inc., 190f.3d 1156, 1164 n.8 (loth cir. 1999); united states exrel. perales v. st. margaret's hosp., 243 f. supp. 2d 843, 867 (c.d. ill. 2003). 139. 42 u.s.c. § 1395nn(ax1) (2003); see, e.g., perales, 243 f. supp. 2d at 843; united states ex rei. goodstein v. mclaren reg'l med. ctr., no. 97-cv-72992-dt, 2001 u.s. dist. lexis 2917 (b.d. mich. jan. 3, 2001). 2004] developments in fca lltigation 157 alleged.140 however, the historical application of stark n, since its codifica­ tion in 1993, reveals that compliance was not a condition of payment. 1. the stark law was not a condition of payment prior to march 5, 2002. stark i.· provided,. and stark ti provides, that the entity to which a prohibited referral is made may not bill the medicare program for such . service.141 as explained below, however, the government agency charged with interpreting stark nand paying medicare claims stated that it would not enforce the statute. on may 4, 1999, the. house ways and means subcommittee on health held a· hearing on the implementation of stark ll.142 the purpose of this hearing,.as announced-on may 4, 1999, was to "focus on implementation of existing self-referral statutes and on areas for reform."143 the hearing was­ required because, as chairman bill thomas noted in announcing the hearing: physicians and hospit8j.s are subject to a bewildering array of . overlapping state. and federal statutes. many of the steps physicians and hospitals take to integrate their practices are subject to a multitude of laws, including self-referral law, anti-kickback law, federal tax law regulating the conduct of tax-exempt organizations, state referral bans, corporate prac­ tice of medicine prohibition and the federal [fca]. the fact that it has taken the hcfa more than 6 years to put out a · final rule is further evidence that these laws are in need of an · overhaul.144 even after ch8innan · thomas made these comments, hcfa continued delaying promulgation offinal rules for another three years. at the hearing, the first witness to testify before the committee was kathleen a. buto, deputy director of the center for health plans and pro­ viders, hcfa. ms. buto testified that hcfa was struggling with proposed stark rules, describing the identification and definition of appropriate excep­ tions to "'protect beneficiaries' access to care and to -take into account the many detailed fuiancial arrangements" in modem health care to be a "daunting task.'h45 ms. buto testified that, at that time, hcfa was undertaking "[n]o 140. unitedstatesexrel joslin v. cmty. homehealtbofmd.,inc., 984f. supp. 374,385 (d. md. 1997) (emphasis in original}. 141. 42 u.s.c. § 1395nn(a). 142. medicare self-referral laws. supra note 135, at 2. 143. id. at 3. 144. id. at 2-3. 145. ·id. at 13. 158 indiana health law rev1ew [vol. 1:131 other type of enforcement actions [other than spot checks and complaint investigations] until outstanding questions [were] resolved and a final rule [was] published."146 according to hcfa, the agency tasked with paying medicare claims, stark n was not being enforced in 1998 and would not be enforced for several more years. ms. buto' s testimony regarding hcf a's refusal to enforce stark n was supported by other testimony before the committee. chairman thomas began the hearing by observing that "not a single case has been prosecuted under the [stark] self-referrallaws."147 he went on to state that "since federal investi­ gators use the self-referral law to threaten physicians and hospitals, even though the status of the law is unclear, that seems to me a tacit admission that compliance is virtually impossible and that it only serves as a means to bully providers.'' 148 hcfa did not enforce stark ll between the effective date of the statutory amendment and the effective date of phase i of the final regulations, march 5, 2002. compliance with stark ii, therefore, was not a medicare condition of payment for a claim for health care services, so the elements of the false certification theory that make such certification a false claim cannot be met. any fca actions brought prior to march 5, 2002 for claims allegedly submitted in violation of stark n should be defeated on summary judgment because compliance with the stark law was not a condition of payment until it was enforced. 2. a violation of the stark law cannot be a "knowing" violation an essential element of a suit brought under the fca is that the defendant "knowingly" submitted a false claim. 149 "knowing" is defined as (1) actual knowledge of the information; (2) deliberate ignorance of the truth or falsity of the information; or (3) reckless disregard of the truth or falsity of the information. tso a false certification can only· be the basis of a fca suit when it involves a knowingly false certification of compliance with a statute or regulation.151 simply stated, nobody could have knowingly submitted a false certification of starkll compliance because, prior to the issuance of final rules, nobody knew what the statute meant 146. id. 147. ld. at4. 148. medicare self-refe"al laws, supra note 135, at 5. 149. 31 u.s.c. § 3729(a) (2003). 150. ld. § 3729(b). 151. united states v. southland mgmt. corp., 288 f.3d 665, 678 (5th c'tr. 2002); see also united states ex rel. augustine v. century health servs., inc., 289 f.3d 409, 416 (6th cir. 2002); united states ex rei. hopperv. anton. 91 f.3d 1261, 1266-67 (9th cir. 1996); luckey v. baxter healthcare corp., 2 f. supp. 2d 1034, 1049 (n.d. m. 1998); united states ex rel. joslin v. cmty. home health ofmd.,lnc., 984 f. supp. 374, 383 (d. md. 1997). 2004] developments in fca lmgation 159 chairman thomas quoted sir thomas more's utopia in his opening remarks, stating, ''it is unjust to bind the people by a set of laws that are too many to be read and too obscure to be understood:'152 he noted that "we are further from clarity in this area of the law than probably any other area of health policy."153 the sponsor of the law, fortney "pete" stark. representa­ tive, observed that ''the complexity of the law has been an embarrassment,"154 and wrote in a letter introduced at the hearing that "the controversy drags on and many providers who seek to do the right thing find themselves caught in uncertainty ."155 nancy l. johnson, representative, stated, "i am appalled that we, in the government, could pass a law and not tell people what we mean by it for [six] 6 years."156 ms. buto, the aforementioned hcfa deputy director, testified that hcfa was trying ''to clarify the law and create appropriate flexibility."157 she told the committee, "we continue to evaluate the 12,800 comments we have received on the [1998] proposed rules and are open to ideas to further simplify the regulations and the law itself in ways that do not undermine its intent."lss d. mccarty thornton, fonner chief counsel to the inspector general, office of the inspector general, hhs, stated that the law had ''been subject to considerable criticism, resulting from ambiguity in how the law applies to certain particular types of business arrangements among physicians and other health providers."159 the concerns of the committee members and enforce­ ment agencies were supported by testimony from representatives of the health care industry. one witness, sanford teplitzky, past president of the national health lawyers association, testified: i have appeared on numerous panels with representatives of hcfa and the oig during which this legislation has been discussed. those individuals have been quite honest and candid in responding to questions. however, their responses have not constituted for the most part, answers. rather, they respond with their own questions, assumptions, and predic­ tions of what the final regulations might look like. this is simply unacceptable to the great majority of providers who want, need, and deserve answers. i cannot provide definitive guidance to my clients.160 152. medicare self-referral laws, supra note 135, at 4. 153. /d. 154. id. at 10. 155. id. at 9. 156. id. at 31. 157. id. at 13. 158. medicare self-referral laws, supra note 135, at 13. 159. id. at 18. 160. id. at 59. 160 indiana health law review [vol. 1:131 c. david morehead, m.d., president. scott & white health plans, testifying on behalf of the american medical group association, stated: it is only fair, however, that we know what the law means and what the rules are before we are held accountable for them. the original version of this law is now almost ten years old, and we still don't know how to apply them to deliver medical care in our communities. 161 the written statement of the stark law coalition, who also testified at the . hearings, was that. given "the ambiguity of the statutory language, it would be manifestly unjust for hcf a to enforce this statute before adopting legally binding regulations."162 prior to the effective date of phase i of the stark n regulations, nobody knew how to interpret or implement 42 u.s.c. § 1395nn. providers did not know how to comply and their attorneys could not furnish bright-line advice. neither the hcfa nor the 010 posed anything more than questions anq predictions of their own. not even congress could tell people the meaning of the law they wrote. fortney stark, the aforementioned sponsor of the legislation that bears his name, decried the uncertainty for providers trying to meet the strictures of the law he described as an embarrassment 163 health care providers could have known of, been deliberately ignorant of, or have recklessly disregarded a stark. n violation in certifying a claim to medicare, because the law was literally unknowable prior to the date the fmal regulations became effective on march 15, 2002.164 stark d was passed in 1993, but did not take effect until1995. this delay was written into the statute to give hcfa time to draft rules to interpret and enforce the statute. because no regulations under the statute took effect until march 2002, and because hcfa refused to enforce the statute until the rules were in place, an allegation that a claim violated stark n and thus gave rise to a case brought under the fca certification theory should be unsustain­ able for pre-march 2002 claims. such a relator could not prove that com~ pliance with the statute was a condition of payment or that a provider knew of a violation to the statute. these arguments would not be terribly effective, however, for claims filed on or after march 2002, and defendants must find other grounds to refute the new breed of fca claims of false certification. 161. /d. at 71 (emphasis in original). 162. /d. at 148. 163. /d. at 10. 164. certain stark law violations are not subject to the finer points of the stark law, and this article does not suggest that any prohibited referral prior to phase i would have been innocent. to the contrary, many aspects of the stark law are straightforward. where the analysis goes beyond the basics of the stark law, however, comprehensibility quickly devolves. 2004] developments in fca lmgation 161 iv. limiting the breadth of quit am relators' discovery counsel for fca plaintiffs have been creative in crafting novel causes of action under the fca. 165 two federal district courts have limited such lawsuits by ruling that a case under the fca does not grant the plaintiff unfettered access to a defendant's business records through the discovery process. 166 these decisions, perhaps pioneering a trend in judicial limitation of fca discovery, portend relief for health care providers from onerous and overreaching discovery requests. one of the most disturbing trends in false claims law for health care providers has been the filing of general allegations by qui tam relators who hope to create a case through the discovery process. discovery in a qui tam case, which can include every claim submitted to medicare or medicaid over a six-year period, is extraordinarily onerous.167 courts have rejected fca complaints without specific factual examples to support a relator's general allegations, however, based on the requirement in rule 9(b) of the federal ·rules of civil procedure 168 that such cases be pled in greater detail than usual civil actions. 169 more specifically, rule 9(b) requires that the circumstances­ who, what, when, where, and how-constituting the alleged fraud be stated in the relator's complaint.170 rule 9(b) has been applied to the fca to require specificity in pleadings thereunder. 171 the plaintiffs' bar responded to the application of rule 9(b) to fca complaints by ffiing qui tam actions alleging "tens of thousands" of violations, but including at least one specific example of the alleged fraud. courts have accepted such pleadings by example to be adequate under the federal rules 165. 31 u.s.c. §§ 3729-33 (2003). 166. united states ex rel. grandeau v. cancer treatment ctrs. of am., no. civ.a.99c8287, 2003 wl 21504998, at *2-3 (n.d. ill. june 30, 2003); united states ex rel. stewart v. la. clinic, no. civ.a.99-1767, 2003 wl 21283994 (e.d. la. june 4, 2003). 167. see, e.g., grandeau, 2003 wl 21504998, at *3. 168. rule 9(b), regarding pleading special matters, states in its entirety: "(b) fraud, mistake, condffion of the mind. in all averments of fraud or mistake, the circum­ stances constituting fraud or mistake shall be stated with particularity. malice, intent, know­ ledge, and other condition of mind of a person may be averred generally." fed. r. civ. p. 9(b ). 169. see, e.g., ackerman v. northwestemmut. life ins. co., 172 f.3d467, 469 (7th cir. 1999); united states ex rel. robinson v. northrop corp., 149 f.r.d. 142, 145 (n.d. ill. 1993). 170. ackennan, 172 f.3d at 469; robinson, 149 f.r.d. at 145. 171. see, e.g., united states ex rel. clausen v. lab. corp. of am., inc., 290 f.3d 1301, 1320-21 (11th cir. 2002), cert. denied, 537 u.s. 1105 (2003); united states ex rel. branhan v. mercy health sys. of southwest ohio, no. 9803127, 1999 u.s.app. lexis 18509, at *7 (6th cir. aug. 5, 1999) (unpublished table decision); united states ex rei. cooper v. blue cross & blue shield of fla., inc., 19 f.3d 562, 568 (11th cir. 1994); united states ex rei. franklin v. parke-davis, 147 f. supp. 2d 39,46 (d. mass. 2001); united states ex rel. drake v. norden sys., inc., no. civ.a.3:94-cu-963, 2000 wl 1336497, at *5 (d. conn. aug. 24, 2000); united states ex rei. gublo v. novacare, inc., 62 f. supp. 2d 347, 354 (d. mass. 1999). 162 indiana hbaltii law review [vol. 1:131 of civil procedure.172 thus, in a claim under the fca, the relator must plead with particularity the identity of the person who made the alleged false claim, the time, place, and content of the alleged false claim, and the method by which the alleged false claim was communicated to the government. once a pleading is accepted by the court as having been pled with sufficient particularity, discovery may begin. the court must simply decide how much discovery to permit. the initial query is whether the pleading of only a single claim should lead to discovery on only that claim, or should give a plaintiff the "keys to the kingdom" by allowing discovery as to all of the defendant's claims andrelatedrecords and files. two courts, one in louisiana and one in dlinois, have recently answered that question in favor of the health care provider.173 the reasoning in each case, that discovery should be limited to only those claims pled with particularity but not those merely generally alleged, provides a cogent analysis of the issue. a. united states ex rel. stewart v. louisiana clinic on june 4, 2003, the u.s. district court for the eastern district of louisiana limited the scope of a relator's discovery to the time period and patients enumerated in her complaint.174 the magistrate who issued the opinion followed the direction of the district court judge who ordered, "[r]elators should not view this ruling as carte blanche to conduct a fishing expedition. although allowing relators to proceed with this 'bare minimum' pleading, this [c]ourt will remain guided through discovery by the principles behind rule 9(b).''m this ruling was part of the district court's caution "against 'fishing' for additional claims" and was based upon its observation ''that the right of action granted to private citizens is quite limited, i.e., the right to proceed on behalf of the united states is limited to those citizens who 'have independently obtained knowledge of the fraud. "'176 the stewart court also specifically addressed whether an allegation of conspiracy may allow a relator greater depth of discovery. the relator in stewart alleged conspiracy to commit false claims, but the court found the circumstances of a conspiracy conspicuously absent from her pleadings.177 ''the issue of a menacing scheme or conspiracy is wholly absent in this case and all claims against the louisiana clinic have been dismissed.''178 the 172. see, e.g., united states ex rel. regan v. medtronic, inc., no. civ.a95-1236-mlb, 2000 wl 1478476 (d. kan. july 13, 2000). 173. united states ex rei. grandeau v. cancer treatment ctrs. of am., no. civ.a.99c8287, 96-1309-mlb, 2003 wl 21504998 (n.d. dl. june 30, 2003); united states ex rel. stewart v. la. clinic, no. civ.a.99-1767, 2003 wl 21283944 (b.d. la. june 4, 2003). 174. stewa11, 2003 wl 21283944, at *8-12. 175. id. at *9. 176. id. at *8 (citation omitted). 177. id. 178. id. at *9. 2004) developments in fca lmgation 163 district judge, in granting the relator limited discovery as to counts other than the conspiracy allegations, "specifically held that relators had been given ample opportunity to identify fraud, noted that the balance of the equities in this case weigh against further leave to amend, [and] proscribed further proceedings bent on 'finding fraud during the discovery process. "'179 the court then found that the fca is concerned not with a "menacing underlying scheme," but with the submission of a claim alleged to be false. 180 the court did state, however, that conspiracies or continuing patterns of wrongful conduct may require a more expansive scope for discovery, when the necessary facts are pled with particularity as required by rule 9(b). 181 the court was not persuaded by the relator's arguments in favor of more expansive discovery and determined that the burden of responding to factual allegations outside the scope of the complaint far outweighed the possible relevance of such evidence.182 the relator in stewart cited a case to support her request that the court grant greater discovery authority in which the court held that the relator sought to use "a broadsword where a scalpel would suffice. "183 the stewart court, addressing the relator's request to be permitted expansive discovery beyond the scope of that related to the claims plead with particular­ ity, indicated that evidence of a conspiracy must be sufficiently significant as to outweigh the burden of production.184 b. united states ex rel. grandeau v. cancer treatment centers of america on june 30, 2003, the u.s. district court for the northern district of lllinois decided united states ex rel. grandeau v. cancer treatment centers of america. 185 in that case, the relator alleged "some specific circumstances of the alleged fraud," including explicitly naming some patients. 186 the defen­ dants in that case provided discovery related to the named patients only. the relator made additional discovery requests, which the defendants estimated 179. /d. 180. stewart, 2003 wl 21283944, at *9. 181. ld. at *10. 182. id. 183. ld. at*ll (citingunitedstatesexrel. regan v. medtronic, inc.,no. civ. a. 95-1236mlb, 96-1309-mlb, 2000 wl 14784767 (d. kan. july 13, 2000)). /d. 184. ld. at *12. [d]efendants in the case at bar have sufficiently demonstrated that compliance with temporally and topically overly broad discovery requests would threaten the normal operation of their respective businesses and that the result of such a costly exercise would likely yield voluminous data of no significance to the alleged false claims. 185. united states ex rel. grandeau v. cancer treatment ctrs. of am., no. civ.a.99c8287, 2003 wl 21504998, at*9 (n.d. dl. june 30, 2003). 186. /d. 164 indiana health law review [vol. 1:131 would have required production of approximately two million pages. 187 the court considered the balance of interests, the conflict between the stringent pleading requirements in fraud cases, and the onerous burden such a discovery would create.188 the court's analysis is reproduced here in its entirety: this· case well represents a continuing conundrum in qui tam cases. the relator is supposed to be an insider, one who advances claims she knows about because of her unique position that the government does not know. and fraud must be pleaded with particularity. but the breadth of the claims may be such that alleging all the "who, what, when and where" of the claims would lead, ultimately, to an extremely long, complex and incomprehensible complaint. still, a qui tam action is not a roving commission to investigate all the financial dealings of the defendants. here the relator has alleged some specific examples. that saves the complaint from total dismissal. in other allegations there are no specific examples, or the examples alleged are somewhat general or lack the who or the when. relator contends she can add details as necessary and talks about filing another amended complaint. we think the better way to proceed is by tailoring discovery to the specificity of the claims, as we previously attempted to do until discovery on the qui tam claims was stayed pending ruling on these motions. judge ashman can, then, permit discovery as the relator provides an adequate foundation for it. 189 the effect of the court's ruling in grande au was to permit the relator to proceed with discovery in a suit brought under the fca only so far as fraud was pled with particularity. in other words, the complaint, pled in general with some specific examples, was treated as a complaint alleging only those examples. c. lessons learned from grandeau and stewart grandeau and stewart stand for the proposition that a qui tam case pled with the minimum particularity to survive scrutiny will yield only a minimum . of discovery. these cases suggest that health care providers will be able to limit discovery, which in a fca claim is extraordinarily voluminous, expen­ sive, and time-consuming, when a relator's complaint is based on isolated 187. ld. at *2. 188. id. 189. id. at *2 (citation omitted). 2004] developments in fca lmoation 165 allegations of billing irregularities. the fca requires more than a technical error to serve as a foot in the door allowing relators to force open discovery and conduct an open-ended, court-authorized fishing expedition in the defendant's records in anticipation of finding a case brought under the fca. if grande au and stewart, both decided by federal district courts, represent the future of fca discovery, relators will no longer be able to use the threat of unwieldy discovery requests to coerce settlements that a defendant would otherwise reject. v. provider backlash against abusive enforcement a. the oig's former chief counsel's attack on the "backlash" in 1999, former chief counsel to the inspector general for hhs, mccarty d. thornton, claimed federal enforcement efforts created the benefi­ cial "sentinel event" of increased health care provider concern for compliance with medicare billing requirements.190 mr. thornton complimented the health care industry for cooperating with the overall effort to promote compliance and for the reduction in the payment error rate associated with the submission of medicare claims.191 he alsc> noted the assistance provided by the office of the inspector general in developing model compliance plans and issuing advisory opinions directed at making rules more clear for providers.192 however, mr. thornton criticized the health care industry for alleged hyperbole and for "inaccurate, excessive rhetoric" associated with provider "backlash" against the fraud enforcement efforts, and he discounted any provider concerns that the government is (or has been) over-zealous in its fraud enforcement effort.193 in his article, mr. thornton represented the oig, and other federal enforcement agencies, as understanding and beneficent entities that only invoke powerful statutory tools, such as the fca, when clearly justified.194 he also claimed that the oig "does not disparage medical professionals or medical enterprises," understands that "the great majority of them are working ethically," and is "mindful of the differences between negli­ gent errors and mistakes ... and reckless or intentional conduct."19s thornton dismissed as unreasonable provider fears that they would be ''prosecuted for some trivial offense."196 190. mccarty d. thornton, "sentinel effect" shows fraud control effort works, 32 j. healthl. 493 (1999). . 191. /d. ("many providers· have reacted to the enforcement effort in a healthy way by devoting significant resources to compliance efforts.''). 192. id. at 497-98. 193. id. at 494, 499. 194. ld. at 498-99. 195. id. 196. thornton, supra note 191, at498;.99, 166 indiana healtii law review [vol. 1:131 mr. thornton's portrayal of the government's approach is difficult to reconcile with the many examples of the government's zealous enforcement initiatives. numerous providers have been snared by a net cast widely over the industry. a common provider concern is that the government fails to give sufficient consideration to the complex and often vague nature of the rules. providers believe government fraud enforcers act on interpretations of the rules that are not apparent on the face of the rules and impose those interpre­ tations in a retroactive fashion. these provider concerns are supported by court decisions that are highly critical of the government's tactics and by some of the government's own documents and representations. b. the courts have criticized government abuses some of the most targeted criticism against the government's actions has come, not from the industry, but from the federal courts. in united states v. krizek/91 the judge described the government's treatment of health care providers under the fca as ''plainly unfair and unjustified," and the court refused to impose liability under the fca based on the government's "strained interpretation of the cpt [billing] codes."198 the court chastised the govern­ ment for failing to provide "clear guidance as to what services are reimburs­ able."199 when the government continued to pursue its prosecution of dr. krizek. even after this unusually strong condemnation of its actions by a federal court, a clearly exasperated judge sporkin, in a subsequent decision, stated that "[t]he [g]ovemment insists on pursuing a case that should long have been over."200 judge sporkin wrote, ''the [g]overdm.ent's pursuit of dr. krizek is reminiscent of inspector javert's quest to capture jean valjean in victor hugo's les mise rabies •.. there comes a point when a civilized society must say enough is enough. "201 judge sporkin went on to cite in a footnote "overzealous use of the [fca]" as a basis for recent guidance from the u.s. deputy attorney general to use the statute more carefully and congressional "consideration of a bill that would set limitations on the use of this statute. "202 one of the government fraud enforcement initiatives most criticized by the health care industry is associated with the national outpatient laboratory billing initiative named "operation bad bundle" by the government. 203 this 197. united states v. krizek, 859 f. supp. 5, 10 (d.d.c. 1994). 198. id. at 10. 199. ld. 200. united states v. krizek, 7 f. supp. 2d 56, 60 (d.o.c. 1998). 201. /d. 202. ld. at 60 n.4. 203. dep't of health & human servs., office ofinspecfor gen., semiannual re­ port october 1,1997 -march31, 1998, at 7 (1998). 2004] developments in fca litigation 167 initiative accused hospitals of "unbundling"204 outpatient laboratory claims for multi-channel chemistry services and for improperly billing "additional indices" in violation of the fca. the laboratory billing initiative was the subject of two court decisions in which the ohio hospital association and the american hospital association sued for injunctive and declaratory relief against the initiative. 205 these two decisions present compelling evidence of judicial criticism for overly aggressive government tactics and strained legal interpretations. in the first decision, the trial court dismissed the suit against the govern­ menton technical jurisdictional grounds.206 however, this was a rather hollow victory for the government as the trial court took the unusual step of going out of its way to comment on some of the substantive issues. the court repeatedly called the government's tactics "heavy handed" and stated that there was a "very real possibility that the secretary's position regarding the hospitals' billing practices is wrong."207 the court even went so far as to suggest that the government's approach of threatening fca prosecution for these issues danced on the edge of attorney ethical violations. zos the ohio hospital association appealed the dismissal of its case to the sixth circuit court of appeals. on december 29, 1999, the court of appeals reversed the dismissal and released a decision that again validated the concern of health care providers regarding the government's tactics and legal posi­ tion. 209 the court of appeals stated: the secretary has never initiated a rulemaking proceeding under the administrative procedure act to formalize the billing standards she now espouses. neither has she initiated administrative proceedings to recoup the alleged· overpay204. "unbundling" is the proces11 of billing separate components of tests perfonned as a single panel that can be billed at a single panel or global rate. see dep't of justice, healthcare fraud report--fiscal years 1995-1996 (1997), reprinted in healthcare compliance rep. (cch)! 350,001 (aug. 13, 1997). 205. dep't of health & human servs., office of inspector gen., supra note 204, at 7. 206. ohio hosp. ass'n v. shalala, 978 f. supp. 735,742 (e.d. ohio 1997). 207. ld. 208. "[i]ftheattomey general's threatened [fcaj prosecution was criminal in nature, the actions of government counsel could be in breach of the mandatory ethical standards contained in the ohio code of professional responsibility." ld. at 738 n.3. it is notable that while the [fca] is technically civil in nature, a supreme court interpretation in effect at the time the judge made this comment regarded the harsh financial penalties under the [fca] as so punitive that they were treated as criminal in nature for purposes of constitutional double jeopardy clause evaluation. see united states v. halper, 490 u.s. 435,450-51 (1989). this interpre­ tation was later reversed by the supreme court in hudson v. united states, 522 u.s. 93 ( 1997). however, even in hudson, the court stated that the excessive fines provision of the eighth amendment applies to the fca. ld. at 103. 209. ohio hosp. ass'n v. shaiala. 201 f.3d 418,419 (6th cir. 1999). 168 indiana heal til law review [vol. 1:131 ments. instead, as part of a sweeping investigation ... the secretary has allegedly used ... elements of the department of justice to coerce the hospitals into retroactively accepting revised standards and paying the secretary large sums of money under threat of having to pay much more if the hospitals decline to enter into settlement agreements .... 210 when placed iil the context of well-established law requiring that any legally binding substantive rules be promulgated under the administrative procedures act, 211 this statement by the court of appeals is compelling. the description by the court of appeals that the secretary's actions are ''to coerce the hospitals into retroactively accepting revised standards"212 clearly suggests the secretary's actions have no legal basis and validates the exact concerns raised by the health care industry regarding this matter. the government appealed the decision to the u.s. supreme court, but the supreme court refused the government's request to hear the appeal. 213 any claims that the government has reformed its practices cannot be sustained in light of the fact that government continues to "coerce hospitals into retroactively accepting revised standards'" in operation bad bundle initiatives that continue in many states to this day, even after these court · decisions. c. the government's own documents prove abuse of the law operation bad bundle represented a clear case of government fraud enforcers acting on interpretations of guidelines not apparent on the face of the guidelines. perhaps the strongest evidence of this comes from three separate red book reports from the oig. the "red books" are a collection of cost savings recommendations from the oig that have not been impl0mented.214 three separateredbookreports for 1995,1996, and 1997-1998 recommended that hcfa implement a rule requiring bundling of panel tests because no such rule existed. 210. id. 211. see shalala v. guernsey mem'l hosp., 514 u.s. 87, 99 (1995) (holding that policies · issued without the benefit of notice and comment under the administrative procedures act "do not have the force of law and are not accorded that weight in the adjudicatory process"). 212. ohio hosp. ass'n, 201 f.3d at 419. 213. shalala v. ohio hosp. ass'n, 531 u.s. 1071, 1071 (2001). 214. dep'tofhealtii&humanservs., 0fficeofinspeci'or gen., the 1996red book . 40(1996)(emphasis added). all threeredbooksfrom 1995,1996, and 1997-1998 contained identical language recommending implementation of a bundling requirement, because no such requirement existed. id. for additional information substantiating the lack oflegal basis for this initiative see also the special report to the american hospital association: development of government guide lines for hospital outpatient laboratory reimbursement, prepared by jones, davis, reavis & pogue (mar. 1998). 2004] developments in fca lmgation medicare policies are not sufficient to control the billing of profile tests becaus.e there is no requirement that tests ordered as a panel by the physician be billed only as a panel. the hcfa's guidelines do not address the problem ... of the industry billing tlie contents of the panels individually.215 169 in short, the government has accused health care providers of violating a rule that its own reports say never existed. d. the three-day window rule investigation is another example of abuse another example of an initiative supporting provider concerns that the government is not acting fairly is the "3-day window rule" initiative.216 in this initiative, the government threatened hospitals with fca lawsuits for alleged failures to catch circumstances where outpatient diagnostic services were furnished within three days prior to an inpatient admission. 217 while mr. thornton claimed the 010 understands ''the great majority" of health care providers are "working ethically," this enforcement initiative was directed at the vast majority of acute care hospitals in the united states. 218 in some states every acute care hospital received a letter from the u.s. attorney for the middle district of pennsylvania claiming that "it has been determined that your institution should be civilly prosecuted pursuant to this [fca]."219 thus, 215. id. 216. the law establishes that most outpatient services furnished by a hospital (or any wholly owned or operated entity of the hospital) within tbree days prior to an inpatient admission to the hospital are regarded as paid for in the prospective payment system (or dro) payment to the hospital. 42 u.s.c. § 1395ww(ax4) (2002). 217. id. 218. a 1995 010 report identified 4,660 hospitals nationwide to be targeted with allegations that they violated the fca in regard to the 3-day window rule. dep'tofhealth & human servs., office of the inspector gen., report no. a-03-94-00021, status report-office of the inspector general/department of justice joint project­ medicare nonphysician 0ui'patient brls submitfed by hospitals 2 (1995). this represents almost every acute care hospital in the nation. the 010 report openly admitted there would be no validations of the specific claims or allegations for the 4,660 hospitals involved, because "of the resources required to conduct validations" and because the government's proposed settlement was so much "more generous than the penalties under the [fca]." id. at 6. of course this means the government simply presumed the hospital's conduct violated the fca to begin with, and proves the government's willingness to accuse hospitals of violating the fca without validating its information on an individual hospital basis. the 010 report also made clear that it would impose a single ''model settlement agreement with all4,660 hospitals included. in the project." /d. 219. for example, this exact language appeared in all113 letters sent to every acute care hospital in indiana. the highly threatening letters went so far as to calculate the potential · liability under the fca (of treble damag~ and $5,000 per claim). because of the frequently 170 indiana heal 'ill law review [vol. 1:131 the oig's platitude that it believes .that ''the great majority" of health care providers are "working ethically'' is not consistent with the reality of the government claiming ''the great majority'' of hospitals in the nation should be prosecuted or required to accept settlements for "knowingly'' submitting false claims to the government. 220 mr. thornton claimed that providers have no basis for any "fear ofbeing prosecuted for some trivial offense," but again, real examples associated with the 3-day window rule investigation suggest otherwise;221 the government sent highly threatening letters without regard for the materiality of the offense.222 these letters asserted specific false claims spanning a four-year period from 1990 to 1994.223 a particularly egregious example of how the government's approach was devoid of specific fact evaluation involves an indiana hospital that received a letter informing the hospital that its case had been referred for pro­ secution under the fca.224 for the entire four-year period reviewed, the hospital had but a single alleged erroneous claim totaling $60.07, the recovery of which supposedly justified the government's claim that the hospital had "knowingly" submitted false claims to the government. 225 large numbers of claims involved, this was an extraordinarily high level of damages, completely disproportionate to the conduct alleged and was highly intimidating to the hospitals receiving the letters. for example, for the 1131ndianahospitals involved, the government's total assertion of ovmpayments was only $2,251,102. thus, the government claimed all 113 hospitals knowingly submitted false claims to increase their income by an average of$5,000 per year for each hospital. the government noted that the liability of the 113 hospitals under the fca was $192,162,736. in short, the government threatened hospitals with a damage multiplier of nearly 100 times actual damages if they did not settle the case. see id. at 7 for a chart stating the number of hospitals targeted in the first seven states under the initiative with estimates of liability under the fca if the hospitals did not settle.· 220. the fca allows liability only when the defendant ''knowingly presents, or causes to be presented ... a false or fraudulent claim for approval." 31 u.s.c. § 3729(a) (2002). the fca defines ''knowingly" as actual knowledge, deliberate ignorance, or reckless disregard for the falsity of the claim. ld. § 3729(b). 221. thornton, supra note 191. 222. see, e.g., letter from united states department ofhealth and human services, office of inspector general, b!utimore, md., to all hospitals in united states (various dates, 1996) (on file with authors). 223. id. 224./d. 225. during negotiations on this matter, the government's explanation for this hospital's treatment was that the letter was issued by a computer generated mail merge system that simply sent such letters without any regard for the specific circwnstances of any hospital. this only proves how completely devoid of any factual investigation the government's allegations were. in short, it was character assassination by mail merge. the government still required the hospital to sign a settlement and pay the $60.01. no apology for the heavy-handed threat of fca violations was ever offered to the people who work for and administer the hospital. 2004] developments in fca litigation 171 e. government responses to the "backlash" admit abuse the government's efforts to address the "backlash" contradict mr. thornton's claim that provider concerns are baseless. in response to strong complaints from the health care industry, on june 3, 1998, the doj released guidance for ooj use of the fca.226 in a june 5, 1998 cover letter forwarding the new guidance to the american hospital association, john t. bentivoglio claimed the guidance was issued to address "legitimate concerns that have been raised [regarding] our efforts."227 in a speech on february 1, 1999 to the american hospital association, deputy u.s. attorney general eric holder admitted that there had ''been understandable concern within the industry" for what "have been, at times, heavy-handed treatment by the govemment."228 the ooj claims that the guidelines were implemented and have ended government excesses related to the fca. 229 not only do many of the recent examples of abuse in the prior sections of this article contradict that claim, but also the government's own reports reject the doj' s conclusion. 230 on february 3, 1999, deputy attorney general eric holder released the results of a ooj sixth-month self-evaluation that, not surprisingly, found the guidance had ''been extremely effective" in addressing earlier problems.231 however, independent government reviews contradict the doj' s conclusions. the united states general accounting office ("gao"), in a review of the "doj' s implementation of false claims act guidance," described the ooj' s oversight of its subordinate u.s. attorneys' offices' compliance with the guidance as "superficial.''232 the report also noted that at the time fca allegations related to the laboratory billing initiative were made, "most offices had not adequately analyzed the data to determine if the apparent errors were sufficient to warrant a false claims violation" and that "these 226. memorandum from eric holder, deputy attorney general, to all united. states attomeys(june3,1998), reprintedinhealthcarccomplianceguide(cch)attachmentll-3-a, available at http://www.usdoj.gov/d4foialreadingrooms/chem.htm. 227. letter from john t. bentivoglio, special counsel for health care fraud, u.s. department of justice, office of the attorney general, to richard davidson, president of the american hospital association (june 5, 1998) (on file with authors). 228. eric h. holder, jr., remarks to the american hospital association (feb. 1, 1999), reprinted in healthcare compliance rep. (cch) 1444,005, available at http://www.usdoj. gov/archive/daglspeech/holderahaspeech.htm. 229. /d. 230. see u.s. gen. accounting or"'ce, gaoihehs-99-170, medicare fraud and abuse: doj's implbmbntation of false claims acr guidance in national lnitiatives varies 4 (aug. 6, 1999). 231. memorandum from eric h. holder, jr., deputy attorney general, to all united states attorneys (feb. 3, 1999), reprinted in healthcare compliance rep. (cch)1350,002, available at http://health.cch.comlprim.esrclbinlhighwire.dll?a=dd&a val=cchdoc28&brsl=7968. 232. u.s. gen. accounting c>ffiqi. p.tpra note 231, at 18. 172 indiana health law revmw [vol. 1:131 offices lacked evidence that each of the hospitals had knowingly submitted false claims."233 critical as this gao report may seem, it actually gave every benefit of the doubt to the doj. the gao sought input from state hospital associations regarding their perceptions of the doj's implementation of its fca guidance.234 the gao admitted that almost all negative responses "related to the laboratory unbundling initiative" and that .. [t]he most often voiced criticism was that this initiative lac:ked a legal basis."235 yet, even though this was the most serious concern, the gao admits that it "did not evaluate the legal merits of any of the doj's national initiatives."236 the gao only verified that the doj performed its own legal analysis. in short, there has been no oversight of the doj for the crucial question of the legal sufficiency of the doj' s arguments in the laboratory unbundling initiative, even though the gao admits that this is the most serious concern of the provider community. since the doj guidance requires an evaluation. of the "legal predicates'' for any national initiative, the failure of the gao to address this concern means that there has been no independent review of whether the doj conducted a meaningful evaluation of the "legal predicates" for the laboratory unbundling initiative. f. the costs of abuse to the health.care system the government's abusive investigation practices do not have small consequences. they disrupt the provision of health care services by forcing providers to divert often-substantial resources,. time, and human capital to respond. 237 in addition, the government routinely uses the threat of the draconian penalties under the· fca to coerce unjust settlements that often include payment of penalties that further divert resources from the provision of health care. 238 not for profit health care organizations, dedicated to charit­ able care, are often included in the target list of broad sweeping health care· fraud initiatives. the penalties paid by these organizations can only be viewed as directly penalizing the most vulnerable in our society in their need for health care services. payment of such penalties might be justified if the 233. id. at 18. 234. /d. at 3, 5, 16. 235: id. at 16. 236. id. at 16 n.9. 237. see generally pamela h. bucy, the path from regulator tq hunter: the exercise of prosecutorial discretion in the investigation of physicians at teachinghospitals,44 st. louis l.j. 3 (2000). responding to a fraud investigation can be enormously burdensome, and the government generally requires the hospital to prove its innocence. this often requires sorting through and producing enormous amounts of documents. often extensive and expensive consultation with legal counsel is also required. 238. /d. at 41, .46. 2004] developments in fca lidgation 173 government initiatives clearly targeted actual cases of fraud. however, as discussed in this article, this is simply not always the case. it is true that the "great majority" of health care providers are "working ethically."239 had the government consistently treated health care providers with this kind of assumption, the "backlash" would be less of an issue. how­ ever, the government has assumed, and continues to assume, that providers are guilty of "knowingly" submitting false claims (until they prove themselves innocent) in all too many cases where the government's post hoc interpreta­ tion of vague rules and guidelines determines providers submitted claims in error. vi. conclusion health care fraud is, without question, a significant problem in the united states today. the remedies employed against this problem, however, may cause more harm than good. the use of the fca has devolved from a tool for fraud prevention to a tool for virtual extortion. it is clear that fca plaintiffs, both the government and its relators, use the significant weight of a fca lawsuit to lean on health care providers in an illegitimate attempt to gain rewards, either economic or egoistic, in a manner inconsistent with the intent of the law. a relator's desire to receive a percentage of the recovery or of a government official to gain media exposure, however, does not justify the strong-arming of health care providers. the fca is too potent a weapon to be used indiscriminately, and it is incumbent upon the federal judiciary to reign in abuses, congress to assess the necessity of a statutory correction, and the administrative enforcement bodies to develop the necessary restraint to stop the abuse and misuse of the fca. 239. thornton, supra note 191, at 498-99. see also, hearing before the subcomm. on health of the comm. on ways and means, house of rep., l06th cong. 34 (1999) (regarding physicians' compliance with the stark law) (statement of rep. mccrery) (stating that "maybe we should ... not assum[ej that all physicians ... are crooks"); id. at 54 (statementofk. buto, dep. dir., ctr. for health plans & providers, health care fin. admin.) ("we are assuming that the providers are complying with the [stark] statute."). leslie p. francis leslie p. francis is alfred c. emery professor of law; professor and chair, department of philosophy; and a member of the division of medical ethics in the department of internal medicine at the university of utah. she received her ph.d. in philosophy from the university of michigan in 1974 and her j.d. from the university of utah in 1981. she was a law clerk to judge abner mikva of the united states court of appeals for the district of columbia circuit in 1981-82. professor francis specializes in ethics, bioethics, philosophy of law, health law, and disability law. she is the author of a number of articles on issues in philosophy of law, health care, and professional ethics. her most recent books are land wars: the politics of property and community (with john g. francis, lynne rienner publishers 2003), and sexual harassment as an ethical issue in academic life (roman and littlefield 2001). she also has edited (with anita silvers) americans with disabillties: impucations of tiffi law for individuals and institutions (routledge 2000). she is currently a member of the american law institute (elected 1986), chair of the program committee for the pacific division of the ap a, and immediate past president of amintaphll.... in the spring of 2000, she was awarded the university's rosenblatt prize for overall excellence in research, teaching, and academic service. legitimate expectations, unreasonable beliefs, and legally mandated coverage of experimental therapy leslie pickering francis* introduction photographs of patients seeking contributions for expensive bone marrow transplants are an everyday image on supermarket checkout stands. benefit concerts, newspaper stories, and community fundraisers pitch in to help patients who cannot otherwise afford expensive medical interventions. patients with multiple myeloma lined up to testify before the medicare coverage advisory committee about the lifesaving possibilities of "their'' bone marrow transplants.' many of the patients who are the subjects of these appeals have health insurance, but their insurance has denied coverage because the care has been judged to be experimental or not reasonably medically necessary. behind these appeals for funding lies the judgment that these patients are not receiving care to which they are entitled-at least, care to which they are sufficiently entitled to deserve community support for their fundraising efforts. are these patients justified in their claims? should health insurance routinely cover the costs of experimental therapy? do patients have a moral claim that their legitimate expectations have been disappointed when the care is not covered? patients and their advocates understandably urge coverage, especially when the therapy is expensive and lives are apparently on the line. in contrast, understandably, insurance plans would prefer to limit coverage for expensive interventions of marginal value. ideally, all are interested in ensur­ ing that patients receive proper care while also reducing the likelihood of ineffective or dangerous interventions. in the midst of this debate, a number of states have recently enacted coverage mandates for off-label drug uses and for patient participation in clinical trials (see part iv). one policy goal of at least some of these statutes is to ensure that patients receive therapeutically beneficial care. alabama, new jersey, and tennessee, for example, mandate coverage for patients receiving prescriptions for certain off-label drug uses; their stated legislative purpose is that the patients' "expectation that their * leslie pickering francis, ph.d., university of michigan, 1974; j.d., university of utah, 1981; alfred c. emery professor of law and professor and chair, department of philosophy, university of utah. 1. drugs, biologics, & therapeutics advisory panel, medicare coverage advisory comm., minutes of the june 15, 1999 meeting, available at http://www.cms.gov/mcac/sb 1d5.asp? origin=globalsearch&page=/mcd/viewmcac.asp?id=lo. 216 indiana health law review [vol. 1:213 health care costs will be paid by their insurance policies is not disappointed. "2 this statutory policy apparently assumes that patients' legitimate expectations for therapeutic care extend to the covered off-label uses. an additional statutory justification for the coverage mandates is the desire to encourage the development of evidence-based medical knowledge about new therapies. further justifications are drawn from distributive justice concerns-all patient populations should be included in the development of new medical knowl­ edge, and promising new therapies should be available on an equitable basis. this article explores whether "legitimate expectations" for treatment are a persuasive moral reason to mandate insurance coverage of experimental therapy. it argues that legitimate expectations for coverage of therapeutic care extend only to limited cases of experimental interventions. some of the statu­ tory mandates exceed this justification in significant ways. reasons based in justice and in evidence-based medical knowledge support some mandated coverage, but this logic does not rest primarily on the patient's own entitle­ ment to care. moreover, the encouragement of patients' expectations that ex­ perimental care will be funded may continue to induce problematic litigation by patients seeking the coverage. a principal example is coverage of high­ dose chemotherapy with stem cell support for patients with breast cancer, which is a politically and emotionally charged issue but is by no means unique. i. the reasonableness of expectations and the legitimacy of beliefs this essay is part of a larger project exploring the moral import of expectations. the goal of the larger project is to explore when, if ever, and why the fact that people have formed expectations-beliefs about the future that they treat with an attitude of reliance-matters morally to how they ought to be treated. respecting expectations is an aspect of treating people as choosers and planners of their lives; it is part of what we must do if we are to respect autonomy in practice. but not all expectations matter, and some that do matter bear only limited moral weight. one critical aspect of whether and with what weight expectations make a difference to how people ought to be treated is whether the expectations are based in reasonable beliefs. this aspect of expectations-the reasonableness of the beliefs on which they are based and their resulting moral significance-is the subject of this article. in enacting these statutes, the legislatures of alabama, new jersey, and tennessee stated explicitly that their goal was to protect the legitimate expectations of patients. these expectations, as the legislatures understood them, rested on two related sets of beliefs. first, patients-and the legislators who acted to support them-believed the off-label therapies at issue were 2. ala. code§ 27-1-10.1 (2003);n.j.stat.ann. § 26:1a-36.9(b) (west2003); tenn. code ann.§ 56-7-2352 (2003). 2004] mandated coverage of experimental therapy 217 likely to be of significant medical benefit. 3 second, patients believed their health insurance covered reasonable health care costs for medically beneficial care.4 at least part of the support for the latter belief lies in the typical langu­ age of health insurance contracts specifying that the scope of coverage encom­ passes reasonable and necessary care. specifically limited health insurance, such as dental insurance, quite clearly would not create the legitimate expecta­ tion of more general coverage. the difficult question is whether any off-label therapy falls within the general scope language extending coverage to care that is reasonable and necessary. the first set of beliefs-beliefs about the likely benefit to be obtained from off-label therapy-is central to answering this question, because the argument that the care is reasonable and necessary rests on the likely benefit to be obtained from it. thus patients' beliefs-that care would be beneficial and thus covered-were crucial to the purpose of the statutes. but are these beliefs reasonable? if not, what conclusions should we draw about the statutory mandates? do the mandates merely bootstrap unrea­ sonable original expectations into a new set of expectations based in the statutes themselves? or, do the statutes reinforce expectations that were originally legitimate? the reasonableness of beliefs is a complex matter. objective reason­ ableness is linked to whether the beliefs are true or false. respect for persons as choosers and planners of their lives, however, must be based on the world as they see it, not as it objectively might appear from a detached perspective. 5 beliefs that are founded upon the best available evidence may eventually be discovered to be false. in addition, people may hold beliefs that happen to be true but that are accepted for remarkably irrational reasons. respecting autonomy requires respecting choices based upon beliefs that seemed well founded when the choice was made, even if the beliefs might later be rejected. conversely, respecting autonomy does not require honoring irrationally accepted expectations or expectations ba8ed on beliefs that are known to be false or that reasonably should be regarded as suspect. auton­ omy is reasoned choice, not unfounded choice. to the same effect is the con­ sequentialist concern that honoring expectations based upon beliefs reasonable people should know are false may create counter-productive incentives for un­ reasonable reliance. subjective reasonableness is thus more relevant to expectations than objective reasonableness. but what does subjective reason­ ableness demand in areas of life where people are likely to be unreasonable3. in the language of these legislatures. "denial ofpaymentforoff-label use can interrupt or effectively deny access to necessary and appropriate treatment for a person being treated for a life-threatening illness." ala. code§ 27-1-10.1(3) (2003); n.j. stat. ann.§ 26:1a-36.9(d) (west 2003); tenn. code ann.§ 56-7-2352(4) (2003). 4. the statute might simply have mandated the coverage. to say that the coverage is "legitimately expected" suggests that patients believe it will be forthcoming, and that these beliefs ought to be honored. using the language of expectations suggests that what people believe plays a role in justifying the coverage. 5. see thomas nagel, the view from nowhere (1986). 218 indiana health law review [vol. 1:213 areas.that are momentous, but difficult to understand and emotionally chal­ lenging? health care is clearly such an area. even leaving emotions aside, health care decisions often require significant scientific and technical expertise. medical care, especially complex care for diseases that are serious and diffi­ cult to treat, is a context in which expert advice appropriately looms ·large. patients' beliefs about the likely efficacy of care are more reasonable when they are based on the recommendations of recognized experts-for example, physicians in centers designated as comprehensive cancer centers by the national cancer institute (''ncf').6 in addition, health care is not an area where emotions can be left aside; patients with life-limiting illnesses are understandably frightened and vulner­ able. moreover, such patients may be in a state of mind in which their powers of independent understanding are not as fully operative as they might be in other circumstances, such as understanding architectural advice in home­ building. in facing serious illness, patients struggle to understand difficult scientific concepts and understandably rely on expert advice. a patient's belief that therapy is likely to be safe and effective, when reached after consultation with a reasonable expert, is thus subjectively reasonable. this is not to say that all expert advice is, in turn, reasonable. how, then, does a judgment about the reasonableness of experts' beliefs affect a judgment about the reasonableness of a patient's beliefs? one important factor regarding a patient's belief is the degree to which the experts' beliefs have scientific support. available evidence may range from promising results in a few treated patients-results that may be sugges­ tive but may also be limited to certain patients-to a weu-designed, random­ ized clinical trial.7 moreover, experts may be swayed by enthusiasm gener­ ated by genuinely promising results in the most recent patients treated. experts may also be affected by financial interests in the research they are conducting. 8 at a minimum, experts should be aware of the level of evidenti­ ary support for their claims and any potential for conflict of interest. they should also attempt to make these factors transparent to patients. 9 6. see nat'l cancer inst., the national cancer institute cancer centers program, at http://cis.nci.nih.gov/fact/t .. 2.:htm oast visited july 25, 2003) (describing this designation, including the requirement for rigorous peer review). 7. see executive comm. working group, medicare coverage advisory comm., recommendations for evaluating effectiveness (feb. 23, 2001), available at http://www.cms .hhs.gov/mcac/8b1-i9.asp (discussing different levels of evidentiary support) [hereinafter medicare coverage advisory comm.]. 8. see karine morin et al., managing conflicts of interest in the conduct of clinical trials, 287 jama 78 (2002) (discussing how conflicts of interest may affect the conduct of clinical trials). 9. the transparency model of informed consent has been explored and defended by howard brody. the basic idea is that the physician's reasoning should be made clear (transparent) to the patient as part of the process of informed consent. see howard brody, transparency: informed consent in primary care, 19 hastings center rep. 5 (1989). 2004] mandated coverage of experimental therapy 219 experts, however, may fail to explain these differences carefully. physicians have difficulty admitting and explaining uncertainty to patients.10 recent studies of patients' understanding of medical research indicate that roughly half do not even understand that they are participating in research. 11 when a physician describes therapy in terms of chances of cure or partial remission, the patient may easily misunderstand. for example, informed con­ sent forms for participation in clinical trials often begin with a statement that the trial is for the purpose of research but then continue to include treatment language: ''you will begin treatment on day one" and ''treatment will continue until your disease progresses," rather than ''your entry into the research will begin on day one," and ''your participation in the study will continue until your disease progresses." consent forms may include a schedule of evalua­ tion extending over many years or ''for life," when in fact the expected end­ point of the research is only a. few months of event-free survival. another factor confounding judgment of subjective reasonableness is how people frame information about risk. tversky, kahneman, and other · students of decision theory have demonstrated that the description of a decision problem affects choice. faced with the same gambles described differently, people do not consistently elect the. option with the maximum expected utility.12 that is, they do not behave rationally, if rationality is understood in terms of utility maximization. instead, they are risk averse when offered the option of an assured gain versus a lottery with a chance of no gain but a higher expected payoff vaiue. at the same time, people are risk acceptant when offered the parallel option of an assured loss versus a lottery with a chance of no loss but a higher expected negative payo:ff.13 psycho­ logically, people want to gain something but lose nothing; whether a decision is framed as a potential loss or a potential gain makes much of the difference in how they choose.14 tversky and k.ahneman further argue that these and other descriptive findings about how people make choices should be of interest to the normative theory of rational choice.15 tversky and others have demonstrated this phenomenon in health care in the context of the choice between surgery and radiation for lung cancer.16 arguably, then, experts 10. see jay ka1z, the silent world of doctor and pa'rmnt (1984). 11. nancy e. kass et al., trust: 11ae fragile foundation of contemporary biomedical research, in intervention andr.erbcrion 494-99 (ronald munson ed., wadsworth 6th ed. 2000). 12. daniel kahneman & amos tversky, choices, values, and frames, in choices, values, and frames 1-16 (daniel kahneman & amos tveisky eds., 2000). 13. id. 14./d. 15. /d. at 209-23. 16. b.j. mcneil, s.c. pauker, h.c. sox, jr., & a tversky, on the elicitation of preferences for alternative therapies, 306 new eng. j.med. 1259 (1982). surgery involves a chance of death during the actual therapy, unlike the alternative of radiation. /d. however, the overall survival data are better for surgery. id. patients were less likely to opt for surgery 220 indiana health law review [vol. 1:213 advising patients should be aware of these framing effects and should be discouraged from using them as a strategy to influence patients' choices.17 in sum, reliance on experts, by itself, does not undermine the reasonableness of patients' beliefs. however, for the reliance to be reasonable, experts should strive to be clear about evidentiary support and about their own possible conflicts of interest, and also should strive to not play upon known factors affecting patient misperceptions. although reinforcement likely starts with reliance on expert advice, as described above, general social reinforcement arguably also affects beliefs about medical care. for example, newspaper reports of promising new therapies, rumors that a "cure" is just around the comer, or anecdotal reports of success from neighbors or friends may all feed unrealistic expectations about what is likely or possible from medical research. it is difficult to disen­ tangle the respective influence of such reinforcement, much less determine whether reliance on it is reasonable. the simplest claim about reasonableness would be that the more authoritative the source of reinforcement, the more reasonable the belief. thus, scientific reporting in newspapers such as the new york times, information on reputable web sites such as that of the nci, official reports from government agencies, and reinforcement found in statutes, administrative regulations, and judicial decisions would be considered more authoritative than, for example, a neighbor's account of a supposedly promising new therapy. for this reason, the role of legal mandates in creating expectations about entitlement to medical care warrants particularly careful scrutiny. part five (v) below, however, argues that legislatures and courts have not been as careful as they should be about the expectations they have created. all of these factors affecting subjective reasonableness-the vulner­ ability of patients, the importance of framing effects, the role of experts, and social reinforcement-converge in the situation of a patient with life-limiting cancer. social policy and law pose additional complications in the case of cancer treatment. patient advocacy groups and feminist groups have pressed the sympathetic situations of patients with breast cancer through language that assumes therapeutic efficacy for interventions such as high-dose chemo­ therapy with stem cell support. in response, a number of states have adopted coverage mandates for patients in clinical trials of new modalities of cancer if the choice of therapy was posed in terms of risks of mortality rather than in terms of chances of survival. /d. 17. other characteristic features of decision-making are also identified by work in the tversky and kahneman tradition. for example, the understanding of probability is not linear; people are far more influenced by the differences between 0 and 1% and between 99 and 100%, than they are by other differences of 1% on the probability scale. this feature may be especially important when people additionally confuse a certainty ("curej with a probability ("chance of remission") in medical decisions. see, e.g., daniel kahneman & amos tversky, prospect theory: an analysis of decision under risk, in choices, values, and frames, supra note 12, at 17-43. 2004] mandated coverage of experimental therapy 221 treatments (see part iv). but these coverage mandates may outstrip the justifications for them based solely on therapeutic efficacy (see part m. even more in the public eye, breast cancer patients (or their estates) have won high­ profile lawsuits challenging their insurers for denying coverage for high-dose chemotherapy with stem cell support (see part v). these cases foster the assumption that the care would be life-saving, and the concomitant conclusion that such care should be provided as a matter of entitlement. ii. high-dose chemotherapy with stem cell support for breast cancer: the clinical story a. the therapeutic strategy high-dose chemotherapy has been explored as a therapeutic option for a number of different types of cancer. this type of therapy has the advantage of potentially eradicating cancers that cannot be treated successfully with lower doses of chemotherapy.18 the disadvantages include cost-which may, depending on the patient's condition and complications of therapy, approxi­ mate $250,00019-and toxicity. high-dose chemotherapy, administered systemically, will kill all cells in the body that divide more rapidly than others, including bone marrow cells (the clinical term for destruction of bone marrow cells is "myoablative"). without functioning bone marrow, patients are unable to produce new blood cells and will die from infection, hemorrhage, or anemia. accordingly, patients receiving high-dose chemotherapy must be supported by are-infusion of cells that can recreate functioning bone marrow. during the period before bone marrow function returns, such patients are at risk of infection and other complications; the risk of death in the period of administration of high-dose chemotherapy and immediately thereafter is as high as ten percent, depending on the patient population. 20 if the patient donates the re-infused cells, the transplant is autologous. if a matched donor provides the cells, the transplant is allogeneic. the re-in­ fused cells may be harvested bone marrow cells or circulating stem cells. autologous transplants avoid graft-versus-host disease and have a lower rate of death associated with the immediate transplant procedure; however, autologous transplants may be less successful long term because of the 18. for a good description of high dose chemotherapy with stem cell support, see nat' i cancer inst., bone marrow transplation and peripheral blood stem cell transplantation: questions and answers, at http://cis.nci.nih.gov/fact/7 _ 41.htm (last visited feb. 5, 2004 ). 19. for a good discussion of the direct and indirect costs of bone marrow transplantation, see nat'lbone marrow transplant link, a resource guide for bone marrow/stem celltransplant(200l),athttp://www.nbmtlink.org/rg.asp#cost(lastvisitedmar.29,2004). 20. int'lmyelomafound., understanding autologous bone marrow and stem cell transplantation: here's what you should know 23, at http://myeloma.org/ images/content_pdf/bmt.pdf (last visited mar. 29, 2004). 222 indiana health law review [vol. 1:213 possibility the disease will not be fully eradicated.21 very recently, some transplant programs have been exploring lower-dose chemotherapeutic regimes coupled with allogeneic transplants. these programs are called mini­ transplants. higher-risk patients may be better able to tolerate the chemo­ therapeutic regimens involved. additionally, there is some hope that the mixed chimerism of the patient's own bone marrow, not fully ablated by the chemotherapy, together with the donor marrow, will create an immune reaction of independent therapeutic efficacy.22 in the 1980s, a number of transplant programs began exploring high­ dose chemotherapy with transplant support for the treatment of metastatic breast cancer. early reports suggested the therapy might be effective, al­ though these reports came from smaller (phase m trials that did not randomize patients and that did not report survival data over the long term. 23 the pro­ cedure came to be seen as life-saving, even miraculous. one court's opinion in a challenge by a patient to her insurer's denial of coverage was typical: in light of the medical testimony that hdc-abmt [high­ dose chemotherapy-autologous bone marrow transplant] is an effective form of therapy for breast cancer and that breast cancer patients who earnestly seek the treatment experience better prognoses than those who choose conventional treat­ ments, we find that the trial court did not err in fmding that hdc-abmt is not experimental or research in nature .... 24 other courts credited the therapy with lengthening life or improving the quality of life, despite very short durations of survival for patients.25 this enthusiasm, however, has been dashed by subsequent research. recent studies indicate no long-term or relapse-free survival benefit associated with high­ dose chemotherapy and stem cell support for breast cancer patients generally, although research is ongoing. 26 the nci web site designed for health care providers opines that "[i]n the absence of data suggesting.a benefit from high21. see generally id. (discussing autologous bone marrow transplants for multiple myeloma). 22. see, e.g., duke univ. health sys., about the procedure: bone ma"ow transplant & stem cell transplant program, at http://bmt.mc.duke.edulprocedure/t-minitransplant.asp (last visited mar. 29, 2004). 23. see, e.g., w.p. peters et al., high-dose combination alkylating agents with bone marrow support as initial treatment for metastatic breast cancer, 6 j. cunicaloncology 1368 (1988) (study at duke university). 24. taylor v. blue cross/blue shield of mich., 517 n.w;2d 864, 869-70 (mich. ct. app. 1994). 25. see, e.g., scalamandre v. oxford health plans, inc., 823 f. supp. 1050 (e.d.n.y 1993) (the patient had the procedure performed in september and october and then died the following january). 26. for a good overview, see astrid mayer & helena earl, whither high-dose chemo­ therapy in breast cancer? 3 breast cancer research 8 (2001). 2004] mandated coverage of experimental therapy 223 dose chemotherapy with stem cell support, this remains an area of clinical evaluation.'m toward this end. several clinical trials are ongoing. 28 the trials vary by chemotherapeutic regimen; some trials are of higher dose regimens and others of mini-transplants. these clinical trials have stringent criteria for entry, including patient age, disease stage, and prior treatment history; they are designed more for research than treatment purposes. nationwide, sophisticated patients seeking information about cancer treatment have increasingly turned to the internet patients who explore web sites of major cancer centers, however, will encounter significantly different views of the current status of myoablative therapy with stem cell support for breast cancer. an august 2003 survey of the web sites of the forty-two centers designated as comprehensive cancer centers by the national institutes of health ("nlll'') reveals that twenty-four of these web sites feature readily accessible, extensive, and clear descriptions of the difference between a clinical trial and treatment.29 on some web sites, however, the description of the difference is difficult to find30 or requires following a link to another site.31 some of these web sites even list high-dose chemotherapy with stem cell support as a possible treatment option for breast cancer. the lombardi cancer center at georgetown university features a "success story,. of a patient who survived breast cancer through a bone marrow transplant 32 the city of hope in los angeles boasts 5200 bone marrow transplants performed, the third largest number in the united states. 33 its site includes testimonials of two patients with advanced breast cancer. the web site description does 27. nat'l cancer inst., stage 111 b, 111 c, n. recurrent, and metastatic breast cancers: cytotoxic chemotherapy, available at http:/lwww.cancer.gov/cancerinfo/pdq/treatmentlbreast/ healthprofessionali#section_278 (last visited nov. 24, 2003) (citing da berry et al., high­ dose versus standard chemotherapy in metastatic breast cancer: comparison of cancer and leukemia group b trials with data from the autologous blood and marrow transplant registry, 20 j. cunical0ncology 743 (2002)). 28. nat'l cancer inst., clinical trials, available at www.cancer.gov/clinicaltrials/ (last visited mar. 16, 2004). the site is updated frequently to indicate the number of open trials of high-dose chemotherapy in which breast cancer patients are included. the listed trials vary by patient population, type of chemotherapy or radiation therapy, and therapeutic intensity. 29. data on file with the author and the indiana health law review. 30. see, e.g., the abramson cancer ctr. of univ. of pa., at www.oncolink.com (last visited nov. 24, 2003). 31. see, e.g., univ. of n.c. lineberger comprehensive cancerctr., at http://cancer.med .unc.edu/patient/default.asp (last visited jan. 1, 2004). 32. lombardi cancer ctr., success stories: surviving cancer, at http://lombardi .george town.edu/success/surviving.htm (last visited jan. 1, 2004). 33. city of hope, at http://www.cityofhope.org (last visited nov. 24, 2003) (providing many success stories of treating breast cancer patients with bone marrow transplantation). other comprehensive centers with web sites which suggest that bone marrow transplantation might be available as a treatment for breast cancer include the norris center at university of southern california, at http://ccnt.hsc.usc.edu/serviceslbreast_cancerltreatment.htm (last visited nov. 24, 2003), and the chao center at university of california-irvine, at http://www.ucihealth.com/ cancer/index.htm (last visited nov. 24. 2003). 224 indiana healtii law review [vol. 1:213 note that seventy-five percent of the cases treated at the city of hope involve leukemia or lymphoma (cancers in which the bone marrow itself is a cancer site), but lists breast cancer as an "other malignancy" treated. 34 the roswell park cancer institute at state university ofnew york-buffalo lists autologous bone marrow transplantation as a treatment option for "select" patients. 35 the m.d. anderson cancer center web site contains a careful description of clinical trials, their risks, and the possibility that insurance will not· pay for them.36 a separate location on the web site lists all of the clinical trials on­ going at the center, without the implication that clinical trial participation is indicated therapy. it also, however, lists myoablative therapy with stem cell support as a treatment option for advanced breast cancer. the fred hutchin­ son cancer research center in seattle contains a glowing description of a reunion of bone marrow transplant patients, which includes this text: malignant diseases such as breast cancer and others are now being treated in this way, since the same general principles of destroying malignant cells with mega doses of drugs and radiation are used. responses in breast cancer vary, but more time is necessary to evaluate the long-term results. some autoimmune diseases are also now the subjects of treatment with stem-cell transplants. 37 the mayo clinic, by contrast, does not include breast cancer as a solid tumor treated by bone marrow transplantation. 38 a fair inference from this survey is that patients accessing the web sites of these designated comprehensive cancer centers may be at best confused about whether myoablative chemotherapy with stem cell support is currently regarded as standard, effective treatment for advanced breast cancer. under­ standably, patients wanting the best medical care may conclude that because some centers offer this therapy as effective treatment, it is an option they should pursue and an option others should support as life-saving treatment for them. 34./d. 35. roswell park cancer inst., breast center, at http://www.roswellpark.org!document .asp?lid=723 (last visited nov. 24, 2003). 36. the univ. of tex. m.d. anderson cancerctr., athttp://www.mdanderson.org/ (last visited nov. 24, 2003). a number of other cancer centers also have designed their web sites to list clinical trials separately. 37. e.d. thomas & d. thomas, fred hutchinson cancer research ctr., the promising future of transplantation: expanded application of hematopoietic transplantation, at http://www.thcrc.orglvisitor/patient_experience/reunion.html (last visited nov. 24, 2003). 38. mayo clinic, at http://www.mayoclinic.org/bmarrowtransplant-rstl (last visited july 25,2003). 2004] mandated coverage of experimental therapy 225 b. insurance coverage for myoablative chemotherapy for breast cancer in the private market, health insurance coverage is established by con­ tract. insurance contracts typically provide coverage for medically indicated therapy, with enumerated exclusions and patient payment responsibilities. contract language will likely exclude therapy that is "experimental" or "investigational" in the judgment of the insurer. patients faced with coverage denials may challenge these judgments in court. because more than eighty­ five million patients are insured by its plans, blue cross and blue shield ("bc/bs") association has been a leader in assessing the evidence supporting medical practices.39 the bc/bs technology evaluation center (''tec"), established in 1985 and working in collaboration with kaiser permanente since 1993, provides evidence-based evaluations.40 tec does not list an evaluation of myoablative therapy with stem cell support for breast cancer, although it does for other cancers, such as multiple myeloma. in the case law, courts have expressed suspicion about technology assessment organizations and instead have relied on the testimony of treating oncologists. 41 medicare beneficiaries include both those qualifying for social security because they have worked the requisite forty quarter-years and those qualify­ ing because they are disabled. like bc/bs, medicare often plays a major role in coverage determinations because it covers over forty million patients and invests a high level of technical scrutiny in coverage decisions.42 under the medicare statute, one criterion for coverage determinations is whether the intervention is ''reasonable and necessary.'t43 as of this writing, cost is not listed as a factor in medicare regulations governing judgments of reason­ ableness and necessity,44 although discussion of this issue may resume with the public policy spotlight on the costs of the medicare program. coverage decisions are based on whether data supports the efficacy of therapy in the population over the age of sixty-five or in other patients eligible for medicare.45 a difficulty facing some coverage decisions is that there is little data about the safety or efficacy of some therapies in patients over the age of sixty-five. myoablative chemotherapy is an example because of its toxicity. some of the clinical trials now underway involving myoablative therapy for 39. blue cross blue shield ass'n, at http://www.bcbs.com/tecfmdex.html (last visited july 25, 2003). 40. id. 41. see,e.g.,adamsv.bluecross/blueshieldofmd., 757f.supp. 661 (d.md.1991); pirozzi v. blue cross-blue shield of va., 741 f. supp. 586 (e.d. va. 1990). 42. ctts. for medicare & medicaid servs., at http://www.cms.gov/medicare/ (last visited mar. 9, 2004) [hereinafter cms web site]. 43. 42 u.s.c. § 1395y(a)(l)(a) (2003). 44. for the regulatory definition of the scope ofmedicare covered services, see 42 c.f.r. § 402.3 (2003). 45. medicare coverage advisory comm., supra note 7. 226 indiana health law review [vol. 1:213 breast cancer specify an upper age limit of sixty and thus will provide data that is at best indirectly relevant to the majority of the medicare population.46 medicare coverage decisions may be made nationally or by local carriers if there is not a national coverage determination. 47 there is a national cover­ age determination that autologous stem cell transplantation is not covered for solid tumors, including breast cancer. the coverage decision was that there is insufficient evidence to show that high dose chemotherapy plus stem cell support is reasonable and necessary in the medicare population. 48 no national coverage determination has been issued for allogeneic transplants, but these transplants are not listed as covered services in the medicare population for patients with solid tumors.49 nor has there been a national coverage deter­ mination for mini-transplants. 5° ill. insurance coverage for patients participating in cunical trials clinical trials are designed to evaluate whether new medical interven­ tions are superior to standard patient management, including both treatment and diagnosis. the current canonical view is that clinical trials are not ethical without "equipoise:" there must be no good reason to believe that the innova­ tion to be tested is either better or worse than standard management of the patient. 51 without equipoise, the trial would be unethical because the patients 46. examples are the trial of allogeneic peripheral stem cell transplantation after anti­ thymocyte globulin, high-dose melphalan, and fludarabine in treating women with meta­ static adenocarcinoma of the breast, at http://clinicaltrials.8ov/ct/show/nct0007 4269?order =4 (last visited mar. 8, 2004), and the trial of chemotherapy and stem cell transplantation in treating patients with stage /lib breast cancer, at http://clinicaltrials.gov/ct/show/nctoooo 3042?order=7 (last visited mar. 8, 2004). 47. information about how medicare coverage determinations are made is available on the cms web site, at http://www.cms.gov/coverage/8a.asp (last visited mar. 8. 2004) (especially the june 4, 2002 report to congress available on the web site). 48. the full list of national coverage determinations can be found on the cms web site, at http://www.cms.gov/mcdlindex_iist.asp?iist_type=ncd (last visited mar. 8, 2004). 49. this information is from the cms web site, at http://www.cms.hhs.gov/ncdlsearch display.asp?ncd_id=45&ncd_ vrsn_num=4 (last visited july 25, 2003). a number oflocal carriers have made parallel determinations that stem cell transplants are not covered for solid tumors in patients in the medicare population. !d. these include the wisconsin physicians service insurance corporation (for wisconsin, illinois, michigan, and minnesota), palmetto government benefits (ohio and west virginia), blue cross and blue shield of nebraska (nebraska; also clarifies that "rninitransplants" are not covered for solid tumors), group health, n.y. (new york, queens), hgs administrators (pennsylvania), first coast service options (florida), and blue cross and blue shield of arkansas (arkansas, new mexico, oklahoma, northeastern and southern missouri, and louisiana). !d. 50. cms web site, at http://www.cms.gov/mcdlviewncd.asp?ncd_id=35-30.1&ncd_ version=5&show=all (last visited mar. 8, 2004). 51. benjamin freedman, equipoise and the ethics of clinical research, 317 new eng. j.med. 141 (1987). 2004] mandated coverage of experimental therapy 227 in one arm of the trial would be getting care already reasonably believed to be less good than care in one of the other arms of the trial. "equipoise," however, may be at best an unattainable ideal and at worst the basis of mis­ conceptions. although it is not ethical to design a clinical trial that withholds management of known value, many clinical trials approved today appear to comport uneasily with the idea of equipoise. fairly strong suspicions may be present among researchers that one arm of the trial is preferable to others, but unless the trial is stopped because of an adverse event or a significant result, it will continue. many trials include a placebo arm, albeit infrequently in cancer trials. even when there is a generally accepted standard therapy, placebo arms may be included if the risks to the patient are minimized and there is reason to believe there may be a large placebo effect or that the standard therapy carries disadvantages of its own. many trials also include a washout period in which a patient discontinues existing medications, again if the risks to patients are minimized. these concerns about equipoise have led at least two authors to argue that the ethics of research and the ethics of therapy should be detached, lest research be confused with the most effective, patient-centered therapy.52 randomized clinical trials are considered to give the best information about the efficacy of a given medical intervention. 53 in such clinical trials, patients are selected according to entry criteria designed to elicit reliable and valid scientific information about the intervention being studied. 54 too much variance in patient characteristics, for example, might obscure whether differences in patients or in clinical management explain differences in out­ comes. in the best clinical trials, patients are randomized among study arms to ensure that the variation being studied, and not variations among patients, is the relevant independent variable. 55 clinical trials of new therapeutic regimens are classified in "phases. "56 the primary goal of a phase i trial is evaluation of safety, safe dosage ranges, and side effects. therapeutic efficacy is only a secondary consideration. phase i trials of cancer chemotherapy regimens generally enroll a small number of patients, from twenty to eighty. patients are evaluated first at lower, possibly sub-therapeutic, dosages of the proposed regime. if patients at the lower dosage do not experience significant toxicities, patients are enrolled at higher dosage levels. dose escalation ceases when two patients experience significant toxicities. patients enrolled in phase i trials generally 52. franklin g. miller & howard brody, a critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials, 33 hastings center rep. 19 (2003), available at2003 wl 17821782. 53. ld. 54./d. 55. medicare coverage advisory comm., supra note 7. 56. see generally nat'l inst. health, cancertrials.gov, at www.clinicaltrials.gov (last visited jan. 1, 2004) (providing a general overview of clinical trials and discussing phases). 228 indiana health law review [vol. 1:213 have exhausted other available therapies; therefore, it is considered ethical to offer them the possibility of benefit even if the trial's main goal is to establish tolerated dosage levels. phase ll trials randomize patients between the investi­ gational regimen and a standard therapeutic regimen. enrolling larger num­ bers of patients, from 100 to 300, the trials are designed to see whether there are statistically significant differences between treatment arms and whether levels of toxicity are acceptable. phase ll trials focus on determining short­ term efficacy and safety of therapy. these trials have stopping rules under which they will be ended if reported toxicities are unacceptable or significant differences in efficacy become apparent. phase ill trials enroll a larger number of patients, typically from 1000 to 3000, and are undertaken only if phase ll trials suggest further study is warranted. phase m cancer trials typically require interim data analyses. they are stopped if there is clear evidence that one treatment arm is significantly preferable to others and, therefore, there is no longer clinical equipoise between the arms of the trial. phase n trials undertake continued collection of data after a new drug is given marketing approval based on data from earlier trials. the goal of phase n is to collect data on an ongoing basis as an approved therapy be­ comes employed in the general population of patients in need of treatment. distribution of a therapy into the general population of patients, outside the research context, may reveal quite different aspects of the therapy's risks and benefits. thus, the balance between scientific and therapeutic goals shifts with the phase of a clinical trial. for phase i trials, therapeutic goals are clearly secondary, although the investigational regimen would not be under study without some reason to believe it holds therapeutic promise. for phase n trials, therapeutic goals are undoubtedly primary, with the secondary aim being the ongoing monitoring of safety and efficacy. however, it is not at all clear that patients understand the differences between these types of clinical trials, much less the difference between research and therapy itself. the potential for confusion between therapy and research is so signifi­ cant that the confusion has been given a label among writers in bioethics: the "therapeutic misconception."57 if patients believe they are receiving what their physician regards as the "best treatment" for them, yet they are partici­ pating in a clinical trial in which they are randomized among treatment arms believed to be in equipoise, they fall under the therapeutic misconception. 58 the confusion between research and therapy is of course most significant in phase i trials, where the dosage level the patient receives may be set to evaluate something other than therapeutic efficacy. patients assigned to the initial dosage levels, for example, may receive less efficacious therapy, but 57. miller & brody, supra note 52. 58. ld. 2004] mandated coverage of experimental therapy 229 may also avoid more significant toxicities. 59 the misconception is also pre­ sent in phase iii trials, where patients may be randomized among treatment arms. in theory, phase iii trials are designed to be in equipoise; it would be unethical to expose a patient to the possibility of assignment to a treatment arm known to be less efficacious than other treatments. on the other hand, phase iii trials are undertaken against the background of suspicion that one arm will prove to be superior to the other(s). this background may be either inconclusive evidence that a new regimen is superior (e.g., evidence from a smaller phase ll trial), evidence that there are efficacy or toxicity problems with standard therapy, or other advantages to the therapy under investigation. phase iii trials are conducted in delicate balance between the need for data that are sufficiently significant to demonstrate the superiority of one treatment arm and the maintenance of sufficient clinical equipoise to permit continua­ tion of the study. the therapeutic misconception is fostered by the fact that patients with cancer face life-limiting illness. patients are in situations of significant personal, physical, and frequently even financial vulnerability. by the time patients contemplate entering a clinical trial, they may have already attempted and, in the language of medicine, "failed" other available treatment options. entry into a clinical trial may be an option of last resort. 60 one important study suggests that patients entering clinical trials do not adequately under­ stand that they are engaged in research or what being engaged in research actually means. 61 although ninety percent of patients in the study expressed overall satisfaction with the informed consent process, the majority (74%) did not understand that they were receiving non-standard treatment.62 many also did not understand the potential for additional risk presented by participation (63%), did not understand that the treatment was unproven (70%), did not understand the uncertainty of benefits to self (29% ), and did not realize that trials are done mainly to benefit future patients (25% ).63 in this study, increased knowledge was associated with college education, english as the only spoken language at home, the use of the united states nci consent form template, signing the consent form later than at initial discussion, presence of a nurse, and careful reading of the consent form. 64 other researchers have 59. /d. 60. see benjamin freedman, a response to a purported ethical difficulty with randomized clinical trials involving cancer patients, 3 j. cunical ethics 231 (1992) (discussing issues regarding patients with cancer in clinical trials); maria merritt, moral conflict in clinical trials, address before the pacific division meeting for the american philosophical association, seattle, wash. (mar. 2002) (on file with the author) (discussing tensions between clinical duties and scientific duties in phase i trials). 61. steven joffe et al., quality of informed consent in cancer clinical trials: a crosssectional survey, 358 lancet 9295 (2001). 62. ld. 63. ld. 64. ld. 230 indiana health law review [vol. 1:213 documented that patients from racial and ethnic minorities have particular difficulties understanding clinical trials.65 nonetheless, patients in many clinical trials, even phase i trials, pro­ bably do receive benefits. patients are monitored closely, perhaps more closely than they would be outside of the trial setting. clinical trials spon­ sored by the nih or by major cancer networks are designed on the basis of state-of-the-art knowledge about available options for patients. the treatment teams involved in such trials are likely to be highly experienced and may be better able to manage side effects and disease symptorns. finally. drugs or medical devices that have not yet received market clearance from the food and drug administration ("fda") will typi~ally be provided free of charge, or in some cases at the cost of production, which may be a significant cost savings.66 the advantages are well documented for cancer therapy involving children, where participation rates are far higher than the estimated three to five percent rate of participation for adults with cancer.67 the results demon. strate higher success rates in treating children with cancer and better develop­ ment of cancer therapies for children· compared to cancer treatment for adults.68 despite the fact that clinical trials involving patients with cancer typically offer experimental drugs without charge, patients (or their health insurers) generally are expected to pay all other charges of treatment received in the clinical trial. 69 patients are billed for the costs of administering the drug; the costs of diagnostic studies required to stage disease or assess disease progression; the costs of any hospitalizations, radiation therapy, or surgery; and the costs to treat any side effects or adverse reactions to therapy.70 the exceptions to these patient responsibilities are the costs of data collection or assessments required solely for the study itself and for monitoring therapy.71 patients entering clinical trials are advised that they will be responsible for costs, often without accurate estimates of what those costs might be because of expenses related to side effects, adverse reactions, or patients' responses to 65. elmer e. huerta & everly macario, communicating health r~k to ethnic groups: reaching hispanics as a case study, 25 j. nat'l cancerinst. monographs 23 (1999). see also l. ellington et al., decision making needs for randomized clinical trial participation among hispanics, 10 cancer control84 (2003) (arguing hispanic patients make decisions about participation based on the quality of the relationships they have with providers). 66. for a discussion of the costs of care for patients enrolled in clinical trials, see bruce h. fireman et al., cost of care for patients in cancer clinical trials, 92 j. nat'l cancer inst. 136 (2000). 67. jane e. brody, ferreting for facts in the realm of clinical trials, n.y. times, oct. 15,2002, atf7. 68. see, e.g., chan ka way, acute lymphoblastic leukemia 32 current probs. pedia1ric adou!scbnt realm care 40 (2002) •. 69. ftreman et al., supra note 66. 70. id. 71. ld. 2004] mandated coverage of experimental therapy 231 therapy may vary. patients are also advised that their insurers may not cover the costs of participating in clinical trials. 72 indeed, insurers frequently deny coverage of therapy deemed "experi­ mental" or "investigational."73 coverage can generally be negotiated for inter­ ventions that the patient would likely incur as part of disease management­ such as diagnostic studies needed to stage disease-whether or not the patient is in a clinical trial. in addition, coverage is generally provided for interven­ tions that are very similar to stl:}ndard therapy, such as modification of chemo­ therapy regimen. also, coverage is typically provided for management of adverse reactions to experimental treatment. expensive, novel interventions are most likely to be ones for which insurers have the incentive to delay decisions to allow coverage. a very high profile example of an intervention deemed experimental and hence, denied by many insurers was myoablative chemotherapy with stem cell support for breast cancer, where coverage was refused whether or not the patient was participating in a clinical trial. these refusals and legal challenges to them are discussed in part five (v) below. when patients' health insurance does not cover participation in clinical trials, both individual and collective problems may arguably result. on the individual level, patients may incur unforeseen and non-reimbursed costs for health care. they may be denied care that might actually prove beneficial to them. care studied in a clinical trial might also be offered off-study. refusal by insurers to pay for care in the study might create incentives for patients to seek care off-study. the pattern thus created would be counterproductive both for patients and for health care generally. patients may receive the care in a less structured setting in which they are not as well monitored. consequently, because the care is not formally characterized as investigational, it may come to be regarded as established therapy even though there is not yet sufficient data to support that conclusion. however, because the care is being delivered off-study and not as research, clinicians will be deterred from collecting or publishing systematic data about side effects and outcomes. collecting such data would require characterizing the delivery of the care as "research." moreover, patients provided care off-study are not randomized, and apparently promising outcomes may be only anecdotal results of confounding factors rather than of the care itself. the upshot may be the worst of both worlds: patients receive care erroneously styled as "treatment" under circumstances where scientifically useful evaluative data is not and cannot be collected. in the fall of 2000, medicare began covering routine costs for patients participating in specified clinical trials, as well as reasonable and necessary 72. see, e.g., nci, cancer facts, at http://cis.nci.nih.gov/fact/7 _ 41.htm oast visited feb. 5, 2004) (answering questions for patients contemplating bone marrow transplants). 73. see, e.g., nci, ci.lnical trials and insurance coveragea resource guide: summary, at http:/lwww .nci.nih.gov/clinicaltrials!understanding/insurance-coverage oast visited mar. 16, 2004). 232 indiana healm law review . [vol. 1:213 treatment for complications arising from participation in clinical trials.74 in extending this coverage, medicare acted on the recognition that there was often little reliable data as to whether new therapies are safe or effective in the medicare population. extending coverage to patients in clinical trials meeting specified scientific criteria would help to remedy that gap, thus enhancing coverage decisions generally. for purposes of this coverage, "routine costs" were defined to include all of the items and services otherwise available to medicare patients .. thus, routine costs would include hospitalization or costs for administration. of drugs, but not the drugs themselves, to the extent that medicare does not include drug coverage. services specified as routine costs are conventional care, care required to administer the experimental therapy or prevent complications, and reasonable and necessary care for the diagnosis or treatment of complications. routine costs exclude the costs of the test item (drug or medical device) itself. also excluded are services provided solely for data collection and analysis rather than the patient's clinical needs, such as additional scans for monitoring disease progression and efficacy of the test item but not used for clinical management. any item customarily provided free of charge for patients participating in the clinical trial (whether or not covered by medicare) is also excluded as a routine cost. for care to be covered, the purpose of the trial must be an evaluation of a service that falls within a medicare benefit category. trials must have therapeutic intent and not be designed to test toxicity or disease patho­ physiology exclusively. trials of therapeutic interventions must enroll only patients with a diagnosed disease. healthy volunteers may be included as controls in tests of diagnostic interventions. additional criteria that clinical trials qualifying for coverage must meet include: (1) the principal purpose of the trial must be to test whether the intervention potentially improves the participants' health outcomes; (2) the trial must be well-supported by available scientific and medical information or it must be intended to clarify or establish the health outcomes of interventions already in common clinical use; (3) the trial must not unjustifiably duplicate existing studies; (4) the trial design must be appropriate to answer the research question being asked in the trial; (5) the trial sponsor must be a credible organization or individual capable of execut­ ing the proposed trial successfully; (6) the trial must comply with federal regulations relating to the protection of human subjects; and (7) all aspects of the trial must be conducted according to the appropriate standards of scientific integrity. these criteria aim primarily to ensure the scientific merit of the study. the trial must be·designed to answer a research question, and duplication of results must be avoided. the criteria are also aimed at ensuring that the trial 74 .. the following discussion can be attributed to the medicare coverage document. see ctrs. for medicare & medicaid servs., national coverage determinations, at http://www .ems .hhs.gov/ncd/searchdisplay.asp?ncd_id=l&ncd_ vrsn_num=l (last visited july 28, 2003). 2004] mandated coverage of experimental therapy 233 meets core ethical standards for research: scientific integrity and the protec­ tion of human subjects. to be sure, the research must also have a therapeutic purpose; but therapeutic research that is not fitst rate science wt11 not qualify for coverage under the medicare standards. clinical trials sponsored by the nlll, the centers for disease control and prevention ("cdc"), the agency for healthcare research and quality ("ahrq"), the· healthcare financing administration ("hcfa," now ''cms"), the department ofdefense ("dod"), and the department of veterans affairs ("va") are deemed to automatically meet these additional criteria. trials conducted by centers or cooperative groups, such as the southwest oncology group ("swoo"), supported by the listed federal entities also automatically meet the additional criteria. trials conducted under an investigational new drug application reviewed by the fda likewise automatically qualify. other trials must certify·that they meet the medicare criteria and are enrolled in a medicare clinical trials registry. further development and review of these criteria is assigned to a multi-agency federal panel convened by the ahrq. these procedures are designed to ensure scientific quality and research integrity without the need for study-by­ study review. some insurers in the private market have adopted policies that parallel the approach taken by medicare. others continue to refuse to cover any therapy deemed experimental. state legislatures have entered the arena by enacting coverage mandates, but some of these mandates extend coverage far more broadly than the medicare criteria. these issues are the subject of part four(iv). n. statiitory approachestocovbragb within the past ten years, many states have mandated insurance coverage for some care treated as experimental under insurance plans. the majority of states now have coverage mandates for some off-label drug use.75 fewer states mandate coverage for certain patients participating in clinical 75. ala. code§ 27-1-10.1 (2003); ariz. rev. stat.§ 20-826(r) (2003); ark. code ann.§ 23-79-147(b) (michie 2003); cal. ins. code§ 10123.195(a)(2)(b) (deering 2003); conn. gen. stat. ann.§ 38a-492b (west 2003); ga. code ann.§ 33-24.59.11 (2003); 215 fil...comp.stat. 5/370-r(2003);1nd.codeann. § 27-8-20-7 (micbie2003);kan.stat.ann. § 40-2,168 (2002); la. rev. stat. ann.§ 22:230.4(a) (west 2003); me. rev. stat. ann. tit 24, § 2320-f (2003); md. code ann., ins.§ 15-804 (2003); mass. gen. laws ch. 175, § 47k (2003); mich. comp. laws§ 500,3406q (2003); minn. stat.§ 62q.525 (2002); miss. code ann.§ 83-9-8 (2003); nev.rev. stat.§ 689a.0404 (2003); n.h. rev. stat.ann. § 415:6g(1)(2002);n.j.stat.ann. § 17b:26-2.1g(west2003);n.c.gen.stat. §58-51-59 (2003); n.d. cent. code§ 26.1-36-06.1 (2003); ohio rev. code ann. § 1751.66(a) (1\n.derson 2002); okla. stat. tit 63, § 1-2604 (2002); or. rev. stat.§ 743.697(1) (2001); r.i. gen. laws § 27-55-2(a) (2002); s.c; code ann. § 38-71-275(a) (law. co-op. 2002); s.d. codified laws§ 58-17-101 (micbie2003); tenn. code ann.§ 56-7-2352(2003);tex.ins. code ann. § 21.53m (vernon 2003); va. code ann. § 38.2-3407.5(a) (michie 2003). 234 indiana health law review [vol. 1:213 trials. 76 as state law governing insurance, these mandates are preempted by the employee retirement income security act (''erisa") for employee welfare plans not deemed to be insurance; ·thus, state mandates do not extend to employers who self-insure their health plans.77 some employers nonethe­ less may follow state mandates voluntarily. as the descriptions below indi­ cate, however, the mandates vary in the scientific basis they require. the more indiscriminate mandates .arguably exacerbate the confusion between research and treatment. these mandates may lead patients to demand care that they. believe is needed treatment, even though it may not be beneficial, supported by evidence, or come under policy language covering "reasonable and necessary" care. a. coverage mandates for off-label drug use fda approval of new drugs for marketing includes labeling with indication, dosage, and patient population. labeling information is based on data supporting safety and efficacy of the drug for the indication in the patient population. 78 once a drug is marketed, physicians are legally permitted to prescribe it for different patient populations, at different dosages, or for new indications. in such situations, the drug is used "off-label." drugs used to treat cancer are frequently employed in off-label fashion.79 this practice is reasonable because cancer treatment evolves rapidly, and a drug initially found effective against one tumor type might also have promise against another. the alternative would be to require fda approval for each new indication, a cumbersome and time-consuming process that would introduce substantial delays. on the other hand; indiscriminate off-label use risks subjecting patients to highly toxic therapy that has not undergone rigorous 76. ariz. rev. stat. ann.§§ 20-826.01(a)(6),(7) (2003); cal. ins. code§ 10145.4(a) (2003); conn. gen~ stat. ann. § 38a-504a (west 2003); ga. code ann. § 33-24-59.l(a)(2) (2003); 2151il. comp.stat.ann. 5/356-y(c)(2) (2003); la. rev. stat. ann.§ 22.230.4(e)(2) (west 2003); me. rev. stat. ann. tit. 24-a, § 4310(l)(a) (2003); md. code ann., ins.§ 15827(e)(l)(2003);mass.oen.lawsann.ch.175,§110l(c)(2),(4)(west2003);mich.comp. laws§550.1929(7)(west2003);mo.ann.stat.§376.429(1)(west2003);nev.rev.stat. ann. 689a.04033 (michie 2003); n.h. rev. stat. ann.§ 415:18-l(ll) (2003); n.m. stat. ann. § 59a-2243(a) (michie 2003); n.c. gen. stat. § 58-3-255(a)(l) (2003); vt. stat. ann. tit. 8, § 4088b(a)(3) (2003); va. code ann. § 38.2-3418.8(d) (michie 2003). 77. 29 u.s.c .. § 1144 (2003). 78. seefood&drugadmin.,guidanceforlndustry:cunicalstudiessectionof labeling for prescription drugs and biologics-content and format (may 2001 draft), available at http://www.fdagov/cder/guidance/1890dft.pdf 79. nat'l cancer inst., understanding the approval process for new cancer drugs: q&a: off-label drugs, at www.cancer.gov/clinicaltrialslunderstandinglapproval-process-for-cancer­ drugslpage5 (last visited july 16, 2003). for a policy evaluating reimbwsement on the basis of each type of use, see, e.g., the montana blue cross/blue shield web site, at http://mtl-bcbs. bcbsmt.comlbsd/medicalpolicy .nsf/policiesbytitleview?open view&count=300 (last visited feb. 7,2004). 2004] mandated coverage of experimental therapy 235 scientific evaluation. thus, the nci both recognizes and urges caution in off­ label use. 80 it is estimated that at least half of all cancer patients receive some off-label treatment.81 estimates of off-label use are higher for children, because drugs are frequently approved for adults without having been tested in children. 82 more than thirty states currently mandate at least some coverage for off­ label uses of drugs.83 some states apply the mandate to off-label use in cancer treatment only, 84 while others apply the mandate generally. 85 still others apply the mandate only to drugs used in treating life-threatening or chronic and seriously debilitating conditions. 86 these mandates typically leave other coverage limitations undisturbed, such as deductibles and co-payments or restrictions on the use of non-formulary drugs. 87 80. nat'l cancer inst., supra note 79. 81. t. laetz & g. silberman, reimbursement policies constrain the practice of oncology, 266 jama 2996 (1991). 82. sharon conroy et al., unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children, 14 annals oncology 42 (2003). 83. nat'l cancer inst., understanding the approval process for new cancer drugs: summary,atwww.cancer.gov/clinicaltrials/understandinglapproval-process-for-cancer-drugs/ pages#anchor-wha-15227 (last visited july 18, 2003) (indicating that thirty-nine states have such coverage requirements, by statute, administrative regulation, or non-legislative agreement). however, this count may be an overestimation. several listed states provide for review of coverage denials but do not appear to mandate coverage for off-label drugs. one listed state, kentucky, has repealed its mandate. ky. rev. stat. ann.§ 304.17a-137 (repealed 2002). also, louisiana covers off-label uses only within clinical trials. la. rev. stat. ann. § 22:230.4(a) (west 2003). thirty states currently have statutory mandates for coverage of at least some off label uses. see supra note 75. 84. ariz. rev. stat.§ 20-826(r) (2003); ark. code ann.§ 23-79-147(b) (michie 2003); conn. gen. stat. ann.§ 38a-492b (west 2003); 2151i.l. comp. stat. 5/370-r (2003); kan. stat. ann. § 40-2,168 (2002); me. rev. stat. ann. tit. 24, § 2320-f (west 2003); minn. stat. § 62q.525 (2002); miss. code ann. § 83·9-8 (2003); nev. rev. stat. § 689a.0404(2003);n.c.gen. stat.§ 58-51-59 (2003); okla. stat. tit. 63, § 1-2604(2002); r.i. gen. laws§ 27-55-2(a) (2002); s.c. code ann.§ 38-71-275(a) (law. co-op. 2002); tenn. code ann.§ 56-7-2352 (2003); va. code ann.§ 38.2-3407.5(a) (michie 2003). 85. au.. code§ 27-1-10.1 (2003); ind. code ann.§ 27-8-20-7 (michie 2003); md. code ann., ins. § 15-804 (2003); mass. gen. laws ch. 175, § 47k (2003); n.h. rev. stat. ann.§ 415:6-g(l) (2002); n.j. stat. ann.§ 17b:26-2.1g (west 2003); n.d. cent. code, § 26.1-36-06.1 (2003); omorev.codeann. § 1751.66(a) (anderson2002); or. rev. stat. § 743.697(1) (2001). 86. cal. ins. code § 10123.195(a)(2)(b) (l>eering 2003); mich. comp. laws § 500.3406q (2003); tex. ins. code ann. § 21.53m (vernon 2003). cf. s.d. codified laws § 58-17-101 (michie 2003) (including limit only to cancer and life-threatening conditions). 87. arlz. rev. stat. § 20-826(r) (2003); cal. ins. code § 10123.195(h) (deering 2003); me. rev. stat. ann. tit. 24, § 2320-f(2)(e) (west 2003); n.h. rev. stat. ann. § 415:6-g(3) (2002); ohio rev. code ann.§ 1751.66(0)(4) (anderson 2002); r.i. gen. laws § 27-55-2(d) (2002). 236 indiana health law review [vol. 1:213 many states require at least some verification that use of the drug has been scientifically validated. 88 recognized validation methods include drug compendia such as the united states pharmacopeia drug information, the american medical association drug evaluations, or the american hospital formulary service drug information; or publications in the peer-reviewed literature. 89 these statutes provide patients with assurance that coverage will not be denied for beneficial treatment merely because sufficient evidence of safety and efficacy has not been provided to the fda to authorize changes in the drug's labeling. to the extent validation in the scientific literature is required, coverage is limited to therapy that has been evaluated for safety and efficacy. on the other hand, if the quality of scientific evidence is low, the mandates open the door to coverage for therapy of uncertain efficacy. the quality of scientific evidence required in the mandates varies significantly. some states require only a single peer-reviewed article, without further discussion of the required strength of the scientific evidence. in theory, the article could be a case report of the drug's use in one patient or in 88. the arizona statute has perhaps the most complete explanation of what might be considered scientific validation. in addition to medical reference compendia, arizona will recognize data if: (a) at least two articles from major peer reviewed professional medical journals have recognized, based on scientific or medical criteria, the drug's safety and effectiveness for treatment of the indication for which the drug has been pre­ scribed; (b) no article from a major peer reviewed professional medical journal has concluded, based on scientific or medical criteria, that the drug is unsafe or ineffective or that the drug's safety and effectiveness cannot be determined for the treatment of the indication for which the drug has been prescribed; [and] (c) the literature meets the uniform requirements for manuscripts sub­ mitted to biomedical journals established by the international committee of medical journal editors or is published in a journal specified by the united states department of health and human services as acceptable peer reviewed medical literature pursuant to section 186(t)(2)(b) of the social security act, 42 u.s.c. § 186(t)(2)(b) (2003). ariz. rev. stat. § 20-826(s)(2) (2003). other states require validation in at least two peer-reviewed articles. miss. code ann. § 83-9-8 (2003); nev. rev. stat. 689a.0404 (2003); s.c. code ann. § 38-71-275(c)(3) (law. co-op. 2002). some states, however, require as little as validation in one peer-reviewed article. ind. code ann.§ 27-8-20-7 (michie 2003); n.j. rev. stat.§ l7b:26-2.1g (2003). yet others refer generally to the "medical literature," without specifying numbers of articles or size of studies. mass. ann. laws ch. 175, § 47k (law. co-op. 2003); tenn. code ann. § 567-2352(c)(1) (2003). oregon requires the "majority" of the medical literature. or. rev. stat. § 743.697(1)(b) (2001). virginia notes specifically that "peer-reviewedmedicalliterature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier." va. code ann. § 38.23407.5(c) (michie 2003). even in the peer-reviewed literature, studies may vary importantly in the quality of the evidence they provide for a given therapeutic intervention. some publications may consist of single case reports or case series with historical controls, thought to be evidence of lesser quality than randomized clinical trials. see medicare coverage advisory comm., supra note 7. 89. see, e.g., conn. gen. stat. ann. § 38a-492b (west 2003). 2004] mandated coverage of experimental therapy 237 a small series of patients. moreover, blanket coverage mandates do not encourage systematic collection of further scientific data about the efficacy of therapy, although rigorous studies may take place in the clinical context. two solutions to these difficulties might be suggested. the first is to limit these coverage mandates to off-label uses that have reached sufficient scientific validation to appear in one of the recognized pharmaceutical com­ pendia. a second possibility, designed especially to gather good scientific evidence of therapeutic safety and efficacy, would be to cover off-label uses in appropriately-designed clinical trials, as illustrated by many of the clinical trials involving children with cancer. b. coverage mandates for participation in clinical trials since 1998, seventeen states have enacted statutes extending coverage mandates for cancer patients in at least some clinical trials. 90 despite the growth of such statutes, only one law review has regarded the development as a "note" -worthy innovation in state law. 91 even law reviews in connecticut, the home of much of the insurance industry, left the development un­ remarked. one early article, published before the movement towards such statutes gathered full steam, argued for limited coverage of patients participat­ ing in trials meeting certain standards of clinical integrity, scientific integrity, and fiscal soundness.92 this discussion saw the primary purpose of such coverage as a response to patients' desires for last chance therapy, and the secondary purpose as the development of better data about new therapies. the statutory coverage mandates actually enacted vary in important respects with regard to patients covered, type of clinical trial, costs covered, mechanism of operation, and apparent rationale. georgia's statute, the very first, only covers participation in clinical trials for children diagnosed with cancer.93 most other statutes are limited to patients who have been diagnosed with cancer and meet the qualifications for participating in the trial.94 nevada has also extended the mandate to patients enrolled in clinical trials for treatment of chronic fatigue syndrome.95 mandates in maine, maryland, new hampshire, and north carolina extend even more broadly ·to patients in clinical trials for any life-threatening condition. 96 90. see statutes cited, supra note 76. 91. lesley c. murphy, health and welfare: mandatory health insurance coverage for cancer clinical trials, 33 mcgeorgel. rev. 314,314-22 (2002). 92. mary ader, investigational treatments: coverage, controversy, and consensus, 5 ann. healthl. 45,45-60 (1996). 93. ga. code ann. § 33-24-59.1(a)(2) (2003). 94. see, e.g., cal. ins. code§ 10145.4(a) (west 2003). 95. nev. rev. stat. ann. 689a04033 (michie 2003). 96. see me. rev. stat. ann. tit. 24-a, § 4310(1)(a) (2003); mo. code ann., ins.§ 15827(e)(1)(ii) (2003); n.h. rev. stat. ann. § 415:18-l(ii) (2003); n.c. gen. stat. § 58-3255(a)(l) (2003). 238 indiana health law review [vol. 1:213 states have different limits on the phases of clinical trials covered. covering all phases (phases i-n) are california, maryland, massachusetts (phase i only at an academic medical center or affiliated facility), new hampshire (phase i and ll on a case-by-case basis only), vermont (all phases limited to approved centers), and virginia (phase i on a case-by-case basis only).97 lllinois, louisiana, nevada, and new mexico only cover phases ll­ n.98 connecticut only covers participation in phase ill trials,99 while missouri covers phases ill and n.100 statutes covering phase i trials require insurers to pay for interventions that do not necessarily have the primary goal of treating the patient at hand. statutes limiting coverage to the later phases focus more directly on trials in which therapeutic goals are paramount. many, but not all, of these statutes also limit the mandate explicitly to trials with some anticipated benefit for the patient, although they formulate this requirement in different ways. some statutes require a determination that participation offers the possibility of clinical benefit to the patient. 101 other statutes specify that qualifying trials must have therapeutic intent and end points not defined exclusively to test toxicity.102 others require a reason to believe that the proposed treatment is at least as effective as, or better than, available treatment.103 louisiana covers trials with therapeutic or palliative intent for prevention or early detection of cancer. 104 in a statute in effect from 2000-2003, lllinois required that the care be both medically appropriate and that it not yet have been determined to be safe, effective, or otherwise medically appropriate or necessary.105 perhaps reflecting an error in drafting, missouri requires that "there must be equal to or superior, noninvestigational treatment alternatives and the available clinical or preclinical data must provide a reasonable expectation that the treatment will be superior to the 97. cal ins. code § 10145.4(a) (west 2003); md. code ann., ins. § 15-827(e)(1) (2003); mass. gen. laws ann. ch. 175, § 110l(c)(2), (4) (2003); n.h. rev. stat. ann.§ 415:18-1(11) (2003); vt. stat. ann. tit. 8, § 4088b(a)(3) (2003); va. code ann.§ 38.23418.8(d) (michie 2003). 98. 215 ill comp. stat. ann. 5/356-y(c)(2) (west 2003); la. rev. stat. ann. § 22.230.4(e)(2) (west 2003); nev. rev. stat. ann. 689a04033 (michie 2003); n.m. stat. ann. § 59a-22-43(a) (michie 2003); n.c. gen. stat. § 58-3-255(a)(1) (2003). 99. conn. gen. stat. ann.§ 38a-504a (west 2003). perhaps the assumption is that phase iv, post-marketing trials, will be covered in any event, so their addition is not necessary. 100. mo. ann. stat. § 376.429(1) (west 2003). 101. calins.code§ 10145.4(a)(west2003)(insured'sphysiciandetermines"meaning­ ful potential to benefit"). 102. id.; mass.gen.lawsann. ch.175, § 110l(c)(9)(west2003)(addsthattheremust be a reasonable expectation of a medical benefit commensurate with the risks of participation). 103. ariz. rev. stat. ann. §§ 20-826.01(a)(6)-(7) (west 2003); md. code ann., ins. §§ 15-827(e)(4)-(5) (2003); nev. rev. stat. ann. 689a04033.1(d)-(e) (michie 2003); n.h. rev. stat. ann. § ill(b) (2003); va. code ann. §§ 33.2-3418.8(g)(l)-(2) (2003). if investigational treatment did not meet this standard, would the clinical trial be ethical? 104. la. rev. stat. ann. §§ 22:230.4(e)(1)-(2) (west 2003). 105. 2151il. comp. stat. ann.§§ 5/356y(a), (c)(3) (repealed 01/0112003). illinois also limited the coverage mandate to $10,000 annually. id. § 5/356y(a). 2004] mandated coverage of experimental therapy 239 noninvestigational alternatives." 106 more clearly, maine requires "meaningful potential for significant clinical benefit."107 north carolina requires that participation in the trial be medically indicated and more preferable for the patient than standard care, although it is difficult to see how a trial would be ethical if participation in it were medically indicated because one of the options is already known to be better than standard care. 108 as additional protection for patients, some states' statutes add provisions about the qualifications of the physicians providing the care. arizona, louisiana, nevada, new hampshire, new mexico, and virginia all require that the care be within the scope of practice, experience, and training of the physicians involved. 109 massachusetts, missouri, and north carolina add that the physicians must treat a sufficient volume of patiepts in that area of medicine to maintain their expertise.uo illinois' repealed statute required that the patient's primary care physician, if any, be involved in coordinating the care. 111 massachusetts and new hampshire require that the patient give informed consent that meets current legal and ethical standards, 112 and nevada demands that the patient be informed of the procedure, alternative methods of treatment, and the risks associated with participation in the clinical trial. 113 in addition to implementing medical provider guidelines, states employ a number of methods to ensure that covered trials meet scientific standards. the ones of these that are most stringent parallel medicare's limit to trials approved by various federal agencies or the centers and cooperative groups they support. 114 maine limits the approving federal agencies to the depart­ ment of health and human services, the nlli, and nlli-approved cooperative groups or centers. 115 arizona adds trials approved by a panel of experts in 106. mo. ann. stat. § 376.429(2) (west 2003). 107. me. rev. stat. ann. tit. 24-a, § 4310(l)(c) (2003). 108. n.c. gen. stat. § 58-3-255(a)(l)(a) (2003). the exact language in the north carolina statute reads: "medically indicated and preferable for that patient compared to available non-investigational treatment alternatives and ... have clinical and preclinical data that show the trial will likely be more effective for that patient than available noninvestigational alternatives." !d. 109. ariz. rev. stat. ann. § 20-826.01(a)(5) (west 2003); la. rev. stat. ann. § 22:230.4(e)(5) (west 2003); nev. rev. stat. ann. 689a.04033.1(c) (michie 2003); n.h. rev. stat. ann. § 415:181(ill)(c) (2003); n.m. stat. ann. § 59a-22-43(a)(7) (michie 2003); va. code ann. § 38.2-3418.8(f) (michie 2003). 110. mass. gen.lawsann. ch. 175, § 110l(c)(3)(2003); mo. ann. stat.§ 376.429(2) (2003); n.c. gen. stat. § 58-3-255(a)(1)(c) (2003). 111. 215 ill. comp. stat. ann. § 5/356-y(c)(5) (repealed 2003). 112. mass. gen. laws ann. ch. 175, § 110l(c)(6) (west 2003); n.h. rev. stat. ann. § 415:18-l(vl) (2003). 113. nev. rev. stat. ann. 689a.04033.1(g) (michie 2003). 114. cal. ins. code § 10145.4(c) (west 2003) (including trials of uses of non­ experimental drugs); conn. gen. stat. § 38a-504b (2003); 215 ill. comp. stat. ann. § 5/356-y(c)(3) (repealed 2003); la. rev. stat. ann.§ 22:230.4(e)(3) (west 2003); nev. rev. stat. ann. 689a.04033, l(b) (michie 2003). 115. me. rev. stat. ann. tit. 24-a, § 4310(4) (west 2003). 240 indiana health law review [vol. 1:213 clinical research within academic health institutions in arizona.u6 maryland, massachusetts, missouri, new hampshire, and virginia add trials approved by institutional review boards of institutions with multiple project assurance agreements with the office of protection from research risks of the nci. 117 many states add the requirement that the trial receive institutional review board approval, required for protection of human subjects in research, despite the fact that this is already a requirement for any federally funded research. 118 like medicare, these state statutes typically mandate coverage for routine costs of patient care: services provided outside a clinical trial as standard care, services provided for drug administration, services provided for disease staging and appropriate clinical monitoring, and services provided to treat side-effects and complications.119 costs typically not covered are those that are associated with data collection and management, 120 and costs that arguably should be covered if the goal of the statute were to advance medical knowledge. another typical exclusion is non-clinical services, such as travel, housing, and companion expenses. 121 unapproved drugs or devices are not covered in arizona and california. 122 another common exclusion is any costs covered by the trial for other enrolled patients, so insurers are not billed for costs the trial is willing to fund for other patients. 123 some of the statutes limit costs to in-state care, 124 others to in-state care unless the care is only available out-of-state125 or out-of-state care is otherwise a covered benefit for standard 116. ariz. rev. stat. §§ 20-826.0l(a)(3)(f)-(g) (2003). 117. mo. code ann., ins. § 15-827(e)(2)(v) (2003); mass. gen. laws ann. ch. 175, §§ llol (c)(2), (4) (west 2003) (requiring that phase i trials be conducted at an academic medical center or affiliated facility by clinicians with staff privileges); mo. rev. stat. § 376.429.4(5) (2003) (statutory language requiring "appropriate assurance" rather than "multiple project assurance"); n.h. rev. stat. ann. § 415:18-l(ill)(a)(5) (2003); va. code ann. § 38.2-3418.8(e)(5) (michie 2003). 118. ariz. rev. stat.§ 20-826.0l(a)(4) (2003); la. rev. stat. ann.§ 22:230.4(e)(4) (west 2003); n.m. stat. ann. § 59a-22-43(a)(6) (michie 2003). 119. cal. ins. code§ 10145.4(b)(l) (west 2003). 120. ariz. rev. stat.§ 20-826.01(g)(5)(d) (2003); cal. ins. code§ 10145.4(b)(2)(c) (west 2003); la. rev. stat. ann. § 22:230.4(a)(10)(b) (west 2003); me. rev. stat. ann. tit. 24-a, § 4310(2) (west 2003); md. code ann., ins.§ 15-827(a)(7)(ii)(3) (2003); mass. gen. laws ann. ch. 175, § 110l(a)(7) (west 2003); n.h. rev. stat. ann. § 415:18l(l)(h)(4) (2003); nev. rev. stat. ann. 689a.04033.4(g) (michie 2003); n.c. gen. stat.§ 58-3-255(d) (2003); va. code ann.§ 38.2-3418.8(c) (michie 2003). 121. ariz. rev. stat.§ 20-826.01(g)(5)(c) (2003); cal. ins. code§ l0145.4(b)(2)(b) (west 2003); la. rev. stat. ann.§ 22:230.4(a)(10)(a) (west 2003); nev. rev. stat. ann. 689a .04033.4(e)-(f) (michie 2003); n.c. gen. stat. § 58-3-255(d) (2003). 122. ariz. rev. stat. § 20-826.01(g)(5) (a)-(b) (west 2003) (excluding coverage on drugs or devices in phase i trials and any investigational drugs or devices); cal. ins. code § 10145.4(b)(2)(a) (west 2003). 123. cal. ins. code§ 10145.4(b)(2)(e) (west 2003). 124. ariz. rev. stat. § 20-826.0l(g)(5)(f) (2003); nev. rev. stat. § 689a.0404.1(f) (2003). 125. cal. ins. code§ 10145.4(d) (west 2003). 2004] mandated coverage of experimental therapy 241 treatment in the patient's insurance policy. 126 louisiana, maryland, and missouri have the additional requirement that any entity seeking coverage for clinical trials must maintain an up-to-date electronic post of the approved clinical trials, including the phase, approving entity, covered cancers, and estimated number of participants. 127 most of the statutes directly mandate benefits. however, the mandates may contain important exclusions. california, for example, excludes medi­ care supplementary insurance and champus, as well as insurance policies limited to certain types of benefits (for example, disability, vision only). 128 louisiana excludes plans paid for under title xvii (ssi for the aged and disabled) or title x (ssi for the blind) of the social security act.129 other statutes are structured as limits on what may be required as reimbursement for patients in clinical trials of cancer treatment; arizona and new mexico statutes function this way, and state explicitly that they provide only an administrative remedy, not a private right of action brought by a patient against an insurance corporation. 130 the michigan statute creates a fund to defray costs of patient participation, up to $5000 per facility in phase m or iv studies sponsored by the nih; 131 revenues for the fund come from fmes paid for violations of the insurance code, a strategy that avoids erisa preemption under the rationale of blue cross & blue shield v. travelers .132 most importantly, statutes differ in apparent rationale. no statute sets out a legislative statement of purpose, so the reasoning behind the statutes must be gleaned from their structure and substance. from the account given above, it would appear that the principal aim is likely therapeutic value, or at least the minimum requirement that the trial be likely to provide the patient with prospects at least as good as those offered by standard therapy. cost may have played a secondary role in the design of some statutes; for example, vermont regards its mandate as a pilot program at approved medical centers and requires an analysis of cost data to determine the financial effect on insurance premiums. 133 deference to approval by federal agencies would seem to assure scientific merit, but this approach may also have been moti­ vated by the effort to assure patients the best therapeutic options. limited attention has been given to other scientific goals. lllinois wanted covered trials to be conducted for the primary purpose of determining safety and 126. n.m. stat. ann.§ 59a-22-43(g) (michie 2003). 127. la. rev. stat. ann. § 22:230.4(f) (west 2003); md. code ann., ins. § 15827(g)(1) (2003); mo. rev. stat.§ 376.429(5) (2003). 128. cal. ins. code § 10145.4(f) (west 2003). 129. la. rev. stat. ann. § 22:230.4(c) (west 2003). 130. ariz. rev. stat.§ 20-826.0l(d) (2003); n.m. stat. ann.§ 594-22-43(e) (michie 2003). 131. mich. comp. laws § 550.1929(7) (2003). 132. n.y. state conference of blue cross & blue shield plans v. travelers ins. co., 514 u.s. 645 (1995). 133. vt. stat. ann. tit. 8, § 4088b(a)(4) (2003). 242 indiana health law review [vol. 1:213 efficacy, conducted at multiple centers, and aimed at the submission of peer reviewed publications.134 massachusetts incorporates the medicare require­ ment that the trial not unnecessarily duplicate existing studies, a criterion focusing on the scientific importance rather than the therapeutic efficacy of the trial. 135 the differentiation between trial phases for coverage purposes may also convey the message that not all clinical trials are equally therapeutic in intent. otherwise, statutes leave the general impression that their legislative aim is to provide patients with the therapeutic benefits of clinical trials. this justification may leave patients who do not fit the entry criteria for the trials feeling that they have been dealt with unjustly because they are not receiving treatment that the state apparently believes is beneficial for others. patients who do not meet strict entry criteria based on the science of the trials or who would like to participate in trials not covered by the statutes may wonder why they cannot take advantage of the therapy offered. indeed, the one published commentary on these statutes, the assessment of the california statute in the mcgeorge law review, illustrates this exact confusion about the rationale for the california mandate. 136 on the one hand, the commentary praises the statute for the possibility that by encouraging participation in clinical trials it will help to develop better information about cancer treatment. 137 on the other hand, it voices the concern that the statutory mandate will not cover therapy for a sufficient range of patients. 138 the commentary criticizes the require­ ment that the clinical trial must have "meaningful potential" to benefit the patient as vague and likely to exclude too many patients and praises the statute for increasing the likelihood that desperate patients (such as a woman with metastatic breast cancer seeking high-dose chemotherapy) will have access to coverage.139 the limits in most statutes to trials approved by federal agencies will probably keep the actual coverage mandates within the bounds of rigorous scientific studies. not all states impose these limits, however. it is important for legislatures to recognize that therapy alone cannot be the principal rationale for coverage, especially for patients participating in phase i trials. otherwise, statutory policy may contribute to the confusion held by many patients and members of the public that new therapies under investigation are the latest in established, beneficial care. this confusion has been especially apparent in the courts. 134. 215lll. comp. stat.§§ 5/356y(c)(3), (4), (6) (repealed 2003). 135. mass. gen. laws ch. 175, § 110l(c)(8) (2003). 136. murphy, supra note 91. 137. /d. at 321. 138. /d. at 322. 139. /d. at 321. 2004] mandated coverage of experimental therapy 243 v. high-dose chemotherapy in the courts the confusion between investigational therapies and beneficial treat­ ment has been manifested in the lawsuits brought by patients with breast cancer against insurance companies for denying coverage of high-dose chemo­ therapy. these lawsuits emerged in 1989, as initial encouraging reports appeared about the high-dose procedure and physicians began referring their patients to centers performing it. patients were successful in many cases in gaining preliminary injunctions ordering coverage of the procedure and sub­ sequently, summary judgment in their favor. only when insurance contracts listed the procedure explicitly as non-covered, and sometimes not even then, did the courts uphold coverage denials. almost all of the cases denying coverage involved a determination of whether the patient could reasonably expect the care to be covered under their insurance contracts.14° contracts create expectations, and courts interpreting contracts may have expectations about how similar contractual language is to be understood in other cases. in many of these cases, courts also determined that there had been sufficient testimony to support the efficacy of the therapy for the patient. decisions about the efficacy of therapy, for the patient before the court, should have been case-specific, but as more of the cases were decided, courts cited prior holdings to support the conclusion that the therapy was beneficial to patients, thus multiplying the decisions' effects. the fre­ quency of reported decisions diminished in the late 1990s, after reports questioning the evidentiary support for high-dose chemotherapy for breast cancer began to appear in the literature. nevertheless, patients continued to experience success in litigation, with rulings as late as 2002 holding that it was arbitrary and capricious for insurers to deny the coverage as investiga140. a few of the cases were state law contract cases. the six reported state cases resolv­ ing the issue on the merits (five mandating the coverage, one as late as 2002) occurred in arkansas, colorado, illinois, and michigan. am. inv. life ins. co. v. butler, 65 s.w.3d 472 (ark. ct. app. 2002); tepe v. rocky mtn. health & med. serv., 893 p.2d 1323 (colo. ct. app. 1994); o'rourke v. access health, inc., 668 n.e.2d 214 (ill. app. ct. 1996) (judgment for the insurer on plan language referring specifically to whether the federal office of technology assessment had recommended coverage); lubeznik v. healthchicago, inc., 644 n .e.2d 777 (ill. app. ct. 1994); mich. affiliated healthcare sys., inc. v. peoples life ins. co., no. 225067, 2001 mich. app. lexis 1805 (mich. ct. app. nov. 27, 2001); taylor v. blue cross-blue shield of mich., 517 n .w.2d 864 (mich. ct. app. 1994). an additional, recent state court deci­ sion resulted in a remand to the trial court for a decision on the merits. pacino v. med. mut. of ohio, inc., no. 78757,2001 ohio app. lexis 5749, at *8-9 (ohio ct. app. dec. 20, 2001) (re­ jecting trial court's finding that contract language was ambiguous; remanding for trial on the merits). by far, the majority of the cases were either brought in federal court or removed to federal court because they involved coverage determinations under erisa plans. in the cases under erisa, contract interpretation is a question of law for the court. coverage denials are reviewed under an arbitrary and capricious standard if discretion is reserved to the plan administrator; nearly all contemporary health insurance contracts reserve discretion in this way. whether a contract provision is ambiguous is a question of law for the court; ambiguities are resolved against the insurer that has interests in denying the care. 244 indiana health law review [vol. 1:213 tional. these rulings have appeared in many circuits, no doubt encouraging patients in the twin beliefs about their contractual coverage and the benefits of care. 141 in reaching their conclusions, courts have been signally impressed by the testimony of physicians recommending the care. courts reason that if physi­ cians recommend the care, it must be beneficial for their patients; therefore, it is irrational for insurers to deny coverage under an exception for care that is still under investigation and has not yet been demonstrated to be beneficial. in ruling against insurance plans, courts were especially impressed by their economic conflicts of interest, but almost never considered the possibility that physicians offering the procedure and testifying in its favor might have similar conflicts. 142 the leading case ordering coverage ofhdc/abmt, dozsa v. crum & forster insurance co., was brought in 1989 by a patient with multiple myeloma. 143 in that case, the plaintiff was granted a preliminary injunction ordering the therapy. 144 to grant the injunction, the court was required to find that the plaintiff was likely to prevail on the merits, that failure to grant the relief would result in irreparable injury, that the insurer had not shown countervailing injury, and that the public interest was benefited by the grant of the relief. 145 like subsequent courts relying on this decision, the court had little difficulty in finding that these standards were met. the language in the plaintiffs insurance contract stipulated that coverage would not be allowed unless the therapy was "neither educational nor experimental in nature nor provided primarily for research purposes."146 prudential, the insurer, con­ tended that: a procedure or course of treatment does not become accepted in the profession until it has been demonstrated through clini­ cal trials as being safe and effective for the condition. one of the best ways to determine the acceptance of such a procedure is through the published medical literature. cover­ age usually commences after there is clear consensus in peer reviewed medical literature. 147 141. for a description of how early decisions encouraged patients to go to court to seek coverage and how insurers responded by changing contract language, see goepel v. mail handlers benefit plan, no. 93-3711, 1993 u.s. dist. lexis 13346 (d.n.j. sept. 23, 1993), vacated by 36 f.3d 306 (3d cir. 1994). 142. see, e.g., dozsa v. crum & forster ins. co., 716 f. supp. 131, 139 (d.n.j. 1989). 143. ld. 144. ld. 145. ld. at 137. 146. ld. at 134 (emphasis in original). 147. ld. at 135. prudential had recently reviewed hdc/ abmt for myeloma and concluded it did not meet this standard because it was still "investigational." dozsa, 716 f. supp. at 135. at the time, there were two published papers in the literature, both published by a single physician, bart barlogie; no randomized clinical trials had been reported. ld. at 136. such case 2004] mandated coverage of experlmental therapy 245 the court concluded that prudential was applying a new standard for "experi­ mental," which the court labeled "investigational," in reasoning this way. the plaintiff's treating oncologist had referred him to johns hopkins, where he was found to be a suitable candidate for the therapy. the court reasoned that if respected physicians were recommending the treatment, it must not be "experimental" within the medical community: while it is true that a lack of peer reviewed medical literature might constitute some evidence of nonrecognition of the therapy throughout a doctor's profession, it is certainly not conclusive evidence. the four very talented expert witnesses in the present case were in disagreement on the question whether the literature concerning abmt treatment for multi­ ple myeloma constitutes backing of the treatment by a con­ sensus in peer reviewed medical literature and thus suppor­ tive of coverage even under defendants' mistaken reading of the plan language. it is unnecessary to decide that question one way or another because the undisputed testimony of dr. wingard and dr. davis establishes 1) as proposed for plain­ tiff the treatment was not educational or experimental in nature and was not to be provided primarily for research pur­ poses and 2) it is commonly and customarily recognized throughout dr. wingard's profession as appropriate treatment of multiple myeloma. 148 many subsequent decisions involving patients with breast cancer likewise credited the testimony of treating oncologists over appeals to evidence-based medicine, as described in what follows. the first reported decision ordering coverage of hdc/ ambt for a patient with breast cancer, pirozzi v. blue cross/blue shield, 149 was handed down in 1990. the plaintiffs plan excluded coverage for treatment that was an "experimental or clinical investigative procedure," but neither defmed these terms nor reserved judgment about their application for the plan administrator.15° construing what it regarded as ambiguous language against the insurer, the court credited the testimony of the treating oncologist that the procedure was pirozzi's best chance for meaningful survival. as in dozsa, the series are subject to notorious selection bias. medicare coverage advisory comm., supra note 7. for the medicare coverage advisory committee's decision memo on hdc/abmt for myeloma, seehttp://www.cms.hhs.gov/ncdr/memo.asp?id=10. for medicare's ultimate decision to approve coverage in 2000 for a subset of myeloma patients, after review of data from one randomized trial, see http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=3530.1&ncd_version=5&show--all (last visited feb. 8, 2004). 148. dozsa, 716 f. supp. at 138. 149. pirozzi v. blue cross/blue shield ofva., 741 f. supp. 586 (e.d. va. 1990). 150. /d. at 588. 246 indiana health law review [vol. 1:213 court reasoned that if the care was being used by major centers, it could not be investigational. 151 fu the next few years, decisions of this kind proliferated. fu 1991, district courts in connecticut, 152 maryland, 153 missouri, 154 and new y ork155 ordered coverage for hdci ambt. over succeeding years, they were joined by the second circuit, 156 the ninth circuit, 157 and other federal courts in alabama/58 the district of columbia, 159 tilinois, 160 fudiana, 161 missouri, 162 151. /d. at 591. 152. bucci v. blue cross/blue shield of conn., inc., 764 f. supp. 728 (d. conn. 1991). the bucci court followed dozsa and pirozzi in crediting the testimony of treating oncologists over the technology assessments of blue cross/blue shield. it also found "logical, scientifi­ cally," the idea that the therapy would prove successful. id. at 732. 153. adamsv.bluecross/blueshieldofmd.,lnc., 757f.supp.661 (d.md.1991). here the contract language read ''not generally acknowledged as accepted medical practice by the suitable medical specialty practicing in maryland, as decided by us." ld. at 663. maryland oncologists were typically referring patients to johns hopkins for the procedure. 154. white v. caterpillar, inc., 765 f. supp. 1418 (w.d. mo. 1991), aff'd, 985 f.2d 564 (8th cir. 1991). in white, the court credited the testimony of testifying oncologists over con­ tract language that required following the guidance of reports of the clinical efficacy assessment project of the american college ofphysicians and the council on scientific affairs of the american medical association. neither of these bodies had issued a determination that abmt should be regarded as effective therapy for breast cancer as established. /d. 155. kulakowski v. rochester hosp. serv. corp., 779 f. supp. 710 (w.d.n.y. 1991). here, the contract exclusion read: we will not provide benefits for any procedure or service which, in the sole judgment of the blue choice medical director, is experimental in nature. in addition, we will not provide benefits for medical treatments or procedures not proven to be safe and efficacious; nor will we provide benefits for ineffective or experimental surgical or medical treatments, or procedures, research studies or other experimental health care procedures under continued scientific testing and research with questions, in the sole judgment of the blue choice medical director, as to safety and efficacy. id. at 712 n.2. despite the contract language reserving judgment to the plan, the court con­ cluded that the insurer had applied a new and higher standard, credited the testimony of treating oncologists that the therapy was effective, and ruled that the coverage denial had been arbitrary and capricious. i d. at 717. the witness the court found most impressive was the oncologist from the transplant program to which kulakowski had been referred; his testimony reported the numbers of procedures he had performed and what he regarded as encouraging results from his series of patients. !d. at 713-14. the court cited white and pirozzi in its conclusion. !d. at 715. 156. zervos v. verizon, n.y., inc., 277 f.3d 635 (2d cir. 2002). 157. simkins v. nevadacare, inc., 229 f.3d 729 (9th cir. 2000). 158. calhoun v. complete health, inc., 860 f. supp. 1494 (s.d. ala. 1994). 159. wilson v. group hospitalization & med. servs., inc., 791 f. supp. 309 (d.d.c. 1992). 160. frendreis v. blue cross blue shield of mich., 873 f. supp. 1153 (n.d. lll. 1995); duckwitz v. gen. am. life ins. co., 812 f. supp. 864, 867 (n.d.lll. 1993) (holding hdc/abmt not an "organ transplant'' within the limits of plaintiff's policy). 161. smith v. office of civilian health & med. program of the unif. servs., 884 f. supp. 303 (s.d. ind. 1994), rev'd, 91 f.3d 905 (7th cir. 1996). 162. henderson v. bodine aluminum, inc., 70 f.3d 958, 960 (8th cir. 1995) (holding that it would violate the americans with disabilities act to cover effective therapy for some cancers but not effective hdc/abmt for plaintiff's breast cancer). 2004] mandated coverage of experimental therapy 247 new york, 163 north carolina, 164 south carolina, 165 tennessee, 166 virginia, 167 and washington. 168 additionally, the eleventh circuit ruled that "experimen­ tal" was ambiguous as a matter of law and reversed and remanded a grant of summary judgment for the insurer, requiring a trial on the merits. 169 these decisions typically followed dozsa in crediting the testimony of treating oncologists over insurance companies' contentions that the therapy had not been validated scientifically. courts seemed impressed by the fact that the treating oncologists had examined the patients, whereas the experts testifying for insurance companies typically had not examined the patients.170 the courts relied on the observation that major medical centers such as johns hopkins and duke were offering the procedure and that community oncolo­ gists were referring their patients to these centers. some courts explicitly borrowed the language typically used to state the standard of care in medical malpractice litigation-in the words of one court, whether the care is "gener­ ally acknowledged as accepted medical practice by the suitable medical specialty practicing in maryland."171 even when the language of the insurance contract granted unfettered discretion to plan administrators, some courts continued to find the denials arbitrary and capricious, in light of what they viewed as the patient's dire situation and the testimony of treating oncologists that the experimental treatment was the patient's only hope. cases in this vein were decided as late as 2001.172 sympathetic to patients, courts sometimes went to great lengths to read plan language against insurers. one particularly 163. whitneyv. empirebluecross&blue shield, 920f. supp. 477,480(s.d.n.y. 1996) (finding plaintiff benefited substantially from the treatment in february 1993, despite her death in july 1993; ordering coverage despite language reserving sole discretion to the insurer and a requirement of demonstrated benefit in the peer reviewed literature); scalamandre v. oxford health plans, inc., 823 f. supp. 1050, 1057 (e.d.n.y. 1993) (hdc/abmt "successfully extended [plaintiffs] life expectancy," from july 1991 to her death in january 1992); kekis v. blue cross & blue shield of utica-watertown, inc., 815 f. supp. 571 (n.d.n.y. 1993) (following kulakowski, dozsa). 164. hawkins v.mailhandlersbenefitplan, no.1:94cv6, 1994 u.s.dist. lexis 20671 (w.d.n.c. jun. 28, 1994). 165. gripkey v. mail handlers benefit plan, no. 3:94-378-0, 1994 u.s. dist. lexis 20619 (d.s.c. feb. 14, 1994). 166. mashburn v. mail handlers benefit plan, no. 3:94-0549, 1994 u.s. dist. lexis 19779 (m.d. tenn. aug. 4, 1994). 167. wheeler v. dynamic eng'g, inc., 850 f. supp. 459 (e.d. va. 1994); bailey v. blue cross/blue shield ofva., 866 f. supp. 277 (e.d. va. 1994). 168. bishop v. office of civilian health & med. programs of the unif. servs., 917 f. supp. 1469 (e.d. wash. 1996) (ordering coverage by champus). 169. dahl-eimers v. mutual of omaha life ins. co., 986 f.2d 1379 (11th cir. 1993). 170. see kulakowski v. rochester hosp. serv. corp., 779 f. supp. 710, 713 (w.d.n.y. 1991) ("dr. stankaitis had never seen or examined mrs. kulakowski, but based on a review of both her records and applicable medical literature, he opined that hdc/ abmt as proposed for her would be 'experimental' and, therefore, excluded from coverage under the contract."). 171. adams v. blue cross/blue shield of md., 757 f. supp. 661, 669 (d. md. 1991). 172. smith v. newport news shipbuilding health plan, inc., 148 f. supp. 2d 637 (e.d. va. 2001). 248 indiana health law review [vol. 1:213 unusual line of reasoning was a virginia court's determination that an insurance contract that excluded high dose chemotherapy "with" stem cell rescue could be read to cover the chemotherapy separately from the rescue.173 another court reasoned that the procedure was not a "transplant" within the ordinary understanding of the term.174 one of the decisions favoring the plaintiff was particularly noteworthy for confusing clinical trials with therapy. in dahl-eimers v. mutual of omaha, the eleventh circuit remanded a district court's ruling refusing a preliminary injunction to the plaintiff pending a determination of the plain­ tiff's likelihood of success on the merits. 175 the court held that the use of "experimental" in contract language was ambiguous as a matter oflaw.176 in dahl-eimers, the plaintiff sought to enter a phase iiii trial, and the consent form specifically stated that the patient might not benefit from participation.177 the district court judge had concluded that the procedure therefore came within the contract exclusion for "experimental" care.178 the eleventh cir­ cuit, however, concluded "experimental" was ambiguous and that the plaintiff was entitled to a trial on the merits to determine whether participation in the trial came within the contract. notably, the district court judge had vehe­ mently expressed concerns that the lack of federal funding for patients partici­ pating in clinical trials adversely affected patient care and the development of medicalknowledge.179 dahl-eimers may also be unique for the district court's observation of the possible conflict of interest on the part of oncologists seeking to enter patients into studies. 180 insurers responded to these decisions in part by changing contract language in an attempt to avoid rulings based on ambiguity. one strategy was to reserve discretion in coverage decisions to the plan administrator. another strategy was to define "experimental" as applying specifically to the context 173. bailey v. blue cross/blue shield ofva., 866 f. supp. 277 (e.d. va. 1994). the two therapies must be conjoined because the high dose chemotherapy oblates the patient's functioning bone marrow. /d. 174. calhoun v. complete health, inc., 860 f. supp. 1494 (s.d. ala. 1994). 175. see dahl-eimers v. mut. of omaha ufe ins. co., 986 f.2d 1379 (11th cir. 1993). 176. /d. at 1383-84. 177. dahl-eimers v. mut. of omaha life ins. co., 812 f. supp. 1193, 1196 (n.d. fla. 1992). 178. /d. at 1197-98. 179. in the words of the district court judge: it is unfortunate that adequate funding for clinical trials of drugs and treatments for catastrophic illnesses is not available from the federal government. but such funding is quite limited, and is thinly spread among thousands of competing programs involving literally hundreds of various illnesses and diseases. thought­ ful people need to ponder how this problem can be fairly resolved. /d. at 1198. 180. /d. at 1197. 2004] mandated coverage of experimental therapy 249 of a clinical trial.181 a third option was to base approval on determinations by various evaluating organizations, such as the clinical assessment project of the american college of physicians, the council of scientific affairs of the american medical association, 182 hcfa, 183 or the nih.184 insurance plans provided by the federal government for federal employees were particularly likely to be successful in referring coverage decisions to the standards of other federal agencies, such as medicare. federal plans also sometimes followed the medicare standards in specifically excluding breast cancer as an indication for which hdc/ abmt was covered. 185 where the exclusion was not explicit, however, courts ruled in favor of federally-employed plaintiffs as well. 186 despite the criticisms in scientific literature of hdc/abmt, courts continued to order coverage for breast cancer patients seeking high dose chemotherapy. the ninth circuit ruled in 2000 that a plaintiff could not reasonably have understood that an autologous bone marrow transplant was a "tissue transplant" within the exclusion language of her contract. 187 a federal district court in virginia granted a preliminary injunction for the plaintiff mandating the therapy so that she would not lose the window of opportunity for the procedure.188 in granting the injunction, the court dis­ counted the need for phase ill studies to show an advantage for high dose 181. lewisv. trustmarklns.co., 182f.3d908(4thcir.1999);wolfv.prudentiallns. co. of am., 50 f.3d 793 (10th cir. 1995); harris v. mut. of omaha co., no. ip92-1089-c, 1992 u.s. dist. lexis 21393 (s.d. ind. aug. 26, 1992). 182. see, e.g., uhrich v. caterpillar, inc., no. 93c5271, 1993 u.s. dist. lexis 16420 (n.d. ill. nov. 17, 1993). 183. see, e.g., bechtold v. physicians health plan ofn. ind., inc., 19 f.3d 322 (7th cir. 1994); fuja v. benefit trust life ins. co., 18 f.3d 1405 (7th cir. 1994). 184. lowery v. healthchicago, inc., no. 92c7657, 1994 u.s. dist. lexis 6380, at *3 (n.d. til. may 13, 1994). 185. hawkins v. mail handlers benefit plan, no. 1 :94cv6, 1994 u.s. dist. lexis 20671 (w.d.n.c. june28, 1994) (mail handlers plan); jaecks v. nat'iass'n of letter carriers health benefit plan, no. 93c6855, 1993 u.s. dist. lexis 16876 (n.d.lll. nov. 30, 1993); regerv. espy, 836 f. supp. 869 (n.d. ga. 1993); goepel v. mail handlers benefit plan, no. 93-3711, 1993 u.s. dist. lexis 13346 (d.n.j. sept. 23, 1993), vacated by 36 f.3d 306 (3d cir. 1994); dodd v. blue cross & blue shield ass'n, 835 f. supp. 888 (b.d. va. 1993); caudill v. blue cross-blue shield, no. 92-94-civ-7-f, 1992 u.s. dist. lexis 21448 (e.d.n.c. aug. 24, 1992). 186. see bishop v. office of civilian health & med. programs of the unif. servs., 917 f. supp. 1469 (e.d. wash. 1996); gripkey v. mail handlers benefit plan, no. 3:94-378-0, 1994 u.s. dist. lexis 20619(d.s.c. feb.14, 1994); wheelerv. dynamic eng' g., 850f. supp. 459 (e.d. va. 1994); mashburn v. mail handlers benefit plan, no. 3:94-0549, 1994 u.s. dist. lexis 19779 (m.d. tenn. aug. 4, 1994); smith v. office of civilian health & med. program of the unif. servs., 884f. supp. 303 (s.d. ind. l994);hawkins, 1994 u.s. dist. lexis 20671 (champus coverage). in the gripkey decision, the court concluded that the plaintiff had a reasonable likelihood of success on the merits because of the confused state of the decisions in other cases! 1994 u.s. dist. lexis 20619, at *10. 187. simkins v. nevadacare, inc., 229 f.3d 729 (9th cir. 2000). 188. smith v. newport news shipbuilding health plan, inc., 148 f. supp. 2d 637 (e.d. va. 2001). 250 indiana health law review [vol. 1:213 treatment over conventional chemotherapy; it found the testimony of treating oncologists sufficient. 189 in 2002, the second circuit ordered coverage of the therapy for a male patient with breast cancer, despite the patient's health plan's (empire health choice) reliance on recent technology assessments.190 also in 2002, a federal district court in michigan rejected an insurer's decision that high dose chemotherapy was not indicated for someone with the patient's stage and type of disease, although it was covered for other indica­ tions.191 finally, a state court in arkansas rejected an insurer's insistence on data showing that high dose chemotherapy was superior to standard therapy before extending coverage.192 no reported cases in 2003 appear to have ruled on the issue. to be sure, courts have not ruled uniformly in favor of plaintiffs seeking coverage for high dose chemotherapy. insurance companies have prevailed in some cases, especially when contract language was absolutely explicit about excluding the procedure for breast cancer. nonetheless, courts have been persuaded by the sympathetic situations of patients believing that court intervention was the patient's only hope. they have relied on the testimony of referring oncologists rather than on the published scientific literature. in so ruling, courts have reinforced the beliefs of patients that the care is both beneficial and covered. courts have thus encouraged patients to form ex­ pectations in reliance on experts without sufficient scrutiny to determine whether this reliance is reasonably placed. like legislatures, courts have not sufficiently distinguished therapeutic reasons from other moral reasons for providing care to patients when its efficacy is under investigation. vi. conclusion in mandating coverage for plaintiffs, courts sometimes noted public policy concerns. judges referred to the financing of health care in america as being in a state of crisis193 and to the difficult judgments involved in fund­ ing expensive new modalities of care.194 these are indeed difficult questions. it is important to try to determine whether new therapeutic modalities carry promise. funding patient participation in clinical trials is a major step in this direction. it is also important to ensure that new medical knowledge is developed in a manner that is fair to all patients, so that some groups (women, for example) are not left out. funding participation in clinical trials is like189. /d. at 652. 190. zervos v. verizon, n.y., inc., 277 f.3d 635 (2d cir. 2002). 191. reed v. wal-mart stores, inc., 197 f. supp. 2d 883 (b.d. mich. 2002). 192. am. inv. life ins. co. v. butler, 65 s.w.3d 472, 474 (ark. ct. app. 2002). 193. goepel v. mail handlers benefit plan, no. 93-3711, 1993 u.s. dist. lexis 13346 (d.n.j. sept. 23, 1993). 194. jaecks v. nat' i ass'n of letter carriers health benefit plan, no. 93c6855, 1993 u.s. dist. lexis 16876 (n.d. ill. nov. 30, 1993). 2004] mandated coverage of experimental therapy 251 wise important to this end. if it is beneficial for patients to participate in clinical trials, justice requires that access to the trials is fair. none of these reasons, however, support encouraging patients to believe they are entitled to experimental care as though it were already established therapy. unfor­ tunately, this is what the courts seem to have done in ruling in favor of patients seeking high dose chemotherapy for breast cancer. this is also what statutes mandating coverage for off-label drug use and participation in clinical trials may do if the mandates are not carefully limited. in the case of off.label drug use, mandates should be limited to uses that have been scientifically validated; some, but not all, of the statutory mandates incorporate this limit. in the case of participation in clinical trials, coverage should be limited to trials that are likely to yield scientifically helpful results. otherwise, the result may be further resort to courts by patients who have come to expect care as beneficial and believe, therefore, that the care is an entitlement. even if these expectations have been encouraged by the law, however, they are not legitimate and thus are not grounds for moral entitlement, because the beliefs on which they are grounded are not reasonable. health care reform in america: beyond ideology professor george j. annas* recipient of the mcdonald-merrill-ketcham memorial award for excellence in law and medicine march 19, 2008 editor's note the inspiration for the following keynote address was drawn from an arti­ cle authored by professor annas in 1995 which appeared in the new england journal of medicine.2 in that article, professor annas sought to explain the clinton healthcare plan's failure by analyzing the power and importance of the healthcare reform metaphors used in promoting the plan. in his remarks here, professor annas extends his analysis ofhealthcare related metaphors to those common in current health care reform parlance, theorizing that current efforts at healthcare reform have been unsuccessful, in part, because the metaphors used fail to frame the issues involved in a way that the american people can identify with. * professor annas is the edward r. utley professor and chair of the department of health law, bioethics & human rights at boston university school of public health and a professor at the boston university school of medicine and school oflaw. he is the co-founder of global lawyers and physicians, a transnational professional association oflawyers and phy­ sicians working together to promote human rights and health. he has a jd from harvard law school and an mph from harvard school ofpublic health. after graduating from law school, he clerked for justice john v. spalding of the massachusetts supreme judicial court and came to boston university in 1972 as the director of the center for law and health sciences at the law school. the author or editor of 16 books on health law and bioethics, including the rights of patients, and american bioethics, professor annas has been called "the father of patient rights," "the doyen of american medico-legal analysts," and a "national treasure." he is a fel­ low of the american association for the advancement of science, a member of the institute of medicine, co-chair of the american bar association's committee on health rights and bio­ ethics, and a member of the committee on human rights of the national academies. he has also held a variety of governmental regulatory posts, including vice chair of the massachusetts board ofregistration in medicine, chair of the massachusetts health facilities appeals board, and chair of the massachusetts organ transplant task force. copyright 2008 by george j. annas. 2. george j. annas, reframing the debate an health care reform by replacing our metaphors, 332 new eng. j. med. 745, 745-48 (1995). 442 indiana health law review [vol. 5:441 transcript of keynote address mr. annas: ernest hemingway wrote a complaining letter to faulkner after faulkner had reviewed the old man and the sea and gave it a poor re­ view. hemingway told faulkner that it wasn't right to criticize him. he wrote, "writers should stick together like doctors and lawyers and wolves." when asked about that he said, he didn't mean to demean the wolves. the wolves are great. these professions really stick together and support each other. he said he really admired that about doctors and lawyers. in the old days, all you had to know about being a physician was con­ tained in the boy scout law. i don't know if there are any old boy scouts here. if there are, you know a scout is: trustworthy, loyal, helpful, friendly, courteous, kind, obedient, cheerful, thrifty, brave, clean, and reverent, right? you have to be a boy scout to say that fast, but you don't have to be a boy scout to know the first six are what we want from our doctorsto be trustwor­ thy, loyal, helpful, friendly, courteous, and kind. and the last six are what our doctors what from usto be obedient, cheerful, thrifty, brave, clean, and rever­ ent. for good or evil, medicine, especially its technologically-driven nature and its increasing ability to identify and cure disease, has become much more com­ plicated, making it difficult for americans to even agree on how to talk about it. the last time the country got into a major discussion about healthcare was back in the early days of the clinton administration with the clinton health care plan. before that it was the medicare and medicaid discussion in the days of lyndon johnson. hopefully this year we will begin another national discus­ sion. we usually talk about healthcare every twenty years in this country, so we're doing it a little sooner than normal, but it won't come around again, un­ less the whole system collapses, for another ten or twenty years. so this is our big opportunity to try to get it right, and we should be thinking about what went wrong last time. the three major problems with healthcare have always beencost, qual­ ity, and access, specifically, containing costs, improving quality, and expanding access. that's not a revelation to anybody. we always talk about cost, quality, and access. most of the time lately, we've been talking exclusively about cost, and for good reason. current healthcare costs in america are over $2 trillion, $7500 a person, twice as much as most other countries spend, and ever increas­ ing at a rate usually at least double the annual consumer price index. so cost is a big deal, but quality is not irrelevant and certainly neither is access. they're all central issues, and i've argued before that you can't effectively deal with them separately. you have to deal with all three at the same time or any pro­ gress you make in one area is lost in another area. perhaps the only exception to this rule is eliminating or reducing harmful and unnecessary medical proce­ dures. 2008] health care reform fn america: beyond ideology 443 when hillary first and then bill clinton gave their two main speeches on healthcare introducing their healthcare plan, they both said that the plan was based on what they called six guiding stars: security, savings, quality, responsi­ bility, choice, and simplicity. and what you knew, if you took them seriously and if they took themselves seriously, is if these were the guides to flesh out their plan, then it was doomed to failure from the beginning. that's because these six are not only mutually inconsistent, they are also derived from totally different metaphors, and some of them, especially responsibility, are downright un-american. let's look at them quickly. first, security. i always thought security was strange in this context, but i was wrong and bill clinton was right. americans crave security. we really like security a lotespecially post-9/11 national se­ curity, and homeland security. you can go back to fdr and have social secu­ rity. so security was right. even though it adopts the military metaphor, as we'll talk about. as for savings, you're not going to get savings in expanding access to healthcare, so if s a little weird to talk about savings. maybe there is some waste in the system, and certainly administrative costs can be cut, but as a gen­ eral matter broadening access -at least in the absence of draconian rationing, will cost more money. quality is, like cost and access, one of the traditional big three. we always say quality when we talk about healthcare. we want quality healthcare. so there is nothing wrong with saying it again here, although you can't save money by improving quality. responsibility is, as i've already suggested, almost un-american. we don't take responsibility for anything in this country, either as a country or as individual citizens. we live as we please (that's the "american way oflife"), and expect our physicians to take care of us if our lifestyles lead to injury or disease. choice is good, even central to being an american. liberty is great, and americans love choice; although we'll have to ask, choice of what? finally, simplicity: simplicity is, i think, a cruel joke. whatever our cur­ rent system (or non-system as most analysts prefer to denote it) is, it is extraor­ dinarily complexas was the clinton plan. harry and louise, two characters created as spokespersons for the health insurance industry, starred in a series of commercials opposing the clinton plan -some of you may remember thesewith the catch phrase, "they choose, we lose." the clintons responded with a spoof about the harry and louise series. it was one of the funniest things i ever saw, but the clintons came quickly to believe that it could be counterproductive, and shut it down. i don't know if it's on y outube, but i've never seen it again. at one point in their harry and louise spoof, hillary says to bill, "you know, at page 27,655 ofyour health­ care plan, it says eventually we all die." to which bill responds, "there's got to be a better way." and in a way we all think that. we know we're going to die, but we don't confront it in this country. we deny death, and at some level 444 indiana health law review [vol. 5:441 expect american medicine to save us from it by coming up with a "medical miracle." sam donaldson said, as soon as he saw the clinton exchange, that they should get rid of it immediately because if you ever talk about death in the united states, that's the end of your campaign. in his viewand he may be rightpoliticians can't talk about death in the u.s. the other thing that happened, this was a coincidence, but i think is still relevant to our discussion. on the very day in september, 1994 that bill clin­ ton withdrew his healthcare plan from the u.s. senate, the first episode of er was aired in the united states. the program is still going on, and is the long­ est-lived medical series in u.s. television history. why is that? is it because, as newsweek says, that's "a health program that really works?" is it because it focuses on sex and violence? or is it because emergency care is the only care that americans have a legal right towhich i think is at the core of its popular­ ity (there are lots of other programs featuring sex and violence). americans really, really like knowing that they can get emergency care when they need it. they like at least a limited legal right to healthcare, a right to emergency care. no way you can take that away. it's been tried. it's very difficult even to close your emergency room department. americans really like the fact, as portrayed on the show, that whenever someone got to the emergency department, they were taken care of. they were taken care of based on what was wrong with them, not based on how much money they had or the insurance plan they had, what race they were, or what their occupation was. they were taken care of because they were sick or in­ jured and needed care. and i do believe that the overwhelming majority of americans believe that's the way it should be, that people should have a right to health care, not just a right to emergency care, and that we're struggling with a way to actualize that right without breaking the bank, and without interfering with choice. so that's a big deal, and i don't want you to forget that. americans be­ lieve in the right to emergency care. and that could be generalized, i think, to the right to healthcare, at least what we might call basic healthcare or decent health care. we have to figure out what that means, of course, and it's not easy. and that's where metaphors can help us, and are probably necessary. so we're going to talk about metaphors. the most famous metaphor in the last couple weeks in the united states has been the red phone. and what does that mean? what is it a metaphor for? it suggests that the next president will have to be able to answer an emergency call in the middle of the night and make a deci­ sion. but what does it stand for? is it experience? is it 9/11? what does that metaphor stand for? the point is that metaphors use something else to stand for a thing that it's not. so when we talk about healthcare in military terms, we use military images to displace or explain healthcare. most often we use metaphors as a mirror, as a way to see something and give us more information about what the thing is re­ ally like. my body is my house, for example, and i should maintain it and take 2008] health care reform in america: beyond ideology 445 care of it. but sometimes metaphors can be subversive; we can use it to un­ dermine reality. the essence of the person is the brain (therefore if we can maintain the brainin or out of the bodywe maintain the person, perhaps immortally. and sometimes they can be transformative; we use them to try to transform reality and make it into something different. the body is a complex of parts, like a jigsaw puzzle, so if one part is destroyed or diseased, we can replace it. metaphors are complicated things, and you can decide for yourself, as many americans are, what the red phone stands for, and how you relate to that, and how that relates to the candidates, and what we should think about that. but by discussing the red phone publicly, americans will also come to a consensus on what it "means." in health care, when we talk about emergencies, we talk about emergency care. when we talk about emergencies in the united states, we know it's much more complicated than that, especially since 9111 as we have adopted more and more national security metaphors which have even infected medicine and pub­ lic health. one of my favorite examples is the bird flu scare of two years ago (scientists tell us nothing's changed in two years. we're at exactly the same risk for a global pandemic of bird flu today as we were two years ago). two years ago when the government tried to get all americans extremely excited and fearful about bird flu, the president literally said he was ready to call out the army to barricade and quarantine offparts of the united states if a bird flu pandemic started here. one of the stupidest ideas ever, but nonetheless, it showed how his administration felt about the bird flu a national security problem that demanded military intervention. it turns out, americans are not afraid of chickens. i mean that literally. we're afraid oflots of things since 9/11, but you can't get americans excited about the flu or birds. on the other hand, something that's a lot less scary got americans half hysterical: sars. and you can ask yourself what's the differ­ ence between sars and the bird flu besides the birds that is. and it has something to do with where it came from although likely the bird flu would come from somewhere in asia as welland that it's mysterious, unknown and unfamiliar. we really didn't know what it was, or how it spread, and had no cures, and no treatments. at least we had some treatments for the flu. even though 40,000 americans die of the flu every year and no americans have ever died ofsars. so we get afraid of different things for different reasons, mostly having nothing to do with rationality or probabilities. and it helps us, i think, to try to figure out why we react to some emergencies, like a medical emer­ gency, with compassion and a belief that we should have a law about that everybody should have the right to emergency treatment. but for other treat­ ments, such as treatments for chronic diseases, the american public sees it, ap­ parently, through a totally different lens. of course, the scariest thing in the world is a lawyer with a contagious disease. andrew speaker, a tb patient, was, for a few days at least, the scariest person in the world. the frightening thing he did was take a plane to get mar­ ried in europe and then successfully evade the cdc which was publicly trying 446 indiana health law review [vol. 5:441 to track him down and quarantine him. he was the first sick person ever to be put on the anti-terrorist no-fly list. so we treated andrew speaker exactly like a bioterrorist. even though it turns out he was misdiagnosed, and didn't put any­ body at risk ever. nonetheless, he's still stared at. this guy has said he still can't really go out and walk around the community, even though he is not and never was contagious. the only person he would likely have ever infected is his fiancee, and obviously that's the last thing he really wanted to do. nonethe­ less, he's an example of how we can personalize and stigmatize and try to blame individuals for giant public health problems that we have done all-too­ little to resolve, and that they are victims of, not perpetrators of. speaker had nothing to do with the epidemic oftb around the world. the fact that he was a lawyer being pursued by physicians also makes this too good a story not to re­ count in a law-medicine lecture. all right, now let's look directly at metaphors in medicinefinally i'm sure you're thinking. probably the best work that's ever been done on meta­ phors in medicine was done by susan sontag in two of her books. illness as metaphor, published in 1977, is about her bout with breast cancer and her re­ alization, as a cancer patient, that cancer is used pervasively throughout society as a metaphor, and not a metaphor for good things either; and that it stigmatizes cancer patients by making them feel extremely ostracized and not part of the human race. secondly, there are lots of other metaphors she found out besides using cancer as a metaphor. medicine adopts lots of metaphors itself which have negative impacts on patients. especially she talks about the military me­ taphor, which we will talk about in a second. in illness as metaphor she also wrote about plague and epidemic meta­ phors, which she expected to recede as medicine became more adept. but with the rise of aids after her first book, she wrote another book, aids and its me­ taphors. it turned out actually, that hiv/aids metaphors were all plague re­ lated metaphors that stigmatized patients, tended to plague patients for their own disease, and tended to also adopt the military metaphor again. andrew speaker is a good example of an individual demonized by the plague metaphor. so i want to give susan sontag total credit for beginning this dialogue, at least in the public sphere. others have written about metaphors in medicine too, but i think she wrote the best books. the first metaphor she explains is the military metaphor, and you're all familiar with the military metaphor whether you've thought about its use or not. because we're always doing battle, we're always fighting disease. the disease invades the body and using our armamen­ taria, using our smart weapons, using everything that we can throw at it we try to defeat the enemy, and in the battle for life, it sometimes becomes unclear who the enemy is. sometimes the patient's body itself is seen as the battlefield. you can't obviously win the battle and lose the war by killing the patient, literally killing the patient (although we have the old joke, the operation was a suc­ cess, but the patient died). and it can also be unconditional warfare in the sense that you can be seen even as fighting good versus evil, fight to the death, if you will, and in those kind of fights, anything goes. literally anything goes, 2008] health care reform in america: beyond ideology 447 we follow shakespeare, desperate diseases require desperate remedies. and the metaphor gets used a lot in things like bone marrow transplants, where you have to literally kill the bone marrow in a patient and try to resurrect it. so again, sontag argues and other people have argued that military metaphors tend to make us over mobilize, tend to say there are no limits, to spend and do what­ ever's necessary for victory. the noted princeton economist, uwe reinhardt, has pointed out that med­ icine and the military are the only sectors in which we will pay 100% more for something that's 1% more effective. every other sector pays 1% more for 1% better, but in the military and in medicine we'll pay 100% more, probably even 1000% more for something that's a little bit better, because we are thinking about survival and life is "priceless." we've seen this most dramatically in some of the "new" cancer drugs that may not even prolong survival, but can keep a tumor from growing for a few months. those drugs produce revenues of literally billions of dollars right now. so the body is a battlefield, and the military metaphor tends let physicians to do things to patients that i would argue they shouldn't do. again, sontag thought that metaphor would go away by now, thought we'd be done with it by now. but we're not, at least not entirely. but its dominance has receded as we have latched on to a newer metaphor. after the clinton plan failed, the new metaphor in medicine, the prime metaphor, was the market metaphor. and it remains dominant. we don't have patients anymore, we have consumers; we don't have hospitals or specializations anymore; we have product lines; we en­ gage in advertising to gain market share in covered lives. we spend a lot of time in mergers and acquisitions, and corporations, both for-profit and not-for­ profit, tend to be much more interested in a healthy bottom line than a healthy population. the market metaphor has been very pervasive, and it feeds into lots of heavy-duty american values, like freedom (as in free market) and choice. the market metaphor is perfect for choice, even though in the harry and louise commercials, it was choice of doctor. that's what they were worried about. they're going to take away our choice of physicians. turns out americans re­ ally were worried about that. the choice the healthcare insurance market of­ fers, however, is the choice of health plans (at least for those who can afford the premiums), insurance plans, choice of insurance, and it does lead us to know that even on the national level we tend to use interchangeably the words "na­ tional healthcare" and "national health insurance." hopefully insurance will provide access to care, but not necessarily. those two things are different, and while there are many european countries that have national health insurance, there are also countries like england that have national care with no insurance at all. everybody just has access to care. they cut out the middle man. we can argue about that, but every dollar of expenses in healthcare, a little over $2 trillion annually and growing, is somebody' s dollar of income, and they will fight to retain it. the clintons found that out lots of times. 448 indiana health law review [vol. 5:441 well, is there another metaphor that we can use if these two tend to pro­ mote excess spending without providing universal coverage or access? i think there is. i suggested in 1995 that the ecological metaphor is necessary and that we should at least consider as an alternative. ecology has not been that strong a point for our country, though we see some possible shifts lately. ecologists think in terms of sustainability, and at least some public officials are now start­ ing to think about it. even in my own state of massachusetts with our new mandate program. therese murray, our speaker of the senate, just said two weeks ago, that massachusetts will have to make some fundamental changes to healthcare if our plan is going to be "sustainable." so she adopted sustainabil­ ity, and she's right. sustainability is a requirement to any meaningful health care reform. also, quality oflife, and quality ofthe environment are important concepts, more important, i think, than quantity of life or quantity of consump­ tion. natural and renewable are also important concepts. all of those elements of the environmental metaphor may lead us to think in new ways about health­ care. even to think about that horrible word in the united states, limits. we don't have to think about rationing right away, but there might be some limits to how much we should spend, how much medical treatment we should provide to individual patients. the health care system has been called lots of things by lots of people, but train wreck and shipwreck are the terms that are commonly used to describe the healthcare system. it's thought that we're not going to change it until it im­ plodes or collapses, until we experience a real national emergency. a few weeks ago policy expert lawrence brown wrote a very nice piece in the new england journal of medicine where he argued that we don't have two health­ care systems like we've always thought about, a public and a private one. we really have three healthcare systems, and he thinks that explains why the system has not imploded yet. and he may be right. he used another powerful meta­ phor, what we call the "safety net." we have the public systemmedicare, medicaid, va, the military hospitals -the private system, everybody else, and the safety net, the uncoordinated system of emergency departments, community health centers, and public health clinics. so we all have convinced ourselves that because the "safety net" exists, we really don't have to provide health in­ surance for the forty-seven million people without insurance, or better insur­ ance for the fifty million who are underinsuredthe safety net will take care of them. one of the people who commented on a presentation i gave in texas a couple months ago said to meand it's mostly true"well, how bad can it be, people are not dying on the streets. you don't see people dying on the streets." that's true. because we do havewe go back to where we started -we have a right, a legal right to emergency care. and when the people get to emergency departments, whether the ambulance brings them, the police bring them, or their relatives bring them, they get care. we do care for them, whether they have insurance or not. and is that highly-valued right to emergency care actu­ ally working against attempts to reform the healthcare system? 2008] health care reform in america: beyond ideology 449 maybe instead of looking at the healthcare system as a ship that needs stars, shinning or otherwise, to guide it, we should be looking at the ship itself. for the last twenty years i've argued that the american healthcare system has four major characteristics that we have to deal with in order to even talk about reform. working on this presentation has helped me to think that it may be more fruitful to argue that the american healthcare system itself is a metaphor, a metaphor for america. it reflects america, and it tells us about americans, about ourselves. we really exhibit all those characteristics ourselves and they reflect our country and its values. we're technologically driven. we love technology, and we always want to be early adopters of new technology. we're spending more money on re­ search for new medical technology, including new drugs and biologics, than all the other countries in the world put together. we're death denying; we abso­ lutely, totally will not talk about death. that's not going to happen to us right? we're individualistic. we already saw that. we want our choice. we are the rugged individualists, right? we're the most individualistic country in the world. and we're wasteful, and we don't care. the only one of these four i think is easy to deal witheasyis wastefulness. the market model with effi­ ciency could tend to squeeze some wastefulness out. individualistic, i don't think we will ever change. that's an essential part ofbeing an american. so at least you're going to always have, thank god, the right to refuse treatment. we don't have the right to treatment, but at least we have the right to refuse treatment, no matter what our family thinks or what the doctors think. so that's good. i want to spend most of the rest of my time on our fascination with tech­ nology and our desire to avoid even discussing death. before i do, i want to think about other barriers to reform. the title i used this morning in the companion speech to this oneat the medical centerwas best in the world. uwe reinhardt argues and obvi­ ously i'm a major fan ofuwethat one major reason we haven't been able to reform healthcare in america is that americans believe that we have "the best" healthcare system in the world, so we shouldn't change it. americans tend to believe everything we do is the "best in the world." uwe was raised in europe, so he's not as jaded as most people. he believes and this is his example, so don't hold it against methat ifl had an elephant here and the elephant took a giant shit right here on the stage that americans would sniff it and declare, "best in the world." no matter what it is, if it's ours, it's the best in the world and we're not going to change that. we're certainly not going to look at eu­ rope or canada or anywhere else to try to change our system because they have nothing to teach us because we're already the best in the world. there's something to say for that reaction, and it's a lot like our reaction to andrew speakertotally disconnected from any factual basis. for exam­ ple, a national opinion poll two years ago showed that fifty-five percent of americans are dissatisfied with their healthcare; forty percent say it's gotten worse in the last five years. on specifics, americans know very little, and what 450 [ndiana health law review [vol. 5:441 they think they know is mostly wrong. more than 100,000 people a year are killed by medical errors in hospitals, but americans think that the number is about 5000. so they think the system's much safer than it is, and they're still totally dissatisfied with that. so best in the world, depends what you mean by best. what's your measure of best? in the most recent survey comparing australia, canada, germany, new zealand, the uk, and the u.s., the u.s. ranks dead last among those six coun­ tries in access, efficiency, equity, and healthy lives, and fifth in quality of care. at least we're moving up in quality of care. you all know the data on infant mortality and longevity; we're in the thirties and forties on those things. so what are we best at? that's a really good question to ask americans if we are going to be able to say we're best in the world. if you ask, they'll say i don't know. well, whatever they do, the government will screw it up, right. what­ ever we do, we don't want it to get worse. and for sure, we don't want "social­ ized medicine." so we are not going to get major healthcare reform simply by exposing facts. more than a change in knowledge is needed to move ameri­ cans to action in this arena. so how do we do it? if you wanted to try to reform the system, how would you talk to your politicians? how would you have your politicians talk to the american people? i have previously suggested adopting the ecology me­ taphor, and emphasizing its core concepts like natural, quality ( oflife ), sustain­ ability, and conservation. but what if we are stuck with our current words and concepts? if you wanted to talk about security, you could talk about security. security brings to mind two things immediately. the first is fear. we've seen that used over and over again. you can make americans afraid of just about anythingexcept chickens. they're not afraid of them. you could also use security for safety. sometimes we use the phrase going to be safe and secure, right? and for some reasonand i really don't know what this isthe patient safety movement really hasn't taken off. i mean, don berwick has done a terri­ fic job. the institute of medicine has pushed it. i'm just surprised it hasn't become a centerpiece in american medicine. there are 100,000 lives, as ber­ wick has pointed out, you could relatively easily save every year. we like to save lives, but in this case we don't do it. so security is still a mixed metaphor. we have homeland security now. we seem to like that, though we don't know what that means, whether it's just anti-immigrant or whether it means something else. security, i don't think is going to do it, even though i would certainly listen to bill clinton who knows that issue a lot better than i do. what about savings savings for whom? who's going to save? somebody' s going to save. do we save by not spending money? savings, i don't think is going to make much of a difference in the healthcare issue either. then there is the issue of qualitybut quality of what? we've been arguing about the quality of our technologywe love technologybut not the quality of our lives. we all say it. i'm sure you say it too. if you're asked if you had a choice between quality oflife and quantity oflife, which would you take? i've never met anybody who wants an extra ten years in the nursing 2008] health care reform in america: beyond ideology 451 home, even an extra ten minutes in the nursing home. so we always say we want quality oflife, the ideal life. willard gaylin, i'm paraphrasing, but i hope he won't mind, has suggested that for americans the ideal death is when you're ninety-five, playing tennis with your mistress, and you suffer a fatal heart at­ tack. i guess you could be playing with your wife too. the example means different things to different people, but the core of the idea rings true. the idea of a quick death, late in life, when you are still physically fit, is tough on your relatives but most people would say good for you, good for you. a long linger­ ing death, stuck in a nursing home with bouts of dementia or progressive alz­ heimer's disease is something that not many of us want, but that's where we're going. that's clearly where we're going. so we have to talk about quality of life and the role of the healthcare industry in promoting quality of life. responsibility is, as i've already suggested, a fundamentally un-american idea. we've tried to tell patients they're responsible for their own illnesses for years. they're not buying it. they don't care whether they weigh 400 pounds, never exercise, and smoke. if they get sick, americans expect to be taken care of. that's it end of story, right? so in this presidential campaign there's a rela­ tively new concept of"shared responsibility." it's a very unclear concept, like maybe we should all share this; we're all in this together. almost looks like european solidarity, which has nothing to do with america and is unlikely to gain any political traction. if you get beyond the rhetoric of shared responsibility in terms of health, essentially people with jobs are expected to pay their own health insurance and through their taxes pay other people's health insurance too. so it's hard to see who shares. choice is a good thing but, as i've already suggested, we need to define what we mean, choice of what? americans want choice of everything­ doctor, treatment, health plan, everythingand i don't think you can reform american healthcare without guaranteeing choice. that's why hillary has moved choice up to number one on her list (replacing security there), and says, "if you like what you have, you keep it." it was john edwards, by the way, who said that first. both hillary and barack have picked up the edwards posi­ tion. you like the way it is? it's your choice. you get to keep it. simplicity, of course, you have to be kidding. no simplicity. that's gone. just forget about that. everything is complicated and likely to get even more complicated. the new magic term in healthcare is "mandate." what kind of metaphor or frame is mandate? if you google the term you get its literal meaning, a date with a man. that makes a lot of sense, right? remember sin­ gle payer? many people still want single payer. you may also recall that dur­ ing the original debate on the clinton plan, large numbers of americans thought that single-payor meant that the health plan only covered single people. words matter and the word "mandate" is too extreme for most americansat least that's my own perception. americans don't like to be told what to do, don't like requirements, don't even like mandatory evacuations, as we've seen a number of times during the hurricanes in florida, houston, and new orleans. even though my state (massachusetts) is famous for passing a mandate and 452 indiana health law review [vol. 5:441 we're trying to figure out how to enforce it (and pay for it) right nowi don't think salvation lies in mandates or in using that term as a metaphor. the three remaining presidential candidates are still mostly stuck with the 1994 rhetoric of health care reform, the democratic candidates with the original six (or five or six) clinton navigational stars, and the republican candidate with an unapologetic market metaphor. here's what the three major presidential candidates now have on their websites. this is not based on any personal dis­ cussion with them; this is on their websites. here are the words and concepts they are using now to frame their healthcare reform positions. hillary clinton has named her plan the "american healthcare choices plan." she's got that through her headchoice, choice, choice. that's what killed the clinton plan in 1994, and is not going to kill it again. americans re­ ally do want choice. she's kept almost all of her other navigational stars as wellsecurity, responsibility, and savings, which is now called "affordable." barack obama has a "plan for a healthy america." he puts public health in there too, i guess, although the only major difference between the sketchy hillary and obama plans is the question of mandates and non-mandates. ba­ rack seeks universal coverage by subsidizing premiums, hillary by subsidizing premiums and requiring the uninsured to purchase insurance. but other than that barack adopts the same basic language, using all of the original clinton six stars, except responsibility. he also adds a few other specifics. he wants to use computerized medical records to modernize the system, and he wants to promote prevention. john mccain supports the market metaphor and relies almost exclusively on using the market to change the system. he states that the way he's going to reform the system is by controlling costs. cost is the biggest issue everywhere. all the talk about controlling costshow's he going to do it? he's going to promote competition, back to the market metaphor, and maintain quality and provide access for all. at least he's got the right wordscost, quality, and ac­ cess. he's back to the approach from thirty years ago talking about the three basic things. still with the conceit, though, that you can improve all three si­ multaneously, that you can increase quality and access and decrease costs all at the same time. so we have a long way to go before we will see healthcare reform. all of the candidates have a long way to go in framing this issue for the public to make it make sense, and they're doing it against this background, a country that is technologically driven and death-denying. and now i am, finally, back to these two pervasive characteristics, and i want to use a couple of what i think are fair but spectacular examples to illustrate how deep these two characteristics go in america. you may remember barney clark. this is the twenty fifth an­ niversary ofbarney clark's operation, when he became the first human being with a totally artificial heart. overnight he became the most famous patient in the history of the world, with the possible exception of lazarus. barney's op­ eration was called a medical miracle, or simply a miracle. we do have some religious connotations in our healthcare as well that are even more difficult to 2008] health care reform in america: beyond ideology 453 deal with than the sacred market. and barney consented to this. it was hard. it was an experiment. but in the u.s. we don't really see a difference between experiments and therapy, so it was treatment, because he was dying, and there was nothing else that could be done to keep him alive. i'll come back to artificial hearts in a second. the other pioneers of artifi­ cial hearts besides bill devries and robert jarvik, are michael debakey and denton cooley in texas. you may remember that cooley stole debakey's heart, which was meant to be a temporary bridge to transplant heart, and im­ planted it in haskell karp in 1979. and those two world-class surgeons did not speak to each other again until about two months ago when they had a reunion. and they're famous, again, because they're big-time surgeons and because they're technologically driven. two stories about these two guys, again, help illustrate america's prob­ lem with technology. the first relates to dr. cooley. when asked recently why in 1979 -when he did the first temporary artificial heart transplantwhy he did it, he said, "i didn't want the russians to beat us again like they did with sputnik." in other words, americans, not russians, should be the world leader in technologyapparently whether the technology had any human usefulness or not. the second story took place about a year and a half ago. dr. debakey was at home, ninety-seven years old at the time, and he had terrible crushing pains, thought he was having a heart attack, and then he decided thatnohe was experiencing a dissecting aortic aneurysm. he's perhaps the world's ex­ pert on that diagnosis. he invented the surgical procedure to treat it. and he decided basically, "that's it. i don't want an operation, because i know the likelihood of me coming out of it with my brain intact is close to zero." so he signed forms stating, do not operate on me under any circumstances. he was able to stay home for a month and not die, and then he lost consciousness. the family then took him to the hospital and said, essentially, "save his life." and they did. he's alive today, and his brain seems fine. this story illustrates how hard it is to die in america. even though we say you have a legal right to re­ fuse treatment, it is difficult to actually do it. again, this is the most informed guy in the world saying he doesn't want treatment, and he gets it anyway. he's now the oldest survivor of a dissecting aneurysm operation in the world, ninety­ eight years old. we look at that as whatbest in the world? that's exactly right. instead of horror, we react with admiration. robert jarvik, the technologically-driven inventor of the artificial heart, the jarvik-7, implanted in barney clark by william devries has lately em­ braced the market metaphor. jarvik's been getting in a lot of trouble lately for acting as a pitchman in the direct-to-consumer lipitor commercials, because some people consider it false advertisement. not that he says anything that's not true about lipitor, but that he portrays himself as a practicing physician. he doesn't say he prescribes lipitor, doesn't actually even say he takes lipitor. the problem is that he's not a practicing physician. he's never been a licensed physician, although he did graduate from medical school. he's an inventor. 454 indiana health law review [vol. 5:441 remember the old ads, "i'm not a doctor but i play one on tv?" they worked because it's more important to play a doctor on tv than to actually be a doctor. jarviki actually like robonce told what i think is one of the great in­ formed consent stories about devries, when asked how you get informed con­ sent to the artificial heart. never been done in a human being before, most likely to let you die a horrible, miserable death, more likely to prolong your dy­ ing than your life. and devries himself told me the story of barney clark's consent. he told me that he read the thirteen-page consent form aloud to bar­ ney clark twice, 24 hours apart, before he asked him to sign it. and he said, "i could have been reading from don quixote, and he would have still signed it." and that's a little frightening. what he meant by that is that clark had read about the artificial heart in the press. clark came to utah to have it done from seattle. you couldn't talk him out of it whatever you put in the so-called con­ sent form. jarvik picks up the story after that, and he says, well, getting the first guy's consent is pretty hard. when you talk to the second candidate, he sug­ gested, devries could say, "in my experience" this has worked very well. when you approach the third candidate, you can say, "in my series this has worked." and by the time you get to the fourth candidate, you can say, "in case after case after case." rob comes to marketing honestly. in addition to our love affair with technology, at some deep level we americans really don't believe we have to die. we know we are going to die, but we are experts at avoiding death in discussions and in denying it. and there are extremes as well. in another life, i have debated members of a group that call themselves transhumanists. they really don't think humans have to die, but can instead become immortal post-humans through technology. they really think that we just need a little more information about physics and biology to literally live forever, close to human. not as humans, not in these bodies, but as energy particles in the cosmos, or as immortal computer chips into which the contents of our brain has been transferred. sounds like fun to me. in any event, no matter what we actually believe, we act as if the major goal of medicine is to prolong life. if someone from another planet observed what we do with healthcare in america, they would likely conclude that we're trying to prolong life as long as possible, trying to extend the average life ex­ pectancy out to 150 years. is that the right length of time? or is there really no acceptable age to die no acceptable life expectancy. are we all debakeys? is our goal really an open-ended extension of life expectancy? public health has, by the way, increased your life expectancy. a lot of you know that for the last 130 years in the united states public health has in­ creased your and my life expectancy seven hours a day every. every day you live, you get another seven hours added to your life expectancy. that's pretty amazing. but is that good enough? talk about quantity. well, no, that's not good enough. we want quality of life too. we want a long life with good qual­ ity. want to age in a teenage body. good luck. again, if you use the military metaphor, you may want everybody to have a robot body, indestructible steel 2008] health care reform in america: beyond ideology 455 plastic body where you can put your brain, maybe in a computer chip, put that in the robot body and that entity will "live" forever. won't be quite you, but it would be a simulated you. maybe we just plug you in. plug your brain into a computer and you'll be dreaming, but you'll think it's real. is that a reasonable goal for humans, a sort of personalized matrix? a more immediate example of the technologically-driven fight for more life that is being fought out in the courts, the fda, and congress, is access to investigational drugs by terminally ill patients. personal stories dominate the public discussion, most prominently by a group called the abigail alliance. abigail's story is as tragic as you can imagine: a nineteen-year-old dying of cancer with no treatments available, an experimental drug on the horizon, but she can't get access to it until the week before she dies. would it have helped? god knows, but her father is convinced that it is essentially a crime to withhold it from a dying person. his position is that in this free country (free market?) people who are dying should have access to anything they want, at least any­ thing that's past phase 1, and at least if they can pay for it. that's the abigail alliance lawsuit. ifthe fda thinks it could be safe, might be safe, safe enough to try in phase 2 or phase 3 experiments, then anybody whose doctor thinks it may be a reasonable thing to try should be able to purchase it and try it. it's a very american argument, and thank god the court said no to it, there is no constitutional right to unapproved drugs, even for terminally ill pa­ tients. the fda can require drugs to go through all three phases before they are cleared for marketing. on the other hand, the fda does have a compas­ sionate use program and other exceptions, so it's not quite true that you can't get access to unapproved drugs. the two judges in the minority, that thought that abigail should have a right to access, used the self-defense excuse, and an american frontier metaphor. if you're dying, you should be able to defend your life, the way americans did on the frontier. self-defense is your right. what's more important than your life -life, liberty, and pursuit ofhappiness? you need life before you can do any of those. the argument, although it lost in this particular case, that americans should have the right to do anything they and their doctor believe is important to do to save their life, really resonates in america. regulatory agencies, tamers of the free market, do not resonateexcept perhaps, after market excesses have led to deaths or financial disasters. ameri­ cans are very ambivalent about government regulatory agencies, including the fda, as we know. i said before we're death denying, but it may be more accu­ rate to say we're ambivalent about death. at some point we know it's coming for us, or for our relatives. and the two cases that illustrate our ambivalence are jack kevorkian, who never, ever could be convicted of assisted suicide. every jury that judged him for assisting in suicide thought it was fine until he actually killed somebodythen a jury decided that his actions were a serious legal violation. you can't actually kill people, even terminally ill people, jack. but the fact that many people still take kevorkian seriously tells us we have 456 indiana health law review [vol. 5:441 many continuing problems with the way we care for (and don't care for) dying people in this country, and we do. the other case that is a favorite of mine is the case of terri schiavo. terri schiavo, and i feel a little strange using her first name, but like karen quinlan and nancy cruzan, and even barney clark, she has become as much a symbol as a real person, was the only patient that the u.s. congress has ever called a special session to decide how she should be treated. the president cut short his vacation to sign the terri schiavo legislation just after palm sunday to "save" terri's life. this is a woman who for ten years was in a permanent vegetative state, whose brain had atrophied to such an extent that almost nobody thought the damage could be reversible. the guru of framing and metaphors, george lakoff, told the congres­ sional democrats at the time, you can't vote against the terri schiavo legisla­ tion, because americans will label you as the party of death, democrats, and you'll have to run next year against the party oflife, the republicans. i mean, it made some sense based on everything you know about americans and their death denying beliefs, but it made no sense based on reality. as senate major­ ity leader and physician bill frist has said he learned in retrospect, americans don't want politicians to make treatment decisions for their loved ones. well, why did bill frist ever think they did? i mean, who in the world ever thought that people writing a living will would stipulate, "ifl'm ever not able to make a decision, i'm incompetent, i want my wife to go to congress and ask the congress and the president how i should be treated and let them decide." i mean, that's almost totally insane. and the other thing that turned out to be very interesting and, i'd like to think, predictablebut i won't go that faris that eighty percent of americans said they thought that the congress was wrong to interfere, and that the decision should have been madeas it ultimately was -by her husband. moreover, large majorities believe that his decision, based on what he believed she would have wanted, to remove the feeding tube, was the right decision to make, and they'd make a similar decision in their own fam­ ily. so we're not totally crazy after all. when our family members are dying, we understand that there are limits and should be limits, and we understand that treatment decisions should be mostly private decisions made in the doctor­ patient relationship, not made in public or in the courts. i want to again threaten to conclude with the image of a famous skull, photographed by robert mapplethorpe, very famous photographer who became controversial after he died in 1988 ofhiv/aids. he'd done a lot of sexually­ explicit photographs, but also photographs that tied sex and death together in a way that many americans found disturbing and alluring in some senses. his photographs don't make you want to run out and kill yourself, but they do make you at least contemplate death, at least think about what you're going to look like in the future, after you die. for me certainly in the next thirty or forty years, probably much less than that, but i don't want to think about thatat 2008] health care reform in america: beyond ideology 457 least not right now. that's our future, and there's nothing healthcare can do about that. we may not be permanent, but maybe we could make our bodies perma­ nent. we have these body exhibitsi don't know if they've come to indian­ apolis -but they have been all around the country. these plasticized human bodies, and nobody knows what to make of those. i don't either. i'm very con­ flicted about seeing real human bodies dissected and plasticized for public ex­ hibition. i mean, it's incredible that you can see the beautiful and intricate anatomical detail. on the other hand, it's very disturbing to see human bodies used as objects of public display, like art objects. their attraction-repulsion speaks to our ambivalence about death, and is not dispelled at all by any notion that the previous owners of these bodies might have consented to the display of their corpse. my own view, after thinking about this for the last two decades, is that we should return to rights talk, and explicitly adopt the all-american rights metaphor for health reform. i think that's the only metaphor that's likely to ever resonate with americans. just as we have a right to emergency care, i think we have to expend more energy and imagination trying to generalize that right to a right to healthcare. one challenge, of course, is to define exactly what we mean by that. it's not going to be the same as the international right to healthcare, not the same as the right described in such detail as in comment 14, but it's in that genre, in the rights ballpark, and i think we are fully capable of defining what we mean by basic, decent healthcare that every american should have a right to. hillary is not using that language on her website, but has used it in some of her speeches. she has declared, "health care should not be a privilege. health care should be a right." she used rights language, and i think that she's right to use rights language in this context. obama may use it too, but i haven't heard him use it. i can guarantee you john mccain has never used the rights metaphor in this context. it's like the right to education. i think we could explain that to ameri­ cans. everybody has a right to education. we think that you cannot live a de­ cent human life without an education, and you can't live a decent human life without having access to decent healthcare either. that should be part of what it means to be an american. put another way, to change american healthcare we will have to change america itselfsince healthcare is a mirror metaphor for america. the only plausible way to change america, at least in the short run, is to expand or redefine one of our inherent characteristics. since death denial and technology fascinations have become part of our national ideology, it is unlikely that attacking them directly will yield results. we are a rights-based country, and increasing our rights, especially our individual rights, may be the most effective way to gain public support to make more than a marginal change in the present system. i started with susan sontag, and i'll end with her. she is, i think, the person who knew the most about metaphors in medicine, who decried the mili458 indiana health law review [vol. 5:441 tary metaphor, the lack oflimits, the over mobilization, the use of the body as a battlefield, and who herself beat breast cancer. in her personal "battle" with breast cancer she insisted on the most aggressive treatment, a radical mastec­ tomy follow-up with intense chemotherapy. thirty years later, likely as a result of the chemotherapy, she contracted myelodysplastic syndrome the untreatable precursor to fatal acute myeloid leukemia. she nonetheless determined that she would do exactly what she did with her breast cancer. she wanted everything done. she would not hear anybodyand very few people do -tell her it was incurable and that there was no treatment. she wanted everything. anyway, her son, david rieff, describes his mother's last year oflife in his book swimming in a sea of death. reviewers of the book have put it mildly: if there is a hard death, hers was one of the hardest deaths that any­ one's ever endured. she was in constant pain and suffering for almost every hour of her last year oflife. except, her son says, for the last two or three hours of her life when she finally understood that there was nothing else that could be done. my own point is not that susan sontag had a horrible deathshe did have a horrible deathbut she is, like debakey, the most knowledgeable pa­ tient there is, and an expert on the damage the military metaphor, combined with death-denial and technological wizardry, can do to real people. she really did know that science and medicine had nothing to offer her, that the only very slim possibility was in an incredibly painful and isolating bone marrow trans­ plant, which she nonetheless endured. she clung to hope, even when there was none. the point is not to judge her, but rather to note that her's was an alto­ gether american death, a death that we remain incapable of avoiding. if susan sontag and michael debakey can't say no, neither can america. joan didion entitles her own book about the death ofher husband and her daughter, magical thinking. we all share magical thinking, but it's based on the notion that we don't really have to dieif we just did something. i'm go­ ing to be the exception. yes, i know everybody dies, but i'll be the one person who doesn't die. it's not going to happen to me. the only point is that we americans get a lot out of the current health­ care system, and therefore making any meaningful change in it is going to be extraordinarily difficult. even identifying the problems inherent in being tech­ nologically driven and death denyingand i really do believe they are inherent problems does not take us anywhere near effectively addressing them. they're big problems, and they're very deeply rooted in the american psyche. so let me end (really) with another metaphor, a shipwreck. i said we're not sure whether reforming american health care will require a train wreck, bus wreck, or another type of catastrophe or collapse, but this is gericault's famous painting, the rcifi of the medusa. it provides a fitting image on which to con­ clude our discussion of american healthcare reform. the painting is of the sur­ vivors on a raft constructed after their ship has sunk off the african coast. about 150 survivors cast off from the wreck on this raft. others made it to shore on life boats. the painting is a representation of the survivors fifteen 2008] health care reform in america: beyond ideology 459 days later, when of the original 150, only eighteen bodies remain on the raft, three corpses and fifteen live humans. all the others are dead, victims of muti­ nies, murders, cannibalism, of almost every horror known to human beings. in the painting there is a black man at the top (the ship was involved in the slave trade) who is signaling to a ship, which you can just barely make out on the horizon. julian barnes has written eloquently about his thoughts on studying this painting: "how rarely do our emotions meet the object that they desire. how hopelessly we signal. how dark the sky and how big the waves." he con­ tinues, "we are all lost at sea, washed between hope and despair, hailing some­ thing that may never come to rescue us." i don't know ifl want to go so far as to use that as a metaphor for american medicine today, but its close. i think we're all trapped between hope and despair. we'd like to think that there is something that's going to come and rescue the healthcare system, before it does implode, but we all know that it may have to implode before we can change it, because we are absolutely wed to technology and absolutely refuse to take our mortality seriously. thank you very much. i know we're over time, but i want to take one or two questions. question: one more metaphor for you. that's the apocalyptical me­ taphor. that's what you have up there. the takeaway here is that a rational reform of the american healthcare system is essentially impossible until it im­ plodes, if even then; correct? mr. annas: i'd like to think the answer's no, but i think that's true, unfortunately, yes. and why doesn't it implode? this is, again, larry brown's thing, because we do have this kind of safety net that allows us to not have people die on the streets. so we're not going to have a revolution. so we do take care, and we have the right to emergency care. which is so bizarre, isn't it? that's, the most expensive, most last-ditch care there is, but we do have a right to that. i don't know. i wish i could have more. maybe we need a prophet. hillary's been through it a lot, so maybe she could do it. barack's like a prophet. maybe we need a prophet. i don't know, but i wouldn't bet a lot of money on it. i wouldn't mortgage my house right now. i don't think it's going to happen this time because it's really ex­ pensive. almost five percent of all the money that's spent in the entire world, on everything, is spent on healthcare in america, one dollar out of every twenty dollars. how can that possibly be? it's not as if that's the only thing we spend money on. we spend an incredible amount of money. the other safety valve is medical tourism. it's also a type of safety net. people who can't afford care in the us go to india. i'm sure no one here ever thought in their wildest imagination americans would go to india for health­ care. i don't want to say india's bad. india's not necessarily bad. but, we don't think oflndia as having cutting-edge technology in medicine. they do though. they can do it cheaper. they can do most operations for half or a 460 indiana health law review [vol. 5:441 quarter of what we can do it for. so americans are going to india for health­ care. they're going to mexico for healthcare too, because it's much less ex­ pensive than here, not because they think it's better there. it's cheaper there. question: where does trust fit into a national healthcare law? i know a lot of people don't trust the government for healthcare when it can't even get a driver's license number correct or social security number correct. mr. annas: well, they certainly can't be trusted to register your motor vehicle. i can tell you that. we were going to have them document or­ gan donation on driver's licenses in massachusetts, but the legislature said no, we can't do that. trust is really important. i talked a little bit about the military metaphor. one thing we don't use it for is to say that the government should run healthcare the way the govern­ ment runs the military. only the government can raise an army, only the gov­ ernment can buy and control advanced weaponry, like nuclear weapons. so if we took the military metaphor seriously, we'd say, the government should run medicine. instead what we sayand mccain says this a lot, and so did my former governor, mitt romney, when he was runningwe don't want a "hillary care," or, more generally, we don't want "socialized medicine." no one's proposed socialized medicinemaybe they shouldbut so­ cialized medicine is when the government doesn't just pay all the bills, but owns the means of production, owns all the hospitals and clinics, and all the doctors and nurses are government employees. that is what they have in eng­ land. that's what we have in the veterans administration. that's what we have in military medicine. it's not what anybody' s proposing for the country, but at some point they will. it's like what churchill said about america, that we'll come to the right decision but only after we've tried everything else. at some point we're going to come to the british system, the national health ser­ vice, but we're a long way away from that. we first have to show that every­ thing else doesn't work. there are at least some analysts in massachusetts that think that our mandate system, in which everybody buys their own health insurance, is just a step in the direction of government providing insurance coverage for every­ body. once we show that it's impossible to actually mandate people to pur­ chase insurance they can't afford, we're going to ultimately say we'll just cover everybody. i don't know if that's true or not, but at least it moves us in the right direction by significantly reducing the number of the uninsured. i don't want to argue against what my state is doing. at least it moves it in the right direction. we've covered another 300,000 people in massachusetts, and that's good. the idea we're going to cover everybody seems unlikely. the government is involved in healthcare. this morning at the medi­ cal center, after discussion, one of the people said, well, maybe the way to frame it is not single payer, the way a lot of people do, like the canadian sys­ tem, but to talk about what ted kennedy's been talking about latelymedicare 2008) health care reform in america: beyond ideology 461 for all. most americans are very fond ofmedicare. you certainly can't take medicare away from them. but they may want to change it and do it better. doctors may want higher payment rates, and i don't blame them at all. medi­ care is basically a very efficient system and americans really like it a lot, and expanding medicare may have more political attraction than creating any kind of new program. there are really two ways to think about this, and this takes me back to my beginning days in this field, in the 1970s. we think about two ways to get to national health insurance. one is by age, by just lowering the age ofmedicare every few years and increasing it at the other end. cover children and then cover people to twenty-one, then to twenty-four. so one way to change things is by age, being more and more inclusive. the other one is to go "disease by disease" to national health insurance. i don't know if you remember the end stage renal disease program. in 1970, we decided we were going to cover everybody who needs renal dialysis, because it was so expensive and it was a lifesaver. we decided that we were just going to have national health insurance for renal dialysis. we still do, by the way. it's the only thing we have national health insurance for, because it turned out to be more than twenty times more expensive than imagined. so we didn't go disease by disease, and we don't cover children although we could still go age by age, but neither one looks like a likely path. indiana iieaith law review volume3 issue 2 introduction eleanor d. kinney mcdonald-merrill-ketcham memorial award for excellence in law and medicine history recipients pay-for-performance: will it work in theory? william m. sage symposium aligning hospital and physician incentives in the era of pay-for-performance william h. thompson c. paul wazzan,kali prasun chowdhury, an economic analysis of the impact of pay-for-performance initiatives on physicians, patients and insurance providers pay-for-performance in centra/indiana william r. sellman, michael a. zimmerman david e. kelleher, j. marc overhage articles pay-for-performance or compliance? richard dolinar, s. luke leininger a second opinion on medicare reimbursement report of the council on ethical nathan a. bostick, robert m. sade, and judicial affairs: physician pay-forjohn w. mcmahon peiformance programs can money buy quality? physician response to pay-for-peiformance advancing quality through collaboration: the california pay-for-performance program 2006 thomas bodenheimer, jessica h. may, robert a. berenson, jennifer coughlan integrated healthcare association indiana health law review volume3 2005-2006 editor-in-chief richard w. swett, jr. executive managing editor paula j. beller executive production editor kathryn a. fox executive business editor c. jason hannagan executive notes editor deborah c. edwards executive anicles editoi's joshua a. claybourn tammy r. murray note development editoi's richelle m. harris kristen w. heath kelly a. mackinnon erin w. southwell a11icleseditoi's paull. carroll meghann e. labadie christopher j. mcelwee april e. meade associllteeditoi's timothy j. hixson april a. marshall jaclyn m. palos chad a. robertson robin s. tubesing christopher a. americanos brent r. borg christopher m. campaniolo russell b. cate clifton b. cislak shana m. collier bernice v. conway richard c. coming, jr. carly s. everett raegan m. gibson lauren n. grattenthaler angela k. grogan chelynne l. harris neil f. hazaray membei's lynn m. hefner adam hollander-urbach shannon n. jamison kimberly a. kessinger leigh ann lauth davidl. nie colleen m. powers elizabeth j. raynor beth a. schenberg rachel a. scherer scott i. smith danielle l. spain brandt r. voight jennifer l. wilson · faculty advisoi's lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics ofhealth law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2005-06 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university school of lawindianapolis. subscriptions. current subscription rates are $10.00 per issue 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western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. ab., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.sj., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. william f. harvey, carl m. gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of law emeritus, ab., harvard college; j.d., rutgers university school oflaw-newatk. william andrew kerr, professor of law emeritus. ab., west university; b.s., duke university; j.d., ll.m., harvard law school. william e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronald w. polston, professor of law emeritus. b.s., eastern lllinois university; ll.b., university oflllinois college of law. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james w. torke, professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. draoomir cosanici, head of reference. b.a., michigan state university; m.i.l.s., university of michigan; j.d., university of kansas. debra densla w, reference librarian. b.a., franklin college; m.s., university of lliinois, urbana-champaign; j.d., valparaiso school of law. mary hudson, reference/circulation librarian. b.a., ball state; m.l.s., indiana university. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university ofkentucky. , wendell e. johnting, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. chris e. long, catalog librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. mahnazk. moshfegh,acquisition/serials librarian. b.a., national university oflran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriama.murphy,associatedirectoroflaw library. b.a., purdue university; j.d.,m.l.s., indiana university-bloomington. kiyosm otsu, computer system specialist. a.a., parkland college; a.b., m.s., c.a.s., university oflliinois. indiana health law review volume3 issue 2 table of contents introduction ............................ eleanor d. kinney xvii mcdonald-merrill-ketcham memorial award for excellence in law and medicine history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxi recipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxiii pay-for-performance: will it work in theory? william m. sage 303 symposium aligning hospital and physician incentives in the era of pay-for-performance william h. thompson an economic analysis of the impact of pay-for-performance initiatives on physicians, patients and insurance providers 325 . • . . . . • . . . . . . . . • . • c. paul wauan, kali prasun chowdhury, william r. sellman, michael a. zimmerman 349 pay-for-performance in central indiana ...................... david e. kelleher, j. marc overhage 371 articles pay-for-performance or compliance? a second opinion on medicare reimbursement ..........•............ richard dolinar, s. luke leininger 391 report of the council on ethical and judicial affairs: physician pay-for-performance programs . . . . . . . nathan a. bostick, robert m. sade, john w. mcmahon 421 can money buy quality? physician response to pay-for-performance . . . . . . • . . . . . . . • . . . . . . thomas bodenheimer, jessica h. may, robert a. berenson, jennifer coughlan 443 advancing quality through collaboration: the california pay-for­ performance program integrated healthcare association 453 2006 microsoft word 1-masthead vol. viii.doc elizabeth burleson professor burleson has an ll.m. in international law from the london school of economics (lse) and is a fulbright senior specialist. she began participating in treaty negotiations at the united nations in 1991 during proceedings for the united nations conference on the environment and development and helped draft the united nations framework convention on climate change (unfccc), agenda 21 and the rio declaration. she has written reports for the united nations and delivered presentations at united nations conferences. focusing on emerging international law, professor burleson has been an advisor to unicef's senior advisor for the environment and the new york director of unep. she has also written reports for unesco and undp. a particular focus has been placed on design, development and implementation of human rights and environmental programs. she was a member of the unicef delegation to the bali climate conference; worked with the nwf and unep delegations to the copenhagen climate conference and with the iucn and asil delegations to the cancun climate conference. professor burleson has also conducted legal research for amnesty international's london-based international secretariat and new york-based research division. she is joining the faculty of pace law school. as a national university of singapore centre for international law visiting fellow, she researched energy and water security. she teaches public international law, energy law, international environmental law, un law, international law and china, property law, water law, and environmental law. she also teaches energy law at the university of connecticut school of law, and international trade and the environment as a fulbright senior specialist. professor burleson has been a visiting law professor at florida state and university of oregon. perspective on economic critiques of disability law: the multifaceted federal role in balancing equity and efficiency elizabeth burleson* abstract given the recent enactment of the ada amendments act, this article analyzes a rawlsian philosophical framework with which to view society’s treatment of people with disabilities. allocation of resources remains a pervasive concern of economists and attorneys alike. need, merit, and market compete as means by which to decide who should receive what benefits. this article concludes that while economics can play a powerful role in the initial allocation of limited resources, there remains a multifaceted federal role to confront discrimination and promote equity. i. introduction ............................................................................... 338 ii. a philosophical framework with which to assess disability law ............................................................................ 339 iii. a paradigm shift in attitudes towards disabilities ......... 341 a. the rehabilitation act of 1973 ................................................ 342 b. equal access and opportunities to education ........................ 343 c. individuals with disabilities education act (“idea”) ........... 345 1. conflict between the traditional educational system and idea ........................................................................... 345 2. funding special education and the complexity of disability evaluations ....................................................... 347 3. competing interests ........................................................... 347 4. an economic model for allocating special education services .............................................................................. 348 5. the rowley case ............................................................... 349 6. proportional quality ......................................................... 351 d. an “otherwise qualified individual” under section 504 ....... 353 iv. the americans with disabilities act of 1990 ....................... 355 a. administrative and judicial enforcement .................................. 356 b. the bartlett case ....................................................................... 357 * professor elizabeth burleson has an ll.m. from the london school of economics and political science and a j.d. from the university of connecticut school of law. she teaches at pace law school (visiting professor at the florida state university college of law). she also writes reports as a consultant to the united nations. 338 indiana health law review [vol. 8:2 v. recommendations ...................................................................... 360 vi. conclusion .................................................................................. 362 i. introduction the americans with disabilities act (“ada”) amendments act (“adaaa”) went into effect in 2009,1 rekindling the federalism debate regarding education. as an expansion of the americans with disabilities act of 1990,2 the adaaa rejects the sutton trilogy3 requirement that mitigating measures be factored into a disability analysis.4 instead it reinstates the reasoning of the supreme court in school board of nassau county v. arline.5 eleven percent of students in higher education have disabilities,6 and ten percent of these students have learning disabilities.7 a significant level of awareness has been raised concerning the needs of people with disabilities, yet increased visibility and legal protections have been met with strong resistance. while disability advocates speak of fundamental civil rights, opponents speak of economic costs. law and economics can provide much needed guidance based upon well-reasoned theories and have contributed 1. ada amendments act of 2008, pub. l. no. 110-325, 122 stat. 3553 (codified as portions of 42 u.s.c. §§ 12101-12214 and 29 u.s.c. § 705 (2008)). 2. americans with disabilities act of 1990, pub. l. no. 101-336, 104 stat. 327 (codified as amended at 42 u.s.c. §§ 12101-12213 (2009)). 3. sutton v. united airlines, inc., 527 u.s. 471 (1999); albertson's, inc. v. kirkingburg, 527 u.s. 555 (1999); and murphy v. united parcel service, inc., 527 u.s. 516 (1999). 4. congress expanded the rules of construction regarding the definition of disability to specify in (e)(i) that “[t]he determination of whether an impairment substantially limits a major life activity shall be made without regard to the ameliorative effects of mitigating measures.” 42 u.s.c. § 12102(4)(e)(i) (2009). 5. ada amendments act of 2008, § 2(b)(2)-(3); see also school bd. of nassau county v. arline, 480 u.s. 273 (1987). 6. u.s. gov't accountability office, gao-10-33, higher education and disability: education needs a coordinated approach to improve its assistance to schools in supporting students 6 (2009); see also laura rothstein, higher education and disability discrimination: a fifty year retrospective, 36 j.c. & u.l. 843, 871 (2010). 7. u.s. gov’t accountability office, gao-10-33, supra note 6, at 11. (noting that “the return of veterans with a variety of conditions ranging from mobility impairments to post traumatic stress disorder will present new challenges for colleges and universities. the post-9/11 veterans educational assistance act of 2008, pub. l. no.110-252, 122 stat. 2357 (codified at 38 u.s.c. § 3313 (2008)), provides funding for tuition and fees, housing, and other assistance for returning veterans. this is likely to increase the number of individuals on campus returning from active service. not only might the services they request be challenging, but there may be legal issues about documentation. individuals returning from active service may not be able to get the traditionally required documentation quickly from the military to justify an accommodation, and institutions will need to determine whether they can adapt their policies to this new population”); rothstein, supra note 6, at 873; see also paul d. grossman, foreword with a challenge: leading our campus away from the perfect storm, 22 j. postsecondary ed. & disability 4 (2009). 2011] economic critiques of disability law 339 immeasurably to the sound application of laws and policies. law and society scholars have provided countervailing analyses that remain mindful of the need for humane laws and policies. this article begins by offering a philosophical framework with which to view society’s treatment of people with disabilities. in doing so, part ii attempts to balance the predominantly economic approach by which disability issues have been assessed. part iii then directly addresses the economic way in which the individuals with disabilities education act (“idea”)8 has affected resource allocation to special education. next, part iii considers what happens to individuals who fall outside of idea protection once they reach the age of twenty-one. many students in this situation have turned to section 504 of the rehabilitation act.9 in the post-secondary context, courts have struggled with the level of protection that the rehabilitation act provides. instead of explicitly addressing economic costs of compliance, much of the analysis in this area has revolved around the clarification of who is “otherwise qualified.” part iv addresses the intense debate over legislative language that has continued, despite a congressional effort to strengthen its mandate to eliminate discrimination against disabilities by enacting the ada.10 in the context of higher education and professional entrance examinations, there has been less mention of direct cost benefit analyses. instead, the debate has revolved around academic standards. beneath this discussion, however, there is an economic productivity debate. the following analysis focuses on the economic undercurrent that has pervaded the process of establishing and implementing civil rights for people with disabilities. this article concludes that while economics can play a powerful role in the initial allocation of limited resources there remains a multifaceted federal role to confront discrimination and promote equity. ii. a philosophical framework with which to assess disability law the american legal philosopher, john rawls, described a state of nature in which individuals have complete freedom within the following hypothetical societal framework.11 people are initially identical with regard to physical strength, financial security, religion, race, etc.12 moreover, these 8. individuals with disabilities education act (“idea”), pub. l. no. 101-476, 104 stat. 1142 (codified at 20 u.s.c. §§1400-1482 (2006) (formerly known as the education for all handicapped children act)). 9. rehabilitation act of 1973, pub. l. no. 93-112, § 504, 87 stat. 355, 394 (codified at 29 u.s.c. § 794 (2011)). 10. americans with disabilities act of 1990, pub. l. no. 101-336, 104 stat. 327 (codified as amended at 42 u.s.c. §§ 12101-12213 (2009)). 11. john rawls, a theory of justice 136 (1971). 12. david j. popiel, the debate over the americans with disabilities act: a question of economics or justice? 10 st. john’s j. legal comment. 527, 530 (1995). 340 indiana health law review [vol. 8:2 fungible individuals have no idea what they will become in the future.13 given these two basic tenets, rawls predicted that the rules people would establish would be fair because no one would be able to skew them to benefit a given individual circumstance.14 in this way, we can assess our own laws by considering whether a given rule would have been agreed upon in rawls’ state of nature. disability legislation, such as the ada, holds up very well if such a rawlsian comparison is made. in fact, the disability field provides an excellent real-world scenario for rawls’ hypothetical decision-making process since no one knows whether they will have to contend with a disability in the future.15 since our ability to determine whether or not we would individually benefit from disability legislation mirrors rawls’ state of nature, it is not surprising that ada provisions in many ways reflect an undifferentiated decision-making process. without knowing one’s future, individuals would like to be assured that if they acquire a disability in the future, society will provide basic accommodations. similarly, if they decide to be employers in the future, these same individuals would want to be assured that accommodating disabilities would not be exceedingly expensive.16 thus, rawls provides a rationale for moving beyond a utilitarian discussion of whether the ada’s financial costs outweigh its financial benefits.17 as popiel notes, the fact based utilitarian balancing act does not define fundamental fairness. if the provisions of the ada pass rawls’ reason based state of nature test, they are just, and there is a strong argument for retaining them in spite of their cost. our society glorifies the economic marketplace; but, in thinking about the worth of laws, marketplace analysis has its limits.18 much of the criticism of disability legislation is couched in the argument that the costs outweigh the benefits. cries that disability provisions such as the ada are too expensive have been countered with assurances that the costs of accommodating disabilities are generally low. economic arguments have a useful place in society, but they cannot be relied upon as the only indicator of what and how civil rights should be protected. it is important to assess measures that protect people with disabilities in ways that go beyond a narrow framework of economic efficiency. it is not suffi 13. id. 14. id. 15. id. at 531. 16. id. 17. id. 18. id. at 531-32. 2011] economic critiques of disability law 341 cient to measure the quantifiable monetary successes or failures of disability legislation to the exclusion of addressing attitudes and their philosophical underpinnings. as popiel notes, “[i]t is principles, not what you call ‘empirical data,’ that will tell you what is right and what is wrong . . . . it is justice that we are after, and justice is not always, or even often, amenable to precise measurement, or even to measurement at all.”19 popiel goes on to point out that there are other expenditures for which society is willing to pay that can be extremely costly. for instance, in the context of providing fair trials for criminal defendants, looking solely at financial costs rather than the central issue of fairness is likely to lead to a substantial reduction in procedural protections. the fact that we do not perform a pure dollar and cents analysis in ensuring the right to a fair trial indicates that empirical reasoning is not the only grounds upon which we make decisions. communities allocate resources based upon a combination of need, merit, and market. in the context of recognizing reasonable accommodations for individuals with disabilities, an even playing field can be established by interpreting and implementing federal legislation in a manner that balances efficiency and equity. iii. a paradigm shift in attitudes towards disabilities societies throughout history have often excluded or ignored people with disabilities. misconceptions of an inability for people with disabilities to contribute to society have fostered continued discrimination. the piecemeal approach in which disability legislation has been enacted provides a record with which to trace the gradual transition in perspectives. the united states has come a long way in its treatment of people with disabilities. throughout the early 1800s states primarily institutionalized such individuals. income maintenance programs, such as workers compensation in 1911 and social security disability policy in 1935, marked the first attempts to establish a national disability policy. benefits initially consisted of financial support at a subsistence level, but with little accompanying effort to welcome people with disabilities into mainstream society. world war i marked a turning point in the role that the federal government has played in disability issues when the enormous influx of returning veterans with disabilities prompted the government to establish vocational rehabilitation services.20 the 1920s ushered in an era of vocational rehabilitation with a “corrective” rational that would return people to the workplace. this economic, marketplace approach sought to mold the individual with a disability into his or her existing surroundings, rather than 19. id. at 529. 20. judith welch wegner, the antidiscrimination model reconsidered: ensuring equal opportunity without respect to handicap under section 504 of the rehabilitation act of 1973, 69 cornell l. rev. 401, 403 (1984). 342 indiana health law review [vol. 8:2 make an effort to alter the individual’s physical surroundings to accommodate his or her needs, or confront the prejudice and ignorance that contributed to his or her exclusion. as a result, individuals with disabilities remained isolated. a philosophical paradigm shift began in the 1960s as people started to recognize that all individuals have a fundamental worth and potential. a. the rehabilitation act of 1973 prior to 1973, any special education provisions that existed were based upon disability legislation at the state level. congress took steps to combat disability discrimination on a national level by passing the rehabilitation act of 1973.21 while the civil rights act of 1964 did not provide protection from discrimination on the basis of disability, it did serve as a foundation for the rehabilitation act.22 the rehabilitation act had the goal of “providing equal rights for the nation’s twenty-eight to fifty million physically and mentally handicapped.”23 the act implemented a program to integrate people with disabilities into all areas of society. section 504 of the act states that, “no otherwise qualified [handicapped individual] in the united states . . . . shall, solely by reason of his handicap, be excluded from the participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal financial assistance.”24 while in the original rehabilitation act of 1973, the phrase “qualified handicapped individual” only encompassed individuals who could benefit from employment, a 1974 amendment incorporated a broader definition containing the following three components: “(a) a physical or emotional impairment that substantially limits one or more of the major life activities of such an individual; (b) a record of such an impairment; or (c) being regarded as having such an impairment.”25 under this definition, learning is considered a “major life activity.” therefore, people with learning disabilities are protected in their educational pursuits. the rehabilitation act, and section 504 in particular, has served as the foundation for broad policies prohibiting discrimination against people with disabilities. the act contains several serious weaknesses, however. among the most important criticisms of the rehabilitation act are that it is 21. rehabilitation act of 1973, pub. l. no. 93-112, § 504, 87 stat. 355, 394 (codified at 29 u.s.c. § 794 (west 2011)). 22. see civil rights act of 1964, pub. l. no. 88-352, 78 stat. 241 (codified as amended in scattered sections of 2 u.s.c., 28 u.s.c., and 42 u.s.c. (2010)). 23. steven w. gerse, mending the rehabilitation act of 1973, 1982 u. ill. l. rev. 701, 701 (1982). 24. rehabilitation act of 1973, § 794(a). 25. rehabilitation act amendments of 1974, pub. l. no. 93-651, §111(a), 89 stat. 2, 2-3 (1974). 2011] economic critiques of disability law 343 ambiguous in its language and is limited in its scope. since only recipients of federal financial assistance fell within the act, much of the private sector could continue to discriminate against people with disabilities. to remedy this flaw, congress introduced new legislation to strengthen the rehabilitation act’s protection.26 this process culminated in the passage of the ada, which is discussed further in section iv. b. equal access and opportunities to education the doctrine of “separate but equal” did not reach the supreme court until1896 and was not originally established in relation to disability, or to education. instead, plessy v. ferguson27 involved transportation. the case most people associate with the doctrine, however, is brown v. board of education,28 in which african-american elementary school children in topeka, kansas were given the right to go to an integrated school. initially, the three-judge district court, found that segregation in public education had negative effects on african-american children, but denied relief on the ground that the segregated schools had roughly similar buildings, transportation, curricula, and educational qualifications of teachers.29 such a finding disregarded the argument that segregation itself inflicted a sense of inferiority, which affected the motivation of a child to learn. the supreme court concluded that “separate educational facilities are inherently unequal.”30 this raises the question of how the “separate is unequal” conclusion relates to individuals with disabilities. segregation of special needs students dates back at least as far as the 1800s when states began organizing separate schools for the deaf and blind. kentucky opened the first state school for the deaf in 1823. similar schools in ohio, massachusetts, and new york soon followed. special education programs were not integrated into public schools, however, until the 1960s. even when physical integration did begin to take place, this development did not have a significant effect on the teaching approach taken with special needs students or on their exposure to peers who did not have disabilities. the contemporary concept of mainstreaming only began in the 1970s in the wake of the following court cases and federal statutes. in 1971, pennsylvania association for retarded children (“parc”) v. commonwealth of pennsylvania challenged a state law that discriminated against children with disabilities based on the assumption that they would 26. president reagan created the national council on disabilities, which ultimately authored public law 101-336, otherwise known as the americans with disabilities act (“ada”). 27. plessy v. ferguson, 163 u.s. 537 (1896). 28. brown v. bd. of educ., 347 u. s. 483 (1954). 29. id. at 486. 30. id. at 495. 344 indiana health law review [vol. 8:2 be unable to profit from public school.31 specifically, parc challenged the constitutionality of a pennsylvania statute that excluded retarded children from public schools.32 the supreme court struck down the statute and required pennsylvania to stop “deny[ing] to any mentally retarded child access to a free public program of education and training.”33 this case was followed by mills v. board of education of the district of columbia, in which the court found that schools could not deny services on the basis of cost, but instead had to extend the right to free and appropriate education to special needs children.34 the court held that a school cannot exclude a child unless it provides, “adequate alternative educational services suited to the child’s needs which may include special education or tuition grants . . . . [and] a constitutionally adequate prior hearing and periodic review of the child’s status, progress, and the adequacy of any educational alternative.”35 mills is most often quoted for its requirement that districts must not exclude special needs students on the basis of a school’s lack of resources. the court established this with the strong statement that, if sufficient funds are not available to finance all of the services and programs that are needed and desirable in the system then the available funds must be expended equitably in such a manner that no child is entirely excluded from a publicly supported education consistent with his needs and ability to benefit there from. the inadequacies of the district of columbia public school system whether occasioned by insufficient funding or administrative inefficiency, certainly cannot be permitted to bear more heavily on the ‘exceptional’ or handicapped child than on the normal child.36 this language in mills and the protection outlined in parc became instrumental in the creation of subsequent federal legislation. in 1975, congress passed the education for all handicapped children act (“eahca”).37 both the house and the senate reports attribute the impetus for this act to the two federal court judgments previously discussed, parc and mills.38 most importantly, the term “appropriate” apparently 31. parc v. pennsylvania, 334 f. supp. 1257, 1258 (e.d. pa. 1971). 32. id. 33. id. at 1258. 34. mills v. bd. of educ., 348 f. supp. 866 (d.c. cir. 1972). 35. id. at 878. 36. id. at 876. 37. education for all handicapped children act of 1975, pub. l. no. 94-142, 89 stat. 773 (1975). 38. hendrick hudson bd. of educ. v. rowley, 458 u.s. 176, 180 (1982). 2011] economic critiques of disability law 345 came from these cases. in the parc case, the district court required that handicapped children be provided with “education and training appropriate to [their] learning capacities”39 and in mills, the district court referred to the need for “an appropriate educational program.”40 the eahca was amended in 1990 and renamed the individuals with disabilities education act (“idea”).41 c. individuals with disabilities education act (“idea”) despite the growing realization that children with disabilities could benefit educationally from being in the regular classroom, many states continued to deny educational services on the basis of cost and institutional difficulty. in the early 1970s, it was estimated that one to two million children were excluded from public school services.42 congress used the conservative one million figure to argue for the passage of idea and incorporated the “child find” program into the legislation.43 this initiative succeeded in locating many previously-excluded children with disabilities. while the department of health, education, and welfare (“hew”) estimated that 463,000 children remained excluded from school in 1976, by 1980 the figure had dropped to 22,600.44 just as excluded students were entering the public school system, the number of newly identified special needs students increased dramatically rising from 2.1 million children in 1966, to 4.2 million in 1982.45 1. conflict between the traditional educational system and idea beyond the misconceptions people have about disabilities, acceptance of idea is further hindered by the fact that the legislation is contradictory to the system in which it has been implemented. idea introduces a needsbased approach into a merit-based educational system.46 under the statute, the role of educational merit and needs are reversed. that is to say, the special needs students who have the lowest performance often receive the most resources.47 39. parc v. pennsylvania, 334 f. supp. 1257, 1258 (e.d. pa. 1971). 40. mills, 348 f. supp. at 879. 41. 20 u.s.c. § 1400 (2006) (describing the reasons for amending the eahca). 42. william h. clune & mark h. van pelt, a political method of evaluating the education for all handicapped children act of 1975 and the several gaps of gap analysis, 48 l. & contemp. probs. 7, 15 (1985). 43. id. for information on “child find” see us office for special education at http://www.childfindidea.org/overview.htm. 44. clune & van pelt, supra note 42, at 15. 45. id. 46. 20 u.s.c. § 1412 (a)(3) (2006). 47. katherine t. bartlett, the role of cost in educational decisionmaking for the handicapped child, 48 l. & contemp. probs. 7, 24-26 (1985). 346 indiana health law review [vol. 8:2 while idea calls for an individualized educational program for a special needs student, school systems are based on a system of standardization in which a set of uniform educational opportunities is provided.48 in such a system, the ideal goal is to become blind to individual backgrounds. in this respect, educators may see the inclusion movement as a way to bridge this discrepancy between individual and collective approaches. yet, inclusion sometimes becomes an economic catchall approach for denying services. the placement of all children with disabilities in the regular classroom is as great a violation of idea as is the placement of all children in separate classrooms on the basis of their type of disability. inclusion is not universally good or evil. different children require different services. for instance, a down syndrome child benefits from socialization opportunities in the regular classroom, while a child with a mild learning disability benefits from separate, remedial academic skill-building. those seeking socialization can benefit from inclusion but this should not be grounds for insisting that children who are seeking the same educational goals as their non-disabled peers can equally benefit from inclusion. watering down a concept so that it can be learned within the constraints of the traditional classroom does not help the latter. the basis of inclusion is a modified curriculum, essential for some children with disabilities and inadequate for others. idea brought a compulsory funding requirement into a political system of resource allocation―a system in which negotiations determine how much money goes where.49 the following political disadvantages facing special needs students at the local level indicate why congress deemed it necessary to ensure their individual rights. discomfort and prejudice toward people with disabilities remains widespread. greater understanding is hindered by the reality that teachers and administrators are overburdened and are already struggling to adjust to funding shortages, while juggling increasingly overcrowded classrooms, high student-teacher ratios, and outdated facilities.50 despite the need to protect children with disabilities from systematic discrimination, introducing federal control into a system historically run by state and local decision-makers increased the animosity of schools toward special education.51 when public education was first created in the united states, decisions were made on a local level by parents and the local government.52 during the nineteenth century, schools were consolidated and increasingly made accountable to states.53 in contrast, the uniform federal procedures established under idea limit local autonomy. 48. id. at 20. 49. id. at 21. 50. id. at 23. 51. id. at 26. 52. id. at 27. 53. id. 2011] economic critiques of disability law 347 this was a change in the role of the federal government, which had traditionally been concerned with increasing access to education rather than setting standards for the content of educational programming.54 2. funding special education and the complexity of disability evaluations realizing that idea created an expensive compliance burden for states, congress incorporated a partial funding mechanism into the legislation.55 this federal aid would not compensate for all the costs of compliance but it was hoped that the money would ease the burden of providing evaluations and new programs and make districts more willing to change organizational routines and attitudes. as a result, schools receive special education funding in proportion to the number of children identified with disabilities.56 linking funding to the labeling process, however, does not give schools the additional incentive to make sure services are appropriate. a common criticism of special education is that labeling drives the services. that is to say, a school’s access to funding affects a child’s eligibility and placement recommendations. there is a disincentive to provide for new disabilities because each new category dilutes the funding available to existing programs. these circumstances have led many advocates to argue for the separation of funding from the evaluation process. even if this were to occur, however, other issues remain problematic. for instance, states have had widely divergent standards of whom and what defines a given disability. in 1977, “thirty states had definitions of mental retardation inconsistent with the [idea] definition.”57 even if a district has a broad definition of eligibility, under-referrals may result from a backup in the assessment process, overcrowding of programs, or personality traits.58 to clarify the latter, if a child is not disrupting the class, a teacher may not realize he or she is having difficulty. one way to mitigate under-referrals is to increase special education training among regular classroom teachers. this may or may not lead to the opposite problem of over-referrals. referring children too often results when teachers are at their wits’ end with disruptive students. 3. competing interests despite valid criticisms, idea did provide funding, moral authority, a standard of free and appropriate education, and the leverage to ask for new 54. id. 55. see generally 20 u.s.c. § 1411 (2005). 56. 20 u.s.c. § 1411(a)(2)(b)(i) (2005). 57. clune & van pelt, supra note 42, at 18. 58. id. at 22-23. 348 indiana health law review [vol. 8:2 organizational procedures.59 idea offers a “demand entitlement” which can be used by those willing to request change.60 this change, however, depends on the given party’s resources to demand it. idea gives parents a litigation entitlement, as opposed to a clear entitlement of say $1,000 for a given disability. as a result, parents are limited by the cost of litigation yet not confined by a fixed voucher or categorical grant in a fluctuating economy. this pragmatic approach limits social change to balancing the competing economic and ethical interests of parents and schools. unfortunately, litigation entitlements have a number of disadvantages. first, legal goals do not consider the existing competition between priorities. second, legal remedies do little to address bureaucratic red tape or genuine technical ignorance. special education cannot have an unlimited budget, despite the current views of parents seeking to recover very large sums of money for private placements. schools will either attempt to balance special education provisions with those allocated to non-disabled children or they will resist accommodating special needs students because there is no pressure to do so or because the legal provisions are impossible to comply with, given budgetary constraints. third, legal objectives generally do not address the expense of compliance. as a result, districts opt for surface compliance. in assessing the merits of such compliance, however, it is important to realize the validity of the competing interests. the educational rights of non-disabled students, normal working hours, a teacher’s ability to teach effectively, and efficient use of taxpayers’ money are not discriminatory objectives. assessing them, however, does not necessarily mean giving them a higher priority than the needs of children with disabilities.61 4. an economic model for allocating special education services maximizing efficiency between two populations of children, those with disabilities and those without disabilities, is a function of schools and parents. in identifying a source of market failure in this context, this article focuses on maximizing the efficiency of education for all children. schools and parents become primary decision-makers, each of whom must maximize their objectives subject to their respective budgets. as rational decisionmakers, parents seek to maximize their utility. they do this by maximizing educational opportunity for their child(ren) given their budget constraints. similarly, as rational decision-makers, schools seek to maximize educational benefit across the two populations of children: those with regular educational needs and those with special needs. 59. see generally 20 u.s.c. § 1411 (2005). 60. clune & van pelt, supra note 42, at 39. 61. id. at 41. 2011] economic critiques of disability law 349 to what extent do parents have the right to shift their budget lines outward by requiring schools to finance services for their special needs child(ren)? idea mandates a free and appropriate education for all handicapped children, but what is appropriate? the analysis is complicated by the fact that some parties are seeking greater access for special needs students in regular classrooms while others are seeking a greater number of out-of-class services. in conducting a cost-benefit analysis for special education, parents must weigh the needs of their child(ren) against personal budget constraints and the opportunity cost of other personal needs. conversely, schools must analyze their opportunity cost of providing educational services to non-disabled children, given the externality of future cost to society of individuals with disabilities. what incentives do schools have to spend more money on special education now to save costs for other sectors of the society later? are funding patterns toward education efficient, given the crucial role human capital plays in our economy? should each student be competitive in getting a good job or simply able to obtain economic survival? is it the school’s responsibility to prepare all its students for higher education or should vocational training be the objective? must reading and spelling be mastered perfectly before pursuing abstract ideas? the answers to these kinds of questions greatly effect what are the perceived needs of a child. furthermore, perspectives on a child’s needs will vary depending on whether the school takes a short-term perspective of a school year or a long-term perspective of the life span of the special needs person. do the opposing goals of schools and parents create a paradox of compensation or can special education law create efficient incentives for both schools and parents? investing in education can reduce support cost later on. a given school, however, does not directly benefit from the costs that are saved in the individual’s adult years. therefore, there is a lack of local incentive to pay the price of benefits to other sectors of society in the future. as funding for education continues to decrease in relation to the demand for services, the controversy over resource allocation mounts.62 5. the rowley case hendrick hudson district board of education v. rowley63 provides a landmark judicial interpretation of the level of services that idea requires. the supreme court restrictively interpreted idea to require schools to provide merely “adequate” educational benefit.64 mr. and mrs. rowley 62. charles mccormick & patricia f. first, the cost of inclusion: educating students with special needs, 60 sch. bus. aff. 30, 30 (1994). 63. hendrick hudson district bd. of educ. v. rowley, 458 u.s. 176 (1982). 64. id. at 210. 350 indiana health law review [vol. 8:2 sought a sign-language aide for their daughter, amy.65 she had minimal residual hearing but was an excellent lipreader.66 as plaintiffs on amy’s behalf, her parents argued that refusing to provide amy with a sign language interpreter when she entered first grade was a denial of a “free appropriate public education” under idea.67 the court found that amy performed better than average in the class and was advancing easily from grade to grade, despite understanding less than half of what went on in the classroom.68 there was a clear disparity between amy’s actual achievement and potential. on these grounds, the district court decided that amy was not being provided a “free appropriate public education.”69 the court defined the latter as “an opportunity to achieve [her] full potential commensurate with the opportunity provided to other children.”70 the supreme court, however, disagreed with the lower court’s ruling that amy should be provided with a sign language interpreter.71 instead the court found that since she was receiving an “adequate” education, was performing above average work, and was receiving some personalized instruction and services the lower court should not have found that idea required anything further.72 in his dissent, justice white disagreed with the court’s conclusion that idea only mandated “adequate” educational benefit.73 he pointed out that congress did not intend courts to end all inquiry if a child is performing on grade level. in fact, congress repeatedly used the term “full” rather than anything that could be interpreted to mean “adequate.” as justice white explains, [t]he act itself announces it will provide a “full educational opportunity to all handicapped children” 20 u.s.c. § 1412(2)(a) (emphasis added). this goal is repeated throughout the legislative history, in statements too frequent to be “passing references and isolated phrases” . . . . congress wanted not only to bring handicapped children into the schoolhouse, but also to benefit them once they had entered.74 65. id. at 184. 66. id. at 184. 67. id. at 185. 68. id. 69. id. at 185-86. 70. id. at 186 (quoting rowley v. bd. of educ., 483 f. supp. 528, 534 (1980)). 71. id. at 210. 72. id. 73. id. at 215-20. 74. id. at 213. 2011] economic critiques of disability law 351 justice white goes on to criticize the majority opinion’s use of the parc and mills cases.75 he contends that, the fact that “these decisions served as an impetus for the act does not, however, establish them as the limits of the act.”76 allocating resources for special education appears to create a paradox of compensation. if the law requires that a child be afforded the maximum development possible then schools have an efficient incentive to identify and serve children with disabilities. parents, on the other hand, do not have efficient incentives. they do not have anything obligating them to make sure the cost of a service is offset by the benefit to their child. on the other hand, if the law only requires that “adequate” educational services which offer merely “some” educational benefit be afforded to a special needs child, then parents are the ones who have efficient incentives to find out what services are essential. schools, on the other hand, do not have efficient incentives to provide services beyond the first increment of educational benefit. the incentive on the part of schools to provide as little as possible, is what concerned justice white in the rowley case and has led several states to establish standards above the rowley precedent of “adequate” educational benefit.77 the following section seeks to strike a balance between educationally beneficial services and those ensuring maximum possible development. 6. proportional quality idea requires that every child has a right to a free and appropriate education in the least restrictive setting possible.78 yet, interpreting these provisions can be confusing. for example, does a child have access to special education if there is a testable disparity between achievement and potential, or merely if that disparity is below grade level (i.e., the underlying issue in the rowley case)? a general misunderstanding of disabilities aggravates such complexities. disabling conditions do not preclude students from performing above grade level. in fact, it has been estimated that one sixth of the population of gifted children have disabilities.79 75. id. at 215-20. 76. id. at 214. 77. see id. 78. “each public agency must ensure that—(i) to the maximum extent appropriate, children with disabilities, including children in public or private institutions or other care facilities, are educated with children who are nondisabled; and (ii) special classes, separate schooling or other removal of children with disabilities from the regular educational environment occurs only if the nature or severity of the disability is such that education in regular classes with the use of supplementary aids and services cannot be achieved satisfactorily.” 20 u.s.c. §300.114(a)(2). 79. linda kreger silverman, gifted and talented students, in special education & student disability, an introduction: traditional, emerging, and alternative perspectives 377, 408 (edward l. meyen & thomas m. skrtic eds., 1995). 352 indiana health law review [vol. 8:2 currently, enormous but inadequate amounts of money are being invested in special education. these funds undoubtedly help a large number of children. it is important, however, to make sure the value of a service to a given child is greater than the cost of the service. this is not synonymous with determining that the value to the child is greater than the value of an alternative resource to non-disabled children. for example, if an aide for a special needs child can only be afforded at the expense of a classroom chalkboard, it makes sense to ensure that the benefit of an aide to the child with a disability justifies the cost of the aid. while administrative biases and discrepancies in defining value (i.e., economic productivity verses individual dignity) can make the benefit hard to calculate, it is clear that the service should be worthwhile to its recipient. in contrast, determining whether the special needs child can use the aide more productively than the other students can use the chalkboard legitimizes replacing the rights of less highly valued individuals with the rights of more highly valued individuals. to give up something in the present in order to receive something greater in the future may be efficient. to require one group of children to sacrifice something so that another group can have something, even if the gain is greater than the loss, is not efficient. pareto efficiency requires that the party not being made better off is at least not made worse off.80 unlike a strict cost-benefit analysis, proportional quality programming does not compare services on the basis of goals but rather sees each group of children as having entitlements to the same degree of respect and a right to learn. while it is unrealistic not to consider costs in determining special education services within a system that is forced to weigh the costs and benefits of every other aspect of its program, the issue of cost should be confronted directly, not disguised under the educational term “least restrictive environment.” cost considerations must be made on a quality basis. if schools only compare costs, they will continue to systematically deny special education programs on the basis of higher cost. if sacrifices must be made, they should be made across the board instead of always being made by a single group of students. therefore, before costs are used to legitimize not providing an educationally beneficial special service, schools have to offer special needs students a program that is comparable in quality to the program available to non-disabled students.81 a proportional quality approach can narrow the discrepancy between the nondiscriminatory mandate of section 504 and the affirmative requirements imposed by idea. a child with a disability must be able to benefit 80. pareto efficiency or pareto optimality “occurs when resources are so allocated that it is not possible to make anyone better off without making someone else worse off.” see oecd, glossary of statistical terms, http://stats.oecd.org/glossary/detail.asp?id=3275 (last visited 05/31/11). 81. bartlett, supra note 47, at 9. 2011] economic critiques of disability law 353 from the instruction under idea. section 504, on the other hand, merely requires that a handicapped child be offered the same educational access as a non-disabled child. additionally, section 504’s protection does not bring money with it. federal funding determines whether section 504 is applicable but the money does not have to be disability funding. section 504 is a civil rights law rather than a funding law. while idea provides more detailed provisions for those who qualify, section 504 extends to a range of individuals with disabilities who are not protected under idea. many college students, for example, find that the accommodations that they received throughout elementary and secondary school are no longer protected in post-secondary pursuits since idea only covers individuals with disabilities up to the age of twenty-one. 82 the following discussion focuses on the struggle that post-secondary students have experienced. d. an “otherwise qualified individual” under section 504 one of the greatest obstacles that post-secondary students have faced pursuant to section 504 of the rehabilitation act, has been to successfully argue that they are an “otherwise qualified individual with a disability.” southeastern community college v. davis83 was the first case to interpret the meaning of this phrase under the rehabilitation act. in davis, a woman with a hearing impairment brought suit under section 504 after being denied admission to a clinical nurse-training program.84 the district court entered a judgment for the university, concluding that davis’s handicap would prevent her from safely participating in the training program.85 the court of appeals for the fourth circuit reversed, based on the finding that southeastern had to evaluate the plaintiff’s credentials without considering any limitation that would result from her handicap.86 the supreme court rejected the court of appeal’s reasoning and held that “[a]n otherwise qualified person is one who is able to meet all of a program’s requirements in spite of his handicap.”87 furthermore the court concluded that, [the] respondent could not participate in southeastern’s nursing program unless the standards were substantially lowered. section 504 imposes no requirement upon an educational institution to lower 82. idea, pub. l. no. 101-476, 104 stat. 1142 (codified at 20 u.s.c. §§1400-1482 (2006)). 83. southeastern cmty. college v. davis, 442 u.s. 397 (1979). 84. id. at 400. 85. id. at 402-03. 86. id. at 404. 87. id. at 406 (emphasis added). 354 indiana health law review [vol. 8:2 or effect substantial modifications of standards to accommodate a handicapped person.88 davis allowed educational institutions to merely demonstrate a rational basis for denying admission on the basis of disability. a university was not required to make any “reasonable accommodations” to permit a student with a disability to participate. the supreme court did not establish the “reasonable accommodations” standard until 1985. alexander v. choate89 called for the supreme court to review its earlier holding in davis. in alexander v. choate, the court concluded that, “while a grantee need not be required to make ‘fundamental’ or ‘substantial’ modifications to accommodate the handicapped, it may be required to make ‘reasonable’ ones”90 the court also altered its previous holding in davis with regard to the term “otherwise qualified.”91 in davis, an individual was not “otherwise qualified” unless he or she was able to meet all of a program’s requirements in spite of a disability.92 in alexander v. choate, on the other hand, an individual could still be “otherwise qualified” even if he or she required “reasonable accommodations” to meet all of a program’s requirements.93 while alexander v. choate concerned a medical policy rather than a post-secondary context, it did substantially affect the analysis regarding students seeking accommodations for disabilities.94 reasonable accommodations can be difficult to determine. hidden disabilities, such as dyslexia, have proven to be particularly controversial. the court of appeals for the first circuit sought to provide a clearer interpretation of the alexander v. choate reasonable accommodation requirement in wynne v. tufts university school of medicine95 by establishing the following standard: if the institution submits undisputed facts demonstrating that the relevant officials within the institution considered alternative means, their feasibility, cost and effect on the academic program, and came to a ra 88. id. at 413. 89. alexander v. choate, 469 u.s. 287 (1985). 90. id. at 300 (finding tennessee’s medical policy, which limited the number of covered hospital days, did not violate section 504 since a policy that has a disparate impact on individuals with disabilities does not necessarily create a prima facie case of discrimination under the rehabilitation act). 91. id. at 301. 92. davis, 442 u.s. at 406 (emphasis added). 93. alexander, 469 u.s. at 301. 94. robert w. edwards, the rights of students with learning disabilities and the responsibilities of institutions of higher education under the americans with disabilities act, 2 j.l. & pol’y 213, 227 (1994). 95. wynne v. tufts unv. sch. of med., 976 f.2d 791 (1st cir. 1992). 2011] economic critiques of disability law 355 tionally justifiable conclusion that the available alternatives would result either in lowering academic standards or requiring substantial program alteration, the court could rule as a matter of law that the institution had met its duty of seeking reasonable accommodation.96 wynne argued that he failed several first year medical classes as a result of having dyslexia and that, therefore, the university discriminated against him in not modifying the standard multiple-choice exams to accommodate his learning disability.97 the court deferred to the university’s academic judgment that modifying multiple-choice examinations did not constitute a reasonable accommodation.98 while the court ultimately decided in favor of the university, the case did clarify the notion that a university must fully defend its grounds for revoking admission of a student with a disability. the interpretive guidelines for the ada, drafted by the department of justice (“doj”) and equal employment opportunity commission (“eeoc”) point out that, given the similarities between section 504 and the ada, many of the statutory interpretations of section 504 can be used in evaluating the ada.99 therefore, the decisions made in davis, alexander, and wynne may apply to the ada as well. iv. the americans with disabilities act of 1990 the purpose of the ada is “to provide a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities.”100 perhaps the greatest achievement of the ada is its extension of disability rights to the private sector. this corrected a fundamental flaw in the government’s efforts to bring people with disabilities into mainstream society—a goal that section 504’s limited scope was inherently unable to achieve. as john j. sarno points out, the primary intent of the ada is to eradicate day-today discrimination against persons with disabilities. the ada represents an attempt to legislate comprehensive social policy by barring attitudinal as well as environmental barriers. such an effort demonstrates a society working to transform itself by striking a bal 96. id. at 793 (quoting wynne v. tufts unv. sch. of med., 932 f.2d 19 (1st cir. 1991)). 97. id. at 792. 98. id. at 795. 99. h.r. rep. no. 101-485, pt. 2, at 53-55 (1990). 100. 42 u.s.c. § 12101(b)(1) (2010). 356 indiana health law review [vol. 8:2 ance between the morality of the marketplace and the imperative of equal opportunity.101 in contrast, critics of the ada see it as an effort on the part of congress simply to privatize the expense of accommodating people with disabilities.102 a. administrative and judicial enforcement it is important to ensure not only a strong, well-funded, and capable infrastructure to enforce the ada, but also a staff knowledgeable and supportive of its statutory goal of eliminating discrimination against individuals with disabilities. ultimately, neither congress nor the judiciary is capable of legislating a change in attitudes towards people with disabilities. laura rothstein notes that institutions of “[h]igher education had evolved practices, policies, and procedures before other sectors affected by the ada (with the exception of k-12 education).”103 society-wide, integration is at best a precursor to acceptance. it is not acceptance itself. carrie basas notes that, “the daily struggle of managing other people’s reactions to and stereotypes about disability can become a job in itself.”104 she goes on to point out that, when “reasonable accommodation” is bandied about, minds ultimately turn to a list of tangible tools, equipment, and changes in the physical environment such as large-screen monitors, curb cuts, automatic doors . . . . without considering the combined effects of impairments, the cultural weight of disability, and the long-term impact of societal inaccessibility.105 enforcement of established civil rights and clear guidelines as to what those rights entail are essential to eliminate discrimination. the legislature must adequately fund and staff enforcement entities. this legislative approach, however, is not always sufficient in confronting the problem of clarifying 101. john j. sarno, the americans with disabilities act: federal mandate to create an integrated society, 17 seton hall legis. j. 401, 405 (1993). 102. id. at 412. 103. rothstein, supra note 6, at 863 (noting that, “colleges and universities also followed the admonition in southeastern community college v. davis that: ‘technological advances can be expected to enhance opportunities to rehabilitate the handicapped or otherwise to qualify them for some useful employment. such advances also may enable attainment of these goals without imposing undue financial and administrative burdens upon a state.’”). 104. carrie griffin basas, the new boys: women with disabilities and the legal profession, 25 berkeley j. gender l. & just. 32, 57 (2010). 105. id. at 60-61. 2011] economic critiques of disability law 357 the language of the ada. courts must play the important role of making statutory interpretations that are consistent with the legislative intent of eradicating discrimination. assessing the ada depends, in part, on what one interprets its mandate to be. thus far, however, a great deal of the ada analysis has remained at the initial level of determining whether the individual can even qualify as having a “disability.” one area in which this has been difficult has been for post-secondary students with learning disabilities. as wendy hensel notes, [t]he problem for most students in higher education, particularly those in graduate or professional school, is that they have attained a level of educational achievement which surpasses the majority of americans. some large cities have nearly 50% of their students drop out of high school with no diploma, and nationally less than one-third of all adults attain college degrees. there is abundant evidence that the average person cannot read at a high school level, let alone at a collegiate one.106 the following case exemplifies the ongoing struggle that law students continue to face with regard to seeking reasonable accommodations on bar examinations. b. the bartlett case in bartlett v. new york state board of law examiners,107 despite being given extra time throughout law school, on the multistate professional responsibility examination and on the pennsylvania bar examination, the new york state board of law examiners repeatedly denied dr. bartlett’s applications for accommodations based upon a learning disability.108 individuals with learning disabilities often have a difficult time conveying their skills on standardized tests that are timed, yet, new york bar board member laura taylor swain testified that the bar examination is not intended to measure the ability to work under time constraints.109 rather, the board assumes that there is sufficient time for the average person to answer the questions.110 in fact, the board has never attempted to determine 106. wendy f. hensel, rights resurgence: the impact of the ada amendments act on schools and universities, 25 ga. st. u. l. rev. 641, 672 (2009). 107. bartlett v. n.y. state bd. of law exam’rs, 970 f. supp. 1094 (s.d.n.y. 1997). 108. id. at 1101-04. 109. id. at 1130. 110. id. at 1130-31. 358 indiana health law review [vol. 8:2 what reading speed is needed under standard conditions.111 instead they assume that there is enough time for most people.112 the united states district court for the southern district of new york found that a reading disorder cannot be assessed solely by the woodcock reading mastery test (“wrmt”), a standardized test of reading mastery, since it does not make distinctions between rates of automaticity, nor does it measure the ability to recognize and read a word with fluency.113 furthermore, the wrmt was created to test children and does not have a sufficient number of difficult questions for the average adult.114 most importantly, since the wrmt is not a timed test, it is incapable of measuring how slowly someone reads, which is a significant component of diagnosing an adult with dyslexia.115 the court of appeals agreed with the district court that dr. bartlett does have a disability pursuant to the ada and the rehabilitation act.116 yet, the court of appeals held that the district court erred in going as so far as to find whether dr. bartlett had a disability with regard to her ability to “work” since the district court could have concluded that she has a disability that substantially limits her major life activities of “reading” and “learning.”117 given her reading and learning disability, the court of appeals held that the district court’s ultimate conclusion, that dr. bartlett requires reasonable accommodations, was correct.118 a person has a disability under the ada and section 504 of the rehabilitation act if, he or she has “a physical or mental impairment that sub 111. id. at 1131. 112. id. at 1130-31. in 1992 the new york court of appeals commissioned a study called, an evaluation of the new york state bar examination. otherwise known and the millman report, this study was released in may of 1993. it found that the bar exam tested only legal knowledge, legal reasoning, and legal ability. the millman report did not assess the impact of time pressure. instead the panel of experts who measured content validity found that speed should not be a major component of the examination. jason millman et al., an evaluation of the new york state bar examination (1993). this supports the district court's rejection of the board’s claim that the bar examination was intended to be a reading test in the bartlett case. the district court found that “speed in reading is not tested by the bar examination, nor is speed in reading one of the essential functions of lawyering.” bartlett, 970 f.supp. at 1128. the court held that the board was “estopped from arguing that the bar examination is intended to test either reading or the ability to perform tasks under time constraints.” id. in reaching this conclusion, the court pointed out that “numerous accommodations, including time extensions are granted every year to persons whose physical impairments make it difficult visually to read, including persons who are blind.” id. at 1130. the simple fact that there are blind members of the bar indicates that the bar examination does not require a visual ability to read. 113. id. at 1114. 114. id. 115. id. at 1112. 116. bartlett v. n.y. state bd. of law exam’rs, 156 f.3d 321 (2d cir. 1998). 117. id. at 329. 118. id. at 327. 2011] economic critiques of disability law 359 stantially limits one or more [of the] major life activities.”119 while neither of these statutes defines this language, congress authorized the eeoc to issue regulations regarding discrimination in the workplace under title i of the ada.120 congress authorized the doj to issue interpretive guidelines regarding discrimination in public and private service organizations under titles ii and iii of the ada.121 dr. bartlett brought suit against the board as a public licensing entity pursuant to title ii of the ada.122 she argued that she had an impairment that substantially limited her major life activities of “learning,” “reading” and “working.”123 the doj’s regulations defining “physical or mental impairment” pursuant to title ii of the ada include “specific learning disabilities.”124 furthermore, these regulations define “major life activities” as expressly including “learning and working.”125 title ii regulations do not clarify the meaning of “substantially limits,” but the doj has said to look to titles i and iii in interpreting title ii, as long as these provisions are not inconsistent with the rehabilitation act regulations.126 the second circuit held that self-accommodating measures employed by bartlett should not be considered when determining whether she was substantially limited in a major life activity.127 given the supreme court’s decision in sutton that mitigating measures should be part of a substantially limited determination, the case was remanded to the district court.128 the district court held that bartlett was not substantially limited given her selfaccommodation measures.129 the second circuit disagreed for a second time, finding that average skills on some measures did not offset below average skills on other measures when the latter substantially limited her ability to read.130 slow reading speed could be distinguished from wearing contact lenses, which is what the district court used as a comparison.131 119. 42 u.s.c. § 12101(1)(a) (2009); see also 29 u.s.c. § 706(9) (2010). 120. 42 u.s.c. § 12116 (2006). 121. 42 u.s.c. § 12134(a) (2006) (title ii, subtitle a); 42 u.s.c. § 12186(b) (2006) (title iii). 122. see 42 u.s.c. § 12132 (2006). 123. bartlett, 156 f.3d at 328. 124. 28 c.f.r. § 35.104 (2011) (disability). 125. id. 126. 28 c.f.r. § 35.103(a) (2011). 127. bartlett v. n.y. state bd. of law exam’rs., 226 f.3d 69, 74 (2d cir. 2000). 128. id. 129. bartlett v. n.y. state bd. of law exam'rs, no. 93 civ. 4986(ss), 2001 wl 930792, at *1 (s.d.n.y. aug. 15, 2001). 130. bartlett, 226 f.3d at 81. 131. id. 360 indiana health law review [vol. 8:2 v. recommendations the legal community should promote the understanding that lawyering is just as much about coming up with creative legal arguments as it is about being able to read quickly. the real question should be whether the person who wishes to be a lawyer has the analytical and creative skills to contribute to the profession. we do not ask people whether they can walk the fifteen miles it might take to get to work each morning. we recognize that with the use of a car they can arrive at work on time. frequently, disabilities can be reasonably accommodated. yet, it remains to be seen how broadly the judicial system will be willing to interpret congress’s mandate.132 finding that bartlett does not read at the level of an average person is similar to justice white’s dissent in rowley. in rowley, justice white used the mills finding to argue that providing amy with an equal educational opportunity would require an interpreter since, in comparison to her classmates, she could only understand half of what was going on in the classroom.133 having a ph.d. and a j.d. would generally be considered to be above average, yet in the same way justice white broke rowley’s disability into its component parts, the court of appeals in bartlett concluded that dr. bartlett’s impairments in automaticity and phonological processing cause a substantial limitation to a major life activity. reasonable accommodation of a learning disability offers a useful sliver of the disability debate with which to assess the powerful role that the adaaa can play in restoring the civil rights of people with disabilities. the adaaa’s clarification of definitions applies to both the ada and to the rehabilitation act giving students generally and law students with learning disabilities in particular clear rights to reasonable accommodations that help them read, concentrate, and learn. while the adaaa did not need to strengthen “reasonable accommodation” language under the ada since it was already a very comprehensive framework, this article recommends that federal disability legislation’s broad “reasonable accommodation” provisions be implemented without further delay. 132. alex b. long, introducing the new and improved americans with disabilities act: assessing the ada amendments act of 2008, 103 nw. u. l. rev. colloquy 217, 228 (2008) (noting that, “[u]nfortunately, congress has done little to assist courts in devising a clearer standard regarding what qualifies as a ‘reasonable’ accommodation. the original version of the ada did little to define the concept, leaving it to the courts to flesh out its contours. unfortunately, the few times the supreme court has addressed the concept of reasonable accommodation or reasonable modification, the cases have been so fact specific as to provide little guidance for future cases.”); see also conference panel, what the ada amendments and higher education acts mean for law schools, 18 am. u. j. gender soc. pol'y & l. 13 (2009) [hereinafter conference panel]. 133. hendrick hudson district bd. of educ. v. rowley, 458 u.s. 176, 193 (1982). 2011] economic critiques of disability law 361 litigation may turn on nuanced hardship analyses134 but general recognition should be forthcoming that, as the eeoc explains, “most accommodations can be provided at little or no cost.”135 mastroianni goes on to address the important role of law schools in following through on the ada’s mandate: i think it's important for us to take a step back and look at how wrong the united states supreme court and the lower federal courts were in interpreting this law. what are we not getting across in legal education that’s enabling judges and enabling attorneys who are working with these laws to understand that, yes, the definition of “disability” is broad; that yes, it’s a remedial civil rights statute and it should be interpreted broadly.136 i recommend that legal education emphasize the acquisition of critical thinking skills and the effectiveness of a combination of superior intellect, judgment, dedication, and interpersonal skills in serving society. part of this paradigm shift involves achieving a broader recognition of assistive technology and other reasonable accommodations as well as recognition of leaders in the legal profession who have disabilities. the national association of law students with disabilities has begun establishing mentoring and networking communities.137 existing networks of all stripes can help support the disability community to thrive in a legal arena. disability is a cross-cutting issue that can and should be considered with regard to infrastructure, assistive technology, and educational theory. recognizing that universal design can optimize learning and assessment across an entire learning community can lead to increasing small group interaction, take-home assignments, and a range of multi-sensory teaching approaches. computers have allowed many attorneys with disabilities to work independently, reducing the need to request accommodations. for others it is still important to obtain extended exam and assignment time, interpreters, texts in an alternate format, etc. beyond task-based accommodations, individual law schools, the american bar association (“aba”), and the american association of law schools (“aals”) can collectively 134. conference panel, supra note 132, at 30. 135. u.s. equal employment opportunity commission, reasonable accommodations for people with disabilities, eeoc, www.eeoc.gov/facts/accommodations-attorneys.html (last visited feb. 2, 2011); see also donald h. stone, the disabled lawyers have arrived; have they been welcomed with open arms into the profession? an empirical study of the disabled lawyer, 27 law & ineq. 93, 103 (2009). 136. conference panel, supra note 132, at 24. 137. id. at 26. 362 indiana health law review [vol. 8:2 play a powerful role in supporting the establishment and linkage of disability support and advocacy communities. my recommendation, as courts begin to balance reasonable accommodations vis-a-vis academic and licensing standards under the adaaa,138 is to implement best practices that maximize optimal learning and assessment conditions for everyone. while cost is a concern to legal and professional institutions alike, equity and efficiency can be balanced through broad implementation of requisite reasonable accommodations pursuant to federal disability legislation. vi. conclusion in the over three decades since the passage of the rehabilitation act in 1973 we have come a long way in ensuring that the civil rights of people with disabilities are respected. given the lag time between passing such laws as the ada and having them effectively implemented, the law is still in it’s infancy in coming to terms with recognizing civil rights on the basis of disability. we have a great deal of work yet to do to embrace individuals who have disabilities on a participatory level. idea did succeed in ending the exclusion of students with disabilities from public school, providing a range of special education programs, and giving schools incentives to increase their provisions for children with disabilities. in return for complying with federal statutory mandates, congress provides states with partial funding. therefore, if states offer special education services within certain specifications, they can receive federal aid. while this has helped schools create programs, it has also distorted the identification process. as a result, the labeling process sometimes drives services. separating special education services from funding mechanisms, however, would dismantle the equilibrium of incentives. if idea were not funded, schools would have inefficient incentives to provide services. that is to say, schools would have a strong incentive to avoid identifying students with disabilities. if idea were fully funded, however, there would be no incentive to make sure the costs of the service were worthwhile to the 138. jenkins v. nat’l bd. of med. exam’rs, no. 08-5371, 2009 wl 331638 (6th cir. feb. 11, 2009) (detailing how plaintiff, a third-year medical student, was diagnosed with a reading disorder early in life and had received accommodations throughout his academic career). the jenkins case did not resolve the balancing between academic standards and reasonable accommodations. see also hensel, supra note 106, at 672, 684 (noting further that, “[t]he adaaa will undoubtedly expand eligibility for students with disabilities in elementary and secondary school seeking accommodations pursuant to § 504 of the rehabilitation act. this may prove to be problematic for schools, particularly in the context of children with learning disabilities. the newly liberal § 504 eligibility standards are in tension with the restrictive threshold interpretation that some courts and administrative hearing officers have given to learning disabilities under idea. this conflict has the potential to result in confusion for administrators and the inconsistent treatment of similarly situated children.”). 2011] economic critiques of disability law 363 special needs child. in this way, idea enables change by providing new resources, but the change is bound by the limitations of these resources. if enough states increase the standard of educational services provided to children with disabilities, then the supreme court may overturn the rowley precedent. the paradox of compensation, however, illustrates that the latter would simply reverse incentives—still leaving one party with the incentive to be inefficient in analyzing the costs and benefits of providing special education services. proportional quality programming, on the other hand, can alleviate the tension created by establishing individualized rights for one disadvantaged group by evaluating those rights in relation to legitimate goals of the system in which those rights must be provided. the success of a quality approach, however, depends on decision-makers’ ability to remain committed to establishing protective rights for special needs children without allowing these rights to preempt those of non-disabled children. in this way, we can go beyond simply allowing every child to occupy a chair in the classroom to providing each child the opportunity to learn. what happens, however, when students who are over the age of twenty-one try to request accommodations in undergraduate and graduate programs? higher education is becoming an essential credential in a competitive market place. idea, however, no longer protects these students’ rights to special accommodations. ultimately, individual biases cannot be eliminated through legislation. however, when those personal misconceptions affect an individual’s ability to pursue their legal right to equal education and access to professional entrance examinations, then it is society’s responsibility to end such institutionalized discrimination. in our society, we need to recognize how dangerous it is to set aside individuals who are unable to conform to a given mold no matter how economically or socially efficient restricted access may appear. in rawls’ theory of justice, individuals are put in a room without knowing where in society they would return.139 they are deprived of a sense of history and thus do not know whether they were a minority group in the past or will be so in the future. this veil of ignorance takes away all cultural and historical perspective. rawls first tenet, that there would be a maximum level of liberty, would ensure that each person has as much liberty as possible as long as everyone else has the same level of liberty. his second tenet that social and economic inequalities would be arranged in accordance with the greatest benefit of the least advantaged and that positions would be open to all ensures equal opportunity. in predicting what maxims people would create for society, rawls points out that no one would want to be on the bottom.140 people would decide to make everyone equal—thus, maximizing the bene 139. rawls, supra note 11. 140. id. 364 indiana health law review [vol. 8:2 fit of the least advantaged in order to raise them up to the same level as those who are already advantaged. while rawls does not provide a historical account of how people have gone about protecting civil rights, his theory of justice provides a useful philosophical rational for granting such rights. like any model, there are problems with thinking that reality will correspond perfectly with such a hypothetical state of society. lack of exposure and understanding of disabilities in general can skew people’s commitment to providing a sufficient safety net in the area of disability protection. a substantial body of litigation provides evidence of this lack of commitment. furthermore, there are some disabilities to which people do not believe they would be susceptible. ignorance and irrational discounting of personal risk can lead to an insufficient level of disability protection. there are disabilities that tend not to develop until later in a person’s life. despite the fact that learning disabilities can result from severe head injuries, people who do not already have a learning disability generally do not believe that they are susceptible to such a condition. thus, applying rawls decision-making model to accommodating the needs of people with learning disabilities may not work as well as applying the theory to accommodating a condition to which people feel more susceptible. the scenario is complicated by the level of ignorance about the hidden nature of learning disabilities vis-a-vis the more obvious needs of someone who uses a wheel chair. reality appears to only reflect half of a rawlsian model. while we do not know what will occur in the future, we are not blind to the past or to present hierarchies of physical and mental aptitude. nor do we set aside the existing distribution of wealth when deciding whether to pay for civil rights measures for people with disabilities. within this middle ground lies a substantial opportunity to carry out the full intent of congress in passing federal disability legislation. now that we have clarified a broad civil rights approach, the legal community can move on to helping individuals with disabilities obtain reasonable accommodations. jeremy coylewright jeremy coylewright is currently a 2nd year medical student at johns hopkins school of medicine in baltimore, maryland, where he lives with his wife, megan, a 2nd year osler internal medicine resident, and his two children, izaia and indigo, ages 7 and 4. he is a graduate of the university ofmaryland school of law (order of the coif, 2005), where he focused on health care law and policy issues, and was awarded the 2005 larry b. shoda award and the 2005 joseph bernstein award for significant legal writing: ''new strategies for prisoner rehabilitation in the american criminal justice system: prisoner facilitated mediation," published in the journal of health care law and policy, vol. 7, no. 2. to bridge his medical and legal training, he plans to serve as a physician in the prison environment and work with legislators and administrators as a resource for the maintenance of prisoner health and rehabilitation in the correctional setting. jeremy's father, lewis elden wright, m.d., graduated from the indiana university school of medicine in 1969. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i no fault, no worries ••• combining a no-fault medical malpractice act wim a national single­ payer iiealm insurance plan jeremy coylewright" table of contents i. introduction ................................................................................. 32 ii. the u.s. health care crisis: inadequate health coverage and the f allure of the medical malpractice liability system ................................................... 33 a. inadequate health care coverage ............................................. 33 b. the failure of the american medical malpractice liability system .......................................................................... 36 ill the optimal american health care system: overlapping health interests between patients and providers ............................................................... 40 iv. discussing the alternatives: universal health care and medical malpractice liability reform in the american health care system ..................................... .42 a. tort reform: from alternative dispute resolution to arm-wrestling ...................................................... 42 b. universally undercovered: the push for universal health care in america ............................................................. 46 c. the physicians' working group proposal for single-payer national health insurance: "[the] [p]ursuit of corporate profit and personal fortune have no place in care-giving. " ..................................... .48 v. the combination of a no-fault medical malpractice compensation act with a national single-payer health insurance plan .................... 51 a. the patient's perspective on medical malpractice liability reform ......................................................................... 52 b. the provider's perspective on a national single-payer system of health care .......................................... 52 * m.d. candidate, 2009, johns hopkins school of medicine, baltimore, maryland; j.d., 2005, university of maryland school oflaw, baltimore, maryland; b.s., 1998, university ofwisconsin, madison, wisconsin. i wish to give thanks to my loving parlner, children, fiunily, and friends for their constant love and support. i also wish to give a special acknowledgment to my father, lewis elden wright. m.d. (1944-1999), a graduate of the indiana university school of medicine (1969) and a powerful role model for me, both as a parent and as a health care provider. 32 indiana realm law review c. the proposal: combining a no-fault medical malpractice compensation act with a [vol. 4:29 national single-payer health insurance plan ........................... 53 d. how patients will benefit from the proposal ............................ 53 e. how providers will benefit from the proposa/ •......................... 54 vi. conclusion: a recommendation of revolutionary implementation: moving forward with a dual poucy approach .•••••..••....••••.•.•..•...•.•..•• 55 a. mobilizing the patient and provider communities to the same side of the health care reform debate ................. 55 b. establishing the necessary links in the academic, public health, governmental, and administrative communities ...................................................... 56 c. preparing an early counterattack against the insurance lobbyists and the trial lawyers ............................... 56 d. a"anging a simple yet appropriate and effective marketing strategy ..................................................................... 56 e. obtaining grassroots support and excellent movement leadership efforts .................................................... 57 1 in1roduction the united states faces an escalating health care crisis characterized by uncontrolled and inequitable health care expenditures, a growing body of over forty-three million uninsured citizens, and a system of medical malpractice li­ ability that drives up insurance costs, frustrates providers, and provides little reliefto injured patients. while diverse interest groups champion the cause of universal health care, others press for immediate tort reform. ultimately, re­ form in each of these areas is needed to improve the health of the nation. a broad plan, coupling a universal system of national single-payer health insur­ ance1 with a no-fault system of medical malpractice compensation, may provide the necessary bridge to bring the champions of universal health care and tort reform together in the interests of establishing the best possible system ofhealth care in the world. 1 for a simple background primer for single-payer and other health care finance models, see, e.g., pras.hant tamaskar & josh rising, am. men. s1udent ass'n, theoretical models for deuvering unnersal health care: an analysis of important concepts 2 (2003),availableathttp://www.amsa.orglpdfi'model.pdf(''[a]singlepayerhealth-caresystemis one in which the medical costs of the citizens of a nation are financed by one source, usually the federal government."). while discussion of the myriad of single-payer health insurance models will not be covered here, the model proposed in this piece and advocated for by this author is consistent with that of the 2003 physicians' working group for single-payer national health insurance. proposal of the physicians' working group for single-payer national health in­ surance, 290 j. am. med. ass'n 798,803 (2003) [hereinafter physicians' working group]. 2007] no-fault medical malpractice & single-payer health insurance 33 this article takes the position that a dual health care policy approach cou­ pling universal health care and tort reform is necessary to effectively repair the american health care system. part ii of this paper begins with a description of the health care crisis in the united states, both in terms of the devastating ef­ fects of inadequate health care coverage and the failure of the medical malprac­ tice liability system. part m describes the optimal health care goals for two of the health system's most important players: patients and providers. part iv dis­ cusses several of the proposed options for both medical malpractice liability reform and the establishment of universal access to health care. part v pro­ poses that effective health care reform can be achieved by combining a no-fault medical malpractice compensation act with a national single-payer health insur­ ance plan. part vi concludes by suggesting the next steps that must be taken to implement this dual policy approach and stresses the importance ofbridging the gap between patients and providers in their advocacy for the best possible sys­ tem ofhealth care in the united states. ii. the u.s. health care crisis: inadequate health coverage and the f allure of the medical malpractice liability system the u.s. health care crisis reflects itself on two fronts: a) in the inade­ quate health care coverage it provides despite some of the highest health care expenditures in the world and b) in the failure of the american legal system to adequately address the health care needs of injured patients through the medical malpractice liability system. a. inadequate health care coverage the vast number of americans without health insurance threatens not only those individuals without access to quality health care but also impacts the economic security and public health of the nation as a whole. more than forty­ three million americans are without health insurance today, which is nearly one in six persons.2 yet the united states spends more on health care than any other industrialized nation in the world, spending 15.3% of its gross domestic product ("gdp") on health-related expenditures, or on average, an expenditure of$6, 102 per citizen.3 with so many uninsured citizens in a nation offering the 2 inst.ofmed.,insuringameluca'shealtii: principles and recommendations 1 (2004), available at http://www.iom.edu/object.file/master/17 n32/uninsured6-english final.pdf[hereinafter inst. ofmed., principles and recommendations). forty-three mil­ lion uninsured represents the total population of twenty-six states combined. id. see also kaiser comm'n on medicaid & the uninsured, the henry j. kaiserf amily found., the uninsured: a primer: key facts about americans witiiout heal til insurance 1 (2006) [hereinafter kaiser, the uninsured] ("over 45 million americans under age 65 lacked health insurance coverage in 2004 .... "). 3 compare the united kingdom. which spends 8.1 o/o of its odp on health care expenses 34 indiana heal til law review [vol. 4:29 highest levels of medical technology and expertise in the world these expendi­ tures are not distributed equally amongst citizens. while some americans un­ doubtedly receive the highest standard of health care in the world, others live in relative health poverty, without effective health care access. health insurance remains simply unattainable for many families in the united states, regardless of their employment status.4 many citizens without health insurance work for employers that do not offer health coverage.5 for those employers that do offer coverage, it may still be unaffordable for working families. 6 non-employment related health insurance is even less affordable and may explain why most americans, specifically sixty-four percent, receive their health insurance through an employer.7 as a result, america has a high population of uninsured persons, and this ($2,317 per capita), canada, which spends 9 .90a. ($3, 165 per capita), france, at 10.5% ($3, 159 per capita), germany, at 10.6% ($3,043 per capita), mexico, at 6.5% ($662 per capita), and sweden, at 9.1% ($2,825 per capita). 0rg. for bcon. cooperation & dey., total expenditure on health: % gross domestic product (2006) available at http:/lwww.oecd.org/dataoecd/20/51 /37622205.xls. see also 0rg. for econ. cooperation & dev., total expenditure on health: per capita us$ purchasing powerp arity (2006)available at http://www.oecd.org /dataoecd/20/51/37622205.xls (click on relevant tab in the excel spreadsheet). note that despite the huge expense, the united states fares poorly in the health quality indicators of infant mortal­ ityandlifeexpectancy. seeorg.forbcon.cooperation&dev.,lifeexpectancyatbirth (2006), available at http://www.oecd.org/dataoecd/20/51137622205.xls (click on relevant tab in the excel spreadsheet); 0rg. for bcon. cooperation & dey., infant mortality deaths per 1000 live births (2006), available at http://www.oecd.org/dataoecd/20/51/37622205.xls (click on relevanttab in the excel spreadsheet). it has been argued that the united states would save over 2,000 additional babies a year if our infant mortality rate matched that of cuba. nicholas d. kristof, op-ed., health care? ask cuba, n.y. times, jan. 12, 2005, at a21 (arguing that universal health care coupled with the public health focus in the cuban national health care system likely results in better infant mortality rates). 4 kaiser, the uninsured, supra note 2, at 4 (stating that approximately seventy per­ cent of uninsured individuals are either full-time workers or dependants). inst. of med., uninsurance facts & figures: healthinsuranceis0utoffinancialreachformostof the uninsured 1 (2004), available at http://www.iom.edu/object.file/master/17/ 744/0.pdf [hereinafter inst. of med., health insurance out of reach) ( "unaffordability is the top reason uninsured adults give for being without coverage."). an additional harm that may result from workers being unable to obtain health insurance is a lack of social cohesion; americans working hard and failing to obtain the basic necessities of american life, like health care coverage, will increasingly become disillusioned with the american dream (i.e. meritoc­ racy). the racial inequities in health care resources also contribute to a lack of social cohesion with hispanic citizens being three times more likely to be uninsured compared with white citi­ zens and black citizens who are twice as likely to be uninsured. see emus l. peterson, cong. research serv., health insurance coverage: characteristics of the insured and uninsured populations in 2001, at cr.s-3 (2003). 5 inst. of med., healm insurance out of reach, supra note 4, at 1 (stating lower wage firms, small businesses, and seasonal employers may be ill-equipped or unable to afford the administrative costs associated with employee health plans). 6 id 7 peterson, supra note 4, at 1. 2007) no-fault medical malpractice & single-payer health insurance 35 translates to a high population of those who "are sicker and die sooner. "8 over eighteen thousand unnecessary deaths occur each year due to the lack ofhealth coverage. 9 individuals without health insurance often defer necessary preventa­ tive care and primary health care treatment until it is too late.10 this forces un­ insured individuals into the 'emergency room with less treatable forms of cancer, uncontrolled asthma, diabetes, mental illness, and heart disease.11 forty-three percent of uninsured individuals defer necessary medical treatment when they have a medical problem, compared to ten percent of insured indi­ viduals.12 likely due to this (and other socioeconomic factors) the uninsured consistently exhibit worse clinical health outcomes compared to the insured when it comes to diabetes, heart and kidney disease, infectious disease, and mental illness. 13 lacking health insurance jeopardizes not only the individual but also their extended family and community. in addition to increased disease exposure op­ portunities from untreated illness, out-of-pocket costs can devastate the finan­ cial security of the individual and their entire family.14 the medical billing and collection process, in addition to living with a family member with an untreated or poorly treated illness, emotionally strains families as well. while the extended family bears increased health and fmancial risks, the public health of the community also suffers. emergency rooms are often over­ burdened with people seeking acute primary care services in the emergent care setting. many of these patients suffer from end stage manifestations of other­ wise treatable chronic medical, infectious, or mental disease.15 local public health agencies may also have to divert local funds from emergency prepared­ ness and the control of communicable disease to address the problems of the uninsured. the risk posed by individuals lacking health insurance also impacts the economic security of the whole nation. while uninsured persons pay approxi­ mately thirty-five percent of their medical expenses through out-of-pocket pay­ ments, the government must account for the remainder of the cost.16 workers' 8 inst.ofmed., unlnsurancefacts&figures:'iimuninsuredaresickeranddie sooner 1 (2004), available at http://www.iom.edu/object.fileimaster/171748/0.pdf. 9 id. 10 id 11 see id. 12 ld. 13 id. 14 inst. of med., un1nsurance facts & figures: health insurance: now you've got it, now you don't 2 (2004), available at http://www.iom.edu/object.file/master /17/742/0.pdf[hereinafterinst.ofmiid.,nowyou'vegotit,nowyoudon't]. 15 see inst. of med., un1nsurance facts & figures: un1nsurance costs the country more than you think 1-2 (2004), available aj http://www.iom.edu/object.file/master/17/746/0.pdf (discussing particular vulnerability to outbreaks of measles and influenza). 16 id. at 1. 36 indiana health law review [vol. 4:29 compensation benefits and public charity makes up some of this deficit, but tax dollars and public funds are still used to reimburse hospitals and other health care providers for uncompensated health care expenses related to the uninsured to the tune of over thirty-five billion dollars a year.17 the lack of health care insurance also impacts the united states labor economy. while eighteen-thousand individuals are estimated to die unneces­ sarily every year due to the lack ofhealth insurance,18 millions more suffer from chronic disease or lack the necessary primary care and preventative health ser­ vices that would keep them in the american workplace as productive workers and taxpayers for a longer duration.19 b. the failure of the american medical malpractice liability system even when americans are able to access the health care system, the best medical outcomes do not always result. mistakes happen, and when they do, patients may be handed the card of one of america's most famous health care advocates, the medical malpractice attorney. in most cases, injured patients do not file claims, but in a fraction of cases, they sue; and in a fraction of those cases, they win.20 plaintiff's attorneys declare victory, while physician's scowl, and insurance companies raise liability insurance premiums. 21 patients who sue are then left either with the jackpot ... or without a pot (as the saying goes). the debate over reform of the medical malpractice system in the united states rages on, as it has repeatedly over the last forty years.22 while the true nature of the medical malpractice crisis is in question, 23 it is clear that providers 17 ld. 18 inst. of med., untnsurancb facts & figures: it is now tlmb to extend covbragbtoall 1 (2004),availableathttp://www.iom.edu/0bject.fi1e/master/17/736/0.pdf. see also inst. ofmed., nowyou'vegotit,nowyoudon't,supranote 14, at 1. 19 "the [i om] analysis suggests that, over one year, the diminished health and shorter life spans of americans under age 65 who lack health insurance translates into between $65 billion and $130 billion. these are likely underestimates, given that they don't take into account additional positive effects on health and longevity after age 65 if individuals had always had coverage." inst. of mbd., now you've got it, now you don't, supra note 14, at 2. 20 see infra text accompanying notes 24-26. 21 see infra text accompanying note 42 (testimony oflawrence smarr). 22 some have argued that the current ftustration over the u.s. medical malpractice sys­ tem is a repetition of a similar cycle of ftustrations that took place in the early 1970s and the mid-1980s. brian p. rosman, council on heal1h care econ. & pol'y, medical malpractice in crisis: hbal1h care poucy 0yitons 1 (2003), available at http://sihp.brandeis.edu/council/pubs/malpractice/councilmalpracticebackgroundpaper.pdf. 23 there is considerable debate over the nature of the medical malpractice crisis and whether or not medical malpractice jury awards have increased the costs of managing large mal­ practice insurance claims for insurance companies. see, e.g., bernard black et al., false diag­ nosis, n.y. dmes, mar. 10, 2005, at a27; geoff boehm, debunking medical malpractice myths: unraveling the false premises behind "tort reform," 5 yale j. hbal1h pol'y l. & emics 357, 358-366 (2005). cf am. med. ass'n, medical liability reform-now! 3 2007] no-fault medical malpractice & single-payer health insurance 37 are frustrated and that patients remain in the middle of a battlefield between trial lawyers and insurance companies, providers, and politicians. while the twin goals of the medical malpractice system, 1) compensation to redress banns and 2) deterrence of negligent conduct, fail to be fully realized, the current medical malpractice system remains stagnant in terms of improving health care delivery in the united states. if the primary goal of the american medical malpractice liability system is to make injured patients whole by compensating them for the injuries they sus­ tain, the system is clearly failing. a recent harvard study showed that very few patients injured by the negligent actions of health care providers actually filed suit against those providers (one in eight or 12.5%).24 further, only a fraction of these claimants actually recover any form of economic compensation for their injuries (one in sixteen, or 6.25%).25 thus, many patients sustaining medical injury face the legacy of such injuries without any form of redress or compensation. additionally, those claimants who secure judgments at the trial level typi­ cally have to wait years after their initial filing to secure an award.26 economic necessities drive many negligently injured patients into early settlement, a situa­ tion that may not be discouraged by the lawyers representing them on a contin­ gency fee basis.27 such arrangements typically skim an immediate thirty to forty percent of the award for attorney's fees and court costs, and after settling all past and present medical bills and personal debt due to lost wages, may leave little in the form of actual (allegedly-to-make-whole) compensation. the undeniable wish for most injured patient-plaintiffs (and their attor­ neys) who stick it out through the entire litigation process is that they will be the ones to cash in on millions of dollars in punitive and other non-economic damages. yet, even for these victorious plaintiffs, a monetary award is unlikely to address the full extent of emotional hardships that result from dealing with the prolonged litigation process, a lifetime of medical injury, the unfulfilled (2006), available at http://www.ama-assn.orglamallpubluploadlmml-1/m1mow.pdf[hereinafter am. med. ass'n, medical liability reform). 24 jeffery o'connell & james f. neale. hmo's, cost containment, and early offers: new malpractice threats and proposed reforms, 14 j. conlllmp. heal:ml. &pol'y 287,294, 294 n.52 (1998) (citing to a harvard 1990 medical malpractice report to the state ofnew york). 25 id. 26 one study showed, in the year of2000, that the average time for resolution of a medi­ cal malpractice litigation claim was forty-five months or over three-and-a-half years. randall r. bovbjerg & brian raymond, kaiser permanente inst. for heal1h pol'y, patient safety, just compensation and medical liability reform 8 (2003), available at http://www.kpihp.org/publicationsldocslpatient_safety.pdf. 27 motivations may exist for the plaintiff's lawyer to encourage early settlement rather than pursuing a trial, regardless of the patient's best interests. if the lawyer stands to make a quick and efficient contingency fee. alternatively, iqjured patients facing growing medical bills, lost wages, and uncertain chances in the courtroom may accept a lower settlement than they may be entitled, depending on the extent of their injwies. 38 indiana realm law review [vol. 4:29 desire for apology, and arguably, the hope for institutional change. 28 if the secondary goal of the american medical malpractice liability system is to deter physicians from negligent conduct, the system falls short here as well. instead of fostering the conversations necessary to elicit institutional change, the conversations of the medical establishment focus on the allegedly greedy lawyers and their allegedly frivolous, money-seeking claims filed on behalf of their clients. physicians characterize the tort system as a corrupt one that allocates resources unfairly to lottery winners and cruelly punishes "compe­ tent, hardworking practitioners.'.29 studies showing that successful claims de­ pend more on the extent of injury rather than the actual negligence of the provider0 only enforce such provider claims and stimulate concern with over­ deterrence and the practice of defensive medicine. 31 providers remain left with the notion that the only institution that needs change is one oflegal rather than medical origin. characterizing the legal system as the problem prevents the necessary fo­ cus on the medical institutions that allow serious and medically negligent inju­ ries to occur. and clearly, negligent and preventable death does occur; the institute ofmedicine ("iom") has reported that up to 98,000 deaths a year oc­ cur from medical error.32 the national costs associated with such medical er­ rors are estimated to be in the billions.33 despite this stunning volume of unnecessary patient death and injury, the medical establishment seems more vocal about the necessity of medical malpractice liability reform than the issue of patient safety.34 addressing the institutional deficiencies that lead to preventable medical injury requires open conversation and analysis of the patient-provider interac28 in addition, the desire to become the jackpot verdict winner drives an increased and unnecessary padding of medical treatment and lost employment opportunity, and allegations of fraudulent and unnecessary claims. see, e.g., jeffiey o'connell, a proposed remedy for mis­ sissippi's malpractice mrseries, 22 miss. c. l. rev. 1, 3 (2002). 29 david· m. studdert et al., medical malpractice, 350 new eng. j. med. 283, 283 (2004). 30 o'connell & neale, supra note 24, at 295 (citing troyen a. brennan et al., relation between negligent adverse events and the outcomes of medical malpractice litigation, 335 neweng.j.me0.1963, 1966(1996)). 31 defensive medicine may consist of either ordering additional unnecessary tests unjus­ tified by medical indications (''positive defensiveness") or denying treatment to persons who present complicated medical issues and are deemed high risk ("negative defensiveness"). bovbjerg & raymond, supra note 26, at 11. 32 inst.ofmed., toerrishuman:bundingasaferheal111caresystem 1 (linda t. kohn et al. eds., 2000) (discussing commonly cited medical errors including surgical mis­ takes and medication errors) (hereinafter inst. of meo., to err is human]. this represents more deaths per year than are attributable to motor vehicle accidents (43,458), breast cancer (42,297), or aids (16,516). /d. 33 /d. at 1-2 (estimating the associated cost attributed to such error as between seventeen to twenty-nine billion dollars). 34 boehm, supra note 23, at 357. 2007) no-fault medical malpractice & single-payer health insurance 39 tions that lead to such medical errors.35 however, the current system of mal­ practice liability offers little encouragement for such open analysis and creates incentives for provider silence in the face of patient injury and provider negli­ gence. 36 while ethical obligations and even regulatory duties37 call for the dis­ closure of medical negligence that results in patient injury, physicians are still likely to fear such disclosure as a pathway to a lurking malpractice suit. apolo­ gies remain unlikely in this setting, especially as the finger-pointing process of medical malpractice litigation begins. 38 discussion of medical error that does not result in tangible patient injury may even be stifled, as this evidence could be used in future malpractice litigation against providers. physicians may also be fearful of open discussion with their peers who may be called to testify against them as expert witnesses at trial. 39 in the environment of fear and silence that is stimulated by health care providers seeking to avoid personal liability in malpractice suits, deterrence of medical error takes a back seat to deterrence oflitigation.40 the tension that exists between the deterrence of medical error and the current system of medi­ cal malpractice liability signals the weakness of the current framework for our health care system. greater efforts are needed to ensure deterrence of errors, and less time and energy needs to be spent on avoiding litigation. the ultimate goal of the medical malpractice system should be to improve overall health care delivery. again, however, realization of this overarching goal falls short. while stimulating the practice of defensive medicine and pro­ viders' fear of litigation, and failing to provide adequate re9fess for patients sustaining preventable medical injuries, the current system of medical malprac­ tice litigation may also be limiting the scope of both health care delivery and 35 inst. of med., to err is human, supra note 32, passim. 36 /d. at3. 37 in response to the ''to err is human" report, supra note 32, the joint commission implemented new regulations requiring reporting of medical negligence and unanticipated out­ comes. e.g., lee taft, apology and medical mistake: opportunity or foil?, 14 annals healrn l. 55, 56 (2005) (citing jcaho hospital accreditation standard ri.2.90. 2004). 38 note that physicians may be explicitly counseled against admissions of mistake, ac­ knowledgement of error, or the granting of any apology that could be construed as an admission ofliability for medical injury. taft, supra note 37, at 58 (describing how physicians seeking to express an apology to patients who suffer injury due to medical error are confronted with a moral dilemma when they are counseled not to make such statements). 39 note that providers may also feel professional pressure from their peers to maintain an unhealthy perfectionism that does not facilitate the admission of mistake. it may be argued that slogans such as "best of the best" and others exemplify this seemingly unhealthy attitude among physicians. see, e.g., thank you to the johns hopkins family for once again making us # 1, http://www.hopkinsmedicine.orglusnewslbest_poster.pd:f. 40 e.g., boehm, supra note 23, at 357. the american medical association, for example, tends to focus its malpractice lobbying energies on limiting liability for physicians rather than seeking ways to reduce medical errors. see id. see also am. med. ass'n, medical liability reform, supra note 23 (highlighting the focus on tort reform by physicians). 40 indiana health law review [vol. 4:29 citizens' access to care.41 the medical liability insurance industry argues that as malpractice claims increase and as jury awards and settlement figures continue to rise, they will be forced to continue raising malpractice insurance premiums or leave the market altogether. 42 in response to increasing insurance premiums, many providers have limited the scope of their practices by eliminating high risk procedures (such as obstetric services), moving to less litigious areas of the country, or abandoning the practice of medicine altogether.43 hospitals have also re­ sponded by limiting the number of high risk providers or reducing health cov­ erage volume in high risk settings (such as emergency rooms).44 thus, any increase in malpractice premiums tends to reduce the variety of care options, limit the volume of available care, and raise overall health care costs.45 ill. the optimal american health care system: overlapping health interests between patients and providers in understanding the current failures of the american health care delivery and malpractice liability systems, it is important to ascertain the interests of the significant players in these systems. while the political rhetoric pits health care consumers and their interests against those of physicians and other providers, patients and providers actually have an overlapping vision of the optimal state of health care delivery. it is undeniable that every citizen wants access to high quality health care when faced with medical disease or injury. equally clear is the notion that in­ dividuals suffering from such maladies do not want to face bankruptcy or ex­ treme financial hardship to secure access to adequate medical care. while demanding affordable treatment costs, american consumers also demand the efficient use of tax dollars in health care.· health care consumers also typically 41 0fficeof1heassistanf8ec'vforplann:ing&evaluanon, u.s.dep't ofheal1h & human servs., addressing 1he new heal1h care crisis: reforming 1he medical lmgation system to improve 1he quauiy of heal1h care 3-10 (2003), available at http://aspe.hhs.gov/daltcp/reports/medliab.pdf(hereinafter addressing1henewheal1hcare crisis]. 42 see patient access crisis: the role of medical litigation: hearing before the s. ju­ diciary comm., 1 08th cong. (2003) (statement oflawrence smarr, president, physician insur­ ers association of america) (describing the losses of the medical liability insurance industry between 1999 and 2001 and stating that in order to operate on a break-even basis insurance rate increases for providers are to be expected); see also addressing me new healmcare crisis, supra note 41. 43 addressing 1he new healm care crisis, supra note 41, at 3-6. 44 threats of potential liability and rising malpractice premiums even affect medical students' career paths; students may avoid high risk specialties or avoid residencies in areas of the country perceived as litigious. am. men. ass'n, medical liablljty reform, supra note 23, at4. 45 addressing 1he new healm care crisis, supra note 41, at 3-11. 2007] no-fault medical malpractice & single-payer health insurance 41 demand increased access to services, simplified billing processes, and the re­ tained ability to choose their own. physicians. in sum, citizens want to maintain the best possible standard of care, including access to the best providers and the most innovative technology, all at an affordable cost.46 when patients suffer medical injury, these goals do not radically change.47 yet injured patients and their families are often driven toward litigation in or­ der to obtain the resources necessary to deal with their injuries and get on with their lives.48 in addition, they desire accountability for their injuries.49 individ­ ual and institutional apology, institutional change, or at times, individual civil and criminal accountability are all possible ways a plaintiff might seek redress and accountability for his or her injury. such plaintiffs, however, rarely want to go to the courtroom at any point in this process. 50 physicians and other health care providers share these desires. they too seek the best possible standard of care51 and access to the most innovative medical technology. similar to patients being free to choose their physicians and treatment plans, so too do physicians desire the ability to freely practice medicine within the highest possible standards. additionally, providers desire economic reliability: not the inconsistency that results from rapidly changing malpractice premiums, health care reimbursement rates, and other financial burdens that interfere with the practice of medicine. 52 while some seek to maintain the ability of physicians to act as regular businessmen and women of­ fering an important and unique commodity, 53 many seek to maintain the high academic standard that surrounds them during medical training, working as a 46 see, e.g., henry j. kaiser family found., health care priorities-most important healthcareproblem-healthpollr.ep0rt-february2004 (2004), available at http://kaisernetwork.org (search "health poll search" for "search by topics," with topic, "health care priorities," subtopic, "most important health care problem," view date ''feb 05, 2004."). 47 patients suffering from medically related injuries still want the best possible standard ofliving, access to the best providers, and the most innovative technology. 48 e.g., bovbjerg & raymond, supra note 26, at 13. 49 !d. at 12. 50 see, e.g., america'shealthinsurancepl.ans,patients' rigiits---postelection health care priorlties survey-november 2004, available at http://kaisernetwork.org (search "health poll search" for "search by topics." with topic, "patient's rights," subtopic, "patient's rights," view date "nov 03, 2004'') (providing poll data showing reluctance of pa­ tients to sue providers in cases of conflict; seventy-one percent favored administrative resolution as compared to eighteen percent preferring litigation process). 51 physicians, too, seek the best possible standard of living. 52 cf the henry j. kaiserfamilyfound.,nationalsurveyofphysicianspartiii: doctors' opinions about their profession 4 (2002), available at http://www.ldf.org lkaiserpolls/loader.cfi:n?url=/commonspot/security/getfile.cfin&pageid= 13966 (discussing pro­ vider dissatisfaction with increased paperwork and administrative responsibilities unrelated to patient care and frustration over inconsistent projected income levels). 53 see, e.g., merrill matthews. medicine as a business, 71 the mount sinai j. of meo. 225, 226 (2004) (arguing that the medical profession and american health system would best be served under a pure business model). 42 indiana health law review [vol. 4:29 health care team to improve and maintain a high quality of health for their pa­ tients. 54 and while physicians and other providers may be reluctant to admit that they make mistakes, they will admit them, with the wish that they are judged as humans rather than ''malevolent tortfeasors:" humans entitled to make mistakes and not pay unjustly for them. 55 like consumers, physicians maintain a strong desire to avoid the courtroom, and at the same time seek to maintain high professional standards. they also strive for individual and insti­ tutional accountability and improvement and are generally willing to provide adequate redress for patients who are genuinely injured by medical error. 56 despite the apparent overlap of patient and provider interests, however, mainstream policy proposals fail to link or establish the mutual coexistence of their desires. rather, two distinct spheres of health care reform have devel­ oped: (1) a movement for tort reform undertaken largely by provider and insur­ ance interests and (2) a grassroots movement for universal health coverage. part n will discuss these two distinct spheres of health care reform activity and will lay groundwork for the idea that dual and simultaneous reform is required for the success of either reform movement part v will follow with a discussion of the advantages of such a dual policy approach. n. discussing the alternatives: universal health care and medical malpractice liabiuty reform in the american heal til care system a. tort reform: from alternative dispute resolution57 to arm-wrestling? despite the apparent overlap in the interests of patients and providers, re­ form proposals for the american health care system fail to adequately take both parties' wishes into consideration. instead most reform efforts focus on either the medical malpractice liability system or expanding coverage for those with­ out health insurance. in either case, the dynamic political rhetoric is one of fin­ ger-pointing, either toward allegedly greedy trial lawyers and runaway juries driving up health care costs, insurance companies allegedly concerned more 54 see, e.g., herbert m. swick, academic medicine must deal with the clash of business and professional values, 73 acad. med. 751, 755 (1998) (''the leaders of academic medicine must preserve the primacy of the academic enterprise and professional values even as we con­ front a 'profit-driven, geographically dispersed corporate system with capitalistic values."'). ss taft, supra note 37, at 58 (discussing the "intolerable dilemma" that physicians face in wanting to offer patients acknowledgment and apologies for medical errors and a health care system that does not allow such acknowledgment) 56 !d.; albert w. wu, medical error: the second victim, 320 brit. med. j. 726, 726 (2000). 57 alternative dispute resolution ("adr") models include dispute settlement through structured negotiation, arbitration, mediation, and summary jury trial, amongst others. for a background primer on alternative dispute resolution, see generally leonard l riskin & james e. westbrook, dispute resolution and lawyers (2d ed. 1997). 2007] no-fault medical malpractice & single-payer health insurance 43 with fiscal health than health care, or toward physicians and medical institu­ tions allegedly trampling patient rights and failing miserably to provide an af­ fordable and comprehensive system of health care for all. as previously discussed, most medical liability reform seeks to deter liti­ gation rather than improve compensation for injured patients or improve the quality of care. 58 major proposals for medical malpractice liability reform in­ clude 1) placing caps on non-economic damages that successful patient­ plaintiffs may be awarded, 2) limiting the statute of limitations and lawyer's fees for the filing of malpractice suits, and 3) creating mechanisms for judicial review and the post-verdict reduction of jury awards. 59 several of these meas­ ures have been implemented in various states. 60 other reform proposals seek to remove malpractice disputes from the trial setting altogether, utilizing alterna­ tive forms of dispute resolution, such as 4) arbitration or mediation61 and 5) medical review courts. 62 an additional reform proposal is 6) exclusive enterprise liability, whereby hospitals and other medical institutions undertake the full extent ofliability for the providers practicing within their walls. 63 while lessening liability insurance pressures on individual providers, deep-pocketed medical institutions, such as hospitals, would still be subject to large awards. thus, the risk pool created at the hospital, rather than individual physician, level, still remains in jeopardy.64 institutional "conspiracies of silence'.6s may also be produced under such a scheme.66 another option is 7) early-offer tort reform. 67 under this system, civil dess see supra text and references accompanying notes 29-40 (discussing factors that lead to attempts at deterring litigation rather than medical error). 59 e.g., bovbjerg& raymond, supra note 26, at 25. judges may be granted the ability to reduce the jury's award with the collateral offset rule, whereby the award is decreased by the amount compensated through other means (such as existing disability and health insurance plans purchased by plaintifts prior to sustaining their injury). see id this and other measures are typically based on the design of california's medical injury compensation reform act of1975 ("micra''). see rosman, supra note 22, at 3-4. 60 bovbjerg & raymond, supra note 26, at 25 ("'ne tabulation lists fourteen states that have enacted caps on the recovery of non-economic damages in medical malpractice actions ... :'). 61 the use of summary jury trials presents another possibility. these abbreviated trials are designed by the parties to test specific issues by an agreed upon mock jury. id at 16. 62 medical review courts are set up to exclusively hear claims of medical malpractice. id. at 18. medically technical expertise in the judiciary could thus be concentrated at/either the state or national level. /d. medical review panels have also been set up in a limited number of states to screen claims before they reach the courtroom. see also studdert et at., supra note 29, at 287 (discussing reform efforts that limit access to the courts). 63 bovbjerg & raymond, supra note 26, at 16. 64 ld. 6s id. 66 ld. 67 id 44 indiana heal1h law review [vol. 4:29 fendants have the opportunity to compensate injured plaintiffs within a pre­ scribed number of days after an injury is sustained for the value of their medical expenses, lost wages, and reasonable attorney's fees.68 while plaintiffs would be able to recover the full amount of claimed economic losses in a relatively short amount of time, they would be required to surrender any tort remedy and access to punitive damage awards.69 claimants who reject such an award would then face increased evidentiary burdens at the trial level (a clear and convincing standard instead of a preponderance of the evidence standard) for more egregious conduct (willful or wanton misconduct rather than mere negli­ gence).70 if defendants fail to make an early offer, standard medical malprac­ tice litigation could ensue with the evidentiary burdens and award limits unchanged. 71 early-option schemes would likely speed up the compensation process for injured patients and place a cap on contingency fee arrangements. 72 ideally, only the most egregious claims would be brought to trial, 73 while a greater number of injured patients would tum to the early-offer system to obtain redress for the injuries they have sustained. critics of early-offer tort refonn character­ ize providers as reluctant to admit liability at any point, for fear of stigmatiza­ tion and an increased potential for liability at the trial level in subsequent cases. 74 critics also charge that settlement is already an option for patients and providers. 75 yet another alternative for tort reform concerns is 8) no-fault compensa­ tion schemes. while a radical departure from traditional malpractice tort law, no-fault compensation schemes likely provide the most effective and compre­ hensive compensatory mechanism for injured patients. 76 under such a system, providers are held strictly liable for damages caused by preventable medical injury, eliminating any burden of proof on plaintiffs to establish provider negli­ gence in court. 77 injured patients would be compensated according to a prede­ termined schedule of payments based on type and extent of injury. 78 the workers' compensation system in the united states presents a model 68 see, e.g., o'connell & neale, supra note 24, at 310. 69 id. 70 id at 311. 71 /d. 12 /d. 73 cf. bovbjero & raymond, supra note 26, at 17 (stating that a potential weakness of the early-offer system is that providers might" 'game' the system by making offers only to badly injured people"). 14 /d. 15 see id 76 david studdert & troyen brennan, no fault compensation for medical injuries: the prospect for error prevention, 286 j. am. med. ass'n 217-223 (2001 ). n bovbjerg & raymond, supra note 26, at 20. 18 id 2007) no-fault medical malpractice & single-payer heal til insurance 45 for this type ofliability reform. 79 employees injured in the workplace are typi­ cally entitled up to two-thirds of their present wages for a set number of years. 80 medical costs for injured workers are covered indefinitely and more recently are covered on a periodic payment basis. 81 applying this model to the medical malpractice setting, in exchange for quick claim determination and broad access to compensation, patients could easily recover lost wages and costs associated with medical expenses, all in the absence of legal counsel and outside of the courtroom. as discussed above, the current system of medical malpractice liability fails in both adequately compensating injured patients and effectively deterring negligent providers. in separating the goals of patient compensation from pro­ vider deterrence, a no-fault compensation system would serve to effectively compensate the majority of patients sustaining injuries due to medical error,82 while at the same time creating (and allowing) the incentives for providers and institutions to work in a cooperative and open manner to reduce preventable medical injury. as negligence would not be an issue at the trial setting, there would be no need to maintain institutional or individual silence. 83 thus, the necessary internal, academic, and quality assurance collaborations could take place in order to address the practices that lead to medical error and injury. again, with less fear of stigmatization, physicians and health care institutions could involve a greater number of parties in a transparent patient-injury review process in order to more effectively address patient safety concerns. 84 while consistently striving to improve patient safety in this manner, the discussion of medical error could be normalized in an accountable medical institution. the administrative efficiency of such a system could save untold sums in terms of avoiding the traditional adversarial malpractice litigation process.85 the exorbitant costs of expert witness testimony and the lengthy trial process could be eliminated, and costs associated with delayed compensation and con­ tingency fee arrangements could be substantially reduced. the emotional pain and suffering associated with the trial experience would be eliminated. 79 !d. 80 !d. 81 id 82 while recovery for each individual injury could arguably be less than what successful litigants are awarded at trial under a workers' compensation-type system, a far greater number of injured patients would actually receive compensation as compared to the litigation route. 83 see supra notes 29-40 and accompanying text (discussing institutional silence surrounding treatment related injuries). 84 see inst. of med., to err is human, supra note 32, at l 0. 85 reductions in claim resolution time and judicial overhead costs have been cited in the no-fault systems in place in virginia and florida. bovbjerg & raymond, supra note 26, at 1920. 46 indiana health law review [vol. 4:29 medical models for such a system already exist in virginia and florida, 86 two states that have enacted administrative compensation schemes for severely injured newborns. in an attempt to reduce malpractice liability and insurance premiums for practicing obstetricians, virginia established a no-fault system in 1987 and florida one in 1988.87 recent studies have shown that these models provide rapid compensation with reduced administrative cost when compared to the litigation process. 88 further, reduced malpractice premiums for providers in the area can be attributed to such systems. 89 the biggest challenge for the no-fault system would be making determina­ tions of medical error versus disease progression or negative outcome.90 no­ fault systems would not provide compensation for all adverse outcomes in the medical setting, only those attributable to preventable medical error.91 coun­ tries utilizing no-fault systems have addressed this issue by using sophisticated medical panels to weigh in on issues of medical preventability. 92 in addition, while any notion that a no-fault compensation system unfairly limits the ability of recklessly injured patients to recover damages, access to the traditional civil tort system93 for suits alleging willful and wanton behavior on behalf of medical providers could be maintained. b. universally undercovered: the push for universal health care in america while the dispute over medical malpractice liability reform rages on, the battle for universal access to health care is waged on a different front. the presidential administrations of truman, nixon, and clinton each attempted to create a national health care safety net for all americans but each failed. 94 while most americans support a right of health care for all citizens95 and many 86 !d. at i 9. at the federal level. a no-fault compensation scheme exists under the na­ tional childhood vaccine injury act. e.g., josephine y. king, no fault compensation for medicallnjuries, 8 j. contemp. iiealtii l. & pol'y 227, 233-34 ( 1992). 87 id. see, e.g., king, supra note 86, at 234, 234 n.34. 88 id. at 234. 89 id. 90 cf bovbjerg & raymond, supra note 26, at 20 (discussing the alternatives for the administrative determination of preventable injury from natural disease progression). 91 see id. 92 !d. 93 willful and wanton negligence could also be deterred and addressed by the criminal justice system when necessary. 94 e.g., randall r. bovbjerg & frank c. ullman, health insurance and health access: reengineering local safety nets, 22 j. legalmed. 247,251 (2001). 95 polls show that sixty to seventy percent of americans would support a publicly fi­ nanced universal health care system. see, e.g., washington post-abc news poll: health care, w ashlngtonpost .com, oct. 20, 2003, at no. 4 7, available at http://www. washingtonpost .com/wp-srv/politics/polls/vault/storiesldata1 02003.html [hereinafter washington post-abc news pollj (showing that sixty-two percent of americans would prefer universal health care 2007]no-faultmedicalmalpractice&single-payerhealthlnsurance 47 physicians and public health administrators feel that a universal system of health care is long overdue in the united states,96 progress stalls over how to best implement a universal health care plan. the issue ofhealth care financing stands as a significant hurdle in the ful­ fillment of establishing universal health care in america.97 as one of the rich­ est countries in the world, the united states clearly has the financial capability to implement a quality system of universal health care for its citizens.98 the fact that the most innovative medical research, technological development, and highest levels of professional training take place within the united states high­ lights this capability further. yet the burden of cost remains one of the most formidable hurdles for uni­ versal health care reform. the united states already spends one-sixth of its budget on health related expenses, with a projection of growth of health costs in sight. the fact that we already spend twice as much as other industrialized na­ tions with universal health care and fail to achieve similar patient outcomes is disheartening. thus with huge health expenditures already being made in a flawed system, americans are reluctant to support new taxes to fund universal health care. in addition to the issue of cost, proponents of universal health care dis­ agree about whether to increase health care coverage utilizing a pragmatic ap­ proach or one of radical and revolutionary change. 99 pragmatism in health politics and administration is the status quo and has been effective in obtaining important health benefits for select segments of the population.100 advocates of pragmatic health reform cite these measures along with the existing public con­ fidence in the medicare and medicaid systems.101 in addition, pragmatists arbased on a five-day poll taken in october 2003). see also john r. battista & justine mccabe, the case for single payer, universal health care for the united states, address before the ass'n of state green parties, moodus, connecticut (june 4, 1999), outline available at http://cthealth.serverlol.com/the_case_for_universal_health_care_in_the_united_states.htm. 96 see, e.g., mohammad akhter,apha policies on universal health care: health for a few or health for all?, 93 am. j. pub. iif.alti:i 99, 100 (2003) (discussing public health profes­ sional and political support for achieving universal health care access and also highlighting the fact that many other countries provide universal health care services "at a cost to the sponsoring governments and the public that is modest compared with the annual expenditures for health care in the united states."). 97 id 98 canada and many european nations provide universal health coverage for far less cost than the united states spends on health care. see supra note 3 and accompanying text (demon­ strating that other countries provide universal health care access to their citizens for less than the united states currently spends on health care and have better public health outcomes). 99 akhter, supra note 96, at 99. 100 for instance children under the state children's health insurance program ("schip"), the elderly, the impoverished, and dialysis patients suffering from end-stage renal disease, amongst others. 101 see, e.g., john tooker, affordable health insurance for all is possible by means of a pragmatic approach, 93 am. j. pub. iif.alti:i 106, 106 (2003) (arguing for the pragmatic expan­ sion of the current health system toward universal coverage). 48 indiana health law review [vol. 4:29 gue that any attempt to radically upset the status quo will meet overwhelming resistance from health care players still making a great deal of profit in the cur­ rent system, such as insurance companies and large provider networks. 102 pragmatic health reform policies include: 1) implementing premium subsidies and tax credits to increase access to health care, 2) fostering greater competitive pressure between existing health plans, 3) enacting greater regulation of insur­ ance rates in the small-group market, 4) mandating employer-based health cov­ erage, and 5) establishing purchasing groups for individuals seeking health insurance outside of their employment context 103 most of these plans represent incremental tweaks of the system that may produce a small impact on the num­ ber of individuals without health insurance, but they still allow many citizens to purchase inadequate levels of care or to be priced out of health coverage en­ tirely.104 c. the physicians' working group proposal for single-payer national health insurance: "[the] [p]ursuit of corporate profit and persona/fortune have no place in care-giving. "105 more idealistic health reformers stress the need for immediate change, highlighting the eighteen thousand preventable deaths that occur every year due to a lack of health insurance, 106 the continuously growing number ofunderin­ sured and uninsured citizens burdening our current system of health care, and the public health dangers individuals who fail to obtain medical care present.107 reformers draw attention to the inequities present in a system that delivers the highest quality of care in the world, while at the same time denying citizens access to basic primary care services, prenatal care, and simple immuniza­ tions.108 at the same time, they stress that immediate and universal access to quality health care will not only improve public health and social equity, but 102 akhter, supra note 96. 103 tooker, supra note 101, at 107. see also physicians' working group, supra note 1. 104 physicians' working group, supra note 1. !os id. at 799. 106 see supra note 9. 107 physicians' working group, supra note 1, at 798. 108 akhter points out that nearly two-thirds of the uninsured come from low income fami­ lies and nearly half are represented by racial and ethnic minorities. akhter, supra note 96, at 99. the inequities apparent·in an economic and racial analysis ofhealth care access are painful (thirty-three percent of all hispanics, nineteen percent of all black americans and ten percent of all white americans are uninsured). physicians' working group, supra note 1, at 798. an additional argument that supports a more radical approach in lieu of the pragmatic expansion of health care access is that with the lack of concentrated political power among socially and eco­ nomically marginalized groups, incremental reforms are unlikely to ever reach these socially disadvantaged citizens. see also robert putsch & linda pololi, distributive justice in ameri­ can healthcare: institutions, power and the equitable care of patients, 10 am. j. managed care sp45 (2004). 2007] no-fault medical malpractice & single-payer heal1h insurance 49 also that it will improve the financing of health care in america. 109 the most promising proposals to immediately ensure quality health care for all americans are those that establish a national system ofhealth care under a single-payer national health insurance program. the comprehensive physi­ cians' working group for single-payer national health insurance proposal for such a system includes the following: 1) preventative, primary, and specialty care, 2) long-term nursing, rehabilitative, and at home care, 3) mental health and dental care, and 4) coverage of pharmaceuticals and medical supplies.110 by eliminating the myriad of private insurance providers, the plan minimizes billing complexities111 and the for-profit administrative expense of marketing, promotion, and health care profiteering. a national single-payer program cuts the administrative waste of private health insurers, for-profit hospitals, and hmos that operate with administrative costs of twelve to twenty-five percent as compared to administrative costs for the public medicare or the canadian na­ tional health insurance programs (which enjoys administrative costs ofless than 3.2% ).112 the plan would also cut administrative overhead for providers, who would not have to spend as much time and energy on billing schemes113 or ob­ taining reimbursement from multiple health care plans. large administrative savings would also be stimulated by the increased bargaining power under a single-payer plan. a national health insurance sys­ tem would be in a strong bargaining position in relation to the hospitals, phar­ maceutical companies, and provider ·organizations with which it would establish negotiated fee schedules.114 with such bargaining power, stronger steps could be taken to remove the private profit motives that lead to billions of dollars being spent on marketing and advertising. additionally, global budget­ ing115 could shift resources to improving patient care by eliminating the admin­ istrative costs of individual billing for these health care entities.116 global administration would improve patient care in other ways as well. patient need, rather than market motivation, would motivate capital invest109 physicians' working group, supra note 1, at 798-99. 110 id 111 efficiency is obtained as single-payer health plans rely on tax collection mechanisms rather than separate billing schemes. p. hussey & g.f. anderson, a comparison ofsingle-and multi-payer health insurance systems and options for reform, 66 health pol'y 215, 216 (2003). 112 physicians' working group, supra note 1, at 799; david u. himmelstein & steffie woolhandler, national health insurance or incremental reform: aim high, or at our feet? 93 am. j. pub. health 102, 103 (2003). 113 a single-payer system funded with general tax revenues eliminates the costs associ­ ated with the administration of alternative collection systems. see hussey & anderson, supra note 111. 114 id. at 219. 115 global budgeting is essentially paying hospitals a monthly lump sum so that billing patients individually is unnecessary. physicians' working group, supra note 1, at 800. 116 see id. 50 indiana healm law review [vol. 4:29 ments. rather than wasting expenditures on advertising executives to maintain superfluous services, increase market shares, or crash commercially-untapped­ though-adequate-health-care-areas, experienced health care administrators could conduct periodic technological and infrastructure reviews and wisely re­ invest in increased access and improved care. this would prevent wasteful du­ plication of health care services, medical technology, and other health resources. planning based on need, rather than profit motivation, would in­ crease health equity and extend adequate health care into isolated social, geo­ graphic, or racially segregated areas that private markets typically do not reach.117 national single-payer health insurance could foster greater health equity in other ways as well. a national single-payer health insurance plan would elimi­ nate the problematic practice of risk avoidance through adverse patient selec­ tion demonstrated by private insurance companies. 118 private health insurers have the incentive to avoid high risk patients or those with preexisting health conditions that have high health care utilization patterns. thus sicker patients find it difficult to obtain adequate and affordable health coverage in the present system, or any health insurance coverage at all. 119 as national health insurance would provide adequate coverage for all citizens, adverse selection would cease. despite the administrative cost savings and health equities a national sin­ gle-payer health insurance plan would provide, policy pragmatists suggest that the public is wary of a large and radically different system of health care fi­ nance.120 single-payer advocates counter this wariness with the evidence that 117 ld at 799. 118 hussey & anderson, supra note 111, at 218. 119 !d.; see also putsch & pololi, supra note 108, at sp4 7. 120 poll data from the last several years shows that fifty-six to sixty-two percent of the public prefers "a national health plan, financed by taxpayers, in which all americans would get their insurance from a single government plan," over the present employment based health in­ surance system. abc news, henry j. kaiser family found. & usa today, universal health insurance-health care pou.-8eptember 2006, available at http://kaisemetwork.org (search "health poll search" under "advanced keyword search" for keyword, ''universal health insurance," view date "sep 07, 2006," then poll question titled "which do you prefer .•. ") (fifty-six percent prefer universal health insurance); abc news & wash. post, universal health insurance-pou.-0crober 2003, available at http://kaisemetwork.org (search "health poll search" under "advanced keyword search" for keyword, ''universal health insurance," view date "oct 09, 2003," then poll question titled "which do you prefer ... ") (sixty-two percent prefer universal health insurance). by compari­ son, interestingly, approximately forty percent of the public currently favors a national health plan when the survey failed to explicitly contrast it with any other health care insurance system, including the current one. henry j. kaiser f amilyfound. & harv. school of pub. health. health care agenda for the new congress survey-november 2004, available at http://kaisemetwork.org (search "health poll search" under" advanced keyword search" for keyword, "national health plan," view date "nov 04, 2004.") (thirty-seven percent favor a national health plan); henry j. kaiser family found., harv. univ. kennedy school of 2007] no-fault medical malpractice & slngle-pa yer health insurance 51 most health care in america is already financed by public funds, representing approximately sixty percent of total health care spending in the united states.122 and in addition to the widespread improvements in health equity and coverage that would benefit the majority of the population, a national single-payer plan provides increased funding for the preventative care benefits necessary to im­ prove the public health. while such initiatives are frequently called for by the general public and in the legislature, they are seldom effectuated as it is hard to bill individual patients for such services in the private health care setting (a sort of medical tragedy of the commons). national coordination ofhealth care and health policy also allows for such innovations as national patient data systems to improve research and recordkeeping, and global patient safety data tracking, thereby eliminating the practical inefficiencies of data transfer upon a patient's change of health plan in the private market. lastly, a national health insurance program could lead to increased no­ tions of social solidarity.123 while fostering a "shared sense of responsibility for providing health care to specific groups such as the elderly, the poor, or people with chronic conditions,"124 a national health insurance program per­ petuates the notion that access to adequate health care is a human right for a society of people that has made a pact to provide, ensure, and protect all of the necessities and benefits of a civil life. evidence of such solidarity is demon­ strated across class lines in america with the public support of the medicare program and in canada with citizens' pride over their nation's universal health care program. v. the combination of a no-fault medical malpractice compensation act with a national single-payer health insurance plan the ongoing debate over the best way to reform the american health care system often pits patients and providers against one another in a politically ad­ versarial framework and leaves them caught in the cross-fire of the debate. while citizens remain skeptical of tort reform as an unnecessary limit on their already tenuous health care rights, providers lack adequate incentives to de­ mand universal health care. the combination of a no-fault medical malpractice gov't & nat'l pub. radio, nationalheal1h plan-heal1h caresurvey-mar.ch2002, available at http://kaisemetwork.org (search "health poll search" under "advanced keyword search" for keyword, "national health plan," view date "mar 28, 2002.'') (forty percent favor a national health plan). 122 physicians' working group, supra note 1, at 802. 123 hussey & anderson, supra note 111, at 222. 124 id.; see also himmelstein & woolhandler, supra note 112 ("(s]olidarity is stronger than charity.") (citing professor vicente navarro, md.). the notion of this idea is that public support of a national program serving all citizens would be far greater than piecemeal incre­ mental programs that support only the most wlnerable patient populations (the "charity" cases). seeid. 52 indiana heal til law review [vol. 4:29 compensation act with a grassroots public health movement for universal health care, however, may provide the necessary inducement for both patients and providers to support both measures. a dual policy approach to american health care reform may spur the necessary mix of social activism, industry ac­ quiescence, and political timing that would lead to the best system of health care in the world. a. the patient's perspective on medical malpractice liability reform citizens and patient advocacy groups are sustaining a remarkable battle against local and national tort reform measures, which are largely based on the support and lobbying of triallawyers.125 citizens are reasonably wary of any action that impinges upon their legal rights, especially at a time when they have suffered a medical injury. thus citizens are likely opponents of the most recent widespread tort reform efforts that create further obstacles for injured patients seeking adequate compensation for their injuries and institutional accountability for the circumstances that lead to their injuries. at the same time, most pa­ tients, like their provider-adversaries, abhor the litigation experience and appre­ ciate a quicker and more efficient means to achieve their desired goals in litigation. 126 b. the provider's perspective on a national single-payer system of health care although generally in favor of universal health care in the united states, providers voice fear over a radical overhaul of the american health care sys­ tem.127 while approving of increased health care access for patients, providers may fear that the burden of cost to increase this access will be placed on them. still stinging from repeated cuts in reimbursement rates and rising malpractice insurance premiums in recent years, providers would not favor large salary cuts. 128 in addition, providers fear the notion that the government, like private health managers in the business world before them, will unduly interfere in the delivery of health care in the practice setting.129 while it is unlikely that the 125 see bovbjerg & raymond, supra note 26, at 3. 126 see america's realm insurance plans, supra note 50. 127 see, e.g., ronald t. ackerman & aaron e. carroll. support for national health in­ surance among u.s. physicians: a national survey, 139 annals of internal med. 795 pas­ sim (2003). 128 see, e.g., marks. gorden &john p. dumoulin, am. c. of physicians-am. soc'y of internal med., reimbursement problems undermine medicare 7 (2002), available at http://www.acponline.orglhpp/med _ reim.pdf( discussing the negative impact decreased medi­ care and medicaid reimbursement rates have had on the uninsured). 129 the loss of professional autonomy is of particular concern to physicians. kaiser f amu.. y found., supra note 52. it is arguable, however, that a great deal of professional auton­ omy was lost with the introduction of managed care systems and that management under a gov2007] no-fault medical malpractice & single-payer health insurance 53 reimbursement process and billing administration would be worse than it is in the private multi-payer system, providers also fear being subjected to possibly more paperwork and administrative oversight.130 lastly, the fear continues that provider liability for medical injury will remain unbridled in the malpractice liability system and that malpractice insurance premiums will continue to rise at alarming rates, placing increased pressures on providers seeking economic se­ curity. such fears of increased litigation are likely to become even more pro­ nounced as access is expanded to patients who are traditionally more sick and likely to suffer worse health outcomes.131 c. the proposal: combining a no-fault medical malpractice compensa­ tion act with a national single-payer health insurance plan to capitalize on the.overlapping interests of patients and providers, it may be useful to combine the best policy proposals in the seemingly diverse areas of tort reform and increased health access in order to realize the full extent of benefits that reforms in either area may provide. combining a no-fault medical malpractice compensation act with a national single-payer health insurance sys­ tem could establish the catalytic incentive for patients and providers to align themselves and provide the necessary push to realize both universal health care and an effective system of medical malpractice liability in the united states. by advocating for a no-fault workers' compensation model of medical malpractice liability reform 132 and utilizing the proposal for single-payer na­ tional health insurance submitted by the physician's working group133 to pro­ mote universal health care, both patients and providers may align themselves in a manner that will see to it that they both enjoy a high quality oflife and access to the most responsive, innovative, and comprehensive system of health care in the world. while both patients and providers could view advocacy for this combined set of comprehensive health care reforms as a necessary trade-off to obtain their respective goals, the alignment of patient and provider interests actually seems to produce a mutually beneficial arrangement for all parties. d. how patients will benefit from the proposal in exchange for having limitations placed on the right to bring a civil neg­ ligence suit against medical providers in a court oflaw, patient-citizens would obtain an excellent, equitable, affordable, and continuous system of universal ernmental system would minimally resemble and ideally improve upon this model. 130 the majority of physicians report that managed care arrangements have adversely increased the amount of paperwork and other administrative activities unrelated to patient care. id 131 see, e.g., jeffiey o'connell, blending reform oftortliability and health insurance: a necessary mix, 19 cornell l. rev. 1303, 1303 (1994). 132 see supra text and references accompanying notes 76-93. 133 see supra text and references accompanying notes 105-23. 54 indiana health law review [vol. 4:29 health care, truly the best that the world would have to offer. at the same time, however, patients would obtain a fair, equitable, and rapid system of recovery in the event that the health care received was less than adequate and led to medical injury. now separated in different systems, the dual goals of malprac­ tice litigation, compensation, and deterrence could be more adequately fulfilled. a far greater number of injured patients would receive compensation for their preventable injuries, and they would do so at a greater speed, in a less adversar­ ial manner, outside of the courtroom. in addition, no-fault liability would allow greater accountability amongst providers and institutions that may now more openly admit fault and address the circumstances in the system or practices that led to medical error. this creates more positive incentives for providers and institutions to prevent medical error and injury. while basking in improved community and individual health and admiring the more equitable and eco­ nomically streamlined nature of american health care delivery, patients will enjoy the improved atmosphere of patient safety and the security of knowing that if they are injured, they will have an improved ability to recover for their injuries. at the same time, they will maintain their important role in holding institutions and providers accountable for subpar medical practice. e. how providers will benefit from the proposal in exchange for participating in and serving as leaders during a radical overhaul of the american health care delivery system, providers would enjoy drastically reduced malpractice liability and a reduction in the malpractice in­ surance premium rates associated with it in addition to the great relief that limited interaction with judges, courts of law, and trial lawyers would bring, providers would be the beneficiaries of a new and less complicated practice of medicine. providers would also be able to return to the collaborative and open academic environment where mistakes are discussed more openly and freely, and innovative mechanisms are set in place to improve the delivery of health care with fewer mistakes. providers would deal with fewer forms, less adminis­ trative complication with reimbursement and billing, and more economic secu­ rity in their medical practices. while salary reductions would be likely for the most successful free market medical specialists, most providers will readily trade a measure of income for a reduction in the level of paperwork and tort liability. 134 with consistent and uniform reimbursement rates and without fear of surprise insurance premium hikes, providers can focus on the practice of medicine without being pressured by the bottom line economically. providers who work hard, culture their expertise, and maintain a reputation for excellent bedside manner would still attract the most patients and make the highest sala134 one massachusetts study supports this notion, though a wider sampling of physicians' views definitely needs to be gauged. danny mccormick et al., single-payer national health insurance: physician's views, 164 arch. of intern. med. 300,301 (2004). 2007] no-fault medical malpractice & single-payer health insurance 55 ries.135 in addition, with a universal single-payer health care system, providers would maintain consistent patient populations and could feel proud to be part of a health care system that does not delist physicians from health plans for pro­ viding too much care or drop sick patients because they need high levels of care.136 lastly, providers can strive to be effective practitioners at the commu­ nity and population level, as well as at the individual level, enjoying the funds and support to provide necessary preventative health services. vi. conclusion: a recommendation of revolutionary implementation: moving forward with a dual policy approach a great deal of common ground and shared interest between patients and providers emerges when considering a shared proposal combining a no-fault medical malpractice compensation act with a national single-payer health insur­ ance system. both patients and providers are dissatisfied with the current ineq­ uity, inefficiency, and inadequacy that characterizes the american health care delivery system. forty-five inillion americans suffer without health insurance in one of the richest countries in the world, while countless medical injuries repeat themselves due to the shroud of silence brought about by unrestrained medical malpractice liability. a broad plan coupling a universal system of na­ tional single-payer health insurance with a no-fault system of medical malprac­ tice compensation may provide the necessary bridge to bring the champions of universal health care and tort reform together in the interests of establishing the best possible system of health care in the world. the most important steps in advocating for this dual reform approach are detailed below. 137 a. mobilizing the patient and provider communities to the same side of the health care reform debate in order to achieve this partnership, patients will need to relinquish their shot at the ticket in the litigation lottery and get behind a grassroots movement to improve the public health. this will secure their personal, economic, and health security and ensure a fair and equitable civil justice system; there is no 135 in addition, the private market could remain for providers perfonning elective or un­ covered medical procedures such as plastic surgery, botox or collagen injections, or corrective eye surgery. 136 "clinical decisions [could then] be driven by science and compassion, not the pa­ tient's insurance status or bureaucratic dictim." physicians' working group, supra note 1, at 802. 137 many of these steps are modeled after the pragmatic policy implementation advice offered by john tooker, supra note 101, the recommendations of the physicians' working graup, supra note 1, at 802, and by the description of grassroots reform movements by beatrix hoffinan, health care reform and social movements in the united states, 93 am. j. pus. health 75, 75 (2003). 56 indiana health law review [vol. 4:29 justice when one injured patient wins millions and countless others are left without health security or redress for their injuries. providers will need to allow greater transparency in the institutional processes that analyze medical errors while taking a greater stand in securing sustainable, universal, and affordable access to high quality medical care. providers must accept their humanity and fallibility and address the mistakes that they will undoubtedly make in practice. both parties must exercise the courage necessary to implement this widespread and revolutionary change. b. establishing the necessary links in the academic, public health, gov­ ernmental, and administrative communities providers and patient advocates must take leadership positions not only in the field of health care, but also in governmental and administrative institutions. using a combination of professional and grassroots power and a bipartisan ap­ proach, patients and providers must sell this revolutionary change as the prag­ matic approach. a policy incorporating a combined no-fault medical malpractice compensation act and a national single-payer health insurance sys­ tem represents a compromise of interests and provides mutual benefits for all participants. such compromise is the hallmark of pragmatism. c. preparing an early counterattack against the insurance lobbyists and the trial lawyers a strong patient-provider alliance can gamer the necessary public support and draw attention away from the powerful insurance and trial lawyer interests. at the same time, attempts to build inroads into these highly organized political groups must be made. they are literally fighting for their lives and well-beings as they know it; it will be important to stress to them the important role they will play after the overhaul of the american health care delivery system. many new governmental agents will be needed to process claims and serve as support personnel in national public health, home health, and preventative medicine efforts.138 for attorneys, new areas oflaw will emerge in a statutory system of medical injury compensation, analogous to practice under the workers' com­ pensation system. thus, attorneys will continue to play a significant role in the functional administration of the program and in advocating for justice for those patients injured due to the willful and wanton and criminal conduct of the few, though significantly wayward, health providers. d. arranging a simple yet appropriate and effective marketing strategy it is important to take note of the importance of marketing. the failure of 138 physicians' working group, supra note 1, at 802. 2007] no-fault medical m.alpracrice & s1ngle-pa yer heal1h insurance 57 the clintons' health plan,139 and a general lack of consumer confidence in many public programs, stems in part from the refusal to stimulate and maintain pa­ tient confidence and system morale. while this policy movement seeks to re­ move the majority of the marketing costs from the private administration of health care (especially in the pharmaceutical industry), the importance of mar­ keting, even for public systems ofhealth, should not be underestimated.140 it is guaranteed that opponents of health reform will spend a great deal on such strategies.141 e. obtaining grassroots support and excellent movement leadership efforts strong leadership, a structured organization, and powerful communication are the hallmarks of social change. although successful social movements al­ ways portray charismatic leaders, effective grassroots participation stimulates institutional "change from below."142 grassroots organization is how progres­ sive policy change happens.143 widespread rallying and organizing will have to take place in the fields of medicine and public health, social academia, and throughout the remnants of the progressive american labor movement. patients and providers must demonstrate the initiative and courage to run for office and advocate for change. politics must not be left only to the mon­ eyed business interests. incorporating a true dedication to distributive justice and striving to incorporate the diversity of economic classes and racial and eth­ nic groups disproportionately affected by the lack of access to health care ser­ vices is vital. not only are these groups most in need of institutional change, but they add power, wisdom, and insight to a diversified movement. 139 the lack of effective response to criticisms of the clintons' plan (for instance compar­ ing health care under their plan to service at the department of motor vehicles) was one factor that played a role in the plan's demise. tooker, supra note 101, at 107. 140 /d. 141 an estimated $300 million dollars was spent on political opposition campaigns against the clinton health plan. kant patel & mark e. rushefsky, healm care pouncs and policy in america 285 (1999). this includes expenditures of fourteen million dollars alone on the health insurance association of america's harry and louise advertisements, which showed actors posing as a white, middle class couple discussing the limits placed on patient choice, medical rationing, and the huge bureaucracy that would develop under the clinton plan. see raymond l. goldstein et al., harry and louise and health care reform: romancing public opinion, 26 j. healmpol. pol'v & l. 1325 passim (200 1 )(discussing the ads and the impor­ tance of public opinion in health care reform). 142 hoffinan, supra note 136. 143 for effective examples of grassroots leadership, advocacy and change, look to the examples ofmothers against drunk driving ("maddj or the american association ofretired persons (" aarp"). hospital-physician joint ventures: a promising partnership? introduction eleanor d. kinney• this year and for the second time, the mcdonald merrill ketcham award and lecture were held in conjunction with a symposium convened by the indi­ ana health law review. this year's topic was "hospital-physician joint v en­ tures: a promising partnership?" professor james f. blumstein, the recipient of the mcdonald merrill ketcham award, opened the symposium with his lec­ ture entitled "of doctors and hospitals: setting the analytical framework."1 the relationship between hospitals and physicians is extraordinarily im­ portant. hospitals need physicians to order the admissions and hospital ser­ vices on which hospitals depend for their economic survival. physicians, particularly those in more intensive specialties, need hospitals as sites to deliver their professional services. neither can survive without the other. as professor blumstein observed at the opening of his article, "the issues surrounding the movement toward integration of physician services and the institutional and economic interests of hospitals raise some of the most critical, delicate, and longstanding health policy and law issues confronting analysts and policymak­ ers."2 in his article, professor blumstein identified several issues implicated in the integration of physicians and hospitals. to what degree do economic con­ siderations factor into medical care decision making? what is the appropriate role of physicians, as expert autonomous professionals, in medical care decision making and what are the appropriate legal, institutional, and regulatory struc­ tures to shape that role? his article goes on to delineate expertly how legal obligations and financial responsibilities have redefined and reshaped hospitals and how hospitals have thus moved away from the professional-scientific para­ digm that informed hospital management in the 1960s and 1970s. professor blumstein extols the need for regulatory flexibility in approaching new eco­ nomic relationships between hospitals and their physicians to respond to new circumstances in the marketplace. following professor blumstein's superb lecture was commentary by some • hall render professor oflaw and co-director, williams. and christine s. hall cen­ ter for law and health, indiana university school of law, indianapolis, indiana. 1 see james f. blumstein, of doctors and hospitals: setting the analytical framework for managing and regulating the relationship, 4 ind. healrn l. rev. 209 (2007}. 2 ld. at 211. 206 indiana health law review [vol. 4:205 of the most knowledgeable health lawyers and professionals in the state and, indeed, the nation. greg pemberton, the partner in charge of the health law practice at the law firm oflce miller and past chair of the aba's health law section, expertly moderated the panel. the discussion focused primarily on ways in which legal and business relationships between physicians and hospi­ tals could be made more efficient, economical, and profitable for both physi­ cians and hospitals. norm tabler, senior vice president and general counsel of clarian health partners, claimed that the primary cause of the increasing dysfunction of the traditional hospital-physician relationship is "disaggregation." in episodes of medical care, particularly when it involves a hospital, there is a complete disaggregation of the interests ofhospitals and physicians. the various inter­ ests are not aligned, but competitive and conflicting. steve pratt, a partner at the law firm of hall, render, killian, heath & lyman, was asked to describe different models for the integration of hospitals and physicians, short oftotal integration through physician ownership ofhospi­ tals. he also agreed that, in current relationships between physicians and hospi­ tals, there is a "disconnect" between the authority to make decisions and the consequences of the decisions on the economic side. dennis pippenger, m.d., recounted his experience establishing a man­ agement company at a local hospital that was jointly owned by the surgeons and other surgical specialists with the hospital. this joint venture now manages all the surgical operations at the hospital and employs all the surgery department employees. he pointed out the numerous ways in which this new company was successful, mainly through the alignment of financial interests of the hospitals, providers, and staff. michael finnerty, vice president of kaufinan hall & associates, inc., talked about physician efforts to make medical practice more profitable. he first observed that the force driving physician practice acquisitions in the 1990s was a perception among physicians that they were not getting enough of the health care dollar. he recounted the experience of so-called physician practice management companies in the 1990s and how they were attempting to reorgan­ ize medical practice to reap greater financial rewards for the owner physicians. greg pemberton commented on how these physician practice management companies were the darlings ofwall street in the early 1990s. all they had to do was grow so that they could raise more capital. however, the model disinte­ grated because the management companies were unable to return sufficient dol­ lars to the physician employees who had owned the practices the companies acquired. growth and accounting tricks alone were not enough to keep wall street happy, and so these companies hit a wall. only the single specialty man­ agement companies survived. mike finnerty noted that these single specialty management companies are highly dependent on very expensive equipment and technologies. the suc­ cessful combination for these for-profit medical corporations seems to be pri­ vate capital, management expertise, and a medical specialty organized around 2007] introduction 207 an expensive technology. an example of this phenomenon is us oncology, which now controls a very large proportion of the oncologists in practice in the united states. steve pratt then commented on the impact of hospital contracts with phy­ sician groups when they purchase physician practices in a given community. the hospital locks up local physicians with non-compete clauses in their con­ tracts, which prevent these physicians from providing services to, have owner­ ship in, or receive financial compensation from any other competing group. this state of affairs, steve pratt observed, is somewhat inconsistent with the theory that underlies the nonprofit community-based hospitals to serve the community. while these hospitals have an obligation to remain financially healthy, tying up physicians with non-competes in a way that is good for the hospital but not good for the community is inconsistent with the theory of tax­ exempt organizations. yet this happens all the time, and it is a barrier to get­ ting things done. in closing, it might be appropriate to revive what professor blumstein has called "[ o ]ne traditional view" of hospitals and the medical profession that "suggests that the very introduction of economics into medical care decision making corrupts medical judgment and therefore should be avoided." 3 today' s relationships between physicians and hospitals are all about maximizing finan­ cial returns from both types of providers. yet the financial returns for all pro­ viders are derived primarily from health insurance benefits for individual patients and/or the personal funds of these patients. pricing of services is based on the assumption that most patients, particularly recipients of expensive, tech­ nological intensive care, will have health insurance. further, a third of the in­ suredwho customarily are greater users of health care servicesare insured through public health insurance programs.4 what is rarely discussed in the debate over physician-hospital relation­ ships is the fact that they operate in the context of colossal market failure. over sixteen percent of the u.s. population has no health insurance and even more have inadequate health insurance. 5 and costs of health care services are rising thus threatening the ability of individuals and the sponsors of their health insur­ ance be they private employers or public programs to continue providing affordable health care coverage. the current situation is unsustainable. take indiana as an example. ac­ cording to the analysis of an indiana university faculty work group with whom the state oflndiana has contracted to develop options for health care reform for indiana,6 indiana's health care sector is headed for disaster. in 2004, indiana 3 !d. at 211-12. 4 carmen dena vas-walt, bernadeite d. proctor & cheryl hill lee, income, poverty,andhealtiilnsurancecoverageintheunitedstates:2005(u.s.census,con­ sumer population reports, aug. 2006), at 21 fig. 6. 5 !d. 6 see indiana university healtii care reform faculty work group, a frame208 indiana healtii law review [vol. 4:205 spent 14.4% of its gross state product ("gsp") on health care (compared to 13.3% nationally). between 1995 and 2004, personal health care expenditures in indiana increased 83% while gsp increased only 55%. if these trends con­ tinue unchecked, health care expenditures would constitute half the state's economy by 2035. further, between 2000 and 2004, indiana experienced the second greatest drop in private health insurance coverage in the nation. insured indiana employees are assuming an increasing share of the costs, with their por­ tion of premiums increasing at more than seven times the rate of the increase in wages. indiana's rate of medically-related bankruptcy is the highest in the na­ tion. this is market failure. until health care providers and private health insurers can figure out how to design a market for health care services that assures access for affordable health care services either through direct purchase or affordable insurance, it is inappropriate to focus the debate on how to align economic incentives for hos­ pitals and physicians to maximize their profits. no other market in the u.s. economyexcept defense and possibly educationis so highly dependent on public funds for the economic returns to its producers. financing and deliver­ ing health care services through for-profit structures, which capture excess rev­ enues as profit for shareholders rather than funds to reinvest in expanding access and reducing costs of public programs is problematic. the expectation of profit is only appropriate when the economic actors in a market are able to provide goods and services at affordable prices and without public subsidies for all who seek to purchase those goods and services. work for iiealtii care reform in indiana (2008). joanna sax joanna sax focuses her legal research on policy issues surrounding health law and biomedical research. she received a ph.d. in cell and molecular biology from the university of pennsylvania school of medicine in 2003. in 2006, she received a j.d. from the university of pennsylvania law school. joanna sax is a first year associate at a law firm in san francisco, california. reforming fda policy for pediatric testing: challenges and changes in thew ake of studies using antidepressant drugs joanna k. sax • table of contents l. introduction ................................................................................. 62 ii. historical treatment of children in drug testing impacts regulatory reform ................................................................ 65 iii. legislative history of the acts designed to protect children in the testing and use of fda approved drugs ............................................................................ 66 a. patent exclusivity for voluntarily conducting pediatric trials .......................................................................... 66 b. the fda required pediatric testing under the 1998 final rule .................................................................... 67 c. pediatric testing of both patented and off-patent drugs is permitted under the best pharmaceuticals for children act ......................................................................... 68 d. the pediatric research equity act essentially codified the 1998 final rule ..................................................... 70 iv. the antidepressant story is a model for the deficiencies in the current legislation ................................. 71 a. the for est laboratories clinical studies demonstrate conflicting clinical results ........................................................ 72 b. anecdotal reports regarding selective serotonin re-uptake inhibitors caused the british medical health regulatory agency to ban the use of this class of antidepressant drugs in children ................................ 73 c. the eli lilly clinical studies showed that the fda and researchers must be attentive when taking adolescents off antidepressants ................................................ 74 d. committee hearings addressed antidepressant clinical studies in pediatric populations .................................. 74 v. policy recommendations to address the difficulties associated with pediatric studies ........................................... 76 *j.d., 2006, university ofpennsylvania law school, philadelphia, pennsylvania; ph.d., 2003, cell and molecular biology, university of pennsylvania school of medicine, philadelphia, pennsylvania; b.s., 1997, zoology, university ofwisconsin, madison, wisconsin. the author wishes to thank professor theodore ruger for invaluable comments and criticisms. 62 indiana heal til law review [vol. 4:59 a. public databases that disclose medical device and drug tests by reporting inconclusive or negative clinical trials ..... 76 b. changes should be made to the exclusivity provision .............. 78 c. the new policy should address labeling changes ................... 80 d. the fda should implement additional post-approval surveillance mechanisms ........................................................... 82 vi. conclusion ..................................................................................... 83 i. introduction many physicians "dose down" a drug approved by the food and drug administration ("fda") when prescribing it for children to account for their lower body weight. children, however, may react differently to drugs than adults for a variety of reasons including kidney and liver development. the practice of"dosing down" may not always account for these physiological dif­ ferences.1 indeed, some physicians may worry about adverse side effects when "dosing down" and may opt to prescribe less effective medication that is known not to have serious adverse effects in children. the dilemma presents physi­ cians with a choice, on the one hand, to prescribe a potentially more effective medication and risk adverse side effects because it bas not been tested in pedi­ atric populations, or, on the other hand, to use an older and perhaps less effec­ tive drug. recognizing the problem of safe and effective drug use in children, congress and the food and drug administration (fda) have enacted statutes and regulations respectively, which only begin to address the plethora of prob­ lems associated with prescribing drugs to pediatric populations. it was not until the past decade that congress significantly recognized the need for drug testing in pediatric populations. the first in the line of these leg­ islative schemes was the food and drug administration modernization act of 1997 ("fdama"), which included a pediatric drug exclusivity provision to encourage drug testing in children. 2 although drug companies were not re­ quired to conduct clinical trials in children, the fdama encouraged such drug testing by offering a six-month patent extension period.3 with the impending 2002 sunset provision of the fdama, congress passed the best pharmaceuticals for children act ("bpcn').4 the bpca also 1 jerome groopman, the pediatric gap: why have most medications never been properly tested on kids?, the new yorker, jan. 10, 2005, at 32, 32-35 (describing the myriad of problems associated with administering drugs to pediatric patients). 2 food and drug administration modernization act of 1997, pub. l. no. 105-115, § 111, 111 stat. 2296,2305-09 (1997) (codified as amended at 21 u.s.c. § 355a), amended by best pharmaceuticals for children act, pub. l. no. 107-109, 115 stat. 1408 (2002) (codified in scattered sections of21 u.s.c. and 42 u.s.c.). 3 21 u.s.c. § 355a(b) (2000 & supp. iv 2004). 4 best pharmaceuticals for children act, pub. l. no. 107-109,115 stat. 1408 (2002) (codified in scattered sections of21 u.s.c. and42 u.s.c.). 2007] reforming fda poucy for pediatric testing 63 grants the six-month patent exclusivity extension but goes one step further. 5 if the fda determines more information is needed about a particular drug, it can refer the drug to the national institutes of health (''nlll'') and authorize the nih to collect funds and award research grants to third parties to test the drug.6 the bpca also establishes a public fund that the fda can use to pay a third party directly to conduct the appropriate tests. 7 the results of these tests must then be reported back to the fda. 8 the bpca, however, sunsets in 2007.9 on the heels of the fdama, the fda promulgated the 1998 "pediatric rule," which allowed the fda to require pediatric testing on already marketed drugs and require pediatric testing and labeling of new drugs.10 pharmaceutical companies, however, could request a full or partial waiver of this requirement 11 in october 2002, a united states district court for the district of columbia struck down the 1998 pediatric rule as incompatible with the bpca and ex­ ceeding the authority of the fda under the food drug and cosmetic act ("fdca'').12 shortly after the court's decision, congress passed the pediatric research equity act of2003 ("prea").13 the prea codified the "pediatric rule," and it will sunset in 2007.14 the importance of regulated pediatric clinical trials is underscored by medical discoveries that adults and children react differently to certain medica­ tions. one malady present in both the pediatric and adult population is depres­ sion. although exact biological differences between adult and pediatric depression are unclear, some experts believe they are not identical and therefore antidepressant medications may work differently in a developing brain.15 for example, in 2003, the british government concluded that seroxat (known as s 21 u.s.c. § 355a(b) (supp. iv 2004). 6 42 u.s.c. §284m( a )-(b) (supp. m 2003). 7 id §§ 284m(cxl), {d). 8 id § 284m(cx6xa). 9 21 u.s. c. § 355a(n) (supp. iv 2004) (sunset date is oct. 1, 2007). 10 regulations requiring manufacturers to assess the safety and effectiveness ofnew drugs and biological products in pediatric patients, 63 fed. reg. 66,632, 66,639 (dec. 2, 1998) (to be codified at21 c.f.r pts. 201,312,314, and 601). 11 21 c.f.r. §§ 314.55(cx1)-(4), 601.27{cx1)-(4)(2006). see also ass'n of am., phy­ sicians & surgeons, inc. v. fda, 226 f. supp. 2d 204, 208 (d.d.c. 2002). 12 ass 'n of am., physicians & surgeons, inc., 226 f. supp. 2d at 220-21 (describing that the "pediatric rule" was neither accepted nor rejected by congress when adopting the bpca and that the "pediatric rule" exceeds the fda's statutory authority). 13 pediatric research equity act of2003, pub. l. no. 108-155, 117 stat 1936 (codified as amended at 21 u.s.c. § 355c (supp. iv 2004)). 14 /d.; groopman, supra note 1, at 35 ("in 2003, congress passed legislation that codi­ fied what is known as the pediatric rule .... [t]he reforms include a 'sunset clause' ... (this clause was added as a result of pressure from drug companies and groups that oppose govern­ ment regulation.)"). 15 groopman, supra note 1, at 34 ("although the precise biological differences between adult depression and childhood depression are not yet known, there is reason to believe that the maladies are not identical, and that antidepressants may work differently on a developing brain."). 64 indiana realm law review [vol. 4:59 paxil in the united states) should not be prescribed to children because of in­ creased suicidal behavior and withdrawal symptoms.16 the fda followed suit --but not until ten months later.17 eli lilly recently received bad press when college student traci johnson committed suicide after moving from the antidepressant cymbalta to a placebo during a clinical trial for treatment of depression, thus highlighting the potential problem of withdrawal from a drug.18 although the fda cleared eli lilly of wrongdoing, 19 this tragic episode highlights some problems associated with pediatric testing. indeed, at about the same time, the fda reported the results of a 2004 study indicating that twice as many children taking antidepressants had suicidal behavior compared to children taking placebos.20 this study ex­ emplifies the need for heightened monitoring of children in pediatric studies­ because pediatric populations may react differently than adult populations. despite both fda and congressional attempts to address the problems of prescription drug use in children, several deficiencies and loopholes exist. thus, conducting clinical trials in this vulnerable population must be highly regulated. part ii briefly introduces that the historical treatment of children im­ pacts regulatory reform. part m will explain the evolution of regulatory and legislative approaches to pediatric drug testing, highlighting how each new leg­ islative program contained special precautions to widen the number of drugs tested in children and also protected children as participants in clinical trials. part n, however, demonstrates how these statutory and regulatory provisions have failed to address the use of antidepressant mediation in pediatric patients. in response to learning that pediatric populations may be at risk when taking antidepressant mediation, congress held hearings to determine whether the fda and drug manufacturers were conducting and publicizing the results of positive, negative, and inconclusive clinical trials. as the sunset date of the current programs approaches, new policy changes are proposed in part v for consideration as the fda moves forward. while the recent legislative schemes offer some protection to children as clinical subjects, they do not provide enough protection once the drug is on the market. legislative and policy re­ forms might include the following: public disclosure of all clinical trials, 16 /d. at 35 (describing that in the 1980s. 1990s. and 2000s, the british government monitored reports of selective serotonin re-uptake inhibitors and ultimately concluded they were not safe for use in children). 17 e.g.,id 18 /d. at 34 ("indeed, eli lilly and company recently received a tremendous amount of bad press when traci johnson, an indiana college student. committed suicide during a clinical trial ofcymbalta, an antidepressant."). 19 e.g., id.; u.s. finds no link between a suicide and a lilly drug, n.y. times, aug. 13, 2004, at c4. 20 groopman, supra note 1, at 34 ("johnson's death occurred at the same time that the f.d.a. was analyzing a large set of data compiled from multiple clinical trials. the results, which were released in october, indicated that twice as many children taking antidepressants in clinical trials considered or attempted suicide as children taking placebos."). 2007] reforming fda policy for pediatric testing 65 changes in the exclusivity provision, labeling changes, and post-approval drug surveillance. ii. historical treatment of children in drug testing impacts regulatory reform historically, children were used as subjects in medical experiments. 21 un­ til the later part of the twentieth century, the government made few efforts to regulate pediatric testing, and children were often forced to participate in dan­ gerous tests. 22 in addition, the testing among pediatric populations usually fo­ cused on understanding a disease, rather than testing new drugs that could be used to treat it. children need protection from medical mistreatment. this set of ethical concerns, regarding the protection of children entering a clinical trial, includes issues such as consent, protection of disabled children, and associated health risks. a thorough discussion of the ethical dilemmas regarding children in clinical trials is beyond the scope ofthis article, but a large body oflaw review articles specifically addresses this difficult and critical area. 23 clinical trials for safe and effective treatments of childhood ailments need to be conducted. this article focuses on this set of issues that concerns the testing of pediatric drugs to determine whether they are safe and effective for pediatric populations. as described above, because relatively few drugs are tested on pediatric populations, doctors tend to "dose down" adult dosages to account for the lower body weight in children. children, however, have physiological differences that may cause a drug to metabolize differently. gov­ ernment regulations aimed at promoting and even requiring drug testing in children are necessary to ensure the safe and effective use of drugs in pediatric populations. described below are the current legislative and regulatory schemes addressing such drug experimentation in pediatric populations. al­ though these schemes are a good starting point to address the problems of drug testing in children, they do not go far enough. 21 see generally susan e. lederer & michael a. grodin, historical overview: pediatric experimentation, in children as research subjects: science, elhics,and law 3, 3-20 (mi­ chael a. grodin & leonard h. glantz eds., 1994). 22 lauren hammer breslow, note, the best pharmaceuticals for children act of2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing, 40 harv. j. onlegis.133, 135-41 (2003); lederer& grodin, supranote2l (describ­ ing children as research subjects in eighteenth, nineteenth, and twentieth centuries); leonard h. glantz, the law of human experimentation with children, in children as research subjects: science, elhics, and law 103, 103 (michael a. grodin & leonard h. glantz eds., 1994) [hereinafter glantz, the law of human experimentation with children] (explaining that until the last half of the twentieth century virtually no regulations governed pediatric testing). 23 see, e.g., carrie fisher & thomas g. keens, participation of children in research, 26 whitiler l. rev. 823 (2005); glantz, the law of human experimentation with children, supra note 22; leonard h. glantz, research with children, 24 am. j .l. & med. 213 ( 1998). 66 indiana health law review [vol. 4:59 iii. legislative history of the acts designed to protect children in the testing and use of fda approved drugs in 1997, congress enacted the fdama, which, although affecting nu­ merous fda regulations, also has been the first congressional action to address specifically the problems of testing new drugs in children.24 the fdama was followed by key regulations and subsequent congressional acts focusing on the emerging recognition of the need for pediatric drug testing. a. patent exclusivity for voluntarily conducting pediatric trials the fdama significantly changed the regulatory scheme for pediatric testing. most notably, it granted pharmaceutical companies a six-month patent extension in.exchange for conducting pediatric trials of their drug.25 the patent exclusivity provision applied only to future or existing patented drugs.26 that is, if a drug company was outside the exclusive period provided by the patent, pediatric clinical trials for that particular drug would not give the pharmaceuti­ cal company an exclusive six-month market. the market exclusivity approach is similar to the hatch-waxman act, which allows patent extensions for drugs in order to compensate for the time the drug is moving through the regulatory process. 27 prior to the hatch­ w axman act, a pharmaceutical company would receive a patent for its drug before completing the fda regulatory approval process but could not market the drug until the fda approved it. therefore, the company would not be able to enjoy the market exclusivity granted by the patent while the drug was in the regulatory pipeline. the hatch-waxman act allows a patent extension tacked on to the end of a drug's patent term to compensate for the delay experienced during the approval process.28 providing patent extensions for voluntary pediatric drug testing has been described as a "carrot and stick" approach.29 the "carrot" is the six-month 24 see generally food and drug modernization act of 1997, pub. l. no. 105-115, § 505a, ill stat. 2296,2305-09 (1997) (codified as amended at 21 u.s.c. § 355a). while the fda attempted to regulate pediatric research studies through enactment of rules, the fdama of 1997 is the first congressional act to specifically address pediatric drug research. id see chris­ topher-paul milne, exploring the frontiers of law and science: fdama 's pediatric studies incentive, 51 fooo&drugl.j. 491,491 (2002) (describingthepushforthebetterpharmaceu­ ticals for children act and its incorporation into the fdama); breslow, supra note 22, at 15155 (describing steps taken by the fda to regulate pediatric testing but also noting that congress enacted the fdama which overhauled the fdca). 25 21 u.s.c. § 355a(b) (2000 & supp. iv 2004); see breslow, supra note 22, at 155-57 (discussing the market exclusivity provision). 26 21 u.s.c. § 355a(b) (applying to both new drugs and already-marketed drugs). 27 21 u.s.c. § 355 (2000 & supp. ill 2003); 35 u.s.c. § l56(a)(4) (2000). 28 21 u.s.c. § 355. 29 kurt r. karst, comment, pediatric testing of prescription drugs: the food and drug administration's carrot and stick for the phaimaceutical industry, 49 am. u.l. rev. 2007] reforming fda policy for pediatric testing 67 market exclusivity granted to pharmaceutical companies, beyond the granted patent time period, that conduct pediatric clinical trials voluntarily.30 this mar­ ket exclusivity provision could potentially allow pharmaceutical companies to make millions of dollars for heavily prescribed drugs. the "stick" is the fda rule that requires companies to assess the safety and effectiveness of the drug in pediatric populations. 31 at that time, a second provision of the fdama stated that the secretary is "to develop a list of drugs for which additional pediatric information may be beneficial. "32 under this provision, the secretary is to publish a prioritized list of fda approved drugs that are deemed to need clinical testing in pediatric patients. 33 this list is to be updated annually. 34 another provision applied to conducting pediatric studies. 35 this provision discusses the protocols and time frame for the requirements of pediatric clinical studies.36 the bpca, enacted in 2002, addressed and changed section 111 and is discussed in greater detail below. b. the fda required pediatric testing under the 1998 final rule the fda also proceeded on its own course to regulate drug testing in pe­ diatric patients and promulgated the 1998 final rule.37 the 1998 final rule acknowledged the market exclusivity provision in the fdama. the fda rule, however, went beyond the voluntary pediatric testing requirement in the fdama by allowing the fda to require pediatric testing of already approved and marketed drugs and to favor pediatric testing in new drugs.38 in compiling the pediatric list, the fda included all drugs that are approved for use in 739, 739, 743-44 (2000) (describing the "carrot and stick" approach). 30 karst, supra note 29, at 743-44; see breslow, supra note 22, at 155 (describing the six-month patent extension as a "financial boom for manufacturers"). 31 karst, supra note 29, at 744; cf christopher-paul milne, supra note 24, at 495 ("seemingly taking their cue from the stance of the executive office, some members of con­ gress accused fda of playing 'hide the carrot' by requesting only a small number of pediatric trials under fdama. at the same time, the agency ostentatiously waved the stick by reportedly stating that, if the opportunity offered by the fdama incentives went unanswered, fda would 'consider exercising its authority to require studies.'"). 32 food and drug administration modernization act of1997, pub. l. no. 105-115, § 505a(b ), ill stat. 2296, 2306 (1997)(codified as amended at 21 u.s.c. § 355a); see breslow, supra note 22, at 156. 33 food and drug administration modernization act of 1997 § 505a(b). 34 !d. 35 !d. § 505a(d), 111 stat. at 2307. 36 !d. § 505a(d)(2). 37 regulations requiring manufacturers to assess the safety and effectiveness ofnew drugs and biological products in pediatric patients, 63 fed. reg. 66,632, 66,633 (dec. 2, 1998); see generally breslow, supra note 22, at 159-63 (discussing the final rule). 38 regulations requiring manufacturers to assess the safety and effectiveness ofnew drugs and biological products in pediatric patients, 63 fed. reg. 66,632, 66,634 (dec. 2, 1998). 68 indiana health law review [vol. 4:59 adults for a disease or condition that occurs in children. 39 the fda also re­ quires new drugs that had a high probability of use in pediatric populations to undergo pediatric testing.40 under the 1998 final rule, pharmaceutical companies could request a waiver for pediatric testing.41 to receive a waiver, the fda must be satisfied that (1) the drug did not provide a therapeutic benefit over the existing treat­ ment and (2) the drug would not be used in a substantial number of pediatric patients.42 if a company did not receive a waiver, the fda could file an action in federal court seeking an injunction based on the manufacturer's noncompli­ ance.43 the court could then require the manufacturer to assess the safety and effectiveness of the drug in pediatric populations. 44 in addition, the fda separated the pediatric population into the fqllowing arbitrary age groups: neonates (up to one month old); infants (one month to two years old); children (two to twelve years old); and adolescents (twelve to six­ teen years old).45 these age ranges, however, do not necessarily account for physiological differences. moreover, older teenagers and young adults may still undergo developmental changes. issues regarding these age groups are further discussed below. c. pediatric testing of both patented and off-patent drugs is permitted under the best pharmaceuticals for children act when enacted, section 111 of the fdama was set to sunset in 2002. in 2002, however, congress enacted the best pharmaceuticals for children act ("bpca"), 46 which includes the market-exclusivity provision in the fdama 39 fda docket no. 98 n-0056, list of drugs for which additional pediatric informa­ tion may produce health benefits in the pediatric population 1, 1-3 (may 20, 1998); see mi­ chael s. labson, pediatric priorities: legislative and regulatory initiatives to expand research on the use of medicines in pediatric patients, 6 j. health carel. & pol'y 34, 47 (2002) (describing the pediatric list). 40 see labson, supra note 39, at 48 (2002). 41 regulations requiring manufacturers to assess the safety and effectiveness ofnew drugs and biological products in pediatric patients, 63 fed. reg. 66,632 (dec. 2, 1998) (codi­ fied at 21 c.p.r. pts. 201, 312,314, and 601 (2006)). 42 21 c.p.r.§§ 314.55(c)(2)(i), 601.27(c)(2)(i) (2002). see labson, supra note 39, at 54 (describing the waiver provision). 43 regulations requiring manufacturers to assess the safety and effectiveness ofnew drugs and biological products in pediatric patients, 63 fed. reg. 66, 632, 66,636 (dec. 2, 1998); see labson, supra note 39, at 56 (describing enforcement). 44 see 21 c.f .r. §§ 201.23, 601.27 (2006) (requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients). see also labson, supra note 39, at 56 (describing the enforcement mechanism). 45 william j. rodriguez, sci. dir. for pediatrics, fda, cder 's experience: what we have learned from the pediatric initiative (feb. 20, 2002), available at http://www.fdagov/cderlpediatriclpresentatioolped_ init _ rodriguezlsld024.htm (microsoft office powerpoint slide no. 24). 46 best pharmaceuticals for children act, pub. l. no. 107-109, 115 stat. 1408 (2002) 2007] reforming fda poucy for pediatric testing 69 and also addresses some criticisms of the fdama.47 unlike the fdama, the bpca addresses the testing of both on-patent and off-patent drugs. under the bpca, the nih, in collaboration with the fda, develops lists of drugs that need additional studies to assess the safety and effectiveness in pediatric popu­ lations. 48 the nih considers the following criteria to determine whether pedi­ atric testing is needed: "(1) availability of infonnation conceming the safe and effective use of the drug in the pediatric population; (2) whether additional in­ fonnation is needed; (3) whether new pediatric studies concerning the drug may produce health benefits in pediatric population; and ( 4) whether refonnation of the drug is necessary.'..-9 once the list is compiled, the fda sends a written request to the manufacturer of each drug to request the pediatric studies. 50 if the fda does not receive a response from the manufacturer within thirty days, then the fda will publish a request for third parties, who themselves meet par­ ticularized criteria for conducting pediatric trials, to conduct the studies. 51 once the pediatric studies are conducted, either the manufacturer or the third party submits a report that includes all data generated in the study. 52 the fda then reviews the report and begins a negotiation process with the manu­ facturer regarding labeling changes. 53 if the manufacturer does not agree to a labeling change, the labeling request is referred to the pediatric advisory committee to review the information and make a recommendation regarding the appropriate labeling changes, if any. 54 the fda then contacts the manufac­ turer with the committee's request. 55 if the manufacturer does not comply within thirty days, the fda may deem the drug misbranded and bring an en­ forcement action in federal court. 56 the bpca also addressed many of the ethical dilemmas involved with conducting pediatric research. first, the bpca establishes the office ofpediat­ ric therapeutics within the fda to coordinate and facilitate activities related to pediatric issues. 57 second, the bpca establishes a procedure for contracting with the institute ofmedicine ("10m'') to review pediatric studies. 58 the 10m (codified as amended in scattered sections of21 u.s. c. and 42 u.s.c.). 47 42 u.s.c. § 284m(a)(2000&supp. iii2003){clarifyingtheapplicationofthepediat­ ric exclusivity provision under section 505a of the federal food, drug, and cosmetic act); see also breslow, supra note 22, at 173-74 (describing the bpca as "a greatly matured successor to the ori~ pediatric exclusivity provision of the fdama.''). 8 program for pediatric studies of drugs, 42 u.s.c. § 284m( a) (supp. iii 2003); see breslow, supra note 22, at 174-77 (describing the program for pediatric studies of drugs). 49 42 u.s.c. § 284m(ax2). 50 /d. § 284m(bxc). 51 see id. § 284m(cx2). 52 see id § 284m(cx6xa). 53 see id § 284m( c x7). 54 see id § 284m(cx8). 55 /d. § 284m(cx9). 56 see id. §§ 284m(cx10)-(ll). 51 21 u.s.c. § 393a(a)-(b)(supp. iv2004); seebreslow,supranote22, at 178-79(describin~ "structural administrative changes"). · 8 best pharmaceuticals for children act, pub. l. no. 107-109, 115 stat. 1416 (2002) 70 indiana health law review [vol. 4:59 is to review numerous areas including assent, informed consent, benefits and risk, "minimal risk," and the role of the institutional review board in conducting the trial. 59 the bpca also contains an october 1, 2007, sunset clause.60 with the enactment of the bpca, the bush administration suspended the 1998 final rule in may 2002.61 in response, the department of health and human services ("hhs") announced the bpca and the 1998 final rule could coexist but asked for public comment regarding what steps to take for the fda to accommodate the bpca.62 the common ground hhs asked for never came to fruition because, in 2002, the district court for the district of columbia held the 1998 final rule"[ exceeded] the fda's statutory authority and [was] there­ fore invalid.'o63 d. the pediatric research equity act essentially codified the 1998 final rule in response to the district court's decision, in 2003 congress amended the fdca by enacting the pediatric research equity act ("prea"). 64 the prea essentially codifies the 1998 final rule and specifically grants the fda the authority to require pediatric testing of new and already approved drugs. 65 for new drug applications, the fda has the authority to grant manufac­ turers either a full or partial waiver for pediatric testing. a full waiver for new drugs is allowed in the following circumstances: (1) when a small patient popu­ lation makes studies practically impossible; (2) when evidence suggests the drug will be ineffective or unsafe for all pediatric ages; (3) when the drug does not represent a meaningful benefit over existing therapies; or ( 4) when the drug will not be used in a substantial number of pediatric patients. 66 a partial waiver for new drugs may be granted for particular age groups for the same reasons as described for granting a full waiver, but granting a partial waiver also requires the manufacturer to show that reasonable attempts to produce a pediatric formu(codified at42 usc§§ 289 note(a), note(b)); 42 u.s.c. § 289 note(a)(supp. iii 2003). 59 42 u.s.c. § 289 note(b). 60 21 u.s.c. § 355a(n) (supp. iv 2004). 61 breslow, supra note 22, at 185 ("(i]n may 2002, the bush administration decided to suspend the rule in light of the bpca's comprehensive structure."). 62 id ("hhs announced that the bpca and the 1998 final rule could coexist, but also asked for public comment on 'what additional steps [the fda could] take to assure adequate study of drugs in children in light of' the bpca "). 63 ass'n of am., physicians & surgeons, inc. v. fda, 226 f. supp. 2d204, 222 (d.d.c. 2002). 64 pediatric research equity act of2003, pub. l. no. 108-155, 117 stat 1936 (codified as amended at 21 u.s.c. § 355c (supp. iv 2004)). 65 21 u.s.c. § 355c(a)-(b) (supp. iv 2004); groopman,supranote 1, at35 ("in 2003, congress passed legislation that codified what is known as the pediatric rule. a drug company working on a new treatment for a disease that affects both adults and children is now required to conduct pediatric studies."). 66 21 u.s.c. § 355c(a)(4xa). 2007] reforming fda poucy for pediatric testing 71 lation for a particular age group have failed. 67 for already approved drugs, the prea grants the fda authority to re­ quire pediatric studies if the drug is used in a substantial number of pediatric patients for uses indicated on the label, the absence of pediatric labeling poses significant risks, and data suggest the drug will represent a meaningful thera­ peutic benefit over existing therapies.68 the fda can grant a full waiver for pediatric studies if the studies are practically impossible to complete or there is strong evidence the drug would be unsafe or ineffective in all pediatric popula­ tions.69 a partial waiver for particular age groups for already approved drugs may be granted for the same reasons as a full waiver. 70 in addition, a partial waiver for a particular age group will be granted if the fda determines four criteria: (1) the drug will not represent a meaningful therapeutic benefit over existing treatment; (2) the drug is not likely to be used in a substantial number of pediatric patients in a particular age group; (3) the absence oflabeling does not pose a significant threat; and ( 4) the manufacturer can demonstrate that rea­ sonable attempts to produce a formula for that age group have failed.71 the drug label must indicate whether a waiver has been granted. 72 upon passage, senator dodd addressed the senate to explain that the main point of the prea is to give the "fda the clear authority to require that drugs be tested and formulated for children."73 like the bpca, the prea will sunset in 2007.74 iv. the antidepressant story is a model for the deficiencies in the current legislation although the bpca and the prea provide for the identification of drugs that need to be tested in pediatric patients and offer protection for children en­ tering clinical studies, they do not go far enough to address many other health and safety concerns. the controversy surrounding the use of antidepressant medication in pediatric patients offers a good case study to analyze the defi­ ciencies in the current legislative scheme. as is often the case, it may be diffi­ cult to cover all areas ex ante when promulgating legislative and regulatory schemes. over the past few years, tests of multiple antidepressant medications in pediatric patients revealed antidepressants either did not work, induced sui­ cidal behavior, or caused withdrawal symptoms when the patient was taken off 67 id. § 355c(a)(4)(b). 68 id. § 355c(bxi). 69 id. § 355c(bx2xa). 70 i d. § 355c(b x2)(b). 71 jd. §§ 355c(bx2)(bxiii)(aa), (bb), (iv). 72 id. § 355c(bx2xd). 73 149 con. rec. s9811, s9818 (2003). 74 21 u.s. c. § 355a(n) (referring to amendment of21 u.s.c. 351 et seq.). 72 indiana health law review [vol. 4:59 the drug. 75 indeed, reports surfaced that some drug manufacturers may have known about the ineffectiveness or even negative effects of antidepressants for years.76 the fda's authority to require pediatric testing may have brought some of the negative effects of antidepressant drug use in children to light, but the regulatory scheme was neither able to address anecdotal information effec­ tively, follow-up on manufacturer's information in clinical studies, nor respond quickly to developments in sister organizations in other countries. therefore, the antidepressant story can be used to highlight where the deficiencies in pedi­ atric testing exist and mark a good starting point to broaden the fda's regula­ tory authority to protect children. a. the forest laboratories clinical studies demonstrate conflicting clinical results in the spring of2004, forest laboratories announced that its antidepres­ sant drug, lexapro, did not help depressed pediatric patients.77 lexapro con­ tains the same active ingredient as celexa. 78 the patent on celexa is about to expire and it has been reported that perhaps forest laboratories is promoting lexapro so as to make money during the patent exclusivity time period. 79 in the wake of the lexapro announcement, forest laboratories also addressed its inadequate disclosure of a failed unpublished study in 2002 regarding use of celexa in children. only now, forest laboratories stated that a more recent 2004 test indicates celexa may indeed help children. the results of the study, which was conducted in eur':e from 1996 to 2002, showed celexa had no greater effects than a placebo. that study, however, was published in a dan­ ish textbook and therefore received little attention. 81 two of the outside re­ searchers involved in the positive study on celexa stated they did not know 75 barry meier, drug maker acknowledges some negative test results, n.y. times, june 26, 2004, at c3 [hereinafter meier, negative test results); groopman, supra note 1, at 356. 76 meier, negative test results, supra note 75 (stating that forest officials had not told a medical journal about a failed unpublished study in 2002 regarding the use ofcelexa in children and adolescents prior to the medical journal's publication of an article about a separate test indi­ cating the drug could help young people. further, some of the authors of this article were forest employees.). 77 !d. ("forest laboratories has said a recently concluded test found that its antidepres­ sant lexapro did not help depressed children and adolescents, an announcement that comes amid the growing controversy over clinical drng tests. j. 78 id. 79 /d. 80 id. 81 /d. ("the european study was sponsored by h. lundbeck, the danish company that developed citalopram, which forest markets in this country as celexa. j. the basic finding of that study, which reported that celexa "showed no effects greater than a placebo-was noted in a chart published" in october 2003 in a medical textbook written in danish. jd 2007] reforming fda poucy for pediatric testing 73 about the results of the earlier study. 82 the lexapro and celexa clinical studies raise a number of concerns. first, forest laboratories has not explained the discrepancies between the ear­ lier study of celexa that found no greater effect than a placebo and the more recent study that concluded the drug could help pediatric patients. second, it is disconcerting that previous tests regarding the efficacy of celexa in pediatric patients were not disclosed in a major medical or pharmaceutical journal or to the fda. third, the results of the lexapro study showing that lexapro did not help depressed pediatric patients is inconsistent with the recent positive results in the celexa study because they contain essentially the same active ingredient. perhaps other factors in the design of the clinical study contributed to the dif­ ferences in the results. this suggests a more comprehensive scheme is needed to regulate the design of pediatric trials. the fda appears inept at addressing the information obtained from these clinical trials. b. anecdotal reports regarding selective serotonin re-uptake inhibitors caused the british medical health regulatory agency to ban the use of this class of antidepressant drugs in children another class of antidepressant drugs, selective serotonin re-uptake in­ hibitors ("ssris"), has caused negative effects in pediatric patients. in the late 1980s, the british medical health regulatory agency ("bmhra"), which is the british counterpart to the fda, began monitoring reports of suicidal behav­ ior and withdrawal symptoms among minors. 83 the british government issued warnings in 1993 and 2000.84 in june 2003, the bmhra convened an emer­ gency meeting and concluded the drug should not be used for pediatric pa­ tients. 85 the united states followed suit ten months later and banned doctors from prescribing paxil to children. 86 this ten-month delay prompted, in part, a congressional investigation into the fda with respect to pediatric testing. 87 the situation with paxil raises additional concerns. first, why did it take 82 /d. two outside researchers involved in the positive celexa study also said in recent interviews that forest did not tell them about the efficacy findings of the european study and that they were not independently aware of them. /d. 83 groopman, supra note 1, at 35 ("in the late nineteen-eighties, britain's medical regu­ latory agency began closely monitoring anecdotal reports of suicidal behavior and withdrawal symptoms related to one class of antidepressants .... "). 84 id. 85 id. ("in june, 2003, the agency convened an emergency meeting to review pediatric trial data on seroxat, and s.s.r.i. known in the united states as paxil, and concluded that the drug should not be prescribed for minors.j. 86 jd. (''ten more months passed before the f.d.a. took similar action on children and antidepressants."). 87 publication and disclosure issues in antidepressant pediatric clinical trials: hear­ ing before the subcomm. on oversight and investigations of the h. comm. on energy and com­ merce, 1 08th cong. (2004) [hereinafter hearing on antidepressant pediatric trials] (statement of u.s. rep. greg walden of oregon). 74 indiana health law review [vol. 4:59 over ten years of anecdotal reports suggesting serious negative consequences before the united states decided to ban the use of paxil in pediatric popula­ tions? this suggests the fda does not collect and react to anecdotal reporting effectively. the prea is a good start to grant the fda authority to require clinical trials for drugs used in pediatric populations. the fda, however, must be capable of responding on various fronts in addition to requiring pediatric studies. second, why did the united states take ten months to ban pediatric prescriptions after the bmhra concluded its emergency study? the fda should have the capability to combine resources with its sister organizations in · other countries. third, why does the fda appear to have such a difficult time determining drug safety in pediatric patients? c. the eli lilly clinical studies showed that the fda and researchers must be attentive when taking adolescents off antidepressants eli lilly recently made headlines when traci johnson, a college student, committed suicide after being switched to a placebo in a clinical trial of cym­ balta. 88 the severe depression, leading ultimately to suicide, was believed to be caused by "hallucinations and paranoid delusions [that] can occur when a pa­ tient is withdrawn from an antidepressant. '.s9 although eli lilly officially was cleared of all wrongdoing, this experience begs at least two questions: (1) what were the deficiencies in the clinical design of the cymbalta trial, if any, and (2) how can the fda ensure this tragedy will not be repeated? the cymbalta study indicates that children may still be undergoing developmental changes until their late teens or early twenties. the fda should consider redefining their pediatric age groups to include college-age students.90 the bpca allows for the 10m to oversee many of the ethical concerns regarding pediatric research and to coordinate with institutional review boards ("irbs"). although this is a good move toward addressing the ethical prob­ lems associated with pediatric research, it appears that anecdotal reporting of withdrawal symptoms may not have been inco:rporated into pediatric trials. the policy recommendations described in part v may allow a larger breadth of in­ formation for the fda, the 10m, and the irbs to use when establishing and conducting pediatric trials. d. committee hearings addressed antidepressant clinical studies in pediatric populations in 2004, committee hearings commenced to address pediatric trials, and 88 groopman, supra note 1, at 35. 89 i d. at 34 (describing the cymbalta study and stating the fda cleared eli lilly of wrongdoing). 90 cf. rodriguez, supra note 45 (identifying pediatric age groups up through age six­ teen). 2007] reforming fda poucy for pediatric testing 75 the house representatives learned the fda knew that twelve of :fifteen pediatric trials of antidepressant drugs proved that the drugs were ineffective. 91 more­ over, only three of the fifteen studies were published.92 representative joe bar­ ton of texas stated, [m]any people want to know what was in the other 12 studies? what do these studies show? why haven't those other 12 studies been published in peer reviewed journals? was there sufficient information available to the public about these un­ published studies to make informed decisions?93 the committee hearing focused on the problems of disclosure in clinical trials. one proposed bill would require manufacturers and researchers to regis­ ter with an online database as a prerequisite for irb approval. 94 this database would then include the results of all clinical trials whether positive, inconclu­ sive, or negative. the proposed bill would give the fda authority to require this registration and noncompliance would be enforced through civil penal­ ties. 95 the reporting system would give clinicians all the relevant information needed to make informed decisions. 96 in addition, the committee noted that only one antid:pressant medication, prozac, is approved for treating depression in children.9 four other drugs, however, are prescribed to children with depression in greater frequency than prozac.98 this is particularly troubling because studies suggest that children taking some antidepressants are 1.89 times more likely to have suicidal thoughts than those given a placebo.99 this highlights the importance of con­ ducting clinical trials for all antidepressant medications used to treat childhood depression and establishing post-market-approval surveillance to determine whether additional side effects are present. 91 hearing on antidepressanj pediatric trials. supra note 87, at 30 (statement ofu.s. rep. greg walden of oregon). 92 id. at 1 (statement ofu.s. rep. joe barton oftexas, chairman, subcomm. on over­ sight and investigations). 93 id. (statement ofu.s. rep. joe barton oftexas, chairman, subcomm. on oversight and investigations). 94 id. at 13 (statement ofu.s. rep. edward markey ofmassachusetts). 95 1d. (statement ofu.s. rep. edward markey ofmassachusetts). 96 id. (statement ofu.s. rep. edward markey ofmassachusetts). 97 id at 39 (statement ofjanet woodcock, fda deputy commissioner of operations). 98 id. at 218 (statement ofu.s. rep. greg walden of oregon, vice chairman, subcomm. on oversight and investigations). 99 id. at 7 (statement ofu.s. rep. greg walden of oregon, vice chairman, subcomm. on oversight and investigations). 76 indiana healtii law review [vol. 4:59 v. policy recommendations to address the difficulties associated with pediatric studies pediatric clinical studies are needed to determine safe and effective doses in children. the protocol of"dosing down" adult prescriptions to account for the smaller size of children does not address physiological differences between adults and children. medications that may be safe for use in adults could be quite unsafe in children. children should not be put at risk when a comprehen­ sive program can be instituted to address their particularities. although the fdama, bpca, and prea are good starting points with their particular em­ phasis on the treatment of children engaged in a clinical trial, specific changes and further regulation are needed to protect pediatric patients. as the fda comes under increased scrutiny following the wake of the an­ tidepressants and vioxx 100 scandals, the time is ripe to address obvious and no­ table deficiencies in the current regulatory scheme. moreover, because the act will sunset in 2007, new policy changes need to be implemented. a variety of policy recommendations should be considered as both congress and the fda move forward to meet these challenges. policy suggestions include the follow­ ing: (1) listing the trials of drugs in public databases and including reports of inconclusive or negative clinical trials, (2) changing the exclusivity provision, (3) labeling changes, and ( 4) implementing effective post-approval surveillance mechanisms. a. public databases that disclose medical device and drog tests by reporting inconclusive or negative clinical trials the fda should establish a public database that lists all drugs, clinical trials, and results of the clinical trials. the american medical association ("ama") and other medical groups are placing pressure on the fda to estab­ lish a database where clinical trials can be tracked from beginning to end.101 in addition, some medical journals are contemplating requiring manufacturers to 100 see gina kolata, merck and vioxx: the overview, n.y. times, oct. 1, 2004, at ai; gardiner harris, drug-safety reviewer says f.d.a. delayed vioxx study, n.y. times, nov. 4, 2004, at a21; anna wilde mathews & barbara martinez, warning signs: e-mails suggest merck knew vioxx 's dangers at early stage; as heart-risk evidence rose, qlficials played hardball; internal message: 'dodge!'; company says 'out of context,' wall st. j., nov. 1, 2004, atal; eric j. topol, failing the pubic healthrofecoxib, merck, and the fda, 351 n. eng. j. meo. 1707, l 707-09 (2004 ). 101 see meier, negative test results, supra note 75 ("the american medical association has called on the federal government to create a database in which trials can be tracked from start to finish."); see also barry meier, medicine's data gap: when labels mislead; results of drug trials can mystify doctors through omission, n.y. 'dmes, july 21, 2004, at cl ("in recent weeks, the academy and other medical groups have met with lawmakers to discuss possi­ ble legislation requiring companies to list tests of drugs and medical devices in a public data­ base."). 2007] reforming fda poucy for pediatric testing 77 register their clinical trials with the journal as a prerequisite to publication.102 although this type of policy reform could be applied to the fda as a whole, perhaps a smaller sample size that is focused on pediatric trials will allow the fda to learn how to manage this type of public database before expanding it to every clinical trial. to date, if a pharmaceutical company performs a clinical study in which the results show the drug is not helpful for a particular condition, then the clini­ cal study is often not published. for example, if a manufacturer conducts a clinical trial to determine whether its fda-approved drug for headaches may also be beneficial for muscle aches, but the results of the study show that the drug is not clinically helpful for muscle aches, then the study may not be re­ ported. in this example, no negative side effects are reported, so it may not cause a public health hazard. although it may not harm a person to take the headache medicine for a muscle ache, would it not be helpful for that person to at least know that the test has been conducted? what if the pharmaceutical company learned in its study that its fda­ approved drug indeed causes muscle aches? is the pharmaceutical company now required to publish the results of the negative study? to date, the pharma­ ceutical company must make the results of its study known to the fda, but nei­ ther the pharmaceutical company nor the fda seems to disseminate the results.103 in addition to labeling requirements, pharmaceutical companies should be required to publish the results of clinical studies that have negative clinical results on a particular patient population in a public database. in addition to the failure to report negative or inconclusive clinical trials, a recent study suggests that a publication bias exists for studies funded by phar­ maceutical companies.104 it appears that journals are more likely to a publish research supported by drug companies compared with clinical trials unsup­ ported by drug companies.105 if this is true, then a public database of all clini­ cal trials and their results should be available to the public. this will allow physicians to receive unfiltered information and then narrow their drug choice when prescribing medications to patients. the lexapro and celexa clinical studies illustrate the importance of this type of information dissemination. a mandatory database that publishes all clinical trials and their results would provide a full picture to the medical com102 meier, negative test results, supra note 75 ("and several medical journals are con­ sidering a proposal that would require trials to be registered at the outset as a prerequisite to the results' eventual publication."). 103 hearing on antidepressant pediatric trials, supra note 87, at 8 (statement of u.s. rep. henry waxman of california) ("they are making it known to the fda because they have to, and we want to ask why [the] fda has not done more to get this information out, but there is a clear responsibility for the companies •... "). 104 john y apbe, richard edman, barry knisbkowy & joseph herman, the association between funding by commercial interests and study outcome in randomized controlled drug trials, 18 fam. prac. 565, 567 (2001) (discussing the results of their publication bias study). los /d. 78 indiana health law review [vol. 4:59 munity. 106 it would most likely be cumbersome and difficult to parse through the information if each phase of the pediatric trials were recorded in the data­ base. therefore, each phase iii trial should be registered in the database and include background information regarding the earlier phases. if, however, the drug never makes it past a phase i trial for either safety or efficacy reasons, then this information should be uploaded to the database and also indicated on the label. in this way, public disclosure of all registered clinical trials will include positive, inconclusive, and negative results. for example, this type of informa­ tion dissemination of antidepressant medication trials could have impacted the medications physicians prescribed to their patients. indeed, pediatric trials of many of the drugs believed to cause suicidal thoughts were conducted, but the results of these studies were not widely available. if the antidepressants either did not help pediatric patients or worse yet caused negative side effects, this information should be made public. under the current regulatory scheme, these studies are not required to be published. a federal registry of these test results, compiled by the fda, could alleviate this problem. opponents to the required public disclosure ofthe results of all clinical trials might argue against heightened regulatory schemes. they might argue that increased regulatory measures in one area might lead to increased regula­ tory measures in other areas. for example, the fda might begin to regulate a physician • s ability to prescribe drugs "off-label. •• this is unlikely, however, because off-label use of drugs is an accepted practice and even defined in the regulations. 107 opponents may also argue that the drug industry will set up a public regis­ try voluntarily, thus obviating the need for legislation.108 in light of the unre­ ported forest laboratories studies described earlier, a clear requirement to report pediatric trials appears necessary to address inconclusive and negative results. regulations aimed at full disclosure of clinical trials are needed to fully inform the medical community. b. changes should be made to the exclusivity provision when the bpca was first passed, debate surrounded the voluntary incen106 hearing on antidepressant pediatric trials, supra note 87, at 35 (statement ofu.s. rep. henry waxman of california) (discussing a new bill that would establish a registry of in­ formation about all the studies performed that would include positive, negative, and inconclu­ sive studies). 107 legal status of approved labeling for prescription drugs; prescribing for uses un­ approved by the food and drug administration, 37 fed. reg. 16,503, 16,503-04 (aug. 15, 1972)(to be codifiedat21 c.f.r. pt. 130);seebreslow,supranote22,at 145 (discussing off­ label practice). 108 hearing on antidepressant pediatric trials, supra note 87, at 36 (statement ofu.s. rep. henry waxman of california) (stating that congress is going to hear that drug companies are willing to set up a registry voluntarily). 2007j reforming fda policy for pediatric testing 79 tive structure for pediatric testing. proponents argued that this legislative ac­ tion, including the exclusionary provision, provides important incentives to pharmaceutical companies resulting in pediatric testing. 109 other supporters like the voluntary structure because they favor the incentive process over man­ datory pediatric testing. 110 as discussed below, to date, as long as the manufac­ turer conducts the studies and submits the results to the fda, the manufacturer receives the market exclusivity extension. that is, even if the results of the studies are negative, the manufacturer will be granted the six-month patent ex­ tension. opponents ofthe voluntary incentive structure argued that some pediatric testing should be mandatory. 111 moreover, the exclusivity provision costs con­ sumers enormous amounts of money in subsidizing the research because the cost of the trials and exclusionary period are passed along to the consumer. 112 first, a manufacturer may raise the price of a drug to pay for the clinical trials. second, consumers have access only to the one drug during the six-month ex­ clusivity period even if the results of the pediatric trial are negative. hence, the consumers pay on both ends for the clinical studies. in some situations where the manufacturer does not conduct a required pediatric trial for already ap­ proved drugs, tax money may be used to conduct the study. therefore, it costs the citizen money either as a consumer or as a taxpayer. the prea addressed the opponents' concerns to some extent, but it did not go far enough. the prea recognized the exclusivity provision in the bpca, but it changed the voluntary incentive structure. as described in part m, the fda established a list of drugs requiring pediatric testing. 113 for fda­ approved drugs, the fda gave an option to the manufacturer to test the drug. if the manufacturer did not want to test the drug, then the fda could contract with a third party to conduct the test. 114 for new drugs, the fda could require pharmaceutical companies to either conduct a pediatric clinical trial or apply for a waiver. the revision in the prea, however, did not address the cost to the consumer and taxpayer. as policy considerations, the patent extension should be conditioned on the following two criteria. first, the drug must be shown to be safe and effec­ tive in the approved pediatric trials. that is, the exclusivity provision should apply only to drugs that will be approved for use in pediatric populations. to date, if a manufacturer conducts a pediatric trial, but the drug is shown to be 109 breslow, supra note 22, at 182-83 (citing congressional records regarding the bpca). 110 id at 183 (noting proponents' positions). 111 /d. (citing congressional records regarding the bpca). 112 !d. at 183, 189 (discussing costs passed onto the consumer directly or indirectly). 113 program for pediatric studies of drugs, 42 u.s.c. § 284m(axl) (supp. iii 2003); list of drugs for which additional pediatric information may produce health benefits in the pediatric population, 63 fed. reg. 27,733, 27,734 (may 20, 1998). 114 42 u.s.c. § 284m(b)-(c). 80 indiana health law review [vol. 4:59 unsafe or ineffective, the manufacturer still receives the market exclusion. 115 opponents of this idea may argue that the high cost of clinical trials will create disincentives for manufacturers to conduct the trials without the guarantee of receiving the market exclusion. this is because the manufacturers become fa­ miliar with the six-month extension. if, however, the market extension was changed to an "icing on the cake" benefit for the required testing, then manu­ facturers would be required to conduct the trials and receive a benefit only if the drug is safe and effective in pediatric populations. thus, consumers will bear the cost only for drugs that will be used in pediatric populations and not for all drugs tested on children. for new drug applications, the six-month mar­ ket exclusion could be tacked on to the patent extension granted under the hatch-waxman act. second, the patent extension should occur only after the label changes are fully implemented.116 as described below, the average time for a label change is five months, and in some cases it occurs after one year.117 physicians need to know how to appropriately prescribe medications to pediatric populations, and the patent extension should not begin until the appropriate label changes are made. c. the new policy should address labeling changes the results of all pediatric clinical trials should follow a more rigid time frame. the antidepressant cases highlight the importance of disseminating all known information to physicians so they can prescribe the correct drug to their patients. the bpca strengthened labeling requirements, but it did not mandate proper labeling of drugs before marketing. 118 in 1979, the fda changed the labeling requirements to include a pediatric use subsection.119 under this rule, if a manufacturer completed pediatric trials and the drugs were approved for use in pediatric populations, then both the in­ dication and dose would be described under the appropriate labeling sections. if a drug had not been tested for use in children, then the label reflected that by saying either "safety and effectiveness in pediatric patients below the age of 115 hearing on antidepressant pediatric trials, supra note 87, at 17 (statement ofu.s. rep. bart stupack of michigan). 116 id. ("we have it backwards. the patent extension should only occur if the drug is safe, effective and after the necessary label changes are fully implemented. then, and only then, should a patent extension be granted."). 117 149 cong. rec. hll567, hll57l (2003) (statement ofu.s. rep. bart stupack of michigan). 118 id ("as we said earlier, the best pharmaceutical act of2002 did require a strengthen­ ing oflabeling requirements, but it did not mandate proper labeling before marketing ofthese drugs."). 119 21 c.f.r. §§ 201-202 (2002); see labson, supra note 39, at 39-41 (describing the labeling requirements). 2007] reforming fda policy for pediatric testing 81 u have not been established"120 or "safety and effectiveness in pediatric pa­ tients have not been established."121 the prea does not contain a provision addressing proper use and label­ ing prior to marketing and use in children. during the congressional hearings for the passage of the prea, representative bart stupack ofmichigan stated: so before a drug is marketed, it should be properly labeled with all the necessary information to be used in pediatric pa­ tients. doctors and patients and families have no idea on how to administer drugs or what the effect will be on young people without proper labeling. all i am saying is we should have had an opportunity to amend this legislation to make sure be­ fore a patent is extended, before a drug is given for pediatric patients, that the proper labeling is done and made available to doctors, patients, and their families. it is marketed and given to children before we know what the effects are on young people. 122 one of the main reasons for the need for pediatric testing is that physi­ cians were "dosing down" prescriptions for children based on body weight.123 but "dosing down" from a whole tablet to a half a tablet, for example, may not be the appropriate dosageor even a safe medication for a child. indeed, the reason for this is that children are still developing and may have different bio­ chemical reactions to any particular drug, whether it is a full dose or a partial dose, and "dosing down" may be ineffective or potentially harmful. a pediatric clinical trial should determine both the safety of the drug and the optimal dose and these should be reflected on the label so a physician can prescribe a drug correctly. to address this problem, a stricter time frame for safe and effective drugs should be implemented to comply with labeling requirements. moreover, if the results of a clinical trial are inconclusive or negative, the labeling changes should reflect these results immediately. for example, if a clinical trial is conducted for an antidepressant drug and the results show the drug is safe but not effective, the label should reflect this result. 124 the label 120 specific requirements on content and fonnat of labeling for human prescription drugs, 21 c.f.r. § 201.57(t)(9)(v) (2002); see labson, supra note 39, at 40. 121 21 c.p.r.§ 201.57(t)(9)(vi); see labson, supra note 39, at 40. 122 149 cong. r.ec. hl1567, hl157l (2003) (statement of u.s. rep. bart stupack of michigan). 123 groopman, supra note 1. 124 hearing on antidepressant pediatric trials, supra note 87, at 17 (statement ofu.s. rep. bart stupack of michigan) ("remember, each patent extension often means hundreds of millions of dollars to the drug companies. this systematic flaw that rewards companies for do­ ing a study, the results of which are not made public, which may show the drug is not effective and actually may harm young people and the consumers' notice, the package labeling is not inlmediately changed.") 82 indiana health law review [vol. 4:59 could say; "the results of a clinical trial show that this drug may be safe, but not effective, for use in pediatric populations." in this way, the physician is edu­ cated about the drug's potential benefits or.lack thereof. this will give phar­ maceutical companies an incentive to conduct additional clinical trials to determine effectiveness and thereby use in pediatric populations. alternatively, pharmaceutical companies may not want to conduct pediatric trials due to their high cost and the possibility of negative results. but, if the fda determines that the drug is important for use in children, then the drug company may be required to conduct the tests. d. the fda should implement additional post-approval surveillance mechanisms the fda can approve the use of a drug for children based on the results of a pediatric clinical trial, but the clinical trials may not cover all age groups or reveal long-term side effects. one of the biggest challenges in evaluating pedi­ atric populations is the biological immaturity of organs. adolescents may have very different biological reactions than toddlers. in addition, finding large sample sizes of children in a variety of age ranges makes conducting clinical trials across an eighteen-plus year age span extremely challenging. thus, post­ approval surveillance in pediatric populations will be a critical source of safety and efficacy information. the prea is a step in the right direction for follow-up studies in pediatric populations; however, it still suffers from some of the same flaws seen in the complete fda post-approval regulatory scheme. first, medwatch is a volun­ tary reporting system that allows physicians to report anecdotal information about a particular drug. 125 medw atch is a passive system for physician report­ ing, and it is unclear whether it provides the appropriate breadth of information for the fda to determine the potentially deleterious safety and efficacy prob­ lems of approved drugs. 126 second, the fda suffers from an internal structural dilemma. the center for drug evaluation and research ("cder") is the part of the agency responsible for drug approval. sitting below the coer is the office of drug safety. once the cder approves a drug, some hypothesize that tension exists, based on the hierarchy, and it may be difficult for the office of drug safety to invalidate the previous approval.127 finally, the drug companies 125 see u.s. dep't health & human servs., medwatch: the fda safety information and adverse event reporting program, form fda 3500 (oct. 2005) available at http://www.fda.gov/medwatch/safety/3500.pdf(form used to voluntarily report adverse events and product problems under the medwatch program). 126 phil b. fontanarosa, drummond rennie & catherine d. deangelis, postmarketing surveillancelack of vigilance, lack of trust, 292 j. am. med. ass'n 2647, 2647, 2649 (2004) (describing medwatch as a passive collection system); see also groopman, supra note 1, at35-6. 127 richard horton, vioxx, the implosion of merck, and aftershocks at the fda, 3641im lancet 1995, 1995 (2004) (describing the inherent flaws in the fda regulatory scheme). 2007) reforming fda poucy for pedia1ric testing 83 have little incentive to conduct and report clinical trials that would show ad­ verse drug reactions. in order to protect their economic interests, drug compa­ nies may either not conduct additional clinical trials or use subversive tactics to cover up negative information.128 the specific pediatric problems must be addressed by the fda. specifi­ cally, the fda should establish a post-approval surveillance mechanism that requires additional pediatric testing, follows anecdotal information, and uses information gathered from similar agencies in other countries. as suggested for the fda in general, an independent body should exist to regulate and monitor post-approval safety and efficacy of drugs. 129 due to the recognized niche of pediatric populations, an independent "pediatric post-approval surveillance safety and efficacy office" should be established. this new office could address many of the problems described above.130 first, it could specifically enforce post-approval clinical trials needed for addi­ tional age groups or population sizes, and congress could grant the new office the ability to bring legal sanctions against manufacturers who fail to comply with the mandatory post-approval testing.131 second, the office could evaluate whether the voluntary medwatch system is an effective means to monitor post­ approval adverse drug effects. the agency could also give the medwatch pro­ gram a "face-lift" to allow it to effectively follow anecdotal information. fi­ nally, the new office could collaborate more closely with its sister organizations in other countries. under this approach, the fda may have reacted faster to the· needed ban on ssris prescribed to pediatric populations. vi. conclusion the testing of drugs in pediatric populations runs along a regulation con­ tinuum. first, drugs that will be used in pediatric populations must be identi­ fied. second, carefully planned and ethical clinical trials must be conducted. finally, post-approval surveillance systems should monitor additional informa­ tion learned about a particular drug. the current regulatory and legislative schemes address only parts of the continuum for safe and effective drug use in pediatric populations. new policy changes must be implemented to remedy the identified deficiencies. the policy suggestions described above incorporate suggestions made by others and offer important improvements. first, the dissemination of informa­ tion through public databases will provide the medical community with impor128 fontanarosa, rennie & deangelis, supra note 126, at 2649 (noting the industry's for­ profit motivations). 129 !d. (discussing the establishment of an independent agency for drug safety). 130 id at 2649-50 (proposing the establishment of an independent agency ''to oversee postmarketing surveillance for drugs and devices" and referencing other people's suggestions for a surveillance system). 131 id (discussing post-marketing studies and legal penalties). 84 indiana health law review [vol. 4:59 tant information when prescribing drugs to their patients. it will also hold the manufacturers accountable for supplying the public with the results of their tri­ als. second, the market exclusivity provision should only apply to drugs that are shown to be safe and effective in pediatric populations. third, stricter time frames for labeling changes should occur with the results of pediatric trials to provide physicians and patients with reliable information. finally, to address the post-approval surveillance problems, congress could grant the fda the authority to establish an independent office to monitor safe and effective drug use in pediatric populations, evaluate the effectiveness of the voluntary med­ watch system, assess the current pediatric age group guidelines, and work closely to share information with sister organizations in other countries. a great many lessons are learned from evaluating the deficiencies in the fdama, bpca, and prea. due to the special nature of pediatric popula­ tions, they require heightened regulatory measures to provide them with safe and effective drugs. because the bpca and the prea will sunset in 2007, many of the regulatory deficiencies can be addressed with new legislation and regulatory schemes. patient safety or profit: what incentnes are blood shffild laws and fda regulations creating for the tissue banking industry? · jason l. williams· introduction blood shield laws have been construed to grant tissue banks immunity from strict liability. weak government oversight combined with blood shield laws create a disincentive for the organizations that recover and process tissue to focus on patient safety. the state of the industry and current food and drug administration (fda) regulations do not provide reasonable protection for recipient patients and donor families during this time of rapid expansion of the · tissue banking industry. this industry is unique because the raw material used to create the products is donated by individuals giving their final gift who probably had no idea about the for-profit nature of the industry and the risks involved. patient safety should be the primary concern because of the particularly dangerous nature of donated human tissue. therefore, if the courts were to apply the reasonable alternative standard of strict liability, society's expectation of tissue banking could be achieved by forcing the industry to internalize the harm caused by unreasonable practices and create an economic incentive for tissue banks to implement processes that are in the interest of patient safety and donation in general. this note will observe the current state of the tissue banking industry and the possible adverse effects this structure could have on patient safety. to illustrate the disincentives created by the blood shield laws, this note will present an overview of the impact of the blood shield laws on hemophiliacs in the nineteen-eighties and compare the plasma fractionation industry with the tissue banking industry. finally, this note will propose that the blood shield laws be amended to subject tissue banks to strict liability. parts i and n of this note discuss the history and current state of the tissue banking industry along with fda regulation. parts ill and n provide an overview of blood shield laws and discuss cases analyzing the rationale applied to blood shield laws. part v discusses two recent cases immunizing tissue banks from strict liability. parts vi and vll describe how blood shield laws coupled with poor regulation failed to create incentives for the plasma fractionation industry to effectively consider patient safety. parts vm and ix discuss the risks associated with· the tissue banking industry and how the * j.d. candidate, 2005, indiana university school of law-indianapolis; b.s., 1999, murray state university, murray, kentucky. the author wishes to thank shelley s. fraser for her helpful comments. 296 indiana health law r.bview [vol. 2:295 imposition of strict liability could avert a medical disaster similar to the one suffered by hemophiliacs. i. the dssue banking industry a. ·a brief history of the tissue banking industry to properly understand the tissue banking industry today, it is important to understand how the banking industry developed. the first tissue bank was established in the nineteen-forties by the united states navy.1 this bank only recovered and stored bone, skin, dura, fiiscia, and tendons.2 traditionally, the majority of tissue were located in hospitals and only served the local community.3 these banks were created by physicians, researchers, or hosp­ itals to meet their own.demand for tissue.4 in 1987, the tissue banking industry was described as a "cottage industry."5 at that time, most tissue banks were still very small, only banking, at most, a few tissues, and serving the physi­ cians who established the bank. 6 in the late eighties most of the large tissue banks were based out of major medical institutions that had transplantation programs that created demand for banked tissue. 7 even though the tissue banking industry, at that time, was not-for-profit, it was recognized that it would be problematic if private companies became involved in tissue banking and processing. 8 the traditional community tissue banks were comparable to blood banks. blood banks are typically run by hospitals, the american red cross, or local non-profit organizations to serve the needs of a particular community. iri the initial stages of development, tissue banks could be compared to blood banks in their .structure and motivation; they were not-for-profit organizations motivated only to provide the tissue necessary to meet their particular demand. in 1987, the executive director of the largest freestanding tissue bank, virginia based lifenet, a not-for-profit tissue bank still in existence today, stated, "[w ]e don't try to make the largest number of deposits, we try to take what is needed.',g this statement indicates the respect for the gift and the motivation 1. timothy f. kim, tissue banlcing in midst oj'revolution of expansion' as more uses are found for various transplants, 258 jama 302, 303 (1987). 2. id. 3. id. at 302. 4. id 5./d 6. timothy f. kim, how does tissue banking work? virginiabqllk, while not typical, may offer some insights, 258 jama304 (1987). 7. kim, supra note 1, at 302-03. 8. id. at 304. the introduction of for-profit organizations into an area where altruism shoulddominatecouldeasilyperverttheentiredonationprocess. profiteeringcouldoverwhelm altruism and create a serious disincentive for individuals to choose to donate. 9. kim, supra note 6, at 304. 2005] blood shield laws and fda regulations 297 behind this organization-to take what is really needed. due to the state of the tissue banking industry at the time the blood shield laws were enacted, itis not difficult to see why courts and legislatures were willing to bring tissue banks behind the statutory shield. 10 b. accreditation the american association of tissue banks (aa tb) is the only organization that accredits tissue banks in the united states. the aatb was created in 1976 to ensure quality standards, encourage donation, create a forum for scientific exchange, promote ethical standards throughout the industry, and ensure an adequate supply of transplantable human tissue. 11 it publishes standards and only offers accreditation to organizations that meet its standards.12 however, accreditation is not required for a tissue bank to legally operate. 10. traditionally, blood banks have been commmrity centered specializing in a very narrow area-the collection and distribution of blood. however, there are two different types of blood collection activities. comm. to study hiv transmission through blood & blood products, inst. of med., hiv and me blood supply: an analysis of crisis decision making 25 (lauren b. leveton et al. eds., 1995) [hereinafter hiv and tile blood supply]. first, whole blood is collected by several blood collection organizations throughout the united states. these organizations include the american red cross, commmrity blood banks, and hospital blood banks. id at 26-28. the components collected from whole blood are red blood cells, platelet concen1rate, and fresh frozen plasma. id at 27. the second blood collection activity is conducted by the for-profitplasma fractionation industry for collection and supply, manufucturing, and research. ld. at 26. these for-profit plasma collection organizations collect plasma through a process called plasmapheresis, which only exttacts plasma from the donor, and purchase plasma collected by the banks that collect whole blood. id at 29-31. plasma donors who donate through the organizations supported by the blood fractionation industry are compensated for their plasma. id at 31. however, whole blood donors are not compensated for their donation. id. due to the high demand for plasma and the uncomfortable and time consuming process of plasmapl;leresis, compensation for donors was legalized and many plasma collection centers up to the early nineteen-eighties were located in areas such as prisons with high infection rates ofhepatitis. id at 30. whole blood collection organizations most likely fit the public's perception ofblood collection organizations. these organizations are only in existence to serve a vital function in the health care system-to maintain an adequate and safe supply ofblood. these organizations do not exist to make a profit most likely, many whole blood donors would be opposed to donation if they knew their altruistic gift was used to generate a profit in turn, blood shield laws protect these whole blood collection organizations from liability that could frustrate their purpose and severely lijnit the supply of a vital health care resource. however, plasma collection organizations cannot be easily placed in the same category as whole blood collection organizations. these organizations are controlled by the for­ profit plasma fractionation industry. additionally, plasma donors are most likely motivated by compensation. the motivation behind the two types of collection organizations is crucial when considering the impact ofblood shield laws on each organization's decision making process. 11. aatb, about ·the american association of tissue banks, at http://www.aatb.org/aatbintr.htm (last visited apr. 19, 2005) (on file with the indiana health law review). 12. id. 298 indiana health law review [vol. 2:295 in january 2001, the department ofhealth and human services (hhs), office of inspector general (oig) found that the aatb accredited fifty-eight tissue banks but identified ninety banks that were not accredited. 13 at that time, the unaccredited tissue banks ranged from the very small to very large, including the largest processor of heart valves.14 in its report, the oig stated that there were no incentives for tissue banks to seek accreditation.15 some of the factors that discourage accreditation indicated in the report were the following: ( 1) hospitals and physicians regularly purchasing products from non-accredited banks; (2) accreditation can be cost prohibitive to some smaller banks; and (3) requiring inspection by a third entity may seem unduly burdensome to banks that are already subject to inspection by the fda and the state in which they are located. 16 accreditation by the aa tb is not the standard throughout the. industry. historically, numerous tissue banks have not sought accreditation. in 1987, only three tissue banks were accredited out of over 400 banks in operation at that time. 17 c. the tissue banking industry today the tissue banking industry has undergone a revolution in the past decade. first, the tissue banking industry has grown rapidly. for example, 350,000 human tissue products were transplanted in 1990; however, more than 800,000 tissue products were transplanted in 2002.18 second, many of the traditional coilllllunity tissue banks no longer process tissue. instead, most of the community banks send the tissue that they recover to for-profit tissue processors and collect a recovery fee. 19 the for-profit processing companies generate substantial revenue from "selling" the tissue processing service to hospitals and physicians who.transplant.the tissues.20 over the past several 13. dep'tofhealth&humanservs.,off'iceofinspectorgen.,oei-01-00-00441, oversight of nssue banking 9 (2001). 14. ld 15. /d. 16. id 17. kim, supra note 1, at 303. 18. tissue banks: the dangers oftaintedtissuea and the need for federal regulation: hearings before the comm. on gov't affairs, 108th cong. (2003) [hereinafter dangers of tainted tissues hearings] (statement of jesse l. goodman, director of the fda center for biologics evaluation and research). 19. see dep't of health & human servs., office of inspector gen., oei-01-0000440, informed consent in 'fissue donation:. expectation and realities (2001) [hereinafter consent in tissue donation]; see also john j. zodrow, the commodification of human body parts: regulating the tissue bank industry, 32 sw. u. l. rev. 407,408-09 (2003). 20 •. sandra blakeslee, lack of oversight in tissue donation &ising concerns, n.y. times, jan. 20, 2002, § 1 (national desk), at 1. ctyolife is the leader in processing heart valves but also produces several different tissue products. ~ts net revenues were $87.7 million in 2001, $77.8millionin2002,and$59.5millionin2003. cryolife,inc.,2003annualreportf-30 (2004), http://www.cryolife.comfmvestornew.b1m (last visited apr. 19, 2005) (on file with the 2005] blood shield laws and fda reaulations 299 years, the large for-profit tissue processing companies have entered into partnerships with community tissue banks to increase the processing companies' access to tissues these banks recover. 21 these partnerships allow the tissue processing organizations reliable access to the raw materials they need to generate revenues.22 however, these partnerships indicate the entire industry is shifting from a charitable institution into a business institution motivated by profits rather than pwpose. 23 this trend is likely to increase given the current state of the pharma­ ceutical industry shifting some of its focus toward the use of human tissue for research and possibly production of the next significant pharmaceutical breakindiana health law review). lifeceu. another tissue processing company, reported net revenues of$26.6 million in 2001, $32.9 million in 2002, and $38.6 million in 2003. lifeceu. corp., 2003 annual report (2004), http:/lwww.lifecell.com/downloads/annual/2003% 20annual%20repoftl'ai20with%201 0-k.pdf(lastvisitedapr. 19, 2005) (on file with the indiana health law review). osteotech, a tissue processing company focusing on bone and connective tissue, generated over $94 million in net revenues in 2003, over $83 million in net revenues in 2002, and over $75 million in net revenues in 2001. osteotech, inc., financial: financial highlights, at http://www.osteotech.com/fiohi.htm. (last visited apr. 19, 2005) (on file with the indiana health law review). regeneration technoiogies, a tissue processing company founded in 1998, reported net revenues of$69 million in 2002, $75.5 million in 2003, and $92.7 million in 2004. regeneration technologies, inc., investors: financial highlights, at http://www.rtix.com/investors/financial.cfi:n(lastvisitedapr.19,2005)(onfilewiththelndiarul health law review). in 2003, it is estimated that industry revenues would have reached the $1 billion mark. blakeslee, supra note 20, at l. 21. see blakeslee, supra note 20, at 1; stephen j. hedges, cadavers for cash in texas: 'people make a lot of money selling tissue', chi. trjb., may22, 2000, at 10; ronald campbell et at., anatomy of an ipo: making charity pay investigations: a flurry of deals builds regeneration technologies into a tissue-industry giant, orange couni'y reo. may 7, 2000, at ai. 22. see supra note 21. 23. the changes in the industry are dramatic indicating areal shift in the motivation from altruism to profit the chicago tribune reported that in 1999 a county in texas took bids from area tissue banks for the right to take tissues from bodies collected by the medical examiner. this contract went for $180,000 annually. hedges, supra note 21, at 10. this contract may appear significant, but it has been estimated that a human body is worth as much as $220,000. blakeslee, supra note 20, at 1. one interesting example of the shift from non-profit to for-profit is regeneration technologies, inc. (rti). rti was a spin off of the university of florida tissue bank and derives all its revenues from processing human tissues. campbell et al.; supra note 21, at al. a top official at both rti and the university offlorida tissue bank minimized concerns about profiting from donated tissue by stating, "[w]e're not talking about people profiteering or exploitation ... [w]e're talking about something that is very accepted in our business system in this country-that there is a return on investment." id rti states that it processes about one-third of all tissue donated in the united states. id rti has also created strong partnerships throughout the industry by contracting for exclusive rights to donated tissue, buying or providing management services to tissue banks, and controlling non-profit groups within the industry. id. additionally, the not-for-profit tissue bank, from which rti was created, was the largest shareholder in rti at that time. id another disturbing fact is that several states permit funeral homes to contract with tissue banks allowing tissue recovery technicians to harvest the tissue at the funeral home. blakeslee, supra note 20, at i. the actions of the industry appear to be turning a precious gift into a common commodity. see zodrow, supra note 19, at 409. 300 indiana health law review [vol. 2:295 through.24 the tissue banking industry is driven by biotechnology innovation. the innovators in this industry patent their techniques for processing donated human tissue and aggressively market their products to hospitals. 25 this trend is not likely to change given the substantial revenues generated by selling processed human tissue. clearly, the tissue banking industry today has drastically changed. in the past, the industry resembled the blood banking industry serving the community motivated by an altruistic desire to bring a desperately needed resource to the community. this motivation does not appear to hold true for at least some organizations within the tissue banking industry today.26 the appearance of for-profit companies in the industry casts a suspicious shadow on the motivations of the organizations and is not compatible with many of the assumptions families have when they consent to donation. 27 the only possible motivation for a private, for-profit company is profit. clearly, there is money to be made in the tissue banking industry. most likely, the incentives to generate revenue and profits from processing donated human tissue were not considered by the legislatures when enacting the blood shield laws; however, the motivations and disincentives created by the current regulations and blood shield laws must be considered in light of the industry today. 24. see james boxell, uk: u.s. deal boosts drug company, fin. times, dec. 29, 2003, at 18; finance; human tissue research bank closes financing round, medical devices & surgical tech. wk., dec. 21, 2003, at 57; genomics collaborative inc.: pact is signed with novartis to supply samples of material, wall. st. j., sept. 22, 2003, at cl3. 25. blakeslee, supra note 20, at 1. 26. during a senate hearing, the questionable practices of one tissue bank operating in the washington, d.c. area were highlighted by williams minogue, m.d. he stated that after the local organ procurement organization had ruled out a deceased individual for organ and tissue donation for transplantation purposes due to medical unsuitability, a second tissue bank obtained confidential patient information and approached the family to obtain consent for tissue donation. the family had specifically stated that they did not wish to donate for medical research, the only realistic donation option for the patient the second tissue bank stated that they were pursing the tissue for transplant even though the patient was out of the standard age range, bad a history of cancer, showed evidence of a recent infection, and was dead for almost twenty-four hours (to ensure safety the maximum time between death and recovery of transplant tissue is twenty-four hours) when the second tissue bank contacted the family. the only plausible explanation for the second tissue bank's action was that it was attempting to recover the tissue for research but not disclosing this information to the family. the second tissue bank was recovering tissue for a for-profit tissue bank. these actions illustrate that some tissue banks allow profit motives to supercede the public's interest in donation. human tissue banks: hearings before thesubcomm. on investigations ofthecomm. on governmental affairs, 106th cong. (2001) [hereinafter human tissue banks hearings] (statement of william minogue, m.d., chairman, bbard of directors, washington regional transplant consortium). 27. consent in nssue donation, supra note 19, at ii (stating that in reality, contrary to most families• assumptions, tissue banking is commercialized, donated human tissue is viewed as a commodity after it is processed, and some donated tissue, particularly skin, is used for cosmetic purposes). 2005] blood shield laws and fda regulations 301 ll. fda regulation of the dssue banking industry current fda regulations apply to any organization that recovers, screens, tests, processes, stores, or distributes human tissue. 28 however, the regulations that apply to drugs and medical devices do not apply to tissue banks, most importantly the requirement for pre-market approval.29 tissue banks are required to determine donor suitability by testing for certain infec­ tious diseases, calculating hemodilution, and reviewing donor medical records. 30 records containing information on the donated tissue must be kept up-to-date during every significant step of the donation process, and tissue must be properly quarantined until suitability for donation is determined.31 additionally, tissue banks are required to retain records of every recovered tissue for at least ten years beyond the date of transplantation or other disposi­ tion. 32 they are also required to have written procedures in place to ensure compliance with regulations and prevent the spread of infectious disease and cross-contamination during processing. 33 the records tissue banks keep must include the results of all tests, the identity and medical records of the donor, and information regarding the chain of custody or destruction of the donated tissue. 34 all tissue banks are required to allow fda inspections of their facility.35 the fda also has retained complete power over tissue imported from foreign countries. 36 if the fda finds a tissue bank in violation of any of the regulations, it may retain, recall, or destroy questionable tissue.37 the fda also requires tissue banks to register with the center for biological evaluation and research.38 this is the extent of current fda regulation of tissue banks. tissue products are exempt from the more stringent requirements on drugs and medical devices if they meet the following criteria: (1) the product is minimally manipulated; (2) the product is intended for a homologous use;39 (3) the processor does not combine "another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent," with the tissue; and (4) the product does not have a systemic effect and is not dependent upon 28. 21 c.f.r. § 1270.1 (2005). 29. jd. 30. 21 c.f.r. § 1270.21 (2005). 31. 21 c;f.r. § 1270.33 (2005). 32. jd. 33. 21 c.f.r. § 1270.31 (2005). 34. 21 c.f.r. § 1270.35 (2005). 35. 21 c.f.r. § 1270.41 (2005). 36. 21 c.f.r. § 1270.42 (2005). 37. 21 c.f.r. § 1270.43 (2005). 38. 21 c.f.r. § 1271.1 (2005). 39. "homologous use means the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an hct/p [human cells, tissues, or cellular or tissue-based product] that performs the same basic function or functions in the recipient as in the donor.'' 21 c.f.r § 1271.3(c) (2005). 302 indiana health law review [vol. 2:295 metabolic activity of living cells for its primary function.40 however, the product may escape this last condition if certain criteria are met.41 if a tissue product does not meet these specific requirements, the fda requires that it be regulated as a drug or medical device;42 however, it should be noted that most tissue products are not regulated as drugs or medical devices. therefore, in most cases involving tissue products, the fda's authority is limited to the prevention of communicable diseases.43 the regulations indicate the fda is relying on the established tissue banking industry to police itself. the fda actually rewrote language. in the regulations practically allowing the industry to decide whether a product should be regulated as a drug or medical device.44 in its revision the fda stated,"[ w ]e agree that the establishment that manufactures the hct/p [human cell, tissue, and cellular-tissue based product] should make the initial deter­ mination of whether the addition of a drug or device that is a sterilizing, pre40. 21 c.f.r. § 1271.10 (2005). 41. id. § 1271.10(ax4)(iixa-c) (allowing systemic effect or dependence on metabolic activity if tissue used for autologous use, a first or second-degree relative, or reproductive use). 42. 21 c.f.r. § 1271.20 (2005). 43. see human cells, tissues, and cellular and tissue-based products; establishment, registration and listing, 66 fed. reg. 5447, 5449 (jan. 19, 2001 ); see also current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement, 69 fed. reg. 68,612, 68,613 (nov. 24, 2004)(to be codified at 21 c.f.r. pts. 16, 1270, 1271). unless a hct/p is categorized as a drug or medical device, the fda only has the authority to regulate the product under section 361 of the public health service act. 42 u.s.c. § 264 (2005). this limits the fda's authority to prevent communicable diseases. as a result of this limited authority, no pre-market approval is required by the fda. human cells, tissues, and cellular and tissue-based products; establishment, registration and listing, 66 fed. reg. at 5449. lfthe hct/p is classified as a drug or medical device, the fda has the authority under section 352 of the public health service act to impose more comprehensive regulations, including pre-market approval. 42 u.s.c. § 262 (2005). 44. in response to the concerns expressed by these comments, we have rewritten the proposed language. proposed§ 127l.io(c) has been renumbered as§ 1271.10(ax3), and now reads: ''the manufacture of the hct/p does not involve the combination of the cell or tissue component with a drug or a device, except for a sterilizing. preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the hct/p." the addition of a drug or a device to the cell or tissue component of an hct/p may ordinarily be expected to add a therapeutic effect and may also raise safety concerns. for these reasons, the addition of a drug or a device to a cell or tissue makes it no longer appropriate to regulate the hct/p solely under section 361 of the phs act. (as used, the terms drug and device are defined in section 201(g) of the act (21 u.s. c. 321(g)). however, we recognize that the use of certain sterilizing, preserving, and storage agents do not raise the same concerns. for this reason, we have excepted sterilizing, preserving, and storage agents, but only if the addition of the agent does not raise new clinical safety concerns with respect to the hct/p. examples of substances that would generally be acceptable include: (1) cryoprotectants (e.g., dmso); (2) chemicals used for sterilization (e.g., ethylene oxide); and (3) storage solutions. we encourage the development of industry standards that describe the safe use of sterilization, preserving, and storage agents. human cells, tissues, and cellular and tissue-based products; establishment registration and listing, 66 fed. reg. at 5459 (emphasis added). 2005] blood shield laws and fda regulations 303 serving, or storage agent to an hct ip raises new clinical safety concerns. '"'5 the fda's stance gives the tissue banking industry free reign to determine what is in the best interest of patient safety without any check on the decision­ making process employed by a company who stands to profit from an innovative processing technique that most likely required substantial investn;tent to develop. clearly, there is an incentive for a tis8ue proeessing company to determine the addition of an agent does not present a new <safety concern thereby requiring time consuming and costly fda pre-lnarket approval. the fda has established regulations that set manufacturing standards for the tissue banking industry.46 these regulations require tissue manufac­ tures ·~ follow current good tissue practice (cgtp), which governs the methods used in, and the facilities and controls used for, the manufacture of hct/ps; recordkeeping; and the establishment of a quality program.'"'7 in­ terestingly, the proposed regulations--the foundation of the current regulations -were based entirely on the current practices of the industry.48 if. a tissue product is not classified as a drug or medical device, the proposed rule does not require pre-market approval for any processing techni­ que. it only requires that the manufacturers not pool49 human tissue during the manufacturing process and that they validate the process to ensure that it "does not cause contamination or cross-contamination" and "prevents the introduc­ tion, transmission, or spread of communicable disease.'.so however, the pro­ cess validation is carried out by the manufacturer. 51 although these regula­ tions give the fda increased oversight of tissue processing, the fda still relies on the industry to police itself. the fda provides no incentive to develop new technology in order to prevent risks that are considered accept4s.ld 46. current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement, 69 fed. reg. at 68,612. 47. ld 48. jd. at 68,615 (stating "[t]he proposed requirements were based on current good industry practice"). . 49. pooling refers to placing tissue or human cells from two or more donors in contact with on another or mixing them in a single receptacle during manufacturing. current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement, 69 fed. reg. at 68,632. pooling of human tissue during processing is thought to be an unacceptable practice and may pose a risk to patient safety. see letter from theodore malinin, m.d., professor of orthopaedics and rehabilitation and director, tissue bank; university of miami school of medicine, to dockets management branch. docket no. 97b-484p, food & drug administration (may 7, 2001), http://www.fda.gov/ohrmsldockets/dailys/ol/mayol/050801/97n_ 484p-c000019.pdf (last visited apr. 19, 2005) (on file with the indiana health law review). 50. current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement, 69 fed. reg. at 68,684 (to be codified at 21 c.p.r.§ 1271.220). 51. jd at 68,684, 68,660 (to be codified at 21 c.p.r.§ 1271.230). 304 indiana health law review [vol. 2:295 able within the industry. these acceptable risks could end up being highly detrimental to patient safety. ill. blood shield laws forty-eight states have enacted statutes that grant blood banks immunity from strict liability. 52 some states explicitly grant immunity to blood banks in order to shield the industry from strict liability. 53 many states characterize a blood related transaction as the rendering of a service as opposed to the sale of a good; therefore, a plaintiff cannot pursue an action in strict liability. 54 due to blood shield laws, the blood banking industry enjoys a comfort that most manufacturers do not enjoy in american society, which is immunity from strict liability. the treatment of the blood banking industry is the exception to the rule of product liability. as discussed infra part v.a.-b., courts and legisla­ tures appear to be willing to place tissue banks in the same category. n. blood shield law rationale anal vzed by courts although few courts have addressed whether tissue banks should be granted immunity from strict liability, several courts have determined whether pharmaceutical companies producing blood clotting factors from blood plasma should be granted immunity from strict liability. these courts faced the situa­ tion of determining whether hemophiliacs who contracted hn through blood clotting factors could bring a strict liability claim. due to the latency period between infection and the manifestation of symptoms of hn and the immunity granted to the plasma fractionation industry, the plaintiffs in these cases found it almost impossible to receive compensation for their injuries. ss however, a plaintiff's only effective means of redress for her injury was a claim in strict liability. the majority of american courts refused to allow these plaintiffs to bring a claim in strict liability, thereby denying any means of relief for the pain and suffering caused by diseases contracted through the use of products manufactured and sold by several for-profit pharmaceutical companies. 52. americanlawofproductsliabwty('fh:ird) § 20:3 (2004). 53. see, eg., ark.. code ann.§ 20-9-802 (michie 2005); 42 pa. cons. stat.§ 8333 (2004); wyo. stat. ann.§ 35-5-110 (michie 2004). 54. see, eg., ala. code § 7-2-314(4) (2005); alaska stat. § 45.02.316(e) (michie 2004);ariz:rev.stat. § 36-1151 (2004);cal.health&safetycode § 1606(west2005); fla. stat. ann.§ 672.316(6) (west 2004); la. rev. stat. ann.§ 9:2797(a) (west 2004); n.y. pub. health law§ 580(4) (mckinney 2005); wash. rev. code§ 70.54.120 (2004). 55. see hiv and the blood supply, supra note 10, at 223-24; george w. conk, is there a design defect in the restatement (third) of torts: products liability?, 109 yale l.j. 1087' llll-17 (2000). 2005] blood shield laws and fda regulations 305 a. immunity granted to commercial entities under blood shield laws the vast majority of courts throughout the united states have been unwilling to impose strict liability on pharmaceutical companies by construing the statutes broadly, allowing commercial entities immunity under blood shield laws. a california appellate court stated public policy supported immunity because it was impossible to test for hepatitis or screen donors to completely remove the risk of infection. 56 while making a reference to penicillin and cortisone, the court determined that blood clotting factors were unavoidably dangerous and that a court should be hesitant to impose strict liability because it could deter pharmaceutical companies from producing and selling enor­ mously beneficial medical products. 57 the rationale given in fogo is typical of courts in late nineteen-seventies and early nineteen-eighties when faced with a case involving a hemophiliac who was infected with a blood borne disease by clotting factors. many courts believed the risk of hepatitis and hn infection was an unavoidable risk associated with the use of blood clotting factors. however, blood clotting factors were dangerous to anyone exposed to an infected product. the result­ ing infection was more than a potential side effect, it was an inevitable result. 58 the spread of a communicable disease is hardly analogous to the potential side effects of a drug; however, courts used this rationale to support immunity for pharmaceutical companies producing blood-clotting factors. 56. fogov. cutterlab.,inc.,137cal.rptr.417,422(cal.ct.app.l977). although this statement had some merit at that time, the process used to create clotting factors greatly increased the chances hemophiliacs would contract a blood borne disease such as hepatitis or hiv. seelllv andthebloodsupply,supranote 10, at 81. 57. fogo, 137 cal. rptr. at 422. the court quoted prosser to support its unavoidably unsafe determination: there are a number of cases involving hepatitis resulting from blood transfusions. so far as the transfusion itself is concerned, it has been regarded by most courts as a service, and not a sale, so that in the absence of negligence there is no liability of the hospital which gives it. but a blood bank which supplies the blood is certainly to be regarded as a seller; and [t]he general refusal to hold it strictly liable has gone on the basis of the unavoidability of the danger . . . . but strict liability, whether on warranty or in tort, does not require negligence; and the question becomes one of whether the defendant is to be held liable for marketing the thing at all. the argument that industries producing potentially dangerous products should make good the harm, distribute it by liability insurance, and add the cost to the price of the product, encounters reason for pause, when we consider that two of the greatest medical boons to the human race, penicillin and cortisone, both have their dangerous side effects, and that drug companies might well have been deterred from producing and selling them. wiwam prosser, law of torts unsafe products, § 19 at 661-62 (4th ed. 1971 ). 58. in 1987, the centers for disease control and prevention (cdc) reported that approximately seventy percent ofhemophilia a patients and thirty-five percent ofhemophilia b patients had tested positive for hiv antibodies. human immunodeficiency virus infection in the united states, 36 morbidity & mortalitywkly. rep. 801 (1987). 306 indiana health law review [vol. 2:295 when a hemophiliac was infected with hn after he received tainted clotting factors, a georgia district court determined that allowing an action in strict liability would defeat the purpose of the blood shield law. 59 in another case involving a hemophiliac who contracted aids from clotting factors, an illinois district court based its decision on the legislative determination that the blood shield laws were important to the health and welfare of the people of illinois because strict liability would inhibit the "exercise of sound medical judgment and restrict the availability of important scientific knowledge, skills and materials .• .ro the court determined that the plaintiff's interest in a remedy for her injury was outweighed by society's interest in maintaining an adequate blood supply.61 finally, the court found that it was immaterial that the pro­ ducers of the clotting factors were commercial producers because the blood shield laws were drafted broadly to include any entity engaged in the pro­ duction and distribution of blood products.62 along these same lines, a pennsylvania court ruled, as a matter of first impression, that the pennsylvania blood shield laws were applicable to commercial entities after a patient con­ tracted hepatitis b and c from contaminated platelets; it specifically declared that public-policy was not against allowing immunity for commercial industries. 63 the court reasoned that there may never realistically be a test that can completely eliminate the risk of viral infections from blood clotting factors; therefore, the imposition of strict liability on commercial producers of blood clotting factors would discourage blood banking and frustrate the purpose behind the blood shield law.64 continuing the trend, a minnesota district court adopted the view that clotting factor producers were unable to completely remove the risk of hn infection from clotting factors even by exercising due care. 65 interestingly, the court determined the clotting factors lengthened and improved the quality of hemophiliacs' lives66 while minimizing the plaintiff's statement that approxi­ mately seventy-five percent of hemophilia a patients, who represent nearly half the patient population for clotting factors, were infected with hn in 1982.67 the court rationalized its decision on the policy ground that imposing strict liability on such a small market would dramatically increase the cost of the product and threaten its availability.68 59. jones v. miles lab., inc., 705 f. supp. 561,563 (n.d. ga. 1987). 60. poole v. alpha therapeirtic corp., 698 f. supp. 1367, 1370 n.3 (n.d. ill. 1988). 61. id. thecourtbuttresseditspositionbynotingthatimmunitywasacceptedthroughout the nation. id 62. id. 63. weishom v. miles-cutter, 721 a.2d 811, 814 (pa. super. ct. 1998). 64. id 65. doe v. travenol lab., inc., 698 f. supp. 780, 784 (d. minn. 1988). 66. id. 67. /d. at 784 n.8. 68. id at 784. 2005] blood shield laws and fda regulations 307 although the arguments in favor of immunity are persuasive in light of society's interest in maintaining an adequate blood supply, the courts failed to address whether the pharmaceutical companies could have taken steps to reduce the risk of infection. every court focused on the fact that the risk 'of hiv and hepatitis could not be completely prevented and ended their .analysis of the risk at that point. however, if the courts had been willing to investigate the industry more closely, they may have been more inclined to construe the blood shield laws narrowly and allow relief. b. immunity not applicable to commercial entities under blood shield laws some courts have been unwilling to construe the blood shield laws broadly, thereby denying for-profit pharmaceutical companies immunity under blood shield laws. the indiana court of appeals refused to grant immunity to pharmaceutical companies that supplied tainted clotting factors to a patient who eventually died of aids.69 adopting the principle of strict construction in this situation, the court determined that the legislature would have explicitly included pharmaceutical companies in the statute if it had intended to grant commercial entities immunity.70 the court concluded that commercial pro­ ducers of clotting factors were not in the same class as blood banks even though the manufacturing of factors involved storage ofblood.71 in tum, the court held that the pharmaceutical company's activities constituted the sale of a good rather than the rendition of a service; therefore, the company was subject to strict liability. 72 a district court in maryland refused to grant immunity from strict liability narrowly construing maryland's blood shield statute. ·the court also determined that the risk of hiv infection from clotting factors was not a reasonable danger.73 the court addressed numerous public policy grounds supporting immunity but ultimately determined that blood containing an undetectable disease was a defective product.74 the defendant argued that allowing a claim in strict liability could dramatically decrease the supply of clotting factors. 75 the court dismissed this plea stating that the arguments in favor of strict liability apply to clotting factors just as they do to all other 69. jkb v. armour pharm. co., 660 n.e.2d 602 (ind. ct. app. 1996). 70. jd at 605. 71. ld. 72. id. 73. doe v. miles lab., inc., cutter lab. div., 675 f. supp. 1466, 1479 (d. md. 1987). the court commented on the alarmingly high rate of infection: "it is estimated that up to 95% of severe hemophiliacs test positive for exposure to the htl v -lll virus. the nearly complete exposure by the group most in need of coagulant-factors and the inevitably fatal nature of the disease for those who actually develop it are stark facts." id (citation omitted). 74. id 75. jd. at 1479-80. 308 indiana health law review [vol. 2:295 products: first, the court could not find a good reason to shift costs of the injury from the manufacture to the victims; second, the court recognized that it was a rational business decision to keep costs down and strict liability is the incentive for businesses to prevent accidents; third, the manufacturers of products are in the best position to spread the costs of injury; fourth, the court believed it wa8 a better allocation of resources for the price of blood to reflect its actual costs. 76 finally, the court stated it did not have the authority to create a subsidy for a particular product by shifting the costs of accidents to the consumer or the state without a clear expression by the legislature.77 the washington supreme court stated that the legislature, when enacting blood shield laws, did not intend to grant statutory immunity from strict liability to pharmaceutical companies producing blood clotting factors. 78 the court focused its attention on the fact the legislature only considered whole blood when enacting the blood shield law, an abrogation of the common law.79 again, a court, operating under strict construction, refused to construe the statute broadly enough to allow immunity for commercial manufactures. all of the courts which refused to grant statutory immunity faced statutes similar to the one in condos. 80 however, they chose to construe the statutes very narrowly realizing the implications of their decisions. these courts were willing to recognize the differences between blood banks and commercial producers and impose strict liability on entities primarily motivated by profit, not patient safety or purpose. c. restatement's rationale for limiting strict liability to blood banks courts in the past have relied on the restatement (second) of torts81 position, placing blood products in the same class as prescription drugs and vaccines and labeling them as unavoidably unsafe. the position taken by the restatement (second) of torts is that some products cannot be made safe given the current state of human knowledge.82 as an example, the restate­ ment acknowledges that many drugs and vaccines may cause serious side effects, however, these side effects are justified because the disease itself can lead to death. 83 these unsafe products are not considered unreasonably dan76. ld. at 1480. 77. id 78. rogers v. miles lab., inc., 802 p.2d 1346, 1347 (wash. 1991) (stating that blood clotting factors are unavoidably unsafe and manufacturers should not be held strictly liable if proper warnings were included). 79. id. at 1349. 80. condosv. musculoskeletal transplant found., 208 f. supp. 2d 1226 (d. utah 2002). in condos, the court ordered a strict liability claim against a tissue bank dismissed even though the blood shield law did not explicitly grant immunity to tissue banks. id see infra part v .a 81. restatembnt(sbcond)oftorts § 402a cmt. k (1965). 82. id 83. ld 2005] blood shibw laws and fda regulations 309 gerous if properly produced and accompanied by appropriate warnings. 84· this comment also states that experimental drugs should not be considered unrea­ sonably dangerous "because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk.'.ss the restatement's position is clear that strict liability should not be applied to drugs and vaccines. the consequences are considered "unfortunate" but reasonable because these products are considered useful and desirable. 86 the restatement (second) takes the position that a product that cannot be made safe is not unreasonably dangerous under a products liability standard if the product is useful and desirable and proper warnings are given. in a more recent publication, the american law institute (ali)87 has expressed a slightly different rationale for the unique treatment of drugs and medical devices. the restatement (third) of torts: products liability states that a product is not reasonably safe if the risks of the product known to medical professionals would significantly outweigh the benefits, thereby preventing the health care provider from using the product on any class of patient. 88 the ali places drugs and medical devices in a unique category outside of standard consumer products. 89 this distinction is rightful. it recog­ nizes that drugs and medical devices are very unique in that they may be harm­ ful to one patient but lifesaving to another; therefore, drugs and medical devices should be employed only under a physician's care who can thought­ fully weigh the risks and benefits to each particular patient 90 implicit in the physician's and patient's consideration of the risks and benefits is full disclosure of the known risks and benefits of the drug or medical device. the ali states that courts have given considerable deference to regulatory agencies when considering drug design.91 this deference rests on three assumptions: first, it is in the interest of public policy for drugs and medical devices to be available to patients at a reasonable cost; second, when health care providers are informed about the drugs and medical devices by the manufacturers, the proper drug or medical device will be prescribed to the patients who can truly /d. 84. id. 85. id. 86. id. 87. the ali publishes the restatement 88. restatement (third) of torts: products liabb.jty § 6(c) (1998). a prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficientlygreatinrelationtoitsforeseeabletherapeuticbenefitstbatreasonable health-care providers, knowing ofsuchforeseeablerisksand therapeutic benefits, would not prescribe the drug or medical device for any class of patients. 89. id. § 6 cmt. b. 90. id. 91. id. 310 indiana heallh law review [vol. 2:295 benefit from the drug or medical device; third, "governmental regulatory agencies .adequately review new prescription drugs and devices, keeping unreasonably dangerous designs off the market.•>!n th~ ali then goes to state its rationale for the relaxed standard for drugs and medical devices: the requirement for establishing defective design of a pre­ scription drug or medical device ... is that the drug or device ' have so little merit compared with its risks that reasonable health-care providers, possessing knowledge of risks that were known or reasonably should have been known, would not have prescribed the drug or device for any class of patients. thus, a prescription drug or medical device that bas usefulness to any class of patients is not defective in design even if it is harmful to other patients.93 many of the blood shield laws used the product service distinction to provide immunity from strict liability; however, in recent years this distinction bas become disfavored by many courts.94 the product service distinction does not provide sufficient guidance for a court when faced with considering patient safety if a medical product is not regulated by the fda in the same manner as drugs and medical devices. as discussed in supra part ii., tissue products do not have to be preapproved by the fda before release. this pre-market approval is a costly and time consuming regulatory process, but it is primarily focused on patient safety.95 the regulatory process imposed on drugs and medical devices is a balance between the cost and availability of drugs and medical devices and the reasonable expectation of patient safety by consumers of these products. certainly, if the. fda's regulatory standards were less stringent, more drugs and medical devices would be available at a reduced cost. however, this decreased cost and increased availability would come at 92. id. the third assumption rests on infinn ground when viewed in the context of tissue bank regulation. as discussed in supra part il, the fda does not require hctip to go through the pre-market approval process. tissue products must only meet minimal standards that protect patients from known risks of infectious disease. this assumption is based on the presumption that the fda will weigh the risks and benefits and ensure the health care community will be adequately informed about hctips. however, in the context of tissue bank regulation the manufacturer of a tissue product is allowed to decide if a hctip "raises new clinical safety concerns." .human cells, tissues, and cellular.and tissue-based. products: establishment registration and listing, 66 fed. reg. 5447,5459 (jan. 19, 2001). 93. restatement (third) of torts: products liability§ 6 cmt b (1998). 94. see david b. harrison, annotation, application of rule of strict liability in tort to person or entity rendering medical services, 100 a.l.r3d 1205 (2004). 95. see 1 james t. o'reilly, food and drug administration§ 18:8 (2d ed. 2004). 2005] blood shield laws and fda regulations 311 the expense of patient safety.96 this trade off for increased patient safety is accepted for drugs and medical devices, but when the fda considered increasing regulation over the tissue banking industry, it faced opposition from the industry stating that increased regulation was unnecessary to ensurepatient safety and would decrease availability. <.n although the detriment suffered by patients through fda regulation of drugs and medical devices is accepted, the tissue banking industry does not believe it is in the same class as drug and medical device manufacturers and therefore should not be strictly regulated. 98 interestingly, the regulatory process imposed upon drug and medical device manufacturers is one of the main presumptions employed by the ali to rationalize the relaxed standards of strict liability for these unique manuf­ acturers. nevertheless, patients are still at risk of severe injury or death from receiving a defective tissue graft just as they are from receiving a defective 96. for example, the explosively popular weight loss drug redox was marketed and sold in europe years before it received approval by the fda for distribution in the united states. see robert langreth. medicine: obesity drug appears close to approval, wail st. j., jan. 29, 1996, atb 1. however, this approval had tragic consequences for numerous patients. see david s. cloud & richard b. schmitt, probe aims to determine if diet-drug clearance merits criminal/nquiry, wailst.j.,sept. 9, 1999, ata3;laurajobannes& steve stecklow,redux panel was in the dark, wall st. j., dec. 11, 1997, at ai; edward r. silverman, diet pill revolution stalls amid concerns, dm st ar-i..edger, sept. 10, 1997, at 1. eventually, redux wasrecalledandremoved from the u.s. market amid concerns that prolonged use could damage heart valves. see alison r. mccabe, note, a precarious balancing act--the role of the fda as protector of public health and industry wealth, 36 suffolk u. l. rev. 787 (2003). this event demonstrates the value society places on patient safety. the general public is willing to make the trade offbetween increased cost and decreased availability to increase patient safety. the tissue banking industry should be provided with the correct incentives to mirror society's expectations of patient safety and corporate responsibility. 97. see letter from jamie m. grooms, regeneration technologies, to dockets mgmt. branch, docket no. 97n-484p, food & drug admin. (may 7, 2001), http://www.fda.gov/ ohrms/dockets/dailys/011may01/050801/97n_ 484p-c000015.pdf(lastvisitedapr.19,2005)(on file with the indiana health law review); see also letter from thomas l. craig, president, orthopedic surgical mfrs. ass'n to dockets mgmt. branch, docket no. 97n-484p, food & drug admin. (may 7, 2001), http:llwww.fda.gov/ohrmsldocketsldailys/ol/mayol/0508011 97n_ 484p-c000016.pdf (last visited apr. 19, 2005) (on file with the indiana health law review); letter from margery moogk, director, northwest tissue ctr., to dockets mgmt branch, docket no. 97n-484p, food & drug admin. (may 7, 2001), http://www.fda.gov/ ohrms/dockets/dailys/ol/mayol/050801197n_484p-c000014.pdf(lastvisitedapr.19,2005)(on file with the indiana health law review); letter from joel c. osborne, director of quality assurance and regulatory affairs, musculoskeletal transplant found., to dockets mgmt., docket no. 97n-484p, food & drug admin. (may 7, 2001), http://www.fda.gov/ohrms/ dockets/dailys/ol/may01/050801/97n_ 484p,.c000022.pdf(last visited apr. 19, 2005) (on file with the indiana health law review); letter from james c. vander wyk, phd., vice­ president, regulatory affairs and quality assurance, cryolife, inc., to dockets mgmt. branch, docket no. 97n-484p, food & drug admin. (may 7, 2001), http://www.fda.gov/ohrms/ dockets/dailys/ol/may01/050801/97n_ 484p-c000021.pdf(last visited apr. 19, 2005) (on file with the indiana health law review). 98. see letters supra note 97. 312 indiana health law review [vol. 2:295 drug. 99 patient safety is a prime concern for the general public. the current state of regulation of the tissue banking industry does not provide the proper incentives. additionally, the immunity the tissue banking industry enjoys poses a significant threat because manufacturers of tissue products are not motivated to protect patients in the same way as drug and medical device manufacturers. 100 v. cases defining tissue bank liability a. condos v. musculoskeletal transplant foundation in condos/01 one of two reported cases102 that have addressed the issue whether strict liability applies to tissue banks, the transplantee contracted hepatitis c virus after a bone graft was implanted.103 the transplantee brought suit· against the tissue bank. that distributed the graft and the company that processed the tissue. one of the transplantee's basis for recovery was a claim in strict liability; however, the court dismissed the transplantee' s strict liability claim.104 the court based its decision to dismiss· the strict liability claim on statutory and public policy grounds.10s the court determined that the utah blood shield statute (ubss) instructed it to construe the distribution and processing of blood and blood products as a service.106 interestingly, the statutozy language does not clearly 99. see dangers of tainted tissues hearings, supra note 18 (statement of jesse l. goodman. m.d., director of the fda center for biologics evaluation and research); cdc response to infections related to human tissue transplantation: hearings before the committee on governmental affairs, 108th cong. (2003) [hereinafter cdc response to infections hearings] (statement of steven l. solomon, m.d., acting director, division of healthcare quality promotion, cdc's national center for infectious diseases); human tissue banks hearings, supra note 26 (statement of kathryn c. zoon. ph.d., director, center for biologics evaluation and research, food & drug admin. dep't of health & human servs.); anna lumelsky, transplant tissue: cryolife human soft tissue implants recalled, 30 j.l. med. & ennes 474 (2002); septic arthritis following anterior cruciate ligament reconstruction using tendon allografts-florida and louisiana, 2000, so morbidity & mortautywkly.rep.l081 (2001);publichealthdispotch: update: unexplaineddeaths following knee surgery-minnesota. 2001,50 morbidity &mortautywkly. rep. 1080 (2001); claudia kalb, nasty infections; as the government cracks down on tissue banks, patients worry about safety and consider their options, newsweek, aug. 26, 2002, at 48. 100. see generally conk, supra note 55, at 1087 (arguing the restatement approach to strict liability as applied to medical products should be revised to provide the necessary incentives to protect against a medical disaster). 101. condosv.musculoskeleta1transplantfound.,208f. supp. 2d 1226(0. utah2002). 102. see id; cryolife, inc. v. super. ct. of santa cruz county, 2 cal. rptr. 3d 396 (cal. ct. app. 2003). 103. see condos, 208 f. supp. 2d at 1227-28. 104. ld at 1230. 105. ld at 1228-30. 106. idat 1230. 2005] blood shield laws and fda regulations 313 indicate it applies to tissue products.107 the court construed the statutory text stating: this statement recognizes that medical transfusions and transplants are essentially medical services, even though a' tangible item is involved in the process. accordingly, the court finds that human bone tissue is not a ''product" subject to products liability law, and that the distribution of human tissue, including reasonable payments for related services, does not constitute a "sale" for purposes of strict liability. 108 the court quickly dismissed the transplantee's argument that the absence of language expressly granting immunity implied tissue products should be subject to strict liability. 109 although the court appeared to refrain from making unnecessary implications from the statutory language, the court's construction practically rewrote the statute to shield tissue banks from strict liability even though the statutory language did not include tissue products. although the statutory text did not fully support the court's decision, the court believed that public policy strongly supported its decision to dismiss the strict liability claim. 110 it stated that the transplantee's public policy argument had some merit 111 the court recognized that the transplantee is in a parti­ cularly vulnerable position and that strict liability was created to protect the consumer in our complex society. 112 the court appeared to give some weight to public policy considerations of a person in the transplantee's position and may have ruled differently if it had not given so much weight to the statute. however, the court deferred to the legislature stating, ''this court is not in a position to decide state tort law policy, especially in light of the clear legislative policy indications to the contrary."113 107. the relevant section of the ubss states: the procurement, processing, distribution. or use of whole human blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing them into the human body together with the process of injecting or transfusing the same shall be construed to be the rendition of a service by every person participating therein and shall not be construed to be a sale. utah code ann.§ 26-31-1 (1998). 108. condos, 208 f. supp. 2d at 1230. 109. id. at 1229. the court reasoned, "[p]laintiffs' argument under the ubss is not persuasive. no court has ever applied strict liability to the distribution of human tissue .... [the ubss] cannot reasonably be read as an implied acknowledgment that other human tis8ue is a 'product' subject to strict liability." id 110. id. at 1230. 111. id at 1229. 112. id the condos court stated, "s1rict liability was created because of the limitations in negligence remedies and to protect consumers in an increasingly complex society. patients are helpless to prevent harm caused by infected human tissue distributed to hospitals for implantation or transfusion." id (citation omitted). 113. /d. 314 indiana health law review [vol. 2:295 the condos court then addressed policy statements in the restatement of torts114 and the policy indicated by the utah legislature through the unifonn anatomical gift act (uaga). 115 the uaga prohibits the sale of human tissues, 116 but allows for ''reasonable payment for the removal, pro­ cessing, disposal, preservation, quality control, storage, transportation, implan­ tation of a part, and administration of a procurement entity, including educa­ tional and other efforts to encourage anatomical gifts!'117 the court interpreted the uaga in relation to the situation as follows: "clearly, the utah legislature does not consider the manner in which mtf distributes human bone tissue to hospitals to be a 'sale.' mtf and osteotech are careful to only charge for the services they provide and properly disclaim any ownership of the bone tissue in their operating contracts."u8 the court in condos was careful to place the weight of its opinion on statutory construction rather than on public-policy grounds.119 however, the court failed to realize the importance of its decision in two respects. first, it failed to realize that it was the first court to rule on whether strict liability applied to tissue banks. second, it failed to address the issue that osteotech is a private company that processes tissue to generate a profit.120 implicit in the courts decision is the acknowledgment that the utah legislature and the courts will permit private companies to profit from an individual's final gift and shield those profits from plaintiffs who are injured by the products but never given the opportunity to make their case. b. cryolife, inc. v. superior court in cryolife, the plaintiff was a transplant patient who received a cada­ veric patellar tendon graft supplied by cryolife.121 two months after the surgical procedure, the surgical graft was removed from the plaintiff due to a bacterial infection.122 the plaintiff brought a cause of action in strict liability 114. "human blood and human tissue, even when provided commercially, are not subject to the rules of this restatement." ld (quoting restatement (1lmid) of torts: products liability§ 19 (1998)). additionally, the authors of the restatement state that this view is consistent with jurisdictions throughout the united states. id § 19 cmt. c. 115. utah code ann.§ 26-28-10 (2005). 116. id § 26-28-10(1). 117. id § 26-28-10(2). 118. condos, 208 f. supp. 2d at 1230. 119. id 120. see osteotech, inc., financial: financial highlights, at http:/lwww.osteotech.com/finhi.htm(lastvisitedapr.19,2005)(onfilewiththelndianahealth law review). in 2003, osteotech 's gross profits were $52.3 million-fifty-five percent of its revenue. /d. it appears that the court was willing to accept that a charge generating a fifty-five percent profit is reasonable for the processing ofhuman tissue under the uaoa. 121. cryolife. inc. v. super. ct. of santa cruz county. 2 cal. rptr. 3d 396. 398 (cal. ct. app. 2003). cryolife is a "tissue bank in the business ofharvesting, preserving and distributing products derived ftom human tissue for medical use." /d. 122. id 2005] blood shield laws and fda regulations 315 pleading the following: the tissue product was not fit for its intended use; cryolife had failed to warn either the plaintiff or the health care provider of the risks ~sociated with the use of this tissue product; the tissue product,was defective; the tissue was inadequately tested and treated; cryolife misled the plaintiff and health care providers about the safety of the product;123 and cryolife had maliciously denied that an infection could be caused by the tissue graft. 124 the trial court refused to dismiss the strict liability claim.125. ·· when cryolife appealed the trial court's decision, the appellate court dismissed the plaintiff's strict liability claim. 126 the appellate court based its decision to dismiss on statutory and public policy grounds.127 the court looked to california's blood shield law to determine if the legislature had granted immunity from strict liability to tissue banks.128 interestingly, this section of the statute does not include a reference to tissue banks. however, another section of the california health and safety code grants tissue banks immunity, 129 but this statute is phrased differently than the statute addressing blood products. the statute addressing tissue banks reads: 123. cryolife has not been a particularly good corporate citizen when it comes to the safety of their products. in august 2002, the fda stated: after determining that cryolife failed to take adequate corrective measures to address possible infectious disease contamination of tissue, and after reviewing informationprovidedbythefirminresponsetofda'swarnings,fdaissuedthe present order for retention, recall and/or destruction of allograft tissues other than allograft heart valves, and is issuing this web notification to physicians regarding fda's recommendations for both allograft heart valves and other allograft tissues. fda's concerns described in the order relate specifically to bacterial and fungal contamination of soft tissues, such as cartilage and tendons. crr. for devices & radiolooical health, food & drug admin., fda pubuc healm web notification: human tissue processed by cryoijfe. inc. (aug. 21, 2002), at http://www.fda.gov/cdrh/safety/humantissue.html (last visited apr. 19, 2005) (on file with the indiana health law review). for a brief overview of this recall see lumelsky, supra note 99. 124. cryolife, 2 cal. rptr. 3d at 398. 125. id at 400. 126. id. at 408. 127. id. at400-05 128. cal. healm & safety code § 1606 (west 2005). california's blood shield law states: !d. the procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into the human body shall be construed to be, and is declared to be, for all purposes whatsoever, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of such whole blood, plasma, blood products, or blood derivatives, for any purpose or purposes whatsoever. 129. in california, a tissue bank is defined as "anyplace, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings." cal. healm&safetycode § l635(d)(west2005). 316 indiana heal til law review [vol. 2:295 the legislature hereby declares its intent that the collection, processing, storage, or distribution of tissue for the purpose · .of· transplantation, as regulated by this chapter, shall be ; deemed a service by those persons engaged in these activities. · .·.therefore, the collection, processing, storage, or distribution of tissue for the purpose of transplantation, as regulated by this chapter, shall not be subject to the requirements of division 2 (commencing with section 2101)130 of the com­ mercial code.131 clearly, the language in the section addressing tissue banks is very different from the blood product sections. the plaintiff claimed that the differences in the statutory language indicated that the legislature only intended to prevent application of the commercial code and not grant immunity to tissue banks.132 however, the court did not find the plaintiff's argument persuasive.133 the court stated the rationale behind the blood shield law was that the supplying of blood was incidental to the services provided by a hospital and there is strong public policy in favor of maintaining an adequate supply of blood.134 the court then addressed the section that applied to tissue banks: the statute is unequivocal in its plain language, placing no limits on the circumstances in which a tissue bank will be deemed to have provided a service .... "[i]f statutory langu­ age is 'clear and unambiguous there is no need for construc­ tion, and courts should not indulge in it. "'135 the court construed the plain meaning of the statue as follows: "therefore, by expressly excluding the application of the sales and warranty provisions of the commercial code to 'the collection, processing, storage, or distribution of tissue for the purpose of transplantation,' 136 the legislature implicitly excluded such tissue-related activities from the application of the doctrine of strict liability."137 although the statute did exclude tissue banks from the commercial code, the statute did not explicitly provide immunity from strict liability. the court decided not to rest its entire opinion on statutory construction. the court analyzed other statutory sections and court decisions to provide additional 130. division 2 of the commercial code concerns the sale of goods. 131. cal.heal.lh&safetycode § 1635.2 (west2005). 132. cryolife, 2 cal. rptr. 3d at 402. 133. /d. 134. /d. 135. id (quoting tieman v. trustee of cal. state. univ. & colleges, 33. cal. 3d. 211,218 (cal. 1982)). 136. cal. heal1h & safety code § 1635.2 (west 2003). 137. cryolife, 2 cal. rptr. 3d at 403. 2005] blood shield laws and fda regulations 317 support for its decision. first, the court stated that the unifonn. anatomical gift act (uaga)138 "also demonstrate[ s] the legislature's broad intent that the provision of human tissue not be considered a sale of goods or products. " 139 the court looked to the section in the uaga that allowed payment for tissue related services. 140 second, the court stated that it was a crime141 to knowingly sell human tissue for the purpose of transplantation. 142 third, the court analogized tissue banking to the services provided by a pharmacist 143 in a case involving a strict liability claim against a pharmacist, the california supreme court concluded that the pharmacists had statutory immunity from strict liability similar to that granted by the blood shield law even though pharmacists sell a product and are compensated for their service.144 the court placed significant weight in this analogy stating: when the legislature enacted section 1635.2 in 1991 as part of a regulatory scheme for tissue banks, it had to know that tissue banks are paid for their activities in connection with providing human cadaver tissue for medical use. by expressly deeming such activities to constitute a service, the legislature must have intended a tissue bank to be immune from strict liability, just like a pharmacy.14s finally, the court cited condos146 and the restatement147 as additional authority in accord with its opinion. 148 next, the court found that public policy supporting blood shield laws also supported immunity for tissue banks. 149 the court explained its position stating: 138. cal.healrn&safetycode §§ 7150-7157 (west2005). the uniform anatomical gift act provides, "[a] person may not knowingly, for valuable consideration, purchase or sell a part for transplantation, therapy, or reconditioning, if removal of the part is intended to occur after the death of the decedent .... " id § 7155(a). 139. cryolife, 2 cal. rptr. 3d at 403. 140. /d. "however, payment for tissue-related services is allowed, including 'the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of a part.'" ld (quoting cal. healtii& safety code§ 7155(b)) (west2003). 141. cal. penal code§ 367f{cx1) (west 2005). 142. cryolife, 2 cal. rptr. 3d at403. 143. ld. 144. see murphyv. e.r. squibb & sons, inc., 221 cal. rptr. 447 (cal. 1985). 145. cryolife, 2 cal. rptr. 3d at 404 (footnote omitted). 146. condos v. musculoskeletal transplant found., 208 f. supp. 2d 1226 (d. utah 2003). 147. restatement {third) of torts: producfsliabiuty § 19 (1998). 148. cryolife, 2 cal. rptr. 3d at 404. 149. id at 405. "[w]e see no reason that the public policy rationale for exempting blood products from strict liability should not also apply to human tissue products, such as the allograft at issue in the case at bar." id 318 indiana heal1h law review [vol. 2:295 in our view there is a legitimate state interest in manufactured blood products. we concur in the perception that "legisla­ tures have determined that the production and use of human blood and its derivatives for therapeutic purposes should be encouraged; and for this purpose those who provide these products, and who are themselves free from fault, should not be required to bear the economic loss which might otherwise be imposed under the rules of strict liability which are applic­ able to sellers of commercial products generally." the california statutory provisions we have discussed reflect a similar legitimate state interest in human tissue products used for therapeutic purposes.1so the court in cryolifo found it easy to analogize the activities engaged in by tissue banks to the activities of pharmacists and blood banks. however, the court failed to realize the true differences between blood banks and phar­ macists as compared to tissue banks. tissue banks do not provide a product incidental to a professional service. rather, tissue banks actually process human tissue to create a product they market and sell to health care providers. if the court had taken a legitimate look into the tissue banking industry, it would have found real differences that set tissue banking apart from professionals that merely provide a product incidental to a service. neverthe­ less, it still stands in question whether the rationale supporting blood shield laws would logically apply if a court effectively considered the activities of the tissue banking industry. vi. plasma fractionation industry and patient safety coagulant factors, produced by the plasma fractionation industry, lsi are used to treat severe cases of hemophilia. 152 coagulant factors and tissue products are direct derivatives from the human body. in tum, these blood products produce similar risks to patient safety when compared to tissue products due to the numerous diseases that are blood-borne, particularly hepatitis and hn. as is evident, the regulation of the fractionation industry is analogous to the regulation of the tissue banking industry in that the fda depended on the industry to police itself. however, this regulatory approach 150. ld. (quoting hyland therapeutics v. super. ct., 175 cal. app. 3d 509,516 (cal. ct. app. 1985)). 151. the plasma fractionation industry acquires plasma from whole blood collectors and plasma collection centers. after collection, the plasma is sent to a laboratory where it is further separated into proteins through a process called fractionation. hlv and the blood supply, supra note 10, at 29-31. 152. for a primer on hemophilia see hemophilia association, information, at http://www.hemophiliaz.org (last visited apr. 19, 2005) (on file with the indiana health law review). 2005] blood shield laws and fda regulations 319 coupled with immunity from strict liability devastated the hemophiliac population while allowing only minimal compensation for their injuries. currently, blood clotting factors used to treat severe hemophiliacs are processed using heat treatment or chemical detergents to inactivate the· hn virus. 153 however, viruses were not always inactivated in blood clotting factors released to the public. instead, the plasma :fractionation industry did not.attempt to deactivate any virus in their clotting factors until it was ro-o·late to prevent the hemophiliac population from being devastated by hn. 154 although it may appear that the hn outbreak in hemophiliacs was the impetus for the development of viral inactivation technology, it is important to look at the development of technology that could have prevented the spread of hepatitis in hemophiliacs.155 technology that would have deactivated the hepatitis virus would have also prevented the spread of aids to many hemophiliacs. 156 disturbingly, hepatitis was considered a reasonable risk, 157 but in a relatively short period of time, this reasonable risk ofbeing infected by a blood borne pathogen became devastatingly unreasonable requiring action that could have been taken years before to eliminate this risk. the patients who receive tissue products are likely heading down this same path. is it reasonable to make the same mistake twice? the processing techniques used by the plasma fractionation industry greatly increased the risk that a hemophiliac would contract a virus from clotting factors. 158 the plasma fractionation industry knew of the substantial risk of hepatitis infection to hemophiliacs consuming their products shortly after clotting factors were introduced. 159 however, no steps were taken at that time to eliminate or reduce this risk even though blood derivative products had been heat treated since the nineteen-forties to destroy viruses.160 in 1983, the plasma fractionation industry finally began to implement viral inactivation techniques; however, according to the institute of medicine, viral inactivation technology could have been developed before 1980 and prevented many cases ofhn in hemophiliacs.161 in 1976, research had begun on the feasibility of using chemical solutions to inactivate the hepatitis virus in clotting factors while maintaining 153. hlv andtiiebloodsupply,supranote 10,at81. 1 54. see /d. at 81-96; humanlmmunodef~eiency v"rrus infection in the united states, supra note 58, at 801. 155. see hlv and tile blood supply, supra note 10, at 81. 156. ld. at 5. 157. ld. at 93. 158. id. at 5. "in fact, the methods used to manutacture ahf concentrate can also inadvertently concentrate certain viruses, present in the original plasma donation, within the final product preparation. the tact that ahf concentrate is prepared from pooled plasma from thousands of donors greatly increases its risks for transmitting disease." jd. at 81. 159./d. 160. id 161. hlv andtiiebloodsupply,supranote 10, at 95. 320 indiana heal1h law review [vol. 2:295 therapeutic value.162 these studies proved to be unconvincing, and hepatitis still remained the major risk for hemophiliacs using clotting factors in 1978.1·63 by the early nineteen-eighties, several companies within the plasma fractiona­ tion industry were developing heat treating methods to inactivate viruses. "there was, however, little if any communication between the different manu­ facturers regarding the results of the ongoing experiments, because of antitrust laws, regulations, and the normal business consideration of competitive advantage;"164 the manufactures in the plasma fractionation industry were for-profit organizations driven by a desire to gain a competitive advantage over their rivals. the competitive atmosphere coupled with the view that hepatitis was an "acceptable risk for individuals with hemophilia because it was considered a medically manageable complication of a very effective treat­ ment for hemophilia" proved to be very dangerous for hemophiliacs. ~65 although the manufacturers were developing technology to inactivate the viruses, one major concern in the implementation of the technology was the ''potential additional cost of implementing the process. "166 the regulatory framework, including fda regulations and blood shield laws, placed the decision and motivation to develop viral inactivation method in the hands of the for-profit plasma fractionation industry.167 is it really rational to place patient safety in the hands of organizations that stand to gain if they produce a product that is just "safe enough" to pass their own standards? "[t]he impelling motive and decision to develop viral inactivation methods depended almost entirely on the plasma fractionation industry."168 the fda's role in the development of viral deactivation technology for clotting factors was very small. first, the fda considered the transmission of hepatitis to be an acceptable risk and did not believe it was urgent that this technology be developed. 169 second, the fda, at that time, did not have the appropriate expertise to develop viral inactivation methods believing the expertise resided within the manufactures of the products "and that innovations would eventually emerge."170 third, even if the fda wanted to pursue viral inactivation methods, the fda had very limited personnel for regulatory oversight and limited internal facilities and support in the early nineteen­ eighties.171 162. jd. at 86 (citations omitted). 163. ld 164. ld at 88. 165. jd at 93. 166. /d. at 89. 167. hiv andtiiebloodsupply,supranote 10,at93-4. 168. id 169. id at 94. 170. /d. 171. /d. 2005] blood shield laws and fda regulations 321 due to the fda's limited role and resources, the fda looked to the industry to develop viral inactivation technology. however, the industry did not have the proper incentives in place: [t]he factors that influenced the pace of viral inactivation · technologies developed by industry included interest in gaining competitive advantage and concerns over yield and cost. while these concerns are understandable from the per­ spective of a manufacturer, in the absence of active encour­ agement by the fda these concerns probably inhibited expeditious progress in inactivation technologies. further, with the primary responsibility for the development of viral inactivation methods left to industry, inherent limitations were placed on the free exchange of scientific and technical information that might expedite product development efforts. operating in a competitive market, manufacturers are not inclined to share the details of their research efforts; and the fda is legally barred from sharing a company's research findings among competitors. companies interacting among each other could be in violation of antitrust laws and face potential criminal charges; fines, and sanctions. furthermore, the very nature of the competitive world of business is one that normally would cause a company to preserve manufac­ turing processes and research results for its own benefit, to enable the marketing of products at a competitive advant­ age.172 the institute of medicine stated that the "heat treatment processes to prevent the transmission ofhepatitis could have been developed before 1980, an advance that would have prevented many cases of aids in individuals with hemophilia."173 the institute believed the plasma fractionation industry was not properly encouraged to develop heat treating technology before hn ravaged the hemophiliac population. it stated that "[ s ]trong incentives to maintain the status quo and a weak countervailing force concerned with blood product safety, combined to inhibit rapid development ofheat-treated products by plasma fractionation companies."174 one strong incentive that was completely removed was the threat of civil litigation through strict liability. strict liability could have proved to be a strong incentive for the plasma fractionation industry to develop viral inactivation methods before hn 172. id. at 94-5 (emphasis added). 173. hiv andtiiebloodsupply,supranote 10, at95. 174. id at 96. 322 indiana health law review [vol. 2:295 devastated hemophiliacs. however, strict liability was never a viable option for hemophiliacs except in a few isolated circumstances.175 the story ofhn and hemophiliacs clearly indicates that the legislatures failed to. ·create the proper incentives for for-profit organizations. , the legislatures also failed to implement a regulatory system capable of p~perly addressing the unique risks associated with products derived from the ·human body. to add insult to injury, the legislatures provided immunity from strict liability for the manufactures of these uniquely dangerous products. the blood shield laws and regulatory system combined to prove devastating to hemophiliacs by failing to place the proper incentives on patient safety. this approach allowed pharmaceutical companies to maximize profits at the expense of patient safety. vll. ·the consequences of blood shield laws because of the enactment of blood shield laws in forty-eight states, injuries related to blood products cannot be pursued under a theory of strict liability. 176 blood shield laws are intended to protect the general public by ensuring an adequate supply of blood. 177 ae. a consequence of these laws, hemophiliacs, infected with hn by blood products, have found it nearly impossible to obtain compensation from the plasma fractionation industry.178 this statutory immunity coupled with scant regulation exposed a weakness in this system in the early nineteen-eighties-"its ability to deal with a new threat that was characterized by substantial uncertainty."179 the system demonstrated its weakness in its inability to properly address patient safety. this weakness exacerbated the infected hemophiliac's poor position. in turn, severe hemophiliacs were left with a failed regulatory system and no remedy or recourse for their injuries. however, congress did address the injuries suffered by hemophiliacs in the nineteen-eighties through the ricky ray hemophilia relief fund act of 1998.'80 the act provides $100,000 for each eligible individual.181 the act provides very broad coverage, most likely a result of the substantial uncertainty during the relevant 175. see supra part n.a. 176. hn and the blood supply, supra note 10, at 223-24. 177. see/d. 178. see/d 179./d at2. 180. 42 c.f.r. §§ 130.1-130.50 (2005). [t]this statute provides for compassionate payments to certain individuals with blood-clotting disorders, such as hemophilia, who contracted human immuno­ deficiency virus (hn) due to contaminated antihemophilic factor within a specified time period, as well as to certain persons who contracted hn from these individuals. in the event the individual eligible for payment is deceased, the act also provides for payments to certain survivors of this individual. /d.§ 130.1. 181. /d. § 130.3. 2005] blood shield laws and fda regulations 323 time period.182 congress did not make it difficult for hemophiliacs to qualify for the program; an individual is covered by the act with the submission of a simple affidavit, no extensive medical evaluation or medial record documen­ tation is required.183 the act was unfunded for two years, until 2000, when congress finally appropriated $105,000,000 to fund the compensation program.'84 as noted by the debates on the house and senate floor, the majority of our representatives believed that hemophiliacs should be compensated for their loss due to the inaction by federal agencies. 185 however, in the end, hemo­ philiacs were· given meager compensation for the losses they suffered due to no fault of their own. the question is did our regulatory agencies and legisla­ tures learn anything? vlll. the tissue banking industry poses the same risks to patient safety as the plasma fractionation industry three factors indicate the tissue banking industry has the potential to harm recipients in a similar way the plasma fractionation industry injured hemophiliacs. first, the fda lightly regulates the tissue manufacturing industry relying on the organizations that the fda is policing to set the proper standards.186 second, courts are unwilling to motivate the tissue banking industry to develop new technology to enhance patient safety. as condos187 and cryoliftl88 demonstrate, courts are willing to immunize tissue banks from strict liability using the same rationale that prevented hemophiliacs from receiving compensation after the regulatory system failed to properly address 182. id. § 130.10. "an individual who has any form of blood-clotting disorder, such as hemophilia, who was treated with antihemophilic factor at any place defined in § 130.2( o ), ... at any time during the time period from july 1, 1982, to december 31, 1987." id. /d. 183. id. § 130.20. in all instances in which medical documentation is referred to, medical documentation may be submitted in the following forms: (a) copies of relevant portions of medical records, records maintained by a physician, nurse, or other licensed health care provider, test results, prescription information, or other documentation deemed credible by the secretary; or (b) an affidavit, signed under penalty of perjury, by a physician, nurse practitioner or physician assistant, verifying that the medical criteria necessary for a petitioner to be eligible for payment under the act are satisfied. such an affidavit must include the physician's, nurse practitioner's or physician assistant's state of practice, and license, certification or registration number, as applicable. 184. see consolidated appropriations act, h.r. 4571, 106th cong. § 150 (2001). 185. see l44cong.rec.3377(1998); 144cong.rec.12912(1998). 186. see supra part ii. 187. condos v. musculoskeletal transplant found., 208 f. supp. 2d 1226 (d. utah 2002). 188. cryolife, inc. v. super. ct. of santa cruz county, 2 cal. rptr. 3d 396 (cal. ct. app. 2003). 324 indiana heallh law review [vol. 2:295 the unique risks associated with clotting factors.189 third, tissue products are manufactured from donated human tissue that carry the same risk as clotting factors in that they are derived from the human body and considered unavoidably dangerous but medically necessary. 190 if these factors are not properly addressed, tissue recipients could face the same fate as hemophiliacs but on a much larger scale.191 ix. patient safety can be enhanced while ensuring an adequate supply of donated human dssue by imposing strict liability on dssue processors a. proper incentives must be created to enhance patient safety blood shield laws should be reformed to heighten awareness for patient safety throughout the tissue banking industry for several reasons. first, tissue processing cannot effectively remove all contaminants which would make the products safe. 192 the unique nature of a human-based product makes the tissue product recipients susceptible to communicable diseases that go undetected by tissue processors. second, the risk of infection or death is real. several patients have either died or become seriously ill after receiving a tissue graft.193 third, for-profit tissue companies are under constant pressure to maximize profits and increase their market share; therefore, these tissue processors' decision-making is heavily influenced by market considerations and profit 189. hemophiliacs were eventually allowed meager compensation for their injuries related to clotting factors. see supra notes 181, 184, and accompanying text discussing the ricky ray hemophilia relief fund act. however, congress did not feel the need to compensate individuals who were infected with mv through means other than clotting factors. one possible distinction that can be drawn is that clotting factors were produced by for profit companies that may not have been properly motivated by the regulatory scheme to adequately consider patient safety. 190. see supra part v. 191. hemophiliaassociation, lnfonnation: hemophilia a, athttp://www.hemophiliaz.org (last visited apr. 19, 2005) (on file with the indiana health law review) (stating that about 17,000 people throughout the united states have hemophilia). however, an estimated 800,000 tissue grafts were transplanted in 2002. dangers of tainted tissues hearings, supra note 18 (statement of jesse l. goodman, director of the fda center for biologics evaluation and research). if an undetectable, untreatable disease were to strike the tissue graft recipient population, the impact would be devastating due to the growing use of cadaveric tissue grafts. 192. current good tissue practice for manufacturers ofhuman cellular and tissue-based products; inspection and enforcement, 66 fed. reg. 1508, 1509 (proposed jan. 8, 2001). 193. see id. at 1540-42; cdc response to infections hearings, supra note 99 (statement of steven l. solomon, m.d., acting director, division of healthcare quality promotion, cdc's national center for infectious diseases); dangers of tainted tissues hearings, supra note 18 (statement of jesse l. goodman, director of the fda center for biologics evaluation and research); lumelsky, supra note 99, at 474; unexplained deaths following knee surgery --minnesota, november 2001, supra note 99, at 1080; septic arthritis following anterior cruciate ligament reconstruction using tendonallogrqfts, supra note 99, at 1081; blakeslee, supra note 20, at 1.; kalb, supra note 99, at 48. 2005] blood shield laws and fda regulations 325 rather than patient safety and society's concept of donation. if the tissue donation process is influenced in a way that is contrary to public interest, society's concept of organ and tissue donation will be negatively impacted further exacerbating the already critical organ shortage.194 these concerns must be addressed to ensure that human tissue products continue to be readily available. b. strict liability is a practical incentive for-profit organizations can only be motivated by either government regulation or civil liability because their existence is defined by profit or the promise of profit the fda has demonstrated its unwillingness or inability to regulate the industry without practically allowing the industry to craft its own regulations. additionally, the fda could not possibly keep pace with this rapidly developing industry. a practical alternative to increased and costly regulation is the imposition of strict liability using the reasonable alternative test. if an unreasonable practice leads to injury, imposing strict liability on the tissue banking industry is a rational way to disgorge profits from the industry thereby creating an economic incentive to make changes in the interest of patient safety. because for-profit organizations are already entrenched in the tissue banking industry, new laws that would forbid or limit for-profit companies from participating in the tissue banking industry would certainly face fierce opposition, making enactment extremely costly and nearly impossible. how­ ever, strict liability is a practical solution because eliminating the statutory shield, an abrogation of common law, only requires legislatures to revise existing laws or, in some states, courts to construe blood shield laws narrowly. c. the rationale behind strict liability and the alternative safer design analysis the rationale behind strict liability is that the consumer of a product expects and relies on the manufacturer to produce a safe product along with 194. see consent in nssue donation, supra note 19; human tissue banks hearings, supra note 26 (statement of william minogue, m.d., cbairmao. board of directors, washington regional transplant consortium). dr. minogue stated: id to ensure that people remain willing to donate, they must trust the donation system. the organ and tissue recovery process affects people when they are most vulnerable. this circumstance can easily give rise to misunderstanding. causing suspicions that their loved one is being nudged toward premature death so that organs and tissues can be taken for the benefit of others. the public must have every confidence that no one will directly profit ftom the death of their loved ones and that the donation system will work to protect them and their loved ones ftom abuse or misuse. 326 indiana health law review [vol.2:29s this reliance comes the expectation that the consumer will be compensated for injuries that result from an accident caused by the product. in turn~ the cost of accidents caused by the products are incorporated into the cost of the product and distributed throughout the entire consumer population. therefore, the cost of the product represents its true cost. the most important aspect of strict liability is that the manufacturer, which directly bears the cost of the accident, is in the best position to anticipate, prevent, or remedy any injury ot risk associated with the product. this is the special responsibility assumed by all manufacturers in society.195 it is engrained in the conscience of society that the manufacturer of a defective product should be held liable for the injury caused by a defect. tissue based products offer a unique challenge to strict liability because they are inherently dangerous; however, tissue products can be designed in a way that significantly reduces the inherent risks. 196 the restatement (third) of torts: products liability states a product is defectively designed ''when the foreseeable risks ofharm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller ... , and the omission ofthe alternative design renders the product not reasonably safe .... "197 the reasonable alternative standard allows the design of a product to be considered with the state of technology in the industry at the time the product was manufactured. the reasonable alter­ native standard also allows the manufacturer to escape liability if an alternative design was not feasible but still serves the fundamental purpose of the tort system, which is: [t]o identify socially unreasonable conduct and to compen­ sate the victims of such conduct: "the issue in every products case is whether the product qua product meets society's standards of acceptability[;] ... whether ... we as a society will·live with it in its existing state or will require an altered, less dangerous form. stated succinctly, the question is 195. restatbmbnt (second) of torts § 402a cmt c (1965); see, e.g., east river s.s. corp. v. transamerica delaval, inc., 476 u.s. 858 (1986); castro v. qvc network, inc., 139 f.3d 114 (2d cir. 1998); greenman v. yuba power prods., inc., 59 cal. 2d 57 (cal. 1963); puckett v. oakfabco, inc., 979 p .2d 1174 (idaho 1999);-mccathern v. toyota motor corp., 23 p.3d 320 (or. 2001); green v. smith & nephew ahp, inc., 245 wis. 2d 772 (wis. 2001). 196. see cdc response to infections hearings, supra note 99 (statement of steven l. solomon, m.d., acting director, division ofhealthcare quality promotion, cdc's national center for infectious diseases).· 197. restatbmbnt (third) of torts: products liabiiny § 2(b) (1998); see, e.g., mccourt v. j. c. penney co., 734 p.2d 6% (nev. 1987); micallefv. miehle co., div. of miehle-oossdexter, inc., 348n.e.2d571 (n.y. 1976); lancaster silo& block co. v. northern propanegasco.,427n.y.s.2d 1009(n.y. app. div.l980);fordmotorco. v. nawak, 638 s.w.2d 582 (tex. app. 1982). 2005] blood shield laws and fda regulations whether the product is a reasonable one given the reality of its use in contemporary society. "198 d. strict liability applied to tissue banks 327 the application of the reasonable alternative standard would not impose upon tis8ue manufactures an absolute duty not to injure. instead, the manu­ facturers would be required to act ethically iri. the light of the state of the technology at the time the product is manufactured and marketed. 199 the rea­ sonable alternative standard shifts some risk to the manufacturers forcing them to consider patient safety when designing and marketing products. therefore, the risk associated with tissue transplantation is equitably distributed thereby meeting the expectations of society. additionally, the supply of human tissue grafts would not be decreased by implementing the reasonable alternative standard. some tissue manu­ facturers claim their processing techniques sterilize tissue without damaging the integrity of the graft 200 therefore, the tissue banks that are able to produce a reasonably safe product would gain access to more tissue as less credible tissue processors fail to obtain liability insurance and cease operations. in turn, the industry as a whole would become more efficient and increase the availability of a scarce resource, donated human tissue. patient safety and increased access to tissue products are not the only benefits that could be derived from strict liability on tissue manufacturers. first, imposing liability on manufacturers of tissue products will force the bad seeds out of the industry and reward the organizations that meet their ethical obligations. in tum, donation is likely to increase if the public believes their gift is being used in the most beneficial and respectful manner. if unethical companies are forced out of the industry, the issues concerning informed consent and questjonable behavior by recovery agencies will be addressed by ethical processors refusing to conduct business with recovery agencies acting in bad faith. second, for-profit tissue processing companies will be forced to carefully evaluate their decision making process because a jury of average american citizens is not likely to accept profits as a justification for the unethical, wasteful, or undesirable use of donated human tissue. it is almost unconscionable to think our friends and family are asked to donate in a time of great sorrow and allow organizations to reap tremendous profits from a 198. conk, supra note ss, at 1117 (quoting william a. donaher et al., the technological expert in products liability litigation, 52 tex. l.rev. 1303, 1307 (1974)). 199. id at 1123-24. 200. see regeneration technologies. inc., safety · & testing: biocleanse™ tissue sterilization process, at bttp://www.rtix.com/safetylbiocleanse.cfin (last visited apr. 19, 2005) (on file with the indiana health law review). 328 indiana health law review [vol. 2:295 loved one's death with almost absolute immunity from liability. finally, the government would not run the risk of subsidizing an industry that made poor decisions during a time of crisis. x. conclusion tissue based products have inherent risks that must be controlled to meet society's expectation of patient safety and ensure that society's image of donation is not tarnished. the fact that several large organizations processing human tissue exist to profit from donation indicates these organizations are moving away from their roots and becoming corporate giants consumed by profit. this shift is contrary to society's belief that donation is motivated by altruism and not profit. as evidenced, tissue products present a real risk of severe infection or death. despite this risk, courts and the fda are unwilling to scrutinize the industry and impose appropriate incentives for patient safety on the tissue banking industry. removing the statutory banier created by blood shield laws and imposing strict liability on the tissue banking industry would provide the appropriate incentives on the industry without unduly burdening supply or innovation. however, if the safety concerns are not addressed and the injuries from donated tissue increase, a medical disaster could occur similar to the hemophiliac hiv epidemic in the nineteen-eighties, but on a much larger scale. a medical disaster involving human tissue grafts would have a detrimental effect on society's image of donation. if the public became informed of the for-profit nature of the tissue banking industry and the poor incentives created for patient safety in the context of a.medical disaster, donor families are likely to believe they have been exploited by the for-profit tissue banking industry while the government stands in defense of the industry's profit. thus, strict liability should be used as a conduit to carry society's expectations of donation into the tissue banking industry. microsoft word 1-masthead vol. viii.doc james r. copland james r. copland is the director of the manhattan institute’s center for legal policy, which seeks to develop and communicate thoughtful ideas on how to improve the civil and criminal justice system. copland serves as managing editor of the institute’s pointoflaw.com, a web magazine that brings together information and opinion on the u.s. litigation system; project manager for the institute's trial lawyers, inc. series of publications examining the size, scope, and inner workings of america’s lawsuit industry; and research director of the institute’s proxymonitor.org web platform, which tracks shareholder proposals submitted to public corporations. prior to joining the manhattan institute, copland was a management consultant with mckinsey and company in new york. he had earlier served as a law clerk for ralph k. winter on the united states court of appeals for the second circuit. he has been a director of two privately held manufacturing companies since 1997. copland received j.d. and m.b.a. degrees from yale, where he was an olin fellow in law and economics and an editor of the yale journal on regulation. he also has an m.sc. in politics of the world economy from the london school of economics and a b.a. in economics with highest distinction and highest honors from the university of north carolina at chapel hill, where he was a morehead scholar. administrative compensation for pharmaceuticaland vaccine-related injuries james r. copland* i. introduction ............................................................................... 277 ii. pharmaceutical regulation i: the food and drug administration ........................................................................... 278 iii. pharmaceutical regulation ii: the tort system ............... 281 iv. a special administrative system: the vaccine injury compensation program............................................................. 284 v. pharmaceutical economics: putting vaccines in context ........................................................................................ 285 a. supply-side factors ................................................................. 285 b. demand-side factors ............................................................... 286 c. externalities ............................................................................. 287 vi. administrative compensation for pharmaceuticals and medical devices ................................................................. 287 a. field preemption of pharmaceutical claims, with limited carve-outs ............................................................................... 288 b. limitation of most claims to unforeseen adverse events ...... 289 c. clearly defined causation and injury requirements .............. 289 d. independent post-market drug monitoring ............................ 289 e. system funding ........................................................................ 289 vii. conclusion .................................................................................. 290 i. introduction over the last four years, the supreme court has decided a trilogy of federal preemption cases running the gamut of modern medical product liability litigation: 2008’s riegel v. medtronic,1 finding that state tort claims stemming from injuries allegedly caused by certain medical devices were * james r. copland is the director of the center for legal policy at the manhattan institute. several of the concepts in this essay were first developed in the following report: james r. copland & paul howard, manhattan inst. for pol’y res., in the wake of wyeth v. levine: making the case for fda preemption and administrative compensation (mar. 2009), available at http://www.manhattan-institute.org/html/ fda_01.htm. mr. copland would like to thank the following: cathy sharkey of nyu law school for the invitation to present on this topic; larry mone, president of the manhattan institute, for supporting his research; and mr. howard, richard epstein, howard husock, ben gerson, and matthew hennessey for editorial suggestions. all errors are his alone. mr. copland would like to disclose that he owns common shares in various pharmaceutical and other health care companies, directly and indirectly, as part of a diversified equity portfolio. 1. riegel v. medtronic, inc., 552 u.s. 312 (2008). 278 indiana health law review [vol. 8:2 expressly preempted by the 1976 medical devices amendments to the food, drug, and cosmetics act (“fdca”);2 2009’s wyeth v. levine,3 failing to find that a state common law failure-to-warn claim for a drug was impliedly preempted by the broader fdca; and 2011’s bruesewitz v. wyeth,4 finding that the 1986 national childhood vaccine injury act (“ncvia”)5 expressly preempted state common law design defect claims for children’s vaccines. these cases demonstrate the interplay between the two very different systems used in the united states to regulate medical products: the comprehensive, ex ante review and oversight administered by federal regulatory agencies; and the decentralized, ex post private tort system enforcing state common law rules through civil juries in state and federal court. in recent years, i have been both a critic of the tort system’s handling of pharmaceutical litigation and an advocate for much broader preemption of such claims, in light of federal regulatory oversight. i have also advocated, concurrently, that the federal government implement an administrative compensation program—akin to the vaccine injury compensation program (“vicp”) at play in bruesewitz—to provide a remedy to at least some classes of individuals injured by drugs and devices notwithstanding the federal regulatory scheme.6 this essay, adapted from a presentation at the american association of law schools, considers, in turn, each of the american systems of pharmaceutical regulation. the essay then briefly describes the vaccine injury compensation program and considers how the law and economics of the vaccine market varies from that of the broader market for pharmaceuticals and medical devices. the essay concludes with a proposal for broad preemption of state tort law claims, alongside an administered system that would process product-related injuries. ii. pharmaceutical regulation i: the food and drug administration under the fdca, the federal food and drug administration (“fda”) oversees a comprehensive regulatory regime governing the u.s. market for all pharmaceuticals and medical devices. in this section of this essay, i briefly overview the fda’s process and assess the degree to which the tort 2. see 21 u.s.c. § 360. 3. wyeth v. levine, 555 u.s. 555 (2009). 4. bruesewitz v. wyeth, 131 s. ct. 1068 (2011). 5. see 42 u.s.c. §§ 300aa-1 et seq. 6. see generally james r. copland & paul howard, manhattan inst. for pol’y res., in the wake of wyeth v. levine: making the case for fda preemption and administrative compensation (mar. 2009), available at http://www.manhattaninstitute.org/html/fda_01.htm. 2011] compensation for pharmaceutical and vaccine injuries 279 system—or any supplementary regulatory regime—is needed as an adjunct regulatory regime. before a drug is introduced into the market, it undergoes a multi-stage approval process. pharmaceutical companies engage in substantial preclinical testing, in the laboratory or with animals, to make preliminary assessments of a new drug’s safety and efficacy. companies submit promising compounds to the fda through an investigational new drug (“ind”) application.7 once an ind is approved, three phases of clinical testing follow.8 phase i testing, typically with healthy volunteers, examines absorption, distribution, metabolism, and excretion to uncover side effects and establish safe dosing limits.9 phase ii targets a small sample of individuals suffering from the targeted disease or ailment in order to make a preliminary determination of efficacy.10 if phases i and ii show general success, and costs in terms of side effects that do not outweigh the benefits expected due to the compound’s efficacy, potential new drugs undergo phase iii testing, which is a randomized, controlled trial of a larger population of suffering or infected individuals.11 if phase iii tests show efficacy at a ninety-five percent confidence interval, companies submit a new drug application (nda) to the fda for approval.12 the fda’s approval process for new drugs is complex, timeconsuming, and expensive. new drug development typically takes a decade to complete and costs close to $1 billion dollars.13 moreover, according to industry estimates, only about one in 10,000 investigated compounds ultimately makes it to the market.14 in assessing the fda’s regulatory process, it is important to understand that regulation inherently entails two types of errors: “type i” errors, in which approved drugs turn out to be unsafe or ineffective; and “type ii” errors, in which reasonably safe and effective drugs are withheld or delayed, to the public’s detriment. the fda’s critics have contended that the agency is much more likely to commit type ii errors than type i errors, 7. see 21 c.f.r. § 312.20. 8. see 21 c.f.r. § 312.21. 9. see 21 c.f.r. § 312.21(a). 10. see 21 c.f.r. § 312.21(b). 11. see 21 c.f.r. § 312.21(c). 12. see generally 21 c.f.r. § 314. 13. health economists estimate a total pre-approval drug development cost of over $800 million for pharmaceuticals generally and over $1 billion for biotechnology products. see joseph a. dimasi et al., the price of innovation: new estimates of drug development costs, 22 j. health & econ. 151, 151-85 (2003); joseph a. dimasi & henry g. grabowski, the cost of biopharmaceutical r&d: is biotech different?, managerial and decision econ. 28, 469-79 (2007). see also benjamin zycher et al., manhattan inst. for pol’y res., the truth about drug innovation: thirty-five summary case histories on private sector contributions to pharmaceutical science (june 2008), available at http://www.manhattan-institute.org/html/mpr_06.htm. 14. see innovation, phrma.org, http://www.phrma.org/innovation (last visited may 1, 2011). 280 indiana health law review [vol. 8:2 due to the high visibility of the latter, and the propensity for the media, public, and congress to react when approved drugs turn out to have serious side effects undiscovered in the approval process. as noted by the late john e. calfee and others in their amicus brief submitted to the supreme court in wyeth v. levine: because the harmful side-effects of the drug may be highly visible, a type i error can and often does lead to impassioned criticism of the agency. on the other hand, a type ii error—the failure to permit marketing of a drug that would in fact provide benefits in excess of harms—is typically known only by the relatively few persons who are intimately involved in developing the drug and are largely hidden from patients and the larger medical community.15 in general, fda regulators face far more incentive to worry about the next thalidomide, fen-phen, or vioxx than about exercising undue caution in delaying or denying new drug approval.16 empirical testing to weigh the prevalence of type i versus type ii errors in fda decision-making is difficult, given that type ii errors essentially involve counterfactuals. the best empirical evidence, however, tends to support the theoretical case that the agency is more likely to err on the side of caution or delay. in 1992, congress passed the prescription drug user fee act (“pdufa”),17 which “allowed the fda to levy user fees [on] firms filing a new drug application or biologic license application, in exchange for guarantees on review times.”18 the pdufa regime has allowed researchers to examine whether accelerated drug approvals have created net benefits or harms, and thus, by proxy to assess the fda’s propensity to commit type i and type ii errors. comparing pre-pdufa and post-pdufa data, researchers have concluded that “by the most plausible measure, [pdufa] 15. see brief of john e. calfee et al. as amici curiae supporting petitioner, wyeth v. levine, 555 u.s. 555 (june 3, 2008) (no. 06-1249), available at http://www.aei.org/doclib/ 20080612_brief0801_topost.pdf. 16. there have, however, been a limited category of cases in which general public alarm has placed substantial pressure on the fda to avoid type ii errors, most notably for aids, which were generally available abroad before being approved in the u.s. see, e.g., kenneth i. kaitin & jeffrey s. brown, a drug lag update, 29 drug info. j. 361, 361-73 (1995). in response, the fda “allowed aids patients (and others) access to promising experimental drugs early in the development process, long before their safety and efficacy had been proved.” fran hawthorne, inside the fda: the business and politics behind the drugs we take and the food we eat 54 (2005). 17. pdufa was renewed in 1997, 2002, and 2007 and is up for renewal in 2012. 18. tomas j. philipson & eric sun, is the food and drug administration safe and effective?, 22 j. econ. persp. 85, 87 (2008). 2011] compensation for pharmaceutical and vaccine injuries 281 did not, in fact, have any effect on drug safety: neither the proportion of drugs eventually withdrawn (two to three percent), nor the speed with which they were withdrawn, changed in any statistically significant way since the law’s passage.”19 moreover, researchers calculated the cost of avoidable deaths for drugs approved and withdrawn under pdufa at 56,000 life-years, as against 180,000 to 310,000 life-years saved through the more rapid introduction of drugs under the act, a benefit far outweighing the cost even under the dubiously conservative assumption that all lifeyears lost were attributable to the pdufa regime.20 in short, there is every reason to suspect that the fda, both in theory and based on the empirical data, is more likely to commit type ii than type i error. thus, any additional regulatory regime that is likely to discourage the introduction of new drugs is also likely to have costs outweighing its benefits, given the type-ii-loaded fda regulatory backdrop. iii. pharmaceutical regulation ii: the tort system state common law tort remedies are, of course, just such a regulatory system. given the fda’s bias toward committing type ii error, the extra layer of review that the tort system provides almost certainly generates a net social welfare loss, rather than, as the product liability regime’s defenders insist, serving as a useful complement to the fda’s regulatory scheme. that said, at least a basic assessment of the tort system as it exists in handling pharmaceutical claims is in order. while the decentralized tort system obviously predates the fda regulatory regime, the modern product liability regime essentially postdates not only the 1938 food, drug, and cosmetic act, but also the 1962 kefauver harris amendment that established the modern fda drug testing process. justice traynor’s strict product-liability doctrine first became the law of california in greenman v. yuba power products in 1963,21 and modern design defect and failure-to-warn product liability doctrine dates to the american law institute’s 1965 second restatement of torts.22 modern product liability litigation for pharmaceuticals thus grew up in the shadow of fda regulation. in contrast to the fda’s regime, the tort system is ex post, involves lay decision-makers, and, by its very nature, avoids the complex costbenefit assessment undertaken by the regulatory body. each of these features is potentially problematic. the ex post feature of tort litigation is extolled by its defenders as a virtue, and indeed, given the high cost of fda 19. see tomas j. philipson et al., how safe is too safe?, 2 milken rev. 38, 44 (2006) (emphasis in original). 20. see id. at 45. 21. see greenman v. yuba power products, inc., 377 p.2d 897 (cal. 1963). 22. see generally restatement (second) of torts § 402a (1965). 282 indiana health law review [vol. 8:2 regulation and its bias toward type ii error, there is a strong theoretical case for ex post punishment rather than ex ante delay in an optimal drugregulatory regime. that said, in practice, the tort system’s ex post feature likely exacerbates hindsight bias—the tendency to infer causation and negligence inappropriately given injury—particularly when a decision-making body of unsophisticated lay jurors is involved, along with the potential for punitive awards.23 moreover, the product liability regime charges civil juries to focus solely on the facts of the cases at hand, without considering the broader societal repercussions. given that all drug compounds have side effects, the jury’s inability to engage in the sort of cost-benefit decision-making undertaken by the fda can lead the civil justice system to reach results that effectively contradict the fda’s own cost-benefit analysis. for example, in wyeth v. levine, the failure-to-warn claim consisted of an attack on a side effect specifically known and contemplated by the fda, listed with a product warning given fda approval.24 in addition to these problematic regulatory features, the modern american tort system has a host of defects in handling modern mass tort claims, including pharmaceutical litigation, which i and others have extensively written about elsewhere.25 the multistate, multijurisdictional nature of the american judicial system, under the now-longstanding choice-of-law 23. juries’ weakness at handling scientific evidence in many product-liability cases is well-documented. see generally peter w. huber & kenneth r. foster, judging science: scientific knowledge and the federal courts (mit press, 1997); peter w. huber, galileo’s revenge: junk science in the courtroom (basic books, 1991). cf. daubert v. merrell dow pharmaceuticals, inc., 509 u.s. 579 (1993). 24. richard a. epstein, the case for field preemption of state laws in drug cases, 103 nw. u. l. rev. colloquy 54, 59 (2008) (noting, “levine presents a situation where the fda gave explicit approval to the exact treatment, notwithstanding the precise side effect mentioned in the original warning. what would count as new information to render that explicit authorization obsolete? the mere occurrence of the identified side effect can’t do it because it was warned of in advance. and in levine the sketchy record reveals no evidence collected after the drug hit the market indicating a higher incidence of this failure (and perhaps others) that might call for a reevaluation of the risk/reward ratio for that procedure.”). 25. see, e.g., copland & howard, supra note 6; james r. copland, tragic solutions: the 9/11 victim compensation fund, historical antecedents, and lessons for tort reform 2-10 (manhattan institute for pol’y research, working paper, 2005), available at http://www.manhattan-institute.org/pdf/clpwp_01-13-05.pdf; manhattan inst. for pol’y res., trial lawyers, inc.: health care; condition critical: the lawsuit industry’s effect on american health (2005), available at http://www.triallawyersinc.com/tlihealthcare.pdf; manhattan inst. for pol’y res., trial lawyers, inc.: asbestos; a report on the asbestos litigation industry (2008), available at http://www.wyliecom.com/tli_asbestos.pdf. see generally walter olson, the litigation explosion: what happened when america unleashed the lawsuit (truman talley books 1991); peter huber, liability: the legal revolution and its consequences (basic books 1988); george l. priest, the invention of enterprise liability: a critical history of the intellectual foundations of modern tort law, 14 j. legal stud. 461 (1985). 2011] compensation for pharmaceutical and vaccine injuries 283 and personal jurisdiction doctrine,26 permits the phenomenon known as “forum shopping,” 27 in which attorneys move mass tort cases into states or jurisdictions with favorable regimes,28 due to plaintiff-leaning legal rules, pro-plaintiff judges,29 pro-plaintiff juries,30 and judicial “innovations” such as consolidations or bouquet trials that substantially increase expected jury awards.31 because of the american rule in which the winners of litigation assume their own costs,32 companies facing mass tort lawsuits face enormous pressures to settle lawsuits, which in turn generates incentives for plaintiffs’ attorneys to recruit dubious claims.33 26. see, e.g., erie railroad co. v. tompkins, 304 u.s. 64 (1938) (eliminating federal common law); international shoe co. v. washington, 326 u.s. 310 (1945) (establishing minimum-business-contacts personal jurisdiction). 27. see, e.g., john h. beisner & jessica davidson miller, manhattan inst. for pol’y res., they’re making a federal case out of it . . . in state court (sept. 2001), available at http://www.manhattan-institute.org/html/cjr_3.htm. 28. former lawyer dickie scruggs, an asbestos attorney who led state litigation against the tobacco companies leading to the multistate master settlement agreement, described such jurisdictions openly to a group of investment researchers: “[w]hat i call the ‘magic jurisdiction,’ . . . [is] where the judiciary is elected with verdict money. the trial lawyers have established relationships with the judges that are elected; they’re state court judges; they’re popul[ists]. they’ve got large populations of voters who are in on the deal, they’re getting their [piece] in many cases. and so, it’s a political force in their jurisdiction, and it’s almost impossible to get a fair trial if you’re a defendant in some of these places. the plaintiff lawyer walks in there and writes the number on the blackboard, and the first juror meets the last one coming out the door with that amount of money. . . . the cases are not won in the courtroom. they’re won on the back roads long before the case goes to trial. any lawyer fresh out of law school can walk in there and win the case, so it doesn’t matter what the evidence or the law is.” richard scruggs, asbestos for lunch, panel discussion at the prudential securities financial research and regulatory conference (may 9, 2002), in industry commentary (prudential securities, inc., n.y., new york), june 11, 2002, at 5. 29. see eric helland & alexander t. tabarrok, the effect of electoral institutions on tort awards, 4 amer. l. econ. rev. 341 (2002) (empirically demonstrating that tort awards against out-of-state defendant corporations are positively correlated with partisan judicial elections). 30. see eric helland & alexander t. tabarrok, race, poverty, and american tort awards: evidence from three data sets, 32 j. legal stud. 27 (2003) (empirically demonstrating that low-income and minority jury pools are associated with higher tort awards). 31. see michelle j. white, asbestos litigation: procedural innovations and forum shopping, 35 j. legal stud. 365, 393 (2006) (empirically demonstrating that forumshopping and consolidated, bifurcated, and bouquet trials are associated with higher tort awards in asbestos cases). 32. for a good review of the american rule as against loser-pays systems in practice, and the incentives generated by each, see marie gryphon, manhattan inst. for pol’y res., greater justice, lower cost: how a “loser pays” rule would improve the american legal system (dec. 2008), available at http://www.manhattaninstitute.org/html/cjr_11.htm. 33. see, e.g., joseph n. gitlin, et al., comparison of ‘b’ readers’ interpretations of chest radiographs for asbestos related changes, 11 acad. radiol. 243 (2004) (finding lung abnormalities associated with asbestos exposure in 4.5 percent of cases, as compared to 95.9 percent identification rates by “b” readers hired by plaintiffs’ attorneys ); alison frankel, the fen-phen follies, amer. law, march 1, 2005, available at http://www.law.com/jsp/article.jsp?id=1109597691121. 284 indiana health law review [vol. 8:2 as a regulator of pharmaceuticals, then, tort litigation leaves much to be desired. particularly given the backdrop of fda regulation, there is little reason to assume that the tort system does much more than serve as mandatory product insurance that increases company costs, which deters innovation and raises consumer prices.34 and in the vaccine context, richard manning’s empirical studies have shown a strong association between the threat of litigation and product price.35 of course, the tort system is not only concerned with its regulatory role of operating to deter corporate misbehavior and create safety incentives. in fact, the tort system has a compensatory role, in which it offers payment to make those adversely affected by drug side effects whole. wholesale preemption of tort litigation by fda regulation would necessarily leave injured parties without their classic tort remedy and, absent an alternative form of compensation, might be subject to an equity or fairness critique. iv. a special administrative system: the vaccine injury compensation program in 1986, congress created just such an administrative regime when it passed the ncvia, which created the vicp.36 the law was a reaction to a wave of lawsuits filed against manufacturers of the diphtheria-pertussistetanus and polio vaccines that had led to the price effects explored by manning and prompted many companies to exit the field of vaccine manufacture altogether.37 jointly administered by the department of health and human services and the department of justice, and under the jurisdiction of the u.s. court 34. see philipson & sun, supra note 18, at 93 (noting, “given that the fda’s mandated level of [product safety] investment is binding, product liability in this case does not have additional deterrence effect beyond the fda’s regulations. however, product liability raises firms’ costs and therefore product prices, since it requires firms to pay damages to consumers, and this increase in price for no corresponding gain in product safety reduces social welfare.” 35. see richard l. manning, changing rules in tort law and the market for childhood vaccines, 37 j. l. econ. 247 (1994) (showing the price of the polio vaccine jumped sevenfold, while that of the diphtheria-pertussis-tetanus (“dpt”) vaccine rose to forty-fold, in comparison to a doubling of price in the overall vaccine market in the 1980s after a surge in litigation involving these two vaccines); see also richard l. manning, products liability and prescription drug prices in canada and the united states, 40 j. l. econ. 203 (1997). 36. national childhood vaccine injury act of 1986, 42 u.s.c. § 300aa-22(b)(1), reads as follows: “no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after october 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” 37. see generally paul a. offit, the cutter incident: how america’s first polio vaccine led to the growing vaccine crisis (yale university press, 2005). 2011] compensation for pharmaceutical and vaccine injuries 285 of federal claims, the vicp is a no-fault system insuring against childhood vaccine injury. injuries listed on a “table” updated by the centers for disease control are automatically covered if the listed injury occurred within a set time frame after taking a vaccine. claimants can recover for non-table injuries, but they bear the burden of proving causation. the program is funded by a seventy-five cent excise tax levied on every administered vaccination in the united states. in general, the vicp must be judged as an unqualified success. from 1990 to 2010, the vicp compensated 2518 claims, for a total award value of $1.96 billion.38 administrative costs are a relatively low eleven percent, with only three percent going to attorneys’ fees.39 the existence of the vicp, and the preemption of tort claims, has not seemed to deter continuing safety innovation in the vaccine market, as companies have expanded and modernized production capabilities, developed new and safer vaccine technologies (such as the safer acellular pertussis vaccine, replacing old wholecell technology), and brought new vaccines to market (including gardasil, the first vaccine proved to prevent cancer in humans, introduced in 2006). v. pharmaceutical economics: putting vaccines in context before we decide if and how the vicp can serve as a template for a broader federal administrative compensation regime, we should assess, in a big picture sense, how the economics of the vaccine market vary from those of broader pharmaceutical market. the supply-side economics of the drug development market are generally similar to that of its vaccine subset, but the vaccine market has unique demand-side characteristics and vaccines generate unique positive externalities, which complicate formation of any administrative compensation regime for the pharmaceutical market in its entirety. a. supply-side factors on the supply side, the manufacture of pharmaceuticals roughly parallels that of the vaccine subset of the pharmaceutical market. drug compounds, whether vaccine or otherwise, have high fixed-costs of manufacture, but low marginal costs of production. for example, pharmaceuticals are inexpensive to produce once researched and developed; however, as already discussed, with testing and regulatory approval considered a part of fixed research and development costs, new drug development costs 38. see national vaccine injury compensation program, hrsa.gov, http://www.hrsa.gov/vaccinecompensation/statistics_report.htm. 39. see detailed information on the vaccine injury compensation program assessment, expectmore.gov, http://www.whitehouse.gov/omb/expectmore/detail/10003807 .2005.html (last updated sept. 6, 2008) (assessing cost breakdown between fiscal years 2001 and 2004). 286 indiana health law review [vol. 8:2 upwards of $1 billion dollars per drug.40 absent the intellectual property protection offered by patents, private new drug development could substantially disappear because new entrants to the market would effectively drive prices down to the marginal cost of production and manufacturers who develop new compounds would be unable to recoup their investments beyond the window of time it would take for competitors to replicate compounds, in addition to the barriers to entry afforded by branding, marketing campaigns, and distribution networks.41 medical devices may not consistently follow this economic model, as the marginal cost of manufacturing at least some devices may be substantial, and reverse engineering and manufacturing complex devices is substantially more difficult than for pharmaceutical compounds. nevertheless, patent protection is still important to the medical-device market due to high research and development costs. b. demand-side factors although vaccines fit generally within the broader pharmaceutical market on the supply side, the vaccine market is distinctive on the demand side. unlike most fda-approved drugs, vaccines target a broad population set, rather than a narrow patient group, and are primarily limited-dose rather than ongoing in usage. such characteristics profoundly affect the economics of vaccine development. the first demand-side characteristic—the size of the population target—mitigates in favor of vaccine development, since high up-front costs can be recouped over a larger sales volume. sales are limited, however, because most vaccines are singleor limited-dosage, with only occasional boosters required. in contrast, blockbuster drugs, like those treating high cholesterol, depression, arthritis, impotence, blood pressure, and diabetes, require ongoing, repeated use. one exception is the influenza vaccine, which must be taken annually to be effective, and consequently, has an estimated market size of $2.8 billion in the seven largest developed economies.42 in general, however, vaccines have a fairly limited market 40. see supra note 13, and accompanying text. 41. see, e.g., frank r. lichtenberg & gautier luflos, manhattan inst. for pol’y res., time release: the effect of patent expiration on u.s. drug prices, marketing, and utilization by the public (oct. 2009), available at http://www.manhattan-institute.org/html/mpr_11.htm. “the pharmaceutical industry is the most research-intensive industry in the world. indeed, drug development remains an expensive and uncertain undertaking in which failure is far more common than success. to encourage investment, exceptionally high risks to companies and investors must be accompanied by the promise of limited monopoly profits.” for a fuller discussion of patent economics, see generally richard j. gilbert & carl shapiro, optimal patent length and breadth, 21 rand j. of econ. 106 (spring 1990); see also françois lévêque & yann ménière, the economics of patents and copyright (berkeley electronic press 2004), available at http://www.bepress.com/cgi/viewcontent.cgi?article=1001&context=leveque. 42. see hedwig kresse & holger rovini, influenza vaccine market dynamics, 8 nature reviews drug discovery 841-42 (nov. 2009). 2011] compensation for pharmaceutical and vaccine injuries 287 size, which makes vaccine development very sensitive to litigation and other supply-side shocks. c. externalities certainly the most distinctive aspect of the vaccine market lies in vaccines positive externalities, for example, the fact that a vaccination benefits not only the vaccinated individual, but also society at large. in assessing how externalities affect the vaccine market, it is useful to categorize pharmaceuticals across two dimensions: (1) is the treatment for an infectious agent?; and (2) is the treatment ex ante or ex post? in general, only those pharmaceuticals that target infectious agents generate positive externalities. the cost of pharmaceuticals designed to treat or prevent ailments such as cancer, heart attack, stroke, arthritis, depression, or impotence is largely internalized to the individual taking the medication, save for public financing concerns. vaccines are unique among pharmaceuticals targeting infectious agents because vaccines are preventive rather than remedial. thus, vaccines pose a significant free-rider problem that does not exist for other infectious-agent-targeting drugs. for example, while an individual already infected with a dangerous strain of virus or bacteria has a powerful incentive to take a drug attacking that agent, notwithstanding the positive externalities generated by warding off social infection, the already-healthy individual may decide not to risk potentially dangerous side effects caused by a vaccine, and instead take a “free ride” on others’ decisions to vaccinate. and indeed, the greater the percentage of the population that is vaccinated, the lower the potential costs from such free-riding behavior becomes. if an insufficient percentage of the population is vaccinated, however, both vaccinated and unvaccinated individuals are endangered. a decline in a population’s vaccinated, also stated as reducing a population’s “herd immunity,” can lead to potential outbreaks of disease, even those previously effectively vanquished, as has happened of late with the whopping cough due to dropping vaccination rates among those worried about the side effects of the dpt vaccine.43 vi. administrative compensation for pharmaceuticals and medical devices the peculiarities of the vaccine market justify its special administrative program. the powerful effects of herd immunity and the public health 43. see james r. copland & paul howard, the whooping cough’s unnecessary return, city j. online, feb. 2, 2011, http://www.city-journal.org/2011/eon0202phjc.html. 288 indiana health law review [vol. 8:2 imperative of encouraging universal vaccination, rather than the free-riding otherwise endemic in this market, make a special carve-out for vaccines particularly defensible. moreover, the fact that most vaccines are singleor limited-dose administrations makes the economics of vaccines particularly sensitive to tort litigation or other stressors. in addition, the peculiarities of the vaccine market also serve as a cautionary tale for any attempt to extend the vicp to pharmaceuticals and medical devices. a no-fault system for vaccines makes sense: the approach lowers administrative costs, and linking severe side effects to vaccines is somewhat intuitive, since vaccines are given to individuals who are generally healthy. moreover, to the extent that the vicp overcompensates, it largely operates to encourage vaccination, which has positive societal spillover effects. with the broader pharmaceutical market, however, a no-fault approach may not be workable. to start, the risk of overcompensation is far greater, since non-vaccine pharmaceuticals are given to individuals who are already unhealthy, and tend to skew toward old age, rather than infancy, which substantially complicates questions of causation. moreover, the fda often knowingly accepts side effects with the knowledge that they are outweighed by a drug’s expected benefits. in contrast to the positive herd immunity generated by encouraging vaccination, the benefits of other pharmaceuticals are already largely internalized to the patient, and in many cases passed on to the public through social safety net financing programs. given these considerations, my colleague paul howard and i have proposed an administrative compensation system for all pharmaceuticals modeled loosely on the vicp but different in several salient respects. we believe that the following features are essential to the success of such a program:44 a. field preemption of pharmaceutical claims, with limited carve-outs the challenge brought to the vicp in bruesewitz, and the narrowness of conflictand obstacle-preemption under levine, highlights the importance of adopting a broad preemption doctrine. if individual cases could be brought with particular claims alleging a lack of conflict with an fda decision, an administrative remedy could serve as an additional cost on drug development, thus exacerbating the already-significant type ii bias in the drug-regulatory system. individuals would retain the right to sue health care providers for malpractice if they prescribed a contraindicated drug, or if they improperly administer a drug or device, the medical errors really at the heart of the riegel and levine litigation. individuals would 44. for a fuller discussion of our proposal, see copland & howard, supra note 6. 2011] compensation for pharmaceutical and vaccine injuries 289 not, however, be able to file “fraud on the fda” suits, which would still be proscribed by the supreme court’s decision in buckman.45 b. limitation of most claims to unforeseen adverse events unlike for vaccines, individuals injured by a known side effect, considered by the fda with labeling approval, should not be compensated by any administrative compensation system for pharmaceuticals, unless the medication in question is deemed essential in targeting an epidemic or another serious outbreak of a highly serious, communicable disease. such a limitation recognizes that individuals, through learned intermediaries, internalize the risks and benefits of medications taken in reaction to alreadyexisting ailments. in addition, this limitation encourages safety by encouraging manufacturers to disclose adverse events, to take advantage of the regulatory shield. c. clearly defined causation and injury requirements given the difficulties associated with determining causation and injury, no-fault compensation should be limited to cases in which expected overcompensation is less costly than administrative savings. in the general case, adverse outcomes should be tabled—as with the vicp—but individuals should have to prove causation, with administrative decision makers weighing relative risk factors according to pre-specified criteria. payouts should also be tabled by category of injury, for consistency and predictability. d. independent post-market drug monitoring one clear advantage of moving from a decentralized tort system to a central administrative system is the potential to improve safety through careful consideration of post-market adverse-event data, based on claims submissions, sophisticated data mining, and quantitative analysis. adequate firewalls should separate post-market review from the fda’s drug approval team to avoid potential conflicts. e. system funding while a simple tax system analogous to the vicp’s makes sense at the outset, system funding could be risk-adjusted over time based on the compensation system’s payouts. such an approach would generate clear incentives for manufacturers to invest in safety innovation, testing, and 45. see buckman co. v. plaintiffs’ legal comm., 531 u.s. 341 (2001). 290 indiana health law review [vol. 8:2 disclosure, given the program’s refusal to grant awards for injuries related to already-known side effects. vii. conclusion on its own, the federal regulatory system, as implemented by the fda, costs far more lives by delaying and denying new drug entry and by increasing the costs of drug development, than it saves by preventing drugs with unknown, harmful side effects from entering the market. the concurrent state tort law system is an overlapping regulatory regime that exacerbates this tendency, complicated by a host of features that reduce rather than promote public health and safety. the federal government’s demonstrated success in administering a compensation program for vaccines should serve as a useful template for a broader system to be applied to all medical products, alongside a full field preemption of state common law tort claims for fda-regulated drugs and devices. though differences between the vaccine market and the broader medical markets complicate the structure of such a program, these obstacles are not insurmountable, and an administrative compensation system could facilitate innovation, safety, post-market testing, and disclosure relative to the status quo. state innovation in health care: congress' broad spending power under a national health care system will stifle state laboratories of democracy a government that is big enough to give you all you want is big enough to take it all away. -barry m goldwater tammy murray• i. introduction the supreme court's recent decisions in united states v. lopez1 and united states v. morrisonl articulate a vision of federalism which severely limits congress' regulatory authority under the commerce clause in favor of state or local control of traditional areas of state concern. the court's decisions coincide with ballot initiatives that show the states still desire to maintain control over many aspects of healthcare; medicinal marijuana, physician-assisted suicide, and embryonic stem cell research are a few prominent examples. while some of these issues face challenges under federal law, congress' authority to regulate intrastate activities based on a tenuous connection to commerce is no longer a foregone conclusion. still, the spending power of the federal government is nearly limitless, allowing it to influence or control state government regulation of health care. a national health care system will stifle the states' ability to experiment with health care issues and reform. ultimately, the states' ability to function as laboratories of democracy in search of solutions or in experiniental areas that lack a national consensus will be lost if a national health care plan is implemented without imposing limitations on the broad congressional spending power. * j.d. candidate, 2006, indiana university school of law indianapolis; m.b.a., 2001, b.s., 1994, university ofmissouri -columbia. recipient of the indiana bar association distinguished writing a ward 2005. i would like to thank j. brad kallmyer and lakshmi reddy for their guidance in writing this note. in addition, i would like to thank my husband, robert, and my children, adrian, chelsea and todd for their love, patience and understanding as i pursue my legal education. lastly, i would like to thank my feuow classmate and :friend, alexis sumner, for helping me maintain my sanity during law school 1. united states v. lopez, 514 u.s. 549, 567-68 (1995) (invalidating a firearms possession act that neither regulated a commercial activity nor contained a requirement that the possession be connected in any way to interstate commerce, exceeding the authority of the commerce clause). 2. united states v. morrison, 529 u.s. 598,626-27 (2000) (striking down a federal civil remedy for the victims of gender-motivated violence because congress lacked constitutional authority). 264 indiana realm law review [vol. 3:263 health care reform is a hot topic for political platforms, perhaps second only to the war on terrorism in 2004.3 escalating costs in health care and increasing numbers of uninsured persons in the united states are strong incentives for health care reform, and the debate over how to address the health care crisis has led to a political stalemate. therefore, the status quo has been the least risky political option for the decision makers in washington. both president clinton and 2004 presidential candidate john kerry proposed creating a national health care plan offering universal health care coverage. president clinton's plan, however, did not garner support in congress and kerry failed to sway the american people. reluctance of voters to allow the federal government to expand its role in health care regulation can be justified on many grounds. the federal government may impose uniformity at the cost of overutilization of a scarce resource, raising the tax burden. people fear rationing at the cost of human lives. citizens of states that have or are seeking to develop successful health programs fear federal preemption of their efforts and disregard for their values. ultimately, there is apprehension that federal uniformity will· be achieved not only with a high economic cost, but also the cost of state and personal autonomy that may never be recovered. over the last twenty years, the idea of federalism and the state's ability to better serve its citizens' interests has been revived after a dormant phase following the new deal.4 policymakers are reassessing the idea that national problems require control and resolution by the federal government.' in the absence of adequate federal government solutions, several states have emerged as experimental laboratories for important health care issues. 6 a national health care system is certainly not ripe for implementation. it would impede the important laboratories of democracy function of the states, which have historically been granted the power to regulate health care.7 further, realistic limitations on congress' spending power are needed to avoid coercion to comply with a federal monopoly on health care at the expense of state innovation. this note explores the legislature's current regulation of health care under the medicare program and how a national health care plan would affect the states' ability to serve as laboratories of democracy or to experiment with their own health care solutions. part n demonstrates how state experimenta3. kaiser family foundation, health care and the 2004 elections (sept 27, 2004), available at http://www.kff.org/kaiserpolls/7167.cfin. 4. steven g. cal.abresi, federalism and the rehnquist court: a normative defense, 574 annals 24, 25 (2001 ). 5. jeffrey modisett, symposium, discovering the impact of the "new federalism" on state policy makers: a state attorney general's perspective, 321nd. l. rev. 141, 141 (1998). 6. see discussion infra part ll.b. 7. kevinoutterson,healthcare, technologyandfederalism, 103 w.va.l.rev.503, 504(2001). 2006] state innovation in heal1h care 265 tion has led to national solutions, how state and federal governments learn from each other's failed programs, and how state autonomy allows flexibility to meet the needs of a state's electorate. part ill explains the importance of federalism and the supreme court's recent decisions limiting the commerce clause and upholding the tenth and eleventh amendments. part iv reviews the current state of health care in the united states, the need for health care reform, and the jx!litical pressure for a national health care system. part v traces the federal government's regulation of health ca.re under the medicare program and · its use of the congressional spending power to induce cooperation with federal policy that entails more than providing health insurance to the elderly. part vi examines the federal government's ability to regulate participants in a national health care plan that would have the effect of coercing federal compliance to participate in the united states health care system. under the current spending power limitations, this coercion may be unconstitutional. if it is not a constitutional violation, states will lose the ability to serve as laboratories of democracy or to regulate an area that has traditionally been reserved as a state power under the constitution. ll. states as laboratories of democracy a. brandeis' dissent political judgments about particular health care reform requirements are products of personal experience, political beliefs, and local economic and social conditions. these factors change substantially from one region of the united states to another. to be acceptable and tailored to individual citizen's needs, health care reform and experimentation must take account of the real differences between new york and california, indiana and arizona. it is specifically in this context that federalism can play a crucial role in making real medical reform and state experimentation feasible, successful, and acceptable to most citizens. the argument for state experimentation was given its most famous expressions in opinions by justices holmes and brandeis. brandeis' articulate argument in new state ice co. v. l.iebmann8 has become part of the federalist phrase: "it is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country."9 a decade earlier, holmes set the stage for this argument by praising federalism for allowing states to be ''insulated chambers" in which legislative experimentation could be undertaken with little danger to other 8. new state ice co. v. liebmann, 285 u.s. 262 (1932). 9. /d. at 311 (brandeis, j., dissenting). 266 indiana health law review [vol. 3:263 states or the nation.10 in essence, the laboratory of democracy theory supports the idea that states should be able to test their own solutions to problems observed in their constituencies and diverge from national solutions that prove ineffective.11 perhaps the court's recent decisions in favor of constitutionally supported state authority will be a return to justice brandeis' vision of fifty independent laboratories yielding their best results for the nation. 12 this proposition is true especially in areas of diverse solutions, where states may implement legislation that likely never will obtain national consensus. b. cu"ent state experimentation in health care several states in the absence of national solutions have been innovators in health care litigation and financing reform as well as morally controversial areas that lack a national consensus. state'experimentation, both successes and failures, is the key to justices holmes and brandeis' theory of state laboratories. 1. medicinal marijuana the voters of california, through the state's initiative process, passed the compassionate use act of 199613 to ensure that seriously ill californians have the "right to obtain and use marijuana for medical purposes,"14 that "patients and their primary caregivers who obtain and use marijuana for medical pwposes . . . are not subject to criminal prosecution/'15 and ''to encourage the federal and state governments to implement a plan to provide for the safe and affordable distribution of marijuana to all patients in medical need ofmarijuana."16 california's law is in direct conflict with-federal laws, which classify marijuana as a schedule i controlled substance, making the use and distribution illegal.17 had voter mandates legalizing medicinal marijuana been enacted in only a few states, federal enforcement strategies such as suspending a health care 10. truax v. corrigan, 257 u.s. 312,344 (1921) (holmes, j., dissenting). 11. alistair e. newbern. comment, good cop, bad cop: federal prosecution ofstate­ legalized medical marijuana use after united states v. lopez, 88 cal. l. rev. 1575, 1626 (2000). 12. /d. at 1627. 13. cal. health& safety code§ 11362.5 (west 2005). 14. id § 11362.5(b)(1)(a). 15. /d § 11362.5(b)(1)(b). 16. ld. § 11362.5(b)(l)(c). 17. 21 u.s.c. § 812(2005)scheduleldrugsbave"(b) .•. nocurrentlyacceptedmedical use in treatment ... " and "(c) [t]here is a lack of accepted safety for use of the drug . . • under medical supervision." id § 812 (b)(1)(b) and (c) (2005). 2006] state innovation in health care 267 provider's license and prohibiting participation in medicare or medicaid programs might well have suppressed state initiatives.18 since the mid­ nineties, however, eleven states and two localities19 have passed medical marijuana laws similar to california's and have in some way lessened or eliminated state criminal penalties for possessing medicinal marijuana. 20 the united states court of appeals for the ninth circuit has ruled that states are free to adopt medicinal marijuana laws so long as itis not sold, transported across state lines or used for nonmedicinal purposes.21 this ruling only applies to the western states in the ninth circuit's jurisdiction and has been appealed to the supreme court.22 on november 29,2004, the united states supreme court heard oral arguments in ashcroft v. raic~3 and reversed the ninth circuit and held that wholly intrastate, non-commercial cultivation, possession, and use of marijuana in accordance with state law does not place a person beyond the reach of the federal government under the controlled substance act. 2. physician-assisted suicide voters of oregon legalized physician-assisted suicide ( .. pas") in 1994.24 the oregon death with dignity act allows terminally ill oregon residents to obtain prescriptions for self-administered, lethal medications from their physicians and pharmacists. 25 the act permits pas, but specifically prohibits euthanasia or the direct administration of a medication by a physician to end a person's life.26 on november 6, 2001, however, united states attorney general john ashcroft issued a directive which reinterpreted the controlled substances act 18. see discussion infra part vi. 19. angie wagner, how the west was won over: with montana vote, nearly three­ fourths of the west now covered by medical marijuana laws, assoc. press, nov. 11, 2004. after the 2004 elections, most states supporting medicinal marijuana are in the west: montana, alaska, california, colorado, hawaii, nevada, oregon, washington and arizona. states outside the west include maine and vermont and local measures have passed in columbia, missouri and ann arbor, michigan. /d. 20. newbern, supra note 11, at 1577. 21. raich v. ashcroft, 352 f.3d 1222, 1234-35 (2003) (holding that the controlled substance act was an unconstitutional exercise of congressional commerce power when applied to citizens who use marijuana that has not traveled interstate and was never intended for interstate or foreign commerce). 22. !d. 23. ashcroft v. raich 03-1454, u.s. supreme court oral arguments (nov. 29, 2004), available athttp://www.supremecourtus.gov/oral_ arguments/argument_ transcripts/03-1454.pdf. gonzales v. raich, 545 u.s. 1, 16 (2005). 24. oregon death with dignity act, or. rev. stat.§ 127.800-127.995 (2003). 25. id. § 127.805 (2003). 26. /d. § 127.880 (2003). see also lindsay r. kandra, comment, questioning the foundation of attorney general ashcroft's attempt to invalidate oregon's death with dignity act, 81 or. l. rev. 505,509 {2002). 268 indiana health law review [vol. 3:263 as to invalidate oregon's death with dignity act. 27 the directive stated that prescriptions issued for the purpose of assisting suicide were not a "legitimate medical purpose" and the use of a controlled substance to assist in suicide is per se illegitimate. 28 "this was the first time in history that the controlled substances act was used to preempt state law."29 ashcroft's directive threatens physicians with suspension of their medical licenses and possible criminal prosecution, even when they proceed in accordance with the act.30 this invalidation of the oregon act through the federal prosecution of physicians is a clear interference with traditional state government powers: to regulate public health and medicallicensing.31 moral decisions such as the legality ofpas are profoundly personal and should be made as close to the voters as practical. 32 voters have greater . influence and more opportunity to participate in policy decisions at the local or state level than at the national level and therefore, the state's electorate should detennine for themselves whether pas is appropriate policy.33 ashcroft's directive was held invalid at the district courf4 and appellate court levels based on federalism principles. 35 as a rationale supporting state sovereignty, the supreme court stated "[t]hroughout the nation, americans are engaged in an earnest and profound debate about the morality, legality, 27. dispensing of controlled substances to assist suicide. 66 fed. reo. 56,607 (nov. 9, 2001) (codified at 21 c.f.r. pt. 1306). 28. /d seememorandumfromjobnashcroft.attorneygeneraltoasahutchinson,drug enforcement administrator (nov. 6, 2001)(on file with indiana health law review)( stating assisting suicide is not a "legitimate medical purpose" within the meaning of 21 c.f.r. §1306.04 (2001), and that prescribing, dispensing, or administering federally controlled substances to assist suicide violates the csa). 29. kandra, supra note 26, at 505-506. 30. dispensing of controlled substances to assist suicide, 66 fed. reg. 56,607 (nov. 9, 2001)(codifiedat21 c.f.r.pt. 1306). 31. kandra, supra note 26, at 505-506. 32. see discussion infra part ill.a. 33. cbristin a. batt, comment: the pain relief promotion act of 1999 and physician­ assisted suicide: a call for congressional self-restraint, 38 san dmoo l. rev. 297, 325-27 (2001). 34. oregon v. ashcroft. 192 f. supp. 2d 1077, 1092-93 (d. or. 2002). 35. oregon v. ashcroft, 368 f.3d 1118, 1131 (9th cir. 2004). "the principle that state governments bear the primary responsibility for evaluating physician assisted suicide follows from our concept of federalism, which requires that state lawmakers, not the federal government, are 'the primary regulators of professional [medical] conduct.'" (quoting conant v. walters, 309 f.3d 629, 639 (9th cir. 2002)); see also washington v. glucksberg, 521 u.s. 702, 737 (1997)(0'connor, j., concurring). the supreme court has made the constitutional principle clear: "'bviously, direct control of medical practice in the states is beyond the power of the federal government." linderv. united states, 268 u.s. 5 (citation omitted) (1925); see also barsky v. bd. ofregents, 347 u.s. 442 (citation omitted) (1954) ("it is elemental that a state has broad power to establish and enforce standards of conduct within its borders relative to the health of everyone there. it is a vital part of a state's police power."). the attorney general ''may not ... regulate [the doctor-patient] relationship to advance federal policy." conant, 309 f.3d at 647 (kozinski, j., concurring). /d. at 1124. 2006] statelnnovationinhealthcare 269 and practicality of physician-assisted suicide" and"[ o ]ur holding permits this debate to continue, as it should in a democratic society."36 this debate may not end with national consensus; however, state autonomy to experiment with and permit pas should not be stifled by the federal government. 3. embryonic stem cell research the national debate over the use of embryos for stem cell research has resulted in private entities conducting research without government guidelines or regulation. in 2004, californians voted with a fifty-nine percent majority to borrow $3 billion to fund stem cell research over the next ten years. 37 california is targeting research areas such as new lines of embryonic stem cells ("esc") where federal money is not available. 38 "funding from the california stem cell research and cures initiative, which may total as much as $350 million per year, could dwarf other expenditures on esc."39 the national institutes of health spent less than $25 million on this type research in 2003, although it expended more than $380 million on adult stem cell research. 40 the pledge of new money might entice stem cell researchers to california and the strong public support of the research "certainly helps the field overall.'>41 further, the competition may stimulate increased funding by other states. for example, new jersey allocated $6.5 million for a new stem cell institute in may 2004.42 embryonic stem cell research is a very controversial area in which a national consensus to spend federal tax dollars may never be achieved. california's initiative to experiment in this area is precisely defined by "a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.'>43 learning from the benefits and detriments of this experiment in california may lead to a national solution to the debate. 4. partial-birth abortion another area of controversy is the legality and morality of a specific abortion procedure. president bush signed the partial-birth abortion ban 36. washington v. glucksberg, 521 u.s. 702,735 (1997). 37. don monroe, califomia bets big on stem cell research (nov. 4, 2004), at http://www.sciam.com/article.cfin?articleid=oooc585b-3a47 -1189-ba4783414b7foooo. 38. /d. 39. /d. 40./d. 41. /d. (citing the co-director for the harvard stem cell institute). 42./d. 43. new state ice co., 285 u.s. at 311 (brandeis, j., dissenting). 270 indiana health law review [vol. 3:263 act44 ("pbaba") into law in 2003; it is a federal ban on partial-birth abortions except when necessary to save the life of the mother.45 specifically, § 153l(a) of pbaba provides: "[a]ny physician who, in or affecting interstate or foreign commerce, knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both. •>46 many states had implemented bans on partial-birth abortion prior to the enactment of the federal ban.47 a nebraska statute, however, was found unconstitutional under a substantive due process challenge because the law lacked any exception "for the preservation of the ... health of the mother" and it "imposes an undue burden on a woman's ability" to choose the method of abortion, thereby burdening the right to choose abortion itself.48 federal judges have predicted that the federal ban is likely to be unconstitutional because it contradicts the supreme court ruling that struck down the nebraska statute.49 in the court's words, although in a different context, ''the field of health care [is] a subject of traditional state regulation •••• " 50 the federal government may regulate economic activity within health care, but the noneconomic aspects of medicine may be off limits because of the tradition of state regulation in this domain and the lack of any real national interest.51 subject only to the fourteenth amendment, the regulation of abortions has been the exclusive territory of the states before and after roe v. wade. 52 congress uses its spending power to impose limits on the federal 44. partial-birth abortion ban act, 18 u.s.c. § 1531 (2005). the term 'partial-birth abortion' means an abortion in which the person performing the abortion (a) deliberately and intentionally vaginally delivers a living fetus until, in the case of a head-first presentation, the entire fetal head is outside the body of the mother, or, in the case of a breech presentation, any part of the fetal trunk past the navel is outside the body of the mother, for the purpose of performing an overt act that the.person knows will kill the partially delivered living fetus; and (b) performs the overt act, other than completion of delivery, that kills the partially delivered living fetus ... !d.§ 1531(b)(1) (2005). 45. allan ides, the partial-birth abortion act of 2003 and the commerce clause, 20 const. comment. 441,441 (2003-2004). 46. partial-birth abortion ban act, 18 u.s. c. §153l(a) (2005). 47. national right to life committee inc., states that passed legislation outlawing partial-birth abortion (mar. 25, 2004), available at http://www.atr.org/speciallmaps/data/ abortion _legislation. pdf. 48. stenberg v. carhart, 530 u.s. 914, 929-30 (2000) (quoting planned parenthood of southeastern pa. v. casey, 505 u.s. 833, 874, 879 (1992)). 49. howard mintz, federal judges in new york, san francisco halt abortion ban, seattle times, nov. 7, 2003, available at http://seattletimes.nwsource.com/html/ nationworld/200 1785268 _ abort07 .html. 50. pegram v. herdrich, 530 u.s. 211, 237 (2000). 51. ides, supra note 45, at454. 52. /d. 2006] state innovation in health care 271 funding of abortions, but the actual regulation of abortions remains a state freedom. 53 under lopez and morrison, the presumption of unconstitutionality established by the noneconomic nature of the activity is further strengthened by the traditional role of the states in regulating crime and health care, and by the weakness of the argument that partial-birth abortions substantially affect interstate commerce. 54 even if the court finds the federal ban on partial-birth abortion unconstitutional under the commerce clause, a national health care plan will allow congress to control providers by exercising its spending power. 55 5. health care financing and medical malpractice reform laboratories of democracy are operating to meet states' economic concerns in providing for the health of their citizens. states have a large stake in health care reform; in 1999, twenty-seven percent of total state budgets were consumed by health care services. 56 in the 1980's when comprehensive health care reform dropped off the federal radar screen, states were left to develop solutions to their citizens' health care needs. s7 in addition, federal spending decreased and existing programs were used by the federal government to force participation in programs by insuring new groups. 58 these unfunded mandates and the federal government's increased state flexibility in offering medicaid and medicare waivers demanded greater state involvement in health care financing. at the same time, the cost of care continues to increase and health care providers' reimbursement rates are decreasing; some providers are closing their practices to federal entitlement recipients such as medicare patients. 59 while this outcome is contrary to the intended goal of the medicare program, the impact does not stop there because "[m]ost of the nation's private health insurance companies benchmark their fee schedules to the medicare physician 53. /d. 54. /d. at461-62. 55. see discussion irifra part vi.b. 56. federausm & health poucy 60 (john holahan et al. eds., 2003). 57. robert f. rich & william d. white, symposium: federalism and health care policy, 1998 u.iil. l. rev. 861,874-75 (1998). 58. id (stating under medicaid, states were offered the option of either covering new groups or pulling out of the program entirely). 59. william f. jessee, statement of the medical group mgmt. assoc. to the practicing physician's advisory group: 2004 medicare physician fee schedule (feb. 10, 2003), avail­ ableathttp:llwww.cms.hhs.gov/facalppacloral_mgma.pdi medicarephysicianreimbursement fees deceased in 2003 by 4.4%. /d. 272 indiana heal til law review [vol. 3:263 fee schedule.'>60 therefore, reimbursement rates decrease across the private market as well. in the absence of federal solutions to the health care crisis and unfunded mandates to states by the federal government to retain participation in federal programs, states have become innovators in health care financing. several states have undertaken comprehensive health care financing reform in diverse ways. while they have had varying degrees of success and can provide examples for other state reform, many of the states that abandoned universal coverage cite federal roadblocks to reform as the cause.61 hawaii is perhaps the best known success story; it provides health care coverage for between ninety·five and ninety.eight percent of its adult population through an extraordinary combination of reform strategies.62 other reform examples include maryland's regulation ofhospital rates, which is the most developed and successful in the country, and new york's rate of growth in hospital spending, which is among the lowest.63 the states' familiarity with local health care delivery requires that they be the innovators of health care reform across the nation. ..states have implemented programs mandating employers to provide health insurance to their employees, rationing medical services to the poor, enlarging purchasing pools, expanding medicaid to cover all uninsured residents at or below the federal poverty level, and providing improved benefits packages for children, among other reforms. "64 successes in some states lay the foundation for further health care reform in other states. 6s 60. jd medicare bas unfairly included prescription drugs as physician services to reduce reimbursement. while providing a different definition to limit ancillary services. jd. 61. see discussion infra partll-c. see also howard m. leichter, state governments and their capacity for health care reform in health poucy, federaijsm, and the american states 172 {robert f. rich & william d. white eds., 1996). 62. jerry l. mashaw & theodore r. marmor, commentary, the case for federalism and health care reform, 28 conn. l. rev. 115, 124-25 (1995) (stating hawaii uses play or pay, monopoly bargaining, voucher-type gap filling and a single-payer regulatory control). 63. jd. 64; scott d. litman, note, health care for the twenty-first century: the need for a federal and state partnership, 7 cornellj. l. &pub. pol'y 871, 880 (1998). 65. id. 2006] state innovation in healm care 273 also, states have been innovators in controlling medical costs associated with managed care, 66 malpractice litigation, 67 and defensive medicine. 68 some states have enacted legislation of medical malpractice caps and set up medical review panels and boards.69 a 2003 study examined state data from 1993 to 2002 and found that a cap on noneconomic damages and a ban on punitive damages enacted together reduced malpractice premiums by more than one­ third. 70 in addition, states without malpractice reform are facing decreased medical access and physician shortages.71 in 1975, indiana was one of the first states to enact comprehensive malpractice reforms.72 indiana's reforms have gained national attention and several states have used these reforms as a model. 73 california's medical malpractice reform also is successful and was 66. centers for medicare & medicaid services, health care industry market update: managed care (mar. 24, 2003), available at http://www.cms.hhs.gov/reports/hcimul hcimu_03242003.pdf [hereinafter cm8-update]. two-thirds of commercially insured americans were in ppo and pos plans, while one-fourth are in hmos. id 67. congressional budget office, economic and budget issue brief: limiting tort liability for medical malpractice (jan. 8, 2004), available at http://www.cbo.gov/ showdoc.cfin?index=4968&sequence=o [hereinafter cbo-economic]. malpractice costs amounted to an estimated $24 billion in 2002, but that represents less than two percent ofhealth care spending. !d. 68. georgemcgovern&alan simpson, we'rereaping what we sue, wai.lst.j.,april 17, 2002, at a20. a bipartisan group stated, "[l]egal fear drives [doctors] to prescribe medicines and order tests, even invasive procedures, that they feel are unnecessary. reputable studies estimate that this 'defensive medicine' squanders $50 billion a year .•.. " id. see also oversight hearing on health care litigation reform: does limitless litigation restrict access to health care? hearings of subcommittee on commercial and administrative law, june 12, 2002, available at http://www.house.gov/judiciarylban061202.htm. (hearing statement of chairman bob barr). practically untouched by the medical liability insurance crisis, californians have enjoyed successful health care litigation reforms for over twenty-five years. id as a result. california's health care delivery is more accessible and cost-effective. id. 69. cbo-economic, supra note 67. 10.id 71. texas medical association, practice management: medical liability and lawsuit abuse: a profession in crisis, available at http://www.texmed.org/liability/professionln crisis.asp (last visited jan. 16, 2005). "more than half of all texas physicians ... are considering early retirement due to [the] medical liability insurance crisis. about 40 percent say they are ... [limiting] the patients they will accept. nearly a third are reducing the types or kinds of services they provide[] and [a]lmost a fourth [are having] ..• difficulties recruiting or retaining physicians in their communities." id see also bob keaveney, physician-friendly state, physician practice (july 2003), available at http://www.merritthawkins.com/ pdf/articles/physician-fiiendlyg.420states.pdf. 72. eleanor kinney, symposium, indiana's medical malpractice reform revisited: a limited constitutional challenge, 311nd. l. rev. 1043, 1046 (1998). indiana malpractice act ofapr.17, 1975,pub.l.no.146-1975, 1975lnd.acts854(codifiedasamendedatind.code §§27-12-1-1 to-18-2(1993)). "theactcontainsthreemajorreforms:(l)acomprehensivecap on damages, (2) mandated medical review before trial, and (3) a state-run patient compensation fund to pay large claims." id. 73. id. there are large discrepancies between state premiums. letter from john c. nelson, president american medical association, to editor of the new york times (mar. 1, 2005),availableathttp://www,ama-assn.org!amalpuhlcategory/14764.html "atypicalob-gyn 274 indiana health. law review [vol. 3:263 the model for the federal health act of 2003, which passed the house and failed in the senate by a margin of forty-nine to forty-eight.74 with further state testing, the likelihood of national comprehensive medical malpractice reform is encouraging. state experimentation in the area of health care financing and medical malpractice reform allows states with similar problems to implement success;. ful programs. it also helps to prevent avoidable failures because states may learn from the mistakes of other states. further, the diverse needs and desires of a state's electorate can be considered and met without putting the entire nation in jeopardy with a uniform solution that may not be the best or even an adequate solution for any one state. c. federal road blocks state innovation and implementation of health care reform has been hampered by congress' unwillingness to restructure the employee retirement income security act ("erisa'')75 preemption and offer medicaid waivers. the major discrepancy between erisa and health care reform stems from state laws that attempt to modify medical insurance plans and federal preemption which prevents significant reform. 76 obstacles do not develop from a state's inability to enact legislation, but rather from the inability to enforce the legislation against large employers. 77 companies that are protected by erisa preemption are not required to comply with state insurance regulations and large companies that offer self­ insured medical plans to their employees have avoided paying state taxes on these benefits by using the preemption. 78 this avoidance further cripples state governments' ability to finance health care reform. congress' decision to support employment law over health care policy requires that state govern­ ments find creative ways to regulate health care while avoiding erisa preemption. 79 this difficulty has hindered important reforms in health care in los angeles, where there is an effective cap on pain and suffering, pays $63,272 for medical liability coverage. that same ob-gyn in miami, where there's no effective cap in place, pays $277,241 a year for the same coverage." id. 74. william p. gunnar, is there an acceptable answer to rising medical malpractice premiums?, 13 .ann. health l. 465, 492 (2004). 15. employee retirement income security act, 29 u.s.c. § ll 08 (2005). 76. angelo a. stio ill, note, state government: the laboratory for national health care reform, 19 seton hall. legis.]. 322, 335 (1994). 77. ld. at 336. 78. ld at 335. 79. litman, supra note 64, at 884. 2006] state innovation in health care 275 and will continue to do so until either congress or the supreme court grant states the erisa exemption required for meaningful change. 80 medicaid waivers also play an important role in permitting states to experiment with different approaches to health care finance, delivery, and challenges of the particular needs of special groups. 81 similar to the problems in obtaining erisa waivers, states have faced obstacles when they attempt to obtain medicaid waivers from congress. 82 since the balanced budget act of 1997, however, states have more flexibility concerning medicaid and greater success has been produced by state experimentation with diverse constituents' needs.83 d. a national solution emerges 1. experimentation without putting the nation at risk innovative state programs represent the core of justice brandeis' words when he wrote of the importance of maintaining the states as laboratories of democracy or the ability to test fifty techniques of dealing with a problem and adopt the most effective as a national solution.84 the nature ofbureaucracy, coupled with the challenge of innovation, supports the notion of state tested solutions, "rather than reinventing the wheel at the federallevel."85 state tobacco litigation provides the best example of state-initiated reform achieving national results. the attorney general of mississippi filed the first state tobacco lawsuit in 1994 based solely on state-law theories. 86 soon after, other states filed similar suits. 87 early in the mississippi litigation, the u.s. department of justice declined to join the tobacco litigation by becoming a party in existing cases or assisting the states in their suits. 88 80. stio, supra note 76, n.57. members of congress believe that employers would be subject to a web of state laws when operating in several states and political factions in each state would hamper employers' ability to efficiently manage benefits.jd 81. eleanor kinney, symposium, current issues in insurance law: rule and policy making for the medicaid program: a challenge to federalism, 51 ohio st. l.j. 855, 873 (1990). 82. fernando r. laguarda. note, federalism myth: states as laboratories ofhealth care reform, 82 geo. l.j. 159, 177-79 (1993). 83. carols. weissert & wd..uamg. weissert, c..overninghealth: dmpoijticsof health poucy 223-226 (2d ed. 2002). 84. see discussion supra part ll.a. 85. david l. markell, states as innovators: it's time for a new look to our "laboratories of democracy" in the effort to improve our approach to environmental regulation, 58 alb. l. rev. 347, 358 (1994). 86. modisett, supra note 5, at 152. 87. id. at n.87. minnesota was the second state to file its suit in august 1994. see minnesota v. philip morris, inc, 551 n.w.2d 490 (minn. 1995). four years later, nebraska becaji1e the forty-second jurisdiction to file suit. modisett, supra note 5, at n.87. 88. id. at 152. 276 indiana health law review [vol. 3:263 ultimately, several states proceeded alone and found themselves working jointly to produce a common result.89 together, state attorney generals proposed settlement terms, conferred with public-health groups, advised governors and state legislators, and developed a plan to distribute settlement proceeds.90 and what did the federal government do? a lien was placed on state proceeds by the department ofhealth and human services before the money could grace states' coiffures 91 on the theory that medicaid claims constituted a part of the states' lawsuits.92 2. past successes and the importance of failures successful state innovation can be found across a spectrum of policy areas. in 1996, congress turned over welfare regulation to the states on the laboratories of democracy theory.93 several state experiments have been successful, especially the wisconsin works workfare program developed by wisconsin governor tommythompson.94 additional examples of successful state-initiated innovation include do-not-call lists for telemarketers, antitrust and child-labor laws, prescription-drug price limits, legal rights for homosexuals, background checks or waiting periods for gun buyers, limits on medical-malpractice claims, and deregulation of electricity.95 also, women's 89. /d. 90. joy johnson wilson, federal affilirs counsel director, health committee national conference of state legislatures (mar. 12, 1999), available at http://academic. udayton.edulhealth/syllabi/tobacco/summary.htm. ''on november 23, 1998 the attorneys general and other representatives of 46 states, puerto rico, the virgin islands, american samoa, the northern mariana islands, guam and the district of columbia signed an agreement with the five largest tobacco manufacturers, ... ending a four year legal battle between the states and the industry ... four states (florida, minnesota, mississippi and texas) had previously settled with tobacco manufacturers for $40 biuion." ld 91. modisett, supra note 5, at 153. 92. jeffery a. modisett, att'ygen. oflnd., univ. of california, san fransisco, prepared testimony of jeffrey a. modisett attorney general of indiana before the house committee on commerce subcommittee on health and environment (dec. 8, 1997), available at http://www.library.ucst:edultobaccollitigatioofm/modtestimony.html?printftiendly=l& (arguing the states expended resources to sue the tobacco industry and medicaid claims constitute little if any part of states' lawsuits). 93. newbern, supra note 11, at 1633. 94. modisett, supra note 5, at 151-52. 95. dennis cauchon, fed-up states defy washington, usa today, dec. 9, 2003, at la. thirty-nine states had "do-not-call lists" fortelemarketers before congress created a federal list, and states had antitrust and child-labor laws before implementation by the federal government. over two dozen states are trying to lower prescription-drug prices. id maine penalizes pharmaceutical companies that refuse to sell drugs to uninsured people at the same discounted price as medicaid pays. variations on maine's law have been enacted in lllinois, hawaii, montana and new mexico. id legal rights for homosexuals have made dramatic advances in the states; new mexico was the fourteenth state to ban workplace discrimination against gays by public and private employers and the massachusetts supreme judicial court ruled that gay 2006] state innovation in health care 277 suffrage in wyoming preceded national suffrages by thirty years.96 putting theories to the test at the state and local government level is not only wise, it is crucial. "[s]trategies borne at these levels will have been battle-tested and are more likely to have been refined and made workable than those hatched far from the front lines. "97 "[d]amage resulting from innovations 'gone awry' is less significant, or at least localized, if the innovations occur at the state level rather than at the federal level .... "98 health care issues are of vast importance and testing through state innovation should be welcomed by the federal government. e. states learning from states each state may exert its independent power as it desires, subject to the supremacy clause. 99 states can choose different methods of regulating common goals, or they may regulate different objectives altogether because unique demographic, cultural, philosophical, or geographic influences will produce varying results. 100 over time, a state will be able to look to other states' approaches and results when implementing or assessing its own systems.101 fu fact, congress is allowing states to experiment with solutions to national problems. for instance, in the last few years, congress has abolished federal welfare entitlement and permitted states to experiment with their own welfare systems. also, the removal of the mandatory federal interstate speed limit allowed state legislatures to pass limits that they consider appropriate.102 fu the area of the environment, the environmental protection agency has given the states more flexibility in enforcing environmental laws. 103 likewise, federal barriers should be removed to permit states to experiment and learn from other states' innovations in health care. 104 couples have a right to marry. !d. twenty-five states had background checks or waiting periods for gun buyers before the federal government required it in 1994. jd. conservatives have enjoyed success too; among them are limits on medical-malpractice claims and deregulation of electricity./d 96. fed. energy regulatory comm'n v. mississippi, 456 u.s. 742, 788 (1982) (o'connor, j., concurring). 97. markell, supra note 85, at 357. 98. jd. at 356-59. 99. modisett, supra note 5, at 151. 100. jd. 101. !d. 102. id at 141. 103. jd. at 145. 104. peggy l. bartels & pris baroniec, badgercare: a case study of the elusive new federalism, health aff. (nov.-dec. 1998), available at http://content.healthaffairs.org/cgi/ reprint/l7/61165.pdf. (raising federal government barrier concerns in seeking medicaretitle xix and chiptitle xxi waivers). badgercare would ensure access for all low-income children and the adults who support them. jd. states should be entrusted with health care reform just as they were allowed to experiment with welfare reform. !d. 278 indiana health law review [vol. 3:263 for example, new york's child health plus (chp) served as a model for the federal state child health insurance program (schip) legislation. 105 the federal legislation allows for flexibility and the states set up plans to meet their individual needs.106 state policymakers had the benefit of observing and learning from other states as they implemented their own program. 107 f. issues that are unique to a state electorate i. health care reform true distinctions in heath care are found throughout the united states. the resolution of health care issues in the east may be vastly different from those in the west. for example, because of their widespread experience with health maintenance organizations (hmos ), californians may be content with managed competition. 108 in contrast, citizens ofvermont may find the notion of competition among large health insurance companies absurd given the small size and population of the state.109 maryland may prefer an all-payer system for cost control because this approach has proven successful in constraining hospital costs; kentucky has a comprehensive statewide insurance that seems to suit its population, while the greatest dilemma in connecticut is cost escalation. 110 therefore, the possibility of meeting varied state goals in health care at the national level is improbable given the diversity of the united states. 2. moral issues "when an issue turns solely on ethics, not science, it is reasonable to allow individual states to reach their own conclusions, rather than impose a uniform national standard through implied preemption of state medical standards."'" the political reality is that a smaller unit of government is likely to have a population with preferences that depart from the majority's and is therefore more inclined to try an approach that could not command 105. william p. brandon et al., launching schip: the states and children's health /nsurance,in'limnewpollticsofstatehealthpoucylsl (robertb.hackey&davida. rochefort eds., 200 i). 106. /d. at 143. 107. see generally id. at 142-185. 108. mashaw & marmor, supra note 62, at 116. 109. id llo. /d. at ll6-l7. ill. joy falleck, note, the pain rltliefpromotionact: wiu it spell "death with dignity" or is it unconstitutional? 21 fordham urb. l.j. 1739, 1753-54 (2000). (quoting letter from robert raben, assistantatt'y general, u.s. dept of justice, o:fi oflegis. atf., to henry hyde, chairman, house comm. on the judiciary (oct. 19, 1999)). 2006] statelnnovationjnhealtiicare 279 national consensus.112 four major and distinct regions of the united states have been identified-the northeast, the midwest, the south and the west--each vote very differently and diverge on matters of religion, culture, and to some extent, race and ethnicity.113 "the south is more religious, more culturally conservative, less catholic, and more racially polarized in its voting behavior than the rest of the country."114 therefore, the west may support policies such as physician-assisted suicide that are opposed by the religious, culturally conservative south. acting on distinct cultural, social and political traditions, states can experiment with new ideas that may influence their neighbors or more importantly, satisfy their own constituents' needs. national solutions can be the majority's moral views in disguise as the necessary uniform answer to a problem. reacting to a call for uniform national standards, representative barney frank stated that: the existence of a right of assisted suicide in oregon has no effect in massachusetts or oklahoma ... but clearly the need for uniformity simply reflects a desire of people here to impose their moral views on the people of oregon who have been found to be morally deficient in this particularregard.115 federalism only has meaning if congress exercises restraint even when it opposes state policy choices. to claim that states should be free to experiment with policy only when their experimentation reflects a national consensus, rather than their population's preferences, is really to assert that the states are merely administrative arms of the federal government.116 issues that create division in cultural or moral belief may gain accep­ tance at the state level and lead to national tolerance and perhaps eventual approval. in the past, diverse state laws and eventually a supreme court decision117 changed state miscegenation laws and today, interracial marriage is common throughout the nation. likewise, same-sex marriage as a constitutional matter is forcefully debated and remains divisive. when an issue divides in ways that cut to the heart of people's identities, the court's best strategy is to leave the matter to state experimentation tis and perhaps a 112. the federalist no. 10 (james madison); see also steven g. calabresi, a government of limited and enumerated powers: in defense of united states v. lopez, 94 mich. l. rev. 752, 761 (1995). 113. calabresi, supra note 112, at 766--67. 114. /d. at 767. 115. falleck.supranote ill, at 1753 (citingh.r.rep.no. 106-378,pt. l,at32 (1999)). 116. /d. at 1753-54. (citing editorial, the assisted suicide ban, wash. post, nov. 1, 1999, ata26). 117. loving v. virginia, 388 u.s. 1 (1967). 118. william n. eskridge, jr., symposium, gay rights after lawrence v. texas: article: lawrence's jurisprudence of tolerance: judicial review to lower the stakes of identity politics, 88 minn. l. rev. 1021, 1092 (2004). 280 indiana healtif law review [vol. 3:263 national solution will emerge. in fact, this is the approach the court took in the right-to-die case, washington v. glucksberg, 119 when it found the nation should continue the crucial debate about the morality and legality of physician-assisted suicide. 120 ill. importance of federalism and recent supreme court decisions supporting a new federalism both in the past and today, the political debate focuses on federalism or the appropriate balance between the federal and state governments regarding health care and the extent the government should be involved at all. 121 to ensure protection of the people's rights, the constitution creates two governments rather than one. therefore, the power is divided between the federal and state governments. the powers of the national government are limited and enumerated and the remaining powers are reserved to the states. 122 over the past 200 years, many factors led to an expansion of national power at the expense of state autonomy and are beyond the scope of this note. still, it is pertinent to examine the benefits of federalism that are lost when power is centralized in the national government. specifically, decentralized government with authority at the state and local level fosters greater political participation, increased accountability, and more innovation to experiment with solutions. a. federalism arguments 1. greater political participation voters have a greater opportunity to influence and participate in decisions that impact their lives at the state level. 123 "the framers recognized that the most effective democracy occurs at local levels of government, where people with firsthand knowledge oflocal problems have more ready access to public officials responsible for dealing with them. this is as true today as it 119. washingtonv.glucksberg,521 u.s. 702, 735(l997)(holdingthatwashington'sban on assisted suicide promoted an important and legitimate government interest and did not offend the fourteenth amendment to the united states constitution). 120. id. at 735. 121. robert f. rich & william d. white, health care policy and the american states: issues of federalism, in healthpol'y,federausm,andtiieam.states 3-4 (robert f. rich & william d. white eds., 1996). 122. see u.s. const. art. i, § 8; u.s. const. amend. x (stating "[t)he powers not delegated to the united states by the constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people."). 123. barry friedman, symposium, the law and economics of federalism: valuing federalism, 82 minn. l. rev. 317, 390-92 ( 1997)( arguing that a smaller electorate brings the government closer to the people). 2006] state innovation in health care 281 was when the constitution was adopted."124 many health care policy choices involve issues in which intelligent citizens hold diverse, but equally rational views that are better represented by state government choices than homogenous national laws. 125 representing the entire nation at the expense of independent state policy choices destroys the political impact each citizen has on health care decisions. many health care choices involve intimate social policy that should be decided by state voters, not by distant and remote members of congress. 2. more government accountability and access a compelling argument for state responsibility for health care is that the constitution contemplates that a state's government will represent and remain accountable to its own citizens. 126 when the federal government asserts authority over a state's most fundamental political processes, it undermines political accountability. generally, state lawmakers live in the same localities as their constituents and are personally impacted by policy choices. further, smaller units of government "makes it far easier for citizens to exercise a greater and more effective degree of control over their government officials"127 through increased access. for this reason, it often makes sense for states to retain control over controversial social issues where government officials may be scrutinized more readily by voters. 128 justice kennedy begins his concurring opinion in lopez by citing the federalist proposition that "two governments accord more liberty than one,"129 and for this to be realized, "citizens must have some means ofknowing which of the two governments to hold accountable for the failure to perform a given function."130 in justice kennedy's view, the role of the court is to protect states from the intrusion of the federal government into areas of state regulation. 131 unless a balance is preserved, "the boundaries between the spheres of federal and state authority would blur and political responsibility would become illusory."132 124. garcia v. san antonio metro. transitauth., 469 u.s. 528,576 n. 18 (1985) (powell, j ., dissenting) (citing the federallst no. 17, 46). 125. grant s. nelson & robert j. pushaw, jr., rethinking the commerce clause: applying first principles to uphold federal commercial regulations but preserve state control over social issues, 85 low a l. rev. 1, 118 ( 1999) (stating thatfederal standards wipe out differences of opinion on social, cultural, or moral issues and that diversity of views should be encouraged, and the only realistic means to do so is through state and local legislation). 126. lopez, 514 u.s. at 576·77 (citing thefederallstno. 51, 46). 127. calabresi, supra note 112, at 778. 128. /d. 129. 514 u.s. at 576 (kennedy, j. concurring)( discussing thefederallstno. 51). 130. id. at 576·77. 131. id. at 576· 78. 132. id. at 577. 282 indiana heal1h law review [vol. 3:263 a unifonnnational solution to health care issues very easily can become a solution that is. not tailored to anyone. furthermore, policymaking at the national level makes it difficult for those communities which suffer from policy errors or oversights to get their concerns addressed. 133 the majority of a state may be a national minority and their political voice can be deafened. health care decisions should be made at the state level because health care policy choices must reflect the consensus of the population and decision­ makers should be accountable. 134 it is easier to achieve consensus on a small scale and in the united states system, the state represents the clearest fonn of community.135 as the nation faces tough decisions in health care, true solutions will not come without the consent of the greatest number of citizens, which is more likely at the state level. 3. state experimentation a closely related argument and the primary focus of this note is that state diversity and experimentation are vital to health care. state and region differences are evident in the current choices concerning medicaid and state laws governing controversial health care issues.136 undeniably, there is diversity in health care and individual states should be allowed to adopt laws and pursue policies that reflect their different preferences.137 beyond mere accommodation of social, political, or cultural differences, state diversity encourages states to experiment with their policies.138 indeed, necessary innovation may present a better picture of the reality of state experimentation because rather than a carefully planned experiment, often state officials are solving real problems staring them in the face. 139 innovation becomes an evolutionary process as state and local governments develop different strategies for solving problems and learn from each other. 140 through observation and communication, techniques employed in other locales are shared and the most attractive solutions can be adopted by other states while the less effective solutions are avoided. 141 just as in any facet of life, better solutions develop as we learn from our mistakes and the experiences of others. 133. jonathan h. adler, comment. thegreenaspectsofprintz: the revival offederalism and its implications for enviromnental law, 6 geo. mason l. rev. 573, 629 (1998). see printz v. united states, 521 u.s. 898 (1997) (stating this concern for political accountability). 134. laguarda, supra note 82, at 190. 135. id. 136. weissert & weissert, supra note 83. 137. harry n. scheiber, dedication: forward: the direct ballot and state constitutionalism, 28 rutgers l. j. 787, 805 (1997). 138. !d. at 804. 139. friedman, supra note 123, at 398. 140. id at 400. 141. id 2006] state innovation in healm care 283 brandeis warned, "[t]o stay experimentation in things social and economic is a grave responsibility. denial of the right to experiment may be fraught with serious consequences to the nation. " 142 as noted earlier, the supreme court called for just this type of continued state-by-state social experimentation in washington v. glucksberg.143 residents of oregon should be permitted to employ physician-assisted suicide to refine its guidelines and monitor its results; and california residents should be allowed to test the policy implications of medicinal marijuana and support embryonic stem cell research while the nation watches from the sidelines. then voters can determine, state by state, the appropriateness of these social policies. 4. health care-area traditional regulated by states it was the deliberate intent of the constitutional framers to entrust the police power or the protection of public health, safety, and morals to the states and the federal government with less sensitive powers like those over interstate commerce. 144 "moral issues ... are best left to the states, precisely as the founders intended"145 and given the variety of views concerning issues of morality, the protection of liberty supports decentralized decisionmakin 146 g. states are self-interested parties as major regulators, payers, and sources of health care; approximately twenty-seven percent of state budgets are spent on health care147 and health-related programs. 148 furthermore, states have traditionally been left to form their own policies regarding the delivery of health care in vital and controversial areas. 149 in lopez, the court stated that if congress were permitted to regulate areas where states have historically been sovereign, then "it is difficult to perceive any limitation on federal power, even in areas such as criminal law enforcement or education .... " 150 this statement supports the court's protection of state sovereignty in traditionally state-regulated areas. "in 142. new state ice co., 285 u.s. at 311 (brandeis. i., dissenting). 143. washington v. g1ucksberg, 521 u.s. 702 (1997). 144. michael w. mcconnell, review, federalism: evaluating the founder's design, 54 u. cm. l. rev. 1484, 1506 (1987)(stating the "dred scott decision, employing the pernicious doctrine of substantive due process to vitiate congress's power to deal with the slavery question, upset the constitutional scheme and thus made civil war unavoidable."). 145. ld. (quoting raoul berger, federausm:thefounders'design(l987)). 146. id. 147. nat'l assoc. of state budget officers, 2003 state expenditure report (oct. 2004), available at http://www.nasbo.org/publications/pdfsi2003expendreport.pdf. in 2003, over twenty-one percent of state budgets went to medicaid expenditures. id 148. federausm & heal 'ill poucy, supra note 56. 149. newbern, supra note 11. 150. lopez, 514 u.s. at 564. 284 indiana healm law review [vol. 3:263 addition to criminal law enforcement and education, health care regulation is an area where states historically have been sovereign."151 b. federalist supreme court decisions 1. the role of the court there is pressure on congress to appear responsive to every highly publicized societal problem and this must be balanced with an inquiry into whether our policies should be determined at the national or locallevel.152 perhaps the court's approach to federal and state conflicts should not be complete deference to congress because state interests are not always sufficiently represented. inadequate state representation in the political process exists when interest group activity overpowers the accountability of congress to the states, as it does in the area of health care. 153 while judicial activism is not a defensible position, as the federal government blurs the lines of accountability and regulates in areas constitutionally reserved to the states, the court must protect state sovereignty. the constitutional or legal foundations for federalism deal primarily with interpreting the tenth and eleventh amendment and the commerce clause. the court's recent decisions in interpreting the commerce clause and its decisions in tenth and eleventh amendment cases154 suggest that the constitution does provide independent state government authority and the court is willing to protect states' rights.155 first, the court has shown its willingness for the first time since 1937 to police the boundary between congressionally enumerated powers regulating commerce and the enforcement of the fourteenth amendment.156 second, the court has enforced a tenth 151. batt, supra note 33, at316(quoting lopez, 514 u.s. at 564). 152. william h. rebnquist. the 1998 year-end report of the federal judiciary (nov .idee. 1998), available at http:!lwww.uscourts.gov/ttbljan99ttb/january1999 .html#e. 153. laguarda,supranote 82, at 190-91 (arguingthatinterestgroup lobbying at the federal level overshadows state interests because states do nothave the money). see new york v. united states, 505 u.s. 144, 188 (1992) (invalidating provisions of a federal law that required states to take title to low-level radioactive waste or to regulate in accordance with congressional restraints). 154. other recent supreme court cases reinforcing federalism include: city ofboerne v. flores, 521 u.s. 507 (1997) (holding that the supreme court, not the congress, determines the scope of congress • enforcement power under the fourteenth amendment); seminole tribe of florida v. florida, 517 u.s. 44 (1996) (holding congress lacks the authority to abrogate states eleventh amendment immunity from liability); cipollone v. liggett group, inc., 505 u.s. 504 (1992) (holding that state police powers will not be superseded by federal law without explicit evidence of congressional intent); gregoryv. ashcroft, 501 u.s. 452 (1991) (upholding state constitution's mandatory retirement age for judges). 155. rich & white, supra note 121, at 8-9. 156. see united states v. morrison, 529 u.s. 598 (2000); city of boerne v. flores, 521 u.s. 507 (1997); united states v. lopez, 514 u.s. 549 (1995). 2006] state innovation in healtii care 285 amendment barrier forbidding congress' commandeering of states. 157 third, the court has created an obstacle to congress' efforts to expose states to private lawsuits by expanded sovereign immunity.158 collectively, these recent cases denote an obvious departure from the court's prior case law; states have not received such court protection from the federal government since before the new deal. 159 2. commerce clause-lopez and mo"ison decisions in 1995, the court's landmark decision in lopez was the first significant limitation on congress' power under the commerce clause in sixty years.160 in 2000, the court's resolve to limit congress' ability to use the commerce clause to regulate areas constitutionally reserved for the states was reaffirmed in united states v. mo"ison. 161 because the commerce clause arguably does not grant congress this authority, it is now rational to question the basis of congress' power to regulate intrastate activities such as medicinal marijuana, partial-birth abortion, embryonic stem cell research, physician-assisted suicide and state reform efforts. 162 lopez and mo"ison generate the principles that serve as the current standard for evaluating congress' commerce clause authority. the court's resolve to maintain a bright-line separation between the jurisdiction of federal and state power is apparent.163 now, a concrete showing that an activity is economic in nature and that it substantially affects interstate commerce is necessary before the federal government can regulate intrastate activity.164 the court found ''we would have to pile inference upon inference in a manner that would bid fair to convert congressional authority under the commerce clause to a general police power of the sort retained by the states."165 the court will no longer defer to congress in providing such proof, and if no more than a tenuous connection can be made, the activity will be left to the states.166 157. see printz v. united states, 521 u.s. 898 (1997); new york v. united states, 505 u.s. 144 (1992). 158. see seminole tribe v. florida. 517 u.s. 44 (1996). 159. calabresi, supra note 4, at 25. 160. newbern, supra note 11, at 1579. 161. morrison, 529 u.s. at 626-27. 162. newbern, supra note 11, at 1579. 163. see united states v. lopez, 514 u.s. 549 (1995). 164. id 165. id at 567. 166. id at 581. 286 indiana health law review [vol. 3:263 3. tenth amendment-new york and printz decisions both, new york v. united states161 and printz v. united states168 place limits on congress' ability to commandeer the states. in new york, the court held that congress could not force states to adopt a plan for the disposal of radioactive waste and to allow such force would be to erroneously "commandeer the legislative processes of the states."169 in printz, the court held that congress could not compel local law enforcement officers to perform background checks as part of the requirements of the brady bill's handgun regulations.170 these decisions indicate a shift in the court's tenth amendment analysis and an invalidation of the federal government's ability to force the states to enact or enforce laws. chief justice rehnquist's reference to this line of precedent in lopez may indicate a larger philoso­ phical shift of the court towards upholding state control over traditional state functions. 171 likewise, the court's decision in gregory v. ashcroft112 indicates that the federal courts have a duty to be certain of congress' intent before allowing federal law to preempt state law and override the balance of state and federal power. otherwise, these acts serve to undermine the state government's accountability and upset the balance between state and federal government.173 4. eleventh amendment-seminole tribe decision another federalism shift occurred on the issue of congress' power to disregard state sovereign immunity under the eleventh amendment. seminole tribe v. florida overruled the court's 1989 pennsylvania v. union gas company174 decision, which stood for the short-lived principle that congress could circumvent the eleventh amendment by using statutes passed under the commerce clause to allow a private citizen to file suit against a state in federal court.175 the eleventh amendment restricts the judicial power under article m, and congress cannot use article i to escape the constitutional limitations placed upon the federal government.176 the court continued to 167. new york v. united states. 505 u.s. 144 (1992). 168. printz v. united states, 521 u.s. 898 (1997}. printz was not under the court's consideration when the lopez decision was opined. 169. new york, 505 u.s. at 161. 170. printz, 521 u.s. at 935. 171. newbern, supra note ll,at 1617-18. 172. gregory v. ashcroft, 501 u.s. 452, 469 (1991) (holding that congress did not demonstrate a clear intent to infringe upon traditional state power to prescribe qualifications for its officers when enacting the age discrimination employment act). 173. new york, 505 u.s. at 168-69. 174. pennsylvania v. union gas company, 491 u.s. i (1989). 175. seminole tribe, 517 u.s. at47. 176. ld. at 72-73. 2006] stateinnovationinhealthcare 287 rely upon the eleventh amendment to limit congressional power over states in other cases and suggested congress allow the states to fashion their own remedies before enacting federal power. m this represents an obvious shift in the court's proclivity to use the commerce clause as a basis for infringing on the states' autonomy. still, state sovereignty is not secure from federal government intrusion because the court's federalist opinions are narrow enough to allow congress to use its spending power to address the same issues. 178 c. strange be4fellows for states' rights-supporting ends rather than means although congress' power has arguably been curtailed, proponents of state initiatives such as medicinal marijuana and pas have not defended these initiatives by pointing out the limits of the commerce clause. instead, these issues are debated almost exclusively in the area of public policy. most likely this is because those who would benefit most from pointing out the potential impact of lopez on these issues are the same parties who support expansive federal power on other issues.179 in fact, these parties would object vigorously to the limitation of the federal government's power in other debates, especially individual rights' cases. 180 lopez has made strange bedfellows in the federalism debate; its impact on a wide range of issues including pas, medicinal marijuana and partial-birth abortion will depend upon the ever­ shifting political climate surrounding these issues. there is political rhetoric, however, on both sides of the aisle and federalism often provides a useful tool for proponents on either side to frame a debate. indeed, federalism often is instrumental when there is a disagree­ ment over basic social or political issues. for example, gun owner and manufacturer advocates espoused state sovereignty arguments to challenge the brady handgun violence prevention act, which required local law enforce177. see newbern, supra note ll,at 1616-17. 178. neal devins, the federalismrights nexus: explaining why senate democrats tolerate rehnquist court decision making but not the rehnquist court, 73 u. colo. l. rev. 1307, 1314-15 (2002). 179. see rory k. little, myths and principles of federalization, 46 ha!mnos l.j. 1029, 1065 (1995) (stating many liberals oppose the federalization of crime because of the severity of federal criminal sentencing guidelines, but are reluctant to support states' rights federalism arguments suggestive of anti-civil rights arguments that were successfidly battled decades ago); david b. kopel & glenn h. reynolds, taking federalism seriously: lopez and the partial­ birth abortion ban act, 30 conn. l. rev. 59, 60 (1997) (discussing a similar political irony faced by those opposed to a federal ban on late-term abortions which might be invalid under lopez, but who are advocates of expansive federal power on other issues). 180. little, supra note 179. 288 indiana healm law review [vol. 3:263 ment officials to conduct criminal background checks on handgun buyers. 181 still, gun owners and manufacturers probably would not support states' rights as vigorously should states begin to enact strict gun control laws. 182 likewise, politically charged health care policy issues force advocates to embrace either state autonomy or federal preemption arguments depending on the nature of the threat. for instance, both pro-choice advocates and federalists may oppose a federal partial-birth abortion ban; the pro-choice advocate because it limits treatment options by physicians and the federalist because the ban preempts areas traditionally reserved to the states-family and health.183 therefore, health care federalism support is often a product of the political ends, which in the long-run is counterproductive to many reforms because the underlying motivation is not at all related to health care solutions. n. current state of healtii care in tile united states a. need for reform so where does all this political rhetoric lead us? depending on the political context, sometimes the united states is said to have a health care crisis. subsequently, the drive for a national health care solution is a result of escalating health care costs and the growing number of uninsured. 1. costofhealth care in 2002, the united states spent $1.6 trillion on health care, an amount more than five times as great in real terms as that spent in 1970.184 as the federal government faces greater pressure to decrease spending, states are left to formulate health care solutions for their citizens.185 today, twenty-seven 181. brian e. bailey, note, federalism: an antidote to congress's separation of powers anxiety and executive order 13,083, 7sind. l.j. 333, 343-44 (2000) (citing pub. l. no. 103159, 107 stat. 1536 (1993) (codified at 18 u.s.c. § 922(s) (1994)). 182. id at 343. 183. ld. at 344. 184. congesssional budget office, cbo testimony on health care spending and the unisured (jan. 28, 2004), available at http://www.cbo.gov/sbowdoc.cftn?index=4989& sequence=o. while the economy as a whole bas grown over that period as well, its growth has been slower; with the result that health spending as a percentage of gross domestic product bas more than doubled, from 7.0% in 1970 to 14.9% in 2002. id federal spending on health care, predominantly medicare and medicaid, is subject to the same cost pressures facing the system as a whole. id total federal health spending as a percentage of gdp was l. 7 in 1970 and 4.8 in 2002. ld. under an optimistic assumption, federal medicare and medicaid spending would reach 11.5% of gdp in 2050. id to put those estimates in perspective, the entire federal budget currently consumes 20% ofgdp. id 185. rich & white, supra note 57, at 875 (stating under medicaid, states were offered the option either of covering new groups or pulling out of the program entirely). 2006] state innovation in heallh care 289 percent of total state budgets are consumed by health care services.186 the escalation of the cost of health care is multi-faceted and beyond the scope of this note. regardless, the over consumption of a scarce resource by consumers and the desire for the most technologically advanced and often the most expensive care is a problem the united states must address. 187 additional factors of managed care, 188 malpractice litigation, 189 and defensive medicine190 also are cited as contributing factors to rising health care costs in the united states. 2. uninsured population it is frequently stated that about forty million americans lack health insurance coverage. while this estimate, by itself, presents an incomplete and potentially misleading picture of the uninsured population, the number of uninsured is a critical factor driving the national debate for health care reform. reality suggests that the uninsured population is constantly changing as people gain and lose coverage. furthermore, people vary greatly in the length of time that they remain uninsured.191 some people are uninsured for long periods of time, but more are uninsured for shorter periods. the congres­ sional budget office's ("cbo") recent analysis found that in 1998 somewhere between twenty-one and thirty-one million people were uninsured all year, forty million people were uninsured at any given point during the year and nearly sixty million people were uninsured at some point during the year.192 even so, health insurance coverage by income shows that twenty percent of those uninsured have incomes over $50,000,193 which may suggest that americans in higher income brackets are opting out of insurance based on their own risk assessment. further, in 2000, sixty-nine percent of uninsured 186. federalism & health policy, supra note 56. 187. mark hall, making medical spending decisions: the law, ethics, and economics of rationing mechanisms, in the law of health care finance and regulation 79 (mark a. hall et al. eels., 2005). 188. cms-update, supra note 66. two-thirds of commercially insured americans were in preferred provider organizations and point of service plans, while one-fourth are in health maintenance organizations. id. 189. cbo-economic, supra note 67. "malpractice costs amounted to an estimated $24 billion in 2002, but that figure represents less than two percent of overall health care spending ... . "!d. 190. mcgovern & simpson, supra note 68. "reputable studies estimate that this •defensive medicine' squanders $50 billion a year .... " ld 191. congressional budget office, cbo testimony: health care spending and the uninsured (jan. 28, 2004), available at http://www.cbo.gov/showdoc.cfm?index=4989& sequence=o (last visited aug. 4, 2005) (based on information obtained in 1998). 192. !d. 193. public agenda, health care: fact file, at http://www.publicagenda.org/ issues/factfiles _ detail.cfm?issue _ type=health care& list= 10 (last visited oct. 31, 2005) (based on us census information obtained in 2003 for 2002 statistics). 290 indiana heal til law review [vol. 3:263 were adults and forty-nine percent were white. 194 while a strong argument can be made that the majority of uninsured are not poor minority children as the political rhetoric suggests, politicians are still motivated to satisfy constituents' perceptions of the crisis. b. political solution-calling for a national health care system 1. political stalemate at the national level today, the united states stands alone as the only industrial nation in the world without universal access to health care.195 perhaps, "[t]his alone suggests that there are factors that make the delivery of health care in the 'u.s. [sic] too complex to administer on a national scale. " 196 conceivably, citizens believe that national uniformity for a diverse country like the united states is not practical or preferable. after all, the united states is a nation that celebrates individualism and diversity. still, the call for universal health care is not a new phenomenon. since the second world war, comprehensive national reform has·. been attempted multiple times, but has not achieved political majorities. 197 while there are particularized factors contributing to previous failures, ultimately our political system has not produced a solution that satisfies enough of the people to surmount the other barriers to health care reform.198 this stalemate is a result of the improbability that any single system is "best" for the whole nation.199 "regions, states, even localities, differ in their demographic characteristics, political cultures, existing styles of medical practice, and appetites for medical services. "200 therefore, what is desirable for any one state varies enough to make state autonomy attractive and politically wise as an alternative to a national solution.201 in support of this proposition, one needs look no further than the independent state initiatives passing medicinal marijuana, pas and stem cell research legislation. several advocates . of cooperative federalism support ending the stalemate by offering a federally funded ''tool box" of options to states to 194. centers for medicare & medicaid services, an overview of the u.s. health care system: two decades of change 1980-2000 (chapter 5), available at http://www.cms.hhs.gov/ charts/healthcaresystem/chapter5.pdf(lasted visited nov. 21, 2004). 195. julia vaugh, what about the uninsured? ethics news, indiana healthcare ethics network. vol. 3. (1999), available at citizens action coalition of indiana, http://www.citact.org/uninsured.htm. "today, the united states stands alone, since south africa enacted a universal health program in 1996." jd. 196. litman, supra note 64, at 875. 197. mashaw & marmor, supra note 62, at 115-116. 198. ld. at iis-116. 199. jd. at ll6-ll7. 200. jd. at ll7. 201. ld. 2006] state innovation in health care 291 reduce the number of uninsured through innovation in health care reform without any strings attached. 202 this partnership would enable the states to undertake innovative approaches to health care challenges facing the nation. in health care as well as education or welfare, states have been the primary innovators and by actually testing competing approaches to reach common goals, rather than endlessly debating them, america is far more likely to find solutions to its health care problems.203 2. voter reluctance to support a national health care plan american voters have not supported a federal health care plan at the ballot box. congress failed to pass universal health care during the clinton presidency and senator kerry's health care reform platform, among other things, failed to sway the american people with his defeat in the 2004 election. "[l]n a nation where only two out of every ten citizens believe that the government 'will do the right thing most of the time"' 204 it is not surprising that the american people are reluctant to allow the federal government to regulate such an important aspect of life. the most serious criticism of the clinton health care reform plan was that it required too much governmental oversight and that such regulation of medicine would result in decreased quality of service. 205 at this point, proceeding with the status quo has been the political solution of choice. a government attempt to provide universal access without careful consideration of the choice and extent of services for those it intends to insure will result in decreased quality, 206 which is something voters have not been willing to sacrifice. v. the medicare example of federalized health care medicare provides the best example of the federal government's ability to regulate a universal health care plan at the national level. therefore, a study of this program is useful to analogize the effect ofa national health care plan. 202. henry j. aaron & stuart butler, how federalism could spur bipartisan action on the uninsured (sept. 19, 2003). available at http://sihp.brandeis.edu/counciljpubs/ health%20insuranceo/o20expansions%202004/aaron%20butler%20september>lo20council %20sept%203%20version.pdf. 203. id 204. litman, supra note 64, at 876. 205. id. 206. judith m. rosenberg & david t. zaring, managing medicaid waivers: section 1115 and state health care reform, 32 harv.j. on legis. 545,547-53 (199s)(statingthatmanaged care waivers were not the intention of 1115 and will lead to a poorer quality of care). see litman, supra note 64, at 876. 292 indiana healtii law review [vol. 3:263 a. the social security act when congress created the medicare program in 1965, its purpose was to provide hospital and medical insurance for persons over the age of sixty­ five, not to accomplish broad societal goals. 207 in fact, congress made clear its intent that medicare funds should not be used for the benefit of non­ medicare patients.208 over time however, congress has expanded medicare to promote broader public goals such as providing indigent care and supporting rural health facilities and graduate medical education.209 medicare expansion often is achieved by using participation in the program as a hook to impose unfunded mandates that apply to non-medicare patients also.210 moreover, the federal government did not expand medicare in a calculated manner to accomplish an identified goal, but rather has been reactionary to a series of largely unrelated matters.211 the irony is that congress itself declared its intention to prohibit federal interference with state medical practices in the preamble to the health insurance for the aged act: medicare. it states: [p ]rohibition against any federal interference. nothing in this title [42 uses §§ 1395 et seq.] shall be construed to authorize any federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided . . . or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.212 b. spending power congress utilizes medicare as a tool to achieve broad social policy goals by means of its spending power and attaching conditions to the receipt of federal funds. the constitution gives congress the power to "lay and collect taxes ... to pay the debts and provide for the common defence and general 207. see social security amendments of 1965, pub. l. no. 89-97, 79 stat. 286 (codified as amended in scattered sections of42 u.s.c.). h.r. rep. no. 89-213 (1965); s. rep. no. 89404 (1965) (reprinted in 1965 u.s.c.c.a.n. 1943); conf. rep. no. 682 (1965) (reprinted in 1965 u.s.c.c.a.n. 1943). 208. dean m. harris, symposium, the future of medicare, post great society and post plus-choice; legal and policy issues; beyond beneficiaries: using the medicare program to accomplish broader public goals, 60wash & leel. rev. 1251, 1312 (2003). 209. id. 210. id. see discussion infra part v.d. 211. id 212. 42 u.s.c. § 1395 (2005). 2006] state innovation in health care 293 welfare of the united states. "213 this section confers upon congress the power to tax and spend, however, the power to tax is explicit and the spending power is an amalgamation of judicial decisions. in united states v. butler,214 the supreme court construed the phrase ''provide for the ... general welfare" to mean congress has the power to tax "for the pwpose of providing funds ... for the general welfare;ms or congress has the power to spend taxpayers dollars for the general welfare. congressional power to spend is not limited by legislative power in the constitution;216 rather restrictions on the spending power are limited by the broad interpretation that spending supports the general welfare.211 today, the spending power enables congress to indirectly accomplish policy objectives which it could not accomplish directly under powers granted by the constitution. 218 attaching conditions to the receipt of federal funds, congress exercises broad control over states' and private entities' activities frequently. 219 unlike the commerce clause, the supreme court has not limited congress' spending power. in rust v. sullivan, the court held that ''when the government appropriates public funds to establish a program it is entitled to define the limits of that program."220 in south dakota v. dole,221 the leading spending clause case, the court affirmed that congress has wide latitude to exert federal power by attaching conditions in order to participate in federal programs. in dole, south dakota challenged a federal statute withholding a percentage of federal highway funds from states that maintained lawful drinking ages below twenty-one. synthesizing the law of previous decisions, the court found only four limitations upon the spending power: (1) the exercise of power must be in furtherance of the general welfare; (2) conditions imposed upon the receipt of federal funds must be unambiguous, enabling the recipient to make a choice 213. u.s. const. art. i,§ 8, cl.l. 214. united states v. butler, 297 u.s. 1, 64 (1936). 215. id 216. id at 65-66. 217. helveringv. davis, 301 u.s. 619,640 (1937). 218. andrew jay mcclurg, your money or your life: interpretingthefederalactagainst patient dumping, 24 wake forest l. rev. 173, 229-30 (1989). 219. id see, e.g., national highway safety act, 23 u.s.c. § 402 (a) (2005) (requiring states have a highway safety program approved by the secretary); rehabilitation act of 1973, 29 u.s.c. § 794 (2005) (prohibiting discrimination against person by reason ofhandicap in any program receiving federal funds); public works employment act of 1977, 42 u.s.c. § 6705(f)(2) (2005) (requiring that at least ten percent of federal funds allocated under the act be used to procure services from minority businesses). 220. rust v. sullivan, 500 u.s. 173, 194 (1991) (upholding the health department regulations limiting the ability oftitle x fund recipients to engage in abortion-related activities and stating that preventing a physician from giving abortion information if receiving title x funds does not violate the first or fifth amendments). id 221. south dakota v. dole, 483 u.s. 203 (1987). 294 indiana healnl law review [vol. 3:263 with knowledge of the consequences; (3) the conditions must be related or relevant to the federal interest in the particular national project or program; and ( 4) the conditional grant of funds must not conflict with any independent constitutional provision.222 south dakota relied on the fourth limitation, claiming the condition conflicted with .the twenty-first amendment, which gives the states broad power to impose restrictions on the sale and distribution of alcoholic beverages. 223 the court rejected that claim and held that congress did not use its power to induce the states to engage in activities that would themselves be unconstitutiona1.224 amici, which included several states, urged the court to use dole as a vehicle for establishing a rule that provides for the receipt of federal funds are legitimate only if they directly relate to the purpose of the expenditure.225 the court, however, declined to apply this direct relationship test and in a footnote stated that ''we do not address whether conditions less directly related to the particular purpose of the expenditure might be outside the bounds of the spending power."226 this footnote may leave the door open for the court to declare a condition attached to federal funds unconstitutional when it is insufficiently related to the purpose of the expenditure. 227 still, if the court were to adopt the direct relationship test, dole is illustrative of how distant a connection the court is willing to accept as satisfying the test.228 on a positive note, justice o'connor's dissent in dole endorsed the position that "congress has no power under the spending clause to impose requirements on a grant that go beyond specifying how the money should be spent." 229 the court has not completely defined the extent to which congress may place conditions on spending grants. instead, the court has relied on the coercion tesf3° which is incapable of invalidating any conditional spending provision.231 thus, the coercion test has allowed congress to use grants as a means of avoiding constitutional restrictions on its powers. 232 the court can close this loophole by limiting the conditions attached to federal spending programs to those that are directly related to the objective of the expenditure.233 congress' use of the spending power has affected political accountability, the tenth amendment, and the balance of power between state 222. /d. at 207-08. 223. /d. at 209. 224. /d. at 211. 225. /d. at 209 n.3. 226. /d. 227. mcclurg, supra note 218, at 231. 228./d. 229. dole, 483 u.s. at 21516 (o'connor, j .. dissenting). 230. see discussion infra part vi.b. 231. donald j. mizerk, note. the coercion test and conditional federal grants to the states, 40 v and. l. rev. 1159, 1193 (1987). 232. /d. 233. /d. at 1194 (citing texas v. united states, 730 f.2d 339,355 (5th cir. 1984)). 2006] state innovation in hbal111 care 295 and federal governments.234 when determining whether federal grants to the states are constitutional, the court should not simply decide that the states have the option to refuse the benefit and avoid any restriction~23s instead, the court should first determine whether congress has the power to place the restriction on the states. 236 even as the court narrows· the outer boundaries of federal power, congress' ability to regulate broadly through conditional spending is assumed, which serves to reassure those troubled by the court's supposed anti-federal direction. when, for instance, the court in printz invalidated provisions of the brady handgun violence prevention act on tenth amendment grounds, justice o'connor quickly noted in her concurring opinion that "[the court's] holding ... does not spell the end ... [to] the brady act ... [because] congress is ... free to amend the interim program to provide for its con­ tinuance on a contractual basis with the states if it wishes, as it does with a number of other federal programs. h237 although the commerce clause is not powerless, the spending power is the true strength of. federal control, especi­ ally in the context ofhealth care which relies heavily on federal funding.238 c. public funds and grants the grant system enables the federal government to regulate state governments and impose conditions on the private providers of social services. 239 as a condition of grants, congress can demand compliance with its socioeconomic, administrative and fiscal policies.240 since the court's federalism decisions make direct federal regulation of the states increasingly difficult.· the power of these grants as policy tools is especially attractive now.241 a conditional grant falls within congress' article i spending power; and because it is a carrot that a state can refuse, rather than a stick that it cannot, even grants that require states to pass legislation are not considered to be unconstitutionally coercive. 242 the grant allows the federal government to purchase services for third parties and regulate the delivery of those services simultaneously.243 234. ld. 235. id 236. id 237. printz, 521 u.s. at 936 (o'connor, j., concuning). 238. outterson, supra note 7, at538-39. 239. jody freeman, symposium. the contracting state, 28 fla. st. u. l. rev. 155, 167 (2000). 240. id 241. id 242. id. at 167-68 (citing dole, 483 u.s. at 211-12 (differentiating between financial "encouragement" and financial "coercionj). 243. id at 168. 296 indiana health law review [vol. 3:263 for example, when a state receives medicaid funds, it must adhere to various provisions of the social security act, the balanced budget act, and a host of federal regulations promulgated by the department of health and human services ("hhs"). 244 compliance with these requirements is a condition of receiving the program funds. the relationship between the federal agency responsible for medicaid oversight and the health care pro­ viders delivering care to medicaid patients is dependent on a web of regula­ tion.245 through a series of multi-layered contractual agreements the federal government exercises coercive power over the delivery of health care.246 d. supporting broader federal policy goals 1. regulations for medicare participation medicare and medicaid participation is a device often employed by the federal government to enforce compliance when it lacks the constitutional power to otherwise control states or private entities. for instance, when the federal administration was faced with california law legalizing medicinal marijuana, it proposed enforcement strategies such as suspending the medical licenses of all physicians who prescribed marijuana to their patients, or making those physicians ineligible for medicare and medicaid participation. 247 many physicians conceded that these threats would prevent them from recommending the drug. 248 as another example, a majority of states on their own accord have enacted inquiry laws that require hospital administrators to discuss with next of kin the option of donating organs of a decedent. 249 still, the federal government has denied medicare participation to hospitals that fail to "assure that families of potential organ donors are made aware of the option of organ or tissue donation and their option to decline .... "250 these participation regulations, however, are not limited to medicare patients. 244. see 42 u.s.c. § 1396 (2004); 42 c.f.r. §§ 430-56 (2005). 245. freeman, supra note 239, at 169. 246. !d. 247. newbern, supra note 11, at 1577 (citing william claiborne, federal warning on medical marijuana leaves physicians feeling intimidated, wash. post, jan. 1, 1997, at a6). 248. !d. 249. theodore silver, the case for a post-mortem organ draft and a proposed model organ draft act, 68 b.u. l. rev. 681, 707-08 (1988). !d. 250. 42 u.s.c. § 1320b-8 (a)(ixa)(i)(2005). the statute provides, in part: (1) the secretary shall provide that a hospital meeting the requirements of subchapter xviii or xix ... [is eligible for certain types of federal funding and reimbursement programs j only if (a) the hospital establishes written protocols for the identification of potential organ donors that (i) assure that families of potential organ donors are made aware of the option of organ or tissue donation and their option to decline, (ii) encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of such families ... 2006] stateinnovationinhealthcare 297 2. arbitrary medicare regulations congress enacted the emergency medical treatment and active labor act in 1986 (emt ala), 251 that requires hospitals to accept emergency cases and women in labor in order to participate in the medicare program. 252 if a hospital fails to comply with the act, it is subjected to suspension or termination of the privilege to receive federal medicare funds. 253 over ninety­ eight percent of the nation's hospitals participate in medicare.254 for many hospitals, terminating the flow ofmedicare funds would require them to close their doors. the question arises whether congress has the constitutional spending power to attach these unrelated conditional provisions to the receipt of federal medicare funds. 255 applying the four criteria set out in dole,256 emtala surely furthers the general welfare, and it does not violate any independent constitutional provision. emt ala, however, arguably fails the second and third limitations on the spending power, the requirements that the conditions be unambiguous and related to the purpose for which the funds are spent. 257 first, many of the definitions in the act are vague and some of the mandates are beyond a hospital's control.258 second, the condition is not related to the purpose of the funding because only a small number of persons seeking emergency treatment will be medicare recipients. 259 in fact, there is little incentive to refuse treatment to a medicare patient because medicare offers hospitals an important source of compensation. further, emtala's constitutionality is suspicious because of its coercive effect. the supreme court has historically recognized a difference between conditions attached to spending grants that simply induce and those that coerce, finding coercion violates the spending power. 260 just like other spending power limitations, the coercion test is interpreted broadly. the general view is that recipients of federal funds are free to accept the funds 251. 42 u.s.c. § 1395dd (2005). emtala was enacted as part of the consolidated omnibus budget reconciliation act of 1986 (cobra). id. 252. id. § 1395cc(axl) (2005). 253. id. § l395dd(dx1) (2005). 254. u.s. department of health and human services 2005 cms statistics 80146-23597 providers and suppliers, available at http://new.cms.hhs.gov/medicaremedicaidstatsuppl downloads/2005 _ cms _statistics. pdf (last visited february 24, 2006). 255. mcclurg, supra note 218, 228-33. 256. see discussion supra part v.b. 257. mcclurg, supra note 218, at 230. 258. i d. (arguing that the abilityofthe hospital to guarantee an ambulance service's actions and know when a patient has been stabilized is ambiguous and may be unobtainable). 259. id. at 232. a 1986 cook county study showed only three percent of dumped patients were eligible for medicare. id. 260. steward mach. co. v. davis, 301 u.s. 548, 590 (1937) (recognizing that there may be a ''point at which pressure turns into compulsion, and ceases to be inducement ... "). 298 indiana ileal til law review [vol. 3:263 with the strings attached or reject them and act without restriction-no coercion is involved. the choice, however, between accepting medicare funding with emt ala restrictions attached or losing medicare funding is hardly a choice at all.261 the economic reality is that hospitals depend upon medicare funding for survival, and this distinguishes medicare/emt ala compliance from other spending power cases where the loss of federal funds has a minimal impact upon the recipient. 262 despite emtala's questionable constitutionality, the history of spending clause litigation does not suggest that hospitals can successfully challenge the act. 263 spending power limitations serve as little more than verbal appeasement and have never been used to strike down a conditional federal expenditure.264 to demonstrate just how tenuous a connection the federal government can achieve between medicare participation conditions and the purpose for which the funds are expended, the united states department of health and human services lists booting the cars of delinquent parents, denying passports, and prohibiting medicare participation by health care providers who owe support as congress' attempt to pursue child support enforcement. 265 once again, policing domestic issues is an area traditionally left to the states, and reducing the amount of medicare providers to accomplish a goal easily achieved by other means is poor public policy. vi. a national health care plan a comprehensive federal health care policy would have to deal with interrelated social, economic, and political issues in order to address the nation's health care needs.266 such a policy would need to achieve many of the following objectives: (1) make health care more accessible; (2) reduce or limit health care costs; (3) provide medical malpractice reform; ( 4) eliminate duplicate state health care and health-care related programs; and (5) pay for the increased use of health care services.267 comprehensive federal health 261. mcclurg, supra note 218, at 232. 262. id at 233 (citing dole, 483 u.s. at 2ll )(stating that states desiring a lower drinking age would "lose a relatively small percentage of certain federal highway funds," and this loss would not impinge upon a state's ability to continue functioning, so there really is free choice involved). 263. id. 264. mizerk, supra note 231, at 1170. 265. ann laquer estin, moving beyond the child support revolution 26 law & soc. inquiry 505, 525 n.10 (2001) (reviewing thomas oldham and marys. melli, eds. child support: the new frontier, 26 law & soc. inquiry 505, 512 n.lo (2001)). 266. james e. holloway, erisa, preemption and comprehensive federal health care: a call for "cooperative federalism" to preserve the states' role in formulating health care policy, 16 campbeill. rev. 405,445 (1994). 267. id. 2006] state innovation jn healtii care 299 care legislation that establishes a uniform and consistent policy would preempt an abundance of state law.268 a. is the spending power unconstitutional under a national health care plan? the spending power has been broadly intetpreted; applying the four limitations on spending that the court has articulated to date, 269 as well as the coercion test270 to a hypothetical situation will help illustrate. under a comprehensive national health care program (mega-care), the funding for the majority of americans will come from citizens' tax dollars collected by the federal government. if the federal government denies participation based on a provider engaging in activities such as embryonic stem cell research, abortion-related discussions/71 physician-assisted suicide or medicinal marijuana recommendations, is this a violation of the spending power of the constitution? unlike emtala, it certainly is debatable ifthe exercise of this power would be in the furtherance of the general welfare. so, perhaps mega-care violates the first limitation. in addition, the current court may see this power as a direct assault on federalism. the rust court, however, clearly held that ''when the government appropriates public funds· to establish a program it is entitled to define the limits of that program. "272 the second limitation-that the condition imposed on the recipient must be unambiguous-has been an issue with medicare participation regulations. 273 this proviso can easily be overcome, however, by more precise drafting of the mega-care act. third, the condition must be related to the federal interest of the national program. this limitation will be tough to violate under mega-care. under the current medicare program, denying participation to a provider based on activities with non-medicare patients seems too far removed. still, emt ala and dole demonstrate just how indirect of a relationship will be held to be permissible. the footnote in dole stated ''we ·do not address whether conditions less directly related to the particular purpose of the expenditure might be outside the bounds of the spending power."274 this leaves the opportunity open to declare future conditional attachments to federal funds unconstitutional. even so, in the wake of a government monopoly in health care, the relationship will be more direct because the majority of patients will 268. id at 445-46 (arguing that a comprehensive health care plan will preempt more state law than erisa). 269. dole, 483 u.s. at 207-08. 270. mizerk, supra note 231, at 1179-1185,1193-1194. 271. rust. 500 u.s. at 194. 272. id 273. see discussion supra part v.d.2. 274. dole, 483 u.s. at 209 n.3. 300 indiana heal til law review [vol. 3:263 be under the federally funded plan. therefore, almost any condition imposed on participation would be related to some recipient. the fourth limitation that the conditional grant must not conflict with any independent constitutional provision-would seem at first blush to be a clear violation of the tenth amendment grant of"[t]he powers not delegated to the united states by the constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people.'ms stated differently, all powers not enumerated to the.federal government shall be left to the states or the people. in printz, the court found that congress could not commandeer the states under the tenth amendment; however, justice o'connor pointed out in her concurring opinion that congress is free to proceed with the states on a contractual basis. 276 therefore in the name of receiving federal· funds, very few conditions will be found to induce the states to engage in activities that would themselves be unconstitutional. the coercion test is left, which in the past has been no limitation at all. 277 still, it may be premature to concede a challenge to the spending power based on coercion278 because a compre­ hensive program such as mega-care may surpass this outerconstitutionallimit of congress' power. a strong argument can be made that a monopoly by the federal government in health care leaves providers with no alternative but comply or leave the field. b. no limits-no state laboratories of democracy if the court does not limit congress' spending power, the effect will be that legislation passed by the constituents of a state is meaningless in areas that the federal government mandates as invalidating health care participation in mega-care. therefore, experimentation will be discouraged in areas that are not consistent with a national consensus. the result will be that the laboratories of democracy function of states can be regulated out of existence under mega-care. c. losing autonomy for uniformity even in a less comprehensive system, the fear is that "in providing a minimum standard and some uniformity, [a national health care policy] will have to control health care and health-related interests which are intertwined with numerous fields of state law and public policy . . . resulting in the undermining offederalism.''279 a comprehensive national health care system 275. u.s. const. amend. x. 276. printz, 521 u.s. at 936. 277. see discussion supra part v.b. 278. see mcclurg, supra note 218, at233 (stating the probability of success in challenging emtala's constitutionality is minimal). 279. litman, supra note 64, at 881 (quoting james holloway). 2006] state innovation in health care 301 should be approached with caution to prevent uniformity of federal regulatory compliance at the expense of state autonomy in an area as personal as health care. these choices may be reflective of moral choices that are particular to a state electorate or issues that require experimentation before putting the entire nation at risk. viii. conclusion the debate on health care reform is at the forefront of political rhetoric and an issue that must be addressed in the united states. nationalizing health care, however, is not the solution. a philosophical shift of the supreme court toward maintaining state control over traditional state functions is apparent by recent decisions. specifically, the court has limited the commerce clause, upheld the eleventh amendment restriction of judicial power under article ill, and refused to allow the commandeering of the state legislative process by the federal government under the tenth amendment. still, the court to date has not limited the current scope of the spending power. a cursory look at the medicare program demonstrates the power of the federal government when refunding citizens' tax dollars to the states. it can force compliance with mandates which have a tenuous connection with the purpose of the federal program. many providers must participate in medicare to remain solvent. nevertheless, with other options in health insurance and patient selection, the federal program is not a monopoly at this time. a national health care system, however, will create a government monopoly in health care and providers will have the option to take the carrot or starve. although an activist court is not the optimal solution, the spending power must be curtailed for federalism to survive under a national health care system. the exceptional nature of the american system is its bifurcated government created by the constitution. under a national health care system that coerces compliance in the name of the spending power, the vital laboratory of democracy function of the fifty states cannot survive. those areas of health care that require experimentation before nationwide imple­ mentation subjects the entire nation to them or those that may never achieve a national consensus because they are unique to an individual state electorate can be regulated out of existence if they do not support federal policy. gaining uniformity and economies of scale at the cost of accountability and individualism must be analyzed before delving into an untested universal plan in the wake of the current state ofmedicare. when a spoonful of sugar doesn't help the medicine go down: informed consent, mental illness, and moral agency erin talatt table of contents introduction •...••••.•..••••••••••••..••••...•••....••••..•••••....•••....••••...••••..••..•••••..••.• 173 i. all interventions between health care provider and patient require informed consent ........................................ 174 a. the informed consent requirement follows a dissonant history of deference to physician judgment ........................................ 174 b. general requirements of adequate informed consent include competence, knowledge, and voluntariness ........................... 176 1. a determination of competence should be made prior to disclosure of information ................................................... 177 2. the knowledge requirement correlates with the physician duty of disclosure ............................................................... 178 3. the requirement that informed decisions be voluntary provides the last protection for patients ............................ 181 h. mental illness raises special considerations when contemplating informed consent .......................................... 182 a. many individuals with mental illness may not have the requisite capacity to consent ................................................................. 182 b. knowing how far the duty to disclose extends becomes especially di.fftcult when dealing with mental illness ............ 185 1. treatments for mental illness are incompletely developed and carry with them the risk of significant adverse effects ....... 186 2. the physician perspective standard provides a great deal of deference in disclosure to patients ..................................... 189 3. the "patient centered" materiality standard inadequately accounts for variability in symptoms of mental illness ...... 190 c. individuals with mental rlness are particularly vulnerable to coercion that may make consent involuntary ......................... 191 ill. where informed consent is legally ineffective because of coercion, the condffions winch made it coercive also makeitunetihcal ...................................................................... 193 * j.d. cum laude, 2007, university of pennsylvania law school, md, m. bioethics, 2007, university ofpennsylvania school ofmedicine. housesta.fl: university of chicago hos­ pitals. the author thanks with appreciation karyn brudnicki for her careful editing skills and thoughtful suggestions on an earlier draft of this manuscript. all errors and opinions are mine. 172 indiana heal til law review [vol. 6:171 a. informed consent respects the principle of autonomy ........... 194 b. theories of biomedical ethics are based on respect for the individual and generally function in concert with autonomy . ................................................................................ 195 1. beneficence ........................................................................ 195 2. nonmale.ficence ................................................................. 195 3. justice ................................................................................ 196 4. autonomy ........................................................................... 196 c. beyond traditional principles of biomedical ethics: moral agency in the general community still requires autonomy ... 197 conclusion ............................................................................................. 199 abstract when a patient disagrees with a treatment recommendation or requests a treatment not specifically recommended for the particular situation under con­ sideration, medical teams often turn to ethicists. the ethical inquiry usually begins in the same place: does the individual in question have the decisional capacity to refuse or request whatever is at issue? really, this question asks whether this individual has the moral agency to act in the way she is acting. mental illness complicates the analysis. when the legal requirements for consent cannot be met or circumstances render it necessary for a mentally ill individual to be medicated, the require­ ment for consent is suspended. in other situations, it is questionable whether ordinary consent by an individual with mental illness is really informed despite our reliance on these decisions in determining whether an individual has a place in a particular moral community. because a large emphasis in criminal law is placed on the mentally ill individual taking responsibility for her illness through medication compliance, 1 compliance with treatment might inform whether we view her choices as moral. if the validity of consent to treatment comes into question, however, an expectation to conform to a treatment regimen may itself be unethical. this article concludes that consent obtained by conditioning moral standing on medication compliance is legally invalid due to coercion and ethically invalid because it undermines autonomy thereby undermining the very basis of moral agency. treatment-absent valid consent in these situations-­ may be ethical sometimes, but should not be justified on the basis of informed consent. l. see generally michael d. slodov, criminal responsibility and the noncompliant psychiatric offender: risking madness, 40 case w. res. 271 (1990)(arguing that an offender who has been noncompliant with a prescribed medication regimen should not be allowed to subsequently claim an insanity defense because of her failure to ameliorate the effects of her illness). 2009] informed consent, mental illness, and moral agency 173 introduction in the medical world, we call into question the individual's moral agency on a regular basis. almost any time a patient disagrees with a treatment rec­ ommendation or requests a treatment not specifically recommended for the par­ ticular situation under consideration, medical teams often turn to ethicists for help. the ethical inquiry usually begins in the same place in every case: does the individual in question have the decisional capacity to refuse or request whatever is at issue? actually, this question asks whether this individual has the moral agency to act in the way she is acting. mental illness greatly compli­ cates the analysis. mental illness raises a number of concerns that motivate different ap­ proaches to its treatment. a predicate to any treatment in the medical context is obtaining the informed consent of the patient. in some situations, when the legal requirements for consent cannot be met or circumstances render it neces­ sary for a mentally ill individual to be medicated for the safety of others, this requirement of consent is suspended, and such situations are not the focus of this discussion. for the mentally ill patient, in other situations, however, it is questionable whether ordinary consent is really informed despite our reliance on these decisions in determining whether an individual has a place in a par­ ticular moral community. because a large emphasis in criminal law is placed on the mentally ill individual taking responsibility for her illness through medi­ cation compliance/ conformity (or non-conformity) to a treatment regimen might inform whether we view his or her choices as moral or ethical. when one considers the fact that it may be a rational decision to forego treatment for men­ tal illness, 3 the question arises whether consent agreeing to a treatment regimen can be informed. if the validity of the consent to treatment comes into question, one must also consider whether the expectation to conform to a treatment regi­ men is itself unethical. this article asks whether it is legally or ethically valid to grant moral agency to an individual with mental illness based on whether she assumes re­ sponsibility for her mental illness, particularly through compliance with a rec­ ommended treatment regimen. part i of this article discusses the history and legal requirements of the informed consent doctrine. part ll considers informed consent in the context of mental illness and concludes that treatment of in­ formed consent in mentally ill persons must be regarded even more stringently than in the traditional context because of increased vulnerability of this popula­ tion to coercion. part ill contemplates whether consent that may be considered 2. see generally id. 3. see jessica l. mackeigan, note, violence, fear, and jason's law: the needless expansion of social control over the non-dangerous mentally ill in ohio, 56 clev. st. l. rev. 739, 752 n. 97 (2008) ("a decision not to comply [with medication] may be more indica­ tive of an aversion to medication side effects than to a lack of competence or an inability to make an informed treatment decision."). 174 indiana health law review [vol. 6:171 legally invalid on the basis of coercion is ethical, finding ultimately that equat­ ing moral standing in a community with whether or not a mentally ill individual chooses to comply with recommended treatment exerts an undue influence on that individual's ability to give informed consent. moreover, failure to obtain valid informed consent undermines autonomy, and because autonomy is requi­ site for moral agency, any action which undermines autonomy will also under­ mine moral agency. the multi-step argument essentially concludes that conditioning moral standing in a community on a mentally ill individual's ac­ ceptance of a medication treatment regimen will itself undermine moral agency. treatment, absent valid consent in these situations, may be ethical sometimes, but should not be justified on the basis of informed consent. this article does not aim to imply that consent can never be obtained from individuals with men­ tal illness nor that treatment is never appropriate in individuals whose consent cannot be voluntary, only to say that in these cases, rather than creating a fic­ tional belief of consent, the criteria for involuntary treatment must be realized.4 i. all interventions between heal1h care provider and patient require informed consent a long history of cases dealing with unauthorized acts by health care pro­ viders form the foundation for the modern concept of consent. informed con­ sent requires competence, knowledge, and voluntariness. 5 a. the informed consent requirement follows a dissonant history of de­ ference to physician judgmenf informed consent is now the cornerstone of any contact between a health care provider and a patient. the modern rule requiring informed consent for every medical intervention follows a long history ofbehaviors inconsistent with the stated requirements for consent. thought to be a seminal case in informed 4. involuntary treatment can only be imposed when due process is afforded to the indi­ vidual being treated. see washington v. harper, 494 u.s. 210,225-26 (1990) (requiring due process for involuntary medication of individuals with mental illness); addington v. texas, 441 u.s. 418, 427 (1979) (discussing the due process rights of individuals with respect to involunta­ ry commitment). while assisted outpatient treatment statutes are not the focus of this article, they too raise concerns about due process and have been challenged on these grounds, reaffinn­ ing the need for due process whenever true consent cannot be obtained for treatment. see in re k.l. 806 n.e.2d 480 (n.y. 2004) (finding no due process violation in the application of the assisted outpatient treatment statute considered in that case); in re urcuyo 714 n.y.s.2d 862 (n.y. sup. ct. 2000) (implying that forced medication without a finding of incapacity might violate due process). 5. see infra part ll.b. (discussing the elements of the informed consent doctrine). 6. for a general overview of informed consent history, see joan l. o'sullivan and breck g. borcherding, informed consent for medication in persons with mental retardation and mental illness, 12 heal'ihmatrjx 63,66-69 (2002). 2009] informed consent, mental illness, and moral agency 175 consentjurisprudence, the 1914schloendorffv. societyofnew yorkhospitaf case held that unless a patient is unable to consent and an emergency interven­ tion is necessary, any intervention by a physician done without consent consti­ tutes assault. 8 the court opined that, "[ e ]very human being of adult years and sound mind has a right to determine what shall be done with his own body."9 the schloendorff decision however, was arguably neither particularly novel nor especially effective in changing physician practice. the court's language was reminiscent of justice gray's earlier pronouncement in the supreme court's first impression on informed consent that, "[t]he right to one's person may be said to be a right of complete immunity: to be let alone. "10 in addition, follow­ ing the schloendorff decision, little changed in the deference given to physi­ cians in carrying out their duties. during the 1950s, the landscape finally began to change. initially, cases during this period continued to be deferential to physicianjudgment.11 in 1957, 7. 105 n.e. 92 (n.y. app. 1914). the patient in this case presented to the defendant hospital with abdominal complaints. i d. at 93. a mass in the lower abdomen was appreciated on physical exam but could not be more fully characterized without a further invasive internal ex­ amination under anesthesia. ld the plaintiff contended that she consented to such an examina­ tion but stipulated that there should be no operation. id. when she awoke from anesthesia, a fibroid tumor had been removed. ld she argued that the operation was performed with neither her knowledge nor consent. ld. 8. id. at 93 ("[a] surgeon who performs an operation without his patient's consent, commits an assault, for which he is liable in damages. this is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be ob­ tained.''). 9. ld. the schloendorff case is particularly notable because it involved harm resulting from active intrusion, "trespass" into the patient's body rather than "mere negligence.'' id. significantly, the court foretold an essential element of informed consent doctrine relevant to mental illness. the court stated that only those "of sound mind" could invoke this right of self determination regarding his body. id. at 129. 10. union pac. r.r. v. botsford, 141 u.s. 250, 251 (1891) (quoting thomas mcintyre cooley, a treatise on 1lle law of torts, or, the wrongs wjdch arise independent of contract 29 (callaghan & company 2nd ed. 1888) (1880)) (internal quotations omitted). in this case, the court held that a woman could not be forced to undergo a surgical exam by physi­ cians chosen by the railroad when she sued them for injuries sustained as a result of alleged negligence on the part of the railroad. see id. ("the single question presented by this record is whether, in a civil action for an injury to the person, the court, on application of the defendant, and in advance of the trial, may order the plaintift without his or her consent, to submit to a surgical examination as to the extent of the injury sued for. we concur with the circuit court in holding that it had no legal right or power to make and enforce such an order."). see also louis brandeis and samuel warren, the right to privacy, 4 harv. l. rev. no. 5 (1890) (stating, while making an argument that a right to privacy exists, that "now the right to life has come to mean the right to enjoy life,-the right to be let alone''). ll. see kennedy v. parrott, 90 s.e. 2d 754, 759 (n.c. 1956) (holding that a surgeon who extended an operation beyond that for which consent had been obtained was not liable for inju­ ries resulting from this extension because it was his duty to perform an operation consistent with good surgical practices and he was free to exercise his informed judgment as to what good prac­ tice required). but see rogers v. lumbermens mutual casualty co., 119 so.2d 649, 652-53 (la. app. 2d cir. 1960) (holding neither express nor implied consent for a surgeon to extend surgery in a non-emergent situation beyond what had been consented even if exercising good faith judgment in his performance). 176 indiana realm law review [vol. 6:171 the "duty to disclose" was born in california, marking a departure from prior jurisprudence.12 "a physician violates his [affrrmative] duty [to disclose] to his patient and subjects himself to liability if he withholds any facts which are ne­ cessary to form the basis of an intelligent consent by the patient to the proposed treatment."13 in further describing this duty, the court announced a correspond­ ing negative duty to refrain from, ''minimiz[ing] the known dangers of a proce­ dure or operation in order to induce his patient's consent."14 recognizing that this expectation could place physicians in a situation in which patients might reject interventions involving little practical risk due to placing an excessive emphasis on the dangers associated with the procedure, the court concedes that "the patient's mental and emotional condition is important ... and that in dis­ cussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure offacts necessary to an informed consent."15 the duty to disclose included some degree of judgment on the part of the phy­ sician but in essence established, for the first time, that a patient had a right to an opinion and informed direction over her care.16 balancing physician judg­ ment with the requirement of consent requires the physician to understand the criteria essential for adequate informed consent so that she might know how to best take the patient's "mental and emotional condition" into account in meet­ ing her duty. b. general requirements of adequate informed consent include compe­ tence, knowledge, and voluntariness informed consent combines the duty to disclose with a requirement that the consenting individual is capable of understanding the information pre12. see salgo v. leland stanford jr. univ. bd. oftrs., 317 p.2d 170, 181 (cal. ct.app. 1957) (holding a surgeon liable for performing a surgical procedure without informing the pa­ tient of what the procedure involved). 13. /d. at 181. 14. /d. 15. /d. (emphasis added). this realization on the part of the court is important. this flex­ ibility may be necessary for certain extreme situations which the court seems to contemplate where a particularly risk averse patient may refuse a treatment that could be lifesaving and has little probability of risk, however, the judgment component has potentially more significant risks, especially in the context of mental illness. it admits that mental conditions may influence a person's decision-making regarding medical interventions, but it does not explicitly acknowl­ edge that this vulnerability permits a provider or other person who may have some authority over whether a mentally ill person is or is not medicated to have discretion in creating the pic­ ture she wants the mentally ill person to envision in order to ensure compliance with a medica­ tion regimen under the illusion that consent is present. see discussion infra part ii.b.2. 16. see natanson v. kline, 350 p .2d 1093 (kan. 1960)( delineating further the physician responsibility to inform a patient regarding her care and seek input on her desired course of action); see also ashcraft v. king, 228 cal. app. 3d 604 (1991) (allowing greater patient in­ volvement in care by placing conditions on consent); restatement second oftorts § 89(a)(2) (1965) (permitting conditions to be placed on individuals which limit the scope of consent). 2009] informed consent, mental illness, and moral agency 177 sented. requiring that the individual is competent, that she is free of undue in­ fluences in making the decision, and that her decision is voluntary. 17 1. a determination of competence should be made prior to disclosure of information prior to disclosing risks and benefits attendant to any medical interven­ tion, the physician must judge the capacity of the patient to give consent.18 the competency question must be resolved before determining whether a duty of disclosure has been met, because if incompetent, a patient by definition lacks the ability to logically understand and incorporate the knowledge disclosed, 19 therefore making her consent necessarily invalid. 2° four commonly accepted components of competency include: "(i) ability to communicate a choice, (ii) ability to understand relevant information, (iii) ability to appreciate the nature of the situation and its likely consequences, and (iv) ability to manipulate in­ formation rationally.'.z1 these factors, identified initially in a non-legal context, appear to influence judicial determinations of informed consenf2 and can there­ fore be used as a standard against which a clinician may judge capacity and an observer may judge whether adequate consent was obtained. 17. informed consent is a legally charged concept; although different disciplines may inform what constitutes valid consent, jurisprudence focuses on the three factors of competency, disclosure, and voluntariness. see alan meisel et. al, toward a model of the legal doctrine of informed consent, 134 am. j. psychiatry, 285,285 (1977) (''the components [of informed consent] consist of the precondition ofvoluntariness, the provision of information, the patient's competency and understanding, and, finally, consent or refusal.") 18. because competence is a legally defined term, a finding of competency itself is gener­ ally left for court determination. a professional's judgment of capacity, or lack thereof, may be factored into the legal determination of competency. see jessica wilen berg, et al., construct­ ing competence: formulating standards of legal competence to make medical decisions, 48 rutgers l. rev. 345, 346-4 7 n.14 (discussing the capacity-competence distinction). the terms are often used interchangeably in literature describing an individual's ability to make medical decisions. 19. the american medical association recognizes that individuals suffering ftom mental illness raise special considerations with regards to their competence. see council on ethical and judicial affairs, "court-initiated medical treatment in criminal cases," ceja report 4-a-98, (american medical association, 1998), available at www.ama-assn.org/amallpub!uploadlmm/ code-medical-ethics/2065a.pdf [hereinafter "ceja report 4-a-98'1; see also infra part ll (ex­ plaining the complexities of applying the informed consent doctrine to decisions by individuals with mental illness). 20. see berg, supra note 18. at 351. 21. see id. (quoting paul s. appelbaum & thomas grisso, assessing patients' capacity to consent to treatment, 319 neweng.j. med. 1635, 1635-38 (1988)). 22. for a classification of different judicial determinations by the standards referenced above, see berg, supra note 18, at 351 ("[t]hree or four compound standards [are] actually found in the cases and statutes: (i) choice and understanding, (ii) choice, understanding and appreciation, (iii) choice, understanding, appreciation, and reasoning, or (iv) choice, understand­ ing and reasoning."). 178 indiana heal til law review [vol. 6:171 2. the knowledge requirement co"elates with the physician duty of disclosure early formulations of informed consent described the physician's duty to disclose information as requisite for valid consent. 23 consent is invalid when given without adequate knowledge of the risks and benefits related to a particu­ lar intervention.24 historically, the majority view considered the physician's perspective to judge whether the duty of disclosure was met.25 one application of the physician perspective view employs a customary practice standard to de­ termine whether the disclosure of information by a physician was sufficient. under this approach, disclosure is mandated unless it either (1) does not fall within the customary practice of physicians or (2) would contravene community or national medical standards. 26 several states adopt the customary practice standard, which often requires expert testimony to establish. 27 another some­ what more common approach is based on the physician's perspective and judges the adequacy of disclosure based on whether the physician acted in the 23. seegenerallysalgov. leland stanford jr. univ. bd. oftrs., 317 p.2d 170(cal. ct. app. 1957) (marking one of the first formulations of the duty to disclose). 24. see laurent b. frantz, modern status of views as to general measure ofphysician s duty inform patients of risks of proposed treatment, 88 a.l.r. 3d 1008 at § 2 ( 1978). 25. see robert d. mnler, problems in healm care law 343 (9th ed. 2006) (noting that the current majority view is the reasonable patient standard). 26. see frantz, supra note 24, at § 3. 27. see e.g., hales v. pittman, 576 p.2d 493, 499 at n. 4 (ariz. 1978) ("the precise para­ meters of the required disclosure for any particular case is to be established by expert testimony in accordance with the applicable standard of medical care."); eady v. lansford, 92 s. w.3d 57, 60 (ark. 2002) ("[1]he duty of a physician to disclose is measured by the customary disclosure practices of physicians in the community ora similar community."); cobbs v. grant, 502 p.2d 1, 12 (cal. 1972)(describingthatundercertaincircumstances, "[a] disclosure may need not be made beyond that required within the medical community."); bloskas v. murray, 646 p .2d 907, 914 (colo. 1982) (''the precise scope of the physician's duty of disclosure is determined on the basis of expert testimony demonstrating the extent of information given by reasonably careful physicians practicing the same specialty in the same or similar community.''); himes v. gabriel, 2009 del. lexis 205, 206 (del. sup. ct. 2009) ("delaware law limits a physician's duty by re­ quiring an injured party to prove that •the health care provider did not supply information re­ garding such treatment, procedure or surgery to the extent customarily given to patients, or other persons authorized to given consent for patients by other licensed health care providers in the same or similar field of medicine as the defendant."); whittington v. mason, 905 so2d 1261, 1266 (miss. 2005) ("we hold that a plaintiffmustproduceexperttestimonytoestablish material risks."); curran v. buser, 711 n. w.2d 562, 571 (neb. 2006) ("[i]nformed consent means •con­ sent to a procedure based on information which would ordinarily be provided to the patient under like circumstances by health care providers engaged in a similar practice in the locality or in similar localities . .,'); mcpherson v. ellis, 287 s.e.2d 892, 897 (n.c. 1982) (citing state law which considers both the customary practice and the reasonable patient standards valid); sha­ drick v. coker, 963 s.w2d 726, 732 (tenn. 1998) ("depending on the usual and customary advice given to patients to procure consent in similar situations, the health care provider must typically inform the patient of the diagnosis or nature of the patient's ailment."); tashman v. gibbs, 556 s.e.2d 772, 777 (va. 2002) ("we have defined the standard of care in a medical malpractice action as that degree of skill and diligence exercised by a reasonably prudent practi­ tioner in the same field of practice or specialty in virginia."). 2009] informed consent, mental lu..ness, and moral agency 179 manner that a reasonable physician under the circumstances might have acted. 28 both physician perspective views are consistent with the court's determination that some physician discretion may be appropriate-and indeed indicated­ while still fulfilling the duty of disclosure. 29 concerns regarding potential abuse of discretion and threats to patient au28. other states have applied the professional standard from the standpoint of the reason­ ably prudent practitioner. see, e.g., fain v. smith, 479 so.2d 1150, 1152 (ala. 1985)("1n per­ forming professional services for a patient, a physician's, surgeon's, or dentist's duty to the patient shall be to exercise such reasonable care, diligence and skill as physicians, surgeons, and dentists in the same general neighborhood, in the same general line of practice, ordinarily have and exercise in a like case."); bloskas v. murray, 646 p.2d 907,914 (colo. 1982)("[a] claim in medical malpractice requires proof that the physician failed to exercise that degree of know­ ledge, skill and care used by other physicians practicing the same specialty."); thomas v. ber­ rios, 348 so.2d 905, 908 (fla. dist. ct. app. 1977) ("expert testimony is required in informed consent cases to establish whether a reasonable medical practitioner in the community would make the pertinent disclosures under the same or similar circumstances."); doreika v. blotner, 666 s.e.2d 21, 24 (ga. ct. app. 2008) (requiring disclosure that would be provided by "reason­ ably prudent physicians" and that would be expected by "a reasonably prudent person"); li­ sowski v. macneal mem. hosp. ass'n. 885 n.e. 2d 1120, 1136 (ill. app. ct. 2008)(adopting a standard relying on what "the reasonable medical practitioner of the same school, or in similar circumstances," would disclose); culbertson v. memitz, 602 n.e.2d 98, 104 (ind. 1992) (af­ firming the use of the "standard of a reasonably prudent physician."); leiker v. gafford, 778 p.2d 823,830 (kan. 1989) (accepting that "the duty of the physician is limited to those disclo­ sures which a reasonable medical practitioner would make under the same or similar circums­ tances."); foster v. oral surgery assocs., p.a. 940 a.2d 1102, 1106 (me. 2008) ("[t]he scope of a physician's duty to disclose is measured by those communications a reasonable medical practitioner in that branch of medicine would make under the same or similar circumstances ... . ");harnish v. children's hosp. med. ctr., 439 n.e.2d 240, 243 (mass. 1982) ("the informa­ tion a physician reasonably should possess is that information possessed by the average quali­ fied physician or, in the case of a specialty, by the average qualified physician practicing that specialty."); lowder v. united states, 831 f. 2d 785, 786 (8th cir. 1987) (supporting the patient centered approach to disclosure); robinson v. our sisters of charity, 963 p.2d455, 455 (mont. 1998) ("the duty of the physician to disclose, however, is limited to those disclosures which a reasonable medical practitioner would make under the same or similar circumstances."); curran v. buser, 711 n.w.2d 562, 571 (neb. 2006) ("[i]nformed consent means 'consent to a proce­ dure based on information which would ordinarily be provided to the patient under like circums­ tances by health care providers engaged in a similar practice in the locality or in similar localities"'); bronneke v. rutherford, 89 p.3d 40, 43 (nev. 2004) (supporting the professional medical standard for disclosure); davis v. nassau ophthalmic servs., p.c., 232 a.d.2d 358, 363 (n.y. app. div. 1996) (supporting the professional medical standard for disclosure); miller v. dacus 231 s.w.2d 903, 907 (ark. 2007) ("the 'appropriate information' that must be dis­ closed depends on the usual and customary advice given to patients to procure consent in similar situations."); tashman v. gibbs, 556 s.e.2d 772,777 (va. 2002) ("we have defmed the stan­ dard of care in a medical malpractice action as that degree of skill and diligence exercised by a reasonably prudent practitioner in the same field of practice or specialty in virginia."). this standard applies also to the degree of information the physician is expected to know. see mcgeshick v. choucair, 9 f.3d 1229, 1233 n.l (wis. 1993) ("physician's duty to inform [a] patient ... does not require disclosure of [ ] information beyond what reasonably well-qualified physician in similar medical classification would know .... "). 29. but see miller, supra note 25, at 343 ("the majority of states apply the reasonable patient standard under which the duty to disclose is determined by the patient's informational needs, not by professional practice."). see also generally salgo v. leland stanford jr. univ. bd. oftrs., 317 p .2d 170 (cal. ct. app. 1957). the concerns raised by the court in sal go partially explain the movement towards the patient centered view. 180 indiana health law review [vol. 6:171 tonomy motivated a shift to the previous minority standard of materiality in some jurisdictions, which has now become the majority view.30 rather than considering the physician perspective, the materiality standard instead considers what might be important to the decision maker. one formulation of this mi­ nority view requires the physician to disclose to the patient those risks that would be considered "material" to the patient in determining whether the pro­ posed treatment should be undertaken, 31 namely the knowledge a reasonable or 30. see karp v. cooley, 493 f.2d 408 (5th cir. 1974). the court in that case recognized that a minority of jurisdictions utilized this materiality approach before affirming their own be­ lief in the then majority physician perspective view. id. the patient centered view has since become the majority view. see miller, supra note 25, at 343 (describing the now majority pa­ tient centered view). 31. see canterbury v. spence, 464 f .2d 772, 786 (d.c. cir. 1972) (''the patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice."). the patient centered view is being upheld with greater frequen­ cy in more recent decisions. see korman v. mallin, 858 p .2d 1145, 1149 (alaska 1993) ("[t]he scope of disclosure required ... must be measured by what a reasonable patient would need to know in order to make an informed and intelligent decision about the proposed treatment."); eadyv. lansford, 92 s.w.3d57, 60(ark. 2002) (''the minority view is thatthedutyofaphysi­ cian to disclose is measured by the patient's need for information material to the patient's right to decide .... "); arato v. avedon, 858 p.2d 598, 607 (cal. 1993) ("[a] physician is under a legal duty to disclose to the patient all material information ... 'which the physician knows or should know would be regarded by a reasonable person in the patient's position."'); levesque v. bristol hosp. 943 a.2d 430, 443 (conn. 2008) ("[a] physician is obligated to provide the pa­ tient with that information which a reasonable patient would have found material for making a decision .... ");miller-mcgee v. wash. hosp. ctr., 920 a.2d 430, 440 (d.c. 2006) ("the test for mandatory disclosure of information on treatment of the patient's condition is whether a reasonable person in what the physician knows or should know to be the patient's position would consider the information material to his decision.''); barcai v. betwee, 50 p .3d 946, 960 (haw. 2002) ("in order to determine whether a physician owes a duty to disclose a particular piece of information to the patient, this court ... has adopted the "patient oriented standard."); kennis v. mercy hosp. med. ctr., 491 n.w.2d 161, 166 (iowa 1992) (utilizing the standpoint of a reasonable patient to judge whether a given risk is a material risk); jackson v. state, 938 so.2d 688, 690 (la. 2006) (indicating reliance on a standard that considers ''whether a reasona­ ble person in the patient's position would attach significance" to a risk); wolinski v. cohn, 713 n.w.2d 16, 21 (mich. 2005) (implying reliance on the "reasonably prudent patient"); plutshack v. univ. ofminn. hosp., 316 n. w.2d 1, 9 (minn. 1982) (relying on the reasonable person stan­ dard for disclosure); acuna v. turkish, 930 a.2d 416, 425 (n.j. 2007) ("a physician has a legal duty to disclose to the patient all medical information that a reasonably prudent patient would find material .... "); mcpherson v. ellis, 287 s.e.2d 892, 897 (n.c. 1982) (citing state law which considers both the customary practice and the reasonable patient standards valid); long v. jaszczak, 688 n.w.2d 173,180 (n.d. 2004) ("[u]ltimately, a 'trier of fact must determine whether a reasonable person in the plaintitr s position would attach significance to the specific risk.''); nickell v. gonzalez, 477 n.e.2d 1145, 1148 (ohio 1985) ("[t]he reasonable patient standard is utilized."); scott v. bradford, 606 p.2d 554, 558 (okla. 1979) (indicating that the standard for disclosure is not the professional standard but instead "based on the patient's need to know"); holland v. sisters of st. joseph ofpeace, 522 p.2d 208, 211 (or. 1974)(relying on the significance that a reasonable person would attach to a given risk); morgan v. macphail, 704 a.2d 617, 621 (pa. 1997) ("[a] doctor must disclose risks that a reasonable man would consider material .... ");beauvais v. notre dame hosp., 387 a.2d 689, 692 (r.i. 1978) (indicating that the jury should rely on the materiality of a given risk to a reasonable person"); savold v. john­ son, 443 n.w.2d 656,658 (s.d. 1998)("ariskis defined as material when a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to .... "); shadrick v. coker, 963 s.w.2d 726, 733 (tenn. 1998) (requiring 2009] informed consent, mental illness, and moral agency 181 prudent patient would require in order to make an informed decision. 32 the reasonableness element incorporated in this position asks the physician to con­ sider the relative weight an ordinary person might give to various risks and benefits of a particular decision. under this view, a specific risk or benefit, par­ ticularly when externally imposed, may shift from being important or material in the decision making process to becoming frankly coercive, and requires spe­ cial attention in the context of mental illness. 33 3. the requirement that informed decisions be voluntary provides the last protection for patients the final requirement for judging whether a decision to forego or under­ take a particular medical intervention was made with informed consent is that the decision was made voluntarily.34 "a decision is considered involuntary when some element is involved that prevents an individual from acting freely .. . . 'coercion is established by demonstrating that duress induced individuals to give their consent where they would not have otherwise done so. "'35 the liber­ al view of this voluntariness requirement for consent stipulates that "[t]he pa­ tient's decision should not be coerced or pressured by anyone,'.j6 while a more stringent view does not require all coercive circumstances to render a decision necessarily involuntary. 37 the impact of coercion in rendering consent involun­ tary might be explained by considering whether the coercive influence was in­ ternal to the individual's own value system or whether it was imposed externally and in such a way that negates autonomy. the bioethics literature offers an alternative understanding of coercion which considers certain controldisclosure of what a reasonable patient would care to know); stewart-graves v. vaughn, 170 p .3d 1151, 1155 (wash. 2007)(relying on state law requiring disclosure of facts felt important to a ''reasonably prudent person"); hannemann v. boyson, 698 n.w.2d 714, 725 (wise. 2005) (rejecting a standard based on the "customs of the profession"). 32. see chamberlain v. giampapa,210f.3d 154, 161-62(3rdcir. 2000)(describingthe ''reasonably prudent patient" standard); see also generally howard v. univ. ofmed. & dentistry ofn.j ., 800 a.2d 73 (2002) (upholding the ''prudent patient" or "materiality of risk'' standard). 33. see i'!franotes 38-39 and accompanyingtext(arguingthatextemallyimposed auton­ omy-negating factors are more likely coercive). the currently applied legal standard relies on the rational actor model to allow exploitation of external influences to occur, by heralding that a reasonable person must be told everything that could and should be potentially material to a decision regarding an intervention. when coupled with the view held by some that not all coer­ cive circumstances make a decision involuntary, the patient materiality standard may actually be dangerous for patients with mental illness where vulnerability to external influences can be ex­ ploited. see infra note 37 and part i.b.3 for a discussion of the voluntary requirement and the view that coercion does not always lead to a finding of involuntariness. 34. see ceja report 4-a-98, supra note 19, at 3 ("informed consent is by definition voluntary.''). 35. /d. (quotingka vanderzyl. castration as an alternative to incarceration: an impo­ tent approach to the punishment of sex offenders, 15 n.iil. l. rev. 107 (1994)). 36. o'sullivan & borcherding. supra note 6, at 72 (emphasis added). in the most liberal formulation of the voluntariness requirement, then, all coercion or pressure by anyone ( assu­ medly focusing on primarily external influences) invalidates consent 37. see ceja report 4-a-98, supra note 19, at 3 ("it is possible to give voluntary consent under certain coercive circumstances.''). 182 indiana health law review [vol. 6:171 ling external influences to be autonomy-negating and therefore coercive. 38 this view recognizes that factors external to the decision at hand which force a par­ ticular "choice" are coercive. 39 the risk of coercion is heightened in individu­ als with mental illness because of the particular influence of external factors in their decisions regarding treatment. ii. mental lllness40 raises special considerations when contemplating informed consent it can be particularly difficult-if not impossible-to obtain consent from individuals with mental illness without applying particular safeguards because of the impact that mental illness can have on one's capacity to understand and to weigh factors in a decision, and the frequent desire of individuals with men­ tal illness to be accepted in a moral community. a. many individuals with mental illness may not have the requisite capacity to consent a ftnding of competence is generally based on the interplay of several fac­ tors, including: rationality, understanding, the ability to weigh consequences, and the ability to communicate.41 data suggests that individuals with mental illness, however, are less likely to be competent in any one area. "[p]atients hospitalized with schizophrenia or depression more often show[] deftcits in 38. seem. gregg bloche, beyond autonomy: coercion and morality in clinical rela­ tionships, 6 realm matrix 229, 247 (1996) (explaining a three-part test for an autonomy­ negating external influence). the article also notes that a finding of coercion is not always per se immoral. see id. at 240 ("[t]he conclusion that an influence method constitutes coercion does not imply that the method is morally wrong."). part iii ofthis article argues that coercion in the context described in this paper, however, is immoral because it negates the principle of autonomy that is central to the moral theories discussed. 39. see id. at 244 (arguing that conditioning medical care for hiv-positive women on their decision towards reproductive abstinence is coercive). 40. the argument made here applies only to mental illness and not to mental retardation. this distinction is made for several reasons. first, mental illness and mental retardation raise similar but not identical concerns with regards to informed consent. second, the discussion regarding informed consent in this article precedes a consideration of what factors, including accountability, might be important in assessing the moral agency of mentally ill individuals. the tension between the expectation of accountability and the principle of autonomy inherent to the doctrine of informed consent is more pronounced in individuals with mental illness than in those with mental retardation. for ease of characterization, those disorders listed in the diag­ nostic and statistical manual iv, for example, depression, schizophrenia, and bipolar disorder, form the basis of this article's treatment of mental illness. furthermore, the discussion assumes that mental illnesses exist as diagnosable and potentially treatable conditions. thus, considera­ tions might attribute to this group of individuals that may not be as strongly supported in con­ sent discussions for non-mentally ill individuals. for a view that mental illness is a fiction, see thomas szasz, mental disorders are not diseases, usa today (2000), available at http://www.szasz.com/usatoday.html. 41. see supra notes 18-22 and accompanying text (describing the competence element of informed consent). 2009] informed consent, mental illness, and moral agency 183 their decision making than hospitalized medically ill patients and non-patient comparison groups.'"*2 furthermore, individuals with schizophrenia demon­ strate a greater deficit than individuals with depression.43 those "patients who manifesto greater severity of thought disturbances, also tendo to manifest defi­ cits in understanding and reasoning.'.« additionally, "although patients with schizophrenia show[] the greatest impairments, the majority of these patients perform[] in the ''unimpaired" range on each measure,..5 these individuals therefore will be judged competent by courts.46 on a normative level, the choice between standards [employed to judge competency] involves balancing the extent to which a failure to demonstrate the ability measured by a component indicates impaired autonomy in decisionmaking against whether such a failure is a sufficient basis for limiting a patient's decisionmaking authority. although seriously impaired people should be protected, the right to make decisions for oneself should not be burdened more than is absolutely necessary. in consequentialist terms the issue is whether the harm of incorrectly labeling autonomous agents as incompetent is outweighed by the harm of incorrectly labeling nonau­ tonomous agents as competent the former is a harm to the patient's autonomy, or right of self-determination. the latter is only significant to the extent that the pa­ tient's well-being is at risk; no harm results from allow­ ing an incompetent patient to make a decision of minimal effect or one that is in keeping with his or her objective best interests. only competent patients, how­ ever, are free to make decisions that are not in their best interests.47 42. berg, supra note 18, at 372. 43. id. 44. id. at 374. 45. id at 373. 46. id courts may choose to find a larger percentage of persons competent than would be judged competent by the statistical measures used in studies examining competence. see id. at n.92 (''there are problems in using statistical cut-off points to set competence criteria. ... "). 4 7. /d. at 377. while this is a nuanced point, the choice of terms used here is incorrect. one could argue that all individuals are always autonomous. a judgment of competency deter­ mines whether at a particular point in time an individual is capable of exercising his autonomy in accord with her preferences. regardless of that determination, this individual does not be­ come nonautonomous. this view defines autonomy based both on 1he individual and the choic­ es she makes. see tom l. beauchamp & james f. cjm:.dress, principles of biomedical ennes 38 (5th ed.) (200 i) (discussing the distinction between the autonomous person and au­ tonomous choice). 184 indiana health law review [vol. 6:171 in the case of mental illness where the benefits of particular interventions are questionable and the risks arguably significant, 48 the risk and detriment ofhav­ ing an incompetent person judged competent is more real. although no harm may result from allowing an incompetent patient to decide on issues with "mi­ nimal effect," the decisions regarding interventions for mental illness are rarely with "minimal effect".49 in practice, however, we act as if they were. under the premise of respecting autonomy, courts generally do not question compe­ tency when the mentally ill individual acts in the way that others recommend or expect. 50 instead, judgments of competence for mentally ill persons are mostly triggered when the individual chooses not to act in accordance with the recom­ mended treatment. 51 for many individuals with mental illness, however, the rational choice would seem to be not to medicate given the potential risks of many of the available medical interventions for mental illness. 52 still, the deci48. see infra part ll.b for a discussion of the risks and perceived benefits of interventions for mental illness. 49. see berg, supra note 18, at 377 (implying that competence is ofless importance with issues of minimal effect). 50. the purpose of this argument is not to say that mentally ill individuals can never give informed consent or act autonomously. rather it is to say, that judging informed consent where mental illness is concerned should receive more scrutiny than it does and perhaps that it should be more difficult than it is to presume consent was given and adequately informed. because obtaining invalid consent in this population may be more common than is credited, any threats to informed consent should be minimized, so that the practice does not become even less mea­ ningful than it has already. see infra part m for a discussion of ethical considerations in coer­ cively obtained consent (suggesting that preserving the moral agency of mentally ill patients in part entails respecting decisions regarding bodily integrity that may conflict with societal goals and values). 51. see wenona whitfield, capacity, competency and courts: the illinois experience, 14 wash. u. j.l. pol'y 385, 285 (2004) ("when mental health patients refuse to accept volun­ tary administration of psychotropic medicine, illinois is one of several states that provides for a judicial hearing to determine whether the patient's wishes should be overruled.''). psychotropic medications include those medications that are "capable of affecting the mind, emotions, and behavior; denoting drugs used in the treatment of mental illnesses." stedman's concise medical dictionary for the health professions 817 {4thed. 2001){definingpsychotropic). the decision to refuse medical treatment most commonly invokes a discussion of competency because attempts to involuntarily administer treatment to a competent patient have failed. see generally rogers v. comm'rofdep'tofmental health, 458 n.e.2d 308, 314,321-22 (mass. 1983); opinion of the justices, 465 a2d 484, 489 {n.h. 1983). a determination that a patient is incompetent will allow an institution to forcibly medicate this patient on a theory of perceived patient interests and the patient's own inability to choose the best option. 52. see infra part ii.b for a discussion of the considerations which should be disclosed and the impact that such disclosures might have on the decision to refuse medication. for an in depth discussion of the right to refuse drugs, which is beyond the scope of this discussion. see generally william m. brooks. reevaluating substantive due process as a source of protection for psychiatric patients to refuse drugs, 31lnd. l. rev. 937, 991 {1998) ("no one can serious­ ly dispute that forcing a person diagnosed as mentally ill to accept medication shapes a substan­ tial aspect of the person's life, which abridges a patient's right to bodily autonomy."). the discussion of medication refusal is relevant for the purposes of demonstrating motivations for competency assessments when parties use these assessments to argue against an individual's right to refuse treatment. but, "[t]he logical corollary of the doctrine of informed consent is that the patient generally possesses the right not to consent, that is, to refuse treatment." cruzan v. dir., mo. dep't of health, 497 u.s. 261, 270 (1990). the "right to refuse" cases are also useful 2009] informed consent, mental illness, and moral agency 185 sion to medicate, which may be viewed as the irrational decision, almost never prompts a competency assessment. instead, the competency component of in­ formed consent only appears to come into question when the mentally ill indi­ vidual makes the arguably rational choice not to medicate. this reality makes competence a particularly important component of consent for individuals with mental illness because it can be easily manipulated to find competence when the individual agrees to treatment desired by others and incompetence when such treatment is refused. in many ways, competence is the most important element of informed consent for individuals with mental illness because, when the individual agrees to treatment, the elements of disclosure and voluntariness are not questioned. when the individual refuses treatment, there is no duty to disclose because what might be important to a reasonable person would be irre­ levant to the incompetent individual and treatment under these circumstances is by definition involuntary. thus, these factors seem to receive less consideration in the legal interpretation of informed consent for individuals with mental ill­ ness. nevertheless, they provide other points of vulnerability in applying the doctrine of informed consent to those with mental illness and merit considera­ tion. b. knowing how far the duty to disclose extends becomes especially difficult when dealing with mental illness the requisite knowledge to judge whether a particular individual's con­ sent is informed correlates with the physician • s duty to disclose information in obtaining the consent. this duty can be judged either from the physician's perspective or the patient's perspective. the physician perspective requires physicians to disclose what would be traditionally disclosed by practitioners in similar circumstances, while the patient perspective requires the physician to disclose what a reasonable patient may find material in making a decision under the same circumstances. 53 both formulations contemplate the impossibility of disclosing every possible outcome in any given intervention and both recognize that the physician's duty extends only as far as his own knowledge does. re­ gardless of the perspective from which the disclosure duty is framed, the conse­ quences of these premises are particularly important when considering what to disclose to mentally ill individuals for three reasons. in illuminating the important liberty and privacy issues that create part of the foundation for the informed consent doctrine. see generally brandeis and warren, supra note 10. 53. see supra notes 23-33 and accompanying text (discussing in general the physician's duty to disclose in the process of obtaining informed consent). 186 indiana health law review [vol. 6:111 1. treatments for mental illness are incompletely developed and carry with them the risk of significant adverse effects54 the approach to treating the patient with mental illness is, as a whole, not a precise a science. while there is a substantial degree of variability that ac­ companies the treatment of any condition with medication, in the treatment of mental illness, ''trial-and-error .. is more the norm than the exception. 55 know­ ledge regarding treatment for mental conditions is incomplete largely because knowledge about mental illness is itself incomplete. 56 therefore, it will be dif­ ficult. if not impossible, for the physician to assert that treatment for mental illness will be beneficial in any given case because she simply cannot know this a priori. 51 antipyschotic drugs do not promise to cure mental illness; at best. they offer a reduction in some, but not all debilitating symptoms associated with mental illness. 58 in a substantial number of patients, medication will not pro­ vide any benefit. and rarely will medication provide complete relief. 59 because of the lack of effective interventions in treating mental illness, the physician faces special problems in meeting her duty of disclosure in a meaningful way. the physician will be able technically to meet her duty of disclosure because the duty only expects her to reveal what she knows (and logically cannot expect more); however, while legally appropriate, this still may leave the patient to decide without information that is material to an adequately weighed decision. the high probability and severity of side effects associated with many 54. undoubtedly, for some individuals, phannacologic intervention can be and is the most effective way for them to deal with their mental illness. to the extent that such individuals have given legally valid informed consent, after a consideration of the particularwlnerabilities of the informed consent doctrine in the context of mental illness, these situations are not problematic. this article instead focuses on the concern that if moral agency is conditioned on one's com­ pliance with treatment, the majority of individuals with mental illness will not be provided the opportunity to give valid non-coerced consent to their treatment because of the complexities of the cons~t doctrine in mental illness. see infra part iii. 55. see brooks, supra note 52, at 946 ("physicians must prescribe antipsychotic drugs on a trial and error basis as there is no accurate method of determining how a patient will respond to a particular drug."). 56. see generally mental health, meaning of mental health, in encyclopedia of bioetidcs 1757-65 (stephen g. posted., 3d ed. 2004) (exploring difficulties in defining mental illness}; mentallllness, in encyclopedia of bioe'lliics 1789-1815 (stephen g. posted., 3d ed., 2004) (suggesting that cultural and temporal effects also impact understanding of mental ill­ ness); see also ake v. oklahoma, 470 u.s. 68, 81 (pointing to difficulties with psychiatric diag­ noses); addington v. texas, 441 u.s. 418,429 (1979) (same). 57. there are a number of other conditions in which the physician is uncertain about the expected benefit of a particular intervention and this alone does not invalidate consent. in those cases as well, there is a higher burden of demonstrating that the individual truly understood the risks she was taking relative to the uncertain benefit and made a reasoned decision based on this assessment. in the context of mental illness, this problem is of special concern because the en­ tire informed consent process is more vulnerable and the known risks of most psychotropic me­ dications are substantial. 58. see brooks, supra note 52, at 945-46 (discussing the role and promise of psychotropic medications). 59. /d. at 946 (discussing the role and promise of psychotropic medications). 2009] informed consent, mental illness, and moral agency 187 pharmacologic interventions for mental illness complicates the lack of complete information regarding the nature of mental illness.60 "[i]t is difficult to imagine intrusions on the body that are more significant than the administration of anti­ psychotic and other psychotropic medication. antipsychotic medication is, by definition, mind-altering in nature, and presents a risk of debilitating side ef­ fects that may be permanent.'.61 along with producing general side effects that are common to many pharmacologic interventions, psychotropic medications may also result in potentially long-standing, serious, and even life-threatening side effects. 62 some of the most disturbing symptoms resulting from use of psychotropic medications, particularly antipsychotic agents, are extrapyramidal symptoms, which result from a disturbance of motor function in the brain. 63 the extrapyramidal symptoms can be divided into hyopkinetic or decreased movement disorders and hyperkinetic or increased movement disorders. 64 the hypokinetic disorders associated with psychotropic medications in­ clude akinesia and parkinsonism or decreased speed of movement.65 akinesia produces a clinical picture in which individuals have difficulty initiating movement.66 the presentation is "characterized byunspontaneous speech, apa60. see washington v. harper, 494 u.s. 210,229 (1990)(acknowledgingthepossibility of such dangerous side effects). this article spends much time discussing the nature and con­ sequence of the side effects of psychotropic medications precisely because knowledge of these side effects, coupled with low expectations that a given intervention will be effective, logically supports the notion that a purely rational actor, when considering the pharmacologic interven­ tion in isolation, would likely opt not to medicate. it may be argued that in other conditions, patients choose to attempt interventions which may be considered to have a low probability of success or even judged futile. indeed, in an attempt to relieve certain terminal conditions, par­ ticularly in the field of oncology, some people may choose such interventions even when signif­ icant side effects are possible. these cases demonstrate that it is not necessarily irrational for a person to select an option that has low probability of success and great possibility of significant harm, but these circumstances can be distinguished from the situation of mentally ill patients on at least two grounds: (1) in general, such choices are made when the individual is facing a life terminating condition if some intervention is not selected, and (2) any coercive pressure this potential factor plays in their decision is inherent to the condition itself and not external factors. see supra part ii.c (discussing bow external factors exploiting weaknesses of mentally ill per­ sons may be used to coerce compliance with treatment regimens). 61. the courts have agreed with this viewpoint see harper, 494 u.s. at 229 (recognizing the danger of side effects); see also brooks, supra note 52, at 991; el yn r saks, refusing care:forcedtreatmentand1herightsof1hementallyiil(2002)(discussingthe"mind altering" and "thought suppressing" nature of drugs); george p. smith, ii," just say no!": the right to refuse psychotropic medication in long-term care facilities, 13 annals healrnl. 1, 4 (2004) (addressing the side effects of psychotropic medications). 62. despite the lack of certainty surrounding the benefit of psychotropic medications, they are widely accepted in the psychiatric community. see harper, 494 u.s. at 226 n.9. 63. see chrlstophbr g. goetz, texmook of clinical neurology 289 (2003) [herei­ nafter texmook of neurology] (describing extrapyramidal symptoms as a "class of motor disturbances"). 64. see id. ("movement disorders are clinically characterized by hypokinesia or hyperki­ nesia. j. 65. id. 66. id. (characterizing akinesia as absence of movement). 188 indiana health law review [vol. 6:171 thy and difficulty initiating activities. '.67 parkinsonism can involve akinesia in addition to other features characteristic of parkinson's disease, "mask-like fac[ies ], drooling, muscle stiffness, and rigidity,'a along with a resting tremor and possibly inadequate responses to changes in posture.69 the hyperkinetic disorders associated with psychotropic medications in­ clude akasthesia, dystonia, and tardive dyskenesia. 70 akasthesia is a motor dis­ order characterized by ''uncontrollable physical restlessness, agitation, pacing, anxiety and panic,'' potentially joined by "a constant tapping of feet, alteration of posture ... and an inability to feel comfortable in any position."71 because psychomotor agitation is also a symptom of many psychiatric diagnoses, 72 this presentation may prompt administration of even higher doses of the offending agent, under a false belief that the underlying psychiatric disorder is not ade­ quately managed. 73 dystonia is a spastic muscle reaction. the most common locations for dystonic reactions secondary to psychotropic medications include the eyes, neck, face, and arms.74 dystonic reactions will generally subside when the offending medication is discontinued. 75 the most troubling motor reaction to psychotropic medication is tardive dyskinesia. this disorder is as­ sociated with long term psychotropic medication usage and involves involunta­ ry movements of the muscles of the face, arm, leg, or trunk. 76 67. see theodore vanputten & stephen r. marder, behavioral toxicity of antipsychotic drugs, 48 j. clinical psychiatry 13, 15 (supp. 1987) (describing akinesia). 68. robert plotkin, limiting the therapeutic orgy: mental patients' right to refuse treatment, 72 nwu.l. rev. 461,475 (1978) (explaining the features ofparkinsonism). 69. textbook of neurology, supra note 63, at 280. normally, when a person changes their posture, reflexive mechanisms in the body will cause certain muscle contractions to occur in order to maintain a certain blood pressure. jd loss of initiating movement mechanisms in patients with features ofparkinsonism can result in loss of this postural reflex. jd parkinson­ ism may occur in up to ninety percent of patients on psychotropic medications. brooks, supra note 52, at 948 (quoting dennis e. cichon, the right to "just say no": a history and analysis of the right to refuse antipsychotic drugs, 53 la. l. rev. 283,300 (1992)). 70. texlbook of neurology, supra note 63, at 280. 71. see brooks, supra note 52, at 947. 72. see generally american psychiatric association, diagnostic and statistical manual iv (4th ed. text revision 2000) [hereinafter dsm-iv-tr]. psychomotor agitation may be part multiple diagnoses, including psychotic disorder not otherwise specified, depression with psychotic features, schizophrenia, and bipolar disorder. ld 73. see peter j. weiden, et. al., clinical nonrecognition of neuroleptic-induced move­ ment disorders: a cautionary study. 144 am. j. psychiatry 1148, 1151 (l987)(discussing this trend). 74. brooks, supra note 52, at 948. 75. jd it should be noted that this is still a disabling reaction, and may disappear if the medication is discontinued. this potential relief is irrelevant, however, if an individual expe­ riences the reaction with each medication attempt and there is an expectation that they will re­ main on their medication if it controls the symptoms of their underlying psychiatric disorder regardless of its secondary effects. 76. see dilip v. jeste et al., the biology and experimental treatment of tardive dyski­ nesia and other movement disorder. in 8 american handbook of psychiatry 536, 537 (berger & brodie, eds., 2d ed. 1986) (describing this troubling side effect). upon discontinua­ tion of psychotropic medications, symptoms of tardive dyskinesia may initially worsen. texmook of neurology, supra note 63, at 1228. they may potentially be lessened or re2009] informed consent, mental illness, and moral agency 189 a non-motor related but potentially life-threatening reaction to initiating or increasing psychotropic medications is neuroleptic malignant syndrome. 77 an incompletely understood mechanism mediates this multi-organ syndrome which causes increased temperature, stiffening of muscles, inadequate function­ ing of one part of the nervous system important in maintaining life-sustaining bodily activities, and changes in level of mental status. 78 the unique challenges that diagnosis and treatment of mental illnesses create for the duty to disclose result directly from both the disagreement about the criteria for diagnosis of these conditions and also the varying reports and beliefs regarding the success of various interventions. when examined in the context of the knowledge requirement of informed consent, it is unclear how this information can possibly be conveyed to patients in a useful way to meet the disclosure component of consent because of the lack of certainty regarding the diagnosis of mental illness and the unpredictability of response, it seems on a practical level that interventions in mental illness are experimental in almost every specific instance, even if there is a general consensus that pharmacologic intervention can be effective in treating mental illness. 79 2. the physician perspective standard provides a great deal of deference in disclosure to patients criticisms of the physician's perspective approach to the duty of disclo­ sure are particularly relevant to the community of individuals with mental ill­ ness. one· of the strongest criticisms of the approach is that it will permit a physician to refrain from disclosing information that might be relevant to a par­ ticular patient if it is not customary to do so. 80 with the numerous conse­ quences that can result from treatment with psychotropic medication, it would likely be impossible for any physician to obtain consent for treatment if all polieved by changing to a newer antipsychotic medication with a lower incidence of such effects or by waiting several years after discontinuation of therapy. !d. unfortunately, however, one of the more promising agents for patients who suffer from tardive dyskinesia, clozapine, acts to lower the threshold for seizures in individual patients. !d. at 1286. this may either aggravate existing epilepsy or induce epilepsy de novo. in either case, it replaces one negative effect with another. 77. see textbook of neurology, supra note 63, at 1227; see also brooks, supra note 52, at 950. 78. see textbookofneurology,supranote 63, at 1227 (explaining the features of the syndrome). 79. the ethical principles which inform and argue against medical experimentation in other contexts, especially with vulnerable populations such as children, may help to inform this discussion as well. see holly fernandez lynch, give them what they want? the permissibili­ ty of pediatric placebo-controlled trials requested under the best pharmaceuticals for child­ ren act, 16 annals realm l. 79, 80 (2007) ("[p]ediatric subjects ... are developmentally and legally incapable of providing consent on their own, and thus require more protection from abuse and exploitation in research.''). while competent individuals with mental illness still ought to be able to consent on their own, they warrant similar protection from abuse and exploi­ tation. 80. see supra notes 23-33 and accompanying text (discussing the physician and patient perspective approaches to the duty of disclosure). 190 indiana realm law review [vol. 6:171 tential effects were disclosed. it may therefore become customary to disclose only those most serious or life threatening consequences, when other effects may be perceived as impo$nt by patients. a shift to the patient-centered pers­ pective offers only the illusion of a better information exchange. 81 3. the "patient centered" materiality standard inadequately accounts for variability in symptoms of mental illness focusing on the patient perspective, courts have accepted a materiality standard against which the adequacy of physician disclosure is judged. 82 in­ formation that may be deemed relevant by a ''reasonably prudent patient" under similar circumstances must be disclosed under this standard. 83 seemingly, this should afford improved information exchange between physicians and individ­ uals with mental illness. "reasonable" behavior, however, may differ not only for different mental illnesses and different proposed treatments but for also for different individuals with the same illness. this is a feature not only of the un­ avoidable consequence that different individuals will respond differently to the same treatment but also of the known fact that individuals who can pass a com­ petency evaluation-and who will then be judged by the materiality standard of the reasonably prudent patient with "x" disease-may be impaired to different degrees. 84 because physician judgments regarding the severity of mental illness are fairly rudimentary, absent useful instruments to objectively measure disease severity for mental conditions, patients with mental illness are less likely tore­ ceive the information they need relative to their level of impairment in order to make an informed decision.85 this discrepancy points to another vulnerability in the consent process for treatment of mental illness. 81. see miller, supra note 25 (describing the patient centered view). in addition to the considerations below, a fundamental difficulty in the patient-centered perspective, is that it only requires disclosure of material risks; there is no restriction on how this information will be pre­ sented to the patient. in general, the effective presentation of risks is a necessary component of consent. the physician must be able to judge when a patient needs more or less information in order to make an informed decision. any attempts to script the communication which occurs between a physician and patient will likely be detrimental to the practice of medicine as a whole because they do not appreciate the benefit of the physician-patient relationship in helping the physician to determine what information needs to be disclosed see arthur caplan, abortion politics twist facts in fetal pain laws: proposed bills that address fetal suffering go beyond medical evidence. ms-nbc commentary (nov. 28, 2005), available at http://www. msnbc.msn.com/id/10238840/. still, the presentation of risks and benefits is important. for example, most people will respond more strongly to a potential risk presented as a loss than a potential benefit presented as a gain. in the case of mental illness, then, when the risks are so significant and the benefits unlikely to be significant, the emphasis the physician puts on even material disclosures will undoubtedly influence the patient more so than in other contexts. 82. see chamberlain v. giampapa, 210 f. 3d 154 (3rd cir. 2000) (applying the patient materiality standard). 83. see id. at 161-62 (describing the "reasonably prudent patient" standard). 84. see supra part it.a (underscoring difficulties with competency assessments unique to mental illness). 85. arguably, all persons with medical conditions may be afflicted to varying severity and 2009] informed consent, mental illness, and moral agency 191 c. individuals with mental 0/ness are particularly vulnerable to coercion that may make consent involuntary perhaps the greatest vulnerability, which can be exploited in the consent process, is the requirement that consent be voluntary. while viewpoints vary regarding whether pressured consent can nevertheless be voluntary, legally ef­ fective consent must, by definition, be voluntary. 86 voluntary consent is "con­ sent that is given freely and that has not been coerced. "87 coercion, in its most general form means to compel a particular action by the threat of physical force. 88 taken together then, any consent obtained by an individual threatened with physical force would be invalid. mentally ill individuals often face a choice among several physical threats. absent consent to physical administra­ tion of pharmacologic agents-with all of their attendant risks and uncertain benefits-the mentally individual may be threatened with physical restraints for "behavioral control" or incarceration for acts committed that are the believed result of his mental condition. 89 such choices, undoubtedly weigh heavily into the individual's decision to begin often-lifelong relationships with pharmaco­ logic agents that can wreak havoc on body and mind.90 therefore will require varying degrees of infonnation to make a decision regarding their treat­ ment. 86. see black's law dictionary 255-56 (8th ed. 2005) (defining consent). 87. id. 88. see black's law dictionary 215 (8th ed. 2005) (defining coercion). 89. agreement to pharmacologic treatment may result ftom coercive conditions such as incarceration, institutional release conditioned on compliance, and institutional privileges granted based on compliance. see generally slodov, supra note 1 (suggesting one coercive mechanism by which compliance can be assured). to the extent that these arrangements en­ courage accountability for their condition, such "choices" may actually be thought to present the mentally ill individual the opportunity to demonstrate her moral agency by making the "correct decision" to medicate and avoid future harm. such an expectation, however, actually under­ mines the doctrine of infonned consent, thereby challenging the very autonomy that is requisite to any theory of moral agency. see infra part iii (concluding that coercively obtained consent is also unethical because it undermines autonomy). 90. the view espoused by the american medical association comports with the idea that such ''preferences" appropriately weigh into these decisions. the council writes that ''the deci­ sion to undergo a medical procedure so as to avoid a lengthy incarceration seems neither irra­ tional nor involuntary." ceja report 4-a-98, supra note 19, at 3. under the legal understanding of consent and coercion, such a decision may indeed be rational but is arguably not voluntary. the viewpoint that coercive consent obtained by using the threat oflosing one's freedom (or even moral worth) could be voluntary is somewhat absurd if considered in another context. it would be easy to imagine a law that judges fetuses to be humans. coupled with laws that make killing all humans a crime, such a legal framework would make abortion a crime. according to viewpoints that coercive consent can nevertheless be voluntary consent, this does not invalidate an individual woman's choice of whether to obtain an abortion. she could choose to protect her bodily integrity against the effects of pregnancy. the cost, however, might be her freedom. but views that permit coercive consent could not call this consent any less voluntary than the mentally ill individual whose consent is obtained under threat of detention, restraint, or refusal to allow membership in the moral community absent an agreement to control his illness through medication. both could rank freedom high in their consideration of preferences, and then give consent to something they would otherwise not want-the woman to carrying a child, the mentally ill person to medication with uncertain probability of success and certain probabili­ ty of unwanted side effects. conditioning access to health care on reproductive abstinence is 192 indiana health law review [vol. 6:171 the moral community has the potential to coerce seemingly involuntary consent without the threat of physical force. moral coercion, defined as undue influence, can hold invaluable weight for the mentally ill community.91 among descriptions of mental illness, a recurrent theme emerges--the mentally ill are many times tortured by their desire to make the morally correct choice, despite their performance of the morally incorrect one.92 ''these discrepancies between what one is, what one is brought up to believe is the right way of behaving to­ ward others, and what actually happens during these awful black manias ... are absolute and disturbing beyond description."93 tying one's moral standing to her cooperation with a pharmacologic regimen creates an impermissible undue influence on the capacity to choose, because it ties the decision to medicate to an external goal which drives the decision. 94 without a real choice, the deci­ sion to submit to pharmacologic therapy is involuntary, and informed consent cannot be deemed legally e:ffective.95 similarly coercive. see generally bloche, supra note 38 (making the argument that this type of condition would also be immoral). 91. see black's law dictionary 215 & 1276 (8th ed. 2005); see also o'sullivan & borcherding, supra note 6, at 72 (''many people with mental retardation and mental illness have a great desire to please those in authority."). 92. see generally kay jamison, an unquiet mind (1995); andy behrman, electroboy (2002). 93. jamison, supra note 92, at 120-23. the failure to make the right choice is even more disturbing when the individual realizes that to make the choices he makes, "[he knows] that [he] is sabotaging [himself]". behrman, supra note 92, at 20-23. 94. see blouche, supra note 38, at 247 (explaining that an autonomy-negating external influence is coercive). below, this article considers whether it may be permissible to coerce such cooperation as it may be deemed necessary pending a more appropriate way for society to respond to the needs and results of mental illness; however, to do so under the false premise that this individual has voluntarily consented to something when he was left with no real choice to do otherwise diminishes the value of the informed consent doctrine. 95. the foregoing discussion highlights the difficulty in determining whether informed consent was given for pharmacologic treatment in mental illness. while the problems may ap­ pear to invalidate the doctrine of consent completely as applied to mental illness, this is not a necessary result or the intent of the discussion. there will indeed be some patients who are competent to make decisions given the appropriate amount of education by a health care provid­ er such that information important for this individual is disclosed. furthermore, not all consents to treatment with pharmacologic therapy will be affected by moral coercion or physical coercion that can also serve to invalidate consent. these considerations should be contemplated whenev­ er consent is obtained for treatment of mental illness; if they have not been contemplated, truly informed consent has not been secured. even without consent, it may be ethically and legally justifiable to expect mentally ill individuals to submit to treatment when the criteria for involun­ tary treatment have been met. see supra note 6. 2009] informed consent, mental illness, and moral agency 193 iii. where informed consent is legally ineffective because of coercion, the condidons which made it coercive also make it unethical 96 it is unlikely that any state at this moment in history would attempt to make it a criminal offense for a person to be mentally ill, or a leper, or to be afllicted with ave­ nereal disease. a state might determine that the general health and welfare require that the victims of these and other human afllictions be dealt with by compulsory treatment, involving quarantine, confinement, or seques­ tration. but, in the light of contemporary human know­ ledge, a law which made a criminal offense of such a disease would doubtless be universally thought to be an infliction of cruel and unusual punishment in violation of the eighth and fourteenth amendments.97 such a law would also be unethical. requiring some form of control over men­ tal illness without deeming the illness itself immoral, however, may not be un­ ethical. there are numerous theories that can describe principles for ethically responsible action in the context of medical interventions and ethically respon­ sible behavior by members of the larger moral community. the majority of these theories fall along a continuum from theories that create principles to con­ sider only the self/individual in determining whether a particular intervention is ethical to theories that create principles that the entire moral community should be considered in choosing the appropriate course of action. after briefly ex­ ploring these theories, this article concludes that all either implicitly or expli­ citly mandate respect for autonomy of the individual to whom a particular action is attributed. because failure to obtain valid informed consent under96. while part iii of this article makes the argument that coerced consent in the context of mental illness is unethical, some argue that coercion alone does not imply immorality of an action. see blocuhe, supra note 38, at 240 ("[11he conclusion that an influence method consti­ tutes coercion does not by itself imply that the method is morally wrong."). for the pwposes of this discussion, the terms morality and ethics or moral and ethical choices essentially will be used interchangeably. if those words are understood based on their original derivation, the word morality (root. "more") refers to one's living their life in conjunction with customs or norms, while the word ethical (root. ethos) refers to living one's life in conjunction with principles of reason. a second formulation of the dichotomy considers morality living one's life according to some principle and reserves ethics to refer to those principles tending to lead to a conception of the good. a final distinction suggests that morality refers to an individual's own assessment of right and wrong while ethics refers to the more general principles and concepts utilized in judg­ ing morality. this distinction probably comes closest to the intent with which the words are used here. see robert p. rhodes, healmcarepolitics, poucy, and distributive justice 287 (suny press 1992) ("morality refers to right or wrong behavior consistent with some ethical principles or authority. ethics is a higher abs1ract category, the study of principles :from which moral behavior can be judged."). 97. robinson v. california, 370 u.s. 660,666 (1962). 194 indiana heal til law review [vol. 6:171 mines the autonomy of the mentally ill individual, it also undermines her moral agency. respect for moral agency itself requires that such agency not be condi­ tioned on coercively induced medication compliance. a. informed consent respects the principle of autonomy theories of autonomy are varied, but"[ v ]irtually all theories of autonomy agree that two conditions are essential for autonomy: (1) liberty (independence from controlling influences) and (2) agency (capacity for intentional action)."98 these form the basis for three of the five elements of ethically valid consent: (1) competence, a proxy for "capacity," (2) voluntariness, freedom from "con­ trol,"99 and (3) consent, the "intentional action."11l0 the two remaining ele­ ments-{ 4) disclosure and (5) understanding-refer to informational elements, and are required to deem consent informed. the concept of informed consent, therefore, really respects a more fundamental principle of autonomy. failure to meet the legal elements of consent due to coercion implies a failure to meet the ethical requirements of consent because coercion undermines the autonomy that is requisite to moral theories of consent. conditioning one's moral agency on coercively driven compliance with a treatment regimen essentially reflects dis­ respect for autonomy. 98. beauchamp & childress, supra note 47, at 58. 99. an ethical analysis of the element ofvoluntariness distinguishes between three kinds of pressure on voluntariness: coercion, influence, and manipulation. coercion results from em­ ploying a severe and credible threat for the purposes of controlling another person. "the threat of force used by some police, courts, and hospitals in acts of involuntary commitment for psy­ chiatric treatment is a typical form of coercion." id. at 94. as implied in the term "involuntary commitment," such coercive treatment should not be considered voluntary and consensual. some elements of influence in the ''treatmenf' of psychiatric patients may not rise to the same degree of force as these, but are valid and credible threats utilized to solicit cooperation from a patient, often under the guise of consent. see supra notes 85-94 and accompanying text. these should be considered impermissible pressures that also rise to the level of coercion. manipula­ tion refers to non-coercive influences that in effect convince an individual to do what the indi­ vidual in authority desires. this strategy pretends to respect the individual's capacity to choose but may alter the mix of information available to her such that only one choice is likely. discre­ tion in the disclosure component of consent creates an opportunity for manipulation, e.g. the physician may not disclose certain risks or inflate certain benefits of a particular intervention to make the rational decision appear to be one other than what it actually is. these influences also greatly undermine autonomy and should be dissuaded. the third type of pressure, however, is less likely to undermine autonomy and moral agency. persuasion may actually advance one's moral autonomy by relying on that individual to make decisions guided by reason, although the individual accepts the decision "through the merit of reasons another person advances." see id at 94. in effect, this influence recognizes that the individual's moral agency exists in a moral community with many influences and effects attributed to any particular decision. see infra part lli.c for a consideration of other based ethical theories that may ethically and legally utilize persuasion to help a mentally ill individual make decisions regarding treatment. it should be cautioned, however, that acceptable persuasion rests on the notion that the individual is being made to choose the rational option. because the effects (and limited benefits) of currently available treatments for mentally ill individuals arguably make the choice not to medicate the rational choice, persuasion in the context of current treatment modalities may not be justified. 100. see beauchamp & childress, supra note 47, at 79. 2009] informed consent, mental illness, and moral agency 195 b. theories of biomedical ethics are based on respect for the individual and generally function in concert with autonomy. traditional biomedical ethics principles ofbeneficence, nonmaleficence, justice101 and autonomy promote a view of ethical behavior that respects the individual, and a commitment to either provide benefit to, or at the minimum, not to harm the individua1.102 all of these theories appeal directly or indirectly to the underlying principle of autonomy. 1. beneficence the principle of beneficence holds that in deciding whether a particular biomedical intervention is ethically appropriate, only actions which will result in good for the patient are ethically desirable. 103 because this principle impli­ citly recognizes the value of the individual, ordinarily, beneficence would sup­ port interventions that the individual would also autonomously choose. at times, the principle of beneficence undeniably will conflict with the principle of autonomy. the strong respect for the principle of autonomy, however, general­ ly prohibits making decisions to which an individual has not consented unless the intervention is arguably of immense benefit to the individual and some defi­ ciency of the individual prohibits him from recognizing this benefit and making the rational choice to consent. when the principle of autonomy conflicts with principle of beneficence, then, the principle of autonomy most often prevails.104 given the undeniable risks and questionable benefits of modern medications used to treat mental illness, using coercive measures to induce compliance with medication regimens cannot be concluded to be of benefit to the individual. the principle of beneficence would therefore argue against administration of medication to the patient when valid consent has not been obtained. 2. nonmaleficence the principle ofnonmaleficence argues even more strongly against medi­ cating a mentally ill individual absent valid consent. the principle of nonmalei 0 i. depending on how the concept of justice is framed, it may be considered either a "self' or "other" ethical theory. if determining whether a particular intervention was fair to the individual, justice is applied as a self theory. in theories of distributive justice, the principle is more communitarian in nature, endeavoring to allocate risks and benefits equally in the commu­ nity. 102. for a general discussion of these principles ofbiomedical ethics, see beauchamp & cjdldress, supra note 47, at 57-272 (exploring in depth these principles). 103. see id. at 176 (discussing the beneficence principle). i04. there is a real tension between the principles of autonomy and beneficence in the context of medical treatment but a more detailed treatment here goes beyond of the scope of this discussion. for a more complete consideration of this tension, see generally id. at 176-94 (dis­ cussing the conflict between paternalistic respect for beneficence and respect for autonomy). 196 indiana heal til law review [vol. 6:171 ficence would reject such treatment on two grounds. first. disrespecting autonomy by not seeking valid consent for treatment creates harm. this vi­ olates one formulation of the "do no harm" principle which mandates non­ interference with autonomy.10s second, this principle finds unethical any interven­ tion which threatens physical harm to the individual.106 pharmacologic interven­ tions in mental illness risk certain harm to the patient with uncertain benefit 107 respect for nonmaleficence makes coercively sought compliance impermissible because both the process and the intervention threaten harm to the individual. 3. justice thirdly, the principle of justice argues against coercing compliance. "common to all theories of justice is a minimal formal requirement [that]: equals must be treated equally, and unequals must be treated unequally."108 this principle also argues against ethical acceptance of coercively obtained consent the autonomy of the mentally ill should be interpreted equally to the autonomy of the non-mentally ill, especially if we expect the mentally ill to be moral agents in the same moral community. on this conception of justice, mentally ill individuals ought to be treated equally with respect to the process of consent. moral coercion that impacts the consent process beyond what would be allowed in other contexts would treat this population unequally and would therefore be unethical.109 4. autonomy the final principle of bioemedical ethics is respect for autonomy itself. while there are limitations on the scope of autonomy, modern treatment of in­ dividuals usually affords great deference to this principle. as autonomy under­ lies the entire informed consent doctrine, failure to obtain valid consent. 105. see id. at 115 ("respect for autonomy [is limited to] rules of the form, 'do not inter­ fere with a person's autonomous choices."'). 106. ld. 107. see supra riotes 55-81 (describing the particular difficulties of pharmacologic man­ agement for mental illness). 108. beauchamp&clm..oress,supranote47,at227. whatconstitutesequalityandhow unequals are defined depend on different notions of justice. because we expect individuals with mental illness to be part of the same moral community, however, we must afford the group of individuals with mental illness equal autonomy. in the context of mental illness, equality in decision-making may mandate other distributive justice considerations such as how resources might be allocated to permit equal functioning and decision-making. see id. at 227-50. 109. if anything, the considerations raised in part ll would justify unequal treatment in the opposite direction, namely removing conditions tbat might be coercive in the context of mental illness that might not appear coercive in other situations. permitting greater coercion in the context of mental illness. when the population is especially vulnerable to exploitation, however, goes against this conception of justice. 2009] informed consent, mental illness, and moral agency 197 ultimately undermines autonomy and would therefore be considered unethi­ cal.llo c. beyond traditional principles of biomedical ethics: moral agency in the general community still requires autonomy traditional principles of ethical treatment in the medical context focus on the effect on the individual patient; more general ethical theories judge ethical behavior in contexts beyond the individual person. theories of moral agency in the larger community may sometimes require sacrifice of purely individual in­ terests in order to promote a healthy and safe community. these moral systems may adopt rules for efficiency that do not require a consideration of autonom­ ous decision-making in every instance; however, autonomy underlies the forma­ tion of these background rules. moral theories accounting for community considerations include: deontological theories, utilitarian theories, communita­ rianism, and the ethic of care. classic theories of ethics include deontology and utilitarianism. deonto­ logical theories stem from the kantian philosophy advocating for universal maxims of right or wrong actions. these theories implicitly respect autonomy because the individual must be able to choose to act in accordance with the moral principles advanced in order to be held accountable for his choices. 111 as a moral maxim, utilizing coercion to induce consent would not be desirable. if willed to be a universal law. coercively obtained consent would permit a number of unspeakable results by undermining the individual's ability to choose a course of action. on a kantian theory, then, coercion should not be permitted when obtaining consent. utilitarianism focuses on the individual as a rational actor and asks that the individual act to maximize overall utility. this theory also mimics many of the requirements of autonomous action. the individual must make his choice based on a calculus of benefit and harm attributed to a particular act. because the requirement of choice also imbues this theory, the theory implicitly requires autonomy. 112 ii 0. see supra part ill.a (discussing autonomy as the foundation for the doctrine of in­ formed consent). ill. see generally immanuel kant, groundwork for tile metaphysics of morals (al­ len w. wood, ed. and trans., yale university press 2002). the classic formulation of kant's categorical imperative requires that one acts such that what he wills will become universal law. this formulation recognizes that one's choices should be considered in his larger community. the individual, however, must be able to rationally determine the effect of universalization on any particular act and must be able to choose not to act in such a way in order for him to live according to kant's maxim. these actions require freedom from controlling influences and the capacity to act intentionally, or will his actions. 112. in theory, pure utilitarianism would not find it objectionable in a particular situation to coerce consent from a mentally ill person if utility would be maximized by that action. see gen­ erally john stuart mill, utilitarianism (filiquarian publishing 2007) (1863). this result is what makes pure utilitarian theories unpalatable. while a full consideration of the merits ofutilita198 indiana health law review [vol. 6:171 more recent theories of communitarian ethics and the ethic of care strong­ ly appeal to the individual's standing in a larger moral community.113 the communitarian movement argues that "communal values, the common good, social goals, traditional practices, and cooperative virtues" underlie moral ac­ tion. 114 this model is based on a theory of collective utility. individuals within this community, however, must still be able to conduct themselves freely ac­ cording to these moral norms. autonomy remains important to communitarian conceptions of the good. similar to utilitarian theories, under communitarian theories, coercing consent from mentally ill patients would be ethically permiss­ ible if overall utility would be maximized by such an action. on ftrst approxi­ mation, it may appear that coercive treatment would maximize utility. the general difficulties faced with utilitarian theory in general, however, will also plague this determination. 115 less calculating, utility-maximizing interpretations of relational or "other'' based ethical theories include the feminist ethic of care theory, which focuses on the different philosophy that the caregiving role of should play in moral de­ cisions.116 caregivers, under this role, would share the responsibility of the mentally ill individual to prevent harm to the community as a result of her ill­ ness, without demanding that the individual coercively consent to treatment in order to have moral standing. the accountability theory is arguably a more general formulation of the ethic of care theory, arguing that not only caregiving expectations, but general expectations that result from the status of relationships mandate accountability. we are in general accountable to others with whom we rianism is beyond the scope of this discussion, applied utilitarian theory is generally difficult on an act by act basis, at least partially because of this discomfort. rule utilitarianism attempts to apply the same theory by setting background principles, which if upheld, will maximize the utility of the community. as a general rule, permitting coercion in the consent process would not appear to maximize overall utility. an appropriate rule might be that informed consent should be suspended and individuals with medical conditions held accountable for preventing their ailments from affecting others. such a principle, however, should probably not require more (or a different kind of sacrifice) from one group with illness, than another. for example, when comparing obligations of epileptics to refrain from an action to keep the public relatively safe (e.g. not driving) to the obligation of the mentally ill individual to actively allow something to happen to his body to protect the same interest (e.g. ingesting a medication with known side effects), it would appear that a disproportionate and unnecessary burden is placed on the mental­ ly ill individual. 113. see generally beauchamp & childress, supra note 47, at 33 7-77 (describing differ­ ent moral theories); the "other" or relationship-based mom! theories have some of their philo­ sophical roots in gauthier's description of the collective action problem for moral choices. see generally david gauthier, morals by agreement (1986) (describing a view that a moral community forms collective morals because communities form based upon an agreed basis of cooperation despite the fact that this will not maximize the utility of the individual actor). more recent formulations of relationship-based "other" views reject strict calculation of utility that forms the basis of gauthier's argument. 114. see beauchamp & childress, supra note 47, at 362. this model is designed on a mostly utilitarian theory. 115. see supra note 112 (describing these difficulties). 116. for a general formula of the ethic of care theory, see carol gllligan, in a different voice: psychological theory and women's devewpment (1982). 2009] informed consent, mental illness, and moral agency 199 are in relationships and they are correlatively accountable to and for us.117 this theory would also allow a sharing of responsibility for keeping the risks inhe­ rent to mental illness minimized.113 these responsibility sharing views allow the individual with the mental illness to operate as a member of the moral community without surrendering his autonomy completely.119 community-based theories also afford a location for appropriate persua­ sion, but not coercion, in the informed consent process. moral persuasion, ab­ sent coercion, is not only permissible but may be ethically mandated by communitarian theories. moral persuasion allows responsible individuals to help a mentally ill individual understand the basis for the morally correct choice. 120 when the mentally ill individual is competent to make this choice, but perhaps lacks complete understanding of the rationale for the decision, per­ suasion can be an effective tool in helping the individual realize his moral agency. still, this moral theory relies on the autonomy of the individual. conclusion mentally ill individuals very much want to be members of the moral community in which they live. a mentally ill individual's moral standing in the community, however, does not need to be, and should not be, tied to his condi­ tional acceptance of medication for his condition. coercing consent for treat­ ment in mentally ill patients legally and ethically invalidates informed consent. because autonomy provides the ethical principle driving development of the informed consent doctrine, ineffective consent ultimately undermines autono­ my. recognizing that moral agency implicitly requires autonomy, any action which threatens autonomy also threatens moral agency itself. by applying rela­ tional theories of ethics, however, the individual can operate in a network of individuals who share accountability for her illness, without requiring the indi117. see generally anita l. allen, thb new ethics: a guided tour of 1he 21st century moral landscape 19 (2004). we are generally accountable to the community of which we are a member. arguments otherwise are suspect unless the individual in question is not a member of the moral community in question. 118. if one sees the ethic of care acting coopemtively with the accountability theory, then the accountability of the individual with mental illness to those with whom he shares relations will not necessarily require him to medicate himself in order to be a member of the moral com­ munity. 119. absent consent to medication that has significant adverse effects. the mentally ill indi­ vidual may be accountable for his illness in other ways. for example, the individual who chooses not to medicate may choose to live with a family member or in a group environment, in which he can be monitored for periods of deterioration that may require more careful considera­ tion of that individual's choices. the family member may help the mentally ill individual be accountable by helping him attend therapeutic appointments, by making certain dangerous ac­ tions less possible, or in the extreme form, by restraining the individual who asks to be re­ strained to control his irresistible urges. see michel focault, abnormal: lecrures at 1he college defrance 1974-1974143 (2004). 120. see supra note 94-95 and accompanying text (detailing the desire of individuals with mental illness to make the correct choice). 200 indiana health law review [vol. 6:171 vidual to submit to mental health treatments that may not really be in his best interest. while coercing medical treatment may be necessary in very limited circumstances, 121 it not should be done under a fiction that the individual has consented. society, and the accountable individuals, must instead demonstrate the necessity of the action, and must subsequently afford the individual in ques­ tion due process required for involuntary treatment. medication compliance is likely not a general desire of the moral commu­ nity. rather, it seems to act as a proxy for the ill individual assuming responsi­ bility for his illness and taking measures to reduce its undesirable effects on others. this expectation comports with moral agency, since the individual must respect others in the moral community in order to be part of that community. because there are other ways in which this individual can demonstrate respect for others and accountability for his illness, 122 the individual who chooses these options, though they may be imperfect in practice, should be credited for doing so and afforded a place in the moral community. it is also important to note that consent absent coercion in the mentally ill patient is valid. if proper steps to eliminate the coercive effects of consent are taken, medication compliance may become an effective proxy for accountabili­ ty. the worry about the practice of coercion does not disappear, but its impact is less objectionable when the rational decision absent the coercion would lead to the same result. to clarify, in the context of obtaining consent to medicate mentally ill patients, coercion is a particular worry now because the rational choice of the mentally ill individual given his current treatment options may be not to medicate. when treatment options become significantly improved such that the rational person weighing benefits and risks of any particular medication regimen would logically choose to medicate, then there is less practical worry about whether the additional factors of coercion are also present although eth­ ically, practices that might be ordinarily considered coercive would still be ob­ jectionable, if the individual would arguably make the same decision without the coercive influence, that influence is no longer actually controlling the deci­ sion. thus, if medication compliance is to be restored as a useful proxy to measure moral agency, then developing medications with a better risk to benefit profile should be a major objective supported by the entire moral community. man's awareness of himself and of the world about him 121. it is important to separate arguments oflegal "necessity" from ordinary moral acts and choices of a mentally ill individual. it may in fact be necessary to undermine an individual's autonomy in order to minimize particularly significant untoward effects on others. in such sit­ uations, the ''justice" or "communitarian" accounts of ethics will permit coercive or forcible treatment of mentally ill persons. this, however, should be reserved only for those limited sit­ uations in which this option is the only option to protect the life and/or safety of another or the mentally ill individual himself. to act otherwise fails to recognize the mentally ill individual's moral worth. 122. see supra note 119. even an agreement to be evaluated, withoutsuccumbingtocoer­ cive treatment, demonstrates accountability. 2009] informed consent, mental illness, and moral agency seems to be a steadily expanding one, bringing in its wake an ever large burden of understanding. this bur­ den, then, is to be expected and must not be misinter­ preted. our only rational means for lightening it is more understanding, and appropriate action based on such un­ derstanding.123 201 our failure to better understand the mechanisms of mental illness should not justify failing to afford full moral agency to this population. respecting their moral agency, however, mandates respecting their autonomy. if the reason to be moral is really because we care, then we ought to care about this as much as anything else. 123. thomas szasz, the myth of mental 0/ness, 15 american psychologist 115, 118 (1%0). indiana health law review volume2 dedication william snyder hall: in memorium eleanor d. kinney articles issue 1 genetic discrimination in health insurance robert f. rich, julian ziegler comprehensive legal solutions for a (not so) special problem? hospital chaplaincy under the hipaa privacy rule: stacey a. tovino health care or "just visiting the sick"? creating human embryos for research: emilie w. clemmens a scientist's perspective on managing the legal and ethical issues of pills and needles: involuntarily medicating the julie d. cantor psychotic inmate when execution looms serving economic efficiencies or anticompetitive . julie c. klish purposes? the future of group purchasing organizations and the antitrust safety zone notes prenatal testing gone awry: the birth of a conflict of ethics and liability a chimera in every sense: standard of care for physicians practicing complementary and alternative medicine understanding the disparity in availability of prescription drugs in the united states: compromise may be the answer patient safety or profit: what incentives are blood shield laws and fda regulations creating for the tissue banking industry? 2005 elizabeth a. ackmann j. brad kallmyer natalie j. tanner jason l. williams indiana health law review volume2 2005 editor-in-chief adriane e. siefert executive m111111ging editor jason l. williams executive production editor kendra l. conover executive development editor calvin r. chambers note development editors elizabeth a. ackmann erin m. drummy j. brad kallmyer david j. lichtenberger paula j. beller paul j. carroll joshua a. claybourn cedric a. d hue deborah c. edwards kathryn a. fox c. jason hannagan richelle m. harris brente.hawkins timothy j. hixson meghann e. labadie members executive notes editor shannon l. logsdon executive artkles editors bryon w. miller julia e. ohl articles editors jennifer m. hamilton theodore g. hammond natalie j. tanner cynthia m. vanvooren christopher j. mcelwee kelly a. mackinnon april a. marshall april e. meade travis p. meek tammy r murray jaclyn m. palos chad a. robertson erin w. southwell richard w. swett, jr. robin s. tubesing kristen c. waldman fiiculty advisors lawrence p. wilkins (chair) eleanor d. kinney david orentlicher robert a. katz indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics ofhealth law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care orgapm.,tions, medical-legal research, legal medicine, and food and drug law. the indiana health law review 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york street indianapolis, indiana 46202-3225 for an academic year, the subscription rate for four issues is: domestic, $30; foreign, $35; student, $20 single issue, $l0; survey issue $20 symposium issue, $15 indiana univenity school of law-indianapolis 2004-2005 administrative officers and faculty administrative officers adamw. herbbrt,presidentofthe university. b.a., m.a, university ofsouthem california; ph.d., university ofpittsburgh. charles r. bantz, chancellor, indiana university-purdue university-indianapolis. b.a., m.a., university ofminnesot.a; ph.d., the ohio state university. anthony a tarr, dean and professor of law. b.a., ll.b., university of natal; ll.m., cambridge university; phd., university of canterbury; ph.d., cambridge university. thomas b. allington, associate dean for technology and professor of law. b.s., j.d., university ofnebraska; ll.m., new york university. jeffrey w. grove, associate dean for graduate studies, professor of law, and director, china summer program. ab., juniata college; j.d., george washington university law school. andrewr. kl.ejn, associate dean for academic affairs and paul e. beam professor of law. b.a., university of wisconsin; j.d., emory university school oflaw. cynthia baker, director, program on law and state government. b.a., j.d., valparaiso university. teresa (terri) j. cuellar, director of technology services. b.s., st. bonaventure university, new york. angela m. espada, assistant dean for admissions. j.d., indiana university school of law-bloomington. jo-ann b. feltman, director of administration and finance. b.a., depaul university. claire grove, director of the ll.m. program. b.a., indiana university; j.d., indiana university school of law-indianapolis. patricia kimberly kinney, director of admissions. b.s., purdue university; j.d., indiana university school of law-indianapolis. jonna kane macdougall, assistant dean for external affairs. j.d., indiana university schooloflaw-indianapolu. carol b. neary, director of development. b.a., indiana university. shannon l. williams, director of professional development. b.s., indiana university. faculty cynthiam. adams, clinical associate professor of law. b.a., kentucky wesleyan college; j.d., indiana university school of law-indianapolis. thomas b. allington, associate dean for technology and professor of law. b.s., j.d., university ofnebraska; ll.m., new york university school of law. judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. gerald l. bepko,indiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. frank bowman, m. dale palmer professor of law. b.a., colorado college; j.d., harvard law school. william c. bradford, assistant professor of law. b.a., m.a, university ofmiami; ph.d., northwestern university; j.d., universityofmiami school oflaw; ll.m., harvard law school. karen e. bravo, assistant professor law. b.a., the university of the west indies; j.d., columbia university school oflaw; ll.m., new york university school oflaw. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. chestek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law. daniel h. cole, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school. jeffreyo. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. patjl.n. cox, centennial professor of law. b.s., utah state university; j.d., university of . utah college of law; ll.m., university of virginia school of law .. rojjin kundis craig, associate professor of law. b.a., pomona college; m.a., the johns hopkins university; ph.d., university of california; j.d., lewis and clark law school. kennbm d. crews, associate dean of the faculties for copyright management; samuel r. rosen professor of law; professor of library and information science, and director, center for intellectual property law and innovation. b.a., northwestern university; j.d., washington university school of law; m.l.s., university of california, los angeles; ph.d., university of california, los angeles. james d. dimitri, clinical associate professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer ann drobac, associate professor of law. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. george e. edwards,professoroflaw and director, program in international human rights law. b.a., north carolina state university; j.d., harvard law school. frank emmert, johns. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university of munich law school; ll.m., the university of michigan law school; ph.d., university of maastricht; diploma, european university institute. nicholas georgakopoulos, professor of law. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. jeffreyw. grove, associate dean, professor of law, and director, china summer program. a.b., juniata college; j.d., george washington university law school. frances watson hardy, clinical associate professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. john lawrence hill, professor of law. b.a., northern lllinois university; j.d., ph.d., georgetown university. lawrence a. jegen, lll, thomas f. sheehan professor of tax law and policy. a.b., beloit college; j.d., m.b.a., the university of michigan; ll.m., new york university schooloflaw. henry c. karlson, professor of law. a.b., j.d., ll.m., university of illinois college of law. robert a. katz, associate professor of law. a.b., harvard college; j.d., university of chicago law school. linda kelly-hill, professor of law. b.a., j.d., university of virginia. eleanor d. kinney, hall render professor of law and co-director of the center for law · and health. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university ofnorth carolina. andrew r. klein, associate dean and paul e. beam professor of law. b.a., university of wisconsin; j.d., emory university school oflaw. robert e. lancaster, clinical associate professor of law. b.a., millsaps college; j.d., tulane law school. normanlefstein, professor of law and dean emeritus. ll.b., university oflllinois college of law; ll.m., georgetown university law school. marfa p ab6n l6pez, assistant professor of law and co-director, latin american law program. b.a., princeton university; j.d., university of pennsylvania law school. gerardn.maguocca,associateprofessoroflaw. b.a., stanford unive~sity; j.d., yale law school. allison martin, clinical associate professor law. b.s., j.d., university of illinois. deborah mcgregor, clinical associate professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. mary h. mitchell, alan h. cohen professor of law. a.b., butler university; j.d., cornell law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. james p. nehf, cleon h. foust fellow, professor of law, and director, european law program. b.a., knox college; j.d., university ofnorth carolina law school. david orentlicher, samuel r. rosen professor of law and co-director of the center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical associate professor qf law. b.s., indiana state university; j.d., california western school oflaw. antony paoe, assistant professor of law. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kann.een patchel, a~ociate professor of law. a.b., huntington college; j.d., university ofnorth carolina law school; ll.m., yale law school. florence wagman roisman, michael d. mccormick professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. ruhi'enberg, clinical professor of law and director of legal analysis, research and communication. b.a., mississippi universily for women; j.d., indiana university school of law-indianapolis. joelm. schumm, clinical assistant professoroflaw. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university school of law-indianapolis. anthony a. tarr, dean and professor of law. b.a., ll.b., university of natal; ll.m., cambridge university; ph.d., university of canterbury; ph.d., cambridge university. julie-anne tarr, professor of law. b.a., university ofw'isconsin-madison; j.d., cornell university; ll.m., monash university; ph.d., university ofqueensl.oo, jambs w. torke. carl m. grfl)' professor of law. b.s., j.d., university ofwi~in. lawrence p. wilkins, william r. neale professor of law. b.a., the ohio state university; j.d., capital university law school; ll.m., university of texas school oflaw, lloyd t. wilson, jr., associate professor of law and director, central and eastern european law program. b.a., wabash college; m.a., duke university; j.d., indiana university school oflaw-bloomington. mary t. wou, clinical professor of law and director of clinical programs. b.a., saint xavier college; j.d., upiversity oflowa college of law. r. george wright, michael d. mccormick professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law-indianapolis. eoierlti edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, ul, professor of law emeritus. a.b., j.d., m.a.l.s., the university of michigan. agnes p. barren, associate professor of law emerita. b.s., j.d.,~ university. clyde harrison crockett, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. f alender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school oflaw-indianapolis. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of l(iw emeritus. a.b., bowdoin college; j.d., university of chicago law school. helbn p. garfield, professor of law emerita. b.sj., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university · of pennsylvania law school. william f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university ofmissouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. william andrew kerr, professor of law emeritus. a.b., west university; b.s., duke · university; j.d., ll.m., harvard law school. william e. marsh, professor of law emeritus. b.s., j.d., university ofnebraska. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., university of illinois college oflaw. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school oflaw. draoomir cosanicj.headofreference. b.a., michigan state university; m.i.l.s., university of michigan; j.d., university ofkansas. debradenslaw, reference librarian. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school of law. mary hudson, reference/circulation librarian. b.a., ball state; m.l.s., indiana university. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. chris e. long, catalog librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. . mahnazk. moshfe.gh,acquisition/serials librarian. b.a., national university oflran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy,associatedirectoroflaw library. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyoshi otsu, computer system specialist. a.a., parkland college; a.b., m.s., c.as., university of ffiinois. indiana health law review volume2 issue 1 table of contents william snyder hall: in memorium .......... eleanor d. kinney xv articles genetic discrimination in health insurance comprehensive legal solutions for a (not so) special problem? . . . . . . . . . . . . . . robert f. rich, julian ziegler 1 hospital chaplaincy under the hip aa privacy rule: health care or "just visiting the sick''? ....... stacey a. tovino 49 creating human embryos for research: a scientist's perspective on managing the legal and ethicallssues ............•............ emilie w. clemmens 93 of pills and needles: involuntarily medicating the psychotic inmate when execution looms . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . • . julie d. cantor 117 serving economic efficiencies or anticompetitive purposes? the future of group purchasing organizations and the antitrust safety zone ....................... julie c. klish 171 notes prenatal testing gone awry: the birth of a conflict of ethics and liability ................... elizabeth a. ackmann 199 a chimera in every sense: standard of care for physicians practicing complementary and alternative medicine ............................... j. brad kallmyer 225 understanding the disparity in availability ofprescription drugs in the united states: compromise may be the answer .......................... natalie j. tanner 261 patient safety or profit: what incentives are blood shield laws and fda regulations creating for the tissue banking industry? . . . . . . . . . . . . . . . . . . . . . . jason l. williams 295 2005 center for studying health system change the mission of the center for studying health system change ("hsc") is to inform health care decision makers about changes in the health care system at both the local and national levels and the effects of such changes on people. hsc seeks to provide objective, incisive analyses that lead to sound policy and management decisions, with the ultimate goal of improving the health of the american public. hsc is a nonpartisan policy research organization located in washington, d.c. hsc designs and conducts studies focused on the u.s. health care system to inform the thinking and decisions of policy makers in government and private industry. in addition to this applied use, hsc studies contribute more broadly to the body ofhealth care policy research that enables decision makers to understand change and the national and local market forces driving that change. issue brief (102), as well as others focused on timely and important health care related topics, are available for download on the center for studying health system change's website: http://www.hschange.com. can money buy quality? physician response to pay for performance thomas bodenheimer jessica h. may robert a. berenson jennifer coughlan introduction while pay for performance ("p4p") has created a nationwide buzz among health plans, physicians and hospitals, most p4p initiatives are still on the drawing board, according to findings from the center for studying health system change's ("hsc") 2005 site visits to twelve nationally representative communities.1 hsc focused on performance-based payment for physicians, finding that only two hsc communities--orange county, calif., and boston-have significant physician p4p programs. in the other ten communities, where almost no physicians have received quality-related payments to date, physician attitudes about p4p ranged from skeptical to hostile. p4p, a concept best suited to larger physician groups, may be difficult to implement in markets dominated by small physician practices. in spite of substantial barriers to initiating performance-related payment for physicians, most large health plans and medicare are planning p4p programs. i. pay for performance: lots of buzz, little action under existing payment systems, physicians typically receive the same payment regardless of the quality of the care provided to patients. to alter this equation, health plans and employers have embraced the idea of paying for performance. typically, p4p programs refer to payment arrangements that offer financial rewards to physicians meeting specific goals, such as provision 1. data source. every two years, hsc conducts site visits in twelve nationally representative communities as part of the community tracking study to interview health care leaders about the local health care market and how it has changed. the communities are boston; cleveland; greenville, s.c.; indianapolis; lansing, mich.; little rock, ark.; miami; northern new jersey; orange county, calif.; phoenix; seattle; and syracuse, n.y. from january through june 2005, hsc interviewed 30 health plans and 19 physician organizations in the 12 hsc communities about p4p, including discussions with leaders of three health plans and three large physician organizations in orange county and with leaders of three health plans, two integrated delivery systems and two independent physician organizations in boston. 446 indiana health law review [vol. 3:443 of certain preventive care, patient satisfaction, acquisition of information technology ("it"} and cost containment. 2 only two ofhsc's twelve communities-orange county, calif., and boston-have significant p4p programs for physicians. in the other ten hsc communities, p4p programs targeting physicians are either minimal or nonexistent. orange county and boston are early p4p adopters in part because many physicians in these sites are organized into large medical groups, integrated systems or independent practice associations ("ip as''). p4p is more difficult to implement in small physician practices that lack the resources and infrastructure to manage care systematically and track performance data. in all twelve markets, p4p has become a signifieant topic of discussion among health plan and physician leaders. thus far, however, in most areas of the country, few performance-based dollars are flowing to physicians. h. p4p approaches vary the design of pay-for-performance programs can vary greatly. the following describe the main ways p4p programs are structured: • physician organizations pay their individual physicians bonuses for improved quality measures, without health plan involvement. • employers pay individual physicians for improved performance. the bridges to excellence program, sponsored by a few large employers, has instituted this model in boston and three other communities. 3 • individual health plans or medicare pay individual physicians for improved performance. physicians are rewarded only for the small number of patients with a particular medical condition who are enrollees of the sponsoring health plan, making these programs of limited interest-and small monetary reward-to physicians. • individual health plans or medicare pay performance bonuses to physician organizations rather than to individual physicians. the physician organization may 2. bradley c. strunk & robert e. hurley, paying/or quality: health plans try carrots instead of sticks, hsc brief no. 82, ci'r. srunying iiealm sys. change (may 2004), bttp://bschange.orgfcontent/675/ (last visited may 17, 2006). 3. bridges to excellence, ge, ford, ups. p&g, verizon, others back new pay-for­ quality initiative for physicians, http://www.bridgestoexcellence.org/news/pr_l.htm (last visited may 17, 2006). 2006] physician response to pa yfor performance invest the bonus money in quality enhancement and/or distribute the money to member physicians. • health plans band together to coordinate payment to physician organizations for improved performance. this is the model pioneered by california's integrated healthcare association ("iha").4 iii. orange county, california: show me the money 447 in late. 2004, major california health plans, in a relatively organized effort, paid physician organizations about $40 million in performance"based bonuses. the physician organizations received funds for demonstrating improved clinical care (cancer screening, childhood immunizations, management of asthma, diabetes and cholesterol), patient satisfaction and development of information technology. physician organizations distributed a substantial amount of the money to individual physicians. california's effort is led by the integrated healthcare association, representing employers, health plans, health systems and the california association of physician groups.5 iha launched its pay-for-performance program in 2002 with a set of uniform performance measures. seven health plans and more than 200 physician organizations involving 35,000 physicians participate in the iha program, which is for hmo enrollees. plans use the same performance measures but differ in how bonus payments are determined. separate from iha, blue shield of california plans to roll out p4p programs for its ppo products in the near future, while blue cross of california is piloting a p4p ppo program that it expects to expand statewide over the next year. iha measured 2002 baseline data for physician group performance. payments in 2004 were based on performance in 2003. while there was wide variation among physician organizations, 2003 performance overall improved compared with 2002.6 performance measures can be derived from health plans' claims data or from data gathered by physician group clinical data repositories. the three largest physician organizations in orange county received substantial sums in the 2004 p4p payout and distributed a large portion of that 4, integrated healthcare association, california health plans announce first statewide, multi-plan initiative to reward physician groups for quality care, http://www.iha.org/011502.htm (last visited may 17, 2006). 5. cheryl l. damberg et al.,payingfor performance: implementing a statewide project in california, 14 quality mgmt. in health care 66, 66-79 (2005). 6. integrated healthcare association, iha program's first year and test year comparison shows increased cancer screening and immunizations, http://www.iha.org/ (last visited may 17, 2006). 448 indiana health law review (vol. 3:443 money to their physician members. some individual physicians in these groups received bonuses of$5,000 to $10,000. all three organizations had paid their physicians quality-based bonuses prior to the iha program. the health plan p4p money was added to already-existing bonus pools, often resulting in larger bonuses for frontline physicians. medical directors are more enthusiastic about p4p than frontline physicians, who become more interested when they see real dollars at stake. because payments come to medical groups rather than to individual physicians, medical groups have invested some p4p dollars in internal systems to improve performance and data collection, in addition to distributing the money to frontline physicians. one group distributed fifty percent of the money to physicians, while two groups distributed more than what they received in p4p payment to physicians, as new p4p payments were added to existing bonuses derived from other sources. overall, orange county shows that to gain physician acceptance, the first p (pay) in p4p is the key to success. despite the monetary benefit, physicians continue to have concerns about p4p. a key concern among physician organizations is the addition of quality measures by some plans, above and beyond the standard iha measures, adding to the reporting burden. leaders also worry that iha is adding measures without adding money, increasing the work/reward ratio. doctors with poor quality scores tend to blame noncompliant patients. leaders recognize that, thus far, quality improvements reported by iha are mainly improvements in documentation rather than in care itself. many medical leaders and frontline physicians believe that p4p payments are not new dollars, but represent a zero-sum game-a redistribution of existing payments. one respondent believed that health plans would reduce capitation payments to physician groups to allow p4p payouts. one health plan leader agreed that p4p payments represent a redistribution of payments, while another said the payments do represent new money. a barrier to success is physician mistrust of health-plan-generated performance data. physician organizations spend large sums to produce their own data, which favors sophisticated groups with clinical it capability. moreover, since large physician groups have funds for quality-enhancing processes, p4p could widen a quality gap between larger and smaller physician organizations. health plan executives affirmed that the money is going to larger and better-run medical groups and that smaller practices lack the infrastructure to make the program work. iv. boston p4p targets efficiency in boston, the other hsc community with an established p4p environment, the three largest health plans include p4p arrangements in contracts with integrated delivery systems. plans also have organized p4p programs for physicians practicing in groups and independently. 2006] physician response to pay for performance 449 in contrast to california's iha, which pays bonuses for improved clinical quality, patient satisfaction and it development, some boston health plans also target a portion ofp4p money for cost-containment measures, such as percentage of prescriptions that are generic, utilization of expensive imaging services or hospitalization rates. in boston, p4p payments are calculated from health plan claims data, chart review and provider-based registries or attestations. while funds in california's iha program are paid as a bonus on top of hmo capitation payments from health plans to physician organizations, boston's p4p model includes both hmo and ppo products and the self­ insured market. the adoption of pay-for-performance programs accompanied a significant change in physician payment methodology. as the use of capitation-'-or fixed per-member, per-month payments-to pay boston physicians declined, performance-based payments became part of a revived fee-for-service reimbursement method. at blue cross blue cross blue shield ofmassachusetts, ninety-eight percent of the primary care physicians and over eighty percent of specialists in their managed care network are contracted under a p4p model. boston's p4p efforts include both large physician groups and small physician practices. in addition to the p4p activities of the three major health plans, some large employers are paying individual physicians quality-based bonuses under the bridges to excellence program. frontline physician awareness of p4p is limited; the concept is only beginning to "make its way out of boardrooms into office practices," according to one respondent. frontline physicians seem more concerned about the stresses of medical practice than dollars. "most of the rank and file is so busy trying to keep up with practicing medicine that they are not paying attention," according to a physician respondent. a concern of frontline physicians is that p4p means a little more money and a lot more work. improving performance often involves identifying patients who are not receiving recommended care, such as mammograms or diabetes monitoring tests, and getting them to obtain needed tests. according to physician leaders, health plan p4p contracts tend to withhold about ten percent of reimbursement, which then gets paid to the practice if performance targets are met. their view is that additional money has not entered the reimbursement stream, a view disputed by at least one health plan. physician leaders worry that the amount of money required to make quality improvements may exceed the performance-based bonuses coming from health plans. mirroring the situation in california, small physician practices lack the infrastructure to make and document quality improvements, a situation that could widen the quality gap in favor of large groups. with p4p in boston facing the additional barrier of no standardization of performance measures across insurers, the massachusetts health quality partners coalition is working to unify quality goals. however, physician 450 indiana heal til law review [vol. 3:443 organization medical directors-who overall embrace p4p-remainconcerned about the lack of a unified p4p effort. as one physician leader explained, "[y]ou can perhaps get a physician to engage with one program, but once you introduce three programs, you get zero engagement with all three. •• v. physicians: supporters, skeptics and resisters physicians in the twelve hsc communities are divided among p4p supporters, skeptics-wait-and-seers-and resisters. in several communities, physician leaders are concerned that the amount of money at stake will neither justify extra work for frontline physicians nor cover extra e~penses of physician organizations. physicians often believe that health plans are not putting additional dollars into p4p, but are taking money from some providers to pay others. p4p opponents may see the programs as ''no pay for no performance"-a health plan strategy to pay physicians less. some physician leaders are getting ready for health plans in their area to roll out p4p programs. others are pressuring plans to get p4p going. yet others refuse to sign health plan contracts with performance-based payment clauses. physicians in one hsc community complained to their medical society, which forced a health plan to retract its p4p plan. one academic health system objected to p4p, arguing that academic physicians do not need money as an incentive to practice high-quality medicine. while frontline physician attitudes toward p4p vary widely, many physician leaders find p4p acceptable if all health plans have the same program. the prevailing model of physicians facing different measures and rules from different plans is seen as an untenable option. vi. p4p: will it spread? while many health plans intend to implement p4p, the barriers, as enumerated by plan executives, are considerable. for each health plan to have its own measures, rules, payment method and payment target (physician groups, individual physicians, primary care physicians, specialists) creates major administrative hassles. in many markets, most physicians do not belong to physician organizations. in those cases, the numbers of patients with a particular condition enrolled in a particular health plan seeing a particular physician are so small that quality measurement is virtually meaningless and payments per physician will be too small to gain physician acceptance and influence practice patterns. physician acceptance likely will be determined by the extent to which health plans commit new funds to reward improved quality. in a 2004 report, the american medical association echoed physician discomfort, writing that 2006] physician response to pay for performance 451 p4p is a ''ts\mami building offshore in a sea of stakeholder unrest, threatening those who are not prepared. "7 p4p has flourished in california because visionary leaders brought health plans to the table and because california has a history of strong physician organizations, some of which already paid quality bonuses to their physicians. boston also has a tradition of large physician groups with a focus on quality. these conditions do not exist in most health care markets. adoption ofp4p will accelerate if mandated by government programs. in early 2005, the centers for medicare and medicaid services (''cms") launched a p4p demonstration project; ten physician group practices will receive extra medieare · payments based on quality measures and cost reduction. cms has expressed support for congressional efforts to integrate p4p into medicare physician paymeilts. should medicare adopt p4p, private plans and medicaid programs oould. well decide to adopt medicare's measures, which in turn would reduce the problem oflack of standardization. whether physicians like it or not, if the giant payers decide to put money into p4p, it will happen. vll. policy implications what do the early observations on physicians' response to p4p tell policy makers? p4p thus far is a program for larger medical groups, and p4p has not yet touched the majority of the nation's medical practices, which have fewer than five physicians. in at least one area-preventive services for medicare patients-quality in small practices is inferior to that in larger groups.8 to the extent that improved performance requires data repositories, chronic illness registries and other quality-enhancing innovations, small physician practices will not be able to keep up with larger groups. a danger lurks that a gap will widen between larger high-quality groups and smaller lower-quality practices. on the other hand, p4p could become a catalyst for physicians to join larger groups that can make the investments necessary to improve performance and reap p4p funds. 7. california healthline, american medical association issues report to member physicians on pay for performance, http://www.califomiahealthline.orgfmdex.cfm?action =dspltem&itemid=107919&classcd=cl351 (last visited may 17, 2006). 8. hongmai h. pham et al., delivery of preventive services to older adults by primary care physicians, 294 jama 473, 473-481 (2005). the "shared accountability" approach to physician payment: four options for developing accountable care organizations jackson williams, j.d., m.p.a.* i. introduction ............................................................................... 186 ii. background ................................................................................ 187 ill. performance criteria and evaluation ................................. 192 iv. making the system work: tools at doctors' disposal .... 197 v. four models of shared accountabilit¥ ............................... 203 a. state level ............................................................................... 204 b. local level: extended hospital medial staff !multi-specialty group practice ........................................................................ 206 c. insurer-convened aco ........................................................... 210 d. a "competitive dynamic" approach to updates .................... 211 vi. conflicts likely to arise in a shared accountability regime ........................................................................................... 217 vii. conclusion .................................................................................. 221 abstract as policymakers confront the failure of fee-for-service medicine to properly align incentives for quality and efficiency, a "shared accountabili­ ty" approach to physician payment has emerged. the newly conceived "accountable care organization" would create "virtual" integrated delivery systems, while maintaining the fee-for-service (ffs) system. this would be accomplished by grouping doctors and hospitals together into discrete pay­ ment pools, through which collective performance could be measured and rewarded as a unit. this paper explores the concept of shared accountability in depth by attempting to flesh out possible mechanisms by which it could operate within the medicare program and how provider incentives might be altered to encourage efficiency and quality. it presents four possible policy options for medicare. it forecasts the conflicts and challenges likely to emerge in a shared accountability regime. the concluding comments assess how the accountable care organization concept addresses some major crit­ icisms of the medicare program. * j.d., loyola university of chicago school of law; m.p.a., governors state uni" versity; b.a., university of illinois. the author has worked on health care issues for public citizen and aarp, and he served as one of the national association commissioners' funded consumer representatives. 186 indiana health law review [vol. 7:185 i. introduction few problems vex health care policymakers more than the failure of fee-for-service medicine to properly align incentives for quality and effi­ ciency. at one time, many pinned their hopes on a system of "managed competition" in which health plans-ideally, integrated delivery systems­ would be held accountable for care.1 following the managed care backlash, policymakers began exploring rudimentary forms of "pay-for­ performance," in which individual providers earn bonuses for achieving, or at least reporting, certain quality measures.2 now, a third-wave approach has emerged, advanced by dartmouth researchers, an institute of medicine committee, and several medicare payment advisory commission members. this "shared accountability" approach would create "virtual" integrated delivery systems, while maintaining the fee-for-service (ffs) system. this would be accomplished by grouping doctors and hospitals together into dis­ crete payment pools, through which collective performance could be re­ warded as a unit. this paper explores the concept of shared accountability in depth by attempting to flesh out possible mechanisms by which it could operate with­ in the medicare program, and how provider incentives might be altered to encourage efficiency and quality. part ii of the paper reviews the literature in which the shared accountability concept was first articulated. part iii discusses possible performance goals that could be rewarded in such a sys­ tem. part n discusses the techniques that doctors could use to achieve those goals when grouped into an accountable care organization. part v looks at four possible permutations of a shared accountability regime in medicare. the first two envision a congressional mandate as­ signing doctors to some type of accountable care organization ("aco") at either the ( 1) state or (2) local level, enforced by target pool mechanisms similar to the sustainable growth rate (sgr) system.3 the idea of local a cos contemplates an initial assignment of physicians that assumes they are members of an "extended hospital medical staff," but would permit doc­ tors to choose a different aco, either at a different hospital or a free­ standing aco resembling a multi-specialty group practice. a third model 1. alain c. enthoven, market forces and efficient health care systems, 23 health affairs 25, 26 (2004) (citing alain c. enthoven, the history and principles of managed competition, 1993 health affairs supp. 24-48). 2. meredith b. rosenthal & r. adams dudley, pay-for-performance: will the latest payment trend improve care? 297 jama 740, 740 (2007). 3. 42 uos.c. § 1395w-4 (2009) (establishing the sgr, which sets a target for physi­ cian expenditures permitted to grow with national income and expansion of services to bene­ ficiaries. in the event that expenditures exceed the target, the conversion factor used to calculate physician reimbursements under the fee schedule is reduced. if expenditures are below the target, the conversion factor is increased. this paper will make reference to this method of updating fees in the ensuing discussion of policy options). 2010] "shared accountabit..ity., approach 187 envisions voluntary acos being convened by insurers, a possibility sug­ gested in the institute of medicine's pay for performance report.4 a final set of models envisions milder, incremental versions in which doctors might be encouraged to collectively pursue efficiency and quality measures with­ out the imposition of any formal framework. this section includes discus­ sion of two new obama administration initiatives that may nudge physicians toward shared accountability arrangements. part vi discusses the conflicts and challenges likely to emerge in a shared accountability regime. the concluding comments assess how shared accountability proposals address some major criticisms of the medicare program. fl. background the rationale for pursuing a shared accountability approach is well stated by the institute of medicine in the introduction to its report on pay­ for-performance, rewarding provider performance: realigning incentives in medicare: the current medicare fee-for-service payment system is unlikely to promote quality improvement because it tends to reward excessive use of services; high-cost, complex. procedures; and lower-quality care. through bundled and prospective payment arrangements for institutions, medicare has attempted to create incen­ tives for efficiencies, but significant price and pay­ ment distortions persist. services that contribute greatly to high-quality care that are laboror time-intensive and rely less on tech­ nical resources, such as patient education in self­ management of chronic conditions and care coordina­ tion, tend to be undervalued and are not adequately reflected in current payment arrangements. little em­ phasis is placed on efficiency (achieving high clinical quality with a given amount of resources). the lack of incentives for comprehensive, coordinated care dis­ courages services targeting early intervention and prevention that can ultimately reduce the use of ex­ pensive services, such as avoidable hospitalizations. providers often miss opportunities for collaboration 4. institute of medicine, rewarding provider performance: aligning incentives in medicare (national academies press 2007). 188 indiana healm law review since the payment system rewards neither team man­ agement nor the integration of services, across care • 5 settmgs. . [vol. 7:185 over the past two years, an increasing number of health policy experts have called for providers' "assum[ption of] 'shared accountability;".c> "band[ing] together into organizations-whether traditional or virtual;"7 "develop[ment of] integrated care networks;'.s or other mechanisms impos­ ing accountability for hand-offs, care transitions, referrals to other provid­ ers, and the long-term health status of patients, not simply for the care that an individual professional delivers during a particular episode of illness. all of these commentators contemplate joint accountability between physi­ cians and hospitals, despite the fact that fee-for-service medicare program separates these, two parties into separate payment "silos." the foundation for the shared accountability approach emerged almost simultaneously from three sources: • in its august 2006 report, the institute of medicine acknowledged that early pay-for-performance efforts would be provider-specific, but stressed that eventually, payment incentives sho~ld be struc­ tured to "stimulate collaboration and shared ac(x)untability among providers across care settings for better patient-centered health out­ comes."9 it went on to call for "longitudinal, population-based measures that foster shared accountability of providers."10 noting the difficulty of measuring an individual physician's performance, . it proposed exploration of what it called "virtual groups~'11 as the unit to be measured. • in a january 2007 health affairs article, elliott fisher and colleagues argued that medicare beneficiaries receive most of their care from relatively coherent local delivery systems comprising physicians and the hospitals where they work or. ad­ mit their patients. efforts to create accountable care organizations at this level-the extended hospital 5. id. at4. 6. national commiti'ee for quality healthcare, ceo survival guide: pay for performance43 (2006 ed.), available at http://www.leapfroggroup.org/media/filel hospitalceoguideto p4p.pdf(last visited may 15, 2010). 7. a high peiformance hemth system for the united states: an ambitious agenda for the next president. the common fund. nov. 2007. at 19. 8. hoangmai h .. pham & paul b. ginsburg, unhealthy trends: the future of physi­ cian services,26 health affairs 1586,1596 (2007). 9. insti1ute of medicine, supra note 4, at 8. 10. /d. at 18. ii. id. at lis. 2010] "shared accountability" approach medical staff..:....ooserve consideration as a potential means of improving the quality and lowering the cost ofcare.12 189 · the article argued that creation of acos would allow better per­ formance measurement, encourage reduction of excess capacity, and aggregate providers into units with the financial wherewithal to invest in health information technology or other quality initiatives. • in a march 2007 report to congress, the medicare payment advi­ sory committee sketched out an "alternate path" to physician pay­ ment, one that ·respects the diversity of the nation and its health care system, [that would] involve[] setting tar­ gets for geographic units and then permitting the ful­ lest possible array of ·alternative-and voluntary­ organizational approaches within that geographic framework. in some geographic areas, acos may take the lead in organizing the effort to lower costs and improve quality... in some cases, state or local governments, medical societies, or others may play a role.13 this report emphasized "shared savings"-warding physicians bo­ nuses when good preventive care averts more expensive acute care downstream--as driving re-aligned incentives for efficiency. one common thread linking these three sources is fisher, who ad­ dressed the medp ac meeting at which the term "accountable care organi­ zation" was coined and who served as a member of and spokesperson for the institute of medicine's advisory subcommittee on pay for perfor­ mance. fisher is associated with the dartmouth atlas project and that work very much informs the rationale for the shared accountability approach. re­ searchers at dartmouth have documented wide geographic variations in the quality and efficiency of american health care.14 they have shown that 12. elliott s. fisher, et al., creating accountable care organizations: the extended hospital medical staff, 26 healm: affairs w44, w44 (2007) [hereinafter fisher, et al., creating accountable care organizations]. 13. medicare payment advisory commission, report to tile congress: assessing alternatives to the sustainable growm: rate system 188 (march 2007), available at http://www.medpac.gov/d~ts/mal07 _ sgr_maridated_ report. pdf (last visited may 15, 2010) [hereinafter medicare payment advisory commission, assessing alternatives]. 14. see elliott fisher & david wennberg, variations in the longitudinal efficiency of academic medical centers 2004 healm: affairs suppl. web exclusives var19-32, 190 indianahealtii law review· [vol. 7:185 fee-for-service medicine can and does produce high-quality, highly efficient health care in certain regions; but also tha!; in most regions, that level of care does not prevail. 15 · another common thread is the opinion shared by many health policy experts that integrated delivery systems--comprised of hospitals and multi­ specialty group physician practices--deliver better, more efficient care/6 and that the dynamics prevailing in such organizations might be replicated on a ''virtual" basis. the accountable care organization superficially resembles indepen­ dent practice associations and physician hospital organizations, entities that sprang into being during the heyday of managed care.17 the aco is seen as having the potential to harness some of the positive characteristics of managed care-such as a measure of financial risk assumed by physi­ cians, the ability to coordinate care, and the infrastructure of an integrated delivery system-without the negative characteristics, such as a loss of physician autonomy, potentially harmful financial risk to physicians, or in­ centives to stint on care.18 this is because it remains a fee-for-service sys­ tem, retaining independent proprietorships, and any financial incentives to stint on care can be counterbalanced, or outweighed, by incentives to im­ prove patient outcomes. unlike the ip a and pho, the aco need not be a formal partnership or corporate entity; all that is necessary is that a pool be delineated in medi­ care's administrative structure that allows savings based upon efficiency or higher-quality care to be shared by the accountable physicians, or that per­ mits bonuses to be added to the pool. the table below shows bow the shared accountability paradigm is in­ tended to occupy a middle ground between the unbridled autonomy of fee­ for-service medicine and the strictures of managed care: http://content.healthaffairs.org/cgilcontent/abstractlhlthaff.var.l9vl. 15. id. at v ar25. 16. see, e.g., laura tollen, physician organization in relation to quali'ly and efficiency of care: a syntliesis of recent literature, the commonwealth fund (2008), available at http://www.commonwealthfund.org/-/media!files/publications/fund% 20report/2008/apr/ . physiciano/o200rganization%20in%20relation%20too/o20quality%20 and%20e:fficiencyc'/o20of%20 care%200/o20a%20synthesis%20of%20recent%20literatu /tollen_physician_org_quality_ e:fficiency_l121%20pdf.pdf(last visited may 15, 2010). 17. stephen m. shortell & lawrence p. casalino, health care reform requires ac­ countable care system, 300 jama 95 (2008). arguably, the aco concept also encom­ passes multi-specialty group physician practices contracting with blue cross/blue shield of massachusetts pursuant to its "alternative quality contract" program, which combines a "global payment structure" with "incentive payouts" for surpassing quality thresholds. see bluecross blueshield association, changing incentives to promote better care, http://www.bcbs.com/issues/ uninsuredlblue-cross-blue-shield-of-mass.html?templatename =template:.28719196&print=t (last visited july 30, 2008). 18. allan h. goroll, et al., fundamental reform of payment for adult primary care: comprehensive payment for comprehensive care. 22 j. of gen. internal med. 410, 41314(2007). 2010] "shared accountability" approach 191 characteristics of physician payment systems dimension fee for shared managed care service accountability doctors' minimal possible possible loss of financial risk negative update withheld for quality and to reimbursement efficiency of reimbursement care schedule doctor minimal constraint by constraint by autonomy constraint, peer pressure utilization review although (and by superiors in tiering and staff model hmo) profiling are potential checks doctor's greater efficient lower utilization, financial utilization, utilization with potential for incentive with potential stinting on care for over-use objective of to earn target to replicate the to manage care in organizing income quality and accordance with delivery efficiency organization's system prevailing in principles ffs medicine high-performing regions locus of individual accountable health plan accountability provider care organization to succeed in providing appropriate care to beneficiaries, a shared ac­ countability regime must be precisely calibrated to achieve efficiency, not stinginess; to produce quality outcomes, not gaming; to be cooperative without being exclusive; and above all, to be perceived as fair by both pa­ tients and providers. sufficient financial rewards must be available to spur investments of doctors' time and money and to provoke collaboration with colleagues-and uncomfortable confrontations when necessary. the possi­ bility of unintended consequences would be daunting if not for the unac­ ceptably poor performance of the current fee-for-service system and the largely unsatisfactory experience with its polar opposite, capitation.19 19. see, e.g., toby gosden, et al, capitation, salary, fee-for-service and m1xed systems of payment: effects on the behaviour of prlmary care physicians, (the cochrane collaboration ed., john wiley & sons, ltd. 2006) (2006), available at http:// 192 indiana health law review [vol. 7:185 beyond addressing the deficiencies of fee-jor-service and capitated medical practice, the accountable care organization also holds promise for achieving larger goals, such as improving the health of populations, as op­ posed to just individual patients20 and promoting better management of medical resources in a health care system thought to be inefficient and wasteful.21 ill. performance criteria and evaluation the idea of an accountable care organization begs two threshold questions: accountable for what and accountable to whom? the three pay­ for-performance goals identified by the institute of medicin~fficiency, clinical quality, and patient-centerednessprovide a good starting point for discussion of what a unit would be accountable for (discussion of to whom the unit is accountable is saved for later). a shared accountability regime envisions a population of medicare beneficiaries as the unit of anal­ ysis for assessing performance on the three dimensions. using a population as the unit of analysis provides a much richer basis for measuring perfor­ mance than the individual provider or patient. population-level quality measures may include outcome measures, where outcomes, not process compliance, constitute the value sought by the medicare program and its beneficiaries. outcome measures at the level of the individual physician are for the most part impracticable, due to the small number of cases involved. at the population level, however, outcome measures can be scientifically valid and fair when the unit being measured has the ability to act collectively to im­ prove performance. as fisher and colleagues note, "implementation of per­ formance measurement at this level could begin nationwide in relatively short order, especially when compared with the challenges of measurement within physicians' offices."'22 this is because a wealth of populationand institution-level candidate measures already exists. inferences about quality of care can be made by three sets of outcome measures using administrative claims data: 1. inpatient quality indicators (iqis)23 www .hpm.org/downloads/bellagicyarticlesicapitation _salary_ fee-for-service_ cochreview.pdf (last visited may 15, 2010). 20. david m. lawrence. a comparison of organized and traditional health care: implications for health promotion and prospective mmedicine. 44 methods inf. med. 273, 275 (2005). 21. christine k. cassel & troyen e. brennan, managing medical resources: retum to the commons? 291 jama 2518,2518 (2007). 22. fisher et al.,.supra note 12, at w5s. 23. the inpatient quality indicators (lqis) are a set of measures that provide a perspective on hospital quality of care using hospital administrative da2010] "shared accountability" approach 193 2. patient safety indicators (psis )24 3. medicare ambulatory care indicators for the elderly (macies)25 most performance measures currently in use are process measures. for example, the hospitalcompare program abstracts samples of hospital medical records to infer hospital quality.26 an example seen in the table below is "pci [percutaneous coronary intervention] received within 120 minutes of hospital arrival," the time to remove a blood clot this is use­ ful information but patients are more interested in their chance of survival. such an outcome measure is seen immediately below on the table as "30day mortality for acute myocardial infarction," which is an inpatient quality indicator. another source of measurements is patient survey data. self-reported health may be a good indicator of health care quality. consumer assess­ ment of health plans ( cahps) surveys27 measure this indicator but primar­ ily provide trenchant data on the patient-centeredness dimension of care. a third dimension of care, efficiency, remains devoid of any generally accepted measures. this may not be a problem to the extent that shared sav­ ings is the basis of performance awards. this is because many quality measures are based upon "avoidable hospitalizations," and it is the avoided ta. these indicators reflect quality of care inside hospitals and include inpatient mortality for certain procedures and medical conditions; utiliza­ tion of procedures for which there are questions of overuse, underuse, and misuse; and volume of procedures for which there is some evidence that a higher volume of procedures is associated with lower mortality. agency for healthcare research and quality, inpatient quality indicators overview, http://www.qualityindicators.ahrq.gov/iqi _ overview.htm (last visited july 30, 2008). 24. "the patient safety indicators (psis) are a tool to help health system leaders identify potential adverse events occlllting during hospitalization." agency for healthcare research and quality, patient sqfety indicators overview, htlp:llwww.qualityindicators.ahrq.gov /psi_ overview.htm qast visited july 30, 2008). 25. edward westrick & stephen koour, medicare payment advisory commission, medicare ambulatory care indicators for the elderly: refinement of the access to care for the elderly project indicators 2 (2006). 26. see hospital quality alliance, improving care through ltiformation overview: data collection, transmission & reporting, apr. 16, 2008, ,http://www.qualitynet.org/dcs/ contentserver?cid= 1121785350618&pagename=qnetpublic%2fpage%2fqnettier2& c=page (last visited july 30, 2008). 27. the consumer assessment of healthcare providers and systems (cahps) program is a multi-year initiative of the agency for healthcare research and quality (ahrq) to support the assessment of consumers' experiences with health care. the goals of the cahps program are two­ fold: develop standardized patient questionnaires that can be used to compare results across sponsors and over time; and generate tools and resources that sponsors can use to produce understandable and usable comparative information for both consumers and health care providers. agency for healthcare research and quality, the cahps program. http:// www.cahps.ahrq.gov/content/cahpsoverview/over _ program.asp?p= i 0 i &s= 12 (last vi­ sited july 30, 2008) 194 · ·indiana health law review [vol. 7:185 hospitalizations themselves that. generate the physician bonuses in a shared savings regime. an example is one of the· macies, "serious short term complications of diabetes mellitus." the more pressing imperative is to ensure that avoided hospitalizations result from the provision of appropriate ambulatory care and not from stinting or gaming. the following discussion references measures that could be examined if states were to be the level of accountability. it should be emphasized that these are cited for illustration only, as no group of measurements stands out as obvious criteria for rewards. it is also important to note that these meas­ ures have not in the past been applied to physicians-iqis and psis use hospitals as the unit of analysis; macies and carps are population-level measures. the aco, by charging both hospitals and their affiliated physi­ cians with responsibility for the health of the population they serve, applied fused accountability on all entities involved. :"• .'. 2010] "shared accountabh.jty, approach ·examples of metrics applicable to populations of medicare beneficiaries state/local national efficiency cost per medicare patient: number of doctor visits during last 6 months of life quality pci received within 120 minutes of $9,400 41.5 hospital arrival 128 min 30-day mortality for acute myocardial infarction 8.18% death among surgical inpatients with treatable serious complications (failure to rescue) 138 hospitalization for respiratory diagnosis in copd/ asthma 71 serious short term complications of diabetes mellitus 65 seniors reporting good, very good or excellent health 70.90/o patient-centeredness cahps overall rating of health care patients $7961 29 107min 6.05% 119 44 55 69.3% received 8.91 8.88 patients who always got appointmentas soon as they wanted 70.2 72.1 note: values are h othetical 195 it is important to note that aco goals must be se~ so tha~ performance is rewarded based upon all three dimensions. because cost can trade off against quality and access, crude measures of efficiency (e.g., cost alone) could encourage stinting in the other areas. precisely how doctors would be rewarded for improvements is beyond the scope of this paper, but it would . suffice to say that rewards should be structured so that doctors could share in any savings resulting from improved efficiency, so long as metrics for quality and patient-centeredness are no worse. further, doctors should, if possible given resource restraints, receive additional money if efficiency is no worse than the target but quality and patient-centeredness scores are im­ proved. suppose that: (a) the devolved sgr target pool provides a model for 196 indiana health law review [vol. 7:185 baseline efficiency;·(b) medicare's physician group practice (pgp) demon­ stration28 provides a model for awarding an accountable organization shared savings; and (c) the integrated healthcare association (rna) provides a model for awarding bonuses based uj>on quality and patient experience measures.· to take the example of an aco comprising all of new jersey physicians, a baseline pool of $10.8 billion would be established. imagine that after the first year of implementation, new jersey physicians have lo­ wered costs by five percent, or $540 million, while maintaining the pre­ vious year's performance on process measures such as time to reperfusion, outcome measures such as hospital mortality, and cahps scores relating to access and experience. as in the pgp demonstration, doctors would be awarded eighty percent of the shared savings. alternatively, suppose that medicare expenditures remained constant, but quality and patient expe­ rience measures improved. doctors could be awarded ·per-patient, per­ month bonuses according to a formula as in the rna program. over time, expectations for quality and patient-centeredness might be raised: if some units dramatically improved on those measures, states with similar demographics and resources might be expected to improve as well. similarly, expectations for efficiency might be raised. many commentators speak of about thirty percent of health care costs being wasted;29 achieving a goal of cutting this thirty percent would require that all acos operate with the efficiency of top-performing regions. the three dimensions cited by the 1om are not exhaustive. perfor­ mance goals could integrate public health. kindig argues that physician pay should include a '"pay-for-population health performance system' that would go beyond medical care to include financial incentives for the equal­ ly essential nonmedical care determinants of population health. ''30 kindig does not propose a unit of accountability for such a program, yet a state­ level aco would seem to fit naturally with this concept. an example of a public health indicator might be a decrease in standardized mortality rates. rosenthal and dudley suggest that a pay-for-performance scheme could include rewards for reducing disparities among underserved populations.31 evaluating performance within a system of local acos would not be as straightforward as doing so on the state level. the sparse level of sam28. 42 u.s.c. § 1395cc-1 (2009). 29. see, e.g., midwest business group on health, reducing the cost of poor quality health care through responsffile purchasing leadership i (2003); john e. wennberg, elliott s. fisher & jonathan s. skinner, geography and the debate over medi­ care reform, 2002 health affairs web exclusive w96, w97-w98. 30. david a. kindig, a pay-forppopulation health performance system. 296 jama 2611, 2611 (2006). see also michael mcginnis, institute of medicine, special remarks at the american enterprise institute for public policy research conference: determinants of avoidable mortality, investment in health promotion and disease prevention (july 23, 2008). 31. rosenthal & dudley, supra note 2, at 743. 2010] "shared accountability'' approach 197 piing required for statewide measurement would not be sufficient for small­ er populations, requiring wider use of instruments such as cahps surveys or the medicare health outcomes survey. iv. making the system work: tools at doctors' disposal a shared accountability regime assumes that doctors would apply col­ lective action to improve quality and efficiency. the sgr system was in­ tended to impose a global budget on physician services, by automatically cutting reimbursements when expenditures exceed the target amount. in the aggregate this mechanism should have created an incentive for doctors to reduce growth in expenditures, but in practice, with individual doctors act­ ing in their own interest, the system could not work. as med.p ac has observed, "the sgr system has several flaws.'.32 one, medpac notes, is the sgr's failure to address "inherent inflationary incentives" built into fee-for-service payment: medicare's fee schedule pays for the discrete services a physician fwnishes-visits, imaging studies, laboratory and other diagnostic tests, and procedures. such a small unit of payment gives physicians a financial incentive to increase the vo­ lume of services they finnish. most beneficiaries have supplemental coverage that shields them from the costs of services, which contributes to the problem. 33 studies have shown that physicians do in fact act·upon this incentive, and that ''reduced fees are likely to be met by a combination of an increase in volume and a shift in the mix or intensity of services fwnished to medi­ care beneficiaries'.34 as physicians seek to maintain a target income--the so called "income effect." the other flaw identified by medpac is the sgr's "lack ofdifferen-· tiation" among physicians. the sgr treats all physicians-regardless of their in­ dividual volume-inducing behavior-and regions of the country alike. across-the-board cuts fall particu32. medicare payment advisory commission, assessing alternatives, supra note 13, at 13. 33. /d. at 14. 34. memorandum from volume-and-intensity response team, office of the actuary, health care financing admin., to richards. foster, chief actuary (aug. 13, 1998) (on file with the indiana health law review), available at ht1p:/lwww.cms.hhs.gov/ actuarialstu­ diesldownloads/physicianresponse.pdf(last visited may 15, 2010) [hereinafter memo from volume-and-intensity response team]. 198 indiana health law review lady hard on specialties that have less opportunity to inflate the volume and intensity of the services they · · provide and on regions of the country that have dem­ onstrated more efficient practice patterns ... at the same time, the sgr treats all volume increases the same, even though some may be desirable, such as those that improve quality or that substitute for more expensive nonphysician services.35 [vol. 7:185 "ideally, an expenditure target would provide individual physicians with an incentive to control the volume of services,'.j6 medp ac notes. "but under the sgr, an efficient physician who reduces volume does not realize a proportional increase in payments. in fact, that physician loses twice­ once by reducing billed services and once through reduced future fees."37 under a shared accountability system, ideally these incentives should be reversed. the overarching incentive created by the aco regime is for doctors to cooperate among themselves and with other providers to generate a positive update. the localized aco gives doctors a realistic opportunity to cooperate in quality and efficiency efforts because of the small number of physicians and other providers in the pool.38 cooperative efforts must be organized. legislation establishing the aco regime could provide for creation of a convening entity for each aco, or leave it to the hospitals and physicians involved to decide on their own whether or how to coordinate their activities. for the latter approach, congress could simply devolve the sgr structure to a lower level, and couple it with incentive pools. in the pop demonstration, it was not neces­ sary for legislation to establish governing structures for the accountable or­ ganizations-it simply set the ground rules for payment. in one case, a group of doctors constituted themselves on their own initiative (the middle­ sex health system) and went to work. 39 in other cases, existing group prac­ tices joined the project; but in all cases, each doctor group organized its own care coordination processes. to the extent that the payment structure applies parallel efficiency and quality standards, and rewards, to both the hospital and the extended medical staff, these sometimes antagonistic par­ ties should be able to act in concert. any legislation. requiring or permitting a cos would need to provide 35. medicare payment advisory commission, assessing alternatives, supra note 13, at 14. 36. /d. 37. /d. 38~ see mancur olson, the logic of collective action: pubuc goods and the theory of groups 33-36 (harvard university press 1971). 39. michael trisolini et al., medicare physician group practices: innovations in quality and ej!iciency, 41 the commonweal til fund report viii (2006). 2010] "shared accountabll..ity" approach 199 for exemptions from regulations for cooperative activity consistent with the purpose of a shared accountability regime. arguably, the sharing of savings could violate the anti-kickback statute40 or the civil monetary penalty sta­ tute;41 and sharing of resources such as-electronic medical records between a hospital and physicians could violate the physician self-referral law (known as the "stark law"). 42 it should be noted, however, that the hhs inspector general has approved such arrangements when they are made in the spirit of improving the quality and efficiency of care.43 the tools available to doctors would fall roughly into two categories, regulatory and clinical, although the self-regulatory nature of much of the health care system tends to blur·the lines between the two. by regulatory approaches, we mean that doctors could influence poli~ cymaking that would tend to improve quality and efficiency. . essentially these involve doctors lobbying state policymakers to institute reforms, three such approaches come to mind: • limiting system capacity. because heath care costs rise with in~. creased capacity, the quickest and easiest way to lower-costs is to lower capacity when resources exceed the level necessary to safely provide medical care.44 possible reference points for the appropri ... ate resource level would include those of the dartmouth-identified "benchmark" regions and of an integrated delivery system, such as kaiser permanente.45 two regulatory strategies · suggest them­ selves: (1) urging state health planning agencies to restrict, or limit growth of, facilities within their jurisdiction; . or, in states without certificate-of-need laws, urging legislatures to enact thj;lm .. (2) urging state officials to limit capacity in state-owned or funded facilities; for example, to reduce bed capacity in public hospitals, or to cut back non-essential residency programs at state university medical centers. • stricter quality enforcement. where there is no collective accoun­ tability for quality, a "code of silence" as to poor performers can ·r.' 40. 42 u.s.c. § 1320a-7b. 41. 42 u.s.c. § 1320a-7a. 42. 42 u.s.c. § 1395nn. 43. see, e.g., w. clifford mull, office of inspector general gives gainsharing ar­ rangements a yellow light, http://www.walterhav.com/library/news_articles/ gainshar­ in!flo20article.pdf (last visited nov. 16, 2009); nixon peabody health law alert, federal government clearing the way fore-prescribing and electronic medical records, nov. 1, 2005, http://www.nixonpeadbody.com/publicationslbla_ll-12-5.pdt: 44. elliott s. fisher et al., associations among hospital capacity, utilization, and mortality of us medicare beneficiaries, controlling for sociodemographic factors 34 health serv. res. 1351, 1351-62 {2000). 45. david goodman, et al., benchmarking the us physicifm wor/iforce: an alterna­ tive to needs-based or demand-based planning, 276 jama 1811, 1811-17 (1996). 200 indiana health law review [vol. 7:185 thrive.46 but when every provider's compensation is dependent upon achievement of quality outcome goals, the incentive is to re­ move poor performers from the accountable unit. among the strategies available are: (1) more rigid enforcement of hospital standards by state surveying agencies; (2) stricter discipline im­ posed upon doctors by state medical boards and quality improve­ ment organizations; (3) tougher maintenance of certification requirements for practicing doctors, or higher thresholds for initial licensure. in some cases this would be easy, as where a doctoral­ ready has a reputation for impairment or incompetence, and can be removed from the pool by revoking his hospital admitting privileg­ es and/or instituting license revocation proceedings. • public health approaches. to the extent that performance goals in­ clude general health measures, and the health status of a geograph­ ically compact and cohesive population is being measured, doctors can add public health strategies to their lobbying priorities. for in­ stance, doctors could lobby local governments to increase access to grocery stores and decrease access to fast food outlets; to raise al­ cohol and tobacco taxes; and to plan walkable communities in which seniors are likely to remain active. there are several clinical approaches by which doctors could act col­ lectively to improve quality and efficiency. • organized forbearance in volume and intensity of care. the cor­ nerstone of the collective efficiency effort is cooperation in hold­ ing down utilization beyond the point where marginal expenditures yield no further benefit. some outlier doctors may be known to perform procedures at an eyebrow-raising volume,47 and their im­ mediate removal from the pool could be a very quick avenue to a noticeable increase in the group's conversion factor. in the ac­ countable care organization, there need be no insurer or utilization review process looking over doctors' shoulders-the doctors them­ selves must draw the line between necessary and unnecessary care. they must also enforce compliance, because if any doctors "de­ fect" from the agreement and bill for more services than are neces­ sary, they reduce the conversion factor for the unit as a whole and force the rest of the doctors to follow suit-the same dynamic pre46. see generally rosemary gibson and janardan singh, wall of silence: the untold story of tile medical mistakes that kill and injure millions of americans (life line press 2003). 47. see, e.g., deborah gates, lawsuit filed in stent surgeries: 24 plaintiffs seek more than $30k per count, the daily times (salisbury), jul. 22, 2008, at i (providing a real-life example in relation to stent surgeries). 2010] "shared accountability" approach 201 vailing in the current, nationwide sgr regime. to maintain com­ pliance, doctors in the aco will probably want to use some of the same techniques that insurers use to identity outlier doctors. use of such techniques in the aco, however, will be different in that doctors themselves must be satisfied as to the validity of methods (e.g. physician profiling software )48 and the fairness of any process used to identity outlier colleagues. • clinical integration. the cornerstone of an aco's collective quality effort would be clinical integration, argues thomas run­ dall. this would involve "providers working together in an inter­ dependent fashion so that they can pool infrastructure and resources; and develop, implement [and] monitor protocols, 'best practices,' and various other organized processes.'.49 examples cited by rundall include coordination across entities for an entire episode of care, creation of disease registries. and other chronic care programs, facilitation of electronic health record (ehr) ac­ quisition, and even supply chain management. fisher and col­ leagues note that one of the advantages of larger organizations relates to their capacity to invest in improving quality and lowering costs. most physi­ cians remain in solo or small group practices and have neither the capital nor organizational capacity to in­ vest in health information systems, the implementa­ tion of care management protocols, or ongoing quality improvement initiatives. hospitals or large medical groups are much better positioned to invest in such systems and to provide financial and technical support to physicians aligned with their institution. 5° • infrastructure development. rundall also argues that the well­ organized aco would "develop mechanisms to monitor and con­ trol utilization of services and enhance quality and efficiency"51 in­ cluding feedback on performance, peer-to-peer counseling, and tools and processes to help physicians improve quality. the neces­ sary infrastructure to accomplish this, says rundall, is a paid pro­ fessional staff led by a medical director that could collect and 48. see lewis sandy, the future of physician profiling. 22 j. of ambulatory care mgmt. 11, 11 (1999). 49. thomas rundall, university of california, berkeley, accountable.care organiza­ tions: key characteristics and activities, presentation at academy health annual research meeting (jun. 4, 2007). 50. fisher ,et al., creating accountable care organizations, supra note 12, at w53. 51. rundall, supra note 49. 202 indiana health law review [vol. 7:185 analyze data, as well as shared nurse care managers to coordinate the education and care of patients. • exclusivity. ultimately, the ability of the aco to enforce im­ provements relies upon the power to exclude physicians who do not act in the spirit of the cooperative venture. speaking of an an­ tecedent of the aco, the independent practice association, james robinson has written, credentialing on clinical, cultural, and economic grounds seeks to ensure that the physicians participat­ ing in the health plan or medical group embrace the organizational goals of appropriate care, and hence avoid both overand undertreatment, independent of explicit payment incentives. the creation of physi­ cian networks with limited participation creates a supplementary nonprice mechanism through the po­ tential threat of termination. preemployment screen­ ing and the threat of termination are core principles of every employment situation and are applied in a loos­ er fashion to networks of quasi-independent practi­ tioners.52 presumably any aco must have the power to expel a doctor, al­ though the means of doing so and the consequences for the doc­ tor-and patients-must be carefully considered. due process for the physician is a must. if a hospital is the locus of an aco, and admitting privileges are revoked, would this constitute expulsion from the aco? could a doctor be expelled from the aco pool without having credentials revoked? how would medicare pay­ ment be affected if a doctor does not belong to aco? if the doctor were simply kicked into a residual pool, rather than barred from participating in medicare, the doctor presumably would be paid less, losing opportunities for shared savings or other positive up­ dates to the conversion factor. but that doctor's patients would lose the benefits of clinical integration that the aco structure is meant to confer on patients. determining the consequences of aco ex­ pulsion will require a careful balancing of the doctor's right to con­ tinue practicing, the patient's right to remain loyal to the maverick doctor, and the need to keep patients within a care coordination re­ gime. 52. james c. robinson, theory and practice in the design of physician payment in­ centives, 79milbankq. 149, 165 (2001). 2010] "shared account ability" approach 203 it could be stressful for doctors to crack down on colleagues who are in the bottom tier of efficiency and quality. but if certain doctors would be a drag on the pool's financial performance, the aco's physicians will have to make a choice: subsidize the poor performers' continued practice by ac­ cepting a lower conversion factor for their fees, and explain to the commu­ nity why the aco's quality ratings remain sub-par; or expel the doctors, a move that would be in the aco's financial interest and the public's interest as well. a middle-ground strategy would be to identify poor performers and allow them a chance to remediate. this would be less gut-wrenching than simply expelling poor performers, but would require the majority of doctors to suffer financially for a time in the name of group solidarity. efficiency and quality rankings would not be the only potential clea­ vage among doctors in an aco. those doctors who profit from ancillary services or ownership of surgical facilities could also be seen as taking more than their fair share of the aco's sgr pool.53 doctors would have to carefully scrutinize these physician-owned facilities to determine whether they add to or subtract from the aco's overall quality and efficiency scores. doctors would also have to scrutinize the utilization patterns of their investor-physician colleagues. in any event, doctors would enjoy a major advantage under the aco regime relative to other cost-containment regimes: doctors would be empo­ wered to choose the cost containment strategies themselves. rather than an insurance carrier or bureauctacy scrutinizing their activities, doctors could police themselves. they would have to reach consensus on the validity of any physician profiling methods, recertification programs, utilization re­ view processes or other techniques-none would be imposed on them by outsiders. au that would be imposed on them are performance goals based on the experience of their peers in high-performing regions; it would then be up to each local medical community to determine how they can achieve the benchmark performance level. v. four models of shared accountability this part of the paper posits four types of shared accountability re­ gimes. it is not the purpose of this paper to propose or advocate models, only to assemble features of existing law, existing pay-for-performance demonstration projects, and ideas floated by commentators into somewhat more concrete descriptions of possible models, and then speculate how such models might operate in practice. the discussion assumes the following: 53. see, e.g., medicare: physicians who invest in imaging center refer more patients for more costly services: hearing before the subcomm. on health of the h. comm. on the ways and means, 103rd cong. 1-8 (1993) (statement of janet l. shinkles, director, health financing & policy issues, human resources division). 204 indiana health law review [vol. 7:185 that some type of sgr mechanism would set targets for global expendi­ tures; that the current methods of calculating fees would remain in effect; that the accountable unit would share in savings through mechanisms simi­ lar to those employed in the physician group practice demonstration; and that additional funds could be added to the accountable unit's pool for dis­ tribution to reward achievement, based upon currently existing outcome or population health. measures. it should be noted at this point that medicare's sgr does not represent the only possible model for a global budget under which an aco could function. for instance, president bill clinton's 1993 health care reform package proposed all-payer global budgets at the state or local lev­ el, 54 and a similar model prevails in germany. 55 in the event that the united states adopted such cost containment techniques, the aco model would provide a superior method of delivering care to the non-integrated bodies of physicians receiving fees under the 1993 clinton or current german model. a. state level the simplest model of shared accountability would be to devolve the sgr pool to the state level. in this iteration, the conversion rate for physi­ cian fees would be calculated as they are under current law, but at the state level. in states where expenditures come in below the target (assuming steady or improved performance on quality and patient-centeredness meas­ ures) physicians would receive a positive update. 56 in states were expendi­ tures exceed the target, physicians would receive a negative update unless improved performance on the quality and patient-centeredness dimensions cancelled it out. as frank opelka has noted, a regional spending target will face technical and po­ litical obstacles. regional proposals. . . will run into the obstacle that most physicians are currently inde­ pendent. regional spending target programs will have major challenges in bringing clinical disciplines to­ gether except in existing integrated systems. each re­ gion will need to compare its current performance against benchmarks and seek opportunities for im­ provement ... toolkits for regional entities to imple54. health security act, h.r. 3600, 103d cong. (1st sess. 1993). 55. richard knox, keeping german doctors on a budget lowers costs, npr, jul. 2, 2008 http://www.npr.org/templates/story/story.php?storyld=91931036. 56. see medicare payment advisory commission, report to tiie congress: medicare payment policy 172 (march 2005) [hereinafter medicare payment advisory commission, medicare payment policy]. 2010) "shared accountability" approach ment the program will facilitate the implementation and likelihood of overall success.57 the following vignettes imagine scenarios that could ensue under this model: 205 • east dakota is one of the states identified by dartmouth researchers as already providing high quality care at relatively low costs. analysis of medicare claims data reveals that east dakota already meets quality benchmarks, and growth in costs is within the limits prescribed by the 1997 sgr formula. it is immediately apparent to the medicai society board members that, had east dakota been in its own sgr pool heretofore, its doctors would have received posi­ tive updates rather than negative updates. the board decides that, since the state's health care system is working well, no organized response to the aco legislation is necessary; doctors will continue to practice as they have previously and will continue with ongoing quality improvement efforts. • new guernsey is a state with relatively high quality rankings but with high costs as well. in new guernsey, the average medicare beneficiary pays about $900 in part b coinsurance, well above the national average of about $700. an affiuent state with many plea­ sant, leafy suburbs, new guernsey has attracted a large contingent of medical specialists. while proud of its talented physician work­ force, the state medical society's analysis of medicare data reveals that the high intensity of specialty care given to chronically ill med­ icare beneficiaries cannot be linked to better outcomes. moreover, new guernsey's rate of certain invasive medical procedures is far higher than the national average. the medical society asks the state legislature to order a hiring freeze for over-represented medi­ cal specialties at the state's academic medical centers pending a study to determine the optimal specialty distribution of the state's physician workforce. the medical society also commissions the state's qio to conduct a case/control study of patients with condi­ tions that receive disproportionate rates of surgery in new guern­ sey relative to other states, and separate, specific probes of hospitals and surgeons that perform unusually high volumes of such proce­ dures. it expects that unnecessary utilization will be eliminated, and the remaining physicians will share larger slices of the medi­ care pie. 57. frank opelka, the sustainable growth rate: bringing the sgr to individual providers, healrn affairs bu>g, feb. 20, 2008, http:/lhealthaffairs.orglblog/2008/02/20/ the-sustainable-growth-rate-bringing-the-sgr-to-individual-providers/. 206 indiana healm law review [vol. 7:185 • west carolina is a state with poor quality ratings and, while not ranked near the top in spending, seems to be spending more than it should given its outcomes. observers note that the state board of medicine has consistently .low rankings in disciplinary actions per 1,000 doctors, and a large number ofhospital beds per capita seems to be driving a high number of hospital days during chronically ill medicare beneficiaries' last two years of life, many of them in icus. the medical society mounts a comprehensive quality im­ provement campaign. one element, inspired by jack welch's strat­ egy of forcing out the lowest performing managers, urges doctors to provide confidential evaluations of peers and hospitals to regulatory authorities. the board of medicine is given an infusion of re­ sources to pursue disciplinary proceedings. the state health plan­ ning agency is urged to convene a hospital closing commission to reduce bed capacity at the least effective facilities. with both state residents' self-reported health status and public health expenditures ranking low, the medical society persuades state legislators that the most cost-effective way of improving health outcomes is not through more health care delivery spending but through more pub­ lic health and prevention efforts. the medical society expects that its commitment to a new paradigm will improve the medicare pop­ ulation's health, recruit new, talented doctors to the state, and, not incidentally, bring p4p bonuses to its members. b. local level: extended hospital medial staff /multi-specialty group practice the most administratively complex shared accountability model would be one with multiple acos formed at the local level. in the hypo­ thetical scheme discussed below, physicians would initially be assigned to a pool based upon the "extended hospital medial stafl" (ehms}--empirically observed referral patterns derived from the methodology described by fish­ er and colleagues. doctors would then be free to opt out of their assigned pool and affiliate with another pool, should it accept the doctor; or to carve out an entirely new pool based on the multi-specialty group practice model. the latter could be an existing multi-specialty group entity, or a newly created independent practice association. each aco would also be assigned, for administrative purposes, its doctors' patients. those patients would form the population on which the aco's expenditure pool would be risk-adjusted and on which performance outcomes for the aco are measured. it would not, however, constitute a network to which patients are bound, since medicare beneficiaries are free to see any doctor. this means that doctors would need to persuade assigned patients to accept their referrals, and follow the patients' progress. once a physician must cast his lot-:--and future updates-with a pool, 2010] "shared accountability" approach 207 he may decide to rethink his affiliation. a doctor may suspect that the qual­ ity of hospital a is poor, or that the doctors who admit there treat patients too aggressively, and decide to switch his affiliation to hospital b. allow­ ing doctors to ''vote with their feet," provided that they do in fact restrict their referrals to the provider community associated with hospital b, could be beneficial to patients and to medicare. doctors would refer patients to providers they believe to be effective and efficient. doctors unable to switch to a better hospital, because they do not have admitting privileges, would have an incentive to improve the quality and efficiency of the hospit­ al and pool in which they remain, by, for instance, becoming active in hos­ pital committees. doctors who felt that they could not improve their default pool's per­ formance might opt to form or join a multi-specialty group practice whose patients would comprise a separate pool. many in the health policy com­ munity believe that such an arrangement would benefit patients. but pa­ tients could not be restricted to receiving their care from doctors in the group, given the distinction between ffs medicare and part c plans, so the pool would be an odd neither-fish-nor-foul creature. as medp ac noted, cms ... would have to devise a way of attributing services received by individual beneficiaries to groups without locking beneficiaries into receiving care from any specific group. some health plans have developed algorithms that attribute patient care to particular groups on the basis of the percentage of care they re­ ceive from any one group. medicare might adopt such a methodology for its own use, but the process would likely be complex and raise many questions.58 nonetheless, if such an option would encourage competition and integration of delivery systems while still letting doctors maintain the autonomy they enjoy in the ffs system, the option might be worth the trouble. the following vignettes illustrate how providers could react to a sys­ tem of local a cos: • dr. smith has admitting privileges at both northside hospital and southside hospital. because the majority of his medicare patients have been treated at northside hospital, he is given a default aco assignment to that institution's ehms. upon reflection, dr. smith realizes that he has referred patients to northside primarily for rea­ sons of convenience, not because he is convinced that its clinical 58. medicare payment advisory committee, medicare payment policy, supra note 53, at 172. 208 indiana health law review [vol. 7:185 . quality is superior to southside. he switches his assignment to southside based on his belief that performance bonuses earned by the southside ehms will more than offset his travel costs. • same scenario as above. a number of stakeholders in central city have expressed concern about the cost and quality of care at north­ side hospital, which has also had a poor relationship with doctors in recent years. board members of the hospital are concerned that the advent of acos could cause doctors to take their medicare pa­ tients away from northside en masse. the northside board asks the hospital ceo to resign and appoints a management committee that includes doctors to iron out problems and develop a physi­ cian/hospital organization (pho) structure through which doctors and hospital administrators can collaborate to improve quality and efficiency. • same scenario as above. because risk adjustment criteria increase the pool of money for a cos with diabetic patients, and shared sav­ ings from avoided hospitalizations leave more money in the pot for doctors, the northside pho decides that the large number of diabet­ ic medicare beneficiaries living at the north end of central city could make diabetes care a profitable area of concentration. the pho assesses doctors a small amount of money to fund a pho­ wide diabetes registry and care coordination team. the pho then advertises its expertise and resources in the senior community to persuade diabetic patients to choose northside-affiliated doctors. as employers and private insurers in central city see improved outcomes, they agree to make additional payments to the northside pho to enroll their insureds into the chronic care program. • same scenario as in the first two bullet points, except that the lea­ dership of northside hospital is unable to convince enough doctors to remain in its ehms for the hospital to remain viable. central city's mayor and civic leaders broker an agreement by which northside and southside hospitals merge. only southside will pro­ vide inpatient care, as it has clearly proven its superiority in inpa­ tient quality. northside will remain open only to provide outpatient care and emergency care. the move is applauded by insurers and the business community, who long felt that that central city had excessive hospital bed capacity and that operations should have been consolidated at southside. • dr. jones is medical director of medical faculty associates, a mul­ ti-specialty group practice that is considered central city's finest. because medical faculty associates is based at central city uni­ versity hospital, all members of her practice have been assigned to an ehms pool that includes many other doctors who send patients to that hospital. convinced that her medical group can outperform other doctors in the ehms, dr. jones persuades her colleagues to 2010] "shared accountability" approach 209 file papers with cms carving out their group practice as a separate aco with a separate pool. • dr. wilson is a member of a pho described above. the pho doc­ tors adopt guidelines for the frequency of office visits for controlled hypertension, and creates a patient registry for diabetic patients. it is agreed that each doctor will waive beneficiaries' coinsurance for certain recommended treatments for diabetics as part of a campaign to eliminate preventable complications. strapped for cash, dr. wil­ son decides to disregard the guidelines on hypertension to generate extra office visits, and to collect coinsurance on all services to di­ abetics. staff hired to administer the pho discover dr. wilson's conduct and he is confronted by a delegation of peers. dr. wilson complains that the new medicare system is unfair and impairs his ability to earn a fair income. the pho votes to expel dr. wilson. • eventually, central city is served by four acos. each aco "brands" itself and advertises its network to medicare beneficiaries as consisting of high-quality providers. central city's medicare population is, in essence, served by a variant of the "managed com­ petition" model envisioned by alain enthoven. • puritan hospital, situated in a rural state without certificate-of-need laws, has faced financial pressures from physician-owned cardiac and orthopedic hospitals taking away profitable procedures that have cross-subsidized less remunerative facilities such as burn care and emergency care. additionally, doctors affiliated with the spe­ cialty hospitals have been able to avoid emergency room coverage. under the algorithm for ehms assignments, the doctors practicing at the specialty hospitals are assigned to an aco based at puritan hospital. because of the pool structure, the specialty hospital doc­ tors now have a financial stake in the quality and efficiency of care delivered to the county's entire medicare population, not just their own patients: bonuses to the pool as a whole depend on reducing readmissions and 30-day mortality at all three hospitals. the coun­ ty medical society mediates an agreement between puritan hospital and the specialty hospital doctors to ensure that cardiac and ortho­ pedic procedures are performed at the facility where efficiency and quality is maximized and that the specialists resume their emergen­ cy on-call duties at puritan. the medical society also initiates talks with walk-in clinics at local retail stores, which have also been as­ signed to the aco, to ensure proper coordination of medicare pa­ tients' care. one can also imagine the virtual integrated delivery systems formed for medicare beneficiaries serving as platforms for activities entirely unre­ lated to medicare. private insurers could piggyback pay-for-performance programs on an aco structure. {indeed, the reverse could happen too210 indiana health law review [vol. 7:185 doctors included in a private insurer's high-quality, high-efficiency network could perceive,an advantage to using the insurer's designation to sort them­ selves. into an aco). a cos could also become purchasing cooperatives for obtaining malpractice insurance, perhaps at significantly lower rates if insurers perceived their clinical integration as lowering risks. the prospect that an enthoven-model competition among a cos could eventually emerge recalls the threshold question, "accountable to whom?" while· ultimately the purpose is to make providers accountable to patients, in its initial formulation, the accountability flows to cms. but if something approaching managed competition is possible in an aco regime, it might be possible at some point for performance rewards to be dropped and re­ placed entirely by consumer choice. after some time, all acos would have performance records that consumers could easily compare. in an ideal scenario, the best systems would attract greater numbers of patients and would earn increased profits from higher volume, obviating the need to re­ ward performance with higher per-unit pay. it should be noted, however, that many experts are skeptical· that consumers do, or are ever likely to, scrutinize performance reports to this degree. c. insurer-convened aco an accountable care organization convened by a "medigap" (medi­ care supplement · insurance) insurer would bear some superficial resem­ blance to "medicare select" networks formed to serve medigap policyholders. 59 · like medicare select, such an aco would likely be built around a contracting hospital and would enroll beneficiaries into a network­ oriented medigap policy. unlike medicare select, however, the primarjr purpose would be to save money through improved quality and efficiency, not through negotiated discounts. a medigap-centered aco could be authorized by allowing a medigap insurer to enroll some of its beneficiaries into a preferred provider network within medicare and share in savings (with cms and providers) that it can attribute to better-than-expected performance by its network. the insurer could then identify providers that, judging from its own experiences in the private market, could be expected to deliver high-quality, efficient care; or supply a common it platform physicians that would assist them in this task. , . • midwestern standard insurance has found that of three competing hospitals in middletown, community general hospital seems to deliver the best care to its enrollees at .the lowest costs. it applies ahrq's inpatient quality indicators to medicare claims data from the three hospitals and finds that community general also seems to 59. 42 u.s.c. §1395ss(t) (2003). 2010] "shared accountability" approach 211 provide the best care to medicare patients. utilizing the methods developed by dartmouth researchers it examines medicare claims data to identify the de facto "extended medical staff' of physicians who refer to each of the three hospitals and then applies macies to those doctors' patients' claims, and learns that this virtual group of physicians also provides superior ambulatory care to its patients. the insurer approaches the hospital leadership with a proposal that they jointly market a medigap product through the existing physi­ cian "network." doctors sign on to the arrangement in exchange for the insurer's promise to pay them, from the insurer's shared savings pool, end-of-year bonuses based on the number of medicare pa­ tients in their practice. • same scenario as above, except that doctors are oowilling to sign onto any arrangement. but rather than abandon the project, mid,.. western standard enters into a contract with community general only. the resulting medigap product is marketed to beneficiaries based on the hospital's quality record of superior outcomes and a lower premium based on the ehms physicians' efficiency. how­ ever, midwestern standard still promises, unilaterally, to pay doc­ tors who are part of the de facto extended medical staff end-of-year bonuses so long as they continue to maintain the same level of qual­ ity and efficiency. after receiving the first year's bonuses, as well as many new patient referrals from the insurer, the physician com­ munity decides to formalize the arrangement. • same scenario as above. st. aloysius hospital, another hospital in middletown, and its affiliated physicians, have noticed a drop in medicare patient load since community general began offering its medigap product. st. aloysius officials approach prairie standard insurance about forming an aco to offer a competing product. af­ ter performing the same research on middletown health care that midwestern standard did, prairie standard officials conclude that adoption of electronic medical records and a concerted effort by st. aloysius and its doctors to lower the intensity of care would likely enable the aco to earn shared savings bonuses within two years. the hospital and nearly all its de facto ehms doctors agree to form a pho and contribute capital to purchase an emr system. some would argue that a medigap-convened aco would amount to the "tail wagging the dog." allowing such an option would, however, af­ ford an additional opportunity for innovation in serving the medicare popu­ lation. d. a "competitive dynamic" approach to updates a fourth possible model for shared accountability is suggested by 212 indiana health law review [vol. 7:185 comments made by medpac commissioner francis crosson during that panel's discussion of the accountable care organization concept. after not­ ing the unpopularity of the sgr, crosson observed: ... the target or the use of targets is in the end going to · be less important than the dynamic that is created by the payment system because the target really just ad­ dresses the amount that's paid ... *** so i have less interest or concern about the target as a starting point and what that ought to be than the na­ ture of the dynamic. i think i'll just give an example ·· of· what i think might be something that illustrates that ... *** [s]tarting with some basis for next year's payment that would be either based on reasonable input costs or perhaps, in some circumstances, less than that based upon what we think we can afford as a country, taking that number and perhaps modestly adjusting it regionally. let's say we ended up with a number of2 percent as a starting point, and we could arrive at that number by a number of different means. *** but then... [physicians in geographic regions], group practices [or] accountable organizations which would include physicians and medical staff physicians in hospitals -would essentially work sort of in competi­ tion with each other around that number. and there · would be a range around that number of reward or · loss based on that ... you might end up with a 3 per­ cent range on each side. and so you could have with­ in each geography some entities that ended up with a couple of points minus [two] and some that ended up with 4 or 5 ... *** [a] system of slow inexorable competition with 2, 3, 2010] "shared accountabh..ity" approach 4, 5 percent differentials year-to-year [that] would, in fact, create the dynamics that we're interested in.60 213 in crosson's view, "there is a current opportunity to investigate whether a subset of the national physician community, properly equipped and with proper incentives, could manage both the volume of services and the quality of services delivered to medicare beneficiaries over time, within a fee-for-service setting." 61 this discussion uses crosson's concepts as a jumping-off point for envisioning informal or voluntary means by which doctors could compete, at the level of a geographic or other unit, for a li­ mited pool of increased medicare funding that would be apportioned based upon performance. medp ac chairman glenn hackbarth recently noted that the sgr may be more useful as a ''tool for altering the dynamic of the policy process than as a tool for directly improving how providers deliver services. an expenditure target alerts policymakers that spending is rising more rapidly than anticipated and leads to an annual debate over the update to the physi­ cian payment rate. that debate may also influence the behavior of provid­ ers: to avoid rate decreases, they could be compelled to support payment reforms that they might otherwise find objectionable.'.62 in fact, the sgr has led to annual debates about updates, but the de­ bates have not as yet led to payment reforms. perhaps, as part of these de­ bates, a "competition" of the type envisioned by crosson could be kicked off either formally, through laws passed or position statements made by government officials, or informally, by position statements made by stake­ holders. one can picture several means by which some measure of competition could be formally initiated by government officials: • the first such proposal along these lines emerged in the champ act, a bill passed by the house of representatives in mid-2007.63 section 304 of the bill would have provided a five-percent bonus 60. transcript of public meeting at 25-28, 69, medicare payment advisory commis­ sion (jan. 9, 2007), available at http://www.medpac.gov/transcripts/all_medpac.final.pdf (last visited may 15, 2010). 61. jay crosson, an sgr reform proposal: the impact of a payment update alter­ native for multi-specialty group practices, health affairs blog, feb. 19, 2008, http://healthaffairs.org/blo~2008/02/19/an-sgr-refonn-proposal-the-impact-of-a-paymentupdate-altemative-for-multi-specialty-group-practices/. · 62. assessing alternatives to the sustainable growth rate system: hearing before the subcomm. on health of the h. comm. on energy and commerce, 110th cong. 2 (2007) (statement of glenn m. hackbarth, chairman, medicare payment advisory commission), available at http://energycommerce.house.govlimageslstories!documents/hearings/pdf/ 110-he-hrg.030607.hackbarth-testimony.pdf (last visited may 15, 2010). 63. children's health and medicare protection act of 2007, h.r. 3162, 11 oth cong. (1st sess. 2007). 214 indiana heal til law review [vol. 7:185 to physicians in counties or equivalent areas in the united states in the lowest fifth percentile of utilization based on per capita spend­ ing. this proposal tracks closely with the one crosson informally proposed during the medp ac discussion in that it awards a higher update to physicians in higher-performing regions. this proposal, while intriguing, was deficient in that it did not require mainten­ ance of quality or patient experience metrics. • · a policy option identified by the commonwealth fund commis­ sion on a high performance health system would eliminate pay­ ment updates to providers in regions with per-beneficiary spending exceeding the 75th percentile (defining regions as metropolitan areas or combined rural areas in each state); update payments on a sliding scale for regions between the 50th and 75th percentiles; and award full updates only in regions with spending at or below the 50th percentile. the commission estimated savings to medicare of $157.8 billion over ten years.64 , congressional budget resolutions could state,. in advance, the amount of money to be allocated for a physician pay increase, and · urge that the updates be distributed on the basis of merit rather than across the board, thereby challenging physicians to improve per­ formance. • leaders of congressional committees with jurisdiction over medi­ care, or officials of hhs, could announce that they will support only a limited increase and set forth criteria by which the addition­ al dollars should be distributed. one can also imagine a process initiated by stakeholders: • organizations representing medicare beneficiaries, perhaps allied with business groups or insurers, could propose criteria for award­ ing pay increases, and pledge to lobby for updates limited to quali­ fying units. • physician organizations in states with high quality, efficient health care could break away from national physician groups to negotiate a "separate peace" in which they receive generous updates but oth­ ers do not. indeed, such a dynamic was reportedly at work in the lobbying by doctors from minnesota and wisconsin for inclusion of section 304 in the champ act.65 • cms could formally invite groups of physicians to carve them­ selves out of the nationwide sgr pool into smaller pools on a pilot64. cathy schoen,· et al., bending the curve: options for achieving savings and im­ proving value in u.s. health spending, 80 the commonwealth fund 1, 59 (2007). 65, ·champ would provide 5 percent ffs bonus for efficient providers, inside cms, aug. 9, 2007, 2007 wlnr 15338105 .. 2010] ••shared accountabilfly" approach 215 program basis. crosson has proposed such a mechanism, in which physicians in multi-specialty group practices who care for medicare beneficiaries on a fee-for-service basis could apply for inclusion in a separate pool upon "demonstrated ability to use evidence-based medicine and other systematic processes of care; electronic medical information capabilities; the use of systematic quality of.care im­ provement techniques; responsible physician compensation practic­ es; and the willingness to be part of a collective, transparent mom­ monitoring and improvement process.'.66 as noted earlier, there are a number of population-level measures that can be used to evaluate the efficiency and quality of health care. officials or stakeholders could construct grids plotting each state's efficiency measures on one axis and quality measures on another axis. the resulting matrix, if plotting increased efficiency from left to right on the x axis, and increased · quality from top to bottom on the y axis, would identify candidates for me­ rit increases in the upper right quadrant. thus, to apply crosson's example assuming a base level of a positive two-point update, a first iteration of a competitive dynamic process could make states in the upper right quadrant eligible for three point updates, and states in the lower left quadrant rele­ gated to one-point updates. in a second iteration, doctors who believed that they could outperform same-state peers might feel challenged to form some type of cohesive group that would cooperate to improve performance and set itself apart from the larger group to earn a more favorable update. the following illustrations draw upon examples described earlier in this paper. imagine that the state of new guernsey falls in the middle and has been identified by policymakers or stakeholders as deserving of a two percentage point update . . • representatives of the new guernsey state medical society organ­ ize a meeting with their state's congressional delegation. the doc­ tors are upset because their quality ratings place them in the upper tier on that dimension yet they are being denied a three-point up­ date due to inefficiency. they inform their represtrr~tatives that if they do not receive the three-point update, doctors may have to stop seeing medicare_ patients. senator burton responds by. noting that in states receiving three point updates, medicare beneficiaries pay substantially less in coinsurance, and that if new guernsey doctors received the three-point update, his constituents would pay the highest average coinsurance among the 50 states. the congression66. crosson, supra note 58. see also laura a. dummit, updating medicare's physi­ cian fees: the sustainable growth rate methodology, 818 nat'l health pol'y f.1 (2006); mark mcclellan, medicare payment for high-quality, efficient care, presenta­ tion at fifteenth princeton conference on health care economics and policy (may 28, 2008). 216 indiana health law revffiw [vol 7:185 al delegation tells the doctors to develop a plan for increased effi­ ciency, and pledges that if the doctors can show progress in ing costs while maintaining quality outcomes, they will fight for a full three-point update the following year. • dr. brown, the solo practitioner in central city who has been con­ sistently named to the top "tier" of insurers' provider networks as­ sembles other similar practitioners to form a provisional ip a. the doctors sign onto a public letter to the state's congressional delega­ tion and beneficiary advocates promising that they can outperform the state's other doctors and asking that if they succeed, that they be carved out for a higher update the following year. senator burton secures passage of a bill recognizing the ip a as an accountable care organization and ordering cms to assign the doctors' current and future medicare patients to the aco and to collect risk-adjusted statistics on utilization and outcomes for the ipa's patient popula­ tion over the coming year so that the doctors can be considered for a separate update calculation. the competitive dynamic approach carries many intriguing possibili­ ties. because of its informality, it could be used immediately-beginning with the current legislative cycle surrounding a "fix" for the sgr. it can utilize existing measures for assessing efficiency, quality, and patient­ centeredness (although there likely would be disagreement over exactly which measures to use and how to weight them). by localizing medicare policy, it would air the interests and viewpoints of local stakeholders­ including beneficiaries-who are probably unaware of how their local med­ ical community measures up in terms of the quality of care they receive and its cost, which is reflected most notably in coinsurance and which varies greatly. it has the potential for empowering grass-roots groups of benefi­ ciaries to support or oppose their own doctors' pay updates based on the costs and quality of medical care on a community-by-community basis. it is worth noting here that two health policy initiatives embraced by the obama administration in early 2009 encourage virtual integrated deli­ very systems and may constitute small steps in the direction of accountable care organizations. the first was the health information technology for economic and clinical health ("hitech") program enacted in the american recovery and reinvestment act67 to spur adoption of electronic health records. con­ gress apparently followed the urging of hit innovators to use communities as the locus of new "health information technology regional extension 67. american reinvestment and recovery act of 2009, pub. l. no. 111-5, 123 stat. 115 (2009). 2010] "shared accountabr.ity" approach 217 centers.'.68 this approach follows the model of the massachusetts ehealth collaborative, which built its three demonstration projects around hospitals and associated phos or ip as. massachusetts ehealth collaborative was funded by blue cross/blue shield of massachusetts, which as noted earlier instituted an "alternative quality contract" initiative, a private-sector var­ iation on the aco theme. the llltech program provides seed money and enhanced medicare payments to physicians for a limited period, but contemplates the self­ sufficiency of each extension center when that period expires. the llltech systems could theoretically achieve cost-neutral efficiencies on two dimensions. first, efficiency savings could be reaped by physicians themselves, in which case physicians would be willing to pay to sustain the ehr system. this seems unlikely-most observers believe that lllt effi­ ciency savings are external to physicians.69 the second source of savings would be savings to payors from avoidable injuries, hospitalizations or dup­ licative tests which, to be plowed back into lllt operating expenditures, would have to be shared with providers in some type of aco arrangement. the other new initiative is the call in president obama's budget doc­ ument for providers to assume shared accountability for hospital readmis­ sions. 70 the document is vague but appears to be endorsing two medp ac recommendations on this subject.71 one is to "bundle" payments to a hos­ pital and other providers who take care of a patient upon discharge; the oth­ er is to penalize hospitals for what is deemed an excessive volume of avoidable readmissions. both encourage greater coordination of care fol­ lowing a hospital discharge. these initiatives do not envision shared ac­ countability on the scale of an aco but, like the hit program, nudge providers in the direction of integration by forcing them to build connec­ tions. vi. conflicts likely to arise in a shared accountability regime the discussion above describes conceptually how a well-designed aco regime might move to an equilibrium point at which each system ac68. farzad mostasbari & micky tripathi, achieving meaningful ehr use: leveraging community structures, iheai.:m:beat, feb. 10, 2009, bup:/lwww.ihealthbeat.oj:wperspectivesl 2009/acbieving-meaningful-her-use-leveraging-commty-s1ructures.aspx.. 69. congressional budget office, evidence on tile costs and benefits of healrn information technology 17-18 (2008). available at http://www.cbo.gov /ftpdocs/9lxxl doc9168/05-20healthit.pdf. 70. 0mce of mgmt. & buooet, execunve office of tile president, a new era of resl'onsibiuty: renewing america's promise {2009) available at http://www.gpoaccess.gov/ usbudget/fyl olpdf7fyl 0-newera.pdf 71. see medicare payment advisory commission, report to tile congress: reforming tile delivery system (2008), available at http://www.medpac.gov/documents/ jun08 _entirereport.pdf. 218 indiana health law review [vol. 7:185 tor's financial incentives align with efficiency and quality. needless to say, any flaws in the reward and punishment structure could result in unintended negative consequences. moreover, even a perfectly-designed structure would involve a painful transition period of "creative destruction" during which many conflicts would arise. a system of mandatory, local-level acos based initially upon extended hospital medical staffs would have the greatest potential for re­ vamping the delivery system but would also carry with it the maximum op­ portunities for conflict. many consequences could flow from the individual doctor's choice of aco with which to affiliate. there may be some hospitals with such poor reputations for quality or inefficiency that, under an aco regime, doctors will no longer be willing to affiliate with them. the aco regime could effectively destroy some hospitals' economic viability. in these circums­ tances, local government officials could have to determine whether to let the hospital close or attempt to reconstitute in some way-for instance, as a less-than-full service facility providing emergency care or other services essential to the nearby community. in this scenario, local governments may need funds to subsidize the facility. doctors with privileges only at a closed hospital would have to find another aco, and some may need to have admitting privileges at the base institution to join another aco. credentialing committees, in deciding whether to accept displaced doctors, would presumably consider two main factors: the optimum number of doctors needed to maintain satisfactory access to beneficiaries (assuming that carps access scores are one of the performance bonus criteria), and the likelihood that the individual doctor would add to or subtract from the aco's efficiency and quality. therefore, the aco proposal contemplates the possibility that in high utilization areas, not only will facilities close but also, some doctors will have to relocate to underserved areas or leave the practice of medicine. trickier issues still are raised by diverging interests of the doctors and the hospital to which they are attached. a localized sgr and shared sav­ ings regime mean the doctors' gains come at the hospital's expense. the aco regime is based on the premise that hospitals in high-utilization areas will resign themselves to downsizing and cooperate with doctors by allow­ ing their infrastructure (primarily, their committee structure and support units) to be harnessed for efficiency and quality improvement efforts. however, hospitals could try to block these efforts. for instance, hospitals will be busier with more interventionists in their aco pool and will earn the most if doctors who perform profitable procedures continue to do so at a high volume. in contrast, doctors in the aco can boost their conversion factor most quickly by identifying procedures that are performed at very high rates relative to the rest of the nation and curtailing them. to illustrate, imagine an aco formed around a hospital such as ely­ ria, ohio's emh regional medical center, which recently gained notoriety 2010] "shared accountability'' approach 219 for performing angioplasties at four times the national rate. according the new york times, about 1,000 such procedures are performed on medicare patients there each year.72 using numbers reported in the article, it appears that if the rate were pared down to the national average, the number of pro­ cedures would be around 250 and some $600,000 in savings would be made available for the aco's doctors to share in the form of a higher conversion factor. such a reduction, however, would cut the hospital's revenues by as much as $8 million-a substantial portion of the hospital's profits. aco doctors would presumably act through the hospital's committee structure to reduce capacity. the hospital could attempt to block such a maneuver, but aco doctors would still be able to stop referring patients for angioplasties or affiliate themselves with a competing aco. a desirable consequence of such conflicts would be a new demand for clinical effectiveness data. cardiologists whose practice would be threat­ ened in these scenarios would have an incentive to fund research demon­ strating the value of performing their procedure on a wider array of patients. if they were able to demonstrate that the procedure was reducing mortality in the population served by the aco, they could argue that they were help­ ing the aco to earn a performance bonus. protracted conflicts could lead to litigation and perhaps even to inter­ ruptions in access to care. also, it would be expected that some hospitals would close their doors. it might be necessary for an aco regime to in­ clude local health care "czars" with the power to mediate and arbitrate dis­ putes, or order "cooling-off periods,'' much as occurs in the labor sphere. as has been noted by others, quality measurement efforts can lead to increased costs to medicare. 73 in one category of measurements are im­ proved outcomes with quantifiable savings to medicare, e.g., avoided hos­ pitalizations. it is relatively easy to reward this quality dimension, by awarding shared part a savings to the acos that achieve it. but a second category of quality indicators coinprises processes recommended for the care of certain illnesses that will not, in the short run at least, lead to cost savings and that, because they are under-used, will certainly lead to higher costs. one example might be "colonoscopic surveillance after colon cancer." in a third category are improved outcomes that benefit the popu­ lation served and thus have economic value to society but not a value that is reflected in lower medicare costs. examples here are mortality rates for medical conditions or surgical procedures these latter categories create dilemmas because they either require additional medicare expenditures for underused services, or merit increased 72. reed abelson, heart procedure is off the charts in an ohio city, n.y. times, aug. 18, 2006, at al, available at http:!www.nytimes.com/2006/0818/business/18stent.html. 73. see, e.g., albert h. guay, understanding pay for performance, ada news today, feb. 13, 2007. http://www.ada.orglprof/resourceslpubs/adanews/printarticle.asp ?articleid=2344. 220 indiana heal til law review [vol. 7:185 pay. to doctors to incent their achievement, or both. since they cannot be paid for by self-generated savings they must be paid .for either by transfer .. ring existing funds from low-performance regions or by committing new money. , , yet another question is whether a system of sub-national sgr pools would have any more viability than the current sgr regime, from which doctors have been able to engineer breakouts on an annual basis. as an artificial legislative construct, the sgr has been .vulnerable to what might be called a circumvention strategy by doctors-lobbying con­ gress to "replenish" the pool by reversing negative updates. attempts to circumvent the sgr by lobbying should have been foreseen by policymak­ ers. an earlier analog to the sgr, the allowable sale quantity (asq) re­ gime governing sustainability of national forests, had proven vulnerable to circumvention by logging interests, most notably in 1995 when the "salvage rider'' was enacted.74 the politics of the salvage rider and the politics of the update reversals are strikingly similar: the affected interest group protests that restrictions are too onerous and a "crisis" threatens the public; in the case of the salvage rider, unemployment; in the case of the negative update, reduced access to care. if the asq can be circumvented despite vociferous opposition from environmental groups, it is all the more unrealistic to expect that the sgr will not be. circumvented given that the doctors' lobbying has faced no or­ ganized opposition. the biggest questiop. raised by the shared accountabili­ ty approach to the sgr is whether doctors would alter their practices to comply with the spirit of the new regime, or continue to try to "beat" the system by maintaining or increasing volume and then pleading for relief from the resulting "crisis." there is no legal barrier preventing congress from abrogating a statu­ tory scheme that it created. there are practical barriers, however, that can prevent an interest group from succeeding in a circumvention strategy. the "crisis" must get on the congressional agenda, and members of congress must be sympathetic. for an sgr regime to remain secure from circumven­ tion, it should refrain from creating a compelling focusing event that can create a crisis atmosphere, and it must.command respect and legitimacy that enable it to withstand frequent attacks. currently, the sgr results in nega­ tive updates for every doctor in the country, allowing doctors to mount na­ tionwide campaigns themed around the message of a nationwide access-to­ care threat. this message gains a sympathetic hea,ring because few believe that 600,000-plus u.s. doctors are capable of acting in concert to maintain steady utilization, and consequently appear blameless for their impending cutinpay. · 74. don hopey, vote near on rule allowing more national forest logging, pitts­ burgh post-gazette, jul. 29, 1996, at bl. 2010] "shared accountabu..rry" approach 221 the splitting of the nationwide sgr pool into smaller pools would probably be a· step toward eliminating both of these conditions. with smaller pools, doctors would no longer be affected uniformly by a negative update. presumably, doctors in the ''benchmark" localities identified by dartmouth would receive positive updates simply by practicing as they have in the past, and would have no reason to quarrel with the system. in­ stead, negative updates would be limited to a subset of doctors in high­ intensity utilization regions, and complaints from this smaller number of doctors would carry less political weight. this is not say that members of congress from those regions would not be willing to step in and advocate for local doctors, especially if the cost of reversing a negative update could be spread nationwide. but if the loca­ lized sgr system gave doctors real tools to control their destinies, their pleas for relief would be less well-received. giving doctors the opportunity to choose their ehms pool or opt into a separate ip a pool would be impor­ tant to creating a sense that ·doctors are not victims of but rather agents of the negative update's onset. congressional particularism is easiest when benefits are concentrated and costs are diffused.75 but with sub-national sgrs, efforts by a member of congress or the hhs secretary to give a positive update to physicians would have concentrated benefits and concentrated costs-increases in co­ payments for medicate beneficiaries within the locality and possibly in­ creased premiums as well, if congress or the secretary conditioned the pos­ itive update on its costs being recovered from within the service area affected. vll. conclusion a shared accountability regime holds out the promise of improving ef­ ficiency, quality, and patient-centeredness while preserving two additional values of critical importance to stakeholders-autonomy for doctors and choice for patients. other models of cost-containment have been perceived to require sacrifices of one or more of these values. the shared accountability approach also addresses critiques of the medicare from two often disgruntled factions of the program's observers. an intriguing possibility is that accountable care organizations might bridge the divide between defenders of traditional medicare and doctrinaire con­ servatives, who would prefer either a voucher/subsidy approach ("premium support") or consumer-directed approach (''medical savings account") that minimizes the federal role in providing health care. because payments to physicians could vary greatly from the prices in medicare's fee schedule 75. seer. douglas arnold, the logic of congressional action (yale university press 1990). 222 indiana health law review [vol. 7:185 depending on the aco's performance, and players within the aco would be free to provide services, such as care coordination, that are not covered by medicare's fee schedule, the aco regime could effectively revoke med­ icare's administered pricing system, making the schedule a reference point for payment instead of the last word. such a development would be wel­ come to conservatives. john goodman appeared to endorse the aco con­ cept in a wall street journal op-ed, writing under the current system, medicare and medicaid stifle entrepreneurial activity and financially punish efforts to lower cost or improve quality. why can't these agencies reward improvements instead? sup­ pose an entrepreneur offered to replicate the mayo clinic in other parts of the country-potentially sav­ ing medicare 25% of costs and improving quality of care along the way. medicare should be willing to pay, say, 12.5% more than its standard rates in order to achieve twice that amount in total lower costs.76 accountable care organizations could also address the desire of health policy experts for what james robinson has called "payment methods that blend collective capitation with individual fee-for-service."77 robinson noted that "the formation of virtual specialty departments that can be as­ signed a predetermined budget"78 would lead to individual specialists in these virtual depart­ ments ... [thinking) of each other as collaborators, not simply as competitors, and will [provoke them to] ... begin to adopt specialty-specific clinical protocols ... ideally, this improves the cost-effectiveness of the services provided, since peer monitoring and dis­ ciplining of inappropriate behavior is easier within specialty lines than across them. it provides a spur to the creation of specialty protocols, the screening and selection of departmental members, cross-specialty discussions of what constitutes an appropriate refer­ ral, and, more generally, the first whispers of collec­ tive professionalism in what traditionally has been the 76. john c. goodman, "perverse incentives in health care," wall street journal, aprils, 2007. 77. robinson, supra note 52, at 161. 78. id. 2010] "shared account ability" approach 223 most autarkic of occupations. 79 the accountable care organization approach offers the possibility of the blended payment system that robinson and other health policy analysts have advocated. while no one can say whether a full-blown aco system would ac­ complish all the goals discussed in this paper, the availability of informal means of testing the concept, as through the medigap or "competitive dy­ namic" options outlined above, means that there are opportunities to expe­ riment with shared accountability on a limited or voluntary scale. 79. !d. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i competition policy in health care in an era of reform max huffinan1 introduction health care reform recently has been signed into law by president ob­ ama. the signing concluded a tortuous legislative process involving false starts, recriminations, accusations of stonewalling on one side and "ram­ ming" using "dirty tricks" on the other, threats of filibuster, and fear of electoral response.2 passage of health care reform legislation is just the be­ ginning. as with all major legislation, there will be many years ofleaming what the new law means in application.3 and the absorption process for the second-order regulatory scheme of antitrust will be even slower.4 we in1. associate professor and dean's fellow, indiana university school of lawindi­ anapolis. for assistance and support in putting on the think-tank discussion and public panel to which this introduction relates, thanks to the indiana university school of lawindian­ apolis, and especially dean gary roberts; the hall center for law and health and its faculty co-directors eleanor kinney and david orentlicher; staff at the school of law, including joanna macdougall, liz allington, shaun ingram, faith knotts and lauri turner; and heather mccabe and carsandra knight from the hall center. thanks to albert a. foer, president of the american antitrust institute, and to aai itself for their efforts in hatching this idea, moderating the public panel and bringing together an unparalleled group of experts for our day of meetings. thanks to john connor for originally proposing an event co­ sponsored by the iu school of lawindianapolis and aai, and for his help and guidance in seeing it through to fruition. thanks to syd arak, david balto, joe bauer, william com­ anor, ted frech, tim greaney, cliff johnson, paul london, emily morris, greg pemberton, gayle reindl, barak richman and chris sagers for taking time from their schedules and giving so generously of their expertise. further funding and support was provided by the office of iupui vice-chancellor kody varahramyan and iu common share. as usual, while the academics have their fun, the hard work falls to the students. many thanks to 3l students brian bouggy and julie mahomed of the iu school of law indianapolis, and to the staff of the school's health law review, for their extraordinary work in making the event and this publication a success. 2. see ceci connolly, "61 days from near-defeat to victory," washington post, mar. 23,2010, at al, a6 (detailing the "twists and turns of president obama's signature domestic issue" from summer 2009 through passage by partisan. vote on march 21, 20 i 0); dana mil­ bank, "the republicans who stirred the tea," washington post, mar. 22, 2010, at ai, all (describing "one of the ugliest and strangest periods the american legislative process has ever experienced"); cf. thomas greaney, "health reform, a class act," health reform watch web log, march 24, 2010, available at http://www.healthreformwatch.com/2010/ 03124/health-reform-a-class-act/ (visited march 28, 2010) (noting "pseudo-journalism" and misinformation about health reform after its passage). 3. that is especially so because many provisions of the reform bill do not take effect for several years. see, e.g., patient protection and affordable care act, h.r. 3590 (2018 effective date for tax on cadillac health insurance plans). 4. as a fundamentally common-law scheme, antitrust develops through court deci­ sions over many years, such that even issues first decided nearly a century ago maintain remarkable currency. see, e.g., leegin creative leather prods., inc. v. psks, inc., 551 u.s. 877 (2007), overruling dr. miles med co. v. john d. park & sons co., 220 u.s. 373 226 indiana health law review [vol. 7:225 troduce here the transcript of a panel discussion, held on december 10, · 2009, which we believe is the first broad (if not comprehensive) analysis of the competition policy implications of health· care· reform. these pages provide a road map for correctly analyzing many of the antitrust issues that have arisen in health care previously and are· certain to arise in health care as reformed. understanding how to analyze these issues could not be.more impor­ tant. as panelist paul london wrote in 2001, "[r]eal competition in health care would stimulate the american economy."5 london noted the competi­ tion picture raised questions about insurance; providers doctors and hos­ pitals, technologies and information systems, and regulatory approaches.6 to this end we convened a rare gathering of think-tankers/ academic economists,8 law, business and medical school professors,9 and practition­ ers/0 all with deep expertise in the arenas ofhealth law, antitrust law, and in -many cases, both. several of our participants came originally from the world of government antitrust enforcement. we gathered for an entire day, initially for several hours in a private think-tank style discussion, and later in a public panel discussion. during both sessions, topic leaders introduced a particular genus of issues on which they previously had submitted written work to the group. the topic leaders then described some possible resolu­ tions· to those issues, and the group engaged in. the discussion. in the after­ noon session, the transcript of which follows, we reprised some of the same discussion, but our public discussion was neatly distilled by the morning's conversation. on december 10, 2009, the health care reform picture was uncertain. as bert foer said at our public panel held on that day, ''when we set this up months ago, we didn't know whether there would be a law or not. and you know what? we still don't know which means between the house and the senate and a conference committee that may or may not be joined, we don't-know what this law is that we are talking about today."11 the house of representatives had passed h.r. 3962, the "affordable health care for ( 1911 ). see -also max huffman. a retrospective on twenty-five years of the foreign trade a,ntitrust improvements act, 44 hous. l. rev. 285,289 (2007) (noting antitrust courts' expe­ rience in advancing doctrine through common-law analysis rather than statutory interpreta­ tion''). 5. paul a. london, the competition solution 187 (2001). 6. !d. at 19()..95. 7. including bert foer, president of aai, and david balto, senior fellow, center for american progress. 8. bill comanor, ucla and ted frech, uc santa barbara. 9. joe bauer, notre dame law school; david orentlicher, iu school of lawindi­ anapolis, and adjunct professor, iu school of medicine; barak richman. duke university school of law and fuqua school of business; tim greaney, saint louis university school of law; christopher sagers, cleveland-marshall college of law; emily morris, iu school of lawindianapolis; and max huffman, iu school of lawindianapolis. 10. gayle reindl, taft, stettinius & hollister llp; greg pemberton, ice miller llp; cliff johnson, hall, render, killian, heath & lyman pc; and syd arak. 11. llffra at 236. 2010] competition policy in health care 227 america act," a month prior.12 legislation stalled in the senate panelist joe bauer noted it was "sailing through the congress, but ... at glacial speed,"13 and at the time of our meeting, it was unclear whether health care reform would succeed at all, let alone in something resembling what con­ gress and the white house had been contemplating. meeting as we did with the reform picture uncertain might have seemed a risky proposition. "it might be that we are wasting our time and that there will be no law."14 but such a concern arose only theoretically. when we originally discussed this project, we knew we might be discussing reform that would not happen this year. we also knew that health care reform of some sort was an eventual certainty, because the then-current sys­ tem was not sustainable in the long run. and we know above all that the competition policy concerns that were the primary subject of our· discus­ sions transcended any particular time or legislative proposal. this introduction introduces the substantive discussion that was tran­ scribed during our afternoon public panel discussion. we divided our dis­ cussions roughly into four topics. first was the idea of health care reform from the perspective of the consumer of health care. barak richman served as our topic leader, and presented during both sessions (as did each of the topic chairs) on his analysis of the consumer of health services. second, chris sagers discussed his writing on the health care insurance marketplace, with a particular emphasis on the possibility and implications of a repeal of the mccarran-ferguson act, at least as it relates to health care and medical malpractice insurance.15 david balto discussed his analysis of the antitrust enforcement picture. finally, tim greaney led the discussion about pro­ vider competition. the then-extant reform picture part of the process of discussing competition policy in health care reform necessarily was our developing an understanding of the reform pic­ ture that currently existed and was likely to emerge. david orentlicher dis­ cussed the reform process, to the extent it was knowable on december 10. an important lesson from that introduction was the low probability that reform would meet the lofty hopes many had set for it. "i guess the inter­ esting thing after hearing all the series of concerns that barak has laid out nicely is how few of them are being addressed in the healthcare reform pro12. h.r. 3962, nov. 7, 2009. 13. infra at 263. 14. infra at 236. 15. sagers' written analysis is forthcoming in his essay, much ado about probably very little: mccarran-ferguson repeal in the pending health riform legislation, 28 yale l. & pol'y rev._ (forthcoming 2010), available at ssm.com/abstract=1546056. 228 indiana heal til law review [vol. 7:225 posals."16 orentlicher even suggested that one possible impact would be that by forcing new customers into a flawed system, the extent ofits flaws would become untenable, and perhaps in the future, real reform might emerge.17 that half-hearted optimism found support in others' remarks as well. william comanor expressed disappointment that reform efforts threatened to ''prop up the existing system of prepaid healthcare which is called health insurance but which isn't health insurance at all."18 like orentlicher, comanor saw some possible benefit in a crisis in care, which might undo the "the rather bizarre way that we finance healthcare through the employ­ ment contract." showing that approach was a vestige of the post-world war ii era, he believed that system was self-destructing.19 and in a ques­ tion-and-answer involving this author, barak richman discussed the eco­ nomic impact of the influx of new consumers in the system. to the extent that insuring current uninsureds will increase their use of health care servic­ es, costs may well increase once again leading to the possibility that reform as we have seen may be unsustainable in the long term. 20 we heard about some of the different possible approaches to opening access to health care. one was the veteran's affairs healthcare system, "the british system brought over to the u.s.... it's not very convenient care, you might have to travel ... to get your care, but you'll get good care:m another was the "german/dutch/massachusetts model. we make sure everybody is insured by requiring them to be insured. "22 in the case of the latter approach, insurance must be available if it is to be required. that entails making insurance available for the asking, including creating a mar­ ketplace "where insurance companies will have to meet certain qualifica­ tions and they can sell their plans . . . . [t]he government has screened and made sure these are plans that provide good quality coverage." the mar­ ketplace "hopefully will generate competition" and the consumer benefits that flow from it.23 the operation of the new insurance marketplace is an area of consi­ derable uncertainty. the so-called insurance "exchange" exists to allow individual purchasers whose employer does not offer insurance· to purchase it on their own. purchasing on the exchange, in theory, those individuals will not suffer discrimination on the basis of pre-existing oonditions and they will be able to afford insurance because prices will be lower and subsi16. infraat244. 17. id. 18. infra at 261. 19. id. 20. infra at 271. 21. infra at 244. 22. id. 23. infra at 246. 2010] competffion policy in health care 229 dies will assist them. 24 the driving features of the proposed reform that orentlicher discussed included requirements imposed on individuals to become insured or pay a penalty; requirements imposed on employers to offer insurance; require­ ments placed on insurers to make insurance available; and subsidies pro­ vided by the government to decrease the costs of these requirements. 25 many. variables threatened to undermine complete success in reform, if ad.opted as proposed. not surprisingly, the most substantial of those was cost. orentlicher noted the tendency of policy-makers to follow the ap­ proach of "expand[ing] access now, deal[ing] with costs later, but that doesn't always work, because it tends to unravel over time, becomes unaf­ forc;table. that was what happened when oregon expanded its healthcare, they tried it, it worked for a few years and then, when they ran out of mon­ ey . . . . when the economy turned, they couldn't afford to pay for the ex­ panded access and their level of uninsureds is high as it was when they started. "26 the consumer . one of the greatest difficulties in antitrust relates to what may be its most basic tenet. antitrust law exists to protect consumers.27 that proposi­ tion appears to hold in every jurisdiction with an antitrust scheme.28 but what consumer protection means in antitrust remains poorly understood.29 barak richman argued the difficulty of defining the consumer protection role of competition policy is all the greater in the health care arena.30 that is not surprising. health care consumer policy uncomfortably straddles the fence. between pure consumer protection regulation and competition policy. i have recently argued that fence defines the line between enhancing and decreasing consumer choice.31 requiring consumption of health services, on pain of penalty, is a measure that protects consumers even while under­ mining their freedom of choice. the problem is exacerbated in part because "as we start thinking about consumers, what emerges is a multi-headed, multi-conflicted, multi­ incentivized entity that suffers from a great deal of confusion. '.32 richman showed how consumers filled at least three capacities. one is th~ "consum-. 24. infra at 264-266. 25. infra at 243-246 26. infra at 248. . . . 27. max huffinan, bridging the divide? theories for integrating competition law and consumer protection, 6 ew'opelltl. competition journal?,_ (2010). 28. /d. 29. ld. (citing sources). 30. infra at 238. 31. huffinan, supra n.25, at i 0-11. 32. infra at 238. 230 indiana health law review [vol. 7:225 er as a purchaser of insurance"; a second is "the consumer as the patient"; and the third is "the consumer as the voter."33 these different capacities give rise to an irreconcilable tension: purchasers want cost low; patients want quality high; and voters prefer to limit subsidies. competition policy becomes very difficult where the consumer's di­ rect interface is with the insurer, and the insurer interfaces (at least in terms of payment) with the provider. a monopoly provider market with a com­ petitive insurer market threatens the circumstance that the consumer's voice with the provider is unable to protect the consumer's interests. richman noted that theoretical and empirical evidence suggested the possibility that bilateral monopoly was better than diffuse insurers interfacing with concen­ trated providers.34 competition in insurance presents another concern. it is possible "too many contracts would create information overload."35 rich­ man also. noted the problem of consumers being informed and given rea­ sonable and understandable decisions. "[w]e're a long way from that." david balto echoed that sentiment: "in terms of transparency, good luck!" these are problems in "creating some kind of vibrant market for health in­ surance."36 the story is not much better in the provider marketplace, where con­ sumers as patients do their shopping. the best providers ''the best price quality combination in america has generally been· with these integrated systems like kaiser or mayo ... where the insurer and the provider are the same entity"are in "short supply."37 this reflects a poorly-functioning marketplace for "competition that would encourage consumers as patients to exercise their rights. "38 antitrust immunity in the insurance marketplace we also undertook a narrower focus on the exemption from federal antitrust regulation enjoyed by insurers under the mccarran-ferguson act.39 repeal or partial repeal of the mccarran-ferguson act was intermit­ tently part of the reform picture through 2009; as of our meeting on de33. infra at 239. 34. infra at 239. 35. infra at 240. cf remarks of cavendish elithom, fourth antitrust marathon, 6 european competition journal 1, 29 (2010) (noting the understanding of the uk office of fair trading that "excessive choice can lead to less consumer activation in the markets and that is a source of detriment"). 36. infra at 240; id. at 251 (transcript 21) (remarks of david balto); cf edward j. janger & susan block-lieb, consumer credit and competition: the puzzle of competitive credit markets, 6 european competition journal 68, 71-72 (2010) (discussing the lemons equilibrium in competition in consumer mortgage lending flowing from lenders' competition on the opacity, rather than quality, of contract terms). 37. infra at 241. 38. infra at 242. 39. 15 u.s.c. §§ 1011-15. 2010] competition poucy in health care 231 cember 1 0,. it appeared most .likely repeal would not be part of reform.. in fact, mccarran-ferguson repeal was not part of the health care bill signed. by president obama, although a free-standing effort to repeal the law, li­ mited to health insurance (and not medical malpractice insurance)· is pend­ ing in congress as of this writing.40 mccarran-ferguson immunity is not specific to health insurance, but the current "repeal effort ... has been.seen all along as part of healthcare reform.'.41 the repeal was discussed only to "apply to carriers in health insurance and medical malpractice insuiwlce," and "it might apply to only some of their conduct. '.42 mccarran-ferguson immunity came about in 1945, as joe bauer noted, in a bill signed by president roosevelt not long before his death.43 chris sagers explained that, at the time of its enactment, immunity. from antitrust was· considered necessary on the basis of the economic .theory of . "destructive competition," applied to capital-intensive industries.44 the exemption can also be justified if one has faith in the ability of states to re­ gulate local industry effectively.45 experience undermined the story of the states as effective regulators of insurance ''probably one of the saddest parts of mccarran-ferguson is that the amount of regulation by the states necessary to enjoy that exemption has been minimal. •.46 during the daytime session, we discussed seemingly overt circumstances of the state insurance commissioner position being a political spoil for campaign donors. the. result is inadequate regulation by the states, and, as sagers noted, ''there doesn't seem to be much doubt that in health insurance we don't have a competitive marketplace at all.'.47 whether repeal could be effective is another story. as of our discus­ sion on december 10, repeal efforts tended to be targeted at specific catego­ ries of egregiously anticompetitive conduct price fixing, bid rigging and market allocation which arguably are outside the statutory exemption for the "business of insurance," and therefore illegal even under mccarran­ ferguson.48 also, repeal would take place in highly concentrated markets, 40. health insurance industry fair competition act, h.r. 4626, lllth cong., 2d sess. (feb. 22, 2010). 41. infra at 250. 42. chris sagers, much ado about probably pretty little: mccarran-f.erguson re­ peal in the pending health reform legislation, 28 yale law & pol'y rev._ (forthcoming 2010), draft at 1, available at ssrn.com/abstract=1546056. 43. infra at 249; id. at 260, 44. sagers, supra n.42, at;_ (draft at 5). that theory bas been largely debunked since. 1945. see id. at 7; cf. daniel h. cole & peter z. grossman. principles oflaw and econom­ ics 306 (2005) (questioning the reality of natural monopoly). 45. cf. id. at 6 (noting "trends" that ''had already led to rate-and-entty regulation in markets throughout the u.s. economy"). 46. infra at 263; see also sagers, supra n.42, at_ (draft at 8-9) (regulation sufficient for mccarran-ferguson act purposes ifthere was "some regime of state oversight," even if not fully effective). 47. infra at 249; id. at 250-251; see sagers. supra n.42, at 11-12. 48. infra at 249-252; id. at 261. the pending mccarran-ferguson repealer legislation 232 indiana health law review [vol. 7:225 where it seems unlikely competition would immediately take hold. sagers argued repeal would be a salutary phenomenon in any event. in the long term, competitive conditions might arise, and having repealed the exemp­ tion, even if only narrowly, would help that competition to flourish. sagers also noted the important signaling value of repeal, which would be "a pretty strong message to the justice department or the federal trade commission to actually do something. "49 enforcement the discussion of antitrust enforcement was largely pessimistic, al­ though, as david balto noted, "[c]ompetition·and consumer protection en­ forcement is important, because we want markets to work effectively .... [n]o one has so far disagreed with me on this diverse panel .... "50 in the case of health insurance, balto and sagers both noted the high level of con­ centration in the industry, where "[o]ver 400 mergers in the past eight years ... has led to this tremendous degree of concentration."51 with re­ gard to insurance, it is, of course, impossible to uncouple concerns for anti­ competitive behavior from the antitrust exemption for insurance under the mccarran-ferguson act. immunity was therefore an important part of our conversation. 52 in addition to competitive concerns in health insurance, balto noted the role of consumer protection regulation. concerns for conflicts of inter­ est arise, because insurers ostensibly representing patient interests have in­ centives to limit care that might be in those patients' best interest. health insurers may be engaged in fraudulent conduct, but federal trade commis­ sion resources are devoted to "fraudulent advertisers who tell you that if you take this pill, you'll lose 20 pounds over the next week." states lack the resources to enforce either antitrust or consumer protection prohibitions against the insurance industry "over a third of all states have never brought a single consumer protection action against fraudulent or deceptive activity by health insurance companies and something like 95% of the ac­ tions were brought by just four states.''53 finally, balto cited the ftc's "secret weapon" section 5 of the ftc act, which gives that agency an is not so limited. see h.r. 4626 (2010). 49. infra at 252. 50. infra at 253. 51. infra at 254; id. at 249; see also sagers, supra n.42, at 11-12 (noting 400 mergers "in the past 14 years") (citing, inter alia, am. med. ass'n, competition in health insurance: a comprehensive study of u.s. markets, 2007 update (2007)). the concentration concern implicates barak richman's comments about the possibility that a bilateral monopoly is preferable to a concentrated provider market and a competitive insurance market see supra nn. _-_and accompanying text. 52. see infra nn. _-_and accompanying text; infra at 246-250. 53. infra at 255. 2010] competition poucy in health care 233 ostensibly broader mandate than the antitrust laws. 54 gayle reindl noted, and discussion during our day program supported the point, that the ftc has been quite active in one area of health care anti­ trust, which is that having to do with so-called pay for delay settlements between brand-name and generic pharmaceutical manufacturers.55 those settlements have the effect of splitting the profits from the monopoly the brand-name manufacturer is able to preserve by paying the generic to delay entry into the market in competition with the brand-name drug. it is the courts, not the ftc, that have held up enforcement in that arena. reindl's comment makes an important point: even a highly reinvigo­ rated enforcement regime must contend with a judiciary that may be hostile to antitrust enforcement. 56 tim greaney noted that case law has not been friendly to a vigorous enforcement agenda against such abuses. 57 chris sagers, during a question-and-answer colloquy, went further: "my sense is there has evolved very quietly a case law for healthcare, and particularly for hospitals, that is in a lot of ways special. it's not a statutory exemption, ob­ viously, but it is arguably a judicial one.'.s8 except for a class of cases that are in reality tort, contract or employment claims by doctors against hospit­ als, 59 other health-care antitrust case law threatens to limit enforcement against anticompetitive conduct by providers. aai recently has carefully examined the question of antitrust en­ forcement in health care. in competition in the unhealthy health sector, one chapter in aai's transition report on competition policy,60 aai made recommendations with regard to healthcare intermediaries, pharmaceuticals, providers including physicians and hospitals, and government involve­ ment both regulatory and with regard to the government as a market par­ ticipant. the upshot of the aai recommendations, which was echoed broadly during our meetings on december 10, is the need for "[g]reater re­ sources" to "be devoted to health care antitrust enforcement.'.61 provider competition tim greaney led the discussion of provider competition with the ob­ servation that among hospitals, doctors and pharmaceutical manufacturers, 54. infra at 256. 55. infra at 260. 56. see also infra at 270 (citing bell atlantic corp. v. twombly, 550 u.s. 544 (2007), and american needle v. nfl, s. ct. no. 08-861 (argued jan. 13, 2010)). 57. infra at 259. 58. i7!fra at 270. 59. greaney referred to these cases as "the junk food of antitrust" and applauded the decisions dismissing many of them. id. 60. american antitrust institute, transition report on competition policy 317-48 (2008), available at www.antitrustinstitute.org. 61. id at 321. 234 indiana health law review [vol. 7:225 "competition does matter . . . . [w]e do have evidence that the competition has lowered cost.',(j2 the corollary point is, of course, the impact of a lack of competition on costs. "[h]ospital mergers ... have raise costs from 540% in the markets in which they have occurred. '.63 but greaney also noted the tension between concentration and "frag­ mentation.'' in the case of the latter, physicians practice either solo or in small groups, so ''there's very little care coordination." the solution to the latter appears to be vertical integration, whereby physicians, nurses, social workers, alternative care providers and hospitals coordinate care efforts. that kind of bundling can be tremendously good for care, as barak rich­ man had noted earlier with regard to the famous success stories of inte­ grated providers kaiser and mayo.64 the aai, in its transition report, echoed greaney's view of the value of "efficiency-enhancing integration where the result is more cost-effective, higher-quality delivery of care.'.65 in addition to increased concentration, greaney noted the ability of an "entity with market power [to] exclude others.'.66 such concerns for abuses of dominance underlay much of the discussion on december 10. examples of abuses of dominant positions arise in hospital marketplaces. those may include raising rivals' costs, with the impact of limiting competition. tying arrangements that leverage market power into other markets may permit hospitals to avoid limits on medicare reimbursements. and hospitals have incentives to limit competition by physician-controlled specialty hospitals. 67 finally, concerted activities by providers that do not serve to benefit consumers thiough efficiency-enhancing integration continue to present concerns. "an examination· of cases brought over the last thirty years re­ veals that ... overt cartelizj:ltion schemes [involving physicians] have not disappeared and in fact may have increased in recent years.'.68 it is thus ne~essary, aai says, to ensure "sufficient sanctions to deter future wrong­ domg.'.69 * • • * * the foregoing serves only to provide a short summary of the discus­ sion on december 10, 2009. the following pages comprise the transcript of the public panel discussion held that day. 62. infra at 257. 63. id. 64. infra at 241; see supra nn. _-_and accompanying text. 65. transition report, supra n.4 7, at 340-41. 66. infra at 258 .. see generally jefferson parish hosp. v. hyde, 466 u.s. 2 (1984 ). 67. transition report, supra n.60, at 343. 68. transition report, supra n. 60, at 340 (citing thomas t. greaney, thirty years of solicitude: antitrust law and physician cartels, 7 hous. j. health l. & pol'y 189 (2007)). 69. id at 341. 2010] competition poucy in health care 235 health law roundtable event -competition policy in health care in an era of reform, december 10, 2009, indiana university school of lawindianapolis dean gary roberts: good afternoon everybody. welcome. i am gary roberts, i am the dean of the indiana university school of law-­ indianapolis, and i am here today to introduce and welcome you to this tremendous program we have put together. the school of law and the hall center for law and health, which is one of the signature centers on campus, has partnered with the american antitrust institute, a washington d.c.-based think-tank. in recent years aai has been a leader in advocating for more aggressive antitrust enforce­ ment. we are also gratified to have received some financial support for the program from the campus office of vice chancellor kody v arahramyan and also the iupui endowment fund. we thank them for their support. our speakers today are some of the nation's leading experts on the in­ tersection of health policy and antitrust, and they hail from the law facul­ ties, economics faculties, think-tanks, and private law practice. and they spent almost the entire day up to now in a private, closed-door session, brainstorming about different ideas, and i have been told it was a robust and exciting conversation. i want to tum this over to the moderator oftoday's panel, albert foer. he is the president of the american antitrust institute. bert's varied career has included private law practice in washington, dc with hogan & hart­ son and jackson & campbell; the federal senior executive service as an assistant director and acting deputy director for the federal trade com­ mission's bureau of competition. he's been the ceo of a mid-sized chain of retail jewelry stores. he has also been a prolific author, publishing numerous articles and book chap­ ters. he is a graduate of the university of chicago law school, did his un­ dergraduate degree at brandeis, and he also has a masters degree from washington university. let me tum this over to bert. mr. foer: thank you dean roberts and thank you to the indiana university school of law indianapolis, and particularly to max huffinan, professor at the law school who organized this event. as i think you are going to see -it took a little bit of guts to put this program together because 236 indiana health law review [vol. 7:225 it's pretty experimental. the american antitrust institute is an 11-year-old think-tank in wash­ ingtort we do education, research, and advocacy functions. and we some­ times do brainstorming, trying to figure out what the right questions are to be asking about a topic. that's what we did this morning. we spent about four-and-half hours of this group and a few people who are still here and a few people who've already left. we have been talking about healthcare reform. now, when we set this up months ago, we didn't know whether there would be a law or not. and you know what? we still don't know-which means between the house and the senate and a conference committee that may or may not be joined, we don't know what this law is that we are talking about today. it may be that we are wasting our time that there will be no law. _even if there is no new law at this time, however, there are going to be very sig,.. nificant competition issues that will continue to be relevant and there is no better group than the people sitting here to discuss those issues, to try to pinpoint where the issues are, not necessarily.solve any of them but at least help us identify the key issues that we think you should be looking at. let me say also that some members of the panel are going to have to catch planes before we finish so don't worry if they are walking out, it does not necessarily mean they disagree strenuously with everything they've heard. if i start at my far right where he doesn't belong politically is bill comanor from the university of california, los angeles, and santa barbara. bill is an economist and a former chiefeconomist of the federal trade commission. david balto is a senior fellow at the center for american progress, and he was the policy director of the bureau of competition at the ftc, and the attorney advisor to chairman robert pitofsky for a number of years. he is one of the most brilliant and sometimes outspoken experts in the field of competition policy. if we don't get a chance to hearmuch from him, it's a loss for everyone here. chris sagers is a professor at cleveland-marshall college of .law where he teaches antitrust and administrative law. chris is a new member of the aai advisory board. david balto; by. the way, and bill comanor are both members of the advisory board, and 'ioe bauer from notre dame, as well. joe is: a real ex­ pert in the field of antitrust. he is the author of a major treatise on the sub­ ject, comes to us today from up the road in south bend. 2010] . competition poucy jn heal til care 237 now david orentlicher is your homegrown twofer a lawyer and a doctor. he is professor oflaw and co-director of the hall center for law and health at·the iu school of law -indianapolis, and an adjunct profes­ sor at indiana university school of medicine. terrific background for this discussion. next is barak richman, another and fairly new member of the aai advisory board. he is professor of law and business administration at duke university. he teaches antitrust and healthcare policy. he is the co­ editor of the symposium volume of law and contemporary problems with clark havighurst which was entitled. "who pays? who benefits? :distribu­ tional issues in health care." and then we have thomas "tim" greaney, a member of our advisory board. tim is a professor at st. louis university. he is the charles a. meyers professor of law and director of the center for health law studies at st. louis university, and the author of one of the nations leading health law casebooks, as well as a treatise and hornbook on health law. gayle reindl is local, she is a litigation partner at taft stettinius and hollister llp, where she does antitrust litigation and some healthcare liti­ gation. and finally we have paul london. paul is an economist, a consulting economist and the author of a book called 'the competition solution'. back in the clinton administration he was the deputy under secretary of com­ merce for economics and statistics. that's your group. what we are going to do is start out with barak richman talking from the point of view ofthe consumer. in this healthcare reform, where does the consumer fit into the picture? he will be followed by david orentlicher who is going to give us an overview of the reform legislation as it stands and as it may be moving along even as we sit here talking. that will be followed by chris sagers who will talk about one of the more direct antitrust issues namely the mccarran-ferguson act which helps to structure the relationship between the insurance industry and the antitrust laws. then we'll turn to tim greaney. tim will focus in more on competi­ tion implications over and above the mccarran-ferguson act. at that point in time we will have some discussion among the members of the panel and time permitting then we'll invite questions from the audience. professor richman: thanks bert and thank you dean roberts 238 indiana health law review [vol. 7:225 and thank you to indiana university. you can tell that i am from one of the right coast here. it's a great pleasure to be here. so it's my job i guess it's really the job of all the speakers -to sumniarize the thoughts of a particular segment of the discussion that the aai organized this morning. the segment of discussion that i am summarizing focused on the question of how healthcare reform and healthcare reform efforts -and par­ ticularly competition law in healthcare reform should be approached from the perspective of consumers? the way that we first have to approach this problem is to ask, well, who exactly are the consumers? and as we start thinking about consumers, what emerges is a multi-headed, multi-conflicted, multi-incentivized entity that suffers from a great deal of confusion. one might think we are talking about the consumer who is a potential purchaser of health insurance, but who currently is uninsured either because they cannot purchase health insurance themselves, because it's so expen­ sive, or because they are working for a small business who itself cannot afford health insurance. alternatively, we might be referring to the consumer who really be­ came notorious and very popular about ten years ago, the consumer who has purchased health insurance, and is now a subscriber to an hmo, but who complains about waits to see doctors, excessive monitoring by insur­ ance bureaucrats, and the mean people on the telephone who deny routine coverage. are we talking about the consumer that cannot afford health insurance now or are we talking about the consumer who didn't like the inexpensive insurance they had before? now, of course, this person is the same person and having low-quality insurance but being able to purchase it is the flip side of the same coin as not being able to afford it now. but we don't think of these two consumers as the same person. we think of these two consumers as expressing legiti­ mate consumer-oriented concerns without any hint of irony, without a rec­ ognition that in fact the better health insurance gets the more expensive it's going to be. the nicer they are on the telephone the more comprehensive the benefits are, the more expensive the premiums are and fewer of you will be able to afford it. that fairly obvious observation needs to be (but so far has not been) 2010] competition policy in health care 239 part of the healthcare reform discussion, and the irony should not be lost on us. when we think about consumer interests, we are necessarily thinking about market trade-offs. so within that lens of consumer trade-offs, and the realistic trade-offs that arise in the marketplace in the provision of any good in a competitive marketplace, we want to think about consumers from three perspectives: the consumer i was talking about a moment ago, the consumer as a purchaser of insurance; the consumer as the patient; and the consumer as the voter. how do we think about all three of these individuals? and how do we think about healthcare reform issues from their perspectives? how can reform advance the interests of these three consumers? since we all identi­ fy with consumers, we think that if we pursue consumer interests, we will not only be promoting competition but we also will be pursuing good poli­ cy. we think that if we somehow get the consumer what the consumer wants, we will achieve socially desirable outcomes. how do we think about ways to enact reform that would advance the interests of the consumer, because after all, all of us consider ourselves as consumers, all of us identify with consumers, we might identify, well, the consumer that we think is less confusing than the one i just described, but we think that if we pursue consumer interests, we will not only be pursuing competition but we also be pursuing good policy, will have social desirable outcomes, if somehow or another we get the consumer what the consumer wants. let's begin with the consumer as health insurance purchaser. what in­ terests are there when we think about the consumer as a person of health insurance? well, certainly we want the consumer to have a variety of choic­ es in the marketplace for health insurance. we think that competition is a good thing, and if the purchasers of insurance have more choices then pro­ viders of health insurance have to compete with each other, and more com­ petition ceteris paribus is a good thing. accordingly, much of the discussion on capitol hill has been really focused on this issue: how do we make sure the purchaser of health insurance has more choices? there are a couple of qualifications to that though. one is, what hap­ pens if you have a highly-concentrated provider market? that is, you have doctors and hospitals that dictate their prices because there are not hospitals or alternative providers down the road that offer competitive alternatives. actually there is a hospital down the road that used to be able to compete, but those two hospitals have since merged. and there are lots of doctors in town but they all talk with each other and they all come up with price agreements and thus all set the same price. lack of competition among pro240 indiana health law review [vol. 7:225 vider.s is a very significant problem. so what happens if you have essentially a monopolized provider mar­ ket? is it then good to have lots of small insurers or do you actually perhaps want one big insurer that could really negotiate price discount from the pro­ viders? the answer is, we don't know. we just don't know what is better. in fact, i think a better way to characterize the literature of economic models and very limited empirical evidence is that it might be better to have a bila­ teral monopoly than to have an upstream monopoly of providers and a competitive insurance market downstream, but we don't know . .so is competition among the health insurers better, ceteris paribus, even without doing anything about the lack of competition among provid­ ers? we don't know the answer to that. another thing to consider is that these are incredibly complicated. in­ surance products. when you buy insurance you are really signing a very complicated and detailed contract. those of you in the world of law know that the market for insurance is really a market for contracts. and markets for contracts usually produce enormous complexity, specificity, terms that are difficult to read, and terms that people don't read. so do you want more competition in that market, ceteris paribus, giv­ en the complexity? the answer to that also is we don't know. there might be very good reasons to have some competition, so the market offers more than one contract, but perhaps too many contracts creates information over­ load and consumers just wouldn't make informed decisions or perhaps won't make· any decisions at all. and if we want useful competition, we need to empower consumers who purchase health insurance to make in­ formed decisions. we need to make the options available to them reasona­ ble, understandable, and comparable to each other. but we're a long way from that. when we think about creating some kind of vibrant market for health insurance, these are things we have to think about. we have to think about the consumer that we have. what about the consumer as patient? you would think the consumer as patient would, like a consumer of cars (or like any kind of consumer), want the best mix of price and quality. when we purchase cars, the quality generally increases with price. generally,. not always,. but generally quality correlates with price, and all of us decide where. along this price quality continuum we want to be. we have 2010] competition poucy in heal til care 241 a certain amount of money, we want to get good quality, we decide what to do, but we make these trade-offs, these price quality trade-otis when we purchase things. you would think that the consumer as patient would make those same decisions -they want good healthcare at a low cost. well, as a preliminary observation, the best price quality combination in america has generally been with vertically integrated delivery systems like kaiser and ·mayo, where the insurer and the provider are either the same entity or are contrac­ tually intimately integrated with each other. we have to figure out why this is a million dollar question or a $2 trillion question -why is it that the best delivery system out there is in .such short supply? why can't we replicate kaiser and mayo, which are re­ nowned for providing excellent quality care at below average prices, and let them proliferate in all of america's healthcare markets? ·why don't market forces yield a deserving winner, like they do for most other products and services markets? · in a market economy that prides itself on competition, it is unaccepta­ ble that the market's superior options are largely denied to the consumer as patient. thus, we have to think about how we can significantly reorganize the delivery system -much more so than the insurance system -to figure out how we can make those choices available to the consumer as patient. what are the reasons market forces are failing so miserably in this market? perhaps we should ask the very preliminary question, what do consumers-as-patients choose? if you listen to the political rhetoric, you are told that consumers insist on the right to choose their own doctor; they in­ sist they have a right to certain healthcare services; and they :further claim they have a right to exert their freedom· of choice. they accordingly de­ mand these freedoms and services from their insurance companies. one priority you do not routinely hear from patients is the importance of economizing, of trying to save money on healthcare. and there is a rea­ son for that. most patients, people who have health insurance, do not know how much they are paying for health insurance. their health premiums are being taken out of their paycheck by their employer, because their employer pays for health insurance and the employee, the employee-as-consumer, doesn't know how much that is. in fact, if you actually ask someone who is making $40,000 a year and say, do you want to spend what amounts to a quarter of your total income on health insurance, clearly most will prefer to economize?· but they are unaware that $10,000 of their annual income is going towards their health 242 indiana heal til law review [vol. 7:225 benefits. so instead you have patients who do not know how much they are paying, and instead only make choices based on quality to the degree they can observe quality. and we have consumers-as-patients saying, i demand to choose my own doctor. i demand to get whatever services i want. i am entitled to these and there is no cost-benefit, there is no cost-quality tradeoff being made. so the decisions that are being presented to the consumers-as-patients are quite dysfunctional. perhaps it shouldn't be surprising that we and we do not have an effective marketplace for competition that would encourage consumers-as-patients to force competition on the provider market. what about consumers-as-voters? consumers as voters are exception­ ally good consumers. they are very loud. they make their voices known. healthcare is a very emotional, very sensitive topic. it mobilizes a lot of political activity. consumers as voters are very, very good consumers. the only thing is they don't really think about that cost-quality tra­ deoff. for example, about in the current healthcare debate has been over­ whelmingly demanded by consumers? perhaps there are two kinds of consumers: those to the right and those to the left. in political debate!?, when ·consumers act as voters, we see a bifurcated market. the country un­ fortunately is very much divided in half and the consumers as voters reflect that. what do consumers on the right say? consumers on the right say, we don't want government in our healthcare at all. of course, that neglects the role ofmedicare, it neglects the federal role of investing in research, it neg­ lects the role of governmental quality assurance, providing courts to resolve disputes, governments providing training for medical residents, military medicine, and many other public health services. the government is heavily involved with lots of things that consumers to the right like and want to keep. what do consumers on the left say? consumers on the left also happen to like medicare. they like the fact that medicare is so comprehensive, and they like the fact that medicare does not manage their consumption at all medicare lets them take what they want, and co-payments are relatively affordable. consumers on the left say, this is great! government organized, government paid-for insurance is perfect. this is what we want, we should expand it. and in fact, one of the compromise proposals is to expand medi­ care to individuals between 55 and 65. but ofcourse, medicare is going bankrupt. we. can't afford medicare and the reason the overhead costs are so low is because it's unmanaged. 2010] competition poucy in heal1h care 243 that means medicare invites over-consumption. is vulnerable to fraud, and does not seek opportunities to economize. even though the consumer loves it, do the consumers realize how expensive it is? one economist in our dis~ cussions said, if you were offered medicare as an insurance option, you would never take it, because it doesn't direct you to make the right deci­ sions. it's overwhelmingly expensive. we don't know this because really our grandchildren are going to be paying for us. the fact there medicare exhibits low overhead probably suggests it should have a higher overhead. tell that to the consumer as the voter. med­ icare is often the third rail or the fourth rail, since social security is. the third railof politics, and the consumer-as-voter approaches this as a rights question, not as a question involving limited resources·in which the current situation is driving the country bankrupt. so for the consumer-as-insurance purchaser, we have to make sure the market works so that consumer is incentivized to make responsible deci­ sions and encourages insurers to provide products that consumers demand. currently it's not that way. the consumer-as-patient currently isn't afforded the options that a market economy should provide. instead, the consumer­ as-patient is not exposed to the costs of his or her decisions and often also cannot observe the quality of his or her decisions and thus many consum­ er-as-patient decisions are misguided and exacerbate the system's current problems. and the consumer-as-voter is speaking out of ideology and is not speaking out of commonsense practicality. so if we want consumers in­ volved on any of these levels, we cannot heed consumers that are inconsis;. tent, uninformed, or rash. we instead need consumers who think comprehensively, who recognize that, for example, typical voters make de­ mands that hurt typical insurance purchasers, or who recognize that the needs of insurance purchasers are in tension with the demands of patients. a consumer who thinks comprehensively is more likely to act responsibly, instead of driving toward choices that push costs on other people. mr. foer: thank you, barak. that's something i always wanted to say. thank you, barak! now david orentlicher is going to tell us how the other barack and his friends on the hill are going to fix things. professor orentlicher: well, thank you! i guess the inter­ esting thing after hearing all the series of concerns that barak has laid out nicely is how few of them are being addressed in the healthcare reform pro­ posals. that's really the sad thing about it all. i'm all for healthcare reform, but the way i put it, rather than trying to fix a flawed system--you've heard of the many flaws it has--what we're really trying to do is put more people 244 indiana health law review [vol. 7:225 into the flawed system and hope that down the road that will create enough voter support for fixing the flawed system. but when you look through the thousands of pages, there is discussion but in terms of real impact on the flaws, there really is not much there. so what are we doing? the goal is to· cover the uninsured. we've got 15% of our population, 47 million--it's probably higher because the data will have­ n't caught up with the recession--in the range of 50 million uninsured. so how do we get there? some of us have wanted some sort of single system where everybody gets health care, whether it's a medicare-for-all or getting back to some of the models out there. barak identified some good ones, but maybe the best model out there is the va healthcare system. if you want a low-cost high-quality system-it turns out the british system brought over the u.s. in the form of the va healthcare system, is that kind of system. if you are a qualified veteran--not all veterans are eli­ gible--but veterans go to hospitals operated by the u.s. government, doctors employed by the u.s. government and you get high-quality low-cost care. it's not very convenient care--you might have to travel a ways to get your care--but you'll get good care. but it has never been on the table to have va for everybody or medi­ care for everybody. but how else do we get everybody into the health care system? what's another important model out there? it's the ger­ man/dutch/massachusetts model. we make sure everybody is insured by requiring them to buy insurance. and this· is kind of an american approach. we believe in individual responsibility. if we think back to the patient as voter, what we find is that patients as voters don't very much like government benefits that are viewed as handouts. in the us, you've got to earn your benefits. you've got to be a "deserving" recipient. i put this in quotes--please don't think that this is my view--i'm caricaturing and not everybody takes this view, but it's a strong sentiment in america that you should be a deserving of your government benefits. so we have good healthcare for seniors who have earned it be­ cause they've worked hard all their lives and they've gotten to a point where their age is overtaking them and they are sick not because they've acted irresponsibly but because that's the nature of aging. they don't have the money to buy .insurance because they are retired, so we cover them. we cover children because how can you hold children responsible for not hav.;. ing healthcare, that's not reasonable. but if you're an able-bodied adult, why don't you out there working? if 2010] competition poucy in health care 245 we give you healthcare insurance, you probably won't work because why would you if you get everything for free. so it's an american approach, and so we're going to require you to buy insurance. if you can afford it, you ought to get it on your own. so there is an in­ dividual mandate to purchase insurance in the house and· senate bills, with exemptions for the lower-income persons and there will be subsidies for other people. you are working, but may be you are employed in a job that only pays $40,000 or 50,000. can we really ask you to spend 25% of your income on healthcare insurance? that's not realistic. so there will be subsi­ dies that phase out at $88,000 income; that's what's on the table now. . well, why would you buy an insurance if you don't have it now--there must be reasons why you haven't bought it--and if it's still very costly, why would you buy it? well, we'll penalize you if you don't. there are fines that will amount to in the senate bill about $750 per person and in the house bill, it's a percentage of income. but let's say, you are a single person earn­ ing $60,000. under the house bill, you would have to pay, about $1000 in penalty. so if you are earning $60,000 and you have to go out and buy insur­ ance and it might cost you $6,000 or $7,000, and the penalty is only a $1000, you still may not buy it. so this is one reason why even with the mandate, we are not going to get to universal health care coverage. there's another way to help cover the uninsured. who else has some responsibility under the house and senate bills? employers. even though employer-based insurance has problems-as barak says, we don't really know how much we're spending on health care coverage. indiana universi­ ty is kind enough to tell its employees. if we look at our pay stub, it tells us how much of our salary iu is spending. but we never get the money. so we don't feel like it's our money. we feel like it's their money that they are u,sing for us rather than taking it out of our paycheck. but they really are taking it from our pay. both the house and senate have kind of employer mandates. under the house bill, employers either provide ·insurance or they will pay· an 8% payroll tax. so whatever your payroll, multiplied by 8%, which is a pretty good incentive to provide insurance. the senate doesn't say you have to provide insurance, but if you have at least one employee who gets a government subsidy to buy insurance-­ because you are not providing coverage, so the government has to subsid­ ize--then we are going to charge you $750 an employee. that's the incentive to provide health care insurance. but the house has a stronger incentive 246 llidmna~thlawrevffiw [vol. 7:225 than the senate. ·· ·what else?· insurers. if people have to purchase insurance, insurers have no reason to do actuarial screening and decide whether to offer cover­ age~ if you don't have to buy insurance and if insurers had to provide you coverage, you'd wait until you are sick. why buy coverage when you are healthy? many people would say, "i'll wait till i am sick." but that's not fair to insurers. if you have to buy insurance, then we can say to insurers, you have to take all comers. you can't reject somebody, because they have preexisting medical problem. say they've got diabetes or heart disease. you can't refuse to cover them, you can't charge them a higher premium. that's an important protection for the people who don't have an em­ ployer who provides insurance. their inability to buy coverage, because of preexisting condition, this will take care of that that's a very important part of the health care legislation. in addition, there will be no more lifetime caps on coverage. most people have $1 million, $3 million, $5 million dol­ lar cap lifetime. those caps will be eliminated. well, where will you get insurance if you now have this burden to buy it? if you don't work at iu or lilly, and get your insurance, you have to go and buy it. where will you buy it? the government will set up insurance exchanges, either nationwide under the house bill or state-based under the senate bill, where insurance companies will have to meet certain qualifica­ tions to sell their plans. massachusetts has set up a similar kind of program under its mandate to buy insurance. so you can go and shop, and the gov­ ernment has screened and made sure these are plans that provide good qual­ ity coverage. so there will be a marketplace that hopefully will generate competition, and you'll buy your insurance there. what about the very poor people? there are limits on how much we can subsidize health care premiums. medicaid will be expanded to cover people. in the senate bill, medicaid will oover people up to 133% of the federal poverty level. what does that mean? for a single person, it is proba­ bly in the range of $13,000 or $14,000 income. anybody below that level will be under medicaid. if you are a family of four, and you earn less than $30,000, you would qualify for medicaid. not everybody will be insured-we'll get into the 93, 94, 95% range according to projections. this, then, is the expanding access part. how we are going to pay for this expanded access? it's not going to be free.' although, it could be in some ways, because we do spend far more than every other country. this is one of the paradoxes. we spend more and get less. all these other countries reach all of their population and spend 2010] competition poucy in health care 247 less -many of them spend half or less of what we spend. so in some ways we have. the money to cover more people. but there are a lot of inefficiencies that we are not addressing-and that's the problem we are not addressing. why do we have such high cost? why aren't there more kaisers? why aren't there v a-kind of systems all over the country? well, we are not addressing that, we are not trying to replicate the low-cost high-quality systems. so it's going to cost us more money to expand access. now remember president obama said, he is not going to tax anybody who earns less than $250,000. so if you are not going to tax the average american, where are you going to get your money? the house wants to tax wealthy americans and that's fair, they probably can afford it. so there is going to. be an income tax surcharge on high-income individuals {ofcourse, nobody is high-income; we are all middle-income). high-income is defined as a single person earning more than half a million or a family more than a million. high earners will have to pay a higher income tax on their incomes above the half-million or million dollar levels-:a 5.4% additional tax. in addition, there'll be a sales tax on medical devices under the house bill. raising the income tax is controversial, so the senate is going to just raise the medicare tax a little bit for high-income persons, and then the se­ nate is going to tax high-cost healthcare plans. we've got a tax exemption for healthcare insurance that encourages people to purchase too much insur­ ance. and so, if you have a "cadillac" plan {a gold-plated plan), you'll pay a tax, and that will discourage people from having these excessive, gold­ plated plans. the unions don't like the tax because they've negotiated some of these gold-plated plans for their workers--that's why the ax is controver­ sial. under the senate bill, there'll be a tax on elective cosmetic surgery. there also will be new fees on drug companies, device companies and in­ surers, because nobody likes drug companies, device companies and insur­ ers. these businesses are easy to tax--unless their lobbyists object .wq much. all of this is going to generate a fair amount of money, but. not enough. so where else can we get money? we can cut medicare spending by $400 billion over ten years. how do we do that? well, we reduce reim­ bursement rates to health-care providers; doctors get less money, hospitals get less money. let's remember, congress periodically says they are going to do that, but every time, they suspend the reimbursement cuts. now and then, they have reduced reimbursement rates, but will they really sustain $400 billion in cuts? that's a good question. 248 indiana health law review [vol. 7:225 medicare advantage is the private medicare option. you can go into the traditional medicare plan in which the government pays the bills, or you can subscribe to a private health plan, and medicare will pay your premium. 20% of medicare recipients do that, and it actually costs more than tradi­ tional medicare. so it's time to cut that back, and that's part of the proposal. in sum, there are several big concerns. you are asking people who earn $60,000 to spend $6600 toward insurance. can they do that? that's after subsidies. so a lot people aren't going to be covered. will the subsidies keep up over time. will congress really year-after-year vote appropriations for lower-income people for their subsidies? will congress stick to the medicare plan cuts? will all of this survive the next few years? it's great to expand access, but that's not going to happen until 2013 or 2014. will congress maintain this legislation until it kicks in three or four years from now. if we continue to have trillion dollar budget deficits, and we have wars to fund, who knows? and then what about the strategy of expanding access now, deal with the costs later?, it's much easier to expand access--the voters love that--but try to ask them to cut costs. we saw the hmo backlash in the 1990's. hmo's were really good at cutting costs without sacrificing quality. but people didn't like the limits on coverage, even though they were good lim­ its. even though they weren't being harmed by the limits, they didn't like them. and so, we are not going to try cutting costs right now. we'll expand access and deal with costs later. but that doesn't always work, because it tends to unravel over time and become unaffordable. that was what hap­ pened when oregon expanded access to healthcare. they tried it, and it worked for a few years until state ran out of money. it worked because they had a boom in the economy. when the economy turned, the state couldn't afford to pay for the expanded access and their level of uninsureds is as high as it was when they started. so who knows. but as president obama said, sticking with the status quo is even worse. mr. foer: thank you, david. question: how many people out there think they could explain what the mccarran-ferguson act is? just raise your hand okay, it looks like chris has his hands full. go ahead and explain. professor sagers: i will do my best and i will actually try to keep it brief. i'm very pleased to say first of all that i have kaiser perma­ nente insurance and it rocks. so yahoo! kaiser! after those two very broad presentations i am going to give a very, 2010] competition poucy in heal til care 249 very narrow one. it's one that's directly relevant to the topic that we pro­ posed today and the topic that we talked about during what was really a great session this morning. that topic was: what should be the role of anti­ trust in reforming or improving our healthcare system? the reason that mccarran-ferguson repeal is relevant is that the busi­ ness of insurance since 1945 has been to a certain extent exempt from anti­ trust. to make a long story short, antitrust is the federal law in the united states that requires that businesses compete with each other and not collude or try to avoid the effects of competition. well, we have had a federal statutethe mccarran-ferguson act-­ for about 60 years that has said antitrust doesn't apply to insurance. instead, insurance companies are subject to regulation by the state governments. and to some extent the state governments do enforce competition values, although i think most observers believe they recognize them in name only and don't really enforce them. by-and-large there doesn't seem to be much doubt that in health insur­ ance we don't have a competitive marketplace at all. health insurance mar­ kets are local, and most local markets throughout the united states reflect some degree of concentration, quite a lot of them severely so. concentra­ tion in this context means that there aren't very many sellers of insurance in a given market. when there aren't very many sellers you likely don't have much competition, which means you don't have much effort to lower prices or reduce costs. well, efforts to repeal the mccarran-ferguson act go back now about 20 years, and once again there is a repeal effort, which has been seen all along as part of healthcare reform. the bills that have been pending this year to repeal the mccarran-ferguson would apply only to health insurers and to medical malpractice insurers. i guess that superficially makes. a cer­ tain amount of sense, because those are the two insurance markets most re­ levant to the cost ofhealthcare, or so one might think. apparently for reasons of political expediency more than anything else, this year's bills would repeal the mccarran-ferguson immunity only as to certain kinds of conduct. in other words, the bills wouldn't say the mccarran-ferguson act is hereby repealed as to the business of health and medical malpractice insurance. instead, it says the immunity is repealed, and i am quoting here, with respect to ''price fixing, bid rigging and market allocation". those are antitrust terms of art. to make them simple, price fixing is conduct in which two competitors get together and say, okay, we 250 indiana health law review [vol. 7:225 won't sell our product for less than so and so. market allocation is the really fairly similar sort of arrangement in which competitors say, okay, you get toledo; i'll take cleveland. and as for bid riggingi don't even know what they were thinking with bid rigging. it's really just a variety of price fixing. anyway, the state of play right now is that the these were introduced to repeal mccarran were introduced as freestanding bills, but all along it was clear that there would be an effort to make them part of the overall health reform effort. indeed, the house mccarran-ferguson repealer was incorporated by speaker pelosi by manager's amendment in the house healthcare bill, which passed the house in early november. the senate version of that same bill hasn't yet been included in the senate health bill. however, senator leahy, who sponsored, intends to add it by floor amendment. but it's really much less likely that repeal will be included in the final senate bill. we've heard a lot about the three moderates in the senate who have opposed the leadership bill. one of them is senator nelson of ne­ braska. he is formerly a state insurance commissioner and an insurance executive and he opposes mccarran repeal, and it seems likely that he will manage to keep it out of the ultimate bill. whatever. hope mccarran repeal ultimately has lies only with the conferees, who might try to include it in a conference bill. so that's the state of play. but the real question that i was asked as part of this conference was, assuming some version of mccarran repeal is adopted, what will be its consequences? in a sense, my answer must beg a $64 question. i think barak richman correctly identified it already: conceding that health insurance is not competitive, would it actually make that much dif­ ference merely to expose it to competition? i don't think anybody can really say how much impact competition would have. there is an argument that it wouldn't have that much impact, mainly because insurers can enter a new marketplace only if they can estab­ lish relationships with the existing network of providers in that area, and that's believed to be very difficult at least under current circumstances. so even if the risk of antitrust liability were made much more mea­ ningful, in health insurance it would at least take a while for robust compe­ tition to break out. now, i personally believe that mccarran simply must be repealed, it has no justification and it does have bad consequences, but for 2010] competition policy ln health care 251 what it's worth even i think that it would be only a necessary, and not a suf­ ficient, solution. even aside from that uncertainty, predicting the consequences neces­ sarily raises two other questions. first, these bills join medical malpractice and health insurance in the same policy instrument. while that makes a certain superficial sense, the two markets are really quite different. medical malpractice insurance is a so-called "property-casualty" product, which means that it insures people against the risk of liability to third parties. so if a doctor hurt somebody negligently, medical malpractice insurance will indemnify the doctor. health insurance is not property-casualty insurance. it's quite differ­ ent. part of our discussion earlier today concerned the fact that health insur­ ance arguably isn't insurance at all, or at least most health insurance is pretty different. the problem in genuine property-casualty markets is that it's very hard to anticipate how much a company must charge in premiums today to en­ sure solvency when significant losses come down the road. indeed, all ob­ servers of these markets acknowledge that there is a problem in property­ casualty markets, which goes by the name "insurance cycle" or "underwrit­ ing cycle". periodically pretty much all the insurers in the market will real­ ize, boy, our premiums are kind of too low right now to ensure our long­ term solvency, so we've got to really, really jack up our rates to make sure we don't go under. that's a recurrent problem. the only point for my purpose is that the existence and the persistent lack of any persuasive explanation for the insurance cycle is a problem in medical malpractice insurance. it's arguably relevant to whether antitrust immunity is needed. personally, i don't think it's a very good argument, but it's one that's being made. the other problem, which is a significant one and is frankly much too thorny to really dig into in this setting, is that the mccarran repeal bills would not repeal the immunity entirely, even as to health and medical mal­ practice insurers. as i said, the repeal would be limited to specified conduct like price-fixing. so health insurers and medical malpractice insurers would still be immune from antitrust for conduct other than price-fixing or market alloca­ tion, so long as that conduct is also within the remaining vestiges of the mccarran-ferguson immunity. now that long sentence, i think, gives some flavor of just how complicated this· problem really is. to know whether conduct would be immune following this repeal, one would first have to ask 252 indiana health law review [vol. 7:225 whether the conduct price-fixing, bid-rigging or market allocation. if not then the question is whether it would be immune under the existing law of mccarran immunity? that is, is it the "business of insurance," and is it re­ gulated by the states? in other words, it's a really complicated mess. and even within that complicated mess, to make matters worse, the case-law.that exists under the mccarran-ferguson act was already messy. nobody really knows exactly what, for example, is included within the statutory ·term the "business of insurance". does it cover price-fixing, for example? sometimes yes, some­ times no. anyway, to sum up a very complicated problem, even if the repeal bills were adopted they likely will have some sort of limitation to specified conduct like price fixing. the repeal will not apply to some conduct that might be bad. so even if the repeal goes through, insurers might still be able to be to do those bad things. the flip-side of that same coin is, some types of conduct that the re­ peal actually would apply to are in many cases already illegal the mccar­ ran-ferguson act doesn't apply to everything it shields insurers from antitrust only when they engage in conduct that is "the business of insur­ ance" and it is regulated by state law. so there is sort of a double problem in the repeal that we are likely to get: it won't expose some genuinely bad conduct to antitrust liability. on the other hand, it will make antitrust liabili­ ty available to some conduct that's already illegal and therefore already nominally discouraged by the law. still, having said all that, i just want to say a couple of things about why even a limited mccarran repeal might still be a good thing. first, there may be important long-term effects. in the future, if mar­ kets become more competitive, then some types of conduct might start to arise that will be open to antitrust liability under this repealer. second, there is a certain psychological value to repealing mccarran­ ferguson. among other things, when congress says that specified conduct is now illegal, it is a pretty strong message to the justice department or the federal trade commission to actually do something. and finally, a very technical point. there is also language in the house health bill that would correct limitations on the power of the federal trade commission,.which i think could be very valuable. specifically, the federal trade commissionwould be empowered to investigate the insur­ ance industry, including but not limited to antitrust enforcement. but also 2010] competition policy in health care 253 beyond the antitrustenforcement. that is work the federal trade commis­ sion hasn't been allowed to do for about the last 30 years, and it could be extremely valuable. mr. foer: okay, thank you chris. we are going to change signals a bit at the line of scrimmage here. david balto's airplane is leaving a little bit late so that gives us an opportunity to insert him into the wide end posi­ tion and send him downfield with if you take too much time the plane is going to leave. so speak to us. mr. bal to: thanks, bert. this is really a heady end time for all of us antitrust nerds. we are like the kind of people who are at the dinner par­ ty, just waiting for somebody to ask us aboui competition or consumer pro­ tection and n<!)body ever does. but we sit there quietly and politely. · this is a fabulous time in washington for antitrust nerds, because every day we hear congressmen talk about the key to healthcare reform is competition. we couldn't be happier. i mean it's sort of like being an indi­ ana ice fan. ate there any indiana ice fans here? so you don't even know about . the ininor league hockey team. and all of a sudden they win the ushl championship. the problem is that we really have what is the most ragtag structure. first of all, let's get the basics down. competition and consumer protection, enforcement is important, because we want markets to work effectively. and there are basically no one has so far has disagreed with me on this diverse panel but there are three things you need for markets to work. you need choices because you want to have alternatives to play people off against each other. you need transparency; you need to know what you are buying and what the terms and conditions are. and then espe­ cially ·.when we are dealing with intermediary markets, we want to make sure we've got honest brokers. we want to make sure there are not conflicts of interest, that people really do represent your interests. and, by any meas­ ure, and i am just going to stick with health insurance, this market is bro­ ken. in terms of choice, all studies seem to point to the fact that most mar­ kets are extraordinarily concentrated with a large number of states being dominated by a single insurance company. in terms of transparency, good luck! read.your insurance policy, have your employer who purchases the insurance read your insurance policy. these things are inordinately com­ plex. consumers really don't know what they are getting. there is really a lack of transparency. 254 indiana health law review [vol. 7:225 and finally in terms of conflicts of interests, insurance companies don't necessarily act in the interests of consumers, and brokers who are hired don't necessarily act in the interests of the employers who hire them. what is the result? well, president obama, in a seminal statement to the american antitrust institute, when he had to identify one market that was not working competitively, it was the health insurance market. and he pointed the finger at the antitrust division of the department of justice, which in the past eight years has allowed a tsunami of mergers. over 400 mergers in the past eight years, which has led to this tremendous degree of concentration. of those 400 mergers, how many did the department say no to? they just asked in a couple for a minor restructuring. so they basically let mer­ gers proceed at will. and the story isn't much better in terms of going after anticompetitive conduct against health insurers. chris has told you about an antitrust exemption. that's where congress says, don't worry, you live in an enforcement-free zone, collude at will, and stuff like that. well, there is another way to grant exemptions to industries and that's by having lazy or misguided antitrust enforcers. and basically, over the last eight years, the antitrust enforcers brought zero actions against anticompeti­ tive conduct by health insurers, zero actions against fraudulent or deceptive conduct by health insurers. zero. the ftc, for example, spends all of its health consumer protection re­ sources going after those fraudulent advertisers who tell you that if you take this pill, you'll lose 20 pounds over the next week. that's where they spend their time, protecting those people who are easily duped. so what's the result of this total lack of enforcement? in the past eight years, the number of uninsured have increased from about 38 million to well over 47 million. the profits of the major for-profit insurance; compa­ nies have skyrocketed from about $3 billion a year to over $13 billion a year and premiums have similarly skyrocketed. this is an industry that is out of control by any measure. hopefully the attention that has been given to the fraudulent and egre­ gious conduct by health insurers will somehow filter down. the distance between the capitol, the senate, the house and the federal trade commis­ sion is six blocks. it's only another three blocks to the antitrust division of the department of justice. and i think they might have tvs there. they might have watched the congressional hearings that are going on. hopeful­ ly that will filter down to these antitrust and consumer protection enforcers. what would we hope to see from a reinvigorated antitrust and con2010] competition poucy in health care 255 sumer protection enforcement from the antitrust division at the depart­ ment of justice? first they have to learn that famous two letter word that nancy reagan tried to teach us. 'no'. the next big health insurance merger that comes along, the antitrust division should just say no. and in terms of mergers that have occurred in the past that may be anticompetitive, it's time to see what happened and see whether or not consumers have really benefited, and by the way you do get two or three bites at the apple when you are an antitrust enforcer. you can go and correct your mistakes. it's like being catholic. so they can go back and try to rescind consummated health insurance mergers. second, they've got to realize that the consumer protection laws ac­ tually do apply the health insurance industry. now there is a little thing here. other people on the panel may say that the state insurance commis­ sioners are responsible for consumer protection enforcement and indeed states have these statutes. the problem is, states don't have resources and we did a study that found that basically over one third of all states have never brought a single consumer protection action against fraudulent or de­ ceptive activity by health insurance companies and something like 95% of the actions were brought by just four states. if you want to have health insurance protection move to new york, move to california. otherwise, good luck. in many states, the insurance commissioner has 50 million other things to do and doesn't have time to make sure that those laws are properly enforced, so hopefully the ftc will step into this gap and go and start having meaningful enforcement against deceptive actions -not only against those people who sell you those pills for which you'll lose 20 pounds by just taking them but also against egre­ gious conduct by health insurers. third, the ftc has the secret weapon. it's called section 5 of the ftc act. the simple shennan. act prohibits relatively straightforward but li­ mited types of conduct. section 5 of the ftc act prohibits things that are unfair trade practices. the ftc should learn to use that statute to go after some of these egregious and deceptive practices. hopefully, that six-block or nine-block distance between congress and the two enforcement agencies isn't too big of a gap to bridge and those agencies will pick up with an activist enforcement agenda against health insurance companies after a health insurance reform is passed. mr. foer: okay, thank you david, now you can catch your flight. this brings tim greaney to bat. 256 indiana health law review [vol. 7:225 professor greaney: before david leaves, let me agree with him on one important thing: antitrust enforcement has gone straight down­ hill since i left the justice department and since he left the ftc,( and since bert left the ftc as well). so he is definitely right on that score. okay, let me go off message for a minute because i think some of the introductory remarks about the health reform sounded pretty pessimistic. i certainly have a lot of criticisms and have disagreements with a lot of what's going on, but let me just throw out a few reminders about why we're here. you've heard the numbers. our health care cost is two times that of the oecd countries; the only country in the developed world without full insurance for its citizens; ranked 37th by the world health organization, which uses various measures, but you really dissect quality, one sees we are very low on many important quality measures. sure, we're good on some high-end cancer treatments but we are way down the list on preventa­ ble illnesses, newborn care and all sorts of routine healthcare quality me­ tries .. so let's remember there is a lot to be done. about financing compre­ hensive reform, first of all remember, the cbo projection concludes that reform will reduce the deficit over ten years. i repeat, reduce the deficit. now there are taxes proposed to pay for reform the house bill relies on a more progressive tax mechanism, a policy i would have thought would have some popular and common sense appeal. if congress repealed the bush tax cuts for the top 1%, top 1% of the country, that would pay for something like three-quarters of the ten year cost of the obama healthcare plan. and if you remove all of the bush tax cuts you'd be paying for two­ and-a-half times the cost of the healthcare legislation,. so i ;think, flawed as reform is in some respects, doing nothing is·not an. option and i think the unimpeached projections about future costs sug­ gest we are in real trouble if we don't move forward. i think there are very important potential cost-saving provisions in the legislation, reforms that cbo can't measure because of uncertainties about the form these new programs will take and how they work. although cbo chooses not to measure some of them, they constitute a very important redi­ rection ofmedicare payment policies that hold out the hope of really chang­ ing the way healthcare is delivered and on top of that, remember, there is massive investment going on in infrastructure through this bill and the stimulus bill. my. state missouri is getting $2 billion towards improving information technology and related 2010] competition poucy in healtii care 257 improvements. there is a lot of money going into education, training alternative care providers, doing a lot of the things we haven't been doing for the last 20 years. a lot of that is hard to measme: how it will be implemented, how much it will save? but there are real savings there. so although some of the pessimism out there is justified, i think these reforms are absolutely neces­ sary. so my assigned task was to talk about competition as it affects provid­ ers, hospitals, doctors and device manufacturers, and relate that to antitrust. the first message i want deliver is that competition does matter. it matters with regard to basic the structure of this reform proposal, and it does matter in the marketplace, as we do have evidence that the competition has lo­ wered cost. studies of hospital mergers have shown that these mergers have raised costs from 540% in the markets in which they occurred. we also have evi­ dence that more competition can promote greater diversity of options, that physician competition can result in lower costs, and that we can have real benefits from competition. one of the reasons competition matters is because when you have markets that are concentrated i.e., you only have a few providers of a health care service in town they tend to raise prices. and we've seen over time, especially in the last ten years, some very dramatic increases in con­ centration, particularly in the hospital market --where my alma-mater the antitrust division of the justice department was, as david suggested, as­ leep at the switch, it's also apparent were also asleep at the switch in other areas, as not a single physician merger has ever been challenged. now there is what may appear to be a paradox when we talk about concentration in health care delivery. you have pockets where there is very · little competition, i.e., acute care hospital markets, and many specialized specialty physician markets; for example, cardiology and orthopedics ser­ vices in many markets are highly concentrated. at the same time, you have remarkable fragmentation. in most mar­ kets, primary care physicians are practicing in solo or very small groups, and health care delivery is fragmented in the sense that there's very little care coordination, which is especially important in treating chronic diseas­ es. so we have the worst of both worlds. we see large pockets of concen­ tration around the country, and at the same time we have fragmentation so 258 indiana health law review [vol. 7:225 patients don't get the kind of care delivery that would promote higher quali­ ty care. as to integration of the kind that barak spoke about, "vertical inte­ gration" in antitrust parlance, linking hospitals, to physicians, to nurses, to alternative care providers, to social workers: that kind of linkage is abso­ lutely essential to making competition work, especially with respect to mak­ ing bundled payments. that is, insurers compensate providers by making payments to a single entity, saying ''you· distribute that money, allocate that payment among your providers, among your hospitals, specialized physi­ cians, ·nurses, social workers, but do it in a way that provides high quality, cost effective care." essentially these entities, which the reform legislation calls accounta­ ble care organizations, will pay people to take histories on care, pay nurses and others to call people to make sure they are taking their meds, etcetera, all things the systems fails to do now. that distribution system is essential to have not only higher quality care, but also cost-effective delivery of care. so the bottom-line message of what we talked about this morning and the writing some of us are doing is that you do have fundamental structural problems in the market that need to be dealt with in order to help competi­ tion succeed. admittedly we encounter a real world problem when it comes to pro­ vider market structures because, to some extent, the horse is out of the bam. some ofthe pockets of local provider monopolies are there to stay. but we can do some things to encourage development of new competition, some­ times specialty hospitals will develop, we can promote new entry by physi­ cians, new physician groups forming and there is a strong case for removing regulatory entry barriers. antitrust law certainly will have a role in the future both in guarding against future concentration, increases of concentration through mergers, and dealing with abuses of monopoly power. . for example, one problem that arises in many markets is that the enti­ ty with market power can exclude others. and frankly, the case law that has developed through the courts has not been favorable to these cases. the op­ timists among us hope that a more vigorous doj antitrust division and ftc might result in better case law developing. as i mentioned before, there are things that i think the legislation is doing that can encourage providers to reorganize markets. these are among the most important-and overlooked--features of the senate bill--changes that will both encourage and subsidize through efficient payments, the de­ velopment of new organizations. such as accountable care organizations 2010] competition policy in health care 259 and medical homes. these innovations are going to take some time to develop but the leg­ islation would establish medicare pilot programs which can be turned very quickly into system-wide programs. so that's an important development to watch. finally, i'll just offer a few thoughts about developments in the com­ petition law world. those of you who follow antitrust probably know that there is an important case in the supreme court right now, the american needle case. aai has written a very important brief in that case, because it is the kind of case that could change antitrust law very dramatically. we don't know which way that will go, but it is important in health care that antitrust law not retreat from recognizing that joint ventures among inde­ pendent competitors should not get a free pass unless there strong pro­ competitive benefits flowing from the venture. continued competition advocacy by doj and ftc, before federal and state health regulatory agencies is important to keep them on the ball and keep them enforcing the law. and, as david said, there are other areas where the government has been very successful, and that has brought many important cases. one of the most notable is in the pharmaceutical area, where the ftc has challenged so-called reverse payments by major pharmaceutical com­ panies. basically, what that involved is the practice of many brand-name, patented drugs, essentially, paying off generic companies to get them to stay out of their market. the numbers are staggering as to how much this is cost to the con­ sumers. i think david mentioned earlier the ftc estimates are that the cost of these payments is $3.5 billion per year-that's how much extra consum­ ers extra are paying for drugs, because the brand name drugs have kept out generic competition. there is an ongoing dispute right now about what antitrust standards should apply to these practices, as several circuit courts have given differ­ ent interpretations. legislation is pending in congress to put in place a clearer (and more stringent) standard. the ftc is to be commended for its leadership in this area. finally, david didn't get a chance to talk about it, but many of his complaints against the insurance industry are at bottom consumer protection issues, and those are topics that both state and federal enforcement efforts should be directed at -just egregious abuses persist out there that can be 260 indiana health law review [vol. 7:225 tackled under insurance, fraud, consumer protection and other laws. . i'll leave it at that and i am sure we have time for questions. mr. foer: yeah, we have and we do and let me ask gayle if she would like to say anything about the reverse payments issues that just came up or anything else. reverse payments is one of the most important devel­ opments in the last 20 years in antitrust. ms. reindl: well, it is. and the federal trade commission, to give them a few little feathers in their cap, actually has been active in this area and has challenged several of these, what the ftc calls "pay for de­ lay' settlements. this is where the patent holder with the brand-name drug, instead of litigating to the end, just pays the generic competitor to stay out of the market for a long period of time. the patent-holder keeps the monopoly, the generic competitor gets some of the monopoly profits and the two drug companies are happy, but consumers end up paying, the ftc estimates, $3.5 billion a year more than they would pay if the generics were made available. so the ftc has brought cases challenging those settlements. the problem is the courts are inconsistent. some of the courts have rejected the ftc's challenge to the settlements. so, legislation being considered in congress would make it clear that this sort of a pay-for-delay or reverse payment settlement breaks the law. mr. london: well, since we are talking about generic drugs in a sense, let me just make the short point that there are success areas for com­ petition even without new legislation. generic drugs are now something like 70% of the prescriptions that are written and actually last year, the total cost of generics even though the percentage -the prescriptions rose, we spent almost 3% less. so i think chris said earlier, we have some questions about competition. i don't really have ,any questions. i'm sure if we had the kind of competition we'd all like here, all through this healthcare system, you'd get the kind of results you're beginning to get in the prescription drug market. i think there is more to come because the business model in prescription drugs is being changed by mail-order, it's being changed by wal-mart and target and some of the gro­ cery chains, who were cutting prices very sharply on some of the older ge­ nerics which are very effective. so i think competition in the drug arena is the proof of what competi­ tion could do in the health area if it really began to work. professor co manor: the beauty about this panel· is that eve2010] competition poucy in health care 261 rybody takes a different view on every topic. and so i don't understand what the audience is making of it. so i want to go on a rather different tack, because of course what we're really concerned with is healthcare much more than health insurance. -and sometimes we confuse the notion of health insurance with the no­ tion of healthcare, and those are really different things, especially since in­ surance in this country isn't really insurance at all. insurance deals with payments for very unlikely events, like your house burning down, or your being involved in an auto accident. but we all know that we are going to need healthcare in the course of the year or most all of us. so except for major medical issues, what we currently call health insurance isn't health insurance at all, it's pre-paid payments for health care, so that our expected payments are made by some third-party rather than ourselves. well, you might say, but my employer pays for it, so i don't have to pay for it; isn't that the same thing? the answer is yes, because we know that from the employer's point of view, it's the total cost of the employee that matters, which includes wages plus benefits, and the most important benefit of course is health insurance. so if the employer doesn't pay health insurance for you, you would re­ ceive higher wages, because that's the amount the employer is willing to pay for your services. so each of us pays for our health insurance in the form of lower cash wages. what's the advantage of having our healthcare paid in this indirect way? well, back in 1945, really is an afterthought during the second world war, the congress made a rather strange decision which we are stuck with. it said that health insurance and other benefits would be deductible for the employer but not taxable for the employee. so the reason why we like this insurance fayade, and it really is a f~ade, is because we're paying for our healthcare with before tax dollars, while we pay for everything else with after-tax dollars. indeed, the largest aberration of the current system is this strange tax subsidy which came to us as an afterthought during the second world war. currently, a large share of the problems we face with health insurance are due to the rather bizarre way that we finance healthcare through the em­ ployment contract. if you think about it, there is no essential reason why healthcare should be financed through the employment contract. but, we do it because of this afterthought of 50-plus years ago, and that's what we should be avoiding rather than the type of reform that we see 262 indiana health law review [vol. 7:225 now. we've seen in recent years increasing numbers of uninsured people. and i thought of that as a plus, because this was the means by which the existing system would go away, it was self-destructing. so what did the obama·plan do? it seeks to prop up the existing system of prepaid health­ care which is called health insurance but which isn't health insurance at all. now, i surely agree with my panel members that it's better than doing nothing. it's certainly better than doing nothing. but we had a chance to make a clear reform effort in the way we finance healthcare, to bring us back in accord with the levels of expenses commensurate with other coun­ tries in the world, and we chose not to do· it, and that i think is the great failure of the current healthcare reform plan. mr. foer: when you refer to bringing us back to expenses com­ mensurate with the rest of the world, bill, i take it you're referring to the expenses that are incorporated into the price of products that we are selling in the international market? professor comanor: no, what i was really talking about is the fact that we spend 15-16% of our gross domestic product on healthcare, while most of the other developed countries spend on the order of 10-11%. that's a big difference. mr. foer: make my point as an additional point then, which i think is that there is a serious implication of that unthinking choice bill is refer­ ring to that puts us in a bad position worldwide. let me turn to joe bauer. professor bauer: thanks bert, and i really want to thank both the iu indianapolis school of law and in particular max huffman for ar­ ranging this conference. it has been terrific. i hope it's been fascinating for you. but it has certainly been fascinating for us here on the panel who have been here since 9:30 a.m. and really had the opportunity to become edu­ cated about a lot of these very, very important issues. i wanted first to talk briefly about something that chris was talking about the mccarran-ferguson act. chris didn't go through the long, exten­ sive, and perhaps not overly interesting history of the mccarran-ferguson act. but, mccarran-ferguson was passed in 1945 in an attempt to restore the balance between state and federal regulation of the insurance industry. it had long been assumed in the united states by the courts and oth­ erwise that insurance was a local enterprise and therefore would be· regu­ lated only by the states. the supreme court decided a case called 2010] competition poucy in health care 263 southeastern underwriters which really upset that understanding, and in almost record time -i think it was less than two months -a bill called the mccarran-ferguson act was passed by both houses of congress and signed by president roosevelt, one of his last acts before his death the fol­ lowing month. and what mccarran-ferguson provides as chris said was not a complete exemption for insurance companies, but an exemption for the so-called business of insurance, and that term, what that really encom­ passes or does not encompass has been the subject of much uncertainty for over half a centt,uy. mccarran-ferguson also says that in order to be subject to that ex­ emption that the activity has to be regulated by the states. probably one of the saddest parts ofmccarran-ferguson is that the amount of regulation by the states necessary to enjoy that exemption has been minimal. so i think i come to the same conclusion as chris and others on the panel. at the end of the day, we probably would be better offifmccarran­ ferguson were repealed, although, again like chris, i don't hold out a lot of hope that it would have substantial effects on the level of competition among providers of the components of health insurance, including medical malpractice insurance. i do think it's important to understand that there are at least two things that insurance companies do under the umbrella of mccarran-ferguson which at least might be important to maintain. one is certain kinds of in­ formation exchanges, and the other is standardization of the terms of insur­ ance policies. there are at least some arguments to be made that allowing insurance companies to do that allows them to achieve certain efficiencies. those ef­ ficiencies include reduction of costs and better understanding by customers of what the terms of the insurance would be. therefore, we need to be a little careful if there were a complete repeal ofmccarran-ferguson, includ­ ing with respect to the health sector, and thus insurance companies werejlo longer allowed to engage in any joint activities, that we don't lose some of those benefits as well. if i could talk briefly about what david orentlicher and tim greaney were talking about. david properly reminds us that the healthcare reform bill-i was going to say that's sailing through the congress, but this is sail­ ing at glacial speed -principally addresses the access side of the equation, but does little right now with respect to the reduction of costs. since my knowledge of this debate is on the antitrust side, i just want to say that it is with respect to the cost side, rather than the access side, that antitrust has something to contribute. 264 indiana health law review [vol. 7:225 across the spectrum of antitrust scholars -from people who are more expansionists like myself, or fojks who take a more restrictive approach there is at least a acceptance across the board that what antitrust should be doing is maximizing consumer welfare, that means, among other things, lower prices, better products, more efficiency, greater choice and so on. as i noted, it is with respect to the cost-reduction side that antitrust bas something to contribute, because the premise is the principal way one gets advanced consumer welfare is through enhanced competition. barak properly says that those consumer benefits would occur if we bad more competition, both on the provider side and on the consumer side. however, if we only have more competition on one side, we really have a second-best here. in that case, we really may not advance consumer wel­ fare. from the antitrust side, the focus needs to be on what can enhance competition, increase competition and also consumer welfare. again, we must be mindful of what barak says that sometimes more is not necessar­ ilybetter. mr. foer: i think there are two terms that we haven't elucidated sufficiently before we get to audience questions, and i think david has got a question for the panel as well. but, let me ask for some elucidation, david we hear about the exchange and the importance of an exchange. would you just spell out what that is, and the other question i'll throw to barak per­ haps, is the public option. we hear about the public option, it maybe off the table now, but i think we should still just say what it is and maybe give a hint as to its com­ petitive implications. professor orentlicher: yeah, sure. the idea of the ex­ change is, we are going to expand access by creating the ability for more people to purchase insurance who don't have it now either because their employer doesn't provide it or they can't afford it on their own, but where will they buy their insurance? what will happen is this exchange will be created, the government will oversee it, and health care insurers can apply to offer an option in the exchange for these new individuals who now can afford coverage. insur­ ance will be more affordable for people who now are discriminated against because of their pre-existing conditions, because there will be subsidies for people of limited means, because small employers that would like to offer health insurance now will have the ability to buy in, because they too will 2010] competition policy in health care 265 have subsidies. once we've created this new population of purchasers, where will they go to buy? they'll go into the exchange. the government will set it up and identify different levels of coverage based on how generous the benefits are and how much of the costs are covered by the premiums and how much are left to cover out of co-payments and deductibles. so the exchange will rate the policies for different levels of quality, and costs, and people can go in and shop and they can either buy a basic policy with minimal benefits and minimal costs, or they can go to higher benefits-higher costs plans, whichever fits them best and the hope is that the government can make it easier, because right now how do you go out and negotiate for a plan by yourself? so the gov­ ernment will set up this marketplace where you can buy, so you don't have to go out and hunt down insurers and figure out what they have to offer. then you can compare, because the government will structure it in a way that it's easy to compare the plans and generate a more competitive situa­ tion. questioner: how do we know that the insurance companies will opt in to the exchange? professor orentlicher: well, this is one of the concerns. one of the worries is that they don't have to go into the exchanges if people can buy insurance outside the exchange. one of the problems we have is that sicker people have trouble getting insurance now. well if the healthier populations buy outside the exchange and the exchange only services the people that are sick or who are a higher cost to insure, then we replicate the problem we have now. the idea of reform is to treat everybody the same; no matter whether you are healthy or sick, you pay the same premium (but older people will pay more than younger people). if it turns out that the healthier people stay out of the exchange and the sicker people go into the exchange, then the exchange plans will have to charge more money and it will undermine the whole point of this effort to make healthcare more affordable. so you are right, and that's one of the things that's being debated now. questioner: let me ask you though david, how realistic is that because you don't get a subsidy unless you are in the exchange and the sub­ sidies go up to 400% of poverty. so does it that mean that the great bulk of the 30 million new insurers will be in the exchange? 266 indiana health law review [vol. 7:225 professor orentlicher: that's a good point. i suppose it de­ pends· on how ·generous are the subsidies. it's an interesting question, be­ cause if you are earning $60,000, you are still expected to spend $6,000 in the exchange toward your insurance. so if you take healthy people out of the exchange, can you price their insurance at less than $6,000? so, it does come down to the details, how generous the subsidies are, how much by having a younger healthier population you can reduce the cost. it's an interesting question. professor greaney: and remember the exchange actually does provide an important service for the insurance companies; it reduces greatly their search and administrative costs, the marketing, and eliminates the medical underwriting they do now, because they have to take all com­ ers. so it does have a very important cost-lowering aspect by putting one-. stop shopping in place. mr. foer: it also provides the incentive for the insurance industry to be supportive of this whole reform effort, because it's going to bring them the potential of all these millions of new customers. i'll get to the au­ dience in just a second. let me ask barak to crack the question of what is a public option and what's that all about?. professor richman: okay, now a public option is the euphem­ ism created by the democrats. in politics, there always is a debate over words. just as there was a rhetorical debate over tax proposals -is it an estate tax or is it a death tax? how you describe the public option reveals how supportive you.are of it. the democrats obviously won this rhetorical debate since we all refer to the plan as a proposal.for a public option. what was the republican term? was it the "government plan"? . professor sagers: socialism. professor richman: ahh, socialism or communism. ok. so it's been observed that there are not enough insurance companies in the marketplace, there are not enough insurance options and that we have too little competition and too much monopoly. one proposed solution is to have add the government as one more player to the marketplace, to offer addi­ tional insurance plans that are operated by the government. the proposal is to offer these plans as additional options to insurance purchasers and add these offerings to the selections available at the exchange on the website. now exactly how that will be organized? would it be a profit­ maximizer the same way the insurance plans are? would it cover the same amount as the private insuran.ce plans? how will the price be determined? 2010] competition poucy in realm care 267 how politically insulated would it be? who will make coverage determina­ tions? all those are questions that really were never answered and maybe they'll never be answered if it really is off the table. but it's really quite intriguing. we don't like monopolies in this coun­ try, but nobody ever suggests that government should come up with another operating system to compete with microsoft. this is a very dramatic inter­ vention, a radical solution to the lack of competition. of course, the gov­ ernment has some experience being an insurer yet little experience designing operating systems, so the microsoft analogy isn't quite apt. the government pays for a lot of healthcare even on the private side through additions to graduate medical education. so the government has some ex­ perience doing this, it also has some experience offering flood and crop in­ surance. the idea is that if the private market is so dysfunctional and if the private insurance companies are so untrustworthy, perhaps we should just have another economic player that happens to be operated and sponsored by the government. mr. foer: let's go to the audience now and take your questions. questioner: it seems to me this exchange is grossly overstated in terms of its possible benefit when you consider that every insurer in there has to comply with the state mandates. indiana for instance has 65 mandates at the latest count. every insurer is going to have to offer a plan that covers all that stuff. so the idea that there will be an option to get a stripped-down plan or a less inclusive plan is just misleading. professor greaney: there are some studies that suggest that the cost of the state mandates is not as great as portrayed. i think the com­ monwealth fund has study that suggests that the extent of state mandates which people often cite as adding to the cost of insurance, because many providers are mandated, certain diseases, coverages are mandated, is really no larger than those found in the federal employee health benefits plan. i'll get you the cite for that; because it's often discussed in this context-i think it's in dispute as to how much mandates actually add to the total cost of insurance. professor richman: i might add that there is a lot of truth be­ hind the question, which suggests that we are only going to have competi­ tion to the degree that the marketplace allows for competition. we cannot harness the benefits of competition quite as effectively if regulatory re­ quirements restrict what insurers can offer. there are many political im­ pulses on the state and federal level that we will have to restrain if we want to have low-cost and effective competition on insurance. 268 indiana health law review . [vol. 7:225 professor greaney: · there is an article written several years ago by russell korobkin at ucla which makes the case for mandates. these mandates didn't come out of thin air. they were voted in by your state legislators. his argument is that these laws correct a market imperfec­ tion.,.._ we don't (and can't) bargain effectively for our insurance coverage, we don't carefully examine our policies to see if they cover drive-by delive­ ries and so on. so we do it through our legislature. through our legislature we make the determination that certain services should be covered and· the transaction costs of everybody trying to rewrite their insurance covet1lge to include these things is simply impractical and unrealistic. korobkin makes an interesting market justification for mandates. professor richman: it's interesting who the ''we., is though. when ''we .. go to our legislatures, often that ''we,. are the chiropractors and psychiatrists and the social workers who will lobby to have their services covered as well. questioner: the us pays more per doctor and more per nurse than other countries and some economies parsed out the differential in cost for healthcare contributed to the higher cost per provider. and i was struck that all of the antitrust people don't look at either the ama or the nuf$ing association. an md in most other countries is a three, four, or five-:year undergraduate degree while the road to becoming a doctor in the us is much more strenuous. similar constraints exist on the education and licens­ ing of nurses. so to me that's the big difference between the us and other countries. we have got a monopoly in md creation and a monopoly in nursing crea­ tion. professor richman: you are correct, there are important regu­ latory constraints on physician assistants and other non-physician health­ care workers that restrict what they can do. those limitations and other workforce regulations especially those involving licensure requirements limit how much lower-cost workers can substitute for md care. and you're also correct that the ama and other professional organizations have lobbied heavily to maintain those regulatory barriers. cross-national comparisons of the salaries paid to european doctors and american doctors, even those that adjust for the relative cost of educa­ tion, find that us salaries significantly higher by nearly 60% even after. ad­ justment. however, this is also a reimbursement problem, not just a problem about regulatory barriers and inadequate competition. moreover, notice that each medical student gets an enormous subsidy 2010] competition poucy in health care 269 in his or her residency; as big as $500,000. we also subsidize medical edu­ cation through medicare. professor orentlicher: you are right, we do need to pay at­ tention. and the problem is not so much how much we pay our doctors, but the way we pay them. part of it is the disparity between specialists and pri.;. mary care doctors. i think starting pharmacists earn more than starting pe .. diatricians in indiana, at least this was true a few years ago. a specialist makes two-three times that or more, depending on the specialty. so part of it is, we encourage our new physicians to go into-the spe­ cialties, rather than primary care. and then the fact that they are in a fee­ for-service system, rather than one based on salary or capitation.· as many people have said, the most expensive medical device is the doctor's pen. it's all those unnecessary procedures and surgeries that are ordered because that's how doctors earn their salary. actually, that it's not a salary is the problem in the way they earn their compensation. so i think you could double primary care doctors' income and keep specialties at the same compensation, but if it was all salary i think health­ care cost would go down. in terms of some of the things that aren't being addressed in the health care bills, that to me is one of the most glaring things that's just not being addressed. we need to think about how we pay our doctors. mr. foer: the antitrust laws don't protect the hospital association or the nurse· association, we do see cases being brought against the doctor cartels; david balto would have loved to tell you why that's·a waste of re­ sources. but you see those, there's actually some cases going right now, private cases, asking the question why are nurses -why is there always a nursing shortage and yet nurses are undetpaid? and there are some cases asking that question and assuming that there is some hospital collusion going on there. i understand those cases aren't doing so well. but anyway the questions get asked, there is no exemption here. for a long time in antitrust history the professions were not really considered subject to the antitrust laws, and that changed in the 60's and 70's, and professional ethics still get a great deal of credibility, but their examination is not exempt from the antitrust laws. · professor sagers: i have a question along that line for david and tim. antitrust doesn't exempt those activities, and some cases are brought, but my sense is that there bas evolved very quietly a case law for 270 indiana health law review [vol. 7:225 healthcare, and particularly for hospitals, that is in a lot of ways special. it's not a statutory exemption obviously, but it's arguably a judicial one. does that address this problem at all? hospital staffing decisions in particular are very, very hard to challenge under the antitrust laws. professor greaney: right and, rightfully so actually because the great bulk of these staff privileges cases have nothing to do with compe­ tition. typically these are challenges by physicians who have been denied staff privileges or who are thrown off the hospital's staff. there are hun­ dreds and hundreds of these cases, and i have the misfortune to have read almost all of them. a friend of mine refers to these as the ''junk food of an­ titrust," because there is far less there than meets the eye -plaintiffs un­ iformly allege anti-competitive abuses: "i was thrown off the staff because they are afraid of me as a competitive threat", ultimately the trial record reveals a fistfight in the o.r. between the doctor and somebody else, or bad medicine being practiced by the sanctioned doctor. the great majority of these cases deal with human foibles, but do not implicate competition. inte­ restingly, antitrust law has done a good job in weeding out these cases. professor sagers: maybe one brought by the dismissed doctor, but the case law doesn't distinguish that fact. importantly, a lot of court of appeals case law now holds that they are immune from section 1 liability entirely. so we have a case law developing that's also going to make it very hard for enforcement agencies to challenge, and i wonder if because of that case law that's why we don't see the agencies challenging these things. it must sometimes raise some concerns. professor greaney: you are right and for antitrust students out there, there is a lot of precedent that has developed, though not specifi­ cally on point to the kinds of issues we have discussed so far that has made antitrust cases very hard to bring in certain settings. some obstacles include antitrust standing for private suits, what organizational form constitutes a single entity, and limitations on indirect purchaser suits. most significant is a major supreme court case handed down just a couple years ago called twombly that is of special importance to private litigation; the court in­ creased the requirements for pleading a case, to the point that a plaintiff has to have an awful lot of evidence to even bring a case, and that has pushed a lot of plaintiffs cases out the door. other court decisions such as those that give short shrift to testimony by payers and others as to what the market is likely to happen, what is likely to happen in the market have an important influence on the outcome of fact-specific issues. professor huffman: what about the idea that by providing in2010] competition policy in health care 271 surance to the uninsured, we are shifting the demand curve to the right in substantial fashion. it's a whole bunch of new consumers in the system. should we not expect to see costs rise dramatically as a result? professor richman: recall that insurance is not a rival good. in other words, both of us -you and i can be insured, yet when one of us enjoys that insurance we are not limiting the supply of insurance that the other can have. so an increase in demand does not necessarily lead to an increase in price, though of course it depends on who the additional insu­ reds are. what is interesting though is whether or not subsidizing health insur­ ance will lead to an increase in consumption of healthcare services, which are rival goods. i personally think that it will lead to a significant increase in consumption, and this will lead to higher costs and likely higher prices for healthcare services. some of my research addresses these issues of how insurance affects healthcare-seeking behavior. but a lot of people think that the uninsured are getting healthcare anyway, either through emergency rooms or through charity care, or through other sorts of different delivery systems that are less efficient than through the main channels. so some people characterize the expansion of insurance merely as a redirecting people who are already receiving health care to receive that care through more efficient means. participant: the other thing to the extent there are the healthy uninsured who aren't buying it because they are not going to get their mon­ ey's worth, and now you force them to buy insurance for which they won't get their money's worth, that helps reduce cost. questioner: two questions, i am not an expert, i am not a health insurance expert. a number of speakers have implied that there has been some egregious antitrust conduct by the insurance industry over the past eight years that should have been addressed. can somebody explain what that is? and the second question is, if the issue is cost, should we also be talking about the amount of coverage? how many rounds of chemo, how many diagnostic tests do i get? my impression of most of it is patients wanting that 1% issue resolved. professor richman: i don't want to answer either question, but i want to put a remarkable irony that although you think you asked two questions, you really asked just one question, or at least both questions in­ vite the same answer. it might be said that the insurance companies' egre­ gious behavior or the behavior that many suggest is egregious is merely the conduct that you are suggesting that they should do in your second question, which is denying coverage for excessive treatment. 272 indiana heal til law review [vol. 7:225 now, many suggest that sometimes insurance companies deny cover­ age in ways that amount to abuse. sometimes they do that in ways that are misleading and rely on misrepresentations, sometimes they do that, i sup­ pose --actually i don't know, but i suppose they could also do that through blatant antitrust violations. but what's interesting about your question is that it's really the same question. a lot of people are after the insurance compa­ nies for trying to restrain the very costs that you think they should restrain. questioner: well, i took antitrust law 35 years ago. is the denial of coverage an antitrust violation in and of itself? professor greaney: our most enthusiastic critic of the insur­ ance industry has now left the building, but what he was pointing to were mostly in the merger area where there have been 400 mergers only a handful of government challenges. · now of those 400, the great majority of them did not present antitrust problems.· so i have some questions about how many should have been challenged, but clearly some should have. but david goes on to cite a long parade of horribles about insurance industry practices-and they are horrible in many cases. recissions of in­ surance policies based on a mistake or insignificant falsehood in applica­ tions for insurance, and gag clauses against physicians explaining their treatment dec~sions to patients, and all sorts of things. those are generally not antitrust issues, they may be consumer protection issues, they maybe fraud, et cetera. and he makes the case that there should be more vigorous consumer protection actions. but the link between market competition and fraud is not that clear. final word, i have this problem with finger-pointing unless we point the finger everywhere, ·because there is a lot of abuse. many of you may have· seen 60 minutes broadcast a few weeks ago with the incredible level of fraud -perpetrated by providers in the medicare system. that's being done by providers, not so much doctors, but lots of other providers, just out­ right theft. there is also plenty of inadequate care, questionable billing (''upcod­ ing") being done ·by hospitals as well. finally, maybe we should do some finger pointing in the mirror: many consumers haven't demanded or won't accept any constraints on cost of their care whatsoever. mr. foer: i've got a partial answer also. in the mccarran reform there is an additional reform that wasn't mentioned which is that the ftc would be permitted to examine the insurance industry. why is it not permit2010] competition policy in health care 273 ted? because last time they tried insurance industry lobbied through a law that said the ftc can no longer deal with that industry. alright, well, if you can't deal with the industry and if they've got an exemption from private cases, a lot of things that maybe going or may not be going on are simply never going to be unearthed. so we have a little bit of a transparency problem here in trying to an­ swer your question. professor sagers: i agree with bert completely. we don't know how much garden-variety antitrust violation there is in the insurance industry and we need to know. but because there has been partial immuni­ ty, we actually do know a little bit about conduct in this industry because insurers work a little less hard to keep their anticompetitive conduct a secret than most conspirators do. and there's plenty of evidence of garden-variety collusive conduct that doesn't involve things like denying coverage or just being nasty or fraudulent or whatever. and i can give some examples but we are running out of time. participant: and in response to your point about doctors don't consciously order tests to make money and patients were demanding more care. but actually i think the reality is that doctors respond very quickly to incentives. so the doctor in the emergency room who gets paid a fixed amount per patient, orders fewer diagnostic tests than the doctor who gets a percentage of the patient payments for tests. so doctors don't consciously think about their incentives, but they in­ ternalize their cost structure, their financial incentives. there is a famous study comparing british and us doctors probably 30 years ago now, where british doctors say, we give appropriate levels of care and american doc­ tors give too much care. and american doctors say, we give appropriate levels of care and british doctors give too little care. they both internalized their financial incentives and thought they were practicing appropriately. and i think that's true throughout medicine. and patients respond to a doctor's offer of care. the patients don't know what to ask for, but if the doctors offer something or if doctors are complaining because they are get­ ting squeezed by managed care, that's what makes patients unhappy-when doctors feed them the complaints. questioner: i think you referred to a case in the supreme court [called american needle]? 274 indiana health law review [vol. 7:225 professor richman: actually it's a really neat case. the na­ tional football league is a joint venture of 30 individual teams. these teams, were all separate like the colts. they are a single company. they maximize profits as a single company, but these 30 teams come together to cooperate in a number of different ways. one of course is to schedule football games, develop common rules and playoff structures, and do all those things that are required to produce the games themselves. but they cooperate in a bunch of other ways as well. one way they decided to cooperate is to jointly market their logos for their sporting apparel. they thought, look, if we just hire one guy to do it for all 30 teams, we'd all make more money than if we'd each hire somebody in­ dividually. so they got together, they issued an exclusive license to reebok, and the person they didn't hire is american needle. american needle says, hey! you can't do that. this is a conspiracy. all 30 of you, you represent the en­ tire marketplace for nfl sports logo, you're all colluding with each other and kicking me out as violation to the antitrust laws. american needle lost the trial, they lost at the appellate level, and then they appealed to the supreme court. the nfl said, hey, i've got an idea! maybe by taking this to supreme court i can advance a certain argu­ ment that will get me out of section one scrutiny forever. i want to tell the supreme court that even though we are 30 teams, we really are one entity, and as one entity we cannot collude, because you cannot collude with your­ self. so what this has become is really a two-issue appeal. one is, is the nfl a single entity, and therefore could never collude illegally? and the second is, if they are not a single entity, is this a form of il­ legal collusion? and in disclosure, rve written a brief representing the nfl coaches association, which really felt strongly about that first issue. the second issue they didn't feel strongly about, and it's quite possible that the exclusive joint-licensing agreement is a pro-competitive collaboration. but what's problematic is that if this is a single entity that cannot illegally col­ lude, that is, cooperation among its separate parts is akin to gm's divisions colluding with each other, then they can set limits on certain kinds of com­ petition between the teams. specifically, the league can permit the teams to collude on things like coaches salaries. now the reason this came up here is because we have lots of different participants in the medical community that cooperate in a whole bunch of ways. doctors come together and create networks, hospitals come up with 2010] competition poucy in health care 275 networks, and a lot of these collaborations you might say are fairly pro­ competitive. they come together, for example, to develop a common billing system~ they come with electronic medical records, which is too expensive for any one doctor'.s practice to do but is possible when they all come to­ gether and cooperate. but also they come together and collaborate in very anticompetitive ways, and the idea that chris has advanced is, if american needle gives the nfl teams wide latitude to collude, so much so that they actually get some kind of designation that they cannot illegally collude, then that could extend to lots of healthcare circles. doctors who cooperate · -sometimes pro­ competitively and sometimes anti-competitively might be beyond the reach of the law, and prosecutors or plaintiffs might not be able to challenge anticompetitive collusion. mr. foer: depending on how the supreme court deals with this very complicated issue, it could give -first of all it could revolutionize sports, all leagues could then become able to act as monopolists, ·and it could have spillover effects in all other industries. but it's tough case to fig­ ure out exactly how you say the different we want to encourage joint ven­ tures, and collaborations on certain occasions, but we don't want them we don't want that ability to be overbroad and overused and undermine compe­ tition. barbara l. atwell barbara atwell is a member of the health law faculty at pace law school. the focus areas of her courses include bioethics, regulation of health care professionals, medical malpractice and health care system organization. prior to joining pace law school in 1986, professor atwell was an associate at the law firm of arnold & porter in washington, d.c. she is a graduate of smith college and columbia law school. she also clerked for the honorable nathaniel r. jones on the sixth circuit court of appeals. obesity, public health, and the food supply barbara l. atwell* table of contents i. lntroduction ................................................................................... 3 ii. obesity in america ......................................................................... 6 a. the food supply .......................................................................... 9 iii. food democracy ........................................................................... l8 a. taxing unhealthy foods ............................................................ l9 b. using the spending power to subsidize healthy eating ............ 20 c. education and awareness of healthy food choices ................. 22 i. the food democracy movement ......................................... 25 n. conclusion ..................................................................................... 27 the epidemic of obesity is a vast and growing public health problem. . . . "personal responsibility surely . .. play[s] a role, but we also live in a 'toxic environment' that in many ways discourages healthy eating . . . . there's the incessant advertising and marketing of the poorest quality foods imaginable. to address this epi­ demic, you 'd want to make healthful foods widely avail­ able, inexpensive, and convenient, and unhealthful foods relatively less so. instead we've done the opposite. "1 i. introduction it is undisputed that obesity is one of the major public health concerns of our day. obesity is plaguing the nation in unprecedented and staggering num­ bers. according to the centers for disease control ("cdc"), approximately thirty percent of american adults are obese.2 an estimated sixty-five percent * associate professor of law, pace university, white plains, new york. j.d., 1983, columbia university, new york, new york; b.a., 1977, smith college, northampton, massa­ chusetts. i would like to thank my research assistant nicole-celina urbont for her assistance. 1 craig lambert, the way we eat now: ancient bodies collide with modern technol­ ogy to produce a flabby, disease-ridden populace, harv. mag., may-june 2004, at 50, 51-52 (quoting david ludwig, associate professor of pediatrics, harvard medical school). 2 ctrs. for disease control&prevention, u.s. dep'tof heal til& human servs., facts .about obesity in tile united states 1 (2005), available at http://www.cdc.gov/pdf/facts_about_obesity_in_the_united_states.pdf[hereinafterfacts 4 indiana health law review [vol. 4:1 are overweight or obese. 3 childhood obesity is also on the rise, as are diseases, such as type 2 diabetes, that are often linked to obesity.4 the cdc estimates that obesity contributes to 112,000 deaths per year,s and it explains that,"[ o ]ver the past two decades obesity rates have doubled in adults, and the percentage of children who are above their normal weight has doubled during the same pe­ riod. the percentage of adolescents who are above their normal weight has tripled."6 as a result of the staggering increase in obesity, it is predicted that for the first time in history, this generation will have a shorter life expectancy than its parents. 7 the toll that obesity takes on society is measured not only in terms of the deaths it causes, but also in terms of the quality of life for those living with the disease. in addition to diabetes, obesity "is an important risk factor for serious diseases like ... heart disease, some cancers, and arthritis,"8 and is associated with a variety of mobility challenges. thus, obese individuals are likely to miss more days of work, incur greater health care costs, and undergo family disrup­ tions as a consequence.9 the steep rise in obesity follows closely on the heels of significant changes to the food supply. ingredients like trans fat and high fructose com syrup are of relatively recent vintage. typical grocery store fare now consists largely of preservative laden processed foods that are not particularly healthy. even unprocessed foods like fruits and vegetables are likely to contain pesti­ cides, unless the consumer pays a premium for organic altematives.10 meat and about obesity]. this constitutes approximately sixty million adults. id see infra note 14 and accompanying text. 3 ctrs. for disease control & prevention, u.s. dep't ofhealth & human servs., over­ weight and obesity: frequently asked questions, http://www.cdc.gov/nccdphp/dnpa/obesity/ faq.htm [hereinafter overweight and obesity] (last visited apr. 11, 2007). 4 pub. health serv., office of the surgeon gen., u.s. dep't ofhealth & human servs., the surgeon general's call to action to prevent and decrease overweight and obesity, http://www.surgeongeneral.gov/topics/obesity/calltoactionlfact_adolescents.htm [hereinafter surgeon general's call] (last visited apr. il, 2007). see infra notes 15-19 and accompanying text. the surgeon general's report indicates that the incidence of overweight adolescents tri­ pled during the preceding two decades. surgeon general's call, supra. 5 cms. for disease control & prevention, u.s. dep'tof healrn& humanservs., f'requentl y asked questions about calculating obesity-related risk 1-2 (2005), avail­ able at http:/ /www.cdc.gov/pdf /frequently_ asked_ questions_ about_ calculating_ obesity -related_ risk. pdf (hereinafter calculating obesity]. 6 id. at2. 7 see infra note 19 and accompanying text. 8 calculating obesity, supra note 5, at 2. 9 see generally infra notes 27-28 and accompanying text. 10 the common understanding of the term "organic" is that it refers to foods that are free of chemicals and pesticides. there has been confusion surrounding the word "organic", and it has been defined differently by different organizations. the international federation of organic agriculture movements ("!foam"), for example, provides the following definition: '"organic agriculture is an agricultural system that promotes environmentally, socially, and economically sound production offood . . . . in this system, soil fertility is seen as the key to successful pro­ duction. working with the natural properties of plants, animals, and the landscape, organic 2007] obesity, publlc health, & food supply 5 poultry animals have often been fed diets of hormones and antibiotics, unless the consumer can find organic or free range products that, like organic fruits and vegetables, are generally more expensive than their conventionally fed counterparts. 11 thus, one of the challenges we face in eradicating obesity is improving the quality of the food supply. arguably, the food supply needs a fundamental restructuring. this article proposes a three-part approach to improve the food supply. specifically, it explores government taxing and spending, two traditional public health tools, and suggests that both of these governmental powers can be used to make healthier foods more readily available at reasonable prices, while in­ creasing the cost of less healthy alternatives. finally, it proposes that we pro­ mote a true "food democracy" 12 through the creation of an education and awareness campaign. this campaign would not only better educate americans about proper nutrition but would also focus on how we can change our entire relationship with food. it would encourage consumption of locally grown whole foods and sensitize individuals to the need for sustainable agriculture. it would also address the benefits of taking the time for balanced, sit-down meals rather than eating on the run. part ii of this article outlines the problem of obesity in america. part ill explores the current state of our food supply. part iv proposes the implementa­ tion of 1) taxing, 2) spending, and 3) educational and awareness modifications to improve the food supply and to begin to shift our consciousness surrounding food. fanners aim to optimize quality in all aspects of agriculture and the environment."' michael sligh & carolyn christman, rural advancement found. int'l-usa, who owns organic? the gwbal status, prospects, and challenges of a changing organic market l (2003), available at http://www.rafiusa.org/pubs/organicreport.pdf (quoting the ifoam definition). due to uncertainty surrounding the definition of"organic," in 1990 con­ gress enacted the organic foods production act, 7 u.s.c. §§ 6501-6522 (2000). one of the purposes of the act is to create "national standards governing the marketing of certain agricul­ tural products as organically produced products ... . "!d. § 6501. there now exists a national organic program, 7 c.f .r. pt. 205 (2006), that establishes a list of approved and disapproved substances associated with organic farming. 11 the added cost of organic alternatives has been coined by the food industry as the "price premium." sugh & christman, supra note l 0, at 13. 12 e.g., neil hamilton, food democracy and the future of american values, 9 drakej. agrlc. l. 9, 12, 19, 23 (2004). i thank professor hamilton for the term "food democracy." for a description offood democracy, see infra notes 120-22 and accompanying text. 6 indiana health law review [vol. 4:1 ii. obesity in america "[oj besity is america's fastest-growing health problem .... "13 according to the cdc, approximately sixty million adults are obese. 14 while the cdc does not report the percentage of obese children and adoles­ cents, it does state that the rate of overweight children has doubled since 1980 and has tripled among adolescents during the same time period. 15 our over­ weight youth are therefore at risk of spending the rest of their lives exposed to the health risks of obesity.16 in fact, more than half of the overweight children between the ages of five and ten show signs of being at risk for heart disease.17 13 paul krugman, free to choose obesity?, n.y. times, july 8, 2005, ata23. see also facts about obesity, supra note 2 [hereinafter krugman, free to choose obesity?] (''obe­ sity rates are soaring in the u.s."). 14 facts about obesity, supra note 2. see also paul krugman, girth of a nation, n.y. times, july 4, 2005, at a13 [hereinafter krugman, girth of a nation]. for adults, obesity is defined as having a body mass index (''bmi") of thirty or higher. overweight and obesity, supra note 3. morbid obesity, also referred to as severe or extreme obesity, is defined as having a bmi of forty or more, which generally equates with being approximately 100 pounds more than one's ideal weight. am. obesity ass'n, aoa fact sheets, http://www.obesity.org/subslfastfacts/morbid obesitys.html (last visited apr. 11, 2007). overweight in adults is defined as having a bmi between 25 and 29.9. overweight and obesity, supra note 3. 15 calculating obesity, supra note 5; surgeon general's call. supra note 4. the bmi of children and adolescents is interpreted differently from that of adults. "for children and teens, bmi ranges above a normal weight have different labels (at risk of overweight and over­ weight). additionally, bmi ranges for children and teens are defined so that they take into ac­ count normal differences in body firt between boys and girls and differences in body firt at various ages." overweight and obesity, supra note 3. cf. lisa smith & bryan a liang, child­ hood obesity: a public health problem requiring a policy solution, 9 j. med. & l. 3 7 (2005) (suggesting that broad-based policy measures are needed to address the growing problem of childhood obesity); heather l. hinds, pediatric obesity: ethical dilemmas in treatment pre­ vention, 33 j.l. med & ennes 599 (2005) (examining the ethical dilemmas posed by using adult obesity treatments on children); alan j. zametkin, christine k. zoon, hannah w. klein & suzanne munson, psychiatric aspects of child and adolescent obesity: a review of the past 10 years, 43 j. am. acad. cmid adolescent psycidatry 134, 134-50 (2004); marshall l. wilde, bioethical and legal implications of pediatric gastric bypass, 40 wh..uameitel. rev. 575 (2004) (looking at the complexity of issues faced in determining the propriety of gastric bypass surgery for children); william h. dietz, mary groves bland, steven l. gortmaker, meg molloy & thomas l. schmid, policy tools for the childhood obesity epidemic, 30 j.l. med. & ennes 83 (2002) (advocating for a range of policy changes to address childhood obesity). 16 see surgeon general's call supra note 4 (''overweight adolescents have a seventy percent chance of becoming overweight or obese adults.j. cf. abby ellin, for overweight children, are 'fat camps' a solution?, n.y .times, june 28, 2005, at fl (examining the poten­ tial for long-term weight loss through summer camps dedicated to educating children on how to eat right and exercise). 17 facts about obesity, supra note 2 ("sixty-one percent of overweight 5to l 0-year2007] obesity, pubuc heal til, & food supply 7 moreover, type 2 diabetes, which was once thought to affect only the adult population, is now appearing in our youth in alarming numbers.18 as one scholar noted, "our children are projected to have a shorter life expectancy than their parents ... they are being harmed more by poor diet than by exposure to alcohol, drugs, and tobacco combined."19 the cdc estimates that obesity contributes to 112,000 deaths in the united states per year. 20 this figure is substantially lower than the cdc's pre­ vious estimate of 365,000 obesity-related deaths per year. 21 the cdc revised its estimates based on a nationally representative study of adults. although it is clear that obesity increases the chance of death, 22 prior estimates correlated the number of obesity-related deaths to the reported 400,000 annual tobacco-related deaths. some suggest that the new lower figure reflects better treatment and management of obesity-related illnesses. 23 whatever the correct figure, obesity remains a major and growing problem in the united states. the health risks associated with obesity range from heart disease and dia­ betes, mentioned above, to hypertension, stroke, breast cancer, colon cancer, gallbladder disease, arthritis, sleep disturbances, breathing problems, and physi­ cal disability.24 obesity also increases the likelihood of back problems, knee problems, and other ailments associated with movement and dexterity.25 the facts about obesity in the united states raise several concerns. first, the number of obese individuals is staggering. second, the rate has been grow­ ing rapidly since 1980. third, the increased rate of overweight children and olds already have at least one risk factor for heart disease, and 26% have two or more risk fac­ tors."). 18 see, e.g., ctrs. for disease control & prevention, u.s. health & human servs., dia­ betes projects, www.cdc.gov/diabeteslprojectsfcda2.htm (last visited apr. 11, 2007); marcelle s. fischler, no more mystery meat, n.y. times, oct. 8, 2006, at§ 14cn, at 1; smith & liang, supra note 15, at 41. children who suffer ftom type 2 diabetes are at risk for other complica­ tions including "kidney disease, blindness, and amputations." facts about obesity, supra note2. 19 smith & liang, supra note 15, at42 (statement of professor david katz ofthe yale university school of medicine). 2° calculating obesity, supra note 5. 21 id. at 1. these deaths were based on estimates of poor nutrition and physical inactiv­ ity. /d. 22 see id. see also katherine m flegal, barry i. graubard, david f. williamson & mitchell h. gail, excess deaths associated with underweight, overweight, and obesity, 293 j. am. med. ass'n 1861, 1864 (2005), available at http://jama.ama-assn.orgfcgilcontent/full/293 /15/1861 ?eaf. the study found that being overweight with a bmi of between 25 and 29.9 did not cause excess deaths overall. id at 1863. 23 see, e.g., flegal, graubard, williamson & gail, supra note 22, at 1861 ("the impact of obesity on mortality may have decreased over time, perhaps because of improvements in pub­ lic health and medical care."); krugman, girth of a nation, supra note 14 (citing a new study that appeared to reject the view that obesity has a large effect on life expectancy). 24 calculating obesity, supra note 5. 25 see id. ("obesity ... is linked to ... negative effects on physical ability, mobility, and other quality-of-life measures."). 8 indiana healm law review [vol. 4:1 adolescents raises concerns about the long-term consequences to this popula­ tion?6 finally, the costs, both financial and societal, of the obesity epidemic cannot be ignored. an estimated fifty-two billion dollars in 1995 and seventy­ five billion dollars in 2003 were spent on direct health care costs attributable to obesity. 27 societal costs, including disruptions in family and employment rela­ tionships, also cannot be ignored. therefore, even if the mortality rates associ­ ated with obesity are in dispute, the morbidity rates remain serious and costly?8 the causes of obesity are twofold. some have a genetic condition that leads to obesity. genetically caused obesity, however, represents only a small fraction of the obese population. 29 the more common causes of obesity are behavioral, or a combination of genetic and behavioral factors. 30 some people eat too much, others eat the wrong kinds of foods, and some do both.31 another behavioral cause of obesity is the lack of adequate exercise. 32 nonetheless, the 26 see smith & liang, supra note 15, at 47. 27 facts about obesity, supra note 2. indirect costs, of course, are even greater. 28 krugman, girth of a nation, supra note 14 ("[m]ortality isn't the only measure of health. there's no question that obesity plays an important role in many diseases that diminish the quality of life and, crucially, require expensive treatment."). 29 see surgeon general's call, supra note 4. while acknowledging that genetics can be an important factor in obesity, the surgeon general's report states that "(o]verweight in chil­ dren and adolescents is generally caused by lack of physical activity, unhealthy eating patterns, or a combination of the two.'; /d. cf obesityinamerica.org, recent advances in obesity re­ search, www.obesityinamerica.org/pdf/whyarepeopleobese.prlf: at 62 (last visited apr. 11, 2007) (discussing the relationship between leptin, a hormone secreted by fi1t cells, and obesity, and noting that many overweight individuals have high leptin levels in their blood). illtimately, "[ o]besity is truly multifactorial.'' id 30 brooke courtney, is obesity really the next tobacco? lessons learned from to­ bacco obesity litigation, 15 ann. healml. 61,69 (2006) ("the surgeon general has empha­ sized that behavioral and environmental factors play significant roles in the [obesity] epidemic."). 31 this can include emotional overeating and other eating choices that are not entirely rational. prevention.com, psychological reasons for emotional eating, www.prevention.com/topic/0,5768,sl-4-64-185-0-0,00.html (last visited feb. 22, 2007) (provid­ ing a list of over twenty-five articles written on the psychological reasons for emotional eating). see also krugman, free to choose obesity?, supra note 13 ('"[a]t least some food consump­ tion is almost certainly not rational."' (quoting david cutler, edward glaeser, and jesse shapiro of harvard university in a 2003 paper that provides an economic analysis of obesity)). irra­ tional food choices may be particularly prevalent among children and adolescents, where the rise in obesity is at its greatest. /d. 32 this is of special concern in our increasingly sedentary lifestyle that often centers on sitting before a screen, whether that screen is a television screen, a computer screen, playstation 2, playstation 3, gameboy, nintendo os, x-box 360, a blackberry, or a cell phone screen. we have moved from a largely agrarian society where physical field worlc was the norm to an indus­ trialized society that involves sitting at a desk and computer. on the whole, therefore, we have become less physically active. experts generally agree that a sedentary lifestyle is another major factor in the obesity picture. see nat'l inst. of envtl. heai..m sciences, u.s. dep't of heai..m& human servs., obesity and your environment: a "weighty" subject! (2006), http://www .niehs.nih.govlkids/weight.htm. 2007] obesity, pubuc health, & food supply 9 focus of this article is on the food supply and specifically, the difficulty access­ ing healthy, affordable food choices. a. the food supply what we eat has changed more during the past thirty years than in the previous thirty thousand. trans fats, genetically engineered soybeans, livestock pumped with growth hormones and fed slaughterhouse waste, chicken mcnuggets-nobody 'sever eaten this stuff be­ fore. we've become a nation of guinea pigs, the sub­ jects in a vast scientific experiment, waiting to see what happens when human beings eat too much industrialized food. much of it tastes and smells pretty good. the pleasure, however, doesn't last long. learning where our modern mcfood comes from and how it's made and what it's doing to the world leaves a bitter aftertaste. 33 the food supply in america is largely unhealthy. a walk through a typi­ cal grocery store demonstrates this fact. whether you walk through the sugar­ laden cereal aisle, cookie and cake section, or jelly and jam section, or you pe­ ruse the high-sodium and often high fat pretzel, potato chip, and snack aisle, you are inundated largely with processed, unhealthy choices. a turn to the fro­ zen food section further highlights the problem. here you will fmd an assort­ ment of processed foods that are largely filled with sugar, sodium, fat, or all three. 34 moreover, many products include numerous additives that are not only difficult to pronounce but have no apparent connection to a natural food sub­ stance.35 33 eric schlosser, forward to anna lappe & bryant terry, grub: ideas for an urban organic kitchen, at xiii (2006) [hereinafter schlosser forward]. 34 on the other hand, the frozen food section typically includes some relatively healthy alternatives to the traditional meat and potatoes frozen dinner. these include unprocessed fro­ zen fruits and vegetables. much greater attention is now being given to the concerns associated with the food supply than in the past. perhaps the movie "super size me" brought the greatest degree of public awareness to the high fat, high sugar, high sodium and extensive use of chemi­ cals in our food supply. super size me (morgan spurlock 2004 ). another publication that has had mass market appeal concering obesity is the book "fast food nation." eric schlosser, fast food nation: the dark side of the all-american meal (2001). see a/so eric schlosser & charles wilson, chew on this: everytiiing you don't want to know about fast food (2006); marion nestle, food politics: how the food industry influences nutrition and realm (2002). not all products at the traditional grocery store are unhealthy. a variety ofhealthy alternatives exist, and consumer demand is enhancing the qual­ ity of grocery store fare. see infra notes 69-73 and accompanying text. 35 see, e.g., whole foods market, quality standards: unacceptable food ingredients, http://www.wholefoodsmarket.com/products/unacceptablefoodingredients.html (last visited feb. 10 indiana health law review [vol. 4:1 a savvy consumer, aware of the pitfalls of frozen and other processed foods, may instead approach the produce, meat, poultry, and fish sections of the supermarket, where unprocessed items are readily available. the choices in these departments, while perhaps healthier than some processed alternatives, are likely to yield another set of health risks. the fruits and vegetables in the produce section are likely to be laden with pesticides.36 at the meat and poultry counter, the consumer may select animal products that were injected with hor­ mones and antibiotics, chemicals that can easily pass through to the human body. 37 of course the fish department must be meandered carefully, lest the consumer come home with mercury-contaminated selections. 38 the dairy sec­ tion, which offers items like milk, juice, and cheese, suffers from the same ail­ ments as the produce and meat sections because these products are derived 22, 2007). among whole foods' list of unacceptable food ingredients are caprocaprylobe­ henin, dimethylpolysiloxane, and ethyoxquin. id 36 see lappe& terry,supranote33, ats-16. theauthorsnotethat"[b]y 1969,60,000 different pesticide products had been licensed by the [united states department of agriculture]. but licensed didn't necessarily mean safety-tested .... " !d. at 9. moreover, the use of pesti­ cides arguably has not made food growing easier or more efficient "though we're blanketing the country with insecticides, we're having no easier time with insects. while the volume of insecticide applied has increased tenfold since 1945, crop loss to insects has nearly doubled, up from 7 percent to 13 percent, according to the [united states department of agriculture's] own data." !d. at 17. the reason for this is that insecticides create resistant insects. see id thus, farmers use more and stronger forms of insecticides to combat the problem. see id addition­ ally, the environmental protection agency also acknowledges that, depending on consumption patterns, "[l]aboratory studies show that pesticides can cause health problems, such as birth defects, nerve damage, cancer, and other effects that might occur over a long period of time." u.s. envtl. protection agency, pesticides and food: health problems pesticides may pose, www.epa.gov/pesticides/food/risks.htm (last visited apr. 11, 2007); cj. technical dn., pub. serv.promctdep't,consumersunionofu.s.,inc.,doyouknowwhatyou'reeatino? an analysis of u.s. government data on pesticide residues in foods passim (1999), http://www.consumersunion.org/pdf7do _ you_know.pdf (looking at the toxicity index of vari­ ous foods measured by the frequency of pesticide detection). 37 see laurie garrett, betrayaloftrust: limcouapseofgwbalpubuchealm 467-69 (2000). garrett points out that the united kingdom and most ofeurope banned the use of antibiotics as growth promoters. id at 468. the united states' centers for disease control conducted a study over the period of200 1-2002 and found 148 chemicals in human blood and urine. crrs. for disease control & prevention, u.s. dep't of healm & human servs., third national report on human exposure to environmental chemicals 1 (2005), avail­ able atwww.cdc.gov/exposurereport/3rd/pdf7thirdreport.pdf("blood and urine levels reflect the amount of the chemical that actually gets into the body from the environment''). see also lappe & terry, supra note 33, at 34 ("[o]veruse of antibiotics in [animal] factory farms is leading us toward a precarious future in which our best (and sometimes only) defense against certain bacte­ ria will be dramatically reduced, if not rendered useless, by antibiotic resistance."). 38 u.s. envtl. protection agency, u.s. dep't of healm & human servs., what you need to know about mercury in fish and shellfish 1 (2004), available at http://www.cfsan.fda.gov/-acrobat/admehg3b.pdf("[n]early all fish and shellfish contain traces of mercury .... some ... contain higher levels of mercury that may harm an unborn baby or young child's developing nervous system."). the report also notes that risks to others depend upon the level of fish and shellfish consumption. !d. 2007] obesity, pubuc health, & food supply 11 from fruit, vegetable, and animal products. it is very difficult, then, even for a health-conscious consumer, to find sufficiently healthy food choices at the local grocery store. "[g]iven that we are expected to monitor salt ... and other po­ tential dangers, a trip through the supermarket is ... beginning to resemble tak­ ing the sat. "39 the food challenges at the grocery store pale in comparison to those at other establishments. fast food restaurants, for example, serve notoriously un­ healthy foods. the 2004 film, "super size me" highlighted the poor quality of food at mcdonald's along with inappropriately large portion sizes.40 although mcdonald's has since introduced some healthier food choices including salads, yogurt with fruit and granola, and sliced apples with low fat caramel, and has eliminated its super-sized portions altogether, its traditional offerings are still high in fat and calories.41 also, the mcdonald's "dollar menu" is still alive and well, rendering many traditional offerings high in fat and calories more afford­ able. the food quality at conventional restaurants, however, is more difficult to assess because there is no requirement that restaurants provide nutritional in­ formation to their patrons. 42 congress has adopted limited regulations of the ingredients and nutritional value of assorted restaurant menu items.43 for now, the consumer who chooses to dine out can inquire about the ingredients used in various menu selections and choose restaurants that he or she believes will pre­ pare healthy, nutritious foods. food establishments, such as movie theatres, sports stadiums, and amuse­ ment parks, continue to adhere to some of the unhealthiest offood choices. for example, amusement parks typically sell cotton candy, which is pure sugar,44 39 nina teicholz, op-ed., nuggets of death, n.y. times, apr. 16, 2006, § 4, at 13. 40 super size me, supra note 34 (documenting filmmaker morgan spurlock's weight­ gain journey of eating a mcdonald's-only diet for a month and gaining more than twenty pounds). this film also touched on the poor quality offood at many of america's schools. it was perhaps this film that initiated a reevaluation of food in society. 41 see, e.g., mcdonald's quauty & nutrition info., mcdonald's inc., mcdonald's usa nutritional facts for popular menu items (2007), available at http:/ /app.mcdonalds.com/countries/usalfoodlnutrition/categories!nutritionfacts.pdf. a quarter pounder with cheese, for example, contains 51 0 calories, 26 grams of fat, 1190 milligrams of sodium, and 1.5 grams of trans fat. !d. a large order ofmcdonald's french fries has 570 calo­ ries, 30 grams offat, 330 milligrams of sodium, and 8 grams of trans fat. !d. 42 smith & liang, supra note 15, at 49. 43 /d. ("[t]hese labels are extremely limited; for example, they often include only a pic­ ture of a heart to define that the meal is heart healthy or a special section of the menu that is designated to be 'light fare.'"). see also federal food, drug, and cosmetic act, 21 u.s.c. § 343(q)(5)(a)(i) (2000) ("fdca"). several of the fdca's food labeling requirements do not apply to "food which is served in restaurants or other establishments in which food is served for immediate consumption." !d. restaurants rarely have nutritional information available. see smith & liang, supra note 15, at 49. 44 part of the attraction of cotton candy is watching it being converted from sugar gran­ ules to its "cotton" consistency. 12 indiana heal til law review [vol. 4:1 and funnel cakes, which are deep fried, 45 among other unhealthy foods. movie theatres are known for popcorn which reportedly has 910 calories and seventy­ one grams of fat in a medium-sized portion, 46 and sports stadiums are associ­ ated with hot dogs47 and peanuts. aside from peanuts, these offerings are not a model for healthful eating, and even peanuts need to be eaten in moderation because they are high in fat and calories.48 additionally, virtually all eating establishments sell coca-cola, pepsi, and other soft drinks, which are not par­ ticularly healthy food choices either.49 another food venue that has received a great deal of attention, particularly given the significant rate of overweight children, is schools. 50 pursuant to the national school lunch and breakfast programs, millions of children are eating up to two meals per day at school. 51 therefore, it is imperative that those meals provide safe and adequate nutrition. a 1992 study found that school lunches failed to adhere to healthy stan­ dards of fat, saturated fat, carbohydrates, and sodium. 52 as a result the national 45 fried foods are high in fat and can lead to heart disease. bobbie hasselbring, how do fried foods affect ~ risk?, in heart healrn: cholesterol (2001), http://health.discovery.com/centerslarticles/articles.html?chrome=el4&article=lc_25&center=p 05 (last visited feb. 22, 2007) ("you're at greater risk for high blood cholesterol and heart dis­ ease if you eat a diet that often includes deep-fried or breaded foods, which are high in fat."). 46 dietfacts.com, movie theatre popcorn, buttered, medium sized (11 cups), popped in coconut oil, www .dietfacts.comlhtml/itemsl23660.htm (last visited apr. 18, 2007). see also karen collins, ins and outs ofpopcorn, www.keepkidshealthy.com/nutritionlins_outs_ popcom.html (last visited apr. 11, 2007) ("[l]he fat content in ... [a large bucket of movie popcorn with added butter is] comparable to three to five big macs or six to 10 candy bars."). 47 dodger stadium hot dogs reportedly contain 190 calories and twenty-one grams of fat. eight grams of which are saturated fat. dietfacts.com, dodger stadium dodger dogs: extra­ long meat wieners, www.dietfacts.com/html/items/12472.htm (last visited feb. 24, 2007). 48 an ounce of dry roasted salted peanuts contains 166 calories and 14.1 grams of fat. the peanut inst., peanuts-mother nature's whole food, www.peanut-institute.org/ nutritionbasics.html (last visited feb. 24, 2007). the fat in peanuts is largely unsaturated rather than saturated. /d. peanuts are also a good source of protein and minerals. id 49 on its web site, coca-cola gives nutritional information based on an eight ounce serving size, which is much smaller than the typical twenty ounce bottle or twelve ounce can. eight ounces of coca-cola contains ninety-seven calories, thirty-three milligrams of sodium, twenty-three milligrams of caffeine. and twenty-seven grams of carbohydrates. the coca-cola company,soitdrinknutritionallnformationforcarbonatfd.8everages,www2.coca­ cola.com/maivgoodanswer/soft_drink_nutrition.pdf(2006)(lastvisitedapr.ll,2007). absent from the list are the number of grams of sugar per serving. /d. 50 susan lynn roberts. school food: does the future call for new food policy or can the old still hold true?, 7 drakej. agric. l. 587, 588 (2002)(examiningthehistotyofschool food programs and revealing some of their nutritional shortcomings). 51 /d. ("in the fiscal year 2000, over 27.4 million children were fed lunch each day (with over 14 million free or reduced cost) at a yearly cost of$5.56 billion .•.. in the fiscal year 2000, an average of 7.55 million children ( 6.4 million at free or reduced cost level) were fed breakfast each day.'') see generally national school lunch act, 42 u.s.c. §§ 1751-1769 (2000). 52 john burghardt & barbara devaney, food & nutrition sbrv., u.s. dep't 2007] obesity, pubuc heal'ih, & food supply 13 school lunch and breakfast programs initiated changes aimed at making school fare more nutritious. as of 1996, congress required that school lunch and breakfast programs comply with the dietary guidelines for americans in order to receive federal reimbursement for the meals. 53 regardless of the venue, there are two ingredients that permeate the food supply to such an extent that they are difficult to avoid: high fructose com syrup and trans fat. 54 developed in the early '70s ... high-fructose com syrup instantly became a hit among food industry ceos be­ cause ... it can be six times as sweet as cane sugar and is cheaper to produce in part because it's made from com, which is heavily subsidized by our taxes. 55 studies suggest that we metabolize high fructose com syrup differently than ordinary sugar, and consumption of high fructose com syrup is a major factor in weight gain. 56 "scientists have also shown that ... [high fructose com syrup] doesn't send the same 'i'm full' signal to the brain as when we consume sugar.'.s7 it also raises several other health concerns, including the way in which it is metabolized by the liver8 and its association with irritable bowel syndrome. 59 aoric., the school nutrition dietary assessment stijdy: summary of findings (1993), availableathttp://eric.ed.goviericdocslda.talericdocs2/content_storage_ol/ooooooob/80/23 /3c/4a.pdf. 53 see national school lunch act, 42 u.s.c. §1753 (2000); national school lunch program, 7 c.f .r. § 210.2 (2006) ("lunch means a meal service that meets ••• applicable nutri­ tion standards."). not surprisingly, fast food has also infiltrated america's hospitals. a 2002 study found that four out often hospitals have a fast food restaurant on-site. andrew weil, surgery with a side of fries, n.y. 'dmes, july 6, 2006, at a21. 54 see dayna winter, are these foods really healthy?, prevention.com, http://www. prevention.comlarticlel0,5778,sl-3-58-135-4835-1-p,oo.html (last visited feb. 24, 2007) ("these two ingredientstrans fat and high fructose com syrupare in 40 percent of the foods americans eat everyday.''). the number of foods with trans fat has presumably gone down since the fda implemented regulations that require trans fat to be separately labeled on most pack­ aged foods. nutrition labeling of food, 21 c.p.r. § 101.9(cxii) (2006). 55 see lappe & terry, supra note 33, at 35. 56 ld. 57 id. (quoting sharon s. elliottetal.,fructose, weight gain, and the insulin resistance syndrome, 16 am. j. clinical nutrition 911, 911-22 (2002)). 58 see id high fructose com syrup can result in higher levels oftriglycerides, which are associated with heart disease and stroke. id 59 id in addition to trans fat and high fructose com syrup, there is currently a debate about the safety of genetically modified foods. "in 2003, about 167 million acres ... grown by 7 million farmers in 18 countries were planted with transgenic crops .... " human genome project info., what are genetically modified (gm) foods?, http://web.oml.gov/sci/ techresources/human _ genomelelsi/gmfood.shtml (last visited feb. 24, 2007). while not di­ rectly tied to the issue of obesity, genetically modified foods, the use of pesticides and other food hazards arguably reflect a failure to adhere to a principle espoused by some environmental14 indiana heal til law review [vol. 4:1 trans fat, or trans fatty acids, were developed in the 1940s. 60 when vege­ table oil is hydrogenated, the result is trans fat 61 trans fat converts unsaturated fats into saturated ones. 62 trans fat lowers good cholesterol and raises the bad cholesterol, heightening the risks for heart disease. 63 therefore, it is advisable to eliminate as much trans fat as possible from one's diet.64 for the food in­ dustry, though, trans fat is appealing because it gives products a longer shelf life and is cheaper than traditional butter or lard. 65 because of its unhealthful characteristics, the united states food and drug administration ("fda") now requires that food products separately identify the amount of trans fat they con­ tain. 66 it is this labeling requirement, along with growing consumer demand for healthier products, that is prompting food manufacturers to seek alternatives to trans fat. another challenge faced by the health conscious consumer is labeling. labeling may be misleading. for example, foods labeled as "reduced sugar'' may not be lower in calories than those with higher sugar contents. consumers may also be confused, though perhaps not misled, if they fail to note the serving size when examining a product's nutritional information. worse yet, labeling may constitute a complete falsehood. a label may falsely indicate, for example, that a product is organic or kosher67 when in fact it is not label~ may also fail to make clear precisely what ingredients the product contains. ists called the "precautionary principle." sci. & envtl. health network, precautionary principle, www.sehn.org/precaution.html (last visited feb. 24, 2007). the science and environmental health network advocates for the use of the ''precautionary principle" in matters pertaining to environmental health, which essentially embraces the idea that it is better to be safe than sorry. ld thus, '"precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.'" id (quoting the wingspread statement on the precau­ tionary principle (jan. 1998)). applying the precautionary principle to the food industry argua­ bly would have prevented the original inclusion of trans fat, high fructose com syrup, and some chemicals from the food supply. 60 lappe & terry, supra note 33, at 36. 61 ld. 62 /d. 63 /d.; see also trans fats: the story behind the label, harv. pub. health rev., spring 2006, http://www .hsph.harvard.edu/review/rvw _ spring06/rvwspr06 _ transfats.html. 64 teicholz, supra note 39 ("[t]he only safe amount of trans fats in the diet is zero."). see also trans fats: the story behind the label, supra note 63 ("a healthy goal is to trim trans fat intake to less than 1 percent of total calories.''). 65 see lappe & terry, supra note 33, at 36. 66 nutrition labeling offood, 21 c.p.r. § 101.9(c)(ii)(2006)(effective jan. 1, 2006). see also laura e. derr, when food is poison: the history, consequences, and limitations of the food allergen labeling and consumer protection act of2004, 61 food & druo l.j. 65, 115 (2006) (noting that for individuals with food allergies, comprehensive labeling is critical). 67 see, e.g., joseph p. fried, state offers details online to help determine if food is truly kosher, n.y. times, feb. 27,2005, § 1, at38 (describing new york's law that requires those who produce, distribute, or sell kosher foods to register the source of certification to help determine whether kosher-labeled products are genuine). 68 a can of seagram's ginger ale, for example, states that it contains "high fructose com syrup and/or sucrose," making it impossible to know, in any given can, whether it contains one 2007] obesity, pubuc health, & food supply is fortunately, healthier food alternatives are being mainstreamed into the marketplace. as awareness of proper nutrition grows, consumers are demand­ ing a better quality food supply. 69 for example, it is more common today than it was twenty years ago to find a health food store in many communities. 70 in addition, larger chain stores like whole foods have expanded.71 recent im­ provements in traditional grocery store offerings are not to be overlooked. 72 some traditional grocery stores offer organic produce along with organic milk, cheese, and other dairy items. as consumers continue to demand healthy food choices and exercise their buying power accordingly, the availability ofhealth­ ier foods should also increase. 73 while these healthier food choices are an improvement, they do not go far enough. first, traditional grocery stores still have limited selections ofhealthy food choices and far too many unhealthy ones. second, the typical consumer or the other ingredient or some combination of the two. 69 see melanie warner, low carbs? who cares? sugar is latest supermarket demon, n.y. times, may 15, 2005, §i, at 1 [hereinafter warner, sugar is latest supermarket demon] (describing a survey conducted by the grocery manufacturers association in which "almost 50 percent of all grocery shoppers said they were looking for products with reduced sugar"). 70 see, e.g., organic consumers ass'n, whole foods killing off small natural food stores, http:/ /www.organicconsumers.orglorganic/whole _foods_ market.cfm (last visited feb. 24, 2007) (noting that despite the difficulties faced by small independent health food stores, such stores had grown by nearly twenty-five percent since 1998). 71 whole foods does not stock any product containing trans firt or artificial sweeteners. whole foods market, products, our quality standards, http://www.wholefoodsmarket .com/productslunacceptablefoodingredients.html {last visited mar. 2, 2007). moreover, it offers organic produce and meats that have not been fed hormones or antibiotics. whole foods mar­ ket, farm animal and meat quality standards program requirements, http://www .wholefoods market.com/products/meat-poultry/qs_programrequirets.html {last visited feb. 25, 2007). it does, however, offer foods high in sugar content and non-organic produce along with the or­ ganic options. see generally whole foods market, http://www.whole foodsmarket.com/products/index.html. trader joe's is another chain store that offers a range of organic food choices. trader joe's home page, http://www.traderjoes.com/product _categories.html (last visited feb. 25, 2007). many smaller health food stores stock only or­ ganic produce and :free-range meats that have no hormone or antibiotics. 72 see, e.g., the food emporium, good for you, http://www.thefoodemporium.com /good_for_you.asp (last visited feb. 25, 2007). the food emporium claims to be the "super­ market leader'' in organic and natural foods. /d. see also warner, sugar is latest supermarket . demon, supra note 69 ("[o]rganic and low or no sugar [products are] the two 'good ... ' food segments that will get products noticed by consumers and generate the strongest sales growth.''). as a result of this demand, 2,225 sugarless or reduced sugar products were introduced to the market in 2004. /d. 73 see food politics, the economist, dec. 7, 2006, available athttp://www.economist .com/world/intemationalldisplaystory.cfin?story _id=8380592. wai-mart recently announced that it would sell organic foods. see pallavi gogoi, wal-mart's organic offensive, bus. wk. online, mar. 29, 2006, http://www.businessweek.com/bwdaily/dnflashlmar2006/n:f20060329 _6971.htm (noting the concern that many organic farmers have over the possibility that wal­ mart's introduction into the organic food market will drive prices down to the point that it will be financially difficult for them.). 16 indiana health law review [vol. 4:1 must travel farther to shop at specialty stores. 74 third, the prices of healthier foods tend to be higher than those of standard grocery store fare. accordingly, for a vast sum of the populace, the reality is that the readily available, afford­ able food supply consists of the products available at a traditional grocery store along with fast food establishments. 75 moreover, not all of the grocery store products that appear to be healthy actually are. some of the new products are simply packaged to look healthier but are not necessarily healthier than the old products. for example, in the ef­ fort to satisfy consumer demand for products with less sugar,76 chemically­ sweetened substitutes that may be even more dangerous than sugar are some­ times used as alternatives. 77 a number of experts have voiced concern about the safety of these artificial sweeteners. 78 others have questioned whether the use of artificially sweetened foods actually helps in the effort to fight obesity. their concern is that it does nothing to eliminate sugar cravings. 79 thus, artifi74 in new york, where food choices of all varieties are plentiful, healthy alternatives have begun to crop up in neighborhoods that traditionally have been left out see florence fab­ ricant, more good eatingfor harlem, n.y. times. june 15, 2005, at f5 (noting the opening of a new health food store in harlem). 75 as noted above, this may change with wal-mart now in the organic food business. see supra note 73. 76 consumers spent one billion dollars on low sugar products in 2004. warner, sugar is latest supermarket demon, supra note 69. 77 /d. ("while many nutritionists champion artificial sweeteners as a way to cut calories and reduce sugar, others say these products are not the answer to america's weight and health problems. some critics voice concern about the increased consumption of what are essentially chemical sweeteners, especially among children."). 78 id. one physician notes that sucralose, one of the most popular sugar substitutes has been shown to cause minor genetic damages or mutagen in mice. jd this physician explains, "[t]he sucralose[,] people keep saying, 'it's just a little bit of a mutagen,' ...• 'well i don't want a little bit of a mutagen in my food supply. how do you know what happens in a long life span or to the next generation or to your eggs and sperm? i don't feel like the issues have been answered.'" /d. (quoting dr. susan schiffinan, a professor of medical psychology at duke uni­ versity medical center and sweetener specialist). for these reasons, whole foods and many other health food stores refuse to stock any product containing artificial sweeteners. see whole foods market, products, our quality standards, http://www.wholefoodsmarket.com /products/index.html (last visited feb. 25, 2007). 79 warner, sugar is latest supermarket demon, supra note 69 ("[ a]rtificial sweeteners do nothing for a person's 'overall health' because they perpetuate cravings for sweet foods.") (quoting dr. stuart fischer, a former specialist in low-carb diets who currently has a nutrition practice iti new york). yet another physician found that people who continue to eat artificially sweetened foods end up eating more foods with sugar than others. jd. (quoting dr. david katz, a professor of public health at the yale university school of medicine and a nutrition special­ ist). there is an argument on the other side, though, that the use of sugar substitutes does assist with weight loss, but only to the extent of no-calorie drinks. jd sugar free cookies, for exam­ ple, may have as many calories as the original product. id this is because more flour may be added to the product to add the bulk lost ftom removal of the sugar. id. thus, the caloric con­ tent may not be significantly different, and may even be worse, compared with the original sugar product. jd. 2007] obesity, pubuc health, & food supply 17 cially sweetened products raise overall health concerns about the chemicals that are replacing sugar and concerns about whether these products promote health­ ier eating habits and overall weight control. 80 obtaining healthy foods can be a challenge, particularly for those who live far from major metropolitan centers, those who have limited access to transpor­ tation, and for those who have a limited food budget, which is presumably most of the population.81 nonetheless, the causes of obesity are not limited to the food supply. they include the lack of adequate exercise, emotional overeating, genetics, and other environmental factors. even so, part of the solution for combating obesity will include addressing the food supply by creating easier and more affordable access to healthier foods. one ofthe likely obstacles to reforming america's weight problem is the food industry itself. the politics of food cannot be underestimated.82 for ex­ ample, farmers do not want to lose their corn subsidies, which keep the price of corn remarkably low.83 in tum, this arguably contributes to the use of high­ fructose corn syrup in many of our foods. 84 the food industry has also been proactive in its efforts to ensure that the tobacco litigation experience will not 80 one might argue that these products are misleading consumers into believing that they are healthy food choices and additionally, that they are appropriate ways to facilitate weight loss. a consumer, for example, might believe that reduced sugar cereals are lower in calories than those with a higher sugar content, when this is not necessarily the case. /d. q. stop label­ ing lies home page, www.stoplabelinglies.com (last visited feb. 25, 2007) (providing, among other things, infonnation to consumers on products that are falsely labeled); h. david gold, legal strategies to address the misrepresentation of vermont maple syrup, 59 food drug l.j. 93, 95-100 (2004) (focusing on misrepresentation on labels regarding the place of origin of foods). 81 the large and ever-growing income gap between the rich and poor and between the upper-class and middle-class leaves most of the wealth in this country in relatively few hands. the rest of the population, therefore, must spend carefully. john w. lee, iii, class warfare 1988-2005 over top individual income tax rates: teeter-totter from soak-the-rich to robin­ hood-in-reverse, 2 hastings bus. l.j. 47, 76 (2006) ("[t]he forgotten middle-classthose people who work hard and play by the rules[are taking] it on the chin."); bob herbert, work­ ing harder for the man, n.y.times, jan. 8, 2007, at ai9 (noting that while ordinary workers contributed to an eighteen percent increase in productivity between 2000 and 2006, their pay increased only one percent. while the pay of the super rich skyrocketed). 82 cf krugman, girth of a nation, supra note 14. while analogizing the obesity conflict to a red-blue political conflict, krugman notes, by comparing the much higher levels of obesity outside of metropolitan areas and in the south and midwest, that "[m]ore important, however, is the role of the food industry. the debate over obesity, it turns out, is a lot like the debate over global warming. in both cases, major companies protect their profits not only by lobbying against policies they don't like, but also by financing advocacy groups devoted to debunking research whose conclusions they don't like." id. see also nesti..e, supra note 34. 83 cf adam benforado, jon hanson & david yosifon, broken scales, obesity and justice in america, 53 emory l.j. 1645, 1792-94 (2004) (examining the government's failure to recognize the connection among com subsidies, high fructose com syrup, and obesity). 84 id. at i 794. 18 indiana health law review [vol. 4:1 be repeated in the food industr.y. 85 plaintiffs in the tobacco litigation sought to hold tobacco companies liable for illnesses associated with smoking, like lung cancer. 86 lobbying is taking place to urge states to enact laws that prevent law­ suits for personal injuries related to obesity. these "commonsense consump­ tion" laws would place accountability for obesity on the consumer, making it more difficult to sue food manufacturers. 87 a number of advocacy groups, in particular, the national restaurant association, have advocated for this legisla­ tion.88 the united states' food supply needs to be re-examined. while the cur­ rent trend shows an increase in healthier food alternatives, processed foods that are high in fat, sugar, and/or sodium still dominate the food supply. expanded consumer choice of healthy, affordable foods is critical. ill. food democracy "the fast food giants are becoming obsolete, and they know it. they're like angry, dying beasts lashing out. the twenty-first century doesn't belong to them. "89 since the food supply is a significant cause of the large scale obesity prob­ lem, what legal tools can be used to improve it? obesity has become a major public health problem only within the past fifty years. during this time, the food supply underwent a dramatic shift from locally grown whole foods to commercially produced processed foods.90 from a legal perspective, a number of strategies can be implemented to help improve the quality of the food supply. this article suggests a three-pronged approach to both improve the food sup­ ply and to begin to change the way society relates to food. first, the government can use its taxing power to tax unhealthy food choices. second, it can use its spending power to subsidize healthy choices. taxing and spending are public health law tools that have been used effectively 85 forest lee andrews, small bites: obesity lawsuits prepare to take on the fast food industry, is alb. l.j. sci.&teca153 (2004)(explainingwhylawsuitsdirectedatthefastfood industry may be justified). 86 courtney, supra note 30, at 84-91 (2006) (describing the history of tobacco litigation in the united states). 87 lorraine m. buerger, the safe games illinois act: can curbs on violent video games survive constitutional challenges?, 31 loy. u. chi. l.j. 617, 659-60 (2006)(focusing on the dangers of violent video games, the author also notes that video games may contribute to obesity and that the commonsense consumption laws' focus on individual responsibility makes legal recourse difficult). 88 jason a. smith, setting the stage for public health: the role of litigation in con­ trolling obesity, 28 u. ark. litilerockl. rev. 443,452-54 (2006) (arguing that individuals should be personally responsible for poor eating choices). 89 schlosser forward, supra note 33, .at xiv. 90 see generally supra text accompanying notes 33-66. 2007] obesity, pubuc health, & food supply 19 for more than a century to serve the public good. 91 together, they create mone­ tary incentives and disincentives that can profoundly impact public health. third, a bold offensive is needed to educate consumers and heighten their awareness not only of what to eat but how to eat. this educational and aware­ ness campaign needs to permeate popular culture so that we reach the point where there is widespread demand for healthier foods. a. taxing unhealthy foods taxing is a traditional public health tool that has been used in a variety of contexts to deter unhealthy behaviors and choices. 92 the imposition of signifi­ cant taxes on cigarettes, for example, is a result of efforts to reduce the number of smokers and presumably, the number of deaths due to lung cancer.93 taxes have also been imposed on firearms and alcoholic beverages.94 gambling, as­ serted by some as potentially addictive, is also subject to separate taxation. 95 while taxing may be used to deter behaviors, however, it may also be used to encourage certain positive behaviors through tax breaks and other fmancial in­ centives. for example, it has been used to encourage businesses to behave in environmentally responsible ways. 96 because the federal government's taxing authority is so broad, the range of tax incentives and disincentives is similarly broad.97 91 the federal government's power to tax is derived from the united states constitu­ tion, which provides that "congress shall have power to lay and collect taxes ... and provide for the common defence and general welfare of the united states." u.s. const. art. i,§ 8. cf. lawrence gostin, public health law: power, duty, reslraint 3-4 (university of califor­ nia press 2000). gostin summarizes the function of public health law as the use of"powers and duties of the state to assure the conditions for people to be healthy." id. at 4. 92 gostin, supra note 91, at 37. 93 id. 94 id. 95 id. 96 id. 97 ld. at 37-38. tax incentives, for example, have provided incentives for companies to build low-income housing. !d. at 37. additionally, non-profit organizations that are operated exclusively for charitable purposes are not taxed on their income and can receive donations that are tax-deductible for the donor. 26 u.s.c. § 50 i( c )(3) (2000). this enables nonprofits, some of which are engaged in public health activities, also to focus specifically on obesity. see, e.g., dr. susan love research found. home page, www.susanlovemd.org (last visited feb. 25, 2007) (researching women's health issues with a focus on breast cancer and menopause); the inst. for applied biomedicine home page, www.appliedbiomed.org (last visited feb. 25, 2007) (developing drugs to treat immune diseases including aids). see also am. obesity ass'n, about the aoa, http://www.obesity.org/subs/about.shtml (last visited feb. 25, 2007) (seeking to change public policy and perceptions surrounding obesity); obesityinamerica.org, support groups and patient advocacy organizations, http://www.obesityinamerica.org/support.html (last visited feb. 25, 2007) (advocating for obese individuals). 20 indiana heal til law review [vol. 4:1 the government's taxing power can be used to create healthier, affordable food choices. food constitutes a significant portion of the average american's budget. 98 therefore, it is probable that many individuals are sensitive to food prices. a tax on unhealthy foods will increase the price of those items, and if the prices become sufficiently high, consumers will likely shift to other alterna­ tives. one challenge will be to defme unhealthy foods. in other words, which foods will be subject to the "unhealthy food tax" ("uft")? all foods that con­ tain trans fat, for example, could be subject to the uft. since there is no safe level of trans fat consumption, taxing this ingredient would help reduce the de­ mand for products that contain it. a uft might also be imposed on foods that exceed a specified number of grams of salt, sugar, or fat per serving. 99 a uft could similarly be imposed for displaying unhealthy foods in places that are readily accessible to children under the age offive.100 likewise, it might apply to foods that exceed a certain caloric count per serving. in addition, the uft can be imposed on foods that might not qualify when looking at each of these factors individually but when combined exceed healthful limits. ufts could also be imposed on meat and poultry items unless the animals are grown without the use of antibiotics and growth honnones. similarly, fruits and vegetables that are grown with a certain level of pesticides might be subject to the uft. use of other chemicals may also warrant imposition of the uft.101 taxing unhealthy foods enhances the quality of the food supply in two ways. first, increased costs will decrease consumer demand. second, de­ creased consumer demand will give manufacturers an incentive to refonnulate products to make them healthier. taxes, then, can begin to alter the food land­ scape. b. using the spending power to subsidize healthy eating in addition to taxing unhealthy foods, the government can use its spending power to create a "health food subsidy" ("hfs") for healthy foods that it wants to promote. like taxing, government spending has been used in many contexts to promote public health.102 two of the largest publicly funded health care pro98 the average household spends almost fourteen percent of its budget on food. u.s. bureau of labor statistics, u.s. dep't of labor, consumer exi'endmjres in 2004, at 4 (2006), available at http://www.bls.gov/cexlcsxann04.pdf. 99 a serving size would have to be defined to reflect a normal serving size. 100 what parent has not felt frustration at the checkout counter of a grocery store or drug store where candy and gum are prominently displayed within reach of even· a two-year-old? 101 see, e.g., http://www.wholefoodsmarket.comlproductslunactablefoodingredients.html. among itsijloi'e than eighty unacceptable food ingredients are ammonium chloride, benzoyl peroxide, butylated hydroxytoluene (bht), msg, nitrates, nitrites, and saccharin. 102 "closely connected to the power to tax, the spending power has two purposes. first, it 2007] obesity, pubuc healm, & food supply 21 grams-medicare and medicaid-are examples of government spending to improve public health. 103 in addition, several state governments have also spent money on contraception devices, such as condoms, in an effort to stunt the spread of aids or other sexually transmitted diseases. 104 free, clean needles have also been purchased and given to intravenous drug users in order to pre­ vent drug addicts from sharing needles that could pass tainted blood from one addict to another. the list goes on.105 subsidies can also be used to promote a healthier food supply. just as pa­ rameters must be established to determine what foods to tax, parameters must also be established to classify those foods that should benefit from a hfs. for example, subsidizing organic farming could reduce or eliminate the price pre­ mium of organic foods. 106 instead of continuing with the controversial com subsidy, a hfs should be provided for organic farmers and for small local farmers. this would enhance the food supply and sustain local agriculture. these subsidies might then shift the way food is grown. for example, a hfs for organic farmers will make organic farming more feasible for a larger portion of the farming population. similarly, a hfs for local farmers will help sustain local agriculture that might otherwise disappear. overall, a hfs for locally grown and unprocessed nutritious foods will help sustain diversity in land use and contribute to a healthier food supply. 107 since we live in a society in which we eat out more than ever, consumers also need to have healthy choices when eating out. local governments, there­ fore, could offer another type of hfs. this type of hfs would encourage business establishments to provide healthy food choices.108 through reducing the price of healthy foods via a hfs regime, consumer demand for such foods will increase. when consumers purchase healthier foods overall public health will begin to improve.109 authorizes expenditures expressly for the public's health, safety, and well-being. secondly, it effectively induces state confonnance with federal regulatory standards." gostin, supra note 91, at 38. 103 jd. 104 !d. at 39. 105 jd. 106 in the news article "it's not easy being organic," a backyard gardener laments the difficulty and expense of trying to grow organic food and questions whether dousing produce with organically permitted chemicals is really preferable to using smaller quantities of other chemicals. william alexander, it's not easy being organic, n.y. times, may 27, 2006, at al3. 107 in addition to sustaining land use diversity, keeping local fanners in business also helps to maintain a more nutritious food supply. for example, a consumer in new york eating an apple from new zealand is likely to receive fewer nutrients from that apple than from a lo­ cally grown apple simply because nutrients will be lost in transit between the time the apple is picked in new zealand and the time it arrives on the shelf in new york. national public radio (may2006). 108 local governments could also encourage new businesses that promote healthy eating to settle within their jurisdictions. 109 another approach to the obesity problem would be for private parties to sue food 22 indiana realm law review [vol. 4:1 c. education and awareness of healthy food choices in addition to using government money via taxing and spending, private and public partnerships can be forged in which the private industry contributes, for example, to an educational and awareness program. the incentive is clear. when individuals understand more about healthy eating, and when healthy, affordable foods become as accessible as unhealthy ones, the level of obesity is more likely to decline. along with obesity, other diseases related to unhealthy eating habits, such as high blood pressure and heart disease are also likely to decrease. this is likely to help private industry in two ways. first, a healthier workforce will mean fewer days of absenteeism, and second, it may help tore­ duce corporate health care costs. for corporate america, then, investing in educational and awareness programs that promote healthy eating would be a companies for manufacturing and selling unhealthy foods. see generally alyse meislik, note, weighing in on the scales of justice: the obesity epidemic and litigation against the food industry, 46 ariz. l. rev. 781 (2004) (examining obesity legislation to date and exploring its chance of future success); courtney, supra note 30. this would embrace one tool used in the tobacco model and could, in the long run. have some success. it took many years, however, before plaintiffs prevailed in any of the tobacco cases. id at 84 ("[t]he first forty years of to­ bacco litigation resulted in a 'total lack of success' for plaintiffs."). while there were some later successes, courtney concludes that tobacco litigation has not been easy for plaintiffs or their lawyers. !d. at 90-91. there are significant differences between obesity and tobacco that could make obesity litigation even more difficult for plaintiffs than tobacco litigation. first, everyone needs to eat; smoking, however, is optional. tobacco companies were sued in part because they misrepresented the dangers associated with smoking and created the most addictive products they could. while some food labeling is arguably misleading, it is unclear whether the litigation model would be effective in the obesity context. perhaps it would be more effective to impose the uft on corporations like mcdonald's for marketing happy meals to young children. to the extent that public opinion is relevant, there is a greater sense that personal re­ sponsibility, rather than corporate liability, governs in obesity cases. when two mcdonald's consumers sued claiming that mcdonald's caused their obesity, see pelman v. mcdonald's corp., 237 f. supp. 2d 512, 516(s.d.n.y. 2003), many individuals were outraged, arguing that we are each responsible for what we choose to consume. cf. letters to the editor, fast food and obesity in america, n.y. times, july 7, 2005, at a22 (responding to krugman's news arti­ cle "girth of a nation," supra note 14). krugman wrote two editorials about obesity within a four day period. it was after the first one. "girth of a nation," in which he suggested that the obesity epidemic is caused in part by the food industry, that a number of readers expressed the opinion that the problem lies with the food choices of the individual consumer rather than with external forces. carl n. steeg, letter to the editor, fast food and obesity in america, n.y. times, july 7, 2005, at a22 {''controlling obesity is not the responsibility of the food indus­ try."); joseph kellard, letter to the editor, fast food and obesity in america, n.y. times, july 7, 2005, at a22 {"paul krugman ... should accept that people are responsible for their own eating habits."). see also krugman, free to choose obesity, supra note 13 (writing just four days after "girth of a nation," krugman attributes this attitude in part to the sophistication of the food industry in manipulating public opinion). another concern with a litigation model is that litigation often takes many years before the trial and appeals run their course. taxing, spending, and education, on the other hand, can be implemented fairly quickly if the political will is strong enough. 2007] obesity, pubuc health, & food supply 23 wise investment.110 hence, the third part of the proposal to combat obesity is to implement an extensive educational and awareness program about food and our relationship to it. 111 education and awareness programs, when done right, have proven very effective. for example, when health risks associated with smoking became a matter of common knowledge, societal thinking about smoking shifted. ciga­ rette smoking, which was once considered sophisticated, no longer is. instead, cigarette smokers are stigmatized rather than admired. 112 moreover, cigarette smoking is banned in airplanes, many restaurants and hotel rooms, and an in­ creasing number of office spaces. by further analogy, when it was first determined that the hiv virus that causes aids could spread through sexual intercourse or the exchange of bodily fluids, educational and awareness programs were successful in getting many individuals to use condoms.113 there were also successful programs aimed at getting intravenous drug users to use clean needles rather than sharing unsteril­ ized, used needles with other addicts.114 another example of the potential success of educational and awareness programs, and one more directly connected to food, relates to teaching diabetics how to manage their disease.m for example, an educational program at new york's beth israel medical center taught individuals with type 2 diabetes how to check their blood sugar levels, "count calories[,] and exercise with disci­ pline."116 the program folded a few years later, however, essentially because of its success. as diabetics in the program embraced healthier lifestyles, their need for care decreased. the program was the "victim[] of the byzantine world of american health care, in which the real profit is made not by controlling chronic diseases like diabetes but by treating their many complications. "117 the educational and awareness program related to food would, as noted 11° for a number of years, many corporations have built gyms for employees or subsi­ dized employee memberships in health clubs, recognizing that both employees and employers benefit from a healthy workforce. ill to the extent that spending on these programs is required, this is arguably another example of how government spending can be directed to help combat obesity and promote health. 112 cf. thank you for smoking (content film, room 9 entertainment, l.l.c. 2006) (illustrating a satire on this argument where a young boy whose father works for a tobacco cor­ pomtion grows to admire and want to be like him when he grows up). 113 linda c. fentiman, aids as a chronic illness: a cautionary tale for the end of the twentieth century, 61 alb. l. rev. 989, 995-96 (1998). perhaps the educational and awareness campaign surrounding aids needs to be revived. those who are just now becoming sexually active were not born when aids awareness was perhaps at its peak. tt4 id 115 ian urbina, in the treatment of diabetes. success often does not pay, n.y. times, jan. 11, 2006, at ai. tt6 id. 117 /d. 24 indiana healm law review [vol. 4:1 above, focus both on what to eat and how to eat with respect to what to eat, teaching children about the food pyramid on sporadic occasions in primary and secondary school is not sufficient instruction. food education should be ongo­ ing. instruction needs to encompass information about general food groups and the amount of each that should be consumed, as well as information about foods that should be avoided or consumed only in limited quantities. in addi­ tion, systemic enhancements in culinary education, such as training chefs to cook healthier foods, would gradually result in healthier foods in restaurants and other establishments. the educational and awareness plan should also encompass advertising restrictions similar to those applied to the tobacco industry. the same foods that would be subject to the uft discussed above, 118 for example, may be barred from television advertisements, especially those directed at children. movie advertisements should also change. coca-cola ads in theaters could be replaced with advertisements for healthy snack foods. advertisements can also target parents, who are perhaps in the best position to help overweight and obese children. just as there was once a commercial that reminded parents to be responsible for the whereabouts of their children, a similar commercial could remind parents to take responsibility for helping their children to eat health­ fully.u9 education and awareness can shift our entire relationship to and mentality about food. at some level, we need a cultural shift in the way we think about food. the increasing price of oil, some argue, is a major reason why we will begin to demand alternative energy sources. it is only when the price is too high that we will demand fuel-efficient cars, solar and wind power, ethanol, and the like. arguably, the food supply has already become unhealthy enough and over-processed to the point that consumers are beginning to demand better and healthier food choices. in other words, what one commentator describes as the "food democracy'' may be taking hold. 120 the food democracy movement "re­ ject[ s] the industrialized and degraded values of cheap food and replace[ s] them with concern for the needs of the people and the land, [and] with human fo­ cused values that weigh satisfaction and sustainability. "121 it also addresses the need for more information and the desire of eaters for "better tasting, fresher, 1 18 see supra part lila. 119 this author recalls a television commercial that would come on in the evening asking "it's 8:00p.m. do you know where your children are?" in the context of food, a similar com­ mercial might ask, "it's 10:00 p.m. do you know what your children ate today?" but see jodi kantor, as obesity fight hits cafeteria marry fear a note home from &hool, n.y. times, jan. 8, 2007, at a1 (noting anxiety provoked by providing a bmi report card to parents of school children). 120 neil hamilton, food democracy and the future of american values, 9 drake j. agric. l. 9, 9-16 (2004), subsequently published in neil hamilton, food democracy (2005). 121 id. at 16. 2007] obesity, pubuc heal til, & food supply 25 more wholesome and more nutritious food."122 1. the food democracy movement the growth of the food democracy movement is becoming more apparent everyday. the movement is fueling the growth of more organic foods, more stores that sell such foods, and more information about the food supply in gen­ era1.123 advancement is also demonstrated by the growing demand for healthier foods in schools and on many college campuses.124 corporate america has be­ gun to respond to these demands. for example, the top three soft drink compa­ nies, coca-cola, pepsi, and cadbury schweppes, recently announced that they will remove sweetened soft drinks from school cafeterias and vending ma­ chines.125 instead, only bottled water, 1 ooo/o fruit juice, and low-fat and nonfat milk will be available.126 while some suggest that this voluntary agreement was the result of the threat of litigation, it shows the companies' recognition that a shift in food mentality is well underway. the growing consumer demand for healthier foods has also been recog­ nized by others. for example, wal-mart has announced its intent to begin sell­ ing organic foods. 127 it is anticipated that wal-mart's introduction into the organic food market will lower the prices for organic foods. 128 in new york city two new outdoor, european style food markets that offer a diverse range of fresh foods opened in iune 2006.129 in addition, food manufacturers are mak­ ing efforts to make many of their existing products healthier, like looking for alternatives to trans fat. 13° consumer demand for healthier and more diverse 122 ld. 123 see supra notes 69-73 and accompanying text; infra notes 124-27. 124 yale univ., organic options growing across yale, http://www.yale.edu/ sustainability/foodproject.htm (last visited feb. 25, 2007) (describing use oflocally obtained organic foods for part of they ale university community); weena pun, no more frankenfruit: organic dining picks up at stanford, the stanford daily, may 4, 2006, http:l/daily.stanford.edu/article/2006/5/4/nomoref:rankenfruitorganicdiningpicksupatstanford (discussing stanford university's growing use of organic foods obtained from local sources); princeton univ., university health services, http://www.princeton.edu/uhslhi _ nutrition.html (last visited feb. 25, 2007). 125 marian burros & melanie wamer,bonlers agree to a school ban on sweet drinks, n.y. times, may 4, 2006, at ai. 126 id 127 melanie warner, wal-marteyes organicfoods,andbrandnamesgetinline, n.y. times, may 12, 2006, at fl. 128 id. 129 juliamoskin, farmers' markets go beyond green, n.y. timbs.may24, 2006. atal. in addition to offering organic foods, there will be a variety of food offerings, allowing the consumer to purchase everything he or she needs to prepare an evening meal. id 130 see generally wikipedia.org, trans fat, food industry response, http://en.wikipedia .org/wiki/trans_fat#food_ind.ustry_response (discussing efforts by kraft, kfc, mcdonald•s and other companies to find alternatives to trans &t); starbucks cuts use of trans fat, n.y. 26 indiana health law review [vol. 4:1 foods is therefore having a clear impact on the marketplace, the "human focused values"131 that are part of the food democracy move­ ment can also attempt to create a change in the way we, as a society think about food. the goal would be to change our entire relationship to food. americans, for example, are more likely than people in other cultures to eat on the run rather than to take the time to sit down and enjoy a meal. 132 when we eat on the run, our brains may not process the fact that we have had an eating experi­ ence. emotionally, we may feel like we have not really eaten at all. therefore, we are more likely to want to eat again, regardless ofhunger, in order to get that experience. 133 our lack ofbalance surrounding food arguably reflects our lack ofbalance in the way we live our lives more generally. recently, the journal of the american medical association ("jama'') reported that americans are much sicker than britains. 134 in explaining why he believes this may be so, new york times columnist and princeton professor paul krugman writes, [one] possibility is that americans work too hard and experience too much stress. full-time american work­ ers work, on average, about 46 weeks per year; full-time british, french and gennan workers work only 41 weeks a year .... [o]ur workaholic economy is actually more destructive of the "family values" we claim to honor.135 if we can restructure our days to fit time in to sit down and eat our meals slowly with greater awareness, we are more likely to pay better attention to what we eat. in this changed environment, we are more likely to eat less, enjoy our food more, and feel more content throughout the day. embracing the principles of food democracy will lead to a healthier, slimtimes, jan. 3, 2007, at c7 (discussing the reduction in the amount of trans fat in starbuck's doughnuts, muffins and other treats). of course, this effort is arguably because of consumer awareness about the dangers of trans fat and the increased refusal of customers to purchase foods that contain it. as the food industry begins to recognize that health and wealth are not mutually exclusive, and in fact are quite compatible when it comes to food offerings, better choices will begin to permeate society. local governments have also entered the food safety landscape. new york city, for example, now bans trans fat in restaurant food. see kim severson, go ahead, congress, pick at our dinner, n.y. times, dec. 31,2006, § 4, at 3. other cities are considering similar bans. id 131 see supra text accompanying note 121. 132 mireille guiliano, french women don't get fatthe secret of eating for pleasure 68 (2005) (comparing french and american eating habits to point out the "impor­ tance of not multitasking while you eat. j. 133 ld. 134 james banks et al., disease and disadvantage in the united states and in england, 295 j. am. med. ass'n 2037,2044 (2006). 135 paul krugman, op-ed., our sick society, n.y. times, may 5, 2006, at a23. 2007] obesity, pubuc realm, & food supply 27 mer society, including reduced levels of obesity because food democracy in­ cludes the ability to have greater, healthier, and affordable choices in the food supply. once individuals are empowered with these expanded and healthier choices, many will choose them. for now, though, mcdonald's, burger king, kfc, and similar fast food restaurants still permeate the american landscape. while healthier foods are also beginning to dot the scene, more intervention is necessary to improve the quality and affordability of the food supply on a broader scale. iv. conclusion the obesity epidemic is taking a toll on america. it results in hundreds of thousands of deaths each year, reduces life expectancy, and contributes to a host of health related ailments. in addition, obesity rates soared following un­ fortunate changes to the food supply, such as the increased use ofhigh :fructose com syrup. the three part approach of 1) taxing unhealthy foods, 2) increasing government spending for healthier foods, and 3) implementing a broad-based educational and awareness program can speed up the process by which we can begin to improve the health of our nation. under the influence: an examination of the tactics pharmaceutical companies use to manipulate physicians shena t. wheeler • i. introduction .................••.....••...•.•......•.....•••......•......•.....•.•............ 90 a. the issue .................................................................................... 90 b. roadmap .................................................................................... 93 ii. background: state and federal legislation limiting pharmaceutical company advertising expenditures and gifts to physicians from pharmaceutical companies ..•.••... 93 a. massachusetts: a total ban ...................................................... 93 b. minnesota: partial ban with recordkeeping requirements and several notable exceptions ....................................................... 95 c. new york: a proposal lawmakers can't refuse? ................... 97 d. vermont, west virginia, district of columbia, and maine: big brother is watching ................................................................... 98 e. proposed federal legislation: is it enough? ......................... ioo ill. background: american medical association standards for physician gifts, food & drug administration standards for advertising, and indiana state medical guidelines for born ................................................................... 101 a. american medical association standards ............................... 101 b. food and drug administration limitations: an historical perspective ............................................................................... 102 c. indiana state medical association compliance and guidance 103 n: analysis: do limits and bans on physician gifts and advertising help or hurt patients? ........................................ 103 a. what effect do gifts have on physicians' prescribing habits? ..................................................................................... 104 b. are pharmaceutical representatives qualified to educate doctors about new drugs? ..................................................... 106 c. economic concerns ................................................................. 107 d. does banning free drug samples hurt patients? .................. 109 e. ethical concerns ...................................................................... 111 g. first amendment issues ........................................................... 113 h. what is the best solution? ....................................................... 114 v. conclusion .................................................................................. 115 * j.d. candidate, 2010, indiana university school of lawindianapolis; b.s., 2005, central michigan university 90 indiana health law review [vol. 7:89 l introduction marie fishel has some deep regrets: while celebrating her twenty­ fifth wedding anniversary last night, she inhaled five plates of baby-back ribs at the local steakhouse's all-you-can-eat ribs monday. as a result, marie's persistent heartburn is flaring up again. in the past, over-the­ counter medications, such as prilosec, pepcid ac, and pepto bismol, have not relieved her symptoms. frustrated, marie made. an appointment with her family physician. as she swings her feet from the examination table in the doctor's office, internally rehearsing a list of her symptoms and their longevity for when the doctor shows up, she looks around the examination room, hoping to distract her mind from the painful burning in her esopha­ gus. prominently featured on the wall are posters of a human digestive tract, sponsored by nexium. bored with the graphic representation of her small intestine, she reaches for the remote control to the exam room's tiny television set. in between kathie lee gifford and hoda kotb's pleasantries about the latest thigh cream, she is bombarded with commercials for pre­ scription drugs. as the wait grows increasingly painful, she reaches for this week's people magazine, with a smiling patrick swayze on its cover. be­ tween gossip tidbits and human interest stories, marie notices glossy pages with columns in tiny typeface, touting the benefits and risks of everything from birth control pills to blood pressure medication. by the time the phy­ sician enters, carrying a cymbalta clipboard, with a menagerie of drug­ name inscribed ink pens in her lab coat pocket, marie cannot help but won­ der who is really prescribing her medication her physician or the pharma­ ceutical companies? · while marie's fictional situation has been embellished for dramatic effect, concerns about pharmaceutical companies' gifts to physicians and pharmaceutical advertisements are far from fictional and are creating quite a buzz in both the medical and legal professions. as lawmakers and industry watchdogs create new regulations in hopes of increasing pharmaceutical company accountability and decreasing prescription drug costs, there is an increasing need to examine the risks and benefits of such regulations. a. thelssue pharmaceutical companies strive to create and maintain relationships with physicians through advertising and gift-giving, in hopes of influencing them to prescribe their drugs more frequently than their competitors.1 ac­ cording to a survey published in the new england journal of medicine in 2007, 94% of physicians reported having arelationship with pharmaceutical 1. eric g. campbell et · al., a national survey of physician-industry relationships, 356 new eng. j. med. 1742, 1743 (2007). 2010] under the influence 91 companies.2 of those physicians, 83% claimed that those relationships in­ volved free meals, while 78% of those physicians received free drug sam­ ples. 3 other types of gifts include trinkets, honors for . speaking engagements, reimbursement of travel expenses, and free admission to en­ tertainment events or medical conferences.4 recently, several states have proposed {)f adopted total or partial bat1s on gifts made by pharmaceutical companies to physicians.5 most of these statutes include disclosure requirements for advertising expenditures made by pharmaceutical companies.6 although the definition varies state-by­ state, advertising expenditures typically include gifts given· over a certain dollar threshold made to physicians.7 legislation has also been introduced in the united states ·congress which would require pharmaceutical compa­ nies to report all ''payment[s} or transfer[s] of value" made to physicians.8 medical schools across the country have also adopted this trend, restricting gifts made by pharmaceutical companies to their students.9 in addition, the pharmaceutical research and manufacturers ofamer­ ica (phrma) recently released voluntary guidelines prohibiting pharma­ ceutical . companies from offering physicians trinkets such as pens, notepads, and. calendars emblazoned with a drug name.10 under these guidelines, small gifts lacking any educational purpose and· that-are valued under $100 are prohibited.11 . . both physicians and patients can be affected by drug advertisements· paid for by pharmaceutical companies.12 pharmaceutical companies spend nearly twice as much on advertising and marketing as on pharmaceutical 2. /d. at 1742. 3. /d 4. /d. at 1743. 5. vt. stat. ann. tit. 18, § 4632 (2008); minn. stat. ann.§ 151.461 (west 2008). 6. id. 7. id 8. physician payments sunshine act of2007, s.2029, lloth cong. (2007). 9. for example, the university of pennsylvania, stanford university, yale universi­ ty, and the university of maryland medical schools all prohibit phannaceutical company gift-giving on their campuses. johns hopkins university school of medicine was consider­ ing a ban as recently as march 2009. the university of minnesota is considering a "con­ flict-of-interest policy" that would have effects similar to that of a gift ban. see generally, julekha dash, johns hopkins university eyeing ban on drug lm:fustry 's free pens, food, and fun, boston bus. j., mar. 6, 2009, available at http://bqstoo.b~oumals.comlboston/ othercities/baltimore/stories/2009103/09/story3.h1ml?b=1236571200%5el789736; janet moore, u medical school plan: ban all gifts to doctors, star trib.-oct. 21, 2008, available at http:/lwww.startribune.com/lifestylelhealth/31435329.html?c;lr=karkslckd8eqduoaeyqy p40:dw3ckuid3apc:yyc:auuj. . 10. mary ellen schneider, voluntary phrma guidelines will ban trinkets, entrepreneur, (october 2008), htlp:/lwww.entrepreneur.com/tradejoumals/article/18894 3082.h1ml. 11. id 12. matthew arnold, consumer ads influence doctors: study, med. marketing & media, (june 2005), http://findarticles.oonilp/articles/mi _ qa5351/is _200506/ai _ n21373090. 92 indiana health law review [vol. 7:89 research and development; this includes the aforementioned gifts and free samples, as well as advertisements pe8pering primetime television and four-page spreads in glossy magazines. 3 there is evidence that patient­ directed advertisements impact physicians as wel1.14 one study found that doctors are discussing advertisements with their patients more than ever before.15 that same study found that physicians mention these ads to their patients just as often as their patients ask their doctors about the ads. 16 when pharmaceutical advertising began, it was directed solely at prescrib­ ing physicians; advertisements were directed to consumer-patients for the first time in 1981.17 since then, there has been an influx of consumer­ patient-directed pharmaceutical advertisements on television, on the radio, and in magazines. this is important because although the target audience for these ads consists of consumer-patients, physicians will inevitably be exposed to them as well, which will likely influence their prescribing ha­ bits. in indiana, a state which serves as home to many pharmaceutical companies, 18 there has been some progress in this area of the law. after being the first pharmaceutical company in the nation to endorse the physi­ cian payments sunshine act (ppsa), 19 eli lilly and company ~lans to launch an online registry of its payments to physicians in 2009. 0 lilly would create a database accessible to the public via the internet, which, by 2011, would include all payments made to physicians, and payments made for speaking engagements, bringing it into anticipatory compliance with the ppsa, should it be passed by congress?1 despite lilly's voluntary antic­ ipatory compliance with the ppsa, it is not currently held to any state re­ quirements: the indiana state legislature, unlike some other states, has yet 13. york university, big pharma spends more on advertising than research and development, study finds, sci. daily (jan. 7, 2008), http://www.sciencedaily.com/releases/ 2008/01/080 l 05140107 .htm. 14. arnold, supra note 12. 15. id 16. id 17. francis b. palumbo, and c. daniel mullins, the development of direct-to­ consumer prescription drug advertising regulation, 57 fooo & drug l.j. 423, 424 (2002). 18. indiana's pharmaceutical companies include, but are not limited to, bayer, bristol mayer squibb, eli lilly & co., covance, pfizer, and schwarz pharma. pharmaceutical companies in indiana, http://www.purdue.edu/dp/ptec/companies.pdf. 19. the physician payments sunshine act, so named because of its intention to shed light on payments from pharmaceutical companies to physicians, is proposed federal legisla­ tion. if passed, it would require pharmaceutical companies to issue quarterly reports for most categories of physician gifts. it does not, however, purport to ban physician gifts alto­ gether. physician payments sunshine act of2007, s.2029, llotb cong. (2007). 20. erik greb, lilly to establish registry of its payments to physicians, the electronic newsl. of pharmaceutical tech. (oct. 2, 2008), http:// pbarm­ tech.findpharma.com/pharmtecb/manufacturing!lilly-to-establish-registry-of-its-payments-to­ phy/ articlestandardl article/detail/55570 i ?contextcategoryid=40939&ref-=25. 21. id. 2010] under the influence 93 to introduce legislation banning or partially banning gifts to physicians. b. roadmap this note discusses external factors influencing physicians' prescrib­ ing habits, including gifts from pharmaceutical companies and drug adver­ tisements, and the current and pending state and federal regulations designed to curb such practices. in order to foster an understanding of the current legislation, section ii provides a historical background of several state statutes and federal legislation regulating physician gifts, including motivation and criticisms of each. section iii offers historical background of drug advertising regulations nationwide, with a special focus on such regulations in indiana. section iv discusses whether current and pending bans on physician gifts help or hurt consumer-patients and contains an analysis of gifts from pharmaceutical companies and drug advertising in light of the current economic crisis and the state of america's health care system. finally, section v concludes the discussion with the suggestion that achieving a balance between accurate dissemination of information about new drugs and therapies and limits on undue influence from pharma­ ceutical companies may be the best way to resolve the issue. ii. background: state and federal legislation limiting pharmaceutical company advertising expenditures and gifts to physicians from pharmaceutical companies in order to facilitate a better understanding of the necessity of state and federal legislation regulating physician gifts, a discussion of the current and pending state and federal legislation is imperative. the state statutes can be placed into three broad categories: 1) total bans on physician gifts; 2) partial bans on physician gifts; and 3) required recordkeeping of all ad­ vertising costs, including physician gifts, with disclosure to the state gov­ ernment. a. massachusetts: a total ban massachusetts is the only state thus far to prohibit all gifts made by pharmaceutical companies to physicians.22 the ban, introduced by senate president therese murray in march 2008, is the first of its kind in the unit­ ed states.z3 it allows for fines of up to $5,000 for a single infraction?4 22. mass. gen. laws ann. ch. llln, § 2 (west 2008). 23. megan woolhouse, ban on gifts to doctors sought, boston globe, mar. 4, 2008, available at http://www.boston.com/newslhealth/articles/2008/03/04/ban _on _gifts_ to _doctors_ sought! 24. ld. 94 indiana health law review [vol. 7:89 touted as an "act to promote cost containment, transparency and effi­ ciency in the delivery of quality health care;.25 the massachusetts statute was passed in august 2008 and became effective on january 1, 2009.26 it requires the massachusetts department of health to ''adopt a standard mar­ keting code of conduct for all pharmaceutical or medical device manufac­ turing companies that employ a person to sell or market prescription drugs or medical devices in the commonwealth.'.27 in turn, the new code created by the department of health must, by law, prohibit meals bought for physi­ cians by pharmaceutical companies for entertainment, absent informational presentations, outside the physician's office, or for the physician's spouse.28 in addition, it must prohibits gifts of tickets for sporting events or leisure activities; reimbursement for travel expenses; compensation for a physi­ cian's participation in a continuing medical education (cme) presentation; meals at conferences; cash payments, unless for services; and grants or scholarships related to the prescription drug_29 however, the new code al­ lows for an exchange of academic or scientific information; purchase of ad space in academic journals; drug samples; payment for participation in clin­ ical trials; and reimbursement for expenses relating to technical training on use of a medical device.30 these specific prohibitions and requirements demonstrate the state's balancing act: outlaw unnecessary and frivolous gifts. and payments to physicians while fostering the need to disseminate information related to new drugs and therapies. the massachusetts statute allows a pharmaceutical company to educate physicians on its new drug innovations, but draws the line at social means and compensation for atten­ dance at various cme events. critics of the ban cite concerns about disrupting the free flow of drug information between drug companies, physicians, and patients. they assert that pharmaceutical company representatives are experts regarding the drugs they sell. 31 although there are concerns that physician gifts raise pre­ scription· drug costs, at least one critic of the massachusetts statute, julie corcoran, deputy vice president of phrma, says there is no evidence to support such a·contention.32 other critics of the massachusetts statute have expressed concern that the ban will suppress drug innovation and investment in the state.33 eli lil25. massachusetts s.b. no. 2863 (mass. 2008). 26. mass. gen. laws ann. ch. llln, § 2 (2008). 27. !d. 28. id 29. id 30. ld 31. woolhouse, supra note 23. 32. id 33. mark hollmer, eli lilly ceo says gifts ban could drive drug research from massachusetts, boston bus. j.,sept. 19, 2008, available at http://www.bizjoumals.com/ boston!stories/2008/09/15/daily78.html (last visited jul. 8, 2009). 2010] under the influence 95 ly president and ceo john lechleiter noted the ban has "the potential not only to stifle clinical research in massachusetts, but also to complicate a key part of market access: the ability to share information.',34 lechleiter fears the law will "subject doctors, hospitals and academic institutions to complex financial disclosure requirements about payments for clinical re­ search.',35 these rising administrative costs may even parlay into increased prescription drug costs. thomas sullivan, president of a medical communi­ cations company, argued that the ban would have ''devastating effects on the research institutions that make boston the largest healthcare economy in the country. "36 sullivan estimates that the ban "could disqualify as many as 20% of our faculty, as the ban covers all honorarium and travel ... we would have no way to pay speakers from massachusetts to travel to events, and no way to pay them for their time. "37 however, the ban has not been in effect long enough to determine the legitimacy of these concerns. b. minnesota: partial ban with recordkeeping requirements and several notable exceptions minnesota legislators passed a partial ban on physician gifts in 2008.38 in minnesota, pharmaceutical companies are prohibited from giving any gifts to any physician with a "combined retail value" exceeding $50, subject to a few exceptions?9 the exceptions include: drug samples; compensation to sponsor medical conferences, as long as the compensation is not paid to the physician and the conference is for educational purposes only; consult­ ing fees for research projects; publications; employee salaries; and "reason­ able honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting.'.4° however, public availability to such information is limited. public accessibility is provided, but practically speaking, it is very difficult to ob­ tain any of the disclosure reports.41 the disclosure fonns are unavailable electronically or online .. 42 the only way for an individual to obtain the fonns is to "travel to the state office in minnesota in order to photocopy 34. !d. 35. id 36. ben comer, state senate approves ban on gifts to physicians, med. marketing & media (apr. 21, 2008), available at http://www.mmm-online.com/state-senate-approves­ ban-on-gifts-to-physicians/articlell 09220/. 37. !d. 38. minn. stat. ann. § 151.461 (2008). 39. !d. 40. !d. 41. robert kirby, karl h. buch. & phoebe a. wilkinson, n.y. seeks to join states regulating pay to physicians, 0urside couns., 240 n.y.l.j. 4, 4 (2008). 42. !d. 96 indiana health law review [vol. 7:89 each form at a fee of$0.25 per copy.',43 this restricts public availability to those unable to travel to the state office; public access is therefore some­ what illusory. dr. carl heltne, chief medical officer for smdc health system of duluth, minnesota, a nonprofit health care system of over twenty clinics and hospitals, supports the ban because he feels it stifles misconceptions about the medical industry: "no matter how you look at it, we [are] all in­ fluenced by these marketing activities ... [b ]ut patients come to us and they trust us to make decisions solely on their behalf. to uphold that trust, we can[not] have even a perception that companies influence us.'m minneso­ ta 's ban on pharmaceutical companies' gifts of free food for physicians was the first of its kind.45 interestingly, after the ban went into effect, pharma­ ceutical companies began inviting nurses and secretaries to informational dinners, despite the fact that nurses and secretaries lack prescription au­ thority.46 however, the real targets of the pharmaceutical company's mar­ keting blitz are the speakers at the dinners, physicians who require training about the company's drug prior to eaeh speaking engagement.~7 the doc­ tors are often paid handsomely for these presentations, some fetching up to $100,000 per year.48 however, most claim to be immune from the influ­ ence of compensation they earn from the presentations.49 after watchdog groups first raised awareness about the minnesota law in 2007, pharmaceutical companies began spending less on minnesota doc­ tors. 5° from 2007 to 2008, pharmaceutical company payments to doctors dropped by over $3.5 million.51 this drop could be attributed to the in­ creasing transparency of pharmaceutical company ~ayments to physicians, but it could also be a result of a suffering economy. 2 while the reason for the decline is unclear, others suggest that increasing concern over the con­ flict of interest between pharmaceutical companies and doctors is a plausi­ ble explanation. 53 43. /d. (citing joseph s. ross et al., pharmaceutical company payments to physi­ cians: early experiences with disclosure laws in vermont and minnesota, 297 jama 1216, 1218 (2007)). 44. gardiner harris, minnesota limits on gifts to doctors may catch on, n. y. times, oct. 12, 2007, available at http://www.nytimes.com/2007/10/12/us/l2gift.html. 45. /d. 46. /d. 47. id 48. id 49. id. 50. jeremy olson, pharmaceutical companies spending less on minnesota doctors, the pioneer press, jul. 6, 2009, available at ht1p:l/www.twincities.com/ci_l2573822 ?nclick_ check= l. 51. id. 52. /d. 53. id. 2010] under tiie influence 97 c. new york: a proposal lawmakers can't refuse? in 2008, a statute that would partially limit gifts to physicians was in­ troduced in the new york assembly. the new york assembly bill cited compelling evidence that the vast majority of physi­ cians accept some type of gift or payment from phar­ maceutical and medical device manufacturers, and often such gifts and payments, even when of little value, influence physicians to prescribe treatments that are more expensive and no more effective or safe, and are sometimes less effective and more dangerous, than other available treatments. 54 the new york assembly also found that "[l]egislation is necessary to pro­ hibit presenters at continuing professional education programs from provid­ ing false or misleading information to prescribers and to require all potential conflicts of interest be disclosed to attendees of such programs. ,,ss the proposed legislation would prohibit all gifts aggregating to more than $50 annually to physicians and medical students, with exceptions: drug samples; payment for clinical trials; manufacturer's discounts for drugs or medical devices; and "anything of economic value given by a person with a financial relationship with a manufacturer who is related by blood, marriage or adoption within three degrees of consanguinity to the recipient prescrib­ er."56 the proposed new york legislation differs from the minnesota sta­ tute because it applies to both physician gifts and to gifts made to medical students.57 the permissible exceptions also differ: for example, the min­ nesota statute provides exceptions for publications and employee salaries, while the proposed new york statute does not. 58 these small differences in state-by-state legislation may provide a better framework for possible fed­ eral legislation banning physician gifts, since they permit lawmakers, phar­ maceutical companies, and physicians to see what works and what does not. a federal model would likely take these findings into consideration. the proposed new york lefslation also requires yearly disclosure of any benefits given or received.5 the disclosure is mandatory when the physician or medical student "offered, gave, or received a benefit," the pharmaceutical company gave the physician a discount, or there was "a fi54. /d. 55. /d. 56. s. 6015, 64th gen. assem., 23lst sess. (n.y. 2009). 57. /d. 58. compare minn. stat. ann.§ 151.461 (2008) with s. 6015, #gen. assem., 23lst sess. (n.y. 2009). 59. s. 6015, 64th gen. assem., 231st sess. (n.y. 2009). 98 indiana health law review [vol. 7:89 nancial relationship" between the pharmaceutical company and the physi­ cian or medical student.60 if one of these factors is met, a disclosure must be made in one of three categories: disclosure of a benefit; disclosure of a discount, or disclosure of a financial relationship.61 violation ofthe par­ tial gift ban or failure to comply with the disclosure requirements could re­ sult in a fine of $5,000-$50,000 for pharmaceutical companies, or $5,000$10,000 for physicians.62 d. vermont, west virginia, district of columbia, and maine: big brother is watching the least restrictive state statutes require disclosure of physician gifts. in 2008, vermont legislators passed an initiative . requiring disclosure of marketing expenditures, including physician gifts.63 the vermont statute requires pharmaceutical companies to record gifts made to physicians if the value of the particular gift exceeds $25, subject to a civil penalty of up to $10,000 for failure to disclose.64 along with gifts under $25, drug samples, scholarships to medical students, and drug rebates are also exempt. 65 after reports are made to the attorney general, the disclosures are then reported to state lawmakers and the governor.66 another important exemption from such reports is any statement which would disclose a pharmaceutical com­ pany's trade secrets.67 as a result, "61 percent of payments to physicians that had been disclosed under the vermont law were designated 'trade se­ crets' by the reporting manufacturer, and were therefore kept confidential from the public."68 west virginia also requires disclosure of marketing expenditures as­ sociated with prescription drugs, excluding drug samples, reimbursement for costs associated with clinical trials, and scholarships for medical stu­ dents. 69 as the least restrictive state statute for pharmaceutical companies, west virginia's statute does not apply to medical device manufacturers.70 the disclosure information is not available to the public: "any 'national aggregate expense [information]' disclosed to state officials is considered 60. ld. "financial relationship" is defined by the proposed statute as "an ownership interest, investment interest, or compensation arrangement." 61. id. 62. ld. 63. vt. stat. ann. tit. 18, § 4632 (2008). 64. id. 65. !d. 66. !d. 67. kirby, supra note 41. 68. !d. (citing joseph s. ross et al., pharmaceutical company payments to physi­ cians: early experiences with disclosure laws in vermont and minnesota, 297 jama 1216, 1218 (2007}). 69. w.va. code§ 5a-3c-13 (2008). 70. kirby, supra note 41. 2010] under the influence 99 confidential and is not subject to release under west virginia's freedom of information act."71 in addition, the west virginia statute does not incen­ tivize pharmaceutical companies to comply with the law because there are no penalties levied for failure to do so. 72 critics of the west virginia statute, including some pharmaceutical companies, allege that. it may violate the first amendment of the united states constitution; since the "communication [is] made for the sole pur­ pose of selling products or services," the speech should be protected under the commercial speech doctrine?3 it may also be seen as a violation of free speech because the information, released in aggregate, may reflect poorly upon a pharmaceutical company and "discourage the public" from purchas­ ing its products. 74 the district of columbia's statute simply requires a reporting of all advertising costs made by pharmaceutical companies?5 legislation in maine,.however, is considerably more complicated. the maine statute re­ quires "manufacturers or labelers" of prescription drugs to report their ad­ vertising expenses annually.76 advertising expenses include direct expenditures for television, radio, and print ads, gifts to physicians over $25 in value, and travel expenses. it also includes drug samples, if those sam­ ples will not be given to patients for free.77 exclusions include expenses of $25 or less; "reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy or treat­ ment," and educational scholarships.78 the statute's stated purpose is to "enabl[ e] [maine]·· to determine the scope of prescription drug marketing costs and their effect on the cost, utilization and delivery of health care ser­ vices and further[ ] · the role of this state as guardian of the public interest."79. . a similar maine statute was challenged in ims health corp. v. rowe. 80 prescription drug iilformation intermediaries (pdlls) intercept valuable information regarding pharmaceutical companies, physicians, and patients, including prescribing pattern information. they later sell such information back to pharmaceutical companies, who in turn use it to ad­ vance their market research practices.81 the court weighed several advan71. !d. 72. !d. 73. brienne taylor greiner, a tough pill to swallow: does the first amendment prohibit wv from regulating pharmaceutical companies ' advertising expenses to lower the cost of prescription drugs? 109 w.va. l. rev. 107, 119-20 (2006). 74. !d. 75. d.c. code § 48-833.01 (2008). 76. me. rev. stat. ann. tit 22,. § 2698-a (2008). 77. jd. 78. jd 79. !d. 80. ims health corp. v. rowe, 532 f.supp.2d 153, 154 (d. me. 2007). 81. !d. at 158. 100 indiana health law review [vol. 7:89 tages and disadvantages of such pdiis, including cost, efficiency, and vacy. the court also noted the widespread use of questionable sales me­ thods and pharmaceutical industry misconduct. 82 ims challenged the con­ constitutionality of 22 m.r.s.a. §§ 1711-e, which "restrict[ ed] the use of prescriber identifying information" in an effort to "decrease drug detailing that targets the prescriber, thus increasing decisions to prescribe lower priced drugs and decisions made on the basis of medical and scientific knowledge and driving down the cost ofhealth care."83 the state also ar­ gued that 22 m.r.s.a. § 1711-e would enhance the effectiveness of other laws, including mrsa § 2698-a; the court held that this was a legitimate governmental interest. 84 despite the legitimacy of this interest, the court held "that the provisions of the maine law that seek to restrict the use and disclosure of commercial information violate the free speech guarantee of the first amendment. "85 e. proposed federal legislation: is it enough? the united states congress has addressed the issue of pharmaceutical company gifts to physicians with the physician payment sunshine act of 2007 (ppsa), so named because it is intended to shed light on the relation­ ship between the pharmaceutical industry and physicians. 86 the ppsa was introduced in the senate in september 2007; a similar bill was introduced in the house in march 2008.87 the sponsors of the ppsa intended that it would yield "'transparency' to such payments and ... 'foster accountability by empowering consumers and other watchdogs."'88 the ppsa primarily addresses means of disclosure, rather than outright limits or bans on physi­ cian gifts.89 ppsa requires quarterly reports by "manufacturers of covered drugs, devices, or medical supplies under medicare, medicaid, or schip [state children's health insurance program]."90 the reports required by the ppsa must include physician's name, ad­ dress, and facility with which the physician is associated, as well as the amount, date, and description of the payment.91 the description can fall into one of eight categories, including: compensation; food, entertainment, or gifts; trips or 82. !d. at 160-66. 83. !d. at 160 (quoting me. rev. stat. an~i. tit. 22 § 17ll-e)(2008)). 84. ims health corp., 532 f.supp. 2d at 175. 85. !d. at 182. 86. kirby, supra note 41. 87. !d. 88. /d. 89. physician payments sunshine act of2007, s.2029, i loth cong. (2007). 90. !d. 91. !d. 2010] underthelnfluence travel; a product or other item provided for less than market value; participation in a medical conference, continuing medical education, or other educational or informational program or seminar, provision of mate­ rials related to such a conference or educational or in­ formational program or seminar, or remuneration for promoting or participating in such a conference or educational or informational program or seminar; product rebates or discounts; consulting fees or hono­ raria; or an1 other economic benefit, as defined by the secretary. 9 101 if the federal legislation is passed, it will preempt existing pharmaceutical industry disclosure laws in many states, which will eliminate inconsistency in this area of the law.93•94 iii. background: american medical association standards for physician gifts, food & drug administration standards for advertising, and indiana state medical guidelines for both a. american medical association standards in the early 1990s, the american medical association (ama) devel­ oped its own standards to address the issue of physician gifts.95 the ama opinion states that gifts should only be accepted when they benefit a patient and are not too lavish.96 certain gifts may be appropriate if they serve an informational purpose, including meals or textbooks.97 in addition, "[i]ndividual gifts of minimal value are permissible as lon~ as the gifts are related to the physician's work (e.g., pens and notepads)." 8 according to the ama opinion, subsidies from the industry should not be accepted di­ rectly or indirectly to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should sub92. id. 93. kirby, supra note 41. 94. in early 2009, the ppsa was reintroduced in the senate, with some amendments. maribel rios, physician payments sunshine act reintroduced for 2009 (jan. 29, 2009), available at http://pharmtech.findpharma.com/pharmtech!news/physician-payments­ sunshine-act-reintroduced-for 2/ articlestandard/ article/detailf577973?contextcategoryld =35097. 95. american medical association, opinion 8. 061gifts to physicians from the indus­ try, adopted december 1990, http://www.ama-assn.org/ama!pub/category/400l.html (last visited jul. 9, 2009). 96. !d. 97. id. 98. /d. 102 indiana health law review [vol. 7:89 sidies be accepted to compensate for the physicians' time.99 finally, [n]o gifts should be accepted if there are strings at­ tached.100 for example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. in addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the se­ lection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.101 · b. food and drug administration limitations: an historical perspective the food & drug administration (fda) has also imposed advertising limitations on pharmaceutical companies. first regulated by the fda, then the federal trade commission, now fda again, spending on direct-to­ consumer (dtc} advertising rose from just $12 million in 1989 to over $2.3 billion in 2001. 02 the federal food, drug, and cosmetic act of 1938 (fdca) contains one provision for pharmaceutical advertisements, which "requires simply that the advertisement include the drug's generic name and formula, and a brief summary describing the effectiveness of the drug and its risks."103 this "brief summary" must include drug side effects and warnings.104 "second, the "fair balance doctrine" provides that the entire advertisement must present a balanced account of all clinically relevant in­ formation; the risks must be presented grominently and legibly so that the benefits are not unfairly emphasized."1 5 balancing information must be prominently mentioned in the ad so that patient-consumers can properly weigh the pros and cons of taking the drug.106 the advertising cannot be false or misleading and should be consistent with the drug's label.107 in addition, the fda has created three "categories of prescription drug advertisements ... : 1) reminder advertisements, 2) help-seeking or disease­ oriented advertisements, and 3) product-claim or indication advertise­ ments."108 reminder advertisements show the drug name but do not pro­ vide information about the drug itself, such as pens, post-its, desk 99. /d 100. id 101. id. 102. palumbo, supra note 17, at 423-24. 103. id at 428. 104. id 105. id. 106. jd 107. /d 108. palumbo, supra note 17, at 428. 2010] underthe!nfluence 103 calendars, or coffee mugs imprinted with a drug's name!09 help-seeking or "see your doctor" advertisements are the opposite: they "typically de.; scribe the symptoms of a disease or condition, and encourage consumers to consult their ph6sician to discuss treatment options, but do not mention the drug's name."ll since neither reminder advertisements nor help-seeking advertisements show consumers the effectiveness of a particular drug, the brief summary and fair balance requirements are inapplicable.111 product-claim advertisements are a combination of the previous two types of advertisements, meaning they present the drug's name as a drug for certain medical symptoms.112 because of this, product claim advertise­ ments "must satisfy the brief summary requirements and maintain fair bal­ ance."113 in 1999, the fda decided that television advertisements must contain a "disclos[ure of] the product's major risks," which is presumably why the phrase, "if you experience an erection lasting more than four hours," has become part of the american lexicon.114 an ad must now include a toll­ free phone number that consumers may call to receive more information; offer of further information in another medium ("see our ad in soap opera digest"); a web address that has drug label information; and that consumer­ patients may consult their physicians for more information.115 c. indiana state medical association compliance and guidance in indiana, although gifts from the industry are not addressed by indi­ ana law, the indiana state medical association defers to the ama ethical standards in this area.116 iv: analysis: do limits and bans on physician gifts and advertising help or hurt patients? the arguments on both sides of this compelling issue are comparably persuasive. on one hand, those opposing physician gift limits and bans consider industry guidelines sufficient to curb any inappropriate conduct by both pharmaceutical companies and physicians. in addition, some physi­ cians are offended by the implication perpetuated by gift limits and bans that they are not prescribing drugs according to their patients' needs and 109. id 110. /d. ill. id. at 428-29. 112. /d. 113. /d. 114. palumbo, supra note 17, at 431. 115. id. 116. indiana state medical association, legal resources: compliance and guidance documents, available at http://www.ismanet.org/legal/compliance _ docs.htm. 104 indiana health law review [vol. 7:89 abhor the thought of further regulations that some fear could inhibit the free flow of information about new drugs. in contrast, proponents of limits and bans on physician gifts cite ethi­ cal concerns and higher prescription drug costs as their primary criticisms of such gifts. this anti-pharm hysteria is widespread: websites such as pharmedout.org and nofreelunch.org condemn the use of pharmaceutical company freebies to influence physicians' prescribing habits. a recent sur­ vey of patient-consumers revealed that many were opposed to pharmaceuti­ cal company gifts to physicians. 117 over 80% of respondents said that pharmaceutical companies should be prohibited from gifting physicians with free dinners and travel. 118 in addition, over half of those surveyed thought that drug sam~les from pharmaceutical companies to physicians should be prohibited.11 perhaps even more telling is that nearly 70% of respondents would support legislation requiring gift disclosure. 120 the major concerns about the practice of pharmaceutical companies' gifts to physicians were enumerated by dr. ogan gurel: unsustainable high cost (hence the massive layoffs that pfizer announced in 2007)[;] [ c ]oncerns that marketing costs add to the cost of drugs passed on to patients[;] [e]thical concerns about inappropriate pressures being made on physicians with respect to gifts and other benefits being distributed by drug rep­ resentatives[;] [t]he banning of pharmaceutical drug representatives from some medical campuses includ­ ing stanford, henry ford and rush university medi­ cal centers.121 further exploration of each issue is necessary to foster an understand­ ing of the pros and cons of physician gift bans by state and federal legisla­ tures. a. what effect do gifts have on physicians' prescribing habits? in a study conducted in 2000 and published in the journal of the american medical association, ashley wazana found that freebies and 117. the prescription project survey, (june 2008), http://www.prescriptionproject.org/ assets!pdfs/prescripton%20project%20survey _ 0618.pdf (last visited jul. 9, 2009). 118. jd. 119. id. 120. id. 121. ogan gurel, md, counterdetailing: a cure for a pharmaceutical addiction? (mar. 17, 2008), http://www.midwestbusiness.com/news!viewnews.asp?newsletterid= 19002 (last visited jul. 9, 2009). 2010] under the influence 105 honorariums had a significant impact on physicians' prescribing habits.122 w azana found that when pharmaceutical companies paid for a physician to attend a conference2 the physician prescribed that company's drugs 4.5-10 times more often.1 3 physicians who answered that they "occasionally'' accepted free meals from pharmaceutical companies "were 2.3 times more likely than other doctors to request that the sponsor's drug be added to a hospital formulary. "124 when physicians "often" accepted free meals from pharmaceutical companies, they "were 14 times more likely to do so."125 despite the fact that many physicians admitted to some form of interaction with drug representatives, when asked if those representatives ''fairly por­ tray their product," 80% said no, while 75% said that the representatives ''use unethical practices."126 it is unnecessary to paint physicians as villains who are easily swayed by free pizza or readily seduced by cunning drug representatives. even the most well-intentioned doctor could fall pre~ to his or her subconscience after being subjected to freebies and drug ads.1 7 despite what some physicians say, studies and social science show that pharmaceutical companies' gifts to physicians have a profound impact on physicians' prescribing habits.128 dr. david blumenthal suggests that "humans are vulnerable to a powerful, unconscious 'self-serving bias'; that is, they have trouble seeing themselves as biased when the bias serves their needs or advances their own perceived interests."129 this means that even the smallest gifts from pharmaceutical companies may influence physi­ cians' prescribing habits, since they may feel an obligation to reciprocate, either consciously or subconsciously.130 blumenthal is skeptical that states' disclosure laws and gift limits will affect the relationship between pharma­ ceutical companies and physicians in the long run because such relation­ ships are important to both parties: pharmaceutical companies need to sell their product, while physicians need to stay educated on cutting-edge drugs and therapies.131 he predicts recurring cycles of scandal and reform for the future. 132 122. ashley wazana, physicians and the pharmaceutical industry: is a gift ever just a gift?, 283 jama 373 (2000) 123. id at 378. 124. alex roslin, big pharma's pill pusherswhy americans are addicted to expen­ sive prescription drugs (sep. 4, 2008), http://www.straight.com/print/160083# (last visited jul. 21, 2009). 125. id 126. wazana, supra note 122, at 377. 127. david blumenthal, md, doctors and drug companies, 351 new eng. j. med. 1885, 1887 (2004), available at http://contentnejm.org/cgi/reprint/351118/1885.pdf. 128. see, eg., wazana, supra note 122, at 377; blumenthal, supra note 129, at 1887. 129. blumenthal, supra note 129, at 1887 (citing jason dana & george loewenstein, a social &ience perspective on gifts to physicians from industry, 290 jama 252, 252-5 (2003)). 130. blumenthal, supra note 129, at 1887. 131. /d. at 1889. 132. id 106 indiana heal til law review [vol. 7:89 b. are pharmaceutical representatives qualified to educate doctors about new drogs? shahram ahari, former drug representative for eli lilly, made a splash when he disclosed the dark side of pharmaceutical companies to sponsors ,of the ppsa and abc news.133 ahari alleged that drug repre­ sentatives were hired on the basis of looks and charisma, and in his expe­ rience, the vast majority lacked any sort of science background.134 ahari alleged that drug representatives are encouraged to use questionable sales tactics, "including how to exceed spending limits for important clients, be­ ing generous with free samples to leverage sales, using friendships and per­ sonal gifts to foster a 'quid pro quo' relationship, and how to exploit sexual tension. "135 there is also widespread concern in the medical community that bans and limits on physicians' interactions with drug representatives hurt patients because they limit the drug comp;my's ability to convey information about new drugs and the latest innovations in medical research. logic dictates that a prescribing physician cannot recommend a therapy or drug if he or she does not know it exists. scott lassman, phrma counsel, expressed such a concern: "[t]he new policies [are] a 'disservice to patients and phy­ sicians' because they keep doctors from interacting with sales representa­ tives. 'the company sales representatives, in our point of view, have a lot of useful information on drug products and how to use them, and how not to use them. "'136 this view is undoubtedly shared by many in the medical community. while some drug representatives, such as ahari, claim that they are instructed to participate in questionable sales tactics, a spokesman for eli lilly countered ahari's claims: 'we think his examples are exaggerated. we have policies in place that allow us to engage in interac­ tions with health care professionals at an appropriate level and they are intended to provide infonnation about our products so that they will be able to make appropriate medical decisions for their patients.' 137 . 133. marcus baram. ex-drug sales rep tells all, abc news, (2009) http://abcnews.go.com/us/story?id=4438095&page=l (last visited jul. 9, 2009). 134. id 135. /d. 136. andrew pollack, stanford to ban drug m.alrers' gifts to doctors, even pens, n.y. dmes, sep. 12, 2006, available at http:/lwww.nytimes.com/2006/09/12/business/ 12drug.html? _r= l &ref=business&oref--slogin. 137. baram.supranote 135. 2010] under the influence 107 meanwhile, stanford university medical center prohibited even the smallest gifts to its physicians by pharmaceutical companies in an effort to reduce the influence that pharmaceutical companies have on its physician's prescribing habits.138 . . .. · in response to the new york times article, some physicians claimed that·the stanford limits were much too strict; in fact, some claimed that the ama guidelines were too stringent as well.139 these physicians claim that the interaction between drug representatives and physicians is vital to. in­ forming their prescribing habits; others expressed outrage at the insinuation that a trinket, such as a pen or a measuring tape with a drug's name on it, would have a great effect on their prescribing habits.140 • · . a key concern is the accuracy of the information provided by pharma"' ceutical representatives. one study, conducted by researchers at the .uni-· versity of california at san diego school of medicine, found that 12 of 106 statements made by ~harmaceutical representatives, and later tested for ac­ curacy, were false.1 this means that 11% of the statements contradicted information available to the representatives.142 most frightening is. the fact that the physicians to· whom the information was given were not·aware of the inaccuracy of the statements.143 unsurprisingly, marketing material used by pharmaceutical companies often has a bias toward ·the company distributing it.144 in addition to providing skewed information, marketing material sometimes does not comport with fda regulations "against. pro­ moting unapproved uses of drugs."145 the fact that some pharmaceutical representatives fail to accurately inform physicians about their product, coupled with questionable marketing materials suggests that pharmaceutical companies are not the best resource from which physicians should receive information about new drugs and therapies. c. economic concerns if these advertisements and gifts bring physicians to a level of aware­ ness about new innovations in drug therapy without adverse influence on their prescribing habits, what is the harm? look no further than your pock138. pollack, supra note 138. 139. reader feedback: is limiting industry gifts a smarl policy?, fierce healmcare, sep. 15, 2006, available at http:/lwww.fiercehealthcare.com/storylreader-feedback-is-limiting­ industty-gifts-a-smart-policy212006-09-15. 140. jd. 141. m.g. ziegler, et al, the accuracy of drug information from pharmaceutical representatives, 273 jama 1296, 1296-7 (1995). . . 142. id. 143. id. at 1297. 144. daniel stryer ·& lisa bero, characteristics of materials distributed by drug companies, 11 j. gen. intern. med. 575, 579 ( 1996), available at http://www.springerlink. com/content/f625624628q5m333/fulltext.pdf. 145. id. . 108 indiana health law review [vol. 7:89 etbook. most state legislatures have cited the growing costs of prescription drugs as a primary concern when enacting legislation banning gifts to phy­ sicians.146 while massachusetts' approach is very specific and may come with some administrative costs, other states' disclosure laws may not get to the root of the problem. there is little evidence that requiring pharmaceuti­ cal companies to be accountable for their advertising expenditures reduces spending on physician gifts and other marketing avenues. marketing can have a drastic effect on how a drug is perceived. '"the explosion in drug costs is directly proportional to marketing,"' says alan cassels7 a pharmaceutical 1p.3rketing researcher from the university of vic­ toria.14 cassel further stated, "'[p]harmacists have told me they can tell when a certain company's dru§ rep has been in town because of a spike in that company's prescriptions.'" 48 astrazeneca, makers of prilosec and nexium, has exhibited "bio­ chemical chutzpah" in its marketing of the drugs. 149 the patent on prilosec, the world's best-selling drug, ran out in 2001, prompting astrazeneca to use a mirror image of the drug's isomers to create nexium; the only differ­ ence between the two drugs is that ''nexium is 3 percent better at relieving symptoms."150 [nt a: the previous citation was nearly a direct quote from the source; to simplify, i made is a direct quote]. despite the lack of"signif­ icant clinical advance," nexium was approved by the fda that same year. 151 immediately after approval was granted, astrazeneca launched an aggressive marketing campaign aimed at "getting doctors and patients to switch from prilosec to ... nexium."152 as a result of this marketing blitz, prilosec is still available over-the-counter, and costs consumers about $30.153 its nearly identical counterpart, nexium, costs about $200.154 this demonstrates the remarkable effect that marketing techniques have on pre­ scribers and patients. economic concerns of rising marketing and advertising expenditures of pharmaceutical companies cannot be overlooked. according to jason dana and george loewenstein, "[g]ifts from the pharmaceutical industry contribute to the rapidly increasing cost of medical care, and more specifi­ cally, to the increase in expenditures on prescription drugs."155 this is sup146. see eg., massachusetts senate bill no. 2863 (2008). 147. roslin, supra note 124. 148. /d. 149. robert bazell, the costly side effects of nexium 'sad blitz, nbc news (august 14, 2007), available at http:/ /www.msnbc.msn.com/id/202495911. 150. /d. 151. /d 152. id 153. /d. 154. id. 155. jason dana & george loewenstein, a social &ience perspective on gifts to phy­ sicians from industry, 290 jama 252,252 (2003). 2010] under the influence 109 ported by the doubling of prescription drug spending by patient consumers from 1995 to 2000, with an increase of 17%, attributable to physicians' pre­ scribing more expensive drugs, in 2001.156 pharmaceutical representatives tout the innovation of new drugs to physicians, which is supposed to offset or justify the increased cost of these new drugs. however, [f]rom 1989 to 2000, the us food and drug adminis­ tration judged 76% of all approved new drugs to be no more than moderate innovations over existing treatments, with many being a modification to an old­ er product with the same ingredient. in 2000, the av­ erage price of these standard-rated new drugs was nearly twice the average price of existing drugs pre­ scribed for the same indications. 157 therefore, even though the overall effectiveness of most prescription drugs has not changed, the price of these drugs has increased far past the rate of inflation, resulting in no more bang for your buck. back in massachusetts, medical conventions are being cancelled due to the new gift ban, causing some to wonder if the law is hurting the econ­ omy. the cancellation of a convention results in lost convention revenues for the city, as well as lost accommodation costs and entertainment exd. 158 pen 1tures. administrative costs induced by recordkeeping mandates may out­ weigh any perceived benefit of disclosure. the added costs and effort asso­ ciated with such a recordkeeping requirement has spawned the introduction of companies seeking to capitalize on the gap in the market for physician gift registries. one company offers gift registry databases for physicians and pharmaceutical companies to maintain their compliance with record­ keeping requirements. this, of course, is not a complimentary service. d. does banning free drug samples hurt patients? the availability of drug samples from pharmaceutical companies is al­ so a concern. a 2000 study examined the effect of drug samples on physi­ cians' prescribing habits. 159 survey participants, all physicians at university of washington-based clinics, were presented with three different 156. id at252-3. 157. !d. at253. 158. john gever, medical group pulls meeting from boston over state ethics law, medpage today (january 22, 2009), http://www.medpagetoday.com/publichealthpolicy/ healthpolicy/12567 (last visited jul. 9, 2009). 159. lisa d. chew, et al., a physician survey on the effect of drug sample availability on physicians' behavior, 15 j. gen. intern. med. 478,478 (2000). 110 indiana health law review [vol. 7:89 prescribing scenarios.160 the first hypothetical patient ·was an insured woman with a simple urinary tract infection; the second was an uninsured man with hypertension.161 the third ''patient" was an uninsured woman with ·~ew onset depression."162 the survey physicians were then asked what their preferred therapy was for each hypothetical patient.163 in the first scenario, only 1% of the doctors stated that their preferred therapy was ciprofloxacin; however, when drug samples were available, 17% of those doctors dispensed ciprofloxacin, regardless of the fact that 92% of them preferred another drug.164 the doctors justified their decision by reasoning that they wanted to immediately commence the patient's treatment and save the patient a trip to the pharmacy.165 in the second scenario, 91% of doctors selected a drug sample instead of their preferred therapy, citing prevention of extra financial burden on the uninsured patient.166 in a follow-up scenario, where the same patient re­ turned with the same symptoms but was insured, 69% of doctors said they would write a prescription for the drug sample·instead of switching the pa­ tient's medication, while 88% said they would write a prescription for their ... 1 ~ d th 167 tnttia pre1erre erapy. finally, for the third ''patient," an uninsured woman suffering from depression, 69% of doctors preferred a selective serotonin reuptake inhibi­ tor.168 of the 82% of respondents who said they would dispense a drug sample, 49% would dispense a drug sample inconsistent with their preferred therapy.169 as in the second scenario, most doctors cited the need to ease the financial burden on the uninsured patient as justification. for their beha­ vior. 170, , , researchers stated that their ''most disturbing fmding [was] that the presence of drug samples may influence physicians to diwense or prescribe drugs that differ[ ed] from their preferred drug choice."1 this ultimately means that compliance with industry guidelines for dis~ensing certain ther­ apies for certain illnesses or symptoms is compromised. 72 while it would seem that drug samples help less fortunate patients, by offering doctors a free alternative· to prescription medicine, a study by re­ searchers at harvard medical school and cambridge health alliance indi160. ld. at 479-80. 161. ld. at479. 162. ld. 163. ld. 164. ld. at480. 165. chew, supra note 162, at 480. 166. ld. at481. 167. ld. 168. ld. 169. ld. 170. ld. 171. chew, supra note 162, at 482. 172. ld. 2010] under the influence 111 cated that most free drug samples go to aftluent patients.173 this is because poor patients do not often visit the doctor's office due to the expense of keeping an appointment.174 the study found that only 28% of patients re­ ceiving drug samples were below the poverty level.175 according to sarah cutrona, md, lead author of the study, '"[d]octors like to give free samples, and patients like to get them, and no one wants to think of them as a power­ ful marketing tool of the drug industry ... but that's what samples are. and what they really are not is a safety net for the needy."'176 this is con­ trary to the opinion of ken johnson, vice-president ofphrma, who claims that drug samples help patients and "often lead to improved quality of life for millions of americans, regardless of their income."177 yet another doc­ tor asserts that the drug samples do not go to needy patients, but usually go home with physicians and their employees instead.178 it appears that drug samples do help some patients, but not those who need them most. e. ethical concerns florida physician james p. orlowski refuses to let pharmaceutical companies influence the way he prescribes medication to patients; he has a self-imposed ban on drug representatives entering his tampa bay office, rejecting all industry gifts, even pens.179 although orlowski would prefer that congress and the state legislatures refrain from getting involved, he believes that the high visibility of the legislation may open up his col­ leagues' eyes to this rampant problem.180 indeed, physicians can be inundated with gifts; one anonymous mem­ ber of the national physician's alliance turned down 12 free breakfasts, 18 lunches, 16 branded pens, a branded eyeglasses cleaner, two branded pen lanyards, branded pill holders, post-it notes, notejm!.ds, a pocket physicians desk reference, correction paper strips, a coffee mug, a poster, a hig173. barbara basler, free drug samples help the well-off more than the poor, the prescription project, jan. 4, 2008, available at http://www.prescriptionproject.org/assets/ pdfs/basler _ aarp _samples _jan-2008.pdf. 174. id. 175. id. 176. id. 177. id. 178. howard brody, md, the company we keep: why physicians should refuse to see pharmaceutical representatives, 3 ann. fam. med. 82, 84 (2005), available at http://www.annfammed.org/cgilreprint/3/1/82. 179. kris hundley, doctor combats pull of drug reps, st. petersburg times, dec.27, 2007, available at http://www.sptimes.com/2007/12/27/business/doctor_combats _pull_ o.shtml. 180. ld. 112 indiana health law review blighter, a diagnostic manual, a giant clip-refrigerator magnet, a ruler, a water-oil globe, a history ofviagra book and a viagra soap dispenser in only a monthlsi and-a-half. [vol. 7:89 this inundation of gifts has prompted some physicians to call for the profession-wide refusal of pharmaceutical company gifts.182 dr. howard brody183 frames the ethical argument in the following way: 1. as a matter of professional integrity, i claim that i ought to behave in accord with certain principles. 2. empirical evidence shows that i am highly likely to behave in ways contrary to my professional principles when i keep company with [pharmaceutical repre­ sentatives]. 3. my professional responsibilities do not require me to keep company with [pharmaceutical representatives]. 4. if, therefore, i choose to continue to keep company with [pharmaceutical representa­ tives], i cannot claim that i truly wish to adhere to h £'. • 1 . . 1 184 t ose pro.tessiona pnnc1p es. brody goes on to explain that empirical evidence demonstrates not on­ ly that physicians are influenced by pharmaceutical representatives, but that they do not realize they are being influenced.185 he also says that spending time with pharmaceutical representatives is often a waste of time, and that most physicians do not allow themselves time to later check the representa­ tive's statements for accuracy and bias.186 the only way for the physician­ pharmaceutical representative relationship to be an effective educational tool would be "[for physicians to] spend time with reps in a manner that preserves professional integrity[, which] would require both refusing to ac­ cept their gifts and srending a great deal of valuable time double-checking their information."18 brody thinks that physicians could spend their time . 1 188 morew1se y. the primary ethical concern regarding pharmaceutical company gifts to physicians is whether the gift clouds the physician's judgment in pre181. !d. 182. brody, supra note 181, at 82. 183. !d. brody is a professor and director for the institute for the medical humanities, university of texas medical branch at galveston. he is also the author of hooked: ethics, the medical profession, and the pharmaceutical industry (rowman & littlefield 2007). 184. brody, supra note 181, at 83. 185. !d. at 82. 186. !d. 187. id. at 84. 188. !d. at 85. 2010] under the influence 113 scribing medicine. nurse practitioners with prescribing privileges are not immune to this phenomenon either.189 the problem is that "gifts entice health professionals into relationships that subtly call for reciprocity, and have been shown to influence prescribing behaviors."190 some also fear that doctors overprescribe medications, rather than offering cheaper alterna. . . d 191 f 1 d "b h t1ves to prescnpt10n rugs. or examp e, octors may prescn e ormone replacement therapy for menopausal women, when simply shedding a layer of clothing and ~etting a good night's sleep might help alleviate their symp­ toms, sans drug:92 ethical concerns are also illuminated when considering advertisements in medical journals.193 medical journals have multiple obligations that may conflict.194 such obligations include ''the independence of journal re­ ports[both] to their professional subscribers and by extension to the public. these obligations could conflict because unbiased reporting is expected."195 when journals publish advertisements, they are making a choice to promote a particular drug due to their financial obli~ations, when independent judgd. h . ul h . t96 ment may not 1ctate t at partie ar c mce. g. first amendment issues yet another issue that concerns opponents of .physician gift bans is whether it impedes on the exercise of free speech.19 in 1976, the united states supreme court struck down a virginia statute that prohibited virgin­ ia pharmacies from advertising their drug prices. the court reasoned that the advertisements had value as commercial speech.198 advertisements from pharmaceutical companies are generally regarded as commercial speech, rather than personal speech, which is regarded as a higher form of speech, and thus more protected.199 in order to pass constitutional muster, a restriction on commercial speech must have a substantial governmental interest that is directly advanced by the restriction.200 in addition, the re189. charlene l. stokamer, pharmaceutical gift giving: analysis of an ethical dilemma, 33 jona 48, 48 (2003). 190. /d. 191. /d. 192. id. at 50. 193. /d. 194. /d. 195. stokamer, supra note 192, at 50. 196. see eg., id 197. aaron s. kesselheim, md, jd & jerry avom, md, pharmaceutical promotion to physicians and first amendment rights, 358 new engl. j. med. 1727 (2008), available at http://content.nejm.org/cgi/content/fu.iv358/16/1727. 198. /d. at 1728. (referring to and citing virginia state board of pharmacy v. virginia citizens council, inc., 425 u.s. 748 (1976)). 199. kesselheim, supra note 201, at 1728. 200. /d. 114 indiana health law review [vol. 7:89 striction must be no more broad than necessary to accomplish its goals.201 can state statutes limiting or banning physician gifts survive this in­ termediate level of scrutiny? some argue that limitations on marketing ha­ bits of pharmaceutical comganies "can improve prescribing decisions and protect the public's health.' 02 it appears, however, that new state legisla­ tion preventing pharmaceutical companies from using prescribing habit in­ formation will pass constitutional muster, at least according to the first circuit.203 the statute there, however, limited pharmaceutical companies' access to information mined for the purpose of tailoring marketing efforts to specific physicians?04 it remains to be seen whether restrictions on phar­ maceutical company gifts to physicians will be supported by the courts. h. what is the best solution? limits and bans on such gifts are just one way to combat the effect of pharmaceutical industry influence on physicians. while an outright ban, such as the one implemented in massachusetts, seems harsh, there is little evidence that lesser limitations, such as those implemented in west virgin­ ia, have had any great effect on this problem. indiana's biggest pharmaceutical company, eli lilly, has already tak­ en proactive steps to anticipatorily comply with the ppsa. the ppsa, however, only requires reporting and disclosure of gifts; it does not limit such gifts to physicians. an outright ban, such as the massachusetts ban, would likely be more effective at curbing the influence that uninformed (though perfectly coiffed) drug representatives· have on physicians who should know better. the ppsa and the massachusetts ban are on opposite ends of the spectrum, with minnesota's limits in between. while a happy medium seems favorable, it is evident that drastic measures will need to be taken in order to reverse the troubling trend that is unfolding in the health care in­ dustry because of pharmaceutical companies' gifts to physicians. there appears to be a fine line between educating physicians about new pharma­ ceutical therapies and influencing them to write a prescription that they normally would not, if not for external factors. as far as institutional policies which restrict contact between pharma­ ceutical representatives and physicians go, one study has suggested that physicians who had been trained on the policy after it had taken effect were much more skeptical of statements made by pharmaceutical representa201. id 202. id. at 1731. 203. kevin b. o'reilly, new hampshire ban on sale of prescribing data, amer. med.news, dec. 22, 2008, available at http://www.ama-assn.org/amednews/2008/12/ 22/prsc 1222.htm. 204. id 2010] under nie influence 115 tives?05 a restrictive policy, however, did not affect whether a physician would meet with the pharmaceutical representative.206 this study seems to indicate that restrictive policies in medical institutions do affect the way physicians think about their interactions with drug companies;207 a state­ imposed policy regarding gifts and disclosure may have a similar effect. the fda advertising limits, however, are unnecessarily stringent. since television viewers are so inundated with parades of atrocious side effects so frequently, risks of warnings and side effects can often fall on deaf ears. some side effects may be minimal, but because of their promi­ nent placement in drug commercials, it also could cause some viewers to be too terrified to try a drug that could help them more than hurt them. the fda advertising limits create an advertising environment for prescription drug advertisers which forces pharmaceutical companies to produce the same bland commercials with the same frightening side effects. this likely does not aid in promoting a product as efficiently as could be done if the fda's requirements were not so limiting. if pharmaceutical companies could realistically portray their products, rather than show people walking hand-in-hand across a field of flowers whilst discussing their genital herpes, it may create more of a desire in consumer-patients to become educated about the product. the advertisement restrictions are unfair in the sense that they prohibit the pharmaceutical companies from flaunting the positive aspects of their products and instead force them to recite a laundry list of horrendous side effects. v. conclusion studies have shown that gifts from pharmaceutical companies, phar­ maceutical. advertisements, and information tendered from pharmaceutical representatives may have an effect on physicians' prescribing habits. eco­ nomic and ethical concerns are at the heart of the issue of pharmaceutical company influence. states have attempted to curb this influence through legislation designed to limit or ban gifts to physicians and mandate disclo­ sures for certain types of gifts. for most state legislation, it is too early to tell whether such legislation will have any effect on physicians' prescribing habits and limiting pharmaceutical company influence. there has been very little litigation relating to the state statutes. the ppsa, if passed, will provide consistency in disclosure and recordk:eeping, while allowing states to maintain stricter standards if they wish. some physicians are concerned that they will be unable to obtain information about new drugs and thera205. george d. comerci, long-term effects of restricting residents' contact with drug representatives, 7 aap grand rounds 32 (2002), available at http://aapgrandrounds. aappublications.orglcgi/reprint/7 /3/32. 206. /d. 207. id. 116 indiana health law review [vol. 7:89 pies once state and federal legislation goes into effect. there is evidence, however, that information disseminated by pharmaceutical companies can be biased and even inaccurate. the key to global peace on this issue appears to be a balancing of the free-flowing dissemination of information between pharmaceutical compa­ nies and physicians regarding new drug information and therapies with the influence of gift-giving on physicians' prescribing habits. disclosure plays a key role in achieving this balance, as is evident in the implementation of recordkeeping and disclosure statutes in states across the nation. the best way to prevent pharmaceutical company influence on physi­ cians remains to be seen. once the state plans have been in effect for aw­ hile, it will be easier to see what is most effective at curbing this undue influence. for now, it is important for doctors to realize that, no matter how esteemed and educated, they are not immune to pharmaceutical company influence. awareness of the problem will lead to a better solution. only then will fictional marie, and the rest of the american public, be able to rest easy, confident that their doctors are making well-informed, independent decisions solely for the health of their patients. emilie w. clemmens emilie w. clemmens is the co-founder of the forum on science ethics and policy (fosep, www.fosep.org), a seattle, wa area organization dedicated to promoting dialogue between scientists, policy experts, and the public. fosep has hosted seminars on topics ranging from cloning to genetically modified foods, including a public forum on stem cells that was attended by over 700 members ofthe public, academia, and state and federal legislatures. emilie received her ph.d. in 2003 from the department of bioengineering at the university of washington, and recently spent the fall of 2004 in washington, d.c. as a christine mirzayan science & technology policy fellow at the national academies in washington, d.c. she most recently was a research associate for the space studies board at the national academies. creating human embryos for research: a scientist's perspective on managing the legal and ethical issues emilie w. clemmens, ph.d. introduction the use and creation of human embryos in the laboratory has generated considerable controversy for the past three decades. this debate has recently been reenergized by stem cell research, a marvel touted as perhaps "the most remarkable breakthrough since man walked on the moon. "1 though stem cells are available from several sources, scientists believe embryonic stem cells, due to their unique capacities for self-renewal and differentiation into any human cell type, might be used to cure diseases, regenerate tissue, and change medi­ cine as we know it 2 embryonic stem cell lines can be derived either through the destruction of spare human embryos donated from in vitro fertility (nf) efforts or through human embryos created specifically for their use in stem cell research. 3 though neither is currently eligible for federal funding, 4 the former is less ethically charged and has been recommended by all of the federal ethical boards addressing human embryo research thus far. 5 nonetheless, scientists have expressed a desire to create human embryos exclusively for research purposes for a number of reasons including appropriate experimental controls, lesser quality and lack of available excess ivf embryos, and a desire to investigate cloning embryos for specifically non-reproductive, therapeutic 1. stem cell research: hearing before the. subcomm. on labor, health and human servs. andeduc. of the senate appropriations comm, 1 08th cong. (2003) (statement ofsenator arlen specter, subcom. chairman). 2. thomas b. okarma, human embryonic stem cells: a primer on the technology and its medical applications, in the human embryonic stemce!ldbbate 3 (suzanne holland et al. eds., 2001 ). 3. nat'l insts. of healtii, l report of the human embryo research panel xi (sept 1994) [hereinafter herp report], available at http://ospp.od.nih.gov/pdf7volume 1 revised.pdf. 4. balanced budget downpayment act, i, pub. l. no. 104-99, § 128, 110 stat. 26,34 (1996); departments of labor, health and human services, and education, and related agencies appropriations act, 1998, pub. l. no. 105-78, § 513,111 stat. 1467, 1517 (1997). 5. see generally herpreport,supranote 3; etidcsadvisorybd.,dep'tofhealtii, educ., & welfare, report and concwsions: hew support of research involving human in vitro fertilization and embryo transfer (may 4, 1979) [hereinafter eab report); nat'l bioetidcs advisory comm'n, etidcal issues in stem cell research: executive summary (sept. 1999) [hereinafter nbac report], available at http://www.georgetown.edu/researcblnrobl/nbac/execsumm.pdf. 96 indiana health law review [vol. 2:93 purposes. 6 but a lack of federal funding will slow this nascent research, as the incentives for private investment are few at this stage and federal monies are needed to enhance the volume of high quality, peer-reviewed research for the development of this science as a clinical tool. 7 though the creation and use of human embryos ex utero would un­ doubtedly advance scientific achievements on multiple fronts, ethical and legal questions temper our rush to pursue this path. this article will address the current united states legal situation regarding human embryo research and the creation of embryos, and will look to the legal history of human embryo research to investigate prevailing ethical notions of the creation of embryos in vitro and their effects on the development of policy. finally, this article will discuss the potential future ramifications of a lack of federal funding and, thus, oversight on embryo creation and use in research, while casting a cautious eye to great britain as a model for support and regulation of the use of human embryos in re8earch. i. creating life outside the womb: the science of nf technology in vitro fertilization (nf) includes the processes of ovulation induction, egg retrieval, fertilization, and embryo transfer. drugs that manipulate hor­ mones to promote ovulation are injected into the female. 8 after an appropriate interval to allow oocyte maturation, eggs are typically retrieved with ultra­ sound-guided aspiration through the vagina and cervix,9 and are incubated with 50,000to 1,000,000 sperm for 14-18hours.1° followingtransfertoanew growth medium, the eggs are examined for the presence of two pronuclei, an 6. ronald m. green, the human embryo research debates bioethics in the vortex of controversy xi-xii, 15 (200 1 ); james f. childress, an ethical defense of federal fundingfor human embryonic stem cell research, 2 y alej. heal1hpol'y l. & e1hics 157, 159-60 (2001 ); david i. hoffinan et al., cryopreserved embryos in the united states and their availability for research, 79 fertility & sterility 1063, 1068 (2003), available at http:/ /www.asrm.org/professionals/fertility&sterility/cryoembryos _ may2003.pdf; dr. john gearhart, medical promise ofembryonic stem cell research (present and projected), address before the president's council on bioethics (apr. 25, 2002), available at http://bioethics.gov/ transcriptslapr02/apr25session1.html. 7. audrey r. chapman et al., american association for the advancement of science & institute for civil society, stem cell research and applications: monitoring the frontiers of biomedical research vi (nov. 1999), available at http://www.aaas.org/spp/sfrvprojects/ stem/report. pdf; see also stem cell research: the ethics of going it alone, sitnflash (harvard medical school, boston, mass.) mar. 2004, at http://www.sitnboston.org/sitnflash/archives/ sitnflash-200403.html (last visited apr. 17, 2005) (on file with the indiana health law review). 8. resolve the national infertility association, treatment: assisted reproductive technology, at http://www.resolve.org/mainlnationalltreatment/options/artlart.jsp?name= treatment&tag=options (last visited apr. 17, 2005) (on file with the indiana health law review) [hereinafter resolve]. 9. infertility counseling associates, an overview of the ivf procedure, at http://www.mindspring.com/-yepstein/procivf.htm(lastvisitedapr.l7,2005)(onfilewiththe indiana health law review). 10. resolve, supra note 8. 2005] creating human embryos for research 97 indicator that normal fertilization has occurred.11 approximately three days later, the embryos are morphologically assessed for quality, and two to four embryos chosen by the embryologist are flushed into the uterus through a catheter. 12 for the female, the nf process is intricate, difficult, and potentially harmful. frequent blood draws are performed to monitor estrogen levels. 13 the ovary'-stimulating medications may cause pain, bloating, or in rare cases ovarian hyper-stimulation syndrome, which can cause kidney failure, throm­ bosis, and death.14 preliminary studies suggest a possible link between ovary­ stimulating medications and ovarian cancer. 15 injury during egg retrieval to adjacent organs and blood vessels has been reported in the literature.16 finally, the need to transfer multiple eggs to the uterus to improve the chances of im­ plantation has led to a high incidence of multiple births, which can increase the "risk of complications or even miscarriage, as well as long-term disability, and they can cause considerable emotional and financial pressure," according to ruth deech, ex-chair of the human fertilisation and embryology authority (hfea) in the united kingdom.17 the current procedure of extracting and fertilizing multiple eggs respects a woman's health by lowering the number of times she may need to undergo the procedure, and respects a family's welfare by considering the high cost of the procedure. but the number of embryos transferred to the uterus must be limited to avoid multiple birth complications. 18 thus through ivf, creation and cryopreservation of excess embryos have become the norm. according to a recent report, there are approximately 400,000 cryopreserved embryos in storage in the united states. 19 it seems unlikely that all these embryos will be used to attempt pregnancies and thus, given informed donor consent, they might be used in research rather than discarded. however, only 2.8 percent of those stored embryos are currently available for research.20 beyond this, scientists argue that spare nf embryos, which are typically of lesser quality than those used for implantation, may not be useful for 11. /d 12. /d 13. id 14. pregnancymd.org, fact sheets: ovarian hyperstimulation syndrome (ohss), at http://www.pregnancymd.org/ovarian-hyperstimulation-syndrome-ohss.htm(lastupdatedsept 17, 2001) (on file with the indiana health law review). 15. americansocietyforreproductivemedicine. fact sheet: risks of in vitro fertiijzation (ivf) (dec. 19%), available at http://www.asnn.org/patients/factsheets/ risksivf-factpdf. 16. /d. 17. modern fertility techniques boost success rates, bbc news, dec. 15, 1998, at http:/news.bbc.co.uk/1/hilhealth/235510.stm (last visited apr. 17, 2005) (on file with the indiana health law review). 18. !d. 19. hoffinan et al., supra note 6, at 1 068~ 20. /d. 98 indiana health law review [vol. 2:93 developing stem cell lines of enough quantity and quality for therapeutic application/1 and that embryo creation is critical to the advancement of thera­ peutic cloning, a novel technology that may transform medicine.22 also, crea­ tion of embryos not intended for ivf is necessary for appropriate controls for meaningful studies of embryonic development 23 the development of ivf technology progressed over the years as all clinical research progresses­ through the use and study of animal counterparts.24 the media conditions, manipulation of sperm and egg, and even cryopreservation techniques were all attempted and optimized with animal gametes and embryos before attempts with human specimens were made. 2s animal studies are typically undertaken so· that large numbers of experiments may be performed to gather general information about the equivalent human system, with the hope that the same principles will apply and that few (and relatively non-invasive) human tests will be necessary to understand the human response to a drug or technology. yet, scientists are continuously discovering important differences between animal and human systems. for example, though embryological studies with animal cells have yielded a wealth of information about early mammalian development, evidence suggests that human and other mammalian embryos are significantly different in form and function. 26 the science appears to have come to the point that studies with human embryos are necessary to acquire new information on human embryonic development. thus simply put, furthering our understanding of human embryonic development to the benefit of science and medicine (pediatric care in parti­ cular) will require research with human embryos. yet both the use and crea­ tion of human embryos for basic science research and for therapeutic purposes · demands a careful consideration of policy and ethics. 21. gearhart, supra note 6. 22. sideny altman et al., statement by 40 nobel laureates regarding cloning (apr. 10, 2002),availableathttp:l/www.ascb.orwpublicpolicy/nobelletter.html;americ.ansocietyfor ceil biology, position paper on cloning: somatic ceil nuclear transfer technologyisjustifiedandessentialforproducingembryonic stemcei.lsforbasic researchand1herapeuticappucations(dec.3,2001),avai/ableathttp://www.ascb.org/ publicpolicy/cloning.htm. 23. green,supranote6, at7-10. 24. id. 25. jonathan van blerkom, the history, current status and future direction of research involving human embryos, in 2 papers commissioned for the human embryo research panel 1 (nat'l inst. ofhealth, pub. no. 95-3916, sept 1994). 26. jamesa. thomson,humanembryonicstemcells,inlhehumanembryonicstem ceil debate, supra note 2, at 15, 20; yves j.r. menezo & francois herubel, mouse and bovine models for human ivf, 4 reproductive biomedicine online 170, 170 (2002). 2005] creating human embryos for research 99 ii. current human embryo research policy a. federal law currently, there is no federal law criminalizing the creation of human embryos in vitro. the creation of embryos through in vitro fertilization (ivf) ofhuman oocytes with human sperm is a medically accepted practice designed to assist infertile couples or individuals with childbearing. 27 embryos created in this manner, referred to in this article as ''preimplantation embryos," are ultimately either successfully implanted into a woman's womb, indefmitely cryogenically preserved, or destroyed through failure to implant, natural gene­ tic destruction mechanisms, failure to survive the freezing process,28 or by con­ tractual enforcement to cease storage and destroy. 29 some of these embryos, particularly those in the latter category, might be employed for scientific research purposes. though there is no federal law prohibiting this use of human embryos, federal funding for "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death" was banned in 1996 by congress' passage of the dickey amendment to the balanced budget downpayment act of 1996.3° federal funding for the creation of embryos for research purposes was also banned by this amend­ ment.31 current policy regarding the use of human embryos in the derivation of stem cell lines was established by president george w. bush's pronouncement that federal funding for human embryonic stem cell research is limited to cell lines derived from embryos before august 9, 2001.32 this policy is consistent with the dickey amendment, as it does not allow federal monies to be used in the destruction of human embryos/3 but permits funding for research using stem cells derived from spare ivf embryos for which "the life-and-death decisions have already been made."34 nonetheless, both groups opposed to and in favor of the use ofhuman embryos to create stem cells were unappeased 27. american med. ass'n., code ofmedicaletihcs e-2.141n vitro fertilization (june 1983), available at http://www.ama-assn.orglapps/pf_new/pf_online?f_n=resultlink &doc=po 1 icyfile s/hne/e-2 .14. htm&s_ t=in+vi tro+ferti 1 izati on& catg= ama/hne&catg=ama/bngnc&catg=ama/dir&&nth=1&&st_p=o&nth=2&. 28. john m. baust, molecular mechanisms of cellular demise associated with cryopreservation failure, 1 ceil preservation tech. 17 (2002). 29. litowitz v. litowitz, 48 p.3d 261, 271 (wash. 2002). 30. balanced budget downpayment act, i, pub. l. no. 104-99, § 128, 110 stat. 26, 34 (1996). 31. !d. 32. remarks by the president on stem cell research, u.s. newswire, aug. 9, 2001, at national desk [hereinafter remarks]. 33. minutes, national institutes of health, proceedings of the 78th meeting of the advisory committee to the director (june 3, 1999), available at http://www.nih.gov/about/director/minutes699.htm. 34. remarks, supra note 32. 100 indiana health law review [vol. 2:93 by the bush administration's policy, in part because the decision failed to address either the moral or legal status of the human embryo.35 under federal constitutional law, a human embryo, either in vitro or in utero, does not qualify as a "person" entitled to the same rights as postnatal humans.36 state courts have sanctioned this lack of personhood specifically for preimplantation embryos. in york v. jones, the eastern district court of virginia allowed a couple to transfer their ivf embryos to another clinic, finding that the embryos were the couple's property.37 in litowitz, the supreme court ofw ashington enforced an ivf contract requiring the destruc­ tion of cryogenically preserved embryos after five years of storage, implying the embryos had no particular right to life.38 the tennessee supreme court took a less strict view of the persons versus property debate in davis v. davis by finding that human embryos are neither "'persons' [nor] 'property,' but occupy an interim category that entitles them to special respect because of their potential for human life" but having no rights per se.39 in addition, the davis court upheld a father's right to avoid unwanted parenthood, a situation perhaps unique to the advent ofivf technology, as presumably this right could not be exercised post-implantation. 40 thus, despite the continuing and often raging debates on the beginning of life and the rights of embryos, preim­ plantation embryos have been granted no particular legal rights by the federal government. b. statelaw due to the recent vintage of scientific advance (and subsequent debate) relevant to human embryo creation or use, few states have developed policy specifically directed at regulating human embryo research in the current context (ex utero). after the roe v. wade decision of 1973, however, several states passed laws designed to regulate research on fetuses or embryos in utero, and a number of these statutes may extend to affect ex utero, preim­ plantation embryos. 41 35. carly goldstein, note, dipping into uncle sam s pockets: federal funding of stem cell research: is it legal?, 11 b.u. pub. int. l.j. 229, 240 (2002}. 36. roe v. wade, 410 u.s. 113, 158 (1973); davis v. davis, 842 s.w.2d 588, 594-97 (tenn. 1992); see also goldstein, supra note 35, at 246-47. 37. york v. jones, 717 f. supp. 421,426-27 (e.d.va. 1989). 38. litowitz v. litowitz, 48 p.3d 261, 271 (wash. 2002). 39. davis v. davis, 842 s.w.2d 588,597 (tenn. 1992). 40. /d. at 594-95. 41. lori b. andrews, state regulation of embryo research, in 2 p aperscommissioned for the human embryo research panel, supra note 25, at 297. 2005] creating human embryos for research 101 michigan,42 south dakota, 43 and louisiana44 have enacted laws prohibit­ ing research that destroys or harms human embryos, defined by all three states to include ivf preimplantation embryos. louisiana's law is particularly unusual, however, because it goes so far as to defme a preimplantation embryo, or "in vitro fertilized human ovum," as a ''juridical person" until im­ plantation, at which time the embryo presumably loses its personhood and becomes subject to laws governing fetuses in utero.45 minnesota likewise prohibits nontherapeutic research on embryos "conceived either in the human body or produced in an artificial environment", but qualifies its ban to the "living human conceptus" defined by "evidence of life, such as movement, heart or respiratory activity, the presence of electroencephalographic or elec­ trocardiographic activity.'..u; as the preimplantation embryo inarguably has none of these indications oflife, it is difficult to speculate if or how the statute might apply. kentucky permits public funds and facilities for "research into or the performance of in vitro fertilization" but prohibits the use of public medical facilities for procedures that "result in the intentional destruction of a human embryo. •>4? the use of the term "intentional" here is presumably deliberate and implies an understanding that not all embryos created with ivf survive to be implanted or survive the implantation process. it is also significant that the kentucky statute permits ivf research and public funding of that research, provided it does not destroy the embryo.48 finally, no mention of harm to the embryo is included in the statute, which begs the question: are ivf proce­ dures considered an acceptable risk of harm to human embryos? the south dakota and michigan statutes prohibit, respectively, research subjecting embryos to "substantial risk'>49 or research that "substantially jeopardizes the life or health of the embryo. "50 ivf, while generally considered a medical pro­ cedure, might easily be construed as research given the low success rates and lack of data or information regarding the effects ofivf on embryos. 51 to support and facilitate stem cell research, california law has incor­ porated informed consent laws for the donation to research of embryos remaining after fertility treatments. 52 creation of embryos for research is not 42. mich. comp. laws§§ 333.2685, 333.16274 (2004). 43. s.d. codified laws§§ 34-14-16 to -20 (michie 2004). 44. la. rev. stat. ann.§ 9:122 (west 2004). 45. /d. § 9:123 46. minn. stat.§ 145.421-.422 (2004). 47. ky. rev. stat. ann.§ 311.715 (michie 2004). 48. /d. 49. s.d. codified laws§ 34-14-17 (michie 2004). 50. mich. comp. laws§ 333.2685 (2004). 51. see generally van blerkom, supra note 25, at i; div. of reproductive health, dep't of health & human servs., 2000 assisted reproductive technology success rates: national summary and fertiijty clinic reports (dec. 2002), available at hhttp://www.cdc.gov/reproductivehealth/ art/ archivedartpdfs/ ar 1'2000. pdf. 52. cal. health & safety code § 125315 (deering 2004). 102 indiana health law review [vol. 2:93 addressed. a new hampshire statute regulates use of preimplantation em­ bryos by disallowing ex utero growth longer than fourteen days and banning the transfer of embryos to the uterine cavity once they have been used for research ·purposes. 53 iowa, rhode island, and michigan have all enacted statutes prohibiting human cloning via somatic cell nuclear transfer, 54 while missouri prohibits state funding of cloning procedures. 55 these statutes are currently the only laws directly addressing a form of embryo creation. twenty-five states have developed laws for experimentation on fetuses or unborn children.56 however, those that might generally be construed to apply to embryos were not designed to account for preimplantation embryos. they refer to the "live human fetus"57 or "unborn child,"58 "before or after expulsion from its mother's womb," and define the term "fetus" to include an embryo, but do not further define embryo. 59 maine's statute forbids the use of "any product of conception considered live born" for research purposes, but defines "live born" as "a product of conception after complete expulsion or extraction from its mother ... ," suggesting the statute would not apply to embryos created ex utero. 60 considering the recent fate of similar state statutes held by state courts to be constitutionally vague, 61 it is unlikely that many of these statutes would pass muster should they be brought to court. ill. the history of human embryo research policy the use of human embryonic cells in science dates back at least to the early twentieth century. in 1936, scientists used human embryonic brain tissue in attempts to culture the polio virus, and in 1954, the nobel prize in medicine was awarded to three scientists who successfully cultured the virus in human embryonic kidney cells.62 scientific work with embryonic cells continued63 53. n.h. rev. stat. ann.§ 168-8:15 (2004). 54. iowa code§ 7078.4 (2003); mich. comp. laws§ 333.16274 (2004); r.i. gen laws§ 23-16.4-2 (2004). 55. mo. rev. stat.§ 1.217 (2004). 56. andrews, supra note 41, at 297. 57. me. rev. stat. ann. tit. 22, § 1593 (west 2003); mass. gen. laws ch. 112, § 12j (2004); n.d. cent. code § 14-02.2-01 (2003); r.i. gen laws § 11-54-1 (2004). 58. 18 pa. cons. stat.§ 3216 (2003). 59. mass.gen.lawsch.112,§ 12j(2004);n.d.cent.code§ 14-02.2-01 (2003);r.i. genlaws §11-54-1 (2004). 60. me. rev. stat. ann. tit. 22, §§ 1593, 1595 (west 2003). 61. forbesv. napolitano236f.3d 1009(9thcir. 2000); lifchezv. hartigan, 735f. supp 1361 (n.d. ill. 1990). 62. professors. gard, presentation speech for the nobel prize in physiology or medicine 1954 (dec. 10, 1954), in nobel lectures, physiolooy or medicine 1942-1962 (1964), http://www.nobel.se/medicine/laureates/1954/press.html (last modified june 27, 2003) (on file with the indiana health law review). 63. w. p. luckett, the development of primordial and definitive amniotic cavities in early rhesus monkey and human embryos, 144 am. j. anatomy. 149 (1975); j. f. kennedy & b. r. migeon, evidence for the inactivation of an x chromosome early in the development 2005] creating human embryos for research 103 without controversy until the abortion debate reached a fever pitch with the roe v. wade supreme court decision in 1973.64 public concern with the use of aborted fetuses in research and the potential coercion of women to abort to donate to science led many states to enact laws governing the disposition of aborted fetal tissue. 65 the controversy over ex utero embryos as research subjects intensified with the advent of ivf techniques.66 in 1975, the department of health, education and welfare issued its guidelines for federal funding of research using fetal tissue. 67 included in these guidelines was the provision that all grant applications for research using ex utero ivf embryos be approved by an ethics advisory board (eab).68 the 1978 birth of louise brown, the first child born using ivf, led congress to recognize both the imminent demand for this technology and the ethical challenges it would bear.69 in response, an eab was created to draft guidelines for funding research into the development ofivf and the use ofhuman embryos in research in general.70 the eab issued its recommendations in may 1979, which included support for funding research that would both use and create human embryos. 71 the public response to the eab report was largely negative, particularly due to organized protests by religious groups, and the resignation of the secretary of the department of health, education and welfare (hew) in september of the same year. 72 the eab' s charter expired in 1979, effectively ending federal funding for research with human embryos as no board existed to approve requests for funding. 73 a new eab was never convened, and challenges to the funding moratorium by nih and health and human services administrators went unheeded by the reagan and bush administrations. 74 of the human female, 27 am. j. hum. genetics 233 (1975); marvin s. legator et al., aflatoxin: effect on cultured heteroploid human embryonic lung cells, 208 nature 345 (1965); p. a. brunell. separation of infectious varicella-zoster virus from human embryonic lung fibroblasts, 31 virology 732 (1967); i.v. sultanian & g. freeman, enhanced growth of human embryonic cells injected with adenovirus 12, 154 science 665 (1966). 64. andrews, supra note 41, at 297; john c. fletcher, the stem cell debate in historical context, in the human embryonic stem cell debate, supra note 2, at 27. 65. andrews, supra note 41, at 297. 66. green, supra note 6, at 2-3; erin p. george, comment, the stem cell debate: the legal, political and ethical issues surrounding federal funding of scientific research on human embryos, 12 alb. l.j. sci. & tech. 747, 763 (2002). 67. heather boonstra, human embryo and fetal research: medica/support and political controversy, gutimacher rep. on pub. pol'y, feb. 2001, at 3, available at http://www.guttmacher.org/pubs/tgr/04/1/gr()40103.pdf. 68. jd. 69. green, supra note 6, at 2-3. 70. /d. 71. /d.; eab report, supra note 5. 72. green, supra note 6, at 2-3. 73. /d. 74. /d. 104 indiana health law review [vol. 2:93 in 1993, congress passed the national institutes ofhealth revitalization act, which eliminated the requirement of eab approval for human embryo research funding. 15 the nih then convened the human embryo research panel , (herp), to investigate and compile information on the ethics and science of the use of ex utero preimplantation human embryos in research and to recommend funding guidelines for such research. the panel consisted of scientists, physicians, bioethicists, lawyers, political scientists, a sociologist, and.a representative of a sickle-cell anemia organization.76 in 1994, herp published its report, which, like the eab reports before it, recommended federal funding for both the use and creation of human embryos for research purposes, provided a number of ethical principles were maintained. 77 these included informed donor consent, research of high medical significance for which other means of investigation were exhausted, prohibition of financial coercion for embryo donation, and "[ o ]ut of respect for the special character of the preimplantation human embryo", a fourteen-day limit on maintaining embryo growth. 78 president clinton, however, rejected herp's recommendation that funding be permitted for the creation of embryos for research purposes, and in 1996, congress correspondingly passed an appropriations bill containing an amendment, sponsored by representatives jay dickey (r-ak) and roger wicker (r-ms), that banned federal funding of all human embryo research. 79 what was once a de facto moratorium became a legislated one. 80 the dickey amendment did not end the human embryo research debate, however, as the medical promises of stem cell research and therapeutic cloning were too great to be ignored. in 1999, the department ofhealth and human services (dhhs) concluded that the dickey amendment did not apply to embryonic stem cells directly, and that stem cell research is eligible for federal funding if the actual generation of the cells (through the destruction of a human embryo) was not accomplished with federal monies.81 to establish responsible guidelines for funding stem cell research, the nih subsequently assembled a stem cell working group, a team of ethicists, patients, advocates, lawyers, scientists, and physicians, who reported to the advisory committee 75. nationallnstitutesofhealthrevitalizationactofl993,pub.l.no.103-43, 107stat 112 (1993). 76. herp report, supra note 3. 77. ld. at xi. 78. ld. 79. balanced budget downpayment act, i, pub. l. no. i 04-99, § 128, 110 stat. 26, 34 (1996). 80. george, supra note 66, at 765. 81. minutes, national institutes of health, proceedings of the 78th meeting of the advisory committee to the director (june 3, 1999), available at http://www.nih.gov/about/director/minutes699.htm. 2005] creating human embryos for research 105 to the director. 82 president clinton established the national bioethics advi­ sory commission (nbac). after thorough review, the nbac recommended that stem cell research using stem cells obtained from either cadaveric fetal tissue or excess ivf embryos be federally funded. 83 dhhs and nih used these recommendations to establish guidelines (though later withdrawn) for the use of federal funds for stem cell research with ivf embryos that protected these embryos from commerce; induced donation, provided for informed con­ sent, and required extensive procedural oversight. 84 nbac recommendations did not, however, support federal funding of research engaged in the creation of embryos, basing its decision on the fact that, though there may be future compelling scientific reasons to do so, including '<research into the process of human fertilization," currently "embryos remaining after infertility treatment provide an adequate supply of research resources. "85 they also cite "a morally relevant difference between generating an embryo for the sole purpose of creating a child and producing an embryo with no such goal. "86 the election of george w. bush to the white house expectedly begat winds of political change in the moral arena of embryos and research. simul­ taneous with his decision to permit stem cell research only with cell lines exist­ ing prior to august 9, 2001, president bush established his president's council on bioethics (pcb) to further research and debate the issue. 87 the pcb is still investigating the scientific and ethical issues of stem cell research but released a report on human cloning in july 2002.88 the members of the council were divided 1 0-7 against commencing federal funding for cloning for biomedical research (aka "therapeutic cloning'"), with those opposed citing a belief that is it "immoral to create human embryos for purposes that are foreign to the embryos' own well-being and that necessarily require their destruction."89 iv. the future of human embryo research policy the advent of in vitro fertilization (ivf) and other assisted reproductive technologies (art) introduced a novel moral dilemma and legal challenge regarding the significance and rights of an embryo conceived by the union of 82. goldstein, supra note 35, at 238; rich mcmanus, stem cell guidelines still pending director's advisors bat 6 for 7, nlli rec. (nat'llnst. of health, bethesda, m.d.), jun. 29, 1999, available at http://www.nih.gov/newsinih-record/06 _ 29 _ 99/story02.htm. 83. nbac report, supra note 5. 84. national institutes ofhe&lth guidelines for research involving human pluripotent stem cells, 65 fed. reg. 51,976 (effective aug. 25, 2001) (withdrawn on nov. 14, 2001, 66 fed. reg. 220). 85. nbac report, supra note 5, at 5. 86. id. 87. remarks, supra note 32. 88. the president's councn..on bioethics, human cloning and human dignity: an ethical inquiry (july 2002), available at http://www.bioethics.gov/reports/ c1oningreport/pcbe _cloning_ report. pdf. 89. id. at 201. 106 indiana health law review [vol. 2:93 sperm and egg in a petri dish that is not yet implanted into a woman's uterus and as such cannot become a human being. the medical potential of stem cell research seems to mitigate ethical concerns over embryo destruction in the minds.ofmost, but the question of creating to destroy seems more disconcert­ ing. is it possible to permit and adequately regulate the creation of human embryos for research purposes only, with no intent to endeavor to create a human being? does such an act violate an inflexible national moral code? in this part, i will attempt to address these questions. a. is the creation of human embryos for research purposes legal? . as discussed in part iii, current federal law does not criminalize the creation of embryos for research. additionally, no provision currently quali­ fies preimplantation embryos as persons nor endows them with rights ensured to all humans under the constitution, while state courts have held that preim­ planted human embryos, though perhaps worthy of special moral considera­ tion, have no specific legal rights. 90 thus both the creation and use of preim­ plantation embryos in research is legally permissible under federal law, and consequently, privately funded, largely unregulated human embryo research continues here in the u.s.91 individual state laws, where they exist, differ in their permitted treatment of human embryos. with the exception of louisiana, no state laws proscribe the creation of embryos for research using traditional ivf technology (a few have banned the use of scnt to create cloned embryos92). thus the states have so far chosen not to prohibit creating embryos for research, perhaps to avoid overlap with creation of embryos for ivf and concerns that ivf proce­ dures might be construed as experimental. kentucky's statute, in particular, seems aware of this potential overlap and could even be interpreted to permit creation of embryos for research provided the research did not destroy the embryo.93 a lack of prohibition of harm to the embryo in the kentucky statute, contrasted with the conspicuous proscription ofharm to the embryo in the michigan, south dakota, and louisiana statutes94 again provokes an inquiry into whether, in the latter three states, ivf procedures could be con­ sidered injurious to a preimplantation embryo. relevant to the purpose of this 90. york v. jones, 717 f. supp. 421,426-27 (e.d.va. 1989); litowitz v. litowitz, 48 p.3d 261, 271 (wash. 2002); davis v. davis, 842 s.w.2d 588, 597 (tenn. 1992). 91. for examples of american companies engaged in stem cell and therapeutic cloning research see today's stem cell research, stem cell companies: stem cell research companieslist,athttp://www.stemnews.com/stem-cell-companies(lastvisitedapr.19,2005) (on file with the indiana health law review). 92. iowacode§707b.4(2003);ml:ch.comp.laws§333.16274(2004);s.d.codified laws§§ 34-14-26 to -28 (michie 2004); ark. code§§ 20-16-1001 to -1003 (michie 2003). 93. ky. rev. stat. ann. § 311.715 (michie 2004). 94. la. rev. stat. ann. § 9:129 (west 2004); mich. comp. laws§§ 333.2685, 333.16274 (2004); s.d. codified laws§§ 34-14-16 to -20 (michie 2004). 2005] creating human embryos for research 107 discourse is the following question: given the inherent risks and incomplete understanding of ivf mechanisms, is creation of an embryo itself injurious to the embryo, and thus illegal in at least three states? that is a question perhaps best answered by the courts. still it is clear from the statutes that no state intends to interfere or hamper nf as a practice, and so the creation of embryos by and large remains legal. b. is the creation of human embryos for research purposes ethical? there currently seems to be no overriding pressure in this country to halt the creation of human embryos for treating infertility, despite the fact that the majority of these embryos will die. it appears that in the minds of the public, the benefits of ivf-the chance for an infertile couple to reproduce, a feat considered by most to be of fundamental value to human life-outweigh any moral reservations regarding the loss of excess embryos. this is not to suggest that there are no objections to nf or the in vitro creation of embryos; on the contrary, several groups remain in objection, most notably the catholic church.95 but in general, the widespread availability ofnf technologies sug­ gests that the public accepts nf as a scientific and medical achievement of merit, not science gone awry. it is also apparent, however, that the ethical objections to the destruction of embryos created in vitro is not as readily mitigated by the use of embryos for research purposes. 96 the willingness of the public (and thus the legislature and courts, inasmuch as they reflect the public moral fabric) to accept the use of such embryos for research may depend on the medical value that is assured from the research. those who create a distinction, as did the nbac, between creating embryos for implantation and creating embryos for research misinterpret the purpose of nf technologies. ivf and other assisted reproductive technolo­ gies, not all of which involve the ex utero creation of an embryo, are designed to combat infertility, not to create life. even when conception occurs in a petri dish, a mother's womb is necessary to bring that embryo to term, to allow it to gestate and develop the organs, tissues, and sentience it needs to become a human child. this is not to suggest that the preimplantation embryo has no value; on the contrary, the existence of controversy reflects the moral signifi­ cance and high regard that the public does, in fact, hold for these embryos. yet arguably, nf technology may never have come into being, or at least have become accepted practice, if it were not directed at the treatment of infertility. the purpose of ivf was never to create life per se, but to allow couples a chance at conception. and if it is ethical to create embryos to treat infertility, a purpose that is not therapeutic and can even be harmful to the 95. americancatholic.org. web-exclusives: stem-cell research and the catholic church, athttp:/lwww.americancatholic.orginewsistemcellldeflwltasp(lastvisitedapr.l7,2005)(on file with the indiana health law review). 96. herp report, supra note 3. 108 indiana health law review [vol. 2:93 embryo itself, it ought to follow that it is ethical to create embryos to treat parkinson's disease or other devastating illnesses. however, human embryos cannot,be considered merely as a means to an end and, in all cases (including infertility treatments), are due some measure of respect for their potential to become human beings. thus federal oversight of all human embryo research is not only wise scientifically speaking, but is also ethically necessary to uphold the respect due preimplantation embryos. furthermore, if ivf is to remain an accepted medical practice, then research into improving this technology is necessary to preserve not only the moral respect due human embryos, but also respect for human fertility and the process of childbirth, particularly considering the potential hazards imposed on a woman's body by current ivf methods. high quality, peer-reviewed research is required to advance this field in a clinically acceptable manner, and the creation of human embryos specifically for this research should be a compulsory component for adequate scientific controls. the creation of human embryos ex utero currently requires the donation of human eggs, or oocytes.97 egg donation invokes both ethical and scientific issues. the current methods used to obtain eggs from the ovaries entail some risk and a great deal of discomfort, and arguably relatively few women would donate without some incentive, be it financial or a direct benefit to themselves or their loved ones. a dearth of oocytes then might induce scientists to coerce women to donate with larger financial compensation than ethically reasonable. however, local institutional review boards could manage such issues on a proposal-by-proposal basis, and there is no reason to suggest that they could not regulate appropriate monetary compensation for anonymous egg donation. directed or non-anonymous donation of oocytes may prove ethically more challenging. first, donation for the purpose of research avoids maternity issues provided the embryos are never transferred to a womb, and any legisla­ tion permitting the creation and subsequent use of human embryos in research should prohibit such transfer. there are legitimate concerns, however, that women might be unduly pressured or influenced by family, clinicians, or others to donate eggs to develop treatments for loved ones.98 the risks im­ posed by egg stimulation and retrieval procedures warrant careful considera­ tion of informed consent procedures, particularly if the egg donation is not intended to directly benefit the donor, as it is in ivf. also, issues of owner­ ship may arise if donors intend or wish to restrict the products of their gametes for a particular individual or group. 97. a recent scientific report suggests that stem cells can be induced to become oocytes, potentially sidestepping donation, but the experiments were perfonned with mouse embryonic stem cells and no guarantee exists that the procedure would work with human embryonic stem cells. karin. hubner et al., derivation of oocytes from mouse embryonic stem cells, 300 science 1251 (2003). 98. suzanne holland, beyond the embryo: a feminist appraisal of the embryonic stem cells, in the human embryonic stem cell debate, supra note 2, at 73. 2005] creating human embryos for research 109 yet, consider the case of molly nash. 99 in 2000, jack and lisa nash gave birth to a baby boy, adam, conceived through ivf. the embryo that became adam was chosen using preimplantation genetic diagnosis to select for an embryo that was both a transplant match for and free from fan coni anemia, the genetic disease afflicting young molly that results in bone marrow failure and often leukemia.100 stem cells from adam's umbilical cord were transferr~ ed to molly and have improved her condition.101 is it more ethical then to give birth to a baby and harvest its stem cells than to allow parents to create an embryo with ivf and use it to create stem cells to treat an ill child? if one considers the destruction of a preimplantation human embryo the moral equi­ valent of murder, the answer is simple. if not, it seems any measure of harm to a conscious, postnatal child is worse than disaggregating an embryo com­ posed of a tiny cluster of cells. still there are those who object to the use of human embryos in research at all, regardless of how or why they are created, based on the belief that embryos are the moral equivalents of postnatal human beings.102 however, the majority of americans do not subscribe to this viewpoint;103 and as bioethicist erik parens points out, this type of moral distinction typifies "a particular set of beliefs that citizens in a democracy are not obliged to accept."104 still it appears that americans are not indifferent toward embryos but consider them with some deference.105 the development of legislation concerning stem cell and therapeutic research, including the issues of embryo creation for research, should correspondingly reflect the diverse beliefs of u.s. citizens, rather than 99. genetic selection gives girl a brother and a second chance, cnn.com, oct. 3, 2000, athttp://www.cnn.com/2000/heal 1h/1 0/03/testube.brother/index.html (last visited apr. 17, 2005) (on file with the indiana health law review). 100. fanconi anemia research fund, inc., about fanconi anemia: what is fanconi anemia?, at http://www.fanconi.org/aboutfa/f a.htm (last updated aug. 1, 2004) (on file with the indiana health law review). 101. rhonda rowland, genetic testingofembryos raises ethical issues, cnn,com,june 27, 2001, at http://www.cnn.com/200 i !heal 1h/06/27/embryo.testing/ (last visited apr. 17, 2005) (on file with the indiana health law review). 102. a series of polls conducted on the topics of stem cell research and human cloning reveals that, while often a majority of respondents favor stem cell research using human embryos, typically 30-40 percent of respondents oppose this research outright. furthermore, according to a los angeles times poll conducted from jan. 30-feb. 2, 2003, only 11 percent of respondents are in favor of eliminating all restrictions on human cloning research. pollingreport.com, american scene: science and nature, at http://www.pollingreport.com/ science.htm (last visited apr. 17, 2005) (on file with the indiana health law review). 103. jeffrey m. jones, update: americans' views on stem cell research, gaw.n> pou., august 14,2001, athttp://www.gallup.com/content/login.aspx?ci=4792 (last visited apr. 17, 2005) (on file with the indiana health law review). 104. erik parens, on the ethics and politics of embryonic stem cell research, in the human embryonic stem ceil debate, supra note 2, at 37, 40. 105. see generally pollingreport.com, american scene: science and nature, at http://www.pollingreport.com/science.htm (last visited apr. 17, 2005) (on file with the indiana health law review). 110 indiana health law review [vol. 2:93 the more vocal and politically active religious interests or the silent but potentially profit-driven interests of infertility clinics. nonetheless, widespread public acceptance does not necessarily render a scientific technique ethical. public demand for medical aid is capable of overshadowing ethical considerations. this has occurred with ivf and other assisted reproductive technologies, which undisputedly carry a measure of risk to the children born of these technologies106 and, as discussed, engage in embryo creation with implicit understanding that many embryos will be de­ stroyed. in fact, more careful consideration of the ethics of art is most likely warranted and has been undertaken recently by the pcb in its march 2004 report. 107 likewise, careful consideration of embryo creation for research pur­ poses is necessary and should be ongoing as the science of stem cell research and therapeutic cloning advance because advance they will, either within or outside of the united states. c. missed opportunities: federal funding of human embryo research federal oversight of human embryo research and its application should be mandated for several reasons. first, given the rapid development of novel technologies, a lack of regulation and oversight may well lead to unexpected scientific consequences. concerns with human cloning were rightly inten­ sified by scientific evidence that dolly the sheep and other animal clones may have health problems related to the cloning process.108 the effects of ivf on embryos have not been fully studied, 109 and as neither somatic cell nuclear transfer nor in vitro fertilization to create embryos qualify as treatments on a living patient, they are not currently subject to review by the food and drug administration or other regulatory agency.11° federal funding will ensure these technologies undergo peer review to evaluate their scientific quality and value and should dramatically increase the number of studies undertaken to assess whether these technologies adversely affect embryos. such knowledge would enhance both the practice of treating infertility and our understanding 106. for example, the higher incidence of multiple gestation leads to greater probability of newborn health problems. dep't of health & human servs., 2001 assisted reproductive technology success rates: national summary and fertiuty clinic reports 20 (dec. 2003), available at http://www.cdc.gov/reproductivehealth/artoi/pdf/ art200 i. pdf. 107. the president's councr.onbioetidcs, reproduction andresponsffiility the regulation of new biotechnologies (mar. 2004), available at http://www.bioethics.gov/ reports/reproductionandresponsibility/index.html. 108. bridget m. kuehn, goodbye, dolly: first cloned sheep dies at six years old, javmanews, apr. 15, 2003, at http://www.avma.orglonlnews/javma/apr03/030415f.asp (last visited apr. 17, 2005) (on file with the indiana health law review). 109. van blerkom, supra note 25, at i. ii 0. am. ass'n for 1he advancement of sci., regulating human cloning (apr. 3, 2003 ), available at http:/ /www.aaas.orglspp/cstc/issueslcloningreport.pdf. 2005] creating human embryos for research ill of embryonic development, and by improving ivf technology, might well lead to a decreased number of embryos needed for both the clinic and in research. secondly, federal oversight ensures that the ethics of both using and creating human embryos are always carefully considered. though their re­ commendations were subsequently discarded, the various national bo~s appointed to review the ethics of emerging technologies reflect this effort.111 and as discussed in the next section, a glance across the pond at the u.k.'s human fertilisation and embryology authority reveals a unique regulatory agency that endeavors to maintain ethical standards while permitting embryo creation. lastly, with federal funding of human embryo research, the united states can maintain its status as a leader in scientific and medical advances. federal monies will both allow these rapidly developing and potentially revolutionary technologies to bloom here at home and allow the u.s. system of scientific peer-review to shine as a model for careful and deliberate con­ sideration ofboth scientific merit and ethical concerns. without federal fund­ ing, the next decade may witness talented u.s. scientists who are dedicated to infertility or stem cell research departing for other countries; the continued use of non-peer-reviewed, potentially lesser quality research in our clinics; and the absence of recourse to hinder those who would violate ethical principles due human embryo research by, for example, attempting human reproductive cloning.· furthermore, private investors in this research may be difficult to find, as the promise of the medical technologies that may develop are too far down the road to warrant capitalization.112 this too, will dramatically slow the progress of human embryo research in the united states, and we can only watch as other nations become the world's new scientific leaders. all of the recommendations published by federally commissioned ethics groups clearly outlined mechanisms for maintaining the respect due preim­ plantation human embryos during their use in scientific research. 113 these groups were diverse in their opinions and interests and presumably approached their task as impartially as possible. though their recommendations differed somewhat, arguably due to changes in the political climate, their valuable expertise and concerted efforts to develop appropriate regulations appear to have been consistently ignored by politicians bowing to pressures from an unyielding minority. for this reason, the efforts of these ethics review groups represent multiple missed opportunities for the united states to enact legislation concordant with our historical and current legal treatment and moral consideration of preimplantation human embryos. 111. herpreport,supranote 3; eab report,supra note 5; nbac report,supranote 5. 112. luke timmerman, a puzzling investment stem-cell research is exciting, but not to investors, who see ethical risks, an expensive, unpredictable product and a sketchy business model with an unknown future, seatile times, feb. 22, 2004, at el. 113. herpreport,supranote 3, at 100-14;nbacreport,supranote 5, at65-74. 112 indiana health law review [vol. 2:93 d. the hfea and the united kingdom example , '.a survey of eleven democratic nations, including australia, canada, and nirie· ·european countries, revealed that only one, norway, has· banned all human embryo research.114 great britain, a nation typically politically allied with the united states, is one of the most liberal nations in terms of permitting the. use of human embryos in research. approximately seventy percent of u.k..citizens support the use of human embryos ''for medical research to find treatments for serious diseases and for fertility research",115 and the govern­ ment's policy reflects this position. what, then, is different about their approach? in 1990, the united kingdom established the human fertilisation and embryology authority (hfea) to oversee and regulate all scientific and medical use of human embryos. 116 all human embryo research proposals, regardless of their source of funding, must be approved and licensed by the hfea.m approval is contingent on both the purpose and the necessity of the research; only proposals that the hfea deems necessary to advance one of its purposes eligible for licensing will be authorized. 118 these purposes include promoting advances in infertility treatment, increasing knowledge of causes of congenital disease and miscarriage, developing more effective techniques for contraception, developing methods for detection of genetic or chromoso­ mal abnormalities in preimplantation embryos, advancing understanding of embryonic development, increasing knowledge of serious disease, and en­ abling such knowledge to be applied in developing treatments for these diseases. 119 from this list, it is apparent that the original goals of the hfea were to facilitate· human embryo research that would improve infertility treatment, enhance family planning, and increase our understanding of embryological disorders. the latter three purposes, added in 2001, were enacted to facilitate stem cell research120 and imply ·that this use of human embryos is· ethically acceptable in the united kingdom. however, researchers wishing to derive stem cells from human embryos must justify why embryonic stem cells are to 114. andrews, supra note 41, at 297. 115. seven in ten members of the public support the use of embryos for medical research, mori, apr. 8, 2003, at http://www.mori.com/polls/2003/amrc.shtml (last visited apr. 17, 2005) (on file with the indiana health law review). 116. press release, human fertilisation and embryology authority, suzi leather, chair of the human fertilisation and embryology authority clarifies the authority's role in regulating stem cell research (sept. 11, 2002), at http://www.hfea.gov.uk/pressoffice/archive/85775462 (last visited apr. 17, 2005) (on file with the indiana health law review). 117. human fertilisation and embryology act, 1990, c. 37 (eng.), available at http://www.legislation.hmso.gov.uk/acts/actsl990/. 118. !d. 119. id. 120. id 2005] creating human embryos for research 113 be used, rather than other types of stem cells, provide detailed information on what happens to the stem cells throughout the project, and place a sample of all cell lines established in the mrc stem cell bank. 121 scientists also are prohibited from transferring stem cell lines to third parties,. so that the hfea may maintain a complete inventory and research trail. 122 prior to granting new licenses or allowing a change in an existing license, the hfea inspects all research facilities to ensure appropriate facili­ ties, security, and mechanisms for informed consent without coercion and con­ fidentiality are in place. the hfea also regulates the separation of embryos for research and for treatment, methods for obtaining embryos, the length of time such embryos may be maintained in culture (fourteen days), and the proper procedures for embryo destruction. further, for a license to be granted, the proposal must pass a local research ethics committee review and be peer­ reviewed to determine the following: 123 1. whether the research fulfills the categories for which embryo research is permitted; 2. the importance of the research in the field; 3. whether the research has been done before; 4. whether the use of human embryos is justified; s. the suitability of the methods to be used; 6. the proposed length of the study; 7. the applicant's qualifications}24 in short, the use ofhuman embryos in the united kingdom is not taken lightly. the rigorous process of review and licensing endeavors to maintain a level of integrity in the science and respect for the embryo by limiting its use. the unique ·and most controversial feature of the hfea regulations, though, is the authorization of the creation of human embryos for research purposes.125 yet within its extensive oversight framework, the hfea can en­ sure medical and ethical standards are maintained in the creation of embryos, whether for research or for infertility treatment it has established mechanisms to ensure informed consent before gamete donation and before use or storage of embryos.126 it currently mandates anonymous egg donation and requires that donors be informed they relinquish all control over future use of the embryos and any products (stem cells) derived from these embryos.127 as ruth deech points out, "[i]n this area of medicine [sic] for, it is vital that 121. id. 122. id. 123. human fertilisation and embryology act, 1990, c. 37 (eng.), available at · http://www.legislation.hmso.gov.uk/acts/acts1990/. 124. /d. 125. id.; see also peter moore, are stem cells the answer? a global struggle to deal with human es cells, hhmi buuetin, mar. 2002, at 16. 126. human fertilisation and embryology act, 1990, c. 37 (eng.), available at http://www.legislation.hmso.gov.uklacts/acts1990/. 127. ld. 114 indiana healm law review [vol. 2:93 patients understand the implications of their treatments, the ethical and emotional sensitivities ... [t]he code of practice requires clinics to give such information to patients!'128 though united states' clinics typically provide some' measure of informed consent, patients, relevant lawsuits, and the dis­ parate decisions of the courts129 suggest that a federally organized uniform code of informed consent might benefit both nf patients and research embryo donors. the hfea also endeavors to protect patients by certifying that clinics ''undertake research and sufficient training before treating patients with a new technique."130 though certainly the united states' judicial system offers a mechanism to redress medical malpractice, the hfea's proactive stance offers a better protection of patients, and one that is not obviously present in u.s. clinics dealing with desperate would-be parents. the opportunity exists for clinics to unintentionally put patients at risk when they are eager to try a new technology for the sake of science or if medical personnel become emotionally invested in helping an infertile couple conceive. with oversight, however, the development of new techniques, such as the creation of embryos to harvest stem cells for directed donation, can be restricted to the research phase until deemed ready for clinical practice. in addition, the strict data reporting and collection methods employed by the hfea may also prove valuable in asses­ sing the impact of such technologies on the health of women and children involved. 131 despite the freedoms in human embryo research granted scientists and clinicians in the united kingdom, even the hfea has been criticized as "a barrier to progress. "132 perhaps some scientists will never be satisfied when their actions are regulated in some form. yet the sensitive nature of embryo research, particularly the creation of embryos for research, compels careful ethical and scientific contemplation, the employment of guidelines and regula­ tions that protect ethical standards, and an impartial body outside the clinical setting to make sure those standards are upheld. in the united kingdom, the hfea serves as this impartial body for all human embryo use and creation and thus far appears to have served it well. time will tell if the permitted and funded creation of embryos bears the promised medical fruits and renders great britain the international leader of scientific research in human embryology, therapeutic cloning, and stem cell research, but their open-mind­ ed, non-ideological but respectful approach certainly will grant them a head128. ruth deech, a fine conception: the experience of the human fertilisation and embryology authority (hfea), 85 euro. j. obst. & gyn. & reproo. biol. 3, 5 (1999). 129. york v. jones, 717 f. supp. 421 (e.d.va 1989); davis v. davis, 842 s.w.2d 588 (tenn. 1992); litowitz v. litowitz, 48 p.3d 261,271 (wash. 2002). 130. deech, supra note 128, at 5. 131. p. doyle, the u.k. human fertilisation and embryology authority. how it has contributed to the evaluation of assisted reproduction technology, 15(1) int. j. tech. assess. health care 3 (1999). 132. deech, supra note 128, at 5. 2005] creating human embryos for research 115 start. meanwhile, as ruth deech observes, "[t]he experience of the hfea is that it is possible to provide effective controls, as long as close co-operation is maintained with licensed clinics, professional and patient groups."133 the regulation ofhuman embryo research, however, does not require a unique regulatory body like the hfea. the current system in the united states for managing and regulating scientific research is highly effective and collaborative. we might look to the future successes of the hfea, however, and realize that the ethical and regulatory issues of human embryo research, including the creation of embryos solely for research purposes, are manageable and, due to the need to respect human life in all its forms, best under the public microscope rather than under the influence of the profit-driven private sector. nonetheless, due to the public interest and media frenzy currently surrounding the sensitive issues of cloning and stem cell research, a centralized national review board under the auspices of the nih and the dhhs might be prudent at this time to maintain public awareness until the benefits of this research can be clearly delineated and effective ethical management demonstrated. once accomplished, review of human embryo research might be then relegated to local irbs. the medical significance of the research ought to preclude a repeat of the failed eab of the late 1970s. v. conclusions widespread public medical demand for the medical benefits of embryo­ nic stem cells and therapeutic cloning, like ivf and art, may lead to a general acceptance of the creation of embryos in vitro with the intent to dis­ aggregate them and end their potential to become fully nascent human beings. thus to allow the opinions of all u.s. citizens on this highly controversial issue to be heard and represented, to maintain respect for the human embryo, and to avoid inappropriate use and creation of embryos, federal funding and oversight of human embryonic research should be undertaken. it is important to consider and carefully weigh the medical and ethical significances of creating embryos to pursue research. it is perhaps unethical not to pursue this research in terms of both scientific standards and advancing medicine to treat ravaging diseases affecting millions. it is also plausible that unmeasured embryo creation could profoundly diminish our cultural regard for the signifi­ cance of human individuality. yet the experience of the united kingdom's human fertilisation and embryology authority demonstrates that the ethics of embryo creation are manageable, and the hfea provides a rudimentary framework that might be adapted in the united states under the auspices of the nih and dhhs. 133. /d. mandating the gardasil vaccine: a constitutional analysis kyra r. wagoner* table of contents i. introduction ..................................................................................... 404 ii. background ...................................................................................... 407 a. human papillomavirus ............................................................. 407 b. gardasil .................................................................................... 409 iii. it is constitutional for states to mandate the gardasil vaccine ......................................................................................... 412 a. cases establishing states' authority to mandate vaccination .............................................................................. 412 b. application of jacobson today ................................................. 415 1. an "all or nothing" approach is not the best approach to take when thousands of lives may be saved by the vaccine in the united states .................... 417 2. since safety concerns and myths have been addressed, the number of vaccines children currently receive should not detract from the fact that gardasil could save thousands of lives .............................................................................. 418 3. regardless of the fact that hpv could be reduced through behavior modification, gardasil should be viewed in the same light as the vaccine for hepatitis b ......................................................................... 420 4. mandating gardasil will not encourage children to engage in sexual activity .............................................. 422 5. mandating gardasil is in the child's best interest.. ........... 423 6. states should mandate gardasil to ensure that the vaccine's cost is covered so that the highest number of females have access to the vaccine ............... 424 7. vaccination programs save money in the long-run ......... 424 8. mandatory vaccination programs ensure universal coverage thereby creating the most effective way to prevent diseases such as hpv and cervical cancer ....... 425 9. many states have begun measures to mandate gardasil ..... ........................................................................ 426 404 indiana health law review [vol. 5:403 iv. it is constitutional for the state to deny parents' religious and philosophical exemptions to the gardasil vaccine ......................................................................................... 428 a. cases discussing exemptions to vaccinations ......................... 428 1. medical exemptions ............................................................ 428 2. philosophical exemptions ................................................... 429 3. religious exemptions ........................................................... 429 b. it is constitutional for the state to deny parents non-medical exemptions to the gardasil vaccine ................. 431 v. conclusion ........................................................................................ 435 i. introduction vaccinations were developed in the late eighteenth century to prevent smallpox.1 since then, vaccinations have become an important component of public health efforts and the most cost-effective and widely-used public health measure to control the spread of epidemic diseases such as smallpox, measles, mumps, rubella, diphtheria, and polio. 2 when the centers for disease control and prevention ("cdc") published a list of the great public health achieve­ ments for the united states from 1900 to 1999, vaccination was the first achievement listed. 3 * j.d. candidate, 2008, indiana university school of lawindianapolis; b.s., 2002, butler university. 1. james g. hodge, jr. & larence 0. gostin, school vaccination requirements: his­ torical, social, and legal perspectives, 90 ky. l.j. 831, 833 (2002). see also rick westhead, imagine, a vaccine, toronto star, aug. 12, 2006, at f 1 (it was dr. edward jenner who first, noticed that dairymaids who had come down with cowpox from cows appeared to be immune from catching smallpox . . . . on may 19, 1796, jenner scratched the arm of a local boy and dropped in rivulets of cowpox pus he had taken from a blister on the hand of a dairy worker. several months later, jenner scratched the boy's arm with deadly pus he had taken from a smallpox victim. the boy didn't get sick and jenner published the results of the [first] successful vaccination. /d. interestingly, the word vaccination is rooted in the latin word vacca which means cow.). 2. hodge, jr. & gostin, supra note 1, at 833. the extensive use of vaccines has eradi­ cated smallpox worldwide and has eliminated wild-type polio from the western hemisphere. as a result, smallpox vaccination has been discontinued. according to the world health or­ ganization, the eradication of polio could occur in 2007. andrew zoltan, note, jacobson revis­ ited: mandatory polio vaccination as an unconstitutional condition, 13 geo. mason l. rev. 735, 735 (2005). 3. nat'! immunization program, cdc, achievements in public health, 1900-1999: impact of vaccines universally recommended for children united states, 1990-1998, 48 morbidity & mortality wkly. rep. 243, 243-48 (1999), available at http://www.cdc.gov /mmwr/preview/mmwrhtml/ 00056803.htm (last visited mar. 20, 2008). 2008] mandating the gardasil vaccine 405 vaccination programs are supported by state legal requirements as well as federal funding and oversight.4 every state has mandatory vaccination laws that require children attending schools to be vaccinated prior to enrollment, un­ less they are eligible for various medical, religious, or philosophical exemp­ tions. 5 children that have not been vaccinated may not be permitted to attend school, and the parents or guardians who failed to vaccinate them may be sub­ ject to civil fines, and criminal penalties, though rarely applied, may be im­ posed against them. 6 although incidents of communicable disease among children have sig­ nificantly decreased since the implementation of mandatory vaccination laws, strong opposition from parents and "antivaccinationists" still exists. 7 manda­ tory vaccination programs have been challenged as: "(1) inconsistent with the federal constitutional principles of individual liberty and due process, (2) an unwarranted governmental interference with individual autonomy, and (3) an infringement of personal religious beliefs under the first amendment. "8 more­ over, some opponents of mass vaccinations also fear harmful effects arising from the introduction of foreign particles into the body, while others believe that vaccinations actually spread disease.9 the debate grew more intense in june of2006 when the food and drug administration ("fda") approved the use of gardasil. 10 gardasil is the first vaccine for females that prevents against four strains of the human papillomavi­ rus ("hpv"), which can cause genital warts and lead to cervical cancer.11 hpv is the most common sexually transmitted disease ("std") in the united states with approximately 6.2 million people acquiring hpv annually. 12 moreover, cervical cancer is the second leading cause of cancer deaths in women, claiming 270,000 lives annually worldwide, including 3700 deaths in the united states. 13 in order for gardasil to be one hundred percent effective in preventing the genital warts and cervical cancer caused by certain types ofhpv, a woman must not have been exposed to the virus previously. 14 accordingly, the fda "has 4. hodge, jr. & gostin, supra note 1, at 833. 5. /d. 6. /d. 7. /d. at 834. 8. /d. 9. !d. 10. see generally merck & co., inc., gardasil informational pamphlet (2006) [here­ inafter gardasil pamphlet] ( gardasil' s scientific name is quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine.). 11. maureen killackey, facts about hpv vaccine need to be clarified, albany times union, july 6, 2006, at aio [hereinafter killackey]. 12. ctr's for disease control & prevention u.s. dep't of health & human services, hpv vaccine questions and answers (2006), http://www.cdc.gov/std/ hpv/stdfact-hpv -vaccine.htm [hereinafter cdc, hpv answers] (last visited mar. 20, 2008). 13. editorial, major breakthrough in women's health, grand rapids press, aug. 29, 2006, at as [hereinafter major breakthrough]. 14. killackey, supra note 11, at a10. 406 indiana health law review [vol. 5:403 approved gardasil's use for females age 9 to 26,"15 and the cdc has recom­ mended that the gardasil vaccination be made available to women ages eleven to twenty-six years. 16 these facts and their social implications have startled many parents. the family research council and focus on the family, both conservative christian organizations with strong evangelical christian affiliations, oppose "anything they believe promotes premarital sex."17 additionally, many "[p]ro-family groups are united in believing that parents should decide what is best for their children."18 these groups believe that the government should not be permitted to force an individual to do something simply because it is potentially benefi­ cial.19 in support of this statement, linda klepacki, a sexual health analyst at focus on the family, commented: "we support widespread distribution of the vaccine, but we oppose mandatory vaccination."20 similarly, moira gaul, a policy analyst for the family research council, stated: "instead of requiring mass vaccination, the government should allow parents to be the primary deci­ sion maker for their children's health, and parents should receive all of the in­ formation on the vaccine's risks and benefits to be able to make an educated decision .... "21 since several groups feel that mandating gardasil is an in­ fringement on children's and parents' freedoms, it is important to examine the public health benefits derived from the vaccine before making a decision as to whether hpv vaccinations should be mandatory.22 this note will first detail the startling statistics on hpv and describe what the gardasil vaccine entails. next, this note will examine cases that have up­ held a state's power to mandate vaccination, as well as cases that have war­ ranted exemptions to vaccination. this note will then conclude with an argument that it is constitutional for states to mandate that girls receive the gardasil vaccination prior to entering school due to the overwhelming public health benefits the vaccine provides. the argument will also explain that it is not constitutionally required for states to provide non-medical exemptions to the gardasil vaccination. 15. major breakthrough, supra note 13, at a8. 16. eric ladley, political pressure could limit gardasil, 25 meoao news 8, aug. 1, 2006, at 10 [hereinafter ladley]. 17. john simons, merck's $4 billion pr problem, fortune, june 5, 2006, http:/ /money.cnn.corn/2006/06/02/news/companies/pluggedin _ fortune/index.htm [hereinafter simons] (last visited mar. 20, 2008). 18. peter sprigg, op. ed., a promising vaccine ... but gardasil should not be mandatory, wash. times, july 17, 2006, at al7 [hereinafter sprigg]. 19. see id. 20. cheryl wetzstein, 1st hpvvaccine ok'd, washington times, july 18,2006, ata2. 21. ladley, supra note 16, at 10. 22. hodge, jr. & gostin, supra note 1, at 834. 2008] mandating the gardasil vaccine 407 ii. background a. human papillomavirus a common misconception of hpv is that it can only be spread through sexual intercourse. indeed, hpv can be spread by contact with the scrotum, vagina, penis, or anus.z3 hpv can, however, also be transmitted through skin­ to-skin contact.24 recently, a scientist even discovered hpv under the finger­ nails of young men.25 dr. laura koutsky, an epidemiologist at the university of washington, stated, "the presence ofhpv under fingernails at the very least suggests another possible route of transmission .... it's an additional route of infection. "26 in 2000, the henry j. kaiser family foundation conducted a survey in which seventy percent of american adults said that they had never heard of hpv, 27 even though hpv is the most common sexually transmitted disease in the united states. 28 at least one-half of all sexually active people will get hpv at some time in their lives.29 each year, approximately 6.2 million new hpv infections occur in the united states alone. 30 hpv is most common in young women and men who are in their late teens and early twenties. 31 of the ap­ proximately six million new cases ofhpv in the united states every year, it is estimated that seventy-four percent ofthem occur in fifteen to twenty-four year olds. 32 however, eighty percent of women will contract hpv by the age of fif­ ty.33 there are more than a hundred types of hpv, most of which are harm­ less. 34 of the many types ofhpv, nearly forty types ofhpv can infect the ge­ nital areas of men and women.35 unlike most hpv types, which cause no 23. see cdc, hpv answers, supra note 12. 24. !d. 25. tom paulson, new riskv discovered for hpv virns found under men's fingernails, pointing to more ways of it spreading, seattlepost-lntelligencer, aug. 1, 2007, at bl. 26. !d. while no evidence exists supporting the contention that someone can get hpv from a handshake, this recent finding of hpv under the fingernails shows that scientists have more to learn about exactly how the virus is transmitted. !d. 27. wetzstein, supra note 20, at a2. 28. ayana mathis, the ultimate std prevention, glamour, nov. 2006, at 114 [hereinafter mathis]. 29. cdc, hpv answers, supra note 12. 30. gardasilpamphlet,supranote 10. 31. !d. 32. !d. 33. erin allday, cervical cancer vaccine approved: sexually transmitted disease treatment raises ethics debate, san francisco chron., june 9, 2006, at ai. 34. karl stark, trading shots over a vaccine: merck and glaxosmithkline are in fierce competition to develop the world's top cervical-cancer immunization, philadelphia inquirer, july 8, 2007, at cl. 35. cdc, hpv answers, supra note 12. 408 indiana health law review [vol. 5:403 symptoms and go away on their own, hpv types that infect the genital areas can cause genital warts.36 some types ofhpv, about fifteen to twenty types, can infect a woman's cervix and cause the cells to change. 37 over time, these cell changes can lead to cervical cancer if they are not treated.38 "typically, the length of time from infection with hpv to development of cervical cancer is about 15-20 years. for this reason, although most hpv infections occur in tee­ nagers and young adults, cervical cancer is more common in women in their 40s and 50s."39 in addition to cervical cancer, hpv can also cause cancers of the anus, vagina, vulva, penis, head, and neck.4° finally, mothers can transmit the hpv virus to their baby when it passes through the birth canal during deliv­ ery.4' cervical cancer claims 270,000 lives annually worldwide, making it the second leading cause of cancer deaths in women.42 papanicolaou ("pap") tests have helped cut cervical cancer rates in the united states, but the american cancer society reported that in 2006, over 9700 american women were diag­ nosed with cervical cancer and 3700 american women died from this cancer.43 it is projected that cervical cancer will kill more than 4600 women in the unit­ ed states in 2007.44 hpv cannot be cured; however, there are treatments for the health related issues that occur as a result ofhpv infection.45 "regular pap tests and follow­ up treatment can prevent most, but not all, cases of cervical cancer;" however, no hpv tests are currently available for men, and diagnosis is therefore prob­ lematic if no warts are present. 46 "pap tests can detect cell changes in the cervix before they turn into cancer," but the tests cannot detect all types of cervical cancers while they are still in curable phase.47 however, "[m]ost women diag­ nosed with cervical cancer in the u.s. have either never had a pap test, or have 36. !d. 37. !d. see also stark, supra note 34, at cl. 38. cdc, hpv answers, supra note 12. 39. the children's hosp. of philadelphia, vaccine educ. ctr., a look at each vaccine: human p apillomavirus vaccine, http://www.chop.edu/consumer/jsp/division/ ge­ neric.jsp?id=84544 [hereinafter children's hospital, a look at hpv] (last visited mar. 20, 2008). 40. cdc, hpv answers, supra note 12. see also paulson, supra note 25, at bl. 41. children's hospital, alookathpv, supra note 39. 42. major breakthrough, supra note 13, at a8. 43. cdc, hpv answers, supra note 12. "the pap test is performed by scraping off cells from the opening of the cervix and examining them under the microscope to see whether they have begun to show changes consistent with the early development of cancer (called pre­ cancerous changes)." children's hospital, a look at hpv, supra note 39. 44. sandra scantling, vaccinating against hpv makes sense, even for young girls, hartford courant, july 15,2007, at h4. it should be noted that one-half of all the cases of cervical cancer occur in low-income and minority women. see, e.g., editorial, fighting cancer in school, l.a. times, aug. 18, 2006, at blo [hereinafter fighting cancer}. 45. cdc, hpv answers, supra note 12 (health problems caused by hpv include geni­ tal warts, cervical cell changes, and cancers of the cervix, vulva, vagina, and anus). 46. !d. 47. !d. 2008] mandating the gardasil vaccine 409 not had a pap test in the last 5 years:48 thus, the pap test, though an imperfect tool, is nonetheless an essential weapon in the fight to save women from cervi­ cal cancer. abstinence is the only sure way to prevent hpv. 49 those individuals who are sexually active can reduce their risk by being in a monogamous relationship with someone who has had no other sex partners or by limiting their number of sex partners. 50 even someone with only one lifetime sex partner can still con­ tract hpv if his or her partner has had previous partners? in 2002, the cdc conducted a study on sexual activity and contraceptive use among teenagers, which revealed that forty-six percent of never-married males and females be­ tween the ages of fifteen and nineteen have had sexual intercourse at least once. 52 moreover, a quarter of the teenagers who engaged in sexual intercourse did not use any method of contraception. 53 based on these statistics, it is evi­ dent that parents and the government cannot rely on children remaining absti­ nent until marriage. the gardasil vaccine, administered at an early enough age, can at least dramatically reduce the possibility of females contracting hpv and cervical cancer. b. gardasil on june 8, 2006, the fda approved the nation's first hpv vaccine, gar­ dash. "gardasil protects against hpv types 16 and 18, which cause approxi­ mately 70 percent of cervical cancers and types 6 and 11, which cause approximately 90 percent of genital warts. "54 this vaccine, which is produced by merck & co., inc. could dramatically reduce the incidence of cervical cancer and genital warts in vaccinated women; however, women should still have reg­ ular pap tests to detect the types ofhpv that gardasil does not prevent. 55 gardasil will only work for women who have not yet been exposed to cer­ tain types ofhpv.56 currently, there is no test available to tell if a woman has been exposed to the four hpv types against which gardasil protects. 57 since the vaccine is only effective for women who have not been previously exposed to hpv, the fda has licensed the vaccine's use for girls and women ages nine to twenty-six. 58 also, "[t]he u.s. centers for disease control and prevention's 48. jd. 49. id. 50. jd. 51. cdc, hpv answers, supra note 12. 52. ctr's for disease control & prevention, u.s. dep't of health & human services, vital & health statistics, ser. 23, no. 24, at 5 (2004), available at http:// www.cdc.gov/nchs/data/series!sr_ 23/sr23 _ 024.pdf (last visited mar. 20, 2008). 53. jd. at 9. 54. killackey, supra note 11, at aio. 55. id. 56. /d. 57. cdc, hpv answers, supra note 12. 58. major breakthrough, supra note 13, at a8. 410 indiana health law review [vol. 5:403 advisory committee on immunization practices voted unanimously to recom­ mend that girls and women 11 to 26 years old be vaccinated with gardasil and that 9-year-old and 1 0-year-old girls can be vaccinated with gardasil at the dis­ cretion of their physicians. "59 moreover, some doctors have expressed the opinion that some older women should also be vaccinated.60 the gardasil vaccine does not provide protection against all types ofhpv and will not, therefore, impede the development of all types of cervical cancer and genital warts.61 "about 30% of cervical cancers will not be prevented by the vaccine, so it will be important for women to continue getting screened for cervical cancer [through] (regular pap tests)."62 furthermore, gardasil does not inhibit hpv types responsible for about ten percent of genital warts and will not prevent other sexually transmitted infections. 63 the hpv vaccine is administered in a series of three shots, over a six­ month period, and costs around $360 exclusive of the doctor's fee for adminis­ tering the inoculation.64 most insurance companies cover the vaccine for fe­ males under the age oftwenty-seven.65 in november of2006, the cdc added gardasil to its list of vaccines provided by the federal vaccines for children program. 66 through the vaccines for children program, children who are eigh­ teen or younger who are eligible for medicaid, have no health insurance or are underinsured, or are native american or native alaskan, will be eligible to receive the vaccine for free. 67 some states also seek to facilitate the vaccination process for the uninsured or underinsured by providing free or low cost vacci­ nations at public clinics.68 59. ladley, supra note 16, at 10. 60. mathis, supra note 28, at 114. 61. cdc, hpv answers, supra note 12. 62. jd. 63. jd. 64. jd. the first dose is administered on a date chosen by the female recipient. the sec­ ond dose is given two months after the first dose, while the third dose is given six months after the first dose. all three doses are required to receive the vaccine's full benefits. gardasil pamphlet, supra note i 0. 65. mathis, supra note 28, at 114. 66. lynn doan, schools to offer std vaccine, l.a. times, july 24, 2006, at b3. 67. ctr's for disease control & prevention, u.s. dep'i of health & human services, vaccines & lmmljnizations: vfc: for parents (2006), http://www.cdc.gov/ nip/vfc/parent!parent_home.htm (last visited mar. 20, 2008). the vaccines for children pro­ gram (the "program") was created by congress after the outbreak of a measles epidemic in the united states in the late 1980s, an epidemic which resulted in tens of thousands of cases of mea­ sles and hundreds of deaths. the program was funded through the omnibus budget reconcilia­ tion act of 1993. the program is administered at the national level by the cdc through the national immunization program. currently, vaccines that prevent the following diseases are covered by the program: diphtheria, haemophilus influenzae type b, hepatitis a, hepatitis b, influenza, measles, meningococcal disease, mumps, pertussis, pneumococcal disease, polio, rotavirus, rubella, tetanus, and varicella. !d. 68. cdc, hpv answers, supra note 12. 2008] mandating the gardasil vaccine 411 when a new vaccine becomes available, there is no sure way to estimate the likely duration of its effectiveness.69 with regard to the gardasil vaccine, however, research indicates that women are still protected five years after in­ noculation. 70 however, it may be necessary for vaccinated women to receive a booster shot of the vaccine at a later date. 71 it has still not been determined if gardasil is effective in males. 72 it is possible that the vaccination of males would be beneficial in that it might pre­ vent or reduce the incidence of both genital warts and rare types of cancer. 73 moreover, vaccinating males might indirectly improve the health of the female population by reducing hpv transmission rates. 74 accordingly, studies are now being conducted to determine whether the gardasil vaccine will "prevent hpv infection and diseases in males."75 if positive information results from the stud­ ies now underway, gardasil could be "licensed and recommended" for males as well as females. 76 merck's gardasil was the first hpv vaccine approved for use by the fda in the united states, but other companies are currently working on similar vac­ cines. 77 glaxosmithkline and medimmune, inc. are currently developing cer­ varix, an alternative to gardasil, which could be approved in the united states this year.78 cervarix may offer broader cervical cancer protection than gar­ dash; however, it will not prevent genital warts. 79 in an effort to find a cheaper alternative to gardasil and cervarix, two researchers in kentucky are cultivat­ ing proteins from tobacco plants that could be used to prevent cervical cancer as well. 80 although the tobacco-based vaccine is still in the early stages of devel­ opment, the researchers estimate that the vaccine would only cost three dollars for three doses. 81 thus far, the tobacco-based vaccine has been effective when administered to dogs, and researchers believe the first phase of human clinical trials could start as early as next year. 82 clearly, hpv vaccines can save lives and reduce the spread of at least some hpv types. indeed, given the health benefits and life saving potential of hpv vaccines, like gardasil, cerarix, and the tobacco-based version currently in development, states should follow the precedent set in their previous vacci69. id. 70. jd. 71. jd. 72. jd. 73. cdc, hpv answers, supra note 12. 74. id. 75. jd. 76. id. 77. stark, supra note 34, at cl. 78. jd. 79. mathis, supra note 28, at 114. 80. associated press, tobacco-based drug studied; hope for cervical cancer vaccine, kentijcky posr, july 31, 2007, at ai 0. 81. !d. 82. id. 412 indiana health law review [vol. 5:403 nation campaigns against diseases such as polio, measles, mumps, rubella, and hepatitis band make hpv vaccination mandatory. ill. it is constitutional for states to mandate the gardasil vaccine a. cases establishing states' authority to mandate vaccination federal law does not require the vaccination of children or adolescents.83 under the public health service act, however, the secretary of health and human services has the authority to make and enforce regulations necessary "to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the states or possessions, or from one state or pos­ session into any other state orpossession."84 although the act's language ap­ pears to grant broad authority to "prevent the spread of diseases," it neither authorizes the promulgation of federal regulations related to mandatory vacci­ nation programs generally, nor suggests the implementation of mandatory vac­ cination programs, necessary to prevent or eliminate public health emergencies. 85 indeed, the preservation of public health has historically been the responsibility of state and local governments, and the authority to enact laws relevant to the protection of public health is therefore derived from the states' general police powers.86 the following cases uphold that tradition. in gibbons v. ogden, chief justice john marshall held that the state's po­ lice powers "form a portion of that immense mass oflegislation, which embraces every thing within the territory of a state, not surrendered from the general gov­ ernment .... [and] [i]nspection laws, quarantine laws, [and] health laws of every description ... are component parts of this mass."87 this doctrine was emphasized by justice miller in the slaughter-house cases88 where he held that a state statute intended to protect the public health was clearly an example of the state's police power.89 based on this presumption, miller concluded that if police power was the key to social order, then the preservation ofhealth stood at the core of that power.90 no american court, however, contemplated the in83. cdc, hpv answers, supra note 12. 84. the public health service general powers and duties quarantine and inspection: regulations to control communicable diseases, 42 u.s.c. § 264 (2002). 85. angie a. welborn, mandatory vaccinations: precedent and current laws, in crs rep. for cong. 2005, at crs-5 (cong. res. serv., libr. ofcong., ord. code rs2 1414, 2005). 86. id. see also people v. robertson, 134 n.e. 815,817 (1922)("thatthe preservation of the public health is one of the duties devolving upon the state as a sovereign power will not be questioned."). 87. gibbons v. ogden, 22 u.s. 1, 203 (1824). 88. see generally slaughter-house cases, 83 u.s. 36 (1873). 89. wendy e. parmet, from slaughter-house to lochner: the rise and fall of the con­ stitutionalization ofpublic health, 40 am. j. legal hist. 4 76, 482 (1996). 90. ld. at 483. 2008) mandating the gardasil vaccine 413 terplay between police power and state sanctioned vaccination until the court in hazen v. strong considered citizens' objections to vaccination. in hazen, the court upheld the power of a local town council to pay for the vaccination of persons exposed to smallpox even though there were no actual cases of small­ pox in the community.91 laws mandating immunization first appeared in the early nineteenth cen­ tury, and the first was promulgated in the commonwealth ofmassachusetts.92 in 1827, boston was the first city to require the vaccination of public school students.93 the policy was later enacted throughout all ofmassachusetts.94 in an effort to maximize vaccination rates, other states also began implementing mandatory vaccination policies for children attending public school.95 during this time period, "[flew fourteenth amendment cases decided by the supreme court actually dealt with state actions designed to protect the public against traditional epidemic diseases."96 two cases that addressed the issue of state mandated vaccination policies during that time period were campagnie fra­ caise de navigation a vapeur v. louisiana state board of health, which upheld a louisiana board of health ban against immigrants at the time in which infectious diseases were prevalent,97 and jacobson v. massachusetts, which upheld a massachusetts ordinance requiring a mandatory smallpox regu­ lation.98 jacobson v. massachusetts is the seminal united states supreme court decision affirming the power of the state to compel vaccination. 99 in jacobson, a massachusetts statute gave local boards of public health the power to require vaccination for the residents of their respective towns. 100 on february 27, 1902, the board ofhealth of cambridge required all residents of the city to be vaccinated for smallpox. 101 jacobson refused to be vaccinated, claiming that the statute abridged his privileges as a citizen, deprived him ofliberty without due process oflaw, and was thereby a violation of his fourteenth amendment rights. 102 the supreme court ruled that it is within the police power of a state 91. hazen v. strong, 2 vt. 427 (1830). 92. hodge, jr. & gostin, supra note i, at 851. president thomas jefferson was the first to recognize the public health value of vaccinations. he was occasionally called the "greatest patron of vaccination in america," inoculating hundreds of his own family members and friends. id. at 842-43. 93. !d. at 851. 94. !d. 95. jd. 96. parmet, supra note 89, at 493. 97. see generally compagne francaise de navigation a vapeaur v. la. state bd. of health, 186 u.s. 380 (1902). 98. see generally jacobson v. mass. 197 u.s. 11 (1905). see also parmet,supranote 89, at 493-94. 99. i d. many states had, however, already required citizens to submit to mandatory vaccinations for a variety of diseases, including smallpox. 100. jd. at 12-13. 101. !d. 102. !d. at 13-14. 414 indiana health law review [vol. 5:403 to enact a compulsory vaccination law, and it is for the legislature, not the courts, to determine whether vaccination is, or is not, the best mode for the pre­ vention of smallpox and the protection of the public health.' 03 the court found that when the board of health adopted the regulation, smallpox was prevalent and the disease was spreading. 104 because state police powers include regula­ tions created to protect the public health, and the public health was threatened by smallpox, both the massachusetts statute and the regulation governing the boards of health were deemed valid by the court. 105 the court acknowledged the possibility that vaccines might not be an ef­ fective means to prevent and control the spread of smallpox; however, it deter­ mined that the legislature has the right to pass laws that, according to the common belief of the people, are adapted to prevent the spread of contagious diseases. 106 in a free country, where the government is by the people, through their chosen representatives, practical legislation admits of no other standard of action, for what the peo­ ple believe is for the common welfare must be accepted as tending to promote the common welfare, whether it does in fact or not. 107 the court could not and did not decide that vaccination would prevent smallpox; however, it took judicial notice ofthe fact that it was the common belief of the people of the state that it would. 108 based on this rationale, the court held that the statute in question was a public health law enacted through a reasonable and proper exercise of the state's police power. 109 furthermore, the court concluded that a minority of citizens could not defy the decisions of their legislature, when the legislature acted "in good faith for all" if the minority's actions would endanger the welfare of the entire community. 110 although the court ruled that the mandatory vaccination statute fell with­ in the state police powers of massachusetts, the court did prescribe limits to such power. specifically, the court set forth a reasonableness test for manda­ tory vaccination statutes that examined the reasonableness of the relationship between the state's vaccination policy and its obligation to protect the public health.'" in jacobson, the vaccination program was deemed reasonable be­ cause smallpox was prevalent in cambridge, and the board of health's only 103. /d. at 12. 104. /d. at 27. 105. jacobson, 197 u.s. at28. 106. /d. at 35. 107. /d. 108. /d. 109. /d. 110. jacobson, 197 u.s. at 37-38. 111. !d. at 31. 2008] mandating the gardasil v accjne 415 motivation in enacting the mandatory policy was to protect the public from that threat. 112 the supreme court also held that courts may strike down legislation de­ signed to protect the public welfare only when it "has no real or substantial re­ lation to [public health, morals, or safety] or is, beyond all question, a plain, palpable invasion of rights secured by the fundamental law .... " 113 ironically, the court found that state police powers have limits that can be encroached upon by the judiciary when the police powers are used in an "arbitrary and op­ pressive" manner. 114 however, this limitation notwithstanding, the jacobson decision firmly established as a matter of constitutional law that states may util­ ize their police powers to compel reasonable vaccination in the interest of pub­ lic health. subsequently, however, courts have concluded that state mandated vacci­ nations do not constitute a violation of either the right to constitutional due process or equal protection.115 for example, adams v. milwaukee held that vaccination regulations treating cows held outside the city differently than those held inside the city did not violate the fourteenth amendment, because they had a "proper relation to the purpose to be accomplished." 116 seubo/d v. fort smith special school district held that school vaccination requirements did not deprive individuals ofliberty and property interests without due process of the law. 117 brown v. stone held that allowing religious exemption to vaccination violates the equal protection clause because it discriminates against those chil­ dren whose parents are not religiously motivated. 118 b. application of jacobson today the significant medical, social, and economic benefits provided by vacci­ nations have led all fifty states to promulgate laws mandating that children be vaccinated before they enter school. despite all of the positive benefits vacci­ nations confer, however, an anti-vaccination sentiment is spreading throughout the united states due to misinformation, philosophical and religious beliefs, and a general desire to be free from government coercion. as such, the law faces a difficult challenge in determining how to balance public health welfare against a parent's individual right and freedom to raise his or her child as he or ll2. !d. 113. jd.at3!. 114. !d. at 38. 115. steve p. calandrillo, comment, vanishing vaccinations: why are so many ameri­ cans opting out of vaccinating their children?, 37 u. mich. j.l. reform 353, 358 (2004) ("subsequent cases have confirmed that compulsory vaccination laws do not violate one's con­ stitutional right to due process or equal protection, or interfere with the practice of religion under the first amendment."). 116. adams v. city ofmilwaukee, 228 u.s. 572, 581-82 (1913). 117. seubold v. fort smith special sch. dist., 237 s.w.2d 884, 887 (ark. 1951 ). 118. brown, et al. v. stone, et al, 378 so. 2d 218, 223 (miss. 1979). 416 indiana health law review [vol. 5:403 she sees fit, especially now that gardasil has been approved for use and has the potential to save thousands of american lives annually. the supreme court in jacobson v. massachusetts ruled that it is within the police power of a state to enact a compulsory vaccination law. 119 it went on to note that it is for the legislature and not for the courts to determine whether a vaccination is or is not in the best interest of the public health. 120 to aid the court in the interpretation of legislative intent, the court established a reason­ ableness test for mandatory vaccination statutes. 121 the vaccination statute must be reasonable in light of the prevalence of the disease, and the state must not have any motivation other than the protection of the public's health. 122 jacobson was decided in 1905, when smallpox was still a global threat. "smallpox killed an estimated 300 million people worldwide in the twentieth century .... " 123 at the time jacobson was decided, smallpox was a prevalent and increasing threat in communities throughout the nation. obviously, there­ fore, the statute to require smallpox vaccination had a substantial relation to the public's health, and thus, was not considered arbitrary or oppressive. the vac­ cination was to be administered to everyone and for free if an individual could not afford it. the state was looking out for the good of the people by mandat­ ing the vaccination. moreover, because of the smallpox vaccine, "the world health organization embarked on a twelve year inoculation blitz," and by 1979, it declared smallpox eradicated.124 the smallpox disease was the first disease to be eliminated from the face of the earth. 125 now, states must decide whether or not to add gardasil to the list of vaccinations that females must receive prior to school entry. in determining the constitutionality of mandating the gardasil vaccina­ tion, it is necessary to examine issues of substantive due process. substantive due process guarantees that laws will be reasonable and not arbitrary. 126 for the court to determine whether or not a state can mandate gardasil, it must employ a rational basis or minimal scrutiny test. the rational basis standard is used whenever the strict scrutiny or intermediate scrutiny tests are not applicable. 127 since mandating a vaccination does not deal with a suspect class, an implied fundamental right, or a classification based on gender or legitimacy, strict and intermediate scrutiny do not apply. 128 under the rational basis standard, a law 119. jacobson, 197 u.s. at 11-12. 120. /d. 121. /d.at3l. 122. /d. 123. westhead, supra note 1, at fl. 124. /d. 125. see, e.g., id. 126. black's law dictionary 223 (2nd pocket ed. 2001). 127. 16b am. jur. 2d constitutional law §812 (2007). 128. to date, gardasil has only been proven effective for females. cdc, hpv answers, supra note 12. ifthe on-going studies prove that gardasil is as safe and effective in males, this note would encourage mandatory vaccination for both men and women. until then, this note can only encourage compulsory vaccination for females. 2008] mandating the gardasil vaccine 417 will be upheld if it is rationally related to a legitimate interest. 129 since it is dif­ ficult to fail this test, most governmental action examined under this standard is upheld unless it is arbitrary or irrational. 130 moreover, under the rational basis analysis, laws are presumed valid, leaving the challenger with the burden of proof. 131 given the amount of deference the court gives to the legislature's decision, this is a difficult test to meet. in using the court's rational basis test to determine if it is constitutional to mandate gardasil vaccination for females entering school, the law is presumed valid. the burden of proof is placed on the challenger (a parent or guardian opposed to the vaccination) to persuade the court that the law is arbitrary or irrational. prior to the fda's approval ofgardasil, challengers to the vaccina­ tion began citing several reasons why they would oppose it as a mandatory vac­ cination. critics of the vaccination question its effectiveness, oppose the number of vaccines students currently receive, believe that a vaccine should not be mandatory for a disease that could be prevented by behavior modification, fear the vaccine will promote sexual activity, and inhibit a parent's right to make choices for his or her child. despite these claims, gardasil should be mandated for children entering school based on the following arguments. 1. an "all or nothing" approach is not the best approach to take when thousands of lives may be saved by the vaccine in the united states critics of the gardasil vaccine question its effectiveness. gardasil's big­ gest claim is that it has been found to be "1 00 percent effective. " 132 it is impor­ tant to note that gardasil is 100% effective against four of the many hpv strains. 133 moreover, gardasil protects against two strains (hpv types sixteen and eighteen) that lead to seventy percent of all cervical cancers, 134 "[b]ut 70 percent is not the same as eradication.''135 that still leaves thirty percent of cer­ vical cancer cases untouched. as such, even if every woman in the nation were vaccinated, effective hpv treatment and prevention would still require annual pap tests. 136 barbara loe fisher, president and co-founder of the national vaccine in­ formation center, has voiced doubt as to the propriety of mandatory hpv vac­ cination in the united states, since "most [american] women receive regular annual pap tests. " 137 pap tests usually catch hpv "before it develops into can129. black's law dictionary 582-83 (2nd pocket ed. 2001). 130. 16b am. jur. 2d constitutional law § 813 (2007). 131. id. 132. sprigg, supra note 18, at al7. 133. id. 134. id. 135. id. 136. id. 137. simons, supra note 17. 418 indiana health law review [vol. 5:403 cer."138 moreover, because of pap test public awareness campaigns, "the in­ stance of cervical cancer fell74 percent between 1955 and 1992."139 although pap tests have "slashed the rates of most cervical cancers in this country, [they] didn't do the same for a cancer called cervical adenocarcinoma."14° cervical adenocarcinoma can be missed by a pap test because it occurs high up in the cervix. 141 critics claim that gardasil should not be mandated because it is not 100% effective against all strains that lead to cervical cancer; however, this note con­ tends that, even if 100% prevention is not possible, mandated vaccination is still the most reasonable approach to take. using an all or nothing approach to decide whether or not to mandate the vaccine is illogical because such an ap­ proach fails to consider that gardasil is 100% effective against two of the main stt:ains ofhpv that lead to cervical cancer (hpv types sixteen and eighteen). although gardasil does not have complete effectiveness against all types of hpv, it can still save thousands oflives each year. it seems logical to suggest however, that savings thousands oflives a year is far better than not saving any lives at all. 2. since safety concerns and myths have been addressed, the number of vaccines children currently receive should not detract from the fact that gardasil could save thousands of lives another common complaint raised by those who oppose mandatory gar­ dasil vaccination is that children are already required by state laws to receive a large number of vaccinations. according to fisher: in the 1980s, u.s. children got 23 doses of seven vac­ cines by age six. today, they get 48 doses for 14 vac­ cines in the same period. 'and during the time that vaccines doses have doubled,' she says, 'there's been an increase in the number of children with autism, attention deficit and hyperactive disorder, learning disabilities, asthma, and diabetes, in which vaccines could be a con­ tributing factor.' 142 professor neal a. halsey of the johns hopkins university institute for vaccine safety suggests that many of these claims have no merit. 143 professor halsey stated, 138. jd. 139. jd. 140. marissa conrad, the cancer a pap could miss, glamour, dec. 2006, at i42. 141. jd. i42. simons, supra note i7. see also hodge, jr. & gostin, supra note i, at 887. 143. hodge, jr. & gostin, supra note i, at 887. 2008] mandating the gardasil vaccine the increasing incidence of diabetes, autism, and other medical conditions for which no specific etiology has been identified parallels the increase in many other fac­ tors such as the use of wireless communications, com­ puters, and fast food restaurants. one could easily hypothesize that these factors or many other changes in our lifestyles contributed to the increases in these dis­ eases, but there is no scientific evidence to support these ideas. 144 419 despite critics' concerns, emory's vaccine center states that all recommended vaccines are extraordinarily safe. 145 side effects are typically limited to a low grade fever or pain and tenderness in the area where the shot was given. 146 gardasil's known side effects include pain, itching, fever, nausea, dizzi­ ness, and redness at the injection site. 147 additionally, positive "post-licensure safety data" for the first eleven months of the united states' experience with gardasil was recently released. 148 during a june 2007 meeting of the cdc's advisory committee on immunization practices, dr. john iskander presented data that confirmed serious adverse events associated with gardasil are rare. 149 dr. iskander noted that "the serious adverse event reporting rate is [only] 1.8 per 100,000 doses."15° for those injured due to immunizations, congress passed the national vaccine injury compensation program in 1986, which provides a no-fault compensation plan with damages for pain and suffering capped at $250,000. 151 gardasil has been covered under this program since february 1, 2007, and no claims involving the gardasil vaccine have been filed as of june 7, 2007. 152 moreover, the fda is currently considering whether to approve pentacel, "a five-in-one vaccine that could reduce the number of jabs children receive. "153 pentacel is designed to replace the shots for polio, diphtheria, tetanus, pertus­ sis, and hib. 154 thus, the number of vaccinations that children are required to 144. !d. 145. vaccines 101: vaccine myths, emoryvaccrnecel'iter, 2004, http://www.vaccines .emory.edu/vaccines/myths/shtml (last visited mar. 20, 2008). 146. !d. 147. gardas!lpamphlet, supra note 10. 148. heidi splete, largest study to date supports gardasil 's safety in first year of use, pediatric news, july i, 2007, at 15, 15. as oftheendofmarch 2007, more than five million doses of gardasil have been distributed in the united states. !d. 149. !d. 150. /d. 151. the public health service, national vaccine injury compensation program: com­ pensation, 42 u.s.c. § 300aa-15 (1997). 152. splete, supra note 148, at 15. 153. fda advisers back 5-in-1 childhood vaccine: if approved, concoction could elim­ inate 7 of the jabs kids receive, associated press, jan. 25, 2007, available at http:// www.msnbc.msn.com/id/168l3053/wid/11915773?gtl=8921 (last visited mar. 20, 2008). 154. !d. (stating that the vaccine first appeared in canada in 1997 and is now available in 420 indiana health law review [vol. 5:403 receive will likely be reduced in the near future. consequently, because vacci­ nations have been proven safe and gardasil's side effects are mild, the gardasil vaccine should be given to girls prior to entering school. 3. regardless of the fact that hpv could be reduced through behavior modification, gardasil should be viewed in the same light as the vaccine for hepatitis b other critics of gardasil feel that a compulsory vaccination is not neces­ sary for a disease such as hpv that is not transmitted through casual contact.155 "since the bringing together oflarge numbers of children clearly facilitated the spread of smallpox, and since vaccination provided a relatively safe preventive, it was natural that compulsory school attendance laws should lead to a move­ ment for compulsory vaccination. " 156 however, that is not the case when deal­ ing with the transmission of hpv. cervical cancer and genital warts are not contagious diseases in the same manner as mumps, measles, and chicken pox, which can be spread in classrooms.157 the strains ofhpv that cause cervical cancer and genital warts are transmitted "through sexual contact," which are activities children are not (or should not be) engaging in at school.158 although, with the recent discovery of hpv under young men's fingernails, scientists have admitted they have more to learn about how hpv is really transmitted. the concern for how the disease is transmitted did not prevent states from including hepatitis b on the list of required immunizations for adolescents at­ tending school. 159 every state except montana requires that children entering either day care or school be immunized against hepatitis b. 160 moreover, the cdc recommends all infants receive the hepatitis b vaccine even though hepa­ titis b is an adult disease that is not highly contagious, deadly (for most that contract it), or present at epidemic levels in the united states (except among high-risk groups). 161 although the virus for hepatitis b can be found in saliva, it is not com­ monly transmitted by casual contact. 162 hepatitis b is primarily transmitted "through infected body fluids."163 however, hepatitis b, is not a deadly disease for most people. 164 eight other countries). 155. sprigg, supra note 18, at a17. 156. hodge, jr. & gostin, supra note l, at 850 (quoting john duffy, school vaccination: the precursor to school medical inspection, 33 j. hist. med. 344, 345 (1978)). 157. major breakthrough, supra note 13, at a8. 158. sprigg, supra note 18, at al7. 159. gian aliprendi, immunization requirements by state, sabin vaccine lnst., mar. 20, 2007, available at http://www.sabin.org/files/pdf/irnmunization _schedule_ 2007 .pdf. 160. !d. 161. nat'l vaccine info. ctr., hepatitis b vaccine: the untold story, http:// www.nvic.org/diseases/hepbnlr.htm (last visited mar. 20, 2008). 162. !d. 163. !d. 164. !d. 2008] mandating the gardasil vaccine [i]n cases of acute hepatitis b 'most patients do notre­ quire hospital care' and '95 percent of patients have a favorable course and recover completely' with the case­ fatality ratio being 'very low (approximately 0.1 per­ cent).' those who recover completely from hepatitis b infection acquire life-long immunity. of those who do not recover completely, fewer than 5 percent become chronic carri­ ers of the virus with just one quarter of these in danger of developing life threatening liver disease later in life .. 165 421 despite these statistics, every state but montana requires immunization for he­ patitis b prior to entering school. 166 according to staci geller, head of illinois' cervical cancer elimination task force: '[it] needs to be explained that in many ways [gardasil] is a vaccine like other vaccines that we give to healthy children. you want to protect against cervical cancer and not get caught up in the mode of transmission .... ' 'if we told people you get hpv by coughing, they'd be in the doctor's office in a minute. but nobody wants to think about their daughter having sex.' 167 since hepatitis b and hpv are both transmitted through non-casual contact, and cervical cancer results in more harm as it kills nearly 4000 american women annually, the gardasil vaccine should be mandated throughout the country just like the hepatitis b vaccine. 165. !d. 166. aliprendi, supra note 159. many question whether mandatory hepatitis b vaccina­ tions are paving the way for forced vaccination with the acquired immune deficiency syn­ drome ("aids") vaccine. hepatitis b is not transmitted by casual contact like smallpox or polio; rather, it is transmitted by high risk behavior such as intravenous drug use and sexual promiscuity. as such, it is the first high risk transmission disease for which mandatory vaccina­ tion has been required for all children. with identical transmission routes as hiv, there are strong indications that forced vaccination of infants and children with hepatitis b is just a trial run for forced vaccination with an aids vaccine when it eventually reaches the market. illinois state representative mary flowers is sponsoring a bill that would require hiv tests during each of the three school physicals currently required by state law. see laura camper, bill proposes hivtestsfor students, the state journal-register, jan. 21,2007, at a13. 167. judy peres & bruce japsen, states craft hpv vaccine bills, clllcago tribune, feb. 11, 2007, at c3. 422 indiana health law review [vol. 5:403 4. mandating gardasil will not encourage children to engage in sexual activity the hottest debate with regard to mandating gardasil primarily centers on conservative organizations such as the family research council and focus on the family, which oppose anything they believe promotes or condones premari­ tal sex. 168 micah clark, director of the american family association oflndi­ ana, believes that mandating gardasil will say to girls: "hey, you can engage in sexual activity and not be at risk for this disease .... "169 however, no research exists that suggests giving a young girl a vaccine against an std would en­ courage her to become sexually active. 170 "seat belts do not cause reckless driving, tetanus shots do not cause children to seek out rusty nails ... support and approval ofhpv vaccination is not synonymous with support and approval of promiscuity. rather, it is a cry to rally together to eradicate cervical cancer worldwide."171 moreover, the university of north carolina at chapel hill school of public health conducted a study that effectively negates micah clark's belief that mandating gardasil would give young women a false sense of security. the study found that girls who were vaccinated with gardasil were not likely to engage in sex more often than those who were not. 172 noel t. brewer, assistant professor ofhealth behavior and health education at the university of north carolina at chapel hill and author of the study, said, "one of the main arguments against vaccinating young women for hpv is that they will some­ how compensate for the vaccine's protective nature by having more sex .... our findings say otherwise."173 additionally, the vaccine will not leave girls with a message that they are invincible against hpv or cervical cancer because most girls will not even know what vaccine they are receiving at the doctor's office. indeed, the majority of girls receive multiple required shots for school and few ask questions. however, if a girl does inquire about what vaccination she is receiving, the doctor should inform the girl what the vaccine prevents and stress that it is not 100% effective in preventing the disease. indiana senator connie lawson said, "parents and pediatricians need to explain that it's a vac­ cine against cancer .... it's not about promiscuity. ifl am a female and ire168. simons, supra note 17. 169. staci hupp, senators: vaccinate girls against cancer virus, the indianapolis star, jan. 18, 2007, at a8 [hereinafter hupp, senators: vaccinate] (quotation in original). 170. fighting cancer, supra note 44, at bio. 171. carolyn susman, hpv vaccine may also be given to boys, sun herald, aug. 3, 2006, at bl (quotation in original). 172. press release, the university ofnorth carolina-chapel hill, human papillornavirus vaccine does not lead adolescent girls to have more sex, most parents agree (july 5, 2007) (on file with the author). 173. id. (quotation in original). 2008) mandating the gardasil vaccine 423 main abstinent until i get married, there's no guarantee that the man that i marry will not have hpv."174 5. mandating gardasil is in the child's best interest pro-family groups firmly believe that parents alone "should decide what is best for their children." 175 those groups believe that "just because something is good for you the government should [not] force you to do it .... "176 as such, an argument could be made that parents have a substantive due process right to privacy and family autonomy with regard to child rearing, which would require a strict scrutiny analysis when deciding whether to mandate gardasil. how­ ever, most courts do not generally follow strict scrutiny review in such in­ stances citing that a parent's right to make decisions and control his or her child is not without limitations, especially with regard to the education and the health of a child. 177 "[t]he supreme court has yet to decide whether the right to di­ rect the upbringing and education of one's children is among those fundamental rights whose infringement merits heightened scrutiny."178 yet, the first and tenth circuit courts of appeal have held that "the parental right to direct the upbringing and education of children ... does not include a right to exempt one's child from public school requirements" such as mandatory immuniza­ tions.179 thus, the government should mandate gardasil vaccinations to prevent many parents from opting out of the vaccine due to inaccurate information on the safety of vaccines, or due to fears that it will promote sexual activity, which studies disprove. parents, in their efforts to protect their child from one of these harms, would actually hurt their child by denying her access to this life-saving 174. hupp, senators: vaccinate, supra note 169, at a8 (quotation in original). 175. sprigg, supra note 18, at al7. 176. id. 177. see fields v. palmdale sch. dist., 427 f.3d 1197, 1208-ll (9th cir. 2005), opinion amended on denial of rehearing, 447 f.3d 1187 (9th cir. 2006) (the parents of elementary school students brought an action against the school district when they learned that the school conducted surveys with their children about sexual topics, to better understand the psychologi­ cal barriers to learning. the parents claimed a violation of their right to privacy and right to control the upbringing of their children. the u.s. court of appeals held that parents have no fundamental right to control the upbringing of their children by introducing them to matters of sex in accordance with their personal and religious beliefs. the 9th circuit used a rational basis test claiming that the survey did not violate a fundamental right); leebaert v. harrington, 332 f.3d 134, 135-39 (2d cir. 2003) (the parents of a student brought an action against the school board of education claiming it had violated their son's rights by refusing to excuse him from a mandatory health education course and subsequently tailing him. the court of appeals held the parents' claim was subject to a rational basis review, rather than strict scrutiny because there is no fundamental right that includes the right to tell public schools what to teach or not to teach.); brown v. hot, sexy & safer productions, inc., 68 f.3d 525, 533 (lst cir. 1995)(holding that a parental challenge to a public school's aids awareness and sex education program was not rooted in a constitutionally protected right). 178. brown, 68 f.3d at 533. 179. leebaert, 332 f.3dat 140. 424 indiana health law review [vol. 5:403 vaccination. the state would be looking out for the children's health by man­ dating gardasil, which meets the required rational basis review. 6. states should mandate gardasil to ensure that the vaccine's cost is covered so that the highest number off emales have access to the vaccine whether or not a state "recommends" or "requires" a vaccine is becoming an important distinction in some states when considering the cost of the vac­ cine. recently, the state of indiana announced a plan to charge many parents for vaccines that are recommended but not required. 180 in support of this con­ tention, indiana officials cite the fact that the availability of government fund­ ing for vaccines has not kept pace with the costs of vaccine administration. 181 under indiana's proposed plan, vaccines for diphtheria, tetanus, acellular per­ tussis, measles, mumps, rubella, polio, hepatitis b, and chicken pox will remain free; however, the vaccines for influenza, hepatitis a, meningitis, rotavirus, tetanus diphtheria, and tetanus diphtheria acellular petussis will be subject to fees. 182 iflndiana merely recommends the gardasil vaccine, fewer females will receive the vaccine because its costs will not be covered under the new plan unless they have insurance or can qualify for the vaccine under the vaccines for children program. therefore, in order to ensure that all females have access to gardasil, states should mandate the vaccination. 7. vaccination programs save money in the long-run large scale vaccination programs have been proven to save money over­ all, and "mass vaccinations in america have yielded tremendous financial sav­ ings."183 various methods such as benefit-risk, benefit-cost, and cost­ effectiveness analysis have been used to determine that vaccine-preventable diseases cost sixteen times more in medical-related costs than do the vaccines that prevent those diseases. 184 that statistic is staggering as "american adults contracting vaccine-preventable diseases still result in $10 billion worth of un­ necessary health care costs and more than 30,000 otherwise avoidable u.s. deaths each year. "185 gardasil costs a total of$360 for the three necessary shots in addition to the doctor's administration fee, which many might consider very 180. see generally staci hupp, under vaccine plan, parents pay; health q[ficials worry kids won't get certain shots, the indianapolis star, jan. 14,2007, at bl. 181. !d. federal payments to the state for vaccines total about $1 0 million annually; how­ ever, costs to administer the shots are estimated at $19 million a year. this lag in funding can be attributed to the fact that the number of vaccines have more than doubled in the past two decades. according to the cdc, "[i]n 1985, it cost about $45 to fully vaccinate a child." in 2006, it cost approximately $837 to fully vaccinate a child. !d. 182. !d. 183. calandrillo, supra note 115, at 379. 184. !d. at 379-80. 185. !d. 2008] mandating the gardasil vaccine 425 expensive.186 however, a number of major health insurance companies have already agreed to cover the cost of the hpv vaccination in their policies.187 as such, "[i]nsurance plans covering 60 percent of americans who receive health­ care benefits already pay for at least part of gardasil 's [$360] cost .... "1 88 fur­ thermore, in 2006, the cdc voted to add gardasil to its list of vaccines pro­ vided by the federal vaccines for children program. 189 this means that medicaid-eligible, uninsured or underinsured, and native american girls ages nine to eighteen can now receive gardasil vaccinations free of charge. 190 8. mandatory vaccination programs ensure universal coverage thereby creating the most effective way to prevent diseases such as hpv and cer­ vical cancer the courts have traditionally aligned themselves with the views of state legislators, school board officials, and public health experts who supported the need for vaccination to preserve communal well-being. "[m]andatory vaccina­ tion programs for public school students help to assure nearly universal cover­ age."191 dr. walter orenstein, director ofthe national immunization program, stated "school laws establish a system for immunization, a system that works year in and year out, regardless of political interest, media coverage, changing budget situations, and the absence of vaccine-preventable disease outbreaks to spur interest. " 192 in 1963, twenty states throughout the country required immu­ nization against certain diseases for school entrance.193 by 1970, the number of states requiring immunization increased to twenty-nine. 194 a study published in 1969 demonstrated that states with actively-enforced laws covering the total school population correlated with lower rates of measles. 195 the 1969 study attracted the attention of many states, and by 1980, all fifty states had enacted school immunization laws. 196 186. cdc, hpv answers, supra note 12. 187. sabine vollmer, few pediatricians have first cancer vaccine, the news & 0bserver(releigh, n.c.), oct. 7, 2006 (on file with the author). 188. jd. 189. doan, supra note 66, at b3. 190. ctr's for disease control & prevention u.s. dep't of health & human services, vfc: for parents (2006), http:/ /www.cdc.gov/nip/vfc/parent/parent_ home.htm (last visited mar. 20, 2008). 191. zoltan, supra note 2, at 736. 192. daniel a. salmon, mandatory immunization laws and the role of medical, reli­ gious, and philosophical exemptions 1 (oct. 2003) (unpublished commentary, on file with the author). 193. id. 194. /d. 195. /d. 196. /d. 426 indiana health law review [vol. 5:403 requirements that students receive a vaccine prior to enrollment in school "have proven effective in preventing infectious diseases and help to decrease racial and ethnic disparities in vaccine utilization."197 moreover, vaccines have dramatically reduced morbidity and mor­ tality rates of some of the worst diseases in history by preventing them on the front end. the benefits have been remarkable: millions of deaths have been pre­ vented, millions more lives markedly improved, and bil­ lions of dollars of societal resources have been saved for use in countless other valuable endeavors. 198 today, vaccines protect against over twenty deadly diseases including small­ pox, measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, hepatitis a and b, some forms of influenza, pneumoccocal disease, hib, and varicella. 199 9. many states have begun measures to mandate gardasil over forty states and the district of columbia have introduced legislation that would allocate funding to educate the public about gardasil, with at least twenty states specifically seeking to mandate the vaccine for female students. 200 since january of2007, at least twenty-four states, as well as the district of co­ lumbia, have introduced legislation that would specifically mandate the garda­ sil vaccination for girls entering public school.201 states have, however, faced challenges to the passage of statutes intended to make gardasil vaccination mandatory. for example, in michigan and ohio, legislators attempted to pass legislation mandating use of the vaccine, but failed. 202 in february of 2007, texas almost became the first state to mandate gardasil for girls attending public school.203 texas governor, rick perry, issued an executive order to bypass the legislature to ensure the mandate would be in effect by the fall of 2008?04 governor perry's executive order would have allowed parents to opt out of the 197. simons, supra note 17. 198. calandrillo, supra note 115, at 369. 199. /d. at 369-81 200. clarence page, wise, but unnecessary hpv laws, chicagotrib., feb. 11,2007, at c7. see also nat'l conf. of state legislatures, hpv vaccine, www.ncsl.org/ pro­ grams/health/hpvvaccine.htm#hpvlegis (last visited mar. 20, 2008). 201. nat'l conf. of state legislatures, supra note 200. the following states at­ tempted to mandate gardasil vaccination in 2007: california, colorado, florida, georgia, illi­ nois, kansas, kentucky, maryland, massachusetts, michigan, minnesota, mississippi, missouri, new jersey, new mexico, new york, ohio, oklahoma, south carolina, texas, vermont, vir­ ginia, and west virginia. /d. 202. /d. 203. required std shots worry some parents, associated press, feb. 5, 2007, http:// www.msnbc.msn.com/id/l6975112/wid/119l5773?gt1=9033 (also on file with the author). 204. /d. 2008] mandating the gardasil vaccine 427 vaccination due to either religious or philosophical reasons; however, state leg­ islators passed a bill in april of2007 blocking governor perry's executive or­ der?05 because governor perry said that he would not veto the bill, virginia has now officially become the first state to mandate the gardasil vaccine.206 under the virgina statute, sixth-grade girls must be vaccinated with gar­ dasil beginning in 2009 unless parents choose to opt their daughters out ofthe program?07 moreover, as a result of the virginia mandate, planned parenthood of southeastern virginia has added gardasil to the services available at its clin­ ics. 208 the city council of the district of columbia has also passed a bill man­ dating gardasil for females before the age of thirteen; however, it is awaiting congressional approval. 209 many states have also enacted legislation that will provide the vaccine to females at little or no cost. then ew hampshire health department has agreed to provide gardasil at no cost to females under the age of eighteen.210 in less than one year, the new hampshire health department has distributed over 14,000 doses.211 south dakota has announced a plan similar to new hamp­ shire's. the south dakota department of health now offers gardasil to young women between the ages of eleven and eighteen, free of charge.212 in less than one year, the south dakota department of health has dispensed over 20,000 doses of the vaccine. 213 when claims are reviewed under the rational basis analysis, it would be constitutional for states to mandate the gardasil vaccination for girls entering the sixth grade. although the vaccine will not completely prevent all cases of cervical cancer and genital warts, it will drastically reduce the 3 700 deaths that result in the united states annually from cervical cancer.214 the fact that hpv is not transmitted through casual contact like many of the diseases that have warranted mandatory vaccination is not reason enough to continue allowing thousands of women to die when there is a vaccine that could substantially re­ duce the mortality rate. by requiring the vaccine for hpv, the government is not condoning or encouraging females to engage in sexually promiscuous activ­ ity. in actuality, the government is merely recommending that the vaccine be administered to females at an age when they are impressionable and will dis­ cuss the vaccine with their doctor and parents. females will hopefully realize 205. ld. see also heather burcham, cervical cancer victim fought for hpv vaccine; urged legislators in texas to save young girls' lives, chicago sun times, july 26, 2007, at 57. 206. !d. see also elizabeth simpson, planned parenthood offering hpv vaccines, virginia pilot & ledger-star, july i 0, 2007, at al2. 207. simpson, supra note 206, at al2. 208. burcham, supra note 205, at 57. 209. national conference of state legislatures, supra note 200. 210. !d. 211. !d. 212. see !d. 213. !d. 214. major breakthrough, supra note 13, a8. 428 indiana health law review [vol. 5:403 the dangers that can result from sexual promiscuity and be more cautious if they eventually decide to engage in sexual behavior. moreover, if states require every eleven year-old girl to receive the gardasil vaccine prior to entering school, the mandate can not be considered arbitrary. the states are taking steps for the greater good of the community: to protect the health of every female against cervical cancer, a life-threatening illness that thousands of americans lose their lives to each year. iv. it is constitutional for the state to deny parents' religious and philosophical exemptions to the gardasil vaccine a. cases discussing exemptions to vaccinations rather than having each state's health department require immunization during an emergency, state legislatures have adopted mandatory immunization requirements for children entering school or day care facilities to prevent the spread of diseases.215 all fifty states, the district of columbia, and puerto rico have implemented mandatory vaccination laws that cover children "from kin­ dergarten through 12th grade" in public and private schools, as well as children enrolling in day care. 216 although "the cdc publishes a schedule of immuni­ zations based on the recommendations of the advisory committee on immuni­ zation practices, the american academy ofpediatrics' committee on infectious diseases, and the american academy of family physicians," each state inde­ pendently determines the vaccinations required for school entry in that state, as well as if it will permit medical, philosophical, or religious exemptions for the vaccinations?17 1. medical exemptions all fifty states allow medical exemptions to vaccinations. 218 children who are immuno-comprornised, suffer from cancer, or who are allergic to the vaccines typically qualify for a medical exemption. 219 proof of medical exemp­ tion must take the form of a signed statement by a medical doctor stating that the administration of one or more vaccines would be detrimental to the health of the child. 220 the power of clinicians to circumvent mandatory vaccination 215. hodge, jr. & gostin, supra note 1, at 868. 216. alan r. hinman et al., tools to prevent infectious disease: childhood immunization: laws that work, 30 j.l. meo. & ennes 122, 124 (2002). 217. hodge, jr. & gostin, supra note 1, at 868. 218. hinman et al., supra note 216, at 124. 219. !d. 220. nat'l vaccine info. ctr, legal exemphons to vaccinahon (2006), http://www. nvic.org/state-sitellegal-exemptions.htm [hereinafter na nonal vaccine lnforma non center, legal exemptions) (last visited mar. 20, 2008). 2008] mandating the gardasil vaccine 429 requirements is not, however, unlimited. for example, most states do not allow chiropractic doctors to write medical exemptions to vaccination.221 2. philosophical exemptions philosophical exemptions refer to other non-religious beliefs held by the parents who do not believe that their child should be immunized. twenty states allow exemptions to vaccination based on philosophical, personal, or conscien­ tiously-held beliefs.222 in order to employ the philosophical or personal belief exemption in many of these states, "individuals must object to all vaccinations, not just one particular vaccine."223 however, federal health officials and medi­ cal organizations are urging state legislators to revoke this type of exemption to vaccinations because many parents are merely using it as a convenient way to avoid the necessity of conforming to the state's vaccination mandates and rec­ ommended immunization schedule. 224 3. religious exemptions the religious exemption is granted based on the first amendment to the constitution, which grants the right to freely exercise one's religion. because citizens are protected under the first amendment, it has been said that a state must have a "compelling state interest" before this right can be taken away.225 in jacobson v. massachusetts, discouraging the spread of communicable dis­ eases was proven to be a compelling state interest.226 however, the court in prince v. massachusetts held that the freedom to act according to one's own religious beliefs is subject to reasonable regulation when society's welfare is threatened. 227 today, forty-eight states provide for religious exemptions to vaccination requirements, with mississippi and west virginia as the only states that do not.228 the national vaccine information center states that: 221. !d. the religious exemption is intended for people who hold a sincere religious belief opposing vaccination to the ex222. nat'l networkforimmunizationlnfo., lmmljnizationpoucy: exemptions from immunization laws (2005), http://www.immunizationinfo.org/immunization _policy_ detail. cfv?id=44 (noting that the following twenty states have philosophical exemptions: arizona, arkansas, california, colorado, idaho, louisiana, maine, michigan, minnesota, missouri, ne­ braska, new mexico, north dakota, ohio, oklahoma, texas, utah, vermont, washington, and wisconsin) (last visited mar. 20, 2008). 223. national vaccine information center, legal exemptions, supra note 220. 224. !d. 225. see sherbert v. verner, 374 u.s. 398,403 (1963). 226. jacobson, 197 u.s. at 11, 11 (1905). 227. princev. mass., 321 u.s. 158, 166-68 (1905). 228. calandrillo, supra note 115, at 413 (citation omitted). 430 indiana health law review tent that if the state forced vaccination, it would be an infringement on their right to exercise their religious be­ liefs. some state laws define religious exemptions broad­ ly to include personal religious beliefs, similar to personal philosophical beliefs. other states require an individual who claims a religious exemption to be a member ofthe first church of christ, scientist (chris­ tian science) or another bonafide religion whose written tenets include prohibition of invasive medical proce­ dures such as vaccination. (this kind of language has been ruled unconstitutional when it has been challenged in state supreme courts.) some laws require a signed af­ fidavit from the pastor or spiritual advisor of the parent exercising religious exemption that affirms the parents' sincere religious belief about vaccination, while others 11 h . "d. 229 a ow t e parent to sign a notanze waiver. [vol 5:403 although forty-eight states currently permit a religious exemption to vaccina­ tion based on the first amendment, states may prohibit or regulate conduct in general.230 this is true even if the prohibition or regulation happens to interfere with a person's religious practices.231 the free exercise clause cannot be used to challenge a law of general applicability unless it can be shown that the law was motivated by a desire to interfere with religion?32 despite the fact that many states offer the religious exemption, "the u.s. supreme court has never ruled on the constitutionality of religious exemptions from vaccination requirements."233 pertinent case law suggests that "mandatory immunization against dangerous diseases does not violate the first amendment right to free exercise of religion," as long as there is no conflict between the two.234 in employment division v. smith, the court stated, "[ w ]e have never held that an individual's religious beliefs excuse him from compliance with an oth­ erwise valid law prohibiting conduct that the state is free to regulate. "235 in the 1990s, the court retreated from its strict scrutiny standard and held that, as long 229. national vaccine infor.m:ation center, legal exemptions, supra note 220. 230. !d. 231. !d. 232. emp. div. v. smith, 494 u.s. 872 (1990). in smith, a prohibition against the use of peyote was challenged by a person whose religious beliefs require use of peyote during religious ceremony. despite the challenger's religious beliefs, the court was not required to provide a religious exemption for him. !d. the supreme court held that no religious exemption was re­ quired because ofthe religiously-neutral nature, even though people objected because the regu­ lation interfered with conduct inspired by sincerely held religious beliefs. jd. 233. salmon, supra note 192, at 2. 234. !d. 235. smith, 494 u.s. at 895. 2008] mandating the gardasil vaccine 431 as the law is religion-neutral and generally applicable, it does not interfere with the right to free exercise of religion.z36 the court did note two exceptions to this rule of minimum scrutiny. one exception to the rule of minimum scrutiny is when there is a violation ofboth the free exercise clause and a second con­ stitutional right such as freedom of speech or a parent's right to direct the edu­ cation of his or her child.237 this exception is known as the hybrid-rights exception. in prince v. massachusetts, the court held that the first amendment's free exercise clause does not allow for the right to expose the community or one's children to harm from disease.z38 the court held: the right to practice religion freely does not include lib­ erty to expose the community or the child to communi­ cable disease or the latter to ill health or death . . . . parents may be free to become martyrs themselves. but it does not follow they are free, in identical circum­ stances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves.239 the court in wright v. dewitt school district followed that rationale when it ruled that a compulsory vaccination law with no religious exemption is consti­ tutional because the right to free exercise of religion is subject to reasonable regulation for the good of the community. 240 several state courts have applied this reasoning in ruling that mandatory vaccination of school children does not interfere with the right to religious freedom. in cude v. arkansas, the arkansas supreme court noted, "in cases too numerous to mention, it has been held, in effect, that a person's right to exhibit religious freedom ceases where it overlaps and transgresses the rights of others."241 b. it is constitutional for the state to deny parents non-medical exemptions to the gardasil vaccine the late nineteenth century was the last period in american history when societal integrity was routinely threatened by "ravaging epidemics of infectious disease. "242 as such, many individuals today have never witnessed the debili236. ld. at 886. 237. !d. at 881. 238. prince, 321 u.s. at 166-70. 239. /d. 240. wright v. dewitt sch. dist., 385 s.w.2d 644, 648 (ark. 1965). 241. cude v. arkansas, 377 s.w.2d 816, 817 (ark. 1964). 242. parmet, supra note 89, at 477. 432 indiana health law review [vol. 5:403 tating diseases that vaccines protect against, a situation which has allowed an attitude of complacency toward immunization requirements to build. dr. ed­ ward p. rothstein, a pennsylvania pediatrician who helps the american acad­ emy of pediatrics make immunization recommendations, recalled: i remember how the fear of polio changed our lives -­ not going to the swimming pool in the summer, not go­ ing to the movies, not getting involved with crowds .... i remember pictures of wards full of iron lungs, hun­ dreds in a room, with kids who couldn't breathe in them. it affected daily life more than aids does today."243 clearly, americans are no longer accustomed to the terrors, both real and imag­ ined of incurable epidemic diseases. in addition to not witnessing the effects of the life-threatening diseases, the anti-vaccination sentiment is quickly growing in the united states due to the disputed link between immunizations and autism, which is in large part due to sensational media stories.244 as such, increasing numbers of parents are re­ fusing immunizations for their children and seeking legally-sanctioned exemp­ tions instead?45 state legislatures and health departments now face a difficult challenge in that they must design and implement legislation and policies that both respect individual rights and freedoms while at the same time safeguarding the public welfare.246 exemptions from mandatory vaccinations pose a serious threat to the pub­ lic health. studies show that unvaccinated children may be twenty-two times more likely to suffer from measles than their vaccinated peers. 247 by causing a decline in the overall immunization levels in the united states, "unvaccinated children increase the risk of disease exposure and transmission" in a commu­ nity.248 since high immunization levels indirectly protect the community as a whole through "herd immunity," a decline in vaccinated children can lead to disease resurgence.249 not only do exemptions threaten public health, but they also cause some parents to opt out of the vaccinations merely as a convenience. according to dr. walter a. orenstein, director of the national immunization program at the cdc, "[a]cross the country about 1 percent of all children are exempt from 243. donald g. mcneil, jr., when parents say no to child vaccinations, n.y. times, nov. 30, 2002, at a2. 244. calandrillo, supra note 115, at 421. 245. !d. 246. id. at 429. 247. daniel r. feiken et al., individual and community risks of measles and pertussis associated with personal exemptions to immunization, 284 jama 3145, 3149 (2000). 248. linda e. lefever, note, religious exemptions from school immunization: a sincere belief or a legal loophole?, 110 penn sr. l. rev. 1047, 1048 (2006). 249. /d. 2008] mandating the gardasil v acclne 433 vaccinations .... "250 a survey conducted by orenstein's agency suggests "that more than 90 percent of all american children have had most shots, ex­ cept for the new chicken-pox vaccine."251 a study in the american journal of public health found that, [h]ow many children receive the exemptions depends partly on how much red tape is involved . . . . in states where parents must go to a state office for exemption forms, get their signatures notarized or produce letters from a religious authority, exemption rates tend to be lower.252 moreover, in all but a handful of jurisdictions, requests for exemptions are nei­ ther seriously documented nor verified. 253 often, the law requires a parent to do no more than simply check a box indicating that he or she does not want to have his or her child receive a vaccination.254 this technique is employed in states such as washington, california, and colorado.255 as such, places like vashon island, washington, have allowed eighteen percent of the primary school students' parents to legally opt out of vaccination against childhood dis­ eases.256 the u.s. supreme court has never ruled on the constitutionality of relig­ iously justified vaccination exemptions.257 however, similar case law in­ dicates that mandatory immunization without religious exemptions does not violate a person's right to free exercise of religion. the court in employment division v. smith held that the free exercise clause, assuming that it is not coupled with another constitutional right, cannot be used to challenge a law of general applicability unless it can be shown that the law was motivated by a desire to interfere with religion. 258 as such, if a law is religion-neutral and gen­ erally applicable, it does not interfere with one's right to free exercise ofrelig­ ion.zs9 an argument could be made that if a state mandates gardasil, it impli­ cates the hybrid-rights exception from the smith case. a parent opposed to her 250. mcneil, jr., supra note 243, at a2. 251. id. 252. id. {quotation in original). 253. calandrillo, supra note 115, at 360. 254. i d. if checking a box is not sufficient and documentation is required, one is welcome to join the congregation ofuniversal wisdom., whose tenets hold unnatural compositions (i.e., vaccines) shall not be injected into the body. the congregation has over 5000 members to date, and it primarily consists of parents seeking exemptions to vaccination requirements. i d. 255. mcneil, jr., supra note 243, at a2. 256. id. 257. salmon, supra note 192, at 2. 258. emp. div., dep't of human res. of or. v. smith, 494 u.s. 872 (1990). 259. ld. 434 indiana health law review [vol. 5:403 child receiving the vaccine for religious reasons could argue that the state's mandate implicates the hybrid-rights exception because both the free exercise clause and her right to direct the education ofher child are being violated. un­ der the hybrid-rights exception, the court in smith held that strict scrutiny should be applied in this situation. however, this exception should not apply since courts have not applied this exception uniformly.260 several courts have interpreted the "hybrid-rights" exception as mere dicta and not applied strict scrutiny analysis. 261 in leebaert v. harrington, the court refused to apply strict scrutiny analysis when the plaintiff claimed that compelling his child to attend health classes violated both his free exercise rights and his constitutional right to direct the upbringing of his child. the court refused to apply strict scrutiny analysis for the following reasons: 1) the court in smith did not decide the case upon the hybrid-rights theory, 2) [the first, ninth, tenth, and d.c. circuits, which] claim the hybrid-rights theory war­ rants strict scrutiny have yet to apply strict scrutiny; and 3) adjudication of rights under the free exercise clause should not change because other constitutional rights are involved. 262 as such, mandating the gardasil vaccination for all females in school is a relig­ ion-neutral law and generally applicable. indeed, no religious motivations accompany the states' requirement that all children receive the gardasil vaccination. the health and safety of the community as a whole is the sole motivation for requiring the vaccination. therefore, although clusters of parents may be opposed to state mandated gar­ dasil vaccinations, due to religious beliefs regarding the administration of shots in general or because they believe it will promote premarital sexual activity, those beliefs should not be a factor in the states' decision to require those fe­ males not subject to non-medical exemptions to be vaccinated with gardasil. moreover, the states' mandated vaccination is generally applicable even though the shot is only available to females. currently, the shot is only available for females, but the manufacturer is conducting experiments to determine whether or not the vaccine is safe for males. if the vaccination is proven effective for males, states should require that everyone, females and males, be vaccinated with gardasil. if states mandate the gardasil vaccination but allow for non-medical ex­ emptions, it poses a threat to public safety, which defeats the vaccination's pur­ pose. clusters of unvaccinated children are not only a potential danger to 260. jack peterson, note, exceptions to employment division v. smith: a need for change, lolewis&clarkl.rev. 701, 710(2006). 261. id. 262. id. at 713. 2008] mandating the gardasil vaccine 435 themselves, but they are also a threat to the "herd immunity" that walls out epi­ demics.263 "[t]he rise in exemptions also imposes substantial financial burden on the health care system in dealing with the outbreaks that do occur."264 clear­ ly, the state should strive to maintain a zero tolerance policy for societal risks resulting from exemptions. indeed, the elimination of all exemptions to com­ pulsory vaccinations, would be the most effective means of preventing many possible cases of cervical cancer and/or genital warts. thus, in order to provide the greatest benefit for the greatest number of individuals, only medical exemp­ tions should be allowed by the various states. v. conclusion relevant case law indicates that it is constitutional for states to mandate the gardasil vaccine for all females entering the sixth grade. even though booster shots may be required and annual pap tests should still be conducted, the vaccination is a benefit to the society as a whole. the fact that hpv is not transmitted through casual contact is not reason enough to continue allowing thousands of women to die annually, as a result of cervical cancers resulting from hpv infection, when gardasil has the potential to save their lives. more­ over, requiring the administration of the vaccine does not encourage females to engage in sexually promiscuous activity. no studies can substantiate that claim. instead, females can take the opportunity to discuss the vaccine with their parents and doctor to realize the dangers of sexual promiscuity. addition­ ally, by requiring every eleven year-old girl to receive the vaccine, the mandate is not arbitrary. indeed, states are looking out for their citizens' best interests by requiring the vaccination because gardasil could potentially save 3 700 u.s. women annually from death caused by cervical cancer. in the past, states have permitted parents to claim non-medical exemptions to mandated vaccinations. however, such exemptions should not be allowed for the gardasil vaccination. indeed, there is no constitutional basis for exemp­ tions to vaccinations. also, states should strive to maintain the most effective vaccination program possible. evidence shows that by allowing check-box opt out provisions for religious or philosophical reasons, universal coverage is not achieved. historically, states have not actively verified all of the philosophical and religious exemptions for prior vaccines, which in tum make the opt-out provisions merely a convenience exemption for parents. since this opt out pro­ vision is a convenience for parents, evidence reflects that these provisions have been abused. moreover, the right to practice religion freely does not include the liberty to expose the community or a child to disease. therefore, based on the overriding interest in the community's health and safety, non-medical ex­ emptions to the gardasil vaccine should not be allowed. 263. mcneil, jr., supra note 243, at a2. 264. calandrillo, supra note 115, at 361. closing the deal: making the right congressional decision about patent settlement agreements amyc. waltz* table of contents i. lntroduction ..................................................................................... 156 ii. relevant law: incentives to settle patent infringement suits by agreement .......................................... 157 a. patent law: conflicting interests give rise to incentives to settle .................................................................... 158 b. the sherman antitrustact: protecting competition ................. 160 c. the complete process: from anda to settlement.. ................. 161 d. today's pharmaceutical market: market incentives to settle patent infringement suits ........................................... 162 ill. the history of the debate ........................................................... 164 a. schering-plough: patent settlement agreements with upsher and esi ........................................................................ 165 b. zeneca: patent settlement agreement with barr ....................... 166 c. bayer: patent settlement agreement with barr ........................ 167 iv. the details of the debate ............................................................ 168 a. the arguments for settlement: the courts and the industry .................................................................................... 168 1. the courts' reasoning: consistently upholding settlement agreements ....................................................... 168 2. the pharmaceutical industry: protecting investments through settlement ............................................................ 170 3. the view of the generic manufacturers: a good business decision .............................................................. 172 b. the arguments against patent settlement agreements: the ftc and the consumer ..................................................... 173 1. the ftc: protecting the consumer .................................... 173 2. consumer groups and other interested parties ................. 175 v. making the call: the best option for congress ...................... 176 a. the call for congressional action ............................................ 176 b. congress' options: codification, legislation, and limitation .......................................................................... 177 * j.d. candidate, 2008, indiana university school of law-indianapolis; b.a., 2005, franklin college oflndiana. 156 indiana health law review [vol. 5:155 c. the right choice: codification, with limits ............................. 179 vi. conclusion ....................................................................................... 182 i. introduction in an era of rapidly rising health care costs, america's legislators are con­ tinually searching for ways to decrease costs to the consumer, while america's health care suppliers and providers strive to increase profits and improve the bottom line. recently, these two competing interests have come head to head in one ofhealth care's largest economic arenas, the pharmaceutical market. to date, the skirmishes have taken place in courts, but the biggest battle is still to come, on the floors of the united states congress. one current battle has centered on patent settlement agreements made be­ tween brand name pharmaceutical manufacturers (often referred to collectively as big pharma) and generic manufacturers. recently brought to the forefront of health care law by major pharmaceutical companies such as schering-plough ("schering") and bristol-myers squibb, these settlements have been the subject of many recent court cases and congressional hearings. the agreements are aimed at avoiding patent litigation and often include provisions which prevent the generic version of the pioneer drug from entering the market for a certain period of time. the federal trade commission ("ftc") claims that these agreements are resulting in unsubstantiated higher pharmaceutical costs, and that they may have anticompetitive effects on the market after the supreme court's recent denial of certiorari in two major patent settlement agreement cases, 1 the ftc has turned to congress for relief, seeking legislation that would prohibit or, in the very least, limit these settlements. congress began holding hearings on the issue in the summer of 2006 and has continued to hear testimony on the issue as recently as january, 2007. the question in the minds of all involved is simple: should congress address the issue of the validity of patent settlement agreements, or is this an issue for the courts to decide? first, this note discusses the arguments on both sides of the issue and will analyze the options available to congress in light of the supreme court's re­ fusal to hear the cases. initially, the discussion identifies relevant patent and antitrust law, the current state of the pharmaceutical industry, and the effect each has on incentives for pharmaceutical companies to settle patent infringe­ ment suits. second, this note addresses the history of the debate, chronicling the three major court cases involving these agreements. third, this note details the arguments being made by the major players involved. these players in­ clude the pharmaceutical industry, the courts, the ftc, and consumer groups which have weighed in on the topic. forth and finally, the discussion analyzes 1. schering-plough corp. v. ftc, 126 s.ct. 2929 {u.s. june 16, 2006); joblovev. barr labs., 127 s. ct. 3001 (u.s. june 25, 2007). 2008] closing the deal: patent seitlement agreements 157 the various options available to congress and suggests that congress should codify the courts' position while incorporating provisions to address the ftc's concern with anticompetitive effects. ll. relevant law: incentives to seitle patent infringement suits by agreement in the pharmaceutical industry, patent infringement suits are common and can be time-consuming and costly for both parties. generic manufacturers have very little to lose from challenging pioneer patents in an attempt to gain a find­ ing of invalidity. winning a patent infringement suit against a blockbuster drug can earn a generic company millions of dollars in profits. 2 on the other hand, pioneer patent holders have everything to lose. indeed, if the pioneer patent holder's patent is found to be invalid, a brand name pharmaceutical manufac­ turer is unlikely recoup the profits lost in the years of research and development it has devoted to development of the drug. as such, pioneer patent holders have huge incentives to fight patent infringement suits with every available re­ source. recently, many pharmaceutical companies, both brand name and generic, have found settlement of such suits to be extremely advantageous. patent and antitrust laws, while designed to promote competition, serve conflicting inter­ ests which can give rise to incentives to settle. issues within the pharmaceutical industry may provide additional incentives. for example, litigation costs for both sides are slashed when settlements are made early in the process, and in many situations, generic companies gain licenses to market drugs which would not otherwise be available to them and vice versa. these incentives have made settlement of patent infringement suits increasingly popular. most settlements include payments to the generic manufacturer in return for a delay in the market entry of the generic drug. these payments are often referred to as brand payments3 or reverse payments by the courts because, as the second circuit describes, the valid patent holder has the right to exclude the infringer from the market but "nonetheless pays that party not to do so. ,.4 in 2. blockbuster drugs are generally defined as drugs with more than one billion dollars per year in sales. marcia angell, the trum about me drug companies: how they deceive us and what to do about it i 0 (random house trade paperbacks 2005). some industry members, however, use $500 million as the threshold for classifying blockbuster drugs. see generally generic pharmaceuticals: marketplace access and consumer issues: hearing before the s. comm. on commerce, science, and transportation, 107th cong. 13 {2002) (statement of kathleen d. jaeger, president & ceo, generic pharm. ass'n), available at http://frwebgate.access.gpo.gov/cgi-binlgetdoc.cgi?dbname=l 07 _senate_ hearings&docid=f9 ol55.pdf. 3. john fazzio, pharmaceutical patent settlements: fault lines at the intersection of intellectual property and antitrost law require a return to the rule of reason, 11 j. tech. l. & pol'y 1, 14 (2006). 4. joblove v. barr labs, inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187, 205 (2d cir. 2006), cert. denied, 127 s. ct. 3001 (2007) (while the official name of the case 158 indiana heal1h law review [vol. 5:155 some cases, called supply agreements, the brand name manufacturer may also receive licenses to market similar or other drugs made by the ~eneric manufac­ turer under the name of the brand name. s for example, in a much-litigated set­ tlement·· between pharmaceutical manufacturer schering and generic manufacturer upsher-smith laboratories ("upsher''), schering received several licenses to market upsher products. 6 the opposite may also be true. under license agreements, the generic company may receive non-exclusionary licenses to market generic versions of the pioneer drug before or after expiration of the pioneer patent. 7 the ftc, fearing that these patent settlement agreements are causing phannaceutical costs to rise, has repeatedly challenged the settlements, implor­ ing courts to find that such settlements violate antitrust law. despite conflicting standards of review for cases challenging patent settlement agreements, 8 how­ ever, courts have generally found settlement agreements to be valid as long as (1) the infringement claim is "neither a sham nor otherwise baseless,"9 and (2) the settlement does not "[restrain] competition beyond the scope of the ... [p ]atent. "10 ' · a. patent law: conflicting interests give rise to incentives to settle patent protection has been a tenet of american law since the writing of the constitution. the framers themselves envisioned patent protection for innova­ tion, establishing a specific right of congress "[t]o promote the progress of sci­ ence and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries; ... "11 today's pat­ ent laws generally allow twenty years of patent protection for phannaceutical discoveries.12 the effective life of such patents is, however, often much short­ er. companies routinely file patent applications early in the drug development process to better protect their research investment as it moves through the drug approval process. by the time the drug is approved by the food and drug ad­ ministration ("fda") and reaches the market, half of the patentterm may have expired. is job love, the case will be referred to as tamoxifen for clarity purposes throughout the text of this note. references to the actual drug at issue will be lower-case (''tamoxifen")). 5. fazzio, supra note 3, at 13. 6. schering-plough corp. v. ftc, 402 f.3d 1056, 1059-60 (lith cir. 2005), cert. de­ nied, 126 s.ct. 2929 (u.s. june 16, 2006); see also discussion infra part ll.a. 7. fazzio, supra note 3, at 13. 8. for further discussion on the relevant standard of review, see fazzio, supra note 3, at 38 (suggesting that the supreme court should adopt a "nlle of reason" analysis). 9. joblove, 466 f.3d at 208. 10. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 540 (e.d.n.y. 2005). 11. u.s. const. art i. § 8, cl. 8. 12. 35 u.s.c.a. § 154(ax2) (west 2007). 2008] closing me deal: patent settlement agreements 159 pharmaceutical patent challenges by generic competitors are regulated by the hatch-waxman amendments ("amendments").13 the amendments pro­ pose to "balance two conflicting policy objectives: to induce name-brand phar­ maceutical firms to make the investtnents necessary to research and develop new drug products, while simultaneously enabling competitors to bring cheap­ er, generic copies of those drugs to market."14 in attempting to balance these conflicting interests, the amendments create a complex system in which ge­ neric manufacturers may produce and market copies of pioneer drugs in certain situations. often, the conflicting interests served by the amendments provide incentives for pioneer patent holders and generic manufacturers to settle patent infringement suits. once a pioneer drug has been patented and approved by the fda, the amendments allow generic manufacturers to file an abbreviated new drug application ("and a''). the anda must state that the drug is ''bioequivalenf' to the pioneer drug and certify that generic marketing of the drug will not in­ fringe on the pioneer patent fqr one of four reasons: first, the anda applica­ tion may certify that the pioneer patent has not been filed. second, the anda application may certify that the pioneer patent is expired. third, the anda application may certify that the pioneer patent will expire on a certain date. fourth, the anda application may certify that the pioneer patent is invalid or not infringed upon by the proposed generic.15 this last certification is the most common and the most relevant to the subject of patent agreements. under this certification, commonly known as a paragraph iv certification, ''the anda [filer] must give notice to the pioneer patent holder ... [after which the] patent holder has forty-five days within which to file suit against the generic manufac­ turer. filing the .suit triggers an automatic 30-month stay during which the fda cannot approve the generic manufacturer's anda."16 in essence, the thirty-month stay gives the pioneer manufacturer an extra two and one-half years of exclusivity on the market, precluding any issues of infringement damages since the generic drug cannot be marketed until the end of the thirty-month period. the thirty-month stay also provides time for the patent litigation to commence and conclude.17 if the generic company wins, and the court finds the patent to be invalid or not infringed, the generic is able to enter the market immediately following the thirty-month period. if the brand name manufacturer wins and the patent is held to be valid, however, the generic is precluded from marketing its own version of the drug until expiration of the pioneer patent. 13. drug price competition and patent restoration (hatch-waxman) act of 1984,98 stat. 1585 (1984) (codified as amended at 21 u.s.c.a. § 355 (west 2007)). 14. m. elaine johnston & matthew j. galvin, antitrust aspects of settling intellectual property litigation, 867 pliipat 159, 162 (2006) (quoting h.r. rep. no. 98-957 at 14). 15. !d. 16. ld. at 162-63. see the same article for more detailed information regarding the anda process. 17. angell, supra note 2, at 180. 160 indiana healrn law review [vol. 5:155 as additional incentive for generic manufacturers to file and as, the first company to file such an application without infringing upon the pioneer patent receives a 180-day period of exclusive marketing rights. 18 while the 180-day exclusivity period effectively excludes other generic manufactures from market­ ing their own generic versions of the pioneer drug once the pioneer patent has been eliminated, it also creates the opportunity for a bottleneck.19 if the first anda filer fails to market its generic drug and fails to trigger the exclusivity period, all other generic manufacturers are precluded from entering the market as well. 20 therefore, "if the brand name manufacturer can reach a settlement agreement, convincing the first anda filer not to enter the market, he prevents all generic entry.'.21 thus, the exclusivity period provided by the amendments gives brand name manufacturers some incentive to settle patent infringement claims with generic manufacturers, effectively prolonging the bottleneck effect. the medicare prescription drug, improvement, and modernization act of 2003 ("medicare act") modified the amendments, clarifying much-litigated issues.22 first, the medicare act allows two generic applicants to share the 180-day exclusivity period, in the event that both manufacturers file anda applications on the same day. 23 second, in order to reduce the bottleneck effect created by the 180-day exclusivity period, the medicare act states that the ex­ clusivity period is forfeited if the generic filer does not meet certain time re­ strictions for marketing its generic version of the pioneer drug.24 thus, the medicare act reduces the incentives to settle patent infringement claims pro­ vided by the amendments by allowing other generic manufactures to gain sub­ sequent exclusivity periods if the original generic filer does not market its version of the drug. additionally, the medicare act may impose a chilling effect on this activity by requiring all patent settlements be reported to the ftc. 25 thus, one effect of entering into a patent settlement agreement is to trigger ftc notice and review. b. the sherman antitrust act: protecting competition the sherman antitrust act ("sherman act'') prohibits"[ e ]very contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade 18. johnston & galvin, supra note 14, at 163. 19. fazzio, supra note 3, at 12. 20. /d. 21. /d. 22. medicare prescription drug, improvement, and modernization (medicare act) act of2003, tit. xi, i 17 stat. 2066 (2003) {codified as amended in scattered sections of21 u.s.c.a. § 355 (west 2007)). 23. fazzio, supra note 3, at 17. 24. medicare act, tit. xi§ 1102 (codified as amended at 21 u.s.c.a § 355(j)(5)(d)(ii)). 25. /d. 2008] closing the deal: patent setilement agreements 161 or commerce .... "26 the act's primary purpose "is to protect interbrand com­ petition .... [which] takes place when manufacturers of the same product com­ pete for the business of consumers, creating lower prices.'m settlement agreements between brand name pharmaceutical companies and generic manu­ facturers are an example of interbrand competition and fall under the sherman act.28 opponents of patent settlement agreements argue that the settlements violate the purpose of the sherman act by discouraging interbrand competition and keeping pharmaceutical costs to consumers artificially high. 29 c. the complete process: from anda to settlement due to the complexity of the interactions between the amendments, the medicare act, and the sherman act, it may be helpful to consider an example of the complete process, using the schering and upsher settlement as an exam­ ple. all other settlements discussed in this note took place under similar cir­ cumstances and in a similar fashion. schering owned the patent for the blood pressure medication k-dur 20 and its extended-release coating. the patent was scheduled to expire septem­ ber 5, 2006. 30 in 1995, upsher filed a paragraph iv anda with the fda, claiming that schering' s patent was either invalid or would not be infringed by upsher' s generic version. 31 schering promptly filed a patent infringement suit against upsher, triggering the thirty-month stay provided by the amendments.32 if a trial had taken place and if the court had found that schering' s patent was either invalid or not infringed upon, upsher would have been able to mar­ ket its generic version immediately. in addition, upsher would have enjoyed the 180-day exclusivity period, during which no other generic version ofk-dur 20 could be marketed. if, on the other hand, a court had found schering's k­ dur 20 patent to be valid, upsher would have been excluded from the market until the expiration of the patent in 2005. a court was never given the opportunity to decide the validity of the k­ dur 20 patent. in 1997, prior to trial, schering and upsher were able to reach a settlement agreement, which included the sharing oflicenses between the com­ panies and the payment of royalty fees from schering to upsher. 33 the compa­ nies agreed to delay upsher's entry into the market until september 1, 2001, nearly five years before expiration of the schering patent. 34 26. shennan act, 15 u.s.c.a § 1 (west 2007). 27. fazzio, supra note 3, at 24. 28. see fazzio, supra note 3, at 23-28. 29. see infra part n.b. 30. schering-plough corp. v. ftc, 402 f.3d 1056, 1058 (lith cir. 2005), cert. denied, 126 s.ct. 2929 (u.s. june 16, 2006). 31. id. at 1058-59. 32. id. at 1059. 33. id. at 1059-60. 34. id. at 1059. 162 indiana health law review [vol. 5:155 in march, 2001, the ftc filed suit against schering, upsher, and a third generic company which had also settled with schering, claiming that the two patent settlement agreements violated the sherman act because they prevented interbrand competition. 35 an· administrative .law judge found against the ftc, as did the eleventh circuit 36 the supreme court denied certiorari in july, 2006.37 as suggested, the patent exclusivity and market entry process can be ex­ tremely complex. for the purposes of this note, however, specific information about the patents involved will be irrelevant only the facts of the three liti­ gated settlement agreements discussed below will be considered, as they are best representative of the current debate.38 these courts have chosen a fact­ specific inquiry into the validity of patent settlement agreements, focusing gen­ erally on the anti competitive effects of the settlements. d. today 's pharmaceutical market: market incentives to settle patent infringement suits according to the centers for medicare and medicaid services, americans will spend $2,394 billion on heajth.care in 2008.39 of that amount, $247 bil­ lion will be spent on prescription drugs alone, making the pharmaceutical in­ dustry one of the most profitable industries in america.40 in this highly competitive market, however, profits ·are often not realized for years. the new drug development process is both costly and time-consuming and, as such, pharmaceutical companies carefully consider all new drug research and are al­ ways searching for new ways to protect their investments. according to the pharmaceutical research and manufacturers of america ("phrma"), a public policy advocacy group comprised of america's largest pharmaceutical compa­ nies, "[ o ]nly one of every 10,000 potential medicines investigated by america's research-based pharmaceutical companies makes it through the research and development pipeline" and is approved by the fda.41 in addition, phrma contends that gaining approval for a single drug and getting that drug to market 35. /d. at 1061. 36. /d. at 1061, 1076. 37. schering-plough cotp. v. f.t.c., 126 s.ct. 2929 (u.s. june 16, 2006). for more details regarding the schering settlement agreements, see infra part id.a. 38. schering-plough corp., 402 f.3d i 056 atl 058; job love v. barr labs, inc. (in re ta­ moxifen citrate antitrust litig.), 466 f.3d 187, 193-94 (2d cir. 2006) cert. denied, 127 s. ct. 3001 (2007); in re ciprotloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514 (e.d.n.y. 2005). see also infra part id. 39. u.s. dept. ofhealm&humanser.vlcfs,cir'sform:edicare&m:edicaidser.v's, realm care expenditures projections: 2007-2017, tbl 1, available at http://www.cms.bhs. gov/nationalhealthexpenddata!downloadslproj2007.pdf. 40. /d. at tbl. 2. 41. phrma, innovation, http://www.phrma.org/innovation (last visited mar. 15, 2008). 2008] closing the deal: patent setilement agreements 163 can take an average of fifteen years of research and development and can cost over $800 million. 42 critics ofthe pharmaceutical industry dispute these figures, which the in­ dustry often uses to explain the high cost of pharmaceutical drugs. for exam­ ple, marcia angell, former editor-in-chief of the new england journal of medicine, criticizes the industry figure, which was developed by the tufts cen­ ter for the study of drug development in 2001, as being impractically high due to problems with the center's calculations.43 she alleges that the real cost is closer to $265 million per drug, almost a quarter of the total estimated by the industry. 44 in an industry which is particularly secretive regarding the intricate details of its research and development information, angell used market infor­ mation to determine her own figures, simply dividing the amount of money spent by the industry on research and development in 2000 by the total number of new drugs introduced to the market that year.45 angell's formula, however, fails to consider that the cost· of drugs which make it to the market must also include the costs of researching those drugs and biological compounds which fail to reach the market or are abandoned even before reaching the fda ap­ proval process. indeed, due to the.nature of the industry, each drug which reaches the market must help recoup costs spent on research and development of both future drugs and failed drugs. further clarification of which figure is closer to the actual research and development cost of pharmaceuticals is better left to economists; however, it is clear from either figure that pharmaceuticals are a costly investment. as such, pharmaceutical companies spend millions each year attempting to protect and extend patents. according to angell, increasing efforts by pharmaceutical companies and changes in patent law have extended the effective patent life of brand name pharmaceuticals by six years since 1980.46 patent settlement agreements are becoming an increasingly popular form ·of protection for research and development investments. in 2005 alone, eleven patent settlement agreements. were made between brand name and generic manufacturers.47 of those, three included reverse payments to the generic manufacturer in order to restrict the generic version's market entry, onere­ stricted the generic's market entry with no compensation, and seven included no restrictions on market entry whatsoever.48 the current debate revolves largely around the first type of agreement, where generic manufacturers agree to 42. /d. 43. angell, supra note 2, at 41-46. 44. !d. at 40. 45. /d. at 39. 46. id. at 10. 47. bureau of competition, fed. 'i'rade comm'n, agreements filed with the federal 'i'rade commission under the medicare pr1lscription drug, improvement, and modernization act of 2003: summary of agreements filed infy2005, 1 (2006), available at http://www.ftc.gov/os/2006/04/fy2005drugsettlementspt.pdt: 48. !d. at 3-6. 164 indiana healm law review [vol. 5:155 delay market entry of their generic versions in return for some type of compen­ sation, often in the form of reverse payments. incentives for brand name manufacturers to settle patent infringement suits against generic manufacturers are high. prices of brand name drugs can fall as much as twenty percent once a generic enters the market, 49 and "[a ]s governments and regulators struggle to reduce the drugs bill for an ageing [sic] population, patients are being moved on to generics [sic] drugs faster than be­ fore .... "50 increasingly, out of court settlements are becoming a cheaper and more efficient way of defending pharmaceutical patents challenged by generic manufacturers, and "[s]ome drug giants [even] regard settlements as a way to bribe a generics firm to delay its introduction of a cut-price product. american antitrust officials worry this is to the detriment of the consumer."51 the ftc has resolutely challenged these settlements and today's pharmaceutical execu­ tives understand that such settlements need to be consumer-friendly in order to be approved by attorneys general and the ftc. 52 ill. the history of the debate while the validity of these settlements has been debated in courts in re­ cent years, the current debate was brought to the attention of the public-and the legislature-by the much-publicized agreements attempted by pharmaceuti­ cal giant bristol-myers squibb ("bms"). canadian generic manufacturer, apotex, recently introduced a generic version of bms's cash cow, plavix, which prevents blood clots and reduces the risk of heart attack and stroke. pla­ vix, "[w]ith sales of almost $13 million a day ... and growing ... is bms's most important drug by a long way. "53 in an attempt to keep apotex from cut­ ting into plavix's huge market share, bms's holding company, sano:fi, at­ tempted to settle with apotex twice, in hopes of keeping apotex's generic version off the market. 54 both settlements involved reverse payments to apo­ tex, in return for delayed entry of apotex's version. the attorney general, how­ ever, refused to approve either settlement, finding that the "states object to and will not approve the settlement agreement.'"5 after the attorney general's statement, the bms litigation focused on the validity of the plavix patent itself, culminating in a decision by the district court that the plavix patent was indeed valid. 56 although the bms patent set49. angell. supra note 2, at 174. 50. stephen foley, established patents threatened by aggressive generic drug firms, independent (u.k.), aug. 22, 2006, at 38. 51. under attack: drug patents, 1heeconomist (u.k), sept. 9, 2006, at 94. 52. foley, supra note 50. 53. ld. 54. sano:fi-synthelabov. apotex, inc., 488 f. supp.2d317,323-24(s.d.n.y),a.ff'd,470 f.3d 1368 (2nd cir. 2006), rehearing denied (jan. 19, 2007). 55. ld. at 324. 56. sano:fi-synthelabo v. apotex, inc. 492 f. supp. 2d 353, 397-98 (s.d.n.y. 2007). 2008] closing the deal: patent setilement agreements 165 tlement issue has effectively been dropped in the legal sphere due to the fact that neither settlement was approved, the fiasco caught both national and inter­ national attention, especially after bms chief executive officer peter dolan was dismissed by the company's board of directors, in part for his role in the ruined settlements. 57 with no litigation on bms 's settlement agreement, the current debate has centered around three main settlements between brand name companies and their generic challengers: schering's settlement with generic firms upsher and esi, zeneca's settlement with generic manufacturer barr, and bayer's settle­ ment with barr. a. schering-plough: patent settlement agreements with upsher and esi after generic manufacturers upsher-smith laboratories and esi lederle, inc. ("esf') sought approval to market generic versions of schering's high blood pressure medicine k-dur 20, schering entered into settlement agree­ ments with both companies. under its agreement with upsher, the earliest en­ try date for upsher' s generic version was set for september 1, 2001, five years before the k-dur 20 patent would expire.58 the settlement also included a three-part licensing deal for schering to market other upsher products, calling for schering to pay sixty million dollars in royalty fees, ten million in milestone royalty payments, and a ten to fifteen percent royalty on sales. 59 knowing that esi would be allowed to market its own version ofk-dur 20 once upsher's 180-day period of market exclusivity ended, schering attempted to settle with esi as well. the esi settlement allowed esi's generic to enter the market on january 1, 2004, a full two and a half years before the expiration of the k-dur twenty patent.60 in addition, schering agreed to pay esi ten million dollars, contingent on esi gaining fda approval by a certain date.61 after announcement of the settlement agreements, the ftc filed adminis­ trative complaints against all three companies, alleging illegal agreements in restraint of trade. 62 the eleventh circuit found both agreements to be valid stating: given the costs of lawsuits to the parties, the public problems associated with overcrowded court dockets, and the correlative public and private benefits of settle­ ments, we fear and reject a rule of law that would auto57. see stephanie saul, drug maker fires chiefo/5 years, n.y. times, sept. 13, 2006, atci. 58. schering-plough corp. v. ftc, 402 f.3d 1056, 1059 (11th cir. 2005), cert. denied, 126 s.ct. 2929 (u.s. june 16, 2006). 59. id. at 1060. 60. /d. 61. /d. at 1060-61. 62. id. at 1061. 166 indiana healtii law review matically invalidate any agreement where a patent­ holding pharmaceutical manufacturer settles an in­ fringement case by negotiating the generic's entry date, and, in an ancillary transaction, pays for other products licensed by the generic. 63 [vol. 5:155 the schering case was the first in this line of cases to be brought before the supreme court, in june, 2006.64 despite the controversy, the court denied certiorari, signaling its reluctance to involve itself in the issue at this time, and leaving the door open for congress to resolve the issue ofthe validity of patent settlement agreements on its own. 65 b. zeneca: patent settlement agreement with barr in 1985, generic pharmaceutical manufacturer barr requested fda ap­ proval to market a generic version of zeneca' s (now astrazeneca) premier can­ cer drug, tamoxifen. 66 after a district court found the tamoxifen patent invalid, and while appeal was pending, the two companies reached a settlement.67 un­ der the agreement, barr agreed to change its anda paragraph n certification to a paragraph iii certification, pushing back market entry of its own version of the drug until 2002, after the initial patent had expired. 68 in addition, zeneca agreed to pay barr twenty-one million dollars and awarded barr a non­ exclusive license to sell tamoxifen in the united states under barr's name.69 zeneca also paid barr's raw material supplier $9.5 million up front, plus an additional $35.9 million over ten years. 70 years later, while distribution oftamoxifen was being litigated in courts across the country, a class action suit was filed against zeneca and barr to chal­ lenge the settlement agreement.71 in 2003, the judicial panel on multidistrict litigation for the eastern district ofnew york found the settlement agreement valid and not a violation of the sherman act.72 in august 2006, the second circuit affirmed, finding that the agreement "did not unlawfully extend the 63. id. at 1076. 64. ftc v. schering-plough corp., 126 s.ct. 2929 (u.s. june 16, 2006). 65. id. 66. joblove v. barr labs, inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187, 193 (2d cir. 2006), cert. denied, 127 s.ct. 3001 (2007). 67. id. 68. jd. at 193-94. 69. jd. at 193. 70. id. at 193-94. 71. id. at 196. 72. joblove v. barr labs., inc. (in re tamoxifen citrate antitrust litig.), 277 f.supp. 2d 121 (e.d.n.y. 2003), qff'd, 466 f.3d 187, 196 (2d cir. 2006). 2008] closing the deal: patent settlement agreements 167 reach ofzeneca's tamoxifen patent.'m the supreme court denied certiorari in the case in june 2007. 74 c. bayer: patent settlement agreement with barr in 1997, generic manufacturer barr again settled a patent infringement claim, this time with bayer, manufacturer of the antibiotic ciprofloxacin ("ci­ pro").75 under the terms of the settlement, bayer paid barr $49.1 million in exchange for barr's agreement to amend its anda to a paragraph iii certifica­ tion, thereby allowing market entry of barr's generic version only after the ex­ piration of the cipro patent. 76 barr retained the option to re-amend its filing to paragraph iv if the patent was found to be invalid or unenforceable. 77 soon after the settlement was made public, a class action suit was filed against bayer and barr by direct and indirect purchaser class plaintiffs, claiming the settle­ ment violated state and federal antitrust laws. 78 in 2005, the district court found the agreements to be valid, stating: [t]he first element antitrust plaintiffs must prove is that the challenged agreements had an actual adverse effect on competition in the relevant market. here, plaintiffs have failed to demonstrate anti-competitive effects in the market for ciprofloxacin because, although the [a]greements undoubtedly restrained competition, they did not do so beyond the scope ofthe claims of the '444 patent.' 79 it should also be noted that both the cipro and the tamoxifen patents were held to be valid against subsequent challenges from generic manufactures who also filed paragraph iv and as. 80 the cipro patent alone was held valid in at least three subsequent suits, and a fourth challenger withdrew its paragraph iv certification soon after the third challenger lost.81 based on this subsequent history, it is unlikely that barr's challenges to either patent would have suc­ ceeded, making it unlikely that barr would have been successful in marketing 73. job/ave, 466 f.3d at 213. 74. joblove v. barr labs., 127 s. ct 3001 (u.s. june 25, 2007). 75. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 518-19 (e.d.n.y. 2005). 76. id. at 519. 77. id. 78. id.at517. 79. id. at 548. 80. i d. at 519-20; joblove v. barr labs, inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187, 195 (2d cir. 2006) cert. denied, 127 s. ct. 3001 (2007). 81. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d at 519-20. 168 indiana healm law review [vol. 5:155 its generic versions ofcipro or tamoxifen before the patents expired even in the absence of the settlements. as suggested by the settlements highlighted above, the courts have been reluctant to find patent settlement agreements invalid as violations of antitrust laws. their reluctance seems to stem from a wariness of per se rules, 82 and an idea that such settlements cannot be anti competitive when the generic entrant is not delayed past expiration of the pioneer patent. 83 these two themes have been the touchstones of the courts' reasoning and are explored below. iv. the details of the debate the bms settlement debacle, in addition to a recent outcry from con­ sumer groups fighting the rising cost ofhealth care, has brought the validity of patent settlement agreements to congress' attention .. congressional hearings beginning in the summer of 2006 have continued into the new legislative ses­ sion, spurred by the introduction of at least one bill attempting to resolve the issue. 84 the hearings, as well as recent articles and court decisions, provide insight into the arguments made on both sides ofthe debate. a. the arguments for senlement: the courts and the industry as suggested above, the incentives for pharmaceutical manufacturers to settle patent infringement claims are high. as such, the pro-settlement side of the debate has been led largely by pharmaceutical companies specializing in the research and development ofboth brand name and generic drugs. as antitrust litigation in the area has suggested, however, the courts have generally taken a pro-settlement view as well. their reasoning and the arguments of the pharma­ ceutical companies are explored below. 1. the courts' reasoning: consistently upholding settlement agreements as suggested by the schering, zeneca, and barr settlements, courts have been reluctant to find patent settlement agreements invalid or in violation of the sherman act. together, the three cases illustrate an emphasis by the courts on three main arguments for allowing patent settlement agreements: (1) courts should encourage settlement oflitigation;85 (2) the goal of patent law is not cir­ cumvented by allowing companies to enter into these settlements;86 and (3) the 82. schering-plough corp. v. ftc, 402 f.3d 1056, 1076 (11th cir. 2005), cert. denied, 126 s.ct. 2929 (u.s. june 16, 2006). 83. /d. at 1064. 84. preserve access to affordable generics act, s. 3582, 109th cong. (2006). 85. joblove, 466 f .3d at 202; schering-plough corp., 402 f .3d at i 072-73. 86. joblove, 466 f.3d at 202; in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d at 524. 2008] cwsing the deal: patent seti'lement agreements 169 existence of reverse payments does not render the settlement agreement inva­ lid.s7 the tamoxifen court clearly emphasized the benefits of encouraging set­ tlement over litigation. the court seemed to equate encouragement of settle­ ment with a kind of duty, stating that "[c]ourts are bound to encourage' the settlement oflitigation.'.s8 the court found that, when a legitimate patent con­ flict arises, such settlements are "'not precluded by the [sherman] act,' al­ though such a settlement may ultimately have an adverse effect on competition. "89 the court emphasized that a ''risk of loss in all appeals" en­ courages litigation participants to settle and that the right of settlement is not prohibited even in antitrust cases. 90 the eleventh circuit mirrored this senti­ ment in schering-plough, stating that patent owners should not be disallowed the right of settlement, which is available to all other litigants, simply due to their status as patent holders. 91 the courts also seem to agree that the ''ultimate goal of stimulating com­ petition and innovation" is not circumvented by allowing companies to enter into patent settlement agreements. 92 in fact, the second circuit specifically ar­ gued against a per se rule prohibiting such settlements, stating, "the increased number of continuing lawsuits that would result would heighten the uncertainty surrounding patents and might delay innovation."93 the court argued that pat­ ent settlements "promote efficiencies, resolving disputes that might otherwise block or delay the market entry of valuable inventions.',94 the district court hearing the cipro case also emphasized that patent settlement agreements do not contradict the goals of patent law, stating that any anticompetitive effects cannot be redressed by antitrust law when the effects do not extend past expira­ tion of the pioneer patent.95 the second circuit summarized this point, saying, ''the patent holder is seeking to arrive at a settlement in order to protect that to which it is presumably entitled: a lawful monopoly over the manufacture and distribution of the patented product."96 since the patent holder is simply pro­ tecting what it already legally owns, the court argues, such a settlement should be valid.97 87. joblove, 466 f.3d at 206-7; schering-plough corp., 402 f.3d at 1072. 88. joblove, 466 f.3d at 202 (quoting gamabale v. deutsche bank ag, 377 f.3d 133, 143 (2d cir. 2004)) (emphasis added). 89. !d. (quoting standard oil co. v. united states, 283 u.s. 163, 171 (1931)). 90. /d. at 205. 91. schering-plough corp., 402 f.3d at 1072. 92. joblove, 466 f.3d at 201. 93. id. at 203. 94. id. (quoting joseph f. brodley & maureen a. o'rourke, preliminary views: pat­ ent settlement agreements, anntrust, swnmer 2002, at 53). 95. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 523-24 (e.d.n.y. 2005). 96. joblove, 466 f.3d at 208-9. 97. !d. 170 indiana health law review [vol. 5:155 both the second and eleventh circuits agree that the existence of reverse payments does not render the settlement agreement invalid.98 in tamoxifon, the court asserted that the simple existence of reverse payments, without more, would not create a sherman act violation.99 the court even suggested that such a ban on reverse payments may be anticompetitive by reducing settlement options in patent cases and thereby reducing incentives to challenge patents altogether. 100 the eleventh circuit added in schering that the existence or size of a reverse payment should not dictate a decision, as "'even a patentee confi­ dent in the validity of its patent might pay a potential infringer a substantial sum in settlement. "'101 in sum, the courts have repeatedly ruled against a strict prohibition on pa­ tent settlement agreements, choosing instead to encourage settlement, and pro­ mote efficiency, innovation, and flexibility in litigation. the courts seem to be in agreement on the issue, with arguments of one court often mirroring the ar­ guments of other courts. their focus on innovation, and the fear that prohibit­ ing patent settlement agreements may impede innovation and investment, is echoed by the pharmaceutical industry itself. .. 2. the pharmaceutical industry: protecting investments through settle­ ment until recently, phrma had been oddly quiet on the issue of patent set­ tlement agreements, for the most part allowing the debate to take place only in the courtroom. congressional testimony on the issue in january, 2007, featured some of the biggest players in the debate, including phrma ceo billy tauzin. tauzin is a former u.s. representative (r-la) who chaired the house energy and commerce committee, which regulates the pharmaceutical industry, until his retirement from the house in december, 2004.102 his switch from public sector regulator of the industry to pharmaceutical ceo in the private arena drew caustic criticism from some congressional democrats. 103 despite the controversy surrounding his former affiliation with the house, tauzin has proven to be a powerful lobbyist for the pharmaceutical industry. in his testimony before the senate committee on the judiciary, tauzin touted the importance of patent protection for innovation, stating, "[p ]a tents provide the minimum degree of assurance for investors to risk the capital necessary to fund the pharmaceutical discovery process despite the uncertain chances of produc98. jd. at 206; schering-plougb corp. v. fi'c, 402 f.3d 1056, 1075 (11th cir. 2005), cert. denied, 126 s.ct. 2929 (u.s. june 16, 2006). 99. joblove, 466 f.3d at 206. 100. id. 101. schering-plough corp., 402 f.3d at 1075 (quoting valley drug v. geneva pharm., inc., 344 f.3d 1294, 1310 (lith cir. 2003)). 102. william m. welch, tauzin switches sides from drug industry overseer to lobbyist, usa today, dec. 16, 2004, at 4b. 103. /d. 2008] closing the deal: patent seti'lement agreements 171 ing a commercially viable product."104 he argued that a prohibition on settle­ ments would force both brand name and generic manufacturers to spend large amounts of time ,and money pursuing endless litigation, which might decrease costs allotted for research and development.105 further, he warned that those additional costs could be passed to consumers. 106 in addition to threatening innovation, tauzin warned that such prohibi• tions might also threaten generic drug development by reducing the incentive for generic manufacturers to challenge patents.107 with fewer options for end­ ing litigation, there are fewer incentives to enter into litigation in the first place. in addition, tauzin argued, the licensing rights often exchanged in patent set­ tlement agreements often lead to greater competition and flexibility in the market, giving physicians and consumers more choices when choosing pharmaceutical treatments.108 tauzin's business flexibility argument has been echoed by the media, as demonstrated by a september, 2006, economist article which stated, "[t]he costs and legal uncertainty associated with patent trials are simply too great."109 tauzin is not the only supporter in the pharmaceutical industry's camp. miles white, phrma member and chairman and ceo of pharmaceutical man­ ufacturer abbott laboratories, recently published an article in the financial times on the subject of patents. no white's argument emphasized two impor­ tant benefits of patent settlement agreements: innovation and business effi­ ciency. white argued that patent protection, in all forms, is essential for pharma­ ceutical companies to continue to create innovative products, arguing that intel­ lectual property protection has given rise to innovation and has even made innovation possible.111 recognizing the huge investment required to produce even one viable drug, white said, "genius alone is not enough."112 he argued that companies need the possibility for a return on investment in order to make any investment at all profitable or even possible.113 white also argued that new medications could be created only through continued innovation, and that con104. paying off generics to prevent competition with brand name drugs: should it be prohibited?: hearing before the s. comm. on the judiciary, 110th cong. (january 17, 2007) [hereinafter 2007 hearings], http://judiciary.senate.gov/hearing.cfm?id=2472 (statement of billy tauzin, ceo, phrma) (last visited apr. 9, 2008). 105. /d. 106. /d. 107. /d. 108. /d. 109. under attack: drug patents, supra note 51. 110. miles white, drug patents are good for our health, financial dmes (asia), nov. 30,2005, at 15. 111. id. 112. id. 113. id. 172 indiana health law review [vol. 5:155 tinued innovation must be encouraged and protected, even through the use of patent settlement agreements.114 not surprisingly, the arguments of the brand name manufacturers-that innovation requires protection and that settlement agreements provide business efficiency for the industry-are mirrored by their generic counterparts. in addi­ tion to these arguments, spokespeople for the generic phannaceutical industry have advanced some of their own theories. 3. the view of the generic manufacturers: a good business decision phrma and brand name manufacturers are not the only members of the pharmaceutical industry to support patent settlement agreements. indeed, ge­ neric manufacturers often gain as much, if not more, from these agreements. as bruce downey, chairman and ceo of barr pharmaceuticals, suggested in his congressional testimony, patent settlement agreements provide the "sole means by which the public can be guaranteed generic access prior to patent ex­ piration."m for instance, in both cipro and tamoxifen, at least three subse­ quent challengers lost their infringement cases against the pioneer manufacturer when the courts found the patents to be valid.116 as such, it is unlikely that barr's generic versions would have entered the market before expiration of the pioneer patents even if no settlements had been reached. citing the cipro and tamoxifen cases specifically as examples, downey explained that "barr[ ][comma omitted] was able to settle our litigation ... and secure early generic entry when four subsequent challengers all lost their cases. . . . in short, these settlements all provided value to the consumer that would not have been achieved if the generics had proceeded to litigate and lose."117 downey ex­ plained that, in essence, these settlements provided consumers with a generic version much earlier than would have been otherwise possible.118 without these settlements, which allowed market entry immediately upon expiration of the pioneer patents, barr would have been forced to wait until after expiration to even begin the approval process and may even have been forced to wait out another generic manufacturer's 180-day exclusivity period. while the settlements may have allowed earlier entry in these specific sit­ uations, evidence presented by the ftc suggests that barr may be in the minor­ ity. according to an ftc study, generics actually prevailed in seventy-three 114. id. 115. 2007 hearings, supra note 104 {statement of bruce l. downey, chairman & ceo, barr pharm., inc.). 116. in re ciprofloxacin hydrocloride anti1rust litig., 363 f. supp. 2d 514, 519-20 {e.d.n. y. 2005); joblove v. barr labs, inc. (in re tamoxifen citrate anti1rust litig.), 466 f.3d 187, 195 {2d cir. 2006) cert. denied, 127 s. ct 3001 (2007). 117. 2007 hearings, supra note 104 (statement of bruce l. downey, chairman & ceo, barr pharm., inc.). 118. id. 2008] closing tile deal: patent setilement agreements 173 percent ofparagraph iv infringement suits filed between 1992 and 2000.119 in addition, according to congressional testimony in 2002, consumers saved an estimated nine billion dollars after only four suceessful challenges by generic manufacturers.120 downey also contradicted arguments that, absent reverse payments, patent settlement agreements would include provisions for the generic drug to enter the market much earlier. he stated, "a monetary settlement [cannot] always be converted into a time period of early entry .... "121 he also suggested other con­ siderations, such as differing perspectives on the risks of litigation and chang­ ing future market conditions, might often impede settlement.122 in such cases where settlement cannot be achieved otherwise, monetary payments may help pave the way for generic drugs to enter the market before expiration of the pat­ ent, as in the schering case.123 like the courts, the pharmaceutical industry has focused its arguments on protection of innovation and the right to settlement. despite the persuasiveness of these arguments, the ftc and other consumer groups are not convinced, and have criticized such settlements both in the courts and before congress. b. the arguments against patent settlement agreements: the ftc and the consumer the other side of the debate-that which suggests patent settlement agreements are anticompetitive and hannful to consumers-is presented princi­ pally by the ftc, which has repeatedly taken the issue to the courts, only to lose. consumer groups, and even some lawyers, have added their concerns to those of the ftc. the concerns revolve around cost to consumers and the ma­ jor decrease seen in the price of brand name drugs when generics enter the market. 1. the ftc: protecting the consumer in july, 2006, ftc commissioner jon leibowitz testified before congress on the subject of generic pharmaceutical drugs and the barriers to market entry they often face. much of his testimony focused on patent settlement agree119. /d. (prepared statement of the fed. trade comm'n. presented by jon leibowitz, comm'r). 120. jaeger, supra note 2, at 12 (computing consumer savings basedongenericversionsof prozac ($2.5 billion), zantac ($2.45 billion), taxol ($3.5 billion), relafen ($109 million), and plantinol ($1 billion)). 121. 2007 hearings, supra note 104 (statement of bruce l. downey, chairman & ceo, barr pbann., inc.). 122. /d. 123. schering-plough corp. v. frc, 402 f.3d 1056, 1059-60 (11th cir. 2005), cert. de­ nied, 126 s.ct. 2929 (u.s. june 16, 2006). 174 indiana heal til law review [vol. 5:155 ments and the reasons behind the ftc's continuing attempts to strike down such settlements. •·· .· in his testimony, leibowitz emphasized that generic drugs are an indis­ pensable part oflowering prescription drug costs to consumers.124 specifically, leibowitz said, generic drugs saved consumets$8-1 0 billion in 1994 alone. 125 leibowitz argued that since patent settlement agreements often include a defer­ ral of market entry of generic drugs these settlements ultimately cost consum­ ers.t26 due to these perceived high costs, leibowitz argued for congress to con­ sider a ban on all patent settlements which include reverse, or exclusionary, payments. while he recognized the business benefits of such settlements, lei­ bowitz argued; "consumers lose the possibility of an earlier generic entry, either because the generic company would have prevailed in the [infringement] law­ suit or the parties would have negotiated a settlement with all·earlier entry date but no payment."127 liebowitz specifically criticized the courts' position on the issue; arguing that the schering and tamoxifen decisions wilt decrease generic competition, creating further costs to ~sumers, insurers, and employers. 128 in addition, leibowitz argued tha~ despite the remedy to the bottleneck problem contained in the medicare act. recent court decisions have effectively eliminated the medicare act's solution.129 under this act. subsequent generic filers may remove the initial bottleneck caused by the first filer's 180-day ex­ clusivity period by obtaining a court decision finding the pioneer patent invalid or not infringed.130 the district of columbia circuit, however,.recently found that the ftc need not treat "dismissal of a declaratory judgment action as a court decision sufficient to trigger the excllisivity period," effectively blocking subsequent filers from obtaining any such judgment in absence of an infringe­ ment suit by the pioneer manufacturer, and leaving subsequent filers with no mechanism to relieve the bottleneck.131 after the court's decision, any brand name manufacturer who wishes to keep the bottleneck in place simply has to refrain from suing subsequent filers. in his testimony, liebowitz purposed a simple fix to the bottleneck problem, asking congress to "clarify that dismissal of an action brought by a generic applicant seeking a declaratory judgment con124. barriers to generic entry: prepared statement of the federal trade commission before the s. spec. comm. on aging, 109th cong. 1 (july 20, 2006) [hereinafter 2006 hear­ ings], available at http://www.ftc.gov/os12006107/p0521 03barrierstogenericentrytesti monysenate07202006.pdf (statement of jon leibowitz, comm'r, fed. trade comm'n. 125. id. at 2. (citing cong. budget office, how increased competition from generic drugs has affected prices and returns in the pharmaceutical industry (july 1998)). 126. /d. at 12. 127. /d. 128. /d. at 16-17, 19. 129. id. at 20. 130. id. at 21. 131. tevapharm. usa, inc. v. fda. 441 f.3d 1 (d.c. cir. 2006). 2008] closing the deal: patent setilement agreements 175 stitutes a forfeiture event for the 180-day exclusivity period."132 in other words, any dismissal of a declaratory judgment would clear the bottleneck, allowing subsequent generic filers to begin marketing their own versions of the pioneer drug. leibowitz presented testimony to congress on the subject again in janu­ ary, 2007, this time before the senate committee on the judiciary.133 lei­ bowitz's comments echoed those made in his july, 2006, testimony and he again asked congress for a legislative remedy.134 2. consumer groups and other interested parties some consumer groups have added their concerns to those expressed by the ftc. in particular, consumers union (the "union"), the nonprofit pub­ lisher of consumer reports, has joined the :fray with congressional testimony that mirrors the arguments of leibowitz.13s union project director, michael wroblewski, specifically stated that the union supports congressional action on the issue, arguing that patent settlement agreements "jeopardize the health of millions of americans who have difficulty obtaining safe ~d effective medi­ cines at affordable prices."136 whil~ recognizing that economics offer powerful incentives for companies to enter such settlements, wroblewski echoed lei­ bowitz's argument that settlements decrease generic competition because, in the absence of reverse. payments, generic drugs may have been able to enter the market earlier, through different settlement options or the invalidation of the pioneer patent.137 wroblewski also argued that such patents are contrary to the purpose of the hatch-waxman amendments, relying on statements from sena­ tor orrin hatch (r-ut), one of the sponsors of the act.138 during recent de­ bates, senator hatch said, "[w]e did not wish to encourage situations where payments were made to generic firms not to sell generic drugs and not to allow multi-source competition."139 additionally, wroblewski argued that the second and eleventh circuits relied on false assumptions in the schering and tamoxifen cases. 140 he argued that, contrary to the courts' view, settlements could be found illegal without requiring that the pioneer patent be invalid.141 in addition, he argued that poli132. 2006 hearings, supra note 124, at 23 (statement of jon leibowitz, comm'r, fed. trade comm'n). 133. 2007 hearings, supra note 104 (preparedstatementofjonleibowitz, comm'r, fed. trade comm'n). 134. ld. 135. id. (statement of michael wroblewski, project dir., consumer educ. & outreach, consumers union). 136. ld. 137. ld. 138. id. 139. ld. (quoting senator orrin hatch). 140. ld. 141. id. 176 indiana health law review [vol. 5:155 cy which encourages settlement should not outweigh policy which encourages generic entry, especially when such policy has been codified by congress. 142 wroblewski, speaking on behalf of the union, also called for congress to re­ move the 180-bottleneck problem, as suggested by liebowitz.143 v. making the call: the best option for congress in the absence of a supreme court decision, congress is being called on to enter the fray. with arguments on both sides, legislators are facing a difficult decision: address the issue of patent settlement agreement validity, or simply leave the issue to the courts to decide. if congress takes the former route, it faces another important decision: whether or not such settlements should be valid in all cases or only in limited circumstances or if patent settlement agree­ ments should be banned across the board. a. the call for congressional action congressional action on the issue of patent settlement agreements is being called for on all fronts. the supreme court's denial of certiorari in the scher­ ing case left the ftc, and the consumers it seeks to protect, without remedy in the courts. the denial may be an indication that the court sees no need to in­ volve itself in the debate, or that it feels that district and circuit courts have shown themselves competent to rule on these issues. on the other hand, the supreme court's denial may also be seen as an indication that the court is de­ ferring to the legislature to make any changes in the law-an indirect sugges­ tion that congress rule on the issue. the lower courts are also calling on congress for help. for example, the district court in cipro specifically stated that any readjustments in patent law should be addressed by congress, rather than the courts.144 as leibowitz's congressional testimony demonstrates, the ftc is also calling for congressional action on the issue. at a 2006 forum, leibowitz rec­ ognized that congress had chosen to intervene in the issue in the past, and sug­ gested that it do so again. 145 more recently, in his january, 2007, testimony, leibowitz gave specific reasons for a need for congressional guidance, calling patent settlement agreements "a matter of pressing concern."146 he cited the 142. jd. 143. id. 144. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 548 (e.d.n.y. 2005). 145. jon leibowitz, comm'r, fed. trade comm'n, address at the second annual in­ house counsel's forum on pharmaceutical antitrust: exclusion payments to settle pharma­ ceutical patent cases: they're b-a-a-a-ck! 9 (april 24, 2006), available at http://www.ftc. gov/speeches/leibowitz/060424pharmaspeechaci.pdf. 146. 2007 hearings, supra note 104 (prepared statement ofjon leibowitz, comm'r, fed. trade comm'n). 2008] closing the deal: patent settlement agreements 177 need for a swift remedy, and stated that, since this has been treated as a policy issue, congress should set guidelines based on its authority to delineate pol­ icy.147 repeating a statement made in his july, 2006, testimony, the commis­ sioner made the ftc's support oflegislation very clear, stating, "[a] law must be broad enough to prevent evasion or other anticompetitive practices that could render the legislation ineffective, but it should avoid unwarranted deter­ rence to settlement of suits."148 in the past five years, almost half of the country's most-prescribed phar­ maceuticals have faced generic competition for the first time. 149 by 2012, twenty blockbuster drugs will face patent expiration or will lose market exclu­ sivity.150 the implications for pharmaceutical company profits, and consumer savings, are staggering. congress must address this issue now, before more patent settlement agreements are reached and challenged, and subsequently tied up in years of endless litigation. b. congress' options: codification, legislation, and limitation given the clear call for congressional intervention, it is likely that con­ gress will respond in the upcoming legislative sessions. hearings on the sub­ ject have already begun, leaving only the question of what action congress might take. congress' first option, of course, is to do nothing-to simply ignore the debate and allow the courts to continue to adjudicate challenges to settlement agreements as they have been doing. this is the option suggested by the phar­ maceutical industry. in his january, 2007, congressional testimony, tauzin suggested that a legislative remedy would be inappropriate and that "enforce­ ment agencies and courts should continue to evaluate patent settlements on a case-by-case basis."151 tauzin argued that courts are in the best position to de­ cide issues of harm to consumers, and that ftc challenges to anticompetitive settlements keep the industry from abusing the settlement option. 152 however, congress has shown no intention ofleaving this issue to the courts. the medi­ care act and recent hearings on the subject both suggest that this is an area of continuing concern for congress, and indicate that congress will not likely choose to remain silent on the issue. another option available to congress is to limit patent settlement agree­ ments, making them valid in only certain, narrow situations. however, the cur­ rent limitations imposed by the courts-that the infringement claim be "neither 147. jd. 148. jd.; see also 2006 hearings, supra note 124, at 20 (statement of jon leibowitz, comm'r, fed. trade comm'n). 149. jaeger, supra note 2, at 13. 150. jd. 151. 2007 hearings, supra note 104 (statement of billy tauzin, ceo, phrma). 152. jd. 178 indiana health law review [vol. 5:155 a sham nor otherwise baseless"1s3 and that the settlement does not"[ constrain] competition beyond the scope of the patent"154 -are already sufficiently narrow to allow settlements only when the protection provided by patent law is not be­ ing contravened. it is likely that any further limitations would effectively pro­ hibit settlement agreements. congress could also choose to codify the courts' decisions, in order to avoid ftc challenges and the years of litigation they create, accepting the courts' arguments that such agreements do not constitute antitrust violations. if congress chooses this option, it is anticipated that the current limitations would be codified, creating a legislative requirement that settlement be valid only as long as the infringement claim is not a sham and the settlement does not defer market entry past the expiration of the patent this choice could also include the ftc's suggestion of clarification for the 180-day exclusionary period in order to prevent further bottleneck problems. finally, congress could choose to ban patent settlement agreements alto­ gether. in fact, this option has already been given some congressional consid­ eration. in january, 2007, senator herb kohl (d-wi) introduced the preserve access to affordable generics act tss the act prohibits any agreements be­ tween brand name manufacturers and generic manufacturers when, "(a) an anda filer receives anything of value; and (b) the anda filer agrees not to research, develop, manufacture, market, or sell the anda product for any pe­ riod of time. "156 in essence, the bill would prohibit all settlements in which a generic manufacturer receives compensation in return for a delay in market en­ try. the bill is still in committee and is unlikely to come to a vote in the near future; however, it has gained support at least from the ftc. in his january, 2007, testimony commissioner leibowitz specifically supported the bill, stat­ ing, "the commission strongly supports the intent behind the bipartisan legis­ lation introduced by senators kohl, leahy, grassley, and schumer.''157 the ftc is not alone in its support of such a bright-line rule. merril hirsh, partner in a large washington, d.c.law firm which represents clients on both sides of the issue, testified before congress that a bright-line rule "is the simplest, most efficient and fairest solution to the patent lawsuit issue.''is8 hirsh argued that such a rule is the only way to promote the purpose of the 153. joblove v. barr labs. inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187, 208 (2d cir. 2006) cert. denied, 127 s. ct. 3001 (2007). 154. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 540 (e.d.n.y. 2005). 155. preserve access to affordable generics act, s. 316, lloth cong. (2007) (co­ sponsored by senators brown (d-oh), durbin (d-il), feingold (d-wi), grassley(r-ia), john­ son (d-sd), kennedy (d-ma), leahy (d-vt), obama (d-il) and schumer (d-ny)). an ear­ lier version of the bill, introduced to the 1 09th congress, died in committee. preserve access to affordable generics act, s. 3582, 109th cong. (2006). 156. s. 316. 157. 2007 hearings, supra note 104(preparedstatementofjonleibowitz, comm'r,fed. trade comm'n). 158. !d. (statement ofmerril hirsch, partner, ross, dixon & bell, llp). 2008] closing the deal: patent seitlement agreements 179 hatch-waxman act. she argued that without reverse payments on the table, generic companies will challenge patents only when they genuinely believe they will be successful, giving both companies incentive to settle at arms-length.159 a bar against reverse payments, she argued, will encourage efficient litigation, by decreasing the incentive of generic companies to challenge all pioneer pat­ ents. 160 finally, hirsch argues that reverse payments are anticompetitive be­ cause they may be used by brand name pharmaceutical companies to delay all generic entry, not just the ftrst or second competitors.161 even some outside the judicial and legislative system support a bright-line rule against patent settlement agreements which include reverse payments. a recent new york times editorial on the subject called for a "bright-line prohibi­ tion against making any payments to delay introduction of a generic drug."162 the editorial suggested that the industry needs a clear standard that would al­ low consumers to benefit from generic competition.163 a bright-line rule, however, is opposed by both the courts and the phar­ maceutical industry. the courts suggest that such a rule would contravene both patent law and the right of parties to settle litigation outside of the courtroom. as the second circuit stated, "such a requirement would be contrary to well­ established principles of law .... it is too late in the journey for us to alter course."164 tauzin spoke out against such a prohibition as well, stating, "that kind of rule is overbroad and would chill all settlements--even those that allow generic entry before patent expiration or contain other provisions that facilitate the availability of products to help patients live longer, healthier lives."165 c. the right choice: codification, with limits given the policy implications, as well as the implications for consumer costs, congress must provide the industry, and the ftc, with an answer to this issue. congress should choose to codify the courts' position, effectively pro­ hibiting ftc intervention in any future settlements of this kind. as mentioned above, this codification would allow brand name and generic pharmaceutical manufacturers to enter into patent settlements agreements as long as (1) the in­ fringement claim is "neither a sham nor otherwise baseless"166 and (2) the set­ tlement does not "[constrain] competition beyond the scope of the patent."167 159. /d. 160. /d. 161. /d. 162. editorial, return of the drug company payoffs, n.y. times, jan. 24, 2007, at a20. 163. /d. 164. joblove v. barr labs, inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187, 212 (2d cir. 2006) cert. denied, 127 s. ct. 3001 (2007). 165. 2007 hearings, supra note 104 (statement of billy tauzin. ceo, phrma). 166. joblove, 466 f.3d at 208. 167. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 540 (e.d.n.y. 2005). 180 indiana healrn law review [vol. 5:155 as the courts have found, when these two criteria are satisfied, patent settle­ ment agreements do not violate antitrust laws and should be valid. first, limiting or prohibiting settlement agreements contradicts the basic legal theories that settlement is to be encouraged and that businesses are to have the ability to contract when there are no anticompetitive effects. as the courts have suggested, encouraging settlement is a tenet of the american legal system. the right to settle should not be precluded because a pharmaceutical patent exists. indeed, owners of non-pharmaceutical patents still enjoy this right. further, patents themselves are anticornpetitive, giving the holder a legal monopoly for a certain period of time. if pharmaceutical companies are awarded patents, they should be allowed the opportunity to protect those pat­ ents until expiration, or until the patent is found to be invalid. only when the patent expires or is found invalid is the monopoly no longer legal. it is only at this point that anticompetitive effects are felt if generic companies continue to avoid market entry. brand name and generic pharmaceutical companies should therefore be free to contract together until this point is reached. second, prohibition or further limitation of settlement agreements may cause a chilling effect on pharmaceutical innovation. while the benefits of ge­ neric drugs to consumers are not debated, a loss of innovation would be devas­ tating to the american health care system. costs of patent litigation and inability to protect patents through settlement may cause pharmaceutical com­ panies to spend less on research and development, thereby decreasing the num­ ber of new drugs introduced to the market each year. if companies are denied opportunities to protect their innovation, they will have little incentive to en­ gage in innovative activities. a decrease in innovation would likely result in the introduction of fewer pioneer drugs and, by implication, fewer and more costly generic drugs. ultimately, consumers would be harmed by a decrease of innovative drugs, as many diseases and health issues may go un-researched and untreated. in addition to threatening innovation, prohibiting patent settlement agree­ ments may also delay the entry of some generic drugs past the point of delay agreed to by settlement. as suggested by the barr examples, settlements occa­ sionally invite generic drugs to the market even in situations where the pioneer drug is found to be valid by the courts. in addition, the schering case demon­ strates that some generic drugs will be given access to early market entry through settlement. settlements often provide generic companies with licenses to market drugs to which they would not have had access otherwise. thus, prohibiting settlements could remove these opportunities for generic manufac­ turers, thereby denying consumers access to cheaper versions of these drugs. third, prohibiting settlement could lead to further costs to consumers. the ftc's consumer-based arguments fail to consider the extra costs of litiga­ tion, which may be passed on to consumers by both brand name and generic manufacturers. patent litigation often continues for years, costing each side millions of dollars. if settlement is no longer an option, litigation costs will 2008] cwsing the deal: patent setilement agreements 181 continue to escalate. eventually, parties to such litigation may be forced to pass these high costs on to consumers in the form of higher prescription drug prices. higher litigation costs may also leave pharmaceutical companies with fewer resources to spend on initiatives which seek to reduce prescription drug costs and increase access to prescription drugs--two initiatives which undoubt­ edly should be supported by the ftc and consumer groups. one such initiative is the partnership for prescription assistance program ("ppa"), founded in 2005.168 the program, sponsored by phrma members, joins health care pro­ viders, community groups, and patient advocacy groups to provide uninsured or underinsured patients access to patient assistance programs.169 by november, 2006, the ppa had served more than three million people.170 such initiatives should be encouraged and could be compromised by increased litigation costs to pharmaceutical companies. as such, a bright-line rule against reverse payments should be discour­ aged. specifically, the preserve access to affordable generics act should not be passed. not only does the proposed act prohibit reverse payments, it effec­ tively prohibits all forms of compensation in cases where the generic agrees to a delayed entry date.171 without the possibility of consideration, there will be little incentive for either side to settle. especially given the high success rate of generic challenges, generic filers will be especially wary of any type of settle­ ment. in most cases, the generic will be willing to attempt litigation and hope the pioneer patent will be found invalid or not infringed, allowing the generic to enter the market immediately. this unwillingness to settle will likely lead to greater litigation costs and may even reduce opportunities for generics to enter the market early or to gain licenses for other brand name drugs. in cases such as cipro and tamoxifen, where the patents were found to be valid,172 the ge­ neric may be excluded from the market, as there will be little incentive to settle with the pioneer patent holder. indeed, in cases where the costs oflitigating an anda suit outweigh the potential profits, generic filers may be further dis­ couraged :from challenging the pioneer patent if the possibility of settlement is foreclosed. such a bright-line rule would be an "unwarranted deterrence to 168. press release, partnership for prescription assistance, unprecedented national pro­ gram to help millions of uninsured americans get the prescriptions medicines they need (apr. 5, 2005), https://www.pparx.org/press _ release.php?phpsessid=b30365fid79fe 156d6f5 020a56dbaf74 (last visited mar. 17, 2008). 169. par'inersidp for prescription assistance, program overview, https://www. pparx.orglabout.php (last visited mar. 15, 2008). 170. press release, partnership for prescription assistance, three million americans find help through partnership for prescription assistance (nov. 1, 2006), https://www.pparx.orgl ppa_milestone_3mil.php (last visited mar. 17, 2008). 171. preserve access to affordable generics act, s. 3582, 1 09th cong. (2006). 172. in re ciprofloxacin hydrocloride antitrust litig., 363 f. supp. 2d 514, 519-20 (e.d.n.y. 2005); job love v. barr labs, inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187, 195 (2d cir.2006) cert. denied, 127 s. ct. 3001 (2007). 182 indiana hea.lrn law review [vol. 5:155 settlement of suits," exactly what the ftc commissioner suggested should be avoided when creating legislation to address this issue.173 simply removing the possibility of reverse payments will not ensure that brand name companies will settle with generic manufacturers for an earlier en­ try date. as mentioned, a prohibition on reverse payments may decrease incen­ tive to settle at all. even if reverse payments are disallowed, however, and companies do fmd reasons to settle, there is no guarantee that either settlement or settlement for earlier entry will be reached other market considerations may impede settlement in these cases. contrary to hirsh's argument, 174 even in the absence of such a ban on set­ tlement compensation, patent settlement agreements involving reverse pay­ ments will not be available to every brand name manufacturer facing a generic challenger. from a business perspective, reverse payments are made when the amount of the payment is less than the amount of profits at risk if the generic manufacturer wins. this situation will often occur only with the first, and may­ be the second, challenger. business and market considerations will decrease the incentive to settle with each subsequent challenger until there is no incen­ tive left at all. once this point is reached, litigation will be the only option left to both companies. hirsh also argues that such a rule will encourage efficient litigation.175 it is unlikely, however, that generic manufacturers would re-evaluate which pio­ neer patents to challenge based on the absence of a possibility of receiving re­ verse payments. the success of most generic companies depends on challenging and winning patent infringement suits; thus many generics chal­ lenge any and all patents they deem to be profitable. this is unlikely to change, especially given the high success rate of such challenges. finally, as suggested by the ftc itself, bottleneck problems can be easily remedied by congress without prohibiting or limiting the availability of settle­ ment agreements. congress should amend the hatch-waxman act to clarify that a dismissal of a generic challenge to a pioneer patent would end the ge­ neric's 180-day exclusivity period. this simple amendment would end the bot­ tleneck problem and allow other generic companies to subsequently enter the market, increasing generic competition while still protecting the original patent vi. conclusion congress should allow patent settlement agreements in situations where the patent infringement claim is valid and where the period of exclusivity is not extended past patent expiration. in the pharmaceutical industry, investment and 173. 2007 hearings, supra note 104 (prepared statement of jon leibowitz, comm'r, fed. trade comm'n); see also 2006 hearings, supra note 124 (statement ofjon leibowitz, comm'r, fed. trade comm'n). 174. 2007 hearings, supra note 104 (statement ofmerril hirsh, partner, ross, dixon & bell, l.l.p.). 175. ld. 2008] closing the deal: patent setilement agreements 183 the possibility of recouping costs of those investments drive business plans for both brand name and generic manufacturers. patent settlement agreements al­ low industry participants to end litigation efficiently and quickly, and provide business stability to the industry. this stability allows pioneer companies to invest in cutting edge research, which provides consumers with innovative drugs. stability also helps generic manufacturers choose which drugs to target, allowing them to bring a greater variety of generic versions to consumers. sta­ bility plays a critical role in keeping pharmaceutical costs from sky-rocketing and protects the consumer from those rising costs. while consumer costs should always be a consideration for congress, congressional action should be taken based on facts. market issues and incen­ tives must be a factor in considering the issue of patent settlement agreements. in this case, stability and innovation must be protected in order to continue the success of the pharmaceutical industry. indiana iieaitb law review volumes 2008 articles dances with elephants: administrative resolution of medical injury claims by medicare beneficiaries achieving quality and responding to consumers the medicare beneficiary complaint process: who should respond? notes expanded hospital liability under the federal false claims act: an unexpected solution to the resident duty hour controversy a flawed solution to the sex offender situation in the united states: the legality of chemical castration for sex offenders live or let die: will the courts recognize in terminally m patients a fundamental right to choose non-fda approved drugs or does the fda's stringent approval process carry sufficient merit? closing the deal: making the right congressional decision about patent settlement agreements fellowsidp symposium issue 1 eleanor d. kinney wzlliam m. sage diane e. hoffman yuginia rowthorn robert r. elder matthew v. daley clayton r. portell amy c. waltz wellness in the law: state governments' role in addressing america's public health crisis october 5, 2007 program on law & state government indiana university school of law -lndillnopolis bottom lines and waist lines: state governments weigh in on wellness cynthia a. baker taking roll: an assessment of state and local governance of school wellness policies sally hubbard t indiana university school of law indianapolis iupui indiana health law review volumes executive managing editor mark e. douglas executive production editor lour j. britton clayton r. portell executive business editor jacob v. bradley note development editors matthew v. daley heather a. barnes billi j. lycett john p. taylor kyra r. wagoner joseph e. bruno meghan a. cox elizabeth g. currid ravinder s. deol brenda k. devries 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school. jeffrey 0. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. paul n. cox, vice dean and centennial professor of law. b.s., utah state university; j.d., university ofutah college oflaw; ll.m., university ofvirginia school of law. eric dannenmaier, associate professor of law. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university ( cand. ). james d. l>imrrri. clinical associate professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer. ann drobac, professor of law. b.a, m.a, stanford university; j.d., j.s.d., stanford law school. george e. edwards, carl m gray professor of law and director, program in international human rights law. ba, north carolina state university; j.d., harvard law sche><>l. frank emmert, johns. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university of munich law school; ll.m., the university ofmichigan law school; ph.d., university ofmaastricht; diploma, european university institute. nicholas georgakopoulos, harold r. woodard professor of law. ptyhion nomilds, athens university school of law; ll.m., s.j.d., harvard law school. frances watson hardy, clinical associate professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. johnlawrencehill, professor of law. b.a, northern illinois university; j.d., ph.d., georgetown university. linda kelly hill, m dale palmer professor of law. b.a., j.d., university ofvirginia. lawrence a. jegen, iii, thomas f. sheehan professor oft ax law and policy. a.b., beloit college; j.d., m.b.a., the university of michigan; ll.m., new york university school of law. henry c. karlson, professor of law. a.b., j.d., ll.m., university oflllinois college of law. robert a. katz, professor of law. a.b., harvard college; j.d., university of chicago law school. eleanor d. kinney, hall render professor of law, co-director of the williams. and christine s. hall center for law and health and executive director, latin american law program. b.a., duke university; m.a, university of chicago; j.d., duke university school oflaw; m.p.h., university ofnorth carolina. andrew r. klein, paul e. beam professor of law. b.a, university of wisconsin; j.d., emory university school of law. robert e. lancaster, clinical professor of law, director, chinese law summer program. b.a., millsaps college; j.d., tulane law school. norman lefstein, professor of law and dean emeritus. ll.b., university of illinois college of law; ll.m., georgetown university law school. maria p ab6n l6pez, associate professor of law and director, latin american law program. ba, princeton university; j.d., university of pennsylvania law school. gerard n. maouocca, professor of law. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor law. b.s., j.d., university of illinois. deborah mcgregor, clinical associate professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. mary h. mitchell, alan h. cohen professor of law. a.b., butler university; j.d., cornell law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. james p. nehf, cleon h. foust fellow and professor of law. b.a., knox college; j.d., university of north carolina law school. david orentucher, samuel r. rosen professor of law and co-director of the williams. and christine s. hall center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, associate professor of law. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kathleen patchel, associate professor of law. a.b., huntington college; j.d., university ofnorth carolina law school; ll.m., yale law school. michael j. pllts, associate professor of law. b.sj., northwestern university; j.d., georgetown university law center. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. ruhtenberg, clinical professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; jd., indiana university school of law-indianapolis. joelm. schumm, clinical associate professor of law. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university school of law­ indianapolis. lawrence p. wn.kins, william r. neale professor of law. b.a., the ohio state university; j.d., capital university law school; ll.m., university of texas school of law. lloyd t. wilson, jr., associate professor of law and director, central and eastern european law program. b.a., wabash college; m.a., duke university; j.d., indiana university school of law-bloomington. mary t. wolf, clinical professor of law and director of clinical programs. b.a., saint xavier college; j.d., university oflowa college of law. r. george wright, lawrence a. jegen iii professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law-indianapolis. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university of nebraska; ll.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., reoesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, ill, professor of law emeritus. a.b., j.d., m.a.l.s., the university of michigan. agnes p. barrett, associate professor of law emerita. b.s., j.d., indiana university. clyde harrison crocketi, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. falender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school oflaw-indianapolis. davida. funk, professor of law emeritus. a.b., college ofwooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of low emerita. b.s.j., northwestern university; j.d., university of colorado school oflaw. harold greenberg, professor of low emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of low emeritus. a.b., juniata college; j.d., george washington university law school. william f. harvey, carl m. gray professor of low&: advocacy emeritus. a.b., university ofmissouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of low emeritus, a.b., harvard college; j.d., rutgers university school oflaw-newark. william andrew kerr, professor of low emeritus. a.b., west university; b.s., duke university; j.d., ll.m., harvard law school. william e. marsh, professor of low emeritus. b.s., jd., university ofnebraska. ronald w. polston, professor of low emeritus. b.s., eastern dlinois university; ll.b., university of illinois college oflaw. kennem m. stroud, professor of low emeritus. a.b., jd., indiana university­ bloomington. james w. torke, carl m. gray professor of low emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of low emeritus. a.b., university ofiowa; j.d., ll.m., george washington university law school. law library faalty judflll ford anspach, professor of low and director, ruth lilly low library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. debra densla w, reference librarian. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university ofkentucky. wendell e. johnting, assistant director for technictji services. a.b., taylor university; m.l.s., indiana university. chris e. long, catalog librarian. b.a., indiana university; m.a., indiana university; m.l.s.; indiana university. steven r. miller. reference librarian. b.s., lebanon valley college of pennsylvania; m.a., dominican university; m.s., norlhwestem university; j.d., the john marshall law school. mahnaz k. mosjjfeoh. acquisition/serials librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy, associate director of low library. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyoshi otsu, automated and media services librarian. a.a., parkland college; a.b., m.s., c.a.s., university oflllinois. indiana health law review volumes issue 1 articles dances with elephants: administrative resolution of medical injury claims by medicare beneficiaries .............•. ...•.• eleanor d. kinney achieving quality and responding to consumers the medicare beneficiary complaint process: · william m. sage who should respond? .......................................................................... dian.e e. hoffinan · virginia rowthom . 9 notes expanded hospital liability under the federal false claims act: an unexpected solution to the resident duty hour controversy •. .•.••.•• robert r. elder 53 a flawed solution to the sex offender situation in the united states: the legality of chemical castration/or sex o.ffenders ••••.•.. matthew v. daley 87 live or let die: will the courts recognize in terminally ill patients a fundamental right to choose non-fda approved drugs or does the fda's stringent approval process carry sujjicient merit? ..........................................................................••..... clayton r. portell 123 closing the deal: making the right congressional decision about patent settlement agreements ................................................... amy c. waltz 155 fellowship symposium wellness in the law: state governments' role in addressing america's public health crisis october s, 2007 pro!j1'flm on law &: state government jndiantl university school of law -lndituulpolis bottom lines and waist lines: state governments weigh in on wellness ...........•....••...........•.••••..•....•....••....•... cyntbiaa. baker 185 taking roll: an assessment of state and local governance of school wellness policies ......................... .•..••.••.•... .sally hubbard 201 2008 karen a. jordan karen jordan is a professor of law at the brandeis school of law at the university of louisville. professor jordan joined the brandeis school of law faculty in 1993, following work at the indiana university school of law indianapolis, and a year in private practice. her research and teaching interests are primarily in the areas of health and administrative law, and civil procedure. professor jordan has published extensively on the topic of federal preemption of state health law and policy. additionally, she has presented at national conferences sponsored by the american society of law, medicine and ethics and the association of american law schools, and served as visiting professor for the health law and policy program at seton hall university school of law. karen jordan may be contacted at the following: phone: (502) 852-5292, or e-mail: karen.jordan@louisville.edu. recent modjfications to tile preemption docirine & their impact on sta'ie hmo liabh.ity laws karen a. jordan* iniroduction for years, significant attention has been devoted to problems arising from medical necessity determinations made by managed care organizations ("mcos") such as health maintenance organizations ("hmos"). that is, decisions by an hmo that medical services or treatments recommended by subscribers' treating physicians are "not medically necessary," and thus not covered by the hmo plan. when an hmo subscriber subsequently suffers injury or death as a consequence of a denial of coverage, legal barriers have precluded the subscriber from holding the hmo accountable for the negligent medical necessity determination. most predominantly, for many years the preemption provisions of the employee retirement income security act of 197 4 ("erisa")1 presented a formidable barrier to redress for such injuries for most subscribers who obtained their health coverage through employer provided benefit plans ("erisa plans").2 since 1995, however, the courts have painstakingly worked through the common law developments of the law of erisa preemption, and some lower courts have finally allowed lawsuits to proceed against hmos for negligent denials of coverage. 3 for example, in * professor of law, louis d. brandeis school of law at the university of louisville; j.d., 1990, summa cum laude, indiana university school of law-indianapolis. 1. employee retirement income security act of 1974, pub. l. no. 93-406, 88 stat. 832 (codified as amended at 29 u.s.c. §§ 1001-1461 (2003)). erisa's general preemption provision broadly preempts "any and all state laws insofar as they ... relate to any employee benefit plan." 29 u.s.c. § 1144(a) (2003). 2. id. § 1002(1). erisa defines employee benefit plans to include both pension and welfare benefit plans; welfare benefit plans include plans established or maintained by employers for the purpose of providing medical, surgical, or hospital care benefits. ld. § 1 003(b )(1 )-(5). erisa does not extend to certain plans, however. these plans include govern­ mental plans, church plans, excess benefit plans, plans maintained solely for the purpose of complying with applicable workmen's compensation, unemployment compensation or disability insurance laws, and plans maintained outside of the united states primarily for the benefit of persons who are non-resident aliens. id. see generally karen a. jordan, coverage denials in erisa plans: assessing the federal legislative solution, 65 mo. l. rev. 405 (2000). courts have historically found that erisa preemption extends to state law civil actions against hmos or other managed care entities if the claim asserted therein arises from a coverage determination even if the determination at issue was based on a finding that recommended treatment is not medically necessary. id. 3. seeciciov. does, 321 f. 3d 83 (2dcir. 2003)(holdingthatanegligenceclaimagainst an hmo challenging a medical decision by the hmo about appropriate treatment is not preempted by erisa§ 514). see also pappas v. asbel, 768 a.2d 1089 (pa. 2001). other courts have answered only part of the preemption issue. see, e.g., land v. cigna healthcare 54 indiana health law revlew [vol. 1:51 cicio v. does,4 the second circuit court of appeals held that erisa did not preempt an erisa plan beneficiary's medical malpractice claim against an hmo which made an allegedly negligent medical decision to deny medical care recommended by the claimant's treating physician. 5 the second circuit acknowledged that other courts addressing similar facts had concluded that "malpractice claims based on utilization review" are preempted because a medical necessity determination is "part and parcel" of a coverage determina­ tion.6 however, the court explained that those decisions had been rendered before the supreme court's "retrenchment of erisa preemption's margins;"7 and, in particular, before pegram v. herdrich,8 in which a unanimous court explained that a "mixed eligibility and treatment decision"-a utilization review determination based on medical necessity-"cannot be untangled from physicians' judgments about reasonable medical treatment."9 the second circuit, in cicio, construed pegram as "demonstrat[ing] that the mere presence of fla., 339 f.3d 1286 (11th cit. 2003) (using the same analysis as in cicio, but holding only that a medical malpractice claim against an hmo was not completely preempted, reserving the issue of§ 514 preemption to the state court); lazorko v. pa. hosp., 237 f.3d 242 (3d cit. 2000). 4. cicio, 321 f.3d at 83. 5. in cicio, the plaintiff decedent's physician, on january 28, 1998, had recommended ''high dose chemotherapy supported with peripheral blood stem cell transplantation, in a tandem double transplant, for [mr. cicio's] diagnosis of multiple myeloma." ld. at 87. the hmo's medical director, dr. spears, on february 23, 1998, denied the request for preauthorization of cicio's physician, dr. samuel. i d. at 88. dr. spears noted that the procedure was not covered because cico's health benefit plan stated that experimental or investigational procedures were not covered. ld. on march 4, 1998, after unsuccessful attempts to contact dr. spears by telephone, dr. samuel wrote an appeal for reconsideration, noting that the recommended treatment was a well-established and effective treatment. id. on march 25, 1998, dr. spears approved a single stem cell transplant, but again denied the original request for tandem stem cell transplant. ld. by march 25, 2003, cicio was no longer a candidate for the transplant. cicio, 321 f.3d at 88. mr. cicio died on may 11, 1998. ld. on appeal, the remaining claims challenged the timeliness of dr. spears' decisions, the allegedly misleading nature of the hmo' s representations about cicio's health benefit plan, and the quality of the medical decision made by the hmo and the physi¢an medical director, both of whom were named as defendants. id. at 90. ' interestingly. the court of appeals noted that the hmo' s abstract determination that a double stem cell transplant to treat the condition was experimental might lack the "significant application of medical judgment" and thus represent a decision simply about the scope of benefits. id. at 91. however, the court of appeals read certain allegations in the complaint as more clearly challenging the appropriateness of a medical decision by the hmo because dr. spears reviewed a thorough case history of mr. cicio's illness and the decision thus, could have rested on an analysis of the appropriate treatment for mr. cicio's specific condition. id. the court noted that, "[b ]y denying one treatment and authorizing another that dr. samuel had not specifically requested, dr. spears at least seems to have been engaged in a patient-specific prescription of an appropriate treatment .... " id. 6. cicio, 321 f.3d at 100 (citing corcoran v. united healthcare, inc., 965 f.2d 1321 (5th cir. 1992); jass v. prudential health care plan, inc., 88 f.3d 1482 (7th cit. 1996); totton v. am. biodyne, inc., 48 f.3d 937 (6th cit. 1995)). 7. cicio, 321 f.3d at 100. 8. pegram v. herdrich, 530 u.s. 211 (2000). 9. cicio, 321 f.3d at 100 (quoting pegram, 530 u.s. at 229). 2004] recent modifications rome preemption doctrine ss of an administrative component in a health care decision no longer has determinative significance· for purposes of preemption analysis when the decision also has a medical component."10 accordingly, the court held that § 514(a) of erisa did not preempt the claimant's medical malpractice claim because the claim simply did not ''relate to" erisa plans.11 the question of the day, however, is whether the supreme court will ultimately agree with this emerging perspective of the scope of erisa pre­ emption, including both the outcome and the analysis leading to the outcome. two recent cases shed some ·light on the answer to the question, but predictably, also raise new questions. continuing along the path begun in 1995,12 the supreme court in rush prudential hmo, inc. v. moran 13 ("rush") and kentucky association of health plans, inc. v. miller14 ("kahp"), drew additional lines marking the boundaries of the preemption of state law by erisa. more specifically, in both decisions the court broadened the scope of erisa' s "savings clause."1' further, the court in kahp streamlined the basic savings clause standards16 and the court in rush provided an intricate analysis, which ultimately limited or narrowed the scope of the conflict preemption exception to the savings clause.17 both opinions can readily be construed as drawing lines that are consistent with the path taken by the court in recent years, and consistent with the view held by many, that erisa should not be construed as preempting state law claims against managed care organizations for negligent medical necessity detenninations. however, the cases suggest an analysis that differs from that used in cicio and different from that advocated by some erisa scholars. 10. /d. at 103. 11. /d. at 104 ("[w]e conclude that§ s14 preemption does not obtain with regard to those claims predicated on the violation of a state tort law by a failure to meet a state-law defined standard of care in diagnosing or recommending tmdment of a plaintiff patient's constellation of symptoms."). 12. in 1995, the supreme court issued an erisa preemption decision that, for the first time, began detailing the limitations on the scope of erisa preemption. see n.y. state conference of blue cross &: blue shield v. travelers ins. co., 514 u.s. 645 (1995). see generally karen a jordan, travelers insurance: new support for the argument to restrain erisa pre-emption, 13 yale j. on reg. 255 (1996) (analyzing the travelers insurance decision and applying the more restrained view·to emerging preemption issues). 13. rush prudential hmo, inc. v. moran, 536 u.s. 355 (2002). 14. ky. ass'n of health plans, inc. v. miller, s38 u.s. 329 (2003). 15. through erisa's savings clause, congress expressly exempted from the reach of erisa preemption state laws that mgulate insurance. erisa' s savings clause prescribes that erisa shall not "be construed to exempt or relieve any person from any law of any state which regulates insurance .•.. " 29 u.s.c. § 1144(b)(2)(a) (2003). the supreme court traditionally has declared that erisa's savings clause should be broadly construed, but in reality has kept the scope of the exemption relatively d81tow. see supra notes 74-88 and accompanying text for a discussion on broadening. 16. see infra notes 89-123 and accompanying text 17. see infra notes lsl-96 and accompanying text 56 indiana healm law review [vol. 1:51 rather than avoiding preemption by a finding that state hmo liability laws do not impermissibly "relate to" erisa plans, rush and kahp suggest that the resolution of the issue ultimately may hinge on application of the conflict preemption exception. justice souter's opinion in rush, which was joined by a majority of the justices, seemed to clear the way for state hmo liability laws by carefully describing the holdings in key precedential cases in an effort to delimit the preemptive force of§ 502(a).18 unfortunately, despite justice souter's care, some language in the majority opinion could be construed as supporting. the exact opposite view: that rush supports erisa preemption of state legislative attempts to impose liability on managed care plans for violation of a duty of ordinary care in arranging for medically necessary services.19 indeed, that opposite view was highlighted in the december 2002 publication of the american bar association's health law section.20 accordingly, this article analyzes the kahp and rush refmements to the law of erisa preemption, highlights the key doctrinal and policy implications, and then applies the refinements to the question whether erisa preempts civil actions that are essentially "medical malpractice" lawsuits against mcos for negligent denials of claims based on "medical necessity determinations." as noted, the crux of the analysis may well hinge on application of conflict preemption principles and, specifically, on the court's view of the preemptive force of erisa' s civil enforcement provisions. this article concludes, using justice souter's analysis, that state hmo liability laws fall outside the scope of the preemptive force of§ 502(a). i. side bar: certiorari granted on the narrower "completion preemprion" issue notably, as this article was going to print, the supreme court granted certiorari in two consolidated cases in which aetna and cigna policyholders (calad and davila) sued their hmos for their alleged negligence or failure to use ordinary care in denying coverage for the medical care recommended by the claimants' physicians (hereafter the "davila case").21 in the cases, 18. see infra notes 275-93 and accompanying text. 19. see david m. humiston et al., navigating the shoals of erisa: the effect of erisa preemption on new state laws creating tort liability against managed care entities, 14 health law 1, 8 (2002) (opining that, even in light of pegram and rush, erisa preempts state statutory liability for delays and denials of requested benefits; although state laws holding hmos liable for negligent acts of agents or employees while providing direct medical services to plan participants will survive preemption). 20. gregory pimstone & michele johnson, rush prudential: savior of pilot life?, health law., dec. 2002, at 7. see infra notes 276-79 and accompanying text (describing the views set forth in this article). 21. see aetna health, inc. v. davila, 124 s. ct. 462 (2003); cigna healthcare of tex., inc. v. calad, 124 s. ct. 463 (2003). davila and calad filed complaints which expressly set forth claims based on state law-the law of negligence generally and the more specific hmo 2004] recent modifications to the preemption doctrine 57 however, the issue addressed in this article, § 514 preemption, is not squarely before the court. nonetheless, § 514 considerations may play a key role in the davila decision. in the davila case, the fifth circuit court of appeals held that the removal to federal court by aetna and cigna of the negligence-based actions filed by davila and calad was not proper.22 more specifically, the fifth circuit held that the claims of davila and calad did not fall within the scope of the "complete preemption" doctrine, a doctrine that allows the removal of actions involving state law claims due to the special preemptive force of certain federal laws. 23 the doctrine applies and allows removal if the state law cause of action falls "within the scope of§ 502(a)(1)(b)."24 mere preemption (a§ 514(a) defense) is insufficient to confer removal jurisdiction. importantly, although the § 514 issue is not squarely before the court, the § 514 preemption analysis may be implicated in two ways. first, if the court disagrees with the fifth circuit and finds that the cases were properly removed, the court necessarily also resolves the broader § 514 preemption question: a claim that is completely preempted is preempted and must be pursued, if at all, as a§ 502(a) claim. indeed, this has been the trend in the lower courts for years. for example, in corcoran v. united healthcare, inc.,25 the fifth circuit held that erisa preempted a state law negligence claim against an hmo arising out of a medical necessity determination. the corcoran holding was primarily guided by the supreme court's statement in pilot life insurance co. v. dedeaux, 26 in which the court first emphasized § 502(a)'s role in the preemption analysis. in pilot life, the court stated that § 502(a)(l)(b) provides the exclusive vehicle for claims alleging improper liability law enacted by the legislature of texas. davila, 124 s. ct. at 462; calad, 124 s. ct. at463. 22. see roark v. humana,lnc., 307 f.3d 298, 306-08 (5th cir. 2002), cert. granted sub. nom., aetna health, fuc. v. davila, 124 s. ct. 462 (2003); cigna healthcare of tex., inc. v. calad, 124 s. ct. 463 (2003). 23. thus, although calad and davila chose to bring claims created by or based on state law, their actions would nonetheless be removable if they fell within the scope of the complete preemption exception. under the general rules, an action is removable only if the action is one that could have been filed in federal court. 28 u.s.c. § 1441 (2003). generally, then, an action between non-diverse parties would not be removable unless the action involved a claim falling within "federal question" jurisdiction. ld. under the long-established ''well-pleaded complaint" rule, whether a claim falls within federal question jurisdiction depends on whether the plaintiffs stated claim or cause of action is created by or based on federal law. see louisville & nashville r.r. v.motley,211 u.s.149,152(1908). afederalissueraisedbythedefendantasadefense, or a defense anticipated by the plaintiff and expressly raised in the complaint, is insufficient to support an exercise of federal question jurisdiction. ld. the complete preemption doctrine is an exception to the general removal rules. ld. 24. see metropolitan life v. taylor, 481 u.s. 58 (1987). see also beneficialnat'l bank v. anderson, 539 u.s. 1 (2003) (involving preemption by the national bank act); franchise tax bd. v. constr. laborers vacation trust, 463 u.s. 1 (1983) (involving erisa preemption). 25. corcoran v. united healthcare,lnc., 965 f.2d 1321, 1331 (5th cir. 1992). 26. pilot life fus. co. v. dedeaux, 481 u.s. 41 (1987). 58 indiana health law review [vol. 1:51 processing of a claim for benefits. 27 the court in corcoran held that, although a denial based on "no medical necessity" is different from a pure coverage decision of the type in pilot life, the medical decision is still made as "part and parcel" of a benefit determination; thus, the concorans' claim fell within the scope of§ 502(a)(l)(b)'s preemptive sweep.28 under that rationale, courts have found actions such as those in davila as being removable via complete preemption and preempted. similarly, although the third circuit in dukes v. u.s. healthcare, inc. 29 refined the test for complete preemption to carve out removal of claims challenging the ''quality" of care provided, the court adhered to the view in corcoran that § 502(a)(1 )(b) of erisa preempts and thus completely preempts a claim arising from a denial of benefits. 30 so, if the court finds that the claims in davila are within the complete preemption doctrine and thus properly removed, the court will also resolve the § 514 preemption issue. second,§ 514 preemption may also be implicated if the court agrees with the fifth circuit's approach in davila and finds that the cases were not properly removed. the implication is not necessary or absolute, however, given that the court could simply affirm the appropriateness of remand­ which would leave the issue of§ 514(a) preemption to the state court. the issue of§ 514(a) preemption remains because the scope of state law causes of action completely preempted due to § 502(a) is not necessarily co-extensive with the scope of state law causes of action preempted by § 514(a) or preempted due to a mere conflict with § 502(a). · rather, courts have repeatedly recognized, even beyond the context of erisa, that state claims that are not completely preempted may nonetheless be preempted. for example, the third circuit in dukes explained that, although not removable under the complete preemption doctrine, state negligence claims challenging the quality of care provided by an hmo to an erisa plan participant might nonetheless be preempted by erisa.31 nonetheless,§ 514 preemption may well play a key role in the court's complete preemption analysis given the existence of an important corollary. state claims that are not preempted are also not completely preempted. this corollary is important because of one aspect of the recent supreme court cases highlighted in this article-the majority's narrowing of the preemptive force of§ 502(a) in rush prudential as is explained in part id(a)(1) of this article. the narrower view of§ 502(a) adopted by the majority in rush suggests that at least some of the justices lean towards the position that congress did not intend for erisa to preempt claims against hmos challenging allegedly negligent medical necessity determinations, even when the claims are brought 27. /d. at 56-57. 28. corcoran, 965 f.2d at 1332. 29. dukes v. u.s. healtbcare, inc., 57 f.3d 350 (3d cir. 1995). 30. /d. at 357. 31. /d. 2004] recent modifications to the preemption ooci'rine 59 by erisa plan participants and beneficiaries and are asserted against entities such as hmos which serve as administrators of erisa health benefit plans. if that view prevails in the davila case, § 514(a) preemption considerations may drive the decision of the complete preemption issue. that is, although not squarely before the court, the davila opinion may reflect the position (fleshed out later in this article) that§ 514(a) does not preempt the claims of calad and davila-and thus, a fortiori, the claims also are not completely preempted and remand was proper. 32 32. although it is beyond the scope of this article to thoroughly address the complete preemption issue, the author believes the case law favors davila and calad. notably, the supreme court cases do not expressly discuss how to determine whether a state claim is within the scope of§ 502(a). nonetheless, the supreme court cases addressing complete preemption have impliedly answered the question. for example, in franchise tax board v. construction laborers vacation trust, 463 u.s. 1 (1983), the court held that, although erisa may support complete preemption, it was not available in that case because the claim by the state was not within the scope of§ 502(a). franchise tax board involved an action by a state tax enforce­ ment agency brought in state court against a multi-employer trust that had been established to administer a collective bargaining agreement. /d. the claim was not within the scope of § 502(a) because § 502(a) does not create a cause of action in favor of state governments to enforce tax levies. rather, § 502(a) creates various causes of action for plan participants or beneficiaries, plan administrators or fiduciaries, or the secretary of the department of labor, to be brought against plan administrators or fiduciaries to enforce rights under the terms of the plan or rights under erisa see 29 u.s.c. § 1132(a) (2003). in franchise tax board, the claimant's cause of action did not even come reasonably close to duplicating or looking like a cause of action authorized by § 502(a). franchise tax bd., 463 u.s. at 1. in other supreme court cases addressing complete preemption, the claimants stated causes of action, which clearly did fall within the scope of the relevant federal statute. for example, in metropolitan ufe v. taylor, 481 u.s. 58 (1987), the case in which the court expressly held that the preemptive force of erisa also supports complete preemption removal, the plaintiff sought re-implementation of disability benefits and insurance coverage, as well as damages for "money contractually owed." ld. at 61. as such, the plaintiff's claim clearly duplicated the cause of action explicitly authorized by erisa-§ 502(a)(l)(b) provides a vehicle to protect a plan participant's contractual rights to benefits. although the plaintiff also sought additional remedies beyond those allowed by erisa, the claim was still within the scope of§ 502(a)(l)(b). the same was true in beneficial national bank v. anderson, 123 s. ct. 2058 (2003), the court's most recent complete preemption case in which the court extended the doctrine to the claims within the scope of the national bank act. in that case, the plaintiff sought, through a claim based on a state usury law, damages from a national bank for allegedly charging excessive interest. yet, the national bank act governs the rate of interest that a national bank may lawfully charge and provides a private right of action for certain remedies against national banks that charge an excessive rate. see id. at 2061 (citing the national bank act, 12 u.s.c. §§ 85-86 (2003)). thus, the federal statute protects the right to a "non-excessive" interest rate and the plaintiff's state law claim in beneficial national bank clearly duplicated the cause of action provided by the federal statute to protect that right. as in taylor, although the plaintiff also sought remedies not allowed by the federal statute, removal was deemed proper. the davila and calad claims fall somewhere between the claims in the supreme court cases. that is, on the one hand they are not so clearly not within the scope of§ 502(a) as the claim in franchise tax board. rather, several aspects of the claims make them resemble a§ 502(a)(l)(b) claim. state negligence-type claims of the sort in davila are claims brought by erisa plan participants and beneficiaries against hmos that serve as administrators or fiduciaries of the erisa plan through which the plaintiffs' health coverage is provided. 60 indiana healtii law review [vol. 1:51 it. introduction to .kahp and rush and the preemption issues both rush and kahp involved erisa preemption challenges to state laws enacted in response to managed care strategies used by health insurers or other health coverage providers. in both cases, the court resolved the preemption issue through analysis involving only erisa's savings clause.33 this part of the article first explains the state laws challenged in the cases and then provides a general sketch of the basic principles of erisa' s preemption and savings clause doctrines. a. the rush case the state law at issue in rush was a provision in the illinois health maintenance organization act ("the hmo act") requiring hmos to provide independent and external review ("ier") of the question whether a covered service is medically necessary when a dispute arises between the primary care further, the claims arise, at least in part, from a denial of benefits. thus, according to many lower courts, such claims fall within the scope of § 502(a)(l)(b), which provides a cause of action to plan participants and beneficiaries to recover benefits due. however, the claims also are not so clearly within the scope of the federal statute as in taylor and beneficial national bank. claimants such as davila and calad are seeking compensatory damages as a remedy for harm caused by a negligent decision, recommending that services or treatments are not medically necessary; they are not seeking benefits due under the plan, however, they are challenging medical decisions and not merely a denial of coverage. moreover, the state cause of action protects a right that is not protected by erisa. a § 502(a)(l)(b) action protects primarily a contractual right to benefits promised under the plan; whereas, the state claim protects the right to have a medical necessity decision made in accord with a standard of reasonable care. the issue, then, is whether a claim by plan participants, such as calad and davila, against hmos which administer their benefits should be characterized as "within the scope of § 502(a)(l)(b)" whenever the factual allegations involve a denial of coverage and the claim arises from that denial of coverage, even though the state law claim is regulating conduct that erisa does not regulate (the exercise of medical discretion) and is protecting rights not addressed by erisa. in the author's view, the supreme court complete preemption cases suggest that the proper inquiry does not focus on the factual circumstances giving rise to the claim. the inquiry, rather, focuses on the claim asserted: whether the purported state claim duplicates a cause of action explicitly authorized by the federal statute by regulating conduct that is regulated by the federal statute and protecting a right protected by the federal statute. additionally, the focus in the supreme court cases was not on the remedy sought; although, an obvious consequence of asserting a claim within the scope of a federal cause of action is that the plaintiff is thereby limited to the remedies allowed by the federal statute. under this view, the state claims in davila are not within the scope of the complete preemption doctrine. 33. through erisa's savings clause, congress expressly exempted from the reach of erisa preemption state laws that regulate insurance. erisa' s savings clause prescribes that erisa shall not "be construed to exempt or relieve any person from any law of any state which regulates insurance .... " 29 u.s.c. § 1144(b)(2)(a). the supreme court traditionally has declared that erisa's savings clause should be broadly construed, but in reality has kept the scope of the exemption relatively narrow. 2004] recent modifications to the preemption docrrine 61 provider of a plan subscriber and the hmo and to cover services deemed medically necessary by the independent reviewer. 34 the plaintiff, debra moran, was a beneficiary of an erisa health benefit plan. moran's erisa plan contracted with rush prudential hmo, inc. ("rush hmo"), to provide medical services for plan participants and beneficiaries. 35 moran's primary care physician recommended that rush hmo approve of a particular treatment for moran's condition; however, rush hmo denied the request on the ground that the procedure was not medically necessary, and moran invoked the ier provision. 36 after being compelled by a state court, rush hmo submitted moran's claim for ier. the independent reviewer decided that the recommended treatment was medically necessary, but rush hmo continued to deny moran's claim.37 moran, who had proceeded with her treatment pending the process, sought reimbursement for the cost of the treatment by filing a civil action in state court. rush hmo removed moran's claim to federal court, under the lllinois ier provision, and the district court properly treated the claim as a suit under erisa for benefits due. 38 the district court denied the claim on the ground that erisa preempted the lllinois ier law; no other basis for the claim for benefits was at issue.39 the seventh circuit reversed.40 a majority of the supreme court affirmed the seventh circuit's decision and held that erisa did not preempt the ier law.41 the court first summarily concluded that it was "beyond serious dispute" that the law relates 34. see rush prudential hmo, inc. v. moran, 536 u.s. 355, 359-61 (2002). the ier law provides: each health maintenance organization shall provide a mechanism for the timely review by a physician holding the same class of license as the primary care physician, who is unaffiliated with the health maintenance organization, jointly selected by the patient ... , primary care physician and the health maintenance organization in the event of a dispute between the primary care physician and the health maintenance organization regarding the medical necessity of a covered service proposed by a primary care physician. in the event that the reviewing physician determines the covered service to be medically necessary, the health maintenance organization shall provide the covered service. see lllinois hmo act, 215 ill. comp. stat. 125/4-10 (2000). the act defines a health maintenance organization as "any organization formed under the laws of this or another state to provide or arrange for one or more health care plans under a system which causes any part of the risk of health care delivery to be borne by the organization or its providers." id. 125/1-2. 35. rush, 536 u.s. at 359. 36. moran's primary care physician ''recommended that rush approve surgery by an unaffiliated specialist ... who had developed an unconventional treatment for moran's condition." id. at 360. 37. id. at 361-62. 38. id. at 362. 39. id. at 363. 40. jd. 41. rush, 536 u.s. at 387 ('"the savings clause is entitled to prevail here, and we affinn the judgment."). 62 indiana health law review [vol. 1:51 to employee benefit plans.42 the court noted that the law "bears 'indirectly but substantially on all insured benefit plans' ... by requiring them to submit to an extra layer of review for certain benefit denials if .they purchase medical coverage from any of the common types of [hmos] covered by the state law's definition of hm0."43 the court thus viewed the preemption analysis as hinging on the erisa savings clause analysis. b. the karp case two any-willing-provider laws ("a wp statutes") were at issue in kahp, one regulating benefit plan relationships with health care providers generally44 and one regulating their relationships with chiropractic providers.45 both statutory provisions prohibited discrimination by health care benefit plans against health care providers willing to meet the terms and conditions and other standards established by the plans for participation in the plans.46 the laws thus interfered with the managed care strategy of contracting with networks of selected health care providers in order to control costs and quality. the court noted that, pursuant to a contract between the hmo and providers, the providers "agree[ d] to render health-care services to the hmos' subscribers at discounted rates and to comply with other ... requirements. in return, they receive the benefit of patient volume higher than that achieved by 42. id. at 365. 43. /d. (quoting metro. life ins. co. v. massachusetts, 471 u.s. 724,739 (1985)). while the relation to erisa plans was fairly obvious, the opinion would have been clearer if the court had explained the law's impermissible connection with erisa plans. the law acts directly on hmos. many of the regulated hmos contract with erisa plans. accordingly, the require­ ment of ier adds a step in the process of claims administration for those erisa plans that contract with hmos. the process of administering claims for benefits for erisa plan partici­ pants and beneficiaries is at the heart of administration of an erisa benefit plan. accordingly, the ier law can readily be characterized as a law that mandates or binds administration of the erisa benefit plans and therefore constitutes an impermissible connection with erisa plans. as explained more fully infra, for precisely this reason, however, many students of the erisa preemption doctrine believed that the court would fmd the law preempted, notwithstanding the savings clause analysis. the dissenting justices also noted this point. ld. at 387-89. 44. ky. r.ev. stat. ann. § 304.17a-110(3) (banks•baldwin 1994) (repealed 1999) ("health care benefit plans shall not discriminate against any provider who is located within the geographic coverage area of the health benefit plan and is willing to meet the terms and conditions for participation established by the health benefit plan."} (emphasis added). see /d. § 304.17a-l00(4)(a). health benefit plan is defined to mean any "hospital or medical expense policy or certificate; non-profit hospital, medical-surgical, and health service corporation contract or certificate; a self-insured plan or a plan provided by a multiple employer welfare arrangement, to the extent permitted by erisa; health maintenance organization contract; and [certain) standard and supplemental health benefit plan(s)." /d. 45. /d. § 304.17 a-171 (2) ("[a) health care benefit plan that includes chiropractic benefits shall . . . [p )ermit any licensed chiropractor who agrees to abide. by the tenns, conditions, reimbursement rates, and standards of quality of the health benefit plan to serve as a participating primary chiropractic provider to any person covered by the plan.") (emphasis added). 46. see supra notes 44-45 and accompanying text. 2004] recent modifications to nib preemption doctrine 63 nonnetwork providers who lack aecess to [the hmos'] subsaibers.'t47 hmos are often opposed to awp statutes because they interfere with an hmo's ability to limit the nuniber of providers in a network and thus impair the "ability to use the assurance of high patient volume as the quid pro quo for discounted rates;" thereby frustratifig an hmo's cost and quality control.48 accordingly, hmos licensed under the laws of kentucky and a kentucky-based association of limos sought an injunction against enforce­ ment of the a wp statutes, arguing that they were preempted by erisa.49 the district court and sixth chtuit court of appeals concluded that the laws relate to erisa plans within the meaning of erisa's preemption clause, but the laws were saved from p~mption because they regulate insurance. 50 the supreme court addressed only whether the a wp statutes constitute laws that regulate insurance. c. the preemption issues in both rush and kahp, the state laws at issue were challenged as being preempted by erisa. preemption of state laws by erisa involves considera­ tion of both § 514 of erisa, the basic preemption clause, and § 514(b )(2)(a), erisns savings clause. section 514(a) of erisa provides that erisa "supersede[s] any and all state laws insofar as they may now or hereafter relate to any employee benefit plan ..• .''51 the supreme court has always explained that erisa's preemption provision reflects broad congressional intent to preempt state laws that have a connection with or reference to erisa plans.'2 however, in more recent years, the court has also more clearly refined limitations on the broad scope of erisa preemption. the court has determined that the analysis should be guided by the objectives of erisa and should involve consideration of the nature and purpose, as well as the effect, of the state law at issue. 53 rather than any mere refetence to an erisa plan, the court has stated that a reference will warrant preemption if the state law "acts immediately or exclusively upon erisa plans, • . • or where the 47. ky. ass'n of health plans, inc. v. miller, 123 s. ct. 1471,.1474 (2003). 48./d. 49. ky. ass'n of healtlt plans, inc. v. niemi$, 227 f.3d 352, 355 (6th cir. 2000). so; jd, at 355,357-63 (p~ott analysis), 363-72 (savings dause analysis). 51. 29 u.s.c. § 1144(ll)(2003). 52. see, e.g.; shaw v. delta air lines, inc., 463. u.s. 85 (1983) (related to :arisa plans because a mandated benefit requirtment bears indirectly but silbstantialiy on all insured plans); mackey v. lanier collection agency & setv., inc., 486 u.s. 825 (1988) (preempted because the statute refereneed elusa plans llnd was specifically designtd to llffect such plans); fmc corp. v. holliday, 498 u.s. 52 (1990) (anti·subrogation law contained a reference to benefit plans and had a connection with such plans because it posed the risk of ~bjecting plan administrators to conflicting state regulations). . 53. n.y. state coilfetc;nee of blue cross & blue shield plans v. travelers ins. co., 514 u.s. 645, 655·51 {1995). . 64 indiana health law review [vol. 1:51 existence of erisa plans is essential to the law's operation .... "54 rather than any mere connection with an erisa plan, the court has stated that preemption is warranted if the law .. mandates employee benefit structures or their administration or provides alternative enforcement mechanisms [to erisa]."55 further, the court has emphasized the presumption against preemption of state laws regulating the health and welfare of a state's citizens, an area traditionally within a state's police powers. 56 through erisa's savings clause, congress expressly exempted state laws that regulate insurance from the reach of erisa preemption. erisa's savings clause prescribes that erisa shall not "be construed to exempt or relieve any person from any law of any state which regulates insurance .... "57 the supreme court traditionally has declared that erisa' s savings clause should be broadly construed, but in reality has kept the scope of the exemption relatively narrow. before kahp, the scope of the clause was circumscribed by grafting into the analysis the complex tripartite standard originally established under the mccarran-ferguson act for determining whether a practice constitutes the .. business of insurance" for purposes of that act's antitrust exemption. 58 the savings clause analysis therefore included the following basic legal standards: (1) whether the law regulates insurance from a common sense perspective; and (2) whether the law satisfies the mccarran­ ferguson factors-namely, does it target a practice that (a) has the effect of transferring or spreading a policyholder's risk, (b) is an integral part of the policy relationship between the insurer and the insured, and (c) is limited to entities within the insurance industry.59 in addition, the court has further narrowed the scope oferisa's savings clause by injecting into the analysis a moderating factor or exception to saving a law regulating insurance; the conflict preemption exception allows consideration of whether saving the state law would further the objectives of erisa. for example, in pilot life insurance co. v. dedeaux, the court bolstered its decision that a state law was not saved by explaining that preemption was warranted in order to avoid frustration of congressional objectives underlying erisa's complex civil enforcement provisions. 60 54. cal. div. of labor standards enforcement v. dillingham constr. n.a., 519 u.s. 316, 325 (1997) (citing makey v. lanier collection agency & serv., inc., 486 u.s. 825 (1988); district of columbia v. greater wash. bd. of trade, 506 u.s. 125 (1992)). 55. travelers, 514 u.s. at 658. 56./d. 57. 29 u.s.c. § 1144(b )(2)(a) (2003). 58. see, e.g.,metropolitanlifelns.co. v.massachusetts,471 u.s. 724, 743(1985). the factors developed in the mccarran-ferguson act cases require an assessment of whether the law targets a practice that has the effect of transferring or spreading a policyholder's risk, is an integral part of the policy relationship between the insurer and the insured, and is limited to entities within the insurance industry. see id. 59./d. 60. pilot life ins. co. v. dedeaux, 481 u.s. 41, 52-57 (1987). this article will refer to the consideration of conflict preemption principles as the conflict preemption exception. 2004] recent modifications to 1he preemption doctrine 65 the supreme court in rush and karp addressed only whether the laws at issue were saved from preemption. because neither case explained in any detail why the laws had a sufficient connection with erisa plans to warrant preemption and thus trigger the savings clause, the cases add little to our understanding of the application of erisa's preemption clause. as noted, however, the cases significantly add to our understanding of the application of the savings clause. karp streamlined the basic legal standards of the savings clause analysis and rush limited the scope of the conflict preemption exception; both cases reflect a broader view of laws saved from erisa preemption. the following part of the article details the doctrinal modifica­ tions of the saving clause analysis and the key policy implications thereof. ill. the r.efinements to the basic savings clause analysis prior to karp, the basic savings clause standards included the common sense test and a consideration of the mccarran-ferguson act factors. these basic standards had been applied in countless lower court cases over the years. as noted, the standards have generally been applied in a fairly narrow manner, especially the mccarran-ferguson factors. as explained in more detail later in the article, the mccarran-ferguson factors were developed in cases involving the mccarran-ferguson act's antitrust exemption for the "business of insurance."61 in those cases, the supreme court appropriately took a narrow view of what constitutes the business of insurance. lower courts have tended to follow this narrow approach in the erisa context.62 additionally, over the years, the savings clause inquiry had become somewhat truncated. in addressing whether a state law satisfies the common sense test, the supreme court has traditionally asked whether the law is "specifically directed" towards the insurance industry. for example, in pilot life, 63 the court found that a common law cause of action arising from the insurer's allegedly bad faith refusal to pay a claim for benefits did not further a "common sense" understanding of erisa' s saving clause because the action evolved from general principles of tort and contract law which, obviously, were not applicable solely to insurers.64 in recent years, however, lower courts have also asked, in the common sense prong of the analysis, whether the law focuses on the primary elements of insurance-the spreading and underwriting of a policyholder's risk-or whether the law deals with the relationship 61. see infra notes 98-105 and accompanying text 62. see, e.g., franklin h. williams ins. trust v. travelers ins. co., so f.3d 144 (2d cir. 1995); smith v. jefferson pilot life ins. co., 14 f.3d 562 (11th cir. 1994); tingle v. pacific mut. ins. co., 996f.2d 105 (5th cir.l993); mcmahan v.newenglandmut.lifeins. co., 888 f.2d426 (6th cir. 1989). see generally karen a. jordan, erisa pre-emption: integrating fabe into the savings clause analysis, 21 rutgers w. 273 (1996). 63. pilot life ins. co. v. dedeaux, 481 u.s. 41 (1987). 64. id. at 50 ("any breach of contract, and not merely breach of an insurance contract, may lead to liability for punitive damages under mississippi law."). 66 indiana heal-th law ravibw [vol. 1:51 between the insurer and insured. in doing so, th~ courts have thereby tended to truncate the analysis by blending the common sense and mccarren­ ferguson act factor considerations. courts have also tende9 to truncate the analysis by stating that an affmnative answer to the questioq whether a law is specifically directed towards the insuran<;e industry also shows that the law satisfies the third mccarran-ferguson factor; that is, if the law is specifically directed towards the insurpnce industry, the law also is limited to entities within the insurance industry. the sixth circuit's opinion iq the karp case provide$ a good e1t.ample of the truncated analysis. 65 in addressing the coj.llll\on sense prong of the test, the sixth circuit fqund ~t the a wp laws tqet insurance ~ause the laws regulate entities such as insurers and hmos which engage in the spreading and underwriting of policyholders' risk. and }jecause the laws deal directly with the relationship between insureds and insurers.66 both of these considerations are part of the mccarran·ferguson act analysis. in~. when engaging in the mccarran-ferg~on act analysis, the sixth circuit repeated its view that the laws affect ris~ 8preading (since the type of coverage is a component of risk) and regul~te the relationship between the insurep ~insurer; the court further noted that the third mccarran~fergu&on factor w~ satisfied for the reasons previously stated in the common sense part of the analysis. 67 ·the savings clause analysis has also been somewhat relaxed in recent years in light of the supreme court's clarification in· unum life insurance v. wartfb that the. mccarran~ferguson act factors serve as guideposts or checking points and do not constitute separate essential requirqments. 69 before unum, some lower courts rigidly required an affmnative answer to all three of the mcc~n .. ferguson act factors before finding a law saved from preemption. 70 · the court in unum explained that the factors were '"considerations [to be] weighed'"71 ''and that '[n]one of these criteria is necessarily determinative in itself. "'72 nonetheless, the court in unum, and later in rush, continued to address the three mccarran-ferguson act factors as part of the basic ~aving$ clause analysis. 73 65. see ky. ass'n of health plans, inc. v. nichols, 227 f.3d 352 (6th cir. 2000). 66. /d. at 364-68. 67. ld. at 368~ n. 68. unum life ins. v. ward, 526 u.s. 358 (1999). 69. id. at373,74. 70. see, e.g., tingle v. pacific mut. ins. co., 996 f.2d 1 os, 110 (5th cir. 1993)( deciding that because the state law did •<p9t spre811 the [policy})older's] risk," it was unnecessary to address the other factors set forth in metropolitan f;je). s~ also coots v. united employers fed'n, 865 f. supp. 596 (e.i). mo.1994) (following tingle). 71. unum, sui u.s. ~t 373 (quoting pilot life ins. co. v. dedea~. 481 u.s. 41, 49 (1987)). 72, /d. (q\loting union labof life in11. co. v. ~no, 4s8 u.s. 119, 129 (l982)). 73, see infra notes 83-85 a:qd accompanying text. 2004] recent modifications to the preemption doctrine 67 the court in rush had little difficulty applying the basic legal standards of the savings clause analysis; yet, the decision significantly aids in under­ standing the court's application of the standards to state laws regulating hmos. the court's decision in karp is similarly important, as it streamlined the basic standards by rephrasing the three mccarran-ferguson factors as one factor. moreover, both decisions reflect a broader view of laws saved from preemption. a. rush: broadening the "who" and the "what" of laws saved the court in rush had little difficulty applying the basic standards to the ier provision to determine whether the provision was saved from preemption. two important principles nonetheless emerged, both relevant to the .common sense prong of the savings clause analysis. first, in first applying the common sense inquiry, the court in rush focused on who the law regulates and resoundingly rejected rush hmo' s argument that because the law regulates hmos, it does not regulate insurance. 74 the court noted that the common sense inquiry focuses on "'primary elements of an insurance contract [which] are the spreading and underwriting of a policyholder's risk.' "75 the court then readily found that an hmo, although in part a health care provider, also provides insurance: "[i]t would ignore the whole purpose of the hmo-style of organization to conceive of hmos ... without their insurance element."76 the court exhaustively recounted authority for the proposition that hmos assume fmancial risk and underwrite and spread risk among their participants. 77 indeed, the court noted that "virtually all commentators on the american health care system describe hmos as a combination of insurer and provider, and observe that in recent years, traditional 'indemnity' insurance has fallen out of favor."78 according 74. rush prudential hmo, inc. v. moran, 536 u.s. 355,359-61 (2002). the court noted, "rush contends that seeing an hmo as an insurer distorts the nature of an hmo, which is, after all, a health care provider, too. this, rush argues, should detennine its characterization, with the consequence that regulation of an hmo is not insurance regulation within the meaning of erisa." /d. 75. /d. (quoting group life & health ins. co. v. royal drug co., 440 u.s. 205, 211 (1979)). 76. ld. at 367. 77. !d. at 367"68. the court cited pegram v. herdrich, 530 u.s. 211, 218-19 (2000), "the hmo thus assumes the financial risk of providing the benefits promised .... " /d. congressional understanding when the hmo act of 1973 was enacted included requirements that the limos would bear and manage risk. /d. at 233-34. congress was aware that states regulated limos as insurers and compared limos to indemnity or service benefits insurance plans; and the continued regulation of limos by states through their respective insurance departments. rush, 536 u.s. at 368-69. see also richard posner, economic analysis of law 104 (4th ed. 1992). limos underwrite and spread risk among their participants. /d. 78. rush, 536 u.s. at 370 (citing weiner & de lissovoy, razing a tower of babel: a taxonomy for manqged care and health insurance plans, 18 j. health pol., pol'y &l. 75, 77 (1993)); marsha r. gold, understanding the roots: health maintenance organizations in 68 indiana health law review [vol. 1:51 to the court, "nothing in the saving clause requires an either-or choice between health care and insurance in deciding a preemption question, and as long as providing insurance fairly accounts for the application of state law, the savings clause may apply."79 second, the court also rejected rush hmo's argument that the dlinois ier provision was drafted too broadly to constitute a law specifically directed at the insurance industry. rush hmo argued that the law's definition of hm080 would result in application to an entity that contracted with a self­ funded erisa plan to provide only administrative services and, which in fact, did not assume any fmancial risk. 81 the court held that congress likely did not intend that such minimal application to noninsurers would preclude a law from being characterized as insurance regulation saved from preemption. 82 thus, rush reflects a broader application of the common sense prong of the savings clause analysis than in earlier cases. the court also easily disposed of the mccarran-ferguson prong of the analysis. the court in rush readily found that the second and third mccarran­ ferguson factors were satisfied, expressly avoiding the need to answer whether the mr law regulates a practice that "spread[s] a policyholder's risk."83 lllu­ strating the truncated nature of the analysis. the court found that the law is aimed at a practice limited to entities within the insurance industry for virtually the same reasons that the law pas~ the common sense test: hmo contracts are contracts for insurance. 84 additionally, the court concluded that the law is integral to the policy relationship between the insured and the insurer. the court held that the extra layer of review of a claims dispute created by the law affects the policy relationship between the hmo and covered person "by translating the relation­ ship under the hmo agreement into concrete terms of specific obligation or freedom from duty."8' the court thus viewed the law, in essence, as targeting historical context, in contemporary managed care 7, 8, 13 (m. gold ed., 1998); aspen healtiilaw &compuancectr.,managedcarelawmanual 1 (supp. 6, nov.1997); r. rosenblati et al., law and tile a.melucan healtii care system 552 (1997); r. shouldice,introductiontomanagedcare 13,20 (1991)). 79. rush, 536 u.s. at 367. 80. the dlinois act, chapter 125 sections 1 and 2, defines an hmo as "any organization formed under the laws of this or another state to provide or arrange for one or more health care plans under a system which causes any part of the risk of health care delivery to be borne by the organization or its providers." ld. at 370-71. 81. ld. rush argued that the law would apply to an hmo that merely brought together self-funded erisa plans and medical care providers, even if the providers bore all the risk. ld. 82. ld. at 372. 83. ld. at 373 (quoting unum life ins. v. ward, 526 u.s. 358, 373 (1999)). foregoing analysis of the first mccarran-ferguson factor because the second and third factors were clearly satisfied by the ier law. rush, 536 u.s. at 373. 84. ld. at 374. 85. ld. at 373. the court noted that the law provides "a legal right to the insured, enforceable against the hmo, to obtain an authoritative determination of the hmo's medical obligations." ld. at 374. 2004] recent modifications to the preemption docirine 69 the interpretation of the insurance agreement between the hmo and covered persons when applied to the question whether a submitted claim is medically necessary. the analysis of the mccarran-ferguson factors in rush also arguably reflects a broader view of the savings clause. in an analogous earlier case, union labor life insurance co. v. pireno,86 the supreme court held that the use of peer review by an insurer as a check on medical necessity determina­ tions was not integral to the policy relationship between the insured and the insurer. the particular type of review at issue in the prior case was distin­ guishable primarily because it was advisory; whereas in rush, the ier law specified that the finding of the independent external reviewer is binding. 87 this difference is significant however, the court in rush noted, "it was not too much of an exaggeration to conclude [in pireno] that the practice was 'a matter of indifference to the policyholder."'88 the court in rush thus acknowledged that its conclusion in pireno was borderline; thereby suggesting that, at least in the erisa context, the practice likely would satisfy the mccarran-ferguson factors. as noted, this reflects a broader application of the savings clause. however, as the next section of the article explains, the kahp decision goes much further in modifying the mccarran-ferguson prong of the savings clause analysis, and thereby in broadening the scope of laws exempt from preemption under erisa' s savings clause. b. kahp: streamlining the analysis kahp similarly represents important refinements to the basic savings clause standards. first, the court's application reflects a broader view of laws saved from preemption. second, the court recognized the truncated nature of the analysis and streamlined it. the court concluded that for a state law to be deemed a law which regulates insurance, the law must satisfy only two requirements; the law "must be specifically directed toward entities engaged in insurance" and "must substantially affect the risk pooling arrangement between the insurer and the insured.'t89 the streamlining was thus twofold. first, the court dropped the common sense language and focused instead on its judicial gloss-whether a state law is specifically directed at the insurance industry. second, the court made a "clean break from the mccarran-ferguson factors."90 the break from the mccarran-ferguson factors was surprising in the sense that the court in rush did not expressly suggest an eminent shift and, in fact, applied the factors to the ier law. however, justice scalia, in kahp, highlighted the following 86. union labor life ins. co. v. pireno, 458 u.s. 119 (1982). 87. see supra note 34 and accompanying text. 88. rush, 536 u.s. at 374. 89. ky. ass'n of health plans, inc. v. miller, 123 s. ct 1471, 1479 (2003). 90.id. 70 indiana health law review [vol. 1:51 language from rush which impliedly foreshadowed the break. in its initial explanation of the savings clause analysis, the court in rush noted that it is "generally fair to think of the combined 'common-sense' and mccarran­ ferguson factors as parsing the 'who' and the 'what:' when insurers are regulated with respect to their insurance practices, the state law survives erisa."91 arguably, this statement suggests that, in reality, there are but two key considerations in addressing whether a law is saved from preemption. little consequence is likely to result from the first refinement. as noted, the supreme court had historically explained that the common sense test is satisfied when a state law is specifically directed at the insurance industry. thus, presumably, the existing case law benchmarks for when that test is satisfied, including the relaxing of the test in rush, remain good benchmarks. the court in kahp followed the analysis in rush and similarly focused on who the law regulates; thus, the court ultimately rejected the hmos' con­ tention that kentucky's a wp laws failed the test because the laws regulate "not only the insurance industry, but also doctors who seek to form and main­ tain limited provider networks with hmos."92 the court· noted that neither statute "by its terms" imposes prohibitions or requirements on providers; but, rather, the statutes impose them on "health insurer[s]" and ''health benefit plans."93 the court noted that the unavoidable effect on providers-the inability to enter into certain agreements with kentucky insurers-was insuffi­ cient to preclude characterizing the law as one specifically directed towards the insurance industry.94 the kahp court also rejected the hmos' arguments that the a wp statutes failed the specifically directed test because the laws applied to self­ insured erisa plans and hmos that provided only administrative services to self-insured plans. according to the court, the entities, in both situations, sufficiently engage in the activity of insurance such that the laws are still appropriately directed at the insurance industry.95 the court also expressly affirmed the view espoused in rush that congress likely did not intend for "minimal application to noninsurers to remove a state law entirely from the category of insurance regulation saved. "96 thus, kahp affirmed the broader 91. rush, 536 u.s. at 366; ky. ass'n of health plans, 123 s. ct. at 1475. in karp, justice scalia stated: "as we explained in rush prudential, insurers must be regulated 'with respectto their insurance practices."' ky. ass'n of health plans, 123 s. ct. at 1475. 92. /d. 93. /d. 94. !d. at 1475-76 ("regulations 'directed toward' certain entities will almost always disable other entities from doing, with the regulated entities, what the regulations forbid; this does not suffice to place such regulation outside the scope oferisa's savings clause."). 95. /d. at 1476 n.l ("self-insured plans engage in the same sort of risk pooling arrange­ ments as separate entities that provide insurance;" and that "administering self-insured plans ... suffices to bring ... [hmos] within the activity of insurance for purposes of [the savings clause]."). 96./d. 2004] recent modifications to the preemption doctrine 71 view that "some over breadth" in state laws regulating insurers will not interfere with application of the savings clause. the second refinement, the "clean break from the mccarran-ferguson factors," may have greater consequences. the supreme court has historically explained that state laws saved from erisa preemption are those that not only are specifically directed at the insurance industry, but that also regulate insurers as to the business of insurance. for example, the court in rush explained that a law regulates insurance within the scope of erisa' s savings clause when the law regulates the insurance industry "with respect to their insurance practices."97 the supreme court originally looked to the mccarran-ferguson factors as a way to help assess whether a law regulates insurers with respect to their insurance practices. in metropolitan life insurance co. v. massachusetts,98 the court first referred, in the erisa savings clause analysis, to two mccarran-ferguson act cases, group ufe & health insurance co. v. royal drug99 and union labor life insurance co. v. pireno.100 the court looked to the factors used in those cases because they had been developed for a similar purpose: to identify whether certain activities of insurers constitute the business of insurance. the mccarran-ferguson cases involved the antitrust exemption from the mccarran-ferguson directive preserving to states, generally, primary authority over the regulation of insurers and the business of insurance. 101 the mccarran-ferguson act also allows federal regulation of insurance if the federal law specifically relates to the business of insurance and allows application of the federal antitrust laws to insurers.102 however, the act creates an exception to application of the federal antitrust laws: the antitrust laws will not apply to a practice that constitutes the business of insurance if the 97. ky. ass'n of health plans, 123 s. ct. at 1475 (quoting rush prudential hmo, inc. v. moran, 536 u.s, 355, 366 (2002)). 98. metro. life ins. co. v. massachusetts, 471 u.s. 724, 743 (1985). 99. group life & health ins. co. v. royal drug, 440 u.s. 205 (1979). 100. union labor ufe ins. co. v. pireno, 458 u.s. 119 (1982). 101. 15u.s.c. §§ 1011-1015(2003). themccarran-fergusonact,section2(b),provides: "no act of congress shall be construed to invalidate, impair, or supersede any law enacted by any state for the purpose of regulating the business of insurance •... " see id. § 1 012(b ). see also united states v. south-eastern underwriters ass'n, 322 u.s. 533 (1944). the mccarran­ ferguson act was enacted in response to the supreme court's holding in united states v. south­ eastern underwriters ass'n that an insurance company conducting a substantial part of its busi­ ness across state lines was engaged in interstate commerce and thereby subject to the antitrust laws. fearing commerce clause challenges, congress enacted, within two years of the south­ eastern underwriters ass 'n decision, the mccarran-ferguson act and restored to the states the ability to continue taxing and regulating the insurance industry without fear of commerce clause challenges. see rand e. rosenbiati' et al., law and the american health care system 143 (1997). 102. 15u.s.c. § 1012(b). theactprovidesthatfederallawshallnotsupersedestatelaws regulating insurance ''unless such [federal] act specifically relates to the business of insurance: provided, that ... [the federal antitrust laws] shall be applicable to the business of insur­ ance .... " ld. (emphasis added). 72 indiana heal til law review (vol. 1:51 state regulates that practice.103 because royal drug.and pireno involved anti­ trust challenges to certain insurance practices and the mccarran-ferguson factors were thus developed in the context of an exemption to the antitrust laws, the case law suggested a narrow view of what constitutes the business of insurance. some scholars, however, have noted an incongruity.104 using the narrow approach to the business of insurance, developed in royal drug and pireno, is inconsistent with the broad intent of congress to save state laws that regulate insurance from erisa preemption.105 nonetheless, the supreme court continued to use the mccarran-ferguson factors although it had not expressly explored, in its erisa preemption opinions, the appropriateness of applying the factors in light of the broad scope of erisa preemption. accordingly, in kahp, the hmos relied on royal drug in arguing that the a wp statutes were not saved from preemption. 106 in royal drug, independent pharmacies mounted an antitrust challenge against blue shield's practice of entering into preferred provider ~ments with certain phar­ macies, which tended to result in policyholders using the preferred pharmacies rather than nonparticipating pharmacies.107 the case thus provided a seem­ ingly perfect analogy for analyzing the a wp statutes. in royal drug. the issue was whether the practice by ail insurer of contracting with some but not all providers constituted the business of insurance. in kahp, the issue was whether a state law regulating or prohibiting the practice of contracting with some but not all providers constituted a law regul~tting the insurance industry as to insurance practices. because royal drug involved an antitrust challenge and did not involve erisa preemption, the court focused predominantly on the mccarran­ ferguson factors to detennine whether the preferred contracting arrangement constituted the business of insurance.. the court in royal drug noted that underwriting and the spreading of risk of loss as widely as possible were indispensable characteristics of insurance.108 the court held that the practice of contracting with pharmacies did not involve either characteristic; rather, the practice was merely a cost-savings strategy and "indistinguishable from countless other business arrangements that may be made by insurance companies to keep their costs low."109 this reasoning was sound because the 103. id. more specifically, the act provides that the federal antitrust laws "shall be applicable to the business of insurance to the extent that such business is not regulated by state . law." /d. 104. see, e.g., jordan, supra note 62, at 273. 105. see, e.g., shaw v. delta air lines. inc., 463 u.s. 85 (1983). in shaw, the court noted, "the breadth of§ 514(a)'"s pre-emptive reach is apparent from that section's language. a law 'relates to' an employee benefit.plan, in the normal sense of the phrase, if it has a connection with or reference to such a plan." /d. at 96-97 (citing black's law dictionary). 106. ky. ass'n of health plans. inc. v. miller, 123 s. ct 1471, 1476-77 (2003). 107. group life & health ins. co. v. royal drug co., 440 u.s. 205 (1979). 108. /d. at 212 (citing sec v. variable annuity life ins. co., 359 u.s. 65, 79 (1959)). 109. /d. at 213-15. 2004] recent modifications to the preemption doctrine 73 pharmacies did not assume any risk under the particular provider agreement at issue. participating phannacies agreed to charge blue shield policyholders two dollars per prescription and to accept discounted reimbursement from blue shield in an amount that would cover the cost to pwirmacies of acquiring the drug.t'0 the arrangement encouraged policyholders to go to preferred phar­ macies and thereby lowered blue shield's cost in prescription drug coverage. additionally, the court in royal drug found that the preferred con­ tracting arrangement did not affect the contract between the insurer and the insured. the court noted that, in preserving insurance regulation for the states and in limiting application of the federill antitrust laws to the business of insurance, congress' concern was with '"[t]he relationship between insurer and insured, the type of policy which could be issued, its reliability, interpre­ tation, and enforcement. ... m the court concluded that, because the agree­ ments were merely cost-saving arrangements, they did not affect the reliability, interpretation, or enforcement of the insurance contract.112 further, the court concluded that "[t]here is not the slightest suggestion in the legislative history that congress in any way contemplated that arrangements ... which involve the mass purchase of goods and services from entities outside the insurance industry, are the 'business ofinsurance."'113 by analogy, then, kahp certainly had a meritorious argument that a state law regulating the practice by insurers of entering into preferred provider agreements is not a state law regulating insurers as to an insurance practice. nonetheless, justice scalia and the court concluded, "it does not follow from royal drug that a law mandating certain insurer-provider relationships fails to 'regulate insurance. ,.,114 the court then reached a conclusion inconsistent with royal drug by holding that the kentucky a wp statutes were saved from erisa preemption. the court accomplished this outcome by taking a broader approach to the issue and by making "the clean break" from the mccarran­ ferguson factors. the court in kahp distinguished royal drug by noting that ''erisa' s savings clause ... is not concerned (as is the mccarran-ferguson act provision) with how to characterize conduct undertaken by private actors, but with how to characterize state laws in regard to what they 'regulate. '"115 then, to help illustrate what type of state law could legitimately be characterized as "'regulating insurance," the court described a state law requiring licensed attorneys to participate in ten hours of continuing legal education ("cle") each year, noting that "(t]his statute 'regulates' the practice of law-even though sitting through [ten] 10 hours of cle classes does not constitute the 110. id. 111. id. at 215-16 (citing variable anp~uity life ins. co., 359 u.s. at 65). 112. id. at 216-17. 113. see group life, 440 u.s. at 224. 114. ky. ass'n of health plans, inc. v. millei,l23 s. ct. 1471, 1477 (2003). 115. /d. at 1476-77. 74 indiana health law revjew [vol. 1:51 practice of law-because the state has conditioned the right to practice law on certain requirements, which substantially affect the product delivered by lawyers to their clients."116 according to the court, kentucky's a wp statutes similarly impose conditions on the right to engage in insurance: "those who wish to provide health insurance in kentucky ... may not discriminate against any willing provider.''117 the court's new approach, however, is not quite as broad as the fore­ going statement implies. justice scalia explained that to remain true to the idea that a law is saved only if it regulates the insurance industry with respect to insurance practices, a law conditioning the right to engage in the business of insurance must "substantially affect the risk pooling arrangement between the insurer and the insured."118 the court found that kentucky's a wp laws satisfied that requirement: by expanding the number of providers from whom an insured may receive health services, a wp laws alter the scope of per­ missible bargains between insurers and insureds . . . . no longer may kentucky insureds seek insurance from a closed network ... in exchange for a lower premium. the a wp prohibition substantially affects the type of risk pooling arrangements that insurers may offer.119 thus, under kahp, a state law can constitute a state law regulating insurance within erisa's savings clause regardless of whether the practice or conduct regulated constitutes the business of insurance, as long as the law has the requisite substantial affect on the risk pooling arrangement between the insurer and the insured. although the new perimeters of the savings clause in light of justice scalia's new terminology is uncertain, it is clear that the court has broadened the scope of the laws exempt from preemption due to the savings clause. if a state law is saved when it affects the product offered to subscribers by an hmo (the health coverage policy), then many recent managed care reform laws passed by states will satisfy the standard. 120 moreover, the court in kahp ensured a broader approach to the savings clause analysis in future cases by making the "clean break" from the mccarran-ferguson factors. the court noted, "we believe that our use of the mccarran-ferguson case law in the erisa context has misdirected attention, failed to provide clear guidance to lower federal courts, and, as this case 116. /d. at 1477. 117. id. 118. id. 119. id. at 1477-78. 120. see infra notes 137-38 and accompanying text. 2004] recent modifications to the preemption doctrine 75 demonstrates, added little to the relevant analysis."121 the court then explained that it had never held that the mccarran-ferguson factors were an essential component of the savings clause analysis, that the court had referred to them as mere "considerations [to be] weighed," and that they were only "'checking points' [or guideposts] to be used after determining whether the state law regulates insurance from a 'common-sense' understanding."122 accordingly, the court proclaimed to make a clean break and repeated that a state law need satisfy only two requirements to be deemed a law which regulates insurance and therefore, is saved from erisa preemption: "first, the law must be specifically directed toward entities engaged in insurance. second, ... the state law must substantially affect the risk pooling arrange­ ment between the insurer and the insured!'123 c. doctrinal and policy implications of the changes to the basic savings clause analysis the supreme court in rush and kahp added significant refinements to the basic savings clause analysis. overall, it is fair to say that the cases relaxed, broadened, and streamlined the analysis. yet, the cases have also raised questions about the proper application of the savings clause to state managed care reform laws; it is still not clear whether the savings clause would encompass state laws allowing civil actions that are essentially medical malpractice lawsuits against managed care organizations for negligent denials of claims based on medical necessity determinations. the cases have streamlined the analysis to a more straightforward assessment of thewho and the what of the state law at issue. prior to the cases, the courts used multiple factors to assess whether the law looked, from a common sense perspective, like a regulation of insurance. in applying the common sense test, courts considered both who and what was being regulated; courts also considered the mccarran-ferguson factors to help ensure that a law was properly characterized as a law regulating insurance. mter rush and kahp, parsing the who and what of the law remains the crux of the analysis. to assess the who aspect of a law, the court focused on identifying whether the law imposes duties, obligations, or rights primarily on entities which engage in insurance-type activities. neither an effect on other entities nor minimal over-breadth in the law will suffice to negate the law as a regulation of insurance. this aspect of the cases suggests that many state managed care reform laws, which typically target hmos and other mco arrangements, will satisfy the specifically directed prong of the analysis. 121. ky. ass'n of health plans, 123 s. ct. at 1478. 122. id. at 1479. 123. ld. 76 indiana heal1h law review [vol. 1:51 however, the cases did not address the supreme court's reasoning articulated in pilot life for its holding that a state common law bad faith breach of contract action was not specifically directed at the insurance industty.124 in pilot life, the specific cause of action at issue was applicable only to those in the insurance industry, but the state law cause of action evolved from general principles of tort and contract law, which obviously, were-not applicable only to insurers.125 this consideration was not relevant in rush and karp because the cases involved state laws enacted by legislatures that did not simply evolve from pre-existing general principles. because the court in rush and karp did not expressly or impliedly overrule this aspect of pilot life, it is reasonable to conclude that this reasoning is still relevant to the inquiry. 126 to parse out the what aspect of the state law, the court in kahp pro­ nounced that the analysis should focus simply on whether the state law has a substantial effect on the risk pooling arrangement between the insurer and.fhe insured. as noted, this language and the break from the mccarran-ferguson factors 'should result in a broader application of the savings clause. laws may be saved even if they fail to meet the more stringent concept of the business of insurance. the emerging questions, however, are twofold. first, what does justice scalia's new terminology mean? second, will the new terminology prove to be a workable and sufficient test for deciding whether a state law should be characterized as a law regulating insurance, and thus saved from erisa preemption? entities which provide health coverage arrangements engage in numerous functions and strategies in the course of providing their risk pooling arrangements. state laws regulate many of those strategies. 127 will those laws, many of which are viewed as traditional laws regulating insurance, be exempt from erisa preemption under the new terminology? first, what does the new language mean? what is the "risk pooling arrangement between the insurer and the insured?" generally, private health coverage products pool individuals' risk of high health care costs across a large number of people, permitting them to pay a premium based on the /d. 124. pilot life ins. co. v. dedeaux. 481 u.s. 41, 50-51 (1987). 125. /d. at 50. even though the mississippi supreme cotnt has identified its law of bad faith with the insurance industry, the roots of this law are firmly planted in the general principles of mississippi tort and contract law. any breach of contract, and not merely breach of an insurance contract, may lead to liability for punitive damages under mississippi law. 126. as explained infra, this-factor complicates application of the recent cases to state hmo liability laws. see infra notes 268-70 and accompanying text. 127. see infra notes 129-38 and accompanying text 2004] recent modiflcations to tile preemption doctrine 77 average cost of medical care for the group of people.128 thus, any health coverage product constitutes a risk pooling arrangement. justice scalia's terminology, then, would encompass any state law with a substantial effect on any health coverage product. what does that mean? &tities that sell or provide health insurance products engage in numerous strategies in order to make the risk pooling arrangement viable and profitable. for example, risk pooling should result in expected costs that are predictable. accordingly, coverage providers strive to maintain risk pools of people whose health on average is the same as that of the general population, thus avoiding adverse selection; that is, attracting a dis­ proportionate share of people in poor health.129 underwriting is the primary strategy used to maintain predictable and stable levels of risk within various risk pools. underwriting is the process used to determine whether to accept an applicant for coverage and to determine the terms of coverage. 130 one of the most efficient underwriting strategies to avoid adverse selection is to pro­ vide coverage to large groups of people already in existence, such as employees of large employers.131 underwriting is also used to determine the appropriate premium.132 for large groups, the premium is ba8ed on considerations such as claims history of the group, age distribution, industry, and geographic location.133 adverse selection is also controlled through the use of limited open enrollment periods for persons in the large group and through the use of preexisting condition exclusions. 134 additionally, providers of health coverage typically have multiple risk pooling arrangements, such as separate arrangements for different markets (small business versus trade association) or plans with different deductibles. 13s this type of product differentiation protects the insurer because problems in one risk pooling arrangement will not have a direct effect on people participating in another pooling arrangement.136 would justice scalia's new terminology encompass state laws regulating the basic strategies used by insurers to help ensure a viable and profitable product? that is, will the new terminology prove to be a workable and a sufficient test for deciding whether a state law should be characterized as a law 128. see generally gary claxton, henry i. kaiser family found., how private insurance works: a primer (apr. 2002), available at http://www.kff.orgfmsurancel loader.cftn?url::/commonspot/security/getfile.cfm&pageid=14053 [hereinafter kaiserprimer on insurance]. 129. id. at 4. "said another way, health coverage providers take steps to avoid attracting· a disproportionate share of people in poor health into their risk pools, which often is referred to as adverse selection.'' id. 130. id. at 5. 131. ld. at 6. 132. id. at 5. 133. kaiser primer on insurance, supra note 128, at 6. 134. ld. 135. id. at 4. 136. ld. 78 indiana health law review [vol. 1:51 regulating insurance and thus saved from erisa preemption? the prelimin­ ary answer would seem to be yes. state laws regulating the underwriting process would seem to have a substantial effect on the product offered by an insurer to an insured. for example, states have typically enacted laws relating to insurance and the underwriting process, such as laws regulating: licensing of entities providing health coverage; financial standards (minimum capital, investment practices, claims & other reserves); management; market conduct/business practices (advertising, marketing standards); policy fonns; access to coverage (guaranteed issue & guaranteed renewability); mandated benefits laws; restrictions on preexisting condition exclusions; premiums (loss ratios, rate bands, community rating); breach of contract/bad faith breach; and unfair claims practices. 137 further, state laws enacted pertaining more specifically to hmos and mcos practices include laws regulating: utilization review (''ur,,) standards; quality assurance/quality improvement programs; grievance processes; health care provider agreements; network adequacy; credentialing of health care providers; independent external review; malpractice for failure to use care in delivery of care; and negligent determination that recommended treatment is not medically necessary.138 all of the aforementioned types of state regulation arguably have an important effect on the product offered to policyholders. for example, a law regulating marketing standards may help ensure that consumers receive what is promised in tenns of the quality of the health coverage product; laws regulating premiums affect the level of risk that a coverage provider will provide in its products. additionally, policyholders care about standards for ur and the type of grievance process that is available. thus, state laws 137. /d. at 7-12 (describing typical state laws regulating insurance practices). 138. /d. (describing typical state laws regulating insurance practices). 2004] recent modifications to 1he preemption doctrine 79 regulating these and other aspects of health coverage affect, in an important way, the product offered to consumers or policyholders. admittedly, it is not clear that an "important effect" satisfies justice scalia's requirement of a "substantial effect." however, given the supreme court's overall implication that a broader view of what constitutes a law regulating insurance is appropriate, it is reasonable to conclude that the effect of managed care reform laws on the product offered to policyholders is sufficiently substantial to satisfy the test. thus, such state laws would seem to have the requisite effect on the risk pooling arrangement between the insurer and the insured. accordingly, most insurance and managed care reform laws would be saved and exempt from erisa preemption (i} as long as the laws also can be characterized as being specifically directed towards the insurance industry and (2) unless the conflict preemption exception to the savings clause suggests that preemption is appropriate, even though the law may be characterized as regulating insurance. as the next part of this article explains, after rush, this possibility is considerably circumscribed. iv. rush's intricate refinements to the conflict preemption exception whether a state law is saved from preemption hinges predominantly on application of the basic standards discussed in the previous part of this article. but not exclusively. rather, the supreme court has narrowed the scope of laws exempt from preemption by the savings clause by injecting into the analysis a moderating factor or exception to saving a state law that regulates insurance. in rush, the majority opinion carefully drew new lines relating to the conflict preemption exception; lines which strengthened the power of the savings clause to exempt laws from preemption. one line constitutes a general limit on the role of conflict preemption as an exception to the operation of the savings clause. a second line more narrowly construes any exception to the savings clause for state laws that arguably conflict with § 502(a), erisa's civil enforcement provision. a. pre-rush application of conflict preemption principles in contrast to the basic savings clause standards, the moderating factor or conflict preemption exception has only rarely been central to the savings clause analysis. yet, the supreme court has clearly indicated that it is important to consider whether application of the savings clause to a particular state law comports with the role of the "savings clause ... as a whole," thereby 80 indiana health law rev1ew [vol. 1:51 allowing consideration of whether saving the state law will further the objectives of erisa.139 most notably, this consideration was a central aspect of the court's savings clause analysis in pilot life, which involved state common law causes of action grounded in allegations of improper processing of the plaintiffs claims for benefits.140 in pilot life, the court stated, "in expounding a statute, we must not be guided by a single sentence or member of a sentence, but look to the provisions of the whole law, and to its object and policy."141 the court explained that saving the common law causes of action would be inconsistent with § 502(a), erisa' s civil enforcement section that, according to the court, congress intended as the exclusive vehicle for redressing assertions of improper processing of a claim for benefits. the court described § 502(a) as "represent[ing] a careful balancing of the need for prompt and fair. claims settlement procedures against the public interest in encouraging the formation of employee benefit plans."142 as used in pilot life, the conflict preemption consideration arguably is best characterized as an additional assessment in the savings clause analysis; a factor to consider before ultimately concluding that a law regulating ipsur;. ance should be saved. however, the conflict preemption consideration has been broadened by the court in later cases, such that it could also fairly be . characterized as an additional assessment in the basic § 514(a) preemption clause analysis. for example, in ingersoll-rand co. v. mcclendon, 143 the court examined a state common law action for wrongful discharge. the texas courts had created an exception to the doctrine of at-will employment where an employee was unlawfully discharged primarily because of the employer's desire to avoid contributing to, or paying benefits under, the employee's pension fund.144 in holding that the state cause of action was preempted under § 514 of erisa due to its relation to erisa plans, the court was influenced by the fact that erisa itself prohibits discrimination for the purpose of interfering with the attainment of any right under a pension plan and, therefore, by the fact that the texas cause of action would have provided a legal remedy beyond the equitable remedy expressly allowed by erisa § 502(a).145 139. see, e.g., pilot life ins. co. v. dedeaux, 481 u.s. 41,51-52 (1987). 140. ld. 141. /d. at 51 (quoting kelly v. robinson, 479 u.s. 36,43 (1986)). 142. id. at 54. 143. ingersoll-rand co. v. mcclendon, 498 u.s. 133 (1990). 144. /d. at 136. 145. /d. at 142-45. the court in ingersoll-rand also was influenced by the. fact that the texas causes of action were premised on the existence of a pension plan. /d. at 139-40. that is, if no pension plan exists, there can be no cause of action; thus, the duty imposed on employers arises only if an erisa plan exists. /d. 2004] recent modifications to the preemption doctrine 81 additionally, in new york state conference of blue cross & blue shield v. travelers insurance co., 146 the court recounted its prior preemption cases in which state laws had been found to relate to erisa plans and concluded that preempted state laws either (1) mandated employee benefit structures or administrative practices of plans or (2) provided "alternative enforcement ·mechanisms" within the scope of erisa's civil enforcement provisions.147 whether viewed as an exception to the savings clause or as part of the "relates to" preemption analysis, the court in pilot life and ingersoll-rand readily sent a signal that conflict preemption is an important aspect of an erisa preemption analysis. that importance was emphasized in other erisa preemption cases as well. for example, in john hancock mutual life insurance co. v. harris trust & savings bank, the supreme court held that a state law regulating insurers' conduct in relation to management of general assets of the insurer was preempted due to the conflicting directive in erisa that insurers manage certain funds in their general assets for the exclusive benefit of erisa plan participants and beneficiaries. 148 the insurer had argued that erisa must yield to a state law regulating insurance. the court stated, however: [w]e discern no solid basis for believing that congress when it designed erisa, intended fundamentally to alter traditional preemption analysis. state law governing insurance generally is not displaced, but 'where [that] law stands as an obstacle to the accomplishment of the full purposes and objectives of congress,' federal preemption occurs.149 similarly, in boggs v. boggs, which addressed erisa preemption of a state community property law. the court stated that "( c )onventional conflict pre­ emption principles require pre-emption . . . 'where state law stands as an obstacle to the accomplishment and execution of the full purposes and objec­ tives of congress. "'150 thus, although not as firmly a part of the savings clause analysis as the basic savings clause standards, consideration of conflict preemption principles seemed to be well established prior to rush. yet, the 146. n.y. state conference of blue cross & blue shield v. travelers ins. co., 514 u.s. 645 (1995). 147. /d. at 658 (citing ingersoll-rand, 498 u.s. at 133). 148.1ohnhancockmutllielns.co.v.harristrust&sav.bank,510u.s.86,99(1993). 149. /d. at 99 (quoting silkwood v. kerr-mcgee corp, 464 u.s. 238,248 (1984)). the court also stated, "erisa leaves room for complementary or dual federal and state regulation, and calls for federal supremacy when the two regimes cannot be hannonized ..•. " /d. at 98. in a footnote, the court stated, "no decision of this court has applied the savings clause to supersede a provision of erisa itself." id. at 99 n.9. 150. boggs v. boggs, 520 u,s. 833, 844. (1997) (quoting gade v. nat'l solid wastes mgmt a$s'n, 505 u.s. 88, 98 (1992)). · 82 indiana health law review [vol. 1:51 majority in rush significantly limited the role of conflict preemption in the erisa preemption context. b. rush's application of conflict preemption principles rush hmo presented several arguments grounded in the supreme court's recognition of a role for conflict preemption in the erisa preemption context. these arguments emphasized that exempting the dlinois ier law from preemption was inconsistent with congress' intention to provide through erisa a uniform federal regime of rights and obligations for employers, erisa plans, and erisa plan participants and beneficiaries. importantly, the court was unable to dispose of rush hmo' s conflict preemption arguments as readily as those pertaining to the basic savings clause standards. indeed, the court split five to four on the issue of whether the state law frustrated congres­ sional intent and thus should be preempted notwithstanding its characterization as a law regulating insurance. rush hmo's overarching contention was that the ier law interfered with congress' vision of a uniform enforcement scheme by creating an alterna­ tive remedy; that is, a process that supplements or supplants the federal scheme by allowing erisa plan participants and beneficiaries to obtain remedies under state law that congress rejected in erisa. more specifically, rush hmo argued that the ier law created a ''form of binding arbitration that allows an erisa beneficiary to submit claims to a new decision-maker to exa­ mine rush's determination de novo, supplanting judicial review under the 'arbitrary and capricious' standard ordinarily applied when discretionary plan interpretations are challenged."151 the dissent agreed. the ier law "cannot be characterized as anything other than an alternative state-law remedy or vehicle for seeking benefits .... [i]t is in fact a binding determination of whether benefits are due .... [it] is thus most precisely characterized as an arbitration-like mechanism to settle benefits disputes.''152 moreover, the dis­ sent noted that, because thejudicialreviewpursuantto a§ 502(a)(l)(b) action would be limited, the ier law "establishes a system of appellate review of benefits decisions that is distinct from" that provided for in erisa.153 accord­ ing to the dissent, the exclusivity and uniformity of erisa • s enforcement scheme must remain supreme, and the ier law was therefore preempted under ordinary principles of conflict preemption.154 the majority disagreed, however; as noted, it did so by intricately draw­ ing new lines marking the boundaries of erisa preemption. one line consti­ tutes a general limit on the role of conflict preemption as an exception to the 151. rush prudential hmo, inc. v.moran, 536u.s. 355,378 (2002)(citingfirestonetire & rubber co. v. bruch, 489 u.s. 101,110..12 (1989)). 152. id. at 394-95 (thomas, j., dissenting). 153. id. (thomas, j., dissenting) (quoting judge posner's statement in his dissent from the denial of rehearing en bane. moran v. rush prudential hmo, inc., 230 f.2d 959, 973 (2000)). 154. id. at 401 (thomas, i., dissenting). 2004] recent modifications to the preemption doc1rine 83 operation of the savings clause. iss a second line more narrowly construes any exception to the saving clause for state laws that arguably conflict with § 502(a), erisa's civil enforcement provision.156 as with the court's holding relating to the basic standards, the lines relating to the conflict preemption exception strengthen the power of the savings clause to exempt laws from preemption. 1. narrowing congressional objectives relating to§ 502(a) in addressing the exception to the savings clause for state laws arguably in conflict with erisa § 502(a), 157 the majority in rush, using a common law analysis approach, narrowed the exception to the precise contours of key precedent. more specifically, justice souter, writing for the majority, traced the case law origins of the exception and carefully explained the issues and holdings of the relevant cases and construed the key precedents as limiting any exception to the savings clause to state laws constituting only certain types of alternative causes of action, which would give rise to alternative remedies. the key precedent included russell, taylor, ingersoll-rand, and pilot life. justice souter emphasized that massachusetts mutual life insurance co. v. russell158 involved a claimant pursuing types of damages other than those specified in erisa via an erisa § 502 claim for benefits, and that the court in russell rejected the concept of "causes of action under erisa itself' beyond those specified in § 502(a).159 regarding metropolitan life insurance co. v. taylor,160 which involved complete preemption of a claim for benefits pled as a state law cause of action, justice souter placed emphasis on the court's holding that congress had so completely preempted the field of benefits law that an "ostensibly state cause of action for benefits was necess­ arily a 'creature of federal law' removable to federal court."161 similarly, justice souter explained that in ingersoll-rand, 162 the court rejected a state tort claim for wrongful discharge which duplicated the elements of a claim available under erisa, but which would have converted the equitable remedy available under erisa into a legal remedy for money damages.163 justice souter then addressed pilot life, which involved an erisa plan participant who had been denied disability benefits. 164 the claimant sued in state court on state tort and contract claims and sought damages for breach of contract, damages for emotional distress, and punitive damages. justice souter 155. see infra notes 178-96 and accompanying text. 156. see infra notes 157-77 and accompanying text. 157. see rush, 536 u.s. at 377-80 (noting section id(a) of justice souter's opinion). 158. mass. mut. life ins. co. v. russell, 473 u.s. 134 (1985}. 159. rush, 536 u.s. at 378. 160. metro. life ins. co. v. taylor, 481 u.s. 58 (1987). 161. rush, 536 u.s. at 378 (emphasis added). 162. ingersoll-rand co. v. mclendon, 498 u.s. 133 (1990). 163. rush, 536 u.s. at 379. 164. pilot life ins. co. v. dedeaux. 481 u.s. 41 (1987). 84 indiana health law review [vol. 1:51 placed emphasis on the court's holding in pilot life that, in a case where a claimant was pursuing payment of benefit amounts under an erisa plan, erisa "would not tolerate a diversity action seeking monetary damages for breach generally and for consequential emotional distress," when neither damages for breach nor for emotional distress were explicitly authorized in § 502(a). 165 that is, erisa§ 502(a)(l)(b) authorizes a suit for benefits due, and if the action is really about benefits due, additional damages beyond those authorized by§ 502(a) are impermissible. thus, justice souter stressed that, in each earlier case, the state law at issue provided a vehicle for a claimant to pursue, in essence, a claim that was actually available under erisa-that is, claims for breach of the duty to pay benefits due and a claim for discrimination prohibited by erisa. and, at the same time, the state law would have resulted in a remedy other than those specified in erisa. moreover, justice souter stressed that the monetary awards at issue in the cases were pursued as remedies, which would be "pro­ vided at the ultimate step of plan enforcement;''166 that is, the laws "provided a form of ultimate relief in a judicial forum that added to the judicial remedies provided by erisa."167 the desire to keep the scope of any exception to the savings clause narrowly confined to the contours of the noted cases was emphasized in other statements made by justice souter in distinguishing the illinois ier law. justice souter stated that the ier law "does not involve the sort of additional claim or remedy exemplified in pilot life, russell, and ingersoll-rand"168 and "imposes no new obligation or remedy like the causes of action considered in russell, pilot life and lngersoll-rand."169 a majority of the court joined in justice souter's opinion, thereby agreeing with this narrow, common law analysis approach to the key conflict preemption pre­ cedent. the dissent, however, did not agree with the majority's narrow view of impermissible "alternative enforcement mechanisms," noting that the court had previously focused on erisa's "overall enforcement mechanism and remedial scheme."170 moreover, the dissenting justices thought that the lllinois ier law represented the type of remedy precluded by erisa and the court's prior cases: "[the ier law] cannot be characterized as anything other than an alternative state-law remedy or vehicle for seeking benefits .... [the law] comes into play only if the hmo and the claimant dispute the claimant's 165. rush, 536 u.s. at 378-79. 166. id. at378 (emphasis added) (describing the laws atissueinmetropolitanlife,russell, and pilot life). 167. id. at 379 (describing the state wrongful termination action at issue in ingersollrand). 168. id. at 380 (emphasis added). 169. id. at 386 (emphasis added). 170. i d. at 397 (thomas, j ., dissenting). "[t]he court until today had consistently held that state laws that seek to supplant or add to the exclusive remedies in§ 502(a) of erisa ... are pre-empted because they conflict with congress' objective that rights under erisa are to be enforced under a uniform national system; rush, 536 u.s. at 393. 2004] recent modifications to lhe preemption docrr1ne 85 entitlement to benefits; [and] the purpose of the review is to determine whether a claimant is entitled to benefits."171 the dissent viewed the ier law as creating "an arbitration-like mechanism to settle benefit disputes"172 "outside of, or in addition to, erisa's remedial scheme."173 the majority, however, concluded that the ier law "does not involve the sort of additional claim or remedy exemplified in pilot life, russell, and ingersoll-rand . ... "174 the law does not supplement or supplant the enforce­ ment scheme of§ 502( a) because "the relief ultimately available would still be what erisa authorizes in a suit for benefits under section [502(a)]"175namely the promised benefit and only the promised benefit. 176 the majority acknowledged some resemblance to arbitration but held that the state law simply did not constitute an alternate vehicle to obtain, at the ultimate step of plan enforcement, a remedy different than that allowed by erisa. 177 because the law did not represent the sort of claim or the sort of remedy at issue in pilot life, russell, and ingersoll-rand, the law. was not an impermissible alternative enforcement mechanism. moreover, as explained in the following subsection, the majority was unwilling to recognize any other type of conflict with erisa as justifying preemption of a state law otherwise found to be exempt under the savings clause analysis. 2. limiting the role of conflict preemption in the erisa preemption analysis rush hmo also argued that the court should apply conflict preemption principles beyond conflicts with erisa' s civil enforcement provision and find that erisa supersedes state laws that frustrate the more general congressional objectives underlying erisa. the majority acknowledged that sometimes conflict preemption principles may impact the erisa preemption analysis; namely, when congressional intent is so clear that it overrides the otherwise applicable savings clause provision.178 the majority in rush, however, sug­ gested that it had previously recognized only one such overpowering federal policy in erisa: the policy underlying erisa' s civil enforcement provisions, which the majority found protected by the narrow approach just explained. 179 notably, the court did not attempt to distinguish, in any way, prior cases in which the court had more broadly suggested that laws frustrating congres­ sional objectives in erisa should be found preempted by erisa. 171. id. at 394 (thomas, j., dissenting). 172. id. at 395 (thomas, j., dissenting). 173; /d. at 398 (thomas, j., dissenting). 17 4. id. at 380. 175. id. 176. rush, 536 u.s. at 380. notably, moran was pursuing simply a remedy of ''benefits due" via a§ 502(a)(l)(b) claim. id. 177. id. at 382-84. 178. id. at 375-76, 381. 179. ld. 86 indiana health law review [vol. 1:51 in rush, after narrowing the scope of conflict preemption due to erisa's civil enforcement provisions, the majority expressly opined that "further limits on insurance regulation preserved by erisa are unlikely to de­ serve recognition."180 this statement purports to limit the role of conflict pre­ emption in the erisa context. that is, the majority rejected the idea that a state law regulating insurance could ever be preempted due to its frustration of, for example, congressional intent to "avoid a multiplicity of regulation in order to permit the nationally uniform administration of employee benefit plans."181 the majority provided no reason for expressing such a limitation. furthermore, the court did not attempt to distinguish john hancock or boggs, both of which involved a conflict with provisions of erisa other than erisa's civil enforcement provisions. john hancock involved a state law regulating insurance, which was nonetheless found to be preempted because of its conflict with the fiduciary duties imposed by erisa. 182 boggs involved a state law which the court found to be preempted due to a conflict with two other erisa provisions; one mandating the form of annuity benefits payable upon retirement, 183 and one creating an exception to the general prohibition on alienation of erisa benefits. 184 in contrast, the dissent construed the role of conflict preemption in the erisa context as much more substantial. 185 thus, due to the law's mandate that hmos provide coverage for services deemed medically necessary by the independent reviewer, the dissent viewed the law as being in conflict with erisa due to an impermissible effect on the system of judicial review of benefit decisions via § 502(a) actions.186 traditional judicial review of a denial of benefits involves interpreting the plan terms or analyzing whether the plan 180. ld. at 381. 181. n.y. state conference of blue cross & blue shield v. travelers ins. co., 514 u.s. 645, 657 (1995). the quoted language is from travelers, wherein the court articulated the "basic thrust of the preemption clause" for purposes of applying what, in essence, has become an implied preemption analysis when ascertaining whether a state law "relates to" an erisa plan. ld. · 182. see john hancockmut. life ins. co. v. ranis trust& sav. bank. 510 u.s. 86,97101 (1993). 183. see boggs v. boggs, 520 u.s. 833, 841 (1997). 184. see id. at 843-45. 185. rush, 536 u.s. at 389 n.1 (citing boggs, the dissent rioted that "[w]e can begin and end the pre-emption analysis by asking if [the ier law] conflicts with the provisions of erisa." ld. the dissent also noted that [w]hile the preeminent federal interest in the uniform administration of employee benefit plans yields in some instances to varying state regulation of the business of insurance, the exclusivity and uniformity oferisa's enforcement scheme remains paramount. . . . in accordance with ordinary principles of conflict pre-emption, therefore, even a state law 'regulating insurance' will be pre-empted if it provides a separate vehicle to assert a claim for benefits outside of, or in addition to, erisa's remedial scheme. ld. at 393-94 (thomas, j., dissenting). (citing pilot life ins. co. v. dedeaux, 481 u.s. 41 (1987); mass. mut. life ins. co. v. russell, 473 u.s. 134, 146 (1985)). 186. ld. at 394-95 (thomas, j., dissenting). 2004] recent modifications to the preemption doctrine 87 provided the full and fair review required by erisa -often using a deferential level of scrutiny. in contrast, the ier law would render judicial review a matter of "rubberstamping" or enforcing the reviewer's judgment.187 simil­ arly, the dissent believed that, because many other states have enacted similar laws but with varying "applicability, procedures, standards, deadlines, and consequences," saving the laws from preemption "is wholly destructive of congress' expressly stated goal of uniformity in this area ... [and] inimical to a scheme for furthering and protecting 'the careful balancing of the need for prompt and fair claims settlements procedures against the public interest in encouraging the formation of employee benefit plans. "'188 the majority, however, was unconcerned about the impact of the process on the scope of judicial review because nothing in erisa itself mandates the "standard of review" in § 502(a)(l)(b) actions. 189 the majority further explained: not only is there no erisa provision directly providing a lenient standard for judicial review of benefit denials, but there is no requirement necessarily entailing such an effect even indirectly. when this court dealt with the review stand­ ards . . . we held that a general or default rule of de novo review could be replaced by deferential review if the erisa plan itself provided that the plan's benefit determinations were matters of high or unfettered discretion. nothing in erisa, however, requires that these kinds of decisions be so 'discretionary' in the first place; whether they are is simply a matter of plan design or drafting of an hmo contract. in this respect, then, [the ier law] prohibits designing an insurance contract so as to accord unfettered discretion to the insurer to interpret the contracts terms. as such it does not implicate erisa's enforcement scheme at all, and is no different from the types of substantive state regulation of insurance contracts we have in the past permitted to survive preemption, such as mandated-benefit statutes and statutes prohibiting the denial of claims solely on the ground of untimeliness. 190 additionally, the majority was equally unconcerned about varying state laws mandating ier. "such disuniformities ... are the inevitable result of the con187. !d. 188. !d. at 400 (thomas, j., dissenting). 189. rush, 536 u.s. at 385. "[w]e have read [the statute] to require a unifonnjudicial regime of categories of relief and standards of primary conduct, not a uniformly lenient regime of reviewing benefit determinations." !d. (citing pilot life, 481 u.s. at 56). 190. !d. at 385-86. 88 indiana heal til law review [vol. 1:51 gressional decision to 'save' local insurance regulations."191 furthermore, in a footnote, the majority noted that the varying ier laws would not imper­ missibly burden erisa plans: "[l]it is the hmo contracting with a plan, and not the plan itself, that will be subject to these regulations .... this means there will be no special burden of compliance upon an erisa plan .. ~ .''192 however, it is perhaps important that, in another footnote, the majority noted that it simply did not perceive any conflict between the ier provision and any specific erisa directive.193 more particularly, the court noted that it did not see a conflict with the erisa provision that directs erisa plans to have an internal claims review process in accordance with regulations pro­ mulgated by the secretary.194 the court noted that erisa merely requires that plans provide "internal appeals ofbenefit denials;" and the ier law "plays no role in this process, instead providing for extra review once the internal process is complete.''195 although somewhat disingenuous since the court did not expressly explain why the erisa directive did not impliedly indicate that congress intended the secretary's regulations regarding the internal appeals process to constitute the sole regulation of an appeals process, this arguably leaves the door open for a case where a state insurance law more clearly is in direct conflict with an erisa provision other than § 502(a).196 c. doctrinal and policy implications as with the court's recent holdings relating to the basic savings clause standards, the holdings of the majority opinion in rush relating to the conflict preemption exception strengthened the power of the savings clause to exempt laws from preemption~ however, the holdings strengthened and broadened the savings clause in different ways. the holdings related to the basic savings clause standards make it more likely that managed care reform laws will be found exempt from erisa preemption because they constitute laws regulating insurance. the rush majority's holdings related to the conflict preemption exception will come into play primarily when a state law has been found to be 191. id. at 381 (quoting metropolitan life ins. co. v. massachusetts, 471 u.s. 724, 747 (1985)). 192. id. at 381 n.11. the majority added that the costs of compliance passed on to the erisa plan likely would not rise to the impermissible level triggering preemption. jd. the dissent noted that "isolat[ing] the 'plan' from the hmo" was a "novel" view; especially where the hmo is a plan administrator. rush, 536 u.s. at 401 n.9 (thomas, j., dissenting). 193. id. at 385 n.16. 194. id. 195. ld. (citing erisa§ 503(2), 29 u.s.c. § 1132(2) (2003)). 196. /d. at 386 n.17. the court also arguably left the door open for further expansion of the conflict preemption exception by noting that the decision rested in part on the recognition that "the disuniformity that the congress hoped to avoid is not implicated by decisions that are so heavily imbued with expert medical judgments." id. this statement arguably suggests that, again, the court in this case was somewhat influenced by the fact that the ier provisions looked like state regulation of medical decision-making. rush, 536 u.s. at 366 n.17. 2004] recent modifications to the preemption doctrine 89 a law regulating insurance, but seems inconsistent in some way with erisa itself: despite inconsistence, the narrowing of the conflict preemption exception will make it more likely that the law is nonetheless exempt from erisa preemption.197 the majority inrush significantly limited the effectiveness of arguments that a state law regulating insurance should nonetheless be preempted due to a conflict with erisa itself. foremost, the majority limited the exception to state insurance laws that conflict with the congressional objectives underlying only § 502(a) and specifically rejected the idea that a state law regulating insurance could ever be preempted due to its frustration of, for example, congressional intent to "avoid a multiplicity of regulation in order to permit the nationally uniform administration of employee benefit plans."198 this limitation would seem to leave the states free to regulate a multitude of insurer and hmo practices relating to administration of the health benefits offered by employers, notwithstanding any resulting disuniformity.199 this result is arguably sound given the typical way in which employers set up insured erisa plans.200 with insured plans, the employer contracts with a provider of health coverage to provide the health insurance and, in most cases, to administer the plan. state laws regulating providers of health cover­ age relating to administration of that health coverage will, as the majority noted, burden the insurer or hmo and will not impermissibly burden erisa plans: "[i]t is the hmo contracting with a plan, and not the plan itself, that will be subject to these regulations .... this means there will be no special burden of compliance upon an erisa plan .... "201 further, this is true even 197. notably, it probably remains proper to view the conflict preemption principles as also providing a basis for a finding that a law "relates to" erisa plans and is therefore preempted. 198. blue cross & blue shield v. travelers ins. co., 514 u.s. 645, 657 (1995). the quoted language is from travelers, wherein the court articulated the "basic thrust of the pre­ emption clause" for purposes of applying what, in essence, has become an implied preemption analysis when ascertaining whether a state law relates to an erisa plan. !d. 199. rush, 536 u.s. at 381. according to the majority, "disuniformities ... are the inevitable result of the congressional decision to 'save' local insurance regulations." ld. 200. but see e. haavi morreim, erisa takes a drubbing: rush prudential and its implications for health care, 38 tort trial & ins. prac. l.j. 933 (2003). the author emphasized the negative implications arguably flowing from rush: [t]he court has endorsed a procedural remedy that quite clearly adds to erisa' s exclusively federal remedies. it has also permitted independent reviewers essentially to replace the role of erisa's fiduciaries in ways that appear to ignore if not outright contradict the statute. moreover, by permitting "medical necessity" to be interpreted in ways that need not even refer to the plan's own tertns, the court may well have substantially reduced employers' ability to predict and control the cost of employee benefits, a need that the court itself has acknowledged is integral to the goals of erisa. ld. at 934. 201. rush, 536 u.s. at 381 n.ll. the majority added that the costs of compliance passed on to the erisa plan likely would not rise to the impermissible level triggering preemption. i d. the dissent noted that "isolat[ing] the 'plan' from the hmo" was a "novel" view; especially where the hmo is a plan administrator. id. at 401 n.9 (thomas, j., dissenting). 90 indiana health law r.evlew [vol. 1:51 as to insurers or hmos that provide only administrative services to employers who self-insure. however, from a doctrinal perspective the majority's analysis is less satisfactory. as noted, the majority failed to explain the departure from the broader view of conflict preemption reflected in earlier cases. as explained, the court in john hancock stated: [w]e discern no solid basis for believing that congress, when it designed erisa, intended fundamentally to alter traditional preemption analysis. state law governing insurance generally is not displaced, but 'where [that] law stands as an obstacle to the accomplishment of the full purposes and objectives of congress,' federal preemption occurs. 202 the court in boggs stated that "[c ]onventional conflict pre-emption principles require pre-emption ... 'where state law stands as an obstacle to the accom­ plishment and execution of the full purposes and objectives of congress. "'203 both cases involved state laws found to frustrate congressional objectives other than those underlying erisa's civil enforcement provisions.204 from a doctrinal perspective, therefore, it is difficult to understand the court's strong rejection of the role of conflict preemption in the savings clause analy­ sis. the difficulty is compounded by the fact that the court was not required to make the categorical rejection, given that the court noted that it did not view the ier law as actually conflicting with any provision of erisa. 205 the majority in rush also significantly limited the exception even as to state laws that arguably conflict with the objectives underlying § 502(a). according to the dissenting justices, the majority has, in essence, created a new test, which warrants preemption of a state law regulating insurance only if the state law "'provides [a] new cause of action' or authorizes a 'new form 202. johnhancockmut.lifelns. co. v.harristrust&sav.bank,51()u.s. 86, 99(1993) (quoting silkwood v. kerr-mcgee corp., 464 u.s. 238, 248 (1984)). the court also stated, "erisa leaves room for complementary or dual federal and state regulation, and calls for federal supremacy when the two regimes cannot~ harmonized .... " ld. at 98. in a footnote, the court stated, "no decision of this court has applied the savings clause to supersede a provision of erisa itself." ld. at 99 n.9. 203. boggs v. boggs, 520 u.s. 833, 844 (1997) (quoting gade v. nat'l solid wastes mgmt. ass'n, 505 u.s. 88, 98 (1992)). 204. john hancock, 510 u.s. at 97-101. john hancock involved a state law regulating insurance which was nonetheless found to ~ ~ ~se of its conflict with the fiduciary duties imposed by erisa ld. see also boggs, 520 u.s. at 844. boggs involved a state law which the court found to be preempted due to a conflict with two other erisa provisions; one mandating the form of annuity benefits payable upon retirement and one creating an exception to the general prohibition on alienation of erisa benefits. id. 205. see /wsh, 536 u.s. at 385 n.15 (noting no conflict because erisa does not specify a standard of review for§ 502(ax1xb) actions); id. at 385 n.l6. (noting that erisa§ 1133 merely requires plans to provide an internal appeal, and thus that the external review required by the ier law does not create a conflict). 2004] recent modifications to the preemption doctrine 91 of ultimate relief.' "206 while more abbreviated, the dissent's characterization is compatible with this article's explanation that the majority opinion suggests a desire to limit the exception to state laws which provide a vehicle for an erisa claimant to pursue, via a civil action, a claim or cause of action that is, in essence, available under erisa, and which would allow a remedy not available in the erisa action.207 this aspect of rush arguably would leave states free to allow medical malpractice claims against hmos arising from allegedly negligent denials on the basis of medical necessity .. this assessment is arguable, however, because as explored in the next part of this article, important unanswered questions remain. v. appucation to stale "hmo liability" laws as noted, the question of the day is whether the supreme court ultimately will agree with the emerging judicial perspective that erisa does not preempt an erisa plan beneficiary's medical malpractice claim against an hmo which served as the plan administrator; that is, a claim arising from the hmo' s determination that medical services or treatments recommended by the treating physician are not medically necessary. as noted in the intro­ duction, some have construed rush as affirming the idea that erisa preempts state common law and legislative attempts to impose liability on managed care plans for violation of a duty of ordinary care in arranging for medically neces­ sary services. indeed, that view was highlighted in a december 2002 article in the health lawyer.208 that view of rush, however, is inconsistent with the majority's careful narrowing of the conflict preemption exception to the savings clause. a. state hmo liability laws the problems arising from hmo determinations that medical services or treatments recommended by treating physicians are not medically necessary have been addressed by states through laws in addition to laws requiring ier. one of the most controversial means is through a state law imposing liability 206. /d. at 397 (thomas, l, dissenting). 207. see supra notes 158-69 and accompanying text. the majority thus stressed that, in each earlier case, the state law at issue provided a vehicle for a claimant to pursue, in essence, a claim that was actually available under erisa (claims for breach of the duty to pay benefits due and a claim for discrimination prohibited by erisa); and yet would have resulted in a remedy other than those specified in erisa. moreover, the majority stressed that the monetary awards at issue in the cases were pursued as remedies which would be 'provided at the ultimate step of plan enforcement' /d. (emphasis added). 208. ste pimstone & johnson, supra note 20, at 7-9. see also infra notes 276-79 and accompanying text (describing the views set forth in this article). 92 indiana heal1h law review [vol. 1:51 on hmos for a failure to exercise appropriate care in making such a determination. that statelaw can either be common law, that is, judicial recognition that hmos owe a duty of reasonable care to their subscribers in making medical necessity-based utilization review determinations or, more commonly, a legislatively enacted law. because of the historical barrier posed by erisa preemption, state courts have had limited opportunities to develop common law liability claims against hmos. over the years, plaintiffs in many cases have included allega­ tions to the effect that the defendant hmo negligently determined that medical care or services recommended by their treating physician were not medically necessary.209 because the claims arose out of the process of determining whether a claim for benefits should be paid, defendants argued and lower courts agreed that the claims were preempted by erisa, thereby cutting off the opportunity to consider whether judicial recognition of the cause of action was proper. 210 in the recent cases, such as cicio, in which the courts have held that various negligence claims against hmos are not preempted, courts have carefully noted that the finding of no preemption did not mean that the cause of action was viable as a matter of state law.211 however, as cases have escaped preemption, state courts have begun recognizing a variety of common law negligence claims against hmos. 212 while medical malpractice claims are likely to emerge as a viable tool to hold hmos accountable for activity comparable to practicing medicine, it may be years before a body of case law develops. 213 209. see, e.g., moscovitch v. danbury hosp., 25 f. supp. 2d 74 (d. conn. 1998). 210. see, e.g., corcoran v. united healthcare, inc., 965 f.2d 1321 (5th cit. 1992). see also jordan. supra note 2, at 410 n.ls (citing a multitude of cases following corcoran over the years). /d. 211. see, e.g., cicio v. does, 321 f.3d 83, 106 (2d cir. 2003). [w]e reiterate that we do not decide unc:ler what circumstances, if any, the decisions made by [the hmo or its medical director], or utilization review decisions generally, may when negligently made be actionable under new york law. perhaps they never are •••. [t]hat will be a question for the new york courts to decide upon remand.· 212. see, e.g., jones v. chicago hmo ltd. ofid., 730 n.e.2d 1119 (id. 2000) (holding that the doctrine of institutional negligence may be applied to hmos); shannon v. mcnulty, 718 a.2d 828, 836 (pa. super. ct. 1998) (deciding that duties applicable to hospitals should also be applicable to hmos, when the hmo is performing similar functions). see also gail b. agrawal & mark a. hall, what if you could sue your hmo? managed care liability beyond the erisa shield, 47 st. louis u. l.j. 235, 279 (2003) (noting that insurance contracts give insurers discretion to determine uncertain issues requiring individual clinical assessments and that if an insurer's judgment was arl>itrary, unreasonable or incorrect, "the liability that results from any misfeasance raises issues [that] cannot be resolved without resort to concepts from the domain of tort law"). 213. see wickline v. state, 239 cal. rptr. 810 (cal. ct. app. 1986); wilson v. blue cross of s. cal., 271 cal. rptr. 876 (cal. ct. app. 1990). interestingly, the framework for analyzing hmo negligence may have its roots in cases decided before erisa preemption became the notorious shield against managed care liability. 2004] recent modifications to the preemption doctrine 93 in contrast, legislative hmo liability laws have been adopted in several states. the laws vary from state to state, but the objective of all is to provide a mechanism for holding hmos accountable when their utilization review decisions constitute, in essence, the exercise of medical judgment. in 1997, texas became the first state to enact legislation establishing a standard of care, and a cause of action for breaches thereof, for hmo benefit determinations which cause injury.214 to date, at least ten states have codified laws opening the door to managed care liability for inappropriate medical necessity deter­ minations.215 most impose a duty to exercise ordinary or reasonable care in making such determinations and allow injured plan participants to recover damages beyond the benefit itself. california's statute provides a good example of a state legislative hmo liability law. california's civil code section 3428 provides that managed care entities such as hmos shall have a duty of ordinary care to arrange for the provision of medically necessary health care service[ s] to its subscribers and enrollees, where the health care service is a benefit pro­ vided under the plan, and shall be liable for any and all harm legally caused by its failure to exercise that ordinary care when both of the following apply: ( 1) the failure to exercise ordinary care resulted in the denial, delay, or modification of the health care service re­ commended for, or furnished to, a subscriber or enrollee[; and] (2) the subscriber or enrollee suffered substantial harm.2j6 california, therefore, has legislatively imposed a tort duty on hmos to use ordinary care when the hmo is wearing its "provider hat." that is, the duty is imposed as to activities involved "in arranging for the provision of medically necessary health care."217 through use of this language, the duty extends to actions including denials of, or delays in approving, coverage for recommended medical services. indeed, the california statute specifically imposes liability on hmos for a denial of coverage resulting from a failure to 214. see tex. civ. prac. & rem. code ann. § 88.002 (vernon 2003) (codifying the health care liability act). 215. see generally patricia butler, henry j. kaiser family found., key char­ acteristics of state managed care organization liabiuty laws: current status and experience (aug. 2001) (including arizona, california, georgia, maine, oklahoma, texas, washington, and west virginia), available at http://www.kff.org/insurance/3155index.cfm. 216. cal. civ. code§ 3428 (west 2003). 217. id. 94 indiana health law review [vol. 1:51 satisfy the tort duty, when the denial legally causes substantial harm to an hmo subscriber or enrollee.218 the december 2002 article in the health lawyer specifically cited this california hmo liability law as an example of the type of state law that would be preempted under the author's view of rush.219 accordingly, this article will use california's hmo liability law as the basis for its exploration of the proper application of rush and kahp to the preemption analysis. whether state hmo liability laws are preempted depends on the following: (1) whether the laws relate to erisa plans and thus fall within the scope of§ 514(a); (2) if so, whether they are laws regulating insurance within the scope of§ 514(b)(2)(a) and, thus, generally are exempt from preemption; and (3) if so, whether the laws should nonetheless be preempted pursuant to conflict preemption considerations. the analysis of erisa preemption of state hmo liability laws is largely the same regardless of whether the laws are state common law or legislative enactments. accordingly, the following subsections explore the preemption analysis for both types of state hmo liability laws. b. state hmo liability laws "relate to" erisa plans section 514(a) of erisa preempts state laws that relate to erisa plans.220 although the supreme court has acknowledged the breadth of this express preemption language, the court has clarified that the analysis should be guided by the objectives of erisa and should involve consideration of the nature and purpose, as well as the effect, of the state law at issue.221 rather than any mere reference to an erisa plan, the court has stated that a reference will warrant preemption if the state law "acts immediately or exclusively upon erisa plans, ... or where the existence of erisa plans is essential to the law's operation."222 moreover, rather than any mere connec­ tion with an erisa plan, the court has stated that preemption is warranted if the law "mandate[s] employee benefit structures or their administration [or provides] alternative enforcement mechanisms [to erisa]."223 further, the court has emphasized the presumption against preemption of state laws in areas traditionally regulated pursuant to a state's domain over the health and welfare of its citizens.224 218. id. 219. see pimstone & johnson, supra note 20, at 8 (citing cal. civ. code§ 3428 (west 2003)). 220. see supra note 49 and accompanying text. 221. see n.y. state conference of blue cross & blue shield plans v. travelers ins. co., 514 u.s. 645 (1995). 222. see, e.g., cal. div. of labor standards enforcement v. dillingham constr. n.a., 519 u.s. 316, 325 (1997). 223. see travelers, 514 u.s. at 658. 224. see id. at 663. 2004] recent modifications to the preemption doctrine 95 1. impermissible "reference to" is unlikely preemption on the basis of an impermissible reference to erisa plans will, of course, always depend upon the precise language or terminology of the state of hmo liability law. a review of several state hmo liability laws shows that it is unlikely that such laws will impermissibly reference erisa plans. the laws typically impose the duty of care on health carriers225 or health insurance carriers, 226 managed care entities, 227 hmos,228 or organized delivery systems. 229 these terms typically are defined to reach entities with which an employer may contract to provide health coverage for its employees or to provide administrative services for employers that self-insure. as defined, the terms typically do not encompass the erisa plan itself. 230 the assertion that the laws do not reference erisa plans is confmned by the rush majority's view of an erisa plan. fu rush, justice souter rejected rush hmo's argument that differences in state independent review laws would impose impermissible burdens on erisa plan administration.231 writing for the majority, justice souter noted that "it is the hmo contracting with a plan, and not the plan itself, that will be subject to these regulations, and every hmo will have to establish procedures for conforming with the local laws, regardless of what this court may think erisa forbids.'m2 the dis­ senting opinion reiterated the majority's narrow view of what constitutes the erisa plan by noting that the "[majority] isolates the 'plan' from the hmo and then concludes that the independent review provision does not 'threaten 225. see wash. rev. code§ 48.43.545(l)(a) (2003); me. rev. stat. tit. 22, § 4313 (l)(a) (west 2003); n.j. rev. stat. § 2a:53a-33(a) (2003). 226. see tex. clv. prac. & rem. code ann. § 88.002(a) (vernon 2003); okla. stat. tit. 36, § 6593(a) (2003). 227. see tex. clv. prac. & rem. code ann. § 88.002(a) (vernon 2003); okla. stat. tit. 36, § 6593(a) (2003); n.c. gen. stat. § 90-21.5l(a) (2003). 228. see tex. civ. prac. & rem. code ann. § 88.002(a) (vernon 2003); okla. stat. tit. 36, § 6593(a) (2003). 229. see n.j. rev. stat.§ 2a:53a-33(a) (2003). 230. see wash. rev. code§ 48.43.005(18) (2003). for example, washington's hmo liability law imposes the duty on health carriers and defines that term to include a "disability insurer, ... a health care service contractor, ... or a health maintenance organization." /d. see tex.civ.prac. &rem. code ann.§ 88.001(8) (vernon2003). the texas hmo liability law imposes the duty on, inter alia, "managed care entities" and defines that term to include: i d. [a}ny entity which delivers, administers, or assumes the risk for health care services, with systems or techniques to control or influence the quality, accessibility, utilization, or costs and prices of such services, to a defined enrollee population, but does not include an employer purchasing coverage or acting on behalf of its employees .... 231. rush prudential hmo, inc. v. moran, 536 u.s. 355, 381 n.ll (2002). 232. ld. 96 indiana health law review [vol. 1:51 the object of [erisa]' because it does not affect the plan, but only the hm0."233 moreover, even if the law did use terminology that could arguably be construed as encompassing the erisa plan itself, it would be unlikely that the law would reach only erisa plans, as the laws will primarily target insurers, hmos, and other entities performing an insurance function. thus, it is unlikely that any state hmo liability law would be drafted such that it would act "immediately and exclusively upon erisa plans, ... or [create a situation] where the existence of erisa plans is essential to the law's operation .... "234 rather, preemption due to a relation to erisa plans is likely to result from an impermissible connection with erisa plans. 2. rush suggests an lmpennissible "connection with" the generally articulated principle is that preemption due to a connection with an erisa plan is warranted if the law "mandate[s] employee benefit structures or their administration [or provides] alternative enforcement mech­ anisms [to erisa]."235 applying this test focuses primarily on the effect of the state law on erisa plans. however, the nature and purpose of the law are also relevant, and the court has emphasized the presumption against pre­ emption of state laws in areas traditionally regulated pursuant to a state's domain over the health and welfare of its citizens.236 interestingly, prior to rush and kahp, scholars of erisa preemption and some lower courts believed that the supreme court was signaling that state laws regulating health care, and especially the quality of health care, should not be preempted because such laws did not relate to erisa plans. 237 rush and kahp suggest the same ultimate conclusion, but suggest a different approach to the analysis. for exploration of the "connection with" analysis, the second circuit's decision in cicio provides a useful starting point. recall that, in cicio, the 233. id. at 401 n.9 (thomas, j., dissenting). the dissent went on to note, "to my know­ ledge such a distinction is novel. ... its application is particularly novel here, where the court appears to view the hmo as the plan administrator, leaving one to wonder how the myriad state independent review procedures can help but have an impact on plan administration." id. however, the majority's view is not as illogical as justice thomas implicates. /d. it has long been recognized that the hmo or insurer with whom an employer contracts in order to provide health coverage through an erisa plan, although often serving as the plan administrator, also functions in other roles, such as administering the hmo's business-distinct from adminis­ trative functions that may constitute "administration of an erisa plan." jd. see, e.g., jordan, supra note 12, at 299-304 (exploring the concept of administration of erisa plans). 234. see, e.g., cal. di v. of labor standards enforcement v. dillingham constr. n.a, 519 u.s. 316, 325 (1997). 235. see n.y. state conference of blue cross & blue shield plans v. travelers ins. co., 514 u.s. 645, 658 (1995). 236. see id. 237. see, e.g., jordan, supra note 2, at 442-49 and infra notes 238-52 and accompanying text. 2004] recent modifications to the preemption doctrine 97 second circuit held that erisa did not preempt an erisa plan beneficiary's common law medical malpractice claim against an hmo, which served as the plan administrator, for an allegedly negligent medical decision to deny medical care recommended by the claimant's treating physician.238 the issue of preemption of the state common law hmo liability claim was one of first impression for the second circuit,239 and the court therefore was influenced only by the recent supreme court erisa preemption cases. the court began and ended its analysis with the strong presumption against preemption of state law in the field of health care. in the court's view, based on recent supreme court cases, the state common law civil action being pursued by the plaintiff constituted a state law regulating health care and, for that reason alone, was not preempted under§ 514(a) of erisa. that is, as a law regulating health care, the law simply did not impermissibly relate to erisa benefit plans. more specifically, the second circuit in cicio viewed the supreme court's decision in pegram v. herdrich240 as bearing significantly on the pre­ emption issue.241 in pegram, the claimant argued that the hmo breached the fiduciary duties imposed by erisa. thus, the court addressed only whether the challenged conduct, making ur decisions while influenced by financial incentives, constituted administrative acts triggering imposition of the erisa fiduciary duties.242 the court explained that ur decisions made by hmos (or 238. cicio. v. dees, 321 f.3d 83,87-88 (2d cir. 2003). in cicio, the plaintiff's physician recommended on january 28, 1998, "high dose chemotherapy supported by peripheral blood stem cell transplantation, in a tandem double transplant, for [mr. cicio's j diagnosis of multiple myeloma." /d. the hmo's medical director, dr. spears, on february 23, 1998, denied the request of cicio's physician (dr. samuel) for preauthorization. /d. dr. spears noted that the procedure was not covered because cico's health benefit plan stated that experimental/ investigational procedures were not covered. /d. on march 4, 1998, after unsuccessful attempts to contact dr. spears by telephone, dr. samuel wrote an appeal for reconsideration, noting that the recommended treatment was a well-established and effective treatment. /d. on march 25, 1998, dr. spears approved a single stem cell transplant, but again denied the original request for tandem stem cell transplant. /d. by march 25th, cicio was no longer a candidate for the transplant. cicio, 321 f.3d at 88. cicio died on may 11, 1998. /d. on appeal, the claims remaining challenged the timeliness of dr. spears's decisions; the allegedly misleading nature of the hmo's representations about cicio's health benefit plan; and the quality of the medical decision made by the defendants. /d. at 90. 239. /d. at 98. 240. pegram v. herdrich, 530 u.s. 211 (2000). 241. cicio, 321 f.3d at 100-03 (noting that other cases finding medical practice claims preempted were decided before the court's decision in pegram, and that pegram alters the framework used in prior cases by demonstrating that the presence of a medical component to a coverage decision is determinative). 242. in pegram, the plaintiff herdrich suffered injury when her physician, dr. pegram, discovered an inflamed mass in herdrich's abdomen, but delayed the allegedly necessary ultrasound diagnostic procedure. dr. pegram decided that herdrich could wait eight days in order to have the ultrasound performed at a facility staffed by carle care hmo, the hmo of which dr. pegram was both an owner and participating provider. pegram, 530 u.s. at 215. carle care hmo had contracted with herdrich' semployerto provide health coverage and administrative services for the employer's health benefit plan. accordingly, carle care hmo was subject to certain duties imposed by erisa. herdrich alleged that carle care hmo 98 indiana health law review [vol. 1:51 by physician owners of the hmo who also serve as the treating physician) fall into distinct categories: pure eligibility decisions, which tum on the plan's coverage of a particular condition or treatment;243 treatment decisions, which tum on issues of "how to go about diagnosing and treating a ... condition;"244 and "mixed eligibility and treatment decisions," which involve eligibility decisions that "cannot be untangled from physicians' judgments about reasonable medical treatment."245 the conduct challenged in pegram con­ stituted mixed eligibility and treatment ur decisions,246 and the court held that ur decisions which constitute mixed decisions do not constitute "administration of the plan," thereby defeating the plaintiffs claim for breach oferisa's fiduciary duty.z47 in supporting its decision, the court in pegram also noted that no breach of fiduciary duty action could be brought under erisa because, in part, such an action would be a mere replication of state malpractice actions with hmo defendants. 248 the court in pegram also noted that allowing the erisa claim would raise a "puzzling issue of preemption;" the court pointed out that allowing the claim would raise a problematic "prescription for preemption," given that travelers "throws some cold water" on the theory that erisa pre­ empts medical malpractice claims.249 the court in cicio therefore noted that the "availability of some state law malpractice actions based on at least some varieties of utilization review decisions was a predicate of the court's holding [in pegram]."250 although not a preemption case, the second circuit in cicio viewed the rationale used by the court in pegram as dictating that a mixed eligibility and treatment decision, that is, a ur determination made by a payor denying had breached erisa's fiduciary duty by devising a system of financial incentives which influenced treatment decisions made by its physician owners. ld. at 215-16, 216 n.3. 243. i d. at 228-29. for example, "whether appendicitis is a covered condition (when there is no dispute that a patient has appendicitis) .... " i d. 244. ld. for example, "given the patient's constellation of symptoms, what is the appropriate medical response?" ld. 245. pegram, 530 u.s. at 228-29. 246. in pegram, physician owners of carle care hmo also served as treating physicians. rather than having a process ofur distinct and separate from the treating physicians' decisions (as in a more typical managed care organization), the carle care hmo physicians made treatment decisions and the ur or coverage decision simultaneously. in pegram, the decision was whether herdrich required an immediate ultrasound performed at the local hospital or whether it was reasonable to have herdrich wait eight days for an ultrasound that could be performed at a carle care facility. the court found that this decision and the others mentioned in herdrich's complaint constituted mixed eligibility and treatment decisions. id. at 229-30. 247. ld. 248. ld. at 235 (noting that allowing a breach of fiduciary action arising from actions constituting the exercise of medical judgment would "simply apply the law already available in state courts and federal diversity actions today .... "). see also cicio v. dees, 321 f.3d 83, lol (2d cir. 2003) (quoting pegram, 530 u.s. at 236). 249. pegram, 530 u.s. at 236-37. the court in pegram of course did not expressly address the preemption issue being explored in cicio and in this article. 250. cicio, 321 f.3d at 101. 2004] recent modifications to the preemption doctrine 99 recommended care based on a finding regarding medical necessity or the experimental nature of the treatment for a particular hmo subscriber, con­ stitutes an exercise of medical judgment. 251 accordingly, the court held that the claimant's medical malpractice action "regulating" that conduct constitutes a state law regulating health care, and thus, is not preempted absent clear and manifest indication of congressional intent. 252 as noted, scholars have similarly viewed the recent supreme court cases involving the "connection with" analysis as supporting a finding that a state hmo liability law, as a law regulating health care does not sufficiently relate to erisa plans to warrant preemption.253 interestingly, the more recent supreme court cases, while supporting a holding that state hmo liability laws are not preempted, may not support cicio's approach to the preemption analysis. more specifically, it is not clear that rush supports cicio's resolution of the issue through a finding that the medical malpractice cause of action, as a regulation of health care, does not sufficiently relate to erisa benefits plans. in rush, the ier law at issue could also be characterized as a law regulating health care. yet, the court in rush summarily concluded that the law relates to an erisa plan and therefore was preempted, unless saved. 254 indeed, the majority in rush referred to the ier law as a law regulating health care. the majority noted that the law set in motion a process resemb­ ling the practice of obtaining another medical opinion.255 additionally, the court explained that states often regulate insurance in order to safeguard the welfare of their citizens. for example, "dlinois has chosen to regulate insur­ ance as one way to regulate the practice of medicine, which we have pre­ viously held to be permissible under erisa. "256 the court noted, [a]ny lingering doubt about the reasonableness of [the ier law] ... may be put to rest by recalling that regulating insur­ ance tied to what is medically necessary is probably insepar251. ld. at 102. the court noted that decisions regularly made by payers, such as '"whether one treatment option is so superior to another under the circumstances, and needed so promptly, that a decision to proceed with it would meet the medical necessity requirement' in a health benefits contract, 'cannot be untangled from physicians' judgments about reasonable medical treatment'" ld. (quoting pegram, 530 u.s. at 229). 252. ld. at 102 ("we conclude that a state law malpractice action, if based on a 'mixed eligibility and treatment decision,' is not subject to erisa preemption when that state law cause of action challenges an allegedly flawed medical judgment as applied to a particular patient's symptoms."). 253. see, e.g., jordan, supra note 2, at 442-49. 254. see rush prudential hmo, inc. v. moran, 536 u.s. 355, 365 (2002). ''it is beyond serious dispute ... that the [ier law] 'relates to' employee benefit plans .... " ld. 255. ld. at 383. "the reference to an independent reviewer is similar to the submission to a second physician, which many health insurers are required by law to provide before denying coverage." ld. 256. ld. at 387 (quoting pegram, 530 u.s. at 237). 100 indiana health law review [vol. 1:51 able from enforcing the quintessentially state-law standards of reasonable medical care. '[i}n the field of health care, a subject of traditional state regulation, there is no erisa pre­ emption without clear manifestation of congressional pur­ pose.'257 however, as noted, the court in rush found that the ier law related to erisa plans and viewed the determinative issue as whether the law regulated insur­ ance and thus was saved from preemption. 258 perhaps this was because the dlinois ier law represented a direct regulation of hmos and mcos, 259 as would a state hmo liability law. accordingly, although the most recent supreme court cases support the emerging view that state hmo liability laws are not preempted, they suggest that the outcome lies in the savings clause analysis. c. state hmo liability laws satisfy the broader view of laws regulating insurance based on the foregoing discussion, it could be argued that a full-blown savings clause analysis of state hmo liability laws is unnecessary because the supreme court's recent precedent at least arguably still suggests simply that, if the law is a law regulating health care, it is not preempted. it is possible that such an argument is correct however, in this author's view, it is far from certain how the supreme court will approach the issue of preemption of state hmo liability laws. the court's discussion in rush, relating to the inappro­ priateness of preemption of laws regulating health care, could be viewed simply as dicta provided as further support for the majority's conclusion­ which became more important given the view of four dissenting justices that the ier law was impermissibly in conflict with erisa • s exclusive enforce­ ment scheme. the more prudent course in any erisa preemption action in which the validity of a state hmo law is at issue would be to formulate and articulate the full gamut of savings clause arguments. after rush and kahp, a law is saved from erisa preemption if it (1) constitutes a law specifically directed at the insurance industry and (2) sub­ stantially affects the risk pooling arrangement between the insurer and the insured. the crux of the analysis is a parsing of the who and the what of the regulation. laws are saved from preemption if they regulate entities in the insurance industry with respect to their insurance practices. 257. id. 258. see supra notes 41-43 and accompanying text 259. 215 ill comp. stat. ann. 125/1-2 (west 2003). the lllinois ffir law defines a health maintenance organization as "any organization formed under the laws of this or another state to provide or arrange for one or more health care plans under a system which causes any part of the risk of health care delivery to be borne by the organization or its providers." id. 2004] recent modifications to the preemption doctrine 1. are state hmo liability laws "specifically directed" at the insurance industry? 101 as noted, legislatively enacted state hmo liability laws typically impose the duty of care on health carriers260 or health insurance carriers,261 managed care entities, 262 hmos,263 or organized delivery systems.264 these terms are defined to reach entities with which an employer may contract to provide health coverage for its employees or to provide administrative services for employers that self-insure.265 both rush and kahp took a broad view of the who prong of the analysis and found it was satisfied if the laws primarily target entities which sufficiently engage in insurance activities. nonetheless, as explored in the following paragraphs, it is not clear whether state hmo liability laws will always pass the test. the court in rush specifically held that hmos sufficiently engage in insurance activities for the ier law to be specifically directed at the insurance industry, despite also engaging in non-insurance activities. according to the court, hmos engage in insurance activities because they assume financial risk and underwrite and spread risk among their participants. 266 further, the court in kahp specifically noted that hmos that provide solely administrative services for self-insured plans sufficiently engage in insurance activities to satisfy the test. similarly, the other entities often targeted by state hmo liability laws-for example, "managed care entities" or "organized delivery systems" -can readily be characterized as sufficiently engaging in insurance activities. although their structures may vary considerably, most mcos oper260. see wash. rev. code ann. § 48.43.545(1)(a) (west 2003); me. rev. stat. ann. tit. 24-a, § 4313 (l)(a) (west 2003); n.j. stat. ann.§ 2a:53a-33(a) (west 2003). 261. see tex. civ. prac. & rem. code ann. § 88.002(a) (vernon 2003); okla. stat. tit. 36, § 6593(a) (2003). 262. see tex. civ. prac. & rem. code ann. § 88.002(a) (vernon 2003); okla. stat. tit. 36,§ 6593(a) (2003); n.c. gen. stat. § 90-21.5l(a) (2001). 263. see tex. civ. prac. & rem. code ann. § 88.002(a) (vernon 2003); okla. stat. tit. 36, § 6593(a) (2003). 264. see n.j. stat. ann.§ 2a:53a-33(a) (west 2003). 265. wash. rev. code ann.§ 48.43.005(18) (west2003). for example, washington's hmo liability laws imposes the duty on health carriers and defines that term to include a "disability insurer, . . . a health care service contractor, . . . or a health maintenance organization." ld. see also tex. civ. prac. & rem. code ann.§ 88.001(8) (vernon 2003). the texas hmo liability law imposes the duty on, inter alia, "managed care entities" and defines that term to include: !d. [a]ny entity which delivers, administers, or assumes the risk for health care services, with systems or techniques to control or influence the quality, accessibility, utilization, or costs and prices of such services, to a defined enrollee population, but does not include an employer purchasing coverage or acting on behalf of its employees .... 266. rush prudential hmo, inc. v. moran, 536 u.s. 355, 365-66 (2002). see also supra notes 74-79 and accompanying text. 102 indiana health law review [vol. 1:51 ate comparably to hmos: they assume financial risk and underwrite and spread risk among their participants or provide administrative services for self­ insured plans.267 thus, if rush and kahp provide the only precedent. state hmo liability laws can readily be viewed as being specifically directed towards the insurance industry. however, as noted, rush and kahp did not address the reasoning articulated in pilot life for its determination that a common law bad faith breach of contract action was not specifically directed at the insurance indus­ try. in pilot life, the specific cause of action at issue was applicable only to those in the insurance industry; the state law cause action had evolved from general principles of tort and contract law, which. obviously, were not applicable only to insurers.268 this consideration was not relevant in rush and kahp because the cases involved state laws enacted by legislatures that did not simply evolve from pre-existing general principles. because the court in rush and kahp did not expressly or impliedly overrule this aspect of pilot life, it is logical to conclude that this reasoning still may be relevant to the inquiry. if so, this aspect of pilot life raises one of the harder savings clause issues related to state hmo liability laws. as to a common law, judicially recognized medical malpractice liability claim against an hmo, the better argument may be that pilot life precludes a finding that the law is specifically directed at the insurance industry. such a cause of action represents an evolu­ tion of basic tort law to newly emerging conduct that constitutes an exercise of medical judgment. the analysis is less clear as to legislatively enacted state hmo liability laws. for example, at least one lower court has recently held that a state statute authorizing a civil action for bad faith breach of an insurance contract. which expressly limits the action to the insurance context, is distinguishable from the law in pilot life and is fairly characterized as being specifically directed towards the insurance industry. 269 this court. however, still found the statute preempted based on other savings clause standards. 270 thus, although it is unclear whether the emphasis in rush and kahp on the who of regulation diminishes pilot life's specifically directed rationale, this factor nonetheless may be satisfied as to a legislatively enacted hmo liability law. 267. see, e.g., vickie yates brown & barbara reid harting, managed care at the crossroads: can managed care organiujiions survive government regulation?, 7 annals healthl. 25,27-29 (1998) (describing various fot'lm of managed care organizations). 268. see supra notes 124-26 and accompanying text 269. see, e.g., bell v. unum provident corp., 222 f. supp. 2d 692, 696-97 (b.d. pa. 2002) (discussing recent cases and concluding that, under the common sense test pennsylvania's bad faith statute "regulates insurance" because it is applicable only to insurers in actions arising under an insurance policy and is never applied outside the insurance industry). 270. ld. 2004] recent modifications to the preemption doctrine 103 2. the laws substantially affect the risk pooling arrangement in kahp, justice scalia wrote that to be saved from preemption, a state law must also substantially affect the risk pooling arrangement between the insurer and the insured.271 although the meaning of justice scalia's tenninology is not entirely clear, it is arguable that the test broadly encompasses any state law which has a substantial (or important) effect on any health coverage product offered by a health coverage provider. 272 a state law which allows injured subscribers to bring a civil action for damages arising from an hmo' s negligent medical necessity determination would seem to satisfy this test. state hmo liability laws do not directly affect the product offered by health coverage providers-that is, the policy or health coverage itself. however, they arguably produce an indirect effect. if hmos can be held accountable for coverage decisions that constitute medical decisions and held liable for monetary damages for a breach of a tort duty of care, it is reasonable to conclude that hmos will use some greater care in the ur process; thereby resulting in an improved health coverage product additionally, since most insurers strive to make a profit by maintaining predictable and stable levels of risk and by setting premiums at a level tailored to ensure a reasonable profit, 273 it is reasonable to conclude -that a law allowing liability for negligent ur decisions will impact the underwriting and premium setting process. thus, state hmo liability laws arguably have an important effect on the product offered by health coverage providers. the unknown is whether the above described effects are sufficiently substantial to satisfy justice scalia's new test. language in other relevant supreme court precedent perhaps sheds light on this question. in royal drug, the court noted that congress wanted to preserve state law regulation of insurance because it was concerned with "[t]he relationship between insurer and insured, the type of policy which could be issued, [and] its reliability, interpretation, and enforcement.'m4 although the court in kahp made a clean break: from the mccarran-ferguson factors developed in royal drug, kahp does not suggest that the court's general statements in royal drug about laws regulating insurance law are no longer relevant. rather, because the court in both rush and kahp broadened the scope of the savings clause, it is reasonable to conclude that the court's general language regarding laws regulating insurance (even if made in the context of the narrow antitrust exemption) is still relevant. thus, if the effect of a state law is to enhance the reliability of coverage decisions or the interpretive process used by a health coverage provider or to strengthen a subscriber's ability to enforce promises 271. see supra notes 118-19 and accompanying text. 272. see supra notes 128-38 and accompanying text. 273. see supra notes 129-36 and accompanying text. 274. see supra notes 107-13 and accompanying text. 104 indiana health law review [vol. 1:51 made in the health coverage policy, the effect readily seems sufficiently substantial to fall within the scope of justice scalia's test. a state hmo liability law has two important effects. such a law may well make it more likely that an hmo or mco will promptly approve cover­ age of recommended medical services that are arguably medically necessary. similarly, a state hmo liability law may enhance the ability of subscribers to deter negligent ur activity. thus, it is reasonable to argue that the law thereby enhances the reliability of coverage decisions and the interpretive process used by the health coverage provider and moreover, strengthens subscribers' ability to enforce the policy. the effect therefore readily seems sufficiently substantial to warrant exemption from preemption as a law regulating insurance, unless, of course, the law still falls within the conflict preemption exception to the savings clause. d. state hmo liability laws likely fall outside justice souter's carefully drawn conflict preemption exception as discussed in the foregoing sections, rush and kahp suggest that the court may determine that state hmo liability laws relate to erisa plans, but also constitute laws regulating insurance. as such, the conflict preemption principles may present the crux of the preemption analysis of state hmo liability laws-which is perhaps why justice souter took such care in narrow­ ing the role of conflict preemption in the erisa context. hmos will strongly urge the court to find that state hmo liability laws conflict with erisa's exclusive civil enforcement provisions by impermissibly providing an alterna­ tive cause of action with alternative remedies, thereby warranting preemption despite being characterized as a law regulating insurance. whether hmos are successful in this argument depends on whether five justices again agree with justice souter's more narrow view of the preemptive force of erisa § 502( a). as noted, some have construed rush as affirming the idea that erisa preempts state common law and legislative hmo liability laws.275 in the december 2002 article published in the american bar association's ("aba") publication, the health lawyer, the authors concluded that rush "would appear also to invalidate state [common law] and legislative attempts to create additional judicial rights and remedies for erisa participants under the rubric of 'insurance regulation. "'276 the authors then expressly opined that rush confirms the broad view of the preemptive force of erisa' s civil enforcement provisions, and that the preemptive force of pilot life would preclude state 275. see pimstone & johnson, supra note 20, at 7-9; see also humiston et al., supra note 19, at 7-8 (viewing rush as being consistent with the quality-quantity distinction that evolved from the concoran and dukes line of cases). 276. pimstone & johnson, supra note 20, at 8. 2004] recent modifications to the preemption doctrine 105 laws such as california's hmo liability law.277 that view of rush, however, is inconsistent with the majority's careful narrowing of the conflict preemption exception to the savings clause. the authors of the aba article seemed to focus only on justice souter's statements regarding state laws affording remedies, in a judicial forum, other than those specified in erisa;278 they failed to notice the integral accompanying statements clarifying cases, such as pilot life, involving plaintiffs using state laws to enforce claims that were actually available under erisa. 279 yet, justice souter's careful description of the key precedent, including pilot life, must be read as a whole. recall that the majority opinion in rush carefully confmed the scope of the conflict preemption exception in accordance with the contours of the key supreme court precedent. 280 read as a whole, justice souter's discussion stressed that, in each earlier case, the state law at issue provided a vehicle for a claimant to pursue, in a judicial forum, a claim that was, in essence, actually available under erisa (claims for breach of the duty to pay benefits due and a claim for discrimination prohibited by erisa) and yet would have resulted in a remedy other than those specified in erisa.281 thus, in determining whether the conflict preemption exception is available, justice souter clarified that the focus is .not just on the remedy afforded by the state law but also depends on the claim, as well as the timing and forum of the relief provided by the state law. state hmo liability laws without question allow a remedy other than those specified by erisa § 502(a). for example, california civil code section 3428 provides that hmos shall be liable for "any and all harm" caused by the hmo' s violation of the duty imposed, and that damages recoverable for violation of the law include "the amount which will compensate for all detri277. /d. (noting that, inter alia, "rush affinns the continuing vitality and relevance of pilot life;" and "[t]he supreme court in rush underscored the 'overpowering federal policy of exclusivity in erisa's civil enforcement provisions."'). 278. ld. for example, the authors noted that the court in rush declared that, in considering whether the preemptive force of§ 502(a) warrants preemption, "a state provision regulating insurance will lose if it allows plan participants 'to obtain remedies ... that congress rejected in erisa."' /d. similarly, the authors noted: "a state law 'that provided a form of ultimate relief in a judicial forum that added to the judicial remedies provided by erisa, declared the rush court, would 'patently violate[]' erisa's policies and is preempted." /d. 279. ld. this oversight may be attributable to the fact that the authors' focus throughout most of the article was on continued preemption of state bad faith claims. pimstone & johnson, supra note 20, at 8. because bad faith claims are grounded in a duty imposed by contract law (and erisa imposes comparable duties to conform to the terms of the insurance policy governing the erisa plan), the argument that erisa preempts such state laws remains viable after rush. /d. however, the authors' conclusions went beyond state bad faith claims. /d. 280. see supra notes 158-69 and accompanying text 281. /d. 106 indiana heal'ih law review [vol. 1:51 ment proximately caused thereby .... "282 several supreme court cases have expressly held that erisa does not authorize compensatory damages.283 state hmo liability laws also provide a vehicle for a claimant to pursue that form of ''ultimate relief' in a judicial forum. in rush, the majority recog­ nized that any remedy available as a result of the ier law would be attainable only by way of a§ 502(a)(l)(b) action for benefits,due.284 that is, the ier law created a process through which an hmo subscriber attained a right to coverage of a claim for benefits but did not create a private right of action or a vehicle for accessing the ultimate remedy for violation of that right. unlike the ier law at issue in rush, state hmo liability laws create both a right to the remedy and a vehicle for accessing the remedy for violation of that right. as with the california law, the right created by state hmo liability laws is the right to have limos use ordinary care in making medical necessity deter­ minations. 285 also, the vehicle for accessing the remedy of compensatory damages is a cause of action or a civil action in a judicial forum. moreover, many state hmo liability laws specifically provide that, subject to certain exceptions, the cause of action cannot be maintained until the claimant has exhausted all required internal and external review of the medical necessity determination, 286 thereby further indicating that the remedy is a form of ultimate relief. however, state hmo liability laws do not satisfy one key requirement stressed by justice souter for application of the conflict preemption exception. the claim created by state hmo liability laws is not a claim that is, in essence, available under erisa. in rush, justice souter carefully pointed out that the key supreme court precedent involved claims that were grounded in duties imposed by erisa. 287 in russell and pilot life, the plaintiffs sought benefits due under the insurance policies at issue; the plaintiffs' claims therefore predominantly were grounded in breach of erisa's directive to pay claims due under the terms of an erisa plan.288 in ingersoll-rand, the plaintiff's claim was grounded in conduct that constituted 282. see cal. civ. code§ 3428(a), (j) (west 2003); see also id.§ 3333. 283. see rush prudential hmo, inc. v. moran, 536 u.s. 355, 378 (2002) (describing the court's holdings in metropolitan life, russell, and pilot life). 284. /d. at 379-80. 285. see supra note 216 and accompanying text. 286. see, e.g., cal. cn. code§ 3428(k)(1). a person may not maintain a cause of action pursuant to this section against any entity required to comply with any independent medical review system or independent review system required by law unless the person or his or her representative has exhausted the procedures provided by the applicable independent review system id. exceptions exist for cases where substantial harm has or will occur prior to completion of the review. see id. § 3428(k)(2)(a)-(b). 287. see supra notes 158-69 and accompanying text. 288. see rush, 536 u.s. at 378-80. 2004] recent modifications to the preemption doctrlne 107 a violation of erisa's directive prohibiting discrimination in relation to employment benefits.289 in contrast, the state hmo liability laws do not create a claim that is grounded in a duty imposed by erisa. state hmo liability laws impose on hmos a tort duty to use reasonable (or ordinary) care when making medical necessity determinations.290 to conclude that the hmo liability tort duty is not, in essence, imposed by erisa, the supreme court's determination in pegram becomes relevant. as explained, the court in pegram held that, even if made by an hmo serving as an erisa plan administrator, ur decisions based on medical necessity determinations constitute mixed eligibility and treatment decisions and thus are not "administration of the plan" as that phrase is used in erisa. 291 rather, such decisions constitute the exercise of medical judgment. moreover, the court explained that state law, not erisa, regulates the exercise of medical judgment.292 thus, because erisa imposes no duty or directive comparable to the duty imposed by state hmo liability laws, the claim or cause of action created by state hmo liability laws is not grounded in duties imposed by erisa and thus is not a claim that is, in essence, available under erisa. in sum, although state hmo liability laws create a vehicle for accessing, in a judicial forum, a form of ultimate remedy that is not available under erisa, saving the law from preemption does not impermissibly conflict with erisa's civil enforcement provisions. because erisa imposes no duty or directive comparable to the duty imposed by state hmo liability laws, the claim or cause of action created by state hmo liability laws is not a claim that is, in essence, available under erisa. therefore, according to the carefully drawn lines in the majority opinion in rush, state hmo liability laws are outside the scope of the conflict preemption exception, thereby allowing the laws to be saved from preemption as laws regulating insurance. vi. conclusion continuing the trend begun in 1995 in travelers, the supreme court in rush and kahp has added significantly to the doctrinal aspects of erisa preemption and, more specifically, to the doctrinal aspects of erisa' s savings clause. as detailed in this article, the reworked basic savings clause standards should result in lower courts more readily finding state managed care reform laws to be within the scope of erisa' s savings clause, thereby strengthening the role of states in regulating activities and strategies of hmos and other managed care entities. indeed, because of the court's rejection of the conflict 289. ingersoll-rand co. v. mcclendon, 498 u.s. 133, 142-43 (1990). 290. see supra note 216 and accompanying text. 291. pegram v. herdrich, 530 u.s. 211, 229-30 (2000). see supra notes 240-49 and accom­ panying text. 292. pegram, 530 u.s. at 248-29. 108 indiana health law review (vol. 1:51 preemption principles beyond the preemptive force of erisa' s civil enforce­ ment provisions, and because the burden of such regulations was found to rest on the hmo or mco, not on the erisa plan itself, the cases suggest that states have a role in regulating hmos and mcos even as to activities and strategies that constitute administration of erisa plans. the court was unconcerned about the "disuniformity" affecting insured erisa plans operat­ ing in multiple states because that is simply the inevitable consequence of congress' decision to exempt from preemption state laws regulating insurance. some issues remain uncertain, of course. most notably, it is not absolute­ ly clear how the court would resolve the question whether erisa preempts emerging state hmo liability laws. overall, rush and kahp seem to support the emerging perspective that erisa does not preempt state hmo liability laws. however, the crux of the analysis may well hinge on application of conflict preemption principles and, specifically, on the court's view of the preemptive force oferisa's civil enforcement provisions. justice souter's opinion in rush, which was joined by a majority of the justices, seems to clear the way for state hmo liability laws by carefully describing the holdings in key cases in an effort to delimit the preemptive force of§ 502(a). this article has attempted to explain and emphasize the limitations detailed by justice souter. using justice souter's analysis, state hmo liability laws fall outside the scope of the preemptive force of § 502( a). ultimately, then, the key question is whether a majority of the court will again join in a narrow view of the preemptive force of erisa' s civil enforcement provisions. expanded hospital liability under the federal false claims act: an unexpected solution to the resident duty hour controversy robert r. elder • table of contents i. introduction ....................................................................................... 55 a. medical residents: why we need them and why they need sleep ......................................................................... 55 b. duty hour restrictions: attempts to reduce the risks posed by chronically sleep deprived medical residents ...................................................................... 56 c. a possible solution to an apparently irresolvable conflict ....................................................................................... 58 ll. the medical resident duty hour controversy ......................... 59 a. arguments made by proponents of traditional resident duty hours .................................................................. 59 1. the traditional view: no rest for weary residents ............. 59 2. the arguments made by proponents of resident duty hour reform ............................................................... 59 b. why duty hour restrictions are necessary for residents .......... 60 1. initial attempts at reform via regulation ............................. 61 2. the acgme's comprehensive approach to oversight: see no evil, hear no evil, and speak no evil ...................................................................... 62 c. acgme duty hour standard enforcement: why it doesn't work .................................................................. 64 1. a conglomerate of agencies: too many doctors jumping on the bed ............................................................. 64 2. acgme accreditation: a carrot and a stick ....................... 65 3. the greatest weakness: a lackofwhistleblower protection ............................................................................ 66 * j.d. candidate, 2008, indiana university school oflawindianapolis; m.b.a. can­ didate, 2008, indiana university kelley school ofbusiness; b.a., 1996, saint vincent college, latrobe, pennsylvania. i would like to thank mr. christopher campaniolo, j.d., executive notes editor of the indiana health law review, volume 4, whose friendship and encourage­ ment made the publication of this note possible. this note is dedicated to my wife, catherine, and my daughters, mackenzie and maggie, in the hope that the doctors who treat them will al­ ways be well rested. copyright 2008 by robert r. elder. 54 indiana health law review [vol. 5:53 d. state and federal legislative attempts to curtail duty hour violations ................................................................. 68 iii. making the grade: can graduate medical education withstand the assault of actions brought pursuant to federal the false claims act? ........................................... 71 a. the importance of main & chapman ......................................... 71 b. the false claims act generally ................................................. 71 1. the applicability of the false claims act ............................. 71 2. persons amenable to suit under the false claims act ........................................................................................ 72 3. knowing action under the false claims act ....................... 74 4. bringing a claim pursuant to the false claims act: the qui tam suit ................................................................. 74 5. damage liability under the false claims act ..................... 75 6. whistleblower protections under the false claims act ........................................................................................ 76 a. protection and relief for whistleblowers: employers beware ........................................................................... 76 b. federal jurisdiction: retaliatory discharge and whistleblower actions ................................................... 77 c. whistleblower actions: essential elements and limitations ..................................................................... 77 c. government funding of graduate medical education: the essential link ............................................................................. 78 d. the false claims act: expanding applicability ......................... 79 1. one lie begets another: the chain of causation grows longer ........................................................................ 79 2. a chain attenuated does not break: reaping what you sow ................................................................................ 80 iv. expanded liabiliit under the false claims act: in the wake of main and chapman ............................................. 82 a. expanded liability of universities generally: why hospitals should take note ....................................................... 82 b. the expanded liability of hospitals with federally funded graduate medical education programs ....................... 83 1. hospital liability under the false claims act: a statute reinterpreted ........................................................ 83 2. whistleblower protections for sleepy residents: a dream come true ............................................................ 84 v. conclusion .......................................................................................... 85 2008] expanded hospital liabll..lty under the federal fca 55 i. introduction a. medical residents: why we need them and why they need sleep american doctors are born in premedical undergraduate programs, evolve to intellectual adolescence in the crucibles of postgraduate medical schools, and achieve mature self-sufficiency through clinical practice in hospital-based med­ ical residency programs. the relationship between hospitals and medical schools is not, however, as one sided as this simplistic theorem of physician development appears to suggest. rather, their relationship is a symbiotic one. medical schools need the endless array of experiential opportunities available in public hospitals to provide medical students with hands-on practice, while public hospitals depend on the faculties of medical schools to educate and su­ pervise their medical residents ("residents").1 consequently, in a vast majority of america's public hospitals residents perform most of the on call, emer­ gency, and neo-natal patient care services.2 residents have similar duties in most private hospitals. 3 it is not hyperbole, therefore, to suggest that residents constitute the "lifeblood of most [american hospitals].',.. ironically, however, a hospital's reliance on the unique services rendered by residents may place the very patients they serve at increased risk. indeed, it must not be forgotten that residents are students. as such, they are typically inexperienced and less qualified than more seasoned medical professionals to perform the complex and often life sustaining medical services residents rou­ tinely render. furthermore, residents, unlike more experienced doctors, are still attempting to "master, both in theory and in application, the subtle intrica­ cies of human medicine and patient care.'.s moreover, residents are typically required to work grueling schedules that often result in persistent sleep depriva­ tion and fatigue. 6 a medical system that is overly reliant on residents, to pro1. w. paige hren, note, is it the end of an era or the beginning of an error? the american medico/ association finally approves work hour limits for overworked and sleep deprived medical residents: should osha still step in?, 23 j. nat'lass'n admin. l. judges 457, 461 (2003) ("medical schools need the public hospitals as sites to educate their medical students, and public hospitals need the faculty of medical schools for the education and supervi­ sion of their residents." (quoting stewart r. reuter, professional liability in postgraduate med­ ical education: who is liable for resident negligence?, 15 j. legal mel>. 485,485 (1994))). 2. id. at 461-62 ("[i]n most of america's public hospitals, 'residents assume the bnmt of 'on call' patient care services.'" (quoting reuter, supra note i, at 517)). 3. id. at 462 ("it is also quite common to find residents practicing and learning in pri­ vate hospitals as well."); cf. reuter. supra note 1, at 517 ("(l]n private hospitals ... senior resi­ dents provide most of the care at night, supervised by the patient's physician on call by telephone."). 4. hren, supra note 1, at 461 ("residents and residency programs are the life blood of most public hospitals in america."). 5. id. at 458. 6. dori page antonetti, note, a dose of their own medicine: why the federal gov­ ernment must ensure healthy working conditions for medical residents and how reform 56 indiana health law review [vol. 5:53 vide patient care, creates obvious risks. indeed, less experienced chronically sleep deprived residents may administer inappropriate or inadequate medical services that may result in patient injury or death. to minimize the risks posed by resident inexperience, the solution is ob­ vious if not entirely palatable: residents must learn, and to learn they must practice under the guidance of their more experienced peers in the unique envi­ ronment afforded by america's hospitals. consequently, the risks posed by resident inexperience must be balanced against the nation's need to constantly replenish the supply of highly skilled doctors. thus, one might argue that the reliance of hospitals on inexperienced residents is unavoidable and, given proper oversight protocols, excusable. a system that promotes chronic sleep deprivation among residents, however, is not as easily excused. such a system is especially problematic when residents are expected to serve as the vanguard of patient care in america's hospitals. b. duty hour restrictions: attempts to reduce the risks posed by chroni­ cally sleep deprived medical residents there have been attempts to improve patient safety by restricting the duty hours of residents. these attempts, however, have only been marginally suc­ cessful. this is due in part to the entrenched medical establishment which firm­ ly opposes any external regulation of medical education.' ironically, reformers' attempts to change resident duty hours have most often been thwarted by well­ meaning medical educators' intent on preserving the sanctity of the age-old master apprentice educational model.8 indeed, lacking what they consider firm "empirical evidence" physicians, teaching in hospitals with residency programs, simply refuse to give up their control over the hours worked by residents.9 as a result, a variety of special interest groups petitioned the federal government to should be accomplished, 51 cam u. l. rev. 875, 876 (2002) ("[f]atigue [is] a condition pre­ vfl.).ent among physicians-in-training who commonly work sixty to one hldldred and thirty hours per week, with ldlinterrupted shifts of thirty-six hours or more." (citing heal til res. group, public cmzen, publ 'n no. 1570, pennon to tile occupational safety and healtii administration requesting tiiat ljmrrs be placed on hours worked by medical residents (2001), www.citizen.org/publicationslprint_release.cfin?id=6771 [hereinafter petition to osha] (last visited apr. 9, 2008)). 7. jennifer f. whetsell, changing the law, changing the culture: rethinking the "sleepy resident" problem, 12 annals heal till. 23, 63 (2003) (''some doctors ... vowed not to honor regulations from the beginning, purportedly believing in their hearts that the changes would lead to detrimental effects on patients, including lost information from the discontinuity in care provided to those patients.j. 8. id. at 63 ("[resident] work: hours are what healthcare provider institutions object to most voraciously; they still adhere to the master-apprentice model and thus favor the notion of adequate supervision, at least in theory, if not in practice.j. 9. id. at 64 ("[p]hysicians exercise a great deal of control over healthcare delivery and they simply do not want to be told what to do, particularly in the absence of what they deem solid empirical findings that contradict their healthcare philosophy."). 2008] expanded hospital liabjlity under tiie federal fca 57 impose resident duty hour regulations through the agency of the occupational safety and health administration ("osha.,).10 proponents of resident duty hour reform believe that federal oversight would improve resident working conditions for two reasons: first, federal oversight would dilute the absolute authority that medical educators and hospi­ tal administrators wield over residents. second, direct federal oversight could provide whistleblower protections that would encourage residents to report duty hour violations themselves. to date, however, osha has formally de­ clined to impose federal oversight over resident duty hour limitations, choos­ ing instead to adopt standards drafted by the accreditation counsel for graduate medical education ("acgme.,).11 although well intentioned, the acgme restrictions on resident duty hours have been only marginally successful in curtailing the medical commu­ nity•s habit of requiring residents to work dangerously long duty hours. 12 the limited success of the acgme is partially due to the intimate relationship be­ tween teaching hospitals and the acgme. unlike osha, the acgme is a private regulatory agency composed of special interest groups from the medical community. 13 as a result, the acgme mainly consists of career medical pro­ fessionals and educators intent on preserving the status quo. thus, its supervi­ sory role not withstanding, the acgme has proven itself a force to be reckoned with when attempting to reform the practice of medicine in the united states.14 furthermore, the acgme has a very clear interest in preserving its control over graduate medical education ("gme,.) because it acts as the sole agency responsible for certifying and accrediting all medical programs in the united states. not surprisingly, therefore, any mention of whistleblowerprotections is 10. petition to osha, supra note 6. 11. michael j. frank, safeguarding the consciences of hospitals and health care per­ sonnel: how the graduate medical education guidelines demonstrate a continued need for protective jurisprudence and legislation, 41 st. louis u. lj. 311, 321 (1996) the acgme operates as an unincorporated, 'nonprofit, private association which surveys. evaluates and accredits medical and surgical residency pro­ grams throughout the united states.' however, its status as a private insti­ tution is somewhat attenuated by the fact that the federal and state governments rely on the acgme 's evaluation of residency programs to de­ termine whether a hospital dierits public funding. (quoting interfaith med. ctr. v. sabiston. 527 n.y.s.2d 48,49 (n.y. app. div. 1988)); see, e.g., changes in payment policy for direct graduate medical education costs, 54 fed. reg. 40,286 (sept. 29,1989) (to be codified at 12 c.f.r. pt. 405, 412-13). 12. robert neil wilkey, federal whistleblower protection: a means to enforcing max­ imum-hour legislation for medical residents, 30 wm. mitchell l. rev. 331, 342 (2003) ("despite the breath and thoroughness of these standards substantial evidence suggests that the acgme has failed to effectively enforce such measures."). 13. ld. 14. laura lin & bryan a liang, reforming residency: modernizing resident education and training to promote quality and safety in healthcare, 38 j.healrnl. 203, 208-09 (2005) (citing accreditation council for glw>uatemed. educ., theroleof1heacgme (2007), http://www.acgme.orglacwebsite/about/ab _ roleacgme.asp [hereinafter the role] (last visited apr. 9, 2008)). 58 indiana health law review [vol. 5:53 conspicuously absent from the acgme duty hour standards. as a result, the standards are seen as weak and ineffectual and residents have little motivation to report violations of the standards.15 consequently, many residents who are required to work duty hours, in violation of the guidelines imposed by the acgme, are unwilling to blow the whistle on their employers. c. a possible solution to an apparently irresolvable conflict in response to the ineffectual nature of acgme oversight and the contin­ ued prevalence of resident duty hour violations, members of the federal legisla­ ture backed by prominent groups such as the american medical student association ("amsa'') have attempted to pass legislation that federalizing oversight ofhospital duty hours.16 other legislation efforts have sought to pro­ vide the whistleblower protections necessary to ensure compliance with the du­ ty hour limitations ostensibly imposed by the acgme.17 unfortunately, all such legislation has stalled in committee.18 recent rulings in the seventh and ninth circuits, regarding the applicability of the false claims act ("fca''}, to federally funded institutions, however, may make future legislation unneces­ sary. indeed, it is the contention of this note that the ruling of the court in united states ex rei. main v. oakland city university, 19 as interpreted and ex­ panded by the court in united states v. chapman university, 20 has provided proponents of resident duty hour reform with the legal tools necessary to en­ sure hospital compliance with the current acgme duty hour standards. 15. wilkey, supra note 12, at 343 ("(t]be acgme guidelines are perceived by practitioners as 'weak, voluntary, and different for each specialty' .... [t]bus, the very culture of the medical profession promulgates a perception of the standards as superficial, amendable, and rarely enforceable.") (quoting sidney m. wolfe, public citizen petitions to osha to limit residents' working hours, health letter, june 1, 2001, http://www.citizen.org/publications/ release.cfin?id=7222 (discussing work hour limits for residents under acgme) (last visited apr. 9, 2008)). 16. whetsell, supra note 7, at 57. 17. ld. see, e.g., h.r. 3236, l07th cong. §3(c)(2001). 18. whetsell, supra note 7, at 58 (quoting damon adams, push to improve patient sqfety slowgoing, am. med. news, may 7, 2001, at 1). 19. united states ex rei. main v. oakland city univ., 426 f.3d 914, 916 (7th cir. 2005), cert. denied, 126 s.ct. 1786 (2006). 20. united states v. chapman univ., no. sacv 04-1256nsrcx, 2006 wl 1562231, at *2 (9th cir. may 23, 2006). 2008] expanded hospital liability under tile federal fca 59 ll. the medical resident ou1y hour controversy a. arguments made by proponents of traditional resident duty hours 1. the traditional view: norestfor weary residents traditionally, medical practitioners and hospital hierarchies have argued that residents must work grueling hours. indeed, proponents assert that such a work schedule is necessary to ensure that residents observe and participate in all aspects of their patients' illness, treatment, and recovery.21 furthermore, these opponents also point out that grueling duty schedules permit residents to remain with a patient throughout the patient's stay in the hospital; thereby, avoiding potentially catastrophic gaps in treatment and demonstrating an ade­ quate standard of care. 22 2. the arguments made by proponents of resident duty hour reform conversely, proponents of duty hour reform argue that the long duty hours imposed upon residents are counterproductive. proponents typically propose two arguments in favor of reform: first, they assert that working such long hours is likely to result in sleep deprivation that hinders the learning process and is ultimately counterproductive to the broader goals of gme.23 second, proponents argue that residents who are required to work ridiculously long hours are unlikely to provide care sufficient to meet patients' needs, a deficit likely to place both residents and patients at increased risk. 24 to support these arguments, proponents cite studies reporting that residents working long hours frequently suffer from depression and fatigue conditions known to increase in­ cidents of resident error resulting in personal and patient injury.25 during the 1990's medical studies and improvements in resident moni­ toring techniques made it easier for governmental agencies to link iatrogenic 21. lindsay evans, note, regulatory and legislative attempts at limiting medical resi­ dent work hours, 23 j. legalmed. 251,252 (2002) ("(l]ong hours are essential to medical education in that proper training requires residents to observe a condition from beginning to end, whenever possible." (citing davida asch & ruth m. parker, the libby zion case: one step forward or two steps backward?, 318 new eng. j. med. 771,774 (1988))). 22. /d. at 252 ("[ a]n adequate standard of care requires a resident to stay with his or her patient for the duration of the visit in an effort to preclude dangerous gaps in care and/or infor­ mation created by frequent shift changes. j. 23. hren, supra note 1, at 459 ("[t]he long hours and resulting sleep deprivation endured by residents are counter productive to the learning process and actually hinder the educational goals of residency training programs."). 24. /d. ("[n]ot only do the long hours prevent residents from providing adequate patient care, they also pose serious health and safety risks to residents and patients alike."). 25. see, e.g •• petition to osha. supra note 6. 60 indiana health law review [vol. 5:53 injuries to fatigued resident care givers, a link long suspected by the public. 26 this increased awareness sparked a revolution in public thought and action, a revolution that persists to this day. as a result, elected officials, patient advo­ cacy groups, and several prominent medical professionals have begun to chal­ lenge the authority traditionally accorded teaching physicians and hospital managers who seek to downplay or justify the risks posed by overworked resi­ dents. b. why duty hour restrictions are necessary for residents inarguably, members of the amsa are uniquely qualified to offer insight into the risks created by unreasonable resident duty hours. the position taken by the amsa is clear: chronic sleep deprivation unnecessarily increases the risk that residents will make potentially life threatening medical errors. 27 in 2004, the new england journal of medicine published statistical support for this position in a study that compared the effects of traditional long duty hour and non-traditional short duty hour resident work schedules.28 the study conclusively demonstrated that interns and residents working on a traditional schedule exhibited an "increased incidence of attentional fail­ ures [sufficient to] ... impede their ability to care for patients . . .. " 29 interns working traditional extended shifts were thirty-six percent more likely to make serious medical errors than were those students working shorter shifts.30 resi­ dents were also routinely required to remain long after the termination of their shift simply because hospitals habitually failed to ensure that other qualified caregivers would be available for relief, a situation that only aggravated the ef­ fects of sleep deprivation.31 finally, scheduling issues aside, the study con­ cluded that nearly a quarter of all residents might, by natural disposition, be uniquely susceptible to the deleterious effects of chronic sleep deprivation.32 clearly, the intuition of the amsa was correct. reform in resident's duty 26. thomas r. mclean, the 80-hour work week: why safer patient care will mean more health care is provided by physician extenders, 26 j. legal med. 339, 346 (2005) ("during the 1990's, as the public increasingly became empowered to challenge the authority traditionally accorded physicians, governmental agencies found it easier to link iatrogenic inju­ ries to fatigued health care providers."). 27. press release, kim becker, dir. ofpub. relations, am. med. student ass'n, new england journal reports medical errors relat [sic] to work hours: validates amsa's call for federal regulations (oct. 27, 2004}, http://www.amsa.orglnews/release2.cfx?id= 190 [hereinaf­ ter ama reports errors] (last visited apr. 9, 2008). 28. see generally steven w. lockley et al., effect of reducing interns· weekly work hoursonsleepandattentionalfailures, 351 new eng. j. med. 1829, 1829-33 (2004)(exam­ ining the differential impact of long and short duty hour rotations on residents and provides empirical support for the amsa's assertion that long duty hours lead to reduced resident effi­ ciency and reliability.). 29. /d. at 1835. 30. ama reports errors, supra note 27. 31. lockley et al., supra note 28, at 1836. 32. ld. 2008) expanded hospital liabillty under the federal fca 61 hour requirements is necessary to promote the safety and well being of resi­ dents and patients alike. i. initial attempts at reform via regulation recognizing that hospitals with medical residency programs typically demonstrate a stubborn unwillingness to voluntarily reduce resident duty hours, proponents of resident duty hour reform initially approached the ameri­ can medical association ("ama'') and the acgme for assistance.33 these organizations, however, were also initially unwilling to address the issue of resident duty hour restrictions. consequently, in 2001, proponents ofresident work hour reform sought federal intervention by asking osha to address the issue. 34 ironically, the threat of possible federal oversight sparked a flurry of private regulatory action on the part ofboth the ama and a come. 35 thus, in june 2002, "for the first time in history" the ama adopted policy guidelines aimed at changing the working conditions of medical residents. 36 shortly the­ reafter, the a come followed suit by creating resident duty hour guidelines mirroring those outlined by the ama?7 ultimately, osha declined to adopt a direct role in the creation of resi­ dent duty hour guidelines, opting instead to ''rely on the work hour guidelines and enforcement processes recently drafted by the acgme.'.38 osha ration­ alized its decision to rely on the acgme's resident work hour guidelines stat­ ing that "resident work hour issues would be better addressed by entities with experience both in patient care and employee health. thus, because the a come has extensive experience in patient health, employee health, and med­ ical education and training ... the a come was in a better position to address the issue .... '.39 consequently, in 2003 the a come became the primary regu­ lator of resident duty hour reform in american hospitals.40 33. see generally hren, supra note 1, at 459 ("optimistic about future reform, proponents more recently shifted their focus on soliciting various regulatory agencies capable of enacting and enforcing resident work hour limitations.''). 34. ld. see, e.g., petmon to osha. supra note 6. 35. hren, supra note 1, at 460 (noting that after osha chose to adopt the guidelines promulgated by acgme "the ama. stating that resident work conditions are best addressed 'without regulation by agencies of the government,' announced that it too would rely on the guidelines set by the acgme."). 36. id. at 459 ("[f)or the first time in history, the american medical association (ama) adopted new policy guidelines detailing specific definitions, hours, and working conditions for medical residents.''). 37. ld. 38. id. at 460. see, e.g., letter from john l. henshaw, assistant sec'y for occupational safety & health, u.s. dep't of labor, to sydney m. wolfe, dir., health res. group (oct. 4, 2002), available at http://www.citizen.org/documents/acfc2b.pdf [hereinafter letter). 39. hren, supra note 1, at 467 (internal citations omitted). 40. ld. at 460 ("in february 2003, the acgme's final standards were approved and be­ came effective for all accredited united states residency programs on july 1, 2003.'') 62 indiana health law review [vol. 5:53 2. the acgme's comprehensive approach to oversight: see no evil, hear no evil, and speak no evil the acgme was relatively slow in adopting a comprehensive approach to limiting resident duty hours. indeed, by the time the acgme adopted its duty hour standards "[a] number of other nations, including the united king­ dom, most other european nations, canada and australia [had already] limited hours for physicians in training by government regulation . . . .'.41 the a come's slow response notwithstanding, however, its adoption of regulatory standards did constitute a grudging acknowledgment of the considerable body of scientific evidence demonstrating conclusively that "long hours and sleep loss have a negative effect on resident performance, learning and well-being.'.42 even so, the a come's regulatory response, a response that imposed duty hour standards rather than restrictions, hardly constituted a polar shift in its ap­ proach to the resident duty hour controversy. moreover, the scheme employed by the acgme to ensure hospital compliance with the standards has proven problematic. as a private regulatory agency responsible for the accreditation and over­ sight of more than 7,800 medical programs the "a come relies on twenty-six specialty specific residency review committees (rrcs) to develop its accredi­ tation standards and to review resident programs for compliance with acgme standards. '.43 the acgme attempts to ensure tliat hospitals employing medical residents provide high quality medical care by monitoring the educational qual­ ity of residency programs and the work environment to which residents are exposed.44 in its current form, the comprehensive approach to regulating resident duty hours adopted by the acgme seeks to place suitable limits on those duty hours, increase institutional oversight of residency programs, and promote edu­ cational practices that enhance patient care.45 in general, the regulations limit resident duty hours to eighty per week. 46 more specifically, in any eighty-hour 41. accreditationcouncu.forglw>uatbmed. educ., tlmacgme'sappr.oachto limit resident dury hours: tim common standards and aci1vities to promote adherence 1, available at http://www.acgme.orglacwebsite/dutyhours/dh_dhsummary.pdf [hereinafter common standards]. 42. id. 43. lin & liang, supra note 14, at 208-09 ("rrc members are appointed by the ameri­ can medical association (ama), the member board of the american board ofmedical special­ ties, and in many specialties the academic specialty organization. j. 44. see interfaith med. ctr. v. sabiston, 527 n.y.s.2d 48, 49 (n.y. app. div. 1988), vacated in part, 143 a.d.2d 173 (n.y. app. div. 1988). see also lin & liang, supra note 14, at 209 (''on average, hospitals have site visits every four yeats. and if programs meet the acgme criteria, they may be accredited for up to five years."). 45. common standards, supra note 41, at 1. 46. accreditation council for graduate mild. educ., acgme highlights its standards on resident dury hours (2001), http://www.acgme.orglacwebsite/reslnfo/ ri _ osharesp.asp (last visited apr. 9, 2008). 2008] expanded hospital liabllity under tile federal fca 63 work week, no more than twenty-four continuous duty hours may occur back to back, rest periods between duty shifts must be provided, an in-house call must be scheduled no more frequently than every third night, and one day in seven must be free of program responsibilities. 47 these regulations are not, however, inviolable. indeed, as stated above, they are not restrictions. rather, they are flexible standards permitting residents to exceed the suggested number of weekly duty hours if doing so will enhance their education.48 logically, the unique nature of a resident's educational experience and the unpredictable na­ ture of medicine require the inclusion of this exception. its inclusion, however, provides hospitals and supervising physicians with the requisite means, oppor­ tunity, and rationale to circumvent the spirit of the acgme standards at will. in recognition of the obvious loophole in the a come regulations, the a come seeks to promote enhanced adherence to its resident duty hour stan­ dards by requiring rrcs to routinely collect and monitor resident duty hour scheduling information from accredited hospitals.49 specifically, rrc's are required, through inspections and interviews with residents, to measure compli­ ance with resident duty hour standards. 50 moreover, the a come has also es­ tablished a formal process . for investigating allegations of program non­ compliance filed by residents and others with knowledge .of purported resi­ dent duty hour scheduling violations. 51 to ensure the efficacy of its oversight regime, rrcs are themselves sub­ ject to various oversight mechanisms. 52 thus, in theory, rrcs possess the cre­ dibility and power necessary to monitor residency programs, and may issue citations to any programs that fail to substantially comply with its stated stan­ dards. 53 moreover, if an accredited residency program fails to comply with the resident duty hour standards after receiving such a citation, the rrcs are per­ mitted to terminate the program's a come accreditation. 54 in practice, how­ ever, both the regulatory powers of the rrcs and the draconian enforcement mechanisms at their disposal appear to amount to little more than smoke and mirrors. indeed, despite the fact that residents continue to report working un47. id. 48. !d. ("[t)he standards provide for an increase of up to 10 percent beyond the so-hour weekly limit.''). 49. /d. 50. lin & liang, supra note 14, at 235 ("acgme measures compliance with these standards through on site [sic] inspections, including interviews with residents.'') (citing accreditation councr.for graduate mel>. educ., 'lim accreditation process and the role of the acgme site visitor (2007), http://www.acgme.org/acwebsitelfieldstafl7 fs_siterole.asp (last visited apr. 9, 2008)). 51. commonstandards,supranote41, at 1-2. 52. !d. 53. lin & liang, supra note 14, at 235 ("acgme also issues citations and monitors delinquent programs for 'substantial compliance' with its guidelines." 54. ann pomeroy, medical school council urges limits on residents, hours-hrnews­ accreditation council for gradual~ medical education, hr. magazine, apr. 2003, at 34 ("re­ sidency programs that fail to comply with the standards can be placed on probation or have their accreditation withdrawn. j. 64 indiana hea.lrn law review [vol. 5:53 reasonably long hours in violation of acgme standards, no institution has ever been relieved even temporarily of its acgme accreditation. 55 thus, given that rrcs have not used the tools at their disposal to eliminate resident duty hour abuses, the strength of the acgme's standards themselves must be called into question. c. acgme duty hour standard enforcement: why it doesn't work there is ample evidence to suggest that the acgme's oversight and en­ forcement of resident duty hour regulations is largely ineffective, notwith­ standing the "thoroughness" of these standards; 56 there are two reasons that the acgme's duty hour standards are not effectively enforced: first, the acgme has been substantially ineffective in enforcing the provisions of the regulations. second, the regulations do not provide residents with sufficient whistleblower protection to inspire widespread reporting of the duty hour viola­ tions to which they are routinely subjected. 1. a conglomerate of agencies: too many doctors jumping on the bed with regard to the issue of enforcement, advocates of resident duty hour reform unilaterally assert that medical practitioners consider the a come duty hour standards weak and subject to voluntary compliance. 57 this widely held belief is supported by the perception that the standards are unevenly enforced across medical specialties, an enforcement issue rooted in the very organiza­ tional structure of the a come. 58 in its current form the acgme's oversight power is effectively diffused among the "american board of specialties, the american medical association, the american hospital association, the asso­ ciation of american medical colleges, and the council of medical specialty societies."59 consequently, even if the constituents of the acgme were moti­ vated·to curtail resident duty hour abuses, they would find it difficult, ifnot impossible, to act with the requisite unanimity of purpose to effectively regulate their own policies.60 55. wilkey, supra note 12, at 342-43 ("[p]ast experience demonstrates that the acgme rarely finds violations, and if it does, the likelihood tbat a medical resident program will lose accreditation is close to nil."). 56. /d. at 342. 57. /d. ("[1]he very culture of the medical profession promulgates a perception of the [acgme] standards as superficial, amendable. and rarely enforceable.j. 58. /d. 59. /d. at 342. 60. !d. ("[1]he oversight power of the a come is essentially diffused among the partici­ pating organizations. in fact, as one council member expressed. •the a come needs to act in a more independent manner ... the control of the parents inhibits the acgme from acting in areas [it] needs to act [sic]."' (quoting frank, supra note 11, at 322)). 2008] expand ed hospital liability under the federal fca 65 2. acgme accreditation: a carrot and a stick organizational diversity is not, however, the only weakness in the acgme's approach to enforcing resident duty hour standards. indeed, the necessity of maintaining acgme program accreditation also undermines the effectiveness of the acgme's primary oversight tool: resident self­ reporting.61 resident self-reporting presupposes that residents will actively report duty hour violations, and it is a key tool in the regulatory arsenal of the acgme. resident self-reporting has, however, proven to be an unreliable source of information, because residents are reluctant to provide the acgme with notice of duty hour violations. 62 the reluctance of residents to report a duty hour violation is rooted in the fact that medical residency programs require acgme certification in order to receive the medicare based gme funding on which they depend. 63 therefore, the loss of acgme accreditation would have the effect of virtually shutting down a hospital's residency program. moreover, in order to be eligible for medical board certification, residents must successfully complete an acgme accredited program.64 consequently, if a resident report had the effect of shutting down a residency program, the ca­ reers of every resident in the program would be put in jeopardy. clearly, gme program funding and board certification are directly related to and flow from acgme accreditation.65 not surprisingly, both residents and medical staff members usually refrain from reporting regulatory violations. indeed, even though residents "are fiduciaries to their patients"66 they are also directly "ac­ countable to their superiors for their future careers and would rather endure a few years of grueling working conditions than do anything which might com­ promise their careers.'o67 unfortunately, therefore, the possibility that resident self reporting might force a hospital to forfeit acgme accreditation and gme funding has done little to motivate change with regard to the resident duty hour issue. indeed, hospitals do not fear the loss of acgme accreditation since they know that 61. wilkey, supra note 12, at 342 ("[d]etennining violations based on self-reporting methods such as surveys or questionnaires is problematic because medical staff and residents are reluctant to report the hospitals where they work for fear that their programs would lose accredi­ tation."). 62. id. 63. lin & liang, supra note 14, at 235. 64. /d. at 208-09 ("more than ninety percent of u.s. medical school graduates participate in postgraduate residency training and seek certification. board certification significantly influ­ ences hospital privileges, peer and patient recognition, economic compensation, and the stan­ dard of care." (citing 1he role, supra note 14.)). 65. lin & liang, supra note 14, at 235 ("programs that lose accreditation are virtually shut down because programs must be acgme-accredited in order to receive medicare gme funding that supports new residents."). 66. sarah l. geiger, the ailing labor rights of medical residents: curable ill or a lost cause?, 8 u. pa. j. lab. & emp. l. 523, 540 (2006). 67. geiger, supra note 66, at 539. 66 indiana health law review [vol. 5:53 residents have little motivation to self-report duty hour violations; thus, hospi­ tals enforce resident duty hour standards at will, if at all. one might argue that hospitals in violation of the acgme standards should forfeit their accredited status simply because they continue to place residents and patients at risk. an obvious solution to the problem created by the reluctance ofresidents and oth­ er well-intentioned medical professionals to report duty hour violations would be to permit residents and others to file anonymous complaints regarding the violation of duty hour standards. the acgme, however, pointedly refuses either to consider anonymously filed complaints68 or to provide whistleblower protections to those who file formal complaints. 69 consequently, in spite of acgme resident duty hour standards, many chronically sleep-deprived resi­ dents continue to practice medicine in america's hospitals. 3. the greatest weakness: a lack ofwhistleblower protection in a very real sense, residents rely on the benevolence and professional acumen of their medical peers for career advancement 70 therefore, few resi­ dents are willing to complain to the acgme, or to anyone else, when they are required to work irrationally long hours because they fear retaliatory dis­ charge. 71 furthermore, those residents that do raise allegations of regulatory violation, in the hope of improving working conditions and enhancing the qual­ ity of care, risk having their programs terminated; thereby, inspiring the ire of their contemporaries and discrediting the academic reputations of the v~ insti­ tutions and superiors to which they are looking for career advancement 7 con­ sequently, "the question of ... whether or not whistleblower protections would result in more favorable working conditions for medical residents .... "is cen­ tral to the issue of duty hour enforcement 73 indeed, many observers believe that federal enforcement of resident duty hour limitations is necessary to en­ sure that hospitals with graduate medical programs comply with acgme reg­ ulations. 74 68. lin & liang, supra note 14, at 235 ("anonymous complaints are not considered by acgme, the complainant must provide [a] name and mailing address." (citingaccreditation council for graduate mel>. eouc.,acgmeproceduresaddressingcomplaintsagainst residency programs (2007), http://www.acgme.org/acwebsitelresinfo/ri_ complaintasp (last visited apr. 9, 2008)). 69. pomeroy, supra note 54, at 34 ("residents are beholden to their supervisors, and whistleblower protection is inadequate.''). 70. geiger, supra note 66, at 539. 71. wilkey, supra note 12, at 342 ("[d)etermining violations based on self-reporting methods such as surveys or questionnaires is problematic because medical staff and residents are reluctant to report the hospitals where they work for fear that their programs would lose accredi­ tation."). 72. pomeroy, supra note 54, at 34. 73. wilkey, supra note 12, at 346. 74. pomeroy. supra note 54, at 34 ("[the committee of interns and residents j believes that federal enforcement of work hour restrictions is necessary .... "). 2008) expanded hospital liabujty under the federal fca 67 the intimate relationship between retaliatory discharge and whistleblower protection is well documented in the united states. 75 moreover, whistleblower protections have been used to enforce labor statutes, laws, and legislative man­ dates, 76 and have also been routinely applied to individuals working in the healthcare industry. 77 thus, the fact that residents are constrained by custom and socioeconomic reality from raising allegations of hospital non-compliance with the a come duty hour regulations adopted by osha raises issues unique­ ly suited to the application of whistleblower protections. 78 proponents of resident duty hour limitations assert that whistleblower protections should be extended to residents because they are uniquely situated to determine when violations of a come duty hour limitations are occurring; 79 conversely, most "hospitals vehemently oppose extending whistleblower pro­ tection to medical residents.'.so hospital administrators and the ama have raised managerial concerns, arguing that providing residents such protections might increase pending litigation against their hospitals; thereby, reducing the hospital's ability to deliver effective health care, 81 and impeding the effective management of their organizations' internal affairs. 82 medical educators, on the other han~ are less concerned with the potential loss of managerial efficiency and more concerned about the potential loss of academic freedom. 83 they ar­ gue that extending whistleblower protections should remain a discretionary is­ sue. so that residency programs are not faced with the necessity of reducing educational efficiency so as to satisfy an arbitrary "maximum-hour regime. "84 75. wilkey, supra note 12, at 346 ("(w]ithin the united states, the relationship between whistleblower protection and retaliatory discharge is well documented."). 76. /d. ("the use ofwbistleblower protection as a means to enforce particular labor stat­ utes, laws, or legislative mandates is not new."). 77. /d. ("the application ofwbistleblower protection to health professionals is not a new concept either."). 78. /d. ("integral to the conceptual framework embodied in whistleblower protection is the probability that employers will retaliate against employees in the form ofbarassment, demo­ tion, or termination."). 79. see generally virginia u. collier et al, stress in medical residency: status quo qfter a decade of reform, 136 annals internalmed. 384, 384 (2002) (providing factual accounts of residents observing and experiencing violations of maximum-hour guidelines). 80. wilkey, supra note 12, at 352 (citing am. med. stijdent ass'n, resident work hour issue debate sheet 1 (2007), http://www.amsa.org/rwh/952debate.c:fm (suggesting that hospitals do not think that the extension ofwbistleblower protection will be an adequate incen­ tive for self-reporting among residents) (last visited apr. 9. 2008)). 81. /d. ("[t]here is concern that both physicians and patients may be deterred from dis­ closing specific information in reports, records, and charts in the fear that it may be subpoenaed at a future date." (citing statement for the record submitted by the american academy offam­ ily physicians, house comm., ways and means, subcommittee on health (sept. 10, 2002))). 82. /d. ("[o]rganizations such as the ama view the extension ofwbistleblower protec­ tion as an impediment to the management and internal affirirs ofhospitals."). 83. seeid. 84. /d. ("another concern with extending whistleblower protection is the issue of discre­ tion: medical residency programs have educational requirements that may necessitate time commitments that cannot be met under a maximum-hour regime.''). 68 indiana health law review [vol. 5:53 other critics simply contend that extending whistleblower protections to resi­ dents will exacerbate the systemic problems posed by ever-rising healthcare costs, growing malpractice insurance premiums, and shrinking education budg­ ets.85 thus, the resident duty hour regulations promulgated by the acgme and adopted by osha are neither widely accepted, nor adequately enforced by most influential participants in the american medical community. d. state and federal legislative attempts to curtail duty hour violations in stark contrast to the positions taken by hospital administrators, medical academics, and professional organizations like the ama, patients rights, groups, residents, and the amsa all support both the equitable enforcement of the acgme's duty hour regulations, and legislative efforts to enhance the effec­ tiveness of those regulations by providing residents with whistleblowerprotec­ tions. moreover, the apparent unwillingness and inability of medical professionals to establish and enforce reasonable duty hour standards has prompted many government actors to promulgate legislation aimed at ensuring hospital compliance with duty hour standards. the bell regulations constituted an initial attempt by a state government to reform the healthcare polices and duty hour standards of american hospi­ tals. 86 these regulations were established in 1998 by way of an amendment to the new york state health code, after a report revealed that residents were working dangerously long hours. 87 the bell regulations were similar in scope to the 2003 acgme standards in that they attempted to impose explicit limits on the number of hours residents were permitted to work.88 unfortunately, they also met with similar difficulties. 89 the bell regulations lack of whistle­ blower protections notwithstanding, they also failed to consider that members of the medical community "are most supportive of steep hierarchies in which ju­ nior staff do not question senior staff."90 as such, healthcare providers ob­ jected ''voraciously'' to being saddled with externally imposed work hour 85. ld. ("[i]n an era of rising healthcare costs, shrinking funds at teaching facilities and increasing legal malpractice premiums, critics contend that whistleblower protection would aggravate an ailing health care system.j. 86. whetsell, supra note 7, at 63 ("[t]he bell regulations ... purpose was to regulate residents' work hours and supervision of their patient care.''). 87. see generally lin & liang, supra note 14, at 240 (discussing how the investigation into the death of a patient at the hands of an exhausted resident prompted new york to rethink the resident duty hour controversy). 88. i d. {"the bell regulations now limit resident hours to eighty hours per week. aver­ aged over a four week period, and no more than twenty-four consecutive hours.''). 89. id. (''noncompliance was ••• noted by ... the new york state health department, which cited fifty-four out of the state's eighty-two teaching hospitals for resident work hour violations during the period from november 1, 2001, through june 21, 2002."). 90. whetsell, supra note 7, at 63-64. 2008] expanded hospital liabiltiy under the federal fca 69 restrictions that undermined the near absolute authority traditionally granted them by the age-old master-apprentice model of medical instruction. 91 in 2000, in the wake of osha's adoption of the acgme's resident duty hour standards and enforcement regime, there was strong bipartisan support for federal legislation intended to promote the safety and well being of patients and residents alike.92 specifically, two bills introduced in the united states senate (referred to collectively herein as the "2000 acts") sought to impose the "vol­ untary (but not mandatory) reporting of medical errors'' and provided various protections for medical professionals and their patients. 93 similar in form to the bell regulations, the 2000 acts sought to impose explicit resident work hour limitations.94 unfortunately, despite strong support from major players in the health care industry, neither proposition ever received a floor vote.95 more recently, the patient and physician safety and protection acts of 2001 ("house bill 3236"),96 the patient and physician safety and protection act of2003 ("house bill 1228"),97 and the patient and physician safety and protection act of 2005 ("house bill 1297")98 were introduced in the united states house ofrepresentatives. like the bell amendments and the 2000 act, each of these bills attempted to impose strict limitations on the number ofhours that a resident could permissibly be required to remain on duty.99 unlike the bell amendments, however, these bills included provisions intended to func­ tion as enforcement mechanisms.10° for example, under house bill3236, res91. !d. at 64 there is great reluctance to abide by government standards for two addi­ tional reasons. first, hospitals traditionally have set their own standards, or theoretically follow the guidelines set by the accrediting organization and are generally suspicious of federal or state interference. the concern here is that regulations may be crafted by legislators who lack intimate knowl­ edge of the heath care system and fail to understand the heterogeneity within america's health care system. second, such regulatious put in place yet another blame system, which violates the very idea of the patient safety movement. aside from the possible citations and monetary penalties for failure to comply, an overwhelming fear of malpractice liability makes hos­ pitals very defensive. !d. (citation omitted). 92. !d. at 57 ("the past few years have seen some attempts at patient safety legislation."). 93. !d. at 57-58 (citing linda 0. prager, safety bills take voluntary tack on reporting errors, am. med. news, july 2000, at 6). 94. david abel, bill eyes guidelines on work hours for medical residents, boston globe, nov. 10, 2001, at b 1 (noting that the bills effectively limited total resident duty hours to eighty per week, resident shift lengths to twenty-four consecutive hours, and guaranteed that residents would receive at least one day off per week and one full weekend off per month.). 95. adams, supra note 18, at 1 (noting that despite strong support "[n]either proposal reached a vote."). 96. see h.r. 3236, 107th cong. (2001). 97. see h.r. 1228, 108th cong. (2003). 98. see h.r. 1297, 109th cong. (2005). 99. abel, supra note 94, at b 1. 100. cf., whetsell, supra note 7, at 58 (reviewing the regulatory provisions ofh.r. 3236). 70 indiana health law review [vol. 5:53 idents would be required to complete anonymous surveys to ensure hospital compliance, 101 a committee would be required to conduct annual on site inspec­ tions to assess the validity of the survey results, 102 and a substantial pool of fed­ eral funds would be made available to hospitals that incurred reasonable additional costs in achieving substantial compliance with the terms of house bill 3236.103 more importantly, however, house bil13236 and its progeny also permit­ ted residents to report duty hour violations directly to the secretary of health and human services, 104 provided reporting residents with whistleblower pro­ tections,105 and proposed stiff fines ofup to $100,000.00 for hospitals found guilty of violating the statute. 106 ultimately, in each of its incarnations, the pa­ tient and physician safety and protection act proposed amendments intended to reduce resident duty hours and enhance the supervision of residents; thereby, ensuring the safety of both the residents and their patients.107 unfortunately, like the 2000 acts all of these subsequent acts also stalled in committee.108 despite the best efforts of the amsa, patient advocacy groups, and legis­ latures on both the state and national levels, hospital administrators, medical educators, and professional medical organizations have, to date, successfully rebuffed all attempts at resident duty hour reform. recent decisions in the se­ venth and ninth circuits may, however, provide the tools necessary to breach the ivory tower of medical education, provide residents with the whistleblower 101. h.r. 3236 at§ 3(b)(4)(a)(statingthatanindividual withinthedepartmentofhealth and human services shall ''provide for annual anonymous surveys of postgraduate trainees to determine compliance with such requirements [designated herein] and for disclosure of the re­ sults of such surveys to the public on a residency-program specific basis."). 102. /d. at§ 3(b)(4)(b) {stating that based on the contents ofthe annual anonymous sur­ veys completed by residents in accordance with section 3(b x 4)(a) of the h.r. 3236, an individ­ ual within the department of health and human services shall in accordance with h.r. 3236 3(b)(4)(b) "conduct appropriate on-site investigations.''). /d. 103. /d. at§ 4 there are hereby appropriated to the secretary of health and human ser­ vices such [funds] as may be required to provide for additional payments to hospitals for their reasonable additional, incremental costs incurred in order to comply with the requirements imposed by [this] act (and the amend­ ments made by this act). 104. /d. at § 3(b )(2) {"a post graduate trainee or physician resident may file a complaint with the secretary of health and human services ... [ s ]uch a complaint may be filed anony­ mously. the secretary may conduct an investigation and take such corrective action with re­ spect to such a violation.''). 105. /d. at§ 3(c) ("a hospital ... shall not penalize, discriminate, or retaliate ... against an employee ... who in good faith .... reports a violation or suspected violation of such requirements to a public regulatory agency, a private accreditation body, or management person­ nel of the hospital."). 106. /d. at§ 3(b)(3) {"any hospital that violates such requirement is subject to a civil money penalty not to exceed $100,000 for each resident training program in any 6-month pe­ riod."). 107. compare h.r. 3236 with h.r. 1228 andh.r. 1297. 108. whetsell, supra note 7, at 58. 2008] expanded hospital liabll..ity under the federal fca 71 protections proposed in the house bil13236 and its progeny, and promote hos­ pital compliance with the acgme's resident duty hour standards. ill. making the grade: can graduate medical education withstand the assault of actions brought pursuant to federal the false claims acr? a. the importance of main & chapman the reluctance and apparent inability of the acgme to ensure broad hospital compliance with its resident duty hour standards notwithstanding, re­ cent decisions in the federal courts have exposed non-compliant hospitals with federally funded gme programs to liability under the fca. specifically, the recent decisions in united states ex rei. main v. oakland city university and united states v. chapman university have endorsed a legal theory that in­ creases the liability exposure, under the fca, of federally subsidized institu­ tions of higher education.109 b. the false claims act generally 1. the applicability of the false claims act the fca, originally enacted in 1863,110 grants private individuals stand­ ing to file suit in federal court in the name of the federal government.111 as amended in 1986, .. the fca imposes civil liability upon ' [a ]ny person' who, inter alia, 'knowingly presents, or causes to be presented, to an officer or em­ ployee of the united states government ... a false or fraudulent claim for payment or approval. "'112 thus, actionable claims filed pursuant to the fca must first establish that the defendant is a person within the meaning of the 109. see generally united states v. chapman univ., no. sacv 04-1256nsrcx, 2006 wl 1562231, at *2 (c.d. cal. may 23, 2006); united states et rei. main v. oakland city univ., 426 f.3d 914, 916 (7th cir. 2005). 110. vt. agency ofnatural res. v. united states et rei. stevens, 529 u.s. 765, 768 (2000) (''originally enacted in 1863, the false claims act (fca) is the most :frequently used of a hand­ ful of extant laws creating a form of civil action known as qui tam."). !d. ill. 31 u.s.c. § 3730(bx1)(2007) a person may bring a civil action for ... the person and for the united states government. the action shall be brought in the name of the gov­ ernment. the action may be dismissed only if the court and the attorney general give written consent to the dismissal and their reasons for consenting. 112. vt. agency, 529 u.s. at 769 (citing 31 u.s.c. § 3729(axi) (2007)). 72 indiana health law review [vol. 5:53 act, 113 and second, that the defendant acted knowingly to defraud the united states government of federal funds. 114 2. persons amenable to suit under the false claims act the united states supreme court (the "court") has held that the fca ap­ plies to any "person" who makes a knowingly false claim on the united states government for federal funds. 115 ironically, however, the fca does not explic­ itly defme the term "person."116 historically, there has been confusion regard­ ing the general applicability of the fca to state actors. this dilemma was resolved in vermont agency of natural resources v. united states ex rei. stevens, where the court stated unequivocallythat the term person as used in the fca "does not include the sovereign."117 moreover, the seventh circuit extended the protections afforded to the sovereign in ver­ mont agency to officials of a state or state agency acting in their professional capacities. 118 states and state agencies are not, however, entirely immune to prosecution under the fca. if an action is brought pursuant to the civil investigative de­ mand ("cid") provisions of the fca, which apply only to government actors, such as the attorney general of the united states (the "attorney general''), states are defined as persons. 119 thus, under the fca, private individuals have the requisite standing to bring suit in federal court on behalf of the united states so long as the party subject to suit is not a state, state agency, or a state actor. 120 if one of those entities is implicated, however, only a representative of 113. 31 u.s.c. § 3729(a)(l)(indicating that the act applies to "[a] ny person."). 114. united states ex rei. nudelman v.lnt'l rehab. assocs., inc., no. 00-1837, 2006 wl 925035, 13 (e.d. pa. april4, 2006) ("[njot all false statements made to the federal government are claims within the meaning of the false claims act; only actions which have the purpose and effect of causing the government to pay out money are clearly 'claims' within the purpose of the act."). 115. 31 u.s.c. § 3729(a)(l). 116. see generally 31 u.s.c. §§ 3729-3733 (2007). 117. vt. agency, 529 u.s. at 780; see also united states ex rei. krahel v. regents univ. of cal., no. c-96-1703 who, c-01-1893, 2001 wl 1548786, at *2-3 (n.d. cal. sept. 13,2001), aff d, 329 f .3d 1040 (9th cir. 2003) (stating that states and state agencies are not persons sub­ ject to being sued in a qui tam action under the fca). 118. pond v. bd. of trs .• ball state univ., no. 1:03-cv-00755-um-vs, 2004 wl 2538645, at *11 (s.d. ind. sept. 9, 2004) ("a lawsuit against an official of the state, or of an agency of the state, in his 'official capacity' is a suit against the state entity itself" (quoting kentuckyv. graham, 473 u.s. 159, 166 (1985))). 119. see31 u.s.c.a § 3733(a)(l),(4)(west2007); see also vt.agency, 529u.s. at 78384 ("[t]he fca ... enables the attorney general to issue civil investigative demands to 'any person ... possessi[ng] information relevant to a false claims law investigation' ... expressly defining 'person,' '[f]orpurposes ofthis section,' to include states .... "). 120. see vt. agency, 529 u.s. at 787 ("in sum, we believe that various features of the fca, both as originally enacted and as amended, far from providing the requisite affirmative indications that the term 'person' included states for purposes of qui tam liability, indicate quite the contrary."). 2008] expanded hospital liabn:jty under the federal fca 73 the federal government may file suit pursuant to the cid provisions of the fca.t2t the question of whether or not a state actor can be considered a person within the meaning of the fca is particularly important when considering the application of the fca to medical facilities with gme programs. although it is clear that both private for-profit and public not-for-profit hospitals would constitute persons within the meaning of the fca, prior to the court's ruling in vermont agency, it was unclear whether state-run hospitals and hospitals affili­ ated with state institutions of higher learning would be amenable to suit under the fca. given the court's ruling in vermont agency, as interpreted by the seventh circuit, however, such hospitals would clearly be amenable to suits filed under the cid provisions of the fca. the attentive reader may, at this point, be wondering how the fca can so neatly sidestep the doctrine of sovereign immunity established by the eleventh amendment. in fact, the court has held that no eleventh amendment issue arises when considering whether or not a state may be sued under the fca.122 in pertinent part, the eleventh amendment states that "[t]he judicial power of the united states shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the united states by [its] citizens ... .. 123 in vermont agency, the court considered once more the legal tension ex­ isting between the eleventh amendment and statutory law.124 with regard to actions against the state, the court noted that the "statutory question [is] 'logi­ cally antecedent to the existence or the eleventh amendment question," when questions regarding an eleventh amendment prescription against enforcing a statutory cause of action against a state must be balanced against a statute's own prescription prohibiting enforcement of such a cause of action.125 the court concluded that by addressing the statutory question first, there was no ''realistic possibility'' of expanding the court's power beyond judicial limita­ tions imposed by the constitution.126 moreover, the court determined that the "combination of logical priority and virtual coincidence of scope [made] it pos­ sible, and indeed appropriate, to decide the statutory issue first."127 according to the court, "longstanding interpretive presumption" sug­ gested that states were not ''persons" within the meaning of the fca and that 121. see 31 u.s.c.a. §§ 3730, 3733 (west 2007). 122. cf., vt. agency, 529 u.s. at 779. 123. u.s. const. amend. xi. 124. 529 u.s. at 779 ("we nonetheless have routinely addressed before the question whether the eleventh amendment forbids a particular statutory cause of action to be asserted against states .... "). 125. /d. at 779 (quoting amchem prods., inc. v. windsor, 521 u.s. 591, 612 (1997)). 126. !d. at 779 ("[t]here is no realistic possibility that addressing the statutory question will expand the court's power beyond the limits that the jurisdictional restriction has im­ posed."). 127. /d. at 779-80. 74 indiana health law review [vol. 5:53 private individuals did not have standing to sue states under the fca.128 there­ fore, when balancing the prescriptions of the eleventh amendment against the implied statutory limitations ofthe fca, the court determined that the fca itself precluded private individuals from instituting legal action against the state and saw no need to address the eleventh amendment issue at all.129 3. knowing action under the false claims act with regard to the fca's knowledge requirement, the text of the fca states that the knowledge requirement is satisfied when a defendant "has actual knowledge of ... information ... [but] acts in deliberate ignorance ... [or] reckless disregard of the truth or falsity of the information."130 this prescrip­ tion applies equally to claims filed by both private citizens and government ac­ tors bringing suit under the fca's cid provisions. 131 moreover, because a claim brought pursuant to the fca constitutes an averment of fraud, the claim will only be actionable if all allegations against the person who is the subject of the claim are pled with a particularity sufficient to satisfy the heightened plead­ ing requirements of federal rule of civil procedure 9(b). 132 4. bringing a claim pursuant to the false claims act: the qui tam suit an action brought pursuant to the fca can be commenced by either the united states department of justice, in the person of the attorney general, or by a private individual known as a qui tam relator.133 if the qui tam relator commences the action on behalf of the united states it is referred to as a qui tam action.134 regardless of who initiates the action, however, the "real party in interest in a qui tam action is the united states. "135 128. /d. at 780. 129. /d. 130. 31 u.s.c. § 3729(b)(l)-(3) (2007). 131. see 31 u.s.c. §§ 3730(a), 3733(a)(1) (2007). 132. united states ex rei. smith v. boeing co., no. 05-1073-web, 2006 wl 542851, at *3 (d. kan. feb. 27, 2006) ("'at a minimum, rule 9(b) requires that a plaintiff set forth the who, what, when, where, and how of the alleged fraud."' (quoting united states ex. rei. schwartzv. coastal healthcare group, no. 99-3105,2000 wl 1595976, at *3 (loth cir. oct. 26, 2000))); see also united states ex rei. donaldson v. conservation res. alliance, no. 031 0141-bc, 2006 wl 695674, at *3 (b.d. mich. mar. 14, 2006)("[c]onclusory allegations that the defendants' conduct was fraudulent do not satisfy rule 9(b ).''). 133. unitedstatesexre/. careyv.brock,no. 3:04-cv-131,2006wl 1195887,at*2n.2 (e.d. tenn. may 2, 2006) (''this matter is pursued as a qui tam action. in a qui tam action, the plaintiff sues on behalf of and in the name of the government and invokes the standing of the government resulting from the fraud injury."). 134. black's law dictionary 1251 (8th ed. 2004)(stating that qui tam is an abbrevia­ tion of the latin phrase "qui tam pro domino rege quam pro se ipso in hac parte sequitur, " meaning ''who as well as for the king as for himself sues in this matter"). 135. carey, 2006 wl 1195887, at *2. 2008] expand ed hospital liability under the federal fca 75 the government may elect to intervene in a qui tam suit by a relator. 136 if the government chooses to intervene and proceed with the qui tam action, it has "the primary responsibility for prosecuting the action and shall not be bound by any act of the private individual bringing the action."137 even after the gov­ ernment's intervention, however, the relator has the right to continue as a party to the action, subject to certain limitations.138 thus, the qui tam plaintiff retains a private right of action under the fca and is not merely a "statutorily desig­ nated agent of the united states!'139 the government, in the person of the at­ torney general, may also choose to proceed independently in an action brought pursuant to the cid provisions of the fca. 140 5. damage liability under the false claims act defendants in actions brought pursuant to the fca are liable for up to treble damages and a civil penalty of up to $10,000.00 per claim.141 generally, if the qui tam suit is successful the relator is eligible to receive a percentage of the funds recovered.142 the government may, however, choose to dismiss or settle the action at will. 143 i d. 136. cf, nudelman, 2006 wl 925035, at *13 an action under the false claims acts can be commenced in one of two ways. the united states department of justice (or the states' attorneys general under the state acts) can file suit, or, alternatively, a private plain­ tiff can institute a qui tam action on behalf of the united states (or the indi­ vidual state) to recover damages incurred due to fraudulent claims. 137. id. (citing 31 u.s.c. § 3730(c)(l)). 138. 31 u.s.c. § 3730(c)(l)("ifthegovernmentproceedswith the action, itshallhavethe primary responsibility for prosecuting the action, and shall not be bound by an act of the person bringing the action. such person shall have the right to continue as a party to the action, subject to ... limitation .... "). i d. 139. vt. agency, 529 u.s. at 772. 140. see generally 31 u.s.c. §§ 3730, 3732(a) (2007). 141. 31 u.s.c. § 3729(a)(l)-(7) any person who ... knowingly makes, uses, or causes to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the government, is liable to the unit­ ed states government for a civil penalty of not less than $5,000 and not more than $10,000, plus 3 times the amount of damages which the gov­ ernment sustains because of the act of that person .... 142. see 31 u.s.c. § 3730(d) if the government proceeds with an action brought by a person ... such person shall, subject to the second sentence of this paragraph, receive at least 15 percent but not more than 25 percent of the proceeds of the action or settlement of the claim, depending upon the extent to which the person substantially contributed to the prosecution of the action."). but see carey, 2006 wl 1195887, at *2 (discussing qui tam relator's share in the damages recovered in an action commenced under the fca and holding that "there76 indiana heal til law review [vol. 5:53 6. whistleblower protections under the false claims act the fca includes protections for whistleblowers that reflect the obvious federal interest in protecting informants who play an integral and necessary role in exposing fraud against the government.144 for example, the fca protects employees from retaliatory action, including harassment, suspension, and dis­ charge, resulting from their participation in or initiation of a qui tam action brought pursuant to the fca.145 a. protection and relief for whistleblowers: employers beware once a qui tam action is filed, whistleblowers are eligible for protection and relief, including reinstatement and an award of damages.146 moreover, as long as the government and employer are on notice that an employee is engag­ ing in a protected activity, the fact that the attorney general settles a claim does not limit the protections offered by the act. 147 such a settlement will also not bar a whistleblower's independent suit for retaliatory discharge. 148 further­ more, persons discharged from employment for participating in a protected ac­ tivity may bring suit to recover damages. whistleblower retaliation claims brought pursuant to the fca must, however, be commenced "within the time allowed by the most closely analogous state law limitations period."149 i d. /d. /d. lator has no personal stake in the damages sought by the government. 143. 31 u.s.c. § 3730(cx2)(a)-(b) the government may dismiss the action notwithstanding the objections of the person initiating the action .... the government may [also] settle the action with the defendant notwithstanding the objections of the person ini­ tiating the action if the court determines, after a hearing, that the proposed settlement is fair, adequate, and reasonable under all the circumstances. 144. see campbell v. aerospace corp., 123 f.3d 1308, 1315 (9th cir. 1997). 145. 31 u.s.c. § 3730(h) any employee who is discharged, demoted, suspended, threatened, har­ assed, or in any other manner discriminated against in the terms and condi­ tions of employment by his or her employer because oflawful acts done by the employee on behalf of the employee or others in furtherance of an ac­ tion under this section, including investigation for, initiation ot: testimony for, or assistance in an action filed or to be filed under this section, shall be entitled to all relief necessary to make the employee whole ... [including] reinstatement ... 2 times the amount ofback pay, interest on the back pay, and compensation for any special damages sustained as a result of the dis­ crimination, including litigation costs and reasonable attorneys' fees. 146. seeid. 147. id. 148. see generally neal v. honeywell, inc., 33 f.3d 860 (7th cir. 1994). 149. united states ex rei. smith v. yale univ., no. 3:02cv1205, 2006 wl 1168446, at *3 n.3 (d. conn. april28, 2006). 2008] expanded hospital liability under the federal fca b. federal jurisdiction: retaliatory discharge and whistleblower actions 77 in order to establish federal court jurisdiction over the retaliatory dis­ charge claim, a plaintiff must prove that he placed his employer on notice that he was participating in an activity protected by the fca.150 the plaintiff may establish notice if: (1) actions were taken in furtherance of a qui tam suit; (2) the employer knew of the actions; and (3) discharge occurred because of the actions.151 with regard to the extension of federal jurisdiction to wrongful termina­ tion actions brought in state courts, both the sixth and ninth circuits have re­ jected the notion that the fca ''justified the exercise of federal jurisdiction over a state wrongful termination action."152 the courts held that: [t]he fca's procedures augured against finding a sub­ stantial federal question in a state action relying on the fca . . . because a state-law tort claim so grounded would circumvent the procedures and limitations of the fca, and a contrary finding would open a "[sic] back door'' into federal court for what essentially was a state tort action.153 thus, the whistleblower provisions of the fca apply only to qui tam actions commenced in the federal courts. c. whistleblower actions: essential elements and limitations the prior commencement of a qui tam action is the essential element in establishing a right of action in a whistleblower claim brought pursuant to the fca. qui tam actions may not, however, be commenced against a state or a state agency by a private individual. therefore, because qui tam actions cannot generally be commenced against the state, and without a qui tam action no right of action in a whistleblower claim exists against the state, an arm of the state cannot be sued in a whistleblower action. the sixth and ninth circuits have held that the fca does not extend fed­ eral jurisdiction over wrongful termination actions initiated in state courts. thus, although the court did not address the issue of retaliatory discharge in 150. see generally robertson v. bell helicopter textron, inc., 32 f.3d 948 (5th cir. 1994) (holding that failure to establish a nexus between the filing of a qui tam action and discharge may result in a determination by the court that the employee was not engaged in a protected activity and therefore not amenable to the protections of the fca). 151. id. 152. eastman v. marine mech. corp., 438 f.3d 544, 552 (6th cir. 2006) (construing campbell v. aerospace corp., 123 f.3d 1308, 1315 (9th cir. 1997)). 153. eastman, 438 f.3d at 553 (quoting campbell, 123 f.3d at 1315). 78 indiana health law review [vol. 5:53 vermont agency, it can be presumed that states and state agencies are not ame­ nable to suit by private individuals bringing whistleblower'claims pursuant to the fca. states and state agencies may, however, be amenable to such suits if third party federal actors commence them. in such situations, whistleblower protections may well apply to adversely-affected private parties. c. government funding of graduate medical education: the essential link the fca is ''broadly phrased" to reach "'any person' who violates its provisions" by knowingly defrauding the federal treasury.154 as such, hospitals that rely on federal funds to pay their residents, medical educators, and support staffs, would seem to be subject to liability under the fca. moreover, resi­ dents working in gme programs would seem to have the standing required to bring qui tam suits, subject to the whistleblower protections, if those programs forced them to work dangerously long hours. indeed, even in cases where such violations are carried out by state actors in state hospitals, the attorney general would likely have standing to file suit pursuant to the fca's cid provisions. assuming arguendo that proponents ofresident duty hour reform are cor­ rect in their assertion that knowing violations of the a come's duty hour stan­ dards occur routinely in america's teaching hospitals, can the fca be applied to the problem? prior to osha's adoption of the acgme's resident duty hour standards and enforcement regime, the answer to this question would probably have been: no. indeed, despite the fact that the federal government has long served as the largest single source of funding for gme programs in public, private, and state run hospitals, prior to osha's adoption of the a come standards, compliance with those standards did not form a link in the chain of causation leading to the release of funds from the federal treasury.155 moreover, even after the federal government adopted the acgme's stan­ dards, the acgme monitored compliance with those standards. as a result, knowingly non-compliant hospitals seeking the acgme accreditation neces­ sary to serve as centers ofgme could apply for federal funding without making a knowingly false claim regarding compliance to the federal government. in­ deed, if a false claim regarding compliance with a come standards was made at all, it was made to the a come, a private accreditation group unrelated to the federal government and free from federal oversight in such cases, the knowing falsehood formed a link in the chain of causation leading to the release of fed154. united states~ rei. garberv. cityofnewyork, 8 f. supp. 2d 343,352 (2nd cir. 1998) (construing united states v. mcninch. 356 u.s. 595, 599 (1958)). 155. press release, ctrs. for medicare & medicade servs., office of pub. affairs, fy 2007 hosp. ipps proposed rulegraduate med. educ. (apr. 12, 2006) (on file with author), http://www.cms.hhs.gov/apps/medialpress/release.asp?counter-1835("financingofgraduate medical education (gme)-the period of training fuuowing graduation from medical school-is provided predominantly through inpatient revenues (both hospital payments and faculty physi­ cian fees) and a mix of federal and state government funds.''). 2008] expanded hospital liabn.ity under the federal fca 79 eral funds, but it was too attenuated to trigger liability under the fca. thus, despite osha's adoption of the acgme standards, hospitals could, without fear of prosecuqon under the fca, knowingly violate those standards. after the main and chapman decisions, however, hospitals no longer enjoy such freedom of action. d.' , the false claims act: expanding applicability recent federal court decisions in the seventh and ninth circuits have en­ dorsed a legal theory that extends the scope offca liability to false certifica­ tions of compliance made in the first phase of a multi-phase certification process.1s6 under this theory, false certifications of compliance no longer need to be made directly to the federal government in order to incur liability under the fca. 157 rather, to establish an actionable claim a plaintiff need only estab­ lish that the defendant knowingly made a false or fraudulent certification of compliance, 158 and that the false certification of compliance formed a link in a chain of causation ultimately leading to a demand on the federal treasury.159 1. one lie begets another: the chain of causation grows longer in main, a private individual brought a qui tam action under the fca against his former employer alleging that his employer, a private university, made fraudulent assertions regarding its eligibility to receive subsidies :from the federal treasury through the united states department of education.160 the department of justice did not choose to intervene in the action.161 specifically, 156. see generally main, 426 f.3d at 914; chapman, 2006 wl 1562231, at *1. 157. id. . 158. united states ex rei. hopper v. anton, 91 f.3d 1261, 1266 (9th cir. 1996) ("in fur. thering this goal, the act attaches liability, not to underlying fraudulent activity, but to the 'claim for payment' what constitutes the fca offense is the knowing presentation of a claim that is either fraudulent or simply false." (quoting united states ex rei. hagood v. sonoma county water agency, 929 f.2d 1416, 1421 (9th cir. 1991))). 159. main,426 f.3d at916 ("the [fca] requires a causal rather thana temporal connec­ tion between fraud and payment."). i d. 160. id. oakland city university assured the department ofeducation on its phase­ one application that it complies with the rule against contingent fees .••• [t]he relator in this qui tam action under the false claims act ••. contends that the university's representation was fraudulent. according to the com­ plaint, main himself received contingent fees as a recruiter and later as the university's director of admissions. initially main thought the compensa­ tion system proper, but when he learned of the federal statute and rule he filed this suit. · 161. id. at 917 ("the department of justice, though it elected not to take over the litigation ... has filed a brief as amicus curiae in this court contending that the allegations of the com­ plaint, if true, demonstrate a right to recover under the false claims act"). 80 indiana health law review [vol. 5:53 the qui tam relator contended that the university asserted willful falsehoods re­ garding its compliance with federal regulations during the first phase of the ap­ plication process, and as a result, the university was amenable to suit under the fca. 162 the district court dismissed the action on the grounds that ''willful falsehoods in phase-one applications [did] not violate the act, because the phase-one application request[ ed] a declaration of eligibility rather than an im­ mediate payment from the treasury." 163 the district court also noted that the willful falsehood was not repeated in the phase-two application, the application that directly preceded the demand on the treasury of the united states.164 on appeal the seventh circuit reversed, a.rgq.ing that but for the willful falsehood asserted in the phase-one application the phase-two application for payment could not have been made.165 specifically, the appellate court rea­ soned that the fraudulent statement made by the university in the phase-one application "caused" the phase-two applications to be submitted.166 the frau­ dulent statement in the phase-one application was, therefore, an integral ele­ ment in the "causal chain leading to paymenf' by the federal government.167 thus, main expanded the fca to encompass fraudulent claims made by a pri­ vate university, in the first phase of a two-phase application process for federal subsidies, even though the first phase did not include an immediate demand for payment from the united states treasury. 2. a chain attenuated does not break: reaping what you sow in chapman university, the court elaborated on the ruling in main, fur­ ther extending the scope offca liability. in chapman university, private in­ dividuals brought a qui tam action under the fca alleging that their former employer, chapman university, made fraudulent assertions regarding its eligi162. !d. at 916. 163. !d. 164. !d. (''the university 'uses' its phase-one application [containing the fhlsehood] (and the resulting certification of eligibility) when it makes (or 'causes' a student to make or use) a [falsehood free] phase-two application for payment."). !d. 165. !d. given the posture of the litigation, we must assume (as the complaint al­ leges) that the university (a) knew of the prohibition against paying contin­ gent fees to recruiters, and (b) lied to the department of education in order to obtain a certification of eligibility that it could not have obtained had it revealed the truth. these facts imply that the phase-two applications [though truthful] would not have been granted had the truth been told ear­ lier, for all disbursements depended on the phase-one finding that the uni­ versity was an eligible institution. 166. !d. 167. !d. ("if a false statement is integral to a causal chain leading to payment, it is irrele­ vant how the federal bureaucracy has apportioned the statements among layers of paperwork.''). 2008] expand ed hospital liability under the federal fca 81 bility to receive federal subsidies under the higher education act ("hea").168 in chapman university, however, the "causal chain leading to payment"169 was even more attenuated. 170 indeed, the qui tam relator in chapman asserted that the university "lied to the western association of schools and colleges ... about meeting accreditation" requirements for certain programs.171 relying on the logic of the main decision, the relators in chapman argued that, because chapman university could not operate certain programs without the accredita­ tion of the western association of schools and colleges ("w asc"), and be­ cause chapman university enrolled students who received federal subsidies in w asc accredited programs, the knowingly false statements made by chapman university to w asc constituted the basis for a claim actionable under the fca.172 chapman university argued that because w asc was a third party private accreditation organization, entirely unrelated to the united states government, any fraudulent or false statement made to obtain accreditation from the organi­ zation could not constitute a link in the chain necessary to establish an action­ able claim under the fca.173 chapman university reasoned that any such statement could not by defmition constitute a claim for payment directed to the federal treasury. 174 !d. 168. chapman, 2006 wl 1562231, at *1. [r]elators allege that ... [chapman], incidentto requesting and receiving hundreds of millions of dollars in federal ... funding annually [pursuant to the fca], falsely certified to the united states of america ... that they are in compliance with federal provisions requiring that instruction meet cer­ tain minimum clock-hour requirements. 169. main, 426 f .3d at 916 (7th cir. 2005) (''if a false statement is integral to a causal chain leading to payment, it is irrelevant how the federal bureaucracy has apportioned the state­ ments among layers of paperwork."). 170. chapman, 2006 wl 1562231, at *2. 171. !d. 172. !d. ("relators contend that chapman's false certification of the number of hours worked by its faculty and false certification that it provides supervised clinical instructions ... are material and fundamental conditions of payment of government funds for tuition loan and grants ... " from the federal government.). !d. 173. jd. chapman contends that ... the documents to which relators refer are gov­ ernment forms or government contracts that either directly or indirectly re­ quire chapman to follow applicable statutory and regulatory schemes, which require that chapman is accredited by a regional accreditation au­ thority, such as w asc. chapman avers that relators claims fail because state and federal financial tuition assistance does not depend on complete compliance with the guidelines of an accreditation agency, such as w asc, but rather depends only on being accredited by an accreditation agency. 174. see !d. at *4 (contending that "relators fail to allege any payment of public money that was supposedly conditioned on a particular report from chapman to wasc."). 82 indiana health law review [vol. 5:53 chapman university also distinguished main by pointing out that in main, the university's receipt of federal subsidies was conditioned upon a statu­ tory regulatory requirement; whereas, chapman university was subject to no such requirement.175 chapman university's arguments notwithstanding, the district court ruled that under the analytical fratitework established in main, chapman university's "allegedly false certifications to wsac" constituted the first step in a ''two-step fraud purportedly accomplished" by chapman univer­ sity.176 thus, in chapman the fca was expanded to encompass fraudulent claims made by a private university to a private non-governmental accreditation agency whose accreditation program made it possible for students receiving federal subsidies to attend university classes. n. expanded liability under the false claims act: in the wake of main and chapman a. expanded liability of universities generally: why hospitals should take note in main and chapman, the seventh and ninth circuits indicated their wil­ lingness to impose liability under the fca for false certifications of compliance made at any stage of a multi-stage certification process. in main, false certifica­ tion of compliance in the first-phase of a statutorily prescribed two-phase ac­ creditation process was sufficient to create a cause of action under the fca. the court in chapman expanded the main decision. broadly construed, the court in chapman held that, even if a false certification was not made directly to the federal government or in response to a statutory regulation specifically requiring accreditation by a particular agency, it would be sufficient to create a cause of action under the fca, as long as it formed a link in a chain of causa­ tion ultimately leading to a demand on the federal treasury. the willingness on the part of the federal courts to extend the scope of fca liability to false certifications of compliance made in the first phase of a multi-phase certification process will undoubtedly make private colleges and universities more amenable to suit by qui tam relators. however, because the court in vermont agency ruled that private individuals do not have standing to bring qui tam actions against states or state agencies, state universities are really no more vulnerable to qui tam actions in the wake of the main and chapman decisions than they were before the cases were decided. that is not to say, however, that the rulings in main and chapman will not increase the vulnerability of state universities to suit under the fca. v er­ mont agency merely stated that private individuals lack standing to sue states 175. chapman, 2006 wl 1562231, at *3. 176. id. at *5. 2008] expanded hospital liability under the federal fca 83 and their agencies under the fca. it did not eliminate the power of the attor­ ney general to file actions pursuant to the cid provisions of the fca against state universities. therefore, even though private individuals are precluded under the fca from pursuing qui tam actions against state universities, the at­ torney general is still free to file equivalent actions under the cid provisions of the fca as long as the complaint meets the knowledge and pleading require­ ments prescribed by the act. moreover, because the rulings in main and chapman broadened the scope of false claims actionable under the fca, the liability of state institutions to such claims has clearly been increased. conse­ quently, in the wake of main and chapman state universities should make a concerted effort to ensure that they avoid making knowingly false certifications of compliance in any phase of an accreditation process aimed at securing fed­ eral subsidies under the hea. b. the expanded liability of hospitals with federally funded graduate medical education programs the rulings in main and chapman were clearly tailored to curtail the abil­ ity of state and private universities to receive federal funding if they fail to comply fully with the requirements of any accreditation agency permitted to determine a university's eligibility to receive federal funds at any stage of an accreditation process. as such, the rulings would also seem to dramatically expand the applicability of the fca to claims brought pursuant to the act against any teaching hospital that receives federal funding. hospitals employing the services of graduate medical residents receive a majority of the funding for their residency programs from the federal govern­ ment through the medicare program. moreover, to receive such funding, hospi­ tals with gme programs must be accredited by the acgme. accreditation by the acgme is premised upon compliance with, among other things, the duty hour limitations imposed on residents by the acgme. prior to the holdings in main and chapman, it could be persuasively argued that a hospital's failure to comply with the duty hour limitations of the acgme, a private accreditation agency, did not constitute behavior implying liability under the fca. under the logic of the holdings in main and chapman, however, hospitals that know. ingly fail to comply with the acgme 's duty hour limitations would probably be liable under the fca for defrauding the federal treasury. 1. hospital liability under the false claims act: a statute reinterpreted hospital liability under the fca for violations of resident duty hour stan­ dard violations would be premised upon existing federal law as interpreted by the federal courts.177 as such, federal legislation governing the duty hours of 177. united states ex rei. raymer v. univ. of chi. hosp., no. 03 c 806, 2006 u.s. dist. 84 indiana healtii law review [vol. 5:53 medical residents is no longer necessary. under the federal judiciaries rulings in main and chapman, strict compliance with the a come duty hour standards adopted by osha is required of any hospital receiving federal funding for its gme program. furthermore, given the applicability of the fca, enforcement of the acgme' s duty hour standards in hospitals that refuse to comply is no longer problematic. residents, acting as qui tam relators, are free to bring claims against any public or private hospital that knowingly fails to enforce the duty hour standards. even hospitals associated with state universities would be amenable to suit brought by the attorney general pursuant to the cid provi­ sions of the fca. 2. whistleblower protections for sleepy residents: a dream come true in addition to facilitating enforcement of the acgme duty hour stan­ dards, the federal judiciary's expansion of the fca's applicability in main and chapman also ensures that residents, acting as qui tam relators, could enjoy all of the whistleblower protections afforded by the fca. in the wake of these rulings, many of the practical impediments that formerly curtailed the efforts of resident duty hour reformers and patient advocacy groups have theoretically ceased to exist. residents, though still subject to the challenges imposed by the traditional master-apprentice paradigm of medical education, may now engage in the self­ reporting essential to the enforcement of the acgme's resident duty hour standards. if residents report duty hour violations, file a qui tam action seek~ ing enforcement of the duty hour standards, and are discharged or harassed as a result; they are free under the fca to bring suit in federal court for retaliatory action. moreover, assuming that the fca is applicable to acgme duty hour violations, self-reporting residents can retain relative anonymity; thereby, avoiding the need to face a no win situation in which compelling hospital com­ pliance with duty hour standards will most likely result in injury to their nascent careers. furthermore, hospitals with gme programs found guilty of violating the acgme resident duty hour standards, while receiving federal subsidies, would likely be found guilty of defrauding the federal treasury. theoretically, resident whistleblowers, patient advocacy groups, and members of the amsa, acting as qui tam relators, would be eligible to receive a sizable percentage of the treble damages and civil penalties likely to be levied against any hospital found guilty of violating the standards.178 moreover, the attorney general would be independently eligible to prosecute offending hospitals under the fca. lexis 7943 (7th cir. feb. 28, 2006) (demonstrating the willingness of the federal courts to apply the main standard of enhanced liability to claims filed against federally funded hospitals generally). 178. 31 u.s.c. § 3729(ax1)-(7). 2008] expanded hospital liabll.jty under the federal fca 85 v. conclusion the resident duty hour controversy has long been a polarizing issue in the american medical community. rooted as it is in the very bedrock of the master-apprentice paradigm of medical education, the resident duty hour ques­ tion has effectively defied intervention by legislatures, residents, the amsa, and private individuals. the obdurate stance adopted by medical educators and medical professionals within the ama and acgme has rendered ineffective the resident duty hour standards adopted by osha. it would seem, therefore, that resident duty hour reform is unlikely to take root naturally in the united states, despite the will of the general population. recent decisions in the seventh and ninth circuits, however, have dra­ matically altered the landscape of the resident duty hour controversy. by mak­ ing the fca applicable in any situation where federal funding is procured through knowingly fraudulent means, regardless of attenuation in the chain of causation leading to the procurement, the precedent set by the courts in main and chapman changed the very nature of the debate. prior to these decisions, proponents of resident duty hour reform had few tools suited to the task of bringing about change in the medical community's perception oflimited resi­ dent duty hours. in effect reformers efforts were largely ignored or marginal­ ized by medical practitioners' intent on preserving the stasis quo. the precedent set by main and chapman has provided residents and other inter­ ested parties with the leverage necessary to effectively challenge hospitals and supervising medical practitioners who refuse to adhere to the resident duty hour standards promulgated by the acgme. these standards, if enforced, would ensure that residents are not required to provide potentially life saving medical care while suffering from chronic sleep deprivation. thus, given the precedent set in main and chapman, the question is no longer if private and state run hospitals will comply with the acgme •s resi­ dent duty hour standards, but when they elect will do so. indeed, if hospital managers, medical educators, and representatives of the acgme choose not to comply with the standards, they may face large financial penalties under the treble damages provision of the fca. thus, it can be presumed that, even though the american medical community has been slower than its counterparts in other nations to adopt resident duty hour reforms likely to benefit residents and patients, it will find ample reason to adopt such reforms if doing so will avoid stiff financial penalties. the motivation behind the compliance notwith­ standing, it is the residents and patients who will reap the greatest reward from the application of the fca to the resident duty hour controversy. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i hospital-physician joint ventures: a promising p artnersbip? transcript of live symposium panel discussion* february 2 i, 2007 mr pemberton: our goal today is to respond and elaborate on some of the themes that professor blumstein proposed earlier this afternoon in such an eloquent way. namely, the integration to which he referred repeatedly: the idea that a hospital and a physician must find a way to work collaboratively and have aligned incentives to reach quality outcomes, and therefore, triumph in the marketplace. there are many concepts in these few words, but that is really the kind of insight that we are going to hope to bring to the topic. we think we have struck a nice blend between the practical implications, what is actually happening in terms of achieving this model that professor blumstein proposed and what is actually going on in the field, by sharing some hands-on experi­ ence. i think you will find a good combination of a very real world experience both locally, regionally, and in mike finnerty's case, even on a national scale. • indiana health law review and the williams. and christine s. hall center for law and health at the indiana university school oflaw-lndianapolis give special thanks to the fol­ lowing speakers for participating in the symposium and providing their unique and infonnative perspectives on physician-hospital joint ventures, as well as for reviewing and allowing the indiana health law review to publish this transcript: professor james f. blumstein vanderbilt university law school gregory l. pemberton partner, ice miller llp, chair, health law section, american bar association norman g. tabler senior vice president & general counsel, clarian health partners steven h. pratt partner, hall, render, killian, heath & lyman, p.c. adjunct professor of law, indiana university school of law-indianapolis dennis l. pippenger, m.d. private practice, ob/gyn specialists ofindiana michael j. finnerty vice president kaufman hall & associates, inc. 264 indiana health law review [vol. 4:263 with that, let me pose the first question, and it will go to norman tabler. norm is the general counsel of clarian health partners and has had a very prac­ tical hospital-physician integration project, which they are currently working on. if you would, norm, take a few minutes and share some of the insights and lessons learned. mr. tabler: sure. i want to talk about what i think is the primary cause of the dysfunction and the increasing dysfunction of the traditional hospi­ tal-physician relationship. i want to talk in particular about a concrete example that my organization is using to try to address this. we at the organization are hopeful that this will be effective and perhaps one model for repairing some of the problems that professor blumstein has talked about. the problem is disaggregation. it is the fact that when we have the medi­ cal care in america, particularly when it is in a hospital facility, really whether inpatient or outpatient, there is a complete disaggregation of the interests of the various economic components. the various components are not aligned. they are competitive, as professor blumstein elaborated on, and often, they are pre­ cisely in conflict. now, typically in america from day to day we don't really know this. we think of a hospital generally, certainly lay people do, as an inte­ grated single entity, and i think the typical american finds out otherwise when he starts to get invoices after a stay at the hospital. i had some fairly routine surgery a couple of weeks ago, and to do that, i interacted ftrst with the primary care physician who referred me to a surgeon. this surgeon scheduled an appointment at the hospital. i interacted with an anesthesiologist and i think if i were not in the business, i would have assumed that all, if not certainly most of these physicians, were related and part of a sin­ gle economic unit. but anybody who thinks that will be completely disabused as the invoices start to roll in, because you get an invoice from the primary care physician, from the anesthesiologist, from the surgeon, from the hospital, from the laboratory. those entities typically have no economic relationship with one another, and for reasons that were outlined earlier today, it is often illegal for them to have economic relations. think of any other experience you have with the american economy and certainly with an important industry, you'll ftnd that it is completely opposite. if you fly in an airplane, you would be stunned to get bills from the airplane owner, from the pilot, from the flight attendant, from the baggage handler and from the flight control personnel. if you have a car repaired, you would be as­ tonished if you got a facility fee, another bill for parts, and another bill for la­ bor. and the damage is not just that there is no alignment or aggregation or in­ tegration of these economic interests. the fact is they are very seriously at odds with one another in a lot of ways. a simple example would be that the typical hospital today is paid on a diagnosis-related group ("drg") basis. that means that the hospital is going to get paid the same amount of money for a stay, no matter how long or short it is. therefore, it is in the hospital's economic inter2007] panel discussion 265 est to have a short stay; however, the physician has an interest in a long stay. a physician has an interest in consultations on several days, rather than just one. the operating room is another example. it is in the surgeon's interest to block as much time, and to hold the blocked time in the operating room as much as possible. it is in the surgeon's interest to order more blood than he might need at a direct cost to the hospital. now, why do we have in this industry, this important industryofhospitals and medicine, this disaggregation? it is curious, because the answer is not that hospitals do not want to play by the normal rules, it is that they are not allowed to play by the normal rules that other industries follow. the obstacles to integration also include simply tradition and culture. for example, the tradition in america is that physicians want to be independent a person is motivated to go to medical school in part because he or she wants in­ dependence and wants to be in control of his or her own destiny. i might say, parenthetically, that this seems to be changing. we increasingly see physicians who really do want to be employees. we also have a cultural bias in the general attitude of the public. in some of the cases we heard about earlier, the traditional view, and really the view that still exists today, is that an exempt hospital has a duty to care for a patient who cannot pay. if the hospital does not fulfill that duty, then there is no community benefit. we do not apply that to any other industry, including nonprofit indus­ tries. we would not say that a university serves no public benefit because it refuses to admit students who do not pay the tuition. we would say that educa­ tion in itself is a community benefit. moreover, the list oflaws and regulations, including the anti-referrallaws, the antitrust laws, the stark law, the laws of26 u.s.c. §501(c)(3), all also create obstacles. i want to give you an example of something that we are just starting, in fact, two weeks from today, at this very hour, we are going to have the topping­ off ceremony in lafayette. clarian has joined forces with the arnett clinic to create a new general hospital, likely known as clarian arnett, in lafayette. the arnett clinic is a one hundred and fifty-odd physician specialty group. it is one of the oldest large multi-specialty groups in the united states, dating back to the 1920s. we have joined forces, and we are going to build a hospital of one hun­ dred and fifty beds, an outpatient center, and an attached medical office build­ ing. it is going to be a general hospital. that makes it different from other hospital ventures that you see. it is going to have an open staff. it was de­ signed originally by the arnett clinic physicians. it is going to be a sixty/forty llc, clarian sixty percent, and the clinic forty percent. i will tell you why we have that that number in a second. the clinic is contributing all assets, including all future income streams other than the professional fees. so they are contributing all ancillary income and the technical component of fees. we really think of ourselves as fj.fty/fifty partners, so why the sixty/forty division? one reason is the legal obstacle of the antitrust law. our market in 266 indiana health law review [vol. 4:263 central indiana over at clarian overlaps with the market of the hospital we are building, and we would be competitors of one another if we were not in control. so that was a powerful motivation for clarian to have well over fifty percent. there are considerations under the law of tax-exempt organizations that make it better and safer for us to control the organization rather than to be an equal partner, and the sixty/forty split is one of the prongs of an anti-referral law safe harbor. i want to very briefly tell you some of the disadvantages and, some of the advantages that we foresee. normally, i would start with the advantages, but i want to end on a high note. the disadvantages are that we were forced to use taxable financing. for an organization like ours that is used to the benefit of tax-exempt bonds, it is pretty sobering to go into the taxable market. we will have to look over our shoulders for the irs throughout the opera­ tion of this venture because of the rules that apply to us under 501(c)(3). we have a concern that the ever increasing number of taxable ventures will cause a substantial part of our operations to be for-profit, and that is a test that we can­ not afford to fail. i think it is also a risk to build a general hospital. new hospitals, the new physician-hospital ventures you hear about, are almost invariably specialty hos­ pitals, and it is not an accident that the specialties that are hit are the high­ income specialties. we are going to try to create a general hospital. perhaps one of the most basic questions of all is whether the community can and will support another hospital. lafayette is a one-hospital town. they long had two competing hospitals, but the two hospitals merged, resulting in a one-hospital town. one of the advantages that i believe we will manage is what i call the dis­ aggregating of interests. first of all, the doctors designed this hospital. they designed the plant; they will govern the hospital on a sixty/forty basis; and they will manage the hospital. this new venture through the association with the very large clarian op­ eration, will get certain economies of scale, group purchasing advantages that a freestanding hospital could not hope for. in our case, and this would not apply to some other hospitals, there will be a bridge from the doctors in the clinic and in the hospital, to the school of medicine, and that is very important to them. there will also be a bridge from clarian and the school of medicine to purdue, and that is very important to us. finally, and most importantly, and this is what i am going to end on, there will be an alignment of financial, quality, and other such interests. these doc­ tors, this ready-made medical staff, will have precisely the same interests that the hospital owner has in operating an efficient, high quality hospital, and in paying attention to the economic and market considerations that professor blumstein discussed in the first session of this meeting. mr. pemberton: norm has shared one version of integration, the one that they are pursuing in a particular market. steve pratt will talk for a few mi2007] panel discussion 267 nutes about other models for integration, short of total integration through own­ ership of a hospital. mr. pratt: first, i would comment that i agree with the problem as norm tabler has identified it, and i would add one point. in our health care system there is a disconnect between the authority to make decisions and the consequences of the decisions on the economic side. physicians can make the decision to extend the length of the stay, order additional tests, and so forth, and the cost consequent to that is not borne by the physician at all. in fact, there might be a benefit to the physician, and i do not mean to be critical of physi­ cians. i do not view it as a physician problem or a hospital problem. it is a structural problem. but that is a dynamic that we tried to change, and norm tabler has given one example, which is integrating through ownership, where we align interest through ownership of the facility. another model for a 501 ( c )(3) that does not want to do a new hospital, or a new facility of some type, is a contractual joint venture. the purpose of such a joint venture, for example, would be to manage a service line, for example a cardiac or orthopedic service line. or you jointly operate an imaging center or an asc as a distinct and separate approach to how you can collaborate with physicians; you then bring them to the technical side of medicine, the facility side, the hospital side, and have them work collaboratively with you as though it was a contractual joint venture. moreover, there are limitations. it has to be a legitimate joint venture and ideally the physicians will have some legitimate business risk in the venture. now, the government has been critical of sham arrangements. these ar­ rangements purport to be joint ventures when in fact, they are just an arrange­ ment to get money to doctors when there is not much service being provided and no business risk being assumed. however, if your real purposes are to im­ prove quality and efficiency of care, and if you have real services being pro­ vided, and ideally the physicians are taking some genuine business risks, i think you can use a contractual joint venture model as an alternative approach to cre­ ate alignment. i think the purpose for the venture has to be driven by a desire to make the health care facility a better place to receive care. by creating a better facility for physicians to give health care, you can improve the quality and the efficiency of the care received. one of the boundaries we work within, as do hospitals, is that we are not allowed to pay money to induce referrals. we are also notal­ lowed to pay money to induce reduction of care, even if the care is not medi­ cally necessary. we are not allowed under the civil monetary penalties law to pay money if the purpose is to induce a reduction in care, even if in theory, that care was medically unnecessary. it seems that there should be a process, a means for hospitals and physi­ cians to work together to eliminate unnecessary, expensive care. i know one of the things that we wanted to talk about is an example of how a venture of this type has worked, and dennis pippenger was in management at riverview hos268 indiana health law review [vol. 4:263 pital when they developed their surgery management company. one of the things we thought we would do is talk about how that happened, why that hap­ pened, and whether it has been successful. now, professor blumstein made some comments about studies that have shown that integration of this type perhaps does not create the economic bene­ fit. we are going to give you an example today where it has. dr. pippenger: i have been in practice in noblesville since the com­ pletion of my training at methodist hospital in 1979. in 1998 i was recruited by the hospital to become vice president of surgical services and the medical affairs area. at that point in time, we were having some difficulties with the operations within the surgery department typical of many hospitals where there was no alignment of incentives, and people were not communicating properly. there were problems. surgeons were unhappy. there was too much delay be­ tween cases and employees were not being responsive. it is not an unusual problem throughout hospitals. additionally, other market forces, such as surgi­ cal joint ventures from other areas, put the hospital under pressure to come up with a better way of doing things. the program that was developed was called riverview surgical manage­ ment associates, otherwise known as rsma, which is the management form of a joint venture. basically, rsma is a company that manages the surgical op­ erations at the hospital. all the employees in the surgery department were hired by rsma. they were no longer riverview employees, giving them a direct link to the company and the ability to see who was running the show. the company was comprised of equal membership, fifty percent owned by physician-surgeons and anesthesiologists, and the other half owned by the hospital. there was a board of eight people, four from the hospital, four elected from the physician-owners. the company then assumed all responsibility for the employees, human resources, case scheduling, and the ambulatory side where patients were admitted: the whole shooting match so to speak. to make a long story short, it worked very well. it took a while to estab­ lish a new culture with the employees. the employees, i would point out, be­ came incentivized financially. we had some incentives initially based on the number one. the highest incentive was on patient satisfaction, which was measured through a press ganey survey on a "likelihood to recommend" score. that was by far and away the largest incentive payment that came into the man­ agement company, and that employees participated in on the incentive side. we also had an incentive for room turnover times, which was one of our problems. a budget was developed for that department. the ability to stay within the budget provided another incentive. the budget was derived through communications at the board level ofrsma. it was not just driven by the hos­ pital anymore. we had physician input, indicating that there were problems with equipment not being there. the lack of equipment was slowing the proc­ esses down. i believe the communications really solved a lot of problems for the phy2007] panel discussion 269 sicians and the incentives worked very well. the employees understood what needed to happen, and the culture of the whole area changed. i think our "like­ lihood to recommend" scores were somewhere in the low eighty percent. i just happened to see, hot off the press from february 20th in the riverview view­ point, a newsletter to the employees, that the ambulatory surgery area was awarded the highest score in the hospital, ninety-six percentile. since rsma took over, it is traditionally around ninety-two percent to ninety-four percent, so it went up considerably. the patients are really benefiting from what has happened there. the sur­ geon-owners have driven the process to work and have seen to it that their col­ leagues, who may have not been part of rsma, still enjoy coming to our hospital. the surgeons are much more efficient; there is not nearly the amount of wasted time. i think room turnovers went from about thirty minutes to about eight minutes between cases. they have put in some new incentives lately. administering antibiotics before surgery is one thing. it is recommended that prophylactic antibiotics be given within the hour prior to the start of the surgical procedure. therefore, one of the incentives for bonus payment to surgical staff measures the time of ad­ ministration of the antibiotic and it must be within the time:frame listed. this is an example of how incentive payments work toward compliance with best prac­ tices. this particular incentive was initiated to change behavior and provide for better patient care. the number of cases of noncompliance decreased to a very small percentage as a result of this strategy. the joint commission has been interested in seeing that happen, so now that is measured. i think anything that you measure will improve. the haw­ thorne effect, i think, is what it is called. we put a lot of measurements in place, and things have improved. it has worked very well. i did this for about six years and then went back into full practice again. the process and the cul­ ture continue under the current leadership. mr. pratt: i think one way to look at it is as norm has described: ac­ tual ownership, you have equity in the venture. what we have tried to create through contractual joint ventures is something similar to virtual ownership. you feel, as a physician, a sense of accountability for scheduling issues, for nurse satisfaction issues, for the consequence of wasting supplies, things of that type. you do not have ownership, but you have a sense of responsibility and ideally a reward for fixing problems because of the virtual ownership. mr. pemberton: steve pratt, would you also just touch on some of the bigger legal issues that you wrestled with? mr. pratt: norm tabler hit on them at a high level; one is the laws that affect tax-exempts. we have to operate in a manner that serves the com­ munity. we have to ensure that we do not have too great a portion of our in­ come from activities that are unrelated to our charitable purpose of giving 270 indiana health law review [vol. 4:263 health care. the irs is always watchful of what we do. another legal issue is the stark law, which says if a physician has a finan­ cial relationship with a hospital or other provider, then that physician cannot make referrals to that facility, unless the arrangement can be structured to fit within a stark exception. like any good law it is riddled with exceptions, and there are exceptions to the exceptions, and it is a fascinating maze to work through, but it is one of the barriers that we face as we try to create relation­ ships with physicians. we have to structure the arrangements to fit within a safe harbor. we have talked a lot about the anti-kickback statute, which makes it a fel­ ony to pay money to induce a referral. it is a criminal law, so the point of proof is your mind-set: what did you intend? thus, we are very careful to structure our arrangements to emphasize the good, lawful reasons that we are doing them; mindful that if one reason among many others is unlawful, if one reason of the hundreds that you are creating the venture is to induce a referral, it is unlawful. finally, the one statute i mentioned, the civil monetary penalty statute ("cmp"), says that a hospital cannot pay money to induce a reduction in care. this becomes a barrier when you are trying to work with physicians, for exam­ ple, to manage supply costs, reduce staff costs, or to manage length of stay is­ sues, because we cannot directly incentivize physicians to reduce those costs, which are hospital costs, by paying money. it would violate the cmp. mr. pemberton: lfi can ask both dennis pippenger and steve pratt a question specific to this transaction? riverview is a county hospital; it is a governmental hospital. i am really asking two political questions. first, how did you deal with large "p" politics in terms of a public institution entering into this new relationship? was there any, or how did you manage any potential political fallout? second, how did you deal with the internal political issues, in the sense that some physicians were in, some were not, and some were owners, some were not? so we're addressing the dynamics within the medical staff, what form of small "p" politics did you have to deal with, and how did you work through them? dr. pippenger: i think the small politics were the large ones for me with medical staffbecaqse there were a lot ofhard feelings at the time. i think the people who went with the rsma model recognized and understood that. i think our goal was to improve the operation at the hospital at riverview be­ cause the other physicians invested in an outpatient facility, and we knew that they were still loyal and wanted to come with their inpatients and certain outpa­ tient things as well. we wanted to create an environment that was welcoming and showed that yes, this is a different deal now, and it is a place that you will want to come to and you will enjoy the way business is going to be run. i think the initial problems politically amongst the physicians disappeared because of the dramatic improvement in their environment. it is a place people 2007] panel discussion 271 want to come to. it is a place where people would like to be employed, and as i showed, the statistics bear that out and everybody wins. furthermore, i believe that when it is working well, it is a safer environment for the patients participat­ ing in the process as consumers. on the larger political scale, this was something the hospital wanted. the hospital board members, who are appointed by the county commissioner, wanted this, so to that end, the large political side had been dealt with initially. i believe that the things that were promoted made sense to those people in the political arena. i suppose when you have a good outcome, there is not a whole lot of controversy. mr. pratt: i have always viewed it as there being three drivers that re­ ally allowed riverview to do this. one is that there was a faction on the medi­ cal staff that was pulling away to do their own competing center. that split the medical staff and was a real threat to riverview, so that enabled them to work with those physicians who were willing to create rsma. in some senses, it was an alternative vehicle for what i will call the "friendly physicians," tore­ main at riverview working, and performing their outpatient surgery there. secondly, it is a growth market, so management in a sense can afford to make some mistakes because if they misjudge the market, they will be able to catch back up due to the fact that it is still growing. this is not true in all com­ munities. sometimes you make mistakes on a significant strategic venture like this and it takes you a decade to recover. thirdly, i think riverview has always had good management, a good board, and good commissioners that let the board and management run the hospital. this is certainly not always true of county hospitals in indiana. i can think of another example with similar circumstances. an asc was being formed by the unfriendly physicians on the medical staff. when the hos­ pital responded, instead of finding a way to collaborate, they went to the com­ missioners who replaced board members, who then fired management. as this demonstrates, the politics are very serious at the county hospital level and it does not always tum out as favorably as it did for riverview. mr. pemberton: mike finnerty, i want to drag you into this conver­ sation. i think we will probably touch on some more examples that we have seen happening in the market, but could you take a couple of minutes and talk about the larger market forces? mike's practice takes him on a national scale, which is very helpful in this regard. mr. finnerty: it is interesting to stand back and take a more aca­ demic view of things, and professor blumstein's speech was fantastic in dis­ cussing several of the legal aspects that are driving some of these joint ventures. it took me back to the first transaction i worked on as a newly minted mba. it was a physician practice acquisition, where we got a sixty physician practice group for the unbelievable price of thirty million dollars, $500,000 a doctor, but 272 indiana heal1h law review [vol. 4:263 at the time it was all the rage. in our practice, joint ventures fall into mergers and acquisitions ("m&n'), so i am in the m&a group, and we do that because we believe that joint ven­ tures have a lot of transactional aspects to them, so that is probably what i am more prepared to talk about. a lot of the factors that were there when we were looking at those physician practice acquisitions are really emerging today, and we do look at a lot of the joint ventures somewhat skeptically. included in your packet is the white paper that we wrote on joint ven­ tures, and if you will notice, it is not overly encouraging of them. i think it is more matter of fact in that if it is something you are going to do, here are the best practices and here are the things you need to think about, because i think the jury is still largely out. i think fundamentally what was driving physician practice acquisitions in the 1990s was a perception among physicians that they were not getting enough of the health care dollar, and in reality they are right. there was also hospital­ to-hospital competition, which was all amplified by for-profits that were com­ ing into this space; these for-profits were physician practice management com­ panies, phycore, phymatrix. i think we were joking earlier that what would happen is one of them would fly in with their jet to the rural town. the hospital administrator would have heard about it within fifteen minutes, and then all of a sudden they were in negotiations to buy the practice in town, which is frankly what most of the physicians would have preferred over a for-profit company. the other one had a yacht, so if all your physicians left for a weekend to head to miami, you knew you had some concerns. additionally, you had for-profit hospitals coming into the market, and thus were confronted with the peer pres­ sure, and the fear that they would be better able to partner with them and be more efficient. today across the country we have many of the same dynamics that we had in the 1990s. a lot of the joint ventures that you are seeing these days, particu­ larly ascs and image basing, are being enabled by outside for-profit compa­ nies. they are bringing the capital, they are the us pis of the world. some of them are hospital friendly, some of them are not. it is still a very fragmented industry and there is a lot of angel investing, and there is an awful lot of private equity in the sector. they will come with the management expertise, and will get a group of doctors together, particularly around the technology. we are do­ ing a proton beam therapy in the southwest, and i cannot even really tell you what it is supposed to do, but it is hugely expensive. it is a for-profit company that came in and gave the hospital in town the unbelievable opportunity to in­ vest in it. they had virtually no equity in this enterprise but were willing to jump-on it because they were worried about the competition. the fear of out­ side competition among hospitals is the second thing that i find that is still very, very prevalent. there has been a tremendous amount of consolidation in the hospital in­ dustry nationwide. i believe in the past two years alone, our shop has worked on one side or the other of thirty hospital transactions. that is just unprece2007] panel discussion 273 dented deal flow compared to the past few years. as those hospitals come to­ gether, you still have markets where it is the two behemoths or maybe even a third. a lot of times, you will see that the third hospital is willing to take risk. they will do some form of a joint venture, and there will be a competitive re­ sponse. even in this market [indianapolis], there has been somewhat of a com­ petitive response to the joint venture that is put together. still, it is not clear how fast or how much this is going to perpetuate. i think it largely depends upon the region. in the paper that we handed out, you see that some hospitals and health systems are very proactive. we worked with catholic healthcare west to come up with a real methodology to evaluate joint ventures strategically, financially, economically, and operationally, and we have also developed execution guidelines. this is one end of the spectrum. the second end of the spectrum is comprised of the hospitals that have ei­ ther been approached by for-profit enablers, or someone else, and who come to them and say, "by the way, we are doing an ambulatory surgery center and if you play your cards right you can buy in for twenty percent." so those are the two ends of the spectrum that i think that you are seeing. across the country it varies to some degree. on the west coast we are . seeing a fair number of physician practice acquisitions that are much more fi­ nancially disciplined. we are involved in two such acquisitions right now. they have a foundation model in california, which creates a lot more work for lawyers out there, and a lot of documentation, but it is gaining prevalence and the rating agencies are aware of it. not-for-profit hospitals, as you all probably know, are very concerned about their credit rating. they rely on not-for-profit or tax-exempt debt. the rating agencies have announced that they are aware and are watching it, but are not overly concerned about it. i anticipate that you are going to see a fair amount of that going on again, and it is not just in california. we just did one in kentucky as well, so it really is largely across the country. we are also seeing the typical joint ventures that you would imagine, mostly around ambulatory surgery centers, which seem to be far and away the largest segment of joint ventures going on right now. professor blumstein also mentioned these are largely being driven by reimbursement. well, the jury is out on how that is going to go over time. there are a lot of rather innovative structures being employed to keep joint ventured ascs treated as hospital out­ patient departments as hospitals get paid more per surgery than a surgery cen­ ter. there are "under arrangements" and a number of other models that are designed to replicate hospital-based reimbursement in an ambulatory surgery center. it is then, somehow, shared through a joint venture with the physicians. the lawyers on the panel can slaughter my characterization when i am done, but that is largely the purpose of these structures and they are becoming preva­ lent. we are also seeing acquisitions and/or recapitalizations of existing sur­ gery centers. that is a very emotional one because a lot of times these surgery 274 indiana health law review [vol. 4:263 centers have stripped out all the volume that they have from the hospital. after the surgery center owners have distributed everything that they possibly could, they have a lot of dead weight in the ownership structure and so now they want to recapitalize, and they come back to the hospital to do so. we have looked at approximately three of those in the last year and not one got finished. at the end of the day they just could not bring themselves to reward the physicians that had taken that volume ultimately out of their hospital. more of what we are seeing is de novo development, and within that, the hospitals and health systems can be disadvantaged. there are those that are nimble. however, most hospitals like to borrow at an aggregate level because they have tax-exempt debt that they can avail themselves of, but the problem is if you pay cash for everything in an ambulatory surgery center. the returns, effectively to the physicians, can be less because you are not using leverage, and the buy-in can be more as compared to surgery centers facilitated by for­ profit entities. i have been through many of these, where you get down to the end of the day and send out the subscription agreements and ask for checks and it gets really difficult, because physicians are strapped, their incomes are down, and they want to invest in other things but they do not want to take out second mortgages to do so. i don't think that is anything you can blame them for. outpatient imaging is another area that is very hot, but again, there are some proposed changes to reimbursement that make the future uncertain. out­ patient imaging is more dependent upon government reimbursement than out­ patient surgery centers, so there is some concern as to how these ventures will fare in the long term. in this sector we have seen a variety of structures includ­ ing the under arrangements model. we are seeing some joint ventures that are rather interesting and less reac­ tionary, less splitting of what exists and more going after the for-profits. that, from our perspective, is a lot of fun. it typically surrounds labs. the hospitals and larger clinics get together for tests that they actually receive reimbursement for, the real outreach business and going after the quests and lab corps of the world. some have been very successful, even on a super regional and national basis as a not-for-profit doing that. one of the things that we have not really talked about is that, from an exe­ cution standpoint, joint ventures are amazingly complex. there are a lot of days you really prefer just a straight acquisition because in a business combina­ tion only one party survives effectively. in a joint venture there is three times the documentation. there are shareholder agreements, subscription agree­ ments, and joint operating agreements. it is an awful lot more work from in­ volving legal, management, and financial professionals in executing them, and these joint ventures are typically small from a revenue perspective. however, as i think as we have seen in the past, not doing joint ventures properly is very, very dangerous. it will be interesting to see the execution approach hospitals will take. we remain somewhat unclear as to whether joint ventures will be the phy­ sician practice acquisitions counterpart for the 2000s. we just do not know. 2007] panel discussion 275 additionally, it does not take long for reimbursement methodologies and poli­ cies to change. then all of a sudden you have a bad joint venture and the same physicians are increasingly finding themselves pigeonholed and come back to you saying "i want out of this." therefore, saying we are cautiously optimistic is the best way to characterize our position on hospital-physicianjoint ventures. mr. pemberton: thanks, mike finnerty. norm tabler, do you have a reaction to some of mike finnerty's points? mr. tabler: well, i do. i think he made some great points. two things that occurred to me are one, for years and years we thought that the com­ petitive threat was bigger hospitals, combination ofhospitals, mergers and ac­ quisitions, but in virtually every one of the very excellent examples mike gives, you can see that the problem for hospitals is really the opposite of that. the problem is that the business is being divided up into little pieces, some of them quite small. the little pieces are being taken away, whether it is laboratory, radiation, or high profit surgery, but the pieces are being taken away one at a time and that is both the competitive and fmancial threat. it reminds me of something, which took me an embarrassingly long time to figure out. i think that really, the whole american hospital system is built on a theory, or foundation that has started to crumble. the foundation is that health care will be delivered through non-profit general hospitals. that is kind of an unexpressed assumption. i say "general" because there are many lines of business that are back­ breakingly unprofitable, such as the emergency room, but the theory is that all hospitals will be general and will take the bad with the good. i think you can make much the same case, maybe a little less compelling but still pretty com­ pelling, that the theory of our hospital industry is that all hospitals will be non­ profit and will have the same sets of duties and motives. i also think you can make a very compelling case that all structural beams of the hospital industry in america really depend on those assumptions, and they have proved to be falla­ cious. i will give you one example that i think gets much less publicity than it should, and that is the drg system. the drg theory is that there will be a primary diagnosis and that the hos­ pital will get paid a flat fee for that diagnosis. it is just like the guy with a book at the car repair shop. it shows what it ought to cost. that theory is completely dependent on the notion that hospitals will be general hospitals. if a forty-year­ old man who is otherwise healthy has a heart condition, he may be treated at a heart specialty hospital. if he is eighty, has a lot of comorbidities, and his kid­ neys are worn out, the specialty hospital should not and will not admit him. they will send him to a general hospital, but the amount of revenue for the two patients may very well be essentially the same. well, you can see what is going to happen to the general hospital under that sort of program. it surely threatens the drg system, and we cannot con­ tinue to operate under the drg system as it is currently structured if specialty 276 indiana heal til law review [vol. 4:263 hospitals are going to continue to proliferate. question from the audience mr. tabler: the gentleman makes the point that if there are different payers, private versus public, that they will be a difference. that is often true, but it is very often not true, as well. it is true that there are technical adjust­ ments in the hypothetical i mentioned, but my essential point is true. generally, it is much, much more expensive to treat the kind of patients who need a gen­ eral hospital than the kinds of patients who do not need a general hospital. mr. pratt: norm tabler is right. up until very recently, a coronary artery bypass graft paid $72,000. medicare, recently, and in response to the pressure from specialty hospitals, and exactly the phenomenon norm tabler described, said we are going to begin to severely adjust that reimbursement. if you have a cabo (coronary artery bypass graft) surgery with comorbidities and complications, you will get paid $82,000. if you have it without, you will get paid $62,000, or some adjustment of that sort. medicare is responding to the marketplace, as always happens after the fact. they are changing the reimbursement to adjust for the severities, and thus are giving community hospitals greater reimbursements for more severe pa­ tients. while these adjustments have not been made in other areas, they are working on it in orthopedics and those areas where cases are pulled out of the general and into the specialty hospitals. this is a phenomenon you see in health care. whether it is physicians moving into imaging, to which medicare notices, "gee, our imaging bills are climbing dramatically over a period of five years." they then lower the outpa­ tient imaging reimbursement and flatten the freestanding so that it is now com­ parable to hospitals. part of what we do is stay one step ahead of those types of changes, because the government is always watching and once enough informa­ tion comes in, they change how they reimburse. whether it is to reimburse, to decrease reimbursement, to take away incentives, to move it out, or to increase reimbursement for high severity cases, and decrease it for low, it is a constantly evolving process based on the assumptions that norm has described. question from the audience mr. finnerty: i will start offby telling you what we are seeing. then someone with more experience can tell you what they are seeing, and whether or not they perceive it to be good. you know, there were many physician prac­ tice management companies. uson, us oncology, was recently taken private, and it controls something like half, or some ungodly number of the oncologists in the country. pediatrics is one of the few that survived. the practice man­ agement companies that manage simply multi-specialty practices have largely gone away and pediatrics and us oncology, and a handful of other ones are 2007] panel discussion 277 still out there managing contracts. they negotiate on behalf of their physicians, and their ability to leverage up against a hospital, i would leave to somebody else. the second issue that we kind of think of separately is the emergency room doctors, and it certainly feels as though most physicians in the emergency room work for a for-profit company that contracts with hospitals to provide emergency room services, so it's definitely out there. we do not see them very acquisitive any more, but i would like to turn it over to greg pemberton. mr. pemberton: i will talk about the leverage question for a second at least. in the early 1990s, these companies were the darlings ofwall street, and so all they had to do was grow and they could raise more capital. but the model disintegrated because once the management company had managed a physician practice anywhere from three to five years, they would run out of tricks and so they were not really returning the dollars to the physician-workers that used to be the physician-owners that they were before, and to great dissatis­ faction. growth alone and accounting tricks were not enough to keep wall street happy, and so they really hit a wall. phycore was probably the most famous one that hit the wall on all of this. they went away; the whole company pretty much went away. now, the single specialty management companies have somehow weathered this. they are smarter about getting more tricks, or they are better with the accounting, or they are really good at what they do, or some combination thereof, but they seemed to have weathered it, and so that is a reac­ tion from the ground. mr. finnerty: well, we have worked with us oncology too. i mean, that is a practice that depends very highly on equipment very expensive equip­ ment, and so, coming together and doing those services collectively, and pro­ viding kind of that expertise in reimbursement makes sense. again, their physicians are very highly compensated. i think that is really the acid test in all of these things. the other thing i would add to the phycore discussion is that it just put the whole physician community in disarray for years. they were not just buying with cash, they were buying with stock. it just multiplied the ponzi scheme, and so you found a lot of these doctors coming out. a lot of the for-profit hos­ pitals look to not-for-profit hospitals to pick the practices up. it was very, very unsettling for some time. mr. pratt: eleanor kinney, on your question, one of the challenges i face constantly, whether it is in indiana or other states, is exactly at that point. if i am the second guy in town to want to do the deal, the first guy that did it has locked them up with a non-compete that says you will not provide services to, have ownership in, or receive financial compensation from anybody else with whom i compete. it makes it very hard then to build either an equity mod278 indiana health law review [vol. 4:263 el, an ownership model venture, or a contract joint venture type model because many of the doctors are forced to either take on the political risk of violating the non-compete, which they are not loathe to do, but they are afraid to do to some degree, or they cannot do it. i think that is somewhat inconsistent with the the­ ory that underlies the nonprofit community-based hospitals: we are there to serve the community. we certainly have an obligation to remain financially healthy, but i believe that tying up your physicians with non-competes in a way that is good for you, but is not good for the community, is somewhat inconsis­ tent with the· theory behind being tax-exempt. yet this happens all the time, and it is a real·barrier to getting things done. mr. pemberton: we talked on the edge of an issue that i think we can coalesce, and put together yet another model for joint ventures that is short of ownership, and that is a participating bond transaction. this is relatively new to most of us, with the exception of one fellow who we all know pretty well has been peddling these around the country. for those in the audience that have never heard of a participating bond transaction, let me give you the primer on that. it is basically a tax-exempt bond offering which is made on a subordi­ nate basis principally to the physicians who practice at the tax-exempt hospital. through a series of agreements, or compromises, so to speak, the interest on the bonds proves to be somewhat higher than what would ordinarily be a tax­ exempt bond rate. in real numbers, where borrowings between four and five percent are in the market today for a tax-exempt aaa credit, you typically double that inter­ est rate and are up in the eight, nine, and ten percent rate. on a tax-exempt ba­ sis that is pretty attractive when you convert that to what then translates to a taxable return. that is the high level about these transactions, and they are very. complex. mike was talking about costs of joint ventures; well, take this one, two; or three factors beyond that. it is much more cumbersome and challenging from a legal and financial perspective, and it can be very expensive. transac­ tional costs are way out of proportion for the amount of capital that you raise. and that assumes you can maneuver through a couple of fairly thorny legal is­ sues to get there in the first place. mr. finnerty: i would just say that i think we are doing one, and we are the financial advisor to one close by here. a handful of them have been done. one you may know better was challenged unsuccessfully, so it stood. some have been unsuccessful and i believe there was one in louisiana. in or­ der to get through on the physicians' practice office exemption, some have been renting referring physicians both space and time on an imaging machine, such as an mri. i cannot imagine that something which is solely designed to get you around the fraud and abuse is going to last in the long term. i also feel some­ what the same way about the participating bonds. mr. pemberton: excuse me, my apologies. i left out a key point. 2007] panel discussion 279 the reason they are called "participating" is because you only get paid interest if certain performance targets are hit. mr. tabler: additionally, the interest can go up as the targets are ex­ ceeded. mr. pemberton: correct. performance targets are based on fmancial performance, quality, patient satisfaction, and several others. it is actually based on some of the same parameters that dennis pippenger mentioned in the surgery context, only now you apply it to perhaps, the whole hospital operation. therefore, you have physicians who are bond holders and therefore are holders of the debt. this arrangement is attractive to them from a return perspective because they are going to help the hospital perform at the level necessary to hit the desirable targets, thereby enhancing quality. mr. finnerty: typically, we call that equity, not debt. that is the problem. mr. pemberton: that is what the irs is concerned about, whether it is debt or equity. mr. tabler: we talked a lot about physicians as competitors with the hospitals, but ifl had to list the ten biggest threats to our organization, i would say one of them would be the declining income of certain physician specialties. it is a terrible problem for hospitals because, say, we have one ofthe only two level-one trauma centers in the state, and in order to maintain our level-one cer­ tification, we have to have 2417 access to all specialties. there are a lot of spe­ cialties that do not get compensated or reimbursed sufficiently to want to cover a downtown inner-city emergency room 24/7. thus, we are looking for any means within the boundaries of the law to increase the compensation of those physicians. mr. pratt: to give you a real life example of that, when indiana and other states went through this spasm of employing doctors, we were employing primary care doctors straight out of medical school at around $120,000. that was a decade or more ago. i am employing them today for roughly the same amount. physician compensation has been flattened in a way that is very harm­ ful. i am working with one health system that has approached me and said ''we have a sufficient number of primary care doctors in our community, but we will not in ten years because medicare and other payers do not pay enough to keep them in family medicine, or to recruit new people who want to go into family medicine." the hospital views this as a long-term problem for the community and the hospital. they need an adequate base of primary care doctors, and so they want to set up a program that will employ or otherwise subsidize physi­ cians' incomes. 280 indiana heal'ili law review [vol. 4:263 mr. finnerty: in california that is a real problem because the cost of living is so high. it is certainly not the impetus for their foundation model, but it is very beneficial. they can establish a not-for-profit foundation. there are a number of hoops you have to jump through, but once you do, the hospital can then fund that foundation. the reality is the hospital looks at it as an acceptable loss level and then, in that way, they are able to bring physicians into the com­ munity. i was talking to the cfo at cedars-sinai and he stated that while they lose a lot of money, he believes it is more than reasonable because while they are not allowed to look at it, they do make it up in other parts of their business. dr. pippenger: i think that is a really important point when we were interviewing hospital administrators a couple of years ago, we had a fellow from the county just north of san francisco. physicians cannot afford to live there. they had to commute about 100 miles just to come to work because they could not afford to stay in the city. that is just a reality in that area that is not so bad here. truly though, this flat line of physician income has not just af­ fected new grads. it has basically been a problem for almost all physicians, other than a few in certain specialties that have done well because of the things we have talked about. however, the question was ''what does that do to the practice of medicine in the future," and my answer to that is i do not know. the laws and regulations are constantly evolving, and we must move with the changes and challenges. joint ventures are a means of addressing this conun­ drum. while hospitals have been doing seemingly well, physicians have not. the last ten years have been bad for physicians as a whole, and i believe it is becoming more difficult to find a primary care physician due to these issues. mr. pemberton: next topic. let us go back to something that pro­ fessor blumstein mentioned, but not by name. he talked about the gain-sharing arrangements that the federal government is exploring. i want to talk about an­ other federal and also private phenomena that i think we see on the horizon. i think it relates to physician-hospital relationships. i am speaking of the pay-for­ perfonnance phenomena, and the reactions to some of the model programs that the government and some private insurers are doing. will it work? is it a good trend? is there enough money for it to matter? what are your reactions to just the whole pay-for-perfonnance phenomena? mr. tabler: i have to say that it really does frighten me. i do not think of myself as a cynic, but in most of the models that i have studied care­ fully, including some that we got close to executing, i think there is a terrible risk that the perfonnance that you pay for is, by and large, the perfonnance you would have received anyway. let me use a homely example. let us say your office hours for clerical staff are eight to four. what is wrong if you decide to give a bonus to everybody that actually shows up at eight o'clock? well, what is wrong is a lot of people already show up at eight o'clock, and now you are 2007] panel discussion 281 going to pay them bonus for that? i see a profound risk of that in the operation of a hospital. mr. pemberton: other reactions? mr. pratt: i agree. you have to be careful on the criteria you settle upon as a basis for payment. if you look at some of the gain-sharing arrange­ ments that have been approved, they are an attempt to align incentives. an ex­ ample is paying your cardiologist not to open instrument packs unless they are going to use them. the hospital made the case that their surgeons routinely opened instrument packs and often did not use them during the procedure, but it resulted in a $50 or $1 00 cost per pack to the hospital to re-sterilize, reseal, and prepare them for the next procedure. it also meant you have to have more instrument packs available, so more capital is tied up. thus, the hospitals have made the case to the government that they should be able to pay them an incen­ tive not to do that, to change their behavior. whether you should have to pay for that is a legitimate point for debate, but without paying for it, you do not get the behavior you want. i often arrange contractual joint ventures, the purpose of which is to im­ prove some efficiencies and for example, to pay for on-time starts. if you start your first case of the day late, every case of the day is late and you are going run into overtime, which runs into significant staff costs for the hospital. so the question becomes, can we set up a program that rewards doctors for showing up on time? can we reward them for actually using the blocked time that they re­ serve so that we are not in a position that the doctor has the room reserved from eight to eleven? they show up at nine and they do their last case, finishing at 10:15, leaving us with an hour-and-a-half-plus of unused operating room time, staff time and so forth. well, whether we should have to pay for that or not is a debate, but without paying for it, we do not the get the behaviors we want. if there is no reason to behave, you don't get the behavior. i think you have to acknowledge that and move forward with programs like this that will work to change behaviors and create an alignment. mr. pemberton: well, presumably in the public sector, if it is the government pushing pay-for-performance, they can take other laws that might be impacted and sort of sweep them away to make it work. what about the pri­ vate sector? what if a large unnamed health insurer that is headquartered in indianapolis were to put forward a pay-for-performance program and there are legal and ethical concerns? how do you wrestle with those as a physician, a lawyer, or as a business person? mr. pratt: my view is that there are ethical concerns in all of these because you don't want to pay to give the patient less. the purpose should be to provide the care that is needed, but to do so in an efficient manner. there certainly are fewer legal constraints. most of what we struggle with in creating 282 indiana health law review [vol. 4:263 these programs is the restrictions imposed by medicare, cms, or cms patients. i have not really worked through an anthem, united, or sagamore plan like that there would be legal considerations, but i have to say i think it would be much easier if you are only dealing with a set of commercial lives. mr. tabler: we do have, what you might fairly call, pay-for­ performance arrangements with some unnamed gigantic payers here in indian ... apolis. we have enormous amounts of money dependent on meeting certain quality goals. we have not encountered any issues to date. one technical, but i think significant consideration that has to be addressed, which could apply to steve pratt's excellent hypothetical just now, is what about improvements after year one? how do you get better in year two, let alone year three? if you do not get better, do you still give the incentive? dr. pippenger: i think you need to change the incentives to what is appropriate at the time. that is what we do, although we still maintain patient satisfaction as one of. the largest incentives by far. mr. finnerty: but in some senses, is it not a rebasing? that is what a lot of people are concerned about. the buzz on pay-for-performance from cms is that right now it is only a carrot, but pretty soon, it will be a stick. right now you get eighty percent of your compensation if you show up an hour-and-a-halflate for your first surgery, and you get 100% or 110% if you are on time, whatever it happens to be. i wonder if it is just going to be a change in how compensation is done in the future. mr. tabler: one thing i always think about when people bring up the ethical issue, is that it seems funny to nibble around the edges of that ethical issue when, certainly on the procedural side, the physician can decide whether to recommend the procedure and to perform the procedure, and you trust the surgeon to do the right thing. thus, it seems like haggling over pennies to wonder whether the fact that a few extra bucks are dependent on this pay-for­ performance program is ethically offensive. question from the audience mr. tabler:· i really think that the ethical concern raised is exagger­ ated. i think it is the monster under the bed that is not really there. first, put aside the fact that every industry in the united states is operated on the em­ ployment model that is being hypothesized. secondly, remember that if you talk about the physician being an employee of the hospital, then you are asking is there an ethical problem in the fact that this doctor has an indirect financial interest as the employee of the hospital. however, the status quo is that he has a direct financial interest because if he recommends and delivers care, he gets paid directly. we accept that much greater ethical conflict than we do the pro.. 2007] panel discussion 283 posed employment model. question from the audience dr. pippenger: i think the pressure for that [taking into account pay­ for-perfonnance initiatives and reimbursement when making medical decisions] is already there. at least at our hospital, the standard of care would suggest that you always use those measures. if something unfortunate happens and the standards have not been followed, then there are going to be consequences. thus, your decision making is influenced by those kinds of things, and doing what is right i think it becomes pretty clear to you that way. if somebody wants to pay us more for doing what we are already doing, that would be fine. question from the audience mr. pemberton: he has stated that joint ventures appear to be suc­ cessful when there is a predominately private payment source. what happens if in the future, we are at a single-payer system or something along those lines; will joint ventures go away? mr. tabler: well, i think essentially they are equally attractive whether it's a public or private payer. mr. pratt: i do not think they will go away. there is always going to be a need to have the physicians and hospitals working toward the same goal of being efficient in providing quality care, whether that is a single-payer system or the system we have today. mr. pemberton: since it is early in 2007 and next year is an election year, let us talk about health care reform. i think it is fairly likely that health­ care is going to be a huge issue in the presidential election of2008. regardless of what candidate gets nominated and elected, there is going to be dialogue. what kind of fallout would the panelists predict, based upon this spotlight of health care reform that employers, unions, everyone seems to be concerned with today? mr. pratt: well, i'd offer one observation and that is there will cer­ tainly be reform that is designed to reduce costs. mr. tabler: well, i think we are moving inexorably toward a one­ payer system. if you would look at our books, and aggregated medicare and medicaid, you would think essentially we were in a virtual one payment system. i have a suspicion that a fair amount of the public assault on the hospital indus­ try and health care costs from governmental spokesmen is really intended to soften the population up for a one-payer system. 284 indiana health law review [vol. 4:263 mr. pratt: for those of you not in health care, norm tabler said that at clarian it is roughly fifty percent government payment. i think that is fairly typical. forty, to fifty, to sixty percent government revenues are common for a hospital if it is a full-service hospital. mr. tabler: moreover, it is going up, and it would go up even if no changes in the system were made at all because everybody is getting older. as the gentleman who asked the question reminded me, everybody is getting older and thus using more of medicare. additionally, there is a pretty strong phe­ nomenon, although i do not know whether it is permanent or not, but the in­ creasing number of uninsured is another way of saying that we are experiencing an increasing number of medicaid patients. mr. pemberton: many of the reform discussions start with the idea of extending either medicaid on a state level, or medicare on a federal level to other populations. for example, medicaid has the scrip's program and things along those lines,· where you extend the eligibility to cover a larger body of folks, and incrementally get to a single-payer system. mr. finnerty: i remember hillary clinton and ira magaziner getting together to reform health care; probably right when i was getting out of college. the thing that i find interesting is that across the country, states are increas­ ingly going to for-profit companies to manage their medicaid business. we are also seeing a real resurgence in medicare that is being shipped out to for-profit insurance companies. they are even going out now to ppo plans for medicare, so i guess anything is possible. you know, you have basically given them fifty percent of the dollar and they made a mess of it. now they are saying if you give us the whole thing we can really make this work, and i do not know how that is going to fly at the end of the day. mr. pemberton: you wouldn't be a free marketer, by any chance? dr. pippenger: i was rather hopeful that there would be a big debate on that two or three years ago, but i think other things took precedence at that time, so i look forward to that. i hope that that does become the top issue of 2008. i, for one, think the current system is headed toward total disaster and something has to happen sooner rather than later. i think if we had a one-payer system that would simplify things a lot. each company has different forms, and complications arise with everyone using different software, and all in all, it's just a nightmare to work though. i believe it may come down to just a single-payer system, or perhaps a two-tier system, whereby perhaps you have some form of supplemental insur­ ance, but at the very least, everyone would be able to have a doctor or coverage of some type. i think that is where we're headed. 2007] panel discussion 285 mr. tabler: i am not prepared to do it right now, but i think you could make a fairly compelling case that health care is too important for the government not to provide it. that it is so fundamental, it is like police protec­ tion, fire protection, military defense, streets and highways. the only way to do that for everyone in a reasonably effective way is to do it through the govern­ ment. education is another one of those fundamental services. mr. pemberton: once we have a single-payer here in indiana, then we will sell it to somebody from australia. question from the audience mr. pemberton: this is not an answer, but it is one factor to take in­ to account as to what might bring about change, and that is what the health care system is continuing to do to our competitiveness on an international scale. if our workers cannot be insured and we cannot afford their health care, it is caus­ ing prices of our products to continue to go up. that may be finally when the chamber of commerce and the unions all of a sudden hold hands and say, ''this has got to change and congress you got to do it. •• that is when i believe some­ thing is going to happen, when you have everybody that employs somebody saying, it is got to change, and you have got everybody that is employed saying it has got to change. mr. tabler: well, i agree with what the questioner said. i think the system is fundamentally broken and needs a fundamental fix. carrots or candy in corner stores?: federal facilitators and barriers to stocking ileal thier options sheila fleischhacker, phd, ro* & joel gittelsohn, phd, ms** i. introduction •••.•••••.•••••••.•.•••••••••••...•.•••..••••....•••...•••••...••••.•..•.••....•• 24 ll. fiscal facets of federal food aurn:ority •.•.••••.•.•••.•.•.••••.•..••. 30 a. commerce clause ...................................................................... 31 b. taxing and spending power ...................................................... 37 lll. from production to promotion ................................................ 43 a. farm bi/1 .................................................................................... 43 b. healthy food financing initiative ............................................. 45 c. foodsqfety ................................................................................. 41 * sheila fleischhacker is a national institute of health-university of north carolina interdisciplinary obesity post-doctoral fellow. her current research interests include the role of the built environment in childhood obesity and health disparities. specifically, she is working with alice ammerman. kelly evenson, and daniel rodriguez on developing a methodology examining the emergence, employment, effectiveness, and encouragement for policy implication in obesity research articles focused on school-level factors (e.g., walk-to­ school options, school food availability within the lunchroom, school campus, and imme­ diate school neighborhood, and school health policies). sheila is also working with this team, amy ries, and the nc commission on indian affairs. to investigate access to healthy eating in nc american indian communities. in addition, she works with the society for nutrition education, two alliances, and congressional members on 2009 child nutrition reauthorization. this includes various reports, position statements, and bill language. shei­ la received a b.s. and j.d. with a certificate in health law from loyola university chicago and ph.d. in integrative biosciences/nutritional sciences from the pennsylvania state uni­ versity. she has written an array of scientific publications, policy briefs, and law reviews on a range of topics including childhood obesity, health disparities, research ethics, and food safety. her professional experiences include: the government accountability project, ob­ ama for america, rush university medical center office of legal affairs. illinois office of the attorney general environmental division. illinois state board of education nutrition programs, powerbar/nestle, and the american indian housing initiative. she is licensed to practice in illinois. ** joel gittelsohn, phd, msc, associate professor, department of international health, johns hopkins university, is a medical anthropologist who specializes in the use of qualitative and quantitative information to design, implement and evaluate health and nutri­ tion intervention programs. dr. gittelsohn integrates qualitative and quantitative approaches to better understand culture-based beliefs and behaviors regarding dietary patterns, and how these factors influence the success or failure of dietary and lifestyle modification strategies. he applies these methods and interventions for the prevention of obesity and diabetes among different indigenous and ethnic groups, to nutrient deficiencies of nepalese children and women. andto improve infant feeding in diverse settings (the gambia; hartford, ct; peru). he is currently working on chronic disease interventions among the white mountain and san carlos apache (obesity prevention), the ojibwa-cree (diabetes prevention), african american church-going women (cardiovascular disease prevention) and children and adults in the republic of the marshall islands (obesity and undernutrition prevention). he received his b.a. from the university of california at berkley; m.s. from the university of connecti­ cut; and his ph.d. from the university of connecticut. for more information, go to www.healthystores.org. 24 indiana health law review [vol. 7:23 d. child nutrition reauthorization ................................................ 49 e. food marketing ......................................................................... 50 f. nutrition labeling ...................................................................... 51 g. other federal options ............................................................... 51 iv. conclusion ...•••. , ............................................................................ 55 abstract this article examines federal facilitators and barriers to stocking healthier options in the food environment, with particular emphasize on · how healthy foods do (or more often don't) get to smaller grocery stores or "comer stores" in predominantly low-income areas. as this article makes clear, public policy is inextricably woven into the fabric of our food sys­ tems because of its vital role in providing a variety of healthy food options and promoting equal access to healthy foods in all communities across the united states. our article provides brief explanations of past, present, and potential examples, including policies ranging from the commerce clause to the u.s. farm bill to the clayton antitrust act. we focused on laws di­ rectly and indirectly facilitating or impeding a healthy food environment from production to promotion. this article concludes by suggesting the federal government should work with tribal, state, and local governments, along with other corporate and community stakeholders to maximize legal and policy strategies to improve access to healthy foods within all u.s. communities. i. introduction the food environment is a causal factor in the current obesity epidem­ ic, particularly in resource scarce areas. 1 broadly defined, the food and nu­ trition environment includes all potential determinants of what individuals eat except for individual-level "factors, such as cognitions, attitudes, be­ liefs, and skills. "2 at a more local level, the food environment describes food stores (e.g., corner stores, grocery stores, supermarkets, specialty food stores, farmer's markets, and food pantries), restaurants (e.g., fast food and full-service), schools (e.g., cafeterias, vending machines, and snack shops in childcare settings, schools, and colleges), and worksites (e.g., cafeterias, l. robin a. mckinnon. et al., measures of the food environment: a compilation of the literature, 1990-2007,36 am. j. preventive. med. sl24 (2009). 2. karen glanz, measuring food environments: a historical perspective, 36 am. j. preventive med. s93, s93 (2009); see also karen glanz, et al., healthy nutrition envi­ ronments: concepts and measures, 19 am. j. health promot. 330, 331 (2005) (setting forth a conceptual model for the study of nutrition environments based on an ecological model of behavior that incorporates constructs found or hypothesized to be related to the healthy eating outcomes). 2010] carrots or candy in corner stores? 25 vending machines, and snack shops).3 others extend the description of the local food environment beyond the identification and categorization of food outlets to indicators of the availability, accessibility, and affordability of healthy foods, such as the variety of fruits and vegetables, and the exposure to calorie dense foods.4 over the past decade, evidence has increasingly linked the food envi­ ronment to diet quality.5 one of the first food environment studies was the atherosclerosis risk in communities study, with 10,623 socioeconomical­ ly, racially, and geographically diverse participants. in this study, african americans' fruit and vegetable intake increased by thirty-two percent for each additional supermarket in the census tract while caucasians' fruit and vegetable intake increased by eleven percent with the presence of one or more supermarkets.6 another early study investigated the association be­ tween distance to the closest supermarket and quality of diet in 918 preg­ nant women. 7 results showed women living greater than four miles from a supermarket were more than twice as likely to have low dietary quality compared to women living within two miles of a supermarket. 8 similar findings were reported by two studies examining the associations within urban populations.9 while rural settings are less studied10, one investigation focused on a six-county, rural region in texas found neighborhoods were at least 17. 7km from the nearest supermarket, a distance challenging rural res­ idents without public transportation or reliable vehicle access.11 the associations between the food environment and diet quality can be 3. mckinnon, et al., supra note 1, at s124-sl25. 4. kylie ball, anna timperio & david crawford, neighborhood socioeconomic inequalities in food access and affordability, 15 health & place 578, 578-579 (2009). 5. kimberly b. morland & kelly r. evenson, obesity prevalence and the local food environment, 15 health& place 491,491 (2009). 6. kimberly b. morland, et al., the contextual effect of the local food environment on residents' diets: the atherosclerosis risk in communities study, 92 am. j. pub. health 1761, 1761-1767 (2002). 7. barbara a. laraia, et al., proximity of supermarkets is positively associated with diet quality index for pregnancy, 39 j. pr.eventivemeo. 869,869-75 (2004). 8. id. at 872-73 9. shannon n. zenk, et al., neighborhood retail food environment and fruit and vegetable intake in a multiethnic urban population, 23 am. j. health. promot. 255, 25564 (2009) (examining the relationship between the neighborhood food environment and fruit and vegetable intake in 919 multiethnic urban adults and finding the presence of a large gro­ cery store in the neighborhood was associated with 0.69 more daily fruit and vegetable serv­ ings); see also shannon n. zenk, et al., fruit and vegetable intake in african americans: income and store characteristics, 29 am. j. preventive med. 1, 1-9 (2005). 10. see joseph r. sharkey, measuring potential access to food stores and food­ service places in rural areas in the u.s., 36 am. j. preventive med. sl51, s151-55 (2009) (explaining how most of the food environment work focuses on predominantly urban areas instead of rural areas, where the burden of diet-related chronic disease is high). 11. joseph r. sharkey & scott horel, neighborhood socioeconomic deprivation and minority composition are associated with better potential spatial access to the ground­ truthed food environment in a large rural area, 138 j. nutrition 620, 620-627 (2008). 26 indiana health law review [vol. 7:23 traced down to the shelflevel.12 to illustrate, a cross-sectional study of759 baltimore-area participants directly examined the availability of . healthy foods in all food stores within each participant's census tract, specifically within one mile of their residence, and each participant's closest food store.13 based on these examinations, african american participants were more likely to live in neighborhoods with lower availability to healthy foods than the caucasian participants.14 participants living in areas with low availability reported consuming lower-quality diets. 15 in school set­ tings, research similarly demonstrates a healthier food environment leads to healthier dietary patterns among children and adolescents.16 studies have also examined the associations between the food envi­ ronment and health outcomes.17 for example, access to healthier food out­ lets is associated with lower body mass index (''bmf') and lower prevalence of obesity.18 on the other hand, increased access to convenience 12. see elizabeth a. baker, et al., the role of race and poverty in access to foods that enable individuals to adhere to dietary guidelines, 3 preventive chronic dis. l, 1~ 11 (2006) (conducting audits of st. louis, missouri supermarkets and fast food restaurants to examine the location and availability of food choices that enable individuals to meet the u.s. dietary guidelines and finding mixed-race or caucasian high~poverty areas and all african american areas (regardless of income) were less likely than predominantly caucasian neighborhoods to have access to foods that enable individuals to meet the recommended dietary guidelines); and allen cheadle, et al., community-level comparisons between gro~ eery store environment and individual dietary practices, 20 preventive med. 250, 250261 (1991) (reporting the availability of low-fat and high-fiber products in stores is asso­ ciated with the reported healthfulness of individual diets; likewise, the health-education ma­ terial provided by the stores was also associated with the healthfulness of individual diets). 13. manuel franco, et al., availability of healthy foods and dietary patterns: the multi-ethnic study of atherosclerosis, 89 am. j. clinical nutrition 897, 897-904 (2009). 14. id. at 899. 15. id. 16. see simone a. french & gloria stables, environmental interventions to promote vegetable and fruit consumption among youth in school settings, 37 preventive med. 593, 593-610 (2003) (concluding that environmental change interventions in schools may increase fruit and vegetable consumptions among children and adolescents based on a review of the school food environment literature); and dianne neumark-sztainer, et al., school lunch and snacking patterns among high school students: associations with school food environment and policies, 2 int'l. j. behav. nutrition & physical activity 1, 1-7 (2005) (finding student snack purchases at school were significantly associated with the number of snack machines at schools). 17. morland & evenson, supra 5, at 491. 18. see steven cummins & sally macintyre, food environments and obesity­ neighbourhood or nation?, 35 lnt'l. j. epidemology 100, 100-104 (2006) (reviewing the evidence for the influence of food outlets, discussing if where you lives makes you fat, and concluding that the observational evidence in the u.s. tends to support the notion that the local food environment influences healthy eating and weight status, but these associations do not appear to be as strong in international settings); morland & evenson, supra note 5, at 491-495 (investigating the presence of food establishments and obesity among 1295 adults living in the southern region of the u.s. and fmding lower prevalence of obesity in areas with more supermarkets and higher obesity prevalence in areas with more small grocery stores or fast food restaurants); andandrew rundle, et al., neighborhood food environment and walkability predict obesity in new york city, 117 envtl. health perspect. 442, 4422010] carrots or candy in corner stores? 27 stores or smaller grocery stores, which tend to stock less fruits and vegeta­ bles and more processed foods, is associated with higher obesity preva­ lence.19 increased access to fast food restaurants has also been associated with increased obesity f"evalence20; some studies, however, have fotind slight to no associations. 1 · . · ' . ' 447 (2009) (examining the association of neighborhood food environment in new york city with bmi and obesity and reporting that the density of healthy food stores (e.g., supermar­ kets, fruit and vegetable markets, and natural food stores) was inversely associated with bmi and lower prevalence of obesity). 19. morland &.evenson, supra 5, at 491-95; see also irina b. grafova, overweight children: assessing the contribution of the built environment 47 preventive miid. 304, 3()4.:.08 (living in a neighborhood with higher convenience store density is associated with a higher probability of being overweight, based on analyses with 2482 children aged 5'-18). · 20. morland & evenson, supra note 5, at 491-95; and grafova, supra note 19, at 3()4.:. 08; see also shin-yi chon, et al., an economic analysis of adult obesity: results from the behavioral risk factor surveillance system, 23 j. health econ. 565, 565-87 (2004) (em­ ploying the 19s4-i999 behavioral risk factor surveillance system, augmented with state level measures pertaining to the per capita number of fast food and full-service restaurants and reporting large positive effects associated with the per capita number of restaurants); janet currie, et al., the effect of fast food restaurants on obesity, nber working paper series no. 14721 (2009), available at hup:l/www.nber.ol§'papersf wl4721 (last vi­ sited may 15, 2010) (investigating the supply of fast food on three million school children and over one million pregnant women and finding that among ninth grade children, a fast food restaurant within a tenth of a mile of a school is associated with at least a five percent increase in obesity and among pregnant women, a fast food restaurant within a half mile of her residence results in about a two percent increase in the probability of gaining over twenty kilos); fuzhong li, et at., built environment, adiposity, and physical activity in adults aged 5()...75, 35 am. j. preventive med. 38, 38-46 (2008) (finding as the density of.fast food outlets increased so did resident-levels of overweight/obesity rates in a cross-sectional sam­ ple in portland, or); jay maddock, the relationship between obesity and the prevalence of fast food restaurants: state-level analysis, 19 am. j. health promot. 137, 137-43 (2004) (accounting for six percentage of variance in state obesity rates with square miles per fast food restaurants); neil k. mehta & virginia w. chang, weight status and restaurant availability: a multi-level analysis, 34 am. j. preventive med. 127, 127-33 (2008) {ana­ lyzing the relationship between the restaurant environment and weight status across counties in the u.s. and reporting that fast food restaurant density and a higher ratio of fast food to full-service restaurants were associated with higher individual-level weight status while a higher density of full-service restaurants was associated with lower weight status); and may c. wang, et al., changes in neighborhood food store environment food behavior and body mass index, 1981-1990, 11 pub. health nutritlon 963, 963-70 (2007) (increasing number and density of fast food restaurants in four mid-sized cities in agricultural regions of california during 1981-1990; likewise, the obesity prevalence in these communities in­ creased during this period). 21. see hillary l. burdette & robert c. whitaker, neighborhood playgrounds, fast food restaurants, and crime: relationships to overweight in low-income preschool children, 38 preventlve med. 57, 57-63 {2004) {reporting no association between 7,020 low-income children from cincinnati, oh overweight status and their proximity to fast food restaurants); david a. crawford, et al., neighborhood fast food outlets and obesity in children and adults: the clan study, 3 int'l. j. pediatric 0besi1y 249, 249-56 {2008) (providing little support for the relationship between fast food outlets and increased obesity in an australian elementary school children); robert w. jeffery, et al., are fast food res­ taurants an environmental risk factor for obesity?, 3 int'l.l behav. nutritlon & physical actmty 2, 2-7 (2006) (using a telephone survey of 1033 minnesota residents to determine that proximity to fast food restaurants to home or work was not associated with eating at fast food restaurants nor with bmi); russ p. lopez. neighborhood risk factors for 28 indiana health law review [vol. 7:23 lower socioeconomic populations are more at risk for living in un­ healthy food environments.22 that is, supermarkets and gas stations with convenience stores are more prevalent in wealthier neighborhoods than the poorest neighborhoods in a diverse four-state sample.23 fasts food restau­ rants are also more prevalent in low-income neighborhoods.z4 racial dispar­ ities also exist. african american neighborhoods in detroit were over one mile further from the nearest supermarkets than were caucasian neighbor­ hoods.z5 studies have also found african american neighborhoods had more fast food restaurants than caucasian neighborhoods.z6 in a predomi­ nantly low-income, urban latino community, a survey of 251 grocery stores e'bodegas") and 25 supermarkets found low-fat milk available in 73 percent of bodegas and 96 percent of supermarkets; nonetheless, low-fat milk only accounted for 15 percent of total milk volume in bodegas and 37 obesity, 15 0besi1y 2111, 2111-19 (2007) (combining data from the u.s. behavioral risk factor surveillance system with data from the u.s. census and reporting that fast food es­ tablishment density was poorly associated with obesity risk); and roland sturm & ashlesha datar, body mass index in elementary school children, metropolitan area food prices and food outlet density, 119 pub. health 1059, 1059-68 (2005) (reporting no significant af­ fects on bmi changes during a four-year period in a nationally representative sample of kin­ dergarten children in relationship to food outlet density. 22. kimberly morland, et al., neighborhood characteristics associated with the loca­ tion of food stores and food service places, 22 am. j. preventive med. 23, 23-29 (2002). 23. id. at 26-27. 24. see baker, et al., supra note 12, at l-11; jason p. block, et al., fast food, race/ethnicity, and income: a geographic analysis, 27 am. j. preventive med. 211,21117 (2004) (finding in new orleans, la that fast food restaurant density in shopping areas with one-mile buffers was independently correlated with median household income and that predominantly black neighborhoods have 2.4 fast food restaurants per square mile compared to 1.5 restaurants in predominantly white neighborhoods); lisa m. powell, et al., the avail­ ability of fast-food and full-service restaurants in the united states: associations with neighborhood characteristics, 33 am. j. preventive med. 8240, 8240-45 (2007) (examin­ ing associations between local-area racial, ethnic, and income characteristics and the availa­ bility of full-service and fast-food restaurants and finding moderately higher proportions of fast-food among total restaurants in only urban areas, near-low, middle-, and near-high ver­ sus high-income neighborhoods and predominantly black versus white neighborhoods); paul a. simon, et al., proximity to fast food restaurants to schools: do neighborhood income and type of school matter?, 41 preventive med. 284, 284-88 (2008) (noting fast food res­ taurant proximity is inversely related to neighborhood income for schools in the highest commercial areas); and shannon n. zenk & lisa m. powell, us secondary schools and food outlets, 14 health & place 336, 336-46 (2008) (finding schools in the lowest­ income versus the highest-income neighborhoods have more fast food restaurants and con­ venience stores). 25. shannon n. zenk, et al., neighborhood racial composition, neighborhood pover­ ty, and the spatial accessibility of supermarkets in metropolitan detroit, 95 am. j. pub. health 660, 660-67 (2005). 26. see baker, et al., supra note 12, at 1-11; block, et al., supra note 24, at 211-217; maida p. galvez, et al., race and food store availability in an inner-city neighbourhood, 11 pub. health nutrition 623, 624-31 (2007) (examining food store availability in east harlem, new york and finding that african american census blocks had neither supermar­ kets nor grocery stores); and naa oyo a. kwate, et al., inequality in obesigenic environ­ ments: fast food density in new york city, 15 health & place 364, 364-73 (2009) (finding predominantly black areas had higher densities of fast food than predominantly white areas in new york city). 2010j carrots or candy in corner stores? 29 percent of total milk volume in supermarkets?7 another study determined hispanic youth attending u.s. public secondary schools were more likely to attend schools surrounded by convenience stores, restaurants, snack stores, or off-licenses than other race/ethnic groups?8 even though american in­ dians have disproportionate childhood obesity and type 2 diabetes rates,29 no studies (to our knowledge) have assessed the food environment in amer­ ican indian settings.30 insight into american indian access to healthy food is limited to the white mountain, san carlos apache, and navajo nation, which have recently initiated healthy store interventions.31 in order to access a diverse supply of healthy foods, some of these american indian community members traveled as far as thirty to forty minutes off the reser­ vation.32 in spite of the growing evidence-base, work remains on developing 27. howell wechsler, et al., the availability of low-fat milk in an inner-city latino community: implications for nutrition education, 85 am. j. pub. health 1690, 1690-92 (1995); see also joseph r. sharkey, et al., association between neighborhood need and spatial access to food stores and fast food restaurants in neighborhoods of colonias, 8 int'l. j. health geographics 9, 9-25 (2009) (finding in a predominantly hispanic!latino population living in hidalgo county in the lower rio grande valley of texas that residents in neighborhoods with increased deprivation had to travel a significantly greater distance to the nearest supercenter or supermarket, grocery store, mass merchandiser, dollar store, and pharmacy for food items); and roland sturm, disparities in the food environment sur­ rounding us middle and high schools, 122 pub. health 681, 681-90 (2008) [hereinafter sturm, disparities]. 28. sturm, disparities, supra note 27, at 681-690. 29. see sarah e. anderson & robert c. whitaker, prevalence of obesity among us preschool children in different racial and ethnic groups, 163 archives pediatrics adolescent med. 344, 344-48 (2009) (reporting that american indian four-year-old pre­ schoolers endured a childhood obesity prevalence rate that doubled the non-hispanic white and asian mtes and were notably higher than hispanic and non-hispanic black children rates); dana dabelea, et al., diabetes in navajo youth: prevalence, incidence, and clinical characteristics: the search/or diabetes in youth study, 32 diabetes care sl41, s1414 7 (2009) (describing how type 2 diabetes is now a common disease among american indian children over the age of ten); and david s. jones, the persistence of american indian health disparities, 96 am. j. pub. health 2122, 2122-34 (2006) (discussing how american indians have endured health disparities since the first contact with european explorers over five hundred years ago, and these disparities persistence from infancy through adulthood and across a broad spectrum of diseases). 30. joel gittelsohn & sangita sharma, physical, consumer, and social aspects of measuring the food environment among diverse low-income populations, 36 am. j. preventive men. sl61, sl6l (2009). 31. see sarah curmn, et al., process evaluation of a store-based environmental ob­ esity intervention on two american indian reservations, 20 health enuc. res. 719, 71929 (2005); joel gittelsohn, et al., psychosocial determinants of food purchasing and prep­ aration in american indian households, 38 j. nutrition enuc. behav.163, 163-68 (2006); amy e. vastine, et al., formative research and stakeholder participation in intervention development, 29 am. j. health behav. 57, 57-69 (2005); and marla pardila, international health, center for human nutrition, johns hopkins university, et al.; presentation at the !36th american public health association annual meeting: using community workshops to develop a culturally tailored obesity and diabetes intervention program for the navajo nation (oct. 28, 2008). 32. vastine, et al., supra note 31, at 57-69. 30 indiana health law revmw [vol. 7:23 more valid and reliable measures, as well as strengthening the connection between food environment research and policy implications.33 this article aims to address the relevant policy implications of the food environment evidence-base by focusing on the federal facilitators and barriers to stock­ ing healthier options in the food environment. our emphasis is on how healthy foods do (or more often do not) get to smaller grocery stores or "comer stores" in predominantly low-income areas. as this article makes clear, public policy is inextricably woven into the fabric of our food sys­ tems because of its vital role in providing a variety of healthy food options and promoting equal access to healthy foods in all communities across the united states. our article provides brief explanations of past, present, and potential fiscal facets of federal food authority (part 1). we then focus on laws directly and indirectly facilitating or impeding a healthy food envi­ ronment from production to promotion (part ii). this article provides rec­ ommendations for future federal action and concludes (part iii) by suggesting the federal government should work with tribal, state, and lo­ cal 'governments, along with other corporate and community stakeholders to maximize ·legal and policy strategies to improve access to healthy foods within all u.s. communities. ii. fiscal facets of federal food au1hority the federal government has significantly influenced the food envi­ ronment from our initial agricultural society to today's modem global food supply.34 this section focuses on the past, present, and potential of the commerce clause and the taxing and spending power. 33. see leslie a. lytle, measuring the food environment: state of the science, 36 am. j. preventive med. 8134, 8134-44 (2009); brian e. saelens & karen glanz, work group i: measures of the food and physical activity environment: instruments, 36 am. j. preventive med sl66, sl66-70 (2009); stephen a. matthews, et al., work group ii: us­ ing geographic information systems for enhancing research relevant to policy on diet, physical activity, and weight, 36 am. j. preventive men sl71, sl71-76 (2009); j. michael oakes, et al., work group iii: methodologic issues in research on the food and physical activity enviroments: addressing data complexity, 36 am. j. preventive med 8177, 8177-81 (2009); mary story, et al., work group iv: future directions for measures of the food and physical activity environments, 36 am. j. preventive med sl82, 8182-88 (2009); angela m. odoms-young, et al., measuring food availability and access in afri­ can-american communities, 36 am. j. preventive med. sl45, 8145-50 (2009); gittelsohn & sharma, supra note 30, at 8161-65; and joanna e holsten, obesity and the community food environment: a systematic review, 12 pub. health nu1rition 397, 397-405 (2008). 34. lawrence 0. gostin, et al., assessing laws and legal authorities for obesity pre­ vention and control, j. law med. & ern. 28-36 (2009) (putting forth examples of how cur­ rent laws and legal authorities affect obesity prevention and control in both positive and negative ways). 2010] carrots or candy in corner stores? 31 a. commerce clause the constitution enumerates powers to the federal government, pro~ viding the general authority to regulate virtually all economic activities in the nation, including the food environment 35 one of the most important powers is conferred through the commerce clause, which states: "con­ gress shall have the power ... [t]o regulate commerce with foreign nations, among the several states, and with the indian tribes.'.j6 a historical under­ standing of the commerce clause illustrates its long-time connection with agricultural activities, public health, and food safety. 1. history of the commerce clause to begin, the commerce clause was added to the constitution to ena­ ble our nation to regulate foreign commerce and to prohibit states from im­ posing burdens on each other.37 the supreme court initially defined congress' commerce power in 1824 while considering a monopoly granted to a steamboat inventor to exclusively operate his boats on the. hudson riv­ er between new york and new jersey.38 interpreting the language of the commerce clause with the necessary and proper clause39, justice marshall broadly determined that commerce "describes the . commercial intercourse between nations, and parts of nations, in all its branches, and is regulated by prescribing rules for carrying on that intercourse.'..w justice marshall also held congress had the "utmost" power "to prescribe the rule by which commerce is to be governed.,..1 the "sole restraints" on congress were political.42 the court narrowed its view of the commerce clause during the in­ dustrial revolution to leave regulatory matters to the state governments.43 first, the court narrowly defined commerce in united states v. e. c. knight co., 44 the first significant case brought under the sherman anti-trust act dealing with a monopoly over the manufacturing of refined sugar. in this case, the court construed commerce as an event which "succeeds to manu­ facture, and is not a part of it. ,..5 the second step the court took during this 35. see, id. at 30. 36. u.s. const. art. 1, §8, cl 3. 37. the federaust no. 42, at 267-68 (james madison) (clinton rossiter ed. 1961). . 38. gibbons v. ogden, 22 u.s. l (1824). 39. u.s. const. art. 1, §8, cl.18. 40. gibbons v. ogden, 22 u.s. at 189-90. 41. /d. at 196. 42. ld. at 197. 43. erwin chermerinsky, constitutional law 116-120 (aspen law & business 2d ed.2005). 44. 156 u.s. 1 (1895). 45. e. c. knight, 156 u.s. at 12; see also united states v. butler, 297 u.s. 1 (1936); 32 indiana health law review [vol. 7:23 time to limit federal commerce power was to take varying approaches to what constituted commerce "among the states.'.46 one agricultural example during this period is swift & co. v. united states.47 in this case, justice holmes considered a government action under the sherman act alleging price fixing by meat dealers. the dealers argued their business activities were local and beyond congress' power.48 justice holmes cultivated the stream of commerce doctrine to hold: when cattle are sent for sale from a place in one state, with the exception that they will end their tran­ sit, after purchase, in another, and when in effect they do so, with only the interruption necessary to find a purchaser at the stock yards, and when this is a typi­ cal, constantly recurring course, the current thus exist­ ing is a current of commerce among the states, and the purchase of the cattle is a part and incident of such commerce.49 this doctrine was used to limit business with a public interest and es­ sentially only applied to cases dealing with stockyards and grain ex­ changes. 50 during that era, however, this doctrine was not applied to the poultry business. 51 the third and final approach the court used during the industrial rev­ olution to limit federal commerce authority was the tenth amendment.52 this amendment states: "the powers not delegated to the united states by the constitution, nor prohibited by it to the states are reserved to the states respectively, or to the people.''53 during this era, the court protected states' rights and determined that the tenth amendment reserved a zone of activities for exclusive state control.54 earlier however, the court discarter v. carter coal co., 298 u.s. 238 (1936); champlin refining co. v. corporation comm'n, 286 u.s. 210 (1932); utah power & light co. v. pfost, 286 u.s. 165 (1932); oliver iron co. v. lord. 262 u.s. 172; and. coe v. town of errol, 116 u.s. 517 (1886). 46. chermerinsky, supra note 43, at 120-24. 47. 196 u.s. 375 (1905). 48. swift & co., 196 u.s. at 398-399. 49. id. 50. see barry cushman, continuity and change in commerce clause jurisprudence, 55 ark. l. rev. 1009, 1023 (2003). 51. a.l.a. schechter poultry corp. v. united states, 295 u.s. 495 (1935) (holding congress could only regulate matters with a "direct effect" on interstate commerce and, therefore, exceeded its power when attempting to regulate a slaughterhouse engaged in dis­ tribution, not commerce). 52. chermerinsky, supra note 43, at 125-29. 53. u.s. const. amend. x. 54. chermerinsky, supra note 43, at 125; see also hammer v. dagenhart, 247 u.s. 251 (1918) (holding that the federal government's attempt to regulate production by prohibiting transportation in interstate commerce of manufactured goods from a factory em­ ploying children violated state's rights under the tenth amendment and was unconstitution2010] carrots or candy in corner stores? 33 missed a tenth amendment challenge to the federal regulation of interstate shipments of lottery tickets. 55 similar prohibition laws were upheld during this time, often dealing with diseased or dangerous commodities.56 taken together, these three steps striped congress of significant authority to regu­ late key sectors of this young nation's economy, including agriculture, manufacturing, and mining. the great depression began a new era of the court's interpretation of the commerce clause. to illustrate, in nlrb v. jones & laughlin steel corp.,57 justice hughes disregarded the prior "direct effects" approach and considered if the economic activities of the national labor relations act of 1935 were "close and substantial" to commerce.58 the majority of the court found production to be subject to the commerce clause.59 rather than applying formal rules, this decision suggested the court review com­ merce cases on a case-by-case basis. 60 other key decisions overruled the earlier restrictive commerce clause approaches and helped expand con­ gress' power to regulate commerce.61 congress' power to regulate commerce was broadly construed by the court from 1937 until 1992.62 during this period, the court upheld civil rights laws,63 regulatory laws,64 and criminallaws65 despite challenges that al). 55. champion v. ames, 188 u.s. 321 (1903) (finding a difference between regulation and prohibition, the court upheld a federal law prohibiting the interstate transportation of lottery tickets). 56. see, e.g., oregon-wash. r.r. & nav. co. v. washington, 270 u.s. 87 (1926); clark distilling co. v. western md. ry. co., 242 u.s. 311 (1917); hipolite egg co. v. unit­ ed states, 220 u.s. 45 (1911); and. reid v. colarado, 187 u.s. 137 (1902). 57. 301 u.s. 1 (1937). 58. id. at 37. 59. !d. 60. ld. at 37-38. 61. see wickard v. filbum, 317 u.s. 111 (1942) (determining congress had the au­ thority to regulate even one farmer's overproduction of wheat if the cumulative effects of this activity "might reasonably be deemed nationally significant" and exert " a substantial economic effect on interstate commerce"); united states v. wrightwood dairy co., 315 u.s. 110 (1942) (permitting the federal regulation of the price of milk produced and sold intras­ tate, because the price of milk in state would affect the price of, and the commerce in, inter­ state milk); and. united states v. darby, 312 u.s. 100 (194 finding that congress had the authority to regulate the shipment in interstate commerce of lumber manufactured by em­ ployees who either worked too much or were not paid enough, since this productive activity had a substantial effect on commerce). 62. chermerinsky, supra note 43, at 138. 63. see heart of atlanta motel, inc. v. united states, 379 u.s. 241 (1964) (allowing congress to use its power vested under the commerce clause to prohibit a motel business from discriminating against african americans); and katzenbach v. mcclung, sr. and mcclung. jr., 379 u.s. 294 (1964) (finding the commerce clause provides congress author­ ity to prohibit discriminatory activities of retail establishments, including restaurants that imported a significant portion of their food from other states, and noting the power of con­ gress in commerce is "broad and sweeping"). 64. see hodel v. indiana, 452 u.s. 314 (1981) (finding that a law is only unconstitu­ tional under the commerce clause if "there is no rational basis for a congressional finding that the regulated activity affects interstate commerce, or that there is no reasonable connec34 indiana health law review [vol. 7:23 the law was unconstitutional under . the commerce clause. new limits, however, began to emerge in united states v. lopez.66 in lopez, the court considered the constitutionality of the gun-free school zones act of 1990, which made it a federal offense "for any individual knowingly to possess a firearm at a place that the individual knows, or has reasonable cause to be­ lieve, is a school zone.'.67 a senior in high school in san antonio, texas came to school one day carrying a concealed .38 caliber hand-gun and five bullets. 68 . the student was convicted of violating the gun-free school zones act.69 the court reversed this conviction, concluding that the act was a criminal statue and did not regulate economic or commercial activi­ ty. 70 another law struck down as unconstitutional, in spite of overwhelm­ ing support at the state and local levels, was the violence against women act of 1994.71 the court based its decision on three of the four lopez fac­ tors: (1) the law's attempt to address violence against women was not an "economic activity''; (2) the law had no 'jurisdictional element" with an express connection to or effect on commerce; (3) while the congressional findings regarding this act satisfy the third factor of lopez, these findings failed to demonstrate the "substantial effect" between violence against women and commerce.72 these two cases narrowed the scope of the com­ merce power and demonstrated the court's increased scrutiny of congres­ sional attempts to regulate commerce. 2. commerce clause current food environment possibilities using the past to guide today's possibilities, congress seems to still have the power to regulate even a small amount of wheat used for one household. 73 modem trends have opened the door to uncertainty in con­ gress' commerce power while still leaving opportunities for congress to use the commerce clause to remedy social injustices, such as racial discrimina­ tion in placement of food outlets (or lack thereot).74 specifically, the civil rights act of 1964 (title ll) entitled all persons to equal access to any pub­ lic accommodation, including inns, hotel, motels, restaurants, and cafetetion between the regulatory means selected and the asserted ends." !d. at 323-24). 65. perez v. united states, 402 u.s. 146 (1971) (pennitting congress to make a local "loan shark" a criminal for threatening violence to collect money borrowed to a butcher by showing, amongst other congressional findings, that loan sharking was "the second largest source of revenue for organized crimej. 66. 514 u.s. 549 (1995). 67. !d. (quoting 18 u.s.c. §922(q)(1xa) (1990), invalidated by united states v. lopez, 514 u.s. 549 (1995)). 68. !d. at 551. 69. id. at 552. 70. id. at 568. 71. united states v. morrison, 529 u.s. 598 (2000). 72. !d. at 602-603. 73. wickard, 317u.s. at 111. 74. heart of atlanta motel, inc., 319 u.s. at 241; and katzenbach, 319 u.s. at 294. 2010] carrots or candy in corner stores? 35 rias, without racial or religious discrimination if their "operations affect cominerce."75 later, the fair housing law of 1968 was added to prohibit discrimination in the sale, rental, and financing of dwelling and in other housing-related transactions, based on color, national origin, religion, sex, familial status, and disability.76 congress' authority to address sociill in­ equalities ·through its. commerce power has not been extended to regulate the placement of food stores or restaurants. 77 additionill authority to ad­ dress inequillities in the food environment may be provided to the federal government in the civil rights amendments; nevertheless, the courts have defmed these powers very narrowly and may require state action?8 the tenth amendment may limit federal actions attempting to ad­ dress public health issues if deemed to be issues of ''traditional state con­ cem."79 no child left behind illustrates that even education, a traditional state issue, has been increasingly subjected to federill mandates.80 while the framers of the constitution did not intend for the federal government to directly address health, the federal government has the authority to provide for the general welfare and regulate commerce.81 initially, the federill gov­ ernment deillt with communicable diseases through importation oversight.82 then, increasingly through its power to generate revenue, which will be discussed further in section b, the federill government supported the heillth efforts of the state and local governments.83 today, the federal ·govern­ ment is a major purchaser of health care through medicare and partners with states to provide health care to the poor through medicaid. 84 estab­ lished in 1946, the u.s. heillth and human services ("hhs") centers for disease prevention and control ("cdc") has become our nation's principal health agency.85 the cdc cannot issue any mandates or dictate law.86 nonetheless, the. cdc's recommendations influence state public heillth policy, encourage critical state uniformity on key issues, and facilitate cost75. civil rightsactof1964, pub. l. no. 88-352,78 stat. 241 (1964). 76. fair housing act, 42 u.s.c. §3601 (1968). 77. morland et al., supra note 22, at 28. 78. u.s. const. amend. xm, xn, and xv; see also morrison, 529 u.s. at 598; georgia v. mccullom, 505 u.s. 42, 50 (1992); moose lodge no. 107 v. irvis, 407 u.s~ 163, 179 (1972); united states v. guest, 383 u.s. 745 (1966); burton v. wilmington parking authority, 365 u.s. 715 (1961); united states v. harris, 106 u.s. 629 (1883); and civil rights cases, 109 u.s. 3 (1883). 79. lopez, 514 u.s. at 580, 583. 80. no child left behind act of2001, pub. l. no.l07-110, 115 stat 1425 (2001). 81. bernard j. turnock, essentials of public health 74 (jones and bartlett publishers 2007). 82. id. 83. hospital survey and construction act (burton-hill hospital survey & construc­ tion act, or hill-burton act), pub. l. no. 79-725,60 stat 1040 (1946). 84. social security amendments of 1965, pub. l. no. 89-97, 79 stat 286 (1965). 85. centers for disease control and prevention, our history our story, http:// www.cdc.gov/aboutlhistory/ourstory.htm (last visited june 9, 2009). 86. u.s. const. amend. x. 36 indiana health law review [vol. 7:23 effective and efficient state flexibility. 87 of equal importance, the federal government through the u.s. de­ partment of agriculture ("usda") national school lunch program (''nslp") provides assistance to meal programs administered by states of­ fering low-cost or free lunches to more than thirty million children each school day.88 the nslp was enacted in 1946 "as a measure of national security, to safeguard the health and well-being of the nation's children and encourage the domestic consumption of nutritious agricultural commodities and other foods."89 participation in the federal government's food stamp program, now known as the usda supplemental nutrition assistance pro­ gram ("snap"), reached an all-time (non-disaster) high of twenty-nine mil­ lion people per month in 2008.90 through the usda special supplemental nutrition for women, infants, and children ("wic"), the federal govern~ ment also provides nutritious foods, nutrition education, and referrals to health and other social services to low-income pregnant, postpartum, and breastfeeding women, along with low-income or nutritionally at-risk infants and children up to age five.91 wic currently serves over nine million people each month.92 collectively, these investments illustrate the federal government's increasing role and important state partnerships in our na­ tion's food, nutrition, and health issues. good food, nutrition, and health, individually and collectively, are fundamental to this country's general wel­ fare. to successfully craft legislation capable of facilitating the production and promotion of healthy foods in the u.s. and addressing inequalities in the local food environment among u.s. communities, congress should ex­ plicitly develop regulatory efforts to deal with the economic and commer­ cial aspects of our food systems. for instance, congress could establish laws to regulate the conservation of agricultural land. 93 these attempts to regulate (e.g., requiring minimal standards for the percentage of healthy foods at urban comer stores or small rural stores that are fresh fruits and 87. centers for disease control and prevention, supra note 85. 88. united states department of agriculture food and nutrition service, national school lunch program, http:/lwww.fus.usda.gov/ajdllimcb/about:lunch/nslpfactsheet.pdf (last visited june 9, 2009). 89. the richard b. russell national school lunch act of 1946, 42 u.s.c. §1751 (1946). 90. united states department of agriculture food and nutrition service, supplemen­ tal nutrition assistance program (snap): a short history of snap, http://www.fus.usda.gov/ fsp/rules/legislation/about.htm (last visited june 9, 2009). 91. united states department of agriculture food and nutrition service, nutrition program facts: the special supplemental nutrition program for women, infants, and children, http://www.fns.usda.gov/wic/wic-fact-sheet.pdf(last visited june 13, 2009). 92. id. 93. jamie harvie, et al., a new healthcare prevention agenda?: sustainable food procurement and agricultural policy, 4 j. hunger & envrl. nununon 409, 419-23 (2009). 2010] carrots or candy in corner stores? 37 vegetables) or prohibit (e.g., mandating the reduction of pesticide use) should expressly connect the regulatory endeavor to direct agricultural eco­ nomic activities. although possibly construed as an indirect effect, congress should demonstrate in its congressional findings the increasingly correlated effects of unhealthy food system processes and inequalities in our food systems on the health of the u.s. population-from senior citizens to infants. one re­ levant usda finding suggests the u.s. production of fruits and vegetables is insufficient to supply the amount necessary for every american to meet the dietary guidelines for americans.94 another finding that could be ex­ plicitly detailed is u.s. spending on health care, which is estimated at more than two trillion dollars a year.95 the amount of federal funding a state receives has been shown to impact the number of obesity prevention policy initiatives a state implements.'x1iealth also has significant economic im­ pacts on worker productivity: an estimated eighteen million adults were not working in 2003 due to disability, chronic disease, or another health issue.97 congress should proceed cautiously in justifying its actions based on health care costs and lost worker productivity, since these costs may be viewed by a restrictive court as too indirect to permit a nexus between the regulation and commerce. 3. concluding points on the commerce clause hence, the commerce clause is the federal government's most po­ werful tool to improve access to healthy foods. congress' commerce power has a solid foundation for facilitating the enactment of laws that address dangerous, diseased, and disparate business processes affecting interstate commerce and have the potential to promote our country's general welfare. b. taxing and spending power the tax and spend clause contains other enumerated powers the fed­ eral government has used to regulate the food environment and can poten94. jean c. buzby, et al., usda economic res. serv •• possmle impucations for u.s. agriculture from adoption of select dffitary guideunes (2006), available at http://www.ers.usda.gov/publications/err311 (last visited june 9, 2009). 95. u.s. department of health and human services, agency for healthcare research and quauty, national healthcare quauty report 7 (2008), available at http://www.ahrq.gov/quallnhqr081nhqr08.pdf (last visited june 9, 2009). 96. james hersey, et al., the association between funding for statewide programs and enactment of obesity legislation, 42 j. nutrition eouc. &behav. 54, 51-56 (2010). 97. karen davis, et al., the commonwealth fund, health and productivity among u.s. workers (2005), available at http://www.commonwealthfi.mdorglusr...:.docl 856_davis_hlt_productivity_usworkers.pdf(last visited june 9, 2009). 38 indiana health law review [vol. 7:23 tially apply further.98 the constitution states: "congress shall have power to lay and collect taxes, duties, imposts, and excises, to pay the debts and provide for the common defense and general welfare of the united states; but all duties, imposts, and excises shall be uniform throughout the united states.''99 the tax must provide for a common defense and general welfare; yet this condition is not usually a major hurdle since the courts give great deference to congress ''unless the choice is clearly wrong, a dis­ play of arbitrary power, not an exercise ofjudgment."100 the term "general welfare" is flexible and can adopt to meet current country needs and cir­ cumstances. 101 i. the power to tax congress has used its tax power for a variety of reasons, including protecting american business interests from foreign competitors. 102 unless there is an extreme abuse of power, congress' motive is generally not a cause for striking down a tax, even if it imposes a steeper tax on margarine colored to resemble butter than on uncolored margarine. 103 nonetheless, congress cannot use its tax power to regulate an activity it could not other­ wise regulate. 104 for example, congress tried to employ taxes on the profits of employers using child labor after they failed to curtail the issue through the commerce clause.105 the court struck down this tax as invalid given the improper motive. 106 likewise, the court did not permit congress to use taxes to regulate agricultural production-an activity within the reserved powers of the states.107 the court reached this decision based on con­ gress' inappropriate objectives, not because it was a tax for the general wel­ fare.108 later decisions have followed mccray's deferential approach.109 in more recent years, the court has permitted congress to use taxes to regulate or suppress undesirable activities outside its direct authority, such as the sale of marijuana110 and local gambling111• the tax, however, cannot vi98. u.s. const. art. 1, §8, cl. 1. 99. id. 100. helvingv. davis, 301 u.s. 619,640(1937). 101. ld at 641. 102. see j.w. hampton, jr. & co. v. united states, 276 u.s. 394 (1928). 103. mccray v. united states, 195 u.s. 27 {1904). 104. bailey v. drexel furniture co., 259 u.s. 20 (1922). 105. ld. at 34-35. 106. !d. at 36-44. 107. united states v. butler, 297 u.s. l (1936) (striking down as unconstitutional the agricultural adjustment act, 1933, which allowed the secretary of agriculture to limit the production of certain crops and impose taxes on the production in excess of these limits, as well as authorized grants to farmers to control production as a means of regulating prices). 108. ld. 109. see, e.g., sonzinsk:y v. united states, 300 u.s. 506 (1937) (upholding excise taxes that might have a regulatory effect). 110. united states v. sanchez, 340 u.s. 42 (1950). 2010] carrots or candy in corner stores? 39 olate other constitutional rights.112 2. the power to spend the tax and spending clause noted above not only confers the power to tax, but also grants the power to spend. 113 as seen before, the court de­ fers to congress' determinations on how to spend the country's purse to provide for a common defense and general welfare.114 like taxes, congress is permitted to financially support actions congress cannot directly regu­ late. 115 congress can also condition or place strings on its grants to state and local governments, including in areas congress might not otherwise be able to regulate, if the conditions are expressly stated and are reasonably connected to the purpose of the spending program. 116 for instance, con­ gress successfully attached to transportation funds the condition that the funds could only be received by states that prohibited the purchase or pub­ lic possession of any alcoholic beverage to individuals who were less than twenty-one years of age. 117 the court noted the "financial inducement" in this case was a mere five percent and, therefore, was too small to have a coercive effect. 118 congress has the authority to selectively use its funds to encourage or discourage certain activities.119 the court further determined the spending clause granted congress the authority to protect federal funds from bribery of state and local officials.120 3. taxing sugary drinks recently, u.s. senators have been considering taxing sugary drinks to generate revenue for our nation's health care system. 121 a recent kaiser 111. united states v. kahriger, 345 u.s. 22 (1953). 112. see leary v. united states, 395 u.s. 6 (1969) (finding congress' attempt to use its taxing power to compel self-incrimination violated the fifth amendment); and grosjean v. american press co., 297 u.s. 233 (1936) (striking down a tax on newspaper since it violated the first amendment right to the freedom of the press). 113. u.s. const. art. 1, §8, cl. 1. 114. see south dakota v. dole, 483 u.s. 203, 207 (1987); buckley v. valeo, 424 u.s. 1, 90 (1976); and helvering, 301 u.s. at 640. 115. butler, 297 u.s. at 65-66. 116. compare oklahoma v. u.s. civil service commission, 330 u.s. 127 (1947) (per­ mitting provision of the federal hatch act that granted funds to states on the condition that a civil service program was adopted and limitations were imposed on the political activities of certain government workers); with pennhurst state school and hospital v. halderman, 451 u.s. 1 (1981) (finding that congress' attempt to deny a state federal grant program funds because it violated an ambiguous condition is unconstitutional). 117. dole, 483 u.s. at 203. 118. id. at21l. 119. see, e.g, rust v. sullivan, 500 u.s. 173 (1991) (determining that a regulation for­ bidding doctors in federally funded family-planning facilities from providing abortion coun­ seling did not violate the doctors' first amendment rights). 120. sabri v. united states, 541 u.s. 600 (2004). 121. editorial, a healthy tax, n.y. times, june 3, 2009, at a26, available at 40 indiana health law review [vol. 7:23 family foundation report found the majority of americans support taxes on unhealthy items or "sin taxes", especially if used to raise money for health care and prevention.122 each year, americans spend over "$50 billon a year on nondiet sodas.123 evidence suggests soft drink consumption is as­ sociated with increased energy intake, body weight, and risk for type 2 di­ abetes, along with decreased intakes of milk and calcium, amongst other nutrients.124 taxes have been successfully levied on tobacco and alcohol, which played a role in reducing purchases and generating revenue to ad­ dress these two public health issues.125 in the case of soda drinks, one study estimated that, for every ten percent increase in the price of soda drinks, consumption decreases by about eight percent.126 a penny-per­ ounce excise tax in new york was estimated to generate over one billion dollars. 127 several states, including arkansas, have already i~osed excise taxes or sales taxes on sugared beverages and/or snack foods. a january 2007 report noted tax approaches at the state level varied by retail location (e.g., grocery store vs. vending machine) and by products (e.g., soft drinks vs. snack foods). 129 states tended to tax vended snacks and soft drinks more http://www.nytimes.com/2009/06/03/opinion/03weds3.html (last visited mar. 5, 2010). 122. kaiser family foundation, kaiser health tracking poll: public opinion on health care issues, april 2009, http://www.kff.org/kaiserpolls/upload/7891.pdf (last visited june 10, 2009). 123. editorial, supra note 121. 124. lenny r. vartanian, eta!., effects of soft drink consumption on nutrition and health: a systematic review and meta-analysis, 97 am. j. pub. health 667, 667-75 (2007). 125. see christopher carpenter & phillp j. cook, cigarette taxes and youth smoking: new evidence from national. state, and local youth risk behavior surveys, 27 j. health econ. 287, 287-99 (2008) (reviewing national data from the 1991 to 2005 waves of the youth risk behavior surveys, including state and local field survey results, and finding that the large state tobacco tax increases of the past 15 years were associated with significant reductions in smoking participation and frequent smoking by youths); philip decicca, et al., cigarette taxes and the transition from youth to adult smoking: smoking initiation, cessa­ tion, and participation, 27 j. health econ. 904, 904-17 (2009) (using data from the 1992 wave of the national education longitudinal study to report no evidence that higher taxes prevent smoking initiation, but some evidence that higher taxes are associated with increased cessation); and alexander c. wagenaar, et at., effects of beverage alcohol price and tax levels on drinking: a meta-analysis of 1003 estimates from 112 studies, 104 addiction 179, 179-90 (2009) (reviewing the literature to determine that alcohol prices and taxes are related inversely to drinking). 126. kelly d. brownell & thomas r. frieden, ounces of prevention-the public poli­ cy case for taxes on sugared beverages, 360 new eng. j. med. 1805, 1806 (2009). 127. id. 128. compare brownell & frieden, supra note 126, at 1805 (notes 40 states tax sugary drinks or snacks); with jason m. fletcher, et al., can soft drink taxes reduce population weight? (2008), available at http://www.economics.emory.edu/working_papers/wp/2008wp/ frisvold_08_08_paper.pdf(last visited june 10, 2009) (discussing how "[n]early two-thirds of all states currently tax soft drinks using excise taxes, sales taxes, or special exemptions to food exemptions from sales taxes to reduce consumption of this product, raise revenue, and improve public health"). 129. jamie f. chriqui, et al., state sales tax rates for soft drinks and snacks sold through grocery stores and vending machines, 29 j. pub. health pol'y 226, 226-49 2010] carrots or candy in corner stores? 41 aggressively than grocery items. products; such as soft drinks, candy, and gum, were taxed higher than other foods and beverages. 130 yet, new york set aside an eighteen percent tax on sugary drinks after lobbyists claimed the tax would unfairly burden low-income families. 131 others oppose tax­ ing soda or ''junk food" for various reasons: people must eat, one category of food should not be singled out as bad, government should stay out of private behavior, and makin~ certain foods more expensive will not signifi­ cantly reduce obesity rates. 1 2 richard postner, judge on the united states court of appeals for the seventh circuit, discussed a variety of tax ap­ proaches relevant to obesity and suggested these tax approaches might be more expensive to enforce than effective at reducing obesity. 133 despite this opposition, the federal government could tax unhealthy foods and beverages to deter consumption and generate revenue for health care and prevention. in order to be successful, congress should ensure the tax does not unfairly burden any group of americans nor make eating a healthy diet unaffordable for any americans. the food and/or beverage categories taxed should be clearly defined and chosen based on strong evi­ dence linking them to poor health outcomes. caution should be given to not unduly burden one industry and efforts should be made to discuss feasi­ ble strategies with affected industries. the federal tax should be shared equally across the states. alternatively or in addition, the government could consider taxing food outlets with a high ratio of unhealthy to healthy items available in their stores. taxes might be considered on harmful pro­ duction practices or corporations that heavily market foods of lower­ nutrient quality. the threat of these taxes or the taxes themselves may en­ courage product reformulation. the federal government could also oral­ ternatively reduce income taxes imposed on corporations, farms, comer stores, or restaurants meeting certain benchmarks, such as distributing healthy products at a loss to corner stores or serving fresh fruits and vegeta­ bles with each of their main entrees. 4. tax revenues if the federal government imposed any form of these taxes, the funds generated should feed directly back into improving our food environment. a number of worthy initiatives could benefit from federal support, includ(2008). 130. id. 131. editorial, supra note 121. 132. yale universi1y rudd center for food policy and obesity, soft drink taxes, a policy brief, 6 (2009), available at http://www.yaleruddcenter.orglresourceslupload/ docs/what'reports/ruddreportsoftdrinktaxmay2009.pdf(last visited june 8, 2009). 133. tomas philipson & richard posner, is the obesity epidemic a public health problem? a decade of research on the economics of obesity, nber working paper series no. 14010, 7-8 (2008), available at http://www.nber.org/papers/wl4010.pdf (last visited october 15, 2009). 42 indiana health law review [vol. 7:23 ing: fanner's markets, fannstands, community-supported agriculture fanns, small and mid-sized fanns, and urban fanns. 134 the government should also consider using these funds to create incentive programs. 135 for in­ stance, incentives and/or competitive matching programs may help: (1) corporations and fanners develop creative, cost-effective ways to increase access to healthy foods, such as fruits and vegetables, in low-income com­ munities; (2) growers produce more healthful products and use more sus­ tainable production methods; (3) retailers change the profile of unhealthy to healthy foods available on their shelves and· to purchase equipment and promotional materials necessary to purchase and sell healthy foods; (4) smaller stores to collaborate and invest in regional distribution systems that will allow for off-site storage and easy access to fresh fruits and vegetables ~d low-fat dairy products; (5) local and state governments work with local stores and corporations to create local and regional infrastructural sys­ tems to facilitate the year-round distribution of healthy foods; ( 6) the crea­ tion and further coordination between and among local; state, tribal, regional, national, and global food policy councils; and (7) educational loan repayment programs geared towards professionals who have committed at least two years to improving food access in at-risk communities-whether on the farm, at a fanner's market, or in a local corner store!36 likewise, congress could consider anyone of these examples or others and establish related conditions (e.g., benchmarks for the ratio of healthy to unhealthy foods on comer store shelves or percent of production focused on healthy foods using sustainable practices) on which the local or state public or pri­ vate entity would have to meet in order to receive funding. food environment research should receive a consistent, annual alloca­ tion and have flexible funding cycles able to support evaluations of natural­ ly evolving environmental and policy changes. some examples of questions meriting attention include: (1) what are the most cost-economic approaches in the short and long term to distribute fruits and vegetables to smaller comers stores in urban settings and to smaller grocery or conveni­ ence stores in rural settings, and, if and how, can federal technical assis­ tance improve access to healthy foods in comer stores; (2) what are the relationships between crop prices, food prices, food consumption, and health outcomes and how does socioeconomic status, racelethnicity, and geography factor into these relationships; (3) what are the most effective strategies to ensure both usda and hhs align to advance food, nutrition, and health goals to promote healthy americans in all communities; for in­ stance, ensuring government agricultural support complements u.s. dietary 134. harvie, et al., supra note 93, at419-23. 135. id. 136. david wallinga. et al., considering the contribution of us agricultural policy to the obesity epidemic: ovenliew and opportunities, 4 j. hunger & envrl. nutrition 3, 13-16 (2009). 2010] carrots or candy in corner stores? 43 guidelines; (4) what "best practices" or adoptions to federal food .assis~ tance ·programs, such as snap, will enable the government throughout the month to help support the production, purchase; and consumption ·of healthy foods; and (5) what are the most effective strategies for disseminat­ ing food environment assessments and possible evidence-based solutions to policymakers, communities, and public health and food systems profession­ als in public and private sectorsj37 5. summarizing the potential oft ax and spend powers on the us. food· system therefore, the tax and spend clause permits great latitude for con­ gress to consider how to raise and spend funds related to improving the u.s. food system. if new taxes are imposed on the food system, measures should be put in place to ensure tax revenues are spent to promote healthy eating and improve our nation's food systems. ill. from production to promotion this section highlights the federal legal and policy strategies with greatest impact on the food environment from production to promotion. in addition, this section explains barriers that have hindered the enactment of legal and policy strategies or could potentially present obstacles to using certain strategies to improve access to healthy foods across all u.s. com .. munities. a. farmbill the u.s. farm bill is the most significant bill relating to agriculture production and food distribution.138 originally authorized in 1949, the farm bill pulls together a range of separate laws relating to agriculture, al­ though not all (e.g., immigration).139 these bills are categorized under the following titles: farm payments, agricultural trade, conservation, food as­ sistance, agricultural production, credit, rural development, and research 137. ld. at 13-16; see also healtiiy eating active living convergence par1nership, promising s'irategies for creating healtiiy eating and active living environments, (2008), available at btlp:/!www.coovergencepal1.org/atf7ct7 % 7b245a9b44-6ded4abd-a392-ae583809e3soo/o7d/cp _ promising0fcl20strategies _printed.pdf (last visited may 15, 2010); and karen glanz & amy yaroch, strategies for increasing fruit and vegetable intake in grocery stores and communities: policy, pricing, and environmental change, 39 preventive med. s75, s75-80 (2004). 138. geoffrey s. becker, crs report for congress: the "farm bill" in brief (2006). 139. id. at 2-3. 44 indiana heal til law review [vol. 7:23 and education.140 in 2008, the most recent farm bill was authorized, containing agricul­ tural subsidies for foods, such as milk and beet sugar, but not for fresh fruits and vegetables.141 the bill also appropriated $500,000 for a study on food deserts, defined in the bill as .. an area in the united states with limited access to affordable and nutritious foods, particularly such an area com­ posed of predominantly lower-income neighborhoods and communities."142 in june 2009, a report was released explaining a small percentage of con­ sumers are constrained in their ability to access affordable nutritious foods. 143 in urban settings, areas with limited access tended to be racially and economically segregated.144 rural areas lacked transportation infra­ structure to support easy access to affordable, nutritious food sources. 145 the report noted easy access to all foods is important to understanding the growing obesity epidemic, not just limited access to specific healthy foods.146 a number of other provisions in the farm bill aim to increase access to healthy foods, particularly in low-income and ethnic minority communi­ ties.147 as one example, the 2008 farm bill expanded the usda fresh 140. /d. 141. food, conservation, and energy act of2008, pub. l. no. 110-234, §§1501 and 1401, 122 stat. 923, 990 and 977 (2008) (enacted to provide the continuation of agricultural programs through fiscal year 2012, amongst other purposes). 142. /d. at §7527, 122 stat. at 1277-78 (stating that the secretary of agriculture is to coordinate and consult with the secretary of health and human services, the administrator of the small business administration, the institute of medicine, and representatives of ap­ propriate businesses, academic institutions, and non-profit and faith-based organizations the food desert report shall: (1) assess the incidence and prevalence of food deserts; (2) identify-(a) characteristics and factors causing and in­ fluencing food deserts; and (b) the effect on local populations of limited access to affordable and nutritious foods; and (3) provide recommenda­ tions for addressing the causes and effects of food deserts through meas­ ures that include--(a) community and economic development initiatives; (b) incentives for retail food market development, including supermarkets, small grocery stores, and farmer's markets; and (c) im­ provements to federal food assistance and nutrition education pro­ grams[;] and the report should be submitted to congress not later than 1 year after the date of the enactment of this act). 143. united states department of agricul1ure, access to affordable nutritious food: measuring and understanding food deserts and their consequences (2009), available at http://www.ers.usda.gov/publications/ap/ap036/ ap036.pdf(last visited october 16, 2009). 144. id at 39-47. 145. id 146. id. at47. 147. northeast-midwest institute, "local" foods initiatives in the food, conservation, and energy act of2008, http://www.nemw.org (last visited june 8, 2009) (listing the follow­ ing provisions as initiatives to increase access to local foods, especially in at-risk communi­ ties: local preference for school food purchases, allowing schools the ability to specify 2010] carrots or candy in corner stores? 45 fruit and vegetable snack program in schools, which may help reduce par­ ticipants' purchases at corner stores after school.148 changes were also made making it easier for schools to procure local foods, which may indi­ rectly increase other local food venues access to local products.149 . findings from the food desert study and evaluations of the recent changes enacted will hopefully shape the next reauthorization of the farm bill, including alternative approaches to subsidies, and support further actions to improve the u.s. food system from farm to fork. b. healthy food financing initiatives the current president and his administration, along with the first la­ dy have launched a number of activities to improve access to healthy eating in america, ranging from a presidential task force on childhood obesi­ ty150 to the first lady's let's move campaign.151 the most aggressive ef"local" as a bid requirement(§4302); fanners' market promotion program. providing "up to $75,000 to promote farmers' markets" (§10106); financing for local food enterprises, "es­ tablish[ing] a prioritized pathway for entities involved in local food distribution and market­ ing to secure private-secure loans backed by a usda loan guarantee"( §6015); healthy urban food enterprise development center, "establish[ing] a center within cooperatives state, education, extension, and research service to provide outreach, technical assistance, and feasibility study grants to support the development of enterprises which distribute and market healthy and locally produced foods to underserved urban, rural, and [t]ribal com­ munities" (§4402(2)); community food projects, matching "one-time, fifty percent grants ... for community-based organizations to develop innovative solutions to address" food access issues, amongst other things (§§4402(1) & 4406(ax7)); value-added agricultural market development program grants, continuing the existing "program with a priority for value-chains which market and distribute locally produced food and agricultural products" (§6202); senior fanners market nutrition progrants, expanding funds to "allow currently unfunded [s]tates and [t]ribes to participate [and t]o increase benefits to existing partici­ pants (§§4231 & 4406(cxi)); organic conversion, technical, and education assistance, establishing allowance for "organic practices and the conversation of organic production practices as ... eligible ... under the eqip conservation program" (§2503 under §1204b(i)); rural micro-enterprise assistance program, establishing assistance for ''rural entrepreneurs in establishing new small businesses in rural sectors" (§6022); and farmland protection pro­ gram, increasing funding over five years (§2401)). 148. food, conservation, and energy act of2008, §19 (2008) (amending the richard russell national school lunch act by permanently authorizing the fresh fruit and vegeta­ ble program nationwide, consolidating all prior operations under section 19, and increasing program funding). 149. food, conservation, and energy act of 2008, §4302 (2008); and memorandum from u.s. dept. of agriculture food & nutrition service to all regional directors of special nutrition programs and all state directors of child nutrition progrants (nov. 13, 2008) (on file with indiana health law review), available at hup:/lwww.fus.usda.gov/cndlgovernance/ policy-memos/2010/sp _08_cacfp _os_sfsp _06-2010_os.pdf(last visited may 15, 2010). 150. the white house, office of1he press secretary, presidential memorandum-eslablishing a task force on childhood obesity (feb. 9, 2010), available at hup:/!www.whitehouse.gov/ the­ press-o:fficelpresidential-memorandujn.eslishing-a-task-force.childhood-obesity (last visited jun. 13,2010). 151. first lady michelle obama, let's move: america's move to raise a healthier generation of kids (feb. 9, 2010), available at http://www.letsmove.gov/ (last visited jun. 13, 2010). indiana health law review [vol. 7:23 fort to date specifically targeting limited access to healthy food is an over $400 million healthy food financing initiative.152 part of the· president's budget for 2011, the healthy food.financing initiative supports grocery stores and other healthy food retailers to operate in under-served urban and rural communities.153 equipping existing stores to sell healthy foods is part of the initiative.154 job creation is also a component. 155 local programs, such as' in philadelphia, pennsylvania, and state initiatives, like those in minnesota and lllinois, informed this new federal investment. president obama hopes financial and technical assistance from this u.s. departments of treasury, agriculture, and health and human services endeavor spark creative ways of increasing access to healthy foods in underserved com­ munities from the private, non-for-profit, and other community develop­ ment sectors.156 another example of how usda supports the flow of healthy, affordable foods into underserved areas is the healthy urban food enterprise development center ("hufed"), which provides grants and technical assistance for entrepreneurs and communities.157 recently, thir­ teen finalists were selected for grants out of a pool of 538 letters of inter­ est.158 in congress, the national fresh food financing initiative is garnering bi-partisan support and has been sent to the house subcommittee on rural development, biotechnology, specialty crops, and foreign agri­ culture for review to similarly support efforts from the private and non-for­ profit sectors to open healthy food retail outlets in underserved commtmi­ ties.159 these financing initiatives illustrate how the federal government can stimulate interest in using public-private-non-for-profit partnerships to in­ crease access to healthy foods in underserved communities through grant programs and technical assistance. learning from successful local and state programs and policies, the federal government has started to demon­ strate leadership in this area and help disseminate healthy food financing 152. press release, u.s. treasury department. office ofpublic affaifs, obama admin­ istration details healthy food financing initiative (feb. 19, 2010), available at http://www.hhs.gov/news/press/2010pres/02/20100219a.html qast visited jun. 13, 2010). 153. ld 154. ld. 155. ld 156. ld. · 157. wallace center winrock international, healthy urban food enterprise develop­ ment center, available at http://www. wallacecenter.orglour-work/current-initiatives/healthy­ urban-food-enterprise-development-center qast visited jun. 13, 201 0). 158. ld. 159. recognizing the potential for a national ftesh food financing initiative to provide an. effective and economically sustainable solution to the problem of limited access to healthy foods in underserved urban, suburban, and rural low-income communities, while also improving health and stimulating local economic development, h.res.975 i 11th cong. (2009). 2010] carrots or candy in corner stores? 47 . initiatives throughout this country. special attention is needed to ensure urban comer stores and smaller rural grocery stores benefit from these initi­ atives. grants can help support the purchase and implementation of equip­ ment and distribution networks to bring healthy, affordable foods to these smaller outlets while technical assistance can help disseminate successful promotion and pricing strategies. building and equipping outlets is an im­ portant step to improving access to healthy eating within underserved communities but without complementary efforts to help these outlets sus­ tain equitable access to healthy, affordable foods these initiatives will have little long-term impact. equally as important, federal nutrition education and promotion programs administered at usda and hhs must work with relevant state and local stakeholders to ensure delivery of effective and consistent healthy eating messages and technical assistance. with adequate and sustainable support, usda and hhs can help healthy food outlets sell healthy foods and consumers prepare and eat affordable, healthier items now available in their communities. c. food safety federal food safety laws regulate our nation's food supply through a number of federal agencies:. usda, hhs through both the food and drug administration ("fda") and the cdc, and the u.s. environmental protec ... tion agency ("epa").160 originally passed in 1906, the food safety laws are outdated, 161 and recent initiatives aim to modernize our food safety sys­ tem.162 from peanut butter to spinach to pistachios, recent food safety 160. see pure food and drug act of 1906,34 stat. 768,768-772 (1096) (preventing the manufacture, sale, transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purpos­ es); and meat inspection acts, pub. l. no. 90-201, 81 stat 584 (1906) (codified as amended at 21 u.s.c. §643 {2010), amended by pub. l. no. 59-242, 34 stat. 1260 (1967) (mandating post-mortem inspection of every carcass, establishing sanitary standards for slaughter and processing plants, and requiring continuous usda inspection of slaughter and processing operations). 161. see caroline smith dewaal, rising imports, bioterrorism, and the food supply, 59 food & druo l.j. 443, 433-39 (2004); and sheila fleischhacker, comment, food for thought or terror: the legal issues surrounding agroterrorism, 16 san joaquin aori. l. rev. 79,92-97 (2006-2007). 162. food safety modernization act of2009, h.r. 875, i 11th cong. {2009) (assigning all the authorities and responsibilities of the secretary of hhs rela~ to food safety to the administrator of food safety, who is to: (1) administer a national food safety program; and (2) "ensure that persons who produce, process, or distribute food ... to prevent or minimize food safety hazards." other duties include: (1) requiring food establishments to adopt pre­ ventive process controls; (2) enforcing performance standards for food safety; (3) establish­ ing an inspection program; (4) strengthening and expanding foodbome illness surveillance systems; (5) requiring imported food to meet the same standards as u.s. food; and (6) estab­ lishing a national traceability system for food. in addition, the administrator is required to: (1) identify priorities for food safety research and data collection; (2) maintain a dna matching system and epidemiological system for foodbome illness identification, outbreaks, 48 indiana health law review [vol. 7:23 scares have forced farmers, food corporations, and small-scale vendors to reevaluate their liability. 163 small-sized farmers and comer store owners might be most at risk for absorbing the cost of liability insurance or for pur­ chasing insurance that ends up not covering all their needs.164 for instance, a farmer may have insurance that does not cover her transactions at a far­ mer's market.165 a small vendor might not have adequate coverage for sell­ ing unpasteurized milk, even though his state allows selling raw goat milk.166 president obama created a food safety working group in march 2009 and, in july 2009, this group submitted to the president three core food safety principles that should guide the development of a modem, coordinated food safety system: .. (1) preventing harm to consumers is our first priority; (2) effective food safety inspections and enforcement depend on good data and analysis; [and] (3) outbreaks offoodbome illness should be identified quickly and stopped."167 subsequently, the president an­ nounced usda and hhs individual and joint actions on salmonella, e. coli, national traceback and response system, along with the addition of new positions and the continuation of the food safety working group.168 these initial steps move the modernization of food safety forward, but continued reform is needed. further work should consider the financial impacts current and new regulations may ultimately have on smaller-scale farms and small business vendors, ranging from documentation require­ ments for traceability to associated liability insurance tax credits. and containment; (3) establish guidelines for a sampling system; (4) establish a national public education program on food safety; (5) conduct research on food safety; and (6) estab­ lish a working group on foodborne illness surveiuance. the act also requires the develop­ ment of the food-borne illness health registry and the reporting on the resources being dedicated to foodborne illness and food safety research. other provisions are included, such as whistleblower protections and civil actions). 163. marne coit, staff attorney, nat'l. agricultural law center, university of arkan­ sas school of law, presentation at farmers' markets as a community collaboration confe­ rence: food safety & vendor liability (feb. 6, 2009), available at http:!/ www.nationalaglawcenter.org (last visited june 9, 2009). 164. press release, kathy dahlk.emper, chairwoman, subcomm. on regulations and healthcare of h. comm. on small businesses, food recalls hit small businesses hard (mar. 11, 2009) (on file with indiana health law review), available at http:/ /www.house.gov/smbizjpressreleases/2009/pr-3-11-09-food-recalls.html (last visited june 11, 2009). 165. coit, presentation, supra note 163. 166. !d. 167. letter from food safety working group to president barack obama (july 2009), available at http://www.foodsafetyworkinggroup.gov/home.htm (last visited october 15, 2009). 168. press release, the white house, office of the vice president, obama administration delivers on commitment to upgrade u.s. food safety system (july 7, 2009) (on file with indiana health law review), available at http://www.whitehouse.gov/the_press _office/obama­ administration-delivers-on-commitment-to-upgrade-us-food-safety-system/ (last visited june 10,2010). 2010] carrots or candy in corner stores? 49 d. child nutrition reauthorization similar modernizing efforts aim to update school nutrition standards for foods and beverages sold outside the school meals to improve the school food environment.169 congress should consider technological incentives for the development and promotion of healthier items in healthier sizes, which might ultimately end up in both schools and comer stores.110 efforts should also be made to evaluate if and how the federal government can help schools consolidate their purchasing and contract power to leverage their collective purchasing power to more effectively purchase a variety of healthy items at affordable prices and incentivize the development of more healthy items and promotional materials.171 support should be granted to team nutrition networks to coordinate approaches at the school and state level, including local efforts to work. with comer stores and food corpora­ tions to ensure equal distribution of healthy foods.172 congress should also consider ways to incentivize local school well­ ness policies and associated policy councils to work. within and outside the school doors to provide and promote healthy foods. 173 the local wellness policy 2004 mandate may have indirectly enabled schools an opportunity to address food marketing on school campus.174 the national alliance for nutrition and activity (''nana'') advocates for congress, through the child nutrition reauthorization 2009, to require schools to explicitly ad­ dress food marketing in schools.175 outside of the school cafeteria, congress should continue to evaluate the recent changes to the usda women, infant, and children (wic) food package and consider further methods of increasing participant access and participation in farmers' markets. efforts should be made to consider ways the federal government can leverage its purchasing power through wic, along with snap, to increase the availability of fruits and vegetables in urban comer stores and small rural and tribal grocery stores.176 further 169. healthy, hunger-free kids act of 2010, s. 3307, lllth cong. (2009-2010); and improving nutrition for america's children act, h.r. 5504 111th cong. (2009-2010). 170. corinna hawkes, freelance consultant, presentation at the robert wood johnson foundation health eating research food systems & public health conference: leveraging the food supply chain to promote healthy diets and prevent obesity (apr. 2, 2009). 171. id. 172. society for nutrition education, recommendations for improving children's nutrition education and promotion: 2009 child nutrition reauthorization {2009) http://www.sne.org/documents/cnrusdasept52008 _approved92008.pdf (last visited june 6, 2009). 173. child nutrition and wic reauthorization act of2004, pub. l. no. 108-265, §204, 118 stat. 780 (2004). 174. ld. 175. national alliance for nutrition & activity, child nutrition reauthorization rec­ ommendations, http://cspinet.org/new/pdf7cnr _recommendations_ 2009.pdf (last visited june 8, 2009). 176. healthyeatingactivellvingconvergbncepartnership,supranote 137. 50 indiana health law review [vol. 7:23 work is needed to increase the breadth and depth of wic and snap pur­ chases through farmer's markets. this work will require outreach to ven­ dors and farmers, along with educating and promoting these outlets to wic and snap participants. e. food marketing in 2006, the institute of medicine ("10m") reported food and beve­ rage marketing influences children's dietary intakes and weight status and recommended both public and private sectors work on improving the pro­ motion of healthy foods and beverages.177 in the 1970s, the federal trade commission ("ftc") was unsuccessful in its attempt to regulate food mar­ keting to children, because of constitutional limits on restricting commer­ cial speech and political pressures. 178 nonetheless, president obama could respond to the rising childhood obesity rates and work with congress to curtail food marketing in certain public venues like schools, or regulate product placements in grocery or comer stores at children's eye-level.179 developing government-industry strategies might be an effective approach to incentivize corporations to market healthy items and self-regulate them­ selves and their peers. likewise, government small-business community organization partnerships could potentially facilitate the development of in­ store promotion of healthier items within comer stores. in march 2009, president obama requested research into whether or not the government should set standards for determining which foods are healthy and appropriate to market to children and adolescents as old as se­ venteen.180 the bill created a new interagency working group on food marketed to children, requiring representatives from the ftc, fda, cdc, and usda.181 this group is charged with developing the report, deciding on which media outlets to address, and setting forth recommendations. 182 the ftc has requested public comments and will be hosting a public form, 177. institute of medicine, food marketing to children and youth: threat or opportunity? 226-309, 373-388 (2006). 178. see jennifer l. harris, et al., a crisis in the marketplace: how marketing contri­ butes to childhood obesity and what can be done, 30 ann. rev. pub. healtii. 211, 219 (2009); and david s. modzeleski, note, lorillard tobacco v. reilly: are we protecting the integrity of the first amendment and the commercial free speech doctrine at the risk of harming our youth?, 51 cam. u. l. rev. 987,987 (2002). 179. see lee j. munger, comment: is ronald mcdonald the next joe camel? regu­ lating fast food advertisements that target children in light of the american overweight and obesity epidemic, 3 conn. pus. int. l.j. 456, 474 (2004) (discussing how the court ruling in lorillard tobacco co. v. reilly, 533 u.s. 525 (2001), seemingly allows states or even schools the authority to regulate food marketing on school campuses). 180. omnibus appropriations act of2009, pub. l. no. 111-8, 123 stat. 524 (2009). 181. ld 182. id. 2010] carrots or candy in corner stores? 51 entitled "sizing up food marketing and childhood obesity. " 183 while the working group is scheduled to discuss some of their findings at the upcom­ ing forum,184,the final report is expected by july 2010.185 f. nutrition labeling the nutrition labeling education act (nlea) grants the fda the au­ thority to require nutrition labeling of most of the foods regulated by the agency. 186 fda also regulates all nutrition content claims (e.g., "low fat") and health claims (e.g., "prevents health disease").187 the fda has consi­ dered using its authority to improve front-of-package information to con­ sumers about serving sizes and calories. 188 recently, fda and cdc requested guidance from the iom on front-of-package nutrition rating sys­ tems and symbols. 189 due in 2010, information gleaned from this report may guide regulatory approaches and industry responses to use front-of­ package nutrition rating systems and symbols to inform consumers in an accurate, consistent format about the nutritional quality of food and beve­ rages items and the relationships between the item and health outcomes. in the meantime, certain food and beverage companies participate in the children's advertising review unit, an industry financed voluntary self­ regulation program.190 restaurants did not have to comply with nlea.191 new york city over came legal challenges to defend their menu labeling law, which set the stage for other local, state, and, ultimately, the federal government to fol183. posting of federal trade commission, ftc to host forum on food marketing to children, http://www.ftc.gov/opa/2009/09/foodmarket.shtm (sept. 29, 2009) (announcing a december 15, 2009 public forum hoping to bring together industry representatives, federal regulators, consumer groups, scientists, and legal scholars). 184. id. 185. omnibus appropriations act of2009, pub. l. no. 111-8, 123 stat. 524 (2009). 186. nutrition labeling and education act of 1990, pub. l. no. 101-535, 104 stat. 2353 (1990) (codified at 21 u.s.c. §343). 187. id. at §3, 104 stat. at 2357-60. 188. lauren m. tarantino, ph.d., acting director, office ofnutritional products, labe­ ling, and dietary supplements, center for food safety and applied nutrition, food and drug administration, letter to food manufacturers about accurate serving size declara­ tion on food products, mar. 12, 2004, available at http://www.fda.gov/f ood/labelingnutritionjfoodlabelingguidanceregulatorylnformation/1 nspectioncompliance!warningotherletters/ucml10234.htm (last visited jun. 11, 2010). 189. institute of medicine, announcement: tom considers front-of-package food labeling, dec. 2009, available at http://www.iom.edu/globai/news%20announcements/iom-considers-front-of-package­ food-labeling.aspx (last visited jun. 11, 2010). 190. council of the better business bureau, about the children's advertising review unit, available at http://www.caru.org/aboutlindex.aspx (last visited jun. 11, 201 0). 191. id. at§2(a), i04stat.at2353. 52 indiana heal til law review [vol. 7:23 low.192 indeed, a mandatory menu labeling requirement was enacted during health care refonn.193 this federal law preempts194 local and state menu labeling ordinances. 195 even though the menu labeling law is based on a strong public health rationale and founded on consumer rights, 196 further work is needed to understand the impact these policy changes have had (e.g., in new york) and will have (e.g., nationwide) on consumer behavior, dietary intakes, and health outcomes.197 initial research on new york city's menu labeling ordinance found some positive effects on low-income ~onsumer awareness, but not any significant impacts on caloric consump­ tion.198 researchers and policymakers need to consider a more holistic pol­ icy approach to the food environment and figure out the appropriate balance of initiatives targeting certain aspects of the food environment, such as fast food restaurants. lllustrative of this, an initial assessment of the los an­ geles ban on new construction of fast food restaurants in south los angeles did not find much of a positive impact on improving access to healthy eat­ ing.199 the ban evaluated did not address the area's exposure to conveni192. new york department of health and mental hygiene board of health, notice of adoption of an amendment (§81.50) to article 81 of the new york city health code, withstanding judicial challenge in defendant's memoradum of law in op­ position to plaintiff's motion for injunction pending appeal, new york state restaurant association v. new york city board of health, (s.d.n.y. 2008) (no. 08 civ. 1000), denied; and was informed by earlier successfol challenge in new york restaurant association v. new york city board of health, 509 f. suppl. 2d 351 (s.d.n.y. 2007). 193. the patient protection and affordable care act. pub. l. no. 111-148, sec. 4205 nutrition labeling of standard menu items at chain restaurants (2010) (requiring chain restaurants with 20 or more outlets to provide calorie labeling on chain restaurant menus, menu boards, and drive-through displays, as well as on vending machines). 194. u.s. const. art. vi, cl. 2 (also known as the supremacy clause, and resolving conflicts between the federal government and a state government in favor of the federal government, within its constitutional parameters); see also mcculloch v. maryland, 17 u.s. 316, 436 (1819) (explaining how state laws cannot interfere with the federal government, and federal law preempts over inconsistent state action). 195. u.s. const. art. vi, cl. 2 (also known as the supremacy clause, and resolving conflicts between the federal government and a state government in favor of the federal government, within its constitutional parameters); see also mcculloch v. maryland, 17 u.s. 316, 436 (1819) (explaining how state laws cannot interfere with the federal government, and federal law preempts over inconsistent state action). 196. jennifer l. pomeranz & kelly d. brownell, legal and public health considera­ tions affecting the success, reach, and impact of menu-labeling law, 98 am. j. pub. healti:i1578, 1578 (2008). 197. karen glanz & deanna hoelscher, increasing fruit and vegetable intake by changing environments, policy, and pricing: restaurant-based research, strategies, and recommendations, 39 preventive med. s88, s88, s88-89 & s91-92 (2004). 198. brian elbel, et al., calorie labeling and food choices_: a first look at the effects on low-income people in new york city, 28 healtii aff. wlllo, wlllo, wlll4 & wills (2009). 199. roland sturm & deborah a. cohen, zoning for health? the year-old ban on new fast-food restaurants in south la, 28 heal til aff. w1088, wl088-97 (2009). 2010] carrots or candy in corner stores? 53 ence stores200, which evidence suggests account for a significant amount of children's food purchases and daily caloric intake.201 g. other federal options a number of other federal laws directly or indirectly affect the food environment. 202 one receiving some attention from the public health ·taw community is the takings clause of the fifth amendment (incorporated into the fourteenth amendment), permitting the federal, state, or local governments to take private property for public use if the government pays the owner just compensation.203 the court's interpretation of ''public use" is broad.204 moreover, the court determination of a taking requiring just compensation can be less than yz inch in diameter of an apartment build­ ing. 205 physical invasion is not needed, since a regulation-even if tempo­ rary, diminishing the value of a property could be deemed a taking requiring just compensation. 206 recent courts have been reluctant to find regulatory takings, though.207 to protect the public's health, the govern­ ment generally has the authority to take, destroy, or restrict the use of pri­ vate property.208 even when protecting the public's health, philip morris, inc. v. harshbarger illustrates there are limits to the states' authority.209 in philip morris, a massachusetts law requiring cigarette manufacturers to report product ingredients was preliminarily enjoined since the regulation 200. los angeles criy council, office of 1he criy ci..erk. council fn.e no. 071658(2008),amilable at bup:l/cityclerk.lacity.otwjacityclerkoonnectfmdex.cftn?fil=ccfi.viewrecord& cfull!llber}7-1658&cfid=14393210&cfi'oken=57e690e22bc5bld-687ed883-c32a-17133ae34ecb63b5f02f&jsessionid=id3076666133:tti88436448sb2dsb4cl7336f (last visited jun. 10, 2010). 201. kelley e. borradaile, et al., snacldng in children: the role of urban comer stores, 124 pediatrics 1294, 1292-1297 (2009). 202. gostin, et al., supra note 34, at 30. 203. u.s. const. amend. v; see also chicago, burlington, & quincy rr. co. v. chi­ cago, 166 u.s. 226 (1897) (incorporating the protection of economic rights into the four­ teenth amendment). 204. hawaii housing authority v. midkiff: 467 u.s. 229, 240-41 (1984). 205. loretto v. teleprompter manhattan catv corp., 458 u.s. 419 (1982). 206. first english evangelical lutheran church v. county of los angeles, 482 u.s. 304(1987). 207. see, e.g. keystone bituminous coal ass'n v. debenedictis, 480 u.s. 470, 506 (1987) (denying a takings challenge even though significant amounts of coal were required to be left un-mined as surface support for structures on top of the coal mines, because the regulation did not make mining "commercially impracticable"); and tahoe-sierra preserva­ tions council, inc. v. tahoe regional planning agency, 535 u.s. 302 (2002) (finding a gov­ ernment order prohibiting development during the creation of a comprehensive land-use plan did not constitute a "per se taking of property requiring compensation"). 208. richard goodman, et al., law in public health practice 202204 (oxford university press 2003). 209. id at 204; see also philip morris. inc. v. harshbarger, 159 f.3d 670 (1st cir. 1998). 54 indiana health law review [vol. 7:23 would unconstitutionally obtain trade secrets.210 if the government attempted· to require corner stores to allocate a number of shelves or certain child-eye-level shelves to fresh fruits and veg­ etables, corner stores could potentially challenge the government's action as a taking requiring just compensation. nonetheless, if the regulatory taking was minimal, and the stores could remain profitable, the court would likely not find the government took the shelf space nor require the government to pay just compensation for the space. even though this power may exist, invading private property might not be the most effective course to encour­ age buy-in from local comer stores. a more worthwhile federal investment could be technical assistance to states and local governments on model land use and zoning ordinances to establish and adequately support farmer's markets and community gardens, offering both residents and comer store owners consistent access to affordable, healthy foods.211 another potential federal option is the safe accountable flexible ef­ ficient transportation equity act (safetea), which could potentially provide funding for the development and maintenance of safe routes for customers to walk and bike to local food outlets.212 reassessing the u.s. and global antitrust regulations continues to be a possible, yet challenging avenue to reduce the concentration of agriculture and increase local access to food production.213 the american recovery and reinvestment act of 210. philip morris, 159 f.3d at 675-78. 211. ·leadership for healthy communities, action strategies toolkit: a guide for local and state leaders working to create healthy communities and prevent childhood obesity, may 2009, available at http://www.leadershipfornealthycommunities.orglirnages/stories/toolkit/ ac­ tion_strategies_toolkit_final%5bl%5d.pdf (last visited jun. 11, 2010); and national policy and legal analysis network to prevent childhood obesity, establishing land use protections for far­ mer :s makets,dec.2009,amilab/eathttp://www .nplanonlie.org/!>ystem/files/nplanlestablishing%20 land"/o20use%20protectionso/o20fot%20farmers%27o/o20markets _final_ 091203.pdf (last vi­ sitedjun.l0,2010). 212. safe, accountable, flexible, and efficient transportation equity act of 2005., pub. l. no. 109-59, 119 stat. 1248 (2005). 213. the clayton antitrust act of 1914, ch. 323, 38 stat. 730 (codified at 15 u.s.c. § 12 through 15 u.s.c. § 27 and 29 u.s.c. § 52 and 29 u.s.c. §52 and 29 u.s.c. §53) (ex­ empting agricultural organizations, but otherwise regulating mergers and acquisitions, amongst other arrangements, that may have an anti-competitive effect); see also harrison m. pittman, an national law center research article: market concentration, horizontal con­ solidation, and vertical integration in the hog and cattle industries: taking stock of the road ahead, nat'l. agric. l. ctr. (2005), available at http://www.nationalaglawcenter.org (last visited june 10, 2009) (discussing the following cases to explain the judicial branches' role in addressing market concentration: pickett v. tyson fresh meats, inc., 315 f.supp.2d 1172 (m.d. ala. 2004); london v. fieldale farms, corp., 410 f.3d 1295 (11th cir. 2005); south dakota farm bureau, inc. v. hazeltine, 340 f.3d 583 (8th cir. 2003), cert. denied, 124 s.ct. 2095 (2004); and smithfield foods, inc. v. miller, 367 f.3d 1061 (8th cir. 2004)); and jon lauck, an national agricultural law center research article, concentration concerns in the american livestock sector: another look at the packers and stockyards act, nat'l. agric. l. cfr. (2004), available at http://www.nationalaglawcenter.org (last visited june 10, 2009) (analyzing the past, current, and potential roles of the packers and stockyard act on 2010] carrots or candy in corner stores? 55 2009 awarded more than $119 million to states and u.s. territories, which can be used to support environmental and policy approaches to improving access to healthier foods in underserved communities.214 president obama is also working with the white house offices of management and budget and health reform and u.s. general services administration to deliver healthier foods to federal employees.215 by building a template for heal­ thier food service contracts, obama's administration hopes to provide a model of how other worksites, schools, and childcare settings can improve the nutritional quality of their food and beverage offerings. these contracts may also stimulate healthier product development and promotion strategies from the food service sector, as well as the food and beverage industry. collectively, these diverse federal options provide food for thought on the breadth and depth of authority and approaches the federal government can utilize to improve access to healthy foods in america. n. conclusion a cornucopia of federal policies can facilitate improvements in the u.s. food systems and address healthy food access disparities at the local and shelf levels. barriers-ranging from political, legal, social, and finan­ cial-may impede the enactment or the full potential of these bills. this article explained a variety of facilitators and barriers to stocking healthier food and beverage options, with particular emphasis on urban comer stores or small rural stores. this article is not exhaustive, but should guide the development of a future grocery list of the most effective and feasible ac­ tions the federal government can take to address food, health, and envi­ ronmental issues and inequalities within the local food environment. as president obama works on addressing access to health care, efforts should be made to communicate with his administration regarding their current and potential authorities to advance healthy u.s. food systems. hopefully, this administration will facilitate and support cross-agency in­ itiatives, pulling together agriculture, health, planning, commerce, energy, education, and environmental protection, amongst other sectors to more effectively and creatively collaborate to link agriculture, health, sustaina­ bility, and economic development.216 de-concentrating american livestock). 214. centers for disease control and prevention, communities putting prevention to work, available at http:/lwww.cdc.gov/cbronicdisease/recovery/community.htm (last visited jun. 13, 2010). 215. press release, u.s. general services administration, gsa to provide healthier food choices to federal employees (feb. 10, 2010), available at http://www.gsa.gov/portal/gsa/eplcontentview.do?contenttype=gsa _ basic&contentld=2 9091 (last visited jun. 13, 2010). 216. mary story, et al., food systems and public health: linkages to achieve heal­ thier diets and healthier communities, 4 j. hunger & envrl. nutrition 219, 223 (2009). 56 indiana health law review [vol. 7:23 increasing access to healthy foods requires a range of federal, tribal, state, and local legal and policies strategies. this article only focuses on federal possibilities. throughout the development, implementation, and evaluation of potential federal food environment initiatives, the federal government should involve multiple stakeholders, ranging from farmers to food and beverage corporations to public health professionals to regional planners to policymakers to store owners to citizens. federal strategies should complement local, state, and tribal efforts to enhance the capacity of each government level to facilitate and not impede the sale of carrots and other healthy items on the shelves of urban comer stores and smaller rural and tribal grocery stores throughout this country. indiana health law review 2012-2013 editor-in-chief pervin rusi taleyarkhan executive managing editor brock landon easton executive editor jennifer nicole risser executive production editors daniel isaac hageman kyle ryan wood executive notes editor julia suzanne hudson executive articles editor alyssa conley james executive symposium editor james m. inman executive business editor kimberly anne opsahl note development editors cora ann davidson frandy st. louis lindsey stout articles editors john brett curry justin david rumer william c. starr associate editor myriam serrano members christopher michael anderson james blair banister samuel dayton jessica m. dugdale romy naser elswerky charlotte fillenwarth paul k. ho thomas frederick martin charity ann mansfield james timothy nussbaum jacob m. o'brien janice kristina pascuzzi laura bolon sahm nicole marie long sharp megan michelle smith faculty advisors nicholas p. terry (chair) david orentlicher (chair) 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professor oflaw and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. cynthia a. baker, clinical professor of law and director, program on law and state government. b.a., j.d., valparaiso university. gerald l. bepko, indiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. shawn boyne, associate professor oflaw, dean's fellow; grimes fellow. b.a., cornell university; m.b.a., university of minnesota; j.d., university of southern california's gould school of law, m.a., ph.d., university of wisconsin; ll.m., justus-liebig-universitit. robert brookins, professor oflaw. b.s., university of south florida; j.d., ph.d., cornell university. jeffrey 0. cooper, associate professor oflaw. a.b., harvard university; j.d., university of pennsylvania law school. eric r. dannenmaier, professor oflaw, dean 's fellow; grimes fellow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university. james d. dimitri, clinical professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer a. drobac, professor of law. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. yvonne m. dutton, associate professor oflaw. b.a., columbia university; m.a., university of colorado at boulder; ph.d., university of colorado at boulder; j.d., columbia law school. george e. edwards, carl m gray professor oflaw; faculty advisor to the ll.m track in international human rights law; director, program in international human rights law; john s. grimes fellow. b.a., north carolina state university; j.d., harvard law school. frank emmert, john s. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university of munich law school; ll.m., the university of michigan law school; ph.d., university of maastricht; diploma, european university institute. nicholas georgakopoulos, harold r. woodard professor oflaw. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. carrie hagan, clinical associate professor of law. b.a., university of kansas; j.d., university of cincinnati college of law. john lawrence hill, professor oflaw. b.a., northern illinois university; j.d., ph.d., georgetown university. max huffman, associate professor oflaw; dean's fellow. b.a., cornell university; j.d., university of cincinnati college of law. lawrence a. jegen, iii, thomas f sheehan professor of tax law and policy. b.a., beloit college; j.d., m.b.a., university of michigan; ll.m., new york university school of law. robert a. katz, professor oflaw. a.b., harvard college; j.d., university of chicago law school. linda kelly hill, m dale palmer professor oflaw. b.a., j.d., university of virginia. max huffman, associate professor of law and dean's fellow. b.a., cornell university; j.d., university of cincinnati college of law. andrew r. klein, paul e. beam professor oflaw; chiefofstaff office ofthe chancellor oflupui. b.a., university of wisconsin; j.d., emory university school of law. norman lefstein, professor oflaw and dean emeritus. ll.b., university of illinois college of law; ll.m., georgetown university law school. allison martin, clinical professor of law. b.s., j.d., university of illinois. deborah mcgregor, clinical professor oflaw and assistant director oflegal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law center. emily morris, associate professor oflaw and dean 's fellow. a.b., harvard university; j.d., university of michigan law school. novella nedeff, clinical associate professor oflaw. b.a., j.d., indiana university. david orentlicher, samuel r. rosen professor oflaw and co-director ofthe william s. and christine s. hall center for law and health. b.a., brandeis university; j.d., m.d., harvard university. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. michael j. pitrs, professor oflaw; dean's fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. fran quigley, clinical professor oflaw, health and human rights clinic, indiana university robert h. mckinney school of law; senior advisor, indiana university center for global health. b.a., hanover college; m.a., indiana university; j.d., indiana university robert h. mckinney school of law. florence wagman roisman, william f. harvey professor oflaw. b.a., university of connecticut; ll.b., harvard law school. joan m. ruhtenberg, clinical professor oflaw and director oflegal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university robert h. mckinney school of law. margaretryznar, associate professor oflaw. b.a., university of chicago; m.a., jagiellonian university; j.d., university of notre dame law school. joel m. schumm, clinical professor of law. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university robert h. mckinney school of law. lea shaver, associate professor of law. b.a., m.a., university of chicago; j.d., yale law school. lahny r. silva, associate professor oflaw. b.a., m.a., boston university; j.d., university of connecticut school of law; ll.m., university of wisconsin law school. frank sullivan, jr., professor ofpractice. a.b., dartmouth college; j.d., indiana university maurer school of law; ll.m., university of virginia school of law. margaret c. tarkington, associate professor oflaw. b.a., brigham young university; j.d., j. reuben clark law school, brigham young university. nicolas p. terry, hall render professor of law; co-director of the william s. and christine s. hall center for law and health. b.a., kingston university; ll.m., corpus christi college, university of cambridge. carlton mark waterhouse, associate professor oflaw; dean's fellow. b.s., pennsylvania state university; j.d. with honors, howard university school of law; m.t.s., emory university, chandler school of theology; ph.d. with honors, emory university. frances watson, clinical professor oflaw. b.s., ball state university; j.d., indiana university robert h. mckinney school of law. lloyd t. wilson, jr., professor of law; director, joint center for asian law studies; director, chinese law summer program; director, american law for foreign lawyers ll.m program. b.a., wabash college; m.a., duke university; j.d., indiana university maurer school of law. diana r.h. winters, associate professor oflaw. b.a., brown university; m.a., harvard university; ph.d., harvard university; j.d., new york university school of law. r. george wright, lawrence a. jegen iii professor oflaw. a.b., university of virginia; ph.d., indiana university; j.d., indiana university robert h. mckinney school of law. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university of nebraska; ll.m., new york university school of law. edward p. archer, professor oflaw emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, iii, professor oflaw emeritus. a.b., j.d., m.a.l.s., the university of michigan. paul n. cox, professor of law emeritus. b.s., utah state university; j.d., university of utah college of law; ll.m., university of virginia school of law. clyde harrison crockett, professor oflaw emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. falender, professor oflaw emerita. a.b., mount holyoke college; j.d., indiana university robert h. mckinney school of law. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor oflaw emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harold greenberg, professor oflaw emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor oflaw emeritus. a.b., juniata college; j.d., george washington university law school. william f. harvey, carl m. gray professor oflaw & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. william hodes, professor oflaw emeritus, a.b., harvard college; j.d., rutgers university school of lawnewark. william andrew kerr, professor oflaw emeritus. a.b., j.d., west virginia university; b.d., duke university; ll.m., harvard law school. eleanor dearman kinney, hall render professor oflaw, co-director ofthe william s. and christine s. hall center for law and health emerita. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. william e. marsh, professor oflaw emeritus. b.s., j.d., university of nebraska. susanah m. mead, professor oflaw emerita. b.a., smith college; j.d., indiana university robert h. mckinney school of law. h. kathleen patchel, associate professor oflaw emerita. a.b., huntington college; j.d., university of north carolina law school; ll.m., yale law school. ronald w. polston, professor oflaw emeritus. b.s., eastern illinois university; ll.b., university of illinois college of law. kenneth m. stroud, professor oflaw emeritus. a.b., j.d., indiana university-bloomington. james w. torke, carl m gray professor oflaw emeritus. b.s., j.d., university of wisconsin. james patrick white, professor oflaw emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. lawrence p. wilkins, william r. neale professor oflaw emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., university of texas school of law. mary therese wolf, clinical professor oflaw emerita. b.a., saint xavier college; j.d., university of iowa college of law. ruth lilly law library faculty judith ford anspach, professor oflaw and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. susan david demaine, research and instruction librarian. b.a., pennsylvania state university; m.s.l.s., university of kentucky; j.d., university of kentucky. debra denslaw, research and instruction librarian. b.a., franklin college; m.s., university of illinois, urbanachampaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, cataloging and government documents librarian. a.b., taylor university; m.l.s., indiana university. benjamin j. keele, research and instruction librarian. b.a., university of nebraska-lincoln; j.d., indiana university maurer school of law; m.l.s., indiana university school of library & information science. catherine lemmer, head ofinformation services. b.a., lawrence university; j.d., university of wisconsin; m.s., university of illinois. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. miriam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. indiana health law review volume 10 2013 issue 1 table of contents mcdonald-merrill-ketcham memorial lectureship and award for excellence in law and medicine wendy k. mariner did legal education fail health reform? and how health law can help .............................................. 1 articles katherine drabiak-syed granular control of ehrs to overcome fragmented disclosure law: how policy choices for granularity will affect clinical care, impact secondary use of health information, and alter risks for patients and providers .................................... ..... 39 kenneth shuster because of history, philosophy, the constitution, fairness & need: why americans have a right to national health care ... ............ 75 amanda swanson 510(k) clearance: opportunities to incentivize medical device safety through comparative effectiveness research ................. 117 notes alyssa james gestational surrogacy agreements: why indiana should honor them and what physicians should know until they do............................ 175 kimberly a. opsahl using integrated care to meet the challenge of the ada's integration mandate: is managed long-term care the key to addressing access to services? ........................ 211 lindsey stout negligent credentialing as a cause of action in indiana medical malpractice litigation .................................. 249 01_10indhealthlrev[i](2012-2013) 03_10indhealthlrev[xv](2012-2013) letting lilliputians sit at the table: providing physicians with a magnified voice to counter the brobdingnagian hmo brandt r. voight* table of contents i. introduction ............................................................................... 437 ii. setting the stage for a brobdingnag-like hmo society .......................................................................................... 438 a. the sherman act and national labor relations act identify an "employee's" right to bargain collectively with the corporate employer .................................................................................. 438 b. physicians do not qualify as employees under the national labor relations act ............................................................................ 439 iii. introducing the brobdingnag-hmo to the lilliputianphysician ...................................................................................... 441 a. creating an imbalance in power between the brobdingnag-hmos and lilliputian-physicians ....................................................... 442 b. is hmo consolidation operationally effective or monopolistically substandard? ........................................................................... 444 c. double standards in evaluating hmo and physician antitrust violations .................... _ ............................................................. 446 d. the plight of the powerless physician amidst the hmo 's monopolistic authority ............................................................. 446 n. unifying lilliputian-like physicians and restraining brobdingnag-like hmos ........................................................... 448 a. an overview of legislative solutions attempted by states ....... 448 b. congress' attempted solution: the quality health care coalition act ............................................................................ 448 1. history of the quality act .................................................. 448 2. aims of the quality act ...................................................... 449 c. state antitrust exemptions for lilliputian-like physicians ....... 450 1. specific state legislative enactments ................................ 450 2. preemption problems in granting physicians antitrust exemption status ............................................................... 451 • j.d., 2007, indiana university school of law, indianapolis, indiana; b.s., 2004, but­ ler university, indianapolis, indiana. i would like to thank sarah fuhnnan for her creativity and suggestion in using the light-hearted familiar english reference of gulliver's travels as a unify­ ing theme for such a long-winded and complicated subject. the reoccurring theme provides an illustration for the theory and brings to life the many words used to explain this lengthy discus­ sion. 436 indiana health law review [vol. 4:435 3. avoiding preemption problems and ensuring antitrust exemption status for physicians by satisfying the state action doctrine ............................................................................. 451 d. a wp statutes as a popular alternative solution to empowering lilliputian-like physicians ........................................................ 453 1. awp statutes defined ........................................................ 453 2. the mccarran-ferguson exception .................................. 453 3. awp statutes prove to be an inadequate solution to empowering physicians ..................................................... 454 v. dwarfing the brobdingnag and magnifying the voice of the lilliputian .................................................................................... 455 a. proposed legislation to enlarge the influence of the lilliputian-like physicians and counterbalance the giant power of geographically dominant hmos ...................................................................... 455 b. a recent nlrb decision laid the foundation for granting physicians the authority to bargain collectively in specific circumstances .......................................................................... 455 c. identifying the specific circumstances that would authorize lilliputian-like physicians to bargain collectively with dominant hmos ....................................................................................... 456 d. learning from the mistakes of prior legislative attempts and effectively crafting the proposed legislation .......................... 460 1. ensuring adequate state oversight and satisfaction of the state action doctrine ......................................................... 460 2. focus on collective bargaining, not arbitration .............. 461 3. require good faith bargainingfromhmos .................... 462 e. predicted impacts from implementing the proposed legislation ................................................................................ 462 1. increased competition and justice for physicians through a balanced playing field ..................................................... 463 2. the impact on health care costs and subsequent economic consequences ................................................... 465 3. an improved quality of patient care ............................. .. .466 vi. conclusion ................................................................................... 467 2007] providing physicians with a magnified voice to counter hmo 437 i. introduction the fictional accounts of an eighteenth century english physician tell the story of an encounter with a population ofbrobdingnags who use their size and sheer dominance to dictate and control their world.1 large in both size and in­ fluence, these giant human-like creatures have complete authority over lemuel gulliver and his movements, considering him nothing more than a source of amusement and a second-thought. 2 forced to endure the unenjoyable experi­ ence ofbeing subject to the whims of the brobdingnags, gulliver is even more disturbed to learn that their physical size is only minor in comparison to their ignorance.3 the king has no knowledge of politics, their lifestyles are primi­ tive, and their dimwitted nature restricts progress. 4 their authority relies solely on their comparatively gigantic size. 5 these accounts of gulliver's travels parallel and illustrate the reality of the present state of managed health care organizations in america. the nature oftoday's health management organizations ("hmos'') place individual phy­ sicians in a gulliver-like position, vulnerable to and unprotected from the whims of brobdingnagian corporate powerhouses. not only are physicians outmatched in size but also in strength. robbed of any ability to effectively negotiate with dominant hmos, the small influence of physicians barely merits more than a second-thought by the hmos. as a result, both physicians and patients are subjected to a flawed system that is only magnified due to the un­ checked power and size of the giant hmo. part ii of this note will begin by considering the history of employees' rights to collectively bargain with employers as compared with the absence of physicians' rights to collectively bargain with hmos. part ill will examine the changing landscape of health care caused by the introduction ofhmos in the united states. part n will explore what solutions have been attempted thus far by various states, physicians, and the federal government, as well as how those attempts have fared. finally, in part v, this note will propose and consider the impact of a specific solution that properly extends physicians' legal rights whe­ rever a brobdingnagian society is found. not all hmo structures are bad. in­ deed, the financial structures they implement often lead to the containment of high costs and promote a more efficient provision ofhealth care. where a sin­ gle hmo or two dominate an entire area, however, the fmancial aims of the 1 jonatijanswift, 1'ravelsintoseveralremotenationsof1heworldbylemuel guwver pt. ll (lee jaffe ed., harrison & co. 2000) (1735), available at http://www jaffebros.­ com/lee/gulliver/contents.html. this novel tells the story of gulliver who discovers a remote island only to find a population of giant, human-like creatures called brobdingnags, who exert their size and hold him captive as their servant. 2 id. 3 id. 4 id. 5 id. 438 indiana health law review [vol. 4:435 hmo can begin to overtake concerns about the quality of health care provided and the rights of physicians to· autonomously conduct their practices as they deem necessary. such a society exists in geographic locations where hmos exhibit a monopolistic authority over the smaller, individually-weak physicians of the region. it is this dominant, brobdingnag-like nature that makes the hmos and their influence dangerous not only to the health care industry but also particularly to the smaller, more vulnerable physicians. it is in the hmo­ dominated worlds that legislation is needed to empower physicians and counter­ balance the abusive power enjoyed by the giant hmos. ii. seiting the stage fora brobdingnag-like hmo society a.· the sherman act and national labor relations act identify an "employee's" right to bargain collectively with the corporate employer historically, the united states has favored a free market system that en­ courages competition and attempts to prevent large, powerhouse monopolies from dictating an industry and constraining consumer choice. in an attempt to avoid large monopolistic giants that dominate and puppeteer their industry, as brobdingnags dictated their world, and constrain competition and consumer choice, congress passed the sherman act of 1890. section 2 of the sherman act establishes monopolies of commercial trade as a felony.6 specifically, it states: every person who shall monopolize, or attempt to mo­ nopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or com­ merce among the several states, or with foreign nations, shall be deemed guilty of a felony, and, on conviction thereof, shall be punished by fine not exceeding $100,000,000 if a corporation, or, if any other person, $1,000,000, or by imprisonment not exceeding 10 years 7 furthermore, for the sake of justice and deterrence, the court is also granted the discretion to impose both a fine and imprisonment on an offender convicted of the felony. 8 at that time it was believed by society that a certain inequality ofbargain­ ing power existed between employees and their employers.9 in addressing this 6 15 u.s.c. § 2 (2000). 7 15 u.s.c. § 2 (2000 & supp. n 2004). 8 /d 9 see john a. powers, the stifling of competition by the antitrust laws: the irony of 2007] providing physicians with a magnified voice to counter hmo 439 inequity, congress passed the clayton antitrust act of 1914 to provide labor employees with an outlet to voice their demands.10 the clayton act exempts labor unions :from antitrust and monopoly law by allowing unions to collec­ tively bargain on behalf of their members.11 the reason the clayton act can coexist with the shennan act, which prohibits employment collective bargain­ ing, is because the clayton act removes "human labor'' :from the "commodity or article of commerce" category and, therefore, removes ''human labor'' :from the realm of sherman act regulation.12 this labor exception permitting collec­ tive bargaining under the clayton act was also made a part of the national la­ bor relations act (''nlra"), which also formed the national labor relations board (''nlrb") to adjudicate federal labor disputes.13 the nlra specifically defined the "human labor" exception by stating that "[e]mployees shall have the right to self-organization, to form, join, or as­ sist labor organizations, to bargain collectively through representatives of their own choosing, and to engage in other concerted activities for the purpose of collective bargaining or other mutual aid or protection .... "14 similar to the original intentions of congress in passing the clayton act, the purpose of the nlra definition and antitrust exemption was to ."promote industrial peace and stability'' by ensuring that all parties are treated fairly. 15 fulfilling its purpose, blue collar workers began utilizing collective bargaining to voice their demands and "level the playing field" between themselves and their employers by form­ ing labor unions and collective bargaining units.16 b. physicians do not qualify as employees under the national labor relations act despite such progress in the arena of labor employees, physicians who are deemed to be "[i]ndependent, self-employed, or non-salaried" do not fall under the employee antitrust exemption established in the nlra, are discriminatorily branded as professional employees or independent contractors, and are pre­ vented :from collective bargaining.17 in defining "employee", the nlra spe­ cifically excepts certain persons, stating that the term "employee ... shall not include any individual employed as an agricultural laborer, or in the domestic the health care industry, 15 j.l. & health 223, 232 (2000) (discussing how the national la­ bor relations act was enacted to fix this problem). 10 15 u.s.c. § 17 (2000). ii /d. 12 i d.; see also ellen l. luepke. white coat, blue collar: physician unionization and managed care, 8 annalsiiealthl. 275,282 (1999). 13 luepke, supra note 12;seeals-onationallaborrelationsact,29u.s.c. §§ 151-169 (2000). 14 29 u.s.c. § 157. 15 powers, supra note 9 (citing these holdings as evidence of the nlra's purpose of promoting "industrial stability" and "encouraging collective bargaining") (citations omitted). 16 /d. (citing am. ship bldg. co. v. nlrb, 380 u.s. 300 (1965)). 17 luepke, supra note 12, at 290. 440 indiana healrn law review [vol. 4:435 service of any family or person at his home, or any individual employed by his parent or spouse, or any individual having the status of an independent contrac­ tor, or any individual employed as a supervisor .... "18 in squarely addressing such persons outside the defini­ tion of an "employee," the nlra then goes on to define an independent contractor or professional employee as: (a) any employee engaged in work (i) predominantly in­ tellectual and varied in character as opposed to routine mental, manual, mechanical, or physical work; (ii) in­ volving the consistent exercise of discretion and judg­ ment in its perfonnance; (iii) of such a character that the output produced or the result accomplished cannot be standardized in relation to a given period of time; (iv) requiring knowledge of an advanced type ... ; or (b) any employee, who (i) has completed the courses of special­ ized intellectual instruction and study •.•. 19 as a result, only the fifteen percent of physicians who are employed by the government, hospitals, or hmos and are not considered independent con­ tractors or supervisors are classified as employees and covered under the nlra. 20 the remaining eighty-five percent of physicians who practice solo or in private practice groups are considered independent contractors or "profes­ sional employees" and, consequently, do not qualify for the nlra antitrust exemption. 21 furthermore, because these physicians are not protected by the antitrust exemption, any collaboration or joint activities are considered monop­ oly practices, price-fixing, and a restraint of trade, and will subject the physi­ cians to criminal liability under the shennan act. 22 without the protection of the antitrust exemption, these physicians are placed in a lilliputian position, exposed to the forces of the industry they live within and often times are over­ whelmed by the sheer size and dominance of their opponents.23 18 29 u.s.c. § 152(3). 19 id § 152(12) . . 20 dionnekollerfine,exploitationoftheelite: a coaeforphysician unionization,45 st. louis u. l.j. 207, 214 (2001). 21 id 22 luepke, supra note 12, at 290 (citing 15 u.s. c.§ 1). 23 see swift, supra note 1, at pt i. at another point in his travels, gulliver wakes up on a beach, only to find himself tied and bound to the ground. unable to move, he notices an anny of miniature, human-like creatures fastening and securing the ropes that bind him. these crea­ tures represent the population and people oflilliput. while individually the lilliputians would prove no match for the strength of even gulliver, as a singular unified force, the lilliputians exhibit a power equal to that of any brobdingnagian. small in stature, their culture is sophisti­ cated and progressive. their influence is only diminished by their size and the difficulties it poses in addressing the larger and overwhelming forces of the world. 2007] providing physicians wit1i a magnified voice to counter hmo 441 ill. introducing the brobdingnag-hmo to the lilliputian­ physician the introduction ofhmos has dramatically altered the landscape of the health care industry, as well as the way the nation approaches health care. the customary practice prior to the development ofhmos consisted of an environ­ ment lacking direct contracts between physicians and insurance companies. this meant that consumers paid for the services physicians provided according to their market-determined value. there was no middle man, insurance compa­ nies did not play a managerial role within the physician-patient relationship, and preventive care was not prevalent.24 in this age-old time where a medical service was a more direct, face-to-face, transparent business transaction, pa­ tients were acquired by word of mouth, and no cost-saving incentives existed to prevent a physician from offering as many medical services as necessary to ad­ dress the patient's needs and ensure optimal health.25 over time, however, premium level health care began to demand premium prices. in an attempt to reduce the significantly increasing health care costs in the early 1970s, the government passed the health maintenance organization act of 1973.26 by definition, "managed care is 'a type of health care financing and delivery that seeks to contain costs through using administrative procedures and granting financial incentives ... "' to physicians. 27 it is clear that the gov­ ernment's introduction and encouragement of such a business into the health care industry reveals its primary motivation: the reduction of cost at any ex­ pense, including the improvement of quality.28 while a one-dimensional, corporate attitude may be appropriate in the commercial context when dealing with material goods, it is inappropriate and inadequate for a health care industry aimed at preserving the very existence of human life. hmos can provide an effective means of constraining costs and improving the organization of how physicians provide health care to the public. however, the tendency and inherent danger is for hmos, with their financial focus, to jeopardize the interests of patients and quality care where those inter­ ests threaten the fmancial bottom line. as a result, a multi-dimensional perspec­ tive that couples consideration of patient needs alongside a concern for financial maximization must be employed to balance the all interests involved, allowing each to counteract the other in order to prevent sacrificing either. 24 amerihealth inc., 329 n.l.r.b. 870, 871 (1999). 25 id. at 872. 26 health maintenance organization act of1973, pub. l. no. 93-222, 87 stat. 914 (co­ dified as amended in scattered sections of 42 u.s.c. ); see also fine, supra note 20, at 210. 27 e. douglas baldridge, jr., physicians versus managed care: is it time for physician unions?, 28 n. ky. l. rev. 65, 70 (2001) (quoting health choice ofn.w. mo., inc., 60 fed. reg. 51808, 51813 (1995)). 28 fine, supra note 20, at 210. 442 indiana health law review [vol 4:435 otherwise, the financial myopia that hmos sometimes suffer will continue to transform the practice of medicine into the business of health care. present day physician practices and procedures are constrained by con­ tractual obligations to hmos. where once absent, hmos now play a manage­ rial role within the physician-patient relationship and influence physicians by providing suggestions and opinions that are primarily based on financial con­ cerns and without medical expertise. as of 1999, hmos had captured thirty­ five percent of insured patients, and this trend was rapidly increasing, expand­ ing not only the scope of the hmo, but also its power as well.29 furthermore, the financial influence of an hmo has the ability to provide physicians with incentives that may be contrary to the natural practice of medicine, including "an incentive to acquire as many healthy patients as possible and see them as infrequently as possible" in order to quickly generate revenue and clientele.30 this business based incentive goes hand in hand with the business moti­ vations and focus of an hmo but can run counter to the physician's primary objective of treating patients to obtain optimal health. in addition, a physician's acquisition of patients has changed from word of mouth to a reliance on the marketing efforts and salesmanship ofhmos to gain the business oflocal em­ ployers and their employees.31 as a result, the introduction ofhmos and their increasing interference with physician autonomy has left some physicians feel­ ing like they have lost control of their practices.32 a. creating an imbalance in power between the brobdingnag-hmos and lilliputian-physicians the presence and growing popularity ofhmos has created an imbalance in situations where a very few number of hmos dominate a large number of the nation's insured population. "changes in the health care industry have led to an increased concentration of health care plans, including more than 162 mergers ... " between 1989 and 1999.33 furthermore, congressional findings revealed that the number of americans who receive their health care coverage from managed care plans increased ten fold between 1979 and 1999.34 in par­ ticular instances, one or two hmos may dominate a market to such a degree as to nearly constitute a monopoly itself. a report published by interstudy in de­ cember of 1998 "showed that two managed care companies dominate[ d] the 29 amerihealth inc., 329 n.l.r.b. at 871. 30 id at 872. 31 ld. 32 fine, supra note 20, at 211-l3; see also luepke, supra note 12, at 277 (noting a "ris­ ing degree of unrest" among physicians). 33 quality health care coalition act of 1999: hearing before the comm. on the judici­ ary, 106th cong. 10 (1999), available at http://commdocs.house.gov/committees/judiciary­ /hju62446.000/hju62446 _ of.htm [hereinafter quality health care coalition act]. 34 ld. 2007] providing physicians with a magnified voice to counter hmo 443 health insurance product market in the philadelphia region. "35 "excluding tra­ ditional medicare and medicaid patients, these two companies control[ ed] 76% of the market[;]" the equivalent of 3.8 million people out of the 4.3 million population. 36 furthermore, the leading managed care company held a majority of this market all by itself, controlling 57% of the market share.37 the american medical association's ("ama") study of competition in health insurance exposes the reality and scope of this problem. in competition in health insurance: a comprehensive study of us markets, the ama evalu­ ates the concentration of major u.s. metropolitan markets and the market share of individual insurers in those markets. 38 the 2004 study analyzed ninety-two metropolitan areas and found that 93% of the metropolitan areas were highly concentrated.39 furthermore, 95% of these metropolitan areas contain at least one insurer that has a market share of 30% or greater all by itself. 40 thirty-seven percent of these metropolitan ar­ eas have at least one insurer with a market share of 50% or greater, and 6% have at least one insurer that has a market share of70% or greater.41 where reliable metropolitan area data were unavailable, the study ana­ lyzed data at the state level. 42 the study revealed even more disturbing results of domination in areas that are inherently less equipped, less diverse, and more susceptible to corporate control and monopolistic influences. similar to the study of metropolitan areas, 93% of the states were deemed highly concen­ trated. 43 furthermore, in terms of market share by individual insurers, the study found that 88% ofthese state-level markets contained at least one insurer with a 35 !d. at 23. 36 !d. 37 !d. 38 am. med. ass'nprivate sectoradvoc. group, am.med.ass'n,2004 update­ competition in health insurance: a comprehensive study of u.s. markets (2004) (on file with author) [hereinafter 2004 competition in health insurance] ("the study bases its analy­ sis of competition on health insurer market shares and on the herfindahl hirshman index." the herfindahl hirshman index is "a mathematically derived index of market concentration" that the federal trade commission and united states department ofjustice themselves rely on "as an important calculation in evaluating the impact of mergers on competition in a market."); see generally am. med. ass'n private sector advoc. group, am. med. ass'n, 2005 update­ competition in health insurance: a comprehensive study of u.s. markets passim (2005) available at www.ama-assn.org/ama 1/pub/upload/mm/368/compstudy _52006.pdf (presenting the most updated data regarding the concentration ofhmos in the health insurance industry). 39 2004 competition in health insurance, supra note 38. 40 !d. 41 !d. 42 !d. with the exception of two states, these were situations where state populations are sparse with below six million residents, making collection of solely metropolitan area data less realistic and accurate and making the collective state data the best available proxy for market conditions. 43 !d. 444 indiana health law review [vol. 4:435 market share of 30% or greater. 44 even more alarming, over half of the state­ level markets contained a market insurer with a market share of 50% or greater. 45 in addition, 26% of these state-level markets contain an insurer with an overwhelming market share of700/o or greater.46 as a result, in over half of these state-level markets, a monopolistic aura and brobdingnagian presence exists through a single insurer. these figures not only demonstrate the strong dominance a small number ofhmos can pose over a geographic area and its physicians but also reflect the unprecedented consolidation of the health insurance market during the 1990s. "between 1995 and 2004, there were over 400 mergers involving health insur­ ers and managed care organizations.'.47 furthermore, some analysts believe that the health care industry is poised for another round of consolidation and another new wave of mergers is underway.48 b. is hmo consolidation operationally effective or monopolistically substandard? while common sense may suggest that consolidation results in greater op­ erational efficiencies through maximizing economies of scale and lowering costs,49 reality and ailing patients would argue differently. during these spurts of consolidation, health insurance premiums have risen dramatically without any expansion of benefits to patients and the insured. 50 meanwhile, many of the large national health insurers have posted high profits during times of eco­ nomic slowdown, making shareholders and highly paid senior executives the primary beneficiaries of consolidation. 51 hmos commonly defend their position by asserting that ease of entry in the marketplace by smaller hmos proves that large insurance companies do not 44 !d. 45 !d. 46 !d. 47 donald j. palmisano, health insurance markets out of whack, physician's news dig., mar. 2005, available at http://www.physiciansnews.com/commentary/305.html. 48 !d. (noting that an example of this new trend is "[t]he 2004 acquisition ofwellpoint health networks, inc., by anthem, inc.;• which created "the largest health insurer in the coun­ try'' and provides "coverage to 28 million americans."). also adding to the consolidation is unitedhealth group, another health insurance brobdingnag, that "has acquired four insurance companies in the past year, adding nearly four million covered lives, bringing its total to 22 million." id 49 mark l. glassman, can hmos wield market power? assessing antitrust liability in the impeifect market for health care financing, 46 am. u. l. rev. 91, 107 (1996); see also ron winslow & leslie scism, aetna agrees to acquire u.s. healthcare; pact for $8.9 billion in cash and stock will create leader in managed care, w au. st. j., apr. 2, 1996, at a2 (re­ porting that acquisition will result in the creation of a managed health care company serving twenty-three million people). so palmisano, supra note 47. sl id. 2007] providing physicians with a magnified voice to counter hmo 445 dominate the market in a significant way. the truth is that"[ e ]ntry into health insurance markets is difficult."52 this is reflected by the minimal new entries into health insurance markets during times of high profits, which is precisely the time when new entries would be expected to peak. 53 furthermore, large insurers like hmo-wellpoint and hmo-unitedhealth group are choosing to acquire existing hmos in markets instead of developing their own networks, which not only constitutes evidence of, but also helps to establish, the substan­ tial barriers to market entry. 54 indeed, even if market entry was easy, difficulty still exists in sustaining a presence in the market when the whims of an insur­ ance giant include exerting its brobdingnagian force and monetary power to acquire and eliminate smaller competition. more importantly, these circumstances result in a lack of competition in the health care industry. it is this lack of competition that has contributed to, if not created, one-sided conditions where hmos have unchecked and unbal­ anced power in relation to the physicians. as a result, hmos consistently force physicians into contracts exhibiting two main types of problems: ( 1) unfair re­ imbursement rates and (2) reduced physician control over medical decision­ making. 55 these "unfair reimbursement rates unjustly harm doctors in the short term"56 and "also harm patients in the long-term by reducing access to quality health care. "57 in some instances, unfair reimbursement rates have driven tal­ ented physicians out of a service area and experienced physicians into retire­ ment. 58 meanwhile, the physicians who willingly endure the unfair conditions have the additional burden of having their practices constrained by a maze of hmo procedures and requirements that influence and indirectly dictate medical decision-making. 59 while the hmos' direct intention is typically to cut costs and save money, in reality it creates poor, restrictive working conditions for physicians and erodes the quality of patient care.60 52 !d. 53 !d. (explaining that in its challenge to the aetna/prudential merger, the doj noted that "effective new entry for an hmo or hmo/pos plan in houston or dallas typically takes two to three years and costs approximately $50 million"). 54 !d. 55 quality health care coalition act, supra note 33, at 24. 56 !d. 57 !d. 58 see id. at 24-25. hmo dominance in dictating contract terms with physicians led one physician in pennsylvania's thirteenth congressional district to ask, "[w]hy should i put up with unfair treatment and dropping reimbursement rates when i can move across the delaware river to new jersey, and set up a health practice?" !d. at 25. this move would allow the physician to make thirty to fifty percent more revenue providing the same services. !d. 59 !d. at24. 60 !d. 446 indiana health law review [vol. 4:435 c. double standards in evaluating hmo and physician antitrust violations the federal trade commission ("ftc") and the department of justice ("doj") have acknowledged the dramatic changes in the health care market.61 in response, they have published joint guidelines that advise insurance compa­ nies how to avoid antitrust liability.62 enforcement of these guidelines, how­ ever, has been very relaxed. 63 indeed, doj attorney mark botti was only able to think of"one instance where the federal agencies have challenged a health insurer merger. "64 by contrast, physicians have faced higher scrutiny. indeed, in april of 2002, the ftc expressly declared an intention to "find and bring cases against physicians" for antitrust violations. 65 between apri12002 and december 2004, when the ftc brought twenty-one complaints against physicians, twenty de­ cided to settle rather than incur the wrath of the ftc and face exploitation dur­ ing a long financial legal battle. 66 such dominance not only violates a sense of fairness and equality among parties in the health care industry but also promotes a monopolistic aura. this dominance is a sign that hmos lack sufficient competition to be held in check and lends itself to abusive and unfair practices, including the aforementioned reimbursement rates that are driven so low as to threaten the ability of physi­ cians and hospitals to maintain quality patient care. d. the plight of the powerless physician amidst the hmo's monopolistic authority ironically, this lack of competition, consumer choice, and the hmo's un­ fettered control over establishing price are the very reasons physicians are pre­ vented from jointly negotiating with hmos. antitrust arguments against 61 see glassman, supra note 49, at 14 7 n.90 (referencing the united states department of justice and federal trade commission's 1996 statements of antitrust enforcement policy in health care) (observing that "health care markets have continued to evolve in response to con­ sumer demand and competition in the marlcetplace''). 62 glassman, supra note 49, at 147 n.91 ("although the doj & ftc guidelines do not directly address the activities ofhmos, statement 9 of the enforcement policy'' does indicate such an intention by establishing analytical principles relating to multiprovider networks. ''this statement establishes principles for review of arrangements that closely resemble and deal di­ rectly with hmos, to be used to determine compliance with antitrust laws.") (citation omitted). 63 id. at 147 n.92 ("[r]eporting that [the] doj and ftc gave antitrust clearance to 19 of 23 business arrangements addressed since adoption of[ the] joint enforcement policy. the ftc cleared nine of 13 deals among providers it reviewed, and the doj cleared alii 0 of the deals it reviewed.") (citation omitted). 64 palmisano, supra note 47. 6s id 66 id 2007] providing physicians with a magnified voice to counter hmo 44 7 physicians are based on the fear that groups of physicians will significantly in­ fluence prices and consumer access. these same practices currently exist with hmos. the fear of providing physicians with too much power has led to dis­ regard the true reality that hmos have a monopolistic force in the health care industry. this leads to hypocrisy because hmos are permitted to dominate markets, having a near monopoly effect, while physicians are prevented from even nego­ tiating as a cohesive group. in order for these physicians to effectively exercise their right to practice their profession in an autonomous manner, physicians must occupy a position ofbargaining power equal to that ofhmos. therefore, in markets such as pennsylvania, where one or two hmos substantially domi­ nate the insured population, 67 physicians should have the right to bargain col­ lectively with hmos to ensure equal bargaining power and to protect their right to practice their profession. the words of samuel broder, the former director of the national cancer institute, not only articulate the feelings of physicians but also pronounce the importance of allowing both patients and physicians to retain a serious degree of control over the health care process: "[i]fit was up to the [national institute of health] to cure polio through a centrally directed program instead of an in­ dependent investigator driven discovery, you'd have the best iron lung in the world, but not a polio vaccine."68 broder's words illustrate the importance of having multiple parties with varying interests address a situation. a system that only favors one side can only hope to temper a problem with half-solutions. the hmo' s primary focus on cost containment prevents it from effectively ad­ dressing quality of care and patient needs as compared with a process that al­ lows the insight and perspective of an invested and intimately involved physician. by allowing multiple parties to have a say in the situation, their di­ vergent interests ensure that a comprehensive solution will be reached, address­ ing any potential shortcomings. conversely, allowing a one-sided, detached party, such as an hmo, to deal with the problem alone will certainly result in significant short-comings where the physicians' and patients' interests have not been adequately represented. in this instance, the absence of a physician or patient voice to counter the hmo could result in a lower quality of patient care. 67 quality health care coalition act, supra note 33, at 23. 68 samuel broder, wanted: random quotes that don't suck too much, wondeiful, lovely quotes, ambrosia software web bo., available at http://www.ambrosiasw.com­ /forums/index.php?s=9931 c4a9f462f3920a277 e83c9f22f84&showtopic= 1 05714&st=o&p= 1600 044&#entry1600044. 448 indiana realm law review [vol. 4:435 n. unifying lilliputian-like physicians and restraining brobdingnag-like hmos a. an overview of legislative solutions attempted by states numerous states and even the federal government have recognized the eroding ability of physicians to exercise a proper degree of autonomy over their professional practice. as a result, a variety of solutions have been suggested and attempted over the past few years, ranging from state statutes granting phy­ sicians the right to bargain collectively with hmos to alternative legislative approaches, including any willing provider statutes ("a wp statutes"). while much is unknown about the consequences of change in the health care industry, it is certain that hmos occupy an unchecked and unchallenged seat of authority. as a result, both physicians' and patients' rights are not prop­ erly heard or accounted for. legislation has attempted to solve this problem but has thus far been unsuccessful on the physicians' front. legislative attempts to magnify the effect and voice of physicians have been weak and underutilized. many states have feigned their attempt to address the issue through the guise of a wp statutes, which fail to promote the physician's voice and secure legal rights that are moot in today's marketplace. b. congress' attempted solution: the quality health care coalition act i. history of the quality act the federal government attempted to effectively address the plight of phy­ sicians in 2000 through the quality health care coalition act of 1999 ("qual­ ity act"). 69 the quality act offered to create an exemption to the federal antitrust laws and allow independent physicians to join together in negotiating with health plans in their geographical areas. 70 the quality act was originally introduced by then house representatives tom campbell (republican of cali­ fornia) and john conyers (democrat ofmichigan) in 1999.71 the quality act was approved by the house of representatives on june 30, 2000 by a vote of 276 to 136.72 despite strong bipartisan support, representative campbell's choice to leave the house in an unsuccessful bid for a senate seat robbed the quality act of its main sponsor, and it died in the u.s. senate for lack of a sponsor.73 69 quality health care coalition act, supra note 33, at passim. 70 id 71 christopher guadagnino, fate of joint negotiation legislation, physician's news dig., mar. 200 l, available at http://www.physiciansnews.com/cover/30 l.htinl. 72 ld. 73 id. 2007] providing physicians with a magnified voice to counter hmo 449 congressional opponents of the quality act expressed concerns that "it did not offer a clear regulatory framework for oversight of negotiations," as well as fears that it would contribute to rising health care costs through possible higher physician compensation rates. 74 in particular, the common cry ofhigher health care costs stymies and muffies any debate on the issue. these cries are often used in conjunction with sympathetic, anecdotal stories of high costs thrust upon the elderly and violations of the american "right" to health care. while these are serious concerns, over-emotional and dramatic tactics like these have blocked open-minded discussion of the issue. the quality act attempted to challenge these assumptions. 2. aims of the quality act the primary focus of the quality act was not to ensure higher compensa­ tion for physicians. refusing to deny physicians' rights in an attempt to control patient health care costs, the quality act addressed all parties involved in the health care fiasco and sought to secure a fair and equitable process of providing health care. incidentally, the supporters of the quality act argue that by pro­ viding physicians with a voice in the negotiating process, the quality of patient care will increase and the health care costs will be properly valued by the mar­ ketplace. fears of exorbitant or distorted costs alone cannot control the provi­ sion ofhealth care, and professional and personal rights cannot be sacrificed for wishful hearts that want cheap health care for all. such action ignores the real­ ity of the situation, undervalues the premium degree of health care in this coun­ try, and confounds our deepest and most traditional sense of personal freedom in our democratic, capitalist society. furthermore, quality and fees are inextricably related. time is money. services are money. in a capitalist society, everything is money, and everything is valuable. an attempt to constrain costs, is, by definition, an attempt to con­ strain quality patient care. to blindly focus on securing cheap prices and allow detached corporate businessmen to dictate how to constrain costs and cut re­ sources would be a giant mistake ofbrobdingnagian proportions. cheap prices reflect low quality from low cost services. health care services have defined values that can be measured by the marketplace, and any cutting of costs be­ yond the appropriate value of a service is no longer the elimination of wasteful spending, but rather is the voluntary and inane wielding of a scalpel upon nec­ essary and useful aspects of health care. from the obscure and distorted side line viewpoint, it is not easily known whether the businessmen are making smart decisions that enhance and improve the quality and provision of care. however, given that the fundamental maxim of any business is to maximize profit, a financially focused and money driven businessman will choose to sacrifice a higher quality of care for a lower quality 74 !d. 450 indiana health law review [vol. 4:435 of care ifhe can do so without losing business. in contrast, a directly interested and enabled physician. with interests more closely aligned with the patient, would serve as a better mechanism to voice patient demands, fight for the high­ est quality of patient care, and argue against harmful cost constraints that prom­ ise hmos money while denying patients the hope of health. c. state antitrust exemptions for lilliputian-/ike physicians 1. specific state legislative enactments states have enacted legislation explicitly giving physicians the authority to bargain collectively or negotiate with hmos. the texas statute, a model ex­ ample of this type of legislation, is one of the more comprehensive efforts to address this issue, with numerous other states proposing similar legislation with minor differences. 75 texas senate billl468 allows physicians to jointly nego­ tiate with health plans on compensation grounds so long as the health plan in question is deemed by the attorney general to hold a significant market share. 76 unfortunately, "the complexity of the rules ... coupled with the tediousness and cost of the application to request to bargain with the health plan, led to a rarely utilized process .... "and no impact. 77 furthennore, a sunset clause con­ tained in the statute terminated its effectiveness on september 1, 2003.78 similarly, alaska senate bil1256 allows for joint negotiations over fee­ based contractual provisions if a health plan or hmo is found to have substan­ tial market power. 79 california senate bill2007 presumes "all third-party pay­ ers [of hmos] in the state have significant market power'' and, therefore, allows collective bargaining for physicians and requires hmos to fmance any costs the state incurs to institute collective bargaining by physicians. 8° florida 15 see 2000 legislation: physician collective bargaining initiatives: department of st~te government relations november 30, 2000, am. nursesass'nnursing world, avail­ able at http://www.nursingworldorglgova/state/2000/phyco.htm; see also fred j. hellinger & gary j. young, an analysis of physician antitrust exemption legislation: aqjusting the bal­ ance of power, 286 j. am. med. ass'n 83, 83 (2001) (stating that in 2000, congress, eighteen state legislatures, and the district of columbia introduced legislation that would grant physi­ cians an antitrust exemption). 76 see v. denise rose, comment & note, the texas collective bargaining statute: giving a toothless statute some bite, 4 hous. j. healrn l. & pol'y 87, 99 (2003). 77 /d. at 90-91; see also id. at 115 n.20 ("as of april2001, only two physician groups had submitted applications to the attorney general's office to 'collectively negotiate."'). 78 ld at91. 79 see senator pete kelly, alaska state legislalljre, frequently asked questionscssb 256 (rls): physician negotiations wi1hhealtii1nsurers (2000), avail­ able at http://www.akrepublicans.org/pastlegslfaqsb25604192000.htm. 80 newsletters: state legislative update, nat'lass'nofhealrnunderwriters, mar. 20-24, 2000, available at http://lobby.la.psu.edu/01 0 _insuring_ the_ uninsured/organizational­ statements/nahu/nahu _ 032000.htm. 2007] providing physicians wrm a magnified voice to counter hmo 451 house bill1589 provides for collective bargaining over certain contract provi­ sions, while other states, including rhode island house bill7952 and west virginia house bill4604, allowed for collective bargaining or negotiations un­ der specific conditions laid out in legislation. 81 2. preemption problems in granting physicians antitrust exemption status in order to be effective, the state legislation must survive preemption chal­ lenges that would render it unconstitutional. where federal law and state law conflict, the supremacy clause of the united states constitution declares that federal law preempts the field and overrules any conflicting state law. 82 there­ fore, a state law allowing physicians to bargain collectively with hmos will be held unconstitutional as against federal law, in direct conflict with the sherman act, and, consequently, will not survive a preemption challenge. in order for such state laws to be upheld and enforceable, they must fall under the state action doctrine, a common law doctrine established in various prior supreme court cases. 83 in lafayette v. louisiana power & light co., the court stated that in order for conduct to qualify for immunity under the state action doctrine, it must satisfy a two-prong test: (1) the conduct must be pursu­ ant to a clearly articulated state policy, and (2) the policy must be actively su­ pervised by the state. 84 this test was aimed at striking the balance between allowing the states to maintain freedom to administer state regulatory policies free of threat from antitrust laws and preventing purely parochial interests from disrupting the united state's free market goals.85 3. avoiding preemption problems and ensuring antitrust exemption status for physicians by satisfying the state action doctrine the first prong of this test requires the state to "clearly articulate" the state policy that is behind the statute. a "clearly articulated" state policy may be derived from or implied by the language of the legislation. 86 while the clearly articulated prong does not require the language to be expressly stated in the sta­ tute, the state interest must not be as neutral and vague as in the supreme court 81 newsletters: state legislative update, nat'lass'nofhealtiiunderwriters, mar. 13-17, 2000, available at http://lobby.la.psu.edu/010_insuring_ the_ uninsured/organizational­ statements/nahu/nahu 031300.htm. 82 u.s. const. art. vi, § 2. 83 see generally bates v. state bar of ariz., 433 u.s. 350 (1977) (upholding the state action doctrine); see also goldfarb v. va. state bar, 421 u.s. 773 (1975) (addressing the as­ pects of the state action doctrine). 84 lafayette v. la. power & light co., 435 u.s. 389,410 (1978). 85 id. at 415-16. 86 ld. at 410. 452 indiana health law review [vol. 4:435 case of community communications co. v. boulder.81 in boulder, a statute granting general authority to govern local affairs was held as failing to clearly articulate when the state's position regarding regulation oflocal cable television was found to be one of neutrality. 88 in boulder, the court stated that the statute must show "'that the legislature contemplated the kind of action complained of. "'89 while it is impossible to predict and explicitly state all consequences of a statute, the court will not allow states to grant dictator-like governing powers without some sense of direction or evidence of contemplation. the second prong ofthe state action test is whether there is "active super­ vision" by the state of the regulated conduct. this requirement primarily serves the evidentiary function of ensuring that the actor is engaging in the challenged conduct pursuant to state policy.90 a determination of"active supervision" re­ quires an examination of the state's knowledge of the conduct based on its monitoring and its integral role in supervising, facilitating, and even, to some extent, controlling the process. the texas application process for state supervised collective bargaining "requires a copy of contracts with health plans with whom negotiations will take place, income data pertinent to the negotiations, and a set offees to pay the attorney general's administrative costs."91 such burdensome administrative requirements may make completion of the application a one month process92 but clearly errs on the side of evidencing active state supervision. the supreme court has yet to address any of the existing state laws and whether they fall under the protection of the state action doctrine; however, it is important to note that the test is designed to acknowledge legitimate state inter­ ests and allow states to responsibly and sovereignly govern such issues as long as states do not impede on the national scheme. if the court's position on a wp statutes is any indication of how much latitude the court will afford the state in drafting legislation, then states will have the power to enact statutes that are broad in scope, applicable to all or most licensed providers in the state.93 regardless, states must intentionally draft and word their statutes to reflect a narrow, defined intent to govern physician collective bargaining with hmos in order to protect public health and welfare. 87 cmty. commc'ns co. v. boulder, 455 u.s. 40,56 (1982). 88 jd 89 ld. at 55. 90 lafayette, 435 u.s. at 427. 91 guadagnino, supra note 71. 92 jd. 93 see gene a. blumenreich, united states supreme court upholds "any willing pro­ vider" statutes, 71 am. ass'n of nurse anestiietists j., 259, 259 (2003), available at http:/ /www.aana.com/uploadedfiles/resources/legal_ briefs/2003/p259-262.pdf. these laws sought to protect both physicians who might otherwise be excluded from participating in the hmo plan due to the hmos' bias, as well as to ensure that patients would not lose their free­ dom to choose their physicians nor have that freedom of choice be restrained by the hmos' choice of which physicians with whom the patients may contract jd 2007] providing physicians with a magnified voice to counter hmo 453 d. a wp statutes as a popular alternative solution to empowering lilliputian-like physicians 1. a wp statutes defined states have also attempted to combat the weak position of physicians through alternative legislative means. a wp statutes require hmos to permit any physician or health care provider located within the geographically covered area to participate in the hmo plans, so long as the physician is willing to meet the terms and conditions the hmo demands of the other physicians.94 these statutes attempt to provide physicians with power by ensuring them access to any and all hmo plans they may wish to join. ensuring access to a one-sided marketplace, however, does nothing to address its inherent inequity. if any­ thing, it secures and exploits the power ofhmos by subjecting a greater num­ ber of physicians to their brobdingnagian authority. for states interested in restoring control and autonomy of a physician's practice to the physician, such legislation is a misguided attempt and, as time has shown, is generally a moot point. 2. the mccarran-ferguson exception the mccarran-ferguson act "made an exception to the antitrust laws for conduct regulated by a state as 'the business of insurance. "'95 as with many legal issues, this vague phrase required further definition. the court in group life and health insurance co. v. royal drug co. recognized a distinction be­ tween the regulation of "insurers" and the regulation of "insurance" and held ''that third-party provider arrangements between insurers and pharmacies were not the business of 'insurance. "'96 determining whether the relationship be­ tween insurers and physicians was the regulation of"insurers" or "insurance" would determine whether a wp state statutes were constitutional or unconstitu­ tional as preempted by federal law. this question was addressed by the court in the case of kentucky ass 'n of health plans, inc. v. miller.91 the court upheld the statute, stating that a wp statutes "regulated insurance by imposing conditions on the right to engage in the business of insurance. a statute that imposed conditions on the right to be an insurer regulated the [general] 'business of insurance .... "'and not specific insurers. 98 therefore, a wp statutes fall under the mccarran-ferguson excep­ tion to federal regulation and antitrust law. 94 id 95 id at260. 96 group life & health ins. co. v. royal drug co., 440 u.s. 205,210 (1979). 97 ky. ass'n of health plans, inc. v. miller, 538 u.s. 329, passim (2003). 98 blumenreich. supra note 93, at 261. 454 indiana heal til law review [vol. 4:435 insurance companies are likely to be dissatisfied with this result and view the outcome as frustrating their efforts to guarantee volume to current, specific provider physicians who charge insurance companies lower prices in ex­ change.99 in the absence of a wp statutes, hmos can contract with a limited number of physician providers based on a set number of criteria, a practice known as selective contracting. by limiting the number of providers, hmos can reduce overall administrative costs and negotiate lower rates by offering a higher per-physician case load. 100 it is possible, however, that a wp statutes simply change the mechanism for ensuring low prices for insurance companies. where two friendly parties once conspired to trade volume for low prices, now the marketplace, with its increased number of physicians and relatively equal demand, will provide in­ surance companies with comparable low prices and the same upper hand in contracting with physicians. indeed, many states have been hesitant to enact a wp statutes, finding them unnecessary. because employer groups are free to choose insurance companies, insurers must strive to ensure customer satisfac­ tion in a competitive market. as a result, having a large provider network is in the interest of the insurance companies, making such legislation a moot point. not only do these statutes fail to alter the financially dominant position of the hmos but also are a failed and compromised alternative for the simple rea­ son that their primary purpose does not address the problem: the unequal distri­ bution of power between physicians and hmos. while protection from discrimination secures inclusion, it does not secure equality for all of those in­ side that protected arena. statutes must be concerned with and focused on cre­ ating an equality of bargaining power or an avenue to such a position. forfeiting or ignoring this element of equality fails to address the main problem and leaves the health care landscape, and future, unchanged. securing an individual physician's right to be included in the hmo is a serious issue, particularly considering that physicians are becoming increasingly dependant on hmos as a source of income. 101 such dependency becomes a problem when the general power of a physician to negotiate and bargain with an hmo remains absent. misguidedly, a wp statutes address the individual physician and not the ability of all physicians to unify and present a united front to counter the powerhouse position ofhmos. 3. a wp statutes prove to be an inadequate solution to empowering physicians while the outcome of kentucky ass 'n ensures that qualified, willing providers will not be pushed out of the marketplace by the preferential 99 id 100 see id. 101 id. 2007] providing physicians with a ma.gnjfied voice to counter hmo 455 whims and fickle admittance gates of insurance companies, these statutes do nothing to strengthen the position of these physicians in negotiations with the insurance companies. rather, the statutes only ensure that all physicians will have fair access to compete with one another within the realm of the hmo. a redistribution of volume, shifting the gross number of insureds that visit one physician to another, or simply splitting a finite number of in­ sureds among a larger number of physicians does not strengthen the position of physicians. this does not ensure physicians proper compensation or autonomy; it only prevents discrimination. v. dwarfing the brobdingnag and magnifying the voice of the lilliputian a. proposed legislation to enlarge the influence of the lilliputian-like physicians and counterbalance the giant power of geographically dominant hmos specific legislation must be developed and implemented to effectively se­ cure the rights of physicians and counterbalance the monopolistic authority of an hmo that dominates the business ofa particular geographic region. this note proposes that physicians should be authorized to jointly negotiate with health plans in situations in which a small number of health plans substantially dominates a geographically covered market area, as determined by either a sta­ tistical determination or the attorney general's judgment.102 the grounds for this type oflegislation exist within both established case law and employment principles that recognize the need to address unequal positions of bargaining power. furthermore, in order to ensure the effectiveness. of this legislation, states must not impose cumbersome requirements that strangle any attempt to utilize such legislation. rather, states can phrase and shape this legislation to ensure adequate oversight to satisfy state action doctrine concerns without ren­ dering the legislation ineffective. b. a recent nlrb decision laid the foundation for granting physicians the authority to bargain collectively in specific circumstances this proposal upholds traditional legal principles, while also addressing new and current demands that changing times have created. while the general rule that physicians are not exempt from antitrust statutes still applies, the un­ contemplated, modem face of health care does justify carving out a small, but 102 see 2004 competition in healtii insurance, supra note 38. the herfindahl hirshman index could be used to derive an appropriate and meaningful statistical determination. the ftc and doj rely on the herfindahl hirshman index as an important calculation in evalu­ ating the existence or absence of competition in markets, as well as identifying monopolistic presences or where a small number of companies substantially dominate a geographic area. 456 indiana healm law review [vol. 4:435 appropriate, exception. the judiciary has only commented on the relationship between independ­ ent physicians and hmos once before, and then only through the voice of a regulatory board.103 inamerihealth inc. & united food & commercial work­ ers union, local 56, afl-cio, the petitioning physicians were attempting to form a proposed bargaining unit to represent the interests of physicians em­ ployed by amerihealth in atlantic and cape may counties ofnew jersey. 104 this bargaining unit would present a unified front in voicing the interests and demands of physicians employed by amerihealth during contract negotiations with the corporate powerhouse, amerihealth. the nlrb ruled to dismiss the ''petition on the ground that the peti­ tioned-for physicians are independent contractors" and not de facto "employ­ ees,'' which would have given the physicians the right to bargain collectively with amerihealth. 105 indeed, while the nlrb in amerihealth ruled that cer­ tain factors did not amount to considering physicians as de facto employees of health plans, the board's language in balancing the factors and considering the physician's employee argument indicates that certain circumstances could arise where such a de facto status would be recognized and the right of physicians to bargain collectively could exist.106 c. identifying the specific circumstances that would authorize lilliputian­ like physicians to bargain collectively with dominant hmos the nlrb inamerihealth followed the precedent of the supreme court and applied the common law of agency to determine whether the particular physicians involved constituted "employees" or "independent contractors."107 this common law analysis, phrased in the words "servant" and "master,. re­ spectively, examines the following factors: (a) the extent of control which, by the agreement, the master may exercise over the details of the work; (b) whether or not the one employed is engaged in a dis­ tinct occupation or business; (c) the kind of occupation, with reference to whether, in the locality, the work is usually done under the direction of the employer or by a specialist without supervision; (d) the skill required in the particular occupation; (e) whether the employer or the workman supplies the 103 amerihealth inc., 329 n.l.rb. 870,passim (1999) (addressing the claim of652 physicians in october of 1999). 104 id. at 870. 1os id. 106 id at 884-85. 107 id. at 882. 2007] providing physicians with a magnified voice to counter hmo 457 instrumentalities, tools, and the place of work for the person doing the work; (f) the length of time for which the person is employed; (g) the method of payment, whether by the time or by the job; (h) whether or not the work is a part of the regular busi­ ness of the employer; (i) whether or not the parties believe they are creating the relation of master and servant; and (j) whether the principal is or is not [in] business.108 while all factors are relevant and none is singularly dispositive, the nlrb's analysis focused heavily on the control exerted by the employer over the "em­ ployee." relying heavily on the theory that servants have a very close eco­ nomic relation with their employers and are subject to their employers' control, the nlrb suggested that factor (a), the "control factor," may be most indicative of a judicial ruling. 109 the nlrb stated that a primary legal issue at stake was to determine "whether the physicians, in their work for amerihealth, [were] so integrated with and controlled by amerihealth that they [met] the statutory definition of employees ... [or] servants. " 110 as a result, the nlrb requested an investiga­ tion into the amount of control and the intimacy of the relationship between the physicians and amerihealth.111 the investigation revealed that amerihealth did control, or had the right to control, many details of the services physicians deliver to amerihealth members, including whom a physician is required to treat. 112 amerihealth also imposed personal standards on physicians, "such as the maximum number of patients a physician may see in an hour, the size of the patient waiting room and the maximum amount of time a patient may be kept waiting there. " 113 in addition, amerihealth employed on-site visits, credential­ ing, and status standards to monitor physicians and ensure they were living up to amerihealth's standards. 114 ifthe physicians failed to perform to amen­ health's specific standards, amerihealth had the right to terminate the con­ tract.115 this exhibits a strong degree of authority and control in the 108 /d. (citing restatement (second) of agency§ 220 (1958)). 109 /d. at 883. 110 /d. ill /d. 112 /d. (demonstrating that "physicians must accept and treat amerihealth members who select the physicians or are referred to them," and that this arrangement continues indefinitely until either amerihealth terminates the arrangement or the physician overcomes his fear oflos­ ing patients and chooses to terminate the arrangement). 113 /d. 114 /d. 115 /d. 458 indiana health law review [vol. 4:435 relationship, causing the significant "control factor'' of the common law of agency test to weigh in favor of servant status. 116 while the nlrb acknowl­ edges that this oversight is not extensively exercised by amerihealth, it also acknowledges that the "control factor" of the common law agency test exam­ ines a master's right to control, not his actual exercise of control.117 in speaking to both factors (a) and (c) of the common law of agency test, the nlrb commented on the lack of oversight performed by amerihealth and noted that physicians are not required to practice under the actual eye of a su­ pervisor. 118 the nlrb did state, however, that being a "servant" does notre­ quire an individual to be physically under the control of another.119 rather, "[ m ]any servants perform exacting work requiring intelligence rather than mus­ cle."120 therefore, while acknowledging that amerihealth is not physically controlling the physicians, the nlrb is recognizing the structure of the rela­ tionship and the intangible degree of control amerihealth exercises over the physicians. the nlrb continued its focus on the "control factor" by noting that "[ m ]any, if not most procedures performed by the physicians currently require no precertification" or pre-approval from amerihealth.121 the intangible as­ pect of the situation, however, reveals amerihealth's true control over the phy­ sicians. while amerihealth may not actually require physicians to obtain permission for the majority of their activities and procedures, a physician's de­ cision-making process may be severely influenced and constrained by the vari­ ous financial incentives, procedural standards, and blatant expectations amerihealth has enforced through its contract. the alternative options available to the physicians may have been most decisive in the board's decision. undermining the physicians' argument of intangible control, amerihealth's market share is less than ten percent of the insured population for its coverage area. 122 in addition, the physicians were free to contract with other insurance companies. 123 even though a physician may risk losing hmo-amerihealth insured patients by contracting with other insurance companies, hmo-amerihealth' s market share is not so dominant as to seriously jeopardize the physicians' access to other patients. furthermore, the nlrb concluded that the physicians had a ''meaningful opportunity'' to negotiate the· terms of compensation and standards with hmo-amerihealth, based on the fact that hmo-amerihealth has negotiated special rates with ten 116 see id. 117 /d. 118 /d. 119 see id. 120 /d. (noting that officers of a corporation or a ship, interns at a hospital, and janitors performing manual labor are all considered servants). 121 /d. at 884. 122 !d. 123 !d. 2007) providing physicians wrm a magnified voice to counter hmo 459 percent of its physicians.124 in contrast, situations in which physicians are con­ tinually denied revised compensation rates and standards could indicate a lack of voice, unfair bargaining, and excessive control by the hmo. also weighing against a finding of excessive control by amerihealth over the physicians is the fact that the physicians practice medicine in their own name, not amerihealth's, and are highly skilled professionals with a high de­ gree of autonomy over their practice.125 while that reasoning may have been valid in this particular situation, the nlrb and state legislatures must acknowl­ edge that intellectual and individual professions are also subjected to the con­ trol and whims of larger, brobdingnagian forces, especially in today's health care world where large hmos contain costs by constraining physician prac­ tices. indeed, the nlrb leaves open the possibility of finding servant status due to excessive and coercive intangible control in the physician-hmo rela­ tionship by issuing a narrow ruling specific to the facts of the case;126 even though the nlrb rejected that the particular physicians were de facto employees, it indicated that a physician might be considered a de facto employee if the hmo's control is so excessive and prevalent as to dictate the actions of physicians.127 while this is a fact sensitive inquiry, such situations are more likely to occur where hmos substantially dominate market share. these environments establish a fertile ground for excessive power for hmos and foster a vulnerable position for powerless physicians. the nlrb contrasts the position of the physicians with an illustration of a photographer who is employed by a newspaper to take pictures.128 upon taking the pictures, the photographer is not allowed to sell his work to the employer's competitors and is therefore bound to the newspaper alone and completely sub­ ject to it.129 instead, the nlrb sees the position of the physicians more like that of a freelance advertisement photographer who contracts with an advertis­ ing agency.130 despite being monitored and supervised by art directors to achieve the agency's desired result, this photographer, as a highly skilled pro­ fessional, is given autonomy over the technical means chosen to carry out the art director's instructions.131 if tweaked in one of two ways, however, this illustration could lead to a different conclusion. first, if the contract establishes the right and ability of the art director to substantially influence and control the photographer's autonomy, whether that right is exercised or not, then the photographer has essentially con­ tracted himself into the position of a servant. second, in a situation in which 124 see id. 125 ld. 126 see id. at 885. 127 see id. 12s id. 129 id. 130 !d. 131 ld. 460 indiana heal til law review [vol. 4:435 only one or two advertising agencies exist and substantially dominate the mar­ ket, the freelance photographer's ability to operate his own business is signifi­ cantly destroyed. the freelance photographer is then freelance in name only. he has no other advertising agency to offer his business. the reality of the situation is that he is just as dependent on the dominant, monopolistic advertis­ ing agency as the newspaper photographer. proposed state legislation should identify and articulate the circumstances that would give rise to such a de facto status and give physicians the right to jointly negotiate with health plans. indeed, this is the very role of the legisla­ ture to listen to the needs of its people and the demands of changing times and implement adequate regulation in response. should the state improperly legislate, it is the role of the judiciary to clarify its position and judge the legis­ lation improper. for the time being, however, the judiciary has left this area of law open to legislative action. d. learning from the mistakes of prior legislative attempts and effectively crafting the proposed legislation 1. ensuring adequate state oversight and satisfaction of the state action doctrine five years after the onslaught of pro-physician legislation, states now have the opportunity to learn from the mistakes and pitfalls of prior legislative at­ tempts. nowhere is this more true than in the realm of adequate state oversight, as required under the state action doctrine. in their attempts to secure adequate oversight to ensure the constitutionality of the legislation under the state action doctrine, states have employed requirements that have strangled the process and choked-off any potential power to physicians. two common flaws have pla­ gued past legislation: (1) the length of the application review process, and (2) the role of the government, specifically the attorney general, in conducting the negotiations between physicians and hmos. a lengthy application review process only results in significant delays, sometimes spanning years, and discourages physicians from participating in the process.132 a brief time period must be established in order to secure not only the practicality and effectiveness of the process but also to communicate strong support for the physicians and patients who are directly affected by the con­ tracts hmos form with physicians in the geographic area. in addition, states must secure the validity of the process of collective bar­ gaining itself by keeping it within constitutional constraints. prior legislation made the mistake of requiring the state attorney general to serve as the oversee132 see rose, supra note 76, at 105-06 (noting that the " 'expensive and time-consuming application' process" in texas renders it ineffective, as well as the risk that insurance companies may refuse to bargain after physicians are approved). 2007] providing physicians with a magnified voice to counter hmo 461 ing authority of negotiations in order to avoid antitrust law violations and sat­ isfy state oversight qualifications for the state action doctrine. antitrust law and oversight concerns, however, do not require that a governmental third-party be present to facilitate, mediate, or arbitrate every negotiation. 133 instead, the actual requirement is that a governmental third-party be the intermediary be­ tween the two bargaining parties. 134 alternatively, this requirement can be ade­ quately fulfilled by disclosing information and the details of the bargaining meetings. examples of avenues for such disclosure include the initial applica­ tion, filing requirements of negotiation activities and minutes, and establishing a proper complaint procedure for hmos that believe negotiations are occurring contrary to the statute. 2. focus on collective bargaining, not arbitration some advocates of pro-physician legislation suggest arbitration as an ef­ fective means of securing physician rights and demands in the health care in­ dustry.135 in this scenario, an arbitrator would be free to select between the physician group's proposed solution or demand, and leave the current hmo regulation or fee in place. 136 while an arbitrator would certainly bring the par­ ties to the table and promise some definitive resolution to the issue, this type of legislation does not address the key concern presented by the situation: the physician's lack of voice and bargaining power. 137 furthermore, the dimension of finality involved in the arbitration process, as opposed to collective bargain­ ing, may force physicians to significantly compromise their demands for fear of hmos denying their solutions in the ali-or-nothing atmosphere of arbitration. such a process will fail to secure the rights of physicians to voice their strongest demands directly at the feet ofhmos. rather, such legislation is a harness on the physicians' attempt to truly demand solutions and changes from hmos. further, state and federal legislation must be aimed at ensuring a fair and equitable process for determining procedures and contracts in the health care industry and nothing more. for example, hmos should still be capable of util­ izing their strengths in conducting negotiations. such legislation should not place the rights of a physician above the hmo and attempt to find binding ways to ensure health care reform. rather, it is more important, valuable, and appropriate that legislation focus on securing an equitable forum of discussion where all parties are represented and their demands are heard. this forum is 133 /d. at 111. !34 /d. 135 /d. !36 /d. 137 see id. advocates of arbitration note that the dimension of finality involved in arbitra­ tion would make it unlikely for physicians to propose unreasonable demands on hmos. as a result, physicians are likely to propose only reasonable and realistic solutions that hmos are willing to consider, increasing the chances of the parties coming to a consensus. id. at 112. 462 indiana health law review [vol. 4:435 responsible for securing just and fair results, not government legislation, and this understanding must not be compromised. an attempt to radically secure the rights of physicians may result in nothing more than a shift of monopolistic power from one side to the other. the provision of a balanced and more equal bargaining environment, however, fosters a solution that will address shortcom­ ing and concerns of all parties involved. 3. require good faith bargaining.from hmos under federal law, collective bargaining typically requires communication and negotiations between the employer and employee.138 an employer's re­ fusal to meet with employee groups at reasonable times or to discuss mandatory or crucial issues of concern is considered unfair labor practice. 139 logically, hmos should be bound by this same duty. the focus, however, must be on the good faith efforts of the hmo to bargain with physician groups. it is important that the duty of the hmo be couched in the principle of good faith and not an explicit requirement to sit down at the negotiating table as some pro-physician advocates would suggest. an express, mandatory requirement on attendance at bargaining sessions not only falls short of the desired outcome but also creates an even more hostile and dramatic environment by pitting two unwilling sides against each another. in contrast, a focus on requiring hmos to conduct collective bargaining in good faith would foster a positive atmosphere for communication and also provide broader legal grounds for ensuring hmos' participation in the bargain­ ing process. narrow and express mandatory provisions leave room for loop holes that can be exploited by creativity. for example, a requirement of manda­ tory attendance at bargaining negotiations does not expressly state what com­ pany employee must be present. for example, hmos could possibly satisfy such a hostile requirement simply by sending the ceo's secretary. on the other hand, however, it is unrealistic to require the company president to attend every bargaining meeting, particularly when multiple meetings may be occur­ ring in multiple locations at the same time. therefore, extending a good faith bargaining requirement to hmos would allow courts to properly consider the context and facts of a situation in determining whether physicians are being denied their right to voice demands and solutions, whereas narrow and strict requirements only encourage hmos to find ways to escape the bargaining process. e. predicted impacts from implementing the proposed legislation the primary results of this legislation would affect three main issues: (1) 138 id at 108. 139 id. 2007] providing physicians with a magnified voice to counter hmo 463 competition in the health care industry, (2) quality of patient care, and (3) health care costs. the implementation of this type oflegislation has the poten­ tial to improve the quality of patient care and maintain current health care costs while increasing competition in the health care industry. the following sub­ parts examine the arguments and assumptions that underlie these issues. 1. increased competition and justice for physicians through a balanced playing field the proposed legislation will inject a healthy dose of competition into geographic areas in which hmos face no competition from other hmos and are able to subject physicians to meager reimbursement rates and dictate terms of patient care. america has relied on the concept of free market competition in the vast majority of the economy's rnarkets. 140 indeed, the sherman antitrust act was enacted to preserve competition in the free market and has been hailed the magna carta of free enterprise. 141 over the past century, the competition of the free market has driven innovation, provided choice, and lowered prices.142 indeed, the economic vitality of the nation depends upon the competitive struc­ ture of a health care industry. 143 joel klein, assistant attorney general for the department of justice, stated that the ''ultimate goal is the preservation of corn­ petition at all levels of the health care industry."144 rep. torn campbell, state house representative for california, described the current lopsided, competitive structure of the health care industry by stating that ''what we have today is muscle. and i have got muscle on my right arm, and i am trying to put muscle on my left."145 giving physicians the muscle and a voice to counteract the powerhouse hmo position will result in a more equi­ table distribution of profits between the hmo and physician, create market penetration opportunities for smaller competing hmos in regions where physi­ cian choice was prohibited before, and create more choices for patients through diversified physician-hmo relationships and market-encouraged innovation. the most important result of such legislation, however, may be lost in all the data and theory. this legislation would support the principles ofliberty and personal autonomy that are so deeply rooted in our nation's history and values. whether regarding economics or public health, our courts have always been weary to tread on the personal liberty and freedom that was first established by the constitution. indeed, the free marketplace touts the success ofthe individ­ ual entrepreneur, and due process aims to protect people from anything short of 140 quality health care coalition act, supra note 33, at 70. 141 id 142 id 143 id (stating that in 1997 the "annual revenues ofhealth care professionals covered by the sherman act ranged between $300-400 billion, about 4-5% of gdp"). 144 /d. at 73. 145 !d. at 109. 464 indiana heal til law review [vol. 4:435 necessary government regulation. the current situation allowing limos to ex­ ercise such dominance and authority over physicians cannot be reconciled with a devotion to these principles. no matter what the monetary savings, compro­ mising these principles is far more costly and unacceptable. lffear exists among limos that allowing physicians to have a voice in the practice of their profession will result in higher costs to consumers, then legisla­ tures must provide consumers with a voice and thereby seat all three affected parties at the table. the answer is to invite, not exclude, more voices and more parties to the table. the omission of such voices, including that of the physi­ cians, is a compromise that cuts comers and results in an inadequate and unjust result, similar to how hmos compromise quality of patient care and the right of physicians to exercise full autonomy in their practices in order to reach the de­ sired result of lower costs and higher profits. the answer to consumer fears is to allow for inclusion in the process and to secure a forum for discussion that will facilitate the most honest and equitable result physician rights that are continually denied and limited, however, will confine the industry to its current imbalance and inadequacies. some measures have been taken, such as consumer directed health plans ("cdhps") and a patient bill of rights, to give consumers a seat at the table; however, these efforts are incomplete as long as they are not coupled with this type of proposed legislation. "cdhps rely upon consumer decision support tools, including extensive use of data comparing providers, to influence con­ sumer relationships with providers. "146 these plans attempt to give consumers control over their health care insurance money and provide adequate informa­ tion about physicians, hmos, and medical services to enable them to make in­ formed decisions on how to spend this insurance money.147 such plans attempt to make consumers their own advocates and allow physicians and hmos to compete in a free market for their business. indeed, the emergence of cdhps gives consumers a voice and power to counteract hmos. meanwhile, a patient bill of rights would establish a list of explicit rights that provide grounds for patient claims and an avenue for judicial attention. while such solutions may strengthen the role of the consumer, such activism by itself does not address the injustice burdening physicians and actually works to further weaken their posi­ tion and voice. physicians would then be the sole party excluded from exerting an influence in the provision of health care in america. 146 edward f. shay, physician impacts of consumer-directed health plans, physician's news dig., jan. 2006, available at http://www.physiciansnews.com/business/106shay.html. 147 see id. ("cdhps typically describe a benefit scheme with the following characteris­ tics. first dollar coverage under a health benefits policy with generous benefits is replaced with a combination of a health savings account and a high-deductible catastrophic benefits policy, often geared to selected provider networks. the health savings account is akin to a medical ira. it offers tax advantaged, self-managed funding for health care up to about $5,500 annu­ ally."). 2007] providing physicians with a magn1fied voice to counter hmo 465 2. the impact on health care costs and subsequent economic conse­ quences the primary criticism of this legislation is that it would raise costs and en­ courage the very problem that hmos were established to address.148 oppo­ nents claim that higher fees for professional services would be passed onto consumers and result in higher prices for health insurance coverage. 149 this assertion is based on the assumption that limos will choose to pass on in­ creased costs in the form of higher prices for health care insurance. this is not a mandatory result of allowing physicians to negotiate with hmos, and to the extent it is a likely result, it is merely a reflection of the primary motivating fac­ tor ofhmos: monetary profit. while such legislation may lead to a redistribu­ tion of profits, with the hmos retaining less and the physicians receiving more, the hmo will still make a degree of profit.150 indeed, this is certain because it would be against the interest of the physicians to negotiate for such a high amount of compensation that would cause the hmo to go out of business. physicians need hmos, just as hmos need physicians. therefore, the real issue is whether the hmo chooses to recapture the redistributed profits by charging consumers higher prices. 151 some believe hmos will undoubtedly choose to recapture lost profits by passing the costs onto the consumers and patients. even this claim, however, acknowledges the abusive degree of power hmos currently hold. essentially, this argument asserts that hmos are parties with unfettered market power that will use that power as any rational business­ person would to make money. 152 this emphasizes the hmos' primary objective of making a profit, wheth­ er at the expense of the consumer or by cutting the quality of health care.153 this self-interested motivation and perspective is the very characteristic that is attributed to physicians and that critics of this type of legislation say prevents physicians from fairly negotiating with hmos. if the hmo's primary objective was to cut costs to the consumer, as touted by the press and industry, profit would not dictate its decisions; rather, costs would. therefore, an hmo should be operating as a nonprofit entity and not a profit-seeking, consumer-gouging entity. while it is unlikely this conversion will take place, the introduction of physicians to the negotiating table would counter this coercive force. the best method of cost constraint is not a one-party dictatorship; it is a competitive marketplace with competing interests that forces innovation, cre­ ates choice, and lowers prices. 154 this is the basic economic lesson that encour148 see quality health care coalition act, supra note 33, at 77. 149 /d. at 78. jso see id. at 34-35. lsi id. 152 see id. 153 /d. at 27. 1s4 id. at 70. 466 indiana heal1h law review [vol. 4:435 ages low costs in every other american industry. the initiation and preserva­ tion of competition in the health care industry is the key to limiting costs and begins by allowing a second party, the physicians, the voice to counter the brobdingnagian presence ofhmos. finally, while it may not be pleasant for hmos or consumers, any result in increased costs would not be due to physician greed but rather due to the honest valuation of the procedure by the marketplace. america provides health care options that are among the best in the world and simply were not available even decades ago. 155 paramount health care at a low cost simply is not the real­ ity. it reflects a mismatch of expectations in the minds of the average ameri­ can.156 requiring world-class procedures at discount rates is costing physicians their practices and robbing regions of their doctors. it is not fair for one party to carry this burden. it should be redistributed among all parties involved, es­ pecially the brobdingnag-like hmo. 3. an improved quality of patient care the primary objective of a physician is to treat and heal patients with a compassionate nature and a respect for human dignity and rights.157 as a stock­ driven, profit-seeking corporation, the primary objective of an hmo is to make money. 158 in fact, the hmo business paradigm is to make up for lower costs by directing a higher volume of patients to the same number of doctors.159 "this business model intrinsically sacrifices personal attention to patients and puts quality of care injeopardy."160 as a result, hmos are less than ideal advocates for patients and increased quality of care. the role of the physician is much more closely linked to the interests of the patient and makes for a more effective patient advocate. the financial structures of many hmos are not driven by patient need. if an hmo is not providing a service because it is not as profitable as an alterna­ tive or it takes up time and money when a physician could be seeing another patient, the hmo is sacrificing the quality of treatment to make a profit. 161 physicians are rewarded for seeing more patients in less time and providing fewer services. it must be recognized that "fees and quality are inextricably related."162 by allowing physicians to negotiate for performance based com­ pensation, as opposed to volume based compensation, compensation will be 155 id at 89. 156 id 157 am. med. ass•n. principles of medical ethics. http://www.ama-assn.org/ama/pub/category/2512.html qast visited apr. 13. 2007) (adopted june 17. 2001 ). 158 quality health care coalition act, supra note 33. at 27. 159 /d. at 26. 160 id 161 id 162 id at 139. 2007) providing physicians with a magnified voice to counter hmo 467 directly linked to patient needs and care. not only will physicians be able to negotiate for better financially structured relationships but also will be able to influence the appropriate standards of care. in contrast, hmos currently choose to employ some industry standards but often create their own standards and specific expectations of a physician's practice. this practice of hmo­ created standards and the influence it exerts on a physician's practice could threaten the quality of care patients receive by rooting the standard of physician care in the hmo's corporate objectives, as opposed to the patient's needs or physician's opinion. furthermore, such decreased quality of care may not be actionable under medical malpractice statutes if the decline is pervasive throughout the industry, as is entirely possible with the dominant and omni­ present influence ofhmos. given that medical malpractice claims rooted in negligence are largely based on a physician's adherence to the customary stan­ dard of care, a comprehensive decline in the quality of care would simply repre­ sent a new, lower industry standard of care. more important than industry standards or negligence claims, however, is that this echoes the fundamental and continual problem ofhow brobdingnag-like hmos have the power to bully the practices and lives of lilliputian-like physicians. vi. conclusion this note, in part ii, examined the history of an employee's right to col­ lectively bargain with employers, as well as a physician's right to collectively bargain with hmos. part iii addressed the changing landscape of health care in the united states, and part iv examined attempts taken by various states, doctors, and the federal government to address the needs of powerless physi­ cians against hmos. finally, in part v, this note proposed a solution that would properly extend physician rights and empower physicians to seek fair and equitable arrangements with hmos wherever a brobdingnag-like hmo structure is found. through consolidations and a blindingly narrow focus on constraining costs, the current state of the health care industry places physicians in a lillipu­ tian-like position. small and voiceless, physicians are simply outmatched by the sheer dominance and force asserted by brobdingnagian hmos. unlike in gulliver's travels, however, these two contrasting populations live in the same world. as a result, legislation is necessary to facilitate communication and co­ operation among these diverse cultures with their divergent interests. further­ more, such legislation would secure an improved quality of care for the patients who are indirectly affected by the feuding civilizations. a failure to address this situation may result in the extinction of the independent physician practice as it currently exists. where an hmo substantially dominates a geographic market, physicians are subject to the force and size of the hmo, resulting not only in unfair rates and arrangements, but also an inequitable process that denies physicians the voice and right to make adequate and professional demands. rooted in princi468 indiana health law review [vol. 4:435 pies of autonomy and freedom, and expressly against monopolies and restrained trade, the legal system must respond. physicians deserve and demand legisla­ tion that will secure an equitable and open forum for negotiation and contract formation. furthermore, a forum of this nature would recognize and validate the self-evident rights of physicians to voice their opinions against corporate powerhouses and also strive to advocate on behalf of the patient's absent voice for increased quality care. as a result, it is imperative that states acknowledge the wayward inequity allowed by current law and remedy it through legislation. such legislation should identify geographic regions in which hmos exhibit a monopolistic authority and then empower physicians with an equal authority to unite and bargain collectively with the brobdingnagian hmos. toward a twenty-first century civil commitment statute: a legal, medical, and policy analysis of preventive outpatient treatment rachel a. scherer• i. introduction ............................................................................... 362 ii. the evolution of pvot: a civil commitment statute ...... 363 ill. recent scientific and medical advancements concerning severe and persistent mental illness .................................. 371 a. what constitutes a severe and persistent mental illness? ...... 371 b. genetics and the environment ................................................. 3 73 c. cognition and insight .............................................................. 375 d. violence .................................................................................... 316 e. medication and other forms oftreatment ............................. 379 n. robert's story: a human face to the f allures of the danger-or-ora vb-disability statutes .................................. 382 a. robert's chances for treatment under a typical danger-orgrave-disability statute ........................................................... 383 b. robert's chances for treatment under a pvot statute ......... 384 v. the language of the model pvot statutes: kendra's law and laura's law ......................................................................... 385 a. kendra's law ofnew york ...................................................... 386 i. eligibility requirements .................................................... 386 2. third parties that may petition the court to determine eligibility ........................................................................... 391 b. laura's law of california ....................................................... 393 i. eligibility requirements .................................................... 394 2. third parties that may petition the court to determine eligibility ........................................................................... 395 vi. jurisdictions that have modeled legislation after kendra and laura ..................................................................................... 396 a. enacted pvot statutes ............................................................ 396 b. other jurisdictions transitioning to add pvot .. .................... 398 vii. constitutional analysis of pvot statutes ........................ 401 • j.d., 2007, indiana university school oflaw, indianapolis, indiana; b.a., 2003, uni­ versity ofpennsylvania, philadelphia, pennsylvania. questions and comments may be directed to the author at rscherer@alumni.upenn.edu. i would like to thank three people without whom this note would not be where it is today: clare maier, for her countless and thoughtful edits of this note; rusty seli:x, for his assistance in clarifying key aspects of california mental health law; and professor r. george wright, for his numerous edits, suggestions, and research ideas, and for challenging me to think critically, objectively, and abstractly on this particular topic. 362 indiana health law review [vol. 4:361 vlll. reportsanddataontiieeffectsofpvotstatutes ......... .407 a. what types of severely mentally ill persons-and how manyare being treated under pvot? ........................................... .409 b. how long are pvot treatment orders lasting: are patients complying with their medication and treatment plans under pvot? ..................................................................................... 410 c. what are the effects ofpvot on incarceration rates? ........ .413 d. what are the effects ofpvoton rates ofhomelessness? ..... .415 e. other benefits ofpvot ........................................................... 418 ix. the trutii behind laura's law-the california ghost law ................................................................................................ 419 a. proposition 63: the mental health services act .................... .426 x. alternatives to pvot ............................................................... 428 a. mental health courts as criminal diversion programs ........ .428 b. rebuilding and expanding inpatient hospitals ..... ................. .429 c. improving awareness and education of severe mental illness through early prevention ........................................................ 431 d. comprehensive voluntary services programs ........................ .432 xi. conclusion .......................................•................•.....................•... 433 i. introduction chronically and severely mentally ill persons present unique challenges for society. for centuries, legislatures have sought to address the conundrum of protecting the public from harm caused by severely mentally ill individuals, as well as the harm severely mentally ill individuals may cause to themselves, while commensurately protecting the civil liberties of such individuals. finding a balance between these competing interests is not an easy task and remains unsettled. a new type of civil commitment statute called ''preventive outpatient treatment" ("pvot'') 1 offers a promising solution. the media coverage surrounding the adoption ofpvot statutes in new york and california in 1999 and 2002, respectively,2 has led to increased atten­ tion to pvot statutes since the tum of the twenty-first century. 3 several states 1 see infra part it notes 35-39 and accompanying text for a discussion as to why the author chose to call these statutes pvot rather than aot. 2 kendra's law, ch. 408, 1999 n.y. laws 2870 (codified at n.y. mentalhyg. law§ 9.60 (mckinney 2006)); assisted outpatient treatment demonstration project act of 2002 ("laura's law"), ch. 1017,2002 cal. legis. serv. 5046 (west) (codified at cal. weif. &inst. code§§ 5345-5349.1 (west supp. 2007)). 3 see michael l. perlin, therapeutic jurisprudence and outpatient commitment law: kendra's law as case study, 9 psychol. pub. pol'y & law 183, 184 (2003). the virginia tech massacre also brought significant media attention toward pvot. e. fuller torrey, com­ mitment phobia, wall st. j., apr. 27,2007, ata17 (citing kendra's law) [hereinafter torrey, 2007] toward a twenty-first century civil commitment statute 363 have since modeled their own pvot statutes after those ofnew york and cali­ fornia.4 florida and michigan, for example, have done this as recently as 2005.5 additionally, pvot statutes are gaining an international status and at­ tention, with increasing endorsements from mental health associations and agencies, such as the treatment advocacy center, 6 the american association ofpsychiatrists, and the national institute for mental health.7 this note undertakes a critical review ofpvot statutes through the two most prominent current pvot statutes, new york's kendra's law and cali­ fornia's laura's law. 8 the focus will be on discussing these statutes' basic statutory language and purposes, the latest statistical reports regarding effec­ tiveness, relevant case law regarding their usage, and the constitutional debates that surround them. pvot statutes offer a promising and much needed update to state civil commitment statutes. nonetheless, pvot may not be the only option, or even the best one, to improve the united states' mental health care system. more research needs to be conducted before we can reach any definitive conclusion concerning pvot. yet in some shape or form, pvot statutes seem bound to leave a lasting imprint as we move toward increasingly health-care-conscious civil commitment statutes. ii. the evolution of pvot: a civil commitment statute mental illness has historically been misunderstood, misdiagnosed, and mistreated. 9 isolation, hydrotherapy, insulin coma therapy, convulsive theracommitment phobia]. it appears the earliest pvot statute (similar in form to that which this note addresses) was enacted by north carolina in 1983. see n.c. gen. stat. §§ 122c-261(axii), 122c263(dxl) (2005); jennifer honig & susan stefan, new research continues to challenge the need for outpatient commitment, 31 new eng. j. on clum. & civ. confinement 109, 110 (2005). hawaii also enacted a pvot statute before 1990, which is also similar to those pvot statutes this note addresses. see haw. rev. stat. ann. § 334-121 (lexisnexis 2004). e.g., john k. cornwell & raymond deeney, preventive outpatient treatment for persons with serious mental rlness: exposing the myths surrounding preventive outpatient commitment for individuals with chronic mental rlness, 9 psychol. pub. pol'y & l. 209, 213 & n.28 (2003); erin o'connor, note, is kendra's law a keeper? how kendra's law erodes fundamental rights of the mentally ill, 11 j.l. &pol'y 313, 322 & n.34 (2002). 4 see infra part vi.a. 5 id. 6 the treatment advocacy center drafted the model pvot legislation. treatment aovoc. ctr., model law for assisted treatment (2000), available atwww.psychlaws.org/­ legalresources/modellaw.htm [hereinafter'i'rea'iment aovoc. cir.,modellawforassisted treatment]. 7 e.g., treatment advoc. ctr., http://www.psychlaws.org (last visited mar. 9, 2006). 8 honig & stefan, supra note 3, at 110-11. see also mark fritz, a doctor's fight: more forced care for the mentally ill, w au. st. j., feb. 1, 2006, at ai. 9 see, e.g., sarah linsley starks & joel t. braslow, the making of contemporary american psychiatry, part i: patients, treatments, and therapeutic rationales before and 364 indiana heal til law review [vol. 4:361 pies, lobotomies, and sterilization were some of the radical and misguided treat­ ments administered to treat mental illnesses in our not so distant past.1° civil commitment statutes of the mid twentieth century, the "danger-to-oneself-or­ another or gravely disabled" ("danger-or-grave-disability") statutes responded to the horrors of these treatments.'' additionally, a national shift toward outpa­ tient rather than inpatient treatment took place. 12 variations of the danger-orafter world war ii, 8 history of psychol. 176, 177, 183-84 (2005) (describing lobotomies in particular). one of the first american psychiatric asylums took up the practice of charging ad­ mission fees to the increasing number of curious sightseers who wished to view, and often har­ ass, the insane patients. e.g., joanmarie llania davoli, no room at the inn: how the federal medicaid program created inequities in psychiatric hospital access for the indigent mentally ill, 29 am.j. l. &med. 159, 167 (2003) ("at first, people came to view the mentally ill without official sanction. 'it was customary ... for idlers and thrill-seekers to gather about the cell win­ dows of the insane ... and to take turns at "teasing the crazy people," with the aim of rousing them into raving fury.' as an attempt to dissuade the locals from coming to view the mentally ill, the hospital officials began to charge a fee for admission.") (quoting albert deutsch, the mentally ill in amerjca 63-64 ( 193 7)) (describing the pennsylvania hospital, which opened in 1756). ironically, the word "asylum" originally was defined as a place of"shelter or protec­ tion from danger." the concise oxford english dictionary online (catherine soanes & angus stevenson, 1 ith ed. 2006). 10 jennifer gutterman, note, waging a war on drugs: administering a lethal dose to kendra's law, 68 fordham l. rev. 2401, 2405 (2000); starks & braslow, supra note 9, at 183-84. at the time, however, lobotomies were seen as revolutionary tools to help control men­ tal patients in hospital settings; in 1949 egas moniz, the first doctor to direct a modern lobot­ omy for psychiatric purposes, was awarded the nobel prize in physiology and medicine. starks & braslow, supra note 9, at 184-85. but see kitty dukakis & larry tye, shock: the healing power of electroconvulsive therapy passim (2006) (discussing the therapeutic value and importance of electroconvulsive therapy in modem psychiatry). 11 see, e.g., laura e. hortas, note, asylum protection for the mentally disabled: how the evolution of rights for the mentally ill in the us created a "social group,'' 20 conn. j. int'll. 155, 164 (2004)(noting that during the 1960s and 1970s a higher standard for substan­ tive commitment criteria was established). homosexuality provides a concrete illustration of some of the horrors that can arise in a legal system that is too deferential to medical doctrines. in early versions of the american psychiatric association's diagnostic and statistical manual ("dsm"), homosexuality was de­ fined and listed as a mental illness. see, e.g., william n. eskridge, jr., dynamic statutory interpretation 53-54 & 347 n.20 (1994). homosexuality is no longer considered a mental illness among medical professionals and according to the dsm. i d. at 53-54. such an example shows that permitting civil commitment based on a strict medical model could erode rights of individuals due to medical error or inaccurate scientific theories. c/ id. ideally, a balance be­ tween accurate medical and legal advances may create the most efficient and effective civil commitment laws. the danger-or-grave-disability statutes were not only responding to inaccurate medi­ cal doctrines but also to the horrors of judicial opinions that, for instance, sanctioned the sterili­ zation of the mentally ill in the early twentieth century. buck v. bell, 274 u.s. 200, 207 (1927) (holmes, j.) ("three generations of imbeciles are enough .... it is better for all the world, if instead of waiting to execute degenerate offspring for [a] crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind.") (up­ holding sterilization of the mentally disabled in a psychiatric hospital). 12 several revolutionary changes in the medical, scientific, and political fields (directly 2007] toward a twenty-first century civil commitment statute 365 grave-disability statutes are currently the law in all fifty states and serve to set a constitutional floor for state inpatient and outpatient civil commitment stat­ utes.13 related to mental health care) facilitated this major ideological shift. first, in the mid-1950s, the invention of antipsychotic drugs offered a far less invasive way to treat the severely and persis­ tently mentally ill. chlorpromazine (also known as thorazine or largactil) was the first antip­ sychotic drug, and it was put on the market in the mid-1950s. see, e.g., e. fuller torrey, surviving scmzophr.enia: amanualforfamiues, consumers, and providers 197 (5th ed. 2006) (1983) [hereinafter torrey, surviving scmzophrenia]. see also nancy k. rhoden, the limits of liberty: deinstitutionalization, homelessness, and libertarian theory, 31 emory l.j. 375, 379 (1982) (citing andrew t. scull, decarceration: community'frealment and 1he deviant: a radical vmw 80 (1977)). second, the civil rights movement brought about a political era in which individual civil liberties of the severely mentally ill were heavily guarded by grassroots organizations and legislatures and care:fully scrutinized by courts. hortas, supra note 11, at 156, 162 & n.68. third, the enactment of medicare and medicaid in 1965 statutorily excluded federal health insurance coverage for inpatient hospitalization, in part, due to the appeared magic bullet effect of antipsychotic drugs. see, e.g., davoli, supra note 9, at 170 (" 'except for those over sixty-five, the federal government would only provide benefits to persons not in state hospitals. to shift the financial burden to the federal government, states had to send patients into the community [for mental health treatment].'") (quoting rael jean isaac & virginia c. armat, madness in 1he streets 102 (1990)). cf. john d. morris, president signs medicare bill; praises truman, n.y. times, july 31, 1965, at ai, c8 (publicizing the expansion of health insurance for americans age sixty-five and older while simultaneously minimizing any discus­ sion of insurance for disabled persons). by the end of the twentieth century, medicaid's mental health inpatient exclusionary provision would prove to be a substantial roadblock to the effec­ tive treatment of the severely mentally ill in the states. "medicaid's exclusion of the majority of adults in psychiatric hospitals from its reimbursement program created a major incentive for states to simply vastly reduce the number of institutionalized patients, and to close hospitals altogether [in turn, releasing such patients to the streets]." davoli, supra note 9, at 169. what has been termed as the "deinstitutionalization" of the mentally ill, or in other words the sudden movement of the mentally ill from inpatient hospitals to alleged community treatment programs, may have been significantly caused by the medicaid inpatient exclusion. see. e.g., id. at 169-70. deinstitutionalization may appear to have a positive connotation at first, but it has proven to have serious tangential and unintended effects on the administration mental health treatment in america, including criminalizing and marginalizing the mentally ill over the last several decades. some scholars even refer to the deinstitutionalization movement as "transinsti­ tutionalization" because it failed to de-institutionalize the mentally ill but instead transferred them to the prisons, yet another type of"institution." see rhoden, supra note 12, at 391; davoli, supra note 9, at 169-70. in hindsight, the medicaid exclusion was probably most accu­ rately a premature overreaction to the advent of antipsychotic drugs, and when coupled with the danger-or-grave-disability statutes, in many ways resulted in a social-reform-based suicide. 13 see trea1ment aovoc. ctr., state standards for assisted trea1ment: state by state chart passim (2007), available at http://www.psychlaws.org/legalresources/­ documents/statestandards-thechart _ ooo.pdf (detailing the key language of each state's civil commitment statute; language concerning dangerousness or risk ofharm or injury is present in each). united states supreme court decisions sanctioned the danger-or-grave-disability legisla­ tive reforms by switching from a medical model (focusing on the presence of a mental illness) to a legal one (focusing on criteria such as dangerousness). o'connor v. donaldson, 422 u.s. 563,515 (1975)("a finding of mental illness alonecannotjustify[commitment] •.• [the indi­ vidual must also be dangerous]."); see also hortas, supra note 11, at 164. this change reflected 366 indiana health law review [vol. 4:361 the danger .:.or-grave-disability statutes typically require by the demanding standard of "clear and convincing evidence''14 a showing of either an immi­ nene5 or a substantial risk of 16 1) danger to oneself or another or 2) grave dis­ ability.17 the danger-or-grave-disability statutes have proven to have serious the supreme court's belief that a medical diagnosis of''mental illness" alone was not enough to deprive an individual of his or her legal right to liberty. 0 'connor, 422 u.s. at 575. 14 findings by "clear and convincing" evidence are the constitutional minimum for civil commitment statutes. addington v. texas. 441 u.s. 418,433 (1979). therefore, some states have enacted the higher standard of"beyond a reasonable doubt." see id clear and convincing evidence is more than a ''preponderance of the evidence" typically required in civil cases but less than "beyond a reasonable doubt" required in criminal cases. 15 a few examples of state immanency standards that gauge dangerousness in civil com­ mitment statutes are as follows: 1) "real and present threat of substantial harm," ala. code § 22-52-1 0.4( a) (lexisnexis 1975 & supp. 2006) (applied only to inpatient treatment); 2) "clear and present danger," ark. code ann.§ 20-47-207(c) (2001 & supp. 2005); and 3) "demon­ strated danger of inflicting substantial physical harm upon others," lanterman-petris-short act, cal. welf. & inst. code § 5300(a) (west 1998). an analogy to imminence of harm standards in ftee speech statutes might be made here. subversive advocacy speech, or speech potentially directed to incite illegal activity, for example, is often adjudicated on a demanding "clear and present danger'' standard. schenck v. united states, 249 u.s. 47, 50 (1919) (holmes, j.); brandenburg v. ohio, 395 u.s. 444, 447 (1969) (per curiam) (substituting an "imminence" test for what was previously referred to as the "clear and present danger" test). yet in some states, such as arkansas, this same "clear and present danger'' standard is being applied to assess whether severely mentally ill individuals are in need of life enabling medical treatment. ark. code ann. § 20-47-207 (200 i & supp. 2005). one approach is that we should be very reluctant to restrict mere speech and therefore the demanding standard is much needed, but that in the cases of severely mentally ill persons who seem likely to be at a risk of danger to themselves or others, the same demanding standard protects a very doubtful patient autonomy at an unnecessary risk to safety. cf. e.g., abrams v. united states, 250 u.s. 616, 628, 630 (1919) (holmes, j., dissenting) ("it is only the present danger of immediate evil or an intent to bring it about that wammts congress in setting a limit to the expression of opinion where private rights are not concerned."). the higher evidentiary burden of proof in criminal ftee speech cases may account for this difference in values to some extent. in criminal ftee speech cases, the burden of proof is beyond a reasonable doubt, whereas in civil commitment cases the burden of proof is by clear and convincing evidence. therefore the burden of proving "clear and present danger'' is reduced in civil commitment cases. none­ theless. one is still left to wonder why such similar legal standards are used in two highly differ­ ent situations. 16 ind. code ann. § 12-7-2-53 (l.exisnexis 2006) (''dangerousness" in the civil com­ mitment statute is defined as "a condition in which an individual as a result of mental illness, presents a substantial risk that the individual will harm the individual or others."). see also mass. gen. laws ann. ch. 123. § 1 (west 2003) ("likelihood of serious harm" is defined in three ways, one ofwhich,js "a substantial risk of physical harm to other persons as manifested by evidence ofhomicidal or other violent behavior or evidence that others are placed in reason­ able fear of violent behavior and serious physical harm to them ... .''). 17 in california's lanterman-petris-short act. "gravely disabled" is defined as "a condi­ tion in which a person. as a result of a mental disorder, is unable to provide for his or her basic personal needs for food, clothing, or shelter." cal. welf. & inst. code§ 5004.5(h){l){a) (west 1998). although the various texts of the danger-or-grave-disability statutes linguistically vary from state to state (as do their judicial interpretations). the gravely disabled standard is generally extremely difficult to establish in the case of a severely mentally ill individual. 2007] toward a twenty-first century civil commitment statute 367 problems in their execution.18 critically, the extraordinarily high level of proof these laws require has proven problematic in protecting both the safety of the public19 and the safety (and health) of mentally ill persons themselves. for many severely mentally ill persons, this standard is nearly impossible to prove in a court oflaw and resultantly fails to protect a significant population of severely mentally ill persons: those who are in need of treatment but are nei­ ther dangerous nor disabled to the extreme degree. the virginia tech massacre highlights this failure. in this mental health tragedy, a young college student presented a host of symptoms of a developing severe mental illness, which was reported by roommates and professors to authorities, but the mentally ill indi­ vidual failed to receive any type of meaningful or lasting outpatient psychiatric treatment due to the high evidentiary requirement that he be an "imminent" danger to himself or others. 20 further, the danger-or-grave-disability statutes do not seek to prevent the deterioration of a severe mental illness. rather, they wait for moments of ex­ treme deterioration to occur before permitting involuntary treatment, by which time it may be too late to effectively rehabilitate the individual. from a medical and social welfare standpoint, it might be said that the danger-or-grave­ disability statutes discriminate against the class of severely mentally ill persons whose mental illnesses are severe but manifest in less classically violent or debilitating ways. · pvot statutes may be to the twenty-first century what the danger-or­ grave-disability statutes were to the twentieth century. just as the danger-or­ grave-disability statutes responded to a cry against horrors of mental health care for instance, in indiana, which defines gravely disabled in much the same way as california, see ind. cone ann. § 12-7-2-96, "grave disability" was not established in a case in which a twenty-four-year-old diagnosed with schizophrenia was suffering from auditory halluci­ nations and perceived his roommates speaking to him through his computer speakers. in re steinberg, 2004 ind. app. lexis 2673, at *9 (2004). the court found that the individual was capable of maintaining an apartment with a roommate in a college town and there was no evi­ dence that he was unable to provide for his "essential human needs" pursuant to the language of the statute. id. at *io(citingind.codeann. § 12-7-2-96). additionally, thistwenty-fouryear old also failed to meet the substantial risk of imminent harm standard under the danger prong of the danger-or-grave-disability statute, even though he had been arrested several times and had pointed a gun at individuals in a college setting. /d. at *8. therefore no involuntary treatment was ordered even though there were clear signs he was developing schizophrenia and also came from a family that had a history of the disease. /d. at *7, *10-ll. 18 for a compelling argument that all persons who are dangerous should be civilly com­ mitted, rather than only dangerous mentally ill persons, see elyn r. saks, refusing care: forced treatment and the rlgfits of the mentally ill 50-51 (2002) [hereinafter saks, refusing care). 19 new york's pvot statute, kendra's law, for example, was enacted after a middle­ aged male diagnosed with paranoid schizophrenia who had sought treatment previously but failed to meet the danger requirements, pushed an innocent bystander into a moving subway, causing her death. see kendra's law, n.y. mentalhyg. law§ 9.60 (mckinney 2006); fritz, supra note 8. at al2. see also infra part v.a. 20 see, e.g., torrey, commitment phobia. supra note 3. 368 indiana health law review [vol. 4:361 treatment that needed increased legal protection, pvot statutes are responding to a cry against horrors of weak mental health care laws that need increased medical protection. pvot statutes aim toward a more medically-based eviden­ tiary approach compared to the danger-or-grave-disability statutes. this in­ cludes medical criteria such as severity and history of the mental illness in conjunction with stricter legal criteria, such as the traditional "dangerousness" standard. at the same time there remains a lurking caution and focus on indi­ vidual liberties through hefty factor-based-safeguards to ensure that the core liberties and dignities of the severely mentally ill are still respected. additionally, pvot statutes are a branch of outpatient commitment stat­ utes ("ot") because of their focus on treatment in the community rather than in a psychiatric hospital twenty-four hours a day.21 ot statutes have been work­ ing in tandem with the danger-or-grave-disability statutes for several decades. recent scholars, however, have been referring toot more specifically as "as­ sisted outpatient treatment" ("aot") statutes?2 the purpose of the addition of the word "assisted" tends to emphasize that such individuals need more genuine assistance from the community in order to effectively adhere to their ot plans.23 the traditional fears of institutionalization are somewhat of a fiction with respect to ot, aot, and pvot statutes. this is because the "commitment" is more figurative because the state seeks to ensure that the patient remains "committed" to the treatment plan likely to be the most beneficial rather than "committed" to a hospital.24 though the term "civil commitment'' sounds 21 forty-two of the danger-or-grave-disability statutes have an aot component. treatment advoc. ctr., assisted outpatient treatment 1 (2005), available at http://­ www.psychlaws.org/briefingpapers!bp4.pdf. 22 treatment advoc. ctr., modellawforassisted1'reatment,supranote6§2.1.2 (defining "assisted treatment" and "assisted outpatient treatment"). 23 telephone interview with ron honberg, director of policy & legal affairs, national alliance on mental illness, in indianapolis, ind., apr. 2007 (stating that the treatment advo­ cacy center coined the term). 24 an involuntary aot plan does not require that the individual be an inpatient of a twenty-four hour psychiatric hospital or a resident of a halfway house. ken kress, an argument for assisted outpatient treatment for persons with serious mental illness illustrated with r4erence to a proposed statute for iowa, 85 iowa l. rev. 1269, 1291 (2000). instead, an aot plan is court-mandated psychiatric treatment that often includes taking medication "as a condition of remaining in the community." treatment advoc. ctr., assisted outpatient 1'reatment,supranote21, at 1. a typical ... [ aot] plan involves visiting a psychiatrist or mental health profes­ sional at regular intervals (generally every four to eight weeks), taking prescribed medications, and occasionally undergoing psychotherapy .... [sometimes], it in­ volves case management, rehabilitation, assistance in obtaining housing, and, if appropriate, assistance in obtaining employment. kress, supra note 24, at 1291. violation of court-ordered aot conditions typically results in the individual being hospitalized for further psychiatric treatment. treatment advoc. ctr., assisted 0utp atient treatment, supra note 21, at 1. in sum, aot statutes require the patient 2007] toward a twenty-first century civil commitment statute 369 somewhat archaic and invasive, and forced medication is still invasive in many respects, outpatient commitment is an improvement for mental health care be­ cause more liberty is likely to be preserved outside of the hospital setting. 25 overall, aot statutes represent a movement toward outpatient treatment and away from inpatient treatment, with an increasing reliance on medication. there are currently three types of aot statutes, one of which includes pvot?6 first is the preventive or early intervention aot?7 this type of aot includes pvot, as well as the danger-or-grave disability statutes (though to a more distant degree of prevention), and other types of preventive treatment such as criminal diversion programs, which are often administered through local mental health courts.28 second is psychiatric-hospital diversion aot.29 this type of statute permits individuals who are already civilly committed to avoid inpatient hospitalization and instead obtain treatment in the community.30 third is conditional discharge aot. 31 this type of statute permits forced out­ patient treatment for individuals who are discharged from a psychiatric hospital with a continued treatment plan that they must continue to follow. 32 this note focuses on the first type of aot statute described above: pre­ vention and early intervention. only a limited number of states have enacted the type of pvot statute that this note addresses.33 while forty-two states have enacted general aot statutes, these statutes include all three types of aot and can be very different in nature.34 an important side note to this discussion is that due to the variation of the three major categories of aot statutes, and because mental health legislation varies from state-to-state (and even county-to-county), different terms and ab­ breviations are being used interchangeably and possibly incorrectly in academic and medical discourse on the topic. for clarification purposes, and to ensure future discussions on the topic are accurate, the existing set of terms should be to follow a prescribed treatment plan while permitting the individual to continue to live at a residence of his or her choice. see, e.g., kress, supra note 24, at 1291. 25 contra saks, refusing care, supra note 18, at 87 ("[w]hereas hospitalization in­ volves greater restrictions on one's [physical] liberty than does medication, the latter in a sense involves greater intrusion into one's person. it changes one's mental state--one's very thought processes-and in a way that can't be resisted by any effort."). 26 e.g., honig & stefan, supra note 3, at 110. see also kress, supra note 24, at 1291. 27 honig & stefan, supra note 3, at 110; kress, supra note 24, at 1291. 28 see honig & stefan, supra note 3, at 110; kress, supra note 24, at 1291. see infra part x.a (discussing mental health courts). 29 honig & stefan, supra note 3, at 110; see kress, supra note 24, at 1291. 30 honig & stefan, supra note 3, at 110; see kress, supra note 24, at 1291. 31 honig & stefan, supra note 3, at 110; kress, supra note 24, at 1291. 32 honig & stefan, supra note 3, at 110; kress, supra note 24, at 1291. 33 see infra part vi (describing the pvot statutes offlorida and michigan, as well as at least three other states considering adopting pvot). see supra note 3 (describing the pvot statutes ofnorth carolina and hawaii). 34 see, e.g., honig & stefan, supra note 3, at 110 & n.s (citing a treatment advoc. ctr. paper); kress, supra note 24, at 1291. see also treatment advoc. ctr.., assisted outpatient 1'rea1ment, supra note 21, at 1. 370 indiana health law review [vol. 4:361 consolidated or a new set should be devised in order to begin effectively distin­ guishing among the three types of aot. currently, medical and legal articles use terms such as "aot,"35 "ot"36 (outpatient treatment), "pct" (preventive commitment statutes), "poc" (preventive outpatient commitment),37 "cot" (community outpatient treatment), "ioc"38 (involuntary outpatient commit­ ment), "opc"39 (outpatient commitment), and "pact" (preventive assisted community treatment), often, to refer to the same types of treatment the prob­ lem-that these terms may have radically different meanings depending on the jurisdiction and context from which they arise-is somewhat of a microcosm for the broader problem that mental health care is often a local creature with few national (or sometimes even state-wide) enforcement mechanisms. none­ theless, this note uses the abbreviation pvot to refer to the most recent subset of aot statutes: those that do not require "dangerousness" (though may use it as an aspect) and permit evidence concerning the broader history of the mental illness to be taken into consideration for civil commitment pvot statutes may be distinguished from traditional aot or ot statutes even though each focuses on administering outpatient treatment under a civil commitment statute.40 the goal ofpvot is to use the latest advances in psy­ chopharmacological drugs in conjunction with a variety of therapies and voca­ tional counseling to foster the rehabilitation of the severely mentally ill through regular, monitored, and lengthier outpatient psychiatric treatment41 treatment plans under pvot last for at least six months and involve a broader system of support between the pvot recipient and a wide array of counselors including therapists, social workers, vocational workers, and psychiatrists.42 treatment plans are also individually tailored to each individual, which makes it more likely that a patient will adhere to his or her outpatient treatment plan. 43 35 honig & stefan, supra note 3, at 110. 36 cf kress, supra note 24, at 1291 (proposing an assisted outpatient treatment statute with some aspects of conditional release yet referring to it as "outpatient treatment'') ("hence­ forward, when i deploy the phrase 'outpatient treatment' in this article to refer to the proposed statute, i refer to preventive treatment, unless the context otherwise makes clear."). 37 cornwell & deeney, supra note 3, at 209 & n.3 (''for the purpose of uniformity, we will use the term preventive outpatient commitment or poc throughout the article, recognizing that some jurisdictions prefer different terminology. for example, in new york, poc is referred to as assisted outpatient treatment or aot.''). 38 honig & stefan, supra note 3, at 110 (''opc, also called preventive commitment, assisted outpatient treatment(' aot'), or involuntary outpatient commitment ('ioc') .... "). 39 honig & stefan, supra note 3, at 109-10. 40 pvot statutes, synonymous with "model law'' used by the treatment advocacy cen­ ter, were in a sense created by the treatment advocacy center through the "compilation of the most effective provisions of existing state laws." jonathan stanley, important aspects of the mode/law,inl'reatmentadvoc.ctr.,modellawforassisted'freatment,supranote6. 41 see e. fuller torrey & mary t. zdanowicz, introduction to treatment advoc. ctr., model law for assisted treatment, supra note 6. 42 see infra part v. 43 id. 2007] toward a twenty-first century civll commitment statute 371 recent reports show that pvot statutes are having quantifiable positive effects in those states that have implemented them.44 rates ofhomelessness, recidivism, incidences of harmful behaviors, and victimization of the severely mental ill are reported to have dropped significantly in the key pvot state, new york.45 additionally, pvot statutes have reportedly improved both ac­ cess to and effectiveness of mental health care for the severely mentally ill.46 this data suggest that states should build upon or implement pvot to improve state mental health care systems. iii. recent scientific and medical advancements concerning severe and persistent mental illness in order to consider any type oflegal change that affects the severely men­ tally ill, it is important to identify the current medical and scientific understand­ ing of the nature and development of severe mental illnesses. a. what constitutes a severe and persistent mental illness? the dsm-~7 does not define "severe and persistent mental illness.'.48 yet many mental health organizations, such as the treatment advocacy center and the national alliance on mental illness ("nami"), use the phrase to iden­ tify a certain group of mentally ill persons.49 typically, "severely and persis­ tently mentally ill" individuals are those who suffer from a dsm-iv axis i 44 see infra part viii (discussing statistical results of the 2005 new york final report on kendra's law). 45 /d. 46 !d. 47 the fourth edition of the diagnostic and statistical manual of mental disorders is currently used by psychiatrists, physicians, and psychologists to diagnose mental illnesses. see am.psycidatricass'n,qtnckreferencetothediagnosticcriteriafromdsm-n-tr® xi (9th ed. 2005) [hereinafter am. psychiatricass'n, dsm-iv-tr]. 48 therefore medical professionals have been using it to make distinctions about a specific group of mentally ill individuals, those who are most in need of help. the broad area of severe [and persistent] mental illness has suffered, in our view, from the lack of a clear working definition and it is time that one was agreed among those working in the field. this is necessary at a national level for assess­ ing overall needs and resources and at local level for responding sensitively but explicitly to those persons most in need of help. andrew barker & alain gregoire, defining severe mental illness, in adult severe mental illness i (alain gregoire ed., 2000) (quoting mental health found. 1994)(discussing some of the definitions proposed since the 1980s) (emphasis added). 49 e.g., joe v anable, president, naml indiana, panel address at norman amaker public interest law and social justice retreat: seeking justice for people with mental illness (feb. 24, 2007) (power point presentation on file with author). see generally treatment advoc. ctr., http://www.psychlaws.org (last visited mar. 9, 2006). 372 indiana health law review [vol. 4:361 disorder. 50 this includes schizophrenia, schizoaffective disorder, bipolar disor­ der, and major depression. 51 symptoms of axis i disorders may have three separate dimensions: i) positive symptoms, 2) negative symptoms, and 3) cognitive symptoms. 52 posi­ tive symptoms include symptoms that did not exist before the development of the mental illness and are therefore new and more concrete. 53 they include symptoms of hallucinations, paranoia, and delusions and are often associated with reality distortion. 54 negative symptoms include emotions that the individ­ ual may have experienced before the mental illness, such as sadness or anger, but now exhibits on a more regular basis. 55 these symptoms are typically asso­ ciated with a decline in emotional functioning, including social withdrawal or the inability to experience pleasure.56 finally, cognitive symptoms include those symptoms that affect memory and attention. 57 because numerous axis i disorders may include symptoms that are posi­ tive, negative, and cognitive, those suffering from schizophrenia, contrary to popular belief, are not the only class of severely mentally ill persons who might suffer from reality-distorting hallucinations and delusions. those who suffer from bipolar disorder or major depression may also experience equally debili­ tating hallucinations or delusions. 58 hence, it is no longer accurate to think of 50 axis i disorders do not include personality disorders, mental retardation, or psychoso­ cial and environmental problems. am. psycidatric ass'n, dsm-iv-tr,supra note 47, at 37. physicians making a clinical diagnosis of an axis i disorder also indicate the severity of the illness by specifying it as one of the following: "mild, moderate, severe, in partial remission, in full remission, and prior history." see id. at 2. "severe" is defined as "[m]any symptoms in excess of those required to make the diagnosis, or several symptoms that are particularly se­ vere, are present, or the symptoms result in marked impairment in social or occupational func­ tioning." ld. at 3. 51 see id. at 37-38. 52 l.m. camargo et al., disrupted in schizophrenia 1 lnteractome: evidence for the close connectivity of risk genes and a potential synaptic basis for schizophrenia, 12 molecular psychiatry 74, 74 (2007) (focusing on schizophrenia); nami family-to-family education program, symptoms leading to a diagnosis of depression and mania, at 2.25 (on file with author). 53 see nami family-to-family education program, symptoms leading to a diagnosis of schizophrenia, at 2.20 (on file with author). 54 e.g., camargo et al., supra note 52, at 74; colm m.p. o'tuathaigh et al., susceptibil­ ity genes for schizophrenia: characterisation of mutant mouse models at the level ofpheo­ typic behavior, 31 neuroscience & biobeha vloral revs. 60, 61 (2007). 55 see nami family-to-family education program, symptoms leading to a diagnosis of schizophrenia, at 2.20 (on file with author). 56 e.g., camargo et al., supra note 52, at 74; see o'tuathaigh et al., supra note 54, at 61. 57 see, e.g., camargo et al., supra note 52, at 74; o'tuathaigh et al., supra note 54, at 61; see also christopher m. wilk et al., no, it is not possible to be schizophrenic yet neurop­ scyhologically normal, 19 neuropsychology 778, 778 (2005) (confirming that a core feature of schizophrenia is neuropsychological impairment). 58 ted coburn, in our own voice, nami-indiana, opening speaker at the 4th annual mental health & criminal justice summit, indianapolis (mar. 23, 2007) (describing his per2007] toward a twenty-firstcenturycivilcommitmentstatute 373 major depression or bipolar disorder as immune from symptoms traditionally associated with the more classic severe mental illness, schizophrenia. 59 b. genetics and the environment research has shown that both genetics and the environment play an im­ portant role in the development of severe mental illnesses. genetic studies of schizophrenia suggest that the disease is caused by abnormal brain synapses.60 while no single gene has as yet been pin-pointed as the primary cause, several medical studies offer strong evidence that one or two particular genes may be closely connected with the malfunctioned synapse.61 similarly, some medical researchers suspect that the cause of schizophrenia may be the result of a com­ plex interaction of multiple genes, rather than any single gene. 62 the multiple gene theory often incorporates the influence of environmental factors. studying the environment alongside genetics has been important to re­ searchers because of the weaknesses in strict genetic theories. 63 for instance, among identical twins there is estimated to be only a fifty percent chance of developing schizophrenia.64 additionally, among fraternal twins and siblings, both of whom on average share the same percentage of parental genes, the risk of developing schizophrenia is only between nine and twenty-seven percent.65 finally, from first-degree to second-degree relatives there is a considerable fall­ off in the risk of developing schizophrenia. 66 these studies suggest that while a sonal experiences with delusions and bipolar disorder). see also richard rende et al., psychotic symptoms in pediatric bipolar disorder and family history of psychiatric illness, 96 j. affective disorders 127, 127 (focusing a medical study on the relation between psychotic symptoms of pediatric bipolar patients and family history of severe mental illnesses, such as schizophrenia). 59 am. psychiatric ass'n, dsm-iv-tr, supra note 4 7, at 198-99 (describing criteria for a severe major depressive episode with psychotic features or a severe manic episode with psychotic features). 6° camargo et al., supra note 52, at 74. brain images of those diagnosed with schizo­ phrenia suggest that the "reduced synaptic connectivity may result from improper neurodevel­ opment culminating from an underlying genetic predisposition .... " id 61 see camargo et al., supra note 52, at 75. 62 e.g., lynn e. delisi & wolfgang fleischhaker, &hizophreniaresearch in the era of the genome, 2007, 20 current opinion in psychiatry 109, 110 (2007). 63 one study, which focused on whole-genome association technology to study schizo­ phrenia, supports ''the presence of cytokine receptor abnormalities in schizophrenia . . . [, which] may help explain prior epidemiologic data relating to the risk for this illness to altered rates of autoimmune disorders, prenatal infection and family leukemia." t. lencz et al., con­ verging evidence for a pseudoautosomal cytokine receptor gene locus in schizophrenia, 12 molecular psychiatry 572, 572 (2007). 64 e.g., lencz et al., supra note 63, at 578. see also robin mccreadie, schizophrenia, in adult severe mental illness 12 (alain gregoire ed., 2000) (estimating that the concor­ dance rate for schizophrenia in monozygotic twins is between thirty-five and fifty-eight percent); delisi & fleischhaker, supra note 62, at 110; see, e.g., o'tuathaigh et al., supra note 54, at 61. 65 mccreadie, supra note 64, at 12; delisi & fleischhaker, supra note 62, at 110. 66 delisi & fleischhaker, supra note 62, at 110. 374 indiana heal til law review [vol. 4:361 genetic predisposition is certainly present for a disease like schizophrenia, it is arguably not the only-or even the controlling-factor.67 for some individuals, traumatic events may trigger the genetic predisposi­ tion to develop the illness. 68 other medical research studies have suggested a link between cannabis use and the development of severe mental disorders with psychotic symptoms. 69 and still others show that .. [ w ]ell-replicated findings of increased ... risk [of schizophrenia] for winter-born and urban-born individu­ als, combined with large-scale studies demonstrating increased risk following maternal exposure to a variety of infectious pathogens, have suggested that pre­ natal infection may represent a significant environmental risk factor."70 addi­ tionally, a theory concerning a human virus transmitted by a parasite typically carried by cats has been proposed as an environmental factor that may influence a genetic susceptibility to schizophrenia. 71 research still needs to be conducted concerning the genetic and environ­ mental interplay at work in the development and nature of severe mental illness. in the near future, with rapid scientific and technological advances, more con61 some genetic studies also show that a particular gene may influence the susceptibility of developing multiple axis i disorders. such as bipolar disorder and schizophrenia. e.g., g. v azza et al., genome-wide scan supports the existence of a susceptibility locus for schizo­ phrenia and bipolar disorder on chromosome 15q26, 12 molecular psychiatry 87, 87 (2007); p a. thomson et al., association ofneuregulin 1 with schizophrenia and bipolar dis­ order in a second cohort from the scottish population, 12 molecular psycidatry 94, 94, 100, 103 (2007); contra rende et al., supra note 58, at 130 (noting a lack of association be­ tween psychosis in bipolar disorder and a family history of schizophrenia but also emphasizing the limitations of the study as the possible cause for the conclusion). under this genetic-based theory, researchers are less focused on the classification of the mental illness but more on the extent to which any severe mental illness continues to manifest itself in the gene-sharing family. some studies narrowing in on affective disorders, such as bipolar disorder and depression, have identified particular groups of chromosomes as potential genetic causes. david s. baldwin, ajfectivedisorders,inadultseverementalillness42(alaingregoireed.,2000). interest­ ingly, the genetic strength for developing bipolar disorder is stronger compared to both schizo­ phrenia and depression. see id. at 43 (stating that the concordance rate for bipolar among identical twins is roughly seventy percent). 68 for example, one individual reported that his bipolar disorder, accompanied by delu­ sions ofbeing "the one" in the matrix, when coupled with the tragic events and devastation he experienced on 9/11, led him to violent reaction when he believed terrorists were on board an aircraft with him on a commercial plane. ted coburn, in our own voice, nami-indiana, opening speaker at the 4th annual mental health & criminal justice summit (mar. 23, 2007). 69 e.g., don linszen & therese van amelsvoort, cannabis and psychosis: an update on course and biological plausible mechanisms, 20 current opinion in psycidatry 116, 118 (2007) ("there seems to be no doubt that cannabis can induce psychosis in a subgroup of people who already are susceptible for developing psychotic symptoms."); michael rutter, psycho­ pathological development across adolescence, 36 j. youth adolescence 101, 106 (2007) (discussing the potential beginning of severe mental illnesses such as schizophrenia in adoles­ cence). 70 e.g., lencz et al., supra note 63, at 578. 71 see torrey, surviving schizophrenia, supra note 12, at 143-44. 2007] toward a twenty-first century civh.. commitment statute 375 crete data concerning both the genetic and environmental influences will be­ come available. once we fully understand the nature of severe mental illness, how it is caused and how we can treat or possibly cure it, the laws surrounding . forced medication will undoubtedly change to reflect scientific advances. c. cognition and insight deficits in attention and memory are an important cognitive feature of se­ vere mental illnesses. research suggests that persons with schizophrenia, for example, are "meaningfully impaired in real-world tasks that involve shifting attention in cluttered scenes. tasks as mundane as scanning the tv listings for a preferred program or fmding the right variety of soup on a shelf may require significantly more time and effort .... "72 this type of attention impairment makes it extremely difficult for a person with a severe mental illness to keep up with the daily pace of any type of employment. 73 the level or lack of personal insight into a severe mental illness is critical to understanding why involuntary treatment is necessary to treat severe mental illnesses. research suggests that about half of patients with severe mental ill­ nesses lack the insight-awareness or understanding-that they suffer from mental illness. 74 the implications of this for the law are critical since involun­ tary or forced treatment is a focus of many civil commitment statutes. cer­ tainly, lack of insight means a lack of a requisite level of autonomy that is 72 rebecca l. fuller et al., impaired control ofvjsuolattention in schizophrenia, 115 j. abnormal psychol. 266, 273 (all patients in the study were taking medication). see also elyn r. saks, the center cannot hom: my journey through madness 229 (2007) [here­ inafter saks, the center cannot horn] (describing the chaotic feeling ofhaving one's atten­ tion pulled in hundreds of directions, which is often an aspect of schizophrenia). 73 torrey, surviving schizophrenia, supra note 12, at259 ("estimates of the number of persons with schizophrenia capable of full-time work range as low as 6 percent .... "). an interactive web site illustrates how a person suffering :from schizophrenia fiiced with the simple task of filling a prescription in a drug store may become confused and disoriented upon hearing voices and seeing haunting figures that may lead to irrational behaviors. the sights and sounds of schizophrenia (npr broadcast 2002), available at http://www.npr.orgltemplates/story/­ story.php?storyld=1149147. contra saks, the center cannot hold, supra note 72, at pas­ sim (describing how focusing on her work, and in her case, highly rigorous academic work, helped to keep her functioning in the world during critical periods of her struggle with schizo­ phrenia; simultaneously, it helped to preserve her core identity outside of mental illness, which became like a life vest that kept her :from sinking deeper into mental illness). 74 e.fullertorrey,ouroftheshaoows:confrontingamerica'smentaliilness crisis 154 (1997) [hereinafter torrey, our of the shadows]. in a study published by xavier amador and his colleges in new york, fifty-seven percent of persons with schizophrenia were unaware that they were psychiatrically impaired. id in a study published by anthony david and his colleges at london's institute for psychiatry, forty-seven percent of patients had im­ paired insight into their illnesses. ld see also xavier amador, i am not sick, i don'tneed help! 31-32 (2d ed. 2007) (describing how poor insight is a symptom of severe mental illness that is neurologically based). 376 indiana health law review [vol. 4:361 typically required to make a voluntary decision. 75 without autonomy, arguably, no truly free decision can be made. 76 studies have shown that the level of a severely mentally ill person's insight into his or her own illness is likely to vary based upon age, duration of the illness, and possibly the tendency toward the commission of violent acts. n · d. violence violent acts are typically the means by which the public hears about se75 see john sroartmill. on liberty (penguin books 1974) (1859) (referring to such persons through a broader reading ofhis language). ''mill himself found nothing inconsistent in applying libertarianism only to those lacking a mental disorder." john monahan, john stuart mill on the liberty of the mentally ill, a historical note, 134 am. j. psychiatry 1428, 1428 (1977) [hereinafter monahan, mill on the liberty of the mentally illj. mill's general theory on autonomy is that a government may justifiably restrict an individual's autonomy only when the individual's actions or behavior poses a danger to other persons in society. mill.supranote75,at68-69, 141-42,145,149. thistheoryhastypically been used to reinforce the policies of the danger-or-grave-disability statutes; thus, that these­ verely mentally ill should only be involuntarily treated when they are a danger to themselves or to others. e.g., monahan, mill on the liberty of the mentally ill, supra note 75, at 1428. there are several explicit exceptions, however, to mill's general theory on governmental paternalism that are sometimes overlooked. see id for instance, mill states that children, teenagers, per­ sons "in a state to require being taken care ofby others," and persons in a "backward state[] of society" are expressly excluded from the general rule that paternalistic action is justified only to prevent danger to others. mill. supra note 75, at 69. professor monahan points out that this exception may also be read as applying to those who lack "the maturity of their faculties" and are "in a state to require being taken care ofby others." monahan, mill on the liberty of the mentally ill, supra note 75, at 1428 (quoting mill. on liberty, supra note 75, at 69). there­ fore, the great libertarian himsel.t and his theory on the tension between govemmental paternal­ ism and individual autonomy, tend to create an exception that would permit involuntary treatment of the severely mentally ill even when they tail to pose a danger to others or to them­ selves. 76 see jayne breeze, can paternalism be justified in mental health care?, 28 j. advanced nursing 260, 262 (1998) (citingt. l. beauchamp&j. f. clm.drfss, pluncipulsof biomedical ennes (3d ed. 1989); gerald dworkin, paternalism, in phn.osophy of law (2d ed. 1980); r gunmil & p.s. appelbaum, cunical handbook of psychiatry and tile law (1982)) (discussing ''weak" or justified patemalism in the context of rational autonomy and how it can promote individual autonomy by restoring the missing element of rationality). 77 some scientists argue that insight into a developing severe mental illness is best in the early stages of the disease's development. under this theory, incremental damage to specific parts of the brain leads to decreased awareness overtime. torrey, surviving schizophrenia, supra note 12, at 51. therefore, a person who is older and has had a severe mental illness for a longer period of time is more likely to suffer from greater lack of insight and will be less likely to seek voluntary treatment. see id other scientists argue, however, that individuals who lack the greatest insight into their severe mental illnesses are those more prone to violence: particu­ larly, those who were arrested or committed a violent act in the previous year. eric b. elbogen et al., the impact of perceived need for treatment on risk of am!st and violence among peo­ ple with severe mental hlness, 34 clum. just. & behav. 197, 206 (2007). 2007] toward a twenty-fmstcen'rurycivilcommitmentstatute 377 verely mentally ill persons. the media attention surrounding the virginia tech massacre illustrates this phenomenon.78 but contrary to popular belief, many scientific studies have struggled to find a concrete link between violence and severe mental illness.79 the results of these studies range depending upon any of the following variables: the target diagnosis of the study;80 the particular symptoms reported (rather than diagnosis itself);81 the type of crime committed or studied;82 neurological data of the illness; geographic location of the study;83 prior hospitalizations; previous criminal conduct of the individual; the living 78 letters to the editor, virginia tech shootings; media attention encourages next attack, detroit free press, apr. 23, 2007, at 14a. 79 see infra notes 80-95. 80 for example, researchers might study incidences of violence among schizophrenics, manic-depressives, or those suffering from major depression. one prominent study showed that persons with schizophrenia had lower rates of violence compared to those with bipolar disorder and depression. john monahan et al., rethinking risk assessment: the ma.car.tiiur stijdy of mental disorder and violence 64 (2001) [hereinafter monahan et al., ma.car.tiiur sruny]. after one year, those with bipolar and depression had a violence inci­ dence rate of22% and 28.5% (respectively), compared to those with schizophrenia who had a reduced rate of 14.8%. ld.; but see torrey, out of the shadows, supra, at 74 (citing a 1994 english study that found a higher risk of violence among schizophrenic patients compared to controls with other psychiatric diagnoses); patricia a. brennan & amanda alden, schizophre­ nia and violence: the overlap, in crime and scmzophrenia: causes and cures 25-26 (adrian raine ed., 2006) ("the weight of the evidence suggests a significant and large effect of schizophrenia on risk for violence."). 81 . some studies suggest that the level or degree of a particular symptom may be the best predictor of violent behaviors rather than sheer clinical diagnosis. skeem et al., psychiatric symptoms and community violence among high-risk patients: a test of the relationship at the weekly level, 74 j. consulting & cunical psychol. 967, 968 (2006)( citing prior stud­ ies). a recent study challenged this hypothesis and found that average levels ofhostility, rather than general distress or other symptoms (such as depression, anxiety, and thought control), of high risk patients discharged ftom inpatient hospitals (emergency rooms) was the best indicator of violence over a six month period. ld at 972, 974 (patients were monitored on a weekly ba­ sis). hostility was measured as "feeling easily annoyed or irritated; temper outbursts that he or she could not control; having urges to beat, injure, or harm someone; having urges to smash things; and getting into frequent arguments." ld at 973. hence, deterioration in symptoms of depression, anxiety, or thought-control (often related with schizophrenia) did not correlate with an increased risk in violence in the short term. particularly on an arguably "imminent" weekly basis. see id at 976. the skeem et al. study suggests that in order to reduce violence among the severely mentally ill, resources should be channeled to improve anger management andre­ duction. jd. at 977. 82 for example, some researchers have studied the incidence ofsubway-pushings, which apparently seems to be a crime related primarily to those with mental illness. torrey, out of the shadows, supra note 74, at 46-47. 83 one national study in the united states estimated that in 1992 persons with mental illness were responsible for 770 out of23,000 homicides in the united states (roughly 3.3%). torrey, out of the shadows, supra note 74, at 49 (noting that in iceland, a country with an extremely low homicide rate, twenty-eight percent of its homicides were committed by mentally ill persons over an eighty year period). 378 indiana health law review [vol. 4:361 environment of the mentally ill individual;84 and whether or not there is a diag­ nosis of a co-occurring substance abuse disorder.85 some studies have shown that an increased level of psychotic symptoms may be the best predictor of the likelihood of committing a violent act. 86 other studies suggest that one important predictor of future violence among the se­ verely mentally ill is non-adherence to medication. 87 there is also evidence that a failure to provide effective treatment on an outpatient basis is another contributing factor to the incidence of violence with severe mental illness. 88 one of the most prominent studies in the field, the macarthur study, sug­ gests there is a link between violence and severe mental illness but cautions that it is complex, multi-faceted, and therefore difficult to clinically predict. 89 the study followed roughly one thousand severely mentally ill individuals after dis­ charge from inpatient hospitals and measured their rates of violence at two key intervals: at the initial five month mark after release and at the full year mark after release.90 for persons with schizophrenia, bipolar disorder, and depres­ sion, the one year rate of violence post discharge was 17.9% compared to a lower 10.1% after the first five months post discharge.91 hence, the longer time after discharge-the greater the distance from the time intensive treatment is administered-the more likely violent acts were to be committed. 92 the mac­ arthur study also challenged (inadvertently) the reliability of single categorical correlations between delusions, hallucinations, anger, or violent thoughts and violent acts by severely mentally ill individuals. 93 while most individuals suffering from a severe mental illness are not vio­ lent, researchers tend to agree that a small percentage seem to have a violent propensity.94 nonetheless, there fails to be a magic bullet study linking any particular risk factor or symptom of any particular severe mental illness with 84 id at 47 (including whether or not the individual is living with a non-mentally ill fam­ ily member at the time). 85 compare id. at 48 (citing a swedish study that found severely mentally ill men and women were 4.2 and 27.5 times more likely, respectively, to have committed a violent crime compared to controls) with skeem et al., supra note 81, at 967 ("(t]he nuances of the relation­ ship between mental disorder and violence remain elusive."). 86 torrey, out of the shadows, supra note 74, at 46 {regarding a study conducted in 1992 by bruce link and his colleagues at the new york state psychiatric institute). 87 e.g., id. at 50. 88 /d. at 53-54. 89 monahan et al., ma.car1hur study, supra note 80, at 142 {"perhaps unsurpris­ ingly, the complexity of human behavior has thus far frustrated ... attempts to find unitary causes of and solutions to violen[t acts committed by severely mentally ill individuals].") 90 /d. at 63-64,64 tbl.4.1. 91 !d. 92 seeid 93 /d. at 77, 80, 85, 89 (arguing. however, that such symptoms are still important :fuctors to consider when predicting violence among the severely mentally ill). 94 see, e.g., torrey, surviving scmzophrenia,supra note 12, at 306. 2007] toward a twenty-first century civil commitment statute 379 future violent acts.95 e. medication and other forms of treatment today, medication is the primary course of treatment for severe mental illnesses. schizophrenia, for example, "[ c ]ontrary to the popular stereotype, is an eminently treatable disease'.% even though the cause and cure are still un­ known. 97 schizophrenia is also a chronic mental illness, so even though treat­ ment measures are available, it tends to be a lifelong illness that never fully disappears even with the most successful treatments. 98 while medication has proven to be the most effective treatment for schizophrenia, 99 and in turn dra­ matically improves the quality of life for such individuals,100 it is not the only treatment available. psychotherapy,101 cognitive behavioral therapy, electro95 !d. even so, the macarthur study is widely known for having offered practitioners a multi-variable risk assessment tool that bas since been used by many researchers in predicting future acts of violence by severely mentally ill individuals. see monahan et al., ma.car1hur study, supra note 80, at 113. it is described by its authors as an "interactive and contingent model of violence, one that allows many different combinations of risk factors to classify a per­ son as high or low risk." !d. (including clinical variables, such as diagnosis, delusions, psycho­ pathy, violent thoughts, and hallucinations, and criminological variables, such as prior violence and criminality, gender, neighborhood, and child experiences). the macarthur study reports that no single intervention is likely to enable the successful management of potential violence. multiple targets for intervention will exist, and they will differ from per­ son to person. the multivariate interactive causal model of violence that is most consistent with our data ... implies that effective interventions need not eliminate all or even most of a person's risk factors. it should be sufficient only to reduce the presence of these factors below the threshold ... at which their combined ef­ fect is likely to cross the threshold at which violence occurs. id. at 143. the 2006 study undertaken by skeem et al., like many prominent studies in the field, employed the macarthur actuarial risk assessment tool. skeem et al., supra note 81, at 969, 976. 96 torrey, surviving schizophrenia, supra note 12, at 156. 97 "successful treatment means the control of symptoms, whereas cure means the perma­ nent removal of their causes." !d. 98 see, e.g., michelle kramer et al., paliperidone extended-release tablets for preven­ tion of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study, 27 j. clinical psychopharmacology 6, 6 (2007). see also saks, refusing care, supra note 18, at 51 ("[s]ome mentally ill people ••. are treatable to only a modest degree."). 99 torrey, surviving scmzophrenia, supra note 12, at 196, 199 (stating that studies show approximately seventy percent of persons with schizophrenia significantly improve if they take first generation antipsychotics, such as chlorpromazine or thorazine). 100 cf. jeanette hewitt, critical evaluation of the use of research tools in evaluating quality of life for people with schizophrenia, 161nt'lj. mentalhealmnursing 2, 2 (2007) (describing tools for measuring the quality oflife for severely mentally ill individuals including independence, the absence of pain, and the ability to be physically active). 101 paul h. lysak:er et al., psychotherapy and recovery in schizophrenia: a proposal of 380 indiana health law review [vol. 4:361 convulsive therapy, and nutritional treatments often supplement and enhance medication-based treatments of schizophrenia. 102 further, most of the antipsy­ chotic medications used to treat schizophrenia only help to treat the positive symptoms and so medication should be supplemented with other forms of treatment to help cope with the negative and cognitive symptoms of the dis­ ease. ioj one of the major problems with medication as a form of treatment for se­ vere mental illness is ensuring that the patient adheres to the medication, which is sometimes also related to lack of insight into the illness. in many cases, pa­ tients may begin to feel better once regularly taking medication and decide to stop taking it precisely because they feel they have recovered. in other cases, patients who experience side effects, such as movement disorders, 104 weight gain, 105 or sexual dysfunction eventually stop taking their medication in order to key elements for an integrative psychotherapy attuned to narrative in schizophrenia, 4 psychol. servs. 28, 35 (emphasizing the need for psychotherapy and developed narratives as part of the treatment course for schizophrenia); saks, refusing care, supra note 18, at 119; saks, the center cannot how, supra note 72, at 185, 187-88 ("psychoanalytical treatment kept me out of the hospital while i actually completed my oxford degree."). 102 e.g., torrey, surviving schizophrenia, supra note 12, at 184-94. see also dllkakis & tye, supra note i 0 (discussing the therapeutic benefits ofect). 103 p .f. buckley & s.m. stahl. pharmacological treatment of negative symptoms of . schizophrenia: therapeutic opportunity or cul-de-sac?, 115 acta psychiatrica scandin­ avica 93, 94 (2007). recent research suggests that a new drug may treat both negative and positive symptoms of schizophrenia. sandeep t. patil et al., activation of mglu2/3 receptors as a new approach to treat schizophrenia: a randomized phase 2 clinical trial, 13 nature med. 1102 (2007); see also alex berenson, new schizophrenia drug shows promise in trials, n.y. times, sept. 3, 2007, at a9. additionally, recent evidence suggests that the use of antidepressants to treat the nega­ tive symptoms ofbipolar disorder is ineffective. leading researchers to believe that better treat­ ment for this disorder may lie in the use of antipsychotics. karen auge, antidepressants fail in bipolar test, denv. post, mar. 29, 2007, at al9 (citing the results of a seven year study re­ cently released and funded by the national institutes ofhealth surveying twenty-two sites across the country and roughly five thousand bipolar patients). 104 kramer et al., supra note 98, at 6; mccreadie, supra note 64, at 21, 24 (describing two types of movement disorders: 1) parkinsonian side-effects such as tremor and rigidity, which usually require prescription of anti-parkinsonian medication and 2) tardive dyskinesia that may result in abnormal movements of the filce). 105 another criticism of the use of medication as the primary form of treatment for severe mental illnesses is that side-effects, such as weight gain, may lead to other medical and public health issues for this population. indeed, some studies have indicated a possible link between the use of second generation antipsychotics and the development of adult obesity and diabetes, conditions which raise other serious medical concerns. christopher reist et al., second­ generation antipsychotic exposure and metabolic-related disorders in patients with schizo­ phrenia: an observational pharmacoepidemiology study from 1988 to 2002, 27 j. cllnical psychopharmacology 46, 49, 50 (2007). see also jose de leon, weight gain during a dou­ ble-blind multidosage clozapine study, 27 j. clinical psychopharmacology 22, 22 (2007) (noting that the incidence in weight gain is higher with the medication clozapine compared to olanzapine but suggesting that "base-line [body mass index], dosing, and, possibly, the afi:ican­ american race may be major determinants of clozapine-induced weight gain."). 2007] toward a twenty-firstcenturycivjlcommitmentstatute 381 avoid the side effects. this type of self-administered drug withdrawal can be very dangerous for persons with severe mental illnesses because there is some evidence that psychiatric medications are less effective after a patient has with­ drawn from them. 106 nonetheless, recent studies show that newer, second­ generation antipsychotics have fewer side-effects than first-generation antipsy­ chotics. 107 other researchers are looking for ways to ensure that the very form and chemical structure of a medication helps to improve treatment adherence.108· for example, extended-release tablets109 and depot injections110 have been used as alternatives to taking daily oral pills. with depot injections, the patient may be required to report to an outpatient facility where a provider will inject the medication on a bimonthly or monthly basis depending on the medication.111 the injection method has been criticized, not only because it can lead to pro­ longed pain at the injection site, but also because the injection remains in the bloodstream for roughly two weeks.112 consequently, patients utilizing the in­ jection method are unable to avoid the negative side-effects once the injection has been administered. new research suggests that small biodegradable devices 106 some studies show that providers need to be careful when lowering the dose of antip­ sychotic medication for a patient "below the level to which the patient initially responded." because the lower administered dosage may lead to a relapse or problems with future treatment e.g., i. lipkovich et al., predictors of risk for relapse in patients with schizophrenia or schizoaffective disorder during olanzapine drug therapy, 41 j. psychiatric res. 305, 309 (2007). in general, "[ r]elapse has been attributed to a variety of factors, including poor compli­ ance with antipsychotic drug therapy, inadequate dosing, residual psychopathology, poor insight into the illness and need for treatment, comorbid substance abuse and poor relationships be­ tween patients, families and care providers." /d. 107 e.g. torrey, survlving schizophrenia, supra note 12, at 216 (noting fewer parkin­ sonian-like symptoms in particular). clozapine, a key second-generation antipsychotic, was first introduced to the u.s. in 1990. see id at 197,219-20. see also peter malik. sexual dysfonc­ tion in schizophrenia, 20 current opinion in psychiatry 138, 141 (2007) (showing reduced sexual side effects in second generation antipsychotics). 108 contrary studies suggest that the best predictor of whether or not a severely mentally ill individual adheres to medication is a care provider's genuine explanation ofhow and why the individual needs to take the medication. cf. richard gray et al., adherence therapy for people with schizophrenia, 189 brit. j. psychiatry 508, 508-09, 511 (2006){concluding that directly involving patients in understanding their medication had roughly an equal adherence rate with broader general health education). 109 kramer et al., supra note 98, at 6, 12 (2007) (discussing the positive findings of the twenty-four hour drug release tablets). 110 kayla l. metzger et al., pharmacokinetic and behavioral characterization of along­ term antipsychotic delivery system in rodents and rabbits, 190 psychopharmacology 201, 202 (2007). 1l1 see torrey, survlving schizophrenia, supra note 12, at 199. patients not reporting to an outpatient facility may be required to self-administer the injections roughly twenty-four times a year. metzger et al., supra note 110, at 202. 112 metzger et al., supra note 110, at 202. 382 indiana healtii law revmw [vol. 4:361 may also be used to physically implant psychiatric medication into the body.113 such a device would be surgically implanted, and therefore, at the first sign of a negative side-effect it could be immediately (surgically) removed. 114 medica­ tion administered in this manner would remain effective for up to six months (and would be biodegradable), assuming that the onset of negative side-effects did not necessitate its removal. 115 it should also be noted that recent improvements in the tools of diagnostic medicine, such as history and mental status examinations, physical and neuro­ logical examinations, blood count and urinalysis, psychological tests, mri and ct scans, lumbar punctures, and eegs have made diagnosing severe mental illnesses much easier today. 116 some studies even suggest that brain scans taken of individuals with a family history of diseases, such as schizophrenia, may be able to predict whether the individual is likely to develop the disease before any negative onset. 117 understanding the current medical nature of se­ vere mental illnesses is critical because it reveals the truth as to how mental illnesses operate and helps those in the legal field detennine how to draw the appropriate balance between civil liberties, public and private health, and pro­ tecting citizens from harm. n. robert's story: a human face to the f allures of the danger­ or-ora vb-disability statutes meet robert.118 he is forty-seven years old and was diagnosed with para­ noid schizophrenia twenty years ago.119 he has been homeless for roughly the 113 /d. 114 id 115 id at 202, 206-07 (noting that it may take up to two weeks for the medication to begin to work, which is also typical of other forms of medication). 116 torrey, survivlng scmzophrenia, supra note 12, at 162-66. see also paull. wegkamp, jr., thenor111umberland nioiitmare: when justiceignoresmentaliu.n:ess 95 (2004) ("the [ct] scan shows that chad has neurological damage in the form of enlarged cere­ bral ventricles .... the cavities become enlarged because of the loss of brain tissue, putting pressure on the brain."). 117 bridget m. kuehn, brain scan may predict schizophrenia, 291 j. am. meo. ass'n 253, 253 (2007). these brain scans focus on the theory that "a reduction of the brain's gray matter precedes the onset of schizophrenia." id 118 robert gilmore is one of the mentally ill individuals on doctor e. fuller torrey's ''preventable tragedies" web site. dr. torrey, one of the leading activists ofpvot, keeps a web site of preventable tragedies that have occurred in the united states from 1987 to the pre­ sent date. treatment advoc. ctr., "preventable tragedies" database search, http://www.­ psychlaws.org/ep.asp (last visited feb. 18, 2006). at least 3,000 deaths have occurred since dr. torrey and the treatment advocacy center starting keeping tally of incidents from various statewide news articles. /d. nonetheless, each of these deaths is somehow related to a diag­ nosed mentally ill individual who remained untreated in the community. id 119 id. 2007] toward a twenty-flr.stcenturyclvilcommitmentstatute 383 same period oftime.120 robert has also been arrested more than forty times.121 the charges are generally for wandering onto public property, urinating in pub­ lic, or disobeying an officer. 122 his family continually offers him shelter, fi­ nances, and care, but he repeatedly declines such offers and chooses to live on the streets, alone. 123 robert is not receiving any treatment for his paranoid schizophrenia. 124 recently, robert was arrested when asked to leave a municipal parking garage in his hometown in kansas, presumably for seeking shelter from the winter cold.125 he struck a police officer when asked to leave and was taken to jail.126 his mother and brother picked him up upon his release but robert de­ clined their financial and housing assistance yet again. 127 robert chose to re­ turn to the streets, without any income, companionship, or stable shelter, instead accompanied by his untreated symptoms of paranoid schizophrenia.128 a. robert's chances for treatment under a typical danger-or-grave­ disability statute robert's violent action of striking a police officer (when being asked to leave the public parking garage) fails to meet the threshold of most variations of the danger-or-grave-disability statutes. striking a police officer with a fist is not a threat of "imminent" substantial bodily harm or death or a "substantial risk" that it might occur. likewise, robert's chronic homelessness does not meet either the "gravely disabled" or the imminent "danger of harm to self' standard. these statutory provisions would likely only help robert obtain in­ voluntary treatment if he began to manifest signs of severe malnutrition or mal­ function. this is premised on someone discovering robert and reporting him to an officer, by which time it may be too late. many would argue that robert's paranoid schizophrenia has taken hold of his life and liberty during at least twenty years of his life. notice that his fam­ ily, though arguably the most reliable witnesses to the development of his dis­ ease, has been unable to help him get the treatment he needs, even though he is chronically homeless and severely mentally ill. one way of thinking of this predicament is that it is robert's mental illness, and not robert himself, that has controlled his ability to comprehend the nature of his illness as it has grown 120 id. 121 id. 122 see id. 123 id. 124 see id 125 id. the arrest took place in december of2004. id 126 id. 127 /d. 128 see id. 384 indiana health law review [vol. 4:361 into him over the last twenty years.129 each year, he loses more insight and grows into the illness even further. schizophrenia has disordered his thinking and his very ability to consent to the point that he does not recognize that he needs help. through the application of robert's case to the "danger or grave disabil­ ity" statutes, one can see that the public policy of these statutes is that robert should be free to live homeless though he is also diagnosed with a severe men­ tal illness, is in need of medical treatment, and has been arrested forty times for misdemeanor violations. this public policy trusts the severe mental illness over the medical and scientific evidence that his illness has impaired his very ability to consent. b. robert's chances for treatment under a pvot statute two factors make robert an excellent candidate for treatment under a pvot statute: his chronic condition and prior criminal record. the facts show that robert has been chronically homeless for twenty years and has had forty misdemeanor violations. medical and criminal history are two of several fac­ tors considered when determining whether robert is an eligible candidate for pvot .130 additionally, under a pvot statute, aside from a police officer mak­ ing an arrest, robert's parents or siblings could petition the court to have a mental health professional examine his condition, and the professional would then make recommendations to the court about a specific treatment regimen for him. if a court found that robert was a proper candidate for pvot by the tra­ ditional clear and convincing evidence standard, they could order him to begin taking medication. he might also be required to start meeting with doctors, social workers, and vocational counselors regularly to get him back to the point where he is able to function in society and begin to make some independent and arguably autonomous decisions131 in his life. in summary, involuntary outpatient commitment through a pvot statute has the power to give robert-a non-violent but severely mentally ill homeless individual-his liberty back as opposed to fostering neglect for an illness that is destroying his personality and dignity. with medication, robert may hold a job, find meaningful relationships, or live in a home ofhis own someday. the options of meaningful choices and lifestyles are greatly enhanced. 132 129 torrey, surviving scmzophrenia. supra note 12, at 51. see supra note 77 and accompanying text (discussing insight). 130 see infra part v. 131 seestephendarwall, the valueofautonomyandautonomyofthe will, 116enncs 263, 265 (2006) (identifying four types of autonomy one of which is rational autonomy). see also supra note 75 and accompanying text (discussing paternalism). 132 contra margo flug, no commitment: kendra's law makes no promise of adequate mental health, i 0 geo. j. on poverty l. & pol'y l 05, 108-09 (2003) (arguing that pvot is coercive and restricts liberty interests of mentally ill individuals). 2007] toward a twenty -first century civil commitment statute 385 v. the language of the model pvot statutes: kendra's law and laura's law the two primary pvot statutes currently in existence are those ofnew york and california: kendra's law and laura's law, respectively. each law takes the name of an innocent-bystander victim who was killed as a result of the impulsive and violent actions of chronically mentally ill individuals who re­ mained untreated in the community, though family members had tried for years to obtain treatment for them. kendra webdale, an aspiring writer in her early­ thirties, was killed by a man suffering from schizophrenia who randomly pushed her off a new york subway platform and into an oncoming train.133 laura wilcox, a nineteen-year-old, was killed by an individual diagnosed with schizophrenia in a random-fire shooting along with two other innocent vic­ tims. 134 though similar to one another in form, kendra's law and laura's law each represent slightly different policy positions on pvot. since their enact­ ment, several other jurisdictions have sought to adopt similar legislation. 135 one unifying concept, among others that will be discussed in more detail below, is that treatment plans under pvot statutes typically start with an initial six months of forced treatment and are available for renewal depending upon the patient's progress. 136 hence, they are unique compared to other aot stat133 kendra webdale was killed by andrew goldstein. a twenty-nine-year-old jobless, college dropout ''who had a history of schizophrenia and violent assaults." fritz, supra note 8, at al2. a unique factor in kendra's case was that andrew goldstein" 'voluntarily sought commitment or supervised living thirteen times prior'" to killing kendra ... but due to lack of resources, such as hospital beds, he was refused adequate treatment each time. plug, supra note 132, at 111-12 (quoting a new york state report on quality care for the mentally ill). 134 laura wilcox was the youngest of the victims when in 2001 "a deranged catfish farmer went on a rampage in a small northern california town, killing three people and igniting public outrage." fritz, supra note 8, at a12. 135 see infra part vi. 136 compare laura's law, cal. welf. & inst. code§ 5346(g), (h) (west supp. 2007) (stating that the initial order is not to exceed 180 days but every sixty days the director of the pvot program shall file an affidavit affirming that the person still meets the pvot criteria at which time the person subject to the pvot commitment has a right to a hearing) with kendra's law, n.y. mental hyg. law§ 9.60(jx2), (k) (mckinney 2006) (stating that the initial treat­ ment period ofpvot shall not exceed six months; petitions for additional periods of treatment must be made within thirty days prior to expiration of the pvot order in which the court may order pvot for a further period not to exceed one year). new york's kendra's law permits for an arguably more stable and longer lasting treatment period compared to california's laura's law. one of the key reasons that a lengthier initial treatment period is used in pvot stat­ utes is that medication does not always instantly become effective once it is taken. torrey, surviving scmzophrenia, supra note 12, at 204. "on one end of the clinical spectrum are individuals who respond dramatically within forty-eight hours of being started on medication, whereas on the other end are individuals who respond very slowly over several months." id in one prominent study of first-episode patients with schizophrenia, the mean interval between starting medication and achieving the estimated maximum clinical improvement was thirty-five 386 indiana health law review [vol. 4:361 utes, including danger-or-grave-disability statutes, which typically only pennit an initial, brief "seventy-two hour hold,"137 followed by further holds only so long as the danger-or-grave-disability criteria continue to be met therefore, under the danger-or-grave-disability statutes, many severely mentally ill persons are released back into the community too soon because they fail to continue to meet the danger-or-grave-disability criteria during the first seventy-two hour hold. failure to meet commitment criteria might occur if a medication begins to work during the briefhold, or in the alternative, moods, psychotic breaks, or emotions cool. pvot statutes address this problem directly by providing for lengthier initial treatment periods. understanding the different policy approaches taken through the specific language ofkendra's law and laura's law will help shed light on the kinds of choices that legislatures and public policy makers have when deciding whether or not to implement pvot. at the same time, this analysis will highlight the general goals and primary functions of pvot statutes. a. kendra's law ofnew york 1. eligibility requirements kendra's law138 requires that seven evidentiary elements each be met by clear and convincing evidence139 in order for a person to receive pvot in the state ofnew york.140 each of the seven elements is distinct and detailed. ad­ ditionally, the very nature of requiring seven separate prima facie evidentiary elements to trigger pvot eligibility suggests the statute is narrowly drawn and that its scope targets a specific population of severely mentally ill individuals. the seven statutory elements for pvot treatment eligibility are as follows. first, in order to be eligible for pvot the mentally ill individual must be at least eighteen years old.141 therefore, children and teenagers are not subject to kendra's law. second, the individual must be "suffering from a mental illweeks, or roughly nine months, though half of the patients had achieved maximum improvement by eleven weeks, or roughly three months. id (citing a study conducted by dr. jeffrey lieber­ man and his colleagues). the initial six month commitment order under pvot statutes there­ fore is medically critical to assisting severely mentally ill persons in making genuine headway toward recovery. 137 see generally bebe moore campbell, 72 hour how passim (2005) (illustrating through fiction a parent's struggle to obtain treatment for an adult child under california's dan­ ger-or-grave-disability statute, the lanterman-petris-short act). 138 kendra's law, n.y. mental hyg. law§ 9.60 (mckinney 2006). kendra's law became effective in 1999 and currently has a sunset provision in 2010 (unless amended or de­ leted before that date). id. see also kendra's law, ch. 408, 1999 n.y. laws 2870 (codified at n.y. mentalhyg. law§ 9.60). 139 id. § 9.60(jx2). 140 see id § 9.60(cxi)-(7). 141 id § 9.60(cx1). 2007] toward a twenty-first century civil commitment statute 387 ness .... " 142 this determination requires a clinical diagnosis by a mental health provider. nevertheless, it should be noted that the severity of the mental illness is not at issue for this criterion; all that is required is a diagnosis of a mental illness that presumably causes the person to suffer in some respect. third, the individual must be "unlikely to survive safely in the community without supervision, based on a clinical determination .... "143 this provision gives power to the medical professional to determine whether the individual is capable ofliving safely on his or her own. concomitantly, the criterion targets the severity of the illness as it focuses on whether "supervision" is needed in order for the individual to "survive safely."144 fourth, the individual must have a "history of lack of compliance with treatment for mental illness" that has manifested itself in one of two situations, not including any incident within the most recent six months: 145 1) psychiatric hospitalization or receipt of psychiatric services in a correctional facility at least twice within the last three years; 146 or 2) at least one act of, threat of, or attempt at, "serious physical harm to self or others" within the last four years. 147 the second prong of the fourth criterion is similar to the danger statutes. yet, terms such as "threat of' or "attempt at" move away from the immanency-type stan­ dards typically required of the danger statutes. so albeit similar, this broadens the scope of what would traditionally be considered evidence under a danger­ or-grave-disability statute. the first prong of the fourth criterion, however, is more clearly a move­ ment away from the danger-or-grave-disability statutes into new civil commit­ ment territory. the frrst prong considers the medical history of the illness but further limits this into three subcategories that each must be present for the evi­ dence to be admissible: 1) the medical history must be confmed to either inpa­ tient psychiatric hospitalization or receipt of psychiatric services in jail or prison, 2) that such medical history is only considered within the most recent three year period, excluding the most recent six months (excluding any receipt of services administered on the single incident that led to the civil commitment order), and 3) that there are at least two separate incidents (excluding the most recent six months) of psychiatric treatment in these physical environments. so while on the one hand the introduction of medical history of the illness seems to be a broad expansion away from the danger-or-grave-disability statutes, the his142 !d. § 9.60(c)(2). 143 id. § 9.60(c)(3). one critic has argued that "unlikely" to survive in the community may be a vague substitute for a "competency" determination. gutterman, supra note 1 0, at 2437. 144 in many senses, this sounds like the gravely-disabled prong of the danger-or-grave­ disability statutes. in time, how broadly or narrowly this criterion will be interpreted by the courts will show us how similar or different it is in function from the grave-disability prong. 145 n.y. mentalhyg. law§ 9.60(c)(4). 146 /d.§ 9.60(c)(4)(i). 147 /d. § 9.60(c)(4)(ii). 388 indiana health law review [vol. 4:361 tory is limited to a narrow population of mentally ill individuals: those who have been physically hospitalized or incarcerated. hence, receipt of medication through an outpatient treatment plan, even under a danger-or-grave disability statute, would not be admissible evidence. this is a weakness of the statute as it fails to protect a larger population of severely mentally ill individuals who may not have received medication in an inpatient facility (quite possibly due to the lack of availability of a bed in a hospital or the public policy of pursuing outpatient over inpatient treatment) or while incarcerated. nonetheless, a virtue ofthis criterion is that it seems to narrowly target a specific population of se­ verely mentally ill individuals: those who are typically incarcerated or physi­ cally hospitalized for their illness. 148 fifth, the individual, "as a result of his or her mental illness [must be] unlikely to voluntarily participate in outpatient treatment that would enable him or her to live safely in the community .... "149 this criterion asks whether the individual lacks sufficient insight into his or her illness and therefore would not voluntarily submit to treatment sixth, in view of the individual's history and current behavior, the individual must be in need ofpvot to "prevent a relapse or deterioration which would be likely to result in serious harm to the person or others .... " 150 while this criterion also rings similar in tone to the danger stat­ utes, the word "likely'' arguably reduces its burden; hence imminent or actual harm is not required. seventh, and finally, the individual must be "likely to benefit :from ... [pvot]."isi the absence of any one of these seven factors by a clear and convincing evidence standard denies pvot eligibility. 152 certainly, far more power is given to the medical professional in helping the court determine whether the civil commitment should be ordered since much of the focus of the statutory language is on the severity of the illness and various ways it might manifest itself. but kendra's law is a middle ground approach as there is still a high evidentiary burden built into the statute. the combination of medical and legal limitations in the eligibility criteria makes kendra's law one that will likely only be considered by attorneys in cases in which a severe and persistent mental illness is at issue. the fourth criterion ofkendra's law seems to be one of the most critical requirements that deserves further discussion. the requirement focuses on the individual's history of mental illness and the extent to which it has manifested 148 see kendra's law, ch. 408, 1999 n.y. laws 2870 (codified at n.y. mental hyg. law§ 9 .60) (''the legislature finds that there are mentally ill persons who are capable ofliving in the community with the help of family, friends and mental health professionals, but who, without routine care and treatment, may relapse and become violent or suicidal, or require hos­ pitalization.") 149 n.y. mentalhyg. law§ 9.60(c)(5). iso /d. § 9.60(c)(6). lsi /d. § 9.60(c)(7). is2 /d. § 9.60(j). 2007] toward a twenty-firstcenturycivilcommitmentstatute 389 itself in prior hospitalization, forced medication while in jail, or prior acts of violence. it permits events dating back to a maximum of three years for hospi­ talization and four years for violence to be used as evidence in the petition for treatment-but it goes no further. 153 hence, the nature of this criterion is such that it is likely to effectively distinguish between severely mentally ill persons and those persons who suffer from more minor conditions of mental illness. certainly, there are many "mentally ill'' persons who have not been hospitalized or incarcerated as a result of their illnesses. kendra's law does not seek to force treatment on such persons. instead, the fourth criterion seeks to identify an emerging pattern of symptoms in those chronically and severely mentally ill persons, while additionally balancing civil liberties of the subpopulation by not permitting evidence of the illness dating back further than either three or four years, depending on the provision being applied. 154 to understand better how kendra's law might screen out certain non­ severely-mentally-ill individuals, and further illustrate the intricacies of the fourth criterion, it may be useful to consider the story of robert gilmore again (the homeless forty-seven-year-old who suffers from paranoid schizophre­ nia).155 depending on the circumstances, it is possible that even robert would not be eligible for pvot under kendra's law. though we know robert has been arrested in his hometown forty times in the last twenty years, we do not know how many arrests he has had within the last three years that have resulted in incarceration or hospitalization (excluding the most recent six months, which would include his striking a police officer that led to the most recent arrest). this is the critical question under kendra's law. let us assume that his eligi­ bility hinges on the ftrst prong of the fourth criterion (two incidents of receipt of psychiatric services in a hospital, jail, or prison).156 assuming this, either one of two scenarios must have occurred in his recent past for him to be eligible for pvot under kendra's law. the ftrst is that, to be eligible for pvot, robert must have been incarcer­ ated on two separate occasions within the past three years that each resulted in receipt of medication, excluding the most recent six months. this is not easy to establish unless one is severely mentally ill and has been incarcerated. being 1s3 for details on the application of this criterion under new york. law see in re dailey, 713 n.y.s.2d660, 662-63 (n.y. sup. ct. 2000}(regardinginpatientbospitalization). see also n.y. state office of mental health, kendra's law: final report on the status of assisted outpatient treatment app.2 at 45-47 (2005). 1s4 contra gutterman, supra note 10, at 2434-35 ("civil libertarians and patients' rights advocates vigorously oppose outpatient statutes, such as kendra's law ... they fear that such legislation is nebulous because it fails to delineate clear criteria for outpatient commi1ment, and will ultimately restore high rates of inpatient commi1ment."). tss see supra part iv. 156 since be was not a "danger to himself or others" when striking a police officer, this aspect of the fourth criterion is not discussed. see id. 390 indiana health law review [vol. 4:361 arrested but not incarcerated will not meet the criterion.157 further, in robert's case it is certainly possible that he was not medicated on any of the forty occa­ sions he was arrested and incarcerated (and this is assuming he was taken to jail upon arrest and there was a need to medicate). but if robert had been medi­ cated under such circumstances, kendra's law asserts this would be highly probative ofhis deteriorating and unstable condition. seen in this light, the first prong has established a high evidentiary standard that protects the liberty inter­ ests of non-severely mentally ill individuals who are not in need of pvot. even someone like robert might not be considered severely ill enough, al­ though he has been homeless for twenty years due to his illness and has been arrested forty times. therefore, an inherent weakness of kendra's law is that, under certain circumstances, it may require literal "criminalization of the men­ tally ill" before it will step in to assist severely mentally ill persons. in light of this type of policy consideration, state legislatures might consider omitting the actual incarceration-coupled with forced medication-requirement of kendra's law and supplementing a requirement of high incidence of arrest, possibly even for misdemeanor crimes that result in a fine or ticket. second, in alternative to the first option described above, robert must have been hospitalized (either by voluntary or involuntary means) twice within the last three years, excluding the most recent six months. clearly, this stan­ dard of proof is not analogous to an individual who seeks out counsel or medi­ cation from a psychiatrist, general practitioner, or psychoanalyst, independent of hospitalization. nor is it analogous to an individual who meets with a psy­ chiatrist in his or her office upon an outpatient basis. hence, accepting medica­ tion based on a voluntary doctor-patient relationship outside of a hospital setting is not the type of evidence that would ever meet this burden. the nature of this aspect of the fourth criterion relies inherently on the existing danger-or­ grave-disability statutes. thus, a critique of this provision is that it requires a nearly impossible threshold for the state to meet since most danger-or-grave­ disability statutes require actual, imminent, or substantial risk of harm or ex­ treme grave disability. nonetheless, a strength of the eligibility requirements under kendra's law is that it seeks to protect the liberty interests of severely mentally individu­ als to a high degree. it is very conservative in its willingness to depart from the danger-or-grave-disability statutes. provisions that do diverge from the danger­ or-grave-disability statutes seem to be highly cautious in their initial construc­ tion. the general requirement of three or four years of medical history that re­ sults in forced medication (an oversimplification) also fails to address younger individuals who may be developing a severe mental illness. kendra • s law re­ quires, in effect, that the individual continue to deteriorate for at a minimum of 157 it is also possible that some arrests that might typically result in jail time (at least awaiting trial) are waived because the police officer bas past experience with the individual and knows he or she is severely mentally iu. 2007] toward a twenty -first century civil commitment statute 391 three years before being willing to step in with a pvot treatment plan. medi­ cal research shows, however, that those who begin manifesting signs of a severe mental illness have the greatest chances for recovery if they receive treatment at earlier stages.158 yet, kendra's law generally targets an older age bracket of those suffering from severe mental illnesses.159 nonetheless, because kendra's law's seven eligibility criteria comprise a difficult legal burden to establish, kendra's law addresses a narrowly defined group of severely mentally ill indi­ viduals. 2. third parties that may petition the court to determine eligibility another aspect of kendra's law, compared to some danger-or-grave­ disability statutes, is that parents or siblings of the severely mentally ill individ­ ual are among those who may bring a petition seeking treatment for the indi­ vidual.160 under kendra's law, eight classes of persons may file a petition 158 seetorrey,survivingschjzophrenia,supranote 12,at205-06("1n 1991 dr. rich­ ard wyatt reanalyzed twenty-two studies on the course of schizophrenia and concluded that 'early intervention with neuroleptics in first-break schizophrenic patients increases the likeli­ hood of an improved long-term course.' ... the implication of these studies is that the failure by mental illness professionals to treat individuals with schizophrenia with antipsychotic medi­ cations as early in the course of their illness as possible may produce a worse outcome."); see also wegkamp, supra note 116, at 78,252 (describing a family's struggle to obtain treatment for their college-age son diagnosed with schizophrenia after an initial psychotic episode). but cf. torrey, surviving scmzophrbnia, supra note 12, at 102-03 ("in general, the younger the age at which schizophrenia develops, the poorer the outcome. a person who is first diagnosed with schizophrenia at age fifteen is likely to have a poorer outcome than a person with the onset at age twenty-five.'') 159 this leads one to wonder how preventive kendra's law really is in effect. 160 see kendra's law, n.y. mental hyg. law § 9.60(d) (mckinney 2006). but see ala. code § 22-52-1.2 (lexisnexis 2006) (permitting any person to file a petition seeking the involuntary commitment of another person provided, among other criteria, that the petitioner "has reason to believe the respondent is mentally ill" and "that the beliefs of the petitioner are based on specific behavior, acts, attempts, or threats" specified in detail); ark. code ann.§ 2047-207 (2001 & supp. 2005) (requiring, however, thatthepetitionerstatewhethertheperson is believed to be a danger to himself or herself). yet, seeking a pvot order is not the only route by which a family member may peti­ tion the court for involuntary treatment of a severely mentally ill individual in both new york and california. under the danger-or-grave-disability statutes, such petitions are permitted so long as they are accompanied by a certified physician's statement that the civil commitment criteria are met. n.y. mental hvo. law § 9 .27(b ), (d) (stating that an application for involun­ tary treatment may be filed by "any person with whom the person alleged to be mentally ill re­ sides[,] ... the father or mother, husband or wife, brother or sister, or the child of any such person or the nearest available relative[,] .. .'' and several other professionals who may have knowledge of the alleged mental illness); lanterman-petris-short act, cal. welf. & inst. code § 5201 (west 1998) ("any individual may apply to the person or agency designated by the county for a petition alleging that there is in the county a person who is, as a result of mental disorder a danger to others, or to himse~ or is gravely disabled, and requesting that an evalua­ tion of the person's condition be made."). see infra notes 179-80 and accompanying text (dis392 indiana health law review [vol. 4:361 requesting that an individual receive pvot. first, a person who is eighteen years or older ''with whom the subject of the petition resides" may file a petition. 161 on the one hand this sounds broad, but because the petitioner must be an adult who also lives with the individual it is far narrower than one might initially imagine. though the issue has not as yet come before the new york courts, the statute would likely be interpreted to exclude those, for example, living in the same apartment complex building but in different apartments. likewise, it would likely exclude neighbors who live in adjacent homes from filing a petition on someone they suspect to be suffer­ ing from a severe mental illness, no matter how genuine the petition. nonethe­ less, the emphasis on having a residence, in general, may not encompass a fair amount of severely mentally ill persons and therefore may not make the most sense when aiming to protect this class of persons. after all, a sizable propor­ tion of severely mentally ill persons have no residence. many, such as robert, 162 are homeless or are incarcerated in some capacity. second, "[a] parent, spouse, sibling eighteen years of age or older, or child eighteen years of age or older" may file a petition seeking treatment for a mentally ill relative.163 nieces, nephews, uncles, aunts, grandparents, grand­ children, and cousins are not on the list, and will not have authority to bring a petition, unless they are over eighteen and reside with the subject of the peti­ tion. while it seems the policy of this pvot statute is to target those emotion­ ally closest to the severely mentally ill individual, strict familial lines may be a weakness of the statute.164 for example, it leaves open the question of whether step-parents and half-siblings would equally qualify. additionally, the general familial-emotional-attachment policy of the statute is inherently rebutted by the fact that most severely mentally ill persons have few emotional attachments. some may be estranged from family members or have moved across the coun­ try and broken ties. in such a situation, a more pragmatic statutory provision of one who may bring this petition makes better sense. for example, an apartment neighbor or landlord who believes the individual may be in need of treatment because of specific reports or evidence they might have obtained. hence, other states may wish to implement broader classes of persons who may bring a peti­ tion for pvot based on these potential shortcomings of kendra's law. the third through eighth groups of persons who may bring a petition to cussing further the lanterman-petris-short act and identifying those who may file a petition under laura's law in california). 161 n.y. mentalhyg. law§ 9.60(e)(l)(i). ltishigblyunlikelythataroommateofshort duration (such as college donn residents) would qualify because of the requirement that the illness must have manifested itself at least twice within the past three or four years in either hos­ pitalization or forced medication during incarceration. 162 see supra part iv. 163 n.y. mental hyg. law§ 9.60(e)(l)(ii). 164 cj. moore v. city ofeast cleveland, 431 u.s. 494,495-96, 503-04, 506 (1977)(strik­ ing down a city housing ordinance that excluded grandparents from the definition of family). "especially in times of adversity ... the broader family has tended to come together for mutual sustenance and to maintain or rebuild a secure home life." id at 505. 2007] toward a twenty-flrstcenturycivilcommitmentstatute 393 the court include medical professionals and police officers who have past ex­ perience with the particular individual sought to be treated. 165 while these final categories of persons authorized to file a petition make a great deal sense, one would also query as to whether any person over eighteen--for example, a teacher, landlord, neighbor, or supermarket owner-who has "past experience with the particular individual sought to be treated" might also be permitted to file a petition. should not the policy of the statute be to protect severely men­ tally ill persons over drawing explicit ties to residence partners, family mem­ bers, or mental health or law enforcement professionals? certainly, if such broad petitions were permitted to be filed they would need to continue to be screened for abuse. 166 though several classes of persons are statutorily authorized under kendra's law to file a petition on behalf of a severely mentally ill individual, the petition must also include the sworn statement of a physician, who has ex­ amined the person within ten days of the filing of the petition, which attests to the need for pvot.167 additionally, a person who files a "false petition" by "making a false statement or providing false information or false testimony in a petition or hearing" is subject to criminal prosecution.168 jurisdictions that wish to adopt kendra's law or a pvot statute similar to it should consider the pol­ icy positions it represents before enacting the identical language into law. b. laura's law of california laura's law uses virtually identical language to kendra's law, however, since it was modeled two years after kendra's law took effect, laura's law is modified in areas where kendra's law was vague or unclear. 169 for example, laura's law states at the front-end of the statute that a court must fmd each of the criteria by the "clear and convincing evidence" standard.170 in new york, while the same standard is applied under kendra's law, it is buried within the detailed language of the statute.171 hence, some of the revisions of laura's law are more technical than substantive, though initially they may appear oth­ erwise. 165 n.y. mentalhyg. law§ 9.60(ex1xiii)-(viii). 166 id. § 9.60(ex3)(i), (p). 167 id. § 9.60(ex3)(i). 168 id. § 9.60(p). 169 laura's law, cal. welf. & lnst. code§§ 5345-5349.5 (west supp. 2007). the bill was signed into law in 2002, and it became effective in 2003. assisted outpatient treatment demonstration project act of2002 ("laura's law''), ch. 1017, 2002 cal. legis. serv. 5046 (west); cal. treatment advoc. coalition. laura's law implementation, http://www.psychlaws.­ orgistateactivity/california.btm (last visited mar. 17, 2007). the law cummtly has a sunset provision set for 2013. cal. welf. & lnst. code § 5349.5(a). 17° cal. welf. & lnst. code § 5346(a). 171 cf n.y. mental hyg. law§ 9.60(jx2). 394 indiana health law review [vol. 4:361 1. eligibility requirements laura's law sets forth nine criteria that must each be met by clear and convincing evidence for an individual to receive pvot .172 seven out of those nine criteria are substantively identical to kendra's seven criteria. only two new eligibility criteria .are presented. compared to kendra's law, laura's -law's two additional criteria may raise the threshold for treatment eligibility slightly. first, laura's law requires that "the person's condition is substantially deteriorating."173 this "substantial deterioration" criterion does not appear radically different .from the narrower requirement of kendra's law (that laura's law also retains) that treatment be necessary ''to prevent a relapse or deterioration that would be likely to result in grave disability or serious harm."174 nonetheless, the criterion does seem to reflect a policy that deteriora­ tion of a mental illness is not only captured through evidence of grave disability or serious harm to self-or-others. yet, if the legislature thought this was the case, why would they retain the other provision that requires this specific find­ ing of grave disability or harm? hence, laura's law's requirement of a general finding that the individual's condition is deteriorating while retaining thenar­ rower finding that deterioration is likely to result in harm seems to be a revision without much effect. ltwould seem that other jurisdictions looking to model a pvot statute after laura's law should consider the policy implications of each before choosing whether to retain or omit the additional factor. a movement away from the danger-or-grave-disability statutes would be best reflected by retaining the broad criterion in laura's law and omitting the narrower criterion that requires a finding of likelihood of serious harm. second, laura's law requires that ''participation in the assisted outpatient treatment program ... be the least restrictive placement necessary to ensure the' person's recovery and stability."l7s while the least restrictive treatment doc­ trine is not constitutionally required, the doctrine has some constitutional status in civil commitment cases and requires that the recommended treatment be the least invasive treatment available before a physician orders it.176 nonetheless, 172 cal. welf. & inst. code§ 5346(axl)-(9). 173 id. § 5346(ax6). 174 /d.§ 5346(a)(8) (emphasis added); n.y. mentalhyg. law§ 9.60(c)(6). 175 cal. welf. & inst. code§ 5346(ax7) (emphasis added). 176 it has not yet been resolved as to whether the least restrictive alternative doctrine has constitutional status with respect to civil commitment proceedings. see youngberg v. romeo, 457 u.s. 307, 321. for support that the doctrine may have some constitutional status, see lake v. cameron, 364f.2d657, 660-61 (d.c. cir.1996),cert. denied, 382u.s. 863(1965)(remand­ ing for a determination of other available courses of treatment outside of inpatient treatment). "the alternative course of treatment or care should be fashioned as the interests of the person and of the public require in the particular case ...• [it is] the court's duty to explore alternatives in such a case." ld at 660. see generally ralph reisner, christopher slobogin & arti rai, law and'i'hembntalhealthsystem: civil and criminal aspects 750-51 (4thed. 2004). 2007] towarda twenty-firstcenturycivilcommitmentstatute 395 kendra's law also provides that the least restrictive treatment be used, how­ ever, it is detailed in a different section of the statute.177 even so, laura's law's codification of the least restrictive treatment doctrine up front in the stat­ ute may bring more clarity to courts and laypersons as to how the statute is to be applied. more theoretically, one has to wonder what the parameters of a doctrine such as the "least restrictive treatment" are in an era of psychiatric treatment that is more often administered in physically non-restrictive environments through taking medication. it will be interesting to see in the years ahead­ with a continued shift toward more outpatient treatment and medication-how the courts will begin to interpret this doctrine in light of psychopharmaceutical advances. 178 2. third parties that may petition the court to determine eligibility aside from laura's law's slight deviations from kendra's law with re­ spect to the treatment eligibility criteria, one of the biggest differences between the two statutes concerns those who are permitted to file a petition seeking medical treatment on behalf of a severely mentally ill individual. laura's law is more conservative than kendra's law and only allows the county mental health director to file the petition.179 similar to kendra's law, however, it permits nuclear family members, a person with whom the individual resides, or mental health experts and police officers with whom the individual has estab­ lished contact, to request that the mental health director file the petition.180 hence the language of the statute covers all of the same groups that kendra's law covers. it is prefaced, however, by the statement that "a request may be made only by any of the following persons to the county mental health depart­ ment for the filing of a petition to obtain an order authorizing assisted outpa­ tient treatment."181 one critique of this provision is that it makes a bureaucratic governmental system the threshold check, which could stymie the pvot application process. further, it is not established how the department will evaluate the requests for 177 n.y. mental hyg. law§ 9.60(j)(2). 178 for example, will least res1rictive mean the least side-effects? if so, who determines which side effects are more res1rictive than others? see also reisner, slobogin & rai, supra note 176, at 751-52 (citing browning hoffinan & lawrence foust, least restrictive treatment of the mentally ill: a doctrine in search oflts senses, 14 sandiegol. rev. 1100, 1139-43 (1977)). 179 cal. welf. &inst. code§ 5346(b). undercalifornia'slanterman-petris-shortact, which is the state's danger-or-grave-disability statute, any person may file a petition in good faith on behalf of another he or she believes to be severely mentally ill and in need of involun­ tary outpatient treatment. cal. welf. & inst. code§§ 5201, 5203, 5300(a) (west 1998). see supra note 160 for the precise language of the statute. 180 cal. welf. & inst. code§ 5346(b}(2). 181 id 396 indiana realm law review [vol. 4:361 filing the petitions. the counterargument, however, is that limiting the class of persons who may file a petition to the county mental health department allevi­ ates the risk of personal bias and will better ensure that civil liberties are upheld and fraudulent petitions are not filed. further, it is possible from a psychologi­ cal perspective that reserving the power to file a petition to the county mental health department will be less fraught with emotion than having someone with whom the individual has built emotional trust file the petition. 182 on the other hand, having those who know the individual best file the petition for outpatient treatment might better persuade the individual to comply with treatment if the severely mentally ill individual sees that those who care for him or her believe psychiatric treatment is needed, it is possible the severely mentally ill individual might be more likely to comply with treatment. vi. jurisdictions that have modeled legislation after kendra and laura laura's law and kendra's law each provide slightly different policy po­ sitions that other jurisdictions may follow or learn from. florida, michigan, and ontario, canada, have enacted pvot statutes similar to laura's law and kendra's law. new mexico, tennessee, and ohio currently have pvot bills pending. new jersey's legislature has also recently proposed a pvot bill, but in light of the strength of the opposition, it does not appear likely that pvot will be adopted in new jersey at this time. a. enacted pvot statutes florida's pvot law became effective in 2005.183 it is virtually identical to laura's law in having incorporated eight of the nine criteria set forth for treatment eligibility of a mentally ill individua1.184 florida's pvot statute, however, further limits the number of persons who may file a petition for treat­ ment in comparison to both kendra's law and laura's law. the only persons who may file a petition are "[t]he administrator of a receiving facility; or ... 182 see generally perlin. supra note 3, at 206 (analyzing kendra's law from a therapeutic jurisprudence perspective). 183 fla. stat. ann. § 394.4655(l){a)-(i) (west supp. 2007); act of june 30, 2004, ch. 385, 2004 fla. laws 2964. the law was initiated after a plumber who was severely mentally ill wounded two deputies in 1998 and shot another to death. fritz, supra note 8, at al2. 184 see fla. stat. ann. § 394.4655(l)(a)-(i) (west supp. 2007); compare with cal. welf. & inst. code§ 5346(a)(l)-(9). florida's pvot statute omits the criterion in laura's law that requires a general finding that the ''person's condition is substantially deteriorating." compare fla. stat. ann.§ 394.4655(1) with cal welf. &inst. code§ 5346(a)(6). there­ fore, the florida statute retains nine criteria total, having split one criterion oflaura's law into two parts. compare fla. stat. ann. § 394.4655(l){d), (e) with cal. welf. & inst. code§ 5346(a)(4). 2007] toward a twenty-first cenfury cml commitment statute 397 [ t ]he administrator of a treatment facility. "185 there is nothing written into the statute expressly permitting family members or other individuals who may have intimate knowledge of the individual's condition to request that an administra­ tor of a treatment facility file a petition. 186 leaving this language out may deter family and community involvement in ensuring treatment is provided for some­ one believed to be severely mentally ill. 187 nonetheless, the statute does not expressly say that family members or community members may not make such requests. michigan's pvot statute, titled kevin's law, 188 also became effective in 2005. 189 kevin's law, however, was integrated within the language of existing michigan mental health statutes. for instance, kevin's law expands the defini­ tion of "person requiring treatment" under the michigan mental health code, rather than drafting a separate subsection within the code (as other states have done). 190 kevin's law, nonetheless, seems to have incorporated elements of both kendra's law and laura's law but has also boiled them down into five primary criteria for eligibility. 191 reducing the criteria for treatment eligibility may lighten the state's burden slightly. nonetheless, kevin's law has retained the most difficult eligibility criteria. 192 additionally, kevin's law permits any person over the age of eighteen to bring a petition requesting that an individual 185 fla. stat. ann.§ 394.4655(3)(a)(l)-(2). 186 see kendra's law, n.y. mentalhyg. law§ 9.60(e)(i)-(ii) (mckinney2006); cal. welf. & inst. code§ 5346(b)(2)(a)-(b). 187 see supra notes 181-82 and accompanying text. 188 kevin's law was named after kevin heisinger, a twenty-four-year-old college student who was beaten to death in 2000 by a vietnam veteran with a history of schizophrenia. fritz, supra note 8, at al2. 189 see the beginning of hope: kevin's law to aid the mentally ill, treatment aovoc. ctr., mar. 30, 2005, at http://www.psychlaws.org/pressroom/rls-kevinslawlaunched.htm. 19° kevin'slaw, mich. comp.lawsann. § 330.1401(40l)(l)(d)(westsupp. 2007);see also governor granholm signs kevin's law, creates new treatment options for mentally ill, micidgan.gov, dec. 29,2004, athttp://www.michigan.gov/gov/0,1607,7-168-23442_21974107105--m 2004 12,00.html. 191 f~st, th~ presence of a mental illness must be established. second, a lack of insight that makes the individual unlikely to participate in voluntary treatment must be established. third, the individual must currently be noncompliant with treatment. fourth, forced treatment will prevent a relapse or deterioration. and, fifth, that noncompliance has been a factor in the individual's placement in a psychiatric hospital, prison, or jail at least twice within the last four years. see mich. comp. laws ann.§ 330.1401(40l)(d). 192 mich. comp. laws ann.§ 330.1401(40l)(l)(d) (requiring, in particular, that "non­ compliance with treatment has been a factor in the individual's placement in a psychiatric hospi­ tal, prison, or jail at least 2 times within the last 48 months or whose noncompliance with treatment has been a factor in the individual's committing 1 or more acts, attempts, or threats of serious violent behavior within the last 48 months."). note that both kendra's law and laura's law restrict the first prong of this test to three rather than four years. see kendra's law, n.y. mental hyg. law § 9.60(c)(4)(i)-(ii) (mckinney 2006); laura's law, cal. welf. & inst. code§ 5346(a)(4) (west supp. 2007). 398 indiana heal til law review [vol. 4:361 receive pvot. 193 this policy permits a teacher or landlord to file a petition, and may therefore facilitate pvot in the most preventive fashion, as the peti­ tioner need not wait until a police officer or mental health professional encoun­ ters the severely mentally ill individual. further, under kevin's law, like the other pvot statutes, the petition must be accompanied by a clinical certificate by a physician or an affidavit explaining why none was able to be secured. 194 finally, in 2000, the province of ontario, canada, enacted a pvot statute called brian's law.195 brian's law eliminates the prior canadian immanency requirement of dangerousness as the threshold for treatment, and now permits evidence of deteriorating and chronic condition through evidence such as prior hospitalizations. 196 similar to the american pvot statutes, brian's law allows family members and mental health professionals to file petitions on behalf of a mentally ill individual. 197 b. other jurisdictions transitioning to add pvot new mexico's house of representatives passed a bill in 2007 that may 193 mich. comp. laws ann.§ 330.1434(434xl) (west 1999). 194 mich. comp. laws ann.§ 330.1401(434x3). 195 e.g., cornwell & deeney, supra note 3, at 230-31. brian was a well known sports­ caster who was shot to death by a man diagnosed with paranoid schizophrenia who refused treatment despite the advice of his psychiatrists. e.g., david a. harris, brian 'slaw broadens criteria for treating the mentally ill, burlington post, oct 17, 2001, available at http://www.lawyers.ca/dharris/artic1eslbrianslaw.htm (last visited mar. 5, 2006). 196 e.g., gov't of ontario, canada, ministry of health and long-term care, mental health: brian's law 2 (2000), available at http://www.health.gov.on.calenglish/­ public/pub/mentallbrianslaw.html (last visited mar. 6, 2006). 197 /d. "as in the united states, this legislative initiative has proven quite controversial in canada. although critics have offered many of the same objections directed at ... [pvot], they have the added concern that canadian mental health consumers lack the same measure of constitutional protection enjoyed by their american countetparts." cornwell & deeney, supra note 11, at 231. additionally, dlinois recently passed a civil commitment statute that is similar to pvot in some key respects. rlinois gov. signs legislation to improve state's mi treatment law, mental health weekly, sept. 24, 2007, at 3. the tem3 "person subject to involuntary admission" in the existing dlinois civil commitment statute has been expanded to include a person with mental illness who, because of the nature ofhis or her illness, is un­ able to understand his or her need for treatment and who, if not treated, is rea­ sonably expected to suffer or continue to suffer mental deterioration or emotional deterioration, or both, to the point that the person is reasonably expected to engage in dangerous conduct. s.b. 234, 95th gen. assem., reg. sess. (ill. 2007) (emphasis added). while the statute still focuses on potential dangerousness as a trigger for treatment, the definition of dangerousness is now much broader and therefore is very similar to other pvot statutes. see id. (defining dan­ gerousness as ''threatening behavior or conduct that places another individual in reasonable expectation ofbeing harmed .... ") (emphasis added). 2007] toward a twenty-first century civil commitment statute 399 create a pvot statute in new mexico in the near future. 198 the proposed bill includes elements of both kendra's law and laura's law. 199 the earlier ver­ sion even proposed to take kendra's name for the bill, 200 though the current bill is titled "mandated community treatment. "201 there are seven eligibility criteria for pvot under the bill, as well as a preamble that requires the proposed treatment be the least restrictive. all but one of the criteria, the first criterion, appear similar to both kendra's law and laura's law. the first criterion of then ew mexico bill is unique in that it requires that the mentally ill individual lack capacity. capacity is defined in the bill as "a person's ability to understand and appreciate the nature and consequences of proposed mental health treatment, including significant benefits and risks and alternatives to the proposed mental health treatment, and to make and commu­ nicate an informed mental health treatment decision."202 while kendra's law and laura's law fail to expressly require a "capacity" criterion, it is arguably implicit (as "capacity" is defined by the new mexico bill) in those criteria that require the individual be unlikely to voluntarily participate in outpatient treat­ ment or unlikely to survive safely in the community without supervision. by comparison, the proposed new mexico bill retains the "unlikely to voluntarily participate" criterion but omits the "unlikely to survive safely without supervi­ sion" criterion.203 while the proposed definition of"capacity'' in the bill seems 198 h.b. 609, 48th leg., 1st sess. (n.m. 2007) (passed feb. 24, 2007). while forty-two states have some fonn of aot laws, new mexico is one of the eight states that currently has no fonn of aot. hence adoption ofpvot would be a radical shift for the new mexico mental health system as no form of outpatient treatment is otherwise available. see also treatment advoc. ctr., top policy makers support aot for new mexico, http://psychlaws.blogspot.com/2006/02/top-policymakers-support-aot-for-new.html (last visited mar. 31, 2007). the event which spurred citizens and legislators to draft a new bill to adopt pvot occurred in august 2005. see h.b. 174, 47th leg., 2d sess. (n.m. 2006). john hyde, forty-eight-years-old and diagnosed with schizophrenia and bipolar disorder, shot and killed five people in albuquerque, including two police officers who were dispatched to the scene. see id. according to his fam­ ily, for at least five months prior to the shooting, john had been off his medication. see id. even local church officials had previously called the police to have john hospitalized, but he was continually released after short periods of time, in one case, just four hours. see id. see also help mentally ill out of danger zone albuquerque j., jan. 1, 2006, at b2, segment available at http://www.psychlaws.org/stateactivity/newmexico.htrn. representative gutierrez commented that "[e]xisting new mexico law essentially forces people who lack insight into their illness to hit rock bottom before they can be helped ... [and that f]orced deterioration is cruel and inhumane." i d. 199 h.b. 609, 48th leg., §4, 1st sess. (n.m. 2007) (passed feb. 24, 2007). 200 h.b. 174, 47th leg., 2d sess. (n.m. 2006); see also cal. network of mental health clients, ab 2357-why oppose it, www.californiaclients.org/policy/ab2357.cfm [hereinafter cal. network of mental health clients, ab 2357-why oppose it] (last visited apr. 1, 2007) (stating that this version ofnew mexico bill died on the floor of the legislature). 201 h.b. 174, 47th leg., 2d sess. (n.m. 2006); h.b. 609, 48th leg., lst sess. (n.m. 2007). 202 h.b. 609, 48th leg.,§ 2b, 1st sess. (n.m. 2007) (defining capacity). 203 laura's law, cal. welf. & inst. code § 5346(a)(3) (west supp. 2007); kendra's 400 indiana health law review [vol. 4:361 narrowly tailored to target severely mentally ill individuals, it may have the ef­ fect of creating a higher standard than the legislature intended (or that pvot statutes in general are aiming toward). a more appropriate term to use for this criterion might be "insight" because capacity is generally a weightier legal term, and as generally defined it could effectively prohibit the use of pvot for a large portion of severely mentally ill individuals.204 additionally, the new mexico bill, similar to kendra's law, permits fam­ ily members, among a long list of eleven other persons, to file a petition for pvot.205 the bill further proposes that ''the director of a public or charitable organization ... where the respondent resides or provides mental health ser­ vices" also be permitted to file the petition?06 this expands the scope of per­ sons permitted to file a petition for pvot compared to kendra's law. tennessee's general assembly introduced a pvot bill in 2007.207 the bill is virtually identical to kendra's law. 208 it includes the same pvot eligi­ bility criteria as well as the classes of persons permitted to file a petition to seek a pvot order on behalf of a third party. 209 similarly, ohio introduced a pvot bill in 2007 that is nearly identical to kendra's law.210 though the proposed bill alters some terms, the core substance of the bill is the same. 211 new jerseyproposedapvotbillin2006namedgregory'slaw. 212 the bill that was passed by the senate six months later, however, omitted the origi­ nally proposed pvot language.213 thus, the bill currently passed by the senate and awaiting confirmation by the assembly is a general aot statute rather than a pvot statute. new jersey, like new mexico, currently has no form of aot whatsoever, and therefore the need for aot, in any form, is great.214 the original bill introduced in the senate, however, was modeled after kendra's law, n.y. mental hyg. law§ 9.60(cx3) (mckinney 2006). 204 see supra part lli.c. 205 h.b. 609, 48th leg., §5, 1st sess. (n.m. 2007) (passed feb. 24, 2007). 206 h.b. 609, 48th leg., §5(ax6}, 1st sess. (n.m. 2007) (passed feb. 24, 2007). 2m h.b. 1883, 105th gen. assem. (tenn. 2007) (introduced feb. 8, 2007). 208 see id 209 id § (c)(1)-(7}, (e). 210 h.b. 299, 127th gen. assem., reg., sess. (ohio 2007) (introduced aug. 21, 2007). 211 see id for example, instead oflisting all the various medical professionals who may file a petition under that section of the statute, see n.y. mental hyg. law§ 9.60(e)(i)-(viii) (mckinney 2006), the proposed ohio bill defines "mental health professional" in much the same manner in the definitions section of the statute. h.b. 299, 127th gen. assem., reg., sess. (ohio 2007). 212 s.b. 1093, § 2m(2), 212th leg. (nj. 2006) (introduced jan. 26, 2006). the new jersey assembly also introduced a nearly identical bill during the same month that never made it out of committee. ab. 367, 212th leg. (n.j. 2006) (introduced jan. 10, 2006). 213 s.b. 1093, §2m, 212th leg. (n.j. 2006) (substituted june 15, 2006) (passed june 22, 2006 and sent to the assembly). 214 see press release, treatment advoc. ctr., governor's task force on mental health recommends aot for new jersey (mar. 31, 2005), available at http://www.psychlaws.org/­ pressroom/rls-njtaskforce.htm. 2007] toward a twenty -first century civil commitment statute 401 law. 215 it provided five criteria for treatment eligibility similar to both kendra's law and laura's law.216 additionally, gregory's law would have permitted any individual to petition the court for a pvot order on behalf of a severely mentally individual by submitting two clinical certificates, one from a psychia­ trist, to the court.217 while it appears that gregory's law did not survive the senate chambers as originally proposed, gregory's law shows yet another ju­ risdiction whose legislature has considered adopting a pvot statute, though in this instance, and at the current time, it appears new jersey has decided against its adoption. vll. constitutional analysis of pvot statutes while the previous sections have highlighted a variety of policy positions at work in pvot statutes, assessing the constitutionality ofpvot statutes is critical in order to better anticipate the constitutional strength ofpvot statutes in years ahead. the constitutional status ofpvot statutes has not reached the united states supreme court. 218 nonetheless, the highest court in new york upheld the constitutionality of kendra's law in in re k.l. 219 in in re k.l. the court held that kendra's law was narrowly tailored to achieve state goals, and that new york had a compelling interest under state la~0 to order pvot un­ der both its police and parens patriae powers.221 the court thus upheld 215 see s.b. 1093, 212th leg. (n.j. 2006)(introduced jan. 26, 2006). gregory's law was named after eleven-year-old gregory katsnelson who was stabbed to death in october 2002 while riding his bicycle near his home by twenty-six-year-old ronald pituch who had just beaten his own mother to death with a barbell because she had refused to buy him cigarettes. ld pituch had a lengthy history of treatment for schizophrenia but denied that he was mentally ill and refused to take medication. !d. members ofpituch's family had attempted to get him forced treatment but were unable to have him civilly committed without his consent and due to the high evidentiary threshold in the danger statutes. see id 216 s.b. 1093, 212th leg. (n.j. 2006) (introduced jan. 26, 2006). 217 s.b. i 093, § 2m, 212th leg. (n.j. 2006) (substituted june 15, 2006) (passed june 22, 2006 and sentto the assembly); see also a.b. 367, 212th leg. (n.j. 2006) (introduced jan. 10, 2006). 218 for arguments that pvot is constitutional see generally cornwell & deeney, supra note 3, at 219-25, and watnik, infra note 222, at 1208. for arguments that pvot is unconstitu­ tional see generally gutterman, supra note 10, at 2403, 2439-44, campbell, infra note 238, at 175, 185-99, and o'cormor, supra note 3, at 339-58. each of these law review articles (the latter three were comments or notes) was published between 2000 and 2003. 219 in re k.l., 806 n.e.2d 480, 486, 487 (n.y. 2004). 220 new york applies a higher level of scrutiny-requiring a "compelling" interest-than that which would be applied by the federal courts. see infra notes 230-33 and accompanying text. 221 there are two sources of power from which states may enact civil commitment stat­ utes. see u.s. const. amend. x. first is each state's police power. see, e.g., hortas, supra note 11, at 164. this is the power of each state to protect the health, safety, and welfare of its citizens. see, e.g., id. second is each state's parens patriae power. e.g., id. parens patriae means "parent of the country." e.g., gutterman, supra note 10, at 2428 (quoting barbara a. 402 indiana health law review [vol. 4:361 kendra's law on substantive and procedural222 due process grounds.223 weiner & robert m. wettstein, legal issues in mental healrn care 47 (1993)). this power allows the state to step in as a paternal figure to care for an individual who typically lacks a certain level of capacity or competency. reisner, slobogin & raj, suprdnote 176, at 712-16. generally, most aot statutes are a simultaneous exercise of both police and parens patriae powers. pvot statutes, like the danger-or-grave-disability statutes, are an exercise of both police and parens patriae powers. pvot statutes seek to prevent harm and danger to the public or the individual even though based on more probabilistic tendencies towards violence than the danger statutes. hence, pvot may be a more vivid exercise of the parens patriae powers in comparison to the danger statutes because of the focus on effectively treating and rehabilitating the individual far sooner than the actual occurrence or "immanency" of harm. 222 in re k.l., 806 n.e.2d 480,487 (n.y. 2004). ultimately, procedural due process is determined by judicial balancing based on the particular process given under any pvot or aot statute. therefore the precise outcome of any particular pvot statute on this issue will always depend on the particular procedure the statute provides for. in the instant case, k.l. argued that kendra's law violated procedural due process by failing to provide notice and a hearing prior to his temporary removal to a hospital for failure to comply with the pvot order. see in re k.l., 806 n.e.2d at 486. the court rejected this argu­ ment, again focusing on the state's "quite strong" interest in removing from the streets persons who as a result of noncompliance are at risk of relapse or deterioration likely to result in harm to themselves or others. id at 487. the court noted that a physician is still required to re-examine the patient to determine whether hospitalization is necessary upon failure to comply with pvot. /d. the court also stated that a pre-removal judicial hearing during the middle of court-ordered pvot would significantly reduce the speed with which the patient can be evaluated and poten­ tially begin to receive needed treatment if a physician has reason to believe it is needed. id while there is no strict formula for determining whether procedural due process has been met by a particular pvot statute, the united states supreme court in mathews v. eldridge articulated a balancing test, which requires that procedural protections reflect the level of in­ fringement on the claimant's interests. mathews v. eldridge, 424 u.s. 319, 334-35 (1976). see also ilissa l. watnik, comment, a constitutional analysis of kendra's law: new york's solu­ tion for treatment of the chronically mentally ill, 149 u. p a. l. rev. 1181, 1209 (200 1) (dis­ cussing the application of the mathews balancing test to procedural claims against pvot statutes). "consistent with the sliding scale approach of the matthews [sic] balancing test, all states have granted fewer procedural protections to outpatients than to inpatients, due to the lower restriction on liberty involved in outpatient treatment." /d. at 1208. hence, procedural processes for pvot and aot might not need to be as stringent as those for hospitalization, since more freedoms are taken when someone is physically confined. nonetheless, some would argue that forcibly medicating someont>-that is altering their mental state--even if in an outpa­ tient setting, is more violative of liberty interests than being physically confined. saks, refusing care, supra note 18, at 87. yet medication has become one of the best tools for treating the severely mentally ill. therefore, analyzing procedural due process claims under pvot and aot statutes in terms ofliteral physical barriers or h"berty interests may no longer be the best way to evaluate whether due process has been satisfied. nonetheless, legal academics have identified several critical constitutional minimums for civil commitment procedures: 1) legal representation at all stages of the hearing, 2) testi­ mony from the examining physician at the hearing stating the rationale for the recommended treatment, 3) availability of the physician and other adverse witnesses for cross-examination, and 4) notice of the hearing served to the subject of the petition. see watnik, supra note 222, at 1209, 1227 (discussing the procedural due process concerns under kendra's law but conclud­ ing it is likely a constitutional exercise of state power). these procedural prerequisites are ad2007] toward a twenty-first century civil commitment statute 403 in in re k.l., k.l. was diagnosed with schizoaffective disordd24 and also had a history of noncompliance with treatment and psychiatric hospitaliza­ tion. 225 k.l. raised several arguments regarding the constitutionality of kendra's law, under which he had been involuntarily court-ordered to receive psychiatric treatment, including attending case management meetings, submit­ ting to regular blood testing, attending individual therapy sessions, and self­ administering the antipsychotic zyprexa. 226 in holding for the state and permit­ ting pvot under kendra's law to be administered, 227 the new york court emdressed by the current pvot statutes. protection of constitutional rights and liberties were clearly in mind when pvot statutes were drafted. kendra's law, ch. 408, 1999 n.y. laws 2870,2874-75 (codified at n.y. mentalhyg. law§ 9.60) (describingtherightto counsel and various levels ofhearings); assisted outpatient treatment demonstration project act of2002 ("laura's law"), ch. 1017, 2002 cal. legis. serv. 5046 (west) (codified at cal. welf. & inst. code§§ 5345-5349.1) (''this bill would specify ... various rights of the person who is the subject of the petition, and hearing procedures."). see also kendra's law, n.y. mentalhyg. law § 9 .60(m), (n) (mckinney 2006) (specifying, for example, a maximum seventy-two-hour­ hold for a hospital psychiatric exam, if none other is able to be obtained). ultimately, whether any particular state pvot statute meets procedural constitutional standards will depend on the specific language of each state's pvot statute. 223 in re k.l., 806 n.e.2d 480, 486 (n.y. 2004). 224 schizoaffective disorder is a subtype of schizophrenia that includes significant symp­ toms of mood disturbances. see am. psychiatric ass'n, dsm-iv-tr, supra note 4 7, at 159. k.l. had a diagnosis ofschizoaffective with bipolar type. in re kl., 806 n.e.2d at 482. 225 in re k.l., 806 n.e.2d at 482. 226 id 227 id at 486. k.l. argued that kendra's law violated substantive due process because it lacked a determination of incapacity before permitting forced medication or treatment against the patient's will. id. at483-84. lnriversv. katz,495n.e.2d337 (n.y.1986), the new york court of appeals held that where the state does not have a police power interest in forcing medication but merely a parens patriae power interest, mentally ill patients who are competent have a constitutional right to refuse medication. /d. at 343-44. therefore a finding of incapacity is required under new york law in situations in which only the parens patriae power is impli­ cated to permit forced medication. id in rivers, at issue was the forced medication of several severely mentally ill persons in an inpatient facility in which the court determined the police powers were no longer implicated. id. at 339, 343-44. the court inln re k.l. rejected the inca­ pacity argument by distinguishing the case from rivers, stating that kendra's law "neither au­ thorizes forcible medical treatment in the first instance nor permits it as a consequence of noncompliance .... " and emphasizing that both the police powers and parens patriae powers were implicated under kendra's law, thereby eliminating the application of rivers. see in re k.l., 806 n.e.2d at 484-85. in particular, the court's statement that kendra's law does not require treatment by medication is slightly ambiguous. see id. at 484. certainly, a pvot re­ cipient may be an active part of developing the written treatment plan and ensuring it is the least restrictive treatment, however, it is not clear that there is a realistic alternative to forced medica­ tion if the court decides by clear and convincing evidence that such treatment is necessary and is the least restrictive. n.y. mental hyg. law § 9.60(i)(l )-{3), (j); see in re k.l., 806 n.e.2d at 484. further, then. y. report shows that medication adherence is an integral part to the success of kendra's law and effectively treating the severely mentally ill. see n.y. report on kendra's law, infra note 247, at 12. aside from this ambiguity regarding medication, the incapacity rule of rivers was still not binding because the police powers are an integral part of pvot. see in re k.l., 806 n.e.2d at 485. 404 indiana health law review [vol. 4:361 phasized that the "right of mentally ill persons to refuse treatment may have to yield to compelling state interests[,]'.228the findings must be made by clear and convincing evidence, and that the treatment proscribed must be the least restric­ tive alternative. 229 with respect to the right to refuse psychiatric medication, the united states supreme court has identified the existence of a right to refuse medica­ tion, but only in inpatient hospitalization and incarceration contexts?3° further, the court has been consistent in refusing to define the right as fundamental, which would require the court to apply strict scrutiny. 231 with respect to men­ tally ill individuals who are hospitalized in an inpatient setting, the court has held that mentally ill individuals have a liberty interest in avoiding the un­ wanted administration of antipsychotic drugs.232 the court has left great lee­ way to the states for striking the constitutional balance between a patient's interest to refuse medication and state's interest in medicating a patient already in a controlled hospital setting.233 with respect to mentally ill individuals in the prison setting, the court has applied two differing standards of review to two different groups of imprisoned individuals: 1) those held in jail awaiting or during trial and 2) those already convicted and sent to prison. in the former instance, the court has applied mid­ level scrutiny,234 holding that the state must make a "finding that might support a conclusion that administration of antipsychotic medication was necessary to accomplish an essential state policy .... "235 in the latter instance, concerning an inmate convicted of a crime, the court has held that the state's interest in medicating an inmate against his will must be merely reasonably related to a legitimate penal objective.236 the shifting standards of review the court has articulated with respect to the right to refuse medication thus far depend on the setting in which the medi­ cation is sought to be administered. critically, the standard of review depends on the strength of the liberty interest in the particular setting in which medica228 in re k.l., 806 n.e.2d at 485 (applying a state level of scrutiny). 229 /d. at 486. 230 see washington v. harper, 494 u.s. 210, 222-23, 229 (1990) (prison); mills v. rogers, 457 u.s. 291,299 (1982) (hospitalization). 231 see rogers, 457 u.s. at 303 (emphasizing that states may recognize broader liberty interests than those protected by the constitution). 232 see rogers, 457 u.s. at 299 (assuming that the "constitution recognizes a liberty interest in avoiding the unwanted administration of antipsychotic drugs" in the hospital context). 233 rogers, 457 u.s. at 300 (emphasizing that the state law in this instance, which ap­ peared to require an "overwhelming state interest" to forcibly medicate, was broader than those rights protected by the federal constitution); gutterman, supra note 10, at 2418. 234 see riggins v. nevada, 504 u.s. 127, 136 (1992) (o'connor, j.) ("contrary to the dissent's understanding, we do not 'adopt a standard of strict scrutiny."'). 235 riggins, 504 u.s. at 138 (emphasis added). 236 washington v. harper, 494 u.s. 210,226 (1990) ("[the prison policy] is a rational means of furthering the state's legitimate objectives."). 2007] toward a twenty-first century civil commitment statute 405 tion is administered. the setting in which pvot is administered is on an out­ patient basis, but after a determination has been made that the individual meets pvot criteria and is severely mentally ill. therefore, this setting appears to be more analogous to the individual hospitalized or convicted of a crime than the individual awaiting trial in jail. this is because a determination that the indi­ vidual is severely mentally ill has already been made, unlike the setting in which an individual, irrespective of mental illness, is presumed innocent and is waiting to be tried for a crime. 237 some scholars argue that the standard of review in an outpatient setting should be at least as great, and possibly greater, than the standard of review for those in a hospital or prison setting. 238 but it could also be argued, to the con­ trary, that severely mentally ill individuals neither hospitalized nor incarcerated pose a higher rislc39 to the public on the streets than when confined to the hos­ pital or prison setting. under this line of reasoning, after the state has proven by clear and convincing evidence that the individual is severely mentally ill and in need ofpvot, the level of scrutiny might be reduced rather than enhanced. in such an instance, akin to the standard of review of an individual who is hos­ pitalized for his or her severe mental illness, the burden of proof would be on the severely mentally ill individual to prove that pvot was not reasonably re­ lated to a legitimate state interest. additionally, legislative findings directly support that pvot statutes seek to prevent inpatient hospitalization and incarceration, and in a sense replace these treatment avenues. therefore, it is unclear as to why the standard of re­ view· would be higher for pvot statutes in the outpatient setting. further, since the right to refuse medication is not a "fundamental right" (when mental health is at issue i 40 strict scrutiny is not likely to be applied, and therefore, the government would only need to show a substantial (rather than compelling) or rational interest for the state to administer pvot that is narrowly tailored to some degree. in sum, the precise standard of review to be applied to the right to refuse medication is in a pvot setting is unclear, although it is likely to be somewhat deferential to the pvot statute.241 equal protection arguments are also often raised in challenges to involun­ tary treatment under state civil commitment statutes. the more interesting equal protection argument arises between different classes of mentally ill per237 in riggins, the defendant's mental health only became an issue after he was taken into custody. riggins, 504 u.s. at 129. 238 see kristina m. campbell, note, blurring the lines of the danger zone: the impact of kendra's law on the rights of the nonviolent mentally ill, 16 notre dame j. l. ennes & pub. pol'y 173, 186-87 (2002). 239 see supra part m.d (discussing the relation between violence and severe mental ill­ ness). 240 see, e.g., washington v. harper, 494 u.s. at 223, 229; mills v. rogers, 457 u.s. 291, 299-300 (1982). 241 see, e.g., washington v. harper, 494 u.s. at 223; rogers, 451 u.s. at 299-300. 406 indiana health law review [vol. 4:361 sons. for example, severely mentally ill persons subject to pvot are arguably treated differently than those subject to inpatient treatment. there may be a persuasive justification, however, for the different classifications and treatments permitted under law. 242 for instance, hospitalized mentally ill individuals have often met requisite dangerousness criteria, whereas individuals subject to pvot and aot might not always rise to the level of dangerousness. yet the court has continued to apply the rational review standard (or minimum scru­ tinyf43 to mentally ill individuals in equal protection cases and has not ex­ pressly applied either strict or mid-level scrutiny. for example, in city of cleburne v. cleburne living cente?44 the court refused to formally apply a heightened standard of scrutiny to the developmentally disabled, even though the ordinance discriminating against such persons was ultimately invalidated under an unusually rigorous minimum scrutiny examination.245 because mini­ mum scrutiny is likely to be applied to different classifications of severely men­ tally ill persons, such challenges to statutes regarding these classifications will likely not prevail. 246 this is because there are often legitimate (if not compel­ ling or substantial) reasons why individuals with relevantly different mental illness should receive differing forms of psychiatric treatment. though pvot has not yet reached the united states supreme court, in re k.l. is not the first constitutional attack on kendra's law in new york to be rejected. kendra's law has repeatedly been upheld as a constitutional exercise of state power in new york's lower courts.z47 nonetheless, in re k.l. is the first case that challenged the constitutionality of kendra's law to reach the new york court of appeals.z48 as one academic stated: with its decision in in re k.l[.], the court has made it abundantly clear that kendra's law passes constitutional 242 see cornwell & deeney, supra note 3, at 221. 243 in general rational review requires that the statute be rationally related to a legitimate state interest. e.g., city of cleburne v. cleburne living ctr., 473 u.s. 432,440 (1985). 244 city of cleburne, 473 u.s. at 432. 245 id. at 442, 448-450. 246 id. at 442; watnik, supra note 222, at 1211-12. 247 e.g., in re urcuyo, 714 n.y.s.2d 862, 869, 873 (n.y. sup. ct. 2000) (rejecting re­ spondent's arguments that kendra's law violated due process and equal protection under both new york's constitution and the u.s. constitution because a judicial finding of incapacity was not a criteria for treatment eligibility). n.y. state 0fficeofmentalhealtii, kendra's law: final report on tife statijs of assisted outpatient 'frea1ment app.2 at 35-53 (2005), available at http:/ /www.omh.state.ny.us/omhweb/kendra _ web/finalreportjpvotfinal2005.pdf (last visited mar. 31, 2007) [hereinafter n.y. report on kendra's law] (detailing the consti­ tutional challenges to kendra's law). but see perlin, supra note 3, at 200-02 (discussing the right to refuse medication). 248 n.y.reportonkendra'slaw,supranote247,at39. seea/sopauls.appelbaum, assessing kendra's law: five years of outpatient commitment in new york, 565 psychiatric servs. 791, 791 (2005). 2007] toward a twenty -first century civil commitment statute 407 muster. given its demonstrated effectiveness in improv­ ing outpatient outcomes for mentally ill patients and promoting public safety, there is little question that kendra's law will continue to be utilized to ensure pub­ lic safety and patient health when mentally ill patients return to the community. 249 in matter ofk.l. signals to other state and federal courts that pvot statutes are likely to be constitutional in structure and practice. 250 viii. reports and data on the effects of pvot statutes the most recent report on pvot was published in march 2005, was au­ thored by the new york state office of mental health, and is titled "kendra's law: final report on the status of assisted outpatient treatment" ("n.y. re­ port"). 251 then. y. report was statutorily required pursuant to the enactment of kendra's law.252 several other research studies have been conducted to evaluate other types of aot and ot laws that provide for conditional release, hospital diversion, or some variation ofpvot.253 but since these earlier stud­ ies were conducted prior to the specific pvot statutes that this note addresses, it is not clear how much weight should be placed on them.254 for instance, 249 edward f. mcardle, 2003-2004 survey of new york law: health law, 55 syracuse l. rev. 1107, 1141 (2005). see also emily s. huggins, note, assisted outpatient treatment: an unconstitutional invasion of protected rights or a necessary government safeguard?, 30 j. legis. 305, 316-17 (2004) (concluding that in re kl. suggests that future challenges to the constitutionality of kendra's law will be struck down). 250 see in re k.l., 806 n.e.2d 480, 486, 487 (n.y. 2004). 251 n.y. state 0mce of mental healtii. kendra's law: final report on 1he statusofassistedouipatient'freatment(2005),availah/eathttp://www.omh.state.ny.us/­ ombweb/k.endra _ web/finalreportjpv01final2005.pdf(last visited mar. 31, 2007) [hereinafter n.y. report on kendra's law]. 252 n.y. rep0rtonkendra'slaw,supranote251, at i. 253 the new york involuntary outpatient commitment pilot program (also known as the bellevue pilot project) also studied aot laws :from 1995 to 1998 just prior to the adoption of kendra's law in 1999 but interestingly found no statistical evidence supporting the effective­ ness ofpvot. o'connor, supra note 3, at 326-27; see also honig & stefan, supra note 3, at 111, 114-15. 254 for the most part, these prior studies found that assisted outpatient treatment works. see honig & stefan, supra note 3, at 109; o'connor, supra note 3, at 360 & n.228. a 2001 meta-analysis study (of several other aot studies) by rand suggested that both the duke study and new york pilot study were flawed. honig & stefan, supra note 3, at 114 & 21. rand is a non-profit research organization that reevaluates scientific studies for the purpose of identifying errors in data collection and conclusions. see generally rand corporation, objec­ tive analysis: effective conclusions, http://www.rand.org (last visited feb. 20, 2006). the name rand was derived :from a merging of the terms research and development. i d. rand's meta-analysis concluded that aot was not effective in reducing hospitalization rates, as was suggested by both studies rand reviewed. see honig & stefan, supra note 3, at 114. the 408 indiana health law review [vol. 4:361 some of the earliest pvot statutes, such as that ofnorth carolina, are similar to the specific statutes that this note addresses, but over the last couple of dec­ ades have been updated procedurally and substantively. hence, the n.y. re­ port contains the most valuable and current research data concerning the effectiveness ofpvot statutes. then. y. report documents the empirical findings since the implementa­ tion of kendra's law in 1999, covering just over a five year period. the find­ ings are derivative of three sources. first, an electronic tracking system was used in each county to compile basic information concerning each recipient's gender, illness, age, and court order?55 second, paper-based surveys were used by case managers to collect data concerning the progress of recipients.256 spe­ cifically, case managers were expected to keep assessments for each recipient at the critical intervals of treatment: 1) at the onset of the court order, 2) at the end of the initial court order, and 3) if the court order was renewed, then every six months for the duration of the order.257 third, face-to-face interviews con­ ducted by researchers and office staff were conducted with a sample ofpvot recipients in new york city.258 overall, the n.y. report documents the widespread success ofkendra's law throughout the state ofnew york, noting that recipients ofpvot "are able to make gains in their recovery process and maintain them over the dura­ tion of ... participation and beyond.'.259 as a result of these positive findings, the new york legislature deleted the initial2005 sunset date of kendra's law and extended it to 2010.260 the new york: office of mental health had previ­ ously recommended, based on then. y. report alone, that the new york legis­ lature delete the sunset provision indefinitely and extend kendra's law permanently. 261 in re-enacting another sunset provision to kendra's law, how­ ever, the legislature appears most interested in obtaining more data concerning kendra's law before making any more permanent amendments. this bolsters the argument more generally that states considering adopting pvot should do so sooner rather than later in order to help further the data being compiled con­ cerning the potential effectiveness or ineffectiveness ofpvot. specific findings of the rand analysis, however, may actually support the development of the recent pvot statutes this note addresses since they tend to require better monitoring of pa­ tients, which was one of the critiques of aot. cf. honig & stefan, supra note 3, at 117. 255 n.y. reportonkendra'slaw,supranote 251, at7. 256 id 257 id 258 id 259 /d. at 22. 260 kendra's law, ch. 158,2005 n.y. laws 2740(codified at n.y. mentalhyo.law § 9.60 (mckinney 2006)) (stating that 2010 is the controlling sunset date unless amended or de­ leted prior to that date). 261 n.y. report on kendra's law, supra note 251, at 22. 2007] toward a twenty-flrstcenturycivilcommitmentstatute 409 a. what types of severely mentally rl persons-and how many-are be­ ing treated under pvot? the n.y. report shows that pvot recipients suffer from the most severe and debilitating axis i mental illnesses. seventy-one percent ofpvot recipi­ ents under kendra's law had a diagnosis of schizophrenia, and thirteen percent had a diagnosis ofbipolar disorder. 262 one study critiquing the effectiveness of general aot laws concluded that aot statutes could reduce readmissions only if they were "imposed upon individuals with psychotic-as opposed to affec­ tive-disorders."263 the n.y. report supports this finding because almost three quarters of pvot recipients had a diagnosis of the psychotic disorder schizophrenia. further, recent research suggests that bipolar and depression may have psychotic or positive symptoms. 264 therefore we might assume that the percentage ofpvot recipients who have a primary diagnosis of an affec­ tive disorder, such as bipolar or depression, suffer from the most severe forms of these disorders, which might include psychotic symptoms. 265 in terms of the sheer number of individuals receiving treatment through pvot, less than half of the individuals who were referred to the n.y. mental health director for pvot received a court order obligating them to enter treatment 266 in total, 10,078 individuals were referred to determine potential eligibility for a court order (between 1999 and 2004). 267 petitions were filed to the court, however, for only 4,041 out of the 10,078 individuals referred, roughly forty percent of all persons referred.268 of the petitions filed, court or­ ders were issued for 3, 766 individuals or thirty-seven percent of all persons re­ ferred or ninety-three percent of all individuals for whom petitions wereflled.269 while ninety-three percent of individuals for whom petitions were filed re­ ceived a pvot court order, it should be kept in perspective that sixty percent of the individuals initially referred to the director never reached the court door.270 262 !d. at 9. "an estimated 4.5 million americans today suffer from the severest fonns of brain disorders, schizophrenia and manic-depressive illness (2.2 million people suffer from schizophrenia and 2.3 million suffer from bipolar disorder)." treatment advoc. ctr., home­ lessness, incarceration, episodes ofviolence: way oflife for almost half of americans with untreated severe mental illness, http://www.psychlaws.org/generalresources/fact2.htm (last visited mar. 31, 2007). 263 honig & stefan, supra note 3, at 114 (two other criteria were mentioned). 264 see supra notes 58-59 and accompanying text. 265 in addition, fifty-two percent of all pvot recipients had a diagnosis of concurrent substance abuse problems, which is often a mechanism for self-medicating a severe mental ill­ ness. n.y. report on kendra's law, supra note 251, at 9. 266 see id at 7. 267 id. 268 id. 269 see id. 270 see id. additionally, it should be noted that the mean age of recipients was thirty­ seven-and-a-half years. !d. at 9. the majority of recipients, sixty-six percent, were men, and 410 indiana health law review [vol. 4:361 the fact that pvot is being ordered for less than half of all petitions filed to the director of mental health is the kind of evidence that suggests kendra's law is targeting a specific population of severely mentally ill individuals and is also narrowly tailored to achieve those goals.271 b. how long are pvot treatment orders lasting: are patients complying with their medication and treatment plans under pvot? initial pvot court orders under kendra's law are generally six months in duration. "court orders, however, can be renewed and recipients may receive additional court orders after previous orders expire.'.272 of the 3,766 individu­ als that received treatment in new york during the five year period, roughly one-third were treated for the duration of six months. 273 just over two-thirds of the 3, 766 individuals, however, had their court orders renewed beyond the ini­ tial six months.274 the average treatment period for all3,766 recipients was one year and four months. 275 one of the critiques ofpvot statutes is that ot fails in the long-term be­ cause after initial treatments take place, mental health centers fail to follow up with recipients, and eventually lose track ofpatients.276 in undertaking a review of a key ot study, one group of prominent researchers determined that ot "could reduce readmissions and total hospital days, but only if court orders were sustained for more than 180 days [and] was combined with intensive treatment .... "277 pvot addresses these two concerns directly. first, pvot statutes pennit renewal of treatment orders after the initial six month period, or roughly 180 days;278 in fact, the n.y. report found that the average treatment period was one year and four months, far beyond the six month period. 279 second, pvot provides intensive treatment programs. 280 seventy-five percent of all recipients were single and had never been married. /d. 271 one might argue to the contrary, however, that most of the screening is being done at the office ofmental health and the courts appear to be granting most of the petitions-ninety­ three percent of those received. but it is certainly possible that the office of mental health is doing most of the screening and therefore that petitions are only being filed for those individuals the office genuinely believes meet the criteria for pvot. 272 n.y. report on kendra's law, supra note 251, at 8; kendra's law, n.y. mental hyg. law § 9.60(k) (mckinney 2006); laura's law, cal. welf. & inst. code § 5346(g) (west supp. 2007). 273 seen .y. report on kendra's law, supra note 251, at 8 (reporting thirty-six percent were treated for six months). 274 /d. (stating sixty-fo.ur percent were treated longer than six months). 275 /d. 276 see honig & stefan, supra note 3, at 114 (discussing rand's meta-analysis of aot statutes and the need for "intensive" treatment). 277 /d. (emphasis added). 278 kendra's law, n.y. mentalhyg. law§ 9.60(j)(2)(mckinney2006); laura's law, cal. welf. & inst. code § 5346(d)(5)(b) (west supp. 2007). 279 see n.y. report on kendra's law, supra note 251, at 8. 280 n.y.mentalhyg.law§9.60(a);cal. welf.&inst.code§ 5348. see also n.y. 2007) toward a twenty-f'jrstcenturycivilcommitmentstatute 411 unlike conditional release or hospital diversion laws, pvot specifically moni­ tors patients through a variety of mechanisms:· case management programs, group and individual therapy, vocational planning, and also administering tests to ensure patients are adhering to their medication.281 hence, pvot has proven to be intensive, collaborative, and reliable.282 the n.y. report's general finding that patients were adhering to treat­ ment on average for just over a year is powerful data for pvot because it re­ veals that kendra's law is maintaining treatment regimens that are structured enough to keep recipients complying with treatment. 283 the statistics proving patient adherence to treatment plans, which for the majority of patients spanned longer than one year, suggest that pvot has the power to dramatically change and enhance the lives of severely and chronically mentally ill individuals.284 in turn, the general public is better protected from future harms that might have otherwise resulted from a mentally ill individual's failure to comply with his or her treatment. 285 additionally, for the 3, 766 pvot recipients in new york, adherence to medication doubled after six months oftrea1ment, in comparison to prior adher­ ence at the onset of pvot. 286 at the onset, thirty-four percent of individuals reported already adhering to psychiatric medication, though presumably still having extreme difficulties with living.l87 but by the six month evaluation mark, sixty-nine percent of patients were adhering to their medication regi­ mens.288 this is a thirty-five percent increase in medication adherence after six months of intensive pvot treatment. 289 in addition to medication adherence, there was an eighty-nine percent increase in participation with case manage­ ment services, and a forty-seven percent increase with individual or group ther­ apy. 290 at the six month evaluation mark, there was also a reported twenty-two percent reduction in difficulties with social relations and a forty-four percent reduction for the incidence of harmful behaviors. 291 increases in medication adherence and reduction of overall harmful and anti-social behaviors suggest reportonkendra'slaw,supranote251, at 11 tbl.5. 281 n.y. mentalhyg. law§ 9.60(a)(l)(defining"assistedoutpatienttreatment''); cal. welf. & inst. code§ 5348. see also n.y. report on kendra's law, supra note 251, at ii tbl.5. 282 seen.y.reportonkendra'slaw,supranote251, at 11 tb1.5. 283 see id. at 11 tbl.5, 12 fig.3. see also n.y. mentalhyg. law§ 9.60(a)(l), (4) (describing the services provided under a pvot order). 284 seen.y.reportonkendra'slaw,supranote251,at 11 tbl.5. 285 see id at 16 tbl.9. 286 see id. at 11-12, 11 tbl.5, 12 fig.3 (statingthatcasemanagers' reports based on face­ to-tace interviews with the patients and urine samples were used to determine medication adher­ ence). 287 jd. at 12. 288 jd. 289 see id at 12 fig.3. 290 ld. at 11, lltb1.5. 291 jd at 14tbl.7, 16tbl.9, 17fig.4. 412 llidmnah~thlawrevmw [vol. 4:361 that during the first six months of pvot patients improved substantially.292 additionally, for those who had previously been hospitalized, there was a sev­ enty-seven percent reduction rate in hospitalization.293 additional aot research studies have raised concerns as to whether aot laws rely too heavily on medication, 294 fail to ensure patient compliance with treatment, 295 or fail to improve the quality of life of recipients. 296 these asser­ tions are each rebutted by the findings of the n.y. report. 297 furthermore, as mentioned previously, many aot studies have not undertaken the specific pro­ cedures of pvot statutes, or have done so in tandem with other branches of aot such as conditional release and diversion statutes. hence, researchers of pvot should be wary when searching for studies regarding the general effec­ tiveness ofboth aot and pvot statutes. often, without explicitly mentioning it, these studies are reaching conclusions about conditional release programs from incarceration or hospital diversion programs rather than the forms of pvot this note addresses. while pvot is a form of aot, it is also a com­ pletely new branch of civil commitment this is all the more reason that a new set of terms should be agreed upon by researchers to delineate the practices, so as not to cause further confusion in both legal and medical fields.z98 as a final point, then. y. report does not include data with respect to medication adher­ ence after the first sixth months of treatment, 299 however, other long-term im­ provements of recipients' conditions have been documented and are listed below. 292 see id at 12fig.3, 17fig.4, l 0·16. 293 jd. at 17, 18tbl.l0 & fig.s (rate based on the entire durationofpvot). 294 proponents assert that reliance on medication-based treatments encroaches on the liberties of mentally ill individuals, particularly due to serious side effects of certain psychiatric medications. for example, the fda issued a public health advisory in 2004 asking manufac­ turers of antidepressants to add warning statements concerning worsening depression or emer­ gency suicide. e.g., honig & stefim. supra note 3, at 116. nonetheless, studies of antipsychotic&, such as a lancet's 2003 meta-analysis of the new generation of antipsychotics, have found that clozapine is associated with fewer neurological side effects and higher efficacy than the older antipsychotics. id. 295 some studies have questioned whether aot is effective in monitoring patients and keeping them compliant with treatment programs. nonetheless, some of these same studies have found individuals who received extended aot orders and intensive community services had significant increased compliance with treatment see honig & stefim. supra note 3, at 117 (citing swartz et al. study). 296 these studies suggest that people subjected to aot feel coerced and that homeless­ ness, number of arrests, criminal victimization, violent behavior, and substance abuse are not different at the end of aot compared to the beginning of aot. see honig & stefan, supra note 3, at 118. 297 see n.y. report on kendra's law, supra note 251, at 10-14, 20-21. 298 see supra notes 35-39 and accompanying text (discussing various terms used to iden­ tifypvot). 299 compare with n.y. report on kendra's law, supra note 251, at 12 (stating the medication adherence during the first six months). 2007] toward a twenty-first century civil commitment statute 413 c. what are the effects of pvot on incarceration rates? for patients who had previously been incarcerated, the n.y. report documented an eighty-seven percent reduction in incarceration rates for pvot recipients. 300 further, for those who had previously been arrested, though not incarcerated prior to their court order, there was an eighty-three percent reduc­ tion in the incidence of arrests in new york. 301 these statistics suggest that new york's pvot is having a large impact on reducing the incidences of "criminalization of the mentally ill" with kendra's law in place. criminalization of the mentally ill refers to the fact that "at least sixteen percent of the total jail and prison population in the united states, or nearly 300,000 people, have a serious mental illness .... "302 the idea is that these individuals are effectively being incarcerated in the criminal system for their illnesses rather than aided with proper psychiatric treatment under a civil com­ mitment statute. the national average of persons in prison or jail the united states with a serious mental illness is, sadly, more than four times higher than the total number of mentally ill persons in state mental hospitals in the united states. 303 additionally, statistics show that the vast majority of those jail in­ mates with serious mental illnesses have been arrested for non-violent misde­ meanors such as trespassing, disorderly conduct, or alcohol and drug related charges?04 thus, on a national average, under the danger-or-grave-disability statutes, we are effectively incarcerating our non-violent severely mentally ill rather than assisting them in receiving necessary treatment for their illnesses. 300 !d. at 18tbl.10 & fig.5. for patients who continued with pvot after the first six months, reduction in harmful behaviors dropped to fifty-eight percent. !d. at 20 fig.8. 301 !d. at 18tbl.l 0 & fig.5. 302 treatment advoc. ctr., criminalization of americans with severe mental illnesses, at i, available at http:/ /www.psychlaws.org/generalresources/fact3.pdf(last visited mar. 5, 2006) [hereinafter treatment advoc. ctr., criminalization of severe mental illnesses] (citing 1999 u.s. dep't of justice report) (emphasis added). 303 !d. 304 !d. at 2. see also pete earley, crazy: a father's search through america's mental health madness 52, 119 (2006) (non-fiction book exploring the criminalization of the mentally ill in the miami area and at the miami-dade prison). "gilbert," whom earley met on the psychiatric wing of the miami-dade prison, had been arrested twenty times in the past six years for trespassing, panhandling, and defecating in public. !d. at 52. in los angeles county, two-thirds of inmates who were reported to have mental illnesses had been incarcerated for non­ violent crimes. steve lopez, mentally ill in the jail? it's a crime, l.a. times, dec. 11, 2005, at b 1. "the jailhouse, in fact--despite the horrors and staffing problems-is one of the few places where mental health care is available. " !d. at b 13. severely mentally ill persons who are arrested for traditional felony crimes, however, may have been led to do so due to a psychotic outbreak. wegkamp, supra note 116, at 32, 38 (describing the true story of his then twenty­ year-old son chad who robbed a bank to raise adequate funds because he believed he needed a medical surgery to eliminate emerging voices in his head); earley, supra note 304, at 20-21 (describing the story of his severely mentally ill son, a recent college graduate, who broke into a residential home but instead of stealing items ended up taking a bubble bath). 414 indiana health law review [vol. 4:361 without pvot, this population of severely mentally ill individuals will notre­ ceive involuntary treatment because they fail to meet the imminent or substan­ tial risk tests of the danger-or-grave-disability statutes. jail or prison, even for a short period, is often a lethal setting for an indi­ vidual with a mental illness for several reasons. 30s first, mentally ill individuals are often victims of violence and abuse in prison due to their mental weak­ nesses and susceptibilities. 306 second, suicide by inmates with schizophrenia or manic-depressive illness in jails is more common than suicide among those without mental illnesses. 307 third, illogical thinking, delusions, auditory hallu­ cinations, and severe moods swings often lead to bizarre behavior by severely mentally ill persons in jails and prisons, making them more susceptible to soli­ tary confinement or breaking prison rules and receiving additional punish­ ment. 308 fourth, there is often a lack of psychiatrists to treat the prison inmates since prison is not first-and-foremost considered a mental health treatment facil­ ity. 309 fifth, jail and prison formularies often are unable to accommodate cer305 see torrey, 0utoftheshaoows,supranote74, at31-35 (1997) ("being in jail or prison when your brain is playing tricks on you is often brutal."). 306 due to a shortage of space in los angeles county jails, on november 16, 2005, thirty-five year old mentally ill shane cochran was placed in a group jail setting and was beaten to death after being tortured. lopez, supra note 304, at b i. " 'he was a fish out of water ... these inmates were sharks, and he was in the shark tank.'" /d. (quoting l.a. county sheriff lee baca). see generally earley, supra note 304, at passim (providing a vivid glimpse into the lives of the severely mentally ill who are incarcerated). severely mentally ill prisoners also may be preyed upon for information related to their charges in order to get other prisoners' sentences reduced. e.g., wegkamp, supra note 116, at 134 (descnoing how chad told an older inmate about the robbery he committed while in jail and the inmate handed the information over to the prosecutor). 307 a studyofnewyork state jails between 1977 and 1982 reported thathalfofall in­ mates who committed suicide had previously been psychiatrically hospitalized. treatment ad­ voc. ctr., criminalization of severe mental dlnesses, supra note 302, at 2. a recent federal lawsuit against the indiana prison system, which ended in a beneficial settlement for severely mentally ill prisoners, alleged that "years of isolation in [7-foot-by-12-foot] windowless cells led four mentally ill inmates to kill themselves since 2000 and others to attempt suicide, hallucinate or rip chunks of flesh from their bodies." brendan o'shaugbnessy, cells will open for isolated inmates: mentally ill prisoners have been confined 23 hours a day, but that will change, indianapous star. june 2, 2006, at al; jon murray, prison pact a win for mentally ill; deal limiting use of maximum-security cells is a good .first step, advocates say, indianapolis star, feb. 5, 2007, at bl. see also earley, supra note 304, at 296 (telling the true story of "weaver," a severely mentally ill individual who dove head-first off his bunk in prison­ presumably to commit suicide-and survived as a quadriplegic). 308 treatment advoc. ctr., criminalization of severe mental illnesses, supra note 302, at 3; william kanapaux, guilty of mental illness, psycidatric times, jan. 2004, at http://www.psychiatrictimes.com/p040101a.html. seealsoearley,supranote304,at46,24042 (describing the tragic account of several uneducated prison guards at the miami-dade county jail psychiatric floor who beat a mentally ill individual due to their fear of severely mentally prisoners more generally, which was expressed by one of the guards in the following words:" '[with] crazy inmates ... if you don't scare them, then they will hurt you"'). 309 earley, supra note 304, at 57 (documenting a prison psychiatrist who makes the 2007] toward a twenty -first century cnil commitment statute 415 tain prescriptions inmates may already be receiving outside of prison. there­ fore, mentally ill prisoners are often switched to older and cheaper drugs that may have increased side effects and be less effective than other prescription drugs; 310 sixth, inmates are typically prohibited from speaking or visiting with family or friends, except at rare and designated visiting hours.311 seventh, the physical design of incarceration-a system designed to punish and deter­ further antagonizes the development and deterioration of mental illness gener­ ally.312 yet despite all these reasons, the severely mentally ill more often wind up being "treated" in prison or jail rather than through the civil system. pvot statutes aim to alleviate criminalization of the mentally ill. they seek to rehabilitate such individuals rather than incarcerate them, ultimately reducing costs in prison settings as well. the n.y. report illustrates how kendra's law is seeking to eliminate the number of severely mentally ill per­ sons who are incarcerated due to their illness. 313 d. what are the effects of pvot on rates of homelessness? the n.y. report showed a seventy-four percent reduction in the inci­ dence of homelessness beyond the six month treatment period for those who reported being homeless at the beginning ofpvot.314 these statistics reveal that pvot has the capacity to bring a halt to, what some have termed, the re­ volving-door phenomenon at work in the failures of the mental health system.315 this revolving-door refers to the cycling of mentally ill persons through jail, homelessness, and hospitalization due to inadequate mental health care sys­ tems.316 the n.y. report is one of the first to specifically link pvot to this type of socio-economic data. the results are an impressive model for other ju­ risdictions, especially large metropolitan areas. nonetheless, more data needs to accumulate to either support or refute the results of then. y. report. a critiearly morning rounds visiting ninety-two psychiatric inmates at roughly 12.7 seconds per in­ mate; the doctor is saddened that there are not more psychiatrists on staff and that he cannot provide better care for them by telling earley, " 'mentally ill people don't belong in jail ... by its very design, a jail like ours is intended to dehumanize and humiliate a person .... this sort of atmosphere is counter to treatment or helping to improve anyone's mental health .... "'). 310 e.g., id. at 54 (describing an account of an inmate at miami-dade who tells the prison psychiatrist that he is bipolar and taking zyprexa, but the prison does not prescribe it to him because the psychiatrist is required to prescribe risperdal first as it is less expensive). 311 wegkamp, supra note 116, at 73-77, 93, 161 (describing the family's frustration at being prohibited from visiting their mentally ill son in prison except for brief thirty minute phone visits--behind a glass wall-once a week). 312 see earley, supra note 304, at 45, 47 (describing the unsanitary conditions at the miami-dade county jail on the psychiatric floor, which arguably speed up the development of a severe mental illness). 313 n.y. report on kendra's law, supra note 251, at 18 tbl.lo & fig.5. 314 jd. 315 see, e.g., kress, supra note 24, at 1273. 316 see id. (stating that the revolving-door phenomena refers to mentally ill persons who "continuously revolve in and out of hospitals"). 416 indiana health law review [vol. 4:361 cism of then. y. report is that it is based on only the first five years of data. 317 further, adherence to treatment past the initial six months is still largely un­ known and needs to be monitored. several researchers have suggested that one reason why there are so many mentally ill homeless persons today is a result of the deinstitutionalization movement, which began in the mid-1950s. during this movement, accelerated by the medicaid exclusion,318 numerous patients were released from hospitals, and sometimes the mental hospitals themselves were shut down. to illustrate, in 1955, the united states had 558,239 patients in state and county psychiatric hospitals, when the total population was 164 million. 319 but by 1996, the num­ ber of patients in state and county psychiatric hospitals had dropped to only 61,722 in a population that had increased to 265 million. 320 this is a dramatic ninety-three percent reduction rate in the hospitalization of the mentally ill. 321 while a return to the horrors of institutionalization is certainly not the answer today, these dramatic figures hint that a substantial number of persons, espe­ cially in light of population increases, may be in need of mental health treat­ ment. instead, a large percentage of such persons may be living on the streets. in general, the majority of homeless persons are not homeless due to a mental illness and are typically homeless for only a short period of time, often attributed to an unexpected event such as an eviction, natural disaster, or house fire. 322 nonetheless, those who are homeless for longer periods, including the chronically homeless, tend to have disabling health problems, such as mental illness.323 of the estimated 200,000 people who experience chronic homeless­ ness, at least twenty percent have serious mental illness. 324 317 seen.y.reportonkendra'slaw,supranote251, at 1, 5, 7. 318 see supra note 12. 319 davoli, supra note 9, at 174 & n.84 (quoting treatment advoc. ctr., briefing paper: repeal of the institutions for mental disease exclusion, available at http://www.psychlaws.­ org!hospitalclosure!repeal.htm (last visited apr. 11, 2007)). 320 id. 321 ld. 322 u.s. dep't health & human servs., blueprint for change: ending chronic homelessness for persons wtihseriousmentalillnessandior co-occurring substance use disorders 3 (2003), available at http://download.ncadi.samhsa.gov/ken!pdt7sma043870/sma04-3870.pdf [hereinafter ending chronic homelessness for persons wtih serious mental illness]. 323 ld. 324 id. los angeles county recently released its 2005 report on homeless populations. l.a. homeless servs. auth., 2005 greaterlosangeleshomeless count (2006), available at http://www .lahsa.orglhomelesscount/pdfs!lahsa %20report"lo20-o/o20final%20v ersion64.pdf [hereinafter l.a. homeless servs. auth.]. of the total82,291 homeless individuals at any given point in time in los angeles county, over thirty-four percent reported to be experi­ encing mental illness. id. at 3, 8. this is a higher percentage than suggested by the united states department of health and human services' national survey of the homeless who are mentally ill. ending chronic homelessness for persons wtih serious mental illness, supra note 322 (estimating twenty percent). the los angeles report noted that approximately 2007) toward a tweniy-firstcenturycivilcommitmentstatute 417 additionally, "as many as two-thirds of all people with serious mental ill­ nesses have experienced homelessness or have been at risk ofhomelessness at some point in their lives ... 325 there are several reasons why severely mentally ill persons might have difficulty obtaining stable housing over the course of a developing lifelong illness. mentally ill individuals may be evicted from apartments for actions such as disturbing neighbors, missing rent or utility payments, and neglecting general housekeeping. 326 eviction may also result from a difficulty in developing and maintaining comfortable social relationships with other tenants or neighbors. 327 mentally ill individuals may become lonely and isolated, and often have social conflicts with family, employers, landlords, and neighbors. 328 also, mentally ill persons who are subject to hospitalization or incarceration may lose their housing when they are unable to pay rent during such periods. 329 mentally ill persons may also have difficulty in both obtaining and maintaining employment due to their illnesses, and therefore may be unable to pay utilities or rent payments. discrimination and stigma associated with mental illness, coupled with homelessness, are often significant impediments to accessing housing. 33° furthermore, mentally ill homeless individuals may also become victims of assault on the streets or in shelters, and may be ill equieped to defend themselves in a life threatening situation due to their illnesses. 31 lack of economic resources or low socio-economic status, however, does not correlate with homeless persons who are mentally ill. 332 this tends to sug­ gest that personal financial resources are not the cure for such a mentally ill individual's illness or chronic homelessness. additionally, mentally ill indi­ viduals may be homeless due to choice, or due to their self-perceived inability to live near others stemming from unwanted delusions and hallucinations. such an individual may genuinely be happier (amidst the illness), regardless of how much money he or she has, to remove him-or-herself from society alto­ gether. hence the root cause of chronic homelessness as it intersects with perfifty percent (34,512) of the homeless were experiencing "chronic homelessness." l.a. homeless servs. auth., supra note 324, at 6. chronic homelessness was defined as "[a]n unaccompanied individual with a disabling condition who has been continually homeless for one year or more, or has experienced four or more episodes ofhomelessness within the past 3 years." id at 6. the los angeles report supports national statistics regarding the correlation of homelessness and mental illnesses, and in addition to being the most recent and thorough study ofhomelessness in a large metropolitan area, suggests that combating mental illness may allevi­ ate some of the percentages of those who are chronically homeless. 325 homeless servs. auth., supra note 324, at 12. 326 id. at 12. e.g., michael jenuwine & robert jones, professors oflaw, university of notre dame university law school, panel address at norman amaker public interest law and social justice retreat: seeking justice for people with mental illness (feb. 24, 2007). 327 homeless servs. auth., supra note 324, at 12. 328 id. 329 id. at 13. 330 id. at 25. 331 see id. at is. 332 davoli, supra note 9, at 176. 418 indiana health law review [vol. 4:361 sons who are mentally ill may simply be the severity of the illness itself. ad­ dressing the illness first and foremost through statutes such as pvot seems to be an appropriate step in remedying the problem of the mentally ill who are homeless. e. other benefits of pvot new york counties also reported that the implementation of pvot re­ sulted in beneficial structural changes to local mental health service delivery systems. 333 then. y. report identified three beneficial administrative changes: "[ 1] ... enhanced accountability in iocal mental health service systems .... [2] improved access to services for high need individuals, ... [and 3] the develop­ ment of more collaborative relationships between the mental health and court systems."334 hence, the structure and detailed procedures ofpvot improved the general quality of mental health care throughout the state of new york. 335 additionally, in compiling data for the n.y. report, patients themselves were surveyed and asked about how they felt about their experience with pvot. certainly, some patients reported that being court-ordered for purposes of receiving psychiatric treatment was an embarrassing and humiliating event, yet sixty-two percent of patients reported that being court-ordered into treat­ ment was an overall "good thing. ,,336 of this sixty-two percent, additional posi­ tive responses regarding treatment were reported. eighty-one percent reported that ''the pressures or things people have done to get them to stay in treatment helped them to get and stay well.'.j37 seventy-five percent reported that treat­ ment helped them gain control over their lives. 338 ninety percent reported that treatment had made them more likely to keep appointments and take medica­ tion. 339 and eighty-eight percent reported that they trusted their case managers and felt good that they also had a role in determining their own treatment plan. 340 while thirty-eight percent of patients appeared not to have a positive response to pvot, the majority of the patients in the end felt positive about the treatments they were receiving, though it was no doubt a very difficult emo­ tional process. in sum, then. y. report provides positive and promising evidence to link to the current policy efforts to implement pvot statutes. the results suggest that pvot is targeting a specific population of severely mentally ill individuals, is helping to assist these individuals with treatment, and at the same time is im333 n.y. report on kendra's law, supra note 251, at 4. 334 id. 335 id. 336 id. at 20. 337 id. at 20-21. 338 /d. at 21. 339 id 340 see id. 2007] toward a twenty-firstcenturycivilcommitmentstatute 419 proving the mental health delivery system. ix. the truth behind laura's law-the california ghost law unlike kendra's law, which automatically became the law in the entire state ofnew york upon its enactment (and was sufficiently funded to do so),341 laura's law has not been adopted on a state-wide basis in califomia.342 in­ stead, laura's law has been enacted with a provision that makes it optional for counties to adopt it. 343 therefore, if a california county chooses to adopt the law,344 that county alone is required to provide the funds for the pvot treat­ ment plans as well as adhere to specific requirements regarding provider ser­ vices according to state law.345 341 for example, during the fiscal year of2005-2006 new york governor george e. pataki budgeted thirty-two million dollars for the operation of services in support of kendra's law. see id. at 2. during that same fiscal year, governor pataki also budgeted more than $125 million to "expand the capacity of the existing community-based mental health system and to strengthen the cohesiveness and coordination of that system." id. at 3. 342 laura's law, cal. welf. & inst. code §§ 5346(a), 5348 (west supp. 2007). the mental health system in california, however, is statutorily authorized and financed on a county­ by-county basis. see bronzan-mccorquodale act, cal. welf. & inst. code § 5600 (west 1998). 343 id. one unique issue that laura's law's county-enactment provision seems to suggest is that persons in different counties throughout the state who are severely mentally ill may be subject to radically different types of treatment throughout the same state. see generally cal. welf. & inst. code § 5600 (authorizing a county-by-county mental health care system in cali­ fornia). so a person in los angeles county might be able to receive pvot (if the county had adopted it) but a person in alameda county might not (assuming pvot were not adopted). therefore it might be said that the state of california is denying the equal protection of severely mentally ill persons throughout the state under the optional county provision, in which geo­ graphic county location determines the level and type of psychiatric treatment. but the united states supreme court has never held that mentally ill persons constitute a suspect classification, which would implicate mid-level or strict scrutiny of the county provision. see supra part vii and notes 231, 243-44 and accompanying text. even so, similar to city of cleburne v. cleburne living ctr., 473 u.s. 432 ( 1985), a heightened level of rational review would likely be applied to evaluate the constitutionality of the county provision. see supra part vii and notes 244-46 and accompanying text. under a heightened rational review standard, a court would likely find that the state of california has a rational interest in enacting laura's law on a county basis that is reasonably tailored to the state's objectives. namely, california lacks the resources to imple­ ment laura's law on a statewide basis and counties are arguably the best judges of how their mental health systems should be run. 344 in los angeles county there are five members of the board of supervisors who made the decision to implement laura's law and finance it on behalf oflos angeles county. tele­ phone interview with kirsten deichert, legislative and public information officer, l.a. county department ofmental health, in l.a., cal. (jan. 2006). other counties in california that wish to implement laura's law should contact their county board of supervisors. treatment aovoc. ctr. & cal. treatment aovoc. coal.,agumetolaura's law: california's new law for assisted outpatient treatment 15 (2d ed. 2003). 345 cal. welf. & lnst. code§ 5348(a)-(d). 420 indiana health law review [vol. 4:361 for example, laura's law requires that each county provide mental health teams that have no more than ten patients per mental health provider.346 while the small patient to provider ratio creates an optimal health care setting for men­ tal health providers and patients, in reality, this is extremely costly and difficult to follow for counties with limited resources. quite possibly, even the standard influx of employees that may leave a mental health hospital would have the power to make any county's use of laura's law unlawful and in violation of the statute. additionally, laura's law requires that counties must provide the following mental health services under pvot: 1) outreach to families whose severely mentally ill relative lives with them as well as family support services generally;347 2) staff with the cultural background and linguistic skills necessary to help patients who cannot speak english;348 3) therapy that employs psycho­ social rehabilitation;349 4) services aimed to help mentally ill adult individuals age twenty-five or younger who are at a significant risk of becoming home­ less;350 5) services reflecting the special needs of women, including issues such as domestic violence and raising children; 351 7) supportive housing that is im­ mediate, transitional, and/or permanent; 352 and 8) a designated mental health personal services coordinator for each patient.353 to the extent feasible, laura's law requires that counties design treatment programs that include the following services: 1) vocational counseling and academic planning;354 2) main­ tenance of and access to physical health care;355 and 3) substance abuse coun­ seling. 356 furthermore, each county that adopts laura's law must provide data to the state department of mental health that will generate an annual report to the legislature concerning laura's law.357 the report must include the follow­ ing (creating yet another expense for counties, 358 though certainly crucial to evaluating the success or failure of the law): 1) the number of patients receiving 346 id § 5348(a)(l). comparewithkendra'slaw,n.y.mentalhvo.law§9.60(axl) (mckinney 2006). see also n.y. mental hyg. law § 41.42 (family support programs); § 41.39 (vocational programs);§ 41.13 (powers and duties oflocal government units). 347 cal. welf. & inst. code§ 5348(ax2)(b), (e). 348 /d. § 5348(a)(2)(b). 349 id. § 5348(a)(2)(f). 350 /d § 5348(a)(2)(h). 351 id § 5348(ax2)(1). 352 id § 5348(ax2xj), (4)(a). 353 id § 5348(ax3). 354 id § 5348(a)(4)(b), (d), (e). 355 /d.§ 5348(a)(4)(g). 356 /d.§ 5348(a)(4)(j). 357 /d. § 5348( d). 358 cf. barbara a collins, mental health court judge, marion county, ind., remarks at starting a mental health court in your community, panel speaker at the 4th annual mental health & criminal justice summit, indianapolis (mar. 23, 2007) (stating that the cost ofkeep­ ing data concerning a judge-driven mental health court is nearly impossible without increased funding). 2007] toward a twenty-first century civil commitment statute 421 pvot;359 2) the number of patients with a criminal history and the extent to which criminal behaviors are reduced with the implementation ofpvot;360 3) number of persons participating in employment programs;361 4) days of psychi­ atric hospitalization that have been reduced or avoided;362 5) medication adher­ ence rates;363 6) violent acts committed by persons in the program;364 7) substance abuse reduction rates;365 8) social functioning of persons in the pro­ gram;366 and 9) reports from patients and family members as to the success or failure of pvot. 367 additionally, any california county that wishes to adopt pvot must provide all of the same services on a voluntary basis. 368 therefore, any county that wishes to adopt pvot in order to target the population of per­ sons who are severely mentally ill and arguably lack insight into their illnesses must also equally provide such services to persons who meet the criteria but wish to obtain the treatment voluntarily. based on the laundry list of requirements laura's law imposes on coun­ ties that choose to adopt pvot (though it is a very positive laundry list), it is easy to see how very quickly the adoption of laura's law in any given county effectively requires an expensive renovation of an entire mental health service delivery system. while this is a noble undertaking that should be encouraged, it is also extremely expensive for most counties to undertake single-handedly without state-wide financial support. many california counties are already un­ der-budgeted for mental health care services and are trying to do the best they can with the resources available.369 therefore, laura's law's mental health services requirements seem to set up an unfortunate barrier to the implementa­ tion oflaura's law in california, provided that the state continues to place the entire financial responsibility in the laps of local counties. los angeles county is the only one of the fifty-eight counties in califor359 cal. welf. &lnst. code§ 5348(dx1). 360 id § 5348( dx2). 361 jd § 5348(d)(3). 362 id. § 5348(dx4). 363 id. § 5348(dx5). 364 /d. § 5348(d)(8). 365 id § 5348(dx9). 366 /d. § 5348(d)(l2). 367 /d. § 5348(dx14). by analogy mental health courts often do not have enough re­ sources to keep such data on those that are diverted though their courts. mental health court panel at the 4th annual mental health & criminal justice summit, indianapolis (mar. 23, 2007). 368 cal. welf. & inst. code§§ 5347(a), 5346(exl)-(2); see also e-mail from rusty selix, executive director, mental health association in california (mar. 11, 2007, 10:42:16 edn (on file with author). 369 scott gold, lee romney & evan halper, program for mentally ill eliminated; before signing the budget, schwarzenegger kills the $55-million initiative that aids the home­ less. counties can fund it, an aide says., la times, aug. 25, 2007, at b 1 (''counties across ... [california] are facing the slow erosion of their traditional mental health budgets."). 422 indiana health law review [vol. 4:361 nia that has attempted to implement laura's law.370 nevada county, the county in which laura wilcox was murdered by a man suffering from schizo­ phrenia, has also taken a close look at adopting the law, though it has not as yet done so.371 nonetheless, los angeles county's attempt at implementing laura's law has been extremely limited, but not limited enough to fail to stir­ up major controversy within the state and instigate a lawsuit against the county that ended in settlement. ultimately, los angeles county's use oflaura's law has proven, for the most part, nearly nonexistent. 372 this effect seems to have trickled over and throughout the rest of the state. the program to implement laura's law in los angeles county was not technically laura's law as we know it. rather, it was a voluntary pilot pro­ gram with a few of the same concepts since the county was not able to fund a full adoption of the law. 373 in effect, the partial adoption excluded the core lan­ guage and purpose oflaura's law, acting more as a diversion program for per­ sons already in the criminal justice system. 374 nonetheless, the partial adoption may have proven to be more legally problematic than los angeles county ini370 see county of l.a., state of cal., resolution implementing a pilot project of "laura's law'' (assembly bill 1421): "assisted outpatient treatment'' (2002) (on file with author); county of l.a., state of cal., minutes of the board of supervisors (oct. 7, 2002) (on file with author); letter :from marvin j. southard, director of the department ofmental health in the county of l.a., to each supervisor of l.a. county (nov. 5, 2002) (on file with author) (''to comport with the spirit of the statute, but given the fiscal and program restraints at this time, dmh proposes a limited implementation of aot in collaboration with the superior court. dmh proposes that intake to the aot program exist for individuals who are exiting the crimi­ nal justice system with relatively minor offenses. j; letter from marvin j. southard, director of the department ofmental health in the county ofl.a., to supervisors ofl.a. county (jan. 16, 2003) (on file with author) (recommending that the board of supervisors adopt the pilot project oflaura's law). contra cal. network ofmental health clients, ab 2357-why oppose it, supra note 200 (arguing that the law was never formally adopted). 371 cal. network of mental health clients, ab 2357-why oppose it, supra note 200. some have argued nevada county's attempts to implement the law are part of a settlement agreement with laura wilcox's family over her death. id see also dave moller, second try for laura's law: it is hoped new version will retire sunset date, add funds, 1heunion.com, mar. 2, 2006, at http://www.theunion.com/article/20060302/newsii03020136 (stating nevada county was hoping to use proposition 63 funds to implement it). 372 see fritz, supra note 8, ata12 (suggesting laura'slawhasyetto be used even in los angeles county). 373 see cal. welf. & inst. code § 5347 (adopting only the subsection, titled "voluntary treatment; settlement agreements," made it possible for los angeles county to use laura's law to divert some severely mentally ill persons :from the criminal justice system to the mental health system arguably without adopting the subsections that included eligibility criteria and third party petitions). see also complaint for declaratory and injunctive relief and petition for writ of mandate at 7, cal. network of mental health clients v. county of l.a. (no. bc310719) (super. ct. cal., l.a. county, feb. 18, 2004) [hereinafter complaint]. 374 e-mail attachment :from alisa dunn, director, l.a. county mental health depart­ ment, voluntary assisted outpatient treatment program (mar. 27,2007,04:55:31 ed1) (on file with author). 2007] toward a twenty -first century civil commitment statute 423 tially realized. 375 a lawsuit was filed against los angeles county, the los angeles county board of supervisors, and the los angeles county department of mental health by a non-profit mental health organization that is politically against in­ voluntary treatment and laura's law. 376 the complaint alleged that the defen­ dants of los angeles county had arbitrarily operated an involuntary pvot program because laura's law only permits pvot if express statutory criteria are met. 377 even though the lawsuit ended in settlement, 378 it is certainly possi­ ble that los angeles county had not carefully adhered to all of the arguably expensive and expansive criteria required by laura's law. these criteria in­ cluded meeting the detailed service provider requirements379 as well as provid­ ing voluntary services to persons selected for pvot.380 specifically, plaintiffs alleged that the persons whom los angeles county had selected for pvot were never offered pvot on a voluntary basis because they were already in the criminal justice system when pvot was offered.381 hence, pvot was being used as a device to divert them from charges or jail, and was arguably not being offered simultaneously on a true voluntarily ba­ sis.382 additionally, the complaint alleged that los angeles county was selec­ tively hand-picking those persons that it wanted to divert through pvot based on open-seat availability, thereby not offering it to all persons who might oth­ erwise qualify under laura's law. 383 this is the way that many mental health courts currently lawfully operate throughout the country today, but because los angeles county chose to implement this diversion program under the guise of aspects of laura's law, this posed legal problems that many other counties throughout the country would not have endured. the complaint further alleged more generally that 375 complaint, supra note 373, at passim. the l.a. county program was effective in 2003. ld. at 9. 376 !d. at passim; see generally cal. network of mental health clients, policy arguments against implementation of ab 1421, http:l/www.califomiaclients.org/policy/policy_argue­ ments.cfin (opposing laura's law) (last visited apr. 1, 2007); cal. network of mental health clients, ab 2357-why oppose it, supra note 200 (opposing laura's law). 377 complaint, supra note 373, at 2. 378 see final settlement agreement and general release, cal. network ofmental health clients v. county of l.a. (no. bc 310719) (sept. 28, 2005) (on file with author) [hereinafter final settlement agreement]. 379 complaint, supra note 373, at 6, 9. see also cal. welf. & inst. code § 5348(a) (west supp. 2007). see supra notes 344-51 and accompanying text. 38° complaint, supra note 373, at 9. 381 id. at 7, 9. 382 id. at 7-8. los angeles county's program was to exist for individuals found to be incompetent to stand trial in misdemeanor cases. ld. at 8. 383 !d. at 9 ("based on information and belief, defendants will offer voluntary services to persons subject to a ... [pvot] investigation only if there are slots available under the county's existing ... programs .... "). 424 indiana healm law review [d]efendants' actions and inactions force persons with psychiatric disabilities into unnecessarily restrictive set­ tings instead of providing appropriate outpatient treat­ ment, erode mental health client trust, infringe on the fundamental right to privacy and informed choice, per­ petuate discrimination and stigma, undermine statutorily mandated court processes, and threaten to increase po­ lice detention of people with psychiatric disabilities for petty offenses to obtain appropriate services. 384 [vol. 4:361 defendants responded by ducking most of the substantive issues raised by the complaint and focusing on procedural issues in hopes of a judgment at the pleading stage in their favor. 385 they also highlighted the recently upheld con­ stitutionality ofkendra's law in new york,386 and expressed that under the county's pilot program, petitions for pvot were only filed for persons who agreed to accept services under the voluntary agreement for services section. 387 one year and six months after the original comflaint was filed, the parties reached a settlement and the case was dismissed. 38 the final settlement in­ cludes the following agreement between the parties, which will expire on janu­ ary i, 2008 (presumably, this date was chosen because at the time of the agreement, this was the date on which laura's law would have sunset, how­ ever, the sunset date was recently amended and extended until january 1, 2013).389 first, the parties agreed that the term "laura's law" would not be used by the los angeles county mental health department in reference to its limited pvot program based on laura's law.390 "'any law named after a single person can be an emotional reaction,'" said the executive director of the nonprofit agency that brought the suit 391 instead, the los angeles county 384 ld at 3. 385 points and authorities in support ofmotion for judgment on the pleadings at 4, 9, cal. network ofmental health clients v. county of l.a. (no. bc 31 0719)(sept 22, 2004) (on file with author) [hereinafter defendant's motion for judgment on the pleadings]. defendants made two primary procedural arguments in response to the complaint: 1) that the plaintiff cor­ poration lacked standing; and 2) that the plaintiff failed to name indispensable parties. id con­ tra memorandum ofpoints and authorities in opposition to defendants' motion for judgment on the pleadings, cal. network ofmental health clients v. county of l.a. (no. bc 310717) [sic] (mar. 24, 2005) (on file with author). 386 see defendant's motion for judgment on the pleadings, supra note 385, at 6. 387 id at3. 388 request for dismissal, cal. network ofmental health clients v. county ofl.a (no. bc 3107l9)(sept. 29, 2005)(on file with author). 389 final settlement agreement, supra note 378, at 7. see also laura's law, cal. welf. & inst. code § 5349.5 (west supp. 2007) (extending the sunset date until20 13 but requiring that the state department ofmental health submit a report regarding the use oflaura's law in california by july 31, 2011 ). 390 see final settlement agreement, supra note 378. at 2, 391 dave moller, laura's law may be extended. theunion.com. apr. 24. 2006, avail2007] toward a twenty-firstcenturyclvn..commitmentstatute 425 mental health department agreed and is therefore only permitted to refer to its limited application of "laura's law" as the "voluntary assisted outpatient treatment program. "392 the term ''voluntary," however, is clearly contrary to one of the key purposes of laura's law: to treat the severely mentally ill who lack insight into their illnesses and therefore are unlikely to seek voluntary treatment. 393 nonetheless, los angeles county maintained from the beginning that it had only adopted laura's law on a voluntary basis through the criminal diversion program. second, the parties agreed that los angeles county would be permitted to continue to operate its limited pilot program ofvoluntary as­ sisted outpatient treatment but under a few conditions: 1) if the program ever exceeds fifty patients, the county must notify plaintiff's counsel; 2) if the county wishes to change or recommend any changes that would make the pro­ gram involuntary in any nature, it must provide plaintiff's counsel thirty days advanced notice prior to filing any letter of such recommendations to the board of supervisors; 3) the county will make clear that the only aspect of laura's law being used is the voluntary settlement process. 394 simply conceding that the program will likely never exceed fifty patients also suggests how limited the application of this pilot program is due to lack of resources to finance it. in exchange for this agreement from los angeles county, the plaintiff agreed to able at http://www.theunion.com/article/20060424/news/l 04240143. 392 see final settlement agreement, supra note 378, at 2. 393 cal. welf. & inst. code§ 5346(axs) (stating that the person has been offered an opportunity to voluntarily participate in pvot but continues to fail to voluntarily participate). 394 final settlement agreement, supra note 378, at 3 (the "voluntary settlement" section of laura's law is cal. welf. & inst. code§ 5347). see also e-mail attachment from alisa dunn, director, l.a. county mental health department, voluntary assisted outpatient treat­ ment program (mar. 27,2007,04:55:31 edt) (on file with author) (specifying the limited op­ eration of los angeles county's "voluntary assisted outpatient treatment program). candidates for pvot in los angeles county currently include the following: 1) misdemeanor incompetent to stand trial defendants who have been restored to competency; 2) misdemeanor defendants who are at risk ofbecoming incompetent to stand trial; and 3) consumers who are transitioning from community reintegration programs. ld at 1. the enrollment process virtu­ ally ignores the language of laura's law that permits family members and other designated parties to.request that the director file a petition on behalf of a third party and additionally fo­ cuses solely on defendants with a criminal history. see id. qualifying candidates are offered aot and if they agree to treatment, the mental health designee files a petition for aot. the petition is filed after candidates have been restored to competency and their criminal court case has been resolved .... the aot court process . . . consists of consumers entering into a settlement agreement .... consumers who have completed an alternative sentencing program through dmh community reintegration may also be referred for aot if they meet the criteria and express a desire to enroll in the program. candidates are referred to the men­ tal health designee at court 95 and enter into the settlement agreement as de­ scribed above. i d. at 1-2. additionally, the treatment provider has a client-staff ratio often to one with "service plans that address at least eleven elements prescribed in the statute." ld at 2. 426 indiana healm law review [vol. 4:361 file a dismissal without prejudice of the entire lawsuit against all defendants and not bring any claims arising from the legal action. 395 in summary, california's laura's law, though enacted in2002,hasas yet to be implemented by any california county. los angeles county, one of the largest counties in the state, lacked finances to fully implement the law but still chose to do so in a limited fashion. even so its limited usage ultimately has currently stymied the use of the law within the county (except on a very limited voluntary basis) and possibly even the entire state. other counties looking for reasons not to attempt implementing laura's law have only to look to the ex­ ample of los angeles county. los angeles county was sued by non-profit mental health organizations for arguably failing to meet stringent statutory crite­ ria. the lawsuit is extremely unfortunate because it· has effectively deterred other counties from adopting laura's law within the state. nonetheless, counties that may wish to adopt laura's law should remem­ ber that the primary reason los angeles county settled the lawsuit was not be­ cause there was anything wrong with the substance of laura's law-for example, that it was weak in its constitutional structure-but mther because los angeles county simply executed it in a poor and arguably inadequate man­ ner.l96 if other california counties are interested in adopting laura's law, the primary hurdle in executing it properly is the provision mandating full financial responsibility onto local counties. in the mean time, counties interested in im­ plementing the law should rigidly follow the standards and criteria laura's law sets forth. if counties are able to finance laura's law in full and meet all the guidelines, it is likely that laura's law will survive constitutional attacks as kendra's law has in the state ofnew york.397 additionally, if a california county adopts laura's law, data within the state of california will begin to ac­ cumulate concerning pvot, which will be important to determine whether the law as written has the power to help a population of severely mentally ill per­ sons in the state of california. a. proposition 63: the mental health services act hope for financing laura's law in its voluntary aspects, may have re­ cently come with the passage of proposition 63 in 2004. 398 proposition 63 re­ quires individuals with a personal annual income of over one million dollars to 395 final settlement agreement, supra note 378, at 3. 396 cj cal. welf. & inst. code§ 5348. see als-o supra notes 344-53 and accompanying texl 397 see supra part vii and notes 219-29 and accompanying texl 398 mental health services fund, cal . .rev. & tax. code§ 17043 (west supp. 2007); cj watnik, supra note 222, at 1228 ("for kendra's law to be implemented successfully, the legis­ lature must commit financially to making it work. adequate funding is critical to ensure the availability of community treatment programs. a court order for [pvot] is meaningless unless the resources are available to.implement il''). 2007] toward a twenty-first century crvn.. commitment statute 427 pay a one percent tax, which goes directly toward expanding and improving the california mental health system. 399 "the tax surcharge [is estimated to] gener­ ate new state revenues of approximately $27 5 million in 2004--05, $750 million in 2005-06, $800 million in 2006-07, and probably increasing amounts annu­ ally thereafter.',.4()0 the catch, however, is that the funds may only be used to genuinely expand services for severely mentally ill persons, and as the law cur­ rently provides, on a voluntary basis. 401 nonetheless, investing in reforming and improving voluntary services will likely be indirectly related to effectively implementing many of the service-provider criteria set forth in laura's law. if finances are used to provide counties with higher quality services, including better staff-to-client ratios, it may be more realistic and somewhat less expen­ sive for counties to adopt laura's law in the near future.402 with much mental health reform currently underway in the state of california, primarily through funding from the mental health services act, why not make efforts to imple­ ment a new involuntary law that has proven to reduce violence, homelessness, and criminalization of the mentally ill't03 involuntary civil commitment statutes more generally are going to cost more money than voluntary civil commitment statutes as they likely come with more resistance and in turn, more litigation and appeals. finances, however, are not the only obstacle to implementing laura's law in california. supervi399 cal. welf. & lnst. code§ 5891. 400 legislative analyst's office, http://www.lao.ca.gov/ballot/2004/63 _11_ 2004.htm (last visited mar. 8, 2006). 401 cal. welf. & lnst. code§ 5891 ("the funding established pursuant to this act shall be utilized to expand mental health services. these funds shall not be used to supplant existing state or county funds utilized to provide mental health services."); i d. § 5801 (b )(5) ("the client should be fully informed and volunteer for all treatment provided, unless danger to self or others or grave disability requires temporary involuntary treatment.") (emphasis added). see also daniel brzovic, protection &advocacy, inc., proposffion 63 and involuntary services 1, 3-6 (2004), available at http://www.pai-ca.org/advocacy/prop63/prop63andab142l.pdf ("proposition 63 provides that proposition 63 funds can only be used to pay for specific, listed programs.") (describing why proposition 63 funds may not be used to fund laura's law). one might argue that proposition 63 violates the equal protection clause by providing funds to improve mental health services for voluntary rather than involuntary patients. see su­ pra part vii and notes 242-46 and accompanying text. but again, since rational review is likely to be the standard of review applied, the policy choice to target a specific class of mentally ill persons-those who wish to seek services voluntarily under the mental health services act­ would likely be upheld. see city of cleburne v. cleburne living ctr., 473 u.s. 432 (1985). nonetheless, it is interesting at least to consider how the broader class of severely mentally ill persons is arguably unequally treated throughout the state of california under proposition 63. 402 see also e-mail from rusty selix, co-author, proposition 63, executive director, mental health association in california (mar. 20, 2007 09:16:42 edt) (on file with author) (stating that increasing the number of persons receiving voluntary treatment will also likely de­ crease the number of persons in need of involuntary treatment). 403 contra cal. network ofmental health clients, ab 2357-whyoppose it, supra note 200 ("before resorting to the extreme measure of denying the rights of a whole group of persons [under laura's law], give these voluntary community services a chance."). 428 indiana health law review [vol. 4:361 sor helen thompson. the former assemblymember of california who originally introduced the bill, stated that the primary reason for the law's unpopularity is not a lack of state or local funds but rather the political opposition from civil rights groups.404 this note shows that laura's law is still a very conservative movement away from the danger statutes, and although it is largely involuntary in nature, it has many procedural safeguards set-up within it to protect the civil liberties of the severely mentally ill. x. alternativestopvot a. mental health courts as criminal diversion programs mental health courts are currently being implemented throughout the country to divert the severely mentally ill from the criiilinaljustice system.405 404 telephone interview with supervisor helen thompson, board of supervisors, yolo county, cal., in l.a; cal. (jan. io, 2006). 405 symposiwn, mental health courts, ii psychol. pub. pol'y & l. 507 (2005); susan stefan & bruce j. winick, a dialogue on mental health courts, 11 psychol. pub. pol'y &l. 507, 507 (2005) (''the basic assumption underlying the mental health court model is that, for at least some defendants charged with minor nonviolent offenses and, in some cases, even for those charged with felonies, the problem is more a product of mental illness than of criminality and that facilitating the offender's access to mental health treatment is a more effective response to the underlying problem than criminal conviction and sentence."); allison d. redlich et al., the second generation of mental health courts, ii psychol. pub. pol'y & l. 527,527 (2005) (stating that between 1998 and 2003 the number of mental health courts in the united states increased from roughly ten to eighty); see also lisa shoaf. a case study of the akron mental health court, 32 cap. u.l. rev. 975, 975-77 (2004) (describing akron, ohio's mental health court). often "mental health court'' is the simply the term used to describe regular roundtable discussions (often on a weekly basis) between the prosecutor, public defenders, mental health experts, and the trial court judge concerning persons believed to be suffering from severe mental illnesses who have been charged with non-violent crimes. mental health court panel, 4th an­ nual mental health & criminal justice summit; indianapolis (mar. 23, 2007). some courts, however, have begun to open up these diversion programs or "mental health courts" to severely mentally ill individuals charged with felonies or more violent crimes. carol fisler, building trust and managing risk: a look at a felony mental health court, 11 psychol. pub. pol'y & l. 587, 587-88 (2005) (describing the brooklyn mental health court ofnew york). see also leslie k.aufinan, court for mentally ill defendants will start today, n.y. times, oct. 1, 2002, at b3 (describing the official opening of the brooklyn mental health court). the first mental health court arguably took place in marion county, indiana under the direction of judge evan goodman in 1996. posting ofbob cardwell, introduction: the pair mental health diversion program of marion county, to bttp://pairprogram.blogspot.com/2005/01/introduction.html, (jan. 26, 2005, 10:08 est) (stating additionally that the court has roots in the psychiatric assertive identification referral/response (''pair") program ofmarion county, indiana, which was an informal diversion program for the severely mentally ill charged with crimes that began in the early 1980s). cf. stefan & winick, supra note 405, at 507 (stating that the first mental health court in the united states to receive national attention was that of broward county, florida in1997). 2007] towardatwenty-fmstcenturycivjlcommitmentstatute 429 these courts are mostly judge-based and judge-driven, and therefore, when the individual judge leaves, the mental health court also leaves.406 the primary critique of mental health courts is that they often step in too late, after a crimi­ nal act has been committed before offering treatment 407 nonetheless, their primary virtue is that they are diverting the mentally ill from incarceration, a setting that is likely to exacerbate psychiatric symptoms and lead to further de­ terioration.408 one problem with relying on mental health courts, however, is that because they are judge-driven they are not uniform and fail to have the same power that state-wide legislation has to reform the mental health system on a broader basis. 409 nonetheless, on a case-by-case basis, the goals of mental health courts are consistent with many of the same purposes and goals ofpvot statutes. b. rebuilding and expanding inpatient hospitals another alternative to pvot, though initially it might sound a bit back­ wards, is to bolster the image and resources available to inpatient psychiatric hospitals by encouraging innovation and reducing the stigmatization associated with these facilities. a well-monitored and structured hospital may be the best hope for some severely mentally ill persons' long term improvement.410 this might even be particularly true during the first several years of the development 406 robert bernstein & tammy seltzer, criminalization of people with mental illnesses: the role of mental health courts in system reform, 7 d.c. l. rev. 143, 147, 149 (2003); bar­ bara a. collins, mental health court judge, marion county, ind., remarks at starting a mental health court in your community, panel speaker at the 4th annual mental health & criminal justice summit, indianapolis (mar. 23, 2007). 407 tammy seltzer, mental health courts: a misguided attempt to address the criminal justice system's unfair treatment of people with mental illnesses, 11 psychol. pub. pol'y & l. 570, 572-73, 577, 581-83 (2005) ("to avoid becoming the entry point for people abandoned by the mental health system, mental health courts should close their doors to people charged with minor misdemeanors, as does the brooklyn mental health court, which handles only felo­ nies and misdemeanors 'that would likely result in a jail sentence.' •.. the criminal and juvenile justice systems are not the appropriate front door to access mental health care .... to eliminate the unnecessary and harmful criminalization of people with mental illnesses, communities must address the causes of the problem, not just its symptoms.'') (quoting anew york state office of mental health report). 408 see stefan & winick, supra note 405, at 507 (explaining, however, that scientific research still needs to be done to evaluate the effectiveness such courts). 409 see collins. supra note 406. see also nancy wolff & wendy pogorzelski, measuring the effectiveness of mental health courts: challenges and recommendations, 11 psychol. pub. pol'y & l. 539, 541-42 (2005) ("mental health courts are fluid, nonstandardized entities.j (citation omitted). cf corrections mental health act of2007, s.b. 851,2007-08 leg., reg. sess. (cal. 2007) (enrolled sept. 17, 2007) (authorizing the development of mental health courts throughout the state of california on a county-by-county basis). 410 see torrey, surviving scmzophrenja, supra note 12, at 166-67 ("there are ancil­ lary benefits of hospitalization for persons with schizophrenia.''). 430 indiana health law review [vol. 4:361 of the illness. simple innovations in modern architecture are being used by several state hospitals around the country to improve the environment of inpa­ tient hospitals. 411 these developments include providing natural light, gardens, and murals to make the hospitals feel more like boarding school rather than the cold and sterile institutions of the past.412 an additional advantage to inpatient hospitals is that they are fully staffed, and often provide patients with access to libraries, vocational programs, art classes, socials, gym class, outdoor space, gardens, dental and medical treatment, music therapy, or general psychosocial treatment.413 additional funding to strengthen these programs could prove beneficial, particularly for those states that do not have pvot or aot.414 by contrast, the indiana state government is leading a movement to privatize its state hospitals that may someday reduce the number of hospitals in the state, leaving many severely mentally ill by the wayside. 415 if a movement to increase inpatient services is any kind of option worth considering, pressure needs to be placed on the federal government to repeal the medicaid exclusion for coverage 411 e.g., evansville state hospital, evansville, ind. (opened in 2003). ind. fam. & soc. servs. admin., news media advisory: state officials to dedicate new evansville state hospi­ tal on wednesday, aug. 25, 2003 ("the new hospital will provide modem, up-to-date quarters for patients with severe mental illness who need residential treatment. the treatment facility will ... feel as little like an institution as possible. nurses will monitor natural daylight in the building, and an elongated skylight over the therapeutic "treatment mall" will assure that the new space is bright, airy and non-institutional.") (on file with author). 412 ind. fam. & soc. servs. admin., new evansville state hospital: fast facts ("some of the special architectural features in this facility include natural lighting, nature views, home--like settings, therapeutic color definition, visibility and security.") (architectural design by veazey parrott durkin & shoulders) (on file with author). see also gene bunnell, the importance of comprehensive planning for the reuse of mental hospital properties: lessons learned in massachusetts and connecticut, in changing places: remaking institutional buildings 224-25, 242 (lynda h. schneeldoth, marcia f. feuerstein & barbara a. campagna eds., 1992) ("far too many buildings at state mental hospitals have been allowed to deteriorate as a result of long term disuse and neglect. what has been lacking to-date, and what is desperately needed, is a positive vision of the contemporary possibilities .... to significantly improve and upgrade the facilities for the treatment of the mentally ill .... redevelopment and reuse needs to overcome the social and physical isolation which has helped to stigmatize state mental hospital properties. planning can help accomplish this by increasing physical connections and social interaction between hospital properties and their surrounding communities."). 413 interview with brian k. newell, librarian, logansport state hospital, logansport, ind. (june 2006). e.g., torrey, surviving schizophrenia, supra note 12, at 167; contra saks, refusing care, supra note 18, at 54 ("most hospital wards are locked, so there is drasti­ cally reduced freedom of movement. ... opportunities for education and recreation may be limited.") 414 treatment advoc. crr., assisted outpatient treatment, supra note 21, at 1 (citing connecticut, maine, maryland, massachusetts, new jersey, new mexico, nevada, and tennessee as the eight states that do not have any form of aot whatsoever). note that in sev­ eral of these states aot legislation is currently pending. see supra part vi.b (discussing legis­ lative aot bills in new mexico, tennessee, and new jersey). 415 see mary beth schneider, hospital plans questioned, indianapous star, oct. 13, 2005, at 5b. 2007] towarda twenty-firstcenturycivilcommitmentstatute 431 in such hospitals.416 nonetheless, possibly we should have less fear when we think of"inpatient hospitalization" and maybe it·is worth considering ways to expand these programs to genuinely improve the care of our severely mentally ill. c. improving awareness and education of severe mental lllness through early prevention "australia offers an interesting counterpoint to canadian and american thinking with respect to the care and treatment of chronically dangerous and mentally ill persons.'o417 while prevention of severe mental illness is still the focus, australia aims to diagnose mental illness at a much earlier stage, ideally in childhood or adolescence.418 [t]he mechanism used to decrease violent behavior in mentally ill individuals is not to commit them to outpa­ tient treatment based on a history of dangerousness but, rather, to identify potentially dangerously mentally ill persons as early as possible ... and [to] provide imme­ diate, individualized psychiatric intervention in the community.419 initiatives such as school screening, child health and court support services, specific programs for early psychosis intervention, and relapse management plans all play a role in detecting early warning signs of severe mental illness, and fostering timely outpatient intervention in the development of mental ill­ ness.420 this community-based approach stresses the importance of early inter­ vention for people who are developing, or who are at a high risk of developing, mental health problems or mental disorders in order to minimize the potentially debilitating effects of these conditions.421 although early intervention is critical for successful treatment, one poten­ tial flaw of the system is considering that the onset ofmany severe mental ill­ nesses is in adulthood.422 nonetheless, a combination of addressing mental health at early stages in addition to pvot statutes may be the ideal setting for an effective mental health care system of the future. 423 416 davoli, supra note 9, at 162. 417 cornwell & deeney, supra note 3, at 231. 418 id 419 id. 420 id. at 232. 421 id. at231-32. 422 cf. torrey, surviving scmzophrenia, supra note 12, at 99-101 (describing child­ hood, postpartum, and late-onset schizophrenia). 423 the early screening mechanism. however, may present some questionable constitu432 indiana heal til law review [vol. 4:361 an additional difference between the australian policy and the american approach is that the concept of a court order appears to be absent from the community initiative program.424 this is because the goal is to prevent men­ tally ill individuals from reaching a heightened state of deterioration. while the australian approach might be a greater intrusion on civil liberties, an indirect benefit is that the public becomes better educated about mental illness by mak­ ing intervention initiatives a part of mainstream community health and educa­ tion policies.425 it remains to be seen whether early identification of and treatment for individuals at risk of developing a severe mental illness will lead such individuals to use outpatient psychiatric services more efficiently.426 d. comprehensive voluntary services programs· california recently introduced the mental health services act that pro­ poses a variety of methods for reforming the care of severely mentally ill per­ sons through voluntary services. 427 the first critical aspect of this statute is the generous provisions of financing, which has been secured with proposition 63.428 without financial resources, a state has little prospects for reforming a mental health services delivery system. but with appropriate funding, expan­ sions and improvements are currently being made in 1) education and training programs, 2) innovative programs; 3) prevention and early intervention pro­ grams; 4) oversight and accountability; and 5) children's services.429 the men­ tal health services act, however, is focused primarily on improving voluntary rather than involuntary treatment programs.430 some might argue that the focus on improving voluntary services is inconsistent with current scientific and medical data regarding the lack of insight among the severely mentally ill.431 proponents, however, would counter that as voluntary services are expanded and improved, the need for involuntary services will greatly decrease. tional issues in the united states; in particular, whether such screening is an unlawful search and seizure under the fourth amendment. but cf bd. ofeduc. v. earls. 536 u.s. 832, 837 (2002) (holding that a middle school and high school policy of drug testing in order to partici­ pate in extracurricular activities was a reasonable search). 424 see cornwell & deeney, supra note 3, at 231-32. 425 see id at 232. 426 ld. ''whether such a restructuring of mental health services could ever be accom­ plished broadly in this country is open to serious question. in the meantime, we should support [pvot] at home while keeping a watchful eye on developments down under." id. 427 this may include the implementation of mental health courts at the superior court level for mentally ill criminal offenders in the near future. see s.b. 851,2007-08 leg., reg. sess. (cal. 2007). 428 see supra notes 398-400 and accompanying text. 429 see cal. welf. & inst. code§§ 5820, 5830, 5840, 5845, 5851 (west supp. 2007); see also § 5890. 43° cal. welf. & inst. code§ 5801(bx5). 431 see supra notes 74-77 and accompanying text. 2007) toward a twenty-first century civil commitment statute 433 xi. conclusion there are many approaches to reforming the system of caring for the se­ verely mentally ill. pvot presents just one recent and promising option. while pvot offers substantial improvement to a broken mental health system, there are at least two noticeable drawbacks, given the goal of shifting toward a more medically-based model of civil commitment. first, pvot statutes are less likely to help young adults beginning to de­ velop a severe mental illness. this is because of their policy preference to ex­ clude data from the most recent six months and the corresponding lack of a concrete history of severe mental illness for this age group. sadly, science and medicine tell us that the earlier treatment is administered for severe mental ill­ ness, the more likely successful long-term recovery will occur.432 pvot does not seem to be achieving this goal for this population. second, in order to be eligible for pvot, pvot statutes require at least two instances of psychiatric hospitalization or receipt of forced medication in an incarceration setting.433 there are several sub-populations of severely mentally ill individuals who easily may not meet this demanding criterion. robert gil­ more-the individual who has been severely mentally ill and homeless for twenty years with forty arrests-may be one of them.434 additionally, non­ violent severely mentally ill persons who may be less prone to arrest or civil commitment under the danger-or-grave-disability statutes may also be over­ looked. despite these drawbacks, for states without any aot of any kind, pvot is a great stride toward updating and improving their mental health care sys­ tems. in particular, pvot provides a more sustained and lengthy treatment period (at least six months) that helps many severely mentally ill persons better adhere to their treatment plans, which greatly improves their chances oflong­ term recovery. furthermore, statistical studies such as in new york's final report on kendra's law provide concrete support that pvot is an effective way to treat the chronically and severely mentally ill. this evidence should serve as a solid foundation for additional pvot research, ideally through the adoption and implementation ofpvot in other states. while it might be several decades before more pvot studies are accumu­ lated to reach a more definitive conclusion regarding the effectiveness of these statutes, there is no reason to doubt the successes that the new york report identifies. new york city is hardly a trivial or mere experimental case. home­ lessness, criminalization, victimization, and violence against and by the se­ verely mentally ill have been dramatically reduced in new york apparently due 432 see supra note 1 06 and accompanying text 433 see supra part v.a.l. 434 see supra part iv and notes 155-57 and accompanying text. 434 indiana health law review [vol. 4:361 to the adoption of kendra's law.435 as of now, the new york report is sub­ stantial evidence that pvot can be successful in states and counties that enact and implement it. further, the new york court of appeals' decision, in re k.l., suggests thatpvotwould likely be upheld by the united states supreme court or other state supreme courts as a constitutional exercise of state power.436 states without pvot statutes in place should strongly consider adopting them. kendra's law, laura's law, and the pvot laws offlorida and michi­ gan provide good models of prominent pvot statutes, and include various op­ tional policy positions to choose from, upon which states may draw. ·sunset provisions, however, are probably a good idea until more concrete data have accumulated concerning the effectiveness ofpvot. like the movement of the 1950s and 1960s that motivated the danger statutes, the pvot movement of the twenty-first century marks the evolution of a new type of statute that seeks to aid the severely mentally ill through a more medically-based model. as medical understanding of severe mental illness im­ proves, psychiatric treatments continue to advance in sophistication, and our society begins to better appreciate the seriousness of severe mental illness, the laws that protect our severely mentally ill should reflect that change. 435 see supra notes 300-01, 314 and accompanying text. 436 see supra notes 219-29 and accompanying text. get "hip" america: using the "healthy indiana plan" as a model for decreasing the number of uninsured americans one state at a time barbara e. molargik:-fitch * i. injr.oduction ................................................................................. 58 a. the issue .................................................................................... 59 b. the roadmap ........... .................................................................. 60 11. background and features of the heal thy indiana plan ... 60 a. the passage and objectives of hea 1678 ....... .......................... 60 b. details of hip ............................................................................ 62 1. qualif.yingfor hip ............................................................... 62 2. funding hip ........................................................................ 63 3. hip's coverage .................................................................. 65 a. high-deductible coverage ............................................ 65 b. po'wer account ........................................................... 66 c. preventative health care ............................................... 66 4. hip's insurers ..................................................................... 67 5. the buy-in option ............................................................... 68 iii. hip's model offers a more sustainable route than national health care proposals to achieve the goal of insuring more americans ........................................................... 69 a. the national health care plans ................................................ 69 1. the united states insurance act of 2008 ............................ 69 2. the obama reform bill ....................................................... 70 b. hip's unique, realistic and sustainable nature ....................... 72 iv. hip is a model for many other states struggling to insure their citizens ................................................................... 73 a. hip is a model for other states ................................................ 73 b. unsuccessful state plans ........................................................... 74 1. the california plan ............................................................. 74 2. the wisconsin plan ............................................................. 75 3. the massachusetts plan ...................................................... 75 4. the washington plan .......................................................... 77 5. the maine plan ................................................................... 78 c. plans similar to hip and based on individual choice and market competition ................................................................... 79 1. the florida plan ................................................................. 79 2. the georgia plan ................................................................ 80 d. hip offers something to build on ............................................ 81 * j.d. candidate, 2010, indiana university school of law-indianapolis; b.a., 2007, indiana university-bloomington. 58 indiana health law review [vol. 7:57 v. on-site health care clinics offer additional means for insuring more americans by decreasing the costs state governments must pay in health care expenses ................. 82 a. novia careclinics,llc. ("novia''), indianapolis, indiana ....... 83 b. carehere, uc., central tennessee .......................................... 85 vi. conclusion ..................................................................................... 86 "i ... hope other states will follow indiana's model of combining personal responsibility with public sup­ port to help those who are truly in need gain health coverage. "1 -u.s. department of health and human services secretary mike leavitt i. introduction one august afternoon ms. tammy chandler carried her fifteen-day­ old son to the ambulatory care center in huntsville, alabama for a check­ up.2 while at the care center, ms. chandler was instructed to take her new­ born infant to the hospital for emergency care immediately.3 upon arriving at the hospital, the uninsured, distressed mother "was asked if she had either insurance or $54 for the emergency room admission fee.'"' ms. chandler had neither. as a result of her indigence, ms. chandler was told that her son could not be seen. 5 a nurse at the hospital instructed her to go home and to give her sick infant tylenol and a warm bath. 6 later that evening, however, ms. chandler returned to the hospital, once again, with her se­ riously ill child.7 three hours later the infant was finally seen by a doctor. unfortunately, because of the delayed medical treatment, the infant died from spinal meningitis the next day.8 spinal meningitis, "an inflammation of the membranes that cover the brain and spinal cord," is a potentially fatal disease if not immediately treated with ingestion of antibiotics.9 1. press release, u.s. dept. of health & human services, hhs approves medicaid waiver to create new indiana health plan for uninsured hoosiers (dec. 14, 2007), availa­ ble at http://www.dhhs.gov/news/press/2007pres/12/20071214a.html (hereinafter "press release") 1989). 2. chandler v. hospital authority of city of huntsville, 548 so. 2d 1384, 1385 (ala. 3. !d. 4. 1d 5. ld 6.·ld. 7. id. 8. chandler, 548 so.2d at 1385. 9. u.s. dept. of health & human services, centers for disease control & preven­ tion, meningitis questions & answers, http://www.cdc.gov/meningitis/about/faq.html (last 2010] get "hip" america 59 a. thelssue the issue of health care coverage locally and nationally is not new. in 2007, over 717,000 of indiana's 6.26 million hoosiers were without health insurance.10 the healthy indiana plan (''illp") was created to address the issue of health care coverage in indiana, especially with regard to low in.;. come individuals like ms. chandler. illp is vital for indiana citizens, espe­ cially during times of economic downturn when indiana citizens are losing health care coverage, particularly employer-sponsored health insurance. the percentage of hoosiers covered by their employers'. health care plans is dropping substantially. in fact, employer-sponsored health care plans "cov­ ered 70.5 percent of indiana's under 65 population'' in 2007.11 that was a substantial drop from the 75.7 percent employer-sponsored health care in 2001.12 moreover, in the past few years, the entire country has been expe­ riencing economic hardship. the number of people covered by employer­ sponsored health care in 2007 was 59.3 percent, which was a decrease from 59.7 percent in 2006.13 "this continues a trend of decreasing employer sponsored coverage since 2000."14 furthermore, many states are expe­ riencing a similar situation as in indiana, where employers are eliminating health care plans. for example, in minnesota fewer businesses provided health care coverage from 2001 to 2004, thus increasing the rate of unin­ sured residents from 5.4 percent in 2001 to 6.7 percent in 2004.15 addition­ ally, looking at health care coverage overall, ten states had lower 2-year­ average uninsured rates for 2006-2007 than their 2-year-average rates for 2004-2005.16 these states, along with their increase in uninsured,:include~ kansas (+2.0), kentucky (+1.6), louisiana (+3.3), mississippi (+3.0), ne­ braska (+2.3), new jersey (+1.4), new mexico (+2.6), new york (+0.8), north carolina (+2.1), and texas (+0.9)!7 many states could use illp as a model to develop an affordable health care plan that will help insure niore of their citizens during this time of recession. visited jan. 6, 2010). 10. daniel lee, fewer hoosiers were uninsured in 2007: numbers down nationally, too; experts cite expansion of government programs, the indianapolis star, august 27, 2008, at b08. 11. report: hoosiers losing health insurance, goshen news, oct. 14, 2008, http://www.goshennews.com/archivesearcmocal_story_287105844.html (hereinafter "los­ ing health insurance"). 12. /d. 13. carman denavas-walt, bernadette d. proctor & jessica smith, income, poverty, and health insurance coverage in the united states: 2007, u.s. census bureau at 19 (2008}, available at http:/ /www.census.gov/prod/2008pubs/p60-235.pdf. 14. robert wood johnson foundation, state coverage initiatives: who's uninsured? http:/ /www.statecoverage.org/node/18# _ ftn1. 15. state's uninsured rate rises, m employers drop coverage, mlnneapousist. paul bus. j., feb. 25, 2005, http://twincities.bizjoumals.com/twincitieslstories/2005/02/21 /daily49.html. ' 16. denavas-walt, supra, note l3 at 26. 17. ld. 60 indiana health law review [vol. 7:57 as explained herein, a realistic approach to substantially reducing the number of uninsured americans nationwide is to offer health insurance coverage on a state-by-state basis which is based on market competition, personal responsibility, wellness, and public support, while also demanding a modest income-based premium. such a plan makes it possible to insure more americans while also being cost-efficient. if each state raises money to support its plan and crafts the plan to the very needs of its own citizens, like hip, health care coverage for more americans will be a more sustaina­ ble and affordable goal. additionally, if each year states add new innova­ tive aspects to their state plans to save money each year, and if those states continue to build on their plans annually to make them better, more ameri­ cans will be insured each year. on-site health care clinics, discussed in par­ ty v of this note, exemplify an innovative feature which states may add to their health care plans and to their government agencies to save on health care costs. b. the roadmap this note discusses how hip offers a health care model for other states struggling to provide health insurance for their citizens. in order to fully understand hip's makeup and coverage, section ii of this note dis­ cusses the background of hip. section iii focuses on why hip is a more sustainable model for decreasing the number of uninsured americans than other federal health care plans that have been proposed or are currently be­ ing enacted. section iv argues that hip is a model for many other states that are struggling to insure their citizens by comparing hip to state plans that have failed as well as state plans similar to hip that are currently expe­ riencing success. finally, section v takes a step into the future and dis­ cusses how adding "on-site" health care clinics to state health care plans and state governments may offer additional means for insuring more americans by decreasing the overhead costs state governments must pay out in medi­ cal-related expenses. ii. background and features of tile healthy indiana plan a. the passage and objectives of hea 1678 hip, also known as the indiana check up plan, was introduced and passed by the indiana general assembly in april 2007 as part of the house enrolled act no. 1678, public law 218-2007 ("hea 1678").18 the stated 18. family and social services administration, a check up on the indiana check-up plan: hea 1678, slide 16 (sept. 30, 2008) http://www.in.gov/fssalhip/files /indianacheckupplan.pdf (last visited april 8, 2010) (hereinafter "a check up"); indiana house of representatives house democrats, indiana check up plan, http://www.ai.org 2010] get "hip" america 61 objective behind enacting hea 1678 was to "advance health care policy in indiana ... and [to] reduce the state's high rate of smoking."19 when con­ sidering the passage of hea 1678, the indiana legislature was encouraged to reform its health care policy because of the alarming fact that indiana had the second highest drop in employer-sponsored health insurance between 1999 and 2004.20 since 1990, the uninsured population has increased by approximately 30 percent in indiana.21 additionally, hoosiers had the second highest rate of smoking in 2008 (26% ), 22 eighteenth highest rate of obesity in 2008 (63.5%),23 and fourteenth highest rate of stroke and other cerebrovascular diseases in 2006 (49.0%).24 to address these problems, the legislature enacted hea 1678 to provide for various health care policy im­ provements. some of the health care highlights ofhea include: 25 • tax credits related to small employer qualified wellness pro­ grams; • an increase in cigarette tax by 44 cents per pack to fund vari­ ous health related expenses; • tax credits for employers for making a health benefit plan available to employees for the first two taxable years the health benefit plan available; • an increase in the income limit for medicaid eligibility for pregnant women; • continuous eligibility of a child under medicaid and the children's health insurance program (chip) until the child /legislativelhouse_democrats/indiana_checkup_plan.html (last visited feb. 9, 2009). 19. governor signs healthy indiana bill, inside indiana bus., may 11, 2007, http://www.insideindianabusiness.com/newsitem.asp?id=23285. 20. the iowa legislature general assembly, the healthy indiana plan house enrolled act 1678, slide 9 (2007) http://www.in.gov/fssa/hip/filesllndianacheckupplan.pdf. 21. id. 22. kaiser family foundation-statehealthfacts.org, percent of adults who smoke (2008) http://www.statehealthfacts.org/comparemaptable.jsp?ind=80&cat=2&sort=a (last visited jan. 8, 2010). the kaiser family foundation is a non-profit and private operating foundation that focuses primarily on the major health care issues facing the u.s. and abroad. "kaiser develops and runs its own research and communications programs, sometimes in partnership with other non-profit research organizations or major media companies," such as npr or the harvard school of public health. additionally, kaiser "serves as a non-partisan source of facts, information, and analysis for policymakers, the media, the health care com­ munity, and the public." kaiser family foundation, about us, http://www.kff.org/about /index2.cfm (last visited jan. 8, 2010). 23. kaiser family foundation-statehealthfacts.org, percent of adults who are over­ weight or obese (2009) http://www.statehealthfacts.org/comparemaptable.jsp?ind=89&cat= 2&sort=a (last visited jan. 8, 2010). 24. kaiser family foundation-statehealthfacts.org, number of deaths caused by stroke and other cerebrovascular diseases (2006), http://www.statehealthfacts.org /comparemaptable.jsp?ind= 122&cat=2&sort=a. 25. legislative services agency, digest of hb 1678 (2007}, http://www.in.gov /appsllsalsessionlbillwatchlbillinfo?year=2007&request--getbill&docno=1678. 62 indiana health law review [vol. 7:57 becomes three years of age; .,. establishment of the indiana check-up plan (plan) [aka healthy indiana plan] and the indiana check-up plan trust fund; • requirements for· the state department of health to establish · standards for and certify a small employer qualified wellness program; • · requirements for health insurers and health maintenance or­ ganizations to cover children up to 24 years old upon request; ·• provisions· certain small employers to join together to pur­ chase group health insurance and allows the insurance com­ missioner and the office of the secretary of family and social services to develop a program to provide for such purchases; • requirements that the indiana comprehensive health insurance association administer plan benefits for high risk individuals · · insured under the plan; ., requirements for applications for necessary federal medicaid approvals, including approval for presumptive eligibility for certain pregnant women and implementation of the plan; • establishments of a plan task force; requirements for the health finance commission to study and report concerning several issues; •· and an allowance of appropriations for the act. hip is one of the many health care highlights included in hea 1678. after hip was passed in april 2007, the plan was quickly implemented. in august 2007, health insurance plans were selected for hip (anthem and md wise), and in november 2007, a contract was signed with the health plan carriers. 26 in december 2007, insurance carriers began accepting ap­ plications for hip.27 finally, on january 1, 2008 hip was fully imple­ mented. 28 at that time, almost 7,000 applications have been received. 29 b. details of hip 1~ qualifying/or hip to qualify for hip, individuals must be uninsured for at least 6 months and cannot be eligible for employer-sponsored health insurance, 26. nat'l governor's association. healthy indiana plan, slide 22, (2008) http:// ww'w.nga.org!fileslpdf70803healthreformcollisi.pdf . . 27 . . .jd . . 28. /d. 29. id 2010] get "idp" america 63 medicare, or regular medicaid. 30 hip offers insurance to uninsured adult hoosiers who are between the ages of 19 and 64 whose household incomes are between 22 and 2000/o of the federal poverty level ("fpl").31 this range is equivalent to approximately "$3,872 to $35,200 per year for a fam­ ily of three in 2008."32 hoosiers with incomes above 200% of the fpl are not eligible for hip. they may, however, be eligible for the buy-in option explained in section ii(b)(5) of this note. these requirements are intended to discourage insured hoosiers from dropping their plans to join hip, in the hope of preventing the plan from being overburdened with applicants. they also serve to discourage employers from dropping their plans so that their employees will join hip. hip cannot support every hoosier; it was not built for universal-type coverage. 2. funding hip one provision ofhea 1678 provides for an increase in cigarette taxes by 44 cents per pack to help finance hip.33 consequently, the cigarette tax increased from $.555 to $.995 per pack as of july 2, 2007.34 since august 1, 2007, 27.05% of the money made from the cigarette tax has been dis­ persed to the hip trust fund. 35 this increase in cigarette tax is expected to lower the number of young smokers by approximately 40,000, and the number of adult smokers by approximately 23,400.36 in states that have high numbers of cigarette smokers, increasing the cigarette tax is one way to decrease the number of smokers, especially young smokers, while simul­ taneously funding a health care plan. moreover, those individuals who smoke less or quit smoking altogeth­ er will be healthier and will require less medical attention and treatment. less overall treatment decreases total medical expenses and opens up addi­ tional funds for insuring more people. after all, in 1998, smoking-related 30. family & social services administration., hip: about the plan, http://www.in.gov /fssalhip/2344.htm (last visited sept. 10, 2008) (hereinafter" about the plan"). 31. family & social services administration, healthy indiana plan: frequently asked questions, http://www.in.gov/fssalhip/ (last visited oct. 25, 2008) (hereinafter "faqs"). 32. kaiser commission on medicaid facts, summary of healthy indiana plan: key facts and issues (2008),at 2, http://www.kff.org/medicaid/upload/7786.pdf. 33. healthy indiana plan th,e issue: state launches coverage for low-income hoosi­ ers. our view: program could bring improved health to thousands, ev ansvu..le courier & press, january 2, 2008, ·available at http://www.courierpress.com/news/2008/jan/02 /healthy-indiana-plan-the-issue-state-launches-to/. 34. lawrence jegen, recent developments in indiana taxation, 41 ind. l. rev. 1271, 1291 (2008). 35. /d. 36. "healthy indiana plan" to go live in january, health care financial management, october 2007, available at http://findarticles.com/p/articleslmi_m3257 /is_l0_6llai_n21040136/. (health care financial management is the "[o]fficial magazine of the health care financial management association. features the latest industry news for ~cial managers in all segments of the health care industry.) 64 indiana health law review [vol. 7:57 health care costs in the united states were approximately $75.5 billion.37 "for each of the approximately 46.5 million adult smokers in 1999[,] these costs represented an annual cost of ... $1 [,]623 in excess medical expendi­ tures in addition to the ... $ 1[,]760 in lost productivity."38 decreasing the number of smokers would substantially trim this number especially consi­ dering "[h ]ealth care costs for smokers at a given age are as much as 40 per­ cent higher than those for nonsmokers."39 in addition, hip collects low premiums from those insured by hip. for example, a single adult with no children and an income ranging from $0 to $10,200 would pay $0 to $204 a year.40 a family of four with an income of $0 to $20,650 would pay $0 to $413 annually.41 collecting these low premiums helps make the funding of hip more manageable. furthermore, the sliding scale used to determine the premiums is appropriate because those individuals who do not have jobs, such as students, can still obtain health care coverage without paying premiums they cannot afford. some hoosiers who do have an income, however, must contribute not more than 5 percent of their income to the plan to help offset expenses. 42 this helps make hip affordable and possible. furthermore, hip is operated under § 1115 of the medicaid waiver program and, thus, must be budget-neutral to the federal government. 43 the details of this waiver, which have been approved by the department of health & human services, are as follows: in december 2007, indiana received federal approval for a medicaid waiver to implement the healthy indi­ ana plan. under the plan, indiana is using medicaid funds to provide a benefit package modeled after a high-deductible heath plan and health savings account to previously uninsured very poor and low-income adults. most enrollees are covered through managed care plans; those with certain high-risk medical condi­ tions are covered through a separate fee-for-service plan. the waiver was approved for five years, from 37. world health organization, tobacco and poverty a vicious circle (2004), at 5, available at http://www.ingcat.org/linked%20files/poverty_en.pdf (citing dept. of health & human services, centers for disease control and prevention, annual smoking-attributable . mortality, years of potential life lost, and economic costs-united states, 1995-1999,51 morbidity and mortality weekly report, 300-3 (2002)). 38. world health organization. supra note 37, at 5. 39. jan j. barendregt, luc bonneux, & paul j. van der maas, the health care costs of smoking, 337 theneweng.j. med.1052, 1052 (1997). 40. faqs, supra note 31, at 10. 41. /d. at 11. according to fssa data, a family of four consists of two adults and two children. id. 42. faqs, supra note 31, at 3. 43. kaiser commission on medicaid facts, supra note 32, at 6. 2010] get "hip" america 65 january 1, 2008-december 31,2012.44 during the five-year waiver period, hip "cannot cost the federal govern­ ment more than would have been spent without the waiver.'"'5 to assure this requirement is met, a per capita cap on federal funds was established, "which limits the amount of federal funds the state can receive for people covered under the waiver based on pre-set per person costs and annual growth rate.'m indiana plans to offset the costs of expanding coverage by using a por­ tion of its disproportionate share hospital funds.47 also, the state plans to save "in its existing medicaid coverage for pregnant women, children, and parents. '"'8 to ensure budget neutrality is achieved, "the federal govern­ ment established a per capita cap on federal funds for healthy indiana plan expansion enrollees as well as pregnant women, children, and parents cov­ ered through medicaid.'"'9 additionally, indiana has agreed to achieve fur­ ther savings of $15 million over the five-year waiver period for which hip was approved. 50 this feature of hip aids indiana in maintaining a budget and prevents the risk of serious financial harm to the state treasury. 3. hip's coverage hip's benefits basically consist of three parts provided through ma­ naged care plans.51 these three components include: high-deductible cov­ erage, a power account, and preventative health care. a. high-deductible coverage first, hip provides high-deductible coverage. 52 after meeting a $1,100 deductible, individuals are covered up to $300,000 a year and up to 44. id 45. id 46. id 47. id. see also u.s. dept. of health & human services, analysis of the joint distri­ bution of disproportionate share hospital payments, http://aspe.hhs.gov/health/reports/02 /dsh/execsum.htm#introduction, ("the medicare and medicaid programs distribute extra payments to hospitals that treat a disproportionate share of indigent patients. the dispropor­ tionate share hospital (dsh) payment policies differ substantially between the two programs and, under medicaid, across states as well. nevertheless, the general objectives of each pro-­ gram are the same: to support the hospitals that are crucial to the health care safety net, and to preserve access to these hospitals for the respective program's enrollees.") 48. kaiser commission on medicaid facts, supra note 32, at 6. 49. id. at l. 50. id at6. 51. id. at 3. 52. id. 66 indiana health law review [vol. 7:57 $1 million in a lifetime for state-specified benefits. 53 upon meeting this deductible, individuals receive coverage for state-specified benefits, which include "inpatient and outpatient care, physician care, prescription drugs, home health care, and mental health care up to the caps."54 hip does not, however, cover dental or vision care nor does it cover long-term skilled nursing care or pregnancy-related services. 55 b. power account the second component of hip is its personal wellness and responsi­ bility (power) account feature.56 this account is hip's ''version of a health savings account (hsa) and is used to cover the $1,100 deducti­ ble."57 the power account is funded by the enrollee or enrollee's em­ ployer, the state government, and the federal government and is administered by the enrollee's managed care plan. 58 the power account helps individuals pay for basic health services, such as regular doctor visits. participants may make contributions to their power accounts by check or money order, automatic bank draft, credit card, cash or through an employer contribution. 59 however, failure of an individual to make the power ac­ count contribution within 60 days will result in one of the following: (1) losing the coverage from hip; (2) losing the chance to see an individual's doctor; (3) being removed from the hip plan and having a portion of one's contribution returned; or ( 4) waiting twelve months to reapply for the hip plan.60 c. preventative health care finally, hip encourages preventative care.61 indiana requires partici­ pating care plans to cover up to $500 in preventative care each year.62 pre­ ventative care is "not subject to the deductible and does not draw from the power account.'.63 additionally, with hip coverage, "[p ]arents are 53. kaiser commission on medicaid facts, supra note 32, at 3. 54. id. 55. /d. 56. /d. 57. id. 58. /d. 59. family & social services administration, healthy indiana plan: health plan summary, http://www.in.gov/fssa/hip/files!maxi542 _in_ hip-planchartdec20.pdf (last visited february 8, 2009) (hereinafter "health plan summary"). 60. kaiser commission on medicaid facts, supra note 32, at 5; mdwise, power ac­ count, http://www.mdwise.org/hip/members/poweraccount/ (last visited feb. 19, 2009) [nt a: the mdwise website is not accessible. consider eliminating this citation]. 61. kaiser commission on medicaid facts, supra note 32, at 3. 62. id 63. /d. 2010] get"hip"amer!ca 67 charged between $3 and $25 for an· emergency room visit," emergency room fees being based on a parent's income.64 "[c]hildless adults are charged $25 per visit" without consideration of income. 65 4. hip's insurers hip has two health care insurers: mdwise (partnering with amen­ choice) and anthem blue cross and blue shield ("anthem").66 the mdwise coverage is an extension of its hoosier healthwise participating provider agreement. 67 characteristics of the md wise agreement with hip include, but are not limited to the following: $25 co-pays for emergency room care for childless adults; emergency room care (for non-emergency services) based on family income level of adults with children; multiple power account methods of payment; care management services; disease management programs; enhanced services such as free unlimited preventa­ tive care services and free over-the-counter medicines; assistance with community resources and other needs; and educational programs. 68 the anthem agreement is an attachment to its anthem blue cross and blue shield provider· agreement and an amendment to the anthem blue cross and blue shield professional provider agreement.69 this plan in­ cludes the following characteristics: $25 co-pays for emergency room visits for childless adults; emergency room (for non-emergency services) visits for adults with children requiring a co-pay amount based on family income level; multiple power account methods of payment; care management services; disease management programs; 70 community resource centers; and educational programs.71 enrollees of hip must select a health care plan at the time of applica64. id at 3-4. 65. id. at4. 66. healthy indiana plan (hip) resource center, http://www.ismanet.org/hip.httn (last visited sept. 10, 2008) (hereinafter "hip resource center''). 67. id.; welcome to the hoosier healthwise website (2007) http://www.healthcareforhoosiers.com/index.html. (''the hoosier healthwise program is a health ( )care program for low income families, pregnant women, and children. it is spon­ sored by the state of indiana through family and social services administration. the pro­ gram covers such medical care as doctor visits, prescription drugs, mental health( )care, dental care, hospitalizations, surgeries, and family planning at little or no cost.") 68. health plan summary, supra note 59. 69. hip resource center, supra note 66. 70. health plan summary, supra note 59. 71. id. (hip offers educational programs such as: ''new member education meetings at locations throughout the state[;] online health risk assessments [that] help [] [individu­ als] improve [their] health and give[] [them] a $50 gift card for completion;;] personalized telephone based weight management program[s that] help[] [individuals] lose or gain weight, or stay at a healthy weight[;] tobacco treattnent program[s that] help[] [individuals] learn new behaviors, offers nicotine replacement gum and patches[; and] health coach pro­ grams [that] offer telephone coaching sessions for certain health conditions.") 68 indiana health law review [vol. 7:57 tion, otherwise the state will assign a plan upon approval. 72 once enrollees are approved and are assigned a plan, they must stay on that plan for 12 months.73 as of june 2008, approximately 74 percent of enrollees chose the anthem plan and approximately 24 percent chose mdwise.74 5. the buy-in option another unique characteristic of hip is that it further permits a buy-in option for individuals and families who earn over 200% of the fpl. 75 the buy-in option also allows for employers to pay for a portion of their em­ ployees' health insurance.76 in fact, "[e]mployers who do not currently of­ fer any health plans oftheir own can pay up to 50 percent of the premiums for their employees who enroll in hip."77 furthermore, "[a]s with the sub­ sidized hip program, [hoosiers] accepted for the buy-in" option must also be uninsured for 6 months or more with no access to employer-sponsored health benefits. 78 when determining the premium rate for the buy-in op­ tion, an individual's age, health status, and gender.79 the policy also looks at an individual's weight and overall health condition.80 by way of exam­ ple, "[m]onthly premiums for a 25-year-old male are around $125, while a 60-year-old female would pay about $550 per month."81 additionally, the policy will cover some preexisting conditions. for example, it will cover diabetics who take pills only, but will not consider diabetics who take insulin.82 also, to even apply for the buy-in option, ap­ plicants must have applied for and have been denied by hip first. 83 addi­ tionally, according to fssa spokesperson elizabeth sergener, approximately "140,000 hoosiers are eligible for the hip expansion."84 as of august 2008, anthem is the only insurer participating in the buy-in op­ tion.85 mdwise is expected to also participate in the option in the near fu­ ture.s6 72. kaiser commission on medicaid facts, supra note 31, at 4 .. 73. ld. 74. /d. 75. faqs, supra note 31, at 2. 76. losing health insurance, supra note 11. 77. /d. 78. bruce goldfarb, account-based healthy indiana program expands with a buy-in option, ais's health bus. daily, aug. 5, 2008, http://www.aishealth.com/bnow /hbd080608.html (last visited 2009). 79. !d. 80. interview with sales representative, anthem blue cross & blue shield, sales hotline, at 1-800-622-4075 (dec. 30, 2008) (hereinafter "interview"). 81. goldfarb, supra note 78. 82. interview, supra note 80. 83. id 84. goldfarb, supra note 78. 85. !d. 86. /d. 2010] get ''hip., america 69 individuals who would otherwise qualify for hip may use the buy-in option if hip reaches its maximum capacity of enrollees. 87 in these in­ stances, the hip rates are available to such individuals, but the participants must pay the full costs. 88 the buy-in option has not been promoted as much as the other portions of hip have. it is, however, a unique part of the hip program that could prove very beneficial to many uninsured hoosiers. iii. hip's model offers a more sustainable route than national health care proposals to achieve the goal of insuring more americans over 47 million americans were uninsured in 2006.89 furthermore, "[h]ealth care costs are predicted to increase from $1.6 trillion in 2002 to $3.4trillion in 2013."90 many national health care plans have been pro­ posed to provide americans with access to health insurance and to address rising health care costs. however, a universal health care plan in the united states would likely be unsuccessful and would likely create a great financial burden on the country. it is questionable as to whether our country could sustain such an expensive plan for a long duration of time before it failed. in the early 1990s, congress rejected president clinton's universal health care plan because it would be too expensive to implement.91 as 2004 health and human services secretary tommy thompson stated, a univer­ sal health care plan is "'unrealistic. "'92 a. the national health care plans 1. the united states insurance act of 2008 the united states national health insurance act of 2008 intro­ duced in the house as h.r. 676 ("h.r. 676")93 "[e]stablishe[d] the united states national health insurance (usnhi) program (the program) to provide all individuals residing in the united states and in u.s. territories with free health[ ]care that includes all medically necessary care, such as primary care and prevention, prescription drugs, emergency care, and men87. a check up, supra note 18, at slide 15. 88. /d. 89. lee, supra note 10. 90. mark e. douglas. finally moving beyond the fiction: an overview of the recent state rally for health care reform, 5 ind.iiealm l. rev. 277, 280-1 (2008). 91. kristine nwazota, who should pay for health care, pbs, jan. 19, 2004, http://www.pbs.org/newshour/extra/features/jan-june041uninsured _1-19 .html. 92. /d. 93. united states national health insurance act (or the expanded and improved med­ icare for all act), h.r. 676, lloth cong. (2008), available at http://www.govtrack.us /congresslbill.x.pd?bill=h11 0-676&tab=summary (hereinafter "h.r. 676j. 70 indiana health law review [vol. 7:57 tal health services."94 the plan allows a participant to choose a doctor or facility within the network.95 h.r. 676, however, prohibits private health care insurers from providing coverage duplicative of benefits it provides.96 h.r. 676 allows private "insurers to sell benefits that are not medically ne­ cessary, such as cosmetic surgery benefits."97 allowing private insurers to provide coverage only for specific medical care may diminish the health insurance industry and may reduce the overall quality of health care cover­ age that is available to individuals. to finance the plan, h.r. 676 seeks to establish the usnhi trust fund.98 this trust collects funds from the following: "(1) existing sources of government revenues for health care; (2) [] increase[ ed] personal income taxes on the top 5% ofincome earners; (3) [] instituting a progressive excise tax on payroll and self-employment income; and (4) [] instituting a small tax on stock and bond transactions. "99 2. the obama reform bill another national health care plan, of which was proposed by and signed into law100 by president barack obama on march 23, 2010,101 is known in short as the "health care reform bill" ("reform bill").102 the reform bill is ''the most far-reaching health legislation since the creation of the medicare and medicaid programs."103 while the reform bill has been signed, additional changes will occur if a reconciliation bill is passed at a later time in addition to the reform bill. 104 the reform bill mandates that americans obtain health insurance by 2014 or they would be obligated to pay a penalty.105 for individuals, [t]he penalty would start at $95, or up to 1 percent of [one's] income, whichever is greater, and could rise to $695, or up to 2.5 percent of [one's] income, by 2016."106 "[f]amilies have a limit of $2,085.' 107 some individuals would 94. id 95. id. 96. id. 97. jd. 98. id 99. h.r. 676, supra note 93. 100. reform bill was signed into law as public law no: 111-148. see thomas (library of congress), h.r. 3590, major actions, http://thomas.ioc.gov/cgi-bin/bdquery /z?dlll :hr03590:@@@r (last visited march 31, 201 0) (hereinafter "major actions"). 101. major actions, supra note 100. 102. thomas (library of congress), h.r.3590, titles, http://thomas.loc.gov/cgi-bin lbdquery/z?d111 :hr03590:@@@t (last visited march 31, 2010). 103. phil galewitz, consumers guide to health reform, kaiser health news, march 23, 2010, http:/ /www.kaiserhealthnews.org/stories/20 1 0/march/22/consumers-guide--health­ reform.aspx =(hereinafter "consumers guide"). 104. id. 105. jd. 106. id. 2010] get "hip" america 71 be exempted from the individual mandate for financial hardship or religious beliefs or if they are american indians. 108 beginning in 2014, the state-federal program for the poor and disabled would be substantially increased, so that individuals with income less than 133 percent of the fpl, may be eligible for the medicaid program.109 indi­ viduals with income greater 133 percent of the fpl, may acquire govern­ ment subsidies to help pay for a private insurance plan 'that would be sold in the new state-based insurance marketplaces, called exchanges, slated to begin in 2014."110 these subsidies would be available for individuals and families making between 133 percent and 400 percent of the poverty lev­ el.tu furthermore, individuals with preexisting conditions would be able to obtain health insurance easier because "insurers would be barred from re­ jecting applicants based on health status" beginning in 2014 when the ex­ changes are operating. 112 during the transition period, there would be "a temporary high-risk insurance pool for people with medical problems who have been previously rejected by insurers and have been uninsured for at least [6] months."113 additionally, individuals younger than 26 would be able to stay on their parent's insurance plans as long as they are not offered health coverage at work.114 individuals over 65 would notice an improve­ ment in the medicare prescription-drug benefit.115 however, government funding of the medicare advantage, 116 "would be cut sharply starting in 20 11."117 this means that the 10 million individuals enrolled in medicare advantage would "lose extra benefits that many of the plans offer, such as free eyeglasses, hearing aids[,] and gym memberships."118 the reform bill would require firms with more than 50 employees to pay a fee of up to $2,000 per full-time employee if any of their workers got government-subsidized insurance coverage in the exchanges instead of from the employer. 119 the first 30 workers would not be included in the assess­ ment. 120 in contrast, companies with fewer than 50 workers would not face any penalties for not offering health insurance to its employees. 121 addi­ tionally, tax credits could be available to companies to help them buy insur107. jd. 108. id. 109. galewitz, supra note l 03. 110. id. 111. jd. 112. id. 113. id. 114. id. 115. galewitz, supra note 103. 116. jd. (medicare advantage is the private-plan part ofmedicare.) 117. galewitz,supranote 103. 118. jd. 119. jd. 120. jd. 121. ld. 72 indiana healm law review [vol. 7:57 ance if they have 25 or fewer employees and a workforce with an average wage up to $50,000.122 the reform bill will cost approximately $938 billion over the next 10 years123 and is expected to extend health care coverage to 32 million addi­ tional americans by 2019.124 those individuals with higher incomes will have to pay higher taxes.125 individuals earning more than $200,000 a year and couples earning more than $250,000 will pay a 2 percent higher medi­ care payroll tax which is up from the current 1.45% tax.126 furthermore, the reform bill will impose "a 40 percent excise tax on the portion of em­ ployer-sponsored health coverage (excluding dental and vision) that ex­ ceeds $10,200 a year for individuals and $27,500 for families."127 future health insurance premiums will be hard to predict are the subject of much debate in the passage of the reform bill.128 b. hip's unique, realistic and sustainable nature hip is different and more realistic to implement than h.r. 676 and the reform bill. hip is a more sustainable plan because it requires each par­ ticipant to make a modest income-based financial contribution and focuses on combining personal responsibility with public support. also, it does not abolish employer-sponsored health care benefits nor does it mandate indi­ viduals to obtain health insurance as do the national plans mentioned in part iii(a)(1) and (2) ofthis note. hip recognizes that insuring all indiana citi­ zens solely through hip coverage is not a realistic goal. gradually insuring hoosiers who cannot obtain insurance elsewhere, while also encouraging employers to keep their health care plans for their employees, is a more sus­ tainable route to increasing access to medical care. hip also "provides in­ centives for participants to stay healthy, be value and cost-conscious, and to utilize services in a cost-efficient manner."129 additionally, by taxing aha­ bit that is very destructive to health, indiana will be able to finance a health care plan while also discouraging smoking at the same time. also, instead of increasing income taxes for residents, as does the reform bill, hip re­ quires those insured by hip to pay an income-based premium. national health care sounds ideal initially. however, the reality is that if the government insures the entire country, which included approximately 307,212,123 people in 2009,130 the government may be forced to substitute 122. !d. 123. galewitz, supra note 103. 124. id 125. id 126. id 127. id. 128. id 129. faqs, supra note 31, at 1. 130. cia-the world factbook. the united states (july 2009), https://www.cia.gov 2010] get "hip" america 73 quality for quantity, and limit who and where citizens may choose to obtain health care. also, by substituting quality for quantity, many health care professionals, such as specialists, may struggle to stay in business. special­ ists are more expensive, and a national health care plan may wish to curtail spending for specialists even though specialist care is often critical for re­ ceiving proper health care. the reform bill has numerous positive aspects such as barring insur­ ance companies from denying coverage based on preexisting conditions. nevertheless, the plan is expensive as it will cost approximately $938 bil­ lion over 10 years to make the health care reforms it projects to make. 131 the reform bill also seeks to mandate the entire country to obtain health insurance, penalizing those who do not obtain insurance, rather than look­ ing at the various needs of individual states. instead, the majority of health care decision making should be left to the states, because they are in a better place to individually address the issue of financing and creating health care programs within their borders. for example, if a state has a high rate of alcoholism, drunk drivers, and underage drinkers, it could increase the tax on alcohol. if a state has experienced a rapid increase in the number of ca­ sinos being built within its borders, it could capitalize on this expanding industry and increase the tax on the winnings at such casinos. each state is different and has different needs. these innovative ideas allow for a more customized, stable, and effective health insurance plan, than does national health care, which is why this note finds that hip offers an excellent health care model for other states to follow to decrease the number of uninsured americans. iv. hip is a model for many other states struggling to insure their citizens a. hip is a model for other states hip offers a model for other states to follow to connect more citizens in each state to health care. according to u.s. department of health & human services secretary mike leavitt, hip "'is a forward-thinking plan to reduce the numbers of uninsured indiana residents .... "'132 secretary leavitt went on to say, "'[hip] is an excellent example of what can be done now in the states to advance this important objective."' '"[i] hope other states ·will follow indiana's model of combining personal responsibility with public support to help those who are truly in need gain health cover­ age. "'133 hip is a "forward-thinking plan" because it is different from plans such as medicaid and medicare, in part, because it has strictly limited bene/library/publications/the-world-factbooklprint/us.html. 131. consumers guide, supra note 103. 132. press release, supra note 1. 133. !d. 74 indiana health law review [vol. 7:57 fits and services where recipients have the incentive to be responsible for their health status, to be mindful of costs, and to utilize health care services efficiently. 134 b. unsuccessful state plans 1. the california plan california proposed a statewide health care plan in 2007 ("california plan"). 135 this plan required all california residents "not on medicare or medical (california's medicaid program)" to acquire insurance. 136 those who could not afford the insurance would be offered subsidies. 137 howev­ er, it was debated whether the subsidies would be substantial enough to cover lower-income families. 138 opponents of the plan argued that it "wasn't fair to penalize [low-income citizens] for coverage they couldn't afford.''139 as one california senator stated, the california plan is "'a knife in the throat of the working poor."'140 the california plan also placed a mandate on employers to do one of two things: either to provide health in­ surance for their employees, or to pay an additional business tax of 10 per­ cent to the state.141 this employer mandate was applicable to businesses with more than 9 employees. 142 also, the california plan required insurers to sell their product to anyone asking for it without consideration of an in­ dividual's medical condition.143 the california plan was funded by increasing payroll tax by 6 percent, implementing a 2 percent tax on physicians and a 4 percent tax on hospitals, and adding an additional $1.50 to $2.00 per pack tax on cigarettes.144 the total cost of the plan was predicted to be $14 billion annually.145 although 134. f aqs, supra note 31, at l. 135. robert stark, what works and what doesn't: a review of health care reform in the states, washington policy center for health care, august 2008, at 9, available at www.washingtonpolicy.org!centers/healthcare/policybrief7statehealthcarereforms.pdf (dr. roger stark is a health care policy analyst with the washington policy center ("wpc"). the wpc is an independent and non-partisan. research and education organization that pub­ lishes studies, sponsors events and conferences, and educates citizens on public policy is­ sues.) washington policy center, about us, http://www.washingtonpolicy.orglaboutus /missionstatement.html. 136. id. 137. op-ed, tenninated, wall st. j., jan. 30. 2008, at al6, available at hup://online.wsj.com/article/sb120165320966126977.html?mod=opinionjoumal_main_stories. 138. id. 139. id 140. id 141. stark, supra note 135, at 6. 142. id 143. id. 144. id. 145. id. 2010] get "hip" america 75 california's increase on the cost of cigarettes .is a forward-:-thinkingiidea, requiring citizens to pay an augmented payroll tax is burdensome, especial­ ly in light of the current economic climate in which residents may not have additional funds to either pay higher taxes or purchase compulsory health insurance. 2. the wisconsin plan wisconsin proposed a health care plan ('wisconsin plan'') in 2008, but it failed to pass.146 if implemented, the plan would have required "cov­ erage for all [citizens] not enrolled in an existing government program· such as medicare or medicaid."147 the wisconsin plan's goal was to offer uni­ versal coverage while also lowering costs. the plan was funded by a new 14.5 percent payroll tax, in addition to the "15.3 percent tax [that] workers already pay to fund social security and medicare."148 in its first year after passage, wisconsin legislators estimated that the wisconsin plan w,ould cost $15.2 billion.149 this would have doubled the state budget.150 3. the massachusetts plan one state plan that has proved to be unsuccessful is the massachu­ setts' "connector plan" ("massachusetts plan").151 this plan was passed in the spring of 2006 for the purpose of dealing with increased health care costs in massachusetts. 152 the plan intended to cover the estimated 550,000 uninsured massachusetts residents.ts3 proponents of the plan were deter­ mined that "the state's uninsured population would be reduced to zero .. ",154 the massachusetts plan requires "every resident between the ages of 18 and 64 to purchase a state-defined health insurance policy" beginning july 1, 2007.155 those individuals who did not purchase a policy by de­ cember 2007 would be penalized $219 through tax filings.156 the penalty would increase in 2008 to 50 percent of the average cost of a health insur­ ance plan in the geographic region where the person lives.157 146. !d. at 7. 147. id. 148. !d. 149. !d. 150. !d. 151. idat5. 152. id 153. id 154. id 155. !d. see also kaiser commission on medicaid facts. massachusetts health care reform: two years later (2008) http://www.ldiorgluninsuredlupload/7777 .pdf. (berineafter "kaiser on massachusetts"). 156. kaiser on massachusetts. supra note 155. 157. id 76 indiana health law review [vol. 7:57 additionally, all employers with more than 11 workers were required to make a "fair and reasonable" contribution to their employees health in­ surance covemge or pay a "fair share" contribution of up to $295 per em­ ployee each year. 158 massachusetts "provides subsidies for residents with incomes less than 300 percent of the [fpl]."159 residents with an income below this percentage do not pay anything.160 additionally, the massachu­ setts plan took over ''the role of private-sector insurance agents by matching individuals with state-approved health plans." 161 "[a]pproximately 350,000 people who previously had no insumnce are covered by the" mas­ sachusetts plan. 162 a majority of the enrollees, however, are also in an en­ titlement progmm that is subsidized by the state. as a result, "[i]ndividual private plans are not selling well."163 furthermore, the massachusetts plan does not have any measures in place to deal with the state's mpidly increasing health care costs.164 addi­ tionally, the plan has caused "a dmmatic increase in demand for medical services, to the point where primary care doctors are in short supply. wait­ ing times to see a family physician are up to [1] year in parts of western massachusetts."165 already, there is an early budget overrun of 30 per­ cent.166 the massachusetts governor asked for $869 million in additional funds for 2009.167 this amount is about $400 million more than 2008 and may still fall short.168 however, that number may "reach as high as $1.1 billion."169 in the next ten years, the over-run cost of the massachusetts plan is estimated to reach $4 billion.170 resultantly, there is a "proposed tax increase of $129 million."171 additionally, to control costs, the legislature is "considering cutting payments to doctors, increasing the special tax on employers (currently $295 a year), increasing the state tobacco tax, and im­ posing additional regulations on insurers and drug companies."172 current­ ly, there is no proposal to decrease mandates on individual insurance plans. as a result, massachusetts insurance carriers are finding it difficult to offer low-cost plans.173 158. id 159. stark. supra note 135, at 6. 160. id. 161. /d. 162. ld. 163. id. 164. id 165. stark, supra note 135, at 6. 166. id. 167. id. seealsokaiseronmassachusetts,supranote 155. 168. id. 169. stark. supra note 135 at 6. 170. id. 171. id 172. id 173. /d. 2010] get "hip" america 77 initially, advocates of the massachusetts plan claimed it would lower health care costs to achieve universal coverage. it has instead "increased costs for individuals and the state, in addition to reducing revenues for doc­ tors and hospitals."174 massachusetts officials are admitting that their "'universal coverage is not likely to be universal any time soon. "'175 never­ theless, benefits are increasing for individuals because the state government is requiring all patients to purchase certain "benefits" that they will never use and would never have voluntarily chosen in a free market.176 "for ex­ ample, the massachusetts plan currently requires insurance ·plans to ... [cover] in vitro fertilization, blood lead poisoning treatment, and chiro­ practor services" even if these services are not needed by the insured .. 177 the mandated benefits of the massachusetts plan have raised health care insurance costs by at least 23 percent.178 4. the washington plan in 1993 the washington state legislature passed health care reform legislation, which was known as the washington state health plan ("wash­ ington plan") in response to washington's 600,000 uninsured residents.179 the plan would require all residents to join a managed competition plan if they were not receiving coverage through medicare.180 the underlying goal of the washington plan was to provide universal coverage. the plan in­ cluded the following elements: "(1) price controls in the form of state­ imposed caps on insurance premiums; (2) statewide community ratings and universal access; (3) new mandates on employers and individuals; (4) a guaranteed issue law, and; (5) increased emphasis on public health and pre­ vention."181 the washington plan added more mandates and restrictions on employers and individuals, gave state government more control over health care, and added a new powerful state bureaucracy.182 the washington plan ultimately created overwhelmingly negative consequences.183 after the plan was enacted, 14 health insurance carriers left the state.184 those carriers that remained were forced to raise their rates 174. paul hseih. mandatory health insurance: wrong for massachuselts, wrong for ameri­ ca, 3 "die objective standard: a journal of cul1ure and pouncs 3, (2008), available at http:llwww.theobjectivestandard.com/issues/2008-fulllmandatory-health-insurance.asp (last visited apr. 8, 2010). 175. /d. 176. ld 177. /d. 178. id 179. stark, supra note 135, at 2. 180. !d. 181. id 182. id 183. id. at3. 184. id 78 indiana health law review [vol. 7:57 up to 40 percent. 185 the number of uninsured actually rose instead of de­ creasing.186 the guaranteed issue provision in the plan also caused severe consequences.187 this law required carriers to sell their product to anyone, regardless of their medical history.188 for instance, a woman who becomes pregnant could purchase an insurance plan, use it during her pregnancy and immediately after giving birth, then withdraw from coverage when it is no longer needed.189 the community rating law mandated "that premiums charged by [carriers] be an average of all premiums ... in a given region."190 the community rating and guaranteed issue rules caused two events to hap­ pen.191 first, they encouraged people who were healthy to avoid buying health insurance. 192 second, they encouraged people to avoid buying health insurance until they got sick. 193 these rules resulted in higher health insur­ ance costs for everyone.194 therefore, by 1994, there was a citizen revolt at the voting booths.195 "the governing party lost its majority, and the gover­ nor who had signed the reform the plan was forced to approve a repeal of the program."196 the washington health insurance market is still recuperat­ ing from the detrimental consequences results of the washington plan 197 5. the maine plan in 2005, maine passed a health care reform plan known as the dirigo health plan ("maine plan"). 198 this plan provides coverage beyond mai­ necare, maine's medicaid program.199 the plan's goals were to "expand access to care, contain costs, and quality" of health care.200 initially the maine plan was ''available to uninsured individuals and to business owners with fewer than 50 employees."201 the maine plan includes a guaranteed 185. !d. 186. id 187. !d. 188. jd 189. stark, supra note 135, at 3. 190. id. 191. id 192. id. 193. id. 194. id. 195. stark, supra note 135, at 3. 196. id. 197. id. 198. !d. at 7. 199. paul saucier, mainecare and its role in maine's healthcare system, the kaiser commission on medicaid and the uninsured, january 2005, at 5, available at http://www.lcff.org/medicaidlupload/mainecare-and-its-role-in-maine-s-healthcare­ system-report.pdf. 200. !d. 201. stark, supra note 135, at 7. 2010] get "hip" america 79 issue requirement.202 funding for the maine plan is provided by individuals who enroll in the program, "a one-time $53 million state 'grant,' and federal subsidies for people earning less than 200 percent of the [fpl].'.2°3 also, insurance companies are taxed ''four percent on all health insurance policies sold in the state."204 the plan includes certificate of need restrictions, which makes it difficult. for doctors and clinics to provide medical services that are current and new. 205 unfortunately, the maine plan has not provided the health coverage that it initially promised, and has been unsuccessful at controlling health care costs. 206 presently, "only 13,000 people are covered [under the maine plan] at a cost of over $50 million per year, and the program is also no longer accepting new enrollees.'' 207 c. plans similar to hip and based on individual choice and market com­ petition in contrast, two plans that have been passed in states which are similar to hip include georgia's health care plan (''the georgia plan") and flori­ da's health care plan (''the florida plan.'')208 both of these plans use indi­ vidual choice and market competition to lower costs and are currently experiencing success.209 hip, the georgia plan, and the florida plan take a different approach to health care reform. 210 these three plans "move deci­ sion-making about health care to the individual, work with market forces, and create voluntary incentives that increase choice and expand access· to health care coverage.'m1 additionally, these plans do not promote univer­ sal coverage. "instead, they direct reform policies toward people who need the most help in getting health coverage: low-income families, the chroni­ cally ill and the uninsured.'m2 1. the florida plan the florida plan was enacted in 2008 to provide health care coverage for the 20 percent of uninsured florida residents.213 the plan is voluntary 202. id 203. /d. 204. /d. 205. id 206. /d. 207. stark, supra note 135, at 7. 208. /d. at 1 0; 209. id at 10-11. 210. /d. at 2. 211. id 212. id at 10. 213. /d 80 indiana health law review [vol. 7:57 and available to residents earning less than 300 percent of the fpl who have, like hip requires, been uninsured for more than 6 months?14 the florida plan helps lower costs by creating increased competition among private insurers, which encourages them "to offer attractively-priced plans .... "215 this contrasts plans that mandate coverage because such mandates actually add 15 to 25 percent to health care coverage costs.216 the florida plan includes: ''preventative and primary care services, such as ... office visits, outpatient and inpatient surgery, urgent care, prescription drugs, durable medical equipment and diabetic supplies.'.z17 the florida plan, however, does "not cover prolonged hospital stays or specialty care.''218 as of 2008, 9 insurers submitted proposals to participate in the program, which has proven to be successful thus far.219 2. the georgia plan the georgia plan was enacted in may 2008 as a voluntary plan which "encourages use of ... low-cost health savings accounts (hsas) to provide health care coverage.''220 under this plan, residents are allowed to deduct their hsa-related insurance premiums from their income when they calcu­ late their state income tax liability.z21 this feature results in a "[6] percent reduction in the cost of health care coverage for individuals.''222 another attractive feature of the georgia plan is that it provides a $250 tax credit per worker to small business owners with 50 or fewer employees who offer hsa coverage to their employees. 223 georgia legislators "repealed state and local taxes on hsa-based insurance premiums," which further lowers the market price ofhsa plans.224 legislators also predict that its new plan ''will reduce the cost ofhsa-based insurance plans by $146 million a year, lower taxes for employees by $64.8 million a year, and save workers $6.7 million a year.'ms georgia is expecting to expand health care coverage to approximately 500,000 uninsured residents.226 214. id. 215. !d. 216. id. 217. id 218. stark, supra note 135, at 10. 219. stark, supra note 135, at ii. 220. /d. 221. id. 222. /d. 223. id 224. id 225. stark, supra note 135, at ii (citing ron bachritan, senior fellow, impact of insur­ ing 500,000 georgians previously uninsured, center for heal til transformation, may 9, 2008, available at http://www.bealthtransformation.net/galleries/wp-consurnerism !theeconomiclmpactofhb977.pdf. 226. stark, supra note 135, at 11. 2010] get "hip" america 81 d. hip offers something to build on hip, along with the georgia and florida plans, does not require much expanded government control. after all, health care problems do not neces­ sarily improve with more control from the govemment.227 furthermore, mandates for health insurance coverage cause severe problems as well.228 mandates "restrict choice in type and amount of insurance" that an individ­ ual needs or can afford without taking into account each individual's situa­ tion.229 moreover, another problem faced by some states is price control.230 "community rating, guaranteed issue, and insurance premium caps are ef­ forts by policymakers to limit rising costs by simply banning price increas­ es.'.n1 however, these types of price controls are generally unsuccessful because "prices are set by the supply and demand" of the market.232 specifically, the massachusetts plan does nothing to help those who lose their insurance coverage when they become unemployed. likewise, the wisconsin plan has its shortcomings, evidenced by the resulting ex­ treme amount of debt that the state has incurred. hip starts out with a ca­ pacity that can be built on over time, instead of a plan that covers everyone all at once. also, hip neither increases personal income taxes to pay for the plan nor places a mandate on citizens to purchase health care regardless of whether or not they can afford it. thus, universal plans, both state and na­ tional, are not the answer. residents should have the ability to choose which plan they want. hip has been in existence only since january 2008, but it is currently a leading model for state health care plans. furthermore, [t]he implementation of the healthy indiana plan in 2007 offers something to build on. it extends insur­ ance to some low-income hoosiers, offers tax credits for businesses with qualified wellness programs and encourages smokers to quit. but with many still un­ insured, there's more left to do. in 2009, the governor must explore options to go further. 233 indiana is doing its part in decreasing the number of uninsured ameri227. ld. 228. ld. at 12. 229. !d. 230. /d. 231. /d. 232. !d. 233. kevin m. brinegar, letters to the editor, state should help with health care, journal gazette, august 27,2008, at 15a, available at 2008 wlnr 16202790. 82 indiana health law review [vol. 7:57 cans by insuring hoosiers through hip, but it too has room for improve­ ment. according to fssa secretary mitch roob, '"[t]he program is signed for people who don't have access to employer-sponsored health care. "'234 in fact, hip obtains "enough funding to cover about 130,000 needy hoosiers."235 hip is still flawed in that it does not address em­ ployees who cannot afford the health care benefits offered by their employ­ ers. additionally, approximately half of the 41,948 people enrolled in hip as of december 2008 are hoosiers without dependent children.236 this is problematic because the cap on enrollees without dependent children is 34,000, while there is not a cap for adults with dependent children.237 nonetheless, even with its imperfections, hip is making history. fssa secretary mitch roob is pleased with the results of hip in its first year.238 he stated, '"[t]o go from a standing start to 40,000 insured hoosi­ ers is pretty good, and we're still going, we're still growing. '"239 secretary roob further stated, '"hip was never designed to be the end-all and be­ ali ... it was a large and important step out onto the ice, but it was the first step.'" 240 as of december 2008, the state of indiana has received 100,657 applications since beginning the program in january 2008.241 even though hip does not insure every hoosier, or even every applicant, the program is setting an example for other states to follow.242 no other state has formed a plan quite like hip. 243 hip is a first step upon which it can be expanded like the georgia plan, which is expected to increase its coverage to 500,000 people.244 hip is a realistic model for other states struggling to insure their citizens, is superior to many other state health care plans, and is taking a vital step, along with states that have enacted plans similar to hip, towards decreasing the number of uninsured americans. v. on-site health care clinics offer additional means for insuring more americans by decreasing the costs state governments must pay in health care expenses an additional creative proposition that could decrease the amount of 234. brandi watters, fssa admits problems with hip: state confident in most of the progress being made, the herald bulletin, may 26, 2008, available at http:// www .heraldbulletin.com/archivesearcbllocal_ story _147 i 93929.html. 235. id 236. shari rudaysky, state health plan for uninsured nearing capacity for some adults, the indianapolis star, dec. 29, 2008, 2008 wlnr 24894034. 237. !d. 238. !d. 239. id. 240. !d. 241. !d. 242. watters, supra note 234. 243. id 244. stark, supra note 135, at 11. 2010] get "idp" america 83 health care costs that state governments pay out for their health care plans includes implementing health care clinics, which offer preventative health care, into government agencies and into state sponsored health care plans. these on-site health care clinics would allow for an increase in the capacity to insure more americans by decreasing health care costs. a growing number of companies are providing on-site health care clinics with services such as free check-ups, screenings, and prescription drugs.245 some com­ panies, "such as intel corp., walt disney co., and toyota motor corp., are opening ... on-site" clinics for their employees that are "staffed by physi­ cians and nurses that offer primary-care services."246 novia careclinics, llc (''novia"), based in indianapolis, indiana and carehere, llc ("care­ here"), based in central tennessee, are two companies that manage and implement these type of on-site clinics into businesses and government agencies. a. novia careclinics,llc. ("novia"), indianapolis, indiana novia manages and creates on-site health care clinics for employers. these on-site clinics provide primary health care services to employees and their dependents.247 ·novia's management services allow employers tore­ duce the costs of insurance coverage while also providing excellent insur­ ance benefits to employees.248 some of the services novia provides include: "[ c ]linic operations management, including inventory maintenance and staffing[; o]n.;line scheduling and electronic medical records systems[;] individual health risk assessments[; p ]re-disease management and educa­ tional reach-out programs[; h]ealth coaching[; a]ssistance in chronic disease management[; and] ... [e]mployee population health management and ac­ countability. "249 novia decreases health care costs for employers by providing on-the­ job care. the clinics are wellness-based, and the goal is to encourage em­ ployees to stay healthy while also decreasing health care costs. the clinics are staffed by physicians recruited from the employer's local community.250 employees and their families have access to the clinics at no additional cost.251 the idea of such health care clinics is to help decrease the amount 245. m.p. mcqueen, workers get health care at the office, wall st. j., nov. 18, 2008, available at http://online.wsj.com/article/sb122696833222435529.html. 246. /d 247. welcome to novia care clinics, http://www.noviacareclinics.com (lasted visited dec. 31, 2008). 248. id 249. id 250. leslie condre and floyd hindbaugh, novia careciinics opens offices for elkhart county government, www.noviacareclinics.com/news.cfin/id/1 (lasted visited dec. 31, 2008). 251. id 84 indiana hea.lm law review [vol. 7:57 which governments pay out in health care related expenses. states may save by implementing clinics into government agencies for employees to utilize as well as implementing them throughout the state for citizens who are insured by state health insurance plans, such as hip, to use. such clin­ ics help cut overhead medical costs. for example, the elkhart county government, the first government entity to contract for and provide novia's on-site health care services in indiana, has utilized the services by building an on-:site clinic for its em­ ployees to use.252 novia's services offer ''the 880 employees and retirees on the eklhart county medical plan[] a full range of health and wellness bene­ fit services."253 employees receiving coverage from the county's health insurance plan will receive the following benefits: "[ c ]onvenient access to primary care physician services with no co-pays or deductibles[; t]he ability to receive commonly used generic prescription drugs[; and a ]ccess to health risk assessments, educational programs, and wellness initiatives which are intended to improve long term health of participating employees.'.254 as a result of the on-site clinic, employees of elkhart county government will be healthier and, in the long run, medical expenses are expected to decrease. another on-site health care clinic implemented by novia is in fishers, indiana. faced with escalating health care costs growing about 14 percent annually, the town of fishers needed to take immediate action.255 thus, fishers is erecting a health care clinic in part of its train station for us.e by town employees. 256 officials are hoping the town will save approximately "$1 million in health-care costs over the next three years.'.257 the clinic will allow town employees to visit the clinic for regu]ar check-ups and ob­ tain prescriptions at no cost.258 not only do the employees benefit, but the town saves because the employee visits will cost much less than visits to a doctor's office.259 furthermore, fishers will be able to purchase medica­ tions at wholesale prices, which will save in prescription costs.260 fishers town manager gary huff opined about novia's health care clinics by stat­ ing, "'[i]t's a very innovative approach, and i think it's where a lot of muni­ cipalities will end up ... if you don't look at doing some of those things, the health care costs are going to eat you up."' 261 statistically, from july 2007 to july 2008, fishers paid about $3.4 mil252. id 253. /d. 254. id. 255. carrie ritchie, town plans clinic to cut costs," fishers star, december 18, 2008,http://www.indystar.com/article/20081218/local0102/812180324/1015/localol. 256. id 257. id 258. /d. 259. /d. 260. /d. 261. ritchie, supra note 255. 2010] get ''hip" america 85 lion for health care related expenses for its employees.262 the town is hop­ ing that health care expenses will decrease by about "$166,000 in 2009; $324,000 in 2010; and $461,000 in 2011."263 further, fishers anticipates paying approximately $25 per month per employee, and incurring minimal expenses for the renovations at the train station?64 according to scott fad­ ness, co-chairman of the committee that recommended the clinic, '"[t]here are very few times in government where you can provide an additional ben­ efit to your employees and also save the town and taxpayers money ... and when you find those opportunities, you need to jump on them right away.'" 265 b. carehere, llc., central tennessee carehere is another on-site clinic management company. as of2008, carehere manages more than 60 clinics nationwide.266 carehere integrates wellness and case management with on-site physicians to impact employers that are self-funded with large health care savings.267 the town of smyrna, tennessee implemented one of carehere's on-site health care clinics. smyrna employees receive health care from a physician and/or a nurse prac­ titioner at no additional cost, and certain prescriptions are available for free.268 galveston county and the city of galveston have implemented two of carehere's health care clinics.269 these on-site clinics are expected to have numerous positive effects. in fact, ''the clinics are expected to have a posi­ tive impact for local taxpayers by trimming government employee health care costs.'mo the expectation is that on-site health care clinics offer a healthier workforce, reduce medical costs to the employer over time, and allow employees to spend more time at work and less time at the doctor's office. the same savings could be acquired by the indiana and other state governments if such health care clinics are implemented in states through­ out the country as part of state health care plans as well as in state govern­ ment agencies themselves. establishing on-site health care clinics in addition to or as a part of hip could save the state of indiana millions of 262. /d. 263. /d. 264. /d. 265. /d. 266. about us, www.carehere.com/about.asp (last visited dec. 31, 2008). 267. /d. 268. town of smymo cuts ribbon for on-site medical clinic, http://www.carehere.com/ includes/downloads/20080828 _smyrna. pdf (lasted visited dec. 31, 2008). 269. galveston county employees healthcare center, guidry news. may 8, 2008, http://carehere.com/includesldownloads/05092008 _galveston. pdf. 270. /d. 86 indiana health law review [vol. 7:57 dollars in health care related costs.271 after all, the town of fishers alone is expected to save approximately a million dollars in three years. vi. conclusion in conclusion, hip offers an excellent health insurance model for the states, especially those states struggling to connect their citizens with health care. hip's model is especially needed during this time of economic down­ fall when employers are increasingly dropping health care plans for their employees. hip offers health insurance coverage to indiana hoosiers based on market competition, personal responsibility, wellness, and public support while also demanding a modest payment of premiums by the insured based on income.272 hip makes it possible to insure more hoosiers, but will not deplete the indiana treasury. hip supplements employer-sponsored health care insurance, medicaid/medicare, hoosier healthwise, and other already implemented plans to collectively help decrease the number of uninsured hoosiers. hip encourages people to maintain employer-sponsored health care policies, and then works to provide quality and affordable health care to the uninsured. furthermore, taking a statewide universal health care coverage ap­ proach is not hip's purpose because that route, like a national universal health care plan, is not currently affordable and/or sustainable. considering many employers currently offer excellent health care benefits, switching to a statewide universal health care plan may lessen the quality of health care for many individuals because universal coverage would be more expensive and possibly sacrifice quality of care for quantity of persons insured. 273 hip is a plan on which expansion is possible. it does not insure everyone all at once, but starts with a capacity to insure 130,000 people. through addi­ tional innovative practices, however, such as increasing cigarette taxes and inserting on-site health care clinics into the plan, hip will be able to insure more and more hoosiers in each year to come.274 if other states use hip as a model and narrowly tailor their health care plans to meet the individual needs of their citizens, as hip has, the number of uninsured americans na­ tionwide will likely decrease substantially. overall, hip offers regular and sufficient health care coverage with "name brand" health care insurers.275 hip, along with the buy-in option, takes into account people with different needs and different income levels. hip does not cover everyone, but is a novel and well-designed plan that has 271. see e.g, town of smyrna, supra note 254 and galveston county employees, supra note 255 (providing examples of savings in health care costs by establishing on-site clinics). 272. see supra §ii (details on hip). 273. see supra §iii (comparison of hip to national universal health care plans). 274. see supra §v (details on on-site health care clinics). 275. see supra §ii (details on hip insurance carriers). 2010] get ''hip" america 87 promising potential and is a first step in the right direction to insuring more americans. if the hip framework is more widely adopted, the goal for every american to have health insurance coverage may be more realistical­ ly achieved. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i microsoft word 1-masthead vol. viii.doc robert l. rabin robert l. rabin is the a. calder mackay professor of law at stanford university. he received his b.s., j.d., and ph.d. (political science) from northwestern university. he has served as senior environmental fellow at the environmental protection agency, 1979-1980; visiting fellow at the centre for sociolegal studies, oxford university, in 1982; fellow at the center for advanced study in the behavioral sciences, 1982-83; visiting professor at harvard law school, 1987-88; jack n. pritzker distinguished visiting professor of law at northwestern university school of law, fall semester 1994; and visiting professor at new york university school of law, 1999-2000, 2007-08, 2009-10. he has also been involved in a variety of professional activities, including serving as reporter for the aba action commission to improve the tort liability system, 1985-87; associate reporter, ali reporters' study, enterprise responsibility for personal injury, 1988-91; program director, tobacco policy research and evaluation program, robert wood johnson foundation, 1992-96; member, advisory committee, restatement of torts, products liability, 1992-97; senior program consultant, substance abuse policy research program, robert wood johnson foundation, 1996-2002; member, institute of medicine, committee on reducing tobacco use, 2004-07; member, advisory committee, restatement of the law third torts: liability for physical and emotional harm, 1997; and member, editorial board, foundation press, 1984 . professor rabin teaches courses in torts, toxic harms and protection of personality. among his published books are cases and materials on tort law and alternatives (with m. franklin & m. green), foundation press (9th edition, 2011); torts stories (with s. sugarman), foundation press (2003); regulating tobacco (with s. sugarman), oxford university press (2001); perspectives on tort law, aspen publishers (4th edition, 1995); and smok268 indiana health law review [vol. 8:2 ing policy: law, politics, and culture (with s. sugarman), oxford university press (1993). the vaccine no-fault act: an overview robert l. rabin∗ my brief overview of the vaccine act1 is meant to set the stage for the other presentations on this panel. in doing so, i will outline the vaccine nofault program, comment on its distinctive character, and discuss briefly the high profile autism/thimerosal controversy, which has tested the program’s limits. unlike workers’ compensation and auto no-fault plans, the vaccine act had its origins in a proactive industry effort in the 1980s to avoid the perception of unpredictability that had generated considerable criticism of vaccine-related tort claims. when the act was adopted in 1986, there was only one manufacturer of the polio vaccine, one of measles, mumps, and rubella (“mmr”), and two of the diphtheria, tetanus, and pertussis (“dtp”) vaccine—and these manufacturers were all at various stages of threatening to withdraw from production. in fact, according to a congressional study2 that was a lead-up to the adoption of the vaccine act, just prior to the enactment of the program the annual number of claims was fairly predictable and relatively small in every category with the exception of pertussis. it seems fair to say that open-ended tort damages played a dominant role in animating the industry concern; more so than the unpredictability of the volume of cases. so the act was passed in 1986, and the program came into effect in 1988. although the act is a no-fault scheme, it does not, in fact, eliminate recourse to tort. but it does diminish its appeal.3 initial recourse to the nofault scheme is required, and either dismissal there or rejection by the petitioner of the administrative award before a tort claim can be filed—but more about the administrative process in a moment. the tort remedies have been scaled back: no punitive damages, no liability for “unavoidable injuries,” (the magic statutory term in the preemption case just cited and discussed by other panelists) when the vaccine has been properly prepared and ∗ a. calder mackay professor of law, stanford law school. this is an edited transcript of my introductory comments on a panel, “vaccines and drugs: a brave new tort world,” at the 2011 annual meeting of the association of american law schools. my appreciation to professor catherine sharkey for inviting me to participate and for her role in organizing and moderating the panel. 1. national childhood vaccine injury act (“ncvia”) of 1986, pub. l. no. 99-660, § 2110, 100 stat. 3755, 3758-3771 (1986) (codified at § 300aa-1 to 300aa-34); see also national vaccine injury compensation program (“vicp”), about the vicp, hrsa.gov, http://www.hrsa.gov/vaccinecompensation/ (last visited mar. 29, 2011). 2. h.r. rep. no. 99-908, reprinted in 1986 u.s.c.c.a.n. at 6361. 3. undoubtedly, even more so after bruesewitz v. wyeth, inc., 131 s.ct. 1068 (2011), decided after this talk was given, holding that design defect claims are preempted by the act. 270 indiana health law review [vol. 8:2 a proper warning has been provided. the framework of the administrative compensation scheme itself, which is preliminary to the tort option, is that no-fault benefits are provided for enumerated covered vaccines—coverage that has been greatly expanded in recent years. under the statutory scheme, the covered vaccines were accompanied by a vaccine table.4 a statutory index was established linking each covered vaccine to designated side effect injuries and time frames for the occurrence of injury. so, for example, with regard to the mmr vaccine, if one suffered anaphylactic shock within four hours of the vaccination, the victim fell within the index. as a consequence, by establishing a “table claim,”—that is, an injury satisfying the table criteria―there is a statutory presumption of eligibility for compensation. in addition, there is provision for the possibility of a so-called “offtable” injury from a covered vaccine, one that isn’t listed in the scheme; these are also eligible for compensation. but in these latter off-table cases, no presumption operates: the claimant has to satisfy a preponderance of the evidence standard in order to recover. as one might surmise, causation becomes a critical issue in these latter cases. expert testimony is needed and extensive documentation of past health records is required. currently, most claims are in fact actually for off-table injuries, because a more refined scientific approach to table listings has replaced the more loosely-based, evidence-shy original table listings. indeed, some of the initially-covered table injuries have actually been eliminated so that the claims are now off-table, and vaccines that have come under the act more recently have come without the specification of associated injuries. thus, a special master with many years of experience tells me that in the early years of the program when he first started, ninety percent of the cases were covered cases, and now roughly ninety percent are off-table cases: it is that dramatic a change. procedurally, the act adopts an adversary process: department of justice attorneys represent the department of health and human services, which serves as the administrator for the vaccine injury compensation trust fund (the “fund”),5 in the vaccine court. the vaccine court consists of special masters, who hear the cases, a possibility of appeal to the u.s. court of federal claims, and from there to the circuit court of appeals for federal claims. the claimant has a number of options: if the claimant gets an award, it can either be accepted or rejected with the option to file a tort claim in federal or state court; or, if there is an adverse decision 4. see ncvia § 2114; see also national vaccine injury compensation program, vaccine injury table, hrsa.gov, http://www.hrsa.gov/vaccinecompensation/table.htm (last visited mar. 29, 2011). 5. national vaccine injury compensation program, vaccine injury compensation trust fund, hrsa.gov, http://www.hrsa.gov/vaccinecompensation/vic_trust_fund.htm (last visited mar. 29, 2011). 2011] the vaccine no-fault act: an overview 271 in the vaccine court, a tort claim can similarly be filed in state or federal court. in terms of the structure of awards, recovery is provided for medical expenses, without limit, for injury claims; wage loss for a child, based on lifetime national average wages as a ceiling; and pain and suffering with a cap of $250,000. death claims have an absolute cap on overall recovery of $250,000. there is no contingency fee for attorneys; fee awards are for reasonable hours and are determined by the special masters. interestingly, if the claim appears to have been brought in good faith, attorney’s fees are available even in cases where benefits are denied. the fund is financed by a per-dose tax on manufacturers. let me make a few brief comments on the framework before i turn to the autism controversy. first of all, from a compensation perspective, in death cases, as i just mentioned, there is a scheduled ceiling of $250,000. but that cap should not necessarily be regarded as a pale shadow of tort—at least not in those states following the traditional statutory approach of limiting tort wrongful death recovery to pecuniary loss to survivors. by contrast, however, under modern wrongful death statutes that allow survivors to recover non-pecuniary loss in the torts system, tort would compare favorably to the compensation scheme, since there is no designated ceiling on non-pecuniary loss. in injury cases, as i indicated, the fund has a ceiling on wage loss, and scheduling of pain and suffering; this is consistent with the no-fault model generally and it does avoid open-ended speculation that would particularly characterize a child or infant claim for lifetime lost wages, as well as pain and suffering, in the tort system. there is no collateral source rule under the fund; in other words, unlike the majority approach in torts, collateral sources are netted out. and the attorney fee awards—rejecting the contingency fee system—are yet another major departure from the tort system. from a process perspective, like tort, the fund is based on an adversary model; but it is an expertise model. the special masters hear only vaccines cases and the process anticipates liberal rules of admitting evidence and expert testimony—although, i am told by special masters, that as scientific evidence has come to be dominant, and as the off-table cases have come to characterize the caseload, the admission of evidence and admissibility of experts has become very similar to the tort system. in fact, the special masters purport to be following daubert6 on admissibility. from an efficiency perspective, the administrative costs of delivering benefits are considerably lower than in the tort system. while the figures i have seen vary, it appears that somewhere between ten and thirty percent in administrative costs are incurred in payouts under the system, which is far lower than tort. the processing time, however—and this comes as a sur 6. daubert v. merrell dow pharmaceuticals, 509 u.s. 579 (1993). 272 indiana health law review [vol. 8:2 prise—is quite substantial. even in undisputed cases it can be up to three years between filing and an award, and in disputed cases it can be five to seven years, or even more, before the cases run the full administrative process (including the time in which the special master determines the attorney’s fees). in sum, as the special master proceedings have come increasingly to be demanding of science-based findings on causation, the hearings have increasingly come to resemble the tort process with attendant delays in delivering compensation. but having said that, the ceilings on awards, the credits for collateral source benefits, the routinization of attorney’s fee awards, and the existence of no-fault recovery seem to lead to far greater predictability for manufacturers about payouts and to injury victims about eligibility. and, the program is considerably less expensive than torts to administer. let me close with a brief comment on the thimerosal/autism cases that test the limits of the program. in may 2010, the circuit court of appeals for the federal circuit decided hazelhurst v. secretary of health and human services,7 an appeal from the denial of a claim that an mmr vaccination caused autistic-like symptoms in a child who was just under one year old. the court affirmed a special master’s denial of compensation. the case had been consolidated with two other test cases as part of the omnibus autism proceeding,8 in which more than five thousand cases have been filed. at this point, there have been no successes; all of the cases that have been decided have been dismissed by special masters, although most of the claims have yet to be heard. two types of claims have been brought: one type is based on the thimerosal preservative and the mmr vaccine in combination; the second set of cases is based on the mmr vaccine itself causing autism. on appeal in hazelhurst, it was the latter theory that was relied on; that is, that the mmr vaccine in and of itself caused the injury. the plaintiff’s theory is that the measles component of mmr causes an immune system dysfunction leading to inflammation of the gastrointestinal tract and in turn inflammation of the brain, with the latter causing autism. that theory, which has been widely discredited, stems from scientific papers first published in lancet,9 a british journal, in 1998. subsequently, the lead author lost his license to practice medicine and there have been innumerable charges of fraud in those studies. 7. hazelhurst v. sec’y of health and human svc., 604 f.3d 1343 (fed.cir.2010). 8. see national vaccine injury compensation program, about the omnibus autism proceeding, hrsa.gov, http://www.hrsa.gov/vaccinecompensation/omnibusproceeding.htm (last visited mar. 29, 2011). 9. a.j. wakefield et al., ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. 351 lancet 637 (1998), available at http://www.thelancet.com/journals/lancet/article/piis0140-6736(97)110960/fulltext#article_upsell. 2011] the vaccine no-fault act: an overview 273 indeed, just before this panel presentation, the new york times published an article discussing new findings adding yet another voice to the consensus of discrediting research.10 nonetheless, the plaintiffs were able to find expert witnesses to provide testimonial support in the special master hearings, and in hazelhurst itself, the full administrative record ran thousands of pages of medical literature, four thousand pages of hearing testimony, and fifty expert reports. as in all the other proceedings, the special master in hazelhurst, found that the lab procedures were flawed and that there was no scientific basis for establishing causation. with a handful of inconclusive exceptions, the cases have yet to enter the tort system, so it is impossible to know how they will play out, if at all, before juries assuming tort is pursued—despite the total lack of success in the administrative system. examining the special master opinions in these cases, as i have, one cannot help but note the serious character of the assessment of the scientific data and the virtues, as i see it, of low visibility decision-making—by which i do not mean opaqueness. indeed the administrative proceedings are characterized by very lengthy opinions assessing the scientific findings; the special master process is highly transparent, far more than jury verdicts. what i do mean by low visibility is the insulation from the political pressures and personal sympathies that can lead even the food and drug administration, let alone judicial trials, to compromise the mandate to base compensation awards on scientific findings. in the end, the autism/thimerosal controversy is a case study of the vaccine no-fault system under maximum and unusual stress. and by all accounts, the resolution, at least at present, provides a positive endorsement for the expertise model in this particular set of toxic exposure cases, with the qualification that the massive proceeding has unfolded over a decade and has not yet been concluded. 10. editorial, autism fraud, n.y. times (jan. 12, 2011), http://www.nytimes.com /2011/01/13/opinion/13thu2.html. microsoft word 1-masthead vol. viii.doc malcolm wheeler malcolm wheeler is a founding partner of wheeler trigg o’donnell llp in denver, colorado. he specializes in civil litigation, especially the defense of complex and pattern product liability litigation and consumer class actions. he has tried cases to verdict in fourteen states, appeared in trial courts in more than forty states; and briefed and argued cases in the united states supreme court and other federal and state appellate courts throughout the nation. mr. wheeler has been professor of law at the university of iowa and the university of kansas. he also served as chief counsel to the united states senate select committee on undercover operations of the department of justice (the abscam investigation). he has been an advisor to the reporters for the restatement (third) of torts: general principles and an advisor to the reporters for the restatement (third) of torts: apportionment of liability. he received an s.b. degree in 1966 from m.i.t. and a j.d. degree in 1969 from the stanford law school. he is a fellow in the american college of trial lawyers; was named best lawyer in colorado super lawyers in 2011; was named a national bti client service all-star in 2011; was named one of three “star” u.s. product liability lawyers by chambers usa in 2010; was voted one of the 10 most admired product liability lawyers in the u.s. in product liability law 360 in 2010; is listed in chambers usa, best lawyers in america, the legal 500: united states, the which lawyers? yearbook, and colorado super lawyers; and received the john raleigh lifetime achievement from the product liability advisory council. the case for preemption: why the u.s. supreme court and the administration are wrong to curtail implied conflict preemption malcolm e. wheeler* transcript of proceedings1 because you in the audience today are torts scholars interested in preemption and i am no longer in academia, but have been litigating preemption issues for more than a quarter-century, i’m going to provide some remarks about the practical development, rather than the theory, of preemption law. i argued geier v. american honda2 in the supreme court for honda on pearl harbor day in 1999. the court decided it in may 2000, five to four in my favor. i’ll first describe how we got there and then comment on some of the subsequent developments in conflict preemption. the “no-airbag” lawsuits that culminated with the supreme court’s decision in geier in 2000 began in 1983. hundreds of them and related “no-passive-restraints” lawsuits were filed in succeeding years. the plaintiffs in the latter group claimed that all cars made without passive restraints—restraint systems designed to provide second-collision protection3 to vehicle occupants in crashes without the occupants’ taking any affirmative action, such as buckling their seatbelts—were defectively designed. the two categories of passive restraints at the heart of those cases were airbag systems and passive seatbelt systems (seatbelts that automatically moved into place around the occupant of a particular seat when the occupant closed the door adjacent to that seat).4 when the “no-airbag” litigation began, no manufacturer was making vehicles with airbags, and only a tiny fraction of vehicles had passive seatbelt systems. plaintiffs who had failed to buckle their seatbelts in vehicles with manual seatbelts and no airbags and had been injured in accidents gen * mr. wheeler is a founding partner of wheeler trigg o’donnell llp, denver, colorado, and formerly a professor of law at the university of iowa college of law and the university of kansas school of law. 1. revised and annotated by author for publication. 2. geier v. am. honda motor co., 529 u.s. 861 (2000). 3. a “second collision” is the collision that occurs between a vehicle occupant and some part of the vehicle interior, such as the steering wheel or the instrument panel, after the vehicle first collides with another vehicle or some other object. 4. airbag systems and passive-seatbelt systems also usually included a knee bolster, a padded protrusion below the instrument panel that was intended to limit the forward movement of the occupant’s knees, thighs, and lower torso in a frontal crash, thereby reducing the risk that the occupant would slide forward under the shoulder harness if the seatbelt system did not include a lap belt. 320 indiana health law review [vol. 8:2 erally made “no-passive-restraint” claims. plaintiffs who had buckled their manual seatbelts and had been injured in accidents made “no-airbag” claims. as i looked at the litigation in its infancy on behalf of my automotive clients, i thought: the auto companies can’t litigate these on a case-bycase basis. if they litigate these on a cases-by-case basis, every single frontal crash that occurs, and every side-impact crash that occurs, throughout the united states is going to be a “no-airbag” claim or a “nopassive-restraint” claim. there will be not just thousands, but millions, of these cases over the years because there are more than 150 million motor vehicles without airbags on the roads and more than six million police-reported motor-vehicle crashes annually.5 the defense costs for litigating the cases in courts throughout the country will exceed the manufacturing cost of some cars. the problem was that there were twenty-four reported decisions that were unrelated to “no-passive-restraint” claims but that, broadly read, could be read to say, and had been widely viewed as saying, that there could be no preemption of state-law tort claims under the national traffic and motor vehicle safety act of 19666 (the “safety act”) and its implementing regulations promulgated by the national highway traffic safety administration (the “safety administration”). but when i examined those cases closely, i concluded that none of them actually said, “there is no preemption under the safety act.” instead, each of them found no preemption because of the particular facts of the case; addressed only field preemption, not express preemption or conflict preemption; or addressed not a preemption argument at all, but an argument that the vehicle was not defectively designed because it complied with an applicable federal motor vehicle safety standard promulgated by the safety administration.7 because of the extensive regulatory history regarding passive restraints, and airbags in particular, i thought the most compelling argument in the “no-airbag” cases would be an implied preemption argument focused on the federal agency’s stated pur 5. see, e.g., united states department of transportation, traffic safety facts 1994, pp. 14-15 (aug. 1995) (showing number of reported crashes for each year in 1988 through 1994 and number of registered motor vehicles for each year in 1966 through 1994). 6. national traffic and motor vehicle safety act of 1966, pub. l. no. 89-670, 80 stat. 931 (codified as amended at 49 u.s.c. §§ 30101 et seq.). 7. see, e.g., dawson v. chrysler corp., 630 f.2d 950, 958 (3d cir. 1980), cert. denied, 450 u.s. 959 (1981). 2011] the case for implied conflict preemption 321 poses and on the conflict between those purposes and the state-law tort claims the plaintiffs were asserting. so from the very beginning we litigated these cases with a narrow approach that focused on the detailed, complex passive-restraint regulatory history that had begun in the late 1960s. we formulated arguments carefully explaining why, given that narrow focus and that unique regulatory history, a finding of preemption in these cases would not mean that a broad swath of automotive product liability claims—for example, claims of defectively designed brakes, steering systems, or fuel systems—would be preempted. we also carefully chose the cases in which to make the arguments, and we purposefully made the first case in which we chose to make the arguments a case in a federal court in missouri. we could have made it in any of several other courts, but we wanted to test the arguments in a federal court, not a state court, for a couple of reasons. first, we thought that state courts would be somewhat inclined to think, “i’m not going to dismiss this case brought by a citizen of this state in this court under this state’s tort law simply because some federal agency has promulgated a regulation addressing the issue.” second, unlike many state trial courts, federal district courts had law clerks who were likely to have time to study the regulatory history and to read the prior preemption cases as closely as they had to be read to see that they had not foreclosed preemption under the safety act and its implementing regulations. we also preferred to test the arguments in a court in the middle of the country, rather than one in, for example, california, florida, or new jersey—states that had been leading the expansion of product-liability law for nearly two decades at the time. we certainly did not want to make the argument in one of the courts that in today’s vernacular are called “judicial hellholes.” we wanted a court that we thought would be open to considering in detail why the safety administration had regulated the issue as it had, how consumers would be harmed by the premature introduction of airbags before the technology had advanced to a point at which it would not cause severe injuries and fatalities to occupants who otherwise would have escaped such severe injuries, and why the law had to be applied by keeping in mind the safety of the people who were being protected by the safety administration’s regulatory stance, not just the individuals who were in court claiming to have been injured because manufacturers had acted in compliance with their understanding of that regulatory stance. when we won that case,8 we made the motion in another federal court and won again.9 soon after that we made the arguments in a state court in 8. vanover v. ford motor co., 632 f. supp. 1095 (e.d. mo. 1986). 9. cox v. baltimore county, 646 f. supp. 761 (d. md. 1986). 322 indiana health law review [vol. 8:2 alaska, and we won again.10 but almost all the auto companies began facing “no-airbag” and “no-passive-restraint” claims, and trial courts throughout the country were deciding preemption motions. when some courts held the claims preempted and other courts held them not preempted, we had to decide which case or cases we wanted to be the first to be decided on appeal, because ultimately our aim was to get to the united states supreme court, but with a case having good facts and positioned at the best time within the lengthy regulatory history to show the conflict between the safety administration’s regulation and the state-law tort actions. accordingly, we asked ourselves a variety of questions: would our arguments be better received in a federal court of appeals or in a state appellate court? which courts, panels, and judges had a history of being at least somewhat hospitable, and which hostile, to preemption arguments? which of our cases, or which cases being defended by other firms, had plaintiffs who would generate little judicial sympathy—for example, a plaintiff who had chosen not to buckle the available seatbelt and, in addition, had engaged in reckless conduct by driving at an excessive speed or while drunk and, still further, had not incurred a catastrophic injury? which of our cases, or which cases being defended by other firms, arose out of crashes in which the vehicle in issue was manufactured at a time in the lengthy regulatory history when the safety administration’s rulemaking purposes most clearly were inconsistent with a “no-airbag” tort claim? once again, we thought that, all other factors being equal, a federal court of appeals would be somewhat more likely to find preemption than would a state appellate court. for a variety of reasons, the first case that went up on appeal was wood v. general motors,11 in the united states court of appeals for the first circuit. when that court found preemption and the plaintiff filed a petition for a writ of certiorari in the supreme court, however, the time did not yet seem right, so general motors opposed the petition. the supreme court denied the petition. over the next few years, the third circuit,12 ninth circuit,13 tenth circuit,14 and eleventh circuit,15 as well as several state appellate courts,16 held “no-airbag” claims or “no-passive-restraint” claims preempted, and a 10. soboscienski v. ford motor co., no. 2no-85-246 (alaska super. ct. oct. 18, 1986). 11. wood v. general motors corp., 865 f.2d 395 (1st cir. 1988), cert. denied, 494 u.s. 1065 (1990). 12. pokorny v. ford motor co., 902 f.2d 1116 (3d cir.), cert. denied, 498 u.s. 853 (1990). 13. harris v. ford motor co., 110 f.3d 1410 (9th cir. 1997). 14. kitts v. gen. motors corp., 875 f.2d 787 (10th cir. 1989), cert. denied, 494 u.s. 1065 (1990). 15. taylor v. gen. motors corp., 875 f.2d 816 (11th cir. 1989), cert. denied, 494 u.s. 1065 (1989). 16. e.g., boyle v. chrysler corp., 177 wis. 2d 207, 501 n.w.2d 865 (ct. app. 1993). 2011] the case for implied conflict preemption 323 few state appellate courts held claims of the same nature not preempted.17 by 1995 more than 120 courts, including more than a dozen appellate courts, had ruled on the issue. the case that ultimately reached the supreme court was geier, a “no-airbag” case involving a driver who had been wearing the available lap-shoulder seatbelt when she crashed her 1987 honda. the united states court of appeals for the district of columbia circuit held the “no-airbag” claim preempted; the plaintiff filed a petition for a writ of certiorari; and the supreme court granted the petition and affirmed. i provide all that as background to show that how the supreme court shapes preemption law can depend significantly on how litigants shape the law for presentation to the supreme court for decision. i also provide it because i think that, had the same approach been followed to the end with respect to preemption in the pharmaceutical arena, the supreme court never would have decided wyeth v. levine18 in 2009 and the state of preemption law in the pharmaceutical arena would look quite different than it does today. in fact, i tried to follow a similar approach in the pharmaceutical arena. i thought i had an excellent medication, an excellent regulatory history, and an excellent case factually in which to establish that, in a narrow category of cases, state-law claims that the labeling for a particular prescription medication provided inadequate warnings of a particular adverse side-effect can be preempted because of a conflict with the federal food, drug, and cosmetic act19 (“fdca”). the medication was zoloft®, a member of the class of antidepressants called serotonin selective reuptake inhibitors, or ssris. the ssri litigation started with another ssri, prozac®. after the fda approved prozac® in 1987 for the treatment of patients with major depressive disorder, it quickly became the leading medication prescribed for patients with depression, one of the most common and debilitating illnesses in the world and an illness that all too frequently resulted in suicide and other self-injury.20 over time, the food and drug administration (“fda”) also approved prozac® as safe and effective for the treatment of several other psychiatric disorders. an important advantage of prozac® was that, unlike previously available antidepressants, it could not readily be used to commit suicide by ingesting an overdose. nevertheless, and although the american psychiatric association’s diagnostic and statistical manual of mental disorders named 17. e.g., gingold v. audi-nsu-auto union a.g., 389 pa. super. 328, 567 a.2d 312 (1989). 18. wyeth v. levine, 129 s. ct. 1187 (2009). 19. 21 u.s.c. §§ 301-399 (2009). 20. american psychiatric association, diagnostic and statistical manual of mental disorders 350-51 (4th ed. text rev. 2000). 324 indiana health law review [vol. 8:2 recurrent thoughts of death or a suicide attempt as one of the primary criteria for a diagnosis of major depressive disorder,21 the manufacturer of prozac® began to face multiple lawsuits by plaintiffs claiming that they or a family member had become suicidal because of treatment with prozac®. the plaintiffs claimed that the fda-mandated suicidality language in the “precautions” section of prozac® labeling should have been made stronger and should have been moved to the “warnings” section of the labeling. over a period of six years, each of two entities and an individual also filed separate citizen petitions22 with the fda asking the agency to withdraw its approval for prozac® or to require that the labeling be changed to strengthen the language addressing suicidality. the fda rejected the petitions because of the absence of scientific evidence of an association between the antidepressants and suicide. the fda also conducted a public meeting in 1991 with its psychopharmacological drugs advisory committee, a group of expert physicians and scientist from academia and elsewhere,23 to consider whether the language regarding suicidality in the labeling for prozac® and other antidepressants should be strengthened. the committee and the fda concluded that it should not. in that meeting, referring to controlled clinical studies, dr. paul leber, director of fda’s division of neuropharmacological drug products, stated: “[e]valuation by fda scientists, outside consultants, and by our physicians, have not led us to conclude that there is a differential rate of risk for prozac related to suicidal thoughts, acts, or other violent behaviors.”24 he cautioned that, [t]he net effect [of additional suicidality warnings] might be a reduction in the use of antidepressants in the treatment of depression, and that result might cause overall injury to the public health. . . . we all have to remember that the best-intentioned of actions do not necessarily turn out well; they can cause harm.25 dr. thomas laughren, who headed the psychopharmacology unit of the fda’s division of neuropharmacological drug products, added that the labeling fda had approved for “suicidal ideation” and “violent behav 21. id. at 356. 22. see 21 c.f.r. § 10.30 (2010) (authorizing citizens’ petitions). 23. see 21 u.s.c. § 355(n) (2009) (authorizing the fda to form and seek advice from advisory committees of experts). 24. transcript of proceedings, fda psychopharmacological drugs advisory committee, sept. 20, 1991, p. 126, available at http://commons.wikimedia.org/w/index.php?title= file%3a1991_fda_psychopharmacological_drugs_advisory_committee.pdf&page=126. 25. id. at 129-30. 2011] the case for implied conflict preemption 325 iors” “reflects our lack of confidence in a causal link between the taking of the drug and those behaviors.”26 several other manufacturers developed similar ssri antidepressants and, after extensive clinical trials and fda review, received fda approval to market them. my client, pfizer, developed the ssri called zoloft®. after receiving fda approval, pfizer began making zoloft® available for doctors to prescribe beginning in 1992. litigation like that against prozac® followed, and i was asked to defend it. i found that the fda-mandated labeling for zoloft®, like the fdamandated labeling for prozac® and other antidepressants, contained precautionary information about suicidality. specifically, the “precautions” section stated: suicide the possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. close supervision of high risk patients should accompany initial drug therapy. prescriptions for zoloft should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose. (emphasis in original.).27 the fda-mandated labeling also informed physicians of the quantified range of rates at which zoloft® patients in clinical trials had experienced attempted suicide and suicidal ideation. and fdamandated language in the labeling stated: “it is important to emphasize that although the events reported occurred during treatment with zoloft, they were not necessarily caused by it.”28 when i looked at the zoloft® regulatory history, its documented developmental history, and the extensive medico-scientific literature analyzing its performance, i concluded that the tort claims should be preempted and that many individuals suffering from depression could otherwise be seriously harmed by the litigation and its attendant publicity. in particular, patients suffering from a disorder that often led to suicide might be induced not to seek treatment at all or might decline to be treated with antidepressants or might be noncompliant with their doctors’ dosage instructions, and some doctors might decline to prescribe the antidepressants because of a fear of malpractice actions. moreover, i considered it vitally important that it was concerns of this nature that had led the fda repeatedly to reject any warning language stating that an association between the antidepressants and suicide had appeared in the scientific evidence. 26. id. at 137. 27. physician’s desk reference 2001 (48th ed., 1994). 28. id. at 2002. 326 indiana health law review [vol. 8:2 my legal research indicated that, just as there had never been a case in which a court had held a state-law product-liability claim preempted under the safety act when we began asserting conflict preemption in the “noairbag litigation,” there had never been a case in which a court had held that the fdac preempted a state-law product-liability claim for inadequate warnings. but in this instance, unlike the typical pharmaceutical inadequate warning case, the fda had examined ssri suicidality data for about five years before approving zoloft® for the treatment of depression, had considered and rejected three citizen petitions addressing prozac® and other antidepressants, had repeatedly examined suicidality data for prozac®, zoloft®, and other ssris throughout the 1990s, was aware of the massive medico-scientific literature examining ssris, and repeatedly had found no reasonable evidence of an association between ssris and suicidality. by the time the zoloft® litigation began, the fda had examined and reexamined multiple times the growing and massive data for treatment of patients with ssris generally and for zoloft® in particular. between 1987 and 2006, not a year went by in which the fda did not look at ssri data for evidence of an association with suicidality, because there were new ssris coming out, manufacturers were seeking approval for using ssris to treat additional illnesses, and the fda was monitoring the data closely. in short, zoloft®, along with prozac®, appeared to be the most thoroughly regulated drug in the history of the world, and the possibility of an association between these medications and suicidality appeared to be one of the most thoroughly considered questions in the history of the fda. yet the tort cases continued, and i thought wrongly so. so we filed a motion in a case in the united states district court for the central district of california seeking summary judgment on alternative grounds of lack of causation and conflict preemption. when the district court granted the motion on the state-law ground and rejected the preemption argument,29 the plaintiff appealed and we cross-appealed. the department of justice (“doj”) filed an amicus curiae brief on behalf of the united states supporting conflict preemption, but the ninth circuit affirmed the summary judgment on statelaw grounds and never reached the preemption issue.30 we then made the preemption argument in a summary judgment motion in a federal district court in texas and won it.31 we then filed a similar motion in a different federal district court in texas and again won.32 after more litigation against ssri manufacturers in various trial courts, i lost a zoloft® preemption motion in a case called mcnellis33 in the united states district court for the district of new jersey. we took an in 29. motus v. pfizer, inc., 196 f. supp. 2d 984 (c.d. cal. 2001). 30. motus v. pfizer, inc., 358 f.3d 659 (9th cir. 2004). 31. dusek v. pfizer, inc., 2004 wl 2191804 (s.d. tex. 2004). 32. needleman v. pfizer, inc., 2004 wl 1773697 (n.d. tex. 2004). 33. mcnellis v. pfizer inc., 2005 wl 3752269 (d.n.j. 2005). 2011] the case for implied conflict preemption 327 terlocutory appeal to the third circuit.34 meanwhile, parallel to that was a case called colacicco,35 in which glaxosmithkline (“gsk”), the manufacturer of another ssri, paxil®, had won a preemption motion in the united states district court for the eastern district of pennsylvania. now, the backdrop to all this is that there was another pharmaceutical case coming up through the judicial system that was completely unrelated, had nothing to do with ssris, had nothing to do with antidepressants, and had nothing to do with a claimed association of the drug and suicidality. it had to do with a medication used to treat migraine headaches. that case became wyeth v. levine.36 when we filed our summary judgment motion in mcnellis, we were a full year ahead of wyeth v. levine, and we thought we were going to end up in the supreme court. unfortunately, the judge in our case took months to decide the summary judgment motion. when he denied it, we filed a motion for reconsideration, and he again took months to decide it. the time between our filing of the initial motion and the denial of the motion for reconsideration was sixteen months. meanwhile, the district court in colacicco granted gsk’s motion for summary judgment on preemption grounds and the plaintiff in that case appealed to the third circuit. even though mcnellis had fallen behind in the briefing schedule, we asked the third circuit to consolidate mcnellis and colacicco for oral argument, and the court agreed to do so. so we argued those cases together. we won both cases. the plaintiffs then filed a petition for writ of certiorari, but by this time wyeth v. levine had reached the supreme court. it had not been argued yet, but it had been fully briefed. my view was that it was nowhere nearly as good a case for conflict preemption as were the ssri cases, either factually or with respect to the regulatory histories. in wyeth a nurse had injected the plaintiff with a medication to alleviate a migraine headache, and what was the trade-off? the plaintiff lost her arm to amputation. in contrast, mcnellis was a case in which we could say to the united states supreme court, if we were to get there, this drug treats depression, and major depressive disorder is an illness that is associated with suicide. so unlike in wyeth v. levine, the trade-off here is life versus life. the fda made a determination in 1991, in a public hearing, that the public could be harmed by adding a warning saying that this drug causes suicide. the fda made that as a scientific, medical finding. the finding was not made by a lawyer, by 34. mcnellis v. pfizer inc., 2008 wl 927848 (3d cir. 2008). 35. colacicco v. apotex, inc., 521 f. 3d 253 (3d cir. 2008), vacated in consideration of wyeth v. levine, 129 s. ct. 1187 (2009), colacicco v. apotex, 129 s. ct. 1578 (2009). 36. wyeth, 129 s. ct. 1187. 328 indiana health law review [vol. 8:2 the chief counsel of fda, or by doj, but by doctors and scientists making a medico-scientific judgment about safety. but wyeth had decided to pursue the preemption issue in wyeth v. levine, and that was simply the way it was. so the supreme court decided that case before getting to mcnellis and colacicco. the court found no preemption in wyeth v. levine, and our opportunity for a ruling on narrowly focused grounds with an extensive regulatory history similar to the regulatory history in geier in vital respects was gone. so there you have two contrasting examples—geier and wyeth—of how preemption law gets shaped by the supreme court. and here, in my view, is the tragedy. following massive publicity orchestrated by lawyers representing plaintiffs in ssri cases, the fda in 2005 directed antidepressant manufacturers to change their labeling to add a black-box suicidality warning. i predicted that someday, perhaps two or three years after that, the data would show that the suicide rate increased following the implementation of the warning. and in 2007 came the first of what have now been several published studies finding an increase in the suicide rate and a decrease in the rate of ssri prescriptions.37 a finding of “no preemption” can have terrible adverse safety consequences for the public. what i also am seeing is that some lower courts are misreading wyeth v. levine as having dramatically changed the law in an anti-preemption direction. i argued a case in january of last year in the tenth circuit,38 and the then-chief judge of the tenth circuit, judge henry, said to me something like this: “you know, there was a sea change caused by wyeth v. levine.” i said, “your honor, there was not a sea change.” and he said, “counsel, if you take that position, we’re going to have some trouble.” i stood firm. the district court had found preemption, and the court of appeals remanded the case to the district court for reconsideration in light of the supreme court’s decision in wyeth v. levine. we have not yet received a decision on remand. the mistake that i think judge henry made, and that other courts interpreting wyeth v. levine have made, is in thinking that justice stevens, speaking for the majority, established a “sea change” in the test for conflict preemption by saying that when a drug manufacturer asserts preemption on the ground that the fda would have rejected a supplemental new drug application seeking approval of the warning advocated by the plaintiff, there must be “clear evidence” that the fda would have done so. the require 37. r.d. gibbons et al., early evidence on the effects of regulators’ suicidality warnings on ssri prescriptions and suicide in children and adolescents, 164 am. j. psychiatry 1356 (2007). 38. dobbs v. wyeth pharmaceuticals, no. 08-6018 (10th cir.). 2011] the case for implied conflict preemption 329 ment of “clear evidence” is not a “sea change” or new at all. justice breyer used the very same term, “clear evidence,” in geier. perhaps more importantly, i ask you this: what does “clear evidence” mean as used by justice stevens? we have, as you know, in the law of evidence, the “preponderance of the evidence” test; we have the “clear and convincing evidence” test; and we have “beyond a reasonable doubt.” what is this “clear evidence” requirement? is it an evidentiary test? if so, is it somewhere between preponderance and clear and convincing? if it is, where between them is it? where in the law of evidence has such a test ever been defined and applied? and if “clear evidence” is not an evidentiary test, is it just a directive that judges should be hostile to preemption in some undefined way? i say that wyeth v. levine did not change the law. what changed was the tone, the essentially ad hominem, attack that justice stevens made on the then-chief counsel of fda and on doj personnel who supported his interpretation of preemption law. if you take out the ad hominem attack, what you have left is the undefined “clear evidence” requirement, and i again ask, what does that mean? i say it is simply a different formulation of the presumption against preemption. so i next ask you, what is the nature of the presumption against preemption? is it a “bursting bubble”39 presumption? or is it a “weight of the evidence” presumption? if it is a “bursting bubble” presumption, it does not mean anything other than that the defendant asserting preemption must come forward with some evidence that there is, in fact, a conflict. and if “clear evidence” simply means that the defendant must come forward with a preponderance of evidence, it doesn’t mean much either. “clear evidence” simply means that the person asserting preemption ought to prove what the federal statute means, or what the federal regulation means, or what the congressional or regulatory intent was, and that the plaintiff’s state-law claim creates a conflict. but what has happened is that a number of federal judges and state judges are looking at wyeth v. levine and saying, “oh, clear evidence— wow, this is a huge burden to establish preemption,” and making it essentially impossible to find preemption. but not a single court has articulated what “clear evidence” means or how it imposes some huge new burden in some defined way. i think the reason no court has done so is that all “clear evidence” can sensibly mean is that the defendant asserting preemption has the burden of going forward with evidence showing the conflict the defendant claims to exist. now, the last thing i want to mention is that there is another preemption case currently before the supreme court that my fellow panelists have 39. fed. r. evid. 301, available at http://www.law.cornell.edu/rules/fre/acrule 301.htm. 330 indiana health law review [vol. 8:2 not mentioned: mensing.40 it is important because the issue in the case is whether generic-drug manufacturers have an obligation to change the labeling on the generic drug when they do not hold the new drug application (“nda”) approved by the fda for the branded drug. when the pioneer manufacturer continues to hold the nda, fda regulations prohibit the generic-drug manufacturers from using any label that is not identical to the label for the branded drug. so the question before the court is: even though they can’t change the label for the generic drug unless and until the label for the branded drug is changed, do generic-drug manufacturers nevertheless have an obligation to take steps to get the label changed?41 now, what is really fascinating is the government’s brief in support of the petition for a writ of certiorari, because what the government does in that brief, among other things, is argue for a subjective test for preemption. the government says that the test should be whether the generic manufacturer has new information that causes it to believe that the label should be changed; if the plaintiff doesn’t allege such a subjective belief, the claim is preempted. there has never been anything like that as a test for preemption, so it is a very interesting proposition. i’m looking forward to seeing how the government develops that argument in its amicus curiae brief on the merits, now that the court has granted the cert petition. to me, an important aspect of the current preemption situation overall is that justice stevens has retired. after i won geier, justice stevens led a campaign to overrule it. if you look at bates,42 if you look at altria,43 and if you look at the language he used in those and other post-geier cases, i think you will find that they provide “clear evidence” of an attempt to cabin geier. but geier lives, and preemption lives, just as the founders intended when they wrote the supremacy clause of the constitution. 40. pliva v. mensing, 130 s. ct. 3349 (2010). 41. actavis elizabeth, l.l.c. v. mensing, 131 s. ct. 817 (2010); actavis, inc. v. demahy, 131 s. ct. 817 (2010). 42. bates v. dow agrosciences, llc, 544 u.s. 431 (2005). 43. altria group, inc. v. good, 129 s. ct. 538 (2008). william m. sage professor sage joined the columbia faculty in 1995. he teaches health law, regulatory theory, antitrust, and professional responsibility. in the fall of 2006, be will become vice provost for health affairs and' professor of law at the university of texas at austin. he served as an intern at mercy hospital and medical center in san diego and as a resident in anesthesiology and critical care medicine at the johns hopkins hospital .. in addition, be practiced corporate law at o'melveny & myers in los angeles, and served on president clinton's task force on health care reform. from 2002 to 2005, be was the principal investigator for the pew charitable trusts' project on medical liability in pennsylvania. his awards and honors include election as fellow of the hastings center, receiving a robert wood johnson foundation investigator award in health policy research, serving on the editorial board of health affairs, serving on the institute ofmedicine' s committee on rapid advances in health care, and serving on the jcaho tort resolution and injury prevention roundtable. he has published widely in the area ofbealth care law and is co-editor of medical malpractice and the u.s. health care system (cambridge university press, 2006) and uncertain times: kenneth a"ow and the changing economics of health care (duke university press, 2003). professor sage received his ab. from harvard and his m.d. and j.d. degrees from stanford, where he was a note editor for the stanford law review. payforperformance: willitwork in theory? william m. sage· and can you imagine fifty people a day? i said fifty people a day ... walkin' in, singin' a bar of "alice's restaurant" and walkin' out? friends, they may think it's a move­ ment, and that's what it is: the alice's restaurant anti-massacree movement! ... and all you gotta do to join is to sing it the next time it comes around on the guitar. arlo guthrie, alice's restaurant the title of my lecture about pay for performance in health care (often abbreviated as "p4p") echoes a french management saying: "it's all very well in practice, but it will never work in theory." there is no doubt that medical pay for performance is popular. p4p initiatives are everywhere; a search of online news reveals nearly 2,500 stories about pay for performance in the last two years alone. folk legend arlo guthrie would have called p4p a movement-a "pay for performance medical quality movement." but before you join in, you might want to know what you are joining. so let's talk about the theory of paying for performance, to help you recognize the dangers as well as the opportunities in this particular movement as it gathers steam. i. movements without theories agreement as to the theory of any particular policy prescription is not a prerequisite for politicians endorsing it. to the contrary, american democracy seldom, if ever, generates broad consensus on the purpose of an action to be taken that results in that action. as they say, politics makes strange bedfellows. unexpected political coalitions form all the time. back in the 1970s, there was an unusual alliance between clean air environmentalists and dirty coal producers in eastern states to make sure that coal-burning power plants had to install expensive scrubbers to reduce sulfur dioxide emissions. 1 it was in the interest of the coal producers to have power plants continue to use high­ sulfur eastern coal rather than unscrubbed, cleaner coal mined in the west. 2 * professor of law, columbia university. as of september 2006, vice provost for health affairs and professor of law, university of texas at austin. a.b. 1982, harvard university; m.d. and j.d. 1988, stanford university. 1. bruce a ackerman & wiiliamt. hassler, cleancoaiidirty air 65-78 (1981 ). 2. /d. 306 indiana healm law review [vol. 3:303 around the same time, and closer to health care, a coalition formed between social liberals and fiscal conservatives to deinstitutionalize the mentally ill. 3 in the 1980s, a coalition formed between safety advocates and automobile manufacturers to induce states to enact mandatory seatbelt use laws, which the latter had resisted for decades.4 the auto makers became enamored with mandatory seatbelt laws as soon as the federal government had threatened them with mandatory airbag requirements if sufficient states did not adopt seatbelt laws. s on the other hand, fundamental disagreement on the purpose of a policy change can be crippling and destructive. in 1988, medicare's newly enacted catastrophic coverage. act was repealed before it was ever implemented because the people it affected had not understood what they would be paying for. 6 in a nutshell, those inside the beltway were solving an actuarial problem with acute care medicare using means-tested financing that made sense on fiscal grounds and on fairness grounds, while those outside did not realize that seniors would shoulder unaccustomed fmancial responsibility for an expansion in program benefits that was not meaningful to them. the fiasco that followed significantly reduced the risk tolerance of both congress and washington-based interest groups, which helped kill the clinton administration's universal coverage proposal in 1993-94.7 later in the 1990s, debate . in washington over ''patient protection" legislation-that is, regulation of managed care-foundered on the question of whether people should have a right to sue hmos. 8 it made sense for the federal government to play a larger role in managed care regulation because of erisa preemption. however, there was a fundamental disagreement between those who supported extending liability in order to make managed care function more effectively, and those (such as physicians) who hoped that 3. see, e.g., new directions for mental health services, deinstitutionauzation: promise and problems (h. richard lamb & linda e. weinberger eds., 2001); e. fuu.er torrey, our of the shadows: confronting america's mental iunesscrisis (1996); raelj. isaac& vjrginiac.armat,madnessinthe streets: how psychiatry and the law abandoned the mentally ill (1990). 4. jerry louis mashaw, the story ofmotor vehicle manufacturers association of the u.s. v. state farm mutual automobile insurance co.: law, science and politics in the administrative state, in al>mlnistrative law stories 396-97 (peter strauss ed., 2006). 5. ld. at 352. 6. pub. l. no. 1()()..360, 102 stat. 683 (1988), terminated by medicare catastrophic repeal act of 1989, pub. l. no. 101-234, 103 stat. 1979. see richard himelfarb, catastropidcpolitics:theriseandfallofthemedicarecatastropidccoverageact of 1988 (1995); theodore r. marmor & gary j. mckissick, medicare's future: fact, fiction, and folly, 26 am. j.l. & med. 225, 232-34 (2000). 7. see haynes johnson &davids. broder, the system (1997) (offering a political history of the clinton health care plan). 8. see david a. hyman, regulating managed care: what's wrong with the patients' bill of rights?, 73 s. cal. l. rev. 221,230-33 (2000). 2006] p4p: wru... it work in theory? 307 greater liability would make managed care disappear entirely.11 the resulting gridlock left the federal-:-state balance in managed care oversight to the courts, which failed to answer many of the most pressing questions regarding cost­ containment and accountability.10 at present, the biggest health care issue in washington, dc, is the newly enacted medicare modernization act ("mma "),including the medicare part d drug benefit. 11 this legislation, which represents the largest expansion of medicare spending since the program began in 1965, was supported by a bipartisan coalition with different views of what the statute was designed to accomplish. democrats voted for the bill hoping and believing that its dominant effect would be to expand access to prescription drugs for seniors. republicans voted for the bill with the long-term goals of privatizing the entire medicare program through contracts with commercial insurers and increasing individual responsibility using health savings accounts.12 my guess is that the next few years will demonstrate how difficult it is to make the mma a success given this fundamental disagreement about its purpose. pay for performance is at a similar crossroads today. rewarding physicians for health rather than illness has a long history of academic speculation going back at least to a footnote in the 1963 american economic review, in which economist kenneth arrow attributed the practice to the chinese. 13 these have been sporadic, tentative proposals from health care outsiders-in essence, theories without movements.14 in the last five years or so, by contrast, quality improvement advocates of various stripes within the medical mainstream have coalesced around p4p, a phrase that simultaneously channels the futurism of internet commerce (b2b, y2k) and the glamour of fortune 500 executive compensation.15 9. see amy goldstein & helen dewar, senate kills "patients' rights" bill, wash. post., oct. 10, 1998, at al. 10. see pegram v. herdrich, 530 u.s. 211 (2000); aetna health inc. v. davila, 542 u.s. 200 (2004); williamm. sage, ur here: the supreme court's guide for managed care, 19(5) healthaff. 219,219 (2000). 11. pub. l. no. 108-173, 117 stat 2065 (2003). 12. theodore r. marmor &jacobs. hacker,medicarereformandsocialinsurance: the c/ashesof2003andtheirpotentia/fallout,5yalej.healthpol'yl.&btidcs475,478-80 (2005); see also robin toner, rival y'uions led to rocky start for drug benefit, n.y. times, feb. 6, 2006, at al. 13. kenneth j. arrow, uncertainty and the welfare economics of medical care, 53 am. econ. rev. 941, 961 n.35 (1963). 14. see, e.g., davida. hyman & cbarles silver, just what the patient ordered: the case for result-based compensation, 29 j.l. med. & etidcs 170 (2001); david a. hyman & charles silver, you get what you pay for: result-based compensation for health care, 58 wash.&leel.rev.1427 (2001). 15. see, e.g., meredith b. rosenthal et al., payingfor quality: providers 'incentives for quality improvement, 23(2) health aff. 127, 127 (2004); sheila leatherman et al., the business case for quality: case studies and an analysis, 22(2) healthaff. 17, 17 (2003). 308 indiana heal1h law review [vol. 3:303 but the "pay for performance medical quality movement, lacks a common principle or purpose beyond frustration with conventional reimburse­ ment mechanisms and a general commitment to quality improvement. moreover, many rationales that one can articulate for p4p--and that seem to be percolating in the public and among policy makers-are either internally inconsistent or incompatible with one another. there are three fundamental questions that need to be asked about pay for performance in health care. first, will pay for performance incentives make buyers of medical care smarter? second, will pay for performance incentives make sellers of medical care more skillful? third, is pay for performance primarily a private health care innovation or primarily a governmental one? with the goal of resolving these uncertainties, let us turn to a description of the multiple, potentially conflicting explanations that have been explicitly articulated for p4p or are implicit in endorsement by particular groups. then let me suggest to you three plausible unifying theories of pay for performance, and how p4p systems might be designed to further each. i will conclude by making the case for strong government leadership in pay for performance, a need i believe to be compelling notwithstanding its secondary place in the history of the movement. ii. p4p's fellow travelers to begin to understand the tensions fu pay for performance, it is useful to compare physicians' incentive compensation to seemingly similar payment methods for lawyers, who comprise america's other "sovereign profession., litigators' contingent fees-a pre-agreed percentage of their clients' financial recovery, paid only if the lawyer prevails in court c;>r by settlement-are without doubt pay for performance. why do we pay these lawyers only for success, and not for the tasks they perform or the time they spend? two reasons are immediately relevant to a discussion of pay for performance in medicine. the first reason is to inspire lawyers to work harder for clients in pursuit of victory. the second reason is promote cost-effective work, rather than just "running up the meter." we will return to a third reason-encouraging lawyers only to take winnable cases--and a fourth-ensuring the availability of lawyers to poor clients-in a discussion of the government's role in medical p4p. one would think that medicine and law would have similar views as to how success fees relate to their underlying professional missions. not true. the notion that lawyers will work harder and more cost-effectively for clients if they are paid for getting results sends a pretty clear message that success in law is uncertain and depends on effort, which can be increased through incentive compensation. physicians, however, seem to have a very different view of the relationship between professional uncertainty and conditional payment. opinion 6.01 of the american medical association's code of medical ethics opposes the notion of paying doctors for results on a relatively 2006] p4p: will it work in theory? 309 strange ground: that patients who pay only if they get better will be misled into believing that they will get better. 16 this is exactly opposite the reason for paying lawyers for success: that litigation is risky and harder-working lawyers have a better chance of winning. in fact, critics of contingent fees in law complain that lawyers often demand risk-based fees for cases that routinely generate quick, effortless settlements. that the medical profession ascribes failure primarily to chance, not lack of effort, and that it regards failure as the rule and success the exception, constitute a fairly stunning indictment of medical quality. it is also a challenging starting point for pay for performance. policymakers, providers, payers, and the public conceive of p4p as serving a variety of worthy objectives (table 1 ), each of which is identified with a movement and a vocabulary of its own. many of the buzzwords in modern health policy are superficially compatible with p4p, which explains why we already have fifty people in the room, jumping up and down and singing a bar of the "pay for performance medical quality movement" song. p4p is an umbrella movement, like the world council of churches or the afl-cio; it attracts widespread support but may not be able to fulfill the individual aspirations of its boosters. a. patient safety the institute of medicine got into the p4p business incrementally. in 1999-2000, the 10m published to err is human, a report estimating that nearly 100,000 deaths occur from medical errors in the united states every year. 17 a year later, the 10m issued its crossing the quality chasm report, 16. am. med. ass'n, council on ethical and judicial affairs, code of medical ethics op. 6.01 (2002-03 ed.). 17. inst. of med., to err is human: building a safer health system (linda l. kohn et al. eds., 1999). 310 indiana health law revlew [vol. 3:303 in which it described six general quality goals for american health care and proposed ways to achieve them, including incentive compensation.18 in 2005, the iom released a detailed report on pay for performance, which one might consider the capstone of its efforts to connect p4p to patient safety. 19 medical errors present an obvious paradox for traditional fee-for-service reimbursement. health care services do not come with warranties. consequently, providers who deliver suboptimal care may end up earning more for subsequent consultations, hospitalizations, and procedures than those whose skill yields a quick, definitive diagnosis and cure. patient safety advocates have made much of this contradiction in their support for p4p. beyond rhetoric, some private health insurers and, more recently, medicare, have indicated that they will not pay the same providers for care involving serious mistakes.20 but can pay for performance reduce medical errors? the iom's approach regards safety as a subset of quality. it ignores the fact that safety events are rarer, more salient, and more threatening to a physician's professional reputation than background changes in incremental quality.21 payment policies that publicize errors may drive error reporting underground, and may deprive provider organizations of funds needed for improvement. the iom approach also sidesteps a related question: if society learns by paying for performance that some physicians simply do not perform well, what do we do with them? how does p4p tie to licensing and discipline, to weeding out the bad doctors that the public, and for that matter the profession, still very much believe exist, no matter how often patient safety gurus repeat the mantra that most medical errors are committed by good doctors rather than by bad doctors?22 b. competition as befits its moniker, p4p has a business pedigree, with some of its earliest and strongest proponents representing corporate health care 18. lnst. of med., crossing the quauty chasm: a new health system for the 21st century (200 1) [hereinafter crossing the quauty chasm]. 19. inst. ofmed., performance measurement: accelerating improvement (2005). 20. chen may yee, healthpartners to withhold payment for surgical errors, minneapolis star tr.rn., oct. 6, 2004, at la; statement of mark b. mcclellan, adm'r, ctrs. for medicare & medicaid servs. to the comm. on senate fin., may 17, 2006 ("as a necessary step toward encouraging better care and lower overall heath care costs, we support further steps such as eliminating payments for 'never events' and want to work with the congress to take such steps."). 21. william m. sage., reputation, malpractice liability, and medical error, in accountabiuty: patient safety andpoucyreform 159 (virginia a. sharpe ed., 2004). 22. robert j. blendon et al., views of practicing physicians and the public on medical error, 347neweng.j.med. 1933, 1935-36, 1938-39(2002); robertpear,pane/ seeks better disciplining of doctors, n.y. times, jan. 5, 2005, at a2l (summarizing the results of a study which found that disciplining incompetent physicians would reduce malpractice litigation). 2006] p4p: witl it work in theory? 311 purchasers.23 unsurprisingly, the payor community expect$ pay for performance to make the health care system more competitive. on this view' conventional reimbursement represents a combination of misguided regulation and the exercise of market power by physicians who have large informational advantages over those who buy their services. breaking this stranglehold by switching to p4p, some might argue, will increase competition and generate the things competition is supposed to bring: lower prices, higher quality, and closer matching of the services provided to the preferences of the people who are going to receive them. however, competition on quality does not model cleanly in economic theory, and competition on medical quality is fraught with additional uncertainty.24 p4p may indeed channel competition in particular quality­ related directions, but it will not necessarily promote overall competition. one concern is that p4p might reduce competition based on price, which is something that consumers also care about. another concern is how much competition will be lost in the process of establishing p4p systems that rely on consistency and uniform application among health care providers for their effectiveness-structures that invite collusion as well as collaboration. that leading safety and quality advoeates within the medical profession are ambivalent about competition in health care-neither 10m report so much as mentions competition oversight through. antitrust enforcement-provides little reassurance that these risks will be taken into account as pay for performance advances. c. consumer-directed care · p4p, notwithstanding its catchy name, trails "consumer-directed care" as the darling oftoday's health policy solipsists. those who believe that the solution to waste in health care spending is to let individuals take charge of their purchasing decisions find pay for performance attractive because it connotes consumer empowerment. it is not clear, however, that substituting formal performance incentives for traditional reliance on physician competence and beneficence will improve the ability of individual patients to make coherent decisions about their treatment. that will happen only ifp4p reliably captures information desired by consumers but otherwise unavailable to them. moreover, consumer-directed care is ·commonly used as a 23. leathermanetal.,supranote 16; vrrroriomaioetal., vawe-~purchasing: a review of the literature (commonwealth fund report no. 636, may 2003), available at http://www.cmwf.org (1asi visited may 17, 2006); roger lowenstein, the quality cure?, n.y. times mag., mar. 13, 2005; at 46. 24. william m. sage & peter j. hammer, competing on quality of care: the need to develop a competition policy for health care markets, 32 mich. j.l reform 1069,.1109-18 (1999); william m. sage, david a. hyman, & warren greenberg, why competition law matters to health care quality, 22(2) healthaff. 31,31 (2003). 312 indiana health law review [vol. 3:303 euphemism for consumer-financed care-people spending their own money, not that of an insurance pool or th.e public.25 a belief in the benefits of self help will not make everyone financially independent. what about people who do not have money of their own to spend? performance is likely to be defined quite differently by a third-party payer than by the actual recipient of services. d. patient-centered care a core attribute ofhigh-quality health care identified by the 10m is that it is ''patient-centered."26 patient-centered care sounds similar to consumer­ directed care, and therefore superficially compatible with p4p, but its connotations are non-financial. patient-centered care can be understood as health care that the patient wants and that has the patient's subjective welfare as the focus of the care delivery experience. patient-centered care contains its own ambiguities. is the notion of patient-centered care an ethical commitment to patient autonomy or an ethical commitment to professional beneficence? one can imagine p4p aligning incentives so as to serve either objective, but not without specific effort and acknowledgment of tensions between them. furthermore, the technical manipulations necessary to devise and implement pay for performance . seem remote from the human touch that motivates interest in patient-centered care. e. evidence-based medicine for thought leaders in the medical quality movement generally, pay for performance is attractive because it can promote evidence-based medicine.27 individual physicians have not responded with alacrity to requests to remedy widespread quality deficiencies in health care that the requesters have documented.28 this has bred cynicism among the policymaking community 25. ·james c. robinson, consumer-directed health insurance: the next generation, health .aff. suppl. web exclusivb; w5 583-w5 590 (2005); phil gramm, why we need medical savings accounts, 330 new eng. j. med. 1752, 1752-53 (1994) (claiming that waste in health care is primarily attributable to the moral hazard of costlessness at the point of service); gerald l. musgrave et al., lunch insurance, 15 regulation 257 (1992) (postulating a growing and wasteful "lunch system." including lunchicare and lunchicaid, if noontime meals were subject to the same moral hazard as health care). but see john a. nyman, the theory of demand for health insurance (2002); john a. n~ is "moral hazard" inefficient?: the policy implicatiom of a new theory, 23(5) healthaff. 194, 194 (2004) (raising the possibility that precommitments to health care spending through insurance are not wasteful but shift dollars to more higbly valued uses). 26. crossing the quauty chasm, supra note 19. 27. stephen m. shortell et al., implementing evidence-based medicine: the role of market pressures, compensation incentives, and culture in physician organizations, 39 med. care 1-62 (2001). 28. blendon, supra note 22; lucian l. leape & donald m. berwick, five years after to err is human: what have we learned?, 2931ama 2384, 2387-88 (2005). 2006] p4p: will rr work in theory? 313 that dollars speak louder than words, and has prompted a search for quality levers with financial consequences. by supplying both buyers and sellers with a pre-fabricated quality purchasing strategy, p4p represents a refinement of the general "business case" that quality gurus had urged, with only limited success, on the private payer community. evidence-based medicine is a worthy goal, as are the others i have mentioned. but the core premise of evidence-based medicine is that scientific best practices exist that need to be more widely applied to clinical care. p4p that advances evidence·based medicine may not serve other constituencies. scientific best practices are not necessarily market--competitive best practices. nor are they necessarily patient--centered best practices. performance-based payment will also need to be calibrated to address each of the three ways in which clinical practices fail to conform to scientific ideals: overuse of medical services, under use of medical services, and misuse of medical services. 29 f. selective contracting pay for performance can be seen as an attempt to resurrect health insurers' and employers' cost--control capacity under cover of the afore­ mentioned "business case" for quality. managed care failed spectacularly in the 1990s because neither consumers nor providers wanted care managed using the blunt instruments available at the time. but the reasons for managing care-rising· cost and declining private sector access-have persisted. p4p may allow private purchasers to manage care in both a politically more acceptable and a substantively more effective fashion. utilization review-refusing to cover what your doctor says you need­ becomes quality review-determining that what your doctor has done is not good enough to warrant full payment. capitation-a form of financial incentive that shifted insurance risk to provider groups that could not bear it without either their solvency or their commitment to quality being compromised-becomes pay for performance that takes explicit account of quality. selective contracting-limits on choice of physician imposed for the financial benefit of insurers-evolves into coverage arrangements that allow access on preferential terms to physicians who are measurably better. g. public purchasing reform pay for performance also gives new life to efforts to make government a more effective purchaser of health care in the medicare and medicaid programs. it is well known that medicare has never been able to obtain the 29. mark r.. chassio & robert w. galvin, the urgent need to improve health care quality: institute ofmedicine national roundtable on health care quality, 280 jama 1000, 1000 (1998). 314 indiana heal til law review [vol. 3:303 price and quality of services for its beneficiaries that its size and sophistication would suggest because government faces political obstacles and legal barriers that do not similarly handcuff private parties. 30 using objective measures of medical quality to determine payment amounts under p4p is likely to provoke less public and interest group resistance than attempting to exert pure financial leverage through administered pricing. government may even be able to back into selective contracting using p4p. historically, it has been nearly impossible for public purchasers to exclude physicians from participation barring fraud or other extreme circumstances. but it might be politically palatable if measurably worse physicians simply receive less money. eventually; however, a difficult challenge for government arises: what to do about physicians (or hospitals) who really do not measure up, and who should get paid nothing rather than just less. h information technology the dominant trend in american health policy has been to increase the supply of medical services, with other social goals such as ensuring broad access largely an afterthought31 p4p is easily appropriated by traditional supply-side forces for a straightforward if limited purpose: financing information technology in the health care system. this account of pay for performance regards the details of p4p as secondary, so long as its implementation requires sponsor organizations and participating providers to invest in electronic health records, computerized patient order entry systems, and other hi-tech tools. these resources may indeed pay long-term dividends in quality and even cost-effectiveness, but the primary objective of those who support p4p on these grounds is simply to induce capital investment in information technology. ill. unify1ng theories of p4p the eight sources of enthusiasm for pay for performance outlined above come from different camps for different reasons with different manifestations. together, they constitute a movement, but a movement without a theory. can one sort their motives and effects into unifying principles, so that supporters from different groups can coalesce around a core notion ofp4p that society might actually carry into operation? to my mind, there are three plausible theories of pay for performance: a measurement theory, a loyalty theory, and a productivity theory. these 30. len m. nichols & robert d. reischauer, who really wants price competition in medicare managed care?, 19(5) healthaff. 30,30(2000); bryan dowd etal.,a tale off our cities: medicare reform and competitive pricing, 19(5) health aff. 9, 9 (2000). 31. lawrence r jacobs, politics of america's supply state: health reform and technology, 14(2) healthaff.i43, 143 (1995). 2006] p4p: wnl it work. in theory? 315 theories are plausible in the sense that if we as a nation, or as a profession, or as a community, decided that this is what we really want to do with p4p, we would have a pretty good sense of bow to do it and of the pros and cons involved. a. defining "performance" in order to appreciate the distinct implications of the three approaches, it is necessary to construct a basic typology of performance metrics. the types of rewardable performance one observes in emerging p4p systems mirror the ambiguities and tensions in the movement. pay for performance consists of financial incentives for measurable quality, but measurable quality can take many different forms. by mentally matching points along the spectrum of potential incentives to the various motivations that exist for p4p, one begins to see the challenges involved in operationalizing a national commitment to paying for performance. applying the traditional donabedian classification ofhealth care quality demonstrates that performance incentives can be structured to further each aspect of quality that donabedian laid out.32 first, one can reward "interpersonal quality," meaning the ability of doctors, hospitals, and other health professionals to connect with patients and make them feel subjectively better. one can reward interpersonal quality using measures of patient satis­ faction, continuity of care, and perhaps patient compliance with recommended treatment. second, one can reward "technical quality," which donabedian breaks down further into structural measures, process measures, and outcome measures. adoption of information technology is one of the structural measures commonly incorporated into pay for performance as it has been evolving. 33 rewards might be based on acquisition of particular computer systems or capacities like electronic medical records or computerized physician or pharmacy order entry, or on telecommunications capability such as instant messaging. process measures are the quality metrics most frequently used in pay for performance systems to date. many p4p programs focus on disease screening and early intervention for preventable illness. some focus on actual treatment of disease in accordance with some notion of"best practice,'' though whether it is conformity with a science-based clinical practice guideline or a cost­ effectiveness standard depends on the context outcome measures also can 32. a vedis donabedian, the definition of quality and approaches to assessment: expwrations 1n quality assessment and monitoring (1980); avedis donabedian, evaluating the quality of medical care, 44 milbank memorial fund q. 166 (1966). 33. rainu kaushal et al., the costs of a national health information network, 143 annals of internal med. 165, 170-72 (2005). 316 indiana health law review [vol. 3:303 be associated with pay for performance systems. some involve avoiding particular complications of medical care such as hospital-acquired infections or readmissions. others assess longer-term; events such as restoration of functional capacity or patient survival. b. measurement theory what i call the measurement theory of pay for performance is fairly common in practice but is not labeled as such. it simply asserts that the goal ofp4p is to make quality measurable. the measurement theory is founded on a view of health care inefficiency that derives from both lack of information and asymmetric information. 34 lack of information means that health care providers do not know how well they are doing for patients, and therefore cannot improve. asymmetric information means that health care providers know how well they are doing, but patients and health care purchasers do not, and therefore cannot choose sensibly among them. structural pay for perf01'dl8dce systems linked· to the adoption of electronic medical records and other sorts of information and communication technologies may begin a cascade of me8surability.3$ measurable quality probably means better quality, although the mechanism for achieving it may vary.36 measurement, particularly measurement that reduces information asymmetry, is a key component of competition-based visions of american health care. in economic terms, competition involving the quality of a good or service is no different than competition based on price, except for the fact that it is harder to measure. if improved measurement capacity allows providers to make credible assertions regarding the quality of the care they deliver, buyers can act on those assertions. so if one can measure quality better, arguably one can channel competition into fostering quality improvement. another reason one· might want to measure quality is to benchmark quality so there can be aggressive price competition. back in those heady days oftheclintonhealthplan,managedcompetitiongurusbelievedthatastandard benefit package with quality metrics and government oversight would make it possible for consumers to comparison shop for health insurance. if one wants better price competitimi for medical care, therefore, one also needs to 34. see wiuiam m. sage, reguloting through information: disclosure laws ond american health care, 99 cowm. l. rev. 1701, 1715-20, 1771-80 (1999). 35. see,e.g.,petewelch&h.gilbortwelch,fee-jor-data:astrategytoopenthehmo black box, 14(4) heai.m aff. 104, 104 (1995) (proposing that medicare pay hmos more for sharing claims and encounter data).· 36. sage, supra note 34, at 1826 (distinguishing eonsumersovereignty ftom ends-forcing regulatory or self-regulatory oversight); see also anne-marie j. audet et al., measure, learn, ondlmprove:physicians'lnvolvememmqualil)'lmprovement,24(3)heai.maff.843,843-44 (2005) (contrasting physicians desire ·for quality-related practice information with their resistance to external disclosure). 2006] p4p: will it work in theory? 317 be able to measure quality. this rationale for p4p, however, must be imple­ mented carefully. one caution is complexity. adding layers of pay for performance incentives to already complicated payment methodologies in health care makes benchmarked price even less transparent to buyers. it may be good to have more information about quality, but it may not be good to combine traditional payment systems with p4p supplements. the other problem with a competition-based rationale for p4p is collusion. if quality measurement is to improve, measurement techniques need to be consistent from provider to provider and payer to payer. but the process of getting everyone on the same page in terms of what they are measuring and how much of a reward they are offering or receiving for an increment of quality may end up dampening competition rather than improving competition. private insurers have been alert to the antitrust risks of agreeing on specific p4p payment amounts, but the health policy and medical professional literature on pay for performance by and large views the development of quality incentives as a cooperative enterprise and seems unaware of the anticompetitive potential of uniformity. the measurement theory ofp4p is also compatible with non-competitive mechanisms for quality improvement. in fact, competition on quality eventually should render explicit p4p superfluous. at the point where providers can make credible quality commitments to purchasers, the need for supplemental p4p recedes and payment terms simply integrate quality considerations with price considerations. however, p4p that furthers measurement can reinforce government regulation or professional self­ regulatory processes even if competition never develops. whether or not the buying public values quality, once regulators or the medical profession can measure quality, they can do something about it directly. if that is the mechanism by which p4p connects measurement to quality improvement, of course, the principal benefits are going to be collective rather than accruing to individual buyers (or to individual sellers anticipating the behavior of those buyers). consequently, economically self-interested parties will not invest enthusiastically in p4p systems because they cannot capture exclusive returns from them. a national commitment to make quality measurable through pay for performance may require public investment. c. loyalty theory another plausible theory of pay for performance, though one that is harder to implement, can be called the loyalty theory. the loyalty theory grows out of the managed care experiences of the 1990s, which introduced into the health care system a host of what economists and legal scholars call 318 indiana health law review [vol. 3:303 "agency costs.'m instead of a dyadic relationship between a single consumer (the patient) and a single provider (a physician or perhaps a hospital), with care usually financed by a passive third party payer (a health insurer), there are various intermediaries offering or receiving financial incentives that create competing loyalties. 38 insurers, now called managed care organizations, actively negotiate fees with providers and monitor care ~t is given to beneficiaries. "usual and customary'' fee-for-service reimbursement gives way to discounts, withholds, capitation, and a host of mixtures. 39 some providers join fqrces with payers to form integrated enterprises, while others create consolidated entities or common contracting vehicles to improve their financial leverage. a consequence of· this activity was to erode, or at least create the appearance of eroding, longstanding fiduciary obligations running from doctor to patient. paying physicians for performance, like paying lawyers contingent fees, is a superficially appealing way to restore traditional ethical values by aligning incentives between provider and patient. think about it as a goldilocks storythe search for the '~ust righf' compensation package. if fee-for-service induces too much treatment, and capitation induces too little treatment, where should dr. goldilocks sleep? policymakers continue to seek a payment formula that will reinforce both medical science and fiduciary obligation. in the midst of the national health reform debate in 1993, for example,.jama published an article proposing "fee for time" as an "incentive-neutral" system. 40 i assign the article to my professional responsibility students because it is so charmingly naive. any lawyer (or client) held hostage by billable hours understands the perverse incentives that a fee for time system can create. is pay for performan~ the holy grail for physician payment? will it perfectly align physician behavior with patient desires? probably not. rewarding physicians for improving interpersonal quality using metrics such as patient satisfaction surveys does seem loyalty-enhancing. defenders. of patient autonomy would agree that what the patient subjectively experiences from medical care is an appropriate basis for physician payment. p4p based on hard measures of clinical outcomes (technical quality) also furthers loyalty to patients. if we reward physicians for curing patients, the patients who 37. marc a. rodwin, medicine, money & morals: physicians' conflicts of interest (1995). agency costs have long been a concern of scholars qf corporate governance. michael c. jensen & william h. meckling, theory of the firm: managerial behavior, agency costs and ownership structure, 3 j. fin. econ. 305 (1976). 38. lawrence casalino, managing uncertainty: intermediate organizations as triple agents, 26 j. health pol. pol'y & l. 1055, 1055-57 (2001 ). 39. jon gabel, ten ways hmos have changed during the 1990s, 16(3) health aff.l34,140-41 (1997); robert a berenson, beyond competition, 16(2) healthaff. 171, 177-78(1997). . 40. tomj. wachtel & michael d. stein, fee-for-time system: a conceptual framework for an incentive-neutral method of physician payment, 270 jama 1226, 1226-29 (1993). 2006] p4p: will it work in theory? 319 receive treatment from those physicians will be well cared for (we will return to the issue of patients who have trouble finding a physician willing to serve them under those financial conditions). on the other hand, process-based p4p-the most common form of pay for performance currently being implemented-has ambiguous implications for physician loyalty. process-based p4p is basically compliance with rules. someone has to set those rules, and it is not going to be the patient. maybe third-party payers will set the rules, maybe scientific and professional bodies will set the rules, maybe government will set the rules. but the patient won't. physicians who earn process-based p4p rewards, therefore, will likely be furthering collective interests of public and private payers in cost-effective care for populations of enrollees.41 if these types of metrics dominate, the loyalty effects of pay for performance are not going to be that different from the loyalty effects of managed care. i was a cautious supporter of managed care in the 1990s, and p4p may bring out some of the better qualities of managed care. however, it will do so by refining managed care, not by superimposing a payment formula that obviates conflicts of interest or obligation.42 d. productivity theory the third plausible theory of pay for performance is the one that i think has the. greatest potential payoff. predictably, it is also the one that presents the greatest challenges for the next ten years. the idea of what i call the productivity theory of pay for performance is that setting up the incentives correctly will induce american medicine to get better at its job. increasing productivity through p4p can be slow or rapid. one approach is to produce productivity gains without massive industry restructuring.43 that is probably what we are attempting right now. most p4p programs seek to make doctors practice better but not fundamentally change the way that medical practice is organized. they reward the acquisition of basic information technologies. they make incentive payments for compliance with professionally determined, consensus best practices that are broadly acceptable to physicians. they key payment to process measures that can be verified using standard insurance claims data, and do other things that are not 41. a compromise approach to p4p intended to reward comprehensive, complete care rendered to individual patients has been proposed. see thomas nolan & donald m. berwick, all-or-none measurement raises the bar on petformance, 295 jama 1168 (2006). 42. e. haavi morreim, benefits decisions in erisa plans: diminishing deference to fiduciaries and an emerging problem for provider-sponsored organizations, 65 tenn. l. rev. 511, 523-34 (1998). 43. see robert cunningham, professionolism reconsidered: physician payment in a small-practice environment, 23(6) health aff. 36, 46 (2004) (urging the development of quality-based payment systems that accommodate the persistence, and perhaps the nonnative desirability, of small-group practice). 320 indiana health law revlew [vol. 3:303 too intrusive or too. costly· to participating physicians in the hope of stimulating incremental improvement.'" but the dividends from this type of productivity-based p4p. will be limited. the problem is that there are trade-off's between how easily we can get the information on which we are basing performance incentives and how useful that information really is. we also will not be able to incorporate many outcome-based p4p measures because outcome measurement requires pooling large numbers of patients to achieve statistical validity and being able to confidently attribute higher or low~ performance accurately to the person or entity actually responsible for it. the more one segments a patient's experience among different providers offering different services at different times, the less likely it is that outcomes can ·be measured reliably and usefully.45 a related problem is that ·individual physicians have limited authority to command resources for which they do not directly pay. unlike lawyers receiving contingent fees, who beyond the opportunity cost of their own time have at most to advance expenses for expert witnesses, a physician who truly wanted to improve outcomes would have to front hospital, pharmaceutical, and other hard costs that far exceed the potential personal financial gain from success. how might medicine improve more rapidly? primarily by becoming more integrated, more coordinated, and larger scale than it currently is.46 the persistent fragmentation of medical practice in this country is its greatest barrier to improvement. american health care is the world's largest cottage industry. changing this-something that pay for performance may be able to do if its proponents attempt it-is likely to have the greatest measurable benefits in terms of quality improvement and cost effectiveness.47 44. see pacific business group on healm, advawcjnq physician performance measurement: usingadministaativedata toassessphysicjanquaiiiy andemciency (sept. 2005), available at http://www.pbgb.org (last visited may 17, 2006). 45. a weak compromise is to reward participation in quality improvement programs regardless of short-term measurable change. see nancy j.o. birkmeyer & john d. birkmeyer, strategies/or improving surgical quality-should payers reward excellence or effort?, 354 new enol j. med. 864 (2006). 46. see crossing the quau1y chasm, supra note 19 at 61-88 (bighligbting coordination and cooperation as keys to improvement); joseph r. newhouse, why is there a qualitychasm?,21(4)healthaff.l3,22(2002)(11gr'eingwitbthe(lualitychasmreportbut describing "even more fundamental" barriers to good performance tban lack of organized systems); diane r. rittenhouse et al.. physician organization and care management in califomia:fromcottagetokaiser,23(6)healthaff.si,s8-s9(2004)(reportinggreateruse of quality tools in hmo practice settings). but see judith smitb & kieran walshe, big business: the corporatlzation of primary care in the uk and the usa, pub. money & mgmt., apr. 2004, at 87 (asserting tbat tightly organized primary care is unsuccessful). 47. see. e.g., robert s. huclanan & gary p. pisano, the firm specificity of individual performance: evidence/rom cardiac surgery, 52 mgmt. sci. 473,484-85 (2006) (finding that surgeon performance is largely dependent on hospital-specific characteristics). 2006] p4p: will it work in theory? 321 for this purpose, outcome-based pay for performance is clearly superior. outcome measurement with significant rewards attached to improvement will force providers to coordinate and combine their practices so that they can take collective responsibility for success and collectively share the rewards. 48 it remains to be seen, however, whether the political influence of fragmented provider organizations will retard the implementation of this type of p4p if proposed by government payers, or whether the public will accept integrated organizations bmught into existence through private p4p more readily than they did traditional hmos. one unanswered technical question for p4p intended to induce organiza­ tional change, beyond the practice restructuring itself, is how financial rewards for productivity gains get distributed internally within the organiza­ tions that receive them.49 the california experience with pay for performance is instructive because capitated medical groups made much greater headway there in the 1990s than elsewhere.5° california p4p programs have two distinct components: the method by which payers structure incentives for the medical groups, and the manner in which the medical groups divide those rewards among their employed or affiliated physicians. this observation has a further implication for the design of p4p programs. for productivity gains that do not involve practice consolidation and industry restructuring, modest amounts of cash may go a long way and unanticipated consequences should be minor. individual professionals, like all small businesspeople, respond well to small cash incentives. this seems to be the experience in england, where general practitioners enthusiastically agreed to various process measures in exchange for a pay increase. by contrast, performance rewards for corporate entities must be orders of magnitude greater to attract participation by senior executives, who then must be willing to create internal incentives for middle managers and front-line care providers who are precluded from accepting direct payment from outside the organization. experience with incentive stock options and other performance­ based executive compensation packages in fortune 500 corporations suggests that these programs have both benefits and risks. major corporate scandals involving fraudulent "earnings management" and share price manipulation are 48. this is why federal antitrust enforcers regard pay for performance as a potential indicator of either clinical or financial integration, sufficient in many cases to immunize provider collaboration from per se condemnation under the sherman act. william m. sage & dev n. kalyan, horses or unicorns: can payingfor performance make quality competition routine?, 31 j. health pol. pol'y &l. 529,536-39 (2006). 49. inst. of med., crossing the quauty chasm, supra note 19, at 28-30, 111-44; meredith b. rosenthal et al., transmission of financial incentives to physicians by intermediary organizations in california, 21(4) healtiiaff.197,197-98 (2002). 50. jambs c. robinson, the corporate practice of medicine: competition and innovation in healtii care (1999); robin r. gillies et al., how different is california? a comparison of u.s. physician organizations, healthaff. suppl. web exclusive, w3 492w3 502 (2003). 322 indiana heal1h law review [vol. 3:303 clear evidence that rewarding senior executives for short-term gains in market capitalization did not align management and shareholder incentives exactly as intended. e. the government's role pay for performance is often described as an innovation in private health care purchasing-an example of managed care learning how to do what it wants to do better. nonetheless, i believe government has a central part to play, and i am heartened by the fact that the bush administration has been aggressively promoting p4p in the medicare program. there are three aspects to the government's rqle. there is the govern­ ment's role as purchaser through medicare and medicaid, the government's role as regulator, and-though there is not a perfect way to describe this-the government's potential role as guarantor of access to health care and health insurance. each aspect has implications for the design and implementation of pay for performance. government can do very well as a purchaser because of the scale and visibility of medicare. first, medicare is so big that it can produce modal change in health care quality rather than marginal change .. economists focus on differences at the margin-turning a lower quality provider into a higher quality one because of the new incentive structure-but quality control is so poorly developed in medicine that p4p must improve the average experience of patients. only very large payers can accomplish that. second, medicare can encourage provider integration without completely compromising physician morale. empirical research suggests that large organizations deliver better medical care than small organizations. st however, it also appears that physicians are less satisfied practicing in settings that limit their clinical autonomy, which may include large organizations.s2 medicare can ease this tension through its support for medical education and training. over the long term, only improved education and generational change in the professions will allow practice restructuring to happen in american medicine in a beneficial rather than a counterproductive fashion. third, government can pay for public goods and partial public goods. as described above, many benefits of establishing the infrastructure to respond to p4p are collective rather than individual. in the united kingdom, the nhs obtained buy-in for its general practitioner pay for performance requirements by offering physicians an overall increase in compensation.s3 by 51. edward l. halinan, the relation between volume and outcome in health care, 340 neweng.j.med.l677, 1677-79(1999). 52. bruce e. landon et al., changes in career satisfaction among primary care and specialist physicians, 1997-2001,289 jama 442, 442 (2003). 53. peter c. smith, petformance management in british health care: will it deliver?, 21(3) healthaff. 103, 103 (2002). 2006] p4p: wnl it work 1n theory? 323 contrast, a private insurer would be hard pressed to justify increased compensation simply because providers are now demonstrably delivering the results they have always promised. a significant caution is that health care is such a huge slice of the federal budget that additional appropriations tied to p4p may encounter political resistance. large-scale changes in medicare payment are less driven by health care politics than by general fiscal and tax politics. for example, hospitals have had only modest success defending their medicare reimbursement because even· small changes in hospital payment have significant budgetary consequences. 54 what can government do as regulator? pay for performance is a fairly standard type of regulatory intervention. it sits somewhere in between a mandatory information disclosure law ("tell us and the world how you are doing but nothing more is required'') and a command-and-control standard ("tell us how you are doing and we'll tell you if you need to do better, and how"). in p4p, financial inducements make disclosure more likely, and quality metrics make disclosure more meaningful, but do not constitute mandatory standards. for example, financial incentives to adopt information technology may prove more effective, and more politically achievable, than a direct mandate. another function ofp4p will be to focus government on the detrimental consequences of some of its prior regulation. medical regulatory policy in this country has always preserved physicians' prerogatives both as ethical professionals and as small businesspeople. pay for performance will force government at various levels to rethink that jeffersonian commitment. medical regulation, notably professional licensing but also managed care regulation, has also discouraged consumers from accepting tradeoffs between price and quality in medical care. 55 p4p clearly contemplates paying more for better medicine and less for worse medicine, a bow to economic reality that may spill over and loosen restrictions on private contracting for medical care. finally, pay for performance should attract greater scrutiny from the federal antitrust enforcement agencies. both private and government sponsors ofp4p have considered its regulatory interactions with federal fraud and abuse law, and with federal and state tax-exempt organization law. it is equally important for government regulators to assure that pay for performance does not evolve so as to reduce competition in american medical care. let me conclude by mentioning government's role in assuring broad public access to medical care. lack of health insurance and health care is a much larger and more pressing problem in american society than poor medical quality for those who are well insured. unlike lawyers' contingent 54. bruce c. vladeck, thepoliticaleconomyofmedicare,l8(l)healrnaff.22,22 (1999). 55. clark c. haviohurst, health care choices: private contracts as instruments of realm reform (1995); james f. blumstein, health care law and policy: whence and whither?, 14 healtiimatrix 35, 38-39 (2004). 324 indiana heal1h law review [vol. 3:303 fees, medical pay for performance does not automatically improve access to professional services~ and may have the opposite effect.56 iil addition to providing incentives to work bard and to work cost effectively for clients, contingent fees in litigation induce lawyers to take winnable rather than non­ winnable cases, and allow poor people who could not afford to pay hourly fees to receive legal services. medical p4p does not generate funds for indigent care. a poor patient "recovers" health, not money, and any payment that rewards recovery must come from elsewhere. moreover, pay for performance creates uncomfortable selection dynamics with respect to the types of cases that physician and hospitals will be willing to undertake if payment depends on successful outcomes. in law, contingent fee payment discourages frivolous litigation (setting aside its risk of provoking lawyers to act unethically when pursuing settlement) because a lawyer does not get paid for losing. however, society's interest in health care is not limited to the curable case. nor should physicians be rewarded for treating the healthy or those with self-limiting disease. society's commitment is to do the best for every patient, particularly patients with grave illnesses who crave hope and compassion. government is likely to be in a stronger position than private payers to assert these interests when designing and monitoring pay for performance systems. n. conclusion since the spectacular failure of national health reform in the early 1990s, it is rare than any health policy prescription generates widespread enthusiasm. pay for performance makes a very short list of innovations with broad-based support. with planning, and luck, p4p may contribute significantly to improving the quality of medical care. to do so, however, it needs a more clearly articulated theory than has been the case thus far. that theory, moreover, must assert a leading role for government. performance-based payment will not automatically link financial flows in health care to desirable social outcomes. in particular, neither active quality competition nor quality­ related productivity gains apart from competition will resolve daunting problems of access and affordability in american health care. it has been my pleasure to welcome you to the pay for performance medical quality movement. and remember---all you have to do to join is to sing it the next time it comes around on the guitar. 56. see william m. sage, physicians as advocates, 13 hous. l. rev. 1529, 1624-25 (1999). combating obesity: our country's need for a national standard to replace the growing patchwork of local menu labeling laws ashley arthur* i. introduction ............•..........................................•......•................ 306 ii. caloriesonmenusasa waytocombatthegrowing .......•.... obesity problem ............ ····· ...................................•.................... 307 a. fast food consumption correlates with obesity ................... 307 b. posting nutritional information at the point of purchase would help consumers make informed, healthier food choices ..... 309 c. menu labeling at the point of purchase is similar to nutrition labeling under the nutrition labeling and education act of 1990 (nlea) ............................................................................ 312 iii. menu labeling legislation: an overview ............................ 313 a. new yorkcity .......................................................................... 314 b. california local patchwork preempted by new state wide legislation ............................................................................... 316 c. king county (seattle), washington .......................................... 318 d. philadelphia ............................................................................. 318 e. indiana: pending legislation .................................................. 319 n. argument for a national standard ..................................... 320 a. the labeling education and nutrition act of 2008-proposed national measure .................................................................... 322 b. the coalition for responsible nutrition information (crni) ...................................................................................... 322 v. argument for a uniform standard at the state level. ... 324 a. the nlea does not regulate nutrition information labeling on restaurant food, and states and localities are free to adopt their own rules ...................................................................... 324 vi. policy in favor of menu labeling legislation ................... 325 vii. policy arguments against menu labeling legislation ... 326 viii. possible constitutional challenge to menu labeling legislation-infringement of commercial speech .............. 327 a. central hudson gas & electric corp. v. public service commission ............................................................................. 328 1. nutrition disclosure concerns lawful activity and is not misleading ......................................................................... 329 2. the government's interest in public health is substantial ......................................................................... 329 * j.d. candidate, 2010, indiana university school of law-indianapolis; b.a., 2006 indiana university. 306 indiana health law review [vol. 7:305 3. the restriction directly serves the asserted interest··'···· 331 4. the restriction is not more extensive than necessary .... 331 ix. conclusion .................................................................................. 332 i. introduction menu labeling laws are an attempt by the government to reduce one of american society's most significant health issues: obesity. these laws, which target restaurants, typically apply only when a restaurant reaches a certain size, such as chain restaurants. therefore, the laws have a tremend­ ous impact on fast food restaurants. for example, in new york city, where menu labeling legislation has been in place since 2008, restaurants that are part of a national chain of fifteen or more restaurants are required to provide nutritional information on menu boards, menus, or food item display tags for standard menu items. 1 this legislation affects larger chain restaurants, opposed to the local and small mom and pop restaurants, because these mega-chains are better suited to absorb and administer the burden of com­ plying with the menu labeling requirements. these laws are intended to increase customer awareness about calories and composition of the foods they purchase. the premise behind these laws is that a consumer should be provided with nutrition information in clear, accessible ways at the time the food is ordered, rather than force the con­ sumer to research that information which, if posted at all, will only be found on the restaurant's website or a pamphlet that is completely disassociated from the menu. fast food is generally unhealthy and leads to obesity, but many people are unaware of the detrimental effects of this food, and only in recent years have consumers even started to ask restaurants about the calor­ ic content of the foods they sell. menu labeling laws permit the customer to make an informed decision about the food selected. they do not operate as a ban on fast food consumption or to prevent people from eating fast food. as will be discussed in this note, it is often difficult to tell how unhealthy something is for you, and food items that sound healthy may actually be very unhealthy. further, most americans eat fast food on a regular basis. if customers are able to utilize nutritional information on their menus to order food that contains fewer calories and fat, the obesity problem as a na­ tional crisis may be reduced, if not eliminated entirely. menu labeling laws are not a new concept but have just begun to be implemented in recent years. maine was the first to introduce menu. labe­ ling legislation. new york city was the first to pass such legislation, fol­ lowed by philadelphia and various counties in california. california 1. california center for public health advocacy, nutritional labeling in chain res­ taurants: state and local bills/r.egulations-2007-2008, at 2, http://www.cspinet.org/ nutri­ tionpolicy/menulabelingbills2007-2008.pdf (last visited aug. 16, 2009) [hereinafter "ccpha nutrition labeling in chain restaurants'1. 2010] combating obesity 307 recently became the first state to pass statewide legislation that preempts local city and county menu labeling laws. this note will examine current menu labeling laws and argue that menu labeling laws for fast food and other chain restaurants should be im­ plemented to address public health concerns related to obesity in american society. section ii addresses how including nutrition information on menus will combat the country's growing obesity problem. section iii states an overview of current menu labeling legislation. section iv argues that a na­ tional menu labeling standard is necessary, because providing nutrition in­ formation on a city-by-city or state-by-state basis creates a patchwork quilt of confused and contradictory local regulation that fails to adequately pro­ vide detailed nutrition information to the american consumer. section v sets forth arguments for uniform statewide standards as a short-term solu­ tion or possibly as a complete alternative to a national standard. sections vi and vii provide legal and policy arguments for and against menu labe­ ling legislation. section viii discusses potential constitutional challenges that opponents of menu labeling legislation might assert. section ix con­ cludes and summarizes arguments in favor of a national standard for menu labeling legislation. ii. calories on menus as away to combat the growing obesity problem a. fast food consumption co"elates with obesity obesity has skyrocketed in the united states over the last three dec­ ades. in the mid-1970s, fifteen percent of the adult population in our coun­ try was obese. now, more than thirty-three percent of adults suffer from obesity.2 this statistic is troublesome for people who care about staying fit but worse are the financial implications of these obesity statistics, particu­ larly health care costs. the increasing level of obesity in our country "is a ticking time bomb for the [american] health care system."3 obesity increases the risk of heart disease, hypertension, high cholesterol, type 2 diabetes, and cancer.4 obese children are very likely to become obese adults and suffer :from more im­ mediate adverse health effects, including the aforementioned conditions and "insulin resistance, orthopedic problems, liver damage, sleep apnea, and 2. merrill goomer, public health advocates prepare for another calorie battle: push for restaurants to put calories on menus as a way to combat the growing obesity problem, healthcare j.of northern california, winter 2007, http://www.hcjnc.com (last visited oct. 2, 2008); see also cynthia l. ogden et al.,the epidemiology of obesity, gastroenterology 132, 2087, 2087 (2007). 3. goomer, supra note 2. 4. see goomer, supra note 2. 308 indiana health law review [vol. 7:305 asthma. ,,s obese children are also likely to be the target of stigmatization and discrimination, and to suffer from low self-esteem and depression.6 a 2005 study by the centers for disease control and prevention estimated that approximately 112,000 deaths in the year 2000 were associated with obesity in the united states.7 in new york city, for example, diabetes has more than doubled in the past decade, and hospitalizations for long-term complications of diabetes have been rising steadily.8 these health issues put a strain on our country's health care system, which is a cost carried by our society as a whole. according to at least one study, increasing obesity rates and associated health problems create skyrocketing health-care costs.9 americans are eating out at a rate twice that in the 1970s. "in 2006, americans spent almost half ( 48 percent) of their food dollars on foods pre­ pared outside the home, in comparison to 26 percent in 1970."10 this in­ crease in consumption of away-from-home foods has been facilitated by the expansion of restaurant chains and fast food restaurants. 11 "[f]requent intake of fast food has been associated with increased ca­ lorie intake, weight gain ... and obesity."12 when people eat out they are more likely to eat larger portions, thus consuming more calories than they would by preparing food at home.13 just one meal ordered in a fast food 5. paul simonet al., county of los angeles dmsion of chronic disease & injury prevention, menu labeling as a potential strategy for combating tim obesity epidemic: a health impact assessment 2 (2008), available at publi­ chealth.lacounty.gov/docs/menu _labeling_ report_ 2008.pdf (last visited march 1, 2009). 6. /d. 7. katherine m. flegal et al., excess deaths associated with underweight, over­ weight, and obesity, 293 jama 1861, 1863-64 (2005). 8. dept. of heaith and mental hygiene board of health, notice of intention to re­ peal and reenact §81.50 of the new york city health code 4 (jan. 22, 2008), available at http:/ /www.nyc.gov/html/dohldownloads/pdfi'public/notice-intention-hc-art81-50-1 007 .pdf· [hereinafter ''notice of adoption'1. · 9. see eric a. finkelstein et al., state-level estimates of annual medical expendi­ tures attributable to obesity, 12 obesity research 18, 22-23 (2004) (listing increased annual medical expenditures of states attributable to obesity in several states, including new york where medical expenditures attributable to obesity totaled over $6 million from 1998 to 2000). 10. dr. robert c. &veronica atkins center for weight & healtii, university of californiaberkley, potential impact of menu labeling of fast foods in california 1 (2008) (citation omitted) [hereinafter "center for weight & health'1. 11. /d. at2 in a 2007 consumer survey of californians 16-64 years of age, 82% of californian adults in the five largest market areas in california ... made fast food purchases at least once per month. these fast food consumers made fast food purchases an average of 14.9 times per month, the equiv­ alent of3.4 times per week. 12. mary t. bassett et al .• purchasing behavior and calorie information at fast-food chains in new york city, 2007,98 am. j. of pub. health 1457. 1457 (2008). 13. /d. at 1458 ("fast food, which represents approximately 74% of all restaurant traf­ fic nationally, typically contains more calories per serving than does food prepared at home."); see also goozner, supra note 2. 2010] combating obesity 309 restaurant might contain more calories than the recommended daily caloric intake for the consumer. further, portion sizes at fast food restaurants have increased over time, an increase that parallels the obesity epidemic.14 "ac­ cording to a recent national survey, over one quarter ... of adults eat fast food on any given day, consuming approximately 200 calories more on days when fast food is eaten. "15 in sum, people are eating fast food more often and consuming more calories, on average, than they ordinarily would at, home. chain restaurants serve food associated with excess calorie con­ sumption and weight gain. therefore, it is important for consumers to know what they are consuming when they go out to eat. even more impor­ tant is the recognition of a correlation between fast food consumption and growing obesity rates, because there will be substantial long term costs to our health and wallets if action is not taken sooner than later. b. posting nutritional information at the point of purchase would help . consumers make informed, healthier food choices fast food chains should display calorie information prominently at the point of purchase where it can be seen and used to inform purchases. ''without nutrition information at the point of decision-making in chain res­ taurants, it's hard for people to make informed choices for themselves and their children," according to margo g. wootan, director of nutrition policy at the center for science in the public interest (csp1).16 nutritional infor­ mation, however, is not always readily available to customers until after they order. 17 many restaurants currently disclose nutritional information in brochures, tray liners, or post information online, but such measures are inadequate if people can not use the information when they are actually de­ ciding what to order. in fact, in its notice to adopt menu labeling legisla­ tion, the new york city department of health and mental hygiene board of health noted that voluntary activities by restaurants were "woefully in­ adequate," failed to inform the vast majority of customers, and "ha[d] little or no impact on choice."18 for example, the majority of people dining in new york city restaurants did not even notice caloric information when the 14. notice of adoption, supra note 9, at 4 ("[s]ince the 1970s, the typical serving size for soft drinks increased by 49 calories, for french fries by 68 calories, and for hamburgers by 97 calories" (footnote omitted)). 15. center for weight & health, supra note 11, at 2 (citation omitted). 16. center for science in the public interest, california legislature passes historic menu labeling bill: governor schwarzenegger urged to make california first state to require nutrition info, cspi newsroom, sept. 11, 2007, http://www.cspinet.orglnew/ 2007091111.html (last visited march 17, 2010) [hereinafter "historic menu labeling bilf1. 17. california center for public health advocacy, menu labeling poll: californians overwhelmingly support mandatory menu labeling, http://www.publichealthadvocacy.orgl menulabelingpoll.html (last visited aug. 16, 2009) [hereinafter "ccpha californians sup­ porf'j. 18. notice of adoption, supra note 9, at 8. 310 indiana health law review [vol. 7:305 information appeared on a counter mat, wall or poster, or the restaurant website.19 on the other hand, when people see nutrition information at the point of sale, just before ordering, it has been shown that those individuals order meals containing fewer calories.20 health experts project that man­ dated menu labeling for fast food and other large chain restaurants "would prevent [approximately] 38.9% of the annual weight gain in the country,'m even if consumers make only small changes during the decisionmaking process. 22 in fact, . researchers believe that preventing ·annual weight gain can be achieved if menu labeling caused only ten percent of restaurants pa­ trons to order meals with 100 less calories.23 having nutritional information displayed on the menu helps consum­ ers exercise personal responsibility when ordering because restaurant cus­ tomers no longer have to guess what is in their meals. the legislative history of.the california senate recognized the importance of nutritional information in helping customers make informed decisions about their health and diet.24 informed decisions throughout one's daily dietary deci­ sions can literally save "hundreds, even thousands, of calories."25 a 2007 study regarding purchasing behaviors and calorie information at new york city fast-food chains found that when fast food chains provide its patrons with prominent calorie information prior to purchase, many cus­ tomers wm.use· that information to reduce their caloric intake.26 in the study, less than five percent of fast food customers saw the nutrition infor­ mation before they ordered.27 this statistic, however, did not include sub­ way customers, who reported seeing the nutrition information prior to ordering and consequently purchasing fifty-two fewer calories than those who did not see the information.28 "[o]ver one-third of ... subway [custom19. ccpha californians support, supra note 18; bassett et al., supra note 13, at 1458-59. 20. ccpha californians support, supra note 15; bassett et al., supra note 10, at 1459. 21. ccpha californians support, supra note 15; see also simon, supra note 5, at 1 (suggesting· that increased caloric intake accounts for the average annual weight gain of al­ most seven million pounds in the u.s. population). · 22. simonet al.; supra note 5, at 1; see also center for weight & health, supra note 11, at 6 ("if 80% of adult customers notice calorie information on menu boards in cali­ fornia, and reduce calories in their purchases by 52 calories per visit, for example, this could result in an average annual weight gain avoided of2.1 pounds per adult who frequents fast food restaurants.") 23. simon et al., supra note 5, at 1. 24. s.b. 120 bill analysis at 3, january 8, 2008, available at http://info.sen.ca. gov/pub/0708/bil1/sen!sb_ol010150/sb_120_cfa_20080108_154841_sen_floor.html. 25. maryclaire dale, a philly cheesesteak, with a healthy side of new law requires eateries to serve info on calories, fats and sodium, the star-ledger, dec. 20, 2008, at 12 .. 26. bassett et al., supra note 13, at 1457. · 27 .. · id. at 1458. 28. !d. (''patrons purchased a mean of 827 calories, with 34% purchasing 1000 calories or more, and 15% purchasing 1250 calories or more"). 2010] combating obesity 311 ers] reported that this information affected their purchase."29 on the other hand, there was no significant difference in mean calories purchased by cus­ tomers who saw the nutrition information, but decided not to use it, and customers who never saw the information?0 some people simply do not care about the amount of calories they consume, but one-third of the cus­ tomers did care and used the information to order menu items with fewer calories. "given the frequency of fast food consumption, even modest re­ ductions in calories (e.g., fifty calories per meal) could significantly reduce the country's overall caloric intake."31 moreover, as consumers select those menu items containing fewer calories, it follows that, over time, restaurants will modify their menus and offer the lower-calorie foods most requested by their customers. another reason to place nutrition information at the point of purchase is that many consumers often underestimate the caloric content of food, and could "benefit from having readily accessible information on the calorie content of menu items."32 moreover, increasingly larger portion sizes in restaurants make it difficult for a consumer to determine the nutritional con­ tent of a meal and how many servings a single portion really contains. sim­ ilar items can differ greatly in size, even at the same chain, and there is a wide range of calories contained seemingly identical products.33 people are likely to underestimate the amount of calories they consume when they eat out, especially if they think that they have made healthy food choices.34 even "healthy" choices, however, are oftentimes only health when com­ pared to other menu items and vary in their nutritional value. many cus­ tomers concerned about their health may order a menu item that seems healthy but may be surprised to know the truth, as "differences in calories among various options are not always intuitively obvious." 35 for example, a starbucks reduced-fat turkey bacon, cholesterol-free egg, reduced­ fat white cheddar breakfast sandwich contains 350 calories and eleven 29. id. at 1458. 30. id. 31. id. at 1459. 32. simon et al., supra note 5, at 2-3 (citations omitted); see also s.b. 120bill analysis, supra note 24, at 5. 33. see e.g., simonet al., supra note 5,. at 7 ("[c]hanging from a double meat patty to a single meat patty hamburger would save 244 calories, from a large to a medium order of french fries would save 163 calories or from a large to medium soft drink would save 95 calories."). 34. see goozner, supra note 2.; see also california center for public health advoca­ cy, california leads nation with passage of menu labeling law, bus. wire (sacramento, ca), sept. 30, 2008, http://www.businesswire.com/news!home/20080930006295/en ("[a] statewide field research corporation poll was released showing that only 10 percent of californians could pick the healthiest item from a short list of common fast foods") [herei­ nafter "ccpha california leads nation"]. 35. notice of adoption, supra note 9, at 6 ("even experienced nutrition professionals have difficulty accurately estimating the calorie content of restaurant food. in one study, these professionals underestimated calories in restaurant food by 200-600 calories"). 312 indiana health law review [vol. 7:305 grams of fat, while a lowfat blueberry muffin has 300 calories, and five grams of fat.36 if caloric information was made readily available prior to ordering,. a patron would realize the difference of the nutritional value of these items. furthermore, the starbucks consumer would know that the perfect oatmeal, at 140 calories and approximately two grams of fat, is sig~ nificantly healthier than either of the other two ''healthy'' options. . by choosing the oatmeal, this customer cuts 210 calories and almost nine grams of fat out of his or her breakfast, but the customer will not have this information to make these decisions if it is not clear at the point of pur­ chase. c. menu labeling at the point of purchase is similar to nutrition labeling under the nutrition labeling and education act of 1990 (nlea) for over a decade, the fda has required, by law, nutrition labeling of packaged foods.37 nlea, which generally prohibits misbranding of food, requires sellers of packaged food and beverages to disclose the ingredients contained in the product and place a standardized nutrition facts panel on the packaging. 38 food manufacturers are required to disclose the amount of ''fat (saturated and unsaturated), trans fat, cholesterol, sodium, potassium, carbohldrates, dietary fiber, sugar, protein, as well as calories in their prod­ ucts.',) anyone who has bought groceries has likely looked at nutrition la­ bels when buying food at the grocery store. although nlea controls disclosure of nutritional information on packaged foods, restaurants are exempted from these standards.40 thus, nlea does not preempt other governments, state or federal, from imple­ menting similar standards.41 moreover, nlea provides a practical frame­ work for nutrition disclosure for restaurant food, and .. is an approach consumers across the country have used effectively for more than [eighteen] years.'"'2 the coalition for responsible nutrition information (crni) was recently formed to promote the expansion of flexible federal legislation, specifically through the expansion of nlea to include more detailed nutri­ tional information for food sold nationwide by major chain restaurants.43 36. starbucks coffee, nutrition information, http://www.starbucks.com/retail/ nutrition_fteshfood.asp (last visited aug. 16, 2009). 37. see center for weight & health, supra note 11, at 4. 38. nutrition labeling and education act of 1990, 21 u.s.c. §343 (2000). 39. the coalition for responsible nutrition information, frequently asked questions about food and nutrition facts, http://www.nationalnutritionstandards.com/faq.html (last visited aug. 16, 2009) [hereinafter "crni faqs"]. · 40. jennifer pomeranz & kelly brownell, legal and public health considerations affecting the success, reach, and impact of menu-labeling laws, 98 am. j. of pub. health 1578, 1579 (2008). 41. id 42. crni faqs, supra note 40. 43. ld 2010] combating obesity 313 this note will discuss the crni in greater depth in section n. one can analogize between putting a restaurant's nutrition information at the point of purchase and labeling food products sold in a grocery store. after all, most menu labeling laws require the same factual information that nlea requires food producers to disclose, such as the amount of calories and fat in a particular food item. 44 further, people tend to study and com­ pare nutrition facts before they put the item in their cart or during check­ out. similar to consumers making food choices in a grocery store, restau­ rant customers should be able to fully evaluate and compare their food choices before making a purchase. nutrition labels are important because, as studies show, people use the information contained in those labels to help them make decisions about what to eat. "three quarters of american adults report using food labels, and about half ( 48%) report that nutrition information on food labels has caused them to change their food purchasing habits. "45 therefore, it is like­ ly the same will be true if chain restaurant customers are able to see nutri­ tion information before ordering. people are still purchasing groceries and will most likely continue to purchase fast food. if nutrition facts are placed at the point of purchase, however, consumers can use the nutritional infor­ mation and compare their options to make informed choices. currently, in cities and states with no menu labeling legislation, people do not receive the same nutritional information when they eat out as they do when they read labels on packaged food at the grocery store. 46 when nutrition information is labeled explicitly, consumers can compare options and make informed dietary decisions. ill. menu labeling legislation: an overview menu labeling legislation is not a new concept, but it has rapidly de­ veloped in recent years. in february 2003, maine became .the first state to introduce a menu labeling bill was introduced.47 subsequently, new york and texas passed legislation requiring ''the warning label 'eating fatty foods may lead to obesity' next to all menu items that [have] more than 44. see brief for professor robert post et al., as amici curaie supporting defendants at 10-11, california restaurant association v. the city and county of san francisco and the san francisco dep't of public health. no.cv-08-3247 cw (n.d. cal. july 31, 2008) [hereinafter "brief for professor robert postj; see 21 u.s.c. §343 (2000). 45. notice of adoption, supra note 9, at 6 (citations omitted) ("with nutrition informa­ tion, consumers are 24% to37% less likely to select high-calorie items" (citation omitted)). 46. center for science in the public interest, menu labeling bill clears key hurdle in california: health advocates urge passage in assembly, cspi newsroom (aug. 30, 2007), http://www.cspinet.org/new/200708301_printhtml [hereinafter "key hurdles"]. 47. center for consumer freedom, menu labeling legislation: an overview, nov. 12, 2003, http://www.consumerfreedom.com/news_detail.cfin?headline=2215 (last visited au­ gust 16, 2009). 314 indiana health law review [vol. 7:305 one-third of their calories from fat.'"'8 to date, only new york city, king county (seattle), washington state, philadelphia and california have enacted menu labeling legislation requiring nutrition information on menus and menu boards for chain restaurants. in 2007, twenty states and locali­ ties introduced menu labeling bills.49 currently, twenty-six states, washing­ ton d.c., puerto rico and numerous cities and counties around the country have proposed menu labeling legislation. 50 this legislative trend illustrates how quickly the idea is gaining popularity. a. new york city new york city was the first city to adopt menu labeling requirements when the new york city department of health and mental hygiene enacted new york city health code section 81.50 (regulation 81.50) on december 5, 2006.51 set to take effect on july 1, 2007, regulation 81.50 would have required new york city restaurants, already providing calorie content information about their menu items 52 to post such. information on restaurant menu boards and menus. 53 the purpose behind enacting regula­ tion 81.50 was to combat the obesity epidemic in new york city. 54 howev­ er, the new york state restaurant association (nysra), a not-for-profit business association of over 7,000 restaurants, challenged the regulation as invalid (nysra i). 55 the nysra argued that the nlea expressly preempts regulation 81.50. 56 the nysra also argued that regulation 81.50 is unconstitutional because the regulation violates the first amend­ ment. 57 a new york district court found that the city does have the power to mandate nutritional labeling by restaurants. the manner by which the city actually mandated was found to run afoul of the federal statutory scheme for voluntary nutritional claims since regulation 81.50 applies only 48. id 49. historic menu labeling poll, supra note 17. 50. national conference of state legislatures, trans fat and menu labeling legisla­ tion, www.ncsl.org/programslhealtb/transfatmenulabelingbills.htm (last visited jan. 3, 2009); see also ccpha menu labeling in chain restaurants, supra note 1 (providing a list of all cities, counties and state in which legislation is pending). 51. n.y. state rest. ass'n v. n.y. bd. of health, 509 f. supp. 2d 351, 353 (s.d.n.y. 2007) [hereinafter "nysra r1. 52. id (explaining that the regulation would apply to "standardized menu items 'for which calorie content information is made publicly available on or after march 1, 2007"'). 53. new york city, n.y., health code §81.50 (2006); nysra /, 509 f.supp.2d at 352 (''this regulation would affect roughly ten percent of restaurants in new york city, includ­ ing chain restaurants such as mcdonald's"). 54. nysra l 509 f.supp.2d at 353. 55. nysra l 509 f.supp.2d at 352 (this regulation would affect about ten percent of restaurants in new york city). 56. /d at 352; see also 21 u.s.c. §343. 57. nysra /, 509 f.supp.2d at 352-353. 2010] · combating obesity 315 to restaurants that already provide calorie information for its products.58 the court did not decide the first amendment claims. 59 after the judgment, the new york city department of health and mental hygiene reenacted a new section section 81.50 (revised 81.50) on january 22, 2008.60 revised 81.50 would have required all new york city restaurants with fifteen or more locations nationally to display calorie con­ tent on menus and menu boards.61 like the original regulation 81.50, re­ vised 81.50 was enacted for the advancement of public health by combating obesity. 62 nysra again sued the new york city board of health in the southern district of new york (''nysra 11").63 the nysra argued that, in direct contrast to the nysra i ruling, that laws and regulations requiring all restaurants of a certain class to disclose nutritional content information are subject to nlea preemption.64 nysra sought to enjoin the enforce­ ment of revised 81.50. new york city responded by filing a cross-motion for summary judgment on the preemption claim. the nysra ii court rei­ terated that nlea permits states and localities to require restaurants to dis­ close factual nutritional information about their food.65 the court upheld the reasoning behind nysra i, and concluded that the regulation was not preempted by nlea because new york city's revised regulation was per­ missible in its nutritional labeling requirements.66 the court granted new york city's summary judgment and nysra appealed.67 nysra sought a stay pending appeal, which the court of appeals of the second circuit de­ nied.68 the court held oral arguments on june 12, 2008, during which it heard from counsel for nysra, new york city, and the food and drug administration. 69 in the meantime, "[t]he new york city menu labeling regulations went into effect [on] march 31, 2008."70 the regulation requires establish­ ments with fifteen or more restaurants nationally, to list calories for stan­ dard menu items at the point of purchase.71 "font and format used for 58. !d. at 352-53. 59. id at 353. 60. new york city, n.y. health code §81.50 (2008). 61. id 62. n.y. state rest. ass'nv. n.y. bd. ofhealth, 545 f. supp.2d 363, 368 (s.d.n.y. 2008) [hereinafter "nysra ir']. 63. !d. 64. lainie rutkow et al., preemption and the obesity epidemic: state and local menu labeling laws and the nutrition labeling and education act, 36 j.l. med. & ennes 772, 786 (2008) (quoting brief for plaintiff at 17, n.y. state rest. ass'n v. n.y. citybd. of health (s.d.n.y. jan.31, 2008)). 65. nysra ii, 545 f. supp2d at 366. 66. id 67. id 68. n.y. state rest. ass'n v. n.y. bd. ofhealth, 556 f.3d 114, 122 (2d cir. 2009). 69. !d. 70. see ccpha nutrition labeling in chain restaurants, supra note 1, at 2. 71. !d. 316 indiana health law review [vol. 7:305 calorie information must be at least as prominent in size as is used for the name or price of the menu item. "72 · on appeal, the lower court's decision was affirmed, with the appellate court holding that: ( 1) new york city law was not preempted by the nlea; (2) rational basis was the appropriate standard for determining whether city law violated the first amendment's protection of commercial speech; and (3) new york city law was reasonably related to the city's goal ofreducing obesity.73 b. california local patchwork preempted by new state wide legislation besides new york city, california has been a leader in menu labeling legislation. before statewide menu labeling legislation was passed in octo­ ber 2008, numerous cities and counties in california either had passed menu labeling laws or had legislation pending. in san francisco city and county, food establishments with twenty or more units in california were required to post nutrition information on their menus and menu boards. nutrition information did not have to be dis­ played on menus for items placed on the counter for general use, such as condiments, alcoholic beverages and items that were on the menu for less than thirty days. chains were required to report their nutrition information to the department of health on an annual basis.74 in santa clara county, food establishments with fourteen or more units in california were required to post nutrition information on their me­ nus and menu boards. nutrition information did not have to be displayed on menus for "[i]tems placed at the counter for general use, alcoholic beve­ rages, and items that are on the menu for less than [thirty] days."75 although similar, the various local laws in california differed in such a way that res­ taurants could not comply with each local law simultaneously. not only did restaurants have to decide if the regulation even applied to them from city to city, but they also had to comply with minute details regarding what should be displayed, exceptions to the rules, and various reporting require­ ments. as a response to pressure from the restaurant industry to have a more uniform law in california, the california legislature introduced statewide legislation on january 22,2007. known as sb 120 and sponsored by sena­ tors alex padilla and carole midgen, the proposed bill made it successfully through both chambers of the legislature. 76 if passed, sb 120 would have applied to restaurants with fifteen or more chains nationally, standardized 72. /d. 73. new york state restaurant ass 'n, 556 f.3d at 135-36. 74. ccpha nutrition labeling in chain restaurants, supra note i, at 2. 75. /d. at3. 76. historic menu labeling bill, supra note 16, at i. 2010] combating obesity 317 menu items only, and would not have applied to daily specials or custo­ mized orders.77 further, sb 120 excluded menu items that were on the menu for less than six months, condiments, and other items placed on the table or counter for general use without charge and alcoholic beverages. 78 if a restaurant violated the requirements of sb 120, it will be found guilty of an infraction and fined from $50 to $500.79 nonetheless, the proposed bill was vetoed october 14,2007. almost a year later, on october 1, 2008, governor schwarzenegger signed sb 1420, california's statewide menu labeling bill, as part of an ef­ fort to address the state's growing obesity epidemic.80 as a result, califor­ nia has become a leader among states in passing menu labeling legislation. 81 s.b. 1420 was the first state law of its kind in the nation and won the sup­ port of the california restaurant association, because it standardized re­ quirements and preempted local ordinances in the cities of santa clara and san francisco.82 sb 1420 is an important measure in combating obesity in california due to the "estimated 15,000 fast food establishments" in the state, but also nearly sixty percent of californians are either overweight or obese. 83 this landmark legislation became a necessary response to the local patchwork of menu labeling laws across california that had made implementation very difficult for restaurants and caused confusion among customers. although sb 120 was not passed, sb 1420 successfully passed through the california legislature, and accomplished the ultimate goal of providing consumers with the nutrition information they need to make informed choices. 84 a public opinion poll conducted in 2007 demonstrates that eighty-four percent of californians backed the bill. 85 the statewide legislation goes into full effect on january 1, 2011,86 requiring restaurants with twenty or more loca­ tions in california to provide nutritional information in brochures.87 restau77. id. 78. s.b. 120bill analysis, supra note 24, at 4. 79. ld. at4 .. 80. california menu labeling law passes, oct. l, 2008 http://www.vpico.com/ artic­ lemanager/printerfriendly.aspx?article=211378 (last visited oct. i, 2008). 81. id. 82. jerry hirsch, stepping up to the plate for more food regulation, l.a. times, dec. 17,2008. 83. center for weight & health. supra note 11, at i. 84. rudd center for food poucy and 0bes11y, yale universlly, a case 81udy of california's menu labeling legislation (2008). 85. see goozner, supra note 2. 86. california center for public health advocacy, sb 1420 fact sheet, http://www.publichealthadvocacy.org/pdfs/sb1420factsheet.pdf (last visited aug. 16, 2009) [hereinafter "ccpha sb1420'']. 87. california first state to pass menu labeling law: chain restaurant menus must include calorie· counts, http://consumeraffairs.com/news04/2008/1 0/ca_ menu_labels.html (oct. 1, 2008) [hereinafter "california first statej; ccpha california leads nation, supra note 35 (explaining how sb 1420 provides for a two-year phase in period, but restaurants are 318 indiana heal til law review [vol. 7:305 rants are permitted to provide nutritional information prior to the effective date, and the legislature hopes "that some restaurants . will skip the first phase of implementation and go straight to posting calories on the menu in 2009. "88 the first implementation phase will take. place "[ f]rom july 1, 2009 to december 31, 2010 ·when restaurants must provide· a brochure placed at the point of purchase that includes" figures associated with calo­ ries, sodium, saturated fat and carbohydrates for each menu item. 89 al­ though these requirements apply to all restaurants, sit-down restaurants must provide the information at the table while drive-thrus must provide a notice of and give brochures to customers upon. request. 90 in the second implementation phase, restaurants must list calories on menus and menu boards next to each menu item by january 1, 2011.91 the bill also preempts cities and counties from enacting competing menu labeling provisions. 92 c. king county (seattle), washington in king county, washington, food establishments with fifteen or more national locations with one million dollars in annual sales must list nutrition information at the point of purchase. restaurants, however, do not need to list nutrition facts "for items on the menu for less than [ninety] days; un­ opened prepackaged foods; food in salad bars, buffet lines, cafeteria service and other self serve arrangements. 93 legislation enacted and proposed in new york city, california and washington demonstrate both similarities and differences in the fine details, and how the differences causing difficul­ ty for restaurants attempting to comply with such legislation. d. philadelphia the city of philadelphia recently amended its health code on october 23, 2008, by passing a menu labeling ordinance taking effect on january 1, 2010.94 the ordinance follows similar legislation in new york city, cali­ fornia, and elsewhere. because this legislation outlines requirements for more types of menu items and has fewer exemptions, however; it is one of the toughest menu labeling laws for restaurants to comply with in the coun­ try.95 the new ordinance applies to chain restaurants or retail food estabrequired to provide brochures containing nutritional information at·the pomt of sale begin­ ning july 1, 2009). 88. ccpha sb 1420 fact sheet, supra note 82. 89. /d. 90. /d. 91. /d. 92. see california first state, supra note 83. 93. see ccpha nutrition labeling in chain restaurants, supra note 1. 94. philadelphia, pa., liealtii code tit. 6, cb .. 6-100 (2008), available at http://webapps.phila.gov/council/attacbments/5823.pdf qast visited april 14, 20 l 0). 95, dale, supra note 26, at 12. 2010] combating obesity 319 lishments that conduct business under ''the same trade name as used by teen ... or more other establishments ... regardless of' whether those estab­ lishments are located in the city of philadelphia or elsewhere.96 restau­ restaurants are required to put "[t]he total number of calories ... , grams of saturated fat, grams of trans fat, grams of carbohydrates and milligrams of sodium ... adjacent to each item on the menu, in a size and typeface similar to [the] price."97 if a restaurant does not use menus, it only must include calorie information on the menu board while also including the words "ad­ ditional nutrition information for all menu items available upon request" in a clear and conspicuous typeface.98 restaurants may petition the philadel­ phia board of health if they want to vary the presentation method of the required information, but the required information must still be at the point of purchase and consistent with public health.99 e. indiana: pending legislation indiana's menu labeling legislation was introduced to the indiana house of representatives by representative charlie brown on january 16, 2008.100 "advocates point to the state's high obesity rate as one of the most compelling reasons to adopt the bill."101 indiana house bill 1361 "[r]equires a food establishment with ten or more locations in indiana to make certain nutritional information available to customers for each item or unit of food." 102 the bill also establishes civil penalties for violations, in which a penalty shall not exceed $1,000.103 the bill requires the following nutritional information to be made available to customers for each unit of food available for consumption: total calories, fat, saturated fat, trans fat, cholesterol, sodium, carbohydrates, fiber, sugar and protein.104 information required by the bill must be made available in a manner that allows con­ sumers to consider the information when selecting their food, including placement of the information on the menu board or on a separately printed 96. philadelphia, pa. health code tit. 6, ch. 6-100, §6-102(6.1). 97. philadelphia, pa. health code tit. 6, ch. 6-100, §6-308(l)(a);.see philadelphia, pa. health code tit. 6, ch. 6-100, §6-308(2) (restaurants must include the following statement on menus and menu boards: "a 2,000 calorie daily diet is used as the basis for general nutrition advice; individual calorie needs, however, may vary."). 98. philadelphia, pa. health code tit. 6, ch. 6-100, §6-308(1)(b) 99. philadelphia, pa. health code tit. 6, ch. 6-100, §6-308(1)(c). 100. h.b. 1361, ll5th gen. assem., 2d. reg. sess. (ind. 2008), available at www.in.gov/legislativelhouse _democrats/brown_ index.html (last visited july 22, 2009). 101. barb berggoetz, calories could be coming to your menu, the indianapolis star, feb.l3, 2009, at a1 (indiana's obesity rate is 27.5 percent which ranks 11th national­ ly). 102. h.b. 1361. 103. h.b. 1361, ch. 14.1, §4; see also office of fiscal & mgmt. analysis, fiscal impact statement: h.b. 1361 (the bill does not specify the enforcement authority but presumably it would be the indiana state department of health). 104. h.b. 1361, ch. 14.1, §2(1)-(10). 320 indiana health law review [vol. 7:305 document made available to consumers.105 if the required nutrition infor­ mation .is provided to consumers on a menu board of the restaurant, it must be in the same or similar font and format as the surrounding information regarding a particular food.106 if restaurant franchises offer the information n a separately printed document, it must be in a legible font and appro­ priately formatted for the type of document chosen.107 house bill 1361 was referred·to the indiana house committee on public health,108 and.passed fifty-one to forty-six on february 25,2009. the bill now moves to these­ nate, but its fate.in the senate is uncertain. state senator patricia miller, chairwoman of the senate health and providers services committee, said that she :is undecided as to whether she will "give the legislation a hearing because she. [is not] sold on the idea that [itis] the government's role to in­ terfere in such matters. "109 senator miller further mentioned the possibility of holding a hearing to make information surrounding the bill available to the public. 110 iv. argument for a national standard some restaurant organizations go further than demanding uniform state legislation and seek. uniform legislation at the national level. while the national council of chain restaurants (nccr) recognizes that califor­ nia's new statewide menu labeling legislation (sb, 1420) provides a state­ wide standard replacing a "confusing and inefficient hodgepodge of local california ordinances,"111 the nccr has expressed disappointment over sb 1420,m because it would like to see a "consistent, uniform, nationwide standard."! 13 nccr indicated that it takes issue with the current legislation becaus.e the law applies to only twenty percent of california restaurants.114 while a state standard is better than a patchwork of local standards within a state, a national standard would provide even more clarity, consistency and flexibility for restaurants. 115 105. h.b. 1361, cb. 14.1, §3(a). 106. h.b. 1361, ch. 14.1, §3(bx1) and (2). 107. h.b. 1361, cb. 14.1, §3(c). 108. session information-action list: house bill 1361, http://www.in.gov/apps/lsa/ sessionlbillwatchlbillinfo?year=2008&request=getactions&doctype=hb&docno==136 (last visited aug. 16, 2009). 109. see berggoetz, supra note 97. 110. i(/. 111. press release, chain leader, nccr disappointed by california menu labeling law (sept. 3q, 2008), available at http://www.chainleader.com/article/ca6600801.btml [hereinafter ''nccr press release"). 112. id. 113. id 114. id. 115. national restaurant association, public . policy .issue briefs: menu labe­ ling/nutrition information, jan. 17, 2009, bttp:/lwww.restaurant.org/government/issues/ issue.cfm?issue=menulabel (last visited aug. 16, 2009). 2010] combating obesity 321 many state and local menu labeling laws and proposed laws are simi­ lar; however, the differences ,are enough to make implementation difficult without a national standard for example, there are variations in the num­ ber of establishments required before the regulation applies. pending menu labeling legislation in chicago would apply to restaurants with fifteen or. more chains nationally.116 montgomery county, maryland's pending menu labeling law would apply to establishments ''with at least ten nationalloca­ tions."117 arizona's legislation would apply to establishments with "[ten] locations nationally and [five] or more locations" within the state of arizo­ na.118 some states like iowa, have pending legislation that only applies to establishments with "twenty or more locations statewide."119 other differ­ ences include how long restaurants have until implementation becomes mandatory, what type of nutritional information must be included, 120 when exemptions will be given for nonstandard and temporary food items, re­ quired physical font size of the information, and alternative ways informa­ tion can be displayed. one can see how burdensome it will become for restaurants to determine the applicability of these laws and how to comply with the different requirements. a national standard would assist with compliance among states. restaurants that will be subject to menu labeling legislation are not necessarily against providing nutrition information to their customers. in fact, restaurants recognize that people "are becoming more health con­ scious" and want customers to have access to detailed and consistent nutri­ tion information.121 with a national standard, consumers will receive a consistent set of detailed nutrition facts across the country. this is why many restaurant groups call for a national standard. the not-for-profit enti­ ty, center for science in the public interest (cspi) has spearh<:mded a na• tionwide menu labeling movement. 122 margo wootan, nutrition policy director of cspi, furthered her support of a nationwide mandate, stating, '"ten years from now, it will probably seem strange that once upon a time, chain restaurants didn't list calories on menus and menu boards for every­ one to see."123 not all restaurants are against menu labeling.124 kevin west116. see ccpha nutrition labeling in chain restaurants. supra note 1. at 3. 117. /d. at4. 118. /d. at 6. 119. /d. at 8. 120. see e.g., press release, national restaurant association, new coalition advocates national nutrition standard for chain restaurants (oct. 22, 2008), available at http://www.restaurant.org/pressroomlpressrelease.cfm?id= 1702 (''new york city requires just caloric information while seattle requires calories, sodium, saturated fat and carbohy­ drates be listed on their menu") [hereinafter "nra press release'l 121. /d. 122. center for consumer freedom, supra note 48. 123. california first state, supra note 83. 124. california center for public health advocacy, city of los angeles formally en­ dorses bill: coalition of health advocates optimistic governor will sign menu-labeling 322 indiana health law review [vol. 7:305 ley, executive director of the golden gate restaurant association, pointed out, however, that "[r]estaurants would prefer not to be regulated ... , but if this.is part of a larger program to fight childhood obesity, then [restaurants are] ready to do [their] part."125 nevertheless, it is important that proposed legislation address industry concern in order to obtain support and coopera­ tion from restaurants. many restaurants are in favor of more uniform stan­ dards at the state level as opposed to numerous local laws differing in requirements. a. the labeling education and nutrition act o/2008-proposed national measure in september 2008, the labeling education and nutrition act of 2008 (lean act) was introduced in the house by representative jim matheson and in the senate by senators tom carper and lisa murkowski.126 the lean act will build upon nlea, which requires uniform labels for nutri­ tion information on packaged foods and beverages, to include mandatory listing of nutritional information for food sold in chain restaurants in all fifty states. the lean act would establish a uniform national nutrition labeling standard for chain restaurants by "provid[ing] for a single set of guidelines in how nutrition information is calculated,"127 and bestowing legal protection on law-abiding restaurants. 128 the lean act would apply only to chains with twenty or more establishments under the same trade name re&ardless of ownership.129 in sum, the act only applies to larger chain restaurants better suited to meet the act's requirements since typically they already have standard menus and standard preparation methods in place. b. the coalition for responsible nutrition information (crni) when congress introduced the lean act, the crni was formed to promote the expansion of flexible federallegislation.130 the crni wants to bill, sacramento, ca (sept. 25, 2007), available at http://www.coavision.org/media/ press _releases/sb%20 120%20advocates%200ptimistico/o20release _final.pdf. 125. /d. 126. see national restaurant association, supra note 111; the coalition for responsi­ ble nutrition information, lean act senate, http://www.nationalnutritionstandards.com/ senatelegislation.html (last viewed jan. 17, 2009) (the senate version of the lean act (s. 3575) was introduced on september 25, 2008 by senator tom carper of delaware and sena­ tor lisa murkowski of alaska. the bill was referred to the senate committee on health, education, labor and pensions). 127. crni faqs, supra note 40. 128. see national restaurant association, supra note 111. 129. labeling education and nutrition act of2008, s. 3575, 110th cong., §6(8) (2008). 130. see national restaurant association, supra note 111. ("the coalition has more than thirty companies and associations" as members, led by the national restaurant associa­ tion). 2010] combating obesity 323 ensure that fast food customers receive detailed written nutrition infqrma­ tion in a consistent and convenient manner by creating a ul:tiform, national standard.131 the crni also supports expanding nlea to include more de­ tailed nutritional information than just calories for food sold nationwide·by major chain restaurants.132 the lean act provides a compromise between restaurants trying to comply with mandatory nutrition labeling, and customers who would bene­ fit from nutrition information at the point of purchase. the act requires calorie information to be on the menu or menu board at restaurants.133 the act is less stringent, however, with regard to the display of nutritional in­ formation, as long as the required information is available to the customer in writing somewhere in the restaurant before the point of purchase.134 the lean act still mandates a referral statement at the point of purchase that directs the consumer to the availability of additional nutrition information required under the act, 135 but restaurants are given some flexibility and customers still receive important information. while a restaurant could provide nutrition information on the main menu, it could also resort to other less effective means such as tray liners, kiosks and brochures, if customers are directed to the information explicitly by the referral statement. the crni supports national legislation which allows restaurants some flexibili­ ty in posting or providing nutritional information in a consistent manner and according to customer preferences.136 local governments are not able to regulation nutrition information la­ bels on packaged foods, as these national standards are provided by nlea. accordingly, the individual cities, counties, and states should not be able to set different nutritional information requirements for food served in restau­ rants. the crni argues for nationwide uniformity in menu labeling re­ quirements: consumers deserve to have convenient access to the same detailed nutrition information. that they now find on packaged foods in their grocery store ... the more nutrition information consumers have at their dispos­ al, the better decisions they are able to make for their individual dietary needs and those of their families.137 131. see nra press release, supra note 116. 132. see crni faqs, supra note 40. 133. see e.g., s. 3575, §6(8xa) (providing requirements for what information must be displayed on a menu board and where and what information must be provided if the informa­ tion is not displayed on a menu board 134. s. 3575, §6(8)(b). 135. s. 3575, §6(8xc). 136. crni faqs, supra note 40. 137. id. 324 indiana health law review [vol. 7:305 v. argument for a uniform standard at the state level in the absence of federal legislation. states should consider statewide legislation as an alternative to varying and inconsistent local laws. califor­ nia was the first state to pass statewide legislation for menu labeling. the california restaurant association (cra) had urged state legislators to create "a uniform statewide standard for nutritional information disclosure: " 138 as jot condie, president of the cra pointed out, stated, '"a pat­ chwork of differing local ordinances such as those in santa clara and san francisco would be challenging for restaurants to meet and confusing for their customers ... a flexible statewide approach to nutritional information disclosure would serve the best interests of both restaurants and their con­ sumers. "'139 california governor schwarzenegger agreed, stating that "'[i]nflexible mandates applied sporadically are not an effective way to con­ tinue our progress in educating californians about healthy living. "'140 a. the nlea does not regulate nutrition information labeling on res­ taurant food, and states and localities are free to adopt their own rules federal law does not preempt state and local governments from adopt­ ing their own menu labeling laws. the united states court of appeals for the second circuit has provided the only existing case law interpreting state ' and local menu labeling laws and federal preemption to date. according to the second circuit, congress intended to exempt restaurant food from the preemption sections required for the sale of food interstate. 141 the court stated that, in requiring chain restaurants to post calorie information on their menus, ''new york city merely stepped into a sphere that congress inten­ tionally left open to state and local govemments."142 the court concluded that the scheme of nlea is simple when it comes to restaurant food­ nlea does not regulate nutrition information labeling on restaurant food, and, therefore, states and localities are free to adopt their own rules. 143 nlea, however, generally regulates nutrition content claims on restaurant foods, and states and localities may only adopt rules that are identical to those provided in nlea.144 for example, the nlea does not preempt new york city from adopting its own requirements for nutrition labeling, 145 but 138. press release, california restaurant association, cra files second menu labe­ ling lawsuit, (july 23, 2008), available at http://www.calrest.org/go/cra/news-events/news/ press-releases/era-files-second-menu-labeling-lawsuit/ (last visited oct. 2, 2008). 139. /d. 140. s.b. 120bill analysis, supra note 24, at 7. 141. n.y. state rest. ass'n, 556 f.3d at 118. 142. /d. 143. /d. 144. /d. 145. see 21 u.s.c. § 343-l(a)(4). 2010] combatlng obesity 325 it does generally preempt it from adopting different rules for nutrient con­ tent claims.146 vi. policy in favor of menu labeling legislation the obesity epidemic in the united states has grown at a rate similar to that of consumption of restaurant foods over the past several decades, signaling that regulation is necessary. reversing the epidemic will require a broad range of solutions operating at multiple governmental levels and involving multiple segments of society. menu labeling at fast food restau­ rants is but one solution to combat obesity. menu labeling by itself will not cure the obesity epidemic, but it provides a start. obesity does not just adversely affect the obese individual, but places an extensive economic burden on the whole nation when health care costs and lost productivity are considered. "between 1987 and 2001, the rising rate of obesity and related medical conditions accounted for more than one­ quarter of the growth in heath care spending in the united states."147 fur­ ther, the costs associated with lost productivity "attributable to obesity have been estimated to be even greater than health care costs."148 the obesity-related health concerns of the american people warrant additional legislation in this area despite the opposition from members of the restaurant industry. 149 the intention of such laws is not to ban fast food, but rather to encourage customers to consider their choices more carefully in light of additional nutritional information. although restaurants may oppose adoption of menu labeling legislation, restaurants are already sub­ ject to laws "requiring them to pay a higher minimum wage, post health inspection grades and prohibit smoking-all of which they vigorously op­ posed."150 thus, restaurant chains will survive and adapt to the new re­ quirements as they have done for past requirements to which they had initially opposed.151 menu labeling legislation does not have a purpose of deterring people from eating fast food entirely. people will still eat fast food, but they will be able to make informed decisions when they do so. nutrition information 146. see id. at 343-l(a)(s). 147. simonet al, supra note 5, at 2. 148. id.; brief for professor robert post, supra note 45, at 8. ("the san francisco de­ partment of public health estimates that the obesity epidemic costs san francisco $192 mil­ lion per year in medical expenses, lost productivity and worker's compensation" (citation omitted)). 149. harold goldstein & eric schlosser, putting health on the menu: requiring fast food and restaurant chains to post calorie information wouldn't hurt them and could help us, l.a. times, aug. 5, 2008, available at http://www.iatimes.com/news/printedition/ opinionlla-oe-schlosser5-2008aug05,0, l626001.story (last visited aprill4, 2010). 150. id. 151. id. 326 indiana health law revffiw [vol. 7:305 at the point of purchase will "give consumers the option to choose items on the menu that meet their nutritional needs. "152 more informed decisions would alter consumption habits and, in tum, alter the demand for unhealthy products, causing restaurant franchises to change their menus to healthier selections. instead of going out of business, restaurants will merely have an incentive to reformulate their products to reduce calories and add healthier options to their menu. based on experiences with the nutrition labeling act for packaged foods, and recent legislation to include trans fatty acids on labels,. companies were shown to be able to change formulation·in ways that promote health and also maintain product appeal.153 possible reformula­ tions include changing ingredients, changing cooking methods, and reduc­ ing portion sizes of menu items. 154 vii. policy arguments against menu labeling legislation where should government regulation end and personal responsibility for one's own health begin? opponents of menu labeling laws, such as the national restaurant association, view such legislation as governmental exercise of the parens patriae doctrine, arguing that the government is overreaching is powers to result people's lives and health when it acts of "food police. " 155 furthermore, advocacy groups, such as the california al­ liance for consumer protection, agree with the intent of menu labeling laws, but believe that such laws are not restrictive enough, especially when a patchwork of local laws within a state do not apply to every restaurant in the state.156 restaurants argue that implementation of menu labeling requirements is difficult, costly and impractical. although most menu labeling laws only apply to larger restaurants with standardized menu items, "[m]andatory labeling of restaurant foods could potentially lead to significant economic costs for the restaurant industry, especially in calculating and displaying information."157 for a restaurant whose menu has 100 items, it is estimated that the restaurant will spend $22,000 to determine the nutrition informa­ tion.158 further, it may cost a restaurant as much as $25,000 for n:ew restau152. yale university rudd center for food policy and obesity, menu labeling laws, http://yaleruddcenter.org/what_ we_ do.aspx?id= 124 (last visited august 16, 2009). 153. simonet al., supra note 5, at 5. 154. ld. 155. jerry hirsch, stepping up to the plate for more food regulation, l.a.times, dec. 17,2008. 156. s.b. 120bn.lanalysis, supra note 24, at 6. 157. rebecca s. fribush, putting calorie and fat counts on the table: should man­ datory nutritional disclosure laws apply to restaurant foods?, 73 geo. wash. l. rev. 377, 386 (2005). 158. id. 2010] combating obesity 327 rant menus,159 which must be reprinted every time the menu changes. in addition to the extreme costs in implementing these measures, many food items that are similar in size may differ greatly in nutritional value. lastly, "restaurant portions are almost impossible to standardize."160 the california restaurant association (cra) argues that menu labe­ ling may discourage "creativity in the kitchen, especially in fine dining es­ tablishments."161 however, the law will only affect chain restaurants that are not fine dining establishments. in vetoing sb 120, governor schwarze­ negger stated that the bill "would place burdens and costs upon some res­ taurant owners while imposing no burdens or costs on others. " 162 he further stated that the bill does not allow much flexibility in how restaurants give nutritional information to their customers.163 finding ways to adapt these pre-existing methods to a more readily available format at the point of sale is not the problem. the problem lies in having to spend considerable time and money to incorporate this informa­ tion on their already congested menu boards, and in the possibility of slow­ ing consumer traffic down. fast food will no longer be fast. most of the chain restaurants affected, however, are willing to make nutritional data available, and, in fact, already provide nutritional information on the inter­ net and posters, and in brochures and kiosks. viii. possible constitutional challenge to menu labeling legislation-infringement of commercial speech a federal law requiring restaurants to disclose nutrition information on their menus and menu boards could potentially be challenged on first amendment grounds if mandatory disclosure is found to infringe on a res­ taurant's commercial speech. it is undisputed that commercial speech is entitled to first amendment protection. 164 mandatory menu labeling laws deal with commercial speech, which is defined as speech that proposes a commercial transaction, here the sale of a restaurant meal. while the first amendment guarantees protection of both commercial and noncommercial speech, 165 "less protection is [afforded] to commercial speech than other 159. id. at 387. 160. center for consumer freedom, supra note 48 ("[i]magine trying to ensure that each steak is cut to the exact same size and that each order of stir fried vegetables uses the exact same amount of oil. a generous chef could trigger the arrival of unscrupulous and opportunistic lawyers."). 161. s.b. 120 bill analysis at 6, january 8, 2008, available at http://info.sen.ca.gov/pub/0708/bill/sen!sb _ 01010 150/sb _120 _ cfa_ 20080108 _154841_sen_ fl oor.html. 162. !d. at 6. 163. id. 164. zauderer v. office of disciplinary counsel, 471 u.s. 626, 637, (1985). 165. see virginia pharmacy board v. virginia citizens consumer council, 425 u.s. 748 (1976). 328 indiana heal til law review [vol. 7:305 forms of expression.: 166 even within the class of regulations affecting com­ mercial speech, varying levels of protection are given to the speech depend­ ing· on .the type of commercial speech at issue. the supreme court has stated that there· are material differences between purely factual and uncon­ troversial disclosure requirements and outright prohibitions on speech167 regulations that compel purely factual and uncontroversial commercial speech are subject to more lenient review than regulations that restrict accu­ rate commercial speech.168 the second circuit court of appeals explained: mandated disclosure of accurate, factual, and uncon­ troversial commercial information does not offend the core first amendment values of promoting efficient exchange of information or protecting individual li­ berty interests. such disclosure furthers, rather than hinders, the first amendment goal of discovery of truth and contributes to the efficiency of the "market­ place of ideas." protection ofthe robust and free flow of accurate information is the principal first amend­ ment justification for protecting commercial speech, and requiring disclosure of truthful information pro­ motes that goal. in such a case, then, less exacting scrutiny is requirement than where truthful, non­ misleading commercial speech is restricted.169 although first amendment speech rights are implicated by menu labeling requirements, such regulations are given less scrutiny than normal speech and do not violate the constitution under certain circumstances. a. central hudson gas & electric corp. v. public service commission. the united states supreme court has explicitly stated that a commer­ cial speaker's constitutionally protected interest in not providing any partic­ ular factual information is minimal.170 regulations compelling commercial speech may be upheld. the supreme court uses a reasonable relationship test to uphold purely factual information as constitutional if such speech is reasonably related to an appropriate state interest.171 this test was set out in 166. pomeranz & brownell, supra note 41, at 1581. 167. zauderer, 471 u.s. at 650. 168. id at 651. 169. national electric manufacturers ass'n v. sorrell et al., 272 f.3d 104, 114 (2d cir. 2001). 170. zauderer, 411 u.s. at.651. 171. pomeranz & brownell, supra note 41, at 1581. (citing zauderer, 471 u.s. at 651). 2010] combating obesity 329 detail by the united states supreme court in central hudson gas & elec­ tric corp v. public service commission in 1980 (central hudson four part test).172 under the central hudson four part test, in order for a regulation compelling commercial speech to be upheld, ''a court must look at whether: (1) the expression concerns lawful activity and is not misleading; (2) the government's interest is substantial; (3) the restriction directly serves the asserted interest; and (4) the restriction is no more extensive than neces­ sary."t73 under this test, "[s]ome labeling requirements have been found to in­ fringe on a food purveyor's right to commercial speech,"174 but courts have still left open the possibility that public health might be a substantial inter­ est to permit compelled food labeling.175 for example, the second circuit court of appeals has recently held that new york city plainly demon­ strates a reasonable relationship between the purposes of its disclosure re­ quirements and the means employed to rectify the cited problem at hand: what the city termed an "obesity epidemic" .176 1. nutrition disclosure concerns lawful activity and is noi misleading mandatory disclosure of factual information "is a routine regulatory mechanism in the commercial marketplace," and the government has the power to require sellers of products to disclose factual information about their goods.177 menu labeling laws are another form of mandated factual disclosure. "a menu-labeling law compels the disclosure of factual infor­ mation (a calorie is a unit of measure for energy obtained from food and beverage) and not a subjective viewpoint (e.g., fried food is bad). 178 2. the government's interest in public health is substantial most, if not all, menu labeling legislation is proposed to address pub­ lic health issues. "between health-care costs and lost productivity, the con172. central hudson gas & electric corp. v. pub. serv. comm'n, 447 u.s. 557, 566 (1980). 173. fribush, supra note 154, at 388 (citing central hudson gas & electric corp., 447 u.s. at 566). 174. /d. ("[i]n internatronal dairy foods ass 'n. v. amestoy, the united states court of appeals for the second district found that a state law requiring identification of dairy prod­ uct from cows treated with certain hormones violated producers' first amendment rights to hold back information ... [t]he [court] found that the state's asserted interests [of] consumer interest, and the right to know[,] were not substantial enough to justify the regulation" int'l dairy, 92 f .3d (2d cir. 1996)). 175. fribush, supra note 154, at 388 (citing /nt'l dairy foods ass 'n, 92 f.3d at 73). 176. n.y. state rest. ass'n, 556 f.3d at 134. 177. pomeranz & brownell, supra note 41, at 1581 (providing examples of federal laws regulating labels of products in other facets. such as textile products and prescription drugs). 178. /d. 330 indlana health law review [vol. 7:305 sequences of obesity are in the billions and billions of dollars ... with menu labeling, we can begin to tum the comer on the (obesity) epidemic," said california senator alex padilla, sponsor of the menu labeling legislation in his state.179 further, in upholding new york city's regulation, the second circuit court of appeals found that new york city's interest in public health was substantial, 180 recognizing studies presented by new york city to support its claim that public health was a substantial interest. the studies supported the court's findings that obesity is a contributing factor for heart disease, diabetes, stroke, and cancer, which cased seventy percent of deaths in new york city in 2005.181 further, the court found that the obesity epidemic is mainly due to excess calorie consumption, often resulting from meals eaten away from the home182 lastly, the court found that chain restaurants serve food that is associated with excess calorie consumption and weight gain.183 new york city is not alone in claiming that public health is a substan­ tial interest. in support of its conclusion that public health is a substantial interest for new york city, the second circuit court of appeals discussed various other relevant studies: a 2006 fda-commissioned report concluded that "obesity has become a public health crisis of epidemic proportions." in addition, a 2005 study by the center for disease control and prevention (the "cdc") es­ timated that approximately 112,000 deaths in 2000 were associated with obesity in the united states. another study concluded that rising obesity rates led to increasing diabetes rates, finding that as of 2005, 15.8 million americans had diabetes, almost triple the number from 1980. yet another study concluded that with these increased rates of obesity and associated health problems, have come increased health costs. 184 to survive a free speech challenge, legislators should set out the gov­ ernment's public health objectives to show that the legislation rationally relates to the government's interest. it is arguable that menu labeling legis­ lation rationally relates to the government's interest in the promotion of informed decision making and the reduction and prevention of obesity.185 179. berggoetz, supra note 97. 180. n.y. state rest. ass'n, 556 f.3d 114 at 134. 181. see notice of adoption, supra note 9, at 3. 182. id. at 4-5 183. id. at 5. 184. new york state restaurant association, 556 f.3d at 136 (citations omitted). 185. pomeranz & brownell, supra note 41, at 1580. 2010] combating obesity 331 public health would likely be permissible as a substantial government inter­ est because not only have courts previously recognized public health as a substantial interest for the purpose of commercial speech regulation, 186 but there is also substantial convincing evidence out there to support the link between eating at chain restaurants and health risks such as obesity. 187 3. the restriction directly serves the asserted interest under the central hudson four part test, the government must also show that any proposed menu labeling legislation directly relates to promot­ ing public health. according to the rudd center for food policy and obes­ ity at yale university, "[c]onsuming fast-food is positively associated with weight gain, insulin resistance and increased risk for obesity and type two diabetes."188 one study found that each meal at a fast food establishment often contains more calories than a person should eat in an entire day and most fast food consumers eat fast food an average oftwo times per week. 189 eating an excess of calories two times per week causes the fast food con­ sumer to pack on the pounds and increases the risk of health issues asso­ ciated with being overweight or obese. 190 americans currently spend forty­ eight percent of their food dollars on· food prepared away from the home, and food prepared outside the home constitutes thirty-four percent of amer­ icans' daily caloric intake.191 therefore, by regulating fast food and chain restaurants, the government directly addresses a major cause of health is­ sues. the advancement of public health and obesity reduction is served by consumer disclosure requirements increasing the accuracy of factual infor­ mation available to consumers. 4. the restriction is not more extensive than necessary to meet the last prong of the central hudson four part test, the gov186. fribush, supra note 154, at388. 187. !d. 188. brief for jennifer l. pomeranz and kelly d. brownell of the rudd center for food policy and obesity at yale university as amicus curiae supporting defendants at 3, new york state restaurant association v. new york city board of health, 509 f .supp.2d 351 (s.d.n.y. 2007) (no. 08 ci. 100) (feb. 8, 2008). 189. id 190. see roberta r. friedman, rudd center for food poucy & obesity, menu labeling in chain restaurants: opportunities for public policy 3 ( 2008), available at http://www. yaleruddcenter.org/resources/uploadldocs/what/reports/ ruddmenulabelin­ greport2008.pdf (a health impact assessment done in los angeles county, california sug­ gests that menu labeling will help combat the obesity epidemic. if menu labeling helped ten percent of chain restaurant patrons reduce their average meal by i 00 calories, it could pre­ vent close to forty percent ofthe average annual6.75 million pound weight gain in the coun­ ty population). 191. n.y. state rest. ass'n., 556 f.3d at 135 (2d cir. (n.y.), 2009) {discussing the keystone report, a 2006 fda-commissioned report at 30, 122). 332 indiana healtif law review [vol. 7:305 emment must show that menu labeling is no more extensive than necessary and that nutrition information on menus. is most relevant to obesity preven­ tion. it could be argued that menu labeling is more extensive than neces­ sary in addressing public health because all restaurants could publish nutrition information for their customers in other ways besides directly on the menu. ~oviding calorie information, however, similar to that provided in nlea's nutrition fact panel, at the point of purchase would help con­ sumers make more informed, healthier choices.192 in addition, putting nutri­ tion information at the point of purchase has proven to be one of the most effective means of helping consumers make more informed decisions and healthier choices. studies have shown that alternative means of disclosure are not insufficient, and customers tend to miss seeing the nutrition infor­ mation. 193 ordering at restaurants is one of the few places where, with a simple, split-second decision, people can cut hundreds, even thousands, of calories. the link between obesity and eating outside the home suggests that information at point of purchase helps customers order healthier op­ tions, and a disclosure regulation is not too extensive to serve asserted health interests. ix. conclusion mandatory nutrition labels on fast food and chain restaurant menus and menu boards is an idea that is quickly catching on. while only a few major cities and one state have passed menu labeling legislation, cities, counties, and states across the country have proposed similar legislation in the last couple of years. the idea is catching on, and in the near future, it is likely to be common to see nutrition imormation on fast food menus. lead­ ing health authorities and national organizations including aarp, ameri­ can cancer society, american diabetes association, american medical association, institute of medicine, society for nutrition education and the united states food and drug administration's obesity working group all recommend addressing the lack of calorie information in restaurants. 194 a single national standard or, at a minimum, various state-wide stan­ dards, would not be difficult to implement and can solve an exponentially growing epidemic. mandating the display of calorie information by fast food and chain restaurants is feasible, will reach many consumers, and can be reasonably expected to have an overall positive health impact. our country is relatively unhealthy and the obesity epidemic is getting worse each year. since so many people eat fast food, menu labeling legislation will have an effect on a lot of meals. further, menu labeling legislation 192. see notice of adoption, supra note 9, at 6. 193. see id. at 7-8. 194. friedman, supra note 187, at 9. 2010] combating obesity 333 primarily affects large chain restaurants that have the resources to post· nu­ trition information about standardized menu items at the point of purchase. regulation of fast food is an important part of an integrated public response to the epidemic of obesity. it will not end obesity all by itself, but it is a decent place to start. menu labeling legislation also would not dictate what restaurants can serve or what people should eat but rather simply provides diners with the nutritional information they need to make healthier food decisions. in the absence of a national standard, states should strongly consider statewide legislation as an alternative to the current variety of local laws. while a state standard is better than a patchwork of local standards within a state, a national standard would provide greater clarity, consistency and flexibility for restaurants. california's recent passage of statewide legisla­ tion will hopefully prompt other states to follow its lead and similarly pass statewide legislation. statewide legislation is not as favored by restaurant associations because it will not only provide a nationally consistent law, but it is better than local patchwork of laws in the meantime. nevertheless, it will become quite burdensome for restaurants to figure out whether they fall under these laws and then determine how to comply with the different re­ quirements. a national standard would provide uniform requirements to comply with instead of setting different standards from state to state. with a national standard, consumers will receive a consistent set of detailed nutri­ tion facts across the country. consumers deserve to have convenient access to the same detailed nu­ trition information that they now find on packaged foods in the grocery store. menu labeling legislation is not meant to deter people from eating fast food. people will still eat fast food, but they will be able to make in­ formed decisions. nutrition information at the point of purchase will give consumers the option to choose items on the menu that meet their nutrition­ al needs. where's the beef an examination of the pink slime controversy and the implications of the real beef act on state truth-in-menu laws where's the beef? an examination of the "pink slime" controversy and the implications of the real beef act on state truth-in-menu laws crystal t. williams, esq.1 i. introduction ................................ ...... 474 ii. what is lftb (commonly referred to as "pink slime")? .......................................... 474 iii. the controversy ........................... 477 iv. legislative history and the proposed real beef act .................................... .......... 479 a. ingredients vs. processing aids .................. 480 b. lftb is considered a processing aid under current fda regulations ........................... ...... 482 c. fmia & the real beef act .................... 483 v. implications of the real beef act on the restaurant industry. .......................... 483 a. the real beef act does not apply to restaurants.. 484 b. the real beef act applies to restaurants ... .... 486 vi. jurisdictional issues posed by state truth-in-menu regulations ............................ ...... 488 a. california .............................. ....... 489 b. hawaii, illinois, and south dakota........ ........... 490 c. minnesota ............................. ....... 490 d. rhode island and new jersey. ................... 491 vii. conclusion ............................. ..... 492 1 crystal t. williams is an associate attorney at barnes & thornburg, llp, in indianapolis, indiana. williams concentrates her practice in general litigation, with a focus of food law. williams has experience advising clients in food labeling disputes (e.g. health, nutrient content and structure/function claims, allergens, nutrition facts, and menu labeling) and food advertising strategy (e.g. weight management, advertisements geared toward children, competitive advertisements). williams also has experience advising clients in the food truck industry (as well as restaurants and food servicers looking to get into the food truck industry) to help them navigate the applicable local and city-specific ordinances that govern food truck dimensions, construction, licenses, permitting, food preparation, and parking. indiana health law review i. introduction recent criticism concerning the use of lean finely textured beef ("lftb"), commonly referred to as "pink slime," has sparked a national debate about whether lftb should be included on the label of ground beef products sold to the end consumers. on march 30, 2012, the requiring easy and accurate labeling beef act (the "real beef act") was introduced to congress. 2 if passed, the real beef act would require that "labels on packages of meat include a statement on whether the meat contains [lftb ."3 the express language of the real beef act and its legislative history are not clear on whether the disclosure will be required for restaurants. this article is timely and relevant to the restaurant industry because it addresses the impact the real beef act may have on restaurant menu labeling. further, given the disclosure requirements of state truth-in-menu laws, an examination into how the real beef act will be applied on a state level is critical. first, this article explains the history of lftb, including how the substance is made and the impact it has on ground beef production. second, this article will discuss the current controversy concerning the use of lftb in ground beef products. third, this article will discuss the current law on food labeling and how the real beef act will change current legislation. fourth, this article will analyze the impact the real beef act may have on the restaurant industry. finally, this article will discuss the interplay between the real beef act and state truth-in-menu laws. ii. what is lftb (covvionly referred to as "pink slime")? today, "[g]round beef is the most popularly consumed beef product among american consumers" 4 and accounts for 2 requiring easy and accurate labeling beef act, h.r. 4346, 112th cong. § 2(d) (2012). 3 id. 4 joel l. greene, cong. research serv., r42473, lean finely textured beef: the "pink slime" controversy 1 (2012), available at http://www.fas.org/sgp/crs/misclr42473.pdf. 474 vol. 10:2 "pink slime" and ti e real beef act almost 45% of all beef consumed in the united states.5 ground beef is federally regulated and consists of chopped fresh and/or frozen beef with or without seasoning, with no more than 30% fat, and with no added water, phosphates, binders, or extenders. 6 "ground beef is produced from any part of the boneless beef carcass, but usually beef trimmings, which are a mixture of fat and meat that are trimmed from larger beef cuts."7 in fact, approximately 25% of a beef carcass is lean-beef trimmings.8 given consumers' high beef consumption, the recent controversy concerning lftb has had a profound effect on the beef industry.9 according to the united states department of agriculture ("usda"), lftb is a meat product derived from ground beef.10 beef products, inc. ("bpi") is the world's leading producer of lean beef from fresh beef trimmings, and in 1991, the company developed a process that increases the amount of lean meat that can be obtained from livestock carcasses. 11 the company purchases beef trimmings from usda inspected beef plants and sends the trimmings through a centrifuge process that separates the fat from the lean meat. 12 after the centrifuge process, the company uses ammonium hydroxide ("ammonia") to help 5 national cattelman's beef association, average annual per capita consumption beef cuts and ground beef beefusa.org, http:// www.beefusa.org/cmdoes/beefusa/resources/statistics/averageannual percapitaconsumptionbeefcutsandgroundbeef559.pdf (last visited apr. 07, 2013). 6 9 c.f.r. § 319.15(a) (2013). 7 greene, supra note 3. 8 id. at 2. 9 richard l. frank & robert a. hahn, the 'pink slime affair should lean finely textured beef be labeled., 2 food and drug pol'y f., may 2012, at 3 (noting that lftb is normally found in ground beef, but it is also combined with other beef components such as lunchmeats, sausage products and canned meats). 10 usda announces additional choices for beef products in the upcoming school year, usda.gov (march 15, 2012), http://www.usda. gov/wps/portallusda/usdahome?contentidonly=true&contentid=2012/03/ 0094.xml. 11 about bpi, beef products inc., http://www.beefproducts.com/ history.php (last visited apr. 07, 2013). 12 greene, supra note 3, at 2. 4752013 indiana health law review eliminate harmful bacteria such as e. coi and salmonella.1 3 ammonia, a compound that results from combining water, hydrogen, and nitrogen, is naturally found in the environment (i.e. air, water, and soil), plants and animals, and humans. 14 the compound is used extensively for food processing and can be found in baked goods, cheese, chocolate, and pudding.15 also known as "ph enhancement," treating the meat with ammonia raises the ph level in ground beef, which results in higher levels of ammonia. 16 ground beef that does not include lftb naturally contains approximately 100-150 parts per million ("ppm") of ammonia; however lftb, contains between 400-500 ppm of ammonia.17 furthermore, ph enhancement makes lftb approximately one hundred times more alkaline than untreated beef.18 after ph enhancement, the lftb mixture is flash frozen, pressed, combined with ground beef trimmings, and finally packaged and sold to grocery stores and restaurants. 19 bpi estimates that lftb "has been served in over 300 billion meals. 20 until recently, lftb was a popular product and widely used by restaurants, supermarket chains, and even the national school lunch program.21 in march 2012, 13 id. (ammonia hydroxide is created when the ammonia gas mixes with the water in the meat.). 14 questions and answers about ammonium hydroxide use in food production, foodinsight.org, (dec. 30, 2009), http://www.food insight.org/resources/detail.aspx?topic=questions and answers-about _ammoniumhydroxideuseinfoodproduction. 15 id 16 ammonium hydroxide, beef products, inc., http://beef products.com/ammoniumhydroxide.php (last visited apr. 07, 2013). 17 helena bottemiller, slimegate: should usda require labeling for lftb, food safety news, (apr. 03, 2012), http://www.foodsafety news.com/2012/04/slimegate-should-usda-require-labeling-for-lftb/. 18 id. 19 greene, supra note 3, at 2. 20 bpi lean finely textured beef what it's good in, beef products, inc., http://beefproducts.com/what-its-good-in.php (last visited apr. 7, 2013). 21 helena bottemiller, fast food companies abandon ammoniated beef food safety news (jan. 06, 2012), http://www.food safetynews.com/20 12/0 1/fast-food-companies-abandon-ammoniated-bee. 476 vol. 10:2 "pink slime" and the real bee i act critics of lftb spoke out about the possible dangers of lftb, claiming that it is unsafe for consumption, and arguing that food labels should inform consumers that the ground beef products they purchase contain lftb. ii. the controversy lftb supporters argue that lftb is leaner than trimmings produced through more conventional processes used to separate meat from fat such as a simple hand knife technique. as a result, the beef industry can "recover lean meat that would otherwise be wasted."22 lftb is normally added to ground beef and makes up 10-20% of ground beef, increasing the "leanness of the meat products."23 moreover, some argue that "lftb reduces the fat content of ground beef products, because lftb is 90 percent or higher lean."2 4 provided lftb makes ground beef products leaner, lftb gives consumers a leaner, healthier meat. furthermore, food and safety advocates point out that lftb is approved by the usda.25 in fact, the fda labels the compound as a "generally recognized as safe" ("gras") substance. 26 in a recent news release, the usda appeared to agree with the fda and the use of lftb, stating "the usda continues to affirm the safety of [lftb] product for all consumers and urges customers to consult science based information on the safety and quality of [the] product."27 still, critics point to the high levels of ammonia and alkaline present in lftb in contrast to untreated ground beef. critics also refute the claim that high levels of 22 lean finely textured beef fact sheet, (mar. 28, 2012), http:/ www.kipnews.org/wp-content/uploads/2012/04/lean-finely-texturedbeef-factsheet 1 .pdf. 23 greene, supra note 3, at 3. 24 frank & hahn, supra note 8, at 3. 25 id. at 2. 26 greene, supra note 3, at 3; see also 21 c.f.r. § 170.30 (2013) (noting that a substance qualifies as gras if it is generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as safe for its intended use). 27 usda announces additional choices for beef products in the upcoming school year, supra note 9. 2013 477 indiana health law review ammonia are good for ground beef products because they help kill deadly bacteria.28 they argue that because only a small percentage of lftb is added to ground beef, it cannot possibly make ground beef safer and to think otherwise is faulty logic. furthermore, these same critics argue that regardless of whether lftb is safe for human consumption, "the products should be labeled so that consumers will be able to choose whether to purchase it."29 whether or not beef products containing lftb should be labeled as such has become the primary focus of the lftb debate. proponents of lftb argue that a mandate requiring disclosure of lftb on food labels should never be passed because mandatory labeling of lftb is unconstitutional. 3 0 without scientific evidence that lftb "poses a health hazard or is nutritionally inferior," or serves a substantial governmental interest, supporters of lftb claim that a law requiring labeling of lftb "would run afoul of the first amendment . ... .31 furthermore, proponents explain that food labeling is a form of commercial speech protected by the first amendment, and as a result, there are limits to congress's power to mandate disclosures on food labels. 32 in international dairy foods association v. amestoy, the second circuit court of appeals ruled that "consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement in a commercial context."33 the court of appeals goes on to explain that if there is a reasonable concern for human health or safety, disclosure may be required. 34 the supreme court, however, has yet to rule on this issue. in the case of lftb, increased levels of ammonia and alkaline, if proven unsafe, would remove potential first amendment legal challenges to the required labeling of lftb. critics of lftb do not consider lftb "ground beef' and 28 frank & hahn, supra note 8, at 3. 29 id. at 5. 30 id. at 6. 31 id 32 id. 33 inf idairy foods assin. v. amestoy, 92 f.3d 67, 74 (2nd cir. 1996). 34 id 478 vol. 10: 2 "pink slimie" and the i real beef act contend that not including lftb on food labels is a form of fraudulent labeling.35 congresswoman chelli pingree helped voice the concern of lftb critics by introducing the real beef act to congress, which would require "that beef containing lftb be labeled to disclose that fact to the end purchaser."36 lftb supporters, however, caution those in favor of including lftb on food labels because doing so creates another set of problems. according to the american meat institute ("ami"), "if [lftb1 is not used in fresh ground beef products, approximately 1.5 million additional head of cattle would need to be harvested annually to make up the difference." 37 as a result, consumers could end up paying higher prices for lftb free ground beef.38 u.s. regulators are also concerned that requiring food labels to include lftb might "open the floodgates" to including several processing aids on food labels that only show up at low levels. 39 finally, lftb advocates claim that there is no need to include lftb as an ingredient on food labels because "nothing is being added that is not beef."40 iv. legislative history and the proposed real beef act given the importance of meat in the nation's total supply of food, "it is essential . .. that meat and meat food products . . . are properly marked, labeled and packaged." 41 the labeling of meat products is governed by the federal meat and inspection act ("fmia"). one of the goals of the fmia 35 bottemiller, supra note 16. 36 bettina elias siegel, congresswoman pingree introduces the real beef act (requiring easy and accurate labeling), lunch tray (mar. 30, 2012), http://www.thelunchtray.com/congresswoman-pingreeintroduces-the-the-real-beef-act-requiring-easyand-accurate-labeling/. 37 questions and answers about lean finely textured beef american meat institute, www.meatami.com/ht/a/getdocument actionli/76184 (last visited apr. 07, 2013). 38 greene, supra note 3, at 8-9. 39 bottemiller, supra note 16. 40 id. 41 21 u.s.c. § 602 (2012). 4792013 indiana health law review is to regulate meat and meat food products that may be injurious to consumers because they are misbranded. 42 critics of lftb have turned to the fmia to push for the inclusion of lftb on food labels. to determine which elements of food production must be included in the ingredients list on food labels, it is important to understand the distinction between ingredients and processing aids. a. ingredients vs. processing aids both ingredients and processing aids can fall within the guidelines of gras. typically, gras is a classification used for ingredients; however, numerous processing aids are also recognized as gras and are allowed in food production. according to the fda, an ingredient or food additive is "any substance the intended use of which results or may reasonably be expected to result directly or indirectly in its becoming a component or otherwise affecting characteristics of any food." 4 3 elements of food production that fall into this category are required on food labels because they are found at significant levels in the final product and technically alter the final product. 44 alternatively, processing aids are not found at significant levels and have no "functional or technical effects" on the final product. consequently, processing aids are not required in ingredients lists on food labels. drawing the line between ingredients and processing aids can be difficult. dr. richard raymond, former undersecretary for food safety at the usda, asserts that there is not an "exact science" on the classification of processing aids, and as a result, "some processes get excluded from the club."4 5 the recent controversy 42 id 43 overview of food ingredients, additives and colors, fda.gov (apr. 2010) http://www.fda.gov/food/ingredientspackaginglabeling/food additiveslngredients/ucm094211 .htm. 44 d. 45 james andrews, processing aids, labeling and pink slime' food safety news (mar. 26, 2012), http://www.foodsafetynews.com/ 2012/03/processing-aids-labeling-and-pink-slime/. 480 vol. 10: 2 "pink slime" and 'he real beei' act 4 surrounding the use of "meat glue" in beef products is a good example of the line drawing problem between ingredients and processing aids. meat glue is well known in the food industry practice. 46 meat glue is a combination of transglutaminase ("tg") and beef fibrin, which are enzymes that bind proteins together, allowing different cuts of meat to mold together to form a uniform size. 4 7 according to food service providers, meat glue "allow [s] for flexibility in the sizes and shapes of cuts they serve patrons, . . . which is especially helpful if [you are] serving a large number of people."4 8 meat glue can also be found in other food products including imitation crabmeat, pasta, and dairy products. 49 nonetheless, some question the practice, claiming that "it is possible that different cuts put together could be more susceptible to contamination by potentially introducing pathogens into the center of a pieced-together steak."50 unlike the lftb controversy, whether tg and beef fibrin should be included on food labels is not at issue. the usda recognizes tg and beef fibrin as ingredients, and as a result, food manufacturers are federally required to include tg and beef fibrin on food labels. 51 consumers, however, are not likely to see tg or beef fibrin on food labels because the most common use of the enzymes is at the food service level. 52 the classification of meat glue as an ingredient is somewhat puzzling because it has characteristics of a processing aid according to the fda's definition (see below), but it is recognized as a gras substance, similar to lftb. without more guidance from the usda, determining what 46 helena bottemiller, meat industry defends 'meat glue'as safe, no secret, food safety news (may 11, 2012), http://www.foodsafety news.com/2012/05/meat-industry-defends-meat-glue-as-safe-no-secret/. 47 id. 48 id 49 james b. kelleher, industry defends ingredient critics deride as meat glue' chicago tribune (may 11, 2012), http://articles.chicago tribune.com/2012-05-11/news/sns-rt-usa-foodmeat-gluel4e8gb8xz2o1205 11_1 ammonia-treated-beef-ground-beef-beef-products. 50 bottemiller, supra note 45. 51 id 52 i[d 2013 481. indiana health law review should qualify as an ingredient or processing aid will continue to present challenges when it comes to properly labeling substances used in meat food products. b. lftb is considered a processing aid under current fda regulations under current fda regulations, lftb is considered a processing aid. processing aids fall into one of three categories: (1) substances that are added to a food during its processing but that are removed in some manner from the food before it is packaged in its finished form; (2) substances that are added to a food during processing, are converted into components normally present in the food, and do not significantly increase the amount of the constituents naturally found in the food; or (3) substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food. 53 the third category is "widereaching" and includes a number of substances, including ammonia.54 although a substance may be gras, it may not be suitable in the production of meat. the food safety and inspection service ("fsis"), the public health agency in the usda, determines whether a gras substance is safe for use in meat production.55 the fsis concluded that ammonia is a safe and suitable ingredient used in the production of meat if used as a ph control agent in brine solutions or as an agent to kill microbes from beef carcasses and boneless beef trimmings. 56 when used in lftb, ammonia serves to kill microbes, making the pink slime 53 21 c.f.r. 101.100 (a)(3) (2013). 54 andrews, supra note 44. 55 vanessa k. burrows & cynthia brougher, cong. research serv., r34247, federal regulation of substances generally recognized as safe (gras) and the use of carbon monoxide in packaging for meat and fish 12 (2008). 56 fsis directive 7120.1, safe and suitable ingredients used in the production of meat, poultry, and egg products, (u.s.d.a. 2012), available at http'//wwwfsis.usda.gov/oppdfad~t/esisdietivesf7120. 1.pdf 482 vol. 10:2 "pink slime" and the real beef act safe for meat production. therefore, according to the fda and usda, ammonia is a gras processing aid used in meat production and does not have to be included in the ingredient lists on food labels. since lftb is a mixture of ammonia and ground beef, it too is recognized as a processing aid and, thus, food makers are not required to list it on the labels of ground beef products. as a result, critics of lftb have turned to the fmia to push for the inclusion of lftb on food labels. c fmia & the real beef act section 601(n)(11) of the fmia states that the term misbranded applies to "any carcass . . . meat or meat food product . .. if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact.5 7 as previously mentioned, the real beef act, if approved, would amend section 601(n)(11) of the fmia to require labels on packages of meat to include a statement on whether the meat contains lftb.58 specifically, the real beef act would amend the fmia to provide that a meat product is misbranded if "at the final point of sale it contains low-temperature rendered product," also known as lftb, "unless it bears a label stating that it contains such product."59 the intent of the real beef act is to notify consumers about the presence of lftb, so they can make an informed decision about the food they eat. the real beef act, however, does not specify how much lftb must be present in the ground beef, 60 and does not state whether the real beef act's labeling requirement would apply to restaurant menus. v. implications of the real beef act on the restaurant industry the real beef act is silent about whether it applies to 57 21 u.s.c. § 601 (2012). 58 requiring easy and accurate labeling beef act, supra note 1. 59 id. 60 frank & hahn, supra note 8, at 5. 4832013 indiana health law review restaurants, and, thus, a strict reading of the real beef act suggests that restaurants might not be required to disclose the use of lftb on their menus. silence, however, does not necessarily mean that legislators did not intend for the real beef act to apply to the restaurant industry. in fact, the reluctance to pinpoint a particular industry or food establishment may have been intended because it allows for broad application of the real beef act. a. the real beefact does not apply to restaurants according to congresswoman pingree, if a beef product contains lftb, "[consumers] ought to be able to know that when [they] pick it up in the grocery store."6 1 pingree's statement implies that the real beef act may only apply to grocery stores. in addition, the express language of the real beef act favors the idea that the real beef act only applies to grocery stores. the real beef act states that lftb sold in a package or container at the final point of sale without proper labeling would be deemed misbranded.62 since the real beef act refers to beef products provided in a package or container, restaurants may not be subject to the real beef act. restaurants deliver their final product to consumers much differently than grocery stores. when a customer dines at a restaurant, the food product is not provided in a package or container at the final point of sale63 unless the customer places a to-go order, similar to a fast food establishment. in the case of a to-go order, the meat or meat food product is provided in a package or container and normally presented to the customer at the final point of sale. this suggests that restaurants would not be required to disclose the presence of lftb on menus for customers 61 introducing real beef act to require pink slime labeling, pingree.house.gov (mar. 30, 2012), http://pingree.house.gov/index.php? option=comcontent&task=view&id=776&itemid=24. 62 requiring easy and accurate labeling beef act, h.r. 4346, 112th cong. § 2(d) (2012). 63 definition of point of sale, investopedia, http:/wwwinvestopedia com/terms/p/point-of-sale. asp#axzz22pyorccj (lastvisited mar. 07,2013). 484 vol. 10:2 "pink slime" and the real bee act who eat at the restaurant, but disclosure would be required for customers who take their food home instead. this inconsistency should give restaurants pause when it comes to menu labeling. the fmia's definition of label and labeling, however, also suggests that the legislation was aimed at grocery stores rather than restaurants. the fmia defines label as a "display of written, printed, or graphic matter upon the immediate container . . . of any article" 64 and defines labeling as "all labels and other written printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article."65 while both definitions refer to the labeling of containers or packages, neither definition mentions menu labeling. this omission further suggests that the real beef act would not amend the fmia to apply to restaurants. finally, according to the usda, tg and beef fibrin used in meat glue are considered ingredients and must be indicated in the ingredients list on food labels. as mentioned supra, consumers are not likely to see tg or beef fibrin on food labels because the most common use of the substances is at the food service level.6 6 similar to meat glue, lftb is used at the food service level. since restaurants will be serving lftb at the food service level and it is recognized as a processing aid, it is unlikely that restaurants will have to disclose the use of lftb on menus. applying the real beef act to grocery stores is more straightforward than applying the real beef act to restaurants. if the real beef act only applies to grocery stores, restaurants would not have to disclose the use of lftb on their menus. fast food establishments and restaurants that prepare to-go orders, however, may be required to disclose the use of lftb on any package or container that is used to serve their food products. therefore, whether a restaurant is subject to the real beef act may be determined simply by how they present their food products to consumers. 64 21 u.s.c. § 601(o) (2012). 65 id. at § 601(p). 66 bottemiller, supra note 45. 2013 485 indiana health law review b. the real beefact applies to restaurants according to congresswoman pingree, the real beef act is about choice and transparency. 67 pingree explained that while consumers may not have a choice about whether lftb is used in beef products, they should be able to choose whether they want to buy beef products containing lftb.68 consumers, however, cannot make that decision "unless they know whether or not [lftb is] in the product they are buying."6 9 in other words, the real beef act aims to give consumers accurate information regarding the presence of lftb in their food, and allows them to make an informed decision about whether they want to purchase the food product. this broad explanation suggests that the real beef act is intended to apply to all food service providers that use lftb, including restaurants. transparency in the restaurant industry would require some form of labeling, most likely on the menu, so that consumers can identify what menu items contain lftb and avoid ordering those items if they so choose. menu labeling seems to be the most logical place to disclose the presence of lftb in meat products, because the majority of consumers will look at the menu before they order. it is likely that restaurants will only have to disclose the presence of lftb, which can be easily added to the description of the menu item. for example, an entr6e that includes beef such as spaghetti may list the ingredients under the menu item as follows: spaghetti whole wheat noodles, marinara sauce, ground beef (lftb used). a blanket statement on the menu that states that 'all beef products are made with lftb" may also suffice. such a label is clear and may encourage customers to inquire about the presence of lftb in their specific entree. even if the real beef act does not directly apply to restaurants, it may cause restaurants to voluntarily disclose 67 introducing real beef act to require pink slime labeling, pingree.house.gov (mar. 30, 2012), http://pingree.house.gov/index.php? option=comcontent&task=view&id=776&itemid=24. 6 9 id 6 9 id. 486 vol. 10: 2 "pink slime" and the real beef act the presence (or absence) of lftb on their menus. the usda, which runs the school lunch program, gave school districts the choice of ordering ground beef that contains lftb.70 as a result, only three states have chosen to continue to use ground beef products containing lftb.71 similarly, popular fast food establishments have voluntarily chosen not to use lftb in their ground beef products. 72 given the customer backlash surrounding lftb and customers' insistence on properly labeling lftb, restaurants may voluntarily choose to disclose the use of lftb. again, it is about transparency and choice, and customers might feel more comfortable eating at a restaurant that is upfront and honest about the products they serve. 73 some may argue that restaurants could lose business by disclosing such information because customers will choose not to eat there. 74 that might not be the case, however. first, customers might be hesitant to eat at a restaurant that does not disclose the use of lftb because they want more transparency about what they are consuming.75 second, disclosing the use of lftb does not mean that customers will choose not to buy the product.76 many customers may be okay with eating beef products containing lftb, but they may simply want to know when 70 bettina elias siegel, usda to allow voluntary labeling of lftb, branstad requests congressional hearing, lunch tray (apr. 02, 202), http://www.thelunchtray.oom/breakingusda-to-allw-voluntary-labeling-oflfb-branstadrequests-cngressional-hearing/. 71 most schools opt out of 'pink slime" in lunches, usda says, cbs news (june 5, 2012), http://www.cbsnews.com/8301-504763_1625744762110391704/most-schools-opt-out-of-pink-slime-in-lunches-usdasays/. 72 matthew rosenbaum, mcdonald's announces end to pink slime' in burgers (feb. 01, 2012), http://abcnews.go.com/blogs/health/ 2012/02/0 1/mcdonalds-announces-end-to-pink-slime-in-burgers/ (noting that mcdonalds, taco bell, and burger king no longer purchase beef with lftb in them). 73 ashley arthur, note, combating obesity. our country's need for a national standard to replace the growing patchwork of local menu labelinglaws, 7 ind. health l. rev. 305, 325. (2010). 7 4 id. 75' seeid. at 325-26. 7 6 id. 4872013 indiana health law review they are doing so. furthermore, if one restaurant voluntarily discloses the use of lftb, it may put more pressure on other restaurants to do the same. as a result, disclosing the use of lftb on menus could become an industry standard, which can have the same impact as a regulation. if legislators agree with congresswoman pingree that the intent of the real beef act is to provide customers with transparency and choice concerning the food products they consume so they can make an informed decision, then it is likely the real beef act would apply to restaurants. consequently, restaurants would be required to disclose the presence of lftb in food products, which would most likely be placed on their menus. vi. jurisdictional issues posed by state truth-in-menu regulations jurisdictional issues related to ground beef products sold in restaurants77 may make practical application of the real beef act cumbersome. even if the real beef act did not have the effect of federally mandating that restaurants disclose the use of lftb, proponents of the real beef act claim that "many states' truth-in-menu laws would have the effect of applying the bill's disclosure requirement to menus."78 while the idea of relying on state truth-in-menu laws to enforce disclosure requirements to menus is plausible, it may not be likely. today, truth-in-menu laws are governed by various agencies and administrative entities seeking to make labeling of food more accurate. 79 still relatively new, truth-in-menu laws are constantly being revised, and, in most states "[r]estaurants are not currently required to divulge their ingredients lists [recipes] to their guests."80 77 frank & hahn, supra note 8, at 5. 78 id 79 truth in menus managing hospitality risk, national specialty underwriters, inc., http://www.nsui.com/wp-content/uploads/2012/07/ mhrmenus.pdf (last visited apr. 07, 2013). 80 id 488 vol. 10:2 "pink slime" and the real beef act a comprehensive search of the laws of every state reveals that only seven states have laws that address the labeling of ingredients on restaurant menus. the seven states are california, hawaii, illinois, south dakota, minnesota, new jersey, and rhode island. of those states, california, hawaii, illinois, minnesota, and south dakota have laws that addressing the use of imitation hamburger sold or served in restaurants. generally speaking, these laws state that if imitation hamburger is sold or served in restaurants, a list of the ingredients must appear on the menu. each state, however, defines imitation differently and has varying menu labeling requirements. new jersey and rhode island's truth-in-menu laws focus on the misrepresentation of identity on food menus. a. california in california, if imitation hamburger is sold or served in a restaurant a list of ingredients thereof shall appear on the menu, . . . [but] no list of ingredients . . . shall be required for imitation hamburger that contains not more than 10 percent added protein and water, and that does not contain other binders or extenders. 81 although california addresses disclosure of ingredients related to hamburger meat on restaurant menus, california's truth-in-menu law is not directly on point with requiring disclosure of lftb. section 111200 of california's health and safety code, defines imitation hamburger as "chopped fresh or frozen beef, or a combination of both fresh and frozen beef, with or without the addition of beef fat . .. [that] may contain binders and extenders, with or without the addition of partially defatted beef tissue."82 as previously mentioned, lftb is derived from ground 81 cal. health & safety code § 111205(a) (2012). 82 cal. health and safety code § 111200(b) (2012). 4892013 indiana health law review beef. moreover, it does not contain any binders or extenders. as a result, lftb would not fall under the definition of imitation hamburger according to california law. additionally, provided that lftb meets the less than 10% threshold for added water and protein, the exception would apply. therefore, california's truth-in-menu laws, as they currently stand, are not likely to force restaurants to disclose the use of lftb on their menus. b. ha wai, illinois, and south dakota under hawaii, illinois, and south dakota law, any "imitation food or hamburger," or "substitute food product" sold in a restaurant is prohibited, unless the menu discloses such information. 83 unlike california, the truth-in-menu laws in hawaii, illinois, and south dakota do not define imitation, making it more difficult to determine whether restaurants would have to disclose the presence of lftb. if these states did define imitation similar to california, it is likely that their truth-in-menu laws would not require restaurants to disclose the presence of lftb for the same reasons that apply in california. south dakota's law is more restrictive than hawaii and illinois because it only applies to "imitation hamburger." 84 lftb, however, can be added to various beef products such as lunch meats. therefore, in south dakota, restaurants would only be required to disclose the presence of lftb in hamburger meat products. however, it is not clear whether restaurants would have to disclose in that case either, because as mentioned, south dakota does not provide an adequate definition for imitation, and lftb is made from ground beef. c minnesota according to minnesota statute, "[alny restaurant, eating place, or other establishment serving meat . . . that has any filler or meat . . . substitute added to it or 8 haw. rev. stat. § 328-6 (2012); 410 ill. comp. stat. § 650/10.1 (2012); s.d. codified laws § 34-18a-7 (2012). 84 s.d. codified laws § 34-18a-7 (2012). 490 vol. 10:2 "pink slime" and the real beef act incorporated in it, shall clearly and prominently indicate on its menu or bill of fare the meat entrees that contain filler."85 industry experts, including the usda, agree that lftb is a meat filler that helps reduce costs. 86 as a result, restaurants in minnesota would be required to disclose the presence of lftb on their menus or bill of fare. currently, however, there do not appear to be any instances of minnesota restaurants enforcing disclosure of lftb on their menus. d. rhode island and new jersey rather than address the particular ingredients in food products, both rhode island and new jersey truth-in-menu laws focus on the misrepresentation of identity on food menus. generally speaking, under the laws of each jurisdiction, it is unlawful for restaurants to "misrepresent on any menu . .. the identity of any food or food products."87 unfortunately, new jersey does not offer guidance on how to determine whether the identity of a food item is misrepresented. in rhode island, however, the identity of a food item is misrepresented if "[ilt purports to be or is represented as a food or food product for which a definition of identity and standard of quality has been established by custom and usage."88 critics of lftb would argue that lftb does not meet the standard for ground beef established by custom because lftb contains increased amounts of ammonia not custom in lftb free ground beef. critics would also argue that lftb changes the appearance of ground beef to make it appear "as red meat."89 85 minn. stat. § 31.633 (2012). 86 sarah kidmore, supermarkets join move away from pink slime' beef filler, usa today, (mar. 22, 2012), http://www.usatoday. com/moneylindustries/food/story/201203-22/pinkslime-supervalu-foodlion-safeway/53700356/1. 87 n.j. stat. ann § 56:8-2.9 (2013); see also r.i. gen. laws § 23-140(a) (2012). 88 r.i. gen. laws § 23-1-40(b)(4) (2012). 89 jim avila, beef products inc. comebackit's not pink slime',' it's safe, nutritious and 'it's beef, abc news (mar. 27, 2012), http:/ 2013 491 indiana health law review on the other hand, proponents of lftb would argue that the presence of lftb in ground beef does not alter the quality standard of ground beef. in fact, lftb may improve the standard because it makes ground beef leaner. given the arguments on both sides, it is unclear whether rhode island's truth-in-menu law would apply to restaurants. clearly, if rhode island sides with the critics of lftb, restaurants would be required to disclose the presence of lftb on their menus. each of the seven states, with the exclusion of minnesota, offer vague truth-in-menu laws that mainly address the use of imitation food products. without more definitive laws that provide adequate definitions concerning imitation products, it is unlikely that these states would impact restaurant menu labeling when it comes to disclosing the presence of lftb in food products. vii. conclusion on april 12, 2012, the real beef act was referred to the house subcommittee for review.90 although the bill is still under review, the usda has already endorsed the idea of labeling ground beef containing lftb. 91 essentially, usda inspectors will certify that voluntarily labeled "lftb free" ground beef "will be inspected to ensure it is true to its new label."92 moreover, the usda also announced that it will allow school districts that participate in the national school lunch program to decide whether or not to buy abenews.go.com/business/beef-products-comeback-pink-slime-safenutritious-beef/story?id=16014232#.uaxyny4wb8s. 90 requiring easy and accurate labeling beef act, supra, note 1. 91 jim avila, are lftb or pink slime' safety claims meaningful to consumers? abc news (apr. 03, 2012), http://abcnews.go.com/blogs/ headlines/2012/04/are-lftb-or-pinkslime-safety-claims-meaningful-toconsumers/. 92 id. 492 vol. 10:2 "pink slime" and the real beef act ground beef that includes lftb.93 it remains unclear how restaurants should approach menu labeling when it comes to lftb. even if the real beef act is passed, it does not expressly state that restaurant menus should be labeled to include the presence of lftb in meat food products. given the intent of the real beef act, however, it is plausible that the it could apply to restaurants. provided the real beef act will apply to restaurants, the restaurant industry as a whole will have to be more diligent about informing customers about the use of lftb either through menu labeling or posted signs. for now, at least, food servicers, restaurants, and fast food establishments should closely monitor the passage and implementation of the real beef act and how it will be applied to the restaurant industry. 9 usda announces additional choices for beef products in the upcoming school year, usda.gov (march 15, 2012), http://www.usda. gov/wps/portal/usda/usdahome?contentidonly=true&contentid=2012/03/ 0094.xml ("by law, usda has two primary responsibilities as part of its mandate to provide safe and nutritious food to the american people. through the food safety and inspection service, usda ensures that safety of the nation's commercial supply of meat, poultry, and processed egg products. through the food and nutrition service and the agricultural marketing service, usda provides food and nutrition assistance through several domestic programs, including the national school lunch program."). 2013 493 james f. blumstein professor blumstein holds a b.a. in economics from yale college, an m.a. in economics from yale university, and an llb. degree from yale law school, where he was an editor of the yale law journal. he is currently university professor of constitutional law and health law and policy at vanderbilt university, the director of the health policy center of the vanderbilt institute for public policy studies, and an adjunct professor of health law at dartmouth medical school. he has served as the john m. olin visiting professor of law at the university of pennsylvania law school, and as a visiting associate professor of law and policy sciences at duke law school. professor blumstein is an elected member of the institute of medicine (iom) of the national academy of sciences and has served as a member of an 10m committee on the adequacy of nurse staffing in hospitals and nursing homes, and as a member of the advisory panel on the study of defensive medicine and the use of medical technology, office of technology assessment. he has won vanderbilt's university-wide award for lifetime research achievement (the sutherland . prize) and the law school's award for teaching (the hartman award). he has litigated constitutional issues in state and federal courts, including, most recently, brentwood academy v. tennessee secondary school athletic association (tssaa), 531 u.s. 288 (2001}, and tssaa v. brentwood academy, 127 s.ct. 2489 (2007). of doctors and hospitals: setting the analytical framework for managing and regulating the relationship * james f. blumstein .. table of contents i. introduction ............................................................................... 211 ii. background and overview ...................................................... 214 (1) ................................................................................................... 214 (2) ................................................................................................... 216 (3) ................................................................................................... 218 ill. ways of thinking about medical care: the different models .......................................................................................... 219 a. the professional/scientific model: its assumptions and implications .............................................................................. 220 b. the market-oriented model: its assumptions and implications .............................................................................. 220 iv. the hospital as the embodiment of the professional/scientific model. ............................................... 222 v. the evolving external environment and its impact.. ....... 225 a. quality ofcare ......................................................................... 225 b. cost containment ..................................................................... 228 vi. the evolution of integrated delivery networks .............. 230 a. competing hypotheses and rationales .................................... 230 b. the evidence ............................................................................ 231 vii. physician-hospital interaction: the future ....................... 232 i. introduction the issues surrounding the movement toward integration of physician services and the institutional and economic interests ofhospitals raise some of the most critical, delicate, and longstanding health policy and law issues con­ fronting analysts and policymakers. • this article is derived from the mcdonald merrill ketcham lecture, delivered in february 2007. •• university professor of constitutional law and health law and policy, vanderbilt university, nashville, tennessee. director, health policy center, vanderbilt institute for pub­ lic policy studies, nashville, tennessee. the research assistance of jeffrey breen, class of2007 at vanderbilt law school, is gratefully acknowledged. 212 indiana health law review [vol. 4:209 1. how, and to what extent, should economic considerations factor into medical care decision making? that is, what is the proper relationship between technical medical/scientific factors and economic factors in the medical care decision making context? one traditional viewat one end of a continuum­ suggests that the very introduction of economics into medical care decision making corrupts medical judgment and therefore should be avoided.1 in that view, such conduct is sanctionable, even subject to punitive damages.2 in some circles, this is still a prevalent point of view/ but some courts have recognized the inevitability of including economic factors in physician practice styles4 while also recognizing that there are limits to the consideration of economics­ a point beyond which the compromising of professional standards can fairly be labeled as the corruption of medical judgment. 5 2. what is the appropriate role of physicians, as expert autonomous pro­ fessionals, in medical care decision making, and, correlatively, what are the appropriate legal, institutional, and regulatory structures to shape that role?6 dealing with that set of questions quickly turns to a consideration of different ways of thinking about medical care about different paradigms or models and their assumptions and implications. 7 the hospital formatively was struc­ tured in reliance on and in response to one way of thinking about medical care -the professional-scientific paradigm. over time, legal obligations and finan­ cial responsibilities have redefined and reshaped the hospital. hospitals now typically have independent duties to patients8 and responsibility for the quality 1 see, e.g., muse v. charter hosp. of winston-salem, inc., 452 s.e.2d 589 (n.c. ct. app. 1995), affd per curiam, 464 s.e.2d 44 (n.c. sup. a. 1996). 2 id. 3 for a general discussion of these issues, see james f. blumstein, health care law and policy: whence and whither?, 14 iiealtii matrix 35 (2004). 4 see, e.g., pegram v. herdrich, 530 u.s. 211 (2000) (recognizing the need to consider cost-benefit trade-offs in the managed care context); sarka v. regents ofuniv. of cal., 52 cal. rptr. 3d 810 (cal. a. app. 2006) (allowing the student health service to terminate employment of a staff physician for relying too heavily on testing and too little on less expensive clinical medical judgment). 5 see wickline v. state, 239 cal. rptr. 810,820 (1986), rev. dismissed, 741 p.2d 613 (1987) (recognizing necessity for and validity of cost-containment programs, but noting that "it is essential that cost limitation programs not be permitted to corrupt medical judgment."). 6 for an important discussion of this issue, see m. gregg bloche, tnjst and betrayal in the medical marketplace, 55 stan. l. rev. 919 (2002). for a different perspective, see mark a. hall, law, medicine, and tnjst, 55 stan. l. rev. 463 (2002). 7 see, e.g., james f. blumstein, health care rliform and competing visions of medical care: antitrust and state provider cooperation legislation, 19 cornelll. rev. 1459, 1459, 1463-86 (1994) (examining "the competing visions of medical care represented by the profes­ sional and the market-based economic paradigm" and "consider[ing] the implications of those visions for the development of public policy.") [hereinafter blumstein. competing v"lsions]. for a skeptical view of the market-based alternative to the traditional professionaj/scienti:fic model, seem. gregg bloche, the invention of health law, 91 cal. l. rev. 247 (2003). 8 sword v. nkc hosps., inc., 714 n.e.2d 142 (ind. 1999) (adopting corporate negli2007] of doctors and hospitals: se'iting the analytical framework 213 of care that occurs within their walls. hospitals also have a responsibility to manage within economic parameters and to take into consideration the hospi­ tal's institutional interest in quality assurance, marketing and patient flow, and cost containment. these new environmental realities call into question the traditional "work­ shop" model,9 in which the hospital serves a role somewhat analogous to that of ebay, as a forum or catalyst for the practice of medicine and for the diagnosis and treatment of patients, but with few or no independent institutional interests at stake. new realities also call into question the tight regulatory vision of the hospital, with a separate medical staff with its own bylaws and, in some juris­ dictions, independent legal status. 10 this traditional hospital structure has turned out to be ill-suited for certain new roles being thrust on hospitals. inte­ grated delivery networks ("idns") (of which physician-hospital joint ventures are an example) have emerged over the past twenty years in part as a response to these new, largely economic, circumstances and in part as a result of the adaptivity constraints on hospitals that stem from a tight, one-size-fits-all regu­ latory structure that traditionally has defined the organization and governance ofhospitals. part of this article will describe evidence ofhow these idns have emerged and how they have worked. this article will conclude that the regulatory flexibility that currently governs idns, as contrasted with hospitals, is desirable because it allows re­ sponsiveness to new circumstances in the marketplace, even though the evi­ dence ofidn performance is not what some of its advocates might have hoped for to this point. nevertheless, although overall regulatory rigidity towards idns is modest, idns still face regulatory landmines, such as the anti-kickback law, 11 which could adversely affect idns' ability to adapt and respond to changes in health care and the health care marketplace.12 gence standard for hospital liability). 9 for a discussion of different models of the role of the hospital, see james f. blumstein & frank. a. sloan, antitrust and hospital peer review, law & contemp. probs., spring 1988, at 7, 18-24; philip c. kissam et al., antitrust and hospital privileges: testing the conventional wisdom, 70 cal. l. rev. 595 (1982); mark v. pauly & martin redisch, the not-for-profit hospital as a physicians' cooperative, 63 am. econ. rev. 87 (1973). 1° compare lewisburg cmty. hosp., inc. v. alfredson, 805 s.w.2d 756 (tenn. 1991) (holding medical staffbylaws to be a source of enforceable contract rights) with mason v. cent suffolkhosp., 819 n.e.2d 1029 (n.y. 2004) (holding that medical staffbylawscannotserveas the basis for damages litigation). 11 for discussions of the landmines imposed on market-oriented approaches by the anti­ kickback law, see james f. blumstein, the fraud and abuse law in an evolving health care marketplace: life in the healthcare speakeasy, 22 am. j. l. & med. 205 (1996) [hereinafter blumstein, speakeasy]; james f. blumstein, rationalizing the fraud and abuse statute, healrnaff., winter 1996, at 118. 12 for a discussion of general legal problems associated with different idn forms, see carl h. hitchner et al., integrated delivery systems: a survey of organizational models, 29 wake forest l. rev. 273 (1994); see also john d. blum, beyond the bylaws: hospital­ physician relationships, economics, and conflicting agendas, 53 buffalo l. rev. 459 (2005) (exploring physician-hospital relations in the current marketplace context). 214 indiana healtii law review [vol. 4:209 a demonstration project to be initiated in 2007 and to run for several years is designed to determine the risks and benefits of gainsharing, 13 in which physicians and hospitals better align incentives to achieve quality assurance and cost containment objectives. 14 that demonstration should provide a vehicle for assessing, more broadly, the appropriate regulatory structure for ions and hos­ pitals. the existing anti-kickback law may have ample flexibility through its safe harbor provisions and advisory opinion process to modify its unforeseen adverse impact on potentially constructive organizational restructuring in a changed, market-driven environment. in general, this article concludes that a regulatory regime should maintain flexibility and the ability to adapt to entrepreneurial opportunities. regulatory strategy should reduce its emphasis (as in traditional hospital regulation) on micromanaging details of how organizations and institutions are structured. greater emphasis should be placed on consequences to worry about, such as anti-competitive effects or poor-quality outcomes. the objective of regulatory policy should be to develop a regulatory regime that is neutral to organizational form and that allows institutions and physicians to cooperate or compete ac­ cording to market conditions, provided that competitive conditions are main­ tained and quality outcomes are properly encouraged. ll. background and overview (1) just over thirty years ago, clark: havighurst and i made the case that eco­ nomics had an important role to play in medical care decision making.15 trade­ otis had to be made in the allocation of medical care resources, and institutional design was important in structuring decision making so that someone had an incentive to consider costs in resource allocation matters. 16 the battle over the soul ofpsrosprofessional standards review or­ ganizationswas the context in which organized medicine attempted to tamp 13 for a discussion of gainsharing and physician financial incentives, see richard s. saver, squandering the gain: gainsharing and the continuing dilemma of physician finan­ cial incentives, 98 nw. u. l. rev. 145 (2003). 14 see ctrs. medicare & medicaid servs., u.s. dep't health & human servs., physician­ hospital collaboration demonstration, http://www.cms.hhs.gov/dem.oprojectsevalrpts/downloads/phcd _ 646 _solicitation. pdf (demonstration project description and request for proposal). 15 clark c. havighurst & james f. blumstein, coping with quality/cost trade-offi in medical care: the role of psros, 70 nw. u. l. rev. 6 (1975). 16 id. for other discussions of the importance of institutional structure and design, see james f. blumstein, constitutional perspectives on governmental decisions affecting human life and health, law & contemp. probs., autumn 1976, at 231; clark c. havighurst et al., strategies in underwriting the costs of catastrophic disease, law & contemp. probs., au­ tumn 1976, at 122. 2007] of doctors and hospitals: setting the analytical framework 215 down the emerging policy concerns associated with rapidly escalating costs on public budgets as a result of medicare and medicaid. psros were designed as professionally-controlled peer review organization networks to help reduce the rate of increase in medicare and medicaid costs. organized medicine aggres­ sively sought to redirect the focus of the program to promotion ofhealth care quality, resisting the cost-containment mission ofpsro originators.17 thirty­ five years later that battle continues to rage; psros still exist, but the name of the organizations has morphed to peer review organizations ("pros")/8 and, most recently, quality improvement organizations ("qios"), 19 demonstrating that the naming and renaming of these entities reflect the agendas being pur­ sued.z0 a critical component of the havighurst and blumstein analysis was to draw a distinction between waste control and cost control. waste control is the zero-benefit circumstance, what has come to be called "flat of the curve" medi­ cal care. eliminating zero-benefit diagnoses and treatments is uncontroversial, and politicians love the discourse, because it seems that policy makers can achieve something for nothing -lower cost at no reduction in quality through the realization of true economies (i.e., improved efficiency). undoubtedly, as john wennberg and colleagues have shown, the opportunity for achievement of true economieselimination of truly wasteful careis available and should be pursued. 21 but, from an economics perspective, a more ambitious agenda is to challenge an incentive structure that results in high-cost care with small but only marginal benefits. the problem of cost control (as distinct from waste control) is "marginally productive, not unproductive, care.'.n care deemed "unnecessary'' is "neither wholly useless nor affirmatively harmful" but "could be rendered effectively and appropriately in a shorter time, in a less sophisti­ cated facility, or on an outpatient basis.'.23 in sum, a regime of cost control 17 see havighurst & blumstein, supra note 15, at 42 n.123 (discussing organized medi­ cine's efforts to reorient the psro program from cost containment to quality assurance). 18 the psro program became the pro program in 1982. timothy stoltzfus jost, ad­ ministrative law issues involving the medicare utilization and quality control peer review organization (pro) program: analysis and recommendations, 50 omo st. l.j. 1, 5 (1989). 19 inst. of med., medicare's quality improvement organization program: maximizing potential 19-32 (2006) (describing and providing an overview ofqio program). 2° for a proposal to use qios' authority to confer medical malpractice immunity in cer­ tain circumstances, see james f. blumstein, medical malpractice standard-setting: developing malpractice "safe harbors" as a newroleforqios?, 59 vand. l.rev. 1017(2006). 21 see, e.g., john e. wennberg, variation in use of medicare services among regions and selected academic medico/ centers: is more better?, the commonwealth fund publication no. 874, dec. 13, 2005, at 4 (noting "striking regional variations in the proportion of early stage breast cancer patients who undergo lumpectomy" and identifying "idiosyncratic practice style" as the "major source of such widely varying discretionary surgery rates."). 22 mark a. hall, institutional control of physician behavior: legal barriers to health care cost containment, 137 u. pa. l. rev. 431,444 (1988) [hereinafter hall, institutional control of physician behavior]. 23 havighurst & blumstein, supra note 15, at 32. 216 indiana health law review [vol. 4:209 would result in some forgoing of marginally beneficial care as insufficiently justified based on an evaluation of costs and benefits. this idea later gained traction in managed care, although that movement was not forthright in adopt­ ing this analysis or explaining it to consumers.24 (2) nearly twenty years ago, mark hall, a leading health law and policy commentator, noted that"[ c ]ost containment pressures will not relent until phy­ sicians have undergone a revolutionary change in behavior.'.25 changes in the health care environment, mostly from then-recently adopted prospective pay­ ment by medicare ("drgs"), created cost-based pressures on hospitals to man­ age within specified financial parameters. 26 however, while financial incentives such as prospective payment for hospitals create incentives for fiscal restraint and oversight, such payment-oriented initiatives often overlook the institutional and regulatory setting in which the incentives must be imple­ mented. thus, cost-containment efforts such as prospective payment approaches are premised on an assumption that, through management intervention of some type, expensive physician behavior will change substantially. 27 this is the typi­ cal assumption of economically-focused, incentives-based interventionsthat when incentives change, behavior changes. but, this general assumption, while often correct, can lead to unforeseen or unwanted consequences. if incentives are structured inappropriately, competition can have perverse consequences. 28 therefore, attentiveness to institutional structure and design is critical in deter­ mining whether the outcomes that result from changed incentives are construc­ tive or counter-productive. in the hospital context, hall demonstrated that traditional professional au­ thority was reinforced by a "strong legal infrastructure" that created headwinds for management implementation of or inducement of changed physician behav24 for a graphical depiction of the distinction between waste control and cost control, see id at 17. in 2004, tennessee adopted a statutory definition of medical necessity in its tenncare program (a medicaid demonstration) that expressly includes economic factors in the determina­ tion of medical necessity and therefore in the scope of a beneficiary's entitlement to coverage. to qualify as medically necessmy, a diagnosis or treatment (among other things) must be the "least costly alternative course of diagnosis or treatment that is adequate for the medical condi­ tion of the enrollee." tenn. code ann.§ 71-5-144(b)(3) (2004). 25 hall, institutional control of physician behavior, supra note 22. 26 under the medicare prospective payment system for inpatient care, a hospital is paid a certain sum for a patient's hospital stay based on a diagnostic categorya diagnosis-related group ("drg"). in general, hospitals are at risk financially if the expenses associated with a hospital stay exceed the sum set prospectively by medicare for the drg. 27 hall, institutional control of physician behavior, supra note 22, at 448. 28 for a discussion of this issue, see blumstein, competing visions, supra note 7, at 1494-95 & n.174. 2007] of doctors and hospitals: setijng the analytical framework 217 ior. the legal infrastructure insulated physicians from traditional management command-and-control techniques; in place of such direct controls, hospital managers were typically left with coax-and-cajole strategies, which made it par­ ticularly difficult for managers to effectuate counter-cultural behavior change in a professional setting. 29 in the hospital setting, the organizational structure of the hospital, particu­ larly the separate medical staff, supports and insulates professional autonomy of physicians who practice at a hospital. 30 a hospital's structure makes the initia­ tion by management ofbehavioral change strategies of the medical staff a chal­ lenge for management and difficult to implement in a direct, authoritative way. the indirect management techniques characteristic of management of profes­ sionals are best suited to behavioral change consistent with the cultural norms of a profession. in the hospital management context, that means that quality improvement strategies, which are consistent with physicians' cultural norms, are likely to meet less resistance than cost-containment strategies, which tend to cut across the physicians' cultural grain. the introduction of economic consid­ erations (e.g., cost contairiment) might well require structural changes in the institutional organization or design of the hospital, or both, which would better align the financial interests of the hospital and its physician staff. because of the primacy of the hospital in the health care arena at the time, hall contended that the rigid, one-size-fits-all structure of the hospital had to be addressed if cost-containment initiatives were to succeed. hall observed a "critical need to integrate" the physician staff and hospital management ''to bring physicians within the institution's economic framework."31 absent change, the prospective payment system potentially posed an "explosive" prob­ lem because physicians and hospitals faced "diametrically opposed incen­ tives.'m that is, physicians faced unconstrained fee-for-service incentives to 29 the cultures of physicians and hospital administrators often clash. see donald e. l. johnson, medical group cultures pose big challenges, healmcare strategic mgmr, nov. 1997, at 2. unlike managers, physicians tend to be narrowly focused on individual patients, view resources as unlimited (or should be), and have a highly developed professional identity. stephenm. shortell, effectivehospitairphysicjanr.elationsfdps 12 (1991). for a skepti­ cal discussion of the effect of financial incentives in clinical decision-making, see david m. frankford, managing medical clinicians' work through the use of financial incentives, 29 wake forest l. rev. 71, 79-83 (1994)( discussing the belief structure that underlies physi­ cians' ways of thinking about medical care). coax-and-cajole techniques are likely to be more effective in bringing about changes in behavior in the name of quality assurance because quality of care (unlike cost containment) is consistent with traditional physician cultural mores. see donaidm.berwicketal.,curingheal1hcare164(1990)(suggestingtheuseofphysician leadership, training, and education to bring about improved quality through coax-and-cajole not command-and-control techniques). 30 maintenance of professional autonomy is a critical traditional value for physicians. see stephenm. shortell et al., remaking healmcarein america 105-09 (1996); blum­ stein & sloan, supra note 9, at 22-24. 31 hall, institutional control of physician behavior, supra note 22, at 505. 32 id. at 507. 218 indiana health law review [vol. 4:209 use resources, while hospitals increasingly were "subject to fiscal restraint" through prospective payment, which placed hospitals at risk financially.33 for hall, through some form of integration of the physician staff and hospital man­ agement, the ·~profession's grip on the internal organization of hospitals must be broken in order for cost containment to succeed.'.34 idns and physician-hospital joint ventures must be seen in light ofhall's prediction. the struggle for primacy in these evolving organizations is a mani­ festation of the ongoing struggle for dominance in medical care decision mak­ ing. an important issue is whether the organizational structure and control reflected in hospitals will be reproduced or varied in the evolving institutional and organizational environment in which the regulatory structure does not command a predetermined outcome of the struggle. (3) ten years ago, economist jamie robinson noted that organizational form should be seen as the "outcome of a competitive process in which particular forms survive" where they best perform the functions that need to be per­ formed. 35 robinson viewed joint ventures between hospitals and physicians as having certain "advantages of coordination without the disadvantages of bu­ reaucratization.'.36 stephen shortell, a commentator on robinson's article, recognized the advantages of institutional flexibility associated with specific organizational forms, but cautioned against "either-or'' thinking that would em­ bed a new institutional rigidity by creating "boxes of 'ideal types. ,,37 shortell recommended maintenance of institutional flexibility and pluralism in institu­ tional design. as it has turned out, shortell had good foresight. the idns of today come in many sizes, shapes, and structures. a critical benefit, which facilitates this type of pluralism in organizational form and design, is the lack of rigidity of organizational structure of the type that is imposed on hospitals by an en­ trenched and somewhat inflexible regulatory regime. 38 after two decades of 33 id. 34 i d. this is the vision of the economist use financial incentives to effect cultural change'""" but experts who study organizations and their structure tend to be pessimistic about the prospects for such substantial changes, especially among professionals such as physicians. harrison trice & janice m. beyer, the cultures of work organizations 187 (1993); john g. day, managed care and the medical profession: old issues and old tensions the building blocks of tomorrow's health care delivery and financing system, 3 conn. ins. lj. 1, 12 (1996); frankford, supra note 29, at 80. 35 james c. robinson, physicianhospital integration and the economic theory of the firm, 54 med. care res. rev. 3, 12 (1997). 36 id. at 21. 37 stephen m. shortell. commentary, 54 med. care res. rev. 25, 30 (1997). 38 the rigidity in hospital organization and structure stems from accreditation standards ofthe joint commission (formerly known as the joint commission on accreditation ofhealth 2007] of doctors and hospitals: setting me analytical framework 219 integrated models of medical care, with physician-hospital joint ventures being significant examples, 39 experience suggests that the regulatory regime should, following the recommendation of shortell, maintain institutional pluralism. no single model of organizational form or design should be locked in from a regu­ latory perspective, contrary to the approach that has been followed with respect to hospital structure and governance. the objective of regulatory policy in this ·field should be the promotion of regulatory flexibility and neutrality-a regula­ tory regime that focuses on results and outcomes, not on structure or govern­ ance. the gainsharing demonstration, planned to commence in 2007,40 should provide a vehicle for evaluating the benefits and identifying the risks of physi­ cian-hospital models of integration. 41 it also should suggest approaches for re­ vising existing regulatory pitfalls that can confront physician-hospital relationships. the challenges raised by the federal anti-kickback law will likely be a central focus of the regulatory component of the demonstration. the ex­ traordinary breadth of that statute, which prohibits the knowing and willful use of remuneration (conceived ofbroadly) to induce or solicit referrals, has placed limits on some potentially promising uses of gainsharing and can serve as a trip wire for institutional arrangements that constitute technical violations. how­ ever, the anti-kickback law itself contains two important self-corrective mecha­ nisms that can allow regulatory accommodation without the need for legislative reformregulatory safe harbors that can immunize constructive behavior that might otherwise run afoul of the broad proscriptions of the anti-kickback law, and advisory opinions, which are essentially case-specific safe harbors and which are legally binding in authorizing certain arrangements despite potential violations of the anti-kickback rules.42 iii. ways of thinking about medical care: the different models as already alluded to in the first two parts of this article, there are several different approaches to thinking about medical care and their implications for public policy analysis. specifically, these approaches include the profes­ sional/scientific model and the market-oriented model. at the threshold, how­ ever, it is important to recognize that these models are not intended to be exclusive or preclusive categories. rather, elements of both models must exist side-by-side in the health care arena. the critical question for public policy is care organizations), state licensure laws, and medicare regulations. for a discussion of these regulatory rigidities, see blum, supra note 12, at 461-64. 39 for a typology of organizational forms, see carl h. hitchner et al., supra note 12. 40 see supra note 14 and accompanying text. 41 see gail r. wilensky et al., gain sharing: a good concept getting a bad name?, 26 healthaff. 58 (2007); see supra notes 12-13 and accompanying text. 42 see clark c. havighurst et al., health care law and poucy 462-63 (2d ed. 1998); blumstein, speakeasy, supra note 11; james f. blumstein, what precisely is "fraud" in the health care industry?, wall st. j., dec. 8, 1997, at a25. 220 indiana heal1h law review [vol. 4:209 where to place the emphasis in any given set of circumstances to determine where along a continuum public policy should be directed. a. the professional/scientific model: its assumptions and implications the professional/scientific model reflects a response to perceived market failure.43 it assumes a lack ofknowledge on the part of patient-consumers and the scientific expertise of physiciansan asymmetry of infonnation.44 patients are not knowledgeable and presumably incapable ofbecoming sufficiently in­ formed so as to function as knowledgeable consumers in the medical care mar­ ketplace. in the face of consumer ignorance, the market cannot function well in the medical care arena. the implication of this perception of market failure is that decision mak­ ers other than patients must be relied on. that is, professional providers, such as physicians, serve as substitute decision makers, displacing consumers. this vests tremendous authority in professionals, based on their scientific expertise, to make decisions that have not only scientific but also economic consequences. as substitute decision makers applying professionally-developed norms and practice standards, physicians under the professional/scientific model ultimately determine individual levels of quality and the volume of services for individuals (and ultimately aggregate levels of utilization and costs). the professional/scientific model further assumes that diagnosis and treatment decisions are not influenced by financial incentives. instead, such decisions are scientifically determined and are unrelated (or only marginally related) to financial incentives, as one would expect to be the case in a market­ driven scenario. at one time, the claim that financial incentives do not matter was an empirical one. in the last thirty years, however, analysts now realize that economic incentives shape individual and patient decision making and in­ fluence the levels of utilization as well as the location in which care is provided (e.g., inpatient vs. outpatient). the claim that financial incentives do not matter now rings more of a normative than an empirical bell; that is, consideration of economics is, or runs the risk ofbeing, corrosive to medical practice and there­ fore is inappropriate. b. the market-oriented model: its assumptions and implications the market-oriented response to market failure that stems from lack of 43 see paul starr, the social transformation of american medicine 226-27 (1982) (arguing that the professional/scientific model was not solely a response to market failure but a contributor to market failure in the service of professional dominance). 44 see kenneth j. arrow, uncertainty and the welfare economics of medical care, 53 am. econ. rev. 941 (1963), reprinted in 26 j. healmpol. pol'y & l. 851, 871-72 (2001) (identifying market failure in medical care and attributing it, in part, to an asymmetry of infor­ mation between patients and physicians). 2007] of doctors and hospitals: setting the analytical framework 221 consumer knowledge is to provide information and education. the objective of public policy under this view is to improve the flow of comprehensible infor­ mation to consumers so that they can function better as consumers. one way to achieve this goal would be through the use of information intermediaries to help consumers understand and process unfamiliar information. the market-oriented approach normatively relies on the importance of pa­ tient autonomy the traditional authority of patients to understand the issues surrounding and to give consent to medical interventions. 45 the impetus for more involvement of patients in their own care responds, at least in part, to a bottom-up concern with patient empowerment. 46 the market-oriented approach also has gained momentum from patients who have shown a remarkable ability to learn about their own (often life-threatening) illnesses and, newly knowl­ edgeable, are eager to participate with their physicians in decision making about their medical situations. expanded information flow to patients has been stimulated by the emer­ gence of patient-centered rules of disclosure under the doctrine of informed consent.47 the internet and other technological advancements have led to the burgeoning of accessible, comprehensible information, which has resulted in the emergence of a more knowledgeable (and, therefore, empowered) patient. such patient empowerment is manifested in the shared decision making move­ ment, which is characterized by physicians and patients sharing more even­ handedly in a patient's medical diagnosis and treatment. these conversations between physicians and patients include medical and other (e.g., lifestyle and economic) factors that often inhere in a course of diagnosis and/or treatment. 48 furthermore, evidence suggests that patients who participate in their own medi­ cal care decision making are more likely to adhere to appropriate courses of treatment.49 an important goal for advocates of a more market-oriented approach in health care is to develop an industry structured so that incentives are proper and private decision makers make both self-interested and socially appropriate deci­ sions. 45 "common law principles recognize personal autonomy by requiring consent before a physician is authorized to touch a patient. ..• to be effective. consent must be 'informed'." blumstein, competing visions, supra note 7, at 1474. for a discussion of the informed consent doctrine, see peter h. schuck, rethinking lliformed consent, 103 yale l. j. 899 (1994). 46 see blumstein, competing visions, supra note 7, at 1475 & n.66. 47 see id. at 1474-75 (discussing the doctrine of informed consent as an inroad on the traditional professional/scientific paradigm). 48 see, e.g., joseph f. kasper et al., developing shared decision-making programs to lmprovethequalityofhealth care,l8 quainyrev.buil.l83 (june l992)(discussingrisks of prostate surgery and choices of men about surgical and non-surgical treatment alternatives). 49 blumstein, competing visions, supra note 7, at 1475. 222 indiana health law review n. the hospital as the embodiment of the professional/scientific model [vol. 4:209 the organization and structure ofthe modem american hospital are dri­ ven by a regulatory regime that requires the existence of a separate medical staff within the hospital. 5° the separation between general administrative gov­ ernance and medical staff governance within the hospital is a tool to ensure that professional autonomy in medical decision making will be free from lay influ­ ence or control 51 and has a rationale akin to that of the traditional doctrine that banned or restricted the corporate practice of medicine. 52 that is, physicians must be solely responsible for making scientifically-determined medical judg­ ments without interference with those decisions by hospital administrative offi.., cials.53 in some jurisdictions, the medical staffbylaws constitute binding and enforceable contractual obligations, which limit the authority of the hospital to make decisions about appointing or retaining its medical staff. 54 the assumption underlying the regulatory-imposed hospital structure is well illustrated by muse v. charter hospital of winston-salem, inc. 55 muse 50 see blum, supra note 12, at 461-64; hall, institutional control of physician behavior, supra note 22, at 528-32 (providing a good background on the topic). the hospital structure has been referred to as "tripartite" because it contemplates a "board, medical staff, and administra­ tion." blum, supra note 12, at 460. this structure is not happenstance but instead imposed by a universal regulatory regime that includes state licensure law, medicare, and accreditation stan­ dards adopted and implemented by the joint commission. id. at 461-63. 51 see blumstein & sloan, supra note 9, at l 0-12 (discussing the historical evolution of the separate medical staff in the hospital setting). 52 see arnold rosoff, the business of medicine: problems with the corporate practice doctrine, 17 cumb. l. rev. 485 ( 1987); jeffrey f. chase-lubitz, note, the corporate practice of medicine doctrine: an anachronism in the modern health care industry, 40 v and. l. rev. 445 (1987) (discussing the corporate practice of medicine doctrine). the corporate practice doctrine "prohibits corporations from providing professional medical services" and "is primarily inferred from state medical licensure acts, which regulate the profession of medicine and forbid its practice by unlicensed individuals." berlin v. sarah bush lincoln health ctr., 688 n.e.2d 106, 110 (ill. 1997). one important underlying public policy concern is the "danger[] oflay control over professional judgment." jd. 53 see beverly cohen, an examination of the right of hospitals to engage in economic credentialing, 77 temp. l. .rev. 705 (2004) (discussing the question of whether hospitals can make credentialing decisions on a basis other than professional competence). the joint com­ mission accreditation manual describes credentialing as follows: "credentialing involves the collection, verification, and assessment of information regarding three critical parameters: cur­ rent licensure; education and relevant training; and experience, ability, and current competence to perform the requested privilege(s)." the joint commission, 2007 comprehensne accreditation manual for hospitals: the official handbook ms-15 (2007). although these terms do not necessarily preclude the use of economic factors, they also do not explicitly include them. !d. 54 lewisburg cmty. hosp., inc. v. alfredson, 805 s.w.2d 756, 759 (tenn. 1991); but see mason v. cent. suffolk hosp., 819 n.e.2d 1029, 1030 (n.y. 2004). 55 muse v. charter hosp. ofwinston-salem, inc., 452 s.e.2d 589 (n.c. ct. app. 1995), 2007] of doctors and hospitals: setting the analytical framework 223 involved a mental health patient with thirty days of inpatient insurance cover­ age. 56 as the thirty days wound down, the hospital engaged in a process of dis­ charge planning, leading to the patient's discharge to a public mental health authority for outpatient treatment. 57 under conventional doctrine, hospitals are not permitted to abandon pa­ tients, but they may transfer patients to other suitable facilities. the question is whether the alternative facility is suitable to the needs of the patient. 58 under the conventional doctrine, the abandonment inquiry in muse would have fo­ cused on the suitability of the public mental health outpatient service to which the patient had been discharged. instead, the court used a different analysis and held that a "hospital has the duty not to institute policies or practices which in­ terfere with the doctor's medical judgment. "59 although the doctor signed the patient's discharge papers, the hospital was found liable for wanton and willful conduct since it adopted a policy of discharge planning that seemed to the court to require patient discharge upon the expiration of the patient's insurance cov­ erage.60 since the physician actually discharged the patient, the hospital was liable because it adopted a policy or practice that "interfered with the medical judgment" of the patient's attending physician.61 one interpretation of what it meant for the hospital to "interfere" with the physician's medical judgment was that the hospital expected the physician to include in his decision making the consideration of the economic reality that the patient's insurance coverage was about to (and did) expire. the organization and structure of the hospital, therefore, seem to reflect an assumed need to insulate the members of the physician staff from the con­ sideration of cost and other non-medical factors in their decision making. muse shows a very low threshold for concluding that professional medical judgment is corrupted encompassing, in the muse case at least, the possibility that any consideration of economic factors in a physician's decision making process is an impermissible corruption of professional medical judgment. the organization and structure of the hospital bear a certain resemblance to the structure of a university in which members of the faculty are autonomous on matters of educational decision making and protected under the norm of academic freedom from inappropriate administrative oversight. the separate medical staff contemplates a model of governance in which physicians enjoy medical governance prerogatives akin to the academic freedom of university faculty. this structure suggests very limited control by hospital administration and is consistent with viewing hospitals as a physicians' workshop. this tradi­ tional ''workshop" vision of the hospital can be referred to as an ebay model of affd per curiam, 464 s.e.2d 44 (n.c. sup. ct. 1996). 56 !d., 452 s.e.2d at 593. 57 !d. 58 see payton v. weaver, 182 cal. rptr. 225 (1982). 59 muse, 452 s.e.2d at 594. 60 /d. 61 /d. 224 indiana health law review [vol. 4:209 hospital governance and function. in this vision, hospitals are not seen as having independent institutional interests; they are locations or forums in which patients receive care and physi­ cians practice their profession. this structure, however, raises questions about routine management decisions that can affect the institutional interest of a hos­ pital. for example, hospitals may seek to contract selectively or exclusively with certain physicians or physician groups for a variety of institutional reasons related to cost and/or quality issues. this raises the issue of economic creden­ tialingcan hospitals base staff decisions on criteria other than physician com­ petence?62 the question of economic credentialing demonstrates the tension between the traditional "workshop" or ebay vision of the hospital and the emerging real­ ity that hospitals have their own institutional interests that need to be addressed and accommodated. once it is recognized and acknowledged that hospitals have their own institutional interests, it becomes axiomatic that they will need to develop mechanisms by which they can attend to those interests.63 physi­ cians practicing within a hospital have a strong influence on the hospital's insti­ tutional interests related to such issues as medical errors, overall quality of care (and attendant concerns about reputation and liability), and cost of care (with hospitals often fmancially at risk for consistently above-average costs of ser­ vices). under such circumstances, it is important that medical practice in hos­ pitals be brought in from the economic cold. since hospitals have their own institutional interests, it is no longer desirable or probably even viable for medi­ cal practice within a hospital to remain outside the economics of the hospital or outside the authority structure of the management of the hospital. 64 in a world where organizational form is the "outcome of a competitive process in which particular forms survive" because they best perform the func­ tions that need to be performed, 65 it is not surprising that hospitals would seek to develop and embrace organizational forms and structures that better accom­ modate their own institutional interests and objectives. the built-in rigidity of 62 see cohen, supra note 53, for a discussion of economic credentialing. 63 see blumstein & sloan, supra note 9, at 91, for an interesting discussion ofhow anti­ trust law can help to encourage hospital decision making more nearly to reflect the "mode of decisionmaking of more traditional economic entities such as firms." blumstein and sloan ar­ gue that "historically entrenched attitudes, professional prerogatives, economic dependence, institutional structural rigidities, and legal doctrines have created headwinds against the kind of hospital role" in which hospitals "will generally act in accordance with consumer interests to the extent that the external environment permits." !d. they advocate use of antitrust doctrine more aggressively "in compelling hospitals to act more like competitive economic entities." !d. concentrating on ''the most risky areasphysician cartel behavior," they recommend that "hos­ pitals shoulder the burden of demonstrating the procompetitive character of decisions that, based on history and the insights of social science research, one can reasonably label prima facie anti­ competitive." !d. 64 see hall, institutional control of physician behavior, supra note 22, at 507. 65 robinson, supra note 35, at 21. 2007] of doctors and hospitals: setting the analytical framework 225 the regulatory regime governing hospitals predictably led to the pursuit of other mechanisms that better perform certain functions that need to be performed. this might include bringing economic and other non-medical factors into the decision making process and seeking greater hospital authority to assert quality­ enhancement and cost-containment objectives. v. the evolving external environment and its impact a conclusion in part iv was that the traditional "workshop" or ebaymod­ el of the hospital is no longer appropriate because hospitals increasingly have independent institutional interests that need to be addressed and accommo­ dated. this part will identify and explain two of the most significant external factors that have led to the evolution of these independent institutional interests of hospitals. a. quality of care the first factor is a hospital's interest in promoting and managing the quality of care, including medical errors, that is provided in the hospital. this interest has both a positive and a negative component. the positive component concerns a hospital's desire to promote its own reputation for quality and for managing effectively to assure quality66 in a mar­ ket-driven, competitive environment.67 to achieve this objective, hospitals have an incentive to seek out organizational structures that allow hospital man­ agement more directly to design and implement quality-enhancement strategies that are consistent with the hospital's interest in promoting its reputation for quality. pursuit of this institutional objective is particularly appropriate in light of the revelation by the institute of medicine of the degree to which medical errors occur in hospitals and of the systemic nature of those errors, 68 which not only lend themselves to an institutionally-oriented response but require it.69 the negative component of a hospital's interest in quality of care is that hospitals are increasingly responsible from a liability perspective for medical 66 see william m. sage & peter j. hammer, a copernican view of health care anti­ trust, law & contemp. probs., autumn 2002, at 241, 252-53, for a discussion of the hospital's interest in promoting quality for its own institutional, competitive reasons in a managed care setting. 67 see thomas e. kauper, the role of quality of health care considerations in anti­ trust analysis, law & contemp. probs., spring 1988, at 273, for a discussion of the pro­ competitive aspects of promoting health care quality in a competitive, market-based environ­ ment. 68 see lnst. of med., to err is human: building a safer health system (1999). 69 see james f. blumstein, the legal liability regime: how well is it doing in assur­ ing quality, accounting for costs, and coping with an evolving reality in the health care marketplace?, 11 annals realm l. 125 (2002), for a discussion of the liability implications of the iom findings. 226 indiana realm law review [vol. 4:209 mal-occurrences that transpire within their four walls. the hospital's liability risk has grown along two related but distinct pathways direct and vicarious liability. increasingly, there is a recognition that hospitals have a direct duty to their patients in the following four areas: (i) to maintain safe and adequate facilities and equipment; (ii) "to select and retain only competent physicians;" (iii) to oversee all persons who practice medicine and provide patient care within their walls; and (iv) to formulate, adopt, and enforce rules and policies to ensure quality of care for patients.70 the breach of a direct duty to a patient can result in liability. clearly, the hospital's direct duty to assure the provision of quality care to patients being treated within its walls places a managerial responsibility on the hospital as an institution. in turn, such responsibility leads hospital ad­ ministrators to be concerned about how to implement that responsibility and to ensure compliance given the governance structure ofhospitals. for example, the separate medical staff structure provides hospital managers with limited direct authority with respect to the selection or retention of physicians, even though the hospital incurs liability for a failure to select and retain only compe­ tent physicians. 71 in sum, even though hospitals are typically left to manage by coax-and-cajole, not command-and-control, they are responsible, nevertheless, for assuring the non-negligent provision of quality care for patients. hospitals also have faced vicarious liability for negligence in patient care. for employees (e.g., physicians and nurses), the traditional doctrine of respon­ deat superior has been applied to hospitals. 72 in the hospital setting, even though most physicians with practice privileges are not hospital employees, courts increasingly have imposed vicarious liability on hospitals under princi­ ples of ostensible agency.73 under ostensible agency doctrine, a principal should be held liable for the negligent conduct of its agent if the person dealing with the agent had a reasonable belief (for which the principal can be held ac­ countable) that the agent was authorized to act for its principal. 74 70 see, e.g., thompson v. nason hosp., 591 a.2d 703,707 (pa. 1991) (describing the hospital's duties). see generally sword v. nk.c hosp., inc., 714 n.e.2d 142 (ind. 1999) (adopting corporate negligence standard for hospital liability). 71 see elam v. college park hosp., 183 cal. rptr. 156, 162-64 (ct. app. 1982) (recog­ nizing that although peer reviews for quality purposes are conducted by the independent medical staff, the hospital itself is ultimately responsible for assuring quality and failure in that process leads to liability under the doctrine of corporate negligence). 72 see, e.g., mcdonald v. hampton training sch. for nurses, 486 s.e.2d 299 (va. 1997) (finding hospital liable for negligence of physician when physician is an employee of the hospi­ tal); bernardi v. cmty. hosp. ass'n, 443 p.2d 708,713 (colo. 1968) (applying respondeat supe­ rior principles to hospital liability for negligence of nurse employee). 73 see, e.g., grewe v. mount clemens gen. hosp., 273 n.w.2d 429, 434-35 (mich. 1978). 74 see, e.g., id at 434. under grewe, a plaintiff is obligated to establish (1) the patient had a reasonable belief in the agent's authority; (2) the patient's belief was generated by an act or the neglect of the hospital; and {3) the patient is not negligentthat is, the patient reasonably 2007] of doctors and hospitals: setiing the analytical framework 227 one troubling concern with imputation ofliability under ostensible agen­ cy is that the doctrine focuses analytically (in substantial part) (a) on the rea­ sonableness of the patient's belief that the physician was the agent of the hospital and (b) on the conduct of the hospital in creating, reinforcing, or dis­ abusing patients of that perception. the questions of patient perception and the reasonableness ofthe hospital's conduct in either reinforcing or offsetting that perception may not address the real underlying concern finding a satisfying doctrinal substitute for respondeat superior in the absence of an employer­ employee relationship. there is a considerable question as to whether the ap­ plication of the ostensible agency doctrine in the hospital context has intellec­ tual integrity or whether it is an intellectual halfway house. to have doctrinal integrity, the ostensible agency doctrine must allow a hospital to defend against liability by successfully challenging the reasonable­ ness of a patient's belief that a physician is an agent of the hospital. yet in grewe, an ostensible agency case, the michigan supreme court left open the question of what the result would be "if plaintiff knew or should have known" that the relationship of the physician and the hospital was not that of agent and principal.75 given the nature of the doctrine and the elements of the doctrine, it is startling to have the grewe court leave that issue open. other courts applying ostensible agency or a variant (agency by estoppel)76, however, have declined to give effect to obvious notices placed in an emergency room for the purpose of notifying the patient that the physicians practicing in the emergency room were independent contractors and not employees of the hospital.17 this type ofhold­ ing, which seems to challenge the doctrinal core of ostensible agency, 78 calls into question the integrity and viability of the doctrine in the hospital setting. the doctrinal inadequacies of ostensible agency have led some courts to look for a more satisfying doctrineone imposing on hospitals a non-delegable duty to assure non-negligent patient care within the hospital. some courts have been reluctant to embrace the concept, 79 and even when embracing the concept in the context of an emergency room, courts accepting the doctrine have modi­ fied it. for example, in simmons v. tuomey regional medical center, south carolina purported to accept the non-delegation principle, imposing a non­ delegable duty on hospitals to ensure the rendering of competent service to pa­ tients in the emergency room setting. 80 the simmons court was critical of osrelied on his or her perception of the physician as the agent of the hospital. id. 75 id. at 435. 76 see baptist mem'l hosp. sys. v. sampson, 969 s.w.2d 945,947 n.2 (tx. 1998) (not­ ing that "[m]any courts use the terms ostensible agency, apparent agency, apparent authority, and agency by estoppel interchangeably" and that, "[a)s a practical matter, there is no distinction among them."). 77 clark v. southview hosp. & family health ctr., 628 n.e.2d 47,54 (ohio 1994). 78 see baptist mem 'l hosp. ~s., 969 s.w.2d at 950, for an example of a court giving effect under ostensible agency to hospital signage that informed emergency room patients of the physician-hospital relationship. 79 see, e.g., id. at 948-49. 80 simmons v. tuomey reg'l med. ctr., 533 s.e.2d 312, 322 (s.c. 2000). 228 indiana health law review [vol. 4:209 tensible agency as a rationale for hospital liability because (i) it believed that requiring a finding that the hospital acted culpably in representing that it was the principal and the physicians were its agents was inappropriate and unneces­ sary and (ii) it believed that proof of the patient's reliance on the hospital's rep­ resentation was also inappropriate and unnecessary.81 accordingly, the court imposed, as a matter of policy, a non-delegable duty on hospitals to render com­ petent care to patients in its emergency room. 82 in describing the nature of the non-delegable duty, however, the simmons court reintroduced many of the ele­ ments of ostensible agency such as the reasonableness of the patient's belief that the physician was a hospital employee. 83 while the courts still struggle with the appropriate doctrinal formula for vicarious liability, the fact remains that courts have expanded hospitals' liability for the medical maloccurrences of their physicians and other medical care pro­ viders. hospitals, regardless of whether they are positively seeking to advance quality as a reputation-based marketing plus or negatively concerned about the liability risks of poor quality and high error rates, are confronted with a situa­ tion in which hospital management needs to address and accommodate ration­ ally the hospitals' own institutional interests. to the extent that the existing hospital organization and governance structure is not conducive to the pursuit of hospitals' own institutional interests regarding quality assurance, they are predictably going to seek out alternative arrangements and institutional struc­ tures that allow more direct hands-on management of the hospital for the achievement of quality of care objectives. b. cost containment the hospital's structure makes the introduction of economic considera­ tions difficult. as noted previously, the hospital's structure is reflective of the professional/scientific model in which economic considerations are marginal­ ized. 84 the structure of the hospital assumes that medical decision making is largely technical, exclusively a matter of scientific expertise, and entirely within the sphere of autonomous physician control. this rigid one-size-fits-all struc­ ture is an impediment to effective cost-containment initiatives implemented by hospitals. because cost containment is counter-cultural for physicians, and be­ cause the hospital governance structure compels reliance on coax-and-cajole techniques rather than command-and-control techniques of management, achieving hospitals' institutional cost containment objectives is even more of a challenge than achieving a hospital's quality of care objectives.85 81 see id. at 320-21. 82 /d. at 322. 83 id at323. 84 see supra parts lli.a, n. 85 see frankford, supra note 29; jonathan j. frankel, note, medical malpractice law and health care cost containment: lessons for reformers from the clash of cultures, i 03 2007] of doctors and hospitals: seti'jngtheanalyticalframework 229 yet, for hospitals, addressing and coping with cost containment pressures have become more acute concerns. in his work on hospitals and cost contain­ ment, mark hall noted a "critical need to integrate" the physician staff and hos­ pital management "to bring physicians within the institution's economic framework."86 he also noted, however, the institutional constraints that im­ peded that development. 87 the shift in the way hospitals are paidby medicare and some private in­ surance carriers has resulted in hospitals being expected to assume financial risk that they had not previously been expected to absorb. previously, hospitals had been paid on a retrospective reimbursement basis, premised on cost reim­ bursement. if patients have insurance in such an environment, hospital finance is relatively straightforward. hospitals spend money on patient care, and insur­ ance carriers reimburse those expenditures. in such circumstances, hospitals have no substantial independent financial interests; they are not at risk fman­ cially. when medicare adopted a prospective payment system for inpatient hos­ pital services in the 1980s, however, hospitals were expected to operate within preset fiscal parameters. if they did not manage their costs, they could no long­ er seek after-the-fact reimbursement for excess costs as they had done in the past. instead, hospitals' revenues were limited to the amount of the prospective payment set by medicare. a similar dynamic resulted from private insurers and health plans, which placed financial limits on hospitals through discounted pric­ ing or capitation payment approaches. these tighter fiscal constraints imposed independent financial interests on hospitals, but the traditional hospital organ­ izational and governance structure was premised on a model that assumed away the significance and even the legitimacy of cost considerations in medical care decision making. the evolution of the health care marketplace allowed hospitals to pursue different roles, providing an opportunity for hospitals to reverse, to some extent, the power relationships with doctors for example, by bidding for managed care contracts with health plans, thereby securing control of patient flow and channeling patients to physicians. the market and the confining structure of the hospital provided an incentive and an opportunity for hospitals to break out of the traditional ''workshop" type of physician-hospital relationship. some­ times, hospitals have incentives to cooperate with physicians, and sometimes they prefer strategically to compete with physicians. these new relationships, however, are occurring outside the traditional hospital-physician relationship structure. the various models of physician-hospital relationships emerged in re­ sponse to the reality that medical care is functioning in a market-based enviyale l.j. 1297 ( 1994), for a discussion of the problem of cost containment from the perspective of a hostile physician culture. 86 hall, institutional control of physician behavior, supra note 22, at 505. 87 !d. at 505-07. 230 indiana heal'ih law review [vol. 4:209 ronment. they reflect a shift towards greater recognition and acceptance of market-based assumptions and realities. the traditional confining hospital structure was crafted under the controlling assumptions of the profes­ sionavscientific paradigm. the newer and still-emerging physician-hospital relationships that are developing outside the traditional hospital structure are entities and relationships that are premised on market-oriented principles and adaptive to the emergence of and legitimation of the market-oriented paradigm. idn s, therefore, cannot be understood outside the need for physicians and hos­ pitals to develop new structures to manage costs and promote quality (as good business practices). vi. the evolution of integrated delnery networks as the above theoretical discussion suggests, there appears to be a con­ sensus among empirical scholars who have studied the matter that physician­ hospital integration "reflects providers' organizational responses to competitive pressures from rapidly expanding managed care health insurance.'.s8 that is, idns reflect the influence of and are a response to the emergence of the market model. they reflect no single prototype and can be led by hospitals or by phy­ sician groups. 89 a. competing hypotheses and rationales the question has arisen as to the likely consequences of hospital­ physician integration. is such integration likely to result in efficiency gains? that is, do the more efficient integrated organizations offer lower prices to ma­ naged care plans through lower levels of utilization or other efficiencies in the production of medical care services? or, alternatively, is integration really an attempt by providers to improve bargaining power (through enhanced market power) with managed care plans? such a story would suggest increased prices instead of lower prices90 and would also suggest that the idns were not de­ signed or used for a fundamental restructuring of the physician dominance that characterized the traditional hospital structure and that had stemmed from a non-market-based premise. 88 allison evans cuellar & paul j. gertler, strategic integration of hospitals and physi­ cians, 25 j. heai.:rnecon. 1, 1 (2006). 89 for typologies of various forms ofidns, see id. at 8-11; hitchner et al., supra note 12. 90 this market-power scenario was a concern expressed by the recent report of the u.s. department of justice and the federal trade commission. fed. trade comm'n & dep't of justice, improving health care: a dose of competition 13 (2004) (executive summary). 2007] of doctors and hospitals: setting the analytical framework 231 b. the evidence although the evidence is not uniform on the issues,91 there is considerable evidence that hospitals with an integrated organizational structure do not have lower costs than unintegrated hospitals.92 hospital-physician integration seems to be a "strategic response to counter the rising monopsony power of managed care and is one of the sources of the recent increase in health care costs."93 that is, much evidence seems to support the market-power explanation of ions, not the true efficiency explanation. 94 ions, in general, seem not to have been vehicles through which hospitals have asserted authority or developed pathways around traditional medical staff relationships to introduce cost­ containment measures. "[i]ntegrated organizations have higher prices than stand-alone hospitals," with greater effects on exclusive arrangements and in less competitive markets. 95 in addition, at least in some studied areas, proce­ dure rates seem to increase for hospitals with physician-hospital arrangements. 96 the result has been that expenditures in hospitals with physician-hospital or­ ganizations ("phos") were three percent higher than expenditures of patients in non-pho hospitals.97 in a survey of evidence, lawton burns and mark pauly confirmed the conclusion that "affiliating 'or linking outpatient care with a large and complex inpatient institution tends to raise the marginal and average cost of both inpa­ tient and outpatient care."98 idns have not, in general, achieved a high level of clinical integration, which could lead to efficiencies and higher quality. over­ all, burns and pauly are pessimistic about the future ofidns, observing that "[t]he proportion of hospitals with these types of alliances peaked in 1996 and has declined ever since. "99 what conclusion, if any, can be drawn from this brief survey of evidence? it seems that idns have not fulfilled at least one aspirationmore efficient and 91 see, e.g., federico ciliberto & david dranove, the effect of physician-hospital af­ filiations on hospital prices in california, 25 j. hea.lmecon. 29, 37 (2006) (finding no evi­ dence that vertical integration resulted in higher prices in california hospitals during the 1990s ). 92 cuellar & gertler, supra note 88, at 11. 93 id. at 26. the ftc and ooj also expressed this concern in their joint report. see fed. trade comm'n & dep't of justice, supra note 90, at 13. 94 see, e.g., alfredo g. esposto, contractual integration of physician and hospital ser­ vices, 8 j. mgmt. & gov't 49 (2004) (concluding that cost-saving is not a basis for physician­ hospital integration). 95 cuellar & gertler, supra note 88, at 26. 96 see kristin madison, hospital-physician affiliations and patient treatments, expen­ ditures, and outcomes, 39 health servs. res. 257,264-66 (2004) (studying certain cardiac procedures). 97 id at272. 98 lawton r. burns & mark v. pauly, integrated delivery networks: a detour on the road to integrated health care?, healmaff •• july/aug. 2002, at 128, 130. 99 /d. 232 indiana health law review [vol. 4:209 lower cost delivery of medical care. it seems the objective that mark hall set out nearly twenty years agoto change physician behavior and to reduce phy­ sician dominance100 has not (or at least has not yet) been achieved. but ex­ cessive pessimism also seems unwarranted. from a regulatory perspective, idns are not subject to the institutional or organizational rigidity of hospitals. their organizational form can be flexible, driven by market realities, and un­ constrained by the one-size-fits-all straitjacket of the hospital regulatory struc­ ture. this presents an opportunity for entrepreneurship and responsiveness to quality and cost challenges. idns have been and are likely to remain a battle­ ground for the maintenance of physician control and dominance, in partnership with provider hospitals that apparently would rather combine than combat. hospitals have real and justified fears of alienating physicians, who are the caregivers and can influence patients. idns allow for flexible ordering of physician relationships with hospitals and other types of organizational forrn8. they may not have fulfilled the objectives that many set for them, and regula­ tory vigilance of their potential for anti competitive effects is certainly appropri­ ate. but they remain an important organizational forma potential vehicle for accommodating marketplace demands for cost sensitivity and quality assurance. the flexibility that still characterizes the regulatory regime for idns is an important plus; the strategic goal is to develop incentives appropriately so that idns can be used constructively to improve performance in containing costs and improving quality. vii. physician-hospital interaction: the future recent survey evidence indicates that hospitals are increasingly fearful of competition from physicians and concerned about threats to "long-standing col­ laborative relationships between physicians and hospitals."101 this includes a concern by hospital administrators that competition between physicians and hospitals could ''threaten physicians'long-standing orientation toward support­ ing hospitals' social missions, including caring for the uninsured."102 from the perspective ofttaditional community hospitals, physician-owned specialty hospitals and other facilities (such as laboratories) pose a competitive threat. according to a 2005 survey, this threat has increased from that per100 hall, institutional control of physician behavior, supra note 22, at 507. 101 robert a. berenson et al., hospital-physician relations: cooperation, competition, or separation?, 26 healrnaff. w31, w32 (2007). /d. 102 id. one surveyed hospital administrator expressed concern as follows: doctors used to feel that in return for having the hospital as a place to care for their patients and earn income, they should contribute to the hospital, taking ed call, participating on committees, improving quality. now they say to the hospital, screw you. . . . many don't even come to ~e hospital anymore. 2007] of doctors and hospitals: setiing tile analytical framework 233 ceived by hospital administrators in the previous 2000 survey.103 this increas­ ingly significant marketplace phenomenon has meant that hospitals face "grow­ ing competition" with physicians "over services that had once been within the hospital domain.''104 many times the hospital is competing with its own medi­ cal staff, who are "opening an ambulatory surgery center [or] diagnostic center" and "shifting ... services from hospital control to physician control."105 this has led some surveyed hospital administrators to "consider[] the competition with physicians as actually more intense than with other hospitals in the com­ munity.''106 this type of emerging competition between hospitals and physicians (in­ cluding their own medical staff) highlights the point raised earlierhospitals increasingly have their own independent institutional interests in the evolving health care marketplace. it reinforces the earlier critique of the traditional, ri­ gid, one-size-fits-all regulatory regime of the modern american hospital. that traditional regulatory structure was a product of adherence to a visionthe pro­ fessional/scientific paradigm that no longer reflects the exclusive focus and function of the modem hospital. hospitals are not merely workshops for physi­ cians and do more than provide a forum or location in which physicians provide services to ignorant patients while the hospitals have no institutional interest in or accountability for what goes on within their four walls. in response to growing physician competition, some hospitals will pursue cooperative or co-optative strategies, while others will seek to compete.107 co­ operative or co-optative hospital strategies are often driven by a" 'half a loaf is better than none"' rationale.108 facing a potential loss of revenues to a free­ standing (typically physician-owned) entity, some hospitals will form a joint venture with physicians in order "to retain some of the revenues they otherwise might lose. "109 this may be driven by the rationale ''that the collaboration will help assure continued physician referral of patients who need inpatient hospital services."110 in general, hospital officials view joint ventures of this type with physicians as "a way to reduce potential lost revenues from outmigration of ser­ vices tophysicians.''111 physicians are attracted to this type of joint venture with hospitals "be­ cause of their capital, their management experience, and the broader pool of patients that might be attracted."112 such joint ventures may also be a ''way to 103 id at 33. 104 id at 34. 105 id at 35. 106 ld. 107 ld at37. 108 id at38. 109 ld. 110 ld. 111 id. 112 id 234 indiana health law review [vol. 4:209 avoid risky, head-on competition with the hospital."113 some physicians, how­ ever, have sought to partner with independent companies that will "contribute capital and management expertise to a joint venture with a physician group."114 by forming a joint venture with an independent company, physicians are indeed engaging in direct competition with hospitals for services previously and his­ torically provided by hospitals. there is a concern that the legal regulatory regime may inhibit construc­ tive cooperative arrangements. relaxing restrictions on gainsharing might be an example of possible reform, 115 and the gainsharing demonstration should provide insight for consideration of regulatory reform in the anti-kickback and anti-self-referral arenas. 116 . hospitals that might want to compete with (rather than cooperate with or co-opt) their staff physicians have traditionally faced an uncertain regulatory landscape. more recently (as described below), courts seem to recognize that hospitals have a legitimate interest in pursuing their own independent economic interests and have allowed hospitals to pursue policies designed to compete with physicians on their medical staffs. the traditional hospital structure grants physicians control over medical staff competence through the credentialing process. the difficult issue arises when hospitals seek to incorporate criteria other than medical competence into the credentialing process. this is an understandable hospital response to com­ petition from physicians, especially those on the hospital's medical staff. as hospitals seek to compete on quality and price/cost, they seek greater control over decisions that affect their ability to manage quality and cost. ex­ clusive contracting with physicians or physician groups may be a way for hospi­ tals to impose accountability for quality assurance on the medical staff, with a contractual means ofenforcement. similarly, a hospital may seek to impose conflict-of-interest rules which, in other economic sectors, would be deemed conventional protections against the inappropriate appropriation of corporate opportunity. because physicians have significant influence on referrals, hospi­ tals may reasonably fear that physicians will direct well-insured patients to their own facilities while referring underinsured or uninsured patients to the hospitals for service. in most other sectors, such self-defensive measures would be self­ evidently rational and legitimate, but there has been tremendous controversy in the hospital sector over whether such economic credentialing is appropriate or legal. ii? 113 id 114 id at 39. 115 see, e.g., wilensky et al., supra note 41; see also medicare payment advisory comm 'n, report to congress: physician-owned specialty hospitals (2005), available at http://www.medpac.gov/publications _congressional_ reports_ mar05 _ spechospitals.pd£ see also saver, supra note 13. 116 see supra note 14. 117 for a recent consideration of these issues, see cohen, supra note 53. 2007] of doctors and hospitals: settingtiieanalyticalframework 235 recent court decisions seem to show receptivity to hospital claims in this arena. courts·appear more comfortable with hospital initiatives that focus on the institutional interest of the hospital itself. for example, in baptist health v. murphy, 118 a private nonprofit hospital excluded physicians from the medical staff if they acquired or held an ownership or investment interest in a competing hospital. the arkansas supreme court rejected a challenge to the hospital's action. 119 analogously, in city of cookeville v. humphrey, the tennessee supreme court allowed a public hospital to "close" its imaging department by entering into an exclusive contract with a radiology group.120 the hospital faced compe­ tition from a physician-owned imaging facility and was concerned about losing business to it. the physicians who owned the imaging facility were members of the medical staff at the public hospital. notably, the court held that no hear­ ing under the medical staffbylaws was necessary since the purpose of the hear­ ing procedure was to determine medical competency, and the decision to close the imaging department was based on non-medical considerations. 121 the hos­ pital's "decision to close the staff of the hnaging department is a business deci­ sion," so a "due process hearing would be purposeless."122 no hearing is required as an abstract matter, but is required if relevant facts that can lead to a finding ofliability and a remedy are placed in controversy.123 in mahan v. avera st. luke's, the south dakota supreme court similarly allowed a hospital to close its staff for certain procedures. 124 the court held that the hospital's medical staff bylaws did not apply because the hospital deci­ sion in question was "not about appointments or the assignment or curtailment of privileges."125 instead, the decision was "about an administrative decision to close [the hospital's] staff for certain procedures," so the medical staff bylaws "do not apply."126 the south dakota court was expressly solicitous of the hos­ pital's interest in establishing "clear lines of management authority'' and wor­ ried about the "confusion" that would ensue if the hospital's lay board had only 118 baptist health v. murphy, 2006 ark. lexis 58 (ark. 2006). 119 id. the arkansas supreme court rejected a claim that the hospital's conduct violated the federal anti-kickback law. had there been such a violation, the hospital's policy would have been invalid as a matter of public policy under state law. see polk county v. peters, 800 f. supp. 1451, 1456 (d. tex. 1992)(refusingto enforce a contract between a physician and a hos­ pital in a claim for damages because the contract violated federal anti-kickback law and there­ fore was unenforceable under state law as against public policy). 12° city of cookeville v. humphrey, 126 s.w.3d 897, 907 (tenn. 2004). 121 id 122 id. 123 "[d]ue process protections are not triggered when the process would not serve any useful purpose or result in a remedy." id. (citing codd v. velger, 429 u.s. 624,627 (1977)). 124 mahan v. avera st. luke's, 621 n.w.2d 150, 163 (s.d. 2001). 125 id. at 157. 126 id. 236 indianaheal1h law revmw [vol. 4:209 a "minimal amount of control over its medical staff."127 in radiation therapy oncology, p. c. v. providence hospital, 128 a private non-profit hospital's board of directors decided to establish an "integrated and unified cancer-care center where both radiation-oncology and medical-oncology services would be delivered to patients from one location. "129 this transfer re• sulted from the ''poor'' relationships between the radiation oncologists and the medical oncologists practicing at the hospital.130 accordingly, the hospital transferred its oncology program to an office-based practice group owned by the hospital's non-profit parent institution. the radiation oncology group that had practiced at the hospital contested the transfer, as they would no longer see radiation oncology patients at the hospital. the radiation oncology group claimed that the transfer ''was unrelated to quality-of-care concerns" and there­ fore impermissible.131 in rejecting this position, the alabama supreme court held that the hospital's decision to transfer oncology services "did not violate the medical-staff bylaws" because the transfer decision was a "business deci­ siono" that the hospital was permitted to make under its corporate bylaws inde­ pendent of the medical staffbylaws.132 these four recent cases suggest that courts are increasingly sympathetic to hospitals' assertion of their own independent institutional interests and that as a result credentialing on grounds other than medical competence is gaining judi­ cial assent this is an especially important and positive development in cir­ cumstances in which hospitals are seeking and exercising authority to better achieve institutional objectives such as quality assurance, accountability, and cost containment these recent cases also are suggestive of a broader set oflegal and regula­ tory objectives. first, the legal and regulatory environment should not have a large impact on how physician-hospital relationships should be mediated. the lack of a ri­ gid regulatory structure for idns should be retained; the existing regulatory approach for hospital governance should not be transferred to the idn setting. second, regulatory flexibility and regulatory neutrality should be the guid­ ing objectives of public policy in this arena. third, the gainsharing demonstration should provide an occasion and a vehicle for initiating a comprehensive review of existing doctrines (e.g., anti­ kickback and anti-self-referral laws) so that the focus of regulation is on inap­ propriate outcomes (such as anti-competitive conditions or poor quality results) but is crafted to permit innovative structures.133 127 /d at 159. 128 radiation therapy oncology, p .c. v. providence hosp., 906 so.2d 904 (ala. 2005). 129 /d. 130 id at 908. 131 id at 909. 132 /d at910-ll. 133 the enactment of the financial at-risk safe harbor under the anti-kickback law and the 2007] of doctors and hospitals: setting the analytical framework 237 finally, constraining the rate of growth of costs is now more than ever a quality-of-care issue134 and an access-to-care issue. broader and more afford­ able coverage for medical care is directly linked to the cost of care.135 the need to deal with cost-of-care issues suggests rethinking the regulatory structure of hospitals, allowing a more direct mechanism for incorporating cost factors into medical care decision making, 136 while at the same time maintaining regulatory flexibility for non-hospital organizational forms of physician-hospital relation­ ships. in sum, incorporating economic considerations into medical care decision making is a critical policy objective. physician-hospital arrangements outside the traditional hospital governance structure still can act as important tools for achieving this alignment of interests, and as a result, encourage physicians to take costs into account in their decision making process. their form and struc­ ture should not be locked into a one-size-fits-all framework, and they should not receive carte blanche when concerns about quality or competition exist. because they remain relatively free ofbuilt-in regulatory obstacles to an appro­ priate structure, the varied organizational forms should remain available as new ways to create appropriate incentives for cost containment and quality assur­ ance. as robinson argued ten years ago, the appropriate organizational form should be seen as the "outcome of a competitive process in which particular forms survive., where they best perform the functions that need to be per­ formed.137 and, in a regulatory-neutral environment, public policy attention should tum to creating a system of competition that incentivizes the provision of good quality care and appropriately incorporates economic considerations binding advisory opinion process under the anti-kickback and anti-self-referral laws are exam­ ples of this type of approach. see havighurst et al., supra note 42, at 462-63, 495-96. in arrangements in which providers are financially at risk. for example, when managed care organi­ zations receive capitated payments from medicare, there is not a substantial risk of excess utili­ zation, unlike the situation in which providers are paid on a fee-for-service basis. if there is a concern, it is with quality assurance not overutilization. see timothy stoltzfuss jost & sharon l. davies, the empire strikes back: a critique of the backlash against fraud and abuse en­ forcement, 51 ala. l. rev. 239 (1999) (raising concern about quality-of-care considerations in capitated settings). use of financial inducements should be less subject to scrutiny on cost con­ tainment grounds in capitated situations. see blumstein, speakeasy, supra note 11. see also blumstein & sloan, supra note 9, at 78-82 (developing antitrust approach for specific contexts of antitrust risk). 134 see, e.g., radiation therapy oncology, p.c. v. providence hosp., 906 so.2d 904, 915-16 (ala. 2005) (harwood, j., concurring) (noting that a qnality of care concept is "broad enough" to encompass cost containment considerations). 135 the state of tennessee has recognized this in its reform oftenncare, the state's me­ dicaid demonstration. see supra note 24 (outlining the tenncare definition of medical neces­ sity that expressly incorporates cost considerations into the determination of medical necessity, which defines the scope of a public tenncare beneficiary's entitlement to medical care ser­ vices). 136 see blum, supra note 12; hall, institutional control of physician behavior, supra note22. 137 robinson, supra note 35 and accompanying text. 238 indiana health law review [vol. 4:209 into the medical decision making process, while also providing appropriate dis­ closures to patients and involving patients in shared decision making. transcript of the 2008 live symposium panel discussion* editor's note the following is a transcript of the live panel discussion presented on march 19, 2008, in the wynn courtroom ofthe indiana university school of lawindianapolis, following the 2008 mcdonald-merrill-ketcham memorial lecture and symposium. the mcdonald-merrill-ketcham memorial lecture and live panel discussion are presented annually by the indiana health law * the indiana health law review and the william s. and christine s. hall center for law and health at the indiana university school of law ~ indianapolis thank the following speakers for participating in the symposium and providing their unique and informative perspec­ tives on health care reform in america, as well as for reviewing and allowing the indiana health law review to publish this transcript. james buechler, md. director emeritus, richard g. lugar center for rural health aaron carroll, md. assistant professor of pediatrics in the children's health service research program, at the indiana university school of medicine, and an affiliated scientist at the regenstrief institute for health care matthew r. gutwein president and ceo, health and hospital corporation david orentlicher, md. samuel r. rosen professor of law, co-director of the williams. and christine s. hall center for law and health eric schmitz regional vice president, network development anthem blue cross and blue shield kevin speer chief strategy officer, saint vincent health the indiana health law review would also like to give special thanks to its executive business editor, mr. jacob v. bradley, its executive managing editor, mr. mark e. douglas, and ms. margie a. welsh, coordinator for the williams. and christine s. hall center for law and health, who worked tirelessly to make the 2008 symposium a truly memorable event. 464 indiana health law review [vol. 5:463 review and the william s. and christine s. hall center for law and health. the live panel discussion is, by tradition and design, a moderated and un­ scripted exchange of arguments and counter arguments generated by the dy­ namic tension existing in current issues pertinent to practitioners in the fields of both law and healthcare. to preserve the dialectic flavor of the 2008live panel discussion, the portion of the transcript presented here has been edited in form but not in content. during the editing process, a distinct effort was made to retain both the original tone of the panelists' remarks and the verbal manner­ isms of the individual panelists. health reform in america: getting beyond ideology to true reform march 19, 2008 dr. orentlicher: thank you. it's good to be here, good to see such a nice turnout, and we've got a great panel. it seems to me that today there ex­ ists an opportunity, a window, to bring about true reform of america's health­ care system. we all remember 1994 when it seemed like we were actually going to get healthcare reform and universal access. a lot of time and effort was dedicated to developing possible solutions. indeed, the clinton admini­ stration alone employed the services of 400 experts. however, in spite of all the effort, that window closed without getting true reform. but it looks like we've got another one of those windows of opportunity. the leading presiden­ tial candidates are all talking about it; and it's a major part of their platforms. so that's the question. will it happen? what are the prospects? whether we have barack obama, hillary clinton, or john mccainand it seems like we're going to have one of those administrations are we, as a nation, going to achieve true healthcare reform? and if we do, what is it likely to look like? what should it look like? those are the questions with which i would like to begin our discussion. dr. buechler, would you please start us off? what are the prospects, do you think, and will we get to the right place this time? dr. buechler: well, it is interesting. when president bill clinton took office, there was a great hope that we would have healthcare reform, some­ thing i was quite interested in at the time. so i wrote hillary clinton a letter in the interim before president clinton took office. i said, "i don't know what your role is going to be in this new administration, but we really desperately need some changes in our healthcare delivery system." and she wrote back to 2008] getting beyond ideology to true reform 465 me, actually. i've still got it. it's a little postcard. she said, and i'm paraphras­ ing here, "i don't know what my role is going to be either, but i'd agree that we need some changes in our healthcare delivery system." in retrospect, we should have known that the clinton plan was going to fail. in part because it happened at the beginning of an administration that was not prepared to make the really hard decisions that you have to make about healthcare reform. the special interests ruined that opportunity, in my estima­ tion, plus the plan wasn't a very good one. but now we have another window of opportunity, and things have gotten a lot worse in that time. the access to care in our country is appalling especially in rural and inner­ city areas, areas where i've worked really hard to develop assistance projects and provide care. it is appalling. the world health organization even says that some parts of the united states are like a third-world country. so despite spending over $7000 per person in the united states per year on healthcare, by far the highest expenditure, we rank the lowest among first-world countries. one good statistic that i like to use to help people understand how significant the problem really is, is the measure of healthy years lived. that's what we want. we want to be healthy for as long as we can be. we rank twenty-eighth there, between portugal and slovenia. that's our healthcare delivery system. so there is a great opportunity, i think, for healthcare reform now. what should it look like? i'm going to give my opinion, and then i'd like to hear what others think. i think it should look like this (indicating a medicare card). my medicare card my public part of the partnership, my medicare supplement card issued by an insurance companyit's plan f. i am sure that you are all aware that there are plans for medicare supplements. they're all the same. every plan f is exactly the same. you can choose your plan, and you know that you are going to get exactly the same plan. and here is my part d card (indicating a medicare card)this is my prescription card. now, there are some problems with this system, but they'll get resolved eventually. in any case, when i go to the doctor i hand this card to the front office. when i do, they know exactly what my medicare coverage is, they know exactly what plan f coverage is, and ifl need a prescription i know i've got my part d coverage. they know what that is too. so there is no question about what my coverage is. medicare takes care of the oldest, sickest, and disabled portions of the population in the united states of america. administrative coststhat means dollars that do not go towards healthcare in any way, shape, or form for healthcare spending in the u.s. is about thirty-two percent as compared to six­ teen percent in canada. and does anybody want to guess what our inefficient public system administrative expense is? does anybody know? there are probably some people here that know. response: about three percent? dr. buechler: yes, about 3 percent. that's what it costs medicare to deliver medicare dollars. it's actually a pretty efficient system to administrate. 466 indiana health law review [vol. 5:463 so moving down the medicare age and making it mandatory for all would be one easy solution to the healthcare crisis. we heard in an earlier presentation that people don't want, mandatory programs, but you have to have both the healthy people and the unhealthy people in a system. you cannot cherry-pick benefit recipients. we see this a lot in medicine today, insurance companies do it and specialty hospitals do it. there are all kinds of horrible approaches to medical care that rely on it, and i hope that we can talk about the problems as­ sociated with these approaches today. but i do think, and this is my personal feeling after thirty-eight years of seeing patients and seeing what they go through, that if i have a medicare patient walk in the office and hand me this (indicating a medicare card), they're going to be satisfied. so that's my as­ sessment of healthcare reform. dr. orentlicher: dr. carroll? dr. carroll: let me be very clear upfront. i'm a health services re­ searcher, so i always come down on the side of science and empirical research. i ask, "what does the evidence and research show us?" and when i talk about healthcare reform, i talk about health insurance. the slates are always full of new facts and figures that can help us learn about both our own healthcare sys­ tem and the healthcare systems of other countries. and because such informa­ tion is readily available, my views on the subject of "change" have changed over the course of my lifetime. when i began researching these issues, i ap­ proached healthcare research from an ideological or rhetorical standpoint, but over time the evidence really has, to some extent, pointed in another direction. it's very hard to argue from any point of evidence that the united states' healthcare system is a good one. it does not matter what metric you pick for judging the quality of our healthcare system be it infant mortality, be it ma­ ternal mortality, be it the percentage of people we immunize correctly, be it how many people are happy with the healthcare system, be it the number of preventable life years lost. it does not matter what metric you pick. we're pretty much at the bottom of the industrialized nations, which is frightening, considering that we spend two to three times more per person than any other healthcare system in the world. indeed, at this point we are paying over two trillion dollars a year. and if you believe in the free market and you believe the rhetoric of what we've all been told, then by spending that much money we should be seeing dramatic results and significant returns. we don't. we have, based on any metric of quality, one of the worst healthcare systems in the world, and perhaps the worst healthcare system of all of the industrialized na­ tions. so you would hope we'd have phenomenal healthcare access. after all, if we're not getting quality, then at the very least everybody should be able to get access to the basic benefits of the system. but as we all know, forty-seven mil­ lion americans have no health care insurance. that's forty-seven million amer­ icans, remember, out of the total population who are not over the age of sixty2008] getting beyond ideology to true reform 467 five, because everybody over the age of sixty-five has medicare. that's forty­ seven million americans, who are not extremely poor, because all of them have medicaid. that's forty-seven million americans who are not in the military, because military personnel have va insurance. that's forty-seven million peo­ ple out of the rest of us. it's a huge population. that's also forty-seven million people who lack health insurance for the entire year, not that portion of the population who lack health insurance for six or nine months. if you extend the accounting to that last group, the number of uninsured americans likely jumps to over eighty million uninsured a year. that's a huge number of people with­ out healthcare. if you've heard the arguments against moving towards a national health­ care system or medicare for all, then you know that as soon as we start talking about a nationalized system, everybody throws out concerns about rationing and waiting lines and things like that. however, if you don't think we're rationing healthcare in this country already, you're really putting the blinders on. we ration by whether or not you have insurance. forty-seven million americans have no access to the system. that's rationing. also, these days if you're from the medical environment and you try to lock in a time to conduct a cat scan or an mri, or you try to get an appointment as a patient, there's always a waiting list all the time. the idea that somehow there's not wait times for things al­ ready in this country is to some extent ignoring the real picture it's just how we choose to ration. should we ration based on good evidence about whether to cover the things that are most cost effective in our society? should we ration by which drugs work the best and provide the most value? should we ration by which procedures we know have the best outcomes? or should we just ration on money? so given that we ration healthcare already, it's clear that we're also doing poorly with regard to access. so then, if we're not getting good quality, our costs are through the roof, and our access is terrible, we have to ask if we have the will to change the sys­ tem. and this is where you get the common argument about how the united states will never accept any sort of major reform, and it's a very powerful ar­ gument. people in this country are scared very easily. however, the arguments made today against healthcare reform are virtually the exact same arguments that were made years ago when people opposed the passage of medicare. "it'll be the death of the system." "it'll be socialized medicine." "it'll be the worst thing that'll ever happen." "there'll be rationing." "there'll be less quality." "it'll cost us everything in the world." "it'll be incredibly inefficient." all these statements were made about medicare, and today you hear them in dis­ cussions about national health insurance. now, medicare was very difficult to pass, but they got the political world together and they did it. and there's not a politician alive today that's going to run on a platform for repealing medicare. nobody thinks medicare's a bad idea. oh, it's underfunded, and it could work better in many different ways, but a lot of its problems are narrowly related to money. and how do you fix the problems? how do you eliminate waiting lines and rationing? simple, you just 468 indiana health law review (vol. 5:463 to throw more money at the problem. the reason that a lot of other countries have rationing and have difficulties with lines is because they underfund their systems. we're already used to paying two to three times as much as every­ body else. a very well-run national health insurance system in this country, with the kind of money that we'rewilling to throw behind it, would very likely be the best in the world. as dr. buechler here said, medicare is the most efficiently run approach to healthcare in this country. it's the most efficient form of health insurance, and it lacks the red tape that you normally see. usually when i talk about this issue i look at and discuss the empirical evidence. according to current evi­ dence we have terrible quality, unbelievable costs, and terrible access. we're failing in every realm. moreover, the evidence shows us clearly that every oth­ er industrialized nation that has approached the healthcare problem differently has better quality and better access for lower costs. this suggests to me that what's really necessary to change the health care system in america, is a change in political will. so the question we began with was, "is there an opportunity here?'' ab­ solutely, more and more people every day are fed up with the system. at this point, depending upon which survey you believe, somewhere between two­ thirds and three-quarters of americans favor health insurance reform even if it means higher taxes. people don't favor the war if it means higher taxes. i mean, we're not willing to pay higher taxes for anything, but people are actu­ ally willing to say they'd pay higher taxes for health insurance. a significant majority of doctors are in favor of national health insurance. really, the only groups that don't appear interested in national health insurance are special in­ terest groups. therefore, we have to just decide is this a time for change? it's a matter of political will. and hopefully, there'll be leaders. i don't care from which side of the aisle, because i'm not ideologically involved in this. we have to have leaders who are actually willing to exert the political will to make some significant changes happen. dr. orentlicher: mr. gutwein? mr. gutwein: thank you. well, i'm shocked by the communist so­ cialist rhetoric i just heard from this side of the table. dr. carroll: there you go. mr. gutwein: what i believe dr. buechler and dr. carroll were de­ scribing is the desirability ofi think what's called in the industry, a single­ payor system which is what we have with the medicare system and which is what most other countries have as well. it might be best described as the social­ ist communist system. but it is the system that every major industrialized na­ tion in the world has except for one, and that's us. and as has already been described, we are the system that has the highest cost, the lowest quality, the 2008] getting beyond ideology to true reform 469 least access, unconscionable racial health disparities, and incredible bureauc­ racy. so why don't we have the single-payor system? getting back to dr. orentlicher's questions though, "are we going to have health reform, and what would it look like?" i suppose it depends on how you define reform because there is, i think, a lot of reform going on right now. the system is very dynamic. it's changing all over the country. here in indi­ ana i think some very positive reform measures were recently proposed by governor daniels and passed by last year's general assembly that expanded access to healthcare to a number of populations that otherwise would not be eligible for medicaid and could not afford private insurance. that opened up slots (access to medical care) to about 125,000 previously uninsured hoosiers, and i certainly would call that reform. there are lots of other reforms going on around the country too, in massachusetts, california, florida, and arkansas. i think there's a lot of reformative activity going on around this. the question, i think, is are we going to get to the point that the two doc­ tors proposed, which is the same point that every other major industrialized country has gotten to except for ours. there is no serious proposal on the table right now that actually suggests that we ought to have a single-payor system. senator mccain is not proposing a single-payor system, senator clinton is not proposing a single-payor system, and senator obama is not proposing a single­ payor system. they're all proposing a sort ofhigh route to what we have now; an expansion of the role of the federal government in subsidizing care com­ bined with private healthcare insurance to augment that approach. is that a place where we ought to be? doctors carroll and buechler have already stated that that's where we ought to land. and i'll confess my sins. i think that ultimately our country will get to a single-payor system, but the change will be incremental. i don't think we're going to get there with a single proposal by the next administration, whichever administration that is, and all of a sudden adopt a single-payor system. i think the kind of approach that's being taken right now, which is small steps toward expanded public funding of healthcare with an expanded risk pool that is less expensive to administer and less expensive to fund, is one way to get there. so why do we resist that in this country? i've sort ofbeen making fun by referring to the socialist communist system. why are we so adverse to a single­ payor system? i think it is a curiosity. i think that there actually are very basic, fundamental and economically sound reasons why the single-payor system is the most economically prudent system to fund healthcare. in other words, it is consistent with economics. it's not anti-economic. and the reasons are very simple. insurance is a risk pool. i want to make it clear that i am not in any way anti-private insurance. in fact, r m certainly not anti-anthem. i think an­ them!wellpoint is a terrific company that operates with incredible efficiency, an efficiency which benefits all anthem policyholders. and anthem, all insurance companies by and large, operate within the rules that they were given, but i think that certain elements of the rules constrain them. and that constraint is this: insurance is a risk pool, and larger risk pools are cheaper to operate than 470 indiana health law review [vol. 5:463 smaller risk pools. larger risk pools have lower administrative expenses and a greater ability to manage outliers within the risk pool. that's why the medicare system, which is the single largest risk pool we have in this country, has lower administrative costs than lots of very small insurance companies that have very small risk pools. it's just a pure matter of economics. if we can create larger risk pools in­ surers can reduce their costs. which is exactly why anthem's costs are so low: anthem's now the largest insurance company in america, and they are able to take advantage of their large risk pool. their strategy is exactly the right one. and so, if we can do that on a national basis, we will lower the administrative costs for everyone. in other words, the single payer system is highly consistent with economic principles. it doesn't represent an effort to get around the mar­ ket. with that i'll tum it over to the true risk pool expert. dr. orentlicher: okay. mr. schmitz? we do want you to have a job. mr. schmitz: do i think there's going to be some of the right reform? some of the concerns that i'm seeing are in the payment mechanisms that are out there right now, medicare and private health care insurance. right now in­ surers pay providers every time that there's a medical problem. we don't pay physicians and hospitals to keep you healthy. we pay physicians and hospitals when you're sick. so one of the things that we're hoping to do with some of the reimburse­ ment that we're looking atand one of the jewels, i think, oflndiana's pro­ grams has been the indiana health information exchange ("ihie") the ihie is building some information databases that can be shared among all payers medicare, medicaid, anthem, and the like so that we can actually start reim­ bursing physicians and hospitals based on their outcomes instead of just paying for every time you're sick. not that physicians or hospitals do a bad job, but they earn their income when you're sick. so if there's a way that we can keep the providers in business to keep you healthy, i think that could create a better outcome for all of us. it seems to me, that the current debate is focused on who should pay, and how many payers there should be. the current focus is not on the value equa­ tion of best quality for the lowest cost. and that's a problem, because low cost is necessary so that we, as an economy, can compete. indiana has some of the highest-cost healthcare that i deal with. wellpoint operates under the blue cross and blue shield license in fourteen different states. indiana pays some of the highest costs per member. so i'd like to throw this out in the debate on expanding access to care, and i think there was a good question here regarding access to care. specifically, "what does access to care truly mean?'' does it mean that every individual should have a health insurance card or has the right, if you will, for a third­ party-payor to pay for something? one of the things that i run into a lot with 2008] getting beyond ideology to true reform 471 providers is the question of what anthem pays compared to what medicare and medicaid pay. medicaid paysand mr. gutwein, you can correct me ifl'm wrong here pays less than twenty cents on the charged dollar. mr. gutwein: medicade pays twenty percent of costs. mr. schmitz: medicare, on the other hand, is paying about forty cents on the charged dollar. and other health insurers are paying sixty to seventy percent of the charged dollar. what i mean by the charged dollar is what the hospital charges, that's what is paid. so rather than talking about access to care generally, i should point out that we're already starting to see an access issue in indiana around primary-care, an access issue caused by the decrease in the number of physicians going into primary-care. and right now we have a sys­ tem in which private payers pay much more than what medicare and medicaid reimburses physicians and hospitals. as the single-payor system rolls out, see­ ing where our tax dollars are, i don't think that medicare -let's say medicare is the single-payor system that medicare's going to automatically increase the rates paid to providers to the level we, as private-payors, are now paying. i would assume that ifthere was a single-payor system, what commercial payers are paying now would be reduced, and providers would be getting paid what medicare is paying. that could be a problem, because salary rates for pcps are, i think, only a little over $125,000 now. if you're seeing family physicians not go into primary care because of the economics today, what's going to hap­ pen if we go to a single-payor system that actually reduces the salary even fur­ ther? dr. orentlicher: mr. speer? st. vincent hospital, whatdoyousee there? mr. speer: i would be remiss sitting in this law school ifl didn't say before i begin that, as the representative of a not-for-profit organization, noth­ ing i say should be considered an endorsement or commendation of any of the political parties or their agendas. these are simply my opinions or observa­ tions. you asked a couple questions. i think i jotted them down correctly. one was, "will we get to the right place." because we started with dr. buechler, perhaps we framed the "right place" as being a single-payor system. if that's the "right place," then my answer is that i think it's unlikely we'll get there. having spent a number of years lobbying for both the indiana state medical association and the hospital association, both here and in washington, d.c., i would suggest that government isn't going to change under any of the admini­ strations that we're looking at. the other part of the question was, "what would a changed system look like?" well, i think healthcare is already changing to accommodate what dr. buechler and dr. carroll are describing, 100% access at more efficient access 472 indiana health law review [vol. 5:463 points. from a savings in health perspective, our mission statement is that we have healthcare that works and that no one is left behind. we advocate for 100% access and i 00% coverage, but we deal in a world in which those aren't always possible. whereas we push and strive for those ends, we aren't there yet, but we are evolving. when i say"we," it's more than st. vincent. it's healthcare in indiana. if you look at our demographics and the patient base in our state, we've seen an increase in premiums. it's not a reflection on anthem, but the reality is that there has been an increase in premiums generally. we've seen the number of employees insured by their employer reduced. and we've seen an increasing number of people who have higher pay or higher deductible premium insurance plans. so if they are not using a health savings account, they may have the first $3000 or $4000 or $5000 coming out of pocket. those factors in and of them­ selves are forcing healthcare and the healthcare delivery system in indiana to change, and probably change ahead of whatever washington or the state of indiana would like to see done. because the healthcare providers are trying to adapt, trying to prepare for those things. i think a couple of things will change in the next four years, no matter who's elected president or what the make-up of congress is. i think we're go­ ing to see an increase in transparency. you're going to be able to, within the next four years if you can't already, go online and understand what the true cost of your care is going to be. if the first $3000 or $5000 is coming out of your pocket today, while two years ago your employer paid for it, now all of a sud­ den you care about the costs. so if you can go to minute clinic and get a diag­ nosis for your son's pink eye in five minutes and pay thirty-five dollarsit says on the sign on the wall that it's thirty-five dollars -rather than call your pedia­ trician and spend most of a day and a half trying to get your kid in for a check­ up, and then pay sixty-five to eighty dollars out-of-pocket, that's going to drive change. we're seeing both physicians and hospitals react to that changing real­ ity. the health care system is going to change and it is changing. if you ha­ ven't experienced it already, it's changing right now in the state, becoming friendlier to consumers. it has to, not only for those people who have the high­ er out-of-pocket deductibles, but also for those people who don't have insur­ ance at all. and i'll speak specifically about st. vincent. if you're poor and can't pay in the state of indiana and you come into a st. vincent facility, we're going to give you a card that looks just like the insurance card you get from anthem, and you can access our physician network, you can access our hospi­ tals with that card, and receive care in a dignified manner. today, you have to be consumer friendly to the poor. you have to be consumer friendly to those who are paying out-of-pocket. you have to be consumer friendly to the payers. indeed, the payers are increasingly more interested in quality, and less willing to pay for mistakes, or to overpay for access generally. healthcare is changing around us in response to that. governor daniels passed very good legislation two years ago requiring hospitals to report on nev2008] getting beyond ideology to true reform 473 er-events. that's drawing people's attention to it. you can go online and find out which hospitals have more never-events than others. patients care about that. so i would argue that whether or not one of the elected officials changes healthcare, i think healthcare is currently changing without their help and that it's changing around those issues. it's going to become more consumer friend­ ly, more transparent, and you're going to understand what you're buying and what you're paying for. the ihie is a great example. the evolution of that type of program for the providers in indiana and nationwide would be the key to changing how healthcare is delivered. if those things happen in the next four years, i think we're going to see significant change in our healthcare delivery system. but will we become a single-payor country in the next four years? i don't believe so. dr. orentlicher: none of the leading presidential candidates have come even close to advocating that. obama's hope is that by making it more affordable, people will voluntarily take up insurance, clearly less than a man­ date. you're talking about the move toward patient empowerment achieved by telling patients what procedures and services are going to cost. recently, we've heard a lot about patient responsibility in terms of costs, and we've heard even more about patient responsibility in terms of smoking and other risks for healthcare. i think that there are two ways to look at this. one approach is to view these changes as good, shared responsibility. although as professor an­ nas said, what does it mean to say shared? either you're responsible or you're not. the thrust behind shared responsibility though, is that patients all make some individual contribution, a contribution that is individual in the sense that if we just stopped smoking, exercised, and ate better we would solve all the problems facing healthcare. if we all knew what we were paying for, we'd be more responsible. we wouldn't run to the doctor every time we saw a lipitor commercial and ask for a new prescription. as calabresi and bobbitt would say in tragic choices, this is a way to hide the fact that we are rationing care and not giving everybody the care they need. so instead of taking the responsi­ bility ourselves and saying up-front that we're not going to give some people care while at the same time giving other people care, we are trying to put the blame on the patient in kind of unfair way. are we suggesting that the patient really has more responsibility than they deserve? is this a way for society to avoid its obligation to make sure that people have the care they need? what about this move toward patient responsibility? mr. speer: well, i don't think that it's an attempt to shift blame onto the patient. indiana is one of the heaviest states. we're one of the states with the highest incident of smokers. we're arguably the least healthy state as are­ sult of those statistics. all you have to do is talk to dr. buechler about the pa­ tients he sees. i'm not going to speak for you, doctor (carroll). dr. buechler has been managing obese individuals, smokers, and diabetics. that can be a 474 indiana health law review [vol. 5:463 difficult task, depending on the individual's mindset regarding their disease and their desire to improve their health. there have been a number of initiatives by employers in central indiana to incentivize individuals to lead a healthier lifestyle. these initiatives include, providing healthier food in cafeterias, and reducing the portion of the out of pocket insurance premium paid by employees if they engage in certain healthy lifestyles. i don't necessarily think or haven't noticed any great change in peo­ ple's behaviors as a result of these initiatives. but trying to incentivize people to do those things, and trying to educate them about the harm those things cause is justified. even if such incentives don't help the incentivized person, maybe they help their child or their child's child. i think we have to talk about it. we have to be aware of it. we try very hard as a healthcare system, and we have seventeen hospitals in a forty-five county service area. one of the things we're very proactive about is smoking cessation and we try the best we can to carry that message throughout our service area. we've had marginal success, i think, at st. vin­ cent in getting people to stop smoking. so i don't think it's an attempt to shift blame or shift the cost. but, to give you one person's opinion, i think that if we can encourage people to be healthier, we ought to do it. mr. schmitz: i would have to agree with mr. speer's comment that we have very little evidence to support any assertion that there's been a lot of change out there. with the increase in deductibles, however, employers do have the potential of reducing their costs. but, i think what employers would do and you see this with many employers that have profit-sharing plans, the purpose of which is to actually get the employee invested in the performance of their organization is impose a higher deductible on health plans. so in a sense, the cart truly is a little bit in front of the horse on this one. anthem has a comparison tool that is available to all of our insured clients today. let me give you a brief overview ofthe tool. it lists thirty-nine different procedures. right now if a member or any patient goes to wishard or st. vin­ cent they really don't know how much it's going to cost. providers are not in­ tentionally vague with regard to cost. it's just the historical nature of our system. first you receive the services, and later, when you get the bills, you see the cost associated with each line-item. if you think about a bill for a car, the bill would list the cost of the tires, the shocks, and so on. the big difference is that the costs associated with cars are very transparent and easy to compare. but, when a consumer like me tries to determine the cost of having his or her gallbladder removed at st. vincent, as compared to the cost at wishard or at one of the surgery centers, there is no easy way of comparing the costs. so we built this tool to aid in the comparison. tools like this are needed if employers are going to get their employees to act as consumers in the healthcare system. if folks like anthem or the service providers don't have these tools available to inform patients about cost, the patient will really never know what to do. they'll keep going to the same place. so we need more robust tools that actu2008] getting beyond ideology to true reform 475 ally show quality outcomes and overall costs. that would allow us to clarify the overall value proposition. such tools are and would be very useful, but i don't think that the transparency they provide can cause a true shift in overall patient responsibility. mr. gutwein: our lifestyles that we lead. i'm hoping the doctors over there can explain to me why the french can smoke, drink burgundy every night, eat foie gras, never run, and still stay skinny. it's wrong, and we need to figure out why. healthcare reform is multifaceted, and i'm an enormous believer that we ought to do everything we can to reform our lifestyles. we shouldn't smoke. we shouldn't drink wine every nightevery other night maybebut not every night. we shouldn't be eating mcdonald's hamburgers three times a day. we ought to stress those good behaviors because they are critically important. i also am a believer in economic incentives for people to alter their conduct. i do believe that economic incentives work. in fact, i see dr. virginia cain, the director of the marion county health department, has joined us to­ daynice to see you, dr. cain. we use economic incentives all the time in programs that dr. cain and i are working on at health and hospital. for ex­ ample, at-risk pregnant mothers who are at risk of having low birth weight ba­ bies, we provide those women economic incentives to go and get their well­ baby care visits, to take their vitamins, and to do all those very important things. when they do, they get little coupons, and they can take those coupons and get car seats. we actually partnered with st. vincent in one of our clinics on this thing. and it turns out that those economic incentives work and that the young mothers to whom we can offer a car seat or a free crib or baby clothes come in and actually get their visits. as a result, they have full-term babies and fewer premature deaths. so incentives work and i think we ought to use them all over the healthcare system. having said that, i am highly dubious that what i think is called con­ sumer-driven healthcare can offer the kind of huge gains or the radical reforms that will bring down healthcare costs to the levels that exist in other countries. in other words, that consumer-driven healthcare can save us seventy-five per­ cent of our total health care costs, which is how much more we spend than the canadians. the canadians spend only about twenty-five percent of what we spend on healthcare. the french spend about fifty percent. in other words, there are not fifty percent gains to be had in consumer-driven healthcare, and here's the reason why: it' becauseand these are basic economic reasonsit turns out that economic incentives only work for items that have what econo­ mists would call an elastic demand. in other words, where the price actually can affect conduct incentives are effective. however, really expensive health­ care procedures are inelastic. in other words, we do not shop for price when we need something that is really expensive in healthcare. i'm an enormous believer in the market. when you need a pair of blue jeans, the market is perfect at saying, "if you want to go down to goodwill, you 476 indiana health law review [vol. 5:463 can spend fifty cents for a pair of blue jeans. if you go to old navy you'll pay ten dollars. if you go to levi's, you'll pay thirty dollars. or, you can even find a place to pay $200 for blue jeans if you want." in the market, you have those choices. but when you have a heart attack and you need a heart catheterization immediately, you do not want your doctor to come to you and say, "would you like a goodwill heart cath? it's one dollar. slightly used, but it's pretty good. or, you could go with the old navy heart cath. the kids love it. it's a great bargain for people on a budget. or you might choose the basic levi heart cath, its price and quality is sort of in the middle. we could even give you the dolce & gabbana heart cath." that's just not the way you buy healthcare when it's really expensive. what economists would say is that healthcare is completely inelastic. what you want is the doctor that can fix you perfectly and immediately, irre­ spective of the cost. that's what we expect of our healthcare system. mr. schmitz is exactly right. different systems do have different costs. that's the case. but, what we expect of our system is that every doctor that touches us will provide the highest quality care available while performing to nationally accepted standards. that's what we want to pay for. or, what we want some­ one else to pay for. we don't want an albanian medical student who's never done a procedure before working on us. we want a real doctor. that principle, that major health care costs are inelastic, is a fundamental aspect of our system, and that's why there are important but limited gains to be had from incentive or consumer-driven healthcare. there's one other basic economic principle that's at work here too. that is, healthcare has what economists call economic externalities. in other words, the purchaser of a healthcare service does not bear the full economic cost of his or her decision. to expand upon an example given by dr. annas earlier, if a person lands at the indianapolis airport today and is a carrier of sars, we could treat that sars patient perfectly with $500 of antibiotics. so we could grab her and say, "you've got sars." and we could pay her $500 so that she can seek treatment. but, she might say, "i'm feeling pretty good today. there­ fore, i'm going to take that $500 and i'm going to buy food for my children, pay the rent for our apartment, and put the deposit down for school books so that my kids can get an education." that's how she might choose to use that $500. if those are the choices she makes, and for her they make economic sense, then for her those decisions are the correct economic decisions. but, if she then gives sars to her children, who go to school and give sars to eve­ rybody else, suddenly we have a multimillion dollar epidemic, simply because she did not bear the full economic cost of the decision she made about health­ care. that is a principle that plays out every day in healthcare, and that's why an ordinary free-market healthcare system will not inevitably lead to the most rational and cost-effective result. economic externalities are powerful in healthcare. so you can't expect ordinary free-market principles to have the same influence upon healthcare choices as they would upon a person seeking to purchase a pair of blue jeans, which have no economic externalities. 2008] getting beyond ideology to true reform 477 dr. carroll: there are two main questions here which i really want to address. the first question is about "us." it's very tempting to want to be­ lieve that there's something special about americans and our lifestylessmok­ ing, drinking, whatever that drives up healthcare costs. the problem is that it's just not true. our smoking rates are the lowest of the top ten industrialized nations, and our drinking rates are pretty much the lowest as well. it's just not true that these behaviors are driving up our healthcare costs. there are some very obvious differences though. one is the way that we administer healthcare and health insurance across the united states. obesity, sure, we could all be thinner and we could all eat better, and obesity is a prob­ lem in this country. but, in the scheme of things, obesity is a relatively recent issue, and our healthcare problems have been going on for a long, long time. the other difference is related to the idea of consumer-directed healthcare, and that one's complicated. again, it's very easy to want to believe what i call, "the moral hazard," because it makes a lot of intuitive sense. the moral hazard is the idea that if we all had some skin in the game, we'd care more. in other words if i knew that my health care costs were coming out of my pocket, as op­ posed to someone else's pocket, i would be more careful with how i spend my healthcare dollar. there are a number of problems with this argument, this "moral hazard," the frrst being that somehow we don't all have skin in the game already. the idea that the taxes we're paying to medicare, the taxes we're pay­ ing to medicaid, and the amount of money that each of us individually pays for health insurance somehow doesn't count and that we, therefore, feel the need to spend willy-nilly. the second problem is the idea that somehow healthcare is like any other product in this country. that if it was free, everybody would want it. i doubt that if colonoscopies were free many people in this room would start buying them by the dozen, or would say i need some extra chemo treatments this year, or maybe an open-heart surgery because now it's free. most people don't want to get healthcare. it's not as if all of a sudden when it became free everybody would just immediately want more. would some? sure. people are always going to abuse the system. but the idea that giving consumer-driven healthcare to consumers is somehow going to control its costs has two real strikes against it, and if there are any take-home messages that i hope you get from what i'm saying i think they would be these. the first is that this topic has already been studied. there was a study done by the ram corporation a number of years ago. it's really the only major randomized controlled trial of consumer-driven healthcare that i am personally aware of. the study found that when people who weren't used to controlling their healthcare dollar gained access to consumer-directed healthcare; they ac­ tually did spend less on unnecessary health care. it worked. the problem is that they also spent significantly less on necessary healthcare. apparently, the aver­ age person can't tell what's necessary and what's unnecessary when it comes to healthcare. what they do is try to save money. this savings is not directed to 478 indiana health law review [vol. 5:463 some medical good. they just try to save money overall, which really doesn't work in the long run when healthcare related issues are involved. the secondand this is probably the most important pointis that about eighty-five percent ofhealthcare costs in this country are spent by about twenty percent of the total population. let me say that again. about twenty percent of people in this country are responsible for about eighty-five percent of our na­ tion's two trillion dollars in annual health care costs. the chronically ill, people with care givers, people in icus, they account for the vast majority of our healthcare costs. none of that can be affected by an msa (medical savings account) program. after all, the expensive twenty percent blow through their deductible in the first few weeks of the year. what msas do is they allow peo­ ple at the other end of the spectrum not to spend money. the top twenty or thirty percent of healthy people in this country spend nothing on healthcare each year anyway. so yes, they'll get all their money back, but we need that money to make the system work. insurance works by taking money from healthy people and using it to take care of the sick. your car, when you have a crash, gets fixed by the money from people who did not crash their car that year. when your house burns down, the money to build it again comes from the people whose houses did not burn down. that's insurance. insurance has to take money from the people who don't get sick and give it to the people who do. and if we return all the money to the people at the top end, the twenty, thirty, and forty percent of peo­ ple that have no healthcare costs, nothing will change at the other end of the spectrum with the eighty-five percent of costs from the most costly twenty per­ cent of the population. we wouldn't really achieve any significant drops in cost, and the system would likely fall apart. the eighty-five percent or more of costs at one end of the spectrum are to some extent inelastic. we cannot make chronically-ill people use less health­ care. unless we make a major change in our approach to dealing with end-of­ life care generally, we won't be able to reduce costs by returning a few thou­ sand dollars to consumers. so while these ideas rhetorically make a lot of sense, when you look at the economic realities involved and the true hard-core facts, they really can't be expected to make much of a difference in the long­ run. dr. buechler: that was brilliant. and it's interesting, i've never met dr. carroll beforethe young physician and the old physicianwe agree completely. and the thing about it is that most physicians who are in the trenches doing primary-care and taking care of underserved populations will agree completely with what he has said. and i hope with what i'm going to say right now. to begin, i want to ask a question. and i would like a show of hands, if you are comfortable doing so. how many people here don't have health insur­ ance? one, and there might be another person or two who's also in a time of transition. most of the forty-seven million people who do not have health in2008] getting beyond ideology to true reform 479 surance are the working poor. sometimes the wealthy are affected too, the up­ per fifty to sixty percent, but not very often. there are a couple reasons for that. first of all, i would venture to say every person in this room has an iq above the national average of 101 or 102, whatever it is. now, half the people in the country have iqs below that. and if you don't think intelligence has something to do with healthcare and making decisions about whether you're insured or uninsured then you are out of touch, and you need to spend some time taking care of some of this state's underserved population. tell me, is that something you deserve, to have your iq higher? did you do something worthwhile in your life to make your iq higher than the average? no. you may have grown up in a good environment, may have had some good parents, may have had a pretty good education, but inherently your ability to learn, transmit knowledge, and understand is a gift from our creator. be grate­ ful for it. what does that mean to me when it comes to healthcare? those of us who have been given much have to respond to those who have gotten less. it is easy to talk about taking responsibility for healthcare. but let me tell you, i've taken care of the underserved for thirty-some years. many of them struggle every day, and they can't even take the responsibility to find and keep a job or get and keep their car running. when you work with the underserved, you go into houses that have no reading materiali hope you've heard of a program called reach out to read, where we're trying to affect thatwhere kids are brought up with not a single thing to read in a house, and you ask them to take responsibility for their own healthcare or manage their healthcare dollar. you quickly realize that such an assumption of responsibility is just impossible for them. now, what does work? primary-care works. and not just primary-care the way we have traditionally known it, but a new type of primary-care. it's one that you see in community health centers, fqhcs (federally qualified health care centers), and rural health clinics. it's a kind ofprimary-care that we've tried to pioneer in some rural areas oflndiana: multidisciplinary health­ care. multidisciplinary healthcare is delivered to a population on a primary­ care basis with the help of physicians, mid-level providers such as physician's assistants, nurse practitioners, social workers, and mental health specialists. it's a team of people providing healthcare to the underserved population. what does that mean? it's a truism that a physician cannot be all things to all people cannot happen. it will wear you out. it will exhaust you. but if you have a team of people providing healthcare to a population, it works ex­ tremely well and is very efficient. so when members of the underserved por­ tion of the population have healthcare issues, and they have many, a multidisciplinary team is better able to respond than an individual primary-care specialist. the team serves as the primary-care provider and their costs are much lower in the long-run than those incurred by the individual pcp and a team of specialists. can i prove it? the only good proofthat i've seen is the study that was done by cms (centers for medicare and medicaid services). they did a study, i think it was, in iowa and they looked at populations ofmed480 indiana health law review [vol. 5:463 icare patients, and they found that if you take a population of i 0,000 medicare patients, and you add a specialist to the physician population in that group of i 0,000, any specialist, the cost for every medicare recipient in that group goes up about $700 a year. if you do the converse, take that same group ofmedicare patients, and add a primary-care provider, the costs to that group of i 0,000 medicare patients goes down by about $500 or $600 per person. we have not come to grips with the primary-care crisis in our country, and no healthcare reform is going to work none will workunless we deal with the primary-care crisis. in recent years, the numbers ofpcps have dropped by at least half. there are some good reasons for this, and some are actually being addressed by indiana university. it could be done better, but they're working at it. i don't know if dr. steve leapman's here, but he's the one, "shining knight," at iu. he's really working on changing who gets into medical school, because that's a big part of the problem. see, your kids, a lot of them, are likely going to want to go to medical school. how many of them are going to want to go to owen county, indiana, and practice primary-care? not very many i think. the other thing is this, if we're going to have healthcare reform, it's going to have to be reform from the grass roots up. it can't come from the people in washington. so it's going to take you people, a grass roots movement, to say, "we've got to change it." we've got to change it, and we have to do it in the best possible way. i'm sorry that i get a negative sense about healthcare reform from the insurance and hospital representatives on this panel. they make it sound as if we're going to end up with some disaster if what they're talking about happens. we need a unified, simple system. didn't dr. annas say that? and there is nothing simpler than this (indicating a medicare card), let me tell you, nothing simpler than this. dr. orentlicher: i have, i think, time for one more question before we turn to questions from the audience. i want to pick up on a couple points that have been made. that is, while we're waiting for overall national reform to change our system, other changes are being made, and there are some for better and for worse. it has been suggested that we need to place more empha­ sis on primary-care. so of the changes that the private sector can make or that government can pass short of an overhaul of the systembecause, after all, the government could pay for performancewhich of the options out there really are promising? if consumer choice, because of the problem with the chroni­ cally ill, has limited effectiveness, what really will work in terms of short-term, less than full reform, changes? dr. buechler: i'm not going to say where my politics are, but you might get a sense of them somewhere along the line. one thing that president bush did well was this: he said, at the beginning of his first term, that we were going to have a community health center in every poverty county in the united states. that bill was finally passed. he got that through just a couple years 2008] getting beyond ideology to true reform 481 ago. they provide access to care for people who have no access to care, and it's a good access to care. there aren't nearly enough of them. i don't know how many there are in indiana, but they provide great access to care, and open­ ing more of those clinics is something that could happen pretty quickly without a whole lot of federal money. dr. carroll: i want to just reject the question outright, but i will try to answer it. i think that we don't want to let the «good" become the enemy. there have been a lot of proposals in the last few years that certainly would do some good. s-chip (state children's health insurance program) for example, which unfortunately got vetoed some time ago, was a great idea. the s-chip program has covered significantly more children with healthcare. no matter how much you think that people should be responsible for their own health, it's very difficult to say that kids are responsible for their own problems. certainly, they didn't put themselves in the financial situation in which they find them­ selves. so covering all children, which seems politically reasonable, is some­ thing feasible that could probably occur. i want to reject the question outright, though, because i think that a comprehensive solution addressing all of the problems at the same time is necessary. i think what you're seeing in massachusetts, for instance, is what happens when you go piecemeal. the problem is, for example, that individual solutions to the rising cost of health insurance often seem to make sense at high levels of government. the problem is that health insurance is just too expensive. the average family plan for health insurance in this country costs about $12,000 a year. that's the average. not the high end, the average. tell me how a family who makes $40,000 a year with three kids after taxes is supposed to have an extra $12,000 laying around. subsidization works, but i don't care how much you subsidize, it won't solve all of the problems for a family in this situation. give them all their federal taxes back, 100% of them. what do you think they're paying, $3000? they still can't pay the $12,000 a year for a family pol­ icy. so you have to keep raising the level of subsidization. there's a lot ofpushback on subsidization efforts because it's intuitively difficult for people to grasp how a family making $75,000 a year can't afford health insurance. a lot of people just can't get their minds around that. it's just true. and so, while i think that there are some incremental reforms out there, i also think that they are all doomed to failure in the long-run. they're not going to contain costs. they're not going to take advantage of the large risk pools that insurers rely on. they're not going to necessarily cover everyone, even with chronic diseases. they're not going to always cover preexisting con­ ditions. they're very difficult to enforce. ultimately, they're very anti-public health. so again, i would not want to be the enemy ofthe "good." if you have the political will to pass legislation, i'm voting for it. i'm not getting in your way. but i think that if you truly want to talk about reform that's going to solve real problems, you have to think about medicare's history and you have to be will482 indiana health law review (vol. 5:463 ing to accept the fact that we had these problems before, and everybody made the exact same arguments. we still somehow got medicare passed. also, every other industrialized nation's dealt with this. i don't think they're necessarily that much smarter than we are, but they found solutions. and so, the arguments suggesting that we can't get this accomplished really don't stand up. mr. gutwein: i would propose a five dollar cigarette tax. that would be a short-term solution. i'm incredibly grateful to our general assembly for increasing the cigarette tax, and i would raise that tax through the roof. what's more i would do exactly what dr. buechler suggested and take money from that tax and invest it in primary-care, which is absolutely the biggest bang for the buck out there. that would have an immediate and profound impact on the state of our health nationally. mr. schmitz: there are a couple of things that i'd like to address. i think dr. buechler brought this up quite well the first is true support of pri­ mary-care. i think that support for primary-care is one of the ways that we can really help affect an overall change. i also think that what mr. gutwein brought up regarding the cigarette tax is a good idea. after all, a lot of that revenue went to fund healthy indiana. i also think that mr. gutwein mentioned earlier that indiana is at the forefront of some good healthcare reform, and of getting health care coverage out to individuals who don't have it right now. one of the components of that initiative was bringing skin in to the game. giving the pop­ ulation of individuals who has never had healthcare insurance skin in the game by providing them with a tool, like a msa i also think that one of the incre­ mental steps that we could take on the road to reform would be to increase transparency. we have a lot of great things in indiana and in the u.s. generally. but, the healthcare system is very complex. i've been in the game now for twenty years, and boy, i'm not ashamed to admit that i still get confused every day. it's a very complex system. i think that there is hope though, and that solutions are possible. one of the things that we looked at with wellpoint, and we have thirty-five million members, is the incremental value of apparently small sav­ ings. if for example, you're able to save a penny per month, if you will, on thir­ ty-five million members, that's a whole lot of money. if you think about the smart use of the healthcare system and what dr. carroll has brought up, you have to admit that you can't save a ton of money on those people who have chronic illnesses. there is some potential to save by getting those folks to the right care setting, but if you are able to save a penny here or a penny there, that can be used. it adds up, and it doesn't have to go into the healthcare system. if you look at some of the hospitals that we have in our comparison, which focuses on central indiana, we see extremes. the average price of a newborn delivery, the total priceincluding the physician and the delivery itselfruns about $7300 for per delivery. there are parts of our state right now where it costs over $13,000 for the same delivery. why does a delivery cost twice as 2008] getting beyond ideology to true reform 483 much an hour away from indianapolis as it does in indianapolis? that's just wrong. that's where increasing transparency by helping folks and their em­ ployers look at their healthcare dollars could be very beneficial. with transpar­ ency, local employers could work with hospital administrators and physicians to look at how healthcare dollars could be used more efficiently in their communi­ ties. not to beat up on the hospital or the physician. that's not what i'm after. i'm just suggesting that any viable solution must help us get our arms around the needs of the wider community. mr. gutwein mentioned the use of the in­ centives. are mothers not going in and getting their prenatal testing? is that an epidemic situation, if you will, in a given county? that could be what's driving the cost ofhealthcare, but until we get our arms completely around these ques­ tions and deliver full transparency, we're not going to know what the real cost drivers are. mr. speer: for those of you who aren't aware, a substantial part of the state of indiana is designated by the federal government as medically under­ served. marion county is a medically-underserved area. not at seventy-sixth and spring mill road, but at tenth and central. so the quickest and easiest win, in my opinion, and the win that can be done tomorrow is to increase incen­ tives for primary-care. we have a declining number of applications for students entering medical school. of the students who are entering, a declining number of those are pursuing or interested in a primary-care specialty. why? if you talk to those students when they're undergrads making the decision to go to medical school, once they're in medical school, once they're in a residency program, and once they're in practice for two to five years, or at any point in time, it's hard to find one that doesn't bring up the reimbursement and eco­ nomic issues of being a primary-care doctor. mr. schmitz pointed outand i think he's dead onthe average reim­ bursement for a family practice doctor in the state of indiana is around $125,000 a year. dr. buechler brought up the issue ofiq and the fact that the iqs of people in this room are above that ofthe average. the position of any individual entering medical school's iq, i would argue, is perhaps above most of those in this room. and they have choices as to what they can do or where they can go with their careers. there are exciting innovative opportunities out there which will reimburse them better than a pcps salary of $125,000 a year. what's more, most of the other enticing opportunities open to these students won't require them to incur $200,000 worth of student loans. that system, in my opinion, can be easily fixed. it can be fixed through, increased reimbursement by federal and state gove~ment, medicare and medi­ caid programs, and incentives around tuition for students who are willing to enter primary-care, and willing to follow through with that decision and then go locate in one of the medically underserved areas in the state of indiana. i also think that you could tweak indiana state's program. indiana state has a direct admit to medical school program for high school students, and many of those students start off wanting to go into primary-care. but, that program can't by 484 indiana health law review [vol. 5:463 itself resolve the shortage ofpcps, because students are free to choose another specialty at will once accepted to the medical school. we need to create some incentives to keep students interested in becoming pcps. we have to fix the system because right now the incentives just aren't there to encourage someone to go into that specialty. i was also kind of hoping we'd get into a discussion today about some of the growth and building of healthcare facilities and other things that is going on, not only in central indiana but around the state. one of the questions i ask every day as i drive by them, and i participate in the planning for some ofthern, is who's going to work in those facilities? we aren't going to have the nurses or the doctors to staff them. so again, we need to create incentives. lastly, i'd say that maybe we need to look at building an additional or second medical school in the state of indiana, a medical school that's maybe focused just on primary-care. my solution's to fix primary-care. those are just some easy ways to do it. dr. orentlicher: all right. let's tum to some questions from the audience. as we're struggling to achieve national healthcare reform we've seen states like massachusetts and maine step up. should the federal govern­ ment do more to support state healthcare reform initiatives? can it be done on a state-by-state basis or are there too many problems? specifically, with mas­ sachusetts' plan, will the uninsured flock to massachusetts? is there something that can be done at the state level? dr. buechler: i don't know much about this, and somebody here might know more. it's called the healthy indiana plan. fqhcs have social workers and they've been handing out applications like crazy to underserved people without insurance. it seems like people are very interested in a subsi­ dizedi think it's a highly subsidizedinsurance product. i don't know enough about it to discuss it in depth, but it seems to me that people that don't have insurance are very interested in the healthy indiana plan. just as dr. car­ roll said, there's no way they can possibly afford it. so an expansion of that plan might work. dr. carroll: i think that a state plan, if it was incredibly well done, could have great potential. i have to be honest. i don't think most of the state plans that have been put forth are necessarily going to accomplish their goals. they don't go far enough in my estimation, and in some sense the fact that they take half steps makes them less likely to succeed in some ways than doing noth­ ing at all. this is because a half step that increases costs and provides very lim­ ited benefits makes any attempted reform look impractical and economically unsound. additionally, there are a lot of problems associated with trying to imple­ ment healthcare reform at the state level. for example, what happens when people want to move from one state to another? how would they report their 2008] getting beyond ldeowgy to true reform 485 insurance? there are actually legal ramifications, which likely all of you are more expert in than i am, and they're not really all that different than the rami­ fications at the national level. so is it possible that partial state reform could succeed? yes, but i actually think it's probably less likely to succeed than the whole step of doing it at the national level. dr. orentlicher: okay. thank you. let's tum to the next ques­ tion. compensation seems to be one of the problems. specifically, there seem to be problems involved in compensating specialists more than primary-care physicians, and compensating for treatment rather than for prevention. the capitative compensation system pays providers to keep more patients healthy. in other words, the capitative compensation system pays a certain amount for each patient. that's all you have, and so it's in your best interest to keep them healthy, because the less treatment they need, the fewer dollars are required. why has capitation not been more successful? mr. gutwein: well, let me just offer perhaps a couple thoughts on that. i work in a system that is essentially capitated. i'll apologize upfront for shamelessly bragging about the system that i work in. i work at wishard health services. we're the second-largest state hospital system in the country, with over 1.2 million outpatient visits a year. we are essentially a capitated system because we get a fixed pile of money that we beg, borrow, and steal to collect. then we try to serve every patient that walks in our door. as a result, our incentives are precisely to serve each patient in the most effective, lowest­ cost way that we can. in other words, our incentives are actually precisely the opposite of most healthcare providers. most healthcare providers get paid every time they performthat's assuming they have a payera procedure on a person. therefore, every time they do a procedure they get more money in the door, so their incentives are to do as many procedures as they possibly can. conversely, we are incentivized to too make sure that patients become as healthy as they possibly can as quickly as possible, and to get them out the door so that someone else can come and fall into an empty bed in the middle of the night if they need to. it turns out that in our capitated system our cost per patient is in the nine­ tieth percentile in the country. in other words, ninety percent of the hospitals in the nation have a higher cost than we have. only ten percent have a lower cost, and that includes hospitals in nice suburban areas that have very highly­ educated and healthy patients. actually, our patient base is a pretty unhealthy patient base because we deal with people who have a lot of problems. i think the reason why we have such a high-quality and low-cost system is that we real­ ly do attempt to drive people to primary-care. we have a system that works very hard to ensure that as much primary­ care is provided as possible. by primary care, i mean care provided in a con­ tinuum that finds illnesses at the earliest possible moment, works with patients to give them preventive care, reduces the use of specialists, and keeps people 486 indiana health law review [vol. 5:463 out of the emergency room. all of those things drive down healthcare costs. so i think that our system, because we don't have an incentive to try to provide unnecessary care, provides a pretty good bang for the buck when you bench­ mark us nationally. now, capitated systems have been unpopular for the private insurance sys­ tem because managed care tries to tell people that they can't go to a doctor at a certain time even if they want to go and second-guesses the decisions of physicians and patients. managed care does this, in part, because we don't have a fully-integrated healthcare system that can serve as the capitated portion of the system. in other words, it works for us because we are both the payer and the provider. therefore, when we render medical care we focus on provid­ ing the lowest cost highest quality care for the patient. when the provider is not the entity that's capitated, but rather the payer, then a perverse incentive is created to try to actually eliminate care. that's why capitated systems, i think, have been extremely unpopular with all of the physicians who've been on the other side. the kaiser permanente system has actually been an awfully suc­ cessful system in terms of lowering costs and increasing quality. the kaiser permanente system is a system like ours where both the provider and the payer are in essence the same entity. so i think there's great promise with the capi­ tated system, but not with the kind of capitated system where the capitation is only at the payer level and not the provider level mr. schmitz: i'd have to agree with mr. gutwein on a lot of that. one of the things that you run into frequently is the notion that insurance com­ panies should own physicians. anthem got into this back when it was just in­ diana blue cross many years ago. back then we actually tried owning physicians. we failed miserably at it. we could not run a physician's office. conversely, one of the things that you'll see with capitated products is that phy­ sicians are excellent at what they do. they're excellent at rendering care and trying to get people back to a healthy state. they're not very good, however, at being actuaries, and i think that's why you run into difficult situations. another thing to consider is that you don't have a lot oflarge groups. i know there's been a lot of discussion throughout the day about the size of risk pools. as the size of a population increases, so too does the predictability of the costs associated with that population. this allows insurance companies to create better risk models. throughout indiana though, you probably could count on a couple hands the number of physician groups that have enough pcps or overall physicians in their group to take on the amount of risk that is necessary to affect the overall outcomes without really putting the groups them­ selves at risk financially. dr. orentlicher: other comments? okay. then let's turn to another question. what is the role of for-profit entities in healthcare? if they exist as a necessity for the free market to function, then how do for-profit insur­ ance companies justify vertical integration of pharmacy programs which also 2008] getting beyond ideology to true reform 487 limit competition in patient choice? are for-profit hospitals and other entities good or bad for our healthcare system? dr. carroll: obviously, we're all going to have different opinions on this topic. i personally think that it really isn't logical for for-profit organi­ zations to function in our healthcare system. let's be honest about how insur­ ance works, honest with no moral judgment. an insurance company makes more money by covering more healthy people and fewer sick people. it really only makes intuitive sense that the less money you have to put out, because your people are healthy, the more money you will take in, and the higher the profits you will make. any for-profit insurance company that disputes that analysis should really be talking to their shareholders, because that's obviously how they make money. whether it's good or bad, in order to make more money, insurers must to some extent cherry-pick their patients. you either have to go after the healthy people and not cover the sick people, or you have to try to limit what you cover so you're not putting out too much money. again, that's the reason you have to get a physical when you get insurance. that's why you have to provide a de­ tailed medical history, so that your insurer can see what your prior expenses were. that's how for-profit insurance works, and it's difficult to argue how it could work on a very large scale. if the for-profit insurance people are only going to cover the healthy peo­ ple, then the rest of us are stuck picking up the tab for the sick people, and that's what we're doing right now. we've got medicare and we've got medi­ caid. that means we're covering the extremely poor and the elderly, two of the sickest, most expensive populations in the united states. at this point, private insurance covers about two-thirds of the people in this country and actually pays for about one-third of the cost. that's how they make their money. the government covers about one-third of the people, the most expensive one third and pays for two-thirds of the cost. that's why they can't afford to reimburse very much. that's why it always looks like they're hemorrhaging. there's nothing inherently wrong with the government system, nothing inherently wrong with the way that medicaid and medicare work. they're just hampered by their expenses. look at it this way. i have private insurance, but every year my insurance rates go up. the medicare rates to some extent have been static since they were put in to effect. in essence, medicare charges you a fixed percentage of your pay check. they can't raise their rates. yet every year they're forced to cover more people because more people are reaching the sixty-five and above age bracket. they're forced to cover more costs and they continue to do it without raising their rates. but, private insurance gets to raise their rates whenever they want, and they can cover more and more healthy people each year. that's how they make their money. to try to integrate those two systems would be very difficult. they won't mesh. 488 indiana health law review [vol. 5:463 now, perhaps there are other models that would allow private insurers to make money on top of a national insurance system. that's how medicaid sup­ plements work. that's perfectly plausible. there is no way that both systems could be in direct competition with each other though. as long as private in­ surance companies are going to make money by covering healthy people, a pub­ lic system would find it impossible to function effectively at the same time. dr. buechler: i'd like to hear the answer from the largest profit­ making company in indiana (anthem/wellpoint). mr. schmitz: when i look at hospitals, whether they are referred to as not-for-profit or for-profit, i recognize the fact they're in business to stay in business. we don't want to see any of the not-for-profit hospitals that we deal with every day go bankrupt. we don't want to see them close their doors, or have an issue with regard to overall fmancing. we want to see our hospitals to stay in business. in regards to dr. carroll's comments, anthem has recently expanded its role. at one time, we did only offer commercial health insurance. if you look at some ofthe risk pools that we have today, however, you will see that we have some very tough customers. indiana's a highly-immunized state. there has been a lot of the smoking on the job. there are still factories out there with cigarette machines in their plants and employees that eat fast food every day. that hasn't stopped us. today, we serve the medicare population, two years ago we got into the medicaid population, and now we have recently gotten into serving the healthy indiana population. it's not about denying care. it's not about charging more to make a profit. what we've found is that employers, the state of indiana, and the federal government, come to private payers and say, "look, here is the overall risk. help us manage it. anthem, mdwise, and united, help us manage the overall risk. help us manage the care. help these patients get to the proper physician or provider. let's use the services prop­ erly." mr. gutwein was correct when he stated that consumer incentives like gift cards or other small incentives can be helpful. we use incentives a lot with our healthy indiana population. we use them with our medicaid population. we're managing the risk. we're helping these people get to their primary-care visits. we make sure that there are bus lines, and if they don't have the trans­ portation, we get them to their appointments so that we can reduce that overall long-run cost in care. so at the end of the day, whether you're for-profit or not­ for-profit, you're in business to stay in business. you can't stay in business and lose a lot of money. mr. gutwein: i work for a public hospital that is there to treat the in­ digent and to serve, so let me take a moment to defend the for-profit hospitals. to piggyback on mr. schmitz's point, i want to point out that the system we have right now requires payers, and principally insurance-carrying payers, to 2008] geiting beyond ideology to true reform 489 subsidize the healthcare delivery system for nonpaying patients. it's a system that mandates cross subsidization. in other words, if you put a hospital down­ town, we expect that hospital to serve every single patient, including a fair number of nonpaying patients, and all of us that have insurance are expected to subsidize those nonpaying patients. that creates for the business model and the healthcare provider the dilemma of how to stay in business when you have lots of nonpaying patients coming to you. every health care provider tries to manage what's called the payer mix. in other words, how many patients have medicare, how many have medicaid, how many have nice insurance cards, and how many are uninsured? and it turns out that perhaps the most effective way to manage your payer mix is geography. in other words, to put your hospital where the most payers are and the least non­ payers are. the second most effective way is to be a for-profit entity so that the government mandates don't apply to you, and you get to decide who comes into your hospital and who doesn't. and those facts are highly rational, predictable behaviors that result from the healthcare system that we have. it's precisely what you would predict will occur if you set up a system that has forty-seven million uninsured, then put in place laws that require every hospital that has an emergency room to treat every patient that walks through its doors. i don't believe that for-profit hospitals are run by morally bad people who are somehow trying to put one over on the rest of us. they're rational eco­ nomic actors that are reacting to a broken system that needs to be fixed. i think we need to provide universal coverage for everyone. that way we don't have the perverse incentives that lead to the construction of unneeded hospitals in suburbs and hospital flight from areas of high density where people have enor­ mous medical needs but lack access. it is a systemic problem to me, not an in­ dividual issue of moral blameworthiness focused on the owners and operators of for profit hospitals. so what i'm actually doingdr. carroll: just to be clear. i'm making no moral judgments. i said exactly the same thing; that this is how business operates. this is how in­ surance companies mr. gutwein: actually, i was agreeing with you completely, dr. carroll. dr. carroll: sometimes it's very easy to jump to the conclusion that a moral judgment is being made. i make no moral judgments. what we have both described is rational business decision making on the part of healthcare providers. that's how they make money. everybody agrees. i just don't think it's appropriate. dr. buechler: i want to apologize to mr. schmitz because i made a cynical comment earlier. in reality, i don't have a problem with for-profit in­ surance companies. i do think that they need to be much more transparent 490 indiana health law review [vol. 5:463 about what they are offering, to whom they are offering it, and under what cir­ cumstances it will be offered, so that there can be true competition out there. with big employers there is transparency, because they have people that ana­ lyze it. i do have a problem, same kind of a problem, though, with the for­ profit hospital system and the cherry-picking that definitely goes on, because it impacts all ofthe not-for-profits. but that's just our system. i can understand it. it just isn't good. dr. orentlicher: okay. mr. gutwein, did you want to complete your statement or respond? mr. gutwein: no. dr. orentlicher: ok. then let's turn to another question. my son is a physician. his wife is a nurse practitioner. for identical care she's paid a fraction of what he is. should we not be making better use of nurse practitio­ ners and nurse anesthetists? how much would that do improve our healthcare system? dr. buechler: well, i've had a lot of experience with mid-level pro­ viders, and i am a strong advocate of nurse practitioners and physician's assis­ tants, especially when they work in a collaborative practice. i have a bit of a problem with their independent practice based strictly on education. the edu­ cation is significantly different, but most of what you see in primary-care is calm and ordinary and can be taken care of by any well-educated person. should there be a discrepancy in payment? there should be a discrepancy. after all i went through eight years of education after college. but it should be slight. really, the only thing that is saving primary-care right now for hundreds of thousands of people in our country is mid-level providersthey're doing a good job but we should all be working collaboratively together. there are plenty of patients to go around. dr. carroll: it's interesting because the question really made me think about how it would fix the system. the question gives me pause only because it suggests that by fixing one aspect of the system, we're going to im­ prove everything at the same time, including cost, quality, and access. in reality though, it's pretty much impossible to lower costs, improve quality, and im­ prove access all at the same time. there are quite a few studies that show that if we get everybody in the country to stop smoking tomorrow the long-term health costs of this country will go up significantly. that's right, if everyone quits smoking our healthcare costs will continue to rise, because people are go­ ing to live longer. it's a good, but it's going to cost us money. conversely, i can drop the health care costs in this country tomorrow ifi kill everybody who's in a hospital today. that would not be a good, but it would reduce costs. 2008] getting beyond ideology to true reform 491 clearly, doing good, improving quality, and improving access are all go­ ing to cost money. access to mid-level nurse practitioners would improve ac­ cess immensely. would it improve quality? i don't know if it's been proven one way or the other. however, such access might improve the quality of pri­ mary-care generally. would it improve costs at the same time? i don't think so. more mid-level nurse practitioners would likely be able to see more pa­ tients, but i have no idea how much their training would affect the situation. it's very likely that it would improve quality and improve access at the sake of cost. is that fixing the system? that's for everybody to decide. you have to sort of prioritize your cost, quality, and access. but there is no magic bullet that would hit all three at the same time. mr. gutwein: one really final comment on this. interestingly enough, the pay differential between certain physician extenders and physicians is not that great anymore. i think it was commented that a new primary-care physician earns about $125,000 a year. these for-profit companies that have nurse in a box, the minute clinic, those places, they pay the good nurses $90,000 a year. so it's a relatively small differential now, which shows how valuable for the business model the nurse practitioner is. mr. speer: their use is somewhat additive. i certainly support the ap­ propriate use of physician extenders, but i think the key is collaboration. under the right collaborative circumstances, i think they have a very important role to play. there's just not that much cost difference between them anymore. they do create more access. i think studies also show that there's greater patient sat­ isfaction with interaction with some of the extenders. but the extenders are seeing fewer patients in a greater period of time, so it would make sense they'd have higher satisfaction. mr. schmitz: ifl can add one more comment along with that. well­ point and anthem were recently approached by a physician extender group to actually enter the business of doing deliveries outside of a hospital system. i'll be honest with you, we wrestled with this. it would improve access to care, but what about quality? is there a price worth paying for quality? i think dr. bu­ echler was right on the money when he questioned where we need to draw the line with regard to how much a physician extender can be permitted to do as compared to a physician. dr. orentlicher: this question kind of ties into one ofprofessor annas's points about denial of death. providing care for sick babies, especially premature infants that may require up to four months of inpatient care, is ex­ tremely expensive for medicaid and the rest of the healthcare system. what is the line that should be drawn on extraordinary measures for these babies? dr. carroll, i think you said it was eighty-five percent of the cost from twenty per­ cent of the population. how much of this is inappropriate? are we now draw492 indiana health law review [vol. 5:463 ing lines where they should be drawn? or is it just that chronic illness is very expensive? dr. carroll: that's an unbelievably excellent question, and if you think there's an easy answer, i can tell you that there just isn't. the problem is that right now our healthcare system is so fractured that there is no way to even begin to address that question. today there are differences in insurance, in coverage, in where patients live, in patient's access to the system in general, and in the fact that different hospitals can do different things. so we can't even begin to address the question. ideally, we'd like it to. i think that these are questions that we have to address as a nation. as we see health care costs spiral and go out of control, as we see quality start to go in the toilet, as the quality of our access to care continues to decline, we need to, as a country, make a decision about the way we want to spend our money. call it rationing if you will. there's a limited amount of money in the pot. there's only so much we can spend, and we have to decide where it's going to go. ide­ ally, these decisions should be made by a group of people from very different walks oflife. people, who come from various backgrounds, be they medical, legal, or ethical. we have to have groups that actually try to make these deci­ sions about how to spend money. other countries do this. we attack them for it. we tell them that they're rationing care and that they're sentencing people to die. but that's what happens when you start making these choices. you can only do so much. at this point we ration, to some extent, by insurance. if you have it, you have a good shot at getting the care you need. if you don't have it, you proba­ bly won't. you might if you're lucky. but that's how we ration right now. it makes a lot more sense to ration, if you want to use that word again, by some sort of ethical or guiding principles that we all come to terms with and agree on. we're probably going to have to do it someday as care gets more and more expensive, as drugs and procedures get more and more expensive, and as the incremental cost effectiveness of each new advance becomes smaller and smaller. is it an important question? yes, absolutely. are we going to have to draw the line somewhere at some point? yes, probably. but wouldn't it better to draw it in relation to a national system where we're all agreeing to it to­ gether, than for each of us just to roll the dice and hope for the best? mr. speer: we did $117 million in charity care last year in the state of indiana. my guess isand i don't have a precise figurea significant portion of that was dedicated to premature neonatal care for children. there is no bright line, and it's troubling to me that we would suggest there is a bright line. i'm unaware of any insurance product offered in this state that's ever prevented a child from getting needed care from wishard, st. vincent, clarian, or any other hospital. there are even neonatal transports in the state in all ninety counties that move a patient to exactly where they need to be. some of those children are in the hospital for months before they get to go home. i don't think 2008] getting beyond ideology to true reform 493 there's a bright line, and i don't think any child has been denied care from in­ surance. dr. carroll: let me make clear that i'm not implying there is. cer­ tainly i think we withhold prenatal care to some extent and that some people have better access to prenatal care, which can lead to prematurity. i absolutely agree, however, that i have never seen anyone withhold care. i'm a pediatri­ cian. i've never seen that bright line, nor do i think probably there is a bright line there. however, there has to be a line at some point. in some respect to our health care system, we have to come to terms with the fact that there's going to be a line somewhere for somebody. again, we can't spend unlimited money and at the same time achieve the best quality and the best access. the key is coming to terms with what's important. if we as a nation de­ cide that, yes, we want to spend as much money as possible on everybody then we're admitting upfront we're going to limit access and quality. and if that's what we agree to as a country, so be it. that's america, and i have no problem with that. but i think it needs to be a fair and open discussion amongst all of us, and that we all need to make that decision together. most people seem to be in agreement right now that we need to cover everybody. everybody at least needs access to the system through some type of insurance. again, i'm not implying that anyone's withholding care. i'm not imply­ ing that insurance is causing people to die, or not covering infants, or that peo­ ple don't care. i'm part of the system. we all drank the kool-aid. we all want to do "good." even healthcare providers that disagree with my stated po­ sitions completely are not evil. nobody wants to harm anybody. everybody wants to do "good." it's just a question of how to do the most good for the most people, and how to determine what our national priority is. mr. schmitz: i truly like this question, because the best way to save money in cases like this is to never have the case occur in the first place. that was what we were trying to talk about with regard to incentives around getting prenatal care. all of you are aware from the media that combinations of some cardiac drugs and viagra led to some pretty serious issues. the problem is that there's no data forum that cross-references these drug claims. we have a prod­ uct that will monitor and match up these claims so that we can alert a pcp if an adverse interaction is likely to result from some combination of drugs that have been prescribed. we also keep an eye out for situations where patients might need more information in order to make the best health related decisions. and when we think a patient or a physician needs assistance we get out there right away and we start working with them or we send them literature and informa­ tion. you spoon feed as much as you can, so that you never get into a bad situ­ ation. that's truly how we can prevent the most mishaps. dr. orentlicher: i want to ask just one more question. one ofthe things that we've seenand dr. john westbury and dartmouth are pioneering 494 indiana health law review [vol. 5:463 studies is the development of different practice patterns from one state to an­ other. even within a particular hospital, different doctors have very different practice patterns that are hard to explain. this is not based on patient differ­ ences. is that something that's unique to the u.s.? do you see this in other healthcare systems? is that something that would be addressed by changing to medicare for all? is it something that needs to be changed? how do we ad­ dress this problem? i think that one of the more recent examples of this phe­ nomenon is that the cleveland clinic does certain heart procedures for half the price of a nearby private clinic, and there's no good reason for the higher rate at the nearby clinic. is that being addressed? can it be addressed? is this a worldwide phenomenon, or is this particular to the u.s.? dr. carroll: !think that it's a problem that's probably not limited to the u.s. the difference between our country and other countries is to some extent an issue of accountability and transparency. in most other countries, the healthcare systems are more transparent. and because hospitals in those coun­ tries are not in competition with each other and not for profit there's a little more data sharing. the other consideration apparent here is that electronic medical records are big in other countries, so they have easy access to data. data that would take us years and millions of dollars to try to cobble together with wire and twigs in the u.s. other industrialized nations can, to some extent, pull up records regarding how many people in that country had a procedure in a particular area almost instantly. in the u.s., we have no way of easily accessing that type of informa­ tion. so in the u.s., it takes very time intensive and expensive studies to dis­ cover these differences, let alone begin to address them. also, if you only have one recordkeeping or healthcare system, it's a little easier, from the payer standpoint at least, to implement change, to say we're going to be paying for this procedure versus that one, going to shift to using this medication over that one. it's a lot more difficult in the u.s. because we have record keeping differ­ ences, not just amongst the various states, but also amongst hospitals in the sim­ ilar geographic areas. these inconsistencies will continue as long our system is not transparent. dr. orentlicher: okay. well, thankyouallforcomingtoday. this concludes our panel discussion. nathan a. bostick (corresponding author) mr. bostick is a staff researcher for the american medical association ("ama") ethics group where he develops policy reports on current topics in medical ethics. prior to his arrival at the ama, mr. bostick had served as policy analyst for agency for healthcare research and quality, and as a health economist with the research triangle institute, international. mr. bostick graduated with a master of arts degree in bioethics at the university ofvirginia in 2004 and a master ofpublic policy degree in health policy analysis from georgetown university in 2003. he previously completed a bachelor of arts degree in economics and psychology from guilford college. robert m. sade dr. sade specializes in cardiothoracic surgery and is based at the medical university of south carolina ("musc") in charleston, where he is a professor of surgery and has served as the director of the institute of human values in health care since its inception in 1995. he received his medical degree from columbia university college ofphysicians and surgeons in 1963 and completed his residencies in general surgery at boston city hospital, thoracic surgery at the deaconess and peter bent brigham hospitals, and pediatric cardiac surgery at boston children's hospital. dr. sade has written extensively on medical ethics and is engaged in the work of numerous committees for professional and medical societies; he currently chairs the ethics committee of the american association for thoracic surgery and the standards and ethics committee of the society of thoracic surgeons. he was elected to the council on ethical and judicial affairs in 2000 and elected vice-chair in 2005. john w. mcmahon, sr. after more than thirty years of active surgical practice in thoracic, vascular and general surgery in helena, montana, dr. mcmahon is currently the corporate medical director and principal clinical coordinator of the mountain-pacific quality health foundation. dr. mcmahon also serves as part-time general medical officer at shodair pediatric psychiatric hospital in helena. dr. mcmahon graduated from the st. louis university school of medicine in 1957, and completed a residency at st. louis university in surgery. prior to being elected to the council on ethical and judical affairs in 2004, dr. mcmahon served as president, ama delegate, and legislative chairman of the montana medical association. the american medical association council on ethical and judicial affairs the council on ethical and judicial affairs ("council,.) develops ethics policy for the american medical association ("ama .. ). the council consists of seven practicing physicians, a resident, and a medical student who are nominated by the american medical association's president and elected by the house. of delegates. with the assistance of a full time staff trained in medical ethics, the council maintains and updates the 160-year-old ama code of medical ethics, which is widely recognized as the most comprehen­ sive ethics guide for physicians. report of the council on ethical and judicial affairs: physician pay -for-performance programs* i. introduction physician pay-for-performance ("pfp") compensation arrangements attempt to provide an economic incentive to improve health care quality by linking remuneration to measures of individual, group, or organizational performance. these programs typically offer bonus payments to physicians who either meet, or demonstrate improvement in meeting, pre-established standards of performance measure. the american medical association ("ama") has issued a set of principles and guidelines that advocate for acceptable parameters.1 the ama states that pfp programs should strive to: ensure the quality of care; foster the patient/physician relationship; offer voluntary physician participation; use accurate and fair data reporting; and provide fair and equitable program incentives.2 many of these principles are closely related to core concepts of medical ethics and professionalism, including patient autonomy, conflicts of interest and trust, as well as fairness and justice. accordingly, this report examines the tensions that may arise from physicians' participation in pfp programs and offers guidance to physicians striving to practice ethically in the face of performance-based incentive arrangements. ii. background the past decade has been marked by an emerging quality movement in medicine, prompted by the institute of medicine's health care quality initiative, "crossing the quality chasm," which proposed a new quality construct based upon safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. 3 to achieve these objectives, key health care leaders have emphasized the role of evidence-based guidelines.4 * ceja report 3-i-05 presented by priscilla ray, m.d., chair, referred to reference committee on amendments to constitution and bylaws (charles j. hickey, m.d., chair). 1. am. med. ass'n, board oftrustees report 5-a-05: pay-for-performance principles and guidelines, http://www.ama-assn.org/meetingslpublic/annual05/bot5a05.doc (last visited may 17, 2006). 2. am. med. ass'n, principles for pay-for-performance programs, http://www.ama­ assn.org/amal!pub/upload/mm/368/principles4pay62705.pdf (last visited may 17, 2006) [hereinafter ama principles]. 3. seelnst.ofmed.,crossingthequalitychasm:anewhealtiisystemforthe 21st century (200 l ). 4. ama principles, supra note 2. 430 indiana healrn law review [vol. 3:421 in turn, this has led to the establishment of market-based quality improvement mechanisms that link compensation to measurements of patient safety and clinical outcomes. 5 among these, pay-for-performance programs provide participants with monetary bonuses to reward the achievement of predetermined quality or efficiency benchmarks.6 to measure performance, pfp programs must collect data on health care process and outcomes, including patient safety indicators and patient satisfaction.7 these data are then incorporated into payment mechanisms for hospitals or physicians. 8 physicians or physician groups, upon meeting a given program's performance criteria, are rewarded with modest financial bonuses that may constitute up to five percent of the total revenue received from a given health plan.9 iii. ethical responsiblities of physicians physicians are ethically obligated to provide competent, patient-centered care to each of their patients, as codified within principles i and viii of the code of medical ethics ("the code"). 10 physicians must also assume central roles in promoting patient safety by participating in the identification, reduction, and prevention of medical errors (see opinion e8.121, "ethical responsibility to study and prevent error and hann,"11 ama policy database). stemming from these obligations, physicians and the medical profession assume a duty to improve the safety and effectiveness of the health care that patients receive. 12 a. designing appropriate physician incentive programs compensation policies that are designed to promote optimal patient care, such as the incentives offered through pfp programs, represent one of 5. l. garcia, s. safriet & d. russell, pay-for-peiformance compensation: moving beyond capitation, 52 healthcare fin. mgmt. 52, 52-57 (1998). 6. ama principles, supra note 2; mary piette et al., integrating ethics and quality improvement: practical implementation in the transitional/extended care setting, 17 j. nursing care quality 35, 35-42 (2002). 7. bradley c. strunk & robert e. hurley, paying for quality: health plans try carrots instead of sticks, hsc brief no. 82, ctr. studying health sys. change (may 2004), http://www.hschange.com/content/675/ (last visited may 17, 2006). 8. ama principles, supra note 2; see also piette et al., supra note 6. 9. strunk & hurley, supra note 7. i 0. am. med. ass'n, principles of medical ethics, http://www.ama-assn.org/amalpub/ category/2512.html (last visited may 17, 2006) [hereinafter ama principles ofmedical ethics]. 11. am. med. ass'n, ethical responsibility to study and prevent error and harm, http://www.ama-assn.org/amalpub/category/11968.html (last visited may 17, 2006). 12. eran bellin & nancy neveloffdubler, the quality improvement research divide and the need for external oversight, 91 am. j. pub. health 1512, 1512-17 (2001). 2006] physician p4p programs 431 many measures intended to help physicians improve health care quality. 13 however, the establishment of financial incentives may also create unintended tensions for participating physicians, as well as for physicians in leadership positions. most notably, the presence of economic incentives risks establishing a conflict between physicians' financial interests and the fulfillment of their professional obligations. physicians' commitment to patient-centered care must supersede incentives offered by various compensation arrangements (see opinion e-8.03, "conflicts oflnterest: guidelines," 14 and opinion e-8.054, "financial incentives and the practice ofmedicine" 15). yet, all reimburse­ ment systems, including fee-for-service ("ffs"), capitation, and salary arrangements, establish various incentives that may adversely influence the quality of patient care. in fee-for-service, physicians are paid for each procedure or service that they provide to the patient. physicians have great latitude in providing necessary services, such as diagnostic tests or preventive services. 16 some may provide more services than are medically necessary, thereby promoting the over-utilization of medical resources.17 capitation plans pay physicians a fixed amount per patient over a given period of time, regardless of the quality or quantity of services rendered. while capitation has the potential to mitigate over-utilization, it creates an economic disincentive for the provision of expensive or complicated care, thus promoting underutilization. salaried arrangements that pay physicians a fixed sum may similarly contain costs, but also have the potential to lower productivity and discourage treatment of difficult clinical cases.18 in view of the shortcomings of all compensation methods, pfp programs may prove beneficial when they recognize and reward physicians who deliver optimal care to their patients. however, practicing physicians and physicians involved in the design and implementation of pfp programs must take appropriate measures to ensure that any incentives used by these programs are consistent with the ethical values of the profession. 13. inst. ofmed., supra note 3. 14. am. med. ass'n, conflicts of interest: guidelines, http://www.ama­ assn.org/amalpub/category/8469.html (last visited may 17, 2006). 15. am. med ass 'n,financiallncentives and the practice of medicine, http://www .ama­ assn.org/amalpub/category/8482.html (last visited may 17, 2006) [hereinafter ama financial incentives]. 16. sherman fouand, allen c. goodman, & miron stano, the economics of health and health care (3d ed. 2001 ). 17. thomas rice, physician payment policies: impacts and implications, 18 ann. rev. pub. health 549, 549-65 (1997). 18. bellin, supra note 12; gerald b. hickson et al., physician reimbursement by salary or fee:for-service: effect on physician practice behavior in a randomized prospective study, 80 pediatrics 344, 344-50 {1987). 432 indiana realm law review [vol. 3:421 b. responsibilities of physicians in leadership positions physicians with appropriate professional expertise should be integrally involved in the design, implementation, and evaluation of new pfp programs. 19 accordingly, physicians acting in this capacity should undertake efforts to ensure that any incentives and performance benchmarks established by pfp programs are designed to primarily benefit the patient and improve the quality of their health care, rather than promoting cost-containment (see opinions e-8.02 i, "ethical obligations ofmedical directors," 20 ande-8.054, "financial incentives and the practice of medicine" 21). c. responsibilities of practicing physicians physicians participating in pfp programs should work to ensure that the incentives provided by pfp programs preserve their ability to promote patient well-being. this may require negotiating the removal of any contractual terms that might compromise professional values, impede their ability to act as patient advocates, or obstruct the provision of medically necessary care (see opinion e-8.0501, "professionalism and contractual relations" 22). d. promoting evidence-based practice and preserving patient-centered care all physicians who strive to practice ethically are committed to the provision of competent patient care through the exercise of their professional expertise. however, due to differences in training and practice styles, equally competent and dedicated physicians may provide divergent treatments for like medical conditions. 23 this has led to system-wide variations in the use of medical services, medical expenses, and patient outcomes. 24 such inconsistencies in physician practice become ethically problematic when they prevent patients from deriving adequate benefits from medical care. to promote fairness, individual physicians must be sensitive to variations in 19. ama principles, supra note 2. 20. am. med. ass'n, ethical obligations of medical directors, http://www.ama-assn. orglama/pub/category/8468.html (last visited may i 7, 2006) [hereinafter ama ethical obligations]. 21. ama financial incentives, supra note 15. 22. am. med. ass'n, professionalism and contractual relations, http://www.ama­ assn.org/ama/pub/category/15457 .html (last visited may 17, 2006). 23. john e. wennberg et al., professional uncertainty and the problem of supplier­ induced demand, 16 soc. sci. med. 811,811-24 (1982); 24. mark r. chassin & robert w. galvin, the urgent need to improve health care quality: institute of medicine national roundtable on health care quality, 280 jama 1000, 1000-05 (1998). 2006] physician p4p programs 433 patient care that are not explained on the basis of medical need (see opinion e2.095, ''the provision of adequate health care" 25). collectively, physicians should implement quality improvement activities as a means of ensuring competent medical care and reducing unwarranted variations in patient outcomes.26 one such approach is the promotion of evidence-based practice guidelines, which define standards for the safe and effective delivery of medical care.27 pay-for-performance arrangements can strive toward this goal by establishing performance incentives· incorporating evidence-based practice guidelines. when doing so, the ama has advised that pfp programs should utilize current peer-reviewed evidence-based performance measures that have been accepted by physicians with appropriate practice expertise. 28 the benefit of practice guidelines resides in their promise to improve aggregate outcomes at the population-level. however, the adoption of practice guidelines is not intended to eliminate all practice variations. it should be noted that the degree of benefit derived from a given intervention remains variable at the individual-level due to patient-specific factors. moreover, over-reliance upon disease-specific practice guidelines can potentially diminish the quality of care delivered to patients with multiple comorbid conditions.29 for this reason, physicians must retain the ability to customize care for each individual in order to meet the specific needs of patients when participating in pfp programs. e. responsibilities of physicians in leadership positions physicians involved in the design and implementation ofpfp programs should contribute their professional expertise to ensure that the practice guidelines that are used are fair and objective, and consistent with the ethical values of the profession (see opinion e-8.021~. moreover, physicians working in this capacity must also ensure that all practice guidelines allow for sufficient variation to enable physicians to accommodate the specific needs of individual patients (see policy h-320.949, "clinical practice guidelines and clinical quality improvement activities" 31). 25. am. meci. ass'n, the provision of adequate health care, http://www.ama­ assn.org/amalpub/category/8429.html (1ast visited may 17, 2006). 26. inst. of med., supra note 3. 27. alan m. garber, evidence-based guidelines as foundations for peiformance incentives, 24(1) iiealthaff. 174, 175-79 (2005). 28. ama principles, supra note 2. 29. cynthia m. boyd et al., clinical practice guidelines and quality of care for older patients with multiple comorbid disease: implications for pay for peiformance, 294 jama 716, 716-724 (2005). 30. ama ethical obligations, supra note 20. 31. am. med. ass'n, clinical practice guidelines and clinical quality improvement activities, http://www.ama-assn.org/appslpf_ new/pf_ online (1ast visited may 17, 2006). 434 indiana healm law review [vol. 3:421 once evidence~based practice guidelines have been established. their designers have a responsibility to make these guidelines available to participating physicians, along with an explanation of any intended purposes and uses not related to patient care (see policy h-41 0.980, ''principles for the implementation of clinical practice guidelines at the local/state/regional level'' 32). if possible, pfp program designers should also inform practicing physicians of the expected benefits associated with specific evidence-based recommendations. 33 by doing so, the implementation of clinical guidelines can improve health care quality by helping physicians to select among multiple evidence-based recommendations in order to best benefit the individual patient.34 f. responsibilities of practicing physicians practice guidelines are ethically acceptable when they are primarily designed to promote.the well-being of patients. practicing physicians should familiarize themselves with current evidence-based findings and clinical practice guidelines that arise from them. this commitment is consistent with principle vofthe code, which directs physicians to "continue to study, apply and advance scientific knowledge [and] maintain a commitment to medical education" in order to serve patients in accordance with professional standards of excellence. 3s physicians also should share this knowledge with their patients in order to better inform patients' medical decision making and to improve their adherence to prescribed treatment (see opinion e-8.08, "informed. consent"36). physicians must not allow practice guidelines or performance­ based compensation arrangements to create unrealistic expectations among patients (see opinion e-6.01, "contingent physician fees" 37). therefore, physicians should inform patients that .evidence-based practice guidelines are based on clinical findings aggregated at the population level, meaning that individual treatment options and outcomes may vary in practice. physicians must also ensure that their focus on relevant practice guidelines does not inappropriately infringe upon patients' autonomy. 32. am. med. ass'n, principles/or the implementation of clinical practice guidelines at the local/state/regional~l. http://www.ama-assn.org/appslpf_ new/pf_ online (last visited may 17, 2006). 33. patrick j. o'connor, adding value to evidence-based clinical guidelines, 194 jama 741, 741-43 (2005). 34. h. gilbert welch et al., estimating treatment benefits for the elderly: the effect of competing risks, 124 annals internal men. 577,577-84 (1996). 35. ama principles of medical ethics, supra note 10. 36. am. med. ass'n, informed consent, http://www.ama-assn.org/ama/pub/category/ 8488.html (last visited may 17, 2006). 37. am. med. ass'n, contingent physician fees, http://www.ama-assn.org/ama/pub/ category/8364.html (last visited may 17, 2006). 2006] physician p4p programs 435 practicing physicians must inform their patients about the full range of available treatment options, as required by opinion e-8.053, "restrictions on disclosure in health care plan contracts." 38 physicians must then provide appropriate services in accordance with their patients' medical needs and personal preferences, even if such treatments conflict with the guidelines used to determine the physicians' performance.39 however, physicians are not ethically required to cater to all patient demands and may decline to deliver medical care that they do not believe has a reasonable chance ofbenefiting the patient (see opinion e-2.035, "futile care" 40). n. mitigating potential adverse impacts on pfp programs a potential ethical concern regarding the long-term effects of pay-for­ performance programs is the impact that these efforts may have upon patients' access to health care. should pfp programs publicize performance ratings or link physicians' compensation to patient outcomes without making appropriate case-mix adjustments, some physicians may be motivated to preferentially seek out and treat healthier patients.41 this practice allows physicians to improve their prospects for achieving pre-determined performance measures by treating only those patients presenting the best anticipated health outcomes. as this occurs, it may become increasingly difficult for some patients to access appropriate health care. the negative effects of patient selection could be especially problematic for patients belonging to vulnerable population groups. · patients from these groups tend to enter the health care system in more advanced disease states,42 and may be faced with limited fmancial and social resources or more severe communication difficulties, which can impede their ability to adhere to treatment recommendations.43 as a result, treatment outcomes for these patients may be sub-optimal. this may systematically disadvantage physi­ cians who treat patients from such vulnerable populations because their aggregate performance outcomes may not meet the benchmarks established by pfp programs. as a result, poorly designed pfp incentive structures could 38. am. med. ass•n, restrictions on disclosure in health care plan contracts, http://www.ama-assn.org/amalpub/category/8480.html (last visited may 17, 2006}. 39. louise c. walter et al., pitfalls of converting practice guidelines into quality measures: lessons learned from a va performance measure, 291 jama 2466, 2466-70 (2004). 40. am. med. ass'n, futile care, http://www.ama-assn.org!ama/pub/category/8389.html (last visited may 17, 2006). 41. e. haavi morreim, result-based compensation in health care: a good, but limited idea, 29 j.l. med. & ennes 174, 174-81 (2002). 42. kendra l. schwartz et al., race, socioeconomic status and stage at diagnosis for five common malignancies, 14 cancer causes& control 761,761-66 (2003). 43. rajesh balkrishnan, predictors of medication adherence in the elderly, 20 clinical therapeutics 764, 764-71 (1998}. 436 indiana iiealtii law review [vol. 3:421 dissuade physicians from serving wlnerable patient populations in favor of catering to comparatively healthier patients. in the face of such pressures, all physicians must uphold the mandates of principle j.x'4 and work to support access to medical care for all people. practicing physicians can promote equitable access by continuing to treat patients on the basis of need. in addition, physicians participating in the design and implementation of pfp progtams should ensure that these programs are structured in a way that does not discourage the treatment of patients belonging to vulnerable population groups. this can be accomplished by avoiding the use of performance benchmarks based upon factors beyond the control of individual physicians, by the incorporation of appropriate risk­ adjustment mechanisms, and through the use of risk-pooling strategies. 45 if pfp program administrators choose to make data on physicians' performance publicly available, physicians should advocate for the incorporation of risk­ adjusted performance ratings, characterized by adequate review and appeal mechanisms.46 v. conclusion physician pay-for-performance programs may benefit patients by improving the effectiveness and safety of medical care. these goals are consistent with physicians' obligations to provide competent patient care. however, physicians participating in these incentive programs must continue to uphold all ethical obligations to their patients and avoid conflicts of interest stemming from pfp arrangements. participating physicians must ensure that all care is delivered on the basis of patients' individual needs and preferences. physicians must also continue to treat each of their patients without bias and avoid further disadvantaging wlnerable patient populations. in addition, physicians should work collectively to ensure that the goals and incentives utilized by pfp programs promote patients' best interests. recommendations the council on ethical and judicial affairs of the american medical association recommends the following: physician pay-for-performance compensation arrangements should be designed to improve health care quality and patient 44. am. med. ass'n, principles of medical ethics, http://www.ama-assn.org/ama/pub/ category/2512.html (last visited may 17, 2006). 45. david a hyman & charles silver, just what the patient ordered: the case for result-based compensation in health care, 29 j.l. med. & ennes 170, 170-73 (2002). 46. am. med. ass'n, guidelines on pay-for-performance programs, http://www.ama­ assn.org/amallpub/upload/mm/368/guidelines4pay62705.pdf (last visited may 17, 2006). 2006] physician p4p programs safety by linking remuneration to measures of individual, group, or organizational performance. to uphold their ethical obligations, physicians who are involved with pfp programs must take appropriate measures to promote patients' well-being. (1) physicians who are involved in the design or implementation ofpfp programs should advocate for: (a) incentives that are intended to promote health care quality and patient safety, and are not primarily intended to contain costs; (b) program flexibility· that allows physicians to accommodate the varying needs of individual patients; (c) adjustment of performance measures by risk and case-mix in order to avoid discouraging the treatment of high-risk individuals and populations; (d) processes to make practice guidelines and explanations of their intended purposes and the clinical findings upon which they are based available to participating physicians. (2) practicing physicians who participate in pfp programs while providing medical services to patients should: (a) maintain primary responsibility to their patients and provide competent medical care, regardless of financial incentives; (b) support access to care for all people and avoid selectively treating healthier patients for the purpose of bolstering their individual or group performance outcomes; (c) be aware of evidence-based practice guidelines and the findings upon which they are based; (d) always provide care that considers patients' individual needs and preferences, even if that care conflicts with applicable practice guidelines; (e) not participate in pfp programs that incorporate incentives that conflict with physicians' professional values or otherwise compromise physicians' abilities to advocate for the interests of individual patients. 437 438 indiana heal til law review [vol. 3:421 .american medical association principles for pay-for-performance program physician pay-for-performance programs that are designed primarily to improve the effectiveness and safety of patient care may serve as a positive force in our health care system. fair and ethical pfp programs are patient­ centered and link evidence-based performance measmes to financial incentives. such pfp programs are in alignment with the following five ama principles: (1) ensure quality of care--fair and ethical pfp programs are committed to improved patient care as their most important mission. evidence-based quality of care measures, created by physicians, across appropriate specialties, are the measmes used in the programs. variations in an individual patient care regimen are permitted based on a physician's sound clinical judgment and should not adversely affect pfp program rewards. (2) foster the patient/physician relationship-fair and ethical pfp programs support the patient/physician relationship and overcome obstacles to physicians treating patients, regardless of patients' health condi­ tions, ethnicity, economic circumstances, demogra­ phics, or treatment compliance patterns. (3) offer voluntary physician participation-fair and ethical pfp programs offer voluntary physician partici­ pation, and do not undermine the economic viability of non-participating physician practices. these programs support participation by physicians in all practice settings by minimizing potential financial and technological barriers, including costs of start-up. (4) use accurate data and fair reporting--fair and ethical pfp programs use accurate data and scientifically valid analytical methods. physicians are allowed to review, comment and appeal results prior to the use of the results for programmatic reasons and any type of reporting. (5) provide fair and equitable program incentives-fair and ethical pfp programs provide new funds for positive incentives to physicians for their participation, progressive quality improvement, or attainment of goals within the program. the eligibility criteria for the 2006] physician p4p programs incentives are fully explained to participating physicians. these programs support the goal of quality improvement across all participating physicians. guidelines for pay -for-performance programs 439 safe, effective, and affordable health care for all americans is the ama's goal for our health care delivery system. the ama presents the following guidelines regarding the formation and implementation of fair and ethical pay-for-performance programs. these guidelines augment the ama's "principles for pay-for-performance programs" and provide ama leaders, staff and members with operational boundaries that can be used in an assessment of specific pfp programs. a. quality of care > the primary goal of any pfp program must be to promote quality patient care that is safe and effective across the health care delivery system, rather than to achieve monetary savings. > evidence-based quality of care measures must be the primary measures used in any program. 1. all performance measures used in the program must be prospectively defined and developed collaboratively across physician specialties. 2. practicing physicians with expertise in the area of care in question must be integrally involved in the design, implementation, and evaluation of any program. 3. all performance measures must be developed and maintained by appropriate professional organizations that periodically review and update these measures with evidence-based information in a process open to the medical profession. 4. performance measures should be scored against both absolute values and relative improvement in those values. 5. performance measures must be subject to the best-available risk­ adjustment for patient demographics, severity of illness, and co­ morbidities. 6. performance measures must be kept current and reflect changes in clinical practice. except for evidence-based updates, program measures must be stable for two years. 7. performance measures must be selected for clinical areas that have significant promise for improvement. > physician adherence to pfp program requirements must conform with improved patient care quality and safety. 440 indiana health law review [vol. 3:421 > programs should allow for variance from specific perfonnance measures that are in conflict with sound clinical judgment and, in so doing, require minimal, but appropriate, documentation. > pfp programs must be able to demonstrate improved quality patient care that is safer and more effective as the result of program implementation. > pfp programs help to ensure quality by encouraging collaborative efforts across all members of the health care team. > prior to implementation, pay-for-performance programs must be successfully pilot-tested for a sufficient duration to obtain valid data in a variety of practice settings and across all affected medical specialties. pilot testing should also analyze for patient de-selection. if implemented, the program must be phased-in over an appropriate period of time to enable participation by any willing physician in affected specialties. > plans that sponsor pfp programs must prospectively explain these programs to the patients and communities covered by them. b. patient/physician relationship > programs must be designed to support the patient/physician relationship and recognize that physicians are ethically required to use sound medical judgment, holding the best interests of the patient as paramount. > programs must not create conditions that limit access to improved care. (1) programs must not directly or indirectly disadvantage patients from ethnic, cultural, and socio-economic groups, as well as those with specific medical conditions, or the physicians who serve these patients. (2) programs must neither directly nor indirectly disadvantage patients and their physicians, based on the setting where care is delivered or the location of populations served (such as inner city or rural areas). > programs must neither directly nor indirectly encourage patient de­ selection. > programs must recognize outcome limitations caused by patient non­ compliance, and sponsors ofpfp programs should attempt to minimize non-compliance through plan design. c. physician participation > physician participation in any pfp program must be completely voluntary. > sponsors of pfp programs must notify physicians of pfp program implementation and offer physicians the opportunity to opt in or out of the pfp program without affecting the existing or offered contract provisions from the sponsoring health plan or employer. > programs must be designed so that physician nonparticipation does not threaten the economic viability of physician practices. 2006] physician p4p programs 441 > programs should be available to any physicians and specialties who wish to participate and must not favor one specialty over another. programs must be designed to encourage broad physician participation across all modes of practice. > programs must not favor physician practices by size (large, small, or solo) or by capabilities in information technology ("it"). (1) programs should provide physicians with tools to facilitate participation. (2) programs should be designed to minimize financial and technological barriers to physician participation. > although some it systems and software may facilitate improved patient management, programs must avoid implementation plans that require physician practices to purchase health-plan specific it capabilities. > physician participation in a particular pfp program must not be linked to participation in other health plan or government programs. > programs must educate physicians about the potential risks and rewards inherent in program participation, and immediately notify participating physicians of newly identified risks and rewards. > physician participants must be notified in writing about any changes in program requirements and evaluation methods. such changes must occur at most on an annual basis. d. physician data and reporting > patient privacy must be protected in all data collection, analysis, and reporting. data collection must be administratively simple and consistent with the health insurance portability and accountability act (hipaa). > the quality of data collection and analysis must be scientifically valid. collecting and reporting of data must be reliable and easy for physicians and should not create financial or other burdens on physicians and/or their practices. audit systems should be designed to ensure the accuracy of data in a non-punitive manner. (1) programs should use accurate administrative data and data abstracted from medical records. (2) medical record data should be collected in a manner that is not burdensome and disruptive to physician practices. (3) program results must be based on data collected over a significant period of time and relate care delivered (numerator) to a statistically valid population of patients (denominator). > physicians must be reimbursed for any added administrative costs incurred as a result of collecting and reporting data to the program. > physicians should be assessed in groups and/or across health care systems, rather than individually, when feasible. > physicians must have the ability to review and comment on data and analysis used to construct any performance ratings prior to the use of such ratings to determine physician payment or for public reporting. (i) 442 indiana heal til law review [vol. 3:421 physicians must be able to see preliminary ratings and be given the opportunity to adjust practice patterns over a reasonable period of time to more closely meet quality objectives. (2) prior to release of any physician ratings, programs must have a mechanism for physicians to see and appeal their ratings in writing. if requested by the physician, physician comments must be included adjacent to any ratings. :> if pfp programs identify physicians with exceptional performance in providing effective and safe patient care, the reasons for such performance should be shared with physician program participants and widely promulgated. > the results of pfp programs must not be used against physicians in health plan credentialing, licensure, and i or certification. individual physician quality performance information and data must remain confidential and not subject to discovery in legal or other proceedings. :> pfp programs must have defined security measures to prevent the unauthorized release of physician ratings. e. program rewards :> programs must be based on rewards and not on penalties. :> program incentives must be sufficient in scope to cover any additional work and practice expense incurred by physicians as a result of program participation. > programs must offer financial support to physician practices that implement it systems or software that interact with aspects of the pfp program. :> programs must finance bonus payments based on specified performance measures with supplemental funds. :> programs must reward all physicians who actively participate in the program and who achieve pre-specified absolute program goals or demonstrate pre-specified relative improvement toward program goals. :> programs must not reward physicians based on ranking compared with other physicians in the program. :> programs must provide to all eligible physicians and practices a complete explanation of all program facets, to include the methods and performance measures used to determine incentive eligibility and incentive amounts, prior to program implementation. :> programs must not financially penalize physicians based on factors outside of the physician's control. :> programs utilizing bonus payments must be designed to protect patient access and must not financially disadvantage physicians who serve minority or uninsured patients. emily a. benfer emily a. benfer is a clinical professor of law and the founding director of the health justice project at loyola university chicago school of law, beazley institute for health law and policy. the health justice project, a medical-legal partnership clinic, provides law students with an intensive, challenging education in the fundamentals of legal practice, systemic advo­ cacy and interdisciplinary collaboration necessary to becoming effective problem solvers and socially responsible, service-oriented attorneys. through highly effective quality representation to low-income clients, law students resolve the legal needs that underlie, exacerbate or could result in health disparity. professor benfer graduated cum laude from providence college with a b.a. in english and writing. after two years of service in the peace corps, which took her to zimbabwe, belize and thailand, and working as a law clerk at the new haven legal assistance association, inc., she began stud­ ying law. she received her ll.m from georgetown university law center and her j.d. from indiana university school of law, cum laude, where she was an editor of the indiana international and comparative law review, order of the barristers, and president of both the local and national equal justice works. during law school, she clerked for judge david hamilton, the lawyers • committee for civil rights, the indiana protective order pro bono project, and the washington legal clinic for the homeless. professor benfer has dedicated her career to serving the public interest. she received an arnold & porter equal justice works fellowship to implement the advocacy and litigation strategy that she designed in order to represent, and improve the district's response to, homeless families, children and youth. she then represented preschool aged children with disabilities in a successful class action against the district of columbia. as a staff attorney and teaching fellow in the georgetown university law center federal legislation and administrative clinic, she supervised and mentored law students, participated in the successful legislative campaign to pass the ada amendments act of 2008 and represented workplace flexibility 2010 in legislative advocacy involving low-wage workers, women in the workplace, family and medical leave, and the federal workforce. in recognition of her achievements, professor benfer was awarded indiana university's early career achievement award, the faculty prize (the only award bestowed at graduation), the equal justice works martindale hub­ bell exemplary public service award and the american bar association judy m. weightman memorial public interest award, along with numerous other commendations for her commitment to pro bono and public interest service. she has served on the equal justice works board of directors and national advisory committee, the district of columbia mckinney vento homeless assistance advisory board, the washington council of lawyers board of directors and executive committee and as a volunteer for the homeless children's playtime project. she is currently the faculty advisor for the norman amaker public interest and social justice law retreat, the chair of the american association of law schools poverty law section and a member of the society of american law teachers board of governors. the health justice project: a collaborative commitment to solving real world problems emily a. benfer • ' i. introduction •.........•••.....•••...••••..••••••.••••.••.•.••.•••.•••.••••......••••.••.•.. 523 ii. the health justice project: addressing real world health disparities in chicago ..•••..•.••.•.••..•...••.......•...•.••...••.••..........••.... 524 ii. the health justice project: mission and learning objectives •.•.•..••..••...•••...........•••....••••..•..•..•••••....•.•..•...•..........•..•.. 526 iii. the health justice project: effecting real change for real people ••••••.•..••••••••...••••...••.•..•••••.........••••...••••.....••......•.•..•.••. 528 n. conclusion .................................................................................. 530 i. introduction across the united states, low-income individuals, children and fami­ lies experience adverse health outcomes that are a direct result of their soci­ oeconomic status and environment. the following problems, which have devastating consequences for health, frequently emerge: food deserts1 that contribute to malnutrition and food .insecurity; substandard . housing that results in respiratory distress, lead poisoning and developmental delays among children; and trauma, such as domestic and community violence, that has been shown to lead to chronic illness and disability in adulthood? social determinants of health3 in turn affect an individual's capacity to * emily a. benfer is a clinical professor of law at loyola university of chicago school of law and the founder and director of the health justice project. professor benfer received her ll.m in advocacy from georgetown law center, her jd, cum laude, from indiana uni­ versity and her b.a., cum laude, from providence college. prior to joining the loyola facul­ ty, professor benfer taught iti the federal legislation & administrative clinic and trained in clinical teaching at georgetown law center. she practiced in multiple areas oflaw at legal services and public interest law organizations and assisted in the design of a medical-legal partnership in new haven, conn. she served as an equal justice works fellow at the washington legal clinic for the homeless and as a peace corps volunteer. 1. food deserts are areas that lack access to fresh produce, whole grains, milk. meat and other foods that make up the full range of a healthy diet. community food assessment, ctrs. for disease control & prevention, http://www.cdc.gov/healthyplaces/healthtopics lhealthyfood/community_assessment.htm (last visited may 8, 2012). 2. paul tough, the poverty clinic, new yorker, mar. 21,2011, at 25. 3. the world health organization defines social determinants ofhealth as: "the conditions in which people are born, grow, live, work and age, including the health system. these circumstances are shaped by the distribution of money, power and resources at global, national and local levels, which are themselves influenced by policy choices. the social determinants of health are mostly responsible for health inequities-the unfair and avoidable differences in health status seen within and between countries." social determi­ nants of health, world healm oro., http://www.who.int/social_determinants/en/ (last 524 indiana health law review [vol. 9:2 work or succeed in school, further exacerbating health and socioeconomic problems. to address the social determinants of health and improve health outcomes for low-income individuals and families in the community, the health justice project involves students and faculty of law, medicine, social work and public health to address health disparities in the community. ii. the heal1h justice project: addressing real world heal1h disparities in chicago the health justice project was developed to respond to an urgent and unaddressed need in the chicago community surrounding loyola universi­ ty chicago. local statistics reveal social inequalities that contribute to sig­ nificant deterioration of health among low-income populations. poor housing conditions are to blame for the 200/o of inner city children who be­ come sensitized to rodent allergens and develop asthma 4 as well as the es­ timates of more than 81,000 children being harmed by lead paint in illinois.5 an overwhelming number of chicagoans are part of the 24 mil­ lion low-income households in the united states that have to choose be­ tween a balanced diet or energy access.6 even if income were available, 609,034 chicagoans live in a food desert and are part of the 44 square miles lacking fresh produce or meat.7 more than 827,000 adults in lllinois have diabetes, 8 with the largest concentration in the humboldt park area of chi­ cago (the primary site of the health justice project).9 compounding the. health risk among low-income individuals is immi­ gration status. the state of illinois has one of the largest and poorest immi­ grant populations in the united states. these households are more likely to have legal problems than the average low-income household in illinois (fif­ ty-four percent compared to forty-nine percent of all low-income house­ holds ).10 yet, this population is less likely to seek out legal assistance or to apply for public benefits because they incorrectly believe that doing so will visited may 8, 2012). 4. municipal rodent management, ill. dep't of public health, http://www.idph. state.il.us/envbealtb/pcmunicipal_rodents.htm (last visited may 8, 2012). 5. frida d. fokum et al., the impact of lead: illinois lead program annual surveillance report 2008 (dec. 2009), available at http://www.idpb.state.il.us/ en­ vbealtb/pdf7lead_surv_rpt_08.pdf; chn.o law policy inst., benchbook on lead paint poisoning for the circuit court of cook county municipal division housing court 1-4 (2008), available at www.leadsafeillinois.orgluploads/documentslbenchbook.pdf. 6. adam sege, utility access and health 3 (june 2010). 7. jennifer wehunt, the food desert, cmcago magazine, july 2009, available at http://www.chicagomag.com/chicago-magazine!july-2009flbe-food-desert/. 8. diabetes prevention and control, ill. dep't of pub. health, http://www.idph. state.il.us/diabetes/index.htm (last visited may 8, 2012). 9. humboldt park diabetes task force, sinai urban health inst., http://www. suhichicago.orglresearch-evaluationlbumboldt-park-diabetes-task-force oast visited 20 i 0). 10. rob paral, the legal needs of immigrants in illinois: a report to the lawyers trust fund of illinois, http://www.robparal.com/downloadsllmmigrantll/o 20legal%20needso/o20report%2010-22-04.pdf(last updated oct. 22, 2004). 2012] health justice project: solving real world problems 525 make them ineligible for permanent residency and citizenship.11 the statistics demonstrate that members of the chicago immigrant community suffer poor health outcomes associated with low socioeconomic status, such as malnutrition, asthma, diabetes and lead poisoning, that could be addressed by members of an interdisciplinary team. the health justice project, which began as a law school clinic, quickly united the surrounding community, attracting partners from the medical, social work, public health and legal professions, including erie family health center,12 northwestern university family medicine residency program, 13 equip for equality, 14 lawyers' committee for better housing/ 5 and aids legal council of chicago.16 these community partners provide a wealth of expertise and knowledge necessary to overcome social, legal and systemic barriers to health. within loyola university chicago, health justice project partners in­ clude the school of law's beazley institute for health law and policy17 legal clinic (named, health justice project) and the school of social works' institute on aging and intergenerational study and practice. 18 in addition, the health justice project hosts loyola university masters of public health students who study the effect of the partnership on patient health and schweitzer fellows19 who select a discrete public health project in the community and collaborate with partners to develop solutions. for exam­ ple, one fellow is addressing food insecurity and food deserts in the low­ income community of englewood in chicago. all of the health justice project clients are patients of erie family health center, a federally qualified health center that has been serving chi­ cago's medically underserved communities for over fifty years. erie serves 11. kenzy v andebroek, opening doors to health care for immigrants and refugees 11 (sept. 7, 2006), available at http://www.cityofchicago.org/content/dam/city/ depts/cdph/policy ___planning!pp _ open%20doors%20to%20healthcare%20fof'llo20irmnigrant s%20and%20refugees.pdf. 12. erie family health ctr., http://www.eriefamilyhealth.org (last visited may 8, 2012). 13. nw. univ. family med. residency program, http://www.familymedicine.north westem.edu/residency (last visited may 8, 2012). 14. equip for equal., http://www.equipforequality.org (last visited may 8, 2012). 15. lawyers' comm. for beiter housing, http://www.lcbh.org (last visited may 8, 2012). 16. aids legal council of chicago, http://www.aidslegal.com (last visited may 8, 2012). 17. beazley institute for health law and policy, loy. u. chi. sch. of law, http://www.luc.edu/healthlaw/ (last visited may 8, 2012). 18. institute for aging and intergenerational studies and practice, loy. u. chi. sch. of social work, http://www.luc.edu/socialwork/intergenerational.shtml (last visited may 8, 2012). 19. the chicago area schweitzer fellows program, albert schweitzer fellowship, http://www.schweitzerfellowship.org/features/us/chi/ (last visited may 8, 2012). 526 indiana health law review [vol. 9:2 33,000 patients annually through 148,000 visits at 11 sites across chicago.z0 erie's patients are 68 percent female, 84 percent hispanic, 34 percent unin­ sured and 86 percent live below the federal poverty level.21 erie staff and healthcare providers are committed to serving low-income individuals and providing culturally competent care with compassion and respect.22 in ad­ dition, the majority of providers are faculty at the northwestern university feinberg school of medicine and understand the importance of investing in students. erie family health center also partners with the northwestern university mcgaw medical center to host residents from the northwestern family medicine residency program. this presents a unique opportunity to engage law, social work and public health students with residents, in ad­ dition to the front line medical providers. ii. the health justice project: mission and learning objectives the mission of the health justice project is to "overcome the social, legal and systemic barriers that prevent long-term health and stability for low-income individuals and families in chicago.'m to achieve the mis­ sion, students and professionals: 1. provide highly effective quality representation to low-income clients in order to resolve the legal needs that underlie, exacerbate or could result in health disparity. 2. provide law, medical, public health and social work students with an intensive, challenging education in the fundamentals of legal practice, systemic advocacy and interdisciplinary collaboration neces­ sary to becoming effective problem solvers and socially responsible, service-oriented professionals. 3. collaborate with other community members, advocates, and stakeholders in order to identify and eradicate the social, legal, and sys­ temic barriers that cause health problems among low-income individuals and families from an interdisciplinary and multifaceted approach. 4. create public policy to invigorate our community to overcome barriers to health. for the law students involved in the law school clinic component of the health justice project, the experience provides an opportunity to learn lawyering skills by connecting theory and practice through direct client in­ teraction and participation in the clinic. students participating in the clinic 20. erie family health ctr., 2010 annual report 5 (2010), available at http://issuu.com/eriefamilyhealthldocs/fylo. 21. /d. 22. see the erie promise, erie family health ctr., http://www.eriefamilyhealth. org!about-erie (last visited may 8, 2012). 23. welcome to the health justice project!, loy. u. cm. sch. of law, http://www.luc.edu/healthjustice (last visited may 8, 2012). 2012] health justice project: solving real world problems 527 may earn up to ten credit hours over four courses. the clinic courses em­ phasize the development of skills in interdisciplinary practice, client inter­ viewing and counseling,· fact finding and analysis, legal research and document drafting, pursuit of administrative and other legal remedies, poli­ cy advocacy and reform where appropriate, and creative problem solving for the benefit of clients. these skills are learned in the context of team­ work with an emphasis on collaboration and interdisciplinary problem­ solving. using this collaborative model, all clinic members are exposed to the range of cases handled in the clinic, terminology and culture of healthcare, and delivery of services to low-income people. students are encouraged to reflect on these experiences in developing lawyering skills, interacting with the social, justice and healthcare systems in which the cases originate, and realizing their own personal philosophy of lawyering. the learning objectives for the law students complement those of the medical residents involved in the health justice project through the north­ western family medicine residency program. residency program faculty designed a curriculum that is aimed at overcoming social determinants of health through an interdisciplinary health partnership. the learning objec­ tives include 1) work within an interdisciplinary team and demonstrate pro­ fessional behavior throughout the medical-legal partnership curriculum; 2) ability to successfully assess patients' needs by screening for unmet social needs and referring patients to an appropriate resource; and 3) ability to de­ scribe the ways in which social determinants of health present in patients. through the achievement of these objectives, residents meet multiple ac­ creditation council for graduate medical education milestones and core competencies, including patient care, medical knowledge, practice based learning, interpersonal and communication skills, professionalism, advoca­ cy and systems based practice.z4 residents encounter law and social work students during "precepting," didactics and grand rounds presentations, through direct requests for consultation and advice and through assigned interdisciplinary teams. similarly, the social work students, who are onsite as members of the law school clinic and supervised by school of social work faculty, collabo­ rate with the law students. they also engage in activities that meet the school of social work's learning objectives, including direct service, psy­ chosocial assessment of patients and clients, patient and client consultation, linking clients to community resources, evaluating the social services avail­ able in the community and developing resources. the public health students complete their practicum requirement through placement in the health justice project. the most recent public 24. michael g. stewart, core competencies, accreditation council for graduate med. eouc., http://www.acgme.org/acwebsite!rrc_280/280_corecomp.asp (last visited may 8, 2012). 528 indiana health law review [vol. 9:2 health student, supervised by a faculty member at loyola university chica­ go stritch school of medicine, investigated whether interdisciplinary health partnerships improve health outcomes and have a positive effect on social determinants of health. through adherence to partnership confidentiality and privacy rules, the public health student was able to access data collected through the partnership and id.terview clients served by teams of doctors, residents, law students and social work students. for students of every profession, these experiences are unparalleled: rm at the end of my frrst week back on the inpatient service, and with each patient that i see, i am sur­ prised by how much better i've become at connecting with them, listening to their problems, and responding with true empathy (my own way). there's such a . stark difference between the way i engaged patients in the past and the way i do today, and i owe a lot of that to lessons i learned last semester. i can already see that i'm a better doctor-to-be because of the experi­ ence i had with the health justice project. the clinic proved to be one of the most valuable and enriching educational . experiences at loyola. the health justice project made me a lawyer. i learned how to effectively advocate on behalf of clients. i learned how to write more persuasively. i learned how to think more critically-succeeding in identify­ ing legal issues and developing plans on how to · preempt and/or address client problems. i would like to report that this past semester was my most success­ ful academically, and i owe my improved perfor­ mance to the health justice project. the skills that i acquired in the clinic directly translated to my other coursework. the health justice project not only made me a lawyer-it made me a better law student. . the health justice project not only provides training and practice ex­ perience, but also exposes students to the dire need in their community and the realities of poverty and poor health. moreover, students realize the im­ portance of collaborating to achieve their goals. lll. the health justice project: effecting real change for real people since taking its first patient/client in 2010, the health justice project has served over 400 patients of erie family health center, contributed pro 2012] health justice project: solving real world problems 529 bono hours that are the equivalent of over two million dollars in attorneys' fees, and obtained reimbursement of medical expenses to erie family . health center after winning medicaid denial appeals. in the case of just one patient, the reimbursement was valued at over $25,000. to further the interdisciplinary partnership, students regularly train over seventy health care providers in the social determinants of health and work on interdisci­ plinary teams to address policy issues. together, they have commented on federal and local rulemaking related to public health, met with local policy makers and board of education members, worked with national non-profits, and visited capitol hill to educate legislators on the collaborative model. the students engage in creative problem solvin!(5 and devise innova­ tive approaches to their clients' legal issues. the following are examples of recent student accomplishments: preventing family homelessness. when the client's disability pre­ vented her from working and paying her rent, her landlord threatened her with a self-help eviction. after reviewing the landlord's actions, client's rental agreement and notices ofterinination, law students discovered multi­ ple legal violations. what was once a bleak situation, in which the client owed the landlord upwards of $2,800.00 and faced immediate homeless­ ness, was quickly reversed the student reached an unprecedented settle­ ment agreement, reducing the client's debt to $0, awarding her $1,200.00 in damages, and giving her 39 extra rent-free days in the apartment. social work students worked with the client to help her locate housing and sus­ tainable sources of income. ensuring access to heat and electricity. a client's health, that re­ quired an environment in which he could regulate his body temperature and refrigerate his medication, deteriorated when his utilities were disconnected. law students uncovered an unlawful utility shutoff practice on the part of a local utility company. in response, they negotiated with the utility compa­ ny, worked with partners to submit public comments to the lllinois com­ merce commission and letters to the editors of local papers in collaboration with medical partners. as a result, the students restored the client's utilities and ensured that others would not be subjected to similar actions. improving dangerous living environments. doctors immediately recognized the presence of social determinants of health when three siblings were diagnosed with lead poisoning, respiratory distress and other envi­ ronmentally induced ailments. to complicate matters, the landlord threat­ ened eviction because of the family's complaints. the law student 25. for summaries of recent cases handled by interdisciplinary teams, resources, and additional materials, please visit the health justice project at http://www.luc.edu/ healthjus­ tice or contact ebenfer@luc.edu. for an example of creative advocacy on the part of law, social work, and public health students, see meribah knight, homeless families walking a hard road, n.y. times, dec. 10, 2011, at a37, available at http://luc.edu/ bealth­ lawlhjplhjp_pdfs/homelessyamilies_ walk:ing_a_hard_road_-_nytimes.com.pdf. 530 indiana health law review [vol. 9:2 intervened, successfully defending against a retaliatory eviction. ultimate­ ly, when it became clear the condition of the unit was irreparable and too dangerous for the children, the law student helped the family break the lease without penalty, recoup their security deposit and move to a safer unit. the law student also positioned the family to bring a tort claim against the land­ lord for the harm to the children and their property. reducing poor health outcomes. a disabled client often met with her doctor after interviews with her caseworker at the department of hu­ man services ("dhs"). the doctor quickly identified the dhs meetings as the source of the client's exacerbated symptoms, including high blood pres­ sure and anxiety. the doctor, concerned that repeated visits could result in a medical trauma, suggested the client transfer dhs offices. when the cli­ ent's request was denied, law and social work students appealed the denial and successfully advocated for the transfer of the client to another dhs of­ fice, immediately resulting in stable blood pressure and reduced anxiety. law and social work students also address client's health problems by engaging in preventative work. oftentimes, public benefit applications, that could provide the income, food or housing crucial to the health of individu­ als and families, are difficult to complete and result in denials. for exam­ ple, when an elderly client's social security payments were garnished, making it difficult for the client to purchase food and medication, a law stu­ dent worked with the social security administration to reduce the garnish­ ment by half, increasing the client's income and ability to purchase necessities. students also assist clients in applying for social security ben­ efits. for one client, whose mental health disorder prevented him from completing the detailed forms required by the social security administra­ tion, jaw and social work students worked with doctors to help the client understand and complete the documents, resulting in an award of supple­ mental security income. similarly, students have successfully negotiated with subsidy providers, ensuring that the clients will continue to receive financial assistance despite the pending termination date. the result is the effective and optimal use of resources. by engaging members of disciplines that address the different and complex aspects of an individual's health (social, environmental, mental, physical), the model al­ lows for the transition from an acute care model to the whole patient model. it replaces episodic treatment with treatment of the root problem, even if the "treatment" is not necessarily medical in nature. as a result, the factors that contribute to repeat hospital visits are removed, reducing the utilization rate and allowing the physician time for the remaining patient panel. iv. conclusion the health justice project demonstrates how an interdisciplinary learning environment and collaboration between disciplines can improve patient health among low-income populations. it also brings students of 2012] health justice project: solving real world problems 531 law, social work, medicine and public health together in order to address the social determinants of health in the community, as well as prepare stu­ dents for the complex problems they will be called upon to solve through­ out their careers. interdisciplinary health partnerships provide an unparalleled opportunity to foster collaboration, improve community health outcomes and invest in students, the next stewards of public health and so­ ciety. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i robert f. rich robert f. rich is a professor of law, political science, medical humanities and social sciences, community health, and health policy and administra­ tion at the university of illinois at urbana-champaign. he is currently a "faculty fellow" in the office of vice chancellor for public engagement and institutional relations and director of the office ofpublic management within the institute of government and public affairs (igpa). he was the director of igpa from 1986 to 1997. in the 1993-94 academic year, he was on sabbatical leave in washington, d.c. at the johns hopkins university center for the study of american government; he was also a "special guest" at the brookings institution. in the 2002-03 academic year rich was the mercator professor at the humboldt university in berlin, germany where he has also been appointed as a permanent fellow in the european center for comparative government and public policy. in 2004, he was a visiting scholar at the max planck institute for foreign and international social law in munich. before coming to the university of illinois, rich was on the faculty of the heinz school of urban and public affairs at carnegie-mellon university (1982-86), the woodrow wilson school ofpublic and international affairs at princeton university ( 1976-82), the university ofmichigan institute for social research (1975-76), and the university of chicago (1974-75). he is the author of six books and over 50 articles in the areas of health law and policy, federalism, information policy, and science and technology policy. julian ziegler julian ziegler was born in 1978 in cambridge (uk), but spent most of his youth in germany. after graduation from high school in berlin in 1997 and obligatory military service, he joined the free university of berlin to study law. during his time as a student he worked part-time on a scientific project for ethical and legal issues of disease in the context of social health insurance, at the institute for ethics in medicine at the eberhard-k.arls-university of tiibingen. after graduation in spring of 2003 (1. state-examination), he was accepted as a visiting scholar by prof. rich at the university of lllinois at urbana­ champaign, college of law as part of the bmepiials exchange program, biomedical sciences exchange program-academic year program. for this research program he received a fellowship from the german academic exchange service (2003-2004). during that time (since january 2004), his dissertation project predictive genetic testing in health insurance, was accepted by professor kirchner (ll.m. harvard) at the humboldt-university ofberlin, law faculty. in summer 2004, he was awarded a ph.d. fellowship by the senate of the state berlin. currently, he is working on this dissertation project. genetic discrimination in health insurance­ comprehensne legal solutions for a {not so) special problem? robert f. rich • julian ziegler•• introduction in the course of the last decade, the technologies encompassing the field of human genetics have been constantly developed and improved. the most notable achievement was probably the completion of the human genome project (hgp) in 2003.1 along with the completion of the mapping of the human genome came the discovery that many diseases are gene-related, being either the effect of chromosomal aberrations, or monogenic or multifactorial diseases.2 currently, over 5000 gene-associated diseases have already been discovered, with the number increasing constantly.3 while this scientific progress offers great possibilities for the improvement of medical treatment, it also provides the possibility to analyze the dna of single individuals for forensic purposes or the diagnosis or treatment of medical conditions. in fact, predictive genetic testing is already possible for several gene-associated diseases, such as cystic fibrosis. 4 even though these tests are expensive, it is expected, the development of so called "gene-chips" or "dna-microarrays," which are capable of analyzing a large number of genes in one process, s will eventually lead to a significant decrease in cost. thus, in the near future these • professor of law and political science, university of illinois, and professor in the institute of government and public .aflhlrs. university oflllinois. b.a 1971, oberlin college; m.a 1973, ph.d. 1975, universityofchicago. •• dr.jur.-candidate, humboldt-university ofberlin, 2004-2005; 1. state-examination, free university berlin, 2003; visiting scholar at the university oflllinois, college of law, 2003-2004. (i would like to thank prof. dr. med. hilmar stolte from the international academy of life sciences (ials) and the biomedical sciences exchange program (bmep) for supporting this research project). i. press-release, national human genome research institute, international consortium completes human genome project: all goals achieved; new vision for genome research unveiled(sept. 30,2004),athttp://www.genome.gov/11006929(lastvisitedapr.16,2005)(on file with the indiana health law review). 2. see scientific appendix uifra part vi. 3. jennifer s. geetter, coding for change: the power of the human genome to transform the american health insurance system, 28 am. j. l. & med. i, 4 (2002). 4. see e.g., wylie burke, genetic testing, 347 n. eng. j. med. 1867, 1869 (2002). 5. memorandum by the senate commission on genetic research, predictive genetic diagnosis, scientific background, practical and social implementation, 23 (mar. 2003), availab/eathttp://www.dfg.de/aktuelles_pressejmlen_stellungnahmen/2003/download/predic­ tive _genetic_ diagnosis. pdf (last visited apr. 16, 2005) (on file with the indiana health law review) [hereinafter dfg]. 6 indiana health law review [vol. 2:1 tests could be affordable and available to the public at large. this develop­ ment is quite important for medical purposes, such as "paternity testing" or criminal investigations, and also for employers and the insurance industry. employers and insurance companies could use genetic tests in order to .screen out job or insurance applicants who have a genetic predisposition to develop specific fatal diseases. if costs could be decreased, then large scale testing of employees or individuals seeking health insurance coverage could become a supplement to common medical examinations and tests. consequently, the insurance industry might be interested in the use of genetic testing and genetic information in the process of underwriting. 6 this possibility is quite contro­ versial in the legal and public policy community. the use of genetic information by employers and insurance companies is far from being a mere utopian thought. this can be viewed both as an opportunity and a risk. in 1989, a study conducted by the u.s. congress office of technology assessment (ota) revealed that twelve fortune 500 companies were already using genetic monitoring or screening techniques to screen their employees. 7 in this context it is not surprising that law and public policy are concerned with "genetic discrimination;" indeed, the literature describes many examples of "genetic discrimination.'78 an example of this type of" discrimination" is well illustrated by theresa e. morelli's experience.9 her health insurance coverage was terminated because she had disclosed to her insurance company that her father suffered from huntington's disease. it is feared that employers might single out employees with a high risk of developing certain diseases in order to lower their health care expendi­ tures. 10 an additional concern is that health insurance companies offering coverage in the individual market might use predictive genetic testing as a means of underwriting, which could-in the case of an unfavorable test result -lead to an increased number of people who are virtually uninsurable because of their genetic risk profile.'' one could describe the primary fear of many 6. eric mills holmes, solving the insurance/genetic fair/unfair discrimination dilemma in light of the human genome project, 85 ky. l. j. 503, 539 (1997). 7. office of tech. assessment, u.s. cong., genetic monitoring and screening in the workplace, 171, 176 (1990); see also larry gostin, genetic discrimination: the use of genetically based diagnostic and prognostic tests by employers and insurers, 17 am. j. l. & men. 109, 117 (1991); jennifer krumm, why congress must ban genetic testing in the workplace, 23 j. legalmed. 491,495 (2002); kimberly a. steinforth, book note, bringing your dna to work: employers' use of genetic testing under the americans with disabilities act, 43 aluz. l. rev. 965,970 (2001). 8. krumm, supra note 7, at 496; gostin, supra note 7, at 117; robyn b. nicoll, long­ term care insurance and genetic discriminationget it while you're young and ignorant: an examination of current discriminatory problems in long-term care insurance through the use of genetic information, l3 alb. l.j. sci. & tech. 751, 752-53 (2003). 9. theresa e. morelli, genetic discrimination by insurers: legal protections needed from abuse of biotechnology, health span. sept. 1992, at 8. 10. jeremy a. colby, an analysis of genetic discrimination legislation proposed by the 105th congress, 24 am. j. l. & men. 443, 453-54 (1998). 11. /d. at 454-55. 2005] genetic discrimination in health insurance 7 authors as a fear of genetic discrimination.12 while most legal scholars have concentrated on the applicability oftitle i of the americans with disabilities act of 1990 (ada)13 and title vn of the civil rights act of 196414 to genetic discrimination in health insurance, neither act directly addresses this issue. the health insurance portability and accountability act of 1996 (hip aa), 15 represents the first health insurance nondiscrimination law, which partially deals with genetic information. although hip aa offers certain protections against discrimination based on genetic information, 16 these protections were not considered to be sufficiently protective, as the response of interest groups to more recent legislative proposals illustrates.17 therefore, the discussion about genetic discrimination in health insurance continued after the enactment of hip aa, and interest groups and associations called for new, more compre­ hensive legislation. consequently, several pieces of federal legislation con­ cerning genetic discrimination have recently been introduced.18 on october 14, 2003, one of those bills, the genetic information nondiscrimination act of2003 (gina), 19 was passed unanimously by the senate and is being actively considered by the house of representatives. it is worth noting, the president urged congress to enact gina, 20 and its passage by the senate has been widely applauded by lobbying organizations such as the american medical association (ama)21 and the american civil liberties union (aclu).22 thus, it is safe to assume that gina will not face further roadblocks on its way to become the first true federal genetic nondiscrimination law in the united states in this article, we argue the common legal conception of "genetic dis­ crimination" is fundamentally flawed. consequently, the current legal and public policy approach, based on this concept and reflected in the enactment ofhipaa and gina, is neither sound nor fully defensible. 12. kristie a. deyerle, genetic testing in the workplace: employer dream, employee nightmarelegislative regulation in the united states and the federal republic of germany, 18 comp. lab. l. j. 547, 555 (1997); krumm. supra note 7, at 491. 13. 42 u.s.c. §§ 12,111-12,117 (2004). 14. 42 u.s.c. § 2000(e) (2004). 15. 42 u.s.c. § 210 (2004). 16. see infra parts iv.b.l, iv.c.l. 17. see, e.g., infra notes 20-23. 18. see human genome project information, general privacy and legislation, at http://www.oml.govffechresources/human_genome/elsi/legislat.html (last visited apr. 16, 2005) (on file with the indiana health law review). 19. s. 1053, 108th cong. (2003). 20. press release, white house, president pleased with health insurance bill, (mar. 6, 2002)athttp:l/www.whitehouse.govlnewslreleases/2002103/20020306-10.html(lastvisitedapr. 16, 2005) (on file with the indiana health law review). 21. press release, yank d. coble jr., ama applauds senate passage of genetic information nondiscrimination bill, (ocl14, 2003) (on file with author). 22. press release, aclu, aclu urges house to move senate-passed bill prohibiting genetic discrimination, (apr. 1, 2004) at http:/lwww.aclu.org!privacy/privacy.cfin?id =15407&c=l29 (last visited apr. 16, 2005) (on file with the indiana health law review). 8 indiana health law review [vol. 2:1 hip aa and gina respond to fears of a "genetic determinism," which rely on incomplete information about the nature and invasiveness of genetic information. furthermore, genetic information as expressed and defined in the provisions of both statutes, is a concept that evades a precise definition; it is difflcult,·ifnot impossible, to distinguish it from regular medical information. nevertheless, both statutes provide differing defmitions of genetic information and try to distinguish between medical and genetic information. consequent­ ly, we conclude that hip aa and gina do not provide a clear statutory basis for legal decisions concerning discrimination based solely on the use or application of genetic information. the language of these statutes stems from a biased public policy conception of genetic information, which seems to be based on a misperception or misunderstanding of genetic testing methods and the empirical results derived from such testing. the current statutory approach also.neglects the legitimate information needs of the private health insurance market. the common fear of health insurers seems to be that if genetic test kits become widely available, adverse selection resulting from an asymmetry of information could occur. in turn, this could eventually lead to an increase in the pricing of health insurance policies and consequently lead to a higher number of people without health insurance coverage. in order to support our arguments, we will analyze the potential influence of hip aa and gina on genetic discrimination in private health insurance. in the frrst part of this article we analyze what is meant by the term "discrimination." we will examine the scientific basis underlying the concept of ''genetic discrimination" in order to pinpoint what exactly makes "genetic discrimination". different from "normal" discrimination in health insurance. the second part of the article focuses on whether genetic discrimination, as described in the first part, is likely to occur and if so, in which market segment. the third part examines protections against genetic discrimination in health insurance offered by the ada and executive order 13,145. in the fourth part, the impact of hip aa and gina on "genetic discrimination" in health insurance will be analyzed. since the idea of"genetic discrimination" is rooted in the definition of genetic information, we will examine the various meanings of the term "genetic information" provided by hipaa, the hipaa final interim regulations, and gina. we will show that hip aa and gina do not even offer comprehensive protection against "genetic discrimination", as defined by the laws themselves. the fifth and final parts of the article present our overall conclusions. i. what is unfair "genetic discrimination" in health insurance? in order to analyze the influence ofhip aa and gina on unfair "genetic discrimination" in the market for health insurance, it is imperative to under­ stand what the term "genetic discrimination" actually means. as "discrimina­ tion" is widely used to describe a behavior that is perceived in a negative fashion, it is important to emphasize the difference between this kind of 2005] genetic discrimination in health insurance 9 "negatively connotative" discrimination on the one hand, 23 and insurance discrimination on the other hand. despite the semantic difficulties in the use of the term "discrimination," the legal view of discrimination is founded in the fourteenth amendment to the u.s. constitution. in section 1, the fourteenth amendment provides for a general legal framework of appropriate and inappropriate differentiation.24 under the fourteenth amendment, "[ c ]lass legislation, discriminating against some and favoring others, is prohibited, but legislation which, in carrying out a public purpose, is limited in its application, if within the sphere of its opera­ tion it affects alike all persons similarly situated, is not within the amend­ ment "25 thus "it is only invidious 'discrimination' which offends the con­ stitution.''26 given this foundation, the issue is, how one differentiates between • permissible and invidious discrimination. the rules which are used to deter­ mine that question are summarized in lindsley v. natural carbonic gas co.,27 whereby a differentiation is unconstitutional if it is without any reasonable basis and therefore purely arbitrary. the court also developed another stand­ ard which stipulates that "the classification must be reasonable, not arbitrary, · and must rest upon some ground of difference having a fair and substantial relation to the object of the legislation, so that all persons similarly circum­ stanced shall be treated alike.',zs therefore, the core principle of the legal definition of unlawful (e.g. unconstitutional) discrimination is that similarly circumstanced individuals have to be treated alike in the absence of a reasonable basis for a differentiated treatment. since insurance discrimination is legally permissible, only as long as it is based on reason and not purely arbitrary, we will at first explain the use of 23. for an example of the derogatory connotation of the term "discrimination" see oxford advanced learner's dictionary, at 343: "treating a person or group differently (usually worse) than others .... "(anthony p. cowie et al. eds., oxford university press, 1989). 24. the constitutional language of the fourteenth amendment only focuses on whether a state statute conforms to the constitution; see cbs v. democratic nafl comm., 412 u.s. 94 (1973). although it is the fifth amendment which offers the due process clause in regard of federal action (such as the enactment ofhip aa and gina), unlike the fourteenth amendment, the fifth contains no equal protection clause and it provides no guaranty against discriminatory legislation by congress; see detroitbankv. united states, 317u.s. 329,337 (1943). thus, the "equal protection of the laws" is a more explicit safeguard of prohibited unfairness than "due process" oflaw; see bollingv. sharpe 347 u.s. 497,499-500 (1954). thus, it is the fourteenth amendment that has to be employed in order to illustrate the legal idea of wrongful discrimination. 25. barbier v. connolly, 113 u.s. 27, 32 (1884). 26. ferguson v. skrupa, 372 u.s. 726, 732 (1963); see williamson v. lee optical co., 348 u.s. 483,488-89 (1955). 27. lindsleyv. natural carbonic gas co., 220u.s. 61,78-79 (1911); moreyv. doud, 354 u.s. 457, 463-64 (1957) (stating that classifications which are purposefully discriminatory fall before the equal protection clause without more); e.g., barbier, 113 u.s. at 30; yick wo v.hopkins,118 u.s. 356, 373-74(1886);cf.newyorkcitytransitauth. v. beazer,440u.s. 568,593 (1979). 28. f.s. royster guano co. v. virginia, 253 u.s. 412, 415 (1920); see also brown­ forman co. v. kentucky, 217 u.s. 563, 573 (1910). 10 indiana health law review [vol. 2:1 discrimination in health insurance. next, we will analyze if the insurers' use of genetic testing procedures justifies a different legal treatment of genetic discrimination in insurance . . the health insurance market in the united states is divided into several mark~ segments. according to the u.s. census bureau, in 2002, 84.8%ofthe american population had health insurance coverage.29 that left 15.2% of the population (43,574,000 people) without health insurance coverage. approxi­ mately, 25.7% of the insured population was covered through government issued health insurance, such as medicare, medicaid and military health care. the remaining 69.6% of the population received health care through private health insurance, either employment based or individually purchased. 30 . since eligibility for governmentally issued health insurance coverage is not based on the applicants' health status, this market segment is not likely to be affected by genetic discrimination. private health insurance, in contrast to governmentally subsidized plans, is financed solely by individuals seeking coverage, such as employers, employees and private individuals. in this market segment, health insurers commonly use medical information for under­ writing purposes, which is fully permissible. on the one hand, insurance companies ask for the family history of applicants in order to determine if any hereditary disease is likely to manifest itself in the person of the applicant.31 on the other hand, medical examinations are conducted in order to screen out already manifest diseases. 32 usually health insurance is obtained as an employment benefit. in 2002, roughly 85% of the privately insured american population (175,296,000 of 198,973,000 people) received health insurance coverage through employment in policies written for large groups.33 this means that most medical insurance coverage is provided on a group basis and financed jointly (in some "shared arrangement") by employers and employees. the insurance industry classifies the risk of such groups based on a group's size, on its past claims experience or on data of the claims experience of similar groups in the same industry or 29. u.s. census bureau, u.s. dep't of commerce, healtiiinsurance coverage in tile united states: 2002, 20 (2003), available at http://www.census.gov/prod/2003pubs/ p60-223.pdf. 30. id. at 20 (in the author's opinion, the discrepancy between the total ofinsured people and the sum of governmentally and privately insured people is apparently due to overlapping coverage, such as medigap ). 31. david j. christianson, genetic testing: risk classification and adverse selection, 15 j.ins. reo. 75, 76 (1996); colby, supra note 10, at 462; deborah a. stone, the rhetoric of insurance law: the debate over aids testing, 15 law & soc. inquiry 385, 389 (1990) [hereinafter rhetoric]. 32. christianson, supra note 31, at 76; colby, supra note i 0, at 462. 33. u.s. census bureau, u.s. dep't of commerce, heal til insurance coverage in tile united states: 2002, 20 (2003), available at http://www.census.gov/prod/2003pubs/ p60-223.pdf. 2005] genetic discrimination in health insurance 11 region.34 the group's premium rates are also set according to these factors.35 since the risk incurred in employment-based health insurance plans is spread among the whole group, premium rates can be maintained at a relatively low price level.· furthermore, employer sponsored group health plans are usually subsidized by the employer.36 because of these subsidizations, the pricing of the group's policy does not increase due to high claims experiences, which may occur if many high-risk individuals are enrolled in the plan. as this subsidization practice helps to maintain stable premium rates, low-risk indivi­ duals are also attracted to enroll in the policy. consequently, the same average number of low-risk and high-risk individuals are attracted by the stable premium rates. 37 as employment-based group health insurance plans are experience rated, individual insurance underwriting practices are not used in calculating the group's premium rates. the risk of individuals can be spread among the whole group. this is only different in small group health plans with less than twenty­ five employees. 38 when the group size is too small to qualify for experience rating, the individual underwriting practices are used.39 given the rate-setting practices just described, health-status related information is of no actuarial value in the larger group market where underwriting practices are not used. consequently, any attempt to obtain and use such information for underwriting in this market segment should be considered both unnecessary and unfairly discriminatory. in contrast to employment-based large group health plans, small group health plans and individual insurance plans are underwritten in order to cal­ culate appropriate, i.e. actuarially fair,40 premium rates. risk-classification is one method utilized in the underwriting process. risk-classification enables insurers to divide individuals into groups with similar projected claims and obtain an estimate of the projected costs associated with an individual.41 thereby, insurers are able to calculate the lowest premium rates compatible 34. holmes, supra note 6, at 534. 35. id.; geetter, supra note 3, at 45. 36. national conference of state leoislatures, genetics poucy report: insurance issues 12 (2001 ). 37. id 38. deborah a stone, thestruggleforthesoulofhealthinsurance, 18j.heal1hpol., pol'y & l. 287,302 (1993); rhetoric, supra note 31, at 390. 39. geetter, supra note 3, at 45; stone, supra note 38, at 302. 40. geetter, supra note 3, at 49. 41. christopher m. keefer, bridging the gap between life insurer and consumer in the genetic testing era: therfproposal, 741nd.l.j.l375, 1383(1999);marcelitac.anderson, genetic testing in insurance underwriting: a blessing or a curse? an examination of the tension between economics and equity in using genetic testing in risk classification, 25 creighi'onl.rev. 1499, 1510(1992); christianson, supra note 3l,at75; roberta b. meyer, general position of the american council of life insurance on genetic information and genetic tests and life and disability income insurance, 15 j.ins. reg. 66, 67 (1996). 12 indiana health law review (vol. 2:1 with the projected costs (reasonable discrimination). furthermore, risk­ classification allows insurers to offset the impact of adverse selection.42 consumers, when faced with different insurance plans, must weigh the premium rates against the value they expect to receive. if the insurance applicant has critical information about his or her health status which is unknown to the insurer, this asymmet:iy of information might lead to insurance becoming less affordable. because high-risk individuals would be more likely to buy insurance, the insurer would be forced to eventually raise the premium · rates to cover the losses, which occur due to the higher claims costs. with increasing premiums, low-risk individuals would discontinue the plan, which , would lead to a further increase in premium rates to keep the plan balanced.43 this process, which can result in cases of asymmetric information, is called adverse selection. 44 by contrast, a situation of asymmetric information is not likely to occur if applicants disclose all relevant information to insurers. thus, the possibility of adverse selection could be offset and premium rates could be stabilized through fair risk classification. as mentioned above, insurers differentiate among individuals seeking health insurance coverage. the pwpose of this practice is maintaining a system in which each insured person's premium is rated according to the amount of his or her risk. implementation of this notion of actuarial fairness requires that insurers are allowed to create classifications that represent real differences between individuals. in order to stay in business, insurers must be allowed to risk-classify, which means, that they must be allowed to dis­ criminate or distinguish among individual health insurance applicants. because the private health insurance system covers nearly seventy percent of the american public without discrimination through risk-classification, the cornerstone of health insurance in the united states would be endangered.45 although discrimination is important in the health insurance market, it is necessary to distinguish between reasonable, legally permissible discrimina­ tion, which is vital to the health insurance market, and discrimination that is not. the legal permissibility of insurance discrimination depends upon its foundation of "reason," which in this case refers to medical, clinical, or statistical data about the insurance applicant. therefore, in the absence of this reasonable basis, insurance discrimination would be arbitrary and, thus, unlawful. 42. christianson, supra note 31, at 75. 43. george a akerlof, the market for "lemons": quality uncertainty and the market mechanism, 84 q. j. econ. 488, 492-93 (1970). 44. id. at 493; keefer, supra note 41, at 1384; holmes, supra note 6, at 543; anderson, supra note 41, at 1511; kimberley nobles, birthright or life sentence: controlling the threat of genetic testing, 65 s. cal. l. rev. 2081,2089 (1992). 45. holmes, supra note 6, at 535 (stating that without risk classification, the insurance system will cease to be a private insurance system). 2005] genetic discrimjnation in health insurance 13 reasonable legally permissible discrimination and unreasonable dis­ crimination can also be described as fair and unfair discrimination. 46 in deter­ mining unfair discrimination, it is important to analyze whether insurers' use of genetic information for underwriting purposes justifies a substantially different legal treatment than common methods of risk-classification in the process·ofinsurance underwriting. as genetic discrimination arises from the "discriminatory'' use of genetic information, we will examine the sources of this kind ·of information; genetic defects, gene-associated diseases, and the scientific and clinical methods used to detect them. in an effort to determine what is "reasonable," we will briefly explain genetic defects and the testing methods used to identify such defects. a. the nature of diseases from a legal perspective, in order to define "genetic information" it is essential to understand the role of genes in the development of diseases. if a person has a genetic defect, this defect can cause the development of a certain disease. while certain genetic defects translate into various diseases, others do not in some cases, the presence of a particular genetic defect is connected to the inevitable development of a disease associated with that defect.47 in most cases though, this relationship is more complex. there are three large and heterogeneous groups of gene-associated diseases: (1) monogenic diseases, which are caused by defects affecting a single gene;48 (2) polygenic-multifactorial diseases, which stem from the inter­ action of one or more genes and environmental factors;49 and (3) chromosomal aberrations, which are due to a change in the structure or number of the chro­ mosomes. 50 these diseases, and the genetic predisposition to develop such diseases, can be discovered or diagnosed by several differing methods. the most widely recognized method in this context is the so called gene-analysis. b. gene-analysis depending on the underlying pwpose of gene-analysis, several differing definitions of"gene-analysis" are offered. 51 in the insurance industry, obtain­ ing information about the "genetic" health-status of applicants or enrollees is the basis of underwriting, and thus, should be the basis for the definition of the term "gene-analysis" in this paper. thus, "gene-analysis" should be inter­ preted to include all methods that reveal information about the genotype of an 46. keefer, supra note 41, at 1384; colby, supra note 10, at 459. 47. dfg, supra note 5, at 25. 48. see scientific appendix infra part vi. 49. see scientific appendix infra part vi. 50. see scientific appendix infra part vi. 51. see, e.g., burke, supra note 4, at 1867; nicoll, supra note 8, at 756-57. 14 indiana iiealm law review [vol. 2:1 individual. as such, the term ''gene-analysis" encompasses four levels of analysis with several analytical techniques at each level. methodologically, two types of genetic tests can be distinguished: a) the direct genetic test, which tries to identify one or more disease-associated mutation(s); and52 b) the indirect genetic test, which tries to identify the risk-haplotype. 53 both direct and indirect testing methods have methodological problems associated with them. the direct test requires the identification and at least partial characterization of the relevant gene. 54 the other method, the indirect gene-analysis, uses the principle of genetic linkage. relying on the use of cloned deoxyribonucleic acid (dna) segments exhibiting sequence variability (polymorphism), which reside near a disease-associated gene, the method is used to track a chromosome carrying the disease-associated gene through a family. 55 the goal is to predict whether an individual in the family is likely to inherit the disease-associated gene. 56 the accuracy of this testing method depends on the informativeness57 of the individual's family for the considered gene loci, as well as the proximity of the marker genes to the disease gene locus on the chromosome. 58 as the list of known disease-associated genes grows rapidly, the direct testing method is of greater relevance for insurance companies. this is because the indirect testing method requires additional medical information concerning the family of the tested individual which may or may not be forthcoming. information about an individual's genotype can be derived using four different analytical approaches: (1) phenotype-analysis; (2) cytogenetic analysis; (3) protein-chemical analysis; and ( 4) dna-analysis. 59 in phenotype­ analysis, the outward appearance of an individual, the phenotype, is examined in order to reach conclusions concerning certain genetic traits of an individual. in cytogenetic analysis, abnormalities in the number or structure of the chromosomes are examined by the use of microscopic techniques. the protein-chemical analysis is an examination method by which one tries to discover gene-associated diseases linked to the presence, absence, or alteration of proteins, which can lead to metabolic defects. in contrast to the three pre­ ceding methods, the dna-analysis tries to discover genetic defects by examin­ ing the dna itself. if a genetic defect is known to be associated with the 52. h. william taeusch et al., schaffer and avery's diseases of the newborn 102 (lisette bralow ed., 6th ed. 1991). 53. id. 54. id at 101-02. 55. id at 102. 56. id. 51. margaretw.1ilompsonet al.,1ilompson & 1ilompson: genetics in medicine 180 (martin j. lawrence ed., 5th ed. 1991). 58. id. 59. for more information on the described methods of gene-analysis, see scientific appendix infra part vi. 2005] genetic discrimination in healm insurance 15 development of a certain disease, it is possible to estimate the likelihood of the development ofthis disease, if the genetic defect is present. dna-analysis, therefcn-e, does not predict the development of a disease. it only serves as a means :to discover whether a genetic defect is present or not. the ''penetrance," the likelihood of the development of a certain disease due to a genetic . defect, differs according to whether the disease is monogenic or polygenic-multifactorial. 60 except for the dna-analysis, all these methods are commonly used in regular medical examinations and only use different strategies in uncovering genotype-related information. c. is genetic information different? as summarized above, the methods used to unveil genetic information are not, from a scientific perspective, fundamentally different from the methods used in gathering other medical information. one could say that all medical information has a genetic basis. 61 as already indicated, genetic information can be derived by various methods, which are commonly used during regular medical examinations. phenotype-analysis, for example, can provide information about an individual's genetic makeup and is part of every routine medical examination. cytogenetic analysis and protein-chemical analysis are commonly used in the diagnosis of hereditary diseases. thus, the only ''new" form of gene-analysis is the dna-analysis. although the basic techniques used in dna-analysis were developed before 1990, dna-analysis is not widely used in medical examinations. this is primarily because of the laborious, and thus, expensive character of this technique, rather than because of its "exceptional" or ''unusual" character. therefore, even dna-analysis cannot be labeled a truly "new'' or ''unusual" form of examination that has to be regarded as strictly set apart from the other methods of gene-analysis, which are already used during regular medical examinations. consequently, we conclude the methods used in gathering genetic infor­ mation are not fundamentally different from, but rather inseparably linked, to the methods used in gathering regular medical information. therefore, from a legal and public policy perspective, "genetic" discrimination cannot be fund­ amentally different from "normal" discrimination based on regular medical information. if this is true, then like commonly used underwriting criteria, genetic testing procedures have to be considered reasonable sources of data and, as such, are a reasonable basis for legally permissible insurance discrimi­ nation. nevertheless, critics of gene-analysis in health insurance maintain their opposing view by arguing there is a difference between regular medical infor60. see scientific appendix infra part vi. 61. see, e.g., george j. annas, the limits of state laws to protect genetic information, 345 n. eng. j. med. 385, 387 (2001). 16 indiana health law review [vol. 2:1 mation and genetic information, which consists of several factors resulting in a "genetic exceptionalism!t62 one argument is that a person's genotype is beyond that person's control.63 other arguments stipulate that only a ·small number of people would actually be affected by a genetic predisposition. 64 and that genetically ''unlucky" people would be stigmatized.6s the critics maintain the position that genetic information is different in its depth, scope and infl­ uence on the affected individual. it is argued, therefore, that the use of genetic information leads to genetic discrimination. although these arguments seem convincing at first, it is questionable that they can be employed to justify a different legal treatment of genetic tests as · compared to regular medical. 1. only a small number of individuals will be negatively affected by insurers use of genetic information one of the first arguments used to support prohibitive legislation in the field of genetic testing is that the outcome of such tests would only adversely affect a small number of people. greely, a proponent of the argument, who reasons that while genetic predispositions will most likely be concentrated in a small group of" extremely unlucky'' high-risk individuals, it would constitute a cruel policy to allow genetic discrimination in health insurance.66 to support his view, greely offers three arguments: first, health insurance is an important part of life in contemporary america;67 second, providing protection from genetic discrimination would highly benefit those groups of high-risk indivi­ duals;68 and third, "we can afford'' this protection. 69 greely's argument is morally appealing. nevertheless, the mere afford­ ability, which itself is very questionable, does not constitute a duty for private health insurance to support those "unfortunates" . with unfavorable genetic makeup. furthermore, it is not understandable why individuals with a predis­ position for a certain disease should be subsidized through a prohibition of the use of genetic information in health insurance, and individuals who actually have developed a disease should be exempt from that subsidy. why people with a predisposition to develop a disease should be treated more favorably than people who developed such diseases remains unexplained. moreover, if only a small group of people would be affected by negative test results, it 62. geetter, supra note 3, at 56. 63. deborah hellman. what makes genetic discrimination exceptional?, 29 am. j.l. & med. 77,87 (2003). 64. henry t. greely, genotype discrimination: the complex case for some legislative protection, 149u.pa.l.rev.l483,1500(2001). 65. hellman. supra note 63, at 89. 66. greely, supra note 64, at 1500. 67. ld. 68. id. 69. ld. 2005] genetic discrimination in health insurance 17 would constitute discrimination against the unaffected majority to deprive them of the possibility to lower their health insurance premiums through the use of their favorable test results. ~ 2 genetic determinism another argument employed by the critics of the insurer's use of genetic information is that an individual has no control over her genotype. 70 the principle on which this argument is founded is in itself very convincing, namely that a person should be judged on the basis of what he or she does and not on what he or she is. 71 despite the important moral appeal of this argu­ ment, it fails for one reason. as shown above, the importance of genes in the development of certain diseases differs according to whether the disease is monogenic or multifactorial. while the penetrance, the certainty, that a genetic defect will translate into a disease, of a genetic defect in monogenic diseases may in some instances be close to absolute certainty, as in the case of chorea huntington, 72 the penetrance of genetic defects in multifactorial diseases can only reach the concordance-rates ofidentical-twin-studies73 (4060% ). 74 the remaining percentage consists of non-genetic or environmental factors. therefore, a clear predictability of the onset of a multifactorial disease is not possible. consequently, as the idea of a genetic determinism lacks an evidentiary basis; genetic determinism cannot serve as an argument against the use of genetic testing and genetic information. 3. stigmatization the idea of genetic determinism is closely related to another argument employed by the supporters of prohibitive legislation; that genetic predis­ positions to disease are intrinsically stigmatizing. 75 as genetic predispositions to disease stigmatize an affected individual, the use of information concerning that predisposition is stigmatizing, and thus, discriminatory. the underlying claim is that genetic discrimination should be prohibited, either, because of the impact it has on the individual, or, because of the idea it expresses. 76 the effect of genetic testing on the tested individual can be one of psychological 70. gostin, supra note 7, at llo-ll; hellman, supra note 63, at 87. 71. gostin, supra note 7, at 110-11; hellman, supra note 63, at 87. 72. dfg, supra note 5, at 25; richard a. epstein, the legal regulation of genetic discrimination: old responses to new technology, 14 b.u. l. rev. 1, 2 (1994); michael j. smith, population-based genetic studies: informed consent and confidentiality, 18 santa clara computer & high tech. l. j. 57, 64-65 (2001 ). 73. dfg, supra note 5, at 19 (the concordance-rates in identical-twin-studies can reach forty to sixty percent). 74. see scientific appendix infra part vi. 75. hellman, supra note 63, at 89. 76. !d. at 90. 18 indiana health law review (vol. 2:1 trauma. 77 confronted with the elevated chance to develop a possibly life­ threatening disease, individuals might experience an adverse influence of their "death sentence" on major life decisions.78 the risk of suicide, substance abuse, job loss or marriage problems are mentioned as possible effects of pre­ dictive genetic testing. 79 even though holmes argues these risks distinguish predictive genetic tests from diagnostic tests, which reveal the presence of a fatal disease, 80 it is hard to understand why a person with a fatal disease should feel less ·stigmatized than a person with a test that expresses a mere probability of disease development. the "expressivist" theory also argues that the use of genetic information will create a genetic underclass. this theory correlates with the idea of a genetic determinism, 81 which is mostly based on fear rather than on scientifi­ callybased rationality.82 nevertheless, both theories of genetic stigmatization fail to address the core of the problem. it is not the genetic predisposition itself that exerts a stig­ matizing effect. as long as the information about a disposition is not known to a third party, stigmatization is unlikely to occur. therefore, only the dis­ closure of the information to third parties, that an individual has a· genetic predisposition, might cause stigmatization. insurance companies could repre­ sent such third parties. 4. right to privacy it is also argued, that the protection of the right to privacy requires the prohibition of genetic testing and the subsequent use of genetic information in health insurance. as every human's genotype is that person's unique property, a use of genetic information which could culminate in centralized genetic in­ formation databases would violate that person • s civil rights. 83 though describ­ ing a justifiable fear, this argument does not provide a substantial reason for a different treatment of genetic information, because the same argument could be employed to protect regular medical information. from a legal or clinical perspective, there is no warrant to treat medical and genetic information differently. thus, the right to privacy should not be claimed for one type of information as compared to the other. 77. krumm, supra note 7, at 506. 78. holmes, supra note 6, at 573. 79. ronald m. green & a. mathew thomas, dna: five distinguishing features for policy analysis, 11 har.v. j. l. & tech. 571, 572 (1998); krumm, supra note 7, at 506. 80. holmes, supra note 6, at 573. . 81. hellman, supra note 63, at 90. 82. greely, supra note 64, at 1483. 83. holmes, supra note 6, at 569; tara l. rachinsky, genetic testing: toward a comprehensive policy to prevent genetic discrimination in the workplace, 2 u. p a. j. lab. & emp. l. 575, 585 (2000); smith, supra note 72, at 84. 2005] genetic discrimination in health insurance 19 another form of the right to privacy is the "right not to know."84 a person has the right to know about his or her genetic predisposition(s) to certain diseases. 85 this corresponds to the right not to know about those pre­ dispositions. as shown above, the knowledge of a genetic predisposition triggers anxieties and might have adverse effects on life decisions of the affected person. thus it is arguable that as part of the right to privacy, a person should be able to refuse this "burden" of knowledge. still, this does not explain why genetic information should be treated differently from regular medical examinations and the medical information gained thereby. when faced with this concern, critics of genetic testing argue that genetic testing is more invasive than regular medical examinations. 86 moreover, the predictive value of genetic information makes it more vulnerable to abuse than regular medical information. 87 as shown above, genetic testing techniques do not differ fundamentally from regular medical examinations. on the contrary, in many cases they are already part of normal medical examinations. in sum, the information derived from genetic tests constitutes "predictive data," while the information obtained from medical examinations represents diagnostic infor­ mation which has a much higher level of certainty associated with it. never­ theless, the distinction between these two types of information is not meaning­ ful from a legal or public policy perspective. d. discussion in summary, insurers offering health insurance in the individual market and consumers of such health insurance usually have diametrically opposing arguments regarding unfair discrimination in health insurance based on genetic predispositions. insurers argue genetic information, like any other health status related information, should be shared with them in order to prevent the effects of asymmetric information. 88 in order to maintain equity among policyholders, the premiums must reflect the individuals' loss probabilities.89 as a major goal of insurance underwriting is equity, the use of genetic 84. george j. annas, genetic privacy: there ought to be a law, 4 tex. rev. l. & pol. 9, 11 (2000); colby, supra note 10, at 458; patrik s. florencio & erik d. ramanathan, secret code: the need for enhanced privacy protections in the united states and canada to prevent employment discrimination based on genetic and health information, 39 osgoode hall l. j. 77, 88 (2001) (who refer to this as "choice"); holmes, supra note 6, at 574; krumm, supra note 7, at 505; rachinsky, supra note 83, at 583. 85. colby, supra note i 0, at 458; krumm, supra note 7, at 505 rachinsky, supra note 83, at 584. 86. colby, supra note io, at 459. 87. ellen wright clayton, ethical, legal, and social implications of genomic medicine, 349 n. engl. j. med. 562, 563 (2003). 88. colby, supra note i 0, at 461. 89. deborah a. stone, the implications of the human genome project for access to health insurance, in the human genome project and the future of health care 133, 138 (thomas h. murray et al. eds., 1996). 20 indiana health law review [vol. 2:1 information as a basis for a sound actuarial calculation of premium rates would lead to a more accurate reflection of the individuals' risk, thus to a more equitable treatment of applicants and policyholders.90 the opposite, an equal treatment of individuals in premium rates, would result in an unfair "forced" subsidization of high-risk individuals by low-risk individuals.91 this practice would in itself constitute unfair discrimination, which can be avoided by sound actuarially fair risk -classification. 92 on the other hand, supporters of prohibitive legislation argue that the use of genetic information by insurers is subject to abuse resulting in unfair dis­ crimination.93 furthermore, consumers question the reliability and the signifi­ cance of currently available genetic tests for the purpose of insurance under­ writing.94 also, considering the special nature of genetic information, the use of such information could lead to a stigmatization of individuals solely because of their genetic nature.95 as the genetic makeup of an individual is beyond that individual's choice, and the purpose of insurance being risk dis­ tribution among all policyholders, insurance should distribute such involuntary risks among all policyholders.96 therefore, a system of equal access to health insurance through fair risk distribution should be adopted rather than a system of equitable access through risk-classification.97 from our point of view, despite the current lack of simple, inexpensive genetic tests which possibly will be mitigated by technological improvements such as dna-chips or dna-microarrays, the use of genetic testing improves the underwriting process in health insurance by allowing insurers to calculate premiums more accurately. as noted earlier, insurers use probabilistic data in order to calculate fair premium rates; if there was certainty about a health condition, insurance would be pointless. thus, the probabilistic character of genetic information, based on the varying reliability of genetic tests, should not be used as an argument against the inclusion of genetic testing in health insurance underwriting. moreover, as geetter shows, the argumentation in itself is contra­ dictory. 98 the argument that genetic information, based on its predictive value, has the potential to cause stigmatization, is counteracted by the assess­ ment that genetic information is too unreliable to be of much predictive value in the underwriting process. 99 90. colby, supra note 10, at 460; holmes, supra note 6, at 539. 91. holmes, supra note 6, at 544. 92. /d. 93. id at 557; colby, supra note 10, at 454. 94. geetter, supra note 3, at 59. 95. hellman, supra note 63, at 89. 96. colby, supra note i 0, at 457. 97. holmes, supra note 6, at 563. 98. geetter, supra note 3, at 59-60. 99. !d. at 60. 2005] genetic discrimination in healtiiinsurance 21 furthermore, in contrast to the anecdotally00 fueled fears regarding the availability of health insurance coverage, more refined risk-classification would not necessarily lead to less insurability. insurers, when faced with an individual who has an unfavorable genetic makeup, can react with premium increases for full coverage, with coverage exclusions for that particular trait, or by denying coverage at all. 101 overall it is clear that the supporters of prohi­ bitive legislation have a biased view of genetic testing which focuses mainly on individuals with positive, e.g. unfavorable test results. but discrimination is a two-edged sword. the protection of individuals with poor genetic makeup could come at the expense of individuals with favorable genetic traits, resulting in forced insurance premium subsidies. this would be equally unjust, because it would result in actuarially unfair discrimination of the insurance applicants and enrollees with favorable genetic makeup. unfairness occurs when unequal risks are treated equally. in this context, stone argues that, given perfectly predictive medical information, following this definition of fairness would eventually lead to a system in which "each person would pay exactly the cost of his or her own medical care."102 thus insurance would be transformed into an individual medical savings account.103 stone's argumenta­ tion is convincing except for one major point: as shown above, medical information is not perfectly predictive. although the insurance industry relies on risk-pooling, as stone rightfully states, this does not mean, that insurers should not be able to differentiate between groups of different risk-categories. inside these different risk-categories, the risk (that is the risk which remains due to the imperfect medical or genetic predictability) represented by the individuals in the risk-category is sufficient to justify a differentiated treatment in terms of premium calculation in relation to members of the other risk­ categories. 104 as genetic information is not perfectly predictive, there will always remain individually different risks which can be classified into different categories, which prevent insurance to be transformed into individual medical savings accounts. all the above arguments employed by the critics of genetic testing are centered on the idea of a genetic exceptionalism. the idea is that genetic information is new, not only technically, but because it is more revealing than regular medical information. moreover, it is argued the unique predictive 100. greely,supranote64,atl489(statingthattheshortageofwell-documentedexamples of genetic discrimination in health insurance is [indeed] noteworthy); paul steven miller, genetic discrimination in the workplace, 26 j. l. med. & ethics 189,190 (1998) (referring to cases of workplace discrimination). 10 i. the insurance industry classifies the applicant's risk as "standard," "substandard" and "declined." see e.g., mark a. rothstein, predictive genetic testing for alzheimer's disease in long-term care insurance, 35 ga. l. rev. 707 (200i). i 02. stone, supra note 89, at i38; stone, supra note 38, at 293-94. i03. stone, supra note 89, at 138; stone, supra note 38, at 294. i04. anderson, supra note 41, at 15io. 22 indiana health law review [vol. 2:1 value of genetic information offers new possibilities for discrimination, thus requiring a different legal treatment than regular medical information. overall, the arguments fail to establish a significant difference between genetic and regular medical examinations. the arguments fail because, they are based primarily on fear without having a real evidentiary basis.105 scienti­ fically, genetic information is not fundamentally different, more stigmatizing or more invasive than regular medical examinations. 106 furthermore, it does not lead to new questions regarding the right to privacy because it is even less intrusive than regular medical examination results. this becomes evident in the difference of a mere prediction based on genetic testing as compared to a diagnosis based on regular medical examinations. the information about the possibility of developing a disease is less intrusive than the information about having a disease. as genetic information is not proved to be fundamentally different :from regular medical information, the idea of a genetic exception­ alism has to be abandoned. therefore, we must conclude from a legal and public policy perspective that genetic discrimination is not clearly distinguish­ able :from discrimination based on regular medical information. we, therefore, argue that the more convincing case is made by the insurance industry. genetic information, as well as regular medical informa­ tion should be available to health insurers. this should become even more evident, if one considers the important social role of private individual health insurance, which provides coverage for over nine percent of the american public. the only means to protect the socially important individual health insurance market from the effects of adverse selection (for example market failure )107 is to prevent the onset of asymmetric information by granting insurers equal access to genetic information.108 nevertheless, as insurers need this information to prevent the onset of adverse selection and for premium calculation, their use of that information should not exceed these purposes. because the use or disclosure of genetic information other than for risk-classi­ fication is unnecessary for actuarial purposes, any use beyond that limitation should be considered to be an ''unfair 'genetic' discrimination." ll. possffile examples of unfair genetic discrimination in health insurance the next step in our analysis is to describe, where such unfair "genetic discrimination" might actually arise in the health insurance market. in order to do so, we will deal with the group and individual market segments separate­ ly. 105. colin s. diver & jane maslow cohen. genophobia: what is wrong with genetic discrimination?, 149 u. pa. l. rev. 1439, 1448 (2001); geetter, supra note 3, at 57. 106. dfg,supranote 5, at23; diver & cohen, supra note 105 at 1452. 107. see generally akerlof, supra note 43, at 493. 108. holmes, supra note 6, at 545. 2005] genetic discrimination in healrn insurance 23 a. the group market ·genetic discrimination might occur in several stages of health insurance coverage. the first opportunity to use genetic information is provided in the stage prior to enrollment of an individual in a specific plan. health insurance issuers could establish rules governing the eligibility of individuals to enroll in a plan, such as the requirement of the individual or a family member of that individual, to undergo a genetic test or the request that genetic test results be provided. furthermore, health insurance issuers could impose preexisting condition exclusion periods on certain gene-associated diseases. . another possibility would be a raise of the insurance premium of an individual for coverage in a group health plan. at the end of a plan year, the time of policy renewal, insurers could establish rules for policy renewal based on genetic information with respect to an individual or a family member of such individual. furthermore, an increase of premium rates for an individual or the group as a whole could occur. in this context, the disclosure of genetic information by the insurer to an employer or to any other ''unauthorized individual" would constitute an example of unfair discrimination against the individual. b. the individual market in the individual market of health insurance, the above mentioned differentiation between fair and unfair discrimination should be applied. therefore, in the period prior to enrollment, only a complete denial of health insurance coverage would, if based solely on genetic information, constitute unfair discrimination; this is true because the denial of enrollment based on such information is actuarially unnecessary. while the requirement to undergo a genetic test, to disclose genetic information, or to pay a comparably higher premium amount than the average applicant for the same policy would also constitute genetic discrimination, it would not constitute unfair genetic discrimination if all these requirements have an actuarial justification. at the time of policy renewal, insurers could demand that the enrollee undergo genetic testing. based on genetic information derived from such tests, insurers could reassess the premium rate of an individual for continuation of coverage under the policy. furthermore, insurers could discontinue a parti­ cular type of coverage based on the information derived from a genetic test concerning the enrollee or completely deny policy renewal. in theory, the insurer could also terminate the whole policy in the region. similar to the phase prior to policy enrollment, an insurer has to actuarially calculate the proper premium amounts for the enrollment of an individual under a policy at the time of plan renewal. only a denial of policy renewal solely based on genetic information concerning that individual or a family member of that individual would not be justifiable by business standards. in order to offset the impact of asymmetric information, insurers have to know the same information 24 indiana health law review [vol. 2:1 as enrollees. this does not change at the time of policy renewal because both parties, enrollee and insurer, are faced with a new business decision. there­ fore, it can also not be considered unfairly discriminatory, if the insurer decides to terminate the whole policy or to completely pull out of the market in a region. thus, we conclude the only possibility to unfairly discriminate against individuals who either seek individual health insurance coverage or plan­ renewal, is by denying the enrollment in a plan for an actuarially fair premium. as in the group market, the disclosure of genetic information to third parties is not dependent on any actuarial necessity and therefore unfairly discrimina­ tory. ill. how do existing laws affect genetic discrimination in health insurance? it is notable that the laws which relate to genetic discrimination in health insurance so far do not offer a constitutive definition of the term "genetic dis­ crimination." however, in the field of employment discrimination, several laws offer a definition of covered discriminatory behavior. in this article we will concentrate on the provisions offered by the americans with disabilities act of1990 (ada)109 and executive order 13,145 of2000.110 though these two laws primarily deal with employment, their examination might help to pinpoint already prohibited bebavior.in health insurance through an analogous use in employment discrimination. a. provisions under the ada the most discussed law dealing with employment discrimination has been the americans with disabilities act of 1990 which was enacted to secure that individuals with disabilities are able to participate more fully in society. although the ada does not offer a conceptual definition as to what precisely constitutes discrimination, it prohibits discrimination in all the "terms, conditions, and privileges of employment."111 thus, the ada offers a broad based view as to what behavior constitutes employment discrimination against the disabled. in its scope of protection against discrimination, the ada, according to the regulations issued by the equal employment oppor­ tunitycommission (eeoc), encompasses a multitude of employment relation­ ships, including fringe benefits available by virtue of the employment relation­ ship, whether or not administered by the employer. this means that health insurance as a fringe benefit is a protected employment relationship under the 109. 42 u.s.c. §§ 12,101-12,213 (2005). 110. 65 fed. reg. 6877 (feb. 8, 2000). ill. americans with disabilities act of 1990,42 u.s.c. §§ 12,111-12,117 (2005). 2005] genetic discrjmination in heal til insurance 25 statute.112 therefore, discriminatory actions, as defined by the ada, may not be directed against fringe benefits of employees, such as health insurance. the question is how this protection relates to genetic information. the ada itself does not mention "genetic discrimination," but the eeoc included genetic information in its interpretation of the term "disability" under the statute.113 under the ada an individual is considered to be "disabled" if the individual either ( 1) has a physical or mental impairment which substantially limits one or more of that person's major life activities, (2) has a record of such impairment, or (3) is regarded by the employer as having such an impair­ ment.114 the eeoc stated in its compliance manual, section 902.8,115 that "[ c ]overed entities that discriminate against individuals on the basis of [such] genetic information are regarding the individuals as having impairments that substantially limit a major life activity.'' this means that any discrimination on the basis of genetic information concerning an individual simultaneously would constitute discrimination on the basis of a disability under the third category listed above. although this interpretation is highly debatable, 116 there is neither the room nor the necessity to question the eeoc's interpretation of disability in this article, because it offers the only interpretation that includes genetic information as protected under the statute. in the context of this interpretation, the next question is whether the examples of discriminatory action given by the ada are of any value for use in health insurance. under the ada, prohibited discriminatory behavior includes, among others, the following: "limiting, segregating, or classifying a job applicant or employee with a disability in a manner that adversely affects the opportunities or status of the individual.''117 this example directly prohibits the use of genetic information in employment and thus simultaneously prohibits the use of genetic information in the employment-related group market of health insurance. in the case ofhealth insurance offered as a fringe benefit, the limit­ ation of an employee's access to fringe benefits on the basis of genetic infor­ mation would constitute discrimination on the basis of a disability. as men­ tioned above, this interpretation depends on the applicability of the eeoc's 112. geetter, supra note 3, at 37. 113. jared a. feldman & richard j. katz. genetic testing & discrimination in employment: recommending a uniform statutory approach, 19 hofstra lab. & emp. l.j. 389, 404 (2002); rachinsky, supra note 83, at 591; richard h. underwood & ronald g. cadle, genetics, genetic testing, and the specter ofdiscrimination: a discussion using hypothetical cases, 85 ky. l j. 665, 677 (1997). 114. feldman & katz, supra note 113, at 402-03. 115. u.s. equal employment opportunity comm., compliance manual § 902 (2000),availableathttp:llwww.eeoc.govlpolicy/docsl902cm.btml(lastmodifiedfeb.1,2000). 116. steinforth, supra note 7, at 999 (noting that courts are not obliged to follow the eeoc's interpretation); diver & cohen, supra note 105, at 1450; krumm. supra note 7, at 517; rachinsky, supra note 83, at 598; underwood & cadle, supra note 113, at 678. 117. americans withdisabilitiesactof1990, 42 u.s.c. §§ 12112(a)-(b)(1)(2000). 26 indiana health law review [vol. 2:1 interpretation of the term "disability.'' nevertheless it offers an example of a discriminatory practice, which is applicable in the group market of health insurance. in contrast to the, at least questionable, application of the apa on genetic discrimination in health insurance, the federal executive order 13,145 directly deals with genetic discrimination in health insurance. b. provisions under executive order 13,145 executive order 13,145 was signed on february 8, 2000, by former president clinton. 118 it restricts the use of genetic information by federal departments and agencies in federal employment relationships. under section 1-101, it is prohibited to discriminate against an employee with respect to the privileges ofemployment.119 section 1-202(a) and (b) prohibits the segrega­ tion, limitation, or classification of employees that would deprive them of their employment opportunities.12° furthermore, the employing department or agency shall not request, require, purchase, or collect protected genetic infor­ mation with respect to an employee, or information about a request for or receipt of genetic services by such employee. 121 though originally relating to employment, the provision of section 1202(c) in connection with section 1-301(b)(4) and section 1-202(a) and (b) entirely prohibits the use of genetic information in health care services other than related to medical treatment, which excludes health insurance.122 there­ fore, under this executive order, federal departments and agencies are pro­ hibited from using genetic information in any hiring, promotion, or other employment action, such as health insurance as a fringe benefit. still, the pro­ visions only apply to employment by federal departments and agencies, which cover only a small fraction of the insured american population.123 c. discussion limiting the access of an employee to fringe benefits, such as health insurance, could constitute prohibited discrimination in health insurance against a disabled person under section 1211 (a) of the ada. this interpre­ tation depends, however, on the ruling of courts on the eeoc's interpretation of the term "disability." the other provision of the ada is not usable in the health insurance business because it prohibits the use of common and vital risk-classification methods. the effect ofexecutive order 13,145 is limited 118. exec. order no. 13,145,65 fed. reg. 6877 (feb. 8, 2000). ll9. id at 6877. 120. id at 6878. 121. exec. order no. 13,145 § 1-202 (c), 65 fed. reg. 6877,6878 (feb. 8, 2000). 122. exec. order no. 13,145, 65 fed. reg. 6877, 6878-79 (feb. 8, 2000). 123. j. andrew maniko, who shouldknow?: the disclosure debate over genetic information, 26 seton hail legis. j. 151, 178 (200 1 ). 2005] genetic discrimination in healtii insurance 27 to employment in federal departments and agencies. nevertheless, it offers federal employees a broad protection against the use of genetic information ·in the federal employment-related group market of health insurance. even though both laws offer protections against genetic discrimination in the market for employment, they both do not address the market for health insurance directly. therefore, both laws do not reflect the unique market necessities of health insurance, such as fair discrimination among insurance applicants and protections against asymmetric information. as a consequence, the nondiscrimination provisions ofboth laws are not, by analogy, transferable to the market for health insurance. n. provisions of hipaa and gina concerning genetic tests and genetic information in heath insurance the final step in this paper is to analyze the influence of the health insurance portability and accountability act of 1996 (hip aa)124 and genetic information nondiscrimination act of 2003 (gina)125 provisions on genetic discrimination in health insurance. it is notable that both laws are based on the assumption that genetic discrimination represents a new form of discrimina­ tion, based on a new form of information, i.e. genetic information. although it is shown this assumption is not sufficiently backed by scientific reality, we will analyze hip aa and gina in terms of what is specified in the laws and reflected in their definitions of genetic information. however, as we will show, even based on these assumptions, both laws do not offer comprehensive protection against genetic discrimination. the analysis will deal separately with the group and individual markets. a. definition of "genetic information" under hip aa and gina in order to analyze the influence of hip aa and gina on genetic dis­ crimination in health insurance, it is imperative to establish what hip aa and gina include under the term "genetic information." as we have concluded above in part i, genetic information can be derived from several sources, including family histories, phenotype analysis, cytogenetic tests, and dna­ tests. many of these sources are currently used in the diagnosis of diseases in regular medical examinations. furthermore, as we have· shown in part 1,126 genetic information is not distinguishable from regular medical information. however, in this context, it is important to stress to basic assumption under­ lying the development of hip aa and gina. 124. health insurance portability and accountability act of1996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections of18, 19, 16,42 u.s.c.). 125. genetic information nondiscrimination act of2003, s. 1053, 108th cong. (2003). 126. see scientific appendix infra part vi. 28 indiana health law review [vol. 2:1 in contrast to the argument presented in this article, both laws are based on the concept of genetic discrimination as being something "new," which requires special legal attention. this concept is mirrored in the definitions of "genetic information" employed by hip aa and gina. as these definitions are the basis for the statutory provisions, the underlying conceptual assumption is directly expressed in the scope of protection offered by each statute. 1. definition of "genetic information" under hip aa although hip aa itself does not include a definition of genetic infor­ mation, the hip aa regulations offer a definition. the hip aa regulations define "genetic information" as information about genes, gene products, and inherited characteristics that may derive from the. individual or a family member. this includes information regarding carrier status and information derived from laboratory tests that identify mutations in specific genes or chro­ mosomes, physical medical examinations, family histories, and direct analysis of genes or chromosomes. 127 it is interesting to note that in this definition, genetic information includes information derived from physical medical examinations and family histories. as our earlier explanation of genetic test­ ing methods show, a distinctive differentiation between information derived from genetic tests and information derived from regular medical examinations is not justifiable. the difficulty involved with pinpointing what actually con­ stitutes genetic information seems to be reflected in the definition of genetic information offered in the hip aa regulations. these regulations employ a definition which effectively equals genetic information to health status infor­ mation derived from physical medical examinations. because information derived from physical medical examinations is already protected under the "health status" provision of hip aa, genetic information automatically is included under this protection. thus, the inclusion of genetic information under hip aa only has clarifying value. 2. definition of "genetic information" under gina under gina, "genetic information" means information derived from an individual's genetic test, the test of a family member, and the occurrence of a defect or disease in family members of the individual, but excludes informa­ tion about the sex and age of the individual.128 let's quote gina directly: "genetic test" means "an analysis of human dna, rna, chromosomes, 127. see 26 c.f.r. § 54.9801-2t (2005); 29 c.f.r. § 2590.701-1(2005); 45 c.f.r. 144.103 (2005). 128. geneticlnformationnondiscriminationactof2003,s.l053,108thcong. §§ 101(c), 102(a)(3), 103(c) (2003). 2005] genetic discrimination in healrn insurance 29 proteins, and metabolites, that detects genotypes, mutations or chromosomal changes."129 nevertheless, it does not include an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes, or an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medi­ cine involved. 130 this means the definition of "genetic information" under gina does not include health status information that is directly related to an already mani­ fested disease in an individual or information concerning the sex and age of an individual. thus, gina clearly exempts individuals with diseases, whether gene-associated or not, from its nondiscrimination provisions. b. the group market in the group market for health insurance, both hip aa and gina provide protections against genetic discrimination. both laws amend the following statutes relating to health insurance:131 the employee retirement income security act of 1974 (erisa),132 the public health service act (phsa), 133 the internal revenue code of 1986134 and title xviii social security act relating to medigap.135 i. hip aa provisions for the group market the health insurance portability and accountability act of 1996 offers nondiscrimination provisions concerning the. group market, including small employers. 136 we will divide these provisions into provisions for eligibility 129. /d. §§ 101(c), 102 (ax3), 103(c). 130. /d. §§ lol{c), 102(ax3), 103(c). 131. in the next sections we will provide citations to hip aa and gina where the specific amendments of both laws to erisa. phsa, internal revenue code of 1986 and title xvlll social security act can be found. 132. employee retirement income security act of1974, pub. l. no. 93-406,88 stat. 829 (codified as amended in scattered sections of26, 29 u.s.c.). 133. public health service act, ch. 373, 58 stat. 682 (1944) (codified as amended in scattered sections of 42 u.s.c.) 134. 26 u.s.c. §§ 1-9833 (2004). 135. social security act, ch. 531, 49 stat. 620 (42 u.s.c. 301 et seq.), chapter 7, subchapter xviii, part d, § 1395ss. 136. health insurance portability and accountability act ofl996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 19, 16, 42 u.s.c.), title 1, subtitle a. 30 indiana health law review [vol. 2:1 and provisions relating to nondiscrimination in premium contributions, and discuss them accordingly. a. rules for eligibility · the provisions for eligibility are entwined with the rules concerning similarly situated individuals. insurance issuers are still allowed to treat groups of similarly situated individuals differently. however, they are pro­ hibited from treating the similarly situated individuals inside one group of similarly situated individuals differently from one another. 137 the groups of similarly situated individuals may not be established using health status related factors. 138 likewise, any differentiation among the group members may neither be based on health status related factors (including genetic information), nor be directed at a specific individual's health status.139 · the purpose of the statute is a provision of health insurance port­ ability. 140 as such a prohibition of discrimination in (or denial of) enrollment against individuals based on their health status, which includes genetic infor­ mation as defined in the regulations, is part of the statute.141 the question relating to genetic discrimination is whether the rules concerning the eligibility have a significant effect as nondiscrimination legislation with regard to genetic information as defined by hip aa. in relation to genetic information, the pro­ visions of hip aa concerning the eligibility of individuals to enroll in a group health plan can be summarized as follows: 1. the insurance issuers have to apply rules for eligi­ bility uniformly at all the plan members.142 the insurance issuers are neither allowed to establish groups of high risk based on the health status of the individuals, nor can they to impose preexisting condition exclusions on genetic risks, as these are not regarded as preexisting conditions.143 thus, they may not use genetic information as a basis for the eligibility of an individual to enroll in a group health plan. 137. health insurance portability and accountability act of 1996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 19, 16, 42 u.s.c.), title 1, subtitle a, part 1 §§ 101, 1 02; title 4, subtitle a, § 401. 138. /d. 139. /d. 140. see the preamble to the health insurance portability and accountability act of 1996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections ofl8, 19, 16, 42u.s.c.). 141. /d. 142. /d. 143. health insurance portability and accountability act of1996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 19, 16,42 u.s.c.), title 1, subtitle a, part 1, §§ 101, 102; title 4, subtitle a,§ 401. 2005] genetic discrimination in health insurance 2. nevertheless, insurance issuers are still able to restrict the amounts ofbenefits or cancel the coverage for certain medical conditions, if they apply these restrictions uniformly on a group of similarly situated individuals.144 the only exception might be that a restriction was being directed at specific individual participants in the plan; however, this would have to be established. 3. since there is no mandatory minimum benefit or coverage package provided by the statute or the regulations, insurance issuers are free to place a cap on benefits or coverage relating to genetically identifiable diseases, as long as the benefit or coverage or coverage in question is denied to the whole group.t4s 31 although a genetic predisposition to a disease may not be excluded from coverage as a preexisting condition, this provision is open to debate. since insurers are still allowed to exclude the coverage of certain diseases for the whole group, a preexisting condition exclusion for a specific disorder, which would only be in force for twelve months, seems less favorable for the insurers. thus, in the context of this provision, the provision against preexist­ ing condition exclusions based on genetic information seems irrational from a clinical or legal perspective. this is even more apparent if the insurance industry is faced with late-onset diseases, such as alzheimer's, which is unlikely to occur during the first twelve months of coverage. therefore, a pre­ existing condition exclusion concerning genetic information can be meaning­ less, since the insurer could exclude coverage for a specific disorder in a renewal decision, as long as it applies to the whole group.146 considering the above findings, the hip aa provisions relating to the eligibility to enroll pro­ vide no safety against genetic discrimination to insurance applicants, other than the guarantee of enrollment in a health insurance plan with uncertain coverage. b. nondiscrimination in premium amounts the provisions relating to the prohibition of discrimination in setting premium rates stipulate that an individual may not be charged more than the other enrollees in the same group of similarly situated individuals based on any 144. /d. 145. see 26 c.f.r. § 54.9802-1t(bx2xi)(b) (2005); 29 c.f.r § 2590.702(b)(2)(i)(b) (2005); 45 c.f.r § 146.121(bx2)(i)(b) (2005). 146. see 26 c.f .r. § 54.9802-1 t(bx2xi)(b); 29 c.f .r. § 2590.702(bx2xi)(b); 45 c.f.r § 146.12t(bx2)(i)(b). 32 indiana heal til law r.evmw [vol. 2:1 health status related factor of the individual or a dependent of the individual.147 furthermore, the hip aa interim final regulations clarify, that list-billing (billing with separate individual premium rates} practices are prohibited. 148 this serves as a protection of small groups, containing less than twenty-five to fifty employees, against individual insurance underwriting, and as such against the use of genetic information in the underwriting process. . nevertheless, hip aa does not restrict the amount an insurance issuer may' charge an employer for coverage of a group of similarly situated indivi­ duals. 149 consequently, insurance issuers are still able to charge employers higher premium rates based on the claims-experience of the individuals inside the group. therefore, the insurance issuers could still use an estimate of genetic predispositions in a group based on a group's claims experience in order to adjust the price an employer has to pay for coverage of a group. a real protection against higher premium rates based on health factors and especially genetic information is not achieved, because insurance issuers still can reflect a negative claims experience in higher premium amounts, not directed against the "cause," the actual individual requiring expensive treat­ ment, but instead directed against the group as a whole. thus, hip aa only shifts the burden ofhigh medical expenses of individuals to the whole group. taking the above findings into consideration, it is arguable that no comprehensive protection against discrimination based on genetic information is offered by hip aa in the group market of health insurance. the prohibition of underwriting for small groups might be regarded as a protection against discrimination in premium amounts. however as we have explained earlier in part i, small groups with less than twenty-five employees are usually too small to sustain a risk-spreading system and qualify for experience rating. this legal obligation to experience rate in the small group market forces insurance issuers to set premium rates according to the past claims experience of groups, which are too small to sufficiently compensate high medical expenses by the group's premium pool. in order to keep the policies profitable, insurers would either have to raise the group's premium rates, which is still allowed under hip aa, or discontinue offering health insurance coverage for small groups. thus, insurance for small groups would become either very expensive or unavail­ able. although the prohibition of list-billing in the small group market might be regarded as being a provision against discrimination in premium amounts, 147. health insurance portability and accountability act of 1996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 19, 16, 42 u.s.c.), title 1, subtitle a, part 1, §§ 101, 102, title 4, subtitle a,§ 401. 148. 26 c.f.r. § 54.9802-l(c)(2xii) (2005); 29 c.f.r. § 2590.702 (c)(2)(ii) (2005); 45 c.f.r. § 146.121 (c)(2)(ii) (2005). 149. health insurance portability and accountability act of 1996, pub. l. 104-191, 110 stat. 1936 (codified as amended iii scattered sections ofl8,19, 16,42u.s.c.), title i, subtitle a, part 1, §§ 101, 102, title 4, subtitle a, § 401. 2005] genetic discrimination in health insurance 33 it should instead be seen as what it is: a menace to the stability of the small group market of health insurance. 2. gina provisions for the group market 'l' following basically the same conception of genetic information as hip aa, 150 gina enhances the protections given by hip aa. gina prohibits employer-sponsored group health plans and health insurance issuers off¥ring health. insurance in connection with a group health plan by doing the following: (1) imposing enrollment restrictions based on genetic information (which includes the request for or receipt of genetic services by an individual or a family member of such individual). 151 (2) adjusting premiums or contribution amounts for a group on the basis of genetic information of an individual in the group or a family member of such an individual. 152 (3)requesting or requiring an individual to undergo a genetic test.153 in sum, gina specifies that even the request for or receipt of genetic services by an individual, which might hint at a predisposition, is considered to be genetic information and is therefore prohibited from serving as a basis for the application of enrollment restrictions. it is safe to conclude the new provision by gina only clarifies the comprehensiveness of protection of "genetic information," since hip aa already restricts the eligibility of an individual for group health insurance coverage based on genetic information. the third provision concerning the request for, or requirement, of a genetic test as a condition for enrollment, is also little more than a clarifica­ tion. as the request for, or requirement, of a genetic test per definition leads to genetic information,154 the hipaa-provision concerning the restriction of eligibility already applies. although the possibility of a request for, or require­ ment, of a genetic test might be used by health insurance issuers for other purposes (that is other than the determination of the eligibility of an individual 150. see discussion infra parts n.a.l, iv.a.2. 151. genetic information nondiscrimination act of 2003, s. 1053, 108th cong., §§ 101(ax1), 102(axlxa), 103(axl) (2003). 152. /d. §§ 10l(a)(2)(b), 102(a)(l)(b)(ii), 103(a)(2)(b). 153. jd. §§ 101(b), 102(a)(2), 103(b). 154. as defined in gina (see discussion supra, part n.a.2.) and, though slightly different, in the interim final regulations concerning hip aa (see discussion supra, part iv.a.l.). 34 indiana health law review [vol. 2:1 to enroll in a plan), this remaining interest in genetic tests or the results thereof is already covered by the second provision. in this second provision, gina fills a gap left by hip aa concerning the calculation of premium rates for the groups of similarly situated individuals. under the hip aa provisions, the insurance issuers were still allowed to adjust the premium rates for a group as a whole, and to consider all relevant health factors in order to establish aggregate rates for coverage provided under a grol!p health plan. this could lead to unfair discrimination against the healthy group members;155 consequently gina prohibits this kind of discrimination against the group. in other words, the only new anti-discrimination provision introduced by gina in the group market of health insurance is the prohibition of discrimination against a group as a whole based on genetic information concerning an individual in the group. c. the individual market as is true for the group market, both hip aa and gina offer protections against genetic discrimination in the individual health insurance market. i. hip aa provisions for the individual market hip aa amends the provisions of the public health service act concerning the individual market of health insurance156• we will divide the hipaa provisions into: (1) provisions for eligible individuals, and (2) pro­ visions for all individuals seeking health insurance coverage in the individual market ofhealth insurance. a. provisions for eligible individuals the central provision of hip aa concerning the individual health insurance market is a provision for "eligible"157 individuals only. it states that 155. see discussion supra, part iv.b.l. 156. health insurance portability and accountability act of 1996, pub. l. 104-191, 110 stat. 1936 (codified as amended in scattered sections of18, 19, 16,42 u.s.c.), title 1, subtitle b, § 111. 157. eligibility: the individual is eligible if it had at least eighteen months of creditable coverage and its last coverage was under a group health plan, governmental plan or church plan. furthermore, the individual may not be eligible for coverage under a group health plan, medicare or medicaid, and may not have other health insurance coverage (as defined in the health insurance portability and accountability act of 1996, pub. l. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 19, 16,42 u.s.c.), title 1, subtitle b, § 111). creditable coverage: the individual's previous coverage has to be creditable coverage as defined in 45 c.p.r.§ 146.113 (2005). 2005] genetic discrimination in health insurance 35 insurance issuers have to offer eligible individuals coverage and enrollment in insurance policies actively marketed in the individual health insurance market. 158 according to the interpretation in the hip aa regulations, 159 a health insurance issuer meets these requirements, if it provides information about all available options, enrolls the individual in any coverage the individual selects and if it does not impose preexisting condition exclusions on the individual. nevertheless, insurance issuers are still free to set premium rates for individual health insurance coverage for eligible individuals.160 thus, the basic provision for eligible individuals consists of guaranteed health insurance issuance without the possibility ofbeing subjected to a preexisting condition exclusion. in the context of genetic testing and genetic information, this means that eligible individuals have to be offered individual health insurance, and. be enrolled in a plan of their choice, regardless of their genetic makeup. still, the regulations do not restrict the amount an issuer may charge for enrollment under the policy. furthermore, the regulations only implement a restriction on preexisting condition exclusion periods, which do not apply to genetic information, as genetic information does not constitute a preexisting condition under the statute and the regulations. 161 nevertheless, genetic testing as a condition for enrollment is prohibited, because that would be contrary to the main purpose of the regulations; which is to guarantee individual health insurance coverage portability through guaranteed access. insurance issuers still can base the premium rates for insurance coverage of eligible individuals according to their individual risk, and still are allowed to do so by demanding and using genetic information. this could offer health insurance issuers a possibility to protect themselves from adverse selection. the most important groups of creditable coverage are the following: coverage under a group health plan as defined in 45 c.f.r. § 144.103 (2005), health insurance coverage as defined in 45 c.f .r. § 144.103, and medicare and medicaid. this means that creditable coverage not only is group health coverage but also any health insurance coverage, which is, according to 45 c.f .r. § 144.103, benefits consisting of medical care under any hospital or medical service policy or certificate, hospital or medical service plan contract, or hmo contract offered by a health insurance issuer. thus, also individually purchased health insurance coverage, which is health insurance coverage not offered in connection with a group health plan, 45 c.f.r. § 144.103, is creditable coverage under 45 c.f.r. § 146.113. following 45 c.f.r. § 148.103{2) {2005), only the most recent prior creditable coverage of the individual must have been either under a group health plan, governmental plan or church plan (or health insurance coverage offered in connection with any of these). 158. health insurance portability and accountability act of 1996, pub. l. 104-191, 110 stat. 1936 {codified as amended in scattered sections of18, 19, 16, 42 u.s.c. ), title 1, subtitle b, § 111. 159. see 45 c.f.r. § 148.120(a){l) (2005). 160. see 45 c.f.r. § 148.120(g){4). 161. see45 cfr§ 148.120(a)(l) in connection withthehealthlnsuranceportabilityand accountability act ofl996, pub. l. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 19, 16, 42 u.s.c.}, title 1, subtitle a, part 1, § 102(a). 36 indiana health law review [vol. 2:1 because the regulations do not impose restrictions on the pricing of the policies, this could still be done by the states. there is no preemption of state legislation regarding this dimension. however, states are allowed to evade the provisions for eligible indivi­ duals by implementing an alternative mechanism. 162 this alternative mechan­ ism has to provide for a guaranteed offer of health insurance coverage to all eligible individuals, and for a prohibition of preexisting condition exclusion or affiliation periods for coverage of eligible individuals. 163 nevertheless, the implementation of an alternative mechanism by a state actually does not limit the possibilities of the insurance issuers to set premium rates according to individual risk. 164 if a state does not implement such an alternative mechanism, an insurance issuer may elect to limit the coverage required under the regula­ tions165 if it offers eligible individuals at least two policy forms, which must meet certain requirements. 166 as 45 c.f.r. § 148.120(g)(4) clarifies, issuers making this election are still able to adjust premium rates according to the individual risk, and thus based on genetic information, of eligible indivi­ duals.167 nevertheless, the premium adjustments have to be consistent with applicable state law. b. provisions for all individuals according to 45 c.f.r. § 148.122, insurance issuers in the individual market are required to renew the health insurance coverage of all individuals at the option of the individual.168 thus, a health insurance issuer may only discontinue a particular type of coverage, if it provides notice in writing ninety days prior to the termination of the coverage and offers individuals the option to purchase any other individual health insurance currently offered in the state.169 furthermore, the insurance issuers have to act uniformly without regard to health status related factors of the individuals or their covered depen­ dents.170 insurance issuers are still permitted to modify a health insurance coverage policy form at the time of renewal of coverage if it applies the 162. this alternative mechanism is described in 45 c.f.r. § 148.128 (2005). 163. see 45 c.f.r. § 148.128(a)(1). 164. 45 c.f.r. § 148.120(g)(4). 165. 42 c.f.r. § 148.120(a). 166. id § 148.120(c). each policy must be designed for, marketed to and enroll all individuals. the policies must be either the two most popular policy forms as described in § 148.120(c)(2), or representative samples of individual health insurance offered by the issuer in the state, as described in§ 148.120(c)(3). 167. id. § 148.120(g)(4). 168. 45 c.f.r. § 148.122 (2005). 169. 45 c.f.r. § 148.122(d)(1), (2). 170. 45 c.f.r. § 148.122(d)(3). 2005] genetic discrimination in health insurance 37 modification uniformly for all individuals with that policy form. in addition, this modification has to be consistent with applicable state law.171 this means that all individuals are guaranteed renewal of their individual health insurance coverage, and individual level genetic information may not be used in this decision. furthermore a discontinuation of coverage may not be based on the individual's, or a covered dependent of the individual's, genetic information. an insurance issuer can still modify the offered coverage based on genetic information, if it acts uniformly for all individuals with that policy form, and the modification is consistent with state law. as long as a state does not enact laws prohibiting the adjustment of premiums based on genetic information, genetic information and testing may still be used to calculate and adjust premium amounts for non-eligible individuals in that state. furthermore, genetic testing and information derived from such tests may be used by issuers to restrict and condition enrollment of non-eligible individuals. 2. gina provisions for the individual market the possible uses of genetic information allowable under hip aa, as specified above, 172 are significantly reduced by gina. gina stipulates that health insurance issuers offering health insurance coverage in the individual market may not require an individual to undergo a genetic test, may not establish rules for the eligibility or continued eligibility to enroll based on genetic information, and may not adjust premium or contribution amounts based on genetic information. 173 this means eligible individuals, as defined under hip aa, may not be charged different premiums based on their genetic information (or that of a family member), as was still permitted under hipaa.t74 noneligible individuals may not be subjected to enrollment restrictions based on their genetic information (or that of a family member), or be subjected to premium adjustments based on their genetic information (or that of a family member), and neither may be required to undergo a genetic test prior to enrollment.17s therefore noneligible individuals may still be denied enrollment based on other than genetic information (as defined under gina). eligible individuals, as defined under hip .aa, still have guaranteed access to health insurance coverage in the individual market. the pricing of the individuals' coverage, which was still adjustable under hipaa, may not 171. 45 c.f.r § 148.122(g). 172. see supra, part iv .c.i.a. and b. 173. genetic information nondiscrimination act of2003, s. 1053, 1 08th cong., title 1, §§ to2(bxt)(b), t04(ax1xb){t) (2003). 174. see supra, partiv.c.l.a. 175. genetic information nondiscrimination act of2003, s. 1053, 108th cong., title 1, §§ t02(bx1)(b}, t04(axt)(bx1) (2003). 38 indiana heal til law review [vol. 2:1 be adjusted on the basis of genetic information concerning that individual (or a family member of the individual).176 · d. summary of the offered protections in light of unfair genetic discrimination in summary, the results of the analysis of the provisions ofhipaa and gina concerning unfair discrimination in the group market of health insurance are: hip aa guarantees enrollment in group health plans with uncertain coverage; under hip aa, insurance issuers can still reflect a negative claims experience of a group in setting higher premium rates for the whole group; -no real protection against unfair discrimination based on genetic information is offered by hip aa for the group market. except for the prohibition of underwriting for small groups, which, as explained above, does not constitute unfair genetic discrimination as underwriting is necessary in the small group market; gina prohibits the discrimination against a group as a whole based on genetic information concerning an individual in the group. in summary, the results ofthe analysis of the provisions ofhipaa and gina concerning unfair genetic discrimination in the individual market are: hip aa provides that eligible individuals are guaran­ teed health insurance coverage, regardless of genetic informa­ tion concerning them or their family members; under hip aa, all individuals are guaranteed an offer of policy renewal; under hip aa, insurance issuers are still able to calculate their premiums according to genetic information concerning eligible individuals, as long as the states do not enact contrary legislation and policies are ultimately issued; the implementation of an alternative mechanism through a state only restricts issuers in the premium calcula­ tion process, thereby forcing them to subsidize high-risk individuals; 176. genetic information nondiscrimination act of2003, s. 1053, 1 08th cong., title 1, §§ t02(bxt)(b), t04(axi)(bx1) (2003). 2005] genetic discrimination in health insurance the election to limit coverage under 45 c.f.r. § 148.120(c) actually leads to adverse selection problems; hip aa limits the use of genetic information and genetic testing by health insurance issuers to the determina­ tion of premium rates and to the determination of the enroll­ ment of noneligible individuals; -under hip aa, the states are left to legislate insurance issuer's use of genetic information; under gina, noneligible individuals may still be denied enrollment based on factors other than genetic infor­ mation; -the pricing of the individual's coverage, under glna may not be adjusted on the basis of genetic information con­ cerning that individual or a family member of the individual. v. conclusion 39 the current legal and public policy approach for dealing with "genetic discrimination" is fundamentally flawed. as we have shown there is no reason to treat genetic information derived from genetic tests different from infor­ mation derived from regular medical examinations. moreover, we have shown that the two types of information are not readily distinguishable from each other. yet the information derived from regular medical examinations has a different legal status. glna, in combination with hip aa, provides broader protection for genetic information than for information derived from regular medical exa­ minations. this effect matches the greely's proposal, who proposed that the possibility of an individual to sue for genetic discrimination on the ground that a manifested disease provided evidence about a genotype might be prevented.177 because a probative basis for this differentiation does not exist, we have to conclude that hip aa and gina, as they provide for a differentia­ tion between genetic information and regular medical information, are laws merely reacting to fears in the american public, 178 which were fueled by a biased view of the underlying science. taking the above analysis into consideration, we conclude that glna prohibits the use of genetic information in a market where the availability of such information is crucial for health insurers to offset the impact of asym­ metric information. glna fails to acknowledge the necessity of underwriting through fair discrimination in the individual and small group health insurance 177. greely, supra note 64, at 1503. 178. see, e.g., epstein, supra note 72, at 3 (stating that "[t]he dominant attitude ... is strongly hostile to genetic discrimination .... "); diver & cohen, supra note 105, at 1448-49. 40 indiana health law review [vol. 2:1 market. thus, gina endangers the stability of these markets/ 79 especially in the small group market. furthermore, the different treatment of presympto­ matic: and symptomatic conditions is incomprehensible in view of gene­ ass.ociated diseases. yet, the current le~ approach would allow for such differentiation. :in the individual health insurance market, hip aa provides guaranteed enrollment for eligible individuals, regardless of their health status. although under hip aa, the possibilities to calculate actuarially fair premiums according to. genetic information concerning all individuals, as well as to determine the eligibility of noneligible individuals to enroll in a policy according to genetic information concerning these individuals are left to health insurers, both possibilities are prohibited by gina. thus, the insurers' possibility to cal­ culate actuarially fair premium rates is limited to information about the health status of individuals that is not derived from genetic information as defined by gina.. according to the definition of genetic information of gina, this means that insurers are allowed to calculate premiums only based on infor­ mation about already manifested diseases. furthermore, contrary to our fmdings concerning unfair discrimination in the small group market of health insurance, hip aa prohibits list billing practices in this market. thereby, hip aa prohibits the possibility of insurers to use underwriting in a market where risk-spreading alone is insufficient to keep the group profitable, and thus, insurable. because of the guaranteed enrollment provision, small groups do not have to fear that insurers would deny them enrollment. nevertheless, insurers who are confronted with the mandatory enrollment of individuals in unprofitable small group plans will have an incentive to limit the coverage offered in connection with small group health plans in order to keep the plans profitable. this might ultimately lead to a decrease in the level of insurance coverage for small groups, as the extent of coverage is not guaranteed by hip aa. as mentioned above, both hip aa and gina fail to resolve this problem. instead both statutes prohibit the underwriting practices, which are necessary for this market segment. hip aa provides for the states and insurance companies offering health insurance coverage in the individual market the possibility to prevent the application of the requirements and provisions for eligible individuals. however, the .offered methods are undesirable for the health insurers. on the one hand, the implementation of an alternative mechanism by a state forces insurers to either subsidize eligible individuals through a subsidization system between different policies or to subsidize each other in order to cover the expectable higher costs. the possibility for the insurance issuers to limit the required coverage leads to adverse selection problems and is therefore also not desirable for them. 179. see, e.g., diver & cohen, supra note 105, at 1457 (fearing that "adverse selection and favorable deselection could literally tear the individual health insurance market apart''). 2005] genetic discrimination in healtii insurance 41 in the group market, the gap left by hip aa concerning the possibility of health insurance issuers to limit the level of coverage offered for a group health plan remains open. because insurers are not allowed to react to higher claims experiences of a group by raising premium amounts, they might instead restrict the amounts of benefits offered in connection with that group health plan. gina tries to differentiate clearly between information about genotypes and information about (gene-associated) manifested diseases. although the former is protected from insurers use, the latter is not. because of this dif­ ferentiation, gina does not cover the possibility that the genotypes translate into diseases. despite the protection of genotype related information, gina fails to prohibit the use of information about the diseases that result from these genotypes. consequently, gina fails to protect against the possibility of unfair discrimination because of gene-associated diseases. this documents the failure to employ an all-inclusive definition of genetic information. genetic information is inseparably intertwined with information derived from regular medical examinations.180 since many diseases are caused by the interaction of genetic predispositions and environmental factors, this leads to difficulties in distinguishing between discrimination which is based only on genetic predispositions and discrimination that is based on diseases which are at least partly caused by such predispositions. why discrimination based on an individual's genotype should be protected and discrimination based on an individual's (gene-associated) already manifested disease, should not be, is incomprehensible. because the limitation of coverage for group health plans, based on higher claims for gene-associated diseases constitutes unfair genetic discrimination, this type of discrimination should be prohibited. unfortunately neither hip aa nor gina provides the necessary protection. overall, the main flaw of both hip aa and gina is the assumption that genetic information and thus genetic discrimination is different from discri­ mination based on regular medical examinations.· first, the methods used in getting the information are not fundamentally different for genetic and regular medical examinations. second, the quality of information does not differ fundamentally because the only suggested distinguishing feature, the better predictability of gene-associated diseases, is usually unreliable. discrimina­ tion based on the possibility of the development of a disease-as shown-is less intrusive or stigmatizing than discrimination based on already manifest diseases. third, by prohibiting the use of genetic information, hip aa and gina systematically neglect the information requirements of the individual and small group health insurance market and thereby endanger the availability and affordability of these health insurance market segments. gina in combination with hipaa only provides for two protections against genetic discrimination. first, gina fills the gap left open by hip aa 180. see mark a. rothstein. why treating genetic information separately is a bad idea, 4 tex. rev. l. & pol. 33, 34-35 (2000). 42 indiana healdi law review [vol. 2:1 concerning the calculation of premiums of the whole group based on genetic infonnation concerning an individual inside the group. second, in the group marketofhealth insurance, the use of genetic infonnation is effectively banned in enrollment and premium calculation. these two provisions correspond to the view which we adopted earlier in this paper. in the group market of health insurance genetic information serves no actuarial pwpose. therefore, any use of genetic infonnation in this market should be considered to be unfairly discriminatory. unfortunately, these two protections are the only parts of hip aa and gina that are comprehensibly directed against unfair discrimina­ tion in health insurance. many new technological developments encompassing the human genome project, such as gene-chips and microarrays, will offer great possibili­ ties for diagnosis and treatment of diseases. newborn screening, somatic cell therapy, and ultimately the field of phannacogenomics show tremendous progress towards improving health care. as "pharmacogenomics holds the promise that drugs might one day be tailor-made for individuals and adapted to each person's own genetic makeup,"181 genetic information about an individual will be crucial in order to reach this goal. unfortunately, the current legal environment counteracts the achievement of this goal by blocking access to genetic information and by fueling unjust fears of genetic discrimination. in contrast to our findings relating to the impact ofhipaa and gina on "genetic discrimination" in health insurance, we think that public policy should welcome this technological progress and promote the offered benefits to the american public instead of focusing on the creation of a negative view of genetics throughout society. consequently, laws should not be oriented toward blocking society from receiving the benefits these new technological developments offer. vi. scffintific appendix blotting techniques until the invention of the polymerase chain reaction, the analysis of dna sequence polymorphism& relied mostly on ''restriction fragment length polymorphisms" (rflp}182 combined with the southern blot technique. the technique uses local changes of the dna-sequence, so called polymorphisms, which are the product of mutations, such as nucleotide (nucleic acid building 181. human genome project information, medicine: pharmaceuticals, at http://www.ornl.gov/sci/tecbresources/human_ oenome/medicinelpharma.shtml (last visited apr. 16, 2005) (on file with the indiana health law review). 182. "fiiomas d. gelehrtbr & francis s. collins, prjnciplbs of medical genetics 309 (1990); peter]. russeu., genetics 488 (4th ed. 1996). 2005] genetic discrimination in health insurance 43 block) deletions, insertions orpointmutations.183 high-molecular-weightdna is cut with enzymes recognizing a certain nucleotide sequence (restriction enzymes ).184 these enzymes produce dna fragments of differing lengths, depending on the locations of the different restriction sites on the , dna molecule.185 these dna fragments are then transferred onto a membrane filter by blotting and visualized, using radioactive or fluorescent probes.186 rflps will always be visible, if they are located at the restriction sites recognized by the restriction enzymes employed. 187 a disease-associated rflp allows the direct identification of a particular genetic defect 188 a different blotting technique analyzes ribonucleic acid (rna), instead of dna molecules. this technique is called northern blot analysis. in this technique, rna is extracted from a cell and separated by size through gel electrophoresis. 189 then, the rna molecules are transferred and bound to a filter in a procedure which is analogue to southern blotting.190 after the hybridization with a labeled probe, bands indicate the locations of rna species that were complementary to the probe.191 northern blot analysis can be used to determine, for example whether a gene is transcribed (copied into rna), or whether the rna is correctly spliced (fragmented and pieced together) so as to give rise to an rna species (messenger rna) which serves the synthesis of proteins within a cell. both types of blotting procedures are, however, fairly laborious, and will only be used in special cases for disease gene identification. chromosomal aberrations chromosomal aberrations are divided into numerical aberrations, such where the number of chromosomes has changed, and structural aberrations, where the structure of one or more chromosomes is altered.192 chromosomal defects usually lead to characteristic clinical symptoms, such as down­ syndrome, 193 the triple occurrence of chromosome 21 within the genome (the entirety of the genetic infonnation) of an individual.194 183. russell, supra note 182, at 593. 184. id. at 480. 185. id. at 481. 186. ld. 187. id. at 488. 188. id 189. russell, supra note 182, at 481. 190. ld. 191. ld. 192. dfg, supra note 5, at 16. 193. ronald w. dudek, embryology 258 (2d. ed. 1998). 194. id. 44 indiana heal til law review [vol. 2:1 cytogenetic analysis examinations on the chromosomal level (cytogenetic analysis) aim at discovering anomalies in the number, size, and form of the human chromo­ somes.195 this is done through the light-microscopical analysis of so called karyotypes, a complete set of all the metaphase chromosomes in a cell.196 through chromosomal analysis, it is possible to detect chromosomal anom­ alies not only in an individual but also through prenatal diagnosis performed on embryo-derived cells during pregnancy.197 chromosome-analysis helps in diagnosing or verifying diagnoses of different hereditary diseases, such as down-syndrome (trisomy 21 ). monogenic diseases monogenic diseases are caused by defects affecting a single gene. 198 except for mitochondrial mutations,199 monogenic defects are inherited accord­ ing to mendelian rules. 200 diseases due to a monogenic defect are relatively rare, though differences between ethnic groups may occur.201 nevertheless, monogenic diseases can be modulated by other genes or environmental factors.202 this category of diseases may be divided into "autosomal domi­ nant," "autosomal recessive," "x-chromosomal," "y -chromosomal," and "mitochondrially inherited" diseases. 203 examples of monogenic diseases are polydactyly, an autosomal dominant disorder, which is characterized by the presence of extra digits on the hands or feet, and fragile x syndrome, which is an x-linked recessively inherited disease, and characterized by moderate mental retardation. 204 phenotype-analysis the first level of gene-analysis is the examination of an individual's phenotype. 205 because the phenotype is the outcome of genetic and exogenous factors, such as environmental circumstances, it is possible to reach conclu­ sions concerning certain genetic traits of an individual by looking at the 195. russell., supra note 182. at 593. 196. ld. at 328; taeuschet al.,supranote 52, at 104. 197. russell, supra note 182, at 286-87. 198. dfg, supra note 5, at 16; holmes, supra note 6, at 527. 199. andreas ziegler, basic mechanisms of monogenic inheritance, 40 epilepsia 4, 7 (supp. 3 1999). 200. ld. at 6. 201. see, e.g., gostin,supranote 7, at 137; dfg, supra note 5, at 16. 202. dfg, supra note 5, at 24. 203. ziegler, supra note 199, at 6. 204. dudek, supra note 193, at 259-60. 205. gelehrter & coujns, supra note 182, at 307. 2005] genetic discrimination in health insurance 45 physical characteristics, to which the genotype decisively contributes. the analysis itself does not require special techniques other than an examination of an individuals' family history or clinical methods already used in 'regular medical examinations, such as blood-pressure, blood-sugar, mine~ or cholesterol-analysis, as well as ultrasonography and x-ray, which can allserve as highly specific indicators of genetic defects.206 polygenic-multifactorial diseases polygenic or multifactorial diseases, for example neural tube defects or cardiovascular anomalies,207 are caused by an often complex interplay of one or more genetic defects and environmental factors. 208 the importance of genetic factors in the development of multifactorial diseases is usually not fully understood. nevertheless, it is possible to estimate the contribution of genetic defects through studies using identical twins.209 the concordance-rates encountered in such studies are a measure for the relative contribution of genetic factors in the development of diseases.210 usually the concordance­ rates for multifactorial diseases in identical twin studies are between forty and sixty percent.211 this means that the remaining percentage must be due to nongenetic factors. furthermore, even with all genetic factors identified that are associated with a multifactorial disease, the susceptibility to that particular disease will only have a probabilistic quality. it is only possible to predict a relative risk for the carrier of the genetic risk factors. because it is impossible to determine all nongenetic factors, such as environmental influences, the predictability will never be higher than the concordance-rates of identical twin studies. 212 therefore, the idea of a genetic determinism has to be abandoned. polymerase chain reaction (pcr) the pcr-technique, developed by kary b. mullis in 1983, quickly advanced to become the single most important technique in genetic sciences because it allows the amplification213 of small amounts of dna (one molecule is sufficient) for the subsequent analysis, e.g. by sequencing. 214 but the pcr itself can also be used to detect mutations, such as point mutations, insertions, 206. dfg, supra note 5, at 12. 207. dudek, supra note 193, at 260. 208. holmes, supra note 6, at 528; russell, supra note 182, at 755. 209. russell, supra note 182, at 126. 210. dfg, supra note 5, at 19. 211. id. 212. dfg, supra note 5, at 21. 213. gelehrter& collins, supra note 182, at 299. 214. j.christopherpost&garthd.ehrlich,thelmpactofthepolymerasechainreaction in clinical medicine, 283 jama 1544 (2000). 46 indiana health law review [vol. 2:1 or deletions in dna. 215 in pcr, a primer, 216 which may end directly at the location of a suspected mutation, is designed on the basis of a known dna or rna nucleotide sequence.217 first, dna is denaturated during a heating process into two single strands.218 next, the primers are allowed to bind to single strand target dna in a process called .. annealing. "219 then, in a process called elongation, the primers are extended by an enzyme (taq dna poly­ merase), which synthesizes a dna strand complementary to that already present. 220 thus, the dna fragment is copied for the first time. all three steps are then repeated, usually for about thirty cycles. 221 if the primer is homolo­ gous to the unmutated (wild-type} dna sequence,222 an amplification of only the wild-type dna in conjunction with another gene-specific primer on the gene will occur.223 as the wild-type primer will not amplify mutant dna, likewise, the mutant primer will only amplify mutant dna.224 using pcr with both sets of primers in separate reactions, the presence of a mutation sequence is now determinable. 225 protein-chemical analysis the protein-chemical analysis is an examination method, by which one tries to discover gene-associated diseases linked to the presence, absence or alteration of proteins, which can lead to metabolic defects, as encountered in phenylketonuria. 226 furthermore, it is possible to prenatally diagnose neural tube defects by the presence of elevated alpha-fetoprotein levels in the maternal amniotic fluid. 227 though in this type of analysis, it is unnecessary to know the involved gene or chromosome, the use of this technique is restricted by the fact that the proteins which are to be examined, must be available. 228 215. bruce korf, molecular medicine: molecular diagnosis, part 2, 332 new eng. j. med. 1499 (1995). 216. russell, supra note 182, at 360. 217. post & ehrlich, supra note 214, at 1545. 218. id at 1545. 219. id. 220. id. 221. /d. 222. russell, supra note 182, at 69-70. 223. korf, supra note 215, at 1499. 224. id. 225. ld. at 1500. 226. greely, supra note 64, at 1485. 227. dudek, supra note 193, at 260. 228. russell, supra note 182, at 286. 2005] genetic discrimination in heal1h insurance 47 sequencing techniques in dna sequence analysis, cloned dna fragments are analyzed to determine the nucleotide pair sequence of the dna.229 gene sequencing is useful for identifying and controlling gene sequences in the cloned dna fragment. 230 two techniques for the rapid sequencing ofdna molecules were developed in the 1970s, the maxam-gilbert sequencing technique and the sanger sequencing technique.231 the maxam-gilbert method uses chemicals to cleave the dna chain at specific nucleotides.232 by contrast, the sanger method uses a procedure in which the synthesis of new dna strands is stopped by the incorporation of a labeled dideoxynucleotide.233 by using four different dideoxy analogs, synthesis of new dna strands is terminated at differing nucleotide positions, eventually allowing the determination of a complete dna sequence.234 although sequencing techniques are limited in their scope as they are restricted to the analysis of one or very few genes at a time,235 the development ofdna-microarrays or gene-chips might enable the large-scale application of these techniques. 236 in short, these gene-chips allow the simultaneous analysis of thousands of genes in one single analytical step. 237 despite the promising potential of these chip/array technologies, they still face a number of unsolved problems. in particular, the specificity of the results is questionable: given the possibility that non-target nucleic acids with a seventy-five percent sequence similarity may show cross-hybridization,238 the results are more or less based on computerized statistical probability estimation. 239 therefore, the need for conformational studies to assess the relevance of the results still remains an important issue. until these problems are overcome, dna-microarrays should not be considered to be of practical relevance in the analysis of genetic defects and disease predispositions. 229. ld at482. 230. id 231. ld. 232. ld 233. ld 234. russell, supra note 182, at 484. 235. hadley c. king & animesh a sinha, gene expression profile analysis by dna microarrays, 286 jama 2280 (2001). 236. jonathan weems, a proposal for a federal genetic privacy act, 24 j. legal med. 109, 111 (2003); francis s. collins, shattuck lecturemedical and societal consequences of the human genome project, 341 new eng. j. med. 33 (1999). 237. king & sinha, supra note 235, at 2280. 238. ld. at 2286. 239. dfg, supra note 5, at 20. william snyder hall: in memorium by eleanor d. kinney, jd, mph had render professor of law indiana university school of lawindianapolis the academic program in health law at indiana university school of lawindianapolis has lost one of its best friends, bill hall. william snyder hall, age 93, of indianapolis, passed away sunday, october 24,2004. the center for law and health was named in honor of bill hall and his wonderful wife christine s. hall just last fall, 2004. how this came to pass is indicative of the kind of man bill hall was as well as the kind of friend bill hall was to his alma mater. more later on this story. bill hall was born december 15, 1910 in brazil, indiana, the son of the late 1.0. hall and helen louise (snyder) hall. mr. hall attended public school in brazil, indiana until moving to indianapolis in the 1920s. he graduated from park school in 1929 and then attended the university of pennsylvania, wharton school, graduating in 1933 with a b.s. degree in economics and finance. bill hall started in business at an auspicious time -the 1930s. he was in the oil and gas business in texas until 1941 -just after the supreme court's famous decision on delegation oflegislative power, panama refining co. v. ryan, 293 u.s. 388 (1935), that concerned the texas oil industry. from 1941 to 1944, bill hall was in the chromium business in oregon. in mid-career, like so many of our students, bill hall decided to attend law school. he came back home to indiana and went to night school at indiana university law school. he graduated with a j.d. degree in june 1951. following his graduation, he practiced law in indianapolis with the law firm of dowden, denny, caughran & lowe until the mid-1960s. bill hall was the first health lawyer in the state of indiana and, indeed, one of the first in the nation. health law was an unknown field before the 1960s. the inauguration of the medicare and medicaid programs in 1965 changed all that. with these programs, the number and complexity of health care institutions grew in leaps and bounds given the infusion of very generous payment for services and the pent up demand for health care among the elderly and disable. bill hall was present at the creation, saw the opportunity and ran with it in the tradition of the best of creative lawyers. bill hall's accomplishments in health law are legion. in 1967, he foimded the law frrm ofhall, render, killian, heath & lyman. hall render, which has focused its practice primarily in the area of health law and is one ofthe nation's preeminent health law firms. bill served as general counsel to the indiana hospital & health association (formerly indiana hospital association) since 1960. he taught public health law at the indiana university school ofmedicine and served on state commissions for health law reform. bill hall was also involved with some of the most important medicare litigation of his day working creatively to establish the system for federal payment for hospital services for medicare beneficiaries in ways that assured high quality care for medicare beneficiaries and the continued growth of hospitals and their teaching and research missions. not surprisingly, bill hall was recognized and honored by many on many occasions. his preparatory school, park tudor (formerly the park school), honored him as outstanding alumnus just this year. mr. hall was the recipient of the distinguished sagamore of the wabash award on two occasions, october 3, 1979 from republican gov. otis r. bowen and december 2000 from democrat gov. frank o'bannon. he was also awarded the distinguished hoosier award in 1994 from gov. evan bay h. as a member of the indiana state bar association for 50 years, he received its attorney golden career award on october 4, 2002. on november 10, 2003, he and his wonderful wife, christine, received yet another honor. in their honor, the shareholders ofhall render contributed the funds to remodel space in the law school for a fabulous, state-of-the-art space for the center for law and health and the indiana health law review. the story about how this came all came about bears witness to the kind of man bill hall was and why we are so incredibly proud to have his name and that of chris hall's affixed to the center for law and health. bill hall was acutely aware that everyone needs the help of others to reach their goals. he always appreciated the help that his law school had provided him in becoming a lawyer. he was a generous contributor to the law school financially and funded the hall render professorship which is my honor to hold. he was incredibly generous to students and associates with his time, advice and willingness to share his experiences with a health law class. i recall a time that i was writing a report for yet another indiana health reform commission and wanted a section on the contributions of public hospitals. i sent a student over to see bill hall to get background information. three hours later, the student returned wide-eyed from his afternoon with bill hall. bill had traced the story of public hospitals in indiana, his involvement in rewriting the statutes regulating public hospitals and locating public hospitals in the overall mission of the health care sector. bill hall was generous to everyone who came his way. for example, he worked for an organization that placed high school drop outs in summer internships with health care institutions with the view to getting them back on track. he.had a special relationship with a former coordinator of the center who worked with him to take on interns at the center to gain job skills and confidence under her protective wing. i loved being bill hall's ''professor." in academia, it is generally thought better to hold a chair contributed by one who has passed on rather than one who is still here. i have colleagues in the later group who are constantly critiqued by their benefactors to the point of distraction. bill was my critic in the best sense of the word he would call and write from time to time. he would ask about various matters, give advice and just make sure i was on the right path. he would habitually refer to me as "my professor." i loved it. i appreciated the guidance and the fact that he cared in our enterprise. now i miss his "interference" terribly. he cared about our work at the center. when he heard about the need for funds to remodel the space for the center for law and health, he promised to guarantee the funds that we would raise from others so that we could be~n construction immediately. it was then that his partners stepped in with their well-deserved surprise. it is an honor for the law school to have the opportunity to name the center for law and health, the william s. and christine s. hall center for law and health. chris is a wonderful person with her own fine story. bill's story is wonderful too. he conducted his career and lived his life with the knowledge of who put him here on earth and why. we do and will miss him. ruth r. faden ruth r. faden, m.p.h., ph.d., is the philip franklin wagley professor of biomedical ethics and executive director of the phoebe r. berman bioethics institute at johns hopkins university. she is also a professor in the depart­ ment of health policy & management in the johns hopkins school of public health and a professor of the department of medicine in the johns hopkins school of medicine. additionally, she is a senior research scholar at the kennedy institute of ethics, georgetown university. dr. faden is the author and editor of numerous books and articles on biomedical ethics and health policy, including a history and theory of informed consent (with tom l. beauchamp, 1986), aids, women, and the next generation (ruth faden, gail geller & madison powers eds., 1991), idv, aids and childbearing: pubucpoucy,priv ate lives (ruth faden & nancy kass eds., 1996). dr. faden is a member of the institute of medicine and a fellow of the hastings center and the american psychological association. she has served on several national advisory committees and commissions, including the president's advisory committee on human radiation experiments, which she chaired. dr. faden holds a b.a. from the university of pennsylvania, a m.a. in general studies in humanities from the university of chicago, and a m.p.h. and ph.d. (program in attitudes and behavior) from the university of california, berkeley. legal and ethical considerations in government compensation plans: a case study ofs~x~tion naomi seiler* holly taylor** ruth faden*** introduction how did we get here? how did we get to this deeply flawed policy creating so much frustration for families struggling in the present and with no plan for the future? we got here, we would argue, because we never paused for a key philosophical debate. it takes more than three days to face the kind of questions that arise from a different sort of war. what is our government's responsibility for its citizens-and what are the limits of that responsibility? is it the government's role to compensate victims in the first place? and if so, exactly how?1 new york times reporter lisa belkin wrote these words in december of 2002, at the conclusion of an article exploring the september 11th victim compensation fund2 ("911 fund") and the reactions of family members to the course that the program took. with over a year's perspective on the events, belkin saw that the hastily-constructed compensation program. administered with the best of intentions, was lacking coherence of design and aim. five days after belkin's article appeared, president bush announced his administration's proposal for a smallpox immunization plan.3 fears that stockpiles of the virus could fall into the hands of terrorists or enemy nations had driven the development of a program to vaccinate ''frontline" healthcare workers and, later, portions of the public. despite the risk of severe side effects, the plan contained no clear articulation of a compensation policy in * greenwalt fellow in bioethics and health policy, bloomberg school of public health, johns hopkins university. ** assistant research professor, department of health policy and management, bloomberg school of public health and core faculty, phoebe r. berman bioethics institute, johns hopkins university. *** philip franklin wagley professor of biomedical ethics and executive director phoebe r. berman bioethics institute, johns hopkins university. 1. lisa belkin, just money, n.y. times, dec. 8, 2002, (magazine), at 92. 2. air transportation safety and system stabilization act, pub. l. no. 107-42, § 403, 115 stat. 237,237 (2001). 3. see president george w. bush, remarks by the president on smallpox vaccination (dec. 13, 2002), available at http://www.whitebouse.gov/newslreleases/2002/121200212137.html. 4 indiana health law review [vol. 1:1 the event of injury or death.4 the only mention of the issue appeared in an annex. which stated that one federal responsibility that "may be added" was "assessing the need for and scope of a suitable liability program for vaccine manufacturers and persons administering the vaccine."5 fearing that a lack of deliberation would cause problems like those seen with the 911 fund, we began writing this article with the intention of out­ lining recommendations for a policy to compensate people injured or killed in a smallpox immunization scheme. we sought to identify the legal, ethical, and practical questions that must be addressed in order to answer the funda­ mental question: what, if anything, does our government owe to people injured by a bioterrorism attack or by attempts to prepare for such an attack? since we began our research, the situation has changed. on october 15, 2003, the director of smallpox preparedness and response at the centers for disease control and prevention ("cdc") announced that the program had effectively ended: "the fact is, it's ceased, ... not that anyone's issued an edict to say stop."6 far fewer healthcare workers than expected had been immunized; the already-slow pace dropped sharply after several vaccinees died of heart problems.7 although states had initially planned to immunize 450,000 workers, the total count of vaccinees is less than 40,000.8 this article, therefore, is not a proposal. but rather, it presents a case study of how a compensation program for the smallpox immunization scheme should have been contemplated and provides a framework for contemplating similar programs. it is difficult to draw lessons from the recent immunization campaign because of its limited scope. however, the collapse of the program does underscore the importance of compensation: one explanation given for the low participation rates by healthcare workers was the lack of a compensa­ tion plan.9 our goal is not to outline a detailed plan, but to analyze the questions that should have been asked early in the program's development. this analy­ sis, and our illustration of how the analysis could have been applied to small­ pox, yields lessons for any government compensation scheme and holds profound implications for public health and the principles it reflects. what is the government's responsibility when its citizens are harmed by outside forces or by our own efforts at protection? if we implement a system that sacrifices 4.id. 5. ctrs. for disease control & prevention, annex 5: suggested pre-event activities for state and weal public health authorities (may 21, 2003), a4-3. 6. anita manning, smallpox vaccination plan 'ceased'; program is cog of bioterror response, usa today, oct. 16, 2003, at aol. 7. ld. the heart problems have not been definitively linked to the vaccinations. see infra notes 92-93 and accompanying text. 8. ld. 9. alicia ault, us smallpox vaccine programme stalls as volunteers balk, 361 lancet 1626, 1626 (2003). 2004] case study of smallpox immunization 5 the health or lives of an unpredictable few for the good of many, how should we allocate the costs that fall on those few? part i offers background on smallpox: its causes, effects, and the history of efforts to prevent and then eradicate it part ii continues with an overview of the bush administration's development of a smallpox immunization plan and traces the course that the program has taken. in part m, we analyze the ethical, legal, and practical questions that arise in the creation of a compensa­ tion program. we incorporate examples of past government compensation schemes-most related to public health-to consider how these questions can and should be answered. in part n, we illustrate how these questions could have been addressed in the current smallpox immunization policy. we con­ clude with recommendations for future public health-related government com­ pensation policies. while the smallpox case is most directly translatable to other disease-related harms, the issues it raises are relevant to any government compensation program. i. the disease prior to its eradication in nature in 1980,10 smallpox was responsible for millions of deaths annually worldwide. 11 smallpox is transmitted by exposure to respiratory droplets from someone with the virus or to infected clothing and bedding. 12 once infected, individuals experience a latent phase of four to fourteen days, during which they are not infectious but the virus is rapidly multiplying in their bodies.13 this latent period is followed by a phase charac­ terized by headache, backache, and fever.14 during this time, the virus begins to infect the mucus membranes in the mouth and pharynx, and infected individuals become able to transmit the virus to others. 15 finally, the virus in­ fects the skin, and pox appear over the entire body .16 the individual remains infectious for seven to ten days after the pox appear on the skin. 17 there is no effective treatment for smallpox. 18 if given within four days of infection, the smallpox vaccination is likely to mitigate the severity of the disease.19 in addition, if a case of smallpox appeared today, physicians might prescribe a strong antiviral medication, cidofovir, currently approved for cyto10. joel g. breman & d.a henderson, diagnosis and management of smallpox, 346 new eng. j. med. 1300, 1300 (2002). 11. world health org., smallpox eradication-a global first (1998), at http://www.who.int/archiveslwho50/en/smallpox.htm (last visited feb. 6, 2004). 12. breman & henderson, supra note 10, at 1302. 13. ld. at 1300. 14./d. 15. id. at 1300-01. 16. id. at 1301. 17. id. at 1302. donalda. hendersonetal.,smallpoxasabiologicalweapon: medical and public health management, 281 jama 2127, 2129 (1999). 18. breman & henderson, supra note 10, at 1302. 19. id. at 1304. 6 indiana health law review [vol. 1:1 megalovirus but not smallpox. however, cidofovir has serious side effects, and there is no evidence that giving cidofovir is any more effective than post­ exposure vaccination. 20 untreated smallpox has a case fatality rate of 30%.21 variola minor, a milder form of smallpox, has a case fatality rate of 1%.22 smallpox vaccination was routine in the united states until 1972. routine smallpox vaccination was halted in the united states when declining prevalence of the disease made the risks of vaccination outweigh the likeli­ hood of exposure to the virus. 23 the smallpox vaccine used in the 1960s, which remains in use today, is prepared from live vaccinia virus rather than live smallpox virus; therefore, there is no risk of infection with smallpox as a result of vaccination. 24 dryvax vaccine (manufactured by wyeth laborato­ ries) is the only smallpox vaccine currently licensed for use in the united states.25 acambis/baxter is currently under contract with the cdc to produce additional vaccine. that stock is expected to be licensed in 2004 if shown to be equivalent to dryvax in clinical testing. 26 the most comprehensive adverse event profile for smallpox vaccination is based on data collected during routine smallpox vaccination in the 1960s. 27 based on the experience of over thirteen million vaccinations, the risk of death as a result of vaccination is one in one million. 28 of those experiencing com­ plications post-vaccination (seventy-four per one million), 68% were primary vaccinees, 7% re-vaccinees, and 20% bad contact with a vaccinee.29 life­ threatening complications included eczema vaccinatum, progressive vaccinia, and postvaccinial encephalitis. vaccinia immune globulin ("vig") is recom­ mended for the treatment of most adverse events, 30 but there is currently no treatment available for postvaccinial encephalitis.31 other antibacterial and 20. ld. at 1302-04; henderson et al., supra note 17, at 2132. 21. henderson et al., supra note 17, at 2127. 22. ld. at 2129. 23. michael r. albert et al.,tir4 last smallpox epidemic in boston and the vaccination controversy, 1901-1903, 344neweng.j.med. 375,378 (2001). 24. vincent a. fulginiti et al., smallpox vaccination: a review, part l background, vaccination technique, normal vaccination and revaccination. and expected normal reactions, 37 cunicallnfectious diseases 241,243 (2003). 25. /d.; ci'rs. for disease control & prevention, vaccinia (smallpox) vaccine: recommendations of the advisory committee on immunization practices (acip), 50(rr-10) morbidity & mortality wkly. rep. 1, 3 (2001) [hereinafter cdc, recommendations of acip]. 26. fulginiti et al., supra note 24, at 243-44. 27. see 1. michael lane et al., complications of smallpox vaccination, 1968: national surveillance in the united states, 281 new eno.j. med. 1201 (1969). 28. id. at 1206. 29. ld. at 1203. 30. ctrs. for disease control & prevention, smallpox vaccination and adverse reactions: guidt.mcefor clinicians, 52(rr04) morbidity &mortalitywkly. rep. 1, 23 (2003) [hereinafter cdc, guidance]. 31. vincent a. fulginiti et al., smallpox vaccination: a review, part il adverse events, 37 cunicallnfectious diseases 251, 268 (2003). 2004] casestudyofs~x~m~tion 7 antiviral therapy may be recommended depending on the type of adverse event or if there is no response to vig. 32 in addition to the direct risks of vaccination, those who are indirectly exposed to vaccinia virus are also at risk for adverse events. 33 although trans­ mission of vaccinia virus is rare, those who come in direct contact with someone who has been vaccinated and is actively shedding vaccinia virus (from a vaccine site that is not fully healed) are at risk for infection with the vaccinia virus (inadvertent inoculation) and for eczema vaccinatum.34 there is little or no evidence that otherwise healthy individuals will experience severe side effects as a result of their exposure to vaccinia virus. 35 vig treat­ ment is not recommended for those infected with vaccinia virus and who are otherwise healthy. 36 in comparison with the smallpox virus itself, airborne transmission of vaccinia virus is unlikely, but possible.37 cases of airborne transmission have been attributed to cases of vaccinia-related tonsillitis after vaccination with a more reatogenic vaccine than that used in the united states, and after expo­ sure to a hospitalized case of eczema vaccinatum. 38 noting that the latter cases of infection could have occurred as a result of "fomites or the hands of [health care workers]," lane and fulginiti conclude that airborne transmission of vaccinia from normal vaccinations is doubtful. 39 the last naturally-occurring case of smallpox in the united states was reported in 1949, and the mass vaccination progralns in the united states were halted in 1972.40 as a result, few americans under thirty years of age have been vaccinated.41 those adults who were vaccinated as children have likely lost any protection from infection with smallpox, but are expected to experience a milder form of the disease if infected.42 recent evidence indicates that those vaccinated in the past may produce an antibody response to the smallpox virus for up to seventy-five years after vaccination, but it is unclear whether the ability to mount an antibody response constitutes full protection against infection. 43 32. cdc guidance, supra note 30, at 24. 33. j. michael lane & vincent a. fulginiti, transmission of vaccinia virus and rationale for measures for prevention, 37 cunical infectious diseases 281 (2003); john m. neff et al., contact vacciniatransmission of vaccinia from. smallpox vaccination, 288 jama1901(2002);kenta.sepkowitz,howcontagiousisvaccinia?,348neweno.j.med. 439 (2003). 34. neff et al., supra note 33, at 1903-04. 35. id. at 1903. 36. cdc, guidance, supra note 30, at 22. 37. lane & fulginiti, supra note 33, at 283; sepkowitz, supra note 33, at 445. 38. lane & fulginiti, supra note 33, at 282. 39. /d. at 283. 40. neff et al., supra note 33, at 1903. 41. /d. 42. henderson et al., supra note 17, at 2132; fulginiti et al., supra note 24, at 243. 43. erikahammarlundetal.,duration of antiviral immunity after smallpox vaccination, 9naturemed.l131 (2003). 8 indiana health law review [vol 1:1 after the eradication of naturally-occurring smallpox virus, there was an effort to destroy all remaining stocks or to ship them to one of two secure research labs.44 by the late 1980s, the only known stocks that remained were held at the cdc in atlanta. georgia and the research institute of viral preparations in moscow, russia, which later moved its specimens to the state research center for virology and biotechnology ("srcvb") in novosibirsk, russia.45 in the 1990s, the world health organization (''who") coordinated discussions about whether to destroy the remaining stocks of smallpox virus.46 after deliberations in 1999, the who committee on variola virus research reaffirmed a previous decision to destroy the remaining stocks, but deferred destruction to allow further research on the virus, adding that research on the virus "should, under no circumstances, continue beyond the end of 2002."47 ll. recent u.s. smallpox vaccination plans the terrorist attacks of 2001 and the anthrax deaths that occurred soon after changed the course of smallpox policy.48 questions about the security of russian labs after the fall of the soviet union, combined with concerns that all countries may not have destroyed their smallpox virus stocks, led to the fear that smallpox virus may have fallen into the hands of rogue nations or terrorist organizations.49 in may 2002, the world health assembly ("wha") announced that research on the smallpox virus would continue. 5° a report of deliberations by the who committee in november 2002 notes progress in the development of new diagnostics, drugs, and vaccines for smallpox. 51 with a heightened sense of its own vulnerabilities, the united states launched a program to prepare for a potential smallpox attack. in early 2002, the public health and national defense communities within the bush administration actively debated whether to vaccinate a core group ofhealthcare workers and other critical personnel-a control and containment 44. henderson et al, supra note 17, at 2128. 45. breman & henderson. supra note 10, at 1300. 46. woridhealth0rg., whoadvisorycommitteeon variola virus research: report of a who meeting, who/cds/csr/2000.1, (dec. 6-9, 1999), available at http://www.who .int/emc-documents/viral_diseases/docslwhocdscsr20001.pdf. 47. id. at 11. 48. authony fauci, smallpox vaccination policytheneedfor dialogue, 346 new eng. j. med. 1319 (2002); fulginiti et al., supra note 24, at 241. 49. william j. bicknell, the case for voluntary smallpox vaccination, 346 new eng. j. med. 1323, 1323 (2002); fauci, supra _note 48, at 1319. 50. fifry-f'ifth world health assembly, smallpox eradication: destruction of variola virus stocks, wha55.l5, (may 18, 2002), available at http://www.co.thurston. wa.us/ health/phep/documents/wh0%202002%20decision%20on%20destruction%20of%20small pox%20stock.pdf. 51. woridhealthorg., who advisory committee on variola virus research: report of the fourth meeting, who/cds/csr/2000.1, (nov. 20-21, 2002), available at http://www. who.int/csr/resources/publicationslviral/whocdscsrgar20035.pdf. 2004] case study of smallpox lmmunization 9 strategy-or to initiate a program to vaccinate the general population.52 in june 2002, the advisory committee on immunization practices ("acip"), a standing advisory group to the cdc, recommended that 20,000 health care and other critical personnel be vaccinated for smallpox in order to respond in case of a smallpox attack.53 their recommendation of only a focused immunization campaign was based on the assumption that the risk of serious adverse events in a general-population campaign outweighed the risk of a smallpox outbreak. these recommendations updated their previous recom­ mendations presented in june 2001.54 the 2001 acip recommendations focused on the vaccination of lab workers to protect them from exposure to orthopoxviruses, but introduced a number of issues and considerations in anticipation of the intentional release of smallpox as a bioweapon. 55 after a spate of rumors that the bush adminis­ tration had plans to recommend vaccination for many frontline workers, acip revised their recommendations to suggest the vaccination of up to 500,000 health care workers and other critical personnel in october 2002.56 on december 13, 2002, president bush announced the administration's smallpox vaccination plan. 57 the plan included the immediate and mandatory vaccination of up to 500,000 military personnel; voluntary vaccination of up to 500,000 health care workers and other critical personnel to start forming smallpox response teams on january 24, 2003 (the effective date of the homeland security act); to be followed by vaccination of up to ten million first responders. in addition, the president announced that the administration would make unlicensed 58 vaccines available to otherwise healthy members of the general population who insist on access. 59 52. jon cohen & martin enserink:, rough-and-tumble behind bush's smallpox policy, 298 science 2312, 2312 (2002). 53. ctrs. for disease coni'rol& prevention, record of the meeting of the advisory committee on immunization practices, (june 19-20, 2002), available at http://www.cdc.gov/nip/acip/minutes/acip-min-jun02.pdf; ceci connolly, smallpox vaccine program readied: inoculations may surpass 500,000 under u.s. plan, wash. post, july 8, 2002, at ao 1. 54. cdc, recommendations of acip, supra note 25, at 3. 55.id. 56. lawrence k. altman, threats and responses: biological readiness; smallpox inoculation urged for employees of hospitals, n.y. times, oct. 17, 2002, at a20; david brown, limited smallpox vaccine use eyed; expert panel rejects mass inoculations, wash. post, june 21, 2002, at aol; cohen & enserink, supra note 52, at 2312; voluntary smallpox vaccination urged: offer to general population represents a shift in policy, wash. post, oct. 5, 2002, at aol 57. bush, supra note 3. 58. the vaccine will be unlicensed unti12004. fulginiti et al., supra note 24, at 243. 59. bush, supra note 3. 10 indiana healrn law review [vol. 1:1 a. lack of a compensation plan on the day the national smallpox vaccination campaign was announced, there was no federal program in place to compensate those individuals vacci­ nated or exposed to vaccinia for injury, or to compensate their families in the case of death. the homeland security act, signed in november 2002, re­ moved liability for injury from vaccine manufacturers and individuals and institutions who would be administering vaccinations. 60 any injured vacci­ nees would have to sue the federal government under the federal tort claims act and prove negligence to receive compensation. 61 with the initial vaccinations set to commence on january 24, 2003, healthcare union and professional associations began to voice concern about the lack of provisions for injury compensation. 62 a number of hospitals refused to begin the vaccination of their employees until the issue of compen­ sation was resolved. 63 concerns were multiple: workers' compensation pro­ grams might not cover injuries sustained by an employee who volunteers to be vaccinated, medical expenses related to injuries sustained might not be covered by health insurance, income and staff might be lost for days if employees needed to recover from adverse events, and patients might sustain injuries from indirect exposure to vaccinia. 64 despite these concerns, the washington post reported that as of january 2003, the bush administration would not be creating a compensation fund to cover these costs. 65 the institute of medicine ("10m''), asked by the cdc to consult on implementa­ tion of the smallpox vaccination program, cautioned that the "currently stated plans for compensation for adverse reactions could seriously affect achieve­ ment of the stated goal of the program-to increase the nation's bioterrorism preparedness. "66 further complicating the picture was the fact that previous smallpox vaccination programs focused on children, who generally received the vaccine 60. homeland security actof2002,pub.l.no.107-296, §304,116stat.2135, 2165-67 (2002). 61. joan stephenson, smallpox vaccine program launched amid concerns raised by expert panel, unions, 289 jama 685, 685 (2003). 62. aaem/saemsmau.poxvaccinationworkinogroup, smallpox vaccination for emergency physicians, 10 acad. emergency med. 681, 682 (2003); letter from american federation of state, county and municipal employees to president bush (jan. 16, 2003), available at http://www.afscme.org/actionll030116.htm; letter from barbara a blakeney, american nurses association, to president bush (jan. 16, 2003), available at http://www.nursingworld.orglpressrel/2003jltr0116.htm;raymoynihan,healthprofessionals challenge us smallpox vaccination plan, 326 brit. med. j. 179 (2003). 63. julie piotrowski, smallpox, big worries, 33 modern healthcare 6, 7 (2003). 64. lnst. of med., review of the centers for disease control and prevention's smallpox vaccination program implementation, letter rep. 1 (jan. 16, 2003). 65. ceci connolly, caregivers protectedagainstsmaupoxlawsuits; bush plan would not compensate patients for vaccine's side effects or accidental exposure to virus, wash. post, jan. 15, 2003, at a14. 66. lnst. ofmed., supra note 64, at 8. 2004] case study of smallpox immunization 11 after their first birthday.67 by contrast, the current smallpox vaccination pro­ gram targeted adults who, both because of the age-related burden of disease and subsequent changes in public health and advances in medicine, are more likely than participants in earlier vaccination campaigns to be immuno­ compromised, either because of ihv i aids or treatment for transplant rejec­ tion or cancer. 68 immunocompromised individuals are more likely to exper­ ience severe adverse events due to smallpox vaccination than individuals with healthy immune systems. 69 those who have eczema are also more likely to experience more severe adverse events from smallpox vaccination. 70 in the absence of an actual release of smallpox, pregnant women should not be vaccinated, given the risks of fetal infection. 71 in addition, anyone who has close contact with a person for whom vaccination is contraindicated should also avoid pre-release vaccination, as they could transmit the vaccinia virus. 72 because of these and other concerns, efforts are underway to produce safer vaccine products. 73 congressman henry waxman and a number of his congressional colle­ agues sent a letter to the white house on january 17, 2003 in response to the aforementioned report in the washington post. in that letter, congressman waxman and his colleagues called on the bush administration to create a "no­ fault" compensation plan to compensate anyone harmed as a result of small­ pox vaccination or exposure to vaccinia. 74 on february 13, 2003, congress­ man waxman introduced hr. 865, the smallpox vaccine compensation and safety act of2003, which authorized no-fault compensation forinjury, grants to states to cover the implementation of the vaccine program, protection from discrimination for individuals who refuse vaccination, and coverage of costs of up to four days of leave for health care workers who experience short-term adverse events. 75 67. alex r. kemper et al., expected adverse events in a mass smallpox vaccination campaign, s .effecnveclinicalprac. 84,85 (2002). 68. neff et al., supra note 33, at 1903. 69. sepkowitz et al., supra note 33, at 443-45; neff et al., supra note 33, at 1904. 70. neff et al., supra note 33, at 1903. 71. kemper et al., supra note 67, at 86. 12./d. 73. news release, depi'. of health & human servs., hhs announces contracts to develop safer smallpox vaccines (feb. 25, 2003), available at http://www.bhs.gov/news/pressl 2003presl20030225.htjnl. 74. letter from congressman henry waxman to president george w. bush 1 (jan. 17, 2003), availableathttp://www.house.gov/reformlminlpdfslpdf_comlpdt:._health_vaccine_small pox_bush_letpdf. 75. statement of rep. henry a. waxman on the introduction of the smallpox vaccine compensation and safety act of 2003 (feb. 13, 2003), available at http://www.house.gov /reform/minlpdfslpdf_com/pdf_homeland_securityjegis_state.pdf. 12 indiana health law review [vol. 1:1 on march 5, 2003, the department of health and human services ("hhs") announced its own compensation proposal. 76 the hhs proposal was modeled on the public safety officers benefit ("psob") plan. it created a system of specific dollar amounts to be offered to smallpox vaccinees and those injured by exposure to vaccinia in cases of temporary and permanent disability and death. 77 it also created funds to supplement coverage of medical expenses not covered by the individual vaccinees' medical insurance.78 the law that ultimately passed, the smallpox emergency personnel protection act of 2003/9 was built on the hhs proposal. b. current adverse event profile since the initiation of the smallpox vaccination program, the department of defense ("dod") and the cdc have been keeping careful records of adverse events. mter 450,293 vaccinations of military personnel, no deaths have occurred, but two cases of encephalitis and twenty-one cases of contact transfer have been reported. 80 of note, among other possible side effects is myopericarditis, which was not routinely reported during the last smallpox vaccination campaign. 81 a possibility exists that current diagnostic techniques are responsible for identification of these events as coincident with vaccina­ tion. 82 the absence of reported cases of eczema vaccinatum is attributed to rigorous screening practices.83 despite the rigorous screening, however, ten mv -infected men were vaccinated without incident and eighty-five pregnant women were vaccinated. 84 there have been no cases of transmission in the military health care setting from vaccinees to other patients. 85 according to the cdc, during the period covering january 24 to june 20, 2003, 37,802 civilian health care and public health workers were vacci­ nated for smallpox; no deaths have been directly attributed to the smallpox 76. press release, dep't of health & human servs., hhs proposes smallpox vaccination compensation plan (mar. 5, 2003), available at http://www.hhs.gov/news/press/ 2003pres/20030305.html; ceci connolly, smallpox compensation proposed: white house agrees to benefits for health care workers sickened by vaccine, wash. post, mar. 6, 2003, ataol. 77. dep't of health & human servs., supra note 76. 78. /d. 79. smallpox emergency protection act of 2003, pub. l. no. 108-20, 117 stat. 638 (codified as amended in scattered sections of 42 u.s.c.). 80. john d. grabenstein & william winkenwerder, us military smallpox vaccination program experience, 289 jama 3278 (2003). other adverse events reported include: thirty­ eight cases of autoinoculation, thirty-seven cases of myopericarditis, thirty-six cases of generalized vaccinia and one case of erythema multiforme. /d. at 3280-81. 81. /d. at 3281. 82. ld. 83. /d. 84. /d. 85. grabenstein & winkenwerder, supra note 80, at 3281. 2004] 13 vaccination. 86 serious side effects include one suspected case of encephalitis and seventeen suspected cases of myopericarditis. 87 as with the military experience to date, no cases of eczema vaccinatum have been reported. 88 the absence of this side effect has also been attributed to strict screening practices. 89 there have also been no reported cases of vaccinia transmission to a person in close contact with the vaccinee.90 six civilian women have been exposed to the vaccine during pregnancy, and no transmission from vaccinees to other patients has occurred.91 in addition, there has been extensive attention to a number of heart­ related complications. the cdc reports that there have been eight cases of ischemic heart disease to date, including five myocardial infarctions (two fatal) and three cases of angina.92 an investigation as to whether these cases were vaccine-related is ongoing, but to date a link has not been shown. 93 c. cu"ent e.ffons to vaccinate healthcare workers vaccination efforts moved more slowly than anticipated, 94 partly because states were given little time to prepare for the vaccination program. 95 president bush announced his plans in mid-december 2002 and states were to begin vaccinating public health disease investigators and hospital-based teams of health care workers in late january 2003.96 healthcare workers and hospitals raised concerns aboutlackof appropriate mechanisms for compensa­ tion for injury .97 hospitals were also concerned about placing their staff, staff families, and patients at risk of injury in response to an indeterminate threat of a smallpox attack. 98 all of these concerns were compounded by the reports of unanticipated cardiac adverse events among vaccinees noted above.99 finally, concerns about a smallpox attack have also waned as the primary 86. crrs. rjr disease control & prevention, cardiac and other adverse events following civilian smallpox vaccinationu.s. 2003, 52 morbidity &mortality wkly. rep. 639, 639 (2003) [hereinafter cdc, adverse events 1]. 87. jd. confirmed reports of other adverse events include: eight cases of inadvertent inoculation, two cases of ocular vaccinia, and one case of generalized vaccinia. id. at 640. 88. id. 89./d. 90./d. 91. cdc, adverse events i, supra note 86, at 640. 92./d. 93. jd. at 641-42; ctrs. rordjseasecontrol&prevention, cardiac adverse events following smallpox vaccination-united states 2003, 52 morbidity & mortality wkly. rep. 248 (2003). 94. u.s. gen.accountingoffice, ga0-03-578, smauroxvaccination: implementation ofnationalprogramfaces chauenges 4 (apr. 30, 2003). 95. /d.; inst. of med., supra note 64. 96. inst. ofmed., supra note 64, at 2-3. 97. u.s. gen. accounting office, supra note 94, at 21. 98. id. at 18. 99. ault, supra note 9, at 1626. 14 indiana health law review [vol. 1:1 assault on iraq ended. 100 while it is possible that the rate of vaccination may increase again since the program has not been formally halted, any momentum that could have been gained by prospectively addressing these issues may have been lost. ill. ethical and legal concerns in compensation this section traces the key legal and ethical questions to be asked in designing a compensation program. to provide both historical context and concrete examples, we illustrate each concern with past u.s. government compensation programs. a. was the government the actor who caused the harm? under tort law, the tortfeasor pays the victim. the two rationales most commonly offered are compensation101 and deterrence.102 the person who commits a harm should bear the cost of that harm. presumably, the fear of a penalty will have both a specific deterrent effect on the tortfeasor in question and a general deterrent effect on other parties. government compensation programs arguably fit well into this model when the government itself has directly caused harm to its citizens or to others. however, should the federal government fund a compensation program when the harm is directly or indirectly caused by a third party? although not a single coordinated system, crime victim compensation programs are an example of government compensation to victims despite the contribution of others to the harm. 103 every state has a version of this pro­ gram, supported by funds from offenders, state funds, and federal funds authorized by the victims of crime act of 1984 ("voca").104 although eligibility requirements vary, all states have the same basic criteria.105 the victim generally must report the crime promptly to law enforcement, cooper­ ate in the investigation and prosecution of the case, submit a timely applica100. /d. 101. seewiiliaml.prosser,handbookofthelawoftorts 7 (4thed. 1971). 102. see gary t. schwartz, reality in the &o~mic analysis of tort law: does tort law really deter?, 42 uclal. rev. 377, 378 (1994 ); howard a. latin, problem-solving behavior and theories of tort liability, 13 cal. l. rev. 677, 677 (1985) ("the most influential mode of torts analysis in recent decades has treated liability as a mechanism for social engineering in the sense that accident losses should be allocated to particular parties in order to induce efficient cost-minimizing behavior by similarly situated actors. j. 103. see nat'lass'n of crime victim comp. bds. (nacvcb), crime victim compen­ sation: an overview, at http://www.nacvcb.org/articles/overview_pm.html (last visited feb. 2, 2004). 104. ld.; see nat'lass'nofcrimevictimcomp.bds. (nacvcb),programdirectory, at http://www.nacvcb.org/progdir.html (last visited feb. 2, 2004). 105. nat'l ass'n of crime victim comp. bds., supra note 103. 2004] case study of smallpox lmmun1zation 15 tion to the program, and experience a cost or loss not covered by insurance. 106 victims must also generally be innocent of any misconduct that contributed to the injury incurred. 107 state progratns usually cover the same major types of expenses, including medical, mental health counseling, lost wages, lost support, and funeral expenses. 108 despite the breadth of these payment categories, maximum benefits available to victims from the programs generally range between $10,000 and $25,000.109 why should the government compensate people for crimes committed against them not by the government, but by other individuals? one explana­ tion is that the government is acting not out of obligation but out of compas­ sion. many offenders are judgment-proof, and a state fund may be the only way for a victim to recover some expenses from injury. an alternate inter­ pretation is that the state government failed in its duty to protect people from crime. accordingly, it is obligated to compensate crime victims for the harms that they suffered due to lack of adequate law enforcement. another example of. a program designed to compensate citizens for harms not directly caused by government is the federal emergency manage­ ment agency ("fema"). f'£ma was created by president jimmy carter in 1979 to centralize federal emergency and disaster activities. 110 agencies that were combined into fema included not only the agencies working on fire and flood relief, but also the defense department's defense civil preparedness agency. 111 according to fema' s website: [fema' s first director john] macy emphasized the similari­ ties between natural hazards preparedness and the civil de­ fense activities. fema began development of an integrated emergency ·management system with an all-hazards ap­ proach that included "direction, control and warning systems which are common to the full range of emergencies from small isolated events to the ultimate emergency-war."112 fema's responsibility is to prevent and respond to disasters when state and local governments are not sufficient. 113 under the stafford act, 114 the 106. id. 107. /d. 108. ld. 109. id. 110. fed. emergency mgmt. agency (fema), fema history, at http://www.fema. gov/aboutlhistory.shtm (last visited feb. 3, 2004). 111. ld. 112. ld. 113. fed.emergencymgmt.agency,anationptepatedfederalemergeneymanage­ ment agency strategic plan; at http://ww\v.fema.govlpdfllibrarylfema_strat_plan_fy03-08 (append). pdf (last visited mar. 20, 2004). 114. stafford act of 1974,42 u.s.c. §§ 5121-5204 (2003). 16 indiana health law review [vol. 1:1 governor of a state requests that the president declare the state a disaster area,115 and the regional fema office does an assessment. 116 if the president does declare an emergency, available assistance "is limited to immediate and short-tetm assistance, essential to save lives, to protect property and public health and safety, or to lessen or avert the threat of a catastrophe."117 like the crime victim compensation programs, fema involves pay­ ments to individuals and businesses for acts that were not under the govern­ ment's direct control. fema (now incorporated into the department of homeland security118) serves an established role as a supporter of individuals and businesses in stricken communities. here, too, one could argue that government failed in its duty to protect citizens from danger, although weather-related and other natural emergencies are clearly even further from government's control than criminal offenders. the more powerful conclusion, however, is that government responsibility for compensation does not stem solely from government-initiated harms. b. was the harm foreseeable? in negligence suits, the harm must generally be a foreseeable conse­ quence of the tortfeasor' s actions in order for the plaintiff to prevail.119 when a suit involves the failure to take precautions to protect another from harm, a finding of negligence requires one to take precautions to prevent only those harms that are foreseeable.120 government compensation programs have frequently recognized a greater level of responsibility to victims where the harms caused were foreseeable at the time of their incurrence. the history of compensation for people who were infected with hiv from the blood supply is fraught with critiques of the federal government's failure to act despite the knowledge that such transmission could occur.121 in 1998, congress established the ricky ray hemophilia relief fund to make "compassionate payments" of $100,000 to people with hemophilia and other clotting disorders who were treated with anti-hemophiliac factor between july 115. id. §§ 5170,5191. 116. id. § 5143(b)(1). 117. fed. emergency mgmt. agency, a guide to the disaster declaration process and federal disaster assistance (oct. 5, 2001), available at http:/1166.112.200.141/r-n­ r/dec_guid.htm. 118. homeland security act of2002, pub. l. no.107-296, § 503(1), 116 stat. 2135,2213 (2002). 119. w.page.keetonet al.,prosserandkeetononthelawoftorts §43 (5thed. 1984). 120. blythe v. birmingham waterworks, 11 ex 781 (ct. of exchequer, 1856) (holding that because severe frost was unforeseeable, it was not negligent to fail to take precautions for it). 121. for a critique of the government's response to lllv in the blood supply, see div. of health promotion & diseaseprevention,inst. of med., hw and the blood supply: an analysis of crisis decisionmaldng (oct. 1995). 2004] case study of smallpox immunization 17 1, 1982 and december 31, 1987 and who contracted ihv. 122 spouses and children who subsequently contracted mv and certain groups of survivors also received benefits. the payouts totaled over $554 million to over 7100 eligible individuals and survivors by the program's closing date for petitions on november 13, 2001.123 although the term "compassionate payments" suggests an altruistic regard for the victims as opposed to a sense of repara­ tion, the government was highly criticized throughout the early to middle 1980s for not taking steps to improve the safety of the blood supply, particularly the systems used to pool clotting factor components. 124 the fore­ seeability of extremely high transmission rates can be seen as a tacit element of the government's role in compensating this community. foreseeability also played a major, explicit role in the retroactive analysis of the government's treatment of workers who mined uranium for the atomic energy commission in the western united states from the 1940s to 1960s.125 the advisory committee on human radiation experiments ("achre"), convened by president clinton in 1994, reported on the uranium miners' continued exposure to high levels of radioactive radon gas despite mounting evidence of very high cancer rates among uranium miners in europe.126 a public health service epidemiological study of the united states miners tracked their exposures but did not engage in clinical intervention or inform the miners of the risk of lung cancer to which they were exposed.127 officials also did not take steps to ventilate the mines in a manner that would have reduced exposure. 128 in assessing the acts and omissions of the government with regard to human radiation experiments, the achre committee identified the foreseeability of harm as the major root of the government's blameworthiness: the committee believes that after 1951, when [find­ ings] established that miners were getting a much larger dose to the lungs than previously suspected, the mine owners, the state governments, and the federal government each had a 122. health res. & servs. admin. (hrsa), ricky ray hemophilia relief fund, at http://bhpr.hrsa.gov/rickyray/ (last visited feb. 3, 2004). 123. ld. 124. see div. ofhealthpromotion&diseaseprevention, inst. ofmed., supra note 121. 125. u.s. dep't of energy, achre report, doe openness: human radiation experiments: roadmap to the project, at http://tis.eh.doe.gov/ohre/roadmap/achre/ cbap12_1.html (last visited apr. 2, 2004). 126. id. 127. id. 128. id. 18 indiana health law review responsibility to take action leading to ventilation of all mines.129 the advisory committee has found no plausible justifica­ tion for the failure of the federal govermn~nt, which is the focus of our inquiry, to adl\ere to these principles. it is clear that officials of the federal government were convinced by the early 1950s that radon and radon-daughj;er concentrations in the mines were high enough to cause lung cancer. the federal government's obligation flows from this tnowledge and its causal link to the mining activity, 130 [vol. 1:1 although the federal government had already established a compensation scheme for uranium miners in the radiation exposure compensation act of 1990,131 the committee recommended expanded compensation that would eliminate stringent exposure-linked eligibility requirements. 132 key to the committee's recommendation was the fore~piljty of the harms caused, given the information available at the time, 133 c. was exposure to the harm voluntary and informed? in tort law, assumption of risk caq. preclude an award to a plaintiff. if a victim knowingly and voluntarily subj~ts herself to the risk of harm, she may not be able to recover for injuri~ incurred.134 some states have compa­ rative negligence schemes that minimize, but do not preclude, defendant liability when a plaintiff was contributorily n~gligent,135 additionally, a plain­ tiff who assumed risk can generally still recover if she can show that the defendant broke a law that was designed to pro~cta class of people of which the plaintiff is a member. 136 in a government cqmpensation program, it is necessary to consider whether a victim's knowledge and voluntary assumption of risk should enhance, hinder, or not f!ffect her ability to recover for her injuries. compensation programs for public safety officers respond in various ways to this issue. most states place public safety officers into special 129. u.s. dep't of energy, achre report, ca. 12: the uaanium miners, at http://tis.eh.doe.gov/obrelroadmaplacbrelcbapl2_2.html (last visited feb. 6, 2004). 130. id. 131. radiation exposure compensation act of1990, pub. l. no. 101-426, 104 stat. 920. 132. u.s. dep't of energy, achre report, supra note 129. 131k . 134. keetonet al., supra note 119, § 68. 135. id. § 67. 136. /d. § 68. 2004] case study of smallpox immunization 19 workers' compensation programs with enhanced benefits. 137 knowledge that police and frrefighting work are dangerous does not diminish the benefits that injured parties could recover. on the contrary, higher benefits are offered both to reward and incentivize choosing these lines of work. in contrast, in most jurisdictions, assumption of risk does preclude public safety officers from recovering under tort law. 138 the "fireman's rule" states that frrefighters and their estates may not use tort law to sue the people whose negligence led to their injuries or death. 139 there are several justifica­ tions for the fireman's rule, one of which is that firefighters voluntarily assume the risk of their jobs and therefore, are not entitled to compensation for any injuries incurred.140 as a california court stated in 1977: the fireman • s rule is based on a principle as fundamental to our law today as it was centuries ago. the principle is not unique to landowner cases but is applicable to our entire system of justice: one who has knowingly. and voluntarily confronted a hazard cannot recover for injuries sustained thereby. 141 d. did the harm occur in the context of an attempt to avert a greater harm? · a basic utilitarian ethical analysis would hold that, all other things being equal, exposing people to harm is justified if a greater harm can thus be averted. however, does ethical justification of the risk exposure absolve those responsible of the obligation to compensate victims? the national vaccine injury compensation program ("nvicp") exists both to provide compensa­ tion to injured vaccinees142 and also to shield the vaccine industry from excessive and unpredictable liability.143 the program involves a table of presumptive injuries for which parents of injured children can seek compensa137. nat'l ass'n of pouce org. (website}, statement for the record of robert t. scully, executive director, national association ofpolice organizations, submitted to the sub­ committee on social security of the committee on ways and means united states house of representatives on may 21, 1998, at http://www.retirementsecurity.org/impactlfestimony/ imp_testnapo.htm (last visited mar. 22, 2004) ("[m]ost governments have recognized that public safety officers need certain protections and benefits in recognition of the nature of their jobs."). 138. keetonet al., supra note 119, § 61. 139. /d. 140. /d. 141. walters v. sloan; 571 p.2d 609, 612 (cal. 1977), superceded by cal. civ. code§ 1714.9 (2004). 142. h.r. rep. no. 99-908, at 6345-46 (1986). 143. /d. 20 indiana healrn law review [vol. 1:1 tion. 144 before the passage· of the nvicp, parents of children injured by vaccines turned to tort law for compensation for their children's deaths or for funds to pay for their care if they were severely injured.145 many polio plaintiffs, for example, sued under theories of manufacturer's negligence146 or breach of implied warranty.147 despite developments partly shielding manufacturers from liability, 148 lawsuits continued through the 1970s and 1980s and were perceived as a threat to the affordability and availability of vaccines.149 the nvicp, while providing a clear mechanism for compensation to children harmed by child­ hood vaccines, also soughtto preserve the nation's vaccine supply and thereby maintain a population-level immunity to various childhood diseases.150 in what is essentially a mandatory childhood vaccination scheme (which mandates certain vaccinations for school attendance and then mandates school attendance), the unfortunate occurrence of side effects among a very small group of children arguably can be justified by the larger goal (and effect) of preventing high rates of illness and death from infectious disease.l5l accord­ ingly, it might be plausible to say that the government has no obligation to compensate these children or their families. by providing a mandatory alter­ native to tort litigation, the nvicp strikes a balance that both acknowledges the ethical obligation to compensate and preserves an effective system of vaccination. 152 in this instance, the ethical obligation to compensate is grounded in concerns about fairly distributing the burdens of what is de facto a mandatory vaccination program. e. can causation, and subsequently legal and/or moral responsibility, be established? in tort law, for a plaintiff to recover, a negligent act must have been a "but-for" cause of harm, and also must have been the proximate cause of 144. u.s. gen.accoun'11ng ofhce,gao/hehs-00-8, v accineinjurycompensation: programchailengedtose'iti..bclaimsquickly andeasr.y 1 (dec. 22, 1999). 145. ld. at 4. . 146. see, e.g., griffin v. united states, 351 f. supp 10 (e.d. pa 1972). 147. see, e.g., gottsdanker v. cutter labs., 182 cal. app. 2d 602 (cal. ct app. 1960). 148. in 1965, the second restatement of torts noted that drugs and vaccines include a particularly high number of products that are ''unavoidably unsafe." restatement (second) of torts§ 402a cmt. k (1965). their marketing and use are "fully justified," but there is no way that injuries can be entirely avoided. the ''unavoidably unsafe" designation, quickly adopted by the courts, theoretically shielded manufacturers from liability if they prepared vaccines properly and gave adequate warnings. /d. 149. u.s. gen. accounting office, supra note 144, at 1. 150. /d. at 4-5. 151. /d. at 4. 152. /d. at 5. 2004] case study of smallpox immunization 21 harm. 153 when the causes of a person's injury or death are multiple or un­ clear, a compensation program must establish a method for determining causation. lax guidelines may help victims, but they deplete a program's resources or dilute its purpose; rigid guidelines can exclude valid recipients from receiving compensation. the nvicp, discussed above, deals with the issue of causation by creating categories of presumptive eligibility, as outlined in the vaccine table.154 if a certain injury or reaction occurs within a certain time period after vaccination, the plaintiff wins. 155 if an injury occurs outside these para­ meters, the plaintiff may present evidence for causation, which the state can counter.156 some cases are fairly easy to win. for example, a child who con­ tracts polio after receiving a polio vaccination in a region without an outbreak was unlikely to have been infected any other way. other reactions are more difficult to prove. for example, many dpt vaccine cases involve children who developed high fevers and seizures. because such problems can be caused by underlying health issues, it can be difficult to prove that the vaccine was the cause of the injury, and the special master can use wide discretion in crediting or discrediting plaintiffs' evidence. 157 workers' compensation laws may also be used by healthcare workers to compensate for a vaccine-related injury. workers' compensation laws are designed to ensure that employees who are injured on the job receive fixed monetary awards without having to litigate their claims against their employers. 158 in this way, workers' compensation is a relatively predictable and reliable safety net for employees when they are injured on the job. 159 most workers' compensation laws also provide employers and co-workers with a certain level of protection by limiting the amount employees can recover from their employers and prohibiting, in most cases, injured employees from suing their co-workers. 160 in essence, workers • compensation is a no-fault system, where an injured worker's own negligence, or the negligence of his or her employer or co-workers, is not put at issue; rather, the injured employee is simply covered for his or her work-related injuries. by turning the focus away from causation, worker's compensation and other no­ fault compensation programs make compensation more predictable and limit the effects of arbitrary or subjective decision-making on the award of funds. 153. n.y. central r.r. co. v. grimstad, 264 f. 334,335 (2d cir. 1920); palsgrafv. long island r.r. co., 162 n.e. 99, 101 (n.y. 1928). 154. u.s. gen. accounting office, supra note 144, at 5. 155. ld. at 6. 156. ld. 157. id. at 30. 158. keeton et al., supra note 119, § 80. 159. ld. 160. id. 22 indiana health law review [vol. 1:1 f. equity concerns equity among plaintiffs or victims is a common legal and ethical issue in litigation and compensation schemes. when plaintiffs litigate cases indivi­ dually, wide variation in awards is common.161 mass tort cases have the potential to mitigate disparities by pooling plaintiffs and distributing awards equitably. similarly, government compensation schemes have the potential to minimize unfairness by addressing reparations at a group level, but inequi­ ties can still occur within and across compensation programs. the 911 fund162 has generated frequent charges of unfairness. central to these critiques are the methods used to calculate certain types of damages. although some are standard, non-economic awards for death ($250,000 for all victims' estates), others vary by individual victim.163 for example, because economic loss is calculated based on state wrongful death law, many formulas that take lost earnings into account will result in higher payments to the families of victims who had higher salaries. this sort of calculation, although common in tort law, is perceived as a great injustice by families of lower-paid victims and by observers who interpret the formula as valuing life discrimina­ torily.164 the ricky ray relieffund165 has also faced charges of unfairness, not based on internal inequalities, but because of its limited scope. although the act provided compensation to hemophiliacs who contracted hiv from blood product transfusions, it did not cover non-hemophiliacs who also contracted hiv from blood: 'when i read the language of their original ricky ray bill, i was furious,' says steve grissom, an army veteran who con­ tracted aids from contaminated blood transfusions in 1985 and who founded the national association for victims of transfusion-acquired aids. 'this bill advanced the notion that only hemophiliacs contracted aids through contami­ nated blood products. we (transfusion victims) never existed, never happened. all the while, many of us were suffering, many more of us died. ricky ray was a good kid. 161. david w. leebron, final moments: damages for pain and suffering prior to death, 64 n.y.u. l. rev. 256, 259 (1989). 162. air transportation safety and system stabilization act§ 403. 163. september 11 victim compensation fund, compensation for deceased victims; distribution plan information (may 8, 2003), at http://www.usdoj.gov/victimcompensation/ distribution_plan.btml. 164. belkin, supra note 1, at 92. 165. see supra note 122 and accompanying text 2004] case study of smallpox immunization i seriously doubt that he, the bill's namesake would have approved.' 166 23 approximately 12,000 nonhemophiliacs contracted hiv from transfusions.167 in 2002, congress considered an act to compensate non-hemophiliacs who contracted hiv from transfusions or their estates in line with the ricky ray act, but bills in both houses seem to have stopped in committee.168 interest­ group politics played a role in the disparity. representatives of the national hemophilia foundation and other hemophilia advocacy groups initially argued that adding transfusion cases would have made the ricky ray act too costly to pass. today, they support efforts to compensate other transfusion victims.'169 such conflicts of interest may be present in any compensation scheme, and the tradeoff of political expediency (i.e., drawing sharp boundaries around the beneficiaries of a program) versus equity should be considered at the time of the program's creation. g. practical concerns with legal and ethical implications although the issues discussed above represent the most pressing legal and ethical questions in the design and implementation of a compensation program, other seemingly logistical concerns have moral elements. the first of these is the source of funds for compensation. if in a given program it is deemed appropriate for the federal government to provide compensation, how will those funds be allocated? in the nvicp, for example, compensation funds are limited. the program allocated funds for injuries incurred before the enactment170 and established a trust fund for injuries incurred after.171 the trust is funded by a 75-cent tax on every covered vaccine sold in the united states. 172 this vaccine-tax system represents a literal distribution of the costs of vaccine-related injuries over the population that receives childhood injuries (although, of course, many of these costs are covered for the population by insurers). this method of distributing the burden may not be available in every context. two related issues are the finiteness of the affected class and the implications for the viability of the program. perhaps the most criticized example of a government compensation scheme is the black lung program, 166. nat'l ass'n of victims of transrjsion-acquired aids, inc., steve grissom relief fund act, available at http://www.navta.org/advoc.hbn (last visited feb. 5, 2004). 167. see inst. ofmed., on. of health promotion &disease prevention, supra note 121. 168. see h.r. 5299, 107th cong. (2002); s. 2219, 107th cong. (2002). 169. nat'lass'n of victims oftransrjsion-acquired aids, inc., supra note 166. 170. 42 u.s.c. § 300aa-15(j) (2003). 171. id. § 300aa-15(i)(2); see 4/so 26 u.s.c. § 9510. 172. u.s. gen. accounting office, supra note 144, at 7. 24 indiana healtii law review [vol. 1:1 which ballooned enonnously from early estimates.173 at issue was not whether coal miners merited compensation, but rather the logic and coherency of the program itself:. · · the black lung program's arbitrary, unscientific use of pre­ sumptions vastly increased the colnpensation paid. this approach was 'the epitome of political manipulation of the pork barrel process under the guise of operating a workers' compensation scheme,' according· to the most exhaustive study of the program to date. kenneth feinberg, perhaps the leading expert on the politics and administration of mass tort compensation programs, notes that congress has taken one lesson away from its experience with the black lung program: 'don't do it again.' 174 the hann in creating a program whose costs vastly outpace its estimated costs is, as the assessment above indicates, the hesitancy on the part of government to engage in any compensation programs at all. furthennore, an unanticipated depletion of funds may prevent allocation of money to those most banned. a third logistical question, and the one with perhaps the clearest ethical implications, is that of the scope of compensation. under tort law, different rationales underlie the various types of damages available. lost earnings, for example, attempt to put the plaintiff in the position she would have held were it not for her injury. punitive damages, in contrast, seek to express moral condemnation of the defendant's act or to create a deterrent effect against future banns. a compensation program can follow tort law in the state of each prospective recipient, or it can establish its own categories of appropriate compensation. these determinations, although at times highly technical, may have serious implications for equity, for the perception of the program, anc;lfor the program's viability and predictability. iv. applying these.issues to a smallpox compensation program in this section, we offer a roadmap for how the above legal and ethical. concerns might be addressed in the creation of a smallpox immunization com­ pensation program. 173. peter h. schuck, mass torts: an institutional evolutionist perspective, 80 cornell l. rev. 941 (1995). 174. ld. at 969 n.124. 2004] case study of smallpox immunization 25 a. who caused the harm the question of whether the government is the actor causing the harm would depend upon the scenario. of course, if a smallpox attack occur8, it will presumably not be a direct act of the american government. however, the immunization program itself will be, and the question of whether a government policy is the cause of any injuries or deaths that occur must be considered. for example, if the government urges citizens to be vaccinated in the absence of an actual attack, it might take on more responsibility for compensation than if an auack actually occurs. in the latter situation, the harm is arguably caused by the emergency brought about by the attack, rather than by our government. · b. foreseeability as discussed above, some harm is foreseeable in a mass smallpox immunization scheme. rough estimates of the numbers of people affected by known side effects could be made. however, no mass smallpox immuniza­ tions have occurred in the age of mv, chemotherapy, or immunosuppressive drugs. a compensation program would have to ask whether eligibility would only extend to those who experience entirely foreseeable (i.e. known) side effects, or also to those who manifest new responses to the vaccine. as the recent cardiac deaths illustrate, it may be difficult to establish if a certain illness or death is caused by the vaccine, which complicates the foreseeability analysis. c. voluntariness the question of voluntary exposure to harm would be of utmost importance in creating this program. if the government mandated vaccination for any particular group (as it has for portions of the military), coverage of medical and other costs would be a clear moral imperative. however, rules must be established for situations in which people are vaccinated at different levels of voluntariness. should the healthcare workers whom government wanted immunized be compensated because they were urged to get the vaccine, even though they voltinteered? what about citizens who seek access to the unlicensed vaccine that the administration plans to make available? if a smallpox attack actually occurs, are all vaccinations in the appropriate epidemiological area presumptively non-voluntary, or would such vaccina­ tions in fact be formally mandated? the presence of vulnerable subsets in the population complicates the issue of voluntariness. people with weakened immune systems or skin condi­ tions, or those in close contact with them, may have to decide, in advance of a smallpox attack, if they want to be immunized. if people at higher risk of adverse reactions request vaccination despite being informed of their 26 indiana health law review [vol. 1:1 increased susceptibility to injury or death, should they have access to compen­ sation funds? what if these same people are required to accept immunization in the event of an actual smallpox attack? d. causation issues of causation surrounding smallpox vaccination may be complex or simple, depending on the epidemiological scenario. if many people are vaccinated at the same time, it may be difficult to determine whether any resultant injuries were caused by vaccination of the plaintiff or by exposure to others who were vaccinated. because any vaccinia reactions would be from the same mass immunization program, one possibility is not to make any inquiry into the source of infection, but simply to compensate all people who are injured by the vaccine. because the vaccine contains vaccinia and not smallpox virus, there would be no difficulty in distinguishing vaccine effects from the effects of an actual attack, assuming appropriate laboratory facilities are available. e. attempt to avena greater harm in the smallpox context, this issue arises most saliently when a smallpox attack has actually occurred. in this scenario, rapid immunization of large groups of people may be necessary in order to mitigate the spread of an epidemic. screening of vulnerable subsets may not be feasible or desirable. would the government's establishment of a compensation scheme be required in this case, if the harms that occur through immunizations are justified by the need to save large numbers of people? on an individual scale, are any harms incurred outweighed by the individual's own benefit of not contracting smallpox itself? f. equity if a smallpox attack does occur, should those harmed by the vaccine be compensated while those who contract smallpox itself are not? should people harmed indirectly be compensated? what subgroups of the population might be less likely to seek and receive compensation (consider undocumented immigrants), and how might this inequity be addressed? g. awards: funding, finiteness, and calculations: where would the funds for a . smallpox vaccine injury compensation program come from, and would benefits be capped? would the economic costs of a program be predictable at the outset? if not, could the funds from which awards are made be somehow tied to the number of vaccines adminis­ tered (e.g., through a tax)? finally, how should benefits be calculated? 2004] case study of smallpox immunization 27 should compensation include just death benefits and medical expenses, or also future earnings and other economic loss? v. conclusion the questions asked above are intentionally left unanswered. in the context of any national tragedy or government attempt to avert or mitigate such a tragedy, they should be asked, and answered through a thoughtful and transparent process. this should happen not just in the sphere ofbioterrorism, but for any harm that affects americans on a large scale. the ethical impera­ tive is not to answer the questions in a certain way, but to ask them at all, and to do so before rushing into a potentially risky program. more bite than bark: the legal and social consequences of microchipping individuals with alzheimer's disease elizabeth g. currid* ii. a description: meet tile human-implantable microchip •. 359 a. the technology: what makes it tick ...................................... 359 b. the procedure: method behind the madness ......................... 360 c. the history: from 9/11 to alzheimer's disease ..................... 360 d. benefits: sign me up ............................................................... 361 e. technological and procedural problems: loose screws and crossed wires .......................................................................... 362 ii. legal history: from whence we come ..................................... 364 a. rfid legislation: where is it? ............................................... 364 1. federal rfid legislation ................................................. 365 2. state rfid legislation ...................................................... 365 b. rfid case law: courts as mia ............................................. 367 iii. other influential areas of law: a hint of what's to come .............................................................................................. 369 a. electronic surveillance and wiretapping: can you hear me now? ........................................................................................ 369 b. gps: locating answers .......................................................... 371 n. potential privacy problems: opening tile door for intrusion ...................................................................................... 371 a. fourth amendment ................................................................... 372 1. subjective expectation ....................................................... 373 2. reasonableness .................................................................. 374 b. fifth amendment ...................................................................... 375 c. due process clause ................................................................. 3 77 v. other considerations ............................................................... 3 79 a. consent .................................................................................... 379 b. power of attorney .................................................................... 381 vi. solution: forcing tile states into the limelight ............... 382 vll. conclusion .................................................................................. 383 • j.d. candidate, 2009, indiana university school oflawindianapolis; b.a., 2006, butler university. 358 indiana health law review [vol. 6:357 i. introduction: big brothe~ where art thou? since the dawn of the computer age, authors and commentators have warned society about the potential pitfalls associated with the emergence of new technology. 1 zbigniew brzezinski, national security advisor to president carter, even deemed the new technological age ''the major source of contempo­ rary change."2 a number of societal problems, however, may accompany these wide-scale technological advances. 3 the technetronic era involves the gradual appearance of a more controlled society. such a society would be dominated by an elite, unrestrained by traditional values. soon it will be possible to assert almost continuous surveillance over every citizen and maintain up-to-date complete files containing even the most personal infor­ mation about the citizen. these files will be subject to instantaneous retrieval by the authorities.4 the human-implantable microchip, the newest member of the data-storing family and cousin to the global positioning system ("gps"), may fulfill these orwellian predictions and give big brother the perfect means by which to start watching. this note addresses the legal and social concerns resulting from implanta­ tion in alzheimer's patients, arguing in favor of strict legislation as a precautio­ nary measure. in part ii, this note provides background information on the human-implantable microchip, briefly describing the technology, the procedure used in implantation, the resulting benefits, the technological and procedural problems, and the means by which it has gained publicity. part m examines the law's limited response to the human-implantable microchip, especially in light of implantation in alzheimer's patients. part n compares microchipping to other closely-related fields. in part v, this note identifies the legal and so­ cial problems that may result from microchipping. finally, part vi sets out a remedial proposal which urges each individual state to highly regulate micro­ chipping for the sake of the elderly population. 1. see generally nathan brooks. information privacy, 54 federal lawyer 4 (2007). 2. zbigniew brzezinski, beiween two ages: america's role in tile technetronic era 9 (1970). 3. see generally conspiracy research, http://www.conspiracyresearcb.org/forums/ index.php?act=print&client=printer&f=so&t=43349 (last visited january 2, 2009). 4. /d. 2009] microchjpping indniduals with alzheimer's disease 359 ii. a description: meet the human-implantable microchip a. the technology: what makes it tick human-implantable microchips employ radio frequency identification ("rfid") technologies, which "utilize radio waves to automatically identify individual items. ,,5 on the most basic level, an rfid taf and an electromagnet­ ic reader form the two main parts of an rfid system. rfid tags differ de­ pending on the type ofrfid technology used; human-implantable microchips are inserted under the skin and the reader is either handheld or mounted on the wall, usually in a hospital. 7 for these passive tags, 8 the detection and scanning range varies between one and ten feet. 9 although not utilized in current hu­ man-implantable microchips, an active tag boasts a read range of over 100 feet. 10 more specifically, the rfid tag, or a capsule about the size of a rice grain, connotes the stereotypical human-implantable microchip. 11 it is impor­ tant to note that the microchip, as currently marketed, only stores an electronic id and does not possess tracking capabilities. 12 the rfid tag utilizes the electronic product code ("epc") to hold the in­ formation within the confines of the tag. 13 the epc system in most micro­ chips, not just specifically in human-implantable microchips, rivals that employed in universal product codes ("upc"s).14 however, "upc barcodes can only store seven bits of information, [while] epc rfid tags can store up to 256 bits. in fact, the epc system has enough capacity 'to provide unique iden­ tifiers for all items produced worldwide. '"15 the epc system in human­ implantable microchips is read-only, whereas other epc systems may allow for read-write or read-write and tracking.16 the reader, however, is the true power 5. verichip corporation, rfid 101, http://www.verichipcorp.com/content/company/ rfidlol (last visited november 12, 2007) [hereinafter rfid 101]. 6. id. 7. veri chip corporation, rfid tags, http://www. verichipcorp.com/content/ company/rfidtags#implantable (last visited november 12, 2007) [hereinafter rfid tags]. 8. passive tags "are not powered by a battery, but instead rely on power generated by the reader." rfid 101, supra note 5. 9. rfid 101, supra note 5. 10. id. 11. see rfid tags, supra note 7. 12. id. 13. see reepa1 s. dalal, chipping away at the constitution: the increasing use ofrfid chips could lead to an erosion of privacy rights, 86 b.u. l. rev. 485,487 (2006). 14. id. 15. id. 16. see generally elaine m. ramesh, time enough? consequences of human microchip implantation, 8 risk 373, 378 (1997) (describing the forms of implantable microchips). a read-write microchip ''would be capable of carrying a set of information which could be ex­ panded as necessary." i d. a read-write and tracking microchip would have all the capabilities of a read-write microchip, as well as the ability to "emit a radio signal which could be tracked." i d. 360 indiana heal1h law review [vol. 6:357 source.17 human-implantable microchips utilize passive rfid technolofl; therefore, they only activate in response to signals produced by the reader. b. the procedure: method behind the madness simpl~ put, the microchip is inserted beneath the skin through a shot-like procedure.1 "after a local anesthetic is administered, a large-gauge, hypodermic needle injects the chip under the skin on the back of the arm, midway between the elbow and the shoulder.'.2° after insertion under the skin, the microchip may be scanned by a reader?1 the passive nature of the rfid tag requires the reader to emit energy to bring the dormant microchip to life. 22 in response, the chip transmits the tag's verification number that may be used to obtain personal informationusually medical in nature-from a computer da­ tabase?3 c. the history: from 9/11 to alzheimer's disease rfid technology originated during world war ll when the british "relied on rfid signals transmitted by their own aircraft to confirm their identity. ,,24 in the 1970s, cattle ranchers began to microchip their livestock to track grazing and reproductive habits.25 eventually, other animals became susceptible to mi­ crochipping, and "[i]n the 1990s, millions of chips were implanted in livestock, fish, pets, even racehorses. ,,26 rfid technology came into vogue when the first rfid tags based on mi­ crochips infiltrated the marketplace in the 1980s?7 for-profit companies found microchips to be useful, placing them in a variety of inanimate objects, particu­ larly as a vessel to monitor "the flow of goods and increase efficiency.'.28 the burgeoning microchip industry soon realized an even bigger potential market in the implantation of human beings. 29 the v erichip corporation 17. seerfid 10l,supranote5. 18. ld. 19. cnn.corn, microchips in humans, http:/lwww.cnn.com/2007ffecwscience/08/ 0 1/chips.humans.ap/index.html (last visited november 12, 2001) [hereinafter cnn, microchips in humans]. 20. id. 21. rfid tags, supra note 7. 22. id 23. ld. 24. gal eschet, f/ps and pets for rfid: protecting privacy in the web of radio frequency identification, 45 jurimetrics j. 301, 307 (2005). 25. cnn, microchips in humans, supra note 19. 26. id 27. eschet, supra note 24. 28. see kristi heirn, microchips in people, packaging and pets raise privacy questions, seatil..e times, oct. 18, 2004, available at http://seattletimes.nwsource.com/html/business technology/2002066022_chipprivacy18.html [hereinafter heim, microchips in people]. 29. see generally id (presenting a timeline of microchipping, including the market's 2009] microchipping individuals with alzheimer's disease 361 ("v erichip") established itself as the frontrunner in this arena, tracing its origi­ nation back to september 11,2001, "when new york firemen were writing their badge id numbers on their chests in case they were found injured or un­ conscious.'.30 applied digital capitalized on this need for more elaborate iden­ tification methods and created the v erichip corporation as a wholly-owned subsidiary in december 2001.31 roughly three years after its creation, veri­ chip received fda approval for its human-implantable microchip in medical applications. 32 the verichip corporation is currentll the only company in the world today offering an fda-approved microchip.3 the company's revenues reflect its growing recognition. v erichip reports a sale of7,000 microchips worldwide, 2,000 of which have been implanted in humans. 34 currently, most ofv erichip' s sales have occurred internationally.35 for instance, the attorney general ofmexico and members ofhis staff use the microchip as a security pass to access secured areas.36 the company hopes to broaden its market, and is presently campaigning for implantation in supposed high-risk patients, particularly individuals with diabetes or alzheimer's dis­ ease.37 d. benefits: sign me up human-implantable microchips benefit society in a variety of ways. for instance, human-implantable microchips can restrict access to certain buildings or serve as an anti-kidnapping device for young children. 38 in fact, officials · established such child-protection services in mexico?9 also, it may aid em­ ployers in determining if job applicants have a criminal background or are le­ gally present within the country.40 most importantly for verichip's newest campaign, human-implantable microchips may be used to scan unconscious patients to gain access to their medical history.'n move toward human-implantable microchips). 30. see verichip corporation, company profile, http://www.verichipcorp.com/ company.html (last visited november 12, 2007). 31. /d. 32. /d. 33. !d. 34. cnn, microchips in humans, supra note 19. 35. see laurie barclay, md., medscape today, fda approves implantable chip used to access medical records, http://www .medscape.comfviewarticle/491994 (last visited november 12, 2007) [hereinafter medscape today]. 36. see id. 37. see cnn, microchips in humans, supra note 19. 38. see eschet, supra note 24, at 309. 39. seeid. 40. seeid. 41. seeid. 362 indiana health law review [vol. 6:357 e . . technological and procedural problems: loose screws and crossed wires although human-implantable microchips benefit society in a number of ways, microchip technology and the procedure behind implantation and retrieval of information also bring about many difficulties. first, although the fda found "reasonable assurance" in the safety of human-implantable microchips distributed by v erichip, some commentators fear that health risks may exist nonetheless.42 in a letter from the fda to applied digital solutions that granted fda approval, the administration listed various potential health risks, including "adverse tissue reaction, migration or failure of the implanted transponder, compromised information security, failure of the inserter or scan­ ner, electromagnetic interference, electrical hazards, magnetic resonance imag­ ing incompatibility, and needle stick.'.43 chip migration occurs because ''t]he capsules can migrate around the body or bury themselves deep in the arm. when that happens, a sensor x-ray and monitors are needed to locate the chi.f.j and a plastic surgeon must cut away scar tissue that forms around the chip.' furthermore, "[a] series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had 'induced' malignant tumors in some lab mice and rats.'.45 the study, however, presents several caveats. not only may results differ between animals and humans, but also millions of animals underwent microchipping without developing cancer.46 des.gite these caveats, leading cancer specialists still find the statistics worrisome. several leading critics have alleged administrative impropriety regarding fda approval of the chips.48 the associated press reported: the fda is overseen by the department of health and human services, which, at the time ofverichip•s ap­ proval, was headed by tommy thompson. two weeks after the device's approval took effect on jan. 10,2005, thompson left his cabinet post, and within five months was a board member of verichip co~ •... he was compensated in cash and stock options. 9 second, the technology's relative permanence may substantially inconvenience 42. todd lewan, chip implants linked to animal tumors, wash. post, sept 8, 2007, available at http:/lwww.washingtonpost.com/wp-dyn/content/article/2007 /09/08/ ar200709 0800997 _pf.html 43. medscape today, supra note 35. 44. cnn, microchips in humans, supra note 19. 45. lewan, supra note 42. 46. see id. 47. seeid. 48. seeid. 49. id 2009] m:icrochjpping individuals with alzheimer's disease 363 a patient. "with an implantable chip, the person who's being tagged really doesn't have the ability to remove the tag or control the disclosure of its identity."50 also, if an individual wants to remove the microchip, research shows that it cannot be easily or painlessly taken from the body. 51 third, opponents ofhuman-implantable microchips seemingly disregard potential health risks and potential discomfort caused by the chip's pennanence. 52 instead, they worry about unauthorized individuals gaining access to a chip's supposedly-guarded information. 53 in essence, they argue that companies have not perfected the technology to prevent abuses. 54 thieves can actually engage in "spoofing," where they ''make their own readers, aim them at unsuspecting individuals, and surreptitiously pluck people's ids out of their anns.'.ssln one example underlying these concerns, security researcher, jonathan westhues, "cracked" the verichip human-implantable microchip in less than two hours.56 "westhues was able to read and clone the chip in the ann of a wired news reporter in mere hours with a reader the size of an mp3 player and an antenna about five inches long.'.s7 subsequent to his first crack of the verichip, westhues demonstrated that even smaller technology-with a price tag of about twenty dollars-may access the verichip.58 not only may the verichip's information be accessed, but the chip itself may also be cloned. 59 "once the v erichip is read and cloned, the copy could be used for whatever purpose was intended for the initial chip, whether it be identifying a patient or accessing a secured location.',oo verichip's own chief executive officer admitted to the relative ease in stealing the sixteen digit id number from others. 61 greater difficulty presents itself, however, in attempting to gain access to the database where the company stores the information that correlates to the number.62 for the technologically­ savvy, breaking into a password-protected database might not prove an insurmountable task. a student in the netherlands demonstrated this potential threat by writing a virus small enough to fit on an rfid tag in only four 50. heim, microchips in people, supra note 28 (quoting marc rotenberg, director of the electronic privacy information center in washington, d.c.) (internal quotations omitted). 51. see cnn, microchips in humans, supra note 19. 52. see, e.g., medscape today, supra note 35 (deemphasizing health risks while discussing non-biological concerns). 53. cnn, microchips in humans. supra note 19. 54. seeid. 55. id. 56. nicole a ozer, rights chipped away: rfid and identification documents, 2008 stan. tech. l. rev. 1, 13 (2008). 57. /d. 58. id. 59. id 60. id 61. cnn,microchipsinhumans.supranote 19. 62. seeid 364 indiana heallh law review [vol. 6:357 hours. 63 corruption of an rfid tag with a virus could allow a hacker access to any data stored on an institution's computer system by rendering the databases defenseless. 64 in addition, rfid tags may share problems with biometric passports, "because the biometric information is broadcast 'in the clear' rather than in encrypted formats that avoid transmitting the information to unautho­ rized readers. ,,6s a fourth kind of difficulty countering the benefits of the microchips is that hospitals and emergency medical centers must evolve technologically if microchipping gains popularity. according to verichip, by the beginning of august 2007, it had only trained and outfitted 100 hospitals around the country with the electromagnetic reader.66 the government reported 4,927 community hospitals located in the united states in 2002.67 thus, only about two percent of all hospitals currently possess the requisite technology to employ the human­ implantable microchips. the burden of bringing all relevant organizations up to speed would include the substantial price of this equipment. for instance, one high-powered reader for a passive tag costs between $1,000 and $3,000-a significant amount that does not account for the other expenses incurred in updating to rfid technology.68 finally, although the current fda-approved version of the chip possesses no tracking capabilities, other versions of the human-implantable microchip may enable monitoring of a person's whereabouts.69 "if each chip emitted a signal of a unique identifying frequency, implanted individuals could be tracked by simply dialing up the correct signal. the implantable microchip could be monitored from the police station, a car or perhaps even a helicopter .. • • " 70 such a possibility may seem remote, but in fact, biomedical researchers currently track animals with analogous devices. 71 ii. legal history: from whence we come a. rfid legislation: where is it? rfid technology has been utilized for several decades. 72 it has primarily 63. kristina m. willingham, scanning legislative efforts: current rfid legislation suffers from misguided fears, it n.c. banking inst. 313, 319 (march 2007). 64. seeid 65. medscape today, supra note 35. 66. cnn, microchips in humans, supra note 19. 67. press release, u.s. census bureau, statistical abstract of the united states: 20042005, http://www.census.gov/press-releaselwww/releases/archiveslhealth_tablel58.pdf(last visited feb. 20, 2009). 68. see rfid 101, supra note 5. 69. see ramesh, supra note 16, at 374. see also cnn, microchips in humans, supra note 19. 70. ld. at 385. 71. jd. 72. see rfid journal, is rfid new?, http://www.rfidjoumal.com/fuq/16/52 (last visited 2009] microchipping individuals with al.zhejmer.'s disease 365 focused, however, on implantation of inanimate objects. 73 thus, legislatures have had time to fashion laws to protect these industries, as well as consumers, against abuses. 1. federal rfid legislation despite the existing rfid legislation, the federal government has failed to deal directly with rfid technology. 74 in 2004, the opt out ofid chips act ("ooica") made its way to congress. 75 ooica would have required compa­ nies to place a warning label on all rfid-tagged products detailing the pres­ ence of an rfid tag and would give consumers the option to remove or disable it. 76 the bill, however, failed to garner support and died in a house commit­ tee.77 in 2005. the federal government acknowledged rfid technology in the real id act. 78 the legislation requires that state drivers' licenses conform to a set of federal standards. 79 although the federal guidelines do not require the inclusion ofrfid tags in drivers' licenses, they do allow the secretary of ho­ meland security to impose such a condition if so desired. 80 some analysts ar­ gue that the secretary will indeed pursue this course of action. 81 2. state rfid legislation unlike the federal government, states have been far more willing to regu­ late rfid. 82 many legislators have attempted to pass state rfid legislation in hopes of influencing future federal action. 83 since 2004, five states-new hampshire, utah, virginia, wisconsin, and wyoming-have enacted rfid lef­ islation. 84 also, a number of other states have proposed rfid legislation. 5 furthermore, the states • governors have not hindered the legislature. 86 only governors in california and rhode island have vetoed rfid legislation. 87 nov. 3, 2007). 73. seeid 74. see willingham. supra note 63, at 326. 75. see laura hildner, defusing the threat of rfid: protecting consumer privacy through technology-specific legislation at the state level, 41 harv. c.r.-c.l. l. rev. 133, 151 (2006). 76. see/d. 77. see/d. 78. see willingham. supra note 63, at 327. 79. seeid. 80. seeid 81. anita ramasastry, cnn.com. why the 'real id' act is a real mess, http://www.cnn.com/2005/la w/08/12/ramasastry.ids.fmdex.html (feb. 20, 2009). 82. see willingham, supra note 63, at 327. 83. seeid. 84.seeid 85. seeid 86. seeid 87. seeid. 366 indiana health law review [vol. 6:357 for the most part, legislation tends to fall into three 1eneral categories: "restrictive, disclosure, or extreme privacy legislation."8 living up to its name, restrictive legislation places restrictions or conditions on the use ofrfid technology. 89 the identity information protection act of2006 ("lip a") serves as an example. 90 among a number of other provisions, lip a requires "that there must be mutual authentication between the rfid tag and the rfid reader when personal information is being transmitted."91 . similar to ooica, which never made it out of committee, state disclosure legislation requires those employing rfid to tell their consumers of its use. 92 this may be accomplished by placing signs near an rfid reader, informing a customer of the location of all readers via writing, or through a website. 93 oth­ er stipulations may also apply: [ d]isclosure legislation may also require that any product containing an rfid tag bear a symbol or label that noti­ fies the customer that the product contains an rfid tag. a new hampshire bill goes one step :further by stipulat­ ing that any product containing an rfid tag must bear a "universally accepted symbol" that indicates the pres­ ence of an rfid tag. 94 finally, some states have adopted extreme privacy legislation, most dis­ cussing human-implantable microchips.95 simply put, extreme privacy legisla­ tion "assumes the worst possible uses of rfid and then attempts to preemptively regulate them."96 wisconsin recently enacted a frohibition against any person forcing another individual to be microchipped.9 both ohio and missouri legislatures have introduced acts that would forbid employers from requiring employees to be implanted with an rfid tag.98 likewise, even though the governor ultimately vetoed the proposed acts, the rhode island leg­ islature passed a number ofbills disallowing state agencies and municipalities from using rfid to track its citizens. 99 most recently, oklahoma made the headlines with its proposed rfid leg­ islation, with some legislators advocating for microchip implantation in human 88. willingham, supra note 63, at 328. 89. seeid 90. seeid 91. see id. at 328-29. 92. see id. at 326, 333. 93. seeid 94. willingham, supra note 63, at 326. 95. see id at 331. 96. /d. at 332. 97. /d. at 331. 98. see id. at 332. 99. see id at 327-28. 2009] microchipping individuals with alzhe1mer.'s disease 367 beings, specifically in individuals convicted of violent crimes.100 ''the meas­ ure, approved by the senate, authorizes microchip implants for persons con­ victed of one or more of 19 violent offenses who have to serve at least 85 percent of their sentence." 101 the legislation, however, was sent back to com­ mittee, but onl~ after legislators raised a variety of concerns about violation of civilliberties.1 2 no matter what type oflegislation a state enacts, the compul­ sion to regulate microchipping is unlikely to dissipate, especially since current legislation indicates an overall sentiment that rfid is "'a risky technology re­ quiring specific regulations to prevent identity theft' and protect privacy."103 b. rfid case law: courts as mia although several state legislatures have delved into the world ofrfid, few litigated cases make reference to the technology, including human­ implantable microchips. in fact, the sponsor of the privacy-conscious wiscon­ sin law admitted that no known cases of forcible implantation of an rfid tag • 104 ext st. despite the scant case law dealing with microchipping, two cases in par­ ticular briefly discuss it. the first, state v. 1993 chevrolet pickup, demon­ strates widespread fears accompanying rfid technology and microchipping, specifically of a surveillance empire ofsorts.105 in 1993 chevrolet pickup, agents from the eastern montana drug task force raided several unlocked trash cans belonging to the defendant, a suspect who was thought to be operat­ ing a methamphetamine laboratory.1 06 items found in the ~~e cans formed the basis for a search warrant of the defendant's belongings.107 subsequent to the search, the agents arrested the defendant.108 in tum, the defendant argued against the legitimacy of the search warrant.109 the montana supreme court held that the search warrant was valid, based on the agents' raid of the defen­ dant's trash cans.110 the court based its decision on the lack of privacy inhe. · ill rent m society. 100. see kosu, house rejects forced microchip implants for violent criminals, http://www.publicbroadcasting.netjkosu/news.newsmain?action=article&article _ id= i 08726 5&sectionid=1 (last visited nov. 12, 2007). 101. jd. 102. see id. 103. willingham, supra note 63, at 335 (quoting douglas b. farry, rfid product news, does california's new legislation ignore advantages ofrfid?, http:// www.rfidproduct news.com/issues/2006.09/ lega1.php (last visited feb. 3, 2007)). 104. jd. at 331-32. 105. state v. 1993 chevrolet pickup, 116 p.3d 800, 806 (mont. 2005). 106. jd. at 802. 107. jd. 108. jd 109. ld. 110. ld 111. see 1993 chevrolet pickup, 116 p.3d at 806. 368 indiana realm law review like it or not, i live in a society that accepts virtual strip searches at airports; surveillance cameras; "discount" cards that record my buying habits; bar codes; "cookies" and spywear [sic] on my computer; on-line access to sa­ tellite technology that can image my back yard; and mi­ crochip radio frequency identification devices already implanted in the family dog and soon to be integrated in­ to my groceries, my credit cards, my cash and my new undetwear.112 [vol. 6:357 this lack of privacy can similarly be imported into the microchipping context the dissent in rise v. state of oregon, however, provides a hint of the le­ gal problems that may arise in the future, particularly in regards to microchip­ ping.113 in rise, prison inmates brought a claim against the state of oregon, protesting the state's requirements that blood be extracted from certain inmates for dna testing and the results be recorded in oregon's dna data bank.114 although the case has since been overruled, the dissent presented the only ex­ isting case law mentioning human-~lantable microchips and the constitution­ al implications from such a practice. 5 today, technology allows us to insert a microchip be­ neath the skin and later scan the microchip for a positive identification of the individual. under the majority's analysis, such microchip insertion would be permissible because of its function to identify criminals, even though it violates our precedent regarding the intrusiveness of an invasion ofbodily integrity. as technology develops, there may well be other, more intrusive possibilities for verifying an individual's identity. surely, the fourth amendment's proscriptions against search procedures that invade bodily integrity shield the individual from such intrusions, even though the procedures could yield enormously useful fruits for regular law enforcement purposes. 116 the dissent is worrying about other possibilities beyond even the realm of mi­ crochipping and implies that perhaps the fourth amendment would serve as some sort of protection against the risks inherent in such possibilities. 112. /d. (nelson. j., concurring). 113. see rise v. oregon, 59 f.3d 1556, 1569 (9th cir; 1995). 114. id at 1558. 115. see id. 116. /d. at 1569 n.3. 2009] microchipping individuals with .ai..zheimer's disease 369 ill. other. influential areas of law: a hint of what's to come a. electronic surveillance and wiretapping: can you hear me now? in contrast to the lack oflegislation specifically detailing microchipping, "[t]he federal government and virtually all states have enacted statutory provi­ sions dealing with electronic surveillance and wiretapping. "117 at the federal level, conr:ss enacted the electronic communications privacy act ("ecpa") of 1986.11 "among the goals of the ecpa was a desire to update eavesdrop­ ping regulations to address current technology and avoid unnecessary restric­ tions on then emerging fields of communications technology."119 in an attempt to achieve these ends, congress deemed several acts criminal, including unlaw­ ful access of stored information.120 interestingly enough, the ecpa explicitly states that tracking by way ofrfid technology is an exclusion to the wiretap­ ping rules, a provision which was later upheld by the courts.121 in an effort to keep up with changing technology, congress adopted the communications assistance for law enforcement act (''calea'') in 1994.122 this is the only legislation that even acknowledges location privacy, although it makes no specific mention ofrfid.123 calea actually deals with tele­ phone communications: calea requires telecommunication carriers to make their equipment capable of transmitting "call-identifying information," but it also specifically prohibits the use of technology (other than pen registers and similar devices) that would reveal the user's physical location. the inter­ pretation and enforcement of the statute is delegated to the federal communications commission (''fcc"), making the agency responsible for promulgating proced 1. 1~ ures to ensure comp tance. the fcc's oversight of location privacy "may be extended to cover rfid technology. "125 the fcc's recent policies in regards to location privacy, how117. oleg kobe1ev, big brother on a tiny chip: ushering in the age of global surveil­ lance through the use of radio frequency identification technology and the need for legisla­ tive response, 6 n.c. j. l. & tech. 325, 336 (2005). 118. id. 119. ld. 120. ld. at 337. 121. id. 122. see generally communications assistance for law enforcement act, pub. l. no. 103-414, 108 stat. 4279 (1994). 123. kobelev, supra note 117, at 338. 124. id. (footnote omitted). 125. id. 370 indiana healrn: law review [vol. 6:357 ever, may require a congressional push in the direction of privacy-friendly pol• • 126 lcles. following calea's enactment, the biggest expansion of governmental authority regarding surveillance and wiretapping occurred after the fateful events of september 11, 2001.127 congress passed the uniting and strengthen­ ing america by providing appropriate tools required to intercept and ob­ struct terrorism act ("usa patriot act'}, the intelligence authorization act for fiscal year 2002, and the department of homeland security act of 2002.128 although enacted in different years, federal rfid legislation relates to one another, tied together by a common thread. in short. all of the existing legislative acts in which con­ gress addressed the issue of privacy seem to either spe­ cifically allow or at least tacitly permit virtually unrestricted tracking and monitoring of individuals by both the government and private actors ..•. while in the pre-rfid world this situation was tolerable simply due to the limitations and expense of the available tracking technology, the advent ofrfid, with its cheap and effi­ cient tracking mechanisms and its ubiquity in the mar­ ketplace, greatly magnifies the threat to people's . 129 pnvacy. the supreme court has also addressed electronic surveillance. in katz v. united states, the supreme court held that the united states government vi­ olated the petitioner's rights to privacy under the fourth amendment.130 in his concurrence, justin harlan based his decision on the application of a two-part privacy test to detennine when law enforcement activity constitutes a search.131 the following two criteria must be proven in order for law enforcement activi­ ty to constitute a search: first, a person has exhibited an actual subjective expec­ tation of privacy and second, the expectation is one that society is prepared to recognize as "reasonable."132 subsequently, the supreme court has adopted 126. seeid 127. see id. at 336. 128. see generally the uniting and strengthening america by providing appropriate tools required to intercept and obstruct terrorism act, pub. l no. 107-56, 115 stat. 272 (2001 ); the intelligence authorization act for fiscal year 2002, pub. l. no. 107-108, 115 stat. 1394 (200 1 ); and the department ofhomeland security act of2002, pub. l. no. 107-296, 116 stat. 2135 (2002). 129. id. at 338-39. 130. see katz v. united states, 389 u.s. 347 (1967). 131. id. at 361. 132. id 2009] m!crochipping individuals with alzheimer's disease 371 this formulation in determinin~ government violations of the rights to privacy under the fourth amendmenty3 b. gps: locating answers the gps, a specific type of electronic surveillance, is comparable to the human-implantable microchip in a number of ways. for instance, one of the main criticisms of the microchip-invasion of privac~ rights-has also been a source of controversy in previous battles over gps. 34 gps caused outrage among privacy advocates because it actually "allows law enforcement officials to monitor an individual's precise movements for weeks or months at a time."135 an upside exists, however, because gps stays remote to the individ­ ual, located in cell phones or car navigation systems.136 the human­ implantable microchip, on the other hand, could turn into gps on steroids-a round-the-clock monitoring system completely embedded within a person's bodls. 137 the supreme court has warned about advancing gps to the next lev­ e1.1 8 it has stated that ''the [fourth amendment] rule we adopt must take ac­ count of more sophisticated systems that are already in use or in development." 139 courts have also recognized the privacy implications associated with gps.140 a total of seven courts, three federal and four state, have considered the permissibility of law enforcement's use ofgps-tracking devices, with no clear consensus emerging. 141 "of these seven cases, one declined to resolve the matter and the remaining six split evenly on the question of whether law en­ forcement should be required to obtain a warrant before engaging in the surrep­ titious use of a gps tracking device. " 142 in essence, a clear train of thought has not yet emerged indicating how the supreme court would rule on such a ques­ tion.143 n. potential privacy problems: opening the door for intrusion these several areas of the law, all similar in their own ways to microchip­ ping, have aroused a number of sentiments regarding their constitutionality, 133. kobelev, supra note 117, at 333-35. 134. see renee mcdonald hutchins, tied up in knotts? gps technology and the fourth amendment, 55 ucla l. rev. 409, 409 (2007). 135. !d. 136. see generally id (detailing the science and uses behind gps technology). 137. see id. at 421. 138. kyllo v. united states, 533 u.s. 27, 36 (2001). 139. !d. 140. hutchins, supra note 134, at 445. 141. !d. 142. !d. 143. !d. 372 indiana health law review [vol. 6:357 especially in the area of privacy. due to the comparable nature of electronic surveillance and gps to microchipping, these same problems may potentially arise when human-implantable microchips really find their niche in the world­ wide market. the right to privacy originates from language in the first, fourth, fifth, and ninth amendments, as well as throughout the common law.144 in griswold v. connecticut, the supreme court introduced the concept of the right to privacy as a constitutionally-protected interest, holding that privacy stems from the penumbras in the bill of rights. 145 human-implantable microchips threaten an alzheimer's patient's rights to privacy. although there has been little abuse of the chips, the technology is still in its developmental stages and may present problems in the future. 146 similar to the fears that accompany electronic surveillance, wiretapping, and gps, microchips also produce a number of orwellian visions, a society of mi­ crochipped human beings, constantly monitored by big brother. as previousli mentioned, congress enacted the ecp a in part to avoid eavesdropping. 1 later, with the enactment of calea in 1994 and the usa patriot act, con­ gress even further recognized these privac; concerns.148 in regard to gps, case law has also addressed rights to privacy.14 microchipping will be no exception to the attack on an individual's privacy.1 50 now, instead of just worrying about eavesdropping and gps monitoring, society must worry about the increased likelihood of identify theft or compulsory chipping by the government. the following section addresses potential government abuses of microchipping, even though they may seem improbable right now. a. fourth amendment privacy rights arise from several passages in the constitution. the fourth amendment, for example, protects an individual from unreasonable search and seizure by the government. 151 cases involving electronic surveillance and wiretapping have shown that courts often first attempt to determine whether a person has exhibited an actual, subjective expectation of privacy and second, whether the expectation is one society recognizes as "reasonable."152 144. see ramesh, supra note 16. 145. griswold v. connecticut, 381 u.s. 479, 484 (1965). 146. see, e.g., lynum v. dept. of justice, no. 3:07-cv-1652-b ecf, 2007 wl 3287333 (n.d. tex. nov. 5, 2007) (the plaintiff alleges that microchips were forced into her ears and cameras into her eyes. this case illustrates the type of ridiculous allegations that currently exist with regard to microchip abuse and how few, if any, serious right to privacy claims have actually been brought in regards to the technology.). 147. kobelev, supra note 117, at 336. 148. see id. at 336-38. 149. e.g., kyllo, 533 u.s. at 27. 150. ramesh, supra note 16, at 374. 151. see id. at 391. 152. kyllo, 533 u.s. at 27-28. 2009] microchipping individuals with alzheimer's disease 373 1. subjective expectation the supreme court has examined subjective expectation in a variety of cases, some dealing with bodily invasion and others addressing external ob­ jects.1s3 for example, some courts have examined whether the taking ofblood samples would be unconstitutional under the fourth amendment.1s4 the second circuit, agreeing with a third circuit opinion, tss found that personal information should not be readily accessible and subsequently created a subjec­ tive expectation of privacy.1s6 the court did limit the protection, however, stating that individuals cannot expect to have a constitutionallxfrotected privacy interest in matters that al­ ready exist in the public record. s the supreme court has reinforced this limi­ tation, holding that anything alread~ observable to the public does not qualify for fourth amendment protection.1 8 on the other hand, some courts have de­ clined to follow this precedent.1s9 the court in sherman v. jones addressed the issue of whether revealing an inmate's hn status in the presence of other in., mates violates the fourth amendment.160 the court refused to provide consti­ tutional protection: it may well be sensible public policy to provide legal protection to ensure the privacy of medical records. in­ deed, most persons would so conclude, although perhaps not in all circumstances or for all kinds of medical in­ formation. yet, even assuming that privacy protection should be accorded to an individual's medical informa­ tion, the nature and scope of that protection is more sensibly determined by elected legislators via state or federal statute, rather than by judicial stretching of the constitutional text to reach a subject not explicitly treated in the text.161 existing case law shows a rigid dichotomy.162 if the government forced its citizens to undergo microchipping, some courts would probably strike down 153. ramesh, supra note 16, at 387-88, 390. 154. see scbmerber v. state of california, 384 u.s. 757 ( 1966)(the supreme court held that the search and seizure was reasonable because the individual was convicted and thus subject to greater restraints on liberty). 155. see united states v. westinghouse electric corp., 638 f.2d 570 (3rd cir. 1980). 156. see doev. cityofnewyork, 15 f.3d264,267 (2ndcir. 1994). 157. see id. at 268. 158. see united states v. knotts, 460 u.s. 276, 281 (1983). 159. see, e.g., sherman v. jones, 258 f. supp. 2d 440 (b.d. va. 2003). 160. seeid. 161. id. at444-45. 162. see, e.g., id.; see also doe, 15 f .3d at 264 (the court limited the accessibility of per­ sonal information.) 374 indiana realm law review [vol. 6:357 such a mandate as unconstitutional. people possess reasonable expectations of privacy and assume that information placed on a microchip will not be revealed to others. the microchip is placed within one's body and cryptically protected with passwords, safe~ that would probably not be in place if there were no privacy expectations. 63 indoev. cityofnew york, thecourtfoundaconstitu­ tionally-protected interest in doe's hn status.164 similarly, protections should extend to a microchip with medical information, perhaps information detailing hn status like in the doe case. 2. reasonableness the second prong of the supreme court's fourth amendment analysis looks to the reasonableness offorced intrusion by the govemment.165 in wins­ ton v. lee, the supreme court held that "[t]he reasonableness of surgical intru­ sions beneath the skin depends on a case-by-case approach, in which the individual's interests in privacy and securijr are weighed against society's in­ terests in conducting the procedure •.. .''1 basing its decision on the unrea­ sonable nature of surgical intrusion, the supreme court prohibited virginia from forcing a robbety suspect to undera;o surgery in order for doctors to re­ move a bullet :from the suspect's chest.1 in schmerber v. california, the court looked to ''the extent to which the procedure may threaten the individual's safety or health, the extent of intrusion upon the individual's dignitary interest in personal privacy and bodily integrity, and the community's interest. .. .''168 furthermore, the supreme court deter­ mined that"[ s ]urgery without the patient's consent, performed under a general anesthetic to search for evidence of a crime, involves a virtually total divest­ ment of the patient's ordinary control over surgical probing beneath his skin."t69 privacy advocates may encounter several roadblocks when arguing against the reasonableness of mandatory microchipping. advocates of microchipping could distinguish human-implantable chips :from the type of intrusion the su­ preme court prohibited in lee.110 during microchip implantation, a patient does not receive general anesthesia.171 the health risks involved are debatable, but v erichip asserts that few risks accompany the chip.172 the microchip is 163. see generally rfid tags. supra note 7 (detailing the safeguards put in place for human-implantable microchips). 164. see doe, 15 f.3d at 264. 165. see kyllo, 533 u.s. at 27-28. 166. winston v. lee, 470 u.s. 753, 754 (1985). 167. ld 168. ld see also schmerber, 384 u.s. 757. 169. ld 170. seeid. 171. see cnn, microchips in humans, supra note 19. 172. see v erichip corporation, letter to partners, patients, customers and friends, 2009] microchipping individuals with alzheimer's disease 375 like a mere vaccination, which the government, in effect, requires. 173 in addition, the government has the capacity to establish several reasons for microchipping individuals with alzheimer's disease, not to mention the general population. as stated by the v erichip corporation, microchips aid ef­ ficient;atient identification, an important interest in some medical emergen­ cies.17 nonetheless, this does not take into consideration the nature of the "vaccination." the microchip contains a personal identification number that, if properly entered into a password-protected database, potentially reveals an in­ dividual's personal, medical infonnation.175 courts will undoubtedly be skep­ tical of such a mandate.176 b. fifth amendment in part, the fifth amendment provides that a citizen has immunity from self-incrimination.177 traditionally, the supreme court only applied the fifth amendment to verbal self-incrimination and physical trespass in the area of wiretapping.178 consequently, electronic eavesdropping by government agents did not fall under the protections afforded· by the fifth amendment. 179 the supreme court has since broadened its view of the fifth amend­ ment.180 beginning in silverman v. united states, the court held that the gov­ ernment's insertion of a "spike mike" into a wall of a row house in order to eavesdrop on a conversation violated the fifth amendment. 181 the court based its decision not on trespass, but "'lf?n the reality of an actual intrusion into a constitutionally protected area. "'18 moreover, in katz, the court com­ plete!~ dispensed with the idea that only trespass triggers the fifth amend­ ment. 83 today, the court has expanded fifth amendment protection to include removal of objects from an individual's body.184 inrochin v. california, depu­ ty sheriffs and a hospital physician forced defendant rochin to vomit, which allowed the sheriffs to find two capsules containing morphine.185 rochin was subsequently arrested.186 the supreme court reversed his conviction, finding http://www. verichipcorp.com/fileslletter _scott. pdf (last visited feb. 20, 2009). 173. see generally cnn, microchips in humans, supra note 19 (detailing the microchip's implantation process, which is described as feeling like a shot). 174. see eschet, supra note 24, at 309. 175. see rfid tags, supra note 7. 176. see ramesh, supra note 16, at 387-88. 177. seeld 178. see kobelev, supra note 117, at 332. 179. see id. 180. seeid. 181. see id 182. id at 336 (quoting silverman v. united states, 365 u.s. 505 (1961)). 183. seeid. 184. see ramesh, supra note 16, at 397. 185. see rochin v. california, 342 u.s. 165, 166 (1952). 186. seeid 376 indiana health law review [vol. 6:357 that it was unconstitutional under the fifth amendment, as well as under the fourteenth.187 in his concurring opinion, justice black explained that "a per­ son is compelled to be a witness against himself not only when he is compelled to testify, but also when ... incriminating evidence is forcibly taken from him by a contrivance of modern science:•188 as it stands today, the "privilege against self-incrimination focuses on three basic elements: compulsion, incrimination, and testimonial communica­ tion!'189 assuming that the government compels the gleaning of information from a microchip and the information proves to be incriminating in some way, the crucial question becomes whether the production of the microchip's infor­ mation would qualify as "testimonial" under the fifth amendment. the supreme court has addressed the definition of''testimonial" in sever­ al circumstances.190 for example, in schmerber, the court sustained the ad­ missibility of evidence obtained from a compulsory blood test.191 the court differentiated between the donor/suspect's act, testimony, and evidence to sup­ port its decision.192 in essence, the testimony came from the chemical analysis of the blood, not from the defendant's involvement with the extraction of the blood.193 the supreme court, however, also wrote "[t]hat we today hold that the constitution does not forbid the state's minor intrusions into an individu­ al's body under stringently limited conditions in no way indicates that it permits more substantial intrusions, or intrusions under other conditions."194 in so stat­ ing, however, the court notably did not furnish a set of guidelines by which to measure "more substantial intrusions. "195 in an analogous case, doe, the target of a ~d jury investigation failed to disclose some records of foreign bank accounts.196 the suspect refused to sign a consent order allowing the banks to release any such records to the prosecu­ tor, despite government attempts at compulsion, claiming the right against self­ incrimination.197 once again, the court held that the fifth amendment privi­ lege was not implicated by forcing the target to sign a release of the records because the accused was not being forced "to disclose the contents ofhis own mind."l98 the fifth amendment's privilege against self-incrimination would there­ fore not likely cover microchip implants in humans. in light of schmerber and 187. see id at 174. 188. /d. at 175 (black.j.,concurring). 189. fisher v. united states, 425 u.s. 391, 408 (1976). 190. see, e.g .• schmerber, 384 u.s. at 761. 191. /d. at 765. 192. /d. 193. /d. 194. /d. at 772 (emphasis added). 195. /d. 196. doe, 487 u.s. at 202-03. 197. /d. at 203. 198. /d. at 211 (quoting curcio v. united states, 354 u.s. 118, 128 (1957)). 2009] microchipping individuals with alzheimer's disease 377 doe, the act of implantation itself would not be incriminating.199 a microchip could be viewed in a light similar to that ofblood test evidence or bank records. although the microchip is placed within one's body, the information comes from scannin~ the microchip, not from the patient's actual communication of information. 00 the information is stored on a capsule and does not involve ''the contents of [one's] own mind.'.201 thus, following this discomforting chain of thought, the fifth amendment would not prohibit the government from introducing medical information forcibly recovered from an individual's microchip at trial, no matter how personal or incriminating it may be. c. due process clause while at the new york court of appeals, justice cardozo described the right to privacy and more specifically the right to bodily integrity: "[ e ]very hu­ man being of adult years and sound mind [has] a right to determine what shall be done with his own body.'.2°2 the due process clause of the fourteenth amendment guarantees the personal liberty of americans and protects certain unenumerated fundamental rights and interests. 203 the supreme court has ar­ ticulated that one such fundamental right is aright to privacy, which stems from the penumbras from various provisions of the bill ofrights?04 because priva­ cy is a fundamental liberty interest under the fourteenth amendment, courts apply the strict scrutiny test.205 in other words, courts examine whether a state pursuing a compelling governmental interest requiring the infrin~ent of the right to privacy does so in the least restrictive manner possible. 2 in the past, the supreme court has recognized a number of compelling governmental interests in the area of medical treatment, for which states have narrowly tailored approaches to achieve their objectives. for example, in the famous abortion case, roe v. wade, although the court struck down the crimi­ nal abortion laws at issue, it still established a trimester framework. allowing for abortions in only certain circumstances, thus recognizing the state's co~lling interests in the health of the mother and in the potentiality for human life.207 in a subsequent decision, the court broadened the scope of a state's compelling interests in the area of abortion.208 it held that a state has a compelling interest 199. see ramesh, supra note 16, at 397. 200. see rfid tags, supra note 7, for an explanation ofhow information may be retrieved from a microchip. 201. doe, 487 u.s. at 211; see rfid tags, supra note 7, for a description of the storage capabilities of the human-implantable microchip. 202. schloendorffv. soc'y ofn.y. hosp., 211 n.y. 125, 129 (1914), overruled on other grounds by bingv. thunig, 143 n.e.2d 3 (n.y. 1957). 203. griswold, 381 u.s. at 482. 204. ld. at 484. 205. see id. at 485. 206. seeid 207. roev. wade,410u.s.i13, 162(1973). 208. see planned parenthood ofse. pa. v. casey, 505 u.s. 833 (1994). 378 indiana health law revjew [vol. 6:357 in informing the woman's choice, as well as in the interests already recognized in roe-fostering the health of the woman and persuading the woman to care for the well-being of the fetus.209 proponents of microchipping could use similar arguments to justify fur­ ther intrusion by the government into the privacy realm, perhaps advocating the forced microchipping of alzheimer's patients. the government could po­ tentially avoid the prohibitions of the fourteenth amendment by asserting justi­ fications taken explicitly from both roe and planned parenthood ofse. pa. v. casey, such as the compelling interest in the health of the compromised alz­ heimer's patient.210 specifically, many individuals who receive implants do so to create ease and efficiency in identification and access to medical records. 211 in another arena of medical privacy cases, the supreme court has ex­ amined the putative right to die. in cruzan v. director, missouri department of health, the court held that while a patient may elect to terminate treatment­ including life support-and that failure to abide by that choice would be inhu­ mane, the state had a substantial interest in the patient's health and could rightfully restrict that decision to the patient alone by demanding a clear indica­ tion of the patient's wishes. 212 in making its determination, the court looked to history and tradition in the common law.z13 in a related case, washington v. glucksberg, the court specifically recognized the state's interests in preventing assisted suicide. 214 it held that the state possessed an interest in protecting de­ pressed patients, as well as in preventing a slippery slope of prejudicial or pre­ mature decisions and furthering negative stereotypes about the terminally ill or permanently disabled.215 commentators have questioned the far-reaching im­ pact of the court's decision in protecting the elderlypopulation.216 specifical­ ly, [ s ]uicide especially afflicts the ... elderly. of persons over sixty-five, one in seven suffers from depression but the great majority receives no treatment. elderly persons are apt to hide their symptoms out of shame or fear of seeming weak. doctors often fail to recoflize the signs of depression in their older patients ... 21 the court's analyses from these cases may be applied to potential situa209. id at 846. 210. see roe, 410 u.s. at 113; see also casey, 505 u.s. at 833. 211. see eschet, supra note 24, at 309. 212. cruzan v. dir., mo. dep't ofhealth, 497 u.s. 261 (1990). 213. see id. at 269-79. 214. washington v. glucksberg, 521 u.s. 702, 728-29 (1997). 215. see id. at 730-32. 216. see generally ruth c. stem & herbie difonzo, terminal ambiguity: law, ethics and policy in the assisted dying debate, 17 b.u. pub. int. l.j. 99 (2007). 217. id at 103. 2009] microchipping individuals with alzheimer's disease 379 tions created by abuses in microchippingaizheimer's patients. in actuality, the cases may support a government prohibition against microchipping. as with assisted suicide, elderly alzheimer's patients tend to hide their ~ptoms, mak­ ing it difficult for doctors to accurately render a diagnosis.21 furthermore9 courts would likely follow supreme court precedent and examine tradition. 21 because microchipping has not been established in the nation's tradition and courts are usually wary of bodily intrusion, the fourteenth amendment might actually justify the government in protecting its citizens from the use of hu­ man-implantable microchips. tradi . h . b' . . 220 in c c. tion, owever, ts su ~ect to mterpretation. ruzan, 10r example, the court held that the fundamental right at issue involved the right to die.221 in glucksberg, the respondents tried to define assisted suicide as prop­ erly fitting within the right to die, arguing for protection of the ''personal choice by a mentally competent, terminally ill adult .. .',222 the court, however, re­ fused to adopt this interpretation and classified the interest at issue as "assisting another in the commission of self-murder. ,,223 with regard to microchipping, a court could investigate tradition on a broad scale. instead of looking at the existence of microchipping in the na­ tion's history, a court could analyze tradition in light of the right to make medi­ cal choices or the right to control one's body. depending on a court's interpretation, it could potentially find tradition in the law that supports micro­ chipping. v. other considerations in addition to the privacy issues that may arise because of human­ implantable microchips, other considerations also exist as well. these include concerns about consent and power of attorney. a. consent consent may be one of the biggest potential problems involved in micro­ chipping. informed consent is premised on the principle that every adult indi­ vidual of a sound mind has the right to bodily integrity and the right to control 218. see id.; see also infra pp. 38-42 (discussing consent and difficulties that doctors con­ front in diagnosing alzheimer's disease). 219. seecruzan,497u.s.at269-79. 220. see richard e. shugrue, "a fate wone than death": an essay on whether long times on death row are cruel times, 29 ciu!ighi'on l. rev. 1, 22 (1995) ("the court quite often has invoked tradition as a source of fundamental rights. but what is tradition? is tradition what lawmakers say? or is tradition the custom of a community?"). 221. see cruzan, 497 u.s. at 277. 222. gluclrsberg, 521 u.s. at 708. 223. id at 705. 380 indiana healm law review [vol. 6:357 his or her medical treatment.224 in very limited circumstances, however, an exception to this right exists.225 specifically, this ri~t may be curtailed when the patient presents a danger to himself or to others. 6 when adhering to the established consent doctrine, a physician, who is going to implant a patient with a microchip, first needs to obtain the patient's consent or ~ssion from a person legally authorized to give consent in the patient's stead.227 veri chip's new campaign to implant alzheimer's patients, however, ac­ tually magnifies potential consent problems. for example, "[p]atients with alzheimer's disease and other dementias have high rates of incompetence with regard to [competency] decisions ... .',228 in fact, according to a recent study, "more than half of patients with mild-to-moderate dementia may have impair­ ment, and incompetence is universal among patients with severe dementia. ,,229 it may seem like an obvious solution just to identify which patients re­ questing implantation may be deemed incompetent and then rely on power of attorney to determine the best interests of that individual. identification of in­ competency, however, is not a simple task. 230 "[d]ifferentiating capable from incapable subjects remains an issue despite the aid of standardized tools. more research is needed to understand the relationship between subject factors (per­ formance on ability measures) and categorical judgments about their capaci­ ty.',23t not only does identification of competency cause doctors and researchers alike to throw in the towel, but actual identification of alzheimer's disease in a patient proves complex as well. for example, doctors diagnose many individu­ als with alzheimer's disease after it has pro~ssed beyond its early stage and has already rendered the patient incompetent. 232 this may stem from the fact that "[t]here's no clear-cut line between normal changes and warning signs.'.233 in essence, in attempting to diagnose alzheimer's disease, doctors must differentiate between a mere change in functionality due to normal aging and a change due to actual problems with brain activity. this is a difficult task consi224. see kulak v. city ofnew york, 88 f.3d 63,74 (2nd cir. 1996). 225. seeid 226. seeid 227. see dunlap v. marine, 242 cal. app. 2d 162, 168-69 (2nd dist. 1966); see also chambers v. nottebaum, 96 so.2d 716,718-19 (fla. dist ct. app. 1957). 228. pauls. appelbaum, m.d.,assessment of patients' competence to consent to treat­ ment, 351 new eng. j. med. 1834, 1835 (2007). 229. /d 230. see generally alzheimer's association, what is alzheimer's?, http://www.alz.org/ alzheimers _disease_ what_is _alzheimers.asp (outlining the fuzzy differences between alzhei­ mer's and normal age-related memory changes) (last visited feb. 20, 2009). 231. scotty. h. kim, et at., assessing the competence of persons with alzheimer's dis­ ease in providing informed consent for participation in research, 158 am. j. psychia'iry 712, 712(2001). 232. see alzheimer's association, warning signs of alzheimer's, http://www.alz.org/ alzheimers_disease_symptoms_of_alzheimers.asp (last visited feb. 20, 2009). 233. id 2009] microchipping individuals with alzheimer's disease 381 dering the doctor's limited access to the inner workings of the brain?34 for instance, early-stage alzheimer's disease affects memory, thinking, and con­ centration, characteristics that accompany normal aging as well, although to a lesser extent. 235 also, diagnosis of alzheimer's disease proves tricky for doctors because "alzheimer's patients are quite successful at hiding [their] symptoms ... ',236 in fact, alzheimer's patients typically deny the severity of their problems, even to themselves?37 this makes it difficult for others to perceive the presence of d . '1 . h d . h . 238 a l ementla untt it as progresse mto a muc more senous stage. s a resu t of these problems in identifying alzheimer's disease, a doctor, a patient, or the patient's family may not know to take the next step and question the individu­ al's competency. additionally, the law presumes "competency rather than incompeten­ cy. "239 although this presumption serves beneficial purposes in some cases, in the case of microchipping alzheimer's patients, it only hurts chances for a logi­ cal and competent decision. because of alzheimer's patients' ability to hide their symptoms from others, a court would have no reason to question compe­ tency. even if their competency was questioned, the burden of proof would be on the individual attempting to prove the patient's incompetence for the court to deprive a patient of their ri~t to choose or avoid medical treatment or a proce­ dure like microchipping. 2 subsequently, the verichip corporation's push toward implantation of alzheimer's patients treads on unstable ground. assuming an individual has actually been correctly diagnosed with alzheimer's disease, no set of bright­ line rules exists that will aid in a competency determination. if microchipping should be easily accessible to incompetent individuals, then perhaps patients with extreme forms of debilitating insanity should also be allowed to make de­ cisions about important medical procedures. b. power of attorney power of attorney also raises a number of other potential problems regard­ ing human-implantable microchips. state and federal laws allow for individu­ als to formally authorize someone, perhaps a friend or a family member, to make medical decisions for them when they are incapacitated, imbuing them 234. id. 235. id. 236. harvard health publications, anticipating the future, http://mercksource.com/ ppdocslus!cns!harvard-healtb-reports!merckshr-alzheimers082906/sectionslsect12.htm (last visited february 18, 2008). 237. id. 238. see id 239. r. h. lockwood, mental competency of patient to consent to surgical operation or medical treatment, 25 a.l.r.3d 1439 (1969). 240. see id. 382 indiana health law review [vol. 6:357 with power of attorney. 241 theoretically, this individual should be an advocate for the patient, attempting to ensure compliance with the patient's desires.242 in other words, it should be "someone who will articulate their wishes to providers and who will also provide patients with the needed assistance and support re­ quired to maneuver through the confusing labyrinth of health care delivery.'.243 some patients, whether suffering from alzbeimers or another illness, do not, however, appoint a proxy.244 but will the proxy have the patient's best interests at heart? in light ofhuman-implantable microchips, a proxy may have personal motivations to have a patient chipped-for example, increased ease in caretaking and quick identification. 245 these efficiency concerns may oversha­ dow a patient's wishes. this also opens up the door for more litigation when concerned family members, friends, and other individuals want a say in the , d . . 246 proxy s ectsmns. even if an alzheimer's patient does appoint a proxy through advance di­ rective,247 the advance directive system possesses a number offlaws.248 for example, an advance directive may actually be overridden in some states in very limited cases. 249 thus, even if an alzheimer's patient does not want to be chipped and directs such a prohibition in advance, there remains a slim chance that the patient's proxy could get this mandate overridden at a later date. vi. solution: forcing tile states into tile limelight several approaches may be taken to prevent the problems inherent in hu­ man-implantable microchips. the legislature could act (or not act) in several extreme and opposite ways: it could pass a ban on microchipping humans or it could completely disregard the potential conflicts. the best approach, however, 241. susan werthem, front-end first in line to ensure patients gain needed support: patient advocates help meet patient needs, 16 no. 2 healmcare registration 3, 3 (2006). 242. /d 243. /d. 244. id 245. see eschet, supra note 24, at 309. 246. charles m. key, who will decide?, 42 tenn. b.j. 12, 19(2006). 247. an advance directive details how an individual wants certain medical decisions made if they are unable to make them or gives authorization for someone else to make such decisions on their behal£ 248. seeid. 249. from 2000 to 2005, the terri schiavo controversy raged on. schiavo's husband wanted to remove her feeding tube, but schiavo's parents adamantly opposed removal. thomas mayo stated in the journal of health law that: /d no living will and no other piece of paper known to mankind, will avert the cataclysmic clash of family members who are determined to control the de­ cisionmaking for an incompetent patient ... [i]s it likely that the &hiavo controversy would have been averted ifterri schiavo had simply designat­ ed her husband as her proxy decisionmaker in a durable (or medical) power of attorney? probably not. 2009] microchipping individuals with alzheimer's disease 383 would be to advocate restrictive legislation by the states. 250 state governments would be the most efficient mechanism by which to pass legislation, partially because of their past involvement in actively regulating rfid. 251 without completely squelching this new area of science, safeguards are especially important because the verichip corporation's new publicity cam­ paign targets individuals with alzheimer's disease, as well as their families and caregivers. statutory protection against misuse of the human-implantable mi­ crochip should cover the general population. patients with alzheimer's dis­ ease, however, are often completely defenseless against exploitation.z52 in essence, advocates for the elderly and those with mental disabilities have as­ serted as follows: the shameful history ofbenign and sometimes malig­ nant neglect of persons with mental disabilities is well understood: the deep stigma and unredressed discrimina­ tion, the deplorable living conditions, and the physical and social barriers preventing their integration and full participation in society. countless promises have been made to right the wrongs, but new forms of neglect have always emerged. the mentally disabled have ended up in prison, in equally deplorable adult homes, or on the streets, homeless and destitute, while the wider society h d . 253 as averte tts eyes. as a result, extra care should be given in ensuring their protection. vii. conclusion in summary, implanting individuals with microchips implicates a number of legal and social concerns. for instance, the procedure and technology be­ hind microchipping has not been tested at length and raises a number of policy issues. also, despite the lack oflegislation or case law on human-implantable microchips, similar areas of the law hint at potential problems. specifically, the protections implicit within the text of the constitution may not apply to micro­ chipping, leaving society and individuals with alzheimer's disease open for governmental manipulation. also, consent and power of attorney may add to the complexities ofthe issue. 250. see infra pp. 15-16. 251. see generally kobelev, supra note 117, at 3 39-41 (supporting the idea of more regula­ tion for rfid). 252. see lawrence 0. gostin, international human rights law and mental disability, hastings center rep., (march-apr. 2004), http:/lwww. who.intlethics/en/gostin.pdf (last visited feb. 20, 2009). 253. id. 384 indiana healm law review [vol. 6:357 therefore, in order to protect individuals with alzheimer's disease, state governments should carefully monitor this up-and-coming technology. if a blind eye is turned to the potentiality for chip abuse, especially regarding the elderly population, we could really be "on the verge of creating a surveillance society in america, where every movement, every action some would even claim, our very thoughts will be tracked, monitored, recorded and correlated. ,,2s4 254. cnn, microchips in humans, supra note 19 (quoting barry steinhardt, director of the technology and liberty program at the american civil liberties union in washington d.c). randall r. bevbjerg randall r. bovbjerg is a principal research associate at the urban institute in washington, d.c. he has more than thirty years of experience in public and private insurance; state and local health policy; medical injury, liability, and reform; safety-net issues; and state regulation. trained as a lawyer, earlier in his career he was an insurance regulator as well as a volunteer health planner. he has an extensive record of publications and has recently served on the district of columbia health services reform commission (2001..03), jcaho's taskforce on alternatives to tort litigation (2004-05), and the federation of state medical boards' taskforce on patient safety (2005-present). he has taught courses for duke, johns hopkins, and the universityofmaryland-baltimore county. http://www.urban.org. beyond tort reform: fixing real problems randall r bovbjerg • today's frequent mention of malpractice always brings to mind three persistent policy problems, especially for a health policy analyst of a certain age. the first is the difficulties that physicians and other medical providers periodically face in finding and financing insurance protection against legal claims of substandard care. the second is the continuing reality that preventable injuries occur much too frequently in the course of health care. the third is that tort litigation fails to prevent these preventable injuries and creates liability risk that is hard to insure. this troika of problems has long dominated the three branches of the malpractice system-medical, legal, and insurance. unfortunately, malpractice policy making has always been dominated by two perspectives: activist physicians and plaintiffs' attorneys, each largely acting in self-interested fashion, have battled for thirty years. also unfortunately, only one solution has dominated these policy battles--"caps" on awards and other conventional tort reforms. these limits on tort remedies are consistently and vehemently promoted by physicians and their insurers, with the most success during periods of rapid price increases of malpractice coverage, like the recent past, which reformers term malpractice "crises." plaintiffs' attorneys and some consumer advocates have just as vigorously resisted. tort reform battles were traditionally fought in state legislatures, but have lately become federal as well, even taking center stage in the last presidential election. doctors contend that the legal system is broken and can only be fixed with tough tort reform. lawyers argue that the legal system works well, insurance is what is broken and can only be remedied with tough insurance regulation. however, it is a false dichotomy that either the doctors' or the lawyers' position must be right, and it is also wrong to assume that truth lies between the opposed extremes. this paper argues that long-term progress requires focusing on more central issues--medical performance and whether tort law improves it the long-running doctor versus lawyer battle has distracted attention away from the interests of patients and the public at large in medical improvement. the real problems in insurance, medicine, and law are not much affected by the • j.d., harvard law school; principal research associate, health policy center, the urban institute, washington, d.c. this article grows out of the mcdonald-merrill-ketcham lecture delivered on wednesday, october 6, 2004, at indiana university school of law indianapolis, sponsored by the center for law and health. the author's perspective is solely his own, not necessarily that of the institute, center, or university. 4 .. indiana healrn law review · [vol. 3:1 conventional solutions offered, and· better solutions need to have broader reach. three types of alternative solutions are described in the conclusion. i. doctors vs. lawyers1 a. heat versus light the adversarial battle over tort reform mirrors that of the courtroom. on one side stand physicians and their allies, on the other plaintiffs' lawyers and their allies. as in court, each side tries to sell its story to decision makers­ and their partisan contentions diverge drastically.2 faced with such opposing contentions in many spheres, policy makers can normally assume that the truth lies somewhere between the extremes. but this comfortable assumption does not hold for medical malpractice. the reason is that doctors as potential defendants and plaintiffs' attorneys as repeat litigators have always "owned" malpractice issues and have cast the debate quite narrowly, either for or against tort reform. broader concerns about medical quality and patient safety are invoked but not truly addressed. even apparent outsiders claiming to represent the broader public interest sound very much like the partisan advocates. the heat of the debate obscures how little light it casts on broader problems. arguments have become quite routinized, and their repetition often degenerates into sound bites promoting or attacking an anecdote or factoid of · the day. meanwhile, methodologically questionable studies proliferate, many seeming less like peer-reviewed publications than press releases with citations. unfortunately, the actual positions being promoted or attacked do not differ that much when considered with some perspective. lawyers want to ~ntain the status quo ante ofliability rules, while d0f$lrs satisfied with the same liability system, just somewhat less of it. both sides are motivated to exaggerate the legal system's influence on medical care and patient safety: lawyers claim positive impacts to justify the high expense of litigation, and doctors assert deleterious reductions in access to care and wasteful defensive medicine. 1. with apologies for oversimplifying, this paper uses the. shorthand "doctor" or .. physician" to refer to all medical practitioners and institutions, as well as provider-owned insurers; indeed, it may sometimes include business interests or others that support tort reform. conversely, "lawyer" or "attorney" stands in for "plaintiffs' attorneys" and also includes their allies among "consumer" groups. 2. compare e.g., am. med. ass'n, medical liability reformnow!: a compendium off acts supporting medica/liability reform and debunking arguments against reform(oct. 19,2005),availableathttp:l/www.ama-assn.orglamalpublcategoryn861.html(lastvisitedapr. 7, 2006) with ass'n oftrial lawyers of am., press room: medical molpractice news (2006) (formerly called health careresource center: bringing you the latest information on patient sqfety, medical negligence, and dangerous errors), http://atla.orglpressrooinifacts/ health/index.aspx (last visited apr. 7, 2006). 2006] beyond tort reform: foong real problems 5 b. interests and worldviews why do doctors and lawyers clash? the easy response is that they represent opposing economic interests--potential defendants and likely claimant representatives. further, the dispute is the worst sort of zero-sum game. just as in actual litigation, every dollar won by one side comes out of the pockets of the other, and the process is also highly unpleasant. but the differences seem to go even deeper, and an armchair social philosopher cannot resist speculating further. law and medicine are both ancient, proud, and "alpha dog" professions -each used to being in charge within its sphere of action. physicians particularly seem to hate the loss of control they suffer in depositions and·in courtrooms. 3 doctors also take lawsuits personally4 and despise what they see as the theatricality of well rehearsed testimony and argumentation. lawyers, on the other hand, are trained to maintain distance from any client and pride themselves on their skills in advocacy, sometimes flamboyantly exercised. for physicians, the "great engine of truth" is science as developed through peer-reviewed literature and expert consensus over time; for attorneys, it is cross-examination. s although most seem not to realize it, doctors are also accustomed to a different standard of proof. most of physicians' diagnostic decision making is governed by a high standard of proof; they want ninety­ five percent confidence in a lab's finding that patient x has condition y before ordering costly and potentially risky therapy z. this ninety-five percent standard accords with the criminal-law standard of proof-beyond a reasonable doubt-and physicians implicitly acknowledge this mindset about negligence when they commonly discuss whether someone is "guilty" of malpractice. in the world of personal injury litigation, in contrast, one side must always lose, and for lawyers a nearly fifty-fifty burden of proof seems eminently reasonable. doctors and lawyers differ in their life experiences as well as in their worldviews. in practice, they see very different universes of problems. doctors typically see healthy patients or sick ones who get better. even where mistakes occur in treatment, patients are often unhurt, and usually recover. lawyers see would-be clients who remain quite injured, quite angry, quite threatened by high bills-or all three. 3. randall r. bovbjerg, problems and solutions in medical malpractice: comments onchapterssixandseven,in'theliabjlitymaze:theimpaci'ofliabjlitylawonsafety and innovation 277 (peter w. huber & robert e. litan eds., 1991). 4. even those not sued appear commonly to think "there but for the grace of god go 1." atul gawande, the buck stops with the doc: sometimes blaming the system is fair but in medicine, it can be a dangerous cop out, slate, july 23, 1998, http://slate.msn.com/id/2678 (last visited feb. 16, 2006) (noting this nearly universal reaction to preventable bad outcome). 5. state v. thomas, 421 s.e.2d 227, 232 (w. va. 1992) ("[c)ross-examination is the engine of truth"). see john henry wigmore, evidence at'i'riai.satcommon law§ 1367 (james h. chadbum rev. 1974). 6 indiana health law review [vol. 3:1 physicians are loathe to recognize their own mistakes for many reasons, including fear of being blamed for bad outcomes,6 and a pervasive sense of ''there but for the grace of god go 1," which makes them reluctant to hold colleagues accountable. attorneys are more than willing to find blame, as fault-finding is not only a key to their mental model of accident causation but also the mainspring of their business model. ll. three systems and their problems successful solutions start with good assessments of problems. success­ ful interventions focus on problems that can be solved. malpractice problems arise in three sectors of policy concern: (a) medical care, (b) liability law, and (c) liability insurance. medicine is the central social concern; what patients and the public want is access to good quality care. law purports to ride herd on medical providers, deterring substandard care and assuring compensation for wrongfully injured patients. insurance is what doctors buy to protect themselves from legal costs, and in practice provides the funding and dispute resolution professionals without which the current scope of tort liability would probably not be possible. the following discussion covers these three systems in turn. it starts with insurance, whose problems are what prompt headlines, headings, and legislation. a. liability insurance the most visible problems in medical liability insurance are its periodic crises-that is, difficulties maintaining availability or affordability of coverage for doctors, hospitals, and other caregivers. 7 (see box next page). reduced supply of insurance is a problem because practitioners need coverage to practice, and rapid price increases have increasingly become a problem for practitioners because the advent of managed prices seems to prevent them from quickly passing through increased costs to patients and payors. there is no dispute that since 1999, malpractice premiums have risen markedly. 8 there has also been a sharp decrease in the number of insurers willing to sell in many areas. some insurers have failed and others have withdrawn completely from the market, reducing supply.9 6. jay katz. 'dm silent world of. doctor and patient 199 (1984); rosemary gibson&j.p.singh,wailofsilence:'dmunroidstoryofthemei>icalmlstakesthat kill and injure mlwons of americans xvii (2003) (1992). 7. f. a. sloan et al., suing for medical malpractice 5 (1993). 8. u.s. governmental accountability office (previously u.s. general accounting office), report no. ga0-03-702, medical malpractice· ins.: multiple factors have contributed to increased premium rates 4 (2003), http://www.gao.gov/new.items/d03702.pdf(last visited apr. 7, 2006). 9. kenneth e. thorpe. the medica/malpractice "crisis": recent trendsandthelmpact of state reforms, healthaff., w4-20 (2004). 2006] beyond tort reform: fixjng real problems cycles or crises: a longer term perspective the current period marks the fifth major shock to malpractice insurance since the 1950s.10 after each, the market adjusted, not with a simple return to normalcy but rather with considerable change in market participants, risk-bearing arrangements, and premiums. in the 1950s, the risk of lawsuits for doctors was about one in seven ... per lifetime. now, it is closer to one in seven per year. then, million dollar verdicts against doctors were so rare that they won the successful attorney great renown. now, a million dollars is the median, as (imperfectly) tallied by the jury verdict reporter. then, few hospitals could be sued; today, institutional claims are routine. in the 1950s, medical liability was a sleepy line of coverage, sold by the same carriers that sold doctors other types of insurance to cover their autos, business premises, and so on. in the early and the late 1960s, traditional carriers faced two unexpected rises in claims rates that permanently altered the landscape. in response, first generalist carriers largely gave way to more specialized firms. then medical societies stepped in and began negotiating for quasi-group rates. these changes occurred privately, with no need for legislative action. in the mid-1970s and 1980s, problems rose to state and national attention as claims rates again accelerated unexpectedly driving up premiums, driving out carriers, and prompting medical interest groups to proclaim crises. the biggest medical society affiliated carrier quit the line permanently in the 1970s; the gap in capacity was filled by companies started by medical societies and hospitals associations. in the 1980s, there were fewer withdrawals, but premiums rose and a new policy form of"claims made" policies became the dominant mode of coverage. previously, insurers had sold "occurrence" policies that covered policyholders for all claims arising from occurrences in the policy year-which typically would be filed within two years, but which could under legal exceptions be filed twenty or more years later. the new coverage only paid claims actually filed the same year. this new approach allows insurers to adjust rates to trends more quickly and accurately, but from a policyholder perspective, it offers less protection. in the latest upheaval of the early 2000s, anumber of insurers became insolvent, and some long-time specialist sellers left permanently. departures included the st. paul group, once the world's largest malpractice insurer. some hard-hit states took emergency action to keep coverage available. more medical providers have also turned to unconventional, alternative risk mechanisms such as risk-retention groups or, for hospitals, self insurance. like claims made policies, these arrangements offer somewhat less protection than major carrier coverage: they have less capital for emergencies, and they are not backstopped by state guaranty funds that protect insureds in the case of conventional insurers' insolvency. as ofmid-2005, however, there are signs that the medical liability market is softening and premium increases easing-but premiums will not return to 1990s levels, and providers are bearing more risk themselves. 11 7 10. this account draws upon such sources as patricia m. danzon, medical malpractice: theory, evidence, and pubuc poucy 2-3 (1985); frank a. sloan, randall r. bovwerg & penny b. githens, insuring medical malpractice (1991); randall r. bovbjerg, malpractice crisis and reform, 32(1) cunics in perinatology 203 (2005) [hereinafter cunics]. 11. e.g., m.a. hofmann, med mallnsuranceline could be improving: study, bus. ins., june 09, 2005, http://www.businessinsurance.com/cgi-bin/news.pl?newsld=5746 (last visited apr. 24, 2006). 8 indiana health law review [vol. 3:1 whether this state of affairs constitutes a crisis is endlessly debatable, for crisis is a political label that lacks objective definition. this article is not the place for a full airing of the debate over the precise extent and causes of current difficulties.12 suffice it to say that both sides of the debate are partly right.13 with regard to insurance, a key point to remember is that the main cost of liability insurance is liability, and increased payouts are a key driver ofhigher rates. other costs like legal defense and reinsurance also play a role. prices are also affected by lower investment returns, much as changes in interest rates greatly affect monthly car payments. overall, insurance is subject to cycles of underpricing followed by a kind of corrective or catch up, as are all markets where participants make bets on future developments-from bull-to-bear stockmarket shifts to the business cycle as a whole. 14 all partisans recognize the existence of the cycle, and lawyers implausibly blame all insurance cost increases on the cycle, together with insurer misbehavior. cyclical swings seem especially wide in medical malpractice, plausibly because risks are very hard to predict (claims rates or size of payouts can shift markedly), claim size is very large, and claims resolution is slow. when insurers' assessments of liability risk shift, they have to revalue all the years of pending claims "in the pipeline," which greatly affects their available capital and ability to underwrite new coverage. whether claims or claims payouts are too high is not an insurance issue, per se. the proper level is a matter of social judgment about extent of injury and appropriateness e>f recompense. the major insurance issues are (1) whether liability insurance correctly prices the cost of defending and paying liability claims and (2) whether the industry will continue to accept legal risk, so that practitioners will be able to continue in practice. despite the periodic overand underpricing, there is no real evidence that over time prices are persistently too high or too low. the industry is quite competitive-some would say too competitive during soft markets when prices are shaved.15 ease of entry by insurers in response to high profit margins protects against overpricing, 16 and ease of exit in time brakes underpricing. further, the 12. for a longer discussion, see cunjcs, supra note 8. 13. see randall r. bovbjerg & robert a. berenson, myths and mindsets in medical malpractice, (urban inst. 2005) [hereinafter myths]. both sides exaggerate, occasionally to the point of distortion. exaggerations on the physician side seem most extreme about liability's impact on access to care and the cost of health coverage. considered below at notes 31-41 and accompanying text. lawyer greatly exaggerate the mis-pricing of insurance relative to costs, considered below at notes 62-67 and accompanying text. 14. here too, for fuller discussion see cunics, supra note 8, at 207-08 and sources cited therein. 15. rachel zimmerman & christopher oster, insurers' price wars contributed to doctors facing soaring costs: lawsuits alone didn't inflate malpractice premiums; reserves at st. paul distorted pricing picture in 1990s, wail. st. j., june 24,2002, at 1. 16. cunics, supra note 8, .at 208. indeed, strong competition seems to play a major role in creating the underwriting cycle, in soft markets driving prices below what in hindsight looks to have been the right price for actual costs, once the passage of time makes those clear. 2006] beyond tort reform: flxing real problems 9 insurance market is dominated by physician and hospital run carriers, which are not motivated to overcharge their owner-customers and also have a mechanism to return excess premiums to policyholders through dividends (as was common in the early 1990s ). a final protection against overpricing is that many providers are able to self-insure or use alternative risk mechanisms outside the conventional insurance market if the latter provides a poor value for them. to date, insurers have always been willing to underwrite ooverage, although the industry has restructured and does not accept the full extent of risk it once did. as of early 2006, insurance seems to be becoming more available-in response to higher prices· and tort reform in some states-and price increases seem to be moderating. · there are also lesser concerns about how well insurance performs. ott one hand, pricing methods may not optimally relate price to underlying risk because physician premiums are determined almost entirely by location, specialty, and types of procedures performed.17 actual liability experience does not much affect premiums. because malpractice ·claims are infrequent and the extent of payout highly variable, individual experience rating is unusual, although some companies use small surcharges or discounts.18 hospitals, in contrast, are generally either experience rated or directly bear their liability risks through self insurance.19 not dissimilarly, the number of physicians in each specialty in most states is too small to have multiple rating areas, so that rates are the same in higher-risk urban areas as in less litigious rural ones. contrariwise, it can be objected that malpractice risk is too narrowly focused. in particular, some specialties j.ike obstetrics and orthopedic surgery face high claims and pay high premiums because they are perceived to be in charge, even though hospitals and multiple other physicians collaborate on providing care, bill independently, and in sum account for a bigger share of health plan reimbursements.20 a fmal important observation to be made is that insurance crisis makes a bad rationale for changes in public policy. crises come and go, whereas the underlying problems of medicine and law remain. 21 17. sloan et al., supra note 7, at 132. 18. frank a. sloan, experience rating: does it make sense for medical malpractice insurance?, 80 am. econ. rev. papers 128, 128 (1990). 19. hospitals may also use a captive insurer to essentially self insure. 20. william m. sage, the forgotten third: liability insurance and the medical .mapracticecrisis,23(4)healtiiaff.l0,15-16(2004);seewilliamm. sage, understanding the first malpractice crisis of the 21st century, in healrnla whandbook 1 (alice gosfield ed., 2003). 21. moreover, courts may overturn tort reforms enacted to deal with crises as unconstitutional once the crisis is long past. the supreme court ofwisconsin remarked upon this in overturning that state's cap many years after passage, ferdon v. wisconsin patients compensation fund, 701 n.w .2d 440,468 (wis. 2005) (noting "a past crisis does not forever render a law valid"). 10 indiana health law review [vol. 3:1 b. medicine since the beginnings of systematic assessment, the quality of medical services has been found to be uneven. too much medical care comprises under-service, over-service, or the wrong service in a given set of circumstances. 22 medical outcomes have improved by a number of objective indicators, including extended life, reduced disability, and ability to ameliorate conditions once deemed untreatable. 23 yet reducing the worst outcomes, negligent or preventable injuries, seems an elusive goal. this is the finding of a number of large-scale studies of hospital records in different states from the mid-1970s through the mid-1990s. 24 comparisons across time are problematic because preventing injury is not like running the hurdles but rather like the pole vault-just when you are doing well by one standard, they raise the bar. smaller, often observational, studies of practitioner behavior also report high rates of error, as do public opinion surveys.25 dispute remains about the precise extent of problems and the trend over time, but not about the existence of a large number of preventable injuries. much more prevention should be possible, which is one lesson of the decade-old patient safety movement, discussed in more depth below. 26 lawyers often argue that a small share of doctors is responsible for most negligent injury, implying that if doctors would just police the incompetents among their ranks, problems of medical injury would disappear.27 it is true that physicians with multiple claims account for a disproportionate share of liability cases (most doctors have zero claims, even over lengthy time periods ).28 it is also true that a small share of cases account for most payouts (most claims get zero, and the distribution of dollars paid is heavily "skewed" 22. inst. of med., crossing die quaury chasm: a new heallh system for die 21st century 2-3 (2001). 23./d. 24. seeinst.ofmed.,comm.onquauryofheallhcarejnam., toerr.ishuman: bldo. a safer heal til svs. app. c (linda t. kohn et al. eds., 2000) (consisting of a twenty­ six page chart of numerous studies); see also t .a. brennan et al., incidence of adverse events and negligence in hospitalized patients, 324 new eng. j. med. 370 (1991); eric j. thomas et at., incidence and types of adverse events and negligent care in utah and colorado, 38 med. care. 261 (2000). 25. e.g., robert j. blendon et al., views of practicing physicians and the public on medical errors, 347 new eng. j. med. 1933, 1934-35 (2002) (notingtbat thirty-four percent of adults said they or a family member have experienced a preventable medical error). 26. see generally lucian l. leape etal., promoting patient safety by preventing medical error, 280 jama 1444, 1445 (1998)(foundingandarticulatingtheprinciplesofthenational patient safety foundation). this paper does not defend any particular estimate of the extent of preventable injury, merely tbat it is large. 27. see mvms, supra note 13 and sources cited therein. 28. bd. of registration jn med., c0mmonweal1h of mass., 2004 medical malpractice analysis, nov. 2004. http://www.massmedboard.org/public/pdf/ announcements!med_mal_2004.pdf(last visited apr. 24, 2006). 2006] beyond tort reform: fixing real problems 11 to the right, or high end of dollars per case}.29 however, neither small share is typical; most physicians are infrequently sued, and most payouts are smaller than the mega-verdicts that claim headlines.30 doctors blame several other problems in medicine on the pernicious influence of the legal system. one is that malpractice concerns are reducing access to care.31 that is, physicians may retire early, leave a high-risk location, or cease providing high-risk services or seeing high-risk patients in order to reduce increasinglyunaffordable premiums and to mitigate their risks of uninsured reputational damage, psychic costs, and verdicts that exceed the limits of insurance. similarly, hospitals may close their maternity units. 32 there are some indications of reduced services in high-risk locations and specialties,33 and some indications that caps on awards slightly increase the supply of physicians in a state,34 but there is no strong evidence of widespread reductions in patient access to services. 35 second, doctors have long said that they practice defensively, meaning not that they are especially careful like defensive drivers, but that they make decisions or take action mainly for their own legal benefit rather than for the patient's clinical benefit. 36 some of this is characterized as negative defensive medicine, that is, not doing ethically or clinically indicated things for legal reasons-like seeing charity patients or providing obstetrical care to high-risk patients. most commonly mentioned is positive defensive medicine-such as ordering extra tests, doing unneeded procedures, or adding layers of documentation, because those things are perceived to lower risk oflawsuit or 29. see swan et al., supra note 7. 30. see myths, supra note 13. 31. u.s. dep't of health & human serv., office of the assistant sec'y for plannjng&ev aluation, confronting the new health care crisis: improving health care quality and lowering costs by fixing our medical liability system (2002), http://aspe.hhs.gov/daltcp/reportsllitrefm.pdf(last visited apr. 24, 2006). 32. randall r. bovbjerg & anna bartow, the project on med. liab. in pa., under­ standing pa. 's med. malpractice crisis: facts about liab. ins., the legal sys., and health care in pa. (june 2003 ), http:/ /medliabilitypa.orglresearchlreport0603/understandingr.eport.pdf(last visited apr. 24, 2006). 33. robert a berenson etal., medical malpractice liability crisis meets markets: stress in unexpected places, ctr. for studying health sys. change, issue brief no. 68 (2003), http://www.hschange.com/content/605. 34. daniel p. kessler et al., impact of malpractice reforms on the supply of physician services, 293 jama 2618,2620-21 (1998); william e. encinosa et al., have state caps on malpractice awards increased the supply of physicians?, health aff., ws-250, (2005). 35. u.s. gen. accounting office, medical malpractice: impucations of rising premiumsonaccesstohealthcare 836 (2003), http://www.gao.gov/new.items/d03836.pdf (last visited apr. 24, 2006). 36. see dep't health, educ., & welfare, drew pub. nos. 73-88, 73-89, medical malpractice: report of the secretary's commissiononmedicalmalpractice(1973); john r. ball, the malpractice threat: a study of defensive medicine, 1971 duke l.j. 939 ( 1971 ); laurence r. tancredi & jerome a. barondess, the problem of defensive medicine, 200 (4344) sci. 879 (1978). 12 indiana health law review [vol. 3:1 facilitate defense if claims are brought 37 defensive feelings clearly exist and are strongly held. actual impacts on practice are quite unclear, however, as is the more important issue of how much that defensiveness can be reduced by tort reform or any other policy initiative. 38 most researchers have found only small effects. 39 third, physicians complain that malpractice fears diminish the important therapeutic element of doctor-patient trust, as customers are seen too much as potential plaintiffs rather than patients.40 a related concern has surfaced in recent years, that fear of legal reprisal makes physicians reluctant to discuss adverse outcomes with their patients, peers, or safety managers.41 these concerns are real, although unquantified. c. law (i.e., tort liability) tort law theory is logical:42 liability process is to compensate negligent injuries, so as to deter potential tortfeasors from negligent behavior and thereby prevent injury, while providing justice to litigants.43 if liability achieved all these goals, it would easily be worth its share of health spending, just over two percent.44 but the theory has many practical weaknesses and evidence is sparse.45 37. 0ff1ce of tech. assessment, ota-h-602, defensive medicine and medical malpractice (1994) [hereinafter office of tech. assessment), ht1p://www.wws.princeton.edu/ota/diskl/1994/9405_n.html (last visited apr. 24, 2006). 38. see office of tech. assessment, supra note 3 7; myths, supra note 13. 39. the highest estimate is a net savings of about four percent, although only one pair of researchers have found such a sizeable amount 40. mark a. hall, law, medicine and trust, 55 stan.l.r.ev. 463,486(2002);michelle m. mello et al., caring for patients in a malpractice crisis: physicitm satisfaction and quality of care, 23(4) healthaff. 42 (2004). 41. randall r. bovbjerg. patient safety and physicitm silence, 25 j. legal med. 505, 511 (2004). 42. this subsection draws heavily upon randall r. bovbjerg & laurence r. tancredi, liability reform should make patients safer: ''avoidable classes of events" are a key improvement, 33 j.l. med & ethlcs 478, 480 (2005). 43. randall r. bovbjerg, medical malpractice on trial: quality of care is the important standard, 49 law & contemp. probs. 321, 326 (1986). 44. this is an imprecise estimate. in 2003, the best estimate is that premiums for malpractice were $14.8 billion for physicians and $6 billion for hospitals (including retained risk in lieu of premium), compared with total national spending on physician and hospital services of$369. 7 billion and $515.9 billion. the percentages are thus about 4% for physicians and 1.2% for hospitals, or a combined 2.3%. see u.s. tort costs: 2004 update, available at bt1p://www.towersperrin.com/tillinghast/publicationslreports/tort_2004/tort.pdf(last visited apr. 24, 2006); ctrs. for medicare and medicaid servs., source of funds and type of expenditure: 1998-2003, available at ht1p:/lwww.cms.hhs.gov/statisticslnhe/ (last visited apr. 24,2006). . 45. clark c. havighurst & lawrence r. tancredi, "medica/adversity insurance" -a no­ fault approach to medical malpractice and quality assurance, 51 miibankmem'lfundq., 125, 158 (1973); randall r. bovbjerg, medical malpractice: folldore, facts, and !l!e future, 2006] beyond tor.t reform: foong real problems 13 compensation falls far short of jurisprudential aspirations. few injured patients sue and fewer collect, payouts are slow and somewhat erratic, and overhead costs take well over half of each dollar. dete"ence is at best piecemeal. 46 the system is unsystematic because it reviews so few cases, standards of fault and causality are vague and often inconsistent, experts routinely disagree, results are unpredictable, and deterrence signals are confounded by liability msurance. there are no strong indications that medicine is safer or of higher quality where tort law is most stringent (or least tort reformed). clinicians see liability as arbitrary and unfair, not authoritative, and so tend to respond defensively rather than constructively. there are occasional exceptions; advances in anesthesia since the mid-1980s were triggered by high liability; the profession responded as a whole, not as individual defendants. finally, the weakest points in the argument for deterrence are that high rates of preventable error and injury persist,47 notwithstanding many years of intensifying legal exposures, and that quality of care varies markedly from place to place with no known relation to liability pressures. justice is offered in the form of individual procedural fairiless for litigants-that is, full opportunity to make their best case-and individual disputes are resolved better than physicians typically appreciate.48 but system justice is poor: the legal process omits most injuries, resolves disputes slowly and somewhat haphazardly, and pays out hugely variable amounts in similar cases-hardly attributes of a fair injury-resolution system. 49 indeed, liability is less a system than a set of processes and a framework for peaceful resolution of disputes. some litigants have been found to be satisfied, 5° but others are very critical ofthe legal process. 51 · these deep-seated, severe and ongoing problems with tort are much stronger policy grounds for reform than are periodic and impermanent liability insurance crises. 117 annals of internal med. 788, 789 (1 992); david m. studdert, michelle m. mello, & troyen a. brennan, medical malpractice, 350 new eng. j. med. 283, 289 (2004). 46. micbellem.mello&troyena.brennan,deterrenceofmedicale1tors: theoryand evidence for malpractice reform, 80 tex. l. rev. 1595, 1603-06 (2002). there is weak and conflicting evidence that automobile tort liability may make driving safer, but none for medical care. see discussion in randall r. bovbjerg & frank a. sloan, no fault for medical injury: theory and evidence, 61 u. cjn. l. rev. 53, 73-79 (1998). 47. see infra part id.b. 48. see, e.g., tom baker, reconsidering the harvard medical practice study: conclusions about the validity of medical malpractice claims, 33 j. l. med. ennes 501, 507 (2005). 49. randall r. bovbjerg & brian raymond, patient sqfety, just compensation and medical liability reform, http://www.kpihp.org/publications/docslpatient_safety.pdf (last visited apr. 24, 2006); medical malpractice, supra note 43, at 290. 50. sloan et al., ~upra note 7, at 5. 51. see, e.g., gibson & singh, supra note 6, at 213 (quoting anonymous patient family members). 14 indiana heal1h law review [vol. 3:1 to be fair, part of the problem with tort's fault-finding system is the imprecision of medical fault as a standard. unlike such problems as low birth­ weight or death under anesthesia, for example, negligent behavior, medical error, and medical injury are not objective occurrences but rather subjective conclusions from some process. reviewers largely apply implicit standards of care, whether through root-cause. analysis, peer review, research panel, licensure hearing, or jury trial. 52 making judgments is a timeand resource­ intensive process, and reasonable people very often disagree. 53 there appears to be substantial hindsight bias, and judgments about negligence tend to be influenced by how severe an ensuing injury turned out to. be. 54 this subjectivity is a significant problem for tracking.trends over time, drawing comparisons across institutions, determining best practices, and monitoring for enforcement rather than learning. a highly desirable reform would be to make standards more objective. ss ill. solutions for insurance, medicine, and law a. improvements for insurance policy makers have had to respond to upheavals in malpractice insurance since the mid-1970s. the most common fix for availability problems has long been for the state to form a ·~oint underwriting association" (jua) of existing insurers to offer coverage to those unable to find it in the open market. 56 juas charge above-market rates, seldom account for a large market share, and usually but not ilways tend to wither away as market conditions improve. another approach has been to create a publicly overseen "patient compensation fund" (pcf) to supply high-level coverage above the 52. see bovbjerg, patient safety and physicitm silence, supra note 41. 53. a. russell localio et al.,identifyinga.dverse events caused by medical care: degree ofphysicltm agreement in a retrospective chart review, 125 annalsofinternalmed. 457, 464 (1996); eric j. thojilbs et al., the reliability of medical record review for estimating adverse event rates, 136 annalsofinternalmedicine 812 (2002} erratum at 137 (2002): 147. 54. see robert a caplan, karen l. posner, & fmderick w. cheney, effect of outcome on physician judgments of appropriateness ofcare, 265 jama 1957 (1991); amy bradfield & gary l. wells, not the same old hindsight bias: outcome information distorts a broad range of retrospective judgments, 33 memory & cognition 120 (2005); thomas b hugh & g douglas tracy, hindsight bias in medicolegal expert reports, 176 med. j. of ausn.. 277, 278 (2002). 55. see saul n. weingart & usa l lezzoni, lookingfor medical injuries where the light is bright, 290 jama 1917, 1919 (2003)( concluding "developing and validating a robust set of measurement tools is essential to move patient safety information out of the shadows and into the lightj. 56. see randall r. bovbjerg,legislationon medictij malpractice: further developments and a preliminary report card, 22 u.s. davis l rev. 499 (1989) reprinted in 3 nat'l.ins. l. rev. 217 (1989). 2006] beyond tort reform: fixing real problems 15 primary coverage routinely purchased by providers, often as part of limiting payouts to the maximum available from the fund. a number of pcfs were begun in the 1980s, and some never operated or closed down. pennsylvania's fund undercharged physicians for its coverage, and its deficits had become a major problem in their own right by 2000,57 but performance in other states has pleased stakeholders. 58 a more recent approach to affordability problems is simply to subsidize physicians,s9 which has a certain appeal as a temporary, counter-cyclical intervention; in the longer run, it seems somewhat question­ able to ask taxpayers of all incomes to subsidize largely higher income physicians. can the wide swings of the insurance cycle be moderated? conceptually, it would seem that reforms could be helpful by making liability risk more predictable and claims resolution faster. this would greatly ease insurers' difficulties of prediction and keep more insurers in the liability market. caps on awards would serve to increase predictability by lopping off the high end of many recoveries. some suggest that caps helped maintain insurance availability in the 2000s, but strong evidence is lacking. 60 what caps do accomplish is to reduce claims rates and payouts-and thereby premiums, probably by about a third, other things equal.61 caps thus work as intended, that is, they reduce the amount of money moving from defendants and their 57. bovbjerg & bartow, supra note 32. 58. frank a. sloan et al., public medical malpractice insurance: an analysis of state­ operated patient compensation funds, 54 depaull. rev. 247, 254 (2005). 59. new jersey, for example, runs a medical malpractice liability insurance premium assistance fund. see new jersey dep't of banking and ins., questions and answers on the mmlipa fund, http://www.njdobi.org/mmlipafund.htm (last visited apr. 24, 2006). some hospitals have also sought to subsidize premiums for physicians important to the functioning of the hospital, which can be possible without running afoul of anti-kickback strictures. john w. jones, implications of malpractice insurance subsidies, physician's news digest, july 2005, available at http://www.physiciansnews.com/law/705jones.html (last visited apr. 24, 2006); see also ig says medical center can subsidize malpractice premiums for obstetricians, 8(18) health care fraud report, http://healthcenter.bna.com/pic2/hc.nsf/id/bnap· 64ujpg?opendocument (last visited apr. 24, 2006). 60. the ama's initial july 2002 list of twelve crisis states included only one state with a cap on awards, west virginia, which had an ineffective cap of$ i million. provider news malpractice: premiums reach 'crisis' levels in 12 states, am. heal'ihline, june 18,2002, http://www.americanhealthline.com. the crisis list was expanded by six additional states in march 2003, again, only one with any form of cap, missouri, which applies caps per defendant not per incident. e.g., new ama analysis shows 18 states now in full-blown medical liability crisis, am. med. news, mar. 3, 2003. the ama's 2005 report lists twenty states in crisis and no longer includes texas which is said to be recovering because of effective reforms including a cap. am. med. ass'n, medical liability crisis map, mar. 2005, http://www.ama­ assn.org/amalnoindex/category/ll87l.html (last visited apr. 24, 2006). 61. e.g., congressional budget office, limiting tort liability for medical malpractice, http://www .cbo.gov/ftpdocs/49xxldoc496810 1-08-medicalmalpractice.pdf(last visited apr. 24, 2006). congressional budget office. the effects of tort reform: evidencefromthestates,http://www.cbo.gov/ftpdocs/55xxldoc5549/report.pdf(lastvisited apr. 24, 2006). 16 indiana health law review [vol. 3:1 insurers to claimants and their lawyers. lawyers assert that caps do not work, but they are wrong. 62 many trial lawyers and some consumer groups assert that strong regulation is needed to rein in a profiteering insurance industry that exploits its customers.63 this solution has several problems. first, while one can readily expect insurance regulators to resist rapid rises in prices during a hard market, it is difficult to imagine elected or · politically appointed commissioners reliably denying price decreases when times are good. second, regulatory resistance to price increases may actually exacerbate the insurance cycle (and the need for higher prices) by driving insurers out of the market. 64 it has often been suggested that physicians should be insured along with the hospitals in which they practice. first promoted as a way to stabilize insurance availability and pricing by giving it a larger economic base,65 joint insurance became a part of broader proposals for enterprise liability in which not only risk bearing but also legal responsibility, defense, and risk management would be conjoined.66 joint insurance appears to occur today mainly within academic medical centers and affiliated institutions, where hospitals and physicians have a natural community of interest. further voluntary spread of the practice seems unlikely given current market trends away from closer integration between doctors and hospitals. some hospitals in the current crisis have sought to subsidize premiums, but not to merge risk sharing.67 b. improvements for medicine two approaches seem noteworthy. first, the most promising difference between today's malpractice crisis and earlier ones is that a new approach to 62. attorneys have argued that caps do not work because they disadvantage seriously injured patients. this is quite true. but more often, lawyers argue that caps fail to affect premiums-implying that insurers must continuously make excess profits. such a worldview is inconsistent with observed insurer behavior. 63. see ass'n of trial lawyers of america, supra note 2. 64. this was the conclusion of a classic study of the 1970s crisis. patricia m. danzon, the medical malpractice insurance crisis revisited: causes and solutions (hoover inst. duplicated, no. e-83-11 ); see also danzon, mamcalmalpractice: theorv,evidence,and pubuc poucy, supra note 8; sloan et al., supra note 7. 65. myron f. steves, jr., a proposal to improve the cost to benefit relationships in the medical professional liability insurance system, 1975 duke l. j. 1305, 1324-31 (1975) (explaining programs of joint insurance are sometimes termed channeling, evidently because separate physician liability risk is channeled into the same insurance program with hospitals). 66. e.g., kenneth s. abraham & paul c. weiler, enterprise medical liability and the evolution of the american health care system, 108 harvard l. rev. 381 (1994). for a current discussion, see randall r. bovbjerg & robert a. berenson, enterprise liability in the 21st century, in medicalmalpracticeandtheu.s. health care system: new century, different issues 219 {william m. sage & rogan kersh eds., 2006). 67. see jones, supra note 59. 2006] beyond tort reform: fixing real problems 17 medical injury has emerg~ one that directly addresses processes that underlie injuries. this is the patient safety movement, 68 which seeks to fix problems rather than blame by adapting systems approaches from industrial quality improvement and catastrophic accident avoidance. 69 safety analysts believe that most mistakes occur because people are human, not because they are incompetent or insufficiently penalized for mistakes. indeed, they have found · that blaming individuals seldom fixes problems; what is needed is simpler, more robust systems within which people work, along with processes for learning from accidents in order tore-engineer the administrative and clinical processes underlying the care provided. such approaches have had striking successes in reducing accidents in airplanes and factories, and there are promising indications that safety innovations can work in hospitals and other medical settings as well. promoting patient safety ought to have high social priority. public policy can promote safety in many ways, including provision of funds for research and demonstrations, promoting information transfer, modification of public health plans' payment methods, and pioneering ideas in federal health systems like the v cterans agency system. what relationship is there with liabilityrefonn? safety analysts say that fear of liability inhibits sharing of information and thus the learning that would result from assessing problems. but conventional tort refonn is not known to encourage patient safety initiatives nor to improve clinical outcomes. the top legislative priorities for safety reformers are to further curb the reach of conventional liability by keeping safety reports and analyses confidential, shielded from discovery in litigation, and by barring any use of provider apologies in litigation. 70 a better, fairer, and more effective approach would seem to be to combine safety improvement with just compensation, as . detailed below. this seems especially important given that an unintended side effect of patient safety successes and publicity has been to convince the public 68. see leape et al., supra note 26. 69. seegenerallysymposium,reducingerror,lnqjrovingsqfety,320brit.med.j. 725 (2000), http://www.bmj.bmjjournals.com(jast visited may 10, 2006). see also inst. ofmed., to err is human: building a safer healm system (linda t. kohn et al. eels., 2000), http://www.nap.edulbooks/0309068371/html/ (last visited apr. 24; 2006); robert m. wachter & kaveh g. shojania, internal bleeding: the truth behind america's terrifying epidemic of medical mistakes (2004). 70. on shielding safety data, see patient safety: instilling hospitals with a culture of continuous improvement, before the senate comm. on govt. aft, june 11, 2003, (testimony of dennis o'leary, pres. of joint comm. on accreditation of healthcare organizations), http:/lhsgac.senate.gov/_files/0611 03oleary.pdf(jast visited apr. 24, 2006). see patient safety and quality improvementact. h.r. 663, (108th congr.), 720 (2003) s. r. 196; h. r.128; see states with apology laws, http://www.sonyworks.net/ media25.phtml (last visited apr. 24, 2006); thomas h. gallagher, m.d., content of medical error disclosures, am. med. ass'n (2004), http://www.ama~assn.orglamalpub/category/12053.html (last visited apr. 24, 2006). 18 indiana health law review [vol. 3:1 that too much medical error exists and that practitioners ought to be held more accountable through lawsuits and discipline. 71 second, state medical boards' discipline of providers should be improved. observers have long agreed that ·some proportion of doctors practice beyond their competence, and that such problem physicians need to be dealt with. 72 this is the traditional role of the state medical board, the only entity with the ability to bar a doctor from practicing medicine or to restrict a physician's scope of practice across institutional settings. unfortunately, traditional methods of discipline often fail to reach many problem doctors. also unfortunately, constructive suggestions for improvement are rare. many simply assert that physician-dominated medical discipline puts the foxes in charge of the chicken coop. 73 not only is this metaphor wrong on its face-­ what the foxes oversee is the fox hunt74-but, worse, the popular policy conclusion is also inapt: it is not enough simply to empanel some non-foxes, as so many licensure reforms have done over the past twenty years. 75 the key issues are how to improve boards' complaint-driven traditional disciplinary processes, for example· with more resources, what new methods like re­ education to try in lieu of discipline, and whether society can rely more on other entities or methodologies, such as specialty societies' testing of practi­ tioners' continuing competence; much more work remains to be done here. improving upon boards' traditional, complaint-driven disciplinary processes is an area where most doctors and lawyers ought to be able to agree. attorneys are already vehement about the need for more vigorous discipline, although they exaggerate the extent to which truly incompetent providers account for most errors or medical injuries, as already noted. safety theorists should also recognize that despite the value of a blame :ftee.culture of safety for most practitioners,.some practitioners simply are unwilling or unable to 71. robert j. bh:ndon et al., views of practicing physicians and the public on medical errors, 347 new eng. j. med. 1933, 1938 (2002); thomas h. gallagher et al., patients' and physicians' attitudes regarding the disclosure of medical errors, 289 jama 1001, 1006 (2003). 72. r. c. derbyshire, what should the profession do about the incompetent physician?, 194 jama 1287, 1287 (1965). . 73. stanley j. gross, of foxes and hen houses: licensing and the health professions(1984); yann h.h. van geertruyden, comment, thefoxguarding the henhouse: how the health care quality improvement act of 1986 and state peer review protection statutes have helped protect bad faith peer review in the medical community, 18 j. contemp. health l. & pol'y. 239, 243-44 (2001). 74. the traditional metaphor more aptly applies to the tradition of letting physicians decide what medical care is needed, at what price. cf. j. m. eisenberg & s. v. williams. cost containment and changing physicidns 'practice behavior. can the fox learn to guard the chicken coop?, 246 jama 2195 (1981). 75. andis robeznieks, public active on medical boards, but not always tougher on doctors: having nonphysicians on state medical boards, however, is seen as a credibility. builder for panels seeking more public trust, americanm8dicalnews, nov. 11,2003. 2006] beyond tort reform: foong real problems 19 cooperate in developing and following new safety norms. for such practi­ tioners, there seems little alternative to state medical board intervention. 76 c. improvements for law two comments about improving legal performance should have highest priority, one negative and one positive. first, conventional tort reforms like caps on awards, more stringent statutes of limitation, ·and limits on lawyers' fees are the standard medical prescription for legal ills. 77 they are just what the doctor ordered, because as noted above, reforms generally improve the liability experience of physicians. 78 conventional reforms may also make liability risk somewhat more insurable, 79 and surely a cap on awards must ease medical providers' fear ofbankruptcy .from a huge verdict that far exceeds the limits of liability coverage. it is possible that tort reform slightly reduces provider defensiveness and keeps a small share of providers more accessible to patients. 80 however, tort reform directly hurts injured patients who litigate-a tiny minority-and does very little to help injured patients with legitimate claims who do not sue-the majority. most important is the impact on all patients, pre-injury. patients are the ones meant to benefit from tort law's prevention of injury, and they·(as patients and as taxpayers) ultimately pay for both medicine and its liability system. alas, while there is little enough evidence that liability itself makes patients safer, there seems to be no evidence that tort reform improves safety or even makes doctors more willing to embrace patient-safety methods or improvements. one reason must be that conventional liability reform leaves conventional legal process in place-just about a third less of it. historically, doctors have been complaining about deleterious impacts of liability on their 76. one quite intriguing idea of"institutionalliceosure" was suggested in an era before national malpractice concerns. see nathan hershey, an alternative to mandatory licensure of health professionals, so hosp. progress 17, mar. 3, 1969, http://www.ncbi.nlm.nih.gov (last visited apr. 24, 2006). the state would license only hospitals. relying on hospitals to oversee those practicing under their aegis. while conceptually appealing for an era when most consequential medicine occurred within hospital walls. the idea (i) bas always lacked political "traction" given how jealously professions guard their traditional prerogatives and (ii) fits much less wen for current and emerging patterns of practice in which hospital play a lesser roles, as noted about institutional liability above. 77. randall r. bovbjerg. medical malpractice! folklore, facts, and the future, 117 annals of internalmed. 788, 789-790 (1992); eleanor d. kinney, malpractice reform in the 1990s: post disappointments, future success?, 20 j. heal1h pol. pol'y & l. 99, 101 (1995). 78. see cb0 reports. supra note 68. 79. see clinics, supra note 8. 80. e.g., encinosa et al., supra note 34. 20 indiana heal til law review [vol. 3:1 practices for over thirty years, starting in eras when liability was far smaller than now achievable by the strongest current tort reform. 81 today, even in california, which has physicians' ideal package of tort reforms, physicians note continuing problems of defensiveness and erosion of trust.82 it would be good to do better. first, it would be good if liability signals could be made more credible to physicians, who are the main people that liability is meant to influence. second, there ought to be more even-handed tort reform. conventional tort reforms all seek to favor defendants at the expense of plaintiffs. even­ handed reform would seek to improve the process rather than the prospects of either side. law should just work better, that is, faster, at lower overhead cost, and with results that are more predictable and consistent across cases. one area ripe · for improvement is the use of expert witnesses. perceptions that experts are for hire feed medical mistrust of the judicial process and the accuracy of its liability signals. these perceptions likely undercut whatever useful deterrent law might provide. the conventional response has heen to make it more difficult to quality outside experts to testify on local standards of care and to seek sanctions against experts perceived to provide partisan rather than objective testimony. 83. why is there no effort to promote availability of good witnesses? why cannot ways be found to reduce partisanship in shopping for experts? why can the law not do more to rely upon scientific medical evidence rather than individual testimony of experts?84 reform might address the unpredictability of damage awards that can impede prompt settlement, raise costs of disputation, and lead to disparate results in similar cases. proposals to reduce the wide variations in legal treatment of non-pecuniary losses are a good example. they could improve proportionality and consistency ofresults,85 but have never advanced far in policymaking because they lack political support. doctors prefer unfair, flat 81. defensiveness and loss of trust were centerpieces of the first national hearings held on medical malpractice-in 1969. senatesubcomm. onnutritionandhumanneeds, 91st cong., medicalmaipracllce: thepatientversus the physician (comm. print 1969). 82. myths, supra note 13, at 17. 83. michelleandrews,makingmalpracticehardertoprove,n.y.times,dec.21,2003, at8. 84. cf. charles m. clark & eleanor d. kinney, standards for the care of diabetes: origins, uses and implications for third-party payment, 15 diabetes care 10 (supp. 1992) (discussing the extant medical practice guidelines regarding the treatment of diabetes); todd feinman, malpractice: a different kind of tort reform, med. econs., aug. 5, 2005, http://www.memag.com/memaglarticle/articledetailjsp?id= 17291 o&&pageid=2. (last visited aprl24, 2006) ("this internist uses evidence-based medicine to help lawyers handle malpractice cases."). 85. proportionality means vertical equity-providing larger awards for larger injuries; consistency means horizontal equity-similar awards for similar injuries. traditional legal practice has few tools for achieving either form of equity. the reader is encouraged to use google to search <proportionality consistency fair equitable> and observe how many enforcement processes aspire to these standards ..• but not the u.s. personal injury system. 2006] beyond tort reform: foong real problems 21 caps on awards, and lawyers resist any change in the open-ended traditional system for assessing the severity of injury and value of loss. 86 another area that seems overdue for practical rather than ideological improvement is judicial administration. how is it that cases involving medical injuries take twice as long to resolve in the slowest states compared to the fastest?87 a start in the right direction would be to maintain much better data on lawsuits and their resolution and to support much more management­ relevant analysis. 88 these comments merely scratch the surface. a great deal more could be done here to develop a better, more balanced tort reform agenda. iv. combining patient safety and legal reform this paper contends that the best reform would seek to promote both patient safety and better legal compensation for injury. tort law is so attractive to many thinkers in part because it purports to deter by compen­ sating, and reforms that can both deter and compensate are highly desirable. safety advocates have generally shied away from such an approach. 89 in a more ideal world, caregivers would tell patients and families whenever medical errors or overreaching occur. reasonable compensation would follow for those with preventable injuries. patient-safety management would thus learn of problems and be able to continuously improve the clinical and administrative processes that support high-quality, low-error provision of services. practitioners would worry more about patient outcomes than legal outcomes, and outside systems of accountability would make it easier, not harder, for caregivers and medical institutions to do the right thing.90 this section discusses several approaches that might move practice in this direction. 86. frederick s. levin, pain and s'4ffering guidelines.~ a cure for damages measurement"anomie,"22u.mich.j.l.reform303,303(1989);randallr.bovbjergetal., valuing life and limb in tort: scheduling"pain and s'4ffering," 83 nw. u. l. rev. 908,968 (1989). 87. the four fastest states in payouts of physician malpractice claims in 2003 had median delays between incident and payout oftbree years or less. the four slowest all took five and a half years or more. delays in average payouts are half a year to a full year longer in each state because a small share of very slow cases make the average longer than the typical case. delays for the five percent or so of cases litigated to trial are presumably much longer still. nat'l pracimoner data bank. 2003 annual report, table 13, http://www.npdb­ hipdb.com/pubs/stats/2003_npdb_annual_report.pdf(lastvisitedapr.24,2006). 88. randall r. bovbjerg & joel m. schumm, judicial policy and quantitative research: indiana'sstatuteoflimitationsfor medica/practitioners, 311nd.l.rev.l051, 1051 (1998). 89. for a fuller treatment of this line of reasoning, see bovbjerg & tancredi, supra note 42; see also bovbjerg & raymond, supra note 49. 90. see bovbjerg, patient sqfety and physician silence, supra note 41. 22 indiana health law review [vol. 3:1 a. enterprise responsibility holding enterprises responsible for patient injuries has appeal because patient safety calls for a systems approach, suggesting that legal responsibility should fall to a system-that is, an enterprise. success stories about advances in patient safety to date almost all come from hospitals and other organized systems.91 some of them organize hospitals and medical staffs·together to bear risk of litigation, defend claims, and manage risks and patient safety. thus, the rise of patient safety approaches seems to support dusting off the earlier theory that enterprises should have sole responsibility for legal liability, under the fault system or any replacement injury resolution system. this would require legislative reform of tort liability, but not to restrict plaintiffs' accustomed prerogatives, only the focus of responsibility. enterprise responsibility has several good features: it would allow institutions to create cultures of safety within themselves by sheltering individual caregivers from liability fears (at least the monetary aspects of liability), thus possibly encouraging more internal reporting of problems. larger institutional scale for insurance would assure a good price for liability coverage for whatever rate of claims and payouts the enterprise develops. conjoined responsibility would reduce finger pointing among defendants, which they would probably like, although plaintiffs' attorneys would not. finally, it would encourage collective, institution-wide monitoring and quality feedback and also allow attention to systems errors going beyond the individual that affect individual practice. enhanced institutional responsibility also bas a downside: it could lead to a deep pocket increase in claims and awards without regard to actual losses. it would make physicians more dependant on hospitals, which might reduce their sense of personal responsibility and willingness to help defend the enterprise. the collective incentive for joint defense could recreate the old­ time conspiracy of silence-the dark side of non-finger-pointing. practi­ tioners outside institutions would likely escape effective oversight from enterprises. overall, enterprise responsibility seems unlikely to promote greater compensation of injured patients.92 in practice, being able to move to enterprise liability presupposes the existence of effective medical enterprises, mainly hospitals that have common interests and coordinated organization with attending physicians. it is this type of integration that encourages physician involvement in patient safety interventions, yet medicine has retreated from a mid-1990s flirtation with more integrated forms of medical organization. outpatient and inpatient 91. see kobn et al., supra note 24; wachter & shojania, supra note 69. 92. randall r. bovbjerg, medical malpractice: problems & reforms: a policy--maker's guide to issues and information, in w ashjngton, dc: tim urban instmjte and tim intergovernmental heal1h poucy project (george washington univ. 1995), http://www.urban.orglurl.cfin?id=l000414 (last visited apr. 24, 2006). 2006] beyond tort reform: fixing real problems 23 practices are now more separated from each other. many traditionally inpatient procedures can be done on an outpatient basis, and many community practitioners are handing over inpatient care of their patients to hospitalists. moreover, hospitals also control less of the healthcare dollar, as spending has shifted in the direction of pharmaceuticals and other non-hospital therapy. joint responsibility of physicians and their hospitals makes good sense where they are voluntarily organized to act jointly, but attempting to force them together by liability reform seems problematic.93 those enterprises that have integrated, however, would be good locations for experimentation with patient safety-oriented liability reform. b. enhanced disclosure plus patient safety a second approach could also occurundertoday's liability system. that is, for potential defendants (hospitals and physicians) to openly disclose medical injuries to patients and their families-a reversal of the traditional legal advice never to discuss such problems. the goals of enhanced dis­ closure are to speed compensation and improve patient relations, reduce litigi­ ousness, and encourage better patient safety and provider cooperation in dis­ closure of and learning from problems.94 given that safety analysis starts with disclosure of problems, better disclosure will plausibly be helpful for safety. if caregivers fully disclose errors and also offer recompense, this approach would reform compensation as well. 95 but disclosure need not involve accepting responsibility, including for monetary losses, and many providers remain concerned that disclosure will simply facilitate lawsuits.96 only one published study, from a veterans affairs (va) hospital, supports the belief that patients treated right will be less vengeful and more willing to settle for a relatively low dollar figures.97 some additional, unpublished accounts corroborate the va hospital's experience, notably at the university of michigan.98 where injuries are very costly, as in many newborn cases, large settlements seem likely to be needed, yet even for them, disclosure-enhanced trust could facilitate a reduction in costs of prolonged disputation.99 93. for a full discussion see myths, supra note 13. 94. nat'l patient safety found., talking to patients about health care injury: statement ofprinciple (oct. 2005), http://www.npsf.org/html/statement.html (last visited apr. 24, 2006). 95. it is quite possible to disclose a medical problem without taking responsibility for it. much of the discussion of apologies at least implies that this is the advisable course of action for physicians to follow. 96. see bovbjerg, patient safety and physician silence, supra note 41. 97; see steves. kraman & ginny hamm, risk management: extreme honesty may be the best policy, 131 ann. intern. med., 963, 963 (1999). 98. see the sorry works! coalition, http://www.sorryworks.net (last visited june 12, 2006). 99. precisely to deal with very expensive cases, one long~time reform proposal would allow defendants to avoid any liability recovery for pain and suffering if they promptly offer an injured patient complete compensation of the patient's ongoing out-of-pocket injury costs as 24 indiana health law review [vol. 3:1 the largest boost to disclosure has come from the rules of the joint commission on accreditation ofhealthcare organizations (jcaho) that call for hospitals to adopt disclosure policies as well as to investigate significant errors or injuries dubbed "sentinel events."100 if such hospital-led disclosure becomes common, it seems likely to bring physicians and hospitals together, perhaps facilitating a more enterprise-based approach in the future. c. alternative non-tort system i: administrative compensation this alternative would in many ways resemble workers compensation. virginia and florida have run such non-tort compensation systems with some success for severely neurologically impaired newborns. private insurers or self-insured groups would bear risk and pay claims. disputes would be resolved by an expert administrative agency. lawsuits would be limited to very unusual circumstances, as would recoveries for damages.101 to maintain affordability of coverage, most proposals assume that the new injury coverage would be secondary to existing health insurance plans, disability coverage, and other payors. non-liability payors pay for most medical injuries today; maintaining this financing role is important for transitioning to a new medical injury system. over time, these. traditional payors and the new injury system would benefit from improved prevention of injury and faster remediation of injuries. most proponents of administrative compensation would replace fault with a standard of avoidability or preventability of injury. 102 this standard is easier to apply than fault, as reviewers more readily agree about which injuries are preventable than about which are negligent preventability would make more events eligible for compensation, and it would be more consistent with patient safety's focus on prevention. the pattern of claims resolutions would they are incurred (net of any other insurance coverage or public program). jeffi'ey o'connell, offers that can't be refused: foreclosure of personal injury claims by defendants' prompt tenderofciaimants • net economic losses, 77nw. u.l.rev. 589(1982);1. o'connell & p.b. bryan, more hippocrates, less hypocrisy: 'early offers • as a means of implementing the institute of medicine's recommendations on malpractice law, 15 j. l. health 23 (2000-0 1 ). 100. rae m. lamb et al., hospital disclosure practices: results of a national survey, 22(2) health aff. 73, 73 {2003); randall r bovbjerg, liability problems and transparent disclosure to patients as a solution, in final narrative report to the johnson foundation's program on changes in health care financing & organization (unpublished,2005),summarizedinmalpracticetortreform&safety,inchangesinhealth care financing & organization news & progress {washington, dc: academyhealth online newsletter, june 2005), http://www.hcfo.net/pdf/news0605.pdf. 101. see david m. studdert & troyen a. brennan, no-fault compensation for medical injuries: the prospect for error prevention, 286 jama 217 (2001 ); david m. stoddart & troyen a. brennan, toward a workable model of "no-fault" compensation for medical injury in the united states, 21 am. j. law med. 225 (2001 ). l 02. the approach has long been known as "no molt." studdert & brennan, supra note 101 at 219, which wrongly implies no accountability. supporters of administrative compensation say, to the contrary, that well-decided findings of preventability would more readily support remedial action and prevention of future problems. 2006] beyond tort reform: foong real problems 25 thus be more useful for safety improvement than are current tort outcomes. the system would remain claims-driven, however, formal adjudications would remain prominent, and administrative costs would still be significant. d. alternative non-tort system ii: avoidable events this approach would pay automatically for injuries listed in advance as avoidable events. 103 experts would develop these avoidable classes of events (aces) based upon epidemiological evidence and expert consensus. these ace listings would promote disclosure or discovery of worthy cases and encourage prompt resolution thereafter, with little need for formal adjudication, judicial or administrative. aces would also constitute much more objective indicators of problems than do liability outcomes, which should facilitate patient safety analysis and response. one existing analogue to aces is the list of compensable events used to resolve injuries related to administration of childhood vaccines, although that listing is not based on preventability of injury. 104 aces could probably cover most injuries, and payment rules could be standardized. disputes over ace status and non-ace injuries would be re­ solved through mediation and arbitration or some other agreed private process. ace listing takes the place of an adjudication of liability or responsibility; ace damage rules could also be standardized, as discussed above for administrative compensation. aces could be implemented as part of private reforms under which providers and patients or health plan enrollees would agree in advance to resolve injuries within the new system. alternatively, they could be used to make administrative compensation systems more efficient and consistent in operations. supporters of administrative compensation and of aces recognize that these approaches would constitute very large changes and that they would be based on relatively little experience to date. they accordingly tend to promote testing out actual implementation through demonstration projects, an approach supported by an institute of medicine committee and promoted by a current congressional bill. 105 demonstrators could be states, large integrated medical systems, or medicare. 106 103. a long line of scholarly articles bas developed this concept see bovbjerg & tancredi, supra note 42, reviews and updates ace research. 104. see health resources and services administration, u.s. dep't of health & human servs, national childhood vaccine injury act: vaccine injury table, bttp:/lwww.hrsa.gov/ vaccinecompensationltable.btm (last visited apr. 24, 2006). 105. the fair and reliable medical justice act., s. 1337, 109th cong. (2005); lnst. of med., liability: patient-centered and safety-focused, nonjudicial compensation, in fostering rapid aov ances in health care: learning from systems demonstrations (janet m. corrigan et al. eds, nat'l acad. press 2002), http://www.nap.edu/books/ 0309087074/html (last visited apr. 24, 2006). 106. inst. of med., supra note 105. the iom committee emphasized states. ace reformers have emphasized private contractual arrangements involving medical systems. e.g., 26 indiana health law review [vol. 3:1 v. concluding observations your commentator's career in health law and policy has been enlivened by the opportunity to witness and write about tbree national upheavals in medical liability insurance since the mid-1970s. 107 early on, almost all policy­ relevant information came from interested parties. 108 over time, a very encouraging development has been substantial growth in knowledge about malpractice.109 even more encouraging has been the rise of patient safety methods as a preventive alternative to the retrospective blame-finding of conventional litigation. however, a discouraging note is that that the centerpiece oftoday's national debate about malpractice is federalization of the same state tort reforms that were first enacted in california in 1975. very similar points are still being made for and against these reforms-albeit with more factoids used by both sides-despite the passage of thirty years. the likelihood seems high that the opportunity will come to comment on another malpractice crisis in the foreseeable future. one can only hope that before then some farsighted actors will have shown how uvury compensation and deterrence can work better, whether using ideas noted in this essay or developing better ideas of their own. if such encouraging developments do occur, then the fourth national upheaval may be less threatening to providers and patients alike, and public policymak:ers will have improved new models of response that go beyond the 1970s' invention of conventional tort reforms. bovbjerg & tancredi. supra note 42. medicare oriented reform is promoted by william sage &eleanorkinney,metlicore-ledmalpracticereform,inmei>icalmalpra.cnceandtiieu.s. health care system (sage & kersh eels., cambridge univ. press forthcoming). 107. e.g., randall bovbjerg, the medical malpractice standard of care: hmos and customary practice, 1975 duke l. j. 1375 (1975); randall r. bovbjerg, medical malpractice on trial: quality of care is the important standard, 49 law and contemp. probs. 321 (1986); cijnics, supra note 8. 108. thefirstsignificantetfortwastbeseclmtary'scommisslonreport,supranote36. most subsequent work was not federally funded. 109. compare stephen zuckerman et al., information on malpractice: a review of empirical research on major policy issues, 49 law and contemp. probs. 85 (1986) (complaining of dearth of good studies) with bovbjerg, policy-maker's guide, supra note 92 (precis of relevant knowledge). duty -to-warn-even if it may be hearsay? the implications of a psychotherapist's duty -to­ warn a third person when information is obtained from someone other than his patient deborah c. edwards· i. introduction on june 21, 2001, geno colello, a former member of the los angeles police department, had dinner with his parents. he was depressed and he told his father, victor colello, that he "hurt inside, and [did not] want to live anymore."1 he asked his dad to give him a gun because he wanted to commit suicide. his father refused. geno said that instead of just killing himself, he was going to get a gun and "kill [the] kid"2 that was romantically involved with his ex-girlfriend, and then kill himself. his father told him to '"buckle up' and not 'take the coward's way out. "'3 geno punched his father in the face and asked his father to take him to the hospital. victor contacted geno' s therapist, dr. david goldstein, whom geno had been seeing for "work-related emotional problems and problems concerning his former girlfriend, diana williams. •>4 victor told dr. goldstein what geno said, and dr. goldstein"urged [victor] to take [geno] to northridge hospital medical center, where goldstein arranged for him to receive psychiatric care."5 art capilla, a licensed clinical social worker, met with geno and his father when they arrived at the hospital. capilla denied ever being told about geno's threats. "capilla asked [geno] if he 'intended to kill ... the new boyfriend.' the record does not reflect [geno's] response.''l6 later that day, geno was voluntarily hospitalized. he was discharged on june 22, 2001 because he was found by a staff psychologist not to be suicidal, and the next day geno murdered williams' new boyfriend, keith ewing, and then committed suicide. * j.d. candidate, 2006, indiana university school oflaw-indianapolis; b.s. business management, 2001, indiana university-kelley school ofbusiness, indianapolis, indiana. i would like to thank erin drummy abraham for her help and insight most importantly, i would like to thank leiann dobbins and my son, jonathan edwards, for their understanding and support during the long hours spent researching and writing this note. 2004). l. ewing v. northridge hosp. med. ctr., 16 cal. rptr. 3d 591, 593-94 (cal. ct. app. 2. /d. 3./d. 4. ewing v. goldstein, 15 cal. rptr. 3d, 864,866 (cal. ct. app. 2004). 5. id at 867. 6. northridge hosp., 16 cal. rptr. 3d at 594. 172 indiana health law review [vol. 3:171 keith's parents sued dr. goldstein and northridge hospital.7 the ewings alleged that dr. goldstein as well as capilla ''failed to discharge [their] duty to warn [keith] or a law enforcement agency of the risk of harm" because geno "posed a foreseeable danger to their son, and had directly or indirectly through third persons communicated to goldstein [and capilla] his intention to kill or cause serious physical harm to [keith]. "8 the trial court found for the hospital and dr. goldstein because "'the patient himself had not communicated the threat to the therapist. "9 in two separate rulings, the california court of appeals reversed the trial courts' rulings and, respectively, found dr. goldstein and northridge hospital · medical center responsible for the wrongful death of keith ewing.10 the northridge court stated that if a serious threat of "grave bodily injury'' is communicated to the psychotherapist by a member of the patient's immediate family and is shared for the purpose of facilitating and furthering the patient's treatment, the fact that the family member is not a patient of the psychotherapist is not material. 11 on november 10, 2004, the california supreme court denied both dr. goldstein's as well as northridge hospital medical center's petition for · review.12 therefore, the current law in the state of california, which may influence similar rulings in other jurisdictions, is that a psychotherapist has a duty-to-warn a third-person of any threat of serious bodily injury conveyed to the . psychotherapist, not only from communications between the psychotherapist and the patient, but between the psychotherapist and a member of the patient's "immediate family."13 7. the ewings sued dr. goldstein for wrongful death based on professional negligence, and they sued northridge hospital alleging the hospital was vicariously liable for the acts of its employee, art capilla. /d. 8. goldstein, 15 cal. rptr. 3d at 867. 9. northridge hosp., 16 cal. rptr. 3d at 593 (emphasis added). 10. goldstein, 15 cal. rptr. 3d at 864, 866; northridge hosp., 16 cal. rptr. 3d at 591, 593. 11. northridge hosp., 16 cal. rptr. 3d at 596 (emphasis added). 12. the supreme court of california did not publish an opinion on the reasons for denying review. however, justices baxter and brown were both of the opinion that the petition should have been granted, but the majority denied the petition for review. ewing v. goldstein, 2004 cal. lexis 11307 (cal. 2004); ewing v. northridge hosp. med. ctr., 2004 cal. lexis 11295 (cal. 2004). california appellate courts, case information, available at http:// appellatecases.courtinfo.ca.gov/searcb/dockets.cfin?dist=2&doc _ id= 162208&div=8 (last visited mar. 8, 2005); california appellate courts, case information, available at http://appellate cases.courtinfo.ca.gov/searchldockets.cfin?dist=o&doc _ id=338171 (last visited mar. 8, 2005). 13. since the ruling in both ewing decisions, the appellate courts' decisions have been recorded in publications to advise psychotherapists that the duty-to-warn may arise even if the danger is communicated from a patient's immediate family member. see 33 cal. forms of pleading and practice, annotated 14, ch. 380, pt. i; 26 cal. forms of pleading and practice, annotated 59, cb. 304, pt. n (stating that: although the statute states that the communication must come from the patient to trigger a duty to warn, the court of appeals bas held that the duty to warn is 2006] duty tow arn-even if it may be hearsay? 173 this article begins in part two with the general history of privileges and continues with the united states supreme court's creation of the psychotherapist-patient privilege in federal court with the court's decision in jaffee v. redmond.14 part three discusses the history of the psychotherapist's duty-to-warn a third party from information obtained during the confidential and privileged conversations with the patient. it begins with both holdings in tarasoffv. regents ofuniv. of cal. 15 and continues with the current status of the duty-to-warn in the sixth circuit and the ninth circuit followed by examples of a few of the state courts including texas, pennsylvania and delaware. part four explores the implications of both ewing decisions from the california court of appeals. the court held that a psychotherapist has a duty-to-warn a third party when the information was obtained from someone other than the patient. the duty-to-warn includes a situation where no psychotherapist-patient relationship exists between the information-provider and the psychotherapist. ii. history of the psychotherapist-patient privilege a. privileges in general evidentiary privileges exist in an effort to balance the social costs of obtaining all necessary information for full realization of justice with the benefits of protecting sacred and privileged relationships. 16 a privilege is granted in order to encourage communication between the parties protected by a particular privilege. the parties must strike a balance between maintaining the zones of privacy in a relationship and the right to defend oneself or prosecute claims in court by obtaining necessary evidence.17 courts have found that the social cost of protecting these relationships far outweighs the testimonial benefits. 18 communication privileges are generally held to the following conditions: also triggered under the statute if the threat of hann is communicated to the psychotherapist by a member of the patient's immediate family for the purpose of facilitating and furthering the patient's treatment. jd. (emphasis added)). 14. jaffee v. redmond, 518 u.s. 1 (1996). 15. tarasoffv. regents ofuniv. of cal., 529 p.2d 553,561 (cal. 1974) (tarasoff/); tarasoffv. regents ofuniv. of cal., 551 p.2d 334,340 (cal. 1976) (tarasoff/1). 16. such privileged relationships include the relationship between an attorney and client, physician and patient, husband and wife, and priest and parishioner. 17. christopher b. mueller & laird c. kirkpatrick, evidence under the rules 757 (5th ed. 2004) [hereinafter mueller]. 18. harvard law review ass'n, evidence-federal testimonial privilege-ninth circuit holds that there is no dangerous-person exception to the federal psychotherapist­ patient privilege-united states v. chase, 340 f.3d 978 (9th cir. 2003) (en bane), 117 ha.rv. l. rev. 996 (2004). 174 indiana healtii law review [vol. 3:171 (1) the privileged communications originate in confidence; (2) confidentiality is an essential element of the proper relationship between the parties; (3) the relationship is one that the community wishes to encourage; and (4) the injury caused by damaging the relationship through disclosure of the communications would be greater than the benefit gained.19 early english common law established that a privilege existed between an attorney and client, but it was not until 1828, ·in new york, that an attorney-client privilege was recognized in the unite(! states.20 a senate advisory committee drafted thirteen proposed rules governing privileges.21 controversy arose in congress regarding the scope and propriety of any privileges being promulgated under the rules enabling act.22 congress was mainly concerned "about the omission ofboth the physician-patient privilege and the marital communications privilege"23 and about "the fact that the rules as promulgated would have applied to all actions in federal courts, overriding state privilege law, even where state law supplied the rule of decision."24 congress responded by deleting the individual privilege provisions in the proposed rules and enacting the federal rule ofevidence 50 1.2s federal rule 19. kinsella v. kinsella, 696 a2d ss6, s6s-66 (n.j. 1997). 20. bruce gross, privileged communication (may/june annals 2002), available at http://michaelariens.com/evidencelacnl.htm#article%20v (last visited feb. 12, 2006). 21. while there were thirteen proposed rules governing privileges, the federal courts were required to recognize nine, which included: "required reports, lawyer-client, psychotherapist­ patient, husband-wife, communications to clergy, political vote, trade secrets, secrets of state and other official information, and identity of informer." michael ariens, legislative history to federal rules of evidence, available at http://www .micbaelariens.com/evidence/acnl.htm (last visited mar. 8, 2005). 22. the rules enabling act provides that: (a) the supreme court shall have the power to prescribe general rules of practice and procedure and rules of evidence for cases in the united states district courts (including proceedings before magistrate judges thereat) and courts of appeals. (b) such rules shall not abridge, enlarge or modify any substantive right. all laws in conflict with such rules shall be of no further force or effect after such rules have taken effect. (c) such rules may define when a ruling of a district court is final for the purposes of appeal under section 1291 of this title. rules enabling act; 28 usca § 2072 (2004). 23. mueller, supra note 17,at7s8. 24. id. 25. the federal rule of evidence sol states: except as otherwise required by the constitution of the united states or provided by acts of congress or in rules prescribed by the supreme court pursuant to statutory authority, the privilege of a witness, person, government, state, or ·political subdivision thereof shall be governed by the principles of the common law as they may be interpreted by the courts of the united states in the light of 2006) duty tow arn-even if rr may be hearsay? 175 of evidence 501 states that absent acts of congress or rules of the supreme court, privileges are "governed by the principles of the common law as they may be interpreted by the courts of the united states in the light of reason and experience."26 b. the psychotherapist-patient privilege 1. history of the psychotherapist-patient privilege the proposed rules that were submitted to congress in 1972 included the psychotherapist-patient privilege in proposed federal rule of evidence 504.27 "[i]nherent in a supreme court recommendation of the psycho­ therapist-patient privilege is the court's belief that confidentiality in psycho­ therapy would benefit both the patient and the public despite the evidentiary loss to society."28 although the proposed rules were rejected, 29 the senate judiciary committee stated that even though it was only approving a general rule, it was not disapproving the recognition of any other privilege including: psychiatrist-patient, or husband-wife, or any other of the enumerated privileges contained in the supreme court rules. rather, our action should be understood as reflecting the view that the recognition of a privilege based on a confidenreason and experience. however, in civil actions and proceedings, with respect to an element of a claim or defense as to which state law supplies the rule of decision, the privilege of a witness, person. government, state or political subdivision thereof shall be determined in accordance with state law. fed. r. evid. 501. 26. /d. 27. the general rule of privilege in the proposed federal rule ofevidence 504 was stated as follows: (b) general rule of privii..eoe. a patient has a privilege to refuse to disclose and to prevent any other person ftom disclosing confidential communications, made for the pwposes of diagnosis or treatment of his mental or emotional condition, including drug addiction, among himseu: his psychotherapist, or persons who are participating in the diagnosis or treatment under the direction of the psychotherapist, including members of the patient's fiunily. steven goode&: oun guy weu.born iii. courtroom evidence handbook 2004-2005 student edmon 135 (thomson/west 2004) (1995). {hereinafter evidence handbook]. 28. huston combs, note. dangerous patients: an exception to the federal psychotherapist-patient privilege, 91 ky. l.1. 457, 459-60 (2003). [hereinafter combs]. 29. the advisory committee eliminated all ofthe specific rules on privileges and adopted a single rule, rule 501, which left the law of privileges to current state and common law definitions. the committee rationalized that federal law should not supersede that of the states in areas such as privilege while also being concerned with forum shopping in some civil actions. legislative history to federal rules of evidence, at http://www.micbaelariens.com/evidence/ acnl.htm oast visited mar. 8, 2005). 176 indiana health law review [vol. 3:171 tial relationship and other privileges should be determined on a case-by-case basis. 30 long before · these proposed rules of evidence, the earliest psychotherapist-patient privilege case on record was decided on june 24, 1952, by the circuit court ofcookcounty, idinois in the case of binder v. ruvell. 31 the binder court stated that because a psychiatrist is a physician, the relationship between a psychiatrist and a patient is the same as that of a physician and a patient, which was already a recognized privileged relation­ ship. the binder court reasoned that a psychiatrist works with his patient to find the cause of mental and emotional problems in. the patient, and that his analysis must include all experiences of the patient while deeply probing the patient's thoughts and problems just to get patients to speak about their problems. 32 the court continued by stating that courts should "guard the secrets which come to the psychiatrist, "33 and a psychotherapist should not be allowed to disclose any of the secrets provided by the patient. the court concluded "it is just one of those cases [where] the (psychiatrist-patient] privilege ought to be granted and protected. and the social significance of it is probably even greater than that which comes from the protection of the communication between lawyer and client. "34 twenty-four years a~ binder, in may 1976, the fifth circuit was the first court to interpret the newly adopted federal rule of evidence 501. in united states v. meagher,35 the defendant argued that by allowing his psychotherapist to testify concerning their conversations, the court "violated his privilege, as a patient, against the disclosure of information confidential to a physician. "36 the court reasoned that rule 501 "states that unless otherwise provided, the privilege of a witness shall be governed by the principles of common law as interpreted by u.s. courts in light of experience and reason.'m the court held that "[a]t common law, no physician-patient privilege existed and, therefore, we recognize no such privilege in federal criminal trial today."38 30. /d. 31. committee on mental health, psychiatric communications privileged, 150 jama 1241 (nov. 22, 1952), available at http://jaffee-redmondorglcaseslbinder.btm (last visited mar. 7, 2005). 32. /d. 33. id 34. id 35. united states v. meagher, 531 f.2d 752 (5th cir. 1976). 36. id at 753. 37. id 38. id the court further examined this case and privilege with regard to the proposed rule of evidence, rule 504. the court found that if the proposed rule had been enacted, the defendant in this case would tall under one of the exceptions to the proposed rule. this is because a defendant in a criminal trial that claims insanity as a defense cannot utilize the psychotherapist-patient privilege. the other two exceptions in the proposed rule were for (1) 2006] duty tow arn-even if it may ·be hearsay? 177 after the decision to recognize a psychotherapist-patient privilege was rejected in meagher in 1976, other federal circuit courts addressed the same issue with differing conclusions. in 1983, the sixth·circuit looked at the language of proposed rule 504 and balanced whether the confidentiality interest of the patient successfully outweighed the evidentiary need. the court found that ''the balance tips in favor of the disclosure. "39 the court reasoned that although the main element of the privilege "is the assurance to the patient that his innermost thoughts may be revealed without fear,'' simply disclosing the patient's identity did not fall within the privilege.40 in that same year, the seventh circuit avoided the issue and ruled that the patient waives confidentiality when he gives his express consent to release the information to an insurance carrier,41 and the eleventh circuit ruled that confidentiality of medical records "[is] not absolute" and can be used as evidence.42 the eleventh circuit affirmed its decision in 1988 by definitively deciding that no psychotherapist-patient privilege should exist.43 finally in 1992, the second circuit analyzed the zuniga decision.44 the court looked to the forty-nine states and the district courts within the second circuit which had already enacted statutes establishing the psychotherapist­ patient privilege. 45 the court also examined cases in which the courts of appeals had not recognized the privilege.46 "following this turmoil in the courts of appeals which spanned almost twenty years, the supreme court granted certiorari in jaffee v. redmond to decide this important question.'147 2. the supreme court recognizes the psychotherapist-patient privilege it took until 1996 for the united states supreme court to establish the psychotherapist-patient privilege with its decision in jaffee v. redmond. jaffee was decided forty-four years after binder and twenty years after meagher. the cow:t called the decision to recognize. the psychotherapistproceedings for hospitalization stating that "no privilege under this rule for communications relevant to an issue in proceedings to hospitalize the patient for mental illness ... "and (2) examination by order of judge stating "[i]f the judge orders an examination of the mental or emotional condition of the patient, [these] communications ..• are not privileged .... " evidence handbook, supra note 27, at 135. 39. in re zuniga, 714 f.2d 632,640 (6th cir. 1983). 40. /d. 41. in re pebsworth, 705 f.2d 261,262 (7th cir. 1983). 42. united states v. lindstrom, 698 f.2d 1154, 1167 (lith cir. 1983). 43. united states v. corona, 849 f.2d 562,566-67 (lith cir. 1988). 44. in re doe v. diamond, 964 f.2d 1325, 1328 (2nd cir. 1992). 45. /d. 46. !d. 47. melanie stephens stone; jqffee v. redmond: the supreme court adopts a federal psychotherapist-patient privilege and extends the scope to encompass licensed social workers, 48 mercerl. rev. 1283. 1289 (1997); 178 indiana heallh law review [vol. 3:171 patient privilege as the ''ultimate societal expression of the need to provide absolute protection from disclosure of communications between psycho­ therapists and their patients."48 the court stated that the jaffee privilege does not have as many years of common law experience as the attorney-client privilege, but it recognized that ''(t]he way in which the new privilege develops is of major importance to all psychotherapists and their patients.',..9 a. facts in jaffee v. redmom/0 in jaffee, mary lu redmond received extensive counseling from a licensed social worker after a traumatic incident in which mary lu, a police officer, shot and killed a man, allen, while she was on duty. a suit was filed in federal district court claiming that mary lu "had violated allen's constitutional rights by using excessive force during the encounter at the [scene]."51 the fact that redmond had been receiving counseling became apparent to the plaintiff tturing pre-trial discovery. 52 b. procedural history in jaffee v. redmow/3 the plaintiff attempted to seek access to notes taken by social worker, beyer, to use for cross-examination. 54 the defendants resisted the discovery and asserted the notes. "were protected against involuntary disclosure by a psychotherapist-patient privilege. "55 even though the district judge rejected this argument, neither beyer nor redmond "complied with [the judge's] order to disclose the contents of beyer's notes [and] [a]t depositions and on the witness stand both either refused to answer certain questions or professed an inability to recall details of their conversations."" the district court judge instructed the jury "that the refusal to turn over beyer's notes had no 'legal justification' and that the jury could therefore presume that the contents of the notes would have been unfavorable to respondents. the jury awarded petitioner $45,000 on the federal claim· and $500,000 on her state-law claim.''s7 48. the federal psychotherapist-patient privilege: history, documents, and opinions, available at http://jaffee-redmond.org (last visited mar. 8, 2005). · 49. /d. 50. jaffee, 518 u.s. at 3-4. 51. /d. at5. 52. /d. 53. /d. 54. /d. 55. /d. 56. jaffee, 518 u.s. at 5-6. 57. /d. at 5-6. 2006] duty tow arn-even if it may be hearsay? 179 addressing the issue for the first time, the court of appeals for the seventh circuit reversed and remanded for a new trial. 58 the court stated "that 'reason and experience,' the touchstones for acceptance of a privilege under rule 501 of the federal rules of evidence, compelled recognition of a psychotherapist-patient privilege."59 the court explained that "[r]eason tells us that psychotherapists and patients share a unique relationship, in which the ability to communicate freely without the fear of public disclosure is the key to successful treatment. as to experience ... all [fifty] states have adopted some form of the psychotherapist-patient privilege. •>60 c. decision and rationale in jaffee v. redmoncf1 the case then moved to the supreme court which began its analysis by weighing the need for probative evidence with the need to recognize a psycho­ therapist-patient privilege.62 the court called the public's right to "every man's evidence" a "fundamental maxim.'>63 because the right for the public to hear all of a person's evidence is so imbedded in our judicial system, any exceptions, such as privileges, are "distinctly exceptional.'>64 the supreme court applied the same balancing test as the majority of other courts by weighing whether the public and private interests of those protected by the privilege were important enough to outweigh the fundamental maxim of using all available evidence in order to obtain the necessary truths.65 the court began by comparing the husband-wife and attorney-client privileges with the psychotherapist-patient privilege due to their common vital need for confidence and trust.66 the court concluded that because a psycho­ therapist's sessions depend on the patient willfully discussing potentially embarrassing facts, emotions, memories and fears, that if disclosed may cause embarrassment or disgrace to the patient, there is a need for the psycho­ therapist-patient privilege. 67 58. /d. at6. 59. id 60. /d. "the court also noted that, with one exception, the federal decisions rejecting the privilege were more than five years old and that the 'need and demand for counseling services has skyrocketed during the past several years.'" !d. 61. jaffee, 518 u.s. at 15. 62. ld at 9-10. 63. /d. at9. 64. /d. 65. /d. at 11. 66. jaffee, 518 u.s. at 10. 67. /d. 180 indiana health law review [vol. 3:171 ill. psychotherapist's duty-to-warn requirement a. history of the duty-to-warn requirement when federal rule of evidence 501 was adopted, it was very general and it did not provide any specific exceptions to the rule except in instances where common law, the united states constitution, united states supreme court, or congress provided a specific privilege exception. when the proposed rule 504 was introduced, it included three specific exceptions to the psychotherapist-patient privilege, 68 but it did not include an exception regarding dangerous persons. the advisory committee believed that patients who opened up and confessed dangerous thoughts and feelings about other people were unlikely to go and commit the crimes. also, if the patient knew their psychotherapist would be required to disclose the threat, the patient would not be free to communicate with his psychotherapist about all aspects of his problems that require treatment. "by intentionally excluding an exception for dangerous patients, the advisory committee showed great deference to the principle that the success of a psychotherapist depends upon his or her ability to communicate freely with a patient in a confidential setting. "69 the advisory committee left the decision to include a dangerous person exception to the psychotherapist-patient privilege to the courts, which led to the decisions in tarasoffl and tarasoffll. in 1969, prosenjit poddar killed tatiana tarasoff two months after poddar allegedly "confided his intention to kill" tarasoffto his psychologist, dr. lawrence moore.7° finally in 1974 (tarasoff /)and 1976 (tarasoff 1/), five and seven years, respectively, after tarasoff's death, the california supreme court, in tarasoffl, ruled that the psychotherapists and the hospital i 68. these exceptions in the proposed rule 504 read as follows: (1) proceedings for hospitalization. there is no privilege under drls rule for communications relevant to an issue in proceedings to hospitalize the patient for mental illness, if the psychotherapist in the course of diagnosis or treatment has determined that the patient is in need of hospitalization. (2) examination by order ofjudge. if the judge orders an examination of the mental or emotional condition of the patient, communications made in the course thereof are not privileged under this rule with respect to the particular purpose for which the examination is ordered unless the judge orders otherwise. (3) condition an element of claim or defense. there is no privilege under this rule as to communications relevant to an issue of the mental or emotional condition of the patient in any proceeding in which he relies upon the condition as an element of his claim or defense, or, after the patient's death, in any proceeding in which any party relies upon the condition as an element of his claim or defense. evidence handbook, supra note 27, at 135. 69. combs, supra note 28, at 461. 70. tarasoffv. regents ofuniv. of cal., 551 p.2d 334, 339 (cal. 1976) (taraso.lf/1}. 2006] duty tow arn-even if it may be hearsay'? 181 involved in poddar's care and treatment owed a duty-to-warn tarasoff of the threats made by poddar,71 and the court furthered this in tarasoff ii by also ruling the psychotherapists and hospital had a duty to protect tarasoff from poddar.72 the court stated, "[w]e conclude that the public policy favoring protection of the confidential character ofpatient-psychotherapistcommunica­ tions must yield to the extent to which disclosure is essential to avert danger to others. the protective privilege ends where the public peril begins.'m the tarasoff ii court further discussed the societal ills of its time. it described society as a "risk-infested society'' unable to tolerate any more exposure to danger from concealing patient threats. 74 the court concluded that in order to exercise reasonable care and, if possible, to protect an intended victim by providing a warning, ''we see no sufficient societal interest that would protect and justify concealment. the containment of such risks lies in the public interest. "75 b. current status of the duty-to-warn requirement 1. federal courts that do not recognize the duty-to-wam requirement a. united states court of appeals-sixth circuit (1) facts in united states v. hayes16 roy lee hayes was the union steward for a post office. branch in marion, virginia where he worked his entire adult life.77 on february 9, 1998, "hayes sought professional help at the veterans administration mountain home hospital (mhh)" in johnson city, tennessee following erratic behavior at work and occasional depression so deep that he was unable to function. 78 at mhh he was diagnosed with "major depression accom­ panied by severe psychotic features.'m during treatment, hayes admitted to his psychotherapist, dr. dianne hansen, his desire to kill his boss, veda odie. 80 hayes said that he could resist this urge because he knew such action would mean possibly losing his job. 81 dr. hansen released hayes on february 71. tarasoffv. regents ofuniv. of cal., 529 p.2d 553,561 (cal. 1974) (taraso.f/1). 72. taraso.f/ii, 551 p.2d at 348. 73. jd. at 347. 74. jd. 75. /d. 76. united states v. hayes, 227 f.3d 578, 580 (6th cir. 2000). 77. /d. at 580. 78. jd. 79. jd. 80. jd. 81. hayes, 221 f .3d at 580. 182 indiana health law review [vol. 3:171 18 and told him he could go back to work on february 23.82 she also instructed him to contact his health care provider. it was noted in mhh's records that dr. hansen planned on warning odle of the threat, but "it is undisputed the odle never received any warning from the staff at mhh. "83 on march 31, hayes attended a session with james van dyke at the veterans center in johnson city, tennessee.84 this time hayes described, in great detail, how he planned to kill odle. he even fully described the layout of odie's home as well as his knowledge of "when she would be home alone. "85 van dyke advised hayes that these threats "could not be kept confidential."86 van dyke waited until the next day to warn odle of the threats and did so after speaking with the veterans center's legal counsel and being advised he had a legal obligation to warn odie of the threat that hayes posed.s1 (ii) procedural history in united states v. hayes88 a magistrate judge held ''that the 'threat' revealed toodle by van dyke was not privileged because that revelation was the 'only means' of averting harm to odle."89 the district court, however, held to the contrary because it found van dyke's disclosure of information was not ''the only means of averting harm," and he could not testify at trial.90 the court then granted hayes' motion to exclude the testimony of his psychotherapists. the psychotherapists' testimony was the basis of all of the charges brought against hayes. the district court then dismissed the case and the government immediately appealed. (ill) holding and reasoning in united states v. hayes91 the sixth circuit court in hayes held there is not a dangerous person exception to the federal psychotherapist-patient privilege.92 the psycho82. jd. 83. /d. 84. james van dyke was employed as a social worker at the veterans center in johnson city, tennessee. id. 85. /d. at 580. 86. hayes, 227 f .3d at 580. 87. /d. 88. /d. at 581. (all procedural history in following paragraphs is found in u.s. v. hayes, 227 f.3d 578,581 (6th cir. 2000)). 89. /d. 90. /d. 91. hayes, 227 f.3d at 580. 92. /d. at 584-85. 2006] duty tow arn-even if it may be hearsay? 183 therapist does not have a professional or ethical duty to protect third persons. 93 the court gave three distinct reasons for rejecting the duty-to-warn. 94 first, the court cautioned that there would be a chilling effect from the knowledge that the psychotherapist has a duty-to-warn concerning statements made by the patient to the psychotherapist. the court reasoned that the chilling effect would be even greater if the patient is aware his statements can be used against him in a criminal proceeding.95 the court recognized both the importance placed on mental health by the supreme court and the conse­ quences of a dangerous person exception. 96 the hayes court indicated a dangerous person exception ''would have a deleterious effect on the 'atmos­ phere of confidence and trust' in the psychotherapist/patient relationship.'t97 second, the hayes court looked to the ways the exception would serve the public interest. 98 it referred to jaffee footnote 1999 in recognizing two interests: (1) "the improvement of our citizens' mental health achieved, in part, by open dialogue in psychotherapy ... and [2] the protection of innocent third parties .... " 100 because both are public concerns, the hayes court believed jaffee footnote 19 was "no more than an aside by justice stevens to the effect that the federal psychotherapist/patient privilege will not operate to impede a psychotherapist's compliance with the professional duty to protect identifiable third parties from serious threats of harm. " 101 lastly, the court stated that "reason and experience" have taught us that adopting a dangerous person exception in federal common law would be "ill-advised."102 b. united states court of appeals-ninth circuit (i) facts in united states v. chase103 during numerous sessions with his psychiatrist, dr. kay dieter, steven chase disclosed that he had a list of people written in his day planner that he planned to kill. he showed the day planner to dr. dieter, but chase told dr. 93. id. at 586. 94. id. 584-86. 95. hayes, 227 f.3d 578, 585. 96. id. 97. id. at 584. 98. id. at 585. 99. the hayes court is referring to footnote 19 of the jaffee opinion which reads: although it would be premature to speculate about most future developments in the federal psychotherapist privilege, we do not doubt that there are situations in which the privilege must give way, for example, if a serious threat ofharm to the patient or to others can be averted only by means of a disclosure by the therapist. jaffee v. redmond, 518 u.s. 1, 18 n.19 (1996). 100. hayes, 227 f.3d at 585. 101. id 102. id at 585-86. 103. united states v. chase, 340 f.3d 978,979-81 (9th cir. 2003). 184 indiana health law revjew [vol. 3:171 dieter that "he had no intention to act immediately on his homicidal thoughts. "104 a few months later, chase became upset after an argument with his wife. he called dr. dieter and told her about a life insurance policy he had that would pay if something should happen to him. in light of fears that chase was losing his support system, and after discussion with the legal department at her treatment facility, dr. dieter contacted local police who then contacted the fbi. 105 dr. dieter testified concerning the contents of these therapeutic sessions. (ii) procedural history in united states v. chase106 at trial, chase challenged the admissibility of dr. dieter's testimony under the psychotherapist-patient privilege.107 "the district court held that dr. dieter's testimony was admissible" reasoning "that the federal psycho­ therapist-patient privilege did not apply because ... [chase's] threats were serious when uttered, that harm was imminent, and that disclosure to authorities was the only means of averting the threatened harm. "108 chase was found guilty and appealed the conviction. a three-judge panel affirmed both the court's ruling and the conviction. the ninth circuit court agreed to hear the case en bane. (ill) holding and reasoning in united states v. chase109 the ninth circuit court first discussed the oregon state law because chase's counseling sessions were conducted in oregon. oregon has a discre­ tionary exception to the confidentiality requirement between a psychotherapist and patient. relying on this rule as well as jaffee footnote 19, the chase court held that dr. dieter properly disclosed the threats. no however, the main issue of the case rested on whether the court should recognize a dangerous 104. jd. at 979. 105. the fbi was contacted because chase's list contained the names of two fbi agents he wanted to kill as revenge for not adequately protecting him. jd. at 981. 106. chase, 340 f.3d at 979. 107. id at 981. 108. id. 109. chase, 340 f.3d at 992. 110. ld. at 985. the court first looked at how confidentiality between a patient and physician is protected by various statutes in oregon including or. rev. stat. § 677.190(5) (2003)(statingthat"[w]illfullyornegligentlydivulgingaprofessionalsecretwithoutthewritten consent of the patient" is grounds for revoking or refusing to grant a license, registration or certification to practice medicine); or. rev. stat. § 430.399(5) (2003) (stating "[t]he records of a patient at a treatment facility shall not be revealed to any person other than the director and staffofthe treatment facility without theconsentofthepatient."); and or. rev. stat.§ 40.230 (2005) (stating a patient may refuse to disclose and prevent anyone else from disclosing, "confidential communications made for the purposes of diagnosis or treatment ... "). 2006] duty tow arn-even if it may be hearsay? 185 patient exception to the federal testimonial privilege, which may arise from the dangerous-patient exception in state rules of confidentiality.111 the chase court declined to recognize a dangerous-patient exception to the federal testimonial privilege.112 the court reasoned that allowing the exception to the federal testimonial privilege would "significantly injure the interests justifying the existence of the privilege; would have little practical advantage; would encroach significantly on the policy prerogatives of the states; and would go against the experience of all but one of the states in our circuit, 113 as well as the persuasive proposed rules."114 2. texas does not recognize the duty-to-warn requirement a. facts in thapar v. zezulk:am dr. renu thapar was a psychiatrist who had been treating freddy ray lilly since 1985.116 lilly was diagnosed "as suffering from moderate to severe post-traumatic stress disorder, alcohol abuse, and paranoid and delusional beliefs concerning his stepfather, henry zezulka, and people of certain ethnic backgrounds."117 in 1988, lilly told dr. thapar that he felt like killing henry zezulka but that he had decided not to go through with it. 118 within a month after his release, lilly shot and killed henry zezulka.119 dr. thapar did not warn zezulka or law enforcement officials of lilly's threat.120 111. chase, 340 f.3d at 985. the oregon exception applies to the confidentiality requirement. the rule to which the court is referring does not impose neither a duty to disclose the threat nor any civil liability on the psychotherapist for failing to disclose the threat. the statute reads as follows: (12) information obtained in the course of diagnosis, evaluation or treatment of an individual that. in the professional judgment of the health care services provider, indicates a clear and immediate danger to others or to society may be reported to the appropriate authority. a decision not to disclose information under this subsection does not subject the provider to any civil liability. or. rev. stat.§ 179.505(12) (emphasis added). 112. chase, 340 f.3d at 991. 113. id. at 992. the court analyzed the dangerous-person exception in the state of washington. in washington, the therapist can testify under the dangerous-patient exception "because his therapist permissibly had disclosed a communication under state law." id. at 988. 114. /d. referring to proposed rule 504 of the federal rules of evidence. 115. thapar v. zezulka, 994 s.w.2d 635,636 (tex. 1999). 116. id. 117. id. 118. id. 119. id. 120. thapar, 994 s.w.2d at 636. 186 indiana health law .revjew [vol. 3:171 b. holding and reasoning in thapar v. zezulka121 appealing from a summary judgment, the texas supreme court viewed evidence in the light most favorable to lyndall zezulka, the nonmovant. 122 the court began its analysis by determining whether or not a duty exists to warn a third-party of a patient's threat by looking to the confidentiality statute that governs the mental health profession in the state of texas. three years after tarasoffll in 1979, the texas legislature enacted a statute "governing the disclosure of communications during the course of mental-health treatment."123 texas' confidentiality rule does not have an exception that allows disclosure to third parties, though the rule permits disclosure of confidential information to medical or law enforcement personnel.124 nonetheless, the court stated that "[i]mposing a legal duty to warn third parties of patient's threats would conflict with the scheme adopted by the legislature by making disclosure of such threats mandatory,"125 and that imposing a common-law duty to warn on mental-health professionals imposes a "[ c ]atch-22. they either disclose a confidential communication that later proves to be an idle threat and incur liability to the patient, or they fail to disclose a confidential communication that later proves to be a truthful threat and incur liability to the victim and the victim's family."126 the thapar court stated, ''we decline to adopt a duty to warn now because the confidentiality statute governing mental-health professionals in texas makes it unwise to recognize such common-law duty."127 121. thapar, 994 s.w.2d at 640 (tex. 1999). 122. /d. at 636. 123. id. at 638. today, the statute the thapar court referred to reads as follows: communications between a patient and a professional, and records of the identity, diagnosis, evaluation, or treatment of a patient that are created or maintained by a professional, are confidential. (b) confidential communications or records may not be disclosed except as provided by section 611.004 or 611.0045. (c) this section applies regardless of when the patient received services from a professional. tex. health&. safety code ann. § 611.002 (2004). 124. see tex. health& safety code ann. § 611.004(a)(2)(2005)(which reads: (a) a professional may disclose confidential information only: (2) to medical or law enforcement personnel if the professional determines that there is a probability of imminent physical injury by the patient to the patient or others ... ") (emphasis added). 125. thapar, 994 s.w.2d at 639. 126. /d. at 640. 127. ld. at 638. 2006] duty tow arn-even if it may be hearsay? 3. states that recognize the duty-to-warn requirement128 a. pennsylvania (i) facts in emerich v. philadelphia ctr.for human dev., inc.'29 187 on june 27, 1991, gad joseph fatally shot his girlfriend, teresa hausler. prior to doing so, he called his counselor, anthony scuderi, to inform him of his intentions. scuderi immediately met with joseph during an emergency therapy session and suggested joseph admit himself to a psychiatric hospital. joseph refused this suggestion stating that, "he was in control and would not hurt ms. hausler."130 based on this statement, scuderi let joseph leave the session. about thirty minutes later, joseph shot and killed hausler after which he telephoned scuderi.131 scuderi, upon direction of the executive director of the center, notified police.132 (ii) procedural history in emerich v. philadelphia ctr. for human dev., inc. 133 after joseph was convicted of murder, hausler's estate brought suit against the treatment center, scuderi, and the director of the center. the trial court granted judgment in favor of the health center and the superior court affirmed by reiterating the trial court's reasoning that at the time of the ruling, there was no duty-to-warn a third party requirement in pennsylvania law. however, if such a duty did exist, "[a]ppellant failed to establish a cause of 128. to date, the only federal court to n:cognize an exception to the psychotherapist-patient privilege is the tenth circuit court of appeals. the tenth circuit relied on footnote 19 in jaffee when it remanded a case to the district court to determine whether the threat made by the defendant "was serious when it was uttered and whether its disclosure was the only means of averting harm to the president when the disclosure [by the psychotherapist] was made." united states v. glass, 133 f.3d 1356, 1360 (loth cir. 1998). (upon voluntarily entering a hospital for ongoing mental illness, glass stated to his psychotherapist that he wanted to shoot president and mrs. clinton in order "to get in the history books." !d. at 1357. days later glass was released on condition that he remain with his father and attend outpatient therapy. /d. ten days later, only after discovering glass bad left his father's residence, local law enforcement and ultimately the secret service were advised of glass' threats against president and mrs. clinton. !d. because there was a ten day interval between the threat and the notification of law enforcement, the tenth circuit court remanded the case to the district court to determine the extent of the seriousness of glass' threat. /d. at 1357-60. 129. emerich v. philadelphia ctr. for human dev., inc., 720 a.2d 1032, i 034 (pa. 1998). 130. !d. at 1035. 131. !d. 132. /d. 133. emerich, 720 a.2d at 1035. 188 indiana health law review [vol. 3:171 action as his decedent was killed when she ignored mr. scuderi's warning not to go to joseph's apartment."134 (ill) rationale in emerich v. philadelphia ctr. for human dev., inc. m in a case of first impression, the supreme court ofpennsylvania stated, ''the concept of a duty to protect by warning, albeit limited in certain circumstances, has met with virtually universal approval."136 the emerich court relied on public policy principles when it found a duty-to-warn. the court looked to duty and the concept that duty "'amounts to no more than the sum total of those considerations of policy which led the law to say that the particular plaintiff is entitled to protection from the harm suffered. "'137 continuing its analysis, the court examined the societal interest regarding the protectionofpennsylvania'scitizensftomharmbyimposingtheduty-to-warn. "simply stated, it is reasonable to impose a duty on a mental health professional to warn a third party of an immediate, known and serious risk of potentially lethal harm."138 b. delaware (i) facts in state of del. v. bright139 rodney. bright was a united states veteran and had been seeking treatment at various veterans' administration facilities for over twenty years. bright was diagnosed and suffered from manic depression and bi-polar disorder. he had made various threats to harm his ex-wife, but it was not until december 9, 1994, that bright contacted his psychiatrist, dr. mayetta, and told her that he was leaving that day to drive to delaware to kill is ex-wife. . he told dr. mayetta that ''he had several weapons'' and he was either going to shoot [his ex-wife] or "strangle her with his bare hands."140 dr. mayetta contacted local law enforcement officials. bright was consequently arrested only a mile and half from his ex-wife's workplace. at the time of his arrest, bright possessed a knife, duct tape and rope. 134. id. at 1035. 135. emerich, 120 a.2d at 1043. 136. /d. at 1037. 137. /d. at 1039. (quotingmazzagatti v. everingham by everingham, 516 a.2d672, 678 (pa. 1986)). . 138. id 139. state ofdel. v. bright, 683 a.2d 1055, 1058-59 (del. super. ct. 1996). 140. /d. at 1058. 2006] duty tow arn-even if it may be hearsay? 189 (ii) procedural history in state of del. v. bright141 the bright case was an opinion issued upon bright's motions to suppress. "bright filed two motions to suppress certain evidence relating to statements made by him to medical personnel at an out-of-state veterans' administration hospital. "142 one ofbright's grounds to suppress the evidence was that dr. mayetta violated the physician-patient privilege when she disclosed the threatening statements to law enforcement officials. 143 (ill) rationale in state of del. v. bright144 the delaware superior court held that dr. mayetta's disclosure of bright's threats against his ex-wife did not violate the psychotherapist-patient privilege.145 the court began its discussion on the issue of the psycho­ therapist-patient privilege by recognizing that "confidentiality statutes exist along with the well-recognized law of privileges, ... [and that] [t]he federal statutes and the law of privilege both encompass a similar purpose: to facilitate communication between the patient and the therapist."146 since 141. id. at 1058-59 (del. super. ct. 1996). 142. id. (at the time of his treatment, bright was seeking medical attention from dr. mayetta at a veterans' administration filcility in indianapolis, indiana.) 143. id. at 1059. bright's other bases for his claim were (or included) that "dr. mayetta acted as an agent for the prosecution when she questioned bright; thereby, rendering his statements involuntary under the fifth amendment . . . [and] that a federal confidentiality statute, 42 u.s.c. § 290dd-2(c), prohibit[ed] the use of records relating to substance abuse programs in criminal proceedings." bright, 683 a2d at 1059. on these points, the delaware superior court held that dr. mayetta did not violate bright's fifth amendment rights when he reported the threatening remarks. ld. at 1065. distinguishing from united states v. d.f., 63 f.3d 671 (7th cir. 1995), the court held that dr. mayetta "was not acting as an agent for the (government] merely because she was employed by a government facility." bright. 683 a2d at 1060. furthermore, she "did not coerce bright into confessing his involvement in any crime so that be could be punished[;] ... (but] [i]nstead [she] attempted to treat bright for his mental [conditions] ... duringwhicbshediscovered"his intention to harm his ex-wife. id. at 1060-61. the court also found that the federal confidentiality statute did not apply to the given situation due to bright's reliance on a statute that applied to persons being treated in federally assisted drug and/or alcohol treatment programs. because bright wasn't being treated for drug or alcohol abuse and the disclosure of the statements was not derived ftom treatment of drug or alcohol abuse counseling. the federal statutes did not apply in this case. id. at 1062. 144. bright, 683 a.2d 1064. 145. id. 146. id. the court referred to the delaware physician and psychotherapist-patient privileged statute in footnote 16 of the opinion, which reads, i.il part: (1) a communication is 'confidential' if not intended to be disclosed to third · persons .... " and (b) general rule of privilege. a patient has a privilege to refuse to disclose and to prevent any other person from disclosing confidential cojdlllunications made for the purpose of diagnosis or treatment of the patient's physical, mental or emotioilal condition, including alcohol or drug addiction, among the patient, the patient's mental health provider, physician or psychotherapist, and persons who 190 indiana health law review [vol. 3:171 confidentiality statutes and laws of privilege can co-exist, the exceptions to these statutes and laws can also co-exist. the court identified the duty-to­ warn exception as a "well established exception. ''147 quoting the reasoning in tarasoff ii as well as another delaware supreme court case, 148 the bright court stated that not only do "mental health professionals have a duty of confidentiality to their patients, they also have an affirmative duty to persons other than· the patient to exercise reasonable care in the treatment and discharge of such patients."149 the court defined reasonable care to include "a 'duty to warn potential victims or a class of potential victims and/or control, to some appropriate degree, the actions ofthe patient."'150 iv. the impucations of the ewing decisions a. holding and rationale in ewing v. goldstein151 in the ewing decisions, the courts extended a statute· and statutory definitions beyond their ordinary meanings. ewing v; goldstein was the first of the two ewing cases to be decided.152 the appellate court reviewed the trial court's construction of california civil code 43.92 and determined that it was ''unduly narrow."153 the trial court determined ''the ewings had failed to satisfy the statutory requirements necessary to defeat the psychotherapist's immunity, because 'the patient himselr had not communicated the threat to the therapist."154 california civil code section 43.92 establishes the duty of a psychotherapist to warn and protect an identifiable third person.155 the statute bars any monetary liability on the part of; and no cause of action shall · arise against, any person who is a psychotherapist . . . in failing to warn of and protect from a patient's threatened violent behavior or failing to predict and warn of and protect are participating in the diagnosis or treatment under the direction of the mental health provider, physician orpsychotherapist. including members ofthe patient's family. del. code ann. d.r.e. §§ 503(ax4). (b) (1996). 147. bright, 683 a.2d at 1064. 148. the other delaware supreme court case that the bright court relied on was naidu v. laird, 539 a.2d 1064 (del. 1988). 149. bright, 683 a.2d at 1064 (emphasis added). 150. id (quotingnaidu, 534 a.2d at 1073 (del. 1988)). 151. goldstein, 15 cal.rptr.3d at 875. 152. id. . 153. id at 868. 154. id. 155. cal. civ. code§ 43.92(a) (west 2004). 2006] duty tow arn--even if it may be hearsay? from a patient's violent behavior except where the patient has communicated to the psychotherapist a serious threat of physical violence against a reasonably identifiable victim or victims. 156 191 the court of appeals began its analysis by looking at the statutory construction of this statute. quoting a 2002 california court of appeals case, allen v. sully-miller contracting co.,157 the court stated, "'(u]ltimately we choose the construction that comports most closely with the apparent intent of the lawmakers, with a view to promoting rather than defeating the general purpose of the statute."'158 the court then looked at balancing the interests the statute was protecting and finally examined whether the information can come from the patient's family. "a 'patient' is defmed as 'a person who consults a psychotherapist or submits to an examination by a psychotherapist for the purpose of securing a diagnosis or preventive, palliative, or curative treatment of his mental or emotional condition."159 the court recognized the dichotomy present in section 43.92. "section 43.92 represents a legislative effort to strike an appropriate balance between conflicting policy interests."160 the policy interest the court refers to is the ''need to preserve a patient confidence [in order to achieve] an effective diagnosis and treatment of a mental illness or an emotional problem [that can be] severely undermined when a patient cannot be assured that a statement made in the privacy of his therapist's office will not be revealed."161 the conflicting interest as stated by the court is "under limited circumstances, preserving a confidence is less important than protecting the safety of someone whom the patient intends to harm."162 the court determined that this balancing of interests did not apply in this case because there was not a confidence to be protected. this is because the confidence arises from the confidential relationship between a psychotherapist and the patient victor colello was not in any type of relationship with dr. goldstein that would trigger the confidence. the confidential relationship was between geno and dr. goldstein. requiring dr. goldstein to warn keith ewing was not warranted because there was no confidence that needed protecting and therefore, no duty should have been imposed. 156. /d. 157. allen v. sully-miller contracting co., 120 ca. rptr. 2d 795 (cal. ct. app. 2002). 158. goldstein, 15 cal. rptr. 3d at 869. (quoting sully-miuer contracting co., 120 cal. rptr. 2d at 798). 159. /d. (emphasis added) (quoting cal. evid. code §loll). 160. id at 871. 161. /d. 162. /d. (emphasis added). 192 indiana health law review [vol. 3:171 prosser says that "duty'' is the only word in law where the conclusion of liability is stated in just one word. 163 · he continues that "many factors interplay: the hand of history, our ideas of morals and justice, the convenience of administration of the rule, and our social ideas as to where loss should fall."164 a classic english definition of duty maintains that "when circumstances place one individual in such a position with regard to another ... ordinary sense would recognize the danger of injury to the other .... "165 in this case, it would take more than simple ordinary sense for dr. goldstein or northridge hospital medical center to recognize the danger that geno posed to keith ewing. there was no communication from geno, and a duty­ to-warn requirement normally emerges out of the private, confidential communications between a doctor and the patient. the goldstein eourt also determined that a situation: when the communication of the serious threat of physical violence is received by the [psycho ]therapist from a member of the patient's immediate family166 and is shared for the purpose of facilitating and furthering the patient's treatment, the fact that the family member is not technically a'patient' is not crucial to the statute's purpose.167 163. william l, prosser, palsgrafrevisited, 52 mich. l. rev. l, 15 (1953). 164. ld. 165. marshalls. shapo, the duty to act: tort law, power & public policy xi (univ. oftex. 1977) (emphasis added). 166. goldstein, 15 cal. rptr. 3d at 871-72. the goldstein court did not definitively define "immediate family" member. there are many differing definitions of "immediate family" in california codes. see caibus. & prof. code§ 3625( c x2) (west 2004) (defining "immediate family" as "spouse, parents, children, or his or her children's spouses"); cal. educ. code§ 67360(cxl) (west 2004) (defining "immediate family" as "spouse, child, parent, stepparent, grandparent, grandchild, brother, sister, parent-in-law, brother-in-law, sister-in-law, nephew, niece, aunt, uncle, or first cousin, or the spouse of any of those persons, or guardian of any of those persons"); caigov'rcode § 51230.l(c) (west2004) (defining "immediate family" as "spouse of the landowner, the natural or adopted children of the landowner, the parents of the landowner, or the siblings of the landowner"); cal. gov't code § 82029 (west 2004) (defining "immediate family" as "spouse and dependent children"); cal. penal code § 217.1(cx1) (west 2004) (defining "immediate family'' as spouse, child, stepchild, brother, stepbrother, sister, stepsister, mother, stepmother, father, or stepfather); cal. penal code§ 422 (west 2004) (defining "immediate family" as "any spouse, whether by marriage or not, parent, child, any person related by consanguinity or affinity within the second degree, or any other person who regularly resides in the household, or who, within the prior six months, regularly resided in the household"); cal. sr. rules app. drv. 6 standard 2n (west 2005) (defining "immediate family'' as "spouse or domestic partner and any minor child living in the arbitrator's household"). · 167. goldstein, 15 cat. rptr. 3d at 871-872 (emphasis added). 2006] duty tow arn---:-even if it may be hear.sa y? 193 the court reasoned that a person's emotional problems do not "exist in a vacuum"168 and discussed that all aspects of the patient's life have an impact on the patient's emotional and mental health. the court stated that even if communication during therapy is given by a family member, these communications need to be protected in order to further "the patient's therapy by giving the therapist a fuller understanding of the problem or illness for which his or her expertise is needed by encouraging the patient and his or her family members to fully disclose information they might otherwise be embarrassed or reluctant to reveal. " 169 therefore, the court is trying to extend the blanket of confidentiality over the patient's immediate family member. congress refused to enact legislation to add the psychotherapist-patient privilege to the federal rules of evidence by enacting rule 501 instead. it took many state courts and finally federal courts over twenty years to even begin to recognize the need and requirement of a psychotherapist-patient privilege. now, the california court of appeals has broadened this privilege and has extended this confidentiality to immediate family members of the patient by saying this communication has to be protected in order to further the treatment and diagnosis of the patient. this goes far beyond the scope and intent of the california statute. the court wants to make sure that a patient's treatment is achieved by protecting the immediate family member's communications about diagnosis and treatment and holding the doctors and hospital liable for these types of communications. however, neither of the ewing decisions specifically defined "immediate family member." knowing there are differing definitions of"family member" within california legislation, 170 the court stated that this case and opinion does not address or concern situations where someone other than a patient's immediate family "conveys the information of the patient's potential dangerousness to the therapist. "171 the court was very concerned about applying the balancing test between ensuring the patient was being treated and protecting the intended third-party victim. why stop with immediate family members if the most important thing is to protect the victim and further the patient's treatment for mental illness? b. holding and rationale in ewing v. northridge hosp. med. ctr. 172 the northridge case was decided only eleven days after the goldstein case. it was argued before the same court and the same judge wrote both opinions. the northridge decision relied entirely on the opinion in goldstein 168. /d. at 872. 169. /d (emphasis added). 170. see supra text accompanying note 166. 171. goldstein, 15 cal. rptr. 3d at 873 n.10. 172. ewing v. northridge hosp. med. ctr., 16 cal rptr. 3d 591, 593-94 (cal. ct. app. 2004). 194 indiana heal til law review [vol. 3:171 and stated "[t]he pivotal factual question is whether the psychotherapist actually held the belief or made the prediction. if so, it does not matter that the belief or prediction was premised, in some measure, on information derived from a member of the patient's family."113 the california statute on which bothewingcourts rely does not mention anything about the psychotherapist actually holding a belief or prediction of the violent propensities of the patient. instead, the statute specifically states that there is a duty when the patient has communicated the threat to the psychotherapist.174 c. slippery slope the california court of appeals has created both ewing courts claim that part of each decision is based on the statutory ·construction and the legislative intent of a statute, but instead of clearing up any discrepancies, inconsistencies or confusions, they have created them. the courts went beyond the scope of a statute that was enacted to protect along-held psychotherapist-patientprivilege. the statute allowed only one exception to this well-recognized privilege that protects a patient's privacy and confidentiality during the patient's mental health treatments. the ewing courts have taken this one exception and have now opened the floodgates oflitigation. the door has been opened for more people to claim that some person told another person that they were going to injure someone else, and then ultimately hold the doctor to an affirmative duty on this third­ party information. california code section 43.92(a) plainly states that the communication must come from the patient to the psychotherapist.11s the ewing courts went too far outside the bounds of the statute and legislative intent. the general rule for statutory construction in california states, "the judge is simply to ascertain and declare what is in terms or in substance contained therein, not to insert what has been omitted, or to omit what has been inserted . .•. ''176 the majority certainly inserted "family member" into this statute and thus broadened the definition of ''patient communication," which, in tum, broadened the statute. if the legislature intended to include family members in the statute, it would have done so, especially given the numerous definitions of family member provided in certain california codes. 177 the ewing courts have also brought confusion into the california mental health profession. until now, psychotherapists in california have had a duty­ to-warn an intended third party of imminent harm from threats made by the psychotherapist's patient. now a psychotherapist has to try and determine 173. /d. at 596 (emphasis added). 174. cal. c!v. code§ 43.92(a) (west 2005). 175. /d. 176. cal. c!v. proc. code§ 1858 (deering 2004). 177. see supra text accompanying note 166. 2006] duty tow arn-even if rr may be hearsay? 195 whether or not the infonnation provided by a patient's family member imposes this same duty. in almost all circumstances, the family member will not be a patient of the psychotherapist. the psychotherapist will have to determine the mental state of the person conveying the information by determining not only whether the threat can cause imminent harm to an intended third-party victim but also whether the threat is valid. it will be nearly impossible, without obtaining the necessary background and history, for the psychotherapist to properly assess the mental state of the information provider ("family member'') and to ultimately decide if the information that has been provided triggers the duty-to-warn requirement. the california supreme court in tarasoff ii recognized the difficulty that a psychotherapist has in trying to forecast whether a patient presents a serious danger to an intended victim.178 the court does not expect the therapist to ''render a perfect performance {but] the therapist need only exercise 'that reasonable degree of skill, knowledge, and care ordinarily possessed and exercise by members of [that professional specialty] under similar circumstances. "'179 there has never been a similar circumstance in dr. goldstein's situation. the california court of appeals has gone beyond the california supreme court's decision in tarasoff ii when it decided that dr. goldstein's recommendation of hospitalization was inadequate and that he should have also warned keith ewing or law enforcement officials about geno's threat. the tarasoff ii court also stated that a ''therapist is free to exercise his or her own best judgment without liability; proof, aided by hindsight, that he or she judged wrongly is insufficient to establish negligence."180 dr. goldstein did exercise his best judgment in this case. he had a conversation with geno's father and advised him to take geno to the hospital. again, dr. goldstein never examined or talked to geno. his best judgment was to advise hospitalization and that should be all that is required of him in this circumstance. the court has decided to take the "proof, aided by hindsight" approach to this situation;181 there is no way dr. goldstein could have truly known geno 's intent or seriousness of the threat without the threat being conveyed directly to dr. goldstein. the pennsylvania supreme court in emerich, relying on tarasoff, stated that there must be a special relationship between the defendant and ''the person whose conduct needs to be controlled .... "182 both the tarasoff courts and the emerich court analyzed the issue of whether a patient and a 178. tarasoffv. regentsofuniv. ofcal., 551 p.2d334, 345 (cal. 1976). 179. id. 180. jd. 181. ld. 182. emerichv.pbiladelphiactr.forhumandev.,lnc., 720a.2d 1032, 1036(pa.1998). 196 indiana health law review [vol. 3:171 psychotherapist fall under the definition of special relationship.183 in the ewing cases, the relationship between dr. goldstein and geno colello fell under the definition· of special relationship as described by the tarasoff and emerich courts, but there was no special relationship between victor colello and dr. goldstein. 184 the tarasoff and emerich courts point out that the relationship between physicians and patients is one of the main reasons to justify imposing the duty-to-warn. the tarasoff ii court stated that because the therapist "becomes sufficiently involved" in the patient's life, the therapist assumes "some responsibility,. for the safety of the intended third-party victim.185 the emphasis is always on whether a special relationship exists. the special relationship allows the psychotherapist to delve into the patient's personal life and understand private intricacies like tone of voice and whether similar threats have been made in past. there was no way for dr. goldstein to know exactly geno's condition. he never saw or spoke to geno prior to or during geno's hospitalization. all dr. goldstein had to rely on was a telephone call from victor colello. the california court of appeals felt that this one telephone call was enough to impose a duty upon dr. goldstein. the northridge court stated, so long as the therapist believes in the validity of the family member's statements, it is immaterial that the statements themselves do not come from the patient him/herself. the court specifically said, "it does not matter'' that the communication came from someone other than the patient. 186 however, it has to matter, especially given that neither ewing court definitively determined who is considered a family member. the goldstein court refused to define exactly what an immediate family member was and also refused to further consider what would happen if the communi­ cation came from someone other than a non-defined family member. 183. see tarosoffll, 551 p.2d at 343-44; tarosoffl, 529 p.2d at 557-59; emerich, 120 a.2d at 1036-37. (all three courts refer to the second restatement second of torts in supporting the view that a duty arises only in the existence of a special relationship. the restatement reads as follows: there is no duty so to control the conduct of a third person as to prevent him from causing physical harm to another unless (a) a special relation exists between the actor and the third person which imposes a duty upon the actor to control the third person's conduct, or (b) a special relation exists between the actor and the other which gives to the other a right to protection. restatement(second)oftorts§315(2004).restatement(second)oftorts: dutyto control conduct of third persons§ 315 (1965)). 184. ewing v. goldstein, 15 cal. rptr. 3d 865 (cal. ct. app. 2004). it may be that a special relationship as· described in the cases and the restatement did not exist between art capilla, an employee of the hospital, and geno colello. it is not probable from one brief meeting with geno prior to his admittance into the hospital and one conversation with victor colello that the special relationship as described in the restatement existed between art and geno. however, this article will not address or analyze whether a duty-to-warn should have ever existed between the hospital and the ewings in light of the tact that a special relationship may or may not have existed between the social worker, hospital and geno colello. 185. tarosoff//, 551 p.2d at 344. 186. ewing v. northridge hosp. med. ctr., 16 cal. rptr. 3d 591, 596 (cal. ct: app. 2004). 2006] duty tow arn-even if it may be hearsay? 197 in america today, there are many different definitions offamily. many people live in households with what most would consider an "immediate family member." according to the 2000 census, there were 12,900,103 females that headed households with no husband present187 and 5,771,671 grandparents were the caregivers of one or more grandchildren under eighteen. 188 there are at least 250,000 children in the united states being raised in same-sex households with one-fifth ofthe gay male couples and one­ third of the lesbian couples identified in the 2000 census living in households with children. 189 the 2000 census reported 65 8, 711 same sex couples were living in the united states in the same house. 190 these numbers are staggering. is a same-sex partner a family member? is a woman raising her best friend's child a family member? is a grandparent an immediate family member? the goldstein court left a gaping hole in california law when it decided not to address or define "immediate family member," butstill held a psychotherapist to an affirmative duty based on information obtained from a non-defined "immediate family member." a case involving the communica­ tion to a psychotherapist by someone other than the patient has not been an issue in any other jurisdiction in the united states. however, other states have similar statutes and psychotherapist-patient privilege exceptions. a louisiana statute states that a psychotherapist will be not liable for breaking the confidentiality of their patient "[w]hen [the] patient has communicated a threat of physical violence ... against a clearly identified victim or victims, coupled with the apparent intent and ability to carry out that threat."191 similarly, an indiana statute states that a mental health provider is not subject to civil liability if they fail to "(1) predict; or (2) warn or take precautions to protect from: a patient's violent behavior unless the patient has communicated to the provider of mental health services an actual threat of physical violence or other means of harm against a reasonably identifiable victim or victims ... .''192 187. u.s. census bureau, u.s. dep't of commerce, households and families: 2000, available at http://factfinder.census.gov/servlet/qtiable? _ bm=y&-geo _ id=o 1 ooous&­ qr_name=dec_2000_sfl_u_qtp10&-ds_name=dec_2000_sfl_u&-_lang=en&­ redolog=false&-_sse=on (last visited mar. 9, 2005). 188. u.s. census bureau, marital status by sex, unmarried-partner households, and grandparents as caregivers: 2000, available at http://factfinder.census.gov/servlet/qtiable? _ bm=y&-geo _id=o 1 ooous&-qr_name=dec _2000 _sf3 _ u _ qtp 18&-ds_name=dec_ 2000_sf3_u&-_lang=en&-redolog=false&-_sse=on (last visited on mar. 9, 2005). 189. greg barrett, in gay households, familiar endearments acquire new meaning, gannett news serv., apr. 11, 2004, http://www.azcentral.com/families/articles/ 0411gayparent11-cr.html (last visited mar. 9, 2005). 190. u.s. census bureau, marital status by sex, unmarried-partner households, and grandparents as caregivers: 2000, available at http://factfinder.census.gov/servlet/qtiable? _ bm=y&-geo_id=01000us&-qr_name=dec_2000_sf3_u_qtp18&-ds_name= dec_2000_sf3_u&-_1ang=en&-redolog=false&-_sse=on (last visited on mar. 9, 2005). 191. la. rev. stat. ann.§ 9:2800.2(a) (2004) (emphasis added). 192. ind. code § 34-30-16-1 (west 2005) (emphasis added). 198 indiana health law review [vol. 3:171 furthermore, a colorado statute states that no mental health professional or mental health hospital is civilly liable for failing to "warn or protect any person against a mental health patient's violent behavior ... except where the patient has communicated to the mental health care provider a serious threat of imminent physical violence against a specific person or persons."193 in pennsylvania, a psychotherapist has a duty-to-warn "or an obligation to use reasonable care to protect the intended victim against such danger. the psychotherapist does not violate the psychotherapist-patient privilege when disclosing such patient communications ."194 in these instances, the communi­ cation that is protected and that triggers the dangerous person exception is when the information is communicated by the patient and not by the patient's agent or anyone else, including the patient's family member. additionally, the·supreme court of pennsylvania found, when it frrst recognized the mental health professional's duty-to-warn, "that the circum­ stances in which a duty to warn a third party arises are extremely limited."195 the court proposed a two prong test to determine when a limited duty-to-warn requirement should be imposed. first, whether there was a specific and immediate threat and, second, whether the victim was readily identifiable. 196 the court recognized that a psychotherapist's treatment of a patient can produce ''vague and imprecise threats ... made by an agitated patient as a routine part of the relationship. "197 dr. goldstein did not have the opportunity to determine whether geno's threat was vague and imprecise or to observe geno 's level of agitation when he made the threat because geno never communicated the threat to dr. goldstein. the emerich court also stated "{s]trong reasons support the determination that the duty to warn must have some limits. "198 dr. goldstein used his common sense when he told victor to take geno to the hospital. the california court should have followed the same reasoning as the emerich court by taking notice that dr. goldstein did use his prior analysis of geno and common sense and that only in the instance had the threat come directly from geno did dr. goldstein have a duty-to-warn keith ewing. even the california statute explicitly says ''patient" communication. 199 a psycho­ therapist may, in some instances, need to rely on information received from a patient's family member to facilitate a patient's care, but to impose a duty 193. colo. rev. stat.ann. § 13-21-117 (west 2005) (emphasis added). 194. university of pennsylvania health system. a guide to legal issues in health care: confidentiality, available at http://www.uphs.upenn.edullegallconfid.html (last visited aug. 7, 2005) (emphasis added). 195. emerich v. philadelphia ctr. for human dev.,lnc., 720 a2d 1032, 1040 (pa. 1998) (emphasis added). 196. /d (emphasis added). 197. /d. 198. /d. (emphasis added). 199. cal. civ. code§ 43.92(a) (west 2005). 2006] duty tow arn-even if it may be hearsay? 199 upon the psychotherapist to warn an intended victim based on information received from family members goes beyond the limits of care. on the other hand, the ewing court put no limits on the duty of a psychotherapist to warn an intended victim of harm. the court could have followed the reasoning in preserving the psychotherapist-patient privilege similar to the pennsylvania court. the emerich court used the words "extremely limited' when discussing whether or not to allow an exception to this well protected privilege. 200 instead, the ewing court indicated that it "does not matter'' that the psychotherapist's belief or prediction of harm was premised on information from a member of the patient's family.201 however, the court noted it does matter if the belief was premised on information from someone other than a family member. apparently; the distinction is significant. by saying, in a footnote, that this case applies only to family members opens the door to other causes of action based on information from a person who may not fit the legal definition of "family member." thus, each case would be limited to an analysis of the status of the individual as a family member. the slippery slope is going to start with the next victim and wrongful death suit; when the next victim dies. because they were not warned by a psychotherapist from information provided by someone other than the patient; or when the next case is brought before the california courts claiming that someone's aunt, distant relative or friend should be considered an immediate family member and a doctor or hospital is liable for the death. both taraso.ff decisions have had significant impact on most states and federal courts, especially in california. 202 the ewing cases will likely have a similar impact. to date, fifty-one cases have followed tarasoffll and an additional twenty­ five cases have had concurring opinions using tarasoff ii to recognize the duty-to-warn requirement. the california court of appeals would probably not agree that it bas broadened the statute or may have created a slippery slope, but look at the impact that just the tarasoff cases have had on the american court system as well as the impact from broadening a well regarded and protected psychotherapist-patient privilege. the effect and fallout can be astronomical. v. conclusion privileges are not taken lightly in the courts. the united states supreme court bas stated that"[ e ]videntiary privileges in litigation are not favored,"203 200. emerich, 720 a.2d at 1040. 201. northridge hosp., 16 cal. rptr. 3d at 596 (cal. ct. app. 2004). 202. tarasoff i has been cited in fifty-nine law review articles, one statute and twelve treatises while the tarasoff ii decision has been cited in 762 law review articles, two restatements, five statutes, 128 treatises and eleven american law reports. 203. herbert v. lando, 441 u.s. 153, 175 (1979). 200 indiana health law review [vol. 3:171 and"[ w ]hatever their origins, these exceptions to the demand for every man's evidence are not lightly created nor expansively construed for they are in derogation of the search for truth. "204 the goldstein court has expansively construed, and has lightly created the psychotherapist-patient privilege when it found that the family member's communication with the therapist must be protected. by protecting the non-patient communication, the ewing courts, in turn, have provided a level of confidentiality to the family member. there must be a privilege before one can invoke the dangerous person exception, and the goldstein court extended this protection when it expanded the psychotherapist-patient privilege by protecting non-patient communications and imposing the duty-to-warn on the psychotherapist. a patient's privileged relationship with a physician or psychotherapist are to be highly regarded. patients need to be protected, and any and all exceptions should be very limited. the sixth circuit court of appeals stated that the psychiatric patient "exposes . . . not only what his words directly express; he lays bare his entire self, his dreams, his fantasies, his sins, and his shame."20s the court furthered that "[ijt would be too much to expect them to do so if they knew that all they say-and all that the psychiatrist learns from what they say-may be revealed to the whole world from a witness stand. "206 psychotherapists should be encouraged to use their professional judgment in determining whether information about the threat a patient poses is information that would require breaking the highly regarded confidence and privilege that courts have been very careful to create. however, allowing the use of information obtained from someone that is not privy to that confidence and privilege is wrong. nonetheless, there are greater consequences when a court imposes a duty-to-warn on a psychotherapist and any hospital staff when threatening information has been obtained from a non-patient, non-privilege protected "immediate family member." 204. united states v. nixon, 418 u.s. 683,710 (1974) (emphasis added). 205. zuniga, 714 f.2d at 638. (quoting taylor v. united states, 222 f.2d 398,401 (d.c. cir. 1955)). 206. !d. live or let die: will the courts recognize in terminally ill patients a fundamental right to choose non-fda approved drugs or does the fda's stringent approval process carry sufficient merit? clayton r. portell• table of contents i. introduction ..................................................................................... 124 ll. thefdaandits stringent approvalprocess ........................... 126 a. drug regulation is no new concept ........................................ 126 b. history of the food and drug administration .......................... 121 c. the fda 's current drug approval process ............................. 128 ill. the abigail whirlwind .................................................................. 131 a. a brief setting for the case ....................................................... 131 b. a glimpseofhope .................................................................... 131 c. hope denied? ........................................................................... 134 d. hope for a better tomorrow? .................................................. 136 n. should the terminally ill be allowed to choose? ............... 137 a. considerations in favor of deregulation ................................. 137 b. considerations against deregulation ....................................... 140 c. legal concerns regarding deregulation versus the right of terminally ill patients to choose non-fda approved drugs .................................................................... ~·· 143 v. the future of the fda's approval process regarding terminally ill patieni's' access to unapproved drugs .... 145 a. a preemptive strike? ................................................................. 145 b. legislative action ...................................................................... 145 c. drug regulation around the world .......................................... 149 i. great britain ....................................................................... 149 2. germany .............................................................................. 150 3. world health organization ................................................. 151 d. privatization as an alternative ................................................. 151 vi. conclusion ....................................................................................... 152 • j.d. candidate, 2008, indiana university school of lawindianapolis; b.a., 2005, southeast missouri state university, cape girardeau, missouri. i would like to thank the edi­ tors and staff of the indiana health law review for all of their help along the way. special appreciation also goes to my wife starla and my parents for their love, support, and encourage­ ment. 124 indiana heal til law review [vol. 5:123 i. introduction taking into account the number of patients who have died without access to potentially life-saving drugs, the current state of drug approval in the united states is in need of change. to what extent the current regulatory system should be changed has become a highly controversial and debated topic throughout the nation. with strong arguments on both sides of the issue, one thing remains evident: too many patients have suffered through their last days with little or no hope. appropriate adjustments to the food and drug admini­ stration's ("fda") regulatory structure could deliver that much deserved and long awaited hope. it is estimated that, in 2006, nearly 1.4 million ''terminally ill''1 patients in the united states lost their battle, many having been denied access to poten­ tially lifesaving treatments.2 while there are hundreds of drugs manufactured every year, many of them will not make it to the very patients whom they were designed to protect until it is too late. this is because there is a lengthy ap­ proval process that has been established by the fda. in fact, over the last five years, the fda's average approval rate for new drugs is just twenty-three a year. 3 the united states is recognized as having one of the most regulated and demanding drug approval systems in the world.4 the result of this elaborate system is that many patients, despite the fact that they face imminent death, are denied the chance to prolong or even save their lives. over the past two decades, there has been much criticism aimed at the fda's current drug approval system. this criticism has been the topic of nu­ merous articles, notes, and even court decisions. until recently, however, the government has stood behind the fda's conservative approach and its reason­ ing for initially establishing the debated process. while the integrity of the sys­ tem, one which often comes between near-death patients and the hope of a potential cure, has frequently been called into question, the fda has repeatedly been held to be the paramount authority on the issue. the tenure of the fda's supreme authority may, however, soon come to an end. on may 2, 2006, the united states court of appeals for the district of columbia circuit rendered a decision that sent shockwaves through the medical community.5 in abigail alliance for better access to developmental drogs v. 1. ''tenninally ill" refers to a person, suffering from a disease, who is not expected to live more than 12 months. see dictionary.com, http://dictionary.reference.com/browse/ terminally4'/o20ill (last visited feb. 27, 2008). 2. see generally cancer facts and figures 2006, issue rep. (am. cancer soc'y, okla. city, okla.), 2006, at 1-56, available at http:llwww.cancer.org/downloads/sti/ caff2006pwsecured.pdf. 3. jerome groopman, the right to a trial: should dying patients have access to ex­ perimental drugs?, the new yorker, dec. 18,2006, at40. 4. john patrick dillman, note, prescription drug approval and terminal diseases: desperate times require desperate measures, 44 v and. l. rev. 925, 927 (1991 ). 5. abigail alliance v. eschenbach, 445 f.3d 470 (d.c. cir. 2006), vacated, 495 f.3d 2008] live or let die 125 eschenbach, a three judge panel of the court ruled, in a two to one decision, that terminally ill patients have a fundamental right to drugs that have not been fully approved by the fda.6 for the next couple of months the extent of the decision became the topic of debate in the media and medical community as numerous concerns arose. flurries of questions were posed, such as: how much regulation was necessary before access would be permitted? who exactly would be permitted access to unapproved drugs? would the decision of the u.s. court of appeals for the district of columbia survive before the supreme court if the fda were to appeal? recognizing the serious implications of its decision, the u.s. court of appeals for the district of columbia, on november 21, 2006, decided to vacate its previous decision and to conduct a rehearing. on august 7, 2007, the court reversed its previous decision and held that pa­ tients do not have a fundamental right to experimental drugs.7 while the deci­ sion struck a blow to cancer patients and advocacy groups around the nation, it is expected that the case will reach the united state supreme court within the next couple of years. while it is uncertain how the supreme court will decide the issue, it is evident that there exist both ethical dilemmas and legal concerns regarding the rights of dying patients. this note will concentrate on terminally ill cancer pa­ tients and their access to experimental drugs that have not been approved by the fda.8 because of the unique nature of terminal diseases, the fda's conserva­ tive approval process raises even greater concerns. the fda requires that new drugs pass three phases oftesting before being introduced on the market.9 such extensive testing takes, on average, nearly seven years to complete.10 however, terminally ill patients, by defmition, usually have less than one year to live. 11 it is obvious that, under current regulations, newly manufactured drugs and re­ cently discovered treatments will often not be available to such terminally ill patients until it is too late. the fda is not, however, apathetic to the lives and needs of terminally ill patients. rather, it was established to serve as a gatekeeper and to protect the health of the nation, including those very patients it is allegedly harming.12 the fda requires such extensive testing for new drugs so that it can screen for po­ tential risks, including side-effects and poisons. 13 if patients were granted free 695 (2007). 6. !d. at 486. 7. see abigail alliance v. eschenbach, 495 f.3d 695 (d.c. cir. 2007). 8. it should, however, be recognized that there are other groups of terminally ill patients, such as those with aids and cardiovascular diseases. see pressure for new us fda experi­ mental drug regulations could create problems, pharmamarketleiter, dec. 25, 2006 §§ 1355-8501. 9. see fda investigational new drug application rule, 21 c.f.r. § 312.21 (2007); see also infra, part ii.b. 10. abigail alliance v. eschenbach, 445 f.3d 470, 474 (d.c. cir. 2006). 11. dictionary.com, supra note 1. 12. lisa casanova. the terminally ill and their right to drugs, mises insrrrute, july 24, 2006, http://www.mises.org./story/2245 (last visited feb. 27, 2008). 13. !d. 126 indiana health law review [vol. 5:123 access to every new treatment and drug before testing was complete, there is a significant potential that the illness could be worsened or that the drugs could have a lethal effect. for these reasons. the fda has taken the conservative ap­ proach and required intense testing before releasing new drugs. nevertheless, the fda has recently taken steps to speed the process and allow for alternative testing methods.14 part ii of this note surveys the history of the fda and its prescription drug approval process. part m discusses abigail alliance and the potential recognition of a fundamental right in terminally ill patients. part iv analyzes the ethical dilemma and legal implications involved in the issue. finally, part v of this note addresses future concerns regarding tenninally ill patients' ac­ cess to new drugs, and proposes modest changes to the current drug approval process. this note will conclude with a short summary and one law student's take on the drug industry and the idea of deregulating the food and drug ad­ ministration's current approval process. ii. the fda and its stringent approval process a. drug regulation is no new concept since nearly the dawn of mankind, there have been regulators of drug and treatment usage. in ancient egypt, physicians were required to practice in ac­ cord with written laws.15 also, during medieval times in muslim countries, a group known as the muhtasib made inspections and supervised the production of medicine.16 in europe, between the eleventh and twelfth centuries, laws were passed forbidding doctors from keeping and using certain medicines and utilizing the services of certain apothecaries.17 then, the united kingdom, in 1540, passed the apothecary wares, drugs, and stuffs act; thereby, empower­ ing physicians to inspect the premises of apothecaries for certain ineffective drugs.18 interestingly enough, however, the united states was without official drug regulation for over a century after its birth. in fact, the first passage of laws relating to the regulation of pharmaceutical drugs and treatments did not occur until the beginning of the twentieth century. 14. see infra part v.a. 15. eshetu wondemagegnebu, effective drug regulation: what can countries do?, theme paper (world health org.,geniva. switz.), mar. 1999, at s[bereinafter who], available at http:// www.wbo.int/medicinedocs/couect/edmweb/pdf/s2216e/s2216e.pdf. 16. id. 17. id. 18. ld. 2008] live or let die 127 b. history of the food and drug administration in 1906, congress enacted the pure food and drugs act ("1906 act"). prior to that time, there was very little national regulation of medicinal drugs in the united states. 19 the 1906 act banned the manufacture and distribution of tainted food and drugs and prohibited misleading labeling of the same.20 ''the 1906 act did not, however, limit individual access to new drugs or regulate therapeutic claims by drug manufacturers. "21 thus, a patient could still, as had been the case since the foundation of the united states government, obtain ac­ cess to any new medicinal drug, so long as doing so was not a narcotics viola­ tion. 22 though not particularly effective, the 1906 act remained the standard for three decades. in 1937, public outcry erupted after more than a hundred people died from ingesting elixir sulfanilamide, a drug which had not been tested for safety. 23 in 1938, the government responded by passing the food drug & cosmetic act ("fdca")?4 this act required, "[t]or the first time ... that drug manufactur­ ers test, and the fda review, all new drugs for safety.'.25 a manufacturer was now required to file a new drug application (''nda'') with the fda, setting forth a drug's safety information, before introducing it to the market.26 the act, however, still did not require affirmative approval from the fda; thus, a drug could be distributed unless the fda barred its distribution?' further­ more, existing drugs were immune from the new rules because the fdca con­ tained a grandfather clause exempting existing drugs that were subject to the 1906 act. 28 therefore, the pharmaceutical market was still contaminated with drugs that had not been tested for safety. the most significant change to the fdca occurred in 1962 when con­ gress passed the kefauver-harris amendments.29 the amendments arose in response to the discovery that thalidomide, a drug used to relieve morning sick­ ness in pregnant women, caused substantial birth defects. 30 the 1962 amend­ ments introduced substantial changes to the way the fda operated its approval 19. abigail alliance v. eschenbach, 445 f.3d 470,474 (d.c. cir. 2006). 20. charles j. walsh & alissa pyrich, rationalizing the regulation of prescription drugs and medical devices: perspectives on private certification and tort reform, 48 rutgers l. rev. 883, 890 (1996). 21. abigail alliance, 445 f.3d at 481. 22. !d. at 482. 23. walsh & pyrich, supra note 20, at 893. 24. see 21 u.s.c §§ 301-399(a) (2007). 25. abigail alliance, 445 f.3d at 482. 26. id. 27. id. 28. walsh & pyrich, supra note 20, at 894. 29. id. at 896. 30. !d. see also dillman, supra note 4, at 925 n.2 (explaining that "[i]ronically, because thalidomide caused dramatic side effects in a relatively small class of patients, the true defect may have resulted from a labeling, and not a testing, tailure. "). 128 indiana health law review [vol. 5:123 process. first, they required the fda to ensure, not only that new drugs were safe, but also that they were effective for their intended purposes.31 further­ more, ''the amendments authorized the fda to approve human clinical trials, regulate drug advertising, inspect drug-manufacturing facilities, and promulgate good manufacturing practices."32 today's drug approval process is based on the standards set forth in the fdca and the 1962 amendments. general counsel for the fda has identified five goals that it strives to meet in each decision and process. 33 those goals are: (1) to protect the public from harm through product regulatory mechanisms;34 (2) to maximize individ­ ual autonomy;35 (3) to guarantee public participation in the decision-making process;36 (4) to ensure that procedures are consistent and dependable;37 and (5) to swiftly render decision upon pending issues.38 whether or not the fda's current approval process serves each of these goals has sparked debate and cre­ ated doubt about the agency's methods. c. the fda's cun-ent drog approval process the fdca defines drugs as "articles (other than food) intended to affect the structure or any function of the body of man" and "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."39 in order to keep adulterated drugs from the public's reach, the fda requires substantial evidence of safety and efficacy for any "new drug'"'0 before it can be introduced into interstate commerce.41 "the term 'substantial evi­ dence' does not mean what it means elsewhere in administrative law, namely, 'such relevant evidence as a reasonable mind might accept as adequate to sup­ port a conclusion. "'42 instead, its meaning is derived from purely scientific functions.43 in order to implement such precision, the fda has created a strin­ gent approval process, leaving no room for questionable drugs. 31. walsh & pyrich, supra note 20, at 897. 32. abigail alliance v. eschenbach, 445 f.3d 470, 482 (d.c. cir. 2006). 33. peter barton hutt, food and drug regulation in transition, 35 food drug cosm. l.j. 283, 287-90 (1980). 34, id. at 288. 35. ld. at 289. 36. id. 37. id. 38. id. at 290. 39. 21 u.s.c. § 32i(gx1) (2007). 40. a "new drug" is defined as a drug not "generally recognized, among experts ... as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." 21 u.s. c.§ 32l(px1x2000); see also united states v. 50 boxes more or less, 909 · f.2d 24, 25 (1st cir. 1990). 41. 21 u.s.c. § 355(a) (2007). 42. 50 boxes more or less, 909 f.2d at 26 (citing universal camera cotp. v. nlrb. 340 u.s. 474 (1951) (quoting consolidated edison co. v. nlrb, 305 u.s. 197,229 (1938))). 43. · "substantial evidence" means "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts." 21 u.s.c. § 355(d) (2007). 2008] live or let die 129 before the fda will accept a nda, the drug must pass three phases of human clinical testing.44 the drug must, however, first complete pre-clinical animal testing before it will even be considered for the first approval phase.45 once the drug has completed appropriate pre-clinical testing, its "manufacturer must apply to the fda for an investigational new drug ("ind") exemption.'.46 if the ind exemption is granted, the drug may commence the fda approval process. during the process, the fda reserves the right to halt testing at any phase if it is not satisfied with the drug's safety and effectiveness.47 in phase i, an ind is introduced "into a small group ofhealthy human vo­ lunteers for a short period of time. ,.43 phase i consists of approximately one year of testing, on twenty to eighty human subjects.49 scientists review for any side effects associated with increased dosages and for the preliminary effective­ ness of the drug. 5° fda counsel has acknowledged ''that drugs that survive this phase have been deemed 'sufficiently safe for substantial human testing, but [are] not yet proven to be safe and effective to the satisfaction of the fda [to be commercially marketed]. "'51 however, "[ n ]early ninety per cent of drugs that enter phase i trials are eventually abandoned because they are shown to be un­ safe or ineffective."52 phase ii begins a more complete review of efficacy. it involves "con­ trolled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition un­ der study .... "53 while the population of phase ii testing is larger than the population of phase i testing, "drug sponsors still do not include a large number of patients in these trials. ,.54 the average time for phase ii testing is eighteen months. 55 finally, phase ill trials are "intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk i d. 44. 21 c.f.r. § 312.21 (2007). 45. walsh & pyrich, supra note 20, at 904. 46. id. at 905. 47. ld. at 906. 48. dillman, supra note 4, at 928. 49. walsh & pyrich, supra note 20, at 906. 50. fda investigational new drug application rule, 21 c.f.r. § 312.21(ax1) (2007) phase i includes the initial introduction of an investigational new drug into humans. phase i studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. these studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness. 51. abigail alliance for better access to developmental drugs v. eschenbach, 445 f.3d 470,473 (d.c. cir. 2006) (quoting oral argument tape of oct. 21,2005 at 15:57-15:59). 52. groopman, supra note 3. 53. fda investigational new drug application rule, 21 c.f.r. § 312.21(b) (2007). 54. dillman, supra note 4, at 929. 55. walsh & pyrich, supra note 20, at 907. 130 indiana health law review [vol. 5:123 relationship of the drug and to provide an adequate basis for physician label­ ing. "56 phase ill trials can include seveml thousand human subjects and last, on average, about three years. 57 it can take an lnd up to twelve years to complete all of the required test­ ing necessary to assure safety and effectiveness. 58 approval is not, however, freely given once the phases are complete. after an lnd has satisfied the fda with completion of the three phase approval process, the manufacturer must then apply for a nda, which is an "exhaustive application, containing nearly every piece of information collected about the drug in the course of laboratory and animal testing as well as in clinical trials. "59 after a comprehensive review of the application, usually lasting three years. the fda will then decide whether to give approval, or to send the drug back for modifications or further testing. 60 overall, approximately seventy percent of new experimental drugs proceed from phase i to phase ll, and only about thirty~three percent reach phase ill. 61 of those drugs that reach phase ill testing, only twenty-five to thirty percent will successfully complete the phase, and about twenty percent will be ap­ proved for the market. 62 the fda's approval system is exhaustive, extensive, exacting, and ex­ pensive. while it can frustrate manufacturers and delay the production of promising drugs, it also protects the public from hazardous products and deters frivolous attempts to enter the drug market. if not for the fda's creation of its stringent three-phase process, many more dangerous drugs like elixir sulfa­ nilamide and thalidomide, might have entered the u.s. market. the fda is not, however, without its critics. there are a growing number of advocates and lobbyists who are fighting, without regard to cost, to deregulate the drug ap­ proval system and allow for easier introduction of and access too new drugs. while the fda has historically been backed by the government; thereby, main­ taining the upper hand in the battle, it appears that the tide of battle may be on the verge of turning. 56. fda investigational new drug application rule, 21 c.f.r. § 312.21 (c) (2007). 57. walsh & pyrich, supra note 20, at 907. 58. id. at 933. 59. ld. at 907-908 (citing fda investigational new drug application rule, 21 c.f .r. § 312.21 (2007)). 60. id. at § 909-11. 61. marsha n. cohen, getting new drugs to people with aids: a public policy re­ sponse to lansdale, 18 hastings const. l.q. 471, 474 n.13 (1991). 62. ld. 2008] live or let dm 131 ffi. the abigail whirlwind a. a briefseningfor the case on january 16, 2003, the abigail alliance, an advocate group for the ter­ minally ill, submitted a proposal to the fda asking that post-phase i inds be made available to terminally ill patients who were not admitted to the fda's clinical trials.63 after the fda denied the alliance's proposal and ignored its citizen petition, the alliance filed suit against the fda commissioner, andrew c. von eschenbach, m.d., and the secretary of the department of health and human services, michael 0. leavitt.64 the alliance's suit sought to "enjoin the fda from enforcing the policy barring the sale of post-phase i investiga­ tional new drugs to terminally ill patients not in phase n clinical trials.'o65 upon review, the district court dismissed the alliance's complaint pur­ suant to a federal rule of civil procedure 12(b x 6)66 motion to dismiss for fail­ ure to state a claim upon which relief can be granted. 67 the court concluded that the challenged fda policy was rationally related to a legitimate govern­ ment purpose. 68 thereafter, the alliance appealed to the united states court of appeals for the district of columbia, which rendered a decision that not only gave hope to thousands of terminally ill patients, but also caused a significant stir in the media and medical community. b. a glimpseofhope after reviewing party briefs and hearing oral arguments, an en ban~el (the "panel") of the circuit court rendered its decision on may 2, 2006. in a 2-1 decision, a new fundamental right was recognized, granting terminally ill patients access to post phase i drugs and treatment when no other alternatives exist 70 knowing that there was little precedent on the subject, and that such a decision would be the subject of much criticism, the court turned to the consti­ tution for authority to recognize this right. the due process clause of the fifth amendment of the united states constitution states, in pertinent part, that "(n]o person shall be ... deprived of life, liberty, or property, without due process oflaw.'.n a constitutional right, falling under such a clause, is generally recognized as a fundamental right the 63. abigail alliance v. eschenbach, 445 f.3d 470, 473 (d.c. cir. 2006). 64. id. at 473-74. 65. !d. at 474. 66. fed. r. civ. p. 12(b)(6). 67. abigail alliance, 445 f.3d at 474. 68. id. at 475. 69. id. at 470. 70. ld. at 486. 71. u.s. const. amend. v (emphasis added). 132 indiana heal til law review [vol. 5:123 panel turned to the supreme court for guidance in examining an asserted fun­ damental right. the issue was examined in washington v. glucksberg.72 it noted that a court must consider "whether the fundamental right asserted is objectively 'deeply rooted in this nation's history and tradition,' and 'implicit in the concept of ordered liberty, such that neither liberty nor justice would ex­ ist if it were sacrificed. "'73 when such a right is found, if the government can­ not prove a compelling interest in retaining control over the specific area, applicable citizens will assume the right 74 there are two components of the glucksberg analysis. the first compo­ nent requires courts to compose a "careful description" of the asserted funda­ mental liberty interest at stake.75 the description must not be too broad, or contain a greater population or a greater liberty interest than what is actually recognized by the right. rather, the description must be narrowly tailored to the "most specific level at which a relevant tradition protecting, or denying pro­ tection to, the asserted right can be identified."76 applying these guidelines, the panel found that the alliance's complaint contained such a careful description.77 the alliance's claim did not state an overly broad right of access to all new or investigational new drugs; nor, did it claim a right to receive treatment at the government's expense. 78 further, the claim did not violate or challenge the controlled substances act. 79 instead, "the alliance contends that the fundamental due process rights to privacy, lib­ erty, and life include the right of terminally ill patients, acting on a doctor's ad­ vice, to obtain potentially life-saving medication when no alternative treatment approved by the government is available.'.so this description was found by the panel to be careful enough to meet the "careful description" requirement of the glucksberg test. it held that the claimed right was narrowly tailored to termi­ nally ill patients and applied only in situations when their medication is poten­ tially life-saving and no alternatives exist. 81 further, the right only applied to 72. washington v. glucksberg, 521 u.s. 702, 702 (1997) (holding that there existed no fundamental right to commit suicide or to assistance in doing so, and that state's ban on as­ sisted-suicide was rationally related to legitimate government interests). 73. abigail alliance, 445 f.3d at 476-77 (quoting glucksberg, 521 u.s. at 721 (internal quotation marks omitted)). 74. ld. at 477. 75. glucksberg, 521 u.s. at 721. 76. abigail alliance, 445 f.3d at 477 (quoting michael it v. gerald d., 491 u.s. 110, 127 (1989)). 77. id. at 478. 78. ld. 79. 21 u.s.c. §§ 801-961 (2000). the statute regulates substances that are considered harmful to the public's health, safety, and welfare. if the alliance's claim called for the use of narcotics, such as marijuana, it would be repugnant to existing federal law and, therefore, inva­ lid. 80. abigail alliance, 445 f.3d at 478. 81. ld. at486. 2008] live or let die 133 drugs which had completed phase i of the fda's approval process~ thereby, reducing the chance of unknown risks. 82 the second component of the glucksberg test requires courts to inquire whether there is a long-standing tradition in the united states that protects the asserted right. 83 in response, the fda argued that it has had statutory authority to regulate drugs for nearly a hundred years, and that such authority was in­ grained in the role of the government.84 the panel, however, was not per­ suaded that the fda's authority was so deeply rooted in our nation's history as to constitute a long-standing tradition. instead, the panel found a different tra­ dition, one which supported the alliance's claim. specifically, the panel asserted that "[a] right of control over one's body has deep roots in the common law" including '"a person's legal and uninter­ rupted enjoyment of his life, his limbs, his body, [and] his health,' as well as 'the preservation of a man's health from such practices as may prejudice or an­ noy it. "'85 also recognized in american history is the defense of necessity, or the right of self-preservation, which allow for extreme measures, not ordinarily justified, when a person is faced with death. 86 the defense of necessity allows for the destruction of property, including that of another's, if it is necessary to preserve human life.87 the fda's regulation ofpotentially life-saving treat­ ment impinges on this right of self-preservation. 88 furthermore, while the common law does not impose a duty to rescue or to preserve the life of another, it does create liability for interfering with such rights. 89 finally, the panel looked to similar due process caselaw governing a per­ son's fundamental right to self-autonomy. in cruzan v. director, missouri dept. of health, the supreme court explained that a person has a fundamental right to refuse life-sustaining treatment.90 there, the supreme court stated that "[ n ]o right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and un­ questionable authority oflaw .'m in abigail alliance, the panel found the su­ preme court's reasoning to be similarly applicable to the issue of drug access, 82. !d. at 478. 83. ld. at 479. 84. /d. at 480. 85. !d. (quoting william blackstone, 1 commentaries 125, 130 (1765)). 86. ld. 87. see george c. christie, the defense of necessity considered from the legal and moral points of view, 48 dukel.j. 975, 988(1999). professor christie discusses aline of cases in english and american history which have allowed for the destruction of property, including ships, docks, and land, when it would have otherwise resulted in the loss of human life. the most significant aspect of this defense in today's legal system can be seen in admiralty law which allows for ships to dump cargo, including oil, in life-threatening situations. !d. at 984-89. 88. abigail alliance, 445 f.3d at 480. 89. !d. (citing restatement(first)oftorts § 326 (1934)). 90. cruzan v. dir., mo. dep't. of health, 497 u.s. 261, 277 (1990). 91. /d. at 269 (quoting union pac. ry. co. v. botsford, 141 u.s. 250, 251 (1891)). 134 indiana health law review [vol. 5:123 explaining that an individual must also be free to decide whether to assume any risks of taking a medication which might prolong his or her life. 92 if a person is allowed to decline potentially life-saving assistance because of the concept of self-preservation, then a person should also be able to have access to potentially life-saving assistance for the same reason. furthermore, although there have been a few cases that have rejected a terminally ill patient's right to drugs, those cases involved medication which had not completed phase i testing, thereby increasing possible risks and, likewise, the government's compelling interest.93 it was for such reasons that the panel found a fundamental right to exist and rendered its decision. it held that "where there are no alternative gov­ ernment-approved treatment options, a terminally ill, mentally competent adult patient's informed access to potentially life-saving investigational new drugs determined by the fda after phase i trials to be sufficiently safe for expanded human trials warrants protection under the due process clause."94 the holding seemed to open the doorway for terminally ill patients to finally have access to treatment which had been withheld from them for so long. c. hope denied? the abigail alliance decision soon caught the attention of much of the media, as it is seldom that a court oflaw finds a new fundamental right that has not yet been realized. also, the element of emotion that exists with regard to terminally ill patients led to even greater publicity. the fda, however, did not easily relinquish the regulations that it had established and enforced for nearly half a century. the fda immediately appealed the decision and, because of the striking implications of the abigail alliance holding, the appeals court vacated the holding on november 21, 2006.95 on august 7, 2007, after rehearing argu­ ments, the full bench of the d.c. circuit court rendered an eight to two deci­ sion, holding that terminally ill patients have no fundamental right to access drugs which have not been approved by the fda.96 the majority of the panel, which had previously held that terminally ill patients did have a fundamental right to access drugs pending approval by the fda, this time joined in a dis­ senting opinion, arguing that a right to access did exist. 97 the circuit court turned to the glucbber.gtest,just as the panel had, but this time found that the claimed right to access failed to meet the test's re­ quirements. 98 assuming arguendo that the asserted right to access satisfied 92. abigail alliance, 445 f.3d at 484. 93. /d. at 485-86 (citing camohan v. united states, 616 f.2d 1120 (9th cir. 1980) and rutherford v. united states, 616 f.2d 455 (loth cir. 1980)). 94. /d. at 486. 95. federal appeals court to consider access issues. am. healmline, nov. 27,2006. 96. abigail alliance v. eschenbach, 495 f.3d 695, 713 (d.c. cir. 2007). 97. /d. at 714. 98. /d. at 703-o7. 2008] live or let die 135 glucksberg 's "careful description" requirement, the court held that it still failed to satisfy the second requirement of the test, that the right be deeply rooted in this nation's history, tradition, and practices.99 moreover, it concluded that the issue is not merely whether there is a tradition of access to drugs that have not· been proven effective, as argued by abigail alliance, but also whether there is a "tradition of access to drugs that have not yet been proven safe. "100 in reviewing the history of our nation's drug regulation, going back as far as the colonies and early acts passed by state legislatures, the court found that the drug regulation is well-rooted in our nation's history.101 furthermore, it held that even though there was little. drug regulation prior to the 1962 amendments102, "an arguably limited history of efficacy regulation prior to 1962 does not establish a fundamental right of access to unproven drugs."103 additionally, the court reasoned that the stream of amendments made to the fdca throughout the twentieth century exhibited a continuous response by congress to new risks presented by evolving technology.104 the court further explained that a lack of government interference throughout history does not alone prove that an asserted right is deeply rooted.105 it reasoned that if such reasoning were allowed, then there could be a swarm of claims for fundamental rights merely because such ''rights" were not regulated until recent times. examples include marijuana use, which was not regulated untill937, and ~eed limits, which were obviously unnecessary prior to the twentieth century.1 ultimately, the court concluded that "[t]he lack of prior governmental regulation of an activity tells us little about whether the ac­ tivity merits constitutional protection. "107 thus, the alliance's arguments con­ cerning of lack of regulation failed to persuade the court. finally, the court examined the common law arguments posed by abigail alliance, which the panel used to justify its finding of a fundamental right firm­ ly rooted in our nation's history. the court first dealt with abigail alliance's argument of necessity, which covers situations "where physical forces beyond the actor's control rendered illegal conduct the lesser of two evils. "108 in unit­ ed states v. oakland cannabis buyers' cooperative, the supreme court re­ jected an argument that marijuana for medicinal purposes was a medical necessity.109 it held that the defense of necessity "cannot succeed when the leg99. id. at 702-03. 100. id. at 703. 101. id. at 703-05. 102. see supra part id.b. 103. abigail alliance, 495 f.3d at 706. 104. id. 105. id. 106. id. at 707. 107. ld. 108. id. at 707 (quoting united states v. oakland cannabis buyers' coop., 532 u.s. 483, 490 (2001)). 109. abigail alliance, 495 f .3d at 708. 136 indiana healtii law review [vol. 5:123 islature itself has made a detennination of values. "110 applying that holding to abigail alliance, the circuit court held that, because congress has prohibited general access to non-approved drugs, a defense of necessity cannot take prece­ dent over such a detennination.111 the court then quickly disposed of the arguments of self-defense and in­ tentional interference with lifesaving efforts raised in abigail alliance, as both defenses are based on aid that is necessary to the preservation of life.112 the experimental drugs for which access is being sought have not been proven safe or effective, and are, therefore, only potentially lifesaving.113 indeed, because of the risks involved, the drugs cannot be considered a necessary aid; thereby, failing to meet the standard for both defenses.114 finding that the asserted right did not meet the minimum requirements for a fundamental right, the circuit court next applied the rational basis scrutiny test.115 the rational basis test requires that a government restriction or regula­ tion merely bear some rational relationship to a legitimate state interest 116 here, the state interest is protecting patients from the dangers and risks posed by a drug that has not been through the fda's approval process.117 the court explained that "the government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug."118 in holding that tenninally ill patients do not have a right to non-approved drugs, the court advised that the matter was best left to the democratic braches for a determination of the proper balance between the risks and benefits posed by such drugs.119 d. hope for a better tomorrow? abigail alliance v. von eschenbach is expected to reach the united states supreme court within the next couple of years. the supreme court is in a bet­ ter position to consider the constitutional implications involved in the possibil­ ity of a fundamental right. also, the case is a sensitive subject between the historical authority of the fda and the free will of man to make his own deci­ sion regarding his chance of survival. given that the supreme court might consider the issue raised by abigail alliance in the near future, it appears timely to consider the ethical dilemmas 110. id. (quoting oaldand, 532 u.s. at 490). ill. id. 112. id. at 708-710. 113. id. 114. /d. 115. abigail alliance, 495 f.3d at 712. 116. id. 117. /d. 118. /d. at 713. 119. id. see also infra part n.b for a discussion about current legislative action regard­ ing patient rights to non-approved drugs. 2008] live or let om 137 and legal factors involved in the issue. because of the enormous rate of cancer and other terminal diseases in today's world, it is likely that almost every indi­ vidual has some connection to the topic. ira lupa, a professor of constitutional law at george washington university, acknowledged: this is the kind of case that you see tugging at people's heartstrings. . . . everyone has a :friend or a sibling, or, especially, a child who has a fatal illness .... you can see that the sympathies attached to this could push a judge who is otherwise quite disciplined over the edge.•zo furthermore, if the fmal decision of the supreme court results in a shakeup of the fda's regulatory scheme, that decision would likely affect, not only the terminally ill, but also the very nature of drug regulation in the united states today. iv. should the terminally ill be allowed to choose? a. considerations in favor of deregulation in the past decade, critics of the fda have been growing rapidly in both number and influence. there are numerous positions that both in favor and oppose the current state of fda regulation. aside from the obvious value of human life, economic, legal, and philosophical considerations must be consid­ ered in conducting an impartial analysis. this part of the note evaluates the most prevalent those viewpoints. the foremost argument for allowing expedited access to new drugs and treatments is that such access might increase the number of cancer survivors. too often, terminally ill patients have been denied the opportunity to receive a potentially life saving drug until it was too late. one such person was k.ianila karnes. diagnosed with kidney cancer in 2002, k.ianna karnes, a mother of four in brownsburg, indiana, sought treatment from her local doctors. 121 she began taking interleukin-2, which, at the time, was the only medication ap­ proved by the fda for use against kidney cancer.122 the side effects, however, were almost unbearable, so her father, john rowe, began seeking additional help. in 2004, rowe learned that the drug manufacturers pfizer and bayer had each developed drugs for kidney cancer and were in the process of conducting clinical trials.123 after k.ianna was denied access to the clinical trials, rowe 120. groopman, supra note 3. 121. id. 122. id. 123. !d. 138 indiana health law review [vol. 5:123 sought help from dan burton, a republican congressman from indiana. 124 on march 24, 2005, with burton's assistance, rowe finally received permission from the fda for kianna to use to the new drugs; kiana, however, died at 9:41 p.m., that same night. 125 in january 2006, both ofthe experimental drugs de­ veloped by pfizer and bayer were approved by the fda as safe and effective treatments against kidney cancer.126 unfortunately, the case of kianna kames is similar to many others. by the time the fda acted, it was too late to help the terminally ill patient. had kianna gained access to the drugs when she first learned of them, they might have saved her, or at least prolonged her life until a better treatment was devel­ oped. kianna's case was unique, however, in that it generated a great deal of noise in congress. in fact, a law calling for the deregulation of the fda, cur­ rently before the house and senate, was inspired by and named after kianna kames. 127 all too often terminally ill patients are forced to sit, wait, and die while a drug passes through all three phases of testing. indeed, it can take a drug up to twelve years for a drug to complete the required testing and gain fda ap­ proval;128 however, a typical terminally-ill patient usually has only a couple of years, at most, to live. even dr. scott gottlieb, a physician and former senior official for the fda, has recognized that a problem exists. "delaying new treatments for the sake of generating more rigorous and complete medical evi­ dence helps patients, to a point. but in the field of cancer ... the fda's strict posture is probably overkill."129 dr. gottlieb went on to say that "[t]he fda is trying to save patients from the harmful effects of new medicines that haven't fully proved their mettle. in the process, many more patients will die waiting for the good medicines than from using the bad ones. "130 another terminally ill patient adversely affected by the fda's testing scheme wasabigail burroughs, whose death lead her father, frank, to found the abigail alliance for better access to developmental drugs.131 abigail, at only twenty-one years of age, died from cancer in 2001 after being denied access to 124. jd. 125. groopman, supra note 3. 126. jd. 127. see infra part iv .a. 128. walsh & pyrich, supra note 20, at 933. 129. scott gottlieb, m.d., fda's caution hurting patients, oklahoman, may 30, 2005, at 19a. !d. 130. jd. see also walsh & pyrich, supra note 20, at 942 in the time taken to conduct a full review of an nda, thousands of lives might be saved or improved by a new drug or medical device. moreover, as a result of the long time frame for new drug approval, consumers con­ tinue to rely on drugs which, while possibly less safe or less effective, have already been approved. 131. robert manor, fda seeks to ease access to new drugs, cm. trib., dec. 12, 2006, atcl. 2008] live or let dm 139 erbitux, a drug used to treat cancer of the head, neck, and colon. 132 though erbitux displayed effectiveness during its early clinical phases for treating vari­ ous forms of cancer, it was not distributed until receiving the fda's final ap­ proval.133 as a result, frank burroughs decided to fight for those who are in the position his daughter was once in. the abigail alliance is given much cre­ dit for leading the fight against the fda and advocating for patient rights. one argument against deregulation is the increased risk of potential side effects, but most people who are faced with imminent death are less likely to be concerned about a side effect if there is a chance that their life may be pro­ longed. furthermore, side effects could hardly be complained ofby terminally ill patients who know all too well that the drugs they are taking have not been fully tested. ultimately, given a choice between prolonging life and the possi­ bility of discomfort or death caused by unknown side effects, a great majority of the population would likely choose the former. there are alternatives that allow terminally ill patients expedited access to newly manufactured drugs. 134 for example, clinical trials conducted during the three phases of the fda's approval process are often opened to those patients with the most serious need. a number of problems are, however, associated with the determination of patient qualification for participation in, and the ad­ ministration of such clinical trials. one problem with these clinical trials is the use of placebos. a patient group in a clinical trial is usually divided with a portion of the population get­ ting the actual drug while the remaining patients receive a placebo. 135 this di­ vision allows the doctors to more efficiently monitor the performance and effectiveness of the drug being tested. this testing methodology, however, though scientifically sound, presupposes that at least some terminally ill pa­ tients will receive a placebo with no beneficial qualities. how then, should medical professionals determine which terminally ill patients get the placebo? such a decision, by its very nature, allows a doctor to "play god" by deciding which patients deserve the best shot at survival. clearly, those patients who receive the placebo would be better off if everyone had access to the drug being tested. another issue that arises out of clinical trials is that not all applicants are permitted to participate. for example, a history ofbrain cancer almost always disqualifies a patient from admittance into a clinical trial. 136 brain cancer makes a patient more prone to seizures and can cause symptoms that might in132. jd. 133. jd. 134. see infra part iv.b for an in depth look into alternative paths to various available treatments. 135. editorial, last hope: terminally ill people should have access to experimental drugs, the columbus dispatch (ohio), dec. 20,2006. see also pressure for new us fda experimental drug regulations could create problems, pharma marketletter, dec. 15, 2006. 136. groopman, supra note 3. 140 indiana health law review [vol. 5:123 terfere with the evaluation of the medication. 137 it was for this very reason that kianna karnes was denied access to the clinical trials for the potentially lifesav­ ing drugs designed by pfizer and; her cancer had spread into her brain.138 also, it may be too expensive or inconvenient for terminally ill patients to get into an applicable clinical trial. indeed, most clinical trials take several years to complete139, and drug companies are likely to conduct such trials at either their own laboratories or in an academic medical center which may be located far from a participant in need.140 furthermore, some american drug companies have been unable to recruit sufficient numbers of interested patients and, as a result, have begun to conduct trials in europe and asia. 141 gathering the money necessary to make such a move may not be an option for many ter­ minally ill patients. moreover, if a terminally ill patient has a short life expec­ tancy, he or she might prefer to spend his or her remaining time with loved ones in familiar setting, rather than in an unknown place with invasive clinical moni­ toring. clearly, there are a number of reasons to deregulate the fda's control over unapproved drugs. additional reasons also arise specific to each patient's case. however, while the sympathetic and humanitarian part of the population might think that this issue should be quickly dealt with because of the value of the human life at stake, there are many other factors that play into the debate and which must, as a result, be considered. b. considerations against deregulation most people, including opponents of deregulation, can sympathize with individual patients, such as kianna karnes, who have been denied access to potentially life-saving treatments. however, ralph w. moss, a medical writer specializing in cancer treatments, noted that, "[w ]bile that sentiment is seem­ ingly humane, it is based on a false premise, for it wildly overestimates the ef­ fectiveness of most new anti-cancer drugs."142 furthermore, the impact of taking away the fda's authority could bring many unforeseen dangers and po­ tentially create more risks in the long run.143 one of the biggest and most obvious concerns associated with allowing non-approved drugs into the market is the inherent uncertainty of their effec137. ld. 138. jd. 139. see supra part ii.b. 140. groopman, supra note 3. 141. ld. 142. ralph w. moss, no way to save a life: allowing terminally rl cancer patients access to drugs that have not completed clinical trials is a dangerous move, says ralph w. moss, new scientist, june 3, 2006, at 21. 143. lois k. perrin, note, the catch-22/or persons with aids: to have or not to have easy access to experimental therapies and early approval for new drugs, 69 s. cal. l. rev. 105, 145 (1995). 2008] live or let dm 141 tiveness. recall that in abigail the plaintiffs requested, and the court approved, access to drugs after the completion of phase i trials!44 the problem is that .. [t]he vast majority of drugs in phase i trials are not lifesaving; they are not even life-prolonging."145 without complete testing, a large number of ineffec­ tive, and possibly dangerous, drugs will likely find their way into the market. many patients ''will increasingly fall prey to exaggerated claims for various half-baked drugs, as a result of skillful manipulation of public opinion."146 desperate patients may hear the untested claims of new drugs and ignorantly consume drugs which could pose greater risks than benefits. typically, when new drugs are consumed, it is under the watchful eye of clinical testing. with deregulation, however, side-effects may occur in an un­ controlled atmosphere without any experts nearby to aid the patient. the pri­ mary purpose of the fda is to ensure that public health is not put at risk by dangerous drugs. indeed, a newly available drug may have .. a smaller than ex­ pected benefit and a larger than expected adverse effect that could not be rec­ ognized without large scale clinical trials of long duration."147 deregulation could, therefore, serve to erode the monitoring system established by the fda; thereby, permitting our drug industry to once again exhibit the deficiencies common in the days of elixir sulfanilamide and thalidomide.148 phase i testing, opponents of deregulation argue, is not an effective enough screening process to serve as a catch-all before releasing drugs.149 one such opponent explained: there are very small numbers of participants in phase i, and they are treated for a very limited period of time. so if you believe that there is this constitutional right, that there are risks you are willing to take and not have the government interfere, why have a cutoff at phase i? why not just say, 'any drug i'm willing to take,' be­ cause of some anecdotal experience, or some animal study, or the molecular structure, is reason to think the drug might work?150 also, phase i does not test as much for effectiveness as it does safety.151 there­ fore, even if a terminally ill patient gets his hands on a post-phase i drug that 144. abigail alliance v. eschenbach. 445 f.3d 470, 473 (d.c. cir. 2006). 145. moss, supra note 142. 146. id. 147. perrin, supra note 143, at 144. 148. abigail alliance, 445 f.3d at 482. 149. groopman, supra note 3. 150. groopman, supra note 3, (quoting sonia suter, a professor oflaw at george wash­ ington university and an expert in medical ethics). 151. see supra part ll.b. 142 indiana health law review [vol. 5:123 won't harm him, he could be spending unnecessary money, hope, and time with a drug that produces no results. another serious concern with deregulation is the impact that it would have on clinical trials. these trials are the most important part of the approval proc­ ess.152 they provide the data and results which are used to determine whether a drug meets the market standards for safety and efficacy. if, however, drug manufacturers are allowed to bypass the clinical trial process, many patients will lose their incentive to participate in such trials.153 if patients are able to obtain experimental drugs on their own, they suddenly have little reason to in­ cur the cost and inconvenience ofleaving home to participate in trials. 154 while on its face this may appear to be a benefit to terminally ill patients, the long­ term results could prove devastating to the medical industry. drug companies already have a difficult time recruiting patients to par­ ticipate in clinical trials.155 with deregulation, clinical trials, on a local level, might become cost ineffective. this could mean the end of scientific and medi­ cal studies in human clinical testing. as professor norman c. frost explained, there's a strong societal interest in advancing knowl­ edge and having new drugs done in trials first rather than in the marketplace, because otherwise we don't learn anything and we waste not only lots of money but some­ times lives, and there's no advancement so we remain in a state of perpetual ignorance.156 clinical trials provide drug companies and the medical industry with much cut­ ting edge knowledge directly related to the treatment of terminal illnesses. if the ability to effectively conduct such trials is lost, then the ability to treat ter­ minal illnesses could be adversely effected. moreover, the loss of clinical trial efficacy could undercut the preferences of those patients who desire to take drugs only after they have passed clinical testing. therefore, "the benefit of a few desperate [and outspoken patients] would come at a steep cost for the rest of us ... :•m instead, opponents argue that there needs to be a balancing of interests between those who want immediate access to untested drugs and those who prefer to wait for the fda's stamp of approval. 158 another possible effect of deregulation is that drug manufacturers could lose their incentive to conduct thorough research. if drug manufacturers know that they do not have to meet the same standards of the fda's current approval 152. casanova, supra note 12. 153. groopman, supra note 3. 154. /d. 155. see supra part iv .a. 156. casanova, supra note 12 (dr. fostis professorofpediatricsandthecbairoftheetbics committee at the university of wisconsin hospital). 157. ezekiel j. emanuel, drug addiction, newr.i!pubuc, july 3, 2006, at 9. 158. casanova, supra note 12. 2008] live or let die 143 process, what motivation will they have to go above and beyond to ensure a drug's safety and effectiveness? not only is medical and pharmaceutical re­ search costly, but it also takes time to conduct preliminary testing. deregula­ tion would almost necessitate that drug manufacturers pursue a guess-and­ check strategy. .as such, drug manufacturers would be tempted to get a drug into the market quickly, without regard for potential liability, in order to test the drug's effectiveness and gain a quick return on their investment this raises another problem: who does liability fall upon if there is no regulation? pending legislation concerning this matter, discussed supra, stipulates that drug manufactures cannot be held responsible for a patient's adverse reactions to experimental drugs. 159 so if a drug manufacturer cannot be held liable for its own dangerous drug, then who assumes liability? the result could be an un­ precedented degree of assumption of risk. also, if there is no liability for such drugs, ignorant retailers with little or no scientific experience might be encour­ aged to take their shot at drug manufacturing. this scenario "opens the space for products that are sold by charlatans."160 the dangers that are posed by such a situation are blatantly obvious. in the alternative, if drug manufacturers are held liable in a world of de­ regulation, they may lose incentive to make experimental drugs widely avail­ able. 161 currently, drugs are not approved for medicare or for insurance purposes until after they have completed the fda's approval process.162 if drug manufacturers are unable to obtain appropriate insurance or find distribu­ tors because they distribute drugs that have not yet satisfied the fda's approval process, they may choose to completely forego the liability of such exposure and proceed with the fda's approval process before releasing the drugs into the market; thereby, completely bypassing terminally ill patients in immediate need. c. legal concerns regarding deregulation versus the right of terminally ill patients to choose non-fda approved drugs apart from institutional factors surrounding the debate over deregulation, the outcome will also likely raise legal concerns in the health law industry. in his dissenting opinion in the en bane panel's decision of abigail alliance, jus­ tice thomas griffith, who wrote the majority opinion for the full bench, raised several legal issues posed by the issue o(terminally ill patients and experimen­ tal drugs. while these issues were not discussed in the latter decision, they are of importance in analyzing the matter of deregulation. 159. groopman, supra note 3. 160. groopman, supra note 3 (quoting david parkinson. an oncologist who worked at the national cancer institute and who now serves as senior vice-president of a large biotech company). 161. ld. 162. ld. 144 indiana health law review [vol. 5:123 justice griffith's first question related to the definition of ''terminally ill patients" and the breadth of its application. "'(a]re patients with serious medi­ cal conditions entitled to the benefit of the same logic and corresponding ac­ cess?"163 why should a patient suffering unbearable pain, or plagued with a lifelong illness, be denied a potentially pain-relieving drug simply because she is not guaranteed that she will die as a result ofher illness? it is difficult to ar­ gue that such a patient's suffering is less worthy than that of a person facing imminent death. another question posed by justice griffith was whether a patient can ac­ cess any drug if, after consulting a physician, she believes that it will ease her suffering or possibly save her life.164 one can easily picture individuals devis­ ing ways to take advantage of such an opportunity, claiming that, narcotics will save them from a lifetime of pain. indeed, under such a theory, the movement to legalize medicinal marijuana might also regain momentum, as advocates look for loopholes in deregulation.165 how would the system distinguish between non-approved medicinal drugs from those generally thought of as narcotics? along that same line, a question that justice griffith thought most signifi­ cant was ''what potential must a treatment have in order for the constitution to mandate access?"166 if a patient does have a fundamental right to a potentially life-saving medication, the government probably has little role to play in decid­ ing its actual effectiveness. the abigail alliance, however, has requested ac­ cess to drugs only after they have passed through phase i. the fda, therefore, would still have a large role in deciding what drugs pass through the first phase of trials. but should those standards be relaxed or tightened? still another concern is that untested drugs could fall into the wrong hands. a scenario can be imagined in which a terminally ill patient is given free access to new drugs. how will the government ensure that such drugs stay with the terminally ill patient? there is a definite concern that a surplus of un­ tested drugs could enter the market and become available to those without a fundamental interest in them. the debate over deregulation has given rise to many questions and legal concerns. congress and the fda have begun to address some of these con­ cerns. despite the fact that the panel's decision was vacated, however, its hold­ ing generated such a buzz within the medical industry that it prompted what may be considered a preemptive strike by the fda. 163. abigail alliance, 445 f.3d at 499 (griffith, j., dissenting). 164. id. 165. see gonzales v. raich, 545 u.s. 1, 1 (2005) (affinningcongress' power to regulate intrastate marijuana consumption, even for medicinal purposes) . . 166. abigail alliance, 445 f.3d at 499 (griffith, j., dissenting). 2008] live or let die v. the future of 1he fda's approval process regarding terminally ill patients' access to unapproved drugs a. a preemptive strike? 145 on december 11, 2006, less than three weeks after its appeal was granted and the district of columbia circuit court announced that it would rehear the abigail case, the fda announced that it planned to make changes intended to help terminally ill patients more easily access new drugs.167 in part, the changes entailed broadening the guidelines for when such drugs may be used and making those guidelines more explicit within the medical industry.168 the fda hopes this "will give physicians clear directives on when to grant access to medications, even perhaps at the very earliest stage of development, in cases in which the potential benefit is deemed to outweigh the risks. "169 because doctors are not regulated by the fda, they often prescribe drugs for different off-label uses, not realizing that the drug has not been approved for such use.170 increasing the awareness among physicians will hopefully deter them from providing patients with false hope in some ineffective drugs. furthermore, the fda realizes that many viable treatment options have been overlooked.171 one spokesman for the fda announced,"[ w ]e expect that clearly articulating procedures and standards for expanded access will result in more patients with serious or immediately life-threatening diseases or condi­ tions getting the earliest possible access to these therapies. "172 the fda, how­ ever, has not been very specific or detailed in explaining exactly how it plans to allow access to new drugs for terminally ill patients. it is possible that the announcement was a preemptive strike, made in re­ sponse to the future rehearing of the abigail case. if the fda can portray itself as an adaptable agency capable of taking responsibility for making changes, then the court may be less likely to impose its own strict standards on the agen· cy. only with the passage of time will we be able to determine the sincerity of the fda's new plan of reform and the effectiveness of its proclaimed changes. b. legislative action senator sam brownback ofkansas and representative christopher shays of connecticut have introduced bills in the senate173 and house ofrepresenta167. manor, supra note 131. 168. ld. 169. id. 170. abigail alliance, 445 f.3d at 483. 171. manor, supra note 131. 172. id. 173. access, compassion, care, and ethics for seriously-ill patients act, s. 1956, 1 09th cong. (2005). 146 indiana health law review [vol. 5:123 tives174, respectively, to amend the federal food, drug, and cosmetic act. the legislation would create a new three-tiered approval system for drugs, biologi­ cal products, and medical devices that is responsive to the needs of seriously ill patients.175 the access, compassion, care, and ethics for seriously-ill patients act, better known as the access act, was introduced in the senate on no­ vember 3, 2005, and was referred to the committee on health, education, la­ bor, and pensions the same day.176 the bill was introduced in the house on september 29, 2006, and was referred to the subcommittee on health on octo­ ber 2, 2006.177 although this legislation is still pending, if passed, it could se­ riously shake up the fda and its current approval process. in effect, the access act appears to effectively upend the fda's cur­ rent regulatory structure. some of the bill's pertinent findings include: (1) the necessity of placebo controlled studies has been questioned on both scientific and ethical grounds for se­ riously ill patients. (3) promising therapies intended to treat serious or life threatening conditions or diseases and which address unmet medical needs have received unjustified delays and denials of approvals. (5) the current food and drug administration and na­ tional cancer institute case-by-case exception for com­ passionate access must be required to pennit all seriously ill patients access to available experimental therapies as a treatment option. (8) the use of available investigational products for treatment is the responsibility of the physician and the patient.t7s the legislation's sponsors clearly do not favor the fda's methods or reason­ ing. indeed, the access act proposes an entirely new expedited approval process and grants much more rights to the tenninally ill. the access act would provide greater access to new drugs in several ways. first, the bill proposes an expedited three-tiered system, with established timeframes, that a drugs' sponsor must meet. with regard to the first of the 174. access, compassion, care, and ethics for seriously-ill patients act, h.r. 6303, 1 09th cong. (2006). 175. h.r. 6303. 176. s. 1956. 177. h.r. 6303. 178. s. 1956 § 2. 2008] lne or let die 147 three tiers, a key difference in the approval process is that it is based primarily upon clinical evaluation rather statistical analysis. 179 in order for a new drug, treatment, or device to gain tier i approval, a sponsor must submit an applica­ tion containing: (i) data and information from completed phase i clinical investigations and any other nonclinical or clinical inves­ tigations; (ii) preliminary evidence that the product may be effec­ tive against a serious or life-threatening condition or dis­ ease, which evidence may be based on uncontrolled data such as case histories, information about the pharmacol­ ogical mechanism of action, data from animal and com­ puter models, comparison with historical data, or other preliminary information, and may be based on a small number of patients; and (iii) an assurance that the sponsor will continue clinical investigation to obtain tier iii approval. 180 it is evident that it would be easier and much less time consuming for a drug to gain tier i approval than it is for the same drug to gain phase i approval under the fda's current structure.181 a drug sponsor would have to show only that the drug or treatment could possibly be effective for its intended use. further­ more, it appears that a drug sponsor would be able to make this showing much sooner under the proposed system because the act would allow greater reliance on animal and computer testing, rather than waiting for patients to sign up and complete a number of clinical trials. the act also contains the safeguard that a drug sponsor must continue to pursue research and testing in order to complete all three tiers. this would deter drug manufacturers from simply relying on an incomplete (or preliminary) study without further follow up. instead, those manufacturers must be both accountable and efficient to fully promote their new drugs. also, the act requires the secretary, no later than thirty days after the receipt of an application, to either approve the application or refer it to a special committee. 182 another way in which the access act would expedite the process and provide greater access to drugs is that it requires the fda to establish an accel­ erated approval advisory committee.183 this committee, comprised of eleven 179. 8.1956§3. 180. id. (proposing to amend § 506(b )( l) of the federal food, drug, and cosmetic act (21 u.s.c. 356)) (emphasis added). 181. see supra part ii.b (discussing the length of time and the requirements that a drug must meet before receiving approval for phase i testing). 182. s. 1956 § 3 (proposing to amend§ 506(b)(2) of the federal food, drug, and cos­ metic act (21 u.s.c. § 356)). 183. s. 1956 § 3 (proposing to amend§ 506 of the federal food, drug, and cosmetic act 148 indiana health law review [vol. 5:123 members, 184 will, upon a referral by the secretary, have ninety days to review an investigational new drug.185 within thirty days of receiving the accelerated approval advisory committee's recommendation, the secretary must decide whether or not to approve the drug for the requested tier.186 th~ criteria to be considered in deciding whether or not to approve an ap­ plication are based upon a balanced consideration of the risks posed by the dis­ ease and the potential risks of the proposed drug. ..if the potential risk to a patient of the condition or disease outweighs the potential risk of the product, and the product may possibly provide benefit to the patient, the secretary shall approve the application."187 once a drug has achieved tier i approval, it is to be made available only to a patient whose physician has documented in writing that the patient has exhausted all other available options and that none were effective.188 also, the patient must give informed written consent, sign a waiver of the right to sue the drug's sponsor and manufacturer and the physician who rec­ ommended the drug, and consent to release to the drug manufacturer informa­ tion about the patient and his or her use of the drug. 189 this provision addresses many of the concerns presented by critics of deregulation. it insures that liability will not rest with any party involved in the transaction. instead, a patient assumes all risk in undertaking the treatment. furthermore, the provi­ sion insures continuing research and testing of the drugs by requiring patients to submit data and information relating to their treatment. additionally, while the standards for tier ll approval are similar to those of tier i, it requires more than a mere possibility of effectiveness. a drug's sponsor must demonstrate that its product "has an effect on a clinical endpoint . . . that is reasonably likely to predict clinical benefit to a patient ... suffering from a serious or life-threatening condition or disease."190 finally, tier m approval meets the same standards as that which is al­ ready defined by the fda. one last interesting proposed element of the access act is that it allows the secretary to withdraw tier i and tier ll approval in four situations. spe­ cifically, approval can be withdrawn if: (1) the sponsor fails to conduct continu­ ing studies with due diligence; (2) a post-approval study fails to verify the (21 u.s.c. § 356) to add a new subsection (g)). 184. s. 1956 § 3. 185. id. (proposing to amend§ 506(b)(2)(b)ofthefederal food, drug, and cosmetic act (21 u.s.c. § 356)). 186. s. 1956 § 3 (proposing to amend§ 506(b)(2)(c) of the federal food, drug. and cosmetic act (21 u.s.c. § 356)). 187. s. 1956 § 3 (proposing to amend§ 506(b) of the federal food, drug, and cosmetic act (21 u.s.c. § 356) by adding a new paragraph (b)(4)). 188. s. 1956 § 3 (proposing to amend§ 506(b)ofthefedera1food, drug, and cosmetic act (21 u.s.c. § 356) by adding a new subparagraph (b)(5)(a)). 189. id. (proposing to amend § 506(b) of the federal food, drug, and cosmetic act (21 u.s.c. § 356) by adding a new subparagraph (b )(5)(b)). 190. s. 1956 § 3 (proposing to amend§ 506 ofthefederalfood,drug. and cosmetic act (21 u.s.c. § 356) by adding a new subsection (f)). 2008] live or let die 149 product's benefit for even a small patient subpopulation; (3) evidence is intro­ duced demonstrating that the product is not safe or effective for even a small patient subpopulation; or ( 4) the drug's sponsor disseminates false or mislead­ ing promotional materials and fails to promptly correct the material after receiv­ ing written notice. 191 this provision acts as another check on manufacturers to ensure that they remain accountable to the fda. the access act would clearly upend the fda's current approval sys­ tem and provide better access to the terminally ill. the legislation, however, still leaves room for debate over the subpopulation to which expedited access is available and the use of narcotics such as medicinal marijuana. furthermore, the access act has been pending before congress for over a year with no results. it is still unclear whether senator brownback and representative shays will prevail before their colleagues. given the debate's history and rising inten­ sity, it seems rather clear that this will not be the last bill of its kind proposed in congress. c. drug regulation around the world as noted above, the fda's current regulatory structure, for drugs, is con­ sidered to be the most stringent in the world.192 compared to other countries, it is much more difficult to get access to drugs in the united states because of the . stricter standards and longer testing phases required here. the result is that 'many american patients will often flee to other countries where potentially life­ saving drugs are made more available. it is sad to think that a regulatory struc­ ture designed to protect the people of the united states drives consumers to other, sometimes poverty-stricken nations, to get one last shot at survival. giv­ en this reality, it is necessary to ask: (1) how other countries regulate their drugs, and (2) whether those regulatory schemes have been successful. 1. great britain although the british drug approval system resembles the american ap­ proach more closely than any other nation's system, it is generally recognized as more objective and expeditious than the fda's structure.193 the primary mechanism for prescription drug regulation in great britain is the medicines act of 1968.194 under the act, the medicines division of the department of health and social services first issues certificates that allow drugs to be admin191. s. 1956 § 3 (proposing to amend§ 506(cx1xa) of the federal food. drug, and cosmetic act (21 u.s.c. § 356)). 192. see generally dillman, supra note 4. 193. dillman, supra note 4, at 931 (citing note, international trends in new drug ap­ proval regulation: the impact on pharmaceutical innovation, l 0 rutgers computer & tech. l.j. 317,317 (1984). 194. id. at 932. 150 indiana health law review [vol. 5:123 istered to human beings and then issues licenses allowing the drugs to be mar­ keted to the public.195 one significant difference between the american and british systems is that, in britain, certification is not required for physicians who want to adminis­ ter drugs to their own patients for therapeutic use.196 thus, the british system provides more flexibility to resident doctors than does the fda. furthermore, drugs are usually made sooner and more widely available to the british market. before the passage ofbritain's medicines act, the united states led great britain in drug development197 since that time, however, great britain has turned the tide, shepherding drugs through the development process, on aver­ age, five years faster than in the united states.198 furthermore, according to a test conducted after the passage of the medicines act, "great britain had nearly four times as many exclusively available drugs in the same time period as did the united states."199 in spite of britain's faster and greater distribution of drugs to its consumers, there have not been any findings of excessive new drug toxicity as a result200 2. germany germany is the global leader in the availability of pharmaceutical drugs. 201 it has some 8900 available drug products compared to the 6000 available in the united states. 202 although some of the disparity can be attributed to the fact that many large drug manufacturers, such as pfizer, reside in germany, ger­ many's less burdensome regulation also contributes to the large number of available drug products there. while the regulation of drugs in the united states is the responsibility of government officials, that responsibility in germany mainly lies with members of the medical profession, which has "retained greater autonomy to design and oversee clinical testing. '.2°3 another difference between the two nations is that ''patients in the united states increasingly challenge expert risk assessments and demand access to drugs, even in early stages of clinical trials. a compara­ ble politics of patient identity and access to medicines is strikingly absent in germany, where professional associations continue to opemte as intermediaries 195. !d. the clinical trial certificates and marketing licenses last for two and five years, respectively, after which time renewal is required. id. 196. !d. at 933. 197. walsh & pyrich, supra note 20, at 939-40. 198. !d. at 940. 199. dillman, supra note 4, at 934. 200. !d. at 934-35. 201. ar.nrur a. 0aemmrich, pharmacopouitcs: drug regulation in the united states and germany 9 (the univ. of n.c. press 2004). 202. !d. 203. id. at 6. 2008] live or let die 151 between citizens and the state."204 whether or not this is a result of german culture or politics, it is clear that the delegation of drug monitoring to the medi­ cal profession has improved the access to drugs in germany. furthermore, the fact that many of the world's largest drug manufacturers reside in germany is evidence that the system there is working. 3. world health organization the world health organization ("wh0")205 works to fulfill its goal in es­ sential drug and medicine policy by providing global guidance on essential me­ dicines. specifically, who works with countries around the world to implement national drug policies that ensure equitable access to essential medi­ cines, the quality and safety of medicines, and, by implication, the rational and systematic use of medicines. 206 in many of the countries within who is work­ ing, including kenya, myanmar, and vietnam, only fifty percent of drugs on the market are registered. 207 because of the lack of regulation in these coun­ tries, there are large amounts of counterfeit drugs in the market.208 further­ more, failed drugs from other countries are often smuggled into these markets; thereby, creating even greater risks.209 for these reasons, americans should be careful when traveling to other countries, especially third-world countries and countries without systematic drug regulation systems, to receive broader access to alternative treatments. for some terminally ill patients, however, traveling to another country for treatment is their one last shot to receive a drug that has been denied to them by their own government. d. privatization as an alternative one proposed solution to the delays and costs engendered by the fda's approval process is privatization, "namely, delegation of some of the fda regulatory functions to private entities under fda supervision."210 privatiza­ tion has been a solution to numerous governmental regulatory problems in the past, including railroads, development, and building contracts.211 delegation of 204. id. 205. the world health organization ("who") is the united nations specialized agen­ cy for health. it was established on april 7, 1948 with the objective of helping all people to attain the highest possible level of health. health is defined, in who's constitution, as "a state of complete physical, mental, and well-being and not merely the absence of disease or infirmity." who const. pmbl., available at http://www.who.int/governance/eb/ who_ constitution_ en. pdf. 206. see wondemagegnehu, supra note 15. 207. /d. at 34-35. 208. see/d. 209. see/d. 210. walsh & pyricb, supra note 20, at 954. 211. !d. 152 indiana health law review [vol. 5:123 the fda's regulatory duties would allow it to take advantage of a number of benefits that are typically not available to government agencies: the first advantage of delegation is that it would allow the government to use the expertise and resources available in the private sector.212 private entities are usually able to pay higher salaries and offer more benefits; thereby, attract­ ing better, talented, and more experienced individuals who are not always available in the market for public employment. 213 furthermore, delegation pre­ serves scarce government resources as private parties can often operate and function more efficiently than the government.214 another advantage of privatization is that private entities are not subject to politics. 215 "since private parties are not dependent on ... public ... fund­ ing, they may more freely address politically sensitive issues. "216 also, the pri­ vate sector does not have to deal with the bureaucratic processes and procedural restrictions often imposed on government agencies; thereby, enabling them to respond more efficiently in many circumstances.217 privatization, however, is an unlikely alternative. the fda "has been re­ luctant to yield its authority over drugs and medical devices for fear that public health and safety will be compromised.'o218 furthermore, private entities may be reluctant to assume the liability that comes with the territory. nevertheless, privatization remains a possible solution to the problem. vi. conclusion the issues surrounding access of the terminally ill, to drugs and treat­ ments unapproved by the fda, involves emotionally charged stories such as those of.kianna karnes and abigail burroughs. these stories complicate and humanize the issues involved, because it is human nature, not only to mourn the loss of a valuable life, but also to fight for survival. given the compelling na­ ture of these tales, it is easy to respond to the emotional pull of this issue by summarily concluding that deregulation is the obvious answer: indeed, on a fundamental level, it seems logical to assert that government should not be permitted to interfere with an individual's right to survival. moreover, if a ter­ minally ill patient wants to assume the risks associated with the use of an unap­ proved, but potentially lifesaving drug, then the urge is strong to permit him or her to take that risk, especially when the patient faces imminent death anyway. the thought of government forcing a dying person to wait, while dangling the 212. ld. 213. id. at 955. 214. ld. 215. id. at 956. 216. walsh & pyrich, supra note 20, at 956. 217. ld. 218. ld. at 1040. 2008] live or let die 153 hope oflife over her head, while a decade of clinical testing is completed, can seem seriously offensive and cruel. this issue, however, is more complex than that simplistic approach, and emotions can distort otherwise rational and unbiased minds. while some may not even want to consider arguments against letting a dying individual to re­ ceive potentially life-saving treatment, those arguments are do exist and possess strength of reason. there is, and should be, great empathy for those who have lost someone close or who currently suffer from a terminal illness, but the an­ swer to this problem is more complicated than simply opening the gateway to pharmaceutical drugs for every person faced with death. in reality, the negative consequences of deregulation are quite evenly balanced with its benefits. these considerations notwithstanding, however, the fda's approval process definitely needs modification. ten years is too long for the public­ and especially the terminally ill-to wait for drugs to be tested, approved, and made available. the united states should look to great britain for guidance, because it has managed to maintain a reasonable level of safety but has still been able to get drugs into the market more quickly than the united states. also, senator brownback's access act proposes many suggestions that could revolutionize the fda's approval process. just how long it would take, however, to fully implement a new system is presently unknown. even so, terminally ill patients should not be forced to wait for a drug to pass through three phases of testing. expedited access to new treatments after phase ii, if not phase i, is more appropriate, given the short life expectancy for this group of individuals. also, expanded access to clinical trials conducted by both government and private entities should be made available to such patients. indeed, even if patients with a terminal illness do not possess a fundamental right to obtain potentially life-saving drugs, the basic right of self-survival should at least provide them access to clinical trials. assuming that the abigail alliance case reaches the supreme colllf19, it is difficult to gauge how the court will determine the issue. regardless of whether the court recognizes a fundamental right in terminally ill patients to the use of experimental drugs, there will likely be modifications to, if not an overhaul of, the current system because it is currently producing unsatisfactory results. whatever the court decides, it seems certain that this debate will not, as have so many terminally ill patients, go quietly into the night. 219. abigail alliance v. eschenbach, 495 f.3d 695 (d.c. cir. 2007),petitionfor cert. filed, 76 u.s.l.w. 3189 (u.s. sept. 28, 2007) (no. 07-444). follow-on biologics legislation: striking a balance between innovation and affordability brian r bouggy • i. introduction ......•..............•......•......•......•..•...•.......•............•.•...•.. 368 ii. background ..............•......•....•..•......•......••...•.•......••..........•.......... 372 a. biologics .................................................................................. 372 b. health care expenditures associated with biologics ............. 373 c. competing views regarding follow-on biologics ..................... 374 d. degrees of exclusivity granted to innovators by generic legislation ............................................................................... 378 1. genera/agreement on tariffs and trade (ga1t) ............ 380 2. the inhibitory effect of exclusivity provisions on innovation .......................................................................... 381 3. access distortion ............................................................... 382 4. hatch-waxman actvery limited exclusivity ................... 383 a. potential savings associated with follow-on biologics ...................................................................... 383 b hatch-waxman's effect on follow-on biologics .......... 384 e. proposed legislation ............................................................... 385 f. shorter exclusivity periods may actually promote innovation . ............................................................................... 387 1. the generic pharmaceutical association's response to the kotlikoff study: .................................................................. 388 iii. analysis: modified version of hatch-waxman applicable to biologics ................................................................................. 390 a. downfalls of proposed biogenerics bills .................................. 390 1. cost/risk justification argument ........................................ 391 b. the hatch-waxman act should be used as a template for generic biologics legislation .................................................. 391 c. congress should assess the arguments from these two inherently biased groups with a focus on our country's biotech consumers .................................................................. 392 d. biogeneric legislation as a catalyst for innovation . ................ 394 e. economic/welfare implications ............................................... 394 f. exclusivity provisions should allow for abbreviated periods of monopoly protection . ............................................................... 395 n. conclusion .................................................................................. 396 • j.d., 2010, indiana university school of lawindianapolis; b.s., 2007, purdue university. 368 indiana health law review [vol. 7:367 i. introduction recent scientific advances have resulted in new drugs and biological compounds which provide incredible life-saving potential, but come with a high price tag. 1 biologics, such as insulin and various cancer drugs, pro­ duced by extracting cellular proteins from animals, are changing the land­ scape of modem medicine. there exists remarkable potential for the discovery of new life-saving biologics, but the consumer too often bears the high cost of access to these revolutionary treatments. on average, biologics cost twenty-two times more per daily dose than chemical medications? many biologic cancer treatments cost over $100,000 a year.3 in the united states, spending on biologics has increased approximately fifteen to twenty percent annually, and exceeded $40 billion in 2006.4 this note will de­ scribe the barriers generic drug makers face when seeking approval of ge­ neric biologics. it will then assess the meritorious arguments of each side of this hotly debated issue. finally, this note will describe how a balance should be struck by lawmakers implementing new legislation to reduce ris­ ing medical costs by permitting the marketing of generic biologics, while maintaining these drugs' initial profitability, which will in turn continue to encourage innovation. biologics offer remarkable hope to those fortunate enough to gain access to them. currently, compounds either being developed, being tested or on the market fight an array of conditions including arthritis, asthma, alzheimer's disease, heart disease, crohn's disease, various cancers, pso­ riasis, multiple sclerosis, lou gehrig's disease, and aids. 5 these and oth­ er serious conditions treated by biologics account for a substantial portion of our nation's health problems, and a similarly substantial portion ofhealth care spending. itis paramount that congress implement new legislation in a manner which will promote innovation in this field and maximize the po­ tential of these discoveries, while simultaneously making biologics more affordable to the general public. 1. health premium hikes tied to costly specialty dnlgs, ins. j., dec. 6, 2006, http://www.insurancejoumal.com/news/east/2006112/06n4723.htm (last visited oct. 27, 2009). 2. centers for medicare and medicaid, national health expenditures by type of service and source of funds (2008), http://www.cms.hhs.gov/nationalhealthexpenddata/ 03 _nationalhealthaccountsprojected.asp qast visited oct. 29, 2009). 3. health premium hikes tied to costly specialty drugs, supra note 1. 4. biologics price competition and innovation act of2007, s. 1695, (as reported by s. comm. on health, education, labor and pensions, jun. 27, 2007) (recognizing this ex­ penditure is being made primarily via third-party insurers or the government). 5. pharmaceullcal research and manufacturers of america (phrma), 2006 report on medicines in development biotechnology: 418 biotechnology medicines in testing promise to bolster the arsenal against disease 1 (2006), available at http://www.phrma.org/files/biotecho/o202006.pdt) (last visited feb.12, 2009) [hereinafter "phrma report'1. 2010] follow-on biologics legislation 369 until the recent passage of the patient protection and affordable care act of 2009, food and drug administration (fda) regulations precluded the marketing of generic forms of biologics, often referred to interchangea­ bly as biogenerics, biosimilars, or follow-on biologics. 6 the justification for more stringent control of biologics than of chemical drugs lies in the theory that the complexity of biologics renders them less amenable to safe and effective duplication by generic manufacturers. 7 as the scientific community learns more about biologics, however, it appears increasingly likely that many of these drugs can be safely and effectively duplicated. at a time when medical costs are increasing at an alarming rate, con­ gress must consider all viable options for reducing this inefficient sector of our economy. health care spending in the united states totaled $2.4 trillion in 2008 and is projected to reach $3.1 trillion in 2012, and $4.3 trillion in 2017.8 health care costs accounted for approximately seventeen percent of our nation's gross domestic product (gdp) in 2008, and is projected to ac­ count for almost twenty percent of our gop in 2017.9 prescription costs, particularly for extremely expensive biologics, are a major cause of rising medical expenditures.10 these expenses have a significant financial impact on individuals, employers, our government, and the world at large. indi­ viduals faced with the life-threatening specter of cancer may be forced to deplete their finances to the point of bankruptcy in order to receive the treatment recommended by their oncologist.11 harvard university researchers recently published findings which suggest the average out-of-pocket medical debt for individuals who filed for bankruptcy is $12,000.12 approximately seventy-five percent of those fil­ ing for bankruptcy in the study had health insurance, and fifty percent of all bankruptcy filings were caused, at least in part, by medical expenses.13 the reality of this problem is put into sobering perspective by the fact that every thirty seconds in the united states someone files for bankruptcy in the af6. see federal food. drug, and cosmetic act, 21 u.s.c. § 301 et seq. (1938). 7. letter from john taylor, executive vice president, health, biotechnology indus­ try organization, to secretary, federal trade commission (dec. 22, 2008) available at http://www.ftc.gov/os/commentslhealthcarecompissues/537778-00042.pdf (last visited mar. 6, 2010) [hereinafter "letter from john taylor"). 8. sean keehan, et al., health spending projection through 2017: the baby boom generation is coming to medicare, 2 healm affairs w145,w145 (2008), http://content healthaffairs.org/cgilcontentlabstract/27/2/w145 (last visited mar. 15, 2010). 9. /d. 10. wendy h. schacht & john r. thomas, follow-on biologics: intellectual property and innovation issues, congressional research service (aug. 3, 2009), available at http://www.assets.opencrs.com/rpts/rl33901_20090803.pdf(last visited mar. 6, 2010). 11. david u. himmelstein, et al., market watch: illness and injury as contributors to bankruptcy, health affairs, feb. 2, 2005, at w5-63,w5-64, http://content.healthaffairs. org!cgilcontentlfull!hlthaff.w5.63/dc1 (last visited mar. 1, 2010). 12. !d. at w5-63. 13. ld 370 indiana health law review [vol. 7:367 termath of a serious health problem.14 therefore, establishing a regulatory pathway for generic biologics would help provide both economic and phys­ ical relief to those faced with catastrophic illness. the more than 47 million americans without health insurance are un­ likely to have access to these drugs at all. 15 additionalll, those with health insurance may not be covered for life-saving biologics.1 in response to the increase in expensive specialty drugs, many insurers are restructuring the system they use to determine which drugs they will pay for, and how much the patient is required to pay. until recently, insurance companies classi­ fied drugs in three tiers based on cost and whether less expensive alterna­ tives exist.17 under this tiered copayment structure, patients would pay a fixed amount, "$5 to $10 per month for a generic medication (tier 1), $20 to $30 for a moderately priced brand-name drug (tier 2), and $50 for a high­ priced brand-name drug (tier 3)."18 in response to the rising number of high-priced medications, many insurers have now implemented a fourth tier, under which patients must pay a fixed percentage (often 20 to 33%) for all fourth tier drugs. 19 with many biologic treatments costing well over $100,000 annually, access to these drugs is often impractical for even in­ sured middle-upper class families.20 unfortunately, many are faced with the tragic choice between pursuing effective cancer treatment or providing for family expenses. employers providing health benefits feel the economic impact of high­ priced biologics in the form of rapidly rising insurance premiums. united states employers saw their health insurance premiums rise by an alarming five percent in 2008 two times the rate of inflation. 21 as biologics be­ come more prevalent, it is becoming increasingly expensive for employers to insure a large workforce. to maintain the viability of the employment­ based insurance scheme, it is necessary to cut medical costs. failing to do so, when many employers are already cutting medical benefits due to the prohibitive cost of health care, could have catastrophic effects on our health 14. elizabeth warren, sick & broke, wash. post, feb. 9, 2005, at a23, available at http://www.washingtonpost.com/wp-dyn/articles/a9447-2005feb8.html (last visited mar. i, 2010). i5. u.s. dept. of commerce, economics and statistics administration, u.s. census bureau report: income, poverty, and health insurance coverage ln the united stales: 2005 20 (2006), available at http://www.census.gov/prod/2006pubs/p60231.pdf (last visited mar. 1, 201 0) [hereinafter "census report"]. 16. /d. i7. thomas h. lee, m.d., and ezekiel j. emanuel, m.d., ph.d., tier 4 drugs and the fraying of the social compact, 359 n. engl. j. med. 333, 333 (2008). 18. /d. 19. /d. 20. health premium hikes tied to costly specialty drugs, supra note 1. 21. the kaiser family foundation & health research & education trust, employer health benefits: 2008 annual survey i {2008), available at http://ehbs.kff. orglped/7790.pdf(last visited mar. i, 2010). 2010) follow-on biologics legislation 371 care system.22 allowing follow-on biologics would be an effective method to provide relief to employers, and would reduce the likelihood ofemploy­ ers discontinuing health benefits. the country's biggest insurer, the united states government, could al­ so benefit from follow-on biologics.z3 a congressional budget office re­ port released in december 2008 analyzes an abbreviated regulatory pathway for follow-on biologics as a potential measure to decrease federal health care expenditures.z4 the report estimates such a plan would save the medicare and medicaid programs $10.6 billion between 2010 and 2019.25 the benefits of a regulatory pathway for follow-on biologics in the united states would be realized worldwide. biogeneric legislation in the united states could also aid our country's use of life-saving drugs to com­ bat serious illness in third world countries, such as human immunodeficien­ cy virus ("hn'') in many african nations.z6 a majority of the antiretroviral drugs which have proven successful in treating hn are bi­ ologics.27 the availability of follow-on biologics would be invaluable to african nations in their fight against the aids epidemic. a well-crafted abbreviated regulatory pathway for follow-on biologics would help alleviate the economic strain high-priced drugs place on domes­ tic and international health care systems, while encouraging the discovery of new biologics through increased competition.28 the need for generic biologics has become so great that even brand name biotech lobbyists are beginning to acknowledge the need for a practical regulatory pathway for generic forms of their drugs. the biotechnology industry organization ("bio"), a lobbying group which represents the interests of name-brand biologics manufacturers, recently conceded the necessity of follow-on bi­ ologics legislation: 22. bruce japsen, employers to shrink insurance benefits, chi. tr.m., mar. 5, 2009, at 20. 23. census report, supra note 15; letter from john taylor, supra note 7. 24. congressional budget office, budget options volume 1: health care 126 (2008), available at http://www.cbo.gov/ftpdocs/99xx/doc9925/12-18-health0ptions.pdf (last vi­ sited mar. 3, 2010). 25. jd. at 127. 26. arachu castro & michael westerhaus, how do intellectual property law and international trade agreements affect access to antiretroviral therapy?, 3 plos med. 1230, 1233-34 (2006), available at http://www.plosmedicine.org/article/info%3adoi%2f10. 1371 %2fjournal.pmed.0030332 (last visited mar. 3, 2010) (discussing united states policies addressing the need to increase treatment for mv in the u.s. and in foreign countries). 27. castro & westerhaus, supra note 26, at 1232. 28. see laurence j. kotlikoft stimulating innovation in 1he biologics industry: a balanced approach to 1\tf.arketing exclusivoy 1 (teva usa government affilirs) (2008) available at http:/lwww.kotlikoft:netlsitesldefuult/files/kotlikoff_ innovation_ in_ biologics21.pdf (last visited mar. 6, 2010) (asserting that "competition, not protection, is the 1rue source of innova­ tion and . . . overextending monopoly protection can be couiltel:producve" id ). 372 indiana health law review bio strongly supports bipartisan efforts to pass legis­ lation to create a pathway for approval of follow-on biologics this year. this issue is too important to sub­ ject to special-interest politics and misinformation campaigns. patients, employers, and public programs such as medicare have waited long enough. the time for responsible follow-on biologics legislation is 29 now. [vol. 7:367 this note will provide background information regarding biologics and their importance in our health care system. this note will then assess the position of those groups with the greatest interest in follow-on biologics legislation. finally, this note will analyze how congress should seek to strike a balance between innovation and competition in order to make af­ fordable biologics a reality. the benefits to be gained are too great, and the consequences of inaction are too dire, for further delay in the passage of effective follow-on biologics legislation. ii. background a. biologics the term "biologics" generally refers to a class of medications which are derived from living organisms using recombinant dna technology?0 although biologics are used to treat a wide range of medical conditions, they are most prevalent in the areas of immunological disease, cancer, car­ diology, gastroenterology, neurology, and others.31 the high price tag these drugs carry with them, however, present serious budgetary and regula­ tory concerns, particularlt because they are often used for long-term treat­ ment of chronic diseases. 2 for example, cerezyme, a biologic used to treat gaucher's disease, costs approximately $200,000 per patient annually?3 some of the most widely prescribed biologics (and their main use) in­ clude bristol-myers squibb's orencia (rheumatoid arthritis treatment), 29. press release, biotechnology industry organization, setting the record straight: ge­ neric drug industry lobby 'flat out wrong' about bio position on follow-on biologics (april i, 2008). available at ht1p://bio.orglnews/pressreleaseslnewsitem.asp?id=2008 _ 0401_ 02&p--yes (last visited oct. 28, 2009) [hereinafter "bio press release i'1. 30. see press release, generic pharmaceutical association, gpha statement on bio's flawed data exclusivity white paper (january 30, 2009), available at http:// www.gphaonline.org/print/media/press-releases/2009/gpha-statement-bios-flawed-data­ exclusivity-white-paper (last visited oct. 28, 2009) [hereinafter "gpha press release i"]; bio press release i, supra note 29. 31. phrma report, supra note 5, at i. 32. thomas morrow, m.d., five steps to managing biologics, 2004 biotechnology healthcare 20, 20-26. 33. health premium hikes tied to costly specialty drugs, supra note 1. 2010] follow-on biologics legislation 373 amgen's epogen (treatment of anemia arising from cancer chemotherapy), genentech's herceptin (breast cancer treatment), human insulin (diabetes management), and human growth hormone (various uses).34 the preva­ lence of these drugs, and the great potential associated with them, illustrates the urgency for comprehensive legislation to ensure affordability and en­ courage innovation. b. health care expenditures associated with biologics increasing in both number and effectiveness, prescription drugs play a significant role in our nation's $2 trillion health care system.35 currently, prescription drug expenditures comprise one-tenth of total healthcare ex­ penditures nationwide, compared with one-twentieth of health care expendi­ tures in 1980?6 biologics are being used to treat more than 800 million patients worldwide?7 according to a recent study, biologic sales world­ wide increased twelve and one-half percent in 2007, amounting to more than $75 billion, which is an increase twice as much as in chemical dru~ sales.38 spending on biologics is expected to reach $90 billion by 2009.3 the centers for medicare and medicaid services ("cms"), states that the top two anemia drugs, both biologics, accounted for 17 percent of all medi­ care part b carrier drug spending in fiscal year 2005, and two other biolog­ ics for rheumatoid arthritis and cancer accounted for an additional 13 percent of all carrier spending.40 due to tremendous advances in medicine, life expectancy in america has increased greatly, resulting in a life expectancy in the upper 70's for 34. phrma report, supra note 5, at 5, 6, 12, 23, and 26. 35. centers for medicare and medicaid services, national health expenditures ac­ counts: definitions, sources and methods 23 (2008), available at http://www. cms.hhs.gov/nationa1healthexpenddata/downloadsldsm-08.pdf (last visited mar. 4, 201 0). 36. ld . 37. biotechnology industry organization, milestones 2006: health, http://www.bio. orglspeeches/pubs/milestone06/health.asp (last visited jan. 5, 2009). 38. press release, ims health, ims health reports global biotech sales grew 12.5 percent in 2007, exceeding $75 billion (june 17, 2008), available at http://www.imshealth. com (select "press room" in top right comer, then select ''press releases" in column to left, then select "2008" from drop-down menu for year, then scroll down and select "ims health reports global biotech sales grew 12.5 percent in 2007, exceeding $75 billion" hyperlink) (last visited mar. 4, 2010). 39. the generic drng maze: speeding access to affordable, life saving drngs: hearing on 8.2300 before the s. special comm. on aging, 109th cong. 11 (2006)(statement of mark merritt. president and chief executive officer, phannaceutical care management association), available at http://www.pcmanetorglnewsroom/ju1y%20200617-20-2002/pcmao/o20finalo/o20senate"/o 20aging0/o207%20200/o2006.pdf(last visited jan. 15, 2009). 40. payment for medicare part b: hearing before h. subcomm. on health of the h. comm. on ways and means, l09th cong. (2006) (statement of herb kuhn, director, cmm), available at http://www.cn1s.hhs.gov/appslmedialpresslrelease.asp?counter=l904 (last vi­ sited mar. 4, 2010). 374 indiana health law review [vol. 7:367 americans.41 because this increase in life expectancy is often made possi­ ble·through the administration of biologic drugs over an extended period of time; the elderly population faces skyrocketing increases in health expendi­ tures. legislation allowing for an abbreviated regulatory pathway for fol­ low-on biologics should be a priority for the new administration in order to alleviate the burdens created by the prohibitive costs of these drugs. experts predict that in coming years half of all newly approved drugs will be. biologics. 42 this increase in market share will serve to exacerbate the existing financial problems stemming from these costly drugs. each new safe and effective biologic is a victory for modem medicine, but the potential of these drugs will never be realized unless they are made relative­ ly affordable.43 absent calculated measures by congress to decrease the cost of biologics, their life-saving capabilities will be available only to those fortunate enough to afford the high cost, or those with exceptional health benefits. c. competing views regardingfollow-on biologics the debate regarding whether generic biologics should be approved by fda centers around two main areas of contention: 1) whether it is feasi­ ble for generic drug companies to replicate name brand biologics safely and effectively; and 2) whether the introduction of generic biologics into the marketplace will destroy name brand drug companies' incentive to innovate by rendering the drugs unprofitable.44 ·not surprisingly, viewpoints of in­ terested parties on the viability of follow-on biologics, and the effect they would have on our nation's health care system, vary greatly.45 generic versions of chemical drugs, manufactured using precise chemical formulas, reach market through the abbreviated regulatory path­ way provided by the drug price competition and patent term restoration act, more commonly referred to as the hatch-waxman act.46 the generic 41. arialdi m. miniflo, melonie p. heron & betty l. smith. deaths: preliminary data for 2004, nat'l vital stat. rep., june 28, 2006, at 3, available aj http://www.cdc.gov/ nchs/data/nvsr/nvsr54/nvsr54 _19 .pdf (last visited mar. 6, 201 0). 42. schacht, supra note 10, at 6-8 (highlighting the efficient production of and grow­ ing need for biologics); gina kolata, co-payments go way up for drugs with high prices, n.y. times, aprill4, 2008 (discussing the fact that both medicare and private insurers now offer tier 4 plans). 43. see e.g., kolata, supra note 42. 44. see kotlikoff, supra note 28, at 4; see also e.g., gpha press release i, supra note 30; bio press release i, supra note 29. 45. compare bio press release i, supra note 29 (supporting the idea that legislation creating a regulatory pathway for follow-on biologics should require fourteen years of data exclusivity), with gpha press release i, supra note 30 (contending that exclusivity does not promote a balance between competition and innovation). 46. drug price competition and patent term restoration act, pub. l. no. 98-417, 98 stat. 1585 (1984). 2010] follow-on biologics legislation 375 legislation's congressional sponsors, senator orrin hatch and representa­ tive henry waxman, remain strong advocates of generic drugs.47 under the ~atch-waxman regulatory structure, generic drug companies are able to forgo the extensive human clinical trials brand-name druf companies must undertake to show that their drug is safe and effective.4 a generic drug company must establish that its drug it is "pharmaceutically equivalent" that is it contains the same active ingredient, in the same amount and do­ sage.49 as part of the approval process, a generic drug company must also establish its drugs' "bioequivalence" by showing that it absorbs into a pa­ tient's bloodstream at a similar rate as the brand name drug. 50 provided the generic company satisfies these, and other minor requirements, it is not re­ quired to undertake clinical studies in order to gain fda approval for their dru 51 g. the savings a generic drug company enjoys under the hatch-waxman abbreviated approval process account for the savings consumers enjoy when purchasing generic drugs. there is currently no abbreviated regulato­ ry pathway for follow-on biologics.52 consumers are still waiting for af­ fordable versions of these drugs. the biotechnology industry organization (bio), which represents the interests of leading biotechnology companies such as amgen and genen­ tech, contends that the complexity of biologics may preclude their safe dup-­ lication by generic drug companies.53 it is the general consensus among researchers that "[b]iologics differ significantly from traditional small­ molecule pharmaceuticals in their size, structural complexity, and method of manufacture."54 further, bio argues that approval of follow-on biolog­ ics would destroy the incentive to develop lifesaving drugs, as the loss in profits to generic manufacturers would render it impractical to fund neces­ sary research. 55 conversely, the generic pharmaceutical association asserts that they are capable of safely duplicating biologics, and that the resultant savings are 47. id. 48. jd. 49. id. 50. id. 51. jd 52. see u.s. food & drug admin, center for drug evaluation & research, frequently asked questions about therapeutic biological products, available at http://www/fda/gov/ cder/biologics/qa.htm (last visited mar. 6, 2010). 53. press release, biotechnology industry organization, congress must protect pa­ tient safety and promote innovation in considering follow-on biologics pathway (mar. 8, 2007), available at http://bio.org/newslpressreleases/newsitem.asp?id=2007 _ 0308 _ 01 (last visited mar. 6, 2010) [hereinafter "bio press release if1. 54. schacht, supra note i 0, at summary. 55. press release, biotechnology industry organization, bio calls for 14 years of data exclusivity in any follow-on biologics legislation (may 3, 2007), available at http://bio.org/newslpressreleaseslnewsitem.asp?id=2007 _ 0503 _ 01 (last visited mar. 6, 201 0) [hereinafter "bio press release llf1. 376 lndianahealtii law review [vol. 7:367 so significant that they should compel the enactment of legislation approv­ ing follow-on biologics. 56 some experts in this field contend that "different kinds of biologics vary considerably in their size and structure, and ... existing hatch-waxman mechanisms are appropriately applied to many biologics."57 the debate between these two powerful lobbying groups has grown more contentious over the past year, with accusations of misleading tac­ tics. 58 in an april i, 2008 press release, bio condemned the generic drug industry's lobbying groups for engaging in what it considered a gross mi­ scharacterization of bio's position on follow-on biologics. bio expressed its disappointment that, instead of engaging in a healthy discussion "based on facts and credible data, the generic drug industry's lobby keeps pushing misinformation to the news media, policymakers, and others that is flat out wrong.',s9 bio recently expressed their concerns regarding follow-on biologics through comments submitted to the federal trade commission.60 in their comments, bio ftrst expresses skepticism regarding the extent to which follow-on biologics are interchangeable with their brand-name predeces­ sors.61 it contends that "assumptions regarding ... interchangeability of [fol­ low-on biologics] in the foreseeable future are not science-based.',62 further, bio argues that allowing for "[i]nterchangeability will not neces­ sarily provide greater economic benefit.';63 the lobbying group's stance regarding data exclusivity remains that a ''period of 14 years is necessary to maintain effective market protection for innovator biologics, and thus suffi­ cient incentives for innovation.',64 notwithstanding these serious reserva­ tions regarding follow-on biologics, bio contends that legislation addressing follow-on biologics would be appropriate if it allows for jroper "incentives for continued development of next-generation products.' the primary incentive for innovation that bio seeks is assurance that itwill be provided what it deems as sufficiently lengthy data exclusivity protection fourteen years.66 this protection, the organization argues, is "important for advancement of medical treatment and would not prevent fob market en­ try.',67 56. gpha press release i, supra note 30. 57. schacht, supra note 10, at summary. 58. see e.g., bio press release i, supra note 29. 59. /d. 60. letter from john taylor, supra note 7. 61. id 62. id 63. ·jd 64. id 65. letter from john taylor, supra note 7. 66. id 67. id. 2010] follow-on biologics legislation 377 it would be a significant victory for brand name drug manufacturers if follow-on· biologics legislation were to include provisions precluding bi­ ologics from the presumed substitutability and interchangeability chemical generic drugs enjoy under the hatch-waxman act.68 bio argues that rec­ ognition of substitutability and interchangeability for biologics would un­ dermine the physician's discretion in prescribing which biologic to take, because "[n]o two biologics are identical and some differences could have clinical implications that are not known at the time of approva1.',69 concur­ ring with bio on this issue, the american medical association passed a resolution committing to ''work with the u.s. food and drug administra­ tion and other scientific and clinical organizations to ensure that any legisla­ tion that establishes an approval pathway for follow-on biological products prohibits the automatic substitution of biosimilar medicines without the consent of the patient's treating physician.''70 bio highlights other countries' approach to substitutability and inter­ changeability in their treatment of follow-on biologics.71 for example, united kingdom government officials have stated, "when prescribing bio­ logical products, it is good practice to use the brand name. this will ensure that automatic substitution of a biosimilar ~uct does not occur when the medicine is dispensed by the pharmacist.'' 2 french authorities have also noted, "a systematic and uncontrolled substitution, based on the prescription of the international common denomination of the active substance, does not appear reasonable at this time ... physicians should be involved in deci­ sions to substitute any bmp [biological medicinal product].'.73 bio further asserts that a finding of interchangeability will not neces­ sarily result in greater savings to consumers. 74 other factors, they argue, may have a greater effect on the extent to which consmners actually save: the degree of competition and potential cost savings arising from a follow-on biologics approval pathway is likely to be heavily dependent on numerous factors beyond the question of interchangeability, including number· of market entrants, product quality, cost of production, price discounting, market penetration, po68. drug price competition and patent term restoration act, pub. l. no. 98-417, 98 stat. 1585 (1984); letter from john taylor, supra note 7 .. 69. letter from john taylor, supra note 7. 70. id. 71. /d. 72. jd. (citing mhra drug safety update: vol. 1, issue 7 (feb. 2008), available at http://www.mhra.gov.uk/publications/safetyguidance/drug safetyupdate/con2033917). 73. id. (citing pavlovic et al; similar biological medicinal products containing re­ combinant human growth hormone: european regulation; hormone research; 2008; 69; 14-21). 74. biotechnology industry organization, supra note 8. 378 indiana healrn law review . [vol. 7:367 tential market size for any given product, etc. indeed, a finding of interchangeability may in fact lead to . lower savings to consumers, depending on its impact on these other critical factors. bio therefore believes it would [be] imprudent for the ftc to rely on erro­ neous scientific and economic assumptions i.e., that interchangeability is·likely and would necessarily -lead· to greater cost savings in crafting any public policy recommendations relating to a fobs regime. 75 d. degrees of exclusivity granted to innovators by generic legislation , laws granting generic manufacturers the right to duplicate brand name drugs typically allow the original manufacturer a term of exclusivity, during which the original manufacturer is able to profit from its innovation without having to compete with less expensive generics.76 exclusivity is granted in two forms data exclusivity and approval exclusivity (market exclusivity).17 data exclusivity in this context typically refers to statutory prohibition. of the approval for a generic product which uses an innovator product as its reference product. 78 . a data exclusivity period is the time during which a potential generic supplier of a given drug is barred from submitting an abbreviated new drug application ("anda").79 an anda allows generic companies to save the time and expense of the extensive clinical trials required for the approval of an entirely new drug. 80 ·during a data exclusivity period, the fda may not use the innovator's safety and effectiveness data as a basis for approving a generic alternative.81 approval exclusivity, often termed market exclusivity, refers to the pe­ riod during which a drug supplier is free to file their anda using the brand company's safety and effectiveness data, but cannot receive approval.82 initially, the distinction between these two types of approval seems trivial­ being barred from filing for approval under data exclusivity, and being per75. id. 76. drug price competition and patent term restoration act. pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 77. schacht, supra note 10, at 12-13; drug price competition and patent term resto­ ration act. pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). . 78. schacht, supra note 10, at 13; drug price competition and patent term restora­ tion act. pub. l. no. 98-417 (1984), 98 stat.l585 (1984). 79. u.s. food and drug admin., abbreviated drug application (anda): generics, http://www.fda.gov/drugs/deve1opmentapprova1process/howdrugsaredevelopedandappro ved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.htm (last visited jan. 13, 2009). 80. id. 81. id. 82. kotlikoff, supra note 28, at 6. 2010] follow-on biologics legislation 379 mitted to file but precluded from approval under approval exclusivity. however, the two types of exclusivity have a very practical effect on the degree of monopoly they grant.83 generic drug suppliers are only able to challenge the patents of brand name counterparts if they have filed for fda approva1.84 under· data exclusivity, even patents which would be found invalid underjudicial review are immune to competitors' challenges.85 bio consistently contends that fourteen years of data exclusivity, es­ sentially comflete monopoly, is necessary in order to maintain the incentive to innovate. 8 "biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time in order to secure the necessary resources from venture capital firms and other funding sources."87 bio further, expresses· its concern that an "uncertain 'similarity" standard with respect to biologics will create "a greater potential for biologic patents to be designed around, particularly given some of the available case law involv­ ing the scope of biologic patents."88 bio claims these uncertain standards will result in difficulty justifying commitment of the resources necessary to ·bring a biologic to market "[b]ecause fobs will not have to comply with rigorous 'sameness' standards for traditional pharmaceutical gener­ ics ... [thus,] biologics patent portfolios will not provide the same level of certainty for innovators and investors as patents do for traditional pharma­ ceuticals againstpremature generic entry."89 to illustrate the validity of their stance on data exclusivi~, bio cites a 1990 case involving two leading biotechnology companies.9 there, ge­ nentech was sued·by hormone research foundation in a dispute regarding its recombinant human growth hormone product.91 the accused ·product, manufactured by genentech, differed from hormone research f ounda­ tion's patented human growth hormone product by only two amino acids. notwithstanding the near identical nature of the products, the u.s. court of appeals for the federal circuit found that hormone research foundation's patent did not cover the accused product.92 . bio's statement contains a narrow, and perhaps even misleading view, of the genentech decision. the court implies that if it were not for limiting language in hormone research foundation's patent, the genentech 83. see e.g., schacht, supra note 10, at 13-14. 84. id. at 14. 85. /d. 86. letter from john taylor, supra note 7. 87. id. 88. /d. 89. /d. 90. letter from john taylor, supra note 7 (citing hormone res. found. v. genentech, 904 f.2d 1558 (fed. cir. 1990)). 91. letter from john taylor, supra note 7. 92. honnone res. found. v. genentech, 904 f.2d 1558 (fed. cir. 1990). 380 indiana heal til law review [vol. 7:367 product rna~ have been found to be infringing based on the doctrine of equivalents. 3 concern that biologics. man:ufacturej.:s may have over the stability of theit patents should be mitigated by the. doctrine of equivalents, an equitable doctrine intended ''in situations where there is no literal in­ fringement but liability is nevertheless appropriate[,] to prevent what is in essence a pirating of the patentee's invention."94 under this doctrine, a product may infringe an existing patent if it performs "substantially the same function in substantially the same way to give substantially the same result."95 so, while brand dame manufacturers' concern regarding the simi­ larity requirement for generic biologics is not unreasonable, it may be over­ stated: it is important to note that exclusivity right$ are entirely separate from patent protection.96 these types of protection are not on the same timetable ~ exclusivity periods begin with fda approval of the brand drug, whereas patent protection begins after the new discovery is made and a patent appli­ cation is approved by the united states patent and trademark office.97 ''the upshot here is that if the total period of. exclusivity exceeds the amount of patent protection left at the time of fda nda approval, mono­ poly protection will be expanded by the number of years that exclusivity exceeds remaining patent life."98 1. general agreement on tariffs and trade (ga1t) some legislation allow~; for innovators to evergreen its drugs. ever­ greening refers to the process whereby patent holders use the time afforded by initial monopoly protection to make minor modifications to the biologics formulation in order to gamer extended periods of exclusivity. 99 when pursuing this strategy, innovators make changes which are significant enough to lengthen statutory exclusivity, but not so significant that they affect a drug's function or require extensive investment. some trivial mod­ ifications typically made in an effort to evergreen drugs include the follow­ ing: changing the medication strength of pills (e.g., chang­ ing the pills from .1 0 mg to .15 mg), changing the form of medication (e.g., switching from pill to cap93. genentech, 904 f.2d at 1564. 94. loctite corp v. ultra-seal ltd., 781 f.2d 861,870 (fed. cir.l985). 95. /d. 96. drug price competition and patent term restoration act, pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 97. /d. 98. kotlikoff, supra note 28, at 6. 99. id at9. 2010] follow~on biologics legislation sule ), modifying the method of delivery (e.g., from in­ jection to inhalation), expanding indications (applying the medicine to additional conditions), pegylation (which has the effect of reducing doses per time pe­ riod via time-release mechanisms), and glycosolation (adding sugar molecules to the medication ).1 00 381 the existence of these provisions, as well as the varying degrees of latitude they give innovators to extend their monopoly, is important when assessing the fairness of proposed legislation. 2. the inhibitory effect of exclusivity provisions on innovation innovators build on others' achievements in making new discoveries. sir isaac newton referred to this age-old process, stating "[i]f i have seen further it is by standing on ye shoulders of giants.''101 any policy which effectively lengthens the time between innovations may result in decreased innovation over time. decreased innovation in general has a profound ef­ fect on our economy, but decreased innovation of life-saving drugs reaches much further than the bottom line it negatively impacts our health. once a drug company has received approval for a blockbuster biologic, the com­ pany is typically less inclined to promote discovery of new drugs to the same extent it had prior to approval of that drug. "[y]esterday's inventors are much less likely to be either today's innovators or tomorrow's."102 once an innovator has made a discovery, he or she is faced with different incentives than those that may have prompted the discovery. the brand company diverts resources from innovation towards building and sustaining the profitability of its new discovery. consider for example, genetico, a hypothetical biologics manufac­ turer which spends millions of dollars to make an initial discovery of a pro­ tein-based compound which can be developed into a lifesaving cancer drug. after the discovery is made, genetico's main goals include protecting this intellectual property, developing the drug, conducting clinical trials, gaining fda approval for the drug; and finally manufacturing, marketing, and sell­ ing the drug. these goals do not coincide with the devotion of significant resources towards building on the discovery. if genetico were to build on the discovery and essentially produce a better version of the current prod100. id 101. letter from sir isaac newton to robert hooke (feb. 15, 1676). this letter was originally dated feb. 5, 1675 using the julian calendar with march 25th rather than january 1st as new years day. according to gregorian theorists, the original date is equivalent to feb. 15, 1676. 102. kotlikoff, supra note 28, at 4. 382 indiana heal1h law review. [vol. 7:367 uct, it would be diminishing much of the value of the initial invention.103 many economists have concurred with nobellaureate kenneth ar­ row's contention that ''the incentive to invent is less ·under monopolistic than under competitive conditions!'104 monopolists are less likely to inno­ vate for a simple, though not necessarily obvious reason:, if a company in­ troduces an improved version of their existing product into the market they diminish their own revenue on their existing product. so long· as a particu­ lar product is the only option for consumers, brand companies have no in­ centive to expend resources in an effort to improve their own product. as· expiration of the monopoly approaches and the prospect of competition re­ surfaces, the wheels of innovation begin to churn again as the· original inno­ vator and hopeful competitors strive to produce the superior version of a product. of course, brand name drug companies need to be provided assurance that they will not only be able to recoup their investment in a given drug, but that the drug will be profitable. when these companies are afforded monopolies for time periods beyond what is necessary, however, the sacri­ fice in innovation and increased c~st become more difficult to justify. ap­ propriate .. legislation will·· limit monopoly protection for biologics manufacturers to the length necessary to· maintain the incentive to. discover new drugs. 3. access distortion the high price ofbiologics, coupled with the increasing number of un­ insured and underinsured americans,· results in distorted access: those for­ tunate enough to have access to these drugs may not ·have the greatest need.105 aside from the obvious equity issues associated with this access distortion, efficiency concerns exist as well. · · markets in which some people face one set of prices for goods and services and other people face another set are inefficient for a simple reason .,.. there are bene­ ficial economic trades between the two sets of people that are not occurring *** concern about these efficiency costs explains why we 103. /d. at 4-5 (discussing mechanisms by which a biologics manufacturer prolongs its monopoly). 104. kenneth j. arrow, economic welfare and the allocation of resources for inven­ tion (rand corp. working paper no. p-1856-rc, 1959). 105. kotlikoff, supra note 28, at 5. 2010] follow-on biologics legislation restrict monopolies, why we have patent limits, why we have free domestic trade, and why we form free trade agreements. 106 383 excessively lengthy protection monopolies enjoyed by name-brand biolog­ ics manufacturers result in decreased competition and in inefficient delivery of biologics to patients. 4. hatch-waxman actvery limited exclusivity generic drugs are "identical, or bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. "1 07 a. potential savings associated with follow-on biologics. proponents of lengthy exclusivity provisions assert that such provi-' sions are essential to ensure profitability as an incentive to innovate.108 conversely, some economists contend that lengthy exclusivity periods pose a serious threat to innovation. 109 the latter of these views militates in favor of applying a modified version of the hatch-waxman act, with its limited exclusivity, to promote biologic competition and innovation.110 "[t]he effects ofwaxman-hatch and gatt on [effective patent life] have been modest to date."n 1 while the hatch-waxman act does grant data and approval exclusivity for chemical-based drugs, this exclusivity is very limited compared to the provisions in many of the proposed biogenetic bills before congress.112 106. !d. instead of the combined data plus approvalexclusivi­ ty periods of twelve years (four data plus eight ap­ proval) years proposed in the kennedy bill and fourteen years (twelve data and two approval) pro­ posed in both the eshoo-barton and inslee follow-on 107. u.s. food and drug admin., generic drugs: questions and answers, http://www.fda.gov/drugs/resroucesforyour/consumerslquestionsanswerslucml 00 i oo.htm (last visited oct. 21, 2009). 108. drug price competition and patent term restoration act, pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 109. kotlikoff, supra note 28, at 4. 110. see generally drug price competition and patent term restoration act, pub. l. no. 98-417, 98 stat. 1585 (1984). ill. henry g. grabowski and john m. vernon, effective patent life in pharmaceuti­ cals, 19 int'lj. tech. mm.p". 98, 116 (2000). 112. drug price com~tition and patent tenn restoration act, pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 384 indiana heal til law review biologics bills, hatch-waxman offers five years of exclusivity generally, with four years of data exclu­ sivity followed by one year of approval exclusivity if an applicant files. a patent challenge in the fourth year. the waxman follow-on biologics bill does not ad­ dress data or approval exclusivity whatsoever.113 [vol. 7:367 "the hatch-waxman act also provides forpatent restoration; the act restores to a new chemical entity's patent life half of the time spent in clini­ cal testing .and all of the time spent securing fda approval, up to a maxi­ mum of five years."114 a result of hatch-waxman's patent restoration provision is that the exclusivi7,_provision is not likely to extend the total length of monopoly protection. 1 the exclusivity provision, however, does serve to delai competitors' ability to contest innovators' patents by at least four years.11 the hatch-waxman act has saved americans billions of dollars in prescription drug expensesy7 generic drugs provide safe and effective alternatives to their name brand counterparts, and often cost eighty percent less.u8 · b. hatch-waxman's effect on follow-on biologics there is· one provision of the hatch-waxman act, patent-term restora­ tion, which currently applies to biologics as well as chemical drugs} 19 un­ fortunately, this provision does not yet have any substantive force because there is currentltc no regulatory pathway for follow-on biologics to receive fda approval.1 0 since none of the proposed bills121 would affect this por­ tion of the ·hatch-waxman act, brand name drug companies would still receive significant protection of their patents through ~·four legislated types of monopoly protection gatt, data exclusivity, approval exclusivity, and patent restoration. each of these protections can impact the total length of monopoly protection depending on the particular circumstances involved. under. the waxman bill, brand biologics would enjoy gatt and patent res113. id. 114. kotlikoff, supra note 28, at 6. 115. see e.g., grabowski and vernon, supra note ll1, at ll6 (stating that the hatch­ waxman act's effect on patent life has been "modest''). 116. drug price competition and patent term restoration act, pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 117. alan j. morrison, biosimilars in the united states: a brief look at where we are and the road ahead, 26 biotechnolooy l. rep. 463, 464 (2007) (citation omitted). 118. id. 119. drug price competition and patent term restoration act, pub. l .. no. 98-417 (1984), 98 stat. 1585 (1984). 120. ld 121. see e.g., biologics price competition and innovation act of2007, s. 1695, 110th cong. (2007). 2010] follow-on biologics legislation 385 toration protections."122 three of the four biogenetic bills entail expansion of monopoly pro­ tection for biologics.123 because new innovators rely on pre-existing scien­ tific advances, the extension of monopoly protection has an exponential deleterious effect. for example, increasing monopoly protection from twenty to twenty-five years results in a twenty-five percent delay in the on­ set of the next innovation. 124 in this case, the second innovation arrives five years late, the third 1 0 years late, the fourth 15 years late, the third 1 0 years late, the fourth 15 years late, etc. over the course of a century, the country experiences not five innovations, but four."125 the decision to permanently extend monopoly protection has far greater consequences as time progresses, causing a greater decrease in innovation with each succes­ sive generation. e. proposed legislation all of the proposed legislation purports to allow for e~enditure relief for the public while protecting the innovator's interests.12 these abbre­ viated regulatory procedures would allow the manufacturers of follow-on biologics "to sell the competing version at a discounted price by avoiding the substantial research and development expenses incurred by the brand­ name company to bring an innovator biological product to market, includ­ ing costs associated with large, clinical trials necessary to demonstrate safe­ ty and effectiveness of the treatment in humans. "127 the bipartisan biologics price competition and innovation act of 2007, introduced by senator ted kennedy (d, mass.), would provide inno­ vators twelve years of exclusivity and allow interchangeability upon the satisfaction of certain requirements.128 once a drug is classified as inter­ changeable, a generic drug can be substituted for the original without phy­ sician approval. 129 in june 2008, the congressional budget office released findings that reflected this bill would save an estimated $25.2 billion in bi­ ologic drug spending over ten years. in its report, the cbo estimates that: 122. kotlikoff, supra note 28, at 6-7. 123. id. at 7. 124. id 125. id. 126. see generally, pathway for biosimilars act, h.r. 5629, i 10th cong. (2008). 127. congressional budget office, cost estimate: s. 1695 -biologics price competition and innovation act of 2007 4 (2008), available at http://www.cbo.gov/ ftpdocs/94xx/doc 9496/sl695.pdf (last visited mar. 7, 2010) [hereinafter "cbo cost estimate"]. 128. biologics price competition and innovation act of 2007, 8.1695, i loth cong. §7(a) (2007). 129. s. 1695. 386 indiana health law review • enacting s. 1695 would reduce total expenditures on biologics in the united states by $0.2 billion over the 2009-2013 period and by about $25 billion over the 2009-2018 period. (over that 10-year period, such savings would equal roughly 0.5 percent of national spendinft on prescription drugs, valued at wholesale prices.) 0 • direct spending by the federal government would decrease by $46 million over the 2009-2013 period, and by $5.9 billion over the 2009-2018 period. feder­ al revenues would increase by $6 million over the 2009-2013 period and by $0.8 billion over the 20092018 period. as a result of those changes, cbo esti­ mates that enacting the bill would reduce budget defi­ cits (or increase surpluses) by a total of $52 million over the2009-2013 ~riod and by $6.6 billion over the 2009-2018 period.1 i • implementing s. 1695 would increase federal dis­ cretionary costs, on net, by nearly $30 million over the 2009-2013 period and by $5.3 billion over the 2009-2018 period, assuming appropriation of the ne­ cessary amounts, mostly because the bill w.ould au­ thorize discretionary spending equal to the estimated amount of savings to the federal government under the legislation. these sums exclude fda's costs to administer the new regulatory program established under the bill.132 [vol. 7:367 the bill would also significantly decrease medicaid expenditures. "cbo estimates that state spending for medicaid would decrease by about $4 bil­ lion over the 2009-2013 period."133 bio is a proponent of the pathway for biosimilars act (h.r. 5629), in1roduced in march of2008 by reps. anna eshoo (d, calif.) and joe bar­ ton (r, texas).134 this bill would provide innovators twelve years of ex­ clusivity, and a possible two-year extension if a newly approved use of the drug is discovered.135 bio contends that fourteen years of exclusivity is 130. cbo cost estimate, supra note 127, at 1. 131. id. 132. id. at 2. 133. id. at 10. 134. doug trapp, disagreements slow progress on biogenerics legislation, american medical news, aug. 11, 2008, http://www.ama-assn.orglamednewsl2008/08/11/gvsa0811. htm (last visited mar. 6, 20 i 0). 135. id. 2010] ' follow-on biologics legislation 387 necessary to maintain the requisite incentives to research and develop new biologics.136 the generic pharmaceutical association ("gpha") opposes the pathway for biosimilars act. 137 gpha spokeswoman andrea hofelich stated that this legislation is "will needlessly delay affordable. lifesaving biogenerics form getting to [patients]."138 the most imgortant of these roadblocks is the potential of fourteen years of exclusivity. 39 this lengthy monopoly protection is in stark contrast to the five years of exclusivity chemical drugs are afforded under hatch-waxman.140 "the eshoo-barton legislation has been endorsed by the pharmaceuti­ cal research and manufacturers of america and the [association] of amer­ ican universities."141 the gpha prefers the promoting innovation and access to life-saving medicine act, sponsored by representative henry waxman.142 this bill is very similar to the hatch-waxman act, and would require similar steps to be taken for biogeneric approval as would be taken for chemical generic drug approval. 143 proponents of the promoting inno­ vation and access to life-saving medicine act cite a 2007 study by duke university economist henry grabowski which concluded that the average time to develop a new biologic was 97.7 months, while the development of new chemical drugs averaged 90.3 months.144 gpha asserts that this is not a significantly different timetable, and that regulation of follow-on biolog­ ics should closely mirror that of chemical generic drugs. 145 f. shorter exclusivity periods may actually promote innovation. a recent study by dr. laurence j. kotlikoff, professor of economics at boston university, suggests that length exclusivity projections for manu­ facturers of biologics not only results in these drugs' high price, but also 136. letter from john taylor, supra note 7. 13 7. press release, the generic pharmaceutical association, gpha says new study shows that hatch-waxman is a successful model for biogenerics legislation exclusivity provisions similar to those in hatch-waxman would promote competition and innovation (september 17, 2008), available at ht1p://www.gphaonline.org/media/press-releases/2009/02/12/gpha-says-new­ study-shows-hatch-waxman-successful-model-biogenerics(last visited mar. 7, 201 0) [hereinafter "gpha press release ii"]. 138. !d. 139. h.r. 5629, §7(a). 140. drug price competition and patent term restoration act, pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 141. trapp, supra note 134. 142. id 143. see promoting innovation and access to life-saving medicine act, h.r. 1427, ill th con g. (2009). this piece of legislation was first introduced on march 11, 2007 and was entitled the access to life-saving medicine act. it was later modified to its current form. 144. henry grabowski, follow-on biologics: data exclusivity and the balance be­ tween innovation and competition, 7 nature reviews: drug discovery 4 79, 481 (2008). 145. gpha press release ii, supra note 13 7. 388 indiana health law review actually stifles innovation: four bills pending in congress propose to do for bi­ ologic medications what the 1984 landmark hatch­ waxman bill did for chemical medications, namely, promote a competitive marketplace that would dra­ matically lower prices while also ensuring strong in­ centives to innovate. yet three of the four bills contain exclusivity provisions that run the danger of overextending monopoly protection. doing so would, paradoxically, undermine innovation and the bills' own objectives. bestowing lengthy monopolies by statute on brand biologic companies not only greatly delays entry by competitors with low-cost alterna­ tives, but also excludes other innovators from build­ ing in a timely manner on the stock of prior knowledge much of which was accumulated at bl. 146 pu tc expense. [vol. 7:367 this study represents a favorable viewpoint for generic manufacturers. while it is readily apparent that lengthy exclusivity periods allow manufac­ turers' to charge higher prices, the observation that these monopolies may actually inhibit innovation is much less obvious.147 dr. kotlikoff contends that "competition, not protection, is the true source of innovation and that overextending monopoly protection can be counterproductive."148 "this is particularly true given the potential to use exclusivity periods to 'evergreen' one's productsto secure additional long periods of monopoly based on minor product modifications."149 dr. kotlikoff cites the success of the hatch-waxman act in balancing innovation with affordability, as well as the "absence of any material differ­ ences between the biologics and chemical medical industries arguing for longer monopoly protection," when recommending that congress "consider the hatch-waxman model for exclusivity rather than proposals that would distort the market and undercut innovation."150 1. the generic pharmaceutical association's response to the kotlikoff study: gpha endorsed the findings of dr. kotlikoff's study in a september 146. kotlikoff, supra note 28, at 1. 147. /d. 148. /d. 149. /d. 150. /d. 2010] follow-on biologics legislation 389 17, 2008 press release}51 kathleen jaeger, president and ceo of gpha stated: dr. kotlikoffs economic analysis strongly supports the value of biogenetic competition. first, creating an approval pathway for biogenetic competition will create substantial savings for struggling consumers, and a challenged economy. our nation needs to deliv­ er these savings today, for those who n~d, but cannot afford expensive biologic medicines . . . . second, ba­ lancing brand exclusivity and rewarding innovation, while permitting generic competition, is simply good medicine for our healthcare system. for nearly 25 years, hatch-waxman has demonstrated that when competition for pharmaceutical products exists from generics, the marketplace incentive to create new products with exclusivity spurs innovation. dr. kotli­ koff s study notes that 'research and development in pharmaceuticals, measured relative to sales, increased dramatically after 1984' and further notes that 'nce approvals increased by one-third in the decade fol­ lowing the bill's (hatch-waxman) passage.' these statistics clearly show that competition is good for in­ novation . . . . third, excessive market exclusivity or the ability to evergreen products poses a significant risk to innovation. dr. kotlikoffs study states that 'over-extending monopoly protection... may do little or nothing to incentivize new discovery and simply delay when the next discovery comes on board.' gpha believes that a vibrant biopharmaceutical in­ dustry, with the incentive to create new medicines, is pro-consumer and pro-healthcare. without the incen­ tive that competition from generics will create to de­ velop new and more innovative products, patients suffer.152 gpha strongly supports dr. kotlikoff's conclusion that excessive ex­ clusivity 'reduces the pace of innovation', and that exclusivity provisions similar to those applied to chemical drugs through the hatch-waxman act3 provide sufficient incentive to innovate while encouraging competition.15 151. gpha press release ll, supra note 137. 152. !d. 153. ld 390 indiana health law review [vol. 7:367 gpha ·contends that excessive exclusivity results in harm to the consumer by limiting access to affordable biogenerics and by decreasing the ·likelih­ ood of new innovator products being introduced due to increased competi­ tion.154 gpha notes the growing support for biogenerics legislation, stating that ''[n]early 70 organizations representing tens of millions of americans, including aarp, major corporations like gm and caterpillar, the consum­ er federation of america, the afl-cio and more than 20 state governors support the creation of a pathway for biogenerics. "155 · in a press release, bio argues that an approval pathway for follow-on biologics should include a fourteen year period of data exclusivity. to en­ courage investment in biopharmaceuticals and promote the development of new therapies.156 biologics research and development entails higher costs, longer development times, and lower late-stage success rates than small­ molecule drugs. 157 the majority of biopharmaceutical companies are small startups, and an appropriate period of data exclusivity would encourage the venture-capital investment that these companies need, according to the statement. 158 iii. analysis: modified version of hatch-waxman applicable to biologics a. downfalls of proposed biogenerics bills remarkably, the kennedy, eshoo-barton, and inslee bills reward delay in getting to market with longer monopoly protection, with each year of delay beyond twelve leading to roughly one more year of protec­ tion.· one wonders why legislators would want to en­ courage delay in the pace at which innovative drugs are brought to market and lower the speed at which today's innovations are incorporated in tomorrow's discoveries.159 . conversely, the hatch-waxman and waxman biologics bills discourage "delays in reaching the market b~ reducing monopoly protection by roughly one year for each year of delay." 60 proponents of increased monopoly protection for biologics compared 154. id 155. id 156. bio press release i, supra note 29. 157. bio press release ii, supra note 53. 158. bio press release iii, supra note 55. 159. kotlikoft supra note 28, at 8. 160. /d. 2010] follow-on biologics legislation 391 to chemical drugs contend that the longer time necessary for development of biologics justifies extended protection.161 while this argument has some merit, the increase in monopoly protection of biologics over chemical drugs should closely correlate to the difference in time it takes to develop biolog­ ics than chemical drug development. biolo:fics take on average 7.4 months longer to develop than chemical entities.16 the eshoo-barton and inslee bills go well beyond compensating for this increased development time, providing innovators between 12 months and 120 months of extra monopo­ ly protection the variance is based on when the biologic is brought to market.l63 1. cost/risk justification argument the costs associated with introducing a new biologic into the market total an estimated $1.24 billion.164 while this figure is staggering by any standard, it cannot be looked at alone. the cost must be put into appropri­ ate context and should be compared to the potential return on the invest­ ment. "invention x may cost $1 million to bring to market and invention y $1 billion, but the projected revenues for y may exceed those for x by far more than a factor of 1,000. in this case, less monopoly protection is needed to promote invention ofy than ofx."165 b. the hatch-waxman act should be used as a template for generic bi­ ologics legislation. opponents of generic biologics contend that allowing generic produc­ tion of these drugs will stifle innovation. 166 the hatch-waxman act is proof that generics do not stifle innovation, in fact they stimulate innovat . 167 ton. hatch-waxman's success did not come at the price of innovation. on the contrary, the legislation appears to have accelerated innovation . . . . research and de­ velopment in pharmaceuticals, measured relative to sales, increased dramatically in the years after 1984. 161. letter from john taylor, supra note 7. 162. grabowski, supra note 144, at 481. 163. s. 1695, supra note 122; h.r. 5629, supra note 126. 164. see kotlikoff, supra note 28, at 8 (citing joseph a. dimasi, ronald w. hansen, and henry g. grabowski, the price of innovation: new estimates of drug development costs, 22 j.healthecon.151, 151-185 (2003)); grabowski, supra note 144, at482. 165. kotlikoff, supra note 28, at 9. 166. letter from john taylor, supra note 7. 167. drug price competition and patent term restoration act, pub. l. no. 98-417 (1984), 98 stat. 1585 (1984). 392 indiana health law review r&d is now running between 16 percent and 18 per­ cent of sales, on an annual basis, compared with 8-10 percent of sales prior to hatch-waxman. *** [t]he number of new drug patents issued by the u.s. patent office rose dramatically after 1984 and, in­ deed, has exceeded the pre-1984 levels in each year since the act was promulgated.168 [vol. 7:367 any reduction in profitability of developing new drugs as a result ofhatch­ w axman was mitigated by other factors, including an increased reliance on medication in health care, increased demand resulting from an aging socie­ ty, and an increased international demand as a result of greater parity amongst industrial nations. "for all drugs, on average, the increase in ge­ neric sales since 1984 bas probably not reduced expected returns below the average capitalized costs of r&d. on the margin, however, it is possible that a few dru£s that were barely profitable to develop before may no longer be so now."1 while generic drugs comprise a large portion of all pre­ scriptions filled in the u.s.; the brand companies' annual revenue, over a quarter of a trillion dollars in 2007,170 represents eighty;. four percent of all h . 1 171 p armaceuttca revenue. c. congress should assess the arguments from these two inherently bi­ ased groups with a focus on our country's biotech consumers this debate centers around the feasibility of safe and effective dupli­ cation of biologics, and the effect that an abbreviated regulatory pathway for follow-on biologics will have on innovation. congress and fda should assess these areas of contention impartially, and take action commensurate with the urgency of this highly important issue. the threshold question should be whether biologics are amenable to safe duplication.172 if they are, then follow-on biologics legislation should be enacted which strikes a balance between the necessary encouragement of innovation, and eventual relief to patients' pocketbooks. 168. kotlikoff, supra note 28, at 10. 169. kotlikoff, supra note 28, at ll(quoting congressional budget office, study: how increased competition from generic drugs has affected prices and returns in the pharmaceutical industry ( 1998) ). 170. generic pharmaceutical association, facts at a glance, http://www.gphaonline. org!about-gphalabout-generics/facts (last visited mar. 11, 2010). 171. ims health, "ims national prescription audit plus, national sales perspectives," december 2007. 172. gpha press release ll, supra note 137. 2010] follow-on biologics legislation 393 an independent research panel should be used to assess the true exclu­ sivity period necessary for biotech companies to turn a profit on a given drug. this data should be compared to corresponding data pertaining to chemical drugs, and a bill similar to the hatch-waxman act should be con­ structed which reflects any differences in the data. while a biologic may be more expensive to produce, there is no reason why congress should be precluded from constructing a modified version of the hatch-waxman act, provided generic companies prove that they are capable of safely reproduc. th dru 173 mg ese gs. president barack obama has stated that he will seek to establish a regulatory pathway for generic biologic drugs as part of his health care reform plan.174 in his budget report for fiscal year 2010, president obama acknowledges that "[p]rescription drug costs are high and rising, causing too many·americans to skip doses, split pills, or not take needed medication altogether."175 in an effort to expand access to affordable biologic drugs, the administration plans to establish "a workable regulatory, scientific, and legal pathway for generic versions of biologic drugs."176 though few de­ tails are provided, president obama's budget report states that the admin­ istration will retain the necessary incentives for innovation by providing "a period of exclusivity ... generally consistent with the principles in the hatch-waxman law for traditional products."177 the administration also addressed the problem of ever-greening, stating that brand biologic manu­ facturers will be ''prohibited from reformulating existing products into new products to restart the exclusivity process."178 it is encouraging that the obama administration plans on addressing the problem posed by the high cost of biologics, but the contentious debate over what type of legislation is most appropriate will continue until a re­ sponsible compromise is met. the administration's plan to allow for ex­ clusivity of biologics "generally consistent with the ... hatch-waxman [act]"179 may be too ambitious when considering the arguably compelling points of biologics manufacturers that the greater complexity of biologics, and the more substantial investment necessary to bring such drugs to market necessitates a longer period of exclusivity. if responsible biologics legisla­ tion is given appropriate attention in congress, then a healthy compromise is realistic. using the hatch-waxman model as a template, appropriate concessions should be made to account for the increased complexity and 173. office of mgmt. and budget, executive office of the president, a new era of responsibility: renewing america's promise 28 (2009) [hereinafter" a new era"). 174. id. 175. id. 176. id. 177. id. 178. a new era, supra note 174, at 28. 179. id. 394 indiana health law review [vol. 7:367 expense involved in bringing a biologic to market. d. biogeneric legislation as a catalyst for innovation. creative destruction is a term used to refer to the cycle of innovation which is made possible by each innovation building on a prior innova­ tion.180 economic progress, in capitalist society, means tur­ moil. [what counts is] competition from the new commodity, the new technology~ the new source of supply, the new type of organization ... competition which ... strikes not at the margins of the profits and the outputs of the existin/i firms, but at their founda­ tions and their very lives. 1 *** [e]ach innovation is part of a chain. today's innova­ tion cannot proceed if yesterday's is not accessible. and tomorrow's innovation must wait until today's innovation is available for use. moreover, if the cur­ rent length of monopoly protection suffices to incen­ tivize today's innovation, extending the length of protection will do nothing to increase current innova­ tion with the economy, over time, falling further and further behind with respect to the level of technology it would otherwise have available.182 e. economic/welfare implications cost savings can be achieved by biogenerics industry. in fact, "[r]ecent research suggests such an industry would save the american pub­ lic at least $25 billion and as much as $108 billion over the next decade and greater sums thereafter from biogenerics legislation that properly limits the duration of monopoly protection.''183 a recent new york times article 180. kotlikoff, supra note 28, at 14 (citing joseph a. schumpeter, capitalism, socialism, and democracy {harper & row 3d ed. 1950) (1942)). 181. !d. 182. kotlikoff, supra note 28, at 14. 183. !d. at 12-13 (teva usa government affairs 2008)( citing congressional budget office, cost estimate: s. 1695-biologics price competition and innovation act of 2007 (2008) and robert j. shapiro, the potential american market for generic biological treatments and the associated cost savings (february 2008)). 2010] follow-on biologics legislation reported that [h]ealth insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dol­ lars for prescriptions [and] medications that may save their lives or slow the progress of serious diseas­ es ... [t]he system means that the burden of ex~ensive health care can now affect insured people, too. 84 395 f. exclusivity provisions should allow for abbreviated periods of monopoly protection. competition, not protection, is the best tool to drive innovation.185 as dr. kotlikoff asserted in his assessment of how to best promote biologics innovation, ''the new drugs of today are not those of tomorrow ... inventors have strong incentives to protect their discoveries, not to make new ones whose arrival on the market would undermine their existing profits." 186 while longer periods of monopoly will allow innovators to turn a greater profit per innovation, this longevity of ~rofitability of one discovery may actually delay subsequent discoveries.1 the delay of discoveries, or at least the revelation of these discoveries, results in less total life-saving dis­ coveries over time.188 effective legislation will seek to minimize evergreening, particularly provisions which allow innovators to make objectively arbitrary modifica­ tions to drugs in order to maintain their monopoly. if it takes considerably longer to obtain fda approval of generic biologics than obtaining fda approval of chemical drugs, brand name companies will already be pro­ vided with effective exclusivity, even if this exclusivity is not provided by statute. 189 the obama administration will likely serve as a catalyst for enact­ ment of this legislation.190 even though pressure continues to mount to pass biogenetic legislation, it appears likely that the public will have to wait until the next administration is in office. the thirty percent savings that would be gained has significant implications for insurance companies and 184. kolata, supra note 42 (emphasis added). 185. kotlikoff, supra note 28, at 15. 186. id at 16. 187. id 188. grabowski and vernon, supra note 111, at 116. 189. ld. at 104. 190. see julie a. birkofer, barack obama 's presidential win l)enotes big change for the u.s., 2008 the source 16, 16-18, available at http://www.pptaglobal.org/userfilesl file/source%20magazine/obama_ wintet'.42008.pdf(last visited mar. 10, 2010). 396 indiana health law review [vol. 7:367 medicare.191 any issue affecting health insurance and medicare will play a role in the inevitable modification of our health care system. n. conclusion the brand name pharmaceutical companies' case against the introduc­ tion of biogenerics, or for lengthy exclusivity provisions, do not comport with the best interests of our nation's economy and public health. appro­ priate measures to protect innovators' investment will be an essential part of any follow-on biologics legislation, but excessive exclusivity will stifle in­ novation and harm consumers unable to afford costly biologics. the hatch­ waxman act's success in the regulation of generic chemical drugs indicates that similar legislation should be applied to biogenerics. the hatch­ w axman act should be used as a template to craft biogeneric legislation, which will provide much needed relief to those in need of these expensive, life-saving drugs. 191. id the case for state mandatory assignment of benefits legislation elliott mckinnis • i. introduction •..•••.••...........•••..••..•................•.••...........•••....••....••..• 172 ii. background: history of heal til care plans and aob ....•• 173 a. managed care and the alphabet soup ..................................... 173 b. the development of managed care plans ............................... 175 c. health insurance contracts ...................................................... 176 d. legal challenges to anti-assignment provisions ..................... 177 e. aob laws around the country ................................................. 178 1. overview of aob laws around the country ...................... 178 2. florida's recent aob law ................................................. 179 3. indiana's efforts to pass an aob law ............................... 180 iii. arguments in favor of states mandated aob ................... 181 a. mandatory aob would provide fairness to providers ........... 181 b. mandatory aob would eliminate many administrative problems associated with payments and billing ..................... 183 c. mandatory aob would reduce the amount of litigation between insurers and providers .............................................. 184 d. mandatory aob would reduce the amount of out-of-network providers who require full payment up front ................................................................................... 185 n. arguments against states mandating aob ....................... 186 a. mandatory aob would weaken insurers' health care networks .................................................................................... 186 b. mandatoryaob would increase health care costs ............... 187 c. mandatory aob would inteifere with an insurer's ability to manage quality ofcare ....................................................... 189 v. whytiieargumentsinfavorofmandatoryaob prey ail and how legislation should be structured ........ 190 a. why indiana should mandate aob .......................................... 190 1. how the refusal of insurers to honor aob harms the health care system ........................................................ 190 2. the evidence fails to show that mandatory aob weaken networks ................................................................. 191 3. the evidence fails to show that mandatory aob increases health care costs generally ............................... 192 b. structure of the legislation ....................................................... 193 1. indiana legislators should consider a conditional * j.d., 2010, indiana university school of law-indianapolis; b.a., 2002, ball state university. 172 indiana health law review [vol. 8:171 sunset provision .................................................................. 193 2. indiana legislators should consider imposing requirements on reimbursement amount ........................... 194 3. indiana legislators should consider prohibiting out-of-network providers from balance billing ................. 195 4. indiana legislators should consider repealing the state's awp law .................................................................. 197 vi. conclusion .................................................................................. 197 i. introduction after visiting a non-network urologist, a virginia woman's insurer sent her a check to cover a portion of the expenses incurred. around the same time she received the check, her son's college tuition also came due. the woman used the money from her health insurance check to pay the university. she still owed her urologist, however, and when the urologist tried to collect from her sometime later, he was unable to do so because she had declared bankruptcy. 1 this story is not unique. in fact, some doctors say it occurs often enough that it threatens their ability to provide health care services.2 a potential solution is to require insurance companies to honor an individual's wish to send payments directly to her provider, even if the provider is not in the insurer's network. in other words, an individual should have the power to assign her benefits to an out-of-network provider. some states have passed mandatory assignment of benefits ("aob") legislation.3 a mandatory aob law requires insurers to send payments di­ rectly to out-of-network providers who have executed an aob agreement with the covered individual. proponents of mandatory aob legislation suggest there are other important advantages to aob beyond making it eas1. tammie smith, va. doctors make their case they are lobbying legislators for changes in how benefits, reimbursements are handled, richmond times dispatch, jan. 24, 2005, at al. 2. see, e.g., id, smith supra note 1. 3. see ala. code § 27-1-19 {2010); alaska stat. § 21.51.120 {2010); cal. health & safety code§ 1371.4 {deering 2010); cow. rev. stat.§ 10-16-317.5 {2010); conn. gen. stat. 38a-472 (2010); fla. stat.§ 627.638 {2009); ga. code ann. § 33-24-54 (2010); idaho code ann. § 34-3417(3) (2010); 215 ill. comp. stat. ann. 5/370a (lex­ isnexis 2010); la. rev. stat. ann.§ 40:2010 (2010); me. rev. stat. ann. tit. 24, § 2332-h (2010); mo. rev. stat. § 376.427 (2010); nev. rev. stat. ann. § 689a.l35 (lexisnexis 2010); n.h. rev. stat. ann. § 420-b:8-n (lexisnexis 2010); n.c. gen. stat. § 58-3-225 (2010); omo rev. code ann.§ 3901.386 (lexisnexis 2008); r.i. gen. laws§ 27-18-63 (2010); s.d. codified laws§ 58-17-61 (2010); tenn. code ann.§ 56-7-120 (2010); tex. ins. code ann.§ 1204.053 (west 2009); va. code ann. § 38.2-3407.13 (2010); wyo. stat. ann.§ 26-15-136 (2010); see also or.. rev. stat.§ 743-531 (2009) (allowing but not requiring insurers to honor aob); wash. rev. code§ 48.44.026 (west 2010) (generally requiring the signature of the out-of-network provider in order to deposit a check from an insurer). 2011] state mandatory assignment of benefits legislation 173 ier for health care providers to collect payments.4 however, critics contend that mandatory aob would have negative effects on the health care sys­ tem. 5 section ii of this note presents background information on the history of the aob issue. section m examines the arguments in favor of mandato­ ry aob legislation, and section iv explores the arguments against manda­ tory aob. finally, section v explains why the arguments in favor of mandatory aob prevail and how indiana should structure mandatory aob legislation. ii. background: history of health care plans and aob a briefhistory of the development of the health care industry provides a helpful basis on which to analyze the aob issue. the most basic reason for the existence of health insurance plans is that people want to share the risk of financial loss due to illness or injury.6 a health insurance plan gen­ erally includes four parties: consumers, providers, sponsors, and intermedi­ aries.' consumers, often referred to as ''insureds," "patients" and "subscribers," are those who receive care from providers. 8 sponsors in­ clude employers who offer a group health benefit plan to their employees and pay a majority of the plan's expenses.9 in the case of medicare and medicaid, the government plays the role of sponsor.10 intermediaries pro­ vide an administrative framework, which includes the bill paying process (i.e., payers, insurers, health plans, etc.).11 a. managed care and the alphabet soup many health plans today fall under the label of ''managed care."12 definitions of managed care vary.13 however, a common definition de­ scribes it as a system that attempts to control health care cost, access, and 4. see, e.g., steven r. west, fla. med. ass'n president. op-ed., more choices, ac­ cess needed for patients, sun sentinel (fort lauderdale), june 4, 2009, at 12a. 5. see, e.g., catherine dolinski, gaetz says health bill is good for workers, tampa tribune, may 22, 2009, at 10. 6. peter r. kongstvedt, managed care: what it is and how it works 21 (3rd ed. 2009); jonathan p. weiner & gregory de lissovoy, razing a tower of babel: a taxon­ omy for managed care and health insurance plans, 1s j. health pol. pol'y & l. 75, s1 (1993). 7. weiner & de lissovoy, supra note 6, at so-st. s. id 9. id. at so. 10. id. at so-st. 11. id. at sl. 12. see generally kongstvedt, supra note 6, at 17-53 (describes the types of managed care plans in existence today); william n. tindall et al., a guide to managed care med. s-14 (2000) (describes the types of managed care plans in existence today). 13. kongstvedt, supra note 6, at230. 174 indiana health law review [vol. 8:171 quality. 14 defining the separate classes of managed care. health plans is also a difficult task. 15 some analysts describe the health care system as an ''un­ intelligible alphabet soup of three-letter health plans."16 examples of the three-letter health plans include health maintenance organizations ("hmos"), preferred provider organizations (''ppos"), and point-of-service plans ("poss"). 17 at one time, the individual models included unique features that dis­ tinguished them from each other. 18 hmos, in their purest form, involve prepaid arrangements where the payer offers subscribers health care ser­ vices in exchange for a monthly fee.19 hmo models attempt to control health utilization and quality more than other plans.2° hmos are designed to include a primary care physician .who operates as a gatekeeper by over­ seeing the patient's care and provirung referrals to specialists.21 except un­ der limited circumstances, a subscriber is responsible for the total health care costs when visiting a provider outside of the hm0.22 the ppo design involves less control of health care cost and quality than hmo plans, but generally gives the patient more freedom in choosing providers.23 ppos contain a network of physicians who bill for each service at a discounted rate.24 a subscriber may have a deductible, which is a fixed out-of-pocket amount the consumer is required to pay before the health plan will cover any fees.25 after the deductible is met, the subscriber then may pay a coinsurance amount, which is a small percentage of each service he receives.26 some providers, specialists in particular, are often outside of ppo networks.27 if the patient wants to use an out-of-network provider, the health plan will reimburse the subscriber, usually at a rate that is reduced by a difference of twenty percent.28 for example, if a health plan pays eighty 14. seeid. 15. id. at 17. 16. weiner & de lissovoy, supra note 6, at 75. 17. see generally kongstvedt, supra note 6, at 17-53; tindall et al., supra note 12, at 8-14; carol k. lucas & michelle a. williams, the rights of nonparticipating providers in a managed care world: navigating the minefields of balance billing and reasonable and customary payments, 3 j. health & life sci. l. 132, 135 (2009). 18. see kongstvedt,supra note 6, at 17-18. 19. id at226. 20. /dat32. 21. lucas & williams, supra note 17, at 135. 22. kongstvedt, supra note 6, at 32. 23. seeid. at30-31;seealsolucas&williams,supranote 17,at 135. 24. kongstvedt, supra note 6, at 30-31. 25. /d. 26. id at 30-31,213. 27. mandated health benefit task force, report of the mandated benefit task force 5 (2008), available at http://www.in.gov/legislativeligareports/agency/ re­ ports/100137 .pdf. 28. kongstvedt, supra note 6, at 31. 2011] state mandatory assignment of benefits legislation 175 percent of the cost of a certain service offered by an in-network provider, the plan would pay sixty percent for that same service when offered by an out-of-network provider. 29 a pos plan is a hybrid of plans similar to hmos and ppos?0 pos plans operate similar to hmos when the consumer follows hmo proce­ dures?1 when the subscriber wants to use an out-of-network provider, the pos operates more like a pp0.32 b. the development of managed care plans researchers assert that managed care originated in 1910, when a group of providers in washington began offering a broad range of services to tacoma lumber mill workers for a monthly premium of $0.50 per mem­ ber.33 this concept evolved during the great depression when physician groups and hospitals established health plans to maintain or increase patient revenue.l4 by world war ii, employers began creating hmos as a benefit for employees and other consumers demanding greater access to less expen­ sive health care. 35 in the 1960s, the cost ofhealth care skyrocketed.36 in an effort to sup­ port the development of more private sector health plans, congress passed the hmo assistance act of 1973.37 meanwhile, in the 1970s the health care system saw the creation of pp0s.38 despite this growth in managed care, by 1980 approximately ninety percent of employed americans re­ ceived health coverage from indemnity insurance.39 however, in the 1980s traditional indemnity plans began to decline, while the prevalence ofhmos and other managed care entities grew.40 by 1990, indemnity plans covered 29. see generally peter r. kongstvedt. compensation of primary care physicians in managed health care, in the managed heal1h care handbook 132 (peter r. kongstvedt ed., 4th ed. 2001) (describing out-of-network fees). 30. kongstvedt, supra note 6, at 31-32; see also lucas & williams, supra note 17, at 135. 31. kongstvedt, supra note 6, at 31-32. 32. !d. at 31. 33. id at 1; see also tindall et al., supra note 12, at 4-6 (describing the evolution of managed care). 34. kongstvedt, supra note 6, at 2. 35. !d. at2-3. 36. tindallet al.,supranote 12, at5. 37. health maintenance organization act of 1973, pub. l. no. 93-222, 87 stat. 914 (codified as amended at 42 u.s.c: §§ 300e300e-17 (2010)); see also kongstvedt, supra note 6, at 2; tindall et al., supra note 12, at 5. 38. kongstvedt, supra note 6, at 6. 39. weiner & de lissovoy, supra note 6, at 76. see generally kongstvedt, supra note 6, at 29 (noting that indemnity plans traditionally did not include networks and made little or no attempt to control health care costs). 40. kongstvedt, supra note 6, at 9 (stating that "[i]n the mid-1980s, hmos grew fastest, but by the early 1990s, ppos began to grow even faster"); see also weiner & de lissovoy, supra note 6, at 77 ("by the end of the 1980s traditional insurance plans and estab176 indiana health law review [vol. 8:171 less than half of all americans.41 another spike in health care costs over the past decade led to an in­ crease in the consumer's responsibility to pay for care.42 today, the distinc­ tions among the numerous types of health care plans have been blurred.43 plans identified as hmos, for example, are adopting some characteristics of ppos and vice versa.44 c. health insurance contracts regardless of the label used, the health insurance industry utilizes contracts as the basis for the rights and responsibilities that one party owes another.45 the features of the contract include agreements on the services a plan provides, the process consumers must use to access those services, and the manner of reimbursement.46 contracts that include networks generally require the payers to reimburse the in-network providers directly for the services that those providers render to their patients who are consumers un­ der the plan.47 however, an insurance company has no contractual obliga­ tion to directly reimburse out-of-network providers because those providers do not share a contractual relationship with the plan.48 even though con­ tracts specify duties, laws, and regulations, courts also govern the relation­ ships among the parties.49 a modem view of courts interpreting contracts is that parties generally can assign, or in other words transfer, their contractual rights to a third par­ ty.50 receiving health insurance benefits is a right a policyholder has from a contract with the insurer, assuming that the policyholder does not violate any of the terms.51 therefore, under this modem approach to contract law, a covered individual could transfer the right to health insurance benefits to a lished hmos were joined by a stunning array of new health care financing .and delivery entities."). 41. weiner & de lissovoy, supra note 6, at 77 (citing elizabeth w. hoy et al., change and growth in managed care, 10 healthaff. 18 (1991)). 42. kongstvedt, supra note 6, at 15. 43. jd. at 17-18; see also weiner & de lissovoy, supra note 6, at 75 ("there is little agreement about which characteristics distinguished one type of plan from another."). 44. kongstvedt, supra note 6, at 10-11. 45. lucas & williams, supra note 17, at 136; see also weiner & de lissovoy, supra note 6, at 81. 46. lucas & williams, supra note 17, at 136-37. 47. see kongstvedt, supra note 6, at29. 48. lawrence foust, a proposal for resolving differences in managed care contract negotiations between providers and payers, in health law handbook§ 3:3 (alice g. gosfield ed., 2006). 49. lucas & williams, supra note 17, at 13 7. 50. somerset orthopedic assocs., p.a. v. horizon blue cross and blue shield of n.j., 785 a.2d 457, 460(n.j. sup. ct. app. div. 2001) (citing rumbin v. utica mut. ins. co., 757 a.2d 526, 531 (conn. 2000)); see also restatement (second) of contracts§ 317 cmt. c (1981) (stating that "the historic common-law rule that a chose of action could not be as­ signed has largely disappeared."). 51. see lucas & williams, supra note 17, at 136-37. 2011] state mandatory assignment of benefits legislation 177 third party, such as an out-of-network provider. under this scheme, the in­ surer would send reimbursement directly to the out-of-network provider. d. legal challenges to anti-assignment provisions before the last decade, insurers in indiana generally allowed policy­ holders to assign benefits to out-of-network providers.52 currently, some health plans have contractual provisions with policyholders that prohibit the covered individual from assigning benefits to out-of-network providers.53 courts usually do not allow parties to assign their rights when the contract includes provisions that explicitly prohibit assignment.54 when consumers have challenged prohibitions on assignment, courts have generally upheld the provision by reasoning that assigning benefits is against public policy. 55 nonetheless, there is at least one outlier decision in which the court used public policy considerations to actually require an insurer to honor aob.56 52. interview with michael rinebold, dir. ofgov't relations, ind. state med. ass'n, in indianapolis, ind. (nov. 24, 2009) [hereinafter interview with rinebold]; see also, e.g., letter from stacey breidenstein, director, provider contracting & institutional relations, carefirst bluechoice, inc., to providers (aug. 8, 2005}, available at http://www.bmbassoc.com/issues/aob/docs/bcbs_2008o/n20carefirsto/o20reimbursement% 20for%20non-par%20svcs.pdf (explaining that the insurer would stop sending reimburse­ ments directly to out-of-network providers). 53. interview with rinebold, supra note 52; see, e.g., parrish v. rocky mountain hosp. & med. servs. co., 754 p.2d 1180, ll8l-82 (colo. ct. app. 1988) (quoting a blue cross blue shield ("bcbs") of colorado contract provision that read: "all benefits stated in the contract are personal to the employee or dependent. neither those benefits nor [bcbs] of colorado's payments to the covered individual may be assigned to any person, corpora­ tion or entity: any attempted assignment shall be void. the only exception to this provision is [bcbs] of colorado's right to pay participating facility and professional providers direct­ ly."); see also kongstvedt, supra note 6, at 2. 54. somerset orthopedic assocs., 785 a.2d at 460 (citing owen v. can insur­ ance/continental cas. co., 771 a.2d 1208, 1213-14 (n.j. 2001)); see restatement (second) of contracts § 317(2) ("a contractual right can be assigned unless ... assign­ ment is validly precluded by contract."). 55. see, e.g., st. francis reg'l med. ctr. v. blue cross blue shield ofkan. inc., 810 f. supp. 1209 (d. kan. 1992), aff'd, 49 f.3d 1460 (loth cir. 1995); parrish, 754 p.2d at 1182 ("[n]on-assignment clauses in this type of contract are valuable tools in persuading health providers to keep their health care costs down .... "); kent general hosp., inc. v. blue cross and blue shield of del., inc., 442 a.2d 1368 (del. 1982); augusta med. com­ plex, inc. v. blue cross of kan., inc., 634 p.2d 1123 (kan. 1981); obstetricians­ gynecologists, p.c. v. blue cross and blue shield ofneb., 361 n.w.2d 550 (neb. 1985); somerset orthopedic assocs., 785 a.2d at 464 ("[t]he anti-assignment clause is a critical tool to [the insurer's] efficient and effective functioning .... ");kassab v. med. serv. ass'n. ofpa., inc., 39 pa. d. & c.2d 723, 725 (1966) (holding that the anti-assignment clause was valid and essential to the continued success of the insurer's plan), aff'd per curiam, 230 a.2d 205 (pa. 1967); see infra part n (discussing why courts have found assignment of benefits to out-of-network providers against public policy). 56. am. med. int'l, inc. v. ark. blue cross and blue shield, 773 s.w.2d 831, 832 (ark. 1989) (noting that an insured has an "interest in freely assigning the right to payment . . . . ");see also st. francis reg'l med. ctr., v. blue cross and blue shield ofkan., 49 f.3d 1460, 1468-70 (loth cir. 1995) (ebel, j., dissenting) (explaining that the district court's de178 indiana health law review [vol. 8:171 e. aob laws around the country 1. overview of aob laws around the country because the position of the majority of courts is to enforce anti­ assignment provisions when they exist in health insurance contracts, some states have enacted laws to force insurers to accept a patient's request for aob.57 as of january, 2010, approximately two dozen states had enacted mandatory aob laws. 58 approximately half of those states have aob laws that cover many types of providers.59 the aob laws of the remaining states only apply to certain categories like dental or emergency care. 60 further, some people who participate in the aob debate believe that whether a state has an any-willing-provider ("a wp") law is relevant to the question of whether aob legislation is appropriate.61 a wp laws require insurers to accept into their networks any provider that meets the general standards set by the insurer.62 nearly half of the states in the nation have a wp laws, most of which are limited to dental and pharmacy services. 63 fewer than ten states apply their a wp laws to health care providers beyond dental services.64 indiana's a wp law, for example, establishes that "[n]o hospital, physician, pharmacist, or other provider . . . willing to meet the terms and conditions of [a network agreement] may be denied the right to enter into a [network].'.65 cision to dismiss the hospital's claim that bcbs of kansas's nonassignability clause violates public policy should be reversed). 57. foust, supra note 48. 58. see supra note 48; see also am. dental ass'n, assignment of benefits (201 0), available at http://www.ada.org/sections/advocacy/pdfs/thirdparty _assignment_ benefits. pdf; mandated healthbenefittaskforce,supranote 27, at 4. 59. mandated health benefit task force, supra note 27, at 2 (states with broad aob laws as of july 2008, are alabama, alaska, colorado, georgia, iuinois, maine, mis­ souri, nevada, tennessee and texas); see also am. med. ass'n, model assignment of benefits legis. (2004), available at http://www.bmbassoc.com/issues/aob/docs/ama_2004-aob%20model%20legislation.pdf. 60. mandated health benefit task force, supra note 27, at 3 (states with limited aob laws as of july 2008, are connecticut, idaho, louisiana, massachusetts, ohio, rhode island, south dakota, wyoming and virginia). see, e.g., ohio rev. code ann. § 3901.386 (lexisnexis 2008) (applying only to "hospital services provided on an emergency basis"); r.i. gen. laws§ 27-18-63 (2010) (applying only to dental care providers). 61. see infra part v.b.4. 62. mandated health benefit task force, supra note 27, at 3; see, e.g., ind. code ann. § 27-8-ll-3 (west 2003). see generally richard i. smith & kristin stewart, state regulation of managed care, in the managed health care handbook 1332, 1334-5 (peter r. kongstvedt ed., 4th ed. 2001) (describing state regulatory structures for managed . care organizations). 63. mandated health benem task force, supra note 27, at 4; see, e.g., ind. code ann.§ 27-8-ll-3 (west 2003). 64. mandated health benefit task force, supra note 27, at 4. 65. ind. code ann.§ 27-8-11-j(c) (west 2003); see also va. code ann.§ 38.2-3407 (2008) (''no hospital, physician or a type of provider [as defined by a separate statute] will­ ing to meet the terms and conditions offered to it or him shall be excluded (from a net2011] state mandatory assignment of benefits legislation 179 states have many different combinations of aob and a wp laws.66 some states have a broad aob law and a limited a wp law or vice versa.67 however, only georgia has both a broadly applied aob law and a broadly applied awp law.68 2. florida's recent aob law in 2009, florida joined the ranks of states with mandatory aob.69 despite strong opposition from blue cross blue shield ("bcbs") of flori­ da and from consumer groups, the florida legislature passed a mandatory aob bill.70 the bill, which took effect july 1, 2009, amended florida's statutes to require mandatory aob to all providers.71 florida's aob statute now reads as follows: work]."). whenever, in any health insurance claim form, an in­ sured specifically authorizes payment of benefits di­ rectly to any recognized hospital, licensed ambulance provider, physician, dentist, or other person who pro­ vided the services in accordance with the provisions of the policy, the insurer shall make such payment to the designated provider of such services. the insur­ ance contract may not prohibit, and claims forms must provide an option for, the payment of benefits directly to a licensed hospital, licensed ambulance provider, physician, dentist, or other person who pro­ vided the services in accordance with the provisions of the policy for care provided. the insurer may re­ quire written attestation of assignment of benefits. 66. mandated health benefit taskforce, supra note 27, at 4. 67. id. 68. id.; see, e.g., ga. code ann. § 33-24-54 (requiring insurers that pay benefits di­ rectly to network providers to also pay benefits directly to: "any similarly licensed nonpartic­ ipating or nonpreferred provider who has rendered such services, has a written assignment of benefits, and has caused written notice of such assignment to be given to the person licensed under this title or jointly to such nonparticipating or nonpreferred provider and to the in­ sured, subscriber, or other covered person; provided, however, that in either case the person licensed under this title shall be required to send such benefit payments directly to the pro­ vider who has the written assignment."); ga. code ann.§ 33-20-16 (2006) (requiring "[ e ]very doctor of medicine, every doctor of dental surgery, every podiatrist, and every health care provider within a class approved by the health care corporation who is appropri­ ately licensed to practice and who is reputable and in g<xj<l standing shall have the right to become a participating physician or approved health care provider for medical or surgical care, or both, as the case may be, under such terms or conditions as are imposed on other participating physicians or approved health care providers within such approved class under similar circumstances in accordance with this chapter. "). 69. see 2009 fla. laws. 2009-124 (codified at fla. stat.§ 627.638 (2009)). 70. dolinski, supra note 5. 71. fla. stat.§ 627.638(2) (2009). 180 indiana heal til law review payment to the provider from the insurer may not be more than the amount that the insurer would other­ wise have paid without the assignment. 72 3. indiana's efforts to pass an aob law [vol. 8:171 between 2005 and 2010, indiana legislators worked to enact broadly applied, mandatory aob legislation.73 as ofthe end of the 2010 session, the furthest point an aob bill reached in the legislative process in indiana was a vote in the chamber where it originated.74 in february, 2009, twenty­ five members of the indiana senate voted in favor of a mandatory aob bill, twenty-four members voted against it, and one member was excused from the vote.75 even though the bill received more votes in its favor, it failed because it lacked a constitutional majority.76 the bill would have required insurers to send benefit payments directly to all out-of-network providers when the provider and the consumer have an assignment of bene­ fits agreement. 77 legislators have continued their efforts beyond the 2009 session. 78 in the 2010 session, three senators introduced a bill similar to those introduced in previous years that would require broadly applied, mandatory aob. 79 however, this senate bill was never voted on during the short legislative session.80 in addition to working on aob legislation during sessions of the indi­ ana general assembly, state lawmakers and an independent state govern­ ment commission have analyzed the issue between sessions.81 in october 72. id 73. telephone interview with patricia miller, ind. state senator, ind. state senate, in indianapolis, ind. (dec. 10, 2009). 74. see s.b. 75, 116th gen. assemb., 1st reg. sess. (ind. 2009), available at http:/ /www.in.gov/apps!lsa/sessionlbillwatchlbillinfo?year-=2009&session= 1&request=getbi ll&docno=0075&doctype=sb. 75. roll call vote on s.b. 75, ind. gen. assem., http://www.in.gov/legislativelbills /2009/pdf/srollcal/0168.pdf.pdf(last visited sep. 7, 2010). 76. see ind. const. art. n, § 25 (requiring a majority of the senate's fifty members to pass a bill in the indiana senate). 77. s.b. 75, 116th gen. assemb., 1st reg. sess. (ind. 2009), available at http://www.in.gov/apps!lsa/sessionlbillwatchlbillinfo?year-=2009&session=l&request=getbi ll&docno=0075&doctype=sb. see generally ind. code§ 27-8-11-1 (2009) (defining pro­ vider as "an individual or entity duly licensed or legally authorized to provide health care services."). 78. see s.b. 326, 116th gen. assemb., 2d reg. sess. (ind. 2010), available at http://www.in.gov/apps!lsa/sessionlbillwatchlbillinfo?year-=2010&session=l&request=getbi ll&docno=326). 79. seeid. 80. seeid. 81. see generally mandated health benefit task force, supra note 27; ind. health; fin. comm'n,interim sludy committee meeting minutes of sep. 1, 3-4 (2009), availableathttp:l/www.in.gov/legislative!interimlcommitteelminutes/hfcoc91.pdf. 2011] state mandatory assignment of benefits legislation 181 2008, the mandated benefits task force82 issued findings and recommen­ dations regarding aob proposals.83 the report suggested that a mandatory aob law in indiana should only apply to situations where health care con­ sumers "have no choice in the selection of provider.',s4 as the report elabo­ rated, those situations could include providers who are emergency room physicians, anesthesiologists, radiologists, or pathologists.85 the task force further recommended that a mandatory aob law may need to include pro­ visions to protect consumers from receiving a bill for unreimbursed services after their providers receive payment directly from their insurers.86 ill. arguments in favor of states mandated aob as the indiana general assembly and other state legislatures debate the issue of whether to require insurers to honor aob agreements, many different interest groups have visited statehouses around the country. 87 the primary proponents of broadly applied, mandatory aob legislation include different groups ofproviders.88 for example, representatives from the indi­ ana state medical association ("isma") and from individual associations of chiropractors, psychologists, and dentists have appeared before state lawmakers in indiana to present their case as to why the state should have a mandatory aob law.89 a. mandatory aob would provide fairness to providers proponents of mandatory aob legislation argue it would provide fair­ ness to providers by ensuring that they would receive compensation for the services they offer.90 the indiana psychological association ("ipa'') says denying patients the right to assign benefits to their out-of-network provid­ ers "often prevents the psychologist's [sic] office from ever receiving pay­ ment."91 an association of maryland medical group administrators conducted a survey revealing that eighty-four percent of respondents indi­ cated that patients frequently fail to pay their medical bills after receiving 82. the governor appoints a ten-member task force with representatives from insur­ ance companies, consumers, health care providers, employers, and independent actuaries. ind. code ann. § 27-1-3-30 (west 2003). 83. see mandated health benefit taskforce, supra note 27. 84. ld. at 5. 85. !d. 86. ld. 87. see, e.g., dolinski, supra note 5; ind. health fin. comm'n, supra note 81, at 3-4. 88. see, e.g., ind. health fin. comm'n, supra note 81, at 3-4. 89. see, e.g., id at 4. 90. id. 91. ind. psychol. ass'n, aob posmon paper (2009) (on file with ind. legis. servs. agency and with author). 182 indiana healtii law review [vol. 8:171 reimbursements.92 the ip a explains that when patients receive reimbursement from their insurer, they often think that they no longer have a debt to their health care provider.93 meanwhile, the patients may use the reimbursements to cover other outstanding debts like a child's college tuition, resulting in an inabil­ ity to pay their medical provider.94 some medical group administrators and doctors note that collection problems involving patients who have received reimbursements are becoming an increasingly common occurrence.95 also, these situations are not limited to people who use their reim­ bursement checks for reasons as noble as paying a child's college tuition bill.96 in a newspaper opinion piece, the chief executive officer of a florida addiction-treatment program described the story of a man whose health in­ surance company sent him a reimbursement check.97 the man, who had received treatment for a drug addiction, did not pay his provider, but rather used the money to buy drugs off the street.98 the executive also described another man who received reimbursement of more than $1,000 and used it to take a trip, where he committed suicide.99 regardless of the reasons why patients fail to pay their providers after receiving a reimbursement check, the result is that at least some providers accumulate a significant amount of charges that must be written off as a loss and re-classified as an expense because it is unable to be collected (i.e., bad debt).100 the indiana dental association ("ida") compiled anecdotal data to show how collection issues are affecting providers.101 a survey of dentist offices in central and northern indiana showed that each accumulat92. letter from kern tolliver, gov't affairs chair, md. med. grp. mgmt. ass'n, to thomas middleton, state senator, comm. chairman, md. s. fin. comm. (mar. 17, 2009) [hereinafter letter from tolliver], available at http://www.bmbassoc.com/ is­ sues/aob/docs!md_2009%20mgma%20letter%20to%20middleton.pdf. 93. ind. psychol. ass 'n, supra note 91. 94. smith, supra note 1. 95. hearing on s.b. 852 before the senate finance committee, 2010 leg., 426th sess. (md. 1999) (written testimony of the hosp. based physician coal. in support of s.b. 852), available at http://www.bmbassoc.com/issues/aob/docs/ md_ 2009%20sb%20852%20aob%20testimony.pdf; letter from tolliver, supra note 92 ("with the current state of our economy, it is highly improbable that the patient would turn over the payment to pay the provider for their services."). 96. see ind. health fin. comm'n, supra note 81, at 3 (representative of the indiana dental association stating states generally that people do not always have noble reasons for their alternative uses of their reimbursement checks). 97. chris crosby, the watershed addiction treatment programs president, op-ed., paying mental health facilities directly saves lives, palm beach post, june 2, 2009, at 8a. 98. !d. 99. !d. 100. see ind. dental ass'n, 2008/2009 aob experience (on file with ind. legis. servs. agency and with author). 101. see id. 2011] state mandatory assignment of benefits legislation 183 ed $8,000 to $13,000 of bad debt in six months,102 or roughly ten percent of the revenues an average dentist office would receive after overhead expens­ es are subtracted. 103 one dentist stated that his billing staff spends forty percent of its time trying to locate money from patients who have received reimbursement from their insurers but have yet to pay their debt with their dentist. 104 providers who experience collection problems may incur bad debt and subsequently raise rates. 105 proponents further argue that insurers may deny aob as a way to force providers into a network that has low reimbursement rates. 106 some providers say allowing health insurance companies to reject aob presents them with the undesirable choice of either entering a network and accepting lower reimbursement rates or staying outside the network and chasing pay­ ments that the insurer sends to their patients.107 therefore, some providers suggest that using the direct payment incentive as leverage is an unfair business practice.108 some doctors say this is especially unfair in the cur­ rent health insurance system because providers have a decreasing amount of bargaining power in negotiations with health plans.109 while insurance companies acknowledge that direct payments are used to attract providers to their networks, they argue that the direct payment incentive is justified be­ cause it helps them build or maintain strong networks, which leads to a re­ duction ofhealth care costs. 110 b. mandatory aob would eliminate many administrative problems associated with payments and billing aob proponents also assert that the process of insurers reimbursing patients for out-of-network medical services is cumbersome without 102. ld. 103. interview with ed popcheff, director of gov't relations, ind. dental ass'n, in indianapolis, ind. (dec. 10, 2009). 104. ind. dentalass'n, supra note 100. 105. see ind. health fin. comm'n, supra note 81, at 3; see also smith, supra note 1 (quoting an internist who said that "[y]ou can't run a practice with thousands of dollars not corning in."). 106. ind. health fin. comm'n, supra note 81, at 3; see also lucas & williams, supra note 17, at 143; ind. psychol. ass'n, supra note 91 ("some insurers pressure psychologists [sic] into signing their ppo contract by refusing to honor assignment of benefits for non­ ppo patients."). 107. ind. health fin. comm'n, supra note 81, at 3. 108. see, e.g., id. (stating that rejecting aob to force dentist to join networks is "simply wrong"). 109. smith, supra note 1 (describing the struggles some providers have during negotia­ tions with health plans); am. med. ass'n, aob legislation talking points (2004), avail­ able at http://www.bmbassoc.com/issues/aob/docs/ama_2004aob%20talking%20 pionts.pdf (describing that the "playing field" is becoming more unbalanced in favor of the insurers over the providers). 110. see infra part. iv.a-b. 184 indiana health law review [vol. 8:171 aob. 1 11 the ipa says that barring an individual from assigning benefits to a provider "disrupts payments to the psychologist's [sic] office [and] cre­ ates confusion .... "112 the ipa explains that the provider's office may not be informed that the patient received compensation, which could cause weeks of delay in the billing process. 113 this confusion, caused by the ina­ bility to assign benefits, may be compounded when the patient has coverage by more than one insurer.114 finally, the ipa asserts that in some cases in­ volving dual coverage, these administrative complications result in a patient failing to receive all of the benefits to which he or she is entitled.115 there is also concern that the effects of administrative billing difficul­ ties may discourage patients from visiting out-of-network providers, and thereby decrease patient access.116 the ida contends that aob would eliminate many of the administrative problems associated with payments and billing.117 even if a provider eventually receives payment, some note that the provider might experience delays and cash flow disruptions if it cannot receive payments directly from the insurer.118 some say that these delays harm patients because they reduce the time that providers can spend focusing on actual health care. 119 c. mandatory aob would reduce the amount of litigation between insurers and providers it is also argued that mandatory aob laws would provide efficiency, consistency, and predictability.120 many times when there are issues re111. ind. health fin. comm'n, supra note 81, at 3; see also mark r. stetzel & bob ketcham, dentists split about states benefit bill: pro, journal j. gazetie (fort wayne, ind.), jan. 30, 2009, at l3a ("for patients not expecting an insurance check, it's confusing when it arrives in the mail .... for those who do forward the check to their dentist, it's just another hassle they don't need."); am. med. ass'n, supra note 109. 112. ind. psychol. ass'n, supra note 91. 113. id. 114. id. ("if the patient is covered by more than one insurance company or by medicaid (dual coverage) the psychologist [sic] cannot file for secondary benefits on behalf of the patient until an explanation of benefits (eob) is received from the first carrier."). 115. id. 116. diane d. anderson, healthcare consultants, llc, aob legis. for healthcare providers 7 (2005), available at http://www.bmbassoc.com/issues/aob /docs/finalreport.doc (prepared for virginians for fairness in healthcare). 117. ind. health fin. comm'n, supra note 81, at 3 (a representative of the indiana dental association states that "the current process is a hassle to the patient and intrusive on administering a dental practice."); see also md. gen. assem. dep't of legis. servs., h.b. 594 fiscal and pol'y note 1 (2010), available at http://mlis.state.md.us/2010rs/fnotes/ bil_ 0004/hb0594.pdf 118. karin bierstein, rejecting a bad payer contract, am. soc'y of anesthesiologists newsletter, june 2005, available at http://www.asahq.org/ news1et­ ters/2005/06 _ 05/pracmgmt06 _ 05.html. 119. see, e.g., steven west, supra note 4. 120. foust, supra note 48. 2011] state mandatory assignment of benefits legislation 185 garding payments between insurers and out-of-network providers, the end result is litigation. 121 this creates significant transactional costs. 122 the isma fears that those transactional costs may negatively affect the cost of health care in general. 123 the isma states that health care providers do not want to play the role of creditor, but they are often forced to do so. 124 pro­ ponents think that allowing aob would help remove the need for providers to go to court after patients fail to pay, because when the patient assigns the benefits, the insurer's reimbursement goes directly to the provider. 125 furthermore, when an insured is unable to assign benefits to an out-of­ network provider, the provider generally cannot challenge the insurer's re­ imbursement126 the american medical association says that providers are more willing and capable of investigating and appealing the reimburse­ ments when a dispute exists concerning the amount the health plan should cover.127 therefore, the organization says that it is unfair to give patients the responsibility of legally challenging a reimbursement. 128 d. mandatory aob would reduce the amount of out-of-network provid­ ers who require full payment up front proponents argue that aob would reduce the number of out-of­ network providers who require full payment before services are rendered because they know they will receive some reimbursement from an insur­ er.129 for example, many indiana psychologists have begun to ask for up­ front payments because of the difficulty of collecting payments after they provide services.130 many dentists who do not participate in a network are also forced to choose whether to require up-front payments or risk that the 121. id 122. id 123. interview with rinebold, supra note 52. 124. id 125. /d. 126. david m. hyman et al., hey, what about me? non-participating healthcare pro­ viders' ability to sue health insurance companies regarding payment of claims, n.j. lawyer, february 2007, at 37 ("without a valid assignment, non-participating providers face a considerable hurdle in establishing the right to demand or contest payment from health insurance companies."). 127. am. med. ass'n, supra note 109. 128. id 129. see dolinski, supra note 5; am. men. ass'n, supra note 109 ("if an assignment is given by the patient and ignored by the insurer, the patient is forced to 'front' the cost of the service, until the insurer either sends payment to the patient or the provider reimburses the patient. this is an unreasonable burden to place on the consumer."). 130. ind. health fin. comm'n, supra note 81, at 3; see also ind. psychol. ass'n, supra note 91 (''[aob] often allows patients to leave the office without making full payment for services, knowing that the psychologists will bill them for any balance not paid by the insurance company."). 186 indiana health law review [vol. 8:171 patient will not pay later.131 because of this, the ida argues that aob would lead to "little or no up-front costs at the time oftreatment."132 iv. arguments against states mandating aob a. mandatory aob would weaken insurers' health care networks as proponents of mandatory aob present their arguments to state lawmakers, health insurance companies, employers, and labor unions join forces to argue their opposing positions. 133 a chief argument against enact­ ing broadly applied, mandatory aob is that it would weaken insurers' health care networks.134 insurance companies contend that a doctor's abil­ ity to receive reimbursements directly from an insurer is an important in­ centive for the physician to join the insurer's network. 135 the argument is that if any provider can receive direct payments from any insurer, then there is less of an incentive to stay in a certain network. 136 during aob legislative debates in maryland, an insurer presented ev­ idence regarding the effect aob had on other health plans.137 the mary­ land-based insurer, carefirst bcbs, reported that when idaho enacted mandatory aob in 1992, half of the dentists in one network dropped out of it within a matter of weeks.138 carefirst also noted that a survey of hawai­ ian providers indicated that slightly more than half would leave a network if insurers were required to honor aob. 139 carefirst also presented data that 131. ind. health fin. comm'n, supra note 81, at 3. 132. support patient rights support assignment of benefits, ind. dental ass'n, http://www.supportpatientrights.com (last visited dec. 7, 2010). 133. see, e.g., ind. health fin. comm'n, supra note 81, at 3-4; dolinski, supra note 5; smith, supra note 1. 134. see lucas & williams, supra note 17, at 143-44; va. dep't of planning and budget, h.b. 253 fiscal impact statement 1 (2006), available at http://leg l.state.va.us/cgi-bin!legp504.exe?071 +oth+hb253f 122+pdf; john m. wander & daniel freier, renden & anders, ltd., the potential impact of state mandatory assignment legis. on consumers 10 (2003), available at http://www .bcbsok.comlgrassroots/pdfi'bcbsa_ assignmentofbenefitsrpt_ oct03.pdf (prepared for bcbs ass'n); smith, supra note 1; ind. health fin. comm'n, supra note 81, at 3-4. 135. fla. s., s.b. 1122 analysis and fiscal impact statement 4 (2009), available at http://www.flsenate.gov/data/session/2009/senatelbillslanalysislpd£'2009s1122.ga.pdf; see also dolinski, supra note 5; mandated health benefit task force, supra note 27, at 4 ("direct payment of claims to participating providers is a key benefit of contracting with a health care payer."); letter from william casey, v.p. gov't affairs, carefirst bcbs, to thomas middleton, state senator, md. s. fin. comrn. 1 (mar. 4, 2009) [hereinafter letter from casey], available at http://www.bmbassoc.com/issues /aob/docs/bcbs_2009%20letter'lo20too/o20middleton%20sb%20852.pdf. 136. smith, supra note 1. 137. letter from casey, supra note 135, at 3. 138. id. 139. id. (the source does not state whether this survey was scientific). 2011] state mandatory assignment of benefits legislation 187 a virginia insurer bad a stronger network after adopting a policy to refuse aob. 140 it was further mentioned by carefirst that insurers in nevada and colorado have experienced difficulty in establishing strong networks be­ cause of mandatory aob legislation.141 advocates for the health industry argue that a weakened network would result in less access to care for pa­ tients because there would be fewer providers participating in a network.142 b. mandatory aob would increase health care costs in addition to decreased. access to health care services, many argue that weakened networks would generally result in higher health care costs.143 during the aob debate in the virginia general assembly in 2006, a representative of a health insurance company explained to a journalist that "[h ]ealth plan networks are all that stand between consumers and full charges."144 health insurance industry representatives say that networks exist so insurers can negotiate rates with providers in an effort to contain or reduce the amount of money consumers pay out of their pockets for health care services.145 a provider would agree to this lower rate in exchange for a higher volume of patients.146 health insurance representatives say that the agreement of in-network doctors to provide services at a discounted rate "substantially reduces health-care premiums."147 the bcbs association commissioned a study in 2003 that showed discounts and protections that patients receive from using networks for their care amount to thousands of dollars for people with major medical condi­ tions.148 the study looked at five patient ''profiles,"149 and found estimated annual cost savings of $3,234 to $13,482 for in-network physician services and $6,751 to $30,404 for in-network hospital services.150 the study con140. id. 141. id. nevada first enacted an aob law in 1983, and colorado did the same in 2005. mandatedhealtiibenefittaskforce,supranote27, at2. 142. bob lotane, commc'ns and pol. affairs dir., nat'l ass'n of ins. fin. advisors, op-ed., direct assignment bill guts preferred provider plans, palm beach post, june 4, 2009,at 12a 143. see jed jacobson, v.p. of delta dental of ind., guest commentary, assignment of benefits hits patients in pocketbooks, the times of northwest ind., jan. 29, 2009; cyrus jollivette, senior v .p. of public affairs, bcbs of fla., op-ed., sb 1122 will undermine ppo networks, raise health-care costs, palm beach post, june 11, 2009, at loa; ind. healtiifin. comm'n, supra note 81, at 3. 144. smith, supra note l 145. wander& freier, supra note 134. 146. smith, supra note l. 147. lotane, supra note 142. 148. seewander&freier,supranote 134. 149. see id. at 7-8 (noting the five profiles as, "woman with advanced breast cancer," "man with coronary artery heart disease," "child with severe asthma," ''woman with ischem­ ic stroke," "man with diabetes mellitusj. 150. /d. at 10. 188 indiana health law review [vol. 8:171 eluded that savings like these might be reduced if networks were weakened as a result of mandatory aob. 151 some argue that even if doctors do not leave their networks, aob to out-of-network providers may give network doctors more leverage in their negotiations with insurers to argue for higher reimbursements.152 this leverage could interfere with the insurer's ability to negotiate with network providers for a lower reimbursement rate and thus could translate to higher medical costs for consumers. 153 according to the insurer, carefirst, aob legislation in idaho in 1992 resulted in a twenty-nine percent increase in out-of-pocket health care costs. 154 carefirst estimates that for every ten-percent loss in provider par­ ticipation in its network, the health care costs for consumers would increase by eight percent.155 the health insurance industry further argues that the deterioration of their ppo networks would increase the number of unin­ sured citizens. 156 some employers and labor unions fear that weakened networks would translate to higher premiums. 157 employers are worried that by weakening health care networks, mandatory aob would interfere with an insurer and an employer negotiating a contract.158 legislative staff in virginia who an­ alyzed the issue came to the conclusion that weakened health care networks would lead to higher premiums for both employers and their employees.159 when florida considered passing a mandatory aob bill in 2009, bcbs of florida asserted that a mandatory aob would impose a signifi­ cant cost to florida's state employees' health insurance trust fund be­ cause of the effect of a weakened network.160 a bcbs of florida analysis showed that it would cost the trust fund between $9.9 million and $25.7 million in one fiscal year.161 florida's department of management services contracted out a study to review bcbs of florida's analysis of how much mandatory aob would cost the state. that study showed a range of $5.1 151. id 152. dolinski, supra note 5. 153. see fla. s., supra note 139. 154. letter from casey, supra note 135, at 3. 155. id. at 2. 156. jollivette, supra note 143. 157. see, e.g., ind. healm fin. comm'n, interim snmy commiti'ee meeting minutes of sep. 1, exhibit 7, 3 (2009) ("[mandatory aob legislation would] have a very significant impact on increasing the cost of health care and forcing even more employers to discontinue providing coverage.") (on file with ind. legis. servs. agency and with author); ind. health fin. comm'n, supra note 81, at 4 (afl-cio representative stating that strong networks result in millions of dollars worth of savings and "direct payments to out-of­ network providers would increase costs"). 158. ind. health fin. comm'n, supra note 81, at 4. 159. va. dep't of planning and budget, supra note 134. 160. fla. s., supra note 135; see also va. dep'r of planning and budget, supra note 134. 161. fla.s.,supranote 135. 2011) state mandatory assignment of benefits legislation 189 million to $18.5 m.illion.162 the state's independent study also showed that mandatory aob would increase an individual's out-of-pocket expenses by seventy-five percent.163 c. mandatory aob would interfere with an insurer's ability to manage quality of care in addition to managing the cost of health care, insurers attempt to control the quality of care.164 some believe that conferring the right to col­ lect directly from insurers would blur the distinction between network pro­ viders and out-of-network providers, which could be harmful to the system. 165 for good or bad, networks play a central role in the benefit de­ sign of our health care system. 166 the ability to collect reimbursements di­ rectly from insurers is often only available to providers who are in the health plan's network.167 however, the method of receiving reimburse­ ments for services is not the only distinction between network providers and out-of-network providers. among the many important differences are qual­ ity assurance and credentialing. 168 therefore, some argue that blurring the distinction between network providers and out-of-network providers would harm the insurance companies' ability to create what they think is the most "intelligent, legally acceptable, and commercially attractive" benefit de­ sign.169 furthermore, insurers argue that mandatory aob would result in providers exiting their networks.170 if this occurs, the health insurance companies would not be able to manage the quality of health care as effec­ tively because the network would have fewer participating providers.171 also, insurers may not be able to offer some specialized services like chron­ ic care management because of a lack of participating providers. 172 162. !d. (citing gabriel roeder smith & co., review of mandatory assignment model (2009)). 163. id 164. see kongstvedt, supra note 6, at 230. 165. foust, supra note 48. 166. !d. 167. see kongstvedt,supranote 6, at 139. 168. foust, supra note 48. 169. id; see also, e.g., letter ftom casey, supra note 135, at 3 ("carefit'st, like other carriers, continually strives to improve the quality of our networks."). 170. letter ftom casey, supra note 135, at 3. 171. !d. 172. !d. 190 indiana health law review [vol. 8:171 v. why tile arguments in favor of mandatory aob prevail and how legislation should be structured a. why indiana should mandate aob the parties who participate in the aob debate have in large part tried to present their arguments within the frame ofwhat is best for consumers. 173 however, both insurance companies and doctors have interests in making profits. one possible solution falls somewhere between the positions of providers, insurers, and sponsors. indiana legislators should require that health plans honor aob, as well as create a conditional sunset provision for the aob legislation. the legislature should also consider imposing re­ quirements on the amount of reimbursement paid to out-of-network provid­ ers, prohibiting balance billing for emergency care services, and repealing the state's a wp law. 1. how the refusal of insurers to honor aob harms the health care system considering that anecdotal data dominates the aob debate, legislators likely have a difficult time weighing the potential outcomes of their deci­ sion regarding the aob issue.174 at least in indiana, opponents of manda­ tory aob note that proponents do not use empirical data to support their arguments. 175 for example, the testimonies of indiana providers detail the experience of only some medical offices.176 nonetheless, these testimonies show that the inability of at least some out-of-network doctors to receive direct reimbursements poses significant financial burdens on their practic­ es. 177 assuming that these providers will shift at least some of the financial burden to patients, it follows that the insurers' refusal to honor aob raises the cost of care that these out-of-network doctors provide.178 the evidence also shows that some consumers covered by a network plan choose to receive services from out-of-network providers at least some of the time. 179 when the insureds are unable to assign their health insurance benefits to their out-of-network providers, they often experience a cumber­ some process of waiting to receive payments from the health plan and pay­ ing their doctor's bills.180 the evidence further shows that the insurer's 173. see, e.g., id. at 4. 174. see ind. health fin. comm'n, supra note 81, at 3-4. 175. see id. at 3. 176. see id. at 3-4. 177. see id. 178. see generally supra part iii.a. 179. ind. health fin. comm'n, supra note 81, at 3-4. 180. see generally supra part iii.b. 2011] state mandatory assignment of benefits legislation 191 refusal to honor assignment requests increases the transactional costs of health care delivery, as doctors spend more time trying to collect payment from patients and patients have more disputes with their health plans re­ garding reimbursements.181 furthermore, the refusal to honor aob requires some providers to demand up-front payments from consumers because of the uncertainties of being able to collect from them.182 these additional consequences that result from an insurer's refusal to honor aob further raise or at least threaten to raise the cost of receiving services from out-of­ network providers. these consequences also likely affect, to some degree, access to care from out-of-network providers. 183 2. the evidence fails to show that mandatory aob weaken networks while the evidence shows that allowing insurers to prohibit aob in­ creases the cost of health care that some out-of-network doctors provide, the health insurance industry argues that a mandatory aob law would create a net increase in health care costs.184 however, information presented by health insurance companies does not prove such a position.185 in aob dis­ cussions, insurers primarily argue that aob laws threaten the strength of their networks. 186 for example, when the maryland general assembly considered an aob bill in 2009, an insurer, carefirst, presented data in an effort to show the effect of aob laws on the strength of health plan networks.187 as dis­ cussed more fully in section n, carefirst's information included anecdotal data about idaho dentists from 1992, a survey of hawaii providers, the ef­ fect of a virginia insurer's anti-assignment policy on its own network, and general statements about the strength of the networks of insurers from ne­ vada and colorado. 188 while this evidence supports the argument that aob laws may weaken health plan networks, it provides an insufficient basis to conclude that this result would happen in indiana if the legislature enacted mandatory aob. 181. see generally supra part ffi.c. 182. see generally supra part ffi.d. 183. see anderson, supra note 116, at 7. 184. see, e.g., ind. health fin. comm'n, supra note 81, at 3-4. . 185. see mgt of am., inc., research concerning premium rate changes for the fla. meo. ass'n 7 (2008) (on file with author) (finding that "[t]he direct impact of incorpo­ rating mandatory assignment of benefits and/or a reduction of the repayment period on health insurance premiums cannot be determined"). 186. see, e.g., ind. health fin. comm'n, supra note 81, at 3-4; see generally supra part iv .a. 187. letter from casey, supra note 135, at 3-4. but cf. letter from tolliver, supra note 92 (stating that a survey of maryland providers shows that ninety-percent would remain in­ network even iflegislature would enact aob law). 188. letter from casey, supra note 135, at 3-4; see also supra part iv.a. 192 indiana health law review [vol. 8:171 in 2005, a consulting group that studied the aob issue for a virginia group of doctors concluded that aob laws had not interfered with insurers' ability to provide "adequate cost-effective networks."189 the consultants observed that three of the four main health insurance companies in the united statesunited healthcare, aetna, and cignahonor aob but have not incurred any negative financial consequences for doing so.190 accord­ ing to some reports, the insurance company, humana, also honors aob while containing costs with a "strong" network.191 the evidence that sever­ al insurers voluntarily allow aob and maintain strong networks indicates aob laws would likely have minimal effect on the strength of health plan networks. other incentives, such as higher patient volume, will likely keep a large number of doctors in network, even if they can receive direct pay­ ments out ofnetwork.192 even if the networks of insurers would weaken in the coming years, the decline of strong networks would not necessarily be a result of manda­ tory aob. "an increasing number of physicians do not contract with man­ aged care companies."193 some providers believe a major reason for doctors leaving networks is because insurers' reimbursement rates are too low regardless of whether there is aob.194 3. the evidence fails to show that mandatory aob increases health care costs generally even assuming that aob laws weaken networks, health insurance companies have failed to prove the resulting weak networks would cause a net harm by increasing costs or limiting access to health care. as discussed previously, health insurance representatives commonly testify to the amount of health care savings members receive for participating in a. plan that uses a network. 195 for example, representatives often cite a 2003 study that a consulting group completed for the bcbs association.196 this study tracked the savings that some types of patients realized when they used in­ network doctors.197 in at least one aob debate, an insurer asserted that out­ of-pocket costs of consumers covered by a network increased by an esti189. anderson, supra note 116, at 28. 190. ld 191. dolinski, supra note 5; west, supra note 4. 192. dolinski, supra note 5. 193. hyman et al., supra note 126. 194. e.g., smith, supra note l. but cf., e.g., letter from casey, supra note 135, at 3 (explaining that the insurers' rates are "fair and reasonable''). 195. see, e.g., ind. healtii fin. comm'n, supra note 81, at 3-4; see also supra part n.b. 196. see wander & freier, supra note 134. 197. id 2011] state mandatory assignment of benefits legislation 193 mated twenty-nine percent in idaho in 1992 because of aob legislation.198 despite empirical evidence showing savings consumers realize for us­ ing network doctors, and anecdotal data like the experience of idaho pa­ tients, no one has established a correlation between aob and an overall increase of health care costs. 199 even assuming that mandatory aob laws increase health care costs for some consumers, health insurance companies have failed to show this would cause a net increase in total costs. further­ more, the evidence does not show that the increase in costs insurers fear would outweigh the financial burdens that out-of-network providers incur because of their inability to receive direct reimbursements. the extent of the harm that out-of-network providers in indiana expe­ rience because insurers refuse to honor aob is unknown. nonetheless, evidence shows that allowing payers to reimburse consumers directly in­ creases the cost of out-of-network services, assuming that out-of-network doctors share some of their financial burdens with their patients. mean­ while, aob opponents base their arguments on speculation, which does not show that mandatory aob would create a net harrn to health care costs. therefore, indiana should enact a broadly based, mandatory aob law. b. structure of the legislation 1. indiana legislators should consider a conditional sunset provision when florida implemented a broadly applied, mandatory aob, it in­ cluded a conditional sunset provision.z00 the amendment to florida's aob law are automatically repealed three years after its effective date if the of­ fice of program policy analysis and government accountability finds that "the amendments made by this act have caused the third-party administrator of the state group health plan to suffer a net loss of physicians from its pre­ ferred provider plan network and, as a direct result, caused an increase in costs to the state group health plan.''201 indiana has entertained a similar 198. letter from casey, supra note 135, at 2 (stating that "member out of pocket costs increased by an estimated 29% as a direct result of the passage of assignment of benefits legislation"). 199. see anderson, supra note ll6, at 28. 200. 2009 fla. laws. 2009-124 (codified at fla. stat. § 627.638 (2009)); see also about oppaga, office of program policy analysis and gov't accountability, http://www.oppaga.state.fl.us/shell.aspx?pagepath=about/about.htm (last visited dec. 7, 201 0) (the florida opp aga is a staff unit of the legislature responsible for examining agencies and programs "to improve services and cut costs when directed by state law, the presiding officers, or the joint legislative auditing committee." opp aga: supports the florida legislature by providing data, evaluative research, and objective analyses that assist legislative budget and policy deliberations.) 201. 2009 fla. laws. 2009-124 (codified at fla. stat.§ 627.638 (2009)) 194 indiana health law review [vol. 8:171 mechanism in its debate over imposing a mandatory aob.202 a conditional sunset provision could be a good tool to help protect the health care system in indiana if the insurance companies' worst fears were to occur because of aob legislation. 2. indiana legislators should consider imposing requirements on reimbursement amount requiring insmers to send payments directly to out-of-network pro­ viders could result in ''wasteful disputes" over the amount of reimburse­ ments.203 however, state legislators could create a more predictable business environment by imposing requirements on the reimbursement amount for out-of-network payments.204 only a limited number of states have enacted legislation that governs the amount insmers pay to out-of­ network providers.205 florida's mandatory aob law, for example, prohibits insurers from paying providers more than what the insurer would pay the·insured if there were no assignment. 206 if an insurer in oklahoma pays a provider less than what the provider billed, the payer must furnish, upon request, the rationale for the reimbursement amount. 207 in utah, payers must reimburse out-of­ network doctors at an amount that is at least seventy-five percent of the par­ ticipating provider rate.208 colorado insmers must reimburse out-of­ network providers the lesser of the following amounts: the provider's billed charges; a "negotiated rate"; and the "the greater of the carrier's average in­ network rate for the relevant geographic area or the usual, customary, and reasonable rate for such geographic area.'.z09 meanwhile, california's regu­ lations require insurers to pay out-of-network providers the "reasonable and customary value for the health care services," which is calculated based on the following: (1) the provider's training, qualifications, and length of time in practice; (ii) the natme of the services pro­ vided; (iii) the fees usually charged by the provider; 202. ind. health fin. comm'n, supra note 81, at 4. 203. foust, supra note 48. 204. id 205. id. see generally kongstvedt, supra note 29, at 132 (describing the method insur­ ers generally use to reimburse out-of-network providers). 206. fla. stat. § 627.638(2) (2009) ("payment to the provider from the insurer may not be more than the amount that the insurer would otherwise have paid without the assign­ ment"). 207. okla. stat. ann. tit. 36 § 6571 (west 2009). 208. utah code ann.§ 31a-22-617(2)(b) (2009). 209. colo. rev. stat. § 10-16-704(2xc) (2007). the statute defines the "usual, cus­ tomary, and reasonable rate" as "a rate established pursuant to an appropriate methodology that is based on generally accepted industry standards and practices." § 10-16-704(2xf)(iii). 2011] state manda wry assignment of benefits legislation (iv) prevailing provider rates charged in the general geographic area in which the services were rendered; (v) other aspects of the economics of the medical pro­ vider's practice that are relevant; and (vi) any unusual circumstances in the case.z10 195 although there is no consensus among the states on how to govern out-of­ network reimbursements, these examples provide guidance on how the in­ diana general assembly should control the reimbursement amount if or when it enacts a mandatory aob law. 3. indiana legislators should consider prohibiting out-of-network providers from balance billing indiana legislators may also want to consider implementing a prohibi­ tion on balance billing in some situations as a compliment to aob legisla­ tion. balance billing occurs when a provider bills a patient for the cost that exceeds the amount that the insurer covers.211 most states do not explicitly prohibit balance billing and insurers rarely can prohibit out-of-network pro­ viders from engaging in the billing practice.212 however, some states re­ strict out-of-network providers from balance billing.213 for example, new york rroviders cannot balance bill patients for emergency ambulance ser­ vices. 14 meanwhile, maryland and florida prohibit providers from balance billing any hmo member.215 the indiana mandated benefits task force in its analysis of the aob issue in 2008 recommended the state legislature to consider providing pro210. cal. code regs. tit. 28, § 1300.71(a)(3)(b) (2008). 211. kongstvedt, supra note 6, at 210. 212. lucas & williams, supra note 17, at 147. see generally foust, supra note 48 (providing a background on balance billing). 213. lucas & williams, supra note 17, at 148. 214. n.y. ins. law § 322l(l)(l5)(b) (mckinney 2010) (an ambulance service reim­ bursed pursuant to this section shall not charge or seek any reimbursement from, or have any recourse against an insured for the services provided pursuant to this paragraph, except for the collection of copayments, coinsurance or deductibles for which the insured is responsible for under the terms of the policy.). 215. fla. stat. § 641.3154(4) (2004xa provider or any representative of a provider, regardless of whether the provider is under contract with the health maintenance organiza­ tion, may not collect or attempt to collect money from, maintain any action at law against, or report to a credit agency a subscriber of an organization for payment of services for which the organization is liable, if the provider in good faith knows or should know that the organi­ zation is liable.); md. code ann., health-gen. § 19-710(p) (lexisnexis 2008)(a health care provider or any representative of a health care provider may not collect or attempt to collect from any subscriber or enrollee any money owed to the health care provider by a [hmo] .... a health care provider or any representative of a health care provider may not maintain any action against any subscriber or enrollee to collect or attempt to collect any money owed to the health care provider by a [hmo] .... ). 196 indiana health law review [vol. 8:171 tection against balance billing for emergency care services.216 the task force suggested that indiana enact something similar to california's regula­ tion of balance billing. 217 in 2006, the california court of appeal held that state law did not prohibit out-of-network providers to balance bill patients for emergency services.218 the california department of managed health care subsequently created a rule that declares that balance billing of hmo members for emergency services is an ''unfair billing pattem.'.z19 in january 2009, the california supreme court reversed the court of appeal's decision, holding that balanced billing of hmo subscribers is ille­ gal under california law when the provider has recourse to collect from the insurer.220 as previously discussed, california's regulations require insur­ ers to pay out-of-network providers a ''reasonable and customary value for the health care services.'.zz1 the california supreme court analyzed the issue of balance billing by considering whom the emergency room provider should involve when he or she disputes the ''reasonable and customary" amount paid by the insurer for services rendered.222 the court determined that the dispute should be between the provider and the insurer.223 in reach­ ing its conclusion, the court explained "a patient will have little basis by which to determine whether a bill is reasonable and, because the hmo is obligated to pay the bill, no legitimate reason exists for the patient to have to do so.''224 because of the nature of emergency care services, consumers have less choice as to who provides them medical care. for example, a consum­ er can generally choose which doctor to visit when he has a cold but may be unable to choose the emergency room to which an ambulance will take him. a prohibition on balance billing is appropriate in a situation where the emergency-care provider requires the patient to assign benefits, and where state law mandates the insurer to honor aob. a balance billing prohibition in this case would likely reduce ''wasteful disputes.'.zzs therefore, indiana legislators should consider a balance billing prohibition for emergency care services. 216. mani>atedliealthbenefittaskforce,supranote27. 217. id. 218. prospect med. grp., inc. v. northridge emergency med. grp., 39 cal. rpt. 3d 456 (cal. ct. app. 2006), rev'd, 198 p.3d 86 (cal. 2009). 219. cal. code regs. tit. 28, § l300.71.39(a)(2008). 220. prospect med. grp., inc., 198 p.3d at 92. 221. cal. code regs. tit. 28, § 1300.7l(a)(3)(b) (2008). 222. prospect med. grp., inc., 198 p.3d at 93. 223. /d. 224. id 225. see foust, supra note 48 (examining topic of aob and balance billing). 2011] state mandatory assignment of benefits legislation 4. indiana legislators should consider repealing the state's awplaw 197 indiana legislators should consider repealing the state's a wp law when they enact a mandatory aob statute.226 much of the indiana mandat­ ed benefits task force five-page report includes a chart of states comparing aob and a wp laws.227 in its analysis of the aob issue, the task force emphasized that only one state, georgia, has a broadly based a wp law and a broadly based aob law.228 therefore, it is reasonable to assume that the task force considers a wp and aob to be incompatible. some assert that the a wp law has "already severely damaged the ability of insurance networks to contain costs. "229 as previously discussed, opponents of mandatory aob argue that an aob law would exacerbate the problems for an insurer to manage costs.230 therefore, some insurers see the existence of an a wp and an aob law as two legislative measures that negatively affect their ability to manage networks.231 however, the bulk of the evidence shows that a mandatory aob law would not harm a payer's ability to control costs.232 nonetheless, repealing the a wp law may be a political compromise that could help ensure the passage of a mandatory aob law. for example, a health care policy expert at the indiana chamber of commerce states that he would not oppose aob legislation if the state would repeal its a wp law. 233 vi. conclusion the debate over whether patients should have the right to assign health insurance benefits to out-of-network providers includes interesting, yet competing, public policy arguments. this important issue has garnered the attention of state legislators around the country.234 requiring broadly applied, mandatory aob would likely have many advantages. perhaps the biggest benefit is ensuring that providers receive payment for their services 226. see supra part. ii.e.l {concerning background information on a wp). 227. mandated health benefit task force, supra note 27, at 2-3. 228. /d. at 4; see also ga. code ann. § 33-24-54 {2008) {aob law); ga. code ann. § 33-20-16 (2008) (awp law). 229. ind. health fin. comm'n, supra note 157, at 3; see also smith & stewart, supra note 62, at 1334-35 (examining awp laws and their effect on health care costs). but cf. interview with rinebold, supra note 52 {arguing that a wp does not harm an insurer's ability to maintain its network and health care costs because insurers can easily remove providers from their networks). 230. see generally supra part n.b. 231. interview with mike ripley, v .p ., health care pol'y, ind. chamber of commerce, in indianapolis, ind. (nov. 20, 2009) [hereinafter interview with ripley]. 232. see generally supra part v.a. 233. interview with ripley, supra note 231. 234. see, e.g.,ind. health fin. comm'n, supra note 81, at 3-4. 198 indiana health law review [vol. 8:171 so they can continue to provide care without raising their rates. 235 another important advantage to mandatory aob comes from the elimination of many of the administrative problems associated with payments and billings that providers and policyholders experieitce.236 however, many argue that mandatory aob would do significant harm to the health care system.237 a principal argument is that mandatory aob would weaken networks, which in turn would lead to higher costs for poli­ cyholders, their employers, and others.238 nonetheless, the empirical data related to this argument is weak. 239 in addition, there is evidence that man­ datory aob would do little, if anything, to weaken networks and increase health care costs overall.240 furthermore, legislators can structure laws to help protect against any harm by including a sunset provision.241 for the foregoing reasons, indiana should adopt a broadly applied, mandatory aob law. 235. see generally supra part ill.a. 236. see generally supra part iii.b. 237. see, e.g., letter from casey, supra note 135, at 1. 238. see generally supra part n.a-b. · 239. see supra part v.a. 240. see anderson, supra note 116, at 28. 241. see generally supra part v.b. history of the mcdonald-merrill­ ketcham memorial lecture and award the story of this award and lectureship begins with a visionary alumna of indiana university: dorothy m. ketcham. miss ketcham received her bachelor of arts in economics in 1914 and her master of arts in sociology the following year. she joined the faculty of the university ofmichigan in 1921. in 1922, she became director of social services at the university of michigan hospital. in this capacity, she saw the important role that medicine and law played in the lives of those whom she served. in 1928, she established a multifaceted workshop and recreational facility for children confined to the hospital. while at the university she also wrote several books, two of which are devoted to hospital law. miss ketcham's affinity for the law grew out of her family's close relationship with the legal system. her grandfather, david mcdonald, was a practicing attorney in indianapolis, as well as a circuit judge. he was appointed to the united states district court in 1864 where he served until his death. dorothy's father, william a. ketcham, was a well-known indianapolis attorney. prior to being admitted to the bar in 1869, he studied law with his father, john l. ketcham and judge david mcdonald. william ketcham was elected to the office of state attorney general in 1894 and served two terms. miss ketcham's interest in the health law extended beyond her scholarship. in a trust she established for herself and four of her sisters (miss flora mcdonald ketcham, dr. jane m. ketcham, and misses lilla and lucia ketcham), she made a remainder gift to the indiana university foundation to be used to assist the university in developing programs that would foster a greater understanding and better relations between the professions oflaw and medicine. miss ketcham was especially interested in furthering the careers of young medical and law students and instilling in them an appreciation for both professions. miss ketcham's generous gift, named for her grandparents (judge david mcdonald, john l. ketcham and jane merrill ketcham), funds this prestigious lectureship and award for an individual who has demonstrated excellence in the fields of common interest to the two professions. it is fitting that the university honor miss ketcham's wishes by bringing to our campus distinguished scholars and leaders who bridge the gap between law and medicine. by inviting them to share their expertise with students, faculty and leaders of the legal and medical professions, we continue to support the ideals that dorothy m. ketcham espoused in her life and work. in recent years, the lecture and award have been made in collaboration with the medical humanities program, a new interdisciplinary project based in the school of liberal arts. this addition further integrates law and medicine into the academic community and encourages each discipline to think of itself in relation to others. mcdonald-merrill-ketcham memorial lecture and award in conjunction with the indiana university school ofmedicine, the law school sponsors the annual mcdonald-merrill-ketcham memorial lectureship and award for excellence in law and medicine. supported by a bequest to the two schools, this lectureship and award brings leading scholars and policy makers in the fields of law and medicine to the indianapolis campus for the benefit of students, faculty, the bar and the medical community. the inaugural program was held in november 1994. award recipients and their articles are listed below. articles based on the lectures presented were published in the indiana law review until 2002, at which time the lectures started being published in the indiana health law review. • 1994-tom l. beauchamp, professor ofphilosophy and senior research scholar at the kennedy institute at georgetown university. the justification of physician-assisted deaths, 29 ind. l. rev. 1173 (1996). • 1996--frances h. miller, professoroflaw at boston university school of law and professor of public health at boston university school of medicine. health care information technology and informed consent: computers and the doctor­ patient relationship, 311nd. l. rev. 1019 (1998). • 1997-troyen a. brennan, professor oflaw and public health at harvard school of public health and professor of medicine at harvard school of medicine. beyond dead reckoning: measures of medical injury burden, malpractice litigation, and alernative compensation models from utah and colorado, 33 ind. l. rev. 1643 (2000). • 1998-barry s. levy, immediate past president of the american public health association and adjunct professor of community health at tufts university school of medicine. twenty-first century challenges for law and public health, 32 ind. l. rev. 1149 (1999). • 1999-bemard lo, professor of medicine and director of the program in medical ethics at the university of california, san francisco. confidentiality of prescription drug information in the era of computers and managed care, 331nd. l. rev. 937 (2000). • 2000--clark c. havighurst, william neal reynolds professor at the duke university school of law. the backlash against managed health care: hard politics make bad policy, 34 ind. l. rev. 395 (2001). • 2001-robert j. levine, professor of medicine and lecturer in pharmacology at yale university school of medicine. international codes of research ethics: current controversies and the future, 35 ind. l. rev. 557 (2002). • 2002-ruth r. faden, philip franklin wagley professor of biomedical ethics and executive director of the phoebe r. berman bioethics institute at johns hopkins university. liberty, public health, and national security: the challenge ofsmallpox, 1 ind. health l. rev. 1 (2004). • 2003-h. tristram engelhardt, jr., professor of philosophy at rice university, professor emeritus in the department of medicine at rice university, and professor emeritus in the department of community medicine at baylor college of medicine. giving, selling, and having taken: conflicting views of organ transfer, 1 ind. health l. rev. 29 (2004). • 2004-randall r. bovbjerg, research associate, health policy center, the urban institute, washington, dc. beyond tort reform: fixing real problems, 3 ind. healthl. rev. 1 (2006). • 2005-william m. sage, professor of law at columbia university. pay for performance: will it work in theory?, 3 ind. health l. rev. 301 (2006). dea c. lott dea c. lott is a clinical adjunct professor of law and the director out­ reach in the health and h~ rights clinic at the indiana university robert h. mckinney school of law. she is also employed as an attorney­ advisor for the u.s. social security administration. prior to her current positions, she was employed as a staff attorney at indiana legal services, inc. she has also worked for the u.s. immigration and naturalization ser­ vice, the indiana general assembly, the indiana court of appeals, and the indiana supreme court disciplinary commission. she is a graduate of in­ diana university robert h.· mckinney school of law. please note that she appears in her personal capacity and the views expressed are not the views of the u.s. social security administration. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i teaching holistic justice: medical-legal. partnerships in the clinical setting • deac.lott i. introduction ............................................................................... 549 ii. the structure of the heal til and human rights clinic .... 550 a. general structurethe medical-legal partnership ............... 550 b. specific structureclient-centered logistics .......................... 551 ill. common legal issues in the hhrc medical-legal partnership .................................................................................. 552 n. introduction to the practice in a medical-legal partnership .................................................................................. 553 v. bridging the gap between graduation and the practice: private bar involvement ......................................................... 555 vi. conclusion .................................................................................. 556 i. introduction clinical teaching has been part of the curriculum at indiana university robert h. mckinney school of law since 1982.1 until recently, the law school offered six clinics to students, the appellate clinic, the civil prac­ tice clinic, the criminal defense clinic, the wrongful conviction clinic, the disability clinic, and the immigration clinic, that provided students with the opportunity to provide legal services to more than three thousand clients.2 during the fall semester of 2011, the law school launched its newest clinical program-the health and human rights clinic ("hhrc"). this essay discusses several aspects of the hhrc, including the struc­ tural aspects of the hhrc, which necessarily requires a discussion of the hhrc's client population, the legal issues clients present to the hhrc, the hhrc's approach to student instruction and guidance in the clinical setting, * clinical adjunct professor of law & director of outreach, indiana university robert h. mckinney school of law, health and human rights clinic. please note that the views expressed in this writing do not represent the views of the social security administration or the united states government. they are solely the views of dea c. lott in her personal capacity or as representative of the health and human rights clinic at indiana university robert h. mckinney school of law. she is not acting as an agent or representative of the social security administration or the united states government in this activity. further­ more, there is no expressed or implied endorsement of views or activities ofdea c. lott, the health and human rights clinic, and the indiana university robert h. mckinney school of law by either the social security administration or the united states. l. about law school clinics, ind. univ. robert h. mckinney sch. of law, http://indylaw.indiana.edu/clinics/ qast visited may 11, 2012). 2. ld. 550 indiana health law review [vol. 9:2 the involvement of the private bar in the hhrc's work, and the future pro­ spects of the hhrc. ii. the structure of the heal til and human rights clinic a. general structure the medical-legal partnership the hhrc is based on the medical-legal partnership model in which medical institutions and legal service providers collaborate to address the healthcare and legal needs of vulnerable populations, address social deter­ minants of health, and seek to eliminate barriers to healthcare in order to help these populations meet their basic needs and stay healthy. 3 according to the national center for medical-legal partnership, the prevailing model of healthcare recognizes that adverse social conditions affect patient health. however, healthcare providers find that these adverse conditions are diffi­ cult to address because referrals to .social workers and case managers offer only limited assistance, and, although advocacy skills are valued, they are not consistently taught or provided in the prevailing model.4 the national center for medical-legal partnership states that the prevailing model of legal assistance relies on the individual to seek out legal help, provides cri­ sis-driven services, and is primarily focused on the pursuit of justice. 5 in contrast, the organization points out that the medical-legal partnership mod­ el encourages healthcare providers to prioritize advocacy skills, identify and address adverse social conditions curable by legal remedies as part of pa­ tient care, and work with social workers and legal service providers to ad­ dress legal needs, improve health, and change systems. 6 the medical-legal partnership model encourages attorneys to provide preventive services fo­ cused on early identification of and response to legal needs, utilize a healthcare team to help identify legal needs and make referrals for assis­ tance, and broaden the focus of legal assistance from pursuing justice to ensuring overall health and well-being.7 as discussed below, these benefits of the medical-legal partnership model are particularly true of the collabora­ tion between the health and human rights clinic and its health care part­ ner. 3. about us, nat'l crr. for med.-legal p'ship, http://www.medical­ legalpartnership.org/about-us (last visited may 11, 2012). 4. mlp: transforming healthcare and law, nat'l ctr. for med.-legal p'ship, http://www.medical-legalpartnership.org/mlp-modelltransforming-health-and-law (last visit­ ed may 11, 2012). 5. id 6. /d. 7. id 2012] teaching holistic justice: medical-legal partnerships 551 b. specific structureclient-centered logistics the specific structure of the hhrc's medical-legal partnership is best understood with more information about the hhrc's client population. the hhrc primarily serves the low income area approximately two miles west of the law school's campus, which is referred to as the near west area of indianapolis and includes the haughville, hawthorne, stringtown, and we care neighborhoods.8 according to the near west area website, 44% of the residents in this area are caucasian, 29% of residents are african american, 24% of residents are hispanic, and 3% are other races or ethnici­ ties.9 the residents in this area have low educational attainment levels, as studies have found that approximately 70% of residents in each of the neighborhoods have a high school diploma or less.10 additionally, in three of the neighborhoods, approximately 30% of all residents are living below the poverty level.ll the near west area's quality of life plan identifies quality education, affordable quality housing, public safety, and economic development as some of the primary needs for area improvement.12 the hhrc's health care partner, wishard hospital, operates the westside health center ("westside") in the near west neighborhood. westside provides the hhrc with access to office space within the health 8. neighborhoods, near w. indianapolis, http://nearwestindy.com/neighborhoods/ (last visited may 11, 2012). 9. civic engagement, near w. indianapolis, http://nearwestindy.com/quality-of­ life-planlcivic-engagement/ (last visited may 11, 2012). 10. community profile: hawthorne neighborhood association, sa vi. http://savi.org/ savi/communityprofi1es.aspx?geolocid = 18097341400 1j180973414002j180973415002& layerclass=54&boundaryid=886&selectedtab=education (last visited may 16, 2012); com­ munity profile: haughville community council, sa vi. http://savi.orglsavi/ communitypro­ files.aspx?geolocid= 180973411 001j18097341200lj180973412002j180973412003j 180973412004j180973415001jl8097341600ljl80973416002jl80973416003ll80973536006ll8 0973564001 &layerclass=54&boundaryid=885&selectedtab=education (last visited may 16, 2012); community profile: we care neighborhood association, sa vi. http://savi.org/savi/ communityprofiles.aspx?geolocid= 18097342600 1jl80973426005&layerclass=54& boundaryid=3176&se1ectedtab=education (last visited may 16, 20 12). 11. community profile: stringtown.org-economy, sa vi, http://savi.orglsavi/ communi­ typrofiles.aspx?geolocid= 180973564002j180973564003&layerciass=54&boundary id=997&selectedtab=economy (last visited may 16, 2012); community profile: hawthorne neighborhood association---economy, sa vi, http://savi.org/savi/communityprofiles.aspx?geolocid= 18097341400 ljl80973414002j180973 415002&layerclass=54&boundaryid=886&selectedtab=economy (last visited may 16, 2012); community profile: haughville community council-economy, sa vi. http://savi.orglsavi/communityprofiles.aspx?geolocid=l809734110011180973412001j180973 4t2002i180973412003jt80973412004ii8097341500tll809734i600tlt809734t6002ii809734t60 03jl80973536006j18097356400 l&layerclass=54&boundaryid=885&selectedtab=economy (last visited may 16, 2012); community profile: we care neighborhood association-economy, sa vi, http://savi.org/savi/communityprofiles.aspx?geolocid=l8097342600lll809734 26005&layerclass=54&boundaryid=3176&selectedtab=economy (last visited may 16, 2012). 12. quality of life plan, near w. indianapolis, http://nearwestindy.com/quality-of­ life-planl (last visited may 11, 2012). 552 indiana health law review [vol. 9:2 center, office equipment, and interpreters to accommodate client intake and meetings. the lllirc collaborates with westside's physicians, medical assistants, social workers, financial counselors, and other support staff to identify the legal needs of patients who may ultimately become lllirc cli­ ents. westside's staff not only provides health care services, but also as­ sesses patient eligibility for various low or no cost hospital services and government healthcare programs. the lllirc provides regular training to and maintains ongoing communication with the staff at westside to guide them in the identification of legal needs during patient interaction.13 when meeting with patients, the staff inquires about the non-medical stressors and concerns affecting patients and, thereafter, provides referrals to the hhrc. the lllirc maintains a weekly presence at westside and may interact with prospective clients at the time of the referral, or staff may send referrals to the law school so that the hhrc may arrange to meet with prospective cli­ ents at westside at a later date. this provides prospective clients with a one-stop shop for medical, legal, and social services ·located within their community for maximum accessibility. the lllirc's limited resources are utilized most efficiently and effec­ tively when westside provides case referrals; therefore, this is preferred over self-referral from clients. as discussed above with respect to medical­ legal partnerships generally, the hhrc has found that referrals from westside staff are more efficient because the staff filters medical issues and social service needs to appropriate staff within the health center, thereby providing the hhrc with referrals that involve only legal issues, often­ times well before any administrative agency or court involvement. this process enables the hhrc to engage in preventive lawyering, whereby le­ gal problems may be resolved quickly and with less contention, the pro­ spect of litigation is often curbed, and the degree of client stress is significantly lessened. in contrast, when the hhrc accepts self-referrals from prospective clients, the problem presented may not be a legal issue or, if a legal issue is presented, the prospective client often seeks help when the situation is dire and options for resolution of legal issues are substantially limited. iii. common legal issues in the hhrc medical-legal p ar1nership the hhrc receives referrals for a variety of legal issues. as ex­ pected in a healthcare setting, the clinic receives many requests for drafting of advance directives for disabled or terminally ill clients. there is a con13. indiana health advocacy coalition, nat'l ctr. for med.-legal p'ship, http://www.medical-legalpartnership.orglmlp-networklregional-collaborations/indiana­ health-advocacy-coalition (last visited may 11, 2012) (the health and human rights clinic is also part of the indiana health advocacy coalition, a non-profit organization that pro­ motes health advocacy services throughout the state of indiana.). 2012] teaching holistic justice: medical-legal p arlnerships 553 stant stream of uninsured or underinsured patients seeking assistance in de­ termining eligibility for and appealing denials or terminations of govern­ ment health and disability programs. there are also numerous. requests for assistance with food benefit and housing assistance programs. in addition, the hhrc receives many referrals for assistance with addressing substand­ ard rental housing conditions and violations of installment contracts for the purchase of real property. to a lesser degree, the hhrc receives requests for assistance with protective orders and consumer law issues. in response to these requests, the hhrc provides strategic and crea­ tive solutions to assist clients. because the hhrc receives many referrals before legal issues fully develop and become highly contested, many refer­ rals are resolved by providing counsel and advice to clients-which, in turn, empowers the client to take appropriate steps to remedy their problems with an opportunity to seek additional assistance from the hhrc where neces­ sary. for example, a client may be referred to the hhrc because he is re­ ceiving harassing telephone calls from debt collectors that are contributing to his anxiety disorder. in this situation, students at the hhrc may advise the client that federal law requires debt collectors to stop contacting him if he sends them a letter informing each debt collector that he does not want them to contact him by telephone. if the client sends these letters, but a debt collector continues to call him, he may seek additional help from the hhrc to take action against the debt collector. in addition, many cases require only brief services involving cease and desist letters that remedy problems before tempers flare and before litigation becomes inevitable. drafting services are frequently provided to clients, not only for purposes of drafting advance directives, but also to assist clients in preparing corre­ spondence to adverse parties in order to resolve their problems without cre­ ating the tension that arises when an adverse party knows legal counsel is involved. moreover, the hhrc provides full representation for clients in cases that lead to administrative hearings or where litigation has become inevitable. where appropriate, the hhrc also advocates for changes in public policy to address systemic issues. n. introduction to tile practice in a medical-legal partnership each student enrolled in the hhrc is required to attend a full day ori­ entation that provides an overview of the clinical practice of law, medical­ legal partnerships, poverty simulation exercises, case management, and pro­ fessional ethics in general and with respect to medical-legal partnerships. class sessiot;1s explore the mechanical aspects of the practice of law through intake and initial interview simulations and discussions of case planning, interviewing, counseling, negotiation, policy advoca.cy, and stress manage­ ment practices. class meetings also expose students to the dynamics of poverty and concepts of holistic justice through broader discussions of pov­ erty in the united states, the social determinants of health, international 554 indiana health law review [vol. 9:2 health and human rights, access to justice in central indiana, education and disability law, access to safe and affordable housing, public benefits, em­ ployee rights, and consumer matters. the hhrc students begin their work in our office at westside within two weeks of the start of the semester and they maintain regular office hours that can be used for intake evaluations or client appointments. when case referrals from westside are suitable for teaching students, the hhrc's clients communicate solely with students. language barriers arise frequent­ ly in such a diverse client population, so westside provides interpreters in person or by phone to allow for communication between the students and clients. in addition, the hhrc hires qualified students to translate written client correspondence. while the hhrc faculty makes regular visits to its westside office during student office hours,. the students interact with prospective clients and work with the staff at westside as colleagues to collaborate in resolving urgent problems clients are facing when they arrive at the health center. for example, when a prospective client is referred to the hhrc because her medicaid is terminated, during the course of the intake interview, the pa­ tient may emphasize to the student that they cannot afford their prescription medication while they wait to appeal the termination. in this situation, the student may contact the social worker at westside to learn about programs that may provide the client with prescription medications on a temporary basis. meanwhile, the student may begin drafting an appeal for the client and, after consultation with a faculty supervisor, fax the appeal from westside. thereafter, the client leaves the health center after receiving treatment and medications, appealing the termination of their medicaid benefits, and meeting with the student who will be working on their case. once students are back in the classroom, they discuss the successes and challenges they face with their cases. the hhrc requires students to provide weekly reflections of their learning experiences and a self­ evaluation during the middle of the semester. these assignments ask the students to pause for a moment to analyze their preexisting -notions about the practice of law, their individual learning experiences, their clients, the issues they are working on, and the areas where they need to improve. the­ se assignments are tremendously helpful to the hhrc faculty· in guiding students in handling clients, cases, and the stressors ·of transitioning from student to practitioner. case discussions and weekly reflections also help the hhrc faculty identify areas where additional instruction is needed. for example, during the fall semester, several students were disappointed to find. that many clients were difficult to assist due to disconnection of tele­ phone service, frequent address changes, homelessness, and missed ap­ pointments. · because· of this, the hhrc faculty became concerned that these experiences were unfairly reinforcing negative stereotypes about poor clients. in response, the hhrc is exploring the possibility of involving students in a poverty simulation exercise in which students take on the per2012] teaching holistic justice: medical-legal p ar1nerships 555 sona of a fictional impoverished client. students will be provided with de­ tails of their persona's personal and family history, a description of the so­ cial or legal problems that the persona is enduring, and a task list to complete in the near west area using only the public transportation sys­ tem. the implementation of this exercise has been delayed in order to as­ sess the safety measures that need to be in place before· this exercise can be fully integrated into the syllabus. the hhrc's classroom component also focuses on peer education, community education, and policy advocacy. some students are asked to conduct research into legal issues related to their cases and develop a presentation of these issues for their peers. these presentations have sparked deeper discussion of issues and students have found these presenta­ tions helpful when they subsequently explore similar issues in their own cases. similarly, other students are asked to research pressing legal issues of interest to the near west area in general, develop presentations and handouts, and deliver this information to resident groups as a method of client empowerment. with respect to public policy, each student must iden­ tify systemic problems that negatively impact the client population in the local community and write a brief on the topic. this exploration of public policy is discussed throughout the course and these discussions have led to student involvement in meetings with the local health department to advo­ cate for a change to the health code and submission of an amicus brief on violations of procedural rights in indiana's small claims courts. v. bridging the gap between graduation and the practice: private bar involvement during the spring semester, the hhrc launched a pilot pro bono pro­ gram, the health and human rights clinic outreach initiative ("outreach initiative"). this program is designed to establish a system of outreach and coordination for pro bono attorneys as one of the core. components of the hhrc. the outreach initiative assists newly admitted attorneys with the transition from law school to practice by giving them an opportunity to gain practice experience from representing pro bono clients. however, the fea­ tures of this program also assist practitioners, of any experience level, with addressing the social and legal issues unique to impoverished and under­ served populations. under this pilot program, the hhrc recruits and trains pro bono at­ torneys in handling its cases, provides malpractice insurance coverage, screens prospective clients and issues before case referral, and matches at­ torneys with cases received from westside and local nonprofit legal service agencies. pro bono attorneys perform all case handling duties for these cases; however, this program differs from the existing pro bono programs in indianapolis by taking the next logical step to offer ongoing support to pro bono attorneys throughout the representation of clients and provide ad556 indiana health law review [vol. 9:2 ditional opportunities for training from attorneys experienced in issues that impact the health and well-being of impoverished clients. the indianapolis bar foundation provided the initial funding to estab­ lish the pilot of this program and individual members of the private bar have also expressed a strong interest in the program. to date, the hhrc has trained more than thirty attorneys from a variety of experience levels and practice areas. several more attorneys are awaiting our subsequent training sessions and the opportunity to represent clients with the support offered by the hhrc. additionally, representatives from multiple private law firms have expressed an interest in working with the hhrc to provide pro bono services to clients in the indianapolis area. furthermore, several private attorneys, nonprofit legal service providers, including other medical­ legal partnerships throughout the area, have referred prospective clients to the hhrc for possible representation. at this time, this program is only is funded through the fall of 2012. however, the hhrc is seeking support to make this program a fixture of the clinical programs at the indiana university robert h. mckinney school of law. the hhrc hopes to develop this program into a best­ practices model of legal education that will provide newly admitted attor­ neys and seasoned professionals throughout the indianapolis community with an opportunity to develop legal practice skills, diversify their existing skills, and learn from experienced practitioners in an academic setting while expanding crucial legal services to vulnerable populations throughout cen­ tral indiana. vi. conclusion the hhrc's :fusion of the medical-legal partnership model with clini­ cal teaching challenges each student to consider the health, social, and legal needs of their clients with the goal of exposing students to the concept of holistic justice. while the hhrc's outreach initiative also introduces pro bono attorneys to holistic justice, the program emphasizes the practical skills needed to address the vast need of indianapolis's impoverished com­ munity. although the hhrc utilizes different approaches with students and pro bono attorneys, the overarching goal is the same. the hhrc hopes that, as students and pro bono attorneys endeavor to understand the plight of their clients and the systemic factors that influence their health issues, socioeconomic status, and legal problems, these experiences will lay the foundation for a generation of lawyers who are able to identify the im­ pact of law and public policy on vulnerable populations and who, more im­ portantly, are better equipped to challenge injustices as they arise. a flawed solution to the sex offender situation in the united states: the legality of chemical castration for sex offenders matthew v. daley• table of contents i. introduction ...................................................................................... 88 ii. the evolution and history of castration ................................. 89 ill. depq-provera: the latest metiiod of chemical castration ..................................................................................... 91 a. how depo-provera worh ........................................................... 91 b. the side-effects ofdepo-provera ................................................ 92 c. depo-provera 's limitations: how they affect any potential statutory implementations ......................................................... 93 iv. chemical castration: the constitutional implications ......... 94 a. eighth amendment problems ....................................................... 94 1. is chemical castration treatment or punishment? .............. 94 2. is chemical castration cruel and unusual punishment? .... 98 3. the issue of consent ........................................................... 101 b. the equal protection claim ...................................................... 102 1. the strict scrutiny standard and its requirements ............ 102 2. the intermediate scrutiny argument in regards to chemical castration ...................................................... 103 3. rational basis review: its result when applied to chemical castration .......................................................................... 104 c. the problem of double jeopardy ............................................. 105 v. current state statutes and their inherent flaws ................. 106 a. california's chemical castration statute ................................. 106 b. montana's chemical castration statute ................................... 109 c. florida's chemical castration statute ..................................... 112 d. louisiana's chemical castration statute ................................. 114 e. oregon's chemical castration statute ..................................... 117 f. overall problems with the chemical castration statutes now in effect .............................................................. 119 g. europe's approach to chemical castration ............................. 120 vi. conclusion ....................................................................................... l21 • j.d. candidate, 2008, indiana university school oflawindianapolis; b.s., 2005, indiana universitybloomington. 88 indiana health law review [vol. 5:87 i. introducfion prisons in the united states are being inundated with new prisoners at an alarming rate. indeed, in some cases the influx of prisoners is so great that many prisons are either becoming full or dangerously overcrowded. given the severe overcrowding facing prisons today, state and federal governments are under enormous pressure to find a way to provide relief for the system while still keeping truly dangerous criminals from being released back into society. one way governments are addressing the problem is by tackling recidivism. recidivism occurs when an inmate, after being released from prison, commits another crime or perhaps even the same type of crime, is rearrested, and placed back in jail. almost all categories of crimes have a problem of recidivism, including crimes involving sex offenders. one study found that child molesters had a 36.9 % recidivism rate while rapists had a 46.2 %rate nationally.1 this means that more than one in three child molesters will commit a crime again while close to half of all rapists will commit another crime upon being released. in efforts to try to reduce this number, states have instituted a plethora of options. one of the most popular options is the civil commitment of sex offenders upon their release. 2 this option .keeps dangerous sex offenders off the streets and eliminates the risk that they will re-offend. however, aside from the constitu­ tional problems inherent in such a solution, the cost is extremely high. 3 it costs on average $26,000 a year to keep someone in prison, while it costs on average over $100,000 a year to civilly commit a sex offender under this concept.4 this high cost, along with the increasingly over-crowded status of prisons, has in­ creased the pressure placed on government agencies to keep sex offenders from becoming recidivists while at the same time avoiding the necessity of keeping them locked up for the rest of their lives. responding to this pressure, several states including califomia,5 mon­ tana, 6 and oregon, 7 have created statutes that require chemical castration, as a prerequisite of release, in certain cases. the underlying concept is that by eli­ minating the sex drives of these offenders, they will be unable or unwilling to commit another crime; thereby, increasing the likelihood of their becoming 1. ctr. for sex offender momt., recidivism for sex offenders 11 (may 2001 ), available at http://www.csom.org/pubs/recidsexof.pdf (hereinafter recidmsm for sex offenders]. 2. monica davey & abby goodnough, doubts rise as states hold sex offenders after prison: costly efforts keep ex-convicts off streets, but mandated treatment often fails, n.y. times, mar 4, 2007, at ai [hereinafter doubts rise as states hold sex offenders]. · 3. id. 4. id. ata18. 5. cal. penal code§ 645 (1998). 6. mont. code ann.§ 45-5-512 (1998). 7. or. rev. stat. 144.625 (1998). 2008] the legality of chemical castration 89 productive members of society. the concept of chemical castration, however, runs afoul of several constitutional provisions and creates a multitude oflegal issues. this note will address the problems inherent in the chemical castration model. part ii of this note will discuss the history of castration and the forms that have evolved over the years in world-wide systems of justice. part iii will examine the latest method of chemical castration, a drug called depo-provera, and its effects on the body. part iv will address overarching constitutional problems. finally, part v will discuss the flaws inherent in state statutes that currently provide chemical castration as a parole tool, and briefly analyze how europeans have approached the castration of sex offenders. all of these parts will demonstrate why chemical castration is not an effective parole tool. ii. the evolution and history of castration the idea of castration as a punishment did not originate in the united states. it was, in fact, around for centuries before america was even colonized. for example, in ancient times conquering armies would often castrate their captives as punishment for daring to be their enemies. 8 one of the first uses of castration in the united states occurred during the 1800's, "when slaves were routinely castrated as a punishment if suspected of having relations with white women. "9 however, the official castration of prisoners as a punishment in the united states truly began around 1899.10 it was also around this time that the concept of eugenics first took root in the united states. 11 the eugenics move­ ment is devoted to improving the human species through the control ofheredi­ tary factors in mating. 12 the essential goal of this movement is to control the gene pool from which children are created by making sure that supposedly ''weaker" people do not procreate. 13 eugenics led to a movement in which women and men who were convicted of crimes were sterilized to prevent their weaker genes from entering into the human gene pool.14 during the early 1900's, over 60,000 incarcerated or mentally handicapped women were steril­ ized, in accordance with state statutes, and in the name of the eugenics move­ ment.15 8. william l. baker, comment, castration of the male sex offender: a legally im­ permissible alternative, 30 loy. l. rev. 377, 379 (1984). 9. kris w. druhm, note, a welcome return to draconia: california penal law§ 645, the castration of sex offenders and the constitution, 61 alb. l. rev. 285,286-87 (1997). 10. louis lemaire, danish experiences regarding the castration of sexual offenders, 47 j. crim. l. criminology &police sci. 294,294 (1956). 11. id. 12. webster's new world dictionary 468 (3rd ed. 1970). 13. david morgan, yale study: us eugenics paralleled nazi germarty, reuters (feb. 15, 2000), available at http://www.hartford-hwp.com/archives/45/302.html (last vis­ ited mar. 15, 2008). 14. id. 15. druhm, supra note 9, at 287. 90 indiana healni law review [vol. 5:87 soon, prisoners and their families began challenging the existing statutes, arguing against the constitutionality of these sterilization procedures. eventu­ ally, this issue went before the united states supreme court in the case of buck v. bell. 16 in that case, a feeble-minded eighteen year-old woman whose mother was also supposedly feeble-minded was convicted of a crime and then sterilized pursuant to a virginia law.17 the supreme court ruled that the.statute was con­ stitutional stating, "it is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for .the imbecility, society can prevent those who are manifestly unfit from continuing their kind. "18 this opinion has never been overturned, though it has been limited over the years, 19 and in fact almost every state continues the practice of sterilizing the mentally retarded in certain circumstances.20 ironically, the eugenics movement caught the interest of an aspiring aus­ trian politician who is today held in ill-repute: adolf hitler. indeed, hitler based his original political movement, the movement that led to the holocaust, on the eugenics movement then present in the united states. 21 he :freely admit­ ted his inspiration came from the united states, and was once quoted as saying: now that we know the laws ofheredity ... it is possible to a large extent to prevent unhealthy and severely han­ dicapped beings :from coming into the world. i have stu­ died with interest the laws of several american states concerning prevention of reproduction by people whose progeny would, in all probability, be of no value or be injurious to the racial stock. 22 hitler used the american system as both model and justification for the mil­ lions of deaths he caused, and he was actually praised in the beginning by vocal members of the american eugenics movement. 23 joseph dejarnette, at one time the superintendant of virginia's western state hospital, actually once complained that, "[t]he germans are beating us at our own game.'.z4 given this history, is it any wonder that americans find statutorily mandated castration so 16. buck v. bell, 274 u.s. 200, 200 (1927). 17. jd.at205. 18. id. at 207. 19. robert d. miller, forced administration of sex-drive reducing medications to sex offenders: treatment or punishment?, 4 psychol. pub. pol'y & l. 175, 182 (1998). 20. gerard s. leterrie & wiuiam f. fox, legal aspects of involuntary sterilization, 53 fertility & sterility 391, 391 (1990). 21. edwin black, hitler's debt to america, the guardian, feb. 2004, available at http://www.waragainsttheweak.com/oft:sitearchive/hitlerdebttoamerica.html (last visited mar. 15, 2008). 22. id. 23. ld. 24. id. 2008] the legality of chemical castration 91 disconcerting? as dr. fred berlin once said, "even the mention of castration has an ugly, jarring sound to it."25 iii. depo-provera: the latest method of chemical castration the current method of chemical castration used in almost every state that approves of the procedure relies on the drug antiadrogen synthetic progester­ one, known also as depo-provera, depot medroxyprogesterone acetate, and mp a.26 this drug ''was first synthesized in 1954 [by the upjohn company] and was initially introduced in 1959 as a treatment for gynecological disor­ ders.'m depo-provera was first used as an effective way to reduce men's sex drive in 1958.28 however, questions arose as to potential long term effects of depo-provera, and in 1974 the food and drug administration ("fda") with­ drew their approval for all uses of depo-provera.29 this ban lasted nearly twenty years, but on october 29, 1992 the fda again approved depo-provera for use in the united states. 30 at that time, however, the fda specifically lim­ ited the use ofdepo-provera to "the prevention ofpregnancy''.31 a. how depo-provera works in the context of castration, depo-provera is administered as a weekly in­ tramuscular injection in either the arm or the buttocks in a dose of approxi­ mately 500 milligrams. 32 depo-provera lowers testosterone levels by (1) increasing testosterone metabolism by the liver and (2) decreasing the amount of luteinizing hormone ("lw') and follicle-stimulating hormone ("fsh") re­ leased.33 to aid this hormone decrease, depo-provera inhibits the release of lh and fsh from the anterior pituitary gland of the brain. 34 it also "works by induction of the enzyme testosterone-a-ring-reductase in the liver, accelerating the breakdown and elimination oftestosterone."35 depo-provera lowers testos­ terone levels, causing the subject to experience a decrease in sex drive, a reduc25. stacy russell, comment, castration of repeat sexual offenders: an international comparative analysis, 19 hous. j. int'l. l. 425, 440 (1997). 26. william green, note, depo-provera, castration, and the probation of rape of­ fenders: statutory and constitutional issues, 12 u. dayton l. rev. 1, 3 (1986). 27. philip j. henderson, note, section 645 of the california penal code: california's "chemical castration" law-a panacea or cruel and unusual punishment?, 32 u.s.f. l. rev. 653, 654 (1998). 28. /d. 29. warren e. leary, u.s. approves injectable drug as birth control, n.y. times, oct. 30, 1992, at al. 30. henderson, supra note 27, at 655. 31. physician's desk reference 2080 (51st ed. 1997) (hereinafter pdr]. 32. marsha weissman & richard luciani, sentencing the sex offender: a defense perspective, crim. l. & urb. probs. 259,270 (1989). 33. miller, supra note 19, at 182. 34. /d. 35. !d. 92 indiana health law review [vol. 5:87 tion in sperm product, fewer erections, and a reduction in ejaculations while he is under the effects of the drug. 36 as the dosage level increases, so does the reduction of testosterone and the ability to sustain erections. 37 b. the side-effects ofdepo-provera in studies ofdepo-provera, both those studies done for fda approval and other later studies, an array of side effects were reported. in the short-term, subjects reported weight gain, hyperinsulinemic response to glucose, diabetes mellitus, irregular gall bladder functioning, diverticulitis, fatigue or lethargy, testicular atrophy, sweats, nightmares, dyspnea, hypogonadism, hot and cold flashes, leg cramps, hypertension, thrombosis, insomnia, elevated blood sugar, shortness of breath, and lessened testis size.38 all listed side effects were shown to disappear when depo-provera was disused; however, it could take up to six months for full sexual functioning to return. 39 it is important to note that the studies on side effects and the duration of the side effects were all based upon depo-provera's use as a female contraceptive.40 the amount ofdepo­ provera "used to reduce testosterone in men is, on the average, over forty-three times more than what is given to woman as a contraceptive."41 considering this fact, it is unclear whether the side effects that may be temporary in women could ultimately be more severe and/or permanent in male sex offenders. beyond the short-term side effects, there is evidence that depo-provera may have long-term effects. depo-provera "may be considered among the risk factors for development of osteoporosis. '.42 also, long term usage by sex of­ fenders can cause massive weight gain and the formation ofbreasts.43 in addi­ tion, some studies believe that depo-provera may be a carcinogen in animals; there is some evidence that depo-provera causes breast cancer in both beagles and monkeys. 44 but there is no evidence currently in existence and known to the general community that shows humans are at risk for cancer from depo­ provera. in fact, the fda found that "although early animal studies had raised questions about increased breast-cancer risk, numerous later worldwide studies have found the overall cancer risk in humans to be minimal, if any.'.45 most of 36. pamela k. hicks, commentary, castration of sexual offenders, 14 j. legal med. 641,646 (1993). 3 7. john money, treatment guidelines: antiandrogen and counseling of paraphilic sex offender, 13 j. sex. &marital therapy219, 220 (1987). 38. miller, supra note 19, at 182. 39. id. 40. henderson, supra note 27, at 656. 41. id. 42. pdr. supra note 31, at 2080. 43. monica davey & abby goodnough, for sex offenders, dispute on therapy bene­ fits, n.y. times, mar. 6, 2007, at al8 [hereinafter dispute on therapy benefits]. 44. edward a. fitzgerald, note, chemical castration: mp a treatment of the sex offender, 18 am. j. crim. l. 1, 8 ( 1990). 45. leary, supra note 29, at ai. 2008] the legality of chemical castration 93 these studies, however, focused on women and the effects ofdepo-provera on them. very little is known about possible health threats posed when the dosage ofdepo-provera is increased to the levels used to suppress the sex drives in male sex offenders simply because usages for that purpose have not been stud­ ied. this makes it difficult to assess what, if any, long term effects constant high dose depo-provera usage would have on the human body, or how long the changes caused by depo-provera injections would last once the injections were stopped. c. depo-provera 's limitations: how they affect any potential statutory implementations beyond the long list of potential side effects, depo-provera, as a cure all for sex offenders·, is further limited by the types of sex offenders for which it may provide a useful benefit sex offenders can be divided into four types. type i de­ nies the commission of the crime or the criminal nature of the act. type ii confesses to the commission of the crime, but places the blame for the crime on nonsexual or non-personal forces, such as alcohol, drugs, or stress. type iii is the violent criminal who is motivated by nonsexual gain, such as anger, power, or violence. type iv is the paraphiliac who exhibits a pattern of sexual arousal, erection, and ejaculation, which is characterized by a specific fantasy or its actualization.46 depo-provera can only truly be effective if the reasons behind the sexually based crime stem from sexual desire or have some sexually based rationale. after all, if sex drive was the cause, depo-provera's ability to reduce a person's sex drive could in theory be effective. type i, ii, and iii sex offenders do not, however, have a sexual motivation!7 rather, a nonsexual motive drives these individuals to commit a sexual offense.48 it is poor policy to release a sex of­ fender whose motivation is not sexual desire and then hope depo-provera will reduce sexual ability and thus lower recidivism. perhaps that is why a recent study that followed the release of certain sex offenders found that while only twenty-eight percent were reconvicted for sexual offenses, forty-three percent were reconvicted for a violent, nonsexual offense.49 in addition to depo-provera only having a real chance of working for type iv sex offenders, depo-provera alone is not truly effective. to have a 46. fitzgerald, supra note 44, at 4. 47. id. 48. id. 49. recidmsm for sex off'enders, supra note 1, at 8. 94 indiana health law review [vol. 5:87 realistic chance ofbeing effective, depo-provera needs to be linked and used in tandem with psychological treatment on those that have a potential for being helped by the drug. 50 a recent study found that a significantly higher percent­ age of sex offenders given treatment along with drug options experience a lower recidivism rate than those given just the drug. 51 therefore, any statutory requirement of chemical castration, as a parole condition, must not only be very limited in its use and create a great deal of discretion in its application, it must also require, or at least encourage, some form of therapy to go in tandem with depo-provera. iv. chemical castration: the constitutional implications chemical castration as a general concept raises several important constitu­ tional issues that must be considered and addressed before any statute or law can be created that is constitutional on its face. a. eighth amendment problems perhaps the greatest constitutional hurdle facing the usage of chemical ca­ stration on sex offenders is the eighth amendment. this amendment states "[e]xcessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted. "52 several legal issues arise when applying this amendment to the concept of chemical castration. 1. is chemical castration treatment or punishment? in order for chemical castration to be considered under an eighth amendment analysis, it must first be determined whether chemical castration is a punishment. if it is a punishment, it falls under the purview of the eighth amendment. conversely, if it is treatment, it lies outside the scope of the eighth amendment. given its long list of side effects and the adverse effect it has on the male sex drive, depo-provera could easily be seen as a punishment by people outside of the legal or psychiatric communities. however, just be­ cause depo-provera can be seen as a punishment by some, that fact does not automatically make the statutorily mandated use ofdepo-provera a punishment suitable for an eighth amendment analysis. after all, ''the emotional reaction engendered by criminal sexual behavior makes it unlikely that society will ac­ cept treatment as a sentencing option unless it is clearly viewed as punish50. john b. murray, psychopharmacological therapy of deviant sexual behavior, 115 j. gen.psychol. 101, 107 (1988). 51. recidmsm for sex offenders, supra note 1, at 13 (finding a 7.2% recidivism rate for sex offenders who participated in relapse prevention treatment programs used in conjunction with depo-provera compared to a 17.6% rate when only depo-provera was used). 52. u.s. const. amend. xviil 2008] the legality of chemical castration 95 ment. "53 therefore, the only real way to provide treatment to sex offenders is to cloak the treatment in the aura of punishment to get it past people outside the legal community. while the legal community's view is important, however, other views must also be considered when determining depo-provera' s status. specifically, the psychiatric community's view ofdepo-provera is important in making this critical determination. within the psychiatric community, treatment with depo-provera is viewed as a viable way to reduce sex drives. however, some members of the commu­ nity are disturbed by the concept of statutorily mandated depo-provera usage by parolees. dr. robert d. miller wrote on this subject: it is important to recognize that the only clinically ap­ propriate use of all these medications with sex offenders is to reduce abnormally excessive sexual drives or fanta­ sies, not to render the patient impotent. therefore, the very phrase chemical castration implies a medically in. appropriate use of the medications. to use such medica­ tions to reduce future illegal sexual behavior, especially in an involuntary fashion, is not treatment any m~ than is incarceration. 54 this is an indication that there is some disagreement and unrest among the psy­ chiatric and medical communities on whether depo-provera is a treatment or a punishment. though the opinion of the medical community and that of the average person could be an influence on the question of treatment or punishment, the real underlying question is whether or not chemical castration meets the legal standard to qualify as treatment. first, it is almost irrelevant whether a statute specifically states that a specific course of action is for treatment or for punish­ ment. the supreme court has held that the mere characterization of an act as ''treatment" does not insulate it from eighth amendment scrutiny. 55 instead, an inquiry must be made directed towards the substance, since"[ e ]vena clear leg­ islative classification of a statute as 'non-penal' would not alter the fundamental nature of a plainly penal statute. ,,56 before making any inquiry into a particular statute or concept, however, it is important to understand what standard it will be compared to in order to decide if it violates the eighth amendment. 53. berlin and malin, media distortion of the public's perception of recidivism and psychiatric rehabilitation, 148 am. j. psychiatry 1572, 1572 (1991); see also daniell. icenogle, sentencing male sex offenders to the use of biological treatments: a constitu­ tional analysis, 15 j. legal men. 279,280 (1994). 54. miller, supra note 19, at 183. 55. trop v. dulles, 356 u.s. 86, 95 (1958). 56. id. 96 indiana health law review [vol. 5:87 the applicable standard in this situation was first articulated in the case of rennie v. klein. 57 in that case, an involuntary mental patient in new jersey argued that he had the right to refuse medication since this was a non­ emergency situation and that to force medication on him would qualify as cruel and unusual punishment under the eighth amendment. 58 the court in rennie reviewed both the evidence at hand and the factors considered by previous su­ preme court cases when determining the crucial question of treatment or pun­ ishment. the court then outlined the following four prongs that must be shown to make a determination on whether a medical action qualifies as treatment: (1) whether the procedure has any therapeutic value; (2) whether the procedure is part of an accepted medical practice or is experimental in nature; (3) whether the adverse effects of the procedure seem unduly harsh; and (4) whether the procedure is "part of an ongoing psychotherapeutic program."59 under the first prong of the test, chemical castration may qualify. there is some evidence that depo-provera, used in conjunction with therapy and other psychological techniques, may be beneficial to a patient.60 a recent study of the recidivism rates among sex offenders did show a decrease when depo­ provera was used. 61 however, it is difficult to be certain of those rates, as there are some problems that seem inherent when collecting data in the area of sexual offenses. first, very few of the overall total sexual offenses are reported.62 for example, a recent study found that only twelve percent of actual rapes are re­ ported. 63 another study found that actual numbers of sexual offenses could be as much as 2.5 times as high as reported. 64 since these types of offenses are so under-reported, it is probable that some repeat offenders using depo-provera exist, but these repeat offenses are not reported. the second prong of the test is whether the potential treatment is an ac­ cepted medical practice, and under this prong chemical castration will likely succeed. though the specific usage ofdepo-provera as a condition of parole or as an additional punishment may not be generally accepted in the psychiatric community, the use ofdepo-provera is a generally accepted medical practice. the medical community considers it an effective way to reduce abnormally ex­ cessive sexual drives or fantasies, 65 and to provide a way to treat people suffer­ ing from some mental illnesses when used in conjunction with treatment. 66 one psychiatrist said, "[c]onsequently, since the source of pedophile's behavior is 57. renniev. klein, 462 f.supp 1131, 1131 (d.n.j.1978). 58. !d. at 1143. 59. !d. 60. recidivism for sex offenders, supra note 1, at 11. 61. !d. 62. ctr. for sex offender mgmt., my1hs and facts about sex offenders (aug. 2000), http://www.csom.org/pubs/mythsfacts.html (last visited mar. 15, 2008). 63. !d. 64. recidivism for sex offenders, supra note 1, at 11. 65. miller, supra note 19, at 183. 66. money, supra note 37, at 220. 2008] the legality of chemical castration 97 biological, depo-provera is very effective because it suppresses their unaccept­ able sexual urges by decreasing the testosterone levels that drive them.'.67 since there are some accepted instances when depo-provera is effective, it would likely be considered an accepted medical practice generally. however, the cur­ rent application ofdepo-provera as a parole condition would likely not be con­ sidered an effective medical use for the drug. in this context, dr. robert miller stated: it is important to recognize ... that the only clinically appropriate use of all these medications with sex offend­ ers is to reduce abnormally excessive sexual drives or fantasies, not to render the patient impotent. therefore, the very phrase chemical castration implies a medically inappropriate use of the medications. to use such medi­ cations to reduce future illegal sexual behavior, espe­ cially in an involuntary fashion, is not treatment any more than is incarceration. 68 the third prong of the test is whether the supposed treatment is unduly harsh, and chemical castration likely fails to qualify as treatment under this prong. depo-provera has a very long list of potential side effects, and some of them, such as diabetes mellitus and irregular gallbladder functioning, are quite serious. 69 while it can be argued that these side effects only persist as long as depo-provera is used, parolees and prisoners are still forced to live with these harsh side effects in order to take a drug that may or may not prevent them from committing another sexual crime. also, while there has been no hard evidence ofdepo-provera causing adverse long-term side effects in humans, studies have shown that depo-provera caused breast cancer in beagles,70 and may cause os­ teoporosis in humans. 71 therefore, it may be unduly harsh to make patients risk potential long-term effects while battling all the short-term side effects to take a drug that may or may not prevent them from committing another sexual of­ fense. the final prong of the test is whether the process is part of an ongoing psychotherapeutic program. it is likely that chemical castration will fail to be considered treatment under this prong. in theory, chemical castration can be used in conjunction with psychotherapy or psychosurgery as an effective treat­ ment process for some mental illnesses.n a problem occurs, however, when an 67. fred s. berlin, the paraphilias and depo-provera: some medical, ethical, and legal considerations, 17 bull. am. acad. psychiairy l. 233, 235-36 (1989). 68. miller, supra note 19, at 183. 69. id. at 182. 70. fitzgerald, supra note 44, at 8. 71. pdr. supra note 31, at 2080. 72. money, supra note 37, at 13. 98 indiana health law review [vol. 5:87 attempt is made to transform theory into a practical treatment regime. so far, as discussed below, no state that allows chemical castration has created a system that effectively links the use ofdepo-provera with psychotherapy; thereby, en­ suring that people who take the drug will actually take it as part of an ongoing psychotherapeutic process. for this reason, chemical castration will likely fail the fourth prong of the test 2. is chemical castration cruel and unusual punishment? assuming that chemical castration would not be considered treatment, the next question is whether it would actually be cruel and unusual to require sex offenders to take depo-provera as a condition of their parole. in order to de­ termine this, the legal standard for what constitutes cruel and unusual punish­ ment must be explored. one potential legal test to determine what is cruel and unusual was outlined by the united states supreme court in the case of fur­ man v. georgia. 73 in that case, the court outlined the potential test as follows: the test, then, will ordinarily be a cumulative one: if a punishment is unusually severe, if there is a strong prob­ ability that it is inflicted arbitrarily, if it is substantially rejected by contemporary society, and if there is no rea­ son to believe that it serves any penal purpose more ef­ fectively than some less severe punishment, then the continued infliction of that punishment violates the command of the clause that the state may not inflict in­ human and uncivilized punishments upon those con­ victed of crimes.74 · therefore, it must be determined where chemical castration falls under each of three prongs: (1) whether the punishment is inherently cruel; (2) whether the punishment is proportional to the crime; and (3) whether the punishment is ex­ cessive in relation to the achievement of legitimate state goals. under the first prong, chemical castration will probably qualify as inher· ently cruel. essentially, inherently cruel punishments are those that are "in­ flicted in wholly arbitrary fashion" or "clearly and totally rejected throughout society."75 therefore, the question is whether stopping a man from being able to have any real sex drive and inflicting an array of side effects is clearly and totally rejected throughout society. it can be argued that the use of chemical castration on sex offenders does meet the standard ofbeing clearly and totally 73. furman v. georgia, 408 u.s. 238, 238 (u.s. 1972). 74. !d. at 282 (brennan, j., concurring) (this opinion was one of a series of concurring opinions in which no more than two judges agreed on this issue. future cases have used this standard and have not been overturned.). 75. /dat28l. 2008] the legaury of chemical castration 99 rejected. as dr. fred berlin stated, "even the mention of castration has an ug­ ly, jarring sound to it. "76 if society as a whole finds the concept offensive when forced on a normal person, then why should someone convicted of a sexual of­ fense be treated as less than an average person? however, given the prevalence of chemical castration programs and statutes, the use of depo-provera injec­ tions on sex offenders is not likely to meet this standard. the next prong is whether chemical castration is proportional to the crime, and the answer is no. when asking whether a punishment is proportional to the crime, it is wise to examine factors such as: how the punishment comports with society's view of decency, whether the punishment is proportional to other seri­ ous crimes, and whether the punishment is consistent with that afforded to simi­ lar crimes in other jurisdictions. 77 first, the concept of chemical castration does not likely comport with society's view of decency, as it involves forcing people to take drugs with many side. effects. it is essentially giving the state control of one's body, which is not considered decent by most of society. second, this punishment is not proportional compared to other serious crimes. most people consider sexual offenses among the worst crimes a person can commit. it is logical to compare the punishment of sexual offenses to the punishment of other horrible crimes such as murder. with murder, drugs are not usually forced on someone unless they are to be given a lethal injection un­ der the death penalty. instead, more time is spent in prison as a way of keeping the person away from society. this does not comport with the goal of chemical castration: get sexual offenders onto the street quicker while at the same time preventing recidivism. while it is true that states have been civilly committing sex offenders to keep them off the streets longer,78 that is counter to the purpose of chemical castration. in fact, the only time drugs are administered as a form of punishment is when a person is judged not guilty by reason of mental defect and then given medication as part of their required treatment in a state mental institution. comparing that situation to chemical castration does provide several simi­ larities. for example, the motive and justification behind both options are fairly similar. the common rationale behind civil commitment and chemical castra­ tion is the protection of the public in a way that prevents sex offenders from being a danger to society. in that context, treatment, as motive, remains a dis­ tant concern. moreover, criminals found not guilty by reason of mental disease or defect, are not per se being punished. instead, because they are unable to comprehend that what they did was wrong such criminals are committed and given treatment in an attempt to help them. conversely, sex offenders are being punished through prison terms and then chemically castrated in an attempt to maintain control over them once they are released. therefore, given the dis76. russell, supra note 25, at 440. 77. fitzgerald, supra note 44, at 38. 78. doubts rise as states hold sex offenders, supra note 2, at a18. 100 indiana iiealrn law review [vol. 5:87 parity of purpose and reasoning between those criminals found guilty by reason of mental disease or defect and those sex offenders who are forced to undergo chemical castration, a comparison actually is inappropriate. next, the question of whether the punishment is consistent to that af­ forded to similar crimes in other jurisdictions needs to be answered. there are several problems with trying to make a comparison among the various state ju­ risdictions that allow chemical castration. first, the way states handle chemical castration varies greatly. some states civilly commit sex offenders they con­ sider dangerous as soon as they are released from prison, and the federal gov­ ernment supports these civil commitments. 79 in fact, president bush recently signed a law offering money to states that commit sex offenders beyond the terms in prison they were assigned by the justice system, and the justice de­ partment is actually creating a program for federal prisoners that will civilly commit some sex offenders. 80 other states take no additional action against sex offenders. trying to compare these different methods to states that use chemi­ cal castration is not a way to determine similarity. it would be like comparing apples and oranges. even if a comparison is made solely among those states that choose chem­ ical castration as a way to handle their sex offenders, problems still exist there is no standard methodology or protocol. as discussed later in this note, the various states that do use chemical castration have different requirements, stan­ dards, and punishment lengths. essentially, how depo-provera is applied and how states determine that the application of chemical castration is warranted is very inconsistent. in some cases, the decision to utilize chemical castration may be very arbitrary and dependent on judges to decide which sex offenders get drugs forced on them and which ones do not this disparity in methods, proto­ cols, and reasoning makes it difficult to have a baseline test for whether the ap­ plication of chemical castration in one state is disproportionate when compared to the application in other jurisdictions. the final prong to examine in answering the question of whether chemical castration is cruel and unusual is whether the punishment is excessive when compared to the state's legitimate interest. chemical castration may actually pass this prong. the state has a legitimate interest in exercising its police pow­ er to protect the public safety. 81 one of the fundamental cornerstones of this power is the protection of children. 82 since certain types of sex offender choose children as their target, 83 the state's interest is increased. given the strong state interest that is present in such instances, chemical castration will probably pass this prong. ultimately, however, chemical castration will likely fail an eighth 79. id. 80. id. 81. nollan v. cal. coastal comm'n, 483 u.s. 825, 837 (1987). 82. sable commc'n v. f.c.c., 492 u.s. 115, 115 (1989). 83. fitzgerald, supra note 44, at 4 (in this instance, the type of sex offenders mentioned is referring to type iv sex offenders, or more specifically pedophiles.) 2008] the legauty of chemical castration 101 amendment challenge because it is unlikely to pass the first or second prongs of the test. 3. the issue of consent another issue that comes up under the eighth amendment is consent. assuming chemical castration is considered treatment, the sex offender must still consent to such treatment before it can be administered, or else it would violate the eighth amendment. 84 in order to have informed consent as required under the eighth amendment, two elements must be satisfied: information and voluntariness. 85 the ftrst element is that of information, which is not met when dealing with chemical castration. in order for this element to be met, all the relevant information must be given to someone before they can consent. whether in­ formation is relevant is based on the following four prongs: the risks, the an­ ticipated benefits, the consequences without treatment, and the alternatives. 86 in general, it is better to err on the side of caution and tell the sex offender all medically relevant facts and potential consequences from using depo-provera. in theory, if the sex offender was told all potential short-term and long-term side effects then this element would be fulfilled and consent could be legally given. in practice, however, none of the state statutes discussed later contain any requirement that a sex offender be informed of the risks and side effects of depo-provera. 87 in addition, ''because all of the long-term side effects ofdepo­ provera treatment are not yet known, there cannot be any true informed con­ sent."8s the other element that must be met for informed consent to be given is that consent must be voluntary. chemical castration with depo-provera, as currently utilized, may not satisfy this element. most statutes require depo­ provera as a condition of parole, which implies that a sex offender may either take depo-provera risking permanent physical alteration or go back to prison.89 when faced with only these choices, is voluntary consent really possible? the supreme court has not made a ftnal ruling on this issue, and different states have come to different conclusions. for example, in maryland the courts have held that prisoners can give adequate consent for experimental or non-medical procedures even if they are in prison. 90 84. bailey v. lally, 481 f.supp. 203, 219 (d.c.md. 1979). 85. jd. at 220. 86. canterburyv. spencer, 464 f2d 772,787-89 (d.c. cir. 1972). 87. see generally part v of this note. 88. druhm, supra note 9, at 306. 89. see generally part v of this note. 90. bailey, 481 f. supp. at 220-21. 102 indiana heal1h law review [vol. 5:87 b. the equal protection claim chemical castration may qualify for an equal protection claim, at which point several problems arise. an equal protection argument is made based on the fourteenth amendment, which states: all persons born or naturalized in the united states, and subject to the jurisdiction thereof, are citizens of the united states and of the state wherein they reside. no state shall make or enforce any law which shall abridge the privileges or immunities of citizens of the united states; nor shall any state deprive any person oflife, lib­ erty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.91 before an equal protection claim can be made, however, it must first be deter­ mined which of the standards of review used in equal protection claims apply. the three standards are: (1) strict scrutiny which requires a compelling gov­ ernmental interest and for the statute to be narrowly tailored, 92 (2) intermediate scrutiny which requires an important governmental interest that is substantially related to the statute,93 and (3) rational basis review which requires a legitimate governmental interest and that there be a reasonably conceivable set of facts· that makes the statute rationally related to that interest. 94 1. the strict scrutiny standard and its requirements chemical castration statutes would not likely satisfy the standard of re­ view for strict scrutiny. the standard of review for strict scrutiny requires a compelling state interest and a narrowly tailored statute.95 first, chemical cas­ tration does likely satisfy a compelling state interest. the state has a compel­ ling interest in the use of its police power to protect its citizens, and given the high recidivism rates among sex offenders, 96 an argument can be made that a compelling state interest is present when chemical castration is employed. most if not all chemical castration statutes will, however, fail to meet thenar­ row tailoring provision of the strict scrutiny standard. to be narrowly tailored the statute must be neither over nor under-inclusive. with regard to chemical castration statutes, there usually exists a problem of over-inclusion. as dis91. u.s. const. amend. xiv§ 1. 92. grutter v. bollinger, 539 u.s. 306, 308 (2003). 93. taun anb nguyen v.i.n.s., 533 u.s. 53, 70(1976). 94. f.c.c. v. beach commc'n, inc., 508 u.s. 307,314-16 (1993). 95. grutter, 539 u.s. at 308. 96. recidmsm for sex offenders, supra note 1, at 11. 2008] the legality of chemical castration 103 cussed in part v of this note, most of the statutes do not differentiate between the various sex offender types and classifications. the statutes allow judges to assign chemical castration as a condition of parole to any sex offender, even though only certain types of sex offenders would benefit from depo-provera injections.97 therefore, most chemical castration statutes in effect force some sex offenders to take depo-provera injections that would neither help them nor make them less likely to commit another sexual offense. for this reason, the chemical castration statutes are usually over-inclusive and would fail an equal protection claim under the strict scrutiny standard. though chemical castration would probably fail under a strict scrutiny standard, there is very little chance it would be argued under such a standard. to qualify for a strict scrutiny standard, there must be either disparate treatment of a suspect class or the infringement of a fundamental right. 98 though sex of­ fenders have been discriminated against and targeted by law enforcement and state governments, they do not qualify as a suspect class. there is also proba­ bly not a fundamental right being infringed upon, so strict scrutiny would not be the correct standard to apply in regards to chemical castration of sex offend­ ers. 2. the intermediate scrutiny argument in regards to chemical castration the standard to be used when examining a statute under intermediate scrutiny is whether there is an important governmental interest involved, and protecting that interest is substantially related to the statute.99 chemical castra­ tion probably passes under the first element, which requires an important gov­ ernmental interest to be at stake. the state does have an important interest in protecting its citizens by exercising its police power, and it can be argued that requiring some sex offenders to take injections ofdepo-provera, to reduce the chance that they will re-offend, falls under that interest. the second element of the intermediate scrutiny standard is that the inter­ est be substantially related to the statute; and chemical castration meets this element. 100 the states that have created chemical castration statutes have all done so with the stated purpose of trying to ensure that sex offenders do not commit another sex offense; thereby, winding up back in prison. clearly, any reduction in sex offender recidivism would be substantially related to a state's interest in the protection of its citizens. however, the use of chemical castra­ tion in many of the states is rather indiscriminate, and depo-provera is forcibly given to people for whom the drug will not be helpful. the general rule is that "mp a should only be prescribed for those offenders to whom it offers the 97. only type iv sex offenders would find depo-provera injections helpful in preventing future crimes and treating their problem. see fitzgerald, supra note 44, at 4. 98. johnson v. california, 543 u.s. 499, 505 (1945). 99. taun anh nguyen, 533 u.s. at 70. 100. id. 104 indiana health law review [vol. 5:87 promise ofhope. otherwise, mp a is an inappropriate or ineffective treatment ••• " 101 therefore, most state statutes that deal with the chemical castration of sex offenders would probably survive an equal protection challenge under in­ termediate scrutiny. there may, however, be one valid argument that chemical castration stat­ utes fall under intermediate scrutiny. indeed, one classification that warrants intermediate scrutiny are statutes that discriminate based on gender. in the case of using depo-provera injections on sex offenders, there is a strong argument that the use of depo-provera in this manner discriminates based on gender. depo-provera is given to sex offenders so that their sex drives will be reduced. the purpose for which depo-provera is given to sex offenders, the reduction of their sex drives, is usually effective only when the drug is given to males. 102 when depo-provera is given to females, it is usually prescribed for birth con­ trol.103 the effect ofdepo-provera on the female sex drive has not been stud­ ied and is currently unknown. there is evidence, however, that depo-provera does reduce the ability of men to sustain erections and does reduce their sexual drive.104 therefore, when depo-provera is administered to sex offenders, it is being administered primarily, if not entirely to men. thus, the chemical castra­ tion statutes discriminate along gender lines. gender discrimination, however, does not automatically imply that chemical castration will fail an equal protec­ tion challenge. the supreme court has held that "the equal protection clause does not mean that the physiological differences between men and women must be disregarded .... the constitution surely does not require a state to pretend that the demonstrable differences between men and women do not exist"105 therefore, most hypothetical and real chemical castration statutes would likely survive an equal protection challenge under the intermediate scrutiny standard of review. 3. rational basis review: its result when applied to chemical castration an equal protection challenge to chemical castration statutes would most likely fall under the rational basis standard of review. chemical castration stat­ utes are discriminatory, in that they separate some male sex offenders, in terms of a possible sentence and punishment, from both other male sex offenders and from non-sex crime offenders. based on this disparate treatment, an equal pro­ tection claim could be brought against chemical castration statutes under a ra­ tional basis review. to survive rational basis review, a statute must advance a legitimate gov­ ernmental interest and there must be some reasonably conceivable set of facts 101. fitzgerald, supra note 44, at 59. i 02. money, supra note 37, at 220. 103. pdr, supra note 31, at 2080. 104. money, supra note 37, at 220. 105. michael m. v. super. ct., 450 u.s. 464,481 (1981). 2008] the legauty of chemical castration 105 that makes the statute rationally related to that interest 106 chemical castration statutes would almost definitely pass a challenge under this standard. courts rarely overturn a statute based on rational basis review, as in almost any situa­ tion a legitimate governmental interest can be found and some reasonably con­ ceivable facts could be hypothesized that rationally relate the statute to the interest. the state can argue that it has a legitimate interest in protecting its citizens from sex offenders, and administering depo-provera injections to re­ duce the sex drive of sex offenders rather than non-sex offenders is rationally related to that interest. therefore, it is almost certain that any hypothetical or real chemical castration statute would survive an equal protection challenge if rational basis is the standard of review used by the court. though most chemical castration statutes would not survive a strict scru­ tiny standard, it is exceedingly unlikely that the strict scrutiny standard would be applied. instead, either intermediate scrutiny at best or rational basis review at worst would be the standard a court uses to judge the equal protection claim. under both of those standards, however, most hypothetical or real chemical castration statutes would pass. consequently, because chemical castration stat­ utes would likely survive an attack under both the intermediate and rational basis standards of review, an equal protection challenge will probably fail. c. the problem of double jeopardy another constitutional issue that arises from the use ofdepo-provera on sex offenders is the concept of double jeopardy. this concept is based on the fifth amendment, which states: no person shall be held to answer for a capital, or oth­ erwise infamous crime, unless on a presentment or in­ dictment of a grand jury, except in cases arising in the land or naval forces, or in the militia, when in actual ser­ vice in time ofw ar or public danger; nor shall any per­ son be subject for the same ojfonce to be twice put in jeopardy of life or limb; nor shall be compelled in any criminal case to be a witness against himself, nor be de­ prived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation.107 essentially, double jeopardy means that a person cannot be tried or pun­ ished for the same crime twice. double jeopardy protections might attach to ''a second prosecution for the same offense after acquittal; a second prosecution 106. beach commc'n, 508 u.s. at 314-316. 107. u.s. const. amend. v (emphasis added). 106 indiana health law review [vol. 5:87 for the same offense after conviction; and multiple punishments for the same offense. "108 the u.s. supreme court has held that the concept of double jeop­ ardy applies to both being convicted for the same crime twice and being pun­ ished for the same crime twice.109 an argument can be made that chemical castration violates double jeopardy. as discussed in part v of this note, infra, several states require parolees to take depo-provera until the department of corrections in that state decides it is no longer necessary.110 there is a very real possibility in these states that a sex offender could be required to receive depo­ provera injections beyond their parole. if that possibility materialized, the pun­ ishment as implemented would actually extend beyond the term of the original punishment sentenced (time incarcerated and time on parole). it could, there­ fore, be argued that requiring depo-provera treatments, as a condition of parole that extends beyond the time a sex offender is on parole, would result in the court issuing two punishments for the same crime; thereby, violating the fifth amendment this is especially true if the sex offender was tried and convicted of his crime before the state adopted its chemical castration statute. con­ versely, if the sex offender was convicted after the state statute was enacted, it could be argued that the original punishment included a chemical castration parole condition and does not, therefore, violate double jeopardy protections. v. current state statutes and their inherent flaws a. california's chemical castration statute in 1996, california amended its criminal statutes through assembly bill 3339 to add chemical castration as a possible punishment or parole requirement for sex offenders.m the bill, which was passed and became a law, states in pertinent part: (a) any person guilty of a first conviction of any offense specified in subdivision (c), where the victim has not at­ tained 13 years of age, may, upon parole, undergo me­ droxyprogestrone acetate treatment or its chemical equivalent, in addition to any other punishment pre­ scribed for that offense or any other provision of law, at the discretion of the court (b) any person guilty of a second conviction of any of­ fense in subdivision (c), where the victim has not at108. united states v. halper, 490 u.s. 435,440 (1989). 109. abney v. united states, 431 u.s. 651, 660 (1977). 110. see infra part v. none of the state statutes discussed later establish a definite tennination date for the depo-provera treatment 111. henderson, supra note 27, at 653. 2008] the legality of chemical castration tained 13 years of age, shall, upon parole, undergo me­ droxyprogestrone acetate treatment or its chemical equivalent, in addition to any other punishment pre­ scribed for that offense or any other provision of law .... (d) the parolee shall begin medroxyprogesterone acetate treatment one week prior to his or her release from con­ finement in the state prison or other institution and shall continue treatments until the department of corrections demonstrates to the board of prison terms that this treatment is no longer necessary. (e) if a person voluntarily undergoes a permanent, surgi­ cal alternative to hormonal chemical treatment for sex offenders, he or she shall not be subject to this sec­ tion.112 107 this statute, hailed by many in california as a possible solution for the problems created by sex offenders generally, is plagued by several serious flaws that render it both problematic and constitutionally suspect. first, the statute does not require any medical expert's input or diagnosis of the sex offender.113 thus, judges must act as a medical doctor ("md'') and determine for themselves whether depo-provera would be useful. however, this inquiry applies only to first offenses. according to this statute, second-time offenders against children under the age of thirteen shall automatically receive chemical castration as a condition of parole without any medical considera­ tions.114 also, since there is no requirement that a judge listen to a doctor, the judge can actually overrule a consulting physician since the statute relies heav­ ily on judicial discretion.115 this shortcoming was best illustrated in the case of state v. estes. 116 though this case does not come from california, it deals with the same underlying problem ofuncheckedjudicial discretion and arbitration with regard to medical and/or psychiatric determinations. in estes, a man kidnapped a young boy and pled to first degree kidnap­ ping.117 the doctor who examined the defendant believed the man to be ape­ dophile and recommended that he be put on depo-provera.118 however, the judge held that "even though estes may be treatable with the aid of depo­ provera under the right conditions and circumstances, there is no guarantee of success and in reality, the odds are against it."119 the judge "placed the great­ est emphasis on the need to protect society'' and proceeded to overrule the opin112. cal. penal code§ 645 (1998). 113. id. 114. !d. 115. id. 116. state v. estes, 821 p.2d 1008,1009 (idaho ct. app. 1991). 117. id. 118. id. 119. idat 1009-10. 108 indiana heal1h law review [vol. 5:87 ion of the medical expert and gave the man a lengthy prison sentence. 120 in this example, a medical expert was ignored and a judge decided his knowledge of how to handle potential sex offenders was greater than medical experts, a deci­ sion that helped to show that relying on ordinary people with no medical exper­ tise to make medically complicated decisions merely opens the door for misuse and poor decisions. second, the statute never requires a determination of what type of sex of­ fender has been charged and convicted and whether they would actually be helped by depo-provera. 121 therefore, the parolees may be required to take depo-provera even if it will not affect his desire or potential to commit another crime. under this statute, type i, ll, and m sex offenders could be forced to take a drug with a long list of harmful side effects that will in no way deter or affect their potential to commit another sexual offense.122 thus, california may be forcing drugs into a person's body for no real reason. third, this statute does not require or even suggest the use of psychologi­ cal therapy to be used in conjunction with the drug.123 since neither a judge nor the statute can force a parolee to attend therapy, this statute severally limits depo-provera' s effectiveness, if any, to prevent recidivism among parolee.124 this means that parolees, likely to benefit from therapy, are released despite the fact that the absence of therapy increases the risk of recidivism. fourth, this statute is flawed in that it fails to establish limits on the dura­ tion ofdepo-provera treatments. the statute does provide that treatments shall continue ''until the department of corrections demonstrates to the board of prison terms that this treatment is no longer necessary."125 however, it estab­ lishes no terms or conditions upon which the board of prison terms can base its determination. also, charging the department ofconections with the job of persuasion could violate our adversarialjustice system's underlying principle, that people face an unbiased judge with an advocate on their side before being punished. the department of corrections, which is responsible for the sex of­ fender, has an incentive to be very conservative and keep parolees on the drug as long as possible. since the department of corrections and the board of prison terms share the same responsibility and interest, they are not going to be as zealous as they should be in trying to get parolees off of depo-provera. thus, instead of making it solely a department of corrections' duty, there 120. /d. 121. the opinion of a medical expert could greatly assist the court in making this determi­ nation. given that a determination of sex offender type must be made, it is only logical that medical experts should be required to participate. 122. fitzgerald, supra note 44, at 1. 123. jennifer m. bund, comment, did you say chemical castration?, 59 u. pm. l. rev. 157, 157 (1997) (this flaw has already been pointed out). 124. recidmsm for sex offenders, supra note i, at 11 (this article contains a study showing substantially lower recidivism rates among sex offenders who underwent therapy as compared to sex offenders who received no treatment at all.). 125. cal. penal code§ 645 (1998). 2008] the legauty of chemical castration 109 should be a mechanism through which a parolee can independently or by coun­ sel petition the board of prison terms to terminate depo-provera treatments. it is also unclear how long the department of corrections can require the sex offender to take depo-provera. 126 what happens when the parole period for the sex offender ends? it is not stated exactly how long the department of cor­ rections can require sex offenders to take depo-provera injections. for exam­ ple, can the department of corrections decide that the sex offender is still a danger to others and require him to continue to take depo-provera injections beyond his parole? if so, then double jeopardy rights may be implicated be­ cause the criminal justice system is essentially punishing the sex offender be­ yond the original prison term he was given.127 fifth, another flaw present in the california statute involves the provision relating to the weekly injection ofdepo-provera. the statute requires certain sex offenders be given weekly injections, 128 but the mechanism and method of providing those injections is not outlined.129 exactly where, when, and how these injections are to be administered to those sex offenders requiring depo­ provera as a condition of parole is unclear. is the offender supposed to find a facility himself, or will the department of corrections handle it? is the of­ fender to pay for the injections himself, or will the department of corrections and the taxpayers pay for the injections ofdepo-provera? who decides which physician administers the injections? these questions are left unanswered by california's statute. finally, the california statute runs afoul of the consent element of the eighth amendment. as discussed in part n.a.3, in order for consent to be given, it must be voluntary. this statute, however, essentially gives a sex of­ fender three "choices." he can either accept taking depo-provera and brave the long list of side-effects, remain in prison for the remainder of his sentence, or undergo a permanent invasive surgical castration. b. montana's chemical castration statute montana enacted its chemical castration statute on april19, 1997, and the statute resembles california's original statute.130 the statute states: (1) a person convicted of a first offense under 45-5503(3), 45-5-503(3), or 45-5-507{4) may, in addition to the sentence imposed under those sections, be sentenced 126. dmhm, supra note 9, at 339-40 (the question ofhow long a sex offender can be required to take depo-provera injections was explored in this comment.). 127. see .discussion supra part iv.c. 128. cal. penal code§ 645 (1998). 129. dmhm, supra note 9, at 340 (the lack of guidelines for providing the depo­ provera injections was examined in this comment). 130. montana adopts chemical castration, s.d. union-trmute, apr. 27, 1997, at alo. 110 indiana health law review to undergo medically safe medroxyprogesterone acetate treatment or its chemical equivalent or other medically safe drug treatment that reduces sexual fantasies, sex drive, or both, administered by the department of correc­ tions or its agent pursuant to subsection (4). (2) a person convicted of a second or subsequent of­ fense under 45-5-502(3), 45-5-503(3), or 45-5-507(4) may, in addition to the sentence imposed under those sections, be sentenced to undergo medially safe me­ droxyprogesterone acetate treatment or its chemical equivalent or other medically safe drug treatment that reduces sexual fantasies, sex drive, or both, administered by the department of corrections or its agent pursuant to subsection (4). (3) a person convicted of a ftrst or subsequent offense under 45-5-502, 45-5-503, or 45-5-507 who is not sen­ tenced to medically safe medroxyprogesterone acetate treatment or its chemical equivalent or other medically safe drug treatment that reduces sexual fantasies, sex drive, or both, may voluntarily undergo such treatment, which must be administered by the department of correc­ tions or its agent and paid for by the department of cor­ rections. ( 4) treatment under subsection (1) or (2) must begin one week before release from confmement and must con­ tinue until the department of corrections determines that the treatment is no longer necessary. failure to continue treatment as ordered by the department of corrections constitutes a criminal contempt of court for failure to comply with the sentence, for which the sentencing court shall impose a term of incarceration without possibility of parole of not less than 10 years and not more than 100 years. 131 [vol. 5:87 this statute is superior to california's statute in that it does not include a man­ datory provision for the administration of depo-provera to sex offenders; m however, it also shares several of the california statute's weaknesses and has created one of its own. montana's statute, while not mandating depo-provera treatments, vests the court with discretion to impose depo-provera treatments as part of the sen131. mont. code ann. § 45-5-512(1)-(4) (1998). 132. cal. penal code§ 645 (1998) (california's statute mandates drug treatment only for repeat offenders.). 2008] the legauty of chemical castration 111 tence and not merely as a parole condition.133 thus, under the montana statute, the original trial judge could determine on a first offense that a sex offender would have to take depo-provera injections as part of his initial punishment. since failure to follow the requirement can result in a minimum of an additional decade in prison, the judge can almost impose an additional punishment or a punishment that reverberates beyond his time in prison where a person pays his debt to society. such an option may be considered cruel and unusual punish­ ment under the eighth amendment. the montana statute also has a familiar shortcoming in that it does notre­ quire, at either the trial or parole stage, input from medical experts.134 this means that a person can be medically diagnosed as a sex offender by a lay per­ son such as a judge who lacks medical expertise and who is not subject to the hippocratic oath. to allow a judge to essentially diagnose and order treatment with no medical expertise allows for very arbitrary decisions and thus could qualify as cruel and unusual punishment. also, this determination would be a heavy burden to place on a judge's shoulders and opens the door for a series of forced treatments on prisoners and parolees who should not be required to take depo-provera. another common problem facing montana's chemical castration statute is the lack of time limits on mandatory depo-provera treatments. like california, montana's statute sets no termination date for the depo-provera injections.135 instead, the sex offender is required to take the depo-provera injections ''until the department of corrections determines the treatment is no longer neces­ sary. "136 the statute provides no details for how the department of corrections is to make its determination, nor explains whether the sex offender can petition to terminate the depo-provera injections. since a sex offender who fails to continue mandatory depo-provera faces ten to one hundred years in jail without the possibility of parole, 137 the sex offender could decide not to risk that pun­ ishment and simply continue to take depo-provera instead of fighting to end the injections. the statute also fails to recognize the distinct types of sex offender.138 the four types of sex offender have very subtle, nuanced differences that trained psychologists and psychiatrists are better able to detect than judges. like the california statute, under the montana statute, a non-expert judge may be forcing some sex offenders to take a drug with significant side effects but no beneficial effects on their propensity to commit sex crimes. moreover, it also opens the door for granting parole to type i, ll, and ill sex offenders under the 133. mont. code ann.§ 45-5-512(1)-(4)(1998). 134. druhm, supra note 9, at 340 (this comment highlighted this issue in california's chemical castration statute, but the same problem exists with montana's statute.). 135. mont. code ann.§ 45-5-512 (1998). 136. id. 137. id. 138. mont. code ann.§ 45-5-512 (1998). 112 ~mnah~thlawrevffiw [vol. 5:87 · mistaken assumption that depo-provera would diminish the likelihood that they will commit another sex crime. c. florida's chemical castration statute florida's chemical castration statute was adopted on may 30, 1997139 and designed to go into effect on october 1, 1997.140 this statute shares many flaws that seem common to most legislatures' efforts to legalize chemical cas­ tration. in pertinent part the statute states: (1) notwithstanding any other law, the court: (a) may sentence a defendant to be treated with me­ droxyprogesterone acetate (mpa), according to a sched­ ule of administration monitored by the department of corrections, if the defendant is convicted of sexual bat­ tery as described in s. 794.011. (b) shall sentence a defendant to be treated with me­ droxyprogesterone acetate (mp a), according to a sched­ ule of administration monitored by the department of corrections, if the defendant is convicted of sexual bat­ tery as described ins. 794.011 and the defendant has a prior conviction of sexual battery under s. 794.011. if the court sentences a defendant to be treated with me­ droxyprogesterone acetate (mpa), the penalty may not be imposed in lieu of, or reduce, any other penalty pre­ scribed under s. 794.011. however, in lieu of treatment with medroxyprogesterone acetate (mp a), the court may order the defendant to undergo physical castration upon written motion by defendant providing the defendant's intelligent, knowing, and voluntary consent to physical castration as an alternative penalty. (2)(a) an order of the court sentencing a defendant to medroxyprogesterone acetate (mpa) treatment under subsection (1 ), shall be contingent upon a determination by a court appointed medical expert, that the defendant is an appropriate candidate for treatment. such determi­ nation is to be made not later than 60 days from the im­ position of sentence. notwithstanding the statutory maximum periods of incarceration as provided in s. 7 55.082, an order of the court sentencing a defendant to medroxyprogesterone acetate (mpa) treatment shall 139. 1997 fla. sess. law serv. ch. 97-184 (west). 140. fla. stat. ann. § 794.0235 (west 2006). 2008] the legality of chemical castration specify the duration of treatment for a specific term of years, or in the discretion of the court, up to the life of the defendant (b) in all cases involving defendants sentenced to ape­ riod of incarceration, the administration of treatment with medroxyprogesterone acetate (mpa) shall com­ mence not later than one week prior to defendant's re­ lease from prison or other institution.141 113 this statute, like the statutes found in california and montana, relies heavily on judicial discretion. the judge determines ifdepo-provera is given to a person convicted of a first offense.142 on conviction of a second offense, chemical castration becomes mandatory.143 however, there is one difference: section two requires a medical expert to verify that the sex offender could benefit from depo-provera, and that the drug would actually be effective.144 this is an im­ portant difference, as it provides a better system of checks and balances. the statute, however, still has major flaws. perhaps the most important flaw in the florida statute is its failure to pro­ vide for the termination of treatment. unlike statutes in montana and califor­ nia, florida's statute does not provide anyway for a person to petition the court or other agencies to end the treatments. the statute simply asks a medical ex­ pert to verify that the person could benefit from depo-provera. after such veri­ fication a judge could, in theory, sentence a person to a lifetime of drug treatments. with no way to stop the drug injections, the defendant could essen­ tially be punished for life beyond the initial prison sentence. in addition, the sex offender may have to take the drugs even though severe side effects result. if a defendant experiences severe side effects or even an allergic reaction, the statute does not provide an opportunity for the offender to cease the injections. this means he would be forced to either continue taking something that seri­ ously affects his health or face punishment for violating the court's proscribed treatment plan. another flaw inherent in the florida statute is that the statute does not provide any form of punishment or response if a person takes other drugs. there are some drugs, such as steroids or possibly viagra that can counteract the affects ofdepo-provera.145 in theory, a person could take such drugs effec­ tively nullifying the impact of chemical castration.146 thus, this statute does not 141. id. 142. fla. stat. ann. § 794.0235(1xa) (west 2006). 143. fla. stat. ann. § 794.0235(l)(b) (west 2006). 144. fla. stat. ann. § 794.0235(2xa) (west 2006). 145. john litchfield, sarkozy acts after paedophile is given viagra, tim independent (eur.) (aug. 2007), http://news.independent.co.ukleuropelarticle2881406.ece (last visited apr. 9, 2008). 146. id. 114 indiana health law review [vol. 5:87 provide any form of counter measure or enhanced punishment for people who take other drugs to render judge ordered chemical castration ineffective. finally, the statute may have constitutional problems with regard to the is­ sue of consent. under section 1 (c), a person can choose surgical castration over chemical castration as a form of treatment 147 however, there is still a question of whether a person can knowingly volunteer when the options are prison, mind-altering drugs, or invasive surgery. it is possible that this statute could survive such a challenge, given that the statute specifically states it must be a knowing and voluntary request; but given that people facing this statute have no other viable choices, it may still be argued that one can never knowingly or vol­ untarily consent to chemical castration. d. louisiana's chemical castration statute louisiana's chemical castration statute is very different from statutes in other states. louisiana has removed several of the problems inherent in the statutes of other states. louisiana's efforts, however, are still problematic. the applicable sections of the statute state: c.(l)(a) no sexual offender, whose offense involved a minor child who is twelve years old or younger; or (b) who is convicted two or more times of a violation of r.s. 14:42,42.1, 43, 43.1, 43.2, 43.3, 43.4, 78, 78.1, or 89.1 shall be eligible for probation, parole, or suspension of sentence or diminution of sentence if imposed as a condition by the sentencing court pursuant to. r.s. 15:537(a), unless, as a condition thereof, the offender undergoes a treatment plan based upon a mental health evaluation which plan shall effectively deter recidivist sexual offenses by the offender, thereby reducing risk of reincarceration of the offender and increasing safety of the public, and under which the offender may reenter so­ ciety. serial sexual offenders sentenced pursuant to r.s. 15:537(b) shall not be eligible for parole, probation, or suspension of sentence. (2)( a) 'mental health evaluation', as used in this subsec­ tion, means an examination by a qualified mental health professional with experience in treating sexual offend­ ers. (b) the treatment plan may include: 147. fla. stat. ann. § 794.0235(1xc) (west 2006). 2008] the legality of chemical castration (i) the utilization ofmedroxyprogesterone acetate treat­ ment or its chemical equivalent as a preferred method of treatment. (ii) a component of defined behavioral intervention if the evaluating qualified mental health professional de­ termines that is appropriate for the offender. (3)(a) the provisions of this subsection shall only apply if parole, probation, or suspension or diminution of sen­ tence is permitted by law and the offender is otherwise eligible. (b) if on probation or subject to a sentence that has been suspended, the offender shall begin medroxyprogester­ one acetate or chemically equivalent treatment as or­ dered by the court or a qualified mental health professional and medical staff. (c) if medroxyprogesterone acetate or chemically equiva­ lent treatment is part of an incarcerated offender's treat­ ment plan, the offender shall begin such treatment six weeks prior to release. (d) the offender shall continue treatments during incar­ ceration and any suspended sentence, probation, or pa­ role, unless it is determined that the treatment is no longer necessary. (4) before beginning medroxyprogesterone acetate or chemical equivalent therapy as required by the provi­ sions of this subsection, the offender shall be informed about the uses and side effects of medroxyprogesterone therapy, and provide the department with a written ac­ knowledgment that he has received this information. (5) the offender shall be responsible for the costs of the evaluation, the treatment plan, and the treatment. (6)(a) chemical treatment pursuant to this subsection shall be administered by the state through a licensed medical practitioner. (b) any physician or qualified mental health profes­ sional who acts in good faith in compliance with this subsection in the administration of treatment shall be immune from civil or criminal liability for his actions in connection with such treatment. (7) failure to continue or complete treatment pursuant to this subsection shall be a ground for revocation of pro­ bation, parole, or suspension of sentence. good time earned may be forfeited pursuant to r.s. 15:571.4. (8) if an offender voluntarily undergoes a permanent, surgical alternative to hormonal chemical treatment for 115 116 indiana health law review sex offenders, he shall not be subject to the provisions of this subsection. (9) the department of public safety and corrections shall promulgate rules and regulations to implement the provisions of this subsection.148 [vol. 5:87 clearly, this statute does significantly improve upon the chemical castrations statutes of california and florida in one way. unlike the laws in california or florida that rely heavily on judicial discretion, louisiana's statute relies more on medical experts. in the louisiana statute, depo-provera injections are only required when they are part of a treatment program designed and recommended by a "qualified mental health professional [who has] experience interacting with sexual offenders."149 this provision should keep the state from giving depo-provera injections to those sex offenders that will not be helped, and will help target which sex offenders could benefit from depo-provera injections more effectively than relying on judicial discretion. though this statute is an improvement, it still has several flaws. perhaps the most significant flaw in this statute is related to funding for depo-provera treatment and any other treatment(s) required by this statute. according to this statute, the sex offender is required to pay the costs of the evaluation, the treat­ ment, and the treatment plan.150 the statue also requires the sex offender to begin depo-provera injections six weeks before release.151 there are several problems with these requirements. first, it is unlikely that most sex offenders requiring depo-provera injec. tions are capable of paying for the treatment, as the injections cost hundreds of dollars a month.152 according to the statute, a sex offender must find a way to pay for the frrst six weeks ofdepo-provera treatment while he is still incarcer­ ated in addition to paying for the treatments once released. when a sex of­ fender is released he will likely have difficulty finding a job given he are an ex­ convict with a sex offense on his record. his prior sexual offense and criminal record severely limits his job pool, since his job must not be within one thou­ sand feet of a secondary or elementary school, day care, playground, private or public youth facility, public swimming pool, or free-standing video arcade fa­ cility or he violates his parole and is sent back to prison.153 it could take con­ siderable time for a sex offender to locate a job, and yet he still must pay for his treatment and injections. these facts indicate that a large and potentially in­ surmountable financial burden is placed on the sex offender by this statute. indeed, if a sex offender does not find a way to pay for depo-provera injections 148. la. rev. stat. ann. § 15:538(cx1)-(9) (1998). 149. la. rev. stat. ann. § 15:538(cx2)(a) (1998). 150. la. rev. stat. ann. § l5:538(c)(5) (1998). 151. la. rev. stat. ann.§ 15:538(cx3xc) (1998). 152. dispute on therapy benefits, supra note 43, at a18. 153. la. rev. stat. ann.§ 15:538(dxi)(a-c)(i998). 2008] the legality of chemical castration 117 and other treatment(s) ordered by the medical expert, he will be sent back to prison. given this burden, it is likely that many sex offenders who could qual­ ify and receive the help they need would be unable to pay for such treatment and consequently be stuck in prison. this burden seems to run counter to the purpose of the statute, which is to get sex offenders out of the over-crowded prison while reducing their chances of recidivism. the second problem with requiring a sex offender to pay for his own de­ po-provera injections and treatment is the determination of when the treatment ends. according to the statute, the sex offender must continue to take depo­ provera injections and pay for his treatment until "it is determined the treatment is no longer necessary.''154 this essentially means that the sex offender has the cost of the depo-provera injections and treatment assigned to him by the judi­ cial system, and then must pay for the treatment until the department of correc­ tions determines the treatment is no longer necessary. this is the equivalent of sending someone to prison and then charging them rent in addition, there is nothing in the statute that indicates that depo-provera and any other assigned treatment can end once the parole period for the sex offender is over. the sex offender could be forced to continue treatment beyond his parole period, and if the department of corrections never decides that the treatment is no longer nec­ essary, the sex offender would then be saddled with a financial burden for the rest of his life. this could be considered cruel and unusual punishment. e. oregon's chemical castration statute oregon first developed a chemical castration program for sex offenders on july 1, 1999, when a pilot program was ordered by governor john a. kitz­ haber. 155 eventually, a statute was written to deal with sex offenders. in ore­ gon, a sex offender is defmed as a person who: (a) has been convicted of a sex crime; (b) has been found guilty except for insanity of a sex crime; (c) has been found to be within the jurisdiction of the juvenile court for having committed an act that if com­ mitted by an adult would constitute a sex crime; or (d) is paroled in oregon under ors 144.610 after being convicted in another jurisdiction of a crime that would constitute a sex crime if committed in ... [oregon ].156 154. la. rev. stat. ann.§ 15:538(cx3xd) (1998). 155. caroline m. wong, comment, chemical castration: oregon's innovative ap­ proach to sex offender rehabilitation or unconstitutional punishment?, 80 or. l. rev. 267,274 (2001). 156. or. rev. stat. 181.594(5xa)-(d) (1999). 118 indiana health law review [vol. 5:87 with regard to the issue of the chemical castration of sex offenders, statute 144.625 states in pertinent part: (1) the department of corrections shall establish a pilot treatment program for persons convicted of sex crimes who are eligible for parole or post-prison supervision. the purpose of the program is to reduce the risk of reof­ fending after release on parole or post-prison supervision by providing, each year, 40 to 50 persons convicted of sex crimes with hormone or antiandrogen, such as me­ droxyprogesterone acetate, treatment. (2) under the program the department shall: (a) screen persons convicted of sex crimes who are eli­ gible for release within six months on parole or post­ prison supervision to determine their suitability for hor­ mone or antiandrogen treatment upon release; (b) refer persons found most likely to benefit from hor­ mone or antiandrogen treatment to a competent physi­ cian for medical evaluation; and (c) refer those persons, unless medically contraindicated after the evaluation by a competent physician, to a com­ munity physician to begin hormone or antiandrogen treatment upon their release on parole or post-prison su­ pervision. (3) the state board of parole and post-prison supervi­ sion shall require as a condition of parole or post-prison supervision hormone or antiandrogen treatment during all or a portion of parole or post-prison supervision of persons required to participate in the hormone or antian­ drogen treatment program described in subsection (2) of this section. ( 4) a person required to undergo a treatment program under subsection (2) of this section violates a condition of parole or post-prison supervision and is subject to sanctions if the person: (a) fails to cooperate in the treatment program required under subsection (2) of this section; or (b) takes any steroid or other chemical to counteract the treatment required under subsection (2) of this section.157 though only a pilot program, this is a very well thought out statute. it relies not on judicial discretion, but rather on a competent medical diagnosis and deter157. or. r.ev. stat. 144.625 (1999). 2008] the legality of chemical castration 119 mination that the candidate would benefit from depo-provera. also, the statute provides a response should the offender seek to counter depo-provera' s effects with other drugs. there are, however, two flaws remaining in this statute that create problems. first, chemical castration can terminate only after a negative evaluation by a competent physician. the evaluation must state that the treatment is either no longer effective, or that it is damaging to the offender. 158 moreover, under the oregon statute, the prisoner cannot refuse to be part of the pilot program, and unlike statutes in other states, oregon provides no alternative option for the prisoner.159 consequently, unlike his peers in other states, a sex offender in oregon cannot choose pennanent physical castration over drug therapy. thus, in oregon, a prisoner either takes the drugs as ordered, or violates parole and returns to prison. 160 second, there is an important time gap in this pilot program. depo­ provera takes about a week for the effectiveness ofthe cycle to begin. 161 other states require prisoners to begin treatment one week prior to parole. oregon, however, gives sex offenders their first treatment after release. 162 this means for the frrst week of parole the parolee has his normal sex drive, and may have a motivation to commit a sexual crime. after all, once that one week is up, his hormones will be suppressed and his sex drive greatly diminished. thus, this week gap represents a last chance to experience normal sexually activity. an­ other advantage of having a prisoner begin dosages of depo-provera before parole is that the department of corrections can monitor him during that week. they can check to see if the dosage levels are sufficient and watch for any allergic or negative reactions to the drug. in oregon, none of that occurs, so the prisoner is released with the hope that the drug will be of sufficient dosage to have some effect, and under the assumption that the former prisoner will not be allergic to or suffer debilitating side effects from the drug. f. overall problems with the chemical castration statutes now in effect as outlined above, there are no current statutes that have any chance of being both effective and constitutional. in general, however, the statutes can be divided into two major categories based on who determines when depo­ provera applies. some of the states, such as california and montana, rely on judicial discretion, and do not require medical experts to weigh in on the ad­ ministration ofdepo-provera injections to sex offenders. 163 these same states 158. /d. 159. /d. 160. /d. 161. john money, love and love sickness: the science of sex, gender difference and pair-bonding 205-207 (1980), http://www.heretical.com/money /soffence.html (last visited mar. 15, 2008). 162. or. rev. stat. 144.625(2)(c) (1999). 163. druhm, supra note 9, at 285 (this flaw is first discussed in relation to california's 120 indiana healm law review [vol. 5:87 also provide little direction for judges when deciding what types of sex offend­ ers will benefit from depo-provera.164 with no medical input or diagnosis, these statutes fail to adequately handle the use ofdepo-provera; a second type of statute that seems prevalent is one where the medical community is involved in the original determination of whether a sex offender should receive the depo-provera injections. states such as oregon and louisi­ ana address the problem of potentially poor identification, of those sex offend­ ers that would benefit from depo-provera, by requiring medical diagnosis. however, in these states and statutes, there are flaws with regard to the actual implementation ofdepo-provera injections. these flaws range from financial issues, as in louisiana where offenders must pay for their own treatment, 165 to release issues, as in oregon where offenders do not start treatment until they are released.166 basically then, all state statutes regarding the use of chemical cas­ tration are imperfect. indeed, no state has yet managed to enact a chemical cas­ tration statute that is both effective and permissible under the constitution. g. europe's approach to chemical castration unlike the united states which has only recently enacted chemical castra­ tion statutes, several european countries have had castration statutes on the books for quite some time. denmark was the first country to create a castration law in 1929.167 sweden passed a castration law in 1944,168 finland passed a law in 1970,169 and norway enacted its castration law in 1977.170 these euro­ pean statutes are somewhat different from american efforts, in part because the european drafters have greater leeway in drafting their statutes because they are not bound by the united states constitution and bill of rights. the european statutes do, however, provide some insight into the effective design of sex of­ fender statutes . . for example, some the european statutes have a minimum age require­ ment that must be met before castration becomes an option.171 in the united states, age is considered a mitigating factor in several areas of law, ranging from consent to ability to understand. in addition, many states in america have strict statutory rape statutes that define when a sex crime has occurred. there­ fore, american states wishing to require the castration of sex offenders should statute, but it is an applicable flaw here.). 164. see generally henderson, supra note 27, at 653 (this note concludes that only certain types of sex offenders can benefit from chemical castration and points out that the california statute does not resolve this issue.). 165. see discussion supra part iv( d) (discussing the flaw of forcing sex offenders to pay for their own treatment). 166. seediscussionsuprapartiv(e)(notingthattheeffectsofdepo-proverawouldn'tstart until a week after a sex offender bas received his first injection). 167. lemaire, supra note 10, at 294. 168. svensk f6rfattningssamling, 45 int'l dig. heal111 legis. 324, 324 (1994). 169. suomen asetuskokoelma, 211nt'ldig. heal111legis. 705,705 (1970). 170. norsk lovtidend, 30 int'l dig. heal111 legis. 118, 118 (1979). 171. russell, supra note 25, at 442. 2008] the legauty of chemical castration 121 mirror their european counterparts and adopt a minimum age requirement for the implementation of chemical or physical castration procedures. the exact age of enforcement could be anywhere from fourteen to twenty-one years of age, as long as there is some understanding that a juvenile sex offender younger than a certain age should not be forced to choose between taking a mind­ altering medication or facing a longer prison sentence. another important factor that distinguishes european sex offender statutes from their american counterparts is that many european statutes place greater emphasis on medical expert testimony and diagnosis; rather, than relying pri­ marily on judicial discretion. several european statutes require a neutral medi­ cal expert board to make a determination on whether the sex offender would even benefit from castration before it is considered as an option. given that a majority of american judges have no medical background or experience, the european reliance on medical experts should also be considered by american legislatures when drafting sex offender statutes. indeed, an increased reliance on the judgment of medical practitioners could only enhance the efficacy and constitutionality of american sex offender statutes. vi. conclusion castration has been a form of punishment for centuries in the most brutal of societies. it was even endorsed as an effective eugenics tool by such noted historical figures as adolfhitler. the latest form of state-sanctioned castration to appear in society is chemical castration. the use ofdepo-provera injections as a form of chemical castration is a concept that has recently been considered a potentially effective way to handle sex offenders in the united states. the con­ cept of chemical castration does, however, raise several constitutional issues, ranging from cruel and unusual punishment to the violation of equal protection, even if chemical castration could survive these myriad constitutional attacks, states have thus far been unable to create statutes without major flaws. the use ofdepo-provera may have a place within the psychiatric commu­ nity to help cure some sexual disorders, but the judicial system should not make it a condition of parole. indeed, if chemical castration is to be considered a vi­ able option in the united states, prisons should provide psychological treat­ ment, in conjunction with drug therapy, while a prisoner is in custody. this combination of services could potentially resolve a significant portion of the sex offender recidivism problem facing the states. moreover, if states are going to continue relying on statutorily mandated castration to resolve the problems sur­ rounding the rerelease of sex offenders and overcrowding, the drafting legisla­ tures should look to the european legal system for effective methods of implementing and monitoring such programs. baring these changes, the man­ dated castration of sex offenders in the united states should be stopped. in­ deed, castrating sex offenders just simply because they might commit another sex crime should no longer be regarded as an expedient way to create desper122 indiana health law revjew [vol. 5:87 ately needed jail space. rather, state legislatures and the judiciary should re­ gard chemical castration by depo-provera as a treatment, nota punishment. christine nero coughlin christine nero coughlin is a recipient of the 2011 wake forest university teaching and learning center's teaching innovation award, the 2008 jo­ seph branch award for excellence in teaching, and a two-time recipient of the graham award for excellence in teaching legal research and writing. she is a professor and the director of the legal analysis, writing and re­ search program at the law school. she also has faculty appointments in the wake forest university graduate school of arts and sciences where she is a core faculty member of master of arts in bioethics program, and the wake forest university school of medicine's translational science institute. she also teaches in the law school's master of arts in legal stud­ ies program. professor coughlin's teaching and scholarship are concentrated in the areas of legal analysis and writing, bioethics, and health care law. she is a co­ author of the one of the leading textbook in legal writing, a lawyer writes, and has contributed to several texts on legal education and bioeth­ ics. in 2011, professor coughlin developed the legal methods for medical professionals course that enables fourth-year medical students to participate in a month long medical school rotation studying law and the legal system. she is currently working on a text, health law: a context and practice casebook, carolina academic press, for use in such interdisciplinary courses. likewise, her most recent series of law review articles advocate examining other models of professional education to enhance both legal and medical education models. legal methods for medical professionals year 2: shifting negative attitudes christine nero coughlin *i 'there is a stereotype out there that lawyers are dishonest or un­ trustworthy but working with law students, they are very similar to us and just regular people who are trying to help their clients out just like we help our patients out. "2 i. overview of pedagogical theory for medical school course ............................................................................................. 53? ii. overview of social psychology theory for joint professional school class ........................................................ 539 our society has significant and complex issues facing it in the next few years, particularly in the health care arena. in order to solve these prob­ lems, we need education, dialogue and cooperation by all of the relevant stakeholders. our efforts at meaningful health care reform have been hin­ dered, in part, because of a lack of effective communication among the var­ ious stakeholders in the process.3 while this is a long-standing problem with no easy fix, one way to begin to combat the problem is to educate medical students about the rele­ vant legal and political aspects ofhealth care delivery.4 as one of my med* professor and director, legal analysis, writing and research, wake forest university school of law; wake forest university center for bioethics, health and society and wake forest university school of medicine's translational science institute. professor coughlin would like to thank the wake forest university center for bioethics, health and society for their support of this course. 1. this is the third piece that i have written on this concept. the first piece, legal methods for medical professionals: implementing a medical school rotation in the law school to promote greater cooperation and understanding between the professions, 21 annals health l. 257 (2012) (hereinafter "legal methods for medical professionals") discussed the format, objectives, and pedagogical design of the course. the second piece was an op-ed published by the huffington post, training doctors to speak the language of the law, huffington post, http://www.huffingtonpost.com/christine-nero-coughlinldoctors­ health-reform_b_l093133.html (last visited may 19, 2012) (hereinafter "huffington post"). while this piece provides similar background information, its focus is on imple­ menting a process that may shift negative medical student attitudes about the legal system. 2. wake forest university school of law course evaluation for legal methods for medical professionals (feb. 2012) (hereinafter "course evaluation"). 3. see huffington post, supra note 1. 4. see huffington post, supra note l. i discussed in that piece that physicians seem "increasingly frustrated that their elected representatives, oftentimes lawyers, enact laws that 536 indiana health law revffiw [vol. 9:2 ical students recently commented, "[m]y biggest concern still remains about health care is that overall doctors are not involved enough and having law­ yers who are minimally educated in health care [is] not going to create a system that is either efficient or cost effective."5 medical education may further the divide that exists between doctors and lawyers. medical students hear misinformation about medico-legal issues in general, and health care reform in particular, probably due to the increase in media ''sound bites," the lack of accuracy in many internet re­ ports and social networking sites, and increasing political polarization.6 in addition, while "[t]heoretical, scientific knowledge formulated in context­ free and value-neutral terms is seen as the primary basis for medical knowledge and reasoning,"7 the same context-free and value-neutral ap­ proach appears absent if and when future doctors even receive instruction about the legal/political aspect of health care. in their groundbreaking report on the medical education, american medical education 100 years after the flexner report,8 dr. molly cooke and other experts in medical and professional education opine that medical "[ s ]tudents hear institutional leaders speaking more about 'throughput,' 'capture of market share,' ... and the financial 'bottom line' than about the prevention and relief of suffering. students learn from this culture that health care as a business may threaten medicine as a calling. "9 the authors thus conclude that, "[t]he need for a fundamental redesign of medical train­ ing is clear. in some instances, the road that needs to be taken is also clear-for example, more emphasis should be placed on the social, econom­ ic, and political aspects ofhealth care delivery."10 last year, wake forest university school of medicine began offering fourth-year medical students a month-long rotation in legal education housed at the wake forest university school of law.11 one primary goal affect health care policy, and every aspect of patient care, yet these elected officials general­ ly lack any medical training." ld. 5. course evaluation, supra note 2. to illustrate further in january 2011, thomson reuters and hcpiexus published the results of a nationwide survey concerning physician's views on health care reform. 5. a majority of physicians surveyed-sixty-five percent-believe the patient protec­ tion and affordable care act (the "aca"), will cause a decline in the quality of patient care. seventy-eight percent of physicians believe their medical practices will be negatively im­ pacted by the legislation. thomson reuters & hc plexus, the 2011 national physician survey: frustration and dismay in a time of change, available at http://mikemeikle.com/wp-content/uploads/20 11/01/20 11-thornson-reuters-hcplexus­ national-physicians-survey. pdf. 6. see huffington post, supra note 1. 7. molly cooke et a!., american medical education 100 years after the flexner report, 355 new eng. j. med. 1339, 1341 (2006). 8. id. at 1339--44. 9. ld. 10. id at 1342. 11. see legal methods for medical professionals, supra note 1; huffington post, supra note 1. the rotation specifically provided an opportunity for medical students to learn about the political system, about how legal education and the law actually works, how 2012] legal methods for medical professionals 537 was to shift some of the negative attitudes that may exist between physi­ cians and lawyers.12 this essay provides a brief overview of the pedagogi­ cal and social psychology theory used to create a curriculum designed to educate and improve dialogue and cooperation between future physicians and lawyers, along with some empirical findings about the course based on the medical students' evaluations. i. overview of pedagogical theory for medical school course "if young doctors do not feel confident, they are unlikely to challenge poor practice or show leadership in promoting better patient care through using legal rules and an understanding of how law relates to and underpins good medical practice. "13 according to a 2011 study of medical students' experience with the medico-legal curriculum in medical schools in the united kingdom, "[g]ood medical practice requires that medical undergraduates can demon­ strate in practice knowledge and understanding of the law.''14 as dr. cooke and her colleagues noted, ''practitioners need to understand how these is­ sues affect their patients and how to interact with, and ultimately improve, an exceedingly complex and fragmented system to provide good patient care.''is in order to provide an opportunity for these future doctors to demon­ strate in practice "knowledge and understanding of the law," i could not provide the traditional series of readings and lectures about the black-letter law related to complex health care delivery issues. the students needed a holistic understanding of the relevant theories that underlie legal doctrine, along with ample opportunities to apply the theories in realistic simulations, as "[ c ]ognitive psychology has demonstrated that facts and concepts are best recalled and put into service when they are taught, practiced,· and as­ sessed in the context in which they will be used. "16 as one of the medical students reflected on the end of course evaluation, "[!]earning by doing is always better than learning via 'lecture. "'17 the design of the month-long rotation provided these medical students the time to become immersed in the law, just as they had done in their other change in the law occurs, and the theory of how different legal doctrines intertwine in health law and bioethics, all with a special focus on the ethical duties and obligations of both pro­ fessions. 12. id 13. michael preston-shoot et al., readiness for legally literate medical practice? students perceptions of their undergraduate medico-legal education, 31 j. med. ennes 616, 621 (2011). 14. !d. at 616 (internal citations omitted). 15. cooke, supra note 7, at 1341-42. 16. ld. at 1342. ' 17. course evaluation, supra note 2. 538 indiana heal til law review [vol. 9:2 medical school rotations, such as orthopedics or pediatrics.18 specifically, the medical students studied jurisprudential theory such as natural law, positive law, and legal realism.19 they learned about the importance of the rule of law in civilized society.2° further, because health care law is an amalgam of many legal doctrines, the medical students were taught about the theories underlying basic first-year legal education curriculum, such as constitutional law, contracts, torts, and property.21 within each content module, the medical students participated in activities designed to show how the legal doctrines would play out in medical research and their future medical practice. 22 they argued motions, acted as a legislature, constructed a judicial opinion, reviewed a contract, participated in a mediation, etc., all involving health care issues. in addition, during the rotation, the medical students learned how to research and find the law, how to read and interpret case law, statutes, and regulations, along with the process needed to change the law?3 the evaluations from the students were quite positive, with an over­ whelming majority of the students expressing a better understanding of and appreciation for the law, its complexity, and the role oflaw in health care delivery. to illustrate, one representative student's evaluation response was, "i have an increased understanding in the complexity and difficulty of issues regarding the law. i also have a deeper understanding of the ethical decisions that lawyers must face. reading statutes in class also allowed me to understand the importance of interpretation in the law."24 although this class contained a much smaller sample size, the class evaluation was con­ sistent with the findings from the u.k. study that examined the effects of intense legal training during undergraduate medical education and found that medical students' perceptions of medico-legal questions changed after intense legal instruction in the following ways: (1) students decreased their belief that the law was unsuitable for resolving medical issues; and (2) stu­ dents increased their belief that a sound understanding of the law is essen­ tial to being a good doctor.25 18. see legal methods for medical professiomls, supra note 1; huffing ton post, supra note 1. 19. legal methods for medical professiomis, supra note 1; huffington post, supra note 1. 20. see cooke, supra note 7, at 1341 ("'scientific medicine in america ... is today sadly deficient in cultural and philosophical background."). 21. see legal methods for medical professio111jls, supra note 1; huffington post, supra note 1. 22. legal methods for medical professio111jls, supra note 1; huffington post, supra note 1. 23. legal methods for medical professiomls, supra note 1; huffington post, supra note 1. 24. course evaluation, supra note 2. 25. preston-shoot et al., supra note 13, at 617. interestingly, the study also uncovered a negative finding that students' perception that the law encouraged defensive medical prac2012] legal methods for medical professionals 539 ii. overview of social psychology theory for joint professional school class "in everyday life the exchange of opinion with others checks our par­ tiality and widens our perspective; we are made to see things from their standpoint and the limits of our vision are brought home to us. "26 during the rotation, the medical students also participated in a joint class with law students27 and students in our master of arts in bioethics pro­ gram.28 having a joint course was vital to the goal of shifting negative atti­ tudes as, according to social psychology theory, "cooperative interaction with members of a disliked group results in increased likin"g for those mem­ bers and generalizes to more positive attitudes toward the group.''29 in the end, approximately ninety percent of students said that as a re­ sult of the course, their attitudes about lawyers changed?0 representative comments included, "my attitudes have changed toward lawyers. i now have [a] much different opinion of how the legal system and lawyers inter­ act. i also have a better understanding of the difficult decisions that lawyers must make on a daily basis."31 of those that did not report an attitude change, at least one student stated,. i don't believe any of my attitudes about the law have changed. however, i do feel there is a huge benefit in having· interactions with law students as our profestices increased over time. !d. see infra text and note 50. 26. cass r. sunstein, deliberative trouble? why groups to extremes, 110 yale l.j. 71, 71 (2000)(quoting john rawls, a theory of justice 358-59 (1971)). 27. while not in the scope of this essay, the law students also reported positive educa­ tional results from exposure to medical students in a joint course. as one scholar who creat­ ed a similar program for law students in a medical center noted, exposure of the law student to medical practice is of utmost importance because legal training differs from medical education in one salient as­ pect. the law student analyzes the rationale for, the doctrinal aspects of, and the social policy behind a rule of law or statute. as a corollary, the prerequisite to legal analysis is an understanding of the particular fact situation to which the law applies. once he comprehends medical prac­ tice, the future attorney not only can articulate his client's medical-legal problem clearly and accurately but also can evaluate. the doctrinal and social policy aspects of any court decision, proposed legislation, statute, or rule of law pertaining to a medical-legal problem. in other words, he is a better advocate. c.w. quimby, jr. et al, the medical school's role in legal training, 47 j. med. eouc. 575, 575 (1972). 28. see legal methods for medical professionals, supra note 1; huffington post, supranote l 29. donna m. desforges et. al., effects of structured cooperative contact on changing negative attitudes toward stigmatized social groups, 60 j. personality & social psych. 531,531--44 (1991). 30. course evaluation, supra note 2. 31. ld. 540 indiana health law review sions do have a linked relationship. i enjoyed getting to meet and interact with soon to be lawyers, as i have had little interaction to this point.32 [vol. 9:2 in addition, approximately eighty-one percent of students stated that they would be more likely to participate in the political process as a result of the course. for example, one student stated, "i would be likely to work for a change in the law and participate in political discussions regarding reform-i feel strongly about my beliefs and am willing to compromise if the solution is viable. "33 designing a curriculum to shift negative attitudes can be tricky due to concerns about manipulating results and avoiding possible group extrem­ ism. professor cass r. sunstein, in his essay deliberative trouble? why groups go to extremes/4 explains the psychological mechanism and the dangers of attitude changes as a result of group interaction: the underlying mechanisms are twofold. the first involves people's desire to stand in a particular rela­ tion to the group, perhaps for reputational reasons, perhaps to maintain their self-conception. shifts oc­ cur as people find that it is necessary to alter their po­ sitions in order to maintain their self-conception or their desired relation to the group. the second mech­ anism involves limited 'argument pools,' .... when arguments are skewed toward a particular point of view, group members will move in the direction of that point of view. in a finding of special importance to democratic theory, group polarization is heightened if members have a sense of shared identify. and in an equally important finding, group polarization is di­ minished, and depolarization may result if members have a degree of flexibility in their views and groups consist of an equal number of people with opposing views.35 the challenge, therefore, was to find a curricular design whereby the professional students could join together and learn about health law and bioethics in a cooperative manner, develop a positive group identity in an environment with ample opportunity for flexibility of views so as to avoid 32. id. 33. id 34. sunstein, supra note 25. 35. id. at 118. 2012] legal methods for medical professionals 541 manipulation of results, and to encourage democratic theory to work. 36 my efforts to meet this challenge resulted in a joint class two after­ noons per week. where the medical students joined law students and bioeth­ ics students in learning about health law and bioethics. for every content module, the students jointly participated in realistic legal/medical, biotech­ nical and research-related. scenarios, such as a clinical ethics consultation, an investigational review board meeting, an appellate argument, as well as a medical malpractice negotiation and mediation, and class-related social ac­ tivities and opportunities.37 the students were assigned roles (patient, doc­ tor, judge, lawyer, congressional representative, agency representative, ethics committee members, etc.) for the simulation opposite their field of study.38 so, for example, the law students were assigned to be physicians, nurses, clinicians; researchers, or patients, and the medical students per­ formed the role of lawyer, in-house counsel, judge, client, etc.39 the students were required to resolve the medico-legal conflict issues and discuss the valid competing professional and social interests at play based on their assigned role.40 in doing so, the students had to consider the humanistic element-how would a person in a certain role react, and what ethical choices might he or she have to make't1 this design twist was nec­ essary because ''the students, even at this early stage in their professional careers, had already formed strong views and biases about the roles of phy­ sicians and lawyers in resolving conflict.'.42 as i explained in legal meth­ ods for medical professionals: implementing a medical school rotation in the law school· to promote greater cooperation and understanding be­ tween the professions: their assigned roles motivated them to dispassionate­ ly evaluate all potential arguments, as well of a range of appropriate actions, even those they may not per­ sonally or professional agree with (i.e., bringing a 36. seeid. 37. see legal methods for medical professionals, supra note 1; huffington post, supra note 1. for example, we had a opening lunch and closing reception, graciously funded by the wake forest university center for bioethics, health & society. the students also participated in joint group activities where they had to meet outside of class, as well as a book club meeting on the book next by michael crichton. the student groups coordinated where they would have the book club meetings and chose local coffeehouses, restaurants, etc. the students then sent pictures of the various participants in the venues where the book club meetings took place. 38. see legal methods for medical professionals, supra note 1; huffington post, supra note 1. 39. see legal methods for medical professionals, supra note 1; huffington post, supra note 1. , 40. see legal methods for medical professionals, supra note 1; huffington post, supra note 1. 41. see huffington post, supra note 1. 42. legal methods for medical professionals, supra note 1, at260. 542 indiana health law review lawsuit against a healthcare provider or ruling in favor of a medical malpractice plaintiff and against a health care provider). in addition, role-playing "protected them from having to defend or change their own per­ sonal beliefs. as a result, students [were] less likely to create internal psychological or social barriers to opposing views.',..3 [vol. 9:2 the students acknowledged that in order to make the simulations work (given their unfamiliar assigned roles), they needed the benefit of the other students' expertise. as one student commented: "i enjoyed having a mix and it really showed that when it comes to medical-legal issues both· sides need to work together because the med students need help with the legal aspects and the lawyers need help with the medical aspects.'m this year, every student participated in every simulation;45 thus, we had multiple simulations occurring at the same time. following each simu­ lation, the students all reconvened in the classroom for a "post-mortem" discussion.46 the students discussed the simulation, what occurred, and the differences between the roles they played in the simulation and their per­ sonal views on the topic. the post-mortem exercise was critical. as one of the medical students noted in his course evaluation: just talking to other students and finding out their ideas about things. some ideas are so polar opposite to yours you can't believe it-but that makes it way more interesting. so many times i came home to oth­ er friends and said "ok we had a big debate about this topic-what do you think.'' that's when you know the class makes a difference, when the students are continuing to debate after school hours.47 another reflected, "i don't feel any of my attitudes on health care have changed but rather have been reinforced or questioned through the course of 43. id at 26(h)l. (internal citations omitted). 44. course evaluation, supra note 2. 45. last year, we divided up the students and ran one simulation at a time. students not participating watched and would comment during the reflection period. this year, i ran multiple simulations, and then everyone came together to discuss the results of the various simulations. this year's method was preferable as active learning exercises are always more interesting and more educationally profitable. see christine coughlin et al., see one, do one, teach one: dissecting the use of medical education's signature pedagogy in the law school curriculum, 26 ga. st. u. l. rev. 361, 397 (2010). in addition, we were able to discuss in class the reasons that simulations did not result in the same conclusion which made for some fascinating group discussion. 46. legal methods for medical professionals, supra note 1, at 260. 47. course evaluation, supra note 2. 2012] legal methods for medical professionals 543 this class. i feel that having multiple opinions presented and discussed only further strengthens ones' own knowledge on the subject.',.;8 the post-mortem reflection period provided my most memorable moments of the class-where i was not the "sage on the stage',.;9 but was listening to the passionate dialogue from the students. i frequently had those incredible teaching moments where multiple students want to com­ ment, and i simply kept a list of all who would be sharing their comments. one of my favorite classes involved a simulation on preimplantation genetic diagnosis. while the simulation included a variety of sub-issues, the primary storyline involved a family who wanted to test embryos for both a genetic and cosmetic reason. in the hypothetical, the family and physician received negative press and the physician was ultimately crimi­ nally charged under a broadly drafted statute that arguably restricted any type of embryonic testing or manipulation. the students were assigned various roles (again opposite their fields of study), read many articles on the medical, ethical and legal aspects of the procedure, and were exposed to a variety of viewpoints on the range of pos­ sible responses. the students were charged with creating a legislative re­ sponse. the groups' responses ranged from allowing science to advance with no restrictions, to a moratorium or ban on the procedure while further study was completed. some groups took the middle ground approach and tried to draft legislation or policy on this issue that would allow the proce­ dure to be performed in a limited manner. they learned how difficult it is to draft legislation that is neither too narrow nor too broad (or does not fail for vagueness or ambiguity). when the class met to reflect, they were amazed at the variations in the groups' responses. we discussed the fact that with many medico-legal issues, there are actually more than two sides to the story. we had a heated discussion on the role that religion, spiritual beliefs, socioeconomic con­ cerns, and political preference may play in a political response, or lack thereof. as one student stated in the evaluation, 48. /d. [i]t's easy to come into the class having stereotypical thoughts regarding lawyers-ruthless, ambulance­ chasing, etc. learning more about the law and the in­ tricacies involved, knowing that its very easy to have two, three, four sides to a story gives the [legal] pro­ fession a lot more credibility in my eyes. things are not always black and white, and ethical and moral di49. alison king, from sage on the stage to guide on the side, 41 c. teaching 30, 30-35 (1993). 544 indiana health law review [vol. 9:2 lemmas really require lawyers for the public good. 50as with all courses, i intend to make some changes next year. one ar­ ea i will look at is the amount of reading for the medical students. one crit­ icism in the evaluation by the medical students was. the amount of reading. while this is an age-old comment that most law professors have seen on their evaluations, i had added some additional reading assignments this year; however, as one student explained, medical students are not used to some of the denser reading that [was] assigned. while all assignments were appropriate, i felt the class would benefit from using readings of a shorter nature. in addition, i felt some of the issues we discuss could have been made even more interesting by taking excerpts· from some of the court opinions on said subjects. 51 although i firmly believe in the benefits of the assigned readings, i will likely examine the reading and see if there is a way to pull some excerpts for some of the assignments. another change i plan to implement is to have the law and bioethics students who participate in the joint class shadow a physician. as one med­ ical student noted, "i do wish there was someway that one day the law stu­ dents could come to the hospital and spend a day on the wards, or just a morning so they can see what all goes into our job.''52 i will also add additional features to the medical malpractice and ne­ gotiation simulations. i felt these were important simulations, since medi­ cal malpractice is often the elephant in the room when discussing relations between doctors and lawyers. two years ago, we discussed medical mal­ practice during the last class. we were discussing the practice of naming all parties listed in the medical records in a lawsuit until such time as discovery took place and defendants dismissed. at that time, one impassioned medi­ cal student told the class, "[t]his could be me you are talking about suing."53 the class ended on a sour note for that medical student. as a result, this year i added more time on the medical malpractice module and conducted several relevant simulations earlier in the rotation. instead of providing the 50. course evaluation, supra note 2. 51. jd. 52. course evaluation, supra note 2. although beyond the scope of this essay, another area that i would like to explore is the effect of immersion education for both law and medi­ cal students in creating more empathy. see, e.g., sonia j. crandall & gail s. marion, identi­ fying attitudes towards empathy: an essential feature of professionalism, 84 acad. med. 1174 (2009). 53. remarks during a wake forest univ. school of law legal methods for medical professionals class (feb. 10, 2011 ). 2012] legal methods for medical professionals 545 story of a doctor who had been sued, i thought a more empathetic discus­ sion would occur if a lawyer who was sued for legal malpractice came in and told her story. following that class, the medical students told me that they would like to hear stories from both a doctor and a lawyer who were sued for malpractice, as well i as from both a plaintiff and defense medical malpractice attorney. • professional attitudes b~een doctors and lawyers need to change. 54 in order to create a shift in tile tide, however, professional schools need to provide educational opportunities for all of the relevant future stakeholders to discuss and debate the important issues in a cooperative manner. one way to do this is to implemetllt a medical school rotation in the law school that incorporates significant 'pportunities for educational and professional communication and interactiopg. as one student reflected: yes my attitude ·as changed. i think it was very good for me to see things from a lawyer's perspective. there are definite misconceptions out in the world about lawyers and ere is the same thing for doctors. there are people at go out and give the field a bad image; however, i )enjoyed many of the activities that were done throughout the class and i found many parts of being a lawyer interesting. i think getting to know the law students and also having to 'think' like a lawyer is what helped me change my attitude the most. 55 54. of course, for sustained change, "continuing professional development [is needed] to enhance doctors' confidence in engaging when necessary with the legal system." preston­ shoot et al., supra note 13, at 621. 55. course evaluation, supra note 2. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i when the physician says you have to get the shot, but mommy says no: the cases of taige mueller and daniel hauser, and how the state may force parents to accept unwanted medical treatment for their children zach williams • i. introduction .•.•••....•••....•...•.••••.•.•.•.•....•..•..•.•.•...••••.•..••......•.....•.•. 199 a. the issue ................................................................................... 200 b. roadmap ................................................................................... 201 ii. background ................................................................................ 202 a. the case oftaige mueller ........................................................ 202 b. the incident involving daniel hauser ...................................... 203 c. background of the law ............................................................. 204 1. the interest of the parent ................................................... 204 2. the interests of the state ..................................................... 205 3. how things work procedurally ......................................... 206 d. the cause for concern according to parents .......................... 207 e. the cause for concern according to the state ......................... 207 f. the cause for concern according to the physician ................. 208 iii. analysis ....................................................................................... 209 a. examining the mueller civil suit.. ............................................ 209 b. examining the hauser events ................................................... 211 c. medical testimony .................................................................... 212 d. procedural complications ........................................................ 215 e. did neglect mandate state intervention? ................................. 217 f. policy arguments ...................................................................... 218 1. protecting the child ............................................................ 219 2. parental autonomy ............................................................. 220 3. the physician's role ........................................................... 221 4. state actors charged with deciding what to do in dijjicult situations ............................................................... 222 5. the state (legislature) ........................................................ 223 g. possible solution to a complicated problem ........................... 223 n. conclusion .................................................................................. 227 i. introduction at first glance, it seems difficult to imagine a scenario in which a • j.d. candidate, 2011, indiana university school of law indianapolis; b.a., 2004, indiana university. 200 indiana health law review [vol. 8:199 competent parent would refuse medical care for their child. however, what if the proposed treatment for the child is dangerous, or the parent feels that another course of treatment would be safer for the child, or what if the par­ ent simply does not trust the medicine that is being recommended? if a parent refuses medical treatment for his or her child, the state could inter­ vene and take that child away, forcing the refused treatment on the child despite any fears or apprehensions from the child's parent. 1 imagine that your infant child is ill, and you bring her to the hospital. the doctor wants to do a spinal tap, a possibly risky procedure for an infant. you argue with the physician and strongly feel the procedure is unneces­ sary. instead of the physician following your wishes, he instead contacts the police and child services departments. the authorities refuse to defer to your opinion on how to care for your infant daughter, and instead take cus­ tody of her. the state then approves the spinal tap procedure on your in­ fant, and she remains in their custody for the rest of the day. as the ordeal ends, you discover that your daughter was fine all along. this hypothetical may invoke some complicated emotions for many parents, but it is important to recognize the other parties involved in this situation: the incompetent child, the concerned physician, and the state it­ self, which is charged with protecting the child's welfare.2 thus, it is pos­ sible that the physicians and state authorities in the above scenario believed they were acting in the best interest of the child, and the parent's wishes were ignored as a result. the above hypothetical is a catalyst for debating parents' autonomy in caring for their child, contrasted with the state's interest in protecting the child when it believes the child's safety may be at risk. however, this is not a hypothetical, as this scenario actually occurred. 3 a. thelssue the central issue of this controversy comes from a struggle between parents choosing what medical care they believe is best for their child and the state disagreeing with that choice. the fourteenth amendment of the united states constitution has long protected the rights of citizens! from this protection, the supreme court of the united states has inferred that a competent person has a protected liberty interest in choosing to refuse un­ wanted medical care.5 in the common law, children in our society are deemed to be incompetent, and unable to make decisions regarding their 1. see custody of a minor, 393 n.e.2d 836, 843-44 (mass. 1979); people ex rei. wallace v. labrenz, 104 n.e.2d 769, 773 (id. 1952). 2. see prince v. massachusetts, 321 u.s. 158, 165 (1944). 3. see mueller v. auker, 576 f.3d 979 (9th cir. 2009). 4. u.s. const. amend. xiv. 5. see cruzan v. director, missouri dept of health, 497 u.s. 261,278 (1990). 2011] the cases of t aige mueller and daniel hauser 201 medical care.6 instead, the decision to accept or refuse medical treatment is left to the child's parents.7 this note discusses the difficulties that arise when the decision to treat is taken away from the parents, because the state believes the child's welfare may be at risk.8 specifically, this note looks at what happens when the decision centers on a parent's desire to refuse medi­ cal care for their child because the parent believes the care to be unneces­ sary, dangerous, or simply unwanted, as demonstrated by the cases of taige mueller,9 and daniel hauser. 10 b. roadmap this note identifies the factual background of the case of taige mueller11 and compares it with the situation involving daniel hauser, who along with his parents, disagreed with the prescribed treatment to battle the cancer that had infiltrated his body, but was forced to follow the orders of his physicians through intervention from the state. 12 the case involving taige mueller was heard in june of 2010, with a jury finding that the sei­ zure of taige from her mother's custody did not amount to a violation of any of her parents' constitutional rights.13 the controversy surrounding daniel hauser is next contrasted with taige mueller's experience, to exam­ ine the inherent difficulties faced by parents, physicians, and the state in determining who should decide the course of treatment for a sick child. this note also briefly examines the current state of the law in regards to the state's authority and duty to a sick child whose parent decides against or disagrees with prescribed medical treatment for her child. it will then analyze the current state of the law in regards to the mueller and hauser scenarios, while examining the roles that each interested party (parent, phy­ sician, and state) played in the process.14 by highlighting the difficulties faced in balancing the parents' right to care for their child with the state's 6. melinda t. derish & kathleen v. heuvel, mature minors should have the right to refose life-sustaining medical treatment, 28 j.l. med. & elhics 109, 110 (2000). 7. see id. (arguing that the current state of the law denying mature children the right to refuse medical care should be changed). 8. see custody of a minor, 393 n.e.2d 836, 843-44 (mass. 1979); people ex rel. wallace v. labrenz, 104 n.e.2d 769, 773 (ill. 1952). 9. mueller v. auker, 576 f.3d 979 (9th cir. 2009). 10. aaron cooper & chris davis, judge orders chemotherapy for 13-year-old can­ cer patient, cnn, (may 26, 2009), http://www.cnn.com/2009/us/05/26/minnesota.forced .chemo/index.html. 11. mueller, 576 f.3d at 982-87 (9th cir. 2009). 12. see cooper & davis, supra note 10. 13. press release, the center for individual rights, the latest news from cir: jury finds no liability in mueller case (june 30, 2010), available at http://www.cir­ usa.org/updates/index.html. 14. the role of the child in the decision-making process is outside of the scope of this note, which instead chooses to focus on the parties who are practically involved in deciding what kind of medical care the child should receive. 202 indiana health law review [vol. 8:199 interest in protecting the welfare of the child, 15 this note attempts to flesh out the inherent problems in the current approach to this issue. finally, this note suggests a procedure by which the interests of the parties could be balariced fairly, while maintaining the child's safety. ii. background a. the case oftaige mueller in 2002, corissa mueller's five·week-old infant daughter, taige, became ill and began running a fever. 16 corissa consulted with taige's family physician over the phone, and the physician suggested possible causes for taige's fever. 17 the family physician discussed the probable procedures that taige would undergo if corissa chose to take her to the hospital.18 one of the potential examinations involved a spinal tap pro­ cedure to check for meningitis.19 a spinal tap procedure consists of a needle being placed in between two vertebrae in order to remove cere­ brospinal fluid for testing. 2° corissa discussed the treatment protocols with her husband, eric mueller.21 after receiving reassurance from taige's family physician, taige's parents believed they would have the ability to withhold consent should the hospital physician recommend the spinal tap procedure. 22 corissa took taige to the hospital while eric mueller, taige's fa­ ther, remained at home to care for the couple's other child.23 the hos­ pital physician examined taige and recommended various examinations including a spinal tap and administration of prophylactic antibiotics, and also warned that there was a five percent chance that taige had meningitis.24 corissa disagreed with·the doctor's assessment, based on her own research about taige's risk. for meningitis.25 after taige's temperature began to drop, corissa refused to consent to the spinal tap procedure.26 the hospital physician in charge oftaige's care contacted 15. see prince v. massachusetts. 321 u.s. 158, 166 (1944) ("[t]he custody, care and nurture of the child reside first in the parents, whose primary function and freedom· include preparation for obligations the state can neither supply nor hinder."). 16. mueller, 516 f.3d at 982-83. 17. id 18. id at 983. 19. id 20. lumbar puncture {spinal tap), mayo clinic. (jan. 23, 2010) http:/lwww.mayoclinic.com/healthllumbar-puncture/my00982. 21. mueller, 516 f.3d at 983. 22. id 23. id 24. /d. 25. id. 26. id. at 983-84. 2011] the cases of taige mueller and daniel hauser 203 child protective services ("cps"), and a detective from the local police department was dispatched along with cps workers. 27 based on the physician's insistence that time was limited (i.e., three hours), and co­ rissa's refusal to consent to the spinal tap, the detective declared taige to be in imminent danger and removed her from her mother's custody.28 corissa was restrained and confined to a small room while "screaming and yelling" the entire time. 29 hospital physicians obtained the neces­ sary consent from cps, who had already assumed custody of taige, and then conducted the spinal tap procedure against the wishes of taige's mother. 3° corissa was prohibited from informing her husband over the phone, and she was not reunited with her daughter until a day later.31 the results of the spinal tap procedure were negative.32 b. the incident involving daniel hauser in 2009, thirteen-year-old daniel hauser and his mother fled their home after a judge ordered that daniel comply with his physician's rec­ ommendation to begin chemotherapy to treat daniel's cancerous tu­ mors.33 daniel had been diagnosed with hodgkin's lymphoma in january of 2009.34 initially, daniel's parents consented to the treatment recommended by daniel's treating physician, and daniel was given an initial round of chemotherapy.35 daniel's parents allegedly became fearful of the side effects of chemotherapy after the initial treatment, and decided to pursue an alternative treatment plan. 36 after daniel failed to show up for further treatments, his physician became concerned and left a voice message on the hauser's phone threatening to call the authorities if daniel did not resume his chemo­ therapy.37 after receiving no response from the hausers, daniel's phy­ sician contacted the authorities. 38 court documents reveal that the 27. ld at 984. 28. jd 29. /d. at 985. 30. id at 986. 31. id at 983-86. 32. amy sorrel, idaho emergency physician sued for overriding parent's decision, am. med. news, (apr. 9, 2007), http://www.ama-assn.org/amednews/2007/04/09/gvsb0409. htm. 33. see cooper & davis, supra note 10. 34. mother, son mwing in forced chemotherapy case, cnn, (may 20, 2009), http://www.cnn.com/2009/us/05/19/minnesota.forced.chemo/index.html [hereinafter moth­ er, son missing]. 35. /d. 36. /d. 37. chris welch, father appeals to his wife to return with their cancer-stricken son, cnn, (may 21, 2009), http://www.cnn.com/2009/us/05121/minnesota.forced.chemo /index.html. 38. /d. 204 indiana health law review [vol. 8:199 judge had ordered daniel to undergo an examination, and that daniel had actually undergone the procedure; however, daniel and his mother disappeared the day before they were scheduled to appear.39 as a re­ sult, the court removed daniel from his parent's custody and authorized police officers to apprehend the missing child.40 daniel's father pled with the mother-son duo to return home so that the dispute could be set­ tled "as a family."41 daniel and his mother eventually returned and consented to treat­ ment following a hearing in which the judge ordered treatment at the risk of daniel being removed from his parent's custody.42 fortunately, as of his fourteenth birthday, daniel was free of cancer. 43 c. background of the law there are two competing interests immediately evident when re­ viewing the mueller and hauser situations: the parent and the state. when these two interests collide on the issue of selecting medical care for a sick child, then scenarios like those described above are entirely possible. 1. the interest of the parent supreme court precedent has established that the custody and care of children resides with their parents.44 parents are given leeway to care for their children without interference from the state.45 in addition, this right is constitutionally protected: "parents and children have a well-elaborated constitutional right to live together without governmen­ tal interference. that right is an essential liberty interest protected by the fourteenth amendment's guarantee that parents and children will not be separated by the state without due process of law except in an 39. order to apprehend and detain, in re hauser, no. n-09-068, at 5 (minn. dist. ct. may 19, 2009 ), available at http://www.nmcourts.gov/documents!o/public/other/hauser/ order_to_apprehend_and_detain.pdf (ordering police to apprehend and detain daniel hauser). 40. ld. 41. see welch, supra note 37. 42. order, in re hauser, no. jv -09-068, at 7 (minn. dist. ct. may 26, 2009), available at http:/ /www.mncourts.gov/documents/0/public/other/hauser/order5 .27 .09 .pdf (forcing daniel's parents to follow the prescribed treatment of daniel's physicians, less he be re­ moved from their custody). 43. scott wasserman, daniel hauser turns 14, is cancer free, fox 9 news ksmp­ tv, (mar. 28, 2010), http://www.myfoxtwincities.com/dpp/news/daniel-hauser-turns-14,­ is-cnacer-free-mar-28-2010. 44. see prince v. massachusetts, 3,21 u.s. 158, 166 (1944). 45. see santosk:y v. kramer, 455 u.s. 745 (1982). 2011] the cases of taige mueller and danmlhauser 205 emergency."46 thus, the law assumes that the parent of a sick child will act in that child's best interest.47 a competent person has a constitu­ tionally protected interest in refusing medical treatment, 48 but a child is not automatically considered competent in the eyes of the law.49 there­ fore, the decision of whether or not a child should receive medical treatment traditionally falls to the child's parent. 5° returning to the case of taige mueller, the presumption that parents will act in their child's best interest can be readily applied. taige's mother had conducted her own research on the spinal tap procedure and believed that the risks of the spinal tap procedure outweighed its benefits. 51 ulti­ mately, corissa mueller believed the risk of taige having meningitis to be less than one percent and, as a result, saw no need to subject her daughter to the procedure·52 taige's mother came to a rationally sound decision based on her own interpretations of the spinal tap procedure and decided to forgo the treatment in what she considered her child's best interest53 viewing only the principles concerning a parent's interest in car­ ing for his or her child, it would seem that corissa mueller's decision would be protected and require no further interference from the state. seemingly, these principles would also protect the decision by daniel hauser's parents. however, this analysis fails to consider the state's competing interest. 2. the interests of the state "[t]he state has a long-standing interest in protecting the welfare of children living within its borders.'.s4 therefore, despite a parent's interest in caring for his or her child without interference from the state, the state may interfere if a child's well-being is at risk. 55 the state may intervene in extraordinary circumstances (e.g., when the child's life may be in danger) by temporarily removing the child from the parent's custody. 56 the state's concern arises from its interests in: (1) the preservation of the welfare 46. see wallis v. spencer, 202 f .3d 1126, 1136 (9th cir. 2000). 47. see generally thomas jacobs, 2 clm..dren & tile law: rioms and 0buoations § 10:3. 48. see cruzan v. director, missouri dept. of health, 497 u.s. 261 (1990). 49. see derish & heuvel, supra note 6, at 110. 50. see bartal v. brower, 993 p .2d 629 (kan. 1999); belcher v. charleston area med. ctr., 422 s.e.2d 827 (w.va. 1992). 51. mueller v. auker, 576 f.3d 979, 983 (9th cir. 2009). 52. id. 53. id. at 984. 54. custodyofaminor,379n.e.2d 1053,1066(mass.1978}. 55. wisconsin v. yoder, 406 u.s. 205, 233-34 (1972) (holding, "[t]he power of the parent ... may be subject to limitation ... if it appears that parental decisions will jeopardize the health or safety of the child.''). 56. bendiburgv. dempsey, 909 f.2d463, 467 (llthcir. 1990). 206 indiana health law review [vol. 8:199 of the child57 and (2) the doctrine of parens patriae, 58 or the authority to protect children from negligent parenting. 59 these two interests may overlap, as the well-being of the child may directly coincide with whether his parents are deemed negligent in their choice of medical care. additionally, a parent's decision could affect the well-being of the child in such a way that both of the state's interests are adversely affected. there is a presumption that parents will act in the best interest of their children.60 however, this presumption may be rebutted when a parent refuses medical care for her child that the state believes is neces­ sary to secure that child's well-being.61 seemingly, this would mean that in order for the state to step in against a parent's wishes, the parent would be deemed unfit to care for her child, at least in that particular instance. 3. how things work procedurally when the state takes a child into custody; the parents generally have a right to a pre-deprivation hearing before custody of the child is taken away. 62 nevertheless: [w]hen the state has "reasonable cause to believe that the child is in imminent danger of serious bodily injury and ... the scope of the intrusion is reasonably necessary to avert that specific injury," a state has the authority. without prior judicial authorization to com­ pel a minor cbild to undergo specific medical treat­ ment over parental objections. 63 in mueller, the officer believed that taige was in imminent danger because of the risk of meningitis and a limited time in which to act.64 for daniel hauser, his physicians believed that there was a high likeli­ hood of curing him with treatment, but that failure to treat would likely 57. custody of a minor, 379 n.e.2d at 1066. 58. parens patriae literally means "parent of his or her country" and refers to the role of the state as guardian of persons under legal disabilities, such as juveniles or incompetent persons. black's law dictionary, 1144 (8th ed. 2004) .. 59. john e.b. myers, neglect of children's health: too many irons in the fire, 8 j.l. fam. stud. 317,318 {2006). 60. see, e.g., troxel v. granviue, 530 u.s. 57 {2000). 61. parham v. j.r., 442 u.s. 584,604 (1979). 62. see mueuer v. auker, 576 f.3d 979, 995 (9th cir. 2009); stanley v. illinois, 405 u.s. 645 (1972). 63. mueller, 516 f.3d at 995 (quoting wallis v. spencer, 202 f.3d 1126, 1138 {9th cir. 2000)). 64. mueller, 516 f.3d at 984-985. 2011] the cases of taige mueller and daniel hauser 207 be fatal.65 simply from reading the factual patterns of both taige mueller's and daniel hauser's respective cases, it is evident that the imminence and seriousness of the medical condition directly affects the procedural outcome from the parent's perspective. this notion is supported by the fact that taige mueller's parents did not receive any sort of pre­ deprivation hearing regarding the custody of their daughter, seemingly because of the imminence and seriousness of the medical condition.66 generally, parents are entitled to a hearing before their children can be taken away from them. 67 the exception to this rule comes into effect when the state believes that the child is in imminent danger, and the interference is necessary to avoid injury.68 d. the cause for concern according to parents based on the above principles, in certain situations parents may have little choice when it comes to their child's medical care, especially when the parents disagree with the child's physician, and the physician feels strongly enough to involve the state. this idea is compounded by the general principle that the state will leave the child's well-being in the par­ ent's control, unless the parent's actions put the well-being of the child at risk. 69 this could mean that simply disagreeing with a physician who feels strongly enough about the child's care may be enough to rebut the presump­ tion that parents are fit to care for their children. this very real potential for losing the ability to choose medical care for their child would erode the au­ tonomy that is granted to them in caring for their child. 70 e. the cause for concern according to the state there are also difficulties from the state's perspective. these difficul­ ties arise because "neither the state nor private actors, concerned for the medical needs of a child, can willfully disregard the right of parents to gen­ erally make decisions concerning the treatment to be given to their chil­ dren."71 for example, the state will not order a blood transfusion if the 65. judge rules family can't refuse chemo for boy, msnbc (may 19, 2009), http://www.msnbc.msn.com/id/30763438/nslhealth-kids_and_parentingl [hereinafter judge rules family can't refuse c1jemo]. 66. mueller, 576 f .3d at 979, 982. 67. see stanley, 405 u.s. 645. 68. wallis, 202 f.3d at 1138 69. wisconsin v. yoder, 406 u.s. 205, 233-34 (1972) ("the power of the parent ... may be subject to limitation ... if it appears that parental decisions will jeopardize the health or safety of the child"). 70. see cases cited supra notes 44-46 and accompanying text 71. bendiburgv. dempsey, 909 f.2d463, 470 (llthcir. 1990). 208 indiana health law review [vol. 8:199 child's medical condition is not life-threatening, and the parents object to the procedure. 72 in addition, the state is unlikely to remove the child from the parent's custody and let the physician make the decision alone where the treatment is considered highly dangerous and the likelihood of success is not particularly certain.73 this further serves to indicate the importance of the state carefully weighing each individual case based on numerous fac­ tors, including the child's condition, the time under which to treat, and the parent's wishes.74 the problem with this approach is that there may be oth­ er instances like that in mueller, where a physician may believe immediate action is required, and the state is pressured into making a quick decision. in these cases, it will be difficult for the state to balance the parents' interest in caring for their child75 and the state's interests in protecting the child's well-being.76 f. the cause for concern according to the physician finally, there is a third player involved in scenarios like mueller and daniel hauser's situationthe physician. physicians are charged with car­ ing for their patients. 77 therefore, when a physician feels strongly enough about a treatment option, he or she may disregard the wishes of a parent by involving the state, in order to secure what is believed to be the safest out­ come for the child. this was seen in mueller. 78 the physician refused to concede to corissa mueller's wishes, and instead decided to involve the police and cps. 79 the physician stated that if he followed corrissa mueller's wishes with all his patients, five out of every hundred would die, and that would be unacceptable.80 it should be noted that the physician's assessment of the risk was called in to question in a lawsuit filed by the muellers. 81 in these situations, physicians may further complicate the issue if they do not consider the parents' right to care for their child without inter72. see, e.g., in re e.g., 549 n.e.2d 322 (ill. 1989). 73. see, e.g., newmark v. williams, 588 a.2d 1108 (del. 1991) (deciding to not order child with cancer to undergo radical form of treatment with a success rate of only forty per­ cent). 74. see mueller ex rei. mueller v. auker, no. cv-04-399-s-blw, 2007 wl 627620, *14 (d. idaho feb. 26, 2007) (discussing what the state actor's analysis should include "the desires of the parents, their fitness, the risks of treatment compared with the risks of forego­ ing treatment, how soon the harm will occur, whether there is time to contact a judge, and any other factors given the circumstances."). 75. see prince v. massachusetts, 321 u.s. 158, 166 (1944). 76. see custody of a minor, 379 n.e.2d 1053, 1066 (mass. 1978). 77. see generally the hippocratic oath: modern version, nov a, http://www. pbs.org/wgbh!nova!doctors/oath_modem.html (last visited, oct. 15, 2010). 78. mue1ler v. auker, 576 f.3d 979 (9th cir. 2009). 79. id. 80. ld. at 984. 81. mueller ex rei. mueller v. auker, no. cv-04-399-s-blw, 2007 wl 627620, *25 (d. idaho feb. 26, 2007). 2011) the cases oft aloe mueller and daniel hauser 209 ference from the state.82 ultimately, the state is charged with settling these disputes between physicians and parents. in mueller, the physician and the state ordered a procedure that was unnecessary in hindsight, and one that taige's mother expressly forbade the physician from performing. 83 in daniel hauser's case, treatment was prescribed that he and his parents did not agree with, and daniel was eventually forced by the court to accept that treatment. 84 in both situations, the wishes of the parents were pushed aside in favor of the state's interest in protecting the child's well-being. the underlying ques­ tion is whether these two scenarios could have been handled better. iii. analysis these two instances provide a backdrop for analyzing the positive and negative aspects that the state must confront when a parent refuses medical care that a doctor feels is necessary to protect the child's life. this note describes how one result turned out the "right" way, and the other ended the ''wrong" way. a. examining the mueller civil suit taige mueller's role in the issue of forced medical care is useful for analyzing how the law applies when the state decides to intervene. more importantly, taige's case may also provide a window into how the judicial system views these scenarios. after their daughter was taken from them and given the spinal tap procedure, taige's parents brought a civil suit against multiple parties involved in taige's treatment and the eventual spinal tap procedure.85 the suit included taige's physician, the detective that removed taige from her mother's care, and the state social worker who ultimately con­ sented to the procedure after custody of taige was taken away.86 the muellers were aided in their suit by a washington d.c. based civil rights group. 87 the trial was set for june of 2010, and was decided by a 82. see santosky v. kramer, 455 u.s. 745 (1982). 83. sorrel, supra note 32. 84. order, in re hauser, no. jv-09-068 (minn. dist. ct. may 26, 2009), available at http:/ /www.mncourts.gov/documents/0/public/other!hauser/order5.27 .09.pdf (order by the court forcing daniel's parents to follow the prescribed treatment of daniel's physicians, less he be removed from their custody). 85. see mueller ex rei. mueller, 2007 wl 627620, at *15-26 (discussing the individu­ al defendants' roles in what transpired during the time when taige was taken from her par­ ents). 86. /d. 87. see mueller v auker: parents ' right to make medical decisions at stake in law­ suit, the center for indmdual rights, http://www.cir-usa.org/cases/mueller_v_idaho. html (last updated may 20, 2010). 210 indiana health law review [vol. 8:199 jury in favor of the defendants.88 without a judicial opinion to evalu­ ate, it is impossible to know exactly how the case played out in front of a jury, however, the events leading up the trial give some window into how courts may view similar situations. the main issues in the suit focused on both the substantive and procedural due process rights of taige's parents, as well as whether those rights were violated when their daughter was given the spinal tap procedure against their wishes.89 before the jury trial occurred, a dis­ trict court ruled on whether these issues would survive summary judg­ ment.90 the district court initially found that the detective violated the muellers' procedural due process rights by failing to provide taige's parents with pre-:and post-deprivation notice before and after taking taige into custody.91 the court also found that the state officials "vio­ lated the muellers' rights by (1) failing to give post-deprivation notice to eric mueller, (2) communicating too broad a consent to treatment of taige mueller, and (3) holding taige too long after the imminent dan­ ger had abated. "92 the court retained the issue of whether or not taige was actually in "imminent danger" for trial, along with issues of wheth­ er taige's physician committed conspiracy when he exaggerated taige's condition to the detective in order to have taige removed from her mother's custody.93 the court's initial rulings suggested that it recognized a serious problem in taige's case. by finding that both the detective and the state officials violated the muellers' constitutional rights, the court was openly condemning the act of a physician calling in the authorities be­ cause of a disagreement over a medical course of action between moth­ er and physician. nevertheless, two important issues prevented a resounding success for the muellers in the early stages of their case. the first issue in­ volved qualified immunity.94 the district court initially held that the state officials and the detective were entitled to qualified immunity on all claims except the detective's preand post-deprivation notice claims, and the officials' post-deprivation claim. 95 the second issue involved an appeal by the detective to the 9th circuit court of ap88. press release, the center for individual rights, supra note 13. 89. see mueller ex rei. mueller, 2001 wl 627620, at *9-16. 90. id. at *26-27. 91. id at *26. 92. id. 93. id. 94. see generally scheuer v. rhodes, 416 u.s. 232 (1974) (explaining the judicially created doctrine of qualified immunity used to protect officers of the executive branch from liability on the basis that officials must be afforded some protection or they will never act). 95. see mueller ex rei. mueller, 2007 wl 627620, at *26. 2011] the cases of taige mueller and daniel hauser 211 peals.96 the court of appeals subsequently overruled the lower court's summary judgment against the detective, fmding that he was entitled to qualified immunity, and that the doctrine was created specifically for cases like taige's.97 soon after, the state filed a motion to reconsider the district court's summary judgment for eric mueller's notice claim.98 the district court agreed with the state and reversed the summary judgment in favor ofthe muellers' notice claim against the state.99 thus, the interpretation by the courts before the jury trial occurred is difficult to gauge. on one hand, the district court maintained there were genuine issues of fact regarding whether taige was in imminent danger, 100 meaning that a jury could have found that the mueller's pro­ cedural due process rights were violated when taige was removed from their care. on the other hand, qualified immunity may prevent the state from being liable. both the district court and the court of appeals seemed to recognize that the muellers have been wronged. ultimately, this case was decided by a jury in favor of the defendants, and not by a judge. tot while dicta in the circuit court's opinion suggest that what hap­ pened to the muellers is ''required by law based upon the need to allow government officials to make reasonable decisions,"102 a decision to override constitutional protections needs a legitimate reason, especially when it involves taking custody of a loving parent's child. protecting officers of the state from repercussions stemming from their duties may not be a good enough rationale. yet, the end result suggests that this may be a sufficient outcome, at least in the eyes of a jury. b. examining the hauser events daniel hauser's treatment decision was ultimately resolved after a judge ordered daniel to undergo chemotherapy.103 the events involving daniel hauser were different from that of taige mueller because of the ef­ fect the chosen medical care would have on each child. daniel's physi­ cians all agreed that he was unlikely to survive without chemotherapy, and that the prescribed treatment provided "a good chance of recov96. mueller v. auker, 576 f.3d 979 (9th cir. 2009). 97. /d. at 1000-1001. 98. mueller v. auker, no. cv-04-399-s-blw, 2009 wl 3806280 (d. idaho nov. 9, 2009). 99. /d. at *3. 100. see mueller ex rei. mueller, 2007 wl 627620, at *26. 101. press release, the center for individual rights, supra note 13. 102. mueller, 516 f.3d at 1000. 103. order, in re hauser, no. n -09-068, at 7 (minn. dist. ct. may 26, 2009), available at http:/lwww.mncourts.gov/documentsioipublic/other/hauser/order5.27 .09.pdf. 212 indiana health law review [vol. 8:199 ery."104 this immediately creates a large discrepancy, since the odds in taige's case were only five percent that she might have meningitis. 105 to properly fulfill its duty of parens patriae, the state must step in when the child's life is at risk, disregarding daniel's and his parents' wishes. seemingly, a child who faces certain death with treatment, and a high likelihood of survival with treatment, would demand state inter­ vention. c. medical testimony daniel's parents believed that an alternative treatment may have been more appropriate, and they actively sought holistic medicine after physicians administered daniel's first dose of chemotherapy. 106 thus, there were two competing rationales behind daniel's treatment: dan­ iel's parents' belief that holistic and alternative treatments were the best approach weighed against daniel's physicians' belief that chemothera­ py was the necessary treatment to save daniel's life. daniel and his parents were given the opportunity to participate in a court hearing during which daniel's physicians testified about these­ riousness of daniel's condition.107 at least one court has held that if medical evidence shows that prompt chemotherapy treatment is re­ quired, it would likely nullify any contrary evidence from a parent. 108 this approach seems sound in situations like daniel hauser's, be­ cause it gives the court the opportunity to weigh both approaches and choose the safest option for children like daniel. the court sided with daniel's physicians because of the weight our society lends to medical advice. daniel's parents were not physicians, and the state defers more to sound and tested evidence when comparing strictly medical evidence and testimony. while daniel's parents' opinion of proper treatment is important to their interest in caring for their child as they see fit, it does not nec­ essarily follow that their opinion will conform to the best medical ad­ vice. daniel's parents could have brought in a different medical expert their hearing. in fact, this would have been preferable, as it would have given the court an opportunity to see both sides of the medical evi­ dence. if all of the relevant interests are taken out of the analysis, and 104. id. at 5. 105. mueller, 576 f.3d at 983. l 06. see cooper & davis, supra note 10. 107. see findings of fact, conclusions of law, and order, in re hauser, no. n-09068, 2009 wl 1421504 (minn. dist. ct. may 14, 2009) (speculating daniel would be un­ likely to survive without treatment and estimating a success rate of treatment between eighty-five and ninety-five percent) (page numbers unavailable). 108. see in re d.g., 970 so. 2d 486, 490 (fla. dist. ct. app. 2007). 2011] the cases oft aige mueller and daniel hauser 213 these scenarios are viewed in a vacuum, it seems straightforward that the most reliable medical evidence could be used to make the decision. if one only compares medical evidence in these two instances, there is a stark contrast between the small risk taige mueller had of actually having meningitis and the low chance of survival for daniel hauser. a small risk calls into question whether the child is actually in danger. the district court in mueller stated that when "there is a close association between the risks of treatment and the risks of foregoing treatment ... it is now the grim duty of the parents to make the cal1!'109 on the other hand, when the discrepancy is much larger and the child's life is clearly at risk, the state should be able to override the parent's decision. 110 this reasoning suggests a couple of important points to consider. first, it shows that wide discrepancy in risk in these two instances still yielded the same result in both: forced medical treatment contrary to the parent's wishes. considering only the medical testimony from these two scenarios suggests that the court gives great weight to the physi­ cian's opinion. this may highlight more difficulties in scenarios like taige mueller's case, since the muellers alleged in the suit that taige's doctor might have exaggerated the danger in order to have taige taken away from her mother.u 1 another important point regarding medical testimony arises when parents have their own opinions or based on research. it is likely that in these scenarios, the parents' opinions or research will be largely dis­ counted by the state. corissa mueller testified that she conducted her own research regarding the likelihood of her daughter having meningi­ tis, and her opinion was that the odds were less than one percent. 112 in addition, corissa mueller tried to explain to the detective that the risk of treatment outweighed the risks of illness, explaining that her own research indicated that the spinal tap "could cause an infection from the needle puncturing the spine. that you can cause meningitis itself from that procedure. that it can cause paralysis, can cause brain damage or severe headaches. "113 this information ultimately was tossed aside in favor of taige' s physician's opinion. 109. mueller e.'< rei. mueller v. auker, no. cv-04-399-s-blw, 2007 wl 627620, *9 (d. idaho feb. 26, 2007); see also tenenbaum v. williams, 193 f.3d 581, 594 (2nd cir. 1999) (stating that possibility of harm to a minor child is not enough for the state to take a child into custody). 110. see custody of a minor, 379 n.e.2d 1053 (mass. 1978) (compelling child to un­ dergo chemotherapy against parents' objections, because treatment had minimal side effects and would likely save child from dying). 111. see mueller ex rei. mueller, 2007 wl 627620, at *25. 112. mueller v. auker, 576 f.3d 979, 983-84 (9th cir. 2009). 113. mueller ex rel. mueller, 2007 wl 627620, at *4 (referencing corissa mueller's deposition testimony). 214 indiana health law review [vol. 8:199 similarly, daniel hauser's parents bad their own opinions regard­ ing his treatment and were under the impression that his treatment could be secured through holistic forms, because his family belonged to the nemenhab band religion.114 the leader of the religion believed that daniel was entitled to his own choice in the matter.m in this respect, daniel's events differed from that of taige mueller. daniel's parents' concerns rested somewhat on religious ideals, whereas taige's mother based her opinion on research relating to spinal taps. when viewing only the medical testimony of the respective parties in daniel's case, without regard for any other interests, it seems logical to defer to trained medical professionals. while the court in the daniel hauser case came to the correct result, it must be noted that there are serious complications to chemotherapy treatment that both daniel and his parents feared! 16 in addition to the possible complications, there is also a potential fear that physicians may exaggerate their diagnosis in order to see that their opinion is followed. these two instances indicate that any opinion a parent may have regarding the medical certainty of proposed treatment will be supersed­ ed by the physician's opinion. this can occur regardless of whether the discrepancy is a four percent difference (corissa mueller believed her daughter had a one percent chance of having meningitis and the physi­ cian believed that risk to be five percent)117 or whatever the odds dan­ iel's parents believed their alternative treatments had of curing his cancer. nevertheless, the state's interest in protecting the well-being of taige mueller rested on only a five percent chance of the child being sick. the state's interest in protecting the well-being of daniel hauser was based on a high chance of his survival. compared together, these two results suggest that any chance of a child being sick may be enough to outweigh the parent's wishes. however, there is case law that sug­ gests when the risk from treatment is high enough, the court will defer 114. dean johnson, nemenhah band: no chemo, alternative health j. (may 15, 2009), http://www.altemativehealthjournal.com/article/nemenbah_band_no_chemo/2811; see also about us, nemenhah band, http://www.nemenhah.org/internal/about_us.html (discussing the basic history and mission of the nemenhah band of ''natural healers") (last visited jan. 3, 2011 ). 115. /d. ("the issue is danny's right to decide how he wants to live his life .... what if they make him take chemotherapy and he dies :from that? the band will mourn with the family if that's the case, but we'll rejoice that danny had the opportunity to test the law of the land"). 116. childhood hodgkin lymphoma treatment, nat'l cancer inst., http://www.meb.uni-bonn.delcancer.gov/cdr0000257999.html (detailing known risks such as problems with development of sexual organs, fertility problems, thyroid, heart, and long problems, increased risk of developing a secondary cancer, and bone growth problems). 117. mueller v. auker, 576 f.3d 979, 983-84 (9th cir. 2009). 2011] the cases of taige mueller and daniel hauser 215 to the parent's wishes.118 d. procedural complications perhaps the most glaring criticism of the way the taige mueller's case was handled is that her parents were never given the opportunity to be heard in a formal hearing. this procedural issue occurred chiefly because of the insistence by taige's physician that there simply was no time. 119 however, in daniel's case, both his parents and his physician were given the opportunity to testify in front of a judge. 120 because of this, any interest that taige's parents may have had in the care of their child was immediately overruled when the state became convinced that taige needed the spinal tap procedure. this creates a concern that the state's interest in the preservation oftaige's well-being was based sole­ ly on the opinion of one physician. taige's parents were not afforded the opportunity to have their side of the story heard; rather, a single physician determined the care of their child. it is possible that if given the opportunity, taige's parents could have found at least one physician who would have respected their decision. this is especially true since taige's family physician had consulted with corissa over the phone and advised her how to handle withholding consent from the spinal tap procedure. 121 generally, when the state takes a child into custody, parents have a right to a pre-deprivation hearing before they lose the custody of their child.122 in taige's case, this presumption was rebutted because the child was thought to be in imminent danger.123 the problem with this line of reasoning is that taige only had a five percent chance of being in imminent danger. 124 according to the ninth circuit court of ap­ peals, when the state believes that a child is in imminent danger, the state may compel treatment. 125 imminent danger should not be defined as a five percent risk of being sick. the reasoning behind the state's circumvention oftaige's parents' rights at the time was, thus, incorrect. 118. see newmark v. williams, 588 a.2d 1108 (del. 1991) (deciding that court would not order child with cancer to undergo radical form of treatment with a success rate of only 400/o ); but see custody of a minor, 393 n.e.2d 836 (mass. 1979). 119. mueller, 576 f.3d at 984. 120. see mother, son missing, supra note 34. 121. mueller, 516 f.3d at 983-84. 122. see id. at 995; stanley v.lllinois, 405 u.s. 645 (1972). 123. mueller, 516 f.3d at 984. 124. id at 983. 125. jd at 995 (quoting wallis v. spencer, 202f.3d 1126, 1138 (9th cir. 2000)) (not­ ing, "[w]hen the state has 'reasonable cause to believe that 1he child is in imminent danger of serious bodily injury and ... the scope of the intrusion is reasonably necessary to avert that specific injury,' a state has the authority without prior judicial authorization to compel a minor child to undergo specific medical treatment over parental objections."). 216 indiana health law review [vol. 8:199 in daniel's case, the court had time to weigh the situation and hear var­ ious testimonies, but in taige's case, the vehicle used to wrest away custody was simply an empty determination that taige was in imminent danger. if the state is going to accept that a five percent risk of illness as enough to overrule a parent's decision regarding medical treatment for the child, 126 then there is no point in even having an imminent danger exception. if so, then the state should immediately have the power to take away custody and decision making any time a parent and a physi­ cian disagree on treatment. the state has the burden of proving that interference in the child-parent relationship is necessary, 127 and that was simply not accomplished in mueller. this point further suggests that the taige mueller case was handled incorrectly. the counter-argument to this assessment is that the magnitude of harm to the child should also be considered. however, there is a point where the risk becomes so small that the magnitude of harm becomes inconsequential. for exam­ ple, driving taige to the hospital likely posed a risk of her becoming involved in a fatal car crash, but the risk was small enough that the de­ cision was still left to taige's mother. on the other hand, supporters of the decision in mueller would likely cite the urgency expressed by the physician. 128 because of the physician's pressure, the representatives of the state, who would ulti­ mately decide what would happen in taige's case, had no time to for­ mally hear both sides of the story. if this was true, it only further highlights the difficulties bound to occur in these situations. neverthe­ less, the removal of taige mueller from her mother and disregard of corissa mueller's wishes without any sort of formal hearing was incor­ rect. the procedural analysis of this case suggests that mueller may have been hastily and incorrectly decided. the state's interest in pro­ tecting the child could have been evaluated in terms of the risks and benefits of the spinal tap procedure had the physician not made the threat appear so immediate.129 this raises serious questions as to bow similar circumstances would have fared under judicial scrutiny in a court hearing. most likely the five percent chance of meningitis would have been weighed against the risk associated with the spinal tap proce126. see santosky v. kramer, 455 u.s. 745 (1982). 127. newmark v. williams, 588 a.2d 1108, 1110 (del. 1991) (noting, "although [the right to make important decisions for a child] is not absolute, the state has the burden of proving by clear and convincing evidence that intervening in the parent-child relationship is necessary to ensure the safety or health of the child."). 128. mueller, 516 f.3d at 984. 129. newmark, 588 a.2d at 1117 (stating, "[t]he linchpin in all cases discussing the 'best interests of a child', when a parent refuses to authorize medical care, is an evaluation of the risk of the procedure compared to its potential success.''). 2011] the cases oft aige mueller and daniel hauser 217 dure. 130 taige's parents were concerned enough about the risks from the procedure that they planned to not consent to the procedure before­ hand.131 had they been allowed to refuse, it is very likely that taige's parents would have found a medical practitioner who agreed with their assessment, or at the very least respected their wishes. this would have solved the problem of judicial deferral to medical testimony, as contra­ ry medical judgment would have been available. 132 when viewed through the lens of the events surrounding daniel hauser, it seems clear that a procedural hearing was required for a fair outcome. the judge in the hauser case made the right decision based on the evidence and found that the benefits of treating his cancer with chemotherapy outweighed the risks. both sides were given an oppor­ tunity to be heard, and the judge decided that daniel hauser should be given the treatment that posed a high likelihood of saving his life. 133 had taige mueller been given a hearing to decide if a five percent chance of sickness outweighed her parent's vehement objections to the treatment, it is probable that corissa mueller never would have lost cus­ tody of her child. e. did neglect mandate state intervention? as stated above, decisions regarding a child's care are left to the parent. 134 but, if the well-being of a child is at issue, the state may in­ tervene to protect the child. 135 the state's intervention may come from the doctrine of parens patriae. 136 the concept of parens patriae can be seen unfolding during the events surrounding daniel hauser. daniel's mother kidnapped him af­ ter the court ordered that he be treated using chemotherapy, and she fled the area with her son, forcing the court to act by authorizing police to find and detain daniel. 137 the court determined that daniel should 130. see custody of a minor, 393 n.e.2d 836 (mass. 1979). 131. mueller, 516 f.3d at 983. 132. see in re d.g., 970 so.2d 486, 490 (fla. dist. ct. app. 2007). 133. see findings of fact, conclusions of law, and order, in re hauser, no. jv-09068, 2009 wl 1421504 (minn. dist. ct. may 14, 2009) (page numbers unavailable). 134. see prince v. massachusetts, 321 u.s. 158, 166 (1944). 135. wisconsin v. yoder, 406 u.s. 205, 233-34 (1972) (holding, "the power of the parent ... may be subject to limitation ... if it appears that parental decisions will jeopardize the health or safety of the child .... "). 136. see, e.g., in red. g., 970 so.2d at 490 (noting, "parents' rights are not absolute, as the state has parens patriae authority to ensure that children receive reasonable medical treatment which is necessary for the preservation of life. and as between parent and child, the ultimate welfare of the child is the controlling factor."). 13 7. order to apprehend and detain, in re hauser, no. jv -09-068, at 5 (minn. dist. ct. may 19, 2009), available at http://www.rnncourts.gov/documents/o!public/other/hauser/ order_to_apprehend_and_detain.pdf (ordering police to apprehend and detain daniel hauser). 218 indiana health law review· (vol. 8:199 undergo chemotherapy, which his parents had purposefully chosen not to do, in hopes of pursuing alternative medicine. 138 the removal of daniel by his mother seemingly amounts to neglect on her part in the care of her child, and this appears to be the court's justification for eventually giving the hauser family an ·ultimatum: accept the live­ saving treatment or daniel will be removed into state custody. in taige's case, there is seemingly little to justify the parens patriae doctrine, unless the state assumes that the spinal tap was necessary to pre­ serve the life of the child. the physician's opinion was weighed by the officer in a pressure filled situation, not in a court with ample oppor­ tunity and weight given to each party. this suggests that even if there was enough evidence to invoke parens patriae,. it is unlikely that the officer weighed, or was even capable of weighing, the parents' interests in this situation. the district court in mueller stated· that, "when an of­ ficer encounters an emergency situation where a parent is refusing medical treatment for her child, the officer's threshold. task is to determine whether there is time and means to contact a judge."139 the court's opinion only further suggests that officers in this type of scenario are unfit to adequately balance the interests involved. f. policy arguments from a public policy perspective, mueller and hauser events serve as distinct examples of what is "right" with state intervention in a child • s health care, and what is "wrong." the hauser events show why the state must intervene. the state must not only protect its own inter­ ests in the well-being of the child, but also it must make sure that chil­ dren like daniel do not die because of their parent's decision. 140 instead, daniel's case shows that when the state intervenes, children's lives can be saved, as daniel's cancer seems to be in remission because of the state's interference. 141 on the other hand, mueller shows the pitfalls that can occur when the state is rushed into making a decision. corissa mueller had her child taken away from her, was forced to sit by while a procedure she feared and expressly rejected was performed on her daughter, and was not given any formal chance to have her opinions heard. 142 138. see judge rules family can't refuse chemo, supra note 65. 139. mueller et rei. mueller v. auker, no. cv-04-399-s-blw, 2007 wl 627620, •10 (d. idaho feb. 26, 2007). 140. see prince v. massachusetts, 321 u.s. 158, 170 (1944) (noting, "parents may be :free to become martyrs themselves. but it does not follow they are :free, in identical circum­ stances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves."). 141. see wasserman, supra note 43. 142. mueller v. auker, 576 f.3d 979, 983-86 (9th cir. 2009). 2011] the cases oft aige mueller and daniel hauser 219 i. protecting the child the events surrounding daniel ha1,1ser prove that state interven­ tion can save lives in these scenarios. without court intervention, dan­ iel would likely have died. unfortunately, cases like this do occur and are timely in this discussion. 143 as between any other concerns and the welt-being of a sick child, the state should side with whatever option will best safeguard that child's health. 144 for daniel hauser, the decision seems clear based on the outcome predicted by his physician. 145 in cases like daniel's, where the state has ample time to weigh the evidence for multiple courses of treatment, the state can safely decide what is best for the child. more difficult cases arise when scenarios like taige mueller's are presented where a deci­ sion must be made quickly. in taige's case, the state decided that a five percent risk warranted depriving a parent of the custody of her child and forcing unwanted medical treatment. 146 however, based on the assessment of the risk, that decision should have required further inquiry. there are undoubt­ edly numerous dangers an infant will face as they mature, and it is like­ ly that many of those risks will have a greater than five percent chance of occurring. however, unless the danger involves neglect, or in taige's case a medical decision, it is unlikely that the state will ever be involved. to base such a difficult and emotional decision solely on a five percent chance of an event occurring cannot be the best possible solution. it is no surprise that the court in mueller acknowledged that what happened was both difficult and undesired. 147 in cases like taige mueller's, it is sound public policy that decisions that effectively strip away a parent's ability to care for his or her child be based upon more than a five percent risk. there is also a policy argument against forcing unwanted health care when there may be potentially devastating side effects. 148 corissa mueller was adamant that the spinal tap procedure had a chance of causing infection, paralysis, or brain damage. 149 the risks of side ef143. dirk johnson, trials for parents who chose faith over medicine, ny times, jan. 20, 2009, http://www.nytimes.com/2009/0l/21/us/21faith.html (discussing the story of a wisconsin eleven-year-old girl who died because her parents believed that god alone could heal her illness, and did not seek out medical treatment). 144. in re d.g., 970 so.2d 486, 490 (fla. dist. ct. app. 2007) ("and as between parent and child, the ultimate welfare of the child is the controlling factor."). 145. see findings of fact, conclusions of law, and order, in re hauser, no. n-09068, 2009 wl 1421504 (minn. dist. ct. may 14, 2009) (page numbers unavailable). 146. mueller, 516 f.3d at 979,984. 147. id. at 1000. 148. childhood hodgkin lymphoma treatment, supra note 116. 149. mueller ex rei. mueller v. auker, no. cv-04-399-s-blw, 2007 wl 627620, *4 (d. idaho feb. 26, 2007) (referencing corissa mueller's deposition testimony). 220 indiana realm law review [vol. 8:199 fects for medical treatment are usually something that is accepted in return for the possibility of the treatment being effective. however, when the treatment is unwanted, side effects become an independent risk that the state has decided the child must undertake. if either taige or daniel had experienced a severe side effect from their treatment, there would likely have been even more intense judicial scrutiny. it is important to acknowledge that w~en the state forces medical treatment with side effects on a child, there is always a potential that the unwant­ ed treatment may actually do more harm than good. 2. parental autonomy whether or not daniel's parents were justified in seeking alterna­ tive treatment, the fact that they were allowed to continue caring for him after his mother effectively kidnapped him shows they were con­ sidered fit parents.150 it is important to note that daniel's parents seemed to disagree with the treatment,151 were likely fearful of the side effects, and had chosen an alternative form of treating daniel's cancer. when viewed from only a public policy perspective, the parental autonomy of a family should be held very high. parents are given much leeway to raise their children, and it is in society's best interest that lov­ ing families be kept together. parents maintain autonomy over select­ ing where their child will live, what they eat, when they go to bed, how much television they watch, nearly every aspect of their child's life, until that child becomes old enough to make decisions on their own.152 nevertheless, the principle of parental autonomy is in direct con­ trast with what happened in the cases of daniel hauser and taige mueller. in most cases that do not involve neglect, it is in society's best interest to restrict the state's interference in the parent-child rela­ tionship. the courts have recognized this principle of restricting the state's interference.153 however, in cases that concern the child's safe­ ty, parental autonomy should be cast aside if the risk of refusing the medical care greatly outweighs the risk associated with the child being treated. in daniel's case, the risk of refusing medical care was evident and was adamantly supported by the medical opinions of his physi­ cian.154 in a case like daniel's, where a child's health is in serious 150. see cooper & davis, supra note 10. 151. see mother, son missing, supra note 34 (discussing letter from daniel's parents stating that they "believe that the injection of chemotherapy into danny hauser amounts to an assault upon his body, and torture when it occurs over a long period of time."). 152. prince v. massachusetts, 321 u.s. 158, 166 (1944). 153. see santosky v. kramer, 455 u.s. 745 (1982). 154. see findings of fact, conclusions of law, and order, in re hauser, no. jv-09068, 2009 wl 1421504 (minn. dist. ct. may 14, 2009) (page numbers unavailable). 2011] the cases of taige mueller and daniel hauser 221 jeopardy and there is a clear discrepancy between the ramifications of the parent's decision and the effect prescribed treatment will likely have, the state should defer to the expertise of physicians if they are in the child's best interest.155 in a case such as taige mueller's however, the answer becomes less clear, and the analysis must adapt accordingly. a case like taige's does not involve the same level of risk to the child when medical treat­ ment is refused, and it is arguable that the risk to her well-being was minimal.156 in these scenarios, the opinions and wishes of the parents should be given weight when the state is . evaluating whether or not medical treatment must be given to secure the well-being of the child. if society is to embrace the assumption that most parents will act in the best interests of their children, 157 then the state must give weight to a parent's wishes when the risk to the well-being of the child is not sig­ nificant. 3. the physician's role the physicians in the mueller and hauser case had an intimate role in how these cases were resolved. physicians are charged with car­ ing for their patients. in daniel's case, this meant recommending a form of treatment with known side effects!58 in taige's case, this meant involving authorities who were forced to restrain a loving parent. from a policy perspective, we want physicians to care about their pa­ tient's well-being. it would be counterintuitive to hamper physicians in doing what they believe is best for their patients, especially when it comes to children who are, by law, incapable of giving medical con­ sent.159 in both of these cases, the physicians believed the treatment they prescribed was in the child's best interest. our society places im­ mense trust in physicians, and this trust results from the years of train­ ing and education physicians must undergo before they are allowed to work as medically trained professionals. as much research as taige's mother had done on the issue of spi­ nal taps on infants, it no doubt paled in comparison to the emergency room physician's knowledge of the subject. as a society, we do not want laymen making crucial life or death medical decisions. it is a 155. but see newmark v. williams, 588 a.2d 1108 (del. 1991) (deciding that court would not order child with cancer to undergo radical form of treatment with a success rate of only forty percent). 155. see prince, 321 u.s. at 166. 156. mueller v. auker, 576 f.3d 979 (9th cir. 2009). 157. see generally jacobs, supra note 47 at§ 10:3. 158. childhood hodgkin lymphoma treatment, supra note 109. 159. seegenerallyjacobs,supranote41 at§ 10:3. 222 indiana health law review [vol. 8:199 physician's job to make informed medical decisions in high-pressure situations. this is precisely why expert medical testimony is generally given more weight compared to a p~ent's perspective on a course of treatment.160 finally, it is more likely that a physician will err on the side of caution when recommending a course of treatment. with the threat of malpractice suits, it is only natural for a physician to be overly cau­ tious in most situations. since medical testimony in these cases is heavily weighed, a physician may inadvertently affect the interests of the parent, simply by being safe in their recommended treatment. again, we want physicians to do what is best for their patients, but un­ fortunately at times, this may mean interfering with a parent's right to care for her child without interference from the state. these decisions are difficult to make, especially in cases where time may be limited, and decisions need to be made quickly. 4. state actors charged with deciding what to do in difficult situations the state social worker in mueller had few options.161 a trained medical professional told her that a sick child needed a standard proce­ dure, and that the window to do the procedure and treat the illness would close in less than three hours.162 from a policy perspective, any state actor placed in a similar situation does not have the ability to properly weigh the interests of the parent against the interests of the state in protecting the child. the state worker does not have the time or the legal or medical knowledge to properly assess the situation. this creates difficult scenarios like in mueller where an official had to make a quick decision that they may not be adequately trained to make. these cases also present difficult decisions for judges. the judge in daniel hauser's case issued a detainment order to force a child to undergo a treatment that had already made him sick, a treatment that his parents disagreed with.163 likewise, if taige mueller had been given a hearing, a judge would have been forced to weigh the opinions of a concerned medical professional against the concerns of a loving and terrified mother. in reality, the time-sensitive nature of future cases that might resemble that of taige mueller are never going to provide enough time for a full hearing. this likely means that state actors will 160. see in re d.g., 970 so.2d486 (fla. dist. ct. app. 2007). 161. mueller, 516 f .3d at 984. 162. id 163. order to apprehend and detain. in re hauser, no. n -09-068, at 5 (minn. dist. ct. may 19, 2009), available at bttp:/lwww.mncourts.gov/documents/o/public/other/hauser /order_ to_ apprehend_ and_ detain.pdf. 2011] the cases of taige mueller and daniel hauser 223 be forced to decide these extremely complicated issues with little time to consider all of the interests involved. 164 5. the state (legislature) the state must maintain and protect its interest in the child. it cannot do this by bowing to every parent who does not agree with his or her physician's treatment plan. if the state sides with the parent and disregards the physician, the consequences can be dire. thus, for a leg­ islature to pose any sort of solution, it must be cognizant of the fact that certain parents will fail to choose the correct course of treatment for their sick child, possibly resulting in the child's death. in daniel's case, it is obvious that the state made the right decision and saved a child's life. on the other hand, in mueller, the state de­ prived a well-informed family of the custody of their child and submit­ ted the child to unwanted medical care. g. possible solution to a complicated problem the problems highlighted by mueller and daniel hauser's case is that there are competing interests among the parties involved, and all parties believe they are making the best decision. the parents want to be able to care for their child free from interference, but the state must interfere if it believes the parents' decision creates enough risk to the child's life tore­ quire intervention. physicians and state actors such as police and social workers further complicate the problem. both of these characters may be highly experi­ enced in their particular fields, but they are unlikely to have the necessary understanding to adequately balance the legal interests at issue between· parent and state. practically though, they are the ones who ultimately make the decisions. cases like daniel hauser's provide an adequate solution to the problem by bringing the dispute to the courtroom. in court, a judge pan properly weigh the competing interests and come to a decision based on the particular factual scenario. this prevents state actors from making snap decisions that may infringe on the constitutional rights of parents. when these types of cases are taken inside a courtroom, a judge can properly assess the risk of a child not having a treatment and weigh it 164. see generally mathews v. eldridge, 424 u.s. 319, (1976) (discussing the factors that will be weighed when determining whether a pre-deprivation, evidentiary hearing was needed. the court weighed the individual's interest at stake, the reliability of the current procedures in place and whether additional safeguards (like a trial) would have any effect, and the court weighed the costs and administrative burden that would arise from allowing such a hearing. in this case, the court found that no pre-deprivation hearing was required for the termination of social security benefits). 224 indiana heal1h law review [vol. 8:199 against the parents' wishes and any dangers that may be associated with the treatment. if the risks of treatment are close to the risk of not treating in the recommended manner, the parents should be allowed to make the choice.165 if the risk of not treating outweighs the parents' interests and the danger of treatment, then the judge should order the treatment.166 amidst this analy­ sis, the judge can also weigh the side effects of the treatment on the child, the chance of successful treatment, and survival rate of the procedure. requiring more formal procedural due process works for multiple rea­ sons. first, it allows the parents to actually be heard. daniel hauser's par­ ents were given a hearing, and they were able to convey to the judge their own beliefs on how daniel should be treated.167 the court was then given the opportunity to weigh those beliefs against the risks daniel faced and, thus, was able to come to a properly reasoned conclusion. requiring a hearing also takes the burden off of the state. state actors are generally not equipped to make these kinds of decisions. they likely do not have the training or expertise to properly balance constitutional interests and medical risk. they also may lack the medical knowledge to make any sort of assessment involving the necessity of medical treatment. this high­ lights the greatest problem with the approach taken in mueller. the person who made the ultimate decision as to whether the infant would receive a spinal tap against her parent's wishes had no medical expertise and was not capable of weighing the parent's interest. the state actor was simply caught in the middle of a dispute, trying to listen to complicated medical opinions and assess the wishes of an angry parent. this is not a job for a police officer or a cps worker. it should instead fall to a trained judge whose day-to-day business is applying the principles according to the law and weighing the interests of opposing parties. thus, the state actor's role in these scenarios will be greatly reduced, and they will come into the situa­ tion only after a judge has heard both sides and made a ruling. a formal hearing also takes pressure off physicians. when physicians and parents disagree over a child's medical care, it creates a hostile situa­ tion and will likely lead to a lawsuit.168 by allowing physicians to make their case in a courtroom, it takes away the confrontational aspect of having to disagree with a parent while emotions are high. this also allows the par­ ent of the child to seek a second medical opinion and have both sides of 165. mueller ex rei. mueller v. auker, no. cv-04-399-s-blw, 2007 wl 627620, *9 (d. idaho feb. 26, 2007) (noting, "[when] there is a close association between the risks of treatment and the risks of foregoing treatment ... [i]t is now the grim duty of the parents to make the call."). 166. see custody of a minor, 393 n.e.2d 836 (mass. 1979). 167. see findings of fact, conclusions of law, and order, in re hauser, no. n-09068, 2009 wl 1421504 (minn. dist. ct. may 14, 2009) (page nwnbers unavailable). 168. see, e.g., mueller ex rei. mueller, 2007 wl 627620, at *15-26 (mueller's case with the parents suing not only the physician, but also nearly every other person and entity that was involved with making the decision to treat taige. ). 2011] the cases of taige mueller and daniel hauser 225 medical testimony put in front of an impartial decision maker. physicians may carry exponential weight in influencing treatment decisions; therefore, it is even more important that the medical testimony be carefully scruti­ nized. there is also the fear that a physician might be exaggerating his diag­ nosis in an attempt to get the parents and state actors to consent to the treatment, which was alleged in mueller.169 a hearing can allow physicians to explain their concerns about the treatment or procedure and can allow for differing opinions that may provide effective alternatives to be heard. the goal is that there is a chance for the parents to present their side of the story, as opposed to letting the physician's opinions completely control the situa­ tion. requiring a hearing before the state orders medical treatment for a child against a parent's wishes accomplishes multiple things: it allows par­ ents to state their wishes for caring for the child; takes pressure off of state actors who otherwise could be forced to make a snap decision they are un­ qualified to make; and it lessens the chance of serious confrontation be­ tween physicians and parents. a hearing instead offers an effective outlet to voice opposing viewpoints with the potential for alternative medical ap­ proaches. a judge overseeing a hearing on this type of issue can weigh the evidence on each side and determine whether the parents should be left to care for their child, or if the state should step in and order the child to un­ dergo treatment. in addition, if physicians are aware of this process, they may be more likely to involve the court system when the decision to be made is a close one. this could, in turn, protect the well-being of children in cases where the physician deferred to the parent's wishes and should not have. it also means that parents will be given a chance to be heard, if their physician dis­ agrees with them enough to involve the state. one obvious criticism to this approach is implementing it in a time­ sensitive situation like taige mueller's. taige's physician believed that a decision had to be made in three hours.170 this is a legitimate logistic-orientated concern. these concerns do arise in the real world, as evidenced by the detective in the mueller scenario explaining that he chose not to involve a judge because he thought it would take too long to receive a response in the short time frame taige's physician had laid out.171 this problem highlights a pragmatic roadblock, but the unique nature of these scenarios demand a proper solution. the deprivation of the ability to choose how to care for one's child is different from the loss of a property interest or infringement of a right, simply for the fact that it 169. /d. 170. mueller v. auker, 576 f.3d 979, 984 (9th cir. 2009). 171. mueller ex rei. mueller, 2007 wl 627620, at *5. 226 indiana health law review [vol. 8:199 has the potential to end disastrously because of the nature of medical care, and how many things can go wrong in an emergency room.· in situations like these, emotions may be running high between physician, parent, social worker, and officer, and the only way to resolve a proper outcome is to al­ low a neutral party, properly informed of the distinct interests at stake, hear the evidence and make a decision. if time is at issue, then it becomes even more important that access to this process be immediate, so as to avoid situ­ ations like taige's, where an officer does not even bother to involve the court because he is worried about response time. the best possible solution in these time-sensitive cases would be to have an informal hearing done by someone with expertise to make deci­ sions, similar to an administrative law judge ("au"). the crux of the solu­ tion will depend on the promptness and availability of the arbiter. when parent and physician disagree, the au could conduct an informal hearing­ even over the phone if need be, but, this hearing needs to be immediate. this entity would need to be directly linked to social services so that the agency could respond when physicians felt the need to involve the state. the process would need to be informal because of possible time re­ straints. however, this does not mean that an informal reviewing entity could not take the time to properly weigh all the competing interests. the informal hearing would need to be conducted at the same time the state de­ termines that there is not enough time for a formal hearing. the person in this position would need to be on call during set times, and capable of hear­ ing disputes over medical care involving parents and physicians. as tech­ nology continues to progress, it seems likely that video conferencing could become a viable option for these individuals to hear relevant disputes, which will could allow for a more complete impromptu hearing. additional criticisms revolve around costs and resource availability. if a new system premised on immediacy is implemented, it will require constant staffing by those approved to properly weigh the issues and make a decision. the most logical candidates would be judges, but they are ex­ tremely limited in number, and it may be too far-fetched to expect judges to be available at all times in order to settle these issues if they should arise and require immediate attention. another option would be to train state social workers for these particu­ lar situations. this would require an intense focus on understanding the law, a commitment on top of ordinary job duties, and would need funding to come from somewhere. on top of increased costs, social workers are unlikely to ever have the same understanding of the legal interests at stake, when compared with judges. an increase in costs is all but given should the solution focus on being able to react promptly, and this simply cannot be avoided. costs could be somewhat deferred if the parents were asked to pay some of the costs, should they chose to invoke the system, much in the same way court fees are imposed when a person files suit. 2011] the cases oft aige mueller and daniel hauser 227 preferably, judges would be the only arbiters of these decisions. the increased commitment would likely be tempered by the rarity of cases oc­ curring that required immediate attention. those that would arise are likely important enough decisions that society should desire a neutral decision­ making outlet. while implementing a new system focused on immediacy and availa­ bility of judges to hear these disputes is going to be difficult, there are two important policy implications to focus on. first, a case like that of taige mueller's must be given a proper forum in which to be heard. the legal rights of the parents involved and the possible consequences to the child's health are far too important to be made by ill-equipped state actors. se­ cond, it is unlikely that cases as time sensitive as taige mueller's will occur frequently. ultimately, society would rather have a judge at an impromptu hearing make this decision instead of a frazzled police officer or social worker listening only to the physician yelling in his ear. a second important criticism involves the administrative burden this solution would create. most courts already handle a heavy caseload, and this would only be increased by additional hearings of this type. the im­ portance of these types of cases must not be overlooked simply because the courts are busy. a parent's right to care for her child is constitutionally protected.172 if this right is to be taken away, the parent must have a chance to be heard. if the only way to give parents a chance to be heard when the life of their child is at stake is to appoint special judicial positions to hear these cases, then the legislature should be relied upon to do just that. iv. conclusion the interests at stake when considering unwanted medical treat­ ment for children are extremely important. as was discussed in the case of daniel hauser, an incorrect decision on the part of a state actor could be fatal to a child whose parents choose not to follow the physi­ cian's orders. in those cases, the state is justified in stepping in, despite the wishes of the parents. when the welfare of the child is at a severe risk without medical care, the state must become involved. on the other hand, there is a significant interest that parents have in raising and caring for their children without unwanted interference from the state. in mueller, the state made a rushed decision that de­ prived corissa mueller of her daughter, and forced her to sit by and wait for her child to undergo a medical procedure she had refused. in that case, the state should have weighed other factors. in cases like the­ se, where the risk to the child's well-being is small, other concerns should come into play before the state forces a child to undergo treat172. see wallis v. spencer, 202 f .3d 1126 (9th cir. 2000). 228 indiana health law review [vol. 8:199 ment. these situations should not be decided based on yelling matches between physicians and parents. if a system were put in place where judges could immediately be contacted, parents would be given a chance to be heard before medical care was forced upon their child. if evidence was presented in each scenario from both sides under a uni­ form federal standard, parents would at least be given some say in the child's medical care when they disagree with the child's physicians. in the end, the judge could make a rational decision based on the parent's role and the physician's concern over treatment. even if the decision needs to be made immediately, a judge hearing both sides in an im­ promptu telephone conference is a better option than asking a police officer to make a rash decision. the criticisms to this approach would focus on the costs and ad­ ministrative burdens on a court system that is already stretched thin. while this is a real concern, it should not be enough to deter a state from implementing a process that would adequately protect both its in­ terests and those of the parent. ultimately, this solution gives parents a chance to be heard. this process will allow an experienced judge, to weigh the evidence and make a better decision then a police officer or untrained social worker is capable of. do the benefits outweigh the risks? the legal, business, and etmcal ramifications of pulling a blockbuster drug off the market neil f. hazaray• table of contents i. introduction ............................................................................... 116 ii. pharmaceutical industry statistics and the blockbuster drug •.....••••.••••••..•••••....•••.••••••..••••••...•...•....•••. 117 a. the blockbuster drug .....•.....................•......•........................... 117 b. the drug withdrawal .............................................................. 118 c. the pharmaceutical industry ................................................... 118 1. ongoing debate between pharmaceutical industry proponents and its critics ................................... 119 2. the pharmaceutical industry's reliance on the blockbuster drug .................................................... 120 3. the evolving and future role of the pharmaceutical industry ................................................... 121 iii. fda drug approval process .................................................... 122 iv. legal ramifications of pulling a drug off the market ................................................................. 125 a. vioxx lawsuits: the case against merck ................................ 126 b. criminal indictments and substantial financial penalties .................................................................. 130 v. business ramifications of pulling a drug off the market ........................................................................... 132 vi. etincal considerations of pulling a drug off the market ........................................................................... 135 a. ethical considerations faced by the pharmaceutical company before and after drug withdrawal ............................................................. 136 b. a blockbuster drug's withdrawal may affect those patients who have not reacted negatively to the drug ................................................ 139 c. balancing ethical considerations with the company's stated goal of profitability ................................... 141 vii. considerations of culpability in pulling a drug off the market .............................................................. 141 a. to what extent is the pharmaceutical company at fault? ................................................................... 142 b. to what extent is the fda at fault? ....................................... 143 116 indiana health law review [vol. 4:115 c. to what extent is the health care professional at fault? .............................................................. 144 d. shared culpability among all parties involved? .................... 145 viii. possmle solutions ....................... ; ............................................. 145 a. allow the withdrawn drug to reenter the market under restricted conditions ........................................ l46 b. create medical liability review panels in order to reduce the number of frivolous lawsuits ................ 147 c. create an independent drug monitoring board ...................... 14 7 ix. conclusion ................................................................................... l48 i. in1roduction the pharmaceutical industry has played an important role throughout world history. this industry is responsible for developing, manufacturing, and distributing lifesaving and sustaining medicines. today, due to medicines de­ veloped by the pharmaceutical industry, human beings are living healthier and longer lives. like most industries, however, the pharmaceutical industry has also been plagued with problems in recent years. presently, more drugs are being pulled off the market than ever before because of safety concerns. this has been followed by a wave oflawsuits aimed at correcting the error of allow­ ing such drugs on the market in the first place. as a result, the pharmaceutical industry has faced increasing amounts of negative publicity and a lack of confi­ dence from investors and consumers alike. in the united states, most pharmaceutical companies promote the dual ob­ jective of providing health care to the general public while making a profit for their shareholders. this is often a contentious proposition because companies will place a greater priority on achieving the latter rather than the former. moreover, the irony of this dual objective is that most large pharmaceutical conglomerates, such as merck, pfizer, and glaxosmithkline, are publicly traded companies.' pharmaceutical companies aim to maximize wealth for their stakeholders (shareholders in the case of a publicly held corporation and owners in the case of a closely held corporation). therefore, in order to do so, * j.d. candidate, 2007, indiana university school of law, indianapolis, indiana; m.b.a. candidate, 2007, indiana university kelley school of business, indianapolis, indiana; b.s., 2002, indiana university, bloomington, indiana. i would especially like to express my gratitude to my mother, father, and siblings, sean and sasha, for their lifelong encouragement and support. i would also like to thank rachel for all her love, guidance, and support. in addi­ tion, i would like to thank david jose for the helpful suggestions and invaluable insight he pro­ vided me as i wrote this note. 1 see generally yahoo! finance home page, http://finance.yahoo.com (last visited feb. 15, 2007). merck, glaxosmithkline, and pfizer stock are traded on the new york stock ex­ change. /d. 2007] pulling a blockbuster drug off the market 117 the objective of every major pharmaceutical company is to produce a block­ buster drug. because of the relative importance of producing a blockbuster drug, a withdrawal from the market of this drug can have severe consequences for the respective pharmaceutical company. subsequently, questions arise as to whether the lure of profit blinded the company into developing a potentially unsafe drug. in answering this question, it is important to examine the legal, business, and ethical ramifications for all parties involved: pharmaceutical companies, federal regulatory agencies, and patients who use the drugs. this note will discuss the significant ramifications of withdrawing a blockbuster drug from the market and how such a decision may impact particu­ lar persons or entities. part ii will define a blockbuster drug and a subsequent withdrawal from the market. in addition, it will examine the recent growth and role of the pharmaceutical industry in the development of novel blockbuster drugs. part iii will examine the drug approval process in the united states, specifically the steps involved in obtaining food and drug administration ("fda") approval for a pharmaceutical drug owned by a pharmaceutical com­ pany. part iv will analyze the legal ramifications of withdrawing a drug from the market, discussing recent court decisions involving baycol and vioxx. part v will examine the business effects of such a decision, specifically focusing on how such a decision affects the pharmaceutical industry and the respective pharmaceutical company that is forced to make such a decision. part vi will examine the ethical considerations that a pharmaceutical company must under­ take before making the decision to withdraw a drug from the market. finally, part vii and viii will examine those parties who may be particularly blame­ worthy in this saga and identify what, if any, potential solutions exist. ii. pharmaceutical industry statistics and the blockbuster drug the pharmaceutical industry is an ever-growing industry in the u.s. in large part due to the profitability of the blockbuster drug. because of the syn­ ergistic effect that both the pharmaceutical industry and blockbuster drug have on each other, it is important to define a blockbuster drug and its withdrawal from the market. it is equally important to examine the relative importance of the pharmaceutical industry in the united states and its effect on the develop­ ment and manufacturing of blockbuster drugs. a. the blockbuster drog for the purposes of this note, a blockbuster drug is a medicine that gener­ ates more than one billion dollars in sales in a year.2 in 2003, the world phar2 visionga1n intewgence, blockbuster drugs: a current assessment and 118 indiana heal til law review [vol. 4:115 maceutical market consisted of sixty-seven drugs, which together, generated over $136 billion.3 between 2004 and 2009, experts believe that at least twenty-four new blockbuster drugs will emerge, resulting in a total ofninety­ three.4 the current leading blockbuster drug in tenns of total sales is lipitor, which is owned and licensed by pfizer. for the second quarter of2006, lipitor contributed to pfizer a reported profit of$2.86 billion. 5 in addition, blockbuster drugs are heavily marketed by their respective companies to both patients and health care professionals alike. for instance, as of2005, pfizer has spent a total of$16.99 billion on marketing and administration expenses for lipitor since its inception in the u.s. market. 6 as a result of this heavy marketing, blockbuster drugs such as lipitor have become well known by the general public. in sum, blockbuster drugs are generally heavily marketed brands that provide patients with the efficacy that cannot usually be provided by generic and arguably less efficacious brands. b. the drug withdrawal a blockbuster drug withdrawal from the market can be devastating to the respective pharmaceutical company, the patients who use the drug, and the regulatory agencies. a drug withdrawal is either mandated by the fda (also known as an involuntary withdrawal) or proactively pursued by the drug's pharmaceutical company (also known as a voluntary withdrawal). in the past, there have been instances of both voluntary and involuntary withdrawals. it is important to note, however, that neither a voluntary withdrawal nor a fda mandated involuntary withdrawal presupposes any innocence or guilt on the part of the pharmaceutical company. nevertheless, as will be discussed later in this note7, a voluntary withdrawal can have much greater consequences in tenns of investor relations and public confidence for the respective pharmaceu­ tical company than an involuntary withdrawal. c. the pharmaceutical industry the pharmaceutical industry's relative importance in the united states is immense. from 2003 to 2004, total sales of prescription drugs increased by outlook for creating fulurebi..ockbusters (2004), http://www.visiongainintelligence.com /reportdetail.aspx?reportld= 1 088&adselection=y &industryldll =-1. 3 id. 4 id. 5 juliann walsh & nicole ostrow, pfizer earns $2.86 bin on lipitor sales; merck's profit slips, bloomberg.com, july 21, 2004, http://quote.bloomberg.com/apps/news? pid=l 0000 1 03&sid=al u3vuxkojwe&refer=us. 6 the "got cholesterol?" award: foroverpromotingexpensivebrand-namestatins, biti'erpll.lawards.org, apr. 26, 2006, http://www.bitterpillawards.org/crestor-liptor.php. 7 see infra part v. 2007] pulling a blockbuster drug off the market 119 8.3%. 8 not surprisingly, every year more and more new prescriptions are being written. for instance, the top twenty pharmaceutical corporations and their re­ spective medicines accounted for approximately $2.5 billion dispensed pre­ scriptions.9 in addition, the pharmaceutical industry netted a total of $235 billion in industry sales in 2004, which was nearly nineteen billion dollars more than the previous year.10 the desire to obtain a "piece of this pie" is motivating pharmaceutical companies to spend more in research and development than ever before. 11 in correlation with an increase in research and development ex­ penditures by pharmaceutical companies, retail spending on prescription drugs has increased significantly. as a result, "pharmaceuticals accounted for nearly one in every ten dollars spent on health care," a number that is projected to rise to nearly fourteen percent of all health care costs by 2010.12 1. ongoing debate between pharmaceutical industry proponents and its critics proponents of the pharmaceutical industry claim that the industry is sim­ ply supplying the market demand for its goods. critics, however, point to the fact that there are several competing drugs in each category and question why the industry produces so many duplicates, rather than focusing on the develop­ ment of novel medicines.13 critics, including many consumer advocacy and watchdog groups, point to classes of drugs such as statins, as the problem.14 8 2004 year-end u.s. prescription and sales information and commentary, imshealtilcom, feb. 22, 2006, http://www.imshealth.com/ims/portallfront/articlec/0,2777, 6599 _ 3665 _ 69890098,00.html [hereinafter 2004 year-end]. 9 imshealth.com, leading 20 corporations by total u.s. dispensed prescriptions, 2005, bttp://www.imshealth.com/ims/portal/front/articlec/0,2777,6599 _73914140_77266121, oo.btml. 10 2004 year-end, supra note 8. the net total of$235 billion was calculated by adding the following: chain stores, mail services, independent non-federal facilities. clinics, food stores, long-term care, federal facilities, home health, hmo, and other categories. ld. 11 id. in 2005, the biopharmaceutical industry spent a total of$51.3 billion in research and development. pharmaceutical research and ma:nufactijrers of america, pharmaceutical industry profile 2006 10 (2006) [hereinafter pharmaceutical industry profile 2006). 12 merr1u. goozner, the $800 mn.lion pill: the truth behind the cost of new drugs 232 (2004). 13 drugs are often categorized by the disease-state that they attempt to treat. 14 omudbome ogbru, statins, http://www.medicinenet.com/statins/article.htm (last vis­ ited feb. 15, 2007). '"statins' are a class of drugs that lowers the level of cholesterol in the blood by reducing the production of cholesterol by the liver. statins block the enzyme in the liver that is responsible for making cholesterol. •.. statins are used for preventing and treating atherosclerosis that causes chest pain, heart attacks, strokes, and intermittent claudication in individuals who have or are at risk for atherosclerosis." id. the most popular statins include lipitor, zocor and pravachol, which are also three of the highest selling drugs within the phar­ maceutical industry. 2004 year-end, supra note 8. the statio class of drugs currently accounts 120 indiana health law review [vol. 4:115 industry critics believe that the lure of profits and the subsequent investor per­ ception has led companies to produce drugs that increase revenues rather than those that benefit the general public by treating an incurable or untreatable dis­ ease.15 why else would there be a number of drugs in the same class that per­ form virtually the same function?16 in response, many proponents of the pharmaceutical industry rebut such a argument by claiming that each drug in a category, although created to treat the same disease-state, often has a different mechanism of action and as a result is in fact a novel drug.17 the practical answer, however, is that each drug makes a lot of money.18 as blockbuster drugs, these drugs can single-handedly reverse the fortunes of any dwindling pharmaceutical company. in other cases they may further enhance the profitability at a successful phannaceutical conglomer­ ate, certainly increasing its worth on wall street. 2. the pharmaceutical industry's reliance on the blockbuster drug blockbuster drugs account for a large percentage of the total net sales pro­ duced by the pharmaceutical industry. these drugs dominate the market be­ cause of their relative popularity and overall efficacy and safety. 19 in 2004, the top ten blockbuster drugs accounted for nearly thirty-eight billion dollars of total sales. 20 in 2004, for example, the top ten selling drugs in the united states made more than two billion dollars in sales each for their respective companies with the leader being pfizer's statin, lipitor, which accounted for $7.7 billion in sales.21 these extraordinarily high returns indicate that the pharmaceutical companies clearly have a vested interest in ensuring that their blockbuster drugs remain on the market. 22 there is a downside to keeping a problematic blockbuster drug on the market. keeping such a drug on the market may cost the pharmaceutical com­ pany millions, even billions, of dollars in lawsuits, negative public perception, for the largest sales volumes in the industry. jd 15 see merrill matthews, jr., drug company profits aren't a problem-they're the solution, healmcarenews, july 1, 2001, http://www.heartland.org/article.cfin?artld=640. 16 goozner, supra note 12, at 229. 17 ogbru, supra note 14. for example, ''( s]tatins differ in several ways. the most obvi­ ous difference is in their ability to reduce cholesterol." jd. they also differ in terms of their mechanism of action and chemical structure. jd. a few of the statins "are completely synthetic and have chemical structures that differ greatly from the natural statins." jd. 18 walsh & ostrow, supra note 5. 19 catherine arnst et al., the waning of the blockbuster drug, bus. wk. online, oct. 18, 2004, http://www.businessweek.com/magazinelcontent/04 _ 42/b3904034 _ mzo ll.htm. 20 2004 year-end, supra note 8. 21 ld. 22 it should be noted that although a blockbuster drug accounts for sales in excess of one billion dollars, it is difficult to compare a blockbuster drug to a non-blockbuster drug because the latter's sales can vary due to a number of factors, such as with respect to its relative popular­ ity and associated disease-state. 2007] pulling a blockbuster drug off the market 121 and decreased investor confidence. more importantly, the pharmaceutical company's inaction may have a negative impact on the health of patients who use and rely on the drug in the first place. the cost of a failed blockbuster drug can be especially devastating for pharmaceutical companies that require successful blockbuster drugs in order to recoup the high cost of developing and manufacturing these drugs. in addition, although the pharmaceutical industry enjoyed a 5.4% increase in sales in 2005,23 this number is significantly lower than the 8.3% increase the industry enjoyed in 2004.24 although the current growth rate is still a strong number, the withdrawal of blockbuster drugs vioxx and bextra contributed to the de­ clining growth from previous years.25 therefore, both the pharmaceutical in­ dustry and its companies require a blockbuster drug to succeed commercially, specifically before the company loses its right to exclusive marketing of the drug26 or the drug's patent expiration27, in order for the pharmaceutical industry to enjoy a strong growth rate and for its companies to recoup their investment in development and manufacturing of these drugs. 3. the evolving and future role of the pharmaceutical industry furthermore, prescription drugs have played an increasingly important role over the years, especially as the united states' population ages. 28 accord­ ing to the administration on aging, the older-aged segment of the united states' population is growing substantially.29 in addition, many of those reach­ ing the age of retirement will live 18.2 years longer than their predecessors. 30 according to these statistics, medications produced by the pharmaceutical in­ dustry have helped to sustain the lives of the octogenarian demographic. there­ fore, as a significant portion of the population grows older, the pharmaceutical industry will be placed under greater scrutiny to ensure that the drugs that are 23 ims health reports 5.4 percent dollar growth in 2005 u.s. prescription sales, imsheal11i.com, feb. 22, 2006, http://www.imshealth.com/ims/portallfron11articlec/0,2777 ,6599 _3665 _77180090,00.html [hereinafter percent dollar growth]. 24 2004 year-end, supra note 8. 25 percent dollar growth, supra note 23. 26 see2l c.f.r. § 314.108 (2006). 27 generally, a drug's patent expires after twenty years, although this number can vary due to a host of other factors. see fda.gov, frequently asked questions on patents and exclu­ sivity, http://www.fda.gov/cder/ob/faqs.htm#howo/o20many%20years%20is%20a%20patent% 20granted%20for? (last visited feb. 15, 2007). 28 see generally admin. on aging, u.s. dep't of heal til & human servs., a profile of older americans: 2004 passim (2004), available at http://www.aoa.gov/prof/statistics/ profile/2004/2004profile. pdf. 29 /d. in 2003, over two million persons reached age sixty-five. id. that same year, 1.8 million persons of age sixty-five or older died, which resulted in an annual net increase in the senior population of over 317,000. /d. 3q /d. 122 indiana health law review [vol. 4:115 being produced are safe, as well as efficacious. thus, as the number of drug withdrawals increases, this demographic is affected more than any other. iii. fda drug approval process presently, there is mounting internal and external pressure placed on phar­ maceutical companies to produce blockbuster drugs. internally, management understands that profitable drugs are needed in order to finance other opera­ tions, as is the case in many businesses. on the other hand, externally, share­ holders want novel blockbuster drugs because that often corresponds to increased profitability and as a result a simultaneous increase in dividend pay­ ments. because the average blockbuster drug's return on investment is only five percent, the large pharmaceutical conglomerates would need to produce two or three blockbuster drugs per year in order to grow sales by ten percent. 31 although such a number may seem absurd, especially considering that it costs hundreds of millions of dollars to produce a blockbuster drug, the pharmaceuti­ cal industry has in fact sustained such a pace. the number ofblockbuster drugs on the market has increased from seventeen in 1995 to sixty-seven in 2003.32 just as the number of blockbuster drug brands have increased, so too has the number ofblockbuster drug withdrawals. as a result, the fda's drug approval process has come under scrutiny by many experts. 33 even the agency that dic­ tates whether a drug is fit for introduction into the open market is not immune from criticism, especially when its self-acclaimed stringent drug approval process fails to uncover the drug's safety problems. · the drug approval process within the fda is still a rigorous process that consists of several phases of testing. 34 regulation of a new drug is performed by the center for drug evaluation and research, a branch of the fda. 35 the process for approval begins by requiring the pharmaceutical company to take steps to perform pre-clinical screening of the drug in order to prove through their subsequent submission of data to the fda that the drug is reasonably safe.36 in order to ensure that the drug is safe, during preclinical drug develop31 beyond the blockbuster drug: strategies for nichebuster drugs, targeted therapies and personalized medicine, bus. insights, feb. 2005, available at http://www .researchandmarkets.com/reports/295612. 32 visiongain, blockbuster drugs expected to rise by 93%to $262 billion by 2009 pre­ dicts visiongain, pr9.net, nov. 15,2004, http://www.pr9.net/health/medicine/1322 novem­ ber.html. 33 christopher placitella & justin klein, the civil justice system bridges the great divide in consumer protection, 43 duq. l. rev. 219, 220 (2005). 34 fooo&drugadmin.,u.s.dep't.ofhealrn&humanservs.,centerfordrug evaluation and research handbook passim {1998), available at http://www.fda. gov/cder/handbook/. 35 jd. 36 i d. before the fda allows the pharmaceutical company to use a drug or compound, in further initial, small scale pre-clinical studies, the pharmaceutical coinpany must put forth 2007] pulling a blockbuster drug off the market 123 ment, the pharmaceutical company must evaluate the drug's toxic and pharma­ cologic effects by conducting shortand longterm testing on animals. only if the drug passes the requirements of pre-clinical screening, will it undergo a se­ ries of additional screening phases. 37 during the next three phases, the drug is tested vigorously in order to en­ sure its efficacy and safety. for instance, during the first phase, the drug is in­ troduced and administered to humans. 38 these studies are closely monitored and are usually conducted with healthy volunteer subjects. 39 the object of these studies is to determine the metabolic and pharmacologic action of the drug in humans, including any potential side effects associated with increasing doses (if available). 40 during the second phase, early controlled clinical studies help determine the common side effects and risks associated with the drug. 41 finally, during the third phase, the effectiveness of the drug and the overall benefit-risk relationship of the drug are evaluated. 42 although the fda's drug approval process is stringent, the pressure to produce more blockbuster drugs has caused pharmaceutical companies to sub­ mit an increasing number of applications for new drug approval to the fda.43 requiring a thorough evaluation of each drug has put a considerable strain on the fda due to its lack of resources and manpower.44 moreover, lobbying ef­ forts by the pharmaceutical industry have since convinced congress to amend earlier statutes that previously required nearly fifteen years of fda testing for approval of a new drug.45 for example, in response to serious epidemics such as aids, the fda reduced the amount of time for reviewing a new drug to be­ tween six and twelve months.46 congress officially reduced the review time in 1992, when the prescription drug user fee act was passed in order to expedite data that the drug-compound is reasonably safe. 37 /d. during these phases, the new drug is screened for efficacy and safety through a series of clinically monitored trials. /d. "a clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments." the open door clinic, definitions ofhiv glossary, www.opendoorclinic.org/hivglossary.htm (last visited feb. 16, 2007). in essence, "[c]linical trials (also called medical research andre­ search studies) are used to determine whether new drugs or treatments are both safe and effec­ tive. carefully conducted clinical trials are the fastest and safest way to find treatments that work in people." /d. 38 rickng, drugs: from discovery to approval 144 (2004); see also food& drug admin., supra note 34. 39 food & drug admin., supra note 34. 40 /d. 41 ng, supra note 38, at 145-46; see also food &drug admin., supra note 34. 42 ng, supra note 38, at 146; see also food & drug admin., supra note 34. 43 see deborah g. parver, note & comment, expediting the drug approval process: an analysis of the fda modernization act of 1997, 51 admin. l. rev. 1249, 1249-53 (1999). 44 see id. at 1255. 45 see id. at 1253, 1255. 46 ng,supranote 38, at 164(statingthatmerck'saidsdrug.crixivan, was approved in just forty-two days). 124 indiana health law review [vol. 4:115 the drug approval process.47 curiously, although the amount of time required to review a drug has decreased, the number of drug withdrawals has continued to rise. the remaining question is whether there is a direct correlation between the reduced amount of review time and the increased number of drug with­ drawals in recent years. according to the pharmaceutical research and manufacturers association ("phrma"), an organization comprised of representatives from a number of pharmaceutical companies, there are significant costs associated with producing a blockbuster drug and bringing it to market.48 generally, the industry responds to claims that the drug approval process is not stringent enough by pointing to the substantial amount of resources invested in producing a blockbuster drug.49 the industry claims that pharmaceutical companies have a considerable stake in producing a drug that is both safe and efficacious. for instance, a block­ buster drug costs a pharmaceutical company an average of over $800 million dollars to develop from its infancy as a molecule. 5° in addition, of the five to ten thousand chemically synthesized molecules examined by the fda, only one ever becomes an approved drug. 51 therefore, it could be argued that the phar­ maceutical industry is more than committed to producing safe drugs, which can be directly attributed to the great number of drugs that are discarded due to problems in the earlier stages of development. regardless of these statistics, however, the alarming rise in the number of blockbuster drug withdrawals has caused many critics to "point the finger'' at the fda's reduced review time. during the 2004 senate finance committee hearings concerning the drug vioxx, doctor david graham, the associate di­ rector for science and medicine in the fda's office of drug safety, called the fda incapable of protecting the american public from another blockbuster withdrawal such as vioxx.52 he claimed that fda officials pandered to the 47 /d.; see also ctr. for drug evaluation & research, u.s. food & drug admin., pdufa reautiiorjzation performance goals and procedures (2005), available at http://www.fda.gov/cder/news/pdufagoals.htm. the prescription drug fee act required phar­ maceutical companies to pay a fee to the fda before commencement of a review of the respec­ tive company's new drug application. this fee was used to hire more reviewers and scientists in an effort to streamline the process and resulted in a new timeline for review consisting of only seven years. /d. 48 pharmaceutical industry profile 2006, supra note ll. 49 /d.; but cf marcia angell, the truth about the drug companies, the n.y. rev. of bks., july 15, 2004, available at http://www .nybooks.comlarticles/17244 (claiming the cost to develop a blockbuster drug is not as great as is claimed by the pharmaceutical industry). 50 pharmaceutical industry profile 2006, supra note 11; contra angell, supra note 49. st j. michael hayes, the united states drug approval process, at 3, http://www. conti­ nuingeducation.comlpharmtechldrapproval/drapproval.pdf?x= 1141768340&t= (last visited feb. 16, 2007). all drugs are created from chemically synthesized molecules. /d. the mechanism of action of a molecule differs from one drug to another, even if they are from the same class of drugs. see id. 52 placitella & klein, supra note 33. 2007] pulling a blockbuster drug off the market 125 wishes ofbig pharmaceutical companies, even so far as allegedly attempting to pressure him into changing his scientific conclusions and recommendations regarding certain drugs.53 the journal of the american medical association ("jama'') agreed with doctor graham and claimed that the fda's post­ market-approval-surveillance system was underfunded and understaffed. this shortage of adequate finances and manpower has led to thousands of deaths each year by drugs that should have been withdrawn in the first place. 54 further proof can be found by examining the fda drug approval process, which would reveal that although the process is stringent, in the past it has failed to weed out those drugs that were unsafe to place on the market. in addi­ tion, the heavy price tag placed on the development of each molecule increases the incentive for the pharmaceutical company to push the drug to market, espe­ cially if the drug is in the third phase of testing. often times in the third phase, the drug is viewed as an eventual release to the market and is often portrayed as such by the company. in doing so, the company's stock price increases as the company is viewed as having a strong pipeline that may lead to a more finan­ cially prosperous future. conversely, loss of such a drug during the third phase can be devastating financially and publicly for the company and its shareholders. in recent years, several high profile drugs have been pulled off the market due to safety con­ cerns. a withdrawal of a blockbuster drug may not only affect the company fmancially and legally, but can also affect its public image. therefore, the withdrawal of a blockbuster drug from the market can have a direct effect on not only the respective pharmaceutical company and its con­ sumers, but also the fda and other agencies that failed to prevent the drug from being introduced on the open market. it seems apparent from recent drug withdrawals that as the number of blockbuster drugs pulled off the market in­ creases, the fda's drug approval process will come under continued scrutiny. this may ultimately lead to significant changes in the way the fda handles new drug applications. n. legal ramifications of pulling a drug off the market when a pharmaceutical company pulls a drug off the market as a result of an fda mandate, it is in many cases conceding that the drug was somehow flawed. usually the flaw or flaws in a prescription drug pulled off the market can be attributed to safety concerns. in recent years, several high profile block­ buster drugs, such as rezulin and baycol, have been pulled off the market for just this reason. 55 many of these recently withdrawn drugs were used to treat a 53 /d. at 220-21. 54 id. at 221. 55 parke-davis/warner-lambert inc. (currently owned by pfizer) voluntarily withdrew rezulin from the u.s. market in 2000. jim morris, diabetes drug rezulin taken off market: 126 indiana health law review (vol. 4:115 wide variety of disease-states. 56 in such cases, patients and health care profes­ sionals had to find alternatives to treat these life altering diseases. conversely, the pharmaceutical companies that manufactured drugs, such as rezulin and baycol, 57 were inundated by a number of lawsuits. both companies are cur­ rently fighting the majority of these lawsuits domestically and globally. the legal ramifications of pulling a blockbuster drug off the market may be significant for both the plaintiff and the defendant-pharmaceutical company. first, a verdict against a pharmaceutical company can lead to large jury awards, specifically punitive damages. a pattern of such losses and large awards can lead to more lawsuits, including class action lawsuits, which may financially burden the company for a long time. it may also lead to a global settlement in order to prevent the company from going bankrupt. 58 conversely, if the plain­ tiffloses, usually after filing several appeals, there is very little recourse to seek compensation for the sacrifice of time spent and expenses incuited as a result of attorney's fees and court costs. this is even more demoralizing to the individ­ ual plaintiff than to its pharmaceutical counterpart because the latter can dig into its deep pockets and come out of such litigation essentially unscathed, aside from its attorney's fees and court costs. second, there may be criminal penalties. if the plaintiff can prove that the pharmaceutical company knew of the drug's safety defects and continued to market and sell it, the company and its principals may face criminal prosecu­ tion. those within the company who knew of the drug's problems and failed to disclose such concerns may even face possible jail time. this may also result in class action lawsuits against the company and may lead to large fines from the fda. a. vioxx lawsuits: the case against merck in 2004, vioxx was pulled off the market for safety reasons; at the time, vioxx was the most profitable drug ever to be withdrawn from the market in united states history. 59 merck withdrew vioxx from the market after the datapill linked to 63 liver-poisoning deaths, cnn.com, mar. 23, 2000, http://archives.cnn.com /2000/heal th/03/22 /diabetes.drug.01/index.html. bayer voluntarily withdrew baycol from the market in 2001. david brown, baycol pulled from market as numerous deaths linked to it, wash. post, aug. 9, 2001, at aol. 56 some of the blockbuster drugs pulled off the market recently, such as rezulin, baycol, and vioxx, treated disease-states such as diabetes, heart disease, and osteo-arthritis respectively. 57 rezulin and baycol were manufactured by pfizer and bayer respectively. 58 an example of a pharmaceutical global settlement occurred in november, 200 i, when tap pharmaceuticals inc. "agreed to pay a total of$875 million to resolve alleged violations of the prescription drug marketing act (pdma) and criminal and civil allegations of :fraudulent drug pricing and marketing conduct." judith a. waltz, multimillion dollar settlement signals government's increased scrutiny of pharmaceutical industry, drug benefit trends, nov. 2001, at 15-16, available at http:llwww.medscape.com/viewarticle/41490 1. 59 vioxx withdrawn after study suggests it .may double the risk of heart attack, seniorjournal.com, sept 30, 2004, http://www.seniorjournal.com/news/health/4-092007] pulling a blockbuster drug off the market 127 safety-monitoring board, which oversaw a long-term study of the drug, recom­ mended that the study be halted.60 in essence, patients in the study had an in­ creased risk of developing serious cardiovascular events, such as heart attacks and strokes, because of their continued use of the vioxx fifty milligram tablet, as compared to those patients simply taking a placebo. 61 the fda responded to merck's stunning announcement by stating that "merck did the right thing by promptly reporting these findings to the fda and voluntarily withdrawing the product from the market:.62 the legal ramifica­ tions of such a withdrawal were unprecedented and over the next few weeks and months, injury lawyers across the country postured for position in an at­ tempt to sue merck and obtain a piece of the vioxx injury pie. the legal consequences of the vioxx withdrawal were immense. in the united states alone 4,300 lawsuits were filed against merck, citing vioxx as the cause of an injury. 63 there may be several reasons why such a large num­ ber oflawsuits were filed. first, plaintiffs' attorneys targeted large pharmaceu­ tical companies, and many of them used this opportunity to show prospective clients that trial lawyers can sue big conglomerates like merck and hold them accountable. 64 second, a significant number of the cases were to be tried in jurisdictions that fail to cap punitive damages. 65 as a result, plaintiffs' lawyers were hoping that the advent of big-ticket verdicts against the company would result in the filing of more lawsuits.66 similar to cases involving claims against asbestos and breast implants, plaintiffs' lawyers hoped that this marked the be­ ginning of a long road oflitigation.67 finally, a defeat in the courtroom might be the ultimate consequence of the withdrawal because it can lead to substantial jury awards and a considerable number of subsequent lawsuits. additionally, in 2005, three highly publicized vioxx trials set the tone for 30vioxx.htm. vioxx was a non-steroidal anti-inflammatory drug within the category of drugs known as cox-2 inhibitors. id. it was prescribed by both specialists and general practitioners for pain associated with osteoarthritis. /d. also, since vioxx was marketed for the treatment of pain, many physicians prescribed it to octogenarians. 60 /d. 6t id. 62 /d. acting fda commissioner dr. lester m. crawford also stated that"[ a]lthough the risk that an individual patient would have a heart attack or stroke related to vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo." !d. 63 anthony j. sebok, what'snextfor merckanditslawyers? vioxx verdict likely to be reduced but could impact other cases, cnn.com, aug. 23, 2005, http://www .cnn.com/2005/la w /08/23/sebok. vioxxlindex.html. 64 sebok, supra note 63; jerry avorn, powerful medicines: the benefits, risks, and costs of prescription drugs 371 (2004). 65 sebok, supra note 63. 66 id. 67 id. a drawn out litigation process means that the company will likely settle, even those cases it might win, in an attempt to avoid a string of defeats that would provide other po­ tential victims the incentive to sue. id. it also could lead to forum shopping, resulting in ad­ verse publicity for the company in multiple jurisdictions . .. 128 indiana health law review [vol. 4:115 future litigation that would be sure to follow. each of these trials presented a unique opportunity to examine the legal consequences of pulling a blockbuster drug off the market. so far there is no clear winner as the decisions sometimes favor merck and other times favor the plaintiff. the first trial occurred in the texas case, ernst v. merck,68 in which the widow of the decedent who used vioxx for several months, claiming that vi­ oxx contributed to the decedent's death, sued merck for negligence in the de­ sign of their blockbuster anti-arthritic drug. 69 the jury awarded a verdict in favor of the plaintiff for $253 million, including $229 million in punitive dam­ ages. 70 the jury determined that merck acted with malice, which was defined as "an extreme degree of risk and conscious indifference to the rights, safety or welfare of others."71 this large award has several implications. first, as the largest award against a pharmaceutical company in u.s. history, it attracted hundreds of new lawsuits against merck filed by plaintiffs' attorneys who wanted a piece of the pie. second, the award sent a clear message to the pharmaceutical industry that pulling a blockbuster drug off the market could lead to crippling damage awards. third, merck was dealt a serious blow since this was only the first of thousands oflawsuits that it would face, and such a verdict and award set a very negative precedent. finally, such a verdict not only encouraged plaintiffs to file more lawsuits, it also discouraged plaintiffs from settling their cases, hoping for a similar outcome by taking their cases to trial. the second trial occurred in the new jersey case, humeston v. merck/2 and resulted in the pendulum swinging back in merck's favor. this case proved that winning a lawsuit against a pharmaceutical company that has vol­ untarily withdrawn a blockbuster drug because of safety concerns is an unlikely proposition and is a great risk for the plaintiff. in this case, even though the jury verdict was not permitted to address whether vioxx caused a heart attack, the jurors had determined that other risk factors and job stress were contributing factors. 73 the jury determined that merck provided adequate warning to prescribing physicians.74 this verdict was a giant setback for many plaintiffs because it occurred in new jersey, the loca68 texas jury awards $250 million in jm vioxx trial, mealey's prod. liab. & risk, sept. 5, 2005, at 23, 23 [hereinafter texas jury awards $250 million in im vioxx trial]. 69 texas jury awards $250 million in jm vioxx trial, supra note 68. 70 aaron smith, jury: merck negligent: merck blamed for death in vioxx suit; jury awards $253 million in damages. drug giant to appeal., cnnmoney.com, aug. 19, 2005, http://money.cnn.com/2005/08/191news/fortune500/vioxx. 71 texas jury awards $250 million in 181 vioxx trial, supra note 68. 72 new jersey jury finds vioxx warnings were adequate, mealey's prod. liab. & risk, dec. 2, 2005, at 29, 29 [hereinafter new jersey jury finds vioxx warnings were ade­ quate]. 73 new jersey jury finds vioxx warnings were adequate, supra note 72. 74 id. 2007] pulling a blockbuster drug off the market 129 tion of merck's corporate headquarters and the location of more than 2,700 other filed lawsuits. 7s nevertheless, this victory proved that in any lawsuit against a major pharmaceutical company (with deep pockets and even deeper resources), wins and losses during the course of the litigation process depend on the facts as presented in individual cases. 76 the third vioxx trial and first federal trial, plunkett v. merck, took place in houston, texas, and resulted in a mistrial. 77 in plunkett, the trial ended in a mistrial after the jury could not reach a conclusive verdict after nearly two and a half days of deliberation. 78 the judge stated that "the jury was split and unable to agree on a verdict."79 once again, the outcome of the trial rested on facts that ultimately left the jurors deadlocked. the three vioxx trials proved that pulling a blockbuster drug off the mar­ ket can have significant and unpredictable legal consequences for both the plaintiff and the defendant. these trials also proved that extraneous factors can dictate the outcome of the trial. for instance, in all three trials, the facts played a critical role in swaying or deadlocking the respective juries.80 in both the sec­ ond and third trials, the individual facts of each case dictated the outcome in merck's favor. in product liability cases, often the specific facts, such as the patient's administration of the pill or the patient's understanding of the pre­ scribing information, can play a pivotal role in swaying the jury one way or an­ other.81 another critical factor in determining the outcome was the jurisdictional location of the lawsuit. for instance, the large award in the first trial was not unusual for texas. moreover, the second trial was held in new jersey where merck was incorporated; therefore, finding an unbiased jury may have proven difficult for the plaintiff. finally, all three trials proved that a blockbuster drug being pulled off the market delineates the beginning of a long road oflitigation for both parties. thus, much like a boxing match, a resounding win in any one round can be easily reversed in subsequent rounds. these three cases are only a small sample of the cases that merck will face 75 ld. 76 /d. at the time of the verdict in merck's favor, there were 6,400 other lawsuits that had been filed against merck. merck acquitted in second vioxx suit, injury help line, nov. 10,2005, http://www.injuryhe1pline.com/index.rwl?category=news&section=phannaceutical& article=merck+acquitted+in+second+vioxx+suit&id= 1901. 77 jill federal vioxx trail ends in mzstrial; jury split, mealey's prod. liab. & risk. dec. 16, 2005, at 24, 24 [hereinafter jill federal vioxx trail ends in mzstrial; jury split]. 78 ld. 79 jd. 80 texas jury awards $250 million in jill vioxx trial, supra note 68; new jersey jury finds vioxx warnings were adequate, supra note 72; jill federal vioxx trail ends in mistrial; jury split, supra note 77. 81 it should be noted that this is not true in every case but seemed to matter in these early vioxx cases. 130 indiana heal til law review [vol. 4:115 in the next ten years. 82 these cases prove that the determining factors will be the merits of the respective case, the jurisdiction in which the case is tried, and the trial strategies employed by the parties. a resounding victory in one part of the country may be inconsequential to potential plaintiffs in other parts of the country. nevertheless, the legal consequences can greatly affect all pharmaceu­ tical companies and plaintiffs who use blockbuster drugs in the foreseeable fu­ ture. b. criminal indictments and substantial financial penalties a pharmaceutical company that pulls a blockbuster drug off the market ei­ ther voluntarily or involuntarily is likely to receive major media attention. most drugs are pulled off the market because there is indisputable evidence that the drug has caused health problems in those who used the drug. as a result, the next logical step is to question those involved in the development and manufac­ turing of the drug and to determine if such information could have been re­ vealed earlier. accordingly, if personnel within the pharmaceutical company had the information and failed to reveal its contents to the fda or to decision makers within the company, not only is the company subject to civil lawsuits, but those who failed to disclose the information may be criminally prosecuted and the company may be penalized through large fines. in such a case, criminal indictments will probably be filed because of the potential severity of such a situation. it is inexcusable for a company to withhold information proving that a drug could be potentially harmful to those patients whom it is intended to benefit. a little over a month after pulling vioxx off the market, merck revealed that it had been subpoenaed by the justice department concerning an investiga­ tion into the methods merck had used to market and sell vioxx. 83 in subse­ quent cases against merck, plaintiffs' attorneys are likely to point to internal merck memoranda that had at least three programs to train sales representatives "to misstate and misrepresent the truly dangerous nature ofvioxx to prescrib­ ing physicians," including a company document that alerted sales reps to dodge tough questions from physicians.84 in addition, plaintiffs' attorneys will also use internal merck e-mails and marketing materials as well as interviews with outside scientists to show that the company fought hard to keep safety concerns 82 there have been several cases following the initial three publicized cases. see brooks v. merck & co. inc., 443 f. supp. 2d 994 (s.d.lll. 2006); see also melton v. merck & co. inc, 2006 u.s. dist. lexis 37376 (b.d. ky. june l, 2006); see also salinas v. merck & co. inc., 2006 u.s. dist. lexis 12196 (s.d. tex. mar. 7, 2006). 83 amy barrett, merck: how much misery after vioxx? bankruptcy seems unlikely, but lawsuits could be a drain for years, bus. wk. onune, nov. 22, 2004, http://www.businessweek.com/magazine/content/04_ 47/b3909051_mz011.htm?chan=search. 84 cindi solomon & sandy summers, vioxx: birth and death of a super aspirin, 1-6 mealey's lmg. rep. a:r1hritis drugs 15 (2004). 2007] pulling a blockbuster drug off the market 131 from destroying the drug's profit.8s furthermore, in 2005, the new england journal of medicine claimed that the authors of vigor, a landmark vioxx clinical outcomes trial, erased data suggesting that three patients who took vi­ oxx in the trial suffered heart attacks. 86 although there is mounting evidence that merck employees knew about vioxx's safety problems, the justice de­ partment has yet to file any criminal indictments against merck. in the past, a company's voluntary withdrawal of a blockbuster drug did not result in criminal indictments against decision makers within the company because in doing so the company conceded the drug's lack of safety and as a result attempted to rectify such a problem. 87 as more pharmaceutical compa­ nies require successful blockbuster drugs in order to offset the ever increasing research, development, and litigation costs, executives are faced with increasing pressure to circumvent any problems with potential blockbuster drugs that may arise. in doing so, it is likely that these executives might face criminal prosecu­ tion for attempting to hide concerns that might jeopardize the drug's commer­ cial future. another consequence of concealing information that may reveal a block­ buster drug's safety problems is the imposition of substantial financial penalties on the pharmaceutical company that owns the drug. for instance, in 1996, warner-lambert pharmaceuticals, before being acquired by pfizer, submitted rezulin, a drug aimed at treating patients with diabetes, to the fda. 88 during the drug approval process, warner-lambert pressured the fda into approving rezulin, a drug with known side-effects, which were fatal in some cases. 89 this decision to approve the drug was ill-fated as the drug was allegedly related to the deaths of 391 people by the time it was pulled from the market. 90 prior to its submission ofrezulin to the fda, warner-lambert was al­ ready being investigated by the fda and the justice department for its con­ cealment of key information and actions during the drug approval process. 91 eventually, warner-lambert pled guilty in 1995 for "concealing quality-control problems in its drug manufacturing" processes and received a ten million dollar 85 alex berenson, in training video, merck said vioxx did not increase risk of heart attack, n.y. times, july 21, 2005, at c4, available at http://www.vioxx-recall-lawsuit.com /news/video.pdf. 86 chris rangel, unprecedented! the new england journal accuses vioxx study au­ thors of cover-up!, ranoelmd.com, dec. 9, 2005, http://www.rangelmd.com/2005112/new­ england-journal-fingers-vioxx.h1ml. 87 a company can rectify such a problem by further testing the drug or settling lawsuits with any adverse party. 88 melissa marie bean, fatal flaws in the food and drug administration's drug­ approval formula, 2003 utahl. rev. 881,904,908 (2003). rezulin was approved to lower blood sugar, which is critically important to diabetic patients because it helps the body process insulin. /d. at 903. 89 /d. at 904-05. 90 /d. at 903. 91 !d. at 904. 132 indiana h:ealtii law review [vol. 4:115 fine; at the time, this was one of the largest fines ever imposed on a drug manu­ facturer. 92 although that number may not seem significant for a large pharma­ ceutical conglomerate with deep pockets, the fine represented the determination by governmental agencies that the pharmaceutical company erred in its manu­ facturing of the drug. in tum, such a finding could be used by plaintiffs' attor­ neys in subsequent civil lawsuits. v. business ramifications of pulling a drug off the market in addition to legal consequences, such as civil lawsuits and criminal in­ dictments, a pharmaceutical company can also face business consequences as a result of a blockbuster drug withdrawal from the market. one of these conse­ quences is the loss of an asset that produces a significant amount of revenue for the company. another is the myriad of lawsuits and the significant amount of capital required for their defense. also, the company can face a decrease in the market's valuation of the company, specifically in its stock price, which can affect perception and investor confidence in the company's ability to bounce back from such a setback. nevertheless, regardless of the reason, the loss in . profit and future revenues can be devastating for any company, especially ifthe drug is a significant asset within its product line. bayer pharmaceuticals faced the business ramifications of pulling a block­ buster drug off the market when, in 2001, it pulled baycol,93 one of its most profitable pharmaceutical drugs used to treat high cholesterol, off the market. as a result, bayer had to prepare itself for the long road of litigation by stock­ piling a significant amount of capital to fight lawsuits.94 unlike its statin coun­ terparts, zocor, lipitor and pravacol, bayer's baycol was related to the deaths of nearly one hundred people and was associated with causing painful side ef­ fects, such as rhabdomyolosis, which causes weakening of the muscles.95 since its withdrawal, many plaintiffs' attorneys had been critical of bayer's handling of the drug, even claiming that bayer's litigation costs (due to the withdrawal of baycol) would ultimately cost fifty billion dollars in settlements and judgments before it was over.% as a result of the negative press it received and the numerous lawsuits that were filed against it, bayer faced a significant financial setback due to baycol' s withdrawal. at first, bayer settled 2,312 cases for $872 million, including sev­ eral settlements of one million dollars for the roughly 100 death cases.97 in or92 /d. 93 baycol was a cholesterol lowering drug within the category of drugs known as statins. 94 monica langley, bayer, pressed to settle a flood of suits over drug, fights back, wall st. j., may 4, 2004, at al, availableatbttp://webreprints.djreprints.com/1220931162452 .httnl. 9s id. 96 id. 97 !d. 2007] puujng a blockbuster drug off the market 133 der to cover the legal costs associated with the nearly 9,278 lawsuits pending since baycol was pulled :from the market, bayer set aside nearly $1.2 billion, mostly provided by insurers. 98 furthermore, bayer had to plan for any possible losses in such cases or in settlement of some of the lawsuits. from its initial withdrawal ofbaycol until2004, bayer had settled 2,312 lawsuits and as are­ sult paid nearly $872 million. 99 there were over 9,000 lawsuits pending, which plaintiffs' attorneys, such as mikal watts, believe will end up costing the com­ pany in excess of fifty billion dollars.100 therefore, not only did bayer lose one of its most profitable products, but it was faced with the prospect of using capi­ tal that it had reserved for research and development of other compounds to fend off plaintiffs' attorneys who wanted a piece of the ever-increasing lawsuit pie. another possible fmancial consequence of pulling a drug off the market is the stock market's downward valuation of the company in terms of its stock price. in bayer's case, as a result of the thousands of lawsuits that had been filed against the company and the long road oflitigation ahead which the com­ pany would inevitably have to face over the next decade, the company saw a significant setback in its stock price.101 the lack of market confidence in bayer remained even though bayer produced several high profile blockbuster drugs after baycol's withdrawal, including levitra, a drug used to treat erectile dys­ function. another example of a company's stock devaluation due to a drug with­ drawal occurred when merck voluntarily withdrew vioxx from the market. arguably, no pharmaceutical company has faced wall street's wrath quite like merck, which faced a significant decrease in stock price after pulling vioxx off the market because of impending litigation.102 it is easy to see how investor faith in the pharmaceutical industry has begun to wane as a result of continual litigation103 and the fact that vioxx was the ninth prescription drug to be invol­ untarily withdrawn from the market due to death or injury in the last seven years. 104 also, vioxx was a different type of blockbuster drug: vioxx was a 98 /d. 99 /d. 100 /d .. 101 yahoo! finance, bayer historical prices, date range: nov. 18, 2000 to jan. 4, 2003, http://finance.yahoo.com/qlhp?s=bay&a=lo&b=18&c=2000&d=oo&e=4&f=2003&g=m (last visited feb. 20, 2007). from 2001 to 2003, bayer's stock price decreased by approximately eighteen dollars, in large part due to the damage caused by the withdrawal ofbaycol from the market and a lack of confidence from investors that the company would bounce back in the wake of impending litigation. 102 yahoo! finance, merck historical prices, date range: aug. 2, 2004 to nov. 4, 2004, http://finance.yahoo.com/qlhp?s=mrk&a=07&b=2&c=2004&d=10&e=4&f=2004&g=d (last visited feb. 20, 2007). in a span of three months, from august 2004 to october 2004, merck's stock price dropped by approximately sixteen dollars due to the voluntary withdrawal ofvioxx. 103 /d. 104 placitella & klein, supra note 33, at 222. 134 indiana health law review [vol. 4:115 veritable super blockbuster drug, if such a term exists. it had entered the mar­ ket to much hype in 1999 and became an instant success, grossing over one hundred million prescriptions, including twenty million users, and about $2.5 billion in annual sales. 105 the fact that vioxx was such a highly advertised drug led to a firestorm of publicity and made it all the more vulnerable to indi­ vidual plaintiff and class action lawsuits, such as personal injury tort actions, derivative lawsuits, congressional investigations, and securities and exchange commission inquiries.106 subsequently, on the day vioxx's withdrawal was announced, merck shares lost more than twelve dollars per share, dropping from forty-five to thirty-three dollars per share, later stabilizing to around thirty dollars per share.107 the withdrawal ofvioxx also caused merck, the nation's third largest pharmaceutical company, to be thought of as a potential merger target.108 in fact, in the months to follow, merck's board of directors offered special bo­ nuses to 230 of its most senior managers, which would be triggered if either the company was taken over by another firm or if some other firm acquired twenty percent of its outstanding shares. ul9 the vioxx episode proved that not only is the pharmaceutical company susceptible to a drop in stock price, but as a result, the company may also face a hostile takeover by another company, greatly affecting investor confidence in the company. nevertheless, any company that wished to take over merck would also have to take on the thousands oflawsuits that merck faced as are­ sult ofvioxx's withdrawal. furthermore, vioxx' s withdrawal cost many merck employees their jobs. since the withdrawal, merck has planned to layoff nearly 7,000 employees, most of whom held production plantjobs.110 in addition, top executives are not often spared after a major drug withdrawal. for instance, merck's chairman and chief executive officer, raymond gilmartin, abruptly resigned shortly after vioxx was withdrawn from the u.s. market.m therefore, the business 105 richard a. epstein, regulatory paternalism in the market for drugs: lessons from vioxx and celebrex, 5 yalej. heal1hpol'yl. &e1hlcs 741,741 (2005). 106 id. at 742; see also congressional hearing focuses on merck's marketing/or cox-2 drug vioxx, the kaiser family found. daily reports, may 6, 2005, http://www. kaisemetwork.orgldaily _reports/rep_ index.cfin?hint=3&dr_ id=29882. 107 epstein, supra note i 05, at 743; see also aaron smith, canadian vioxx study chal­ lenges merck: vioxx increases heart attack risk in first few weeks ofuse, study says; merck dismisses findings., cnnmoney.com, may 3, 2006, http:/lm.oney.cnn.com/2006/05/03/news /companieslvioxx/index.htm. 108 epstein, supra note 105, at 743. 109 id. 110 joseph kay, merck announces 7,000 layoffscontinued attack on jobs and wages in us, world socialist web site, dec. 2, 2005, http://www.wsws.orglarticles/2005/ dec2005/jobs-d02.shtml. 111 'phil taylor, manufacturing head takes merck top spot as gilmartin quits, drugresearcher.com, sept. 5, 2005, ht1p://www.drugresearcher.com/news/ng .asp?n=598442007] pulling a blockbuster drug off the market 135 ramifications of pulling a drug from the market can affect all of a company's divisions, from the boardroom to the factory floor. finally, it should be noted that once the patent on a blockbuster drug ex­ pires, other companies can use the same drug's formula to create generic drugs. the proliferation of generic drugs often cannibalizes the market for the original blockbuster drug. therefore, for pharmaceutical companies that possess multi­ ple blockbuster drugs, one of the drugs whose patent may be close to its expira­ tion, a drug withdrawal of the other drug or drugs may be financially crippling. as a result, this may lead to increasing motivation on the part of the respective pharmaceutical company to produce more blockbuster drugs in order to make up for the loss of these profitable assets.112 vi. ethical considerations of pulling a drug off the market the decision to withdraw a blockbuster drug from the market can present ethical dilemmas to the following parties: the pharmaceutical company, the regulatory agencies, such as the fda, and the pharmaceutical industry as a whole. for instance, before pursuing a withdrawal, the pharmaceutical com­ pany must take into account that there are patients who may be dependent on these arguably life altering drugs, such as vioxx and lipitor.113 in addition, the pharmaceutical industry is forced to consider that many patients are "counting on industry research to produce new treatments for diseases like rheumatoid arthritis and diabetes."114 finally, regulatory agencies such as the fda have begun to carefully scrutinize ethical considerations because "nobody wants to be on 60 minutes being asked why a dangero\!-s drug· was approved" and whether the fda took into account that countless americans that would be negatively affected due to side effects and many more would be left without a viable alternative once that drug was withdrawn from the market.115 subsequently, all of the players in this drama have begun to take into con­ sidemtiem how a drug withdrawal may affect not just their respective entities, but also the lives of many patients. the most prominent player in this drama, however, is the pharmaceutical company, and although the fda and the phar­ maceutical industry also face certain ethical issues, most of these issues are a by-product of those faced by the pharmaceutical company. as a result, for the purposes of this note, the pharmaceutical company's ethical considerations or lack thereof will be examined and scrutinized. manufacturing-head-takes. 112 greg radinsky, the spotlight on pbms: federal enforcement of the anti-kickback statute on the pharmaceutical benefit management industry, 2 j. healml. 213 (2003). 113 alex berenson, big drug malrers see sales erode with their image, n.y. t1mes, nov. 14,2005, atal. 114 ld lis /d. 136 indiana ileal til law review [vol. 4:115 a. ethical considerations faced by the pharmaceutical company before and after drug withdrawal although a withdrawal might be in the best interests of the pharmaceutical company, it is often not in the best interests of the patients who use the drug and are dependent on it for their daily activities. therefore, this section of the note will examine the ethical considerations that a pharmaceutical company must undertake before and after a drug withdrawal. 116 obviously from the perspective of a pharmaceutical company, a. drug withdrawal is not an ideal solution because it leads to negative public percep­ tion, strained investor relations, and loss of a valuable asset. 117 in short, there are rarely any positive aspects to a drug withdrawal. before a drug withdrawal has transpired, however, it is important for a pharmaceutical company to note that it can minimize the negative aspects of a drug withdrawal with a proper handling of the situation. therefore, a pharmaceutical company's evaluation of the ethical considerations before a drug withdrawal may mitigate the negative public perception and strained investor relationship it is sure to face. the stakes for all involved in a drug withdrawal, whether voluntary or in­ voluntary, are enormous. as a result, before a decision is made as to whether a blockbuster drug will be withdrawn from the market, the respective pharmaceu­ tical company must evaluate how such an announcement will affect the count­ less number of patients who are counting on the drug to treat a life-altering ailment. in addition, such an announcement also forces health care profession­ als to face the prospect of finding alternative forms of relief for patients who can no longer use the withdrawn blockbuster drug. in the case of voluntary withdrawal, the pharmaceutical company can balance such ethical considera­ tions with the fact that they must ensure the safety of the general public. also, the company can fall back on the fact that it took all the necessary precautions, such as adding warning labels as required by the fda, but in such a case, the risk outweighed any potential benefit that the blockbuster drug provided.118 conversely, the pharmaceutical company is faced with the prospect of continuing to market and manufacture a defective product, particularly, one that posed a danger to those patients who used it. in addition, the pharmaceutical company also must consider the ethics of continuing to market a product whose· failures are delineated in clinical outcomes studies. as a result, the pharmaceu­ tical company's failure to act may have led to countless more deaths that may have been avoided through both the drug's withdrawal from the market and timely notice of the drug's withdrawal to physicians and patients.119 therefore, 116 epstein, supra note 105, at 745. 117 aaron smith, drug company could use a face lift, cnnmoney.com, aug. 19, 2005, http://money.cnn.com/2005/08/16/newslfortune500/drugindustryfmdex.htm?section= money _latest. lis jd. 119 see bean, supra note 88. 2007] pulling a blockbuster drug off the market 137 a failure to take into account these important ethical considerations can lead to devastating consequences including a fda mandated withdrawal, negative public perception, and strained investor relationships. every pharmaceutical company must balance the benefits of producing a blockbuster drug with the risk of loss of life or serious injury that may result due to an adverse event or other usage problem. in addition, every pharmaceu­ tical company, through their membership in phrma, understands that they have an important duty to treat patients on their road to recovery. 120 neverthe­ less, given the ethical duties voluntarily undertaken by the pharmaceutical in­ dustry and its companies, pharmaceutical companies are continually faced with accusations from the public, government officials, and regulatory officials that they failed to take into account the ethical consideration of continuing to manu­ facture a drug whose safety problems were readily ascertained from ongoing clinical-outcomes studies. 121 in addition, although in recent years, pharmaceutical companies have been forced to withdraw an increasing number of blockbuster drugs, many of these drugs have been withdrawn after a significant number of patient deaths. for instance, from 1997 until200 1, thirteen drugs were pulled off the market, hav­ ing been linked to consumer deaths and severe side effects. 122 several of these thirteen drugs were on the market for many years before they were withdrawn, begging the question whether the respective pharmaceutical company should have been allowed to wait for evidence of the drugs' safety problems to accu­ mulate before finally being forced to withdraw the drug, especially in light of their ethical obligation to improve patients' well-being. 123 a more recent example of a pharmaceutical company's alleged failure to withdraw a drug from the market despite the proof of its safety problems was the vioxx drug withdrawal. several notable medical journals, including the 120 pharmaceutical research & manufacturers of am., about phrma, http://www.phnna.org/about_phnna/ (last visited feb. 20, 2007). phrma is an association of pharmaceutical companies that helps regulate the pharmaceutical industry. i d. "phrma' s mis­ sion is winning advocacy for public policies that encourage the discovery oflife-saving and life enhancing new medicines for patients by pharmaceutical/biotechnology research companies." pharmaceutical research & manufacturers of am., mission statement, http:/ /www.phrma.org/mission _statement!. 121 the baycol/lipobayscandal: first trial set to start for bayer's baycol, drratif­ foundation.org, feb. 18,2003, http://www4.dr-rath-foundation.org/pharmaceutical_ business/ baycol!baycol08.htm. the dr. rath health foundation is a leading website providing information on natural health. i d. during a trial against bayer, the plaintiff attempted to show that "bayer withheld from the fda negative results ofbaycol 's clinical trials." i d. 122 safety-based drog withdrawals (1997-2001), fda consumer mag., jan.-feb. 2002, available at http://www.fda.gov/fdac/features/2002/chrtwithdrawals.html. the thirteen with­ drawn drugs include baycol, raplon, lotronex. propulsid, phenylprpanolamine, rezulin, his­ mana!, raxar, posicor, duract, seldane and seldane-d, pondimin, and redux. id. 123 id. 138 indiana heal1h law review [vol. 4:115 lancet, 124 criticized merck's handling of the vioxx situation, specifically, its failure to withdraw the drug when the existence of safety issues became obvi­ ous. 125 during the vioxx senate hearings months after the withdrawal, asso­ ciate director for science and medicine in the fda's office of drug safety, doctor david graham, "explained that vioxx is a prime example of the na­ tional tragedy that occurs when the fda and the manufacturer'' do not take into consideration the effect a failure to withdraw the drug might have on prospec­ tive and current patients. 126 he stated that, "vioxx •may be the single greatest drug safety catastrophe in the history of this country' that •largely could have been avoided but wasn't."'127 furthermore, "doctor graham estimated that 88,000 to 139,000 americans were injured by vioxx" and that thirty to forty percent of them probably died, analogizing the magnitude of the harm to "the rough equivalent of 500 to 900 aircraft [sic] dropping from the sky." 128 many prominent members of the medical community agreed with doctor graham that countless deaths and much suffering could have been avoided had vioxx been recalled four years earlier. this opinion was supported by an editorial appear­ ing in the the lancet.129 in the article, the author commented that both "merck and the fda acted out of ruthless, short-sighted, and irresponsible self­ interest."130 merck was not the only pharmaceutical company in recent years that failed to take into account the ethical ramifications of pulling a drug off the 124 the lancet is a medical journal originally foooded in 1823. thelancet.com, about the lancet, http://www.thelancet.com/about (last visited feb. 20, 2007). it publishes clinical trials and opinions of notable health care professionals. id. it claims not to be affiliated with any medical organization. ld 125 tom armitage, merck should have pulled vioxx in 2000study, reuters, nov. 4, 2004, available at http://www.lexisnexis.com (click on news and business, click on individual publications, click on r, click on reuters news) (arguing that merck executives should have withdrawn vioxx from the market in 2000 while citing a report in the british medical journal, "the lancet". in that report, ''researchers at the university of berne said there was substantial evidence of the dangerous side effects of the drug by the end of2000, but the moooting data was not analyzed properly"); see also richard horton, vioxx, the implosion of merck, and after­ shocks at the fda, 364 the lancer 1995, 1995-1996(2004)(citingacumulativemeta-analysis showing the cardiovascular risks ofvioxx as early as 2000); contra peters. kim & alise s. reicin, discontinuation ofvioxx, 365 the lancet 23,23 (2004) (arguing analyses by juni and horton of past vioxx meta-analyses reached flawed conclusions). 126 placitella & klein, supra note 33, at 221; see also testimony of david j. graham, md, mph: november 18, 2004, available at http://www.mercola.com/2005/mar/2 /david_graham_testimonial.htm, cited in joseph mercola, vioxx reapproved by fda panel members with ties to drug companies, eiieai.rnv news you can use, mar. 2, 2005, http://www.mercola.com/2005/mar/2/vioxx _ fda.htm. 127 placitella & klein, supra note 33, at 221. 12s id. 129 mike adams, reputation of the fda in shambles after vioxx scandal; calls for wholesale fda reform gain momentum, newstarget.com. nov. 6, 2004, http://www. newstarget.com/002157 .html. 130 id. 2007] pulling a blockbuster drug off the market 139 market. in 2001, baycol was withdrawn from the market, but only after it had been linked to thirty-one deaths. 131 bayer claimed that the drug was safe, but "[t]he industry's focus on producing drugs for chronic conditions like depres­ sion and diabetes has vastly increased the pool of potential plaintiffs, because medicines for those diseases are taken by millions of people."132 moreover, "because clinical trials for new drugs are conducted on only a few thousand subjects, the tests do not always discover ... dangerous side effects."133 bayer's argument can be criticized for several reasons. first, more testing should have been performed, especially when the drug is being mass produced and marketed to a wide number of patients and physicians. 134 second, the drug was withdrawn after thirty people died during post-marketing surveillance, a number that seems much too high given the fact that this drug was used to pre­ vent heart attacks and strokes. 135 in sum, more consideration should have been given to the fact that the drug was not properly tested and could negatively af­ fect many of the patients for whom it was prescribed. b. a blockbuster drug's withdrawal may affect those patients who have not reacted negatively to the drug another ethical consideration that a pharmaceutical company must con­ sider when deciding whether to withdraw a blockbuster drug from the market is how such a withdrawal will affect current patients.136 many patients depend on drugs such as vioxx and bextra, not only for their pain relief properties, but also because these drugs give patients the ability to perform activities that oth­ erwise would not be possible without pain. 137 as a result, due to the with­ drawal, these patients are not afforded the chance to determine whether continued use of the withdrawn drug and any possible associated health risks 131 posting of louise mckichan, baycol killed 140 people taking its statin, to http://www.rxlist.com/rxboard/pravachol.pl?read=143 (feb. 26, 2005, 15:28 est). 132 alex berenson, trial lawyers now take aim at drug makers, n.y. times, may 18, 2003, ata6. 133 id. 134 see ben harder, dangerous practices: critics see flaws in drug-safety monitoring, sci. news onune, feb. 5, 2005, http://www.sciencenews.org/articles/20050205/boblo.asp. critics of bayer claim that the company had become aware of the hazards even as it continued to sell baycol and that it imperiled its customers by choosing not to disclose those risks fully. several thousand lawsuits have been brought against the company. four researchers who were paid by prosecutors to testify as expert witnesses studied the medical literature and internal company documents that were made public during the legal proceedings. reporting in the same issue of jama in which graham's report appears, they conclude that the data bayer released while marketing baycol did not tell the whole truth about the drug. /d. 135 /d. 136 see julie appleby & anita manning, for those in pain, relief trumps risks of banned painkillers, usa today, jan. 4, 2005, at la, available at http://www.usatoday.com/newsl health/2005-0 1-04-painkillers _ x.htm. 137 see id. 140 indiana health law review [vol. 4:115 may be worth the risk, given the very real possibility that without these drugs, their quality of life would be substantially diminished. 138 subsequently, without these drugs many patients are forced to use substi­ tute drugs that are often not as efficacious or potent. 139 in some cases, the sub­ stitute drugs can also cause distress and side effects.140 for instance, with the withdrawal of vioxx and bextra, many patients were forced to use over-the­ counter drugs such as advil and aleve, both of which can also cause cardio­ vascular problems and digestive distress, although at a much lower rate than the cox-2 inhibitors.141 furthermore, withdrawal ofmanyofthe blockbuster drugs does not affect all patients negatively, causing many patients to wonder why they have been deprived of effective treatment. in most drug withdrawal cases, the vast majority of patients are not at risk for any of the side effects listed.142 in fact, an fda advisory panel even concluded that vioxx was safe enough to be returned to the market as long as patients were better warned of the risks.143 furthermore, these patients might actually be more at risk from substitute drugs than from the withdrawn drugs. therefore, many patients are left to wonder 138 see id.; see also life without vioxx: what's a patient to do?, consumeraffairs. com, oct. 1, 2004, http://www.consumeraffairs.comfnews04/vioxx_alternatives.html. 139 see life without vioxx: what's a patient to do?, supra note 138. 140 mayo clinic staff, nsaids: how to avoid side effects, apr. 3, 2006 [hereinafter nsaids: how to avoid side effects] (on file with author). aspirin and advil are categorized as non-steroidal anti-inflammatory drugs ("nsaids"), which are known to cause stomach ulcers and other gastrointestinal side effects. see mayoclinic.com, anti-inflammatory drugs, nonsteroidal (systemic), http://www.mayoclinic.com/health/drug-information/dr202743 (last visited feb. 24, 2007). other classes ofnsaids can also cause cardiovascular problems. nsaids: how to avoid side effects, supra. 141 see life without vioxx: what's a patient to do?, supra note 138. 142 see painconcem.com, how safe are my pills?, mar. 3, 2005, http://www. painconcem.org.uk/pages/page62.php. in a recent study, the united states food and drug ad­ ministration ("fda") examined heart attack risk in patients who used vioxx. !d. the fda studied a total of 1.4 million californians who were using painkillers, including 1,000,000 pa­ tients who were using ibuprofen, 400,000 using naproxen, 40,000 using celecoxib, and 27,000 using vioxx. id additionally, among the 1.4 million patients, the total number with coronary heart disease was 8,1 00. /d. "[b]ut when the incidence of coronary heart disease was compared with individual drugs they found a 1.6x higher risk, i.e. 1% in patients using vioxx. so if you are a doctor in california and you have 1000 patients on painkillers other than vioxx, you might find that 6 of them have coronary heart disease. and if you have 1000 patients on vioxx you might find that 10 have heart disease. that's the problem. how do you decide if such a smau increase is chance or genuinely due to the drug?'' /d. 143 fda panel concludes vioxx safe enough to return to market, newstarget.com, feb. 28, 2005, http://www .newstarget.comf005033.html; vioxx could be sold again, mealey's lmo. rep. artiiritis drugs, feb. 1, 2005, at 8, 11 [hereinafter vioxx could be sold again]. with the approval of a closely divided joint advisory committee of the fda that also voted to keep competitors celebrex and bextra available, vioxx could re-enter the pharmaceutical mar­ ketplace. a joint committee of thirty-two expertsconvenedbythefda voted 17-15 onfeb.18, 2005, that vioxx should be permitted back on the market. the committee voted 31-1 in favor of ce1ebrex and 17-13 with two abstentions for bextra. vioxx could be sold again, supra. 2007] puli.jng a blockbuster drug off the market 141 whether the chances of being hanned by a side effect of a withdrawn drug out­ weigh the increased quality oflife associated with using the withdrawn block­ buster drug.144 c. balancing ethical considerations with the company's stated goal of profitability most phannaceutical companies must consider the ethics of putting profits before patient safety. in the 1950s, merck patriarch and president george merck remarked, "medicine is for the people. it is not for profits. "145 in recent months, his company has been criticized for hiding the problems associated with vioxx in order to increase profits.146 although such allegations have not been substantially proven, companies that fail to consider the plight of patients and their families are likely to suffer from negative public perception that may affect the company for years to follow. in addition, such companies would likely face endless litigation and claims of negligence, which could continue for a seemingly indefinite period of time. when making the decision to withdraw a drug from the market, a phanna­ ceutical company must first consider the patient. often, a company is forced to confront the families of the patients who died or were injured as a result of us­ ing the blockbuster drug in question. but the company must also consider the plight of those patients who have not experienced side effects in connection with use of the drug. such patients may be banned as a result of the drug being withdrawn from the market, particularly if there is a lack of efficacious substi­ tutes. therefore, the ethical ramifications of withdrawing a blockbuster drug from the market are numerous and affect all parties involved. vii. considerations of culpabll..l'iy in pulling a drug off the market the question of who is at fault when a drug is withdrawn from the market is not easily discernible, even though the parties who are responsible can be easily identified. most of the time, the party held responsible is the most visible party, usually the pharmaceutical company that developed and marketed the failed product. pharmaceutical companies, however, are large conglomerates with multi-tiered management cotntn\ttees and divisions. as a result, assigning the blame to a particular individual or division of the com144 see vioxx could be sold again, supra note 143. 145 raymond v. gilmartin, chairman. president, and chiefexecutive officer, merck & co. inc., remarks of raymond v. gilmartin, chairman, president, and chiefexecutive officer, merck & co., inc. at town hall los angeles, july 29, 2004, available at http://www.merck .com/newsroom/executive_ speeches/072904.html. 146 see medical journal revelation that study omitted 3 deaths prompts call for mzs­ trial, mealey's lmo. rep. arthritis drugs, dec. 1, 2005, at 5, 6. 142 thidmnah~thlawrevmw [vol. 4:115 pany can be almost impossible and requires proof that certain individuals had knowledge of the drug's safety failures and subsequently failed to report them. a. to what extent is the pharmaceutical company at fault? the proof required to hold a pharmaceutical company liable for marketing and distributing an unsafe product is difficult to produce. after a drug has been pulled off the market, both the fda and the respective pharmaceutical com­ pany incur significant expenses in order to investigate how such a safety failure transpired. such investigations can take years and may cost millions of dollars; nonetheless, they produce valuable evidence-based answers regarding the drug's failure. any information regarding management malfeasance and a fail­ ure to report important safety information is not easily discoverable. therefore, even though a pharmaceutical company may be held liable for continuing to mass market and produce an unsafe product, it may escape any punitive liability because the opposing party will likely be unable to produce sufficient proof that the pharmaceutical company's management knowingly and intentionally pro­ duced the harmful drug. moreover, pharmaceutical companies argue that it is difficult to predict how a patient will react to a drug after years of concomitant treatment with other drugs. for instance, most drugs are tested under rigid clinical conditions. when placed on the market, however, a patient may fail to read the prescnbing information circular147 carefully. often times, patients ingest a drug concur­ rently with other substances, such as food, drinks, or other drugs, which is strictly forbidden in the drug's prescribing information. in addition, most drugs have long half-lives.148 as a result, a drug can be present in a patient's body for many years. 149 because of this, it is difficult to assess the long-term effects of the drug because the drug usually is not tested for that length of time during 147 a prescribing information circular is a sheet of paper that is included when a drug is prescribed to a patient and is required to contain, among other requirements, "a summary of the essential scientific information" and comprehensive prescribing information. labeling re­ quirements for prescription drugs and/or insulin, 21 c.p.r. §§ 201.56 to 201.57 (2006). it also provides the patient with other information, such as concomitant use and the drug's mechanism of action. ld § 201.57. it is "also referred to as a package insert, product label, or product in­ formation." hepititisbhelp.com, glossary, http://www.hepatitisbhelp.com/hepatitis _b_glossary.html (last visited feb. 24, 2007). 148 answers. com, dictionary, half-life, http:/lwww.answers.com/topiclhalf-life (last vis­ ited feb. 24, 2007). the half-life of a substance subject to exponential decay is "[t]he time required for half of the quantity of a drug • • .to be metabolized or eliminated by normal biological processes." /d. 149 see, e.g., julienne k. kirk & john g. spangler, alendronate: a bisphosphonate for treatment of osteoporosis, am. family physician, nov. 1, 1996, available at http://www. findarticles.com/p/articles/mi _ m3225/is _ n6 _ v54/ai _18890140. for instance, the terminal half­ life offosamax, a drug that helps treat osteoporosis in men and women, is estimated to exceed ten years. /d. 2007] pulung a blockbuster drug off the market 143 clinical trials. moreover, pharmaceutical company proponents argue that it is unrealistic to expect a drug to be tested for every possible side effect and ad­ verse event because there are too many different scenarios under which a drug may be ingested by the average patient. furthermore, each patient's body re­ acts differently to a drug; an adverse event in one patient may not be found in another. nevertheless, most litigation is still directed towards the pharmaceuti­ cal company when a drug is withdrawn from the market because it is the party that marketed and distributed the failed product. thus, it can be argued that just as a pharmaceutical company takes credit for a successful novel medicine and as a result reaps the financial rewards, it must also be held accountable and publicly responsible for developing and marketing an unsafe drug in order to prevent companies from submitting drugs to the market that have not been thor­ oughly tested. b. to what extent is the fda at fault? another visible party who does not escape liability for its failure to ade­ quately monitor the safety issues associated with a withdrawn drug is the fda. often times, medical experts and insiders within the fda will publicly ridicule the fda for a lack of sustained scrutiny of certain pharmaceutical drugs after these drugs have been approved for sale and distribution in the u.s. market. for instance, during the very public vioxx senate hearings, doctor david gra­ ham testified that the fda failed in its attempt to protect the american con­ sumer from unsafe drugs and that as a result, thousands of americans suffered cardiovascular events that may have been avoided.150 other experts have also testified that the fda has pandered to the interests of the "big pharma" and as a result has failed to objectively regulate the introduction of new drugs on the market.151 this kind of public ridicule and testimony by respected members of the medical profession is extremely damaging, especially to a regulatory agency charged with protecting u.s. citizens from harmful products, and it could lead to future congressional action and examination into drug approval practices.152 150 see risa l. lieberwitz. education law: the corporatization of academic research: whose interests are served?, 38 akron l. rev. 759, 768 (2005); see also lisa richwine, fda failed public on vioxx, reuters, nov. 18, 2004, available athttp://www.lexisnexis.com (click on news and business, click on individual publications, click on r, click on reuters news). 151 lieberwitz, supra note 150, at 768-69. during the vioxx house committee hearings, minnesota congressman gil gutknecht commented, "[j]ust who is the fda protecting, and what are the ethical responsibilities of pharmaceutical companies? both the fda and the phar­ maceutical company sort of missed the mark." bernadette tansey, v"wxx: how marketing drives the pharmaceutical industry: firm misled doctors on vioxx, panel says sales stajjtold not to discuss risk study, s. f. chronicle, may 6, 2005, at ai. 152 see evaluating the effectiveness of the food and drug admin. modernization act beforethesubcomm. onhealthoftheh. comm. onenergyandcommerce,i01thcong.51,at 16-17 (2001) (statement ofw.j. "billy" tauzin, chairman, committee on energy and com­ merce). tauzin, the chairman of the committee on energy and commerce, was optimistic 144 indiana realm law review [vol. 4:115 c. to what extent is the health care professional at fault? while the pharmaceutical company and the fda share the brunt of the blame, in some cases, other smaller groups are also blamed for failing to ade­ quately warn. some claim that the onus falls on the doctor to adequately treat his or her patients and, as a result, to choose the medicine that is right for each individual patient. in most cases, however, physicians will prescribe a drug even with the knowledge that it has certain adverse side effects because the in­ formation available to them, from medical journals and clinical trials outlined in the drug's prescribing information, describes the risk of any adverse event occurring as miniscule; as a result, the benefit to the patient exceeds the health risk posed by such a drug. thus, it is difficult to blame physicians for using the information proffered by the respective pharmaceutical company claiming that the drug is safe in making informed decisions regarding the health of their pa­ tients. conversely, many physician advocacy groups blame the vharmaceutical companies' desire to gain the most market share and revenues. 53 they claim that the pharmaceutical companies continually mislead physicians by feeding them erroneous information through their sales representatives or failing to dis­ close vital information refsarding the drug's safety.154 for instance, during the vioxx senate hearings, 1 critics claimed that merck purposely misled physi­ cians by compensating their sales representatives with a bonus program, which provided the representatives with an incentive not to disclose fully vioxx's safety issues in an effort to increase the drug's market share.156 this program allegedly directed representatives to find ways to avoid safety related questions from physicians and handle these "obstacles" before reverting to the message promoting the drug's efficacy.157 in response to such criticism, a merck about the changes at the fda over the years, but also warned that "approval times have been cut in half, and the percentage of new drugs being introduced in the united states before being in­ troduced in other countries has nearly doubled." id 153 see, e.g., id. at 82-87 (statement of abbeys. meyers, president, the national organi­ zation of rare disorders) (discussing problems with the prescription drog user fee act). 154 tansey, supra note 151. iss id. representative henry waxman (democrat) of los angeles, california, stated at a hearing of the house government reform committee that vioxx "built up sales topping $2 billion during a period when safety concerns were mounting among scientific experts and fed­ eral regulators." i d. representative waxman, whose staff analyzed 20,000 documents related to the sales promotion ofvi!>xx, also claimed that physicians wrote millions ofvioxx prescriptions due to ''merck sales strategies that amounted to 'disinformation and censorship'." id. 1s6 /d. is? id. in addition, the committee analysis found that sales representatives were not to initiate discussions of the vioxx vigor study with physicians and "[i]nstead, they were to offer information from a company-prepared 'cardiovascular card' that indicated vioxx was eight to [eleven] times safer than other anti-inflammatory painkillers." /d. the vigor study showed that although efficacious, vioxx did have a higher risk of causing cardiovascular events than naproxen. press release, peters. kim, president, merck research laboratories (oct. 13, 2004), available at http://www.merck.com/newsroomlvioxx_withdrawal 2007] pulling a blockbuster drug off the market 145 spokesman further reiterated that the company's marketing practices were fair and balanced, noting that ihysicians have the opportunity to read every clinical study including vioxx. 1 8 fu addition, these sales practices are common throughout the pharmaceutical industry where sales representatives attempt to persuade busy physicians to use their products and as a result often fail to be objective. nevertheless, the fda found that merck's sales practices were legal and appropriate. 159 d. shared culpability among all parties involved? inevitably, the party solely responsible for a drug withdrawal is not easily discerned. as evidenced by the vioxx case and other recent drug withdrawals, it is usually a combination of missteps by both the drug's manufacturer and the fda. ultimately, it is difficult to assess blame but easy to identify those who are adversely affected. for instance, it may be the patients who relied on the information provided to them by doctors. additionally, it may be the doctor who relied on information provided to him or her by the pharmaceutical com­ pany. finally, it may be the pharmaceutical company and the appropriate regu­ latory agency that were unaware of the dangers of a drug that had not yet been fully investigated. viti. possible solutions there are several possible solutions in order to minimize the numerous ways in which a drug withdrawal may affect multiple parties. first, although a drug may negatively affect certain patients, other patients who are positively affected by the drug are faced with a lesser quality of life as a result of the drug withdrawal. these patients might be able to fmd some relief if the withdrawn drug could still be prescribed to them. for instance, in the vigor trial, vioxx was administered to 4,000 patients, some elderly, at the highest possible dose of fifty milligrams.160 most patients who were prescribed vioxx, however, were often younger patients and were prescribed much lower doses, specifically at 12.5 and 25 milligrams.161 therefore, many of the patients who were previ­ ously prescribed vioxx did not fall into the category of patients who experi­ enced problems in the vigor trial and arguably should be allowed to continue using it at the lower dose. /pd£11 0 _13 _ 2004 _psk.pdf. 158 tansey, supra note 151. 159 id. 160 letter from thomas w. abrams, dir. of div. of drug marketing, adver., & commc'ns, u.s. dep't health & human servs., to raymond v. gilmartin, president and ceo ofmerck & co. inc. (sept. 17, 2001), http://www.fda.gov/foilwaming_letters/gl751d.pdf. 161 fda.gov, vioxx (rofecoxib tablets and oral suspension), http://www.fda.gov /medwatch!safety /2002/vioxx _ pi.pdf (last visited feb. 24, 2007) (prescribing information circular). 146 indiana health law review [vol. 4:115 in fact, several months after vioxx was withdrawn from the market, a joint advisory committee of the fda, including thirty-two experts, concluded that vioxx should be permitted to reenter the market with a stronger wam­ ing.162 the committee put forth such a recommendation because it concluded that in certain patient populations, the benefits may outweigh the risk:s. 163 a. allow the withdrawn drug to reenter the market under restricted conditions there has only been one case in u.s. history where a drug that was previ­ ously withdrawn from the market was allowed to reenter. in 2000, glaxo phar­ maceuticals introduced lotronex, which treated irritable bowel syndrome and as a result helped millions of americans inflicted with this.painful illness.164 just nine months after it had received fda approval, however, the drug was connected with the deaths of seven individuals, and it was pulled from the mar­ ket.165 nevertheless, after heavy lobbying from desperate patients claiming it to be the only drug that ever relieved their constant misery, the fda permitted glaxo to reintroduce the drug into the u.s. market under careful scrutiny and only if the company agreed to increased monitoring.166 currently, "lotronex may be prescribed only by certain doctors enrolled in a special program, and given only to the sickest patients fewer than 5% of sufferers who have failed other therapies."167 the lotronex incident proved that a withdrawn drug may be allowed to reenter the market under careful scrutiny because certain patient demographics whose quality of life is negatively affected by the drug's withdrawal may suffer less harm with the drug than without it. nonetheless, the manner in which the drug will be tested and scrutinized must be carefully evaluated before the drug can be placed back on the market. also, the fda must conclusively find that the drug is safe for the patient populations that would be allowed to use the drug. finally, the fda must still be willing to re-pull the drug back off the market if there is even a remote chance that the drug will pose any health risk to these patients. 162 vioxx could be sold again, supra note 143. a stronger warning may be in the form of a black box warning, which is placed in the drug's prescribing information regarding a possi­ ble adverse side effect from use of the drug. other such warnings also include "dear doctor,. letters, whereby the fda informs any prescribing physician of the possible dangers associated with the drug in question. 163 !d. 164 bowel drug returns to market with restrictions, usa today, june 7, 2002, http://www.usatoday.com/newslhealth/2002-06-07-bowel-drug.htm. 165 !d. 166 !d. 167 !d. 2007] pulling a blockbuster drug off the market 147 b. create medical liability review panels in order to reduce the number of frivolous lawsuits usually, after a drug is withdrawn from the market, plaintiffs' attorneys create a public hysteria of sorts by soliciting past users of the drug. as a result, many frivolous lawsuits are filed, costing the pharmaceutical company millions of dollars in litigation costs and negative publicity. in order to reduce the num­ ber of frivolous lawsuits that are filed, many states either require or permit that the claim first be submitted to a medical liability review panel that will deter­ mine the credibility of the claim and whether standing may be established in order to further pursue litigation.168 this approach, requiring submission of cases to review panels consisting of doctors and lawyers, was first enacted b~ a number of state legislatures in order to "aid the early settlement of cases." 69 as a result, the state legislature will ensure that the court's time is not being wasted and that pharmaceutical companies are not subjected to the added costs of defending against frivolous claims. c. create an independent drug monitoring board another possible preventive solution is to institute a drug monitoring board independent of the fda.170 this board would only be in charge of moni­ toring drug safety for high volume drugs on the market. it would monitor the appropriate clinical trials and submit reports to both the fda and phrma in order to ensure compliance with recommendations. nevertheless, the goal of such a board would be to decrease the fda's workload and create an inde­ pendent body, detached from the pharmaceutical industry and the fda, that would be able to monitor objectively pharmaceutical drugs from beyond the reach of pharmaceutical lobbyists. 171 this board could also ensure that money is being spent on improving existing products. as the president of phrma, alan f. holmer, stated during his congressional testimony: the industry is spending more than $30 billion annually on research and development [referring to the 2002 year], with about eighty percent of this investment dedi­ cated to the advancement of scientific knowledge and the development of products, compared to about twenty percent that is devoted to improving and/or modifying 168 frank p. grad, medical malpractice and the crisis of insurance availability: the waning options, 36 case w. res. 1058, 1082 (1986). 169 jd. 170 jerry a vorn, powerful medicines: the benefits, risks, and costs of prescription drugs 373 (2004). 171 matthew harper, david graham on the vioxx verdict, forbes.com, aug. 19, 2005, http://www.vioxx-recall-lawsuit.com/news/graham.pdf. 148 indiana health law revjew [vol. 4:115 . . rod 172 existing p ucts. currently, the fda is charged with monitoring more than 10,000 drugs, in addition to performing other re~duties such as new drug approval and post-approval marketing surveillance.1 an independent monitoring board would therefore mean that there are some checks and balances in the system and would allow for closer scrutiny of post-approval clinical studies. therefore, there are several possible solutions to reduce the devastating impact such withdrawals have on all the affected parties. ix. conclusion the pharmaceutical industry has played a prevalent role in both united states and world history. pharmaceutical companies have been credited with eliminating many diseases through the introduction of novel medicines and, as a result, are helping to increase life expectancy rates throughout the world. in order to continue to develop novel medicines, however, pharmaceutical compa­ nies place a great deal of emphasis on research and development research and development cost a company millions of dollars every year in its search for the next blockbuster drug. much expense is placed on obtaining the best and brightest scientists and providing them with the requisite resources to produce a blockbuster drug. in order to provide scientists with the resources required to produce the next blockbuster drug, a pharmaceutical company must gain suffi­ cient revenue from its existing pipeline of drugs. hence, a cycle in which a company is forced to produce blockbuster drugs in order to offset the costs of previous blockbuster drugs. today, pharmaceutical conglomerates are bigger than ever. presently, more money is spent on obtaining the brightest executives and providing sales personnel with all the resources necessary to obtain the greatest possible market share in this very competitive industry. the company depends on a strong pipe­ line of drugs that will provide a continual stream of revenues and profits for this purpose as well. this stream of revenues and profits is required in order for the company to produce novel medicines. as a result ofbeing a player in a very competitive industry, pharmaceuti­ cal companies in the united states have the dual objective of providing afford­ able health care to the general public and making a profit for their shareholders. as consumers have demanded more affordable medicines, pharmaceutical companies and the fda have developed an increasingly cozy relationship and, as a result, have put the public at risk. 174 this is a contentious proposal for 172 goozner, supra note 12, at 235. 173 see michelle meadows, why drugs get pulled off the market, fda consumer, jan.-feb. 2002, at 11, 11-17, http://www.fda.gov/fdac/features/2002/1 02 _ drug.htrnl. 174 see, e.g., eric j. topol, failing the public health rofecoxib, merck, and the fda, 2007] pulling a blockbuster drug off the market 149 many pharmaceutical executives, knowing that they are only as secure as the next dividend payment to their shareholders. therefore, such executives must produce more profitable blockbuster drugs or else find other employment. the continual desire to produce the next great blockbuster drug can lead to many legal, business, and ethical problems. as a result, when a pharmaceu­ tical company produces a blockbuster drug that is later pulled off the market because of safety concerns, the question arises as to whether the lure of making a profit blinded the company into approving a drug wrought with safety issues. regardless of the circumstances prompting a company to pull a drug off the market, the ramifications of such a decision can affect all involved, including company employees, physicians, patients, and the appropriate regulatory agen­ cies. the legal, business, and ethical ramifications of pulling a drug off the market can be severe. this removal can cost the company millions of dollars in litigation as a result of the multitude oflawsuits brought by the alleged victim­ ized plaintiffs claiming that the company produced an unsafe product. 175 the costs of a drug withdrawal can affect the company in more ways than just its bottom line. for instance, it can affect a pharmaceutical company's perception on wall street and, as a result, affect investor confidence. since most large pharmaceutical conglomerates are traded on publicly accessible stock ex­ changes, a major drug withdrawal can cause a decrease in stock price. there­ fore, the loss in investor confidence ultimately leads to a variety of changes within the respective pharmaceutical company. restructuring leadership posi­ tions can include layoffs and termination of many executive positions. finally, there are significant ethical questions to be answered after a drug has been withdrawn from the market. specifically, how are patients to cope when they have depended on the withdrawn drug to provide them with a quality of life that they did not possess prior to the drug's introduction in the market­ place? moreover, when did the fda and the respective pharmaceutical com­ pany know of the drug's safety issues and was the response swift and appropriate? the ideal solution would be for the pharmaceutical companies to take these questions into account both prior to marketing the blockbuster drug and every step of the way after initially marketing it. after examining the different parties affected by a drug withdrawal, there is no one party who is clearly culpable. although at first it seems as if the pharmaceutical company must be blamed, 176 in essence, there are many parties that are blameworthy. to solely blame one party over another, however, would be erroneous because, ultimately, the parties negatively affected by a drug 351 new eng. j. med. 1707, 1707-09 (2004); thomas l. friedman, the world is fiat: a brief history of the twenty-first century 252 (2006). 175 on the other hand, patients who were negatively affected by the drug must spend con­ siderable time and money to sue a defendant who more often has considerably greater resources. 176 see generally barry werth, the billion dollar molecule: one company's quest for the perfect drug (1994) (illustrating the importance that a company places on profits and finding the next blockbuster drug). 150 indiana health law review [vol. 4:115 withdrawal are also those in fervent support of developing and distributing ef­ fective drugs. microsoft word 1-masthead vol. viii.doc mary j. davis mary j. davis is the stites & harbison professor of law and associate dean for academic affairs at the university of kentucky college of law. she joined the faculty of the university of kentucky in 1991 after six years of a litigation defense practice, predominantly in products liability. she writes in the products liability field and is co-author of the textbook, products liability and safety: cases & materials (6th ed. 2010) (with owen and montgomery). she is currently working on a multi-volume products liability treatise, owen and davis, the law of products liability (forthcoming 2012). her articles on federal preemption have contributed extensively to the drug preemption debate, including articles published in the hastings law journal, boston college law review, university of pittsburgh law review, among others. she has been a visiting professor of law at the university of texas school of law, boston college law school, william and mary college of law and wake forest university school of law. she is a 1985 magna cum laude graduate of the wake forest school of law, where she served as managing editor of the law review, and a 1979 cum laude graduate of the university of virginia. she is an elected member of the american law institute where she has served on the members consultative groups for the restatement (third) of torts and aggregate litigation projects. the case against preemption: vaccines & uncertainty mary j. davis* i. introduction ............................................................................... 293 ii. modern preemption framework ............................................. 296 iii. a few lessons from implied preemption and wyeth v. levine ............................................................................. 303 iv. synthesis of preemption analysis .......................................... 306 v. vaccine act preemption: bruesewitz v. wyeth llc ............. 307 vi. the role of uncertainty .......................................................... 314 i. introduction proponents of expansive federal preemption of state law damages actions begin their critique of state law with the following: federal regulatory bodies, not common law juries, have the expertise to decide the correct balance of risk and benefit that regulated industries should be permitted to pose to the general public. once a federal agency has decided through the appropriate regulatory structure that a certain drug is approved or a certain product design is permissible, state juries should not be permitted to second-guess that decision. federal preemption must operate to defeat the inconsistent actions of state juries because they have neither the expertise to understand the complex factors at issue in such a balancing act, nor the ability to see beyond the individual injured plaintiff, or so the argument goes.1 this argument has been made successfully over the past twenty years in a wide variety of product liability actions involving drugs and medical devices.2 the structure and content of the federal preemption doctrine has * stites and harbison professor of law, associate dean for academic affairs, university of kentucky college of law. thanks to dan hancock, uk law class of 2011, for his superb research assistance in support of this article and to the university of kentucky college of law summer research grant program for its support. thanks also to the aals torts and compensation systems section leaders, in particular prof. cathy sharkey, for the opportunity to participate in this panel discussion at the 2011 aals annual meeting. 1. see riegel v. medtronic, inc., 552 u.s. 312, 325 (2008) (“a jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; . . . .”). see generally, richard c. ausness, the impact of wyeth v. levine on fda regulation of prescription drugs, 65 food & drug l.j. 247, 253-59 (2010) (discussing the pro and con preemption arguments in the context of prescription drug labeling before wyeth v. levine). 2. medtronic, inc. v. lohr, 518 u.s. 470 (1996); bucknam v. plaintiffs legal committee, 531 u.s. 341 (2001); riegel v. medtronic, inc., 552 u.s. 312 (2008); wyeth, inc. v. levine, 129 s.ct. 1187 (2010). at the time of the presentation of the aals panel on the topic of federal preemption in the vaccine injury context, the supreme court had not yet 294 indiana health law review [vol. 8:2 changed remarkably in that time period.3 from a time of rare findings of federal preemption of state damages actions4 to the now constant drum beat of the pro-preemption argument in virtually any tort damages action that involves a regulated entity, particularly in the health care field,5 the question of whether common law tort doctrines should continue to play a role in the regulatory framework is more important than ever―i have elsewhere articulated a number of reasons why i conclude that it should.6 the most important of these is the need for an alternative, complementary mechanism to the typically static administrative regulatory framework to encourage the disclosure of, and promote responses to, constantly evolving risk information. the longstanding role of the states in regulating public health and safety, coupled with the inherent inadequacy of any current federal regulatory agency to police fully the acquisition of and proper dissemination of risk information, supports that conclusion.7 the national childhood vaccine injury act8 (“vaccine act”), which is the subject of these remarks, provides a unique administrative structure to form the backdrop for this argument. the vaccine act established a national vaccine program “for the development of new vaccines and the improvement of existing vaccines and a program to compensate the victims of vaccine-related injuries and deaths.”9 congress established a “no-fault” compensation system under which awards “can be made to vaccine-injured persons quickly, easily, and with certainty and generosity.”10 the compensation program (“program”) is the first step for those who suffer vaccinerelated injuries because the vaccine act also permits some claims that do decided the preemption case involving the national childhood vaccine injury act of 1986. bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011). the court decided the case on february 28, 2011 in favor of preemption. id. 3. for explanations of the changes in preemption doctrine over the past decades, see generally mary j. davis, the “new” presumption against preemption, 61 hastings l. j. 1217 (2010); catherine m. sharkey, products liability preemption: an institutional approach, 76 geo. wash. l. rev. 449 (2008); mary j. davis, unmasking the presumption in favor of preemption, 53 s.c. l. rev. 967 (2002). 4. see, e.g., abbott v. american cyanamid co., 844 f.2d 1108 (4th cir. 1988) (dtp vaccine); macdonald v. ortho pharm. corp., 475 n.e.2d 65 (mass. 1985) (birth control pills). see also david g. owen, products liability 909 (2d ed. 2010). 5. see owen, supra note 4. 6. mary j. davis, the battle over implied preemption: products liability and the fda, 48 b.c. l. rev. 1089, 1148-51 (2008). see also mary j. davis, on restating products liability preemption, 74 brook. l. rev. 759, 776-79 (2009). 7. for others who arrive at a similar conclusion, see elizabeth cabraser, due process preempted: stealth preemption as a consequence of agency capture, 65 n.y.u. ann. surv. of am. l. 449 (2009). 8. national childhood vaccine injury act, pub. l. no. 99-660, 100 stat. 3743, 375684 (codified at 42 u.s.c. §§ 300aa-1 to 300aa-34) (1987). see generally lainie rutkow, et al., balancing consumer and industry interests in public health: the national vaccine injury compensation program and its influence during the last two decades, 111 penn st. l. rev. 681 (2007). 9. h.r. rep. no. 99-908 at 1 (1986), reprinted in 1986 u.s.c.c.a.n. 6344, 6344. 10. id. 2011] the case against preemption: vaccines & uncertainty 295 not lead to program compensation to proceed in the traditional way—a civil action for damages “just as he or she may have done prior to the enactment of the legislation.”11 congress expressly preempted some tort claims in the vaccine act.12 the question is: which ones? and, more importantly, should such a legislative directive be expected to respond to the natural evolution of scientific understanding of the regulated risk, and, if so, how? current express preemption doctrine, which requires an assessment of congressional intent as the “ultimate touchstone of preemption analysis,”13 has not fully explored that question. one component of preemption analysis, the “presumption against preemption,” which has fallen into disfavor at the supreme court,14 seems to accommodate the need to consider changes in scientific understanding of risk. when the presumption against preemption is properly understood, it requires an understanding of the tort system as uniquely equipped to respond to the uncertainty inherent in the understanding of risk. one way to frame this important question was articulated recently by judge guido calabresi of the unites states court of appeals for the second circuit, a long-time prominent tort law scholar.15 in his opening remarks for a symposium titled “tort law in the shadow of agency preemption,” judge calabresi articulated the core issues tort law faces in a world increasingly dominated by administrative regulatory action: (1) “does national centralized decision-making, as between safety and accidents—and as to who bears the cost of safety or the cost of accidents—work better than local, diverse, and diffuse decision-making?;”16 (2) “what are the benefits of allowing different local decisions? how often in america do we have and want to have different values, different notions of what life is worth, of what things are worth?;”17 and (3) “what does the difference between localized and centralized decision-making tell us about who bears the burden of these decisions?”18 this article provides a small contribution to these much larger questions by asking how courts should respond to the evolution of scientific understanding of risk in determining who bears the cost of that risk when assessing congressional intent to preempt traditional state com 11. id. several new substantive and procedural requirements were established for the recovery of these damages. id. 12. 42 u.s.c. § 300 aa-22 (1987). this provision’s scope has been in issue in recent litigation. the supreme court decided that the provision preempted all design defect litigation in bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011). for a fuller discussion of bruesewitz, see supra notes and accompanying text. 13. white motor co. v. malone, 435 u.s. 497, 504 (1978). 14. see davis, the “new” presumption, supra note 3, at 1220. 15. hon. guido calabresi, keynote address at the new york univ. annual survey of american law: tort law in the shadow of agency preemption, 65 n.y.u. ann. surv. am. l. 435 (2009). 16. id. 17. id. 18. id. 296 indiana health law review [vol. 8:2 mon law. first, this article provides a brief recap of the state of current preemption doctrine and how it governs the interaction of federal regulation of product manufacturers and state tort actions related to the actions of those manufacturers. second, the article provides observations on how that doctrine might apply to vaccine injury litigation. bruesewitz v. wyeth, inc.19 involves the preemptive scope of the vaccine act and the unique compensation system congress created to respond to vaccine injuries. bruesewitz was decided on february 22, 2011, and held that design defect claims are expressly preempted by the vaccine act.20 this article endeavors to explain bruesewitz in the context of express preemption doctrine generally. this article also provides observations on the continuing value of state tort law in the assessment of unreasonable risk. finally, comments in response to judge calabresi’s framing question, asking how to address the uncertainty inherent in acquisition of risk information, will build on the preemption analysis from bruesewitz to encourage a narrow application of the scope of preemption doctrine particularly in the case of pharmaceuticals and medical devices. ii. modern preemption framework preemption doctrine requires, under the supremacy clause, that courts search for congressional intent to preempt as the ultimate touchstone of preemption analysis.21 express preemption provisions are to be mined for their meaning and scope and in the absence of such a provision, limited doctrines of implied preemption act as gap-fillers where congress’s intent can be presumed based on an actual conflict with state law.22 the presumption against preemption is one feature of preemption analysis that requires a nuanced understanding. historically, the presumption requires the conclusion that, absent clear and manifest congressional intent to the contrary, state common law tort actions―as a reflection of the historic police powers of the states―are not preempted by federal regulatory action.23 congress must be presumed not to displace such actions out of respect for the concurrent, traditional operation of state police powers. this presumption has been described as a fundamental reflection of federalism principles that prevents preemption analysis from becoming a tool of the 19. bruesewitz v. wyeth, inc., 561 f.3d 233 (3d cir. 2009), aff’d, 131 s. ct. 1068 (2011). 20. id. 21. u.s. const. art. vi, cl. 2; retail clerks int’l ass’n, local 1625 v. schermerhorn, 375 u.s. 96, 103 (1963). 22. see davis, the “new” presumption, supra note 3, at 1221. 23. see wyeth v. levine, 129 s. ct. 1187, 1194 (2009). see also davis, the “new” presumption, supra note 3. 2011] the case against preemption: vaccines & uncertainty 297 courts or agencies—any branch other than congress—to assess preemptive scope in some freewheeling fashion to displace otherwise applicable state law, regardless of the perceived value or popularity of that law.24 the supreme court’s preemption decisions in the last twenty years have introduced substantial confusion regarding the preemption framework generally and the application of the presumption against preemption specifically. as a result, it seems that there is a tendency for courts to view the topic of preemption very narrowly and to lose many of the nuances that are involved, but that is the world in which courts operate. courts are looking for a model, a rational framework by which to answer these intractable questions surrounding the concurrent application of state law in an increasingly federalized world of tort duties and obligations. so when the supreme court decides a case like cipollone v. the liggett group, inc.,25 which found preemption of some common law tort claims based on the federal cigarette labeling laws prohibition of conflicting state law “requirements,”26 lower courts, based on expansive pro-preemption arguments of product manufacturers, tended to find other legislative enactments that referred to “requirements” as broadly preemptive in scope.27 cipollone actually articulated a narrow construction of express preemption provisions in light of the presumption against preemption, but the justices disagreed strongly on the nature of that analysis.28 i continue to think that cipollone’s determination that “requirements” include common law damages actions in the cigarette labeling statute was misguided. that genie is out of the bottle, however, and the court has continued to hold that the use of the word “requirements” may indicate congressional intent to defeat common law damages actions.29 the ensuing turmoil over how to determine the scope of express preemption provisions has led to a hodge-podge of confusing, sometimes conflicting, preemption decisions. the court’s next preemption opinion, medtronic, inc. v. lohr,30 also focused on express preemption, this time under the medical device amendments (“mda”) to the food, drug and cosmetic act (“fdca”), 24. see, e.g., wyeth, 129 s. ct. at 1205 (justice thomas, concurring, criticizing freewheeling judicial assessment under implied obstacle preemption); see also brief for kenneth starr and erwin chemerinsky as amici curiae supporting petitioner, bruesewitz v. wyeth, 131 s.ct. 1068 (2011) (no. 09-142). 25. cipollone v. the liggett group, inc., 505 u.s. 504 (1992). 26. id. at 515-20. 27. see medtronic, inc. v. lohr, 518 u.s. 470, 483-87 (1996) (discussing the treatment by courts of the term “requirements” in the mda to the fdca, and concluding nothing in the legislation or its history suggested that common law damages actions were intended to be requirements). 28. cipollone, 505 u.s. at 518. 29. riegel v. medtronic, inc., 552 u.s. 312, 325 (2008). see also robert rabin, territorial claims in the domain of accidental harm: conflicting conceptions of tort preemption, 74 brook. l. rev. 987, 991-994 (2009) (discussing tort duties as “requirements”). 30. lohr, 518 u.s. 470 (1996). 298 indiana health law review [vol. 8:2 which preempted state law “requirements.” plaintiff alleged common law product defect claims arising out of his use of defendant’s pacemaker, which had been approved under the fda’s pre-market notification approval regulations, a grandfathering method of approval without the heightened rigor of the more elaborate pre-market approval process.31 the court was divided on whether the mda preempted the plaintiffs’ claims, but all justices again agreed that the express preemption provision controlled the analysis.32 the majority opinion applied the presumption against preemption and, in doing so, concluded that common law damages actions alleging design defects did not impose “requirements” in this context.33 four justices concluded that nothing in the legislation, its history, or its basic purpose suggested that common law damages actions were intended to be requirements.34 importantly, a majority of justices concluded in lohr that, while general common law obligations were not a threat to the non-device specific federal requirements at issue,35 where the federal government had weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or products, an entirely different case would exist for preemption under the statute and implementing regulations.36 the search for specific federal government “weighing of competing interests” in subsequent regulatory situations becomes a recurring theme in assessing preemption, both express and implied.37 31. id. at 476-81. 32. id. at 484-85; id. at 503 (breyer, j., concurring); id. at 509 (o’connor, j., concurring and dissenting). 33. id. at 476-81. justice stevens wrote: “[w]e used a presumption against the preemption of state police power regulations to support a narrow interpretation of such an express command in cipollone. that approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety.” id. at 485. 34. id. at 487. 35. id. at 501-02. 36. id. at 501. justice breyer’s concurring opinion gave the court its judgment in the case, and he interpreted the word “requirement” to include common law damages actions in some circumstances, but not in this case. id. at 503-05. 37. id. the court also addressed the fda’s preemption position articulated in a formally adopted regulation that implemented its statutory preemption authority. id. at 497-98. see also 21 c.f.r. § 808.1(d)(2) (2008) (no preemption of state or local requirements that are “equal to, or substantially identical to, requirements imposed”); 21 c.f.r. § 808.1 (d)(1) (no preemption of “state or local requirements of general applicability”). federal agency action regarding preemption may inform preemptive scope if congress has delegated to the agency that authority. the justices disagreed on the extent to which they should rely on an agency’s position on preemption, though in earlier cases the court had noted that agency regulations could be informative on defining the scope of preemption where consistent with statutory language. see csx transp. inc. v. easterwood, 507 u.s. 658, 670 (1993); norfolk & southern ry. v. shanklin, 529 u.s. 344 (2000) (preemption under federal railroad safety 2011] the case against preemption: vaccines & uncertainty 299 a few years after lohr, the court decided the effect of an express preemption provision in the national traffic and motor vehicle safety (“ntmvsa”) in geier v. american honda motor corp.38 the case involved an allegedly defective automobile that did not have a driver’s side airbag even though the federal motor vehicle safety standard 208 permitted manufacturers at the time to choose whether to incorporate such safety systems.39 geier, which found implied but not express preemption even though the statute contained an express preemption provision, is a watershed case in the court’s preemption opinions because of its expansive implied preemption analysis. it reflects the power of federal administrative agency position regarding preemption if that position is based on an assessment of whether an actual conflict would “take from those who would enforce a federal law the very ability to achieve the law’s congressionally mandated objectives that the constitution, through the operation of ordinary preemption principles, seeks to protect.”40 the court was persuaded in geier to apply implied conflict preemption principles out of concern for the “careful regulatory scheme” established by ntmvsa, despite the arguably plain meaning of the savings clause. the court’s treatment of common law damages actions in geier illustrates the court’s uncertainty about the value of traditional state law’s regulatory value, even in cases where preemption is being implied. the geier court perceived that common law tort actions might be detrimental to thoughtfully established federal goals,41 even in the face of congressional intent to the contrary as evidenced by the savings clause. the court weighed the perceived federal regulatory objectives against the general interest the states have in promoting health and welfare and compensating citizens for injuries suffered by defective products.42 it was somewhat sympathetic to state concerns of compensating victims and enhancing product safety, but concluded that jury-assessed standards would lead to unpredictability and uncertainty in the standard of care.43 the court did not mention the presumption against preemption.44 the geier analysis, which broadly assessed federal objectives under implied preemption analysis, has act, relevance of agency position debated). 38. geier v. american honda motor corp., 529 u.s. 861 (2000). geier is a five-tofour opinion; justice breyer writing for the majority, joined by chief justice rehnquist, justices o’connor, scalia, and kennedy. justice stevens, the author of both the cipollone and medtronic plurality opinions, dissented in an opinion in which justices souter, thomas, and ginsberg joined. 39. id. at 865. the national traffic and motor vehicle safety act of 1966, pub. l. no. 89-563, 80 stat. 718 (codified as amended at 49 u.s.c. 30101-30169). 40. geier, 529 u.s. at 872. 41. id. at 881. see also medtronic, inc. v. lohr, 518 u.s. 470 (1996). 42. geier, 529 u.s. at 882-83. 43. id. at 871. 44. id. at 894 (stevens, j. dissenting). 300 indiana health law review [vol. 8:2 been criticized for its potential to encourage judicial over-reaching of state law prerogatives.45 the court has also relied variously on the federal government’s position on preemption, either through agency action or government litigating position, to establish intent to preempt. lohr involved a specific agency rule promulgated to define the scope of the mda preemption provision prior to litigation and the court was “substantially informed” by it.46 the government’s position in geier was found in a wide-ranging assessment of the history of the regulation and the current secretary’s position in the litigation as well as predecessor secretary’s opinions.47 in the eight years between cipollone and geier, the court contracted the operation of traditional state tort laws substantially and therefore increased the likelihood that propreemption arguments would be made based on federal regulatory action. the court also resisted discussing the presumption against preemption and increasingly relied on agency assessments of the role of state tort law as complementary to federal regulatory action.48 subsequent cases display the court’s own unease in assessing the scope of express preemption provisions. in bates v. dow agrosciences llc,49 the court spoke openly about the delicate balance that must be achieved in determining the scope of express preemption provisions, and about the effect of shifting agency position on that analysis. bates involved preemption under the federal fungicide, insecticide and rodenticide act (“fifra”) and failure to warn claims regarding pesticides whose labels 45. indeed, the court recently decided a second ntmvsa case involving standard 208 and found that the regulatory history did not impliedly preempt a common law damages claim involving rear lap seat belts. williamson v. mazda motor of am., inc., 131 s. ct. 1131 (2011). in williamson, the court speaking through justice breyer who authored geier, concluded that state tort law did not actually conflict with the then current version of standard 208 because there was no indication that the federal agency intended to prevent states from “supplement[ing] through state tort law” federal minimum standards. id. at 1139. see also, id. at 1140 (sotomayor, j., concurring) (“i write separately only to emphasize the court’s rejection of an overreading of geier that has developed since that opinion was issued.”). 46. medtronic, inc. v. lohr, 518 u.s. 470, 495-96 (1996). justice breyer concurred, agreeing that “the relevant administrative agency possesse[d] a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect.” id. at 505-06 (breyer, j., concurring). 47. geier, 529 u.s. at 883. 48. an example is sprietsma v. mercury marine involving coast guard action under the federal boat safety act. 537 u.s. 51, 59-60 (2002) (applying 46 u.s.c. §§ 4301-11 (2000)). the court was faced with whether a coast guard decision not to regulate the design of propeller guards preempted common law claims based on a failure to equip with propeller guards, and found neither express nor implied conflict preemption. id. at 64-66. the court was influenced by coast guard regulations, which preserved state authority in the absence of federal action, and the coast guard consistently concluded that its regulations did not have preemptive effect, though it had no formal rule on the subject. id. at 66. 49. 544 u.s. 431 (2005). bates involved application of the express preemption provision of the federal insecticide, fungicide, and rodenticide act, pub. l. no. 80-103, 61 stat. 163 (1947) (codified at 7 u.s.c. §§ 134-36). 2011] the case against preemption: vaccines & uncertainty 301 were epa.50 the court reiterated, however, its adherence to the presumption against preemption because tort litigation “provide[s] an incentive to manufacturers to use the utmost care in the business of distributing inherently dangerous items.”51 the court narrowly analyzed the express preemption provision, as it had done in cipollone, specifically rejecting the conclusion that common law jury verdicts are the equivalent of “requirements” simply because they may influence decision-making.52 the court also expressed a sense of frustration at the way the lower courts had read the term “requirements” broadly after cipollone, and chastised the “too quick conclusion”53 that tort claims were always preempted under statutes that used that term. the court concluded that the express preemption provision preempted very few claims,54 stating, “if congress had intended to [prevent the operation] of a long available form of compensation, it surely would have expressed that intent more clearly.”55 the court endorsed the parallel operation of common law tort claims, stating they “would seem to aid, rather than hinder, the functioning of fifra . . . [which] contemplates that pesticide labels will evolve over time, as manufacturers gain more information about their products’ performance in diverse settings . . . [t]ort suits can serve as a catalyst in this process.”56 three years later, the court returned to express preemption under the fdca mda. riegel v. medtronic, inc.57 involved allegations of design defect in devices approved through the pre-market approval process.58 the court was quite critical of the role of common law tort claims in regulating product safety, unlike its position in bates, and was quite expansive in its 50. bates, 544 u.s. 431. 51. id. at 449; see also id. at 459 (thomas, j., concurring in part and dissenting in part) (“today’s decision thus comports with this court’s increasing reluctance to expand federal statutes beyond their terms through doctrines of implied preemption. this reluctance reflects that preemption analysis is not [a] freewheeling judicial inquiry into whether a state statute is in tension with federal objectives, . . . but an inquiry into whether the ordinary meanings of state and federal law conflict.” (citations omitted)). 52. id. at 445 (reasoning that “[a] requirement is a rule of law that must be obeyed[, whereas] an event, such as a jury verdict, that merely motivates an optional decision is not a requirement”). 53. id. at 446. 54. id. at 451-52. 55. id. 56. id. (stating that the defendant and epa’s concern that “tort suits led to a ‘crazyquilt’ of fifra standards or otherwise created [a] real hardship for manufacturers” was unpersuasive because, as the court observed, “for much of this period epa appears to have welcomed these tort suits.”). 57. riegel v. medtronic, inc., 128 s. ct. 999 (2008). 58. id. the second mda preemption case was bucknam co. v. plaintiffs’ legal committee involving a so-called fraud-on-the-agency theory that the court found was not expressly preempted by the mda’s express preemption provision but was impliedly preempted because policing fraud on an agency is a uniquely federal matter. 531 u.s. 341 (2001). 302 indiana health law review [vol. 8:2 description of the scope of express preemption.59 the court, speaking through justice scalia, seemed less interested in assessing congressional intent to preempt, which it had done in two prior cases, than in re-affirming its own understanding of the statute’s term “requirements.”60 the court declared that “requirements” includes common law tort claims, stating: “congress is entitled to know what meaning this court will assign to terms regularly used in its enactments. absent other indication, reference to a state’s ‘requirements’ includes its common-law duties.”61 this conclusion, which seems contrary to bates’ analysis and sentiment, is the kind of inconsistency that makes express preemption analysis so fraught with uncertainty. while thus defining the term “requirement” for future congresses, the court reiterated its pre-bates distrust over the operation of common law tort actions. justice stevens, the originator of modern preemption analysis in cipollone, had come to speak positively about the general value of state tort law as a complement to federal regulation, as indicated by his opinion in bates. justice scalia, the author of riegel, on the other hand, finds tort law as applied by juries to be “less deserving of preservation” than other state regulations. his stated rationale is that juries are incapable of balancing costs and benefits adequately as they “see[] only the costs of a more dangerous design, and [are] not concerned with [the] benefits” consumers reap by the manufacturer’s design choices.62 the riegel court found it “implausible” that congress would create the “perverse distinction” that grants greater power to a single state jury than to state officials.63 there is no mention of the “presumption against preemption.” there is certainly little regard in these remarks for tort law’s historic place in contributing to public safety or for its “catalyzing” effect to increase access to risk information as discussed in bates.64 the final pre-bruesewitz express preemption case meriting discussion is altria group, inc. v. good,65 decided after riegel, which involved the 59. 128 s.ct. 999, 1007. 60. id. 61. id. for a different assessment of congress’s intent, see 128 s.ct. 999, 1013 (ginsburg, j., dissenting). justice stevens, the author of cipollone, lohr, sprietsma, and bates, concurred on the scope of “requirements” because he considered it consistent with the result in medtronic, inc. v. lohr, 518 u.s. 470 (1996). 128 s. ct. 999, 1011-13 (stevens, j., concurring in part and dissenting in part). 62. id. at 1007. 63. id. 64. some observers have described riegel as a fairly narrow application of the mda express preemption provision and a logical extension of medtronic, inc. v. lohr, 518 u.s. 470 (1996). see catherine m. sharkey, colloquy, what riegel portends for fda preemption of state law products liability claims, 102 nw. u. l. rev. 415 nn. 3-4 (2008). see contra davis, on restating products liability preemption, supra note 6 (discussing the importance of the debate in riegel to the larger discussion of the continuing value of tort law). 65. 129 s.ct. 538 (2008). 2011] the case against preemption: vaccines & uncertainty 303 continuing validity of cipollone in defining the claims that survived express preemption under the cigarette labeling laws.66 after riegel and its eightto-one opinion in favor (in dicta, at least) of a more expansive reading of express preemption provisions, one would have expected that justice stevens’ plurality opinion in cipollone had been outgrown. on the contrary, the court held that the cipollone plurality controls the express preemption analysis of the statute.67 the majority, authored by justice stevens, rejected the broader scope of preemption analysis proposed by justice scalia in cipollone, and advocated in altria group by justice thomas for the dissent,68 stating, “justice scalia’s approach was rejected by seven members of the court, and in the almost 17 years since cipollone was decided congress has done nothing to indicate its approval of that approach.”69 justice stevens’ opinion confirmed the validity of the presumption against preemption in conjunction with a fair but narrow reading of the scope of express preemption.70 bates, riegel, and altria group, as the most recent express preemption opinions until bruesewitz, give contrary signals about the role of the presumption against preemption and determining the scope of congressional intent to preempt as found in express provisions. justice stevens retired in 2010. a different majority may be about to emerge on the scope of preemption of traditional state tort laws. the bruesewitz contribution to express preemption analysis is found in part iii. iii. a few lessons from implied preemption and wyeth v. levine while implied preemption doctrine is not applicable to vaccine act preemption, the court’s opinion in 2009 in wyeth v. levine,71 which involved the application of implied preemption under the fdca to pharmaceutical labeling claims, is an important contribution to the continuing debate over the value of state tort law in the regulatory framework for pharmaceuticals. the court had not decided an fdca implied preemption case since hillsborough county v. automated medical laboratories, inc.72 in 1985. in addition, the fda which had for years been in favor of the concurrent operation of state common law damages actions had changed its 66. id. at 541-42. 67. id. at 549 (“in sum, we conclude now, as the plurality did in cipollone, that ‘the phrase “based on smoking and health” fairly but narrowly construed does not encompass the more general duty not to make fraudulent statements.’” (quoting cipollone v. liggett group, 505 u.s. 504, 529 (1992)). 68. id. at 545 n.7; see id. at 552-54 (thomas, j., dissenting). 69. id. at 545 n.7 (majority opinion). 70. see id. at 543. 71. wyeth v. levine, 129 s. ct. 1187 (2009). 72. hillsborough county v. automated medical laboratories, inc., 471 u.s. 707 (1985). 304 indiana health law review [vol. 8:2 position on preemption, first in a series of amicus briefs in cases beginning in 2004 and then in a now discredited 2006 preamble to new pharmaceutical labeling regulations.73 a number of issues had confounded the lower courts, which needed guidance on the modern state of implied preemption analysis.74 levine involved the anti-nausea drug phenergan that had been approved in 1955.75 plaintiff lost her arm as a result of inadvertent injection of the migraine drug into an artery, which resulted in gangrene, a risk of which wyeth was aware and which had been warned about in the product’s labeling.76 ms. levine claimed that the labeling inadequately warned of the risk of gangrene, and the jury agreed.77 the vermont supreme court affirmed a lower court ruling that ms. levine’s claims were not impliedly preempted by the fda’s labeling approvals.78 wyeth made two separate implied conflict preemption arguments: first that it would have been impossible for it to comply with the state law duty to warn without violating federal law, and, second, that recognition of the plaintiff’s claims would act as an obstacle to the accomplishment of federal objectives because it substitutes a lay jury’s decision for the expert judgment of the fda.79 the court, again speaking through justice stevens with a six-to-three majority, found that the fda’s product labeling approvals did not impliedly preempt levine’s tort claims under either impossibility or obstacle implied preemption.80 the court re-affirmed the “two cornerstones of our pre-emption jurisprudence” 81 first, that the purpose of congress is the “‘ultimate touchstone in every pre-emption case’” 82 and, second, “in all pre-emption cases,” 83 but particularly those involving fields which the states have traditionally occupied, the analysis begins with the presumption against preemption. the court rejected wyeth’s argument that the presumption should not apply in implied preemption cases, stating, 73. see davis, the battle over implied preemption, supra note 6, at 1090 (chronicling the history of the change in fda preemption policy). the preamble is found in requirements on content and format of labeling for human prescription drug and biological products, 71 fed. reg., 3922, 3934 (jan. 24, 2006). see also catherine m. sharkey, preemption by preamble: federal agencies and the federalization of tort law, 56 depaul l. rev. 227 (2007). 74. see, e.g., colacicco v. apotex, inc., 521 f.3d 253 (3d cir. 2008), vacated by colacicco v. apotex, inc., 129 s. ct. 1578 (u.s. 2009); tucker v. smithkline beecham, 596 f. supp. 2d 1225 (s.d. ind. 2008); knipe v. smithkline beecham, 583 f.supp.2d 553 (e.d. pa. 2008). 75. levine, 129 s.ct. at 1191. 76. id. at 1191-92. 77. id. at 1193. 78. levine v. wyeth, 944 a.2d 179 (vt. 2007). 79. wyeth v. levine, 129 s. ct. at 1193-94. 80. id. at 1190-91. 81. id. at 1194. 82. id. (quoting medtronic, inc. v. lohr, 518 u.s. 470, 485 (1996)). 83. id. (quoting medtronic, inc. v. lohr, 518 u.s. 470, 485 (1996)). 2011] the case against preemption: vaccines & uncertainty 305 “this court has long held to the contrary.”84 the court emphasized that “through many amendments to the fdca and to fda regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.”85 the court required “clear evidence” before an impossible conflict is established.86 there was no evidence that the fda gave more than “passing attention” to the issue and certainly no affirmative decision to prohibit wyeth from strengthening its warning.87 the court’s discussion of implied obstacle conflict preemption principles is important because of the contrast with the discussion in geier. implied obstacle preemption, according to the levine court, requires two things: (1) an identification of the congressional purposes or objectives which support the federal law and, (2) a rigorous assessment of whether congress considered state law claims to pose an obstacle to the accomplishment of those objectives, not just the agency charged with effectuating congress’ intent. borrowing from the successful obstacle conflict preemption analysis in geier, wyeth had argued that levine’s tort claims were preempted because “they interfere with ‘congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.’”88 the court rejected these arguments because they relied on an “untenable interpretation of congressional intent and an overbroad view of an agency’s power to pre-empt state law.”89 relying on an argument that had been successful in geier, wyeth contended that once the fda approves a drug’s label, that decision reflects both a floor and a ceiling for regulation and state law may not hold that decision inadequate.90 the court summarily rejected this assessment of federal objectives because it was contrary to all evidence of congress’s purposes.91 the court explored the history of federal regulation of pharmaceutical approvals and was influenced by congress’s failure to expressly preempt, stating, “if congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the fdca’s 70-year history.”92 the court found congressional silence, in the face of “awareness” of concurrent state tort litigation, to be “powerful evidence that congress did not intend fda oversight to be the exclusive means of ensuring 84. id. at 1195, n.3. 85. id. at 1197-98. 86. id. at 1198. 87. id. at 1198-99. 88. id. at 1199. 89. id. 90. id. 91. id. 92. id. at 1200. congress had not expressly preempted state tort law claims as it had in other contexts, such as in the mdas. id. 306 indiana health law review [vol. 8:2 drug safety and effectiveness.”93 the court explored the many ways that tort law acts as a complement to federal drug regulation,94 and found the fda’s “newfound opinion” to the contrary to be inconsistent with the “longstanding coexistence of state and federal law and the fda’s traditional recognition of state-law remedies”95 and, thus, unpersuasive on assessing a current conflict with federal objectives. wyeth v. levine represents a narrower implied obstacle conflict preemption analysis than geier. the court seems to have settled into a more balanced approach to the value of state common law tort actions within its implied conflict preemption analysis if not so clearly in its express preemption analysis. iv. synthesis of preemption analysis the court has at times stated that the presumption against preemption of historic state police powers continues to operate in cases of both express and implied preemption. the court has also evaluated express preemption provisions without reference to the presumption, as in riegel. in cipollone, lohr, bates, and altria group, the court required clear and manifest intent of congress to the contrary to defeat the presumption. the presumption was also important in wyeth v. levine. the question remaining is whether the presumption will, indeed, operate as a default in express preemption cases where the statutory language of preemption does not lend itself to a finding of clear congressional intent. bruesewitz provides an answer to that question though it is unclear what the extent of bruesewitz’s reach will be. when an express preemption provision provides “clear and manifest” evidence of congress’s intent, it will control.96 justice stevens, in cipollone, lohr, bates, altria group, and, to a lesser extent, in his concurrence in riegel, provides the best statement of the current manner of interpreting express preemption provisions to discern congressional intent: narrowly based on the ordinary meaning of the statute’s terms, its structure, purposes, and history, with an understanding that congress would not defeat the operation of traditional, historic police powers of the states without explicitly 93. id. further, “[congress] may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.” id. at 1199-1200 (alteration in original). the court rejected reliance on the fda’s “mere assertion” that state law poses an obstacle. id. at 1201. instead, it confirmed that “[t]he weight we accord the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness.” id. 94. id. at 1202. “state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. they also serve a distinct compensatory function that may motivate injured persons to come forward with information. failure-to-warn actions, in particular, lend force to the fdca’s premise that manufacturers, not the fda, bear primary responsibility for their drug labeling at all times.” id. 95. id. at 1203. 96. see davis, the “new” presumption, supra note 3, at 1247. 2011] the case against preemption: vaccines & uncertainty 307 saying so.97 all of this seems to suggest that a “new” presumption against preemption operates as a meaningful default rule when interpreting congressional intent to preempt.98 clarity is in the eyes of the beholder, as the different results in riegel and altria group suggest. even though the court did not mention the presumption in riegel, the discussion in altria group on the heels of riegel might portend that a majority has rejected a lesser role for the presumption in express preemption cases. “the court seems intent on assessing statutory language with particularity, to discern whether the terms used, such as “requirements,” “statements,” or “standards,” fairly include state common law claims under the relevant statute’s history alone, and not with reference to use of the terms in other statutory schemes.”99 this text-centered focus has arisen after years of attempting to force terms from one statute, such as “requirements,” to apply to the meaning of the same term in a different statute.100 the presumption against preemption as default may reduce the overreaching of statutory definitions by requiring a tighter fit between context and language.101 v. vaccine act preemption: bruesewitz v. wyeth llc if the court’s analysis of express preemption provisions teaches anything, it is that statutes are unique, and so is the search for congressional intent based on statutory text. relying on the interpretation of terms from one statute runs the risk of proving too much in the interpretation of similar language in another statute. in an earlier article, i proposed that recent vaccine act cases, including bruesewitz, would put this analysis to the test.102 the court has now answered the question by finding preemption in a hyper-textual analysis which does not refer to the presumption against preemption, or to other elements of preemption doctrine for that matter. there is no question that vaccination of children has been spectacularly successful in eradicating the disastrous consequences of many childhood illnesses. there is also no question that vaccinating a child introduces a toxin into the child’s system that may cause a devastating side effect. those side effects are inevitable in some portion of the vaccinated population. the vaccine act was intended to compensate, under a no-fault regime, children who were injured from a vaccination, and the only question 97. see davis, the “new” presumption, supra note 3, at 1247. 98. id. 99. id. at 1248. 100. id. at 1247. 101. id. 102. see generally id. 308 indiana health law review [vol. 8:2 is which state tort laws survived the creation of the compensation scheme and which ones did not.103 tort laws historically have been seen as a complement to federal drug regulation by courts and federal regulators.104 tort actions uncover unknown hazards and provide incentives for drug manufacturers to disclose safety risks promptly. they also serve a distinct compensatory function that may motivate injured persons to come forward with and uncover information about previously undisclosed or under-disclosed risks. the fdca’s “central premise” is that manufacturers bear primary responsibility for their drug labeling at all times.105 the same is true of vaccine manufacturers who are regulated under the public health service act,106 the fdca,107 and the vaccine act.108 vaccine licenses are granted if vaccine manufacturers meet standards designed “to insure the continued safety, purity, and potency” of vaccines.109 since 1972, the fda has regulated vaccines and other biologics under the new drug application process.110 to obtain approval, the manufacturer need not establish that the vaccine is the safest possible, nor that there are no feasible alternative formulations.111 rather, the fda is not involved in initiating or conceptualizing the structure of a vaccine. the fda is not a drug or vaccine design agency: it is an approval agency. it has limited authority to require post-marketing monitoring which is “not a top priority.”112 the fda relies on the vaccine adverse event reporting system (“vaers”), a passive reporting system that relies on voluntary reporting of adverse events that are inevitably underreported.113 nor does it have authority to require a manufacturer to adopt a safer alternative for a licensed 103. see generally national childhood vaccine injury act of 1986, 42 u.s.c. §§ 300aa-1 to 300aa-33 (2006). 104. wyeth v. levine, 129 s. ct 1187, 1202 (2009). 105. id. at 1197-98. 106. see generally public health service act of 1944, ch. 373, 58 stat. 682 (codified as amended, beginning at 42 u.s.c. § 201). 107. see generally 21 u.s.c. §352. 108. see generally 42 u.s.c. §§ 300aa-1 to 300aa-34. 109. see 21 c.f.r. § 600.3(n) (2011). 110. see 21 c.f.r. § 312.2(a), 312.20-312.38. like the proponent of a new drug, the sponsor of a vaccine must prove, among other things, that the vaccine is safe and effective. see 42 u.s.c. § 262 (2006). 111. see hurley v. lederle labs, inc. 863 f.2d 1173, 1177 (5th cir. 1988) (noting that the fda is a “passive agency”). see also thuy d. pham & annette martinez, the polio vaccine and the restatement (third) of torts: why the controversies, 11 depaul j. health care l. 125, 158-59 (2008). 112. see brief for petitioners at 11, bruesewitz v. wyeth llc, 131 s.ct. 1068 (2011) (no. 09-152) (quoting office of inspector gen., u.s. dep’t of health and human services., fda’s monitoring of postmarketing study commitments ii-iii (june 2006)), available at 2010 wl 2130598. 113. final order on categorization of anthrax vaccine absorbed, 70 fed. reg. 75,180, 75,190 (dec. 19, 2005). 2011] the case against preemption: vaccines & uncertainty 309 vaccine.114 the vaccine act creates a no-fault compensation system for victims of certain vaccine-related injuries while encouraging vaccine manufacturers to continue vaccine production at reasonable cost.115 none of the statutes which have been the subject of express preemption analysis have involved a congressionally mandated compensation scheme that supplements, or displaces, state tort actions. when congress created the vaccine act administrative compensation scheme, specifically designed to further the compensation of injured victims of vaccinations, did congress essentially take over the world of vaccine injury compensation? the supreme court says it did.116 the vaccine act preemption provision is found in a section titled “standards of responsibility.” that provision states: “except as provided in subsections (b), (c), and (e) . . . state law shall apply to a civil action brought for damages for a vaccine-related injury or death.”117 subsection (b)(1) states: no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after october 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.118 subsection (e), titled “preemption” prohibits states from foreclosing any other civil actions against manufacturers if they are not already barred by this part.119 hannah bruesewitz suffered seizures in 1992 almost immediately upon taking the third dose of a five-dose regimen of the dtp (diphtheria, tetanus and pertussis) vaccine tri-immunol, a whole cell pertussis vaccine.120 the whole-cell pertussis vaccine had been linked to a variety of adverse events which led to efforts to produce an acellular vaccine.121 the acellular vaccine was not available for hannah’s third dose in 1992, but it became available shortly thereafter.122 wyeth, the successor to lederle labs which 114. see 21. c.f.r. 601.5. 115. see id. see also bruesewitz v. wyeth, inc., 561 f.3d 233, 235-36 (3d cir. 2009) (discussing history and structure of act). 116. bruesewitz v. wyeth llc, 131 s. ct. 1068, 1082 (2011). 117. 42 u.s.c. § 300aa-22 (2006). 118. 42 u.s.c. § 300aa-22(b)(1). 119. 42 u.s.c. § 300aa-22(e). 120. bruesewitz v. wyeth, inc., 561 f.3d 233, 236 (3d cir. 2009). hannah’s particular vaccine came from a lot that generated sixty-five reports of adverse reactions. id. at 237. 121. id. at 236. 122. id. at 237. 310 indiana health law review [vol. 8:2 made hannah’s vaccine, voluntarily discontinued making the whole-cell pertussis vaccine in 1998.123 hannah’s parents sought compensation from the vaccine court in april 1995 for hannah’s injuries which, until one month before, had been table injuries, signifying that they were compensable in vaccine court upon a showing of injury and proximity of onset of injury to the administration of the vaccine.124 hannah’s parents’ claims were denied seven years later in 2002.125 hannah’s parents rejected the court’s judgment and filed suit in state court, however, the case was removed to federal court, which dismissed the claim as preempted.126 the third circuit court of appeals affirmed.127 in an earlier article, i opined that the court should find that the statute did not preempt all design defect litigation.128 the statute appears on its face to carve out some design defect claims that are not preempted by using the term “unavoidable.” the statute is complex and its structure and history seem to admit of different conclusions regarding preemptive intent. the case presents a unique federal compensation scheme, however, which clearly displaces the operation of a substantial amount of state common law by its very terms. the supreme court, in an opinion by justice scalia, finds preemption based entirely on an analysis of the text.129 after explaining the impetus for the act, and describing the no-fault compensation system, the majority 123. id. 124. id. 125. id. 126. see bruesewitz v. wyeth, inc., 508 f. supp. 2d 430 (e.d. pa. 2007). 127. bruesewitz, 561 f.3d at 255-56. the supreme court granted certiorari, arguably as a result of the split that had occurred between the federal courts of appeals and the state courts. the georgia supreme court previously upheld a finding of no preemption in a case involving alleged neurological damages caused by vaccines made with a mercury-laden preservative for which an alternative was available. see american home products corp. v. ferrari, 668 s.e.2d 236 (ga. 2008). the georgia supreme court affirmed a finding of no express preemption of the design defect claim, concluding that the statute required a case-bycase determination of unavoidability. id. at 238-43. interestingly, a pennsylvania superior court has recently decided that the vaccine act preemption provision does not preempt such design defect claims. see wright v. aventis pasteur, inc., 14 a.3d 850 (pa. super. ct. 2011). that case was, of course, before the supreme court’s decision in bruesewitz. 128. davis, the “new” presumption, supra note 3, at 1251 (“ferrari may have the better analysis because it recognizes that the compensation scheme congress created did not specifically articulate those claims that may be deemed unavoidable. . . . the presumption against preemption, requiring a narrow reading of the terms of a statute with a view to maintain state law absent clear evidence to the contrary, supports, in principle, the result in ferrari—not all design defects in vaccines are the result of unavoidable conditions. proof of congress’s intent will also, of course, be assessed by reference to the legislative history and the purposes behind the compensation scheme. if clear preemptive intent can be derived, it will control.”). i also predicted in my first article on preemption, unmasking the presumption in favor of preemption, 53 s.c. l. rev. 967 (2002), that the supreme court would find express preemption in sprietsma v. mercury marine, 537 u.s. 51 (2002). the court unanimously found no preemption. i have learned my lesson. 129. bruesewitz v. wyeth llc, 131 s. ct. 1068, 1075-79 (2011). 2011] the case against preemption: vaccines & uncertainty 311 opinion strikes through the express preemption provision with the editing pen of an expert grammarian.130 in the best sentence diagramming tradition, justice scalia finds that the “even though” clause clarifies the word “unavoidable” that precedes it: “it delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered ‘unavoidable’ under the statute.”131 the court concludes that, “a side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element. the language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action.”132 thus, justice scalia resolves the ambiguity about unavoidability by concluding that it is unavoidable “with respect to the particular design” and not with respect to competing alternative designs that might be available.133 in design defect claims, the plaintiff must establish the condition that makes the design defective, and that typically includes establishing an alternative design that would have reduced the risk without impairing the functioning of the product. consequently, it is also plausible that congress intended that only vaccine formulations for which there was no feasible substitute, and for which there were, therefore, unavoidable side effects, were protected from liability. this is the dissent’s argument, and one based on comment k to restatement (second) of torts section 402a, from which congress constructed the vaccine act preemption provision.134 that interpretation of section 22(b) also is a fair, but narrow interpretation which gives meaning to the presumption against preemption of state law, which justice scalia never mentions. justice scalia supports his interpretation of the act by noting that the statute mentions manufacturing defect claims and failure to warn claims but never mentions design defect claims.135 he concludes that this failure must be a “deliberate choice, not inadvertence.”136 “expressio unius, exclusio alterius.”137 justice scalia recognizes that the “if” clause makes sense un 130. id. at 1073-74. 131. id. at 1075. 132. id. 133. id. at 1076. see also id. at n. 35 (the court recognizes the problem when it responds to the dissent’s argument on the point in footnote 35 by stating, “[t]he dissent makes no effort to ground that position in the text of [the act]. we doubt that congress would introduce such an amorphous test by implication when it otherwise micromanages vaccine manufacturers.” (alteration in original)). 134. id. at 1089-1093 (sotomayor, j., dissenting). see generally, brief for petitioners at 29, bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011) (no. 09-152); brief of mark a. geistfeld, as amicus curiae in support of petitioners, bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011) (no. 09-152). 135. bruesewitz, 131 s. ct. at 1078-79. 136. id. at 1076. 137. id. 312 indiana health law review [vol. 8:2 der either the majority’s or the dissent’s assessment of it.138 he rejects reference to comment k as unnecessary: “‘unavoidable’ is hardly a rarely used word.”139 justice scalia and justice sotomayor in dissent argue over whether the “even though” clause is a concessive subordinate clause or whether it is a coordinating conjunction.140 justice scalia agrees that congress could have written the clause more clearly, rendering the words after “unavoidable” superfluous.141 he concludes that such superfluity is not a problem because the dissent’s position “has superfluity problems of its own.”142 the grammar debate is resolved in justice scalia’s favor by the six person majority. the majority opinion also looks to the structure of the vaccine act to reinforce his reading of the preemption provision.143 in this section of the opinion, he discusses the difficulty of “[s]triking the right balance between safety and efficacy” in the case of vaccines.144 he comments that the act, “which in every other respect micromanages manufacturers, is silent on how to evaluate competing designs.”145 he expresses concern over the lack of guidance in the act regarding how to assess alternative designs, and concludes that such lack of guidance “strongly suggests that design defects were not mentioned because they are not a basis for liability.”146 of course, the fda does not evaluate competing designs, in the vaccine context or in the drug context. consequently, such “lack of guidance” just as likely supports the conclusion that design defects are, indeed, intended to support a basis for liability. the regulatory structure at the time of the vaccine act defaulted to state tort law to make such assessments, as justice sotomayor points out.147 the key to justice scalia’s opinion, seems to be, his perception that the compensation program, in combination with the reporting, monitoring and collaborative work of federal regulators, was a conscious choice by 138. id. 139. id. at 1077. 140. id. at 1077-78; id. at 1087 (sotomayor, j., dissenting). 141. id. at 1078. 142. id. at 1078, n.48. 143. id. at 1078-80. 144. id. at 1079. 145. id. 146. id. (“jurors, of course, often decide similar questions with little guidance, and we do not suggest that the absence of guidance alone suggests preemption.”). 147. id. at 1097 (sotomayor, j., dissenting) (“although the vaccine act charges the secretary of health and human services with the obligation to ‘promote the development of childhood vaccines’ and ‘make or assure improvements in . . . vaccines, and research on vaccines,’ neither the act nor any other provision of federal law places a legal duty on vaccine manufacturers to improve the design of their vaccines to account for scientific and technological advances. indeed, the fda does not condition approval of a vaccine on it being the most optimally designed among reasonably available alternatives, nor does it (or any federal entity) ensure that licensed vaccines keep pace with technological and scientific advances.” (internal citation omitted)). 2011] the case against preemption: vaccines & uncertainty 313 congress “to set priorities for federal vaccine research, and to coordinate federal vaccine safety and efficacy testing.”148 the ostensible silence regarding design defect litigation “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the fda and the national vaccine program rather than juries.”149 the vaccine act’s structural quid quo pro, the fund for compensation, was at least in part in exchange for freedom from the costly tort litigation system.150 in response to justice sotomayor’s concern that the fda and the vaccine program are insufficient to spur adequate vaccine innovation and uncover information of risk, justice scalia considers this issue to be beside the point.151 not unsurprisingly, justice scalia finds no need to refer to the legislative history even though he recognizes that some of his colleagues would do so as a tool of statutory interpretation.152 what is to be made then, of the importance of bruesewitz to express preemption analysis? it is a classic textual interpretation. justice scalia is not a fan of the “fair but narrow” interpretation of such provisions, as evidenced by his debates with justice stevens in cases like cipollone and altria group. bruesewitz is very much like riegel in its approach to assessing congressional intent solely through the text of an express preemption provision.153 justice scalia is also not a fan of the presumption against preemption, which justice sotomayor refers to only in a footnote.154 the presumption against preemption, had it been considered, supports the status quo of design defect liability whose operation was both known to congress, understood by congress, and the industry, based on longstanding practices. the court continues to be erratic regarding the place of the presumption, signaling a return to its disfavor. congress created a compensation alternative for most vaccine injury claims but clearly not for all. that congress was able to accomplish enactment of such a scheme seems remarkable in light of the seemingly intractable legislative debates over most issues that come before congress that we are witness to today. one could say, with regard to the compensa 148. id. at 1080. 149. id. 150. id. 151. id. 152. id. justice breyer, concurring, would look to the legislative history for support of the interpretation of the express preemption provision which he says is “a close” question. id. at 1082-83 (breyer, j., concurring). 153. see 552 u.s. 312 (2008). 154. bruesewitz, 131 s. ct. at 1096, n.15 (2011) (sotomayor, j., dissenting) (“given the long history of state regulation of vaccines, the presumption provides an additional reason not to read § 22(b)(1) as pre-empting all design defect claims, especially given congress’ inclusion of an express saving clause in the same statutory section, and its use of the conditional ‘if’ clause in defining the pre-emptive scope of the provision.” (internal citations omitted)). 314 indiana health law review [vol. 8:2 tion scheme, that if congress had wanted to create a different kind of scheme, say a truly exclusive compensation scheme, it could have said so much more clearly than it did. that criticism proves too much because it will, in hindsight, always be true of any legislative enactment. tort litigation operating as a background to the vaccine act administrative scheme supports both the compensatory purpose of the act and the incentive to create safer vaccines, but not as neatly as in cases in which there is no congressionally created compromise compensation scheme. the majority concluded that congress need not create a compensation system that mirrors the tort litigation system to have intended to preempt that system.155 that is fair. it also strikes me that bruesewitz is unlikely to have broad impact on preemption of common law tort claims given the unique nature of the congressional compensation scheme in issue. vi. the role of uncertainty vaccines have side effects, many of which are known, but not all. information about the true nature of what such toxins do once introduced into the body, like what drugs do to the body, is produced over time—decades perhaps. information about the risks known when a vaccine or other drug is approved immediately becomes out of date as soon as that vaccine or drug is widely used in the general population. the larger the population exposed to a drug or vaccine, the greater the potential of unanticipated side effects and the greater the need to acquire and respond to that knowledge to enhance public safety. i have always advocated that the tort litigation system provides the incentive for drug manufacturers to acquire and act on that knowledge of which only they are fully aware. the fda, nor any regulatory agency, is simply incapable of acquiring and acting on that information as effectively as the manufacturer. many have commented on the fda’s inability to track post-marketing adverse events of pharmaceuticals it approves.156 the manufacturer is in command of that information. “science aims at the truth without ever being certain.”157 the truth is illusory. the vaccine program that congress created to respond to the known risks of childhood vaccines in 1986 was laudable. but time passes, and additional risks become realized. who has the incentive to make the population aware of those risks? the well-intentioned federal regulators 155. id. at 1079-82. 156. id. at 1099, n.20 (sotomayor, j., dissenting) (“[w]e observed in levine that the fda is perpetually understaffed and underfunded, and the agency has been criticized in the past for its slow response in failing to withdraw or warn about potentially dangerous products. these practical shortcomings reinforce the conclusion that ‘state law offers an additional, and important, layer of consumer protection that complements fda regulation.’” (internal citations omitted)). 157. dictionary of the history of ideas: certainty since the twentieth century, 323 (philip wiener ed., 1973). 2011] the case against preemption: vaccines & uncertainty 315 certainly do. but do they have the capacity? as with other drug regulation, the fda has limited post-marketing authority regarding vaccines. the centers for disease control gathers and tracks vaccine injury information and does comparative analyses of those already on the market, but it does not examine whether a safer alternative is available, and neither does any federal government agency.158 as with research on the safety and effectiveness of other drugs, research on vaccine safety remains flawed and incomplete. the vaccine program provides for additional vaccines to be added to the table and for injuries to be included. that has not worked as smoothly as some would have hoped.159 indeed, there is much criticism of the way vaccine court operates.160 the vaccine injury compensation program is a good model because it incorporates the opportunity to add vaccines and injuries to the vaccine table over time. unfortunately, more injuries have been removed from the table than have been added to it in the past decades,161 and vaccines have been added with no corresponding injury side effect identified. that in itself may be the result of inadequate information. there continues to be a need to maximize avenues for acquiring information about vaccine risks. the ever present possibility of the operation of the tort system as a watchdog fulfills that role, but the tort system does not fit cleanly into the process, and is often an inefficient solution. often, the system is used as a sledge hammer instead of the proverbial scalpel, but many safeguards of that system have been in place for decades; the burden of proof, the requirement of general and special causation, the expense of discovery and cost of litigation to all the parties to name a few. these are significant deterrents to widespread overuse of the civil action instead of the administrative scheme that congress put in place. it is such cases in which the presumption against preemption should operate to preserve longstanding traditional tort laws of responsibility. product manufacturers, including vaccine manufacturers, have regulatory and market incentives to improve their products performance, but the everpresent possibility of the tort system operating to uncover the risks of which only the manufacturer realistically will be aware is a powerful one. yes, 158. bruesewitz, 131 s. ct. at 1099, n.19 (sotomayor, j., dissenting). 159. see brief of amici curiae national vaccine information center, its co-founders and 24 other organizations in support of petitioners at 13-14, bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011) (no. 09-152); brief of amicus curiae marguerite willner in support of petitioners at 21-23, bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011) (no. 09-152). 160. see national vaccine injury compensation program, hrsa.gov, http://www.hrsa.gov/vaccinecompensation/statistics_report.htm#claims_filed (last visited may 19, 2011) (showing approximately twenty percent of petitions that have been compensated). 161. see, e.g., brief of vaccine injured petitioners bar association, the george washington university law school vaccine injury clinic, and zenoria phillips deloatch, as personal representative of the estate of moshella f. roberts, as amici curiae in support of petitioners passim, bruesewitz v. wyeth llc, 131 s. ct. 1068 (2011) (no. 09-152). 316 indiana health law review [vol. 8:2 the need for a healthy vaccine supply is great. the burden to establish congressional intent to immunize the entire industry for its design choices should also be great and the presumption against preemption represents that burden. the majority in bruesewitz did not see it that way. the court may be determined to simply resolve preemption matters on a statute by statute basis, which will have the effect of creating administrative agency preemption for some agencies and for some tort claims but not for others. that result would be unfortunate and unfair. it would increase the uncertainty that currently exists about the preemptive scope of regulatory schemes. it would attach a preemption analysis to statutory language that the authoring congresses could not have imagined. it may be, however, that the agency-by-agency approach the supreme court is implementing through its preemption doctrine will have the effect of spurring society to have the kind of society wide conversation that judge calabresi envisions.162 it may force our legislators, regulators, judges, lawyers and policy experts to engage in a meaningful way about the kind of regulatory system that may be needed to respond to excessive risks in our increasingly complex society, to compensate fairly for those risks, and to reduce them appropriately in the balanced way that the majority opinion in bruesewitz thought congress did in the case of vaccines. uncertainty is inevitable. systems must respond to inevitable uncertainty and inadequacy of information. having a mechanism by which the uncertainty inherent in one system is evaluated through the lens of another, even if only occasionally, enhances the opportunity to reduce the uncertainty. we should not so quickly dismiss the tort litigation system as an important, longstanding complement to more formal regulatory action for responding to uncertainty in risk information. in the light of the past twenty years, the vaccine program has been moderately successful. moderately, because there are many who complain the program is slow, unfriendly to victims, and more restrictive in operation than was originally intended.163 the operation of the program was not at issue in bruesewitz. one might hope that, now that design defect litigation is no longer available as a complement to the compensation system, the program will increasingly come under scrutiny to defend its effectiveness in carrying out its mandate to compensate and increase vaccine safety. 162. see calabresi, supra note 15. 163. see brief of amicus curiae marguerite willner, supra note 159, at 3. (“the compensation system has not lived up to congress’s expectations. hhs, which administers the program, has wrought administrative changes that make it difficult for petitioners to recover for their injuries. . . . these difficulties, coupled with the dearth of information about vaccine safety, render state tort actions a critical safety-valve in the regulatory system.”). laryngoscopes, lidocaine, and liability: the absence of immunity protection for prehospital providers in indiana meghana. cox· table of contents i. introduction ................................................................................. 78 it. trends in ems lmgation ............................................................ 81 a. chicago: 1976-1987 .................................................................. 81 b. miami-dade county: 1972-1982 .............................................. 81 c. denver: 1984-1993 ................................................................... 82 d. denver: 1993-1998 ................................................................... 82 ill. constitutional claims inyoking42 u.s.c. § 1983 ("§1983'') ...... 83 a. the fourth amendment .............................................................. 84 b. the eighth amendment .............................................................. 86 c. the fourteenth amendment ....................................................... 87 iv. civil liability statutes .................................................................. 89 a. statutory provisions for cmi liability in indiana and surrounding states ..................................................................... 89 1. indiana ................................................................................ 89 2. michigan .............................................................................. 91 3. illinois .................................................................................. 91 4. ohio ..................................................................................... 92 5. kentucky .............................................................................. 92 b. states providing for liability for ordinary negligence ............. 92 c. application of ordinary negligence standard to emi's ............ 93 v. the indiana medical malpractice act .................................... 94 a. generally .................................................................................... 94 b. the patient's compensation fund ............................................. 96 vi. the policy considerations driving immunity ........................ 97 a. the state of ems in indiana ...................................................... 97 b. other statutory grants of immunity ........................................... 98 1. indiana code section 16-31-6-4: immunity in disaster emergency ........................................................................... 98 2. indiana code section 34-30-12-1(b): good samaritan law ...................................................................................... 99 c. the role offirefighter/emi's .................................................. 101 d. the prevalence ofshiftwork .................................................... 102 * j.d. candidate, 2009, indiana university school oflaw -indianapolis; b.a., 2006, the college of william and mary; indiana emergency medical technicianbasic. 78 indiana heal til law review [vol. 6:77 e. administrative liability ............................................................ 103 vu. conclusion .................................................................................. 104 i.introduci'ion on february 16, 1968, then-alabama speaker of the house, rankin fite, placed the first-ever 911 call from city hall to the police station in haleyville, alabama.1 thirty years later, president clinton signed the wireless communi­ cations and·public safety act of 1999, which designated "911'' as the nation­ wide emergency number.2 since that first 911 call forty years ago, dramatic changes have occurred in the response provided to an emergency call, especial­ ly with regard to the provision of emergency medical services ("ems"). the public's expectations of emergency response have changed as well, but these changes may not necessarily reflect the reality of ems. public expectations have been shaped largely by media portmyals ofems response.3 recent generations have been exposed to television shows devoted to the dramatization of emergency response. from 1972 to 1979, for example, emergency! aired on nbc and portrayed a fictional crew oflos angeles coun­ ty fire department paramedics responding to emergencies.4 from 1989 to 1996, rescue 911 aired on cbs and featured dramatic reenactments of situa­ tions leading up to and following 911 calls.5 the show was devoted almost entirely to successful rescues. 6 other, more recent shows, such as e.r. and chicago hope, have continued to provide a glimpse into emergency medical care. the dramatic and selective nature of these shows has generated the per­ ception that virtually all prehospital interventions are successful. 7 of emergencies portrayed on television, the resuscitation of cardiac arrest patients exhibits the greatest discrepancy between how it is portmyed on televi­ sion and actual statistics. 8 a 1996 study of the television programs chicago hope, er, and rescue 911 found that the programs gave misleading portrayals 1. see the history of 911, dispatch monthly magazine, available at http://www.911dispatch.com/ 911/history (last visited jan. 9, 2008). 2. 47 u.s.c.a. § 615 (west 1999). 3. bryan bledsoe, have we set the bar too high?, 32 j. emergency med. servs. (march 2007), available at bttp://wwwjems.comlnews_and_articles/articles/jems/3203/have _ we_set_the_bar_too_high.html 4. see emergency! (1972), internet movie database, inc., http://imdb.com/titlel tt0068067 (last visited feb. 6, 2009). 5. see rescue 911 (1989), internet movie database, inc., http://imdb.com/title/ tt0096688/ (last visited feb. 6, 2009). 6. susan j. diem, et al., cardiopulmonary resuscitation on television, 334 new eno. j. med.1s78, 1581 (1996). 7. bledsoe, supra note 3. 8. ld. 2009] laryngoscopes, lidocaine, and liability 79 of cardiopulmonary resuscitation ("cpr")9 and death in three ways.10 first, the study found that the shows inaccurately represented the types of people most commonly given cpr: on television, sixty-five percent of those given cpr were children, teenagers, or young adults; in reality, cardiac arrest is much more common in the elderly. 11 second, the study found that the shows inaccurately reflected the causes of cardiac arrest: only twenty-eight percent of those on tel­ evision had a cardiac arrest attributable to underlying cardiac disease, as op­ posed to acute injury, such as gunshot wounds or motor vehicle collisions; in real life, underlying cardiac disease accounts for seventy-five to ninety-five per­ cent of all cardiac arrests.12 finally, the study found that cpr performed on the shows succeeded far more frequently than in real life: the three shows com­ bined showed a seventy-five percent survival rate immediately after cardiac arrest; 13 rescue 911, which admittedly focuses on the successes of emergency services, had a 100% post-cpr survival rate. 14 these shows,.and others like them, instill in the public an unrealistic impression of resuscitation efforts and their chances for success, showing overall survival rates significantly higher than the most optimistic statistics provided in medical literature. 15 public expectations have also been shaped by education campaigns de­ signed to promote the use of911 in emergencies. these public education pro­ grams have largely emphasized the importance of speed in obtaining an emergency response. 16 although response times less than four minutes from the time of patient collapse are highly correlated with improved resuscitation rates, 17 it would be prohibitively expensive for most ems agencies to consis­ tently provide response times under four minutes. 18 many ems systems have 9. american heart association, "cardiopulmonary resuscitation (cpr)," available at http://www.americanheart.orglpresenter.jhtml?identifier=4479 ("cpr is a combination of rescue breathing and chest compressions delivered to victims thought to be in cardiac arrest. when cardiac arrest occurs, the heart stops pumping blood. cpr can support a small amount of blood flow to the heart and brain to 'buy time' until normal heart function is restored."). 10. diem, et al., supra note 6, at 1580-81. 11. id. at 1581. 12. id. 13. ld. 14. !d. 15. jaqueline brooks, real cpr isn 't everything it seems to be, web md, may 14, 200 l, available at http://www.webmd.com/news/200 i 0514/real-cpr-isnt-everything-seems-to-be ("[o]nly between 5%-10% of people who undergo cpr will survive."). see generally diem, et al., supra note 6, at 1578. 16. bledsoe, supra note 3. 17. jd.; see also peter t. pons & vincent j. markovchick, eight minutes or less: does the ambulance response time guideline impact trauma patient outcome?, 23 j. emergency men. 43, 45-46 (2002). 18. pons & markovchick, supra note 17, at 47 ("it is not realistic to expect ever-shorter[ . . . ] ambulance response times to be the answer to meet all out-of-hospital medical needs and expectations. . . . [t]here is a significant financial cost associated with lowering ambulance response times. to do so means the addition of ambulance vehicles and paramedic staff at an approximate annual cost of $400,000 to $500,000 per 24 hi day staffed ambulance."). 80 indiana health law revmw [vol. 6:77 an eight-minute target response time;19 however, a 2002 study found that ''there is little evidence [ ... ] to suggest that changing [ ... ] response time specifica­ tions to times less than current, but greater than 5 minutes, would have any beneficial effect on survival. "20 ems personnel are already ''particularly vul­ nerable to malpractice allegations since they routinely treat patients in less than optimal locations with minimal if any history, no advance notice and with li­ mited resources."21 the added distortion of the importance of response times and the inflated survival rates portrayed to the public22 has primed the prehos­ pital patient care relationship for litigation. the purpose of this note is to map out the scheme of civil liability for ems providers in indiana and call into question the absence of minimal im­ munity protections for them. 23 part ll of this note explores the increasing trends in litigation against ems providers, as found in several studies con­ ducted between 1972 and 1998. part m explores the constitutional arguments that plaintiffs have made in attempting to hold emts liable for claimed defi­ ciencies in the provision of emergency medical services. part iv of this note introduces the civil liability provisions in the indiana code applicable to emts and the standard of care that those provisions impose. it considers these statu­ tory provisions, as compared to those of neighboring states. part v considers the potential impact of the indiana medical malpractice act (the "act") on ems providers. part vi considers the policy imperatives driving a grant of immunity for ems providers. this note concludes with the recommendation that, as a public policy matter, the indiana general assembly should provide immunity to emts for acts of ordinary negligence. 19. bledsoe, supra note 3. 20. thomas h. blackwell & lays. kaufinan, response time effectiveness: comparison of response time and survival in an urban emergency medical services system, 9 acad. emergency med. 288, 288 (2002). 21. bruce m. cohn & alan 1. azzara, lecialaspects of emergency med. serv. 8 (w.b. saunders company 1998). 22. see discussion of distorted portrayals of resuscitation on television, supra pages 2-3. 23. the state of indiana, through the indiana department of homeland security, offers three main levels ofems certification: emergency medical technician ("emt'')basic, emt­ intermediate, and emt -paramedic. see idhs: emergency medical services training program, indiana dept of homeland sec., available at http:l/www.in.gov/dhs/2476.htm. (the state of­ fers a fourth certification, emtbasic advanced, which provides an advanced life support (" alsj supplement to the emtbasic training, and thus will be grouped with emtbasic in this note). emtbasic is a basic life support ("bls'') certification; emt -intermediate and emtparamedic are als certifications. see 8361nd. admin. code 1-1-1(2) (2004). these certification levels correspond to the medical skills that a provider is trained and permitted to perform. generally speaking, als providers can perform skills including endotracheal intuba­ tion, initiating intravenous ("iv") lines, drug administration, electrocardiogram interpretation, and operation of a manual defibrillator. see id. indiana's ems training standards are "estab­ lished by the indiana emergency medical services commission and either meet or exceed the standards set by the national highway traffic safety administration (nhtsa) for ems pro­ grams;" idhs: emergency medical services training program, indiana dept. of homeland sec., available at http://www.in.gov/dhs/2476.btm. for purposes of this note, "emt" will refer to all levels of certification, and "paramedic" wid refer specifically to als personnel. 2009] laryngoscopes, lidocaine, and liabd...ity 81 ll. trends in ems lmgation the focus of this note is on liability for medical treatment rendered in the prehospital setting; therefore, the reader will note that it gives only limited con­ sideration to other possible sources oflitigation against ems providers, such as problems with dispatch or motor vehicle accidents involving responding ve-. hicles. even though the studies examining litigation against ems providers are generally not limited to claims for medical care, they are still illustrative of the general trends in this sort of litigationtrends which may influence, or be in­ fluenced by, the scheme of civil liability for ems personnel in a given jurisdic­ tion. a. chicago: 1976-1987 . . one study reviewed all claims brought against the chicago municipal am­ bulance service system from 1976 to 1987.24 lawsuits alleging "improper med­ ical treatment" accounted for seventy-seven percent of the claims.25 overall, there was one lawsuit per 27,371 responses, and one lawsuit per 17,995 patient transports. 26 almost one-third of the lawsuits involved patients who suffered cardiac arrest. 27 patient death, regardless of cause, increased the likelihood of a lawsuit.28 noting that the most common cause of litigation involved acts of omission, the authors recommended that ''prehospital providers should be en­ couraged to provide aggressive management when any doubt exists. ,,29 the study indicated an increasing number of claims filed against prehospital care providers over time, 30 trumpeting the importance of reconsidering the applica­ ble schemes of civil liability. b. murmi-dade county: 1972-1982 another study conducted during the formative stages ofems found simi­ lar resultsthat is, a low risk of litigation during the period of the study with an increasing instance of complaints over time. 31 this study looked at the claims filed against dade county fire rescue in miami-dade county, florida between 1972 and 1982, and found an incidence of one claim per 24,906 24. richardj. goldberg, et al,a reviewofprehospital care litigation ina large metropolitan ems system, 19 annals emergency men. 557,557 (1990). 25. id 26. id at 559. 27. id. 28. id 29. goldberg, supra note 24, at 561. 30. id. at 557. 31. joseph m. soler et al, the ten-year malpractice experience of a large urban ems system, 14annalsemergencymed. 982,982 (1985). 82 indiana health law review [vol. 6:77 runs. 32 more than half of the claims filed during the ten-year study period were filed in the last three years of the study. 33 the authors of the study offer some potential causes for this trend toward litigiousness, including ''the belief that in the public's eye the 'new glow' ofems has worn off; that yesterday's miracles are today's routine occurrences; that trauma system development points out the weaknesses and strengths ofprehospital care[ ... ] and that the public's senti­ ment is that all misfortunes are compensable events. ,,34 this same theme is rei­ terated elsewhere: "[o]ne of the most common fallacies among lay persons is the belief that malpractice is always responsible if medical treatment yields a bad, unsatisfactory or unexpected result. "35 · c. denver: 1984-1993 another study undertook a retrospective review of all claims made against the denver health paramedic division from 1984 to 1993.36 the study found an average of one claim per 5,084 runs.37 motor vehicle accidents involving ambulances accounted for seventy-two percent of the claims, while claims spe­ cifically alleging medical negligence represented less than four percent of the claims.38 notable, however, is that the medical negligence claims, while representing less than four percent of the claims, accounted for thirty-five per­ cent of the monetary losses paid out in legal claims. 39 d. denver: 1993-1998 a more recent study picked up where the previous research left off, look­ ing at all complaints in denver from 1993 to 1998, this time against the denver paramedic division. 40 the study, which was not limited to complaints brought for medical treatment, found a complaint rate of one per 1,075 ambulance res­ ponses, 41 a complaint rate substantially higher than that of the chicago and mi­ ami-dade county studies. of these, complaints alleging improper medical treatment represented twenty percent of the complaints,42 but the number may be higheraccording to the authors of the study, some medical treatment issues also may have been categorized as "rude behavior,'' a category which 32. id at 983. 33. id at 984. 34. id at 985. 35. cohn&azzara, supranote21,at8. 36. christopher b. colwell, et al, claims against a paramedic ambulance service: a ten-year experience, 17 j. emergency mel>. 999,999 (1999). 37. id. at 1000. 38. id. 39. id at 999. 40. christopher b. colwell, et al, complaints against an ems system, 25 j. emergency med. 403, 404 (2003). 41. id. 42. ld. at 406. 2009] laryngoscopes, lidocaine, and liability 83 represented another twenty-three percent of the claims. 43 the authors of the study concluded that "[t]he identification of areas of high dissatisfaction will hopefully lead to targeting of quality and performance improvement programs directed at customer service and risk management. ,,44 conspicuously absent from this recommendation are programs addressing the technical proficiency of prehospital providers, which may simply be an acknowledgement that the con­ ditions of prehospital emergency response are, by definition, less-than-ideal, and that it is inevitable that the conditions encountered in emergency response may sometimes surmount the resources available to prehospital providers in their efforts to provide medical care. it would be a mistake to derive any specific conclusions from this or the other studies as none of them were conducted in indiana, and are thus suscepti­ ble to the statutory provisions of their respective jurisdictions. it is, however, possible to discern a general trend toward increasing litigation involving ems agencies and providers. this trend warrants a reexamination of the provisions governing potential liability for prehospital providers in indiana. ill. constitutional claims invoking 42 u.s.c. § 1983 ("§ 1983") plaintiffs often attempt to bypass potential state immunity for government­ employed emts by filing claims alleging the deprivation of a federal constitu­ tional right. 45 these claims are brought under the authority of the civil rights act of 1871, which declares that [ e ]very person who, under color of any statute, ordin­ ance, regulation, custom, or usage, of any state or terri­ tory or the district of columbia, subjects, or causes to be subjected, any citizen of the united states or other per­ son within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the con­ stitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceed­ ing for redress.46 the seventh circuit court of appeals once described § 1983 as "the ubiquitous tort remedy for deprivations of rights secured by federal law (primarily the fourteenth amendment) by persons acting under color of state law. "47 without alleging more than inept medical care, plaintiffs have generally failed to state 43. /d. 44. /d. at 408. 45. philip stittleburg, force in solicited aid not always a violation, fire chief, oct. 2007, at 16. 46. 42 u.s.c.a. § 1983 (west 1996). 47. jackson v. city of joliet, 715 f.2d 1200, 1201 (7th cir. 1983). 84 indiana health law revlew [vol. 6:77 viable constitutional claims because "even if the complaints state good claims under general tort principles, it does not follow that they state good claims un­ der [§]1983 just because the defendants are public officers.'..t8 the decisions rejecting alleged constitutional violations for negligent emergency medical care are numerous and worth considering, especially in light of their policy implica­ tions. a. the fourth amendment the fourth amendment provides, in relevant part, that"[ t]he right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated. '.49 generally, moving a patient into an ambulance is not considered "custody" for purposes of the fourth amendment. 5° something more closely resembling a fourth amend­ ment violation may arise when emts must restrain a patient in order to effec­ tively administer medical aid, potentially running afoul of the prohibition on "unreasonable searches and seizures. "51 in peete v. nashville, 52 for example, emts restrained a man having an ep­ ileptic seizure, who then died shortly after being restrained. 53 the court grap­ pled with what is considered a "seizure" for purposes of the fourth amendment, distilling from precedent that it is "an intentional interference with a person's liberty by physical force or a show of authority that would cause a reasonable person consciously to submit. "54 since the decedent was uncons­ cious, the court found that no fourth amendment violation existed because the patient necessarily "could not perceive any restraint on his liberty or otherwise feel compelled to submitto a governmental show offorce."55 in another case, davidson v. city of jacksonville, 56 ems and fire person­ nel restrained an uncooperative patient suffering a hypoglycemic episode (low blood sugar), in order to check his vital signs, establish an iv line, and adminis­ ter medicine used to treat low blood sugar.57 after securing his hands with handcuffs, tying his ankles together, and connecting the two restraints with a bandage, they carried him by his arms and legs to the stretcher located at the 48. !d. at 1203. 49. u.s. const. amend. iv. 50. "the overarching prerequisite for custody is an affirmative act by the state that re­ strains the ability of an individual to act on his own behalf." jackson v. schultz,429 f.3d 586, 590 (6th cir. 2005). "the court has never held that one merely placed in an ambulance is in custody." !d. 51. u.s. const. amend. iv. 52. 486 f.3d 217 (6th cir. 2007). 53. !d. at 220. 54. !d. 55. !d. at 221. 56. 359 f. supp. 2d 1291 (m.d. fla. 2005). 57. id. 2009] laryngoscopes, lldocajne, and liability 85 front door. 58 the patient's mid-section was unsupported while being carried; he was subsequently diagnosed with a herniated disc and suffered a permanent disability as a result. 59 the court rejected the plaintiff's fourth amendment claim on grounds similar to those in peete, stating: ''there is no evidence that mr. davidson was aware of, or was mentally present in, the situation. instead, it seems that any 'resistance' was merely a result of the diabetic episode ... which mr. davidson was experiencing.'.60 the court held that the fourth amendment was inapplicable "given the lack of refusal on mr. davidson's part.'o6l indeed, the only viable fourth amendment claims against emts, when the emts are acting without law enforcement intervention or intent, are those in which a patient was capable of refusing treatment or transport, did refuse, but was transported or treated nonetheless. in green v. city of new york, 62 the pa­ tient-plaintiff suffered from lou gehrig's disease, required a mechanical venti­ lator to breathe, and if the mechanical ventilator malfunctioned, family members had to perform manual ventilation.63 one afternoon, after the patient­ plaintiff's mechanical ventilator failed, his family called 911 and initiated ma­ nual ventilation.64 by the time emts arrived, the patient-plaintiff was alert and oriented, and was able to non-verbally communicate-by blinking his eyes and using a computerthat he did not want to be transported to the hospital. 65 the emergency medical personnel on scene transported the patient-plaintiff any­ way. 66 the court held that seizing and transporting a competent adult for treat­ ment is a violation of the fourth amendment, unless he presents a danger to himself or others. 67 as gleaned from these cases, a fourth amendment claim against emts based solely on flawed medical care is not viable, because the emts are "not acting to enforce the law, deter or incarcerate . .,c;8 as in green, a patient with 58. /d. 59. id. at 1294. 60. id at 1295. 61. i d. this holding begs the question of what is sufficient to constitute a "refusal." ex­ press consent is required ftom every conscious, mentally-competent patient oflegal age before rendering treatment. see nat'l highway l'ransp. safely admin., u.s. dep't of transp., emergencymed. 'i'echnjcian-basl:c:nat'lstandardcurriculum68(1994),availab/eat http://www.nhtsa.dotgov/peoplelinjury/emslpublemtbnsc.pdf (hereinafter emt-basic: national standard curriculum] ; see also jon belding, patient refusal: what to do when medical treatment and transport are rejected, 31 no. 5 j. emergency med. services. 116, 116-17(2006); ind. code§§ 16-36-1-3-16-36-1-4 (1993). implied consent is given when an unconscious patient requires emergency medical care. and such consent is based on the assump­ tion that the unconscious patient would consent to emergency care if he was conscious. see emtbasic: national standard curriculum, supra at 68; see also belding, supra at 5. 62. 465 f.3d 65 (2d cir. 2006). 63. id. at 69. 64. ld. at 70. 65. id at 71. 66. id. at 73. 67. id at83. 68. peete, 486 f.3d at 222. 86 indiana health law review [vol. 6:77 the capacity to refuse consent may have a successful claim against emts who disregard such a refusal; however, those claims can be distinguished as dealing with the forcible seizure of a person by a government official, rather than deal­ ing with medical care. b. the eighth amendment plaintiffs may also allege violations of the eighth amendment for care rendered in the field. the eighth amendment prohibits, among other things, the inflicting of cruel and unusual punishment. 69 liability under the eighth amendment must necessarily be preceded by a determination that the patient is in custody under the fourth amendment. this is because the "[g]overnment generally has no constitutional duty to provide rescue services to its citizens, and if it does provide such services, it has no constitutional duty to provide competent services to people not in its custody."70 the implication is that the government must provide rescue services to people in its custody. the subse­ quent inquiry is what standard of care must be provided. in salazar v. chicago, 71 the decedent-plaintiff drove after drinking exces­ sively, and then ran into a parking meter and the front of a restaurant. 72 para­ medics were the first on-scene; they took the decedent-plaintiff's vital signs and began palpating his body for injuries, at which time he refused further examina­ tion. 73 the police arrived shortly thereafter and both the police and paramedics attributed the decedent-plaintiff's disorientated behavior to his intoxication. 74 the paramedics left, leaving the decedent-plaintiff with the police who subse­ quently arrested him. 75 he was taken to the police station that night and died the next afternoon from a traumatic liver laceration, a condition which had no obvious external symptoms. 76 at trial, when establishing the standard applica­ ble to their actions, the paramedics conceded that the decedent-plaintiff should have been treated as a pre-trial detainee. 77 the court then held that the eighth amendment imposes liability on the paramedics only if their behavior ''reflects complete indifference to riskwhen the actor does not care whether the other person lives or dies, despite knowing that there is a significant risk of death."78 as applied to the behavior of the pa­ ramedics in salazar, "[p ]erhaps [they] should have done more for salazar, and perhaps their failure to do more was either negligent or ( doubtedly) grossly neg69. u.s. const. amend. vill. 70. salazar v. city of chicago, 940 f.2d 235,237 (7th cir. 1991). 71. /d. 72. id at 234. 73. id. at 235. 74. id at 236. 75. /d .. 76. salazar, 940 f.2d at 236. 77. /d. at 237. 78. /d. at 238 (q~oting archie v. city ofracine, 847 f.2d 1211, 1219 (7th cir. 1988)). 2009] larynooscopes, lidocaine, and liability 87 ligent. but [their] actions do not evidence the complete indifference to sala­ zar's well-being that constitutes deliberate indifference."79 the seventh circuit defined "deliberate indifference" as conduct that is intentional or criminally reckless. 80 this definition is based on a consideration of what constitutes ''pu­ nishment," as the eighth amendment's prohibitions speak only to cruel and unusual punishment, and "[ a]ny state of mind short of criminal recklessness does not import danger so great that knowledge of the danger and thus, intent to inflict it, can be inferred.'.s1 in peete, the decedent-plaintiff, who had an epileptic episode and died af­ ter being physically restrained, argued that the behavior of the emts mani­ fested a deliberate indifference82 to serious medical needs, in violation of the eighth amendment.83 after the patient's fourth amendment argument failed, 84 the court rejected any argument rooted in eighth amendment protec­ tions: where the purpose is to render solicited aid in an emer­ gency rather than to enforce the law, punish, deter, or in­ carcerate, there is no federal case authority creating a constitutional liability for the negligence, deliberate in­ difference, and incompetence alleged in the instant case. the eighth amendment "cruel and unusual punish­ ment" clause raising a "deliberate indifference" stan­ dard does not apply here because becerra was not incarcerated and the purpose of the alleged wrong was not punishment. ss this case demonstrates that an eighth amendment violation occurs only if a patient is in custody at the time of receiving medical care, and the care rendered by the emt shows such complete indifference to the patient's well-being that it constitutes deliberate indifference. as this standard of care requires criminal recklessness, mere negligence by an emt, even gross negligence, is insuffi­ cient to impose liability under the eighth amendment. c. the fourteenth amendment a cursory glance at federal case law renders the impression that the most 79. salazar, 940 f.2d at 242. 80. id at 238; see also archie, 847 f.2d at 1218. 81. salazar, 940 f.2d at 239 (internal quotation nuuks omitted). 82. estellev. gamble, 429 u.s. 97, 104(1976) ("[d)eh"berateindifferenceto serious med­ ical needs of prisoners constitutes the uunecessmy and wanton infliction of pain [ •.. ] proscribed by the eighth amendment")(intemal citations omitted). 83. peete, 486 f.3d at 221. 84. see part ill.a, infra. 85. peete, 486 f.3d at 221. 88 indianaheallh law review [vol. 6:77 commonly alleged §1983 violations involving emts are violations of four­ teenth amendment protections, specifically the due process clause. 86 the due process clause provides that the government shall not "deprive any person of life, liberty, or property without due process of law.'.s7 just as the eighth amendment speaks to the standard of care owed to a patient in state custody, the due process clause imposes the standard of care on emts providing emer­ gency medical services to the general public. according to the supreme court, the due process clause "forbids the state itself to deprive individuals of life, liberty, or property without • due process oflaw,' but its language cannot fairly be extended to impose an affirmative obligation on the state to ensure that those interests are not banned through other means.'.s8 as a charter of negative liberties, the constitution seeks "to protect americans from oppression by state government, not to secure them basic governmental services.'o89 expanding the due process clause to include a right to government services •<would turn the clause on its head. it would change it from a protection against coercion by state government to a command that the state use its taxing power to coerce some of its citizens to provide services to others. "90 the general rule is that "there is no federal constitutional right to rescue services, competent or otherwise. moreover, because the due process clause does not require the state to provide rescue services, it [does not] ... place an affirmative obligation on the state to provide competent rescue services if it chooses to provide them."91 even when a municipality establishes itself as the primary provider of some service, it does not acquire a continuing constitutional duty to provide the service, since "such a position 'would open the way for scrutiny by the federal courts of virtually every municipal decision to reallocate protective resources."92 accordingly, the standard imposed by the fourteenth amendment on go­ vernmental actors is particularly low: state action must not be "arbitrary, or conscience shocking, in a constitutional sense.''93 this so-called "conscience shocking" test detennines liability for abusive executive action. 94 in evaluating constitutional claims, ••r w ]hether something less than intentional conduct 'shocks the conscience' varies depending on the context of the alleged viola86. u.s. const. amend. xiv, § 1. 87. id. 88. deshaneyv. winnebagocountydep't ofsocia1servs.,489u.s.189, 195 (1989). 89. jackson v. city of joliet, 715 f.2d 1200, 1203 (7th cir. 1983). 90. id. at 1203--04. 91. brown v. pennsylvania, 318 f .3d 473, 4 78 (3d cir. 2003) (citing, inter alia, salazar, 940f.2dat237);seealsoculver-union twp.ambulanceserv. v. steindler,629n.e.2d 1231, 1234 (ind. 1994) ("there is no constitutional right to be rescued by the government, and inept rescue is not a cognizable theory for due process liability under § 1983. "). 92. wideman v. sballowford cmty. hosp., 826 f.2d 1030, 1036 (lith cir. 1987) (citing jackson v. byrne, 738 f.2d 1443, 1447 (7th cir. 1984)). 93. christensen v. county of boone, 483 f .3d 454, 462 (7th cir. 2007). 94. id at 462. 2009] laryngoscopes, lidocaine, and llablllty 89 tion. "95 this standard is sufficiently low that constitutional liability for negli­ gent medical treatment rendered by emts does not come within its scope. 96 although some federal holdings could be read to narrow or refine the ap­ plication of this standard, negligent prehospital care still fiills outside ofliability even under the narrowed applications. in brown, the third circuit held that ''the 'shocks the conscience' standard should apply in all substantive due process cases if the state actor had to act with urgency.'m the court applied the standard to an allegation of incompetence against emergency medical person­ nel.98 in ziccardi v. philadelphia,99 the court applied a substantive due process analysis to the conduct of two paramedics accused of moving a man who fell and subsequently became paralyzed.100 the court held that a due process viola­ tion required "proof that the [paramedics] consciously disregarded, not just a substantial risk, but a great risk that serious harm would result if, knowing [the patient] was seriously injured, they moved [him] without support for his back and neck. "101 iv. cmlliabiutysta1utes as the preceding section demonstrates, negligent medical care by emts is an insufficient ground upon which to base a constitutional claim under § 1983. thus, other provisions governing the standard of care must drive liability for indiana's prehospital providers based on negligent medical care. this section introduces those provisions. a. statutory provisions for civil liability in indiana and surrounding states 1. indiana in indiana, the standard for civil liability for ems providers is expressly provided for by statute. with regard to bls providers,"[ a] certified emergency medical technician [ ... ] who provides emergency medical services to an emer­ gency patient is not liable for an act or omission in providing those services 95. ld. 96. the u.s. supreme court has noted that "(i]t should not be surprising that the constitu­ tional concept of conscience shocking duplicates no traditional category of common-law fault, but rather points clearly away from liability, or clearly toward it, only at the ends of the tort law's spectrum of culpability. thus, we have made it clear that the due process guarantee does not entail a body of constitutional law imposing liability whenever someone cloaked with state authority causes harm." county of sacramento v. lewis, 523 u.s. 833, 848 (1998). 97. brown, 318 f.3d at 480 98. ld. 99. 288 f.3d 57 (3d cir. 2002). 100. id. at 57. 101. ld. at 66. 90 indiana healm law review [vol. 6:77 unless the act or omission constitutes negligence or willful misconduct."102 for als providers, [ a]n act or omission of a paramedic or an emergency medical technician-intermediate done or omitted in good faith while providing advanced life support to a patient or trauma victim does not impose liability upon the pa­ ramedic or emergency medical technician-intermediate [ ... ] if the advanced life support is provided: (1) in con­ nection with an emergency; (2) in good faith; and (3) under the written or oral direction of a licensed physi­ cian; unless the act or omission was a result of negli­ gence or willful misconduct.103 though the language of the statutes differs, both provide for liability for acts constituting ordinary negligence. the language of the statute itself, how­ ever, is somewhat anomalous. a fundamental principle of common law is the imposition of a duty of reasonable care, with resulting liability for negligent acts.104 a statute imposing liability in the exact situation where the default common law already imposes it (e.g. a statute imposing liability for negligence) seems unnecessarily duplicative. additionally, expressly imposing liability for "negligence" and ''willful misconduct" in the same statute creates confusion because the two represent opposing behavioral extremes as it relates to a breach of the duty of care. a more logical progression would be to include negligence, gross negligence, and willful or wanton misconduct.105 generally speaking, liability for ordinary negligence is rare for ems pro­ viders because most states have statutes insulating emts from this type oflia­ bility.106 other states without specific statutes granting some sort of immunity to emts apply the protection of sovereign immunity to emts who are gov­ ernment employees or apply the provisions of the jurisdiction's "good samari­ tan" statutes to professional rescuers.107 as the following statutes demonstrate, all of the states surrounding indiana provide immunity from liability for, at the very least, acts of ordinary negligence by emts. 102. ind. code§ 16-31-6-l(a) (2008). 103. ind. code § 16-31-6-3 (2008). 104. restatement (third) of torts § 7 (2005) ("an actor ordinarily has a duty to exer­ cise reasonable care when the actor's conduct creates a risk of physical harm."). 105. the emt civil liability statutes ofmichigan. lllinois, ohio, and kentucky, provided infra, show a more natural progression ofbehavioral prohibitions, beginning with gross negli­ gence and proceeding to willful or wanton misconduct. 106. see generally frank j. wozniak. annotation, liability for negligence of ambulance anendants, emergency medical technicians, and the like, rendering emergency medical care outside hospital, 16 a.l.r. 5th 605 (1993). 107. /d. at 605. 2009] laryngoscopes, lidocaine, and liability 2. michigan 3. illinois unless an act or omission is the result of gross negli­ gence or willful misconduct, the acts or omissions of[ an ... ]emergency medical technician [or] paramedic,[ ... ] do not impose liability in the treatment of a patient on those individuals. 108 any person, agency or governmental body certified, li­ censed or authorized pursuant to [the ems] act or rules thereunder, who in good faith provides emergency or non-emergency medical services during a department approved training course, in the normal course of con­ ducting their duties, or in an emergency, shall not be ci­ villy liable as a result of their acts or omissions in providing such services unless such acts or omissions [ ... ] constitute willful and wanton misconduct. 109 91 illinois courts have done a particularly notable job of making clear the policies driving statutory grants of immunity: [b]y enactment of the immunity provision, the legisla­ ture intended to encourage emergency response by trained medical personnel without risk of malpractice liability for every bad outcome or unfortunate occur­ rence. emergency situations are often fraught with ten­ sion, confusion, and as here, difficult physical locations for giving medical care. emergency personnel must not be afraid to do whatever they can under less than ideal circumstances. 110 the court further notes: [t]he threat of impending liability[ ... ] is detrimental to the ability of medical personnel to effectively perform their duties. medical personnel work under extreme cir­ cumstances and must be able to make life-saving deci­ sions .... [liability] would not only impede the emts' 108. mich. comp. laws ann.§ 333.20965 (west 2007). 109. 210 ill. comp. stat. ann. 50/3.150 (west 2007). 110. gleason v. vill. of peoria heights, 565 n.e.2d 682, 684 (ill. app. ct. 1990). 92 4. ohio indiana heal til law rev1ew ability to render effective medical care, but it would also deter many from entering this profession and working under such circumstances. 111 a first responder, emergency medical technician-basic, emergency medical technician-intermediate, or emer­ gency medical technician-paramedic is not liable in damages in a civil action for injury, death, or loss to per­ son or property resulting from the individual's adminis­ tration of emergency medical services, unless the services are administered in a manner that constitutes willful or wanton misconduct.112 5. kentucky no [ ... ] person certified as an emergency medical tech­ nician by the kentucky cabinet for health and family services [ ... ] shall be liable in civil damages for admi­ nistering emergency care or treatment at the scene of an emergency outside of a hospital, doctor's office, or other · place having proper medical equipment excluding house calls, for acts performed at the scene of such emergency, unless such acts constitute willful or wanton miscon­ duct.tt3 b. states providing for liability for ordinary negligence [vol. 6:77 though some other states also allow for civil liability for acts of ordinary negligence by emts, none have done so as explicitly as indiana has in § 16-316-1. the routes taken by other states to impose an ordinary negligence standard vary, but generally involve invoking exemptions from other types of immunity protections. tennessee courts, for example, have concluded that emts are "health care practitioners" and are thus ineligible for the immunity protections provided by the state's governmental tort liability act.114 kansas courts took a different route but arrived at the same conclusion111. brock v. anderson rd. ass'n, 703 n.e.2d 568, 571 (til. app. ct. 1998). 112. omo rev. code ann. § 4765.49 (west 2007). 113. ky. rev. stat. ann.§ 411.148 {west 2005). 114. mooney v. sneed, 30 s. w.3d 304, 308 (tenn. 2000). in this regard, the language of indiana's governmental immunity statute, the indiana tort claims act ("itca "), is similar to that oftennessee. the itca expressly withholds immunity protections for ''medical care" ren­ dered by government officials by categorizing it as a ''ministerial act" ineligible for immunity. ind. code § 34-13-3-3(7) (2006). 2009] larynooscopes, lidocaine, and liability 93 liability for ordinary negligence. in james v. rowe, 115 the court concluded that both statutory construction and legislative history supported an interpretation of the kansas good samaritan act that applied its immunity protections only to those who "happen across an emergency outside the normal_course of their work and otherwise have no duty to assist,"116 thus rendering the statute inap­ plicable to emts responding to calls while on-duty. c. application of ordinary negligence standard to em/'s since indiana law provides for civil liability for emts who act negligent­ ly, a brief consideration of the elements of negligence and their application to the actions or omissions of ems providers is warranted. an action for negli­ gence must establish three elements: (1) a duty on the part of the defendant to conform his conduct to a standard of care arising :from his relation­ ship with the plaintlfl: (2) a failure of the defendant to conform his conduct to the requisite standard of care re­ quired by the relationship, and (3) an injury to the plain­ tiff proximately caused by the breach.117 the first element, a duty to act, is usually undisputed in a negligence action against an ems provider because "[i]fthe [emt] responds to a call with a des­ ignated agency, the duty already exists [ ... ] [i]f[the emt's] agency is the ems service responsible in a particular location and [the emt] is on duty, there is an obligation to provide service to anyone who requests assistance."118 119 the second element, a breach of the duty to act or deviation :from the standard of care, "asks what a reasonably prudent person would do in the same situa­ tion. "120 an emt "must exercise that degree of care, skill, and proficiency ex­ ercised by reasonably careful, skillful, and prudent practitioners in the same class acting under the same or similar circumstances. "121 in attempting to de­ fine the standard of care applicable to emts, the fact-finder may consider "[g]enerally accepted and recognized textbooks," "[t]he expected level of care provided by like providers in the community," "[s]tate and local protocols and national department oftransportation curricula;" and "[t]he agency's own op115. 674 f.supp. 332 (d. kan. 1987) (applying kansas law). 116. id at 333. see part v.b.2, irifra, for a consideration of indiana's good samaritan law. · 117. webbv. jarvis, 575 n.e.2d 992,995 (ind. 199l)(citationsomitted). 118. cohn & .azz.ar.a, supra note 21, at 9. 119. see part v.b.l, infra, for a discussion of the immunity available to off-duty emts under the good samaritan act. 120. cohn & .azz.ar.a, supra note 21, at 12. 121. dughaish ex rei. dugbaish v. cobb, 729 n.e.2d 159, 164 (ind. ct. app. 2000). 94 indiana health law review [vol. 6:77 erating procedures, policies and rules."122 in medical malpractice, the applica­ ble standard of care is often fiercely contended as it bears heavily on whether liability will stand and experts are generally used by both parties to identify the standard of care applicable to the circumstances at issue.123 the final element, proximate cause, can also be quite complicated in med­ ical malpractice actions, especially those alleging malpractice in the prehospital setting. in indiana, the plaintiff must prove: 1) that "the injury would not have occurred without the defendant's negligent act or omission;"124 and, 2) ''the injury was a natural and probable consequence of the negligent act, which, in the light of the attending circumstances, could have been reasonably foreseen or anticipated."125 the emt's conduct "must have set in motion a chain of cir­ cumstances which in natural and continuous sequence lead to the resulting in­ jury. "126 many patients cared for by emts are severely injured or suffering from a significant illness before an emt even arrivesit is "emergency" med­ ical services after all. even if there is clear negligence on the part of the emt, it may not be the proximate cause of the plaintiff's injuries and may not be a basis for recovery. v. the indiana medical malpractice act a. generally the indiana medical malpractice act (the "act") was enacted on april 17, 1975.127 the legislation was passed to help ease the strain placed on health care professionals seeking professional insurance, a strain that had a detrimental affect on the availability of health care services in indiana. 128 the act applies to emts if they qualify since the act defines "healthcare provider'' to include a ''paramedic, emergency medical technician-intermediate, emergency medical technician-basic advanced, or emergency medical technician."129 to qualify under the act, "the health care provider or the health care provider's insurance 122. cohn&azzara,supranote21, at 12. 123. n. genellleb, legal concepts and issues in emergencycarb214 (w.b. saund­ ers company2001). 124. perez v. bakel, 862 n.e.2d 289, 293 (ind. ct. app. 2007). 125. dughaish, 129 n.e.2d at 164; see also perez, 862 n.e.2d at 293 ("the second com­ ponent of proximate cause is the scope ofliability, which turns largely on whether the injury is a natural and probable consequence that in the light of the circumstances should have been fore­ seen or anticipated. under this doctrine, liability may not be imposed on an original negligent actor who sets into motion a chain of events if the ultimate injury was not reasonably foreseea­ ble as the natural and probable consequence of the act or omission." (internal quotation marks and citations omitted)). 126. dughaish, 729n.e.2dat 164. 127. 23 ind. prac. § 11.1 (citing ind. code .ann.§ 16-9.5-1-1 (west 1975)). 128. !d. (citing johnson v. st. vincent hosp., inc., 404 n.e.2d 585, 590 (ind. 1980)). 129. ind. code§ 34-18-2-14(2003). 2009] laryngoscopes, lidocaine, and liabjlity 95 carrier shall: (1) cause to be filed with the commissioner proof of financial re­ sponsibility established under ic 34-18-4; and (2) pay the surcharge assessed on all health care providers under ic 34-18-5.''130 an additional provision of the act of particular importance when considering ems providers is that "[a] claim against a governmental entity or an employee of a governmental entity based on an occurrence of malpractice is governed exclusively by this article if the governmental entity or employee is qualified under this article."131 132 under the reforms contained in the act, any potential medical malpractice claim against a health care provider who qualifies under the act must be pre­ sented to a medical review panel if the plaintiff claims damages in excess of $15,000.133 the medical panel consists of one attorney and three health care providers,134 two of whom must be members of the defendant's profession.135 the medical panel considers evidence submitted by both parties, including "medical charts, x -rays, lab tests, excerpts of treatises, [and] depositions of wit­ nesses including parties."136 then, the panel expresses an expert opinion "as to whether or not the evidence supports the conclusion that the defendant or de­ fendants acted or failed to act within the appropriate standards of care as charged in the complaint. "137 an opinion unfavorable to the plaintiff does not preclude filing a medical malpractice claim in court, but the opinion is admissi­ ble as evidence in subsequent litigation and members of the medical review panel may be called as witnesses by either party. 138 a plaintiff may file his claim in court while the proposed complaint is being considered by the medical review panel, but the complaint must not contain information that would allow a third party to identify the defendant provider, and the claimant may not pur­ sue the action beyond setting a date for trial until the medical panel has con­ cluded its review.139 in light of the provisions discussed above, the protection elements of the act are clear: the medical review panel and the expert opinion it expresses serve as a potential front-end limitation on frivolous lawsuits, and the act caps damage awards as a back-end limitation on the impact of exorbitant damage 130. § 34-18-3-2 (1998). 131. § 34-18-3-4( c) ( 1998); see alro jeffiies v. clark mem'l hosp., 832 n.e.2d 571, 573 (ind. ct. app. 2005) ("[a] malpractice claim brought against a governmental entity is governed solely by the medical malpractice act"). 132. it is worth noting that the defense of sovereign immunity is unavailable to municipally employed emts since the itca defines medical care as ministerial, which precludes it from itca protections: in a tort claim, "[a] governmental entity or an employee acting within the scope of the employee's employment is not liable if a loss results from[ ... ] [t]heperformance of a discretionary function; however, the provision of medical or optical care [ ... ] shall be con­ sidered as a ministerial act." § 34-13-3-3(7)(2006). 133. § 34-18-10et. seq. (1998); § 34-18-8-6 (1998). 134. ind. code§ 34-18-10-3 (1998). 135. § 34-18-10-8 (1998). 136. §34-18-10-17(1998). 137. § 34-18-10-22 (1998). 138. § 34-18-10-23 (1998). 139. §34-18-8-7(1998). 96 indiana heal1h law review [vol. 6:77 awards on health care providers. the total damage award for an act of malprac­ tice occurring after june 30, 1999 is $1,250,000,140 ofwhich the health care provider is liable for only $250,000.141 damages in excess of $250,000 are paid to the plaintiff out of the patient's compensation fund ("pcf").142 the pcf is comprised of the annual surcharge paid by all health care providers who participate under the act.143 the limitation on damages has survived a constitu­ tional challenge alleging that it denies due process oflaw by imposing an irre­ buttable presumption that the plaintitrs damages cannot exceed the limitation and precluding him from proving otherwise.144 according to the court, the li­ mitation is not a denial of due process because "[i]t is not a presumption which prevents recovery of more than that amount, but the policy of the law in the statute."145 the act is designed to curtail liability for medical malpractice, not to ex­ pand it.146 additionally, it does not create substantive rights or new causes of action; it requires that medical malpractice claims that are recognized under tort law and applicable statutory provisions be subjected to the procedures of the · act.147 "[t]he act only lays out the procedural mechanism for disposing of claims of medical malpractice; it does not alter the substantive law to be applied in the adjudication of those claims on the merits."148 thus, the litigation stage of a proceeding against a health care provider that is qualified under the act and one that is not are the same in all respects save two: the potential admission into evidence of the expert opinion from the medical panel and the available damages.t49 b. the patient's compensation fund the pcf is administered by the indiana department of insurance ("idof').150 the idol website provides a balance sheet and claim synopsis 140. § 34-18-14-3(a)(3)(1998). 141. § 34-18-14-3(b) (1998). 142. § 34-18-14-3(c) (1998). 143. § 34-18-6-1 (1998). 144. johnson, 404 n.e.2d at 599, overruled on other grounds by in re stephens, 867 n.e.2d 148 (ind. 2007); see st. anthony med. ctr., inc. v. smith, 592 n.e.2d 732, 739 (ind. ct. app. 1992) (plaintiff"contends that the act violates the due process clause of the united states and the state of indiana's constitution; violates the right to a jury trial; is an irrebuttable pre­ sumption; violates the equal protection and special legislation clauses; and, denies the right of access to the courts and the constitutional rights to a full and complete remedy. our supreme court has previously addressed these issues in johnson .•• and we are bound by its finding that the act is constitutional.'') 145. johnson, 404 n.e.2d at 600. 146. chamberlain v. walpole, 822 n.e.2d 959, 963 (ind. 2005) (citing johnson, 404 n.e.2d at 589). 147. atterholt v. robinson, 872 n.e.2d 633, 640 (ind. ct. app. 2007). 148. cacdac v. west, 705 n.e.2d 506,510 (ind. ct. app. 1999). 149. ind. code§ 34-18-1-let seq (1998). 150. see generally idol: healthcare providers, indiana dept. of ins., available at 2009] laryngoscopes, lidocajne, and liabn.ity 97 covering the financial attributes of the pcf from 1975-2007.151 with little deviation, the judgment amounts paid from the pcf per year have consistently increased: from$425,000in 1978to$94,589,261 in2007.152 since its incep­ tion in 1975, the pcf balance has never run a deficit 153 in 2007, the pcf bal­ ance was $152,268,523.154 in 2006 and 2007, payments into the pcf exceeded payments out of the pcf by $43,545,882 and $56,963,864, respectively.155 overall, the statistics from the pcf report indicate that the financial integrity of the pcf is secure for the foreseeable future.156 vi. the policy considerations driving immunity the position of this note is that some immunity protections are warranted for indiana ems providers. the following are some of the policy considera­ tions in support of the proposed immunity. a. the state of ems in indiana in september 2007, a purdue university research team published the re­ sults of the 2007 indiana emergency medical services survey.157 the survey was funded by the indiana state department ofhealth and the u.s. department of health and human services.158 the survey was administered to a sample of indiana ems personnel holding at least an emt -basic certificate.159 the re­ sults paint a picture of an ems system with a number of potentially problematic attributes that may bear on the appropriateness (or inappropriateness) of the current civil liability scheme for indiana's ems providers. the average survey respondent was forty years old; 72.3% were male, 72.7% were married, and 60.7% hadchildrenathome.160 overall, vacancy rates are high: twenty percent of emt -basic and twenty-five percent of emt­ paramedic positions are unfilled.161 over ninety percent of both paid depart­ ments and volunteer departments report that hiring is either ''very difficult" or http://www.in. gov/idoi/2385.htm. 151. indiana dep't. of ins., indiana patil!nt's compensation fund: annual report for2007, http://www.in.gov/idoilfileslpcf_annual_report_2007.pdf(last visited jul. 7, 2008). 152. id at2. from 1975-1977,nojudgmentswerepaidoutofthepcf. ld. 153. id. 154. ld. 155. ld. 156. this note does not address the propriety ofems participation under the act. the act is covered for the purpose of considering its utility as a potential indemnification device for ems providers. see discussion, supra section vi. 157. george avery, purdue unl:vbrsrry, 2007 indiana emergency men. serv. survey: chartbook (2007) [hereinafter ems survey: chartbook]; george avery, purdue university,indianaemergencymen.serv.needsassessment:workforceandtraining issues survey report (2007) [hereinafter ems survey: report]. 158. ems survey: char'i'book, supra note 157, atl. 159. emssurvey:report,supranote 157,at6. 160. id at7. 161. id 98 indiana health law review [vol. 6:77 "somewhat difficult. "162 almost forty-two percent of ems organizations are staffed entirely with volunteers.163 over two-thirds of ems organizations are affiliated with fire departments, and another 18.6% are hospital-based.164 those who administered the survey offered the most significant findings re­ garding ems personnel: evidence exists of a shortage ofems personnel in indi­ ana due to high vacancy rates. this is particularly acute in volunteer organizations, which report the greatest dif­ ficulty in recruiting ems personnel. paid ems person­ nel work on average significantly more than a standard 40 hour week, and high percentages of ems personnel add a second job. because excessive working hours have been linked to low quality healthcare, this may in­ dicate potential problems with the quality of ems care.•6s additionally, the report concludes that "[t]he training environment, both in terms of initial and continuing training, is so varied that it cannot realistically be considered a 'system,"'166 and that "[s]elf-assessmentofpreparedness levels by ems personnel reveals that the ems system in rural areas is likely to be less prepared and capable than in urban areas."167 finally, of those emts who in­ tend to leave their ems positions within the next year, 9.1% cited "legal liabili­ ty issues" as one of their reasons.168 b. other statutory grants of immunity 1. indiana code section 16-31-6-4: immunity in disaster emergency immunity from liability for ordinary negligence is not foreign to the indi­ ana code. in the event of a disaster emergency resulting from terrorism, 169 emts in indiana are not liable for acts or omissions in the provision of medical care that constitute ordinary negligence.170 at first glance, granting immunity in these situations seems warranted, whereas general immunity does not. the reality, however, is otherwise. the differences between providing ems care 162. ems survey: chartbook,supranote 157, at 16 tbl. 2.2.1. 163. ems survey: report, supra note 157, at 6. 164. ld at1. 165. id at3. 166. id at 13. 167. id at 14. 168. ems survey: chartbook, supra note 157, at 102. 169. the governor's disaster emergency declaration is governed by§ 10-14-3-12 of the indiana code. see ind. code ann.§ 10-14-3-12 {2004). 170. ind. code§ 16-31-6-4 (2004). 2009] larynooscopes, lidocaine, and liability 99 during a disaster and providing ems care under "ordinary'' circumstances are insufficient to warrant disparate treatment between the two. emergency medi­ cal care, regardless of when it is rendered, is a demanding and rigorous exercise in patient management, diagnosis, treatment, and transportation. in the same ems survey quoted in the preceding section of this note, over eighteen percent of indiana emts planning to leave ems within the next year cited "ems­ related stress" as a reason.171 another eighteen percent cited "[p]hysical de­ mands of ems work" as a reason. 172 there is no readily distinguishable differ­ enceat least one warranting separate immunity standards-between an emt rendering medical care at the site of an explosion caused by a gas leak and a site where explosives were placed intentionally. 2. indiana code section 34-30-12-l(b): good samaritan law another immunity provision in the indiana code relevant to the consider­ ation of immunity for emts is the good samaritan law.173 the law provides that: a person who comes upon the scene of an emergency or accident or is summoned to the scene of an emergency or accident and, in good faith, gratuitously renders emergency care at the scene of the emergency or acci­ dent is immune from civil liability for any personal in­ jury that results from: (1) any act or omission by the person in rendering the emergency care; or (2) any act or failure to act to provide or arrange for further medical treatment or care for the injured person; except for acts or omissions amounting to gross negligence or willful or wanton misconduct.174 beckerman v. gordon marked the first opportunity for an indiana court to ana­ lyze the provisions of the good samaritan lawp5 even though that case inter­ preted language that has subsequently been repealed by the indiana general assembly, the principles of statutory construction it lays out regarding the good samaritan law are instructive in considering the statute in its current ma­ nifestation. first, "[w]hen construing statutes in derogation of the common law [as the good samaritan law is], the statute is strictly construed against limita­ tions on a claimant's right to bring suit."176 further, ''when such a statute is 171. ems survey: chartbook, supra note 157, at 102. 172. id 173. ind. code § 34-30-12-1 (2006). 174. id. 175. beckerman v. gordon, 614 n.e.2d 610,612 (ind. app. ct. 1993). 176. id. (citing tittle v. mahan. 582 n.e.2d 796 (ind. 1991)). 100 indiana heal til law review [vol. 6:77 enacted, [the court] presume[s] the legislature was aware of the common law and that it did not intend to make any changes beyond those contained in the express terms or unmistakable implications of the statute."177 with the court's strict construction mandate in mind, the relevant inquiry is the scope of immunity provided to emts under indiana's current good sa­ maritan law. the civil liability statute providing that an emt ''who provides emergency medical services to an emergency patient is not liable for an act or omission in providing those services unless the act or omission constitutes neg­ ligence or willful misconduct"178 makes no effort to distinguish between emer­ gency care provided by on-duty and off-duty emts. therefore, the good samaritan law arguably cannot be used to immunize an off-duty emt from liability for ordinary negligence in rendering emergency care at the scene of an emergency. to repeat the court's charge in beckerman: in interpreting the good samaritan law, the court will "presume the legislature was aware of the common law and that it did not intend to make any changes beyond those con­ tained in the express terms or unmistakable implications of the statute."179 if the court presumes the legislature is aware of the common law, it most certainly presumes the legislature is aware of legislation, or statutory law. section 1631-6-1 explicitly and unambiguously levies civil liability against negligent emts. the good samaritan law fails to expressly or unmistakably set aside this express statutory liability ofemts, on-duty or off-duty. here, the anomalous nature of the explicit grant of liability for ordinary negligence found in§ 16-31-6-1 once again rears its ugly head. absent this statutory imposition of liability, the good samaritan law would presumably abrogate an emt' s common law liability for ordinary negligence when render­ ing care "gratuitously'' and "in good faith." as long as the statutory imposition of liability remains in place, however, the liability ofemts for ordinary negli­ gence would seem unaffected by an invocation of the narrowly-construed good samaritan law. this is undoubtedly a strange result. in passing good samaritan laws, the animating legislative purpose is to "encourage physicians, and sometimes oth­ ers, including laypersons, to render emergency care at the scene of an accident without fear of common law liability if they fail to exercise reasonable care when providing the emergency care."180 the current statutory arrangement is such, however, that it provides no immunity protection to emts, quite certainly some of the very people whose gratuitous emergency assistance the legislature had hoped to encourage. an off-duty emt assisting at an emergency scene will be exposed to a greater degree of liability than his non-emt counterparts; the safest choice for an off-duty emt would be to not render gratuitous assis­ tance at an accident or emergency. 177. id. 178. ind. code§ 16-31-6-l(a)(2003). 179. beckerman, 614 n.e.2d at 612. 180. id 2009] laryngoscopes, lidocaine, and liabn.jty 101 c. the role of firefighter/emf's the maintenance of a standard of ordinary negligence against emts be­ comes substantially more complicated after considering the extensive overlap between ems and the fire service. over two-thirds oflndiana's ems organiza­ tions are fire departments.181 many, if not most, of the ems providers at these fire departments will also be firefighters. under the itca, 182 "an employee acting within the scope of the employee's employment is not liable if a loss re­ sults from[ ... ] [t]he performance of a discretionary :function."183 also under the itca, firefighters are generally immune from suit for losses resulting from the exercise of their official duties.184 the itca, however, specifically ex­ empts the provision of medical care from the activities for which it provides immunity protections. 185 the result is that a firefighter/emt has immunity for firefighting and rescue efforts, but not for subsequent emergency medical care. this strange arrangement is impractical and would seem to discourage a firefighter/emt from performing or assisting in emergency medical care unless under a preexisting duty to do so. in any rescue situation, there are likely both fire and ambulance personnel on scene. if the fire crew is composed of fire­ fighter/emts, a well-advised firefighter/emt will act only up to the limits of firefighting and rescue services, and cease at the initiation of medical care. this is a problematic outcome in and of itself, in that the best patient care flows from the collaboration and assistance of all personnel on scene, but it also illu­ strates another potential problem with these competing schemes ofliability-at what point does rescuing someone end and medical care begin? though there is little statutory guidance on "medical care" as used in the itca, the indiana code does define "health care" in a number of places: as defined in the section addressing patient consent, health care means "any care, treatment, service, or procedure to maintain, diagnose, or treat an individual's physical or mental condition."186 in the definitions accompanying the act, "health care" is defined as "an act or treatment performed or furnished, or that should have been performed or furnished, by a health care provider for, to, or on behalf of a patient during the patient's medical care, treatment, or confine­ ment."187 in the definition section for the "civil law and procedure" title of the indiana code (the title containing the itca), one of the definitions prof­ fered for "health care services"188 is "any services by individuals certified as" 181. ems survey: report, supra note 157, at 7. 182. ind. code§ 34-13-3-3 (2006). 183. ind. cone§ 34-13-3-3; § 34-13-3-3(7). 184. see generally fowler v. brewer, 773 n.e.2d 858 (ind. ct. app. 2002). 185. ind. code§ 34-13-3-3(7) (2006) ("[t]he provision of medical or optical care as provided in ic 34-6-2-38 shall be considered as a ministerial act''). 186. § 16-36-1-1 (1993). 187. § 34-18-2-13 (1998). 188. the title offers no definition for ''medical care.'' see§ 34-6-2 (2007). 102 indiana healm law review [vol. 6:77 emts. 189 "[h]ealth care" or ''health care services" likely encompasses more actions than "medical care," complicating the inquiry into exactly what consti­ tutes "medical care" for purposes of governmental immunity. for example, if a passenger in a motor vehicle accident needs to be extri­ cated, and a firefighter is positioned behind the passenger in order to hold and stabilize the passenger's cervical spine, does that constitute medical care? if indiana defines "medical care" too broadly under the itca. rescue activities that the legislature could hardly have intended to exclude from the protections of governmental immunity could plausibly fall outside of its protections. since the indiana code provides no guidance on the scope of "medical care," a foray into an english language dictionary is warranted. the first defi­ nition proffered in the merriam-webster online dictionary for "medical" is: "of, relating to, or concerned with physicians or the practice ofmedicine."190 similarly, the american heritage dictionary defines "medical" as: "[ o ]for re­ lating to the study or practice of medicine. "191 as shaped by the definitions from these (concededly, non-legal) sources, a reasonable working definition for ''medical care" is care which constitutes the practice of medicine. such a defi­ nition also conforms to a plain reading of the text. even armed with what appears to be a straightforward working definition for ''medical care," it remains difficult to determine how a court might categor­ ize the activities that a firefighter/emt performs at a typical fire and/or rescue operation. there is no way to predict where a court might draw the line in de­ termining what constitutes "medical care" in a situation with as much fluidity as a rescue scenario involving personnel who are both firefighters and emts. the difficulty of predicting the scope of "medical care" as it relates to the itca leaves open the possibility that a court could apply governmental immunity pro­ tections to emergency medical actions that fall short of constituting the practice of medicine. d. the prevalence of shiftwork as long as the public requires around-the-clock emergency medical ser­ vices, shiftwork will remain an unavoidable necessity in ems. shift duration can include lengths of eight, ten, twelve, fourteen, sixteen, or twenty-four hours, with ems providers working an average of fifty-four total hours per week.192 long work hours, like those required in ems, "have been clearly 189. § 34-6-2-55 (2006). 190. merriam-webster 0nunb dictionary, available at http://www.merriam­ webster.com/ dictionary/medical. 191. american heritage dictionary oftijb english language (4th ed. 2000), avaifa.. bleat http://www.bartleby.com/61/8/m0190800.html. 192. int'lassoc. of fire chiefs, dm effects of sleep deprivation on fire fighters and ems responders 46-47 (2007), http://www.iafc.org/associations/4685/files/ progssleep_sleepdeprivationreport.pdf (last visited jul. 7, 2008) [hereinafter sleep deprivation report). 2009] laryngoscopes, lidocaine, and liability 103 linked to errors in tasks that require vigilance and focused alertness, such as driving an ambulance and providing patient care."193 furthermore, "[t]he epi­ sodic and unpredictable nature of [ems] work is associated with fragmented sleep and overall increase in fatigue."194 the consequences of sleep deprivation are profound: [g]etting fewer than six hours of sleep during one sleep­ wake cycle can affect coordination, judgment and reac­ tion time [ ... ] [t]he performance of a sleep-deprived worker is similar to that of an intoxicated person. [p]eople with 24 hours of sustained wakefulness [per­ form] tasks [ ... ] at a level comparable to those with 0.10% blood-alcohol content. 195 in addition to sleep deprivation, ems shiftwork also creates an "increased risk of depression, hypertension, digestive disorders, immunosuppression, diabetes, obesity and a host of other mental and physical health problems. "196 while ems organizations can take steps to mitigate the harmful effects of sleep depri­ vation on emt health and work performance, the nature of ems work will al­ ways require emts to push their cognitive and physical capabilities beyond normal bounds. e. administrative liability this note takes the position that indiana ought to provide some sort of immunity from liability to emts. the probable rallying cry of those who would oppose such a proposal is that, by providing immunity, the state effec­ tively condones the negligent acts of its ems personnel. those alarmed by any potential vacuum in culpability need look no further than the indiana adminis­ trative code ("iac") for solace. the lac expressly provides that "[a]n emer­ gency medical technician shall not act negligently, recklessly, or in such a manner that endangers the health or safety of emergency patients or the mem­ bers of the general public."197 enforcement of this administrative liability falls to the indiana department ofhomeland security, which may, as the agency that 193. w. ann maggiore, sleep deprivation study details effects ofshiftwork in ems, j. emergency med. servs. (nov. 2007), available at http://www.jems.com/news _and _articles/ columns/maggiore/sleep_ and_ shiftwork.html (citing sleep deprivation report, supra note 191). 194. !d. 195. terry nugent, around the clock: the effect of night shifts on your health and sqfe­ ty, j. emergency med. servs. 92100 (mar. 2007), available at http://www .jems.comllmages/march_ 2007 _around_ the_ clock_ tcm16-90471.pdf. 196. maggiore, supra note 193. 197. 8361nd. admin. code§ 4-4-l(e)(2) (2004). 104 indiana health law review [vol. 6:77 issues ems certifications, take action against an ems provider's certification, including suspension, revocation, or requiring remedial education.198 thus, administrative liability for negligence provides a safety net to ensure the same standard of care as civil liability does, but in a more appropriate way-levying administrative penalties against providers and organizations, ensuring a reason­ able standard of care without imposing the burdens of civil liability upon over­ worked and underpaid public safety personnel. vii. conclusion given the copious legal and policy considerations, a grant of immunity to emts from civil liability for acts of ordinary negligence is appropriate. the possible avenues through which to achieve this end are as numerous as the sta­ tutes which touch upon prehospitalliability. the first and best option is an ex­ plicit statutory grant of immunity in place of the particularly anomalous indiana code § 16-31-6-1. explicit statutory immunity is the path chosen by all of the states surrounding indiana, 199 and is the one that most unambiguously confers immunity upon emts. such a statute allows the general assembly to endorse the abundant policies supporting immunity and to encourage ems providers to enter the field without an unreasonable risk oflegalliability. if the current sta­ tute remains unchanged, the continued existence of this code provision mandat­ ing liability for negligence serves as a potential stumbling block for an attempt to confer immunity via any other statute. the general assembly may also revisit the itca provision excluding "medical care" from governmental immunity protections as another option. since the itca currently contains no definition for "medical care,'.2oo the legis­ lature could explicitly exclude prehospital emergency medical services from such a definition. this simple definitional change would bring emts into the fold of governmental immunity conferred by the statute. this approach would not apply to private ems agencies, an obvious weakness. such a result is less satisfactory than giving an express statutory grant of immunity to all emts, but private ems agencies may be better situated to absorb the financial impact of a civil judgment rendered against them. the general assembly may also opt to use the indiana medical malprac­ tice act, specifically the patient's compensation fund, as a tool of indemnity. given the patient's compensation fund's ostensible financial solvency,201 the general assembly could amend the act to provide for funds to be drawn from it to pay judgments rendered against emts for acts of ordinary negligence re­ lating to prehospital care. this proposal requires no revision to§ 16-31-6-1 because that section's liability and this indemnity can exist simultaneously, and 198. see generally 8361nd. admin. code § 4-4-1 et seq. (2007). 199. see part iv .a, infra. 200. see part vi.c, infra. 201. see part v.b, infra. 2009] laryngoscopes, lidocaine, and liability 105 indemnity ensures that patients receive compensation for their injuries without imposing the fmancial burdens of civil judgments on already-strained ems sys­ tems. the lack of indiana ems providers questioning the general assembly's willingness to put them out on a limb with this strange statutory liability likely corresponds to a lack of negligence actions brought against emts generally. claims filed against emts, however, are on the rise and the existence of civil liability for ordinary negligence discourages people from pursuing work in ems by encouraging unnecessarily expansive liability against them. the gen­ eral assembly must re-visit the issue of liability for prehospital providers or else risk undermining policy goals as related to the fostering of public safety in indiana. nicolas p. terry, b.a. (hons) law, ll.m. chester a. myers professor of law, saint louis university school of law nicolas p. terry is the chester a. myers professor of law at saint louis university school of law where he teaches torts, products liability, health information technology, law & science, and health care quality. educated at kingston university and the university of cambridge, profes­ sor terry began his academic career as a member of the law faculty of the university of exeter in england. he has served as a senior fellow at mel­ bourne law school and holds the secondary appointment of professor of health management & policy at the saint louis university school of pub­ lic health. he has held visiting faculty positions at the law schools of santa clara university, the university of missouri-columbia, washington uni­ versity, and the university of iowa. from 2000-08 professor terry served as co-director of saint louis university's center for health law studies­ consistently ranked by u.s. news & world report as the finest health law program in the nation. from 2008-10 terry served as the school of law's senior associate dean. professor terry's research interests lie primarily at the intersection of medicine, law, and information technology. his recent law review publications dealing with health information privacy include "physicians and patients who 'friend' or 'tweet': constructing a legal framework for social networking in a highly regulated domain," http://works.bepress.com/nicolas_terry/1 43 ind. l. rev. 285-341 (2010); "personal health records: directing more costs and risks to consumers?" 1 drexel l. rev. 216 (2009); "what's wrong with health privacy?" 5 j. health & bio. l. 1-32 (2009), and "ensuring the privacy and confidential­ ity of electronic health records" (with leslie p. francis) 2007 u. ill. l. rev. 681-735. certification and meaningful use: reframing adoption of electronic bealm records as a quality imperative nicolas p. terry• i. in'ir.oduction ................................................................................. 46 ii. electronic records and market f allure ............................... 47 ill. arra and hitech subsidffis ...................................................... 49 iv. regulatingehraooption .......................................................... 50 a. meaningful use .......................................................................... 51 b. certification ............................................................................... 57 v. improving quali1y: a broader frame for meaningful use .... 61 vi. conclusion .................................................................................... 66 abstract this article examines the promise of the health information technol­ ogy for economic and clinical health act ("hitech'') to reduce or elimi­ nate the market failures that have impeded the adoption of electronic health records ("ehr"). specifically, the article considers a key provision of the statute, a condition for receiving ehr subsidy funds, namely mean­ ingful use. this deceptively simple requirement, that a health care provider must make "meaningful use of certified ehr technology," has become both the regulatory core and the talisman for the next decade's implementation of health information technology. this article describes the background of the subsidy program and examines the specifics of the "certification" and "meaningful use" regulations that have followed. the article concludes by taking a broader view of ''meaningful use" and relating it to the concept of more fundamental health care reform. the provisions of the hitech act are best under­ stood not as investments in technology per se, but as efforts to improve the health of americans and the performance of their health care system . . . . com­ bined, [the hitech] programs build the foundation for every american to benefit from an ehr, as part of a modernized, interconnected, and vastly improved • chester a. myers professor of law, saint louis university. email: ter­ ry@slu.edu. i thank gina marie geheb, karla hutton, and professor margaret mcdermott for their excellent research assistance. 46 indiana health law review [vol. 8:43 system of care delivery. 1 i. introduction notwithstanding the 2004 commitment of president bush to the adop .. tion of a national electronic health records ("ehr") system, by 2009 only seventeen percent of u.s. doctors and ten percent of hospitals had even basic ehr systems2 and fewer than two percent of u.s. hospitals had com­ prehensive systems. 3 furthermore, health care providers continue to lag in technologies related to ehrs. for example, only thirteen percent of hospi­ tals have implemented computerized provider-order entry ("cpoe") tech­ nology.4 according to dr. david blumenthal, the current national coordinator for health information technology ("onc"),5 "we have years of professional agreement and bipartisan consensus regarding the potential value of ehrs. yet we have not moved significantly to extend the availa­ bility of ehrs from a few large institutions to the smaller clinics and prac­ tices where most americans receive their health care.',(i this article examines the promise of the market-failure-busting poten­ tial of the health information technology for economic and clinical health act {"hitech").7 specifically, it looks at a key provision of hitech: the ''meaningful use" condition required to receive ehr subsidy funds. this deceptively simple requirement, that a health care provider must make "meaningful use of certified ehr technology,',s has become both the regulatory core and the talisman for the next decade's implementa1. efforts to promote the adoptions and meaningful use of health information technology: hearing before the subcomm. on health of the h. comm. on ways and means, lllth cong. 3 {2010) [hereinafter hearings] (statement of david blumenthal, m.d., m.p.p., national coordinator, off. of the nafl coordinator for health it, u.s. dep't of health and human services), available at http://waysandmeans.house.gov/media/pdf/11l/2010jul20 _blumenthal_ testimony. pdf. 2. david blumenthal, stimulating the adoptwn of health informatwn technology, 360 new eng. j. meo. 1477, 1477 (2009); see also sean 0. hogan & stephanie m. kissam, measuring meaningful use, 29 healthaff. 601,603 (2010). 3. ashisb k. jba, et al., use of electronic health records in u.s. hospitals, 360 new eng. j. med.l628, 1634 (2009), see also hogan & kissam, supra note 2, at 601. 4. jba et al., supra note 3, at 1635. 5. see generally about the office of the natwnal coordinator for health information technology (onc), u.s. dep't of health and human services, http:/ lbealtbit.hbs.gov/portal/server.pt/communitylbealthit_ hbs _gov _ onc/1200 (last updated aug. 13, 2010) (explaining that the office of the national coordinator for health information technology (''onc") is a federal agency located in the u.s. department of health and human services ("hhs'')). 6. david blumenthal & marilyn tavenner, the "meaningful use" regulation for electronic health records, 363 new eng. j. med. 501, 501 (2010). 7. title xiii (health information technology for economic and clinical health act, "hitechj of the american recovery and reinvestment act of 2009 (" aara"), pub. l. no. 111-5, 123 stat. 115,226-79 (2009) (codified in scattered sections of 42 u.s.c.). 8. 123 stat. at 494. 2011] reframing adoption of electronic health records 47 tion of health information technology ("hit").9 this article considers the background of the ehr subsidy program and examines the specifics of the "certification" and "meaningful use" regulations that have followed. the article concludes by taking a broader view of "meaningful use" condition and relating it to the concept of more fundamental health care reform. ll. electronic records and market f allure while the most frequently cited reason for hit's low adoption rate has been high cost, the far more nuanced barrier has been market failure, even multiple market failures. in discussing costs, the electronic record cost-benefit picture has always been opaque. for example, estimates for implementing a national system have been as high as $400 billion.10 yet, many of the projected savings after successful implementation of fully in­ teroperable records, such as decreases in medical error, reductions in dupli­ cate tests, and research into health outcomes, 11 are more diffuse and almost impossible to track to a provider's bottom line. further, some benefits are based only indirectly on ehr technologies and are dependent on the im­ plementation of other (and not inexpensive) hit modules that interact with records systems, such as cpoe and clinical decision support systems ("cdss") technologies.12 for ehr, the most obvious market failure (and a familiar one in u.s. health care analysis) has been ''misaligned incentives." 13 much of the sav­ ings from ehr will accrue to payers, such as health insurers, rather than the health care providers actually investing in the technology. as a result, it 9. see generally nicolas p. teny, to hipaa, a son: assessing the technical, con­ ceptual, and legal frameworks for patient safety i'lformation, 12 widener l. rev. 133 (2005); comm. on quality of health care in am., instl1ute of med., crossing the quality chasm: a new health system for the 21st ceniury 164-80 (2001) [hereinaf­ ter institute of med.]; .aaron mckethan et al.,the bipartisan pol'y ctr., improving quauty and value in the u.s. health care system (2009), available at http://www.bipartisanpolicy.org/sites/default/files/bpc8-09-pchco/o20qualo/o20rpt-8-2009.pdf. 10. peter basch, electronic health records and the national health information network: affordable, adoptable, and ready for prime time?, 143 annals of internal med. 227, 227 (2005); see also rainu kaushal et al., the costs of a national health information network, 143 annals of internal med. 165 (2005). 11. see fact sheet, centers for medicare & medicaid services office of public affairs, electronic health records at a glance (july 13, 2010), available at, http://www.cms.gov/apps/media/press/factsheet.asp?counter=3788&intnumperpage=10&c heckdate=&checkk.ey--&srchtype=1&numdays=3500&srchopt=o&srchdata=&keywordt ype=all&chknewstype=6&intpage=&showall=&pyear-&year-&desc--&cboorder-date [hereinafter fact sheet: ehr] (noting some of the projected benefits ofehrs). 12. see generally david w. bates et al., effect of computerized physician order entry and a team intervention on prevention of serious medication errors, 280 jama 1311-1316 (1998) (discussing the patient safety benefits of cpoe); institute of med., supra note 9. 13. see steven m. teutsch & marc l. berger, misaligned incentives in america's health: who's minding the store?, 3 annals off am. med. 485, 485-87 (2005). 48 indiana health law review [vol. 8:43 has been difficult to make the business case for the adoption of ehr prod­ ucts and their total cost of ownership (''tco"), such as hardware and software updates, personnel, training, and technical support.14 the com­ pounding market failure, the ''network effects" phenomenon, likely has con­ tributed to the lack of provider enthusiasm for investing in ehr technology. 15 the marginal value for an individual provider to seek out a network-ready ehr is very low when so few (marginal at best) systems have been deployed.16 the exception proves the rule-vertically integrated providers and some multispecialty groups have undertaken such investment because they possess the economies of scale required for advanced it de­ ployment and are often also insurers, thus aligning incentives.17 implementing a national interoperable ehr system became the cor­ nerstone of the bush administration's hit policy when the president per­ sonally committed to the ten-year goal that all americans would have electronic health records by 2014.18 although that administration was suc­ cessful in guiding many of the conceptual and standards issues to a success­ ful conclusion, it was not prepared to invest seriously in the endeavor, but rather relied on what it described as a "market-leading" approach.19 in 2005, the medical economist j.d. k.leinke concluded an essay in health affairs on the market failure associated with interoperable ehrs by suggesting, "[t]he federal government can and should write the huge check and be done with it.'120 by that stage, most stakeholders appear to have ac­ cepted the cost estimates published in a health affairs article in the fall of 2005: $44,000 purchase or capital cost per physician, plus $8,500 per phy14. see generally steven r. simon et al., correlates of electronic health record adoption in office practices: a statewide survey, 14 j. am. med. informatics ass'n, 110 (2007), available at http://jamia.bmj.com/content/14/l/llo.full.pdf.; david w. bates, physi­ cians and ambulatory electronic health records, 24 health aff. 1180 (2005), available at http:/ /content.healthaffairs.org/cgi/reprint/24/5/1180. 15. this issue also undermines the outcomes reporting potential ofehrs. see nancy ferris, health affairs & the robert wood johnson foundation, health poucy brief: 'meaningful use' of electronic health records 2 (2010), available at http://www.healthaffairs.org/healthpolicybriefslbrief_pdfs/healthpolicybrief_24.pdf. 16. a third but related type of market failure is the first mover/high information cost problem likely caused by having between 300 and 400 ehr vendors in the market. see helaine olen, the next tech goldmine: medical records, cnnmoney.com (march 5, 201 0), http://money.cnn.com/2010/03/05/smallbusiness/electronic _ medical_recordsl. 17. see generally steve lohr, digital health records: the hard road ahead, bits (sept 10, 2009, 7:19 pm), http:/lbits.blogs.nytimes.com/2009/09/10/digital-health-records­ the-hard-road-ahead/?hp. 18 .. press release, the white house office of the press secretary, transforming health care: the president's health information technology plan (may 27, 2004), http://georgewbush-whitehouse.archives.gov/news/releases/2004/05/20040527-2.html. 19. see e.g., robert cunningham, action through collaboration: a conversation with davidbrailer, 24healthaff. 1150, 1151-52 (2005). 20. j.d. kleinke, dot-gov: market failure and the creation of a national health information technology system, 24healthaff. 1246, 1258 (2005). 2011] reframing adoption of electronic health records 49 sician in annual costs, such as support and software updates.21 kleinke cor­ rectly tempered his enthusiasm for this bold stroke with a reality-based as­ sessment, "[w]riting a check for a quarter of a trillion dollars is pure po­ political fantasy . . . . the very idea of a public works project ... sounds like an artifact from an era eclipsed by nearly three decades of hostility to­ ward government-based solutions to domestic problems, combined with a seemingly religious belief in marketplace solutions for all ofthem.'m iii. arra and hitech subsidies four years later, a recession and growing financial crisis transformed fantasy into reality. when president obama signed the american recovery and reinvestment act of 2009 ("arra"), hitech was passed into law.23 hitech instructed the national coordinator for health information tech­ nology to update the federal health it strategic plan to include specific objectives, milestones, and metrics with respect to, inter alia, "[t]he elec­ tronic exchange and use of health information and the enterprise integration of such information" and "[t ]he utilization of an electronic health record for each person in the united states by 2014."24 the core of the hit package is the stimulation of ehr adoption and encouraging state and regional in­ frastructure for the interoperability of such records?5 the arra hit funding provides roughly $30 billion for department of health and human services ("hhs") agencies: approximately $27 bil­ lion for the centers for medicare & medicaid services ("cms") and $2 billion for onc?6 with these budgets, cms will fund the ehr incentive program while onc will provide coordination and planning while also funding state and regional initiatives through grants and loans?7 medicaid 21. robert h. miller, et al., the value of electronic health records in solo or small group practices, 24 health aff. 1127, 1127 (2005). 22. kleinke, supra note 20, at 1257. 23. 123 stat. at 226-79. 24. !d. at 231. 25. kevin freking, obama team sees stimulus advancing health reform, associated press financial wire, feb. 14, 2009. 26. u.s. dep't of health and human services, off. of the nat'l coordinator for health info. tech., accelerating the adoption of health information technology implementation plan (2010), available at http://www.hhs.gov/recovery/ reports/plans/onc_hit.pdf; samhsa financing center of excellence, substances abuse and mental health administration, samhsa's weekly financing news pulse: national editionjuly 23, 2010 (2010), available at http://www.samhsa.gov/ financing/file.axd?file=20 1 0%2fl 0%2f20 10 _1 0 _ weeklyfinancingnewspulsenational edi­ tionfina120 1 00723.pdf. 27. hitech-funded programs include: the state health information exchange ("hie") cooperative agreement program (hie grants), the beacon community program (hit grants), the health it workforce program (education and curriculum development), the strategic health it advanced research projects ("sharp") program (grants to address barriers to hit adoption), and the health information technology extension program 50 indiana health law review [vol. 8:43 and medicare incentive payments will be made to non-hospital-based doc­ tors ("eligible providers" hereinafter "ep''fl and eligible hospitals. 29 for example, a physician who participates in the full five-year program could receive the maximum subsidy of $44,000 through medicare.30 hospital­ employed physicians are expressly excluded from the reimbursement op­ portunity as it is assumed they will have access to their hospital's ehr sys­ tems.31 hospitals themselves are eligible for reimbursement with a $2 million baseline and thereafter a formula based on the number of inpatient discharges.32 currently there are approximately 500,000 eligible providers and 5000 eligible institutions.33 the subsidy program only applies to 2011 through 2016, with incen­ tive payments declining after the first two years. starting in 2016, hitech's "carrots" will be replaced by ••sticks.'.j4 at that point, eps and hospitals that fail to use qualifying ehr.s for meaningful purposes will see reductions in their medicare and medicaid payments. iv. regulating ehraooption likely there were many forces that shaped the conditional nature of the ehr subsidy program including the broad politics surrounding the fed­ eral recovery program and latent skepticism about the worth of hit. as written, hitech provides that to quality for such payments the provider (grants to establish regional ''help desks"). for a breakdown of budgets for these programs, see david blumenthal, launching hitech, 5 new eng. j. med. 382, 383 (2010). 28. 123 stat. at467·77. 29. 123 stat. at 477-86. the subsidy program applies to both eligible hospitals and critical access hospitals ("caw'). for the purpose of this article, ''hospital" is used to refer to both. see generally critical access hospital frequently asked questions, rural assistance center., http://www.raconline.org/info _guides/hospitals/cah.php#faq (last updated oct. 26, 2010). 30. detailed provisions regarding incentive amounts are to be found at 42 c.p.r. § 495.102 (2010) (eps), 42 c.f.r § 495.104 (hospitals), and 42 c.f.r § 495.106 (cars). the medicaid option applies to physicians with at least thirty percent of medicaid patients. medicaid eps attract potentially different subsidies (up to $63,750 per physician) and a longer timeline (up to six years). 42 c.f.r. § 495.308 (indicating net average allowable costs under medicaid); § 4201, 123 stat. at 489·94; electronic health record incentive program, 75 fed. reg. 1,844, 1,935 (proposed jan. 13, 2010) (to be codified at 42 c.f.r. pts. 412, 413, 422, and 495) (indicating the maximum incentive payment amount for medicaid professionals). see also 42 c.p.r. § 4952 (noting specific hitech act authority for subsidies). 31. electronic health record incentive program, 75 fed. reg. at 1,907. 32. 42 c.f.r. § 495.104 (summarizing that, basically, the payments are made as an add-on to their medicare fees); jason fortin & walt zywiak, beyond meaningful use getting meaningful value from it, 64 hi!althcare fin. mgmt. 54, issue 2 (2010) (estimating that final hospital incentives vary from between $2 million to $6 million); joseph goedert & howard anderson, digging into the economic stimulus law, health data mgmt., apr. 2009, at 16 (estimating the final value of hospital incentives to be between $2 million and $11 million). 33. ferris, supra note 15, at2. 34. /d. 2011] reframing adoption of electronic health records 51 must make a "meaningful use of certified ehr technology."35 this re­ quirement is being executed by regulations from onc and cms, which address certification36 and meaningful use, respectively.37 although the core program under the stimulus provisions was (and remains) the provision of incentives for ehr adoption, hhs clearly has taken its cue from the broader objectives detailed in the hitech acr8 and the national health care reform that was to follow a year later. as cms noted in its 2010 regulatory commentary, "reforming the health care system and improving health care quality, efficiency and patient safety should drive the definition of meaningful use."39 a. meaningful use cms, onc, and the hit advisory committees (specifically the mean­ ingful use workgroup, a subset of the health it policy committee40) devel­ oped the regulations by first drawing up a "meaningful use matrix." 41 the elements of this matrix are "objectives," "measures," and "stages.'o42 es­ sentially, the matrix is a functional reflection of meaningful use informed by hitech's broad health outcome goals. it ties together those broad out­ come goals, defined sub-goals (objectives), reporting tools that represent sub-goal compliance (measures) and the timeline for the project (stages).43 hitech's broad health outcome goals are: (1) improving the quality, safety, and efficiency of care while reducing disparities; (2) engaging pa­ tients and families in their care; (3) promoting public and population health; (4) improving care coordination; and (5) promoting ehr privacy and secu­ rity.44 the secondary elements ofthe matrix are the objectives under each 35. 123 stat. at 494. 36. see infra part n.b. 37. see infra part n.a. 38. hitech, pub. l. no. 111-5 § 3001(b), 123 stat. 115,353-73 (2009). 39. electronic health record incentive program. 75 fed. reg. 44, 314 (july 28, 2010) (to be codified at 42 c.f.r. pts. 412,413,422, 495). 40. health it policy committee (a federal advisory committee), u.s. dep't of health and human services, http://healthit.hhs.gov/portal/server.pt/community/ healthit_hhs_gov_health_it_policy_committee/1269 (last updated oct. 7, 2010). 41. fact sheet, centers for medicare & medicaid services office of public affairs, cms proposes definition of meaningful use of certified electronic health records (her) (dec. 20, 2009), available at http://www.cms.gov/apps/media/press/factsheet.asp? counter=3564&intnumperpage=1 o&checkdate=&checkk.ey=&srchtype= 1&numdays=35 oo&srch0pt=o&srchdata=&keywordtype=all&chknewstype=6&intpage=&showall=&p year=&year=&desc=false&cboorder--date [hereinafter fact sheet: cms proposes]. 42. id 43. see generally bob brown, the definition of "meaningful use", j. health care compliance, sept.-oct. 2009, at 45. 44. see generally letter from paul tang, vice chair, health it pol'y comm., to david blumenthal, md, mpp, nat'l coordinator for health info. tech., off. of the nat'l coordinator, dep't health and human services, (aug. 10, 2009) available at http://www.google.com/search?client=safari&rls=en&q=paul+tang+to+david+blumenthal+a 52 indiana health law review [vol. 8:43 of these goals. for example, "improving quality" includes "access to com­ prehensive patient health data for patient's health care team" and use of "evidence-based order sets and cpoe.'.45 the third elements of the matrix, "measures" provide criteria or met­ rics (typically a usage "floor") to report progress towards the objectives.46 the final element, set against these objectives and measures, is a three­ stage program timeline, with stage l beginning in 2011, stage 2 beginning in 2013, and stage 3 beginning in 2015.47 cms published its proposed rule in january 2010.48 the proposed rule mandated twenty-three objectives for hospitals and twenty-five for cli­ nicians. criticisms and comments were legion. in march 2010, 249 mem­ bers of congress signed a letter to cms urging the agency to revise meaningful use with a "narrow[er] base" of 2011 objectives and an exten­ sion of the transition to 2017.49 the letter stated: [the proposed rule is] an ambitious ali-or-nothing ap­ proach in which hospitals would be required to adopt all 23 separate ehr objectives ... that very few hos­ pitals have yet been able to accomplish. the rule should be altered to recognize a practical, staged ap­ proach to ehr adoption that rewards the efforts al­ ready underway in america's hospitals. 50 the primary objection among stakeholders was that cms had taken an "all or nothing" approach; "doctors could not have received any federal bonus payments unless they met 25 criteria, or objectives, and hospitals would have been required to meet 23.''51 a second objection was that cms ugust+10,+2009&ie=utf-8&oe=utf-8; blumenthal, supra note 27; news release, u.s. department of health & human services press office, cms and onc issue regulations proposing a definition of 'meaningful use' and setting standards for electronic health record incentive program (dec. 30, 2009), available at http://www.hhs.gov/news/press/ 2009pres/12/20091230a.html; brown, supra note 43, at 72; catherine m. desroches & sara j. rosenbaum, meaningful use of health information technorogy in u.s. hospitals, 362 neweng.j.med.l153 (2010). 45. electronic health record incentive program, 75 fed. reg. 44, 314, 44,331 (july 28, 2010) (to be codified at 42 c.f.r. pts. 412,413,422, 495). 46. 42 c.f.r. § 495.6 (2010). 47. fact sheet: cms proposes,supranote41; blumenthal, supranote27, at 382. 48. electronic health record incentive program, 75 fed. reg. 1,844, (proposed jan. 13, 2010) (to be codified at42 c.f.r. pts. 412,413,422, and 495). 49. letter from u.s. congress members to charlene frizzera, acting administer, cms (feb. 24, 2010), available at http://www.aha.orglahalcontent/2010/pdf7100224 dear­ colleaguehit.pdf. 50. id. 51. robert pear, standards issued for electronic health records, n.y. times, july 13, 2010, at al6, available at http://www.nytimes.com/2010/07/14/healthlpolicy/14health.html? _r=2&ref=technology; see also pamela lewis dolan, "meaningful use" takes time (himss 2010 conference), amednews.com (april 19, 2010), http://www.ama·assn.org/ amednews/20 1 0/04/19/bisa0419 .htm. · 2011] reframing adoption of eleci'ronic health records 53 had created a very difficult target; what the regulators had listed as stage 1 objectives were viewed as more appropriate for stage 3 (2015) and thereaf­ ter.52 it was argued, for example, that fewer than six percent of physician practices would meet the proposed meaningful use criteria. 53 notwithstand­ ing, there were some more muted criticisms that the proposed rule did not go far enough. for example, during a hearing in july 2010 before a sub­ committee of the house ways and means committee, two republican congressmen challenged dr. blumenthal on the appropriateness of the measure for interoperability;54 specifically, that the interoperability objec­ tive (the "[c]apability to exchange key clinical information"i5 could be successfully measured by a single exchange of proxy data. 56 dr. blumen­ thal stood his ground on the basis that such interoperability was a function of infrastructure building outside the control of an ep. 57 the final rule was published in july 2010.58 at this time cms noted that the rule now used a ''phased approach ... [that] initially establishes criteria for meaningful use based on currently available technological capa­ bilities and providers • practice experience. "59 thus, the final rule backped­ aled from the "all or nothing" approach of the initially proposed rule. instead, for the first two years of the funding program cms has established a two tier model: first, a set of fifteen "core objectives" that eligible provid­ ers and hospitals must satisfy to qualify for ehr funding, and second, a "menu set" of ten objectives (twelve for professionals) from which five must be chosen and fulfilled. 60 as noted in the media, "standards in the new rules are less demanding 52. joseph goedert, meaningful use: this is gonna hurt, 18 health data mgmt. 40 (2010); brown, supra note 43, at 45-46, 72; barbara j. hoehn, meaning/ill use: what does it mean for healthcare organizations?, 24 j. healthcare info. mgmt. 11 (2010). 53. goedert, supra note 52, at 42. see also ferris, supra note 15, at 5. see generally william s. bernstein et al, manatt health solutions, hitech revisited, (june 2010), available at http://www.manatt.com/uploadedfiles/news_and_events/newsletters/ hea1thlaw@manattlllltech%20revisited_final%20may"lo2031,%202010.pdf. 54. hearings, supra note i (statements of reps. berger and johnson, members, h. comm. on ways & means). 55. 42 c.f.r. § 495.6(d)(l4)(i) (2010). 56. id. 57. hearings, supra note i (statement of david blumenthal, m.d., m.p.p., nat'l co­ ordinator, off, of the nat'l coordinator for health it, u.s. dep't of health and human ser­ vices). 58. electronic health record incentive program, 75 fed. reg. 1,844, 1,935 (proposed jan. 13, 2010) (to be codified at 42 c.f.r. pts. 412,413,422, and 495). 59. fact sheet, centers for medicare & medicaid services office of public affairs, cms and onc final regulations define meaningful use and set standards for electronic health record incentive program (july 13, 2010), available at http://www.cms.gov/apps/ medialpresslfactsheet.asp?counter=3787&intnumperpage=lo&checkdate=&check key=&srchtype= l&numdays=3500&srch()pt=o&srchdata=&keywordtype=all&chknew stype=6&intpage=&showall=&py ear-&year=&desc=false&cboorder-date [hereinafter fact sheet: cms defines mu]. 60. id 54 indiana health law review [vol. 8:43 and more flexible."61 in its own introduction to the final rule, cms tried hard to disguise disappointment that its more radical proposals had been delayed," by having [continuous quality improvement and ease of information exchange] in certified ehr technology at the onset of the program and requiring that the ep eligible hospital or cah become familiar with them through the varying levels of engagement required by stage 1, we believe we will create a strong foundation to build on in later years.62 the final rule promulgates parallel groups of objectives (criteria), one for eps,63 and the other for eligible hospitals.64 each group of objectives includes a series of core (or mandatory) criteria and a series of menu crite­ ria.65 each criterion is accompanied by an outcome measure and, in a few cases, exclusionary criteria detailing when a provider does not have to com­ ply with a particular objective.66 for example, the fifteen objectives in the ep core set67 include the use 61. pear, supra note 51, at al6. 62. electronic health record incentive program, 75 fed. reg. 44, 314, 44,321 (july 28, 2010) (to be codified at 42 c.f.r. pts. 412,413,422, 495). 63. 42 c.f.r. § 495.6(d) (2010) (stage 1 core criteria for eps); 42 c.f.r. § 495.6(e) (stage i menu set criteria for eps). 64. 42 c.f.r. § 495.6(1) (stage 1 core criteria for eligible hospitals); 42 c.f.r. § 495.6(g) (stage 1 menu set criteria for eligible hospitals or cahs). 65. !d. 66. 42 c.f.r. § 495.6(a)(2)-(3) (eps); 42 c.f.r. § 495.6(b)(2)-(3) (hospitals or cahs). 67. 42 c.f.r. § 495.6(d)(l)(i)-(15)(i) ( (1) use computerized provider order entry (cpoe) for medication orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guide­ lines. (2) implement drug-drug and drug-allergy interaction checks. (3) maintain an up-to-date problem list of current and active diagnoses. (4) generate and transmit permissible prescriptions electronically (erx). (5) maintain active medication list. (6) maintain active medication allergy list. (7) record all of the following demographics: (a) preferred language. (b) gender. (c) race. (d) ethnicity. (e) date of birth. (8) record and chart changes in the following vital signs: (a) height. (b) weight. (c) blood pressure. (d) calculate and display body mass index (bmi). (e) plot and display growth charts for children 2 20 years, including bmi. (9) record smoking status for patients 13 years old or older. (10) report ambulatory clinical quality measures to cms or, in the case of medicaid eps, the states. (11) implement one clinical decision support rules relevant to specialty or high clinical priority along with the ability to track compliance with 2011] reframing adoption of electronic health records 55 of cpoe for medication orders and the documentation of the smoking sta­ tus of patients thirteen years old or older.68 the menu set69 includes objec­ tives such as incorporating clinical lab-test results into the record as structured data70 and providing patients with timely electronic access to their health information. 71 since the final rule decreased the provider eligibility objectives by in­ troducing the core set/menu set distinction, providers now face considerably less burdensome (outcome) measures. take for example the core objective of using cpoes for medication orders.72 the proposed rule called for an eighty percent measure, 73 yet the final rule reduces the measure to "more than 30 percent of all unique patients with at least one medication in their medication list seen by the ep have at least one medication order entered that rule. (12) provide patients with an electronic copy of their health information (including diagnostics test results, problem list. medication lists, medica­ tion allergies) upon request. ( 13) provide clinical summaries for patients for each office visit ( 14) capability to exchange key clinical information (for example, prob­ lem list, medication list. allergies, and diagnostic test results), among providers of care and patient authorized entities electronically. (15) protect electronic health information created or maintained by the certified ehr technology through the implementation of appropriate technical capabilities.) 68. 42 c.f.r. § 495.6(dx9xi). 69. 42 c.f.r. § 495.6(exlxihloxi): ( 1) implement drug-formulary checks. (2) incorporate clinical lab-test results into ehr as structured data. (3) generate lists of patients by specific conditions to use for quality im­ provement, reduction of disparities, research, or outreach. (4) send reminders to patients per patient preference for preven­ tive/followup care. (5) provide patients with timely electronic access to their health infor­ mation (including lab results, problem list. medication lists, and aller­ gies) within 4 business days of the information being available to the ep. (6) use certified ehr technology to identify patient-specific education resources and provide those resources to the patient if appropriate. (7) the ep who receives a patient from another setting of care or provid­ er of care or believes an encounter is relevant should perform medication reconciliation. (8) the ep who transitions their patient to another setting of care or pro­ vider of care or refers their patient to another provider of care should provide summary care record for each transition of care or referral. (9) capability to submit electronic data to immunization registries or immunization information systems and actual submission according to applicable law and practice. (10) capability to submit electronic syndromic surveillance data to pub­ lic health agencies and actual submission according to applicable law and practice. 70. 42 c.f.r. § 495.6(e)(2xi). 71. 42 c.f.r. § 495.6(e)(5xi). 72. 42 c.f.r. § 495.6(dx1xi). 73. electronic health record incentive program. 75 fed. reg. 1,844 (proposed jan. 13, 2010) (to be codifiedat42 c.f.r. pts. 412,413,422, and495). 56 indiana health law review [vol. 8:43 using cpoe."74 similarly, thee-prescribing measure declined from seven­ ty-five percene5 to forty percent.76 exclusions apply when the objective is irrelevant or not cost-effective; for example, the same cpoe objective does not have to be complied with by an ep ''who writes fewer than 100 pre­ scriptions during the ehr reporting period."77 hospital eligibility is determined by almost identical sets of objec­ tives. some ep objectives are not carried over to reflect context or omis­ sion to reflect relevance. there are also some unique objectives such as the menu set objective to "[g]enerate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or out­ reach.'m in general, eps and hospitals demonstrate that they have complied with the meaningful use criteria through' a cms approved attestation pro­ cess. 79 later iterations of meaningful use likely will move that reporting to the ehr system itself. as already noted these objectives and measures apply only to the first two years (stage 1) of the program. two additional stages are anticipated, with stage 2 criteria to be published in late 2011 and stage 3 criteria to ap­ pear in late 2013.80 together stages 2 and 3 will demand more robust health information exchange (including orders and test results) and the abil­ ity of the data to better "follow" the patient.81 specifically, stage 2, begin­ ning in 2013, will expand stage 1 criteria to encompass care delivery standards in the areas of disease management, clinical decision support, medication management, patient access to their own health information, transitions in care, quality measurement and research, and bi-directional communication with public health agencies.82 finally, stage 3, beginning in 2015, likely will focus on decision support, self-management tools for patients, and improving population health outcomes. 83 cms is playing its cards closely as far as the ratcheting up of the ob74. 42 c.p.r.§ 495.6(d)(1xii). 75. electronic health record incentive program. 75 fed. reg. 1,844. 76. 42 c.p.r. § 495.6(d)(4xii). 77. 42 c.p.r.§ 495.6(d)(1)(iii). 78. 42 c.p.r.§ 495.6(g)(4xi). 79. 42 c.p.r. § 495.8; see also§ 495.210. 80. electronic health record incentive program, 75 fed. reg. 44,314 (july 28, 2010) (to be codified at 42 c.p.r. pts. 412,413,422, 495). 81. see emily long, officials defend meaningful use standards as a work in pro­ gress, nextgov (jul. 20, 2010), http://www.nextgov.com/nextgov/ng_20100720_9874. php?oref=topnews (reporting on congressional testimony from dr. blumenthal and cms's tony trenkle that stages 2 and 3 wiu have stricter requirements). 82. id. 83. electronic health record incentive program, 75 fed. reg. 1,844 (proposed jan. 13, 2010) (to be codified at 42 c.p.r. pts. 412,413,422, and 495); melinda beewkes buntin et al., health information technology: laying the infrastructure for national health re­ form, 29 health aff. 1214, 1219 (2010). see generally electronic health record incentive program, 75 fed. reg. at 44,321-22 (additional detail regarding stage 2 and 3). 2011] reframing adoption of electronic health records 57 jectives and measures in future iterations of the meaningful use regulations, stating that the criteria will be "consistent with anticipated developments in technology and providers' capabilities.''84 a notice of proposed rulemaking for stages 2 and 3 is expected in the fourth quarter of 2011 and will focus on infrastructure and interoperability.85 in the meantime and with regard to stage 1, the scaled back objectives and measures may result in the current meaningful use criteria· being more attuned to the actual use of ehr tech­ nologies by those physicians already using them. 86 in an interview pub­ lished after the publication of the proposed rule, dr. blumenthal explained what he calls the "escalator problem," we have to get providers on the escalator, get them moving up the escalator, keep them on the escalator toward more and more sophisticated and demanding uses of electronic technologies. we don't want them jumping off, we don't want them running back down in terror at what we've asked of them. but we also don't want the escalator to turn into one of those air­ port moving walkways where you end up after [a] long trip at precisely the same altitude as where you started.87 at the time of publication of the final rule dr. blumenthal noted how it "strikes a balance between acknowledging the urgency of adopting ehrs to improve our health care system and recognizing the challenges that adop­ tion will pose to health care providers. the regulation must be both ambi­ tious and achievable."88 the unanswered question is whether hhs found that correct balance or whether the less ambitious first stage will end up jeopardizing the ehr initiative's sustainability. b. certification as already explained, physician and hospital eligibility for the hitech subsidy program is dependent upon meaningful use of certified health records. as a result and accompanying cms' s meaningful use rule, onc has issued final rules setting out the standards for certification and 84. fact sheet: cms defines mu, supra_note 59. 85. diana manos, government planning for less 'rushed' next stages of meaningful use, healthcare it news, oct. 21, 2010, http://www.healthcareitnews.com/news/ gov­ ernment-planning-less-rushed-next-stages-meaningful-use. 86. see generally hogan & kissam, supra note 2, at 603. 87. david j. brailer, guiding the health information technology agenda, 29 health aff. 588, 589 (2010). 88. blumenthal & tavenner, supra note 6, at 504. 58 indiana health law review [vol. 8:43 certification processes for ehr products.89 in cms's words, "providers and patients must be confident that the electronic health information tech­ nology (health it) products and systems they use are secure, can maintain data confidentially, can work with other systems to share information, and can perform a set of well-defined functions. "90 while the meaningful use rule applies to providers who wish to bene­ fit from stimulus funding, the certification rule applies to the technology they will use.91 thus, this latter rule92 provides ehr vendors with the min­ imum specifications necessary to build and have certified an ehr system. 93 specifications include; the ability to record and chart vital signs,94 the maintenance of active medication lists,95 the maintenance of medication allergy lists,96 the ability to include laboratory test results,97 and the capabil­ ity to generate lists of patients with specific conditions.98 the rule applies to both ehrs and modular systems that satisfy one or more but not all crite­ ria.99 as an example of the required functionality of a certified ehr, con­ sider drug interactions. the relevant ep core set meaningful use objec­ tive is the implementation of drug-drug and drug-allergy interaction 89. see generally fact sheet: cms defines mu, supra note 59. 90. standards and certification, u.s. dep't. health and human services, http:/ /healthit.hhs.gov/portal/server.pt?open=512&objid= 1153&mode=2 (last updated oct. 6, 2010). 91. initial set of standards, implementation specifications, and certification criteria for electronic health record technology, 75 fed. reg. 44,590 (july 28, 2010) (to be codi­ fied 45 c.f.r. pt. 170). the purpose of this fmal rule, therefore, is to adopt standards, implemen­ tation specifications, and certification criteria to test and certify that a complete ehr or ehr module provides certain capabilities, and where applicable, to require that those capabilities be implemented in accord­ ance with adopted standards and implementation specifications. the adopted standards, implementation specifications, and certification crite­ ria were not intended to impose independent requirements on the entities using certified ehr technology. unlike certain other regulatory re­ quirements to which eligible professionals or eligible hospitals may be subject, it is not within the intended scope of this final rule to specify the requirements for entities using certified ehr technology. 92. 45 c.f.r. § 170 (2010). 93. see certification programs, u.s. dep't. health and human services, http://healthit.hhs.gov/portal/server.pt?open=512&objid=2884&parentname=communitypa ge&parentid=357&mode=2&in_hi_userid=12059&cached=true (last updated dec. 16, 2010); initial set of standards, implementation specifications, and certification criteria for electronic health record technology, 75 fed. reg. 33,590. 94. 45 c.f.r. § 170.302(f). 95. 45 c.f.r. § 170.302(d). 96. 45 c.f.r. § 170.302(e). 97. 45 c.f.r. § 170.302(h). 98. 45 c.f.r. § 170.302(i). 99. 45 c.f .r. § 170.300 (in which case to qualify the meaningful user would have to be using modules that together satisfy all the certification criteria). 2011] reframing adoption of electronic health records 59 checks, 100 while the measure is that "the ep has enabled this functionality for the entire ehr reporting period."101 the parallel certification criterion for drug-drug and drug-allergy interaction is: "[a]utomatically and electron­ ically generate and indicate in real-time, notifications at the point of care for drug-drug and drug-allergy contraindications based on medication list, med­ ication allergy list, and computerized provider order entry (cpoe)."102 ironically, given the error-reducing goal of ehr adoption, the certifi­ cation standard does not expressly address the issue of errors in ehrs themselves and their potential adverse effect on patient safety. 103 in febru­ ary 2009, a device regulator for the food and drug administration ("fda") updated the hit policy committee on a series of hit adverse events in­ cluding ehr data errors and misidentification of patients.104 although there was no formal reporting system the fda had recorded 260 "hit­ related malfunctions" in the preceding two years.105 potential regulatory responses range from post-market surveillance to full fda device pre­ market approval. 106 the committee, although accepting of a meaningful use stage 2 reporting or feedback function that would tag ehr errors, be­ lieved that fda regulation would inhibit innovation and increase costs. 107 there have been press reports that the fda and onc continue to be at odds as to the correct path to follow. 108 a single certification body, the certification commission for health information technology ("cchit")/09 had existed since the bush era (though, of course, with little work to do). however, onc was determined to have multiple bodies qualified to provide certification. in rnid-2010 onc introduced a temporary certification process that enabled providers 100. 42 c.f.r. § 495.6(d)(2)(i) (2010). 101. 42 c.f.r. § 495.6(d)(2)(ii). 102. 45 c.f.r. §170.302(a)(l). 103. see generally nicolas p. terry, when the "machine that goes 'ping"' causes harm: default torts rules and technologically-mediated health care injuries, 46 sr. louis u. l. j. 37, 37-59 (2002). 104. hit safoty, hearing before the certification/adoption workgroup of the office of the national coordinator for health information technology hit policy committee (feb. 25, 2010) (testimony of dr. jeffrey shuren, m.d., director of fda's ctr. for devices and radiological health), available at http://healthit.hhs.gov/portallserver.pt/gateway/ptargs _0_11673_910717 _0_0_18/3shuren_testimony022510.pdf. 105. id. 106. see generally overview of device regulations, food and drug admin., http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/default.htm (last updated aug. 31, 2009). 107. mary mosquera, hhs panel endorses patient safety database, gov't health it (april22, 2010), http://govhealthit.com/newsitem.aspx?nid=73573. 108. see, e.g., fred schultz & emma schwartz, fda, obama digital medical records team at odds over safety oversight, huffington post lnvestiga tive fund (aug. 3, 2010, 5:07 pm), http:/lhuffpostfund.orglstories/2010/08/fda-obama-digital-medical-records-team­ odds-over-safety-oversight. 109. certification comm'n for health info. tech., http://www.cchit.org/ (last vis­ ited dec. 30, 2010). 60 indiana health law review [vol. 8:43 and hospitals to implement the technology necessary to qualify for stage 1 meaningful use incentive payments during the first year of the program.110 the regulation provided for onc-authorized testing and certification bodies ("onc-atcb") 111 and detailed the process that testing agencies should take to become one of these certifying bodies. 112 that temporary process sun-sets in december 2011 and will be replaced by a permanent certification program. this latter also provides for post-certification surveil­ lance.113 on august 30, 2010, onc announced its first two onc-atcbs, cchit and the drummond group.114 on september 17, 2010, onc an­ nounced a third, lnfogard laboratories, inc.115 subsequent announcements have increased the number of atcbs to six.116 the onc web site now fea­ tures a searchable listing of all errs and ehr modules that have been tested and certified under the temporary certification program; the so­ called certified hit product list ("chpl").117 as one hhs consultant not­ ed, the new rule "really filled the gap for providers," and provides security for their ehr adoption since ''they'll have a product so they'll be able to get their incentive payments."118 the temporary program is due to expire at the end of 2011.119 subse­ quently, a permanent program will divide the responsibilities of testing and certifying ehr products between two organizations: the national institute of standards and technology would be responsible for testing the "compe110. establishment of the temporary certification program for health information technology, 75 fed. reg. 36,158 (jun. 24, 2010) (to be codified at 45 c.f.r. pt. 170); see also certification programs, supra note 93 111. press release, u.s. dep't ofhealth and human services, onc issues final rule to establish the temporary certification program health record technology (june 18, 2010), available at http://www.hhs.gov/news/press/2010pres/06/20100618d.html. 112. 45 c.f.r. § 170.401 (2010). 113. establishment of the permanent certification program for health information technology, 76 fed. reg. 5,1262 (jan. 7, 2011), http://origin.www.gpo.gov/fdsyslpkg!fr2011-0l-07/pdf/2010-33174.pdf. 114. frank irving, onc names cchit and drummond group as initial ehr certifica­ tion bodies, 1iie poutics of health care (sep. 1, 2010, 10:35 am), http:/ /community.advanceweb.comlblogs/ot _11/archive/201 0/09/01/onc-names-cchit-and­ drummond-group-as-initial-ehr-certification-bodies.aspx. 115. mary mosquera, onc names lnfogard as third ehr certifier, gov't health it (sep. 17, 2010), http://www.govhealthit.com/newsitem.aspx?nid=74676; see also infoguard laboratories approved to certify ehr, infoguard (sept. 20, 2010) http://www.infogard.com/ig.nsflhtmi/approved+onc-atcb+laboratory. 116. onc-authorized testing and certification bodies, onc, http://healthit.hhs.gov/portavserver.pt?open=512&mode=2&objid=3120 (last visited jan. 8, 2011). 117. certified health it product list, onc, http://onc-chpl.force.com/ehrcert/ chplhome (last visited jan. 8, 2011 ). 118. joseph conn, certification proclamation; hhs unveils process to help providers with it subsidies for ehrs, mod.iiealthcare, march 8, 2010, at 8. 119. establishment of the temporary certification program for health information technology, 75 fed. reg. 36,158, 36161, 36184 (jun. 24, 2010) (to be codified at 45 c.f.r. pt. 170). 2011] reframing adoption of electronic health records 61 tency" of the product for usability, while one of the onc-atcbs will pro­ vide the actual certification.120 in spite of a lingering concern that onc gave up too much of the pro­ posed rule's ground in the final meaningful use rule, examined together, the meaningful use and certification regulations are a noteworthy accom­ plishment, particularly given the collapsed timetable that hhs was forced to use. v. improving quality: a broader frame for meaningful use no doubt it was fortuitous that ehr, rather than some other public works project, was "shovel-ready" as the 2009 economic stimulus package was being constructed. the privatized governance models and market-led approaches to ehr adoption of the bush administration had failed to coun­ ter widespread market failure. however, the administration's structured cheerleading had moved some important conceptual and technical balls down the field. it was also key that from 2004 to 2009, the major political issue of public funding aside, ehr adoption work had found broad non­ partisan support within congress and among health care and hit industries. the tipping point was likely the existence of the 2005 and 2007 wired for health care quality act texts that could be reworked into the new hitech legislation within the arra timetable.121 there is no doubt that the initial and still primary goal of hitech is the stimulation of ehr adoption. in defraying some of the costs associated with implementing ehrs, we should see a reduction in the historical barri­ ers to ehr adoption especially among small physician office practices. 122 however, even as an economic stimulus during a time of financial cri­ sis, $27 billion is an enormous sum to pay out to economically successful private individuals and entities. further, this is third-party investment that potentially will bring considerable and measurable financial benefits to healthcare providers. for example, it has been estimated that if health care providers introduced "best-practice" it platforms they could see savings of $40 billion annually.123 as ehr penetration increases and meaningful use and related criteria expand to include analytical tools designed to test the quality outcomes associated with electronic records and other hit the true 120. id.; joseph goedert, proposed certification rule changes game: ehr testing, certification to be split, health data mgmt., april201 0, at 22. 121. wired for health care quality act 2005, s. 1418, 109th cong. (2005), available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=l09 _cong_bills&docid=f:s1418r th.txt.pdf; wired for health care quality act 2007, s. 1693, i loth cong. (2007), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname= 110 _ cong_ bills&docid=f:s 1693rs.txt.pdf. 122. hogan & kissam, supra note 2, at 601. 123. francois m. laflamme et al., reforming hospitals with it investment, mckinsey on bus. tech., summer2010, at27, 62 indiana health law review [vol. 8:43 quality picture should emerge. today, however, the picture lacks clarity with mixed messages as to the quality impact of ehrs and the suitability of existing metrics. 124 in 1991, and again in a 1997 revision, the institute of medicine had called for a nationwide implementation ofemrs.125 in 2001, in its canoni­ cal crossing the quality chasm, the institute declared, "it must pay a c.en­ tral role in the redesign of the health care system if a substantial improvement in health care quality is to be achieved during the coming decade. " 126 with such calls to action broadly ignored, it was no surprise that almost a decade later the hitech-funded hhs took a broad view of hit and how to incentivize its use. future headlines might refer to ehrs but the department's initiative is about hit niore generally, including cpoes, cdss systems, and the networks needed to bind them together. in 2009, dr. blumenthal had remarked that it would be ''tempting to measure hitech' s payoff .•. in narrow terms for example, the num­ bers of computers newly deployed in doctors • offices and hospital nursin~ stations."127 "that," he argued, "does not seem to be congress's intent."128 rather, "[i]t wants improvements in health and health care through the use of hit!'129 indeed, it is difficult to see the meaningful use proposed rule's ambitiously high bar for funding as anything other than a determina­ tion by hhs to play hardball with the stimulus funds, no doubt recognizing that it had been presented with a once in a generation opportunity to bring about major change. not surprisingly therefore, the inclusion in hitech of the elegant phrase "meaningful use" together with the emerging political reality of broader health care reform under the obama administration discloses a con­ siderably broadened agenda. as described by cms, ''ultimately, consistent with other provisions of law, meaningful use of certified ehr technology should result in health care that is patient-centered, evidence-based, preven­ tion-oriented, efficient, and equitable."130 once again, however, dr. blu­ menthal extracted the true value of meaningful use, "it is an incredibly powerful concept. it's a brilliant use oflanguage. it's simple but extremely meaningful ... !'131 indeed, the meaningful use structure transcends any 124. spencer s. jones et. al., electronic health record adoption and quality improve­ ment in us hospitals, 16(12 special issue) am. j. managed care sp64-sp71 (2010). 125. paul c. tang & w. ed hammond, a progress report on compjjter-based patient records in the united states, the computer-based patient record, 189 (richard s. dick et al. eds., revised ed. 1997). 126. instnutbofmed.,supranote9,at 165. 127. blumenthal, supra note 2, at 1477-78. 128. ld . 129. ld 130. electronic health record incentive program, 75 fed. reg. 1,844, 1,852 (proposed jan. 13, 2010) (to be codified at 42 c.f.r. pts. 412,413,422, and 495). 131. brailer, supra note 87, at 588. 2011] reframing adoption of electronic health records 63 expected accountability-for-stimulus-funds model. access to funding, however imperfect and incomplete, was accomplished with 2010's health care reform. at stake with the hitech billions is the new health care trini­ ty of"quality, efficiency, and patient safety."132 indeed, the key to understanding where hhs wishes to take hitech is to be found in yet another of dr. blumenthal's comments, "the passage of the patient protection and affordable care act of 2010[ppaca]133 marks a new era in american health care. yet in many ways, this era began more than a year earlier, with the passage of ... [hitech]."134 this reading places ehr subsidies, hitech, and meaningful use in a subtly different frame. recall that ppaca eschewed a public option let alone a single-payer model.135 for these, among many other reasons, it is arguable that the legislation fell short of fundamental health care reform.136 on the other hand, it did introduce quite fundamental health care financing and insurance reforms. hhs likely believes that hitech provisions can be leveraged both to operationalize some ppaca goals and to tease out some structural reforms not directly provided for by the broader health care reform legislation. dr. blumenthal and his hhs colleagues have promoted the synergy between their hit work and ppaca' s goals of improving quality, 137 reducing costs, 138 and accelerating outcomes research.139 this is ambition on a different scale from a national roll out of ehrs. if there is an hit trojan horse at work here, it is likely to disgorge its forces in the cause of health quality. the "meaningful use" matrix will lead to changes in established health care workflows and imagines the fu­ ture ofhealth care as one based on outcomes and effectiveness research and on evidence-based medicine.140 as noted in a recent bipartisan policy cen­ ter report, hit has the potential to facilitate many types of im­ provements in health care delivery, including reduc132. see fact sheet: cms proposes, supra note 41. 133. patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (march 23, 2010) amended by health care and education reconciliation act of2010, pub. l. no. 111-152, 124 stat. 1029 (march 30, 2010) (to be codified at various sections of 42 u.s.c.). 134. buntin et at., supra note 83, at 1214. 135. not coincidentally ihtech also eschews a "public option" such as the federal government building a national ehr. see generally margarit gur-arie, the government ehr, on healrn care tech. blog (aug. 22, 2010, 10:34 pm), http:l/onhealthtech.blogspot.com/2010108/govemment-ehr.html. 136. see, e.g., paul krugman, why the public option matters, the conscience of a liberal, (sept. 8, 2009, 4:56 pm), http:/lkrugman.blogs.nytimes.com/2009/09/08/why-the­ public-option-matters/. 137. buntin et at., supra note 83, at 1215-16. 138. ld. at 1216-17. 139. id. at 1217-18. 140. see goedert, supra note 52. at 40. 64 indiana health law review ing medical errors; improving access to timely infor­ mation, thereby enabling patients to become more ac­ tively engaged in and responsible for their own care; reducing paperwork and other administrative costs; and collecting and disseminating quality met­ rics that can improve the evidence base for medical decisions.141 [vol. 8:43 ppaca itself includes several outcomes initiatives.142 potentially the most important is the establishment and funding of the nonprofit patient­ centered outcomes research institute ("pcorr').143 hhs-led hit will be a crucial factor in collecting and disseminating such research.144 regarding publicly-funded care ppaca also mandated an hhs plan for modernizing cms computer and data systems with particular focus on outcomes.145 the extent to which hitech-funded hit will reduce costs is more of an open question. ppaca itself makes only modest attempts to bend the cost curve.146 indeed, some analysts argue that the cost curve has bent in the wrong direction.147 notwithstanding, ppaca calls for a voluntary gain­ sharing program called medicare shared savings,148 a pilot program on medicare payment bundling, 149 and the "hospital readmissions reduction program" that will decrease hospital medicare payments for preventable readmissions.150 the most that can be said is that a patient record focused 141. mckethan et al., supra note 9, at 19. 142. see generally stacey mcmorrow, robert wood johnson foundation/urban institute, will the patient protection and affordable care act of 2010 improve health outcomes for individuals and families? (2010), available at http://www.urban .org/uploadedpdf/412127-2010-health-outcome.pdf. 143. 42 u.s.c.a. § 1320e(b) (west 2010). see generally editorial, is newer better? not always, n.y. times, sept. 11, 2010, at wk10, available at http://www.nytimes.com/ 2010/09/12/opinion/12sunl.html. see also peter j. neumann & milton c. weinstein, legislating against use of cost-effectiveness information, 363(16) new eng. j. med. 1495 at 1495 (2010), available at http://www.nejm.org/doilpdf710.1056/nejmpl007168. 144. see, e.g., 42 u.s.c.a. § 1320e(c)-(d). 145. 42 u.s.c.a. § 10330 (2010). cms has responded with a detailed plan that promis­ es quality improvements. see, modernizing cms computer and data systems to support improvements in care delivery, cms (dec. 23 2010), http://www.cms.govllnfotechgen info/downloads/cmssection10330plan.pdf. 146. implicit attempts at improving the cost picture primarily are a bet on preventative care. see, e.g., howard k. koh & kathleen g. sebelius. promoting prevention through the affordable care act, 363 new eng. j. med. 1296 (2010). 147. leanne s. ringel et al., rand corp., rb-9514, poucy brief: analysis of the patient protection and affordable care act (h.r. 3590) (2010), available at ,http://www.rand.org/pubs/research_briefs/2010/rand_rb9514.pdf (estimating a 2% in­ crease in national health care spending between 2014 and 2019). cf. peter r. orszag & ezekiel j. emanuel, health care reform and cost control, 363 new eng. j. med. 601, 603 (2010). 148. 42 u.s.c.a. § 1395jjj (west2010). 149. 42 u.s.c.a. § 1395cc-4. 150. 42 u.s.c.a. § 1395ww(q). see generally orszag & emanuel, supra note 147 2011] reframing adoption of electronic health records 65 hit system will support such programs. there are some estimates of sav­ ings that will flow directly from system-wide implementation of primary care ehrs: $85,000 per provider or some $70 billion.151 more important are the quality and cost reduction programs that are not yet legislated but likely will be necessary going forward as fortin and zywiak note, "pay­ ment for health care in the united states is on the cusp of a rapid shift from payment based on volume and intensity of service to a model that ties pay­ ment to high-quality and tightly coordinated care."152 an additional area where hitech and ppaca intersect is in the lat­ ter's requirements of transparency and patient empowerment. for example, the hospital value-based purchasing program requires web-based infor­ mation for stakeholders including patients, 153 while the health reform legis­ lation requires hhs to open a web portal ''through which a resident of any . . . state may identify affordable health insurance coverage options in that state. "154 hhs has issued interim regulations regarding its new web por­ tal155 and already has opened its one-stop-shop for healthcare website.156 related initiatives such as the patient bill of rights that is being constructed out of the insurance reforms (for example, the prohibition of preexisting condition exclusions)/57 the new office of consumer information and in­ surance oversight, 158 can all leverage improved hit. although there may be some exaggeration of the role of hitech in facilitating more general health care reform, there is truth in dr blumen­ thal's message that "[a]lthough hitech may be viewed narrowly as legis­ lation to stimulate the adoption of health information technology . . . it is better understood as an essential foundation for our broader efforts to re­ structure health care delivery."159 (detailing the cost-control elements of aca and calling for a reduction in health care cost inflation). 151. mckethan et al., supra note 9, at 20. 152. fortin & zywiak, supra note 32, at 54. see also steve lobr, the agenda behind electronic health records, bits, (may 9, 2010, 6:29 pm), http://bits.blogs.nytimes.com/ 20 i 0/05/09/the-agenda-behind-electronic-health-records/ ("the electronic health record, in dr. blumenthal's view, is a tooland yes, a stalking horsefor bringing measurement, . data-based decision-making and accountability to the practice of medicine. the computerized patient record, then, is a step toward changing compensation of medicine and the economics of health care."). 153. 42 u.s.c.a § 1395ww(bx3)(bxxxi). 154. 42 u.s.c.a. § 18003(a) (west 2010) .. 155. 45 c.f.r. § 159 (2010). 156. healthcare.gov, http://www.healthcare.gov/ oast visited dec. 30, 2010). 157. see, e.g., 45 c.f.r. §§ 144, 146-47 (2010). see generally fact sheet: the affordable care act's new patient's bill of rights. healthr.eform.gov (june 22, 2010), http://www.healthreform.gov/newsroom/new _patients_ bill_ of_ rights.btml. 158. the office of consumer information and insurance oversight, u.s. dep't health and human services, http://www.hhs.gov/ociio/index.html oast visited dec. 30, 201 0). 159. buntin et al., supra note 83, at 1214. 66 indiana health law review [vol. 8:43 vi. conclusion the obama administration has recently "re-branded" the patient pro­ tection and affordable care act (''ppaca") as the pithier affordable care act ("aca").160 bill sage has argued that even this truncated version is uninspiring and lacks "expressive value," preferring a title such as "ameri­ care."161 as a title, the health information technology for economic and clinical health act is already a better descriptor than what could have been; say "an act to subsidize health records." whatever its name the stimulus-funded ehr program is indeed a "transformational opportunity."162 of course, what is unknown is whether the stimulus program will produce dramatic or, for that matter, even rela­ tively modest gains in ehr penetration. some of the barriers are notable. thirty to forty percent of hospitals were unlikely to meet qualifying re­ quirements for stage 1 incentives under the proposed rule. 163 the final rule will increase that number, but it is unknown by how much.164 the barrier to funding is not simply financial; cultures must be challenged, personnel hired, ehr and hit strategic plans must be developed.165 longer term, the extent of the shortfall between the stimulus funds and the tco of the rec­ ords and related technologies must be managed by eps and hospitals.166 budgets will have to be developed to support the purchase of the next gen­ erations of hit that are bound to follow. even with the incentive payments defraying initial costs, the invest­ ment by providers and hospitals remain considerable. to meet the mean­ ingful use standards, hospitals and providers with existing errs will have a specific need for technological support that can effectively integrate the new "certified" ehr systems with existing systems to meet meaningful use167 a particular challenge for those with home-grown it systems. while the incentive is generous, the upfront cost of implementation and continuing maintenance likely will remain problematic for hospital and 160. the affordable care act, widtehouse.gov, http://www.whitehouse.gov/health reformlhealthcare-overview (last visited dec. 30, 201 0). 161. william m. sage, why the affordable care act needs a better name: 'amen­ care', 29 healthaff. 1496, 1496 (2010). 162. blumenthal & tavenner, supra note 6, at 501. 163. joseph conn, hospital emr reimbursements at risk: himss, modernhealthcare.com (may 21, 2010, 12:45 pm), http://www.modernhealthcare.com/ apps/pbcs.dll!article? ald=/20 i 00521/news/ 100529983. 164. see e.g., pear, supra note 51 (stating that the president of the american hospital association said the final rules were an improvement over the original proposal, but that he was concerned that many hospitals would be unable to obtain federal aid). 165. see generally kimberley klein, so much to do, so little time, j. healthcare info. mgmt., winter 2010, at 31. 166. see generally catherine arnst, doctors not in stampede to go digital, bos. globe, may 4, 2010, at l. 167. desroches & rosenbaum, supra note 44, at 1153. 2011] reframing adoption of electronic health records 67 physician providers. for example, it has been estimated that "us hospitals will need to spend approximately $120 billion" while the arra subsidies will "offset only approximately 15 to 20 per cent of total expenditures .... a spending gap of about $60,000 to $80,000 a bed. " 168 between one-third to two-thirds of health information system imple­ mentations fail. 169 this begs another difficult question: what happens in 2016 and beyond-will the ehr project be sustainable after funding ceas­ es?170 can cultures and investment strategies be changed in such a short timeframe? after all, more limited summary records systems in australia and the uk171 have either failed or suffered massive cost overruns. 172 and, in the us the only two successful implementations of comprehensive ehrs have been through the veterans administration ("va") 173 and within kai­ ser permanente;174 institutions that are fully vertically integrated, de facto single-payer systems, and so quite unlike most of the u.s. health care sys­ tem. at its most literal level "meaningful use" is an appropriate (and fasci­ nating) outcome measure for the investment in hit provided by the federal stimulus package. the far more significant level is the tying together of hit, health quality outcomes, and health care financing. if that process seeps into the culture then hitech's mixture of plenty of carrots and a few 168. laflamme et al., supra note 123, at 28. 169. klein, supra note 165, at 32. 170. the success of the project will also depend on changes in the supply side. current­ ly there are 300 to 400 ehr providers in the united states. see olen, supra note 16. effi­ ciencies and cost reductions likely will depend on new technology models such as low(er) cost web services technologies or through consolidation around dominant, large scale suppli­ ers. see e.g., steve lohr, l.b.m. 's strategy in electronic health records, bits (aug. 5, 2010, 11 :00 am), http://bits.blogs.nytimes.com/201 0/08/05/i-b-m-s-strategy-in-electronic­ health-records/?ref=technology (describing ibm's linkage with activehealth management, a subsidiary of health insurer ae1na); hp health: ehreadysm program, hewlett packard, http://h71 036. www7 .hp.com/enterpriselus/ehready-program.html (last visited dec. 30, 2010); healthcare it solutions, general electric (ge) healthcare, https://www2.gehealthcare.com/portal/site!usen/menuitem.f76842a5b061 0 162d6354al 074c8 4130/?vgnextoid=cc8da52fcea2d110vgnvcm100000258c1403rcrd (last visited dec. 30, 2010); nextgen healthcare, http://www.nextgen.com/ (last visited dec. 30, 2010); allscripts, http://www.allscripts.com/ (last visited dec. 30, 2010). there is already a measurable increase in the priority of ehr implementation among hit professionals. see embarcadero technologies, tech note: healthcare data management survey report 3 (2010), available at http://www.embarcadero.com/images/dmlhealthcare-it­ survey-report-20 1 o.pdf. 171. summary care record (scr), nhs connecting for health, http://www.connectingforhealth.nhs.uk/systemsandservices/scr (last visited dec. 30, 2010). 172. nicolas p. terry & leslie p. francis, ensuring the privacy and confidentiality of electronic health records, 2007 u.ill. l. rev., 681,688-90 (2007). 173. see generally david brown. va takes the lead in paperless care, wash. post, apr. 10,2007, at heol. 174. see e.g., press release, kaiser permanente, kaiser permanente honored for elec­ tronic health record implementation (mar. 2, 2010), available at http://xnet.kp.org/news center/pressreleases/nat/20 i 0/03021 ostage7 .html. 68 indiana health law review [vol. 8:43 sticks will have paid astounding dividends. alas, we are unlikely to learn for several years whether hitech and its meaningful use touchstone will have transcended the status of a ''public works project,"175 (albeit a massive one) and transformed our health care system. meaningful use creates a powerful linkage to general health care reform. however, there is one con­ nection that no one wants to see: the failure of both hitech and ppaca to spur outcomes that neither health care nor hit markets have achieved in the past. 175. kleinke, supra note 20, at 1257. sallie thieme sanford sallie thieme sanford is an assistant professor at the university of wash­ ington school of law, with an adjunct appointment in the university of washington school of public health. she received her b.a. with honors from brown university and her j.d., order of the coif, from the university of california at los angeles. she began her legal career as a law clerk for the honorable robert r bee­ zer of the united states court of appeals for the ninth circuit. she then served as an assistant attorney general representing the university of washington medical center, harborview medical center and the uw's health sciences schools and research centers. professor sanford has been active on the board of the washington state society of healthcare attor­ neys and recently served as its president. professor sanford's research in­ terests focus on health care delivery systems, health administration law, medicare and medicaid, comparative health law, and medical and adminis­ trative ethics. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i teaching health law in rural ethiopia: using a pepf ar partnership framework and india's shanbaug decision to shape a course sallie thieme sanford• i. introduction ............................................................................... 487 n. haramava university ............................................................... 488 lll. overview of the courses .......................................................... 490 n. shanbaug and medical decision-making ............................... 492 v. pepf ar par1nership frameworks and population health .......................................................................................... 495 vi. some practical observations ................................................. 499 vll. conclusion .................................................................................. 501 i. introduction in april 2011, i taught a month-long intensive health law course at haramaya university college of law in rural eastern ethiopia. given the burgeoning interest in global health law, i suspect, and hope, that others are considering teaching similar courses, whether as visiting or resident faculty. this essay attempts to ease their course preparation workload. i will de­ scribe how i used two recent documents-india's 2011 shanbaug decision1 and ethiopia's 2010 pepfar partnership framewor~-to shape the course. both of these are worth consideration for use in a variety of health law and policy courses based in low-income countries with rapidly expand­ ing health systems. some aspects of my experience might also be helpful for other foreign teachers. the shanbaug case offers a useful introduction to various issues of law and ethics in individualized medical decision-making. it involves the publicly prominent case of an indian woman who has for nearly four dec­ ades met "most of the criteria for being in a permanent vegetative state.'.l • assistant professor of law, adjunct assistant professor of health services, university of washington. i am grateful to joan altman, jd, mph, for her fine research assistance, to christopher sanford, md, mph, for his invaluable insights, and to my colleagues at ha­ ramaya university and the university of washington for their helpful comments. and, of course, to richard wentzell, jd, ph.d., for facilitating this great teaching and learning expe­ rience. 1. shanbaug v. union of india, writ petition (criminal) 115 (2009) (india mar. 7, 2011 ), available at http://judis.nic.inlsupremecourtlchejudis.asp. 2. five-year partnership framework in support of the ethiopian national response to hiv/aids 2010-2014, u.s.-eth., oct. 27, 2010, available at http://www.pepfar.gov /documents/organization/154198.pd([hereinafter "ethiopia pf'1· 3. shanbaug, slip op. at 14. 488 indiana health law review [vol. 9:2 in legalizing and setting forth procedural guidelines for what it termed "passive euthanasia," 4 the supreme court of india surveys medical deci­ sion-making law from a number of jurisdictions and explicitly considers its applicability to india's legal and cultural contexts. as of january 2012, nineteen countries and two regions have entered into pepf ar partnership frameworks. 5 these documents propose a varie­ ty of country or region-specific health policy reforms. studying these proposals could focus discussion on the law's potential role in promoting population health in a given country. in addition, depending on the school's location and the issues of academic interest, a partnership frame­ work could provide an opportunity for timely problem-based learning in conjunction with affiliated health sciences faculty, policymakers, or local advocacy groups. i found that these documents helped shape an engaged class, and hope that others might take them far beyond what i did. my use of them in a short seminar at haramaya university can be considered a beta test. i also mention here some other resources that helped me prepare for this law class and also for school ofnursing classes i taught during the same visit. final­ ly, i offer some of the lessons i learned as a first-time foreign teacher not accustomed to a campus with hyenas. 11: haramaya university with a population of more than 80 million, ethiopia is the second most populous country in sub-saharan africa. it is a low-income country with a real per capita income of $232 united states dollars a year and near­ ly 40% of the population living below the international poverty line of $1.25 a day. it is also one of the least urbanized countries, with more than 80% of the population living in rural areas.6 although ethiopia has made gains in a number of health-related indicators in recent years, its health sta­ tus and system indicators remain low. life exrectancy is 53 years, and the infant mortality rate is 77 per 1,000 live births. haramaya university, formerly known as alemaya university, is one 4. id at41-45. 5. for a current list and links, see partnership frameworks, u.s. president's emergency plan for aids relief, http://www.pepfar.gov/frarneworks/index.htm (last visited june 4, 2012). 6. ethiopia pf, supra note 2, at 6. 7. !d. at 6-8. by comparison, in 2010 the united states life expectancy was 78.7 years of age and the infant mortality was 6.14 per 1,000 live births. see sherry l. murphy et al., deaths: preliminary data for 2010, 60 nat'l vital stats. reps., jan. 2012, at 6, 9, available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_04.pdf. a nice interactive website for comparative health status and systems comparisons is available at which coun­ tries are faced with a 'critical' health worker shortage?, guardian, jan. 17, 2011, http:l/www.guardian.eo.uk/global-health-workers!interactive/infographic-mortatlity-rates­ health-workers-uk-us-worlld. 2012] teaching health law in rural ethiopia 489 of ethiopia's oldest, having been founded in 1954 as an agricultural college on the shores of the now extinct lake haramaya. 8 the 1 ,500-acre main campus is located in ethiopia's oromia region, the least populated area of the country. in addition to the academic buildings, sports facilities, housing and cafes for the approximately 17,000 resident students, faculty, and staff, the spacious campus features crop fields, greenhouses, poultry barns, and livestock, ·including camels.9 the university has expanded significantly over the years to include, among its many programs, colleges of law, nurs­ ing, medicine, and public health. the college of law ("hu law"), founded in 2002, offers a five-year llb program and will graduate approximately 140 students in 2012. ethio­ pia is a civil law country, with some elements of common law based on precedent, as well as interaction with customary and shaiia law.10 in 2012 the law school plans to publish its first law review and begin an llm pro­ gram. its current dean is university of washington law school ("uw law") graduate richard wentzell, jd, ph.d. hu law and uw law now have a number of other academic alliances, furthered by a memorandum of understanding signed in 2011.11 for example, the two schools are collabo­ rating on a land tenure institute to help develop and improve rural land law and policy, and have exchanged students and faculty. 12 haramaya university's rapidly expanding colleges of medical and health sciences are located 15 kilometers away in harar, just outside the walls of this ancient islamic city. the health sciences college was found­ ed in 1996, and now includes schools of nursing and midwifery, public health, environmental health and laboratory technology.13 the medical sciences college, which will graduate its first class in 2013, recently as­ sumed management of the nearby 200-bed hiwot fana hospital and its as­ sociated clinics.14 the medical school class to graduate in 2013 includes 60 8. see welcome to haramaya university, liaramaya univ., http://www.haramaya. edu.et/ (last visited jan. 12, 2012). for a fuller wlderstanding of the university's history and roles, i am grateful to president belay kassa, ph.d., and to the recently opened on-campus museum devoted to haramaya's history. 9. in all of is programs, including distance and summer learning, approximately 31,000 students were enrolled in 2011. id 10. the globalex website is one helpful resource for summary information on the legal systems of a number of coldltries. tools for building foreign, comparative and inter­ national law collections, globalex, http://www.nyulawglobal.org/giobalexl (last visited may 18, 2012). 11. see 64 uw l. alumni mag. 37-40 (fall 2011), available at http://issuu.com/ uwschoolotlaw/docs/uwlaw _magazine_fall2011 ?mode=window&pagenumber=38. 12. id see also catherine o'donnell, law students from ethiopia learn as part of nation building, uw today (dec. 2, 2011 ), http://www. washington.edu/news/articles/law­ students-ftom-ethiopia-learn-as-part-of-nation-building. 13. thanks to health sciences college dean biftu geda and nursing and midwifery school head dereje meaza for their helpful introduction to these programs. and gracious assistance throughout the visit 14. college of medical sciences dean takaba abdosh, md, provided a personal tour 490 indiana health law review [vol. 9:2 students; the class of2017 has 220. 15 the nursing school has seen a similar rapid expansion across its programs.16 hu's harar bulletin of health sci­ ences published its inaugural issue in 2011, with an edition focusing on hiv i aids research.17 after participating in a hu law conference in 2010, i was invited to return and teach a course or courses for law and health sciences students. my husband, christopher sanford, md, mph, was also invited to interact with the medical school and hospita1.18 our sons nate and henry, then twelve and ten, came as well, and attended the l~al public school.19 lll. overview of the courses ultimately, i ended up teaching separate courses on the two haramaya campuses in april 2011.20 the ''seminar in current health law issues" included eighty-three upper-level law students, met twice a week, and re­ quired two papers and two quizzes. it was intended to provide an overview of current legal issues involving individual medical decision-making and also of the role of the law in promoting population health. i shaped this course around ethiopia's partnership framework and india's shanbaug de­ cision, both ofwhich are discussed below. in the nursing school, i taught an "ethical issues in health care'' module to eighty first-year nursing stu­ dents and facilitated classes with upper-level nursing students. these ses­ sions coalesced around small group discussions of hypotheticals i drafted based on ·medical literature,21 a nursing textbook, 22 and discussions with of the hospital and research offices, as weu as useful information about the program. 15. email from health sciences college dean biftu geda, jan. 15, 2012, on file with author. 16. /d. 17. liarar bull. health sci., http://www.haramaya.edu.et/index.php?option=com_ conten~view=article&id=427&1temid=211 (last visited june 10, 2012). 18. chris has a relevant background, being a family practice doctor with a specialty in travel and tropical medicine as weu as appointments at the university of washington school of medicine and department of global health. he also is one of the founders of the east africa diploma course in tropical medicine. this 12-week program. which had its first full session in 2011, is based in tanzania and uganda. a number of the student slots are re­ served for african physicians, who pay a lower tuition than the other students. see about, e. afr. diploma course in tropical med., http://www.tropmedafrica.org/ (last visited june 2, 2012). 19. the model school is located on campus and encompasses grades kindergarten through twelfth grade. the principal, basha haile, teachers, and students were very accom­ modating and helpful, with english teacher solomon beshahwred facilitating arrangements. our boys joined the seventh grade, the year in which most instruction begins to be in english rather than in ambaraic or oromo. 20. in may 2011, uw law professor patricia kuszler, jd, md, taught the same group of law students a follow-on course focusing on quality regulation in health care and interna­ tional medical research standards. she also taught similar material to nursing students. 21. a good source for links to this type of medical and bioethics literature is ethnomed, www.ethnomed.org (last visited june 6, 2012). this university of washington website contains medical and cultural information about immigrant and refugee groups. 22. sally huband et al., nursing and midwifery: a practical approach (2006). 2012] teaching heal til law in rural ethiopia 491 faculty. throughout the law school class, i frequently referred back to an exer­ cise from the first day. after a brief introductory lecture, i had the students break into small groups to discuss and prepare written responses to two questions without doing any outside research. i told them that the group members did not need to all agree on their responses. first: regarding health care or health care law, what does ethiopia or the oromia region do well? second: what aspect of health care in ethiopia would benefit from more or different regulation? in response to the question as to what ethiopia or the oromia region does well, many of the groups listed the use of health extension workers. ethiopia has been recognized for extensive and effective use of health ex­ tension workers, generally women from the community who receive a year's training in basic primary health care needs.23 other common re­ sponses included: mainstreaming hiv i aids treatment; constitutional recognition of a right to live in a healthy environment; expanded vaccina­ tion services; abortion laws; and improved maternal care. in response to the question as to what aspect of health care would ben­ efit from more or different regulation, the most common response was bet­ ter regulation of the quality of health care providers, including traditional medicine practitioners. use of traditional treatments is common in ethio­ pia, particularly in rural areas, and sometimes raises concern about safety and efficacy?4 other common responses included: greater access to pri­ mary care; prohibition on harmful practices such as female genital cutting; stricter abortion laws;25 more rural health care facilities; and effective regu­ lation of environmental impacts on health. on their written responses to these questions, i asked the students to write the names of each member of the group that developed them. where the responses tied into the topic of a subsequent class session, i was then able to ask specific students to elaborate. this technique seemed to encour­ age students to speak up (and also to help me better pronounce ethiopian names). a similar exercise with the nursing students worked much less well. with the nursing students, i did this as an individual, not group exer­ cise; and i made the mistake of telling them in advance that i would not be this textbook is specifically designed for use in low-income countries. 23. see, e.g .• wairagala wakabi, extension workers drive ethiopia's primary health care, 312 lancet 880 (2008). the head of the u.s. and u.k. governments' aid programs have recognized the ethiopian health extension program as offering potentially "game changing" lessons in the fight against international poverty. see press release, embassy of the united states: addis ababa. ethiopia. international development leaders hail ethiopian health extension program (sept. 21, 2011), available at http:l/ethiopia.usembassy.gov/pr2011/international-development-leaders-hail-ethiopian-health-extension-program-september21-2012.html. 24. see, e.g., richard m. hodes. cross-cultural medicine and diverse health beliefs: ethiopians abroad, 166 w. j. med. 29,29 (1997). 25. the prominence of "abortion laws" as a response to both questions probably was related to an on-campus debate on the topic that was scheduled for the following week. 492 indiana health law review [vol. 9:2 grading their responses. most of the law students, i later learned, had as­ sumed that this was a graded assignment. n. shanbaug and medical decision-making one challenge in teaching about legal issues arising in the context of medical decision-making is that many of the prominent cases and statutes have arisen in regions with extensive medical resources and a significant cultural focus on individual autonomy?6 how relevant is that body of law in regions with limited medical resources? how applicable is it to regions with a broader focus on family or group affiliations? as health systems expand to provide a higher level of care to more people, many questions are likely to gain prominence: to what information are patients entitled?; if a patient lacks decisional capacity, who should decide?; when may medical care be withheld or withdrawn?; is physician-hastened death ever appropri­ ate?27 any legal resolution of these questions is sure to be influenced by the cultural and medical context in which they arise. fortuitously, a few weeks before my haramaya law class began, in­ dia's supreme court handed down its decision in the publicly prominent end-of-life case involving arona shanbaug.28 the court begins its opinion with the statement: "we feel like a ship in an uncharted sea, seeking some guidance by the light thrown by legislations and judicial pronouncements of foreign countries[.]"29 this 110-page opinion includes a survey of cases and statutes from several jurisdictions on patients' rights of self­ determination, surrogate decision-making, withdrawal of care, physician­ assisted death, and active euthanasia. it explicitly considers their applica­ bility in india's cultural and legal context. the shanbaug case includes a compelling factual background. in 1973, while working as a nurse at king edward memorial hospital (kem) in mumbai, ms. shanbaug was brutally assaulted and strangled with a metal dog leash by "a sweeper" whom she had chastised for stealing food intend­ ed for the stray dogs utilized in the hospital's dog lab.30 ms. shanbaug sus26. see robert h. blank, end-of-life decision making across cultures, 39 j.l. med. & ennes 201 (20 11) (discussing limitations of the current focus on "western practices and values" and summarizing findings of a study of end-of-life policies in twelve countries, in­ cluding kenya and india). 27. see, e.g., id. at 211 (discussing the "surge in requests for assisted suicide because of the aids epidemic" in kenya). 28. in january 2012, a number of news reports from india were still available on-line. see, e.g., aruna shanbaug case: supreme court rejects euthanasia plea, ndtv, http://www .ndtv .com/article/india/aruna-shanbaug-case-supreme-court-rejects-euthanasia­ plea-89894 (last updated mar. 7, 2011) (reporting decision and showing nurses' reaction in streets around the hospital where ms. shanbaug resides). 29. shanbaug v. union of india, writ petition (criminal) 115 (2009), slip op. at 2 (in­ dia mar. 7, 2011), available at http://judis.nic.inlsupremecourtlchejudis.asp. 30. ld. at 2-3. 2012] teaching health law in rural ethiopia 493 tained severe brain damage. she has been largely unresponsive and almost completely paralyzed for nearly forty years, occupying the same bed all the while at kem hospital. based on testimony from a team of three court· appointed doctors, the court concluded that she meets the key criteria for being in a persistent vegetative state.31 the kem staff is described in the opinion as devoted to her care. all the student nurses are introduced to her and told that "she was one ofus."32 the independent physicians' report cites as evidence of exceptional nursing care the fact that in thirty.eight years ms. shanbaug has not had even a sin· gle bed sore.33 she is painstakingly spoon·fed mashed food, though in 2010, while she recovered from malaria, a naso.gastric tube was also used.34 pinky virani, a right·to.die activist who wrote a book about shan· baug's situation, petitioned for an end to the feedings, arguing that ms. shanbaug is ''virtually a dead person" and that not letting her "die peaceful­ ly" is causing her unnecessary pain and violating her right to dignity.35 ms. shanbaug' s family has not been involved in decades and declined to partic­ ipate in the case. 36 kem strongly objected, arguing that its staff is effec­ tively her family, and they want to keep caring for her. 37 in resolving the case, the court looked not only to indian law, but al­ so to that of other jurisdictions, predominantly in high-resource countries.38 for example, it considers the scope of patients' rights to consent to medical care and to refuse care, referencing, as do so many u.s. cases, sch/oendorff v. society of new york hospita/.39 the court goes on to consider the gen­ eral role of surrogate decision·makers where the patient lacks decisional capacity.40 it contrasts the "substituted judgment" standard favored in the · united states, with the "best interests of the patient" standard favored in other countries.41 much of the decision concerns the legal and ethical dis­ tinction between "active euthanasia," or physician-hastened death, and ''passive euthanasia," or a withdrawal of life·sustaining care; india's stat31. id. at 4. citing conflicting evidence, the supreme court appointed a panel of three independent physicians to examine ms. shanbaug and file a written report. the court then requested that the physicians provide a clarifying report explaining the first in non-medical terminology and also appear before them to answer questions and to screen a current dvd ofms. shanbaug. id at5, 17. 32. id. at9. 33. ld. at 8, 27. 34. /d.at10-11. 35. id. at 3-4. 36. !d. at 24. 37. id. at25-29. 38. see generally id for helpful background to india's law in this regard, see sushila rao, india and euthanasia: the poignant case of aruna slumbaug, 19 med. l. rev. 646 (2011). 39. slumbaug, slip op. at 66,81 (citing schloendorffv. society ofnew york hospital, 211 n.y. 125 (1914)). 40. /d. at 24, 36-37. 41. ld. 494 indiana health law review (vol. 9:2 utes and constitution are parsed and contrasted with "death with dignity" legal· frameworks in the netherlands, washington state and elsewhere. 42 pending enactment of a law by india's parliament, the court's opinion in shanbaug allows "passive euthanasia" (withdrawal of medical care) from an incompetent patient in certain circumstances. those circumstances in­ clude the irreversible nature of the patient's vegetative condition, and the court petition by an appropriate surrogate (typically close family, but possi .. bly a friend or physician) stating that continued treatment is not in the pa­ tient's best interest.43 the shanbaug court further requires review by independent medical experts and judicial approval. these procedural safe­ guards are "necessary in our country as we cannot rule out the possibility of mischief being done by relatives or others for inheriting the property of the patient.'744 the court goes on to reference george bernard shaw's play "the doctor's dilemma" and robin cook's novel coma45 in expressing its concern that a surrogate's decision to withdraw care might be impacted by india's substantial income variation, as well as ''the low ethical levels pre­ vailing in our society today and the rampant commercialization and corrup­ tion" that includes unscrupulous physicians.46 in the case at hand, the court concluded, the appropriate surrogate is kem, and its staff wishes to continue providing curative care (in the case of a malaria bout for example) and regular care (the feedings). thus it denied the petition. 47 i assigned an edited version of the shanbaug decision as the first as­ signment in my haramaya current issues in health law seminar. for the next several sessions, it became a touchstone for our discussions about pa­ tients' rights, the role of surrogates, and end..of-life decision-making. in one exercise, the students considered which of ethiopia's civil and criminal codes would have any relevance to the case. they discussed the tension between legal standards supporting a patient's right to make informed med­ ical decisions and cultural values that disfavor direct sharing of bad medical news. in another exercise, the students reviewed general bioethics principles· and discussed how they were expressed by india's supreme court. one in­ teresting discussion centered on the role of culture in informing legal and practical standards as to who should speak for an incapacitated patient what is meant by "close family"? the students also considered the "best 42. id at 45-87. 43. /d. at 99. 44. id at 101. 45. id at 102. for an interesting discussion of the court's use ofliterary references, see frank pasquale, why narratives do (and should) matter in bioethics, health reform watch (mar. l 0, 2011 ), http://www.healthreformwatch.com/2011/03/l 0/wby-narratives-do­ and-sbould-matter-in-bioethics/. 46. /d. at 101. 47. /d. at 99-100, 108. 2012] teaching heal til law in rural etiiiopia 495 interest" of the patient as expressed in the cases cited by shanbaug and how that standard or the "substituted judgment" standard could be applied to ms. shanbaug's situation.48 the students voiced thoughtfully mixed views on the equity issues raised by the case. many expressed admiration of the exceptionally high level of nursing care ms. shanbaug received. some of those students joined others in arguing that it was not a good use of resources in a country where. so many struggle to access basic care. furthermore, for a typical in­ dian in her situation, wouldn't lack of access to hospitalization or inability to pay for its continuation be determining factors in her case? this question led to a lively discussion about the appropriateness of personal connections in facilitating medical treatment. ms. shanbaug has occupied a hospital bed for nearly forty years not because an explicit government policy or because of her great wealth but apparently because of a personal connection with the hospital nurses and their sense of obligation to her.49 the first of two required papers, due at the end of the second week, was about shanbaug. this paper was to be no more than five pages and include three sections: issue; ethiopian context; and assessment. for the issue section, students were to describe the main legal issues before the in­ dia supreme court and its resolution of those issues. next they were to describe their understanding of the current state of these issues in ethiopia, with reference to at least one source outside of the required readings. as specified in the syllabus, the students were free to work collaboratively to uncover these additional sources, which could be statutes, regulations, cas­ es, commentaries, health practice guides, medical journal notes, news arti­ cles or popular media depictions from ethiopia or another aftican country. finally, they were to present their opinions about the shanbaug case and its relevance or lack of relevance in ethiopia. as to this last section, i was pleased to see a range of well-articulated views. in the middle section, the additional sources were not as illuminating or varied as i had hoped. although i had deliberately allowed a range of sources, i had not anticipat­ ed the research challenges. the students had only a few days to do this re­ search, computer access is limited, and the internet was down most of the time. ethiopia's civil and criminal codes became the default additional source material. v. pepfar par1nership frameworks and population health for the second half of the haramaya law class, i planned to focus on 48. for a very good discussion of these and other comparative health law issues, see timotiiy stoltzfus jost, readings in comparative health law and bioetihcs (2d ed. 2007). 49. indeed, according to rao, supra note 38, at 655, the kem staff objected to efforts to move her elsewhere to free up the hospital bed. 496 indiana health law review [vol. 9:2 the role of the law in promoting population health, ideally with some speci­ ficity as to ethiopia. in a timely bit of symbiosis, in the fall of 2010 i was part of a multidisciplinary team from the university of washington that was in the planning stages of a project related to the u.s. president's emergency plan for aids relief (pepfar) in africa.50 the project centers on the health policy reforms identified in pepf ar partnership frameworks (pf).51 and in late october 2010, ethiopia's pf was signed, setting up the possibility of problem-based learning related to some of its provisions. 52 as of january 2012, there are nineteen country-specific pfs and two regional pfs.53 each pf begins with data about the country's health indica­ tors and health systems, both as to idv/aids and also more generally. this section could be part of a short introductory summary for a health law course. the policy reforms detailed in these pfs include both specific and general proposals. malawi's, for example, states that its ministry of health . "expects to ... chang[e] 'anonymous' reporting to 'confidential' reporting in order to permit a name-based referral system. "54 this sort of specific proposal lends itself to discussions about confidentiality, mandatory report­ ing rules, and roles of public health agencies, as well as processes for changing legally enforceable standards. swaziland's includes a goal of "improv[ing] the status and rights of women, people living with mv and aids (plwha) and other vulnerable groups."55 this sort of general pro­ posal invites discussion about the · role of human rights and anti­ discrimination laws in promoting health. the pfs involve a number of common policy areas. these are human resources for health, mv testing and counseling, laboratory standards, or50. the project has since been funded as a cooperative endeavor with the centers for disease·control (cdc), the united states agency for international development (usaid) and futures group, a global health consulting firm. it aims to support the advancement of health-care related policy and law reforms identified in the pfs. as an initial phase of this multi-year project, in 2012 we will collaborate with in-country partners to host regional workshops focused on monitoring identified health policy reforms. 51. pepfar began in 2003. pepfar's 2008 reauthorization shifts the program's focus "from. an emergency response to promoting sustainable country programs." this se­ cond phase of pepf ar includes partnership frameworks ("pfs"), "5-year joint strategic ftamework[s] for cooperation between the [united states government], the partner govern­ ment, and other partners to combat hiv/aids in the country through technical assistance and support for service delivery, policy reform, and coordinated financial commitments." partnership frameworks: introduction, u.s. president's emergency plan for aids r.elmf, http://www.pepfar.gov/guidance/ftamework/1205 13.htm (last visited june 10, 2012). 52. thanks to amy hagopian, ph.d., for this suggestion. 53. for a current list, see partnership frameworks, u.s. president's emergency plan for aids relmf, http://www.pepfar.gov/ftameworks/index.htm (last visited june 10, 2012). 54. partnership framework document to support implementation of the malawi na­ tional hiv and aids response, u.s.-malawi, may 18, 2009, at 6, available at http://www.pepfar.gov/ftameworks/malawil'mdex.htm. 55. swaziland partnership framework on .hiv and aids 2009-2013, u.s.-swaz., june 4, 2009, at 3, available at http://www.pepfar.gov/ftameworks/swaziland/index.htm. 2012] teaching health law in rural ethiopia 497 phans and vulnerable children, and nondiscrimination. these areas will not reflect the full gamut of public health law issues of importance to a country. but-if the pfs are to be meaningful-they should reflect country-specific areas of concern and possible change. for some pfs, there are now related partnership framework imple­ mentation plans that address issues such as prioritization, implementation options, barriers to change, and evaluation criteria. 56 does a guideline need revising? a regulation adopted? a law enacted? are there stakeholders with a particular interest or expertise in the area? are there government agencies with particular responsibility? what are the barriers to change? how will priorities be identified? how will progress be monitored and evaluated? these issues and more can be addressed in the implementation plans. taking a broader approach in an academic setting, the pfs and relat­ ed implementation plans lend themselves to consideration of the efficacy of legal enactments and international declarations in actually supporting health system and health status improvement. ethiopia's pf includes proposed legal and policy reforms aimed at "addressing [ethiopia's] mv epidemic, as well as [supporting the ethiopi­ an government's] commitment to the broader health needs of its people."57 the reforms are grouped into four broad categories: prevention; quality care, treatment and support; health system; and health governance. an ex­ tensive course could be built around these topics. i assigned an edited version of ethiopia's pf for use in four class ses­ sions and for the second paper. we began with the ethiopia pf overview sections and considered generally how the hn i aids epidemic in africa has impacted key areas of health law and policy. 58 in the following class, we considered goals of universal access to primary care and of a national insurance system as expressed in ethiopia's pf.59 these topics were enliv­ ened by a discussion of how private payments enter into ostensibly free health care. a tanzanian newspaper article provided the springboard by 56. partnership framework implementation plans, u.s. president's emergency plan for aids relief, http://www'.pepfar.gov/guidance/framework/120732.htm (last visited june 8, 2012). 57. summary of the hiv/aids partnership framework wl1ll the government of the federal democratic republic of etihopia. u.s. president's emergency plan for aids relief l, http://www.pepfar.gov/documents/organization/154220.pdf (last visited june 4, 2012). 58. for a helpful overview in this regard, see peri h. alkas & wayne x. shandera, hjv and aids in africa: african policies in response to aids in relation to various na­ tional legal traditions, 17 j.l. meo. 527, 527-29,538-43 (1996) (discussing laws of more than a dozen countries, including ethiopia). 59. regarding health insurance systems in other african countries, see generally joio l. carapinha et al., health insurance systems in five sub-saharan african countries: med­ icine benefits and data for decision malcing, 99 healrn pol'y 193 (2011) (discussing characteristics of different types of health insurance systems and comparing programs in ghana, kenya, nigeria, tanzania, and uganda). 498 indiana health law review [vol. 9:2 citing a study that bribery was common in thatcountry'-s hospitals.60 sever­ al students related anecdotes that for non-emergency care or for a family member to stay with a hospitalized patient, payment might be expected, if only to the facility's guard. while anecdotes are low-grade data, this dis­ cussion did help focus consideration on the role of the law in ensuring '<uni­ versal access," however that is defined 61 we next studied the ethiopia pf sections on the patient counseling and treatment experience, with particular emphasis on issues of confidenti­ ality. how can statutory or regulatory standards appropriately encourage testing, ensure confidentiality, and also protect third parties? in this class session and in their papers, several students expressed strong and divergent ·views on appropriate legal standards for partner notification.62 finally we considered the law's potential roles in workforce retention and regulation. ethiopia is one of the fifty.,.seven countries recognized by the world health organization as· having a health workforce crisis. as de­ scribed in ethiopia's pf, the country is one of many with a severe shortage of physicians and nurses; in·2010, for example, there were only 2151 physi­ cians in the country, a ratio of about 2.72 for every 100,000 people.63 this shortage is exacerbated by migration of health care workers to high-income countries and to administrative positions within non-governmental organi­ zations based in ethiopia. 64 my students were aware that shortages are par­ ticularly acute in rural areas, such as the region in which haramaya university is located. they were also aware of hu' s new medical school and the rapid expansion of the student body on the harar campus. the second paper, due at the end of the course, was about ethiopia's pf. it was to be no more than five pages and include the following three sections. in the "issue" section, students were to identify one of the policy goals expressed in ethiopia's partnership framework, explain the purpose of the goal, and, in general, the possible role of the law in its advancement. ·for the "ethiopian context" section, they were to describe the current·state 60. corruption common in hospitals, says ngo, daily news (tanzania), oct 10, 2010 (on file with author), available at http://dailynews.co.tzlhomel?n= 13702. 61. many of my students were well aware of the passage in the united states of the affordable care act of 2010 and its controversial attempt to the expand health insurance coverage in this country. 62. useful case studies are collected in s.b. odunsi & a.o. nwafor, medical confi­ dentiality: right of hiviaids patient and the third party interest, 16 lesotho l.j. 249 (2006) (with particular attention to ethical and legal standards in nigeria, ethiopia, and aus­ tralia). 63. ethiopia pf, supra note 2, at 6-8. by comparison, in 2010, there were about 850,000 actively licensed physicians in the united states, a ratio of 277 for every i 00,000 people. see murphy, supra note 7; aaron young et al., a census of actively licensed phy­ sicians in the united states, 2010, 96 j. med. regulation 10 (2011), available at http://www.fsmb.org/pdf1pub-journal-census.pdf. 64. see, e.g., samuel girma et al., human resource development for health in ethio­ pia: challenges of achieving the millennium development goals, 21 em. j. healm dev. 216 (2007). 2012] teaching health law in rural ethiopia 499 of this issue in ethiopia, with reference to at least one source from outside of the required readings. finally, they were to provide their opinion regard­ ing the scope of the issue in ethiopia, possible ways the law might address it, and likelihood of success. as with the first paper, the outside research was not as robust as i had hoped; not only was the internet mostly unavaila­ ble, but an extended easter holiday cut into class time. other articles in this indiana health law review issue discuss collab­ orative, problem-based courses involving students from law and health sci­ ences schools in the united states. that sort of collaborative education could be fruitfully designed around many of the pf topics. indeed, the orig­ inal plan for my course was to include students from the harar campus, but that proved to be too difficult logistically. even iflogistics preclude a mul­ tidisciplinary course, lectures from faculty in an affiliated health sciences school could help clarify some of the practical issues around the law and policy options. i certainly met faculty whose research interests dovetailed neatly with the topics we covered. vi. some practical observations there are several articles on the pedagogical and practical issues with foreign faculty teaching law in low-income countries.65 in recognition of that body of literature, i will make here only a few practical observations about my experience as a white american accustomed to teaching at a long­ established, urban law school with a new, technologically advanced build­ ing and an extensive law library.66 first, i wish i had had a better appreciation of the resource limitations. an initial draft of my law course syllabus stated that the required papers were to be "double-spaced." law school dean richard wentzell, jd, ph.d, pointed out that few students had reliable access to computers and even fewer to a printer; papers are typically handwritten on unlined paper.67 despite this reminder about technology limitations, i persisted in a course design that prominently relied on the students researching the state of ethi­ opia's law on various issues. when hu' s law library is completed and as internet access becomes 65. see, e.g., peggy maisel, the role of u.s. law faculty in developing countries: striving for effective cross-cultural collaboration, 14 clinical l. rev. 465 (2008) (con­ trasting efforts from the "law and development" era with current approaches, with reference to several articles detailing professors' experiences). see also kirsten a. dauphinais, train­ ing countervailing elite: the necessity of an effective lawyering skills pedagogy for a sustainable rule of law revival in east africa, 85 n.d. l. rev. 53 (2009). 66. william h. gates hall, with its marian gould gallagher law library, is located on the university of washington campus in seattle, washington. see gallagher law li­ brary, univ. of washington, http://lib.law.washington.edu/ (last visited june 6, 2012). 67. there is a lot of eyestrain, i learned, in reading 166 handwritten papers, particular­ ly by flashlight when the power is out. 500 indiana health law review [vol. 9:2 more reliable and available, legal research should be easier. it still might not be easy, particularly in a short time-frame. in his article about "mis­ takes made and lessons learned" teaching securities regulation in uganda, stuart r. cohen writes that he had not appreciated how hard it would be to track down the relevant legal authorities and that "one of the most appreci­ ated byproducts of our course was a notebook that included all relevant statutes and regulations."68 second, and relatedly, it proved important to be flexible. university structures and processes were much more fluid than those at the university of washington. to meet·with the hu president, for example, one looked for his car next to the administration building and then sat in his waiting area until he was available. the composition, structure, and timing of my law and nursing classes shifted up until the last minute. with the easter holiday and other scheduling conflicts, a few class times had to be changed; this proved surprisingly easy where faculty and staff live on campus, bulletin board postings serve as effective communica­ tion, and nearly everyone seems to walk by the outdoor cafes at some point during the day. although i had made an effort to learn about cultural issues that might impact teaching, i was continually learning new things. for ex­ ample, for one class session all the women showed up but nearly all of the men were absent; i was told that a student's father had died, and as is cus­ tomary, the student's same-gender classmates had gathered with him. third, having my family there enhanced the visit. my book-learning about rural health care in ethiopia was made concrete by my husband's ob­ servations at hiwot fana hospital and his discussions with physicians, medical officers, nurses, and medical students. what a "shortage of physi­ cians" looks like is a medical officer seeing a couple dozen patients in an hour and making diagnoses based primarily on physical exam. what "de­ lays in seeking conventional medical treatment" looks like is a toddler with a huge tumor on his back. my sons' experiences at the local public school also helped my teach­ . ing. i had heard that the law students were most used to chalkboard lectures and that they were very good at memorizing. i appreciated that background better when nate and henry reported that their classes involved a great deal of copying from chalkboards into composition books and memorization. among other differences from their public schools in seattle, the ethiopian teachers carried and sometimes used switches, the curriculum included sev­ eral science classes, and the recesses were more fun, with intense soccer games.69 68. stuart r cohn, teaching in a developing country: mistalres made and lessons learned in uganda, 48 j. legaleduc. 101, 104 n.10 (1998). 69. although there were several other foreigners on campus, oms were the only white children. on the campus as a whole, there were a number of faculty members from india, a few ftom the united states, and several volunteers services oversees personnel from com2012] teaching health law in rural ethiopia 501 i never did see the on-campus hyenas, though nate and chris did on a walk at dusk through the agricultural fields. i did see the hyenas that come to one of the harar gates each evening to be fed strips of camel meat the "hyena man" offers on a stick. the hyenas are skulking and mangy, with muscular shoulders and large jaws. although i know faculty members and students who have fed the harar hyenas, i refrained. the on-campus hye­ nas do not seem to require much accommodation beyond bringing livestock and pets in at night. in the days leading up to the easter feasts, many goats were staked outside the hu apartments. at dusk they were walked inside and up the stairs, to spend the night bleating on apartment balconies. vll. conclusion i would be interested to learn about the structure of other health law and policy courses in low-income countries with rapidly expanding health systems. as their systems expand, i expect that health law and policy will be an area of increasing academic and practical interest at a number of uni­ versities. there is certainly a burgeoning interest in the united states in global and comparative health law. perhaps my experience teaching at haramaya university can help vis­ iting or resident law faculty prepare similar courses. i certainly found that the shanbaug case and ethiopia's pf helped shape an engaged course. the case, with its compelling factual background, surveys medical decision­ making law from a variety of jurisdictions and considers its applicability to india's legal and cultural context. the pf facilitates a shift in focus to the law's potential role in supporting population health. my limited beta test of these materials suggests that they successfully engage law students in considering important areas of health law and poli­ cy. depending on available time and resources, they could provide a springboard to student investigation of the state of those areas, legally and practically, in a given country. the topics also would seem to lend them­ selves well to interdisciplinary collaboration with health sciences schools and, potentially, to linkages with lawyers, regulators or stakeholders in­ volved in health policy reform. i look forward to hearing about courses like these. monwealth countries. the ethiopian children were well-versed in united states politics; one student asked nate what he would do if sarah palin became president. how old is too old?: the need for federal regulation imposing a maximum age limit on women seeking infertility treatments melissa reynolds· i. introduction ............................................................................... 277 a. infertility technologies-generally ......................................... 280 b. success of infertility treatments .............................................. 283 ii. why infertility treatments should not be utilized by women of advanced-age ......................................................... 284 a. decrease in egg quality and reproductive organ health associated with increasing age ............................................... 284 b. risks to both the child & the mother ...................................... 285 1. miscarriage ....................................................................... 285 2. stillbirth ............................................................................. 285 3. premature birth and low birth weight ............................ 286 4. chromosomal abnormalities ............................................. 287 5. pregnancy-related dangers ............................................. 288 ill. current state of regulation in the united states ........... 290 a. indiana ..................................................................................... 292 b. nongovernmental organizations ............................................. 293 iv. federal regulation is needed in the united states .......... 294 a. why regulation is needed ....................................................... 294 b. substantive due process framework ...................................... 298 1. different levels of review ................................................. 298 a. strict scrutiny .............................................................. 299 b. intermediate scrutiny .................................................. 299 c. rational basis ............................................................. 299 d. which standard of review applies ............................. 299 2. governmental interests advanced by restricting access to infertility treatments based upon age ............................. 301 v. conclusion .................................................................................. 303 i. introduction in january 2005, adriana iliescu gave birth in romania at the age of sixty-six. 1 iliescu underwent in-vitro fertilization using both egg and sperm * j.d. candidate, 2010, indiana university school of law-indianapolis; b.s., 2007, indiana university. l. the associated press, romanian woman, 66, gives birth to baby girl; doctors say she is the world's oldest mother ever recorded, jan. 17, 2005, http:l/www.msnbc.msn.com/ id/6835044/ (last visited march 13, 2009) [hereinafter ap, romanian woman]. 278 indiana health law review [vol. 7:277 from anonymous donors.2 lliescu was initially pregnant with triplets, but one of the fetuses was lost after nine weeks and another baby was stillborn.3 at tb.attime, lliescu was believed to have been the world's oldest woman to give birth.4 ·at the age of sixty, frieda birnbaum gave birth to twins in may of 2008.5 birnbaum was already the mother of three children-ages six, twen­ ty-nine,· and thirty-three;6 birnbaum and her husband stated they wished to have another child in order for their six-year-old to have a sibling close to his age; and also ''to remove some of the stigma attached to older women giving birth. "7 omkari panwar, at the age of seventy, underwent infertility treatments in the hopes of conceiving a boy after having two daughters and five grand­ daughters. 8 panwar gave birth to twins, a boy and a girl, in india in july 2008. also in india, approximately four months after panwar gave birth, rajo devi and her husband, ages seventy and seventy-two, respectively, welcomed a baby girl born two months prematurely.9 devi, who had un­ dergone menopause twenty years prior, conceived with the help of a donor egg and ivf .10 along with the advent and wide-spread usage of infertility treatments bas come an increase in the use of such technology by older women. be­ fore infertility treatments were available, a post-menopausal woman had no chance of conceiving and giving birth. the once impossible, however, is now possible--infertility treatments allow a woman past the age of meno­ pause to carry and give birth to a child. today, the news is full of stories of women in· their fifties, sixties, or even seventies, giving birth to children with the assistance of reproductive technologies. "in the [united states], between 1980 and 2004, the proportion of all births increased ... nearly [four}.fold in women aged" forty years, and "first births [for this age group] increased [fifteen]-fold."11 studies have suggested that since 1997, there 2. ld. 3. ld. 4. id 5. the assoeiated press, sixty-year-old n.j. woman delivers twins; believed to be the oldest mom in u.s. to give birth to multiples, may 24, 2007, ht1p://www.msnbc.msn.com/ id/18817248/ (last visited march 13, 2009) [hereinafter ap, n.j. woman]. 6. ld. 7. id. 8. arthur caplan ph.d., new ivf dilemmas make old fears seem quaint; twins for a 70-year-old? louise brown's doctors didn't envision this, july 24, 2008, http:// www.msnbc.msn.com/id/25837220/ (last visited march 13, 2009). 9. lisa belkin. the new york times, 70-year-old woman gives birth, dec. 9, 2008, http://parenting.blogs.nytimes.com/2008/12109/pregnant-at-70nscp='4&sq=birth&st=cse (last visited march 13, 2009). 10. ld. 11. barbara luke & morton b. brown, elevated risks of pregnancy complications and adverse outcomes with increasing maternal age, 22 human reproduction, 1264, 1264, feb. 8, 2007, available at htlp://humrep.oxfordjournals.org/cgilcontentlfullldel522vl (last 2010] how old is too old? 279 has been an average increase of fourteen percent per year in births to wom­ en fifty years of age and older.12 an ever increasing number of women are deciding to postpone starting a family for a variety of reasons. many wom­ en are choosing to frrst pursue advanced degrees, while others are waiting until after they have developed and settled into their careers to start a fami­ ly. additionally, many of these older women are now able to take advan­ tage of recent technology, not available in their younger years, that assists them in conceiving.13 also, as previously discussed, some women are tak­ ing advantage of reproductive technology later in life for reasons such as having a child of one sex or the other. 14 whatever the reason, many of these women are forced to turn to infertility treatments, as a woman's fertil­ ity declines with age. currently, the average age of menopause in the united states is fifty­ one/5 but the age range is age forty-five to age fifty-five. 16 past the age of fifty, most pregnancies will require some type of assistance, whether it is in the form of fertility drugs, hormones, or donated eggs. 17 the few women who continue to ovulate after the age of fifty, and are successful in conceiv­ ing, typically must take hormones. 18 these hormones are essential· in order to even maintain the pregnancy, as most of these women's bodies have ceased producing the hormones necessary to support a pregnancy.19 the use of reproductive technologies by post-menopausal women in the hopes of conceiving a child is troubling for many reasons. this note will discuss the utilization of infertility treatments by wom­ en of advanced age, and the problems associated with such use. part i of this note will discuss background information regarding the technology involved in treating infertility. part ll of this note will discuss the problems involved with women of advanced age using infertility treatments, and will mention statistics associated with such advanced-age births will also be visited march 13, 2009). the year 1997 is the first year that statistics involving births to women fifty years of age and older were available. ld. at 9. 12. ld. 13. see american society for reproductive medicine, third party reproduction, a guide for patients (sperm, egg, and embryo donation and surrogacy), available at http://www.asrm.org/patients!patientbookletslthirdparty.pdf (last visited feb. 14, 2009) [he­ reinafter asrm, third party reproduction]. according to the american society for repro­ ductive medicine, the first pregnancy resulting from egg donation did not occur until 1984. id. at4. 14. see supra part i. introduction (discussing the case ofomkari panwar). 15. commitiee on gynecologic practice, the american college of obstetricians and gynecologists, commitiee opinion no. 413, age-related fertility decline, at 1 (2008), available at http://www.asnn.org/media/practice/age­ relatedfertilitydecline.pdf (last visited nov. 8, 2008) [hereinafter opinion no. 413]. 16. laura f. mccarthy, pregnancy at 20, 30, 40; is there a perfect time to have a baby?, babytalk, dec. 2000/jan. 2001, at 86, available at http://www.parenting.com/ pregnancy/article/pregnancy-at-20-30-40 (last visited april4, 2010). 17. id 18. id. 19. id. 280· indiana he.t\l1h law review [vol. 7:277 mentioned. part iii of this note will discuss the united states' current state of regulation in the area of reproductive technologies, both at the state and at the federal levels. part n of this note will discuss the need for regula­ tion in the area of assisted reproduction, as well as possible substantive due process issues. although there may be a potential equal protection chal­ lenge to the federal regulation proposed in this note, because it pertains to women alone, only the issues accompanied by advanced-age pregnancies for the mother and prospective child will be addressed. while there are many areas within the field of assisted reproduction that potentially could be regulated, this note focuses exclusively on the need for federal regulation imposing a maximum age limit on women seek­ ing infertility treatments. part v concludes that federal regulation imposing a maximum age limit on women seeking access to infertility treatments is necessary and is justified in light of the strong interests advanced by such regulation. a. infertility technologies-generally health care providers use the term "infertility" to describe: women who are unable to get pregnant, and ... men who are unable to impregnate a woman, after at least one year of trying. hi women, the term is used to de­ scribe those who are of normal childbearing age, not those who can't get pregnant because they are near or past menopause. women who are able to get preg­ nant but who cannot carry a pregnancy to term (birth) may also be considered infertile.20 consequently, a woman who cannot conceive due to the fact that she is past menopause is not really "infertile," as that term is used by those in the health care industry. infertility can be caused by many different individual factors, or a combination of factors, including environmental factors, genetic conditions, or health issues.21 there are a variety of procedures available for treating female infertility. those procedures that involve the handling of both eggs and sperm are known as "assisted reproductive technologies" ("art").22 20. national institute of child health and human development. infertility/fertility, whot is infertility?, http://www.nichd.nih.gov/healthltopicsfmfertility_fertility.c:tin (last vi­ sited nov. 8, 2008). 21. ld.; see id. for a more thorough discussion of. the potential causes of both female and male infertility. 22. centers for disease control and prevention, department of health and human services, what is assisted reproductive technology (art)?, http://www.cdc.gov/art (last 2010] how old is too old? according to centers for disease control and prevention, art procedures involve surgically removing eggs from a woman's ovaries, combining them with sperm in the laboratory, and returning them to the woman's body or donating them to another woman. they do not include treatments in which only sperm are han­ dled (i.e., intrauterine-or artificial insemination) or procedures in which a woman takes medicine only to stimulate egg production without the intention of hav­ ing eggs retrieved. 23 281 in 2002, the american society for reproductive medicine ("asrm'') determined that the use of arts resulted in the birth of almost one in every hundred babies born in the united states. 24 based upon reported births, between the years 1985 and 2006, the use of arts led to approximately 500,000 children born in the united states.25 additionally, the 2006 art report, currently the most recent report published by the centers for dis­ ease control, estimates that ten percent of all reported art services were used by women over the age of forty-two. 26 this number is up from four percent in 2005.27 in 1981, nf was introduced in the united states.z8 ivf involves the surgical removal of eggs from a woman's ovary and then the combination of these eggs with sperm outside of the body.z9 thus, the actual fertiliza­ tion process occurs outside of the woman's body. if these eggs are successvisited nov. 8, 2008) [hereinafter cdc, what is art?]. 23. id 24. american society for reproductive medicine, frequently asked questions about irifertility -does in vitro fertilization work?, http://www.asrm.org/patients/faqs.html#q7: (last visited july 21, 2009). 25. ld 26. centers for disease control and prevention, american society for reproductive medicine, society for assisted reproductive technologies, 2006 assisted reproductive technology success rates: national summary and fertility clinic reports, at 15 (2008), available at http://www.cdc.gov/art/art2006/508pdf/2006art.pdf (last visited april 4, 2010) [hereinafter cdc, 2006 art report]. the purpose of the annual art report is to assist interested individuals in determining where to obtain treatment, as well as informing those individuals of a clinic's success rate. cdc, what is art?, supra note 22. 27. victoria c. wright et al., assisted reproductive technology surveillance-united states, 2005, centers for disease control and prevention (june 20, 2008), available at http://www .cdc.gov/mmwr/preview/mmwrhtml/ss5705a1.htm?s..:.. cid=ss5705a 1_ e (last vi­ sited march 13, 2009); fertility clinic success rate and certification act of 1992, 42 u.s.c.a § 263a-l et seq. (west 1992). 28. american society for reproductive medicine, frequently asked questions about infertilitydoes in vitro fertilization work?, http://www.asrm.org/patients/faqs.html#q7: (last visited july 21, 2009). 29. american society for reproductive medicine, frequently asked questions about injtertilitywhat is in vitro fertilization?, http://www.asrm.org/detail.aspx?id=3022 (last visited april4, 2010) [hereinafter asrm, what is in vitro fertilization?}. 282 indiana health law review [vol. 7:277 fully fertilized and begin to divide, they· are inserted into the woman's rus.jo once an egg has been fertilized, it is then referred to as an "embryo." nf accounts for more than ninety-nine percent of all art procedures per­ formed in the united states.31 nf, however, "accounts for less than five percent of all infertility treatment in the united states," because not all in­ fertility treatments are considered "art procedures. '.32 two other commonly used art procedures exist. zygote intrafallo­ pian transfer ("zift"),lik:e nf, the fertilization of the egg occurs outside of the woman's body.33 once the eggs and sperm are combined and fertili­ zation occurs, the embryos are inserted into a woman's fallopian tube.34 gamete intrafallopian transfer ("gift'') is the other commonly used art procedure that differs from nf in that the fertilization process occurs in­ side of the woman's body, as opposed to occurring outside the body, in a petri dish.35 eggs are retrieved from a woman's ovary, and then the eggs, with sperm, are immediately inserted into a woman's fallopian tubes.36 on­ ly women with normal fallopian tubes may utilize gift.37 yet another option is cryopreservation. a woman's eggs or a man's sperm can be preserved by freezing them for later use. cryogenic technol­ ogy also allows for an embryo to be frozen for later use. cryopreservation involves the immersion of embryos, or eggs or sperm, in liquid nitrogen "between the time [the zygote] reache[s] the two-cell or eight-cell stage.'.j8 then, when the embryo, eggs, or sperm are needed, they are thawed and inserted into a woman's uterus during her menstrual cycle.39 finally, there is artificial insemination. in artificial insemination, a physician uses a thin tube called a catheter to introduce sperm "directly into a woman's cervix, fallopian tubes, or uterus. this makes the trip shorter for the sperm and bypasses any possible obstructions.'o40 when the sperm is 30. id 31. cdc, 2006 art report, supra note 26 at 89. 32. asrm, what is in vitro fertilization?, supra note 29. 33. society for assisted reproductive technologies, assisted reproductive technolo­ gies, http://www.sart.org/guide_assistedreproductivetechnologies.html (last visited nov. 8, 2008). 34. id. 35. id. 36. id. 37. american society for reproductive medicine, assisted reproductive technologies: a guide for patients 10 (2008) available at hup://www.asrm.org/patients/ patientbooklets/art.pdf (last visited feb. 14, 2009) [hereinafter asrm, assisted reproductive technologies). 38. kimberly e. diamond, cryogenics, frozen embryos and the need for new means of regulation: why the u.s. is frozen in its current approach, 11 n.y.int'l l. rev. 77, 78-79 (1998). 39. id. at 79. 40. a couples guide: trying to conceive; artificial insemination, reviewed by mikio a. nihira, m.d., webmd, http:/lwww.webmd.comlinfertility-and-reproduction/guide/artificial2010] how old is too old? 283 placed in the woman's uterus, as opposed to the fallopian tubes or cervix, the procedure is called intrauterine insemination ("iui").41 b. success of infertility treatments by the age of thirty, a woman's fertility starts to decline, dropping significantly. at the age of thirty-eight.42 since 1996, the centers for dis­ ease control and prevention (''cdc") has been collecting data via a web­ based collection system regarding art procedures performed in medical centers throughout the united states, as required by the fertility clinic success rate and certification act of 1992 ("fcsrca").43 this data col­ lection system is called the national art surveillance system (''nass").44 according to the assisted reproductive technology surveillance, 134,260 art procedures were performed in 2005.45 these procedures led to 38,910 live':"birth deliveries, and 52,041 babies were born as a result.46 the higher number of babies born as compared to the number of deliveries is due to the birth of multiples. in 2005, according to reports, the average live-birth rate for art procedures involving the use of a woman's own eggs was thirty­ four percent.47 this art success rate decreased significantly "from [forty­ three] percent among women [under the age of thirty-five] to [six] percent among women [over the age of forty-two ].'"'8 according to the 2006 art report, for women over the age of forty-four who underwent arts using fresh non-donor eggs or embryos, the rate of live births was only approx­ imately one percent.49 the success rate ofivf in women under the age of thirty-five is twen­ ty-five to twenty-eight percent, and for women over the age of forty, the success rate significantly decreases to six to eight percent. 50 in 2006, the percentages of gift and zift procedures resulting in live births that year were approximately twenty-four percent and almost eighteen percent, re­ spectively.51 insemination (last visited nov. 8, 2008). 41. ld. 42. mccarthy, supra note 16. 43. wright et al., supra note 27; fertility clinic success ~ and certification act of 1992,42 u.s.c.a. § 263a-1 et seq. (west 1992). 44. wright et al., supra note 27. 45. id. 46. id. 47. id. 48. /d. 49. cdc, 2006 art report, supra note 26, at 27. · 50. mccarthy, supra note 16. 51. cdc, 2006 art report, supra note 26, at 40. 284 indiana health law review [vol. 7:277 it. why infertiuty t~tments should not be utilized by women of advanced-age a. decrease in egg quality and reproductive organ health associated with increasing age fertility-harming disorders, such as fibroids, endometriosis, and tubal disease, increase with age.52 ovarian aging, meaning a decrease in egg quality, not quantity, appears to be one cause of the increasing risk of infer­ tility as a woman ages. 53 according to benjamin younger, m.d., executive director of the american society ofreproouctive medicine, as a woman's eggs age, fertilizing them becomes difficult 54 . in addition, as women age, there is "a significant increase in the rates of aneuploidy and spontaneous abortion. "55 the increased rates of aneuploidy and spontaneous abortion occur because, as a woman and her eggs age, her eggs "are more likely to have genetic abnormalities."56 aneuploidy is defined as "[t]he occurrence of one or more extra or missing chromosomes leading to an unbalanced chromosome complement, or, any ~hromosome number that is not an exact multiple ofthe haploid number."57 one specific form of aneuploidy causes of down syndrome. down syndrome can result from having three, as op­ posed to two, copies of the twenty-first chromosome.58 tri~my occurs in approximately two percent of pregnancies among wom~ under the age of twenty-five, and the risk increases· to almost thirty-five percent among women over the age offorty.59 down syndrome.can also be caused when only some cells having an extra copy of the twenty-first chromosome, or ''when part of the [twenty-first] chromosome becomes attached [translo52. 0pinionn0.413,supranote 15,at l. 53. european society of human reproduction and embryology workshop group, fertility and ageing, 11 human reproduction update· 261, 261 (2005), available at http:/lhumupd.oxfordjoumals.org/cgi/reprint/1113/261 ?maxtoshow--&hits= 1 o&hits= 1 o&r esultformat=&fulltext=fertility+and+ageing&searcbid=1&firstindex=o&resource type=hwcit (last visited march 13, 2009). 54. mccarthy, supra note 16. 55. opinion no. 413, supra note 52, at i (citing ww newcomb, m rodriguez, and jw johnson, reproduction in the older gravida. a literature review, 36 j. reproo. mbd. 839 (1991)). 56. american society for reproducitve medicine, age and fertility: a guide for patients 6 (2003), available at http://www.asnn.~atientslpatientbooldets/ agefertili­ ty.pdf(last visited feb. 14, 2009) [hereinafter asrm, age and fertility]. 57. u.s. national library of medicine, genetics home reference, aneuploidy, http://ghr.nlm.nih.gov/glossary=aneuploidy (last visited jan. 7, 2009). 58. mayo clinic stafl: down syndrome causes, m;\y{)_cunic.com, april 7, 2009, http://www.mayoclinic.com/health/down-syndrome/dsool82/dsection=caus.es (last visited april4, 201 0). [hereinafter mayo clinic, down s}'fldrome causes} · 59. european society of human reproduction and embryology, supra note 53, at 26768. 2010] how old is too old? 285 cated] onto anothet chromosome, before or at conception . ..60 aside from these fertility-harming disorders, there are other more serious risks to the mother and child associated with a late-age pregnancy. b. risks to both the child & the mother 1. miscarriage according to studies, children born to women at the age of forty ''were more likely to be premature, have low birth weight, and· be admitted to in­ tensive care units.'.61 also, the rate of miscarriage increases sharply as a woman ages. for women aged thirty-three to thirty-four years, the rate of miscarriage isalmost eleven and a balfpercent.62 for women aged thirty­ five to thirty-seven years, the miscarriage rate is thirteen and seven-tenths percent, and nineteen and eight-tenths percent for women aged thirty-eight to forty years.63 in women aged forty-one to forty-two years and forty-two years and older, the miscarriage rate increase& to almost thirty percent and over thirty-six and a half percent, respectively. 64 the rate of miscarriage following ivf can be as high as fifty percent in women over the age offorty.65 in fact, according to the 2006 art re­ port, fifty-six percent of women over the age of forty-three· who utilized arts using fresh non-donor eggs or embryos suffered a miscarriage.66 miscarriage is the end result in approximately one-third of all pregnancies occurring in women aged forty to forty-four years.67 some reasons for such a high rate of miscarriage include defective eggs, inadequate uterine lining, or an inadequate blood supply to the uterus.68 2. stillbirth another high risk associated with pregnancies of older women is the risk of a child born stillborn. stillbirth is defined as "death of the fetus after [twenty] weeks ofpregnancy.'o69 ''the risk of stillbirth is doubled for wom60. mayo clinic, down syndrome causes, supra note 58. 61. european society of human reproduction and embryology, supra note 53, at 273. 62. /d., at2. 63. /d. 64. id 65. keith a. byers, infertility and in vitro fertilization: a growing need for con­ sumer-oriented regulation of the in vitro fertilization industry, j. legal med. 18, 33 (1997). 66. cdc, 2006 art report, supra note 26, at 28. 67. mccarthy, supra note 16. 68. mccarthy, supra note 16. 69. march of ditties, pregnancy after 3'5, htlp:/lwww.marchofdimes.comlprofessionals/ 14332_1155.asp (last visited jan. 15, 2009) [hereinafter dimes, pregnancy after 35]. 286 indiana realm law review [vol. 7:277 en in their [forties], compared with those in their [twenties]."70 a real-life example of such risks was experienced by adriana lliescu, who was men­ tioned in the introduction to this note, as she lost two of the three fetuses she was carrying during her pregnancy.71 3. premature birth and low birth weight delivery is considered to be "premature" if it occurs before thirtyseven weeks.72 "women ages ... [forty] and older are more likely than women in their ... [twenties] and ... [thirties] to deliver prematurely (before ... [thirty-seven] completed weeks of pregnancy)"73 premature birth can be dangerous for the child. children born prematurely have a higher risk of experiencing health problems immediately following birth, as well as long-term disabilities. 74 a study conducted in 2006 found that babies born between thirty-four and thirty-six weeks "were more than three times as likely as full-term babies to be diagnosed with cerebral palsy and were also at increased risk for developmental delay or mental retardation.'m additionally, studies show the occurrence of low birth weight as well as very low birth weight increases with maternal age. 76 low birth-weight babies are at an increased risk for respiratory distress syndrome ("rds"), intraventricular hemorrhage ("ivh"), patent ductus arteriorsus ("pda"), necrotizing enterocolitis (''nec"), and retinopathy · of prematurity ("rop").77 rds is a breathing problem caused by a lack of surfactant, which keeps the air sacs in the lungs from collapsing.78 in order to keep a baby's lungs expanded, treatment with surfactant is necessary, as well as the ad­ ministration of oxygen and mechanical breathing. 79 ivh is bleeding in the brain, which, if severe, may cause pressure on the brain and lead to brain damage. 80 in such severe cases, physicians must insert into the baby's brain a tube in order to drain the accumulated fluid.81 pda occurs when the due70. mccarthy, supra note 16. 71. see ap, romanian woman, supra note 1. 72. dimes, pregnancy after 35, supra note 69. 73. /d. 74. id 75. robert preidt, late preterm birth poses developmental risks; caesarean or in­ duction should not be done before 39 weeks unless necessary, study says, medline plus, dec. 11, 2008, http://www.nlm.nih.gov/medlinep1uslnews/ful1story _72696.html. · 76. luke & brown, supra note 11, at 1265-66. 77. march of dimes, low birthweight: what medical problems are common in low­ birthweight babies?, http://www.marchofdimes.com/professionals/14332 _)153.asp (last visited jan. 16, 2009) [hereinafter dimes, low birthweight]. 78. /d. 79. id 80. /d. 81. /d. 2010] how old is too old? 287 tus arteriosus, a large artery allowing the baby's blood to bypass its lungs while in the womb, fails to close, potentially leading to heart failure.82 in order to treat pda, a drug is administered, and if this drug is ineffective, surgery is performed to correct the problem. 83 nec is an intestinal problem that develops a few weeks after birth. 84 babies suffering from nec are treated with antibiotics and fed intravenously until the baby's intestine has healed. 85 surgery to remove the damaged piece of intestine may be re­ quired in some cases. 86 "rop is an abnormal growth of blood vessels in the eye that can lead to vision loss."87 oftentimes, the condition is corrected without treatment, resulting in little or no vision loss. 88 in severe cases, however, treatment of the abnormal blood vessels with laser therapy or cryotherapy may be necessary in order to preserve the baby's vision.89 in addition to suffering from serious conditions as newborns, some studies· have suggested that babies born with a low birth weight "may be at increased risk for certain chronic conditions in adulthood," such as hyper­ tension, type ii diabetes, and heart disease. 90 4. chromosomal abnormalities as a woman ages, her likelihood of giving birth to a child suffering from down syndrome increases. again, down syndrome is caused by a chromosomal anomaly, which occurs when the child is born with three, as opposed to two, copies of the twenty-first chromosome. a twenty-year-old woman has a 1 in 1,667 chance of giving birth to a baby born with down syndrome, and a 1 in 526 chance of the baby having other chromosomal anomalies.91 chromosomal anomalies can be the cause of many different birth defects, encompassing physical, developmental .and mental disabili­ ties. at the age of thirty, a woman's risk of having a child born with down syndrome or some other chromosomal anomaly is 1 in 952 and 1 in 385, respectively.92 these rates begin to increase significantly from the ages of thirty-five to thirty-nine, when the likelihood of down syndrome and other chromosomal abnormalities increases to 1 in 3 78 and 1 in 192, respective­ ly.93 a forty-year-old woman has a 1 in 106 chance that of giving birth to a 82. dimes, low birthweight, supra note 77. 83. /d. 84. ld 85. /d. 86. id 87. dimes, low birthweight, supra note 77. 88. id 89. /d. 90. /d. 91. mccarthy, supra note 16. 92. mccarthy, supra note 16. 93. /d. 288 indiana health law review [vol. 7:277 child aftlicted with down syndrome and a ·1 in 66 chance a child will have some type of chromosomal anomaly.94 by the age of forty-nine, a woman's chances of having a child born with down syndrome or another chromo­ somal abnormality has increased to 1 in 11 and 1 in 8, respectively. 95 thus, in only nine years, a woman's chance of giving birth to a child afflicted with down syndrome rises from 1 in 106 to 1 in .11. these statistics illu­ strate the likelihood of having a child born with some type of genetic ab­ normality increases drastically as a woman ages. today, there are available methods for screening embryos for genetic abnormalities. before implantation of the embryo. one such method is called pre-implantation genetic diagnosis (''pgd").96 pgd involves the taking of one cell from an eight-cell embryo to test for genetic abnormali­ ties.97 lfit is determined that the embryo is genetically "normal," the emb­ ryo will then be transferred into the woman.98 as of 2006, approximately seventy-five percent offertility clinics offered pgd.99 in a study involving eighty infertility patients with an average age of forty years old,. sixty per­ cent of the embryos screened using pgd were found to have chromosomal abnormalities.100 while pgd may help some prevent the use of genetically abnormal embryos that would lead to chromosomal anomalies in a child, this test is· not always completely accurate because babies are nevertheless born with conditions for which the test was supposed to screen.101 also, as dis~ussed throughout this note, there are many ·other dangers associated with advanced age pregnancies that have absolutely nothing to do with the genetic make-up of an embryo. 5. pregnancy-related dangers • the results of a study conducted between 1995 and 2000 showed that "[i]ncreasing maternal age is associated with significantly elevated risks for pregnancy complications and adverse outcomes."102 according to other studies, women over the age of forty are more likely to suffer gestational diabetes, pregnancy-induced hypertensive disorders, and have instrumental deliveries and caesarean sections than younger women. 103 94. id. 95. id. 96. rick weiss, increasingly, couples use embryo screening, the washington post, sept. 21, 2006, at a02, available at http://www.washingtonpost.com/wp­ dyn/content/article/2006/09/20/ar2006092001652.html (last visited march 13, 2009). 97.: id. 98. /d. 99. jd. 100. kate johnson, age at issue in aneuploidy screening: questions raised about lvf screening practice, 39 ob. gyn. news 20, 20, sept. 1, 2004. 101. weiss, supra note%. 102. luke & brown, supra note 11, at 1264. 103. ew-opean society of human reproduction and embryology, supra note 53, at 273. 2010] how old is too old? 289 .. gestational diabetes is a form ofdiabetes that a woman develops only during pregnancy, and results in a higher likelihood of giving birth to a ba­ by much larger than average.104 a large baby is at risk of injury during birth.105 according to studies, women over the age of thirty-five are ap­ proximately twice as likely to suffer from gestational diabetes as younger women. 106 additionally, during pregnancy, the likelihood of a woman suf­ fering high blood pressure "is about double for women over [thirty-five] compared with younger women."107 another pregnancy-related danger that increases with age is placenta previa. placenta previa is a condition in which the placenta covers all or part of the cervix.108 women with this condition may hemorrhage during delivery, creating a danger for both mother and child.109 studies show that women in their forties· are approximately three times more likely to suffer placenta previa than younger women.110 the risk of placenta abruption, where "all or part of the placenta separates from the uterine wall," also in­ creases in women of advanced age.111 untreated placenta abruption can be life-threatening for both the mother and baby.112 placenta abruption causes the unborn baby to be deprived of oxygen and nutrients, which inay ulti­ mately lead to neurological or behavioral problems, and causes severe bleeding in the mother.m if the mother's bleeding cannot be controlled, a hysterectomy may be. necessary. 114 studies have also shown that the need for labor induction, the occur­ rence of "prolonged and dysfunctional labour," excessive bleeding during delivery, and breech or other malpresentations of the baby increase with advancing maternal age.115 a caesarean section may be necessary when there are problems associated with the placenta, such as placenta abruption or placenta previa, or when the mother is suffering from certain serious conditions like diabetes or high blood pressure.116 although many caesa­ rean sections are performed with no complications, there are risks asso­ ciated with this surgery. when compared with vaginal deliveries, studies 104. dimes, pregnancy after 35, supra note 69. 105. id. 106. id 107. mccarthy, supra note 16. 108. dimes, pregnancy after 35, supra note 69. 109. id 110. id. 111. mccarthy, supra note 16. 112. mayo clinic staff, placental abruption, mayoclinic.com, december 5, 2007, http://www.mayoclinic.comlhealtb/placental-abruption/ds00623 (last visited jan. 17, 2009). 113. ld 114. id 115. luke & brown, supra note 11, at 1264. 116. march of dimes, c-section: medical reasons, july 2008, http://www.marchofdimes.com/pnhec/240_1031.asp (last visited jan. 16; 2009) [hereinafter dimes, c.:.section]. . 290 indiana heal til law review [vol. 7:277 have shown that when the baby is in· normal position, the risk of complica­ tions and death of both the mother and her baby is twice as high when the baby is delivered via caesarean section.117 followi:i:l.g a caesarean section, women are at risk for increased bleeding, infection, bladder or bowel inju­ ries, and blood clots.118 although rare, death is also more likely to occur after a caesarean section than a vaginal delivery.119 further, women who have previously had a caesarean section and later become pregnant have a higher risk of developing placenta accreta, a condition in which the placenta implants into the uterine wall much too deeply and firtnly, or placenta pre­ via.120 while screening of embryos for genetic abnormalities is currently available, as discussed above, this screening does not prevent, or even re­ duce, these other pregnancy-related risks. iii. current state of regulation in the united states the use of arts and other infertility treatments remains largely unre­ gulated, at either the state or the federal level. at the federal level, there currently exists only the fertility clinic success rate and certification act of 1992 ("fcsrca").121 fcsrca was passed by congress in 1992, and "requires each medical center in the united states that performs art pro­ cedures to report data to cdc annually on every art procedure in­ itiated."122 this data is then used to determine the pregnancy success rates of the medical centers in the united states.123 the fcsrca also requires the secretary [of health and human services] to de­ velop a model program for the certification of embryo laboratories to be carried out by the states, to distri­ bute a description of the certification program to gov­ ernment officials of each state, and to encourage such officials to assist the state in adopting the program. 124 fcsrca neither mentions the age of a woman when it comes to access to 117. c-section raises risk to mother and infant, reuters, oct. 31, 2007, http://www.reuters.com/articlelhealthnews/idussatl7412420071 031 (last visited march 13, 2009). 118. dimes, c-section, supra note 116. 119. id. 120. id. 121. see fertility clinic success rate and certification act of 1992, 42 u.s.c.a § 263a-1 et seq. (west 1992). 122. wright et al., supra note 27. 123. wright et al., supra note 27. 124. sheri a. jayson, comment. "loving infertile couple seeks woman age 18-31 to help have baby. $6,500 plus expenses and a gift": should we regulate the use of as­ sisted reproductive technologies by older women?, 11 alb. l.j. sci. & tech. 287, 298 (2001). 2010] how old is too old? 291 fertility treatments, nor does it require that states adopt a certification pro­ gram. because the fcsrca .. does not require states to create or adopt a cer­ tification program, ... [a ]n individual state may choose to adopt such a program on a voluntary basis."125 unfortunately, state regulation is lacking, and instead, states largely choose to let the fertility industry regulate it­ self.126 a study conducted in 2005 showed that, "[ o ]n average, [21 0 of the then 369 fertility clinics] turn away only [four percent] of potential custom­ ers each year."127 of the responding clinics, "(o]nly [twenty-eight percent] had formal policies on who [these clinics would] accept or deny."128 not only do fertility clinics rarely enact formal policies, but the states may be hesitant to legislate in the area of arts due to the fact that the relevant science is not easily understood, defe­ rence to physicians and the recognition that the prac­ tice of medicine has been largely self-regulating, the queasiness with which reproductive and sexual issues are discussed, the fear of trampling constitutionally­ protected rights and the value of individual choice, and the ever-present political ramifications that tie this issue to that of abortion and the conservative right.129 for those states that do have legislation relating to access to infertility treatments, it is often aimed at insurance coverage. currently, twelve states require insurers to provide insurance coverage for the treatment and diagno­ sis of infertility.130 these states include arkansas, connecticut, hawaii, lllinois, maryland, massachusetts, montana, new jersey, new york, ohio, rhode island, and west virginia.131 two other states, california and tex­ as, require that insurers at least offer coverage for the treatment of infertili­ ty.132 many of these states' laws impose, or permit the imposition of, a maximum age limit on women covered, as well as other limitations. for example, connecticut's statute provides that the ''policy may ... limit such 125. id. 126. byers, supra note 65. 127. marilynn marchione, few fertility clinics have policies for deciding who to help get pregnant, survey shows, the associated press, jan. 19, 2005, available at http://www.aegis.org/news/ap/2005/ap050132.html (last visited jan. 31, 2010). 128. id. 129. susan b. apel, access to assisted reproductive technologies, 12 mich. st. u. l. j. men. & l. 33, 37 (2008) (citations omitted). 130. national conference of state legislatures, state laws related to insurance cov­ erage for infertility treatment, http://www.ncsl.orglprogramslhealth/50infert.htm (last vi­ sited march 13, 2009). 131. id 132. !d. 292 indiana health law review [vol. 7:277 coverage to an individual until the date of such individual's fortieth birth­ day."133 while these states require or permit the imposition of a maximum age limit on women for insurance coverage purposes, they do not require fertili­ ty clinics to impose a similar age restriction on women seeking access to infertility treatments. therefore, it is left up to each fertility clinic to de­ termine whether to impose a maximum age limitation. such self-regulation can lead to dangerous results for a post-menopausal woman willing to go to great lengths to have a child of her own. for example, such a woman faces exploitation in that a fertility specialist may not try to dissuade her from paying for and undergoing such a high-risk procedure where the likelihood of success is extremely low. such a woman is at risk for exploitation by fertility specialists in that the specialist may permit her to pay for and un­ dergo the a high-risk procedure when the likelihood of success is extremely low!34 a. indiana indiana currently lacks legislation requiring insurers to cover fertility treatments for certain age groups, but there has been at least one attempt to regulate some aspects of the fertility industry. from 2005 to 2006, indiana legislators introduced proposed legislation, which would in effect, "prohibit health care providers from offering and performing any medical procedure on an unmarried woman for the purpose of conception or procrea­ tion ... [this bill] ... would have required that couples who seek assis­ tance to become pregnant ... would have to be married to each other."135 while unmarried couples would be prohibited from utilizing infertility treatments in order to become pregnant, the bill made no references to a woman's age with regard to access. this bill also "required intended par­ ents to seek an assessment from a licensed child placing agency before any art services could begin."136 while this bill was ultimately dropped, it 133. conn. gen. stat. ann. § 38a-536 (west 2007). 134. see the ethics committee of the american society for reproductive medicine, fertility treatment when the prognosis is very poor or futile, 82 fertiuty & sterility 806 (2004), available at http://www.asrm.org/media/ethics/futility.pdf (last visited feb. 14, 2009) (discussing ethical recommendations for physicians facing maximum age limitation issues). the ethics committee considers as an example of "treatment plans likely to be fu­ tile are those in which couples try nf treatments with their own gametes when the female partner has ovarian failure or is over 50 years of age .... " id. at 807. in cases perceived to be ''futile" or those with a "very low prognosis," the ethics committee recommends that physicians fully inform patients of this fact and ''refuse to initiate or continue [fertility] treatment when they have a reasonable medical judgment that the given treatment option is futile .... " id. at 807-8. 135. judith f. daar, accessing reproductive technologies: invisible barriers, indelible harms, 23 berkeley j. genderl.18, 45 (2008). 136. apet, supra note 129, at 38; see ind. health finance comm., draft 2010] how old is too old? 293 has been indiana's only proposed legislation relating to access to infertility treatments. b. nongovernmental organizations in the area of reproductive technology, there are two notable nongo­ vernmental organizations that attempt to provide some guidance. these organizations are the american society for reproductive medicine ("asrm") and the society for assisted reproductive technology ("sart"). asrm is a non-profit organization that promulgates "recommenda­ tions regarding quality control for nf clinics."137 asrm publishes ethical guidelines and recommendations, as well as information regarding recom­ mended procedures; minimum standards to be used by fertility clinics; joint reports discussing current topics in the area written by asrm in collabora­ tion with other medical professionals; in addition to many other publica­ tions designed to educate its members and maintain a high standard of quality in the field. 138 asrm recommends, for example, that women who wish to donate eggs be between the ages of twenty-one and thirty-four. 139 asrm justifies its preference for egg donors to be younger than age thirty­ four by stating "that younger women typically respond favorably to ovula­ tion induction, produce more eggs and high-quality embryos with high im­ plantation and subsequent high pregnancy rates."140 membership in asrm is not mandatory, however, and compliance with the recommendations and guidelines is voluntary even for member fertility clinics.141 because it is not required for members to follow asrm's recommendations and guide­ lines, ''no enforcement mechanisms are in place to ensure compliance."142 thus, each clinic (or clinic administrator) can make the determination of how to maintain that particular clinic. sart is an "organization of professionals dedicated to the practice of assisted reproductive technologies ... in the united states. [sart] in­ cludes over 392 member practices, representing over [eighty-five percent] of the art clinics in [the united states]."143 membership in sart is also voluntary. the stated mission of sart "is to set and help maintain the (2005) (proposing additional section ic 31-9-2-9.5), available at htq>:l/www.in.gov/legislative/ interim/committeelprelim/hfc004.pdf(last visited jan. 17, 2009). 137. byers, supra note 65. 138. see asrm, third party reproduction, supra note 3. practice committee reports: guidelines, statements and opinions of the asrm practice committee, http://www.asrm.org/media/practice/practice.html (last visited feb. 14, 2009). 139. asrm, third party reproduction, supra note 13. 140. jd .. 141. byers, supra note 65. 142. byers, supra note 65. 143. society for assisted reproductive technology, what is sart?, http:// www.sart.org/whatissart.html (last visited jan. 9, 2009) [hereinafter sart, what is sart?]. 294 indiana health law review [vol. 7:277 standards for art."144 in addition, sart compiles and presents the suc­ cess rates of fertility treatments performed by cliriics located in the united states.145 sart participates in creating guidelines and minimum standards of care to be used in each clinic, and in order to become a member of this organization, clinics must comply with these guidelines and standards.146 sart recommends that women seeking to utilize arts using their own eggs be under the age of forty-four. 147 sart also recommends that women undergoing arts with the use of donor eggs be under the age of fifty.148 therefore, both asrm and sart show a preference for women utilizing arts to be under the age of fifty, and even younger in certain cases. iv. federal regulation is needed in tile united states a. why regulation is needed the examples of advanced-age child birth discussed in the introduc­ tion of this note showcase the extreme ways in which infertility treatments can be· put to use. the stories of these women represent the use of repro­ ductive technologies for reasons other than those for which it was in­ tended-to assist women of child-bearing age in reproduction. according to the cdc, women are considered "of reproductive age" from fifteen to forty-four years old.149 while the use of such technology can be successful in some women of advanced age, as illustrated in the previous examples, it does not follow that this technology should be used in such extreme ways. the reasons given by some of these women for choosing to undergo infer­ tility treatmentsa seventy-year-old mother and grandmother whose sole purpose was to have a son, 150 or a sixty-year-old mother of children aged six to thirty-three who wished to have a biological playmate for her young­ est son and to "remove the stigma" associated with advanced-age pregnan­ cieslsl~are hardly justifications for such extreme and irresponsible uses of these infertility treatments. while the few women that continue to owlate into their later years may chose to continue to have children, for whatever reasons, this should not be justification for the use of infertility treatments in• post-menopausal women. there can be no measure of control over the women that naturally continue to ovulate and maintain their ability to bear children. the same, however, is not true for post-menopausal women who 144. id 145. see sart, what is sart?, supra note 143. 146. id 147. society for assisted reproductive technology, art candidates, http://www.sart.org'guide_artcandidates.h1ml (last visited feb. 13, 1009). 148. id 149. wright et al., supra note 27. 150. caplan, supra note 8. 151. ap, n.j. woman, supra note 5. 2010] how old is too old? 295 then choose to reach out to infertility treatments in an effort to conceive. uniform federal regulation in the area of assisted reproduction is needed. the current system, consisting of leaving the regulation of infertili­ ty treatments up to the states and the individual fertility clinics, has proved insufficient. so long as this system is in use, there will always be some fer­ tility clinics that are willing to use arts in risky, extreme and radical ways, such as physicians permitting a seventy-year-old to engage in nf for the sole purpose of having a son. the safety and well-being of the women and of the unborn children are at issue. the increased risks to the mother and child caused by an advanced-age pregnancy provide strong justifications for the imposition of a maximum age limit on women seeking access to infertil­ ity treatments. it is one thing for women who have suffered premature me­ nopause, or for pre-menopausal women who, for genetic or other medical reasons, cannot conceive on their own to utilize infertility treatments to as­ sist in becoming pregnant. it is quite another situation for women beyond the age of menopause to take advantage of such technology in an attempt to conceive a child. permitting a post-menopausal woman to use arts is both unethical and irresponsible of the acquiescing physician. for a post-menopausal woman to have a child is selfish, and it is also unnatural. additionally, and perhaps most importantly, it is dangerous to both the woman and the unborn child. while there may be many healthy and active post-menopausal wom­ en, the statistics show that pregnancy alone is very risky for both the older woman and the child. even a seventy-year-old woman considered to be active and healthy with an uneventful pregnancy is highly likely to leave her baby orphaned, as .the average life expectancy as of 2006 is 77.7 years old.152 therefore, in the case of the seventy-year-old mother, her child will likely be orphaned at the age of seven or eight. the case of omkari panwar, discussed above in part i, exemplifies the selfish nature of post-menopausal women utilizing arts. the exploitation of fertility treatments in order to have a child of a certain sex is arguably both ethically and morally questionable at any age. but when the mother is seventy years old, as panwar was, and her sole purpose in achieving a preg­ nancy is so she may have. a boy, the utilization of art by post-menopausal women is both self-serving and unjustifiable. a woman should not be per­ mitted to expose a prospective child to the risk of down syndrome or other chromosomal anomalies as high as l in 11 and 1 in 8, respectively, for the sole purpose of having a child of a certain sex. 153 in addition to these high risks to the child, a woman of such advanced age puts herself at great risk. 152. national center for health statistics, u.s. department of health and human ser­ vices, centers for disease control and prevention, life expectancy, http://www.cdc.gov/ nchs/fastatsllifexpec.htm (last visited jan. 9, 2009). 153. mccarthy, supra note 16. 296 !ndianahealth law review [vol. 7:277 for instance, older women are much more likely to suffer from gestational diabetes and pregnancy-induced hypertension, as well as many severe risks during the delivery. 154 while cases such as those mentioned in this note may be extreme examples, as long as no uniform regulation exists, there will always be physicians at fertility clinics willing to allow their patients to utilize art in such controversial ways. in the case of frieda birnbaum, also discussed above in part i, birn­ baum's stated reasoning for wanting another child was so her son, age six at the time, .. would have siblings closer to his age," as her other two children were much older.155 birnbaum also stated as her reasoning for undergoing fertility treatments at the age of sixty that she ''warited to remove some of the stigma attached to older women giving birth."156 a woman putting her­ self and her unborn child through a high-risk pregnancy is self-serving, and it is unjustified by the sole reason of providing the mother's other children with a biological playmate close in age. such behavior fails to take into account the best interests of the unborn child. another selfish aspect of such examples is that at a young age most of these children will be left with either parents that are very old or parents that are deceased. in birnbaum's case, when her twins are just ten years old, she will be seventy years old. while birnbaum may be in good health at the age of sixty, it is not as likely that she will maintain a healthy state at the age of seventy. also, it will be very difficult for a seventy-year-old to take care of two ten-year-old children. especially troubling are the cases such as panwar's, as panwar will be eighty years old when her twins are only ten years old. it is highly likely that panwar's twins will be orphaned. in the event that these parents are still living, parents in their sixties, seven­ ties, and older, will will likely be incapable of being as involved with the child as a younger parent would be. these older parents will not have the energy necessary to keep up with a small child every day. it is unnatural for a post-menopausal woman to reproduce. once a woman undergoes menopause, she is no longer capable of reproducing on her own. with the exception of women who suffer premature menopause, post-menopausal women should not then be permitted to utilize infertility treatments in an attempt to override mother nature's limit on the ability to bear children. naturally, women's fertility begins to decline around the age of thirty, with a sharp decline occurring around the age of thirty-eight.157 this decline in fertility is accompanied by a decrease in egg quality. this appears to be nature's way oflimiting a woman's ability to conceive as she ages, and at a certain point, on average around the age of fifty-one, women stop ovulating all together. circumventing mother nature's limit on repro154. mccarthy, supra note 16. 155. ap, n.j. woman, supra note 5. 156. ap, n.j. woman, supra note 5. 157. see mccarthy, supra note 16. 2010] how old is too old? 297 duction is risky and frequently leads to problems for the mother, the child, or both. other fields dealing with reproduction and infertility have set age li­ mitations on women, and sometimes on both men and women. for exam­ ple, many adoption agencies throughout the united states have set age limits . on parents seeking to adopt. such agencies justify age restrictions "on the grounds that [parents above a certain age] would not have been like­ ly to produce such children themselves."158 therefore, while some may argue that government regulation does not belong in such intimate and pri­ vate decisions, age-related limitations on access already exist in similar areas. in any event, the united states supreme court has not held that a post-menopausal woman's right to access arts is a constitutionally pro­ tected fundamental interest. federal regulation imposing a maximum age beyond which a woman may no longer access infertility treatments is necessary. this maximum age limit should be set at the average age of menopause, age fifty-one. 159 the age of menopause will undoubtedly change over the years, and the maximum age limit should change along with it. while some. women may experience menopause at a later age (the range being, on average, age forty to fifty-five)/60 the vast majority of women will not. for those women who do experience menopause at a later age, they would not be prevented from naturally conceiving a child. given the high likelihood of complications and risks to both the mother and the child when women are forty-nine years old and older, and even as young as forty years old, the justifications for extending the maximum age limit to fifty-five or older are strongly out­ weighed by such risks. federal regulation of the fertility industry, as opposed to leaving it. to the individual states to regulate, would create a uniform rule that all fertility clinics throughout the united states would be required to follow. in addi­ tion, cryogenic technology allows a woman to freeze her eggs or embryos before reaching the cut-off age of fifty-one. in such cases, a fertility clinic shall not be permitted to then implant the thawed embryo, or to fertilize the thawed egg and implant it into a woman once she has reached the age of fifty-one. such age-related regulation is not taking away any right that women naturally would have otherwise, save the small percentage of women who will undergo menopause at an age later than fifty-one. in any event, women 158. naomi d. johnson, note, excess embryos: is embryo adoption a new solution or a temporary fix?, 68 brook. l. rev. 853, 873 (2003) (quoting elizabeth bartholet, family bonds: adoption and the politics of parenting 72 (1993)). 159. see opinion no. 413, supra note 15, at l. 160. see centers for disease control and prevention, women's reproductive health: menopause, http://www.cdc.gov/reproductivehealth//womensrhjmenopause.htm (last vi­ sited jan. 9, 2009). 298 indiana health law review [vol. 7:277 aged fifty years and older who have not yet undergone menopause only have five-tenths of a percent chance of conceiving.161 post-menopausal women have biologically lost the ability to reproduce, and no longer can they use their own eggs but must instead use donated eggs or embryos. additionally, as mentioned in part i.b., only one percent of women as young as forty-four who decide to use their own eggs in undergoing arts will achieve a live birth. 162 therefore, restricting access to the arts by women fifty-one years of age and older does not rob the majority of women of a chance at conceiving a child that they would have had but for an unan­ ticipated genetic condition, disease, or medical treatment. b. substantive due process framework the united states supreme court (the "court") recognizes a funda­ mental right to determine whether to bear a child. 163 as included in the right to privacy. to date, the court has not, however, recognized access to infer­ tility treatments as a constitutionally protected fundamental right. it has been suggested that "a fairly strong doctrinal case can be made for recog­ nizing access to ivf as a protected fundamental right [, and this] right ... would ... likely be framed ... as part and parcel of [the right to reproductive decision-making]."164 while it has been argued that infertility treatments may be an infertile individual's only hope of conceiving a child, 165 a post-menopausal woman is not considered to be "infertile."166 therefore, the court may not view the right of access to infertility treat­ ments by a post-menopausal woman the same as the right of access to infer­ tility treatments by an "infertile" woman. 1. · different levels of review the court utilizes three standards of review when called upon to de­ cide a challenge to a statute or other regulation based upon substantive due process grounds. these standards of review include: strict scrutiny review, intermediate review, and rational basis review. these three standards differ in the amount of deference given to the government's interests advanced in 161. jayson, supra note 124, at 303. 162. cdc, 2006 art report, supra note 26, at 27. 163. skinner v. state of oklahoma ex rei. williamson, 316 u.s. 535, 541 (1942). 164. note, assessing the viability of a substantive due process right to in vitro ferti­ lization, 118harv. l. rev. 2792, 2805-06 (2005) [hereinafter assessing the viability]. this note provides an in-depth discussion of substantive due process issues as they relate to access to ivf, broadly. 165. id. at 2805. 166. see supra part i.a. as discussed in part i.a., the term "infertile" is used to de­ scribe women of normal childbearing age. national institute of child health and human development, supra note 20. 2010] how old is too old? 299 support of the statute or other regulation. a. strict scrutiny in the event that access to fertility treatments is determined to be a fundamental right, a strict scrutiny standard of review may be used by the court should such regulation is challenged. a strict scrutiny standard of review provides that "a regulation found to burden a constitutionally pro­ tected fundamental right will only be upheld if it is 'narrowly tailored to serve a compelling [governmental] interest. "'167 it is difficult for a statute or regulation to overcome strict scrutiny, as this standard is the least defe­ rential to the government. b. intermediate scrutiny the court will, however, sometimes apply an intermediate scrutiny standard of review when dealing with cases involving a fundamental right.168 as the name suggests, this level of review is less deferential than strict scrutiny but more deferential than rational basis review. according to the intermediate scrutiny standard of review, when a regulation '"signifi­ cantly interferes with the exercise of a fundamental right, it cannot be upheld unless it is supported by sufficiently important [governmental] inter­ ests and is closely tailored to effectuate those interests. "'169 c. rational basis rational basis standard of review is the most deferential to the gov­ ernment. most statutes and regulations reviewed under this standard will be upheld. rational basis review provides that the challenged regulation must bear a rational relation to a legitimate governmental interest.170 d. which standard of review applies which standard of review is applied by the court in the event of a challenge to a regulation depends upon whether it is determined that a con­ stitutionally protected fundamental right exists as to access to infertility treatments by post-menopausal women. it is difficult to predict a court's 167. assessing the viability, supra note 164, at 2806 (citing reno v. flores, 507 u.s. 292, 302 (1977)). 168. !d. at 2807. 169. assessing the viability, supra note 164, at 2807 (citing zablocki v. redhail, 434 u.s. 374, 388 (1978)). 170. see, e.g., washington v. glucksberg, 521 u.s. 702 (1997) (applying the rational basis standard of review). 300 indiana health law review [vol. 7:277 determination on the specific issue of access to . infertility treatments by post-menopausal women. there appears to be a strong argument for recognizing a constitution­ ally protected fundamental interest in access to infertility. treatments by the "infertile."171 this argument, however, loses its force when the subject is a post-menopausal woman, as opposed to an infertile woman. therefore, while the court is more likely to recognize a constitutionally protected fun­ damental right of infertile women to access most infertility treatments with­ in their right to reproductive decision-making, it is less likely that the court will conclude the same when it comes to post-menopausal women. it is highly unlikely that the right of post-menopausal women to access infertility treatments is '"deeply rpoted. in this nation's history or tradi­ tions,"' m which the court has stated as a means of determining whether a fundamental right exists. because post-menopausal women could not, until recently with the advent of infertility treatments, conceive, their right to access such infertility treatments would not be considered "deeply rooted in this nation's history or traditions." while this argument appears to suggest that women of child-bearing age also lack a constitutionally protected fun­ damental right of access to infertility treatments due to the fact that access to such treatments is not "deeply rooted in this nation's history or tradi­ tion," it may be that the court will find such a right of access for these woman to be coextensive with another recognized fundamental right, such as the right to procreation.173 in that case, the right of access to infertility treatments itself would not need to be "deeply rooted in this nation's histo­ ry or traditions,'' because it would be considered part of a prior recognized fundamental right. therefore, the fact that strong arguments and justifica­ tions exist against recognizing a constitutionally protected fundamental right of access to infertility treatments by post-menopausal women, this does not necessarily preclude recognition of such a right for women of child-bearing age. · · · · if the court makes the determination that a co~titutionally protected fundamental right of access to infertility treatments by post-menopausal women exists, the court would then need to determine whether to. apply a strict scrutiny. standard of review or an intermediate scrutiny standard of review. if, instead, the court determines that a constitutionally protected fundamental right of access of infertility trea1:iq.ents by post-menopausal 171. see assessing the viability, supra note 164, at 2808 (concluding that. while diffi­ cult to predict the ultimate outcome, it is likely that the united states supreme court would recognize a fundamental right of access to ivf and would apply intermediate scrutiny to any regulation restricting access). ' 172. ld. at 2803; see also washington v. glucksberg, 521 u.s. 702 (1997) (setting out the test for determining substantive due process rights). 173. see assessing the viability, supra note 164, at 2803-04 (discussing the glucksberg . framework in determining whether a fundamental right exists as to access to ivf). 2010] how oid is too oid? 301 women does not exist. then the court would use the rational basis standard of review. once the level of review has been determined, the court will then look to the government's asserted interests in regulating access to infertility treatments and decide if those interests are related to and justify the restric­ tion to the degree required by the chosen level of review. as mentioned above in part iv.b.l.a., it is difficult for any regulation to pass a strict scru­ tiny standard of review, which requires that the regulation be narrowly tai­ lored to serve a compelling governmental interest. therefore, if strict scrutiny review is applied, it is likely that regulation restricting the access of post-menopausal women to infertility treatments will not be upheld, de­ pending upon the court's view of the government's interests and whether the regulation is narrowly tailored. if rational basis review is applied, it is highly likely such regulation will be upheld, so long as the asserted go­ vernmental interests are reasonable and are not arbitrary. it is more difficult to predict the outcome if intermediate scrutiny review is applied because it depends greatly upon the court's balancing of both the private interests and the governmental interests at stake. 2. governmental interests advanced by restricting access to infertility treatments based upon age the most important, and perhaps the most obvious, interest advanced by restricting access to infertility treatments by post-menopausal women is protecting the health of the woman and the child. as discussed throughout this note, there are many substantial risks facing women of advanced age who decide to undergo infertility treatments. for example, older women over the age of forty are twice as likely to suffer from gestational diabetes as younger women, are much more likely to experience high blood pressure during pregnancy, and suffer an increased rate of delivery-related complica­ tions as a woman ages, including severe and potentially life-threatening hemorrhaging. in addition to the risks facing older women, the unborn children are faced with significant risks. the unborn child faces a high likelihood of being born prematurely, which can lead to a variety of health problems, some of which are life-long. furthermore, the rate of stillbirth doubles for women in their forties as compared to women in their twenties. perhaps the most troublesome statistic is that at the age of forty-nine, a woman has a 1 in 11 chance of having a child afflicted with down syndrome and a 1 in 8 chance of having a child born with some other chromosomal anomaly.174 such risks coupled with the considerable decrease in the success of infertili174. see supra part ii. (discussing the risks to both the mother and the child associated with advanced-age pregnancies). 302 indiana health law review [vol. 7:277 ty treatments in women of advanced age, provide strong justifications for governmental interference in this area. the court is likely to view such a governmental interest in protecting women and unborn children from such extreme risks as at least an important, if not a compelling, governmental interest. additionally, "[t]he court has traditionally accorded great defe­ rence to ... regulations based on public health concerns ..... m another important governmental interest is protecting post­ menopausal women from being taken advantage of by fertility specialists.176 many women seeking the assistance of infertility treatments are desperate and willing to do and try anything to achieve their dreams of becoming mothers. this may be especially true with a woman past the age of meno­ pause, who may have put off child-bearing for a number of reasons and for whom infertility treatments are now her only hope to achieve pregnancy. in such situations, these women are likely to be emotionally and mentally fra­ gile and willing to believe that treatment will be successful in their case, no matter how unlikely. this situation creates the opportunity for exploitation of these women by physicians. because no uniform regulation exists that is aimed at setting a maximum age limit on women, and because infertility treatments are extremely expensive, 177 physicians may be inclined to pro­ vide such treatment even though the chances of success are incredibly low and the risks are high.178 as discussed previously in this note, the rate of miscarriage for women over the age of forty can be as high as fifty per175. assessing the viability, supra note 164, at 2810. 176. see assessing the viability, supra note 164, at 2810-11 (suggesting that "another strong state interest in regulating ivf is protecting the infertile from exploitation" regarding overall access to ivf). 177. see jayson, supra note 124, at 328-30 (discussing the costs associated with arts). as of the year 2001, a single cycle ofivf cost between $8,000 and $12,000. /d. during that same time, artificial insemination cost approximately $111 per visit and an additional $250 for the semen specimen. /d. medication used in connection with art procedures cost ap­ proximately $1,300 for an eight day supply, and art involving the use of a frozen embryo cost around $1,000. /d. additionally, the use of a donated egg, which is a requirement for a post-menopausal woman seeking to conceive, would cost anywhere from $13,000 to $25,000 per attempt. id the costs of these procedures add up quickly, as many women, particularly older women will require more than one cycle. 178. see judith f. daar, regulating reproductive technologies: pancea or paper tig­ er?, 34 hous. l. rev. 609 (1997)(discussing in part ll.a.3 informed consent issues sur­ rounding the use of art, including a discussion of the need for full disclosure of risks and chances of success, as well as the potential predatory practices of physicians). in her article, daar argues that: to the extent patients have shown a willingness to buy these [expensive] services ... , physicians have shown an equal desire to provide such ser­ vices despite outcome data that suggests a low probability of suc­ cess . . . . [p]hysicians have little or no incentive to counsel patients to stop treatment, because there may be a chance, albeit slight, that this pa­ tient will succeed. ld at631. 2010] how old is too old? 303 cent. 179even in the event that a post-menopausal woman is turned down at one clinic, she may simply go right to another clinic and find a physician willing to assist her in undergoing infertility treatments. 180 for a post-menopausal woman who has found a willing physician, predatory practices continue when the physician allows the woman to con­ tinue infertility treatments after one or more failed attempts.181 these women will incur crushing debt and are not likely to see the intended result, such as a successful full-term pregnancy. what these women are more like­ ly to experience, however, are the adverse risks associated with advanced­ age pregnancies. additionally, as discussed in part iii, some states permit insurance providers to impose maximum age limits on coverage for infertility treat­ ments. women over the age limit in these states are left to pay for their in­ fertility treatments out-of-pocket. for a physician at a fertility clinic to then proceed to treat a post-menopausal woman, knowing she is incurring great expense, that she very likely cannot afford, that her chances of achieving a successful pregnancy are very low, and that her and her child's risks of se­ vere complications are high, would be unethical. the government has a strong interest in protecting these women from such predatory practices. v. conclusion in conclusion, the substantial likelihood of health risks to both women and children associated with advanced-age pregnancies, coupled with the potentially predatory actions of physicians justify the imposition of a max­ imum age limit on women seeking access to infertility treatments. the government has a strong interest in protecting these woman and their un­ born children from the high risk of adverse health consequences associated with such advanced-age pregnancies. furthermore, the government has a strong interest in protecting post-menopausal women from predatory prac­ tices of physicians willing to treat these women despite the high risks to the health of the woman and her child, the unlikelihood of a successful full­ term pregnancy, and the high cost of such treatments. should such regulation be imposed, a substantive due process chal­ lenge would likely arise. as discussed above in part iv.b. of this note, even if the court finds that access to infertility treatments is a constitution179. byers, supra note 65. 180. see the ethics committee of the american society for reproductive medicine, fertility treatment when the prognosis is very poor or futile, 82 fertility & sterility 806 (2004), available at http://www.asrm.org/media/ethics/futi1ity.pdf (last visited feb. 14, 2009). 181. lliescu, whose story was discussed supra part i. introduction, had undergone nine years of unsuccessful fertility treatments before finally conceiving and giving birth to her daughter at the age of sixty-six. see ap, romanian woman, supra note 1. 304 indiana realm law review [vol. 7:277 . . . ally pro~cted fundamental right, i~ is unlikely that such a fundamental right would be found to exist as to post-menopausal women. if a fundamental right to access is found to exist even for post-menopausal women, the court will apply either a strict scrutiny standard of review, or an intermediate scrutiny standard of review. in light of the strong interests advanced by regulation imposing a maximum age limit on access to infertility treatments by post-menopausal women, as discussed above in part n .b.2, it is likely that the court will defer to such interests and uphold. the limited regulation. l'h:e government should protect these interests of its citizens, and it should not be ·left up to individual fertility clinics to determine their own standards when such practice has proved to be inadequate. controlling health care spending: more patient “skin in the game?” david orentlicher1 i. introduction................................................................ 348 ii. the high costs of health care ................................ 350 iii. improving the return on our health care dollar ....................................................... 352 a. increasing patient “skin in the game” .................... 352 1. higher cost-sharing for lower-value care .......... 355 2. “reference pricing” ................................................. 356 3. “scaled cost-sharing” ............................................ 356 b. limits of cost containment ...................................... 357 iv. employer wellness programs ................................. 357 v. conclusion ................................................................. 362 i. introduction while health care cost inflation slowed during the past few years, it has started to pick up again,2 and policy makers have good cause for concern about future increases in health care spending. moreover, even if future increases moderate, policy makers rightly worry about the already high levels of u.s. spending. the need for effective cost containment strategies in health care persists, even though the affordable care act appears to have had some success at containing health care costs. health care spending reforms can focus on physician and hospital practices or on patient behavior, and popular reform 1 samuel r. rosen professor and co-director, hall center for law and health, indiana university robert h. mckinney school of law. md, jd, harvard university. i am grateful for the excellent editing of the indiana health law review. 2 drew altman, new evidence health spending is growing faster again, wall st. j. (june 11, 2015, 3:14 pm), http://blogs.wsj.com/ washwire/2015/06/11/new-evidence-health-spending-is-growing-fasteragain/ [perma.cc/d2yc-ybnq]. http://dx.doi.org/10.18060/3911.0019 2016 349 controlling health care spending: more patient “skin in the game?” proposals include both approaches. for example, rather than paying physicians and hospitals in terms of the quantity of care that they provide and encouraging the provision of too much care, private insurers and government programs are turning more and more to forms of reimbursement that are based on the quality of care delivered. insurers often adjust physicians’ compensation based on whether they screen their patients for cancer or high cholesterol, administer recommended immunizations, or achieve good control of blood sugar levels for their patients with diabetes.3 the affordable care act addresses patient behavior by requiring insurers to cover important kinds of preventive care for free.4 that way, people will not be discouraged for financial reasons from seeking early care that can keep them healthier and avoid the need for hospitalizations and other expensive treatments. in this article, i consider an increasingly common strategy that insurers use to influence patient behavior—giving people more “skin in the game.” when medical treatment can be obtained at very low cost, people may be too quick to seek it when they feel sick, visiting their physicians when they would do just as well by staying home. hence, insurers have raised deductibles5 and co-payments6 and shifted the costs of care to patients in other ways7 in the hope that people will 3 aparna higgins, german veselovskiy & lauren mckown, provider performance measures in private and public programs: achieving meaningful alignment with flexibility to innovate, 32 health aff. 1453, 1456-57 (2013). 4 see patient protection and affordable care act, pub. l. no. 111148, 124 stat. 119 (2010) (codified as amended at 42 u.s.c. § 18001 et. seq. (2010)). 5 a deductible refers to the costs of care that the patient pays before insurance kicks in. if the deductible is $500, the patient pays the first $500 in health care costs for the year. 6 a co-payment refers to the patient’s share of costs when care is provided. for example, a visit to the doctor’s office may come with a copay of $25, with the insurance company picking up the remainder of the physician’s fees for the visit. co-payments are similar to co-insurance, under which patients pay a percentage of the costs of care, say twenty percent of the costs of a hospitalization. 7 insurers also shift more costs to patients by raising the annual cap on the patient’s share of their health care costs from deductibles, copayments, and co-insurance (the cap on total out-of-pocket spending), as http://dx.doi.org/10.1377/hlthaff.2013.0007 350 indiana health law review vol. 13:2 become more conscious of the costs of their care. although concerns about patients seeking too much care are important, common strategies for giving patients more skin in the game have been poorly conceived. there is room for skin-in-thegame strategies to contain high health care spending, but only when they are properly designed. ii. the high costs of health care health care spending in the united states is approaching 18% of gross domestic product (“gdp”), a level well above other economically-advanced democracies.8 countries such as canada, germany, switzerland, and japan spend only about 10 to 11% of gdp on health care.9 and current u.s. spending is very high when compared with past u.s. expenditures. in 1980, health care spending accounted for only 9% of gdp.10 to some extent, higher spending makes sense. the united states is a rich country and therefore can afford to spend more on health care than many other countries. it is probably better for a country to spend its plentiful resources on health care than on yachts or tickets to professional football games. but do americans get enough bang for their extra health care bucks? concerns about health care spending are focused not only on the amount of spending but also on the fact that the united states does not appear to get sufficient benefit for all of its extra spending. on many health status metrics, the united states lags other countries. for example, life expectancy in the united states trails that of a wide range of countries, not only including canada, germany, switzerland, well as by providing less coverage for care received from physicians or hospitals that are not in the insurance company’s network (“out-ofnetwork” care). 8 oecd, health at a glance 2013: oecd indicators 157 (oecd publishing, 2013), available at http://www.oecd.org/els/health-systems/ health-at-a-glance-2013.pdf [https://perma.cc/kaf2-gpe7]. 9 id. 10 snapshots: health care spending in the united states & selected oecd countries, kaiser family found. (april 12, 2011), http://kff.org/ health-costs/issue-brief/snapshots-health-care-spending-in-the-unitedstates-selected-oecd-countries/ [https://perma.cc/a4kl-gtxa]. 2016 351 controlling health care spending: more patient “skin in the game?” and japan, but also italy, spain, greece, and the united kingdom.11 of course, many factors other than health care affect life expectancy and other measures of health. people in italy, spain, and greece may live longer because they consume a mediterranean diet.12 perhaps our higher health care spending helps narrow the gap between the united states and other countries even if it does not eliminate the gap. indeed, some data suggest that americans do get value for their health care dollar. for example, five-year breast cancer survival rates are higher in the united states than in canada, germany, japan, and the united kingdom.13 similarly, five-year colon cancer survival rates are higher in the united states than in canada, germany, and the united kingdom, though lower than in japan.14 and empirical data indicate that greater spending on cancer care contributes to the higher survival rates. in a study that considered the benefits and costs of cancer care in the united states and europe, researchers found that the survival gains from the extra spending on cancer in the united states exceeded the costs of the care.15 in another study, researchers found that reductions in deaths from cancer were greatest in countries where cancer care spending rose the most between 1995 and 2007.16 but other data indicate that we spend our health care dollars inefficiently. for example, asthma hospitalization rates are much higher in the united states than in canada, 11 oecd, supra note 8, at 25. infant mortality rates also are better in many other countries, including japan, portugal, spain, greece, france, poland, and the united kingdom. id. at 37. 12 francesco sofi et al., accruing evidence on benefits of adherence to the mediterranean diet on health: an updated systematic review and meta-analysis, 92 am. j. clinical nutrition 1189 (2010). 13 oecd, supra note 8, at 127. 14 id. at 129. 15 tomas philipson et al., an analysis of whether higher health care spending in the united states versus europe is 'worth it' in the case of cancer, 31 health aff. 667, 670-71 (2012) (assuming that an extra year of life has an economic value of $150,000 and comparing the economic value from the increased life expectancy to the costs of care). 16 warren stevens et al., cancer mortality reductions were greatest among countries where cancer care spending rose the most, 1995−2007, 34 health aff. 562 (2015). http://dx.doi.org/10.3945/ajcn.2010.29673 http://dx.doi.org/10.1377/hlthaff.2011.1298 http://dx.doi.org/10.1377/hlthaff.2014.0634 352 indiana health law review vol. 13:2 france, japan, and the united kingdom, and hospitalization rates for diabetes are much higher than in canada, spain, italy, and the united kingdom.17 if health care did more in the united states to maintain the health of people with asthma or diabetes, hospitalization rates would look more like those in other countries. and a study that estimated the efficiency of health care systems by comparing health care spending with health status of a country’s residents found that the united states trailed a wide range of countries, from canada, france, germany, italy, and the united kingdom to mexico, colombia, venezuela, and china.18 there also are domestic data suggesting that much health care spending is wasted. u.s. patients treated in high-cost communities are no healthier than patients treated in lowcost communities.19 indeed, patients actually might fare better in lower-spending areas.20 iii. improving the return on our health care dollar there are many ways to improve the efficiency of health care spending. if fee-for-service reimbursement encourages physicians to perform too many surgical procedures, it makes sense to rely more on salary-based compensation. or a percentage of physicians’ compensation could be based on the extent to which they meet quality-related targets for the health care they provide. for example, physicians would be paid more if more of their patients receive an annual influenza vaccine. a. increasing patient “skin in the game” should we also try to improve the efficiency of health care spending by giving patients more “skin in the game?” if patients had to pay a higher percentage of their health care 17 oecd, supra note 8, at 109. 18 david b. evans et al., comparative efficiency of national health systems: cross national econometric analysis, 323 bmj 307, 308-09 (2001). 19 elliott s. fisher, julie p. bynum & jonathan s. skinner, slowing the growth of health care costs—lessons from regional variation, 360 new eng. j. med. 849, 850 (2009). 20 id. http://dx.doi.org/10.1136/bmj.323.7308.307 http://dx.doi.org/10.1056/nejmp0809794 2016 353 controlling health care spending: more patient “skin in the game?” costs, would people be more likely to refrain from seeking care when they really do not need a doctor’s attention? more importantly, would people take better care of themselves if they had to pay more for their medical treatments? perhaps, americans would be healthier, and health costs would be lower, if people were more sensitive to the costs of the care that they receive. by its very nature, health care insurance dulls patient sensitivity to the costs of care. assume, for example, that a particular treatment costs $100 and provides a value to the patient worth only $75. if the patient were paying the full cost of care, the treatment would be declined. but if insurance covers most of the costs of the care, so the patient would face a co-payment of only $25, the patient would likely choose the care. getting $75 of value for $25 is a good deal.21 as long as we have health care insurance, patients will not be fully sensitive to the costs of their health care. but cost sensitivity is not an all-or-nothing phenomenon. even if we cannot make patients fully sensitive to the costs of their care,22 we have to decide on the level of sensitivity. if health care coverage is too generous, people may seek too much care, wasting health care resources. if health care coverage is not generous enough, people may not seek enough care, to the detriment of their health. many employers, insurers, and analysts think that patients have been insufficiently sensitive to the costs of their care.23 hence, in recent years, we have seen marked increases in the size of deductibles and co-payments to make patients more sensitive to health care costs.24 indeed, among employee health care plans, the average deductible for individual coverage more than doubled between 2006 and 21 see david orentlicher, cost containment and the patient protection and affordable care act, 6 fla. int’l u. l. rev. 67, 71 (2010). 22 nor would we want them to be. an important reason for having health care coverage is to ensure that people can have good access to health care even when they have limited financial resources. 23 see, e.g., james w. henderson, health economics and policy 8 (6th ed. 2014) (“fully-insured patients have no incentive to limit their utilization [of health care].”). 24 higher deductibles and co-payments also offer a way to limit increases in health care insurance premiums. 354 indiana health law review vol. 13:2 2014, and the percentage of individual plans with deductibles of $1,000 or more nearly quadrupled.25 is this a good trend? if the goal is simply containing costs, then giving patients more skin in the game may be useful. raising the patient’s share of health care costs through deductibles, co-payments and other out-of-pocket costs reduces patient demand for care. in the rand health insurance experiment, in which participants were randomly assigned to health care plans with different levels of cost-sharing, researchers found that higher cost-sharing led to fewer physician visits, fewer prescriptions, and fewer hospitalizations.26 but the reductions in financial costs may come with increases in non-financial costs. in particular, when patients refrain from seeking care because of the costs of care, their health may suffer. several studies indicate that when patients reduce their demand for care because of costs, they many not distinguish between needed and unneeded care. in the rand study, for example, there was no adverse impact on health for the average person.27 however, for poor individuals with medical problems, those with free care had better health measures and lower predicted mortality rates than their counterparts who were discouraged from seeking care by their deductibles or co-payments.28 in another study, which involved emergency department care, researchers again found that increased cost-sharing had an adverse effect on health for the poor.29 higher-income individuals in high-deductible plans reduced their emergency department visits only for “low-severity” services—services that were not urgent and could be provided at a clinic or doctor’s office at a later date.30 but, low-income persons 25 kaiser family found. & health research & educ. trust, employer health benefits: 2014 annual survey 125-26 (2014), available at http://files.kff.org/attachment/2014-employer-healthbenefits-survey-full-report [https://perma.cc/hd8u-y8gs]. 26 joseph p. newhouse & the ins. experiment grp., free for all?: lessons from the rand health insurance experiment 338 (1993). 27 id. at 338-39. 28 id. at 339. 29 j. frank wharam et al., low-socioeconomic-status enrollees in high-deductible plans reduced high-severity emergency care, 32 health aff. 1398 (2013). 30 id at 1399. http://dx.doi.org/10.1377/hlthaff.2012.1426 2016 355 controlling health care spending: more patient “skin in the game?” reduced visits for both “low-severity” services and the kinds of “high-severity” services that should be treated urgently in an emergency department.31 or consider a study that analyzed the impact of a new deductible and co-payments for prescription drugs.32 the increases in out-of-pocket costs led low-income persons to reduce their use of both low-value and high-value drugs, and accompanying the reduction in drug use, there was an increase in “serious adverse events” (hospitalizations, nursing home admissions, and deaths).33 while broad increases in patient cost-sharing seem illadvised because of their adverse effects on patient health, might more targeted increases be useful? recall in this regard that in the rand study, greater cost-sharing for the average person led to a reduction in health care spending with no harm to health.34 a few possibilities for targeted cost-sharing come to mind. 1. higher cost-sharing for lower-value care if the goal of patient skin in the game is to discourage unnecessary care while preserving desirable care, then it makes sense to reserve higher cost-sharing for lower-value care. the affordable care act’s requirement of free preventive care is a good model for this approach.35 we want people to receive effective preventive care—a high value kind of care—so the affordable care act prohibits the imposition of any fees on people when they obtain the care. similarly, to encourage the use of generic rather than more expensive brand-name versions of the same drug, insurers often require higher co-payments for brand-name drugs. as a general matter, heath care policy should remove obstacles to desired behavior while erecting obstacles to undesired behavior. 31 id at 1403. 32 robyn tamblyn et al., adverse events associated with prescription drug cost-sharing among elderly and poor persons, 285 jama 421, 421 (2001). 33 id. 34 joseph p. newhouse & the ins. experiment grp., supra note 26. 35 see patient protection and affordable care act, pub. l. no. 111148, 124 stat. 119 (2010) (codified as amended at 42 u.s.c. § 18001 et. seq. (2010)). http://dx.doi.org/10.1001/jama.285.4.421 356 indiana health law review vol. 13:2 2. “reference pricing” the high cost problem is not only a problem of patients receiving unnecessary care; it also is a problem of patients receiving necessary care at excessive prices. hip replacement surgery might cost $40,000 at one hospital and $80,000 at another hospital with no difference in quality (or possibly lower quality at the higher price). accordingly, some insurers will reimburse for surgical procedures only at a fixed “reference” price that reflects the fees charged by low-cost, high-quality physicians and hospitals.36 if a patient chooses a more expensive provider of care, the patient is responsible for the difference between the provider’s fees and the reference price. data on reference-pricing indicate that it leads patients to switch to lower-cost providers.37 it also causes higher-cost providers to lower their fees.38 3. “scaled cost-sharing” the degree to which patients are sensitive to the costs of their care depends on their income and wealth.39 a deductible of $1,000 represents 5% of income for a family earning $20,000, but only 0.5% of income for a family earning $200,000. or when annual caps on out-of-pocket spending are set at $6,000, they represent 30% of income for a family earning $20,000 but only 3% of income for a family earning $200,000. hence, standard policies for out-of-pocket costs will likely have a bigger impact on the care-seeking behavior of lower income persons. and as suggested by the previouslydiscussed studies on the health effects of cost-sharing, lowerincome persons may be overly discouraged from seeking care by standard cost-sharing policies. accordingly, rather than 36 james c. robinson & timothy t. brown, increases in consumer cost sharing redirect patient volumes and reduce hospital prices for orthopedic surgery, 32 health aff. 1392, 1392-93 (2013). 37 id. at 1394-95. 38 id. 39 christopher t. robertson, scaling cost-sharing to wages: how employers can reduce health spending and provide greater economic security, 14 yale j. health pol’y l. & ethics 239, 244 (2014). http://dx.doi.org/10.1377/hlthaff.2013.0188 2016 357 controlling health care spending: more patient “skin in the game?” setting cost-sharing levels at fixed dollar amounts, insurers could calculate deductibles, annual caps, and other forms of cost-sharing as a percentage of income.40 deductibles could be set at 1% of income, and annual caps could be set at 5% of income. b. limits of cost containment while carefully-designed health insurance reforms can play a significant role in making patients more conscious of costs, these reforms can play only a limited role in cost containment. the impact of cost-sharing strategies dissipates when patients hit their annual cost-sharing maximums. once a deductible is satisfied, for example, it no longer can have any influence, and once annual caps on total out-of-pocket expenses are exceeded, patients no longer need to worry about other cost-sharing policies such as copayments. reference pricing would still matter even after annual caps on out-of-pocket spending are satisfied, but estimates indicate that reference pricing would reduce overall spending by less than two percent.41 in sum, it is useful to consider health insurance reforms that encourage greater cost-consciousness among patients, but policy makers will have to look elsewhere for major savings in health care spending. might other patient-directed policies be useful? this article has focused so far on insurance plan design, but there are ways to influence patient behavior. the next section considers the potential role of employer wellness programs in containing health care costs. iv. employer wellness programs in addition to lowering health care spending by sending patients higher bills for their visits to the doctor or the 40 id. 41 paul fronstin & m. christopher roebuck, reference pricing for health care services: a new twist on the defined contribution concept in employment-based health benefits 10 (employee benefit research institute 2014), available at http:// www.ebri.org/pdf/briefspdf/ebri_ib_398_apr14.refprcng.pdf [https:// perma.cc/26pw-y3ua]. 358 indiana health law review vol. 13:2 hospital, we might lower spending by encouraging patients to take better care of themselves. if people are healthier, they will not need as many appointments with their doctors or admissions to the hospital. employers are increasingly using the skin-in-the-game approach to promote healthier behavior. through financial incentives tied to “wellness programs,” the hope is that employees will eat more nutritiously, exercise more regularly, and require less health care.42 wellness programs typically are divided into (1) screening initiatives and (2) intervention activities.43 screening initiatives include questionnaires that ask individuals about their diet, exercise, and other health-related matters.44 screening also can include clinical measurements such as a person’s weight, blood sugar, cholesterol, and blood pressure.45 if people realize that their weight, blood pressure, or other measurements are too high, they can follow up with a physician to see what kinds of action would be helpful. or they might follow up with the wellness program’s intervention activities. these can include counseling about exercise and diet, smoking cessation programs, gym memberships, and healthy food offerings in cafeterias or vending machines.46 while many employers simply offer their wellness programs alone, other employers combine the programs with financial incentives, sometimes rewarding employees for participation in the programs, at other times rewarding employees for improvement in their weight, blood pressure, 42 wellness programs can be implemented outside of the workplace. governments, insurers, and individuals for themselves also can design wellness programs. kristin m. madison, kevin g. volpp & scott d. halpern, the law, policy & ethics of employers’ use of financial incentives to improve health, 39 j.l. med. & ethics 450, 450-51 (2011). but there are important advantages to employment-based programs, in large part because people spend much of their waking time at their workplace. id. at 455. 43 david orentlicher, health care reform and efforts to encourage healthy choices by individuals, 92 n.c. l. rev. 1637, 1648 (2014). 44 id. 45 id. 46 id. http://dx.doi.org/10.1111/j.1748-720x.2011.00614.x 2016 359 controlling health care spending: more patient “skin in the game?” or other measures of health.47 under federal law, there is no limit on the magnitude of incentives that can be used to encourage employees to participate in wellness programs.48 while a typical incentive might provide employees with a rebate on their health insurance premiums of $100 or $200 for checks of weight, blood pressure, blood sugar, and cholesterol, an employer could offer much higher rebates for participation—or impose surcharges of any amount for nonparticipation.49 employers also might want to link their financial rewards or penalties to results. for example, a rebate or surcharge on insurance premiums might be tied to the losing of weight, the reduction of blood pressure, or the achievement of other health targets. for incentives tied to the satisfaction of health targets, the incentive may not be any higher than 30% of the cost of the employee’s health insurance coverage (with a 50% maximum for meeting smoking cessation targets).50 while wellness programs are sound in principle—an ounce of prevention is worth a pound of cure—there are significant problems with these programs in practice. for example, employers often do not choose effective programs.51 and even when wellness programs are successful, their results are modest. in one study, only one-third of employees lost at least five percent of weight.52 in another study, 47 id. at 1648-49. 48 id. (provisions regarding financial incentives for wellness programs are included in hipaa and aca.). 49 id. 50 id. at 1649. to protect employees from unfair discrimination, employers must offer reasonable alternative standards. for example, if the incentive is tied to weight loss, and a worker has a genetic disease that makes it very difficult to lose weight, the employer would have to revise the target for the employee. see id. 51 karen chan osilla et al., systematic review of the impact of worksite wellness programs, 18 am. j. managed care e68, e78 (2012) (finding positive outcomes only one half of the time for wellness programs that were studied with a randomized controlled trial). 52 caryn zinn et al., a “small-changes” workplace weight loss and maintenance program: examination of weight and health outcomes, 54 j. occupational & envtl. med. 1230, 1234-35 (2012). http://dx.doi.org/10.1097/jom.0b013e3182440ac2 360 indiana health law review vol. 13:2 participants lost less than one percent of weight on average.53 and these modest results may be exaggerated. when programs are voluntary, “selection bias” may exaggerate their effectiveness.54 hence, randomized controlled studies of wellness programs find smaller impacts than do nonrandomized studies. in one review of wellness program studies, researchers found that exercise programs generated positive results 62% of the time, but only 43% of the time when the studies involved a randomized control group for comparison.55 unfortunately, experts have not yet figured out how to design wellness programs that reliably deliver a high level of effectiveness. ineffective programs are not only wasteful, they also can be harmful. in one of its most important provisions, the aca promotes access to health care coverage by eliminating insurance premium surcharges for people with cancer, diabetes, heart disease, or other “pre-existing” medical conditions.56 no longer does a person’s health status affect the ability to afford health care coverage. but financial incentives tied to losing weight, lowering blood pressure, reducing blood sugar, or meeting other health targets will impose greater costs on persons with health problems, thereby undermining aca’s protection of persons with preexisting medical conditions. indeed, an analysis of employer wellness programs suggests that savings on health care spending from the programs may simply reflect the shifting of costs to employees with higher risks of illness.57 aca’s goal of affordable health care is further undermined by the fact that when person with health problems bear greater costs, the greater costs fall disproportionately on persons who are poor. 53 susan b. racette et al., worksite opportunities for wellness (wow): effects on cardiovascular disease risk factors after 1 year, 49 preventive med. 108, 110 tbl. 2 (2009). 54 selection bias refers to the possibility that a voluntary program will attract especially motivated participants whose experiences will be different from the people who choose not to participate in the program. 55 osilla et al., supra note 51, at e69. 56 see 42 u.s.c. § 300gg–4(a) (2016). 57 jill r. horwitz, brenna d. kelly & john e. dinardo, wellness incentives in the workplace: cost savings through cost shifting to unhealthy workers, 32 health aff. 468, 469 (2013). http://dx.doi.org/10.1016/j.ypmed.2009.06.022 http://dx.doi.org/10.1377/hlthaff.2012.0683 2016 361 controlling health care spending: more patient “skin in the game?” while financial incentives tied to wellness programs often are ineffective and even harmful, there are some wellness incentives that can be useful. a number of features are important: when incentives are tied to short-term progress, they seem to work better than incentives calculated on an annual basis. people respond more readily to immediate rewards and penalties than to delayed rewards and penalties.58 thus, in one study of financial incentives for weight loss, participants received lottery tickets or accumulated “deposit contract” rewards on a daily basis if they met their weight loss goals,59 and the incentives were effective at encouraging weight loss during the four months of the study.60 as this study also suggested, incentives may need to be maintained indefinitely. within several months after the study ended, there was no significant difference in weight loss between the participants and a control group of people who had not received the financial incentives.61 of course, this may simply reflect the fact that any strategies for weight loss need to be continued indefinitely, just as treatments for high blood pressure, diabetes, and other chronic medical conditions need to be continued indefinitely. finally, program designers need to consider whether their incentives should be implemented as penalties for failure or rewards for success. penalties often are more effective than rewards at eliciting changes in behavior. people worry more about losing something they already have than about gaining something they do not have.62 on the other hand, people 58 orentlicher, supra note 43, at 1643, 1652. 59 kevin g. volpp et al., financial incentive-based approaches for weight loss: a randomized trial, 300 jama 2631, 2632-33 (2008) (describing a study with deposit contracts where participants committed a small amount of money each day that was matched at a higher amount by the study, with the total dollars paid to participants who achieved their weight loss goals). while deposit contract awards could be earned on a daily basis, the awards were actually paid out on a monthly basis. id. at 2632. 60 id. at 2634-35. 61 id. at 2635. 62 scott d. halpern et al., randomized trial of four financialincentive programs for smoking cessation, 372 new eng. j. med. 2108, 2109 (2015). http://dx.doi.org/10.1001/jama.2008.804 http://dx.doi.org/10.1056/nejmoa1414293 362 indiana health law review vol. 13:2 prefer to be rewarded for success than penalized for failure, so reward-based incentives may be a more effective strategy overall.63 v. conclusion in recent years, concerns about health care cost containment have led employers, insurers, and governments to give individuals more skin in their health care game. but the interest in patient incentives for cost consciousness has exceeded the benefits that these incentives can deliver. when used in a limited and properly designed fashion, the incentives can achieve some cost savings. but the overall savings will be small, and they can easily be offset by their own costs if the incentives are not well-designed. 63 id. at 2114. roy g. spece, jr. roy g. spece, jr. graduated first in his class at the university of southern california law school and then practiced at the national law firm, gibson, dunn & crutcher for three years before becoming a law professor. he teaches law & bioethics, law & medicine, health law, and constitutional law at the university of arizona's lames e. rogers college of law. he has published books and numerous book chapters and articles in his teaching areas, especially focusing on constitutional, policy, and ethical analysis of problems raised in the health law field and by advances in biomedical technology. he is a fellow of the american trial lawyers association and has served as an expert consultant to federal and state governmental bodies, legal publishers, health care providers, attorneys, and law firms. he is a former president of the university of arizona faculty association and has been a member of his university's faculty senate, academic procedures and policies committee, human subjects committee, biohazards committee, and research policy committee. john j. marehalollis john j. marchalonis, professor ofmicrobiology and immunology at the university of arizona; ph.d., rockefeller university and a.b., phi beta kappa, summa cum laude, lafayette college. dr. marchalonis has been the recipient of numerous honors and awards. notably, he was the frank r. lillie fellow of the marine biological laboratory, woods hole, massachusetts (1973); mclaughlin fund lecturer, university of texas medical branch, galveston (1979); listed among the 1,000 contemporary scientists most cited 1965-1978 by current contents, to name a few of his many honors. dr. marchalonis has authored or co-authored more than 350 full-length scientific papers, eight books, and two patents. he is recognized internationally for contributions to molecular immunology and mechanisms of immune interactions, molecular evolution of innate and adaptive immunity, and innovative developments in protein and peptide chemistry. peptide and human monoclonal antibody approaches pioneered by dr. machalonis and his colleagues have led to novel contributions to cancer (melanoma, lymphoma, and myeloma), autoimmune diseases (rheumatoid arthritis and systemic lupus erythermatosis), alzheimer's disease, and aids. sound constitutional analysis, moral principle, and wise policy judgment require a clear and convincing evidence standard of proof in physician disciplinary proceedings roy g. spece, jr.* john j. marchalonis·· introduction medical boards license and discipline physicians pursuant to statutory authority in each state. 1 the precise structure and function of these boards varies although the vast majority of them share certain characteristics: ( 1) they include non-physician members but are dominated by physicians; (2) they frequently combine investigative, prosecutorial, and judicial duties; (3) their decisions are subject to judicial review under a very deferential standard; and ( 4) they can apply an array of sanctions upon a finding of "unprofessional conduct."2 the definition ofunprofessional conduct differs from state~to­ state. it commonly includes criminal activity that relates to professional attributes, incompetence, impairment from drugs or alcohol, and gross negligence.3 scholars' observations about medical boards ventured over a decade ago remain true today: given the importance of[ their] tasks, it is surprising that very little is known about how well boards are able to perform them. most discussions about the effectiveness of medical boards have been based on counts of disciplinary actions (e.g., number of revocations, suspensions and probations imposed per one thousand physicians), which do not give us a full picture ofboard activity. very little is known about who complains to medical boards, how allegations of incompetence or unprofessional conduct are investigated, and * professor, university of arizona, james e. rogers college of law. ** professor, department of microbiology and immunology, cojlege of medicine, university of arizona. 1. timothy jost et al., consumers, complaints, and professional discipline: a look at medical licensure boards, 3 health matrix 309, 309-10 (1993). 2. barryr. furrowet al.,healrnlaw §§ 3-18 (combination of functions); 3-19 & 3-23 (limited judicial review); 3-22 & 3-25 (grounds for discipline & domination by professionals). 3. id. at§§ 3-22 & 3-25. 108 indiana health law review [vol. 3:103 how boards react once a problem has been confirmed.• this article examines a single but central element of medical board proceedings: the standard of proof. it concludes that although approximately three-fourths of the states employ a prepondetan:ce of the evidence standard,5 sound constitutional analysis, moral principle, and wise policy judgment support the use of a clear and convincing evidence standard. i. a brief history preceding, and explanation for, the status quo should physicians be subject to losing their reputations, careers, and livelihoods-with the attendant catastrophic risks to their families, personal and provider-patientrelationships, and physical and mental wellbeing-based on disciplinary authorities' beliefs that, metaphorically speaking, it is anything more than fifty percent likely that they are guilty of ''professional misconduct"? we think not, but the fact is that physicians are at risk in the approximately three-quarters of our states that employ the preponderance of the evidence standard of proof in disciplinary proceedings.6 conversely, attorneys are protected from such risk in most of the states, probably in part because the american bar association has long officially endorsed the position that lawyers should be subject to discipline only upon clear and 4. jost, supra note 1, at 309-10 (reviewing complaints closed by the ohio state medical board in 1990 and focusing on who files complaints and "the process of complaint investigation and the types of action taken by boards against physicians as a result of complaints''). 5. federation of state medical boards (''fsmb''), suiiui1qry of 2004 board actions, available at http://www.fsmb.org (last visited june 9, 2006). the statements in the text concerning the percentage ofboards that use the competing standards ofproofis based on the report's data for each state's medical board, not counting separate medical boards that govern only osteopathic physicians. the report has separate pages summarizing each state's actions for the year, and each such compilation also lists the standard of proof each board reports using. the following boards report using the preponderance of the evidence test: alaska. arizona. arkansas, colorado, connecticut, delaware, georgia, hawaii, idaho, iowa, kentucky, louisiana, maine, massachusetts, michigan, minnesota, mississippi, missouri, montana, nevada, new hampshire, new jersey, new mexico, new york. north carolina, ohio, oregon, pennsylvania, rhode island, south carolina, tennessee, texas, utah, vermont, and wisconsin. the following boards report using the clear and convincing evidence test: alabama, california, florida, illinois, indiana, kansas, maryland, nebraska, oklahoma, south dakota, virginia, washington, west virginia, and wyoming. see johnson v. bd. of governors of registered dentistsofoida., 913 p.2d 1339(0lda. 1996)andettingerv. bd. ofmed. quality assurance, 135 cal. app. 3d 853 (cal. app. 1983) discussed infra note 21 for different articulations of the stricter standard. similarly, alabama code§ 34-24-360 (west 1975, as amended 2002) sets forth a confusing amalgam of"substantial evidence" and "reasonableness" tests. the respective boards have ignored such different articulations of the various standards when reporting to the fsmb. further research is warranted concerning whether respective boards are aware of and/or are influenced by disparate articulations of the various standards of proof in governing statutes, regulations, and case law. 6. id. 2006] constitutionally mandated standard of proof 109 convincing proof (metaphorically speaking, say, a seventy-five percent probability of guilt). 7 the american medical association ("ama") is generally supportive of civil rights, including due process oflaw for physicians,8 but it has not taken a position on the question of which standard of proof should apply in disciplinary proceedings. perhaps the ama is preoccupied with the admittedly important question of medical malpractice suits. it is also likely that organized medicine is hesitant to push for greater protections in disciplinary proceedings because oflikely complaints from some quarters of catering to its members', rather than the public's, interests. it is time for physicians and persons concerned with basic fairness and good public policy to focus on this important issue. greater protections for physicians are consistent with both public interests and physicians' rights, and, considering both the magnitude and probability ofliability, the overall risks to physicians are of similar import in the medical malpractice and disciplinary contexts. physicians are about a third as likely to be convicted of professional misconduct reportable to the national practitioner data bank as they are to have to make a reportable medical malpractice payment.9 although the likelihood of a reportable misconduct conviction is less, the magnitude of the harm is arguably greater. misconduct proceedings can cost tens (rarely, hundreds) of thousands of dollars in legal fees, are sometimes covered by limited or no insurance; are not graced by all the protections attendant to liability suits (e.g, hearsay evidence is commonly accepted),10 and can lead to professional death via license revocation. similarly, while the number of malpractice payouts has been fairly stable for a number of years, 11 misconduct sanctions increased by thirty-six percent from 2000 to 2004 and by twenty 7. david m. appel, note, attorney disbarment proceedings and the standard of proof, 24 hofstral. rev. 275,281, and 285 n.86 (l995)(citingto rule 18(c)ofthe aba's model rules for lawyer disciplinary enforcement (1993)); in re benjamin, 698 a.2d 434, 439 (d.c. app. 1997) ("in new york, unlike most states, misconduct must be proven only by a fair preponderance of the evidence rather than by clear and convincing evidence.''). 8. see, e.g., ama code ofmedical ethics, ethical opinion 9.05 due process, council on ethical and judicial affairs, available at http://www.ama-assn.org (last visited june 9, 2006). 9. the national practitioner data bank, 2003 annual report, available at http://www.npdb-hipdb.com, p. 3 (showing 15,289 physician malpractice payment reports in 2003) (last visited june 9, 2006); fsmb, summary of 2003 board actions, available at http://www.fsmb.org (showing 5,230 reportable (including 4,590 prejudicial) disciplinary actions in 2003) (last visited june 9, 2006). 10. bruce e. v odick, ama office of the general counsel, medical discipline, part vlll. procedural matters, 235 jama 1051, 1051-53 (1976). 11. national practitioner data bank, supra note 9, at 18-19 (physician malpractice payment reports increased by five reports from 2002 to 2003; however, there were 8.2% fewer physician malpractice payment reports in 2002 than there were in 2001 ); geoff boehm, debunking medical malpractice myths: unraveling the false premises behind"tort reform," 5 yale j. hbaltii pol'y l. & etiiics 357, 358 (2005). 110 indiana health law review [vol. 3:103 percent from 2003 to 2004 alone.12 this increase is likely due at least in part to continued demands that disciplinary boards-which are themselves judged by the number and severity of convictions they achieve-deal more severely with physicians. 13 the grave risks associated with disciplinary proceedings are such that one might expect that the proceedings would be subject to not just the clear and convincing evidence standard, but the beyond a reasonable doubt standard which is constitutionally required in criminal cases. to the contrary, however, the history of the standard ofproofin disciplinary proceedings is largely one of embrace of the preponderance standard and an unsophisticated and sometimes completely erroneous understanding of the dynamics and realities ofboard proceedings in the various states. for example, in late 1990 the inspector general of the united states published, state medical boards and medical discipline. this report erroneously claimed that "most boards must base any disciplinary actions they take on a 'clear and convincing' standard of proof," attributing its statement to unnamed federation of state medical boards ("fsmb") personnel and "discussions with board officials in many states."14 a state-by-state review of the standard of proof published in 1992 found, however, that only fifteen states utilized the clear and convincing standard. 15 this was confirmed in 1993 by the fsmb in the first of what are now biennial tables on the issue contained in its publication, the exchange.16 the inspector general's 1990 report recognized that the higher standard "provides greater protection for physicians," but found this protection not to be justified because of the standard's supposed interference with "the boards' capacity to review cases expeditiously and effectively."17 the report did not provide support for its conclusions and was thus willing to sacrifice physicians' rights based on speculation. its cavalier attitude toward due process was out-of-date even then, but nevertheless reflects a posture that has endured concerning the standard of proof and medical discipline. for example, the fsmb continues to endorse the preponderance standard using the same reasoning "informing" the inspector general's 1990 report,l 8 and 12. damon adams, medical board discipline up; lawmakers demand even more, am. med. news, may 9, 2005, at 1. 13. id. 14. richard p. kusserow, inspector general, oei-01-89-00560, state medical boardsandmedicaldiscipune, c-3 n. 21 (aug. 1990). 15. davida.swankin,aresourceguideforrespondingtoattemptstoweaken state medical licensing boards by legislating a higher standard of evidence 6 (citizen advoc. center 1992). 16. section 3.~ physician liceming boards and physician discipline, the exchange (fsmb 1992-1993), available at http://www.fsmb.org (last visited june 9, 2006). 17. /d. at 9-10. 18. the fsmb's embrace of the preponderance standard is set forth in its, a guide to the essentials of a modern medical practice act,§ x. d. (loth ed.), available at http:/lwww.fsmb.org (last visited june 9, 2006). an explanation for embrace of the preponderance standard is set forth in the fsmb's maintaining state-based medical licemure 2006] constl1utionally mandated standard of proof 111 today still only approximately one quarter of the states utilize the clear and convincing standard. 19 nevertheless, careful application of the test the supreme court has promulgated for usually determining what procedural protections the due process clause requires establishes that the clear and convincing standard is both constitutionally and prudentially mandated the court announced this test in mathews v. eldridge, which requires balancing: first, the private interest that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute procedural safeguards; and finally, the government's interest, including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirements would entail.20 although subsequent to mathews several state courts have addressed physician disciplinary proceedings and which standard of proof is required by either federal and state constitutional protections or wise choice, many of these divergent opinions are conclusory and, although there are some well­ reasoned opinions, none covers all the relevant legal; moral, and policy issues.21 similarly, a lack of rigor marks the limited amount of and discipline: a blueprint for uniform and effective regulation oft"m medical profession, available at http://www.fsmb.org, the recoti11dejldadons of which were adopted as policy by the fsmb's house ofdelegates, may 1998 (last visited june 9, 2006). 19. see supra note 6 and accompanying text. 20. mathews v. eldridge, 424 u.s. 319, 335 (1976); cf., for example, medina v. california. 505 u.s. 437, 445 (1992) (holding that mathews test does not apply to criminal cases). 21. see, e.g., nguyen v. wash. dept. ofhealthmed. quality assurance comm., 29 p.3d 689, 690-97 (wash. 2001) (relying on constitutional analysis to support use of the clear and convincing standard); painter v. abels, 998 p.2d 931, 940-941 (wyo. 2000) (holding legislature's 1995 change ftomhigherto lower standard unconstitutional under both federal and state constitutional due process protections; apparently also relying on state equal protection analysis and finding distinction between lower standard for physicians and higher standard for other professionals "irrational" (an unlikely result under federal rational basis analysis but a viable argument under state constitutions that use an enhanced rational basis test); invoking due process precedents under both constitutions but reasoning. inconsistently with the above, that its holding might go beyond federal requirements; and mentioning quasi-criminal nature of the proceedings, loss of livelihood and reputation, "substantial" state interest in protecting citizens, and high risk of error where the agency acts as investigator, prosecutor, and judge); cooper v. bd. of prof. discipline ofthe idaho state bd. ofmed., 4 p.3d 561, 566,568 (idaho 2000) (holding that proper burden of proof is higher one but court defers to boards unless their findings are "clearly erroneous and unsupported by substantial evidencej; mcfadden v. miss. state bd. ofmed. licensure, 735 so.2d 145, 151-52 (miss. 1999) ("because the licensure statutes and regulations at issue in this case are penal in nature, the board is required to prove 112 indiana health law review [vol. 3:103 comment on the standard of proof in the medical and legal literature. 22 we its case against dr. mcfadden by clear and convincing evidence .•. "); johnson v. bd. of governors of registered dentists of okla., 913 p.2d 1339, 1345-47, 1353-56 (okla. 1996) (holdingthathigherstandardrequired understate and federal constitutions because proceedings are penal in nature, physician can lose livelihood and reputation, and risk of error is high because of combination of investigatory, prosecutorial, and adjudicatory functions; partial dissent asserting that "[t]hirty-nine state medical boards profess to use the preponderance ... standard for all offenses, eighteen use the clear and convincing standard for all offenses, and four use some variation of standards ..• " and citing health provider cases assertedly showing "[a) majority of other states [had] upheld the preponderance .. ; standard as constitutional" while only four jurisdictions hadbythen struck the preponderance standard); robinson v. okla., 916 p.2d 1390, 1393(0kla. 1996)(extendingjohnsontophysicians); ettingerv. bd. ofmed. quality assurance, 135 cal. app. 3d 853, 855-58 (cal. app. 1982) (adopting "clear and convincing proof to a reasonable certainty" standard-which is an example of oneofthe slightly ~t sets of words used' to articulate the competing standards in some states due to public policy considerations). but cf. anonymous v. state bd. ofmed. examiners, 496 s.e.2d 17, 1920 (s.c. 1998) (holding that neither due process nor equal protection requires the higher standard, and with no reasoning other than implication that only a property interest is involved); rife v. dept. ofprof. regulation, 638 so.2d 542, 543 (fla. dist ct. app. 1994) (applying a higher standard but contending that, "[a]lthougb there is a growing trend toward use of the more rigorous standard, it is apparent that such standard is not essential to satisfy due process under the united states constitution ... ");gandhi v. w'ts.; med. examining bd., 483 n.w.2d 295, 298-300 (wis. 1992) (holding that given physicians' threat to health, equal protection does not require higher standard even though attorneys are afforded the same and that due process not violated because substantial loss can be vitiated by reinstatement, public protection is more important than doctors' rights, mediciallicensure is a privilege rather than a fundamental right such as protection of parent-child relationships, notice and hearing are sufficient safeguards, and, because physicians are the primary judges,. they are .likely to be uniquely qualified to understand the evidence and stan~); ruckerv. mich. bd. ofmed., 360 n.w.2d 154 (mich. app. 1984) (rejecting due process argument without reasoning or authority); in re polk, 449 a.2d. 7, 10-17 (n.j. 1982) (concluding erroneously that procedural due process requires a fundamental right to support the higher standard and rejecting that standard under federal and state constitutions, noting wssibility of reinstatement, reasoning that public protection outweighs doctors' rlghts, andrejectinghigherstandard because "neither an intrinsically elusive or esoteric subject matter, nor the absence of reliable e\'idence, nor the exclusive possession of evidence by one party" is present, physicians are uniquely qualified judges, and the substantive standards supposedly generallyrequiretlagrantmisconductand are objective); sherman v. dist of columbia ct. of app., 407 a.2d 595, 600-01 (d.c. app. 1979) (holding that license is not sufficiently important to require higher standard because discipline i& "not a penalty or forfeiture," other safeguards are sufficient, public protection is paramount, and the "mixture of expert and lay consideration of issues ... may be teclmically complex"). 22. t. widner, south dakota should follow public policy and switch to the preponderance standard for medical license revocationa after in re medical license ofdr. reuben setliff, m.d., 48 s.d. l. rev. 388, 403 (2002-03) ("due process is still protected without a clear and convincing standard of proof ... ;" "logic suggests that all professional license revocation hearings do not require the same standard of proof . . . ;" "individual physician's rights are less important than a governmental interest in protecting the public ... ;" and "many boards don't bave [adequate] resources, autonomy, or leadership ... "); wayne j. guglielmo, medical boards: facing a disciplinary dilemma, 76 med. econ. 138 (1999) (attributingfsmb'srecommendinguseoflowerstandard to higher standards making it too hard to discipline ettant physicians); james gray & eric zicklin, why bod doctors aren't kicked out of medicine; 69 mel>. econ. 126 (1992) ("'n unison, ftom 63 boards: 'we need more funding"' and attributing dearth of disciplinary actions based on clinical competence to strict 2006] constitutionally mandated standard of proof 113 will consider arguments made by many of the authorities as we explore what standard of proof is required by careful appiication of each prong of the mathews test. ll. privatbintbrestsatstake a. the impact of disciplinary sanctions is similar to that of criminal punishment the first prong of the mathews test considers the private interests at stake. disciplinary proceedings threaten physicians' reputations, lives, and careers in a manner and magnitude similar to that involved in criminal proceedings. this is established by consideration of in the matter ofruffalcl3 in which the united states supreme court refused to disbar an attorney based on a prior state disciplinary board conviction. the court refused to rely on the state proceeding because ruffalo was not given notice adequate to constitute due process. the court found it important to observe that "[ d]isbarment .•. is· a punishment. or penalty imposed on the lawyer."24 subsequent courts have attached or refused to attach the label quasi­ criminal or penal when detennining due process requirements, including the· standard ofproof.2s however, they have not uniformly paid due deference to the supreme court's finding in ruffalo that disciplinary sanctions are ''penal." in addition, they have also failed to fully explore .whether the reasoning behind the supreme court's later holding that the beyond.a reasonable doubt standard is constitutionally required in criminal proceedings applies, at least with near equal force, to professional disciplinary proceedings.26 such an analysis illuminates important values 8t risk in discipiinary. proceedings, facilitates application of mathews, and indicates the clear arid convincing standard is constitutionally and prudentially required. burdens ofproot including the sometimes used and"daunting,. clear and convincing evidence standard); richard p. kusserow et al., an overview ofst.:~te mtdical discipline, 251 jama 820, 820-24 (1987) (attributing dearth of disciplinary actions based on clinical competence to "(1) the complexity, length, and cost of cases .•. ; (2) the substantial burden ofprooftbat tends to call for 'clear and convincing' evi~ rather tban the 'preponderance of evidence'; and (3) the considerable variations among physicians themselves about what constitutes acceptable practice in many filcets of medicine ... ). 23. in re ruffalo, 390 u.s. 544 (1968). 24. id. at 550. 25. painter, 998 p.2d at 940-41 (holding that quasi-criminal nature supports clear and convincing standard); mcfadden, 735 so.2d at 151-152 (stating that penal nature supports higher standard); johnson, 913 p.2d at 1353-1356; robinson, 916 p.2d at 1393 (extending .johnson to physicians); sherman, 407 a2d at 600-60 i (holding that discipline not a penalty and so lower standard sufficient). 26. in re winship, 397 u.s. 35.8, 363-68 (1970) (holding that the due.process clause of the fourteenth amendment requires the reasonable doubt standard in criminal cases and extending requirement to juvenile proa:edings involving supposed non-criminal offenses). 114 indiana health law review [vol. 3:103 the reasonable doubt standard is a cornerstone of american jurisprudence, reflecting that we prefer to allow many guilty persons to escape conviction before tolerating even one person being erroneously punished. it recognizes that conviction invariably blights a person's reputation, usually considerably limits one's life opportunities even to the extent of often taking away physical liberty, can involve but does not require either the existence or initiative of a victim, can involve but does not require compensation to an adverse party, and involves a uniquely powerful opponent. conversely, general use of the preponderance standard in civil proceedings reflects that here the government is an arbiter between contending parties as to whom there · generally is no reason for allocating any other than the minimum possible disparity of risk of error in decision making.27 . finally, the reasonable doubt standard conveys that the foregoing values and considerations outweigh the purposes that might be served by convictions that would be obtained under a lesser standard of proof: deterring the offender from future misconduct, deterring other potential offenders, rehabilitation~ incapacitation of the offender (e.g., by confinement or monitoring), or meting out just deserts. this conclusion reflects a hesitance to use persons as mere means to governmental ends and a favoring of justice over utility. the reasoning favoring the criminal standard applies almost uniformly to disciplinary cases. disciplinary cases are brought by a governmental body and might involve, but do not require, either the existence of, initiative of, or payment to a victim. the goals are the same. as in criminal proceedings: deterrence, rehabilitation, incapacitation, or just punishment. conviction invariablyblightsaprofessional'sreputationandcandestroyone'scareerand life. although disciplinary proceedings do not lead to confinement or brand one a criminal, most professionals would probably prefer a criminal conviction and at least some jail time to the destruction of a career implicit in serious disciplinary action. consider, for example, the case discussed in the next subsection (in which the disciplinary board utilized the preponderance standard). this case is not offered to contend that disciplinary proceedings are typically corrupt. as with so many factual questions raised as to the functioning of di~ciplinary boards, there is no good empirical evidence as to either their proper functioning or the accuracy of their findings. therefore, the case is offered solely as an example of how disciplinary proceedings can result in grave and unjust consequences for physicians. the mere existence of such risks is significant because, as will be further explored below, the united states supreme court has indicated that matters of justice and principle, as opposed to . utilitarian concerns, should predominate when determining the proper standard of proof. disciplinary proceedings can involve relatively minor charges and lead to light sanctions. one might argue that a preponderance standard would be 27. id. at 371-372 (justice harlan's concwring opinion). 2006] constitutionally mandated standard of proof 115 appropriate in such proceedings. this is a possibility, but any benefits this approach might lead to would have to be balanced against confusion that might result if medical board personnel untrained in law were asked to apply different standards of proof depending on the severity of the charges or potential sanctions involved in each proceeding. moreover, professional reputations are threatened regardless of the level of"unprofessional conduct" at issue. b. a case study regarding the impi:lct of disciplinary proceedings in mishler v. nevada board of medical examiners. 28 whistle-blowing neurosurgeon alan mishler's hospital privileges at washoe medical center ("wmc") were not renewed in 1983 when, in the words of the court, "[a]ccording to uncontroverted evidence, dr. mishler's colleagues, in retaliation against him for his candor, combed the hospital records for any negative findings they could generate against him."29 local anesthesiologists refused to service dr. mishler's patients and he was forced to leave the state. although the nevada board had not yet filed any proceedings against dr. mishler, it refused to respond to inquiries from other medical boards. this made it impossible for dr. mishler to work elsewhere. three years later, in late 1986, the nevada board finally filed charges and subsequently revoked dr. mishler's license. this action was overturned by the nevada appellate court and, upon remand, the board changed its sanction to a public reprimand and license reapplication restrictions. finally, in 1993, the nevada supreme court overturned the board's action, observing: [t]he board wielded its power to ruin the career of an outspoken physician while simultaneously protecting a possibly negligent or incompetent practitioner who had questionable billing procedures. although only one patient had complained about dr. mishler, and that complaint was subsequently found to be unjustified, the board purposely scrutinized dr. mishler's charts to find evidence with which to discipline dr. mishler. the board timed its proceedings against dr. mishler to limit the evidence available to him for his defense, because wmc's retention policy operated to destroy important films. also; while the board used its own rules of confidentiality as an excuse to obstruct dr. mishler's access to evidence, it violated the same policy with respect to dr. mishler's confidential reports. the board knew that dr. mishler was so impoverished that he had declared 28. mishler v. nev. state bd. ofmed. examiners, 849 p .2d 291 (nev. 1993). 29. jd. at29~97. 116 indiana healm law review [vol. 3:103 bankruptcy, and that he could ill afford to hire counsel. finally, even though the board had the right to obtain the. records and dr. misher did not, the board attempted to shift the burden for the preservation of evidence to dr. mishler. despite the ·absence of this evidence-office x-rays~ and · diagnostic films-at the hearing, the· board disciplined dr. mishler.· in short; we conclude that the board's actions and proceedings against dr. mishler constituted a disturbing abuse of its power. 30 dr. mishler spent another eleven years ping ponging between federal trial and appellate cqurts seeking damages against members ofthe board for the violations ofhis constitutional rights. 31 he was finally thrown out of court in 2004 because his attorney had waited too long to seek permission to add as adefendantthe nevada board secretary, thepersonapparentlyresponsible for ignoring inquiries from other state boards.32 c. case law concerning the weight of the private interests at stake the washington supreme court's opinion in nguyen v. washington department of health medical quality assurance commissio,r3 correctly explains how the private interests at stake in disciplinary proceedings favor application of a clear and convincing standard: the intermediate clear preponderance standard is required in a variety of civil situations ''to protect particularly important individual interests," that is, those interest more important than the interest against erroneous imposition of a mere money judgment. addington [v. texas],. 441 u.s. at 424. examples of such proceedings include involuntary mental illness connnitment, fraud, "some other quasi-criminal wrongdoing by the defendant'' as well as the risk of having one's ''reputation tarnished erroneously." jd · medical disciplinary proceedings fit triply within this intermediate category because they (1) involve much more than a mere money judgment, (2) are quasi-criminal, and (3) also 30. /d. at 297. 31. mishlerv. nev. state bd. ofmed. examiners, 94 f.3d 652, 1996 wl 467667, at *4 (9th cir. 1996) (unpublished disposition); mishler v. clift. 191 f.3d 998, 1004-08 (9th cir. 1999); mishlerv. avfsy, 90 fed. appx. 230,231-32 (9th cir. 2004). 32. /d. . 33. nggyen v. wash. dept. of health med. quality assurance comm., 29 p.3d 689 (wash. 2001)~ 2006] constitutionally mandated standard of proof potentially tarnish one's reputation. addington makes yet a further distinction: it observes while the interest of the individual may dictate a higher standard of proof to avoid erroneous deprivation, important interests of the state are likewise vindicated by the higher burden .... by the same token society also has the important dual interests that (1) dr. nguyen's standard of practice not fall below the acceptable minimum and (2) he not be erroneously deprived his license, as that would erroneously deprive the public access to and· benefit from his services. here each interest dictates a more exacting burden than mere preponderance. 34 117 on the other hand, cases holding that the preponderance standard is constitutionally sufficient either ignore the importance of the private interests, erroneously imply that mere property interests are at stake, or incorrectly reason that only permanent deprivations or intrusions on fundamental rights can require a higher standard. 35 the position that only intrusions on fundamental rights can justify the clear and convincing evidence test not only ignores controlling procedural due process opinions such ·as addington v. texas ,36 but also misapplies substantive due process doctrine to the procedural due process context.37 34. /d. at 693. 35. rucker v. michigan bd. ofmed., 360 n.w.2d 154 (mich. ct. app. 1984)(rejecting due process argument in favor of clear and convincing standard without reasoning or authority); anonymous v. state bd. ofmed. examiners, 496 s.e.2d 17, 19-20 (s.c. 1998) (holding that neither due process nor equal protection requires the clear and convincing standard with no reasoning other than the implication that only a property interest is involved); in re polk. 449 a.2d 7, 10-17 (n.j. 1982) (erroneously concluding that procedural due process requires a fundamental right to support the clear and convincing standard). 36. addington v. texas, 441 u.s. 418 (1979) which is discussed in the quotation from nguyen in the text at note 34 and in the text accompanying notes 40-46, and santosky v. kramer, 455 u.s. 745 (1982) which is discussed in the text at notes 47-52. 37. substantive due process doctrine provides that strict scrutiny in the form of the compelling state interest test will apply if there is a substantial intrusion on a fundamental right, but procedural due process analysis determines the degree of protections necessary by comparing the respective ~overnmental and private interests involved without a predetermined threshold concerning the nature or weight of the governmental interest. the possible exception is that court opinions have stated that enhanced procedural protections are only indicated when private interests greater than money are involved, but this is far short of requiring a "fundamental right." concerning substantive due process and fundamental rights, see john nowak&ronaidrotunda, constitutional law§ 11.4, at449 (6th ed. 2000). concerning procedural due process and private interests see supra notes 23-34 and the accompanying text. 118 indiana health law revjew [vol. 3:103 ffi. risks of erroneous deprivations a. who has the burden of proof regarding the standard of proof the second prong of the mathews test focuses on the degree of risk of erroneous decision making. there are multiple factors that portend error in board proceedings if they are conducted under a mere preponderance standard. however, it must be admitted that there are no empirical studies that demonstrate that the preponderance standard will result in more erroneous convictions than would occur if the clear and convincing standard were used. 38 this raises an important question regarding who has the burden of proof concerning the factual issues that arise when one attempts to apply the mathews test. such issues include the magnitude of the risk of erroneous deprivations when the preponderance standard is used, the degree of amelioration of the risk of· error that would occur under the clear and convincing standard, and the nature and amount of state interests that might be sacrificed under the clear and convincing standard. the supreme court has not clarified who has the burden of proof regarding questions raised by application of the mathews test. one might argue that the party asserting violation of procedural due process should have the burden of proving the facts necessary to establish her claim. 39 there is a strong indication from the court's opinions, however, that the burden of proof concerning the standard of proof in disciplinary proceedings should be placed on the government and/or that matters of individual justice should predominate over utilitarian or societal concerns when striking the ultimate balance dictated by the test. consider the court's opinion in addington v. texas,40 where it held that a standard intermediate to the preponderance and 38. the court observed in addington, 441 u.s. at 425 & n.3 (1979): "[ c]andor suggests that, to a degree, efforts to analyze what lay jurors understand concerning the differences among these three tests or the nuances of a judge's instructions on the law may well be largely an academic exercise; there are no directly relevant empirical studies. there have been some efforts to evaluate the effect of varying standards of proof on jury factfinding, see, e.g., l.s.e. jury project, juries and the rules of evidence, 1973 crjm.l.rev. 208 [concluding that somewhat unique articulations of the standard of proof did not seem to have an effect in a given criminal law context], but we have found no study comparing all three standards of proof to determine how juries real or mock, apply them" (bracketed material added). 39. one might counter that at least substantive due process or equal protection claims involving values stronger than mere property interests commonly involve establishing a deprivation of or intrusion on a right or interest, followed by application of a standard of review to determine whether the deprivation or intrusion was justified, for example, by "due process." here the individual has the burden of proving the interest and the deprivation or intrusion, but the government commonly has the burden of justifying the deprivation or intrusion once it is established. 40. addington v. texas, 441 u.s. 418 (1979). 2006] constitutionally mandated standard of proof 119 beyond reasonable doubt standards was constitutionally compelled for involuntary civil commitment proceedings. the court reasoned: candor suggests that, to a degree, efforts to analyze what lay jurors understand concerning the differences among these three tests or the nuances of a judge's instructions on the law may well be largely an academic exercise; there are no directly relevant empirical studies. indeed, the ultimate truth as to how the standards of proof affect decision making may well be unknowable, given that factfinding is a process shared by countless thousands of individuals throughout the country .... nonetheless, even if the particular standard-of­ proof catchwords do not always make a great difference in a particular case, adopting a "standard of proof is more than an empty semantic exercise.,. (citation omitted) in cases involving individual rights, whether criminal or civil, "[t]he standard of proof [at a minimum] reflects the value society places on individual liberty." (citation omitted). the expanding concern of society with the problems of mental disorders is reflected in the fact that in recent years many states have enacted statutes designed to protect the rights of the mentally ill. however, only one state by statute permits involuntary commitment by a mere preponderance of the evidence [citation], and texas is the only state where a court has concluded that the preponderance-of-the-evidence . standard satisfies due process. we attribute this not to any lack of concern in those states, but rather to a belief that the varying standards tend to produce comparable results. as we noted earlier, however, standards of proof are important for their symbolic meaning as well as for their practical effect.41 in the quoted passage, the court finds that although there are no empirical studies, and perhaps none that could be conducted or designed, that demonstrate that the risk of erroneous commitments will be ameliorated by use of a standard stronger than the usual civil preponderance standard, this is not a reason to find against the appellant's constitutional claim to an intermediate standard. similarly, it seems to find that appellant's constitutional claim should not be rejected just because there might be little or no difference in the outcomes under either standard. this is because of the important symbolic value of embracing respect for individual liberty. 41. /d. at424-26. 120 indiana health law review [vol. 3:103 the court made further observations that indicate its apparent presumption in favor of an elevated standard of proof. it stated, for example: in considering. what standard should govern in a civil commitment proceeding, we must assess both the extent of the individual's interest in not being involuntarily confined indefinitely and the state's interest in committing the emotionally disturbed under a particular standard of proof. the state has a legitimate interest under its parens patriae powers in providing care to its citizens who are unable because of emotional disorders to care for themselves; the state also has authority under its police power to protect the community from the dangerous tendencies of some who are mentally ill. under the texas mental health code, however, the state has no interest in confining individuals involuntarily if they are not mentally ill or if they do not pose some danger to themselves or others. since the preponder­ ance standard creates the risk of increasing the number of individuals erroneously committed, it is at least unclear to what extent, if any, the state's interests are furthered by using a preponderance standard in such commitment proceedings.42 here the court does not discount the individuat•s interest by considering only the additional risk posed by use of a preponderance standard instead of a clear and convincing standard. it does limit the state's interest to the extent it .is implicated ''under a particular standard of proof. •• it also seems to place a burden of actual proof on the state when it discounts the state's interest by observing that "it is at least unclear to what extent, if any, the state's interests are furthered by using a preponderance standard .... " the court also. reasoned: "moreover, we must be mindful that the function of legal process is to minimize the risk of erroneous decisions.'"'3 here the court seems to be stating that the mathews test is to be applied in a manner that favors the overall goal of nrinimizing erroneous deprivations of individual rights. the court further observed: at one· time or another every person exhibits some abnormal behavior which might be perceived by some as symptomatic of a mental or emotional disorder, but which is in fact within a range of conduct that is generally acceptable. 42. /d. at 425-26. 43. id. at 425 (citation omitted). 2006] constitutionally mandated standard of proof obviously, such behavior is no basis for compelled treatment and surely none for confinement. however, there is the possible risk that a factfinder might decide to commit an individual based solely on a few isolated instances of unusual conduct. loss of liberty calls for a showing that the individual suffers from something more serious than is demonstrated by idiosyncratic behavior. increasing ·the burden of proof is one way to impress the factfmder with the importance of the decision and thereby perhaps to reduce the chances that inappropriate commitments will be ordered.44 121 in the just quoted language the court considers significant the mere possibility that the elevated, clear and convincing standard will ameliorate the risk of erroneous deprivations. as pointed out above, however, it was not willing to consider significant the possibility that the state • s interests might be placed at risk by the use of that standard. rather, it discounted that possibility by stating: "it is at least unclear to what extent, if any, the state's interests are furthered by using a preponderance standard in such commitment proceedings. "45 finally, the court flatly stated: "the individual should not be asked to share equally with society the risk of error when the possible injury to the individual is significantly greater than any possible harm to the state.'>46 the actual harm to the individual is the incremental harm of confmement and stigma, if any, posed by use of the preponderance, rather than the clear and convincing, standard. the actual harm to the state includes the incremental risk, if any, of physical harm to persons and property because of a failure to commit a dangerous person because of use of the clear and convincing, rather than the preponderance, standard. in the abstract, the relative interests on both sides seem to be of comparable value. the court's finding that the individual's interest is clearly superior can only be logically explained by the court implicitly placing upon the state the burden of proving the relative risks and/or the court giving great weight to a moral principle against allowing erroneous deprivations of individual rights. the court's opinion in santosky v. kramer41 also reflects a presumption in favor of greater procedural safeguards and/or giving great weight to the symbolic value of eschewing erroneous deprivations. there the court held that the clear and convincing standard is constitutionally mandated in termination of parental rights cases. 48 it approvingly quoted the addington court's observations that the standard of proof "reflects the value society 44. id. at 426-27. 45. id. at 426. 46. addington, 441 u.s. at 427. 47. santosky v. kramer, 455 u.s. 745 (1982). 48. id. at 769-70. 122 indiana health law review [vol. 3:103 places on individual liberty" and that an elevated standard is constitutionally required when the individual faces "a significant deprivation of liberty" or "stigma.'"'9 it also distinguished lassiter v. department of social services, 5° where it had held that a parent's right to counsel in parental rights termination proceedings would be determined case-by-case. 51 the reasoning in lassiter was that the court bad created a presumption against a right to counsel in cases not involving possible confinement. this reasoning was found not to apply to other procedural due process contexts such as determination of the proper standard of proof. although the court did not explicitly say this, it can be argued to logically follow that, in the absence of a presumption against a claim to greater procedural protections, the burden of proof must then logically be placed on the government if there is to be a non-arbitrary way for decision makers to resolve a case when there is equipoise in the decision maker's mind concerning important factual questions. once again, the santosky court seemed to exercise such a presumption in favor of an intermediate standard of proof in its observations just quoted above. the same presumption seems implicit in the santosky court's further observation: "at the factfinding, the state cannot presume that a child and his parents are adversaries. after the state has established parental unfitness at that initial proceeding, the court may assume at the dispositional stage that the interest of the child and the natural parents do diverge. "52 the state could argue that it has an interest in preventing erroneous failures to find parental unfitness because they might result in serious harm to children. the court, however, ignores such a point and discounts the state's asserted interest while not discounting the individual's interest. if the court's opinions in addington and santosky are not considered controlling concerning placement of the burden of proof, for guidance one can tum to factors authorities consider relevant when determining the proper placement of burdens of proof. these include placing the burden of proof on the party who: (1) asserts the disputed proposition; (2) is attempting to change the status quo; (3) has superior access, logistically or by virtue of superior resources, to relevant data; or (4) invokes the stronger interest or policy rationale. s3 application of these factors raises complex questions such as how to treat the relationship between who asserts a proposition and who, how, and when parties find themselves involved in adjudication, what constitutes the status quo, what counts as "access,'' and how to compare the weight of interests or policy considerations prior to assignment of a burden of proof. in 49. id. at 755-756 quoting addington, 441 u.s. at 427,424. so. lassiter v. dept. of social servs., 452 u.s. 18, 31-32 (1981). 51. santosky, 455 u.s. at 751-54. 52. santosky, 455 u.s. at 760. 53. charles mccormick, mccormick on evidence § 337 (jobn strong ed., west group 5th ed. 1999). 2006] constitutionally mandated standard of proof 123 the present context, for example, one can argue: (1) either that a physician asserts a procedural violation or that the government asserts that deprivation of a liberty interest is justified by sufficient due process in the form of a hearing based on a preponderance of the evidence; (2) either that the government is attempting to change the status quo in which the physician is in good standing or that the physician is attempting to change the status quo which includes use of a preponderance standard; (3) either the physician has greater access to evidence concerning her own conduct or that the government has access to data concerning the effect of different standards of proof; and ( 4) either that the individual asserts a paramount interest in practicing her profession and avoiding stigma or the government has a superior interest in protecting the public. we will not attempt to resolve these disputes, but two points are clear. first, disciplinary proceedings usually involve interactions with alleged victims. the victims and the physicians have relevant evidence. even if a victim has died, there will usually be either surviving relatives, other medical personnel, or. written records that are accessible to the government. moreover, the government has superior resources and access to data necessary to perform any empirical studies that might provide insight into the effects of different standards of proof. second, the supreme court has found that the individual's interests in avoiding adverse action and stigma, especially that associated with a finding of misconduct, along with the moral principle of avoiding erroneous serious deprivations outweigh the government's interest in proving by a mere preponderance of the evidence, as opposed to an intermediate standard, that a person is dangerous. these two points favor placing the burden of proof on the government. b. practical or logical factors relevant to proving risks of e"oneous deprivations regardless of which party ought to have the burden of proof, there are several practical or logical factors that indicate physicians could meet the burden of proving that a clear and convincing standard is constitutionally required. the burden of proof is not a requirement that a party establish that factual contentions are more likely than not according to formal social science, statistical analyses. to the contrary, the burden of proof refers to the subjective level of certainty that the decision maker must reach. 54 if one party presents several practical or logical arguments that are sufficient to allow the decision maker to reach the required subjective level of certainty in light of · any contrary arguments made by the other party, then the burden ofproofhas been met. we will now turn to these several practical or logical considera· tions regarding proof of risk of erroneous deprivations. 54. id. at § 339, see note 4. 124 indiana health law review [vol. 3:103 1. external pressures on medical boards pose a risk of bias in favor of conviction. the media, governmental officials, and consumer interest groups put pressure on medical boards to secure convictions; they judge boards by the number of convictions boards secure proportionate to the number of physicians boards have jurisdiction over. this is exampled by public citizen's health research group's annual rankings of boards according to how many .. serious disciplinary actions" they secure per 1,000 physicians. 55 although the fsmb contends that such statistics should not be used to compare boards, it publishes a yearly composite action index based on the number and severity of convictions by which boards can judge their own performance over time. 56 fsmb 's concession that its members should judge their progress by the number of convictions they secure comes close to an admission that boards' comparative performance should be similarly judged. given further that the fsmb is devoted to enhancing the functioning of its member boards, it is not surprising that it supports use of the preponderance standard with nothing other than the speculation that it makes the job of protecting the public easier. 57 it also seems to follow that the boards are likely to reflect the same attitudes, judge their own progress by convictions, and therefore be subject to bias in favor of convictions. 55. the public citizen's health research group ("hrg"). dr. sidney wolfe director, has published rankings of state medical boardseveryyearsince 1991 based on thedatacottected by the fsmb. these rankings are available as hrg publications at http://www.citizen.org/ publications (last visited june 9, 2006). 56. in its 2005 report for disciplinary actions taken in 2004, the fsmb expanded its annual summary to include disciplinary data for each board ftom 2000-2004 and continued use of its composite action index ("car') begun in 1993. summary of2004 board actions, supra notes. the cal is computed as fottows: 1. a board's total number of actions is divided by the total number of licensed physicians in a state. 2. a board's total number of actions is divided by the total number of physicians practicing in the state. 3. a board's total number of prejudicial actions is divided by the total number of physicians licensed by the state, whether they practice in the state or not. 4. a board's total number of prejudicial actions is divided by the total number of physicians practicing in the state. a state medical board's cal is determined by the average of lines one through four. lines three and four are weighted more heavily to reflect the more serious nature of prejudicial actions. (ld. at 2). . 57. the fsmb's embrace of the preponderance standard is set forth in its guide to 1he ·essentials, supra note 18. an explanation for embrace of the preponderance standard is set forth in the fsmb's maintaining state-hosed medical licensure and discipline: a blueprint for uniform and effective regulation of the medical profession, available at http://www.fsmb.org (last visited june 9, 2006). the recommendations were adopted as policy by the fsmb's house ofdelegates, may 1998. 2006] constmjtionaily mandated standard of proof 125 · 2. vague standards of conduct are another source of serious risk of e"oneous convictions. this is one of the reasons that, in 200 l, the washington supreme court held· that its board's use of the preponderance standard violated the due process clause of the fourteenth amendment to the united states constitution, observing: the risk of erroneous deprivation is .•. aggravated when one recalls the ultimate standard of conduct the commission applies is almost entirely subjective in nature: ineompetency, negligence, malpractice, moral turpitude, dishonesty, and cor­ ruption were the claims upon which the commission based its discipline of dr. nguyen .... it is difficult to imagine a more subjective and relative standard than that applied in a medical discipline proceeding where the minimum standard of care is often determined by opinion, and necessarily so.58 other courts have claimed that :m.iltters of discipline involve objective medical facts as to which physician board members have special expertise, thus indicating a minimum risk of erroneous creprivations.59 these courts are wrong for multiple reasons. the majority of board actions relate to alleged improper use of drugs or alcohol as opposed to matters of clinical performance or competence, judging adequate clinical performance or competence involves normative as well as technical questions, and, in any event, boards invariably have non-physician members. 60 3. medical boards are invariably structured with some combination of investigatory, prosecutorial, and adjudicatory functions that presents a conflict of interest between objective decision making and securing convictions. although the united states supreme court has refused to find that the· mere blending· of functions in state medical boards itself. violates due 58. nguyen, 29 p.3d at 696. 59. gandhi v. wisconsin med. e:umining bd., 483 n.w.2d 295, 298-300 (was. 1992) (noting physicians are likely to be uniquely qualified to understand the evidence and standards); in re polk, 449 a2d at 10-17 (noting physicians are uniquely qualified judges and the substantive standards are objective). 60. furrow, supra note 2 at 76-77 (regarding bases of board actions) & at 8()..81 (domination by professionals but there are lay members). as to normative issues involved, consider, for example, that determining whether a criminal conviction reflects on the attributes necessary to a professional and should therefore lead to professional discipline obviously entails more than factual or empirical questions. 126 indiana heal1h law review [vol. 3:103 process,61 one state supreme court has held ibat it does.62 it is obvious that this blending of functions is at least one factor to consider within the mathews test. thus, the oklahoma supreme court observed in a 1996 opinion that the mathews test requires use. of the clear and convinc::ing standard in disciplinary proceedings: ''there is high risk [of error] when an agency seeks to revoke a professional license. as in this case, revocation proceedings have the agency acting as investigator, prosecutor, and decision maker. the risk is increased where, as in this case, a competitor ... serves as the investigator and makes prosecutorial recommendations ....• »63 4. risb of decision making em>r inhere in the very wording of the "preponderance of the evidence test" and in boards' informal administrative processes that lack the safeguards, such as the rule against hearsay, associated with civil trials;64 an elevated standard of proof is the only way to ameliorate these risb. an attorney who represents physicians in board proceedings correctly wrote: [b]oard and hospital proceedings rnust be conducted in a manner that affords the doctor ... d~ process. this does not mean that disciplinary hearings are held on an even playing field. they are held before panels comprised mostly of other doctors who are familiar with the system. the panel members know that before a case evet gets to a hearing, other medical professionals, during the investigation . . . already have decided that the doctor has ... committed unprofessional conduct. this creates a predisposition to find against the doctor.65 some authorities have argued that basic protections such as notice and a hearing are sufficient due process, but the supreme court recognized the fallacy of this argument in santosky v: kramer, the termination of parental rights case discussed above. 66 . even though such cases involve all the formalities of civil trials, the court nevertheless held that states must employ 61. withrow v. larkin, 421 u.s. 35, s4-s8 (1975). 62. lyness v. state bd. ofmed., 60s a.2d 1204, 1210-11 (pa. 1992). 63. johnson, 913 p.2d at 1346; robinson, 916 p.2d at 1393 (extending johnson to physicians). 64. vodick,supranote i oat ios1-s3;fredm.zeder,.dqendingdoctorslndisciplinary proceedings, 10 ariz. ati'y 22, 25-27 (2004). 65. zeder, supra note 64 at 27. 66. gandhi, 483 n.w.2d at 298-300; sherman, 401 a.2d at 600-01; santoslcy, 455 u.s. at 745 (discussed supra notes 47-52 and accompanying text). 2006] constitutionau.y mandated standard of proof at·least a clear and convincing standard, observing: [w]e reject ... that the constitutionality of new york's statutory procedures must be evaluated as a ''package." ... indeed, we would rewrite our precedents were we to excuse a constitutionally defective standard of proof based on an amorphous assessment of the "cumulative effect'' of state procedures .... . . . [t]he standard of proof is a crucial component of legal process, the primary function of which is ''to minimize the risk of erroneous decisions." ... notice, summons, right to counsel, rules of evidence, and evidentiary hearings are all procedures to place information before the factfmder. but only· the standard of proof "instructs the factfinder concerning the degree of confidence our society thinks he should have in the correctness of factual conclusions" he draws from the information. 67 127 the court also explained that the preponderance standard exacerbates the risk of erroneous decision id8ljng by falsely implying. that the focus should be on the respective amounts ("preponderance"), rather than quality, of evidence. 68 5. court appeals do not significantly reduce the risk of board e"or. this is because the standard or degree of review exercised by the courts is very limited. the specific articulations of the standard of review vary somewhat, but they all essentially reduce to the reality that courts will only overturn board findings if they are irrational.69 even then courts usually do not substitute their own decisions, but simply remand for further proceedings. correcting an erroneous board decision is almost impossible and extremely expensive. the washington supreme court recognized this in its nguyen decision: "moreover, with respect to the risk of erroneous deprivation in this proceeding, there is little solace to be found in the availability of judicial review which is high on ·deference but low on correction of errors . . . . problems inherent in an interest-depriving procedure are ... only compounded when the possibilities for factual review are extremely limited. "70 67. santosky, 455 u.s. at 757 n.9. 68. id. at 764. 69. furrow, supra note 2 at 3-19 & 3-23. 70. nguyen, 29 p.3d at 695. 128 indiana health law review [vol. 3:103 iv. the nature and weight of the government's interests and risks to these interests the third prong of the mathews v. eldridge balancing test requires consideration of the nature and weight of the government's interests and the extent to which they are at riskunder the contending procedural alternatives. the paramount governmental interest commonly argued to be threatened by utilization of the clear and convincing standard is "protection of the public." "protection of the public" has a powerful ring, but it is almost as amorphous and easy to abuse as the concept of "national security." the former (1990) inspector general, the fsmb, and some court decisions· take positions concerning the appropriate standard of proof that consist of nothing other than an invocation of this interest and an assumption that it is powerful enough to trump any possible competing interest such as physicians' rights. 71 the court's opinions in addington and santosky preclude any such conclusory resolution concerning the appropriate standard of proof. they require a careful explanation of various governmental interests, which standard each interest seems to favor, and the relative extents to which each interest is at risk under the contending standards of review. the government's interests include: ( 1) protecting the public from physical, financial, or psychological injury resulting from physician "misconduct"; (2) preserving existing physician-patient relationships and general public access to physicians; (3) generally maintaining the integrity of, and respect for, the civil justice system; (4) specifically fostering public security and respect for the law through the symbolic statement that our society will not tolerate a significant risk of erroneous deprivations when interests more important than money are at risk, especially in proceedings that entail accusation, adjudication, and punishment upon conviction; (5) avoiding administrative inconvenience and pecuniary expenses that might be associated with enhanced procedural protections; and ( 6) fostering respect for the medical profession. only interests (1) and (5) in the foregoing list, if actually at issue, clearly favor use of the preponderance standard, while only interests (2) and (4) are obviously best protected by use of the clear and convincing standard. interest (3) is closely associated with interest ( 4) and would thus seem to favor use of the clear and convincing evidence standard. 72 71. kusserow, supra note 14 at i; gandhi, 483 n. w.2d at 305. 72. one could argue that erroneous board decisions exonerating physicians could undercut the integrity of the civil justice system, but this seems highly unlikely. what little evidence there is in the published literature indicates that complainants are given little feedback concerning what actions boards take. jost, supra note 1 at 333 ("of the 200 public complaints studied, only 7 complainants received individualized letters from the board responding to the specific allegations made in their compliant. a further 141 (70.5%) were sent a standard form letter drafted by the board at the close of the case. a staggering 26% (52) got no reply at all."). what is much more likely is that physicians erroneously convicted would come to disrespect the system and use whatever status they maintained to inform others about the injustices. finally, 2006] constitutionally mandated standard of proof 129 interest ( 6) is often supported by the argument that the public will respect the medical profession only ifit diligently polices itself. this would favor use of the preponderance standard because that standard portends easier convictions. on the other hand, it can be argued that the medical profession's general embrace of the preponderance standard evidences a willingness to curry uninformed public favor by tolerating a significant risk that convictions will be the result of public pressure rather than careful decision making. it could be said to reflect a willingness to destroy individual physicians' lives, careers, and reputations even when there is a forty-nine percent chance that charges are false. it embraces utility, not justice; image, not integrity. in this perspective, maintaining respect for the medical profession would best be achieved by embrace of the clear and convincing standard. although there can be disputes regarding which standard the various.interests seem to favor in the abstract, it is clear that some of them actually support use of the clear and convincing, as opposed to the preponderance, standard. having delineated the government's interest$ and which standard they seem to favor in the abstract, we will turn to a closer examination of the interests and the extent to which they are actually at risk under the contending standards. a. interests that can be claimed to favor the preponderance standard when public protection is mentioned, the first thought that occurs is pro­ tecting patients from physical.or psychological harm caused by substandard clinical care. as indicated above, however, most board proceedings do not even involve issues o( clinical care, but, rather, alleged. abuse of drugs or alcohol. 73 it is true that physicians with an addiction problem might become incompetent clinicians. regardless, there is no good evidence that medical disciplinary proceedings offer significant protection to patients from substandard clinical care beyond that already afforded by a panoply of alternative regulatory mechanisms: criminal prosecutions; quality assurance activities by hospitals, other providers, employers, and medical societies; and medical liability suits. the conclusions of a study published in 1993 remain true today: "at this point, confidence that ·medical licensure boards are capable of systematicallyidenti:tyingincompetentpractitioners, and that board interventions can address the problems caused by such practitioners, are probably misplaced."74 · in short, the primary government interest invoked to justify the prepon­ derance standard appears to be little at issue under any standard of proof. respect for the civil justice system stems. at least in part, :from the notion that the government wiu not sanction citizens without elear justification. 73. see supra note 60 and aeeompanying text 74. jost; supra note 1, at 336. 130 indiana health law review [vol. 3:103 protecting the public from financial, as opposed to physical or psychological, harm is a weak justification for facilitating relatively easy convictions under a preponderance standard. this is not to say that financial fraud is not an important social problem.75 however, most of the costs of medical care are covered by insurance, and private and governmental insurers have the resources, incentives, and mechanisms to police physician financial miscon­ duct. these mechanisms include a panoply of fraud and abuse laws at both the federal and state levels. 76 although it is an issue that merits research, it might well be that most physician disciplinary board proceedings concerning financial misconduct are started because of prior proceedings initiated by other governmental authorities rather than complaints from the general public. 77 if so, board proceedings would seem to be redundant. maintaining respect for the medical profession also seems like a weak justification in favor of use of a preponderance standard. it is difficult to understand why this has even been mentioned as a governmental interest. the most that can be said in favor of this interest is that the public conceivably will only feel secure, and therefore best benefit from medical treatment, if it respects physicians generally. it can be argued, to the contrary, that patients better protect themselves through a healthy skepticism and inquiring attitude toward medical professionals. a final state interest that might be suggested to support the prepon­ derance standard is preventing administrative inconvenience or expense. this too is an issue that might merit research. however, what little practical or logical argument that exists suggests that use of the clear and convincing standard will not cause significant administrative inconvenience or expense. consider the santosky court's observations concerning use of_ the clear and convincing standard in parental termination proceedings: "[a] stricter standard of proof would reduce factual error without imposing substantial fiscal burdens upon the state ... 35 states already have adopted a higher standard by statute or court decision without apparent effect on the speed, form, or cost of their factfinding proceedings. "78 although only about a quarter of the states use the clear and convincing standard, there has been no indication that these states have experienced any significant increase in inconvenience or expense. to the contrary, as indicated below, the state with 75. see h.r. rep. no. 104-161 (1996) (stating that "[a]ccording to the [government accounting office], [ten percent) of every health care dollar spent in this nation is lost to fraudulent and wasteful provider claims''). 76. see the various statutes and regulations described in furrow, supra note 2, chapter 15, medicare and medicaid fraud and abuse. 77. jost, supra note 1 at 312 tbl. 1 (showing one study that revealed only (thirty-eight] percent of complaints during 1990 came from the public). 78. santosky, 455 u.s. at 767 (1982). 2006] constitutionally mandated standard of proof 131 the most convictions per one thousand physicians .. uses the clear and convincing evidence standard. 79 finally, concerning administrative convenience and expense and all the state interests that might be argued to support use of the preponderance standard, as indicated above, addington and santosky provide that either (1) the state cannot claim an interest that might be based on erroneous convictions facilitated by a lower standard of proof, or, at the very least, (2) the state's interest must be discounted by the amount it would be protected under an enhanced standard of proof. 80 the addington court noted the lack of empirical data and surmised that there was probably little difference in the results under the preponderance and clear and convincing standards. what little evidence there is indicates that the ability to establish firm cases is primarily a function of the overall resources and autonomy a board has. many boards are severely under-funded and some lack adequate autonomy. 81 the actual performance of boards in taking action against errant physicians indicates that the resources, autonomy, and competence ofboards, rather than the standard of proof, are the keys to success. thus, the medical board with the highest reported rate of convictions proportionate to physicians within each board's jurisdiction, as set forth in the fsmb 's composite action index for 2004, utilized the clear and convincing evidence standard. the two boards with the lowest reported rates of convictions employed the preponderance of the evidence standard. 82 invoking the need to allow easy convictions under a preponderance standard, as has essentially been done by the former inspector general, the fsmb, and certain judges, draws attention away from the problems of inadequate funding and autonomy that plague many boards. furthermore, legislatures are not likely to allocate more .funds to boards just because of a voluntary or forced switch to the higher standard. it is likely that given a switch from the preponderance to the clear and convincing standard and holding resources constant, medical boards will be more careful in choosing cases to pursue. they could become more efficient and effective. thus, for example, we doubt that the then members of the nevada medical board would have had the temerity to pursue their above-described vendetta against dr. mishler if they knew that they could be called upon to show that their actions were based on clear and convincing evidence. 79. see infra notes 80-82 and accompanying text. 80. id. 81. kusserow, supra note 14 at i-ii. 82. the board with the highest cal was florida, and the two boards with the lowest cal's were mississippi and nevada. summary o/2004 board actions, supra notes. 132 indiana health law review [vol. 3:103 b. interests that apparently support use ofthe clear and convincing standard it should be evident from the preceding discussion that preventing increased administrative inconvenience or expense and fostering respect for the medical profession might be better advanced by the clear and convincing, as opposed to the preponderance, standard. moreover, public safety or well­ being can be threatened by false acquittals and convictions. when a physician is suspended or expelled from the profession, there is not only destruction of ongoing specific physician-patient relationships but also a possible impact on the overall access to physician services. this is particularly true as to rural communities with limited physician coverage. there are also related state interests tha:t the supreme court has indi­ cated are of paramount importance in this context: (1) generally maintaining the integrity of, and respect for, the civil justice system, and (2) specifically fostering public security and respect for the law through the symbolic statement that our society will not tolerate a significant risk of erroneous deprivations when interests more important than money are at risk, especially in proceeding$ that entail accusation, adjudication, and punishment upon conviction. these interests are only advanced through use of the clear and convincing standard. here it is appropriate to recall and add to our previous quotation from the washington supreme court's opinion concluding that the clear and convincing standard is constitutionally mandated: addington makes yet a further distinction: it observes while the interest of the individual may dictate a higher standard of proof to avoid erroneous deprivation, important interests of the state are likewise vindicated by the higher burden as they are potentially compromised by a lower burden of proof which inevitably increases the incidents of erroneous results. (citation omitted). aside from vindicating interests of accuracy in professional disciplinary proceedings, as dean roscoe pound observed, ''there is a public policy in maintaining the interests of individuals as well as one in upholding the agencies of government." it is important to focus on the nature of the interest at stake in the sense that the more important the interest, the more process is required. the interest of the individual is the primary concern; however, important interests of the state likewise merit a higher burden. a traffic infraction results in a fine . . . . however, charges of aggravated first degree murder may result in the death penalty on the one hand or a killer on the loose on the other. we, as a civilized society, will risk a mistake in the former but tolerate no wrongful conviction in. the latter. so too with dr. nguyen: his 2006] constitutionally mandated standard of proof professional license, his reputation, his ability to earn a living for his family are very important interests-much more important than money alone. by the same token society also has the important dual interests that (1) dr. nguyen's standard of practice not fall below the acceptable minimum and (2) he not be erroneously deprived his license, as that would erroneously deprive the public access to and benefit from his services.. here each interest dictates a more exacting burden than mere preponderance.83 133 in fact, it can be argued that the integrity of the civil justice system and preservation of our commitment to preventing unjust punishment require use of the beyond a reasonable doubt standard employed in criminal cases. the santoskycourtconfronteda similar argument when it considered the constitu­ tionally required standard of proof in termination of parental rights cases. the court's explanation there concerning why it favored the clear and convincing standard even in light of the severe and permanent deprivation at issue is apt here. the court reasoned: in addington, the court concluded that application of a reasonable-doubt standard is inappropriate in civil commitment proceedings for two reasons-because of our hesitation to apply that unique standard "too broadly or casually in noncriminal cases," (citation omitted) and because the psychiatric evidence ordinarily adduced at commitment proceedings is rarely susceptible . to proof beyond a reasonable doubt .... like civil commitment hearings, termination proceed­ ings often require the factfinder to evaluate medical and psychiatric testimony, and to decide issues difficult to prove to a level of absolute certainty . . . . the substantive standards applied vary from state to state. although congress found the "beyond a reasonable doubt" standard proper in [termination oflndian parental rights case], another legislative body might well conclude that a reasonable-doubt standard would erect an unreasonable barrier to state efforts to free permanently neglected children for adoption. 84 the same reasoning applies to physician disciplinary proceedings. first, they often involve complex medical or scientific matters that can be 83. nguyen, 29 p.3d at 693 (citation and footnote omittedxempbasis in original). 84. santosky, 455 u.s. at 768-769 (citations omitted). 134 indiana health law review [vol. 3:103 impossible to prove beyond a reasonable doubt second, they are quasi criminal, but not criminal in nature. third, the substantive definition of ''unprofessional conduct" varies among the states. v. balancing the various interests the final step in the mathews test is to balance the weights of the respective public and private interests. this balancing is not to be done in the abstract, but with careful consideration of each competing interest, the degree to which it is at risk, and which procedural alternative places each interest at risk. those who have made the clear and convincing standard of proof a straw man to attack as the source of poor medical board performance ignore rigorous analysis and posit a false clash between physicians' rights, on the one hand, and public safety, on the other hand first, the interests that have been argued to be threatened by use of the clear and convincing standard can just as well be placed at risk by the preponderance standard. as explained above, public safety can be threatened both by making convictions too easy and too difficult. to secure. the same is true concerning respect for the medical profession. no profession is worthy of respect if it is willing to sacrifice the rights of some of its members to allay public pressure for more control of the profession as a whole. second, even if public safety or other interests are assumed for purposes of argument to be at some risk under the clear and convincing evidence test, questions remain as to the extent of such risks and their relative value when balanced against physicians' constitutional and moral rights and the integrity of the disciplinary process. despite this axiomatic proposition, the former inspector general, the fsmb, and certain judges have in essence abstractly argued: "protecting citizens is one of the fundamental reasons for a government's existence. this obligation of the state is superior to the privilege of any individual to practice his or her profession. "85 this is akin to arguing that we should all sacrifice our rights on the altar of ''national security." we suggest, instead, that longstanding constitutional precepts should guide the analysis. careful application of the mathews test in light of subsequent supreme court opinions that consider the standard of proof constitutionally required in involuntary civil commitment and termination of parental rights proceedings shows that the scales of justice tip in favor of use of the clear and convincing standard in physician disciplinary proceedings. the supreme court has indicated that the government has the burden of proof concerning the constitutionally required standard of proof and/or that matters 85. gandhi, 483 n.w.2d at 305. 2006] constitutionally mandated standard of proof 135 of individual justice and avoidance of unjust punishment outweigh utilitarian or societal concerns in this context. the clear and convincing standard should be kept in the quarter of the states that now use it, and it should be extended as a matter of policy to the remaining states. intransigent states should be confronted with litigation that attempts to extend the holdings of the few state courts that have given close attention to the matter and found that the clear and convincing standard is mandated by either federal or state constitutions or wise moral or policy analysis. 86 86. see sources cited supra note 21. health should not be a determinative factor of whether one will be a suitable adoptive parent brenda k. devries• table of contents i. introduction ............................................................................... 137 ll. courtdeniesobesecouple'srequesttoadopt ................. 140 ill. the adoption system in me united states ........................... 141 a. history of adoption .................................................................. 141 b. current standards for adoption ............................................... 142 c. adoption assistance and child welfare act of 1980 ................ 143 d. factors for consideration in adoption .................................... 144 e. defining what makes a parent a "parent" ............................. 146 iv. the weight debate: nature vs. nurture .............................. 149 a. studies in favor of genetics .................................................... 150 b. studies in favor of lifestyle choices ....................................... 152 c. balanced approach .................................................................. 1.53 d. overweight versus obesity ...................................................... 154 v. weight-based discrimination claims .................................... 155 a. title vii .................................................................................... 156 b. ada and the rehabilitation act ............................................... 157 c. equal protection under the fourteenth amendment ................ 159 d. state claims ............................................................................. 161 vi. comparing weight to 0tiier ileal til choices/ characteristics .......................................................................... 162 a. comparing weight to smoking ................................................ 162 b. comparing weight to hiv and aids ....................................... 165 vii. conclusion .................................................................................. 168 . i. introduction i didn't want to be just another orphan, mr. w arbucks. i wanted to believe i was special ... i'm going to have a regular mother and father, like a regular kid. i am! 1 • j.d. candidate, 2008, indiana university school of lawindianapolis; b.a., 2004, calvin college. 1. annie (columbia pictures corporation 1982). 138 indiana health law review [vol. 6:137 the 1982 musical, annie, tells the story of a fiery young orphan girl who finally catches a break when she is selected to spend a short time at the lux­ urious residence of wealthy industrialist, oliver warbucks.2 viewers are capti­ vated as mr. warbucks's heart is softened during the course of the film and he eventually adopts annie to be his daughter. unfortunately, the majority of children are not as lucky as the fictitious red-headed annie. the number of children waiting for the love, care, and sta­ bility of a permanent home is alarming. an enormous need for people to adopt children exists in the united states due to the overcrowding of the foster care system. according to recent statistics, "[t]here are currently half a million children in foster care, with twenty percent of these children having remained there for five years or longer. ,.3 it is disturbing that "the united states has approximately fourteen million children living at or below the poverty level, which is the highest child poverty rate among all industrialized nations. "4 the high number of children living in poverty is a factor in the increase of the number of children placed in foster care. as the number of children in the foster care system in­ creases, so do the case loads of social workers, which limits "their ability to visit children, assess safety, and respond appropriately to the needs of the children and their families,"5 which in turn contributes to longer stays in foster care. "such a sequence of catch-22s is clearly not in the best interest of children, their families, or the professionals charged with their oversight.',t; even though the number of children in foster care is on the rise, adoptions in the united states have decreased since the 1970s. approximately 127,000 children are adopted every year in the united states, 7 but this is "a sharp drop since the century-long high point of 175,000 adoptions in 1970.'.s some expla­ nations for the decrease may be the smaller size of the average american fami­ ly, the more frequent use of fertility treatments for childless couples, and the changing social attitudes towards single mothers. 9 growing numbers of recent adoptions have been international or transracial, creating families where the parents and children do not look alike. 10 the attention attracted by these types 2. jd. 3. deborah paruch, the orphaning of underprivileged children: america's failed child welfare law & policy, 8j.l. & fam. stud. 119, 144 (2006). 4. !d. at 119. 5. !d. at 146. 6. id. 7. child welfare information gateway, adoption, http://www.childwelfare.gov/adoption. (last visited march 12, 2009). 8. the adoption history project, http://www.uoregon.edu/~adoptionltopicsladoption statistics.htm (last visited march 12, 2009). 9. the evan b. donaldson adoption institute, private domestic adoption facts, http://www.adoptioninstitute.org (last visited march 12, 2009). 10. the adoption history project, supra note 8. 2009] health should not be a determinative factor 139 of adoptive families has led to the mistaken belief that the total number of adoptions is increasing. 11 there is clearly an increasing need for adoptive families. adoptions are preferential over keeping children in the foster care system because adoptions benefit and protect children in a myriad of ways. when a non-biological parent adopts a child, it formalizes a parental relationship between the adoptive parent and that child which shows the child that the parent is committed to him or her. adoption guarantees that the child will be provided for financially and protects the inheritance rights of the child in case the adoptive parent dies without ex­ ecuting a will. 12 it also secures other benefits for the child, such as health in­ surance and other employment-related benefits that may be available to the adoptive parent and to members of that parent's immediate family.13 in the event that the adoptive parent becomes unemployed, disabled, or dies, an adopted child will be eligible for social security and worker's compensation benefits.14 adoption allows the parent to make decisions for the child in medi­ cal, educational, religious, and social settings.15 adoption also creates legal standing for the adopted child to bring suits, such as a wrongful death action or next of kin claims.16 given the rising need for adoptive families and the number of benefits that a child will receive after being adopted, it is surprising that any suitable prospective parents would be turned away and not permitted to adopt. unfor­ tunately, some parents attempting to adopt children are being turned away, sup­ posedly due to their health characteristics, such as obesity.17 due to the urgent need for adoptive parents, the health choices and characteristics of prospective adoptive parents should not be the determinative factor in whether they are deemed to be suitable adoptive parents. part ii of this note will detail the experience of an independence, mis­ souri family after their adoption request was initially denied, allegedly due to their health characteristics. part m will give a briefhistory of adoption, explain the current standards used for adoptions, and look at various factors used by agencies in determining whether prospective parents are eligible to adopt. the issue of whether weight is influenced more by genetics or individual lifestyle choices will be briefly addressed in part n, while part v will explore the vari­ ous methods of redress that may be pursued by persons facing discrimination based on their weight. part v will also examine whether these remedies are available to prospective adoptive parents who are denied based on their health 11. /d. 12. angela dunne tiritilli & susan ann koenig, advocacy for nebrmka children with gay and lesbian parents: a cau for the best interests of the child to be paramount in the ca!e of non-biological, non-adoptive parents, 36 creighi'on l. rev. 3, 8-9 (2002). 13. /d. 14. /d. 15. /d. 16. /d. 17. see infra part it. 140 indiana heal til law review [vol. 6:137 choices or characteristics. finally, part vi will compare weight to other health choices and characteristics, such as smoking and hiv or aids. ultimately, this note will show that courts should not be able to use a couple's health choices or characteristics as the determinative factor when deciding whether that couple will be suitable adoptive parents. u. court denies obese couple's request to adopt gary and cynthia stocklaufer, a couple residing in independence, mis­ souri, had taken in an infant from a cousin who was unable to raise him.18 the baby, max, was one week old when he was placed with the stocklaufer family and approximately one month later, the biological mother signed over parental rights to the stocklaufers.19 after three months, the stocklaufers desired to formally adopt max. 20 even though the stocklaufers were certified foster par­ ents in missouri, the family court judge did not grant the stocklaufers' adoption request and removed baby max from their home. 21 gary stocklaufer believes that the court is discriminating against him due to his weight.22 at the time of the court's initial decision, gary weighed ap­ proximately 550 pounds.23 interestingly, the same judge approved the stock­ laufers' adoption of a son, robert, in november 2000.24 gary was also considerably obese during the adoption of robert and his weight has remained consistent since 2000.25 the court-appointed guardian stated that the court's decision to deny the adoption of max was not based directly on gary's weight, but on the health risks that gary faces from obesity, such as diabetes or sleep apnea. 26 the court has a duty to consider the best interests of the child in determining a permanent placement.27 even though "[t]he amount of time, whether short or extended, spent with foster parents can have lasting effects on children,"28 the court ruled 18. jim plink, obese foster parent upset child taken away, kmbc-tv, http://www.kmbc.com/news/13763346/detail.html (last visited march 12, 2009). 19. id. 20. id. 21. /d. 22. /d. 23. melissapetri, verdict: toofattoadopt! theparentjngweblog,aug.27,2007, http://www.parenting-weblog.com/50226711/verdict _too_ fat_ to _adoptphp (last visited march 12, 2009). 24. grant slater, man has gastric surgery in adoption bid, usa today, aug. 24,2007, available at http://www.usatoday.com/newslnation/2007-08-24-2808744902_ x.htm (last visited march 12, 2009). 25. /d. 26. laura thomquist, judge says mans too fat to adopt, fox news channel 4 kansas city, july 25, 2007, available at http://www.fox4kc.com/wdafjudgesaysmanstoofuttoad-4074406,0, 7288347 .story (last visited march 12, 2009). 27. laura a. turbe, florida's inconsistent use of the best interests of the child stan­ dard, 33 stetson l. rev. 369, 384 (2003). 28. /d. at 392. 2009] health should not be a determinative factor 141 that it was best to remove max from the only family he had ever known:29 the stocklaufers plan to appeal the court's decision.30 gary decided to undergo gastric bypass surgery in an attempt to lose weight and win the court's approv­ al.31 after losing 250 pounds, gary and his wife were finally granted custody of the baby more than a year after the whole ordeal began.32 even though there is a happy ending to this story, it still does not diminish the fact that the stocklaufers' adoption request was denied initially as a result of gary's obesity. the courts did authorize the adoption after gary lost the weight,33 which shows that there were not any other concerns with the stock­ laufers' ability to be suitable adoptive parents. ultimately the court should not be able to use health characteristic, such as obesity, as the determinative factor when making decisions about whether to grant a petition for adoption. ill. the adoption system in tile united states a. history of adoption historically, the primary purpose of adoption sought to ensure the conti­ nuity of the adopter's family. 34 english common law did not include adoption; therefore, colonial america did not inherit a body of common law on adop­ tion.35 during the american civil war, orphanages typically used indenture systems where children served as apprentices and were cared for by their mas­ ters. 36 the indenture system evolved from one where children worked for food and shelter to the modem system of adoption where children become legal members of the adopter's family. 37 in the modem system, adopted children are treated the same as biological children.38 adoption law and practice is wholly statutory.39 "[a]doption exists purely as a privilege afforded by state statute. each state creates its own law to govern this legal proceeding.'..ro "parental rights and expectations involving adoption 29. thornquist, supra note 26. 30. plink, supra note 18. 31. slater, supra note 24. 32. monica evans, stocklaufter loses 250 pounds, finally abel to adopt son, fox news channel 4 kansas city, sept 14, 2008, available at http:llwww.fox4kc.com/wdaf­ stocldauferloses250pounds-7429294,0,3693038.story (last visited march 12, 2009). 33. id. 34. joseph evall, sexual orientation and adoptive matching, 25 fam. l.q. 347, 349 (1991). 35. id. 36. id. 37. id. 38. id. 39. jenny l. plager, note, foster parents and aids: considering the best interests of a foster child in in re interest of john t., 4 neb. ct. app. 79, 538 n. w.2d 761 (1995), 77 neb. l. rev. 617, 625-26 (1998). 40. turbe, supra note 27, at 372. 142 indiana heal til law review [vol. 6:137 have historically been guarded by legislative enactm.ent.'.-41 generally, modem adoption statutes are believed to date back to 1851 when the state ofmassachu­ setts passed a statute that "required the written consent of the birth parents, the joint petition by both adoptive parents for the adoption, a judicial decree of adoption, and total severance, in law and practice, of the ties between the child and the birth parents.'.-42 there is absolutely no inherent right to adopt or to become a foster parent because the adoption process is a privilege based on state law.43 it is not guar­ anteed in any state or federal constitution.44 adoption exists only where ex­ pressly granted by the law and is subject to restrictions and limitations imposed by that law.4s this makes it difficult to challenge a state's decision regarding adoption because there is no inherent right at stake. in addition, states are al­ lowed to regulate the practice of adoption. b. cu"ent standards for adoption states have the responsibility to carefully and safely place children with adoptive parents. every state employs a "best interest of the child" standard to govern adoptions.46 even though adoption laws vary among states, each statute will be construed liberally to ensure that the best interests of the child are served.47 "licensing rules, regulations, and standards all emphasize that the state's paramount duty is to the child rather than to prospective parents.'.48 "[p]ublic and private agencies that place, investigate or supervise the placement of children with adults for foster care or adoption are under a clear legal duty to protect the best interests of children. '.49 even though a state's duty is to protect the child, an adoption always in­ volves the weighing and balancing of many competing interests. the state must balance its own interests with those of the prospective parents in securing the welfare of the child. so the overall well being of a child should always take pre­ cedence over other placement factors that states or adoption agencies may con­ sider. the "best interest of the child" standard has been criticized for being va41. plager, supra note 39, at 626. 42. evall, supra note 34, at 349. 43. plager, supra note 39, at 626. 44. id. 45. id. 46. w. bradford wilcox & robin fretwell wilson, bringing up baby: adoption, marriage, and the best interests of the child, 14 wm. & mary biil rts. j. 883, 885 (2006). 4 7. turbe, supra note 27, at 312. 48. wilcox & wilson, supra note 46, at 885. 49. lynn d. wardle, adult sexuality, the best interests of children, and placement liability of foster-care and adoption agencies, 6 j. l. & f am. stud. 59, 59 (2004). 50. plager, supra note 39, at 626 (citing lindley v. sullivan, 889 f.2d 124 (7th cir. 1989)). 2009] health should not be a determinatne factor 143 gue. 51 indiana, like many other states, does not statutorily define its "best inter­ est" standard. 52 statutes in other states refer to "vague and imprecise factors, such as the physical, mental and emotional needs of the child" when attempting to determine the best interests of the child. 53 it is possible that imprecise definitions for the "best interest" standard could result in discriminatory decisions by judges. hillary rodham clinton wrote, "the 'best interests standard ... is not properly a standard. instead, it is a rationalization by decision-makers justifying their judgments about a child's future, like an empty vessel into which adult perceptions and prejudices are poured. "'54 "the failure of state statutes to specify factors that a court should consider in determining a child's 'best interest' promotes excessive, often dis­ criminatory, removal of children and permits these decisions to be based on value judgments which may not be commonly held by society or legislatively approved."55 appellate courts give great deference to trial courts and usually affirm the trial courts' decisions when hearing adoption appeals. 56 c. adoption assistance and child welfare act of 1980 the adoption assistance and child welfare act ("act") was passed in 1980 by congress57 to correct or alleviate problems in the foster care system as well as to promote permanency. 58 although the purpose of the act is to reunite the child with his or her family, if the child cannot be returned to the family, another resolution, such as adoption, should be pursued when children are not able to live with their biological parents, a child welfare agency ensures that children receive proper care by implementing a case plan and case review re­ quirements. 59 the act requires the development of a case plan for each child under state supervision.60 this plan must be in writing and include at least the following information: "a description and a discussion of the appropriateness of the child's placement; a plan for assuring proper care ofthe child and appropriate 51. andrea charlow, awarding custody: the best interests of the child and other fic­ tions, 5 yale l. & pol'yrev. 267,267-73 {1987)(criticizing the standard as overly vague and subject to abuse). 52. paruch, supra note 3, at 153. 53. id. 54. martin guggenheim. reconsidering the need for counsel for children in custody, visitation, and child protection proceedings, 29 loy. u. cm. l. j. 299, 307 (1998) (quot­ ing hillary clinton). 55. paruch, supra note 3, at 153. 56. id. 57. see adoption assistance and child welfare act of 1980, pub. l. no. 96-272, 94 stat. 500 (codified as amended in scattered sections of 42 u.s.c.) [hereinafter p.l. 96-272]. 58. abigail english, the hiv-aids epidemic and the child welfare system: protecting the rights of infants, young children, and adolescents, 71 iowa l. rev. 1509, 1544 (1992). 59. i d. at 1543. see also p.l. 96-272. 60. id. at 1544. see also p.l. 96-272. 144 indiana health law review [vol. 6:137 services for the child, parents, and foster parents; and the health and education­ al records of the child.'o61 the act also requires that a case review system be implemented to ensure that a court or administrative agency evaluates each child's status at least every six months.62 dispositional hearings to determine the future status of the child must be held within eighteen months from the date that child enters the system. 63 d. factors for consideration in adoption during the adoption process, courts and agencies will consider a list of criteria to ascertain whether a couple will be suitable prospective parents for a child.64 there are several factors considered including: "age, religion, financial stability, emotional health, capacity for parenthood, physical health, marital status, infertility, adjustment to sterility, quality of the marital relationship, mo. tives for adoption, attitudes toward nonmarital parenthood, the attitude of sig­ nificant others, total personality, emotional ·maturity, and feelings about children.'o6s where the couple lives and whether they have other children are also factors that agencies may consider when deciding among prospective adop­ tive families. 66 factors considered by adoption agencies have changed or evolved over time. at one time, agencies attempted to ensure that "every aspect of a pros­ pective placement was ideal, which included the goal of matching a child to prospective parents in terms of physical appearance, intellectual capacity, and other factors.'o67 during that era, if the placement did not meet this ideal and exact standard, many agencies believed it was best to leave the child in the sys­ tem pending a better match instead of placing him or her in an available home.68 the present goal of adoption is more general: ''provide a permanent home that is suitable for the child and that is in his or her best interests.'o69 this is evidenced by the fact that all states now employ the best interest of the child standard when evaluating prospective parents. 70 individual states may give some factors more consideration over other fac­ tors and may subject the factors to certain restrictions. for example, age restric­ tions on prospective adoptive parents are common in many states. 71 ''the 61. id. see also p.l. 96-272. 62. id. at 1545. see also p.l. 96-272. 63. ld. see also p.l. 96-272. 64. cynthia r. mabry, lofton and the future of gay and lesbian adoption, 18 st. thomas l. rev. 269, 289 (2005). 65. evall, supra note 34, at 350-51. 66. wilcox & wilson, supra note 46, at 886. 67. id. 68. id. 69. turbe, supra note 27, at 372. 70. paruch, supra note 3, at 147. 71. wilcox & wilson, supra note 46, at 886-87 (footnotes omitted). see, e.g., n.j. stat • . ann. § 9:3-43 (west 2005) (setting a minimum age of eighteen and a ten year age difference 2009] healm should not be a determinative factor 145 provisions generally set a mandatory minimum age and may require a minimum age difference between the adoptive parent and child. such provisions have, as a general rule, been held constitutional."72 other states focus primarily on the stability of the home. for instance, in the state of florida, the home study of the child and prospective parents prior to the child's placement is designed ''to select families who will be able to meet the physical, emotional, social, educa­ tional and financial needs of a child, while safeguarding the child from further loss and separation from primary caretak:ers.'m some states have adoption sta­ tues that allow "a child's wishes for adoption [to] be considered when the child is an older child."74 some people contend that health status should be an important factor for courts and agencies to consider when the prospective parents' fitness is being evaluated. 75 if one of the parents has a serious health condition that could lead to extra stress, financial concerns, familial disruptions, or even death, it could be argued that it is not in the child's best interest to be placed in that home. placing a child permanently in a home can be a challenging transition without all of the extra disruptions that may accompany serious health situations. one problem with having health status as a key factor, however, is the dif­ ficulty in determining the health of every prospective adoptive parent to a suffi­ cient degree of certainty. just because someone may be overweight, does not automatically mean that they are unhealthy and at risk for a wide array of ill­ nesses. on the other hand, a prospective adoptive parent may appear complete­ ly healthy to an agency evaluator but actually have a serious medical condition that has not yet been discovered. it is not possible to know through an efficient administrative evaluation whether a prospective adoptive parent will face a se­ rious health issue in the next month, year, or decade. therefore, courts should not be allowed to place undue emphasis on this factor and deny adoption oppor­ tunities to prospective adoptive parents based on their health alone. other countries have placed certain restrictions on prospective adoptive parents based upon health conditions. south korea and taiwan both issued guidelines that require prospective parents to have a body mass index ("bmi") below 30.76 china introduced a similar rule requiring prospective adoptive parrequirement.); wash. rev. code ann.§ 26.33.140 (west2005). 72. id. 73. wilcox & wilson, supra note 46, at 891 (quoting fla. admin. code ann. r. 65c16.005(2) (2004)). 74. mabry, supra note 64, at 293. 75. see infra part ill e and discussion about marriage of carney v. carney. 76. hannah davies, love goes to waistcouples told to shed the kilos if they want to adopt, sunday mail (australia), june 24, 2007, news, at 17; the obesity society, what is obesity, http://www.obesity.orglinformationlwbat_is_obesity.asp (last visited march 12, 2009). obesity is defined with reference to bmi, which is a measure of body fat based on height-to-weight ratio that applies to adult men and women. /d. a bmi of 30 or greater is considered obese; a bmi between 25 and 29.9 is considered overweight. id. bmi aside, as a rule of thumb, individuals who weigh 200.4 or more over their ideal body weight are considered obese; those who weigh either 1000.4 or more, or are 100 pounds over their ideal weight, are termed ''morbidly obese." ld. 146 indiana health law review [vol. 6:137 ents to have a bmi below 40.77 china also excludes "a wide variety of prospec­ tive parents, including people who are unmarried, obese or over [the age of] 50; people who have a facial deformity; and people who take antidepressants."78 in 2005, americans adopted 7,906 children from china.79 after china enacted the more restrictive regulations, the number of chinese children adopted by americans fell to 5,453 in 2007.80 it will be interesting to see how those num­ bers will be impacted in coming years, given the increasing prevalence of obesi­ ty in the united states. 81 more families are looking to adopt children from other countries outside of asia for a variety of reasons, one of which may be restrictions on age, weight, and income requirements. "of the more than 20,000 international adoptions in the [united states] last year, 732 of them were from ethiopia, a66 percent increase from 2005.'o82 with the high number of children waiting to be adopted domestically, one would hope that prospective adoptive parents would find the adoption process in the united states to be easier and more attractive than attempting to secure an international adoption. the goal of adoption should be finding stable and permanent placements with loving families for all children. "[p]ermanent placement in a judicially approved home environment through the process of adoption is clearly prefera­ ble to confining the child to a life of transience, from one foster home to anoth­ er •... "83 in order to place as many children as possible, no one group of prospective parents should ever be categorically excluded because of strict rules or regulations. e. defining what makes a parent a "parent" even though the courts employ a best interest of the child standard and consider a variety of factors, it is important to address what characteristics ac­ tually define a parent as a "parent." the case of marriage of carney v. carney involves a custody dispute between separated parents of two young boys. 84 m­ ter the separation, the mother relinquished custody of the boys to their father. 85 for reasons related to employment, the father moved to california with the boys 77. davies, supra note 76, at 17. 78. marie szaniszlo, fat and ugly can't adopt from china; new regs block would­ be parents, boston herald, dec. 20, 2006, news, at 7. 79. adoptivefamilies.com, http:/lwww.adoptivefamilies.com/china _ adoption.php (last visited date march 12, 2009). 80. /d. 81. see discussion itifra sections iv and v for statistics regarding obesity. 82. lisa nicita, ethiopian adoptions on the rise; adopting from africa; as parents em­ brace multicultural role and more children arrive. the face of the adoptive family in the united states is changing, arizona repubuc, feb. 25, 2007, at 1. 83. mabry, supra note 64, at320(citing language from statev. summers, 311 n.e.2d6, 13 (ohio 1974)). 84. marriage ofcameyv. carney, 598 p.2d 36 (cal. 1979). 85. /d. at 37. 2009] health should not be a determinative factor 147 while the mother remained in new york. 86 three years later, while serving in the military reserve, the father was injured in a jeep accident, which left him "a quadriplegic ... with paralyzed legs and impaired use ofhis arms and hands.'.s7 the following year, the mother moved for an order that would award her immediate custody of both boys. 88 even though she had not seen the children in nearly five years nor had made any contribution towards their support, the trial court ordered that the mother be allowed to move both children to new york. 89 the father appealed, alleging that the trial court abused its discretion. 90 the appellate judge ultimately reversed the trial court and permitted the father to retain custody of the children. 91 the appellate court noted that the trial court gave great weight to the father's handicap and "its presumed adverse ef­ fect on his capacity to be a good father to the boys."92 the trial court judge's ruling was "affected by serious misconceptions as to the importance of the in­ volvement of parents in the purely physical aspects of their children's lives. "93 the trial court judge appeared to be overly concerned that the father would not be able to participate with his sons in certain sporting or physical activities, which, in the judge's opinion, would not be a ''normal relationship between father and boys. "94 the appellate court held that it is impermissible for a court to rely solely on a person's physical handicap as prima facie evidence of the person's unfit­ ness as a parent, but that the court should consider several factors during its analysis.95 these factors include the parent's "actual and potential physical capabilities,"96 how the parent has adapted to the disability, how other family members have adjusted to the disability, and consider special contributions the disabled parent "may make to the family despite or even because of the handi­ cap. "97 this illustrates that the health or physical condition of a parent may be considered when determining what would best serve a child's best interests, but this factor "is ordinarily of minor importance. "98 the court also states what it believes lies at the heart of the parent-child relationship. 86. id. 87. id. 88. id. 89. id. [the] essence [of parenting] lies in the ethical, emotion­ al, and intellectual guidance the parent gives to the child 90. carney, 598 p.2d at 36. 91. id. at 45. 92. id. at 40. 93. id. at41. 94. id. 95. id. at 42. 96. carney, 598 p .2d at 42 97. id. 98. id. 148 indiana heal til law review throughout his formative years, and often beyond. the source of this guidance is the adult's own experience of life; its motive power is parental love and concern for the child's well-being; and its teachings deal with such fundamental matters as the child's feelings about him­ self, his relationships with others, his system of values, his standards of conduct, and his goals and priorities in life.99 [vol. 6:137 later the court notes that a handicapped parent is a ''whole person to the child who needs his affection, sympathy, and wisdom to deal with the problems of growing up."100 the court's statements can also be applied to parents who are obese and are dealing with the physical limitations of obesity. just because a parent, such as gary stocklaufer, is handicapped by obesity does not mean that he is unable to provide a stable and loving home where children are given the appropriate ethical, emotional, and intellectual guidance. according to the court, the health or physical condition of a parent can be considered but is typically of minor importance to the overall evaluation of the situation.101 even if the parent with the disability is physically unable to care for the child, this is not sufficient to justify removing the child from that parent, ac­ cording to the court in carney. if the parent can still fulfill his or her functions as a parent with appropriate domestic assistance, the parent"s disability should not be a determinative factor in regards to custody. there is no evidence that gary stocklaufer was physically unable to care for his potential son max. in fact, gary and his wife had adopted a son in 2000 and that placement appeared to be going smoothly.102 even if his obesity did affect his ability to provide routine care for the child, this is not a sufficient reason to deny gary stocklau­ fer' s adoption request, especially since gary's spouse is not considered obese and he could employ someone to assist with max's care. the difference between the situation in carney and the stocklaufer family is that the father in carney is the biological parent while gary stocklaufer is attempting to get the court's permission to adopt a child. even though there is a legal distinction between biological and adoptive parents, the courts will still apply the best interests of the child standard in either situation.103 therefore, courts should consider the list of factors from carney when considering if a prospective adoptive parent's obesitywilljustifyruling that gary stocklaufer will not be a suitable adoptive parent a court established factor test to determine parental fitness raises the issue 99. id. at44. 100. id. 101. id. at42. 102. see supra section ii. 103. paruch,supranote3 at 147. 2009] health should not be a determinative factor 149 that the prospective adoptive parents have a much higher burden to meet than the biological parents in order to become a parent. the prospective adoptive parent must prove that he or she is a fit parent before getting permission from the state to adopt a child.104 states do not assess a biological parent's fitness before they are allowed to bear their own children or take their baby home from the hospital. states never make any determination if the biological parent is taking that child into a stable home environment where the child will be given ethical, emotional, and intellectual guidance or if that child will have the mis­ fortune of winding up in the state's foster care system. biological parents are ·only assessed in the event there is a problem at some point after the child is tak­ en into an unstable environment; whereas prospective adoptive parents must go through a stringent assessment as part of their attempt to get a state's permis­ sion to adopt a child who desperately needs a loving home and committed par­ ents. n. the weight debate: nature vs. nurture to determine how much emphasis courts can place on the health status factor when evaluating prospective adoptive parents, specifically with regards to weight, it is important to explore whether weight can actually be controlled by the individual or if genetics are ultimately responsible for the outcome. it is still not clear to what extent weight is influenced more by genetics or an indi­ vidual's behavior and choices. no individual should be penalized for a charac­ teristic that he or she is unable to control, as long as it will not interfere with his or her ability to be a supportive and loving parent. "despite all of the time, money and energy devoted to weight loss in this country, there remains a fair amount we still do not understand about how weight and obesity work. "105 the basic premise is deceptively simple and not controversial: "[i]f a person takes more calories in than slhe expends, the excess calories are stored as fat and weight gain will result"106 once we begin to apply this on an individual level, however, things get more complicated. there are individuals who can eat an exorbitant amount of food, do not exer­ cise, but remain naturally thin. there are others who eat less, have a better diet and exercise on a regular basis, but are continuously battling weight gain. oth­ er people become "morbidly obese at a young age and remain so all of their lives. this is part of the mystery that doctors and medical researchers are cur­ rently trying to understand."107 104. wilcox & wilson, supra note 46, at 885 105. elizabeth e. theran. "free to be arbitrary and . .. capricious": weight-based discrimination and the logic of american antidiscrimination law, 11 cornell j.l. & pub. pol'y 113, 148 (2001). 106. ld. 107. id. at 149. 150 indiana health law review [vol. 6:137 a. studies in favor of genetics a person's weight may be more related to genetics than to personal health choices, despite what many people believe. after completing several studies, some of which are described in the following paragraphs, researchers at the university of pennsylvania concluded that "70 percent of the variation in peoples' weights may be accounted for by inheritance, a figure that means that weight is more strongly inherited than nearly any other condition, including mental illness, breast cancer or heart disease."108 that message is clearly con­ tradictory to the popular conception of weight loss -all a person must do is eat less and exercise more.109 dr. jeffrey friedman, an obesity researcher at the rockefeller university, shared an analogy to illustrate the powerful biological controls over weight. he stated, those who doubt the power of basic drives, however, might note that although one can hold one's breath, this conscious act is soon overcome by the compulsion to breathe. the feeling of hunger is intense and, if not as potent as the drive to breathe, is probably no less power­ ful than the drive to drink when one is thirsty. this is the feeling the obese must resist after they have lost a signif­ icant amount ofweight.110 dr. theodore vanltallie of columbia university's college ofphysicians and surgeons notes that "[t]he results [of the studies] take obesity out ofbeing a moral problemthat obese people have a lack of willpowerand put it more in the realm of metabolism,"111 further illustrating the importance of these find­ ings. dr. albert stunkard of the university ofpennsylvania conducted multiple studies in an effort to learn more about the relationship between genetics and weight.112 one study involved a danish group of 540 adoptees whose average age was forty. 113 ninety percent of the children had been adopted during their first year oflife.114 after comparing these adoptees to a registry with informa­ tion regarding their biological parents, it turns out that the adoptees were very 108. gina kolata, genes take charge, and diets fall by the wayside, n.y. times, may 8, 2007, at fl. 109. id. 110. id. (citing trisha gura, tracing leptin's partners in regulating body weight, science, march 10, 2000). 111. chubby? blame those genes; heredity plays the pivotal role in weight control, time, june 4, 1990, at health 80 [hereinafter chubby?]. 112. kolata, supra note 108, at fl. 113. id. 114. id. 2009] heal til should not be a determinative factor 151 similar to their biological parents in terms of weight and obesity.115 no matter how fat or thin their adoptive parents were or what kind of lifestyle example was set, the weight of the adoptees reflected that of their biological parents. 116 "two of the major findings from this study were that there [is] a clear relation between the body-mass index ofbiologic parents and the weight class of adop­ tees, suggesting that genetic influences are important determinants ofbody fat­ ness''117 and that no relation exists "between the body-mass index of adoptive parents and the weight class of adoptees, suggesting that childhood family envi­ ronment alone has little or no effect sic. "118 a second study by dr. stunkard involved "93 pairs of identical twins who were reared apart, 154 pairs of identical twins who were reared together, 218 pairs of fraternal twins who were reared apart, and 208 pairs of fraternal twins who were reared together."119 this study showed that the identical twins had nearly identical bmis, regardless of whether they had grown up separately or in the same home. 120 "there was more variation in the [bmis] of the fraternal twins, who, like any siblings, share some, but not all, genes."121 after this study, dr. stunkard concluded "ifboth biologic parents are fat, about 80% of their kids are going to be fat. "122 dr. jules hirsch, a research physician at rockefeller university, and dr. rudolph l. leibel, who is now working at columbia university, conducted another study. 123 they researched and observed people who had struggled with obesity since childhood or adolescence.124 these individuals resided at the rockefeller university hospital for eight months.125 scientists were able to maintain strict control over the subjects' diets so the individuals could lose weight. 126 after the individuals were 100 pounds lighter than their initial weights, scientists examined their fat cells to see if the cells had shrunk or dis­ appeared.127 the fat cells had shrunk and were now normal in size so dr. hirsch assumed that the individuals participating in this study would all leave the hospital permanently thinner, but they all regained weight. 128 one rock­ efeller researcher explained, "[i]t is entirely possible that weight reduction, in­ stead of resulting in a normal state for obese patients, results in an abnormal 115. id. 116. perspective, open forum. denver post, july 1, 2007, at perspective e-02. 117. kolata, supra note 108, at f 1. 118. id. 119. id. 120. id. 121. id. 122. chubby?, supra note 111, at health 80. 123. kolata, supra note 108, at fl. 124. id. 125. id. 126. id. 127. id. 128. !d. 152 indiana healm law review [vol. 6:137 state resembling that of starved nonobese individuals. "129 despite these studies that indicate that weight is strongly influenced by genetics, people can still make efforts to control their weight. dr. stunkard said, "[t]he results did not mean that people are completely helpless to control their weight, ... but ... it did mean that those who tend to be fat will have to constantly battle their genetic inheritance if they want to reach and maintain a significantly lower weight."130 even though people may inherit a propensity to obesity, low-fat diets and exercise may potentially help to offset genetic tenden­ cies.l3t b. studies in favor of lifestyle choices on the other hand, there are studies and articles that indicate that weight can be managed or controlled by eating a healthy and balanced diet and exercis­ ing several times each week. a group of researchers from northwestern uni­ versity's feinberg school of medicine found that "a consistently high level of physical activity [starting] from young adulthood into middle age increases the odds of maintaining a stable weight "132 maintaining a consistently high level of physical activity also decreases the amount of weight gained over time.133 this is one of the first studies to look at the relationship between physical activity and weight by examining several individuals' exercise patterns over a significant period ofyears.134 data was collected from more than 2,600 indi­ viduals who were between the ages of 18 to 30 at the beginning of the study and studied for twenty years.135 of the study participants, the ones who en­ gaged in "at least thirty minutes of vigorous activity a day such as jogging, bi­ cycling or swimming were more than twice as likely to maintain a stable bmi over the period of twenty years. "136 even the highly active individuals who did gain weight, gained an average of fourteen pounds less over a period of twenty years than people with low levels of physical activity.137 arlene hankinson, an instructor at the feinberg school of medicine, stated, "[t]he results will hope­ fully encourage young people to become more active and to maintain high ac­ tivity over a lifetime."138 the national weight control registry (''nwcr") was founded in 1994 129. kolata, supra note 108, at fl. 130. id. 131. chubby?, supra note 111, at health 80. 132. marla paul, brealdng a sweat helps control weight gain over 20 years, northwestern universi1y newscenter, nov. 13, 2007, http://www.northwestern.edu/ newscenter/stories/2007/11/cardia.html (last visited march 12, 2009). 133. id. 134. id. 135. id. 136. id. 137. id. 138. paul, supra note 132. 2009] heal til should not be a determinative factor 153 by rena wing, ph.d., from brown medical school, and james 0. hill, ph.d., from the university of colomdo.139 the ncwr was established to "identify and investigate the characteristics of individuals who have succeeded at long­ term weight loss" given the prevailing belief that few individuals actually suc­ ceed at keeping weight off for a long period oftime.140 the nwcr is currently tracking more than 5,000 individuals who have been successful at losing at least thirty pounds and keeping the weight off for a minimum period of one year.14t eighty-nine percent of individuals reported changing diet and exercise habits in order to achieve their initial weight loss goals.142 of those individuals who modified food and caloric intake, the common methods included restrict­ ing certain types of foods, limiting quantities, and counting calories. 143 while the strategies to lose the initial weight varied among individuals, strategies to maintain the weight loss were similar.144 the strategies included eating a low­ fat, low-calorie diet; frequent self-monitoring; and participating in regular phys­ ical activity.145 nearly all of the individuals engaged in regular exercise equiva­ lent to approximately one hour ofbrisk walking.146 only a mere nine percent of participants used calorie reduction without regular physical activity.147 this study indicates that regular exercise and a healthy and balanced diet can be used to manage weight, even if the individual is genetically predisposed to be­ ing overweight. c. balanced approach the centers for disease control and prevention ("cdc") believes that body weight is the result of a variety of factors, including genes, metabolism, behavior, environment, culture, and socioeconomic status.148 no one factor will be determinative of whether an individual will struggle with obesity. the num­ ber of contributing factors makes obesity a complex health issue. the cdc does, however, place more emphasis on the environmental fac­ tors that lead to obesity. according to the cdc, a main environmental factor contributing to obesity is urban sprawl, 149 or ''the uncontrolled, poorly planned, 139. the national weight control registry, http://www.nwcr.ws/ (last visited march 12, 2009). 140. !d. 141. !d. 142. !d. 143. !d. 144. !d. 145. the national weight control registry, supra note 139. 146. !d. 147. !d. 148. ctrs. for disease control & prevention, overweight and obesity: an overview, http://www.cdc.gov/nccdphp/dnpalobesity/contributing_factors.htm (last visited march 12, 2009). 149. !d. 154 indiana health law review [vol. 6:137 low-density, and single-use development, which expands from a metropolitan area. "150 based on their environment or community, people may choose not to walk to the store or to work, which may be due to the absence of sidewalks.151 "between 1977 and 1995, there was a thirty-seven percent decline in the use of pedestrian and bicycle travel partly due to the greater distances between resi­ dences and schools caused by sprawl."152 the cdc also recognizes that even though science shows that genetics plays a role in obesity, genetics do not always predict future health accurate­ ly.153 even though genetics may lead to an increased risk of weight gain, it ul­ timately depends on the person's individual behavior and choices. in some cases, genes and behavior are both important factors that contributes towards a person's obesity.154 d. overweight versus obesity regardless of whether weight is inherited or a product of lifestyle and in­ dividual choice, it is important to recognize that not all overweight people are unhealthy. just because an individual is overweight does not mean that he or she is automatically suffering from or at risk for health problems. "not all fat people have the dread[ed] diseases associated with fat [n]or do all thin people escape those diseases. an association, moreover, is not causation. patients' conditions should be treated, not their size."is5 it is very difficult to make a hard and fast rule regarding the overall health of an individual by only looking at one type of measurement or indicator. bmi measurements are not always a good indicator of health, even though some countries, such as south korea, taiwan, and china, have implemented restric­ tions on who'is eligible to adopt based on bmi.156 surgeon douglas nicholson, of brisbane's sunnybank obesity centre states, "[ m]any people with a bmi of 30 are perfectly healthy and would make fabulous parents."is7 healthy individ­ uals with a bmi of 30 would be rejected as prospective adoptive parents of children from south korea and taiwan, even though they may be healthy indi­ viduals. 158 courts should not overemphasize the health status factor and assume that an overweight individual will not be a suitable adoptive parent. there needs to 150. graham m. catlin, comment, a more palatable solution? comparing the viability of smart growth statutes to other legislative methods of controlling the obesity epidemic, 2007 wis. l. rev. 1091, 1109 (2007). 151. c'irs. for disease control & prevention, supra note 148. 152. catlin, supra note 150, at 1112. 153. c'irs. for disease control & prevention, supra note 148. 154. id. 155. perspective, supra note 116. 156. davies, supra note 76, at 17. 157. id. 158. /d. 2009] health should not be a determinative facror 155 be a distinction between being overweight or fat, which is a physical trait, and obesity, which is a health problem. as long as a person is healthy, their weight should not be a factor when the court is determining whether that person will be a suitable adoptive parent. the weight of a healthy person should not be consi­ dered more than height, hair color, or any other physical trait or characteristic. v. weight-based discrimination claims current medical studies estimate that at least thirty-four percent of ameri­ can adults over twenty years old, or over 72 million people, meet the medical standard for obesity. 159 fifty-five percent of adult americans, or 97 million, are categorized as either overweight or obese, and those numbers continue to rise. 160 considering that those estimates include the majority of adults in the united states, the risk of encountering weight-based discrimination is certainly heightened. 161 if weight is proven to be the result of genetics rather than personal health choices and clearly beyond the control of some individuals, is it permissible to discriminate on this factor, especially in the situation of prospective adoptive parents? if so, being able to discriminate on the basis of weight "has the poten­ tial to affect every single american, fat, average-weight, or thin, because, as we shall see below, there is no 'minimum weight requirement' for discrimination­ 'too fat' is squarely in the eye of the beholder. "162 "w eight.-based discrimina­ tion ... [is] a non-traditional and non-explicit form of discrimination [but it] "can have a profound negative impact on members of the target group. "163 if a person has been discriminated against based on their weight he or she may bring a weight discrimination claim at the federal, state, or local level. 164 many of them choose to pursue multiple options. 165 the likelihood of success depends on several factors, but overall, the probability of winning is fairly low, especially if the action is outside of a situation related to employment. 166 no federal law directly prohibits discrimination against overweight or obese people. 167 the person filing suit must do so under the protections of a general statute such as title vll, the americans with disabilities act of 1990, or the 159. crrs. for disease control & preve.nnon, overweight and obesity trends among adults, http://www.cdc.gov/nchslpressroom/07newsreleaseslobesity .htm (last visited march 12, 2009). 160. theran, supra note 105, at 136. 161. ld. 162. id. 163. jd. at 115. 164. jd. at 173. 165. jd. 166. theran, supra note 105, at 173. 167. sayward byrd, comment, civil rights and the "twinkie" t~: the 90()..pound goril­ la in the war on obesity, 65 la. l. rev. 303, 342-43 (2004). 156 indiana heal1h law review [vol. 6:137 rehabilitations act of 1973.168 theoretically, the claimant can also bring a constitutional suit, but the chance of winning remains very low.169 a. title vii title vii of the civil rights act of 1964, codified as amended at 42 u.s.c. § 2000e, prohibits discrimination "against any individual with respect to his compensation, terms, conditions, or privileges of employment, because of such individual's race, color, religion, sex, or national origin.''170 as of 1991, title vll recognizes both purposeful disparate treatment and facially neutral disparate impact claims.171 in the circumstance of weight, "those that succeed tend to be brought as disparate treatment, rather than disparate impact, claims."172 title vii specifically applies in the employment context, but does not ap­ ply directly to cases regarding prospective adoptive parents being denied due to their weight. title vii may be applicable, however, if an obese couple was em­ ployed as foster parents and was later prohibited from fostering children as a result of their obesity, which may indicate disparate treatment. there is a de­ bate whether foster parents are state employees or merely license holders, but it could be reasonably argued that foster parents are employed by the state.173 once the claimant makes a prima facie case of disparate treatment, the employer has the opportunity to produce evidence of a nondiscriminatory rea­ son for the different weight standards and must prove that the discriminatory standards can be justified as "bona fide occupational qualifications 'reasonably necessary to the normal operation of that particular business or enterprise' un­ der42 u.s.c. § 2000e-2(e)."174 this is a fairly onerous burden for the employ­ er to meet; therefore a title vii plaintiff who establishes disparate treatment based on one of the protected categories is in a fairly strong position. the prob­ lem is that weight is not one of those categories and without such proof, title vn affords the weight discrimination plaintiff very little relief or remedy.175 according to one author, "[ c ]ivil rights law in america is inordinately re­ sistant to extending protection to the victims of'new' forms of discrimination-­ 'new,' at least, in the sense that they are not already enshrined in our legal code, 168. theran, supra note 105, at 173. 169. id. 170. 42 u.s.c. § 2000e-2(ax1) {1995). 171. theran, supra note 105, at 175. 172. id. 173. daniel pollack. negligence and foster childrenwho is responsible? center for adoption research, feb. 23, 2008, ht1p://www.centerforadoptionresearch.org {discussing how various states classify foster parents for purposes of indemnification. for example, illinois in­ cludes foster parents as employees of the state while other states, such as south carolina, expli­ citly oppose the indemnification of foster parents as employees.) (last visited march 12, 2009). 174. theran, supra note 105, at 176-77. see also 42 u.s.c. § 2000e-2(e)(1995). 175. theran,supranote 105,at 177. 2009] health should not be a determinative factor 157 even if they have been occurring for centuries."176 this is illustrative of the problem that the weight-based discrimination plaintiff faces. discrimination on the basis of weight commonly occurs, but civil rights law in the united states does not yet provide any protection for this class of people. b. ada and the rehabilitation act the ada and the rehabilitation act apply primarily to employment dis­ crimination based on disabilities, but "provide the framework and case law re­ lated to obesity litigation."177 under either the ada or the rehabilitation act, a person establishes a claim of discrimination by proving that the plaintiffhas a disability.178 the second way to establish a claim of discrimination is to prove that "her employer believed she had an 'impairment' that, if it truly existed, would be covered under the statutes and that the employer discriminated against the plaintiff on that basis."179 in order to establish a claim under either act, the plaintiff needs to show that obesity is a disability.180 "the medical diagnosis of an impairment is not as important in defining a disability under these acts as the effects of the impair­ ment on a person's life."181 under the rehabilitation act, a person has a disa­ bility when he or she "(i) has a physical or mental impairment which substantially limits one or more major life activities, (ii) has a record of such an impairment, or (iii) is regarded as having such an impairment."182 this defini­ tion is nearly identical to, and generally interchangeable with, the ada defini­ tion.is3 major life activities are considered ''those basic activities that the average person in the general population can perform with little or no difficulty [, ... including] caring for oneself, performing manual tasks, walking, seeing, hear­ ing, speaking, breathing, learning, and working."184 this list is not comprehen­ sive, as the equal employment opportunity commission ("eeoc") also notes "other major life activities include, but are not limited to, sitting, standing, lift­ ing, reaching."185 as to the "substantially limits" language of the regulation, it is not enough to have a physical or mental impairment. 176. id. at 114. 177. jessica meyer, article, obesity haravsment in school: simply "teasing" our way to unfenered obesity discrimination and stripping away the right to education, 23 law & ineq. 429, 436 (2005). 178. id. 179. id. 180. !d. 181. id. at 436-37. 182. 45 c.f.r. § 84.3(ix1) (2005). 183. see 42 u.s.c. § 12102(2) (2000). 184. theran, supra note 105, at 180. 185. !d. 158 indiana health law review (1) the term substantially limits means: (i) unable to perform a major life activity that the average person in the general population can perform; or (ii) significantly restricted as to the condition, manner or duration under which an individual can perform a particular major life activity as compared to the condition, manner, or dura­ tion under which the average person in the general popu­ lation can perform that same major life activity. (2) the following factors should be considered in deter­ mining whether an individual is substantially limited in a major life activity: (i) the nature and severity of the im­ pairment; (ii) the duration or expected duration of the impairment; and (iii) the permanent or long term im­ pact, or the expected permanent or long term impact of or resulting from the impairment.186 [vol. 6:137 courts have interpreted the rehabilitation act broadly to include condi­ tions such as substance abuse and alcoholism as disabilities.187 the rehabilita­ tion act also "contains no language suggesting that its protection is linked to how an individual became impaired, or whether an individual contributed to his or her impairment, which is valuable in an obesity case where the cause and mutability of the condition may be at issue. "188 although weight discrimination claims have been brought under the ada and the rehabilitation act, the eeoc has found "obesity is a disability only in rare circumstances, noting its resemblance to physical, psychosocial, or cultural characteristics that are not impairments."189 a majority of courts have ruled that in the context of the ada and the rehabilitation act, obesity does not qualify as a disability or a physical impairment except in special cases.190 those courts have held obesity is not a disability without something more, such as a physiological impairment that affects weight control.191 186. 29 c.f.r. § 1630.2(j)(1)-(2) (1991). 187. see teahan v. metro-n. commuter r.r. co., 951 f.2d 511, 517 (2d cir. 1991) (holding substance abuse is a handicap under the rehabilitation act); see also gallagher v. catto, 778 f. supp. 570,577 (d.d.c. 1991) (holding alcoholism is a handicap under the rehabilitation act). 188. meyer, supra note 177, at 437 (citing cook v. r.i., dep't ofmental health, retarda­ tion, and hosps., 10 f.3d 17,24 (1st cir. 1993). 189. see 29 c.p.r. pt. 1630 app. § 1630.2(h) (2004) ("'[i]mpairment' does not include physical characteristics such as eye color, hair color, left-handedness, or height, weight or mus­ cle tone that are within 'normal' range and are not the result of physiological disorder."). 190. meyer, supra note 177, at 440. 191. seetorcasiov. mwtay, 57f.3d 1340, 1354(4thcir.1995)(reviewingcaselawfind­ ing obesity not covered by the ada); see whaley v. s.w. student transp., l.c., 2002 u.s. dist. lexis 9103, 10 (d. tex. 2002) (holding that obesity is not a disability because it is not a physical or mental impairment that substantially limits a major life activity); see marc a. koo­ nin, avoiding claims of discrimination based on personal appearance, grooming, and hy­ giene standards, 15 lab. law. 19, 33-34 (1999) (noting that california, pennsylvania, 2009] health should not be a determinative factor 159 a few courts have ruled that obesity alone may constitute a handicap. cookv. rhode island department of mental health, retardation, and hospit­ als192 was the first significant weight-discrimination case to reach the federal court of appeals.193 the first circuit held it was inappropriate under the reha­ bilitation act for an employer to discriminate based on a prospective em­ ployee's morbid obesity.194 the court did not hold that morbid obesity itself constituted a disability. rather, the court held that because the jury could rea­ sonably conclude that the employer perceived that obesity impaired the plain­ tiffs life by limiting mobility and had subsequently refused her employment, the perceived disability prong of the rehabilitation act was satisfied.195 other courts have adopted positions that are inconsistent with cook v. rhode island. the "second and sixth circuits have both held that obesity, standing alone, cannot constitute a disabling impairment without some further underlying physiological disorder."196 this shows that the ada should be available for a person who is "obese enough to require accommodation or who is actually sufficiently impaired to fall within the statutory definition of disabili­ ty. however, for those who suffer weight-based discrimination at lower levels of obesity or impairment, the ada does not, cannot, and probably should not provide a sufficient remedy. "197 c. equal protection under the fourteenth amendment not allowing obese individuals to adopt due to factors beyond their con­ trol could implicate the equal protection clause of the fourteenth amendment because such a regulatory constraint would disproportionately impact the ob­ ese.198 in order to succeed on an equal protection claim, a plaintiff would need to show both that the burden of an imposed regulation -such as evaluating prospective parents based on their weightfalls disproportionately on obese individuals, 199 and that the lawmakers intended that disproportionate impact. 200 alternatively, the plaintiff would have to show that the obesity regulation de­ prives him or her of a fundamental right or that it creates a suspect class of obese individuals.201 if a plaintiff could make a prima facie showing of either of these alternamissouri, north dakota, and new york courts have ruled that obesity alone is not a disability). 192. cook v. r.i. dep't of mental health. retardation, and hosps., 10 f.3d 17 (1st cir. 1993). 193. theran, supra note 105, at 183. 194. cook, 10 f.3d at 28. 195. id. at 23. 196. theran,supranote 105,at 184. seefrancisv. cityofmeriden, 129f.3d281,286 (2d cir. 1997); andrews v. ohio, 104 f.3d 803, 810 (6th cir. 1997). 197. theran, supra note 105, at 189 (footnote omitted). 198. see u.s. const. amend. xiv,§ 1. 199. see generally washington v. davis, 426 u.s. 229,239-41 (1976)(discussingthedual requirements of disproportionate impact and discriminatory legislative intent). 200. ld. 201. theran, supra note 105, at 174. 160 indiana hbal1h law review [vol. 6:137 tives, the regulation would warrant the strictest standard ofreview.202 under strict scrutiny, the regulation would be constitutional if a court determines that the regulation is necessary to accomplish a compelling state goal. 203 as shown earlier, however, adoption is a privilege afforded by statute and is not a funda­ mental right;204 strict scrutiny would therefore not be warranted. also, obese individuals have not been identified as a suspect class, and such regulations would thus not gamer strict scrutiny.205 the state action requirement of the fourteenth amendment means that such suits could only be sustained against either governmental or quasi­ governmental entities.206 purely private conduct does not fall underneath the fourteenth amendment.207 in the case of the prospective adoptive parents, a court's denial of an adoption satisfies the state action requirement. "even when the defendant is a state actor, under the fourteenth amendment, discriminatory policies that do not deprive someone of a fundamental right, create a suspect or quasi-suspect classification, or operate to disadvantage a suspect or quasi­ suspect class only receive the mildest standard of review: rational basis re­ view."208 under rational basis review, courts generally uphold as constitutional any regulation that is rationally related to a legitimate government interest or public purpose. 209 rational basis review is a "sliding scale, dependent upon whether the class affected is a protected class and whether the interest advanced by the state is a legitimate one.'mo because weight or appearance is not a sus­ pect ... classification, under the current state of the doc­ trine the discriminatory policy would merely have to be conceivably rationally related to a legitimate governmen­ tal interest in order to pass constitutional muster-a test that, in practice, almost always amounts to little more than a rubber stamp. 211 the government may support the prevention of adoption by obese people by asserting that obesity plays a significant role in chronic diseases. since one purpose of government is to promote the safety and welfare of its citizens,212 it 202. id. 203. id. 204. turbe, supra note 27 at 372. 205. theran, supra note 105, at 174. 206. /d. 207. /d. 208. id. 209. id. 210. byrd,supranote 167,at344. 211. theran, supra note 105, at 174. 212. see u.s. const. amend. x. 2009] healrn should not be a determinatne factor 161 might impede this legitimate interest to permanently place a child in a home where one of the parents is at a heightened risk for severe health complications or possibly death. the state agency could rationally assert that such a place­ ment would not be the best for the adopted child's welfare. opponents to the policy or practice of denying prospective adoptive par­ ents based on their weight could assert that obesity is an individual, not a pub­ lic, problem. government regulation in this area infringes on individual freedoms and personal responsibility. a person's weight does not indicate whether they will be a suitable parent.213 in addition, weight is not always an accurate indicator of health. 214 it is not possible to assess an individual's over­ all health by looking at only at the person's weight. 215 despite the contentions of the opposition, it is likely that a court would fmd that a legitimate state interest is advanced by agencies placing children on­ ly with parents who are deemed to be "healthy." medical studies have proven a link between obesity and heightened health risks, including premature death.216 therefore, it is rational for the state to want to ensure that the adoptive parents will be able to raise and care for the adopted children into the future; thus preventing the children from later becoming wards of the state. d. state claims at the state level, the situation is often not much better for the weight­ based discrimination plaintiff. michigan is the only state, along with the dis­ trict of columbia, that has antidiscrimination statutes that directly address weight-based discrimination.217 "[i]n all other states, weight-discrimination plaintiffs must bring suit under the state constitution or state human rights or public accommodations laws."218 michigan's statute, the elliott-larsen civil rights act ("act"),219 applies to weight-based discrimination within the contexts of contracts and employ­ ment. 220 the act has "more lenient standards than the ada or the rehabilita­ tion act in that a plaintiff does not have to prove that illegitimate criteria, such as weight or size, were the sole reasons or even the main reason for the termina­ tion. "221 the defendant has greater responsibility because the defendant has the 213. see supra part ii section e. 214. see supra part iv section d. 215. /d. 216. kenneth f. adams et al., overweight, obesity, and .mortality in an large prospective cohort of persons 50 to 71 years old, 355 n engl. j. meo. 763, (2006). 217. theran, supra note 105, at 173. michigan's civil rights law includes height and weight as prohibited forms of discrimination. mich. comp. laws § 3 7.2102 (west 2001 ). the district of columbia added personal appearance and sexual orientation to its list of discrimina­ tory factors. d.c. code § 2-1401.01 (2007). 218. theran, supra note 105, at 173 (footnote omitted). 219. mich. comp. laws ann.§§ 37.2101-37.2804 (west 2001 & supp. 2008). 220. /d. 221. meyer, supra note 177, at 444. 162 indiana health law review [vol. 6:137 burden to state a non-discriminatory reason for its action once the plaintiff lays out a prima facie case of discrimination based on size.222 "a plaintiff can estab­ lish a prima facie case by showing that '(1) she is a member of a statutorily pro­ tected class; (2) that she was qualified for the job; (3) that she was discharged from the job; and ( 4) that she was replaced by someone outside the protected group. "'223 this statute is significant because it exemplifies the possibility of developing and passing legislation that protects obese individuals from unjust discrimination. vi. comparing weight to 01her heal til choices/characteristics if courts are permitted to apply the best interests of the child standard to a prospective adoptive parent's weight-which is a health characteristic and argua­ bly a health choice-it would be interesting to compare how courts have treated parents who ( l) have a certain deleterious health characteristic, such as hiv or aids, or (2) have made other health choices, such as choosing to smoke. if courts are truly concerned about the best interests of the child, no child should be placed in any environment where the adoptive parent is at risk due to a health choice or characteristic, regardless of whether that risk is voluntarily as­ sumed or acquired. a. comparing weight to smoking it is unreasonable to dispute that smoking is bad for a person's health. smoking can exacerbate or lead to several diseases, including chronic obstruc­ tive pulmonary disease, lung cancer, osteoporosis, and periodontal disease, just to list a few. 224 it is also commonly known that parents who smoke expose their children to the risks of secondhand smoke. exposing children to secondhand smoke can cause respiratory problems, ear infections, more frequent and severe asthma attacks, and puts infants at risk for sudden infant death syndrome ("sids").225 researchers from the department of pediatrics at the university ofwisconsin medical school reported that "[a]t least 6,200 children die each year in the united states because of their parents' smoking, killed by such things as lung infections and bums."226 according to the surgeon general of 222. !d. 223. !d. at 445 (quoting penzato v. cont'l cablevision ofmich., inc., 1996 mich. app. lexis 1067, at *4 (mich. ct. app. 1996)). 224. see american council on science and health, the scoop on smoking, health effects, http://thescooponsmoking.org/xhtm1/effectshome.php (last visited march 12, 2009). 225. u.s. dept. of health and human services, the health consequences of involuntary exposure to tobacco smoke: a report of the surgeon general, u.s. department of health and human services (2006), available at http://www.surgeon general.govllibrary/secondhandsmoke/factsheets/factsheet2.html (last visited march 12, 2009). 226. guggenheim, supra note 54, at 316. parents warned on smoking, n.y. times, july 15, 1997, at c2 (citing c. andrew aligne, md & jeffi'ey j. stoddard, md, tobacco and 2009] health should not be a determ1native factor 163 the u.s. department ofhealth and human services, "there is no risk-free level of secondhand smoke exposure" and even short periods of exposure can be dangerous. 227 in 1993, the america bar association ("aba'') committee drafted a reso­ lution that aimed to protect children from the many risks and dangers associated with exposure to secondhand smoke. 228 one of the aba committee's recom­ mendations was to "make parental smoking habits a factor to be considered in custody determinations. "229 the aba committee also proposed mandating states to consider the smoking habits of prospective adoptive families as part of their placement decision. 230 although it is not mandatory, courts are beginning to apply the best inter­ est of the child standard to determine whether a child should be placed in a home where a parent smokes. 231 parental smoking is one factor that the courts consider when applying the best interests of the child standard. courts may even place more weight on parental smoking habits when a child has existing health problems that could be exacerbated by exposure to secondhand smoke.232 there are several child custody cases that show how some courts are choosing to address parental smoking. for example, in unger v. unger,233 the court held that ''the fact that a parent smokes cigarettes is a permissible parental habit to consider when determining what is in the best interests of the children because it may affect their health and safety. ,.234 more recently, the court in in re julie anne, 235 described secondhand smoke as a ''real and substantial dan­ ger"236 because it can cause and exacerbate illnesses, especially in children. this "danger is both a relevant factor and physical health factor that a family court is mandated to consider under the statute.'.237 trial courts do not abuse its discretion in protecting the children from being exposed to secondhand smoke.238 similarly, the focus of the court in lizzio v. lizzio was on secondhand cigarette smoke. 239 that court went on to opine that ''we are at a point in time when ... a parent or guardian could be prosecuted successfully for neglecting his or her child as a result of subjecting the infant to an atmosphere contaminated children: an economic evaluation of the medical effects of parental smoking, 1997 archivesofpedia1rics&aoolescentmed. 643,651 tbl. 2). 227. u.s. dept. of iiealmand human servs., supra note 225. 228. guggenheim, supra note 54, at 316. 229. id. 230. id. 231. cori s. annapolen, maternal smoking during pregnancy: legal responses to the public health crisis, 12 va. j. soc. pot'y & l. 744, 756 (2005) 232. id. 233. unger v. unger, 274 n.j. super. 532 (1994). 234. 'lu·. at 538. 235. in re julie anne, 121 ohio misc.2nd 20 (2002), 780 n.e.2d 635 (2002). 236. id. 237. id. 238. day v. day, 2005 ohio 4343, (2005). 239. lizzio v. lizzio, 162 misc. 2d 701 (n.y. 1994). 164 indiana health law review [vol. 6:137 with health-destructive tobacco smoke . ..240 this judge classifies cigarette smoke much more seriously than the majority of family law judges, butit does indicate that some judges are beginning to consider secondhand smoke as an important health factor in custody cases, especially when a child has been diag­ nosed with a respiratory condition, such as asthma. 241 other courts are applying battery jurisprudence242 to secondhand smoke, which shows that courts consider smoking to be harmful contact in other situa­ tions outside of the realm of custody battles. 243 in leichtman v. wlw jacor communications, inc., an anti-smoking advocate was scheduled to appear on a radio talk show to talk about the dangers of smoking and secondhand smoke.244 during his time in the studio, the host lit a cigar and blew smoke in the advocate's face several times. 24s the advocate sued the host for damages, claiming that the host's intentional act qualified as a battery and the court ruled in the advocate's favor.246 even though it is well established that exposure to secondhand smoke is harmfulthousands of children are put at risk and die from secondhand smoke every yeac47 -there have been no publicized accounts of prospective adoptive parents not being permitted to adopt because they choose to smoke. is living with a parent who smokes, biological or adoptive, truly in the best interests of the child? if courts and judges are going to put more emphasis on the health factor, then smoking needs to be given at least, if not more, consideration as a factor than weight for the following four reasons. first, obesity poses less risk to the child than being exposed to secondhand smoke. there is a conscious individual choice with smoking, as opposed to becoming obese, which may be influenced by genetics. in addition, exposing a child to secondhand smoke could give rise to a battery action against the parent, where there is no such risk with obesity. lastly, smoking is not essential to surviving, but one must eat in order to live. first, obesity does not pose the same threat to other individuals like the negative effects of smoking.248 the effects of secondhand smoke on other indi­ viduals living in the same house pose more of a risk and have more serious ef­ fects than having a parent who may be obese or overweight. although both lifestyles are unhealthy and pose risks to the individual who is choosing to smoke or who is overweight, only smoking directly impacts those living in the 240. id. at 705. 241. id. at 705-06. 242. elements ofbattery: (a) the defendant acted with the intent to cause a harmful or of­ fensive contact, and that (b) the contact actually occum:d. leichtman v. wl w jacorcommuni­ cations, inc. 634 n.e.2d 697,698 (ohio ct. app. 1994). 243. id. 244. id. 698. 245. id. 246. id. 247. guggenheim, supra note 54, at 316. 248. catlin, supra note 150, at 1096-97. 2009] health should not be a determinatne factor 165 same house in a negative way on a daily basis. having a parent who is obese may be inconvenient at times, but obesity alone is not a direct threat to the wellbeing and health of the children. 249 second, an individual makes a conscious choice to begin smoking while there is scientific evidence that shows that weight may be caused or greatly in­ fluenced by genetics. once an individual chooses to smoke, it can become an addiction, but the individual makes the initial decision on whether to pick up the cigarette. a person struggling with obesity has often been dealing with weight issues since childhood and did not really make the choice to become obese. there are a variety of diets and treatments available to help overweight individuals to lose weight, if they choose. the original choice to become over­ weight, however, is often not a conscious one made by the obese person. third, according to the court in leichtman, blowing smoke in the face of another person may constitute battery, 250 which could feasibly extend to biolog­ ical or adoptive parents who expose their children to secondhand smoke. putting children in a home where they may be "battered" is definitely not in their best interests. obesity has not been subject to the same battery analysis as smoking. children placed in a home with an obese parent are not at risk ofbe­ ing "battered" in the same way as someone living in the home where one or more of the parents choose to smoke. lastly, smoking is not a necessity, whereas eating is essential to survival. a person who is addicted to nicotine may feel very compelled to smoke due to the addition, but it is not an absolute necessity for life. all people, even those who are overweight, must eat a certain amount of food to live. ultimately, if courts are going to consider the health choices and characte­ ristics of prospective adoptive parents, more emphasis should be placed on oth­ er negative health choices, such as smoking. choosing to smoke is a proven and serious risk to others, is entirely by choice, and is not necessary in order to live. courts should not be able to single out one health characteristic, such as weight, when making their determination, especially when they are not empha­ sizing other choices that pose much more serious risks to the child. b. comparing weight to hiv and aids unlike smoking, coping with hiv or aids is not a choice because there is currently no cure once it is contracted. courts are not consistent in their de­ cisions regarding parents and prospective adoptive parents who have hiv or aids.251 john tv. carraher252 is one of the first cases that dealt with an attempt to remove a foster child from the foster parents who desired to adopt him because 249. see supra part iv, section d. 250. leichtman, 634 n.e.2d at 698-99. 251. see supra part v section b. 252. john t.v. carraher, 538 n.w.2d 761 (neb. ct.app. 1995). 166 indiana health law review [vol. 6:137 the foster mother was infected with aids.253 the child was three and a half years old and had been placed with the foster parents as part of a "fos-adopt" placement, meaning that the placement was assumed to be permanent with an adoption to occur at some point in the future. 254 when the foster parents ap­ plied to be "fos-adopt" parents, they were aware that the mother was hn posi­ tive but did not disclose that fact to the department of social services (dss). 255 after dss became aware that the foster mother was infected with hn, dss requested a change in placement for john.256 when questioned as to the rea­ sons for the change in placement, a dss spokesperson responded that it would be difficult for john to lose his adoptive mother at a young age.257 the foster parents sued the state, alleging a violation of the rehabilitation act by exclud­ ing the mother from participating in the state's foster care and adoption pro­ grams based on her hn status. 258 eventually the court allowed the foster couple to adopt the child, but sadly, the foster mother died from aids one month before the adoption was fmalized. 259 mcnicholas v. johnson260 is another case where the parents wishing to adopt a child have been diagnosed with hn. 261 in that case, johnson chose relatives, mr. and mrs. mcnicholas, to be the adoptive parents ofher baby girl and they agreed to become the girl's parents. 262 the department of public welfare prepared an adoption summary report as part of the adoption process and disclosed that mr. and mrs. mcnicholas were infected with hn and were expected to develop aids within the next year or two; therefore, they would be unable to care for the child. 263 the mcnicolases also suffered from other phyiscial ailments.264 mr. mcnicholas had been diagnosed with encephalitis, was on medication to help him sleep, and used an inhaler to prevent him from contracting pneumonia.265 mrs. mcnicholas had contracted a non-hodgkins lymphoma and undergone chemotherapy.266 johnson wrote a letter to the court expressing her concerns about the prospective adoption and requested that the court not permit mr. and mrs. mcnicholas to adopt her biological child. 267 in order for a biological mother to withdraw her consent to an adoption, she has the burden of establishing that she 253. ld. at 762. 254. ld. at 765. 255. ld. 256. id. at 766. 257. ld. 258. doe v. nebraska, 345 f.3d 593 (2003). 259. plager, supra note 39, at 623. 260. mcnicholas v. johnson, 612 n.e.2d 569 (ind. ct. app. 1993). 261. ld. 262. ld. at 570-571. 263. ld. at 571. 264. ld. 265. ld. 266. mcnicholas, 612 n.e.2d at 571. 267. ld. 2009] health should not be a determinative facfor 167 is acting in the best interest of the child. 268 in this case, the court allowed john­ son to withdraw her consent because it was not in the child's best interest to be orphaned at a later date. 269 there are several problems with the court's decision in mcnicholas v. johnson. first, the court did not take any evidence from mr. and mrs. mcni­ cholas or from their doctor about their ability to care for the child. 270 there is a complete lack of credible medical evidence about the nature ofhn and aids, the various available treatments, the present health condition of mr. and mrs. mcnicholas, or their future prognosis.271 second, the court assumes that if the couple develops aids, they will be unable to care for the child, despite evi­ dence that there was a strong family support system and a much older son of the couple that would be able to care for the child.272 currently, it is widely accepted that a prospective adoptive parent with hn or aids will not pose a transmission risk to the child, but is a court still going to consider hn or aids as a significant factor during the best interest of the child analysis? if courts and judges are going to emphasize the health of the prospective parents as a factor, then hn and aids need to be given at least the same consideration as weight as a factor for the following reasons. first, although there are several medications that prolong life or extend the period before hn develops into aids and treatments are becoming more ad­ vanced, there is no cure for aids. 273 highly active antiretroviral therapy ("haar t'') is a combination therapy of azidothymidine ("azf''), nonnucleo­ side reverse transcriptase inhibitors, and protease inhibitors. 274 as haar t treatments become more commonly prescribed, aids-related deaths have been significantly reduced. 275 while there are various treatments for obesity, includ­ ing surgery and lifestyle changes, the amount of success varies from person to person.276 second, it is not possible to predict how long a person with aids has to live, just like it is also not possible to accurately predict the number of years that an obese person has to live. advanced drug therapies have extended the life of persons with aids to the point where some people call it a chronic dis­ ease. 277 likewise, an obese person may live for decades, although premature 268. /d. at 573. 269. /d. 270. /d. at 578 (sharpnack, j., dissenting). 271. /d. at 573. 272. mcnicholas, 612 n.e.2d at 575 .. 273. aids.org, fact sheets: background information. 101: what is aids?, http:// www.aids.org/factsheets/1 01-what-is-aids.html (last visited march 12, 2009). 274. jody marcucci, doe v. county of centre: foster children, aids, the americans with disabilities act, and the direct threat exception, 52 depaull. rev. 945, 949 (2003). 275. /d. 276. web md, healthy eating & diet: obesitytreatment overview, http://www. webmd.com/diet/tc/obesity-treatment-overview (last visited march 12, 2009). 277. aids.org, frequently asked questions, http://www.aids.org/info/do-drugs-cure­ aids.html (last visited march 12, 2009). 168 indiana heal til law review [vol. 6:137 death is one of the health risks associated with the health condition. 278 third, unlike smoking, people do not choose to contract hiv or to be­ come obese. most people are not aware of the precise moment when they con­ tract hiv and may not find out until years later when symptoms begin to appear.279 scientific studies show that weight is highly influenced bls genetics and the environment and may not be a real choice for some people. 80 fourth, the risk oftransmission ofhiv between members of the same household is low.281 dr. morin, a specialist in infectious diseases who treats hiv and aids patients, testified in john t. v. carraher that transmission to household members who are not sexual partners is a risk which is "miniscule, at best."282 likewise, even though weight may have a genetic component, there is not a risk of transmitting the "obesity'' gene from an adoptive parent to his or her adopted child. lastly, hiv and aids are considered disabilities and are protected status­ es under the ada;283 therefore, people with hiv or aids cannot be discrimi­ nated against. 284 since both are protected statuses, courts would not be permitted to use either health characteristic as a determinative factor in whether a prospective adoptive parent with hiv or aids would be allowed to adopt. on the other hand, weight is not a protected status, and it is possible for courts to deny prospective adoptive parents on this basis alone.285 for the reasons explored above, the issue of weight is more similar to hiv or aids than smoking. a parent who is obese or infected with hiv or aids poses little risk to a child as opposed to a parent who exposes a child to second­ hand smoke. being obese or infected with hiv will not give rise to a battezy action, unlike being exposed to secondhand smoke. smoking tends to be a con­ scious, individual choice, but few people choose to become obese or infected with hiv. courts are not allowed to use hiv or aids as a determinative factor in whether a prospective adoptive couple will be permitted to adopt and should evaluate an obese adoptive couple under a similar framework. vll. conclusion in conclusion, each child deserves a permanent home and the love and support that committed parents can provide. courts should evaluate all pros278. web md, supra note 276. 279. aids. oro, supra note 277. 280. see supra part iv section a. 281. aids.org, supra note 277. 282. john t.v. carraher, 538 n.w.2d 761, 765 (neb. ct.app. 1995). · 283. a person qualifies as an "individual with a disability" if she can show that she either (1) has a ''physical or mental impairment that substantially limits one or more major life activi­ ties," (2) has a ''record of' such an impairment, or (3) is "regarded as having such an impair­ ment." 42 u.s.c. § 12102 (2000). 284. marcucci, supra note 274. 285. see supra part v. 2009] health should not be a determinative factor 169 pective adoptive parents based upon their individual character and ability to parent, not merely on their physical characteristics. and limitations, such as weight in the end, what defines a parent as a parent is their ability to provide ethical, emotional, and intellectual guidance to that child and not whether the parent is dealing with a particular health characteristic, such as obesity. "all states should adopt the child welfare league of america's standard against discrimination as a practice in adoption proceedings and investiga­ tions"286 in an effort to work towards a nondiscriminatory evaluation process. "according to the child welfare league of america, •[a]pplicants should be accepted on the basis of an individual assessment of their capacity to under­ stand and meet the needs of a particular available child at the point of the adop­ tion and in the future. "'287 hopefully this will be one step closer to helping all children fmd stable homes and loving parents, like annie found in oliver war­ bucks.288 286. mabry, supra note 64, at 324. 287. id. (citing fi:om child welfare league of america, standards ofexcellence for adop­ tion services, p 4. 7 (2004)). 288. annie, supra note 1. 510(k) clearance: opportunities to incentivize medical device safety through comparative effectiveness research 510(k) clearance: opportunities to incentivize medical device safety through comparative effectiveness research amanda swanson* abstract......................................... 117 i. introduction................................... 118 ii. federal regulation of medical device safety and efficacy .................................. ...... 120 a. history ............................. ...... 120 b. fda regulation ....................... ..... 129 1. rulemaking and guidance. ........ .......... 129 2. reporting and postmarket surveillance ... ..... 134 3. enforcement powers.... ................... 142 a. administrative .............................. 142 b. judicial................................ 145 c wh en the regulatory process fails: the tort system ................................... 147 iii. proposals to fix the flaws in the system............. 152 a. institute of medicine: a new regulatory system for 510(k) devices ........................ ..... 152 b. use of comparative effectiveness research by the government as payer... .................... 156 iv. conclusion ............................... ..... 172 abstract the food and drug administration's 510(k) clearance process, which clears medical devices for marketing based on their similarity to devices already available on the market, has remained almost entirely unchanged since its creation in 1976. thirty-five years later, the institute of * amanda swanson is an illinois licensed attorney and received her ll.m. in health law and j.d. from loyola university chicago school of law. she currently works for the city of chicago department of law, and can be reached at aeswans@gmail.com. indiana health law review medicine was charged with evaluating this process, and concluded that it does not sufficiently protect patients from unsafe medical devices. although the iom proposed creating a new regulatory framework utilizing more premarket and postmarket evaluation of scientific evidence of safety and effectiveness, the feasibility of this is limited by the fda's resource constraints. instead, this article proposes that the best solution is for the federal government, in its capacity as payer, to use comparative effectiveness research in its coverage determinations. this would maintain the efficiency of the 510(k) clearance process without sacrificing patient safety, while also shifting the responsibility for increased surveillance of 510(k) devices from the fda to other agencies, fostering innovation and keeping the u.s. a competitive market in the medical device industry. i. introduction after a string of adverse events resulting from the use of faulty heart-defibrillator wires,' three senators, on march 15, 2012, introduced a bill in congress that aims to improve the food and drug administration's (fda) oversight of medical devices, entitled the ensuring safe medical devices for patients act. 2 this bill intends to accomplish this through increasing postmarket surveillance and risk identification of medical devices, and also creating a unique device identification system, which would require implantable devices to carry a unique number that could be used to track the device through the distribution chain.3 the goal is to protect patients and ensure that unsafe 1 see thomas burton, fda in hot seat on safety-* doctors want agency to better gauge risks of heart devices, wall st. j., apr. 9, 2012, http://online.wsj.com/article/sb10001424052702303772904577333 941715666550.html (last visited nov. 25, 2012). 2 ensuring safe medical devices for patients act, s. 2193, 112th cong. (2012), available at http://www.gpo.gov/fdsys/pkg/bills-112s 2193is/pdflbills1 12s2193is.pdf. 3 id. at § 2. 118 vol. 10:1 510(k) clearance and/or defective devices can be quickly identified and the products removed from the market. 4 doctors are also pushing for increases in reporting requirements for medical devices, and the fda has revealed plans to improve their safety monitoring programs.5 it seems there is a consensus that more can be done to ensure the safety of medical devices available in the united states market. even in light of this awareness, one aspect of medical device regulation has remained almost entirely unchanged since its creation in 1976: the 510(k) clearance process. through this process, devices are cleared for marketing (not granted an approval based upon considerations of safety and effectiveness) based on their clinical similarity to devices already available on the market at the inception of this process.6 in september 2009, the fda charged the institute of medicine (iom) with reviewing this clearance process and determining if it optimally promotes innovation while protecting the public's health, and if not, what changes would improve the process' ability to achieve these goals.7 this article will provide an overview of. the fda's current regulatory and approval processes for medical devices and will discuss the determinations made by the iom in its evaluation of the 510(k) clearance process. then the recommendations presented in the iom report and their likelihood to succeed in improving patient safety will be 4 press release, office of senator jeff merkley, senators introduce bipartisan effort to make medical devices safer: the ensuring safe medical devices for patients act would implement long overdue reforms and help save lives (march 15, 2012), available at http://www.merkley.senate.gov/newsroom/press/release/?id=63dd8e2dbf9a-491c-bfc2-0a33a5096bf7 (last visited nov. 25, 2012). the unique device identification system was authorized by the fda amendments act of 2007, but it has yet to be implemented. fda amendments act of 2007, pub. l. no. 110-85, § 226, 121 stat. 823, 854 (2007), available at http://www.gpo.gov/fdsys/pkg/plaw-110publ85/pdf/plaw-11opubl85. pdf. 5 burton, supra note 1. 6 inst. of med., medical devices and the public's health: the fda 510(k) clearance process at 35 years 15 (2011) [hereinafter iom report]. 7 id. at 16. 2013 119 indiana health law review analyzed. finally, this paper will conclude that, although the iom's recommendations will provide a large step in the right direction, more must be done to ensure the safety of the medical devices on the market. it will be proposed that the best way to ensure the safety and efficacy of medical devices is for the federal government, in its capacity as payer under federal health programs, to compare the effectiveness of devices and medical interventions already available to new devices ready to enter the market and use this information in determining whether or not devices will be covered under either program. in this way, the u.s. will not fall behind other nations with regard to availability of cutting edge technologies in medicine by overburdening the fda with extensive evaluations of devices. instead, device manufacturers and patients both will benefit from prompt availability of reasonably safe medical devices, the assured continuation of research into the comparative effectiveness of new devices, and the availability of this information to guide medical decision making and ensure patients receive the safest and most effective treatments available. ii. federal regulation of medical device safety and efficacy a. history the first significant action of congress in the realm of public health and safety occurred in 1906 when it passed the pure food and drug act.8 this act prohibited the manufacture and interstate shipment of adulterated, misbranded, or harmful foods, drugs, and liquors.9 in 1938 federal regulation was expanded to cover misbranded or adulterated cosmetics and medical devices as well through the passage of the federal food, drug and cosmetic act (fdca).1o the fdca prohibited the adulteration or 8 the federal food and drugs act of 1906, 21 u.s.c. § 1 (repealed 1938). 9 id. 10 the federal food, drug and cosmetic act of 1938, 21 u.s.c. § 301 (1938). 120 vol. 10:1 510(k) clearance misbranding of medical devices, and gave the fda authority to inspect manufacturers of medical devices." however, although the fdca established a premarket approval process based on evaluations of safety for drugs, it did not regulate the ability of new medical devices to enter the market. instead, the fda could only seize dangerous devices on the market and rely on injunction actions to prevent dangerous devices from returning to the market. 12 for many decades this act and its corresponding regulations constituted the parameters of federal oversight of the medical device industry. in the 1970s several devices began to draw the attention of patients, the fda, and congress to the possible health risks of medical devices.13 in response to these concerns, congress passed the medical device amendments (mda) to the fdca.14 the mda sets out three categories of medical devices, and classifies them based on the risk they pose to the public. class i devices are those which present no "unreasonable risk of illness or injury," and are subject only to general regulatory controls15 such as regulations pertaining to good manufacturing practices, labeling, and adverse experience reporting (discussed in greater detail below).16 class i devices include hand held surgical instruments, latex gloves, and bandages.' 7 class ii devices present more risk than class i, and as a consequence are subject to special controls which include the "promulgation of performance standards, postmarket surveillance, patient 11 nancy w. mathewson, history of medical device regulation, in medical device regulation & compliance 1, 1 (stephen d. terman & neil f. o'flaherty eds., 2010), available at http://www.fdli.org/pdf/ pubs/fdli-medical-device.pdf. 12 id. 13 medtronic, inc. v. lohr, 518 u.s. 470, 475-76 (1996). 14 the medical device amendments, 21 u.s.c. § 360c (2012). 15 21 u.s.c. § 360c(a)(1)(a)(ii)(ii) (2012). 16 robert b. leflar & robert s. adler, the preemption pentad: federal preemption of products liability claims after medtronic, 64 tenn. l. rev. 691, 721 (1997). 17 medical devices: general and special controls, u.s. food and drug admin., http://www.fda.gov/medicaldevices/deviceregulationand guidance/overview/generalandspecialcontrols/default.htm (last visited nov. 25, 2012) [hereinafter general and special controls]. 2013 121 indiana health law review registries, development and dissemination of guidelines" and any other actions deemed appropriate by the secretary of the department of health and human services.18 examples of class ii devices include surgical drapes, powered wheel chairs,' 9 and tampons.20 the last class of devices, class iii, are those that present the most risk to patients and are intended for use in supporting or sustaining life. 21 examples of class iii devices include pacemakers, 22 orthopedic bone screws, 23 and catheters. 24 the fda regulates the manufacture of all devices through what are known as quality system regulations, current good manufacturing process (gmp) requirements, postmarket surveillance, and adverse experience reporting. 25 these regulations require the manufacturer of the device to establish and maintain procedures able to prevent contamination of the equipment and products by sub-stances that could have an adverse effect on device quality and safety. 26 additionally, each manufacturer must also implement processes to test the products for compliance with the product specifications (established and maintained by the manufacturer, subject to verification and/or validation by the fda as appropriate to ensure device safety27), to identify and control nonconforming products, and to document such compliance before the products are sold or used.28 class i and class ii devices, because they present little risk of illness or injury, are subject to only these general regulatory controls of safety and 18 21 u.s.c. § 360c(a)(1)(b) (2012). 19 general and special controls, supra note 17. 20 nat'l bank of commerce v. kimberly-clark corp., 38 f.3d 988, 990 (8th cir. 1994) (citing 21 c.f.r. §§ 884.5460, 884.5470 (2012)). 21 21 u.s.c. § 360c(a)(1)(c) (2012). 22 general and special controls, supra note 17. 23 buckman co. v. plaintiffs legal comm., 531 u.s. 341, 344 (2001). 24 riegel v. medtronic, inc., 552 u.s. 312, 320 (2008). 25 general and special controls, supra note 17. 26 21 c.f.r. § 820.70(e) (2012). 27 21 c.f.r. § 820.70(b) (2012). 28 21 c.f.r. §§ 820.72-820.90 (2012). vol. 10:1122 510(k) clearance effectiveness. 29 consequently, there are no federal regulations of design or manufacture for class i or ii devices.30 class iii devices are treated quite differently, however, and require extensive evaluation and approval of their safety and efficacy, while also being subject to the same general regulatory controls. the mda provided that all post amendment devices were to be automatically classified as class iii, unless they met a specific exception.3' class iii devices are required to undergo a process of scientific review to ensure their safety and effectiveness before they are permitted to be marketed, known as premarket approval (pma).32 the application for plvia is lengthy, and manufacturers must submit detailed information regarding the safety and efficacy of their devices. specifically, the fda requires that the applicant document descriptions, investigations, and other relevant information pertaining to the safety and efficacy of the device for which approval is sought.33 the application must include a full description of the device, its components, how it works, and its indications for use, as well as the methods used in the manufacture, processing, packaging, and installation of the device. 34 additionally, information regarding the proposed labeling, investigations, and directions for use must also be included.35 a pia, if granted, will be based on 29 21 u.s.c. § 360c(a)(1)(a)(ii)(ii) (2012). 30 as a general matter, the fda does have the authority to impose specific regulations pertaining to manufacture or labeling, instruction or warning if it determines the safe use of a class i or ii device requires it. see section ii(b)(1) below for a discussion on these regulations. see also, e.g., 21 c.f.r. § 801.430 (2012) (warning requirements for tampons). 31 iom report, supra note 6, at 86. devices were not classified as class iii if they were on the market prior to the enactment of the mda or were substantially equivalent to devices on the market at that time, 21 u.s.c. § 360c(f)(1) (2012), or the manufacturer of the device may petition for a reclassification of the device to class i or ii. 21 u.s.c. § 360c(f)(3) (2012). 32 21 u.s.c. § 360e (2012). 33 21 u.s.c. § 360e(c) (2012); 21 c.f.r. § 814.20 (2012). 34 21 u.s.c. § 360e(c)(1) (2012). 35 21 u.s.c. § 360e(c)(2)(a) (2012). 2013 123 indiana health law review considerations of all of this information, and may specify requirements the device must meet (based on the information provided, as relevant) to be marketed. 36 the safe medical devices act of 1990 gave the fda the authority to issue regulations which require pre-production design controls for medical devices, in order ensure the safety and efficacy of the device. 37 a class iii device that fails to meet the requirements specified in the p1ia will be considered adulterated under the fdca and cannot be marketed. 38 perhaps most importantly, the pma application must include a summary of both the nonclinical laboratory studies and the clinical studies involving human subjects, as well as the conclusions drawn from these studies regarding the safety and efficacy of the device. 39 the application also requires a clinical investigations section in which study protocols, safety and effectiveness data, adverse reactions, complications, device failures, patient information and complaints, and other clinical investigation information are disclosed. 40 it is essential that the demonstrations of safety and effectiveness of the device are founded on good science and good scientific writing; if such information is lacking, the fda will refuse to file the pma application. 41 fda regulations provide 180 days to review the pma and make a determination. 42 in practice, however, 86 medical devices: premarket approvals, u.s. food and drug admin., http://www.fda.gov/medicaldevices/productsandmedical procedures/deviceapprovalsandclearances/pmaapprovals/default.htm (last visited nov. 26, 2012). 3 center for devices and radiological health, alternate approaches to demonstrating substantial equivalence in premarket notifications: final guidance 3 (1998), available at http://www.fda.gov/downloads/medicaldevices/deviceregulationand guidance/guidancedocuments/ucmo80189.pdf. 38 id. 39 21 c.f.r. § 814.20(b)(3)(v)-(vi) (2012). 40 21.c.f.r. § 814.20(b)(6) (2012). 41 medical devices: premarket approval (pa), u.s. food and drug admin., http://www.fda.gov/medicaldevices/deviceregulationand guidance/howtomarketyourdevice/premarketsubmissions/premarketapp rovalpmaldefault.htm (last visited nov. 26, 2012) [hereinafter pal41. 42 21 c.f.r. § 814.40 (2012). vol. 10:1124 510(k) clearance the review time is normally longer.43 it has been reported that the fda spends "an average of 1,200 hours on each submission."44 although this review is detailed, there is some debate as to the effectiveness of this review process. 45 . to avoid this lengthy pma process, manufacturers can generally attempt to bring their device to market through one of three exemptions. the first, the investigational device exemption (ide),46 is available to manufacturers who want to test an experimental device on humans, or who want to test an already available device for use for a new indication.47 the manufacturer must obtain permission for these tests from both the fda and from the institutional review board (irb) of the institution at which the testing will be performed. 48 to obtain an ide, the applicant must submit to the fda information about the device and how the experiment will be conducted. 49 it is primarily upon this submission that the fda makes its decision, and approval does not involve a finding by the agency that the manufacturer has made correct decisions about the design, labeling, or production of the device under investigation.5 0 43 pam, supra note 41. 44 medtronic, inc. v. lohr, 518 u.s. 470, 477 (1996). 45 see, e.g., david brennan, federal preemption of all state law tort claims in riegel v. medtronic: a need to undo a serious wrong, 36 w. st. u. l. rev. 137, 161-64 (2009) ("pogo [project on government oversight] observed that the effect of the riegel decision by the u.s. supreme court was to nearly 'condone the notion' challenged repeatedly . . . that the 'fda 'spends an average of 1,200 hours reviewing each application ... and [it only] grants premarket approval only [where] it finds [that] there is a 'reasonable assurance' of the device's 'safety and effectiveness." independent of pogo and the fda's suggestions of a rigorous and robust application of the mda to its processes to prevent inadequately reviewed medical devices from entering the market place, there is credible and sufficient information . . . coming from the fda's own scientists, congressional lead-ers, nongovernmental organizations . .. and the general accountability office. . . to demonstrate substantial doubt as to the overall effectiveness of the agency in the sphere of class iii medical devices."). 46 21 u.s.c. § 360j(g) (2012). 47 leflar & adler, supra note 16, at 721-22. 48 id. at 722. 49 id. 50 id. at 722-23. 2013 125 indiana health law review ide devices are used under the supervision of the fda during the trial process and after, and the fda is able to then impose requirements on the device regarding design, manufacture, and safety.51 the requirements of the pma will be satisfied and the device will receive pma for broader use if the ide trials are able to prove the device is satisfactorily safe and effective. 52 a humanitarian device exemption (hde) is also available to exempt from the premarket approval process devices that are intended to benefit only very small patient populations through treatment in near-death situations. 53 this exemption can be used in situations where the required approval by an irb cannot be obtained in time to prevent serious harm or death to a patient. 54 the fda guidelines permit the use of the device in these circumstances for purely humanitarian purposes, and this permission is not intended to equate with a pma approval of the safety or efficacy of the device.55 neither the ide nor the hde exemptions will be addressed further in this article. a vast majority of devices are exempt from the pma approval process through something known as § 510(k) premarket notification. 56 the mda grandfathered in any devices that were legally on the market before may 28, 197657 and also permitted devices that were shown to be "substantially equivalent" to these pre-1976 devices58 to avoid the pma process through premarket notification. the manufacturer or sponsor of the device must receive an order from the fda finding the device to be substantially 51 burgos v. satiety, inc., no. 10-cv-2680 (jg), 2010 wl 4907764, at *2 (e.d.n.y. nov. 30, 2010). 52 id. (citing in re orthopedic bone screw prods. liab. litig., 193 f.3d 781, 786 (3d cir.1999)). 53 brennan, supra note 45, at 144. 54 id. s id. 56 jeffrey zigler et al., medical device reporting: issues with class iii medical devices, 62 food & drug l.j. 573, 573 (2007); see also medtronic, inc. v. lohr, 518 u.s. 470, 479 (1996). 57 21 u.s.c. § 360e(b)(1)(a) (2012). 58 21 u.s.c. § 360e(b)(1)(b) (2012). 126 vol. 10:1 510(k) clearance equivalent to a predicate device.59 this order clears the device for commercial distribution in the u.s.60 this 510(k) process was initially created as a way to keep the valuable medical device products consumers had used for years available on the market, and to prevent unfair monopolization of the marketplace by those manufacturers fortunate enough to get their products out before the enactment of the mda. however, the review process has taken a very different form today. only conceptually new devices marketed since 1976 have been required to undergo rigorous scientific demonstration of safety and efficacy.6' section 510(k) review requires the submission of comparably little information on the device, and the review is usually completed by the fda in twenty hours.62 the concept of substantial equivalence is central to the 510(k) clearance process. when the premarket notification was first created, the fda intended to ensure new devices cleared for marketing through this process did not differ from their predicate devices in a way that had an effect on 59 a predicate device is "a legally marketed device . . . that is not subject to premarket approval (pma)." fda, how to find a predicate device, http://www.fda.gov/medicaldevices/deviceregulationand guidance/howtomarketyourdevice/premarketsubmissions/premarket notification510klucm134571.htm. 60 medical devices: premarket notification (501(k)), u.s. food and drug admin., http://www.fda.gov/medicaldevices/deviceregulation andguidance/howtomarketyourdevice/premarketsubmissions/premarket notification5lok/default.htm (last visited nov. 26, 2012). 61 zigler, supra note 56, at 573. in 2007, the government accountability office (gao) began a study to determine which review process, 510(k) or pma, was used by the fda to review different types of device submissions. u.s. gov't accountability office, gao-09-190, medical devices: fda should take steps to ensure that highrisk device types are approved through the most stringent premarket review process 4 (2009). the gao found that, from 2003 to 2007, the fda reviewed 13,199 submissions for class i and ii devices through the 510(k) process and cleared 90 percent. id. at 6. the fda also reviewed 342 510(k) submissions for class iii devices, and cleared 67 percent of these. id. in contrast, 217 original and 784 supplemental submissions for class iii devices were reviewed through the pma process, and 78 and 85 percent, respectively, of these sub-missions were approved. id. 62 medtronic, inc. v. lohr, 518 u.s. 470, 479 (1996). 2013 127 indiana health law review the safety or efficacy of the device. in a guidance issued by the fda, the concept was described as follows: the term "substantially equivalent" is not intended to be so narrow as to refer only to devices that are identical to marketed devices nor so broad as to refer to devices which are intended to be used for the same purposes as marketed products. the committee believes that the term should be construed narrowly where necessary to assure the safety and effectiveness of a device but not narrowly where differences between a new device and a marketed device do not relate to safety and effectiveness. thus, differences between "new" and marketed devices in materials, design, or energy source, for example, would have a b[e]aring on the adequacy of information as to a new device's safety and effectiveness, and such devices should be automatically classified into class iii. on the other hand, copies of devices marketed prior to enactment, or devices whose variations are immaterial to safety and effectiveness would not necessarily fall under the automatic classification scheme. 63 as codified in the u.s. code, substantial equivalence means that either the device has the same technological characteristics64 as the predicate device, or the device has 63 guidance on the cdrh premarket notification review program, u.s. food and drug admin., http://www.fda.gov/ medicaldevices/deviceregulationandguidance/guidancedocuments/ ucm081383.htm (last visited nov. 25, 2012) (quoting h.r. rep. no. 94853, at 36-37 (1976)). 64 21 u.s.c. § 360c(i)(1)(b) (2012) ("[tlhe term 'different technological characteristics' means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device."). vol. 10:1128 510(k) clearance different technological characteristics but sufficient clinical data is provided to demonstrate it is as safe and effective as the predicate device. 65 the device also cannot raise different questions of safety and effectiveness than those raised by the predicate device.66 the concept of substantial equivalence can be read fairly broadly, particularly since the devices can be compared to a pre-1976 device or any device previously cleared through the 510(k) process.67 in effect, devices may be cleared for marketing because of a finding that they are as safe and effective as devices no longer in use.68 however, a device previously removed from the market by the fda or by a judicial order finding the device misbranded or adulterated may not be used as the predicate device in a determination of substantial equivalence.6 9 b. fda regulation 1. rulemaking and guidance one important way the fda increases the medical device industry's compliance with its regulations is through the issuance of rules and guidelines to clarify expectations. as industry participants become better informed and develop a greater understanding of their obligations, their ability to comply with them is improved; consequently, the need for enforcement of the regulations decreases. the administrative procedure act (apa) was enacted in 1946 to regulate and standard-ize agency actions and the 65 21 u.s.c. § 360c(i)(1)(a) (2012). 66 office of device evaluation, smda changes: premarket notification; regulatory requirements for medical devices (510k) manual insert (1992), available at http://www.fda.gov/ downloads/medicaldevices/deviceregulationandguidance/guidancedoc uments/ucmo81355.pdf. 67 how safe are medical devices., n.y. times, aug. 4, 2011, http://www.nytimes.com/2011/08/05/opinion/how-safe-are-medicaldevices.html?_r=1 (last visited nov. 26, 2012). 68 id. 69 21 u.s.c. § 360c(i)(2) (2012). 2013 129 indiana health law review rulemaking process. 70 rulemaking refers to the process by which administrative agencies, in following broad policy mandates enacted by the legislature through the passage of statutes, create regulations. regulations refer to rules and/or orders issued by an agency which have the force of law; that is, which compel action by imposing a legal requirement through the allocation of responsibilities or constraint of rights.7 ' the apa recognizes only three forms of rulemaking: formal (trial-like hearing), informal (notice and comment), and negotiated. 72 informal rulemaking is by far the most common, and affords the public notice of the proposed rule and the opportunity to respond and comment before it is enacted. 73 formal rulemaking is used by agencies only when a statute requires it, and the formal adjudication procedures laid out in the apa, which involve the submission of evidence and the opportunity for crossexamination, must be followed. 74 the fdca requires the fda to follow formal rulemaking procedures before issuing a rule.75 although in theory these formal procedures may provide the best way to ensure affected parties are afforded due process in the fda's rulemaking process, the reality is that these formal procedures are incredibly time consuming and inefficient. 76 consequently courts very rarely compel agencies to employ these formal measures, instead holding that the submission of written comments by interested parties satisfied the apa's requirements for a proper hearing.77 70 kenneth f. warren, administrative law in the political system 215 (2004). 71 rulemaking, black's law dictionary (9th ed. 2009). 72 warren, supra note 70, at 218. 73 id. 74 id. 75 id. at 219-20. 76 id. at 220 ("one hearing, which focused on whether peanut butter should contain 87.5 percent or 90 percent peanuts, produced a weighty 7,736-page transcript and lasted about nine years."). 77 id.; united states v. florida e. coast ry. co., 410 u.s. 224, 24041 (1973) ("[w~e are convinced that the term 'hearing' as used [in the apa] does not necessarily embrace either the right to present evidence 130 vol. 10:1 510(k) clearance the fdca included in its section 701(a) a general rulemaking grant for the fda to issue guidance, but this grant did not confer overarching legislative rulemaking authority.78 section 701 set forth detailed procedures for public hearings and judicial review to be followed in the promulgation of rules (formal rulemaking procedures), and section 701(a) granted a general rulemaking power to promulgate rules in the enforcement of the fdca.79 rules promulgated under the authority granted under section 701(a), however, were not granted the force of law because a violator of any regulations promulgated thereunder would not be subject to any sanctions, penalties, or other legal consequences.8 0 in contrast, there were several specific rulemaking grants throughout the fdca which authorized rulemaking with the force of law over specific issues; for example, misbranding and the use of marks, stamps, tags, or labels in foods.8 ' these regulations were given legislative effect by sections of the fdca which expressly made their violation unlawful and subject to penalties. 82 in the 1960s and 70s the fda began to assert a right to issue legislative rules using informal notice-and-comment procedures. 83 to do this, the fda's chief counsel peter barton hutt asserted that the fdca should be viewed as laying out a set of fundamental objectives for the agency and the broad authority to implement these objectives through a power to do anything not specifically made an exception or withheld by the fdca.84 orally and to cross-examine opposing witnesses, or the right to present oral argument to the agency's decisionmaker . . . . [tihe [apa] makes it plain that a specific statutory mandate that the proceedings take place on the record after hearing may be satisfied in some circumstances by evidentiary submission in written form only."). 78 thomas w. merrill & kathryn tongue watts, agency rules with the force of la w: the original convention, 116 harv. l. rev. 467, 557 (2002). 79 id. at 514. 80 id. at 515. 81 id. at 514 n. 244. 82 id. at 514. 83 id. at 558. 84 id. 2013 131 indiana health law review this theory eventually made it to the supreme court when regulations issued by the fda under 701(a) authority were challenged. 85 the court assumed without discussion that the fda indeed had the authority to issue the regulations.86 later, the second circuit in national nutritional foods association v. weinberger expressly held the fda has such general rulemaking authority. the court explained: congress' establishment of a specific (and elaborate) procedure in [i§ 701(e) authorizing the fda to promulgate regulations in certain fields was in addition to and not in derogation of the general rule-making power granted to the fda by § 701(a). under the latter section, furthermore, the fda may follow streamlined procedures designed to avoid the endless delays that have tended to paralyze adjudicatory hearings and render them ineffective as a means of utilizing agency expertise.87 although recognized by the courts as an efficient way for the fda to avoid the cumbersome hearings required of formal rulemaking in the exercise of its authority, informal rulemaking does present problems of its own for the fda. all branches of government have imposed additional procedural demands on the informal process, making it increasingly more difficult to issue rules in this way.8 8 in response, the fda has shifted toward the promulgation of nonbinding guidelines, which are quicker and easier to 85 see usv pharm. corp. v. weinberger, 412 u.s. 655 (1973); weinberger v. bentex pharm., inc., 412 u.s. 645 (1973); ciba corp. v. weinberger, 412 u.s. 640 (1973); weinberger v. hynson, westcott & dunning, inc., 412 u.s. 609 (1973). 86 merrill & watts, supra note 78, at 559. 87 nat'l nutritional foods ass'n v. weinberger, 512 f.2d 688, 69798 (2d cir. 1975). 88 lars noah, the little agency that could (act with indifference to constitutional and statutory strictures), 93 cornell l. rev. 901, 904 (2008). 132 vol. 10:1 510(k) clearance issue. one example of this is the fda's decision to, rather than amend its (at that time) twenty-five year old regulations defining and outlining "current" good manufacturing practices for drugs, instead issue guidance for the adoption of new and modern quality control technologies by the pharmaceutical industry.89 this growing dependence on nonbinding guidelines presents its own problems for the agency, however. not only can these rules escape the normal procedural safeguards set in place for rulemaking, but they also allow the fda to take a stance without establishing a definitive position, leaving the regulated entities guessing about their own obligations and rights under the guidance. 90 congress has recognized the importance of the ease and efficiency these guidance documents offer administrative agencies, and congress even endorsed a greater reliance on guidance documents issued by agencies.91 in the regulation of medical devices, the fda can issue rules or guidance pertaining to any aspects of the device that fall within the scope of the fdca which, due to the ability of medical devices to present a risk of injury, can be quite extensive depending on the device. for the purposes of the rest of this paper, "rule" refers to a regulation that has the force of law; one that subjects a violator to sanctions, penalties, or other legal consequences. 92 some examples of rulemaking include the general regulatory controls of safety and effectiveness93 such as regulations pertaining to gmp and labeling, postmarket surveillance, and adverse experience reporting (discussed in greater detail below).94 for certain higher-risk devices, regulations pertaining to 89 id. at 904-5; leila abboud & scott hensley, factory shift: new prescription for drug makers: update the plants; after years of neglect, industry focuses on manufacturing; fda acts as a catalyst; the three-story blender, wall st. j, sept. 3, 2003, at al. 90 noah, supra note 88, at 905. 91 id. 92 see generally merril & watts, supra note 78, at 515-16 (discussing legislative history granting rulemaking power to secretary of the fda). 93 21 u.s.c. § 360c(a)(1)(a)(ii)(ii) (2012). 94 general and special controls, supra note 17. 2013 133 indiana health law review specific aspects of the design or manufacture of the devices may also be available. there have been times when the fda has issued regulations for specific devices which impose particular labeling or warning requirements.95 an ex-ample of this is the fda's requirement 96 that tampons include labeling that warns customers of the dangers of toxic shock syndrome and how it can be avoided. 97 such requirements will not be uniformly applied to all classes of devices or all devices within a class, but may be imposed on specific devices or types of devices. in contrast, "guidance" refers to documents that are prepared for fda staff, applicants or sponsors of devices, and the general public that describe the fda's policy on or interpretation of a regulatory issue.98 guidance documents can relate to the "design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies." 99 guidance documents are helpful and persuasive, and can make the application and clearance process more efficient when followed, but do not have the same effect as regulations and do not amount to actual legal requirements. 2. reporting and postmarket surveillance due to the fact that devices brought to market through the 510(k) clearance process avoided any kind of premarket review, a strong postmarket surveillance system is 95 see 21 c.f.r. § 801.437 (2012) (providing labeling requirements for allergy warning on latex gloves); center for devices and radiological health, guidance for industry and food and drug administration staff: contact lens care products labeling (2010), available at http:// www.fda.gov/downloads/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm223665.pdf (providing guidance on labeling and package insert requirements for contact lens solution). 96 21 c.f.r. § 801.430 (2012). 97 nat'l bank of commerce v. kimberly-clark corp., 38 f.3d 988, 990 (8th cir. 1994). 98 21 c.f.r. § 10.115 (2012). 9s id. 134 vol. 10:1 510(k) clearance important to ensure the safety of medical devices. postmarket surveillance includes a variety of programs, including medical device reporting (mdr) by manufacturers and user facilities as well as third-party safety monitoring.100 reporting includes adverse-event reporting of incidents resulting in serious injury or death, and malfunction reporting after a device fails without causing an adverse event.' 0 ' most of this reporting is done by manufacturers, although the safe medical devices amendments of 1990 requires healthcare facilities to report device-related death or serious injuries to the manufacturer.102 generally, patients, healthcare professionals, and caregivers have no legal obligation to report adverse medical events; however, they can provide voluntary reports through the fda's medwatch program.103 there are barriers to the effectiveness of these programs, however. one of the fundamental steps of mdr is, after recognizing that an adverse event has occurred, linking that event with one or more possible devices as causal or contributing factors. 104 it can be difficult for practitioners to assess the role of the device in the patient's unique medical problem, since those with the relevant expertise may not be available to assist or take action at the time the patient presents for corrective action.105 for example, it may be easy for physicians to notice unexpected harms resulting from the use of a device, but they are less likely to detect an increased probability of familiar injuries that may result from the device.106 furthermore, be-cause the onset of 100 iom report, supra note 6, at 123. 101 id 102 id. at 124-25. 103 see id. at 124; safety. reporting by consumers, u.s. food and drug admin., http://www.fda.gov/safety/medwatchlhowtoreport/ ucm053074.htm (last visited nov. 26, 2012) (medwatch is the fda's voluntary reporting program for the reporting of serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors which result from the use of any human medical products, including medical devices.). 104 id. at 125. 105 id 106 catherine t. struve, the fda and the tort system: postmarketing surveillance, compensation, and the role of litigation, 2013 135 indiana health law review medical problems may be delayed, patients suffering the effects of problematic devices may no longer be patients of the facility which used the device in the patient's care, the facility with an obligation to report adverse events. 107 in contrast, the problems arising from the voluntary reporting through the medwatch program may result from over reporting. "the medwatch system generates some 22,000 reports each year, and of these a substantial number may not involve a causal link between the product and the injury." 0 8 follow-up inquiries and investigations performed by the manufacturers are important components of the postmarket surveillance process. the follow-up inquires, which are required by the fda for the majority of reports received, enable the manufacturer to fill in the gaps in the information initially reported 109 and en-able a better evaluation and assessment of the device and the event. investigations work to further improve the information in the mdr by filling in information gaps that may exist. however, investigations may be impeded by the patient, treating physician, or facility refusals to provide additional information.110 additionally, because physicians and healthcare facilities are not reimbursed for the time it takes to respond to requests for additional information, the efficacy of such follow-up may be impeded.11 ' once the manufacturer has obtained all the information about the event, it must then review the record in a timely fashion and determine whether the event meets the threshold for a reportable event.112 manufacturers have thirty days to report if a device may have caused or contributed to a death or serious injury, or if death or 2 yale j. health pol'y, l. & ethics 587, 603 (2005). for example, it may not be easy for healthcare professionals to determine whether a device may cause or increase the severity of a condition that is relatively common to the control population considered. id. at n.74. 107 iom report, supra note 6, at 126. 108 struve, supra note 106, at 604. 109 iom report, supra note 6, at 126. 110 id 111 id 112 id 136 vol. 10: 1 510(k) clearance serious injury could result if the malfunction reoccurs. 113 if the reportable event requires remedial action to prevent a substantial risk of harm to public health, the manufacturer must report within five days. 114 one study found that, in 2007, 31% of the critical five-day reports were submitted late and 39% of the death and injury adverse-event reports were late.115 "the inadequacy of the current postmarketing surveillance system and the resulting lack of data make it impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market.".116 each mdr is entered into an fda event database and screened by a safety analyst, "generally a nurse or engineer working for the fda," to identify a signal of risk for the potential harm.117 this task is not easily accomplished, due in part to the limited experience of the reviewer with the new device, a lack of input by the fda's premarket staff (who have gained some familiarity with the device as a result of the premarket notification process), and the large number of reports each individual analyst must address.118 efforts to reduce the workload of the safety analysts and to open communication between premarket staff and report screening staff have been thwarted by logistical problems arising from the fda's limited resources, the differing physical locations of the staff, and the heavy workload of all fda employees." 9 when signals are found, they are entered into the cdrh database, which includes information about medical device malfunctions as well as foreign inspections and labeling and software issues.120 the 113 id. at 127. 114 id. 115 id. 116 id. at 129. 117 id. at 127. 118 id. 119 id. at 127-28. 120 cdrh inspections database, fda.gov, http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproducts andtobaccolcdrh/cdrhtransparency/ucm223770.htm (last visited nov. 27, 2012). this database contains only information from inspections which were the cdrh's respon-sibility, about 25% of the total device inspections, and have been conducted since 2008. 2013 137 indiana health law review primary repository for adverse event reports remains the manufacturer and user facility device experience database, which is specific to medical device malfunctions and adverse events.121 however, this database is difficult to use because it does not incorporate relevant information from other fda databases, such as the cdrh database, and many of the entries are incomplete or misclassified.122 the different databases were created at different times to serve different purposes, and although they share information relevant to each other, the databases have not yet been incorporated into a single information source. in addition to reporting, the fda conducts postmarket surveillance of devices through a number of other mechanisms. the fda can issue orders requiring manufacturers to track certain types of devices through the distribution chain.123 this is done to ensure that manufacturers are able to promptly locate the devices in commercial distribution which, in the event serious health risks are presented by the devices, will facilitate notifications and recalls the fda may order.124 manufacturers are expected to have the ability to promptly provide information about the location of devices already distributed to patients and the devices in the manufacturer's or distributor's inventory.125 to improve the fda's tracking efforts, the fda amendments act called for the fda to develop a unique device identification (udi) 121 iom report, supra note 6, at 128; see also manufacturer and user facility device experience database (maude), fda.gov, http://www.fda.gov/medicaldevices/deviceregulationandguidancel postmarketrequirements/reportingadverseevents/ucml27891.htm (last visited nov. 27, 2012) ("maude data represents reports of adverse events involving medical devices. the data consists of voluntary reports since june 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since august 1996."). 122 iom report, supra note 6, at 128. 123 medical device tracking, fda.gov, http://www.fda.gov/medical devices/deviceregulationandguidance/postmarketrequirements/ medicaldevicetracking/default.htm (last visited nov. 27, 2012). 124 id. 125 iom report, supra note 6, at 129 (noting that information about distributed devices is expected be provided within ten days, and information about devices in inventory within three days). 138 vol. 10:1 510(k) clearance system. 126 although pilot activities have been conducted, this has not yet been implemented.127 manufacturers express concern about the alignment of the fda's udi standards with those of other regulatory systems and their ability to simultaneously comply with both.128 the fda has also established a postmarket risk identification and analysis system known as the sentinel initiative to enable the active monitoring of the safety of all fda regulated products.129 prior to this initiative, the fda had generally worked with healthcare systems individually to evaluate a particular product's safety issues, although it also made use of administrative and insurance claims databases in investigating safety of products.130 the sentinel initiative aims to create a linked, sustainable system that will draw upon the electronic healthcare data of many sources to enable continuous active monitoring of product safety.131 the initiative is still in its early phases of system planning and design, but a pilot "mini-sentinel" project has been developed.132 this project analyzed administrative claims data and de-identified electronic health record data with the hopes of uncovering information about medical device exposures and outcomes.133 while this 126 food and drug administration amendments act of 2007, p.l. 110-85, § 226, 121 stat. 823, 854 (codified as amended at 21 u.s.c. 360i (2007)). 127 iom report, supra note 6, at 133. 128 id. 129 fda's sentinel initiative background, fda.gov, http://www.fda.gov/safety/fdassentinel initiative/ucml49340.htm (last visited dec. 21, 2012) [hereinafter sentinel initiative]; see also food and drug administration amendments act of 2007, p.l. 110-85, § 905(a), 121 stat. 823, 944 (codified as amended at 21 u.s.c. § 355 (2007)) (noting that the sentinel initiative was to establish and maintain procedures for "risk identification and analysis ... of data on all serious adverse drug experiences"); but see iom report, supra note 6, at 131 (noting that the fda, through its general authority under fdca section 1003(b)(2)(c) has broadened the scope of the sentinel system to include medical devices). 130 sentinel initiative, supra notel29. 131 id. 132 iom report, supra note 6, at 131. 133 id.; see also background' history, mini-sentinel.org, http:// mini-sentinel.org/aboutus/ (last visited nov. 27, 2012). 2013 139 indiana health law review initiative will greatly facilitate the monitoring of fda regulated products, its ability to improve the monitoring of 510(k) cleared devices is limited. information about many issues, such as software problems, manufacturing defects, packaging and labeling errors, and errors resulting from device design, will not be gathered, leaving many potential safety consequences of 510(k) devices beyond the scope of the initiative's active monitoring. 134 the database created by the mini-sentinel program can be used to make assessments describing "exposures to medical products, occurrences of particular diagnoses and medical procedures, health outcomes among individuals exposed to medical products, [and the] impact of fda's regulatory actions and interventions."135 another pilot program, known as the medical product surveillance network (medsun), was implemented in an effort to improve the reporting of adverse events and near misses through the involvement of trained risk managers at various health facilities. 136 the hope is that the involvement of clinical professionals could improve not only the number of events reported, but also the quality of the information reported, 137 through the program's creation of a two-way communication pathway between the fda and the clinical site of care. 138 the information obtained could be analyzed to uncover how devices are used and how errors occur, to prevent injuries from reoccurring in future uses of the devices, while also identify-ing trends that hopefully could identify developing problems and enable them to be addressed earlier, to prevent injuries from occurring at all.139 134 iom report, supra note 6, at 132. 135 types of assessments, minisentinel.org, http://minisentinel. org/product-evaluations/ default.aspx (last visited nov. 27, 2012). 136 iom report, supra note 6, at 129. 137 id. 138 susan gardner & marilyn flack, designing a medical device surveillance network: report to congress (1999) [hereinafter medsun], available at http://www.fda.gov/medicaldevices/ deviceregulationandguidance/overviewmedicaldeviceprovisionsoffdamod ernizationact/ucml68938.htm. 139 id. at § 5.1. 140 vol. 10:1 510(k) clearance finally, section 522 of the fdca grants the fda the discretion to order any manufacturer to conduct post market surveillance on certain class ii or class iii devices.140 devices for which postmarket surveillance can be ordered include those whose failure is reasonably likely to have serious adverse health consequences, which are intended to be implanted in the body for more than one year or are life-sustaining or life-supporting devices used outside of a hospital facility, and devices which are expected to have significant use in pediatric populations.141 manufacturers required to conduct this section 522 surveillance shall, upon receipt of the order, have thirty days to submit a plain for the required surveillance, which the secretary of hhs must approve within sixty days.142 to be approved, the plan must effectively facilitate the collection of data useful in identifying previously unforeseen adverse events or other similarly helpful information.143 generally, these studies focus on "one or two aspects of performance" of the device. 144 the surveillance period may be ordered to last up to thirtysix months, and can be extended by mutual agreement between the manufacturer and the secretary.145 this time frame is too short to enable the discovery, through these studies, of latent safety or effectiveness problems that might arise in the use of the device.146 additionally, all critical information gleaned from the studies might not be required to be reported.147 140 federal food, drug and cosmetic act, 21 u.s.c. § 360i(a) (2012). 141 id. 142 federal food, drug and cosmetic act, 21 u.s.c. § 360i(b) (2012). 143 [d. 144 iom report, supra note 6, at 132. 145 federal food, drug and cosmetic act, 21 u.s.c. § 3601(b) (2012). 146 iom report, supra note 6, at 132. 147 id 2013 141 indiana health law review 3. enforcement powers a. administrative while there are many regulations in place governing medical devices, their ability to protect patients will depend upon the extent to which the regulations can be enforced. when there is a problem with the safety or efficacy of a device, the fda first seeks to work with the manufacturer to correct the problem voluntarily. in an effort to obtain voluntary compliance with a request the agency cannot directly impose on a manufacturer, the fda may threaten to withhold a benefit or impose a sanction in an effort to encourage compliance.148 if the manufacturer is unwilling, the fda has a number of legal remedies available to use in the enforcement of its regulations, including recalling the device, seizure of the device by federal marshals, or, for imported devices, detainment at the port of entry.149 when a regulation governing medical devices is violated, the first contact from the fda is often a warning letter to the responsible individual or entity, instructing the recipient to take prompt action to correct the violation.150 "warning letters are informal and advisory but are available to the public on the fda's website."151 the effect of such a letter varies depending on the type of approval sought for the device. however, devices seeking 510(k) clearance generally cannot be blocked by a warn-ing letter unless there is a "substantial likelihood" of a serious risk of health from the device because of a specific gmp violation. 152 in fiscal year 2011, the fda's center for devices and radiological health issued 175 warning letters.153 148 noah, supra note 88, at 906. 149 iom report, supra note 6, at 133. 150 id. at 134. 151 id 152 id. 153 warning letters by fda center fscal year 2011, fda.gov, http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781. pdf. vol. 10:1142 510(k) clearance the fda defines a recall as "the correction or removal of a device for human use where fda finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death."154 recalls are usually voluntary, and are undertaken by manufacturers and distributers in an effort to carry out their responsibilities to protect the public from a risk of injury from their product(s) as an alternative to an fda initiated seizure or other court action.155 recalls include not only a request for the return of the product, but also any measures taken to correct any unsafe features of the device, such as software patches, placing stickers on packaging, revisions of labeling (adding warnings or clarifying instructions), informational letters, and servicing in the field.156 additionally, manufacturers and importers are required to report to the fda any voluntary corrections or removals they take to reduce a health risk posed by a device. 15 7 the fda classifies recalls "according to the degree of hazard" posed by the device.158 the most serious recalls, class i, are reserved for situations where there is a "reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death."159 class ii recalls are the most common, and are used when a product may cause temporary adverse effects, but in which there is a remote possibility of irreversible consequences. 160 class iii recalls are used when the use of a product is not likely to cause adverse consequences, but for which there is enough likelihood to justify a recall.11 although recalls can be helpful in providing information regarding signs of device safety, as well as the point in a 154 21 c.f.r. § 810.2(j) (2012). 155 21 c.f.r. § 7.40 (2012). 156 iom report, supra note 6, at 134-35. 157 21 c.f.r. § 806.10 (2012). 158 iom report, supra note 6, at 135 (noting that degree of hazard determinations are "based on injuries or deaths that have occurred, the likelihood of occurrence, the population exposed, and the immediate and long-term consequences"). 159 21 cfr § 7.3(m)(1). 160 21 cfr § 7.3(m)(2). 161 21 cfr § 7.3(m)(3). 2013 143 indiana health law review product's life cycle at which safety problems may begin to arise, improved postmarket surveillance will still be required to provide the full story of the safety of devices in clinical use.162 for example, it is easy to assume that all devices which have not been recalled by the fda are safe and pose no potential safety problems; however, the possibility remains that some of these devices could have safety problems that have so far remained undetected. a study of 510(k) devices cleared between 1996 and 2009 revealed that 3,132 devices, or 6.47%, were recalled between 2003 and 2009, and of those devices, 26.1% were recalled multiple times.163 most of these recalls were due to errors in device manufacture or design, 28.8% and 28.4% respectively.164 among the devices cleared after 2003, the vast majority, 91.5% remained free of recalls six years after clearance.' 65 in 2011, the fda's center for devices and radiological health recalled 3,211 devices.166 the fda has many enforcement options available to it, and consequently many mechanisms by which to ensure compliance with its regulations, but it is the actual utilization of these powers that improves the safety of devices on the market. there has been a decline in fda enforcement actions, however. the issuance of warning letters declined by 50% between 2000 and 2005, reaching a fifteen year low.167 the fda center with the largest decrease was the center for devices and radiological health which, even in light of growing reports of device 162 iom report, supra note 6, at 135 163 william h. maisel, 510(k) premarket notification analysis of fda recall data, in public health effectiveness of the fda 510(k) clearance process: measuring postmarket performance and other select topics: workshop report 73 (theresa wizemann ed., 2011). 164 id. at 73-74. 165 id. at 73. 166 total recalled products by fda center fiscal year 2011, fda.gov, http://www.fda.gov/downloads/iceci/enforcementactions/ ucm285781.pdf. 167 u.s. house of reps. comm. on gov't reform minority staff special investigation div., prescription for harm: the decline in fda enforcement activity i (2006) [hereinafter decline in enforcement], available at http://oversight-archive.waxman. house.gov/documents/ 20060627101434-98349.pdf. vol. 10: 1144 510(k) clearance malfunctions during this period, issued 65% fewer warning letters in 2005 than 2000.168 this is an alarming statistic, particularly since reports have shown that the number of violations the fda has observed during field inspections has remained fairly constant over the years. 169 b. judicial if the administrative powers discussed above are not appropriate for a particular device, the fda also has the authority to exercise a number of judicial enforcement powers. section 304(g) of the fdca provides that the fda can detain devices for up to thirty days if it has reason to believe the devices are adulterated or misbranded. 170 the most common method for detaining products is seizure, which can occur anytime a suspected adulterated or misbranded device is in interstate commerce, held for sale, or any time after.171 the devices will be held until a condemnation decree is rendered by a court, at which point they may be destroyed as the court directs.172 although this may be an effective way to prevent consumers from suffering harm from adulterated or misbranded devices, this enforcement action will not offer much help in protecting the public from unsafe devices cleared through the 510(k) process, because these actions do not reach products that may be injurious due to their design.173 in fiscal year 2011, the fda's center for devices and radiological health seized only one device.174 the fda also has the authority to seek injunctions. 75 168 id. 169 id. 170 inspections, compliance, enforcement, and criminal investigations administrative detention of devices, fdagov, http://www.fda.gov/iceci/compliancemanuals/regulatoryprocedures manuallucml76980.htm (last visited dec. 21, 2012). 171 21 u.s.c. § 334(a)(1) (2012). 172 21 u.s.c. § 334(d) (2012). 173 21. u.s.c. § 334(a)(1) (2012). 174 seizures by fda center fiscal year 2011, fda.gov, http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781. pdf. 175 21 u.s.c. § 332(a) (2012). 2013 145 indiana health law review the fdca provides that courts shall have jurisdiction, when cause is shown, to restrain violations of the fdca.176 injunctions can be sought for any significant failure to comply with fda regulation, especially when the noncompliance has been identified as hazardous to health.177 this does not happen very frequently, however, and in fiscal year 2011, no injunctions were filed against any devices. 7 8 the timeliness of the evidence presented in support of the injunction is critically important; the currentness of the information makes the action credible and limitations on the need to update the evidence are important.179 courts will, in considering an injunction, evaluate the seriousness of the offense, the potential impact to the public, whether alternative corrective actions could be as effective as an injunction, and whether there is a likelihood of continued violation of fda regulations in the absence of an injunction.o8 0 injunctions are best suited for situations where a definite health hazard or strong consumer deception with regard to the device exists, when recall or seizure is impractical, or when the noncompliant practices are long-standing and previously uncorrected by other means. 181 seeking an injunction does not preclude any of the other enforcement mechanisms available to the fda. this enforcement mechanism will be helpful for 510(k) cleared devices rendered unsafe due to failures in gmp, labeling, or instruction, but it will not be helpful in removing devices found to be substantially equivalent to pre-1976 devices, because no regulations pertaining to 176 21 u.s.c. § 332(a) (2012); see also 21 u.s.c. § 331 (2012) (enumerating prohibited acts). 177 inspections, compliance, enforcement, and criminal investigations injunctions, fda.gov, http://www.fda.gov/icecii compliancemanuals/regulatoryproceduresmanuallucml76734.htm (last visited dec. 21, 2012) [hereinafter injunctions]. 178 injunctions by fda center iscal year 2011, fda.gov, http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781. pdf. 179 injunctions, supra note 178. 180 id 181 id 146 vol. 10:1 510(k) clearance product design have been imposed which can be violated. 182 finally, the fda is able to report violations to the department of justice (doj) for criminal prosecution. the fdca provides penalties for violations of the act, including one year's imprisonment andlor fines up to $1,000 for first time or unintentional violations, and three years imprisonment andlor a $10,000 fine for intentional or repeated violations. 183 before a punishment of this nature may be imposed, due process requires that any potential defendant have notice and an op-portunity to present their own facts. 184 "the office of criminal investigations (oci) is responsible for reviewing all fda matters for which a criminal investigation is recommended."1 8 5 if, upon review of the all of the available information, the oci decides that the request for a criminal investigation should be referred, it will be referred to the oci's office of the chief counsel, where documents will be prepared before being forwarded to the doj.186 c. when the regulatory process fails:' the tort system the primary reason for the enactment of the fdca and the mda and the creation of the fda was to protect consumers of medical drugs and devices. the fda does not act alone in protecting consumers, however. the tort system also seeks to protect consumers of medical products by providing compensation to those harmed by defective products, as well as providing incentives for manufacturers 182 compare medical devices: premarket approvals, u.s. food and drug admin., http://www.fda.gov/medicaldevices/productsandmedical procedures/deviceapprovalsandclearances/pmaapprovals/default.htm (last visited nov. 26, 2012) with fda, medical devices: premarket notification (510k), http://www.da.gov/medicaldevices/deviceregulationand guidance/howtomarketyourdevicepremarketsubmissions/premarketnotification 510k/default.htm 183 21 u.s.c. § 333(a) (2012). 184 21 u.s.c. § 335 (2012). 185 inspections, compliance, enforcement, and criminal investigations prosecution, fda.gov, http://www.fda.gov/iceci/ compliancemanuals/regulatoryproceduresmanuallucml76738.htm (last visited dec. 21, 2012). 186 id. 2013 147 indiana health law review to design safe products.1 87 the administrative and tort systems can work together to protect consumers; the fda can impose a risk/benefit analysis before the product can go to market, setting a floor for product safety, and the tort system can incentivize manufacturers to make products increasingly more safe as new information makes improvements in product design or labeling reasonable.188 the ability of the tort system to help regulate the safety of medical devices can be difficult, however. the mda contains an express preemption clause in § 360k, which provides that: [n1o state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement-(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.189 section 360k raises many challenges to even bringing a suit that alleges a device is unsafe in any way, causing injury to the patient. the collaborative view of the fda and the tort system has changed in recent years as pressure to increase innovation and bring more products to market has grown.190 some believe that fda regulation and review constitutes both a floor and a ceiling; that the tort system is counterproductive to ensuring consumer safety and that it deters manufacturers from developing much-needed new technologies due to a fear of tort liability.191 furthermore, critics have also argued that lay juries are incapable of 187 struve, supra note 106, at 587. 188 id. 189 21 u.s.c. § 360k (2012). 190 struve, supra note 106, at 587-88. 191 id. at 588. vol. 10: 1148 510(k) clearance understanding the scientific and statistical evidence that is relevant to determinations of a medical product's safety, and are consequently overly willing to help injured plaintiffs by overlooking the many other consumers who could benefit from the product. 192 these perspectives have affected the decisions rendered by courts regarding the preemptive effect of the mda's.preemption clause. the supremacy clause of the constitution gives congress the authority to pre-empt any state law that comes into conflict with the exercise of federal power. 193 first it must be determined whether congress explicitly intended to either preempt the state law claim, or leave the state law claim available. 194 such intention can be manifested in an express preemption or savings clause. 9 5 as noted above, the mda contains an express preemption provision, and therefore preempts state law. however, state law claims against product features that violate federal law will not be preempted because they are parallel to, and therefore not in conflict with, federal law. 196 the supreme court has decided one case regarding a device that reached the market through the 510(k) process, finding the state tort claims were not pre-empted. in medtronic, inc. v. lohr, the court held that the mda demands three things be present for preemption to apply: 1) a specific federal requirement 2) that applies to a specific medical device, and 3) which governs the safety and effectiveness of the device.197 therefore, the mda does not 192 id. 193 u.s. const. art. vi, § 1, cl. 2. 194 leflar & adler, supra note 16, at 710. 195 id.; cf victor e. schwartz & cary silverman, preemption of state common law by federal agency action: striking the appropriate balance that protects public safety, 84 tul. l. rev. 1203, 1205-06 (2010) (explaining that congress's intention to preempt state law may be implied through field preemption, which occurs when congress expresses an intention to occupy an entire regulatory field and thereby leaves no room for state regulation). 196 leflar & adler, supra note 16, at 714-15. 197 medtronic, inc. v. lohr, 518 u.s. 470, 500 (1996); see also donna b. devaney & patrick a. hamiltyon, the 10,000 pound gorilla: federal preemption in class iiimedical device cases, 80 ra b.j. 52, 54 (2006). 2013 149 indiana health law review preempt state common law defective design claims for devices which have gone to market through 510(k) premarket notification since allowing a monetary damages remedy does not impose additional "requirements" on the manufacturer, but rather provides the manufacturer with another reason to comply with the federal "requirements," namely, that the devices be reasonably safe and effective. 198 additionally, the court found the manufacturing and labeling claims, in this instance, were not preempted.199 since the state law labeling and manufacturing requirements apply to many different devices, they are laws of general applicability. 2 00 without specific federal requirements, there cannot be preemption of the state law claims because there is no conflict between federal and state requirements. 20 1 in light of the court's finding lohr, the tort system remains available to help regulate the safety of 510(k) devices by offering financial awards for injured plaintiffs as well as financial incentives for manufactures to pro-duce safe devices. this shift of the source of pressure on the medical device industry, from the fda to the tort system, to ensure the safety of medical devices makes sense in these circumstances, since the fda plays a much smaller role in the regulation of 510(k) cleared devices. this is very different from the impact the tort system has on devices 198 lohr, 518 u.s. at 495. 199 id. at 498. 200 id. 201 see generally 21 c.f.r. § 801.430 (2012) (stating that tampons must include labels describing the danger of toxic shock syndrome); nat'l bank of commerce v. kimberly-clark corp., 38 f.3d 988, 990 (8th cir. 1994) (holding the fda's requirement that tampons include labeling that warns customers of the dangers of toxic shock syndrome preempts state law); natural rubber-containing medical devices; user labeling, 62 fed. reg. 51021-01 (effective sept. 30, 1997) (to be codified at 21 c.f.r. § 801.437) (establishing the final rule of the fda allergy warning requirements for latex gloves); fed. drug. admin., ode doc. no. 1725, guidance for industry and food and drug administration staff contact lens care products labeling (aug. 15, 2010), available at http://www.fda.gov/downloads/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm223665.pdf (discussing labeling and package insert requirements for contact lens solutions). vol. 10:1150 510(k) clearance which have received pma. the supreme court held that mda preemption exists over claims that a device approved through the pma process violates state law. in riegel v. medtronic, inc., the court found that the pma process imposes "requirements" upon devices; requirements that are specific to each individual device granted approval. 202 consequently, the pma process is a federal safety review of the device.203 state law claims would therefore be preempted if they imposed either additional requirements, or requirements that came into conflict with those imposed by the fda. however, the court found that the mda's preemption provision does not prevent states from providing a damages remedy for parallel claims (claims premised on a violation of fda regulations) since such claims do not add to federal requirements. 204 many people, including both patients and doctors, were unhappy with the supreme court's decision in riegel granting broad preemption of state law design and warning claims, and feared it would have an adverse impact of the safety of medical devices. 205 on march 5, 2009, the medical device safety act of 2009 was introduced into congress. 206 this act would have added language to the mda that would restore a plaintiffs ability to bring state law claims for injuries caused by defective medical devices, 207 and have the effect of placing medical device claims on the same level as 202 riegel v. medtronic, inc., 552 u.s. 312, 322-23 (2008); see also medtronic, inc. v. lohr, 518 u.s. 470, 488-89 (1996) (interpreting the scope of the word requirement). 203 riegel, 552 u.s. at 323 (cf lohr, 518 u.s. at 488). 204 riegel, 552 u.s. at 330. 205 gregory d. curfman, stephen morrissey & jeffrey m. drazen, the medical device safety act of 2009, 360 new eng. j. med. 1550, 1550-51 (2009) (stating that "[ulntil [the riegel ruling,] the possibility of litigation for 'failure to warn' or design defect served as a strong inducement for device companies to be vigilant about the safety of their products"). 206 medical device safety act of 2009, h.r. 1346, 111th cong. (2009) [hereinafter medical device safety act], available at http://www. govtrack.us/congress/bill.xpd?bill=h1 11-1346. 207 id. 2013 151 indiana health law review pharmaceutical claims 208 with regard to preemption. 209 although this act received a lot of support, 210 by the end of the 111th session of congress it had not been passed and therefore was declared dead.211 it has not been reintroduced. 2 12 iii. proposals to fix the flaws in the system a. institute ofmedicine.: a new regulatory system for 510(k) devices in light of all of the issues already discussed surrounding the 510(k) process and the lack of pre-market evaluation of these devices for safety, proposals have been made to change the regulatory process and ensure device safety and effectiveness are evaluated on the front end, much as is the case for devices entering the market through the pma process. such changes will leave the fda alone to regulate devices, however, due to the preemptive effect these determinations would have on state tort claims raised by injured plaintiffs. to address many of the safety concerns surrounding the 510(k) clearance process, the fda asked the iom to review the process and determine whether the process adequately protects patients and, if not, what legislative, regulatory, or administrative changes would optimally achieve the goals of the 510(k) process. 213 the committee tasked with this evaluation is the committee on public health effectiveness of the fda 510(k) clearance 208 in wyeth v. levine, the supreme court reinforced the fda's position that state law offers an important level of consumer protection that complements the effectiveness of the federal laws governing pharmaceuticals. wyeth v. levine, 129 s. ct. 1187, 1202 (2009). 209 support the medical device safety act!, mdsa coalition (nov. 11, 2010), http://passmdsa.blogspot.com/2010/09/blog-post.html ("the bill will also reconcile the legal regime used for device manufacturers with the one used for drug manufacturers, in light of the supreme court's 2009 decision in wyeth v. levine."). 210 see id. 211 medical device safety act, supra note 206. 212 id. 213 iom report, supra note 6, at 4. 152 vol. 10:1 510(k) clearance process (cphe).214 the cphe made a number of recommendations in their report to improve the 510(k) clearance process and, consequently, improve the fda's regulation of these devices. the first conclusion drawn by the cphe was that the 510(k) process is not intended to evaluate the safety or efficacy of devices, and cannot be transformed into such an evaluation as long as the standard for clearance remains substantial equivalence. 215 in light of this finding, it recommended the design of a new regulatory framework enabling the 510(k) process to be replaced with a system that provides a reasonable assurance of safety and effectiveness throughout the device's life cycle. 216 the new system would involve both pre-market and post-market regulation, and would rely on scientific evidence in reaching determinations of safety and effectiveness. 2 17 although the greater reliance on scientific evidence and clinical data might be similar to the p1via process, the proposed framework would focus most efforts instead on post-market surveillance of these devices, and in that way maintain both efficiency in the approval process while also ensuring the safety of these devices throughout their life cycle. 218 although this may sound like an effective way to solve the issues raised by the 510(k) clearance process, once practical concerns are addressed it becomes apparent that this recommendation will require much more than congress passing new legislation to effectuate the desired changes. it cannot be forgotten that the fda is an already overburdened agency with limited resources available to it. as pointed out above, 510(k) pre-market notification has been helpful to both the fda and to the medical device industry because it offers a quicker way to bring devices to market which requires the filing of less information, and fewer hours of analysis, before clearance. although it may be desirable to increase the depth of analysis under-taken 214 id. at 16. 215 id. at 193. 216 id. at 196. 217 id. 218 id. at 197-99. 2013 153 indiana health law review by the fda before these devices go to market, because of the fda's limited resources, the likely effect will simply be a notable increase in the delay before the device actually comes to the market and becomes available to patients in need of these treatments. medical tourism already occurs due to the delay in the approval of devices for market in the u.s.219 this effect is further exacerbated by manu-facturers considering marketing their devices only abroad, forgoing the u.s. market and fda regulation entirely. 220 additionally, the "leniency" of medical device regu-lation in europe, and its consequential speed and efficiency, have not demonstrated a resulting harm to patient safety, as evidenced by the almost equal rates of device recalls in the u.s. and europe.221 therefore, additional pre-market study and analysis will not necessarily assure the safety and efficacy of devices. but adding additional barriers before a device first reaches the market will harm both the med-ical device industry and american patients by increasing the time before the device is available. 219 i. glenn cohen, protecting patients with passports: medical tourism and the patient-protective argument, 95 iowa l. rev. 1467, 1471 (2010). medical tourism describes the phenomenon by which patients of one country will choose to travel abroad to receive their medical care. there can be a number of reasons a patient would decide to engage in medical tourism. oftentimes, patients who are uninsured or underinsured may choose to travel to countries offering the required treatment at a much more affordable price. additionally, patients may be drawn to travel abroad because of the increased privacy the foreign locations offer. most important to medical device regulation, however, are the occurrences in which patients who cannot access needed treatments in their home countries will travel abroad to receive treatment in countries which have a quicker or less regulated medical device market and access devices there which are not approved for the american market. see generally andrew pollack, medical treatment, out of reach, n.y. times, feb. 10, 2011, at bi, http://www.nytimes. com/2011/02/10/business/lodevice.html?pagewanted=all (last visited dec. 27, 2012). 220 id. 221 scott davis et al., eu medical device approval safety assessment: a comparative analysis of medical device recalls 2005-2009 9 (2011), available at http://www.commerce.gov/ sites/default/ files/documents/201 1/july/report-european-us medical devicesafety_0. pdf. 154 vol. 10:1 510(k) clearance additionally, the cphe called upon the fda to improve the post-market performance surveillance of devices by improving its strategy for collecting, analyzing, and acting on device post-market performance information, and to make better use of its post-market regulatory authority. 22 2 recommendations were also made for the fda to implement a continuous quality-improvement program and develop procedures to evaluate the safety and effectiveness of software used by devices as well. 223 these measures will not alone be sufficient, however, to ensure the safety and efficacy of medical devices on the market today and in the future, as they raise new issues of their own. increasing the post-market surveillance efforts of the fda after the devices have reached the market will similarly raise its own problems. until the mdr databases can be improved, increasing reporting efforts and the depth of analysis of these reports will only be a daunting task for the fda. furthermore, until providers are better trained and more able to recognize effects caused by medical devices, efforts to increase reporting will not be effective. 224 the voluntary reporting of information will only be as helpful as the completeness of the information reported, and until the databases can be integrated, enabling all relevant information about a medical device to be made available at once and analyzed together, the conclusions that can be drawn from a device's post-market performance will be limited. the issues with the fda's post-market surveillance efforts are not unique to 510(k) cleared devices. in the past decade, the fda has seen an increase in the number of recalls of medical devices, as well as the number of adverse event reports, 225 which has prompted the analysis of the sufficiency of post-market surveillance efforts. in early 2003, cdrh conducted an internal evaluation of postapproval studies, studies done on devices after they are 222 iom report, supra note 6, at 10. 223 id. at 11-13. 224 see medsun, supra note 138. 225 daniel schultz, medical device safety fda's postmarket transformation initiative, 62 food & drug l.j. 593, 593 (2007). 2013 155 indiana health law review approved for marketing under the pma process, and found that this process overall did not perform as expected, and that this post-market surveillance tool and oversight both needed to be improved. 226 congress has also recognized the issues with post-market surveillance, and in 2002 directed 227 the secretary of hhs to study the effects of the medical device user fee program on post-market surveillance, and instruct the institute of medicine (iom) to study whether the post-market surveillance system of medical devices provides adequate safeguards regarding the use of devices in pediatric patients. 228 in the iom's resulting report, general shortfalls in the fda's entire postmarket surveillance process were recognized. 229 the iom identified "[t]he most obvious deficits in fda's performance are the agency's lack of effective procedures for monitoring the status of required post-market studies and the lack of public information regarding such studies."230 furthermore, the fda's authority to order post-market studies is limited. studies cannot be required as a condition of approving devices through the pma process, and for devices already granted pma approval; the fda cannot require postmarket studies that will last more than three years.231 b. use of comparative effectiveness research by the government as payer the limits which constrain the fda's regulatory 226 danica marinac-dabic et al., medical devices post-approval studies program: vision, strategies, challenges and opportunities, 62 food & drug l.j. 597, 598-99 (2007). 227 medical device user fee and modernization act of 2002, pub. l. no. 107-250 1071h cong. (2002), available at http://www.fda.gov/ regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/ significantamendmentstothefdcact/medicaldeviceuserfeeandmodernizati onactmdufmaof2002/default.htm. 228 marinac-dabic, supra note 226, at 598-99. 229 inst. of med., safe medical devices for children 5 (marilyn j. field & hugh tilson eds., 2005), available at http://books.nap.edul openbook.php?recordid=11313&page=rl. 230 id. at 6. 231 id. at 7. 156 vol. 10:1 510(k) clearance activities are caused primarily by the limited resources and funding available to the fda to carry out its activities. although the fda is certainly making an effort to work effectively even within these constraints, the effects are evident not merely in the outcomes achieved by the fda, but also in the performance goals it sets for itself. for example, in 2008 the fda set a performance goal to review 60% of original pma applications in 180 days and 90% in 295 days. 2 32 this goal was not met in 2008, but was exceeded in 2009. however, in recent years, the fda decreased its performance goal.2 33 the 2012 bud-get report predicted "[ilf the number of reviewers remains constant, cdrh expects performance levels to decrease due to the increasing complexity of pmas." 23 4 the goals for review of 510(k) applications have similarly been lowered in recent years, from 90% in ninety days and 98% in 150 days in 2010 to 75% in ninety days and 80% in 150 days for 2012.235 the fda explained, "[ilf the number of reviewers remains constant, cdrh expects performance levels to decrease."236 on the plus side, the fda's goals for the number of class ii and class iii device inspections, both domestic and foreign, have been increasing each year since 2008, and have been exceeded each year for which information is available.237 to improve the fda's ability to adequately exercise its authority and ensure the safety of the products it regulates, a budget increase would go a long way in alleviating the burdens the agency already experiences through its limited re-sources and manpower. consequently, the fda is 232 dep't health & human servs., food & drug administration: fy 2012 online performance appendix 42 (2012), available at http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/ reports/budgetreports/ucm242730.pdf. 233 id. at 42 (decreasing the performance goal to 50% in 180 days and 70% in 295 days in 2011, and 50% in 180 days and 60% in 295 days for 2012). 234 id. at 47. 235 id. at 42. 236 id. at 47. 237 id. at 44. in 2008, the goal of 1,270 inspections was exceeded with a total of 1,431 inspections that year. the goals have been increased to 1,365 in 2012 (exceeded with 1,659 inspections that year), and 1,515 for 2012. 2013 157 indiana health law review requesting a 17% increase in its budget as part of president obama's fiscal year 2013 budget.238 the majority of this increase would, under the proposal, come from industry user fees (such as application and inspection fees), which would account for 98% of this increase. 239 in previous years, about one third of the fda's budget was funded through user fees; under the new proposal, however, this amount would be increased to 45%.240 federal spending on the fda would be increased by only 0.5%.241 this new budget plan would bring the fda's total budget to $4.5 billion.242 however, the fda does not yet have cause to celebrate; obama's proposed budget plan must be approved by congress before it can be effective. debates over spending cuts, tax hikes, and resource allocation could easily stall this budget plan before the fda gets a chance to benefit from any of the proposed measures. 243 one important way the safety and efficacy of devices can be ensured without increasing the burdens on an already overwhelmed fda is through assigning to another agency or department the task of increasing the study and surveillance of medical devices. this can be done postmarket, and therefore would not infringe on the fda's authority, but instead would complement the fda's postmarket surveillance efforts. consumers and payers can also have an impact on the safety and efficacy of products available on the market. this can be done through the use of comparative effectiveness research (cer) in payer decisions to cover available devices, and can have the most 238 fda news release. fda seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply, fda.gov (feb 13, 2012), http://www.fda.gov/newsevents/ newsroom/pressannouncements/ucm291691.htm [hereinafter fda news release] (covering the period from oct. 1, 2012 through sept 30, 2013). 239 id 240 anna yukhananov, obama asks for hike in industry funding for fda, reuters, (feb. 13, 2012), http://www.reuters.com/article/2012/ 02/13/us-budget-fda-idustre81c24020120213. 241 id. total federal spending on the fda under this proposed budget would be $2.5 billion for fy 2013. 242 fda news release, supra note 238. 243 yukhananov, supra note 240. 158 vol. 10:1 510(k) clearance impact on the device market if the largest payer is able to make use of comparative effectiveness research in their coverage deter-minations: the government. the u.s. spends over $2 trillion on health annually.244 only about 5% of the u.s.'s overall health expenditures are devoted to research, and the vast majority of this goes to product development and basic research, not into assessing the effectiveness or outcomes of treatment options. 245 the first goal, therefore, should be to increase the amount of comparative effectiveness research being conducted. once helpful information has been gathered, it can be used by payers to incentivize the use of the most safe and effective devices available, thereby improving the care given to patients and helping to keep unsafe or ineffective devices cleared for the market without pre-market analysis or approval from being used in common medical practice until they are proven to be safe and effective, or at least as safe and effective as alternative treatments available. first, some background about cer may be helpful. studies focusing on the efficacy of a device, the extent to which the device will produce a beneficial result, are known as clinical effectiveness studies.246 these studies may consider the use of the device under ideal circumstances, or its use under ordinary circumstances (which usually involves a broadening of the delivery settings, patient populations, or avail-ability of alternative therapies in their analyses).247 results from multiple studies can be accumulated and assessed as a group, to enable conclusions of effectiveness to be drawn that will have sufficient weight to be reasonably used in practice. 248 the most effective use of the information obtained through these clinical effectiveness studies, however, is in 244 inst. of med., learning what works best: the nation's need for evidence on comparative effectiveness in health care 6 (2007), available at http://www.iom.edul-/media/files/activity% 20files/quality/vsrt/comparativeeffectivenesswhitepaperesf.pdf [hereinafter iomce]. 245 id. at 2. 246 id. at 7. 247 id. 248 id. 2013 159 indiana health law review comparing the effectiveness of alternative treatment options against each other to provide information about the relative outcomes of the interventions, and which will be most likely to produce the best patient outcome in different circumstances. 2 49 this is known as comparative effectiveness research, or cer. many experts recommend using the metric of "quality adjusted life-years" as the standard for measuring health outcomes.250 this metric would signify the effects of treatments in terms of gains or losses in time spent in any of a number of quality-weighted health statuses. in this way, the metric would enable a simple comparison of multiple treatment options over a range of patient conditions and diseases. 251 the utility and relative merits of different interventions (not limited to devices, but also diagnostic tests or surgical, pharmaceutical, or de-vice treatment options) can be obtained through the cer can be directly compared, enabling inferences to be drawn on the likelihood each has of achieving the best patient outcome possible.252 cer is not a new concept, and in fact research has been carried out in the u.s. for years, primarily under the auspices of the national institutes of health (nih), the agency for healthcare research and quality (ahrq), and the department of veterans affairs. 253 additionally, the fda, the centers for disease control, 254 and other hhs agencies have for years been contributing to cer.2 55 the basic information collected by the fda regarding the safety 249 id. at 7-8. 250 peter j. neuman & milton c. weinstein, legislating against use of cost-effectiveness information, 363 new eng. j. med. 1495, 1495 (2010). 251 id. 252 iom ce, supra note 244, at 8 253 john donnelly, health policy brief comparative effectiveness research, healthaffairs (oct. 8, 2010), http://www.healthaffairs.org/ healthpolicybriefs/brief.php?brief-id=27 (last visited dec. 27, 2012). 254 iom ce, supra note 244, at 9. the cdc funds research used in public health decision services and systems, some which examines the effectiveness of some infectious disease therapies or vaccines, and maintains a number of national data systems containing information important for certain types of clinical effectiveness studies. 255 id. 160 vol. 10:1 510(k) clearance and efficacy of products for which pma is required, as well as the information collected post-market through adverseevent reporting and other surveillance has been used in these efforts, and the sentinel network previously discussed will further help in this respect. 256 it is important to note that the fda does not require information of the comparative effectiveness of any product in order to grant approval; however, information specific to the product of its effectiveness for its indicated use is required for pma. 2 57 additionally ahrq, through a mandate contained in the medicare prescription drug, improvement, and modernization act,2 58 performs research focusing on patient outcomes, the appropriateness of treatments, and the comparative effective-ness of treatments. in carrying out this mandate, ahrq created the effective health care program that makes use of existing research to create comparative effectiveness reports, identify areas lacking in information about treatment effect-tiveness, and improve the delivery of the results found to providers and others.259 national interest in cer has risen over the years, a likely result of the increasing costs of healthcare. the american recovery and reinvestment act allocated $1.1 billion for conducting cer.2 60 additionally, the patient protection and affordable care act (aca) created the patient-centered outcomes research institute (pcori) to conduct comparative effectiveness research. 261 the use of cer in healthcare is not unique to the u.s. either, and in fact has been used by many other countries for years, both in coming up with clinical practice guidelines 256 id. 257 see premarket approval of medical devices, 21 c.f.r. § 814.20(b)(3)(v)-(vi) (2012). 258 medicare prescription drug, improvement, and modernization act of 2003, pub. l. 108-173 stat. 2066 (2003) (codified in 42 u.s.c. § 299(b)-(7) (2012)). 259 iom ce, supra note 244, at 9. 260 recovery act allocates $1.1 billion for comparative effectiveness research, hhs.gov, http://www.hhs.gov/recovery/ programs/os/cerbios.html (last visited dec. 2, 2012). 261 patient protection and affordable care act, pub. l. no. 111-148 § 1181(b), 124 stat. 119 (2010). 2013 161 indiana health law review as well as in making coverage determinations for government health plans. the uses of cer among these countries share some common traits, which the u.s. can learn from in making the best use of its own comparative effectiveness information. one important commonality among nations is the independence of the entities responsible for making comparative effectiveness recommendations have from the government. 262 although many are created andlor funded by the nation's government, the entities operate independently and include all stakeholders in the decision-making and methodology design processes. 263 additionally, most of these entities have been able to gain stakeholder support by including all stakeholders, especially manufacturers, in the design of the program and the decision-making process, 264 and making much of the information relied upon in making comparative effectiveness determinations available to the public.265 this will be important in not only ensuring the decisions reached will have con-sidered all sides of an issue, but also ensuring the affordability and completeness of information upon which decisions can be based, since the sector with the best capacity to generate and apply comparative effectiveness information is the manufacturing sector.266 establishing an appeals process by which comparative effectiveness decisions may be challenged by interested parties will also be important in gaining support from stakeholders and the public, as well as ensuring decisions are accurate based on 262 kalipso chalkidou & gerard anderson, comparative effectiveness research: international experiences and implications for the united states 3 (2009), available at http://www.academyhealth.org/files/publications/cerinternational_ experience_09%20(3).pdf. 263 id. at 3-4. 264 id. at 3. 265 see id. at 3. for example, the united kingdom's national institute for clinical excellence, makes all information upon which its decisions are based available to the public. all confidential information is carefully scrutinized by the institute, and it encourages the sources of such confidential information to make it available to the public as soon as possible. 266 iom ce, supra note 244, at 5. vol. 10:1162 510(k) clearance the data available at the time. 26 7 another important quality common among these countries is the modest budget and small number of people needed to operate the entities responsible for drawing conclusions from and making recommendations based on cer.268 most of these entities require only a few hundred employees to effectively carry out their duties, and have operating budgets of less than $60 million.269 to make these benefits possible, many of the entities rely on other bodies to conduct the research necessary to arrive at their conclusions, 270 much as ahrq and pcori are already able to make use of research conducted through other government entities and the private industry (made available through fda filings and reporting). this supports the prediction that charging another office or agency of the government with analyzing clinical effectiveness research of medical devices and arriving at comparative effectiveness determinations will be an affordable alternative way to ensure adequate post-market surveillance of 510(k) cleared devices, while also alleviating the burdens the fda already faces in carrying out its other duties. furthermore, this will provide additional incentives for the medical device industry to comply with federal regulations, which could potentially improve compliance even in light of the fda's budgetary constraints and the recent reduction in fda enforcement actions. 271 however, providers and patients alike expressed concern that the information gained from cer would be used to limit and deny coverage to patients who value the tradeoff between extending their life and the risk of disability differently than the government might. consequently, the aca, in an effort to alleviate these fears, expressly prohibited the use of cer findings to discourage anyone from choosing a particular treatment or therapy.272 267 chalkidou, supra note 262, at 4. 268 id. at 3. 269 id. 270 id. 271 see decline in enforcement, supra note 167, at i. 272 patient protection and affordable care act, pub. l. no. 111-148, § 1182(d), 42 u.s.c. § 1320(e)(1) (2010). 2013 163 indiana health law review specifically, the aca states: (d)(1) the secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title xviii in a manner that precludes, or with the intent to discourage, an individual from choosing a health care treatment based on how the individual values the tradeoff between extending the length of their life and the risk of disability. (2)(a) paragraph (1) shall not be construed to(i) limit the application of differential copayments under title xviii based on factors such as cost or type of service; or (ii) prevent the secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under such title based upon a comparison of the difference in the effectiveness of alternative health care treatments in extending an individual's life due to that individual's age, disability, or terminal illness. 273 the best way to ensure that patients receive the best possible care, and the most effective way to ensure the safety and effectiveness of devices cleared through the 510(k) process, however, is to enable the government to make use of comparative effectiveness information in their coverage decisions just as private insurers do, and consequently, the prohibition on the use of this information in coverage decisions should be lifted. concerns have been raised that the use of cer to 273 42 u.s.c. § 1320(e)(1). vol. 10:1164 510(k) clearance deny coverage will open the doors to the making of coverage decisions not on the patient's health outcome, but on the perceived value to society of the healthcare dollars spent, as measured by the patient's anticipated subsequent level of productivity in society.274 arguments supporting cer point out that true healthcare savings will result from changing how doctors think about healthcare, 275 and remembering that providing all available treatments is not necessarily in the patient's best interest nor will it necessarily lead to the best patient outcome. these arguments, however, have been met with opposition fueled by the fear that the result will be the denial of care to elderly or disabled patients, and patients will be discriminated against in the provision of 274 sarah palin, statement on the current healthcare debate, facebook (aug. 7, 2009), https://www.facebook.com/note.php? note_id=113851103434 ("the democrats promise that a government health care system will reduce the cost of health care, but as the economist thomas sowell has pointed out, government health care will not reduce the cost; it will simply refuse to pay the cost. and who will suffer the most when they ration care? the sick, the elderly, and the disabled, of course. the america i know and love is not one in which my parents or my baby with down syndrome will have to stand in front of obama's 'death panel' so his bureaucrats can decide, based on a subjective judgment of their 'level of productivity in society,' whether they are worthy of health care. such a system is downright evil."). 275 see, e.g., ezekiel j. emanuel & victor r. fuchs, the perfect storm of overutilization, 299 jama 2789, 2790-91 (2008) ("when evaluating a patient, students, interns, and residents are trained to identify and praised for and graded on enumerating all possible diagnoses and tests that would confirm or exclude them. the thought is that the more thorough the evaluation, the more intelligent the student or house officer. trainees who ignore the improbable 'zebra' diagnoses are not deemed insightful. in medical training, meticulousness, not effectiveness, is rewarded. this mentality carries over into practice. peer recognition goes to the most thorough and aggressive physicians. the prudent physician is not deemed particularly competent, but rather inadequate. this culture is further reinforced by a unique understanding of professional obligations, specifically, the hippocratic oath's admonition to 'use my power to help the sick to the best of my ability and judgment' as an imperative to do everything for the patient regardless of cost or effect on others. . . . rapid reforms of medical education and training, even when widely acknowledged as essential, are uncommon. . . . realistically, the most effective policy change would be to alter how insurance pays for medical services."). 2013 165 indiana health law review healthcare based on their age or health status.276 this is not at all the use of cer presented in this article, however. cer would be used not to deny all medical treatment for a patient, but rather to provide an incentive for healthcare providers to pursue the treatment options that will present the best possible clinical outcome for the patient. cer by definition involves the comparison of one treatment option to another in an effort to determine which of the two will achieve the best outcomes for patients with the studied illnesses or conditions. decisions to pursue a treatment option will be based not on the doctor's perception of the value to society that his particular patient presents, but instead on the potential that available options have to successfully treat the patient, based on sound clinical evidence. if a particular medical device is found through cer to be unable to give the patient a chance to achieve a better health outcome than another device, drug, or surgery may, then coverage of that treatment option would be denied under this article's proposal. the patient would still have the choice to pursue that treatment option if he wants to pay out of pocket for the costs (just as medical tourism presents this option to patients now),277 but the use of treatment options found through clinical evidence to be safer and to lead to better healthcare outcomes would be incentivized. in this way, the necessary post-market surveillance the fda does not have the resources to conduct will be undertaken by an agency of the government with the resources and manpower to effectively monitor the devices. additionally, concerns raised by the industry and patients that further regulation will dampen innovation and further delay the availability of devices in the u.s. market will 276 see, e.g., michele bachmann, the president's health care advisers, youtube (july 31, 2009), http://www.youtube.com/ watch?v=5chbvkgmevi (arguing that the health reform bill would result in the inclusion into a doctor's healthcare decision-making process considerations of whether the healthcare dollars "would be better spent on someone else," reserving medical care for only those patients who are non-disabled; who have not yet been irreversibly prevented from participating in society). 277 see cohen, supra note 219, at 1489. 166 vol. 10:1 510(k) clearance never be realized, because devices will still be cleared for marketing through the quicker process and remain available to patients278 even if government payers later determine, based on subsequently conducted cer, not to cover certain devices in certain circumstances. furthermore, the government will have enough leverage to effectively incentivize the medical device industry to improve the safety and efficacy of their devices. as already mentioned, overall the u.s. spends over $2 trillion on health annually, about 45% of these expenditures made by the government. 279 this figure includes all expenditures made under the medicaid and medicare programs, as well as expenditures made for the veterans health administration, indian health service, and federal employees health benefit plan.28 0 the government constitutes a large share of the payer market. medical device companies, understandably profit driven, will be much more inclined to put forth the effort to ensure their devices are safe and effective enough to qualify for coverage under government health programs than they would by coverage determinations of individual private insurers, which each cover a much smaller share of the patient market. limiting the devices covered under the government programs is not likely to result in harm to patient outcomes either. the u.s. spends more on healthcare than any other country, with per capita expenditures double that of european countries and at least 20% higher than every other country. 281 even with all of this spending on healthcare, the u.s. ranks are well below other countries in terms of health outcomes. the u.s. ranks twenty-eighth in the world for overall life expectancy at birth.282 specifically, the average life expectancy in the u.s. at birth in 2009 was 278 patients will still have the option to pay out of pocket for any treatments not covered by their insurer. 279 iom ce, supra note 244, at 6. 280 id. at 2. 281 id. at 3. 282 id. at 1. 2013 187 indiana health law review seventy-six years for men and 80.9 years for women. 283 by comparison, the life expectancies in the united kingdom were seventy-eight years and 82.2 years, 284 for france 77.8 and 84.8 years, 285 and for japan (with the world's longest life expectancy286) 79.6 and 86.5 years, 287 respectively. variations in healthcare service utilization are prevalent within the u.s. as well. it has been found that intensity of services for similar conditions can vary by as much as a factor of twenty, and achieve similar results. 288 even within the u.s. studies comparing the different healthcare spending rates between regions found that patients of the highest spending hospitals were 2-6% more likely to die than patients receiving care at the lowest spending hospitals.289 all of this evidence shows that higher spending and higher utilization of healthcare does not mean better health. quite the contrary, advances in medical technologies result in an increase in the treatments available to patients, and a widening of the eligibility criteria for already available procedures and treatments, 290 which can lead to greater utilization without a notable improvement in patient outcome.291 283 global health observatory data repository: united state of america, country statistics, world health organization (2011), http://apps.who.int/ghodata/?theme=country (last visited dec. 2, 2012). 284 global health observatory data repository: united kingdom, country statistics, world health organization (2011), http:// apps.who.int/ghodata/?theme=country (last visited dec. 2, 2012). 285 global health observatory data repository.* france, country statistics, world health organization (2011), http://apps.who. int/ghodata/?theme=country. 286 see howard steven friedman, 5 countries with the longest life expectancy: oecd, huffingtonpost.com (may 27, 2011) http:// www.huffingtonpost.com/howard-steven-friedman/lifeexpectancy-b_867361.html#s284378&title=5_sweden_814. 287 global health observatory data repository: japan, country statistics, world health organization (2011), http://apps.who. int/ghodata/?theme=country. 288 iom ce, supra note 244, at 1. 289 shannon brownlee, overtreated: why too much medicine is making us sicker and poorer 50 (2007). 290 ruud ter meulen, is rationing the inevitable consequence of medicaladvance., 27 med. & l. 71, 75 (2008). 291 brownlee, supra note 289, at 113. 168 vol. 10: 1 510(k) clearance even in light of all of these facts, it may be easy to wonder why devices should have a separate approval process at all. the fda regulates pharmaceutical drugs as well as medical devices; perhaps efficiencies could be created within the agency itself by using a single regulatory pathway by requiring all medical devices to go through the full pma process, like pharmaceuticals must. this would not be the answer, however, because there are significant differences between drugs and devices. for one thing, drugs have longer product life cycles than devices do. 292 this is because drugs are not likely to change over time, since changes in the molecular structure of the drug creates an entirely new drug that needs independent fda approval. in contrast, devices commonly experience incremental changes over time, and often the technology changes rapidly. 293 this constrains the possibility of conducting long-term premarket studies due to the likelihood the device will change, and consequently makes it difficult to study, or even detect, risks that emerge slowly from device use.2 94 furthermore, drugs may be used by potentially millions of consumers, while devices are used by a comparatively small number of patients. 295 the limited number of device users impedes the ability of researchers to conduct randomized controlled studies in an effort to detect rare adverse events or differences in effectiveness between products. 296 it is precisely because of these differences that devices must be regulated differently from pharmaceuticals, and why congress passed legislation crafting two different regulatory frameworks. 297 while accepting the need to regulate devices differently from pharmaceuticals, the argument can still be made that all devices should be required to undergo the more intensive pma process and the 510(k) clearance should be eliminated altogether, in the belief that this would ensure medical 292 iom report, supra note 6, at 17. 293 id. 294 id. 295 id. 296 id. 297 d. at 17-18. 2013 169 indiana health law review devices are safe before they ever reach the market. as already discussed, there has been debate about the proper balance the fda must strike between ensuring adequate evaluation of devices before being approved for market, and the need of patients to have timely access to new medical technologies as they are developed. although the sufficiency of the 510(k) clearance process has been questioned for years, it is obvious that the process enables medical device companies to get their devices to market more quickly than pma review. however, the more intensive pma process has been criticized by many in the medical device industry as hurting innovation and causing the u.s. medical device industry to lose its competitive edge overseas. 298 patients are harmed by these effects as well, since many medical device companies are now choosing to seek approval for new devices in europe first due to the speed with which the device can be approved for market. the difference can be quite significant; a heart valve able to be installed through a catheter, saving the patient from undergoing open-heart surgery, was approved in europe more than three years earlier than in the u.s.299 there are a number of differences between the review and approval processes for medical devices in the u.s. and europe. the european union's device regulation system is governed by three directives: the medical device directive, 300 the in-vitro diagnostic directive, 301 and the active implantable medical device directive. 302 each lays out guidelines for the approval of their respective devices, and contains a list of essential requirements that must be met by each product within its scope, requirements that can 298 pollack, supra note 219. 299 id. 300 eur. consult. ass., council directive 93/42/eec (june 14, 1993), available at http://www.emergogroup.com/files/europeconsolidated-mdd-93-42-eec.pdf. 301 eur. consult. ass., council directive 98/79/ed (oct. 27, 1998), available at http://www.emergogroup.com/files/in-vitro-diagnosticsdirective-98-79-ec-v2.pdf. 302 eur. consult. ass., council directive 90/385/eec (june 20, 1990), available at http://www.emergogroup.com/files/europeconsolidated-90-385-eec.pdf. 170 vol. 10:1 510(k) clearance be generally classified as either general requirements for safety and performance applicable to all devices, 303 or specific technical design and manufacturing requirements applicable to certain types of devices. 304 the approval system operates in a decentralized fashion, as countries coordinate their own approval system in accordance with the directives. each country's competent authority certifies for-profit "notified bodies," which are then authorized to approve a broad variety of goods for market, including medical devices.305 these bodies will accept and certify new device applications, and may request clinical data or other information, or may perform manufacturing quality assessments in making its determination. 3 06 currently, there are seventy-eight notified bodies, among thirty countries, authorized to grant certification and approve medical devices for marketing in the european union. 307 the medical device approval process in the european union is typically completed about twentyone months sooner than in the u.s.308 critics have countered with the argument that it is not that the fda's regulations are too stringent, but rather, the european union's regulation of medical devices is too 303 see eur. consult. ass., medical device directive, article 3 and annex 1 (june 14, 1993), available at http://www.emergogroup.com/ files/europe-consolidated-mdd-93-42-eec.pdf. 304 id. 305 davis, supra note 221, at 2. 306 id, 307 enterprise and industry: nando, bodies, european commission, http://ec.europa.eulenterprise/newapproach/nando/index. cfm?fuseaction=directive.notifiedbody&dirid=13&type-dir=no%2ocpd& pro id=99999&prc_id=99999&ann_id=99999&prcanx=99999 (last visited dec. 2, 2012). 308 todd v. dhavale, evaluation of the medical device approval lag between the united states and the european union 35 (2011), available at http://dspace.mit.edul handle/1721.1/68465. in a study of twenty years of approval data for 135 coronary stent, icd and spine class iii medical devices, it was found that the total average approval lag for these devices in the united states was over twenty-one months behind the european union. of the 135 devices studied, thirtyfour were approved in the european union but not yet approved in the united states. 2013 171 indiana health law review lenient.309 for example, "a breast implant, a lung sealant and an implant for elbow fractures were approved in europe but not in the u.s., and then had to be taken off the market in europe for safety reasons."310 although re-calls have in fact occurred, studies suggest the rates of recalls in europe and the u.s. are quite similar. one study found that the overall number of annual recalls of devices between 2005 and 2009 was very similar between the u.s. and europe, hovering around 21.311 the study found that for the u.s., 45% of the recalls related to pre-market issues while 55% related to post-market issues. 312 to compare, the rates for europe were 46% and 54%, respectively. 3 1 3 these findings suggest that the faster approval processes used in europe does not sacrifice patient safety. iv. conclusion it is apparent that the 510(k) clearance process does not sufficiently protect patients from unsafe medical devices. although creating a new regulatory framework involving more pre-market and post-market regulation and relying on scientific evidence in reaching determinations of safety and effectiveness is one possible way to improve device regulation, the feasibility of this method is limited due to the inability of the fda's current resource constraints. instead, the best way to ensure the safety and efficacy of medical devices is for the federal government, in its capacity as payer, to use cer of medical devices entering the market. this information would be used by these federal programs in determining whether or not devices will be covered, and will alleviate the burdens on the fda by shifting the responsibility for this increase post-market 309 pollack, supra note 219. other examples of devices approved in europe but not available in the united states include artificial disks for spines. 310 id. 311 davis, supra note 221, at 9. 312 id. at 7. 313 id. 172 vol. 10:1 2013 510(k) clearance 173 study and surveillance of 510(k) devices from the fda to other federal agencies. in this way, the u.s. will foster innovation and maintain a competitive market in the medical device industry, without sacrificing patient safety through this more efficient approval process. healthcare providers will likewise benefit from this proposal, as additional research is still conducted regarding the comparative effectiveness of new devices, and this information will be available to guide medical decision making and ensure patients receive the safest and most effective treatments available. pharmacovigilence and the plight of chronic pain patients: in pursuit of a realistic and responsible ethic of care pharmacovigilence and the plight of chronic pain patients: in pursuit of a realistic and responsible ethic of care daniel s. goldberg* and ben rich** i. introduction..................................... 84 ii. the convergence of two perfect storms .... ..... 86 iii. opioid contracts and the standard of care for chronic opioid therapy ............ .............. 88 iv. competing models of the physician-patient relationship .............................. ...... 90 v. a brief history of the use of physician-patient contracts ................................. ...... 93 vi. informed consent ......................... ...... 97 a. elements of informed consent as they relate to pain management........................... 98 b. important considerations in the process of informed consent for pain therapy.......... .......... 100 vii. opioid contracts in the management of chronic pain ............................. ............. 102 viii. the universal precautions approach.................. 104 ix. adherence monitoring through urine drug screening in opioid therapy .................... 108 x. chronic pain, stigma, and opioid contracts: a population-level bioethics analysis ...... ....... 109 xi. conclusion .............................. ...... 120 * daniel s. goldberg, assistant professor, the brody school of medicine, east carolina university; j.d., university of houston law center; ph.d., medical humanities, institute for medical humanities, university of texas medical branch. .. ben rich, professor and school of medicine alumni association endowed chair of bioethics, university of california, davis; j.d., washington university in saint louis school of law; m.a. & ph.d., university of colorado, boulder. indiana health law review i. introduction in this paper, we critique the increasingly prevalent approach in pain management that urges the universal adoption of medication adherence contracts (so-called "opioid contracts") and random urine drugs screening as tools for managing the risk involved in prescribing and consuming opioid analgesics. although the use of such opioid contracts and drug screening has received some recent attention in the bioethics literature, in this paper we advance new lines of criticism. we develop these criticisms in context of the use of opioid contracts through both dyadic and population-level perspectives, a combination of approaches that have rarely been deployed simultaneously in the bioethics literature on the undertreatment of pain. in the first portion of the paper, we criticize the turn to opioid contracts through analysis of the physician-patient relationship. we discuss several models of the relationship, and document the infirmities of a contractual model, which underpins the justification for opioid contracts. we move on to enumerate the essential elements of informed consent in context of the care of patients with chronic pain, and argue that properly understood, applied, and documented, scrupulous adherence to informed consent offers all of the benefits and none of the burdens of opioid contracts. we conclude the first segment of our paper by describing the "universal precautions" approach to opioid therapy that has been highly touted in recent years, and in the process identify our particular concerns with regard to it. the second portion of the paper balances the prior emphasis on the therapeutic dyad with a macrosocial approach leveraging techniques drawn primarily from population-level bioethics. the focus here is on the likelihood that widespread utilization of opioid contracts will intensify the stigmatization of chronic pain sufferers, an already highly-stigmatized group that is in turn disproportionately composed of other disadvantaged and stigmatized social groups. here, we define and operationalize disease stigma, explain why it is a pressing population-level bioethics issue on both descriptive and 84 vol. 11:1 pharmacovigilence normative grounds, and show how the use of opioid contracts as part of a universal precautions approach is much more likely to intensify than to ameliorate stigma, contrary to the claims of its proponents. we apply powers and faden's sufficientarian account of social justice as a way of grounding the normative claim that the intensification of stigma is ethically unacceptable because it is both independently associated with adverse health outcomes and because it constitutes a particularly pernicious form of social disadvantage that is disproportionately likely to impact already marginalized groups. before proceeding to the argument, it is important to note two caveats. first, we wish to emphasize our belief that one of the primary obstacles to ameliorating the devastating and inequitable undertreatment of pain in the united states is the conflation of this problem with the problem of safe and effective utilization of opioids. of course, both the undertreatment of pain and the safe and effective utilization of opioids are public health problems. however, there are profound clinical, empirical, and conceptual reasons to doubt that even the achievement of a reasonable opioid regulatory regime will substantially improve the undertreatment of pain in the united states. as we have documented these claims and the rationale for them elsewhere, we mention it here only to contextualize our present objectives, which are indeed focused on the use of opioids in the treatment of chronic noncancer pain.' notwithstanding our focus in this article, nothing argued herein should be taken as contrary to our belief that the undertreatment of pain and the safe and effective use of opioids are distinct public health problems, and that conflating them is a serious mistake. second, for purposes of this article, we wish to focus on a particular category of pain and a very specific aspect of treating it. our special concern and focus will be patients with moderate to severe 1 daniel s. goldberg, job and the stigmatization of chronic pain, 53 persp. biology med. 425 (2010); daniel s. goldberg, on the erroneous conflation of opiophobia and the undertreatment of pain, 10 am. j. bioethics, no. 11, 2010, at 20. 2014 85 indiana health law review chronic noncancer pain and whether the prevailing standard of care for prescribing opioid analgesics requires the use of a formal, written opioid contract that includes a provision for random urine drug screens, as a condition precedent for providing such therapy to any patient. we begin the substantive analysis by delving into some of the social and political context regarding the rise of opioid contracts and the undertreatment of pain. ii. the convergence of two perfect storms beginning in earnest in the early 1990s, governmental agencies and health professional organizations acknowledged increasing evidence of pervasive undertreatment of pain. one early response to this phenomenon was the convening of interdisciplinary panels of experts by the agency for health care policy and research and the promulgation of two extensive clinical practice guidelines. 2 eventually undertreated pain of all types came to be recognized as having reached epidemic proportions and a becoming a world-wide public health problem. 3 the normative dimension of tolerating the unnecessary affliction of so many prompted advocates to demand recognition of pain management as a fundamental human right.4 still more recently, the institute of medicine ("iom") report relieving pain in america characterizes 2 agency for health care policy and research, u.s. dep't of health and human servs., clinical practice guideline (no. 1): acute pain management: operative or medical procedures and trauma (1992); agency for health care policy and research, u.s. dep't of health and human servs., clinical practice guideline (no. 9): management of cancer pain (1994); world health organization [who], access to controlled medications programme, improving access to medications controlled under international drug conventions (feb. 2009), available athttp://www.who.int/medicines/ areas/quality-safety/acmpbrnotegenrlenfeb09.pdf. 3 see who, supra note 2. 4 see frank brennan et al., pain management: a fundamental human right, 105 anesthesia & analgesia 205, 211 (2007). 86 vol. 11:1 pharmacovigilence effective pain management as a "moral imperative" and a "professional responsibility."5 between the mid-1990s and the present, data strongly indicate that in the united states there has been an exponential increase in the retail sales of opioid analgesics, a main line form of treatment for moderate to severe pain.6 during roughly the same period deaths associated with the ingestion of opioids dramatically increased as well-142% increase between 1999 and 2004.7 there are also an increasing number of articles in the medical literature calling into serious question the safety and efficacy of opioids for the management of chronic pain over prolonged periods of time.8 however, there is a post hoc ergo propter hoc quality to some declarations that the pendulum has now swung too far away from the era of rampant opiophobia to the present when physicians allegedly are with reckless abandon prescribing opioids to anyone who complains of pain.9 such pronouncements fail to take account of the many potential sources, other than prescriptions written for pain patients, by which those who abuse or are addicted to drugs may obtain these medications. 10 moreover, data indicate that both in the united states and worldwide we are a very long way from winning the 5 inst. of medicine, relieving pain in america: a blueprint for transforming prevention, care, education, and research 3 (2011), available at http://books.nap.edu/openbook.php?recordid= 13172. 6 see dennis c. turk et al., treatment of chronic non-cancer pain, 377 lancet 2226, 2227 (2011). 7 see jane c. maxwell, the prescription drug epidemic in the united states: a perfect storm, 30 drug & alcohol rev. 264 (2011). 8 see paul f. white & henrik kehlet, improving pain management: are we jumping from the frying pan into the fire? 105 anesthesia & analgesia 10, 11 (2007). 9 see jane c. ballantyne & naomi s. shin, efficacy of opioids for chronic pain: a review of the evidence, 24 clinical j. pain 469, 469 (2008). 10 see human rights watch, global state of pain treatment: access to medicines and palliative care (2011), available at http://www.hrw.org/sites/default/files/reportshhr051 1w.pdf. 2014 87 indiana health law review still formally undeclared "war on pain."" at the same time, the long-standing "war on drugs" is shifting so as to accommodate a focus on the exponential increase in the abuse of prescription drugs. in a sincere effort by leaders in the pain medicine community to demonstrate an awareness of and appropriate concern for the recent epidemic of prescription drug abuse, the policy mantra has become one of balance, epitomized by the shared goals of insuring that pain patients receive the medications they require while at the same time minimizing the risk that such prescriptions will be abused or be diverted to others with no medical need for them. 12 one of our special concerns is that the mantra of balance has not been restricted to the policy realm of state and federal laws and regulatory policies. recently it has come to be viewed by some thought leaders as an essential component of "pharmacovigilence," or responsible opioid prescribing, and thereby required in order to practice consistent with the minimal standard of acceptable care. this move, we believe, presages a dramatic shift in the ethos of medicine and the fiduciary nature of the physicianpatient relationship. to these concerns we now turn. iii. opioid contracts and the standard of care for chronic opioid therapy in a recent commentary by three prominent pain medicine specialists, the authors noted that in 2010 an expert multidisciplinary panel commissioned by the department of defense ("dod") and the veterans health administration ("vha") had completed a two-year systematic review of existing medical literature in the field of pain management and concluded that "opioid treatment agreements are a standard of care when prescribing chronic 11 see david e. joranson & aaron m. gilson, a much-needed window on opioid diversion, 8 pain med. 128 (2007). 12 pain & policy studies grp., univ. of wis., achieving balance in state pain policy a progress report card (4th ed.) (2008). 88 vol. 11:1 pharmacovigilence opioid therapy."13 since the comprehensive clinical practice guideline implemented by the vha recommend that such agreements should be obtained from all vha patients prior to the initiation of opioid therapy, and that such agreements shall contain a provision whereby the patient consents to periodic unscheduled drug screens, we interpret the above quoted language as an assertion that the currently prevailing national standard of care requires a formal opioid contract and random urine drug screens for all patients undergoing opioid analgesia.14 we note, however, that the va/dod guideline does not preclude initiation of opioid therapy if a patient refuses to execute an opioid agreement. rather, it provides that "[platient refusal to sign an agreement should be documented in the medical record" and considered "part of the initial and ongoing assessments of the patient's ability to adhere to the treatment plan and level of risk for adverse outcomes."15 we shall presume that included in the vha/dod review of the medical literature were the federation of state medical boards model policy for the use of controlled substances for the treatment of pain, the expanded articulation of this model policy in a guidebook for clinicians under the title responsible opioid prescribing, and the american pain society/american academy of pain medicine clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain.16 however, none of these publications supports the position that the minimal 13 scott m. fishman et al., the opioid agreement: a real-world perspective, 10 am j. bioethics no. 11, 2010, at 14. 14 veterans admin. & dep't of def., clinical practice guideline for management of opioid therapy for chronic pain 3134 (2010), available at http://www.healthquality.va.gov/cot_312_fuller.pdf. 15 id. at 32-33. 16 see model policy for the use of controlled substances for the treatment of pain (2004) (fed'n of state med. bds.), available at http://www.fsmb.org/pdf/2004_grpolcontrolledsubstances.pdf', scott m. fishman, responsible opioid prescribing: a physician's guide (2009); roger chou et.al, clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain, 10 j. pain 113 (2009), available at http://download.journals.elsevierhealth.com/pdfs/journals/ 1526-5900/piis1526590008008316.pdf. 2014 89 indiana health law review standard of acceptable care for chronic opioid therapy requires a formal, written opioid agreement and random urine drug screens for all patients as a kind of "universal precaution." on the contrary, their consistent recommendation is that physicians should use their clinical knowledge, skills, and judgment in order to assess whether the patient presents an increased level of risk that would warrant the use of an opioid agreement. from this perspective, the insistence of some clinicians that opioid agreements and random urine drug screening should be a ''universal precaution" might reasonably be interpreted as an abdication of one's professional responsibility to make such an assessment and utilize it as a basis upon which to determine whether a formal written contract and random urine drug screening is warranted. further exploration of this possibility requires a brief discussion of the foundations for that responsibility. iv. competing models of the physician-patient relationship a detailed discussion of the extensive literature comparing, contrasting, and evaluating various models of the physician-patient relationship is beyond the scope of this article. however, a more focused consideration of two of these-the contractual and the covenantal-are particularly relevant to the legitimate role, if any, of formal written agreements between physician and patient in certain clinical situations. one particularly influential analysis offered by robert veatch sought to distinguish among four possible models: (1) the priestly (paternalism), (2) the engineering (physician as technician), (3) the collegial (physician and patient as fully equal parties), and (4) the contractual.1 7 according to veatch only the contract model could stand up to rigorous critical analysis at least in part because it appears to be consistent with the shared 17 robert m. veatch, models for ethical medicine in a revolutionary age: what physician-patient roles foster the most ethical relationship, 2 hastings center rep. 5 (1972). vol. 11:190 pharmacovigilence decision-making antidote to paternalism that respect for patient autonomy seemed to require. other prominent commentators seriously question the adequacy of a contractual model to exemplify not merely the fiduciary nature of the physician-patient relationship, in particular the physician's virtually unqualified professional responsibility to pursue the best interests of the patient and to recognize the patient's exquisite vulnerability in the face of illness.18 at least since the hippocratic era, those who enter the medical profession swear an oath to direct their professional energies toward the restoration and maintenance of the health of their patients above all else. the very nature of this oath conveys the strong sense of a covenantal relationship as the defining nature of the therapeutic dyad. the imbalance of knowledge and power is the central feature of any fiduciary relationship. this intrinsic imbalance is inconsistent with the contractual paradigm of an agreement between relatively equal parties mutually endorsing fully and freely negotiated terms. unequal parties do regularly enter into contracts, but the result is often regarded in law as a "contract of adhesion," a term of art denoting that the contract is a standard form drafted by and reflecting the interests of the stronger party which the weaker party must accept or reject "as is" with no opportunity for meaningful negotiation. 19 furthermore, in 1995 eight prominent physicians published a brief but cogent thought piece entitled "patientphysician covenant."20 the thrust of the piece is captured in the following passage: medicine is, at its center, a moral enterprise grounded in a covenant of trust. . . . physicians, therefore, are both intellectually 18 see, e.g., edmund d. pellegrino & david c. thomasma, a philosophical basis of medical practice (1981); wm. f. may, the physician's covenant: images of the healer in medical ethics (2d ed. 2000). 19 see, e.g., a.r. holder, what is a contract of adhesion? 13 irb: ethics & hum. subjects res. 10 (1991). 20 r. crawshaw et al., patient-physician covenant, 273 jama 1553 (1995). 2014 91 indiana health law review and morally obliged to act as advocates for the sick wherever their welfare is threatened and for their health at all times... . only by caring and advocating for the patient can the integrity of our profession be affirmed. thus we honor our covenant of trust with patients. 21 the responsibility of the physician to take on an advocacy role to ensure that the patient's needs for necessary or medically indicated treatment has been recognized by medical-legal commentators and medical organizations. 22 recognition of this professional responsibility reinforces the proposition that the pursuit of the patient's medical needs supersedes concerns about broader societal issues in the absence of any clear indication that the patient's conduct may imperil his/her own health as well as pose a threat to others. finally, in a recent special issue of the american journal of bioethics devoted to the issue of opioid contracts for chronic pain management, one commentator wrote of "the physician's covenant with the patient in pain."23 invoking may's conceptual analysis of the physician's covenantal relationship with the patient, the author argues: if physicians wish to remain true professionals, and not merely replaceable technician-cogs in the machinery of modern industrialized medicine, then physicians must strive to treat the patient as a covenantal partner rather than a consumer subject to a contract. . . . as a tool to help reinforce that relational expectation, a written memorandum from physician to patient, adjusted to the 21 id. 22 see, e.g., wi. sage, physicians as advocates, 35 hous. l. rev. 1529 (1999); accord american academy of pain medicine, ethics charter (2008), available at http://www.painmed.org/files/ethicscharter.pdf. 23 robert l. fine, the physician's covenant with patients in pain, 10 am. j. bioethics 23 (2010). vol. 11:192 pharmacovigilence patient's medical literacy, is certainly ethically appropriate and may be practically useful. however, having the patient sign the memorandum as a contract is neither.24 despite ongoing expression of concerns, there has been qualified support for adopting a contractual approach to at least certain aspects of patient care. it is important to consider the nature and limitations of that support before moving into a more targeted consideration of the ethical and legal dimensions and implications of opioid contracts. v. a brief history of the use of physician-patient contracts formal written contracts between physicians and patients, as documents separate and distinct from the usual and customary consent forms, are uncommon in most areas of clinical practice. proponents of the use of such contracts in certain patient care situations often cite an early article that makes the case for a contractual approach as promoting "partnerships in patient care."25 such a contractual approach, the author of that article maintains, is based on four assumptions: 1) both physician and patient have unique responsibilities in the relationship; 2) the relationship itself is voluntary and consensual, not obligatory; 3) both physician and patient must be willing to compromise in negotiating the terms of the contract; and 4) both parties must find benefit in the relationship that are reflected in the terms and conditions of the contract. 26 curiously, there is no discussion in the article about the doctrine of informed consent, the concept of shared decision making, or the relationship between those and a contractual model of the physician-patient relationship. there are several interesting aspects of the article that bear upon the specific phenomenon of opioid contracts. one is that the 24 id. 25 timothy e. quill, partnerships in patient care: a contractual approach, 98 annals internal med. 228 (1983). 26 id. 2014 93 indiana health law review typical opioid contract in use today is not the result of a negotiation between the physician and a particular patient, but rather a boilerplate form to which all patients must subscribe in order to receive opioid therapy, in other words, the quintessential contract of adhesion. second, among the clinical vignettes discussed by quill, the very first involves a patient undergoing long-term opioid therapy for chronic noncancer pain.27 one medical specialty that, even before the quill article, had embraced the use of contracts is psychiatry, at least for patients who were deemed to pose a risk of suicide.28 nevertheless, in a recent review of the practice, the authors critique the way in which such agreements are now used and note the paucity of any solid evidence that they are effective. 29 the agreement, consisting merely of a request that the patient affirm that she or he would not take her or his life, was originally conceived as an assessment tool. if a patient refused to make such a vow or sought to limit or qualify it, then they were deemed to be at increased risk of suicide. 30 in practice over the years, the concept of a nosuicide contract has morphed into an actual contract between patient and physician by which the patient commits not to engage in self-harm. one of the concerns expressed about this transformation is that the physician may rely excessively on the existence of the contract and fail to perform a careful assessment of the suicide risk, heavily exaggerating the patient's willingness or ability to report suicidal thoughts or impulses. 31 an alternative approach to suicide prevention in psychiatry has been advocated that calls for a greatly reduced emphasis on formal written contracts in favor of a 27 id. at 228. 28 see robert c drye et al., no-suicide decisions: patient monitoring of suicidal risk, 130 am. j. psychiatry 171 (1973). 29 keelin a. garvey et al., contracting for safety with patients: clinical practice and forensic implications, 37 j. am. acad. psychiatry & l. 363 (2009). 30 see drye et al., supra note 28. 31 see garvey et al., supra note 29. vol. 11:194 pharmacovigilence robust informed consent process. 32 many of the criticisms and concerns raised by these authors about the widespread practice of using suicide-prevention contracts are equally applicable to opioid contracts. for example, if the primary motivation for a contract is to meet a need or concern of the clinician, the result may be to undermine rather than promote establishment of a strong therapeutic alliance. the authors note, "patients are very sensitive to actions meant to protect clinicians but presented in the guise of being in the patient's interests."33 insistence on a contractual agreement can adversely affect the patient's motivation to engage meaningfully in the development of and adherence to a treatment plan. and just as critics of no-suicide contracts contend that they can reasonably be viewed as a form of defensive medical practice, the "risk management" motivation suggested by the proliferation of opioid contracts is not diminished by the abundance of rhetoric by their proponents that these instruments are truly in the best interests of all concerned. it is interesting to note the areas of clinical practice where one might have expected to find the use of contracts, particularly if the assertions of the proponents of opioid contracts were valid, but where in fact the medical literature suggests that they are not common. a relatively recent cochrane review considered "contracts between patients and healthcare practitioners for improving patients' adherence to treatment, prevention, and health promotion activities."34 this review assessed the quality of published data and the strength of evidence concerning the efficacy of such contracts. the aspects of patient care for which published data was available for consideration included the following: treatment of patients with addiction 32 see michael craig miller et al., talisman or taboo: the controversy of the suicide prevention contract, 6 harv. rev. psychiatry 78 (1998). 33 id. at 81. 34 xavier bosch-capblanch et al., contracts between patients and healthcare practitioners for improving patients' adherence to treatment, prevention and health promotion activities, cochrane database systematic revs. no. 2, 2007, art. no.: cd004808. doi: 10.1002/14651858.cd004808.pub.3. 2014 95 indiana health law review disorders, hypertension, obesity (weight control), as well as a small number of miscellaneous studies concerning patients with diabetes, arthritis, and tuberculosis. opioid therapy was not among those listed, nor was solid organ transplantation or chemotherapy for treatment of various malignancies. the absence of published data indicating that contracts are routinely used in other patient care situations where the risks of nonadherence are at least as significant as opioid analgesia tends to undermine the argument that opioid contracts are essential tools for protecting patients from the risks of deviating from the prescribing clinician's parameters. the reviewers concluded that many of the clinical trials were of poor quality, involved small numbers of participants, and provided insufficient evidence upon which to base a recommendation for the routine use of contracts as a means of improving patient adherence. 35 accordingly, much of the enthusiasm for opioid contracts has been completely detached from any solid evidence that they improve treatment efficacy.36 the reasoning of the proponents appears to be that the current absence of demonstrable evidence of the actual or potential harmful consequences of opioid contracts and random urine drug screens provides a sound basis upon which to conclude that they are beneficial. in this regard, the discussion noted above in the psychiatric literature about no-suicide contracts should provide at least some measure of concern that insistence and reliance upon contracts may in fact be both unnecessary and contraindicated. finally, lost in the rhetoric that zealously advocates for opioid contracts and random urine drug screens for all patients with chronic pain who are candidates for opioid therapy are the important cautionary points about the nature of nonadherence. one commentator describes as many as five types of nonadherence: undercompliance (nonuse and partial use), overcompliance, drug holiday, underuse followed by overuse before clinical visits (whitecoat phenomenon), and randomization (inconsistent use of s id. 36 see fishman et al., supra note 13. 96 vol. 11:1 pharmacovigilence medication).37 fishman and colleagues specifically note these varieties of noncompliance and the multiple reasons that may motivate or underlie both under and overutilization of prescription medications. addiction or abuse is only one of many different possible causes of the latter.38 they go on to point out, "a temptation exists to assume that patients with chronic nonmalignant pain who are not adherent to a treatment regimen are abusing medications. other causes of nonadherence . . . must be addressed in this population."39 they also note that "[ilmplementing and informing patients of ongoing adherence monitoring do not, in and of itself, assure good compliance . . . improving the ability of clinicians to discern nonadherence from ineffective therapy as the cause of drug failure will likely have substantial effect on treatment efficacy and safety."40 we now turn to the consideration of informed consent. the pain medicine literature discussing opioid contracts we will consider in subsequent sections of this article treats informed consent as an important element of opioid therapy, but not one obviates the need for opioid contracts. we argue that such thinking reflects an exceedingly narrow, rigid, and ultimately impoverished conceptualization of informed consent and its role in enhancing a shared understanding and purpose in pursuing a particular form of therapy. vi. informed consent the irrational exuberance many physicians have expressed for the indiscriminate use of opioid contracts strongly suggests a common belief that these documents provide a benefit which cannot be achieved through 37 joseph a. paladino, am. coll. of clinical pharmacy, is compliance with outpatient rx therapy common? (1991). 38 scott m fishman et al., adherence monitoring and drug surveillance in chronic opioid therapy, 20 j. pain & symptom mgmt. 293, 295 (2000). 39 id. at 304. 40 id. at 303. 2014 97 indiana health law review adherence to a thorough, ongoing, and well-documented informed consent process, and that this benefit outweighs any potential harm to the patient or the mutual trust and respect that is essential to the establishment and maintenance of a sound physician-patient relationship. we respectfully disagree and will make the case that informed consent as originally conceived would provide all of the purported benefits and reduce or eliminate many of the potential harms posed by opioid contracts. the duty to obtain an informed consent and to document the pertinent details of that consent in the medical record has been well-established in both american law and bioethics for decades for all but the most minimal and benign of medical interventions and therapies, and would certainly be required for treatment with opioid analgesics. 41 for purposes of this discussion, it should suffice to simply reiterate the essential elements of an informed consent and well-recognized principles for engaging in the informed consent dialogue, because in doing so it becomes clear why a written contract concerning opioid therapy is unnecessary unless the requisites of the informed consent doctrine have not been met. a. elements of informed consent as they relate to pain management a starting point is the diagnosis, along with an explanation of how and why the intervention will be likely to rule in or rule out one or more of the likely possibilities. in the case of opioid therapy, it is important for both the clinician and patient to understand that in contemporary medical thought chronic pain may well be a diagnosis rather than merely a symptom of some underlying disease or injury.42 the second element of informed consent is a discussion of the nature of the therapeutic intervention. 41 ben a. rich, a prescription for the pain:' the emerging standard of care for pain management, 26 wm. mitchell l. rev. 1 (2000). 42 nat'l ctr. for health statistics & ctrs. for medicare and medicaid servs., icd-9-cm (6th ed. 2009). 98 vol. 11:1 pharmacovigilence when this involves chronic opioid therapy, some basic discussion of the properties of the medication or medications to be prescribed should be provided, including how and why the medication(s) functions to relieve pain. a third element is the patient's prognosis with and without the recommended treatment. prognostication is considered much more uncertain than diagnosis because of the many other factors influencing how patient's react to and cope with illness, as well as their willingness and ability to adhere to a therapeutic regimen. this may be particularly true of chronic pain patients on opioid therapy, which makes candid exchanges and regular follow-up all that more important. a fourth element of consent-the anticipated benefits and risks of treatment-is perhaps the most critical one with regard to our contention that a properly conducted informed consent process is the optimal means of achieving the purported objectives of opioid contracts. this may be the most challenging part of the informed consent process for opioid analgesia because of the absence of solid clinical evidence for most of the recommendations found in current medical treatises and guidelines. 43 because of the level of concern about the percentage of patients on chronic opioid therapy who may have or develop a propensity for aberrant drug behaviors, the risks to be discussed with each patient must include both those intrinsic to opioid therapy, as well as the greatly increased risks to the patient if the medication(s) is not taken as directed. 44 in the discussion of the anticipated benefits of opioid therapy, the prescribing physician should make clear what she or he believes to be the realistic goal. there is now a strong consensus in the pain medicine community that simply achieving and maintaining a modicum of reduction in pain levels is not a goal of treatment worthy of assuming the risks of long-term opioid analgesia. it is essential, according to many thought 43 roger chou et al., supra note 16. 44 dennis c. turk et al., predicting opioid misuse by chronic pain patients: a systematic review and literature synthesis, 24 clinical j. pain 497, 506-07 (2008). 2014 99 indiana health law review leaders in the field, that the goals of treatment include improvement in the level of function.45 the recent emphasis in pain medicine that chronic opioid therapy cannot be deemed effective if only reduction in the levels of reported pain is achieved, but without demonstrable functional improvement, has a somewhat paternalistic if not authoritarian character. it relegates the assessment of benefit entirely to the prescribing physician. ultimately, it is the patient who must assume the risks and bear the burdens of any medical intervention, as well as endure the pain, suffering, and disability associated with the underlying condition. the victims of moderate to severe chronic pain are often desperate for some measure of deliverance from distress, and therefore may be willing to assume risks that someone who has never shared their experience, including clinicians, would consider to be excessive. while accurate medical information is essential to the risk/benefit calculation, ultimately it is a normative and subjective, not purely scientific and objective determination that each patient must reach, as with any other treatment decision. the final element of an informed consent involves consideration of the alternatives to the recommended treatment and the anticipated risks and benefits each would involve. of course, in all clinical situations, there is always at least one other option to the recommended treatment, i.e., doing nothing. this too involves risks, particularly if the recommended treatment is deemed medically necessary. b. important considerations in the process of informed consent for pain therapy informed consent, properly understood and practiced in clinical medicine, is an ongoing process, and in no situation is that true more than in the management of chronic pain. this notion is confirmed by the way in which opioid therapy as a treatment option has come to be characterized in the 45 see, e.g., amber huntzinger, guidelines for the use of opioid therapy in patients with chronic noncancer pain, 80 am. family physician 1315 (2009). 100 vol. 11:1 pharmacovigilence literature, i.e., as a "trial."46 an initial treatment plan and the goals it is formulated with the intent of pursuing is an essential feature of the consent process. consequently, that plan, and the efficacy of the specific measures undertaken to achieve its purposes, must be periodically evaluated based upon the patient's experience. this process is absolutely essential to shared decision making within the therapeutic dyad. one reason why some clinicians view consent as a discrete event, even outside the context of surgery, is an obsessive focus on the signing of the consent form. the form is simply a piece of documentary evidence. this is just one reason why the wholesale adoption of opioid contracts is problematic. as we will discuss more fully in a subsequent section, such contracts tend to take a certain form, consisting of a long list of "thou shalts" and "thou shalt nots" to which the patient is expected to unquestioningly agree in order to be provided opioid analgesia. there is no genuine meeting of the minds or any effort to tailor the agreement to a specific treatment plan in the formulation of which the patient has played any meaningful role.4 7 when a patient executes a written consent to opioid therapy she or he is explicitly agreeing to adhere to the treatment regimen, particularly taking the medications as directed. such directions will likely include not only the specific medication(s) and dosage, but also the proviso that no similar medications will be sought from other physicians. consent to the treatment plan will also include a commitment to regular follow-up appointments to reassess the efficacy of treatment and the presence of any complications from the prescribed medications. so understood, the detailed written consent covers all important aspects of sound opioid therapy and contains many of the uncontroversial provisions of an opioid contract, but does so in a way that does not single out chronic pain patients as do separate opioid contracts. 46 see chou et al., supra note 13, at 115-16. 47 robert m. arnold et al., opioid contracts in chronic nonmalignant pain management: objectives and uncertainties, 119 am. j. med. 292, 293-95 (2006). 2014 101 indiana health law review properly understood and appreciated, the informed consent process is not merely a boilerplate form that the patient must be persuaded to sign with a minimum of examination and explanation. we are not alone in our advocacy of it as a means of establishing and enriching the therapeutic dyad. particularly in areas fraught with uncertainty and challenge, of which opioid therapy for chronic pain is a prime example, it allows thoughtful and engaged physicians to acknowledge the profound level of uncertainty that pervades many aspects of patient care.48 there is, however, one aspect of the informed consent process that may require modification if it is to serve as superior alternative to an opioid contract. out of respect for individual autonomy, patients are allowed to decline to receive information about the nature of a proposed therapy and its benefits, risks, and alternatives. however, the emerging paradigm of responsible opioid prescribing essentially requires that the physician impart to the patient what is expected of her in order to safely embark upon a trial of opioid analgesia. thus, it may not be acceptable practice to allow patients to cultivate their ignorance of the conditions upon which a course of opioid therapy will be undertaken. with this perspective on informed consent and the recommended process by which it is used to facilitate shared decision making on a treatment plan, we now turn to the most common elements of opioid contracts in an effort to ascertain whether they offer anything to physician or patient that cannot be achieved through clear documentation of the process described above. vii. opioid contracts in the management of chronic pain discussion of opioid contracts for chronic pain patients undergoing opioid therapy is a relatively recent phenomenon. much of the early analysis of this phenomenon in pain medicine was done by fishman and 48 see, e.g., thomas g. gutheil et al., malpractice prevention through the sharing of uncertainty. informed consent and the therapeutic alliance, 311 new eng. j. med. 49 (1984). 102 vol. 11:1 pharmacovigilence colleagues ten to twelve years ago. even then, however, they reported that "contracts are widely used in the chronic administration of potentially abusable substances or management of lethal behaviors."49 fishman and colleagues found that by far the most common provisions in the thirty-nine contracts they reviewed dealt with the following: commitment by patient to avoid improper use of controlled substances (95%), specification of terms for disciplinary termination of the patient for violating the contract or engaging in other inappropriate behavior (92%), limitations on replacing medications or changing prescriptions (85%), providing physicians with relevant information (74%), and submission to random urine drug screens (69%).50 at the opposite end of the continuum, the least common provisions of these contracts were those that affirmed any joint responsibility of physician and patient for opioid therapy (5%), documented physician obligations under the contract (3%), or acknowledged the physician's obligation to provide treatment information to the patient (3%).51 fishman and colleagues further observed that "very few of the reviewed contracts suggest patients have any role in determining their terms.52 consequently, while these authors suggest that in some idealized sense the contract "is intended to enhance the therapeutic relationship by initiating and supporting an alliance between the patient and the physician,"53 it is very difficult to discern how the typical provisions they found in their survey would be conducive to that goal. rather, the most typical provisions strongly suggest an approach by which the prescribing physician lays down the law governing the patient's conduct and empowers the physician to terminate the relationship forthwith in the event of any violation by the patient. similarly, collen's survey of private practitioners revealed 49 scott m fishman et al., the opioid contract in the management of chronic pain, 18 j. pain & symptom mgmt. 27, 27-28 (1999). 50 id. at 30-31. 51 id. 52 id. at 32. 53 id. at 28. 2014 103 indiana health law review that the vast majority of contract provisions pertained to the consequences to the patient for violating any term of the agreement, rules regarding prescriptions and refills thereof, and submission to random urine drug screens. 54 it is plausible to suggest that for many patients, the insistence upon execution of a written contract with a long list of seemingly harsh and unilateral conditions by a physician will be a unique and disturbing experience. viii. the universal precautions approach ever-increasing utilization of opioid contracts and mandatory random urine drug screening had already become a prominent feature of pain medicine specialty clinics by 2005, when a seminal article advocating their use as a form of "universal precautions" in pain medicine was published.55 mimicking the wholesale adoption of a universal precautions approach to infectious diseases such as hiv and hepatitis, the authors recommend that certain minimal precautions be taken with regard to "all chronic pain patients regardless of pharmacologic status."5 6 underlying the application of the infectious disease model to chronic pain patients is the belief that identifying patients at risk of addiction or diversion is essentially as difficult as identifying patients with hiv or other serious infectious diseases and the consequences of a failure to do so equally perilous. in addition to our previously mentioned observation that the universal precautions approach, insisting as it does on opioid contracts and random urine drug screens for all patients on opioid analgesia regardless of the level of risk assessed, is inconsistent with current national guidelines and model policies, we wish to note further the disanalogy 54 mark collen, analysis of controlled substance agreements from private practice physicians, 23 j. pain & palliative care pharmacotherapy 357 (2009). 55 see douglas l. gourlay et al., universal precautions in pain medicine: a rational approach to the treatment of chronic pain, 6 pain med. 107 (2005). 56 id. at 109. 104 vol. 11:1 pharmacovigilence between the two. universal precautions in infectious disease are applied to all patients in all patient care settings. by contrast, not all patients receiving medications posing risks when not taken as directed are subjected to contract conditions and random urine drug screens; only those whose medically-indicated treatment includes an opioid analgesic are subject to those consequences. we will address in detail below the dubious claim that this application ameliorates the already prevalent stigmatization chronic pain sufferers who take opioids endure. for now, it is sufficient merely to note that this distinction undermines the analogy between the universal precautions approach as to infectious disease and that applied as to chronic pain sufferers for whom opioids are prescribed. the universal precautions approach in pain medicine includes a total of ten elements, only one of which do we believe is problematic, or two if opioid contracts and random urine drug screens are treated separately. the enumerated precautions are as follows: 1. diagnosis with appropriate differential; 2. psychological assessment including risk of addictive disorders; 3. informed consent; 4. treatment agreement (including a provision whereby the patient agrees to random urine drug screens); 5. pre-and post-intervention assessment; 6. appropriate trial of opioid therapy +/adjunctive medications; 7. reassessment of pain score and level of function; 8. periodic assessment of 4 a's of pain medicine: analgesia, activity, adverse effects, aberrant behavior; 9. periodic review of pain diagnosis and comorbid conditions including addictive disorders; and 10. documentation. prior to listing these ten commandments of responsible opioid prescribing the authors offer the sweeping assertions 2014 105 indiana health law review that "by applying the following recommendations, patient care is improved, stigma is reduced, and overall risk is contained."5 7 neither argument nor any reference to the literature is provided in support of any of these claimed benefits. similarly, in a more recent articulation of the universal precautions approach, gourlay and heit declare, "universal precautions as a concept is based on mutual trust and respect between patient and practitioner alike."58 there is an orwellian cast to the insistence that an effective means of demonstrating and promoting trust is for the empowered party in a relationship to demand that the disempowered party initially and continuously prove to the other by execution of a rigorous written contract and tangible evidence (urine drug screens) that they are upholding their pledge to access, utilize, and secure medications in strict accordance with doctor's orders.5 9 we have already presented argumentation in support of the position that properly understood and implemented, documentation of the informed consent process achieves whatever benefits are believed to flow from a written opioid contract. our objection to opioid agreements and random urine drug screens for all patients undergoing a trial of opioid therapy is based upon an understanding that assessing the presence or risk of addiction, as well as the potential for abuse or diversion of opioids is a reasonable and perfectly acceptable universal precaution. this approach is consistent with national guidelines and model policies and implicitly ascribes a minimal level of efficacy for currently available approaches to assessment of risk, to which we now turn. before doing so, however, it is important to emphasize how much more expansive and complicated is the universal precautions risk assessment for opioid s7 id. 58 douglas l. gourlay and howard a. heit, universal precautions revisited: managing the inherited pain patient, 10 pain med. s115, s116 (2009). 59 see lisa victor & steven h. richeimer, trustworthiness as a clinical variable: the problem of trust in the management of chronic, nonmahgnant pain, 5 pain med. 385 (2005). 106 vol. 11:1 pharmacovigilence analgesia is than for most other medical treatments. not only must the clinician arrive at a good faith medical judgment that the risks inherent in taking a particular opioid are outweighed by the reasonably anticipated benefits, but she or he is admonished to assess the risk that the patient might not strictly adhere to the treatment regimen or might not properly sequester the medication. although it has been extensively documented that nonadherence is a widespread problem in clinical practice, assessing the risk of that for each patient prior to initiating treatment is not generally viewed as part of the minimal standard of acceptable care. the only possible exception might be solid organ transplantation. because of the ongoing scarcity of viable organs for transplantation, it is important to identify and be prepared to support patients who are prime candidates for transplant but who present with factors suggesting that adherence may be challenging.60 nevertheless, insistence upon written contracts signed by patients pledging adherence and submitting to monitoring protocols do not feature prominently in the transplantation literature. it is beyond the scope of this article, and the competencies of the authors, to provide a detailed review and evaluation of the ever-increasing panoply of risk assessment tools upon which clinicians considering a trial of opioid therapy can draw. one overview lists nine of these.6 1 some are relatively simple and straightforward and therefore lend themselves to primary care settings, whereas others are more elaborate and time-consuming to utilize, and hence likely to be more suited to specialized pain medicine clinics and referral centers. for our purposes, the important point is that responsible risk assessment and stratification of patients can be undertaken by clinicians 60 see brigitta bunzel & kurt laederach-hofmann, solid organ transplantation: are there predictors for posttransplant noncompliance? a literature review, 70 transplantation 711, 715 (2000). 61 steven d. passik & pamela. sqyire, current risk assessment and management paradigms: snapshots in the life of the pain specialist, 10 pain med. s101, s104 (2009). 2014 107 indiana health law review consistent with current nationally promulgated clinical practice guidelines and model policies, supporting the reasonable exercise of clinical judgment as to whether a particular patient's situation warrants a heightened level of oversight and monitoring. the fact that such risk assessment is not foolproof is beside the point, since no physician is ever held to a standard of perfection. any suggestion that written opioid contracts and random urine drug testing insures such perfection cannot stand careful scrutiny, as the next section will demonstrate. ix. adherence monitoring through urine drug screening in opioid therapy an article by fishman and colleagues candidly reviews the challenges and limitations posed by various strategies to monitor adherence to opioid therapy. 62 first, their review acknowledges the critical point that we will develop below that contracts have the potential to perpetuate stigma. second, fishman and colleagues, consistent with the above noted critiques of no-harm contracts in psychiatry, warn that opioid contracts may create the illusion of adherence and result in a lower level of clinical scrutiny in the followup. third, on the matter of laboratory testing for opioids, these authors note that "[sluch tests are often compromised by variability and limitations in obtaining specimens, custody of specimens, laboratory methodologies, and interpretation of laboratory data."63 there is a risk of both false negative and false positive results. concentrations below the inherent limits of detection for a particular assay may result in a negative determination for a prescribed medication despite its actual presence in the patient. oxycodone, for example, may not test positive at even at a therapeutic dosage. false positive results may be caused by something as innocuous as the ingestion of poppy seeds. these authors also note that savvy clinicians should not jump to the conclusion that nonadherence with opioid therapy necessarily involves abuse. the broad range of 62 see fishman et al., supra note 49. 63 id. at 297. 108 vol. 11:1 pharmacovigilence patient behaviors regarding nonadherence is consistent with other studies indicating that failure to strictly adhere to prescription medication regimens is a widespread phenomenon cutting across many clinical conditions and prescription drugs.64 without careful inquiry into the type of nonadherence and the factors underlying it, clinicians may leap to erroneous conclusions that in turn lead to precipitous and unwarranted discontinuation of opioid therapy or in the most extreme cases discontinuation of the physician-patient relationship. we turn now to the final portion of our argument against the use of opioid contracts and universal drug screening, in which we address the risks of stigmatization that attend the widespread use of such tools. herein, we attempt to clarify some of the muddled thinking on the subject of stigma, which generally proceeds absent any informed theoretical understanding of the considerable literature on disease and health stigma, and we attempt to demonstrate the ethical harms that result from intensifying stigmatization of an already highly-stigmatized group (chronic pain sufferers). this final section balances the emphasis on the therapeutic dyad thus far with a macrosocial approach that focuses on the determinants of population health and relies on empirical evidence drawn primarily from social epidemiology. it is only through such a macro-level approach that the true health impact of stigma can be understood, and the ethical harms fully apprehended. x. chronic pain, stigma, and opioid contracts: a population-level bioethics analysis as we have chronicled the rise of opioid contracts as a tool for universal precautions, we wish now to focus on one of the primary justifications offered for their use: that of avoiding stigmatization. although this rationale is frequently cited, there is little literature that closely examines concerns of stigmatization as a justification for moving to the universal use of such contracts. this is 64see id. 2014 109 indiana health law review surprising at least in part because good evidence indicates that stigmatization is a common companion for many chronic pain sufferers 65 and that the risks and extent of such stigmatization are distributed disproportionately among various social strata (race, class, gender, age, etc.).66 although precise quantitative evidence on the prevalence of chronic pain stigma is lacking, the available evidence suggests its commonality, intensity, and inequitable distribution.6 7 disease stigma in general is an enormous clinical and ethical problem. because it can worsen disease outcomes, imposes a distinct form of psychosocial suffering, and is independently associated with increased morbidities and mortalities, such stigma is a major public health problem.68 moreover, as burris points out, narratives of 65 e.g., goldberg, job and the stigmatization of chronic pain, supra note 1, at 431; carole c. upshur et al., 'they don't want anything to do with you': patient views of primary care management of chronic pain, 11 pain med. 1791, 1794-95 (2010); jean e. jackson, stigma, liminality, and chronic-pain: mind-body borderlands, 32 am. ethnologist 332 (2005); anne werner & kristi malterud, it is hard work behaving as a credible patient: encounters between women with chronic pain and their doctors, 57 soc. scl. & med. 1409, 1414-15 (2003); joseph j. marbach et al., losing face: sources of stigma as perceived by chronic facial pain patients, 13 j. behav. med. 583 (1990). 66 see goldberg, job and the stigmatization of chronic pain, supra note 1; jackson, supra note 65; werner & malterud, supra note 65; dania palanker, note, enslaved by pain: how the us public health system adds to disparities in pain treatment for african americans, 15 georgetown j. on poverty l & pol'y 847 (2008). 67 see sources cited supra note 65;_see also palanker, supra note 66. 68 see, e.g., rebecca m. puhl & chelsea a. heuer, obesity stigma: important considerations for public health, 100 am. j. pub. health 1019, 1019-20 (2010); j. hong et al., the psychosocial and occupational impact of chronic skin disease, 21 dermatologic therapy 54, 57-58 (2008); peter a. vanable et al.. littlewood, impact of hiv-related stigma on health behaviors and psychological adjustment among hivpositive men and women, 10 aids behav. 473, 479-80 (2006); bruce g. link & jo c. phelan, stigma and its public health implications, 367 lancet 528, 528-29 (2006); d. vardy et al., experiences of stigmatization play a role in mediating the impact of disease severity on qualty of life in psoriasis patients, 147 british j. dermatology 736, 741-42 (2002). 110 vol. 11:1 pharmacovigilence disease stigma "would by and large melt a heart of stone, so that even if [disease stigma] had no adverse effects on health or public health practice, it may readily be seen as repugnant in a humane society."69 in addition, there is a well-developed literature on the significance of trust between the patient and the provider in both chronic disease management and chronic pain management in particular. 70 because the relationship between stigma and trust is profoundly inverse, it is essential to interrogate the presumed causal relationship between increased utilization of universal opioid contracts and decreased chronic pain stigma. we argue in this section that although the intention of ameliorating the absolute and inequitably distributed burdens of this stigma is laudable, the move to universal opioid contracts is both ill-advised and counterproductive, and it is much more likely to intensify chronic pain stigma than to ameliorate it. we further contend that this intensified stigmatization will disproportionately impact chronic pain sufferers in the most marginalized communities. we draw on powers and faden's account of social justice in health policy, which posits that actions that can be predicted to intensify the "densely-woven patterns of disadvantage" in which the most vulnerable and marginalized members of american society are situated are fundamentally unjust.7 1 because universal opioid contracts are likely to intensify stigma and erode trust, they run a dangerously high likelihood of exacerbating such densely-woven patterns of disadvantage. 69 scott burris, disease stigma in us public health law, 30 j.l. med. & ethics 179, 182 (2002). 70 see leonard e. egede & yvonne michel, medical mistrust, diabetes self-management, and glycemic control in an indigent population with type 2diabetes, 29 diabetes care 131 (2006); denise e. bonds et al., the association of patient trust and self-care among patients with diabetes mellitus, 5 bmc family practice 26 (2004); thomas a. laveist et al., attitudes about racism, medical mistrust, and satisfaction with care among african american and white cardiac patients, 57 med. care res. & rev. 146 (2000). 71 see madison powers & ruth faden, social justice: the moral foundations of public health and health policy passim, 71 (john harris et al. eds., 2006). 2014 111 indiana health law review given that there is a paucity of high-quality evidence showing significant benefits stemming from the use of universal opioid contracts, the very real harms that are likely to flow from their use renders their adoption ethically dubious. first, as we have noted above, we reject the peculiar notion that universal opioid contracts, by virtue of their utilization among all chronic pain sufferers for whom opioids are prescribed, ipso facto diminish chronic pain stigma. the generally accepted notion of disease stigma stems from goffman's seminal work 72 and, as interpreted by link and phelan, 73 consists of two central criteria: (1) a social group must mark another social group as different, by which process in-groups and out-groups are defined and branded, and (2) the in-group must assign a normative valence to the out-group; the out-group must be marked as deviant. because the marking of difference and the assignment of deviance require actors, it is inevitably people who stigmatize other people. moreover, the capacities to mark and to assign deviance are a function of the social, economic, and political power wielded by the in-group. 74 this links stigma to larger social inequalities, a point we shall return to shortly.75 as applied to universal opioid contracts, there is little rationale for the prima facie claim often asserted in the literature on universal opioid contracts that marking an already highly-stigmatized subgroup as an out-group in this additional sense would inherently be likely to ameliorate that stigma. moreover, the first portion of this definition of stigma shows the absurdity of the assertion that by virtue of their universality opioid contracts do not discriminate. such contracts unquestionably mark out a social group as different, the social group in question being chronic pain sufferers who utilize opioid analgesics. pain sufferers for whom opioids are either not indicated or are not 72 see erving goffman, stigma: notes on the management of a spoiled identity 126-160 (1963). 73 see link & phelan, supra note 68, at 528-29. 74 id. 7 id. 112 vol. 11:1 pharmacovigilence prescribed-a larger group than the frenzied attention expended on opioids and pain would suggest-are not subjected to such contracts. nor, to make the point more obviously, are adherence contracts utilized among patients for whom aspirin, beta blockers, or metformin is prescribed. note here that the "difference" criterion of stigma is in theory distinct from the "deviance" criterion. thus, the fact that chronic pain patients who take opioids are marked out as different does not necessarily show that the group is being stigmatized. however, it does repudiate the oftasserted and wholly unsupported idea that the utilization of universal opioid contracts somehow fails to discriminate, or mark out as different, a particular social group. it is essential to ask why it is that opioid-taking chronic pain sufferers are being marked as different. the answers given rest on the risks said to inhere in the prescription and use of opioid analgesics, the most significant of which are those of addiction and diversion. this implies that the use of opioids is "risky," and that the "riskiness" of prescribing and taking opioids is what merits the differential treatment. in turn, the presumed riskiness of chronic pain sufferers who take opioids highlights jean jackson's point that chronic pain is properly regarded as a liminal state in american society.76 in countless ways, chronic pain sufferers exist on the borderlands, and the classification of those who take opioids reflects this point-not quite drug abusers or addicts, but certainly of social concern in ways that those who take metformin or ranitidine are not. risk is of course a social phenomenon, which means it can spread along social networks; in this sense the riskiness of chronic pain patients that take opioids can flow to the physicians that prescribe those opioids, who undergo perceived risks in so doing and in turn become risky and liminal in and of themselves in the eyes of other social and institutional authorities such as state medical boards and law enforcement agencies. as jackson points out, this liminality matters for chronic pain sufferers in particular because those whom societies regard as liminal are at 76 see jackson, supra note 65; jean e. jackson, camp pain: talking with chronic pain patients 102-108 (2000). 2014 113 indiana health law review heightened risk of being marked as different and regarded as deviant.7 7 liminality in some contexts, chronic pain apparently being one of them, is a social marker for stigmatization. while the definition of stigma allows for a conceptual distinction between marking of difference and assignation of deviance, there is unfortunately ample reason to believe that the risk of slippage is extremely high. kurzban and leary argue for a functional-evolutionary explanation of stigmatization that explains "the important question of why an inherently social species with a strong need for social acceptance should be so inclined to reject members of its own kind."78 they posit that stigmatization fulfills several evolutionary roles centering on the need for humans to avoid some of the intensely negative experiences of social life. 79 hence, kurzban and leary contend that "human adaptations for sociality include cognitive mechanisms that cause people to be selective in their social interactions."8 0 they conclude that the commonality of stigma in social life can be explained at least in part by these adaptations.8 ' if there is merit to this theory, it suggests that a neat and easily-made distinction between difference and deviance is not reflective of the real costs of social life and that stigmatization is rather a common adaptive mechanism for coping with and managing those costs. in addition, the extremely common experiences of disease stigma in western history cast serious doubt on the extent to which the theoretical distinction between difference and deviance can be maintained in practice.82 thus even if we completely deny the evolutionary theory of stigmatization, disease stigma in the west is historically such a common occurrence as to belie the idea that an empowered group merely marking out a marginalized group 7 7 id. 78 r. kurzban & m.r. leary, evolutionary origins of stigmatization: the functions of social exclusion, 127 psychological bull. 187, 187 (2001). 7 id. 80 id. at 189. 81 id. 82 see goldberg, supra note 1. 114 vol. 11:1 pharmacovigilence as different on the basis of a recognized disease will generally be socially innocuous. history suggests the contrary. furthermore, even granting for the sake of argument that the historic and easy slippage between difference and deviance somehow does not occur with a group that already endures much stigma, the suspicion enshrined in universal opioid contracts may have a disparate impact on already marginalized and vulnerable groups. the term "disparate impact" is a legal term of art, with roots in antidiscrimination law. the necessity for prohibition of legal regimes and frameworks that had disparate impacts became apparent during the civil rights era in particular, taking shape in the seminal 1971 case of griggs v. duke power co. 83 in that case, duke power company ("duke") instituted an intradepartmental transfer policy in 1955 for its employees that required completion of a high school education. 84 immediately subsequent to the effective date of title vii of the civil rights act, duke added a second provision to the transfer policy, requiring putative transferees to "register satisfactory scores on two professionally prepared aptitude tests, as well as to have a high school education."85 these requirements applied to all employees, whether caucasian or african-american.8 6 thirteen african-americans filed suit under title vii, arguing that the practices were discriminatory even though they were facially neutral. the u.s. supreme court agreed, noting that under the requirements white employees fared far better than their black counterparts, traceable in large part to the legacy of inferior education offered to africanamericans in north carolina, where the action arose.87 the court reasoned that "absence of discriminatory intent does not redeem employment procedures or testing mechanisms that operate as 'built-in headwinds' for minority groups and 88 401 u.s. 424 (1971). 84 id. at 427. 85 id. at 427-28. 86 id. at 429. 87 id. at 430. 1152014 indiana health law review are unrelated to measuring job capability."88 moreover, the court noted, title vii is directed at "the consequences of employment practices, not simply the motivation." 89 we utilize the disparate impact analysis here solely by way of analogy; that is, we are agnostic on the question of whether the use of universal opioid contracts gives rise to an actionable civil rights claim. rather, we are focused on the ethical underpinnings of disparate impact analysis, which suggests that even policies that are universally applied can be intolerable if they have a disparate impact on an identifiable social group. applied here, closer scrutiny suggests ample reason to believe that universal opioid contracts may have just such a disparate impact on those most vulnerable members of the communities of chronic pain sufferers that take opioids. regarding these communities, there are stark inequities in the diagnosis and treatment of chronic pain, inequities which revolve around social strata like race, class, gender, and rurality, among many others.90 given the welldocumented fact that social disadvantages tend to cluster, those suffering from one form of social inequality are much more likely to experience the deleterious effects of other such inequalities.91 thus, someone who is of low socioeconomic status is significantly more likely to have low educational attainment, work at a job for low pay, difficult hours, and no job autonomy, and be exposed to various health risks such as environmental hazards, violence, and forms of discrimination (racism, sexism, ageism, etc.). as hilary graham puts it, "[ulnequal social positions carry with them unequal probabilities of being exposed to health 88 id. at 432. 89 id. at 433. 90 the literature on this topic is explosive. for an excellent discussion and a list of sources, see inst. of medicine, supra note 5, at 2-9 through -26. 91 see powers & faden, supra note 71, at 71, passim; jonathan wolff, disadvantage, risk and the social determinants of health, 2 pub. health ethics 214 (2009); daniel s. goldberg, global health care is not global health: populations, inequities, and law as a social determinant of health, in the globalization of health care 403 (i. glenn cohen ed., 2013). 116 vol. 11-1 pharmacovigilence hazards along the environment/risk factors/illness pathway."92 disease stigma is an example of one such health hazard inasmuch as it is independently correlated with poor health, 93 which implies that both the absolute burdens of disease stigma and the distribution of those burdens-which communities are at highest risk of being stigmatized-are critical questions in thinking about just and humane health policies. another such determinant of population health, one that is closely related to stigma and discrimination, is trust, which is frequently operationalized in the epidemiologic literature as a component of social capital. 94 although space limitations preclude detailed discussions of the social capital-health connection, there is little dispute in this literature that trust is a key variable in determining health and its distribution in populations. 95 the literature suggests that the significance of trust and social capital to health goes well beyond patient-provider relationships, but specifically impacts such relationships at least in part through the issue of medical mistrust.96 on this latter point, there is solid evidence that medical mistrust has a significant effect on outcomes of chronic disease 92 hilary graham, social determinants and their unequal distribution: clarifying policy understandings, 82 milbank q. 101, 113 (2004). 93 see supra notes 65-70 and accompanying text. 94 although the literature on this is immense, helpful starting points includethe following: simon szreter & michael woolcock, health by association? social capital, social theory, and the political economy of public health, in health and wealth: studies in history and policy 376-415 (2004); michael woolcock, the rise and routinization of social capital: 1988-2008, 13 ann. rev. pol. sci. 469 (2010); richard wilkinson & kate pickett, the spirit level: why greater equality makes societies stronger 51-62 (2009); ichiro kawachi et al., social capital and health: a decade of progress and beyond, in social capital and health 1-26 (ichiro kawachi et al. eds.); thomas abel, cultural capital and social inequality in health, 62 j. epidemiology & community health 1 (2008). 9 see szreter and woolcock, supra note 94. 96 see sources cited supra note 70. 2014 117 indiana health law review management.9 7 there is also good evidence that medical mistrust is an enormous problem among communities suffering from disproportionate rates of chronic illness,98 including pain.99 whether intended or not, the use of universal screening tools such as opioid contracts is likely to exacerbate this mistrust. the suspicion institutionalized in universal opioid contracts is therefore likely to have a disproportionate impact on those communities of pain sufferers that already suffer the most significant inequalities in (1) the diagnosis and treatment of pain; (2) social disadvantages that accumulate to produce more pain and worse health; (3) stigmatization and discrimination that are independently productive of poor health; and (4) medical mistrust that is inversely correlated with effective chronic disease management. the fact that all chronic pain sufferers that take opioids may be required to sign opioid contracts does not nullify the concern that such contracts will have a disproportionate impact on those most marginalized and vulnerable communities of pain sufferers. as the disparate impact doctrine shows, even policies that are universally applied can discriminate in unacceptable ways, and we believe that universal opioid contracts are a prime example of such a policy. the supreme court in griggs emphasized that the issue of disparate impact is not a function of the motivations of the privileged, but is rather focused on the consequences of the policies and practices at issue on the marginalized. 100 97 see laveist et al., supra note 70; accord wizdom powell hammond, psychosocial correlates of medical mistrust among african american men, 45 am. j. community psychology 87 (2010). 98 see laveist et al., supra note 70; b. ashleigh guadagnolo et al., medical mistrust and less satisfaction with health care among native americans presenting for cancer treatment, 20 j. health care poor & underserved 210 (2009); l. ebony boulware et al., race and trust in the health care system, 118 pub. health rep. 358 (2003). 99 joseph 0. merrill et al., mutual mistrust in the medical care of drug users: the keys to the 'narc' cabinet, 17 j. gen. internal med. 327 (2002). 100 griggs v. duke power co., 401 u.s. 424, 432 (1971). 118 vol. 11.1 pharmacovigilence the concern that universal opioid contracts may have a disparate impact on those communities of chronic pain sufferers already experiencing the effects of cumulative disadvantages and social inequalities implicates key issues of social justice. one of the most sophisticated and persuasive expositions of the concept is found in powers and faden's work, in no small part because they integrate into their theory much of the epidemiologic evidence regarding the social determinants of health and the clustering of social disadvantages. powers and faden utilize this evidence base as a means of discerning which inequalities are of paramount ethical significance for public health policy. they conclude: "which inequalities matter most? the answer we propose is that inequalities that contribute to systematic patterns of disadvantage are the ones that matter most."101 under this rubric, policies and practices that exacerbate the densely-woven patterns of disadvantage which characterizes life for those on the tail of the social gradient are unjust and should not be tolerated. because stigma and mistrust are themselves key variables in these densely-woven patterns of disadvantage, policies and practices that raise a significant risk of intensifying these experiences should at least be strongly disfavored, and to the extent their intensification of stigma and mistrust can be rigorously documented, can fairly be labeled unjust. powers and faden's formulation of social justice is critical insofar as it stretches the ethical scope of justice beyond the distribution of primary goods. thus, even where the use of universal opioid contracts does not preclude access to opioids for chronic pain sufferers that require them, their capacity for if not their likelihood of intensifying stigma and mistrust, and thereby worsening densely-woven patterns of disadvantage among alreadymarginalized communities, renders them ethically suspect. admittedly, the move to universal rather than ad hoc opioid contracts is rooted in an ostensible desire to ameliorate the stigmatization that so often accompanies the lived experiences of chronic pain. this goal is laudable, and 101 see powers and faden, supra note 71, at 193. 2014 119 indiana health law review our position here on the stigmatizing impact of universal opioid contracts is compatible with a belief that ad hoc opioid contracts pose significant concerns of selective application, discrimination, and stigmatization. our conclusion is that there are profound reasons to doubt that moving to universal opioid contracts substantially ameliorates these concerns. consequently, the appropriate policy question is not whether universal opioid contracts are preferable to ad hoc opioid contracts, but rather whether universal opioid contracts are truly preferable to no opioid contracts. disease stigma is pernicious. it is independently productive of poor health, can cause significant psychosocial suffering, and should not be tolerated in a just social order. practices and policies that threaten to institutionalize such stigma should be avoided wherever possible. moreover, there is incontrovertible evidence that millions of americans suffer persistent, sometimes intense pain for which safe and effective treatments exist, including but not limited to opioids. compounding this ethically intolerable situation, devastating inequities in the assessment and treatment of pain track virtually any social index that researchers have cared to examine. the conclusion that, as a society, the united states is and has been in the aggregate treating pain extremely poorly is unavoidable. we have grave doubts that it constitutes a humane response to this problem to institute policies and practices that pose a very real risk of stigmatizing the people whom we as a society are already failing. xi. conclusion in the summer of 2012, the finance committee of the u.s. senate announced that it was initiating an investigation of the financial connections between certain major pharmaceutical manufacturers of prescription pain medications and experts in pain medicine, organizations that issue professional guidelines for the prescribing of such 120 vol. 11:1 pharmacovigilence medications, and advocacy groups for patients with pain.102 the primary motivating factor for the investigation appears to be the prescription drug abuse epidemic alluded to in the introduction to this article and. more particularly, the suspicion that financial support of professional organizations in the field of pain medicine and their thought leaders has skewed practice guidelines, model policies, and even articles in peer-reviewed publications toward promotion of increased prescribing of opioid analgesics. the focus of the media accounts of this announcement was almost exclusively on those who acquire and misuse prescription pain medications and the injury and death that often follow from abuse of these medications. the plight of the many patients who receive and benefit significantly from these medications appeared as at best an afterthought and secondary consideration. for all of the reasons reviewed in this article, we now find ourselves in an increasingly hostile environment for chronic pain patients and the physicians who strive to treat them. more than ever, these patients are at risk that our society will revert to past prejudices against those who must rely on opioids for pain relief and functional improvement, and there is also a risk that our society will revert to a re-emergence of the opiophobia that plagued the health professions not so very long ago. the vulnerability of those afflicted with significant and persistent pain demands that medicine and society proceed with great caution in erecting barriers between conscientious physicians and their patients. finally, our criticisms of opioid contracts and the universal precautions approach ultimately do not depend on any substantive view of the propriety of opioid analgesics. that is to say, even if one maintains that the public health problem of prescription drug abuse sufficiently justifies curtailment of the use of opioid analgesics, it remains an open question whether the use of opioid contracts is 102 press release, u.s. senate comm. on fin., baucus, grassley seek answers about opioid manufacturers' ties to medical groups (may 8, 2012), available at http://www.finance.senate.gov/newsroom/ chairman/release/?id=02lc94cd-b93e-4e4e-bcf4-7f4b9fae0047 (last visited dec. 31, 2013). 2014 121 122 indiana health law review vol. 11:1 ethically justified as a means to that end. our position here is that regardless of one's perspective on the merits of the end, the universal use of opioid contracts is ethically dubious and should be scaled back if not abandoned entirely. using integrated care to meet the challenge of the ada's integration mandate: is managed long-term care the key to addressing access to services using integrated care to meet the challenge of the ada's integration mandate: is managed long-term care the key to addressing access to services? kimberly a. opsahl* i. introduction. .............................. ...... 212 ii background .............................. ...... 217 a. indiana's approach to developmental disabilities services .............................. ..... 217 b. olmstead's significance .................. ..... 220 1. olmstead's integration mandate.... .......... 220 2. omstead's impact for those 'at risk of institutionalization"............... ......... 223 3. effect on medicaid................... ....... 226 4. implications for indiana ............... ...... 227 iii. analysis .......................................... 228 a. medicaid managed care, special populations, and long term services and supports .............. 228 1. state example wisconsin's family care initiative 232 2. state example michigan ' combination 1915(b)/(c) medicaid prepaid specialty services and supports for persons with developmental disabilities ... ..... 235 3. state example pennsylvania ' adult comm unity autism program ....................... ..... 236 iv. lessons and implications for state approaches to dd services .............................. ...... 239 j.d. candidate, 2013, indiana university robert h. mckinney school of law; b.s., 1995, purdue university at indianapolis. effective january 1, 2013, ms. opsahl is the president/ceo for the indiana association of rehabilitation facilities. indiana health law review a. general recommendations .............. ...... 239 1. stakeh older engagement............ ........... 239 2. memorializing the program in statute .... ...... 240 3. quality measurement ................ ....... 241 b. indiana specific considerations.......... ...... 241 1. olmstead as a framework......................242 2. promoting access to services........... ...... 243 3. integrated funding..........................244 4. central point ofaccountability... ............ 245 v. conclusion ...................................... 246 i. introduction the indiana family and social services administration's division of disability and rehabilitative services ("ddrs") reports that over 8,000 indiana citizens with developmental disabilities are waiting to receive services through one of indiana's three home and community based service ("hcbs") waivers for individuals with developmental disabilities.' brenden was one of those waiting. diagnosed at birth with a developmental disability, brenden and his family received critical services through indiana's early intervention program that assisted him in achieving important developmental goals until he turned three years old. 2 at that time, brenden began receiving services through the local school corporation targeted at his academic achievement and was placed on the wait list for home and community based services. 3 now, twelve years old, brenden just began receiving the services that permit 1 family & soc. serv. admin., ind. div. of disability and rehab. servs.: quarterly update 2 (oct. 2012) [hereinafter ddrs: quarterly update], available at http://www.in. gov/fssa/files/ quarterlyreport-oct_2012.pdf (indicating that as a result of efforts to clean up the waiver wait list, the number of individuals waiting has decreased from over 19,000 names long in march 2012 to 8,486 as of october 1, 2012). 2 nquiet crisis.org: brenden, inquietcrisis.org, http://www. inquietcrisis.org/page.cfm?id=24 (last visited sept. 1, 2012). 3 id. vol. 10:1212 2013 integrated care and the ada integration mandate him the chance to develop the skills he needs to fully participate in his home and community nearly ten years after being placed on the wait list.4 george, on the other hand, continues to wait. he currently resides in a group home with other individuals with developmental disabilities.5 however, george's goal is to live in his own home in the community.6 working toward this goal, "george has learned to manage his medications, money, house work and take personal responsibility for himself."7further, by working two jobs, he has methodically saved the money he will need to move into his own apartment.8 despite his hard work, george is unable to further pursue his goal because the vital support he needs to live successfully in the community is unavailable to him.9 further, because he is currently receiving services through the group home, he is not considered a "priority" and can be passed over in favor others determined to be more in need of services. 10 4 id. 5 inquietcrisis.org: george, inquietcrisis.org, http://www. inquietcrisis.org/page.cfm?id=23 (last visited sept. 1, 2012) [hereinafter inquietcrisis.org, george]. 6 id. 7 id. 8 id. 9 id.; the arc of ind., an introduction to indiana's medicaid waiver program for home and community based services update 2-3 (2012), available at http://www.arcind.org/upload/assets/pdfs/ helpfulresources/introduction%20to%2oindiana's%20medicaid%20waive r%20programjune 2012_update.pdf (describing the purpose of medicaid waivers, as well as the use of wait lists which limit immediate access to waiver services). 10 inquietcrisis.org, george, supra note 5; see also advocates for disabled claim fssa is breaking law: supporters say agency isn't providing assistance for qualified hoosiers, wrtv 6 thelndychannel.com (oct. 5, 2011, 5:10 pm), [hereinafter advocates for disabled] http://www.theindychannel.com/news/29398905/ detail.html; family & soc. serv. admin., ind. div. of disability and rehab. servs.: community integration and habilitation waiver q&as from webinar 7-8 (2012), available at http://www.in.gov/fssal files/cihwaiverwebexqaddrs_ 06.29.12.pdf (there are two options available to individuals like george who wish to move into waiver services. the first option is to wait to access services until their 213 indiana health law review without access to community-based services, those on the wait list have limited choices. depending on their circumstances, they can try and manage without support, they can move into an institutional placement like a nursing home or large private intermediate care facility for the developmentally disabled ("icf/dd"), or if they already reside in an institutional placement, they can wait. in olmstead v. l.c, the united states supreme court recognized that "unjustified institutional isolation of persons with disabilities is a form of discrimination . . . ."11 citing to regulations implementing title ii of the americans with disabilities act ("ada"), the court found that "[a] public entity shall administer its services, programs, and activities in the most integrated setting appropriate to the needs of qualified individuals with disabilities."12 further, the court held that under title ii of the ada, states are required to provide community-based treatment for persons with mental disabilities when the state's treatment professionals determine that such placement is appropriate, the affected persons do not oppose such treatment, and the placement can be reasonably accommodated, taking into account the resources available to the state and the needs of others with mental dis-abilities.13 since that historic decision, courts have extended olmsteadbeyond those who are institutionalized in order to name "comes up" on the wait list for the family support waiver, which is capped at $16,250 and may not afford sufficient funding for the amount of support the individual needs. the second option is to wait until the person experiences an "emergency" which triggers the needbased criteria now in place to access the community integration and habilitation waiver, which provides comprehensive services based on individual need.). 11 olmstead v. l.c. ex rel. zimring, 527 u.s. 581, 600 (1999) (plurality opinion). 12 id. at 592 (quoting 28 c.f.r. § 35.130(d) (1998)). 13 id. at 607. 214 vol. 10:1 2013 integrated care and the ada integration mandate reach individuals like brenden and george. 14 often states argue that economic limitations, not an intent to discriminate, lie at the heart of their struggle to meet the need of soaring waiting lists and therefore olmstead's integration mandate should not be applicable.' 5 however, this argument that economic limitations prevent states from complying with the mandate is rarely successful as evidenced by the many wait list related olmstead challenges ending in settlement agreements. 16 these settlement agreements memorialize the state's commitment to meaningfully address if not eliminate the waiting list for services."7 indiana has made great strides in rebalancing services toward integrated, community-based options for those individuals with intellectual and developmental disabilities that are already in the service delivery system. 18 over nearly a decade of planning and effort, the state, with some encouragement from the united states department of justice ("doj"), moved hundreds of individuals from large, 14 see generally gary a. smith, status report: litigation concerning home and community services for persons with developmental disabilities 4 (2007), available at http://www. hsri.org/news-events/status-report-litigation-concerning-homeandcommunity-services-for-people-/. 15 id. at 4 (discussing instances where courts rejected state arguments based on economic limitation). 16 id. (indicating that sixteen of twenty-five wait list related lawsuits ended in a settlement agreement, as of may 2007). 17 id. at 4-5 (describing the typical terms of wait list settlement agreements). 18 david braddock & richard hemp, establishing a tradition of commitment: intellectual and developmental disabilities services in indiana 2 3 (2008), available at http://www.in. gov/gpcpd/files/braddockreport.final_10_10.pdf ("from 1977 to 1988, the i/dd institutional population in indiana declined by an average two percent per year, half the national rate of decline. however, during 1999-2008 the ijdd institutional census decline rate in indiana accelerated to 18% per year."); see also robin cooper, mssw with dennis harkins, going home keys to systems success in supporting the return of people to their communities from state facilities 9 (2006), available at http://www.nc-ddc.org/ publications/goinghomeoctober_06.doc. 215 indiana health law review congregate institutional settings into their own homes and communities with services funded through the medicaid hcbs waiver, fulfilling olmstead's primary charge. 19 however, individuals like brenden, george and the other 8,000 plus indiana citizens with disabilities struggle each day to remain in their home and community choice. for those on the outside waiting to get into the service delivery system, there is more work to be done. with a failing economy and mounting pressures to provide more services with fewer resources, indiana's service delivery system is at a tipping point. 20 using olmstead as a framework, indiana can leverage the current challenges into an opportunity to transform the service delivery system. this can be accomplished by using medicaid managed long-term services and supports as a tool to more effect-tively manage and predict cost, facilitate 1o braddock, supra note 18, at 6. 20 advocates for disabled, supra note 10 (discussing concerns with the availability and cost of services); see also maureen hayden, families of autism face long wait yme: legislator says state services system is 'broken'and 'dysfunctional' kokomo tribune, oct. 26, 2011, http://kokomotribune.com/local/x1990853208/families-ofautism-face-long-wait-time ("commission member and state sen. jean breaux, an indianapolis democrat, said those numbers show a system 'so broken and so dysfunctional' that the state needs to look at dismantling the current system and creating a more effective way to make sure families with the most pressing needs are getting help."); charles wilson, ind. group for disabled pushes improved services, businessweek (nov. 1, 2011), http://www.businessweek.com/ap/ financialnews/d9qo370g1.htm (last visited sept. 5, 2012) ("'we've got to change some of the basic premises that we're dealing with here,' john dickerson, executive di-rector of the arc, told a conference in carmel. 'we can't just keep cutting back. if we do, we're turning our back on people and it just won't serve anyone well."'); indiana state workers suggest leaving disabled people at homeless shelters, foxnews.com (oct. 28, 2010), http://www.foxnews. com/us/2010/10/28/indiana-stateworkers-suggest-leaving-disabled-people-homeless-shelters/ (last visited sept. 5, 2012) ("indiana's budget crunch has become so severe that some state workers have suggested disabled people at homeless shelters if they can't be cared for at home, parents and advocates said."); h.e.a. 1001, 117th gen. assemb., 1st reg. sess., chap. 45 § 4(a) (ind. 2011), available at http://www.in.gov/legislative/bills/2011/pdf/he/he1001.1. pdf (directing the development of a plan to reduce the per person and aggregate waiver spend). 216 vol. 10:1 2013 integrated care and the ada integration mandate community integration, and meaningfully address the wait list. in order to adequately explore the possibilities and implications of this assertion, part ii of this note explores indiana's historical and current approach to services for individuals with developmental disability services, and examines omstead's significance on issues related to access to services, the doj's current stance, and its impact on medicaid. part iii of this note discusses the evolution of using medicaid managed care in the delivery of long-term services and supports including state examples applying managed care to services for individuals with developmental disabilities. finally, part iv evaluates what elements of these medicaid managed long-term services and supports approaches are critical for meaningfully impacting access to services, as well as making the case for how this type of approach could support indiana in more effectively responding to the needs of its citizens with developmental disabilities. ii. background a. indiana's approach to developmental disabilities services historically, indiana relied heavily on state operated, institutionally based services for individuals with intellectual and developmental disabilities. initial efforts to reduce the state's reliance on these services began in the late 1970s through early 1990s with the development of small, community-based icfs/dd, also known as group homes. 21 in 1992, indiana began offering home and community-based waiver services as an alternative option for persons with developmental disabilities. 22 coinciding 21 the univ. of minn. research and training ctr. on cmty. living and the lewin grp., a review of the medicaid home and community-based services program in indiana: final report 9-10 (2001), available athttp://rtc.umn.eduldocs/indiana.pdf. 22 ind. family and soc. servs. admin.: div. of disability and rehab. servs., policy options to support individualized and 217 indiana health law review with the advent of this new option, the state began a long struggle with scathing, high-profile reports of wide spread client abuse and neglect at state-operated facilities, which ultimately resulted in doj involvement. 23 in 2007, the daily average census of persons with developmental disabilities in indiana's state operated facilities was 147 persons, and indiana was one of nine states, including the district of columbia, without a dedicated institution for individuals with developmental disabilities.24 this shift to community-based services was also precipitated by the historic "317 plan,"25 which resulted in a series of recommendations aimed at improving communitybased services, including addressing the then 6,000 individuals waiting for services. 26 the study was the result of "a bipartisan task force of consumers, advocates, and state officials that was charged [through senate enrolled act 3171 with conducting a study of services for people with developmental disabilities." 27 as a result of both the legislature's efforts to rebalance funding toward community-based settings and the state's commitments to the doj to fundamentally address deficiencies in its institutional settings, 28 indiana's hcbs waiver revenue has exceeded icfs/dd revenue since 2004 two years ahead of projections and clear evidence of its commitment to community-based, integrated services. 29 despite this progress, indiana still has significant challenges related to ensuring the availability of appropriate community-based services. specifically, indiana has the fourth highest rate of nursing home utilization for person centered services and funding 17 (mar. 28, 2001), http://www.in.gov/fssa/ddrs/2864.htm. 23 see generally tim swarens, state of misery: muscatatuck state developmental center's residents have long faced abuse and neglect, indianapolis star, mar. 5, 2000, http://www.dimenet.com/dpolicy/ archive.php?mode=n&id=205; cooper, supra note 18, at 9. 24 braddock, supra note 18, at 5. 25 id. at 6; see also cooper, supra note 18, at 9. 26 braddock, supra note 18, at 11. 27 id. at 11-12. 28 id. at 6; see also cooper, supra note 18, at 9. 29 braddock, supra note 18, at 24. 218 vol. 10:1 2013 integrated care and the ada integration mandate individuals with developmental disabilities. 3 0 in addition, despite serving over 13,000 people in the hcbs waiver for individuals with developmental disabilities, the wait list for those services exceeded 8,000 for 2011.31 since 2007, approximately 1,040 new individuals are brought into services each year.32 yet, individuals still wait for approximately nine to twelve years before they are able to access services. 33 the gravity of this issue has prompted legislators to declare that indiana's system is "broken" and "dysfunctional" and should be reconceived to "create[] a more effective way to make sure families with the most pressing needs are getting help."34 these challenges are compounded by recent activities within indiana's general assembly. specifically, the general assembly directed ddrs to develop a plan to reduce both the aggregate and per person spending in indiana's waiver programs. 3 5 this directive identified six potential approaches for achieving this outcome including "evaluating whether a group home [operated under the icf/dd program] or a waiver home is the most appropriate use of resources" and "evaluating alternative placements for high cost individuals to ensure individuals are served in the most integrated setting appropriate to the individual's needs and within the resources available to the state."36 these directives have the potential to significantly change the manner in which services are planned, funded, and delivered. without thoughtful planning, indiana could lose 30 id. 31 fssa: reports & statistics, ind. family and soc. servs. admin., http://www.in.gov/fssa/ddrs/3347.htm (last visited aug. 29, 2012). 32 id. 33 ind. comm'n on developmental disabilities, second meeting minutes, 117th gen. assemb., interim sess., at 6 (2011), available at http://www.in.gov/legislativelinterim/committee/minutes/ mrdde97.pdf. 34 hayden, supra note 20. 35 h.e.a. 1001, 117th gen. assemb., 1st reg. sess., chap. 45 § 4(a) (ind. 2011), available at http://www.in.gov/legislative/bills/2011/pdf/ he/he1001.1.pdf. 36 jd. 219 indiana health law review valuable ground in the provision of community-based services and significantly increase the risk of institutionalization for both those in community services and those waiting for services. adding to these pressures, there is mounting dissatisfaction among consumers and providers regarding the effectiveness of the current service delivery system. 37 highlighted by reports of state agencies staff "suggest[ing] leaving severely disabled people at homeless shelters if they can't be cared for at home," consumer and family groups have sought intervention from the state to address limitations within the current system. 38 in addition, these groups have set out on their own investing significant resources in identifying systemic alternatives that focus on employment, individual strengths, family support, creativity, and judicious use of resources. 39 providers have also expressed their dissatisfaction by launching a statewide public awareness campaign to highlight their concerns about the system and its impact on indiana's citizens with intellectual and developmental disabilities. 40 b. omstead's significance 1. oln stead's integration mandate using title ii of the ada as its basis, the united states supreme court responded with a "qualified yes" to the question of "whether the proscription of discrimination may require placement of persons with mental disabilities in com-munity settings rather than in institutions."41 more specifically, the court directed that 37 wilson, supra note 20. 38 indiana state workers suggest leaving disabled people at homeless shelters, supra note 20; see also hayden, supra note 20. 39 wilson, supra note 20. 40 inquietcrisis.org' about, inquietcrisis.org, http://www. inquietcrisis.org/page.cfm?id=21 (last visited sept. 1, 2012). 41 olmstead v. l.c. ex rel. zimring, 527 u.s. 581, 587 (1999) (plurality opinion). 220 vol. 10:1 2013 integrated care and the ada integration mandate [s]uch action is in order when the state's treatment professionals have determined that community placement is appropriate, the transfer from institutional care to a less restrictive setting is not opposed by the affected individual, and the placement can be reasonably accommodated, taking into account the resources available to the state and the needs of others with mental disabilities. 42 in olmstead, the plaintiffs asserted claims of discrimination related to their segregation in an institutional setting for the purposes of treatment. 43 both plaintiffs were dually diagnosed with mental retardation and mental illness and had been voluntarily admitted to georgia regional hospital at atlanta where they were "confined for treatment in a psychiatric unit."4 4 after a period of time, their treatment teams determined that their "needs could be met appropriately in one of the communitybased programs the state supported." 45 despite this determination, both "remained institutionalized."46 in considering whether the state's failure to transition the plaintiffs into a com-munity based treatment program was discriminatory, the court looked to title ii of the ada.4 7 the court pointed out that title ii requires that "no qualified individual with a disability shall, by reason of such disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of a public entity, or subjected to discrimination by any such entity."48 further, the court explored the effect of regulations issued by the united states attorney general in furtherance of title ii. specifically, the court noted two key portions of the regulation including the "integration 42 id. at 587. 43 id. at 594. 44 id. at 593. 45 id. 46 id. 47 id. at 589-90. 48 id. (quoting 42 u.s.c. § 12132 (west 2012)). 221 indiana health law review regulation," 49 which requires that "[a] public entity shall administer services, programs, and activities in the most integrated setting appropriate to the needs of qualified individuals with disabilities,"5 0 such that it "enables the individuals with disabilities to interact with non-disabled persons to the fullest extent possible."5 1 as well as the "reasonable-modification regulation" which "requires public entities to 'make reasonable modifications' to avoid 'discrimination on the basis of disability,' unless those modifications would entail a 'fundamental alteration.' 52 within the context of these regulations, the court held that "[ulnjustified isolation . . . is properly regarded as discrimination based on disability."53 however, the court qualified this conclusion in a few important ways. from a patient protection perspective, the court stated that "nothing in the ada or its implementing regulations condones termination of institutional settings for persons unable to handle or benefit from community settings."54 further, the court advised that "the ada is not reasonably read to impel states to phase out institutions, placing patients in need of close care at risk. nor is it the ada's mission to drive states to move institutionalized patients into an inappropriate setting, such as a homeless shelter . . . "55 from a state perspective, the court recognized "the states' need to maintain a range of facilities for the care and treatment of persons with diverse mental disabilities, and the states' obligation to administer services with an even hand."56 the court clarified that: sensibly construed, the fundamental-alteration component of the reasonable-modifications regulation would allow the state to show that, 49 id. at 592. 50 id. (quoting 28 c.f.r. § 35.130(d) (1998)). 51 id. (citation omitted); see also 28 c.f.r. § 35, app. a (2011)). 52 id. at 592. 53 id. at 597. 54 id. at 601-02. 55 id. at 604-05. 56 id. at 597. 222 vol. 10: 1 2013 integrated care and the ada integration mandate in the allocation of available resources, immediate relief for the plaintiffs would be inequitable, given the responsibility the state has undertaken for the care and treatment of a large and diverse population of persons with mental disabilities.57 importantly, the court indicated that "[tlo maintain a range of facilities and to administer services with an even hand, the state must have more leeway than" 58 a "simple comparison show[ing] that community placements cost less than institutional confinement." 59 rather, the court indicated that a state's "fundamental-alteration defense"60 should include "not only the cost of providing communitybased care to the litigants, but also the range of services the state provides others with mental disabilities, and the state's obligation to mete out those services equitably."61 furthermore, if, for example, the state were to demonstrate that it had a comprehensive, effectively working plan for placing qualified persons with mental disabilities in less restrictive settings, and a waiting list that moved at a reasonable pace not controlled by the state's endeavors to keep its institutions fully populated, the reasonable-modifications standard would be met.62 2. omstead's impact for those 'at risk of institutionalization" in the years following olmstead, courts have considered a variety of issues related to its 'integration mandate.' 57 id. at 604. 58 id. at 605. 5 id. at 604. 60 id. 61 id. at 597. 62 id. at 605-606. 223 indiana health law review these issues fall into two broad categories: those causing individuals to be "at risk of institutionalization," and those like the issues raised in olmstead, that prevent individuals the opportunity to receive services in the most integrated setting. 63 while states continue to make strides in rebalancing their service delivery systems and reducing their use of institutional settings, 64 significant challenges remain in addressing the demand for community-based services.65 for the states, these challenges in turn create significant exposure to waiting list dilemmas. generally, courts have held that olmstead applies to those individuals "at risk of institutionalization." 66 this view is also reflected in the doj's current guidance to the states on olmstead.67 in support of this assertion, courts have held that "the protections of the integration mandate 'would be meaningless if plaintiffs were re-quired to 63 smith, supra note 14, at 4. 64 kaiser comm'n on medicaid and the uninsured, moving ahead amid fiscal challenges: a look at medicaid spending, coverage and policy trends results from a 50-state medicaid budget survey for state fiscal years 2011 and 2012 full report 14 (2011), available at http://www.kff.org/medicaid/upload/8248.pdf. ("over the past two decades, spending on medicaid home and community-based services has been growing as more states attempt to reorient their long-term care programs by increasing access to home and community-based service options."). 65 nat'l council on disability, rising expectations: the developmental disabilities act revisited 30 (2011), available at http://www.ncd.gov/publications/20 11/feb 142011. 66 m.a.c. v. betit, 284 f. supp. 2d 1298, 1309 (d. utah, 2003); see also fisher v. oklahoma health care authority, 335 f.3d. 1175, 1182 (10th cir. 2003) ("we agree, and conclude that olmstead does not imply that disabled persons who, by reason of a change in state policy, stand imperiled with segregation, may not bring a challenge to that state policy under the ada's integration regulation without first submitting to institutionalization."). 67 u.s. dep't of justice, statement of the department of justice on enforcement of the integration mandate of title ii of the americans with disabilities act and olmstead v. l.c. (2011) [hereinafter statement of enforcement], available at http://www.ada.gov/olmstead/ q&aolmstead.pdf ("[tlhe ada and the olmstead decision extend to persons at serious risk of institutionalization or segregation and are not limited to individuals currently in institutional or other segregated settings."). 224 vol. 10:1 2013 integrated care and the ada integration mandate segregate themselves by entering institutions before they could challenge an allegedly discriminatory law or policy that threatens to force them into segregated isolation."'68 "at risk of institutionalization" claims often take the form of a challenge to a state's wait list. 69 the primary argument in these cases is that "placement .. . on the hcbs waiver waiting list threatens plaintiffs with institutionalization because it forces them to choose between staying in the community without any services or entering an institution in order to receive services."70 in addition, these challenges raise questions about the extent to which a state has an effective olmstead plan in place that includes assurances that the wait list "moves at a reasonable pace."7 ' the doj asserts that a "comprehensive, effectively working plan" includes "an analysis of the extent to which the public entity is providing services in the most integrated setting[,] . . . concrete and reliable commitments to expand integrated opportunities[] . . . specific and reasonable timeframes[,] ... measurable goals[,] ... funding to support the plan[, and] . . . commitments for each group of persons who are unnecessarily segregated." 72 further, "[t]he department of justice has inter-preted the ada and its implementing regulations to generally require an olmstead plan as a prerequisite to raising a fundamental alteration defense, particularly in cases involving individuals currently in institutions or on waitlists for services in the community."73 "at risk of institutionalization" claims also take the form 68 ma.c., 284 f. supp. at 1309 (citing fisher, 335 f.3d. at 1181); see also statement of enforcement, supra note 67, at 5 ("individuals need not wait until the harm of institutionalization or segregation occurs or is imminent."). 69 smith, supra note 14, at 4 (indicating a number of general access cases are related to wait lists). 70 ma. c, 284 f. supp. 2d at 1309. 71 bryson v. valias, no. civ. 99-558-m, 2004 wl 613027, at *3 (d.n.h. mar. 26, 2004). 72 statement of enforcement, supra note 67, at 6-7. 73 id. at 7. 225 indiana health law review of a challenge to a state's placing limitations on the type or amount of services available in the community. a common argument for such cases is that the limitation creates "a greater risk for institutionalization for those individuals who require [services beyond the limitation]."74 whether a challenge is raised as an "at risk of institutionalization" claim or is focused on the question of deinstitutionalization, many cases end with a settlement agreement, whereby the state agrees to modify its policies to increase the avail-ability of community services or to remove limitations.7 5 often, these agreements are on a scale that essentially rebalances the system of care away from institutional care and toward community-based services. 76 this often addresses the fundamental alteration issue, as it "help[s] the state leverage additional federal dollars, significantly expanding the total available funds for mental health services." 77 3. effect on medicaid medicaid is the primary funder of long-term services and supports for individuals with developmental disabilities, regardless of whether those services are provided in an institution or in the community.78 recognizing medicaid's "institutional bias", the centers for medicare and medicaid services ("cms") has invested a significant amount of time 74 pitts v. greenstein, no. 10-635-jjb-sr, 2011 wl 1897552, at *3 (m.d. la. may 18, 2011). 75 see generally smith, supra note 14 at 5-25 (describing the details of settlement agreements in connecticut, florida, hawaii, kentucky, maine, massachusetts, ohio, oregon, virginia, tennessee, texas, washington, and west virginia). 76 see u.s. dep't of justice, delaware ada settlement fact sheet 1 (jul. 6, 2011), available at http://www.ada.gov/delaware factsheet.htm ("the agreement will transform delaware's mental health system from one reliant on expensive, institutional care to one focused on cost-effective community-based services."). 77 id. at 2. 78 kaiser comm'n on medicaid and the uninsured, medicaid today; preparing for tomorrow a look at state medicaid program spending, enrollment, and policy trends 45 (2012), available at http://www.kff.org/medicaid/upload/8380.pdf. vol. 10:1226 2013 integrated care and the ada integration mandate and financial resources developing tools and other mechanisms to support states in rebalancing their systems toward community care. 79 these tools include a series of olmstead letters issued by cms to state medicaid directors, which attempt to clarify the opportunities and limitations of medicaid in helping states respond.80 these efforts present opportunities for states in terms of additional resources or increased federal funding.si the ohmstead court recognized medicaid's historical institutional bias, but pointed out that more recent policy was focused on the development of community-based services.82 the doj furthered this by clarifying that "[a] state's obligations under the ada are independent from the requirements of the medicaid program."83 in addition, the doj explained that "[p]roviding services beyond what a state currently provides under medicaid may not cause a fundamental alteration, and the ada may require states to provide those services, under certain circumstances." 84 4. implications for indiana given the current status of indiana's wait list for services, it seems an "at risk of institutionalization" challenge presents the most significant liability.85 however, 7 kaiser comm'n on medicaid and the uninsured, policy brief olmstead v. l.c.: the interaction 0 the americans with disabilities act and medicaid 3 (2004), available at http:// www.kff.org/medicaid/upload/olmstead-v-l-c-the-interaction-of-theamericans-with-disabilities-act-and-medicaid.pdf. 80 id 81 id. 82 olmstead v. l.c. ex rel. zimring, 527 u.s. 581, 587 (1999) (plurality opinion). 83 statement of enforcement, supra note 67, at 5 (citing dep't of health and human services, health care financing administration, smdl #01-006, olmstead update no. 4, at 7 (jan. 10, 2011), available at https://www.cms.gov/smdl/downloads/smd011 001a.pdf). 84 id. at 5. 85 see fssa statistics, indiana family and social services administration, http://www.in.gov/fssa/ddrs/3347.htm (last visited sept. 2, 2011) (indicating that the number of individuals receiving 227 indiana health law review the legislature's recent directive to address the per person and aggregate spending in the hcbs waivers for individuals with developmental disabilities may also present liability in terms of creating limitations on community services.86 this risk is compounded by the fact that indiana's olmstead plan has not been substantively addressed since 2005, calling into question whether the state could assert a viable fundamental alteration defense.87 iii. analysis a. medicaid managed care, special populations, and long term services and supports historically, medicaid managed care was used by states as a tool to "deliver and finance care for medicaid enrollees, with the goals of increasing access to care, improving quality, and in some cases, reducing costs." 88 medicaid managed care programs have typically not included individuals eligible by virtue of their disability, "because of their more involved needs, concerns about provider network adequacy, and limited health plan experience serving and bearing risk of this population."8 9 in addition, medicaid managed care programs have primarily focused on acute care services and rarely included long term services and services is nearly equal to the number of individuals waiting for services). 86 h.e.a. 1001, 117th gen. assemb., 1st reg. sess., at 212 (ind. 2011), available at http://www.in.gov/legislative/bills/2011/pdf/he/ he1001.1.pdf. 87 ind. comm'n on mental retardation and developmental disabilities, third meeting minutes, 114th gen. assemb., interim sess., at 3 (2005), available at http://www.in.gov/legislative/interim/ committee/2005/committees/minutes/mrdd89t.pdf. 88 kaiser comm'n on medicaid and the uninsured, a profile of medicaid managed care programs in 2010: findings from a 50state survey 1 (2011) [hereinafter medicaid managed care survey], available at http://www.kff.org/medicaid/upload/8220.pdf. 89 kaiser comm'n on medicaid and the uninsured, people with disabilities and medicaid managed care: key issues to consider 3 (2012) [hereinafter disabilities and managed care], available at http://www.kff.org/medicaid/upload/8278.pdf. 228 vol. 10:1 2013 integrated care and the ada integration mandate supports. 90 this is largely attributable to consumer concerns, provider reluctance, and the complexity of service design. 91 as applied to services for individuals with developmental disabilities, some have suggested that the incredible growth of community-based services in the 1990's "reduce[d the] pressure to introduce managed care techniques."92 today, most states and approximately two-thirds of all medicaid beneficiaries are involved in a comprehensive medicaid managed care program.93 medicaid managed care is beginning to encompass previously exempt or excluded beneficiaries, like "children with disabilities receiving supplemental security income (ssi), children with special health care needs, and seniors and people with disabilities who are not dually eligible for medicare and medicaid." 94 in addition, states are showing an increased interest in using medicaid managed care programs to manage long term services and supports.95 initial experience suggests that such models reduce institutional usage and increase access to community services, however, information about cost savings and impact on consumers is limited.9 6 as the adage goes, "if you've seen one state medicaid 90 kaiser comm'n on medicaid and the uninsured, examining medicaid managed long-term service and support programs: key issues to consider 4 (2011) [hereinafter mltss key issues], available athttp://www.kff.org/medicaid/upload/8243.pdf. 91 paul saucier & wendy fox-grage, issue brief number 79: medicaid managed long-term care 7 (2005), available at http://assets.aarp.org/rgcenter/il/ib79_mmltc.pdf. 92 robert m. gettings, the national leadership consortium on developmental disabilities policy insights expanded bulletin: reassessing the impact of managed care in the developmental disabilities sector 4 (2009) [hereinafter expanded bulletin] available at http://www.nlcdd.org/insights/policy-bulletinexpanded03o 509.pdf. 9 medicaid managed care survey, supra note 88, at 2. 94 id. 95 mltss key issues, supra note 90, at 1. 96 id. at 5. 229 indiana health law review program, you've seen one medicaid program," 97 this remains true when examining medicaid managed longterm services and supports (mltss) approaches. there are four primary federal authorities that permit states to implement medicaid managed care. 98 for the purposes of mltss, states primarily utilize waiver authority either under section 1915(a), section 1915(b), or section 1115 of the social security act. 99 under these authorities, states are given "flexibility to not comply with the following requirements outlined in medicaid law outlined in section 1902[, including] [s]tatewideness . . . [clomparability of [slervices . . . [or] [f]reedom of [c]hoice." 100 in addition, several states use the section 1915(b) authority to limit consumer choice by "specify[ing] the providers used" in combination with section 1915(c) authority for hcbs to "provide long-term care to specific populations, within specific geo-graphic areas and to specify the providers used."101 beyond which federal authority to utilize, additional options for states to con-sider are whether to make enrollment in managed care voluntary or mandatory and which model of managed care to implement.102 there are three primary models of medicaid managed care including: managed care organizations (mcos) [which are] like hmos, . . . [and] agree to provide most medicaid benefits to people in exchange 97 penelope lemov, opening up medicaid, governing (aug. 19, 2009), http://www.governing.com/topics/health-human-services/openingup-medicaid.html (last visited sept. 5, 2012). 98 managed care, medicaid.gov, http://www.medicaid.gov/ medicaid-chip-program-information/by-topics/deliverysystems/managed-care/managed-care.html (last visited sept. 2, 2012) (identifying that federal authorities permitting managed care include state plan authority under section 1932 of the social security act and waiver authority, as described above.) 99 see saucier & fox-grage, supra note 91. 100 managed care, supra note 98. 101 m. kitchener et al., medicaid managed long-term care: an introduction 3 (2006), available at http://www.pascenter.org/ publications/publicationhome.php?id=546&focus=paslibrary. 102 managed care, supra note 98. 230 vol. 10:1 2013 integrated care and the ada integration mandate for a monthly payment from the state[;] [11imited benefits plans [which] . . . may look like hmos but only provide one or two medicaid benefits (like mental health or dental services)[;] [and] primary care case managers [which are] . . . individual providers (or groups of providers) [that] agree to act as an individual's primary care provider, and receive a small monthly payment for helping to coordinate referrals and other medical services. 103 the factors attributed to these authorities and program design options contribute to the wide variation among state approaches to medicaid managed care, in general, and mltss, specifically. other critical considerations are the goals and outcomes the state is hoping to achieve by implementing mltss.104 states' goals often include controlling the growth of costs, increasing access to community services, reducing use of institutional services, creating funding predictability, limiting state financial risk, protection from adverse decisions, and increasing care coordination. 105 specific to those approaches using the combined authority under sections 1915(b) and 1915(c), opportunities exist in terms of improved efficiency and flexibility in resources; improved service quality; and improved opportunity for self-direction, while potential challenges include balancing costs with quality; lack of standards of practice; lack of data to use in 103 id. 104 ctr. for health care strategies, inc., profiles of state innovation: roadmap for managing long-term supports and services 11 (2010) [hereinafter profiles of state innovation], available at http://www.ches.org/usrdoc/mltsroadmap_112210.pdf. 105 robert l. kane et al., managed long-term care and the rebalancing of state long term support systems: topics in replacing state long-term care systems, topic paper no. 3 7 (2007), available at http://www.sph.umn.edu/hpm/1tcresourcecenter/ research/rebalancing/attachments/topicpapers/topic_3_implications of_ managedlongtermcare-forrebalancing.pdf. 231 indiana health law review setting capitation rates; supports are not always clinical in nature; and limitation on provider choice. 106 in terms of the outcomes realized, states most often report "improved access to care" as a result of medicaid managed care, in general. 107 while the impact on cost savings is mixed, most states report that "managed care offered the state improved value related to access and quality, even if savings were modest or not realized."10 similar patterns have been noted as a result of mltss.109 additionally, states have indicated that even if cost savings are not realized, they "value the increased predictability of spending under [mltss."1'0 1. state example wisconsin ' family care initiative since 1999, wisconsin has implemented its medicaid family care initiative, which includes "a capitated acute care and long-term managed care program for people with [intellectual and developmental disabilities] i/dd, older people, and young persons with physical disabilities.""1 the family care initiative is operated under a combined 1915(b) and 1915(c) waiver authority1 l 2 through contracted managed care organizations. 113 the state identifies four goals for its family care initiative including improving consumer choice, improving access, improving quality, and 106 john agosta et al., information brief: opportunities and challenges presented by utilizing a combined 1915(b)/(c) waiver 4-5 (2010), available at http://www.nc-ddc.org/ publications/combined-bc-waivers-opportunities-and-challenges.pdf. 107 medicaid managed care survey, supra note 88, at 16. 108 id. at 17. 109 saucier & fox-grage, supra note 91, at 8-10 (recognizing that mltss outcomes include increased access to home and community based services, decreased use of high cost services, mixed results in terms of cost savings, and modest, yet positive, quality outcomes). 110 id. at 9. 111 braddock, supra note 18, at 37. 112 health mgmt. assocs., final report pilot to serve persons with intellectual and developmental disabilities 10 (2010), available at http://www.hhsc.state.tx.us/reports/managed-carepilot.pdf. us expanded bulletin, supra note 92, at 8. 232 vol. 10:1 2013 integrated care and the ada integration mandate achieving cost effectiveness. 114 however, the literature suggests that improving access by reducing and/or eliminating waiting lists is the state's primary goal.115 wisconsin has a variety of statutes that address the design, delivery, and funding for the family care initiative. 116 the statutes provide the state with the authority for pursuing managed care, 117 an overall framework for the program, and important consumer protections. 118 these protections include the creation of regional long-term care advisory committees governed by a board of directors whose members include either persons served or their families and advocates.119 the committees' duties include oversight, monitoring, and long-range planning for their identified region. 120 the statutes also provide for advocacy services that would provide information, technical assistance, and support in negotiations, mediations, and individual case advocacy to family care participants.121 a host of regulations have been published pursuant to this statutory framework. these regulations provide additional guidance and direction on standards for performance, eligibility determination, care management organizational standards and operational 114 family care home page, dhs.wisconsin.gov, http://www. dhs.wisconsin.gov/ltcare/ (last visited sept. 3, 2011). 115 profiles of state innovation, supra note 104 at 4 (indicating that wisconsin identified decreasing wait lists as a driver for moving to mltss); see also expanded bulletin, supra note 92, at 8. 116 family care statutes, wis. dep't of health serv, http://www. dhs.wisconsin.gov/ltcare/ statefedreqs/statutes.htm (last visited sept. 5, 2012). 117 wis. stat. § 46.281(1d) (west 2012) (directing the state agency to seek approval for the use of federal funds to support the family care initiative). 118 see robert m. gettings, the national leadership consortium on developmental disabilities policy insights short bulletin: reassessing the impact of managed care in the developmental disabilities sector 4 (2009) [hereinafter short bulletin], available at http://www.nlcdd.org/insights/policy-bulletinshort030509.pdf. 119 wis. stat. § 46.2825(1) (west 2012). 120 wis. stat. § 46.2825(2) (west 2012). 121 wis. stat. § 16.009 (west 2012). 233 indiana health law review requirements, and client rights and protections.122 implementation of the program began on a pilot basis "in a limited number of counties and [was] evaluated before legislative authority was sought to implement the program statewide."123 the state "announced plans to implement the family care program statewide by 2011" 124 as a result of a program evaluation that revealed that: family care had . . . (a) substantially increased participant choice and access to needed services, while improving quality by focusing on social outcomes; (b) eliminated waiting lists for services in the participating counties; (c) improved access to information concerning long-term service options among target populations; (d) achieved a high level of consumer satisfaction; and (e) saved an average of $452 per month, per participant in four out of the five participating counties when compared to previous fee-for-service funding arrangements. 125 more recently, in the face of budget constraints and difficulty in assessing the programs cost-effectiveness, the state attempted to cap enrollment in the program.126 as a result, waiting lists in counties covered by the family care program were established. 127 however, cms has since directed the state to lift the cap and enroll those negatively impacted by its implementation, as hcbs waivers under the state's current program design are considered an 122 see generally wis. admin. code dhs § 10.13 (west 2008) (containing detailed regulations for each of the areas identified above.). 123 short bulletin, supra note 118, at 4. 124 id. 125 id. 126 patrick marley & guy bulton, walker plans to lift cap on long-term care, milwaukee j. sentinel dec. 29, 2011, htitp://www.jsonline.cominews/statepolitics/walker-proposes-tolift-cap-on-longterm-care-program-oc3jlco136317513.html. 127 id. 234 vol. 10:1 2013 integrated care and the ada integration mandate entitlement and cannot be limited in such a fashion. 128 2. state example michigan's combination 1915(b)/(c) medicaid prepaid specialty services and supports for persons with developmental disabilities michigan has implemented services through various forms of managed care for over twenty years. 129 during the 1990s, the state transitioned their managed long-term care program under a combined section 1915(b) and section 1915(c) authority.130 under this combined authority, michigan provides a "comprehensive, prepaid, capitated managed care network . . . administered by local government community mental health services programs." 131 the state's intent for implementing a managed care approach was to provide "greater flexibility in administering state and federal funds." 132 as a result of this flexibility, "[tihe michigan waiver affords a uniform package of benefits for people with i/dd, allowing the state to remove the artificial distinctions between medicaid state plan benefits and medicaid hcbs waiver benefits."133 like wisconsin, michigan's approach includes various consumer protections. from a statutory standpoint, michigan's mental health code prescribes the process of using person-centered planning to "establish meaningful 128 letter from verlon johnson to brett davis (dec. 13, 2011), assoc. reg'1 admin'r, ctrs. for medicare and medicaid servs., div. of medicaid and children's health operations, at 1, available at http://www.jsonline.com/news/statepolitics/walker-proposes-to-lift-capon-longterm-care-program-oc3jlco-136317513.html (then follow "related document" hyperlink). 129 short bulletin, supra note 118, at 4 (in addition to serving individuals with intellectual and developmental disabilities, michigan's program serves individuals with mental illness and individuals with substance abuse.). 130 id. at 3. 131 braddock, supra note 18, at 33. 132 short bulletin, supra note 118, at 2. 133 braddock, supra note 18, at 33. 235 indiana health law review and measurable goals with the recipient."134 as requested by the recipient, the plan should address the need for "food, shelter, clothing, health care, employment opportunities, educational opportunities, legal services, transportation, and recreation." 135 in addition, through the contracting process the state "affirmatively requires that community mental health services programs . . . ensure that individuals with i/dd can choose among service providers and that consumer service plans are developed using person-centered planning principles."13 6 from an outcome perspective, community mental health services programs are not permitted to maintain waiting lists. rather, they are required to identify and connect or provide the services needed by the individual.137 as a result, michigan serves over 39,000 individuals with intellectual and developmental disabilities through their managed care program. 138 further, an evaluation of the program indicated that while perhaps modest, savings were achieved by transitioning to the managed care approach. 139 3. state example pennsylvania ' adult community autism program pennsylvania has recently implemented a managed longterm care approach targeted at serving a limited number of individuals with autism within a limited geographic area.140 unlike michigan and wisconsin, pennsylvania's program is 134 mich. comp. laws § 330.1712 (west 2012). 13 id. 136 braddock, supra note 18, at 33. 137 mich. developmental disabilities council, developmental disabilities five-year strategic plan: fiscal years 2007-2011 14 (2007), available at www.michigan.gov/documents/mdchl5-yrstateplan179395_7.pdf. 138 health mgmt. assocs., supra note 112, at 9. 139 id. 140 acap general information questions, pa.gov, http://www.dpw.state.pa.us/foradults/autismservices/adultcommunity autismprogramacap/acapgeneralinformationquestions/index.htm (last visited sept. 5, 2012) (stating that the program is currently limited to two hundred clients and serves only four counties). 236 vol. 10:1 2013 integrated care and the ada integration mandate operated under the 1915(a) waiver authority. 141 the goals for the program include a variety of programmatic outcomes oriented at improving independence and com-munity integration.142 like michigan, the program uses a prepaid inpatient health plan approach and requires capitation rates to be actuarially sound. 143 a unique feature of pennsylvania's approach is that the managed care entity is solely responsible and services are "dis-intermediated," meaning there is no intermediary between the individual and the managed care entity/provider. 144 in addition to long-term services and supports, the managed care entity is responsible for "hospital, diagnostic, laboratory, and pharmacy services . . . as well as psychologists and nutritionists."14 5 similar to other state's approaches, the pennsylvania approach includes a variety of consumer safeguards. 146 these safeguards include formal consumer oversight, annual cost reviews, and requirements for highly qualified, specially-trained staff.147 additionally, the program includes a variety of agreed upon outcomes related to ensuring a high quality experience for participants, 148 including ensuring "care plans are developed pursuant to comprehensive diagnostic and functional assessment of need."149 in terms of outcomes, the program has realized increases in "reduced levels of behavioral challenges, increased moves to independent living, and higher levels of competitive employment."15 0 from the state perspective, the 141 danna mauch et al., report on state services to individuals with autism spectrum disorders (asd): final report 60 (2011), available at http://www.cms.gov/apps/files/9-state-report.pdf. 142 acap general information questions, supra note 140. 143 robert j. baker, president/ceo, keystone autism services, presentation at ancor leadership summit 13 (oct. 2011). 144 id. at 21. 145 mauch et al., supra note 141, at 59. 146 baker, supra note 143, at 19-20. 147 id. 148 id. at 14-16. 149 mauch et al., supra note 141, at 61. 150 id. at 62. 237 indiana health law review program provides fiscal predictability.15 1 from the provider perspective, the program has profitability.152 achieved a consistent level of table comparison: key features of state examples wisconsin michigan pennsylvani a managed mco pihp pihp care model waiver 1915(b)/(c) 1915(b)/(c) 1915(a) authority primary reduce/eliminat flexibility in improve goal e waitlists administerin consumer g funding independenc e and community integration population people with people with people with s served i/dd, older i/dd, people autism persons, and with mental young persons illness, and with physical people disabilities experiencing substance abuse. scope acute care acute care acute care and longand longterm care term care waitlist no no unknown, but program is capped at 200 consumers 151 baker, supra note 143, at 27. 152 id. at 18. 238 vol. 10:1 2013 integrated care and the ada integration mandate iv. lessons and implications for state approaches to dd services a. general recommendations olmstead continues to be a driving force in assuring the rights of individuals with disabilities in securing and receiving community-based treatment. 153 in working to meet olmstead's "integration mandate" within the context of increasing fiscal pressures, states must be creative in designing meaningful and fiscally sustainable communitybased supports. while not a panacea, medicaid managed long-term services and supports may provide states with an effective tool in meeting this challenge. 154 1. stakeholder engagement in order to be effective, states should engage in a thoughtful re-design process that involves stakeholders and advocates in all aspects of planning, design, and implementation. 155 cms identified engaging program recipients in "system planning, policy development, local 153 see generally olmstead: community integration for everyone, ada.gov, http://www.ada. gov/olmsteadlindex.htm (last updated jan. 12, 2012). 154 ctrs. for medicare and medicaid servs., state medicaid directors letter no. 10-008, community living initiative 3 (2010), available at http://downloads.cms.gov/cmsgov/archived-downloads/ smdl/downloads/smd10008.pdf ("cms continues to identify service delivery models that can be used to further the goals of the ada. one such tool, when structured carefully, is managed care."); see generally nancy thaler, presentation at intellectual and developmental disabilities hcbs leadership summit 28 (nov. 29, 2011), available at http://www.opra.org/clientuploadsupdates/news%20articles/old%20 news%20articles%20prior%20to%206-8-2012/cms%20region %205%200hio%2011%2029%2011%2onancy.pdf. 155 jeffrey s. crowley, the national association of people with aids, building strong medicaid managed care contracts: a guide to help consumer advocates participate in strengthening hiv/aids provisions in managed care contracts 13 (2000), available at http://www.kff.org/medicaid/loader.cfm?url=/commonspot/ security/getfile.cfm&pageld=13516. 239 indiana health law review program management, and quality assessment" as a promising practice in system change and reform. 156 in both michigan and wisconsin, participant involvement is an integral part of the oversight and management of their respective programs. 157 additionally, it is important to engage provider organizations traditionally involved in meeting the long term services and support needs of individuals with i/dd, given their "strong ties with consumers."1 58 extensive stakeholder involvement supports the development of a shared vision for system redesign. most states indicate that establishing a clear goal or objective is crucial. 159 a shared vision provides "a framework for policy development and subsequent discussions with stakeholders." 160 also, a shared vision can help communicate the primary purpose for the redesign and manage expectations. 161 2. memorializing the program in statute one way to ensure stakeholder input and preservation of the program's goals is through the legislative process. 162 states who have used this approach report "that the process of getting legislative approval was an important opportunity to ensure that the state's vision for mlts[s1 was communicated and understood in a very public way."168 15 steve eiken, promising practices in long term care systems reform: common factors of systems change 2 (2004), available at http://www.hcbs.org/files/56/2766/ comparativeanalysis1213-04.pdf. 157 id. at 2-3. 158 disabilities and managed care, supra note 89, at 8. 159 profiles of state innovation, supra note 104, at 11. ("by initially focusing on the end goal e.g., providing greater choices for receiving care in the community rather than the method for getting there, the state could build support for the overall program before having to address potential stakeholder concerns regarding managed care."). 160 eiken, supra note 156, at 3. 161 disabilities and managed care, supra note 89, at 8. 162 profiles of state innovation, supra note 104, at 9. 163 id. 240 vol. 10:1 2013 integrated care and the ada integration mandate additionally, having the program reflected in statute ensures that any significant changes are also made through a transparent process with ample opportunity for stakeholder input and feedback. 3. quality measurement given the focus on outcomes and safeguards, an effective mltss should include a meaningful quality measurement system. 164 if planned through the lens of olmstead, a meaningful quality measurement system would focus on key issues related to rate of institutionalization, number of individuals living in settings of choice, number of individuals engaged in integrated community employment, and other indicators that demonstrate effective communitybased supports.165 additionally, these systems should also monitor access to care and consumer satisfaction. 166 b. indiana specific considerations indiana's approach to services for individuals with intellectual and developmental disabilities is unsustainable. 167 the current focus on delivering home and community-based services through a fee-for-service model misaligns incentives. 168 specifically, such a model encourages maximizing resources on those within the service delivery system with no incentives to reach those on the outside waiting for services. 169 compounding this concern, when individuals do enter services it is usually 164 mltss key issues, supra note 90, at 2. 165 see generally statement of enforcement, supra note 67, at 5. 166 letter from gov't accountability office, to sens. grassley and baucus and reps. barton and dingell, medicaid managed care: access and quality requirements specific to low-income and other special needs enrollees 1 (dec. 8, 2004), http://www.gao.gov/new.items/d0544r. pdf. 167 see generally wilson, supra note 20; h.e.a. 1001, 117th gen. assemb., 1st reg. sess., at 212 (ind. 2011), http://www.in.gov/ legislative/bills/2011/pdf/he/he1001.1.pdf. 168 expanded bulletin, supra note 92, at 34. 169 id. 241 indiana health law review because they are in crisis and in need of a significant amount of support, 170 which translates into significant financial resources. as a result, the finite resources available for these critical services fail to mean-ingfully reach those not in crisis and waiting for services within a reasonable time frame. this failure significantly increases indiana's olmstead liability as it relates to an access to services challenge. further, indiana's olmstead liability also increases proportionately to the extent that those in crisis are redirected to nursing facilities, large private icfs/mr, and other institutional based services due to limited hcbs capacity. while mltss is not without its concerns, it could help to address these concerns by bringing stable, predictable, and reliable access to services. 171 1. olmstead as a framework as reflected in the court's opinion in olmstead and in the doj's subsequent guidance, having an "effective olmstead plan" in place is critical in having a viable defense against an olmstead challenge. 172 the elements of an effective olmstead plan, as identified by the doj, provide a useful framework for thinking about how mltss could be implemented.1 73 based on the experience of other states, transition to this model represents a radical transformation 170 see generally ddrs: quarterly update, supra note 1, at 2 (asserting that the only opportunity to enter the community integration and habilitation waiver is when an individual meets certain priority/emergency criteria). 171 see generally expanded bulletin, supra note 92; saucier & fox-grage, supra note 91. 172 olmstead v. l.c. ex rel. zimring, 527 u.s. 581, 605-06 (1999) (plurality); see also statement of enforcement, supra note 67, at 7. 173 statement of enforcement, supra note 67, at 6-7 (finding that a "comprehensive, effectively working plan" includes "an analysis of the extent to which the public entity is providing services in the most integrated setting[;] . . . concrete and reliable commitments to expand integrated opportunitiesl;] ... specific and reasonable timeframes[] . . . measurable goals[;] . . . funding to support the plan[; and] . . . commitments for each group of persons who are unnecessarily segregated."). 242 vol. 10: 1 2013 integrated care and the ada integration mandate of the service delivery system.174 key components of this transformation include "craft[ing] solutions that address the unique contours of the state's needs moving forward" and ensuring the system's values are clearly articulated. 175 approaching the transformation through the lens of an olmstead plan would help ensure that its focus was on promoting access to community-based, integrated services and mitigating those issues that put individuals "at risk of institutional-ization." 176 like wisconsin, a natural extension of this activity would be to "hav[e] the program's goals 'carved in stone' "177 by incorporating the system's current guiding principles of self-advocacy and selfdirection; quality integration and quality outcomes; work first and meaningful day; and dignified risk and risk manage-ment178 into authorizing legislation. 179 further, in recognition of the system's limitations motivating the transition to managed care, the authorizing legislation should also incorporate a focus on statewide access to services and creating predictable and stable funding. 2 promoting access to services after establishing the underlying values and goals of transitioning to mltss, the planning focus can shift into specifically addressing access to services through program design. "[e]nhanced statewide equity in access to services . . was a primary motivator behind several states moving to a mltss approach. 180 at a most basic level, transitioning long-term care services from traditional fee-for-service into managed care essentially transforms them into an 174 expanded bulletin, supra note 92, at 39. 175 idat 41. 176 statement of enforcement, supra note 67, at 7. 177 expanded bulletin, supra note 92, at 41. 178 ddrs mission, vision, & guiding principles, in.gov, http:// www.in.gov/fssa/ddrs/3341.htm (last visited aug. 28, 2012). 179 expanded bulletin, supra note 92, at 41 42. 180 dat 45. 243 indiana health law review entitlement1 81 by requiring states to take an "all-comers" approach to enrolling individuals into services. 182 as a result, the approach has been relatively effective at eliminating wait lists.183 3. integrated funding further, an identified success of mltss is that it permits the myriad of federal, state, and local funding streams to be combined into a "single, flexible benefit package" that provides "latitude to develop more individually tailored support plans."18 4 this flexibility shifts the systems incentives away from "overserv[ing] eligible clients" and toward "figuring out how the appropriate array of services and supports could be provided to each individual in the most economical manner given his or her needs and preferences."1 8 5 additionally, it incentivizes "interven[tion] [before] a major life crisis occurs."186 some states believe that this has been an important reason in their ability to ''maintain . . . a low rate of institutionalization over the years."187 the ability to transform home and community-based services into an entitlement and to provide maximum flexibility in combining and deploying resources combine to make mltss a powerful tool for ensuring access to services. if integrated into indiana's omstead plan, the state could provide compelling evidence of their "concrete and reliable commitments to expand integrated 181 wis. dep't of health servs., long-term care in motion: 2009 annual report of wisconsin's long-term care programs 10 (2009), available at http://www.dhs.wisconsin.gov/ltcare/reports/pdf/ 2009annualreport.pdf. 182 expanded bulletin, supra note 92, at 45 ("[a] managed care plan can be a vehicle that affords all eligible individuals reasonably prompt access to the long-term supports they need."). 183 mltss key issues, supra note 90, at 1. 184 expanded bulletin, supra note 92, at 34. 185 id. 186 id. at 35. 187 id. vol. 10:1244 2013 integrated care and the ada integration mandate opportunities." 188 the shift in incentives reflects the plan's values and focuses the system on supporting all individuals in need of service. in addition to promoting access, the plan should also address how the state intends to mitigate the risk of institutionalization. as previously identified, the shift in incentives to intervene prior to a crisis resulting from more integrated funding under a mltss model will go a long way towards achieving this outcome. 189 additionally, the managed care framework provides incentives to divert individuals away from institutionally based care like nursing facilities and large private icfs/mr and toward the creation of robust home and community-based support options. 190 4. central point ofaccountabiity lastly, mltss promotes the ability to "establish[] a fixed point of accountability" relative to meeting performance expectations, 191 including those focused on reducing reliance on institutional placements. coupled with an integrated funding stream, this fixed point of accountability aligns financial incentives with improved consumer outcomes and quality care. 192 following the lead of all three state examples, it may be useful to fix this single point of accountability on the existing i/dd provider community by using them as the managed care entity. 19 3 the benefit of this approach is twofold. first, the system benefits from the i/dd provider communities' expertise with individuals with i/dd and the types of services and supports they require. 194 second, given the limited 18 statement of enforcement, supra note 67, at 7. 189 expanded bulletin, supra note 92, at 35. 190 id at 34. 191 idat 35. 192 see generally baker, supra note 143, at 25-26. 193 health mgmt. assocs., supra note 112, at 13; mauch et al., supra note 139, at 59. 194 disabilities and medicaid managed care, supra note 87, at 8. 245 indiana health law review opportunities for cost savings, 195 using this "disintermediated" approach eliminates intermediaries between the consumer, provider, and state agency, thus reducing administrative cost in the system.196 developing an indiana mltss model with reference to an effective olmstead plan provides a meaningful framework to "'think holistically' about the changes associated with the transition to a managed care system."9 in addition to providing a viable defense against potential omstead challenges, this approach increases the likelihood that the development of managed care remains closely tied to its underlying values. further, as recommended by states that have implemented man-aged care, the planning process could provide a platform for engaging stakeholders in both the development and implementation of the resulting model. 198 together, the underlying values and stakeholder involvement provide reasonable assurances that many of the potential issues and pitfalls experienced by other states can be effectively considered and hopefully mitigated.199 v. conclusion having over 8,000 individuals with developmental disabilities waiting for community-based services poses a significant liability for indiana in terms of exposure under olmstead's integration mandate. further, the current pressure from indiana's general assembly to reduce the per person and aggregate spending under the hcbs waiver for individuals with developmental disabilities, increases the possibility that indiana could enact policy and funding changes that would put individuals "at risk of institutionalization." indiana's exposure to a possible olmstead suit increases in proportion to the increased risk of institutionalization resulting from these changes. mltss models have demonstrated success in increasing access to 195 id. 196 baker, supra note 143, at 21. 197 expanded bulletin, supra note 92, at 42. 198 id. 199 see generallyid. vol. 10:1246 2013 integrated care and the ada integration mandate services and effectively eliminating wait lists in the jurisdictions in which its been implemented. further, while the evidence on cost savings associated with mltss is mixed, it does appear that the model brings stability and predict-ability to home and community-based services. combined, these outcomes serve as powerful evidence of the potential for mltss to be an effective tool in empowering indiana to proactively transform its system, to avoid an olmstead challenge that would likely result in a court dictated program redesign, and most importantly to meaningfully provide access to services when, where, and how they are needed to support all indiana citizens with intellectual and developmental disabilities at home, at work, and in their communities of choice. for george, brenden, and the over 8,000 indiana citizens waiting for services, mltss could be the key to provid-ing them access to the right services at the right time, so that they do not miss out on vital opportunities for personal development and can fully realize their potential. 247 negligent credentialing as a cause of action in indiana medical malpractice litigation negligent credentialing as a cause of action in indiana medical malpractice litigation lindsey stout* i. introduction................................... 250 a. roadmap .............................. .... 252 b. background................................ 252 ii. indiana case law and guidance in negligent credentialing actions ..................... .... 253 iii. current trends in negligent credentialing from other jurisdictions ...................... ...... 260 a. bifurcation ..................................... 260 b. qualified immunity................... ........ 265 c. negligent credentialing and the peer review process............ .................... ..... 267 1. minnesota's interpretation of the peer review privilege in negligent credentialing claims......... 269 2. texas's interpretation of the peer review privilege in negligent credentialing claims ................ 272 3. iowa's interpretation of the peer review privilege in negligent credentialing claims ................ 275 4. missouri's interpretation of the peer review privilege in negligent credentialing claims......... 277 d. statutory immunity...................... 281 1. utah's negligent credentialing statute.... .... 281 2. ohio's negligent credentialing statute.... .... 282 iv. negligent credentialing and the affordable health care act............................... 284 v. conclusion ............................... ..... 286 * j.d. candidate, 2013, indiana university robert h. mckinney school of law; b.s., 2006, purdue university. indiana health law review i. introduction the concept of negligent credentialing has been around since the 1965 landmark decision by the illinois supreme court in darling v. charleston memorial hospital i however, the courts have slowly accepted negligent credentialing as a cause of action. as of june 2011, at least 28 states now recognize it as a valid cause of action.2 due to the slow growth in this cause of action, there is no clear guidance on how these cases should be handled by the courts. unfortunately, state courts are not in agreement as to how negligent credentialing claims should be handled and litigated, and of those states that have adopted negligent credentialing as a cause of action, some state supreme courts have not even had the chance to render decisions on these claims.3 negligent credentialing is "the theory in which the recipient of harmful service recovers from a gatekeeping entity for allowing the provider of that service to engage in the activities that caused the recipient harm."4 in order for doctors to treat their patients at a hospital, the hospital must grant the physicians credentials and privileges to admit patients and perform certain procedures.5 the recent trend toward integration of health care facilities and offices has interrupted the privileges of immunity that once protected health care institutions, and has opened a new era of litigation involving hospital liability for physician errors.6 i elam v. coll. park hosp., 183 cal. rptr. 156, 164 (cal. ct. app. 1982) (citing darling v. charleston cmty. mem'i hosp., 211 n.e.2d 253, 258 (ill. 1965)). 2 estate of burton v. trover clinic found., inc., no. 2009-ca-001595-mr, 2010 wl 6816338, at 2 (ky. ct. app. june 10, 2011). 3 see andrew r. deholl, vital surgery or unnecessary procedure? rethinking the propriety of hospital liability for negligent credentialing, 60 s.c. l. rev. 1127, 1132 (2009) (explaining that some states allow negligent credentialing claims, some states do not allow the action due to the state's privilege or immunity statutes, and some states recognize the cause of action, but effectively nullify it through granting peer review privileges to hospitals). 4 id. at 127. 5 42 c.f.r. § 422.204. 6 benjamin j. vernia, annotation, tort claim for negligent credentialing ofphysician, 98 a.l.r.5th 533 (2002). 250 vol. 10:1 negligent credentialing as a cause of action historically, physicians working in hospitals were classified as independent contractors, meaning they were permitted to work at the hospital and were given use of the hospital's facility and equipment, but the hospital had no control over the physician, and therefore, no liability pertaining to the physician's actions.7 however, the integration of healthcare has led to the formation of business relationships between hospitals and physicians, such that now physicians are sometimes employees of the hospitals they are credentialed to work in.8 the problem with integration, as it pertains to medical malpractice claims, is that it is often unclear as to where the actions of the hospital end and where the actions of the physician begin when evaluating negligence actions and what could have been avoided.9 negligent credentialing is one cause of action that seeks to determine the liability of hospitals in medical malpractice claims.10 currently, it is estimated that "j]ust six percent of doctors are responsible for nearly sixty percent of all medical negligence." 1 additionally, "two-thirds of doctors who make ten or more medical negligence payments are never disciplined." 12 furthermore, since the creation of the national practitioner databank in 1990, created for hospitals to report adverse physician events, about half of all u.s. hospitals have not even reported a single event.13 based on these statistics, there is a clear discrepancy between what is happening and what is being reported. hospitals have a duty of care to patients and allowing 7 whitney foster, note, health law-negligent credentialing and you: what happens when hospitals fail to monitor physicians, 31 u. ark. little rock l. rev. 321, 323 (2009). 8 kevin kavanagh, health care integration: will physicians lose their voice?, 96 bull. of the am. coll. of surgeons 28 (2011). 9 lyle griffin woodruff, hospital liability, warshauer law group, http://www.warlawgroup.com/files/ lgw-hospitalliability.pdf (last visited oct. 5, 2012). 1o vernia, supra note 6. 1' amer. ass'n for justice, medical negligence: the role of america's civil justice system in protecting patients' rights, 4 (2011), available at http://www.justice.org/resources/medicalnegligence primer.pdf. 12 id " id. at 4, 6. 2013 251 indiana health law review negligent credentialing as a cause of action against hospitals promotes an additional layer of protection to patients against avoidable medical errors and helps to keep hospitals accountable in the role of patient safety. 14 a. roadmap this note discusses negligent credentialing as a cause of action in medical malpractice claims. section ii looks to indiana case law as it pertains to negligent credentialing and the guidance that the decided cases in indiana give in regard to defendant and plaintiff actions. in order to better understand negligent credentialing as a cause of action and the future of this type of claim, section iii explores current trends in negligent credentialing in other jurisdictions and argues for three changes to indiana law: (1) the bifurcation of negligent credentialing claims; (2) a clarification on the peer review privilege; and (3) for a negligent credentialing statute to protect plaintiffs. indeed, indiana has looked to neighboring jurisdictions for guidance on how to rule in this type of action and will be likely to do so as further issues arise in negligent credentialing actions.15 section iv looks to how the enactment of the patient protection and affordable care act (ppaca) could impact negligent credentialing in indiana cases.16 b. background darling v. charleston community memorial hospital, decided in 1965, was the first case to recognize negligent credentialing as a cause of action in medical malpractice claims.17 the indiana court of appeals was slow to recognize negligent credentialing as a cause of action, but 14 vernia, supra note 6; see also deborah lavalley, why credentialing matters for patient safety, harv. crico/rmf forum, oct. 2006, at 1. 15 beswick v. bell, 940 n.e.2d 338, 345 (ind. ct. app. 2010). 16 patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119-1025 (2010). 17 elam v. coll. park hosp., 183 cal. rptr. 156, 164 (cal. ct. app. 1982) (citing darling v. charleston cmty. mem'1 hosp., 211 n.e.2d 253, 258 (ill. 1965)). 252 vol. 10:1 negligent credentialing as a cause of action eventually ruled that there is a valid cause of action in medical malpractice claims in 2000.18 in 2010, the indiana court of appeals decided a case that broadened the scope of factual foundations under which a plaintiff can bring a negligent credentialing action.19 the indiana supreme court has not yet heard a case on negligent credentialing. therefore, the only guidance afforded to the lower courts is from the few decisions that have been decided through the indiana court of appeals, unless the lower court looks to another jurisdiction's rulings as demonstrated by the court in beswick v. bell.2 0 the lack of guidance from the indiana supreme court and the lack of cases involving this cause of action leave the issue of what exactly is required in a negligent credentialing claim, the adjudicative process that is afforded in these claims, and issues of privilege and discovery open for debate. thus far, the decisions seem to render more questions than answers. ii. indiana case law and guidance in negligent credentialing actions since 1938, the common law rule in indiana was that a hospital is generally not liable for the medical negligence of the doctors on its staff, since by law, doctors are considered to be independent contractors. 21 however, in 1986, yaney v. mecray memorial hospital provided an exception to that common law rule. 22 the court in yaney held that a hospital could be liable for medical malpractice of its physicians if the hospital was aware that the care provided by a physician had deviated from the normal practice. 23 in determining whether the hospital could be found negligent, the court looked to whether the hospital's acts or omissions could be a proximate cause of the plaintiffs injuries. 24 the 18 winona mem'1 hosp. v. kuester, 737 n.e.2d 824, 828-29 (ind. ct. app. 2000). 19 beswick v. bell, 940 n.e.2d 338 (ind. ct. app. 2010). 20 id. 21 iterman v. baker, 15 n.e.2d 365, 370 (ind. 1938). 22 yaney v. mccray mem'1 hosp., 496 n.e.2d 135 (ind. ct. app. 1986). 23 id. at 137. 24 id 2013 253 indiana health law review court stated: the test for determining whether a negligent act or omission is the proximate cause of an injury is whether the injury is a natural and probable consequence, which in light of the circumstances, should have been foreseen or anticipated. the key is foreseeability of the ultimate injury as a natural and probable consequence of the act or omission.25 while this case did not include negligent credentialing as one of the causes of action, it opened the door for hospital negligence in medical malpractice claims and, eventually, the recognition of negligent credentialing as a cause of action. winona memorial hospital v. krueger is the landmark indiana case that adopted negligent credentialing as a cause of action in medical malpractice claims.26 the issue here was whether a negligent credentialing claim fell within the purview of the indiana medical malpractice act (the act).27 the court looked to the definition of "malpractice" under the act and then looked to the statute covering credentialing to determine if credentialing of a physician could fall under the act. 28 since the credentialing process involves both medical and nonmedical personnel and expertise, the court stated that it was "neither clearly within the act nor outside of it."29 in order for a negligent credentialing cause of action to continue, "[t]he credentialing process alleged must have resulted in a definable act of medical malpractice that proximately caused injury to [the plaintiff] ."30 the court reasoned that a complaint of negligent credentialing is subject to a medical review panel as required by the act: 25 id. at 138. 26 timothy c. curess & katherine amy lemon, recent developments in indiana tort law, 35 ind. l. rev. 1583, 1591 (2002). 27 id. at 825. 28 id. at 826-27. 29 id. at 827. 30 id. at 828. 254 vol. 10:1 negligent credentialing as a cause of action because the act of credentialing and appointing licensed physicians to its medical staff is a service rendered by the hospital in its role as a health care provider, inclusion of negligent credentialing under the act is consistent with use of the medical review panel to establish the standard of care owed by winona in credentialing. 31 further, the court held that the credentialing of a physician was "directly related to the provision of health care, and is therefore, not excluded from the act" as a cause of action in medical malpractice claims. 32 the importance of the winona case lies not only in that it recognized negligent credentialing as a cause of action, but also gave courts the guidance that negligent credentialing claims have to follow the statutory requirements of medical malpractice claims as listed in the act. in 2007, the federal courts in indiana revisted the matter of negligent credentialing in pike v. decatur memorial hospital.33 this case turned on the issue of who could be considered a "health care provider" under the act in order to satisfy the requirements for bringing a negligent credentialing claim. 34 since winona established that negligent credentialing claim could be brought under the act, it is only valid against "health care provider" as defined by the act. 35 in pike, the hospital had contracted with a third party company, nes, to find and provide it the service of emergency room physicians. 36 the physician did not disclose that he had been previously licensed to practice in another state, nor that his license in california had been revoked 31 id 32 id 33 pike v. decatur mem'l hosp., no. 1:04-cv-391-jdt-tab, 2007 u.s. dist lexis 32552, at 1 (s.d. ind. may 1, 2007). 34 id. at 26-27. 35 ind. code § 34-18-3-1 (2012) (providing that if a health care provider fails to "qualify," it loses the protections afforded it under the act). 36 pike, 2007 u.s. dist lexis 32552, at 2. 2013 255 indiana health law review due to a mental illness..37 the physician was credentialed to perform emergency room services, despite previously having his medical license suspended in the state of california,. 38 nes argued that it was not a "qualified provider" as required by the act.3 9 the court responded that nes's contract: [t]o be responsible for all physician emergency room services at decatur makes it more than difficult for it to say it is not a "health care provider" when the statute provides that an agent of a facility authorized by the state to provide health care is a "health care provider."40 once the court determined that nes was considered a "health care provider" under the provisions of the act, it turned to the specific claim of negligent credentialing.41 nes attempted to shift the burden of negligent credentialing to the hospital since nes believed it was "insulated from liability . . . because decatur had ultimate responsibility for issuing hospital privileges and regardless of what information nes may have provided."42 the court found that, at the time the hospital granted credentials to dr. angel, dr. angel had not yet obtained the california license so there was no evidence that decatur knew he had a license in california or that is was revoked. 43 however, the evidence was clear that nes had dr. angel's curriculum vitae, which listed his california license number, and nes had in place a policy of conducting two-year reviews for its physicians. 44 the court ultimately held that nes could be 37 id " id. at 9. 39 id. at 17; see ind. code §§ 34-18-2-24.5 and 34-18-3-2 (2012) (requiring that medical providers and their insurers file certain proofs with the commissioner to become "qualified"). 40 pike, 2007 u.s. dist lexis 32552, at 26 (construing ind. code § 34-182-14(1) (2012)). 41 id. at 28. 42 id 43 id 4 id. at 28-29. 256 vol. 10:1 negligent credentialing as a cause of action held liable for the negligent credentialing claim, but there was not sufficient evidence for summary judgment. 45 this case is essential to the basis of case law for negligent credentialing since it expanded the realm of negligent credentialing liability to third party entities that contract with hospitals. the next case to provide guidance on negligent credentialing in indiana was beswick v. bell, which was decided in december of 2010.46 the court noted that indiana accepted negligent credentialing as a cause of action in the decision of winona but went on to state that the elements needed for a negligent credentialing claim had not been defined in indiana law.4 7 the court looked to ohio and illinois law to determine what elements are needed to satisfy a negligent credentialing cause of action.4 8 in 2009, the ohio supreme court held that "[to prove a negligent-credentialing claim, a plaintiff injured by the negligence of a staff doctor must show that but for the lack of care in the selection or retention of the doctor, the doctor would not have been granted staff privileges, and the plaintiff would not have been injured."49 the indiana court of appeals read this as: "ohio law contemplates some knowledge on the part of the hospital that would render its credentialing decision negligent."50 the court also looked to a decision rendered by the illinois appellate court, which looked to other federal and state courts on the issue of negligent credentialing.51 the illinois court decided that: "[tlhe elements needed to prove negligent credentialing" were as follows: that "the hospital failed to meet the standard of reasonable care in the selection of the 45 id. at 29-30. 46 beswick v. bell, 940 n.e.2d 338 (ind. ct. app. 2010). 47 id. at 344. 48 id. at 344-45. 49 id. at 345 (citing schelling v. humphrey, 916 n.e.2d 1029, 1033 (ohio 2009)). 50 id 51 id 2013 257 indiana health law review physician it granted medical state privileges to whose treatment provided the basis for the underlying medical mal-practice claim"; and that "while practicing pursuant to negligently granted medical staff privileges, the physician breached the applicable standard of care"; and that "the negligent granting of medical staff privileges was the proximate cause of the plaintiffs injuries."52 after reviewing the other courts' decisions, the indiana court of appeals held that since there were no previous complaints or allegations from patients of negligence against dr. bell and since dr. bell held the appropriate state medical license and board certification for an orthopedic surgeon, there was no evidence that the hospital knew he had deviated from the standard of care, as required by the yaney decision. 53 furthermore, the court held that there was no evidence that but for the lack of care in the selection or retention of dr. bell, he would never had been given staff privileges, as required by schelling.54 this decision is extremely important since it outlines the elements for a negligent credentialing cause of action. however, the decision leaves an ambiguous area of what exactly is required by a hospital to protect itself against negligent credentialing claims. perhaps, more importantly, it leaves the question of how much importance hospitals should place on patient complaints in determining physician retention and how past complaints may affect in their defense of negligent credentialing claim. this decision is also important because the court of appeals looked outside of indiana for guidance on how to handle the issues presented in a negligent credentialing decision. given the precedent of looking to other jurisdictions for guidance in negligent credentialing claims, it would be advantageous to be familiar with how these 52 id. (citing frigo v. silver cross hosp. & med. ctr., 876 n.e.2d 697, 723 (ill. app. ct. 2007)). 5 id. 54 id 258 vol. 10:1 negligent credentialing as a cause of action jurisdictions are deciding negligent credentialing decisions and any new areas of development in this area so as to gain a better understanding of how the indiana court of appeals may address these issues in the future. in december of 2011, the indiana court of appeals once again addressed a claim of negligent credentialing.5 5 the plaintiff filed a medical malpractice claim against the defendant doctor following issues from a bilateral breast reduction.56 the medical review panel issued a unanimous opinion that the doctor failed to meet the standard of care in treating the plaintiff and that the defendant hospital failed to meet the standard of care in granting the doctor privileges.57 however, the trial court granted summary judgment for both defendants because the plaintiff missed deadlines for admitting expert evidence.5 8 on appeal, the indiana court of appeals held that "the trial court properly granted summary judgment to dr. park because martinez failed to rebut the expert testimony that he did not breach the applicable standard of care in preoperatively, surgically, or post-operatively treating martinez." 59 the court then held that the summary judgment on the negligent credentialing claim was also appropriate because the defendant cannot be liable "[wlithout a showing of an underlying breach of the standard of care by [the doctor] proximately causing [plaintiffs] injuries."60 while this case did not exactly create new law for lower courts to implement, it is important in that it reiterated the importance of establishing a medical malpractice claim against a defendant doctor in order to prove a negligent credentialing claim. 5 martinez v. park, 959 n.e.2d 259 (ind. ct. app. 2011). 56 id. at 260. " id. at 266-67. 5 id at 271-72. 60 id at 272. 2013 259 indiana health law review iii. current trends in negligent credentialing from other jurisdictions as noted above, the court in beswick v. belllooked to the court decisions from ohio and illinois for guidance on a negligent credentialing claim because of the lack of indiana cases on the subject. 61 given the importance other jurisdictional decisions can have on the indiana court system, it is imperative to look at trends happening around the country in the area of negligent credentialing that could have an impact on indiana law. a. bifurcation in 2009, the supreme court of ohio handed down a ruling in scheling v. humphrey, which pertained to bifurcation of negligent credentialing claims.62 the plaintiff filed a claim against the surgeon for medical malpractice relating to two heel surgeries and also filed a claim against the hospital for negligently granting staff privileges to the surgeon. 63 the plaintiff subsequently dismissed her claim against the physician after the surgeon filed for bankruptcy and the plaintiff reached a settlement with the bankruptcy trustee. 64 however, the plaintiff continued with her negligent credentialing claim against the hospital.65 prior to the surgeon filing for bankruptcy, the hospital moved to bifurcate the negligent-credentialing claim and the medical malpractice claim against the surgeon, arguing that "the negligent-credentialing claim did not become ripe until the doctor's negligence was determined".66 the trial court granted this motion.67 once the settlement was reached between the plaintiff and the surgeon, the hospital moved for dismissal of the claim arguing that without a finding of negligence, the negligent credentialing claim 61 beswick v. bell, 940 n.e. 2d 338, 344-345 (ind. ct. app. 2010). 62 schelling v. humphrey, 916 n.e.2d 1029, 1031 (ohio 2009). 63 id. 6 id. at 1031-32. 65 id. at 1031. 66 id 67 id. 260 vol. 10: 1 negligent credentialing as a cause of action could not be established. 68 the hospital did not believe the bankruptcy court found negligence in this case nor was the hospital aware that the surgeon had admitted negligence. 69 the supreme court of ohio ultimately held that the plaintiff could continue with the negligent credentialing claim, in the absence of the surgeon, so long as she could prove that his malpractice was a causal element of the claim against the hospital. 70 given the unusual circumstances of the case, the court stated that the impeded plaintiff "should be permitted to prove that [the surgeon] committed medical malpractice and that the alleged malpractice caused the [plaintiffs] injury, as an element of their negligent credentialing claim against the hospital."71 the supreme court of ohio gave further instruction regarding the bifurcation of the claims by stating that the bifurcation of the medical malpractice claim and the negligent credentialing claim would avoid "the problems of jury confusion or prejudice that may result from admitting evidence of prior acts of malpractice in a combined trial on both claims." 7 2 evidence of prior malpractice by the surgeon would lend credibility to the negligent credentialing claim, but would provide for unfair prejudice in the jury determination of whether the doctor committed malpractice. 73 additionally, the court reasoned that bifurcation was appropriate because if the medical malpractice claim against the doctor did not prevail, the negligent credentialing claim could be dismissed.74 the court stated that "[ilf the fact-finder determines that negligence of the doctor is not the cause of the plaintiffs injury, then a hospital's grant of staff privileges to a doctor is not the cause of the plaintiffs injuries."75 the kentucky court of appeals has also ruled on the 6 id. at 1032. 69 id. 70 id. at 1036-37. ' id. at 1036. 72 id. 73 id 74 id. 75 id. 2013 261 indiana health law review issue of bifurcation in patterson v. marshall.76 in that case, the court actually affirmed trifurcation of the claims and ordered that the trial proceed in three separate stages before the same jury with the medical negligence claim against the physician first, followed by the hospital's statute of limitations defense if the physician was found guilty, and then ending with the negligent credentialing claim if the defense was not sustained.77 in addition to the proposed plan, the trial court excluded all matters relating to the physician's employment history during the phase pertaining to the physician's medical negligence claim and also denied the plaintiffs motion to compel the hospital to produce the physician's credentialing files and peer review files.7 8 the appellate court held that the trial court had not abused its discretion in regard to the challenged trial plan.7 9 in regard to a challenge to the hospital's participation in the first trial state, the appellate court reasoned that "to prevent [the hospital] from introducing evidence of [defendant's] compliance with the standard of care would have prevented [the hospital] from defending itself against the negligent credentialing claim under the procedure utilized by the trial court."80 in regards to the challenge of the trial court excluding evidence of the physician's employment and peer review, the court reasoned that the physician's prior loss of privileges held no bearing on the standard of care he provided to the plaintiff, and allowance of this evidence would only confuse the two issues of medical negligence and negligent credentialing in this case.81 while allowing for the bifurcation of the claims, the kentucky court of appeals did not formally recognize negligent credentialing as a cause of action in this claim. 82 in june 2010, the kentucky court of appeals revisited the issue of bifurcating claims in negligent 76 patterson v. marshall, no. 2008-ca-000157, 2009 wl 2341448, at 1 (ky. ct. app. july 31, 2009). n id at 2. 78 id 79id 80 id at 3. 1' id 82 id at 2. 262 vol. 10:1 negligent credentialing as a cause of action credentialing cases in estate of burton v. trover clinic foundation, inc.83 in delivering the opinion, the court began by first recognizing negligent credentialing as a valid tort in the state of kentucky. 84 in this case, the defendant doctor and the defendant hospital joined together and filed a motion, granted by the trial court, to bifurcate the case into two phases which would include the medical negligence issues first, followed by all other issues in the case including the claim of negligent credentialing.85 the court stated that in deter-mining bifurcation of these claims, trial court should "consider potential prejudice to the parties, potential confusion to the jury, and the relative convenience and economy which would result."86 the court then held that bifurcation in this instance was not an abuse of discretion by the trial court. the plaintiff argued that bifurcation of the trials was a reversible error on the grounds that bifurcation was in violation of a state statute requiring that a jury consider all issues concurrently and bifurcation deprived the plaintiff of his constitutional right to conduct a full voir dire.87 the relevant statute in this appeal is krs § 411.186 which states that "[iln any civil action where claims for punitive damages are included, the jury . . . shall determine concurrently with all other issues presented, whether punitive damages may be assessed."88 the court held that the statute was not violated because the trial court only bifurcated the claims between the defendants, but did not bifurcate the damages claims in relation to each individual defendant.* 89 in relation to the voir dire argument, the plaintiff only submitted voir dire questions on the first phase of the trial for the medical negligence claim. 90 the court held that 83 estate of burton v. trover clinic found., inc., no. 2009-ca-001595-mr, 2010 wl 6816338, at 2 (ky. ct. app. june 10, 2011). 84 id. at 2. 85 id at 1. 86 id at 3. 87 id at 2. 88 ky. rev. stat. ann. § 411.186 (west 2012). 89 estate ofburton, 2010 wl 6816338, at 3. 90 id. 2013 263 indiana health law review the plaintiff should have been allowed to conduct a full voir dire in the initial phase that concerned both phases of the bifurcated trial.91 however, the court went on to note that there was no reversible error because the jury did not find the defendant doctor negligent in the first phase of the trial, so the second portion of the trial was never conducted. 92 the indiana courts should adopt bifurcation of medical malpractice claims and negligent credentialing claims. the bifurcation of these claims saves hospitals the unnecessary expense of defending a claim that may be dismissed prior to adjudication. in december 2011, the american medical association released a medical liability reform report indicating that the average cost of defending a physician in a medical liability claim in 2010 was $47,158.93 further, the report noted that in 2010, 63.7% of closed claims against physicians were dropped, withdrawn, or dis-missed without any payment, and that each of these claims costs an average of $26,851 to defend. 94 hospitals and the physicians are both paying these amounts to defend medical liability claims that involve negligent credentialing complaints. it may even be advantageous to allow bifurcation of not only the trial, but also the discovery phases of these claims, limiting the initial phase to the issues involved in the underlying medical negligence claim against the physician. bifurcating the discovery phase would, in effect, focus on determining the underlying issue of whether the physician was negligent.9 5 moreover, it would "lessen credentialing discovery expense by postponing the need to depose those involved in the credentialing process, witnesses testifying on the physician's alleged defects and experts."96 since over half of medical malpractice claims against physicians are 91 id 92 id 93 morgan lewis, jr., medical malpractice costs continue to climb, mod. med. (jan. 11, 2012), http://www.modernmedicine.com/modernmedicine/article/ articledetail.jsp?id=755739 (last visited sept. 27, 2012). 94 id 9 thomas j. hurney, jr. et al., defending negligent credentialing cases, for the def. 44, 51 (july 2010), available at http://www.moser.com/firm-newsand-events/ftd1 007-hurneystiegerwillmanpozzo.pdf. 96 id. 264 vol. 10:1 negligent credentialing as a cause of action dropped, it would be advantageous to bifurcate the claims and, at least, save the hospital the expenses of defending a claim that can only be adjudicated on after the physician has been found negligent.9 7 in instances of bifurcation, the court should permit the hospital to participate in all phases of the trial since the hospital is a defendant in an underlying claim.9 8 bifurcation also allows for protection against jury bias against a physician defending himself in a medical malpractice suit. moreover, bifurcating claims is in conformity with the federal rules of evidence. federal rule of evidence 404(b) provides that "le]vidence of a crime, wrong, or other act is not admissible to prove a person's character in order to show that on a particular occasion the person acted in accordance with the character."99 by following the holding and guidance in estate of burton v. trover clinic foundation, inc.,100 the indiana courts would give guidance to the lower courts of what issues to consider when bifurcation is presented. further, this decision helps to direct how to deal with voir dire in instances of bifurcating a negligent credentialing claim and what needs to be included in the initial voir dire process. b. qualified immunity some jurisdictions have looked to state statutes to give qualified immunity from negligent credentialing so long as the hospital is compliant with credentialing procedures. in huntsman v. aultman hospital, the ohio court of appeals provided that the defendant hospital was not subject to 97 dwight golann, dropped medical malpractice claims: their surprising frequency, apparent causes, and potential remedies, soc. sci. res. network (july 19, 2011), http://ssrn.com/abstract-1896181 (last visited sept. 27, 2012). 98 see patterson v. marshall, no. 2008-ca-000157, 2009 wl 2341448, at 3 (ky. ct. app. july 31, 2009) (holding that "to prevent [defendant hospital] from introducing evidence of [the doctor's] compliance with the standard of care would have prevented [defendant hospital] from defending itself against the negligent credentialing claim under the procedure utilized by the trial court"). 99 fed. r. evid. 404(b). 100 estate of burton v. trover clinic found., inc., no. 2009-ca-001595-mr, 2010 wl 6816338 (ky. ct. app. june 10, 2011). 2013 265 indiana health law review liability for alleged negligent re-credentialing since there was a state statute that granted the hospital qualified immunity from liability based on the hospital's compliance with credentialing proce-dures. 101 here, a deceased patient's estate brought a negligent credentialing claim against the hospital subsequent to the patient passing away one day after a hernia repair procedure. 102 the trial court granted summary judgment to the defendant hospital concluding that "r.c. 2305.25 does not allow for a cause of action for negli-gent credentialing against a hospital where a credentialing process was in place."103 the trial court also stated that "a hospital cannot be held liable for 'sloppy' credentialing, so long as the proper credentialing process was followed."104 the relevant statute at issue in this case was r.c. 2305.25, which stated, in part, that "[no hospital . . . shall be liable in damages to any perform for any acts, omissions, decisions, or other conduct within the scope of the committee."105 committee was statutorily defined as: "a board or committee of a hospital . .. of which the hospital. . . is a member reviewing professional qualifications or activities of the medical staff as the hospital . . . or applicants for admission."10 6 since there were regulated, specific credentialing procedures in place at the time of credentialing, and the procedures were followed by the hospital in the recredentialing process of the physician in this instance, the hospital was shielded from a negligent credentialing claim.107 the court did further provide that "r.c. 2305.25 does not provide blanket immunity to a hospital for negligence in granting and/or continuing staff privileges of 101 huntsman v. aultman hosp., no. 2010ca00211, 2011 wl 884107, at 5 (ohio ct. app. mar. 14, 2011). 102 id. at 2. 103 id 04 id. at 5. los ohio rev. code ann. § 2305.25 (west 2012). 106 huntsman, 2011 wl 884107, at 3 (citing ohio rev. code ann. § 2305.25 (west 2012)). 107 id. 266 vol. 10:1 negligent credentialing as a cause of action an incompetent physician." 0 8 codifying regulations for credentialing procedures in indiana would place hospitals on notice as to what is specifically required in the credentialing process to avoid a negligent credentialing claim. also, not affording blanket immunity to the hospital maintains the ideal of hospital responsibility in regard to ensuring patient safety through its actions, but does afford the hospital protection against liability for acting in accordance with standards ensuring patient safety. it is important to note that the ohio statute cited in this claim is no longer a statute. ohio has now put in to place r.c. 2305.251, which specifically provides that there is a presumption of no negligence in credentialing and provides immunity for hospitals as long as they follow a laid out process in credentialing physicians.109 c. negligent credentialing and the peer review process one recent trend in negligent credentialing litigation is the determination of whether peer review privilege extends to negligent credentialing claims. in general, the peer review process is "a process by which health care providers evaluate their colleagues' work to determine if it complied with the standard of care by understanding the root cause of why a preventable adverse event occurred."110 this process is generally used in the credentialing process with the governing body of the hospital overseeing the finalized recommendations of the peer review committee.11 ' the peer review committee is involved in reviewing initial applications from medical professionals who do not yet have current membership in the medical facility, reappointments for staff members who are currently privileged or credentialed for the facility, and situations in which a 108 id. 109 ohio rev. code ann. § 2305.251 (west 2012). 10 patricia a. sullivan & jon m. anderson, the health care debate: iflack of tort reform is part of the problem, federalized protection for peer review needs to be part of the solution, 15 roger williams u. l. rev. 41, 45 (2010). "' craig w. dallon, understanding judicial review of hospitals' physician credentialing and peer review decisions, 73 temp. l. rev. 597, 610 (2000). 2013 267 indiana health law review problem is identified with an existing privilege.112 inherent with the peer review process and negligent credentialing is the problem that most states, including indiana, provide immunity to peer review committees in disclosing information.113 indiana code section 34-30-15-1 provides: "(a) all proceedings of a peer review committee are confidential. (b) all communications to a peer review committee shall be privileged communications."114 some defendant hospitals will argue that immunity provided for in peer review statutes precludes negligent credentialing as a cause of action. indeed, invoking the peer review privilege in a negligent credentialing claim could be a crucial move for defendant hospitals since it would protect any documents the peer review committee used .in the credentialing process, thus frustrating the efforts of the plaintiff to obtain evidence through discovery methods.115 a hospital can adopt a medical staff bylaw specification that defines "peer review" or "peer review committee" in an extensive way that is still consistent with the language of the state's peer review statute in an effort to protect even more information under peer review confidentiality provisions.116 most hospitals have their credentialing process outlined in their bylaws and policies. bylaw, policies, procedures, and guidelines are all discoverable since they are available through original sources and are not protected by any peer review privilege.117 thus, if a hospital follows its own policies and bylaws, and they are in accordance with credentialing and peer review statutes, the hospital should not be found to be negligent in the credentialing process. by blocking the discoverability of the actual peer review 112 id. 1 id. at 611. 114 ind. code § 34-30-15-1 (2012). 11s katten muchin rosenman, llp, current issues in negligent credentialing part ii, jdsupra (june 14, 2011), http://www.jdsupra.com/post/ documentviewer.aspx?fid=9c44f04d-7376-4d74-91fd-da9c9288bll4 (last visited sept. 27, 2012). 116 id. 117 charles david creech, the medical review committee privilege: a jurisdictional survey, 67 n.c. l. rev. 179, 229 (1988). 268 vol. 10:1 negligent credentialing as a cause of action process that was used in the credentialing, the hospital has the upper hand on the claim. since every state has its own peer review statute, it is important to examine how different states have interpreted the role of these statutes in negligent credentialing claims. 1. minnesota's interpretation of the peer review privilege in neghgent credentialing claims. larson v. wasemiller is a landmark case, in which the minnesota supreme court recognized, for the first time, that the tort of negligent credentialing of a physician by a hospital exists under the common law and is reinforced, not precluded, by minnesota's peer review statute." 8 larson is important to review since it reasons through several portions of minnesota's peer review statute, and the statute is very similar to the indiana statute on peer review.119 the court in larson looked at several issues with the minnesota peer review statute as it pertained to negligent credentialing. first, the court looked to whether the statute created a cause of action for negligent credentialing. the statute provides: no review organization and no person shall be liable for damages . .. when the person acts in the reasonable belief that the action or recommendation is warranted by facts known to the person or the review organization after reasonable efforts to ascertain the facts upon which the review organization's action or recommendation is made.120 the court found that the "language of this statute implies that a review organization shall be liable for granting privileges where the grant is not reasonably based on the facts that were known or that could have been known 118 larson v. wasemiller, 738 n.w.2d 300 (minn. 2007). "9 id. at 303-04 (discussing minnesota's peer review statute). 120 minn. stat. § 145.63 (2012). 2013 269 indiana health law review by reasonable efforts."121 the court declared that while the statute did not affirmatively declare a negligent credentialing cause of action, it indicated the existence of a cause of action.122 next, the court looked to whether negligent credentialing as a cause of action would conflict with the section of minnesota's peer review statute that provided a provision for confidentiality.12 3 the confidentiality provision states, in part: [d]ata and information acquired by a review organization, in the exercise of its duties and functions . . . shall not be subject to subpoena or discovery . .. the proceedings and records of a review organization shall not be subject to discovery or introduction into evidence in any civil action against a professional arising out of the matter or matters which are the subject of consideration by the review organization.12 4 the defendant hospital argued that the statute prohibited it from disclosing information the credentialing committee relied on in making its decision.125 therefore, the statute precluded a claim of negligent credentialing since the issue in negligent credentialing claims is whether the hospital was negligent in credentialing the physician on the basis of what he actually knew at the time of the decision.126 the court responded that this interpretation was too narrow since negligence is decided on "what was actually known or what should have been known at the time of the credentialing decision."127 121 larson, 738 n.w.2d at 304. 122 id 123 id. at 309-10. 124 minn. stat. § 145.64 (2012). 125 larson, 738 n.w.2d at 309. 126 id. 127 id. at 310. see also diaz v. feil, 881 p.2d 745, 750 (n.m. ct. app. 1994) (should have known); corleto v. shore mem'l hosp., 350 a.2d 534, 538 (n.j. super. ct. app. div. 1975) (had reason to know); and albain v. flower hosp., 553 n.e.2d 1038, 1046 (ohio 1990) (had reason to know). 270 vol. 10:1 negligent credentialing as a cause of action there is a provision of the statute indicating that information available from the original source is not immune from discovery or use in civil actions. 128 the court determined that while the statute prevents hospitals from disclosing specific information used by the credentialing committee, it does not prevent hospitals from introducing the same information, so long as it could be obtained from the original sources. 129 the court acknowledged that this does, in fact, further burden the plaintiff since the plaintiff has no way of discovering what exact information was used by the hospital in the credentialing process.130 however, it does provide the plaintiff with the cause of action and a chance to demonstrate what the hospital should have known at the time of the credentialing process. the court then looked to whether the immunity from the liability portion of the minnesota peer review statute precluded negligent credentialing claims. the court reasoned that while the statute limited liability of hospitals and credentialing committees, there was no indication of intent to immunize hospitals from liability or to nullify a common law claim for negligent credentialing.131 the court further noted that "[ilf the legislature had intended to foreclose the possibility of a cause of action for negligent credentialing, it would not have addressed the standard of care applicable to such an action."132 larson reconciled the disparities that can exist between peer review statutes and negligent credentialing claims. however, one result of this decision is that "[alttorneys and trial court judges must walk a fine line between allowing the case to proceed within the parameters established by the minnesota supreme court while maintaining the strict confidentiality established by the minnesota legislature."'3 3 while this was a minnesota case, the ramifications of the 128 minn. stat. § 145.63 (2012). 129 larson, 738 n.w.2d at 310. 130 id 131 id. at 311. 132 id. 133 mark r. whitmore, a survivor's guide to larson v. wasemiller: an aid to eliminating reversible error in managing negligent credentialing claims under minnesota law, 1 wm. mitchell j.l. & prac. 2 (2008). 2013 271 indiana health law review decision could reach to other jurisdictions since every state has similar peer review statutes. since negligent credentialing as a cause of action is still being developed in some areas, courts may look to this decision to develop their areas of common law. this decision is important for indiana to adopt since the statutes at issue in the case are similar to indiana's statutes. the courts need to recognize the potential issues presented through the peer review statutes and provide guidance in how these statutes will be followed in case determinations. 2. texas's interpretation of the peer review privilege in negligent credentialing claims another example of peer review protection in negligent credentialing is found in the texas medical malpractice act. 134 through the texas medical malpractice act, health care providers are given immunity from determinations made in the course of peer review, so long as those decisions were made without malice. 135 further complicating the process of proving negligent credentialing through the texas medical malpractice act's immunity provision of peer review committees is that the initial credentialing information is not discoverable.136 the court in st. luke's episcopal hospital v. agbor determined that malice, within the context of negligent credentialing, involved a showing not that the hospital acted with malice toward the patient but that it acted with malice, in general.137 in determining what behavior constituted malice, the court looked to the civil practices and remedies code and held that to support a negligent credentialing claim, a showing of malice requires demonstrating that: 134 tex. occ. code ann. § 160.010 (west 2012). 3 id. 136 see brownwood reg'1 hosp. v. eleventh cir. ct. app., 927 s.w.2d 24 (tex. 1996); irving health care sys. v. brooks, 927 s.w.2d 12 (tex. 1996). 13n see st. luke's episcopal hosp. v. agbor, 952 s.w.2d 503, 506 (tex. 1997). 272 vol. 10:1 negligent credentialing as a cause of action (a) a specific intent by the defendant to cause substantial injury to the claimant; or (b) an act or omission: (i) which when viewed objectively from the standpoint of the actor at the time of its occurrence involves an extreme degree of risk, considering the probability and magnitude of the potential harm to others; and (ii) of which the actor has actual, subjective awareness of the risk involved, but nevertheless proceeds with conscious indifference to the rights, safety, or welfare of others. 138 in 2005, the texas supreme court revisited negligent credentialing through romero v. kph consolidation, inc. 39 the court stated that since peer review communications and proceedings were generally confidential, "a plaintiff must prove that a hospital acted maliciously without access to evidence of what happened, or did not happen, in the credentialing process." 140 in this case, the plaintiff underwent an elective back surgery during which he lost a significant amount of blood before dr. baker, the treating surgeon, or anyone else noticed, and "in the 45 minutes it took to prepare a transfusion, he lost almost all of the blood in his body."141 as a result of the blood loss, the plaintiff went into cardiac arrest and suffered severe, permanent brain damage, leaving him "profoundly disabled and unable to care for himself."142 the plaintiff brought a claim for negligent credentialing of dr. baker. despite not having access to the peer review committee records involved in the credentialing process, the plaintiff presented evidence that at the time of credentialing, the hospital had access to information involving dr. baker's involvement in ten malpractice 11 id. at 507. 139 romero v. consol., inc., 166 s.w.3d 212 (tex. 2005). 140 id. at 215. 141 id. at 218. 142 id 2013 273 indiana health law review actions from 1988 to 1993, including one action for operating on the wrong hip of a patient.143 the plaintiff also presented evidence that the peer review committee had information pertaining to dr. baker's prescription drug abuse.144 in light of this evidence, the texas supreme court accepted the court of appeals' assumption that the plaintiff established an objective showing of malice, as required by the statute, since "a physician engaged in drug abuse presents an extreme risk to patients."145 the supreme court also accepted the court of appeals' assumption that the plaintiff established the first prong in the subjective component of malice by showing that the hospital "had actual, subjective awareness of the risk posed by baker's drug abuse, at least at one point in time."146 however, despite all of this, the court concluded that a showing of malice as an element of a negligent credentialing claim required a higher burden of proof at the trial level and a higher standard of review at the appellate level.147 at trial, the plaintiff must prove malice by clear and convincing evidence, and on appeal the court must determine based on the evidence at trial that a reasonable trier of fact could have formed a firm belief or conviction that the reviewing entity acted with malice in credentialing the doctor.148 the texas supreme court may have decided the case differently if the plaintiff had offered testimony that columbia would have suspended dr. baker if it knew of the drug problems, the lawsuits, and the suspension.149 the texas standard of proof in a negligent credentialing claim, in light of its peer review privilege, is almost impossible to meet. as indicated above, despite alarming evidence presented by the plaintiff in romero, the burden of proof of "firm belief or conviction" is almost impossible to 143 id. at 216-17. 44 id. at 216-17. 145 id. at 221. 146 id. 147 id. at 220-21. 148 id. at 221. 149 casey l. moore, note, "in the wake of rose" and "life after romero the viability of a cause of action for negligent credentialing in texas in light of recent texas supreme court decisions, 58 baylor l. rev. 549, 576 (2006). vol. 10:1274 negligent credentialing as a cause of action prove without access to the peer review committees' records. by adopting this type of standard in relation to protecting the peer review committee and their actions, indiana courts would essentially negate the option of negligent credentialing as a cause of action. while the integrity of the peer review committee needs to be afforded protection, that protection must be weighed with the safety of patients and allowing patients an appropriate remedy when that safety has been compromised. 3. iowa ' interpretation of the peer review privilege in negligent credentialing claims in december of 2011, the iowa supreme court ruled on a negligent credentialing case involving the peer review privilege relating to a doctor's credentialing file.150 the plaintiff filed a medical malpractice suit, which included a negligent credentialing claim against the hospital, after he suffered complications from two back surgeries performed in 2000.151 specifically, the plaintiff alleged that the hospital failed to properly investigate the doctor's qualifications, negligently extended surgical privileges to the doctor, and allowed the doctor to continue to perform surgeries after the hospital had reason to know that questions had been raised concerning the surgeries and procedures that the doctor was performing.152 during the course of the case, the plaintiff served a request for production for the complete copy of the doctor's credential file.153 the hospital objected to the request since the credential file was subject to the peer review privilege laid out in iowa code § 147.135.154 despite this, the trial judge entered an order compelling discovery and the hospital produced almost the entire contents of the doctor's credentialing file.155 the case went to trial and the jury 'so cawthorn v. catholic health initiatives iowa corp., 806 n.w. 2d 282 (iowa 2011). 11 id. at 283. 152 id. 153 id 154 id. at 284. 1ss id. 2013 275 indiana health law review found in favor of the plaintiff, and both parties appealed on different grounds.15 6 based on these appeals the supreme court remanded the case for a new trial.157 after the case was remanded but prior to the new trial taking place, the iowa court of appeals handed down the decision in day v. finley hospital, where the court held that the contents of a hospital's credentialing file fell within the scope of the iowa code § 147.135 peer review protection to the extent that those documents were in the custody of a peer review committee.158 at that time, the defendant hospital filed for summary judgment arguing that the new ruling barred production of the credentialing file and without these documents the plaintiff did not have sufficient evidence to prove a prima facie case.159 the trial court ruled that the defendant was not barred from asserting the peer review privilege, even though the documents had been submitted previously, since the new ruling was an "intervening change or clarification of the law."160 the case was appealed to the iowa supreme court. the iowa supreme court looked to the peer review statute and determined that the statute set forth three restrictions: (1) peer review records are "privileged and confidential"; (2) peer review records are "not subject to discovery, subpoena, or other means of legal compulsion"; and (3) peer review records are "not admissible in evidence."16 the court then held that this privilege could not be voluntarily waived by a hospital, and as a result, the hospital was able to claim the privilege even though it had previously submitted the credentialing file.162 this case is important since the hospital was able to assert the peer review privilege after it had submitted the credentialing file for review. it would seem that most hospitals would be given adequate legal advice to bar discovery of these documents in the first place, but this rule 156 id 157 id. at 283. 158 day v. finley hosp., 769 n.w.2d 898, 902 (iowa ct. app. 2009). 159 cawthorn, 806 n.w. 2d at 285. 10 id. at 283. 161 id. at 289 (quoting iowa code § 147.135 (2009)). 162 id. at 291. 276 vol. 10:1 negligent credentialing as a cause of action could add an additional layer of protection against hospitals who fail to assert the privilege. this ruling essentially further frustrates a plaintiffs attempts to access credentialing documents to establish a prima facie case for negligent credentialing. 4. missouri's interpretation of the peer review privilege in negligent credentialing claims in december of 2010, the missouri court of appeals ruled on state ex rel. kirksville missouri hospital company, llc v. jaynes, a negligent credentialing case on whether the peer review privilege protected from discovery documents relating to credentialing of a surgeon.163 in this case a doctor, dr. john bailey, was given temporary privileges to practice back surgery at the defendant hospital in mid-1997. 164 however, at the time the privileges were granted, there was a question as to whether the doctor had actually completed training with the columbia spine fellowship.16 5 the hospital's director of surgery gave a recommendation to the hospitals executive committee which advised having an independent, fellowship trained, spine surgeon review the doctor's first twenty-five spinal instrumentation cases.16 6 subsequent to approval of this recommendation, dr. john flood, the independent, fellowship trained spine surgeon chosen by the executive committee, prepared a written report on his review of the surgeries and submitted this report to the hospital. 6 7 in 2004, the plaintiff filed a lawsuit against dr. bailey alleging negligent treatment and performance of surgery, along with a claim that the hospital was negligent in granting dr. bailey privileges. 168 the plaintiff learned of the report by dr. flood and obtained dr. flood's deposition as a 163 state ex rel. kirksville missouri hosp. co. llc v. jaynes, 328 s.w.3d 418 (mo. ct. app. 2010). '6 id. at 420. 165 id. 166 id. 167 id. 168 id. 2013 277 indiana health law review result. 169 the hospital filed objections claiming that dr. flood's deposition was barred by the peer review privilege in missouri's peer review committee statute. 170 in response to the objections, the plaintiff filed a motion for enforcement of discovery, which was granted in part by the trial court.171 prior to the second deposition, the plaintiff filed a motion for enforcement of discovery or in the alternative, an incamera review, pertaining to documents that were alleged to be part of the report dr. flood had prepared for the hospital and had been identified on a privileged log prepared by the defendant hospital.172 a special discovery master examined the documents and decided that the applicable peer review statute offered no protection to the documents in question.173 the court of appeals ordered that the documents be produced in order to be reviewed on appeal. the court of appeals first reviewed the plain language of the statute which stated that an exception to the privilege was "information otherwise discoverable or admissible from original sources will not be immune from discovery merely because it was presented during proceedings before a peer review committee." 174 the court also reviewed the second exception which included "any person appearing before such a committee, cannot be prevented from testifying about matters within their personal knowledge, though they cannot testify about the proceedings of a committee, including about any testimony they may have provided to a committee."175 upon review of the materials submitted by both parties, the court found that a portion of dr. flood's original report, which included his concerns about seven of the twenty patient charts which he had reviewed, was already in the plaintiffs possession and that the motion to enforce only included portions of the report that plaintiff did not already 169 id 170 id 172 id at 420-21. 173 id 174 id at 422 (citing mo. ann. stat. § 537.035.4 (west 2012)). 175 id 278 vol. 10:1 negligent credentialing as a cause of action have in possession.176 the defendant hospital failed to note this in its petition for writ of prohibition; and the court then determined that the hospital was "not entitled to a permanent writ of prohibition to protect itself from an alleged harm that has already occurred."1 77 in determining whether the rest of the report was protected by the privilege, the court looked to a previous case stating that "[credentials committee findings and deliberations are not exempt from discovery, therefore, unless they specifically concern the health care provided a patient."178 the court then held that the report was not a "peer review committee report", as it did "not fall into the plain and ordinary meaning" of the categories listed in the statute. 179 instead, the report reflected "the knowledge and/or opinions held by an outside source," since dr. flood was a private, outside physician hired by the executive committee of the hospital to review dr. bailey's files.180 the court reasoned that since dr. flood's activities were not sufficient for him to be characterized as a "peer review committee" as required by missouri statute § 537.035, then dr. flood's report could not be characterized as a "peer review com-mittee report."181 additionally, the court held that the report was not protected by the peer review privilege because dr. bailey had already been granted privileges and the purpose of the report was to address the problem that he was granted privileges despite evidence that he had not completed a fellowship program in spine surgery. 182 further, the letter to dr. flood indicated that the hospital wanted to use the report "to defend itself in later lawsuits."183 due to this evidence, the court held that the hospital could not go back on its original stated purpose of the report and claim it was obtained for credentialing 176 id. at 423. 17 id. at 424. 178 id. 179 id. at 425. 1so id. 181 id. 182 id. at 426. 183 id. 2013 279 indiana health law review matters subsequent to seeing the contents of the report.184 the court further held that dr. flood was never in attendance of a peer review committee proceeding; therefore the information in his report could not be protected under the statute.185 further, the court held that the minutes from the actual executive committee peer review meetings discussing the report were not protected because they did not contain information concerning the health care provided to a patient as required by the statute. 8 6 the missouri court's decision to allow consideration of information that the plaintiff already had access to protects the rights of patients and keeps hospitals accountable for negligently credentialing physicians. the missouri case protects peer review committee information as it was meant to be protected, by providing immunity for the committee members and allowing open discussion among physicians' peers in determining disciplinary outcomes without worry of future litigation brought by the individual physician. 87 . however, it also provides an avenue for plaintiffs in a negligent credentialing claim to obtain information that is essential in establishing a prima facie case of negligent credentialing. this case also sets out common law for how to interpret a third party expert opinion that a hospital might use in making credentialing or disciplinary decisions. in interpreting the indiana peer review privilege statute,188 indiana courts should adopt the missouri interpretation of the privilege and permit discovery of any information prepared by an outsider for review by the committee. this would allow for protection of the peer review committee, as intended by the statute, but still afford plaintiffs the opportunity to obtain and use information they may already have or information that is readily available, and which could be used to establish a prima facie case. hospitals would still be protected because 184 id. 1 id at 427-28. 186 id 187 alissa marie bassler, federal law should keep pace with states and recognize a medical peer review privilege, 39 idaho l. rev. 689, 690 (2003). 188 ind. code § 34-30-15-1 (2012). 280 vol. 10:1 negligent credentialing as a cause of action they could hire an inside expert to perform reports or present the information to the peer review committee. under this approach, the statute would also protect the expert. d. statutorylmmunity one recent trend, within the last two years, in negligent credentialing is for state legislatures to provide statutory immunity for hospitals against claims of negligent credentialing. in 2011, at least two states, ohio and utah, passed legislation that provides hospitals with immunity against negligent credentialing claims. each state went about the immunity provision in entirely different ways. 1. utah's negligent credentialing statute in 2010, the utah supreme court decided a case, archuleta v. st. mark's hospital, which ruled that negligent credentialing was a valid cause of action. 189 in this case, the defendant hospital argued that utah code ann. § 58-13-5(7) barred a cause of action for negligent credentialing.190 the language of utah code ann. § 58-13-5(7) states: an individual who is a member of a hospital administration, board, committee, department, medical staff, or professional organization of health care providers is, and any hospital, other health care entity, or professional organization conducting or sponsoring the review, immune from liability arising from participation in a review of a health care provider's professional ethics, medical competence, moral turpitude, or substance abuse.' 9 ' the supreme court of utah held that the plain language of the statute is clear and that "read as a whole and in 189 id. 190 id. at 1046. 191 utah code ann. § 58-13-5(7) (west 2012). 2013 281 indiana health law review harmony with related provisions and chapters, it shows that the legislature did not intend to immunize hospitals from negligent credentialing claims brought by patients."192 the court further reasoned that "the immunity contemplated under the statue operates between a doctor whose credentials are under review and the suppliers of information and decision makers; it does not contemplate immunity between a patient and a hospital."193 senate bill 150 of the 2011 utah legislative general session was then proposed as an attempt to overrule the utah supreme court decision and to provide hospitals with blanket immunity from negligent credentialing claims, no matter the specific circumstances to the case.194 utah passed utah code ann. 1953 § 78b-3-425 in 2011, which provides that "[ilt is the policy of this state that the question of negligent credentialing, as applied to health care providers in malpractice suits, is not recognized as a cause of action."19 2. ohio's negligent gredentialing statute ohio passed ohio rev. code ann. § 2305.251 in 2011.196 the ohio statute is much more expansive than the version passed by utah. ohio rev. code ann. § 2305.251 expands immunity for the peer review privilege without providing full blanket immunity against negligent credentialing. section (b)(1) of the statute provides that a hospital is to be presumed to not be negligent in the credentialing of an individual who has, or has applied for, staff membership or professional privileges at the hospital, if the hospital proves by a preponderance of the evidence that, at the time of the alleged negligent credentialing of the individual, the hospital, health insuring corporation, or sickness and accident insurer was accredited by one of the following: the joint commission on accreditation of healthcare 192 archuleta, 238 p.3d at 1046. 193 id. at 1047. 194 negligent credentialing, s.b. 150, gen. sess. (ut 2011). 195 utah code ann. § 78b-3-425 (west 2012). 196 ohio rev. code ann. § 2305.251 (west 2012). 282 vol. 10:1 negligent credentialing as a cause of action organizations; the american osteopathic association; the national committee for quality assurance; or the utilization review accreditation commission.197 section (b)(2) of the statute provides that the presumption that the hospital is not negligent in credentialing can only be rebutted by a preponderance of the evidence in any of the four following areas: (a) the credentialing and review requirements of the accrediting organization did not apply to the hospital . . . or the type of professional care that is the basis of the claim against the hospital. (b) the hospital .. . failed to comply with all material credentialing and review requirements of the accrediting organization that applied to the individual. (c) the hospital . . . through its medical staff executive committee or its governing body and sufficiently in advance to take appropriate action, knew that a previously competent individual had developed a pattern of incompetence or otherwise inappropriate 'behavior, either of which indicated that the individual's staff membership, professional privileges, or participation as a provider should have been limited or terminated prior to the individual's provision of professional care to the plaintiff. (d) the hospital . . . through its medical staff executive committee or its governing body and sufficiently in advance to take appropriate action, knew that a previously competent individual would provide fraudulent medical treatment but failed to limit or terminate the individual's staff membership, professional privileges, or participation as a provider prior to the individual's provision of professional 197 id. 2013 283 indiana health law review care to the plaintiff. 198 the ohio statute is effective in putting hospitals on notice because it gives hospitals clear guidance as to what actions they can take to protect themselves from negligent credentialing claims, but also preserves the right of an individual plaintiff to recover damages when there has been a clear negligence issue committed on the part of the hospital. adopting a statute similar to the utah statute would deprive individuals, who have been harmed, from collecting damages when the hospital has been negligent in its credentialing process. it would also protect the negligent behavior of hospitals and while failing to provide any incentive for hospitals to adopt thorough credentialing process. instead, the utah statute leaves the patient responsible for verifying the competency of a medical professional.19 9 adopting a statute similar to the ohio statute would be beneficial for indiana. a clear, detailed statute would give hospitals notice as to what exactly is required of them in the credentialing process. it would also solve the issue presented by the court decision in beswick which left many questions for defendant hospitals in how to protect themselves against negligent credentialing claims. further, a statute similar to the ohio statute would preserve the right of harmed individuals to collect damages for injuries that could have been avoided if not for the negligent behavior of the hospital. iv. negligent credentialing and the affordable health care act on july 1, 2011, the value-based purchasing act 20 0 went into effect. the value based purchasing act is an 198 id '9 utah senate bill 150 threatens negligent credentialing as a valid cause of action; credentialing & peer rev. legal insider, april 2011, at 4, available at http://user.xmission.com/~kirton/images/news-articles/credentialing wride. 200 42 c.f.r. § 480 (2012). 284 vol. 10:1 negligent credentialing as a cause of action attempt of health care reform to move health care toward a pay-for-performance model. 201 through this act, the department of health and human services (hhs), collects quality data from hospitals, compiles the data, and then rewards hospitals for meeting certain performance measures in quality and efficiency. 202 this act calls for some disclosure of performance information. 203 one purpose of disclosing this information is that "reducing errors through improved medical practices and effectuating penalties against poorly performing physicians may benefit the overall performance of the medical malpractice insurance system."204 currently, states have primary authority to administer medical licensing and to standardize medical practice. unfortunately, this leaves the issue that each state has its own method of tracking physicians and there is a lack of uniformity among the states. 205 the patient protection and affordable care act (ppaca) helps to unify the reporting and regulating requirements among the states and allows for better tracking and recording of adverse events and physicians. 206 there are several ways that this requirement could impact negligent credentialing in indiana claims. first, under the value-based purchasing act, the hospitals are required to disclose each physician's performance with public or private review organizations. 20 7 this data is then compared to other providers' performance levels. 208 this 201 charles fiegl, medicare pay-for-performance plan criticized over early launch, american medical news, september 19, 2011, http://www.amaassn.org/amednews/2011/09/19/gvl 10919.htm. 202 hospital value-based purchasing program, icn 907664, nov. 2011, available at http://www.cms.gov/ outreach-and-education/medicare-learningnetwork-mln/mlnproducts/downloads/hospital vbpurchasingfactsheet_ icn907664.pdf. 203 id. 204 bernadette fernandez, baird webel, vivian s. chu, medical malpractice insurance and health reform, congressional research service, april 15, 2010, at 4. 205 id. 206 see barry r. furrow, regulating patient safety: the patient protection and a ordable care act, 159 u. pa. l. rev. 1727 (2011). 2 42 c.f.r. § 480. 208 id. 2013 285 indiana health law review public information could be used as direct evidence against a hospital showing that it had knowledge that it should not have credentialed or re-credentialed a particular physician.209 as mentioned above, peer review privilege protects the hospital from having to disclose what exact information was used in the credentialing process. however, this rule would make performance information available to the public making it easier for a plaintiff to obtain this information during discovery and to build a claim on what the hospital shouldhave known. second, the rule requires external reporting of an adverse event.210 it has been proposed that "external reporting of an adverse event that is separately the focus of a malpractice or other claim could result in the waiver of evidentiary privilege against discovery of this information."211 this could significantly affect hospitals in negligent credentialing claims since indiana requires that there be an underlying medical malpractice claim to substantiate a negligent credentialing claim. the waiver of evidentiary privilege could give the plaintiff in these claims an added advantage. unfortunately, the act is so new that it is yet to be seen how the courts will interpret the mandatory reporting requirements in lieu of evidentiary and peer review privilege. it also remains to be seen as to what extent the mandatory reporting information will be made available for use in litigation and adjudication of medical malpractice claims. v. conclusion since 1965, negligent credentialing as a valid cause of action in medical malpractice claims has been slow to be adopted throughout state courts. although indiana adopted negligent credentialing as a valid cause of action in 2000, it 209 stacy l. cook, will pay for performance be worth the price to medical providers? a look at pay for performance and its legal implications for providers, 16 annals health l. 163, 180 (2007). 2 0 42 c.f.r. § 480. 211 anne b. claiborne, julia r. hesse & daniel t. roble, legal impediments to implementing value-based purchasing in healthcare, 35 am. j.l. & med. 442, 468 (2009). 286 vol. 10:1 negligent credentialing as a cause of action has been slow to rule on decisions and the indiana supreme court has yet to hear a case involving this issue on appeal. the lack of rulings and case law on this topic leaves both defendant hospitals and plaintiffs unsure of how to proceed in these claims and what exactly is required to bring this type of claim. indeed, the more recent cases have tended to leave more questions than answers regarding elements and evidence in these claims. as more cases are decided on the topic, the indiana courts should be aware of where other jurisdictions stand on this cause of action since they have historically looked to neighboring jurisdictions for reference in newer areas of law. the issues of bifurcating claims between physicians and hospitals should be addressed to protect the integrity of claims and efficiency of the court process. also, the concern of how the peer review committee protections affect discovery in these claims will need to be clearly laid out in future decisions. the courts and counsel need to be cognizant of recent legislation on negligent credentialing in other states and how it could be implemented in the state of indiana either to override or to protect court decisions. lastly, the recent enactment of the patient protection and affordable care act could have far reaching implications for negligent credentialing actions and the discovery process in these claims. as the act is put into practice, it remains to be seen how the courts will interpret the reporting requirements and their use in medical malpractice adjudication. however the courts and legislature decide to rule out these concerns, the primary issue of balancing patient safety and recourse with hospital and physician responsibility needs to be at the forefront of the decisionmaking process. 2013 287 indiana health law review 2012-2013 editor-in-chief pervin rusi taleyarkhan executive managing editor brock landon easton executive editor jennifer nicole risser executive production editors daniel isaac hageman kyle ryan wood executive notes editor julia suzanne hudson executive articles editor alyssa conley james executive symposium editor james m. inman executive business editor kimberly anne opsahl note development editors cora ann davidson frandy st. louis lindsey stout articles editors john brett curry justin david rumer william c. starr associate editor myriam serrano members christopher michael anderson james blair banister samuel dayton jessica m. dugdale romy naser elswerky charlotte fillenwarth paul k. ho thomas frederick martin charity ann mansfield james timothy nussbaum jacob m. o'brien janice kristina pascuzzi laura bolon sahm nicole marie long sharp megan michelle smith faculty advisors nicholas p. terry (chair) david orentlicher (chair) eleanor d. kinney (adviser emerita) robert a. katz emily michiko morris miriam a. murphy (research liaison) volume 10 indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care 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issue, $15 indiana university robert h. mckinney school of law 2012-2013 administrative officers and faculty administrative officers michael a. mcrobbie, president of the university. ph.d., australian national university. ch arles r. bantz, chancellor, indiana university-purdue university-indianapolis; indiana university executive vice president. b.a., m.a., university of minnesota; ph.d., ohio state university. gary r. roberts, dean and gerald l. bepko professor of'law. b.a., bradley university; j.d., stanford university. antony page, vice dean. professor of law and dean's fellow. b. comm., mcgill university; m.b.a., simon fraser universityj.d., stanford law school. karen e. bravo -iassociate dean jbr international affairs, professor of law, john s. grimes fellow; dean's fellow. b.a., the university of the west indies; j.d., columbia university school of law; ll.m., new york university school of law. gerard n. magliocca, associate dean for research, samuel r. rosen professor of law. b.a., stanford university; j.d., yale law school. james p. nehf, associate dean for graduate studies, cleon h. foust fellow, john s. grimes fellow, and professor of law. b.a., knox college; j.d., university of north carolina law school. jonna kane macdougall, assistant dean for external affairs andalumni relations; adjunct professor of law. b.a., m.a., indiana university; j.d., indiana university robert h. mckinney school of law. johnny d. pryor, assistant dean for student affairs. b.a., wittenberg university; j.d., indiana university maurer school of law. chasity q. thompson, assistant dean for professional development. a.s., b.a., alabama state university; m.b.a., auburn university; j.d., indiana university robert h. mckinney school of law. mark v. wunder, assistant dean for development. b.s., j.d., university of iowa. john r. schaibley, iii, executive director of the center for intellectual property law and innovation and adjunct professor of law. b.a., purdue university; j.d., indiana university maurer school of law. elizabeth allington, director of communications and creative services. b.a., indiana university; m.a., m. phil., new york university. teresa (terri) j. cuellar, director of technology services. b.s., st. bonaventure university, new york. brandt hershman, director ofeducational outreach. purdue university. amanda kamman, director offundraising and development services. b.a., indiana university. patricia k. kinney, director ofadmissions. b.s., purdue university; j.d., indiana university robert h. mckinney school of law. virginia marschand, director of administrative and fiscal affairs. b.s., indiana university-kokomo; m.p.a., indiana university purdue university-indianapolis; j.d., indiana university robert h. mckinney school of law. sonja rice, director ofspecial projects. b.a., purdue university; j.d., indiana university robert h. mckinney school of law. amy k. spears, director ofmajor gifts. b.a., earlham college. lawanda w. ward, director ofpro bono and public interest programs. b.a., murray state university; m.a., illinois state university; m.s., old dominion university; j.d., indiana university robert h. mckinney school of law. jacob j. manaloor, associate director for contracts, grants & fundraising. b.s., indiana university purdue university-indianapolis; j.d., indiana university robert h. mckinney school of law. anthony masseria, associate director for graduate programs. b.a., hanover college; m.s. ed. indiana university. sean southern, associate director, office ofprofessional development. b.a., ball state university; m.a., depaul university; j.d., loyola university chicago school of law. carlota toledo, associate director of student affairs. a.b., university of chicago; j.d., depaul university college of law. susan k. agnew, assistant director of student affairs. clark college. william j. baker, assistant director of technology services. b.s., purdue university. susan bushue-russell, assistant business manager. a.a.s., lakeland college; b.s., eastern illinois university amanda gallaga, assistant director ofrecruitment. b.a., trinity university. noah joseph, assistant director for graduate studies. b.a. miami university; j.d., indiana university maurer school of law. karen h. miller, assistant director for admissions. midway college. lisa schrage, assistant director for donor relations. b.s., marian college. faculty cynthia m. adams, clinical professor oflaw. b.a., kentucky wesleyan college; j.d., indiana university robert h. mckinney school of law. judith ford anspach, professor oflaw and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. cynthia a. baker, clinical professor of law and director, program on law and state government. b.a., j.d., valparaiso university. gerald l. bepko, indiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. shawn boyne, associate professor oflaw, dean's fellow; grimes fellow. b.a., cornell university; m.b.a., university of minnesota; j.d., university of southern california's gould school of law, m.a., ph.d., university of wisconsin; ll.m., justus-liebig-universitat. robert brookins, professor oflaw. b.s., university of south florida; j.d., ph.d., cornell university. jeffrey 0. cooper, associate professor oflaw. a.b., harvard university; j.d., university of pennsylvania law school. eric r. dannenmaier, professor oflaw, dean 's fellow; grimes fellow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university. james d. dimitri, clinical professor oflaw. b.s., indiana university; j.d., valparaiso university school of law. jennifer a. drobac, professor of law. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. yvonne m. dutton, associate professor oflaw. b.a., columbia university; m.a., university of colorado at boulder; ph.d., university of colorado at boulder; j.d., columbia law school. george e. edwards, carl m gray professor oflaw; faculty advisor to the ll.m track in international human rights law; director, program in international human rights law; john s. grimes fellow. b.a., north carolina state university; j.d., harvard law school. frank emmert, john s. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university of munich law school; ll.m., the university of michigan law school; ph.d., university of maastricht; diploma, european university institute. nicholas georgakopoulos, harold r. woodard professor oflaw. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. carrie hagan, clinical associate professor of law. b.a., university of kansas; j.d., university of cincinnati college of law. john lawrence hill, professor oflaw. b.a., northern illinois university; j.d., ph.d., georgetown university. max huffman, associate professor oflaw; dean's fellow. b.a., cornell university; j.d., university of cincinnati college of law. lawrence a. jegen, iii, thomas f. sheehan professor of tax law and policy. b.a., beloit college; j.d., m.b.a., university of michigan; ll.m., new york university school of law. robert a. katz, professor oflaw. a.b., harvard college; j.d., university of chicago law school. linda kelly hill, m dale palmer professor oflaw. b.a., j.d., university of virginia. max huffman, associate professor oflaw and dean's fellow. b.a., cornell university; j.d., university of cincinnati college of law. andrew r. klein, paul e. beam professor oflaw; chief of staff office of the chancellor of iupui. b.a., university of wisconsin; j.d., emory university school of law. norman lefstein, professor oflaw and dean emeritus. ll.b., university of illinois college of law; ll.m., georgetown university law school. allison martin, clinical professor oflaw. b.s., j.d., university of illinois. deborah mcgregor, clinical professor oflaw and assistant director oflegal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law center. emily morris, associate professor oflaw and dean 's fellow. a.b., harvard university; j.d., university of michigan law school. novella nedeff, clinical associate professor oflaw. b.a., j.d., indiana university. david orentlicher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. b.a., brandeis university; j.d., m.d., harvard university. joanne orr, clinical professor oflaw. b.s., indiana state university; j.d., california western school of law. michael j. pirrs, professor oflaw; dean's fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. fran quigley, clinical professor oflaw, health and human rights clinic, indiana university robert h. mckinney school oflaw; senior advisor, indiana university center for global health. b.a., hanover college; m.a., indiana university; j.d., indiana university robert h. mckinney school of law. florence wagman roisman, william f. harvey professor oflaw. b.a., university of connecticut; ll.b., harvard law school. joan m. ruilenberg, clinical proessor of lw' and director oflegal ana/'sis, research and communication. b.a., mississippi university for women; j.d., indiana university robert h. mckinney school of law. margaret ryznar, associate proftssor oflaw. b.a., university of chicago m.a., jagiellonian university; j.d., uni ersity of notre dame law school. joel m. scllumm, clinical professor of law. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university robert h. mckinney school of law. li a sihaver, .,ssociate professor of law. b.a., m.a., university of chicago; j.d., yale law school. lleiny r. silva, associate profesor of law. b.a., m.a., boston university; j.d., university of connecticut school of lax; ll.m., university of wisconsin law school. fr \nk sulliv\n, jr., profissor of practice. a.b., dartmouth college; j.d., indiana university maurer school of law: ll.m., university of virginia school of law. margaret c. tarkington, associate professor of law. b.a., brigham young university; j.d., j. reuben clark law school, brigham young university. nicolas p. terry, hall render professor oflaw; co-director of'the william s. and christine s. hall center for law and health. b.a., kingston university; ll.m., corpus christi college, university of cambridge. carlton mark waterhouse, associate professor of law; dean's fellow. b.s., pennsylvania state university; j.d. with honors, howard university school of law; m.t.s., emory university, chandler school of theology; ph.d. with honors, emory university. frances watson, clinical professor oflaw. b.s., ball state university; j.d., indiana university robert h. nickinney school of law. lloyd t. wilson, jr.. professor of law; director, joint center for asian law studies; director, chinese law summer program; director, american law for foreign lawyers ll.m program. b.a., wabash college; m.a., duke university; j.d., indiana university maurer school of law. diana r.h. winters, associate professor oflaw. b.a., brown university; m.a., harvard university; ph.d., harvard university; j.d., new york university school of law. r. george wright, lawrence a. jegen iii professor oflaw. a.b., university of virginia; ph.d., indiana university; j.d., indiana university robert h. mckinney school of law. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university of nebraska; ll.m., new york university school of law. edward p. archer, professor oflaw emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, iii, professor oflaw emeritus. a.b., j.d., m.a.l.s., the university of michigan. paul n. cox, professor of law emeritus. b.s., utah state university; j.d., university of utah college of law; ll.m., university of virginia school of law. clyde harrison crockett, professor oflaw emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. falender, professor oflaw emerita. a.b., mount holyoke college; j.d., indiana university robert h. mckinney school of law. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor oflaw emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor oflaw emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor oflaw emeritus. a.b., juniata college; j.d., george washington university law school. william f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of lawnewark. william andrew kerr, professor oflaw emeritus. a.b., j.d., west virginia university; b.d., duke university; ll.m., harvard law school. eleanor dearman kinney, hall render professor of law, co-director of the william s. and christine s. hall center for law and health emerita. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. william e. marsh, professor oflaw emeritus. b.s., j.d., university of nebraska. susanah m. mead, professor oflaw emerita. b.a., smith college; j.d., indiana university robert h. mckinney school of law. h. kathleen patchel, associate professor oflaw emerita. a.b., huntington college; j.d., university of north carolina law school; ll.m., yale law school. ronald w. polston, professor oflaw emeritus. b.s., eastern illinois university; ll.b., university of illinois college of law. kenneth m. stroud, professor oflaw emeritus. a.b., j.d., indiana university-bloomington. james w. torke, carl m gray professor oflaw emeritus. b.s., j.d., university of wisconsin. james patrick white, professor oflaw emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. lawrence p. wilkins, william r. neale professor oflaw emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., university of texas school of law. mary therese wolf, clinical professor oflaw emerita. b.a., saint xavier college; j.d., university of iowa college of law. ruth lilly law library faculty judith ford anspach, professor oflaw and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. susan david demaine, research and instruction librarian. b.a., pennsylvania state university; m.s.l.s., university of kentucky; j.d., university of kentucky. debra denslaw, research and instruction librarian. b.a., franklin college; m.s., university of illinois, urbanachampaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, cataloging and government documents librarian. a.b., taylor university; m.l.s., indiana university. benjamin j. keele, research and instruction librarian. b.a., university of nebraska-lincoln; j.d., indiana university maurer school of law; m.l.s., indiana university school of library & information science. catherine lemmer, head ofinformation services. b.a., lawrence university; j.d., university of wisconsin; m.s., university of illinois. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. miriam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. indiana iieaith law review volume7 2010 articles avoiding the avoidable: why state laws need to protect kids from airbags carrots or candy in corner stores?: federal facilitators and barriers to stocking healthier options notes get "hip" america: using the "healthy indiana plan" as a model for decreasing the number of uninsured americans one state at a time under the influence: an examination of the tactics pharmaceutical companies use to manipulate physicians improving indiana's mandatory immunization programs saving money, not lives: why the vns claims adjudication system denies due process to veterans with post-traumatic stress disorder and how the va can avoid judicial intervention issue 1 mary ann chirba-martin sheila fleischhacker joel gittelsohn barbara e. molargik-fitch shena t. wheeler matt lasher contessa m wilson indiana university school of law indianapolis iupui indiana health law review, volume7 executive managing editor rachel k. hebner executive production editors susan kindig, m.d. shena wheeler executive business editor stephen donham note development editors lauren hulls hilari a. sautbine adam bolerjack matt lasher roxanna bell j.c.brown jennifer cooper bobby a. courtney, m.a. matthew derringer allison neil deyoung kelly earls elizabeth eichholtz amy halsey paul jansen editor-in..chief brian r. bouggy articles editors trampas whalin chris arrington anna ly-pham ashley arthur members executive notes editor marc a. menkveld executive articles editor mary beth arnold 2010 executive symposium editor contessa m. wilson, pharm. d. associate editors melissa reynolds marc steams barbara molargik-fitch beth ann barnes kristin mccreary elliot mckinnis lucas mlsna dennis mullen vijaypatel melissa stuart, m.s. andrea white 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president of the university. ph.d., australian national university. charles r. bantz, chancellor, indiana university-purdue university-indianapolis. b.a., m.a., university of minnesota; ph.d., the ohio state university. gary r. roberts, dean and gerald l. bepko professor of law. b.a., bradley university; j.d., stanford university. pauln. cox, vice dean and centennial professor of law. b.s., utah state university; j.d., university of utah; ll.m., university ofvirginia. james p. nehf, associate dean for graduate studies and cleon h. foust fellow; professor of law and johns. grimes fellow. b.a., knox college; j.d., university of north carolina law school. claire grove, assistant dean for graduate studies. b.a., indiana university; j.d., indiana university school oflaw-lndianapolis. jonna kane macdougall, assistant dean for institutional advancement. b.a., m.a., indiana university; j.d., indiana university school of law-indianapolis. chastitythompson,assistantdeanforprofessionaldevelopment.a.s.,b.a.,alabamastate university; m.b.a., auburn university; j.d., indiana university school of law­ indianapolis. eijzabethailington, director for external affairs. b.a., indiana university; m.a., m. phil., new york university. teresa (terri) j. cueil..ar, director of technology services. b.s., st. bonaventure university, new york. joyce m. hertko, director of major gifts. b.a., knox college; m.s., western illinois university; ph.d., indiana university. amanda kamman, director for development. b.a., indiana university. patriciak.kinney, director of admissions. b.s., purdue university; j.d., indiana university school of law-indianapolis. virginia marschand, director of administrative and fiscal affairs. b.a., m.p.a., indiana university; j.d., indiana university school of law-indianapolis. heather mccabe, director, public health law program, william s. and christine s. hall center for law and health. b.a., m.s.w., indiana university; j.d., indiana university school of law-indianapolis. sonja rice, egypt program director. b.a, purdue university; j.d., indiana university school of law-indianapolis. law anda w. ward, director of pro bono program and public interest. b.a., murray state university; m.a., illinois state university; m.s., old dominion university; j.d., indiana university school of law-indianapolis. tamaramcmnlian,associate director of professional development. b.a., southern illinois university-carbondale; m.s.w., southern illinois state university-carbondale; j.d., depaul university college of law susie agnew, assistant director of student services. clark college. wiwam j. baker, assistant director oftechnology services. karen h. miller, assistant director for admissions. midway college. lisa schrage, assistant director for donor relations. b.s., marian college. faculty cynthia m. adams, clinical professor of law and co-director of the latin american law program. b.a., kentucky wesleyan college; j.d., indiana university school of law-indianapolis. judith ford anspach. professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. cynthia baker, clinical associate professoroflawanddirector, program on law and state government. b.a., j.d., valparaiso university. geraidl. bepko,indiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., itt/chicago-kent college of law; ll.m., yale law school. shawn boyne, associate professor of law and dean's fellow. b.a., cornell university; m.b.a., university of minnesota, j.d., university of southern california's gould school of law, m.a., university of wisconsin, l.l.m., justus-liebig-universtat. karen e. bravo, associate professor law; johns. grimes fellow and dean's fellow. b.a., the university of the west indies; j.d., columbia university school oflaw; ll.m., new york university school of law. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kennetii d. chestek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law, daniel h. cole, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school. jeffreyo. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. eric dannenmaier, associate professor of law and dean's fellow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university. james d. dimitri, clinical professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer a. drobac, professor of law and director, central and eastern european law summer program. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. george e. edwards, carl m gray professor of law; faculty advisor to the ll.m track in international human rights law; director, program in international human rights law and johns. grimes fellow. b.a., north carolina state university; j.d., harvard law school. frank emmert, johns. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university ofmunich law school; ll.m., the university ofmichigan law school; ph.d., university ofmaastricht; diploma, european university institute. nicholasgeorgakopoulos,haro/dr. woodardprofessoroflaw. ptyhion nomikis, athens university school of law; ll.m., s.j.d., harvard law school. carrie hagan-gray, clinical associate professor of law. b.a., university of kansas; j.d., university of cincinnati, college of law. john lawrence hill, professor of law; at:{junct professor of philosophy and johns. grimes fellow. b.a., northern lllinois university; j.d., ph.d., georgetown university. linda kelly hill, m dale palmer professor of law. b.a., j.d., university of virginia. max huffman, associate professoroflaw and dean's fellow. b.a., cornell university, j.d., university of chicago college of law. lawrence a. jegen, iii, thomas f. sheehan professor of tax law and policy. a.b., beloit college; j.d., m.b.a., the university of michigan; ll.m., new york university schooloflaw. robert a. katz, professor of law and johns. grimes fellow. a.b., harvard college; j.d., university of chicago law school. eleanor d. kinney, hall render professor of law, co-director of the william s. and christine s. hall center for law and health. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. andrew r. klein, paul e. beam professor of law. b.a., university of wisconsin; j.d., emory university school of law. normanlefstein,professoroflaw and dean emeritus. ll.b., university oflllinois college of law; ll.m., georgetown university law school. maria pabon lopez, professor of law and dean's fellow. b.a., princeton university; j.d., university of pennsylvania law school. gerard n. maguocca, professor of law; co-director, chinese law summer program and johns. grimes fellow. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor of law. b.s., j.d., university of illinois. deborah mcgregor, clinical professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. mary h. mitchell. alan h. cohen professor of law. a.b., butler university; j.d., cornell law school. emily morris, associate professoroflawanddean 's fellow. a.b., harvard university, j.d., university of michigan law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. david orentucher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. a.b., brandeis university; j.d., m.d., harvard college. · joanne orr. clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, associate professor of law and dean's fellow. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kathleen patchel, associate professor of law. a.b., huntington college; j.d., university of north carolina law school; ll.m., yale law school. michael j. pitts, associate professor of law; dean's fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. peter a. prescott, associate professor of law. b.a., augustana college; m.s., the university of chicago; m.p.a., the university of texas at austin; j.d., the university of houston law center. fran quigley, visiting professor. b.a., hanover college; m.a., indiana university; j.d., indiana university school of law-indianapolis. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. gary r. roberts, dean and gerald l. bepko professor of law. b.a., bradley university; j.d., stanford university. joan m. ruiitenberg, professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university school of law-indianapolis. joelm. schumm, clinical professor of law and director, judicial extemship program. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university school of law-indianapolis. frances watson, clinical professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. lloyd t. wilson, jr., professor of law and co-director, chinese law summer program. b.a., wabash college; m.a., duke university; j.d., indiana university school of law-bloomington. maryt. wolf, clinical professoroflawand director of clinical programs and externships. b.a., saint xavier college; j.d., university oflowa college of law. r. george wright, lawrence a. jegen iii professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law-indianapolis. emeriti faculty thomas b. alungton, professoroflaw emeritus. b.s., j.d., university ofnebraska; ll.m., new york university school oflaw. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, iii, professor of law emeritus and director of the law library emeritus. a.b., j.d., m.a.l.s., the university of michigan. clyde harrison crockett, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. falender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school of law-indianapolis. david a. funk. professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. j~y · w. grove. proft:ssor of law bmeritus. a.b., juniata college; j.d., george · .w ashingtori university law school. · · ' , · . ·· . ' william f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university · · ·· of missouri; j.d:, ll.m., georgetown university law school. 'w • .wii:.i.iam hodes, professor of law emeritus, ab., harvard college; j.d., rutgers university school of law-newark. henry c. karlson, professor of law emeritus. aij., jj>., ll.m., university of lllinois college of law. william andrew kerr, professor of law emeritus. ab., west university; b.s., duke university; j.d., ll.m., harv-ard law school. william e. marsh, professor of law emeritus. b.s., j.d., university ofnebraska. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., .. l.jniversity of illinois college of law. kenneth m. stroud, professor of law emeritus. ab., j.d., indiana universitybloomington. , . . james w. torke, carl m gray professor of law emeritus. b.s., j.d., university of wisconsin. · · james patlui::k·whi'fe, professor of law emeritus. a.b., university oflowa; j.d., ll.m., · george washington university law school. lawrence p. wn.kins, william r. neale professor of law emeritus. b.a., the ohio state university; j.d., capitol universityi.aw school; ll.m., university oftexas school of law. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. susan boland, head of information services. b.a., monmouth college; m.s., university of illinois; j.d., illinois university college of law. debra densla w, reference librarian. b.a, franklin college; m.s., university of lllinois, urbana-champaign; j.d., valparaiso school of law. richarj) hljmp:hlmy, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johntino, assistant director for technical services. ab., taylor university; m.l.s., indiana university. . chris e. lond, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. stevenr. miller, reference librarian. b.s., lebanon valleycouege ofpennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. . mahnaz k. moshfeoh, serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. mooam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyosmotsu,automated services and media librarian. a.a., parkland college; a.b., m.s., c.a.s., university of illinois. indiana health law review volume7 issue 1 table of contents articles avoiding the avoidable: why state laws need to protect kids from airbags ........................... mary ann chirba-martin carrots or candy in corner stores?: federal facilitators and barriers to stocking healthier options .............................................. sheila fleischhacker notes get "hip" america: using the "healthy indiana plan" as a model for decreasing the number of uninsured joel gittelsobn 23 americans one state at a time ............................... barbara e. molargik-fitch 57 under the influence: an examination of the tactics pharmaceutical companies use to manipulate physicians ..................................................... shena t. wheeler 89 improving indiana's mandatory immunization programs ................................................................ matt lasher 117 saving money, not lives: why the va 's claims adjudication system denies due process to veterans with post-traumatic stress disorder and how the va can avoid judicia/intervention .............................................. contessa m. wilson 157 2010 george p. smith, ll a professor oflaw at catholic university in washington, d.c., since 1977, professor george p. smith is an established scholar in the field of bioetbics and health law-with over 175 entries in his bibliography, which includes twelve books, the most recent being human rights and biomedicine (kluwer 2000). among his research affiliations at major universities have been those at chicago, columbia, northwestern, vanderbilt, virginia, princeton, california at berkeley, the hoover institution at stanford, and the max planck institute in heidelberg. professor smith's consultantships have included those with the international bioetbics committee for the unesco declaration on the protection of the human genome, the house committee on science and technology of the u.s. congress, the new south wales law refonn commission in australia, and the heritage foundation. a frequent visitor to the university of cambridge in england, he has held fellowships at wolfson and emmanuel colleges as well as at clare hall and hughest hall. professor smith received an australian-american fullbright foundation award in 1984 and is a regular visitor to the continent-holding visiting pro­ fessorships at the university of new south wales and the university of sydney. in 1985, the indiana university institute of advanced study con­ ferred a citation of merit upon professor smith for his "path-breaking inter­ disciplinary research and writing on medical and biological issues as they relate to the norms oflaw and ethics." the university also conferred a distin­ guished alumni award upon him in 1985 and an honorary degree in 1998. professor smith is the founding faculty editor of the journal of contem­ porary health law and policy at catholic university and a life member of the american law institute. the vagaries of informed consent george p. smith, if' introduction and overview within the phrase informed consent, both manipulative and coercive vectors of force can be found. first, the health care provider [m]ust gain the 'consent' of the patient to prove that she was not physically or psychologically forced into a procedure. we then insist that this consent be 'informed, • recognizing that if a patient readily agrees to something about which she understands little or about which she has a false understand­ ing, we have somehow or other abrogated or sidestepped her autonomous decision-making rights.1 the patient-physician relationship is central to the foundations of medical morality. from it emerge normative guidelines that effectuate ideally the end of medicine-to render "a right and good healing action in the interests of a particular patient."2 technical competence, then, is shaped by this goal and, indeed, the very acts of the medical profession are to be con­ sidered unauthentic if they neglect to fulfill the real expectation of technical competence. 3 it is upon both the patient-physician relationship and the acknowledged technical competence built by a ''participatory moral agency" that forces disclosure of all levels of information necessary for the patient's valid choice or genuine consent to medical treatments. 4 * ll.d. 1998, indiana university; ll.m. 1975, columbia university; j.d. 1964, indiana university;b.s.196l,indiana university. professor of law, the catholic university of america, washington, d.c. parts of this article are drawn from my book, leoal and healthcare ethics for thb elderly (1996). 1. wiw..ardgaylin&brucejenninos, the perversion of autonomy 159 (1996). see generally edmund d. pellegrino, patient cl physician autonomy: conflicting rights and obligations in the physician-patient relationship, 10 j. contemp. heal1ll l. & pol'y 47 (1994) [hereinafter pellegrino, autonomy]; edmund d. pellegrino, the human person, the physician and the physician's ethics, 621jnacre q. 74 (1995) [hereinafter pellegrino, human person]. 2. edmund d. pellegrino, toward a reconstruction of medical morality: the primacy of the act of profession and the fact of lllness, 4 j. med. & phil. 32, 47 (1979) [hereinafter pellegrino, reconstruction]. 3. id. at49. 4. /d. seegenerallydanielp.sulmasy,thehealbr'scawno:aspirmjautyr>r physiciansandonierheal1licareprchssionals(1997);'diomasszasz,thetheolooy of medicine ch. 1 (1977). 112 indiana health law rev1ew [vol. 1:109 while the desire for obtaining information may be seen as stronger than the one for actually making the determinative health care decision itself, not every patient welcomes such information.5 indeed, realizing that most indivi­ duals make decisions rather badly forces many to choose to delegate medical decision-making to others. 6 for those declining to make their own decisions, it is quite simply psychologically attractive to pass responsibility for hard choices to others. 7 when this delegation occurs, it might be wise to consider developing a "full social impact calculus" which in turn considers all the people affected by it8-immediate family members, close friends, social workers as well as spiritual and health care providers. this calculus could be taken when the initial decision for obtaining treatments or accessing them are made. a full social impact calculus would result in some cases even arising where the sum of the social, economic, and medical consequences "on others may outweigh the impact on the person most affected."9 patient information deficits must be remedied by the physician to the fullest extent possible.10 the information disclosed must be complete, clear, and understandable in the patient's own language so that the patient knows not only the nature of his or her illness, its prognosis, and the alternative modes of treatment, together with their cost and probable effectiveness, but also the degrees of discomfort and the ultimate side effects on the quality of life. this duty of disclosure cannot be exercised by the physician on the grounds of patient ignorance or harm. to do so would underscore the inequality in information between patient and doctor and obstruct the goal of a morally valid consent that in tum is the memorialization of the patient's individual moral agency.11 the physician must always guard against manipulating patient choice and consent in order to simply accommodate his own personal or social philosophy. setting valid limits on the degree to which manipulated consent is morally permissible is difficult. two major situations are commonly recognized in which a physician can, and indeed should, exert moral agency for the patient and make the value choice on his behalf. the most common 5. carle. schneider, thepracticeofautonomy,patients,doctors&medical decisions 110 (1998). see terrance mcconnell, inauenable rights: the limits of consent in medicine and the law 77, 78 (2000) (maintaining the position that physicians are not obligated to comply with such patient wishes because such a waiver is valid only if it is both voluntary and informed). 6. schneider,supranote5,at99. seealsomarka.iiau.etal.,healthcarelaw and ethics 208 (6th ed. 2003). 7. schneider, supra note 5, at 175. 8. roger b. dworkin, medicall.4w and ethics in the post-autonomy age, 681nd. l.j. 727,737 (1993). 9. ld. seegenerallyrogerb.dworkin,limits:theroleofthelawinbioethical decision making cb. 7 (1996). 10. pellegrino, reconstruction, supra note 2, at 50. but see veatch, infra note 47 (discussing the therapeutic privilege to withhold information). 11. pellegrino, reconstruction, supra note 2, at 50. 2004] vagaries of informed consent 113 case is where the patient and/or family request the physician to act according to their wishes-because of their emotional unwillingness or intellectual inability to deal with the immediate situation. in cases of this nature, it would be a failure of the authenticity of his act of profession for the physician not to assume moral agency and decide what course of action should be taken. when dealing with surrogate decision makers, it is even more important for the physician to ascertain with certainty that the surrogate is being guided by the best interests of the patient. 12 the second situation in which a physician should exert moral agency for the patient occurs in emergency cases, in an intensive care or coronary care unit, or in an operating or emergency room. because of the urgency of the situation, it is impossible for the physician to consult the patient; therefore, he must consult the patient's immediate family or a designated surrogate decision maker. in both of these situations, the physician's golden rule should be to act in such a manner as to "accord the patient the same opportunity to express or actualize his own view of what he considers worthwhile," as would be desired by the physician himself.13 this rule, then, reinforces the mandate not only to bring compassion to the patient's illness, but exhibit the mandate as a "conscious advertence" in the act of profession and the act of medicine as well.14 the other party to informed decision-making is obviously the patient. thus, the ethics of the good patient require truthfulness in the information given to the physician; avoidance of manipulation; faithful following of mutually agreed upon recommendations; self--education for comprehension of the facts disclosed by the physician; promise not to consult another physician (absent suspicion of either dishonesty or malpractice); and acknowledgment of a partial obligation to participate in reasonable therapeutic experiments designed to promote a healing of the patient" s disease or those directed toward the discovery of possible cures for his or her own disease for others (non therapeutic), provided the other rules for professional behavior are followed.15 12. id. at 51. 13. id. 14. id. 15. id. at 52.54-5 5. see len doyal, them oral importance of informed consent in medi­ cal research: concluding reflections, in informedconsentinmedicalresearch 313 (len doyal & jeffrey s. tobias eds., 2001) (arguing that certain types of medical researchepide­ miological, for example-should be exempted from the informed consent requirement and, further, that in certain other cases where the research subject is incompetent, as with children having the consent of their parents, or in trauma cases where there is an acceptable risk-benefit ratio). see daniel callahan, whatpricebe'iterhealth?: jiazardsoftheresearch imperative(2003)(arguingthetherapeuticlnon-therapeuticdistinctiongivesriseto''therapeu­ tic misconception" which arises when "a clinician researcher carries out research of no expected or intended benefit to a patient but which the patient believes will offer a chance of benefit"). see also guido calabresi, reflections on medical experimentations in hu1tlll1ls, 98 daedalus 387, 401 (1964) (advocating some form of consent should always be required which seeks to strike a balance between present and future lives). see generally jonathan montgomery,lnform114 indiana health law review [vol. 1:109 what is seen in totality, then, between the patient and the physician is a set of mutually binding obligations that, if met, assure informed decision-making in health care services. 16 the ongoing debate regarding the efficacy and integrity of the doctrine of informed consent and its application has been termed "oblique and inconclusive,"17 and indeed a little more than a "fairy tale."18 the reason for this state of affairs is attributed to a structural weakness reflecting not only a rapacious health care delivery system that is increasingly cost-conscious, 19 complex, and sophisticated,20 but also by constraints imposed by the tort law system, human psychology, and the physician-patient relationship,21 all of which are largely intractable. 22 coupled with these foundational issues is the recognition that the adequate levels of both empirical research and analysis, together with comparative risk evaluation necessary to resolve the uncertain­ ties, is not being pursued.23 yet, for all of the weaknesses, the doctrine of informed consent and its offspring in elder care, negotiated consent,24 serves a significant purpose in contemporary society-both as a construct and often a template for establish­ ing an interdependent relationship, if not therapeutic partnership, between the patient and his or her physician where truth-telling becomes the crux of the doctrine and a true moral relationship between both parties is recognized. 25 the purpose of this article, then, is to probe the foundations and applications of informed consent in a variety of situations and thereby test its validity. the conclusion to be drawn from this analysis is that while the doctrine has yet to become an integral part of the ethos of medicine, 26 it still provides an important mechanism for maintaining a purposeful discourse ed consent in clinical research with children, in inrormed consent in medical research, supra note 15, at 173. 16. see arthur l. caplan, informed consent and provider· patient relationships in rehabilitation, 69 archives physicalmed. &rehabhxration 312 (1988); dan w. brock, the ideal of shared decision making between physicians and patients, 1 kennedy inst. ethics j. 28 (1991). 17. peter h. schuck, rethinking informed consent, 103 yale l.j. 899, 904-05 (1994). 18. jay katz,lnformed consent-mustlt remain a fairy tale?, 10 j. contemp. health l. &pol'y 69 (1993). 19. seegenerallytimothys.jost,disbntitlement: thethreatsfacingourpubuc healthcare programs and righrs-based response (2003); eleanor d. kinney, protecting american health care consumers (2002); george p. smith, ll, distributive justice and health care, 18 j. contemp. health l. & pol'y 421 (2002). 20. see generally schneider, supra note 5. 21. pellegrino, autonomy, supra note 1; pellegrino, human person, supra note 1; schneider, supra note 5, at 205; schuck, supra note 17, at 905. 22. schuck, supra note 17. at 905. 23. /d. 24. see generally harry r. moody, from informed consent to negotiated consent, 28 gerontologist 64 (supp. 1988). 25. ga ylin & jennings, supra note l, at 55. 26. katz, supra note 18, at 91. 2004] vagaries of informfd consent lls between physician and patient and, as such, nurturing and preserving their essential partnership of healing and trust. 27 i. malpractice and informed consent a. professional or lay standards a claim for malpractice is recognized essentially when a patient, as a direct result of a physician's failure to render that level of care consistent with what would have been given by other practicing physicians in the conununity in question, is injured. 28 thus, the standard of conduct against which the defending physician's behavior is measured is tied to the conduct other similarly situated professionals in the field would have followed under the same or similar circumstances. the end result of this evaluation process is that the objective standard of reasonableness is thereby excluded totally from the evaluation.29 as to the elements of establishing a cause of action for failure to obtain informed consent for either a medical treatment or procedure, there is less uniformity of view.30 indeed, under older case law, the duty to obtain informed consent for a medical intervention was inherent in the essential idea that nonconsensual touching was, and is, a legal battery.31 modem case law, however, now takes one of two approaches to the duty to obtain informed consent,32 yet treats the central issue as one ofnegligence.33 27. see gemrally pellegrino, autonomy, supra note 1; pellegrino, human person, supra note 1; edmund d. pellegrino, rationing health care: the ethics of medical gatekeeping, 2 j. contemp. health l. & pol'y 23 (1986) [heleiruifter pellegrino, gatekeeping]. see also mark a. hall, law, medicine and trust, s5 stan. l. rev. 463, 478 (2002} (maintaining that without a minimal level of trust. patients will neither disclose infonnation to the physician nor follow medical recommendations made to bim or her). 28. laura hunter dietz, annotation. physicians, surgeons, and other healers, 61 am. jur. 2d physiciqns § 202 (1981). see also hallet al, supra note 6, at 201, 203, 210. 29. dietz, supra note 28. 30. id. see aaron d. twerski & neil b. cohen, informed decision making and the law of torts: the myth of justiciable caustztion, 1988 u.iu.. l. rev. 007 (1988). 31. dietz,supranote28,§§ ls0-52. seefowlbrv.harperbtal,lawoftorts§3.2 (2ded. 1986). 32. hunter l. prillaman, a physician's duty to inform of newly developed therapy, 6 j. contemp. health l. & pol'y 43, 44 (1990). 33. dworkin, supra note 8, at 729. since the 1957 decision in salgo v. leland stanford jr. university board oftrustees, the courts have been emphasizing and developing a negligence offailure to use due care theory of liability. 317 p.2d 170, 181 (cal. ct. app. 1959). this theory in tum places the physician in default for failing to educate adequately his patient to the collateral risks involved in the treatment. indeed. salgo provided the groundwork for the explosion of cases dealing with informed consent. in salgo, as now, the physician is confronted with a perplexing problem: namely, how to balance the patient's need to know the risks and alternatives to treatment in order to give an informed consent with the individual patient's mental and emotional condition to accept and understand the medical infonnation. id. see also 116 indiana health law review [vol. 1:109 some states require a professional standard to be followed that in tum imposes a duty upon all physicians to inform their patients of not only the risks, but also the alternatives to any proposed medical treatment in the same manner as other physicians would practicing in the community.34 accord­ ingly, in a 1981 illinois case,35 the court held that applying the reasonable medical practitioner standard of informed consent meant that there must indeed be specific expert medical testimony "of the necessity to inform patients of possible altematives."36 consequently, adherence to that level of care given in the relevant community by other practitioners applies both to malpractice actions and the separate action of failure to obtain informed consent.37 other states choose to apply the lay or prudent patient standard of informed consent, thereby requiring a physician to inform his patient of all sources and degrees of information which an average, ordinary, and reason­ able patient should and would require in order to make an informed decision regarding the need to submit to a proposed treatment therapy. 38 under this standard of informed consent: [a] physician is liable to his or her patient if (l) the physician fails to disclose any risk in the recommended treatment, or the existence of any alternative method of treatment, that a reasonable person would deem material in deciding whether to undergo the recommended treatment; (2) the patient would have foregone the recommended treatment had he or she known of the undisclosed information; and (3) as a result of david thomasma & edmund d. pellegrino, medicine, science, self-interest: value sets in conflict in human experimentation, in research on human subject's: ennes, law and socialpoucy xvii passim (david n. weisstub ed., 1998). therefore, under sal go, a physician owes a duty to his patient to disclose facts necessary to the formation of an intelligent consent and, further, subjects himself to liability for violation of that duty. sal go, 317 p .2d at 181. at best confusing, the salgo rule allows plaintiffs counsel to argue that there must be full disclosure because of the established duty to disclose. however, a court may use salgo as justification for holding in favor of a defendant on the issue of the adequacy of disclosure-sustaining the proposition that the amount of information the physician gave the patient was sufficient for him to understand the risks and alternatives of the proposed treatment. myers, infra note 44, at 1399. the discretion allowed to physicians has tended to subject them to liability in cases involving high risk and to exonerate them when a court considers the risk to be light. id. 34. hondroulis v. schuhmacher (hondroulis ll), 553 so. 2d 398 (la. 1988). 35. ziegert v. s. chi. cmty. hosp., 425 n.e.2d 450 (lll. app. ct. 1981). 36. prillaman, supra note 32, at 45. 37. jd. 38. ld. see generally lnst. ofmed., responsffii.e research: a systems approach to protecting research participants (daniel d. federman et al. eds., 2003); kenneth getz & deborah borfitz, informed consent: a guide to the risks and benerts of volunteering for cunical 1'rials (2002); 45 c.f.r. § 46.101 (2004); 21 c.f.r. § 50.1 (2004). 2004] vagaries of informed consent the recommended treatment, the patient actually suffers an injury the risk of which was undisclosed, or the patient actually suffers an injury that would not have occurred had the patient opted for one of the undisclosed methods of treat­ ment.39 ii. the foundational paradigm 117 the 1972 case of canterbury v. spence40 presents a modem, comprehen­ sive, and focal paradigm of the legal concept of informed consent in applica­ tion. in canterbury, a young boy complaining of back pain submitted to a myelogram which revealed a filling defect. the boy's mother was contacted after the test and an operation was recommended by dr. william t. spence, the attending physician, stating that such an operation was "not anymore [serious] than any other operation.'>41 the boy submitted to the operation without being informed that paralysis was a risk of the procedure. mrs. canterbury arrived at the hospital after the operation and signed a consent form. the boy fell from his bed a day after the operation while, without assistance, he attempted to void. he thereupon became paralyzed and was required to undergo a second surgery. this time, mrs. canterbury signed a consent form before the operation. years later, the youth ''hobbled about on crutches, a victim of paralysis of the bowels and urinary incontinence. "42 at trial, dr. spence testified that there was only a one percent risk of paralysis occurring after this type of surgery. the central issue of the case was the scope and application of the doctrine of informed consent because there is a duty to disclose risks of a procedure, the scope of that duty should be known. any standard set in terms of what is done in the medical profession will be at odds with the patient's prerogative to decide on prospective therapy. this "right of self-decision shapes the boundary of the duty to reveal.'>43 in order that the patient's interest in achieving his own determination of treatment is fulfilled, it is the law which must set the standard for adequate disclosure. 44 the test enunciated in canterbury is that a "risk is thus material when a reasonable person, in what the physician knows 39. neal v. lu, 530 a.2d 103, 111 (pa. super. ct. 1987). see also festa v. greenberg, 511 a2d 1371 (pa. super. ct. 1986); salis v. united states. 522 f. supp. 989 (pa. d. 1981). 40. canterbury v. spence, 464f.2d 772 (d.c. cir.1972). accord wilkinson v. vesey, 295 a2d676 (r.i.1972). seealsocobbsv. grant.502p.2d 1 (cal.1972);natanson v. kline, 350 p.2d 1093 (kan. 1960), clarified by 354 p.2d 670 (kan. 1960); schloendorffv. soc'y of n.y. hosp., 105 n.e. 92 (n.y. 1914), overruled on other grounds by bing v. thunig, 143 n.e.2d 3 (n.y. 1957). 41. canterbury, 464 f.2d at 777. 42. id. at 776. 43. ld. at 786. 44. see michael justin myers, comment. informed consent in medical malpractice, 55 cal. l. rev. 1396, 1407-10 (1967). 118 indiana health law review [vol. 1:109 or should know to be the patient's position, would be likely to attach signifi­ cance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.',..5 this includes a discussion ofthe inherent and potential dangers of the proposed treatment, the alternatives to that treatment, and the likely results if the patient remains untreated. the courts have noted two exceptions to the general rule of disclosure. the first is where the person is unconscious or otherwise incapable of con­ senting and there is imminent harm that would result from failure to treat, which in tum outweighs any harm threatened by the proposed treatment.46 if possible, consent of relatives should then be obtained. the second exception arises when the disclosure itself threatens the patient and thus becomes infeasible from a medical point of view. the critical inquiry, then, would be whether the physician was guided by sound medical judgment 47 this privi­ lege does not carry with it the paternalistic notion that the physician may remain silent simply because diligence might prompt the patient to forego the physician's recommended therapy.48 the danger of this second exception is that it may be judged by a subjective, hindsight test canterbury speaks to this concern and resolves it by requiring a determination of whether a prudent person in the patient's position would have decided to undergo treatment "if suitably informed of all perils bearing significance.',..9 this affords opportunity for medical testimony regarding the relevance of certain risks, as well as other testimony by anyone 4.5. canterbury, 464 f.2d at 787. 46. see dunham v. wright, 423 f.2d 940, 941-42 (3d cir. 1970). 47. see roberts v. wood, 206 f. supp . .579, .583 (s.d. ala. 1962). see also thomas beauchamp & james chn.dress, principles of biom!!dical ethics ch. 3 (1979). a therapeutic privilege exists to withhold information from a patient if it is either considered potentially harmful or it would cause any counter-therapeutic deterioration-no matter bow slight-in either the patient's physical. psychological. or emotional well being. robert m. veatch, medical ethics 203-04 (2d ed. 1997). the "urgency of the situation" justifies this exception to the doctrine of informed consenl jay katz, experimentation with human beings: the authority of the investigator, subjeci', pror:ssion and state in the human experimentation process 37, 84 (1972). see also kathleen m. boozang, the therapeutic placebo: the case for patimt deception, .54 fla. l. rev. 687, 746 (2002) (arguing, for example, that if viewed as effec:tive treatment. with a therapeutic effect being achieved by its prescription and use. the repn!selltation that placebo use is therapy or medicine is neither untrue nor unethical); hail et al,iiipra note 6, at 207; george j. annas, questing for grails: duplicity, betrayal and &if-deception in postmodern medical research, 12 j. contemp. heal'ih l. & pol'y 297, 300, 314 (1996) (asserting that the very concept of therapeutic research should be eliminated altogether since it c:onfuses the ideology of medicine with the ideology of science). 48. myers, supra note 44, at 1409-10. su gemrally allan meisel, the "exceptions" to the lliformed consent doctrine: striking a balance between competing values in medical decisionmaking, 1979 wis. l. rev. 413. 49. canterbury, 464 f.2d at 791. 2004] v agarjes of informed consent 119 having sufficient knowledge and capacity to testify. the courts thus assume a detenninative role in assessing liability.50 in the pre-canterbury period, courts sought to enforce a narrower objective test for materiality (reasonable doctor) and a broad-based test for causation (subjective patient). with canterbury, a broad test for materiality is advanced (reasonable patient) and a narrower objective test for causation (what a reasonable patient would have chosen) preferred. 51 criticism has been maintained that with canterbury the courts are incorrectly treating infonned consent as yet another branch of negligent medical practice instead of recognizing the patient's interest in autonomy and his or her right to make an informed choice about medical care. this right is the key interest protected by the infonned consent doctrine. however, these criticisms are muted when hard questions are raised regarding how to value·the protected interest and determine damages for interference thereto. 52 a alternative treatment utilizing either the professional standard or the lay standard of informed consent. a physician is under a duty not only to· inform his patient of appropriate alternative treatments, in addition to the alternative of no treatment at all, but also to describe and evaluate the benefits and the risks of those treatments to his at-risk patient. 53 not every "conceivable alternative to every detail of treatment'' need be provided, however. 54 setting the limits of a physician's duty to inform patients of alternative treatments continues to be a struggle for the courts. if a professional standard of informed consent is adhered to, much difficulty in application is alleviated, since a jury panel will seek to decide the issue in conflict by comparing the testimony of competing medical experts." if, however, the lay standard is followed, the jury determination is more complex because an evaluation must be made of what an ordinary, reasonable patient would both want and need to know under similar circumstances. 56 50. landmark examples of the way in which courts have treated the application of informed consent include: com v; french. 331 p.2d 850 (nev. 1958) (physician held liable where mastectomy was performed with a signed consent form, but patient had told physician that she did not want anything removed); dirosse v. wein. 24 a.d.2d 510 (n.y. 1965) (failure to tell of the danger of exfoliative dermatitis from gold treatment for rheumatoid arthritis, resulting in exfoliative dermatitis, imposed liability on the physician); and darrah v. kite, 32 a.d.2d 208 (n.y. app. div. 1969) (failure to give adequate and timely explanation of the risks of ventricolograms, imposed liability on a neurologist). 51. twerski & cohen, supra note 30, at 615 n.30. 52. jd. at 620 n.47. 53. prillaman, supra note 32, at 47. 54./d. 55. jd. at 48. 56./d. 120 indiana health law review [vol. 1:109 obviously, a decision reached according to this standard ·requires considerable and complex analysis of the credibility of opinions of opposing experts on varying community standards. of additional complexity is the court's need to comprehensively instruct a jury on the elements of a medically acceptable alternative before the jury can be allowed to decide whether the average reasonable patient would indeed have wanted to know of the alternative. 57 medical acceptability is the criterion by which a fact finder determines whether an alternative treatment is to be disclosed. 58 the obvious difficulty here is fully comprehending those components or elements of a particular treatment, especially a new one, that make it acceptable and determine to whom it must be found acceptable.59 "in terms of a doctor's duty to disclose, this issue can be broken down into two parts. first, what criteria, objective or subjective, make a particular treatment acceptable? second, are there additional factors which create (or excuse) the particular physician's duty to know about the treatment?"60 every new medical treatment, whether it be surgery, drug therapy or an exotic technique, is initially experimental.61 in those cases where a lay approach to informed consent is followed, it must be first recognized that it cannot be extended effectively to determine what specific alternative treatments are medically acceptable, although it may well indeed be used as a mechanism through which acceptable treatments are revealed. 62 the juries applying the lay standard or approach to determine what a reasonable patient would have considered medically valid and acceptable leads to an interesting quandary for the concerned physician: the physician would never be in a position to know precisely which alternatives he or she must describe. this in turn could drive the physician to describe even quack treatments for fear that a future jury could fmd that a reasonable patient might have wished to be informed of such treatments. 63 a wiser approach acknowledges the standard for medical acceptability is based solely on the perception of the reasonable practitioner.64 here, the pivotal inquiry would not necessarily be whether a reasonable practitioner would inform a patient of the particular alternative. rather, the question to be raised would be simply whether an average, reasonable practitioner would 57. id. 58. id. at 52. 59. prillaman, supra note 32, at 52. 60. id. 61. ld. in a landmark 1990 case in california, it was determined that an individual patient must first give an informed consent to a surgical procedure that would in turn yield tissues which would be transformed, subsequently, through genetic engineering, into commercial products of considerable value. moore v. regents of the univ. of cal., 793 p.2d 749 (cal. 1990). 62. prillaman, supra note 32, at 57. 63./d. 64./d. 2004] vagaries of informed consent 121 believe the treatment was a viable, medically acceptable alternative; or stated otherwise, whether it was recognized as an appropriate modality of treatment by a significant number of acknowledged experts in the field. 6s the role of expert testimony then would essentially be to explore both the number and the respectability of those accepting the treatment.66 developing and following this standard would allow a physician to: [a]void the danger of having to describe the theories of quacks or to. explain treatments too new to have a track record, but could still be held to hav~ a duty to keep up with the relevant literature and other sources of information, and to inform patients of new treatments as they met the criteria of acceptance.67 b. future treatment it is often maintained that if a particular medical treatment were to be classified as futile, an attending physician is under no obligation to provide it to his or her patient. indeed, the assertion goes even further: namely, that the physician needs not even advise a patient of the existence of such treatment.68 judging the futility of any treatment is, arguably and correctly, a medical matter. 69 no input from the patient is thus required 70 since a futile treatment offers no benefit to the patient, it .can be argued that a physician has neither obligation to render treatment of a non-~neficent nature nor-for that matter-does a patient have a right to ~d it. 71 without knowledge of a medical or surgical alternative and without having access to information regarding the pros and cons of each, a patient obviously has few if any tools with which to form a therapeutic alliance with a physician or even enter into a meaningful treatment dialogue with that physician. 72 while the physician avoids conflicts with his or her patient, this veil of silence often robs the. patient of the right to self-determination, all under the guise of medical paternalism. 73 whenever a treatment is labeled futile, it is exempted from the requirement of discussion. thus the label itself "becomes a very powerful tool for relieving physicians of the requirement to 65. id. 66. id. at 58. 67. id. 68. susanm. wolf, conflictbetweendoctorandpatient, 161 l.med.&healthcare 197, 198 (1988). 69. id. 70. id. 71. id. 72. ld. at 198. see generally josephm. jacob, doctors and ruu!s (1988). 73. see generally au.ene. buchanan & danw. brock, deciding for others: the ethics of surrogate decisionmaking (1989). 122 indiana health law review [vol. 1:109 talk with their patient. the label marks off. a realm in which it is argued that the requirement does not apply ."74 c. uninsurable treatment options the results of an interesting and disturbing 1988 survey, supported by the american medical association's institute for ethics and drawn from a random sample of l,l24licensed united states physicians, were published recently?5 sixty-four percent responded (720 physicians)/6 respondent physicians empirically validated the belief that physicians are uneasy in describing medically indicated care not covered by insurance.77 because of restrictions in various health plans, useful patient care was sometimes not offered by thirty-one percent of the reporting physicians in the survey. 78 within this group thirty-five percent reported, additionally, that this course of action is more common today than it was five years ago.79 on the other hand, sixty-nine percent of the physician-respondents stated that they rarely or never followed this practice.80 one ethical rationale for not offering useful services not covered by insurance is physician discomfort over requests by patients to game the system, or, in other words, manipulate and deceive third party payers in their health plans. 81 inasmuch as the vast majority of physicians believe such patient requests are unethical, some might avoid such tense encounters by electing not to offer useful but uncovered services. 82 other reasons proffered for refusing health care infonnation include, rather paternistically, the compassionate desire not to raise levels of expecta­ tion, especially for medicaid or other economically impoverished patients who have medical coverage restrictions. in other words, "why offer a useful medical service to someone who cannot afford it?"83 financial pressures on physicians are also seen as a significant determinant in decisions to withhold treatment information. for physicians 74. wolf, supra note 68, at 199. see generally george p. smith, ll, utility and the principle of medical futility: safeguarding autonomy and the prohibition against cruel and unusual punishment, 12 j. contemp. health l. & pol'y 1 (1996). 75. matthew k. wynia et al., do physicians not offer useful services because of coverage restrictions, 22 healthaff. 190, 191 (2003). 76./d. 77. ld. at 194. 78. ld. at 193. 79./d. 80./d. 81. wynia et al., supra note 75, at 194. 82./d. 83. id. at 194-95. see also hallet al., supra note 6, at 191. 2004] vagaries of informed consent 123 with "more than 25 percent of income at risk'• for patient care costs. the trend is to neglect to offer patients optimal but uncovered services. 84 sadly. the results of this study parallel-and. indeed. revive-earlier institutional concerns over gag clauses in managed care programs. in the late 1990s, these provisions were thought of as prohibiting physicians, by contract. from discussing with their patients medical service options which were not covered in their health plans. 85 . adding significantly to present patient mistrust of the medical profession, this 1998 survey confirms the fact that gagging continues, not by contract, necessarily, but for other reasons as noted, all.of which have the ultimate effect of compromising the very doctrine of informed consent. 86 the pivotal ethical concern, then, is: "to what degree is it possible, and a professional obligation, for physicians to try to explain to their patients why some useful services are not coveredt'87 ill. informed decision-making and negotiated consent although it is seen that the foundation of informed consent is now well embedded in both the legal and medical arenas, negotiated consent is far from being as widely accepted. in fact, the ideal of negotiated consent is only beginning to emerge as a viable alternative to the traditional informed consent standard, particularly with application to healthcare for the elderly. the informed consent standard, which is based upon autonomy, emerged from the acute care environment and from a narrowly conceived view of the relationship between professional caregivers (physicians) and those dependent upon them (patients).88 similarly, the concept of negotiated consent recognizes the ideal of autonomy, yet in a more limited fashion. 89 negotiated consent recognizes the need for some version of "autonomy respecting paternalism" in the environment of long-term care, particularly involving elderly patients.90 fundamentally, paternalistic .interventions that serve to 84. wynia et al., supra note 75, it 194-95. 85. /d. at 196. 86./d. 81./d. 88. moody, supra note 24, at 64. see brian f. hofland, autonomy in long term care: baclcground /ssua and a progr(mrmatic response, 28 gerontolooist 3, 4 (1988) (observing tbat "patient ..• autonomy is not a value indigenous to medical contexts. but one imported into medicine from extrinsic social agendas such as tbat of constitutional law and the evolution of individual rights''). see also dwoddn, supra note 8, at 737 (challenging the view tbat autonomy should be the dominant value in medical law and ethics). 89. moody, supra note 24, at 64. 90. /d. (quoting donald v andevbbr, paternaustic intervention: the moral bounds on benevoi..ence (1986)). su generally vandeveer supra. 124 indiana health law review [vol. 1:109 enhance autonomy and allow patients to decide and act in keeping with their own values compose the underpinnings of negotiated consent.91 a. working principles in light of the unique issues and moral dilemmas involved in long-term care for the elderly, the interactions between patients and practitioners are primarily acute transactions.92 as such, enhancing the autonomy among patients of long-term care facilities is an extraordinarily difficult task. 93 the conditions at hand are very different from those encountered outside of residential care facilities, where informed consent is the prevalent model.94 recognizing these differences, negotiated consent attempts to address the various concerns involved and balance the involved parties' competing interests.95 under the negotiated consent standard, many legitimate views must be considered involving the patient, family, and institution. 96 the results are shared or dispersed authority for decision-making in which no single party has the exclusive power of decision97 and a nonalgorithmic process whereby negotiation is not governed by strict deductive rules.98 instead, negotiation is "more heuristic in its cognitive style, implying less reliance on codes of ethics and more attention to opportunities for discussion .... "99 even in those instances in which the ideal outcome is not attainable, a common situation among the frail elderly, negotiation serves to make the best of a bad situation."100 in order to implement effectively negotiated consent, there must be active participation by the patient or the patient's surrogate and consultation with all parties holding an interest in the decision. 101 furthermore, the patient must have at least a cursory knowledge of legal and ethical rights and the 91. moody, supra note 24, at 64. 92. id. 93. see harry r. moody, ethical dilemmas of nursing home placement, 11 genera· tions 16-23 (1987). the difficulties are heightened by professional interventions that verge on being more social than medical (e.g., eating, bathing, exercise), the patients' need for a degree of regimentation in their lifestyles, and the continuous fluctuation in competency or decisional capacity of the patients. see also moody, supra note 24, at 64-65. 94. moody, supra note 24, at 65. 95. id. 96. !d. at 67. 97. !d. instead, negotiated consent proposes the structure of a team decision-making pro­ cess, allowing for greater influence and more effective communication. id. 98. id. 99. moody, supra note 24, at 67. 100. id. 101. id. the notion exists, particularly with elderly patients, that a patient ought to be aware that negotiations are underway. furthermore, the patient should know which parties are active participants in the negotiation process, and, ultimately, any decision derived should be presented in such a manner as to be publicly defensible on a wide-scale basis. id. at 68. 2004] vagaries of informed consent 125 "opportunity for scrutiny and enforcement of those rights through some outside, higher authority .... " 102 in addition, the element of power in the deliberative process plays an integral part of the negotiated consent formula.103 obviously, little chance for negotiation exists if one party has such superior power as to leave the other party with no chance for deliberation. 104 by the same token, negotiated consent does not insist on absolute equality between the parties, either. 105 instead, the doctrine essentially supports the concept of "shared decision-making" between the physician and patient in those situations in which it is possible. 106 although the ideals of virtue and compassion called for in negotiated consent may be sophistic, they are by no means quixotic. the introduction of negotiated consent in health care for the elderly is designed primarily to urge a different set of ideals and emphasize that practitioners must demonstrate virtues alongside the purported rights a patient is assumed to possess. 107 b. new directions in american society, individuals who reach the age of majority are permitted a broad range of choice.108 they may choose their jobs, their relationships, and the patterns by which they live. 109 these rights of choice, however, are often denied to elderly persons because they are unable to effectuate preference without assistance.110 on november 1, 2002, the united states census bureau estimated one in every eight americans (roughly, 12.3% of the total population) was sixty­ five years of age and over-drawn as such from a total figure of 34.9 million in this age group.111 the american hospital association has determined that a 7.9% increase in hospitalization occurs whenever there is a 10% increase in 102. ld. at67. 103. ld. 104. moody, supra note 24, at 68. 105. /d. although the physician's base of experience endows physicians with greater facili­ ties to reason more accurately about medical issues than can their patients, the patient has the option of non-compliance and thereby retains an element of power for himself. id. see also schneider, supra note 5, at 110. 106. seemoody,supranote24,at68(citingunitedstates,president'scomm.forthe study of ethical problems in med. & biomedical & behavioral research, making health care decisions: a report on the ethical and legal impucations of informed consent in the patient-practitioner relationship (1982)). 107. moody, supra note 24, at 69. 108. nancy n. dubler, the dependent elderly: legal rights and responsibilities in agent custody, in ethical dimensions of geriatric care 137 (stuart f. spieker et al. eds., 1987). 109. ld. 110. id. 111. u.s. census bureau, resident population estimates of the united states by age and sex: april], 1990tojuly 1, 1999, withshort-termprojectionstonovember 1, 2000,available at http://www .census.gov/populationlestimates/nationlintfile2-l.txt (last visited feb. l, 2004 ). 126 indiana health law review [vol. 1:109 the number of seniors.112 thus, it is predicted that a majority of hospital services, 51% of inpatient admissions and 59% of beds, will be given over to the elderly by 2027. 113 by 2030, it is predicted this very group will top seventy million people, meaning about one out of every five americans will be included.u4 as the population of aging citizens grows, so does the need for such citizens to make pivotal decisions regarding their medical treatment.115 reality dictates that the capacity of elderly patients to make such decisions is often impaired by a higher incidence and prevalence of chronic brain disease,116 coupled with the burden of coping with numerous other medical afflictions. moreover, the risk for elderly patients may be compounded because they are more likely to be excluded from the medical decision-making process as a result of reduced physician contact, ageism, and paternalism. 117 even for the elderly patient, informed consent for medical decision­ making has been the standard consent practice in the medical community for a number of years.118 however, for the elderly, this process has failed in a number of areas, one of which is the issue of a patient's competence to consent to treatment. 119 thus, with the doctrine of negotiated consent as an alternative to the traditional model of informed consent, the needs and desires of elderly patients ideally have a greater chance ofbeing addressed adequately and equitably. dependent elderly persons pose a special problem for healthcare professionals in that their decisions often require the involvement of helpers and facilitators. 120 such involvement may result in differing standards of judgment and measures of worth being applied to an elder's individual choice. 121 the results are conflicting value systems that often reflect the competing concerns of institutional and individual self-protection and 112. laura b. benko, boomer bust?, modern healthcare, july 28, 2003, at 24. 113. /d. see also l.j. fitten & m.s. waite, impact of medical hospitalization on treat· ment decision-making in the elderly, 150 archives internal men. 1717 (1990). see gener· ally james lubitz et al., health, life expectancy, and health care spending among the elderly, 349 new eng. j. med. 1048 (2003). 114. betty booker, nursing-home costs soar; local prices average $64,000 annually, rich. times dispatch, aug. 7, 2003, atal. lls. fitten & waite, supra note 113, at 1717. 116. see id. see also emre kokmen et al., epidemiologic patterns and clinical features of dementia in a defined u.s. population, los transactions. am. neurological ass'n. 334-36 (1980); w.a. rocco et al., the epidemiology of dementia. 19 ann. neurology 415, 415-24 (1986). 117. fitten & waite, supra note 113, at 1717. 118. seeid. 119. see id. 120. dubler, supra note 108, at 137. see generally lj. fitten et al., assessing treatment decision-making capacity in elderly nursing home residents, 38 j. am. geriatrics soc'y 1097 (1990). 121. dubler, supra note 108, at 137. 2004] vagaries of informed consent 127 convenience. 122 in the end, the elderly person is at a great risk of losing the right to decide the course and conduct of his or her life.123 in such a scenario, the model of negotiated consent provides a realistic and viable means by which the interests of all parties involved may be represented. negotiated consent allows for the interaction of all affected parties, including the patient, family, clergy, and physicians.124 this process assures the presentation of a multitude of differing views while, ideally, preserving the values of the patient. the process of negotiated consent also combats another weakness of the traditional informed consent doctrine. commonly, informed consent can provoke anxiety and evoke previous experiences, fantasies, and associations for a patient, triggering an occasional primitive defense response. 125 with negotiated consent, the interaction of the parties and the commitment to shared dialogue should reduce the likelihood of such a response, if not completely eliminate it. a further deficiency of the informed consent model, as applied to older patients, is their inability to comprehend the specific elements of informed consent information. 126 thus, as a group, geriatric patients may have some impairment in providing their informed consent with regard to medical procedures. 127 because the process of negotiated consent involves, among other things, the friends and family of the patient, it is likely that a greater sense of trust exists among the parties, particularly if the patient needs assistance to comprehend fully the intricacies of the specific consent. however, the doctrine of negotiated consent is certainly not without its shortcomings. first of all, self-determination for long-term care residents is a valid ideal; however, it requires opportunity, capacity, and motivation on their part.128 although the opportunity and capacity factors receive a majority of the attention within the medical community, the motivational factor must be addressed seriously, particularly with elderly persons.129 if elderly patients 122. ld. 123. id. 124. moody, supra note 24, at 67. see also dworkin. supra note 8, at 737 (arguing for a "full social impact calculus" in the decision-making process). 125. j.p. hess et al., some psychological and legal considerations in the determination of incompetence in the elderly, 7 med. l. 151, 153 (1988). 126. b. stanley et al., the elderly patient and informed consent, 252 jama 1302, 1305 (1984). 127. id. the study revealed that, in comparison to their younger counterparts, older patients did show poorer comprehension, yet, generally seemed to make equally reasonable decisions. ld. thus, significant adverse effects were not noted until the ability to comprehend was considered severely impaired, as in the case of severe senile dementia. ld. 128. moody, supra note 24, at 69. 129. ld. moody points out that, especially with elder patients, it is possible to provide opportunities and to safeguard rights, but without motivation, patients will derive no benefits from these acts. ld. it is essentially a patient's own h'berty that he or she must exercise in order to take advantage of the opportunities that are available. ld. 128 indiana health law review [vol. 1:109 are not sufficiently motivated to exercise the rights being secured for them, the doctrine of negotiated consent serves no additional benefit for the patients. moreover, entertaining the multitude of opinions necessary for negotiated consent may require an overly burdensome and time-consuming recording process, and could even result in an invitation to litigation should the parties to the negotiation decide later that they are dissatisfied with the outcome.130 although perhaps a valid criticism, recording the outcome of the negotiation is obligatory for the process of negotiated consent to remain valid. 131 n. conclusions perhaps it is a correct assessment that no meaningful collaboration or hoped-for therapeutic alliance can be achieved between doctor and patient until physicians treat patients as adults and not children; learn that there is a real distinction between the physician's ideas of best treatment and those which are seen as best by their patients; and, furthermore, learn how to acknowledge their own ignorance in diagnosis, as well as treatment and prog­ nosis. acting in such a manner will allow the patients to better understand the inherent uncertainties in both the art and science of medicine which, in turn, give rise to valid differences of belief based upon clinical experience. 132 sadly, all too often, the quest for diagnosis and cure, or what has been termed "the riddle," seduces many physicians and forces them to ignore the realities of pathological processes. 133 in projecting the future of health care for the elderly, the standard of negotiated consent is undoubtedly a more desirable standard to implement for all parties involved than the traditional informed consent despite the assault on its viability, the imperative of negotiated consent focuses ultimately on the concept of "keep listening" as opposed to "keep talking."134 this goal, even though often times difficult to achieve, may provide the elderly patient with a stronger sense of participation in the direction of his or her medical treat­ ment and, hopefully, with a greater sense of trust and confidence, allow the "ethics of intimacy rather than the ethics of strangers [to] ... take root and flourish."135 seen as a normative value rather then an empirical constant, 136 perhaps, in reality, the consequences of the doctrine of informed consent are of less 130. id. at 68. 131. see id. a basic example of what should be recorded is as follows: "family talked it over and decided in favor of trying the new treatment patient agreed it was best." moody, supra note 24, at 68. 132. jaykatz, thesilentworidofdoctorandpatientxi(1986). 133. sherwin b. nuland, how we dm: refi..octions on life's final chapter 249, 265 (1994). 134. moody, supra note 24, at 70. 135. ld. at69. see generallyharryrmoody,ethicsin anagingsociety(l992). 136. schuck, supra note 17, at 932. 2004] vagaries of informed consent 129 importance than the values its seeks to promote.137 to be sure, the doctrine needs to be contextualized both procedurally and substantively in legal doctrine.138 setting new dialogic responsibilities for physicians, however, may not succeed in strengthening the process. 139 indeed, in the present cost­ conscious health care environment, such an imposition may only serve to further complicate its simple and direct mandate: namely, to provide a knowledgeable atmosphere for a therapeutic partnership or moral agency between physician and patient to occur. 140 in addition, without the doctrine of informed consent, there would be little opportunity to create an atmosphere in which-in health care delivery systems-both interdependence and inter­ relationship are acknowledged, professionally and legally, as practical norma­ tive values. 141 although the doctrine of informed consent will always remain a relative term, ''with the degree of completeness resting on so many variables including, of course, the nature and reliability of the source," it should be seen as more than an aspirational goal.142 rather, it can and indeed should serve as a useful construct for embedding the doctrine as an integral part of the ethos of medicine; 143 an ethos tied to a recognition of patient trust and partnership with the physician as the cornerstone of the healing enterprise144 which must always seek to provide "a right and good healing action in the interests of a particular patient."145 in the final analysis, however, it remains for the medical profession, not the legal profession, to formulate and effect a truly contemporary doctrine of informed consent, one, to be sure, that is responsive to the ''proddings of the law," but, more importantly, one that is cognizant of the very complex and nuanced interactions between patients and their physicians.146 137. /d. at 939. 138. /d. at 951. 139. id. at 935. 140. pellegrino, human person, supra note 1; pellegrino, autonomy, supra note 1; pellegrino, reconstruction, supra note 2, at 74. 141. gayun &jennings, supra note 1, at 243. 142. jeffrey s. tobias, contemporary challenges in clinical research: paying lip service to informed consent, or a genuine shift of gear?, in informedconsenrinmbdical research, supra note 15, at 318-19. 143. katz, supra note 18, at 91 (arguing that until the doctrine becomes an integral aspect of the ethos of medicine, it is condemned to remain a fairy tale). 144. see generauy edmund d. pellegrino & john l. harvey, whom should the patient trust?, am., oct. 1, 2001, at 19. 145. pellegrino, reconstruction, supra note 2, at 47. 146. katz, supra note 18, at 71. see generally katz, supra note 132. richard 0. dolinar a private practice clinical endocrinologist in phoenix, arizona, dr. dolinar earned his medical degree from the state university ofnew york at buffalo and did his endocrinology fellowship at duke university. dr. dolinar has testified before the u.s. senate subcommittee on consumer affairs and has also given congressional briefings on capitol hill regarding healthcare issues. he represented the american association of clinical endocrinologists ("aace") at the public hearings regarding the medicare modernization act of 2003 and the medicare drug benefit. he has also presented to state legislators as well as various · healthcare industry professionals. dr. dolinar has been interviewed by both the local and national media, including cnn, cbs and pbs regarding his opinions on healthcare issues. a published author, in both professional and consumer publications, his articles and opinion pieces have appeared in the wall street journal, usa today, the new york times, the new england journal ofmedicine, jama (journal of the american medical association) and diabetes research. his articles have also appeared on various web sites including the heritage foundation. he is co-author of the book, diabetes 101: a pure and simple guide for people who use insulin (1998). dr. dolinar is a member of the board ofdirectors of aace and serves on its national legislative and regulatory committee. he is the chair of its future of healthcare task force. dr. dolinar also serves as a senior fellow in healthcare policy at the heartland institute and has held leadership positions in other professional organizations including the juvenile diabetes research foundation and the american diabetes association. dr. dolinar served as a flight surgeon in the vietnam war and is a retired u.s. air force colonel. s. luke leillinger luke leininger is currently a student at both harvard business school, where he is completing his mba, and at harvard university's john f. kennedy school of government, where he is completing his mp a, with an emphasis in health policy. mr. leininger earned his bachelor's degree in economics from brigham young university in 2002. during the summer of2005, mr. leininger served as a health policy fellow at the heritage foundation, where he researched and wrote extensively on topics pertaining to physician compensation and medicare prescription drug coverage. prior to attending graduate school, he was an associate in the pharmaceuticals practice of the economic consulting firm, charles river associates, where he designed pricing and contracting strategies for both branded and generic pharmaceutical products. in addition to these professional experiences, mr. leininger spent two years as a religious volunteer in romania, where he developed an interest in health care delivery in developing countries. heritage fonndatioa the heritage foundation is a research institute founded in 1973. its mission is to formulate and promote conservative public policies based on the principles of free enterprise, limited government, individual freedom, tradi­ tional american values and a strong national defense. members· of the heritage foundation conduct research on numerous domestic and international topics. their focus is to provide timely articles on important issues currently facing the american public. the completed research projects from the heritage foundation are used to develop and influence public policy. more information about the heritage foundation and other on-line articles written by nationally recognized contributors focused on important national topics may be obtained at the heritage foundation's website: http://www.heritage.org. pay for performance or compliance? a second opinion on medicare reimbursement richard dolinar s. luke leininger nothing in this title shall be construed to authorize any federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person. social security act1 there is good news and bad news on medicare reimbursement. the good news is that members of congress are unhappy with the medicare physician payment program that they created. it is a complex system of administered pricing and price controls, governed by elaborate statutory formulas and characterized by mind-numbing regulatory micromanagement. in sharp contrast to reimbursement for professional services in other economic sectors, medicare providers are not paid according to their skill levels, their innovative treatments, the quality of the care delivered to individual medicare patients, or the specific benefits provided to patients. moreover, under current government formulas, they can look forward to future reductions in medicare reimbursement even though they are expected to treat a dramatically larger medicare population. needless to say, most physicians are unhappy with medicare's payment system-a view increasingly shared by senior members of congress. house ways and means committee chairman bill thomas (r-ca) and health subcommittee chairman nancy johnson (r...ct) have said, "it is time to change this irrational system. "2 the bad news is that, instead of enacting real reform, congress is preparing not only to keep medicare's rigid system of price controls and central planning, but also to add another layer of regulatory control over physician behavior. senate finance committee chairman charles grassley (r-ia) and ranking member max baucus (d-mt) sponsored the medicare 1. 42 u.s.c. § 1395 (2006). 2. reps. thomas, johnson ask for cms help in changing medicare's "irrational" payment system, wash. health pol'y week in rev., june 27, 2005, available at http://www.cmwf.org/healthpolicyweek! (last visited may 19, 2006). 398 indiana health law review [vol. 3:391 value purchasing act of2005 (s. 1356_>3, which would implement ''pay for performance" in ·the medicare program by tying physician payment to compliance with government-defined medical guidelines. representative johnson introduced ·a· similar bill in the house. the approach is well intentioned, but more central planning will only intensify the medicare reimbursement problem, not ameliorate it. i. a misguided approach the ·concept of ''pay for performance" in medicare is unquestionably attractive to federal policymakers and suggests-correctly in our view-that medicare patients and the taxpayers are not getting the best value for their money. using the rhetoric of"best practices" and "evidence-based medicine" to describe this approach, proponents are creating the false impression that new government guidelines would promote market-like competition, control costs, and improve the quality ofhealth care delivered within medicare. they believe that adopting this approach would simultaneously control the growth of medicare costs in a more rational fashion and close the gap "between the health care we now have and the health care we could have.'>4 before succumbing to the latest health care policy fad, members of congress should carefully consider two things: the likely impact of government incentives designed to secure physician adherence to centrally determined standards and whether or not those standards can indeed provide higher quality to patients and better value to taxpayers. despite the rhetoric to the contrary, this proposal is anything but a free-market approach to physician payment. it is, in fact, a compliance-based system, inherently burdened by serious limitations. for example, such a system would: • dump patients into a system of top-down, "cookbook'' medicine that is incompatible with high professional standards of patient care; • spawn an increasing number of medicare rules, regulations, and guidelines, furtherundercuttingthephysician's professional auto­ nomy and integrity, as well as patient choice and access to care; • undermine the more desirable goal ofhigh quality, which requires personalized care; • retard medical innovation and introduce unproductive gaming by doctors to secure higher medicare reimbursement; and • further weaken the traditional doctor-patient relationship. 3. senator chuck grassley, statement upon introduction of the medicare value purchasing act of2005 (june 30, 2005), at http://www .himss.org/content/files/medicare6-3005_floor_statementpdf(last visited may 19, 2006). 4. inst. of med., crossing nm quaijty chasm: a new realm system for nib 21stcen1ury (2001) [hereinafter crossing nib quality chasm). 2006] pay for performance or compliance? 399 ii. a beiter policy if members of congress had seized the opportunity to replace the current medicare system with a premium support program similar to the federal employees health benefits program ("fehbp") during consideration of the medicare modernization act of 2003, they would not now need to fix the medicare physician payment system that they created. the fehbp is characterized by consumer choice, market competition, and minimal bureaucracy and regulation. the office of personnel management, which administers the fehbp, does not prescribe detailed formulas for physician payment for thousands of medical services, enforce price controls, or conduct compliance audits or investigations into physician payment. however, short of serious and comprehensive medicare reform, congress should go back to the drawing board and design a new reimburse­ ment system for medicare doctors, combined with reliable market-based updates for physicians' services. meanwhile, congress should: • abolish the current fee schedules and the update formulas; • eliminate medicare restrictions on balance billing (effectively a price control system) and allow doctors to charge either more or less than the medicare fixed price for medical services; and • require physicians, as a condition of participating in medicare, to disclose the prices that they charge for medicare services. as a national market develops, private-sector organizations (e.g., consumer, professional, and seniors' groups) could generate information on the quality of health care services, meeting the market demand for quality information. ill. the current medicare reimbursement system medicare's current reimbursement policy is a complex, formula-driven system of administrative pricing, central planning, and price controls.5 it has 5. since the early 1980s, congress has tried repeatedly to solve the growing problem of rapidly rising medicare expenditures by imposing complicated and progressively tighter systems of administrative pricing for hospital and physician services. in 1983, with the support of the reagan administration, congress adopted a progpective payment system ("pps") for medicare payment to hospitals, fixing the prices of hospital services according to the average cost of treating specified diagnoses. in 1989, congress created the rbrvs system for physician reimbursement. in 1997, congress expanded the pps system for a variety of non-physician medicare providers. see generally ctrs. for medicare & medicaid servs., http://www.cms.hhs.gov/ (last visited may 20, 2006). 400 indiana health law review [vol. 3:391 · three main features: the fee schedule, updates and controls, and balance billing restrictions. a. the rbrvs fee schedule6 medicare uses thetesource-basedrelative value scale (''rbrvs") to pay for physician services. under this formula. medicare officials compute the "objective value" of an estimated 7,000 procedures.7 each component of a medical service is assigned a weighted value that is calculated by using social science measurements of the time, energy, and effort required to perform a given procedure, including resource inputs such as medical equipment. malpractice insurance, and administrative costs. these weighted "values•• are then converted into dollar amounts and used to determine the. fees that medicare pays to physicians for those services.8 the diagnosis related group ("drg") system reimburses hospitals using a similar strategy. 9 b. updates and controls attempting to limit medicare physician costs, congress also created volume controls, based on an official projection of the "appropriate" growth rate of medicare physician services. since 1997, these volume controls have been tied to the sustainable growth rate ("sgr"), the congressionally created formula for determining annual updates in physician reimbursement rates under the medicare fee schedules. under the sgr, the annual update in reimbursement is linked to· the aggregate level of medicare spending for physician services. if spending exceeds the government target, which is based 6. altogether, medicare use8 eleven different fee schedules and pps arrangements to establish the prices paid to over one million providers for treating medicare patients. letter from the ctrs. for medicare and medicaid servs. adm'r mark mcclellan, to the house ways and means comm. chairman wllliam thomas (june 24, 2005) (on file with author). 7. for more information about the rbrvs, see kevin hayes, medicare's payments for physician services, medicare payment advisory comm'n (medpac) (feb. 14, 2003), at http://www.medpac.gov/publicationsfcongressional_reports/physicians_kh.pdf (last visited may 19, 2006). for a critical evaluation of the rbrvs, see robert e. moffit, back to the future: medicare's resurrection of the labor theory of value, is reo. 54, 54-63 (1992), availab/eathttp:/lwww.cato.~onlreglsn4f.html(lastvisitedmay 19, 2006). see also regulating doctors' fees: compbtmon,benefitsandconi'rolsundbrmedicare (h.e. frech iii, ed., 1991 ). 8. robert e. moffit, why doctors he abandoning medicare and what should be done about it, heritage found. backgrounder no. 1539, apr. 22, 2002, at 5, available at http://www.heritage.orgiresearch/healtbcare/bg1539.cfin (last visited may 19, 2006). 9. for more information about the drg hospital payment system, see medicare payment advisory comm'n, rep. to congress: medicare payment poucy, at 43-44 (mar. 2005), available at http://www.medpac.gov/publications (follow "more publication" hyperlink; then follow "reports" hyperlink) (last visited may 19, 2006). 2006] pay for performance or compliance? 401 on growth in the national economy, a statutory algorithm reduces the increases in the reimbursement rate. the sgr system has been ineffective in controlling volume--the volume of physician services per beneficiary rose by almost twenty-two percent between 1999 and 200310 -while creating new problems for physician reimbursement. the centers for medicare and medicaid services ("cms") recently reported that medicare's sharp 15.2% increase in spending for physician services in 2004 was due almost entirely to volume growth. the result was a scheduled 4.3% cut in physician reimbursement rates, beginning january 1, 2006.u cms actuaries are projecting similar negative payment updates of five percent annually for the next seven years, which means that physician payments would decrease by more than thirty-one percent from 2005 to 2012. during the same period, physician practice costs would go up by nineteen percent. 12 as doctors find it financially burdensome to treat medicare patients, they will stop accepting new ones. according to a recent american medical association survey, thirty-eight percent of physicians will reduce the number of new medicare patients that they see as a result of the impending 2006 cuts.13 more than one-fifth ofmedicare enrollees already have trouble finding a primary care physician, and twenty-seven percent report delays in getting an appointment, according to a recent medicare payment advisory commission ("medp ac") study. 14 there are several reasons for the sgr' s inability to control volume. for one, the growth rate of the national economy (as measured by gdp) has very little to do with the growth rate of services, making it a poor benchmark for a spending target. for example, during a recession, the spending target is pushed downward, punishing physicians, even though practice costs and demand for services do not drop proportionally. in fact, the growth in medicare spending is driven largely by new technology, patient needs, and public policies related to the provision of services. these factors are outside the direct control of physicians, making them useless targets for volume control incentives. 10. id. 11. medicare payment advisory comm'n, issues in a modernized medicare program, atl98 (june 2005), available athttp://www.medpac.gov/publications (follow "more publication" hyperlink; then follow "reports" hyperlink) (last visited may 19, 2006). 12. letter from william thomas, house ways and means comm. chairman and nancy l. johnson, chairman, subcomm. on health, to ctrs. medicare and medicaid servs. adm'r mark mcclellan (july 12, 2005) (on tile with author). 13. am. med. ass'n, ama member connect survey: medicare payment cuts will hurt access to care, http://www.ama-assn.org/ama/publcategory/i4925.html (last visited may 19, 2006). 14. am. med. ass'n, medicare physician payment: the facts, http://www.ama­ assn.org/amal/pub/uploadlmm/399/nac _ppfacts.pdf (last visited may 19, 2006). 402 indiana heal1h law review [vol. 3:391 moreover, even if physicians did exert a large degree of control over medicare spending, individual doctors cannot be expected to respond to collective incentives. an aggregate spending target and universally applied rate update will not decrease (and may even increase) the short-run incentives for individual physicians to increase volume, because they know that any personal effort to reduce services would not result in a proportional increase in payments.15 c. balance-billing restrictions the third feature of medicare's current reimbursement policy is the restriction on balance billing, the amount charged by a provider to a patient above what medicare is willing to reimburse. with the enactment of the balanced budget act of 1997, congress imposed new legal obstacles to private contracts for services performed on medicare recipients, cutting off an escape route for doctors and patients who might want to enter into a private payment system outside the medicare program. 16 meanwhile, providers must incur losses because of inadequate reimbursement for medicare services17, and they do not have the flexibility to adjust prices to attract new business or react to market challenges and opportunities. by removing any remnant of a price mechanism, balance-billing restrictions compound the inefficiencies of the medicare physician payment system and stifle improvements in quality and value. in summacy, medicare pays doctors according to a resource-based formula that embodies. an "objective" theory of value that is utterly inconsistent with modern economics, combined with inefficient price regulation and an illogical reimbursement update formula. the current medicare fee schedule does not and cannot account for differences in physicians' skills, quality of service, and benefit to the patient any more than a physician can account for the state of the national economy. while common sense would dictate abolishing this outdated approach in favor of a rational system of market pricing, congress is instead preparing to impose another layer of regulatory compliance on physicians. 15. moffit, supra note 8, at 5-6. 16. under the terms ofsection 4507 of the balanced budget act ofl997, any doctor who enters into a private contract with a medicare enrollee to provide services outside of the medicare system is prohibited fiom billing medicare for two years for any patients. since 1997, the terms and conditions of these relationships have been further codified through regulation and litigation. for an excellent overview of this issue, see johns. hoff, medicare private contracting: paternausm or autonomy? (1998). 17. david glendinning, ama to write balance-billing legislation, am. med. ass'n news, july 11, 200s.available at hup:/lwww.ama-assn.org/amednews (subscription required) (last visited may 20, 2006). 2006] pay for performance or compuance? 403 n. the genesis of pay-for-performance reimbursement health policy experts who advocate pay for performance in provider reimbursement invariably rely on the concept of evidence-based medicine ("ebm"). originally developed in the 1970s and 1980s by clinical epidemiologists at mcmaster university in canada, ebm is an attempt to apply epidemiological principles to clinical care and promote reliance on research data, particularly randomized controlled trials ("rcts"), in the practice ofmedicine.18 in a performance-based reimbursement system, ebm is used to develop ''clinical practice guidelines'' and compensate health care providers according to their compliance with the ''best practices" dictated by a third party's interpretation of rcts. health maintenance organizations ("hmos'') seized upon this concept in the 1990s, employing strict practice rules to override the clinical judgment of the treating physician in order to control utilization and limit costs. in practice, they used guidelines to rule instead of to guide, stressing evidence-based guidelines to the exclusion of clinical judgment. despite provoking a backlash from physicians and patients during the mid to late 1990s, practice guidelines continued to be developed for physician practice at a rapid rate. according to one estimate, more than 1,000 guidelines are being developed annually by quality-of-care organit.ations, medical associations, and health insurance plans.19 those who advocate tying clinical guidelines to financial compensation through pay-for-performance reimbursement claim that it will narrow the gap between "ideal," cost-effective care and ·actual care observed in clinical settings. in their view, financial teeth are needed to motivate physicians to standardize their treatment decisions. they believe that this would reduce medical errors, optimize quality of care, and control escalating health care costs by controlling price and utilization more directly.20 a. enter medicare the centers for medicare and medicaid services obtained the authority to experiment with pay for performance in medicare from the medicare modernization act of2003 and the medicare, medicaid, and schip benefits 18. r. brian haynes, what kind of evidence is it that evidence-b03ed medicine advocates want health care providers and consumers to pay attention to?, 2 bmc health servs. res. 3 (mar. 6, 2002), at http://www.biomedcentral.com/1472-6963/2/3 (last visited may 20, 2006). 19. stefan timmermans & aaron mauck, the promise$ and pitfalls ofevidence-b03ed medicine, 24(1) healthaff. 18, 19 (2005). 20. crossing the quauiychasm, supra note 4; nat'l comm. for quality assurance, the state of health care quality: 2004, at http://www.ncqa.orglcommunications/somc/ sohc2004.pdf (last visited may 20, 2006). 404 indiana heallll law review [vol. 3:391 improvement and protection act of2000.21 the agency has established eight demonstration initiatives: two address the quality of clinical care in hospitals, three deal with physician offices and integrated health systems, and three test specific models of chronic care improvement and disease management.22 the premier hospital quality incentive (''phqf') demonstration, the most advanced initiative, is designed to track and reward performance in treating five chronic health conditions at 270 hospitals around the country.23 provider compliance with a uniform set of thirty-four quality indicators yields significant financial rewards for participating providers, and failure to follow them adequately leads to decreased compensation. while it will be several years before conclusions can be drawn from even this first demonstration, cms did release a round of tentative first-year results in may, showing an average increase in the composite quality score of participating hospitals from seventy-nine percent to eight-six percent.24 while seemingly impressive, however, these prehminary results do not constitute evidence of improved quality, but rather of increased compliance. the composite quality score is merely a measure of the percentage of the time that hospitals followed treatment instructions in pursuit. of a financial bonus. b. triumph of process although the score does contain two components, a process score and an outcome score, it is heavily weighted toward recommended processes, not outcomes. of the thirty-four quality indicators in the hospital demonstration, twenty-seven measure compliance with dictated processes, while only seven measure outcomes like mortality or readmission rates.25 the physician group practice demonstration, which began in april of this year and is the first major medicare pay.for-performance initiative to concentrate on physicians, similarly focuses on process over outcome. according to the demonstration design report, "the major focus of the 21. ctrs. for medicare and medicaid servs., medicare "pay for peiformance (p4p)" initiatives, http:/lwww.cms.hbs.gov/medialpresslrelease.asp?counter=1343 qast visited may 20,2006). 22. id 23. press release, ctrs. for medicare and medicaid servs., medicare pay-for-performance demonstration shows significant quality ofcare improvement at participating hospitals (may 3, 2005), at http://www.cms.hhs.gov/appslmedialpress/release.asp?counter= 1441 (last visited may 20, 2006). 24. ld this is the average of reported composite score improvements for each of the five chronic conditions, 25. outcomemeasuresrepresentonly50%ofthehipandkneereplacementscore,37.5% of the coronary artery bypass graft(cabg) score, i i% oftheacutemyocardial infarction (ami) score, and zero percent of the pneumonia and heart failure scores. ctrs. for medicare and medicaid servs., cms hqi demonstration project: composite quality score methodology overview, at http://www.cms.hhs.gov/hospitaiqualitylnits/downloadsihospitalcomposite qualityscoremethodologyoverview.pdfqast visited may 20, 2006). 2006] pay for performance or compliance? 405 demonstration will be on measuring process indicators of quality. they are the indicators most easily measured."26 they may be the most easily measured, but are they the most indicative of quality care? thus, despite the relative lack of objectivity and flexibility, medicare's demonstrations rely primarily on process mandates rather than outcome measures to implement pay for performance. david m. eddy, senior advisor for health policy and management at kaiser permanente, acknowledges that ••a process measure, by its very nature, micromanages. instead ofleaving plans free to set their own priorities for improving health outcomes, a process measure tells plans precisely what their priorities should be.'m even if outcomes were used exclusively, the process of choosing which outcomes to include and deciding the relative importance of each outcome would necessitate deference to the values, perspectives, and agenda of the policymaker. c. congressional action bipartisan congressional efforts are now underway to move medicare beyond demonstrations into a full-scale pay-for-performance reimbursement system. cms administrator mark mcclellan appears determined to move ahead with a medicare pay-for-performance expansion under the regulatory prerogatives ofhis agency. he is making the effort one ofhis top priorities and recently speculated that within the next five to ten years, performance-based compensation could comprise up to thirty percent of the government's payments to providers. 28 any national medicare pay-for-performance payment system will likely be similar to the cms demonstration initiatives, emphasizing process over outcome and rewarding compliance with centrally defined practice guidelines. preliminary reports indicate that the proposed legislation would pay for compliance-based bonuses by withholding up to two percent of regular reimbursements from all physicians. 29 in other words, most doctors would receive less so some could receive more. this· is not quality-based compensation; it is redistribution of income toward those providers who subordinate their judgment and creativity to the mandated protocols most successfully. 26. gregory c. pope et al., physician group practice (pgp) demonstration design report, at http://www .cms.hhs.gov/healthplans/research/pgpdemorpt.pdf (last visited aug. 30, 2005). 27. david m. eddy, peiformance measurement: problems and solutions, 17(4) health aff. 7, 18 (1998). 28. cal. healthcare found., pay-for-performance programs draw mixed reviews, http:l/www.ihealthbeat.orglindex.cfm?action=dspltem&itemid= 105722 (last visited may 20, 2006). 29. e-mail from renal physicians ass'n, to rpa members (july 15, 2005), at http://www.renalmd.orglblastemaivjulyos.html (last visited may 20, 2006). 406 indiana health law review [vol. 3:391 because of medicare's vast size, the change would reverberate throughout the private payer system, compounding its effect. with almost forty-two million enrollees and $290 billion in annual expenditures, which will dramatically increase in 2006 when the medicare part d drug entitlement takes effect, medicare is the largest purchaser ofhealth services in the united states.30 in an open letter published in health affairs, medicare pay-for­ performance advocates point out that .. a major initiative by medicare to pay for performance can be expected to stimulate similar efforts by private payers, just as medicare's adoption of prospective payment for hospitals did two decades ago."31 v. problems of the medicare pay-for-performance project before launching medicare into a pay-for-performance program, congress should consider the problems that will necessarily arise out of a medicare payment system that requires adherence to centrally defined protocols. congress cannot safely ignore these difficulties. a. problem #1: limitations ofevidence-based medicine the gold standard of evidence in evidence-based medicine is a combination of double-blind, randomized, controlled trials and a systematic review of medical studies called meta-analysis. although it is conceptually attractive because of its appeal to statistics, no evidence supports overriding the treating physician's medical decisions with rct-based guidelines issued by a third party who has never even seen the patient. in 2004, the agency for healthcare research and quality ("ahrq'') in the u.s. department ofhealth and human services reviewed the literature related to the efficacy ofebm­ based compensation, which it referred to as .. quality-based purchasing." the review found "only nine randomized controlled trials" and concluded that "little unequivocal data" supported this approach.32 the premise of rcts as objective verification of "best practice" encounters several other serious conceptual problems. first, rcts can conflict with one another. in july 2002, scientists conducting the women's health initiative found that preempro, a hormone replacement therapy drug, had risks ofheart attacks exceeding its benefits. these results directly contradicted the results of several other previous and ongoing rcts, which showed a reduced 30. henry j. kaiser family found., medicare at a glance, http://www.kff.org/medicare/ upload/7305.pdf(jast visited may 20, 2006). 31. berwick et al., payingfor peiformance: medicare should lead, 22(6) healthaff. 8, 10 (2003). 32. r.a. dudley et al., strategies to support quality-based purchasing: a review of the evidence, http://www.ahrq.gov/clinic!epcsums/qpurchsum.pdf(jast visited may 20, 2006). 2006] pay for performance or compliance? 407 risk of heart disease associated with the drug.33 according to dr. r. brian haynes, chief of the health information research unit at mcmaster university and one of the originators ofebm, "it is difficult to be smug about the superiority of the research methods advocated by ebm when the results of studies that are similar methodologically not infrequently disagree with one another."34 ebm's usefulness as the primary benchmark for treatment decisions is also questionable because rcts can address only limited medical issues. despite the massive amount of medical literature published every year, legitimate rcts cover only a small number of conditions and procedures. almost all are conducted over only a few months or years, leaving the long­ term consequences of a therapy undetected. 35 according to dr. nuala kenny, founder of the department of bioethics at dalhousie university in canada, "scientific data cannot be expected to guide most medical decisions directly. there are not enough randomized trials or epidemiologic studies."36 to develop guidelines, developers often must depend upon some studies conducted on relatively small and unrepresentative populations. as a result, explains dr. alan m. garber of stanford university's school ofmedicine, "guideline authors nearly always extrapolate to groups that were not adequately represented in the trials."37 interestingly, early proponents of evidence-based medicine understood its weaknesses and never meant for it to be more than one factor in a ''multi­ faceted clinical decision-making decision process."38 according to dr. haynes: fl. [e]vidence from research can be no more than one component of any clinical decision. other key components are the circumstances of the patient (as assessed through the expertise of the clinician) and the preferences of the patient. just how research evidence, clinical circumstances, and patients' wishes are to be combined to derive an optimal decision has not been clearly stated, except that clinical judgment and expertise are viewed as essential to success. 39 33. gina kolata, hormone studies: what went wrong?, n.y. times, apr. 22, 2003, at 34. haynes, supra note 18, at 5. 35. mary e. tinnetti et al., potential pitfalls of disease-specific guidelines for patients with multiple conditions, 351 new eng. j. med. 2870,2870..74 (2004). 36. nualap. kenny, does good science make good medicine?, 157 can.med.ass'n. j. 33, 34 (1997). 37. alan m. garber, evidence-based guidelines as a foundation for peiformance incentives, 24(1) hea.lm.aff. 174, 176 (2005). 38. aaron michael cohen et al., a categorization and analysis of the criticisms of evidence-based medicine, 73 int'lj. med.informatics 35, 35-43 (2004). . 39. haynes, supra note 18, at 4. 408 indiana heal. til law review [vol. 3:391 thus, research evidence is just one of three decision points in the treatment process. the other two, to which "applied research is a comple­ mentary way of knowing,'' are clinical circumstances and patient preferences.40 by using financial incentives to drive compliance with clinical algorithms, a medicare pay-for-performance scheme would devalue these two aspects of medical decisions in favor of a prescribed list of procedures. in other words, it would produce the very "cookbook medicine" that those who conceived of ebm have denounced as a "misuse of evidence based medicine. ""1 b. problem #2: dangers of replacing patient choice and physician autonomy with central planning as dr. david m. eddy has observed, "it is not stretching things too far to say that whoever controls practice policies controls medicine.'"'2 since clinical research produces conflicting, questionable, and limited evidence, the decisions required to reconcile results, assign relative importance, and sift out bad research cannot be made without subjective human judgment. ultimately, someone's values are reflected in treatment decisions, whether those values are those of the patient, the physician, or a third party. bias is inherent in such judgments. bias is found in the production, interpretation, and application of pay­ for-performance quality indicators. researchers exhibit bias when deciding which areas of research to pursue, which previous research to reference, and how to conduct their experiments. journal publishers exhibit bias when deciding which research to publish. published research is then subject to interpretation by guideline creators, who exhibit bias when choosing which research to incorporate in their guidelines, resolving conflicting results, assessing research flaws, and transforming findings into rules that weight competing priorities. according to a 2004 institute ofmedicinereport, "there are gaps and inconsistencies in the medical literature supporting one practice versus another, as well as biases based on the perspective of the authors, who may be specialists, general practitioners, payers, marketers, or public health officials.'"'3 unable to avoid bias, pay for performance cannot live up to the 40. ld. at3. 41. david l. sackett et al., evidence based medicine: what it is and what it lsn 't, 312 brit. med. j. 71, 71 (1996). 42. david m. eddy, clinical decision making: from theory to practice, practice policies-what are they?, 263 jama 877, 877-78 (2000). 43. patient safety: achieving anew standard for care 158 (philip aspden et al. eds., 2003). 2006] pay for performance or compliance? 409 standards of objectivity claimed by those who support imposing their version of"doing the right thing" on the medical community.44 members of congress need to ask themselves this crucial question: whose judgment and values do we want to control important decisions about our medical care? pay for performance would give control to third-party insurance or government managers, who have no information about the unique conditions, health history, preferences, and personal values of the individual patient being treated by the individual doctor. the protocols of the distant government agency would in practice overrule the doctor's medical judgment and the patient's choices. the impact of this control shift would be government micromanagement of medical care and a corresponding reduction in physician autonomy and patient choice.45 physicians would be compelled either to follow government treatment guidelines or to suffer financial consequences, regardless of whether a particular guideline is in the best interests of a particular patient. twila brase, president of the citizens council on health care, warns that adopting a pay-for-performance program "will lead to a limited list of approved health care services--'best practices' as determined by the agendas and values of a small cadre of politically motivated, personally-biased individuals sitting around a table somewhere making treatment decisions far from the patient's bedside.•>46 these "elite" decision makers would not even know the name of the patient, much less the patient's unique circumstances and values. when made from a distance by budget-focused technocrats, treatment decisions are apt to focus as much on rationing as they do on quality improvement. keith syrett, professor of law at the university of bristol, observes that "decision making by guideline offer[ s] a means of scientifically depoliticizing the rationing debate. "47 payers are able to create the impression that there is scientific legitimacy behind cost-based decisions to restrict patient access to medically necessary treatments. 44. the third of five system strategies listed on cms's quality improvement roadmap, published in july 2005, explains the agency's intention to "pay in a way that expresses our commitment to supporting providers and practitioners for doing the right thing." ctrs. for medicare and medicaid servs, quality improvement roadmap, http://www.cms.hhs.gov/ councilontechlnnov/downloads/qualityroadmap.pdf (last visited may 20, 2006). 45. americans overwhelmingly prefer control of medical care to lie with themselves and their physicians. this was demonstrated in the fight over president clinton's health security act in 1993, which included, among other things, required clinical guidelines to manage utilization. 46. twilabrase, how technocrats are taking over the practice of medicine: a wake-up call to the american people, citizens' councll.. on heallh care pol'y rep. 18 (2005), avai/ab/eathttp:j/www.cchconline.orgfpdfreport/ebm_report_-_ex_summary.pdf(lastvisited may 20, 2006). 47. keith syrett, a technocratic fix to the "legitimacy problem"? the blair government and health care rationing in the united kingdom, 28 j. heallh pol., pol'y l. 715, 728 (2003). 410 indiana health law review [vol. 3:391 the american medical association ("ama") expressed concern over such potential ebm-based rationing at its national meeting in june 2005. "there is a potential concern when there is another intent behind pay for performance," said ama trustee john armstrong, m.d.48 "some so-called pay-for-performance programs are a lose/lose proposition for patients and their physicians, with the only benefit accruing to health insurers.'o49 as with any health care system that employs top-down planning to ration health care, the ultimate effect will be to limit access to appropriate health care services according to priorities imposed by a centralized bureaucracy. this should be considered in the context of medical malpractice. it is bad policy to empower a centralized bureaucracy to construct and determine which clinical algorithms are to be used and which practices are "best" while also excusing it from any "responsibility for the clinical consequences."50 in reality, the ultimate responsibility remains with the treating physician, whose best medical judgment may dictate proceeding in one direction while the third­ party algorithm forces the physician to go in another. this could produce adverse results for the patient, and it would further complicate the medical malpractice crisis that is deepening in many states of the union. c. problem #3: underminingofpersonalized care by population-based medicine health care providers treat individual patients, not statistically significant groups. what may be the best treatment for the group on average might not necessarily be the appropriate treatment for an individual patient. enforcing uniform clinical guidelines on patients whose conditions and values are anything but uniform is like trying to dress everyone in average-sized clothes regardless of their particular sizes and preferences. medical treatment decisions depend on a combination of factors--such as age, ethnicity, genetic background, severity of disease, comorbitidies,51 and patient values-which physicians must incorporate into their evaluation of a patient's treatment options. the medicare population is especially heterogeneous because of the prevalence of multiple illnesses in the elderly. twenty percent of medicare beneficiaries have five or more chronic conditions, and fifty percent are receiving five or more medications. 52 accordingly, congress should question the appropriateness of using financial incentives to impose population-based clinical results on individual 48. mark moran. pay for performance must be quality issue, ama says, 40 psychiatric news 9, 9 (2005). 49. ld. 50. brase, supra note 46, at 2. 51. comorbidities are defined as concurrent but unrelated medical conditions. stedman's medical dictionary (28th ed. 2006). 52. tinnetti, supra note 35, at 2870. 2006] pay for performance or compuance? 411 patient care. one study of 1, 755 type 2 diabetics found a twenty-four percent rate of noncompliance with clinical guidelines by internists. far from finding a deficiency in quality, the researchers found instead "a deficiency in the definition of what constitutes best practices."53 among the clinical guidelines were periodic retinal eye exams and urine protein screens for microal­ buminuria. many physicians questioned the usefulness of the urine screen for patients already receiving ace inhibitors, the indicated therapy for microal­ buminuria. in another example of "noncompliance," some patients did not receive eye exams because they were blind. the authors concluded: "our data suggest that failure to follow guidelines is not necessarily explained by 'bad doctors' or forgetfulness; rather, noncompliance may reflect valid questions about the usefulness and applicability of a best practice to an individual patient. "54 in addition to limiting a doctor's ability to act in the best medical interest of an individual patient, one-size-fits-all clinical guidelines ignore the role of patient preferences and values in health care decisions. this is especially relevant to the medicare population. evidence shows that elderly patients with multiple conditions vary widely in their preferences regarding longer survival, disease prevention, quality of mental and physical functioning, level of inconvenience and pain, and risk of complication. 55 a system of standardized treatment decisions is simply incompatible with the variability found in medicine. even if it were possible to create evidence-based rules for every possible variation of patient characteristics and conditions, the sheer number of guidelines would be overwhelming and impossible to implement. medical studies provide useful information about treatment options that may or may not work in a given situation, depending on the unique combination of circumstances involving the individual patient. however, the very nature of the statistical process, which minimizes bias and seeks mean tendencies, makes it insufficient to make the fmal decision for 53. national center for policy analysis, are "best practices" always best?, http://www.ncpa.org/isslhea/pdl2060lc.html (last visited may 20, 2006). 54. christel mottur-pilson et al., physician explanations for failing to comply with "best practices", 4 effective clinical prac. 207, 212 (2001), available at http://www.acponline.org/joumals/ecp/sepoctollpilson.pdf (last visited may 20, 2006). for another illustration of the incompatibility of population-based guidelines with high-quality individualized care involving an example of colorectal cancer screening within the veterans administration, see louise c. walter et al., pitfalls of converting practice guidelines into quality measures, 291 jama 2466, 2466 (2004). 55. tinnetti, supra note 35, at 2871. one study of 414 hospitalized patients eighty years old or older at four academic medical centers specifically measured health values of the elderly with respect to quantity vs. quality oflife and other factors. the authors found that "preferences varied greatly'' and recommended: "because proxies and multivariable analyses cannot gauge health values of elderly hospitalized patients accurately, health values of the very old should be elicited directly from the patient." joel tsevat et al., health values of hospitalized patients 80 years or older, 219 jama371, 371 (1998). 412 indiana health law review [vol. 3:391 every patient. mathematical models or algorithms cannot capture that precise moment of human choice that is the essence of medical judgment. physicians must be free to use their best medical judgment to make clinical decisions that incorporate all relevant factors and available evidence. appropriate medical decisions cannot be made using an assembly-line mentality that treats every patient like a generic commodity traveling down a conveyer belt. as expressed by dan mendelson, president of the health strategies consultancy in washington, d.c., "patients expect their doctor to tailor care to their individual condition, incorporating their medical history and preferences, the doctor's experience with similar patients, the most current research, and alternative therapies."56 to do otherwise not only does a disservice to the patient, but also can ultimately increase morbidity and mortality, which in tum can increase the cost of medicare. d. problem #4: deterioration of clinical judgment and medical innovation the fourth problem with a pay-for-compliance health care system is the deterioration of creativity, innovative ability, and medical judgment that will occur in an environment that devalues such qualities. with compensation hinging on adherence to guidelines, providers will become highly skilled at adhering to guidelines. in anticipation of a medicare pay-for-performance shift, the growing "medicare industrial complex" of lobbyists, lawyers, consultants, and professional "experts" who make a living deciphering and explaining the medicare bureaucratese have already swung into action. companies are already advertising "pay-for-performance prep guides," containing 400 pages of strategies to "ensure [that] your practice/organization succeeds with p4p [pay for performance]."57 as doctors treat the practice of medicine as if it were an sat exam, with right and wrong answers and grades handed out by the government, their ability to be flexible, innovative, and discerning in patient care will suffer. focused on the specific tasks that are linked to fmancial rewards, automatic practitioners of government-prescribed behaviors will replace doctors who are skilled in combining multiple sources of knowledge with their best medical judgment in providing patient care. medical students, interns, and residents will become trained in applying the third-party rules that govern their clinical decisions instead of developing keen clinical judgment and learning to constantly seek better ways to treat 56. dan mendelson & tanisha v. carino, evidence-based medicine in the united states -de rigueur or dream preferred?, 24(1) health aff. 133, 134 (2005). 57. part b news and decisionhealth, pay-for-performance prep guide, http://www.partbnews.com/tools/p4p/ (last visited may 20, 2006). 2006] pay for performance or compuance? 413 patients. 58 proponents claim that this will "structure the environment in which care is delivered so that 'doing the right thing' becomes automatic!'59 however, the ''right thing" can differ from patient to patient and often changes over time. a 2001 study published in the journal of the american medical association found that of seventeen clinical practice guidelines published by the agency for healthcare research and quality and still in circulation at the time, seven were in need of a major update, six required a minor update, and only three were determined to be valid. no conclusion was reached for the remaining guideline. using survival analysis, the researchers found that about half of the guidelines were outdated in 5.8 years.60 a health care system that ties reimbursement to sometimes outdated or low-quality guidelines would, at least occasionally, force providers to choose between financial compensation and their ethical duty to provide high-quality care. even worse, it could produce physicians who do not know the difference. doctors reimbursed according to compliance will also lose the incentive and ability to innovate that has produced so many important medical advances. in the late 1960s and 1970s, dr. charles kelman, an innovative ophthalmo­ logist, challenged the entrenched ''best practices" of his day and pioneered groundbreaking new methods of cataract surgery despite severe derision from colleagues. dr. kelman's innovative techniques revolutionized the field of cataract removal and ultimately became the standard by which all cataract surgeries are performed today. in fact, many consider him to be one of the greatest medical innovators because of the miracle that he wrought with cataract surgery and the millions of patients who have benefited from it. 61 if government-instituted compliance mechanisms had been in place in the 1960s and 1970s, however, dr. kelman would have dared such innovation only at his own financial peril, because any deviation from the guidelines would have lowered his pay-for-performance. scores. unless we believe that today's medical practice has reached a state of perfection and is unlikely to be improved, it seems shortsighted to discourage similar advances in the future. in the long run, automatic adherence to protocols is counterproductive. physicians ·need to respond effectively to a changing medical world and unique patient challenges, but compliance-based payment systems would deprive them of the very ability to judge appropriate care and adapt with innovative methods of treating illness. ultimately, the political negotiations 58. alan muney, oxford health plans. explains, "the pwpose ..• [of evidence-based education] is to drive lifelong adherence to clinical ~ce guidelines resulting in improvement in the value ofhealthcare expenditures." brase, supra note 46, at 3. 59. kim a. eagle et al., closing the gap between science and practice: the need for professional leadership, 22(2) healthaff. 196, 199 (2003). 60. paul g. shekelle et al., y alidity of the agency for healthcare research and quality clinical practice guidelines: how quickly do guidelines become outdated?, 286 jama 1461, 1461 (2001). 61. robert p. gervais, cataract surgery: a lesson on "best practices, "15 azmeoicine 21, 25 (2004). 414 indiana health law review [vol. 3:391 of bureaucrats and statisticians would replace the medical judgment of individual doctors and remove their incentive to do anything more than what is expressly required to earn their reward. e. problem #5: poor quality because of unproductive gaming behavior in a letter published in the new england journal of medicine, roy b. verdery, ph.d., m.d., claimed, "economic incentives are always subject to 'gaming,' inappropriate manipulation of data, and 'cherry-picking' of patients .... most physicians (and .other professionals) work for rewards that are more important than money, including the respect of their patients and peers and the personal satisfaction of a job well done."62 by diverting the focus of doctors and other medical professionals from appropriate patient-centered medical care to superficial financial rewards, pay for performance will likely create incentives to game the system in several detrimental ways that may cause real quality to decline even while measured indicators are improving. first, basing financial compensation on specific indicators leads to adverse selection. in other words, providers will tend to select relatively healthier patients who have a higher probability of complying with physician orders, achieving better outcomes, and thus improving the provider's bottom line. two recent studies on cardiologist report cards in new york illustrate this concem.63 the first study looked at more than 80,000 patients from new york and michigan and found that doctors in michigan, which does not issue report cards, were more likely to perform angioplasties on very sick patients. the second, published in archives of internal medicine, found that approximately eighty percent ofnew york cardiologists said that the system made them less likely to treat severely ill patients.64 if selection is such a significant concern when information about physician performance is merely reported, one can imagine the impact when it is directly tied to compensation. compliance-based compensation could also encourage providers to falsify records to circumvent the system and provide needed care. one study found that thirty-nine percent of physicians already falsify insurance records to secure needed services for patients.65 government-endorsed, standardized medicine would magnify this problem. finally, if congress ties money to specific medical interventions, doctors and other medical professionals will be pressured to focus on those 62. roy b. verdery, paying physicians for high-quality care, 350 new eng. j. med. 1910, 1910-11 (2004). 63. daniel costello, rating doctors: who benefits?, l.a times, june 13, 2005, at fl. 64. craigr narins etal., thelnjluenceofpublicreportingofoutcomedata on medical decision making by physicians~ 165 .archives internal men. 83; 83-87 (2005). 65. aspden, supra note 43, at 267. 2006] pay for performance or compliance? 415 interventions to the detriment of other important areas of medicine. pay for performance's very premise is that financial incentives alter behavior. while very few doctors will allow them to completely consume their behavior, the nature of financial incentives will push them in certain directions. as a result, some conditions and some procedures will receive less than adequate attention. "inevitably ... the dimensions of care that will receive the most attention will be those that are most easily measured and not necessarily those that are most valued," according to a recent study in health affairs on provider incentives.66 mitigating this problem would require increasing the number of required measurements, which would soon become overwhelming and counterproductive, even if there existed the possibility of doing so adequately. thus, while adherence to measured indicators might show improvement, overall quality might become worse. instead of adjusting their behavior to a set of standard rules and guidelines, health care providers should be encouraged to meet their patients' needs and preferences in a comprehensive way. this cannot be accomplished in an arbitrary system of compliance-based incentives that encourages providers to manipulate the "game" to their fmancial advantage. f. problem #6: further weakening of the doctor-patient relationship "one major barrier to the adoption of ebm," according to analysts writing in health affairs, "is the overwhelming support for preserving the physician-patient relationship."67 a medicare pay-for-performance system would lead to a decline in this relationship. when patients understand that their physicians are being pressured to meet standardized treatment directives rather than to provide them with customized care based on their unique conditions and preferences, trust in their physicians will be compromised­ and for good reason. a 2003 study published in the journal of ambulatory care management showed that physicians operating under imposed financial incentives are much less likely to feel strongly that they can make clinical decisions in their patients' best interests without adverse financial consequences. because of misaligned incentives, these physicians also feel less able to obtain medically necessary services for their patients.68 various studies have shown that such 66. meredith b. rosenthal et al., paying for quality: providers' incentives for quality improvement, 23(2) health aff. 127, 139 (2004). 67. mendelson & carino, supra note 56, at 134. 68. jeffrey j. stoddard et al., financiallncentives and physicians' perceptions of conflict of interest and ability to arrange medically necessary services, 26 j. ambulatory care mgmt. 39, 45 (2003). 416 indiana health law review [vol.3:391 patients understood and internalized the consequences of alternate payment methods and that this affects their level oftrust in their health care providers.69 from the physician's perspective, the doctor-patient relationship changes dramatically when the patient's actions determine the physician's compensation. if the patient does not follow the physician's treatment plan, does not take medication as prescribed, or continues to engage in risky behavior, adverse results can occur. these will be reflected in the physician's rating and thus in the physician's pay-for-performance compensation. as physicians struggle with the demotivatingreality ofbeingheld accountable for another person's behavior, which they do not control, their frustration levels will increase substantially, and they will come to see their patients as obstacles to overcome rather than as fellow human beings in need of care. the doctor-patient relationship is crucial to patient care because high­ quality health care hinges on personal trust. medical decisions are complex, and patients do not have the level. of expertise necessary to navigate them alone, so they must be able to trust their doctors with the most intimate information about their health condition. they trust their doctors to advise them on their most important decisions, matters oflife and death, sickness and health. combining full information and patient trust, physicians can provide the information and guidance needed to make good decisions. however, trust requires that patients believe that their provider is acting in their best interests. once patients realize that their physicians are trying to serve two masters--4he patient and the third-partypayer--4h.ey will be unable to maintain the same level of trust in their providers. they are not likely to replace that trust with trust in the government agency creating federal treatment guidelines. vi. what congress should do congress should revisit medicare reimbursement in the context of enacting real medicare reform, transforming medicare into a system of ''premium support" that resembles the federal employees health benefits program, as originally recommended in 1999 by the majority of the national bipartisan commission on the future of medicare. with such a comprehensive reform, the current irrational national system of administrative pricing, price controls, perverse incentives, and regulatory overkill would simply disappear. short of comprehensive medicare reform, congress should fix what is broken, not make it worse. instead of responding to the inefficiencies of central planning by instituting even more intrusive forms of central planning, 69. audiey c. kao et al., the relationship between method of physician payment and patient trust, 280 jama 1708, 1708-13 (1998); anne g;pereira & steven d. pearson, patient attitudes towardphysicianfinanciallncentives, l61 archm!sinternalmed.1313, 1313-17 (2001). 2006] pay for performance or compliance? 417 congress should move medicare reimbursement in the opposite direction by removing barriers to a freely functioning, consumer-driven health care market. the key driver of value in a free market is competition to meet consumer demand. consumers must have access to full information about services and must be free to choose those services from doctors of their choice. doctors must be free to adjust the prices of the services that they offer. to create a market that improves quality and value within the medicare system, congress should take the following actions: 1. reject pay-for-performance reimbursement proposals. medicare pay for performance would do more to mandate compliance with centrally determined treatment processes than it would to improve the quality of care delivered to medicare beneficiaries. further separating patients' needs and personal preferences from the medical care that they receive would only exacerbate the long­ term budget crisis. congress should halt attempts to push medicare into compliance-based compensation programs and instead act to implement a market-oriented payment system that drives value according to the demands of the consumer. 2. jettison the sgr and the medicare fee schedule and substitute annual physician payment updates and medp ac adjustments. the complex program of price controls and central planning that governs medicare reimbursement is a conceptually flawed system that burdens doctors with unnecessary bureaucratic obstacles, fails to control costs, and threatens seniors' access to high-quality health care. 70 this command-and-control approach to paying for health care should be replaced by a payment system that is both predictable and reflects market forces. in addition, as representative nancy johnson has proposed, the sgr payment update formula should be scrapped in favor of an annual update. this update could be based on the consumer price index or the medicare economic index, which tracks changes in the costs of medical care. either index would be a much more rational benchmark for physician reimbursement and would prevent the absurd predicaments of the past several years in which congress has intervened at the last minute to save physicians from payment rate decreases. to correct for imbalances among specialties that may occur under an annual update, congress could commission 70. for additional details on the conceptual flaws of the current medicare fee schedule, see robert e. moffit, comparable worth for doctors: a severe case of government malpractice, heritage found. backgrounder no. 855, sept. 23, 1991, available at http:/jwww.heritage.orgfr.esearch!healthcare!bg855.c:fin (last visited may 20, 2006); h.e. frech iii, overview of policy issues, in regulating doctors' fees: compensation, benefits, and controls under medicare (h.e. frech iii ed., 1991 ). 418 indiana health law review [vol. 3:391 med.p ac to recommend adjustments on the basis of market surveys in order to reflect real changes in supply and demand in the medical market. 3. remove medicare restrictions on balance billing and private contracting. prices for health care services delivered to medicare recipients are currently fixed by balance-billing restrictions. beyond these conventional medicare billing limitations, even if a medicare enrollee wanted to pay out of pocket to receive more of a given service than medicare allows (e.g., a greater number of physician visits to a nursing home), he or she could not do so without encountering other legal restrictions. 71 the most important is a legal obstacle to private contracts in medicare, coincidentally the feature of canada's single-payer system that was recently declared unconstitutional by the canadian supreme court because it can result in increased patient suffering. 72 medicare's restrictions on private contracts should be lifted, subject to a means test to protect the wlnerable, and provider prices should be allowed to fluctuate with positive or negative balance billings, even if the government's share is fixed through prospective payment. the medicare beneficiary freedom to contract act (h.r. 709), 73 introduced by representative sam johnson (r-tx), would remove all restrictions on private contracts between medicare beneficiaries and health care practitioners. 4. require price transparency of medicare-reimbursed services. price is the mechanism by which buyers and sellers communicate in the marketplace. vigorous competition to provide the best quality at the best price drives superior performance. despite the importance of price, health care consumers currently find it very difficult to acquire pricing information from providers, even when they make a concerted effort to do so. a recent survey by towers perrin of 1,400 employees in various health plans found that eight-five percent felt that they needed more information to make good health care decisions, specifically information about price and quality.74 physicians and other health care providers in 71. as cited earlier, under medicare law, with certain regulatory exceptions, any physician who establishes a private contract to treat a medicare patient is prohibited from billing medicare for any patients for two years. supra note 16. 72. jacques cbaoulli, lecture at the heritage foundation (july 22, 2005) (transcript available at http://www.heritage.orgiresearch/healthcarelhl892.cftn (last visited may 20, 2006)). 73. h.r. 709, 109th cong~ (2005). 74. vanessa fuhrmans, patients give new insurance mrxed reviews, w au. st. j., june 14, 2005, at dl. 2006] pay for performance or compliance? 419 medicare should be obligated to publish prices and make them available, when possible, to patients before procedures are performed. 5. encourage private-sector development of quality information. the universal disclosure of prices will generate patient demand for better information about quality of care. if consumers, with the help ofhealth care professionals, decide which criteria they value and which sources of information they wish to rely upon in making their decisions, the private sector will respond with patient-empowering tools that increase the capacity to make personal medical decisions. combined with knowledge about price, these tools will enable medicare beneficiaries to make choices that drive providers to compete for patients by using all available components of appropriate medical care, thus pushing health care to higher levels of quality and value. vii. conclusion the current effort to change the payment system is well intentioned. moreover, the rhetoric of"quality-based purchasing" advocates, including a reliance on evidence-based medicine, best practices, and pay for performance as methods to improve health care quality, is appealing. in reality, however, they would further bureaucratize health care. members of congress need to ask themselves whether they want the government to interfere with the practice of medicine--an intervention that they statutorily prohibited when they enacted medicare in 1965. they also need to determine whether more central planning is real reform, or whether such an approach will only further distort an already dysfunctional system, resulting in even greater difficulties for american seniors. the negative impact of a payment system that demands compliance with standardized processes is predictable and significant. americans not only would find themselves in the type of government-controlled health care system that they· have perpetually rejected, but also would see population­ based study results applied to their individual situations despite their unique health conditions, their personal values, and their doctors' experience. they would find themselves under the care of physicians restricted in their ability to exercise their best medicaljudgmentto tailor care to their patients' specific situations and preferences. these physicians would have more incentive to check the boxes on the automatic protocol lists that generate compensation than they would to act in the best interests of their patients. this would undoubtedly decrease the level of medical innovation and weaken the doctor-patient relationship. a new medicare payment system should differentially reward providers who do a better job of satisfying the needs, preferences, and values of patients. however, if it rewards providers for submitting to directive protocols that 420 indiana health law review [vol. 3:391 reflect the financial and political incentives of third-party bureaucrats, it is merely paying for compliance. the result will be greater distortions and inefficiencies in medicare, further compromising quality, cost savings, and seniors' access to care. rather than follow this course of top-down micromanagement and artificial competition, congress should base medicare reimbursement reform on the free-market principles of price transparency, private contracting, and consumer choice, thus removing baniers to real competition and promoting high-quality and high-value patient-centered health care. putting patients first: how the fda could use its existing powers to reduce post-market adverse events putting patients first: how the fda could use its existing powers to reduce post-market adverse events jennifer s. bard* i. introduction.............................. 496 ii. scope of problem ............................... 502 iii. gathering the information about post-market adverse events .......................... ..... 510 a. the sponsors (drug companies) ............... 510 b. getting information from health care providers ... 516 1. prescribing physicians .................. .... 516 2. other health care providers ................. 519 3. pharmacies and pharmacists ................ 521 c. getting information from patients. ............. 522 d. investing in monitoring technology....... .......... 524 e. helping the fda make use of the information it receives ............................. ..... 526 f. effective solutions ...................... ..... 529 1. expanding whistleblower protection ..... ...... 529 2. models of strong whistleblower protection in recent federal statutes .............................. 530 3. using active surveillance .............. ..... 531 4. monitoring harm and protecting whistleblowers through bioinformatics ................ ..... 533 5. technology to encourage information sharing ..... 537 6. getting information to the fda..... ............. 538 7. barriers to expanding access to information........540 8. accepting anonymous complaints ............ 542 iv. policy arguments ........................ ...... 545 * jennifer s. bard, j.d., m.p.h., ph.d. is the alvin r. allison professor of law and director, health law program and j.d./m.d. dual degree program at the texas tech university school of law as well as professor (adjunct) texas tech university school of medicine, department of psychiatry. many texas tech and drake law school students provided helpful research assistance. these include katie kennon ahlrich, charles blevins, courtney burns, kathryn heflin, steven kubik, and justin s. mcanally. thank you also to senior business assistant michele thaetig. this article is dedicated to professor emeritus barbara t. bard. indiana health law review a. normative arguments............. .... ....... 545 1. positivist arguments ................. ...... 547 2. cost-benefit analysis ...........................547 3. criticisms based on efficacy. ....... .......... 550 v. constitutionality ........................ ...... 551 a. federalism ............................ ..... 552 b. conflict with existing state laws: pre-emption ...... 554 vi. conclusion ................................ .... 556 i. introduction the danger to the health of patients taking drugs) 1 recently on the market after being approved by the food and drug administration (fda) is well documented. 2 while there may be problems inherent to the drug itself, what is emerging as a more serious issue is possible "drug-drug 1 this article specifically considers post-market adverse events caused by drugs because the regulation system for devices and biologicals is somewhat different. 2 commentators use both the terms "post-approval" and "postmarket" to refer to the time when a drug has been cleared for sale to consumers. see rodney k. miller, sacrificial lambs: compensating first subscribers to fda-approved medications for postmarketing injuries resulting from unlabeled adverse events, 62 cath. u. l. rev. 429, 431 (2013) (postmarketing discovery of adverse effects is common and continues today"). see also marc a. rodwin, conflicts of interest, institutional corruption, and phalrm4: an agenda for reform, 40 j. l. med. & ethics 511, 514 (2012) ("typically, the population that uses a drug is more diverse than the small group of subjects on which the drug is tested. drugs often are tested on middle-aged adults, but are later used by many individuals who are more susceptible to drug injuries, like children, the elderly, or pregnant women. furthermore, pre-market trials cannot identify health problems that arise only after long-term use. yet, many drugs are meant for long-term use; for example, drugs, for birth control, to stabilize blood sugar for diabetes, or to control high blood pressure, cholesterol, depression, or mood disorders. also, a physician may prescribe drugs in ways that differ from how they were tested. the pre-market trial may test a pain reliever for short-term acute use, but some physicians may prescribe it for continuing use. moreover, some injuries are caused by the interaction of two or more drugs, and are not discovered until they have been marketed and used by a larger population."). 496 vol. 10:2 putting patients first interactions (dds)" between a newly approved drug and the drugs already being taken by the patient. researchers at stanford university recently noted that "ddis cause nearly 74,000 emergency room visits and 195,000 hospitalizations in the usa."3 this situation is not due to laxity by the fda so much as it reflects the current state of health care. as professor barbara evans explains, the fda plays the role as "gatekeeper" in assessing the safety and efficacy of drugs, and other products, before they go on the market but as a matter of "realism" because "[t]he gate is intrinsically porous, and safety cannot be achieved by fighting that fact but rather by responding to it."4 indeed, concerns about the problem resulted in congress extending the fda's ability to require manufacturers to conduct their own research studies to assess the safety and efficacy of the drugs they sell not just before seeking fda approval but afterwards as well.5 yet despite the awarding of these new 3 bethany percha and russ b. altman, informatics confronts drug-drug interactions, 24 (3) trends in pharmacological sciences 178, 178 (2013) http://www.sciencedirect.com/sciencelarticlelpii/s0165614713000072, http://dx.doi.org/10.1016/j.tips.2013.01.006 (last visited june 23, 2013) ("according to the centers for disease control (cdc), the percentage of the us population taking at least one prescription drug within the last 30 days increased from 39.1% in 1988-1994 to 47.5% in 2007-2010. during that same period, the percentage of americans taking three or more prescription drugs rose from 11.8% to 20.8%, and the percentage taking five or more drugs increased from 4.0% to 10.1%."). 4 barbara j. evans, seven pillars of a new evidentiary paradigm: the food, drug, and cosmetic act enters the genomic era, 85 notre dame l.rev. 419, 477 (2010). 5 the authority comes from the food and drug administration amendments act of 2007 (fdaa) 21 u.s.c.a. § 355(o)(3) (west 2012) which adds section 505(0)(3) to the federal food, drug and cosmetic act (ffdca) pub. l. no. 75-717, 52 stat. 1040 (1938) (codified as amended at 21 u.s.c. §§ 301-399d (2006)). in 2011 the fda issued guidance to the pharmaceutical industry as to how it would implement its new authority. ctr. for drug evaluation & research & ctr. for biological evaluation & research, u.s. dep't of health & human servs., guidance for industry: postmarketing studies and clinical trials-implementation of section 505(o)(3) of the federal food, drug, and cosmetic act (2011) [hereinafter fda, april 2011 guidance], available at http://www.fda.gov/downloads/drugs/ guidancecompliance regulatorylnformation/guidances/ucm172001.pdf (last visited june 23, 2013). see generally, barbara j. evans, the ethics of postmarketing 4972013 indiana health law review powers, there is still no comprehensive mechanism in place to gather the information needed to protect or warn patients who receive these prescriptions. 6 so although the fdaa gives the fda the authority to require sponsors to conduct post-market clinical trials if it is aware of "a known serious risk related to the use of the drug involved" 7 it also authorizes the fda to "[alssess signals of serious risk related to the use of the drug."8 this article proposes ways in which the fda can use this power to promote and protect the public's health. there have been numerous reports by or commissioned by the fda or other government and private observational studies of drug safety under section 505(0)(3) of the food, drug, and cosmetic act, 38 am. j. l. & med. 577 (2012) (describing the fda's new powers and expressing concerns about ethical issues arising from pharmaceutical companies conducting their own post-market research). 6 that there is no comprehensive system in place does not mean that none have been proposed. the public citizen's health research group in washington, d.c. advocates a "do-not-use-for-seven-yearsrule" which means that "unless a new drug is a breakthrough medication for a condition for which there were no previously good options, we recommend that people not take it for at least seven years." see ananya mandal, older drugs may be better than newly approved ones, news medical (sept. 13, 2011) (quoting dr. michael carome, deputy director of public citizen's health research group), http://www. news-medical.net/news/20110913/older-drugs-may-be-better-than-newlyapproved-ones.aspx. 7 21 u.s.c. § 355(o)(3)(b). 8 for an overview of fda drug regulation see susan thaul, how fda approves drugs and regulates their safety and effectiveness, congressional research service (2012) http://www.fas.org/sgp/ crs/misc/r41983.pdf; see 21 u.s.c. §355(b)(6) (the term "signal of a serious risk" means information related to a serious adverse drug experience associated with use of a drug and derived from(a) a clinical trial; (b) adverse event reports; (c) a postapproval study, including a study under section 355 (o)(3) of this title; (d) peer-reviewed biomedical literature; (e) data derived from the postmarket risk identification and analysis system under section 355 (k)(4) of this title; or (f) other scientific data deemed appropriate by the secretary."). 498 vol. 10:2 putting patients first entities. 9 the goal of this article is to gather this information, re-affirm why change is necessary, suggest two 9 a series of institute of medicine reports collectively reflect its assessment of the problem of patient safety after a drug has been approved by the fda and put on the market. institute of medicine, board on population health and public health practice, the future of drug safety: promoting and protecting the health of the public (september 22, 2006) (assessment of the u.s. drug safety system); http://www.iom.edu/reports/2006/the-future-of-drug-safetypromoting-and-protecting-the-health-of-thepublic. aspx, institute of medicine, board of health sciences policy, adverse drug event reporting, the roles of consumers and health care professionals, http://www.iom.edu/reports/2007/adverse-drug-eventreporting-the-roles-of-consumers-and-health-care-professionals-workshopsummary.aspx (april 12, 2007) (forum on drug discovery, development, and translation); institute of medicine board on health sciences policy, understanding the benefits and risks of pharmaceuticals. workshop summary (august 15, 2007) (forum on drug discovery, development and translation), http://www.iom.edulreports/2007/understanding-thebenefits-and-risks-of-pharmaceuticals-workshop-summary.aspx; institute of medicine, board on health sciences policy, challenges for the fda: the future of drug safety (september 10, 2007)(forum on drug discovery, development and translation), http://www.iom.edu/reports/ 2007/challenges-for-the-fda-the-future-of-drug-safety-workshopsummary.aspx; institute of medicine, ethical issues in studying the safety of approved drugs letter report (july 9, 2010) (quality and patient safety, biomedical and health research) http://www.iom. edu/reports/2010/ethical-issues-in-studying-the-safety-of-approveddrugs-letter-report.aspx; institute of medicine, board on population health and public health practice (october 14, 2010)(public health effectiveness of the fda 510(k) clearance process) http://www.iom.edu/ reports/2010/public-health-effectiveness-of-the-fda-510k-clearance-processbalancing-patient-safety-and-innovation.aspx; institute of medicine, board on population health and public health practice, public health effectiveness of the fda 510(k) clearance process: measuring postmarket performance and other select topics workshop report (november 18, 2010), http://www.iom.edulreports/2010/public-healtheffectiveness-of-the-fda-510k-clearance-process-measuring-postmarketperformance-and-other-select-topics.aspx; institute of medicine board on population health and public health practice, institute of medicine board on population health and public health practice , the safe use initiative and health literacy workshop summary(december 1, 2010) http://www.iom.edu/reports/2010/the-safe-use-initiative-and-healthliteracy-a-workshop.aspx; ethical and scientific issues in studying the safety of approved drugs (may 1, 2012) (quality and patient safety, biomedical and health research), http://www.iom.edu/reports/ 2012/ethical-and-scientific-issues-in-studying-thesafety-of-approved2013 499 indiana health law review additional measures that so far have not been proposed, the addition of whistleblower protection and greater use of electronic medical and pharmaceutical records, and explain why the fda could make these changes itself rather than await action from congress. it is the claim of this article that although the phenomena of the emergence of postapproval hazards is inevitable, the fda can do far more to protect patients by using its legal authority to require postmarket surveillance for all, not some, newly approved products. moreover, it can increase the likelihood of relevant information coming to its attention sooner by targeting the specific groups who are likely to have early knowledge of harms caused by new drugs: the sponsors, health care providers, patients, and the fda itself. specifically, the fda should amend the approval process to create formal post-market surveillance on all newly approved drugs. it should impose requirements on sponsors to seek out information about potential problems, to organize that data in a way that is easy to review, and to report that information directly to the fda on a regular basis for at least two years after the product is on the market. moreover, because the fda's resources will always be less than the drug sponsor, who expects to profit from product sales, the burden of discovering and analyzing postmarket adverse events should be shifted to the drug sponsor. this article makes several new suggestions as well as highlighting those already proposed by scholars, the institute of medicine and consumer groups to find potential problems sooner by making information about potential dangers, both pre-approval and once the drug is on the market. these include: * increasing access to information available, now, only to pharmaceutical companies by implementing anti-retaliation protections for potential whistleblowers * requiring that sponsors pro-actively search for and turn over to the fda all drugs.aspx. 500 vol. 10:2 putting patients f hst information which could lead to a conclusion that a recently released drug is causing harm not apparent to the fda during its review process. * requiring sponsors to notify patients that they are taking a recently approved product and provide a mechanism for them to quickly and easily report any unusual experiences, which may be attributable to the new product. * monitoring the medical and pharmacy records of patients taking newly approved drugs to detect patterns of harmful side-effects or interactions. * opening the door to the information obtained by the prescribing physicians by both requiring that all information acquired by the sponsor through direct or indirect contact be reported to the fda. * making use of up-to-date bioinformatics techniques to survey all available data on new drug use that could indicate emerging problems. this article reviews the problems the fda faces in getting the information it needs to protect the public's health after it approves a drug, device or biologic and then makes several proposals for stronger measures, all within the fda's existing regulatory authority, to ensure that the fda has access to the information it needs make evidencebased regulatory decisions. this article concludes that the current culture which differentiates between the importance of fda oversight in approving the drug and fda oversight post-approval is the cause of a persistent and often deadly failure to carry out its statutory mission of making sure that all drugs, devices and biologics subject to its regulation are both safe and effective for the patients who depend on them. however, the sponsors who have spent billions in the development and approval process are 5012013 indiana health law review not likely to welcome a warning that a drug may pose unknown risks. ii. scope of problem no one knows, with certainty, how many patients suffer harm that can be directly attributed to their having taken a recently approved drug, but common sense suggests that a previously unknown reaction is more likely to occur with a new drug. the fda reports that there are over 2 million serious adverse drug reactions every year and among those 100,000 deaths. 10 it is often the case that a drug manufacturer knows of potential health concerns quite soon after the drug is available on the market. this is because problems emerge in the testing process and are not reported to the fda, or because their network of representatives receive reports from prescribing physicians although the fda certifies drugs as "safe and effective" before allowing them on the market, they do so based on the information available to them at the time. it is, however, inevitable that issues will emerge over time as they are used by many more patients 11 and by patients with characteristics different from the subjects on which the drug was tested. indeed, subjects in drug trials are often far less sick than those patients who will eventually be taking the drug once it is on the market. 12 thus, no matter how much 10 kenneth wu wenchen and nicholas pantaleo, evaluation of outpatient adverse drug reactions leading to hospitalization, 60 am. j. health syst. pharm. 3, 3 (2003). "the growing number of newly approved drugs and the increased potency of these medications, coupled with the complex disease treatments, have contributed to the increased risk of adverse drug reactions (adrs) in the ambulatory care setting." see percha and altman, supra note 3. 11 see evans, 85 notre dame law review supra note 4 at 445 ("premarket drug trials are simply too small to detect rare adverse events, yet even rare risks can generate large number of causalities once a drug is marketed to millions of people"); rodwin, supra note 2 at 514 ("pre-market clinical trials use a sample that is too small to identify many of the adverse drug reactions that will occur in much larger populations"). 12 evans, 85 notre dame l. rev. supra note 4 at 448-449 ("clinical trials admit subjects who are, on average, less likely to suffer adverse 502 vol. 10:2 putting patients first information a drug sponsor provides to the fda in support of the drug's safety and effectiveness, once the drug is approved it can be prescribed by almost any physician for any medical condition.13 as a result, even if the fda is aware of a potentially dangerous drug interaction and requires that drug sponsors warn against its use in these specific populations or in combination with other drugs, there is nothing to stop a physician from substituting his or her own judgment for that of the fda and writing such a prescription. without debating the merits of retaining these broad prescribing powers, it is self-evident that the practice of off-label prescribing makes it impossible for the fda to conduct a safety and efficacy review relevant to all the people to whom the drug may be prescribed. there are two inherent characteristics of clinical trials which guarantee that products go on the market without complete information. the trials involve less people and cover a shorter period of time.14 some attribute the short testing time to the 1992 prescription drug user fee act events than other people. high-risk patients are deliberately excluded from trials both for commercial reasons (to make the interventional drug look good) and for ethical reasons (to minimize risks to research subjects") (citing kenneth l. melmon, attitudinal factors that influence the utilization of modern evaluative methods, in inst. of med., modern methods of clinical investigation 135, 142 (annetine c. gelijns, ed., 1990) available at http://www.nap.edulopenbook.php?recordid =1550&page-135 (last visited june 18, 2013)). 13 see fazal khan and justin holloway, verify, then trust: how to legalize off-label drug marketing, 117 penn st. l.rev. 407 (2012) (much of the publically available information on off-label prescriptions comes from the drug company's being caught and sued or prosecuted for their own efforts to expand their sales by engaging in the legal practice of promoting drugs for uses not approved by the fda. yet reason suggests that much off-label prescribing occurs without the awareness of anyone but the physician.); see also john e. osborn, can i tell you the truth? a comparative perspective on regulating off-label scientific and medical information, 10 yale j. health pol'y l. & ethics 299, 308-14 (2010). 14 see rodwin, supra note 2 at 514; see percha and altman, supra note 3 (explaining further that ddis are difficult to recognize because of aspects such as dose dependence of many ddis and natural genetic and demographic variation). 5032013 indiana health law review (pdufa) which allowed drug sponsors to finance a faster review of their product if they can show that it is needed for "serious or life-threatening illnesses that lack treatments." 5 indeed, the new england journal of medicine published a study in 2008 which found that the pdufa sets the fda a ten month deadline from application to a decision. but in the case of a drug for a chronic condition that may be taken for decades, it would be impracticable to extend the approval period. indeed, one study documented an adverse event that emerged 36 years after approval.16 as an article in the journal of clinical oncology nursing explains: most phase ii premarketing drug trials are statistically under-powered to detect adverse reactions, and treatment duration often is limited. in addition, patients in phase ii trials are prescreened for safety, comorbidities, and concomitant drugs. rare and serious events may occur after the drug is marketed and used in broader populations for longer durations.' 7 by their nature, adverse events are less likely to occur during a clinical trial than when a drug is actually administered to a patient. the primary reason is one of time. clinical trials are short-often lasting no more than 12 weeks. moreover, the sponsor itself determines the 15 u.s. food & drug admin., prescription drug user fee act (pdufa) iv: drug safety five-year plan 2008-2012, at 2 (2008), available at http://www.fda.gov/downloads/forlndustry/ userfees/prescriptiondruguserfee/ucm119244.pdf; see e.g., pamela halquist, 12(6) clin. j. oncol. nurs. 877-886 (2008), available at http://www.medscape.com/viewarticle/585694_2 (using as examples serious but delayed adverse effects of drugs intended to preserve the bones and increase red blood cells in patients undergoing chemotherapy which, instead, increased their risk of death) . 16 ladewski, l.a., belknap, s.m., nebeker, j.r., sartor, 0., lyons, a., kuzel, t.c., et al., dissemination of information on potentially fatal adverse rug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project, j. of clinical oncology, 21 (2003) 3859-66. 17 id. 504 vol. 10:2 putting patients first length of the trial. 18 as one commentator explains, "pharmaceutical companies may therefore have an incentive to design a protocol that lasts long enough to demonstrate the desired efficacy but not long enough to reveal the adverse effects associated with the compound."19 no one knows the extent to which drugs are prescribed "offlabel" but studies suggest it is a common practice. 20 a drug intended to treat a chronic condition like high blood pressure or depression may be taken by an individual patient for decades. another reason concerns the controlled circumstances under which clinical trials are conducted. unlike patients taking a medication at home who make annual visits to their physician, subjects in trials are monitored very closely. trends which might indicate potential adverse events, such as slowly rising blood pressure, can be identified before the occurrence of an adverse event. while petitioners are required to report subjects who drop out or who are excluded from a trial being submitted to support their application, it is often difficult to know why. another, more general concern, is that a drug 18 benjamin p. falit, curbing industry sponsors' incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results, 37 seton hall l. rev. 969, 987 ("adverse side effects associated with pharmaceuticals often arise only after the patient has been taking the medication for an extended period of time. this is frequently true even in cases where the compound's desired therapeutic effects appear immediately after administration of the first dose."). 19 id. at 984. 20 sandra h. johnson, polluting medical judgment? false assumptions in the pursuit of false claims regarding off-label prescribing, 9 minn. l.j. sci. & tech. 61, 64 (2008) (johnson argues that the prevalence of off-label prescribing is not merely because of drug company efforts to increase profits but rather reflects "deficiencies in the production and dissemination of clinical knowledge"); see david c. radley, stan n. finkelstein, and randall s. stafford, off-label prescribing among office-based physicians, 166(9) arch. intern med. 1021-1026 ("off-label medication use is common in outpatient care, and most occurs without scientific support. efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use")(2006). see also monika k. kryzanowska, off-label use of cancer drugs: a benchmark is established, 31 (9) journal of clinical oncology (2013). 2013 505 indiana health law review trial conducted by the company intending to market the drug may have an inherent bias towards reaching positive results.21 many recent events involving substantial harm to patients have become known through the filing of lawsuits. 22 although the fda can, and does, revoke approvals or require additional warnings put on labels it often does not act until the problem has become widespread. 23 it is inevitable that there is more information available about a drug or device's safety and efficacy in the months and years after it is being used by the general public than there is the day it was approved. as physician and law professor william m. sage explained in his student note, "extensive use in humans is the only way to measure safety or efficacy." 24 there are many reasons why problems 21 see trudo lemmens and candice telfer, access to information and the right to health: the human rights case for clinical trials transparency, 38 am.j.l. & med 63,93 ("a host of studies indicate that industry-sponsored trials are much more likely than other trials to conclude that drugs produced by the sponsoring company are safe and effective."). 22 for an account of the allegations and what is publically known regarding the settlement of a case involving a $2.5 million fine imposed on glaxosmithkline for harm caused by the drug paxil of which they were aware but did not report to the fda, see benjamin falit, the path to cheaper and safer drugs: revamping the pharmaceutical industry in light of glaxosmithkline's settlement, 33 j. l. med. & ethics 174 (2005). 23 see sandra h. johnson, polluting medical judgment? false assumptions in the pursuit of false claims regarding off-label prescribing, 9 minn. l. j. sel. & tech. 61, 62 (2008) ("off-label" prescribing, has raised significant concerns over the safety and efficacy of medications prescribed outside the scope of their fda approval"); 73 fed. reg. 2850 (jan. 16, 2008) (quoting 50 fed. reg. 7470 (feb. 22, 1985)); see generally tamsen valoir & shubha ghosh, fda preemption of drug and device labeling.' who should decide what goes on a drug label, 21health matrix 555 (2011) (explaining the process by which the fda requires that manufacturers place information about potential risks in the written material accompanying drugs it approves). 24 see william m. sage, note, drug product liability and health care delivery systems, 40 stan. l. rev. 989, 990 (1988) (acknowledging inevitable gaps in knowledge at the time of fda approval because "extensive use in humans is the only way to measure safety or efficacy"). 506 vol. 10:2 putting patients first may emerge after post-approval. one of the most common is that the relatively small study population does not have the same characteristics of the patients who will be taking the drug.25 this is especially true of populations designed as "vulnerable" under federal law such as children and pregnant women. 26 the issue of a possibly nonrepresentative study population is especially serious when a drug has been tested overseas. 27 for example, in withdrawing the approval of meridia, a weight loss drug, gerald dal pan, director of the fda's office of surveillance and epidemiology stated that, "[t]he patients in the european scout trial did not have the same characteristics as the patients for the approved indication in the united states; however, these results, combined with other available safety data raised serious questions about meridia's safety for all patient groups." 2 8 sidney wolfe, head of citizen's action, a public interest organization often in strong opposition to pharmaceutical companies, stated that his organization had been asking the fda to ban 25 see generally scott tillett, off-label prescribing of ssris to children: should pediatric testing be required, or are there other means to a safer end for children? 19 s.cal. rev.l. & soc. just. 447 (2010)) (describing how most drugs taken by children have not been tested on children); see also lainie friedman ross, children in medical research: access versus protection, 63 (john harris et al. eds., 2006). 26 am. med. ass'n, reporting adverse drug and medical device eventsreport of the am4's council on ethical and judicial affairs, 49 food & drug l.j. 359, 359-60 (1994) [hereinafter am4 report] (noting that "the patient population used in clinical trials does not usually include vulnerable populations such as the elderly, the young, women, those with complicated disease, or those taking other medications"); see generally 45 c.f.r. § 46.111 (2009). 27 fazal khan, the human factor: globalizing ethical standards in drug trials through market exclusion, 57 depaul l. rev. 877, 888 (2008) (describing how drug sponsors can "avoid... direct fda regulation" by asserting that their trials met the standards of the countries in which they were conducted). see 21 c.f.r. § 312.120(c)(1). 28 press release, united states food and drug admin., abbott laboratories agrees to withdraw its obesity drug meridia (oct. 8, 2010), available at http://www.fda.gov/newsevents/newsroom/press announcements/ucm228812.htm. 5072013 indiana health law review meridia since 2002.29 he also noted that the drug had already been on the market for eight months after the european medicines agency issued its recommendation to ban it.30 again, the issue is patient information. should a patient know that she is being prescribed a drug under fda review after the drug has been banned in europe? in 2011 and again in 2012 the institute of medicine issued reports detailing the harm caused by the fda's lack of effective procedures for monitoring the safety and effectiveness of medical devices (2011)31 and then drugs (2012). 32 the institute of medicine's committee investigating the process of post-market approval put the problem in stark terms. having outlined the many ways that these failures of post-market oversight had caused harm, it recommended that the fda take a "lifecycle approach" to its task of making sure that the drugs prescribed to the public were both safe and effective. 33 a key component of the "lifecycle" approach is to develop mechanisms for monitoring information about how the drug is actually working when administered to a large number of patients. the committee premised its recommendations on the fact that they were all within the power granted the fda by congress in the fda amendments act of 2007 (fdaaa),34 which provided the fda with new regulatory tools including the authority to mandate at the time of approval 29 bruce japsen & andrew zajac, abbot to withdraw diet drug meridia, l.a. times, oct. 8, 2010, http://articles.latimes.com/2010/oct/ 08/business/la-fi-1009-meridia-20101008 (last visited april 30, 2013). 30 id 31 institute of medicine of the national academies, medical devices and the public's health: the fda 510(k) clearance process at 35 years (2011), available at http://www.iom.edulreports/ 201 1/medical-devices-and-the-publics-health-the-fda-510kclearanceprocess-at-35-years/report-brief.aspx?page=2. 32 institute of medicine of the national academies, ethical and scientific issues in studying the safety of approved drugs (2012), available at http://www.iom.edu/reports/2012/ethical-andscientific-issues-in-studying-the-safety-of-approved-drugs. aspx. 33 id. at 2. 34 id. at 1; food and drug administration amendments act of 2007, pub. l. no. 110-85. 508 vol. 10:2 putting patients virst that the sponsor conduct post-market clinical trials or other research studies in the post marketing setting. in light of this authority, the committee proposed a three-stage framework for the fda to use in order to acquire postmarket information and to conduct periodic post-market evaluations of the drug's risk-benefit profile. 35 the committee's framework is based on giving priority to the perspective of the patient rather than on relying only on reports from physicians or drug companies. 36 the committee helpfully went further in its specific suggestions as to how the fda could implement a more effective post-market review process. it suggested for each drug it approved, that the fda develop a benefit and risk assessment and management plan (bramp) that it could update whenever it re-evaluates a drug's benefit-risk 35 institute of medicine of the national academies, ethical and scientific issues in studying the safety of approved drugs (2012), available at http://www.iom.edu/reports/2012/ethical-and-scientificissues-in-studying-the-safety-of-approved-drugs.aspx (as the institute of medicine describes the process, "[i]n the first stage (stage i) of the framework, fda should define the public health question that prompted the need for a regulatory decision, including identifying the specific characteristics of the drug and health problem at issue, available information about the drug, alternative treatments that are available, and plausible regulatory actions and their potential consequences. in the second stage (stage ii) of the framework, fda should evaluate the quality of evidence on both the benefits and the risks associated with the drug, including any new information that has triggered the need to consider regulatory action. the output of this stage includes estimates of the likelihood and magnitude of a drug's benefits and risks and a characterization of the scientific evidence on which the estimates are based. the third stage (stage iii) of the framework is the stage in which regulatory decisions are made and implemented. this stage involves synthesizing and integrating the estimates of benefits and risks and the quality of the evidence on which these are based (from stage ii) with the public health question (as specified in stage i); deciding on the appropriate regulatory actions, including whether further study should be required; communicating the decision; implementing the regulatory actions; evaluating the effects of the regulatory actions; and, particularly in the case of complex or difficult decisions, evaluating the decision-making process and the impact of the action taken on the public's health."). 3 6 id. 2013 509 indiana health law review profile.37 in this way, "[t]he document would serve as a guide that supports organizational adherence to the lifecycle approach, increases the transparency of fda's decisions, and fosters collaboration between fda and drug sponsors."38 explaining further the purpose of the bramp system, eric m. meslin, the director of the indiana university center for bioethics who was a member of the committee, commented that the: fda should be as serious about monitoring the safety of approved drugs on the market as it is about testing drugs before they get to the market. they already have a lot of this authority now they just need to use it.39 michelle m. mello, also a committee member, wrote a commentary in the new england journal of medicine recognizing the general difficulty of keeping human subjects of medical research safe but concluded that that "the iom committee's report makes a number of actionable recommendations that the fda can implement under its existing authority."40 iii. gathering the information about post-market adverse events a. the sponsors (drug companies) the companies that make drugs and sponsor clinical trials are, of course, interested in preventing drug interactions. indeed, part of the fda's pre-approval 37 id. 38 id. 39 institute of medicine urges improved fda monitoring of drugs after market approval, indiana university school of medicine (may 1, 2012), http://communications.medicine.iu.edulnewsroom/stories/2012/ institute-of-medicine-urges-improved-fdamonitoring-of-drugs-aft. 40 michelle mello et al., ethical considerations in studying drug safety the institute of medicine report, 367 new eng. j. med. 959, 963 (2012), available at http://www.nejm.org/doilfull10.1056/nejmhle 1207160. 510 vol. 10:2 putting patients first process4 1 requires them to conduct extensive testing in the laboratory, test tube experiments, in order to identify problems long before a patient ever takes the drug. but because of the complexity of the human body and the large number of drugs already on the market, it is not possible to discover interactions. but it is also an issue of risk assessment-sponsors must weigh the cost of doing more and more testing against the likelihood of an adverse event occurring. as one commentator explains, "[w]ill we catch all drug interactions before marketing? almost certainly not." but "[s]hould we try to catch all of them, or proceed with the knowledge that one is going to slip by occasionally? that is a question for high-level risk-benefit-cost analysis within the pharmaceutical industry, with input from regulatory agencies." 42 although the fda's center for drug evaluation and research (cder) has the final authority to approve all drugs in the united states it does not often conduct the clinical trials which produce the data on which its decisions of the drug's safety and efficacy are based. that is the job of the sponsor.43 instead, once clinical trials are completed, the fda "reviews the company's data and proposed labeling" to determine if the "drug's health benefits outweigh its own 41 see generally u.s. department of health & human services: food & drug administration center for drug evaluation and research (cder), guidance for industry drug interaction studies-study design, data analysis, implications for dosing, and labehng recommendations (2012), available at http://www.fda.gov/downloads/drugs/guidancecompliance regulatorylnformation/guidances/ucm292362.pdf. 42 chris bode, the nasty surprise of a complex drug-drug interaction, 15 drug discovery today 391-39 (2010) http://dx.doi.org/ 10.1016/j.drudis.2010.02.013. 43 see bernice schacter, the new medicines: how drugs are created, approved, marketed, and sold (2006) at 9; silence is not the best medicine: requiring disclosure of clinical trial data for abandoned drugs, 33 j. legal medicine 571, 573 (2012) (defining clinical trials as "a structured set of trial-and-error experiments attempting to determine how a drug interacts with the human body") fda: development & approval process (drugs), http://www.fda.gov/ drugs/developmentapprovalprocess/default.htm ("the center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards."). 5112013 indiana health law review risk."44 this is because today, the drug sponsors are likely to either conduct the trials themselves or oversee the process very closely. 45 some commentators have been very critical of the growing role sponsors play in funding clinical trials and then publishing the results in medical journals which they effectively control. according to former medical journal editor richard smith, "[a]ll journals are bought-or at least cleverly used-by the pharmaceutical industry." 46 others think the substantial financial resources pharmaceutical companies bring to the trials improve the quality of the information available. 47 it is the sponsors who develop the protocols under which the drugs are tested, pay the physicians and medical centers involved in the clinical trials, and analyze the data themselves. 48 then, when the results are positive, they write the journal articles which introduce the drug to the practicing physicians who will prescribe them to patients. despite recent efforts to make the clinical trials process more transparent, a drug's sponsor still has no obligation to provide the fda with all the information it has gathered during the course of premarket drug development and clinical trials.49 there are at least three major categories of information that a sponsor does not have to disclose. as a private company, a pharmaceutical company is entitled to keep its drug development process confidential until it decides to initiate 44 id. 45 fazal khan & holloway supra note 13 at 422 ("pharma's control over the clinical-trial process results in a lack of transparency and, consequently, an unsafe environment for american consumers. pharma retains this control due to the monetary support they provide academic institutions, unaffiliated medical centers, and private contract research organizations (cros).") (emphasis added). 46 harriet washington, flacking for big pharma, american scholar (summer 2011), http://theamericanscholar.org/flacking-for-bigpharma/. 47 see generally khan and holloway, supra note 13. 48 see, e.g., barbara j. evans, 85 notre dame l. rev. supra note 4 at 476-525; efthimios parasidis, patients over politics. addressing legislative failure in the regulation of medical products, 2011 wis. l. rev. 929, 948-53. 49 fact act, s. 467, 110th cong. (2007), available at http://www. govtrack.us/congress/bills/109/s470#summary/1ibraryofcongress. 512 vol. 10:2 putting patients first the process of applying for permission to market the drug in the united states.50 at that point it is required to both file an investigational new drug application with the fda and register the trial in a publically available database. 51 although there are laws requiring the disclosure of clinical trials to the public, in fact there are no penalties for nondisclosure. a washington post article written in 2004 suggested based on the few drug company trials in the registry that most sponsors were simply violating the law. 52 more recent data does not document much change. moreover, sponsors can and usually do require that doctors and scientists outside of their own companies who are involved in conducting the clinical trials sign strict confidentiality agreements.53 failing to report the existence of, let alone the results from, unsuccessful clinical trials is only one of the ways in which sponsors withhold negative information from the fda. 5 4 specifically, these non-disclosures include omitting 50 see federal food, drug, and cosmetic act of 1938, 21 u.s.c. § 355 (2006); 21 c.f.r. § 312.22(a) (2011) (outlining general requirements for ind submission). see also bernice schacter, supra note 43 at 7 ("before clinical trials on a new drug may begin (i.e., before the drug or biological may be shipped across state lines the sponsor must file an ind (investigational new drug application) with the fda."). see 21 c.f.r. §§ 312.22(a), 312.3(b) (detailing process for submitting an ind). 51 food and drug administration amendments act, pub. l. no. 110-85, 121 stat. 823 (2007), 42 u.s.c. §282(j)(3)(b)(i). 52 shankar vedantam, drugmakers prefer silence on test data: firms violate us. law by not registering trials, wash. post, july 6, 2004, at al. 53 khan & holloway, supra note 13 at 421. 54 wendy wagner & david michaels, equal treatment for regulatory science: extending the controls governing the quality of public research to private research, 30 am. j. l. & med. 119, 126 (2004) ("finally and perhaps most serious is the ability of sponsors to suppress research when the results are adverse to their interests. unlike fraud, suppressing adverse results can sometimes be done with discretionary judgments that are not illegal. for example, sponsors can abort research before it is completed, and base this decision on limited resources or some purported design flaw in the study. for research that is completed, sponsors can still justify withholding the results based on discretionary judgments that the research design or reporting was incomplete or flawed in some way or that follow-up research is needed to confirm or validate the findings."). 5132013 indiana health law review bad results from the final data analysis, altering the data obtained during the clinical trials so that it is more favorable, or suppressing indications for concern that arose during clinical trials.55 a very well publicized example of came to light in a lawsuit alleging injuries from glaxosmithkline (gsk)'s drug avandia. as professor rodney miller summarizes, "[e]vidence further suggested that gsk conducted an earlier safety study that identified the cardiac risks at issue, but suppressed the data and did not submit it to the fda."5 6 another form of deliberate suppression comes earlier in the process when designing a research protocol. while the fda can review the characteristics of the patients entered into the clinical trials that produced the results submitted with the petition the sponsor does not have to provide the information used to develop the protocols.5 7 therefore, if preliminary research 55 joanna k. sax, protecting scientific integrity: the commercial speech doctrine applied to industry publications, 27 am. j.l. & med. 203, 204 ("further, pharmaceutical companies may suppress negative results, change design studies, or halt studies early if they think the results may not be positive.") (emphasis added); see also catherine deangelis, the influence of money on medical science, 296 jama 996 (2006) (reporting instances of suppression of negative research data). 56 miller supra note 2 at 433 (citing gardiner harris, drug maker hid test data, files indicate, n.y. times, july 13, 2010, at al). see also bernard lo, the future of conflicts of interest: a call for professional standards, 40 j. of l., med. & ethics 441, 442 (examples from "several recent industry-sponsored clinical trials [in which there were] serious deviations from accepted researched standards [which] biased evaluation of the risks and benefits of study drugs"). 5 see marcia angell, the truth about drug companies 906 (2004) (describing the clinical trial process); adriana petryna, experimentality: on the global mobility and regulation of human subjects research 30 political and legal anthropology review 288 (2007) (the author recounts a personal conversation with an informant who explained to her that when the fda staff reviews an application. "'they are only looking for data on safety and efficacy and how protocols are arranged and statistics are analyzed."' another source who was an fda reviewer "likened his role to that of an air traffic controller. air traffic controllers analyze information 'that's available to them and make recommendations that can be acted on . . . ."' as he explained, 'the fda reacts upon 'evidence of,' not the logic of how you got there." (emphasis in original). that is, its reviewers will rarely go beyond their immediate tasks to ask where studies took place or about 514 vol. 10:2 putting patients first showed that a drug intended to lower blood sugar tended to cause heart attacks in a specific sub-population of potential patients, the sponsor could exclude that population from its study. this is something the fda would probably notice because it requires sponsors to identify potential groups of patients and provide the information relevant to that pool. if the fda finds the information inadequate it can require that the sponsor collect more data or it can require that the absence of data be included on the drug's label.5 8 however, and the sponsors are aware that once approved, it is likely that the product can be prescribed to any patient by any licensed physician for any reason. 59 also, there is no requirement that when rules regarding clinical trials change sponsors go back and acquire this kind of information for drugs already on the market. thus, a relatively recently approved drug like lisinopril, which treats high blood pressure, has extensive information about its clinical trials. "black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to monotherapy than non-black patients,"60 but an older blood pressure medication like serpalan makes no mention of racial differences. 61 extending whistleblower protection to company employees would increase the channels of information through which information of concerns arising during clinical trials could reach physicians and regulators before the circumstances under which the data were derived. this instrumentalism, in the end, strengthens the hand of arbitrage and weakens the fda's ability to assess drug safety problems. as he points out, the logic of how you got there is the crucial determining logic of patient safety and harm.") (emphasis in original). 68 see e.g., astrazeneca, zestril (lisinopril), accessdata.fda.gov, http://www.accessdata.fda.gov/drugsatfdadocs/label/2009/019777s0541b 1.pdf ("the protocol excluded patients with hypotension (systolic blood pressure <100 mmhg), severe heart failure, cardiogenic shock, and renal dysfunction (serum creatinine >2 mg/dl and/or proteinuria > 500 mg/24 h)."). 59 see generally khan and holloway, supra note 13. 60 see astrazeneca, supra note 58. 61 medline plus, http://www.nlm.nih.gov/medlineplus/druginfo/ meds/a601107.htm1 (last visited may 12, 2013). 2013 515 indiana health law review they emerge as major sources of adverse events. 62 this includes information from research scientists about issues that emerge during testing, from pharmaceutical company employees and executives who learn of problems in the process of constructing petitions for approval of the drug and its label, and from the pharmaceutical company representatives who have direct contact with prescribing physicians. b. getting information from health care providers 1. prescribing physicians the first line of defense in protecting the public from emerging dangers of newly approved drugs has to be the physicians who prescribe them. they are in the best position to learn of problems experienced by the patients. i propose that healthcare providers be brought more actively into the process of being alert to emerging problems from newly approved drugs by requiring them to report what they see. this reporting requirement should include any decision to stop prescribing a drug either because it was not effective or because of an emerging side effect. although this may seem burdensome, in fact most prescribing physicians receive weekly visits from drug sponsors and can easily meet their obligations by reporting the information, which in turn the sponsor would then be required to report to the fda. after a drug or device is approved, the sponsor's efforts shift from the fda approval process to marketing their products directly to the physicians who will prescribe them to patients. 63 once the 62 see lan ayers, information escrows, 111 university of michigan law review 145, 193 (2012) (proposing the creation of "information escrows" to counter the problem of physicians' and patients' reluctance "to submit voluntary [adverse drug events] reports because they lack incentive to report and fear negative repercussions or embarrassment if prescription error or patient noncompliance is blamed."). 63 joshua weiss, medical marketing in the united states: a prescription for reform, 79 geo. wash. l. rev. 260, 261 (2010) ("on average, the drug and medical device industries spend over $20,000 per 516 vol. 10:2 putting patients fist 5 fda approves a drug or device is then that it becomes available for any physician to prescribe to any patient. 64 before approval, patients could only access the product through physicians who were also conducting the preapproval clinical trial. 65 while these research-physicians were likely to be experts in the condition which the drug or device was intended to treat, for example cardiologists studying a new blood pressure drug, the physicians prescribing it are for more likely to be generalists. 66 regardless of specialty, the drug or device will be as new to them as to the patient. although the fda approves of the extensive advice to prescribing physicians, which are called 'labels,' in fact many physicians get their information directly from the drug company's own representatives who come directly to their offices. 67 doctor each year on marketing efforts that include gifts, meals, travel, consultancy fees, and continuing medical education programs. the reach of medical marketing has grown so broad that one recent survey reported that ninety-four percent of physicians have received some form of benefit or payment from the drug and device industries."). 64 glaxosmithkline's $3 billion whistleblower settlement has paid for one of america's most expensive failed corporate internal investigations, qui tam whistleblowers' attorneys say, red orbit (july 2, 2012), http://www.redorbit.com/news/health/112649398/ glaxosmithklines-gsk_3_billionwhistleblowersettlementhas-paidjfor -one/. 65 see trudo lemmens and candice telfer, access to information and the right to health: the human rights case for clinical trials transparency, 38 am. j. l. & med. 63 (2012). 66 joshua weiss, medical marketing in the united states: a prescription for reform, 79 geo. wash. l. rev. 260, 267 (2010) ("the gifts, payments, and meals provided by drug and device companies create a significant, yet unconscious, desire to reciprocate among practitioners. 'while medical professionals might believe themselves to be 'more rational and critical' than the average person, the success of pharmaceutical marketing illustrates that physicians are as susceptible to target marketing as others."') (emphasis added) (quoting dana katz et al., all gifts large and small, am. j. bioethics, summer 2003, at 40-41). 67 id. at 261-262 ("drug companies flood doctors' offices with branded trinkets-everything from paper and pens to mugs and mouse pads-in an effort to push the latest prescription medicines. under an educational guise, paid and highly trained sales representatives encourage physicians to prescribe more products by bringing food and 2013 517 indiana health law review estimates of how much companies spend on marketing run into the multi-billions. 68 this marketing is highly effective even though physicians often deny their own susceptibility. it is these prescribing physicians who will have the most information about problems patients suffer after the drug is prescribed. for that reason, one of the most important sources of information about emerging postmarket concerns with a prescription drug is the prescribing physician herself. first, because this is her patient she is most likely to be the one monitoring the effects of the drug. second, in a large sense, if she has begun prescribing this drug to one patient it is reasonable to assume that she is prescribing it to others too and, depending on whether hers is a general or specialized practice, may well soon be following many patients. since the same pharmaceutical representatives visit the same doctors, they are in the best position to hear of problems. as important as it is to bring information from physicians to the fda for analysis, leading bioinformatics specialists bethany percha and russ b. altman explain that "we cannot realistically expect practicing physicians to notice and document most ddis on their own." 6 9 this is because, "[p]atients who take multiple drugs are often afflicted with multiple comorbidities, and it is difficult to determine whether adverse events are the result of side effects from a single drug, interactions between two or more drugs, or exacerbations of the patient's underlying disease(s)." 70 further, "[t]he number of patients on a particular drug combination, especially within a single practice or hospital, may be small, preventing physicians from recognizing patterns of interactions within their own patient cohorts."7 ' also, prescribing physicians may be only freebies to doctors' offices, a practice known as "detailing.") (footnotes omitted). 68 marcia angell, the truth about drug companies: how they deceive us and what to do about it 122 (2005) (estimating $54 billion in marketing expenditures for 2001). 69 see generally percha and altman supra note 3. 70 id. 71 id. 518 vol. 10:2 putting patients first one of many health care providers a patient taking a newly prescribed drug sees. 2. other health care providers since adverse events can take many different forms, a patient experiencing a problem may not contact the prescribing physician. instead, he or she may mention the problem to another health provider, may visit a walk-in clinic, or even an emergency room. 72 moreover, while physicians and hospitals are increasingly moving towards interoperable medical records, the goal of complete interoperability in the united states has not yet been reached. thus, important information still has to come from the patient himself who may not be able to give an accurate chronology of when an individual medication was prescribed. the result can be serious and often preventable injury.73 adverse events caused by drug interaction are a particular problem in the emergency room because the treating physicians are less likely to have access to the patient's medical records. without access to a patient's 72 popularity of "walk-in" retail health clinics keeps growing: poll (jan. 7, 2013), http://www.harrisinteractive.com/newsroom/ pressreleases/tabid/446/ctl/readcustom%2odefault/mid/1506/articleld/ 1134/default.aspx (last visited june 23, 2013) (harris poll finding "twenty-seven percent of all adults surveyed said they have used" walkin clinics with "40 percent of adults aged 25-to 29" stating they "had used a retail or work-based clinic . . . ."); see also rachel 0. reid, j. scott ashwood, mark w. friedberg, ellerie s. weber, claude m. setodji and ateev mehrotra, retail clinic visits and receipt of primary care, 28(4) j. gen. intern. med. 504, 511 (2012), available at http://link.springer.com/content/pdf/10.1007%2fs11606-012-2243-x.pdf (expressing concern that patients are increasingly visiting walk-in clinics rather than a primary care physician). 73 katja m. hakkarainen, khadija hedna, pax petzold and staffan hagg, percent of patients with preventable adverse drug reactions and preventability of adverse drug reactions-a meta analysis, plos one 7(3): e33236. doi:10.1371/journal.pone.0033236 (2012), available at http://www.plosone.org/article/fetchobject.action?uri=info%3adoi%2f10 .1371%2fjournal.pone.0033236&representation=pdf ("this metaanalysis demonstrates that padrs are a significant cause of morbidity among outpatients and that roughly half of all adrs among adult outpatients and inpatients may be prevented."). 5192013 indiana health law review medical records a health care provider out of state or across town may have no knowledge that the presenting problem is a side effect of a recently prescribed drug. while providers are aware of many interactions and usually ask about them in a history, they are less likely to recognize a problem caused by a new drug. it is often only by reviewing large amounts of data that patterns of drug side effects emerge. 74 for example, if a patient who receives a prescription for a new cardiac medication begins visiting an orthopedist it might signal the emergence of circulation issues instead of mere leg pain. finally, patients may present emergency rooms with issues that may or may not be immediately attributed to the new drug. for these reasons it is important to track all contacts between a patient taking a new drug and the health care system. this includes patterns of office visits by patients who have begun taking a drug new on the market. it also includes pattern of prescriptions. currently, a physician who begins to routinely prescribe stomach acid reducing drugs when she prescribes a new cholesterol medication is under no obligation to report this to the fda and she may not immediately recognize the emerging pattern. another issue involving all physicians is their potential reluctance to report adverse events for fear of suffering retaliation from the pharmaceutical companies. 75 unfortunately this is not uncommon. there are many documented cases of pharmaceutical companies engaging in deliberate activities to discredit physicians who they 74 john markoff, unreported side effects of drugs are found using internet search data, study finds, new york times (march 6, 2013) http://www.nytimes.com/2013/03/07/science/unreported-side-effects-ofdrugs-found-using-internet-data-study-finds.html?_r-0&adxnnkl&adxnnlx1372008096-5ymen+ntoph54l2q91qbwa (describing study of web searches by patients taking newly approved drugs which revealed side effects unknown to the fda) (last visited june 23, 2013). 75 see geneva campbell (comment) snitch or savoir? how the modern cultural accpetance of pharmaceutical company employee external, 15 university of pennsylvania journal of business law 565, 578-580 (2013) (describing laws providing protection for employees of pharmaceutical companies). 520 vol. 10:2 putting patients first perceive as enemies. tactics a pharmaceutical company might employ range from excluding physicians from lucrative consulting contracts to a more general campaign intended to reduce employment opportunities. 3. pharmacies and pharmacists another important source of information for issues that arise post-approval is the pharmacy where a patient goes both to pick up prescription drugs and to self-medicate with drugs available without a prescription. these are often described as over-the-counter or otc drugs. 76 at the pharmacy level, the fda can make use of existing technology to monitor the pharmacy purchases by the patient who has been prescribed a new drug. 7 a littlestudied area but one that raises many concerns is the interaction among all the substances ingested by an individual patient. the array of non-prescription medications and dietary supplements available to the american public in an ordinary drug store or supermarket is substantial. a recent example of how significant these interactions can be comes from studies conducted by academic researchers, not pharmaceutical companies, such as the effects of grapefruit juice in altering the way a variety of drugs are absorbed into the blood stream. in february 2012, the fda itself acknowledge the issue by 76 62 cath.u.law rev. at 436 77 see tradelink edi enterprise edition, softhealthcare.com, http://www.softcarehealthcare.com/pdf/casestudy-healthcanada.pdf (last visited april 20, 2013) ("integrated its over-the-counter drug monitoring system with tradelink edi management system and edi services provided by softcare ec inc. for the monitoring of retail sales of over-the-counter drugs."); see also national precursor log exchange, http://www.nplexservice.com/ (last visited april 20, 2013) ("pharmacies across the country are using the nplex e-tracking solution to not only track the purchase of products containing pseudoephedrine, but also to ensure compliance with federal pseudoephedrine tracking laws, and help law enforcement track down individuals who purchase over legal limits."); ez-sign, hcc-care.com, http://www.hcc-care.com/_products/sigcapture.aspx (last visited april 20, 2013) (helping pharmacies to meet all regulatory requirements for otc sales tracking). 2013 521 indiana health law review publishing a consumer advisory listing six major categories of drugs which could have dangerous effects if consumed with grapefruit juice. these include cholesterol lowering statins, blood pressure medications, anti-anxiety drugs, anti-arrhythmia drugs, anti-histamines and anti-organ rejection drugs.78 c getting information from patients another source of information regarding adverse events is patients themselves. as professor rodney miller explains in pointing out the short-comings of any post-market surveillance system, "discovery of 'adverse effects' will always lag behind the injuries that make their detection possible. thus, a drug's first subscribers unwittingly serve as participants in the drug's extended 'clinical trial,' but without the disclosures and protections normally afforded to such participants." 7 9 the same fda medwatch program that facilitates reports from health professionals and regulated industry is also available for patients to "voluntarily report a serious adverse event, product quality problem, product use error . . . that you suspect is associated with the use of an fda-regulated drug, biologic, or medical device . . . ."so the form is five pages long, and resembles a tax return. it can be completed or submitted by mail, fax or online.81 patients receive on-line information about prescription drugs from sources sponsored by the pharmaceutical companies and from those with no connection to it. the fda regulations regarding a 78 grapefruit juice and medicine may not mix, fda.gov (feb. 2012), http://www.fda.gov/downloads/forconsumers/consumerupdates/ ucm292839.pdf. 79 miller supra note 2 at 436. sofda.gov, reporting serious problems to the fda, http://www.fda. gov/safety/medwatchlhowtoreport/default.htm. 81 see generally, medwatch consumer voluntary reporting (form fda 3500b), available at http://www.fda.gov/downloads/aboutfdal reportsmanualsforms/forms/ucm349464.pdf; see also medwatch consumer voluntary reporting (form fda 3500b), https://www. accessdata.fda.gov/scripts/medwatch/medwatch-online.htm (providing an online-only option for filling out the form). 522 vol. 10:2 putting patients first pharmaceutical company's obligations to report information about adverse events through its own sponsored sites was drafted in 2001, well before the advent of social media. the current obligations only require reporting when the company has: (1) [a]n identifiable patient; (2) [a]n identifiable reporter; (3) [a] suspect drug or biological product; and [4] an adverse experience or fatal outcome suspected to be due to the suspect drug or biological product." 82 in other words, there is no obligation to report any information posted anonymously. as commentator bronwyn mixter advised in bna's health care daily report, "this leaves the industry somewhat off the hook for reviewing internet sites that they do not sponsor."83 in the absence of guidance, the response of the pharmaceutical industry has been to retreat from social media in order to avoid acquiring information about potential adverse events. 84 as american medical news reports: in august 2011, many pharmaceutical companies shut down facebook pages82 u.s. department of health & human services: food & drug administration center for drug evaluation and research (cder), supra note 41 at 7. 83 stuart l. friedel & joseph a. sena jr., bloomberg bna: social media law & policy report 4 (2012), available at http://www.dglaw. com/images-user/newsalerts/friedelsenapharmachallenges.pdf, see also bronwyn mixter, social media use presents challenges for drug manufacturers, experts say, bloomberg bna (october 4, 2012), http://www.bna.com/social-media-presents-nl7179870033/ ("pharmaceutical companies fear that encouraging consumers to post publicly on social media sites will inundate them with reports of adverse drug experiences, which they may be required to file with the fda or risk potential liability"). 84 audet & partners, llp, fda grapples with social media, jd supra law news (apr. 18, 2013), http://www.jdsupra.com/legalnews/ fda-grapples-with-social-media-96820/. 5232013 indiana health law review especially those devoted to particular drugs-after facebook stopped giving them the option to shut off public comments on those pages. the companies cited a lack of fda guidance on how to handle social media comments as their reason for shutting down the pages. most vowed to keep their pages shut down until the fda provided guidance on how comments be handled. 85 the result is that pharmaceutical companies have no real duty to either correct misinformation or report adverse events if they, themselves, have not initiated the communication. thus, a spokesman for an advertising agency representing pharmaceutical companies recently commented, "'[ilt is not appropriate to simply bury your head .... the risk is not being aware of a potential public health risk' if people are distributing incorrect information about drug products," head burying is a legal option.86 d. investing in monitoring technology reviewing patients' medical records will reveal information about possible adverse effects beyond what could be achieved by waiting for any individual patient to file a complaint. technology exists to monitor the first generation of the public who are prescribed a new medication for potentially serious medical events, which 85 stuart l. friedel and joseph a. sena, pharma challenges. adverse event reporting and social media (2010), http://about. bloomberglaw.com/practitioner-contributions/pharma-challenges-adverseevent-reporting-and-social-medial ("facebook had initially granted pharmaceutical companies the option to block public commenting due to the industry's highly regulated nature and its fears over adverse drug experience reporting requirements. in august 2011, facebook revoked that exception and, as a result, several notable pharmaceutical companies (e.g., johnson & johnson, astrazeneca) took their facebook pages down altogether."). 86 bronwyn mixter, social media use presents challenges for drug manufacturers, experts say, bloomberg bna (october 4, 2012), http://www.bna.com/social-media-presents-nl7179870033/. 524 vol. 10:2 putting patents first may be related to the drug, device or biological. 87 this monitoring should be of both medical and pharmacy records. a fully functioning interoperable system of electronic health records could track doctor's visits wherever and whenever they occur for references to symptoms or complaints, which could be an early sign of harm. it could also track pharmacy visits for purchases of non-prescription medications such as antacids or muscle soreness, which also may indicate adverse affects. moreover, this kind of monitoring could catch the possible masking of symptoms through selfmedication. linking monitoring systems to research subjects or first generation consumers is well within the abilities of currently available technology. pharmacies already track non-prescription purchases because, until recently, they were reimbursable under some employee benefit plans.88 linking pharmacy records to a patient's already existing medical records would be a powerful step towards monitoring post-market adverse events. 89 because this software will have access to complete medical records it will be possible to identify specific factors which correlate with side-effects such as co-morbidities or other drugs being taken. in time, this may well rise to the level of monitoring 87 yihan guan & yiliang jin, fast detection of risk signals in post-marketing drug surveillance using costs in claims data: a machine learning approach, (dec 9, 2010), http://cs229.stanford. edulproj20lo/guanjin-fastdetectionofrisksignalsinpostmarketing drugsurveillance.pdf (describing an algorithm to detect side effects). 88 cf electronic monitoring of asthma me use may boost adherence, drugs.com (june 18, 2010), http://www.drugs.com/news/ electronic-monitoringasthma-med-may-boostadherence-25080.html (stating that there is a pilot program to measure adherence with inhaled corticosteroids for asthma attacks based on how often prescriptions are fulfilled); see also kendall ho, achieving patient safety through information technology-an emerging frontier becomes mainstream, touchbriefings.com, http://www.touchbriefings.com/ pdf/1965/ho.pdf (last visited apr. 25, 2013). 89 see nicolas p. terry and leslie p. francis, ensuring the privacy and confidentiality of electronic health records, u. ill. l. rev. 681, 687-688) (2007) (discussing the benefits and mechanics of linking medical records from different hospitals and providers. so far, no one has proposed linking pharmacy records to medical records.). 5252013 indiana health law review the effectiveness of newly released drugs depending on specific genetic characteristics of future patients. e. helping the fda make use of the information it receives the last on the list of people and entities most likely to learn of adverse effects from a recently approved drug or device is the fda. the fda's limited oversight after a drug or device is approved and released on the market has been the topic of considerable and sustained criticism. 90 in 2006, the institute of medicine issued two highly critical reports which cite "a range of problems including chronic underfunding, insufficient regulatory authority, staff conflicts, and poor management . . . [calling] for sweeping changes in the way the . . . [fda] monitors drug safety."91 the reports make specific recommendations for measures to gather information about potential harm as soon as possible from the insiders who have spoken with the doctors prescribing the drugs and the patients taking it.92 90 see generally, jennifer s. bard, what to do when you can't hear the whistleblowing: a proposal to protect the public's health by providing whistleblower protection for medical researchers, 9 ind. health l. rev. 1, 39-46 (2012) (describing deficiencies in current postmarket surveillance process); see also rebecca dresser & joel frader, off-label prescribing: a call for heightened professional and government oversight, 37 j.l. med. & ethics 476, 482 (2009) ("the fda has accepted the results of trials involving as few as eight people as adequate evidence of safety and effectiveness."). 91 bridget m kuehn, iom: overhaul drug safety monitoring, 296 jama 2075 (2006), available at http://jama.jamanetwork.com/ article. aspx?articleid=203870. 92 see jackie kmetz, visible technologies, pharmaceutical industry special report: adverse event reporting in social media (2006), available at http://www.visibletechnologies.com/ resources/white-papers/adverse-events/ (last visited april 30, 2013) (noting only 1 in 7 actual adverse events from in-hospital administration of both prescription and over-the-counter drugs led to a posting to a system designed to track in-hospital adverse events t under the criteria established by the fda and suggesting that approximately half would trigger a report if social media listening is utilized); see also agency for healhcare research and quality, united states dep't of health & human services, publ. # 01-0020, reducing and 526 vol. 10:2 putting patients first the fda is well aware of this issue and exercises its legal authority to review products, require label changes or even ban products from the market. however, recent lawsuits in which plaintiffs have brought forward credible evidence that drug manufacturers (the "sponsors") have deliberately concealed known dangers have created increased interest. the public, the media, and most notably the institute of medicine have all called on the fda to do more post-market review. 93 yet the resources available to the fda have not materially changed. 94 the fda faces a difficult challenge in balancing the interest of the sponsors to recoup their investment by getting new products on the market quickly and that of the public which deserves a better understanding of the limits to which the fda, the sponsor or even the prescribing physician know of the risks when the product gets used in real life.9 5 preventing adverse drug events to decrease hospital costs (2001), available at http://www.ahrq.gov/qual/aderia/aderia.htm (last visited april 30, 2013) ("adverse drug events (ades) result in more than 770,000 injuries and deaths each year and cost up to $5.6 million per hospital, depending on size. many ade injuries and resulting hospital costs can be reduced if hospitals make changes to their systems for preventing and detecting ades."); see also adverse event reporting & drug safety, patients like me, http://www.patientslikeme. com/help/faq/adverse%20event%2oreporting%20&%2odrug%2osafety (last updated april 16, 2013) (last visited april 30, 2013) ("while there is much information learned from clinical trials, they do not fully reflect the way a medical product is used in real life. through the experiences of patients like you, manufacturers of drug and medical products can expand their understanding of a product's safety profile. in turn, manufacturers are required to inform regulators such as the fda about these experiences."). 93 see pray & robinson note 110, infra and accompanying text. 94 see nicolas j. plionis, the right to access experimental drugs: why the fda should not deprive the terminally ill of a chance to live, 16 wm. & mary bill rts. j. 901 (2008) (reviewing the criticism that the fda does not do enough to expedite the availability of investigational new drugs to those like abigail burroughs who unsuccessfully claimed a constitutional right to access potentially lifesaving chemotherapy). 95 see percha and altman supra note 3 at 178 "we cannot realistically expect practicing physicians to notice and document most ddis on their own. patients who take multiple drugs are often afflicted with multiple comorbidities, and it is difficult to determine whether 2013 527 indiana health law review it is beyond the scope of this article to advise the fda specifically how it could better use bioinformatics to analyze the data it is already getting, let alone the additional data that may come in based on adoption of the suggestions in this article. however, it is familiar with the concept of contracting with private companies for data mining services 96 and there is already an industry in the private sector devoted to using their own, proprietary, software programs to analyze the fda's own data. 97 the central premise of this article is that the fda should be using all its powers to develop systems intended to reduce the harm suffered by patients from problems that only emerge after a product is on the market. but within the reality of the fda's funding base, it suggests that among these powers is the ability to shift the cost for these systems to those who stand to benefit financially from the product's success: its sponsor. another thing the fda could do is keep in closer contact with the drugs and devices used in the united states that are usually also distributed throughout the world. many jurisdictions have their own adverse event tracking systems, but so far there is no systematic structure for cooperation. 98 some of the most serious post-approval adverse events are the result of side effects from a single drug, interactions between two or more drugs, or exacerbations of the patient's underlying disease(s)." 96 jeryl bier, fda seeks 'data mining and targeting software', the weekly standard (jun 20, 2013) http://www.weeklystandard.com/ blogs/fda-seeksdata-miningand-targetingsoftware_736829.html 97 adverseevents.com, http://www.adverseevents.com/about faq. php ("adverseevents utilizes a data sourcing method called rxfiltertm , providing precise, standardized solutions for an accurate view of drugs safety issues reported to the fda. rxfilter is a proprietary 17-step data refinement process developed by adverseevents, inc. that standardizes and normalizes the aers database. combining complex computer algorithms with hands-on data analysis by highly trained researchers, the rxfilter process is the most thorough optimization procedure ever applied to the fda's drug safety database to accurately measure and track adverse events associated with medications reported to the fda."). 98 monitoring and reporting adverse events app. 71 (2003), available at http://www.icssc.org/documents/resources/aemanual2003 appendicesfebruary 06 2003%20final.pdf ("a protocol for a clinical trial must adhere to international conference on harmonisation (ich) 528 vol. 10:2 putting patients first adverse events, like the fetal harm done by thalidomide, could have been avoided by keeping a closer watch on the effects of a drug released earlier, or even at the same time, in another country. f effective solutions 1. expanding whistleblower protection this article asserts that the burden for creating early detection systems, including whistleblower protection, should be on the drug companies themselves because they are the ones with the greatest financial interest in the drug's success and the greatest access to information about potential dangers. moreover, congress has already identified extending whistleblowing protection for employees of pharmaceutical companies as an important method of ensuring compliance with federal anti-fraud laws such as dodd-frank 99 and the affordable care act.100 whistleblower protection must, then, extend to every individual who may come into contact with information about dangers to the public's health. this protection must be geared to what these people know, substance based, not how they know it, job title based.101 this section provides some suggestions for how that change should occur. e6: good clinical practices (gcp), section 6, and must address.. .procedures for assessing and reporting adverse events . . . ."); isha patel & r. balkrishnan, medication error management around the globe: an overview, 72 indian j. pharmarcy sci. 539, 539 (2010) (stating that "there are established and effective medication vigilance systems in many developed countries. the different countries undertake activities which range from collecting information about prescriptions, surveying physicians about adverse drug events, and conducting sophisticated post-marketing surveillance studies.") 99 dodd-frank wall street reform and consumer protection act of 2010, pub. l. no. 111-203, 124 stat. 1376-2223. 10 see generally geneva campbell (comment) snitch or savoir? how the modern cultural acceptance of pharmaceutical company employee external, 15 university of pennsylvania journal of business law 565, 578-580 (2013) (describing laws providing protection for employees of pharmaceutical companies). 101 c michael m. ting, whistleblowing, 102 am. political sci. 5292013 indiana health law review 2 models of strong whistleblower protection in recent federal statutes in the last ten years, there has been significant interest by congress in extending protection to consumers from corporate fraud by developing new statutes, and amending old ones, that provide strong incentives for whistleblowers as well as greater protection from employer retaliation. the sarbanes-oxley act (sox) exceeds all previous federal whistleblower statutes by actually requiring disclosure.102 it was enacted in response to a series of public scandals in which companies' outside lawyers and accountants failed to report what was obvious fraud and wrong-doing.103 another enhancement to a whistleblowing statute is the provision of an incentive for a whistleblower such as is available in the 2010 dodd-frank consumer protection act.104 dodd-frank amends both sox1o5 and the false claims act 06 to provide greater protection against retaliation for whistleblowers. 07 rev. 249, 263 (2008) (while this article focuses on the task of bringing legal protection against retaliation, that is not to suggest that "fear of retaliation" is the only relevant factor as michael ting has developed a mathematical model identifying the key factors which affect a public employee's decision to disclose information and suggests that motivation depends on the characteristics of the organization itself so that no one set of incentives will be effective in every setting.). 102 see 18 u.s.c. §1513(e) (2012) (sox also has strong antiretaliation provisions stating that it is unlawful for any company or individual to take any action with intent to retaliate against any person, for providing truthful information to law enforcement relating to the commission of a federal offense). see also miriam a. cherry, whistling in the dark? corporate fraud, whistleblowers, and the implications of the sarbanes-oxley act for employment law, 79 wash. l. rev. 1029, 1065 (2004). 103 see, e.g., dustin d. stohler, enron's gift to hr managers, ind. emp. l. letter, jan. 2004; tom hamburger, et al., worldcom propels congress to focus on business reform, wall st. j. (june 27, 2002), http://online.wsj.com/article/sb1025131087612990560.html. 104 dodd-frank wall street reform and consumer protection act of 2010, pub. l. no. 111-203, 124 stat. 1376-2223. 105 id. at §929a. 106 id. at §1079b (expanding the definition of acts protected against retaliation to include retaliation against those associated with the actual whistleblower-qui tam relator). 107 dodd-frank wall street reform and consumer protection act of 530 vol. 10:2 putting patients first for example, companies must now prove by clear and convincing evidence that they would have terminated a whistleblower even if they were unaware of his complaints.108 these examples of increased whistleblower protection provided by federal statutes are a model of what more could be done to protect employees of pharmaceutical companies who bring forward information about a potential danger associated with a drug for which their company is either seeking approval or which is already on the market. 3. using active surveillance the burden for reporting adverse events from prescription drugs is on the pharmaceutical company, not the prescribing doctor, the issuing pharmacist or the injured patient. in contrast, hospitals that receive medicare funding are required by law to "track medical errors and adverse patient events, analyze their causes, and implement preventive actions." 109 in 2007 the institute of medicine (iom) conducted a workshop to directly consider the challenges the fda would face in the future addressing the issues of drug safety identified by the 2007 report. 110 although the workshop covered many topics, it focused considerable attention on issues of post-market review. it made several recommendations for how the fda could better use its resources to implement stronger protections. 2010, pub. l. no. 111-203, 124 stat. 1376-2223. 108 see 49 u.s.c. § 42121(b)(2)(b)(iv) (2012). see also collins v. beazer homes usa, inc., 334 f. supp. 2d 1365, 1376 (stating that employer is entitled for protection from a retaliation claim if they can show by clear and convincing evidence that it would have fired the employee regardless of their whistleblowing behavior). 109 42 cfr sec. 481.21. indeed, the tax relief and health care act of 2006, p.l. 109-432 sec 203 goes further by requiring the office of the inspector general to report directly to congress events occurring in hospitals serving medicare and medicaid patients which should never occur in a hospital ("never events"). tax relief and health care act of 2006, p.l. 109-432 sec. 203. 110 leslie pray & sally robinson, challenges for the fda: the future of drug safety, workshop summary (2007), available at http://www.nap.edu/catalog/11969.html. 5312013 indiana health law review one of the iom's conclusions was that "[t]he current system relies primarily on data collected through passive surveillance."111 it therefore recommended that it "develop and implement active surveillance of specific drugs and diseases as needed."112 it did not, however, suggest how this should be done. the workshop summary explained why the adverse event reporting system (aers) was inadequate. it noted that the aers consisted of data from three datasets: "[1] averse event data reported voluntarily through medwatch (generally by physicians, other health care practitioners, and consumers), [21 mandatory periodically reported data from product manufacturers, and [3] mandatory 7and 15-day expedited report data from manufacturers following notification of a serious and unexpected adverse event."113 however, there is no obligation on the part of manufacturers to actively seek out information about adverse events and no division of the fda is tasked with the responsibility of conducting active surveillance. as a result there are frequently long delays between the emergence of a problem and the fda awareness of it. while this passive surveillance system may be capable of detecting rare serious adverse events, it has several limitations, including profound underreporting, biased reporting, and difficulties in attributing an adverse event to a specific drug. additionally, when analyzing postmarket epidemiological data collected through passive surveillance, it is difficult to know just how many people have taken a drug (i.e., to determine a denominator), it is difficult to know how many events occurred (i.e., to determine the numerator) because of underreporting, and therefore it is difficult to conclude the rate at which an event would take 111 id. at 91. 112 id. at 92. 113 id. at 33. 532 vol. 10:2 putting patients first place (e.g., event x would occur in 1 of every 100,000 persons)."114 4. monitoring harm and protecting whistleblowers through bioinformatics the fda is aware that the future of effective monitoring for adverse events is through innovations in bioinformatics. bioinformatics is "a field devoted to the creation and application of computational methods for the acquisition, representation, retrieval, and analysis of biomedical data." 115 in 2008 it adopted the sentinel initiative, described as: a national electronic system that will transform fda's ability to track the safety of drugs, biologics, and medical devices once they reach the market . .. .[the sentinel initiative aims to develop and implement a proactive system that will complement existing systems that the agency has in place to track reports of adverse events linked to the use of its regulated products. 11 6 it is increasingly clear that much of the information the fda needs to identify possibly harmful, and previously unknown, side effects is available through data analysis. this includes both information and data bases designed to track adverse events as well as mining existing electronic sources, such as social media, for evidence of problems. for example, in a 2010 study researchers tracking the web searches of over six million users were able to find evidence that "an antidepressant, paroxetine, and a cholesterol lowering drug, pravastatin" when combined "caused high 114 id 115 russ altman, real quick: what is bioinformatics?, wordpress.com weblog (apr. 8, 2013, 3:00 pm), http://rbaltman. wordpress.com/real-quick-what-is-bioinformatics/. 116 fda sentinel initiative, fda.gov, http://www.fda.gov/safety/ fdassentinellnitiative/ucm2007250.htm (last visited apr. 22, 2013). 2013 533 indiana health law review blood sugar." 117 their methodology was to "[d]etermine people who searched for both drugs during the 12-month period" and found that searchers "were significantly more likely to search for terms related to hyperglycemia than were those who searched for just one of the drugs. (about 10 percent, compared with 5 percent and 4 percent for just one drug.)"118 but where is this information and how can the fda access it? members of the iom advisory panel had several answers to the first question and few to the second. as a first principle, in order to identify patterns of adverse events a system would have to monitor a large number of people. one member of the iom advisory committee estimated that the minimum number of people monitored in order to have sufficient statistical power would be 100 million.119 they pointed out that the federal government already tracks the health of millions of americans through medicare, the veteran's administration, the department of defense, federal employee health care and, to a lesser extent, medicaid. 120 while the government itself could decide to share this information with the fda, the bigger issue relates to the private sector. health insurance companies have long maintained their own proprietary databases of claims information, which, if accessed, could provide early indications of potential problems. 121 one way into that information is to incorporate sharing of deindentified data into the current hipaa-hitech laws that mandate nearly all hospitals and physicians to use interoperable electronic medical record systems. thus, the fda could have access to the claims health care providers are making to insurance companies rather than getting the information from the companies themselves. 117 markoff, supra note 74. see also ryen w white et al, web-scale pharmacovigilance: listening to signals from the crowd, j. am. med. inform. assoc., (jan. 13, 2013), available at http://jamia.bmj.com/ content/early/2 013/02/05/amiajnl-2012-001482.abstract. 1" markoff, supra note 74. 119 pray & robinson, supra note 110 at 37. 120 id. at 40. 121 id. at 38. 534 vol. 10:2 putting patients first finally, much of this information may well be accessible through monitoring and analysis of internet use. ours is a computerized society where information moves quickly and easily.122 in his book, the world is flat: a brief history of the twenty first century, the new york times columnist tom friedman notes that the internet has given everyone around the globe the same access to information, and we are used to conducting much of our personal and professional activities online.123 this connectivity can play an important role in overseeing the well being of both subjects of medical research and those taking newly approved drugs in two important ways. first, it can directly monitor the health of individuals who are taking a specific drug and second it can create a safe way for whistleblowers to report suspicions of wrongdoing without fear of retaliation. an anonymous reporting system obviates the need for relying on traditional anti-retaliation measures because it prevents the whistleblower from ever needing this protection. he or she can be anonymous. the best way to encourage whistleblowing and to avoid retaliation is to provide a secure channel for anonymous reporting as well as to set up self-monitoring systems that reduce the need for relying on individual reportingl 24. this technology has also been used for both public health and biodefense purposes.125 122 see thomas l. friedman, the world is flat: a brief history of the twenty first century, 153-54, 216 (2005) ("google is now processing roughly one billion searches per day, up from 150 million just three years ago. 'over a third of our searches are u.s.-based, and less than half are in english'. . . [wlhether [it's] a kid in cambodia, the university professor, or me who runs this search engine, all have the same basic access to overall research information that anyone has. it is a total equalizer . . . [in addition, as quoted by congressman rahm emanuel, former senior advisor to president clinton], we streamlined the fda's drug approval process in response to concerns about its cumbersome nature. we took those steps with one objective in mind: to move drugs to the marketplace more quickly. the result, however, has been an increasingly cozy relationship between the fda and the pharmaceutical industry."). 123 id. at 178. 124 whether or not a whistleblower is an employee, retaliation is a very real fear of individuals who criticize the pharmaceutical industry. a recent 2013 535 indiana health law review improved technology has made it possible to provide greater protection for whistleblowers. both private companies 126 and the government have adopted telephone hot lines as well as secure web sites. 127 class action lawsuit in australia, revealed corporate documents outlining a plan to discredit physicians who were criticizing vioxx. a reporter for a consumer blog who reported on the trial said, "court evidence show[ed] company employees drew up a 'hit list' of doctors, researchers, and academics who, it was felt, had to be 'neutralized' or discredited from criticizing the drug. melanie segala, how big pharma threatens its critics, wellsphere.com (jun. 08, 2009), http://www.wellsphere.com/ healthy-living-article/how-big-pharma-threatens-its-critics/703458 (reposted with permission by the author). the reporter went on to quote an email by a merck employee: "we may need to seek them out and destroy them where they live." id retaliation is a common threat in the field of medical research. in one well publicized incident, professor told the journal of the american medical association (jama), that the author of an article they had published, had an undisclosed financial tie to a drug company it put his career in danger. he claims that jama editors threatened to ban the professor from their journal and ruin his medical school's reputation if he didn't stop talking to reporters . . . jama's editors acknowledged in a march 20 editorial being upset about leo airing his concerns. they argue that publicizing unconfirmed allegations about study authors could unfairly damage reputations and interfere with jama's own investigations." see associated press, jaal4 editors allegedly threatened tipster professor raised concerns of study author's ties to drug industry (last updated march 30, 2009), http://www.msnbc.msn.com/id/29961791/ns/health-healthcare/. 125 for an example of how such a non-automated surveillance system worked in tracking the progress of h1n1 influenza from the mexican border into the united states see joseph b. mccormick, chris yan, jessica ballou, yvette salinas, belinda reininger, jennifer gay, fidel calvillo, j. gaines wilson, leonel lopez, susan p. fisher-hoch, biosecurity and bioterrorism: biodefense strategy, practice, and science (sept. 2010) vol. 8, no. 3: 233-242, available at http://www. liebertonline.com/doi/abs/10.1089/bsp.2010.0014 and http://www.osc.gov/ documents/forms/oscl2.htm. 126 fulcrum offers professional forensic accountants who can develop and monitor an individualized whistleblower reporting system to comply with the requirements of sarbanes-oxley and other state and federal laws. best practices in whistleblower system, fulcrum, http:// www.fulcrum.com/whistleblowerservices.htm (last visited may 30, 2012). 127 id. 536 vol. 10:2 putting patients first medical care in the united states is both chaotic and fragmented when compared to the single payer systems of other countries.128 as a result it can take a long time for a pattern of bad outcomes to be traced back to a particular drug.12 9 one way of solving this problem is by adopting interoperable electronic health records which are not confined to a single hospital or doctor's office but rather track an individual patient's interactions the health care system wherever and whenever they occur. this is not a new idea. however, in order for such a system to work, all entities that collect health information must invest in systems which can share the information. 5. technology to encourage information sharing the best way to encourage whistleblowing and to avoid retaliation is to provide a secure channel for anonymous reporting as well as to set up self-monitoring systems that reduce the need for relying on individual reporting.130 this 128 noam n. levey, us. healthcare system lags other countries on quality, access, l.a. times, (oct. 18, 2011), http://articles. latimes.com/2011/oct/18/news/la-heb-us-healthcare-20101018 ("the u.s. healthcare system is lagging further and further behind other industrialized countries on major measures of quality, efficiency and access to care, according to a new report from the nonprofit commonwealth fund..."). 129 luke timmerman, adverseevents.com seeks to keep track of drug side effects the way the fda never could, xconomy, sep. 27, 2011, http://www.xconomy.com/san-francisco/2011/09/27/adverseeventscomseeks-to-keep-track-of-drug-side-effects-the-way-the-fda-nevercould/ ("the current system-in which doctors voluntarily fax or e-mail forms about bad reactions they suspect are drug-related-has numerous well-documented flaws. only about 500,000 reports are sent to the fda each year, about one-tenth of the estimated number of actual bad reactions. and once reports are entered, they are littered with misspellings, misclassifications, incomplete entries, and incompatible file formats that make it extremely difficult to search the database. those barriers have made it tough for the fda, or anyone else, to spot the early warning signs of a dangerous drug until millions of people have been exposed, creating front-page scandals and highly litigious cases like the ones with the pain reliever rofecoxib (vioxx) and the diabetes drug rosiglitazone (avandia)."). 130 see segala, supra note 124. ("[a reporter for a consumer blog who reported on the trial of a recent class action lawsuit in australia on 5372013 indiana health law review technology has also been used for both public health and biodefense purposes.131 6. getting information to the fda while individual whistleblowers will likely always have a role to play in patient safety, increased integration of electronic medical records 132 offer the promise that there will also be software which automatically monitors newly released drugs for unusual or serious side-effects without relying on reporting by anyone-whether they be a plan to discredit physicians who were criticizing vioxx and the pharmaceutical industry said] court evidence show [ed] company employees drew up a 'hit list' of doctors, researchers, and academics who, it was felt, had to be 'neutralized' or discredited from criticizing the drug . . . [an email by a merck employee said] we may need to seek them out and destroy them where they live."); see also jam editors allegedly threatened tipster, nbcnews.com (mar. 30, 2009), http://www.msnbc.msn.comlid/29961791/ns/health-healthcarel (explaining how retaliation is a common threat in the field of medical research. in one well-publicized incident, a professor told the journal of the american medical association (jama), that the author of an article they had published had an undisclosed financial tie to a drug company. he then claimed that jama editors threatened to ban the professor from the journal, and ruin his medical school's reputation, if he didn't stop talking to reporters. jama's editors acknowledged in an editorial that they were upset about the professor airing his concerns, but argued that publicizing unconfirmed allegations about study authors could unfairly damage reputations and interfere with jama's own investigations.). 131 for an example of how such a non-automated surveillance system worked in tracking the progress of h1n1 influenza from the mexican border into the united states see joseph b. mccormick et al, response to h1n1 in a us. -mexico border community, 8 biosecurity and bioterrorism: biodefense strategy, practice, and science 233 (2010); see also form osc-12 information about filing a whistleblower disclosure with the office of special counsel, osc.gov, http://www.osc.gov/documents/forms/oscl2.htm (last visited apr. 22, 2013). 132 great minds think alike. see efthimios parasidis, patients over politics: addressing legislative failure in the regulation of medical products, 2011 wis. l. rev. 929, 965-966 (2011) (describing how health information technology, and specifically electronic medical records, can be used to identify potential dangers in medical products after they are on the market). 538 vol. 10:2 putting patients first whistleblowers, doctors, patients or pharmaceutical companies. these are the kinds of systems which promise to recognize patterns long before large numbers of patients are affected.133 this is consistent with the federal goal that electronic health information should serve the function of "improving health or reducing health care costs, protocol development, case management and care coordination, contacting of healthcare providers and patients with information about treatment alternatives; and related functions that do not include treatment."134 this could be a feature of the new laws requiring the development of interoperable health systems records. 135 because this software will have access to complete medical records it will be possible to identify specific factors which correlate with side-effects such as co-morbidities or other drugs being taken. in time, this may well rise to the level of monitoring the effectiveness of newly released drugs depending on specific genetic characteristics of future patients. a self-executing monitoring system overseeing newlyapproved drugs would work like a public health surveillance system which alerts responders to clusters of unusual symptoms which could indicate an outbreak of a serious disease whether natural or launched as a bio-weapon. 136 133 see e.g., sharona hoffman & andy podgurski, improving health care outcomes through personalized comparisons of treatment effectiveness based on electronic health records, 39 j. l. med. & ethics 425 (2011) (describing the prospect of improving patient care through an increased ability to compare the effectiveness of different drugs and treatment records through a study of medical records rather than conducting a separate, and expensive, new clinical trial). 134 45 c.f.r. §164.501 (2013); see also hearing before the department of health and human service's national committee of vital and health statistics subcommittee on quality, (oct. 13, 2009) (testimony of kathryn mcdonald, associate director and an investigator at stanford and the ucsf evidence-based practice center), available at http://ncvhs.hhs.gov/091013tr.htm#coordination. 135 see terry & francis, supra note 89 at 688. 136 jonathan richman, monitoring adverse events in social media for pharma's biggest brands: hopeless task or simple project, dose of digital (dec. 8, 2009), http://www.doseofdigital.com/2009/12/monitoring5392013 indiana health law review however, any new surveillance system will have its share of problems. the first is that, like any method of compiling information, the quality of the results will only be as good as the information put into them. 137 the advantage of using these interoperable health records is that the software would be scanning the real time health information from hospitals as well as doctor's offices, clinics, and other locations. it could then send warning alerts to investigatory units of the designated agency. 138 7 barriers to expanding access to information a post on the popular blog pharmalot reporting a recent case in which an employee at merck was awarded $555,000 for retaliation she suffered after refusing to use her company credit card to pay for another employee's adverse-events-social-media-pharmas-biggest-brands/ (discussing how the number of reportable adverse events is manageable and less common than people think and for many pharmaceutical companies, it would be difficult, but not impossible to do this monitoring in house, as some automatic filtering could simplify things. using call center employees, who are already trained in how to handle these issues makes sense. even the largest brands have manageable numbers of adverse events, eliminating the fear companies have that it may be a daunting task to monitor everything.). 137 there is an extensive literature on the dangers posed by electronic medical records system. see sharona hoffman & andy podgurski, meaningful use and certification of health information technology' what about safety?, 39 j. l. med & ethics 77 (2011) (discussing dangers from human input error); see also joan s. ash et al., some unintended consequences of information technology in health care: the nature of patient care information system-related errors, 2 j. am. med. informatics ass'n 104, 107 (2004); marcia m. boumila et al., prescrption data mining, medical privacy and the first amendment: the u.s. supreme court in sorrell v ims health inc., 21 annals health l. 447, 456-458 (2012) (discussing first amendment limitations on prohibiting pharmaceutical companies from accessing physician's prescribing habits). 138 this kind of monitoring of electronic medical records for incidences of bioterrorism is a well-established procedure for the united states' defense from a bioattack. see tener goodwin veenema & joanna t6ke, early detection and surveillance for biopreparedness and eid: advances in diagnostic technologies, medscape, http://www. medscape.com/viewarticle/528307_5 (last visited april 22, 2013). 540 vol. 10:2 putting patients first unauthorized expenses, generated dozens of anonymous comments about the prevalence of retaliation in the pharmaceutical industry. 139 as commenter pharmarep wrote: everyone that is in the pharma business knows that retaliation from pharma is a way of life. period, end of story. and for those who have never had to deal with retaliation from a company they should be thankful. it is a treacherous form of brutality and abuse that no-one would wish on someone. it's high time that this industry gets what is deserved when they treat people like this. she should have asked for millions in punitive damages. 140 another blogger who used the pseudonym "doc" wrote, "[als one who has personally had to defend themselves against big pharma, they are brutal. anyone who thinks these corps will not try and get rid of those who rock the boat is living in a dream world."141 nor are fda employees immune from retaliation by their own agency. 142 fda 139 ed silverman, former merck rep wins lawsuit over retaliation, pharmalot (jan. 18, 2011), http://www.pharmalot.com/ 2011/01/former-merck-reps-wins-lawsuit-over-retaliation/. 140 pharmarep, comment to former merck rep wins lawsuit over retaliation, pharmalot (jan. 18, 2011, 1:20 pm), http://www. pharmalive.com/former-merck-reps-wins-lawsuit-over-retaliation/. 141 doc, comment to former merck rep wins lawsuit over retaliation, pharmalot (jan. 18, 2011, 1:20 pm), http://www. pharmalive.com/former-merck-reps-wins-lawsuit-over-retaliation/; see also steve green, las vegas man wins $1.868 million in employment age, retabation suit, las vegas sun (march 18, 2012), http://www.lasvegassun.com/news/2012/mar/18/las-vegas-man-wins-1868million-employment-age-ret; see also francesca grifo, vioxx shows what happens when the drug safety system breaks down, union of concerned scientists (march 29, 2012), http://blog.ucsusa. org/vioxxshows-what-happens-when-the-drug-safety-system-breaks-down. 142 bryant furlow, us fda monitored whistleblowers' computers and emails, 13 lancet oncology 231 (2012), available at http://www.thelancet.com/journals/1anonc/article/piis1470-2045(12)700700/fulltext; bryant furlow, us physician whistleblowers face intimidation and retaliation, 12 lancet oncology 727 (2011), available at 2013 541 indiana health law review scientist dr. david graham testified as to the retaliation he suffered internally when he questioned whether vioxx increased the rate of heart attacks in patients who took it.143 8. accepting anonymous complaints if the goal of implementing a whistleblower protection system is to improve the public's health by bringing to light safety concerns about new drugs, then it is important to create a system where those with knowledge can come forward without fear of retaliation one of the most effective ways of protecting whistleblowers is to permit anonymous reporting. 144 yet, both the government and private industry have been very reluctant to do so. none of the federal whistleblower programs overseen by the office of special counsel accept anonymous reporting. 145 the office of special counsel, http://www.thelancet.com/journals/lanonc/article/piis1470-2045(11)701802/fulltext.; rich daly, grassley queries fda chief on retabation violations, modernhealthcare.com (feb. 2, 2012, 5:15 pm), http://www.modernhealthcare.com/article/20120202/news/302029962#. 143 withdra wal from the market of vioxx arthritis pain medication. hearing before the s. fin. comm., 108th cong. 2 (2004)(statement of dr. david j. graham, associate director science, office of drug safety, center for drug evaluation and research); see amanda j. dohrman, rethinking and restructuring the fda drug approval process in light of the vioxx recall, 31 j.corp.l. 203, 208 (2005)(recounting graham's statements to the senate and to the press about his experiences of retaliation). 144 james e. hunton and jacob m. rose, effects of anonymous whistle-blowing and perceived reputation threats on investigations of whistle-blowing allegations by audit committee members, 48(1) journal of management studies 75, 76 (summarizing the literature as finding "research of this nature finds that employees are less likely to use non-anonymous channels when anonymous channels are made available, and suggests that anonymity has the capacity to enhance the effectiveness of whistle-blowing reporting because anonymous channels encourage employees to report allegations without fear of reprisal"). 145 anonymous in this context would be to make a report without any other person knowing. in contrast, the sec offers reporting through an attorney: "to anonymously report possible violations of the securities laws to the sec, a whistleblower is required to be represented by an attorney and must provide his or her counsel with a copy of the submission signed 542 vol. 10:2 putting patients first which oversees several of the existing federal whistleblower protection statutes, makes clear that "[w]hile osc will protect the identity of persons who make disclosures, it will not consider anonymous disclosures. if a disclosure is filed by an anonymous source, the disclosure will be referred to the office of inspector general in the appropriate agency. osc will take no further action."146 the office of special counsel's stance is consistent with a growing tide of criticism over whistleblower anonymous reporting systems. the issue is not one of logistics. technology to provide anonymous electronic complaint boxes is easily available and not expensive.147 rather, the reasons given have been substantive. anonymous reporting has come under considerable criticism from those who argue that anonymity encourages reporting by those motivated to harm the company, not necessarily to benefit the public. 148 in contrast, commentators focused on health & safety concerns are less concerned about motives. 149 under the penalty of perjury. the attorney will verify the identity of the whistleblower before any information is submitted to the sec; serve as an intermediary between the sec and whistleblower during any investigation and related enforcement action") http://www.secwhistlebloweradvocate.comlprogram/anonymous-reporting. 146 form osc12, supra note 131. 147 neomailbox, https://neomailbox.net (last visited may 28, 2013). 148 see generally mary ann roser, new law bans anonymous complaints about doctors, statesman (sept. 18, 2011, 8:20 pm), http://www.statesman.com/news/texas-politics/new-law-bans-anonymouscomplaints-about-doctors1865789.html?printarticle-y (noting that texas passed a law forbidding their medical board to consider anonymous complaints); anonymous w12istleblower reporting systems, isight, (apr. 7, 2010), http://i-sight.com/whistleblower/ anonymous-whistleblowerreportingsystems/ ("audit committee members find anonymous allegations to be less credible than non-anonymous allegations. as a result, audit committee members often choose not to investigate an anonymous allegation, even when the allegation indicates very serious threats to the integrity of the financial reporting system. when an identical allegation is not anonymous, audit committees allocate significant resources to the investigation of the allegation. in brief, anonymous allegations appear to be ignored in many cases."). 149 fulcrum, supra note 126. 2013 543 indiana health law review any anonymous reporting system that fills the gap left when the danger to health or safety is not one that can be compensated through the current qui tam bounty system.o50 developing a system that provides incentives to those with information about possible dangers associated with newly approved drugs to come forward should be the primary consideration in order to protect human subjects and those taking new drugs. 51 if the danger is to the life or health of humans involved in a drug trial or taking a prescription drug, then this should outweigh the administrative inconvenience of anonymous complaints. conversely, the epa allows anonymous reporting.152 also, it is not unusual for hospital whistleblower policies to accept anonymous complaints.153 150 tom avril, philadelphia is a hotbed for drug-industry whistleblower lawsuits, philly.com (jan. 18, 2011), http://articles.philly. com/2011-01-18/news/270346921schering-plough-drug-companies-industry (noting that the federal government has recovered billions of dollars in qui tam actions against pharmaceutical companies). 151 cf patrick collins et al., consider the source.' how weak whistleblower protection outside the united states threatens to reduce the impact of the dodd-frank reward among foreign nationals, perkins coie llp, http://www.perkinscoie.com/files/ upload/10_25article.pdf (last visited apr. 23, 2012) (discussing how whistleblowing provisions of the foreign corrupt practices act are not likely to result in more information about bribery because they do not provide adequate protection for the foreign nationals with direct access to information); veenema & t6ke, supra note 138 (noting that monitoring of electronic medical records for incidences of bioterrorism is a well-established warning system in the event of a bioterrorist attack). 152 confidentiality, anonymity, and whistleblower protection, epa.gov, http://www.epa.gov/oig/hotline/protection.htm (last visited apr. 23, 2013) ("if you do not wish to disclose your identity, you may remain anonymous when contacting the oig. however, please keep in mind that anonymity may impede a quick or thorough investigation or the success of a later prosecution."). 153 see catholic health services of long island whistleblower protection policy, good sa1maritan hosp. med. center, http:// goodsamaritan.chsli.org/index.phplwhistle-blower-policy (last visited apr. 23, 2012) (stating that good samaritan health systems of long island whistleblower policy includes, "[r]eports of potential violations may be oral or written and may be delivered .. (c) by anonymous letter to the system affiliate compliance officer or chs compliance officer."). 544 vol. 10:2 putting patients first iv. policy arguments a. normative arguments reviewing the arguments of those objecting to these proposals on normative, as opposed to operational, grounds requires the creating of a taxonomy of protesters which sifts out those with general objections to increased governmental regulations or who are satisfied with the safety standards achieved by existing regulation from those who believe that regulating human subject research and drug safety is an appropriate activity for the federal government and that the current system is not working in a way they find acceptable, but still disagree with strengthening and extending whistleblower protections for those with inside knowledge. any such effort at anticipating and addressing normative objections must start with the existence of a serious problem: adding layers of regulation costs money. i know of no political theory or moral code endorsing the imposition of expensive regulation in the absence of a proportionately serious harm. therefore, the need for expanded regulation is based on the proposition that neither current regulation nor the free market is providing sufficient protection to consumers of prescription drugs from dangers that emerge after fda approval. it is further based on the fact that a large portion of the public in the united states has or will take prescription drugs. therefore, the cost of this regulation satisfies what russell b. korobokin describes in libertarian welfarism the "the requirement of kaldor-hicks efficiency otherwise known as cost-benefit analysis. that is, the beneficiaries of the regulation should gain enough so that they could fully compensate those who are burdened."154 154 see russell b. korobkin, libertarian welfarism, 97 cal. l. rev. 1651, 1671-72 (2009) (citing richard a. posner, economic analysis of law 13 (7th ed.2007) and matthew d. adler, beyond efficiency and procedure: a welfarist theory of regulation, 28 fla. st. l. rev. 241, 244-46 (2000)) (laying out the principles of this theory in the process of developing his own theory of reducing paternalism while still providing a welfare state). 5452013 indiana health law review to effectively provide sufficient protection it is necessary to first identify and set aside general objections that apply to any kind of increased regulation, and then confront those specific to this proposal. the state's general authority to regulate prescription drugs comes from the social contract theory as advanced by john stuart mill, which asserts that when individuals seek the benefit of living together in a society, they give up some of their individual rights. applying this theory to justify a state's right to prohibit access to pornography, chief justice warren burger wrote that "our constitution establishes a broad range of conditions on the exercise of power by the states, but for us to say that our constitution incorporates the proposition that conduct involving consenting adults only is always beyond state regulation, is a step we are unable to take." 5 5 the question then becomes how to identify the least intrusive method of regulation that results in acceptable standards of safety for those involved in drug testing or for consumers. having cleared the conceptual hurdle of federal regulation of medical research, these proposals face the far more specific concerns of those espousing the kind of free market views increasingly ascribed to the late president ronald reagan. these critics may accept the need for some regulation and may even be dissatisfied with current levels of safety, but still believe that this is the kind of problem best left to the marketplace. while the objections listed above reflect the reasoned views, i suggest to them that their philosophical objections to government regulation and the value they put on an orderly work-place do not outweigh the greater claim of measures to reduce unnecessary deaths in the process of developing and marketing the very products which are supposed to improve health. whatever interests are balanced on the side of less regulation are weak in comparison to the extent of the harm. because of the enormous amount of money involved, drug research is a paradigm of an activity where serious inequality of 155 paris adult theater i v. slaton, 413 u.s. 49, 68 (1973). 546 vol. 10:2 putting patients first resources makes it impossible for any single consumer to exercise the kind of power needed to force improved safety. 1. positivist arguments the proposals made in this article are vulnerable to all the general arguments against increased governmental regulation as well as ones specific to medical research. 156 these can be summarized as objections based on cost, constitutionality, efficacy 15 7, as well as normative concerns about the desirability of increased whistleblower protection. the discussion below goes beyond the general concerns that could be raised about any new regulatory proposal; but further considers requiring that applicants for permission to market new drugs certify that they have provided accessible and effective methods for anyone with information about a possible danger to the public's health to bring these concerns to the fda's attention. 2. cost-benefit analysis while it is beyond the scope of this article to engage directly in a cost-benefit analysis of a law to increase the protection of pharmaceutical company employees in order to encourage them to bring forward information about potential dangers from drugs and devices, it is important to review what such an analysis would involve and who would 156 for a discussion of the intrinsic difficulties of changing the law without considering information from other disciplines about its likely effect on human behavior see peer zumbansen, rethinking the nature of the firm: the corporation as a governance object, 35 seattle u. l. rev. 1469, 1479-80 (2012) ("we must remain aware of the continuously mounted challenges of law's empire, as they are promulgated by economists, sociologists, geographers, or anthropologists, just to name a few of the disciplines with a keen interest in law as a governance tool."). 157 kristin e. hickman & claire a. hill, concepts, categories, and compliance in the regulatory state, 94 minn. l. rev. 1151, 1154 (2010) (arguing that it is difficult to predict whether or not a new regulation will result in the desired effect because "[rlegulated parties then adjust their behavior, but again not necessarily in ways that regulators expect or want."). 2013 547 indiana health law review conduct it. all proposals to change the law must address the issue of the cost of change in relation to the benefit achieved. 158 congress sends proposed laws to federal agencies and to the congressional budget office (cbo) which "provides formal written estimates of the cost of virtually every bill 'reported' (approved) by congressional committees to show how it would affect spending or revenues over the next 5 or 10 years, depending on the type of spending involved."159 this law would fall under the category of a "life-saving" regulation. 160 a cost-benefit analysis, then, requires the balancing of human lives saved that can be attributed to a drug versus lives lost. second, there are two different sources of cost. the first issue is the cost of administering and enforcing a new whistleblower protection program. whether this is done by an existing federal agency, a new federal agency, or contracted to a private organization, the cost of running this program should be shouldered by those who stand to profit from the drugs developed. developing pharmaceutical products for sale on the u.s. market is such a profitable activity that a whistleblower monitoring and protection program could be funded by the pharmaceutical companies themselves as part of the cost of getting fda approval.161 also, pharmaceutical companies already pay the fda 158 richard 0. zerbe, the legal foundation of cost-benefit analysis, 2 charleston l. rev. 93, 100 (2007) (noting that congress uses cost benefit analysis to "allay conflict" between competing interest groups and "reach agreement"). 159 about, cong. budget office, http://www.cbo.gov/about/ourwork (last visited apr. 27, 2013). 160 for an extensive analysis of the role of cost-benefit analysis in life-saving regulations, see generally john d. graham, saving lives through administrative law and economics, 157 u. pa. l. rev. 395 (2008). 161 donald l. barlett & james b. steele, wy drugs cost so much, time (feb. 2, 2004), available at http://www.time.com/time/magazine/ article/0,9171,993223-2,00.html ("[tihe pharmaceutical industry is--and has been for years--the most profitable of all businesses in the u.s. in the annual fortune 500 survey, the pharmaceutical industry topped the list of the most profitable industries, with a return of 17% on revenue."). 548 vol. 10:2 putting patients first directly to fund extra staff in order to provide expedited review of their applications and can well absorb the costs of a whistleblower program.162 the second issue involving cost is that any cost to the pharmaceutical companies will be passed on to the consumer in the form of higher drug prices. this is a serious concern and an unfortunate consequence of the u.s.'s decision not to control the price of pharmaceuticals or even, in the case of medicare, to bargain for lower costs. however, a 2010 study commissioned by the new england journal of medicine concludes that whistleblowers at pharmaceutical companies are not motivated by money, but rather a genuine interest in the public's welfare and the success of the company.163 if true, it is likely that greater protection will encourage whistleblowers and it will not be necessary to provide substantially increased amounts of money. finally, many of these new federal programs providing financial incentives have come under attack by the business community for interfering with internal compliance operations. 164 the argument goes that if employees have federal monetary incentives to "blow the whistle" they will by-pass existing quality assurance programs operated by the companies themselves. recent research has disproved this concern.165 162 prescription drug user fee act (pdufa), 21 usca § 379(h) (2000); see also prescription drug user fee act (pdufa), fda.gov (dec. 12, 2012), http://www.fda.gov/forindustry/userfees/prescription druguserfee/default.htm. 163 aaron s. kesselheim et al., whistle-blowers' experiences in fraud litigation against pharmaceutical companies, 362 new eng. j. med.,1832, 1834 (2010) ("every relator we interviewed stated that the financial bounty offered under the federal statute had not motivated their participation in the qui tam lawsuit. reported motivations coalesced around four non-mutually exclusive themes: integrity, altruism or public safety, justice, and self-preservation."). 164 richard e. moberly, unfulfilled expectations: an empirical analysis of why sarbanes-oxley whistleblowers rarely win, 49 wm. & mary l. rev. 65, 76-78 (2007). 165 nat'l whistleblower ass'n, impact of qui tam laws on internal compliance: a report to the securities and exchange commission (2010), http://www.whistleblowers.org/index.php?option= com content&task=view&id=1169. in response to a request for comments from the securities and exchange commission on proposed rules 2013 549 indiana health law review 3. criticisms based on efficacy just as drugs must be both safe and effective, any system to improve post-market safety must also demonstrate efficacy. in other words, if granted this power can the fda make use of them to effectively to protect the public's health? professor peter schuck has described this question as "the 800-pound gorilla in the room" in that "many critics denounce the agency's enforcement activity as lax and inadequate" with "some go[ing] so far as to claim that the regulated industries have "captured [the fda]" thus making it impossible for it to regulate effectively. 166 facts support this suspicion. a recent analysis of industry influence over congress found pharmaceutical companies first on the list.16 7 pharmaceutical companies spent over $250 million lobbying congress in 2009 americans for campaign reform reports that in 2008 these contributions were distributed widely with each "member of the house . . . received an implementing the whistleblower provisions of section 21f of the securities and exchange act of 1934, the national whistleblowers association, not of course an impartial source, submitted a report based on a study considering its likely "impact on corporate compliance programs." id. its conclusion was that, "the objective data demonstrates that whistleblower reward laws have no impact whatsoever on the viability of internal corporate compliance programs or the willingness of employees to report suspected violations to their employers. the concerns raised by numerous corporate commentators are not in any way supported by the actual underlying data." id. (emphasis in original). 166 peter schuck, fda preemption of state tort law in drug regulation: finding the sweet sport, 13 roger williams law review 73, 112 (2008). 167 jay p. kesan & andres a. gallo, political economy of the patent system, 87 n.c. l. rev. 1341, 1364-1365 (2009) (the authors explained that their project was to rank "[d]ifferent sectors according to their influence on congress. this ranking helped us analyze the direction of the proposed changes and the relative strength of each sector over congress." the authors further explain that the ranking accurately reflects influence because it is not just based on dollars spent because "the aggregate amount of money given cannot be the sole determinant of power in congress. rather, rates of giving, the number of companies involved in the activities, and recent increases in lobbying efforts can affect the ranking. we therefore gave each sector a score from one (strong power in congress) to five (weak power)."). 550 vol. 10:2 putting patients first average of $25,277" from the pharmaceutical industry and each individual member of the senate "received an average of . .. $81,891."168 in my opinion, the success of any measure which seeks to improve post-market safety by increasing the amount of information coming to the fda must meet two criteria before it can be deemed successful. first, the actual amount of information about dangers to the public's health has to increase and second, the fda has to make use of the information. there is no guarantee that simply providing information will increase safety. indeed, a study at johns hopkins found that 96% of warnings issued by a hospitals' internal prescription monitoring software were ignored. 16 9 these sums are not surprising given the profitability of the industry and the fact that these profits depend directly on the decisions congress makes in the area of patents, consumer protection, health and safety. it is reasonable to assume that any legislation that erodes their profits will be met with full force opposition of the pharmaceutical industry through their lobbyists. however, seeking reforms will educate consumers about the dangers they face and lay a foundation for future reform efforts. stricter laws protecting whistleblowers in the united states might also backfire by encouraging the already prevalent practice of exporting medical research overseas. it is therefore important that any proposed legislation close this loophole by requiring the fda to monitor companies seeking to market drugs, vaccines or medical devices in the united states to make sure they have a documented program for protecting scientists conducting basic research. v. constitutionality these proposals for expanding the fda's ability to protect patients after a drug has been approved and is on 168 americans for campaign reform, money in politics & prescription drugs, http://www.acrreform.org/researchlmoney-in-politicsprescription-drugs/ (last visited august 17, 2013). 169 clinicians ignore most drug alerts from cpoe systems, study finds, ihealthbeath (apr. 9, 2012), http://www.ihealthbeat.org/ articles/20 12/4/9/clinicians-ignore-most-drug-alerts-from-cpoesystemsstudy-finds.aspx?topic=patientsafety. 2013 551 indiana health law review the market encompasses activity by a federal agency which crosses state lines and therefore it is important to consider the constitutional basis for its ability to engage in this activity. since the first cases challenging the pure food and drug act of 1906 (pfda), which is the precursor of today's laws granting regulatory authority to the fda, the supreme court has consistently upheld congress' authority to preempt state regulation of food and drug safety.170 a. federalism the classic argument opposing all efforts to extend federal regulation is essentially one based on the concept of federalism which means that states, rather than the federal government, are in the best position to protect the health and safety of their citizens.171 as dean erwin chemerinsky explains, "throughout american history, and especially in the 1990s, federalism has been used by conservatives as a way of trying to limit government power. in other words, conservatives have used federalism as a procedural way of blocking substantive reforms with which they disagree."172 ours is a nation where the federal, or central, government has limited powers and cannot impose its will on the states.173 congress has the authority to act under limited 170 see generally, schacter supra note 43 at 15-20 (recounting history of how the fda came to regulate human drugs); see also howard l. dorfman, vivian m. quyinn & elizabeth a. brophy, presumption of innocence: fda's authority to regulate the specifics of prescription drug labeling and the preemption debate 61 food & drug law journal 585 (2006)(history of supreme court upholding congress' authority to regulate food and drugs). 171 see generally erwin chemerinsky, reconceptualizing federalism, 50 n.y.l. sch. l. rev. 729, 735, 754 (strongly rejecting interpreting the constitution in a way that blocks government action, stating that "[c]onstitutional doctrines about federalism should focus on how to empower each level of government with the necessary authority to deal with the complex problems of the 21st century."). 172 id. at 735. 173 see buckley v. valeo, 424 u.s. 1, 122 (1976) (explaining that the "framers regarded the checks and balances that they had built into the tripartite federal government as a self-executing safeguard against the encroachment or aggrandizement of one branch at the expense of the 552 vol. 10:2 putting patinnts first circumstances. first, congress may act if it is directly authorized by the constitution. if not, congress may only act if the supreme court has recognized the proposed exercise of power, or one very like it, as a permissible exercise of federal power. because there is nothing in the constitution about protecting the public's health, the supreme court found that the police powers of the states, not the federal government, may embrace legislation designed to promote the public's health and welfare. 174 therefore, we must look to the more general provisions regarding what congress can do in the face of objections by one or more states. the most likely source of congressional power to regulate prescription drugs is found in the power the constitution gives congress in article i, section 8 to regulate commerce. 75 in other words, congress has the authority to protect against the dangers of prescription drugs by requiring compliance with regulations intended to provide that protection. congress' power under the constitution to regulate the pharmaceutical companies is even more direct than its spending power because the entire pharmaceutical industry depends on having exclusive access to particular drugs through the patent system over which congress has direct authority.17 6 congress' first power is to award patents, a power enumerated in the constitution. 7 7 other"). 174 chicago b. & 0. railway co. v illinois, 200 us 561, 592 (1906) ("the police power of a state embraces regulations designed to promote the public convenience or the general prosperity, as well as regulations designed to promote the public health, the public morals or the public safety."). 175 u.s. const. art i, § 8, cl. 1. see e.g., lawrence m. friedman, a history of american law 329-349 (2005). congress might, but usually does not, also invoke its power to spend money to promote health and welfare. coll. say. bank v. fla. prepaid postsecondary educ. expense bd., 527 u.s. 666, 686 (1999) ("congress may, in the exercise of its spending power, condition its grant of funds to the states upon their taking certain actions that congress could not require them to take, and that acceptance of the funds entails an agreement to the actions."). 176 see u.s. const. art. i, § 8 (8) (giving congress the power "[tlo 5532013 indiana health law review given congress' power to establish the fda and grant it power to regulate prescription drugs, what limits the fda's ability to implement rules and regulations is the extent to which it is acting within the scope of this power. b. conflict with existing state laws: pre-emption since regulation of prescription drugs and devices is subject to federal, not state, regulation the fda's adoption of further protections against post-approval harm cannot run afoul of any state law. states have no say in how the fda oversees drug safety. however, a series of decisions by the supreme court interpret the availability of a private right of action based in state law should a patient be harmed by either a device or drug after fda approval.178 in riegel v. medtronic, the court held that in granting the fda exclusive jurisdiction over medical devices, congress intended to deprive plaintiffs of state tort remedies caused by a defective product.179 therefore, a patient who claims promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries"); see generally, michael w. carroll, one size does not fit all: a framework for tailoring intellectual property rights, 70 ohio st. l.j. 1361, 1367-1370 (2009) (discussing the powers granted congress by the constitution which allow it to make industries more or less profitable depending on congress' own decisions about the public's best interests). 177 see megan l. wiggins, patent reform and damages apportionment: addressing the concerns of industry-scale users of the us. patent system without legislatively mandating a "specific contribution over the prior art" 40 seton hall l. rev. 273, 280-283 (2010) (providing an overview of the u.s. patent system with an emphasis on it affects the pharmaceutical industry). 178 see generally, demetria d. frank-jackson, the medical device federal preemption trilogy: salvaging due process for injured patients, 35 s. ill. u. l.j. 453 (2011) 179 riegal v. medtronic, 552 u.s. 312, 316 (2008) (citing 21 u.s.c. sec 360k(a)(2006("except as provided in subsection (b) of this section, no state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a 554 vol. 10:2 putting patients first injury from a device could not bring an action in state court. the court in wyeth v. levine, however, found a lack of a specific preemption of state action in the fdca, which gives the fda authority to regulate prescription drugs. 180 it reached the conclusion that in granting the fda authority to regulate prescription drugs, but not explicitly precluding a state law remedy congress did not intend to limit the remedy of patients harmed by them. 181 in the absence of congress explicitly adding medtronic type preclusion language, patients who are harmed by prescription drugs can pursue a private right of action. in extending whistleblower protection to pharmaceutical company employees, then, congress could resolve this conflict by making clear that it intends to include information about all products developed, manufactured or requirement applicable to the device under this chapter."). 180 wyeth v. levine, 555 u.s. 555 (2009). see also allison kostecka, wyeth v levine: examining the doctrine of implied preemption in state-law tort claims, 4 duke j. const. l. & pub. pol'y sidebar 227 (2009). 181 wyeth, 555 u.s. at 578 ("powers of the states were not to be superseded by the federal act unless that was the clear and manifest purpose of congress."); see also victor e. schwartz et al., marketing pharmaceutical products in the 21st century, 32 harv. j.l. & pub. pol'y 333, 385 ("as the scale and complexity of pharmaceutical production reaches new heights, the need for comprehensive federal regulation becomes increasingly imperative. greater recognition of federal preemption helps to achieve the objectives of such regulation by assuring definitive and uniform application. further, preemption serves public policy goals of predictability and fundamental fairness by informing pharmaceutical participants of their complete set of legal obligations rather than simply setting a floor and forcing manufacturers to abide by fifty different state law interpretations.") (citing buckman co. v. plaintiffs' legal comm., 531 u.s. 341, 350 (2001) ("as a practical matter, complying with the fda's detailed regulatory regime in the shadow of 50 states' tort regimes will dramatically increase the burdens facing potential applicants-burdens not contemplated by congress in enacting the fdca . . . .")). moreover, should the federal regulation not pre-empt state law, it could serve as a standard of care for negligence. see roger l. jansson, researcher liability for negligence in human subject research: informed consent and researcher malpractice actions, 78 wash. l. rev. 229, 245-246 (2003) (arguing that a federal law establishing a duty of care by a researcher to a human subject would provide subjects with basis to bring negligence suits if harmed). 2013 555 indiana health law review sold by a pharmaceutical company that are already regulated by the fda. 182 because a new statute would expressly pre-empt state law, the supreme court's only review would be whether or not the pre-emption falls within congress power, not, whether pre-emption is implied. vi. conclusion it is inevitable that information about the safety and efficacy of prescription drugs approved for sale to the public by the fda will emerge once larger numbers of patients start taking the drugs outside the controlled setting of a clinical trial. the short time in which most prescription drugs are tested before they go on the market effectively transforms those patients prescribed drugs newly approved by the fda into research subjects. yet unlike research subjects who are protected by laws which monitor their safety, there are no special legal protections for patients taking newly approved drugs. this article has considered the concerns of regulators, the medical community, patient advocates and academics and proposes several additional ways to increase safety by increasing the amount of information available to the fda. this article proposes shifting the burden of identifying post-market problems to drug sponsors. it also proposes steps to increase the flow of information from the health care community and patients themselves. sponsors must take on more responsibility for gathering information and bringing it to the fda. this includes providing explicit protections for their employees and contractors with inside information, whistleblowers, to bring their knowledge directly to the fda. it also proposes that healthcare providers take on affirmative obligations to report adverse events from new drugs. although this may seem burdensome, in fact most prescribing physicians receive weekly visits from drug sponsors and can easily meet their obligations by reporting the information, which in turn the sponsor would then be 182 see kostecka, supra note 180. 556 vol. 10:2 putting patients first required to report to the fda. this reporting requirement should include any decision to stop prescribing a drug either because it was not effective or because of an emerging side effect. for patients, this article suggests that they be explicitly informed both that they are taking a newly approved drug and that they either be required or at least strongly urged to agree to increased surveillance of their interactions with the health care system, including purchases of nonprescription drugs. while simply advising patients to be aware of the likelihood that information about the drug they are taking will emerge after it is prescribed can increase awareness, it may not be possible for any individual to appreciate that ostensibly unrelated symptoms, such as leg cramps, might be an emerging, and perhaps dangerous, side effect of the new drug. finally, it proposes creating an official period of postmarket surveillance for all newly approved products, not just ones which the fda determines may pose particular risks.183 without structural change that shifts the burden of drug safety onto the sponsors, we cannot have a system of regulation that puts patients first. 183 margaret z. johns, informed consent: requiring doctors to disclose off-label prescriptions and conflicts of interest, 58 hastings l.j. 967, 989 (2007). 5572013 notes slaying the hydra: the history of quack medicine, the obesity epidemic and the fda's battle to regulate dietary supplements marketed as weight loss aids katharine a. van tassel• i. introduction .••••••....•........•......•.................•.•......•....••••...•.....•..••.. 204 ll. the obesity epidemic and tile status of being overweight as a significant, independent risk factor for chronic disease ......•.•.•..••...•..•.•......•.....•.•....••.•..••.....•••.....•••..•.•••.....••....••.•. 208 a. being overweight as a significant risk factor for type ii diabetes, cardiovascular disease and cancer ....................... 209 i. type ii diabetes ................................................................. 209 2. pre-diabetes ...................................................................... 211 3. cardiovascular disease ..................................................... 211 4. cancer ............................................................................... 212 ill. the growth of tile weight loss supplement industry ..•.•• 213 iv. a history of fda regulation of deceptive and unsafe products: the transmon from post-market policing to pre-market prevention···························································· 215 a. the rise of the quack remedy ................................................. 218 b. the pure food and drug act of i906: a victory for predatory commercial interests ............................................................... 220 i. sham weight loss supplements under the i906 act ........ 222 a. marmo /a i ................................................................... 222 c. the food, drug and cosmetic act of i938: the public health costs of the post-mi:zrket policing of deceptive and unsafe products ................................................................................... 223 i. safety and efficacy under the fdca of i938 .................... 224 2. misrepresentations under the fdca of i938 .................... 225 3. sham weight loss supplements under the fdca of 1938 ............................................................................... 226 a. marmola ii .................................................................. 227 * professor oflaw, western new england college school oflaw. b.sn., case west­ ern reserve university; j.d., case western reserve university school oflaw; m.p.h., harvard school ofpublic health. this article was prepared while visiting as a professor oflaw at the university of pittsburgh school of law. author contact information: western new england college school oflaw, 1215 wilbraham rd., springfield, ma 01108. phone: 413-782-1428. email: kvantassel@law.wnec.edu. i would like to thank professor anne schiff of the university ofpittsburgh school oflaw and dean jim chen of the university oflouisville, louis d. bran­ deis school of law for their thoughtful comments on this article. 204 indiana health law review [vol. 6:203 d. safety and effectiveness and the kefauver-harris amendments of 1962: the public health benefits of pre-market prevention . 228 e. the modern fda regulatory structure and the fda's gatekeeper role ...................................................... · ................. 229 v. a history of the dietary supplement health education act: the public health costs of returning the fda to post-market policing of deceptive and unsafe products ....................................................................................... 231 a. the supplement industry wins the battle over the regulation of vitamins ................................................................................... 232 b. the relationship between the arrival of functional foods and the dietary supplement health education act... ...................... 235 1. the national labeling and education act (nlea) ........... 236 2. the dietary supplement health education act (dshea). 239 vi. the impact of the dietary supplement health education act on the overweight and their risk for type ll diabetes, cardiovascular disease and cancer .................................... 241 a. opening the door to predatory commercial practices: dshea and the case of ephedra .......................................................... 241 vll. proposals for triggering the fda's premarket approval process to eliminate sham weight loss supplements ....... 243 a. weight loss supplements and "structure and function claims'' .................................................................................... 244 1. the limitations of dshea 's safe harbor ......................... 245 b. the limitations ofnlea 's safe harbor .................................. 247 c. weight loss supplements and "disease claims" .................... 248 1. reduction of risk factor claims ....................................... 248 vlll. conclusion .................................................................................. 250 i. introduction the united states' obesity crisis is gaining momentum. studies released in 2008 project that, in only fifteen years, eighty percent1 of americans will be either overweight or obese. 2 being overweight or obese places an individual at 1. youfa wang et al., will all americans become overweight or obese? estimating the progression and cost of the us obesity epidemic, 16 obesity 2323, 2323 (2008), http://www.nature.com/oby/journallv16/nl0/full/oby2008351a.html. approximately 91 %of mexican-american men and 96% of non-hispanic black women will be affected by 2030. by 2034, all black women will be either overweight or obese and by 2048, all american adults will have reached this condition. /d. 2. according to current standards, adults are overweight if their body mass index ("bmi") is between 25 and 29.9 and are obese if their bmi is 30 or greater. study suggests 56 percent of americans could be overweight by 2030, scmnce daily, july 29, 2008, http://www.sciencedaily.com/releases/2008/07/080728192936.htm. 2009] slaying the hydra 205 significant risk of developing hypertension, type ll diabetes, heart disease, stroke and cancer. 3 if this epidemic goes unchecked, conservative estimates predict that the health care costs associated with this crisis will reach $956.9 billion in the 2020s, with one in every six dollars spent on health care related to the conditions of being overweight and obese. 4 moreover, for the first time in over a century, children and young adults will have a shorter life expectancy than their parents. 5 the obesity epidemic has triggered a correspondingly massive growth in the weight loss supplement6 industry. overweight consumers desperate to lose weight are being lured by 'magic bullet' claims into purchasing 'quick-fix' weight loss supplements in order to lose weight and decrease their risk for dis­ ease. 7 many of these consumers, and their physicians, incorrectly believe that the food & drug administration ("fda") requires premarket testing to estab­ lish the validity of these claims. 8 taking advantage of consumers' vulnerability and misperceptions regarding fda oversight, the sale of weight loss supple­ ments in the united states reached $4.7 billion in 2001,9 with projected in­ creases of ten to twenty percent annually.10 weight loss supplements are the fastest growing segment of the dietary supplement industry.11 however, the majority of these products are ineffective.12 the federal trade commission ("ftc") reports that more consumers are defrauded by weight loss products than any other product it has examined. 13 like hercules and his attempts to slay the many-headed hydra, for every weight loss supple3. treating obesity vital for public health, physicians say, science daily, dec. 5, 2006, http://www.sciencedaily.comlreleases/2006/12/06120 1180423.htm. 4. id. 5. s. j. olshansky et al., a potential decline in life expectancy in the united states in the 21st century, 352 new eng. j. med. 1138, 1138-45 (2005). 6. when this article refers to weight loss supplements, it is adopting the same definition as the general accounting office by "referring to individual ingredients, not specific products or brands, some of which might contain multiple ingredients. weight loss supplements include herbal or other botanical ingredient such as aloe, ephedra, fiber, and green tea; minerals such as chromium and pyruvate; as well as amino acids, enzymes. and tissues from organs or glands." dietaryweighflosssupplements:lm.fed.oversighrhasfocusedmoreonmarketing than safety: before the subcomm. onovi!rsighrofgov. mgmt., restruciur.ing,andthe dist. of columbia. comm. on gov. affairs, u.s. senate, 1 (july 31, 2002) {statement of janet heinrich, director, public health issues, u.s. general accounting office), www.gao.gov/new.items/d02985t.pdf[hereinafter statement ofdirector heinrich, gao]. 7. see infra notes 54-71 and accompanying text. 8. see infra notes 65-66 and accompanying text. 9. consumer heallhcare prod. assoc., http://www.chp a-info.org {last visited on may i 0, 2009). 10. statement of director heinrich, gao, supra note 6, at 1 n.1. 11. /d. 12. see infra notes 67-71 and accompanying text. 13. fed. trade comm'n., consumer fraud in the united states: the second ftc survey 15 (oct. 2007), http://www.ftc.gov/opa/2007/10/fraud.pd.t: see also fed. trade comm'n., weighf loss advertising: an analysis of culumnt trends 30 (sept. 2002), http:f/www.ftc.gov/bcp/reports/weightloss.pdf(55% of claims made by over-the-counter weight loss products were false or misleading). 206 indiana realm law revjew [vol. 6:203 ment that the ftc successfully removes from the market, it appears that dozens more are spawned.14 thus, u.s. consumers are being thwarted in their weight loss and disease reduction efforts and the obesity crisis continues to mushroom. why isn't the fda using its premarket approval authority to keep these sham products from entering the market in the first place? not surprisingly, the weight loss supplement industry is marketing its products as dietary supple­ ments and is claiming the safe haven protections from fda regulation offered under the dietary supplement health education act ("dshen')15 and the na­ tional labeling education act of 1990 ("nlea'').16 what is surprising is that the fda appears to agree.17 are the weight loss supplement industry and the fda correct? in order to answer this question, this article reviews the history of the regulation of quack medicines under the food, drug and cosmetic act ("fdca") and outlines the events and legislative history that preceded the pas­ sage ofdshea and nlea. in conducting this inquiry, this article examines the historical relationship between the state of scientific uncertainty over the effectiveness and safety of new products intended to treat abnormal health con­ ditions and predatory commercial practices. a look at this historical relationship informs the debate over the proper regulatory balance between the protection of individual choice in matters in­ volving self-regarding behavior, such as making food choices, and the need to protect vulnerable consumers from bann from third parties who are marketing health care products, including weight loss supplements. the proper balance between these interests is achieved by linking the level of product regulation with the health status of the product's targeted population. historically, the greatest amount of regulatory protection has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individu­ al's struggle to return to normal health. examples of products that fall into this category include drugs and devices. conversely, the fdca requires less regu­ latory protection when products are targeted to healthy populations to maintain 14. sheila f. anthony, comm'r, fed. trade comm'n. combating deception in dietary supplement advertising, remarks at the food and drug law institute 45th annual educational conference (apr. 16, 2002), http://www.ftc.gov/speeches/anthony/dssp2.shtm. in its role of preventing unfair or deceptive practices in the market place, the ftc oversees dietary supple­ ment advertising in an attempt to ensure that product claims are both truthful and substantiated. statement ofdirector heinrich, gao, supra note 6, at 1 n.1. weight loss supplement manufac­ tures claim that their products work by reducing appetite or cravings, increasing metabolic rate, having a laxative effect, and blocking the digestion of carbohydrates, fat, and sugar. id com­ plicating the picture, manufacturers often combine multiple ingredients into the same product and claim several different mechanisms through which their products work to achieve weight loss. id. the ftc can insist false, exaggerated, or unsubstantiated claims be removed ftom product advertising. the ftc can also seek monetary relief for conduct that causes damages to consumers. id 15. see infra notes 216-257 and accompanying text. 16. id 17. id 2009] slaying tile hydra 207 or improve a normal state of health. examples of products that fall into this category are traditional foods, a very limited number of functional foods under nlea and a similarly narrow category of dietary supplements as defined by dshea. moreover, the history of quack medicines teaches that the need for this di­ chotomy that protects unhealthy, vulnerable populations is strongest when there is a high degree of scientific uncertainty18 over the effectiveness and safety of products intended to treat abnormal health conditions. time and events estab­ lish that there is a direct relationship between scientific uncertainty and high levels of predatory profiteering. currently, there is a high level of scientific uncertainty over the safety and effectiveness of the vast majority of supple­ ments, including those marketed for weight loss. 19 this article is arranged as follows. after this introduction, part ii docu­ ments the public health crisis facing this country from the epidemic of over­ weight and obese individuals who are at serious risk for type ii diabetes, cardiovascular disease and cancer. part ill discusses the remarkable growth of the weight loss supplement industry that tracks the expanding obesity epidemic and points out that this market exists even though a large portion of these prod­ ucts are either ineffective or unsafe. part iv chronicles the 100 year history of the fda's regulation of quack medicines and explains how the fda's historic transition from post-market policing to premarket prevention protects public health from predatory commercial interests, especially when there is scientific uncertainty over safety and effectiveness. part v unravels the history behind nlea and dshea and explains why these acts were intended by congress to deregulate products only to the extent that they target healthy populations to maintain or improve a normal state ofhealth. further, this section explains why interpreting the safe harbor provisions of these acts to include products that target vulnerable, unhealthy populations is detrimental to public health. part vi demonstrates how history has repeated itself with an unintended regulatory rollback that opens the door to modern day snake oil salesmen who are contri­ buting to the obesity crisis. part vii outlines how the fda can assert its pre18. the level of scientific uncertainty over health risks should also play an important role in the fda's decisions regarding the level of regulation of new technologies (like genetically modified food) that are marketed for direct human consumption. see katharine a. van tassel, genetically modified plants for food, risk assessment and uncertainty principles: does the transition from ignorance to indeterminacy trigger the need for post-market surveil­ lance?, 15 b. u. j. sci. & tech. l. 220 (2009). using genetically modified food and the newly discovered characteristics of the networked gene as a case study, this article discusses the pub­ lic health, regulatory, legal and ethical issues that are raised as the science over the public safety of a new technology moves through its natural phases ftom ignorance, to indeterminacy and finally to the point when classical probability analysis can be applied. see also katharine a. van tassel and rose goldman, manufacturing the wings of icarus: fda regulation ofnano­ technology used in products for direct and indirect human consumption (work in progress), www.katharinevantassel.com/selectedpublications.html. 19. see infra notes 292-297 and accompanying text 208 indiana health law review [vol. 6:203 market approval process to prevent sham weight loss supplements from ing the market. ii. the obesity epidemic and the status of being overweight as a significant, independent risk factor for chronic disease under the fdca, products that target vulnerable, unhealthy populations by claiming to either treat disease ("disease claims") or by claiming to alter the structure and function of the body ("structure and function claims") must un­ dergo clinical testing to establish their safety and effectiveness for their in­ tended use?0 products that make these types of claims are considered to be either drugs or devices. 21 if a product is a drug or device it must obtain pre­ market approval from the fda prior to distribution. 22 taking a look at the disease claims category first, the fda has recognized that obesity is a disease. 23 therefore, all products that are intended to treat ob­ esity are either drugs or devices and must undergo clinical testing to establish safety and effectiveness prior to distribution.24 unfortunately, based on the state of the science in 2000, the fda concluded that being overweight (a sepa­ rate weight category from being obese) did not mean that an individual was suffering from a disease.25 because the fda opined that being overweight is not a disease, the current fda position is that weight loss supplements are not making "disease claims." consequently, according to the fda, a manufactur­ er's claims that its product will treat an individual's overweight status does not trigger the obligation to obtain premarket approval for that product from the fda.26 since 2000, the scientific understanding of the relationship between being overweight and the risks of serious, chronic diseases has changed dramatically. in the past decade, a series of studies have been performed that conclusively demonstrate that being overweight is a significant and independent risk factor 20. see infra notes 169-179 and accompanying text. 21. /d. 22. /d. 23. fda final rule: regulations on statements made for dietary supplements concern­ ing the effect of the product on the structure and function of the body, 65 fed. reg. 1000, 1027 (jan. 6, 2000) (hereinafter fda final rule on structure and function claims). the defi­ nition of disease is the "state ofhealth leading to the dysfunction of an organ, part, structure, or system of the body." 21 c.f.r. § l01.93(gxl) (2005). 24. fda final rule on structure and function claims, supra note 23, at l 027. 25. /d. 26. /d. in order to establish that a drug is safe and effective, a manufucturer must produce "substantial evidence." u.s. v. 50 boxesmoreotless. 909 f.2d24, 27 (1stcir. 1990). 'sub­ stantial evidence' consists of"adequate and well-controlled investigations, including clinical investigations, by experts ... which 'adequate and well-controlled investigations' must satisfy a host oftechnical scientific requirements including 'a valid comparison with a control' such as an 'active treatment trial' that includes 'randomization and blinding of patients or investigators' (double blind studies)." /d. at 26 (internal citation omitted). 2009] slaying the hydra 209 for developing serious chronic diseases including type ii diabetes, 27 cardiovas­ cular disease28 and certain types of cancer. 29 in addition. those who are over­ weight are likely to progress to obesity over time.3° consequently, as introduced in the next paragraphs and fully set forth in section vii, c, products that claim to treat the status ofbeing overweight are making disease claims that trigger premarket approval obligations. in addition to falling into the disease claim category, weight loss supple­ ments also make structure and function claims placing them in the second cate­ gory of products that merit drug status. as discussed in section iv, a look at the history of quack medicine, together with the legislative history behind the passage of the fdca, demonstrates that congress was specifically targeting sham weight loss products when it added the structure and function claims cat­ egory. sections v, vi and vii evaluate the history and goals ofdshea and nlea. these sections will explain why neither of these statutory amendments to the fdca changes the regulatory status of weight loss supplements. thus contrary to the current fda position. this article asserts that weight loss sup­ plements must obtain premarket approval from the fda a. being overweight as a significant risk factor for type ii diabetes, cardiovascular disease and cancer being overweight is a serious and independent risk factor for numerous chronic health conditions. significant life style changes, including diet modifi­ cation and exercise habits, can mitigate these risks and short circuit this pro­ gression. but making these changes can be arduous. sham weight loss supplement manufacturers take advantage of this situation by falsely claiming that their products provide an easy way to lose weight that allows consumers to continue unhealthy lifestyles, leading many down a path of no return. i. type ii diabetes in 2007, according to the cdc, 23.6 million people or 7.8 percent of the population of the united states have diabetes.31 devastating complications of 27. see infra notes 31-46 and accompanying text. 28. see infra notes 4 7-50 and accompanying text. 29. see infra note 51 and accompanying text. 30. unfortunately, it is common to progress :from being overweight to the heartbreak of obesity. young adults in their early twenties who are mildly to moderately overweight are sig­ nificantly more likely to be obese by the time they reach their mid to late thirties. k.m. mcti­ gue et al., the natural history of the development of obesity in a cohort of young u.s. adults between 1981 and 1998, 136 annals internal med. 857, 857-64 (2002) (a study that fol­ lowed 9000 young adults for approximately twenty years). and, as pointed out earlier, children born to overweight mothers are more likely to be overweight, and, ultimately, obese. 31. cirs.fordiseasecontrolandplmvennon,dep'tofheai.mandhumanservs., national diabetes fact sheet: general information and national estimates on diabetesintheunitedstates4(2007),http://www.cdc.gov/diabetes/pubs/pdf7ndfs_2007.pdf 210 indiana heallh law review [vol. 6:203 diabetes include blindness, kidney failure and limb amputation. 32 those with diabetes have a risk of death "about twice that of people without diabetes of similar age."33 there is a direct correlation between being obese or overweight and diabetes.34 over ninety percent of those who have diabetes ll are over­ weight or obese. 35 scientists are predicting that the well-publicized childhood obesity epidemic will lead to a corresponding epidemic of type ll diabetes among young adults. 36 a vicious cycle is being created as the children of young women with type ll diabetes have a higher risk for obesity and type ll diabetes~ 37 the longer that one lives with diabetes, the greater the chance of develop­ ing life threatening and disfiguring consequences. 38 unless overweight and obese children lose weight, they are likely to have higher rates of diabetes com­ plications and heart disease than older generations with type n diabetes, which will ultimately decrease their life expectancy. 39 (hereinafter fact sheet]. 32. /d. at 10-11. the risk for developing o1her diseases is increased when an individual is overweight, including the risk of osteoarthritis, respiratory problems (including sleep apnea), gall bladder disease, psoriasis, and tatty liver disease. nat'l institute of diabetes and digestive and kidney diseases, do you know thb heal1h risks of being overweight (dec. 2007), http://win.niddk.nih.gov/publicationslhealth_risks.htm. 33. fact sheet, supra note 31, at 9. 34. g.a. colditz et al., weight as a risk factor for clinical diabetes in women, 132 a j. of epidemiology 501, 501-13 {2007) (nurses' health study data documenting association be­ tween diabetes and weight); g.a. colditz et al., weight as a risk factor for clinical diabetes mellitus in women, 122 annals of internal men. 461, 461-66 (1995) (nurses' health study data reveals that association between diabetes and weight starts at bmi of22); f.b. hu et al., diet, lifestyle and the risk of type 2 diabetes in women, 345 n. eng. j. med. 790, 790-97 (2001) (status ofbeing overweight increased risk of diabetes ten fold); ae. field et al., impact of overweight on the risk of developing common chrome diseases during a 10-year period, 161 archives of internal men. 1581,1581-86 (200l)(data :from health professionals fol­ low-up study, involving men, and the nurses' health study demonstrates that the risk of di­ abetes increases progressively as bmi increases); j.p. burke et al., a population perspective on diabetes prevention: whom should we target for preventing weight gain, 26 diabetes care 1999, 1999-2004 (2003) (risk of diabetes for overweight mexican-americans is 2. 7 times those with normal weight and risk of diabetes for non-hispanic overweight whites four times greater than normal weight); m.p. st-onge et al., metabolic syndrome in normal weight americans: new definition of the metabolically obese, normal weight individual, 21 diabetes carb2222, 2222-28 (2004) (association ofbmi and metabolic syndrome which consists of risk factors for diabetes, hypertension and dyslipidemia). 35. am. diabetes assoc., http://www.diabetes.org (last visited apr. 14, 2009). 36. coming epidemic oftype 2 diabetes in young adults, science daily, july 12,2008, http://www.sciencedaily.com/releases/2008/07/080708193249.htm (quoting endocrinologist joyce lee of the university of michigan c.s. mott children's hospital) (hereinafter coming epidemic]. 37. jd. 38. /d. 39. /d. "recent studies suggest that there have been dramatic increases in type 2 diabetes among individuals in their 20s and 30s, whereas it used to be that individuals developed type 2 diabetes in their late 50s or 60s." jd. 2009] slayjng me hydra 211 2. pre-diabetes approximately fifty-seven million people in the united states have pre­ diabetes.40 pre-diabetics have high blood glucose levels, just not high enough to be warrant the diagnosis of diabetes.41 however, pre-diabetics have an in­ creased risk of developing type ll diabetes, heart disease and stroke.42 "adults with pre-diabetes are at more than ten times the normal risk for developing di­ abetes and twice the risk for heart attack or stroke. '.43 progression to diabetes is not inevitable; "[ s ]tudies have shown that people with pre-diabetes who lose weight and increase their physical activity can prevent or delay diabetes and return their glucose levels to normal.'m for example, participants in a program run at a ymca that was designed to pro­ mote life-style changes to help prevent disease took a series of sixteen classes on "building knowledge and skills for goal setting, self-monitoring and problem solving.'o4s the participants bad significant, long-term weight loss, a substan­ tial decrease in the risk of developing diabetes and a marked decrease in choles­ terol levels. the ymca has approximately 2,500 facilities serving approximately 10,000 communities in the inner city, suburban and rural areas. the ymca, and other similar organizations which have long histories of suc­ cessful implementation of health promotion programs, are ideally situated to reach many individuals with pre-diabetes. however, it appears that many overweight pre-diabetics are being lured away from making these types of ma­ jor lifestyle changes by deceptive, quick-fix weight loss products.46 3. cardiovascular disease there are over eighty million americans who struggle with atherosclero40. fact sheet, supra note 31, at 4. 41. id at 3. 42. id 43. dance to the music: learning and exercising at ymca can prevent diabetes, new study says, science daily, sept. 11,2008, http://www.sciencedaily.comlreleases/2008/09/080909074058.htm. [hereinafter dance to the music]. 44. coming epidemic, supra note 36. 45. dance to the music, supra note 43. this program was part of a study involving the enrollment into two groups of ninety-two individuals at a ymca. the intervention group at­ tended sixteen classroom meetings which "focused on building knowledge and skills for goal setting, self-monitoring and problem solving. the control group was given standard diabetes prevention advice." id at a follow-up visit held four to six months afterwards, the intervention participants had decreased their body weight by six percent, while the controls had only de­ creased by two percent. this translates into a mean weight loss of 12.5 pounds for the interven­ tion group and two pounds for the control group. the weight loss in the intervention group was clinically significant as was their decrease in cholesterol these differences persisted at a twelve to fourteen month follow-up. id 46. see infra notes 60-64 and accompanying text. 212 indiana realm law revmw [vol. 6:203 sis, stroke, hypertension, coronary artery disease and hypertension.47 over one million new cases of heart disease are diagnosed yearly48 and there is a direct link between heart disease and being overweight 49 the odds ofheart disease, hypercholesterolemia and hypertension are significantly increased for those who are overweight. 50 in addition, a higher bmi during childhood is associated with an increased risk of heart disease in adulthood. 4. cancer in 2007, the american institute for cancer, along with the world cancer research fund, corroborated studies that demonstrated that individuals who are overweight are at an increased risk of certain types of cancer, including cancers of the kidneys, esophagus, pancreas, endometrium, uterus and ovaries, as well as colorectal cancer, esophageal adenocarcinoma and postmenopausal breast cancer and non-hodgkin's lymphoma. 51 47. am. heart assoc. & am. stroke assoc., heart disease and stroke statistics: 2008 update at a glance 2 (2008), http:llwww.americanheart.orgldownloadablelheart/l200078608862hs _ statso/o202008.final.pd£ 48. /d. 49. w.c. willett et al., weight, weight change, and coronary heart disease in women, 273 jama46l, 461-65 (1995)(riskofcoronary heart disease in women increased progressive­ ly with increased weight with risk doubling when becoming overweight); e.b. rimm et al., body size and fat distribution as predictors for of coronary heart disease among middle­ aged and older men, 141 am.j.epidemiolooy1117, 1117-27(1995)(findingsformensimilar to findings for women with risk of coronary heart disease doubling when becoming overweight); j.w. anderson et al., obesity and disease management: effects of weight loss on comorbid conditions, 9 obesity research 326, 326-34 (2001 supp.) (same); r.h. eckel et at., american heart association call to action: obesity as a major risk factor for coronary heart dis­ ease, 97 c1rculation2099, 2099-2100 (1998)(same); a.e. fieldetal.,lmpactofoverweight on the risk of developing common chronic diseases during a i 0-year period, 161 archives of internal med. 1581, 1581-86 (2001) (data from health professionals follow-up study involving men and nurses' health study demonstrates that the risk ofhypertension, hypercho­ lesteremia and heart disease is significantly higher when overweight); p.w.f. wilson et al., overweight and obesity as determinants of cardiovascular risk: the framingham experience, 162archivesofinternalmed.1867,1867-72(2002)(same); l.jansenetal., waist circum­ ference and not body mass index explains obesity-related health rislc, 79 am. j. ofcun!cal nutrmon 379, 379-84 (2004); j.l. baker, childhood body-mass index and the risk of coro­ nary heart disease in adulthood, 357 new eng. j. med. 2329, 2329-37 (2007). 50. see sources cited supra note 49. 51. am.inst.forcancerr.esearch&worjdcancer.r.esearchfund,bodycomposi­ tion, growth and development: body fatness, in food, nutrition, physical activity, and 1lje prevention of cancer: a global perspective 210 (2007), http://www.dietandcancerreport.org; e.e. calle et al., overweight, obesity and cancer: epide­ miological evidence and proposed mechanisms, 4 narure 579, 579-91 (2004) (evaluating the association between weight and risk of cancer based on a literature review of current epidemio­ logical studies); e.e. calle et al., overweight, obesity, and mortality from cancer in a pros­ pectively studied cohort of u.s. adults, 348 n. eng. j. med. 1625, 1625-38 (2003) (as bmi increases, so does the overall risk for cancer); centers for. disease control and prevention, nchs data on cancer, http://www.cdc.gov/nchsldata/filctsheets/cancer.pdf. 2009] slaying the hydra 213 ill. the growili of the weight loss supplement industry consumers in the united states have been exposed to a steady diet of in­ formation regarding the relationship between weight and disease. the major networks' nightly news shows, the popular morning shows good morning america and the today show as well as the powerhouse oprah show, repeat­ edly air stories explaining this relationship. consumer surveys confirm that the vast majority of americans who are overweight understand the link between being overweight and increased health risks for serious chronic conditions. 52 in fact, the primary motivation to lose weight for many is to improve their health to avoid or mitigate these health risks. 53 as the result of prodigious marketing campaigns, both adults and adoles­ cents are turning to weight loss supplements being marketed as dietary supple­ ments to either aid in their weight loss efforts or as an alternative to diet modification and exercise. 54 advertisements for the 'quick-fix' product that works to melt off pounds without diet or exercise, some even while you sleep, are everywhere. 55 enforma natural products, inc. ran an infomercial marketing its product exercise in a bottle claiming it "helps your body bum more calories while you're just standing or sitting around doing nothingeven while you are sleeping" and "[y ]ou can enjoy all those delicious foods like fried chicken, piz­ za, cheeseburgers, even butter and sour cream, and stop worrying about the weight. "56 the manufacturer of a similar product called maxiline advertised heavily by taking out full-page newspaper advertisements stating "[ s ]leep ... and lose weight in just a few nights ... you eat whatever you want."57 the ad­ vertisement stated that the product worked because "the body's fat cannot de­ fend itself from attack while asleep.'.s8 commercials on television and radio, lengthy infomercials, magazine ad­ vertisements, mass mailings ofbrochures and amway and "avon-calling" type visits from friends and neighbors hawking miracle potions for magical weight 52. ctr. for survey andresearchanalysis& ctr. for weiohi'loss, the landmark survey (2006), http://www.csra.conn.edu/pdf7natiooal_ dietary_ survey.pdf(survey of approx­ imately 12,000 households and in-depth interview of sample of3,500 individuals perfonned by centers at the university of connecticut and the university ofpennsylvania, respectively) [he­ reinafter the landmark survey). 53. !d. ( 43% stated that their goal in losing weight was to improve their health while only 10%were motivated to improve their appearance). 54. statement of director heinrich, gao, supra note 6, at 3. these products claim to cause weight loss by increasing energy expenditure, changing carbohydrate metabolism, increas­ ing a feeling of satiation or decreasing appetite, increasing fut oxidation, reducing the accumula­ tion of fat, or blocking the absorption of fat. h.m. blanck et al., use of non-prescription dietary supplements among americans is common, 107 j. am. dietetic assoc. 441,441-47 (2007); p .a. sharpe et al., availability of weight-loss supplements: results of an audit of re­ tail outlets in a southeastern city, 106 j. am. diet. assoc. 2045, 2045-51 (2006). 55. anthony, supra note 14. 56. !d. 57. !d. 58. !d. 214 indiana healm law review [vol. 6:203 loss flood the american consciousness. 59 in 2000, the sale of weight loss sup­ plements in the united states reached $4.7 billion, 60 with a projected increase of ten to twenty percent annually. 61 in the book through the looking glass, alice said, "[ o ]ne can't believe impossible things.'.62 the white queen answered: "i daresayyou haven't had much practice .... when i was your age ... i've believed as many as six im­ possible things before breakfast.',63 like alice, for many, the impossible weight loss claims made by the current breed of snake oil salesmen defy credi­ bility.64 however, viewed in context, these beliefs are more understandable. many of these consumers, and, shockingly, their physicians, incorrectly believe that the fda requires premarket testing to establish that these weight loss sup­ plements are both safe and effective.65 in fact, the fda does not require that these products undergo clinical testing for safety or efficacy prior to being 59. !d. "many egregious claimsparticularly for weight loss products -often appear in the mainstream media. major national newspapers, magazines, television, cable and radio sta­ tions seem too ready to accept the substantial advertising dollars of this industry without ques­ tion, often airing patently fraudulent ads with claims of extreme, instant, effortless weight loss. . • . ads promising as much as ninety-three pounds of quick and easy weight loss without dieting, ran in magazines like cosmopolitan, esquire, mccall's, redbook, and women's day, in major newspapers like the atlanta journal-constitution, the denver rocky mountain news and usa today as well as "smart source," a coupon-insert publication." id. 60. consumer healthcare prod. assoc., supra note 9. 61. statement of director heinrich, gao, supra note 6, at 1. in their desperation to lose weight, many consumers will try one product after another. blanck et al., supra note 54, at 441-47. 62. lewis carroll, through the looking glass (1865), reprinted in lim complete works of lewis carroll 184 (barnes & noble, 1994). 63. id. 64. the courts disagree over the standard that should be applied to detennine when claims are misleading. on one end of the spectrum, courts state that the pwpose of the fdca is "to protect the public, the vast multitude which includes the ignorant, the unthinking and the cre­ dulous who, when making a purchase, do not stop to analyze." u.s. v. 62 packages, more of less, ofmarmola prescription tablets, 48 f. supp. 878, 884 (w.d. wis. 1943); u.s. v. an article offood ... manischewitz ... diet thins, 377 f. supp. 746, 749 (e.d.n.y. 1974)(quot­ ing u.s. v. an articlenuclomin, 482 f.2d 581 (8th cir. 1973)) ("the test is not the effect of the label on a 'reasonable consumer,' but upon 'the ignorant, the unthinking and the credulous' consumer."). on the other end of the spectrum, other courts have held that the test is that of "purchasers who are of normal capacity and use that capacity in a common sense way." u.s. v. piraud, 1938 fdlijud. &admin. rec. 526,529 (s.d.n.y. 1949); u.s. v. two cases ofchlo­ ro-naptholeumdisinfectant, 217 f.477, 484(d.c. md. 1914). in2002, the fda announced that the standard that it will apply is the reasonable consumer standard. guidance for industry: qualified health claims in the labeling of conventional foods and dietary supplements, 67 fed. reg. 78002, 78003 (dec. 20, 2002) ("in assessing whether food labeling is misleading, fda will use a 'reasonable consumer' standard."). an interesting question is whether the "rea­ sonable person" standard used to assign fault, and thereby liability, in tort law is appropriate in a public health context when the mission of the fda is consumer protection. 65. of those physicians who had completed an internal medicine residency program, a stunning one-third were unaware that dietary supplements did not need premarket approval from the fda for safety and effectiveness. b.h. aschar et al., physicians' understanding of the regulation of dietary supplements, 167 arcidves internal med. 966, 966-99 (2007). 2009] slaying me hydra 215 placed on the market. 66 this vast market exists in spite of the fact that there is little to no evidence that most of these products actually work. 67 to the con­ trary, there is growing evidence that many are ineffective68 and unsafe.69 in 2002, the ftc issued a report that fifty-five percent of the claims made within advertisements of over-the-counter weight loss products were either false or misleading. 70 according to the ftc, more consumers are defrauded by weight loss products than any other product it has examined. 71 with tens of millions of pre-diabetics on the cusp of entering the vast ranks of those who already struggle with type ll diabetes, and with similar numbers battling cardiovascular disease and cancer, preventing quack weight loss products :from sabotaging consumers' efforts to lose weight by making the necessary life style changes in order to reduce their health risks must be a na­ tional public health priority. n. a history of fda regulation of deceptive and unsafe products: the transffion from post-market policing to pre-market prevention a look back through the history of the relationship between the fdca, the fda and predatory commercial interests adds a clarifying perspective to the argument that the fda currently has the authority to deal expeditiously with deceptive weight loss products to both remove those that are currently on the market and prevent others :from entering the market. over the 100 year history of the fda, congress has been steadfast in ba­ lancing the protection of individual choice in matters involving self-regarding behavior, such as food choices, with the need to protect vulnerable consumers 66. see infra notes 252-257 and accompanying text. 67. j.t. dwyer et al., dietary supplements in weight reduction, 105 j. am. dietetic assoc. 80, 80-86 (2005 supp.) (scientists at the national institutes of health opine that evi­ dence on the effectiveness of weight loss supplements is ''inconclusive at presenf'); r.b. saper et al., common dietary supplements for weight loss, 70 am. f amil yphyslcian 1731, 1731-38 (2004) (according to harvard medical school researchers, randomized clinical studies have never been performed on many weight loss supplements; in addition, ''no weight loss supple­ ment meet criteria for recommended use"); m.h. pittler et al., dietary supplements for body­ weight reduction: a systematic review, 79 am. j. cunjcal nutrition 529, 529-36 (2004) (little evidence exists to support claims that any dietary supplement works to reduce weight). 68. the common active ingredients contained in weight loss supplements are bitter orange, chromium, guar gum, hoodia, garcinia, conjugated linoleic acid, pyruvate, and chitosan. for each ingredient, there was either strong evidence of no effect on weight loss or inconclusive evidence. some of these substances have serious, toxic side effects associated with their use. for a chart of the most common weight loss supplement ingredients and attendant adverse reac­ tions, see statement of director heinrich, gao, supra, note 6, app. at 21-24. 69. id. 70. fed. tradecomm'n, weiohi'lossadver11sing:ananalysisofcurrent'i'rends 30 (sept. 2002), http://www.ftc.gov/bcp/reports/weigb.tloss.pdt: 71. consumer. fraud in tile united states: nm second ftc survey, supra note 13, at 15. 216 indiana health law review [vol. 6:203 from harm from third parties who are marketing health care products. 72 it has done so by linking the level of product regulation with the health status of the product's targeted population. accordingly, the greatest amount of regulatory protection has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual's struggle to return to normal health. 73 examples of products that fall into this category include drugs and devices. for these products, the modern fdca establishes a premarket enforce­ ment process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public. without premarket approval from the fda, these products will be deemed both adulterated and misbranded as a matter of law. conversely, the fdca requires less regulatory protection when products are targeted to healthy populations for use in maintaining or improving a nor­ mal state of health. examples of products that fall into this category are foods and narrow categories of functional foods and dietary supplements. for these products, the fda carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded. a review of the history of quack medicines supports this public health strategy. the late nineteenth and early twentieth centuries saw a remarkable growth in the marketing of sham products to treat and cure disease. at that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product this scientific lag time created a period when there was an information void that predatory commercial interests were quick to use to their advantage. as the fda carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial inter­ ests were able to profit from scientific uncertainty to the detriment of public health. during this long period in u.s. history, the curative claims of predatory sham medicine salesmen were limited only by the gullibility of their targets. in 72. in the context of the protection of public health, the line between the legitimate and illegitimate role of paternalism in government regujation is crossed when regujation moves from the prevention ofharm from third parties into the regulation of self-regarding behavior. (self­ regarding behavior consists of choices that impact the individual making the choices and not third parties). in this context, the harm from third parties is the provision of misleading infor­ mation to consumers who rely on this information in making health treatment or health mainten­ ance choices: the more unhealthy the consumer, the greater the degree ofharm that results from the provision of misinformation. for sham products, the harm is the delay in obtaining neces­ sary and effective treatment. for a product containing harmful ingredients, there is direct physi­ cal damage. the potential harm is less when misinformation is provided to consumers who are using the information to make choices on how to maintain or improve normal health. 73. whitakerv. thompson, 353 f.3d 947,951 (d.c. cir. 2004)("[b]ecausethehealthof diseased populations is particularly vulnerable, greater regulation may be justified for products intended for their consumption."). 2009] slaying the hydra 217 many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. the more dire the condition, the more vulnerable an individual was to the 'flimflam' of the greedy snake oil salesman. and the more dire the condition, the greater the degree ofhann when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. thus, this lag time between ini­ tial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product's safety and effectiveness was very costly in terms ofhuman suffering and loss of life. it took a series of highly publicized public health crises to create the polit­ ical will needed to pass legislation to close this 'space between' created by scientific uncertainty. this was accomplished by switching the burden of proof of safety and effectiveness from the fda and onto manufacturers. as more fully discussed in the following sections, it was not unti11962 that legislation was passed that required manufacturers to obtain premarket approval for new drugs from the fda by producing "substantial evidence" that the product is both safe and effective for its intended use. the drug amendments of 1962 allowed the fda to make the transition from its former inefficient and costly police role of enforcing specific statutoryprohlbitions by removing adulterated and misbranded products from the market, to its current gatekeeper role of pre­ venting those products from entering the market in the first place. thus, from 1962 until 1994, manufacturers were no longer able to 'play in the grey' and take commercial advantage of the scientific uncertainty over the safety and ef­ fectiveness of a product to the detriment of public health. the legislative history of the fdca makes it clear that congress also in­ tended that weight loss products fall into the same regulatory category as drugs and devices specifically to deal with predatory profiteering by product manufac­ turers that targeted a vulnerable population of those who were overweight or obese. in the legislative record, members of congress expressed their intent to deal with the massive number of ''worthless" products being marketed for weight loss at the time. thus, prior to the passage ofdshea and nlea, the fdca required that manufacturers of weight loss supplements obtain premar­ ket approval by establishing the safety and effectiveness of their products be­ fore distributing them. with the passage ofdshea in 1994, which allegedly shifted the burden of proof back onto the fda with relation to dietary supplements marketed to both healthy populations and vulnerable, unhealthy populations, predatory commercial interests are again being allowed to exploit scientific uncertainty. based upon an overbroad interpretation of the intent of congress in passing oshea, the door has been opened to the same deceptive advertising that ran rampant in the late nineteenth and early twentieth centuries. and unfortunately, tens of millions of vulnerable and desperate individuals who are overweight and at grave risk of developing a serious, chronic disease are being lured into this predatory playground. the united states has now come full circle andre­ turned to the era of the snake oil salesman. the very public health problem that 218 indiana health law review [vol. 6:203 the fdca was originally promulgated to deal with, fraudulent and deceptive products that put the nation's health at risk, has reared its ugly head once again. a. the rise of the quack remedy in the mid-nineteenth century, two-thirds of americans still worked on farms. 74 thousands of local mills ground grain and hundreds of small packing plants located in rural areas packaged locally produced foods. 75 by the end of the century, a majority of the nation had moved to the city, the number of mills grinding grain was exponentially smaller and operated on a much grander scale and the packaging companies were few and located in large cities. 76 locally produced foods were now shipped into the great maw of city factories, and returned in cans and jars, wa­ tered down, preserved and cheap .... the creation of goods en masse was soon matched by the ability to move them. great distances were shrunk by rapid transport. people who had once made food, clothing and medi­ cines, and simple tools for themselves or their neighbors, no longer did. the modern estrangement between the people who create goods and the people who consume them now emerged. 77 adulteration and deception were easy and profitable as manufacturers of food and medicines no longer had to face their customers.78 under laissez-faire regulation, corruption and abuse were rampant 79 food producers scammed consumers by adding fillers to food to increase weight (such as chalk, clay, or plaster of paris to flour and ground up insect carcasses, commonly lice, to brown sugar). 80 large amounts of untested chemicals (such as formaldehyde, sulfites, borax, salicylic acid and benzoic acid) were used liberally to preserve food for transport and to disguise the taste and appearance of food that was spoiled.81 74. phlujp j. hilts, protecting america's healtii 1ije fda. business, and one hundred years of reoulation 11 (2003). 75. id 76. id at 12. 77. id 78. food & drug admin., 1ije long struggle for 1ije 1906 law (june 1981), http://www.cfsan.fda.gov/-lrdlhistory2.html. 79. ld. at 21. 80. hilts, supra note 74, at 22. 81. id. at 21-22 ("copper sulfate can make faded vegetables appear green again; sodium benzoate can prevent decayed tomatoes from rotting altogether; stearins can stretch lard; borax can make odorous ham acceptable when canned."); richard m. coopbr, 1ije struggle for 1ije 1906 acr, in fda: a cenror.y of consumer. protection 28 (wayne l. pines ed., 2006) ("milk was one of the most adulterated products in america at the turn of the century; it was 2009] slaying the hydra 219 in the context of medicines, the nineteenth century was known as the ''grand era of the quack remedy," where medical fraud was perpetrated on a scale never before seen in this country. 82 medicine was split into the inadequate but seriously in­ tended treatment by doctors and the predatory commer­ cial medicine that had no basis but the desire for profit. and, as it happened, medicine was one of the first fully national markets that used nationwide advertising. quack medicines, of which there had always been a trickle, suddenly became a flood as tradesmen, not doc­ tors, saw the possibilities for profit. 83 a good example of one such quack remedy is swaim's panacea, which pictured hercules wrestling with the hydra as its logo. swaim's panacea claimed to cure "cancer, scrofula, rheumatism, gout, hepatitis, and syphilis.'.s4 these fake remedies hawked by snake oil salesmen were referred to as "patent medications," not because they were patented, but because their ingredients were labeled as "secret formulas.'.ss common ingredients included arsenic, cocaine, opium and alcohol. 86 it was commonplace to give teething infants me­ dications containing opium, which is thought to have cost tens of thousands of lives.87 these sham remedies grew in direct proportion to the rapid growth of in­ expensive newspapers and magazines and mass literacy. by the end of the ni­ neteenth century, manufacturers of patent medications were the largest advertisers in the country. 88 the ability to advertise also brought novel and ag­ gressive marketing techniques to bear. 89 with cheap postal rates for bulk mail­ ings, the direct to consumer advertising movement was born as manufacturers created simulated newspapers and pamphlets touting the curative power of their products. 90 operating in an area almost completely devoid of regulation, vast fortunes were made as the quack medicine man was free to prey on the despe­ rate and the vulnerable. a prominent historian captured the enormity of the frequently watered down and preserved with formaldehyde."). 82. hn.rs, supra note 74, at 23. 83. /d. 84. /d. at 24-25. another example is liquozone which was sold as a cure for .. everything from dandruff to dysentery, and contained 99 percent water and one percent sulfuric acid to give it a bite." id. at 48. 85. james harvey young, the medical messiahs: a social history of heal1h quack.eryintwentienicenlury .america 14 (1967) [hereinafter medical messiahs). 86. cooper, supra note 81, at 28. 87. /d. 88. /d. at 25. 89. /d. 90. /d. 220 indiana health law review [vol. 6:203 rewards that were reaped by these unscrupulous predators in the title of his book on the era, the toadstool millionaires.91 b. the pure food and drug act of 1906: a victory for predatory commercial interests the progressives of the early twentieth century recognized that phony medicines not only cheated consumers, these concoctions put consumers' health, and even their lives, at risk.92 the problem involved toxic ingredients as well as harmless, but ineffective, ingredients.93 if a proven remedy existed, a fake potion could divert or delay a consumer from seeking out necessary treat­ ment.94 in an attempt to deal with the problems of adulterated food and drugs, as well as rampant fraud, the pure food and drug act of 190695 was passed ban­ ning adulterated or misbranded food or drugs. 96 the 1906 act defined a drug as an article that is intended to "diagnose, mitigate, treat, cure or prevent" a dis­ ease and provided that labels on drugs could not be "false or misleading in any particular. "97 unfortunately for the chances of success of the 1906 act, the scientific understanding of the effects of purported cure-alls was in its infancy. consequently, little scientific data existed on either the effects of, or the health risks associated with, these products. this high level of uncertainty gave a de­ cided advantage to the quack remedy manufacturers as the 1906 act placed the 91. james harvey young, thetoadstoolmiluonaires (1961). 92. medical messiahs, supra note 85, at 29-32. 93. cooper, supra note 81, at 25-69. 94. id 95. federal food and drug act of1906, pub. l. no. 59-384,34 stat. 768 (1906) (com­ monly referred to as the "wiley act" or the "pure food and drug act'') [repealed by 21 u.s.c. § 329(a) (1938)); peter barton hutt & peter barton hutt ii, a history of government regula­ tion of adulteration and misbranding of food, 39 food, drug& cosmetics l.j. 2 (1984). 96. u.s. v. johnson, 221 u.s. 488,495 (1911); cooper, supra note 81, at 34-37. up­ ton sinclair's book, the jungle (1905), had a great deal to do with the passage of the pure food and drug act of 1906. the book provided graphic details regarding families who were struggling to live while working in the meat packing industry that were so disturbing that it made some readers sick while others wept. hilts, supra note 74, at 49. particularly disturbing were accounts of workers, sick with tuberculosis spitting onto the floor, then dragging butchered meat across it. there were tales of meat in storage rooms, rotting and covered with rat droppings, which was then made into sausage, detritus and all. there were even tales of workers who had fallen into the great acidic lard vat, and become, after their bones had been fished out, a part of 'durham's pure leaf lard.' id within weeks of the publication of the jungle, sales of meat dropped in half. !d. even after packing plants worked triple shifts to clean their plants for coming inspections, inspectors sent into the plants to investigate by teddy roosevelt were appalled by the filthy conditions. the public was outraged and the pure food and drug act that had been stalled in congress for years was passed in 1906. ld. 97. johnson, 221 u.s. at 495; cooper, supra note 81, at 34-37. 2009] slaying the hydra 221 burden of proof squarely on the shoulders of the fda to show that the problem product was unsafe or that its labeling was false. 98 this advantage was quickly realized when the fda first attempted to use its new authority under the 1906 act to pursue quack medicines. in united states v. johnson,99 decided in 1911, the united states supreme court handed the quack medicine industry a major victory. in johnson, the product at issue was dr. johnson's mild combination treatment for cancer, which allegedly cured almost any cancer. 100 the united states supreme court held that the 1906 act did not apply to therapeutic claims as the relationship between a pa­ tent medicine and disease cures was often a matter of conflicting medical opi­ nion and uncertainty. 101 with this case, the quack medicine industry was able to stake out a territory in which it would thrive for the next five decades. as long as there was scientific uncertainty over the effectiveness and safety of a "cure," the quack medicine purveyor could operate with virtual impunity. in a rapid response to the johnson decision, in 1912 congress passed the shirley amendment which banned misbranding claims on drug labels that were "false and fraudulent" regarding curative or therapeutic effect. 102 in reaction, the united states supreme court once again hobbled efforts to remove sham remedies by holding in seven cases of eckman's alternative v. united states103 that the shirley amendment required that claims be both false and fraudulent, regardless of how outrageous the claims of therapeutic benefit.104 after this decision, the government was required to establish an intent to defraud.105 this meant that manufacturers could defend by claiming that they had a good faith belief in their curative claims regardless of the lack of any evidence in support. the court in seven cases established a defacto license for the "ignorant no­ strum vendor who sold inefficacious drugs in good faith."106 consequently, predatory commercial interests claimed a victory in the court battles over the enforcement of the 1906 act. 98. johnson, 221 u.s. at 495; cooper, supra note 81, at 34-37. 99. johnson, 221 u.s. at 495. 100. !d. at 496. 101. id. 102. shirley amendment, ch. 352, 3 7 stat. 416 ( 1 912). see also cooper, supra note 81, at 17. 103. seven cases of eckman's alternative v. u.s., 239 u.s. 510 (1916) (product label made claims that the potion cured pneumonia and tuberculosis). 104. id. at 516. 105. id. at 516-18. 106. david cavers, the food, drug and cosmetic act of 1938: its legislative history and its substantive provisions, 6 law & confemp. probs. 2, 34 (1939). the seven cases decision also extended the length oftime that the quack medicine man could take advantage of scientific uncertainty. absent other evidence, a lack of a good faith belief could only be established when the science had reached that point in time when it was so well-developed that it would defy cre­ dibility that anyone could hold a good faith belief in the curative claims. as science moves in fits and starts, large amounts of time could pass before the degree of certainty over the health effects, both good and bad, of any product could be established to such a high level of certainty. 222 indiana healm law review [vol. 6:203 i. sham weight loss supplements under the 1906 act while the fda was able to win some cases involving the most obviously fraudulent concoctions for example colored water marketed to have curative abilities 107 critics of the 1906 act pointed out that some forms of quackery could not be prevented at all, such as quack concoctions ''promising to put flesh on the skinny or take it off the fat."108 this gap in the 1906 act allowed a mas­ sive growth in quack remedies for weight loss that started in the twenties109 when "[ s ]tyle decreed that men must be lithe and athletic and women slim to the point of emaciation. "110 in a speech titled "fraudulent advertising" given on the nbc network, then federal trade commissioner william e. humphrey stated that "[t]abulous sums are being spent for ... anti-fat frauds ... since the female skeleton has become the fashion of the country."111 a. marmolal riding this wave was a product called marmola, containing the dried thy­ roid gland of different animals and laxatives.112 advertising headlines for marmola included "beneath your fat a graceful figure dwells" and "famous beauties never get fat. "113 these advertisements explained that "grand ladies might indulge in a 'lifelong loaf,' drink liquor 'not illiberally,' and abandon 'table restraint,' all without the risk of obesityif they used marmola."114 these advertisements were convincing and sales ofmarmola soared.m ironi­ cally, these advertisements are the mirror images of modem-day products, like exercise in a bottle, discussed supra, that also claim that a person can consume calorie and fat-packed foods with abandon and still lose weight simply by taking a pill or a powder. . when physicians were using thyroid extracts for weight loss only in cer­ tain low-risk patients with great caution, the manufacturers ofmarmola were simultaneously advertising the use of thyroid extracts for everyone without res­ ervation.116 in 1928, the ftc (not the fda which was powerless to act against 107. cooper, supra note 81. 108. medical messiahs, supra note 85, at 54. 109. id at 123. 110. id. the editor of the journal of the american medical association wrote "[t]here seems, indeed, to have come upon the women of america a veritable craze for reduction which has passed the bounds of normality and driven women and young girls to a type of self­ mutilation impossible to explain on any other basis than the faddism of the mob." id 111. id 112. /d at 122. 113. id at 123. 114. id along with the advertisements came the testimonial of famous movie actress con­ stance talmadge: "'the demand for slender figures is so universal that movie stars must have them. not only beauty, but good health and vitality argue against excess fat.'" id. 115. /d. 116. id at 124. 2009] slaying the hydra 223 mannola under the 1906 act) brought suit claiming false advertising in mar­ mota i. m the ftc's expert physician witnesses explained that, even for ·the most healthy, thyroid preparations cany significant, serious side effects, and for many with other ailments, extra thyroid could be deadly.118 additionally, mar­ mota's advertisements claimed that "[p]eople used to think that excess fat all came from over-eating or under-exercise," in fact ''fat people, it was found, generally suffered from an under-active thyroid."119 to the contrary, the ftc's experts pointed out at trial that only five percent of people who were over­ weight owed their condition to low thyroid.120 so for ninety-five percent of overweight consumers, thyroid preparations would do no good.121 the manufacturer ofmannola was able to find expert physicians who tes­ tified that mannola was both safe and effective (several of whom later ex­ pressed contrition at being finagled into testif}ring).122 while the ftc prevailed at the trial court level, the decision was overturned on appeal as it was found that the issue ofmannola' s safety and effectiveness was a matter of conflicting medical opinion and uncertainty. 123 consequently, mannola remained on the market, even though it was ineffective for ninety-five percent of consumers and carried significant health risks for many others. just as was the case in johnson and seven cases, a predatory product manufacturer was able to take advantage of scientific uncertainty over the effectiveness and safety of a product at the expense of public health. thus, until1938, quack medicine men, like the man­ ufacturer ofmannola, continued to operate with almost complete freedom from regulation when it came to weight loss potions. deceptive and unsafe products flowed freely onto the market and profits poured into the pockets of the unscru­ pulous. as discussed infra, the hurdles that the fda faced in its attempts to re­ move mannola in the first part of the nineteenth century foreshadowed its al­ most decade-long battle to remove ephedra, a supplement for weight loss with many of the same unsafe properties as mannola, in the first part of the twen­ tieth century. 124 c. the food, drug and cosmetic act of 1938: the public health costs of the post-market policing of deceptive and unsafe products it took the elixir sulfanilamide crisis of 193 7, when over 100 people died mostly children to finally trigger the passage of a law to provide the fda 117. raladamco. v.fed. tradecomm'n,42f.2d430(1930),qtf'd,283 u.s.643 (1931). lis. raladam., 42 f.2d at 432-35. 119. medical messiahs, supra note 85, at 54. 120. id. 121. id. 122. raladam co., f.2d at 432, n.2. 123. id. at 432-35. 124. see infra notes 263-273 and accompanying text. 224 indiana health law review [vol. 6:203 with the tools to begin its fight against quack medications. 125 sulfanilamide was a new antibiotic that was successful for the treatment of disease-causing bacteria, most often venereal diseases and streptococcal infections that caused sore throats in children. 126 while effective, the taste of sulfanilamide was un­ pleasant and the large pills were difficult for children to swallow.127 the manu­ facturer added diethylene glycol creating a liquid form of the product which was both palatable and easy to swallow.128 the product was tested for taste, color and appearance, but not for safety.129 ''within weeks, scores of infants suffered slow, painful death as the diethylene glycoltoday' s antifreeze-pro­ duced irreversible liver toxicity."130 in response to the public outcry over this tragedy, congress enacted the federal food, drug and cosmetic act in 1938 to replace the 1906 act. 131 1. safety and efficacy under the fdca of 1938 under the fdca of 1938, "new drugs were required to be safe for the uses recommended in labeling."132 the fdca of 1938 provided for premarket notification, as contrasted with the modern day requirement of premarket ap­ prova/.133 under the 1938 fdca, a new drug manufacturer only submitted premarket notice called a new drug application (nda). if the fda did not ob­ ject within sixty days, the manufacturer was free to market the new drug imme­ diately.134 if the fda did object and requested information on the safety of the new drug, the manufacturer only had to produce a comparatively small amount of evidence to establish safety 135 that was based solely on the opinion of medical 125. j. richard crout et al., fda's role in the pathway to safe and effective drugs, in fda: a century of consumer protection 162 (wayne l. pines ed., 2006). the company produced 240 gallons of this product and shipped it to druggists all over the country in 4 ounce bottles. hilts, supra note 71, at 91. a total of107 people died in the two months the product was on the market, most of them children. id. 126. hilts, supra note 74, at 89-93. 127. crout et al., supra note 125, at 163. 128. id. 129. id. 130. id at 162. 131. /d. 132. crout et al., supra note 125, at 162. 133. id according to the thinking at the time, the word "safe" inherently implied some sort of risk/benefit assessment of efficacy as well as risk. id no one in 1938 thought the safety standard required an extensive effectiveness evaluation. id. but in 1962, fda commissioner george larrick told congress that the fda had been reviewing new products for effectiveness under the 1938 safety standard. id when a drug presented serious toxicity, he explained, the agency would weigh the advantages of the drug against its disadvantages. id 134. /d. 135. while the importance of controlled, randomized, double-blinded clinical trials was fully realized by the late 1940s, in the early 1960s the pharmaceutical industry still did not apply clinical trials to the evaluation of new drugs. "instead they relied on small studies aimed at elucidating the mechanism of action or demonstrating a short-term phannacologic effect, such as 2009] slaying the hydra 225 experts based on anecdotal evidence.136 if the fda refused approval of the new drug, it was likely that the manufacturer would appeal this decision to the courts. the fda still carried the burden at trial of demonstrating that a product was unsafe or ineffective by proving that it was harmful or that therapeutic ad­ vertisements were misleading.137 and, until1962, there was no obligation to test a product prior to distribution for efficacy. 138 this meant that the under­ funded and under-staffed fda had to face the time and expense of a trial for every product it refused to approve or targeted after it was on the market 139 and, of course, the fda had to wait until the science had been sufficiently de­ veloped so that it could produce the evidence necessary to meet its burden of proof. this lag time provided the opportunity for profit at the expense of the consumer who was relying on an often times unsafe and ineffective product to meet his or her health needs. this 'harm first, removal second' inefficiency greatly weakened the fda's enforcement efforts and allowed numerous prod­ ucts to remain on the market that were detrimental to public health. 2. misrepresentations under the fdca. of 1938 the 1938 act also banned misleading labeling or advertising and pro­ vided that ''there shall be taken into account ... not only representations made or suggested ... but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations .... "140 medical disagree­ ment over efficacy was considered to be a material fact which must be dis­ closed.141 thus, if the claims for a product were not generally supported by medical opinion, this fact had to be disclosed under the 1938 act 142 this addi­ tion foreclosed the tactic that was used so successfully with mannola i under the 1906 act of producing one or two experts at trial whose opinion ran counter to general medical opinion in order to create the "difference of medical opi­ nion" dilemma focused on by the johnson and seven cases courts. 143 with the 1938 act, congress created the basic framework for the zone of regulatory protection that insulates vulnerable, unhealthy populations from prelowering blood pressure or relieving pain. the medical literature consisted largely of collected series of patients' case reports, a few small clinical studies, and review articles .... " !d. at 165. the fda's role was also limited. "in 1960, the agency had a small handful of medical officers, toxicologists, and chemists (and no statisticians) devoted to the review of drugs. the publically accepted standard for judging the effect of drugs at the time was the opinion of medical ex­ perts." ld. 136. id at 162. 137. id at 162-63. 138. ld. at 163. 139. crout et al., supra note 125, at 163. 140. federal food, drug, and cosmetic act, pub. l. no. 75-717,52 stat. 1040 (1938). 141. ld. 142. cavers, supra note 106, at2. 143. /d. 226 indiana health law review [vol. 6:203 datory commercial interests. this regulatory boundary was fully constructed by the 1962 amendments to the fdca and still exists today. 3. sham weight loss supplements under the fdca of 1938 finally, the 1938 act also gave the fda the tools to begin to chip away at the substantial percentage of quack medications advertised for weight loss which were already on the market. 144 the act provided for a greatly expanded definition of "drugs" to include not only substances intended for use in the cure, mitigation, treatment or prevention of disease but also all substances, oth­ er than food, intended to affect the structure and junction of the body.14s sena­ tor copeland, who sponsored the act, stated that the addition of"structure and function" claims to the definition of" drug" was added specifically to deal with, among other fraudulent products, the large number of products being marketed that made specious weight loss claims: the present law defines drugs as substances or mixtures of substances intended to be used for the cure, mitigation or prevention of disease. this narrow definition permits escape from legal control ... prep~~rations which are intended to alter the strrcture or some function of the body, as, for example, preptll'lltions intended tij reduce excessive weight. there are many worthless and some dangerous devices and preparations falling within these classifications. s. 2800 contains ample authority to con­ trol them.146 this regulatory expansion was an acknowledgment that increased regula­ tion was warranted not only to protect the vulnerable, unhealthy portion of the population, but also to protect desperate, overweight and obese individuals who were similarly vulnerable to deceptive advertising and ineffective products. 147 just as is the case today, many overweight and obese individuals were especial144. jd at 118. 145. u.s. v. bacto-unidisk, 394 u.s. 784, 794-95 (1969). 146. jd (emphasis added). this expansion also included claims to affect the structure and function of the body made by sleep aids, tranquilizers and by products that create recreational effects. nutrilab v. schweiker, 713 f.2d 335, 336 (7th cir. 1983)(dealing with weight control products) (quoting food, drugandcosmeticactof 1938: hearings on s. 1944beforea sub­ comm. of the s. comm. on commerce, 73rd cong. 2d. sess. 15-16 (1933) (statement ofwalter g. campbell, chief of food and drug adminstration)). 14 7. medical messiahs, supra note 85, at 118. for example, a creme called "reducine" that was advertised in true romances magazine in 1926, came under regulation for the first time. the reducine advertisements explained that, upon applying the creme to the body, "a harmless chemical reaction takes place during which the excess fat is literally dissolved away, leaving the figure slim and properly rounded, giving the lithe grace to the body every man and woman desires." /d. 2009] slaying the hydra 227 ly susceptible to being deceived into purchasing and ingesting sham 'magic bullet' weight loss products. by expanding the definition of drugs to include structure and function claims, congress recognized that this special vulnerabili­ ty justified the extra regulation of those sham products that targeted the over­ weight and obese. a. marmola ii after decades of effort, in 1943, the fda was finally able to successfully remove the weight loss product marmola from the market in marmola 11.148 foreshadowing the modern-day challenges that the fda faced in the ephedra weight-loss supplement litigation under oshea, 149 in order to contest marmo­ la's safety in 1941, the fda performed a survey of 2,000 members of the american college ofphysicians and called nineteen notable scientists as expert witnesses in order to establish that self-medication with dried animal thyroid glands to lose weight carried a significant risk of serious health consequences, including heart attack. the government also called numerous witnesses who had actually suffered severe health effects.150 in addition to calling several of its own expert witnesses, the defense of marmola included allegations that the government was engaged in a power grab by trying to take away the individual's "inalienable right'' to self­ medication.151 a man named royal lee, the manufacturer of marmola, claimed that the government was conspiring with the american medical asso­ ciation to limit access to all medications except through a prescription granted by paying money to a doctor.152 this defense would later tum into the "free­ dom of choice" slogan used in the massive lobbying efforts that culminated in the passage ofdshea in 1994.153 four years after the institution of the cause of action in marmo ia ii, after an expenditure of ''uncounted thousands of dollars ... and hundreds of hours by legal and medical experts[,]"and after fighting an appeal up to the united states supreme court, the fda prevailed and the marmola saga was at an end.154 next, the fda began the same elaborate preparation and expense to litigate cases against other major players.m "with personnel short andre­ sources scanty, the fda could in any fiscal year work up only a relatively few 148. id. at210-15; u.s. v. 62packagesofmarmolaprescription tablets,48 f. supp. 878 {w.d. wis. 1943). 149. see infra notes 263-273 and accompanying text. 150. medical messiahs, supra note 85, at 212-16. 151. ld. 152. ld. 153. see infra notes 208, 212, 248-251 and accompanying text. 154. medical messiahs, supra note 85, at 212-16 155. id 228 indiana health law review [vol. 6:203 important cases in the fringe area of self-medication. many promoters of du­ bious drugs and devices were left to wait their turn. " 156 d. safety and effectiveness and the kefauver-barris amendments of 1962: the public health benefits of pre-market prevention once again, a crisis gave the impetuous for change. thalidomide was widely distributed in germany, japan and the united kingdom for sedative purposes and for the treatment of nausea in pregnancy for several years. in 1960, williams. merrell company, the manufacturer of the american version of thalidomide, kevadon, applied for fda approval.157 however, it was clear to dr. frances kelsey, one of the fda officers examining the application, that the drug had not been adequately tested for safety before distribution.158 in spite of pressure to approve the drug placed by the manufacturer on both the fda and dr. kelsey individually, dr. kelsey insisted that the drug needed ad­ ditional testing to prove safety before fda approval could be granted.159 in 1961, dr. kelsey learned of a possible connection between nerve damage in adults and thalidomide.160 she requested that merrell provide studies on the use of its thalidomide product on pregnant women.161 in 1962, it was discov­ ered that thalidomide was causing serious birth defects in children.162 while the application for thalidomide was pending for fda approval, hundreds of severely deformed babies were being born in germany.163 without the fda's knowledge, thalidomide had already been provided to 20,000 patients in the united states as part of a "investigational study. "164 in response to public outrage, the kefauver-hartis amendments to the fdca were passed which switched the burden of proof for safety and efficacy from the fda onto the manufacturers.165 under these amendments, the phar­ maceutical industry was required to test all new drugs for both safety and effec­ tiveness and to provide this testing data to the fda in its initial nda in order 156. id 157. crout et al., supra note 125, at 163. 158. /d. 159. /d. 160. /d 161. id 162. /d. 163. these babies were born with phocomelia, which is a greek word that combines the words 'seal' and 'limb.' medical messiahs, supra note 85, at416-17. a description of two cases of phocomelia provided a pediatric convention described "[p]hotographs and long bone x-ray pictures showed that the long bones of the infants' arms had almost completely failed to grow; their arms were so short that their hands extended almost directly from their shoulders. their legs were less affected but showed signs of a similar distortion of growth .... " id worldwide, it is estimated that 8,000 severely deformed babies were born because of thalido­ mide. hilts, supra note 74, at 154. 164. crout et al., supra note 125, at 165. 165. /d. at 163. 2009] slaying the hydra 229 to obtain premarket approval.166 the nature and weight of the evidence was also strengthened. these amendments required manufacturers to produce "substantial evidence" obtained through "adequate and well-controlled investi­ gations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved."167 in addition, "an elaborate regulatory system was established for investigational drugs that specifically includes a requirement that research subjects sign written informed consent forms. "168 e. the modern fda regulatory structure and the fda's gatekeeper role the kefauver-hartis amendments allowed the fda to transition to its modem role as the gatekeeper for the prevention of the marketing and distribu­ tion of unsafe and ineffective disease treatment products.169 this role allows the fda to operate at an exponentially more efficient manner, maximizing its ability to use its limited budget and staff to protect public health from unsafe and ineffective products targeted to vulnerable, unhealthy populations. with the 1962 amendments, congress optimized the zone of protection around the portion of the population that is exceptionally vulnerable as a result of their al­ tered health status in order to shield them from unsafe and ineffective products and to insulate them from predatory commercial practices. thus, until oshea was passed in 1994, manufacturers were no longer able to take advantage of the scientific uncertainty over the safety and effectiveness of a product to the de­ triment of public health. 170 as described earlier, under the current regulatory structure created by the fdca, the fda regulates products according to their intended use.171 to reite166. id. at 166-70. 167. ld. 168. id. at 170 169. the "agencies activities have changed from court enforcement of clear-cut statutory prohibitions to approval of products based upon an administrative choice among closely ba­ lanced alternatives in controlling advanced technologies." hutt & hutt, supra note 95, at 2. this gatekeeper role allowed public health considerations to play a larger role in fda decision­ making. in fact, the food & drug modernization act of 1997 added section 903 (b) which made the protection of public health the fda's primary mission. food & drug modernization actof1997, pub. l. no. 110-85, 121 stat. 823 (2007). 170. the 1962 amendments acted on knowledge gained from the food additives amend­ ment act of 1958 ("f aaa"). joseph a. levitt, keeping america's food supply safe, in fda: a century of consumer protection 140 (wayne i. pines ed., 2006). the f aaa placed the burden of proof on the manufacturers, rather than on the fda, to show that a newly discovered substance added to food is safe if used within specified quantities. id. this change fixed a ma­ jor flaw in the 1938 fdca that had placed the burden of proof on the fda to prove that a food additive was unsafe. id "this required substantial time, during which the industry could mar­ ket the potential injurious additions to the consuming public." id. 171. 21 u.s.c. § 321 (g)(1)(b)(1938); united states v. lane labs, 324f. supp. 2d 547, 556-69 (d.n.j. 2004) ("[t]he 'intended use' referred to within the fdca framework contem­ plates 'the objective intent of those legally responsible for the labeling of drugs.' 21 c.f .r. § 201.128. 'the intent is determined by such persons' expressions or may be shown by the 230 indiana heal til law review [vol. 6:203 rate, products that make disease claims or products that make structure and function claims are considered to be either drugs172 or devices.173 for drugs and devices, the modem fda relies on a premark:et enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process174 prior to distribution to the public.175 without premarket approval from the fda, these products will be deemed both adulterated and misbranded as a matter of law.176 on the other hand, products that are intended to be used as food are pre­ sumed to be safe and do not require premarket testing.177 little regulatory pro­ tection is needed from the government as thousands of years of use of traditional food provides consumers with the common knowledge, and thus the ability, to protect themselves from the ordinary risks associated with different traditional food products. this common knowledge and ability to self-protect supports the presumption of safety that is granted to traditional food under the fdca. if a particular food poses a safety risk over and above those which are circumstances surrounding the distribution of the article."'). see also united states v. storage spaces designated nos. "8" & "9", 777 f.2d 1363, 1366 (9th cir. 1985)("{i]ntent may be de­ rived or inferred :from labeling, promotional material, advertising, or any other relevant source."). 172. 21 u.s.c. § 32l(g)(l)(1994). see also lane labs, 324f. supp. 2dat556-69 (find­ ing products containing shark cartilage, rice bran and sand brier to be subject to fdca require­ ments for drugs as the products were advertised to treat cancer and human immunodeficiency virus); united states v. writers & researchers, inc., 113 f.3d 8, 11 (2d cir. 1997) (finding a homeopathic substance is subject to fdca requirements for drugs if it is promoted as a cure or treatment for existing disease, such as cancer, aids, or other diseases) .. 173. 21 u.s.c. § 321 (b) (1994). 174. 21 u.s.c. §355(a) (1994) and 21 u.s.c. § 360e (1994), respectively. 175. 21 u.s.c. §355(a) (1994) and 21 u.s.c. § 360e (1994), respectively. 176. see richard a. merrill, the archetecture of government regulation of medical products, 82 va. l. rev. 1753, 1761-76 (1996}. 177. katharine a. van tassel, the introduction of biotech foods to the to11 system: creating a new duty to identify, 72 u. cinn. l. rev.1645, 1651 (2004); statement of policy: foods derived :from new plant varieties, 57 fed. reg. 4706 (jan. 18, 2001) ("[m]ost foods derived from plants predate the establishment of national food laws, and the safety of these foods has been accepted based on extensive use over many years (or even centuries)"). con­ gress has defined "food" in section 321(f) as articles "used as food." ''this definition is not too helpful, but it does emphasize that 'food' is to be defined in terms of its function as food. rather than in terms of its source, biochemical composition or ingestibility." nutrilab, inc. v. schweiker, 713 f.2d 355 (7th cir. 1983). according to the lower court, the definition of food includes both the common sense definition and the statutory definition. the common sense definition is "articles used by people in the ordinary way most people use foodprimarily for taste, aroma, or nutritive value." id. the statutory definition expands this by adding gum. id. the court of appeals remarked, "[t]o hold as the district court did that articles used as food are articles used solely for taste, aroma or nutritive value is unduly restrictive as some products such as coffee and prune juice are consumed on occasion for reasons other than for taste, aroma or nutritive value." id. this debate appears to miss the mark as it is the use intended by the manufacturer that defines a product's regulatory category as a ''food" under the fdca, not the actual end use by the consumer. for example, if prune juice is marketed as a ''food," i.e. for taste, aroma or nutrition, it is a ''food" for the regulatory purposes of the fdca. h prune juice is marketed as a laxative, it is claiming to treat an abnormal health condition and it is a "drug" for the purposes of the fdca. unless there is exclusive use by consumers of prune juice for either purpose, the end use of the prune juice by consumers for taste, aroma or nutrition (as a food) or as a laxative is not relevant 2009] slaying the hydra 231 normally associated with a food product, such as salmonella in peanut butter, the fda carries the burden of proving that the food is adulterated or mi­ sbranded178 before it can be removed from the market. 179 v. a history of the dietary supplement health education act: the public health costs of returning the fda to post -market policing of deceptive and unsafe products in a series of skirmishes with the fda that began in the 1960s, the sup­ plement industry, which included the manufacturers of vitamins, minerals, ami­ no acids (some of which have nutritional value and some of which do not) and herbal remedies that have no nutritional value, fought for its products to be mi­ nimally regulated by the fda as food. the fda disagreed with this characte­ rization based on its view that, among other reasons, many of these products had no nutritional value and that the industry was making "structure and func­ tion claims" and "disease claims" that were targeting both healthy populations and vulnerable, unhealthy populations. this conflict ultimately resulted in a resounding victory for the supplement industry in the form of the vitamin amendments of 1976, the nutritional health education act of 1990 (nlea) and the dietary supplements health education act of 1994 (dshea). collec­ tively, these amendments to the fdca have been interpreted to strip the fda of its ability to prevent many deceptive and unsafe supplements from reaching the market. with regard to supplements, these regulatory roll-backs mean that the fda has been relegated to the ineffective and inefficient role as a post­ market policeman tasked with removing problem products from the market. unfortunately, the science on the safety and effectiveness of many of these products, especially herbal remedies, is uncertain. in a repeat of decades of past performances, predictably, predatory commercial interests were quick to move in and take advantage of this uncertainty. thus, the 1980s and 1990s marked the return to the era of the snake oil salesman. in 1994, when oshea was passed, there were 4,000 supplement products on the market. 180 by 2004, after deregulation, this number rose to 30,000, with a projection that 1,000 new products would be placed on the market every year. 181 supplements that are marketed for weight loss make up a substantial number of these products. and, as the ftc has pointed out, consumers are defrauded by supplements marketed for weight loss more than any other product the ftc has examined. 182 of the 1 78. van tassel, supra note 177, at 1651. 179. id. 180. fredh.degnan,creativeapplicationofthelaw:notmerelyacoilectionof words 171 (2d ed. 2006). 181. /d. at 173. 182. see supra notes 67-70 and accompanying text 232 indiana health law review [vol. 6:203 claims made in the advertisements of these products, 55% were either false or misleading.183 a. the supplement industry wins the battle over the regulation of vitamins the term "vitamin" was coined by casimen funk in 1911.184 by the 1940s, more than forty vitamins and other nutrients were discovered to be ne­ cessary to an adequate diet. 185 "the word 'vitamin' had acquired golden gla­ mour and the use of the word 'health' to market common foods was a theme 'so distorted and exaggerated' that one fda official lamented 'the magic words 'health giving' are today the most overworked and loosely applied in the adver­ tising lexicon. "'186 according to noted historian james harvey young, the 1938 act may have been one of the factors that triggered the growth of the sham vitamin and nutritional supplement industry. 187 by making traditional medical quackery more difficult, the field of nutritional deception appeared to be greener grounds. 188 add to this proposed explanation the fact that the body of science regarding the safety and effectiveness of quack medications was growing at an astounding rate. this growth acted to shrink the areas of uncertainty where the sham medicine man was able to make his profits. hence, a move by the quack medicine men into an area where there was greater scientific uncertainty made a great deal of business sense. moreover, consumers were vulnerable to alarm tactics that their health was at risk because of perceived problems with their diet as a result of the diet surveys of depression america and the food shortages ofwwii.189 the quack nutritional product purveyor exploited the publicity that came out of govern­ ment programs to enrich bread and other grain products and the publication in 1941 ofthe first "recommended daily allowances for specific nutrients."190 coupling the new public awareness of nutrition with folklore about foods, die­ tary supplement salesmen marketed their products based on the myth that al183. see supra note 70 and accompanying text. 184. james harvey young, american health quackery 168 (1992) [hereinafter american health quackery]. 185. id. by this time, a number of these vitamins and nutrients had been synthesized and marketed. id 186. !d. fda officials were so concerned that they "chastised the industry and warned the public" that health claims on product labels were convincing the public that "our ordinary diet is sorely deficient in such vital substances as vitamins and minerals, and that these so-called 'health foods' are absolutely necessary to conserve life and health." !d. fast forward to the state of the industry today to see that the phenomenon has repeated itself as the terms 'healthy' and 'natural' are equally ubiquitous. 187. id. at 170. 188. jd. 189. medical messiahs, supra note 85, at 333-59,401-05. 190. ld. 2009] slaying tiie hydra 233 most all disease was the result of improper diet 191 this marketing gambit is referred to generally as "the nutritional myth. "192 thus, scientific uncertainty, coupled with wlnerability, made for fertile grounds for the growth of the sham vitamin and nutritional supplement industry. comparatively little of this marketing was done on the product labeling because of the 1938 act.193 instead, analogous to current web and e-mail ad­ vertising, door-to-door salesmen pitched their products directly to consumers.194 for example, nutrilite had a sales force of20,000 and nutri-bio had a sales force of 75,000.195 the fda was able to win a number of cases by taping the outrageous health claims of the door-bell ringing salesmen.196 however, these victories were a very small percentage of the overall problem and did little to stem the tide.197 in the 1960s, 198 door-to-door sales decreased as health food stores prolife­ rated.199 radio and television talk shows grew in popularity as health food gu­ rus counseled the public on the intricacies of the nutritional myth, aroused anxiety over health concerns and insisted that the cure to a wide range ofhealth problems and diseases lay in the use of various herbs and vitamins. 200 hun­ dreds ofbooks were written with twisted views of the role that supplements and vitamins play in health. 201 for example, a common theme was that "cancer ... 191. j.r. bell, let 'em eat hay, 36 today'shealtii 22 (1958). 192. id. 193. americanhealmquacker.y,supranote 184, at 170. 194. id. 195. r.m.deutch, thbnursamongtiieberries215(1961). 196. medical messiahs, supra note 85, at 333-59,401-05. 197. id. an example of these products was catalyn which was a well-known and popular product created by royal lee, who would play a large role in the later fda vitamin battles. food and drug administration, report on me national healtii federation (1963). royal lee claimed that catalyn delivered vitamins a through 0 and could cure ''high and low blood pressure, bright's disease, dropsy and gouter." united states v. lee, 107 f.2d 522 (1939). after being convicted offidse and fraudulent claims under the 1906 food and drug act, royal lee reformulated the product and removed the disease claims from the product's labels. id he then produced pamphlets and circulars that made the same disease curing claims and directed his team of salesmen to hand them directly to the consumer at the point of sale. id this ruse eventually led to royal lee's conviction under the 1938 act as the product was con­ sidered to have been labeled with false and fraudulent disease claims when the pamphlets ac­ companied the product. united states v. lee, 131 f.2d 464 (1942). 198. at the same time, questions were being raised and congressional hearings were held on pesticide use and chemical additives in food. laws were passed to ensure premarket testing for safety was performed, but questions remained over the safety and ethics of the food processing industry as a whole. american healm quackery, supra note 184, at 173. "'these events ... occurred within a wider climate of suspicion: physicians, scientists, 'egg-heads' gen­ erally, surveys revealed, were regarded by a significant minority with antagonism. events be­ ginning in the following decade, from the vietnam war on through watergate, broadened and deepened mistrust of established leadership. health scientists continued suspect." id 199. deutch, supra note 195, at215. 200. m. gunther, quackery and the media, in s. barret & 0. knight, the healm robbers 285-300 (1976). 201. american healm quackery, supra note 184, at 172. 234 indiana realm law review [vol. 6:203 is a disease caused by a deficiency of b-17, pancreatic enzymes, or both.'.202 the nutritional myth also worked in efforts to target the sales of herbal reme­ dies to the obese and overweight 203 it was estimated that, in 1954, nutritional supplement sales reached a halfbillion dollars204 and consumers began to take vitamins in extremely high dosages and encountering serious side effects.205 in 1962, at the same time the thalidomide crisis was unfolding, the fda finally proposed regulations which would have created standards and upper limits for vitamins and mineral ingredients.206 in addition, the regulations would have required labeling to inform the consumer of the daily allowances and the fact that amounts over the daily allowances were not necessary to health. 207 in re­ sponse, the supplement industry was able to mobilize its constituents and spearhead a massive letter writing campaign directed at members of con­ gress. 208 in 1966, a new version of the regulations was proposed. 209 "mara­ thon" hearings ensued, creating 32,400 pages of transcript 210 ultimately, seven years later in 1973, a fmal version was announced. 211 in a repeat performance, the supplement industry mobilized and swamped congressmen with over two million letters, more letters than watergate, demanding that the fda be reined • 212 m. in 1976, the supplement industry prevailed and the vitamin amendments were passed213 which radically limited the fda's authority for the first time in 202. j.a. richardson & p. gluffen, laetrile case histories 6 (1977). 203. americanhealtiiquacicer.y,supranote 184,at 172. '"dietbookstakeupsome20 feet of shelf space' remarked a librarian in seattle's main public library, 'they are the most popular books we have.,,. id magazines and the sensationalist press added to the hype. id 204. /d. 205. nat'l nutritional foods ass'n v. mathews, 557 f.2d 325 (2d cir. 1977). the fda consulted with the food and nutrition board in order to determine ifthere was sufficient scien­ tific support for regulations governing ingredients, formulas, dosage and labeling standards for vitamins and nutritional supplements. 15 food drug & cosmetic reports 4 (feb. 20, 1954). the answer was that the science was still in its infancy and that there was still a high level of uncertainty over the health effects ofhigh doses of these vitamins and the use ofherbs, minerals and amino acids as nutritional supplements. consequently, the fda was left with the inefficient product-by-product enforcement tools. 16fooddrug&cosmeticreports2{nov. 27, 1954). getting wind of the fda's inclinations, a group of manufacturers of nutritional supplements and herbal remedies got together and formed the national health federation (''nhf''). food and drug administration, report on tile nationaliiealtiifederation (1963). many of its founding members were past targets offda litigation, including royal lee ofcatalyn fame. id borrowing from the defense used in the marmola litigation, the slogan of the nhf was "freedom of choice." see supra notes 151-53 and accompanying text. 206. degnan, supra note 180, at 170. 207. /d. 208. nat'l nutritional foods ass'n v. fda, 504 f.2d 761 (2d cir. 1974). 209. /d. 210. degnan, supra note 180, at 170. 211. final rule, 38 fed. reg. 20,708 (aug. 2, 1973). 212. nat'l nutritional foods ass'n v. mathews, 557 f.2d 325 (2d cir. 1977). 213. health research and health services amendments of 1976, pub. l. no. 94-278,90 stat. 401,410 (1976) (also referred to as the"proxmireamendments''). 2009] slaying the hydra 235 nearly seventy years.214 the vitamin amendments bar the fda from arguing that vitamins and minerals over a certain dosage are drugs merely because (over a certain amount) these products have no nutritional value. in other words, if a product has no nutritional value and so is not a "food," the vitamin amend­ ments instruct that the product does not automatically become a "drug.'m5 in addition, the fda is not permitted to limit the potency of vitamins and minerals on any grounds except safety. and, as is the case with products categorized as foods, the fda now shoulders the burden of proving that a vitamin or mineral is unsafe over a certain degree of potency. as the science was, at that time (and still is), evolving, the vitamin amendments began the process of reopening the 'space between' which allows predatory commercial interests the freedom to hawk massive doses of harmful and ineffective vitamins and minerals for health maintenance. with the passage of the vitamin amendments, the supplement industry took the first major step toward the recreation of a commercial playground where it could operate vir­ tually free of regulation as long as scientific uncertainty existed over the health risks and benefits of its products. b. the relationship between the arrival of functional foods and the dietary supplement health education act the 1980s brought in a new wave of health claims, this time relating to herbal remedies. unlike vitamins, minerals, and amino acids, herbal remedies have no nutritional value. some herbal remedies have been long used by many in attempts to treat disease. on the other hand, there were many who consi­ dered herbal remedies to be a type of food that supplemented the diet, like vi­ tamins. for this group, herbal remedies were used to stay healthy and avoid disease.216 regardless of the purpose for their use, one of the results of the mo­ bilization efforts of the 1960s and 1970s was the solidification of the view of many distributors that, just like traditional food, these herbal remedies were 'natural' and therefore safe.217 consequently, according to the supplement in­ dustry, just like traditional food, these herbal remedies should not be required to obtain premarket approval. 218 in a case of history repeating itself, many of these herbal remedies contained the same potentially toxic substances that were used in the patent medicine era, for example ephedra, dried animal thyroid (of marmo ia i and ii fame), dietary teas, lobelia, caffeine and penny royal. 219 before the 1980s, vitamins made up the vast majority ofthe supplement 214. degnan, supra note 180, at 171. 215. see supra note 213. 216. degnan, supra note 180, at 171. 217. scott bass, dietary supplements: populism and pirandello, in fda: a century of consumer protection 226-31 (wayne l. pines ed., 2006). 218. id. 219. fda advance notice ofproposed rulemaking, regulation ofdietary supplements, 58 fed. reg. 33,690, at 33,698-33,699 (1993). 236 indiana health law review [vol. 6:203 market. relative to today, herbal remedies played only a small role compared to the market for vitamins. thus, herbal remedies chiefly flew under the fda's regulatory radar.220 in the 1980s, the fda, with its limited staff and budget, was saddled with the necessity of bowing to the deregulation dogma of the reagan administration. consequently, the fda ignored many of the herbal remedies that generally seemed harmless and focused its attention on the most dangerous and the ones that made the most outlandish disease curing claims.221 as a result, there was an explosive growth in the herbal remedy industry and the scope ofhealth claims escalated.222 for example, st. john's wort was ex­ pressly marketed to treat depression. glucosamine condroitin was expressly marketed to treat arthritis. echinacea was expressly marketed to treat the com­ mon cold and flu. 223 by 1992, large corporations dominated the landscape as herbal remedies were cheap to make and could be sold for great profit. 224 by then, this part of the supplement industry had made a strategic transition in the nomenclature of their products from 'herbal remedies' to 'dietary supplements' to better argue that they should be minimally regulated like traditional food.225 it is unfortu­ nate that congress and the fda have adopted this terminology because it ap­ pears to have contributed to the confusion over appropriate regulation. as discussed in the next section, it was the push for enhanced fda regulation by the manufacturers of :functional food that resulted in herbal remedies (that have no nutritional value) being minimally regulated as food. 1. the national labeling and education act (nlea) also in the 1980s, as scientific discoveries began detailing the relation­ ship between diet and health, traditional food producers started making health claims, such as ''prevents cancer'' made by kellogg's all bran cereal226 or "prevents heart disease" made by quaker oats on its cereal. 227 these foods are popularly referred to as 'functional foods' because they allegedly function to protect against disease. 228 some food producers, like quaker oats, carried out serious research to substantiate their claims, but others simply jumped on the bandwagon.229 for example, a manufacturer of doughnuts sprinkled a little oat 220. id 221. margaret gilhooley, deregulation and the administrative role: looking at dietary supplements, 62 mont. l. rev. 85, 90 (2001). 222. bass, supra note 217, at223. 223. institute of medicine of tile national academies, complimentary and alternative medicine (2005) (hereinafter institute of medicine report]. 224. hilts, supra note 74, at 280..81. 225. bass, supra note 217, at 223. 226. fran hawthorne, thebusinf.ssandpouticsbehjndtiiei>r.ugswetakeandtiie food we eat 50 (2005). 227. hilts, supra note 74, at 262. 228. ld at 262-63. 229. id. 2009] slaying the hydra 237 bran on their product and then claimed a cholesterol reduction effect. 230 while, prior to nlea, these were clearly disease claims requiring premarket approval from the fda, consistent with its decision in the context of herbal remedies, the fda chose not to stop the marketing frenzy.231 the prevailing view of the regan administration was deregulation and the fda was politically relegated to dealing with only the worst of these claims. 232 with the fda sidelined, within a few years after the first health benefit claim was made by kellogg's in 1984, an estimated 40% of all new food prod­ ucts had made health or disease reduction claims.233 ''by 1989, it was estimated that one-third of the entire $3.6 billion spent on food advertising contained some health message.'.n4 while the fda sat virtually idle, the states geared up and actively sued for false and deceptive labeling against major, national manufacturers such as kel­ logg's, kraft and coca-cola. 235 under this era of deregulation, major manufac­ turers who distributed their products nationally were concerned that a patch­ work of fifty different laws would be created and that it would be impossible to conform to all with one label.236 a call for a uniform labeling law ensuring ho­ nesty and fairness came from both manufacturing and consumer groups fed up with deceptive health and labeling claims.237 paralleling this development, in 1988, the center for science in the public interest created a coalition of groups238 that recognized that detailed labeling on food could be used as an educational tool to promote a public understanding of the relationship between the maintenance of normal health and a healthy diet.239 in 1989, a major public health reform was introduced in the form of the na­ tional labeling and education act ("nlea").240 the bill called for detailed nutritional information, such as fat, calories, salt and vitamin content, to be listed on the label of foods. 241 nlea also required a complete listing of ingre­ dients.242 health claims were allowed under the nlea proposal, but were to be li­ mited to those which targeted people who had a normal health status and who wanted to improve their diet to maintain or improve that healthy status.243 for 230. /d. 231. /d. 232. /d. at 262-63. 233. /d. 234. /d . . 235. id 236. id 237. /d 238. id at 261. 239. /d. 240. degnan, supra note 180, at 171; national labeling education act, pub. l. no. 1001-635, 104 stat. 2353 (1990). 241. degnan, supra note 180, at 171. 242. /d. 243. whitakerv. thompson, 353 f.3d 947,950-52 (d.c. cir. 2004), cert. denied, 543 u.s. 238 indiana healm law review [vol. 6:203 example, an allowable claim under nlea is that a food product could help maintain a normal cholesterol level. 244 a claim to lower an abnormally high cholesterol level would be a prohibited disease claim triggering the premarket approval requirements. therefore, while a functional food could not claim to cure, mitigate or treat an existing disease (a disease claim), a product label that claimed that it could reduce the risk of a disease occurring in a healthy person (a health maintenance claim) was permissible.245 also, as a manufacturer was not making treatment claims, a lesser burden of proof of scientific support was required for functional foods than that which is applied to drugs. 246 thus, it is clear that nlea, which was passed in 1990, remains consistent with the long-held position of congress on the link between the level of product regulation and the health status of a product's targeted population. functional foods are targeted to the healthy portion of the population with the goals of health maintenance or the improvement of normal health, so less regulation is needed. on the other hand, if a functional food targets a vulnerable, unhealthy 925 (2004). 244. id 245. ld as pointed out in a recent citizen's petition infra note 306, at 22-28, nlea al­ lows claims that ingestion of food products may reduce the risk of developing a chronic disease. it does not appear that nlea will allow a health claim by the manufacturer of a weight loss supplement that the product will prevent the onset of a chronic disease. this is because the reduction of disease risk must be accomplished through the ingestion of an active ingredient contained in the product itselt: i.e. the substance itself reduces the risk. where the claim is that the product promotes weight loss, which then causes the reduction of disease, there are two separate claims being made: (i) 'eat my product and lose weight'; and then, (2) 'once you lose weight, your risk of developing a chronic disease is reduced.' it is the weight loss that reduces the risk of disease, not the product. eating the weight loss supplement will not reduce the risk of disease. thus, a claim that of 'eat my product and reduce the risk of disease' is a false state­ ment id 246. nlea authorizes the fda to approve "health claims" that a functional food can reduce a healthy person's risk of contracting a chronic disease "subject to a procedure and standard, respecting the validity of such claim, established by regulation of the secretary." 21 u.s.c.§ 343(r)(5xd) (1994). the fda promulgated regulations allowing health claims when a significant scientific agreement ("ssa ") has been reached regarding the existence of a diet-disease relationship. 21 c.f.r. § 101.14. the ssa requirement calls forrelevant and high quality studies that provide qualified scientists with a "high level" of comfort that the claimed relationship is scientifically valid. the fda also set up a sliding scale for a second category of claims referred to as "qualified health claims." id these are health claims that a food can reduce a healthy person's risk of contracting a chronic disease that do not have ssa to support them. id the fda will grant premarket approval for these claims if a dis­ claimer is provided so that consumers are not misled. the strength of the disclaimer is re­ lated to the amount of evidence there is to support the claim. id for example, a category b disclaimer may read "although there is scientific evidence supporting the claim, the evidence is not conclusive;" a category c claim may read "some scientific evidence suggests ... , however, fda has determined that this evidence is limited and not conclusive;" and a cate­ gory d claim may read "very limited and preliminary scientific research suggests ... fda concludes that there is little scientific evidence supporting this claim." if there is no credible evidence to support the claim, fda premarket approval will be denied. bass, supra note 217, at 225-31. the current state of the science is that there is no credible evidence to sup­ port the claims that any of the ingredients in weight loss products work to reduce weight 2009] slaying me hydra 239 population by making a "structure or function claim" or a "disease claim," it will be considered a drug and the stricter regulatory requirements will apply. 2. the dietary supplement health education act (dshea) the push to adopt nlea gave the fda the long-awaited opportunity to finally put to rest the question of the proper method for regulating herbal reme­ dies. thus, as proposed, nlea also covered herbal remedies that were being marketed as dietary supplements. nlea made it clear that these herbal reme­ dies would not be regulated like traditional food, but would have to obtain pre­ market approval to establish that they were safe and effective for their claimed uses.247 repeating the cycle, this attempt to regulate the supplement industry spurred a massive lobbying and public relations campaign to exempt all sup­ plements from nlea. 248 the supplement industry, which included the manu­ facturers of vitamins, minerals, amino acids and herbal remedies, was by this time dominated by large corporations with extensive marketing resources.249 a new group, the national health alliance (''nha") was formed to lobby con­ gress and launched a major marketing campaign based on fear and exaggera­ tion, claiming that the fda was trying to remove all supplements, including the public's cherished vitamins, from the market.250 the fda's protests that vita­ mins were not covered under nlea at all and that the fda's focus was on herbal remedies were to no avail.251 247. bass, supra note 217, at 225-31~ 21 u.s.c. § 355(d) (1994). 248. id at 225. 249. hn..ts, supra note 74, at283. 250. ld at 285. one flyer sent out to health food stores by the nha claimed: the fda wants to put you out of business ...• every health food store is under immediate threat of siege. congress wants to give the fda police powers so they can seize products without notification and use heavy fines and court penalties to close you down. fda wants to destroy your supplement business by making many items prescription only. fda wants to make it illegal to sell the majority of your best selling products. /d. action alerts were circulated claiming that the fda was trying to turn vitamins into prescrip­ tion drugs, that the fda was hiring 100 criminal investigators and that these new "o-men" would be unleashed on health food stores, individual citizens and the whole dietary supplement industry. id ''the industry fed money and materials to their supporters, including the ubiquit­ ous supplement stores. the campaign that was cranked up included radio and tv spots, fax blitzes, "hot lines" for call-in persuasion, celebrity videos, petitions, and "grass roots" lobbying kits. stores offered 20 % discounts on purchases if customers would send a letter of protest to congress. the store would supply the paper, the pencil and the language. the industry staged a nationwide "blackout" day in supplement stores, on which black draping was hung (over the products that industry claimed would be unavailable under the regulations) to draw media cov­ erage." /d. at 286. 251. the washington post commented that "'[t]he supplements battle has been wacky even by hill standards. the enormous lobbying effort against the labeling law ... was directed at an outcome loss of access to such remedies without a prescriptionthat the law never con240 indiana health law review [vol. 6:203 in spite of the fact that no scientific evidence was offered that herbal re­ medies were safer or more beneficial than other regulated products, 252 this pub­ lic relations blitz was so successful that, not only were all supplements excluded from nlea/53 congress passed the dietary supplement health edu­ cation act ("dshea"i54 that gave supplements an exemption from the fda's premarket testing and approval process entirely when supplements were mar­ keted to healthy populations. 255 this exemption covers supplements that carry labels with "statements of nutritional support" and statements explaining how a supplement may maintain or improve the "structure and function" of the body.256 oshea gives the nod to supplement manufacturers who have claimed for decades that their products should be regulated like food. the term "dietary supplement" now includes both nutritional and non-nutritional substances by embracing not only vitamins, minerals and amino acids, but also herbs or other botanicals which have no nutritional value.257 like nlea (but in the context of "structure and function claims'' rather than "health claims"), structure and function claims are allowed under oshea but are limited to those which target people who have a normal health status who want to improve their diet to maintain or improve that healthy status. for example, st. john's wort is permitted to claim to enhance normal mental health, glucosamine condroitin is permitted to claim to enhance healthy joints and echinacea is permitted to claim to enhance a healthy immune system. all three of these claims are that the products should be used to maintain or im­ prove a normal state of health. thus, as was the case with nlea, on its face oshea remains consistent with congress's long-held position on the link betained. '" !d. 252. id. at 284. 253. nlea exempts from§ 403(r)(3) "dietary supplements of vitamins, minerals, herbs or other similar nutritional substances." scotrbass&antiionyc. young, dietary supplement heal1h and education act: a legislative history and analysis 297, 300 (1996). 254. bass, supra note 217, at 226-31. dietary supplement health education act, pub. l. no. 103-417, 108 stat. 4325 (l994)(codifiedas amended in scattered sections of21 u.s.c.). under dshea, a dietary supplement is "a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; {c) an herb or other botanical; {d) an amino acid; {e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, meta­ bolite, constituent, extract, or combination of any ingredient described in clause {a), (b), (c), {d), or {e)." 21 u.s.c.§ 321(ft)(l) (1994). 255. gilhooley, supra note 221, at 95-99. 256. 21 u.s.c. § 321{g). seealyo 21 u.s.c. 343(rx6)(1994)(substantiationanddisclai­ mer for structure and function claims); fda final rule: regulations on statements made for dietary supplements concerning the effect of the product on the structure and function of the body, 65 fed. reg. 999 (2000). a dietary supplement can also include on its label a statement that "describes the role of a nutrient or dietary ingredient intended to affect the structure and function in humans" or that "characterizes the documented mechanism by which a nutrient or dietaryingredientactstomainttlin suchstructureorfunction." 21 u.s.c. § 343(rx6xa)(em­ phasis added). 257. dietary supplements do not include products that contain any other active ingredients such as synthetic ingredients that are regulated as over-the-counter medications or prescription drugs. statement of director heinrich, gao, supra note 6, at 3. 2009] slaying tiie hydra 241 tween the level of regulation needed and the health status of a product's tar­ geted population. vi. the impact of the dietary supplement health education act on the overweight and their risk for type ii diabetes, cardiovascular disease and cancer this review of the history of the fdca reveals that congress has been consistent in its position on the link between the level of product regulation and the health status of the product's targeted population. the 1906 food and drug act, the 1938 food, drug and cosmetics act, the 1962 amendments, nlea, and dshea have all dictated that less regulatory protection is needed when products are targeted to healthy populations for the purposes of health mainten­ ance and that the greatest amount of regulatory protection is necessary when products are targeted to vulnerable, unhealthy populations claiming to help them return to normal health. in just the past decade, it has been conclusively established that being overweight is a substantial and independent risk factor for serious diseases such as type ii diabetes, heart disease, and cancer. 258 overweight consumers clearly understand this link and are motivated to lose weight to avoid these risks. however, these unhealthy and vulnerable consumers are being lured away from legitimate weight loss programs by the sham, magic-bullet claims of weight loss supplement manufacturers. overweight consumers are purchasing these products in the belief that the fda has tested them for both safety and effectiveness, while the fda has taken the position that it does not have the power to require any premarket testing. a look at one example, the case of ephedra used as a weight loss supplement, clearly demonstrates why the current fda position will provide little protection to those overweight individuals who are being thwarted in their weight loss efforts by sham products. a. opening the door to predatory commercial practices: dshea and the case of ephedra as a result of the fda's interpretation ofdshea, weight loss supple­ ments are being regulated like traditional food products. as explained earlier, consumers have extensive experience of the risks associated with traditional foods. this common knowledge brings an ability to self-protect and supports the presumption of safety that is granted to traditional food under the fdca. 259 like traditional food, by virtue of the fda's interpretation ofdshea, weight loss supplements can now be placed directly on the market without any testing or premarket approval under a completely unsupported presumption of 258. see supra notes 31-51 and accompanying text. 259. van tassel, supra note 177, at 1651. 242 indiana health law review [vol. 6:203 safety.260 not only are supplements cloaked with a baseless presumption of safety, as if they were similar to traditional food, but oshea (as applied by the fda) also grants an equally unwarranted presumption that weight loss supple­ ments are effective as claimed. 261 currently, in order to remove an unsafe or ineffective weight loss supplement from the market, the fda carries the burden of demonstrating that the product poses a "significant or unreasonable risk of illness or injury."262 an example of the implications of switching the burden of proof onto the fda to prove that weight loss supplements are unsafe and ineffective is the case of a product called ephedra. ephedra contained ephedrine-alkaloid sup­ plements. 263 ephedrine alkaloids occur naturally in some plants, work as stimu­ lants and fall into the same category as the street drug referred to as "speed. "264 products containing ephedrine-alkaloid supplements were marketed for weight loss and to enhance sports performance.265 over time, the fda began receiv­ ing adverse event reports from consumers which included numerous complaints ofheart attacks, strokes, seizures and deaths associated with the consumption of products containing ephedrine-alkaloid supplements.266 one of the most highly publicized cases of a fatal consequence from the use of a product containing an ephedrine-alkaloid was the death of steve bechler, a twenty-three-year-old baseball player with the baltimore orioles.267 in a modem day version of the saga of the weight loss product marmola that occurred seventy years earlier,268 it took seven years for the fda to com­ plete its investigation of ephedrine-alkaloid supplements. the fda compiled an administrative record of 130,000 pages, 19,000 adverse event reports and engaged in extensive notice and comment before it passed a regulation banning the sale of ephedrine-alkaloid supplements in 2004.269 in this final rule, the fda stated that "[t]he best clinical evidence for a benefit ... supports only a 260. 21 u.s.c. § 32l(s) (1994 & supp. iii 1997) (exemption from food additive provi­ sions); nutraceutical corp. v. von eschenbach, 459 f.3d 1033, 1033-35 (loth cir. 2006), cert. denied, 127 s. ct. 2295 (may 14, 2007). 261. nutraceutical corp., 459 f.3d at 1039 n.5. ("the district court compared the lan­ guage ofdshea to the statutory language governing medical devices and drugs and concluded that, unlike manufacturers of medical devices and drugs, manufacturers of dietary supplements do not need to prove effectiveness prior to taking their product to market. the district court is correct.") 262. id. 263. nutraceutical corp., 459 f.3d at 1036. 264. barry a. palevitz, harmless energizers or dangerous drugs?, 161im scientist 1819 (2002) ("ephedrine is a close relation of amphetamine, sometimes called benzedrine. a little chemical tinkering creates the street drugs methamphetamine and ecstasy."). 265. nutraceutical corp., 459 f.3d at 1036. 266. ld. 267. hawrnorne, supra note 227, at 226. 268. see supra notes 112-124, 149-156 and accompanying text. 269. nutraceutical corp., 459 f.3d at 1036; final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present unreasonable risk. 69 fed. reg. 6788 {2004). 2009] slaying the hydra 243 modest short-term weight loss, insufficient to positively affect cardiovascular risk factors or health conditions associated with being overweight or obese.'.270 the manufacturer of ephedra filed suit arguing that the fda had failed to meet its burden of proof of showing that ephedrine-alkaloids were unsafe. 271 the district court found for the manufacturer. in 2006, the fda prevailed on appeal. 272 the total time and expense involved in this process, including the cost of the harm suffered by consumers, was tremendous. 273 vti. proposals for triggering the fda's premarket approval process to eliminate sham weight loss supplements placing the fda in a reactive rather than proactive position dooms the fda's efforts to safeguard public health in the context of weight loss supple­ ments. as the ephedra litigation demonstrates, 274 the fda does not possess the extraordinary resources that would be necessary to mount a comprehensive, post-market enforcement campaign to police the claims being made by the weight loss supplement industry. consequently, the fda has taken little sus­ tained action to remove ineffective and unsafe weight loss supplements from the market.275 the fda's overbroad interpretation ofdshea has allowed an exponential growth in the sale of supplements. there were 4,000 supplements on the market before dshea; after oshea, there are over 30,000.276 and the supplement industry is predicted to grow at a rate of 1,000 new products per year.277 many of these products make unsubstantiated and misleading claims and their safety is uncertain. 278 and a large number of these sham products are 270. nutraceutical corp., 459 f.3d at 1036. 271. id. at 1043-44. 272. id. at 1038-39. 273. the latest development in the ephedra story occurred in september of 2008 when a texas manufacturer, pump nutrition, placed an ephedra-like product back on the market. shane starling, supplement maker puts ephedrine back on market (sept. 22, 2008), http://www.foodnavigator-usa.com. byvirtueofthisgimmick,itappearsthatthemanufucturer could tap into the hype over ephedra contained in a wealth of publications and web pages simp­ ly by labeling their product as containing "ephedra." id if the product label made no claims relating to ephedra alkaloids, an argument could be made that it does not violate the fda regu­ latory ban. perhaps failing to realize this possibility, pump nutrition's product, "xp2g"lists ma huang and sida cordifolia as active ingredients, both of which contain the banned alkaloids. and it is marketed to promote weight loss. ld. 274. see supra notes 263-273 and accompanying text. 275. degnan, supra note 180, at 186. 276. degnan, supra note 180, at 185. the institute ofmedicine reports that consumers in the united states spend over $18 billion yearly on supplements. comm. on1heframeworkfor evaluating1hesafetyofdietarysupplements,dietarysupplements:aframeworkfor evaluating safety, institute of medicine, national academy of sciences (2004) .. 277. degnan, supra note 180, at 185. 278. the institute ofmedicine stated in a 2005 report that the safety of many supplements is uncertain. there is a dearth of data on safety coupled with a striking proliferation of unsubs­ tantiated and misleading claims regarding therapeutic benefit. institute of medicine report, supra note 223. 244 indiana health law review [vol. 6:203 supplements for weight loss. in an example of history repeating itself, snake oil salesmen with access to powerful, modem day marketing tools have returned in force. a close look at the history of the regulation of quack medicine, in tandem with the legislative history of nlea and dshea, provides persuasive evi­ dence that the fda has the authority under the fdca to require that weight loss supplement manufacturers obtain premarket approval for safety and effec­ tiveness before placing their products on the market first, dietary supplements marketed for weight loss make the type of structure and function claims that congress, in its legislative history, expressly considered to be drug claims when it passed the fdca in 1938.279 since 1962, products making drug claims are required to obtain premarket approval for safety and effectiveness. 280 second, weight loss supplements do not quality for the application ofdshea's safe harbor from the premarket approval requirements as weight loss supplements are not intended to maintain or enhance the structure and function of the body. 281 third, weight loss supplements do not qualify for "health claim" status under nlea as they are not intended to maintain health?82 finally, weight loss supplements make "disease claims"' as they ''purport to prevent or treat an ab­ normal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease.'.283 a. weight loss supplements and "structure and function claims" it is clear that congress created the separate and independent category of products intended to effect the structure and function of the body in large part because of the predatory profiteering by product manufacturers that targeted a vulnerable population of those who were overweight or obese.284 therefore, because weight loss supplements made structure and function claims they were considered to be drugs under the fdca. in the legislative record of the 1938 fdca, members of congress expressed their intent to deal with the massive number of''worthless" products being marketed for weight loss at the time. in 1962, congress expanded the protection of vulnerable consumers from harm by third parties by requiring that manufacturers of drugs and devices obtain pre­ market approval for safety and effectiveness.l85 thus, prior to the passage of dshea and nlea, the fdca required that manufacturers of weight loss sup­ plements obtain premarket approval by establishing the safety and effectiveness of their products before distributing them. 286 279. see supra notes 144-147,284-287 and accompanying text. 280. see supra notes 171-179 and accompanying text 281. see infra notes 288-297 and accompanying text. 282. see infra notes 298-305 and accompanying text. 283. see infra notes 306-319 and accompanying text. 284. see supra notes 144-14 7 and accompanying text. 285. see supra notes 169-179 and accompanying text. 286. see supra notes 144-14 7 and accompanying text. 2009] slaying the hydra 245 the question then becomes whether either oshea or nlea change this requirement as weight loss supplement manufacturers claim. at the core of this inquiry is the question of whether there is any basis for finding that the over­ weight and obese are less vulnerable today than they were when the fdca was originally passed. as the following sections discuss, both oshea and nlea were passed to enhance an individual's ability to choose to pursue a healthy diet by access to nutritional information about food in general and access to dietary supplements targeted to healthy populations to "encourage good health through the use of nutritional supplements .... "287 neither oshea nor nlea pro­ vide an exception (and any justification therefore) to the premarket approval process for products that target unhealthy, vulnerable populations. moreover, recent scientific studies both vindicate, and add to, congress's original assess­ ment of the level of vulnerability of those who are obese or overweight by de­ monstrating that the condition of being obese or overweight places an individual at high risk of serious, chronic diseases. 1. the limitations ofdshea 's safe harbor the stated goal of oshea is to enhance access to dietary supplements targeted to healthy populations so that these individuals can maintain their health through the use of nutritional supplements.288 in furtherance of that goal, oshea offers a safe harbor from the premarket approval requirement for dieta­ ry supplements that make "structure and function" claims that the dietary sup­ plement will either maintain or enhance the structure or function of the body. 289 thus, by its plain meaning, oshea only allows a manufacturer an exemption from premarket approval if its products are targeted to healthy populations for health maintenance or to enhance normal health. this interpretation is consis­ tent with the stated goals of oshea, with the events that led to the passage of oshea and with its legislative history.290 clearly, weight loss supplements are not products that are targeted to healthy populations for health maintenance. recent scientific studies have de­ finitively linked the condition of being overweight with a significant risk of a number of serious, chronic diseases such as hypertension, type ii diabetes, heart disease, stroke and cancer. 291 thus, it is clear that those who suffer from the condition of being overweight fall within a vulnerable, unhealthy popula­ tion. as such, when a weight loss supplement manufacturer targets its products to those with an overweight condition to help them alter the structure and func­ tion of their bodies in order to return to a healthy status, i.e. a healthy weight, weight loss supplement manufacturers are not targeting healthy populations to 287. bass, supra note 217, at 227. 288. id 289. 21 u.s.c. § 343(rx6)(a) (2007). 290. see supra notes 180-257 and accompanying text 291. see supra notes 31-51 and accompanying text. 246 indiana health law review [vol. 6:203 maintain or enhance the health of individuals with a normal health status, i.e. to help maintain a healthy weight. consequently, weight loss supplements do not fall within the safe harbor ofdshea this conclusion is consistent with strong historical evidence of the need to provide overweight individuals with additional regulatory protection from pre­ datory commercial interests until there is a greater scientific understanding of the safety and effectiveness of weight loss supplements. the history of quack medicines teaches that the need for regulation is at its height when there is a high degree of scientific uncertainty over the effectiveness and safety of new products intended to treat abnormal health conditions.292 time and events have established that there is a direct relationship between scientific uncertainty and predatory profiteering. this is especially the case when health care products are both marketed and sold directly to consumers without physician guidance. this is the current situation with weight loss supplements. at the present time, there is an information void on the efficacy93 and safety of the common ingredients contained in weight loss supplements.294 this information void is slowly being filled through scientific experimentation. with some of these ingredients, the level ofuncertainty'over their efficacy and health risks has progressed from indeterminacy (where scientists know what they don't know but can plan the scientific experiments necessary to find out) to a state of knowledge when classic probability analysis can be applied to as­ sess efficacy and predict risk levels to human health. thus, studies have shown that some of these substances are either ineffective or have serious, toxic side effects associated with their use. 295 on the other hand, with many of the other common ingredients, the science is too immature to draw any conclusions?96 compounding the scientific uncertainty is the fact that many weight loss sup­ plements are a mixture of multiple ingredients in various quantities. 297 as the body of science available to restrict the scope of weight loss claims is immature, absent regulatory intervention, the claims of supplement manufacturers are only limited by the gullibility of consumers. in many cases, the level of gullibility will be proportional to the level of desperation of the individual to lose weight. 292. see supra notes 12-179 and accompanying text. 293. dietary supplements that claim to aid in weight loss allege that they cause weight loss by increasing energy expenditure, changing carbohydrate metabolism. increasing a feeling of satiation or decreasing appetite, increasing fat oxidation, reducing the accumulation of fat or blocking the absorption of fat. see blanck et. al., supra note 54, at 441-4 7; p .a. sharpe et al., supra note 54, at 2045-51. 294. the common active ingredients contained in weight loss supplements are: bitter orange, chromium, guar gum, hoodia, garcinia, conjugated linoleic acid, pyruvate and chitosan. statement of director heinrich, gao, supra note 6, app. at 21-24. for each ingredient, there was either strong evidence of no effect on weight loss or inconclusive evidence. ld. some of these substances have serious, toxic side effects associated with their use. jd for a chart of the most common weight loss supplement ingredients and the attendant adverse reactions, see id. 295. /d. 296. id 297. ld. 2009] slaying the hydra 247 the more dire the weight loss need, the more vulnerable the individual will be to spurious claims. and the more serious the overweight condition, the greater the risk of harm when the weight loss supplement does not work and causes a delay in seeking help in making effective life style changes which causes chron­ ic conditions such as type ll diabetes, heart disease, stroke and cancer. as indicated above, congress was clear in its intent to provide overweight individuals additional regulatory protection from predatory commercial inter­ ests when it passed the fdca of 1938. absent some clear legislative fmdings that this group no longer requires this additional protection, along with an ex­ pressed intent that removes these protections, dshea' s safe harbor cannot be extended to cover weight loss supplements. instead, as congress originally intended when the fdca was passed, these products continue to fall into the same regulatory category as drugs and devices and premarket approval is re­ quired. b. the limitations ofnlea 's safe harbor this question was also laid to rest in relation to nlea in whitaker v. thompson. 298 in whitaker, a manufacturer of a product containing saw palmet­ to to treat the symptoms ofbenign prostatic hyperplasia submitted a petition for approval to the fda arguing that it was making permitted health claims under nlea. 299 nlea offers a safe harbor from the premarket approval requirement for foods and dietary supplements that make "health claims."300 health claims are claims that"[ c ]haracterize ... the relationship of any nutrient ... to a disease or health related condition."301 the fda denied the claim drawing a distinction between claims regarding the use of a prod­ uct to maintain health and to prevent' disease, on the one hand, and claims that a product could 'treat' a dis­ ease on the other. the former could qualify as 'health claims,' but the later would always be considered to be 'drug claims. '302 the court of appeals agreed with the fda's interpretation ofnlea finding "statements in the legislative history indicating that the purpose of the health claims provision was to promote long-term health maintenance and pre­ vention of disease .... "303 consequently, the court of appeals limited the 298. whitaker v. thompson, 353 f.3d 947 (d.c. cir. 2004}, cert. denied, 543 u.s. 925 (2004). 299. id. at 949. 300. id. 301. id. 302. id at 948. 303. id. at 951. 248 indiana health law review [vol. 6:203 scope ofnlea' s safe harbor to dietary supplements that target healthy popula­ tions by making claims that the product maintains a healthy state and prevents disease. 304 consistent with the whitaker decision, on multiple recent occasions, the fda has concluded that supplement products targeting individuals with ab­ normal health conditions such as high blood pressure, high blood glucose levels and high cholesterol levels are products that target vulnerable, unhealthy popu­ lations triggering the need for greater regulatory protection via the imposition of premarket testing requirements. 305 similarly, supplements that target individu­ als who have the abnormal condition ofbeing overweight are being marketed to wlnerable, unhealthy populations triggering the need for greater regulatory pro­ tection via the imposition of premarket testing requirements. c. weight loss supplements and "disease claims,, a recent citizen's petition filed with the fda suggests that the fda pur­ sue a new strategy to reclaim its power to protect overweight consumers from products that make sham weight loss claims. 306 instead of focusing on the claims of weight loss supplements as "structure and function" claims, it sug­ gests that the fda determine that "dietary supplement claims that they pro­ mote, assist, or otherwise help weight loss are 'disease claims"' as they "pwport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease. '.3°7 1. reduction of risk factor claims in 2000, the fda issued regulations that provided the industry with ten criteria that the fda planned to apply to determine whether a particular claim crossed over the line from being considered a permissible structure and func­ tion claim to an impermissible disease claim.308 according to one of these cri­ teria, a statement will be considered a disease claim if it asserts that the product at issue "[h ]as an effect on the characteristic signs or symptoms of a specific 304. id at 951-52. 305. see infra notes 308-317 and accompanying text. 306. this argument was first raised in a citizen's petition [hereinafter citizen's petition] filed with the fda on april 17, 2008 on behalf of an interesting quartet of petitioners who dis­ covered that they had joint interests. citizen's petition, at 15-20, http://www.obesity.org/news/ final_ petition_ 04 _ 22 _ 08.pdf. the petitioners included the american dietetic association, the obesity society, shaping america's health and glaxcosmithkline consumer healthcare, lp ('gsk"). the american dietetic association is "the nation's largest organization offood and nutrition professionals." id at l. the obesity society "is the leading scientific society dedicated to the study of obesity." id shaping america's health was "founded by the american diabetes association to reverse the obesity trends and weight loss issues." !d. gsk is the manufacturer of the weight loss product called allie. id 307. !d. 308. 65 fed. reg. at 1000. 2009] slaying the hydra 249 disease or class of diseases, using scientific or lay terminology.'.j09 in other words, if its intended use is to "prevent or treat abnormal or unhealthy condi­ tions or clinical measurements that are not themselves diseases but are markers of, or risk factors for, diseases.'.jjo for example, because "an elevated choles­ terol level is a sign of hypercholesterolemia and an important risk factor for heart disease,'m 1 any labeling that "as a whole implies that the product is in­ tended to lower elevated cholesterol levels" is a disease claim.312 thus, a dieta­ ry supplement that is intended to be used to reduce a risk factor for disease will be regulated as a drug and premarket testing will be required. other examples of impermissible "reduction of risk factor claims" include statements that a product will reduce high levels ofblood glucose or high blood pressure. the fda has found that a high blood glucose level is a risk factor for diabetes. 313 therefore, a claim to reduce high glucose levels is a claim to treat a risk factor for disease. 314 the fda has also found that high blood pressure is a risk factor for hypertension. 315 thus, a claim to reduce high blood pressure is a claim to treat a risk factor for disease. similarly, when weight loss supplements claim that they will return a consumer with an abnormal bmi to a normal bmi, they are claiming to treat a risk factor for serious diseases including, as dis­ cussed earlier, type ii diabetes, cardiovascular disease and cancer. the fda has also stated clearly that a factor in making its decision on whether a product is making a ''reduction of risk factor claim,'' triggering the need for increased regulation, is whether there is a link in the public's mind between the abnormal health condition and the risk of disease. for example, the fda has stated that "[l]owering cholesterol is inextricably linked in the public mind with treating elevated cholesterol and preventing heart disease.'.j16 in the landmark study, 94 % of the respondents recognized that being overweight increased the risk of diseases such as diabetes and cardiovascular dis­ ease.317 thus, weight gain and an increased risk of disease are linked in the public's mind. the fda's position on where to draw the line between permissible and impermissible claims is consistent with the goals of congress to limit the use of dietary supplements to the maintenance of a normal state of health. an exam309. 21 c.f.r. § 101.93(g)(2)(ii)(1994). 310. 64 fed. reg. 36,824,36,826 (julys, 1999). 311. 65 fed. reg. at 1019. 312. !d. 313. see, e.g., healing power, inc. courtesy letter (ltr. 885; may 23, 2006); usana health sciences, inc. courtesy letter (ltr. 879; may 3, 2006); anabolic laboratories, inc. courtesy letter (ltr. 782; sept. 29, 2004). 314. id. 315. see, e.g., new chapter, inc. courtesy letter (ltr. 935; apr. 3, 2007); new century company courtesy letter (ltr. 873; mar. 29, 2006); knature corp. courtesy letter (ltr. 807; feb. 4, 2005); now foods (ltr. 799; dec. 4, 2004); michael's naturoptbic programs courtesy letter (ltr. 730; oct. 15, 2003). 316. 65 fed. reg. at 1019. 317. see supra note 52 and accompanying text 250 indiana healtii law review [vol. 6:203 ple of a permissible claim is one that states that the product will "help to main­ tain cholesterol levels that are already within normal range."318 otherwise, sumers with abnormal health conditions that are risk factors for serious diseases may be lulled into a false sense of security, leading them to avoid a trip to the doctor that might result in a treatment or program that could correct the ab­ mal condition or prevent the condition from becoming worse. in the context of cholesterol, the fda has stated that the "use of possibly ineffective therapies in persons with elevated cholesterol, which can delay or prevent effective ment, poses significant health risk."319 just as the fda has found that it is of "compelling importance" to prevent heart disease through the use of drugs that have established that they are safe and effective in lowering cholesterol through clinical testing, it is of compelling importance to prevent type ii diabetes, hypertension, heart disease, stroke and cancer through equally safe and effec­ tive programs and treatments for weight loss. viii. conclusion the united states is at the beginning of an obesity crisis that, if un­ checked, will mean that 80% of the population will be either overweight or ob­ ese in a short fifteen years. the evidence is now overwhelming that there is a direct link between being overweight and the risk of serious diseases such as type ii diabetes, hypertension, stroke, cardiovascular disease and cancer. with regard to the risk of type ii diabetes alone, there are over fifty-nine million americans with pre-diabetes. studies have shown that progression to diabetes is not inevitable. consumers with pre-diabetes can prevent or delay diabetes if they lose weight and increase their physical activity. however, instead of making lifestyle changes that include diet modifica­ tion and exercise, overweight consumers desperate to lose weight are being lured by 'magic-bullet' claims into purchasing 'quick-fix' weight loss products in order to lose weight and decrease their risk for disease. many of these con­ sumers, and their physicians, incorrectly believe that the fda requires premar­ ket testing to establish the validity of these claims. taking advantage of consumers' vulnerability and misperceptions regarding fda oversight, weight loss product manufactures are generating stunning revenues. remarkably, ac­ cording to the ftc, the majority of these products are ineffective. like her­ cules and his attempts to slay the many-headed hydra, for every weight loss product that the ftc successfully removes from the market, it appears that do­ zens more are spawned. thus, u.s. consumers are being thwarted in their weight loss and disease reduction efforts and the obesity crisis continues to mu­ shroom. to date, the fda's position has been that it has no power to require pre318. 65 fed. reg. at 1019. 319. citizen's petition, supra note 306, at 15-20. 2009] slaying the hydra 251 market testing of weight loss supplements. yet. a close look at the history of the regulation of quack medicine, in tandem with the legislative history of the 1938 fdca, nlea, and dshea, strongly suggests that the fda has the au­ thority under the fdca to require that weight loss supplement manufacturers obtain prem.arket approval for safety and effectiveness before placing their products on the market. first, weight loss supplements make the type of struc­ ture and function claims that congress, in its legislative history, expressly con­ sidered to be drug claims when it passed the fdca in 1938. since 1962, products making drug claims are required to obtain prem.arket approval for safety and effectiveness. second, weight loss supplements do not qualify for the application ofdshea's safe hmbor from the premarket approval require­ ments as weight loss supplements are not intended to maintain or enhance the structure and function of the body. third, weight loss supplements do not qual­ ify for "health claim" status under nlea as they are not intended to maintain or improve normal health. finally, weight loss supplements make "disease claims" as they "purport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease. "320 in light of the obesity epidemic and recent scientific studies that have de­ finitively linked being overweight with the risk of a number oflife threatening diseases, this article concludes that it is time for the fda to reevaluate its posi­ tion and use its power to regulate weight loss supplements to require premarket approval for safety and effectiveness. requiring premarket approval results in a proper balance between the protection of individual choice in matters involving self-regarding behavior with the need to protect vulnerable consumers from harm from third parties by linking the level of product regulation with the health status of the product's targeted population. 320. id. access to health care as an incentive for healthy behavior an assessment of the affordable care act's personal responsibility for wellness reforms access to health care as an incentive for healthy behavior? an assessment of the affordable care act's personal responsibility for wellness reforms lindsay f. wiley' i. personal responsibility for wellness in the federal health law landscape ................ 642 a. personal responsibility for wellness: conditioning financial incentives on medical compliance, lifestyle compliance, and biometrics .... ..... 645 b. types of health -care coverage and federal regulation to ensure access............ ..... 647 1. private health insurance ................ 648 2. public programs ................... ..... 650 ii. the aca's personal responsibility for wellness provisions .............................. ....... 653 a. the 2013 rand report on workplace wellness programs.........................654 1. the prevalence and design of workplace wellness..............................655 2. the impact of workplace wellness programs.665 b. the group health plan wellness program exception .......................... ...... 666 1. the wellness program exception in hipaa ... 669 2. the 2006 wellness program rule ..... ..... 670 3. the wellness program exception in the aca .... 679 1 the author is an associate professor of law and director of the health law & justice program at american university washington college of law. the author wishes to thank the participants in the indiana health law review's 2013 symposium for their engagement and feedback on this project at an early stage when the rand report and 2013 rule had not yet been released, nick masero and jillian rubino for their research assistance, and the students in her spring 2013 and spring 2014 health law classes for grappling productively with wellness programs during a particularly grueling small group exercise. indiana health law review 4. the 2013 wellness program rule..... ..... 681 c support for small business workplace wellness programs. ........................... ...... 691 d. the individual insurance wellness program demonstration project...........................693 e. the medicaid incentives for prevention of chronic disease program............................694 1. federal restraints on the implementation of incentive-based personal responsibility for wellness medicaid programs.... .......... 695 2. medicaid wellness program waivers prior to the aca .......................... ........ 696 3. medicaid incentives for the prevention of chronic disease grant program .................. 701 4. post-a ca medicaid waiver decisions...............705 iii. conclusion ........................................ 708 hundreds of thousands of lives have been saved by vehicle safety standards. 2 for many years, the auto industry fought the adoption of even the most basic standards tooth and nail, arguing that driver responsibility was the key to preventing auto accidents. 3 in doing so, 2 see, e.g., nat'l highway traffic safety admin., rep. no. dot hs 809 833, lives saved by the federal motor vehicle safety standards and other vehicle safety technologies, 1960-2002 passenger cars and light trucks with a review of 19 fmvss and their effectiveness in reducing fatalities, injuries and crashes (2004) (finding that from 1968-2002 nearly 253,000 avoidable deaths in the united states were attributable to a defined subset of federal vehicle safety standards). 3 matthew t. lee, the ford pinto case and the development of auto safety regulations, 1893-1978, 27 bus. & econ. hist. 390, 394-95 (1998), available at http://www.thebhc.org/publications/behprint/ v027n2/p0390-p0401.pdf ("although the auto industry did little to encourage public discussion of auto safety issues, it was instrumental in framing this debate. . . . [t]he industry 'owned' the power to define the problem of auto safety and fixed political responsibility for deaths on driver behavior and road design rather than car design. . . . the 636 vol. 11:2 2014 aca's personal responsibility for wellness reforms 637 vehicle manufacturers "reinforceled] certain common sense ideas about traffic safety"-that drivers were responsible for car accidents and that vehicle design could not do much to make serious crashes survivable-"and suppressled] others."4 auto insurers-who bear much of the economic cost of car crashes through a combination of first party and liability insurance-initially joined auto manufacturers in pushing driver education and traffic safety laws over vehicle design standards. eventually, however, injury epidemiologists convinced the insurers that improved vehicle design promised greater safety gains and cost savings and thus drove a wedge between insurers and manufacturers.5 ultimately, the auto insurance industry played a crucial role in turning the tide against motor vehicle injuries by funding research to develop vehicle safety standards and lobbying to make them law.6 thirdparty payers have powerful incentives to reduce the costs associated with illness, injury, and property damage. they also have powerful influence on policymakers with regard to the law and policy strategies adopted for reducing those costs. industry's actions . . . effectively marginalized safety critics concerned with vehicle design."), archived at http://perma.cclz4es-5323. 4 id. at 395. 5 martin albaum, safety sells: market forces and regulation in the development of airbags 18 (2005), available at http://safetysells.org/contents.html (describing a shift in the auto insurance industry toward seeing "federal auto safety regulation as one way of stemming the inflation in insurance premiums" and a "move away from [insurers'] traditional reluctance to challenge the automotive establishment"). 6 about the institutes, highway safety research & commc'ns, http://www.iihs.org/iihs/about-us (describing the history of the insurance institute for highway safety and injury prevention epidemiologist william haddon's instrumental role in transforming it into an independent research organization pioneering the use of scientific methods to develop and test interventions to reduce "crash losses" rather than simply preventing crashes by altering driver behavior); david hemenway, while we were sleeping: success stories in injury and violence prevention 9-19 (2009) (describing the role of auto insurance companies in supporting injury prevention research and policy change). indiana health law review in the health insurance context, underappreciated provisions in the affordable care act ("aca")7 encourage third-party payers-employers, private health insurers, and public medicaid programs-to take a more active role in reducing health care costs by conditioning the terms of coverage on individuals' compliance with recommended health behaviors aimed at preventing heart disease, stroke, and cancer. champions of this approach, which i call "personal responsibility for wellness," argue that it could help halt rising health care costs and turn the tide against some of the most pressing public health problems of our time.8 employers exhibit enormous enthusiasm for programs that condition financial rewards and penalties (typically in the form of premium discounts or surcharges or differential cost-sharing through deductibles, co-pays, and co-insurance) on individual participation in wellness programs ranging from health screenings to weight loss counseling.9 the proportion of employers offering incentivebased programs has increased dramatically over the past few years.10 an annual survey of employers with 1000 or more employees indicates that in 2014 nearly 70% of them 7 patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119-1025 (2010). 8 see, e.g., katherine baicker et al., workplace wellness programs can generate savings, 29 health aff. 304 (2010) (metaanalysis concluding that workplace wellness programs improve health outcomes and reduce health care costs). chronic conditions (including chronic pain and mental health disorders as well as heart disease, stroke, and cancer) account for about 75% of health-care costs in the united states. see ctrs. for disease control and prevention, the power to prevent, the call to control: at a glance 2 (2009), available at http://www.cdc.gov/chroniedisease/resources/publications/ aag/pdf/chronic.pdf, archived at http://perma.cc/s8w8-z2tc. 9 the prevalence of wellness programs and their design features (including among smaller employers) are discussed further in part ii.a, infra. 10 see towers watson/national business group on health, 2014 employer survey on purchasing value in health care (2014), available athttp://www.towerswatson.com/en-us/insights/ic-types/surveyresearch-results/2014/03/towers-watson-nbgh-employer-survey-onpurchasing-value-in-health-care. [hereinafter 'towers watson survey"], archivedathttp://perma.cc/xk68-ft5l?type-pdf. vol. 11:2638 2014 aca's personal responsibility for wellness reforms 639 offered healthy behavior incentives." many employers are shifting away from incentives for participation alone toward incentives tied to the maintenance of particular health metrics or the attainment of particular results in a defined time period. as of 2014, 42% had adopted incentives tied directly to smoking status with an additional 16% planning to do so in 2015.12 twenty-two percent used incentives tied to biometrics like weight and cholesterol, with an additional 24% reporting that they planned to do so in 2015.13 at the same time, medicaid programs in politically conservative states have been experimenting with applying the corporate wellness program model to their medicaid populations, with mixed results. 14 critics of incentive-based personal responsibility for wellness programs are concerned that these programs may simply shift health care costs from third-party payers to individuals without resulting in better health outcomes.15 given that there is often a lapse of decades between behaviors like tobacco use, unhealthy eating, or physical inactivity and the health care costs associated with them,16 11 id. at 23. 12 id. at 22. 13 id. 14 see karen j. blumenthal et al., medicaid incentive programs to encourage healthy behavior show mixed results to date and should be studied and improved, 32 health aff. 497, 499 (2013). the prevalence and design of medicaid personal responsibility for wellness reforms is discussed further in part ii.e, infra. 15 john dinardo et. al., toward a scientific approach to workplace wellness: a response to ron goetzel, health affairs blog (july 1, 2013), http://healthaffairs.org/blog/2013/07/0 1/toward-a-scientificapproach-to-workplace-wellness-a-response-to-ron-goetzell, archived at http://perma.cc/z2ex-d87w. 16 see, e.g., william weiss, cigarette smoking and lung cancer trends:a light at the end of the tunnel., 111 chest 1414, 1416 (1997) (suggesting "an average latency interval between onset of smoking and lung cancer diagnosis of close to 50 years"), available at http://journal.publications.chestnet.org/data/journals/chest/21747/141 4.pdf, archived at http://perma.cc/s3x7-wxgv; j.g. eriksson et. al., catch-up growth in childhood and death from coronary heart disease: longitudinal study, 318 brit. med. j. 427 (1999), available at http://www.ncbi.n1m.nih.gov/pmc/articles/pmc27731/pdf/427.pdf indiana health law review and given that americans frequently move from one form of health care coverage to another over the course of a lifetime,' 7 third-party payers' interests may not be entirely well aligned with sound prevention policy. personal responsibility for wellness reforms aims to incentivize individual behavior change without necessarily facilitating it through environmental changes. by creating conditions hostile to those who are unhealthy (or are perceived as unhealthy due to their weight or other factors), reforms have the potential to encourage "lemon dropping" by driving unhealthy employees away from wellness-oriented employers while directly shifting costs to those who remain, in the form of higher premiums, co-pays and co-insurance. this approach threatens to undermine the aca's broader goal of promoting access to health care without regard to health status or risk factors. elsewhere, i have argued that personal responsibility reforms reflect cultural biases that exaggerate the extent to which ill health is attributable to the personal failings of unhealthy individuals and that they serve as a political distraction from less punitive measures aimed at making our communities, workplaces, schools, and marketplaces (linking death from heart disease in later adulthood to prenatal and childhood nutrition); 011i t. raitakari et al., associations between physical activity and risk factors for coronary heart disease: the cardiovascular risk in young finns study, 29 med. & scl. sports & exercise 1055 (1997), available at http://www.ncbi.nlm.nih.gov/ pubmed/9268963 (associating physical activity in childhood and young adulthood with blood cholesterol levels and risk of premature coronary heart disease during middle age). 17 erika c. ziller et. al., patterns of individual health insurance coverage, 1996-2000, 23 health aff. 6, 210 (2004), available at http://content.healthaffairs.org/content/23/6/210.full#r14 (describing high volatility in enrollment and disenrolment in the individual insurance market); robert seifert & amanda littell-clark, mass. medicaid pol'y inst., enrollment volatility in masshealth: a progress report (2013), available at http://bluecrossmafoundation.org/sites/default/files/download/publication/ enrollmentvolatilityinmasshealthfinal.pdf (describing high volatility in state medicaid enrollment). 640 vol. 11:2 2014 aca's personal responsibility for wellness reforms 641 more conducive to healthy living.18 here, i assess ongoing agency implementation of the aca's personal responsibility for wellness reforms and find cause for hope. this article describes and assesses ongoing federal agency implementation of aca personal responsibility for wellness provisions, including the 2013 workplace wellness programs study; the 2013 incentives for nondiscriminatory wellness programs in group health plans final rule; the individual insurance wellness program demonstration project; the small business workplace wellness grant program; and the medicaid incentives for prevention of chronic diseases grant program. the article proceeds in part i by situating the personal responsibility for wellness approach within the broader federal health law and policy landscape. in part ii, i describe the personal responsibility for wellness provisions included in the aca and the current state of agency implementation with regard to each. i argue that in implementing these provisions, the department of health and human services ("dhhs") appears to be taking an appropriately skeptical stance toward personal responsibility for wellness measures that use rewards and penalties to encourage, but not necessarily facilitate, healthier behavior. i conclude by arguing that recent agency actions are a step in the right direction, but continued vigilance is necessary to ensure that third-party payers do not use wellness reforms to undermine the aca's goals with respect to health care access and disease prevention. i also suggest that public health advocates should continue to seek the support of third-party payers in their efforts to transform our workplaces, communities, schools, and marketplaces to make them more conducive to healthy living. 18 lindsay f. wiley, shame, blame, and the emerging law of obesity control, 47 u.c. davis l. rev. 121 (2013) [hereinafter wiley, shame]. indiana health law review i. personal responsibility for wellness in the federal health law landscape after a hard fought political battle, followed by supreme court litigation that left its own marks, the united states health care system is in the midst of a challenging transformation. we are shifting toward a far more collective approach to health care financing, while maintaining the basic configuration of our fragmentary health care delivery and financing system. the aca is expanding medicaid eligibility beyond the specific categories covered under previous law.19 in states that choose to accept the expansion (the supreme court's ruling made it truly optional20), all individuals living below 138% of the federal poverty level are now eligible, including childless, non-disabled adults.21 the health insurance portability and affordability act of 1996 ("hipaa") and the aca sharply restrict the ability of private health insurance plans to manage and segment risk through individually-focused underwriting. 22 to make these reforms more feasible and palatable for insurers, the aca mandates the purchase of private insurance for virtually all individuals who can afford it and who are not otherwise covered.23 the threat of a tax penalty24 and the availability of financial assistance for lowerand middle-class individuals and families25 encourage healthy people to purchase insurance now, rather 1s patient protection and affordable care act, pub. l. no. 111-148, § 2001, 124 stat. 119-1025 (2010). 20 constance macintosh, the role of law in ameliorating global inequalities in indigenous peoples' health, 41 j.l. med. & ethics 77 (2013). 21 sidney d. watson, embracing justice roberts' 'new medicaid" 6 st. louis u. j. health l. & pol'y 247 (2013). 22 see infra part i.a.1. 23 26 u.s.c. § 5000a(a) (the minimum essential coverage requirement). 24 26 u.s.c. § 5000a(b) (the shared responsibility payment). 25 26 u.s.c. § 36b (premium assistance tax credits); 42 u.s.c. § 18071 (cost-sharing reduction payments). vol. 11:2642 2014 aca's personal responsibility for wellness reforms 643 than waiting to take advantage of the guaranteed issue26 and community rating27 protections. taken together, these reforms effectively subsidize intensive health care consumers at the expense of healthier, less intensive health care consumers, while also protecting those who are perceived as likely to become intensive health care consumers in the future.28 along with increased public responsibility for health care financing comes renewed interest in public responsibility for "upstream" prevention of disease and injury as a strategy for reducing health care costs and improving the public's health and wellbeing. justice scalia famously warned that if the government can force people to buy health insurance, there is nothing to stop it from forcing them to buy broccoli as well. 2 9 so far, no one has seriously proposed an "eat your vegetables" mandate, but state and local governments are pursuing a wide range of strategies to make healthy choices easier and unhealthy choices harder, including subsidization of fresh produce, taxation of harmful products, zoning and licensing rules aimed at shifting the balance between healthy and unhealthy retail food establishments, and rules governing portion sizes.30 the aca itself includes 26 42 u.s.c. § 300gg-1 (guaranteed issue and renewability requirements for health plans). 27 42 u.s.c. §§ 300gg, 300gg-4 (restricting discriminatory premium rates and prohibiting other forms of discrimination based on health status). 28 subsidy of the unhealthy by the healthy is a feature of every health care system in the world. the means by which that subsidy is achieved are simply more or less hidden. the aca makes subsidies more visible, but they were always there, including in the form of padded prices charged to patients with private insurance and out-ofpocket payers to help cover the costs of uncompensated care provided (often inefficiently through the emergency room) to the uninsured. 29 james b. stewart, how broccoli landed on supreme court menu, n.y. times (june 13, 2012), http://www.nytimes.com/2012/06/14/business/ how-broccoli-became-a-symbol-in-the-health-care-debate.html?-r=0, archivedathttp://perma.cc/v4qq-edy9. so see lindsay f. wiley, manel kappagoda & anne pearson, public health law. non-communicable disease prevention, in the oxford handbook of u.s. health law (glenn gohen et al. eds.) indiana health law review a federal excise tax on tanning bed services, 31 a calorie labeling mandate for restaurant menu items, 32 regulations to facilitate breastfeeding, 33 and grants to fund other community-level prevention strategies. 34 within the context of this broad movement toward greater collective responsibility for health, there is considerable push-back. "personal responsibility" for health (and financial security, education, and many other aspects of life) has long been a conservative mantra.35 it is also used quite cynically-and successfully-by industries that market harmful products (guns, unsafe vehicles, tobacco, alcohol, fast food, and sugary drinks) in their efforts to avoid regulation.36 more recently, it is being used by thirdparty payers to blunt the impact of health care reform. less well-known provisions of the aca promote personal responsibility for wellness through regulatory exceptions and grant programs aimed at employers, private health plans, and state medicaid programs. through these provisions, "the health reform law pays obeisance to the notion that individuals bear responsibility for their own health but can be guided through a system of rewards and penalties to make the 'right' choices." 37 (forthcoming 2014) (describing the public health law toolkit for influencing health behaviors through environmental changes). 31 26 u.s.c. § 5000b (10% excise tax on tanning bed services). 32 21 u.s.c. § 343(q)(5)(h) (requiring restaurants to disclose calorie counts on menus). 33 29 u.s.c. § 207(r)(1) (requiring employers to provide adequate break time and facilities for nursing mothers). 34 42 usc § 300u-13 (community transformation grants). 35 see lindsay f. wiley et al., who's your nanny? choice, paternalism and public health in the age of personal responsibility, 41 j.l. med. & ethics s88 (2013). 36 id. at s89. 37 janet l. dolgin & katherine r. dieterich, weighing status: obesity, class, and health reform, 89 or. l. rev. 1113, 1134 (2011). 644 vol. 11:2 2014 aca's personal responsibility for wellness reforms 645 a. personal responsibility for wellness: conditioning financial incentives on medical compliance, lifestyle compliance, and biometrics the aca personal responsibility for wellness provisions were adopted at a time of surging scientific and political interest in the use of financial incentives to encourage healthier behaviors. personal responsibility incentives can be aimed at influencing "medical compliance" behaviors, such as reporting on time for scheduled medical appointments, taking medications as prescribed, and submitting to recommended vaccinations and screening tests.38 they can also be aimed at influencing "lifestyle compliance"-including behaviors like tobacco use, diet, and exercise. more controversially, incentives can be tied to the achievement or maintenance of biometrics (such as weight, body mass index, blood pressure, cholesterol, or blood glucose) within specified ranges. this approach effectively treats an individual's health status as a proxy for behavior or lifestyle choices. 39 38 see soeren mattke et al., workplace wellness programs study: final report xiii (2013) [hereinafter rand report], available at http://www.rand.org/content/dam/rand/pubs/research_reports/rr200/ rr254/randrr254.pdf, archived at http://perma.cc/y6qm-t26e. 39 although healthier eating and physical activity are recommended to prevent and manage obesity, high blood pressure, high cholesterol, and high blood glucose, the characterization of these biometrics as the product of lifestyle choices alone is far from accurate. see, e.g., j.j. hottenga et. al., heritability and stability of resting blood pressure, 8 twin res. hum. genetics 499 (2005) (reviewing twin studies and finding that between 34% and 67% of variation in blood pressure from person to person is explained by genetic factors); cathy elks, variability in the heritability of body mass index: a systematic review and meta -regression, 14 obesity revs. 872 (2013) (reviewing twin studies finding between 47% and 90% of variation in adult body mass index from person to person is explained by genetic factors); daphna weissglas-volkov & pdivi pajukanta, genetic causes of high and low serum hdl-cholesterol, 51 j. lipid res. 2032 (2010) (noting estimates that between 40% and 60% of variation in hdl cholesterol from person to person is explained by genetic factors), available at http://www.jlr.org/content/51/8/2032; annemarie simonis-bik et al., heritability of hbalc and fasting blood glucose in different indiana health law review some experimental approaches have rewarded compliance with small, one-time incentives: a few dollars, a voucher or gift card, or participation in lotteries for the same. studies suggest that these approaches work best when targeted at compliance with a simple requirement (such as showing up for the third shot in a series of vaccinations, taking a dose of tuberculosis medication under observation, or reporting for a post-natal doctor's appointment), but are considerably less effective at inducing more complex forms of compliance (such as eating a healthy diet, engaging in physical activity on a regular basis, or quitting smoking).40 other experimental approaches have rewarded compliance with larger financial rewards that are doled out more gradually. but even long-term programs with incremental incentives have thus far been associated with only small and temporary effects on weight or smoking cessation.41 participants who lose weight tend to regain the weight (and then some).42 and former smokers who quit measurement settings, 11 twin res. hum. genetics 567 (2008) (twin study finding that 75% of variation in glycated hemoglobin from person to person is explained by genetic factors). 40 see rand report, supra note 38, at 76, 92; adam oliver & lawrence d. brown, politics of prevention: a consideration of user financial incentives to address health inequalities, 37 j. health pol. pol'y & l. 201 (2012). 41 see jill r. horwitz et al., wellness incentives in the workplace: cost savings through cost shifting to unhealthy workers, 32 health aff. 468, 471(2013) ("four comprehensive weight loss reviews show little significant loss-particularly over longer periods of time, such as twelve months. for example, a review of long-term, multicomponent weight management programs identified twelve trials, four of which included incentives. the review's conclusion: incentive-based interventions promoted weight loss, but participants tended to regain the weight."). 42 id. at 471 ("a meta-analysis of seven trials with follow-up periods of at least twelve months found that financial incentives were associated with a weighted mean loss of 0.88 pound at twelve months and 1.5 pounds at eighteen months, and a weighted mean gain of 2.42 pounds at thirty months, although none of the results were [statistically] significant."). 646 vol. 11:2 2014 aca's personal responsibility for wellness reforms 647 after receiving incentives are more likely to relapse than those who quit without incentives. 43 the terms on which health care coverage is provided are complex and multi-faceted, creating numerous opportunities for the application of small, one-time incentives as well as larger, long-term rewards aimed at medical and lifestyle compliance, as well as maintenance or achievement of particular biometrics. encouraged by federal regulatory exemptions, waivers, and funding, third-party payers are experimenting with the use of premiums, deductibles, copays, co-insurance, provider networks, and benefits to create incentives for various forms of compliance. in part ii, i will describe current federal programs in detail. b. types of health -care coverage and federal regulation to ensure access to appreciate how the aca personal responsibility for wellness provisions operate, one must understand the basics of how people get health-care coverage and how each type of coverage is regulated at the federal level to promote more universal health-care access. before i turn to detailed description of the aca's personal responsibility for wellness provisions, i need to describe the general types of healthcare coverage affected by these provisions-private group health plans, private individual-market health insurance, and medicaid-and the basic contours of access-focused regulation with respect to each. this section provides general background that readers familiar with hipaa's portability provisions, the aca's private insurance reforms, and federal medicaid law may wish to skip. 43 id. at 471 ("in one study, all participants received $45 for each interview and blood draw (up to a total of $180), and incentive group members received $750 for smoking cessation, confirmed by cotinine testing-that is, testing for a chemical found in cigarette smoke. after six months, 9.4% of the incentive group remained non-smoking, compared to 3.6% of the control group. however, relapse rates six months after the incentives ended were significantly higher for the incentive group."). indiana health law review 1. private health insurance the majority of americans under age sixty-five are covered by private health plans.44 federal (and state) regulation of private health care coverage is organized around the three main segments of the private marketlarge-group, small-group and individual/non-group plansbased on the unique market forces affecting each. most private health insurance is offered as a benefit of employment. 45 most of these plans cover large groups, allowing them to reduce actuarial risk by pooling large numbers of employees, which makes medical losses more predictable. 46 small employers are less likely to offer health insurance, though many do in spite of the higher per-worker costs. 47 these small-group plans are more expensive because smaller groups have less bargaining power, higher per-worker overhead costs, and smaller risk pools. 4 8 both large-group and small-group plans benefit from the "healthy worker" effect (for a variety of reasons, people who work generally have lower health-care costs than those who do not).49 individual, or "non-group" health plans that are not tied to employment make up a very small segment of the market.50 the individual market is an important one, however, because it is the only option for individuals who do not have insurance through their employment and do not 44 health insurance coverage for adults 19-64, henry j. kaiser found., http://kff.org/other/state-indicator/adults-19-64/ (last visited apr. 24, 2014). 45 id. 46 consumer guide to group health insurance, nat'l ass'n of health underwriters, http://www.nahu.org/consumer/ groupinsurance.cfm (last visited apr. 24, 2014) [hereinafter cgghi], archived at http://perma.cc/3c8l-xk2b. 47 see paul b ginsburg et al., tracking small-firm coverage, 19891996, 17 health aff. 167 (1998). 48 cgghi, supra note 46. 4 see, e.g., a.j. mcmichael, standardized mortality ratios and the "healthy worker effect":' scratching beneath the surface, 18 j. occupational med. 165 (1976). 50 deloitte, the impact of health reform on the on the individual insurance market: a strategic assessment (2011). 648 vol. 11:2 2014 aca's personal responsibility for wellness reforms 649 qualify for public programs like medicare and medicaid. 51 it is also a particularly problematic market because less healthy individuals (who anticipate that they will need to consume a lot of health care) tend to be overrepresented in the individual market and individual market insurers are unable to spread actuarial risk across the healthier, larger pools that employment-based plans enjoy.52 unlike home, auto, or life insurers, health plans are prohibited from engaging in the most basic forms of riskbased underwriting.53 the main tools employed by insurers to differentiate and manage risks (denying coverage to highrisk applicants, charging them higher premiums, and imposing less favorable cost-sharing or coverage exclusions on them) are now prohibited or greatly restricted by federal law. the aca's "guaranteed issue" provision requires that private health insurers offer coverage to all comers, regardless of health status or related factors. 54 "community rating" provisions in the aca sharply limit insurers' ability to manage financial risk by charging higher rates to individuals who are likely to have greater health-care needs.@5 and bans on exclusions for treatment of preexisting conditions mean that insurers must cover conditions that are present at the time of enrollment even if they are certain to result in extensive payment of benefits by the insurer.5 6 for large employment-based group plans, larger risk pools and the healthy worker phenomenon make guaranteed issue and community rating quite feasible. indeed, most group plans already followed these practices before they were required to do so by the health insurance 51 id. 5 2 id. 53 wendy k. mariner, health reform: what's insurance got to do with it. 36 am. j.l. & med. 436 (2010). 54 see 42 u.s.c. § 300gg-4(a) (guaranteed issue and renewability). 55 42 u.s.c. § 300gg-4(b) (prohibiting discriminatory premium rates). 56 42 u.s.c. § 300gg-3 (prohibiting pre-existing conditions exclusionary clauses and other forms of discrimination based on health status). indiana health law review portability and accountability act of 1996 ("hipaa").57 but the aca's extension of these regulations to the individual market in 2014 and its expanded ban on pre-existing conditions exclusions for all plans pose new challenges. particularly in light of their reduced ability to manage risk using the tools of traditional insurance, private employers (whether large or small) and private insurers are highly motivated to reduce health-care costs through other means. on average, employers who offer health insurance coverage as a benefit of employment pay about $11,000 per year for family coverage and $4500 per year for single coverage.5 8 insurers are under pressure from consumers to keep premium increases to a minimum even as health-care costs continue to rise at a rate that far outstrips regular inflation. premium increases in the small-group and individual markets are monitored by federal and state regulators.59 large hikes are also routinely reported on by the media-generating bad press for health plans and "obamacare" reforms alike. 2. public programs nearly one-quarter of the u.s. population is covered by medicaid or the children's health insurance program ("chip"), a federally block-granted adjunct to medicaid. 60 57 see health insurance portability and accountability act, pub. l. 104-191, 110 stat. 1936 (1996). 58 see kaiser family found. & health research & educ. trust, employer health benefits: annual survey 64 (2011), http://kaiserfamilyfoundation.files.wordpress.com/2013/04/8225.pdf. 59 see, e.g., 42 usc § 300gg-94 (2014) (providing for premium rate reviews); national conference of state legislatures, state approval of health insurance rate increases, http://www.ncsl.org/researchlhealth/ health-insurance-rate-approval-disapproval.aspx (last updated february 2014) (surveying state laws regarding rate increase review and approval), archived at http://perma.cc/4fby-cpts?type=image. 60 medicaid enrollment as a percent of total population, 2010, henry j. kaiser family found., http://kff.org/medicaid/stateindicator/medicaid-enrollment-as-a-of-pop/ (indicating medicaid enrollment as of 2010 as 21% of the total u.s. population); diane rowland et al., medicaid and chip payment and access comm'n, 650 vol. 11:2 2014 aca's personal responsibility for wellness reforms 651 unlike medicare (a program for the elderly and disabled that is entirely federally run),61 medicaid is funded and administered jointly by the federal government and the states. as such, it is governed by relatively broad federal guidelines that give states considerable leeway to determine the exact contours of eligibility and benefits. 62 even greater flexibility is afforded through a waiver process whereby a state may petition the centers for medicare and medicaid services to waive particular regulations as part of a research or demonstration project. section 1115 of the social security act gives the hhs secretary authority to waive regulations with respect to approved experimental, pilot, or demonstration projects.63 with a section 1115 waiver, a state may develop and implement new approaches to coverage that would otherwise by prohibited under federal law. these demonstration projects are typically approved for a five-year term, renewable for an additional three years. demonstration projects must be budgetneutral with regard to federal expenditures,6 4 but federal grant programs occasionally make additional funds available to test new approaches. the states have an enormous interest in controlling health-care costs associated with their medicaid programs. medicaid spending accounted for nearly one-quarter of all report to the congress on medicaid and chip 5 (2013), available at https://docs.google.com/viewer?a-v&pid=sites&srcid=bwfjcgfjlmdvdn xtywnwywn8z3g6nwe3mtm2nwu4njhhndvmyq (providing enrollment numbers for 2013 that equate to 23% of the total u.s. population). 61 medicare has not been the focus of aca personal responsibility for wellness provisions and thus is not discussed further in this article. 62 nicole huberfeld, federalizing medicaid, 14 u. pa. j. const. l. 431, 447-48 (2011) 63 id. 64 section 1115 demonstrations, medicaid.gov, http://www.medicaid. gov/medicaid-chip-program-information/by-topics/waivers/1115/section1115-demonstrations.html (last visited apr. 24, 2014), archived at http://perma.cc/9nv4-c8u6. indiana health law review state expenditures in 2013.65 smoking among medicaid recipients is 53% more prevalent than among the population as a whole, 66 and annual medical costs for smokers are significantly higher than those for nonsmokers.67 although information about diabetes prevalence among the medicaid population is not available, 68 commentators have suggested that "[t]he high prevalence of diabetes among minority populations coupled with the high percentage of minority medicaid beneficiaries suggests that a disproportionate number of medicaid beneficiaries suffer from diabetes."69 and diabetes is a very expensive disease to manage.70 given what is known about the strong links between many health problems and poverty,'7 1 it seems 65 nat'l ass'n of state budget officers, state expenditure report 2 (2013), available at http://www.nasbo.org/sites/default/ files/state%20expenditure%2oreport%20%28fiscal%202011-2013&20 data%29.pdf, archivedathttp://perma.cc/e4mw-jpdh. 66 brian s. armour et al., state-level medicaid expenditures attributable to smoking, 6 preventing chronic disease a84, a84 (2009), available at http://www.cdc.gov/pcdlissues/2009/jul/08_0153.htm, archived at http://perma.cc/9482-b2eb. 67 maggie fox, smoking employees cost $6,000 a year more, study finds, nbc news (june 3, 2013, 6:55 pm), http://www.nbcnews.com/health/ smoking-employees-cost-6-000-year-more-study-finds-6c10182631, archived athttp://perma.ce/a7sa-7gux?type-image. 68 see, e.g., diabetes medicare beneficiaries (percent), health indicators warehouse, http://healthindicators.gov/indicators/ diabetes-medicare-beneficiaries-percent_294/profile/classicdata (last visited apr. 24, 2014) (reporting that more than one-quarter of medicare beneficiaries have diabetes, but lacking similar information regarding medicaid beneficiaries), archived at http://perma.cc/4eh6-tybp. 69 health strategy consultancy & duke univ. fuqua sch. of bus., medicaid cost containment and potential effects on diabetic beneficiaries 1, 6 (2003), available at http://www.avalerehealth.net/research/docs/hscdiabeteswhitepape r_20031021.pdf. 70 xiaohui zhuo et al., lifetime direct medical costs of treating type 2 diabetes and diabetic complications, 45 am. j. preventative med. 253 (reporting that diabetics face medication costs up to $600 annually, in addition to approximately $500 in physicians visits, and $100-$300 in self-testing devices), available at http://www.ajpmonline. org/article/so749-3797(13)00338-3/fulltext. 71 alyssa brown, with poverty comes depression, more than other ilnesses, gallup (oct. 30, 2012), http://www.gallup.com/pol/158417/ 652 vol. 11:2 2014 aca's personal responsibility for wellness reforms 653 likely that the medicaid population is generally sicker than the non-medicaid population. ii. the aca's personal responsibility for wellness provisions the aca promotes personal responsibility for wellness through five main provisions targeting each of the types of health-care coverage described above. first, the statute mandated that the secretaries of health and human services, labor, and treasury report to congress on the effectiveness and impact of the workplace wellness programs that are becoming a common feature of largegroup health plans. second, although the aca generally prohibits private health plans from discriminating on the basis of health factors, a "wellness program" exception allows group health plans to adopt incentives and penalties tied to the terms of coverage as part of a program of health promotion and disease prevention. third, the statute directed dhhs to establish a demonstration project whereby individual-market health plans are permitted to adopt wellness programs. fourth, the aca authorized a program to subsidize the creation of new workplace wellness programs by small businesses. fifth, the aca mandated a grant program for state medicaid programs experimenting with the use of incentives aimed at chronic disease prevention. in this part, i will examine agency implementation with regard to each of these provisions. although the statute itself provides fairly detailed parameters for each of these provisions, federal agencies retain significant flexibility to resolve and clarify statutory ambiguities. as described below, agencies appear to be resolving statutory ambiguities in ways that minimize the poverty-comes-depression-illness.aspx?utm source=alert&utmmedium= email&utmcampaign=syndication&utmcontent=morelink&utmterm=ali %20gallup%20headlines (finding that more than 30% of people living in poverty have been diagnosed with depression at some point, compared to only 16% of people not living in poverty), archived at http://perma.cc/3r79sxpf. indiana health law review impact of the personal responsibility for wellness provisions while reinforcing the aca's broader goals of health care access and disease prevention. a. the 2013 rand report on workplace wellness programs in may 2013 (possibly timed to coincide with the promulgation of the wellness program rule discussed below), the non-profit rand corporation released a study on workplace wellness programs sponsored by dhhs and the department of labor.72 the study satisfied an aca mandate that the departments report to congress on the effectiveness of wellness programs and their impact on access to care and affordability of coverage.7 3 unsurprisingly, the findings of the rand study did not fully support the hyperbolic 2010 congressional testimony of safeway executives and others about the benefits of workplace wellness programs. 74 as described in detail below, the study found that while workplace wellness programs are quite popular with employers, their impact on health-care costs and health outcomes is limited. the rand survey data and qualitative analysis of five anonymous employer case studies also provide a useful overview of how typical workplace wellness programs operate. 72 rand report, supra note 38. 73 see 42 u.s.c. § 2801-1 (2014). the wellness program exception to non-discrimination provisions in the aca and the health insurance portability and affordability act of 1996 is implemented jointly by dhhs and the department of labor. 74 see david s. hilzenrath, misleading claims about safeway wellness incentives shape health-care bill, wash. post (jan. 17, 2010), http://www.washingtonpost.com/wp-dyn/content/article/ 2 010/01/ 15/ar2010011503319.html ("in a legislative debate filled with misconceptions, few rival the myth about safeway, which has become the poster company for a provision that big employers and insurers covet. the supermarket chain's story shows how the untested claims of interest groups can take on a life of their own and shape national policy."), archived at http://perma.cc/3fk8-m5mf. vol. 11:2654 2014 aca's personal responsibility for wellness reforms 655 1. the prevalence and design of workplace wellness programs approximately half of u.s. employers with fifty or more employees report that they offer wellness programs.75 these programs cover nearly 80% of employees working for firms with fifty or more employees. 76 among employers who report that they do not currently offer a wellness program, more than a quarter express that they are considering offering one in the near future.77 employers typically combine multiple program components with various features. how wellness programs are regulated depends heavily upon the classification of each program component based on its design features. for this reason, it is worth parsing the rand report survey data regarding the prevalence of various design features in some detail. some workplace wellness program components, which i will refer to as "employer responsibility" programs, are aimed at making the worksite a healthier environment in ways that "make the healthy choice the easy choice"7 8 for employees. for example, half of all employers with fifty or more employees report that they offer on-site flu vaccination services. 79 forty percent say they offer free or subsidized gym memberships or on-site facilities.80 and some employers have taken steps to ensure the availability of healthy food and beverage options in their cafeterias, vending machines, or at meetings.8 ' for example, one of the five anonymous case study employers described in the rand study (rand employer b) reports that it coordinates with a local farmer to sell fresh produce to 75 see rand report, supra note 38, at 18. as noted in the introduction, the proportion is significantly higher among employers with 1000 or more employees. 76 id. at 19. 77 id. at 21. 78 id. 79 id. at 23. 80 id. 81 id. at 22. indiana health law review employees once per week and offers a healthy, low-cost lunch special in the cafeteria. 82 most wellness programs, however, include one or more components that place the onus on individual employees to change their behaviors. 83 i will refer to these generally as "personal responsibility" programs, and will further categorize them into distinct sub-types (see table 1). these programs typically employ financial rewards or penalties84 8 2 id. 83 id. at 25 (reporting that 72% of employer wellness programs include a combination of screening and interventions focused on behavior change). 84 in general, i treat rewards and penalties as interchangeable. see families usa, wellness programs: evaluating the promises and pitfalls 3-4 (2012) ("the difference between a reward and a penalty in a wellness program can be illusory, because a wellness program reward can result in the exact same negative financial effect on workers as a penalty. to understand this, let's imagine a scenario: an employer decides to offer its workers a wellness program in conjunction with health coverage and wants to vary workers' premiums based on whether they participate in a health assessment and five health coaching classes. . .. the employer can achieve this by implementing either a reward or a penalty program. option 1: . . . the employer sets all employees' premium contributions at $200 a month. if workers do not complete the wellness program, they have to pay a premium surcharge of $50 a month. . . . option 2: the employer sets all workers' premium contributions at $250 a month, and workers who participate in the wellness program receive a $50 per month discount on their premiums as a reward. ... in both option 1 and option 2, workers who cannot participate in the wellness program end up paying $250 a month in premiums, which is $50 more than the workers who do participate."), available at http://familiesusa.org/sites/default/files/productdocuments/ wellness-programs.pdf, archived at http://perma.cc/7lss-phwk. the 2013 rule explicitly treats penalties and rewards as interchangeable. see 29 c.f.r. § 2990.702(f)(1)(i) ("except where expressly provided otherwise, references in this section to an individual obtaining a reward include both obtaining a reward (such as a discount or rebate of a premium or contribution, a waiver of all or part of a cost-sharing mechanism, an additional benefit, or any financial or other incentive) and avoiding a penalty (such as the absence of a premium surcharge or other financial or nonfinancial disincentive). references in this section to a plan providing a reward include both providing a reward (such as a discount or rebate of a premium or contribution, a waiver of all or part of a cost-sharing mechanism, an additional benefit, or any financial or other incentive) and imposing a penalty (such as a surcharge or other vol. 11:2656 2014 aca's personal responsibility for wellness reforms 657 to prompt individual compliance with desired behaviors.85 they generally begin with a screening component to identify at-risk individuals (often with a financial reward to encourage participation in the screening process). many employers couple that screening component with an intervention component aimed at urging individuals to change their behavior. in many cases, the employer offers a financial award to those who participate in the intervention component, without regard to results. in some cases, the employer offers a financial reward conditioned upon attainment of particular results (such as a 5% weight loss). other programs offer a financial award tied directly to the maintenance or achievement of biomarkers within a certain range (such as blood cholesterol levels or a body mass index within a defined range) or to the absence of certain risk factors (such as tobacco use). personal responsibility programs might include some aspects that make behavior change easier, for example by hosting health screenings or behavior change programming on-site for employees' convenience, but the primary focus is on encouraging employees (and in some cases their dependents)86 to take responsibility for their own health. individuals who currently have or are at increased risk for disease are identified through screening. about 80% of employers that offer wellness programs include some kind financial or nonfinancial disincentive)."). the 2006 rule also treated rewards and penalties as interchangeable. 29 c.f.r. §2590.702(f)(2)(i) (superseded) ("a reward can be in the form of a discount or rebate of a premium or contribution, a waiver of premium or contribution, a waiver of all or part of a cost-sharing mechanism (such as deductibles, copayments, or coinsurance), the absence of a surcharge, or the value of a benefit that would otherwise not be provided under the plan.") (emphasis added). 85 of the 51% of employers in the rand survey that have instituted workplace wellness programs, nearly 70% have adopted some kind of financial incentive. id. at 70. 86 the rand report did not focus on this issue, but annual surveys of employers with 1000 or more employees conducted by towers watson indicate that about 40% of very large employers extended financial incentives for wellness to covered spouses in 2014, up from 34% in 2013. see towers watson survey, supra note 10, at 23. indiana health law review of screening component. 87 of those, about 38% conduct their screening programs solely through health risk assessments ("hras"),88 which typically take the form of a questionnaire to collect self-reported information about risk factors and behaviors, including nutrition, physical activity, smoking, weight, blood pressure, and cholesterol.8 9 more than two-thirds of employers that offer wellness programs use clinical tests that collect biometric data, such as height, weight, blood pressure, blood glucose, and cholesterol, either alone or in combination with hras.90 these clinical screenings can be conducted on-site or off-site. some employers conduct screenings for employees only, while others also screen family members covered by the employerbased health plan. some incentive-based wellness programs offer rewards for completion of screening assessments or tests, with no further action required based on the results. the health plan might offer incentives like cash payments or prizes unrelated to the terms of health-plan coverage. for example, rand employer c reports that it offers $50 for completion of an online health assessment and $20 for completion of biometric screening.9' or they might tie the financial incentive directly to the terms of health-plan coverage. 92 for example, rand employer d reports that it offers up to a $2600 premium differential to employees who complete health screenings, regardless of the results. 93 rand employer b reports that as part of a one-time pilot program, it offered a $15 reduction in co-payments for the 87 id. at 27. 8s id. 89 id. at 21. 90 id. at 27. 91 id. at 71. forty-seven percent of employers with wellness programs offer merchandise or gift cards, and 21% offer cash. id. at 72. 92 thirty-eight percent of employers who offer wellness program incentives use discounts or surcharges to alter the cost of health insurance premiums, while about 3% alter the terms of cost-sharing arrangements (such as co-pays) as an incentive. id. at 72. 93 id. at 71. vol. 11:2658 2014 aca's personal responsibility for wellness reforms 659 year as a reward to employees who completed an on-site health screening.94 prior to the implementation of non-discrimination provisions in hipaa (for group plans) and the aca (for all plans, including insurers in the individual market), these same kinds of screenings were typically conducted by health insurers as part of the application and underwriting process.95 in contrast, workplace wellness screenings may not be used to deny coverage to particular employees or their dependents. 96 screening test results may, however, be used by employers and group health plans to impose premium discounts or surcharges based on test results or to direct particular individuals to intervention programs. even for programs that do not include an interventional component, the hope is that giving individuals information about their risk factors might prompt them to alter their behavior. personal responsibility interventions may be focused on medical compliance (more than half of employers that have established wellness programs include disease management interventions aimed at promoting adherence to prescribed treatment regimens97) or lifestyle compliance (about 77% of employers offering a wellness program report that they offer lifestyle interventions98). among employers offering interventions aimed at promoting lifestyle compliance, nearly 80% offer nutrition or weight-loss programs, including on-site weight watcherstm group meetings, weight-loss competitions, or individualized counseling provided by outside vendors. 99 about the same proportion offer smoking-cessation programs of a similar nature, and 94 id. 95 id. 96 as described in part ii.b.1, infra, hipaa prohibited group health plans from discriminating on the basis of health status for the purposes of eligibility. 97 id. at 22. 98 id. at 21. 99 id. indiana health law review about half offer alcohol/drug abuse programs and stress management programs. 00 employer survey results indicate that about 24% of workplace smoking-cessation programs, 25% of weightmanagement programs, and 28% of fitness programs offer financial rewards for participation.101 apparently, many of these participation-only incentive programs are what i will refer to as "targeted" (in that they are offered to particular individuals based on risk factors or biometric markers identified via screening), while others are presumably offered to all individuals without regard to risk factors or biometric markers.102 for example, an employer might offer an incentive to any individual who attends an on-site monthly seminar providing nutritional education or a weekly on-site exercise program. or the program (and associated incentive) could be offered only to individuals who are identified as having high blood pressure or being overweight. a smaller-but growing-percentage of programs offer incentives dependent upon particular risk factors or biometric values.103 some programs offer what i will refer to as "status-dependent" financial incentives. these programs offer rewards to (or impose penalties on) individuals identified through screening as falling within 100 id. 101 id. at 90. 102 the rand survey does not distinguish between targeted and non-targeted participation-only incentives, but survey data regarding the percentage of eligible employees who take advantage of participation-only programs (with eligibility apparently based on health status) indicate that many programs are targeted. see id. at 38. 103 as discussed in the introduction, statusand result-based incentives are expanding rapidly among employers with 1000 or more employees. see towers watson survey, supra note 10, at 22-23 (indicating that among employers with 1000 or more employees 42% had adopted incentives tied directly to smoking status as of 2014 with an additional 16% planning to do so in 2015 while 22% used incentives tied to biometrics like weight and cholesterol in 2014 with an additional 24% reporting that they planned to do so in 2015). these data did not distinguish among status-dependent, results-dependent, and two-tier programs but probably encompass all three. vol. 11:2660 2014 aca's personal responsibility for wellness reforms 661 particular parameters. for example, rand employer d reports an annual premium differential of up to $754 (on top of premium discounts available for mere completion of screenings) based solely on biometric readings and smoking status as assessed during annual onsite clinical screenings. 104 similarly, rand employer b reports that smokers are restricted to a lower-value health plan coverage option. 105 in other cases, a reward is not offered immediately upon the determination that an individual's biometrics are within a particular range, but is instead dependent upon results achieved through participation in an interventional program (i will call these "resultsdependent"). the rand survey indicates that 19% of employers that offer smoking-cessation programs offer financial incentives for actual cessation (which can be measured by self-report or through clinical tests), while 6% of employers offering fitness programs and 3% offering weight-management programs offer incentives for attainment of predetermined weight loss or fitness goals.106 finally, some employers use a "two-tier" approach. for example, rand employer a reports that it imposes a $50 annual insurance premium surcharge for smokers who decline to participate in a smoking-cessation program or 104 id. at 71, 84. employer d reports that it verifies smoking status through blood tests. id. at 70. cotinine testing detects tobacco use by measuring a metabolite of nicotine. the rand study indicates that among employers who report that they have adopted clinical screenings (as opposed to self-administered questionnaires) as part of their wellness programs, 12% screen for tobacco use. id. at 28. it is unclear, however, whether this "clinical screening" for tobacco use involves a cotinine test or simply amounts to a health care provider asking the patient about tobacco use. some employers require prospective employees to submit to a cotinine test as a condition of employment. see a.g. sulzberger, hospital shifts smoking bans to smoker ban, n.y. times (feb. 10, 2011), http://www.nytimes.com/2011/02/11/us/ 11smoking.html?pagewanted=all, archived at http://perma.cc/ur6e5nah. 105 id. there is no reference in the report to whether smokers are permitted to enroll in the higher-value coverage option if they also participate in a cessation program, so i will assume that they are not. 106 id. at 90. indiana health law review make use of smoking-cessation products provided by the employer. rand employer c takes a slightly different approach, imposing a surcharge of up to $600 on smokers who report that they do not intend to quit smoking. setting aside the question of whether the surcharge should be characterized as a penalty or the absence of it as a reward, the program can be understood as having two tiers. first, smokers are separated from non-smokers,107 with nonsmokers automatically avoiding the surcharge (or obtaining the "reward"). second, individuals who do smoke are given the opportunity to do something else to avoid the penalty, whether that "something else" is simply certifying that they intend to quit or that they are consuming cessation products offered by the employer, or actually participating in a cessation-counseling program. if they do this "something else," they too will avoid the surcharge. in table 1, i offer a summary of the various types of wellness programs described in the rand study and the labels i have assigned to each. table 1: wellness program typology based on descriptions in the rand report employer responsibility programs non-targeted participation-only incentive the employer offers services or alters the worksite for the benefit of all employees. e.g., an employer offers healthy, low-cost meal options in the cafeteria, provides on-site gym facilities, or hosts on-site flu vaccination clinics. the employer offers incentives to all individuals, without regard to health status or risk factors, for 107 the rand study reports that employers a and c used selfreport to identify smokers (meaning the individuals were asked to describe their tobacco use). see rand report, supra note 38, at 73. vol. 11:2662 2014 aca's personal responsibility for wellness reforms 663 programs targeted participation-only incentive programs participation in intervention programs, without regard to results. e.g., all employees are offered a financial incentive for participating in a health education seminar about healthy eating. the employer designates particular individuals as eligible for participation in intervention programs based on their health status or risk factors and offers those employees rewards for participation, without regard to results. e.g., smokers are offered financial incentives for participating in a cessation program. status-dependent . the employer automatically incentive applies rewards or penalties based programs solely on individuals' health status or risk factors. e.g., smokers must pay a premium surcharge; employees with a body mass index below 26 are offered a premium discount. results-dependent the employer offers rewards incentive conditioned on the achievement of programs particular results through intervention programs (or independently). e.g., participants in a smoking cessation program are offered a reduction in their co-payment rate for remaining tobacco-free for six months; participants in a weight loss program are offered a premium discount for losing 5% of their body weight. i indiana health law review two-tier programs the employer divides individuals into two groups based on health status or risk factors. individuals in the "healthy" group are automatically given a reward. those in the "unhealthy" group are offered the same reward conditioned upon participation in an intervention program or achievement of particular results. e.g., smokers must pay a premium surcharge unless they attend a weekly smoking cessation program; non-smokers automatically avoid the surcharge. the rand report notes that the use and magnitude of financial incentives for wellness is likely to increase over time. nearly 90% of employers with 200 or more employees report that they plan to add or strengthen financial incentive programs. 0 8 a 2014 survey of employers with 1000 or more employees found that "the use of incentives . . . continues to grow significantly-with more focus on results than mere participation." 109 in spite of the popularity of incentives among employers, the rand study reports that "wellness program managers [have] mixed feelings about the use of incentives to encourage healthy behaviors," citing interviews conducted with wellness program representatives suggesting that there is a "struggle in the wellness field in general" over the use of financial incentives, as opposed to purely intrinsic, health-focused motivation.110 108 id. at 88-89. 109 see towers watson survey, supra note 10, at 22. 110 id. at 82. __________________________________________i vol. 11:2684 2014 aca's personal responsibility for wellness reforms 665 2. the impact of workplace wellness programs evaluation of the impact of these programs is limited. only about half of employers who have wellness programs report that they have evaluated them.11 ' the rand study's assessment of impact was limited to employer surveys regarding levels of participation in various components, supplemented by a small number of case studies of individual employers for which more detailed data was available. the results indicate that employee participation in wellness programs is not widespread. where screening components are offered, about half of employees participate in them.112 participation in intervention components is significantly lower. employers report that only 11% of eligible employees (with eligibility typically based on risk assessment results via a targeted approach) participated in a weight-loss program while only 7% of employees who smoke participated in a smoking-cessation program within the last twelve months.113 the rand study also examined more detailed data collected from a very small number of employers by the care continuum alliance ("cca"), an industry trade group that represents the interests of wellness program vendors and other groups interested in disease management. the cca data from one large employer suggests that participation in an exercise program is associated with 0.15 additional days per week during which participants exercise for twenty or more minutes, when compared to nonparticipants, with diminishing effects in subsequent years.114 similar data, also from a single employer, suggests that smoking rates are 30% lower among participants in a smoking-cessation program than among non-participants.115 cca data from four employers suggests that participation in a weight-loss, nutrition, or 111 id. at 53. 112 id. at 36. 113 id. at 38. 114 id. at 44. 115 id. at 45. indiana health law review exercise program is associated with a body mass index reduction of about 0.15 during the year of participation and additional, but diminishing reductions in subsequent years. overall, the average three-year reduction in body mass index associated with participation corresponds to a weight loss of about one pound.116 cca data from four employers do not indicate a statistically significant reduction in cholesterol. 117 the data were insufficient to show a statistically significant reduction in health care costs. the rand report notes, however, that other studies have demonstrated statistically significant health care cost reductions. for example, a widely reported 2010 metaanalysis suggested that the average return on each dollar invested in workplace wellness programs was about $3 in terms of reduction in health care costs and absenteeism.118 b. the group health plan wellness program exception as described above, some workplace wellness programs take an approach that emphasizes employer responsibility for creating a healthier work environment, while others adopt a personal responsibility approach. employer responsibility programs have the potential to improve the health of employees without penalizing those who are perceived as unhealthy. on the other hand, personal responsibility programs-especially those that make premium discounts, surcharges, or cost-sharing reductions dependent upon the absence of particular risk factors (like tobacco use) or the maintenance or attainment of "healthy" biometric values (like a body mass index or cholesterol level in a particular range), raise the possibility of bringing prohibited health-status underwriting "in through the back 116 the results were reported in terms of average change in body mass index, corresponding to weight loss of 0.9 pounds for an average woman of 165 pounds and 5'4" or about one pound in the average man of 195 pounds and 5'9". id. at 47. 117 id. at 51. 118 id. at 62 (citing katherine baicker et al., workplace welness programs can generate savings, 29 health aff. 304, 304-11 (2010)). 666 vol. 11:2 2014 aca's personal responsibility for wellness reforms 667 door."119 wellness programs that alter the terms of coverage based on "health status-related factors" (including smoking status, weight, blood pressure, cholesterol, and other medical history) are legally permissible for group health plans only because of an exception to the general rule prohibiting health plans from discriminating on the basis of these factors. 120 as described below, this exception originated in 1996 with hipaa121 and was fleshed out in regulations promulgated in 2006.122 in 2010, congress 119 timothy jost, implementing health reform: wellness programs and medicaid faqs, health affairs blog (nov. 21, 2012, 4:45 pm), http://healthaffairs.org/blog/2012/11/21/ implementing-health-reform-wellness-programs-and-medicaid-faq, archived at http://perma.cc/hv6d-8dle. 120 see 29 u.s.c. § 1182(b)(1) (2014) ("a group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, may not require any individual (as a condition of enrollment or continued enrollment under the plan) to pay a premium or contribution which is greater than such premium or contribution for a similarly situated individual enrolled in the plan on the basis of any health status-related factor in relation to the individual or to an individual enrolled under the plan as a dependent of the individual."); 42 u.s.c. § 300gg-4(b)(1) (applying the same prohibition to "a health insurance issuer offering group or individual health insurance coverage") (emphasis added). note that although smoking status meets the statutory definition for a health status-related factor, the aca allows insurers to vary premium rates by a 1.5 to 1 ratio based on smoking status, in a provision independent from the wellness program exception. see 42 u.s.c. § 300gg(a)(1)(a)(iv). this provision is relevant to interpretation of the 2013 wellness program rule and may help explain why smoking cessation incentives appear to be treated differently from other kinds of statusor results-based incentives under the examples set forth in the rule, as described below. 121 see 29 u.s.c. § 1182(b)(2)(b) (2014) (specifying that the prohibition of discrimination on the basis of health status-related factors shall not be construed "to.prevent a group health plan, and a health insurance issuer offering group health insurance coverage, from establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention."). 122 see nondiscrimination and wellness programs in health coverage in the group market; final rules, 71 fed. reg. 75,014, 75,017-19 (dec. 13, 2006) (codified at 26 c.f.r. pt. 54, 29 c.f.r. pt. indiana health law review imported the wellness program exception from hipaa into the aca.123 the aca also incorporates additional language regarding wellness programs from the 2006 rule. 124 regulations interpreting the aca provisions, released in 2013,125 indicate that dhhs is now taking a more skeptical stance toward personal responsibility incentives. compared to the 2006 rule, which it supersedes, the 2013 rule resolves statutory ambiguity in favor of subjecting a wider range of programs to more stringent requirements and is thus more likely to ensure that wellness programs are not used as a subterfuge for prohibited health-factor discrimination. 126 2590, and 45 c.f.r. pt. 146), available at http://www.dol.gov/ebsalregs/fedreg/final/2006009557.pdf, archived at http://perma.cclm7gb-ydet. although the federal register indicated that the provisions relevant to wellness programs would be codified at 45 c.f.r. § 146.121(0, in fact the relevant provisions were codified at 29 c.f. r. 2990.702(f) (2007) (superseded). as described below, these provisions were later superseded by the 2013 rule, which is codified at 29 c.f.r. 2990.702(f) (2014). 123 see 42 u.s.c. § 300gg-4(b)(2)(b) (2014) (specifying that the prohibition of discrimination on the basis of health status-related factors shall not be construed "to prevent a group health plan, and a health insurance issuer offering group health insurance coverage, from establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention."). 124 see 42 u.s.c. § 300gg-4(j)(1)(b) (2014) (adopting language almost identical to that found in 29 c.f.r. 2990.702(f) (2007) (superseded)); 42 u.s.c. § 300gg-4(j)(2) (adopting language almost identical to that found in from 29 c.f.r. 2990.702(f)(1) (2007) (superseded)); 42 u.s.c. § 300gg-4(j)(3) (2014) (adopting language very similar to that found in 29 c.f.r. 2990.702(0(2) (2007) (superseded) but with the important addition of language indicating that the requirements set forth in the statute are not exhaustive, as described below). 125 see incentives for nondiscriminatory wellness programs in group health plans; final rule, 78 fed. reg. 33158 (jun. 3, 2013) (codified at 26 c.f.r. pt. 54, 29 c.f.r. pt. 2990, and 45 c.f.r. pt. 146, 147) available at http://www.gpo.gov/fdsys/pkg/fr-2013-06-03/pdfl201312916.pdf. 126 the 2006 rule, the aca, and the 2013 rule all prohibit the use of wellness programs as a subterfuge for discrimination on the basis of health status-related factors. see 29 c.f.r. § 2990.702(f)(2)(ii) (2007) (superseded) 668 vol. 11:2 2014 aca's personal responsiblity for wellness reforms 669 1. the wellness program exception in hipaa hipaa prohibits group plans from discriminating based on health factors for purposes of eligibility or setting premiums or contributions. 127 "health factors" are listed in hipaa as "health status; medical condition, including both physical and mental illnesses; claims experience; receipt of health care; medical history; genetic information; evidence of insurability; and disability."128 plans are prohibited from imposing differential rates for particular individuals based on any of these factors. the statute includes a vaguely defined exception to the general non-discrimination rule that allows plans to "establish premium discounts or rebates or modify otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention."129 in 2006, the departments of health and human services, treasury, and laborl 30 jointly issued final regulations delineating the parameters of this exception.131 (stating that programs that condition a reward on satisfaction of health status-related standard "must be reasonably designed to promote health or prevent disease" and specifying that this standard is satisfied if a program "has a reasonable chance of improving the health of or preventing disease in participating individuals and is not overly burdensome, is not a subterfuge for discriminating based on a health factor, and is not highly suspect in the method chosen to promote health or prevent disease.") (emphasis added); 42 u.s.c. § 300gg-4)(3)(b) (2014) (adopting virtually identical language); 29 c.f.r. § 2590.702(f)(3)(iii) (2014) (adopting virtually identical language, with the additional provision that determinations regarding the "reasonable design" standard are "based on all the relevant facts and circumstances."). 127 see 29 u.s.c. § 1182 (2014) (prohibiting discrimination against individual health plan participants and beneficiaries based on health status) 128 see 29 u.s.c. § 1182(b)(2)(b) (2014). the 2006 rule further defined "evidence of insurability" to include: "(i) conditions arising out of acts of domestic violence; and (ii) participation in activities such as motorcycling, snowmobiling, all-terrain vehicle riding, horseback riding, skiing, and other similar activities." 29 c.f.r. § 2590.702(a)(2) (2007) (superseded). 129 see 29 u.s.c. § 1182(b)(2)(b) (2014). 130 hipaa, like the aca after it, amended provisions of the public health service act, the earned retirement income security act, and indiana health law review 2. the 2006 wellness program rule the 2006 rule distinguished between programs that condition a reward upon satisfaction of "a standard that is related to a health factor" and those that do not.132 for simplicity, i will refer to these as "standard-based" and "nonstandard-based." for non-standard-based programs (and those that do not offer a reward in the form of differential health plan benefits, cost-sharing mechanisms, premiums or contributions for similarly situated individuals), the only restriction imposed by the 2006 rule was that "participation must be made available to all similarly situated individuals, regardless of health status."133 wellness programs that do condition a reward (in the form of differential health plan benefits, cost-sharing mechanisms, premiums or contributions for similarly situated individuals) upon satisfaction of a standard related to a health factor were subjected to considerably greater regulation. five requirements for standard-based programs were set forth in the 2006 rule: first, the combined reward for achieving all available wellness program standards must not exceed 20% of the cost of coverage under the plan. second, the program must be "reasonably designed to promote health or prevent disease." the 2006 rule specified that this reasonable design requirement would be satisfied if a program "has a the internal revenue code. regulations implementing it fall under the purview of all three of these departments. 1s1 nondiscrimination and wellness programs in health coverage in the group market; final rules, 71 fed. reg. at 75,014 (dec. 13, 2006) (codified as amended at 26 c.f.r. pt. 54, 29 c.f.r pt. 2590, 45 c.f.r. pt. 146). 132 29 c.f.r. § 2590.702(f) (2007) (superseded). 133 see 29 c.f.r. § 2590.702(0(1) (2007) (superseded); 42 u.s.c. § 300gg-4(j)(2) (2014) (identical aca provision). these programs must also comply with employment and insurance laws that prohibit discrimination based on race, age, gender, religious beliefs and observances, and disability. a program that requires attendance at meetings on saturday mornings, for example, might be deemed to discriminate against members of certain religions. a participation-dependent incentive program that requires particular physical activities might need to be adjusted to accommodate employees with physical disabilities. 670 vol. 11:2 2014 aca's personal responsibility for wellness reforms 671 reasonable chance of improving the health of or preventing disease in participating individuals and it is not overly burdensome, is not a subterfuge for discriminating based on a health factor, and is not highly suspect in the method chosen to promote health or prevent disease."134 third, enrollees must have the opportunity to qualify for the reward at least once per year. fourth, the reward must be available to all similarly situated individuals. the 2006 rule specified that this uniform availability requirement would not be satisfied unless the program allowed "a reasonable alternative standard (or waiver of the otherwise applicable standard) for obtaining the reward for any individual for whom, for that period, it is unreasonably difficult due to a medical condition to satisfy the otherwise applicable standard" or for whom it is "medically inadvisable to attempt to satisfy the otherwise applicable standard." finally, the plan must disclose the availability of an alternative standard or waiver in all plan materials that describe the terms of the wellness program. 135 for brevity's sake, i will refer to these as the "five requirements" (see table 2). table 2: regulation of wellness programs under the 2006 rule non-standardstandard-based based participation in the 1) the total available reward for program must be all standard-based wellness made available to programs must not exceed 20% all similarly of the cost of coverage under situated the plan. individuals. 2) the program must be 134 see 29 c.f.r. § 2590.702(f)(2)(ii) (2007) (superseded); 42 u.s.c. § 300gg-4(j)(3) (2014) (nearly identical aca provision). 135 see 29 c.f.r. § 2590.702(f)(2) (2007) (superseded); 42 u.s.c. § 300gg-4(j)(3) (2014) (identical aca provision). indiana health law review reasonably designed to promote health or prevent disease. a program satisfies this standard if it has a reasonable chance of improving the health of or preventing disease in participating individuals and it is not overly burdensome, is not a subterfuge for discriminating based on a health factor, and is not highly suspect in the method chosen to promote health or prevent disease. 3) eligible individuals must be given the opportunity to qualify for the reward at least once per year. 4) the reward must be available to all similarly situated individuals. to satisfy this requirement, the program must allow a reasonable alternative standard (or waiver of otherwise applicable standard) for any individual for whom is its unreasonably difficult due to a medical condition to satisfy or medically inadvisable to attempt to satisfy the otherwise applicable standard. 5) the availability of a reasonable alternative standard or waiver (as set forth in requirement four) must be disclosed in plan materials describing the wellness program. vol. 11:2672 2014 aca's personal responsibility for wellness reforms 673 the test for determining whether a program would be regulated as standard-based was not fully fleshed out in the 2006 rule. some types of programs described in the rand study are easily classified as non-standard-based: employer responsibility programs (like rand employer b's healthy, low-cost lunch special in the cafeteria) enhance the work environment for all employees without offering financial rewards to anyone in particular and therefore would not be subject to the five requirements.136 programs offering incentives for participation in a health screening without regard to the results (like rand employer d's premium differential for health screening participation) would also not be subject to the five requirements because they do not distinguish among individuals based on health factors in any way. personal responsibility programs that provide incentives for participation in intervention programs (without regard to the results) and are nontargeted (in that they are offered to all individuals without regard to biometrics or risk factors) would also be in the clear.137 although these programs typically do relate to behaviors (like diet or exercise) that are associated with health, they do not adopt a particular health-related 136 among the examples of programs that do not condition a reward on a standard related to health status provided in the 2006 rule are three that clearly describe "employer responsibility" programs. see 29 c.f.r. § 2590.702(f)(1)(i) (2007) (superseded) ("a program that reimburses all or part of the cost for memberships in a fitness center."); 29 c.f.r. § 2590.702(f)(1)(iii) (2007) (superseded) ("a program that encourages preventive care through the waiver of the copayment or deductible requirement under a group health plan for the costs of, for example, prenatal care or well-baby visits."); 29 c.f.r. § 2590.702(f)(1)(iv) (2007) (superseded) ("a program that reimburses employees for the costs smoking cessation programs without regard to whether the employee quits smoking."). 137 among the examples of programs that do not condition a reward on a standard related to health status provided in the 2006 rule, are two that seem to describe non-targeted participation-dependent programs. 29 c.f.r. § 2590.702(f)(1)(ii) (2007) (superseded) ("a diagnostic testing program that provides a reward for participation and does not base any part of the reward on outcomes."); 29 c.f.r. § 2590.702(f)(1)(v) (2007) (superseded) ("a program that provides a reward to employees for attending a monthly health education seminar."). indiana health law review standard beyond mere participation. as non-targeted participation-only programs, they do not distinguish among individuals based on health status-related factors in any way. at the other end of the spectrum are programs that are easily classified as standard-based under the 2006 rule: "status-dependent" programs that provide rewards only to individuals who fall within particular health-related parameters clearly would be subject to the five requirements. similarly, "results-dependent" programs that provide rewards to individuals who achieve a particular outcome as the result of an interventional program (e.g., by actually quitting smoking or achieving a pre-defined weight loss or fitness goal) would also be treated as standard-based. 138 these programs condition a reward on a standard related to health factors, whether by singling out particular individuals directly based on health status (e.g., rand employer d's $754 premium differential tied to biometric data and clinical test results) or by doing so at the conclusion of an interventional program (e.g., the small percentage of employers who report offering financial incentives for diet or exercise programs tied to the achievement of particular weight loss goals). 138 the examples provided in the 2006 rule to illustrate standardsbased programs that do and do not comply with the five requirements all describe programs that provide rewards based solely on whether an employee falls within defined health-factor parameters. see 29 c.f.r. § 2590.702(0(3)(example 2) (2007) (superseded) ("a group health plan offers an annual premium discount of 20 percent of employee-only coverage to participants who adhere to a wellness program. the wellness program consists solely of giving an annual cholesterol test to participants. those participants who achieve a count under 200 receive the premium discount for the year."); 29 c.f.r. § 2590.702(f)(3) (example 4) (2007) (superseded) ("a group health plan will waive the $250 deductible ... for the following year for participants who have a body mass index between 19 and 26"); 29 c.f.r. § 2590.702(0(3) (example 5) (2007) (superseded) ("in conjunction with an annual open enrollment period, a group health plan provides a form for participants to certify that they have not used tobacco products in the preceding twelve months. participants who do not provide the certification are assessed a surcharge that is 20 percent of the cost of employee-only coverage."). 674 vol. 11:2 2014 aca's personal responsibility for wellness reforms 675 while some programs are easily classified as standardbased or not, the status of other programs described in the rand study was somewhat ambiguous under the 2006 ruleparticularly those that i have described above as "targeted" and "two-tier" (see table 3). the status of targeted and two-tier programs matters quite a lot given the rand study's indication that results-based rewards are relatively rare, while targeted and two-tier programs appear to be more common. 139 targeted participation-only incentive programs (which identify particular individuals as eligible for interventional programs based on screening results, then offer rewards to eligible individuals for participation without regard to the results) could arguably have been classified either way under the 2006 rule. similarly, "two-tier" programs that require participation in an interventional program as an alternative pathway for individuals who fail to satisfy an initial biometric or risk factor standard straddle the line between the two types of programs described in the 2006 rule. none of the examples provided in the 2006 rule clearly describes either a targeted or two-tier program. table 3: classifying wellness programs under the 2006 rule clearly nonambiguous clearly standardstandard-based based employer targeted status-dependent responsibility participation-only incentive programs 139 see rand report, supra note 38, at 83 (indicating that although 69% of employers offer financial incentives for participation, only between 3 and 12% of those employers offer what the rand report refers to as "results-based" incentives, depending on the type of program). as noted above, the rand study did not explicitly distinguish between targeted and non-targeted participatory programs, but survey results identifying the percentage of "eligible" employees who participated in interventional programs suggest that many, if not most interventional programs target particular employees by basing eligibility on health status-related factors like smoking status or body mass index. indiana health law review programs (e.g., employer offers a healthy, low-cost lunch special in the cafeteria) non-targeted participationonly incentive programs (e.g., any individual is eligible to receive a premium discount for participation in an onsite health screening or physical fitness program, without regard to results) incentive programs (e.g., individuals are deemed eligible for participation in an on-site weight management program if their body mass index is 26 or higher; eligible individuals receive a premium discount for attending the program, regardless of results) two-tier programs (e.g., individuals with body mass index under 26 receive a premium discount; individuals with body mass index of 26 or above are eligible to receive the same discount only if they attend a weekly onsite weight-loss program the 2006 rule states that "if any of the conditions for obtaining a reward under a wellness program is based on an (e.g., a premium surcharge is imposed on all individuals with a body mass index above 26) results-dependent incentive programs (e.g., individuals who lose 5% of their body weight over a defined period of time earn a premium discount) 676 vol. 11:2 2014 aca's personal responsibility for wellness reforms 677 individual satisfying a standard that is related to a health factor," then it must satisfy the five requirements to comply with hipaa's prohibition on health-status discrimination.14 0 ultimately, targeted and two-tier programs allow individuals to earn rewards merely for participating in an interventional program and therefore do not truly require individuals to satisfy a standard related to a health factor to obtain a reward. an interpretation that equates being "based on" satisfaction of a health-related standard with "requiring" satisfaction of a health-related standard as the only means to earn a reward would be reasonable and would exempt targeted and two-tier programs from the five requirements. indeed, the information reported about the two rand employers that have health status and risk factor reward adopted two-tier programs does not appear to indicate that the employers have treated those programs as being subject to the five requirements that the 2006 rule set forth for standardbased programs.141 on the other hand, it would also be reasonable to interpret "based on" satisfaction of a health-related standard more broadly to encompass programs that single out particular individuals for differential treatment based on whether they satisfy an initial health-related standard. under this interpretation, targeted and two-tier programs wouldbe subject to the five requirements. two-tier programs designate particular individuals for differential treatment by requiring them to participate in an intervention program to earn the same reward that other individuals earn simply by being themselves. under rand employer a's two-tier program, for example, non-smokers 140 see 29 c.f.r. § 2590.702(f)(2) (2007) (superseded) (emphasis added). 141 the report specifically notes that employer d's statusdependent incentive program complies with the 2006 rule by offering an alternative standard to employees for whom it would be impossible due to a medical condition to achieve or medically inadvisable to attempt satisfaction of the primary standard. see rand report, supra note 38, at 86. similar information is notably absent with regard to the two-tier programs offered by employers a and c. indiana health law review automatically avoid the $50 annual insurance premium surcharge, while smokers must participate in an interventional program to avoid the penalty. two-tier programs might be characterized as status-dependent incentive programs that include a second tier to meet the "reasonable alternative standard" requirement. if that is the case, however, then the adoption of a second tier to satisfy (and only partially) one of the five requirements of the 2006 rule should not automatically exempt the program from the remaining requirements set forth for standardbased programs by reclassifying it as non-standard-based. for example, simply because rand employer a offers a participation-only pathway to receive the same reward offered to non-smokers based on their status alone, should not mean that the employer is exempt from offering an alternative to participating in the cessation program (which may include the use of cessation aids like nicotine patches or gum) for individuals for whom it would be medically inadvisable. targeted programs designate particular individuals for differential treatment by deeming them eligible for participation-dependent rewards while other individuals are not. although targeted programs might be understood as giving preferential treatment to "unhealthy" individuals while deeming "healthier" individuals ineligible for incentives, the singling out of particular individuals as "unhealthy" and in need of education, instruction, counseling, or physical activity could create a hostile work environment. this concern is particularly salient for employees targeted on the basis of their weight, given that weight-based employment discrimination and harassment is widespread and has significant negative impacts on both physical and psycho-social health.142 to the extent that the 2006 rule's definition of standardbased wellness programs could be construed narrowly to subject only statusand results-dependent programs to 142 see wiley, shame, supra note 18, at 174 (describing the ways in which workplace wellness programs might contribute to stigma and discrimination based on weight). 678 vol. 11:2 2014 aca's personal responsibility for wellness reforms 679 significant regulation, the wellness program exception to hipaa's general prohibition on health-factor discrimination was quite broad. the status of targeted and two-tier programs is important. as noted above, the rand study indicates that these types of programs are considerably more common than statusand results-dependent programs. while they do not raise the specter of "backdoor" health-status underwriting to quite the same extent that status-dependent programs do, they could drive away "unhealthy" employees by creating an environment that is hostile to those who smoke, are overweight, or have other biometric risk factors. in this sense, targeted and two-tier programs (just like status-dependent programs) might cut an employer's health care costs not by prompting employees to become healthier, but rather by shifting costs onto unhealthy employees. status-dependent programs shift costs to unhealthy employees directly by charging them higher deductibles, copays or coinsurance. targeted, twotier, and results-dependent programs have the potential to shift costs away from an employer by driving unhealthy employees out of that particular employer's workforce. 3. the wellness program exception in the aca inspired by media reports of successful employer wellness programs,143 congress adopted and expanded the wellness program exception in 2010 as part of the aca. as noted above, the aca incorporated language from hippa's statutory text.144 it also incorporated significant language 143 see steven a. burd, how safeway is cutting health -care costs, wall st. j. (june 12, 2009, 12:01 am), http://online.wsj.com/article/ sb124476804026308603.html (an op-ed piece by the ceo of safeway, inc., arguing that congress should "raise the federal legal limits" on workplace wellness incentives), archived at http://perma.cc/9ftxluwn; hilzenrath, supra note 74 (describing how reports regarding the safeway wellness program influenced the workplace wellness amendment and questioning previous reports of the safeway program's success). 144 see supra note 123. indiana health law review from the 2006 rule.145 particularly interesting, however, are the subtle changes that congress made to the exception. on the one hand, congress seemingly "doubled down" on wellness programs by raising the cap on the overall value wellness program incentives from 20% to 30% across the board with flexibility for implementing agencies to raise it as high as 50%.146 on the other hand, the text of the aca includes a few other seemingly minor alterations to the language of the 2006 rule. in particular, the aca added a key phrase to its description of the uniform availability requirementl 47 confirming that dhhs has flexibility to 145 see supra note 124. 146 under the 2006 rule, the combined reward for achieving all available wellness program standards could not exceed 20% of the employee's cost of coverage under the plan. see 29 c.f.r. § 2990.702(f)(2)(i) (2007) (superseded). the aca raises this cap to 30% and gives the secretaries of labor, treasury, and health and human services additional authority to extend it to 50%. see 42 u.s.c. § 300gg-4(j)(3)(a). 147 compare 29 c.f.r. § 2590.702(2)(iv) (2007) (superseded) ("the reward under the program must be available to all similarly situated individuals. (a) a reward is not available to all similarly situated individuals for a period unless [the program makes a reasonable alternative standard or waiver available to particular employees for whom it would be unreasonably difficult due to a medical condition to achieve or medically inadvisable to attempt to satisfy the otherwise applicable standard].") with 42 u.s.c. § 300gg-4(j)(3)(d) (2014) ("the full reward under the wellness program shall be made available to all similarly situated individuals. for such purposes, among other things: (i) the reward is not available to all similarly situated individuals for a period unless [the program makes a reasonable alternative standard or waiver available to particular employees for whom it would be unreasonably difficult due to a medical condition to achieve or medically inadvisable to attempt to satisfy the otherwise applicable standard].") (emphasis added). the addition of the phrase "among other things" in the text of the aca provides additional support for the argument that congress intended to grant the implementing agencies discretion to impose additional requirements as the agency deemed necessary. thus, although commentators do not appear to have anticipated that the 2013 rule would be considerably more protective of employees than the 2006 rule, the greater protection provided by the agencies in the 2013 rule appears to be consistent with the language of the statute and with congressional intent to prohibit the use of wellness programs as a subterfuge for health-status discrimination. other subtle changes also 680 vol. 11:2 2014 aca's personal responsibility for wellness reforms 681 impose additional regulatory requirements on the most concerning types of programs to ensure that incentives are available to all employees and not used as a subterfuge for discrimination, as congress intended. these subtle, but important changes paved the way for dhhs to narrow the wellness program exception in the 2013 rule, as described below. 4. the 2013 wellness program rule the final rule on incentives for nondiscriminatory wellness programs in group health plans issued by dhhs and the departments of labor and treasury in 2013 fleshed out the wellness program exception in considerably greater detail than the 2006 rule. ultimately, the 2013 rule significantly narrowed the wellness program exception to hipaa and aca non-discrimination provisions by subjecting broader categories of programs to more stringent requirements and thus affording greater protection to employees from health-related discrimination. the 2013 rule labels and defines three categories of wellness programs: (1) "participatory wellness programs," (2) "activity-only health-contingent wellness programs," and (3) "outcome-based health-contingent wellness programs" and subjects each to distinct regulatory requirements. first, the 2013 rule re-styles the non-standard-based category from the 2006 rule as "participatory" and the indicate congressional intent to give the agency discretion to tighten the regulations applicable to wellness programs. for example, a partial grandfathering clause notes that wellness programs established prior to the enactment of the aca that complied with all applicable regulations (presumably referencing the 2006 rule) may continue to be carried out for as long as those regulations remain in effect. the most reasonable interpretation of this provision is that congress intended for wellness programs that pre-date the aca (and were compliant with the 2006 rule) to be required to comply with any more stringent regulations that the agencies might ultimately promulgate superseding the 2006 rule. see 42 u.s.c. § 300gg-4(k)(2) (2014). indiana health law review standard-based category as "health-contingent."148 it then defines "health-contingent" more clearly than the 2006 rule defined "standards-based." under the 2013 rule, the implementing agencies classify a program as healthcontingent (and thus subject to the five requirements) if it "requires an individual to satisfy a standard related to a health factor to obtain a reward" or "requires an individual to undertake more than a similarly situated individual based on a health factor in order to obtain the same reward."149 in doing so, the agencies effectively adopt the broader reading of the phrase "based on an individual satisfying a standard that is related to a health status factor" (which was imported from the 2006 rule into the text of the aca), discussed above. whereas the status of targeted and two-tier programs under the 2006 rule was ambiguous and there was some evidence in the rand report that employers did not treat them as subject to the five requirements, under the 2013 rule, targeted and twotier programs are clearly treated as health-contingent and subjected to greater regulation. the 2013 rule goes on to subdivide health-contingent programs into "activity-only" and "outcome-based." "an activity-only wellness program is a type of healthcontingent wellness program that requires an individual to perform or complete an activity related to a health factor in order to obtain a reward but does not require the individual to attain or maintain a specific health outcome." 5 0 this definition encompasses targeted participation-only incentive programs, which single individuals for participation based on health factors and further "relate to" those health factors by aiming to alter them.15 arguably, activity-only health-contingent programs 148 see 29 c.f.r. § 2590.702(f)(1)(ii) (2014) (defining participatory wellness programs); id. at § 2590.702(f)(1)(iii) (defining healthcontingent wellness programs). 149 id. 150 id. 151 the examples provided in the rule describe a participation-only walking program that targets individuals based on body mass index as an activity only program. see id. § 2590.702(f)(4)(vi)(example 4)(ii). 682 vol. 11:2 2014 aca's personal responsibility for wellness reforms 683 would also encompass all participation-only incentive programs, but there must be a sensible line between participatory programs and activity-only health-contingent programs, given that the 2013 rule recognizes a "participatory wellness program" category and subjects it to minimal regulation in the way that the 2006 rule treated "non-standard-based" programs. the examples of participatory programs provided in the 2013 rule all describe either employer responsibility programs 152 or nontargeted participation-only incentive programs that do not require physical activity.153 the examples of activity-only health-contingent programs provided in the 2013 rule include what appears to be a non-targeted participationonly incentive program that does require physical activity.154 a sensible conclusion then is that although most non-targeted participation-only incentive programs are 152 see id. § 2590.702(f)(1)(ii)(a) ("a program that reimburses employees for all or part of the cost for membership in a fitness center."); id § 2590.702(f)(1)(ii)(c) ("a program that encourages preventive care through the waiver of the copayment or deductible requirement under a group health plan for the costs of, for example, prenatal care or well-baby visits."). 15s see id. § 2590.702(f)(1)(ii)(b) ("a diagnostic testing program that provides a reward for participation in that program and does not base any part of the reward on outcomes."); id § 2590.702(f)(1)(ii)(d) ("a program that reimburses employees for the costs of participating or that otherwise provides a reward for participating, in a smoking cessation program without regard to whether the employee quits smoking."); id § 2590.702(f)(1)(ii)(e) ("a program that provides a reward to employees for attending a monthly, no-cost health education seminar."); id § 2590.702(f)(1)(ii)(f) ("a program that provides a reward to employees who complete a health risk assessment regarding current health status, without any further action (educational or otherwise) required by the employee with regard to the health issues identified as part of the assessment."). 154 see id. § 2590.702(f)(3)(iv) ("a group health plan provides a reward to individuals who participate in a reasonable specified walking program. if it is unreasonably difficult due to a medical condition for an individual to participate (or if it is medically inadvisable for an individual to attempt to participate), the plan will waive the program requirement and provide the reward. all materials describing the terms of the walking program disclose the availability of the waiver. . . . the program satisfies [the five requirements]."). indiana health law review treated as "participatory" under the 2013 rule, targeted participation-only incentive programs that require physical activities that may be inaccessible to some employees based on their health factors are regulated as activity-only healthcontingent programs. 155 notably, these programs might readily have been understood to be non-standards-based programs that were subject to the most minimal regulation under the 2006 rule, while the 2013 rule subjects them to the five requirements. finally, outcome-based health-contingent wellness programs are defined to encompass any program "that requires an individual to attain or maintain a specific health outcome (such as not smoking or attaining certain results on biometric screenings) in order to obtain a reward."156 this definition clearly encompasses the statusand results-dependent incentive programs that were already subject to the five requirements under the 2006 rule. but the 2013 rule goes on to clarify that the fact that an outcome-based wellness program offers an alternative pathway to obtain the same reward (via participation in an intervention program) to all individuals who fail to meet the initial standard (as required by the heightened "reasonable 155 some confusion remains, however, about the status of targeted participation-dependent incentive programs for smoking cessation under the 2013 rule. a workplace wellness program that directs identified smokers to a smoking cessation program and provides them with a reward for participation regardless of whether they actually quit smoking would seem to fit the regulatory definition of an activity-only health-contingent program, subject to the weaker form of the five requirements. a two-tiered program that identifies non-smokers and rewards them and then offers the same reward to smokers only if they participate in a smoking cessation program would be bumped up to an outcome-based health-contingent program subject to the stronger form of the five requirements. on the other hand, the 2013 rule describes an incentive for participating in a smoking cessation program as an example of a participatory program not subject to the five requirements at all. notably, smoking status is also singled out for less protection by the higher cap on rewards for smoking cessation programs. as noted above, the differential treatment of smoking may be explained by the fact that an independent aca provision permits insurers to charge higher premiums to tobacco users (at a ratio of 1 to 1.5). e56 id. § 2590.702(f)(1)(v). 684 vol. 11:2 2014 aca's personal responsibility for wellness reforms 685 design" requirement described below) does not render the program "participatory" or even "activity-based." 5 7 "[i]f a measurement, test, or screening program is used as part of an initial standard and individuals who meet the standard are granted the reward, the program is considered an outcome-based wellness program." the regulations also provide an example for further clarification: [i]f a wellness program tests individuals for specified medical conditions or risk factors (including biometric screening such as testing for high cholesterol, high blood pressure, abnormal body mass index, or high glucose level) and provides a reward to individuals identified as within a normal or healthy range for these medical conditions or risk factors, while requiring individuals who are identified as outside the normal or healthy range (or at risk) to take additional steps (such as meeting with a health coach, taking a health or fitness course, adhering to a health improvement action plan, complying with a walking or exercise program, or complying with a health care provider's plan of care) to obtain the same reward, the program is an outcome-based wellness program.158 thus, two-tier programs (which were arguably nonstandard-based programs under the 2006 rule) are clearly subject to the most stringent regulation under the 2013 rule. table 4 summarizes the classification of various types of wellness programs under the 2013 rule. 157 _[d 158 id. indiana health law review table 4: classifying wellness programs under the 2013 rule participatory activity-based outcomehealth contingent based health contingent employer responsibility programs (e.g., employer offers a healthy, low-cost lunch special in the cafeteria) non-targeted participation-only incentive programs that do not involve physical activity (e.g., any individual is eligible to receive a premium discount for participation in an onsite health screening or health education seminar, without regard to results) non-targeted participation-only incentive programs that involve physical activity (e.g., any individual is eligible to receive a reduction in their co-pay for participating in a walking program, without regard to results) targeted participation-only incentive programs (e.g., individuals are deemed eligible for participation in an on-site weight management program if their body mass index is 26 or higher; eligible individuals receive a premium discount for attending the program, regardless of status-dependent incentive programs (e.g., a premium surcharge is imposed on all individuals with a body mass index above 26) resultsdependent incentive programs (e.g., individuals who lose 5% of their body weight over a defined period of time earn a premium discount) two-tier programs (e.g., individuals with body mass index under 26 receive a premium discount; 686 vol. 11:2 2014 aca's personal responsibility for wellness reforms 687 results) individuals with body mass index of 26 or above are eligible to receive the same discount only if they attend a weekly onsite weight-loss program in addition to resolving ambiguity over which categories of plans are subject to the five requirements, the 2013 rule also elaborates upon those requirements in a way that ensures their stringency as a barrier to "back-door" healthbased underwriting. the 2013 rule creates two distinct versions of the five requirements imported from the 2006 rule into the aca-one for activity-based programs and another for outcome-based programs-and elaborates additional factors and requirements applicable to each. table 5 summarizes these regulatory requirements. indiana health law review table 5: regulation of wellness programs under the 2013 rule participatory activityoutcome-based based healthhealth-contingent contingent participation in the program must be made available to all similarly situated individuals. same as the five requirements under the 2006 rule, except: 1) cap on reward value is raised to 30% (50% for smoking). 2) if the reasonable alternative standard is an educational program, the plan must make it available or assist the employee in finding a program, the time commitment must be reasonable, and if the alternative is a diet program, the plan must pay the same as for activitybased programs, except: 1) the program must provide an alternative standard to any individual who does not meet the initial standard; the plan may not seek verification from an individual's personal physician that a health factor makes it unreasonably difficult for the individual to satisfy, or medically inadvisable to attempt to satisfy the otherwise applicable standard. 2) if the alternative standard is itself an outcome-based program, it too must comply with the five requirements. 3) the alternative standard cannot be a requirement to meet ai vol. 11:2688 2014 aca's personal responsibility for wellness reforms 689 membership or participation fee. 3) the alternative standard must accommodate any recommendation s of the individual's personal physician regarding medical appropriateness 4) if the alternative standard is itself an activity-only program, it too must comply with the five requirements different level of the same standard without additional time. 4) an individual must be given the opportunity to comply with the recommendations of her personal physician as an alternative to meeting the alternative standard defined by the plan. the most notable enhancement to the requirements for activity-only programs relate to the uniform availability and reasonable alternative standard requirements. to be considered uniformly available, an outcome-based program must allow a reasonable alternative standard for obtaining the same reward (or a waiver of the standard altogether) for any individual for whom it is unreasonably difficult due to a medical condition to satisfy or medically inadvisable to attempt to satisfy the otherwise applicable standard.15 9 the 1e id. § 2590.702(f)(3)(iv)(a)(1)-(2). the rule clarifies that a plan or issuer may seek verification, including a statement from an indiana health law review rule also specifies several factors that will be among those taken into account in determining whether the program satisfies the uniform availability requirement: "if the reasonable alternative standard is completion of an educational program, the plan or issuer must make the educational program available or assist the individual in finding such a program (instead of requiring an individual to find such a program unassisted), and may not require an individual to pay for the cost of the program." 6 0 additionally, "[ilf the reasonable alternative standard is a diet program, the plan or issuer is not required to pay for the cost of food but must pay any membership or participation fee."161 the time commitment required must also be reasonable.162 with regard to outcome-based programs, the reasonable design requirement is significantly expanded as compared to the 2006 rule. "to ensure that an outcome-based wellness program is reasonably designed to improve health and does not act as a subterfuge for underwriting or reducing benefits based on a health factor, a reasonable alternative standard to qualify for the reward must be provided to any individual who does not meet the initial standard based on the measurement, test, or screening that is related to a health factor."163 this is an important new requirement that will go a long way toward ensuring that wellness programs are not simply used to shift costs onto less healthy individuals. previously, the only individuals for whom a reasonable alternative standard must be offered were those whose personal physicians could verify, upon request, that they met the "unreasonably difficult/medically inadvisable" standard. the 2013 requirement, in contrast, requires an alternative pathway for all individuals who do individual's personal physician that an employee falls into this category. see id. § 2590.702(f)(3)(iv)(e). 160 id. § 2590.702 (f)(3)(iv)(c)(1). presumably the same requirement would apply to the initial standard and not only the reasonable alternative standard. 161 id. § 2590.702(f)(3)(iv)(c)(3). 162 id. § 2590.702(f)(3)(iv)(c)(2). 163 id. § 2590.702(f)(4)(iii) (emphasis added). vol. 11:2690 2014 aca's personal responsibility for wellness reforms 691 not meet the initial outcome-based standard. this requirement effectively renders statusand resultdependent programs (which surveys indicate are extremely popular among large employers) considerably less attractive by imposing considerable burdens on employers or health plans to pay for individuals to participate in alternative programs and by allowing many employees to obtain the same reward without satisfying outcome-based standards (by requiring programs to offer compliance with the recommendations of the individual's personal physician as an alternative, regardless of whether the individual has a medical excuse for not satisfying or attempting to satisfy the initial standard. it requires that these programs follow the two-tier model, and it seems likely that in many cases, that second (or third, or fourth) alternative tier will ultimately have to be a non-outcome-based alternative. c support for small business workplace wellness programs in addition to the wellness-programs exception for group health plans, the aca authorized the appropriation of $200 million for grants to businesses with fewer than 100 employees to establish "comprehensive" workplace wellness programs. 164 the statute defined "comprehensive' programs as those that include (1) "[health awareness initiatives (including health education, preventive screenings, and health risk assessments)"; (2) "[e]fforts to maximize employee engagement (including mechanisms to encourage employee participation)"; (3) "[i]nitiatives to change unhealthy behaviors and lifestyle choices (including counseling, seminars, online programs, and self-help materials)"; and (4) "[s]upportive environment efforts (including workplace policies to encourage healthy lifestyles, healthy eating, increased physical activity, and improved mental health)."165 164 see patient protection and affordable care act, pub. l. no. 111148, 124 stat. 119, 978, § 10408(e) (2010). 165 id. indiana health law review congress has failed to appropriate funds for the statutory grant program. nonetheless, in 2011, dhhs announced that it was making $10 million from the aca's prevention and public health fund available to support workplace wellness programs for employers with fewer than 100 employees that did not previously have a program in place.166 this program appears to be responsive to some aspects of the statutory small business grants while also fulfilling another aca. provision's mandate that the u.s. centers for disease control and prevention provide technical support for workplace wellness provisions. 167 the agency ultimately awarded grants to establish and evaluate a new national network to provide technical support to between 70 and 100 large and small employers developing new wellness programs. 168 while the statutory criteria for the small business grant program primarily emphasize personal responsibility programs and incentives for participation in them, the program that dhhs ultimately created has a much stronger emphasis on employer responsibility. the concrete examples described in the award announcement could all be described as employer responsibility programs with a particular emphasis on changes to the worksite environment: "tobacco-free campus policy, subsidized quitsmoking counseling (quitlines, health plans, others) [; w]orksite farmer's market, nutrition counseling/education, menu labeling on healthy foods, healthy foods in cafeterias and vending, weight management counseling[; and s]tairwell enhancement, physical fitness/lifestyle 166 press release, dep't health and human servs., $10 million in affordable care act funds to help create workplace health programs (june 23, 2011). 167 see 42 u.s.c. § 2801 (2014); see also healthier worksite initiative, ctrs. for disease control and prevention, http://www.cdc.gov/nccdphp/dnpaolhwi/ (last updated feb. 9, 2010) (the cdc provides this support directly, in addition to funding support and evaluation by private organizations.). 168 workplace health promotion, ctrs. for disease control and prevention, http://www.cdc.gov/workplacehealthpromotion/nhwp/ (last updated oct. 23, 2013), archived at http://perma.cc/8udd-az76. 692 vol. 11:2 2014 aca's personal responsibility for wellness reforms 693 counseling, walking trails/clubs, flextime policy."169 the announcement also notes that successful programs will "create a health-promoting environment that establishes a culture of health within the worksite."170 d. the individual insurance wellness program demonstration project although the aca extended anti-discrimination protections to the individual market, the wellness program exception discussed above remains restricted to the group market. rather than allowing individual-market insurers to adopt wellness programs right away, the statute mandated that dhhs establish a ten-state demonstration project whereby states will be allowed to apply the wellness program provisions to the individual market.171 by statute, the initial demonstration project must be established no later than july 2014, with authorization to extend the program to additional states in 2017. the statute sketches out several requirements for approval of a state's participation in the demonstration project, designed to ensure that the program does not run counter to the aca's broader goals. states may permit premium discounts or rebates or alter otherwise applicable copays or deductibles as a reward for "adherence to, or participation in, a reasonably designed program of health promotion and disease prevention."172 however, the secretaries must design the project so as to avoid any decrease in coverage or increase in cost to the federal government in terms of premium assistance and costsharing reduction subsidies offered via the exchanges.173 participating states must also ensure that various consumer protection requirements imposed on individualmarket plans are satisfied by demonstration project plans 169 id 170 id. 171 see 42 u.s.c. § 300g-4() (2014). 172 id. 173 id. § 300g-4 (3)(a)(i)-(ii). indiana health law review and must require verification from participating health insurance issuers that discounts "do not create undue burdens" for insureds, "do not lead to cost shifting," and "are not a subterfuge for discrimination."17 4 while the mid-2014 deadline looms closer, as of this writing, dhhs has taken no apparent action to implement it. the agencies did not address the demonstration project in any way in the 2013 rule, in spite of comments from the american association of health plans urging them to do so.175 e. the medicaid incentives for prevention of chronic disease program just as many private health plans have adopted incentive-based personal responsibility for wellness programs, several states (who take on the role of third party payers with respect to the medicaid program) have also sought to establish incentive-based personal responsibility for wellness programs for medicaid recipients. federal law restrains the ability of states to impose premium contributions and cost-sharing arrangements on medicaid recipients, but those restraints were loosened considerably by the 2005 deficit reduction act ("dra"). shortly thereafter, dhhs granted several section 1115 waivers that allowed states to adopt a wide range of experimentation in this area. as described below, dhhs implementation of this program reflects growing skepticism toward programs that tie the terms of coverage to risk factors and health 174 id. 175 letter from daniel t. durham, executive vice president, & thomas j. wilder, senior counsel, america's health insurance plans, to u.s. department of labor 9 (jan. 25, 2013) ("it will take time for states to apply for the demonstration project and design wellness programs and for insurers to implement the programs. we believe it is critical for hhs to work with stakeholders and to release the program requirements as soon as possible in order to allow such wellness programs in the individual market starting in 2014."), available at http://op.bna.com/hl.nsflid/shad94dsh2/$file/wellness%20incentives%20proposed%2orule%2ocomments% 20(ahip,%2001.25.13).pdf, archivedathttp://perma.cc/53u-36a9. 694 vol. 11:2 2014 aca's personal responsibility for wellness reforms 695 outcomes and greater emphasis on third-party-payer responsibility. 1. federal restraints on the implementation of incentive-based personal responsibility for wellness medicaid programs medicaid was designed to meet the particular needs of very low-income families and disabled adults and thus has traditionally included many features that make it distinct from private health insurance. 176 prior to the dra, states were prohibited from charging monthly premiums in any amount and nominal co-pays were permitted only for certain recipients.'77 the dra gives states considerably greater freedom to redesign their medicaid programs in ways that bring them into line with typical private health plans. states are permitted to adopt these changes without the need for a section 1115 waiver, though they do require submission of a state plan amendment to dhhs.178 states are permitted to shift many recipients into privatized managed care plans. 7 9 they may also charge monthly premiums to recipients living above 150% of the federal poverty level ("fpl"). states may require greater cost sharing-up to the levels typically seen in many private health plans-for many medicaid recipients'8 0 (with the 176 the medicaid program at a glance, the henry j. kaiser family found. (mar. 4, 2013), http://kff.org/medicaid/fact-sheet/themedicaid-program-at-a-glance-update/, archived at http://perma.cc/ ljr9-khpn. 177 see dep't of health & human servs., the deficit reduction act: important facts for state government officials, available at http://www.cms.gov/regulations-andguidance/legislation/deficitreductionact/downloads/checklistl.pdf, archived at http://perma.cc/tu8c-muvs. 178 dep't of health and human services, understanding medicaid home and community services 163 (2000), available at http://aspe.hhs.gov/daltcp/reports/primer.pdf. 179 deficit reduction act of 2005, pub. l. 109-171, 120 stat. 4, § 6044 (2006). 180 recipients living above 100% fpl may be required to pay up to 10% of covered services; recipients above 150% fpl may be charged up indiana health law review exception of true emergency services, 181 family-planning services, and preventive services for kids) are provided for recipients living above 100% fpl.182 states may also permit health care providers to require payment from recipients at the point of service before care is provided. the statute established a cap on aggregate premium and cost-sharing expenses, prohibiting them from exceeding 5% of a family's monthly income, though enforcement of the cap may be beyond the administrative capacity of many state programs. certain groups are protected from premiums and cost sharing, including children below independently specified levels of poverty, pregnant women, institutionalized adults, and those in hospice care. the door remained open for states to impose harsher premiums or cost sharing through section 1115 waivers. 2. medicaid wellness program waivers prior to the a ca in the years following passage of the dra, dhhs granted section 1115 waivers quite liberally for stateinitiated demonstration projects that incorporated personal responsibility for wellness directly into the terms of coverage. incentive-based programs in three statesflorida, idaho, and west virginia-have garnered particular attention from researchers. florida's program offered incentives for medical and lifestyle compliance. idaho and west virginia went considerably further, blurring the line between incentives and penalties by initially reducing the quality of coverage for all beneficiaries and then offering enhanced coverage as a reward for wellness program participation and results. in 2005, florida obtained a waiverl 83 that shifted many of the state's medicaid recipients into private managed care to 20%. id. § 6041. co-pays may also be charged for prescription drugs. id. § 6042. 181 a separate provision of the dra specifically allows cost sharing for non-emergency use of emergency room services. id. § 6043. 182 id. §§ 6041-43. 183 the initial waiver was granted for a five-year period. see ctrs. for medicare & medicaid servs., medicaid reform section 1115 696 vol. 11:2 2014 aca's personal responsibility for wellness reforms 697 plans and instituted the "enhanced benefit reward$ program," which was designed to encourage individuals to improve their individual health behaviors.184 recipients complying with any of nineteen identified health behaviors (ranging from getting a recommended pap smear or an annual flu shot to participating in smoking cessation, weight loss, or diabetes management programs), they became eligible for vouchers ranging in value $7.50 to $25, up to a total of $125 per year.185 vouchers were redeemable for medical goods not otherwise covered by medicaid, like over-the-counter medicines and band-aids.186 the enhanced benefits can be placed into two categories: those that are services provided by a doctor and "community programs."187 particularly for interventional lifestyle programs, which the florida plan defined as "community demonstration, available at http://www.fdhc.state.fl.us/medicaid/ medicaidreform/waiver/pdfs/cms-special terms and conditions.pdf. it was then extended for three additional years. see letter from cindy mann, director, ctrs. for medicaid & medicare servs., to elizabeth dudek, secretary, fla. agency for health care admin. (dec. 15, 2011), available at http://www.fdhc.state.fl.us/medicaid/medicaid-reform/pdfl cmsapprovaluletter_12-15-2011.pdf, archived at http://perma.cc/ pk4g-se64. 184 jessica greene, ctr. for health care strategies, inc., medicaid efforts to incentivize healthy behaviors 4 (2007), available at http://www.chcs.org/usrdoclmedicaideffortsto_ incentivizehealthybehaviors.pdf, pat redmond et al., center on budget and policy priorities, can incentives for healthy behavior improve health and hold down medicaid costs? 2 (2007), available at http://www.cbpp.org/files/6-1-07health.pdf. 185 greene, supra note 184, at 1; fla. agency for health care admin., enhanced benefits reward$ program (2011), http://www.fdhc.state.fl.us/medicaid/medicaidreformlenhabben/ebcod esasof_7_26_2011.pdf [hereinafter enhanced benefits]. 186 redmond et al., supra note 184, at 2; greene, supra note 184, at 7; enhanced benefits, supra note 185. 187 cf enhanced benefits, supra note 185 (listing all enhanced benefits as of july, 2011); greene, supra note 184, at 4 (citing fla. agency for health care admin., enhanced benefits accounts program frequently asked questions [#11 4 (2006), available at http://www.fdhc.state.fl.us/medicaid/medicaidreform/enhabben/ebacc ounts-programfaq1_091206.pdf [hereinafter enhanced benefits faq]) (discussing community programs). indiana health law review programs" that have "defined goals and or milestones[,] provide information, guidance, andlor assistance for specific behaviors[,] and are accessible to the public"188-it was fairly onerous for recipients to obtain the vouchers. the recipient was required to submit an "enhanced benefit universal form" to the health plan. 189 the recipient was required to get a health care provider or the sponsor of the interventional program was required to specify the beginning and end dates of the healthy behavior, "and sign the form before forwarding it to the health plan." 90 an assessment of the florida program published in 2013 found that virtually all of the rewards earned by participants in the program were for receiving recommended check-ups, with less than 1% of rewards received for participation in lifestyle programs,191 representing two individuals (out of the more than 400,000 who were automatically enrolled in the program) who earned credits for participating in a smoking-cessation program (one of whom was not smoking six months after initiating the program) and two individuals who earned credits for participation in an exercise program.192 as of this writing, the florida enhanced benefits program is being phased outl 9 3 while the state transitions to a new demonstration project, as described below. in 2007, idaho received a waiver to develop two incentive-based wellness programs, which the state referred 188 greene, supra note 184, at 4 (citing enhanced benefits faq, supra note 185, at 4). 189 lucinda jesson, weighing the wellness programs: the legal implications of imposing personal responsibility obligations, 15 va. j. soc. poi'y & l. 217 (2008). 190 id. 191 blumenthal et al., supra note 14, at 499. 192 id. at 498. 193 after july 1, 2014, recipients will no longer be able to earn vouchers, and after june 30, 2015, recipients will not be able to redeem vouchers. see letter from melanie brown-woofter, chief, bureau of health sys. dev., to reform health plans (july 31, 2013), available at http://www.fdhc.state.fl.us/medicaid/medicaidreform/enhabben/dhpre_ enhancedbenefitprogram phaseoutnotice_1_7-31-13.pdf, archived at http://perma.cc/wa6q-p3cx. 698 vol. 11:2 2014 aca's personal responsibility for wellness reforms 699 to as "preventive health assistance" ("pha") programs. 194 the first, called the "behavioral pha" targeted individuals for weight management or smoking cessation.195 participants were rewarded for meeting with a health-care provider to develop a weight-management or smokingcessation plan. those who successfully quit smoking were entitled to a second reward. although a results-dependent reward was initially planned for the weight-management program as well, it was ultimately determined that such a strategy put too much emphasis on losing weight, rather than on living healthfully. 196 similar to the florida program, rewards under this program took the form of credits that could be used to pay for counseling, diet and exercise programs, and nicotine replacement products. 97 an assessment published in 2013 found that fewer than 1500 (out of a pool of approximately 185,000 recipients) participated in the first two years of the program.198 the state did not assess the program's impact on actual cessation and weight control. 9 9 idaho's second program, called the "wellness pha," tied rewards directly to cost-sharing requirements by offering participants credits toward the payment of monthly premiums as a reward for reporting for recommended wellchild visits. 200 an evaluation published in 2013 suggests that the program significantly increased the proportion of children who had received recommended well-child care. 194 greene, supra note 165; preventative health assistance, idaho dep't of health and welfare, http://healthandwelfare.idaho.gov/ medical/medicaid/preventivehealthassistance/tabid/221/default.aspx (last visited dec. 5, 2013) [hereinafter preventative health assistance], archived at http://perma.cc/k7nj-f2ju. 195 redmond et al., supra note 184, at 5; preventive health, supra note 194. 196 greene, supra note 184. 197 redmond et al., supra note 184, at 5; aimee miles, medicaid to offer rewards for healthy behavior, kaiser health news (apr. 11, 2011), http://www.kaiserhealthnews.org/stories/2011/april/08/medicaidincentives.aspx; greene, supra note 184, at 8. 198 blumenthal et al., supra note 14, at 499. 199 id. 200 greene, supra note 165. indiana health law review consistent with other data regarding the impact of incentives, the evaluation found that "[tihe largest increase in adherence occurred with children requiring only one annual visit" with gains declining for each additional recommended visit per year. 201 beginning in 2006, west virginia took additional steps to condition the terms of health-care coverage to medical and lifestyle compliance. abandoning its original benefits package, west virginia now has two tiers of medicaid benefits: a default package referred to as "basic," and a more robust plan referred to as "enhanced."202 however, the "basic" plan offers fewer benefits than its predecessor. 203 recipients could access the enhanced package if they "sign and conform to an agreement with the state that they will engage in certain behaviors."204 participating recipients agree to attend health improvement programs as directed by their health care providers, report on-time for recommended check-ups and other appointments, take prescribed medications as directed, use the hospital emergency room only for emergencies, and "do [their] best to stay healthy." 205 some of the benefits included in the enhanced plan but not the basic plan simply amount to coverage of wellnessrelated services such as programs like weight management, smoking cessation, diabetes education, nutritional 201 blumenthal et al., supra note 14, at 499. 202 sheryl mitnick et al., ethical considerations for the use of patient incentives to promote personal responsibility for health: west virginia medicaid and beyond, am. coll. of physicians 3 (2010), http://www.acponline.org/running-practice/ethics/issues/policy/personal -incentives.pdf. 203 thomas j. parisi, the onus is on you: wellness plans and other strategies being employed for patients to take ownership of their health, 13 quinnipiac health l.j. 243, 269-70 (2010). however, some beneficiaries (those over sixty-five, disabled, or in foster care at the time of the reforms) were allowed to keep the old benefits plan. robert steinbrook, imposing personal responsibility for health, 355 new engl. j. med. 753, 754 (2006). 204 redmond et al., supra note 184, at 4. 205 steinbrook, supra note 203, at 775. 700 vol. 11:2 2014 aca's personal responsibility for wellness reforms 701 counseling, and substance-abuse treatment. 206 other benefits, however, are unrelated to wellness services and offer significantly more comprehensive access to health care. these include more comprehensive prescription-drug, transportation, skilled nursing, and mental-health-care benefits.207 notably, many services crucial to appropriate management of chronic disease are covered only under the enhanced plan, including patient-centered diabetes management and pulmonary rehabilitation services. 208 to maintain these benefits, recipients are required to comply with the health improvement plan. compliant recipients are also rewarded with credits placed in a "healthy rewards account," which can be used to purchase services not otherwise covered by medicaid, such as gym memberships and healthy foods. 209 an assessment published in 2013 found that only 10% of eligible adults have enrolled in the enhanced plan,210 meaning that the vast majority were simply downgraded into less comprehensive health-care coverage. those who are enrolled in the enhanced plan have more office visits and are more likely to take prescribed medications than those who did not enroll.211 3. medicaid incentives for the prevention of chronic disease grant program new federal grants established under the aca are providing further support for states to experiment with 206 mitnick et al., supra note 202, at 3; steinbrook, supra note 203. 207 redmond et al., supra note 184, at 4; dep't of health and human res., chapter 527 covered services, limitations, and exclusions for mountain health choices 12-43 (2009) [hereinafter chapter 5271, available at http://www.dhhr.wv.gov/bms/documents/ bmsmanualschapter_527mountainhealthchoices.pdf at 12-43 (describing terms of coverage under the basic and enhanced plans). 208 chapter 527, supra note 207, at 27-43 (describing several preventive and disease management benefits available only under the enhanced plan). 209 robert steinbrook, supra note 203, at 754. 210 blumenthal et al., supra note 14, at 500. 211 id. indiana health law review incentive-based wellness programs aimed at tobacco cessation and weight, cholesterol, and blood-pressure management, and diabetes prevention and management. 212 the statutory provision specifies that grants should be awarded to states "to carry out initiatives to provide incentives to medicaid beneficiaries who-(i) successfully participate in a [wellness program]; and (ii) upon completion of such participation, demonstrate changes in health risk and outcomes, including the adoption and maintenance of healthy behaviors by meeting specific targets." 213 this language clearly contemplates outcomebased health-contingent programs. furthermore, the statute mandates that recipient states "validate changes in health risk and outcomes with clinical data, including the adoption and maintenance of health behaviors by such beneficiaries" and "to the extent practicable, establish standards and health status targets for medicaid beneficiaries participating in the program and measure the degree to which such standards and targets are met."2 14 at least one commentator expressed concern that "[w]hat counts as a permissible incentive is not specified in the act," leaving the door open for states to "try to use more coercive incentives than would be permitted in private health plans" in response to the statutory requirement that the programs "'validate' beneficiary progress."215 in 2011, dhhs created the medicaid incentives for the prevention of chronic disease ("mipcd") grant program to provide states with a total of $85 million over five years to "test the effectiveness of providing incentives directly to medicaid beneficiaries . . . who participate in the mipcd prevention programs, and change their health risks and 212 patient protection and affordable care act, pub. l. 111-148, 124 stat. 119, 562, § 4108(a)(3) (2010). 213 id. § 4801(a)(1)(a). 214 id. § 4108(c). 215 wendy mariner, the affordable care act and health promotion: the role of insurance in defining responsibility for health risks and costs, 50 duq. l. rev. 271, 287 (2012). 702 vol. 11:2 2014 aca's personal responsibility for wellness reforms 703 outcomes by adopting healthy behaviors."216 the ten programs receiving funding feature a strong emphasis on the responsibility of the state to provide coverage of wellness-related services (such as smoking cessation or weight management programs). for example, wisconsin's program features provision of tobacco-cessation counseling and education for health care providers regarding the resources available to medicaid beneficiaries. 217 new hampshire's program randomizes participants into programs that cover gym membership, gym membership plus sessions with a personal fitness trainer, weight watcherstm, or weight watcherstm plus gym membership and personal trainer sessions.218 most of the programs provide small financial incentives unrelated to the terms of coverage for participation only.2 19 one state, texas, provides a larger incentive in the form of a flexible spending account. 220 all of the programs offer 216 see mipcd: the states awarded, ctrs. for medicare & medicaid servs., http://innovation.cms.gov/initiatives/mipcdfmipcdthe-states-awarded.html (last visited apr. 26, 2014), archived at http://perma.ccn523-r2f4. 217 ctrs. for medicare & medicaid servs., mipcd state summary: wisconsin [hereinafter mipcd wisconsin], available at http://innovation.cms.gov/files/x/mipcd-wi.pdf, archived at http://perma.cc/cg4d-u2k7. 218 ctrs. for medicare & medicaid servs., mipcd state summary: new hampshire [hereinafter mipcd new hampshire], available at http://innovation.cms.gov/files/x/mipcd-nh.pdf, archived athttp://perma.cc/3m53-zq55. 219 for example, california's program provides $20 to reward medicaid beneficiaries who call a helpline, complete the intake protocol, and participate in counseling sessions. ctrs. for medicare & medicaid servs., mipcd state summary: california, available at http://innovation.cms.gov/files/x/mipcd-ca.pdf, archived at http://perma.cc/6j4f-887w; hawaii's program offers $25 to beneficiaries who attend the first session of a smoking cessation, behavioral health counseling, or diabetes education program. ctrs. for medicare & medicaid servs., mipcd state summary: hawaii, available at http://innovation.cms.gov/files/x/mipcd-hi.pdf, archived at http://perma.cc/kj48-y5y6. 220 mipcd state summary. texas, ctr. for medicare & medicaid servs., available at http://innovation.cms.gov/files/x/mipcd-tx.pdf, archived at http://perma.cc/5za4-sgn2. indiana health law review participation-dependent incentives, while six of the ten programs offer some form of results-based incentive. 221 of those six, only three are for an outcome other than smoking cessation, 222 and only two appear to involve clinical measurement (as opposed to self-report) as a means for validating health outcomes.223] 221 programs in wisconsin, new hampshire, and connecticut offer rewards for actual smoking cessation. mipcd wisconsin, supra note 218; mipcd new hampshire, supra note 218; ctrs. for medicare & medicaid servs., mipcd state summary: connecticut [hereinafter mipcd connecticut], available at http://innovation.cms.gov/files/x/ mipcd-ct.pdf, archived at http://perma.cc/ta57-ru8q. new york's program offers rewards for smoking cessation and for specified outcomes with regard to blood pressure, weight, and glycated hemoglobin (a marker indicative of diabetes disease management). ctrs. for medicare & medicaid servs., mipcd state summary: new york [hereinafter mipcd new york], available at http://innovation.cms.gov/files/x/mipcd-ny.pdf, archived at http://perma.cc/z5v6-9q6s. nevada's program, which is aimed at reducing weight, cholesterol, and blood pressure and at managing and preventing diabetes offers incentives for achievement of unspecified "improved health outcomes." ctrs. for medicare & medicaid servs., mipcd state summary: nevada [hereinafter mipcd nevada], available at http://innovation.cms.gov/files/x[mipcd-nv.pdf, archived at http://perma.cc/qz5b-6n7z. minnesota's program, which is aimed at weight loss, offers rewards for unspecified "goal attainment and goal maintenance." ctrs. for medicare & medicaid servs., mipcd state summary: minnesota [hereinafter mipcd minnesota], available at http://innovation.cms.gov/files/x/mipcd-mn.pdf, archived at http://perma.cc/662j-8e83. 222 mipcd wisconsin, supra note 217; mipcd new hampshire, supra note 218; mipcd connecticut, supra note 221; mipcd new york, supra note 221; mipcd nevada, supra note 221; mipcd minnesota, supra note 221. 223 connecticut's program offers a $15 reward for each negative result on a breathalyzer test that detects smoking in the previous fortyeight hours. mipcd connecticut, supra note 221. new york's program offers rewards for "decreasing or maintaining a decreased systolic blood pressure by 10mmhg or achieving another clinically appropriate target;" for "decreasing [glycated hemoglobin] by 0.6 percent or maintaining a level of 8.0 percent or less;" or for "losing or maintaining a reduced weight." mipcd new york, supra note 221. 704 vol. 11:2 2014 aca's personal responsibility for wellness reforms 705 4. post-a ca medicaid waiver decisions the supreme court's 2012 decision making the medicaid expansion optional for states224 has given states even more bargaining power in seeking flexibility from cms through waivers. 225 some of these waiver requests include the use of incentive-based wellness programs. in 2013, cms approved a new section 1115 waiver to allow florida to fully privatize its medicaid program, shifting nearly all of the state's medicaid recipients into managed care plans operated by private insurance companies. 226 information provided by the state regarding this new demonstration project specifies that the managed care plans "will also establish programs to encourage and reward healthy behaviors" for smoking cessation, weight loss and alcohol or substance abuse recovery. 227 as part of a compromise reached in the iowa state legislature over whether to accept the aca's medicaid expansion, the state sought section 1115 waivers to allow it to experiment with two new ways of covering adults aged nineteen through 64,228 many of whom are newly eligible for medicaid under the aca expansion. the state's proposal 224 nat'l fed'n indep. bus. v. sebelius, 132 s. ct. 2566 (2012). 225 robert alt &nathaniel stewart, buckeye institute for pub. policy solutions, medicaid waivers are temporary, expansion is forever (2013), available at https://www.mackinac.org/archives/2013/s2o13-06.pdf, archived at http://perma.cc/8cxf-fpgf. 226 joan ackler & jack hoadley, jesse ball dupont fund, medicaid managed care in florida (2013), available at http://www.dupontfund.org/wp-content/uploads/2013/10/medicaid-brieffall-2103.pdf, archived at http://perma.cc/c23k-egaj. 227 fla. agency for health care admin., florida managed medical assistance program: an overview 9 (feb. 2013), available at http://www.ahca.myflorida.com/medicaid/statewide_mc/pdf/mma/overview of_managedmedical assistance-program_02-12-2013.pdf, archived at http://perma.cc/m2gj-ynev. 228 certain individuals-those with disabling mental disorders, chronic substance abuse disorders, serious and complex medical conditions, physical, intellectual or developmental disability-would be exempt from both plans and would be enrolled in a traditional medicaid plan. indiana health law review for two distinct plans was approved by cms in december 2013 (along with a similar proposal submitted by michigan). under iowa's "marketplace choice plan," adults living at between 101% and 133% fpl are be enrolled in commercial health plans available through the state's health insurance exchange (purchased with federal funds), rather than being enrolled in the public medicaid program. 229 the state's second waiver application for the "iowa wellness plan,"230 under which adults between 50% and 100% fpl will be charged monthly premiums amounting to as much as 5% of their income, with a "waiver" available as a reward for completion of wellness activities was also approved. the premiums will not be charged to any beneficiaries during the first year, but any beneficiary who has not completed a health risk assessment and clinical exam by the end of 2014 will be charged monthly premiums beginning in 2015. after 2014, additional "wellness activities" will be required to avoid monthly premiums. as of this writing, a third waiver request tied to the medicaid expansion and incorporating personal responsibility for wellness incentives, submitted by pennsylvania, was still pending review. other states have indicated interest in similar approaches and are certainly taking notice of recent cms decisions. 231 for example, the governor of idaho has indicated that he would only consider expanding medicaid 229 iowa dep't of health servs., iowa marketplace choice plan 1115 waiver application (aug. 2013), available at http://www.dhs.state.ia.us/uploads/iamktplacechoicelll5final.pdf ,archived at http://perma.cc/w7gf-cz6g. 230 iowa dep't of health servs., iowa wellness plan 1115 waiver application (2013), available at http://www.dhs.state.ia.us/ uploads/iawellnessplan1115_final.pdf, archived at http://perma.cc/ k4s6-tp5z. 231 see, e.g., kevin miller, senator rethinks bill to deny health care to smokers, bangor daily news (mar. 1, 2011, 7:58 pm), http://bangordailynews.com/2011/03/0 1/health/senator-rethinks-billtodeny-health-care-to-smokers/ (reporting that senator tom saviello introduced a bill to prohibit smokers from receiving maine health care benefits in order to start a dialogue about the cost smokers place on maine taxpayers), archived at http://perma.cc/33ul-fdq9. vol. 11:2706 2014 aca's personal responsibility for wellness reforms 707 eligibility if there were some provision for "requir[ing] more personal responsibility and better health outcomes." the governor's statements indicate that he is clearly contemplating a punitive approach: "if you're smoking, you gotta quit smoking .. . and if you don't quit smoking, some part of the benefit, or all of it, goes away. if you've got a history of diabetes in your family, and you're told to change a certain lifestyle, and you don't do it, then you don't get [benefits] anymore." 232 cms approval of the iowa and michigan plans might be taken as evidence that the agency is quite comfortable with incentive-based wellness programs that make access to health care contingent upon healthy behavior. an argument could perhaps even be made that while dhhs and other implementing agencies have taken a stance protective of individuals who are privately insured, they have failed to extend the same protection to those poor enough to qualify for medicaid. it seems more likely, however, that the cms approvals are simply the product of state's assuming a superior negotiating position as a result of the supreme court's 2012 decision. expanding medicaid eligibility in iowa and michigan while allowing the imposition of premiums and cost-sharing terms that penalize individuals for non-compliance with wellness goals might easily be weighed as a better alternative to having the state refuse the expansion.233 in any case, rigorous evaluation of these demonstration projects could provide useful information about the impact of wellness incentives for medicaid recipients. 232 audrey dutton, idaho gov. otter wants more personal accountability in medicaid, idaho statesman (may 30, 2013) http://www.idahostatesman.com/2013/05/30/2595854/carrots-and-sticksfor-medicaid.html, archived at http://perma.cc/b4ss-bd4c. 233 see, e.g., tim martin, michigan house repubhlicans introduce broad medicaid plan with ime limits, expanded coverage, mlive.com (may 9, 2013, 7:49 pm), http://www.mlive.com/politics/ index. ssf/2013/05/michigan-house-republicans_det.html (reporting that michigan's legislature proposed expanding the population of those eligible for medicaid in exchange for implementing personal responsibility measures that would affect the entire medicaid population), archived at http://perma.cc/68yp-2h6v. indiana health law review iii. conclusion recent agency actions implementing a c lection of aca reforms designed to promote personal responsibility for wellness indicate appropriate skepticism toward an approach that places the onus on individuals to change their behavior, without necessarily making it more feasible for them to do so. the agency-commissioned rand report provides a much-needed antidote to hyperbolic wellness industry claims regarding the potential public-health benefits and cost savings of incentive-based programs. it also provides the foundation for expertise-driven administrative implementation of aca wellness provisions. the 2013 final rule on group-based wellness programs sharply curtails the most punitive approaches and should offer greater protection than its predecessor against the use of wellness incentives as a pretext for shifting health-care costs to individuals who are perceived as unhealthy. the individual market demonstration project and small business grant program are less far along in their implementation, but they create promising opportunities for hhs to continue to emphasize the importance of insurer and employer responsibility interventions such as enhanced coverage for wellness-related goods and services and worksite improvements that facilitate healthier choices. it is encouraging that state programs receiving funds under the medicaid wellness incentives grant program largely emphasize participation-only incentives, with minimal representation of biomarker-based rewards and no measures that tie the terms of coverage directly to wellness program engagement. the tilt of these funded programs toward payer responsibility may provide a clue as to the agency's likely response to pending waiver requests that would take a more punitive approach. altogether, agency implementation of these provisions represents an important step in the right direction. but continued vigilance is necessary to ensure that third-party payers do not use wellness reforms to undermine the aca's goals with respect to health care access and disease prevention. 708 vol. 11:2 2014 aca's personal responsibility for wellness reforms 709 beyond curtailing undesirable practices (from a public health standpoint) by third-party payers, the question remains whether public-health advocates might be able to enlist those payers in their efforts to tackle some of the most powerful, upstream drivers of chronic diseases like diabetes and heart disease. i have argued elsewhere that we are nearing a political crossroads in the effort to prevent obesity-related disease.234 powerful industries are expending considerable resources to sway policymakers at every level of government away from interventions aimed at creating work, school, and marketplace environments that are more conducive to healthy living. personalresponsibility measures are generally more politically palatable and fiscally conservative and they have the backing of the wellness industry, which stands to profit from their implementation. ironically, local governmentswho, unlike states and the federal government, do not play a significant role in paying health-care costs-have been among the most innovative pioneers in this effort.235 the federal government, which funds the medicare program in its entirety, has perhaps the greatest financial stake in chronic-disease prevention, but federal action is stymied by a dysfunctional legislature. state legislatures are poised to become a key battleground, but many of them are blocking local efforts through preemption legislation rather than implementing meaningful reforms.236 a powerful new ally-in the form of private insurers and state-government payers--could provide leverage for public health advocates at a crucial time. 234 see wiley, shame, supra note 18. 235 see paul a. diller, why do cities innovate in public health? implications of scale and structure, 91 wash. l. rev. (forthcoming 2014). 236 see, e.g., bill lueders, banning local rules is national strategy, wisconsinwatch.org (may 28, 2013), http://www.wisconsinwatch.org/ 2013/05/28/banning-local-rules-is-national-strategy/. notes steven h. pratt steven h. pratt is a shareholder with hall, render, killian, heath & lyman and practices in general health law with representation of hospitals and health systems. several areas of concentration are corporate law, governance, mergers and acquisitions, anti-kickback, stark bill, tax issues affecting exempt organizations, licensure and regulatory concerns, ·and organizing and advising physician and hospital joint venture relationships. steve is based in the firm's downtown indianapolis office. hospital-physician joint venture relationships: a useful tool to improve hospital services steven h. pratt* table of contents i. introduction ....•..••••....•.....•••.••..•••••••••.......•.....•••.•.•••...........•......• 242 ii. the benefits of p ar1nering with physicians in joint ventures .......•••.•..•.•••......••....•.•...•••...••••....••.....•.•....••.....•.•.•..•.•••.. 243 a. joint ventures' emergence as a preferred under arrangement ............................................................................. 244 b. enhancing health care quality by integrating physician expertise ................................................................................... 246 c. increasing physician management capacity ........................... 246 d. expanding new services and purchasing new equipment ...... 241 e. other benefits of joint ventures ............................................... 248 f. recruitment of new physicians and keeping services alive in the community ..................................................................... 249 ill. legal considerations of joint ventures ...••..••••••..•.......••.•••. 249 a. stark law ................................................................................. 250 1. personal service arrangements ......................................... 250 2. fair market value ............................................................. 251 3. indirect compensation arrangements ............................... 251 b. anti-kickback ........................................................................... 252 1. space rental ...................................................................... 253 2. equipment rental .............................................................. 253 3. personal services and management contracts exception 253 4. per-click arrangements .................................................... 254 c. hospital's tax-exempt status .................................................. 255 1. private inurement and private benefit prohibitions ......... 255 2. sale of revenue stream arrangements .............................. 255 3. use of bond financed property-revenue procedure ........ 255 4. unrelated business income ............................................... 256 5. fair market value opinion ............................................... 256 d. civil monetary penalty ............................................................ 256 n. operational and quauty efficiency incentives for use in billing "under arrangement" relationships ...................... 256 a. operational efficiency incentive compensation ...................... 251 1. inventory turns .................................................................. 251 • shareholder, hall, render, killian, heath, &lyman, p.c. adjunct professor, indiana university school of law, indianapolis, indiana. 242 indiana health law review [vol. 4:239 2. first case on-time start ................................................... 257 3. room turnaround time .................................................... 258 4. utilization of block schedule ............................................. 258 5. patient discharge .............................................................. 259 b. quality of services incentive compensation ............................ 259 1. core measures for acute a1yocardiallnfarctions ............. 259 2. congestive heart failure core measures ......................... 259 3. patient satisfaction ............................................................ 259 4. associate and physician satisfaction ................................. 260 5. time out/universal protocol compliance ........................ 260 6. other outcome measures .................................................. 260 v. conclusion ................................................................................... 261 i. introduction hospitals faced with mounting pressure to stay financially viable must contend with an increasingly complex environment where competition, pressure to reduce costs, and constant government scrutiny must be carefully factored into every business growth decision. for those hospitals that are tax-exempt, maintaining their exempt status is complicated by additional factors such as political pressure to provide more charity care, 1 response to public concerns when medical mistakes or poorly provided care occurs within their institutions,2 and the criticisms of high compensation paid to hospital executives. 3 when hospitals also factor in the need to stay competitive while controlling costs, it is not surprising that many search for innovative ways to improve efficiency and minimize spending in order to remain current with their competitors. one mar­ ket strategy that has gained favor in allowing hospitals to expand health care services and business opportunities in their communities has been the use of an "under arrangements" relationship,4 or an arrangement pursuant to a "provider based" arrangement. 5 while "under arrangements" have been recognized for many years by the federal government as a legitimate model for providing health care services, these "partnerships" have been gradually gaining renewed popularity as hospitals have sought to increase physician involvement in efforts to expand market share and increase the quality of patient care. hospitals have progressively realized that the joint venture business model provides a unique 1 see fred bazzoli, grassley continuing to increase pressure for community benefit reporting, healthcare fin. news, jan. 1, 2007, at http://www .healthcarefinancenews.com/story.cms?id=5764. 2 see vic ryckaert, baby's kin blame nurses for her death, lndianapous star, sept. 22, 2006, at a 1. 3 see walt bogdanich, hospital chiefs get paid for advice on selling, n.y.times, july 17,2006, at ai. 4 42 u.s.c. § l395x(w) (2000). 5 see42 c.f.r. § 413.65 (2006). 2007] hospital-physician joint venture relationships 243 opportunity to partner with specialty doctors to provide sophisticated services that are relevant to what the market demands while allowing the hospital to branch out into new markets.6 ii. the benefits of p ar1nering with physicians in joint ventures traditionally, the use of services providing '"under arrangements" has al­ lowed a hospital to obtain specialized health care services that it was otherwise unable to provide or secure services that could be provided more effectively by a subcontractor, such as a laboratory or occupational therapy service provider. the current movement to "under arrangement," "provider based," and other business or joint ventures between hospitals and physicians has allowed hospi­ tals to remain competitive in an environment where inpatient hospital days are dwindling due to the continued flow of health services and procedures to the outpatient setting. 7 in practice, these arrangements are increasingly being util­ ized in the form of joint ventures between hospitals and specialty physician groups. 8 the use of joint ventures is appealing to hospitals because it allows them to engage a third party (often a physician group) to perform certain ser­ vices on behalf of the hospital while allowing the hospital to lawfully bill medicare and other third-party payors for the services provided. further, it al­ lows hospitals an opportunity to increase access for their patients to clinical experts in highly specialized areas such as cardiology. while working in col­ laboration with physicians has been a significant challenge for some hospital systems, the traditional walls between physicians and hospitals are being tom down as the demand for high quality care, more efficient care, and greater ac­ cess to higher-end technological treatments requires an innovative approach to structuring business arrangements. in order to maintain a viable joint venture relationship, the hospital must assume the responsibility to ensure the arrangement complies with certain gov­ ernment regulations in order to receive reimbursement from the federal gov­ ernment for services provided through the partnership. hospitals have ultimate accountability to ensure that all health care services provided as hospital ser­ vices are properly designed, organized, and evaluated as part of their ongoing utilization review, quality assurance, and peer review activities. 9 in this era of cost-effective health care, where there are parallel demands by patients for higher quality care and by physicians for increased control and financial security in the marketplace, the use of a joint venture relationship al6 healtiicarefin.mgmt.ass'n,flnancingtiiefurureiireport4:jointventures with physicians and orner partners 4 (2006) (hereinafter financing tile furore report 4]. 7 fitch ratings. com, outpatient business growth: nonprofits hospitals' struggle for volume (sept. 1 0, 2004 ), http://www .fitchratings.com/corporate/sectors/report _ index.cfin. 8 ira j. rappeport, "under arrangements" joint ventures: a newly popular form of hospital-physician integration, boardroom press, the governance institijte, aug. 2005. 9 42 u.s.c. § 1395x(w) (2000). 244 indiana health law review [vol. 4:239 lows hospitals and physicians to align common incentives and financial goals to work together to improve the quality and efficiency of care, and meet the grow­ ing needs of the health care market. a. joint ventures' emergence as a preferred under arrangement the continuing pressure to modernize services and act in accordance with ever-changing federal and state regulatory requirements often creates additional obstacles for hospitals seeking to improve care and further develop their service lines.10 government and private payors, however, are beginning to look for ways that health care providers can work together to improve the quality of care and create positive health outcomes for their beneficiaries. recently, the gov­ ernment demonstrated this commitment to finding new solutions to promote quality care by becoming more flexible and supportive of collaborative efforts in the marketplace between hospitals and third parties. 11 for example, the gov­ ernment approved select gain-sharing arrangements and ultimately revoked the moratorium on specialty hospitals' construction. 12 with limited but growing government acceptance, hospitals are reconsidering how to creatively collabo­ rate with physicians to decrease costs and improve overall health care utiliza­ tion. the trend for many hospitals has been to capitalize on the movement towards investing in specialty hospital services by seeking to partner with phy­ sicians who are positioned to expand specialized services, or to capture new and growing markets along a specific service line, such as diagnostic imaging. the use of a joint venture with physicians, whether structured pursuant to the "under arrangements" rules, the "provider based" rules, or another model, pro­ vides hospitals and physicians with a powerful tool to collaborate on managing long-term costs while concurrently improving quality and clinical outcomes.13 joint ventures can involve either a short or long-term relationship. usu­ ally the partnership developed is between a hospital or health system and a pro­ vider entity (usually a physician group) where the risk and benefits are shared with the purpose of creating a common business enterprise to expand or provide new services. 14 joint ventures can be generally characterized in one of three ways: defensive, offensive, or a combination of the two. 15 defensive joint ven­ tures are typically formed where the hospital has a perceived or real threat from 10 john r. boettinger, jr. & teresa t. young, healthcare joint ventures: a cfo primer, healtiicare fin. mgmt., oct. 2004, at 36, 36-40. 11 james j. pizzo & lewis red.d, hospital-physician joint ventures: maximizing the potential, healtiicarefin. mgmt., nov. 2006, at 80, 80-83. 12 jessica b. applegate & kathy kuhagen, deficit reduction act of 2005 addresses various health issues, 18 healtiilawyer31, 31-32(2006). 13 42 c.f .r. § 412.52 (2006); rappeport, supra note 8. 14 financing tile future report 4, supra note 6, at 3. 15 craig e. holm & alan m. zuckerman, profitable joint ventures: a real-lifo ap' proach, managing tile margin, july 2005, at 1. 2007] hospital-physician joint venture relationships 245 a competitor that may infringe upon a new or existing service line. hospitals often choose a more defensive strategy when forming joint ventures in an at­ tempt to create a synergistic model with a physician group that would ultimately end up a competitor.16 on the other hand, some hospitals will take a more pro­ active stance by creating offensive joint ventures, which typically indicates there is no competitive threat that would force the hospital to react to a market change. typically, the offensive approach marks the hospital's expansion of an existing service line or opening up of services into a new market.17 combina­ tion joint ventures involve aspects of both a defensive and offensive arrange­ ment where, for example, a hospital may be entering a new market with a new service but will do so with a group of physicians that pose a potential competi­ tive threat to its existing service line or market share. regardless of the model adopted, there are many advantages for hospitals and physicians that choose to participate in a joint venture. 18 if the hospital takes the initiative to create a joint venture (a more offensive approach), many advantages may follow. for example, taking the leadership role in the negotia­ tions can provide the hospital more leverage with which to influence the terms and tone of the discussions in developing the relationship. a more proactive stance may allow the hospitals to retain majority control over the fate of the venture. further, if the hospital is tax-exempt, then the joint venture can be structured to preserve the hospital's nonprofit and tax-exempt status.19 from the physicians' point of view, joint ventures are a favorable business model that allows them the ability to supplement or stabilize what has been for many physicians, declining income and reimbursement rates. further, by par­ ticipating in the joint venture, physicians are empowered to play a more mean­ ingful role in the management and operation of a hospital service line.20 in an effort to be "partnership" minded, physicians are often willing to accept ami­ nority or equal ownership in a joint venture, as they understand that hospitals are better able to handle the regulatory, reimbursement, and tax issues that will be critical to the success of the business. ultimately, hospitals seek to obtain services through "under arrangements," "provider based," or other joint venture relationships expecting that the relationship with their physician partners will enhance the quality of the services, control costs, and increase efficiency that will help keep their organizations competitive. additionally, hospitals see po­ tential joint ventures as an opportunity to bring new services to the community and provide access to capital from outside investors (e.g., physician groups) that is necessary to purchase new equipment that will eventually enhance patient care. 16 boettinger & young, supra note 10, at 3 7; see also holm & zuckerman, supra note 15, at 3. 17 financing tiffi future report 4, supra note 6, at 3. 18 boettinger & young, supra note 10, at36-37. 19 id at39. 20 financing tiffi future report 4, supra note 6, at 3. 246 indiana health law review [vol. 4:239 b. enhancing health care quality by integrating physician expertise from a clinical quality perspective, a joint venture with physicians is a valuable arrangement because the physicians can contribute significant techni­ cal expertise and clinical focus which, in turn, places the business arrangement in a position to have a greater chance for success.z1 additionally, physicians can have a positive impact on operational effectiveness and regulatory compli­ ance by improving patient throughput (total number of patients cared for in a given period· of time), productivity, sourcing and utilization of supplies, and coordinating of clinical personnel needs. 22 if the joint venture is designed properly, the different skill sets the physicians and hospitals possess regarding operations and management can complement each other creating an organiza­ tion well-positioned to better serve the community. an example is illustrated by a group of physicians who collaborate with a hospital to manage an outpa­ tient surgery center. if the physicians and hospital, working together, are suc­ cessful in reducing the operating room turnover time and reducing surgical supply utilization, a win-win model has been created. not only is the hospital's bottom-line improved, but the increased productivity and efficiency paves the way for increased patient satisfaction.z3 the benefit of having physicians in a leadership and management role is that the entire joint venture team is keenly focused on the entire clinical practice, which leads to incentives to improve quality and reduce operational costs. at the same time, health care services are being provided that otherwise might not have been possible had the joint ven­ ture not been created. c. ·increasing physician management capacity hospitals will occasionally enter into a joint venture agreement with a physician-led group to provide management oversight for a defmed set of ac­ tivities for the hospital (e.g., surgezy or a catheterization lab). this manage­ ment service agreement may involve physician and non-physician investors who are typically service line experts. 24 utilizing physicians who have the fun­ damental knowledge of day-to-day hospital operations brings an understanding of clinical practice that can be easily applied to improve quality and efficiency of care. for example, standardization of supplies and equipment and control of staffing numbers are common areas where physicians are able to make signifi­ cant contributions to right-sizing inventory and personnel. a physician-led management team will often be more aware of what actions are necessary to 21 pizzo & redd, supra note 11, at 82-83. 22 ld. at 83. 23 /d. at 82-83. 24 /d. at 82. 2007] hospital-physician joint venture relationships 247 ensure the staff performs at the highest level possible.25 health care industry leaders recognize the impact a vested physician group can play in making a hospital system more efficient. during a senate homeland security and government affairs committee hearing on the com­ petitive effects of specialty hospitals, john thomas, baylor health care sys­ tem's former senior vice president and general counsel noted, "[e]conomic investment motivates physicians to bring their time, energy and talent to the design, operation and governance of more effective and efficient health care facilities."26 mr. thomas also testified that the physician efforts led to his facil­ ity being among one of the highest rated heart programs in the united states, noting an elimination of $12 million of costs to provide services before the heart hospital was even opened. further, mr. thomas testified about other ef­ forts in his facility to retain key personnel stating that "staff turnover is less than 11% per year, while the rest of our system exceeds 20%."27 decreasing turnover can lead to huge cost savings not only in replacing and retraining a new hire, but in ensuring continuity of care for patient teams is not disrupted, which can directly affect patient care and satisfaction. 28 d. expanding new services and purchasing new equipment joint ventures also provide opportunities for hospitals to expand existing services or, as is sometimes the case, introduce new services to the community. for example, a hospital system in indiana was working toward replacing an existing facility when a for-profit company began offering physicians in the area partnership opportunities. using an "under arrangements" joint venture, the hospital was able to move forward to replace its facility and expand the ser­ vices available in its ambulatory surgery center and heart center. in this sce­ nario, the hospital was not the only one who benefited from the joint venture; the physicians were offered the opportunity to invest in tax-exempt bonds, pro­ viding needed capital to the hospital. although the physician investment cre­ ated an acceptable level of investment risk that would not be misconstrued as a sham investment, they were still able to legitimately receive relatively high tax­ exempt interest rates. 29 in addition, the hospital provided management and 25 an overview of the competitive effects of specialty hospitals: hearing before s. comm. on homeland security and government affairs, fed. fin. mgmt., gov 't information and international security subcomm., 1 09th cong. 3, 5 (2005) (statement ofjohn t. thomas, sen­ ior vice president, general counsel, baylor health care system) [hereinafter competitive ef­ fects of specialty hospitals]. 26 id. at 4-5. 27 /d. 28 /d. at 5 (noting that to replace a registered nurse at baylor is close to $60,000 per nurse for recruiting, training, and retention). 29 healthcarefin.mgmt.ass'n,financingthefu'rureiireport2:jointven1ures with physicians and other p ar1ners 12 (2005) [hereinafter fina."'lcing the future report 248 indiana health law review [vol. 4:239 payment incentives that encouraged the physicians to meet quality and effi­ ciency targets, which helped improve the financial standing of the hospital while also benefiting the physicians and the community. with the cost of medical devices and pharmaceuticals dramatically in­ creasing in the past few years, hospitals and physicians have responded by en­ tering into financial relationships in which both share the burden to subsidize the increased costs.30 whether through the purchase of newer, more powerful medical devices or by providing additional units to increase capacity, many hospitals have realized that pursuing a joint venture that requires physician capital investment can ultimately create a reliable partner in building and shar­ ing the risks of creating a successful business venture. likewise, physicians have realized that partnering with hospitals no longer leaves them shouldering the financial burdens alone or tied to an economic model that may not lead to success without the help of a larger hospital. if, for example, a certain medical device is limited in supply and is very expensive, it is unlikely that the hospital will purchase the device without obvious market signs that such an investment is worthwhile. through a joint venture, however, a hospital is more likely to invest in the device when physician expertise is utilized as part of an overall market analysis and strategic plan.31 e. other benefits of joint ventures generally, the joint venturing of physicians with a hospital brings addi­ tional economic benefits to the community. as mentioned above, the new infu­ sion of capital can be used for new equipment, but the possibilities for additional health care improvements do not end there. with the additional in­ vestment and influence that the physicians bring to the joint venture, other re­ sources can be redeployed by the hospital to meet any number of needs. an example of this community benefit is demonstrated by the baylor health care system. as lydia jumonville, the senior vice president and chief financial officer explained, the physician-hospital partnership provided ''the opportunity to offer other advantages, such as our employee benefits program, economies of scale in purchasing equipment and supplies, and managed care contracting. '.32 through the joint venture, the health care system realized additional down­ stream benefits to the hospital employees. the increased purchasing power created by the new joint venture allowed the hospital to negotiate more favor­ able terms with different managed care providers and equipment vendors, which in turn allowed for the hospital to save dollars that would have been du­ plicated in other areas of the health care delivery system. 2]. 30 pizzo & redd, supra note 11, at 81. 31 jonathan m. joseph, hospital joint ventures: charting a sqfe course through a sea of antitrust regulations, 13 am.j.l. &med. 621,622 (1988). 32 financing 11fe furur.e report 2, supra note 29, at 22. 2007] hospital-physician joint venture relationships f. recruitment of new physicians and keeping services alive in the community 249 physician recruitment is a topic that extends beyond the discussion of this article; however, joint ventures offer unique opportunities for a community to support physician recruitment and retention. often the prospects of a joint ven­ ture with revenue sharing opportunities and state-of-the-art facilities present an attractive package to physicians who are considering different practice options and locations. further, many physicians recognize that a joint venture repre­ sents a significant investment in the community. the physicians will share in the benefits and risks and, therefore, are motivated to enhance the quality of care provided to their patients. by having the entrepreneurial opportunity to invest in a new service in a community, the community benefits from the direct involvement of physicians in the ownership and operations of the respective service line. furthermore, joint ventures may present a unique practice model for health services that otherwise would have been discontinued in a community. while most joint ventures are created to maximize returns on investment, many such business arrangements ultimately subsidize charity care in other hospital service areas that may be losing money and often provide direct care to the poor and uninsured who otherwise would not have access to care for such services in the community. as john thomas testified before the senate homeland secu­ rity and government affairs committee, [t]he nation's trauma system is the backbone of effec­ tive response to future incidents, if any. there are less than 200 ievell and 2 designated trauma hospitals in the united states. baylor has used alignment of physicians, through specialty hospital and ambulatory surgery center joint ventures, and other forms of effective alignment, to keep physicians engaged in the trauma system. 33 the aforementioned scenario demonstrates that joint ventures present a viable model that impacts health care on many levels. joint ventures ensure that physicians have an opportunity to fully engage in every aspect of providing and managing care, particularly in specialty areas that are critical to protecting the well-being and health of entire communities. til. legal considerations of joint ventures in addition to reimbursement considerations, there are many laws and 33 competitive effects of specialty hospitals, supra note 26, at 5-6 (statement of john t. thomas, senior vice president, general counsel, baylor health care system). 250 indiana health law review [vol. 4:239 regulations that govern joint ventures. for purposes of this article, the most significant laws are the federal anti-kickback laws, the physician self-referral law, and the civil monetary penalty provisions. in addition, there are signifi­ cant tax issues related to a hospital's exempt status that must also be examined. these laws and tax implications often apply at both the federal and state level and have the potential for creating both civil and criminal penalties if violated. a. starklaw the physician self-referral law (hereinafter "stark") prohibits physi­ cians or family members who have a financial relationship with a health care entity from referring medicare or medicaid patients to that entity for the provi­ sion of certain designated health services ("dhs'') unless the arrangement fits within one of the specifically enumerated exceptions.34 because dhs include all hospital inpatient and outpatient services,35 it is very likely that an analysis will need to be undertaken to determine whether stark will apply because many of the services that will be provided ''under arrangements," or through some other joint venture model, are either hospital inpatient or outpatient services. services offered on an ''under arrangements" basis or pursuant to the "provider based" rules must satisfy at least one stark exception. because stark is very close to a strict liability law, failure to fully comply with any part of the exception leaves one at risk for various legal liabilities. there are three stark exceptions that are commonly applied to provide protection for joint venture relationships: 1) personal service arrangements; 2) fair market value; and 3) indirect compensation arrangements. 1. personal service arrangements in order for the personal services arrangement exception to apply, the par­ ties must agree to the arrangement prior to formation of the joint venture. the agreement must be memorialized in a signed writing which specifies the ser­ vices that are to be covered?6 additionally, the arrangement's term must be for at least one year and the contract for services may not exceed what would be reasonable or necessary to advance the legitimate business purpose of the ar­ rangement. 37 if the arrangement is terminated prior to the completion of the initial year, the parties are not allowed to enter into the same or a similar ar­ rangement for the remainder of the original one-year term. 38 the compensation for the services provided must be set in advance and be based on fair market 34 see 42 u.s.c. § 1395nn (2000). 35 id. § 1395nn(hx6)(k.). 36 42 c.f.r. § 411.357(d)(i) (2007). 37 id. § 411.357(dxiii). · 38 id. § 411.357(d)(iv). 2007] hospital-physician joint venture relationships 251 value. 39 the services to be provided cannot involve .. the counseling or promo­ tion of a business arrangement or other activity that violates any state or fed­ erallaw.'..w finally, unless the arrangement is a physician incentive plan, the compensation cannot take into account the volume or value of any referral or other business generated.41 2. fair market value the conditions of the fair market value exception to stark are similar to those of the personal service arrangement exception. the fair market value ex­ ception applies to any physician or group of physicians arranging to provide items or services to the entity.42 the arrangement between these parties must be documented in a writing, signed by the parties, and be intended to cover only identifiable items or services. 43 unlike the personal service arrangement excep­ tion, the fair market value exception dictates no set period of time as the mini­ mum required contract duration and permits the inclusion of a termination clause.44 the fair market value exception applies so long as only one arrange­ ment for the same or similar services is entered into during the course of one year.45 any arrangement that is for less than one year may, however, be re­ newed repeatedly and without limitation, provided the terms and compensation remain the same. 46 like the personal service arrangement exception, the com­ pensation must be set in advance, must be consistent with fair market value, and cannot be determined by reference to the volume or value of the referrals.47 lastly, the arrangement must be commercially reasonable, further the legitimate purpose of the business, and not violate anti-kickback or any other fed­ eral or state laws.48 3. indirect compensation arrangements the third applicable exception, an indirect compensation arrangement, contains requirements similar to those of the previous two exceptions. for ex­ ample, if physicians owned the management company that provided services to the hospital, then an "indirect compensation arrangement" exception might be the applicable stark exception. the indirect compensation received by the re39 /d. § 411.357(d)(v). 40 id § 411.357(dxvi). 41 id. § 411.357(d)(vix2). 42 id. § 411.357(ix1). 43 id. § 411.357(ix1). 44 id. § 4ll.357(ix2). 45 jd. § 411.357(1)(2). 46 ld § 411.357(1)(2). 47 ld § 411.357(1)(3). 48 id § 411.357(ix4)-(5). 252 indiana health law review [vol. 4:239 ferring physician must be at fair market value for services actually provided and cannot take into account the volume or value of referrals.49 in addition, the ar­ rangement must be set out in writing, signed by the parties, and specify the ser­ vices covered by the arrangement. 50 an exception applies in the case of a bona fide employment relationship between an employer and an employee, which does not require the arrangement to be set out in a written contract. 51 in the case of a bona fide employment relationship, however, the arrangement "must be for identifiable services and be commercially reasonable even if no referrals are made to the employer."52 finally, the arrangement must not violate anti­ kickback or any federal or state laws. 53 b. anti-kickback the anti-kickback provisions of the medicare and medicaid fraud and abuse laws state that an individual will be guilty of a felony if he "knowingly and willfully solicits or receives any remuneration ... directly or indirectly ... in return for referring an individual" for the furnishing or arranging of any item or service for which payment may be made under medicare or medicaid. 54 unlike stark which imposes strict liability, in order to violate the anti­ kickback statute, there must be both some remuneration offered, paid, solicited, or received and some "illegal intent" on the part of the parties to induce refer­ rals of medicare or medicaid. 55 because the anti-kickback statute is not a strict liability statute, full compliance with an anti-kickback safe harbor provi­ sion is not required. however, the payment for services in an "under arrange­ ments" or other joint venture relationship will constitute "remuneration" under the anti-kickback statute, and therefore, it is essential that none of the partici­ pants in the joint venture have an illegal intent to induce referrals. if this illegal intent is present, the parties must not proceed with the formation of the joint venture. even if no illegal intent is present, however, a judge or jury could er­ roneously conclude that the requisite "illegal intent" is present. risk related to anti-kickback can never be completely eliminated without fully complying with a safe harbor, making it desirable to have the contract structured so that it complies with a safe harbor. one such safe harbor that could apply to a joint venture is the investment interest safe harbor. this safe harbor is broken down into three parts depend­ ing on the size of the entity and the amount of control possessed by the inves49 !d. § 411.357(p)(l). so /d. § 411.357(p)(2). 51 fd. § 411.357(p)(2). 52 id § 411.357(p)(2). 53 id § 411.357(p)(3). 54 social security act, 42 u.s.c. § 1320a-7b(b )( 1) (2000). 55 see id § 1320a-7b(b). 2007] hospital-physician joint venture relationships 253 tors. 56 the three categories, however, exclude from the definition of remunera­ tion "any payment that is a return on an investment interest, such as a dividend or interest income, made to an investor as long as" the standards within that category are met. 57 in addition, four other safe harbors or exceptions could ap­ ply to a joint venture of this kind. 1. space rental the space rental safe harbor excludes from the term "remuneration" any payments made by a lessee to a lessor for the use of property as long as certain standards are met. 58 these standards include the requirement that the lease agreement be set out in writing, specify the premises covered by the lease, and be signed by the parties. 59 if the lease provides access for only intervals of time and not on a full-time basis, it must specify ''the schedule of the intervals, their precise length, and the exact rent for such intervals. ·.60 the lease term must last for at least one year, and the rental charge for the premises must be set in ad­ vance, must be consistent with fair market value, and must not take into account the volume or value of any referrals.61 2. equipment rental as long as the same standards that were required for the space rental safe harbor are met, this safe harbor excludes from the definition of remuneration any payments made by a lessee of equipment to the lessor of the equipment for the use of the equipment. 62 3. personal services and management contracts exception this safe harbor excludes from the definition of remuneration "any pay­ ment made by a principal to an agent as compensation for the services of the agent" if certain standards are met. 63 these standards are very similar to the space rental and equipment rental safe harbors except that they also require that the services performed not promote a business arrangement that violates federal or state law and are not in excess of what would be reasonably necessary to ac­ complish the business purpose.64 56 see 42 c.f.r. §1001.952(a) (2006). 57 id. 58 id. § 1001.952(b). 59 id. § 1001.952(b)(l)-(2). 60 id. § 1001.952(b)(3). 61 id. § 1001.952(b)(4)-(5). 62 id. § 1001.952(c). 63 id. § 1001.952(d). 64 id. § 100l.952(d)(6)-(7). 254 indiana health law review [vol. 4:239 4. per-click arrangements since a "per-click" or "per-patient" compensation method is not consid­ ered "volume or value" based compensation under stark, payment on a "per­ click" basis is expressly permitted. regardless ofthis fact, however, the office of inspector general ("oig") has issued two statements on "per-click" ar­ rangements that indicate a more skeptical view.65 in a 2003 advisory opinion, an unidentified company proposed to develop and manage inpatient rehabilita­ tion units within general acute care hospitals pursuant to certain management agreements.66 the compensation was to be a monthly management fee calcu­ lated on a per patient, per day basis. 67 the oig responded unfavorably by stat­ ing that a payment structure such as this is "disfavored" under the anti­ kickback statute.68 similarly, the commentary of the anti-kickback final rule includes a discussion clarifying the use of a "per-use" or "per-order" payment arrangement.69 the oig questioned this method because of its relationship to volume of business or amount of revenue, which would result in an incentive to refer. however, the oig did not declare it a per se violation of the anti­ kickback statute, instead stating that the "more the payments appear to reflect the volume of referrals from a financially interested party, the more suspect the arrangement becomes," and that will result in a more thorough analysis by the oig.70 a "per-click" method falls within a gray area of the anti-kickback stat­ ute. though the use of a "per-click" may not be a per se violation of the anti­ kickback statute, using this type of agreement will result in the arrangement not complying with the requirements of a safe harbor. therefore, in order to mini­ mize the risk of a violation, hospitals must look to satisfy as many of the safe harbor's elements as possible. in addition, the parties should establish anum­ ber of"good facts" to support the use of"per-click" compensation and to dem­ onstrate that the hospital and physicians have a lawful motive. some "good facts" might include that the venture raises needed capital to improve services, shares evenly the risk inherent in developing a new delivery model, or results in the pooling of diverse expertise to benefit the overall quality and efficiency of the service provided. 65 see 3 op. off. inspector gen. 8 (apr. 3, 2003), available at http://oig.hhs.gov/fraud/docs/advisoryopinions/2003/ao0308.pdf[hereinafter op. off. inspector gen.]. see also medicare and state health care programs: fraud and abuse; oig anti­ kickback provisions, 42 c.f.r. pt. 1001 (2007), available at http://oig.hhs.gov/fraudldocs/safeharborregulations/07299l.htm [hereinafter oig anti-kickback provisions]. 66 op. off. inspector gen., supra note 65. 67 id. 68 id. at 5. 69 oig anti-kickback provisions, supra note 65. 7o id. 2007] hospital-physician joint venture relationsidps 255 c. hospital's tax-exempt status there are significant tax issues that may affect the exempt status of a tax­ exempt hospital that enters into an "under arrangements" or other joint venture relationship. 1. private inurement and private benefit prohibitions a tax-exempt entity must ensure that the community, not any individual, receives the benefits of its tax-exempt statutes. failure to do. so can lead to the revocation of the hospital's exempt status. to mitigate these risks, all dealings between the tax-exempt hospital and physicians must be at fair market value and commercially reasonable. 2. sale of revenue stream arrangements care must be taken to ensure that the joint venture relationship does not result in the sale of a "revenue stream" as described in general counsel memo­ randum 39862.71 this memorandum issued by the irs states that a tax-exempt entity cannot sell its revenue stream. 72 these arrangements are considered to violate the private inurement and private benefits prohibition noted above. a critical element of the joint venture relationship must be that the physicians, directly or indirectly (e.g., through ownership in a management company), are providing bona fide services. this is critical to establish that the arrangement is not the "sale" of a revenue stream but rather a contract for the hospital to pur­ chase bona fide services, at fair market value, from the physicians. 3. use of bond financed property-revenue procedure if operations are to be undertaken in a space (or with equipment) that was built or purchased with proceeds derived from tax-exempt financing (e.g., tax exempt bonds), then the operations must be structured to avoid converting the use of that space (or equipment) to "private use.'m revenue procedure 97-13 provides a safe harbor that should be met unless the financed space and/or equipment falls within the "de minimus" amount of private business use that is permitted.74 if there is excess private use, then the interest income that is paid to bond holders may be subject to taxation as income. 75 71 i.r.s. gen. couns. mem. 39,862 (nov. 22, 1991). 72 id. 73 26 u.s.c. § 145(a) (2000). 74 rev. proc. 97-13, 1997-1 c.b. 633. 15 ld. 256 indiana health law review [vol. 4:239 4. unrelated business income the extent and consequences of potential unrelated business income should be considered. similarly, the potential impact of the joint venture on the hospital's tax-exempt status (e.g., rev. rul. 98-15) must be considered.76 5. fair market value opinion a credible third-party opinion is important to help prove the arrangement is at fair market value and commercially reasonable. in order to comply with the requirements of the anti-kickback statute, the stark law, and tax code, it is necessary to establish that the arrangement will result in payment, directly or indirectly, at fair market value. d. civil monetary penalty a hospital cannot make payments directly or indirectly to a physician as an inducement for reducing or limiting services. 77 this reflects the statute im­ plicated in the "gainsharing" arrangement on which the office of inspector general opined in 2006.78 any joint venture relationship that involves manag­ ing supplies of staff or other goods or services provided to medicare and medi­ caid patients must be structured so that the hospital is not paying money as an inducement to the physicians to reduce services. iv. operational and quality efficiency incentives for use in billing "under arrangement" relationships despite the number oflegal considerations that one must understand and navigate when structuring the joint venture relationship, there are many other incentive options that can be used to improve the quality, efficiency, and safety of the venture. these incentive options fall under two broad categories: opera­ tional efficiency incentive compensation and quality of services incentive compensation. as the names suggest, the former category involves behind-the­ scenes aspects of the venture, which include the utilization of the materials and equipment of the venture, scheduling of patients, and processes for keeping the venture running at its optimal state. the latter category deals with incentivizing the service aspect of the venture, which helps to provide the patient with a safe, enjoyable, and comfortable experience. below are a number of incentives that 76 rev. rul. 98-15, 1998-121.r.b. 6. 77 42 u.s.c. § 1320a-7a(b) (2000). 78 6 op. off. inspector gen. 2 (nov. 16, 2006), available at http:/ /oig.hhs.gov/fraud/docs/advisoryopinions/2006/ adv0pn06-22newa.pdf(referring to rule 14.4). 2007] hospital-physician joint venture relationships 257 can be implemented to improve safety, quality, and efficiency within a joint venture relationship. a. operational efficiency incentive compensation 1. inventory turns first, keeping inventory to minimum levels will have a positive effect on the cost, and in some cases, the quality, of the care provided. second, this in­ centive, through managed care negotiations and other market forces, is ex­ pected to improve the operation of the "central supply" function of a hospital, reduce operating costs, and produce savings that will benefit consumers. fi­ nally, this incentive will promote utilization of the latest in technology and equipment. it has been established that there is a linear relationship between efficient levels of inventory and volume. therefore, this metric will not be more easily achieved with greater volume. rather, achieving this metric will depend solely on efficient inventory management. the levels of inventory are designed to promote efficient inventory utilization, and therefore, safeguards may be necessary to protect against inappropriately low levels of inventory. payments could be made as follows: 79 ran2efioor ran2e ceiling payment 0 inventory turns < 8 inventory turns $0(%) 8 inventory turns <1 0 inventory turns $x (33%) 10 inventory turns <12 inventory turns $x+(66%) 12 inventory turns 00 $x++(100%) 2. first case on-time start this incentive promotes physician and patient satisfaction because it cre­ ates an environment where surgery schedules are more predictable. in addition, it should reduce operating costs (e.g., less overtime) by producing savings that could benefit patients and other consumers through managed care negotiations and other market forces. a patient case is considered to be started "on time" if the procedure begins no later than an agreed upon number of minutes after the scheduled start time. this metric is unaffected by volume of work. in the al­ ternative, payments could be based upon a percentage increase in on-time starts. payments can be made as follows based on the percentage of .first cases of the day being on time or based on the starts of each case throughout the day: 79 please note that the tables included in this article are merely examples and do not necessarily reflect the way in which a specific arrangement will be structured; the xs indicate a field where an appropriate compensation amount would be inserted, depending on the fact­ specific situation. 258 indiana health law review [vol. 4:239 range floor range ceilin2 payment 0% of cases < 60% of cases $0(0%) 60.1% of cases < 75% of cases $x(33%) 75.1% of cases < 90% of cases $x+(66%) 90.1% of cases 100% $x++(100%) 3. room turnaround time this incentive should reduce operating costs and produce savings that could benefit consumers through managed care negotiations and other market forces. in addition, the incentive will help to increase volume and lower cost per case. the incentive can be measured from the completion of a procedure to the commencement of the next procedure, which does not take into account the volume or value of work. appropriate benchmarks should be determined based on literature or other appropriate means, so as not to encourage inappropriate or excessive expense cutting. payments can be made based on the average room turnaround time: ran~r:efloor ranke ceilink payment > 30minutes none $0(0%) >25 minutes 30minutes $x(33%) >20minutes 25 minutes $x+(66%) none less than 20 minutes $x++ (too%) 4. utilization of block schedule ifblock scheduling is utilized at the hospital or other surgery facility, then incentives can be implemented to ensure that the time is fully utilized and that the operating rooms are not idle while fully staffed. block scheduling utiliza­ tion measures how effectively physicians are using scheduled procedure rooms. an incentive plan based on the effectiveness of a physician • s utilization of fa­ cilities and resources could be structured as follows: ran~r:efloor ranee ceilina incentive 0% utilization < 55.0% utilization $0(0%) 55.1% utilization 57.5% utilization $x (33%) 57.6% utilization 60.0% utilization $x+(66%) > 60.0% utilization 100% utilization $x++(l00%) for example, a four-hour time block scheduled in a procedure room has 240 minutes of capacity. if a physician uses 200 minutes of the block time, the utilization percentage is 83%. if the amount of the incentive or compensation is one-hundred dollars ($1 0().00), for example, then according to the chart, the 2007] hospital-physician joint venture relationships 259 physician would receive 1000/o of that amount, or $100.00, because he or she achieved a utilization percentage of more than 60%. 5. patient discharge incentives based upon the percentage of patients that are discharged be­ tween specified time periods are also possible and will improve the efficiency of the patient discharge process. b. quality of services incentive compensation 1. core measures for acute myocardial infarctions the hospital will work with the physicians (e.g., cardiplogists) to establish measures and appropriate levels of compliance with those measures (e.g., giv­ ing aspirin or beta blockers on arrival or on discharge). the use of this incen­ tive would not take into account the volume or value of the work and should enhance the quality of the services performed. in addition, the data gathered can be used to prove quality and further develop best practices. 2. congestive heart failure core measures the hospital will work with the physicians (e.g., cardiologists) to establish quality measures and appropriate levels of compliance to ensure that the hospi­ tal is within the top decile on the national voluntary hospital reporting initia­ tives for congestive heart failure ("chf'') core measures (e.g., discharge instructions and smoking cessation). the use of the core measures will be used to enhance the quality of the services performed as well as to develop reliable data to prove the quality of the services. in addition to the chf core meas­ ures, other objective, measurable quality criteria are available from organiza­ tions such as leap frog and the centers for medicare and medicaid services. 3. patient satisfaction one incentive method that can be used to improve the quality of services provided is to measure and pay incentives to achieve a certain level of patient satisfaction. the incentive would be structured in a way that the joint venture would be required to meet a certain level of patient satisfaction in order to re­ ceive compensation. patient satisfaction could be measured by routine surveys showing patients' "overall satisfaction" with their hospital experience, adminis­ tered by the hospital or a third-party. for example, if a certain percentage (e.g., greater than 95%) of the patients rated their experience "good" or "very good," the contracted individuals would receive an agreed upon payment as compensa­ tion. if the patients rated it lower (e.g., 90.1%-95% ), then the compensation would be lower and so on until there would be no compensation provided. 260 indiana health law review [vol. 4:239 4. associate and physician satisfaction employees and physicians who are satisfied and comfortable in their posi­ tions provide more accurate and efficient assistance to the joint venture. one method of measuring and improving employee and physician satisfaction is through incentives based on the level of satisfaction. if the joint venture efforts result in high levels of employee satisfaction, then it would be entitled to the incentives indicated for that level of satisfaction. routine satisfaction surveys, retention levels, or comments could measure the level of satisfaction. 5. time out/universal protocol compliance this option is used to provide an incentive to attain a minimum compli­ ance level (e.g., greater than 95% or another percent depending on historical data) with respect to the joint commission's "universal protocol for prevent­ ing wrong site, wrong procedure, wrong person surgery.'.so compliance with the joint commission's time out/universal protocol compliance of greater than 95%, but less than 100%, would entitle the physicians to the payment as an incentive. the standards could be as follows: compuance range floor percent of incentive pool avauable <95% 0% 95%to95.9% 75% 96% to 96.90/o 80% 97%to97.9% 85% 98%to98.9% 90% 99% to 99.90/o 95% 100% 100% 6. other outcome measures alternative outcome measures of the quality of services could include counting the number of infections ( detennined from medical record review), re­ do operations (determined from medical record review), or accuracy of instru­ ment sets (determined by incident reports). each outcome measure would re­ quire an appropriate benchmark to be detennined based on industry literature or 80 the joint commission, universal protocol for preventing wrong site, wrong proce­ dure, wrong person surgery, http:/lwww.jointcommission.org/patientsafety/universalprotocol (last visited oct. 14, 2007). 2007] hospital-physician joint venture relationships 261 other appropriate means. these alternative outcome measures will seek to im­ prove safety, quality, and efficiency. v. conclusion the use of operational and quality efficiency incentives in joint ventures between hospitals and physicians are tools that can help a hospital provide bet­ ter overall health care to the community. among other things, joint ventures provide access to capital, help keep services available to the community, and provide better supervision and control over employees within the hospital. in addition, joint ventures provide physicians with management responsibilities that will improve the overall operation of a hospital. in turn, this will enhance the quality of services performed, control costs, increase efficiency, and provide benefits to many other areas of the hospital as well. the legal restrictions that apply to joint venture arrangements of this type will require significant planning and preparation, but as some of the provided incentives demonstrate, compen­ sation arrangements can be established that will result in a mutually beneficial relationship. for this reason, hospitals and physicians can find a common ground with joint venture relationships. through hospital and physician col­ laboration, patients will receive care that is more convenient and safe, the pub­ lic will see benefits to the communities, the physicians will have more influence or control over their work environment (and achieve some measure of :financial security), and hospitals will increase their ability to provide the best possible care. john b. mitchell raised in the midwest, professor mitchell moved to the west coast to attend stanford law school, where he was a member of the moot court board and editor of the law review. he earned his j.d. at stanford in 1970. professor mitchell's wide ranging career has included: private practice in his own law finn in san francisco, where he specialized in criminal litigation (1970-75); consultant to public and private defense attorneys concerning trial, motions and appellate strategies (1973-1982); and director oflegal training for the seattle office of perkins coie where, while away from the law school, he developed a two-year training curriculum for new associates in business and litigation (1988-90). professor mitchell is co-author (with professor marilyn berger) of two little, brown & co. textbooks on trial advocacy: pretrial advocacy: planning, analysis and strategy (1988) and trial advo­ cacy: planning analysis and strategy (1989). he has written exten­ sively for professional journals on such topics as professional responsibility, learning and educational theory, training oflawyers, constitutional law, legal process, and criminal procedure. over the past two decades, professor mitchell has taught courses in evidence, forensics, criminal law, criminal procedure and advocacy. he was also a member of the law practice clinic for six years, the last two as directory. my father, john locke, and assisted suicide: the real constitutional right john b. mitchell• my father was diagnosed with pancreatic cancer in early summer of 1995. with the help of a hospice, 1 we brought him home for the last several weeks of his life. six weeks later, he was dead. he was seventy·nine years old. dad had been in incredible pain, even with the morphine drip which the hospice had to increase at least once a day. during this time, my father asked my sister and me to help him die. just take him to the garage, rig a hose from the exhaust, and run the car. let it end. we wouldn't do it; probably out of a mix of some sense that it would be wrong, concern that we would bumble it, and fear of getting caught the next year, two federal appellate courts--the ninth circuit, relying on a fundamental rights analysis, 2 and the second circuit/ invoking equal protection-would find it unconstitutional to deny a terminally ill, suffering patient access to assisted suicide.4 it would only be another year before the united states supreme court would reverse both appellate decisions in nine. zero opinions; the ninth circuit court's opinion, in washington v. glucksberg,5 and the second circuit's opinion in vacco v. qui/1.6 an out· pouring of scholarship followed the appellate, 7 and then the supreme court • professor oflaw, seattle university school oflaw, j.d., stanford law school. the author wishes to thank annette clark for her knowledge, penetrating questions and insights, bob menanteaux, librarian extraordinaire, for all his help, and phyllis brazier who was left to struggle with endless misnumbered foo1notes and yet never lost her sense ofhumor. i also want to thank dean kellye testy and seattle university school of law for a grant supporting my research. 1. hospice provides "comfort care" or ''palliative care"; i.e., it is treatment focused on relieving physical, emotional and spiritual pain rather than achieving a cure. see, e.g., cicely m. saunders, the philosophy ofterminal care, in the management of terminal disease 193 (cicely m. saunders ed., 1978). in filet, medicare only pays for hospice if the patient stops all curative treatments. see public health, 42 c.f.r. § 418.24 (2005). 2. compassion in dying v. washington, 79 f.3d 790 (9th cir. 1996) (en bane), rev'd remanded, washington v. g1ucksberg, 521 u.s. 702 (1997). 3. quill v. vacco, 80 f.3d 716 (2d cir. 1996), rev'd, vacco v. quill, 521 u.s. 793 (1997). 4. see glucksberg, 521 u.s. at 708-709 (asserting right claimed was for ''mentally competent, terminally ill adultsj. 5. id. 6. vacco v. quill, 521 u.s. 793 (1997). 7. see, e.g.,martinflumenbaum& brads. karp, the right todie,2n.y.l.j. 3 (1996) (discussing vacco v. quill); susan r. martyn & henry j. bourguignon. physician assisted suicide: the fatal flaws in the ninth and second circuit decisions, 85 cal. l. rev. 371 (1997); margaret p. miller, boot-strapping down a slippery slope in the second and ninth circuits: compassion in dying is neuher compassionate nor constitutional, 30 creighi'on 46 indiana health law review (vol. 3:43 opinions.8 some commentators applauded the supreme court l. rev. 833 ( 1997); michaels. popkin, symposium, physician-assisted suicide: legal rights in life and death, 12 st. john's j. legal comment 701 (1997) (predicting how supreme court will rule on second and ninth circuit decisions). 8. see kim c. arestad, v acco v. quill and the debate over physician assisted suicide: is the right to die protected by the fourteenth amendment?, 15 n. y.l. sch. j.hum. rts. 511 (1999); howard brody, physician-assisted suicide in the courts: moral equivalence, double effect, and clinical practice, 82 minn. l. rev. 939 (1998); reginal bussey,physician-assisted suicide: the hippocratic dilemma, 22 t. marshalll. rev. 253 (1997); erwin chemerinsk:y, a right to physician assisted suicide?, 33 trial 68 (1997); steven b. datlof, beyond washington v. glucksberg: oregon's death with dignity act analyzed from medical and constitutional perspectives, 14 j .l. &health 23 (1999-2000) (predicting how supreme court will rule on second circuit and ninth circuit decisions); ezekiel j. emanuel, the future of euthanasia and physician-assisted suicide: beyond rights talk to informed public policy, 82 minn. l. rev. 983 (1998); david m. english, supreme court upholds state statutes barring physician-assisted suicide, 24 est. plan. 392 ( 1997) (may 1998); brett feinberg, the court upholds a state law prohibiting physician-assisted suicide, 88 j. crim. l. & crimonology 847 (1998); scott fitzgibbon, the failure of freedom-based and utilitarian arguments for assisted suicide, 42 am. j. juris. 211 (1997); clarke d. forsythe, the incentives and disincentives created by legalizing physician-assisted suicide, 12 st. john's j. legal comment 680 (1997); leon friedman, physician-assisted suicide, 14 touro l. rev. 415 (1998); lawrence 0. gostin, liberty interest in aided suicide rejected: court finds no constitutionally protected interest, distinguishing the withdrawal of life support, 19 nat'l l.j., aug. 8, 1997 at b9; robert m. hardaway, miranda k. peterson & cassandra mann, the right to die and the ninth amendment: compassion and dying after glucksberg and vacco, 7 geo. mason l. rev. 313 (1999); michael b. hickey, reading the mystery passage narrowly: a legal, ethical and practical argument against physician-assisted suicide, 12 notredamej.l. ethics&pub. pol'y 567 (1998); yale kamisar, on the meaning and impact of the physician-assisted suicide cases, 82 minn. l. rev. 895 (1998) [hereinafter kamisar, meaning and impact]; yale kamisar, the future of physician-assisted suicide, 34 trial 48 ( 1998) [hereinafter kamisar, future of physician-assisted suicide]; patricia a. king & leslie e. wolf, empowering and protecting patients: lessons for physician-assisted suicide from the african-american experience, 82 minn. l. rev. 1015 ( 1998); rachel d. kleinberg & toshiro m. mochizuki, recent developments: the final freedom: maintainingautonomyand valuing life in physician-assisted suicide cases, 32 har.v.c.r.c.l. l. rev. 197 (1997); russell korobkin, physician-assisted suicide legislation: issues and preliminary responses, 12 notre dame j.l. ethics & pub. pol'y 449 (1998); seth f. kreimer, the second time as tragedy: the assisted suicide cases and the heritage ofroe v. wade, 24 hastings const. l. q. 863 ( 1998); sylvia a. law, birth and death: doctor control v. patient choice, 82 minn. l. rev. 1045 ( 1998); nelson lund, two precipices, one chasm: the economics ofphysician-assisted suicide and euthanasia, 24 hastings const. l.q. 903 (1997); frederick r. parker, jr., washington v. glucksberg andvacco v. quill: an analysis of the amicus curiae briefs and the supreme court's majority and concurring opinions, 43 st. louis u. l.j. 469 ( 1999); jennifer cole popick, a time to die?: deciding the legality of physician-assisted suicide, 24 pepp. l. rev. 1325 (1997); popkin, supra, note 7; john h. robinson, physician-assisted suicide: a constitutional crisis resolved, 12 notre dame j. l. ethics & pub. pol'y 369 ( 1998); john p. safranek & steven j. safranek, can the right to autonomy be resuscitated after glucksburg?, 69 u. cow. l. rev. 731 ( 1998); vincent j. samar, is the the right to die dead?, 50 depaul l. rev. 221 (2000); louis shepherd, dignity and autonomy after washington v. glucksberg: an essay about abortion, death, and crime, 7 cornellj. law &pub. pol'y 431· (1998); kathryn l. tucker, the death with dignity movement: protecting rights and expanding options after glucksberg and quill, 82 minn. l. rev. 923 (1998); melvin i. urofsk:y, leaving the door ajar: the supreme court and assisted suicide, 32 u. rich. l. rev. 313 (1998); susan m. wolf, pragmatism in the faceofdeath: the role of facts in the assisted 2006] my father, john locke and assisted suicide 47 decisions,9 for what they interpreted as reining in what they saw as a trend toward fundamental rights creation.10 some criticized the opinions. 11 some approved the legislative path onto which the court had steered the assisted suicide debate, 12 while others expressed great concern over a legislative resolution.13 there were also those who believed that the cases ended any realistic possibility of locating a right to assisted suicide in the constitution because, in their view, the court had explicitly rejected all the arguments suicide debate, 82 minn. l. rev. 1063 (1998); see also, jennifer bradford, v acco v. quill and washington v. glucksberg: thou shall not kill, unless your state permits physician-assisted suicide, 26 pepp. l. rev. 121 (1998); katherine c. glynn, turning to state legislatures to legalize physician-assisted suicide for seriously ill, non-terminal patients after vacco v. quill and washington v. glucksberg, 6 j. law & pol'y. 329 (1997); philip king, washington v. glucksberg: influence of the court in the care of the terminally ill and physician-assisted suicide, 15 j. l. & healm 271 (2000-2001 ); david lavalle, note, physician-assisted suicide: is there a right to die?, 31 suffolk u. l. rev. 945 (1998); miller, supra note 7; larry i. palmer, essay, institutional analjsis and physician's rights after v acco v. quill, 7 cornell j. l. & pus. pol'y 415 (1998); gina d. patterson, the supreme court passes the torch on physician assisted suicide: washington v. glucksberg and vacca v. quill, 35 hous. l. rev. 851 (1998); ursula a. petrozzi, note, the forgotten lessons in quill v. vacco: a perspective on the modern judicial role as the calabresian remedy to the problem of statutory obsolescence, 44 wa ynb l. rev. 343 (1998); nicole testa, sentenced to life? an analysis of the united states supreme court's decision in washington v. glucksberg, 22 nova l. rev. 821 (1998); see also martin flumenbaum & brad s. karp, second circuit review-reversals in 1996 supreme court term, 215 n.y.l.j. 3 (oct. 3,1997); daniel wise, an attempt to make death meaningful, 215 n.y.l.j. 1 (apr. 4, 1996). 9. see jobn h. garvey, control freaks, 47 drake l. rev. 1 (1998); kamisar, future of physician-assisted suicide, supra note 8, at 975; john keown, no constitutional right to physician-assisted suicide?, 56 cambridge l.j. 506 (1997); lavalle, supra note 8, at 975; jill a. me1choir, the quiet battle for the heart ofliberty-a v'u:tory for the cautious: washington v. g1ucksberg, 117 s.ct. 2258(1997), 66u.cin.l.rev. l359(1998);ewicepark,physician­ assisted suicide: state legislation teetering at the pinnacle of a slippery slope, 7 wm. & mary bd..lrts. j. 227, 3q3 (1998); robinson, supra note 8; wol( supra note 8. 10. see james bopp, jr. & richard e. coleson, three strikes: is an assisted suicide right oun, 15 issues in l. & med. i, 9-10 (1999); lund, supra note 8, at 903; michael w. mcconnell, the right to die and the jurisprudence oftradition, 1997 utahl. rev. 665, 681 (1997); melchoir, supra note 9, at 1359; robinson, supra note 8, at 369. 11. see feinberg, supra note 8, at 847 (,l]he supreme court incoitectly concluded that the right to die with assistance is a not a fundamental right." (footnote omitted)); gostin, supra note 8, at 869; kreimer, supra note 8, at 869, 871; patterson, supra note 8, at 880; safranek & safranek,· supra note 8, at 756 ("if hermeneutic inquiries into the constitutional limits of autonomy and liberty are actually governed by moral theoryrather than legal principle then the judiciary imposes a view of the good whenever it mediates important personal rights' disputes. j; steven staihar, the state's unqualified interest in preserving life: a critique of the formulation of life's sanctity in washington v. glucksberg, 341daho l.rev. 401,421 (1998); testa, supra note 8, at 852 (noting that certain state interests are inadequate to prevail over liberty interest). 12. see emanuel, supra note 8, at 983; glynn, supra note 8, at 338; park, supra note 9, at 277. for discussion of issues to be faced by state legislatures considering physician-assisted suicide, see korobkin, supra note 8. 13. see kelly lyn mitchell, physician-assisted suicide: a survey of the issues surrounding legalization, 14 notre damel. rev. 341, 374-375; park, supra note 9, at 277. 48 indiana health law review [vol. 3:43 supporting a right to assisted suicide.14 on the other hand, there were others who saw the constitutional door as still open. 15 and then within a couple of years, the articles ceased and legal scholars and law review editors turned to new academic pastures.·. i did not stop pondering the issue. my father's death and my refusal to help him die continued to haunt me. the more i thought, the more i felt that 14. see kamisar, meaning and impact, supra note 8, at901 (recognizing that the supreme court rejected all the arguments underlying the claim for a right to assisted suicide); kamisar, future of physician-assisted suicide, supra note 8; of some note is the fact that following g/ucksberg, the florida supreme court rejected an analogous claim under the privacy section of the florida state constitution in kirkscher v. mciver, 697 so. 2d 97, 104 (fla. 1997). thus, the florida court rejected the claim based on independent state constitutional grounds. regarding independent state grounds; see generally, michigan v. long, 463 u.s. 1032, 1059 (1983); lawrence h. tribe, american consti1utionallaw 164-166 (2d ed. 1988). 15. see chemerinsky, supra note 8, at 69 (arguing that there may be constitutional right in speeific case); samar, supra note 8, at 221 (contending that the right to die still a viable constitutional argument because of the "level of abstraction" relied upon by the court); tucker, supra note 8, at 935. ·. some of the basis for contentions that glucksberg and vacco did not foreclos!o' future constitutional claims is based on the fact that the cases involved "facial challenges" to the statutes, rather than an "as applied" challenge which would focus on the poignant facts of a particular case.· see samar, supra note 8, at 309; urofsky, supra note 8, at 398. additionally, five justices in g/ucksberg intimated that at some point a patient would possess a fundamental constitutional right to be allowed access to. the means to control excruciating pain. glucksberg, 521 u.s. at 737 (o'connor, j.), 742 (stevens, j.), 789 (ginsberg, j.), 790 (breyer, j.), 791 (souter, j. ); see chemerinsky, supra note 8, at 69 ("five justices, in concurring opinions and opinions concurring in the judgment, left open the possibility that laws prohibiting physician­ assisted suicide might be declared unconstitutional in specific cases."). while the source of possible rights hinted at within these five opinions was substantive due process, another author has suggested that a similar route could be accessed through the eighth amendment: there may be some novelty in suggesting that the state is constitutionally barred not only from directly imposing severe pain, but also from preventing the alleviation of physical suffering caused by other forces. but estelle, two decades ago, concluded that deliberate indifference to serious medical needs of prisoners can impose constitutionally impermissible "wanton and unnecessary pain." indeed, one of the examples cited by the court in &telle as "cruel and unusual punishment" was refusal to administer a prescribed pain killer to prisoners after surgery. kreimer, supra note 8, at 893.(citatitm omitted). whatever the source of the constitutional underpinning, the five justices did not seem to be considering an individual terminal patient whose suffering is so great that they should be permitted to end his life rather than be forced to continue suffering. in fact, any such suffering, terminally ill patient-like all the plaintiffs in gluclrsberg and v acco-likelywould be dead by the time the court heard their case. mcconnell, supra note 10, at 674. rather, the justices' thoughts were upon state legislation that precluded access to adequate pain control, e.g., by making actions conducted under the principle of double effect (where a doctor gives pain medication with the intent of relieving pain, but with knowledge of a risk that the pain medication could kill the patient) illegal. see chemerinsky, supra note 8, at 69; kreimer, supra note 8, at 898 (finding that "(t]he opinions clearly contemplate potential judicial review where legislation or regulations to prohibit physicians :from administering doses of pain medication necessary to avoid terminal suffering. but it is far :from clear that such legislation or regulations in fact exist" (citation omitted)). 2006] my father, john locke and assisted suicide 49 the law had no right to tell my seventy-nine-year-old father that he must lie in bed, suffering in the face of certain and imminent death.. i d,o not think my feelings had anything to do with the sense that my father was being treated unfairly in comparison to other suffering, dying patie~ts who, unlike him, just happened to be on life support machines which they could request to be turned off. nor did i think in terms of some fundamental right to end one's life. my feelings could have been grounded in some right to be free from uncontrollable pain; but what i felt was even more basic and fundamental. my father had done enough. he did not owe anymore to this country. he had a right to be left alone and end his life if he wished. that feeling guided me to a right which is not derived from anything explicit or implied in any textual provision of the constitution. it is a right derived from the two underlying political philosophies16 which form the basis of the entire u.s. constitutional enterprise: john locke's social contract17 and civic republicanism. 18 in part i, this article discusses glucksberg's fundamental rights analysis. so much has been written about this case that this article will limit comments to briefly adding thoughts as to why, given the combination of the court's motivation, both institutional and pragmatic, in approaching this case, and its methodology for analyzing fundamental rights, a nine to zero decision was fairly predictable, even in this difficult, emotionally compelling case. part ll gives more consideration to the equal protection claim. those entering the debate in vacco v. quill regarding whether there is an equivalence between terminating life support (which the law permits) and assisted suicide (which the law forbids), have done so in a rather conclusory fashion, whether contending for19 or againsf0 equivalence. many entering the debate also have 16. but see neomi rao, a backdoor to policy making: the use of philosophers in the supreme court, 65 u. chi. l. rev. 1371, 1371 (1998) (maintaining that courts should not consider philosophy in making their decision, since that is a backdoor method for infusing legislative type policy analysis into their decisions; rather, courts should limit themselves to "history, precedent, and a recognition of the limits of judicial aurhority"). while i believe ms. rao makes a good point, it is not one that applies to the position asserted in this article. i have not trolled the philosophical landscape for my philosophical theories: they are embedded in the very structure of our government. 17. see john locke, second treatise of government (c.b. mcpherson ed., 1980) ( 1690). locke's "social contract" theory formed the basis of our constitutional structure. see, e.g., james a. gardener, consent, legitimacy and elections: implementing popular sover­ eignty under the lockean constitution, 82 u. pm. l. rev. 189, 197-198 (1990). see also infra part iii.a. 18. see, e.g., frank michelman, laws republic, 91 yale l. rev. 1493 (1988). see also infra part m.c. 19. insupportoftherespondentsin glucksbergand vacco, agroupofrespectedpolitical philosophers filed "the philosophers' brief." brief for ronald dworkin et al. as amici curiae supporting respondents, washington v. gluckberg, 521 u.s. 702 (1997) (no. 96-110) reprinted in physician-assisted suicide: expanding the debate, app. c, at 435 (margaret p. pattin et al. eds., 1998) [hereinafter expanding the debate]; brief for ronald dworkin et al. as amici curiae supporting respondents, vacco v. quill, 521 u.s. 793 (1997) (no. 1858) reprinted in expanding the debate, supra, app. c., at 435. ad~ssing the equal protection 50 indiana health law review [vol. 3:43 failed to explicitly question whether, even if what we condone in end-of-life care cannot be morally distinguished from assisted suicide, there may be meaningful distinctions in policy of which the law may properly take into account. 21 a detailed equal protection analysis of legally accepted medical claim, that there was no rational difference between assisted suicide and terminating life support, the philosophers stated: th[is] argument [that there is a meaningful distinction] is based on a misunderstanding of the pertinent moral principles .... when a competent patient does want to die. the moral situation is obviously different. because then it makes no sense to appeal to the patient's right not to be killed as a reason why an act designed to cause his death is impermissible. from the patient's point of view, there is no morally pertinent difference between a doctor's terminating treatment that keeps him alive, if that is what he wishes, and a doctor's helping him to end his own life by providing lethal pills he may take himself, when ready, if that is what he wishes except that the latter may be quicker and more humane. nor is that a pertinent difference from the doctor's point of view. if and when it is permissible for him to act with death in view, it does not matter which of those two means he and his patient choose. if it is permissible for a doctor deb'berately to withdraw medical treatment in order to allow death to result from a natural process, then it is equally permissible fur him to help his patient hasten his own death more actively, if that is the patient's express wish. expandino the de~te, supra, app. c., at 435. whatever one may think about the correctness of the philosophers' claims regarding moral philosophy, these· claims can hardly carry the day when assessing the product of legislation in which poliey and pragmatics can justify treating morally equivalent actions differently(e.g., driving 54.5 mph versus driving 55.5 mph when setting a 55 mph speed limit). at best. questions concerning moral equivalence is a starting point in the analysis. in fact. some philosophers disagree with the authors of the philosophers' brief regarding their stance on. moral equivalence. see, e.g., brody, supra note 8. 20. the yacco court rejected the claim that there is no rational distinction between assisted suicide and pulling the plug by relying more on conclusory pronouncements than csreful analysis: [w]e think the distinction between assisting suicide and withdrawing life­ sustainingtreatment. a distinction widelyrecognized and endorsed in the medical profession and in our legal traditions, is both important and logical; it is certainly rational .... the distinction comports with fundamental legal principles of causation and intent yacco, 521 u.s. 793, at 800-0l (citation omitted). while, as the analysis in part ii.c will demonstrate, the yacco court probably came to the right conclusion, the issue in front of it was far more sophisticated and complex than the court acknowledged in its boilerplate-type analysis. see, e.g., brody, supra note 8, at 943 ("[t]he degree to which one intends and causes death varies along a spectrum; there is no bright line that separates allowing to die and killings."). 21. law is concerned with social policy and not. necessarily, morality. see, e.g., yale kamisar, the reasons so many people support physician-assisted suicideand why these reasons are not convincing, 12 issues in law & med.i 13, 133-114 (1996) [hereinafter kamisar, reasons). see larry i. palmer, endinos andbeoinninos: law, medicine, and society in assisted life and death (2000) (arguing phyisican-assisted suicide an issue for the legislature, too complex for courts, as it is a product of institutional arrangements between law, medicine, and such). thus, even if one concludes that physician-assisted suicide is not always immoral, there 2006] my fa'iher. john locke and assisted suicide 51 practices· in end-of-life care-pulling the plug,22 refusing treatment, 23 the principle of double effect, 24 and terminal sedation25-is, therefore, appropriate. in part ill, this article discusses the social contract theory and civil republicanism. i explain why the combination of these political philosophies underlying the constitution provide people like my father, both past the age of social security retirement and incapable of ever again participating in the political process, with a right to end their lives. i. the fundamental rights argument as a foregone conclusion given the court's motivation and methodology~ it is hardly surprising that glucksberg was a nine to zero decision. in fact, it is hard to imagine that certiorari would have even been considered if two federal appellate courts had not found a constitutional right to assisted suicide, thereby forcing the issue. once granted, the court had a variety of motivations, both in terms of institutional legitimacy and pragmatism, not to find a fundamental constitutional right in this case. first, it would only be natural for the court to hesitate·entering into an arena so charged with moral content and divided social beliefs. 26 while the sides might not be as polarized as those ofwomen claiming the right to choose and those characterizing abortion as baby murder, the lines in assisted suicide are, in part, formed ftom the same characteristics-most notably, the moral consequences of intentionally taking human life. granted, polls show significant numbers of people supporting assisted suicide for terminally ill, nevertheless may be reasons of social policy to mab it illegal. see, yale kamisar, the rise and fall of the 'right' to assisted suicide, in 'om case against assisted-suicide: for nm right to end-of-life care 87 (kathleen foley & helbert hendon eds., 2002) [hereinafter the case against assisted-suicide]; lance k.. still, physician-assisted suicide: to decriminalize or to legalize, that is the question, in expanding me debate, supra note 19, at 245; sue rodriguez v. attorney gen. can. & attorney gen. b.c., (1993] s.c.r. 579. while morality and values can certainly drive social policy, and social policy can be achieved by attacldng moral labels to certain behaviors, the author believes that a dichotomy between "morality'' and "social policy" is useful for this conversation (even if deconstructable and philosophically oversimplified). 22. see infra part ii.c.2. 23. see infra part ii.c.3. 24. see infra part ii.c.l. 25. see infra part ii.c.4. 26. compare peter singer, rethinking life and death-the collapse of our tradmonal ennes (1994), with wesley j. smi.lh, forced exrr-the suppery swpe from assisted suicide to legalized murder (1997). see also kamisar, future of physician-assistedsuicide,supranote8,at52("roev. wadeignitedwhathasaptlybeencalled a 'domestic war,' one that, after a quarter-century of tumult, seems finally to have come to an end in the courts. the court that decided the assisted suicide cases in 1997 was not eager to set off a new domestic war." (citation omitted)). 52 indiana health lawrbvmw [vol. 3:43 suffering patients. 27 however, those numbers may be a bit misleading. when faced with a specific plan for physician-assisted suicide ("pas''), voters are far less comfortable with the reality than the concept ofpas.28 considering all the state initiatives on pas, only oregon's initiative has passed.29 the supreme court would, therefore, have reasonably foreseen roe redux. they no doubt could imagine case after case returning to the coutf0 challenging 27. lauren neergaard, how people meet death-a major study, seattle post intewoencer. nov. 15, 2000, at 1. ("[b]etween 60o/o-700/o of americans believe terminally ill people in pain should be able to end their lives."). annette e. clark, autonomy and deoth, 7l tulane l. rev. 45, 54-55 (1996); paul j. zwier, looking for a non-legal process: physician-assisted suicide and the care perspective, 30 u. ricil l. rev. 199 (1996); lynn tracy nerland, a cry for help: a comparison of voluntary active euthanasia law, 13 hastings int'l & comp. l. rev.ll5 (stating 58% favor euthanasia in 1988); robert t. hall, final act: sorting out the ethics of physician-assisted suicide, s4 the humanist 13 (1994); (citing 1993 hams poll: 73% favor some form oforegon-likephysician-assisted suicide)< sarah horsfall et al., views of euthanasia from an east texas university, 38 soc. sci. j.617 (2001) (stating roughly 75% of the students at an east texas university are in favor of euthanasia­ similar to general public.);knowledge,aititudes, and behavior. survey finds majority support right to euthanasia and doctor-assisted suicide, aids weekly, jan. 28, 2002, at 13 (stating 61% favor physician-assisted suicide law). see also linda ganzini et al., attitudes of patients with amyotrophic lateral sclerosis and their caregivers toward assisted suicide, 339 new eng.j. mel>. 967,967 (1998) (citingmajorityofpatients in a study in washington and oregon with als would consider assisted suicide). 28. felicia cohn & joanne lynn, vulnerable people: practical rejoinders to claims in favor of assisted suicide, in the case against assisted suicide, supra note 21; liezl van zyl, death and compassion-a virtue based approach to eui11anasia 124-125 (2000). see also ian dowbiggin, a merciful end-the euthanasia movement in modern america 175 (2003) (noting consistently, in the polls one-third support pas, one-third support pas in isolated cases but oppose it in general, and one-third oppose pas in all circumstances. while there is a general endorsement in the abstract right top as, people balk when considering the right in specific si~tions). · 29. see glucksberg, 521 u.s. at 717-718 (noting w~gton and california rejected ballot measures to legalize pas. "since the oregon vote. many proposals to legalize assisted­ suicide have been and continue to be introduced in the states' legislatures, but none has been enacted. and just last year, iowa and rhode island joined the overwhelming majority of states explicitly prohibiting assisted suicide." (citation omitted)). 30. another factor at work in the assisted suicide cases, and one that will operate as well the next time the court confronts the issue, is the justices' realization that if they were to establish aright to assisted suicide. however limited, the need to enact legislation implementing and regulating any such right would generate manyproblems. these inevitably would find their way back to the court. in short, in many respects the legislative response to a supreme court decision establishingrighttoassistedsuicideislikelytobeareplayoftheresponsetoroe v. wade, a specter that did not escape the attention of the justices last year. at one point in the oral arguments, rehnquist told the lead lawyer for the glucksberg plaintiffs: "you're not asking that [this court engage in legislation] now. but surely that's what the next couple of generations are going to have to deal with, what regulations are admissible and what not if we uphold your position here. [y]ou're going to find the same thing ... that perhaps has happened with the abortion cases, there are people who are just totally opposed and people who are totally in favor of them. so you're going to have those factions fighting it out in every session of the legislature-bow far can we go in regulating this. and that 2006] my father, john locke and assisted suicide 53 particular state legislation as allegedly interfering with the. right to pas, or even attacking the legislation as jeopardizing the health and safety of vulnerable populations of citizens31 who might be coerced into pas. 32 second, the court was being asked to· find yet another constitutional right which was not articulated in the text of the constitution. on the one hand, the court has not been unwilling to fmd such substantive rights within the due process clause of the fourteenth amendment. after all, it has been a long time since lochner and the economic due process debacle,33 and approaching forty years since griswold. 34 on the other hand, the court has justifiable concerns with its legitimacy as a non-elected branch of a democratic government when declaring such unenumerated rights,35 and, thereby, binding will be a constitutional decision in every case." kamisar,futureofphysician-assistedsuicide,supranote8,at50-51,51-52(citationomitted). 31. see, e.g., kathleen foley & herbert hendin, introduction: a medical legal psychosocialperspective,in'ihecaseagainstassistbdstncide,supranote21,at13;diane coleman, not dead yei, in 'lhe case against assisted stncide, supra note.21, at 213; john finnis, misunderstanding the case against euthanasia: response to harris's first reply, in eutiianasia examinedetidcal. cunical and legal perspectives 64 (john keourd ed., 1995) [hereinafter eutiianasiaexamined]; singer. supra note 26, at 49, 199 (1995). this concern is said to be particularly acute for the disabled given how society tends to already undervalue them and limit their lifestyle choices. jerome e. bickenbach, disability and life­ ending decisions, in expanding the debate, supra note 19; darrel w. amundson, the significance of inaccurate history in legal consideration of physician-assisted suicide, in physician-assisted suicide, 16 (robert weir ed., 1997) [hereinafter physician-assisted smcide]; singer supra note 26, at 181. 32. in fact, the oregon "death with dignity act," which was passed in 1994, was enjoinedbythefederalcourtsuntil1997. leev. oregon, 107f.3d 1382,1386(9tbcir.1997), cert. den., 522 u.s. 927 (1997); clark, supra note 27, at 61; smith, supra note 26, at 126; simon m. canick, constitutional aspects of physician-assisted suicide after lee v. oregon, 23 am. j. law & med. 69 (1997). the injunction by the federal district court was underlain by an equal protection theory that the lives of certain vulnerable citizens (e.g., those who are terminally ill and suicidal) will be less protected by the state because under the act they will tend to be directed towards pas rather than psychiatric treatment. this claim eventually was rejected by the ninth circuit for lack of"standing" supra, 107 f .3d at 1390, but that does not mean that a similar claim with more compelling facts could not be raised in some future action. 33. see lochnerv. new york, 198 u.s. 45,64 (l905)(holding substantive due process in the. form of the "right to contract" formed basis for finding progressive wage and hour regulations unconstitutional). lochner was overruled in the middle of the depression by west coast hotel co. v. parrish, 300 u.s. 379 (1937). for a critique of lochner, see, e.g., ronald dworkin, lll"e's dominion-an argument about abortion,eutiianasiaandindividualfreboom 121 (l994)("lochner has long since been overruled, and lawyers cite it today only as a paradigm example of supreme court lunacy.''); tribe, supra note 14, at 567-586. but see alan j. meese, will, judgment, and economic liberty: mr. justice souter and the mistranslation of the due process clause, 41 wm.&maryl .. rev. 3, 9-lo (1955)(statingeveniflocbnerwaswronglydecided, courts have been incorrect in bifurcating substantive due process into "economic" (e.g., occupational . liberty) and "other libertiesj. 34. griswold v. connecticut, 381 u.s. 379,479 (1965). 35. as judges are appointed for life and not elected, the justices of the supreme court are understandably cautious when reviewing the work of the democratically elected branch of government, the legislature. see generally john h. ely, democracy and distrust: a 54 indiana health law review [vol. 3:43 all federal and state governmental actions. the justices of the court hardly wish to be seen as·using their positions merely to enforce their own political preferences. 36 within this understandable reluctance of declaring so-called unenumerated rights, the assisted suicide claim was additionally problematic both for (1) the legal theory relied upon to generate the right and (2) the nature of the right itself. a. the legal theory in support of its position, the proponents of the right to assisted suicide cited a passage from the last abortion case decided by the supreme court, planned parenthood v. casey: "at the heart of liberty is the right to define one's own sense of existence, of meanings, of the universe, and of the mystery of human life.'m theory of judicial review 206 (1980) ("(t]here can be no doubt that the judicial branch, at least at the federal level, is significantly less democratic than the legislative and executive.''). ely's concern was reflected in glucksberg: but the court has always been reluctant to expand the concept of substantive due process because guideposts for responsible decisionmakiog in this unchartered area are scarce and open-ended. collins, 503 u.s., at 125. {collins v. harker heights, 503 u.s. 115, 125 (1992) (citing to regents of univ. of mich. v. ewing, 474 u.s. 214, 225-26(1985).] by extending constitutional protection to an asserted right or liberty interest, we, to a great extent, place the matter outside· the area of public debate and legislative action. we must therefore "exercise the utmost care whenever we are ~ to break new ground in this field," jd., lest the liberty protected by the due process clause be ·subtly transformed into the policyprefcrencesofthemembers ofthis court, moore (v. east cleveland], 431 u.s. 494, 502 (1977), 431 u.s. at 502 (plurality opinion). glucksberg, 5211 u.s. at 787. because of this concern, ely proposed that the court should only delve deeply into legislative motives and alternatives when the legislation impacts groups that have been systematically excluded form participation in the political process which crafted the legislation; i.e., when the excluded group constitutes a "discrete and insular minority." ely, supra. for an article applying ely's views to morally-charged issues such as assisted-suicide see ryan e. mick, justification for a constitutional jurisprudence of deference to the state's 'moral judgments.' 12 kan. j. law. & pub. pol'y 379, 381-382 (2003). 36. permitting the supreme court to find unenumerated rights in the constitution of course carries certain risks of justices lending a constitutional mandate to their own personal political-value preferences. dworkin, supra note 33, at 121. that, in filet, is precisely the charge justice scalia leveled against the majority in lawrence v. texas: ''to tell the truth, it does not surprise me, and should surprise no one, that the court has chosen today to revise the standards of stare decisis set forth in casey. it has thereby exposed casey's extraordinary deferencetoprecedentfortheresult-orientedexpedientthatitis." lawrencev. texas,539u.s. 558, 592 (2003) (scalia, j., dissenting). "'tis clear from this that the court has taken sides in the culture war, departing from its role of assuring, as neutral observer, that the democratic rules of engagement are observed." jd. at 602 (scalia, j., dissenting). 37. this language from the opinion in planned parenthood v. casey, 505 u.s. 833, 851 (1992), set the focus for the arguments throughout the federal courts. see discussion in glucksberg, 521 u.s. at 726-27. let me leave this portion of the analysis with a general caution about using the abortion line of cases in a legal battle over assisted suicide. those cases can readily be confined to the 2006] my father, john locke and assisted suicide 55 while earlier non-economic substantive due process cases from the 1920s involved the intersection of rights to direct the raising of one's children abortion arena, so as to have little precedential value in the assisted suicide arena. suicide and assisted suicide involve actual taking of life. central to the roe decision was the court's finding that a fetus was not a viable life in being with independent rights. roe v. wade, 410 u.s. 113, 158 (1973); dworkin, supra note 33, at 36, 110; smith, supra note 26, at 211 (1997); susan m. wolf, physician-assisted suicide, abortion, and treatment refusal-using gender to analyze the difference, in physician-assisted smcidb 167, 180-81. this finding avoided all homicide arguments, leaving only the state's admitted interests in a potential life. alternatively, the court could have found that the fetus was a viable life with rights equal to any other life in the world, except the mother. it could have held that when those rights conflict with those of the mother, the rights of the fetus must give way. the law does recognize that children have lesser rights than adults in a variety of areas. such as the rights to vote, drive, many, buy liquor, and "expectation of privacy rights." see, e.g., t.l.o. v. new jersey, 469 u.s. 325 (1985) (involving searching of student lockers). but the roe court did not choose to take that route. also, the abortion line of cases is deeply entwined with the notion of a woman's right to have control over her own body. wol( supra at 170, 173 (stating abortion, life refusing treatment, involves keeping something out of her body, avoiding "invasion"); planned parenthood v. casey, 505 u. s. 833, 857 (1992). the cases could have been based on precluding any governmental action which substantially fetters women's choices about bow to live their lives (e.g., having a child now keeps her ftom going to college). see, e.g., dworkin, supra note 33, at 57; casey, 505 u. s. at 927 (steven, j., discussing life choices abortion can make possible for a woman). that might have given some support to a position incorporating quality of life notions and ideas about controlling the final stages of life when they become unbearable. but the notion of general control over her life, as contrasted with rights involving control over her body, does not seem to be at the core ofthose cases. smith, supra note 26, at 211; yale k.amisar, the rise and fall of the "righr to assisted suicide, in 'file case against assisted smcjde, supra note 21; wolf, supra note 8, at 71; susan frelicb appleton, assisted suicide and reproductive freedom: exploring some corrections, 16 wash. u.l.q. 15, 17 (1988)(distinguishingassistedsuicideftomreproductiverights);casey,505u.s.at869(1992). you could say that by denying my father sase ("suicide, assisted suicide, and euthanasiaj the state bas totally taken away his control over his own body and is forcing him to suffer for its primarily symbolic interests. it is a plausible analogy, but not completely persuasive. the state is not really interfering with my father's control of his body in the same sense as denying an abortion to a pregnant woman. the state is not making him let the cancer grow in his body except to the extent they can be said to be making him stay alive, which in tum is a logical precondition of any bodily experience. moreover, one could plausibly interpret the roe line of cases so that, rather than incorporating some notion of "general control" over women's bodies, these cases can be seen as being concerned with providing women control over "invasions" of their bodies. that would be consistent with the statement fu cos'ey that abortion rights exist constitutionally at the intersection of rights to privacy and rights to refuse unwanted medical treatment (i.e., unwanted medical invasion of the woman's body). while the cancer surely was invading my father's body, no law precluded him from repelling the invasion (e.g., through surgery, chemotherapy, radiation, and such). sase, on the other hand, is more akin to repelling an invader by destroying the invader along with your entire society. finally, unlike pregnancy and women, cancer is not unique to; or part of, any species survival role related to either gender specific. only women's bodies bear children. that is their burden and joy. it is such a constant part of who they are or who they could become that control over this aspect of their existence is a significant part of having control over themselves throughout much of their lives. casey, 505 u. s. at 869 (1992). in contrast, the current narrative of suicide and assisted suicide takes place in illness, at the very end of life, without any connection to gender. 56 indiana heal til law review [vol. 3:43 with first amendment religious38 and/or associational rights,39 all modem substantive due process casefy-griswold,40 eisenstadt,41 roe,42 planned parenthood v. casey,43 lawrence v. texas44-have basically revolved around a single aspect of human life: sexual relationships. 45 glucksberg thrust the unenumerated rights question into the sphere of life and death. entering this realm of realms, where would the search for unarticulated fundamental rights now lead? this question became poignant given that the guide for developing unenumerated rights was to be the passage from casey extolling autonomy46 as the source of these rights. this is the same autonomy which has been variously characterized as defining one's self through one's choices,47 maintaining a coherent life story,48 and making significant decisions in one's life.49 38. pierce v. society of the sisters, 268 u.s. 510, 530-32 (1925). 39. meyer v. nebraska, 262 u.s. 390, 400-402 (1923). 40. gris'wold, 381 u.s. at479 (1965). 41. eisenstadt v. baird, 405 u.s. 438,443 (1972). 42. roe, 410 u.s. at 113 (1973). see also city of akron v. akron center for reproductive health, inc., 462 u.s. 416 {1983) (holding akron abortion ordinance unconstitutional because it violated a woman's right to privacy); webster v. reproductive health services, 492 u.s. 490 (1989) (holding the state statute prohibiting the use of public employees or facilities for the use of nontherapeutic abortions and prohibiting the use of public funds to encourage women to have nontherapeutic abortions were constitutional and moot respectively);thomburgbv.americancollegeofobstetricians&gynecologists,476u.s. 747 (1986) (holding several provisions of pennsylvania abortion control act unconstitutional); casey, 505 u.s. at 833 (standing generally for the concept that government cannot place an undue burden on a woman's ability to bave an abortion by placing a substantial obstacle in her way). 43. casey, 505.u.s. at 833. 44. lawrence, 539 u.s. at 558. 45. even substantive due process claims rejected by the court tended to bave a sexual flavor. see, e.g., michael h. v. gerald d., 491 u.s. 110 (1989) (holding father of a child from adulterous relationship bas no fundamental right in maintaining parental relationship with child); bowers v. hardwick, 478 u.s. 186 (1986) (holding no fundamental right for gay men to have sex in the privacy of their home) . . see casey, 505 u.s. at 851. 46. autonomy bas become the dominant principle in medical ethics. see paul j. zwier, loolcingfor a nonlegal process: physician-assis'ted suicide and the care perspective, 30 u. rich. l. rev. 199, 228 (1996). "autonomy" is also the sense in which the right to "privacy" bas evolved in american constitutional jurisprudence. see m.t. meulders-klein, the right over one's own body: its scope and limits in comparative law, 4 b. c. int'l & comp. l. rev. 29,61-74 (1983). 47. jobnharris,euthanasiaandthe valueoflife,inelithanasiaexamined,supranote 31, at 11 ("our own choices, decisions, and preferences help make us what we are ... "). 48. see dworkin, supra note 33, at 27, 199-200, 205 (controlling one's narrative maintains an "integrity'' to that life); harris, euthanasia and the value of life, in eu1hanasia examined, supra note 31 at 14. 49. see harris, euthansia and the value of life, in eu1hanasiaexamined, supra note 31 ("[ w]hile someone might bave strong, and for them important, preferences about the manner and timing of their own death, these should be respected because they are just that, strong and important preferences ... j; dan w. brock, physician-assis'ted suicide is' sometimes morally justified, in physician-assisted suicide, supra note 31, at 89-90; but see richard a. 2006] my father, john locke and assisted suicide 57 given the uncertainty of the limits on rights-creation, if this notion of autonomy was held to be coextensive with the defmition of individual conduct protected by the constitution, it is little wonder that justice rehnquist muttered, mumbled and backtracked when he responded to this claim: "that many of the rights and liberties protected by the due process clause sound in personal autonomy does not warrant the sweeping conclusion that any and all important, intimate, and personal decisions are so protected, san antonio independent school dist. v. rodriquez, 411 u.s. l, 33-35 (1973), and casey did not suggest otherwise."50 b. the right claimed in glucksberg the court further realized that the right it was being asked to constitutionalize could not be confined within bright, or even dim, lines. much of the questioning by the court of the respondent focused on the inability to confine any right to pas to terminally ill patients.51 given the mcmormick, bioethics: a moral vacuum?, 180 america 8, 9 (may 1, 1999) ("absolutizing autonomy represents a failure to wrestle with those dimensions of conduct that make choices right or wrong-in brief, a moral vacuum."). 50. glucksberg, 521 u. s. at 727-28. in refusing to apply the casey language, the glucksberg court thus merely noted that the fact that many of the substantive or due process rights the court has declared have sounded in personal autonomy does not mean that any and all important intimate personal decisions are protected as fundamental rights. but the court failed to say why not, let alone provide any criteria for determining when an autonomy-based right is fundamental, and when it is not. the answer is obvious, you might say. we do not want to sanction parents having sex with their children; brothers marrying their sisters; or a 30year old marrying his 12-year old cousin. but none of that necessarily follows from a strong adherence to the casey language. in the first place, in at least two of these examples children are involved, and these can hardly be considered a matter of personal choice in which the state has no interest. in the second place, even if we afford sexual privacy the status of a fundamental right, the state would still be able to counter any strict scrutiny challenge involving these scenarios with a knockout blow: the state's interests in prohibiting incest and sexual abuse of children are plainly substantial. 51. see kamisar, the future of physician suicide, supra note 8 (citing transcript of oral argument at41, washington v. glucksberg, 1997 wl 13671 (jan. 8,1997) (no. 96-110); see also glucksberg, 521 u.s. at 733. thus, rehnquistnoted washington state's insistence that the impact of the ninth circuit's decision-invalidating the state's assisted suicide ban "only 'as applied to competent, terminally ill adults who wish to hasten their deaths by obtaining medication prescribed by their doctors"'-"will not and cannot be so limited." then, he observed: the [ninth circuit's] decision, and its expansive reasoning provide ample support for the state's concerns. the court noted, for example, that the "decision of a duly appointed surrogate decision maker is for all legal purposes the decision of the patient himself' that "in some instances, the patient may be unable to self­ administer the drugs and ... administration by the physician may be the only way the patient may be able to receive them," and that not only physicians, but also family members and loved ones, will inevitably participate in assisting suicide. thus, it turns out that what is couched as a limited right to "physician­ assisted suicide" is likely, in effect, a much broader license, which could prove extremely difficult to police and contain (quoting compassion in dying v. 58 indiana health law review [vol. 3:43 nature of the right asserted, the justices' concern was understandable. the right alleged said to sound in autonomy, had been described alternately as the right to die, 52 the right to "die in the time and manner of one's choosing, "53 and the right to "death with dignity. "54 yet, if one looks carefully at each of these washington, 79 f.3d 790, 831-832, 838 nn. 120, 140 (9th cir. 1996)). glucksberg, 521 u.s. at 733. 52. see, e.g., alan meisel, the right to die 3-12 (1989); kamisar, reasons, supra note 21, at 116 ("the 'right to die' is a catchy rallying cry ... "). some focusing on a "right to live" have even approached the issue as one of waiver. the "right to waive the right to live" is an interesting argument because its first premise is the same as the first premise of the anti­ suicide position (i.e., that the primary function of society is to protect life). i have a "right to live." if i have a right to live, that right is for my protection, and is my right. frances m. kamm, physician-assisted suicide, euthanasia, and intending death, in expanding the debate, supra note 31, at 36; rosamond rhodes, physicians-assisted suicide, and the right to live or die, in expanding the debate, supra note 31, at 167. but cf. the linacrectr. for health care ethics, euthanasia clinical practice & the law 40 (luke gormally ed., 1994) [hereinafter clinical practice] (stating the right involved is really the right "not to be murdered"). as such, i can waive the right, just like i can waive my right against self­ incrimination and confess to a crime, or waive my right against illegal search and seizure and consent to police looking through my house. to be sure, we sometimes require a waiver ceremony or ritual where the person waiving must appear before some formal body or tribunal to make sure they fully understand the right(s) they are giving up and that this is their unfettered choice. see fed. r. crim. p. 11; boykin v. alabama, 395 u.s. 238 (1969) (specifying the required content of the plea ritual). and maybe that would be a good idea in this case, given the irreparable nature of the decision, the concern about coercion, and even the risk of disguised homicide. but in the end, i should be able to give up my right to live and end my life however i choose. this argument has a nice rhetorical ring to it, but ultimately is unconvincing. initially, what can it mean to say one has a right to live when people always die, and die all around us from a variety of causes? i do not think that the idea would resonate well with most if i refused to serve my country in a war claiming that the particular action is too dangerous and thereby unduly burdens my right to live. i do have a fundamental right that my life not be taken without due process, i.e., that i not be killed unjustly. but that is not the same as a right to live. moreover, even ifl had such a right as the "right to live," the state may have sufficient interests in my well-being and its effect on others as to deny me the right to waive it. meulders­ klein, supra note 46, at 38 (prohibiting consent to a battery unless battery is part of a violent sport such as boxing or football); witmore v. arkansas, 495 u.s. 149, 175 n.l (1990)(marshall, j., dissenting) (citing thirteen states prohibiting waiver by defendant of direct appeal in death penalty conviction); finally, while i am protected by the thirteenth amendment against being sold into slavery, that institution is so offensive to a modern society that i cannot waive the protection of the thirteenth amendment and voluntarily sell myself into slavery. daniel callahan, thetroubleddreamoflife: insearchofpeacefuldeath 105 (1993). so, even ifl have a right to live (which is questionable), the state does not necessarily have to let me waive that right. 53. margaret somerville, death talk: the case against euthanasia and physician-assisted suicide 31 (200 l) (hereinafter death talk]. see also glucksberg, 521 u.s. at 722 ("[p]roperly analyzed, the first issue to be resolved is whether there is a liberty interest in determining the time and manner of one's death ... "). but see callahan, supra note 52, at 36-37 (controling everything in life is impossible, and there is a richness from not doing so). 54. daniel callahan & margot white, the legalization of physician-assisted suicide: creating a regulatory potemkin village, 30 u. rich. l. rev. 1, 20 (1996); martin funderson & david j. mayo, altruism and physician assisted death, 18 j. med. & phil. 281, 284-87 2006] my father, john locke and assisted suicide 59 attempts at articulating the fundamental right that was the subject of glucksberg, one is hardly left with clear guidance as to the right's contours. first, there is no need to embody a right to die in the constitution because we all die. second, the time and manner of one's death is a function of chance and circumstance and, absent distributing cyanide capsules, few will ever control it. third, the label death with dignity is a misnomer. death is merely a state of being and is neither dignified nor undignified. ss the term dying with dignity is a more suitable moniker to the right to control one's passing. however, even when applied to dying, there is no consensus on the meaning of dignity. some find dignity in the very fact of being human.s6 some locate dignity in our capacity for moral reasoning. s7 still some see it as a social construction, relating to how the individual carries himself,sa while others conceptualize dignity as some force of grace in the face of the degrading and unjust. 59 rather than attempt a definition of dignity, it would probably be fairer to the proponents of pas in the glucksberg court to equate the phrase dying with dignity with a rejection of bad death. by that i mean that what is meant is not so much a picture of a good death,60 but rather rejection ofa bad death. (1993) (noting we want loved ones to remember us as vital). 55. in fact, death in our culture has many faces. in christian thought, death is "the enemy." see paul ramsey, the indignity of"death with dignity," in death, dying, and euthanasia, 310, 321 (dennis j. horan & david mall eds., 1997) [hereinafter euthanasia] (death is oblivion, which is a :frightening concept). but, death can be seen in many other ways: wim j.m. dekkers,images of death and dying, in bioethics in a european perspective 411 (h.a. ten have & bert gordijn eds., 2002) (describing death as tragic or evil); callahan, supra note 52, at 180 (describing death as a separate epoch unconnected to our lives); ramsey, supra note 55, at 309 (describing death as that which makes us value our days); abraham joshua heschel, i asked for wonder, a spiritual annfolooy 72 (samual h. dressner ed., 1984) (describing death as a giving away which is "reciprocity on man's part for god's gift oflifej. 56. gennain grisez, suicide and euthanasia, in e\1111anasia supra note 55, at 782; finnis, supra note 31, at 69; luke gormally, walton davis, boyd and the legalization of euthanasia, in euthanasia examined 113, 115 (john keown ed., 1995); fr. robert barry, o.p., the development of the roman catholic teachings on suicide. 9 notre dame j.l. ethics & pub. pol'y 449,498 (1995); sylvia d. stolberg, human dignity and disease, disability, suffering: a philosophical contribution to the euthanasia and assisted suicide debate, in death talk: the case against euthanasia and physician-assisted suicide 255, 255 (margaret sommerviue ed., 2001); id. at 267 (noting that historically, dignity dealt with honor, inequality of attributes; only in the modem view do all persons have equal dignity). 51. see alan donagan, the theory of morauiy 237 (1977). but see elaine scarry, the body in pain: the making and unmak1no of the world 29; 35 (1985) (arguing that intense pain destroys the person's self and world). 58. seecailahan,supranote52,at141;ramsey,supranote55,at307;stolberg,supra note 56, at 257 (reasoning that this notion of dignity should be thought of as "social dignityj. 59. thus, i believe that a person can be totally dependant and ill, and yet retain his dignity; a view which others share. see, e.g., callahan, supra note 52, at 12-21; stolberg, supra note 56, at 258-59. 60. this notion reflects the greek ideal of"good death." see john m. cooper, greek· philosophers on euthanasia and suicide, in suicide and euthanasia: historical and contemporary themes 9 {baruch a brody ed., 1989). as such, the term euthanasia "is 60 indiana health law review [vol. 3:43 it is this latter narrative, this dying without dignity, which the proponents of pas sought to prevent. in this bad death narrative, the person is in pain and soiling himself, with tubes and machines humming away (although, if these are life-supporting tubes and machines, the patient can request that they be removed and shut ofl).61 why must a patient endure this? why can the patient not exercise his autonomy and choose to end this mockery of his existence with the assistance of a physician through pas? to permit less denies them the right to die with dignity. 62 but for the glucksberg court, there was more than this sympathetic narrative to behold. there was the next case and the next case. initially, if you give the patient the right to pas, how can one limit that right so as to exclude euthanasia'rl one might answer that as an administrative/policy matter, the distinction is clear: with pas, the physician provides the lethal pills. it is the patient's choice alone whether or not to take the pills. this gives a chance for the patient to choose not to take the pills, and gives some assurance that, if the patient does choose to take the pills, his actions reflect a voluntary choice. it also keeps members of the medical profession from directly killing their patient (e.g., with a lethal injection).64 but justified as this distinction may be in the halls of policy, it will lose cultural legitimacy when the public sees cases of sick, suffering people who are incapable of picking up the pills and/or swallowing the pills themselves. if they have a fundamental right to dying with dignity, how can they be denied the only means available to them to exercise that right? derived from the greek word eu, meaning 'well', and thanatos meaning 'death', and early on signified 'good' or 'easy' death." steve zankas & wendy coduti, eugenics, euthanasia, and physician assisted suicide, 72 j. rehab. 27, 28 (2006). 61. see cruzan v. missouri department of health, 497 u.s. 261, 310-11 (brennan, j., dissenting) (1984). see also infra notes 100-105 and accompanying text 62. as some have noted, however, dying with dignity and autonomy can conflict: if dignity refers to the way one lives as a sick or dying patient-the extent to which one retains dignity during the trials of illness and decline-and also to the way one dies-i.e., quietly, peacefully, as a competent individual rather than sedated and incompetent or violently through a ''makeshift" suicide-then dignity does not refer simply to autonomy. instead, dignity refers to a specific valuation of the quality of one human being's existence and his dying process. thus, respecting someone's dignity in the "death with dignity" context presupposes making a.value judgment about an individual's quality oflife, while respecting that same person's autonomy would require us to avoid making such value judgments. shepherd, supra note 8, at 453. 63. see len doyl, why active euthanasia and physician assisted suicide should be legalized, 323 bmj 1079, 1080 (2001) (stating logically, it will be difficult to hold the line between pas and voluntary, active euthanasia). 64. see glucksberg, 521 u.s. at 731 (concerning the state's interest "in protecting the integrity and ethics of the medical profession" and the ama's conclusion that "[p]hysician­ assisted suicide is fundamentally incompatible with the physician's role as healer."). see also yacco, 521 u.s. at 800-01 (relying on the fact that the distinction between assisted suicide and withdrawing life-sustaining treatment was "widely recognized and endorsed in the medical profession"). 2006] my father, john locke and assisted suicide 61 to suggest that all competent adults have the right to physician assisted suicide would be startling to most. the fact is that over· time, it may be difficult to limit pas's use to those we now envision as terminally ill and suffering. first, assuming we can even define who is and who is not terminally ill, 65 it will not be reasonable to confine the right to only the terminally ill. 66 non-terminal patients suffering as the result of massive injuries or those inflicted with a wasting disease can, in some ways, be in a far worse position than those with a terminal illness, e.g. six months or a year to live. the suffering of non-terminal patients can go on and on, while, for the terminally ill, the end is in sight. also, it would be difficult to limit· suffering to pure physical pain. 67 suffering is far more complex. it is a mix of the physical, emotional, existential, and psychological. even suffering from physical pain has 65. for example, under the oregon "death with dignity act" the definition of''terminal" is unclear whether the definition is meant to be with or without treatment. john keown, euthanasia, ennes, and pubucpolicy: an argument against legislation 171 (2002); callahan &white, supra note 54, at 44. further, 500/0 oforegon doctors say they cannot predict whether a patient will die within six months. see keown, supra at 172. q: yale kamisar, the "right to die": ondrawing(anderasing)lines, 35 duq.l. rev.481, 504 (1996) ("deciding what should count as 'terminally ill' will pose such severe difficulties that it seems untenable as a criterion for permitting physician assisted suicide." (citation omitted)). 66. see generally juliet cassuto rotiiman, sa yino goodbye to danielwhen death is the best choice (1995). see also glynn. supra note 8 (suggesting that any legislative distinction between seriously ill terminal patients and seriously ill, chronic non­ terminal patients, would violate equal protection). cf. also brian clark, whose life is it anyway? (1978). see also, linda oanzini et al., attitudes of patients with amyotrophic lateral sclerosis and their care givers towards assisted suicide, 339 new eng. j. med. 967,967-73 (1998) (stating majority of patients in washington and oregon with als would consider assisted suicide). in fact, most who allowed pas under the oregon act have cancer orals. see keown, supra note 65, at 177. but see mitchai.bom, tuesdays with morrie: an old man, a young man, and life's greatest lesson (1997) (story of man with als who lived life fully and passionately until the very end). 67. see e. emanuel, k. hedberg & t. quill, evaluating requests for assisted suicide, in euthanasia: contemporary issues companion 49, 5~51 (lisa yount ed., 2002) [hereinafter contemporary issues] ("loss of control, fear of abandonment or burdening others, financilll. hardships, physical and psychological symptoms, and personal beliefs are all potential causes of suffering.''); harvey m. chochinov & leonard schwartz, depression and the will to live in the psychological landscape of terminally ill patients, in the case against assisted suicide supra note 21, at 298-302; callahan, supra note 52, at 100-1 02; nathan i. cherney & russell k. portenoy, sedation in the management of refractory symptoms: the complexities of assisted suicide,10 j. pawanve care 31, 34 (1994) ("the approach suggested in the evaluation of unrelieved physical symptoms becomes more difficult if symptoms are psychological or suffering is perceived to relate to existential or spiritual concerns."); stacy diloreto, the complexities of assisted suicide, 34 patient care 65, 69 · (2000); zbigniew zylicz, ethical considerations in the treatment of pain in a hospice environment, 41 patient educ. & counseung 47,47-53 (2000); herbert hendin, suicide, assisted suicide, and medical rlness, 16 harvard mental health letrer (harvard medical school) jan. 2000, at 4-7. 62 indiana hea.lm law review [vol. 3:43 emotional and psychological elements. 68 in fact, most terminal patients who seek assisted suicide do not do so because of physical pain.69 they are worn down from the breakdown of their bodily functions, their inability to care for themselves, inability to be part of a social community, the emotional and financial burden they feel they are to their loved ones, and their general sense of hopelessness. 70 of course, once law cuts the mooring from physical pain, how can it ignore unremitting psychological suffering? does a broken leg cause as much physical (let alone emotional) pain as having a spouse suddenly announce that she is leaving and wants a divorce? once law severs the right to assisted suicide from a condition of a terminal illness, as it inevitably will, it will then be left with mixed standards of suffering and dignity. as a resul~ legal advocates might coin the phrase living with dignity. that metaphor, however, could exceed the context of misery and suffering and lead to arguments that there exists a basic list of rights that are preconditions for living with dignity. however, this path is one on which the court has already indicated its unwillingness to trod, having already refused to find fundamental rights to minimum levels of education, housing, healthcare, and employment or welfare. 71 the court's motivation was clear and. reasonable: for reasons of both institutional legitimacy and pragmatism, it simply could not recognize this right to assisted suicide. the court's methodology for locating substantive fundamental rights within the due process clause of the fourteenth amendmen~ in turn, assured that it would not have to recognize this right. c. fundamental rights methodology and pas the glucksberg court used a three-prong test to determine whether the asserted right to die was a fundamental right. 72 first, the right claimed to be 68. see edmund p. pellegrino, the falsepromiseofbenejicent killing, in regulating how we die: the ethical, mbdicaland legal issues surrounding physician-assisted suicide74(lindaemanueled., 1998)[hereinafterregulatinghowwedie];vanzyl,supra note 28, at 218; don marquis, the wealmess of the case for legalizing physician-assisted suicide, in expanding tile debate, supra note 19, at 271; anne lanceley w"jder issues in pain management, 4 european j. cancer carli 1s3 (1995). q: elaine scarry; supra note s1, at 4-6 (noting one cannot experience another's pain). 69. e. emanuel et al., evaluating requests for assisted suicide, in contemporary issues, supra note 67, at 79; diloreto, supra note 67, at 49, 51. 70. id. seealsojamesv.laveryetai.,originsofthedesireforeuthanosiaandassisted suicide in people with hiv-1 or aids: a qualitative study, 358 the lancet, aug. 4, 2001, at 362 (stating principle sources of suffering includes loss of community, loss of self, existential misery). 71. this is hardly an enterprise into which the court would wish to be drawn since the court has already refused to find fundamental constitutional rights to education in plyler v. doe, 457 u.s. 202,223 (1982) (and in san antonio indep. sch. dist. v. rodriguez, 411 u.s. 1, ss (1973)), to housing in lindseyv. nonnet, 405 u.s. s6, 14 (1972); and to welfare in dandridge v. williams, 397 u.s. 471,485 (1970). 72. glucksberg, 521 u.s. at 720-721. 2006] my fa 'iller, john locke and assisted suicide 63 fundamental had to be "carefully describ[ ed]. "73 second, it had to be "deeply­ rooted in this nation's history and traditions."74 third, the claimed right had to be "implicit in the concept of ordered liberty such that neither liberty nor justice would exist if they were ·sacrificed. "75 without going any further, it should be clear that with indeterminate, subjective modifying terms like "deeply'' and "implicit" at the center of the analysis, there is going to be little predictive dependability to the analysis. this analysis· can resuh in opposite conclusions that both sound reasonable. the gluclrsberg case was over the instant that the court defined the right at stake in its most concrete form as being "a right to commit suicide which itself includes a right to assistance in doing so."76 the analysis which followed was predictable. far from being deeply-rooted in history and tradition, suicide and assisted suicide has long been punished or otherwise disapproved of at common law. 77 thus, assisted suicide cannot be a fundamental right the court, of course, could have seen the history and tradition of this nation as tied to its roots in western civilization and chosen as its tradition one which goes back at least to the ancient greeks, "relieving suffering at the end of life. "78 additional consideration of the recent advent of life-prolonging medical technology not available in the past (during which time period people 73. jd. at 721 (quoting reno v. flores, 507 u.s. 292,302 (1993)). 74. jd. at 721 (quoting moore v. east cleveland, 431 u.s. 494, 503 (1977)). 15. jd. at 721 (quoting palko v. connecticut, 302 u.s. 319, 325-26 (1937)). 76. the court explained its decision to define the right in terms of the concrete features of the actus as follows: [w]ebaveatraditionofcareftallyfonnulatingtheinterestatstakeinsubstantive­ due-process cases. for example, although cruzan is often described as a "right to die'' case, see [compassion in dying v. washington, 79 f.3d 790, 799 (9th 1996)]post,at745(stevensj.,concurringinjudgment)(cruzanrecognized''the more specific interest in making decisions about how to confront an imminent death"), we were, in fact, more precise: we assumed that the constitution granted competent persons a "constitutionally protected right to refuse life-saving hydration and nutrition." cruzan, 497 u.s. at 279; id. at 287 (o'connor. j., concurring) ("[a] liberty interest in refusing unwanted medical treatment may be inferred ftom our prior decisions"). the washington statute at issue in this case prohibits "aiding another person to attempt suicide," wash. rev. code §9a.36.060(1) (1994), "and, thus, the question before use is whether the "liberty'• specially protected by the due process clause includes a right to commit suicide which itself includes a right to assistance in doing so." jd. at 722-23 (emphasis added) (citation omitted). 77. id. at 711. (''more specifically, for over 700 years, the anglo-american common-law tradition has punished or otherwise disapproved of both suicide and assisted suicide."). 78. in early greece, physicians could provide poison without negative connotations. see roberti.misbin,eurhanasia:thegoodoftiiepatienf, thegoodofsociety47(1992). while not condoning administering poison, the school of hippocrates believed in trying to do away with suffering. see rein jassen & zbigniew zylicz,articulating the concept of palliative care: philosophiclll and theologiclll perspectives, is j. pawative care 38, 39 (1999); michael hyde, the call of conscience: heideooer and levinas and tile eurhanasia debate 166(2000). 64 indiana health law review [vol. 3:43 with diseases generally died quickly)79 also could have played a role in the court's perception of this nation's tradition.80 these just were not rhetorical moves the court was motivated to employ. ii. taking a closer look at the equal protection argument the equal protection argument presented to the court was straight­ forward. those who have lifesaving treatments which can be refused, or are in need of pain medications that can be given in a fatal dose, or are willing to be terminally sedated, can end their lives. those equally sick and suffering who do not happen to need a respirator or pain medication are forbidden to end 79. in the past, people died at all ages, and quickly. see callahan, supra note 52, at 96. decisions about medical treatment and the end oflife are more complicated now than they have ever been ..• perhaps the single most important reason for this is the advances in medicine in recent years, and particularly the application of medical technology~ as a result, patients live longer, where in the past they would have died. at an earlier stage of their illnesses. extracts from the report of the house of lords select committee on medical ethics, in euthanasia e:xamined: etiucal, cunical and legal perspectives 96 (john keown ed., 1995); sheryl a. russ, care of the older person: the ethical challenge of american medicine, 4 issues l. & med. 87,88 (1988). now it takes time to die, and most deaths are of the chronically ill, elderly. see callahan,supronote52,at32-33,47;maryclement&l>erekhumphrey,theunspoken argument: euthanasia and nm high cost of dying 15 (ergo 2002); joyce ann schofield, care of the older person: the ethical challenge to american medicine, 4 issues l. & med. 53, 53 (1989); russ, supra at 88; cruzan, 491 u.s. at 328-329. similar demographics appear in britain. david field, palliative medicine and the medtcalization of death, 3 eur. j. cancer care 58, 59 (1994). 80. if one seeks tradition to support claimed fundamental rights, while casting those rights in terms of their concrete actus, then making contraceptives available to umnarried lovers, eisenstadtv. baird, 405 u.s. 438 (1972), protecting gay male sex, lawrencev. texas, 539 u.s. 558 (2003), and protecting the right to abortion, roe v. wade, 410 u.s. 113 (1973), would all fail the test. kreimer, supra note 8, at 871-72. the same would hold true with protecting marriage between white men and black women,lovingv. virginia,388u.s.l, 7,11-12(1967),andforbiddingtheforcedseparation ofblack and white school children. brown v. bd. ofeduc., 347 u.s. 483 (1954). while the latter two cases fell under the fourteenth amendment equal protection clause rather than substantive due process, both required a change in the definition of the right at stake in order to escape tradition. the legality of school segregation was assumed at the time the fourteenth amendment was ratified. see, e.g., james e. bond, no easy w au{ to freedom: reconstruction and me ratification of me fourteen'ih amendment 92 (1997) (in louisiana "[t]hough the debate over public $cation was a lively one, no one who participated in that debate appears to have argued that integrated schools would be required by the equal protection clause of the fourteenth amendment .•. ;. in fact, only when the respective "rights" in brown and loving were described by the courts as the rights of school children not to suffer unnecessary psychological harm and for adults to freely choose their life partner, did all this "tradition" cease: brown, 347 u.s. at493-94;loving, 388 u.s. at 12. but see lawrence, 539 u.s. at 588 (scalia, j., dissenting) (turning the tradition argument on its head by positing that glucksberg's reliance on the concept of "deeply rooted in the nation's history and tradition" for fundamental rights analysis has "eroded" roe and casey). 2006] my fa~ john locke and assisted suicide 65 their lives.81 proponents of pas claim that distinction in the law violates equal protection. a. constructing the class the first step in any equal protection analysis is to specify the class of people who are unfairly discriminated against this first step is not so .simple in the assisted suicide context a class based on race . or gender is easily constructed, but what are the parameters of this class? one may think that i am making this far too difficult. the structure. of an equal protection argument itself requires considering a class definition which corresponds to the relevant set of characteristics which people in the offended class have in common with those considering life-ending options such as withdrawing or refusing treatment. after all, that is the group to which the protected class of people will be compared under an equal protection analysis. but all is not so easy. those people are not necessarily dying; paralysis may require a ventilator. they are not necessarily in pain; someone may refuse some form of heart surgery without which they will peacefully die. for the sake of argument, however, imagine the class has been established and protected. the class has members like my elderly father who are dying and suffering extreme pain. the determinative issue will be the level of scrutiny the court employs in reviewing the legislation. the court in yacco v. quill correctly chose minimum scrutiny. 82 b. people like j.zy father and the appropriate standard of scrutiny even if the class is defined to contour with my father's circumstances, it does not result in a class entitled to the highest level of scrutiny (i.e., strict scrutiny).83 the elderly-dying were neither the subject of the fourteenth amendment nor, as far as i know, historical objects of discriinination.ba in 81. the y acco court characterized the equal protection argument before it as follows: "[b]ecause new york permits a competent person to refuse life-sustaining medical treatment. and because the refusal of such treatment is 'essentially the same thing' as physician-assisted suicide, new york's essisted-suicide ban violates the equal protection clause." vacco v. quill, 521 u.s. 793,798 (1997) (citing quill v. koppell. 870 f. supp. 78, 84-85 (s.d.n.y. 1994). 82. yacco,521 u.s. at799. ltshouldbenotedthatthesecondcircuitalsomadeitsequal protection decision employing a "rational basis" test see quill v. v acco, 80 f .3d at 731 (2d cir. 1996). see also flumenbaum & karp, aupra note 7, at 4. 83. the strict scrutiny standard of review is articulated as "narrowly tailored" to meet a compelling need. wygant v. jackson bd. ofeduc., 476 u.s. 267, 280 n.6 (1986). 84. as professors allan ides and christopher n. may explained in constitutional law: individual rights 205 (2d ed. 2001), strict scrutiny appropriately applies to laws making classifications involving .. disadvantaged racial minorities": all of these suggested rationales for heightened scrutiny apply witb respect to laws that disadvantage racial minorities. in terms of first-degree prejudice, this nation's history of black slavery and racial discrimination leaves no doubt that racial minorities have been and are often still the objects· of hatred and 66 indiana heallll law review [vol. 3:43 fact, before the medicalization of death, they were cared for by family in their homes. while the elderly-dying may not be able to participate in the political process in their current condition (even given absentee ballots and e-mail), they hardly represent anything akin to an "insular racial minority'' 85 because they cover the full spectrum of race, gender and wealth. when younger and healthier, those elderly and dying citizens had the opportunity to influence the democratic, political process. in fact, they may have been former congress persons, or even president in their current states, many have influential family networks and the support of organizations like the american association of retired persons ("aarp"). and their interests are likely protected by the active, middle-aged who (unlike youth) know that their time with old age and illness is on the horizon. in short, they are not without influence in the political process. nor is there anything about the elderly-dying class that is comparable to gender such that legislation treating class members differently must be reviewed through the lens of intermediate scrutiny.86 with gender, there were many harmful stereotypes. 87 there are certainly such stereotypes about older people. my grandmother told me how furious she would become because "people either talk to you like you're some kind of little child ... or they think you can't hear, and they. have to scream at you.•• but it is not clear that there vilification. second-degree prejudice is likewise present in the form of widespread and exaggerated negative stereotypes about the intelligence. morality, industry. and-honesty of racial minority groups. next, race is an immutable characteristic; and since most legislatures are white, there is a danger that laws singling out racial minorities for adverse treatment may bave been adopted because of the legislature's inability to empathize with those targeted by the measure. in addition, race is generally. if not always. irrelevant to a person's abilities. finally, racial minorities bave historically been excluded from the political process, initially by outright denial of the right to vote and later through such devices as literacy tests, poll taxes, and physical intimidation. 85. "dying people are clearly not a discrete and insular minority in the same, sure way as are black people subject to race discrimination laws [or] women subject to abortion restrictions." robert burt, constititutionalizing physician-assisted suicide: will lightening strike thrice?, 35 ouq.l.rev. 159, 179(1996); kami.sar,meaningandlmpact,supranote 8, at915-16(quotingburt,supra);cityofclebumev.clebumelivingcenter,473u.s.432,44546 (1985): [l]t would be difficult to find a principled way to distinguish a variety of other groups who bave perhaps immutable disabilities setting them off from others, who cannot themselves mandate the desired legislative responses, and who can claim some degree of prejudice from at least part of the. public at large. one need mention in this respect only the aging, the disabled, the mentally ill, and the infirm. we are reluctant to set out on tbat course, and we decline to do so. cleburne, 473 u.s. at 445-46 ( 1985); accord ides & may, supra note 84, at 246. 86. see frontiero v. richardson, 411 u.s. 677, 688 (1973); michael m. v. sonoma county, 450 u.s. 464, 468-69 (1981) (noting the standard of review requires that the law reflects no gender"stereotypes," tbat it serve as important governmental objectives, and tbat the objectives be genuine). 87. frontiero, 411 u.s. at 688; michael m., 450 u.s. at468-69. 2006] my father, john locke and assisted suicide 67 even exists a set of stereotypes about the elderly-dying; in any event any such stereotypes would not be so comparable to the destructive stereotypes about gender that courts would be required to carefully screen legislation that may affect them. therefore, the vacco court was correct when it chose minimum rationality. c. there is a "rational" basis for distinguishing pas from withdrawing treatment, refusing treatment, principle of double-effect ("pde "), and terminal sedation 1. the principle of double-effect a painkiller such as morphine can, in sufficient doses, stop the patient's breathing. when dealing with terminal patients who are in great pain, such as my father, it is not uncommon for health care providers to risk high doses of a drug such as morphine to control pain even though it is foreseeable that there is a reasonable likelihood the dosage will kill the patient. this is the principle of double-effect. the intention and motive is to control pain, although resulting death is foreseeable. those in favor of a right to suicide and assisted suicide would take the position that action with the foreseeable result of death and action with the intention of death is the same thing. to attempt to distinguish among the two is arbitrary and hypocritical. those opposed to suicide and assisted suicide would argue that they are different because the motive of double-effect is to stop the pain, and death is but the unfortunate side effect. as such, the doctor is like a general who sends his troops onto a beachhead knowing fifty percent will die; his motive is to defeat the enemy, his men's death an unfortunate side-effect of that heroic effort. in some sense, i think the positions of both sides of the debate are off target. 88 88. joseph m. boyle, jr., toward understanding the principle of double effect, 90 ethics 527, 535 (1980). there are differences between intention and foreseeability. !d. we can avoid what we intend to do by not doing it. !d. but not all consequences and side effects, foreseen and unforeseen, can be avoided !d. also, intention is ''voluntary" in a different way than are the foreseeable results of our intentional actions. !d. foreseeable consequences go into our decisions (i.e., do we act in spite of the foreseeable consequences?), but they are not our intentions. !d. van zyl, supra note 28, at 129. yet, at times we hold people responsible for some things that are foreseeable consequences of their intentions. to make such decisions, "motive" is a poor analytic tool. imagine a healthy twenty-year-old who suffered severe pain after being in an accident. he would suffer for several hours of such pain without morphine, but it was foreseeable that the required dose would kill him. if a doctor whose "motive" was pain relief administered the lethal dose although he foresaw the risk, i believe he would be facing some serious criminal charge. on the other hand, my father's doctor clearly would not. 68 indiana health law review [vol. 3:43 a. a genera/look at risk and responsibility the criminal law analyzes culpability differently for death from intentional killing than it does for death resulting from risk-taking activities. we have several analytic tools to assess responsibility for foreseeable risk. american law employs different sets of tools for analyzing culpability as the result of intentional killing.and for analyzing death as the result of risk-taking (foreseeability). when dealing with intentional killings; sanctity of life will presumptively trump all other considerations, except for a few narrowly defined exceptions (e.g., self defense). intentional killings are never subject to a case-by-case, situational balancing of factors or competing interests. intentional killing is intentional killing. the defendant's state of mind (mens rea) will determine the degree of homicide (murder one, murder two, manslaughter), and motive may provide mitigation for punishment; but outside of the narrow categorical exceptions, an intentional killing will always be a homicide. death resulting from risk taking (foreseeability), in contrast, will always be a function of a balancing of values within the specific context: broadly, the analysis will require an assessment of the magnitude of the risk balanced against the perceived social utility of the action. this balancing approach explains the scenario of the general sending fifty percent of his soldiers to die on a beach. 89 successfully conducting a war has high perceived social utility which justifies extremely high magnitudes of risk that life will be lost if this was a training exercise rather than actual warfare in which it was foreseeable that fifty percent of the soldiers would die, the general's motive would not matter to us. these unfortunate side-effects would likely result in some form of homicide charge due to the lower social utility of the training exercise as compared to actual war. in the same way, we permit driving although it is a foreseeably deadly enterprise. we even agree to raise the speed limit, knowing that it will correlate to a statistical increase in real lives lost, because of the perceived social utility of driving.90 in contrast, we do not care if you play russian roulette with one or five bullets, or even if one attempts to make the game safe by trying to palm the bullets at the last moment.91 because this game has absolutely no social utility, any foreseeable risk of death is too much. if someone dies, one is guilty of some level of homicide. this balancing between risk and utility accounts for the seemingly special status of the hospital operating room. we regularly accept surgery 89. see supra part ii.c.l.a. 90. nat'l highway traffic safety admin., fed. highway admin. & u.s. dept. of transport. report to congress: the effecr of increased speed limits in tile posr­ nmsl era iii (1998). 91. see, e.g., commonwealth v. atencio,189 n.e.2d 323 (1963). 2006] my father, john locke and assisted suicide 69 with a high risk of death.92 but, the context of this medical gamble is that there is a higher risk of death, or comparably awful fate, without the surgery. if a doctor conducted a procedure with a forty percent risk of death for an elective cosmetic face lift, even with the patient's consent, that doctor would probably need a criminal defense attorney. finally, though the risk taking and intentionality analyses differ, under the appropriate circumstances, they can result in the same magnitude of culpability.93 if a person is in such a hurry that he cuts across a crowded school lot driving eighty miles per hour and kills a child, even though that was not his intention, the high magnitude of risk and low social utility will combine so that we will attribute malice to him, and treat him exactly the same as an intentional murderer. b. risk, pde and suicide there are of course differences between pde and assisted suicide. pde involves risk of death. assisted suicide is not a matter of risk, but certainty (at least if not botched). on the other band, in a particular case that risk might approach certainty, yet still qualify at pde. therefore, the analysis must move from a risk analysis to a policy analysis. law is concerned with good social policy, including circumscribing the sweep of a law and its enforcement. in this regard, pde is only permissible in very narrowly defined circumstances where risk and utility permit it while assisted suicide would have no such narrow boundaries. this, however, is an argument out of context. even those favoring assisted suicide do so within a very narrow narrative. no one thinks that it is a generally good idea for people to kill themselves. this article is not talking about heartbroken romeo and juliet wannabes. it is instead focused on the terminally ill who are suffering. it is in this context that the argument for equal opportunity to terminate life under these circumstances is compelling. even in this context, the state nevertheless can provide rational grounds for distinguishing between pde and assisted suicide. pde only happens when the person is in such extreme physical pain that a drug of the power of morphine is indicated in doses substantial enough to result in death. these are . the very people who provide the purest narrative for terminating life, i.e., dying people in excruciating physical pain. they also offer a discrete, easily identifiable group. to go beyond them greatly expands the population of those for which termination of life will be condoned, and muddles the analytic waters by going beyond severe physical pain to all aspects of suffering. this is particularly so since all studies of terminally ill patients who express a wish 92. glanville wllllams, the sanctity of life and the criminal law 323 (alfred a. knopfed., 1972)(1957). 93. thus, at times, we treat extreme, unjustifiable risk-taking as the moral and legal equivalent of intentional action. cunical practice, supra note 52, at 38. 70 indiana health law review [vol. 3:43 to die indicate that they generally do so for emotional, psychological, and spiritual reasons, not to avoid actual physical pain.94 one can disagree with making a legal distinction between pde and assisted suicide. i do not see, however, how one can maintain that the distinction is irrational or arbitrary.95 94. the legalization of physician assisted suicide: a very modest revolution, 38 b.c.l. rev. 443, 453-54 (1997). 95. vacco, 521 u.s. at 801. the vacco court's reference to the notion that "when a patient refuses life-sustaining medical treatment, he dies ftom an underlying filtal disease or pathology; but if a patient ingests lethal medication prescribed by a physician, he is killed by that medication" can reasonably lead to the conclusion that the court implicitly valued the "act­ omission" dichotomy. appleton, supra note 37, at 21. the argument employing this distinction posits that the doctor is not acting when pulling the plug, or tailing to resuscitate. or not treating a patient when they have the flu. robert t. hall, final act: sorting out the ethics ofphysician-assisted suicide, 54 the humanist, nov.­ dec. 1994, at 10-11. she rather is omitting to act, and leaving the patient where he or she would have been if the doctor were not in the picture initially, there is a sense of possible wordplay in this argument to the extent that some have contended that this purported distinction makes no sense. id. physically shutting off a respirator seems to be an intentional act. a decision not to put someone on a respirator, however, could also be characterized as an intentional act, perhaps involving review of patient records, consultation with staff and family, and such. in fact, it is because our society now makes no distinction between the two situations (turning on the respirator and turning it oft), that doctors are not deterred ftom starting a patient on the support of a machine for fear that, once started, they cannot act and turn it off. extracts from the report of the house of lords select committee on medical ethics, in euthanasia examined, supra note 79. see, e.g., in re conroy, 486 a.2d 1209 (1985). cj. k.amisar, reosons, supra note 21. on the other hand, there surely are distinctions between the consequences of acting and fuilure to act (omissions). in the first place, i cannot avoid all consequences of my actions. joseph boyle, sanctity of life and suicide: tensions and developments within common morality, in suicide and euthanasia-historical and coni'emporary themes 221-231 (baruch a. brody ed., 1989) [hereinafter historical & coni'emporary themes). i can, however, avoid acting. also, if i give a dollar to a street person, i intend that they have the money; and, as a result of my action, they do. if i walk past without giving a dollar, it would seem rhetorical gameplaying to say that i just deprived that person of a dollar in the same way as if i reached into the basket in front of them and snatched it out. unlike holding me responsible for my chosen actions, the moral consequences of my fuilure to act are are more diffuse. i am constantly not acting. i could always do more to help. i am not inviting homeless people into my house for shelter on cold nights. i am not sending money to afiica to combat malaria yet, few would hold me directly responsible for the plight of those homeless people on that cold night, or some child dying from malaria on the afiican continent. that said, it is not always simple to assess responsibility for tailing to act. sometimes the factual circumstances between intentional action and omission can be very close. while the decision when to place moral responsibility on a fuilure to act can be comprised of a complex array of narratives, the determininative f8ctor in the analysis is generally duty, and the issue of ethical responsibility is a function of whether or not one has a duty. jeff mcmahan, killing, letting die, and withdrawing aid, 103 ennes 250, 264-65,271 (dworkin et al. eds., 1993) (discussing actions judged in "role based" capacity); john a. robertson, involuntary euthanasia ofdefectivenewborns:alega/analysis,indeatii,dyingandeui'hanasiai53-154(dennis j. horan & david mall eds., 1980) [hereinafter dea1h-dying] (discussing duty and correlative responsibility of parents and physicians for omissions); lawrence 0. gostin, drawing a line between kiuing and letting die: the law and law reform on medically assisted dying, 21 j. l. med. & ethics 94, 95 (1993) (discussing the distinction medical ethics and law have 2006] my father, john locke and assisted suicide 71 2. terminating life sustaining treatment (pulling the plug) the argument here is that we permit people to die this way,96 and in fact most people who die in hospitals and nursing homes will die this way (or through related methods such as withdrawing artificially provided food and hydration, do not resuscitate ("dnr") orders, intentional decisions not to treat flu or pneumonia, and such).97 yet this is indistinguishable from intentional drawn between withdrawal of treatment and physician~assisted suicide); submission to the select committee of the house of lords on medical ethics by the linacre centre for health care ethics, in cuncalpractice, supra note 52. see also alan donagan, the theory of morauty 48 ( 1977) (stating that to say a bank guard who leaves her post "allowed" robbery is understandable it would, however, be absurd to say the guard "caused" robbery); marc staunch, causal authorship and the equality principle: a defense of the acts-omissions distinction in euthanasia, 26 j. med. ethics 237 (2000) (stating we would not say that an ordinary passerby "caused" a street person's hunger). the question is whether under the norms of our society one is obligated to act. if one's five-year-old daughter is begging for food, and i walk by, under normal circumstances, one would not bold me, or any of the others who walk by, responsible for her hunger. there is something wrong that in this society a child would be hungry, but we would not generally blame the individual who walks by as if they snatched a sandwich from her hands. her father is a different story. if he sits munching on a big mac while she suffers malnutrition, we do hold him responsible. by virtue of his familial relationship as her father, he has a duty to see her basic needs are met. we, therefore, make no distinction between whether he snatched her food or failed to provide food to her. morally (and legally) it is the same. this brings us back to turning off the respirator. my doctor has a special duty towards me. while passersbys can watch me go into convulsions and walk by without doing a thing, my doctor cannot. she has a duty to provide me with competent medical care. if she does not deal with the cause of my convulsions she will be treated as if she intended the consequences. when doctors turn off the respirator, they are doing so in a context where they are not abandoning their duty of professional care. they can do no more for the person. the patient will not get better with or without the machine, though they might live for quite awhile if they machine is left on. imagine, however, a different story. the patient is 20 years old. due to lung.damage from an accident, she needs a respirator. yet, she has a life. she is enrolled in college, has many friends, and is a whiz at video games. if you were her doctor and unilaterally pulled the plug on her, you would be held responsible, likely for homicide. pleading that you just "let nature take is course" would be unavailing. in short, a simplistic act-omission analysis does not help us gain clarity in the world of end-of-life care. 96. common-law recognized the right to withdraw treatment under considered medical judgment. dana elizabeth hirsch, euthanasia: is it murder or mercy killing? a comparison of the criminal laws in the united states, the netherlands, and switzerland, 12 loy. l.a. int'l & comp. l. rev. 821, 825 (1990) (compiling applicable cases). interestingly, as of 1995, withdrawal of food and hydration was more accepted in acute care hospitals than nursing homes. alan meisel, barriers to forgoing nutrition and hydration in nursing homes, 21 am. j.l. & med 335 (1995). 97. the significance of refusal or withdraw! oflife-sustainingtreatment during end~f-life care in the day~to~day operations of our medical institutions cannot be understated. eighty percent of us will die in hospitals or nursing homes. see cruzan, 497 u.s. at 302. this is ·less surprising when one realizes that on average, eighty days out of the last year of one's life is spent in a hospital or nursing home. peter g. filene, in the arms of others: a cultural history of the right to die in america 55 (1998). most of these deaths will be the result 72 indiana health law review [vol. 3:43 killing. hence the equal protection claim. and when one reviews basic principles of the criminal law, this position surely has some merit. as every student in first year criminal law knows, if i come upon my worst enemy lying on the ground in his death throws resulting from a mortal wound administered by another, and i put a bullet in his head, i am guilty of murder.98 every moment of life has equal value in the eyes of the criminal law. from this, one fairly might wonder why, if a d9ctor withdraws artificially provided food and hydration from a dying patient (who is not in the final phase of dying where withdrawal will not accelerate death), and this shortens his or her life, the doctor is not similarly considered liable for an intentional killing. the fact that analytically there may be no difference under criminal law principles between delivering the coup de grace to my enemy and pulling the plug, and therefore a fortiori between intentional self-killing and pulling the plug, does not mean that these different situations cannot rationally justify different treatment. analytic equivalence does not mean that the two situations cannot be distinguished on policy grounds. thus, pulling the plug, taking place as it does within the narrative of the deathbed, is so different from the narrative of the intentional street killing that we can treat the two situatio1_1s differently without any concern that how we deal with one will affect bow we culturally view the other. but i am not talking about condoning shooting people on the streets. rather, i am talking about very sick people ending their own lives. therefore, the question thus focuses on the rationality of treating pulling the plug differently from assisted self-killing. in the first place, most people currently do not equate pulling the plug with pas. and in considering policy, how we talk and think about things is important. 99 of course, just because the majority of people may think a certain way does not make it correct. on the other band, taking as one's initial path an existing line which also happens to be the one of least resistance, certainly seems a reasonable approach for a policy maker. in fact, it has been posited that it is only through holding the line between pulling the plug on one band, and assisted suicide on the other, that medicine has managed to keep the scrutiny of courts out of the former.100 of treatment decisions. see paul j. zwier, supra note 27, at 224, seventy percent of these decisions will involve withdrawing treatment. george p. smith, ii, restructuring the principles of medical futility, ii j. palliative care 9, 9 (1995); marcia angell, helping desperately ill people to die, in regulating how we die, supra note 68, at 12. a somewhat different estimate (though limited to hospitals) states that fifty percent of deaths in hospitals from non­ emergency cases result from withdrawing life saving treatment. final act, supra note 95, at i 0. 98. john a. robertson, involuntary euthanasia ofdefective newborns: a legal analysis, in death-dying,supranote 95, at 163; danielmaguire,deathbychoice 31,49 (1973); hircsh, supra note 96, at 833, 834; cf. gerald dworkin, rg. frey & sissela bok, euthanasia and physician-assisted suicide-forand against 24,29 (1998). 99. david orentlicher, the legalization of physician assisted suicide: a very modest revolution, 38 bosr. l. rev. 443, 445 (1997); cf. dworkin, supra note 33. 100. vanzyl,supranote28,at 124-25; yale.kasimar, the right to die: ondrawing(and eraring) lines, 35 duq. l. rev. 481,495 (1996). 2006] my father, john locke and assisted suicide 73 in the second place, pulling the plug takes place within a narrow range of time, place, and circumstances: a hospital, a dying patient (i am not concerned in this article with those in persistent vegetative states) dependent on a machine, with a few days or hours to live. suicide, even for the terminally ill, can cover a far broader scenario of time, place and circum­ stances. and society, therefore, may reasonably hesitate before it expands the right to terminate innocent lives within this far less cabined area of assisted suicide. of course, one does not have to accept this analysis, and may well come up with reasonable counterargum.ents to my position. saying that i am incorrect, however, is leaps and bounds from labeling my position as totally irrational. categorizing pulling the plug differently than from sase fulfills the very hands-off standard of minimum rationality. 3. refusing lifesaving treatment · assisted suicide advocates contend that there is no rational distinction between letting someone refuse lifesaving treatment, knowing that that decision will likely lead to death, and affirmatively ending his life through assisted suicide. but, is that correct? imagine a person who is given the following choice: undergo painful surgery followed by painful therapy and lingering in pain afterwards, or die. if the person says n:o, has she committed suicide? i could, of course, define suicide broadly so as to include any deliberate action which we know reasonable likely to lead to one's death-war hero rushing a bunker, heavy smoker, extreme sport enthusiast. in that case, both suicide and refusing lifesaving treatment would be the same. but i think it makes more sense to define suicide to coincide more with our narrative sense of the act, an intentional destruction of self. thus, if the war hero who rushes the bunker miraculously lives and says "thank: god," it is not a suicide attempt. if he finds himself still standing and is disappointed to be still alive, his rush on the bunker was a suicide attempt. i suppose one could argue that psychologically there is a sense of self­ destruction, for example, in the case of the heavy smoker who one can say is committing slow motion suicide. and again if they do not die and are disappointed, then it was in fact a suicide attempt. yet, i hesitate to define suicide so broadly so as to include the average smoker. if self-destructiveness were the only criteria, then given the ·existence of wars, nuclear weapons, pollution, destruction of species, depletion of resources, the green house effect, and such, our whole human race could be characterized as suicidal. so, let us return to our patient who is facing an agonizing choice of painful surgery, painful recovery, and painful life, or likelihood of death from non-treatment. her refusal of treatment would only fit my sense of suicide if she refused treatment, somehow lived (perhaps being misdiagnosed), and then was despondent that her life did not end. 14 indiana health law review [vol. 3:43 that does not end the analysis of these grounds, however, but only really begins it. for even if refusing life-saving treatment is not invariably the equivalent of suicide (though in a particular caseit may be), it still permits a patient to choose to end his or her life. the question then comes back to whether there are rational policy grounds101 for letting patients refuse treatment, knowing that decision means death, while denying the ability to intentionally end their lives to those patients not dependent on lifesaving treatment. one initially must recall. the legal underpinnings of this so-called right to refuse treatment. it combines the notion that one has the right to be free of what the law calls. a battery ("harmful and offensive, touching),102 with the related notion, within the medical sphere, of informed consent.103 again, this latter concept is an attempt to ensure that patients have sufficient information to make good choices about their treatment, and is an aspect of a patient autonomy movement which, in part, reflected a loss of confidence and trust in the medical profession. the law of battery, however, does not leave room for one to consent to a battery; i.e., i cannot give someone my permission to hit me. obviously, we do have exceptions for certain sports (e.g., boxing, football and hockey). yet even as to these, the violence must be circumscribed by the contours of the sport (hitting someone in the head with a hockey stick as they are entering the penalty box can result in criminal charges). the law of battery thus not only is intended to protect me individually, it attempts to define a non-violent society. within this body of law, medical procedures such as surgery and shots may be consented to because, though often painful and unpleasant, they are not considered harmful and offensive. in filet, we want doctors to do that type of thing. to do it against our wishes, however, is quite a different matter. that is an offensive touching. now consider social policy. imagine that there was no right to refuse treatment. first, there could be extraordinary invasions of the person of the 101. thus, even if we may not be able to distinguish refusing treatment from suicide morally, we can distinguish between the two as a matter oflegal policy. sanford h. kadish, letting patients die: legal and moral reflections, 80 cal. l. rev. 857,867 (1992). 102. schloendor:ff v. soc'y of new york hosp., 105 n.e. 92 (1914) (cardozo, j.), abrogatedbybingv. thunig, 143n.e.2d3(1957); inreconroy,486a.2d l209(n.j.l985); bouvia v. superior court, 255 cal. rptr. 297 (cal. ct. app. 1986). see also hircsh, supra note 96, at 828. q: joan m. gilmour, withholding and withdrawing life support from adults at common law, 31 osooodehalll. j. 473,480 (1993) (providing analogous bodyoflaw in canada). i 03. some have questioned the efficacy of informed consent; steven miles, dem.etris m. pappas, & robert keopp, considerations of safeguards proposed in laws and guidelines to legalize assisted suicide, in physician-assisted suicide, supra note 31, at 209; gilmour, supra note 102, at 481-82 (stating in reality, "informed consent" will devolve to a matter of doctors convincing patient's to accept the doctors' recommendations). 2006] my father, john locke and assisted suicide 75 individual. 104 the image of someone holding down and dragging a screaming patient to surgery to amputate his leg over his violent protests is not an attractive one in a society so sensitive to individual liberty and autonomy. second, people would hesitate to go to hospitals (i know i would), even if they really needed to go, for fear of finding themselves held against their will as "prisoners of pain."10s on the other hand, to refuse to let someone intentionally kill herself is not similarly intrusive {i'm not imagining tackling someone and ripping a gun from her hand, but rather a more medical context). we are just denying the means of death to that person; we are not forcing anything on her. the counter argument to this is that i am wrongly assuming that there is no harm in forcing someone to live under any circumstances. this assumption was at the base of the logic of the supreme court in cruzan. 106 underlying the court's decision in that case, which involved pulliitg the plug on a young woman in a persistent vegetative state ("pvs"), was the court's implicit assumption that ending her life mistakenly was a great harm, while mistakenly forcing her to exist was no harm. this is a logic which many say is misguided, even when dealing with a persistent vegetative state as in cruzan. when we are dealing with someone like my father, the argument that there is plainly a great harm in making a very ill, suffering person continue to live is clearer. while i agree with this argument, i, again. cannot say that the position that there are distinctions justified by social policy between assisted suicide and refusing lifesaving treatment is an irrational one. further, it is not clear that even the right to refuse lifesaving treatment itself is legally inviolable when it comes to someone clearly attempting suicide. imagine a twenty~year old who is suffering from a strange enzyme deficiency. if he takes a pill once a month, he will live a healthy life with no 104. yale kamisar, physician assisted suicide: the lost bridge to active voluntary euthanasia, in euthanasia examined, supra note 31, at 248, 249; frances m. kamm, physician-assisted suicide, euthanasia, and intending death, in expanding 1he debate, supra note 19, at 40; yale kamisar, reasons, supra note 21; yale kamisar, drawing (and erasing) lines, supra note 100, at 492. in fact, some refuse treatment when the cure is worse than the disease. see submission to select committee of house oflords on medical ethics by thelinacre centre for health care ethics, in clinical practice, supra note 52, at 63. cf. man:ia angell, helping desperately ill people to die, in regulating how we die, supra note 68, at 12. 105. several state courts have articulated a constitutional right to refuse treatment. see, e.g., state v. mcmee, 385 s.e.2d 651 (ga. 1989); in re quinlan, 348 a.2d 801 (n.j. 1975); gray v. romero, 697 f. supp. 580 (1988). see also larry gostin, the right to choose death: the judicial trilogy of brophy, bouvia, and conroy, 24 law med. & heal til care 198, 199 (1986); thomas a eaton & edward j. larson, experiments with the "right to dill' in the laboratory of the states, 25 ga. l. rev. 1253 (1991). 106. some have criticized the failure of the cruzan majority to recognize that there may be harm in forcing a patient to continue to live. see cruzan, 497 u.s. 261, 320 (1990) (brennan, j., dissenting); joel feinberg, 'ihe moral limits of 1he criminal law: haltm to self 367-68 (1986); kadish, supra note 101, at 874. 76 indiana health law review [vol. 3:43 side effects. if he goes six weeks without a pill, he will suddenly collapse and die. one day after breaking up with his girlfriend, he announces that he will no longer take his pills. i do not believe we would simply let him die ("oh well, that is his legal right to refuse lifesaving medical treatment.") it is possible that a court might hesitate to pronounce that the right to refuse treatment cannot carry the day in this instance, fearing what to do when the next case comes and it is a weekly shot accompanied by flu-like symptoms, or amputation of several fingers on one hand, and so forth. but i believe the government will act to stop the young man from killing himself even though he is doing so under the banner of the right to refuse treatment. likely the government would take the competence route, find psychiatrists to testify about the young man's depression from the loss of a loved one, perhaps seek to appoint a guardian, etc. further, even if a court addressed the right to refuse treatment directly head on in this scenario, and nevertheless, ordered the pills forcibly107 administered, it is not clear to me that the judgment would subsequently be reversed on appeal. in a claim sounding in autonomy (i.e., that compulsory vaccination ''violates the inherent right of every freeman to care for his own body and health in such a way as to him seems best"), the supreme court nevertheless held that adult citizens are not permitted to refuse to be vaccinated against a disease threatening the public, such as a small pox epidemic.108 similarly, jehovah's witnesses, whose first amendment rights to religious freedom allow them to refuse blood transfusions even at the costs of their lives are not permitted to refuse similar transfusions on behalf of their minor children.109 public health and safety issues surpass religious freedom in that case. additionally, prisoners who go on hunger strikes, even when done as a means of first amendment expression, can be force-fed and hydrated.110 their right to refuse treatment is overbalanced by the state's paternalistic responsibility for their lives 111 and its interest in order and security in the prisons. likewise, in a prison setting, a showing that an inmate has a mental illness which may cause him to hurt himself or others can justify forced . administration of antipsychotic medication in spite of the prisoner's 107. courts have forced patients to undergo treatment. see gilmour, supra note 102, at 484 (citing earlier cases where, e.g., the patient had parental responsibilities); meisel, supra note 96, at 365 n.l83 (stating patient not competent to make the decision). 108, jacobson v. mass, 197 u.s. 11,24-30 (1905). 109. jd. at 26; orentlicher, supra note 99, at 458. see, e.g., jehovah's witnesses v. king county hosp., 278 f. supp. 488 (w.d. wash. 1967) aff' d, 390 u.s. 598, rehearing denied, 391 u.s. 598 (1968). 110. joel k. greenbert, hunger striking prisoners: the constitutionality of force­ feeding, 51 fordham l. rev. 747 (1983). see also d. sneed & harry w. stonecipher, prisoners fasting as symbolic speech: the ultimate speech action, 32 how. l.j. 549 (1989). 111. prisoners thus cannot refuse life-saving treatment greenberg, supra note 109, at 11, 14. (noting prisoners can be forced to take insulin, undergo dialysis). see also arlene mccarthy, annotation, prisoner's right to die or refuse medical treatment, 66 a.l.r.5th 111 (1999). 2006] my father, john locke and assisted suicide 77 fundamental liberty interest in avoiding forced administration of such drugs. 112 the point is that even given a right to refuse treatment, it appears that at times the interests of the state may weigh more heavily in the balance.113 moreover, even the exact nature of the so-called constitutional right to refuse treatment is far from clear. the supreme court discussed the possible constitutional nature of the right to refuse treatment in the cruzan case.114 nancy cruzan was in a persistent vegetative state.11s her family wanted to pull the plug, however, the state refused to allow this, creating a case about substituted judgment.116 the issue before the supreme court concerned the magnitude of the burden of proof the state was entitled to place on the parents to establish that nancy would not want the treatment. 117 the court initially acknowledged that there was an established common-law (case law, as opposed to statutory or constitutional) right to refuse medical treatment. a common law right, however, is not the same as a constitutional right, which thereby would bind the state and federal governments.118 the cruzan court then discussed the possible constitutionality of the right to refuse treatment by stating that a "constitutionally protected liberty interest .... may be inferred from our prior decisions."119 but in support of this proposition, the court cited the jacobson case, the very case in which the state's interest .in forcibly (if necessary) administering a smallpox vaccine trumped the right to refuse treatment by a citizen who was basing his claim on autonomy-resonating grounds. right from the start, the court implicitly stated that even if there is a constitutional right to refuse medical treatment in a particular situation, the state's interests in a particular situation may outweigh the individual's exercise ofhis right. the court went on to note that the logic of past cases would give one a constitutional right to refuse even lifesaving treatment. 120 the court, however, then added that the "dramatic consequences involved in refusal of such treatment would inform the inquiry as to whether the deprivation of that 112. wash. v. harper, 494 u.s. 210 (1990). 113. society tends to display its paternalism when it comes to lifesaving. robert m. byrn, compulsory lifesaving treatment for the competent adult, in death-dying, supra note 95, at 706; in re conroy, 486 a.2d 1209 (n.j 1985); bovia v. superior court, 225 cal. rptr. 297 (cal. ct. app. 1986). and, as we all know, society does at times act paternalistically and forbid us "for our own good" ftom doing certain things. joel feinberg, 'die moral limits of nm criminal law: harm to self 24 (1986) (distinguishing assisted suicide ftom reproductive rights). 114. cruzan, 497 u.s. at 270,277. 115. /d. at 266. 116. id. at 267 117. id. at 265, 280-281 (finding that a burden of .. clear and convincing evidence" was constitutionally permissible). 118. ld:at267,277. 119. cruzan, 497 u.s. at 278. but for this proposition, the cruzan court cited jacobson v. mass., 197 u.s. ii (1905) (:finding the state's interest in public health and safety outweighed the citizen's interest to care for her body as she sees best). 120. cruzan, 497 u.s. at 279. 78 indiana health law review [vol. 3:43 interest is constitutionally permissible."121 again, even if we afford such a constitutional right, given the ultimately serious consequences, the state's interests in a particular case may justify "the deprivation of that interest." further, the court always refers to this right as a "liberty interest," never as a "fundamental right."122 within the equal protection level of scrutiny game, this characterization could dictate the outcome in most cases in which the state seeks to oppose the exercise of such a right, since the term liberty interest may be taken to mean that a lesser state interest can overcome the right than if it were characterized as fundamental.123 justice scalia, in a separate opinion, even said that the state could always forcibly prevent suicide (keep from slashing wrists, pump poison out of stomach), and that that included circumstances when refusing lifesaving treatment was the means to that end. 124 on the other hand, the use of the phrase liberty interest does not necessarily mean rational basis scrutiny. in glucksberg, where the court upheld the constitutionality of a state statute barring assisted suicide, the court said that due process requires heightened scrutiny for certain "fundamental rights and liberty interests."12s does this refusal oflifesaving treatment violate one of these certain liberty interests? this takes us back to square one. supreme court cases are filled with language which each side will pounce on and try to exploit to their advantage. this phrase in glucksberg is just one more instance of such words. all that this article has previously discussed regarding counter-balancing state interests with the constitutional right of the individual to refuse lifesaving treatment has assumed that there was such a constitutional right in the first place. this is just what the court in cruzan did, assume. "but for purposes of this case, we assume . . . the united states constitution would grant a competent person a constitutionally protected right to refuse lifesaving hydration and nutrition. "126 the court could make this rhetorical move because whether or not a conscious,· competent nancy cruzan had a constitutional right to demand that her tubes be pulled and the machine silenced was not the issue. there was no such nancy cruzan. the only issue before the court was what burden the state was entitled to put on her family to establish, in some form, what nancy's wishes would have been. to say that 121. id. 122. /d. at279n.7; yalekamisar, when is thereaconstitutional"righttodie?" when is there a constitutional "right to live"?, 25 ga. l. rev. 1203, 1229 (1991). 123. john a. robertson, cruzan and the constitutional status ofnontreatment decisions for incompetent patients, 25 ga. l. rev. 1139, 1172-73, 1176-77 (1992). 124. cruzan, 491 u.s. at 293. the state can forcibly prevent someone from committing suicide, even if in the guise of refusing treatment. /d. see also annette e. clark, autonomy and death, 71 'tulane. l. rev. 45, 72-73 (1996). 125. glucksberg, 521 u.s. at 721. 126. cruzan, 491 u.s. at 279. cruzan indicated that a competent person has a liberty interest under the due process clause that must be balanced against state interests. id. cruzan was not about suicide or assisted suicide; again it was about the burden a state oould use for a determination regarding substituted judgment. id. at 280. 2006] my f a'iher, john locke and assisted suicide 79 by making the task of proof very difficult, the state implicitly interfered with nancy's exercise ofher right, and therefore necessarily involved consideration of that right, confuses the question that the·court actually faced. rather, the question in cruzan concerned the legitimate way to determine (or perhaps more accurately, make up) when a person like nancy could be said to exercise such a right if she had it.127 it is true that five justices, counting the majority and dissent, wrote in favor of such a constitutional right. 128 · because a determination about the constitutional nature of the right to refuse treatment was not necessary to the court's decision in favor of the state, however, under clearly established principles regarding the precedential import of statements in a case unnecessary to the decision (i.e., dicta), such statements are not law.129 (nancy's case was subsequently sent back to the state where friends came forward who recalled past conversations with nancy, indicating she would wish to refuse treatment under her present circumstances. as a result, after more legal proceedings, nancy was allowed to die). 130 when the cruzan case was discussed in glucksberg, the supreme court noted that cruzan had "assumed and strongly suggested" that the right to refuse lifesaving treatment had a constitutional underpinning.131 it is also correct that the court then went on to characterize cruzan as based on the long-established right to refuse treatment.132 therefore, one might claim that glucksberg at last established the constitutional nature of the right. while one could plainly make this argument, it is merely just an argument. opponents to this argument will likely respond by saying that the refusal of medical treatment is a long-established right; the court merely acknowledged the unquestioned common law application of the law of battery in the medical context. also, this discussion in glucksberg is total dicta and therefore of no precedential value. deciding whether or not an individual has the right to refuse lifesaving medical treatment was not necessary for the court to reach . the decision in glucksberg that the same patient does not have a constitutional right to have a third person help him commit suicide. again, we are faced with the same lesson. as has been previously stated, the law cannot be looked to for stable, predictable outcomes in an area such as this where there is such an intense underlying moral and social policy 127. the cruzan court focused upon whether the state could make nancy cruzan's family prove by "clear and convincing evidence" that their daughter would not have wanted to be kept alive in a persistent vegetative state through artificial feeding and hydration. cruzan, 497 u.s. at 277. ("in this court, the question is simply and starkly whether the united states constitution prohibits missouri from choosing the rule of decision [i.e., burden on parents of 'clear and convincing' evidence] which it did."). 128. cruzan, 497 u.s. at 331. 129. wolf, physician-assisted suicide, supra note 31, at 170 ("cruzan of course recognizes a liberty interest only in dicta."). 130. filenes,supranote 97, at 181-82; palmer, supra note 21, at41-42. 131. glucksberg, 521 u.s. at 720. 132. id. at 720, 723. but see lund, supra note 8, at 872 (questioning whether any of this is a part of a long-standing tradition in medical care). 80 indiana health law review [vol. 3:43 debate. admittedly, this was also the circumstance when the supreme court unanimously found racial segregation in public education unconstitutional in brown v. board of education. 133 surely, the court faced a far more powerfully divisive issue than the assisted suicide debate, yet the court was capable of stepping in and dismantling jim crow.134 i agree; yet there are fundamental differences between the issues. while denying suicide or assisted suicide may be said by some to be wrong, its denial does not seem deeply, fundamentally immoral. racial segregation was deeply, fundamentally immoral. that is, i believe, why the court ruled as it did in brown, not because of any imprimatur from the phrase equal protection. that same phrase, after all, with the same available tools of legal interpretation, had, up until then, resulted in a legacy of"separate but equal."135 4. terminal sedation an awareness of a medical procedure called terminal sedation has only recently entered the national debate over suicide and assisted suicide. 136 technically, terminal sedation involves rendering a patient unconscious with some drug (which itself could result in death, though justified by pde). this sedation then is · commonly accompanied by withdrawing food and hydration. 137 the latter aspect of the procedure is what makes it terminal.138 currently, terminal sedation is used as a last resort where other methods of pain control have proven ineffective. 139 since a healthy person would die if rendered unconscious and then denied food and water, this procedure can 133. brown, 347 u.s. at 483. 134. so-called "jim crow" laws, which separated blacks and whites in all aspects oflife, emerged in the southern states following the civil war. 6 west's encyclopedia of american law 13 (2d ed. 2004). 135. see; e.g., plessey v. ferguson, 163 u.s. 537 (1896) (upholding louisiana statute requiring railroads to provide equal, but separate accommodations for whites and blacks). 136. bernard gert, charles m. culver, & k. danner clouser, an alternative to physician­ assisted suicide, in expanding the debate, supra note 19, at 182; john d. arras, tragic view, in expanding the debate, supra note 19, at 294; balfour m. mount & pat hamilton, when palliative care fails to control suffering, 10 j. p aujative care 24, 25 (1994); marion d. cooper, commentary, when palliative care fails to control suffering, 10 j. pau.iative care 27, 27 (1994); gillian m. craig, on withholding nutrition and hydration in the terminally ill: has palliative medicine gone too far?, 20 j. med. ethics 139, 140 (1994); diloreto, supra note 67, at 69. 137. diloreto, supra note 67, at 69-70; david orentlicher, the supreme court and terminal sedation: rejecting assisted suicide, embracing euthansia, 24 hast. const. l.q. 947,955 (1997). 138. raanan gillon, palliative care ethics: non-provisions of artificial nutrition and hydration to terminally ill sedated patients, 20 j. meo. ethics 131, 131 (1994). 139. mount & hamilton, supra note 136, at 26 (indicating sedation only to be used if other methods to relieve suffering have failed). 2006] my father. john locke and assisted suicide 81 appear indistinguishable :from assisted suicide; 140 however, part of this is a function of the narrative associated with the procedure. using it on a dying patient whose pain is out of control, and during the last few days of his or her life, seems little different than other life terminating medical responses at the end of life that have been previously discussed.141 on the other hand, the less the pain and/or the longer the life expectancy, the closer this technique inches towards, and eventually becomes, an intentional killing. unlike suicide, on the other hand, the sedated person can be revived before death. on a practical level, this means that the patient can be brought back to consciousness for, e.g., a half-hour a day, during which time he can talk to his family until the pain gets out of control and he must be sedated again. on a theoretical plane, the capacity to revive gives the opportunity to administer the mythological eleventh hour miracle cure. also, death in effect comes :from a refusal of lifesaving treatment (artificial feeding and hydration) which, as we have already discussed, can at least in rational basis be distin­ guished :from suicide. within the world of the "death with dignity'' and the "right to choose the time of one's death" movements, however, terminal sedation is a funny animal. lying unconscious in what is the drug-induced equivalent of a coma would seem to represent the very type of image those in this movement find undignified (though here, while medical science has put one in that state, it is not bent on keeping one alive in it). additionally, one does not really control the time of death as assisted suicide advocates desire because how long one continues living in this unconscious state will not be a function of conscious plans, but rather a function ofhow long the body and primitive brain will take to break down without food or water. in any event, from the perspective of social policy, one can rationally place terminal sedation in a different category than intentional tennination. when discussing pde, it was recognized that this rationale for high risk taking with a patient's life, in contrast to assisted suicide, can only apply to a relatively narrow, circumscribed set of patients. that is even more so for the accepted narrative to which terminal sedation is considered. these are people who are not only in such great physical pain that they must be given drugs carrying the attendant risk of death such as morphine (as· was the case with pde). they are so far on the extreme side of the pain spectrum that no amount of medication can control their agony while they are conscious. this is indeed a small and identifiable group of patients. it is also the group that the vast majority of americans would approve letting a doctor help to die in order 140. orentlicher, terminal sedation, supra note 137,at953-958 (1997); ld. at959(stating sedation prevents saving patient who has been misdiagnosed. because will die anyway from starvation); arras, tragic view, in expanding the debate, supra note 19,at 300 (stating that terminal sedation even worse than pas); david orentlicher, the supreme court and terminal sedation: an ethically inferior alternative to physician-assisted suicide, in expanding the debate, supra note 19, at 301. 141. see supra parts u.b.1-3. 82 indiana heallh law review [vol. 3:43 to end the suffering. again, the distinction is surely a rational one. ill. john locke, cmc republicanism, and the real constitutional right to assisted suicide "we the people, in order to fonn a more perfect union ... " is a direct expression of the political theory provided in the social contract of john locke. 142 while the social contract theory had appeared in writings on political philosophy for over a hundred years before the formation of this nation, only america took to heart locke's theory, and its accompanying journey out of. the mythical "state of nature," to actually structure the government of a new nation. 143 our constitutional enterprise, thus, consciously based its nature and legitimacy on the social contract theory of that seventeenth century english philosopher. 144 this theory sets the parameters of responsibility between the state and the individual: what does the state owe the citizen? what does the citizen owe the state? in the discussion which follows, the conclusion is reached that under the social contract theory, someone my father's age does not owe the state any duty which would pennit the state the right to interfere with his decision to end his life. this is particularly so when an individual is too ill to ever again be capable of participating in political life; thus, rendering them not able to demonstrate the civic virtue that those constitutional founders espousing the philosophy of civic republicanism brought to the constitution as a means aimed at modifying the extreme individualism of locke. a. the social contract theory according to the underlying narrative of the social contract theory, back in the mists of time, man lived in a state of nature.145 in this world, each 142. gardner. supra note 17, at 207-08. see also id. at 193 ("[t)he united states government derives its legitimacy, in the lockean sense, from the consent of the governed."); robert paul wolff, about philosophy 123,127,129(1976)("wecall it our constitution, but what the founding fathers actual1ywrote was the first operative social contract ..• [with] john locke [thus being] the spiritual tather of our constitution •• . j. q: daniell. morrissey, bringing the messiah through law: legal education at the jesuit schools, 48 st. louis u. l.j. 549, 559 (2004) (providing an analysis that attributes the development of the theory of social contract to jesuit philosophers). 143. see thomas l. pangle, the spirit of modern repu8ucanism: the moral vision of the american founders and the philosophy of locke 123 (1988) [hereinafter spiritofmodernrepubucanism]; see thomas l. pangle, the philosophical understanding of human nature in forming the constitution. in confronting the constitution: the chau.enge to locke, montbsquieu, jefferson. and the federausts from utiutarianism, historicism, marxism, freudianism, pragmatism, existentiausm 37 (allan bloomed., 1990) [hereinafter confronting the constitution]; wolff, supra note 142 (stating locke was the "spiritual tather of the constitution''). 144. ld. 145. locke,supranote 17,at8. 2006] my f a1her., john locke and assisted suicide 83 individual had natural rights revealed by our .capacity for reason. 146 but each person was his own law with respect to asserting and protecting these rights, with force as the final arbiter. 147 in other words, people possessed a great deal of freedom, but not much security. to gain the security an organized society would provide for their lives and property, people were willing to leave the state of nature and with it, their unappeasable right to be the ultimate law148 (although, in theory, those against whom they imposed ''their law" could take a final appeal to the will of god).149 in this bargain for security, one gave up the right to make the rules for day-to-day life, leaving that to a representative body which itself was subject to law.150 all disputes, thus, were ultimately to be decided by the law, not by individual will. in the bargain, however, no person gave up his natural rights (life, liberty, property). as expressed in the declaration of independence, "[we] are endowed by the creator with inalienable rights ... ,"u1 rights which cannot be taken by government or bartered to it. the lockean and related natural law notions (as distinguished from the "law ofnature," which is not normative but merely descriptive of how nature actually operates) directly guided the construction of our constitution and our form of govemment.152 these theories even played an explicit role in early supreme court decisions.153 after·all, several early justices were present at the creation of this nation. they knew that they bad embarked upon a great new political experiment in government. it was a nation simultaneously of the people, by the people, and for the people. time has obscured this philosophical foundation of our government, or at least led us to think of only the trees of the constitutional text and not the underlying forest of political philosophy. yet the theory of the social contract lies at the basis of the very legitimacy of our government.154 146. locke, supra note 17, at 9 ("the state of nature has a law of nature to govern it, which obliges everyone: and reason, which is the law, ... ");spirit of modern repubu­ canism, supra note 14, at 149, 199; confronting tile cons'i'itimon, supra note 14, at 10. 14 7. locke, supra note 17, at 11 ~ 12; frank d. balog, the scottish enlightenment and the liberal political tradition, in confronting tile constmmon, supra note 143, at 202. 148. see loci(e, supra note 17, at 16, 53, 66; see also gardner, supra note 142, at 202. 149. locke, supra note 17, at 16, 53, 66. 150. see locke, supra note 17, at 7~71,111 (arguing that government is obligated to protect property, including one's life). 151. for a text reprinting the declaration of independence, see "organic laws," 1 u.s. code, at xliii (200 1 ). 152. spirit of modern .repu8ucanism, supra note 143, at 34; tribe, supra note 14, at 561; donaldl. doernberg, "wethepeople":john~collective constitutional rights and standing to challenge government action, 73 cal. l. rev. 52, 52 (1985); gardner, supra note 142, at 197-98; see locke, supra note 17, at vii. see generally confronting tile constitution, supra note 143. 153. natural rights theory thus appears in early united states supreme court cases. see, tribe, supra note 14, at 561, 562; gardner. supra note 17, at2l~ll. 154. see gardner, supra note 17, at 193 (acquiring legitimacy based on consent of governed); see casey, 505 u.s. at 90 i ("'ur constitution is a covenant running from the first generation of americans to us and then to futule generations."). cf. generally locke, supra 84 indiana health law review [vol. 3:43 our government was not founded on the divine right of kings or conquest. tss its legitimacy was based on the belief (treated as fact) that the citizenry had entered into a contract. 156 under the terms of that contract, the citizenry ceded its law-making power, transferring it to a representative government. that power which was transferred power, however, was limited by the people's inalienable natural rights and by the very purposes for which the institution of government was created (e.g., protection of life, liberty and property). as any contract has reciprocal obligations, the question becomes: what do we owe our society? (note that the question is not what we owe the government. under locke, one has no obligation to the government. the obligations are to the other contractors, the body politic, the society. )157 the answer to this question will directly impact the rights of people like my father at the end of his life. since, according to the theory of social contract, a primary motivation for entering into that contract was to obtain physical security not available in a world where the state of nature tended to degenerate into a "state of war,"158 we reciprocally would seem to owe society our availability for protection against aggressors ''to provide for the common defence. "159 consistent with this obligation is the fact that under our current law one must obtain permission to renounce citizenship in time ofwar.160 in short, our society does not have to let a citizen out of the social contract if the nation needs his help in defense.161 of course, since children are not automatically bound to a contractto which they did not agree, they, like their parents before, note 17, at xxi ("the confluence ofhis [locke's] main lines of argument about government and about property rights provide an eminently useable ideological underpinning for the modern liberal capitalist state.''). 155. wolff, supra note 142. at 121. (''theunqualifiedclaimofabsolutekinglyauthority [based on the notion that the king was god's representative on earth] was unacceptable to the philosophers of the enlightenment. j; locke, supra note 17, at 92 (founding nation by conquest). 156. of course, a marxist would call all this revisionist rubbish, claiming that this government was instituted to protect the property and debts owed to major landowners. see w. r. newell, reflections on marxism and america, in confrontjnothe constitution, supra note 143, at 334. cf. wolff, supra note 142, at 140-41 (noting that for marx the evolution of modern society begins when very early in human history, one group of people merely grabbed the means of production by force). and it is true that locke does provide a philosophical justification for the accumulation and protection of private property and wealth. locke, supra note 17, at 27-30; pangle, the philosophical understandings ofhuman nature informing the constitution, in confronting thb constitution, supra note 143, at 43-46. 157. doernberg. supra note 152, at 61. 158. locke, supra note17, at 16 ("to avoid this state of war ... is one great reason of men putting themselves into society, and quitting the state of nature .•• j. 159. u.s. const. pmbl. ·160. formal renunciation of citizenship, 18b fed. prac. § 45-2166,2166 n.39 (1999). see also 8 u.s.c. §§ 1481(sx6) et seq. (west 2000). 161. in general, a person under lockean theory can always leave society. wolff, supra note 142. 2006] my father, john locke and assisted suicide 85 have the choice to reject its terms at the time they reach maturity. on the other hand, if they remain in the country after that age, and do not formally disavow the contract (i.e., renounce citizenship) they are bound by its terms. 162 society as part of the contract could also make an individual, or some "unit" that would agree to be responsible for the individual, to provide for the individual's material needs, and add to the productive capacity which is inseparable from a nation's capacity for defense. it is a fact that in our society (other than parents' obligation to serve as a unit supporting their children, whether married or divorced), people are not forced to assume this obligation. the government provides welfare and food stamps in certain instances. our society, however, does not suffer from extreme scarcity. if things were otherwise, the government could legitimately demand a reciprocal obligation of self-sufficiency, though it may not be the type of society in which one would wish to live. finally, the contract requires that individuals obey the laws. a major part of the agreement is that citizens give up their position as the ultimate law, reposing that power in a representative government that is itself subject to law. 163 to ignore the law created by these representatives breaks the bargain, usurping the lawmaking function which was relinquished. these laws, however, must be such that they can be legitimately enforced against us. they cannot exceed the power which was bargained away to this limited government. they cannot usurp natural rights. b. the social contract and assisted suicide the obvious question concerns the content, criteria, measure or such that defines when one can be said to have fulfilled his end of the bargain. at what point is one no longer obligated under the social contract to provide personal resources to the society and thus is free to end his existence? the criteria obviously cannot be reduced to some list to be checked off like some school project. what would even be on the list? nor could the criteria become quantum of contribution (i.e., so much wealth maximization, so much moral contribution in good deeds, so much service to the society such as in. child rearing); hardly a clear guideline for conduct, in fact, an absurd enterprise. society, however, does have a proxy for that time when one has fulfilled· her obligation to produce and protect. it is embodied in our concept of social 162. locke, supra note 17, at 41, 62-64; wow, supra note 142. ("to this, the social contract theorists answer that each of us, upon reaching the legal age of adulthood, implicitly signs his name to that original contract by remaining in the country, living under its laws, and entering actively into its legal arrangements."). 163. thus, the rights an individual gives up as part of social contract do not revert so long as society lasts; rather, they remain in the community. locke, supra note 17, at 123. but see id. at 107, ill, 123 ("of the dissolution of government"; when government violates the social contract). 86 indiana health law review [vol.3:43 security and the philosophy and history underlying that act.164 at a certain age, society permits a citizen to claim full social security benefits. this statement suggests that society believes one bas done enough. my selection of the retirement benefit section of the social security act as a proxy for when the social contract no longer demands one's presence as a producer or a defender is neither arbitrary nor fanciful. it is justified by both the history and philosophy underlying the retirement portions of that legislation. retirement connotes voluntary cessation of work at a specific age, as opposed to. stopping work because of disability. this idea that we can all expect to be able to retire, however, is a fairly recent phenomenon in history. the social security retirement system provided: [a] federal, mandatory, and public redistribution income base that made broad, voluntary middle-class retirement possible . . . the real distinction between social security and its predecessors was its role in institutionalizing retirement, along with the expectation of income support in old age, in order to meet the needs of an advanced industrial economy that was perceived to have more economic output than jobs. 165 the moral justification for this entitlement to a guaranteed future retirement above the level of poverty, was that the individual bad earned that retirement "on the grounds of age and prior service to the society and economy through work. ''166 entitlement to public benefits in the american tradition has always been based on a judgment of moral worth resulting from service to the country or other evidence of good character. the innovation of the social security system was to broaden the criteria for entitlement from military service to work in general. in this sense, the term "earned right" is an accurate description of the relationship between beneficiaries and benefits. 167 thus, at the requisite age, one is entitled to the means to voluntarily cease serving the nation. one does not have to produce anymore. one is no 164. forthehistoryofthe creation of the social security act. see ar111urjaltmeyer, the formative yearsofsoclalsecurity (1966); edwin e. widte, 1he development of nm social security acr ( 1962); patricia e. dilley, the evolution of entitlement: retirement income and the problem of integrating private pensions and social security, 30 loy. l.a. l. rev. 1063 (1997). 165. dilley, supra note 164, at 1140, 1193. 166. dilley, supra note 164, at 1080-1081, 1140. 167. jd. at 1080-81.. 2006] my father, john locke and assisted su1cide 87 longer required to guard our shores (unless, in some situation so extraordinary that has never been seen before in our nation's history, that literally every single citizen is needed to save us from total destruction by some aggressor). retirees are to relax and enjoy the benefits of their labor and loyalty. at that point, no more is owed under the contract; its terms have been fulfilled. one can even leave the society without any right of the government to interfere. a person should also be free to leave through terminating his or her life. 168 to require a seventy-or eighty-year-old go to some remote island or ice flow (since these are the only locales where they can be confident that they will certainly not be subject to another society's rules that are not based on the social contract) to end his life, makes a mockery of the contract. even in a less extreme scenario, such as forcing an individual to leave his home and the nation he has served in order to travel to a country where he can legally end his life (e.g., the netherlands), and then requiring that he work his way through the red tape and medical establishment of a foreign nation, violates any good faith interpretation of the social contract. at the point when a citizen has held up his end of the agreement by a lifetime oflabor, he owes no more. one concern regarding this particular invocation of the social contract that might be raised is that it devalues older citizens and puts them in the category of being disposable. however, the social contract theory is not saying that people over the age of retirement have some lesser value--quite the contrary. the ranks of the older and elderly are to be filled with wise, capable individuals with much to offer (although admittedly all may not share this view). in a culture so obsessed with momentary flash and image, the wisdom of age and experience is desperately needed to guide us through the media drenched morass in which we currently exist. increasingly, greater numbers of these older and elderly citizens (who will constitute a larger and increasingly larger portion of our population) will live beyond one hundred, and contribute much to family, friends, and society. the social contract analysis should be interpreted as saying no more than that which one owes 168. some might point out that, depending on when people are born, they will be eligible for full social security benefits at different ages. are some, therefore, only bound by the lockean contract until65, while others must wait until 67 or 67 -112? no. again, the concept of an age of retirement under social security is just circumstantial evidence, a rough measure of our national attitude towards those who have done their share. the precise difference among different retirement dates, on the other hand, reflects demographics and budget constraints rather than a metaphorical line for fulfilling one's side of the social contract. therefore, heel it reasonable for constitutional purposes to select the earliest age any group of citizens are eligible for full retirement as the age when the social contract no long binds our lives to the state. to the extent that social security benefits are given to children who have lost parents and those too mentally or physically disabled to work, these are more in the realm of social service payments, than the recognition that one has come to the time when they may cease to labor. of course, if our society totally eliminated social security, that would not mark the demise of my lockean theory. i would just have to search for an alternative bright-line proxy for when a person has fulfilled his or her obligations. 88 indiana health law review [vol. 3:43 society is limited, and preserving one's life after the age of retirement is not one of those things owed. of course, one may question whether this line of reasoning can really be limited to those over the age of retirement under the social security system. could not a thirty-year-old take this argument and say, "look, i could renounce my citizenship and emigrate if i felt like it-except in the time of war-so what's the big deal if i kill myself? it all comes out the same as far as this country is concerned." the answer, according to this theory, is that even if there is a legal path (i.e., renouncing citizenship) to remove one's self from the nation's human. resources prior to the official age of retirement, it does not mean that society wants an individual to leave. renouncing citizenship and emigrating is a.time consuming, complex process, which most people are not likely to do. committing suicide, on the other hand, is fast and easy. if one is a person under the age of retirement, few resources are risked if we permit the former, but not the latter. we do not want to make suicide easy. therefore, the line is drawn at age of retirement. there are, however, implications of this analysis over which i admit feeling a certain amount of discomfort. if one is over the age of retirement, one can kill one's self whether or not the individual is sick or healthy, clinically depressed or merely bored, in severe pain or just acting on a whim, and the government can do nothing about it. the older and elderly are the very population which is most likely to encounter coercion, abandonment in public institutions without access to any palliative care, and all the other concerns which lie along what in the public debate over assisted suicide has been termed the slippery slope. the answer to this dilemma can be found in the second philosophical underpinning of our government-civic republi­ canism. c. enter civic republicanism though the social contract was the primary philosophical foundation for the new government and constitution, it was not the sole theory in the mix relied on by the founders. a second theory, civic republicanism,169 was needed to counterbalance lockean individualism.170 this theory significantly restricts the pool of those contemplating suicide with whom the government cannot constitutionally interfere. the philosophy of civic republicanism revolved around the notion of civic virtue.171 citizens, all of whom participated in the governance of the 169. frank michelman, laws republic, 91 yale l. j. 1493 (1988); spirit of modern repubucanism, supra note 143, at 29. 170. frank d. balog, the scottish enlightenment and the liberal political tradition, in confronting the constitution, supra note 147, at 192; cass r. sunstein, beyond the republican revival, 91 yale l. j. 1539, 1548-49 (1988}. 171. sunstein, supra note 170, at 1548. 2006] my fa tiler. jolin locke and assisted suicide 89 state, were to act out of commitment to what was best for the society, keeping in check an exclusive concern with their self-interest.172 thus, the point of government was not merely the accommodation of pre-political preferences (e.g., to hold on to what i had before entering the social contract), but to work towards the "good."173 the philosophy favored true deliberation versus the pluralistic deals and trade-offs which so characterize modem american politics. 174 it sought the right social policy.175 that was pure civic virtue. on the other hand, the golden age of civic republicanism as it existed in the greek city-states176 and the italian city-states177 was not necessarily something one would consider ideal. those citizens participating in governance were an elite group which excluded women and minorities.178 also, commitment to the polis tended to translate into supporting a rigid party line in which individual deviation was not tolerated. 179 moreover, the notion of what constituted virtue evolved and changed over time. at times it referred to the duty of political participation.180 at others, it was not really political; but rather envisioned liberty as a means used to develop higher virtue, 181 as opposed to the employment of civic virtue to maintain liberty.182 in the hands of machiavelli, it was the art of amoral manipulation to keep the peace. for many of the founders, virtue encom­ passed qualities directly from the pages of ben franklin's poor richard's almanac: moderation and industry. this latter conception constituted a comfortable meld with locke. the commercial republic183 naturally 172. id. at 1544. 173. michelman, supra note 169, at 1503; mark seidenfeld, a civic republican justification for the bureaucratic state, 105 harv. l. rev. 1512, 1533-35 (1992). 174. sunstein, supra note 170, at 1549. 175. sunstein, supra note 170, at 1550. 176. pangle, the philosophical understandings of human nature informing the constitution, in confronting the constitution, supra note 143, at 14. 177. richard a. epstein, .modern republicanism-or the flight from substance, 97 yale l. j. 1633, 1634 (1988). 178. lindak.kerber,makingrepublicanism useful, 97yalel.j. 1663, 1667-70(1988); jonathan r. macey, the missing element in the republican revival, 97 yale l. j. 1673, 1675 ( 1988) (noting features of early american republic that smacked of elitism; e.g., state senate elected congressional representatives, electoral college, poll taxes and property qualifications, denial of vote to women); epstein, supra note 177, at 1635; derrick bell & preeta bansal, the republican revival and racial politics, 97 yalel. j. 1609, 1609 (1988). 179. pangle, the philosophical understandings of human nature informing the constitution, in confronting the constitution, supra note 143, at 14-15; michelman, supra note 18, at 1495. 180. pangle, the philosophical understandings of human nature informing the constitution, in confronting the constitution, supra note 143, at 56. 181. id. at 55, 56. 182. !d. at 64. 183. !d. at 69; w. r. newell, reflections on .marxism and american, in confronting the constitution, supra note 143, at 343. 90 indiana heal1h law review [vol. 3:43 accompanied locke's conception of the hoeral democracy, since commerce was to bring with it strength, contentment, and accordingly, less war.184 regardless of its historical reality, civic virtue, at least philosophically, provided a brake on the runaway individualism of a purely lockean view. for lockeans, society was only supposed to protect man's pre-political interests, and then let him go and prosper. the founders wanted more than that :from those chosen to be leaders.185 after all, the consent of the governed to be led by representative leaders was the basis for the government's legitimacy. the quality of leaders thus was central to the success of the enterprise. the founders wanted civic virtue186 and they considered the psychological nature of man, as well as the political and philosophical, 187 when forming their notion ofvirtue.188 particularly concerned about the motives of their leaders (e.g., virtuous commitment to the polis verses self-aggrandizement), 189 they attempted to encourage the fonner commitment by the electoral system and prevent the latter self-aggrandizement through the set of institutional checks which run throughout the constitution (e.g., the senate can impeach the president, the president can veto legislation, and such). the founders also did not see man as a totally self-contained lockean individual, functioning independently of other similarly situated lockean individuals. rather, man's obsession with his self-interest was tempered by the fact that he existed, not in isolation, but within private institutions such as churches, families, and work groups where qualities akin to civic virtue were developed and valued. 190 since the flowering of civic. republicanism took place in small city­ states such as athens and venice where all the eligible population could participate· in governance, such an arrangement was obviously not possible with a nation covering the entire eastern seaboard. in its place, the founders matched a representative democracy with a deliberative democracy where, under the first amendment, citizens could express their civic virtue by :freely . speaking, having access to infonnation, and being guaranteed the right to associate with others and to petition their government for grievances. consequently, civic republicanism provides modification to extreme reliance upon the social contract theory by adding an obligation in addition to producing and protecting. it requires political participation. voting, grumbling, or deliberately not voting are all variants on making one's civic 184. pangle. spiritofmodernrepubucanism,supra note 143, at96-97. iss. david f. epstein, political theory of the constitution, in confronting the constmmon, supra note 143, at 102. 186. ld at 93-98. 187./d. 188./d. 189. id. at 102. 190. james h. nickols, jr., pragniatism and the u.s. constitution, in confronting the constitution, supra note.143, at 380. for an extensive socio-antbropological analysis of the roleofinformalinstitutionsinpromotingcivicparticipation,seerobertd.putnam,bowling alone (2000). 2006] my father, john locke and assisted suicide 91 voice heard. thus, while everyone over the age of retirement has met the lockean obligations of production and protection, their duty within the underlying civic republicanism aspect of the constitution remains. they are not free to leave, whether by boat or lethal injection. but when they are also ill, and ill in a way such that it is not likely that they will ever again be able to participate politically-even with absentee ballots, e-mail and the like-continuing to maintain the obligation of civic participation is a hollow charade. now they can leave. my father was certainly one of those who had fulfilled his obligations under the social contract (he was seventy-nine), and would never again be capable of civic participation. d. can the line hold? but what about a forty-two-year-old who has exactly the same disease as my father had and is in exactly the same stage? does age alone disqualify her from claiming a right to kill herself under the social contract theory? then again, there are young people with such severe disabilities that they will never be involved in the military, commercial, or political life of the nation. why are they made to continue living? i could be accused of tailoring an argument to meet my father's case and no more. but that is not what i have done. rather, i have looked at the social contract as involving mutual obligations. that is a different issue than whether one is capable of fulfilling his or her obligations. a contract may obligate one to deliver certain goods to another from her factory. a tornado may destroy the factory so that it is impossible for her to fulfill the contract. that impossibility may well be a defense to a claim that one did not meet the obligation; but the fact that one may have this legal defense of impossibility does not mean that the obligation ceases to exist. if, suddenly; a good samaritan industrialist came forth and said, "hey, why don't you use my factory," one would be obligated to provide the promised goods. similarly, if a forty-two-year-old with pancreatic cancer suddenly went into remission, she would be obligated to be available for the nation's defense and security. if my father was miraculously healed, he would have no such obligation. he had already given the country what was owed under the social contract. that does not mean that my father then would be free to end his own life. having regained his health, he would now be capable of participating in the political community once again. as such, society could forbid his suicide. but it would not be the social contract which would oblige him to maintain his life. it would be the civic republicanism strain in our constitution's construction; for, again, he would have no further obligation under the social contract. one may, nonetheless, find this unfair to the forty-two-year-old, and a bit cold, as well. but all i am talking about is a constitutional· line where the government no longer possesses the power to interfere with the decision of 92 indiana health law review [vol. 3:43 someone in my father's circumstances to end his or her life. the legislature still can choose to give the same relief to the forty-two-year-old. e. arguments opposing a(y theory as with any such sweeping argument· as i have just proposed, accompanied by sweeping implications, there will be reasonable counter arguments. i will address each of those i can envision as honestly as i am able. 1. legitimacy of my source initially, one might question the legitimacy of deriving american constitutional rights from philosophy, and the philosophy of seventeenth century englishmen and ancient greeks. to me, these philosophies provide an entirely appropriate frame of interpretation. these are not philosophies which i just happen to find pleasing. they were consciously considered and specifically implemented when constructing our government and constitution. if anyone cares anymore about the framer's intent, here is the blueprint of our national edifice. resorting to these sources seems to me to be at least as legitimate as the types of inquiries into "deeply rooted traditions" and what is "implicit in ordered liberty,'' which are conducted under a substantive due process analysis.191 2. locke opposed suicide conceding the reliance of the founder's on locke and the social contract, readers of locke will point out one small problem with my reliance on his theory: in his work, john locke specifically said that we have no right to commit suicide. 192 in doing so, locke had both a theological and a conceptual ground. . the basis of this theological argument was a form of thomas aquinas' classic argument against suicide:193 our lives are not ours, but are god's 191. seejerrymashaw,aslfrepublican/nterpretation,91yau!.l.j.1685,1688(1988). (discussing the view that the norms and structure of the constitution, in addition to specific provisiods; provide appropriate grounds for intelpietation). 192. locke, supra note 17, at 19 (''though man in that state [of nature] have an uncontroulable [sic] liberty to dispose of his person or possessions, yet he has not liberty to destroy hiinself .. .''). 193. see barry, supra note 56, at 476 (1995); darrel w. amundsen, suicide and early christian values, in suicide and euthanasia-historical and contemporary 'ihemes 142, 190; 191-92 (baruch a. brady ed., 1989) [hereinafter historical and contemporary 1hemes); thomas l. beauchamp, suicide in the age of reason, in historical and contemporary 'dmmes supra; michael manning, euthanasia and physician-assisted suicide-klwngor carjng 17 (1958). williams, supra note 92, at 264. 2006] my father, .john locke and assisted suicide 93 property. 194 however convincing one may find this argument, a faith·based argument can have no purchase in a legal decision of otir pluralistic society. 19' locke's conceptual concern, on the other hand, comes out of the nature of the social contract as a mechanism to protect property.196 the protection of property, which the state insures in the bargain, includes the individual person as well as land and possessions.197 what locke wanted to prevent was affording any theoretical basis upon which it could be claimed that individuals had ceded to the state the right to arbitrarily kill them as part of the contract.198 certainty such rights had historically been claimed by absolute despots, and locke wanted no part in creating a philosophical system which could legitimate such appalling governance.199 so, if one's life ultimately belongs to god, and thus, is not one's own, one cannot give it to the state as part of the bargain for the social contract.200 again, it is a theological argument (an 194. see james f. childress, religious viewpoints, in regulating how we die, supra note 68, at 26 (discussing aquinas' "metaphors," i.~ .• gift, loan, and such); barry, supra note 56, at476; be1hspring&edlaron,eu1hanasia:spir.itual,medicalandlegallessons in terminal care 122 (1988). see also dworkin, supra note 33, at 195. 195. see samar, supra note 8, at 257-58 ("[i]t would be difficult to justify using religion as a basis for decisions in a plwalistic society that subscribes to a doctrine of separation of church and state."). a sense of this is reflected in the ~ority opinion in lawrence, 539 u.s. at570: it must be acknowledged, of course, that the court in bowers was making the broader point that for centuries there have been powerful voices to condemn homosexual conduct as immoral. the condemnation has been shaped by religious beliefs, conceptions of right and acceptable behavior, and respect for the traditional family. for many persons these are not trivial concerns but profound and deep convictions accepted as ethical and moral prin<:iples to which they aspire and which thus determine the course of their lives. these considerations do not answer the question before us, however. the issue is whether the majority may use the power of the state to enforce the8e views on the whole ilociety through operation of the criminal. law. "'ur obligation is to define the liberty of all, not to mandate our own moral code." citing planned parenthood of southeastern pa. v. casey, 505 u.s. 833, 850 (1992). 196. locke, supra note 17, at xvi-xix (providing introduction regarding locke's notion of property); 66 (''the greatest and chief end, therefore, of men uniting into common-wealths, and putting themselves under government is the preservation of their property."). 197. id. at 19 (''though the earth. and all inferior creations, be common to all men, yet every ·man has a property in his own person ..• j; 66 (''for the mutual preservation of their lives, liberties and estates, which i call by the general name, property.''). 198. locke, supra note 17, at 9 ("[y)et he has not the liberty to destroy himself ... j. 199. locke, supra note 17, at 89 ("[f]or man not having such an arbitrary power over his own life [i.e., to kill himself], can not give another man such power over it.j; 90 ("[ajbsolute domination, however inconsistent with it, as slavery is from property.j. 200. thirdly,despotical power is an absolute, arbitrarypoweroneman has over another, to iake away his life, whenever he pleases. this is a power, which neither nature gives, for it has made no such distinction ~ one man and another; nor compact can convey: forman not having such an arbitrary power over his own life, cannot give another man such a.power over it. locke, supra note 17, at 89 (emphasis added). 94 indiana heal 'ill law review [vol. 3:43 individual's life is god's), an argument which has no legitimate place in our legal arena, that locke employs to deal with this conceptual concern. yet, even if he had created some policy-based argument for why our lives are not our own, and, therefore, cannot be made part of the bargain, i do not know why locke thought this was necessary. why would i leave the state of nature and enter into this deal if granting the state this absolute and arbitrary power to kill me was part of the bargain? this would seem to make my life at least as uncertain as living in a condition of a state of war. i may, in fact, have a better chance preserving myself against other individuals in nature than against the organized power of the entire state bent on my destruction. even if my life is considered mine, it is hard to see any logic in making such a deal (unless that is the only offer on the table, and i judge it worth the risk calculating that it will never happen to me). in any event, this belief about suicide is hardly central to locke's theory of social contract which the founder's adopted. 3. civic republicanism was an aspiration, not an obligation which could limit the sweep of my position another attack on my theory would posit that my attempt to limit the sweep of my social contract argument by the insertion of civic republicanism fails. while the founders did consider aspects of civic republicanism, their principle concern was with having virtuous leaders. the size of the nation required a representational system, not the great gathering of citizens as in athens. surely they desired participation from the citizenry, and the first amendment and the electoral process created mechanisms to make that feasible. but these devices were more in the sense of giving people opportunities, not creating obligation. while the very idea of a (social) contract implies reciprocal obligations, civic :virtue extols an aspiration. if you are relying on civic republicanism as the basis for some obligation not to leave, it is just not there.201 i think this is a fair argument, but i do. not agree. the system depends on participation to function, and the more enlightened and numerous those ·who participate, the better. i believe one does have a civic obligation to participate, although because we are unable to tell whether or not failure to participate is a first amendment statement, we will not enforce that obligation. we can demand, however, that one at least be available to participate, not leave. 201. admittedly, it appears that civic republic:allism was far less signific:allt in the formationofourconstitutionthanloc:keantheory. seegardner,supranote 17,at 197-98,213; spirit of modern repubucanism, supra note 143, at 2-3 (presenting "a new interpretation of the moral, political, and religious teachings of locke's corpus" in which the "founder's moral vision" is revealed). 2006] my father, john locke and assisted suicide 95 4. there's virtue in just hanging on other arguments against my position· assume a more idealistic tone. even if one is no longer obligated to provide support and protection, willingness to suffer to the end gives an inspiring and heroic example to others. 202 i am not sure how inspiring or heroic all this is, but assuming so, that is the individual's choice. we do not require that heroism be a cultural norm. if it were the expected behavior, it would not be heroic. in the same vein is the argument that by shortcutting the dying process, one forfeits the opportunity for end of life enlightenment, lessons, reconcilia­ tion with others, and such.203 however, this does not seem like something we want (or even have any right) to impose as a social obligation on every individual. what is society's interest in this? it is ·difficult to imagine anything more private (unless one makes the hopelessly speculative argument that those left behind and not reconciled with will suffer as a result, and that suffering will take a form harmful to society). this position envisions one view of the good death. in a free society, in which citizens are imbued with first amendment protections, a government-imposed litany of the con-ectway to die is, to say the least, unsupportable. even if we were all to agree that this reflects a desirable way to employ the last chapter of our lives, individuals may be too sick and confused to participate, or may not have others available with whom to finish business. 5. weakening respect for life other counterarguments are of a more consequentialist nature. letting older people kill themselves will weaken respect for life, and this is something which society still has a legitimate interest in preventing. as such, one may still be held responsible to society under the social contract. 202. smith, supra note 26, at xix (using michael landon as an example); daniel callahan, reason, self-determination, and physician-assisted suicide, in the case against assisted suicide,supranote21,at67;jonie. tada, whbnisitrlohrtodie? 149(johnd. sloaned., 1992) (offering the example of choosing not to die is important). for some, suffering is morally important. see paul i. mishbin, euthanasia: the good of thb patibnt, the good of socibty 31 (1992) ("miguel de unamuno may not have been entirely wrong when he wrote: 'suffering is the substance of life and the root of personality. only suffering makes us persons.'"); michael manning, supra note 193, at 24; spring & laron, supra note 194, at 130; hyde, supra note 79, at 166; kevin d. o'rourke, o.p ., pain relief. ethical issues and catholic teachings, in birth, sufbring, and death 158 (kevin wm. wildes, fnncesc abel & john c. harvey eels., 1992). thus, some see suicide as cowardice. see barry, note 56, at 478-79; karen lebacqz & h. tristram engelhardt, jr., suicide, in euthanasia, supra note 55, at 682; karen redfibld jamison, night falls fast-understanding suicide 227 (1991) (stating this prevalent view in part accounts for why people could not believe that meriwether lewis killed himselt). see also garvey, supra note 9, at 15, 17 (stating the willingness to suffer requires courage). 203. john finnis, a philosophical case against euthanasia, in euthanasia examined, supra note 31, at 32. 96 . indiana health law review [vol. 3:43 this position suggests that the people like my father are to suffer again as figurative soldiers (a soldier who is being used solely as a means-and a symbolic one at that-to achieve some abstract societal end). the great nineteenth century utilitarian, john stuart mill, while considering the idea of a social contract ·to be a work of fiction, 204 did believe that citizens had reciprocal obligations with the state.205 however, it is hard to imagine that mill's utilitarian calculus would demand great suffering for tenuous social benefits. 206 also, it is difficult to comprehend how life would be perceived as less valued if someone in my father's situation killed himself. no one will confuse a decision by someone like my father to end his life with a similar decision by a heartbroken teenager, or a depressed forty-something. let me be clear. every day of an older and elderly person's life is as precious as a day in a younger life. an older life can be filled with as much joy, wisdom, generosity, and even passion as that of her juniors. yet at the same time, we feel that they have gotten their "fair innings."207 when she was ninety-two, my maternal grandmother told me that she had lived a good, full life, but now she could no longer see well enough to read or watch television, could not hear most of what was said around her, had difficulty moving about, and most ofher friends were dead. she did not long for death but was ready to welcome it when it came. she died of natural causes at age ninety-three. even if a very sick person in his late sixties chose to end his life, it is difficult to imagine anyone saying, ''this sixty-seven-year-old ended her life, so it just seems natural that teen suicide is acceptable." these two worlds simply do not connect; prohibiting the government from interfering with older and elderly people who are very ill will not create a pneumatic pressure weakening the value of life in our culture from age group to age group. furthermore, i cannot imagine that this will lead to massive or even dramatically increased suicides among even older and elderly persons. most older people want to live on and on. this is the dessert phase of life (if you have a minimum quantum of money and health). one is free like a child, but with the knowledge, resources, and autonomy of an adult only very, very 204. johnstuartmn.l, unlit arianism 55 (george shered., hackett publ'g inc. 1988) (1861) ("a favorite contrivance has been the fiction of a contract, whereby at some unknown period all members of society engaged to obey the laws, and consented to be punished for any disobedience to them ... "). 205. johnstuartmill,onliberty73(eiizabethr.apaported.,hackettpubl'glnc.l972) (1855) ("everyone who receives the protection of society owes a return for the benefit ... "). 206. cf. carl wellman, a moral right to physician-assisted suicide, 38 amer. philo. q. 271, 274-75 (2001) (''therefore. there are at least two much more limited moral liberties to commit suicide, when killing oneself is the only way to avoid violating a more stringent moral duty or when to refr¢n from doing so would demand excessive sacrifice" (emphasis added)). 207. callahan, supra note 52, at 181; somerville, supra note 53, at 17; cj. dworkin, supra note 33, at 88 (contending that at some point, one's "investment" in life has been substantially fulfilled). 2006] my father, john locke and assisted suicide 97 sick people wish this golden age of life to end. and even as to these persons, the vast majority will be able to achieve that desire by availing themselves of already accepted means-withdrawing life-sustaining treatment, poe, refusing lifesaving treatment, or terminal sedation. those to whom my social contract/civic republicanism theory really matter are very few. my father, however, was one of those few. e. putting theory to practice 1. governmental access to lethal drugs under the social contract/civic republicanism theory, the state could not prevent someone like my father from ending his life. one might ask, however, whether such a person has a legal right to have the government allow him access to lethal drugs. the government could say "go ahead, you're free to jump off a bridge, but we don't have to participate." as in the case of abortion, the government could take the position that it is not obligated to utilize tax dollars to support your choice.208 one might respond that tax dollars are not involved if the person seeking the drugs is willing to pay a reasonable price. after au, women can obtain a private abortion; they just cannot ask the government to pay for it. furthermore, we are not even talking about utilizing some government resource or facility. the drugs do not belong to the government, nor are they kept in a government warehouse. the government merely regulates their distribution. in the case of one entitled to suicide under the lockean contract, denying access to the most reasonable means available to a sick, older person to end their life would seem to constitute an unconstitutional burden as applied to such person. whatever the resolution of the legal issue, assuming the lockean-based right, the government should provide the drugs. otherwise, the alternative for many will be a violent death (e.g., gun, car, razor), an end which is a perversion of the very notion of thanatus. also, obtaining the pills is not the same as using them. for some, just knowing that they had an available out from suffering is sufficient. 209 they can relax, let go of the fear of suffering without end, and in fact never use the pills. 208. see harris v. mcrae, 448 u.s. 297, 316 (1980) (finding that "it simply does not follow that a woman's freedom of choice carriers with it a constitutional entitlement to the financial resources to avail herself of the full range of protected choices"). 209. william j. winslade, physician-assisted suicide: evolving policies, in physician­ assisted suicide, supra note 31, at 229 (describing how patients are comforted by knowing that they have the power to end their life if they wish, and never take the lethal pills).· cf. linda ganzini et al., physicians' experiences with the oregon death with dignity act, 342 new eng. j. med. 557,583 (2000) (reporting that physicians give lethal pills to one out of six patients who request, but only one out often of those patients actually take the pills). 98 indiana health law revmw [vol. 3:43 2. placing a third person into the equation assuming one agrees that the state cannot constitutionally interfere with the· decision of someone like my father to intentionally end his life, that does not mean that some third person automatically is entitled to enter into the equation. with the .entrance of this third person the suicide is no longer a private matter. 210 added now are the concerns that suicide is now made easier, the possibility of disguised homicide, the risk of coercion211 and, with the addition of the doctor, the risk of the feared slippery slope from voluntary assisted suicide to involuntary euthanasia. 212 how does this all play out under the lockean/civic republicanism analysis? there are two basic paths the analysis can take. one takes the position that, while the state may not interfere with the individual, it does not mean that the state has to make the act easier (or even possible) in any individual case. suicide still is not something that the state looks at as a positive good.213 if very sick, old people want to poison themselves that is their business. but the entrance of a third·party into the act is something quite different. that is the state's business, and it can choose to prohibit the involvement of third parties if it wishes. the other path focuses on the meaningfulness of the choice an individual like my father is now entitled to make under the philosophical commitment reflected in the lockean contract the relevant category, which people like 210. see callahan, supra note 52, at 110; see van zyl. supra note 28, at 103.; cf., margaret p. battin, is a physician ever obligated to help a patient die?, in reoui.atino how we die, supra note 68; tile etidcal, medical, and legal issues surroundinophysician­ assisted smcme 21 (linda l. emanuel ed., 1998) (noting that most sick people cannot kill themselves without help). 21 i. surrounding any discussion of assisted suicide is the concern that people will be coerced into choosing assisted suicide. see leon r. kass, i will give no deadly drug, in 1he case against assisted suicide, supra note 21, at 25-26. this is particularly a concern since the very ill tend to be vulnerable and dependant. id. 212. the concept of the slippery slope is often at the center of non-religious arguments in the euthanasia, assisted suicide debate. see robert i. misiibin, eljthanasja: 1he good of tile patient-1he good of society 17 (1992); gerald dworkin, r.g. frey, & sissela bok, supra note 98, at 44-45; thomas st. martin, euthanasia: the three-in-one issue, in euthanasia, supra note 55, at 600. 213. it has been contended that society, through law-legitimated control, attempts to maintain the illusion that it controls life and death. see patrick hanafin, surviving law: death community culture, 28 studies in law pol. & soc. 97 (2003): law attempts to govern life and death through the appropriation of images which give a fantasy of control over death. the functioning of the thanatopolitical state is underpinned by a perceived control over death and it representation. this means of controlling death is challenged when someone wishes to die in an untimely fashion. death may be timely when the state engages in the officially sanctioned killing of the death penalty but not when the individual assumes such a power to decide. when an individual goes before the law to obtain a right to die, instead of confronting death, legal institutions evade the issue and instead talk about life, and its sacred and inviolable nature. id. at 97. 2006] my father, john locke and assisted suicide 99 my father occupy, are those over retirement age who are so ill that they are likely never to be even minimally capable of participating in the political process. to categorically deny such people assistance, should they choose to end their lives, makes that choice illusory, since most in that condition simply could not kill themselves without assistance.214 i believe this second path is the correct one. admittedly, we are not dealing with a constitutional right in the traditional sense. my father's freedom from government interference was derived from the primary philosophies underlying the constitution, not any explicit textual provision or any unenumerated right wafting from the text. yet, i believe this freedom to be of the same pedigree as that of so-called fundamental rights, because at base, what makes all these rights fundamental is that they reside in that imaginative realm, comprising life, liberty, and the pursuit ofhappiness, which was never ceded to the state under the social contract. in a government of, by, and for the people, these are the aspects that define the contours of the individual. state regulation, which touches upon aspects of our lives which are so central to defining the boundaries between the realm of the state and the individual (whether derived from fundamental rights or lockean analysis), would seem to justify the same method of strict judicial scrutiny. such regulation is unconstitutional unless it satisfies a strict scrutiny-type showing of compelling and necessary. denying assistance to those over retirement age who are so ill that they likely will never be able to meaningfully participate in the political process is more than an undue burden;215 it is a de facto prohibition. whatever concerns the state retains when dealing with assisting the suicide of a person in my father's circumstances must be expressed through less burdensome means (e.g., regulation) than a total ban on assistance. 214. once we accept such a theory, administrative challenges inevitably will follow. what if my father got his pills, but gave them to someone else? there would be reasons not to do this. a computer could keep track so one could only get one set of pills. if one lost them, they are stolen, or such, one would have to go to court to get another set. but what if someone like my father took this risk and still got them for someone who was not entitled to them (e.g. 35 year old)? then i would hold my father (and anyone who knowingly aided him) subject to criminal charges. now one might say, "your father is dying; he's not going to care about some criminal prosecution which will never happen. he's too sick to even be taken out ofhis bed, let alone to court.'' you are correct. the detenence comes tiom the risk to anyone knowingly aiding my father. it would be extremely difficult (though not impossible) for my father to negotiate something like this without the aid of at least one other person who either knew what was going on, or acted in deliberate ignorance ("i don't want to know. don't tell me why i'm mailing these ... "). 215. for a discussion of the concept of undue burden within the context of fundamental constitutional rights see clark, supra note 27, at 79; casey, s05 u.s. at 874 (1992). cf. mill, on lmerty, supra note 205, at 97 (-.ting that if one has the right to do some act, they must be afforded the assistance to do it). · 100 indiana health law review [vol. 3:43 iv. conclusion basing a constitutional right on the two philosophies that formed the conceptual structure of our constitution comports with my own sense of why my father was entitled to die.216 at the same time, it offers a constitutional principle which can be cabined and controlled. under the lockean/civic republicanism theory, one does not face the problem of the inevitable breakdown in line drawing which would accompany adoption of the due process and equal protection theories. post-retirement age is a clear line. while all lines like this are somewhat arbitrary, this line at least corresponds to a cultural conception of when the society assumes one will retire from societal obligations. my father suffered, suffered terribly. he suffered long after we had talked over our lives together, and came to some closure. he suffered long 216. i should note for the reader's edification, that two other constitutional theories have been proposed to support a right to pas: the ninth amendment "natural rights" and first amendment religious freedom. for the reasons i discuss below, i do not find either theory sufficiently persuasive. natural rights and the constitution the locus of the self evident truths extoued in the declaration of independence that au men are endowed by their creator with "certain inalienable rights," is not precisely indicated in the constitution. for a time, they were thought to reside. in article iv section 2 of the u.s. constitution, the privileges and immunities clause. see corfield v. coryeu, 6 fed. cas. 546, 551-52 (cir. ct. c.e.d. pa. 1823); tlube, supra note 14, at 529. however, that possibility was laid to rest in the slaughter house cases. 83; u.s. 36 (1872). see also tribe. supra note 14, at 531 (stating 'that "[t]he natural rights theory of corfield had been abandoned by the mid1870's"). nearly one hundred years ~. these wialienable rights arguably resurfaced in justice goldberg's concurrence in griswold v. conn~cut, 381 u.s. 479, 486 (1965) in the guise of the ninth amendmeqt: the language and history of the ninth amendment reveal that the framers of the constitution believed that there are additional fundamental rights, protected from governmental infringement, which exist alongside those fundamental rights specifically mentioned in the first eight constitutional amendments. ld. at 488. see also hardaway, peterson, & mann, supra note 8, at 348-53 (positing that the right to assisted suicide could reside in the ninth amendment). it is difficult to perceive, however, what this adds to the due process, fundamental rights analysis already rejected by the glucksberg court. first amendment professor dworkin has argued that the ftee exercise of religion clause· in the first amendment acts as .a bar on a total ban of pas. dworkin, supra note 33, at 157, 164-65. there seem to be two problems with this position. first, there are those who oppose pas on totally non-religious grounds. seey ale kamisar, some non-religious views against proposed "mercy killinlf' legislation, in euthanasia. supra note 55, at 411; kamisar, reasons, supra note21;phillipberry,euthanasia-adialogue,26j.med.enucs370(2000)(positingdialogue between patient who desires euthanasia and an atheist physician who refuses). second, the court distinguishes religious belief (which is constitutionauy protected as an absolute) and religious activity (which can be regulated). see, e.g., employment division v. smith, 494 u.s. 872 (1990) (permiting application of drug laws to native american peyote ceremony); reynolds v. united states, 98 u.s. 145 (1878) (stating that even though polygamy is a part of mormon religious tradition, it may be prohibited under general law prohibiting polygamy). 2006] my father. john locke and) 101 after he had fulfilled all his worldly obligations, including making all provisions necessary for the care of my mother (who at the time had parkinson's disease); he suffered long beyond the bounds of courage. yet after glucksberg and vacco, most would say, that absent state legislation, the constitution will not permit someone in his place to stop the suffering. i cannot accept that our society can locate meaning in meaningless suffering. preemptive legislation in the european union and the united states on the topic of nanomedicine: examining the questions raised by smart medical technology emilee s. preble'" i. introduction ............................................................................... 398 ll. historical overview and the trouble with regulating new technologies ...................................................................... 399 a. nanotechnology and the development ofnanomedicine ........ 399 1. "what is nanotechltology? .................................................. 399 2. "what is nanomedicine? ..................................................... 400 b. factual sctmario of patient xtumor cured by nanites ...... 401 c. regulating the undiscoveredcontrolling the unknown ....... 402 lll. regulatory bacic.gr.oond ......................................................... 405 a. regulation in the united states ................................................ 405 1. the fda takes fhe i..ead ................................................... 405 2. the nanoteclmology task force ....................................... 407 3. special interest groups in the united states advocating for regulation ......................................................................... 409 4. opposition to nanotechnology research and development in the united states ............................................................ 412 b. regulation in the european union .......................................... 413 1. current regulatory scheme .............................................. 413 2. designated regulatory groups and agencies drafting policy ................................................................................. 415 3. considering regulation ..................................................... 416 4. focus of research and development ................................ 417 ill. analysis: strategy for governance over nanomedicine417 a. the trouble with regulating too early .................................. 41 t 1. in the united states ........................................................... 417 2. in the european union ...................................................... 419 b. fixing the focus on research and development ..................... 421 c. dealing with the ethical conundrum surrounding the unknown in nanomedicine ...................................................................... 422 1. contemporary comparison to a medical and ethical dilemma ............................................................................ 422 2. creation of a task force on ethical considerations ........ 424 • j. d., 2009, indiana university school of law-indianapolis; b.a., 2005, butler university. 398 indiana healtii law review [vol. 7:397 iv. conclusion .••••••••••..••••••••••••••...••••..•••••••••.•••••••••••••••.•••••••.•••.•••••••. 424 every industry that involves manufactured items will be impacted by nanotechnology research. everything can be made in some way better-stronger, lighter, cheaper, easier to recycle-if it's engineered and · manufactured at the nanometer scale.1 l introduction poised at the forefront of scientific and technological research and ad­ vancement, nanotechnology involves sophisticated, microscopic technolo­ gies that seek to manipulate matter on a molecular level. theoretically, these bits of nanotechnology (nanites) can be programmed, either through their molecular make-up, chemical composition, or through instructive cod­ ing, to perform many designed objectives. essentially, nanites can be pro­ grammed to do anything at all. although nanotechnology could be useful in virtually any industry, it has the potential to be extremely valuable in the medical field. nanites could be used to perform countless functions in health care, including the eradication of cancer-causing cells, restoration of eyesight, stimulation of the immtine system, and even destruction of tu­ mors. nanotechnology in the medical field, termed nanomedicine, is a topic with which many of the world's leading nations have already begun to wrestle. in 2004, the european commission ("ecj affirmatively decided to consider nanotechnology and nanomedicine as topics of the utmost im­ portance with the adoption of the communication2 entitled ''towards a eu­ ropean strategy for nanoteclniology.'.j the communication pushed the nanotechnology issue to the institutional level, facilitating the development of a comprehensive european strategy for dealing with the arrival of nano­ technology. 4 the formation of a specific subcommittee to research and plan for the arrival of nanotechnology demonstrates the considerable time and manpower the ec has invested in its efforts to anticipate the big arrival of 1. stan williams, director of quantum science research, hp labs, newbridge insti­ tutional research, http://www.newbridgereports.com/quotes.html (last visited nov. 1, 2008). 2. the european commission functions as the executiv" branch of the european union. ''the commission's job is to represent the common european interest to all the eu countries. to allow it to play its role as 'guardian of the treaties' and defender of the general interest, the commission also has the right of initiative in the lawmaking process." the european commission utilizes communications to disseminate policy, goals, and directives to the larger european community. the european commission at work, http://ec.europa.eu/ atwork.lblscfucts/index _ en.htm#comm (last visited jan. 18, 2009). 3. the european strategy for nanotechnology and the nanotechnology action plan, http://cordis.europa.eu/nanotechnology/actionplan.htm (last visited jan. 17, 2009). 4. /d. 2010] nanomedicine 399 science's smallest technologies. in the united states, regulatory agencies such as the food and drug administration ("fda") have already begun to formulate frameworks to address emerging issues presented by nanomedicine. since the beginning of the george w. bush administration, a great deal of emphasis has been placed on nanotechnology research and development. notably, the bush administration facilitated the creation of the national nanotechnology in­ itiative 5 which receives large amounts of federal funding each year, includ­ ing an estimated budget of$1.5 billion dollars in 2009.6 this note will take an in-depth look at existing regulatory frameworks concerning nanotechnology and nanomedicine in the united states ("u.s") and the european union ("eu''). it will consider the policy rationales that both nations have relied upon to justify use of their current regulatory sys­ tems dealing with nanotechnology and nanomedicine. this note will also consider any additional steps or measures that the us and the eu have tak­ en with regard to nanotechnology. this note seeks to evaluate how regula­ tory schemes can best maximize the benefits that nanotechnology and nanomedicine will give to society, while simultaneously anticipating and minimizing any negative effects such technology might have. most impor­ tantly, this note will attempt to determine if these regulations stifle the ad­ vancement and development of nanotechnologies. ii. historical overview and the trouble with regulating new technologies a. nanotechnology and the development of nanomedicine 1. what is nanotechnology? the prefix "nano" is a derivative of the term 'nanos' in greek, mean­ ing dwarf .. 7 "nano'' is also a prefix used in the metric system of measure­ ment to describe a specific unit of measure a nanometer is one billionth of a meter. 8 nanotechnology is technology that is created and functions on this extremely tiny, or dwarf, scale (the nanoscale). au example of the size of the nanoscale would be something "1/80,000th of the diameter of a hu­ man hair, or 10 times the diameter of a hydrogen atom."9 regardless of 5. brian wilhelmi, nanosilver: a test for nanotech regulation, 63 food & drug l.j. 89, 99 (2008) 6. ld. for a closer examination of the 2007-2009 funding break-down, see chart, infra part ii(a)(3). 7. m. lupton, nanotechnologysalvation or damnation for humans?, 26 med. & l., 349, 350 (2007). 8. /d. 9. /d. citing bbc news science/nature, www.bbc.com; "the smaller is better" in reason, www.keepmedia.com 400 indiana health law review (vol. 7:397 how specifically it is measured, nanotechnology is small, very small. nanotechnology d~velopment can be broken down into two distinct scientific• approaches: the top down approach and the bottom up approach.10 the top down approach involves the creation of a structure on the nanos­ cale.11 these creations would be machines of sorts that were produced by other machines or etching techniques.12 in contrast, the bottom up approach involves the construction of technology atom-by-atom or molecule-by­ molecule out of organic and inorganic matter.13 this approach, also re­ ferred to as molecular nanotechnology, is more firmly rooted in biology.14 not surprisingly, molecular nanotechnology is easily the most advanced form of nanotechnology.15 it not only involves the construction of engi­ neered organic matter on the small nanoscale, but also the ability to pro­ gram and sustain this organic matter to perform specific tasks over a period oftime.16 2. what is nanomedicine? the national institute for health (nih) defines nanomedicine as "an offshoot of nanotechnology, [that] refers to highly specific medical inter­ vention at the molecular scale for curing disease or repairing damaged tis­ sues, such as bone, muscle, or nerve."17 similarly, the european technology platform (etpi8 defines nanomedicine as technology that "ex­ ploits the improved and often novel physical, chemical and biological prop­ erties of materials at the nanometer scale. nanomedicine has the potential to enable early detection and prevention, and to essentially improve diagno­ sis, treatment and follow-up of diseases."19 unlike conventional medicine of today, "[n]anomedicine would facilitate the repair and improvement of the human body from the inside out, with a precision and delicacy far greater than the finest surgical instruments penint. • .2o · 10. lupton, supra note 7, at 350. 11. ld at 351. 12. this type of nanotechnology is best thought of as akin to microscopic robots or machines that were constructed out of raw materials and assembled by other machines. jd 13. lupton, supra note 7, at 351. 14. jd. 15. /d. 16. ld (providing an example through the creation of ''tiny living robots, called bio­ bots." /d.) 17. the nih common fund, nanomedicine, http://nihroadmap.nih.gov/nanomedicine/ (last visited nov. 8, 2008). 18. ''th~ members of the etp are stakeholder organisations in the field ofnanomedi­ cine including large industry, smes, industrial associations, research institutions, academia, hospitals and others." european technology platform, membership, http://www.etp­ nanomedicine.eu/public/about/membership (last visited mar. 14, 2009). 19. european technology platform, http://www.etp-nanomedicine.eu/public (last vi­ sited nov. 8, 2008). 20. lupton, supra note 7, at 351. 2010] nanomedicine 401 though these uses for nanomedicine have yet to reach beyond the theoretical in many respects, there are current advancements in this area of research. professor carlo montemagno, of the university of california, has created tiny robots that are, for all intents and purposes, alive?1 in describ­ ing his work, professor montemagno stated " ... the cells actually grow, multiply and assemble on their own. the device is alive.'.n · professor montemagno created these robots by growing rat cells onto silicon comput­ er chips?3 these robots, which are less than a millimeter long, can move themselves around without any external power source, and instead power themselves through the energy gained by contracting cells.24 when viewed under a microscope, professor montemagno's creations look like "tiny, two footed 'bio-bots."'25 the nanotechnologies he has created are a combina­ tion of both the top-down and bottom-up approaches?6 nanotechnology with the ability to power itself and perform various instructed tasks could be utilized in a variety of ways in the medical field. multiple nanites released into an individual could theoretically communi­ cate with each other to determine how to maneuver throughout the very complex human body.27 further, the nanites would theoretically be able to hone in on existing problems and predict where future problems might oc­ cur.28 collaboration between nanites would be an unprecedented, revolu­ tionary form of medical treatment. while performing all of these tasks the nanites would be able to communicate with one another to coordinate their efforts in the body;29 an example of this coordinated effort is explored in the next section. b. factual scenario of patient xtumor cured by nanites patient x is currently being treated for a cancerous tumor with cur­ rently known methods, such as chemotherapy and radiation. these treat­ ments are only moderately helpful in treating patient x's tumor, and have serious and undesirable side effects.30 patient x may ultimately win or lose 21. id. 22. id. 23. ld. 24. ld. 25. id 26. lupton. supra note 7, at 350. 27. "[i]n the young field of nanotechnology, scientists and engineers are taking control of atoms and molecules individually, manipulating them and putting them to use with an extraordinary degree of precision." adam keiper, the nanotechnology revolution, 2003 the new atlantis, 17, 17, available at bttp:/lwww.thenewatlantis.com/publicationslthe­ nanotecbnology-revolution. 28. id. at 24-5. 29. ld. at 25. 30. mayo clinic, cancer survivors: managing late effects of cancer treatment, http://www.mayoclinic.com/health/cancer-survivor/ca00073 oast visited jan. 18, 2009). 402 indiana health law review [vol. 7:397 her battle with cancer, but, regardless of the outcome, it is certain that pa­ tient x's battle will not be short. enduring·months;·even years, of harsh and. potentially damaging medical treatments will, undoubtedly take its toll on patientx. now suppose that patient x has the same type of cancerous tumor, on~ ly this time patient x lives in a world where nanomedicine exists.· once patient x's doctor becomes aware of the tumor, she is now able. to rely on a different form of treatment for patient x's cancer, nanomedicine. the treatment would be greatly different than chemotherapy and radiation. it would involve nanites, or microscopic robots that would be programmed to treat and cure the tumor. the .nanites would be instructed to attack and de­ stroy patient x's tumor. once the nanites are injected into patient x they begin to perform their programmed task; ·patient:x would be able to over­ come a battle with cancer quickly, and with much .tess suffering than pre­ vious known medical treatments. though the science has yet to specifically develop the type of technol­ ogy that would make this factual scenario ·possible, the .case of patient x is a hypothetically. plausible use of nanomedicine in· medical treatment. this note will continue to reference the above scenario to explore possible diffi­ culties, concerns, and benefits surrounding implementation and use of na­ nomedicine. c. regulating the undiscoveredcontrolling the unknown nanotechnology and nanomedicine is vexing to governments and reg­ ulatory agencies for precisely the same reason it elicits such excitement among innovators in the scientific and medical fields: the possibilities and potential risks of nanomedicine have yet to be imagined. this section high­ lights areas of concern with regard to nanotechnologies how the technolo­ gy is vulnerable and what risks those vulnerabilities introduce. cosmetic companies are concerned about the future of nanotechnolo­ gy in their industry because they believe it is possible for nanoparticle con­ taminants to find a way into their products and eventually make it into a person's blood stream through use of their cosmetics.31 potentially, the na­ noparticle contaminants will have detrimental effects?2 although the na­ noparticle contaminants considered here are not necessarily nanites, that is, 31. "[n]ew nanotechnologies are being widely deployed in cosmetics products, despite evidence of serious potential health risks ... [t]he physical application of some of the nano­ technologies to the body in cosmetics makes these uses uniquely prone to skin penetration, inhalation and ingestion of the nanotech materials." tim utile, sanford lewis & pamela lundquist, beneath the skin: hidden llabiuties, market risk and ·drivers of change in the cosmetics and person care products industry 2·(2007), available at http://iebn.org/filesaltiiehncosmeticsreportfin.pdf [hereinafter beneath the skin]. 32. see id; see also nanowerk, new report slams naiwtechnology z'n cosmetics, http://www.nanowerk.com/newslnewsid=l505.php (last visited nov. 2, 2008). 2010] nanomedicine 403 they may not be programmed with a specific purpose, it does demonstrate · the fear that surrounds the unknown effects that these tiny particles could have on human physiology.33 imagine, a woman gets up in the morning and applies her make-up as usual and subsequently becomes violently ill due to a nanoparticle contaminant.34 there are currently no ways of detect­ ing these contaminants. as a result, physicians will face difficulty in treat­ ing the woman because they will not be able to determine the source of the patient's illness.35 additionally, even if the source of her illness can be as­ certained for treatment purposes, the challenge of determining who should be liable for her illness remains. though the nanoparticle contaminants are not directly related to nanomedicine, this situation demonstrates the poten­ tial risks matter created on the nano-level present to the medical field. another very real fear surrounding nanomedicine addressed the poten­ tial affects on human toxicology. "the lack of knowledge about how nano­ particles might affect or interfere with the biochemical pathways and processes of the humali body'' remains unknown. 36 it is possible that na­ nomedicine could be extremely harmful to human physiology. the euro­ pean technology platform on nanomedicine notes some fears in its vision report: "the risks and challenges ofnanomedicine comprise issues of tox­ icity and carcinogenicity, as well as long-term stability and excretion path­ ways for artificial nanostructures, and technological challenges in molecular manufacturing, quality assurance and eventually, the programmability of nanodevices. "37 one report aptly articulated that the danger of nanotech­ nology is precisely in the fact that we do not know what the dangers are ... they remain unknown.38 it is difficult to anticipate the effects, harms, 33. see wilhelmi, supra note 5, at 97 (discussing the drastically different effects that nanoparticles with even the smallest degree of compositional variance from their larger­ molecule counterparts can have on surrounding material). 34. beneath the skin, supranote31, at2. [m]any potentially harmful chemic• have been found to make their way into cosmetics and personal care products. the threats to health may include ... cancer, harm to developing fetuses and infants exposed to the chemicals through baby products or their mother's cosmetics use, and disruptions of various organ or hormonal systems in the body. i d. 35. id. 36. nanowerk, the potential and the pitfalls of nanomedicine (may 7, 2007), http://www.nanowerk.com/spodightlspotid=l891.php (last visited september 22, 2009) [he­ reinafter potential pitfalls]. 37. european technology platform on nanomedicine, v'jsion paper and basis for a strategic research agenda for nanomedicine, 12 (sept. 2005) available at ftp://ftp.cordis.europa.eulpublnanotechnology/docs/nanomedicine_visionpaper.pdf. 38. rick weiss, nanotechnology risks unknown, 'die washington post, sept. 26, 2006, available at http://www. washingtonpost.com/wp-dyn/content/article/2006/09/25/ ar200609250ll38.html (noting that "[a]bout 300 consumer products already contain na­ noscale ingredients ... , including several foods and many cosmetics, with little or no research to document their safety"). 404 indiana health law review [vol. 7:397 and benefits of a product so new in its conception when even those who are most familiar with it can do little more than theorize as to its outcomes and application. perhaps these reasons account for the fact that many current discus­ sions on nanotechnology are steeped in complex ethical issues. 39 topping this list of ethical concerns is the way in which nanotechnology will likely be able to pennit human enhancement. the potential use of nanotechnolo­ gy for human enhancement blurs the lines between medical and non­ medical uses of the technology.40 nanomedicine could not only cure pa­ tient x's cancer, it could make her stronger, more energetic, or improve other physiological characteristics in·ways that stretch far beyond the origi­ nal goal of eradicating her cancer. what would further complicate the issue is if patient x purchased the nanites used to cure her cancer. she would then own them and could theoretically have them reprogrammed to perform any function she desired. suddenly, the absence of an ethical line in the sand becomes quite noticeable. the question of whether patient x should be able to do with her nanites what she chooses becomes important to an­ swer. some theoretical applications for nanomedicine are extremely attrac­ tive. consider robert a. freitas '41 proposed use of artificial red blood cells.42 his fabricated cells are theorized to "be capable of delivering oxy­ gen [to the human body] many hundreds of times more efficiently than hu­ man red blood cells.'"'3 respiratory diseases would likely be eradicated with this technology.44 transfusions from real blood donors would be un­ necessary.45 athletes could increase their endurance; scuba divers could hold their breath underwater for hours at a time.46 this would all be possi­ ble because of nanomedicine. these possible uses of nanomedicine raise ethical concerns in the form of human enhancement, which will be discussed later in this note. nevertheless, nanotechnology and nanomedicine still remain a hopeful promise of numerous benefits slated for the future horizon in terms of med­ ical treatment. regulators and legislators must remain ever cognizant of the ethical concerns surrounding nanomedicine. they will certainly be tasked 39. potential pitfalls, supra note 36. 40. ld. 41. "robert a. freitas jr .... authored the first detailed technical design study of a med­ ical nanorobot ever published in a peer.reviewed mainstream biomedical journal. •. [and] is the author ofnanomedicine, the first book-length technical discussion of the potential medi­ cal applications of molecular nanotechnology and medical nanorobotics." institute for mo­ lecular manufacturing, robert a. frietas jr., senior research fellow, http://www.imm.oqy' about/freitas/ (last visited mar. 12, 2009). 42. keiper, supra note 27, at 25. · 43. id. 44. !d. 45. /d. 46. ld. 2010] nanomedicine 405 with the delicate and difficult choices that determine who we are and what we ought to be able to permit ourselves to become. at this moment, "[a]s the science of [nanotechnology] leaps ahead, the ethics lag[] behind. "47 iii. regulatory background· a. regulation in the united states on december 3, 2003, president george w. bush signed the nanote­ chology research and development act (nrda).48 the nrda authorized funding for nanotechnology research for a period of four years beginning in fiscal year 2005.49 this funding was spread across ten federal agencies and totaled approximately $849 million.50 nanotechnology research and devel­ opment "has been a priority for the administration for the last three years."51 in fiscal year 2009, federal funding for this initiative totaled $1.5 billion dollars. 52 in addition to this program, other federal agencies have stepped up to tackle the topic of nanotechnology regulations. 1. the fda takes the lead the fda is a federal agency within the united states department of health and human services.53 it is charged with the safety regulation of food, drugs, medical devices, etc. used and consumed by the american po­ pulace. 54 historically, the fda has been successful in regulating new tech­ nologies especially in the field of biotechnology. 55 the fda is extremely important to the development of nanotechnology and nanomedicine, be­ cause most new products that would employ this technology would require 47. anisa mnyusiwalla, abdallah s. daar & peter a. singer, 'mind the gap': science and ethics in nanotechnology, 14 nanotechnology r9, r9 (2003), available at http:/ /www.iop.org/ej/article/0957 -4484114/3/20 llt303rl.pdf. 48. the white house, http://www.whitehouse.gov/news/releases/2003/l2/200312037.html (last visited nov. 2, 2008). 49. ld. 50. id. 51. the white house, http://www.whitehouse.gov/news/releases/2003/12/200312037.htrnl (last visited nov. 2, 2008) (noting that the funding for nanotechnology research and development has gone up 83% since 2001). 52. national nanotechnology initiative (nni), funding, http://www.nano.gov/html/ about/fimding.html (last visited jan. 16, 2009). 53. u.s. food & drug administration, about fda: centers & offices, http:// www.fda.gov/aboutfda/centersoffices/default.htm (last visited sept. 24, 2009) [hereinafter "about fda"]. 54. id. 55. john miller, student note, beyond biotechnology: fda regulation ofnanomedi­ cine, 4 colum. sci. & tech. l. rev. l, 2 (2003) (discussing the fda's past success with regulations on biotechnology, but noting that nanomedicine will present a new challenge in regulation). 406 indiana health law review [vol. 7:397 fda approval before public consumption and use. 56 the fda is involved in the field of nanotechnology in a variety of ways. 57 through the use of both internal and external working groups, the fda remains educated and aware of the progress of the nanotech indus­ try.58 though a regulatory agency, the fda remains engaged in areas of research surrounding nanotechnology. this research is not developmental in nature, but rather, is used to determine the characteristics of nanotech­ nology and focuses on understanding how nanotechnology interacts with other fda-approved products. 59 the fda has also tentatively responded to the question surrounding jurisdiction over nanotechnology products.60 categorization options under the fda are drugs, devices, biologics, or some combination thereof.61 cur­ rently, the belief is that nanotechnologies will be products comprised of a combination of the above three.62 troublesome for the fda is that many of their different centers across the country regulate combination products dif­ ferently. 63 predictability and consistency in regulation are only a few of the concerns posed by this managerial nightmare. 64 since the fda stipulates the requirements and guidelines for the ma­ jority of products in the u.s., it follows that the fda is the most suited at this time to tackle nanotechnology regulation.65 the fda responded to a question about the risks of nanotechnology and whether or not these tech­ nologies should be regulated differently: existing requirements may be adequate for most na­ notechnology products that we will regulate. these products are in the same size-range as the cells and molecules with which fda reviewers and scientists associate every day. in particular, every degradable medical device or injectable pharmaceutical generates particulates that pass through this size range during the processes of their absorption and elimination by 56. jessica k fender, student note, the fda and nano: big problems with tiny technology, 83 cm.-kent l. re:v. 1063, 1065-66 (2008). 51. nakissa sadrieh & parvaneh espandiari, nanotechnology and the fda: what are the scientific and regulatory considerations for products containing nanomteria/s?, 3 nanotechnology l. & bus. 339, 341-45 (2006) . . 58. !d. at 341-42. 59. id at 342. 60. u.s. food & drug administration, science & research: frequently asked ques­ tions, http://www.fdagov/scienceresearchlspecialtopics/nanotechnology/frequentlyask:edquestions/ default.htm (last visited nov. 1, 2008) [hereinafter fda nanotechnology f aq]. 61. sadrieh & espandiari, supra note 57, at 342. 62. id at 343. 63. !d. 64. id 65. id. at 344. 2010] nanomedicine the body. to date, fda has no knowledge of reports of adverse reactions related to the "nano" size ·of re­ sorbable drug or medical device products. if new risks are identified, arising from new materials or manufac. turing techniques· for example, new tests or other re­ quirements may be needed.66 2. the nanotechnology task force 407 in 2006, the fda formed the nanotechnology task force (ntf),67 a body specifically dedicated to "determining regulatory approaches that en­ courage the continued development of innovative, safe, and effective fda­ regulated products that use nanotechnology materials."68 the ntf is com­ prised of members from each of the fda centers.69 during a public meet­ ing, ntf co-chair dr. randall lutter said that the ntf would be also creating "guidance documents" for nanote.chnology practitioners' use to facilitate a better understanding how the fda will likely interpret and apply existing laws and regulations to the developing technology.70 the ntf has arguably adopted a "wait and see" approach to nano­ technology regulation. in its 2007 report, the ntf focused on the major issues: 1) examining the state of current knowledge regarding nanotechnol­ ogy; 2) "the fda's ability to address scientific issues" in products contain­ ing nanotechnology; and 3) "describing the regulatory authorities as they relate to nanotechnology in fda regulated products.'m the fda is inten­ tionally avoiding a narrow definition for nanotechnology at this point and does not propose any specific mandates or regulations beyond those cur­ rently in place to guide existing technology.72 to not completely frustrate those hoping for some direction in terms of future nanotech regulation, the ntf report offered limited guidance by encouraging a reliance on research and the "predicative value of scientific studies."73 this is arguably insuffi­ cient guidance at all. 66. fda nanotechnology f aq, supra note 60. 67. wilhelmi, supra note 5, at 100. 68. u.s. food & drug administration, fda nanotechnology task force, http:// www.fda.gov/scienceresearchlspecialtopics/nanotechnology/nanotechnologytaskforceldefault.htm (last visited jan. 16, 2009). 69. fda centers include: l) center for biologics evaluation and research; 2) center for devices and radiological health; 3) center for drug evaluation and research; 4) center for food safety and applied nutrition; 5) center for veterinary medicine; 6) national cen­ ter for toxicological research; 7) office of chief counsel; 8) office ofthe commissioner; 9) office of regulatory affairs. about fda, supra note 53; see wilhelmi, supra note 5, at 100. 70. wilhelmi, supra note 5, at 100. 71. !d. at 100-01. 72. !d. at 101. 73. /d. 408 indiana health law review [vol. 7:397 the ntf report also contained an express lack of confidence in cur­ rent safety testing methods for products used and approved by the fda as applied to nanotechnology. 74 current research that has shed light on electr­ ically neutral silver nanoparticles is illustrative of this point.75 previously, it was believed that nanoparticles would behave essentially the same as their larger, molecular sized counterparts.76 electrically neutral silver na­ noparticles have been found, however, to cross plasma membranes with greater ease than their charged counterparts.77 this unexpected behavior demonstrates that traditional scientific assumption may not adequately pre­ dict how even a simple change in particle size or structure could alter exist­ ing chemical, biological, or physiological structures.78 because of the immense uncertainty, the ntf report repeatedly em­ phasizes the need for collaborative efforts to pool knowledge and resources to lessen the unpredictability ofnanotechnology.79 the ntf's emphasis on making analyses on "a case-by-case basis" in the summary "recommenda­ tions for considerations" sections of the report that were to specifically ad­ dress how nanotechnology would or would not fit into the current regulatory scheme is indicative of this position. 80 this "case-by-case" lan­ guage neatly identifies the fda's current approach for regulating nano­ technology in its various products as one of "wait and see." specific direction as to which fda regulations would apply to nano­ technology and nanomedicine would be applicable was not given thorough consideration in the ntf report. rather, the report focused on the many product types in which nanotechnology will be applicable.81 it is likely that this hesitance to focus nanotechnology into one category was also a func­ tion of the "wait and see" approach the ntf has taken towards the develop­ ing technology. still, however, there are certain categories within the fda that do po­ tentially seem appropriate for nanomedicine as it is anticipated to develop. one notable category with a strong relation to nanomedicine is the device regulation category. though the use of nanotechnology in pharmaceuticals 74. /d. at 102. 75. /d. 76. wilhelmi, supra note 5, at 102. 77. /d. (citing chun-nm lok et al., silver nanoparticles: partial oxidation and antibacterial activities, 12 j. of biological inorganic chem. 527 (2007)). 78. wilhelmi, supra note 5, at 102. 79. /d. at 103. 80. u.s. food and drug administration, nanotechnology: a report of the u.s. food and drug aomjnistra tion nanotechnology task force 35 (2007), available at http://www.fdagov/nanotechnology/taskforcelreport2007 .pdf [hereinafter ntf report]. 81. the list included new drugs and biological devices, over the counter monograph drugs, animal drugs and new feed containing animal drugs, devices, food additives and gras (generally recognized as safe) food ingredients, color additives, cosmetics, dietary supplements, and labeling and advertising claims for conventional foods and dietary supple­ ments. /d. at 19-20. 2010] nanomedicine 409 is also extremely. relevant to nanomedicine, it remains to be seen whether this technology will be governed by a separate section outside that of medi­ cal devices. currently, devices regulated under the fda fall into three catego­ ries. 82 class i devices are considered low risk and subject to very few con­ trols (labeling, adverse event reporting, etc.). 83 class ll devices have a higher risk to the public and contain more complex technology.84 devices under this category must follow specific pre-market review protocols wherein a manufacturer must "demonstrate that [its] new device is 'substan­ tially equivalent' with regard to safety and effectiveness to a similar device already legally marketed in the united states:.ss class ill devices are com­ prised of the most complex and risky devices available.86 these devices are subject to pre-market approval through extensive clinical testing and peri­ odic reporting on new developments. 87 alterations to any class ill device require further documentation and testing. 88 class ill devices are those that pose a "significant risk" to the public. 89 if forced into an existing category as the fda and ntf have sug­ gested is appropriate, nanomedicine technology will likely fall into the class ill designation unless another class division is added to specifically address nanotechnology. the latter option may prove the most appropriate considering the delicate and unpredictable nature of nanotechnology.90 at this point, the ''wait and see" approach still applies. 3. special interest groups in the united states advocating for regulation in addition to the efforts spearheaded by the fda, there are other agencies currently operating in the u.s. that focus on nanotechnology. one such organization is the national nanotechnology initiative (nni), which was established in 2001 to coordinate research and development efforts on nanotechnology at the federallevel.91 the goals ofnni are to "[a]dvance a 82. id at24. 83. !d. 84. !d. 85. !d. 86. !d. 87. ntfreport,supranote 80, at24-5. 88. !d. at 25. 89. "significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants." !d. 90. see wilhelmi, supra note 5, at 102 (discussing how the smallest change in the molecular structure of nanoparticles drastically affects the way nanoparticles behave and interact with surrounding matter). 91. national nanotechnology initiative (nni), http://www.nano.gov/htmvaboutlhome_ about.html (last visited nov. 2, 2008). 410 indiana health law review [vol. 7:397 world-class nanotechnology research and development program[;] [f]oster the transfer of new technologies into products for commercial and public .benefit[;] [ d]evelop and sustain educational resources, a skilled workforce, and the supporting infrastructure and tools to advance technology[; and] [s]upport responsible development ofnanotechnology."92 further, the nni is committed to the expansion of "scientific understanding of the nano­ meter scale phenomena."93 nni is governed and coordinated by the nanoscale science, engineer­ ing and technology (nset) subcommittee, a group led by a managing board and representatives from over 25 of the nation's federal agencies.94 nset is a subcommittee of the larger national science and technology council committee on technology.95 nset uses one of its fom working groups to specifically focus on health and environmental concerns sur­ rounding nanotechnology and nanomedicine.96 nni is funded by the federal government. it hasan estimated budget of$1.5 billion for the 2009 fiscal year.97 nni invests these federal funds in federal agencies with programs and projects specifically related to nano­ technology research and development. 98 the following chart details the distribution ofnni funds to federal agencies. 92. /d. 93. /d. 94. national nanotechnology initiative, bttp:/lwww.nano.gov/btmji aboutlnnipartic (last visited jan. 16, 2009). 95. /d. 96. nanoscale science, engineering and technology (nset) subcommittee working groups, http://www.nano.gov/h1m1/about/nsetworkinggroups.html (last visited jan. 16, 2009); 97. national nanotechnology initiative fy 2009 budget highlights, http://www.nano.gov/nni _ fy09 _budget_ summary. pdf {last visited april 21, 201 0); see also national science and technology council, the national nanotechnowgy initiative: s1rategic plan (2007), awjilable at http://www.nano.gov/nni_strategic_ plan_2007.pdf. · 98. national nanotechnology initiative, http://www.nano.gov/h1m1/about/funding.html (last visited jan. 16, 2009). 2010] nanomedicine nni budget 100'7-:z~ services (national institutes of health department of commerce (national institute of standards total 411 each of the above organizations has some budget/investment opera­ tions set aside for nanotechnology research and development.100 to qualify for funding an organization must have a budget/investment included under eight categories outlined in the nni strategic plan.101 in addition to nni, there are other, lesser known organizations operat99. national science & technology council, national nanotechnology initiative: fy 2009 budget & highlights 1, available at ht1p:/lwww.nano.gov/nni_fy09_budget _summary.pdf(last visited february 14, 2010). 100. funding, http://www.nano.gov/html/about/funding.html (last visited jan.. 16, 2009). i 01. the eight program component areas include: 1) fundamental nanoscale phenomena and process; 2) nanomaterials; 3) nanoscale devices and systems; 4) instrumentation re­ search, meteorology and standards for nanotechnology; 5) nanomanufacturing; 6) major research facilities and instrumentation acquisition; 7) environmental health and safety; 8) and educational and societal dimensions. funding strategy: nn1 program component areas, http://www.nano.gov/html/aboutlfundingstrategy.html (last visited jan. 16, 2009). 412 indiana health law review [vol. 7:397 ing in the united states that address nanotechnology. the international association of nanotechnology (ian) is a non-profit international organi­ zation based in california that focuses on promotion of scientific and busi­ ness development in nanotechnology?02 in contrast to ian's goals for nanotechnology advancement, the center for responsible nanotechnology (crn) states that their purpose is ''not to predict, but to prepare; not to de­ termine exactly when and how nanotechnology will enable disruptive mole­ cular manufacturing, but to stimulate effective preparation for it, whenever and however it comes. "103 unlike other previously discussed agencies, crn is deeply concerned about the risks associated with nanotechnolo­ gy. 104 crn attempts, however, to balance these risks against the backdrop of "cautious optimism. "105 4. opposition to nanotechnology research and development in the united states though nanotechnology and nanomedicine have many supporters there are other groups in the united states that are opposed to nanotechnol­ ogy research and development.106 at the forefront of opposition to nano­ technology is the etc group action group on erosion, technology and concentration (name to be pronounced "et cetera").107 the "etc group is dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights. "108 deeply concerned about the neg­ ative impacts and effects of nanotechnology, the etc group is calling for an evaluation of the "social implications of all nanotechnologies," and ar­ gues that "in the meantime •.. a moratorium should be placed on research involving molecular self-assembly and self-replication."109 the etc group's skepticism about nanotechnology is motivated by a 102. international association of nanotechnology, http://www.ianano.org (last visited nov. 2, 2008). 103. center for responsible nanotechnology (crn), http://\vww.cmano.org/index.html (last visited nov. 2, 2008). 104. id 105. crn, "issues, positions and urgency in nanotechnology policy," http:/lwww.crnano.org/positions.htm (last visit april21, 2010). 106. ''[t]he prominence of anti-nanotechnology activists .. .in high-level policy debates around the application of nano-engineering to the fight against global warming arguably slowed the federal government's willingness to underwrite such research." nanowerk, nano tomorrowsscenario 4 "presidential commission on molecular manufacturing analysis: origins of the present crisis," available at http://www.nanowerlc.comlnanotechnologylnano _tomorrows_scenario4.html (last visited nov. 2, 2008). 107. etc group, about etc group, http://www.etcgroup.orglenlabout/ (last visited nov. 2, 2008) [hereinafter about etc]. · 108. id 109. etc group, nanotechnology, http:llwww.etcgroup.org/enf~logy.html (last visited jan. 16, 2009). 2010] nanomedicine 413 desire to protect underserved and underrepresented members of society. 110 specifically, they posit that nanomedicine and the large amounts of money poured into its research and development primarily benefits the wealthy. 111 if nanomedicine is pursued too zealously, the etc group argues, it could divert important funding away from programs that benefit the underserved and reduce essential health services already suffering from a scarcity of re­ sources.112 b. regulation in the european union on may 12, 2004 the european union (eu), through the ec, issued an action entitled "towards a european strategy for nanotechnology."113 this action was created to tackle specific issues in regards to nanotechnolo­ gy: offer guidelines for future policy, achieve consumer confidence in nano­ technology products, avoid health risks, create conditions for responsible development of the technology, and above all, attain these goals with the law already in existence.l14 the use of "law all ready in existence" seems strikingly similar to the fdaintf "wait and see" approach to nanotechnol­ ogy regulation. 1. current regulatory scheme the eu uses legislative tools called "directives" to obtain overarching goals within each member state.115 directives are not explicative of the means by which these goals should be obtained, but rather focus on the out­ comes and goal of a directive.116 as a result, member states implement legislation at the national level to achieve directive goals over a period of time, usually with an articulated final deadline.117 directives are not uni­ form to the entire eu, and can apply to all or only some member states.118 "directives are used to bring different national laws into line with each oth110. about etc, supra note 107. 111. etc group, nanotech rx medical applications of nand-scale technologies: what impact on marginalized communides?, 33 (2006) available at http://www.etcgroup.orglupload/publication!593/01/etc06nanotechrx.pdf. 112. /d. at 31-35. 113. giorgia guerra, european regulatory issues in nanomedicine, 2 nanoethics 87, 87 (2008); see also european commission, the european strategy for nanotechnology and the nanotechnology action plan, http://cordis.europa.eu/nanotechnology/actionplan.htm (last visited jan. 17, 2009). 114. guerra, supra note 113, at 87. (emphasis added). 115. european commission, how eu law is appliednational implementation ofeu directives, http:l/ec.europa.eulcommunity _law/directives/directives_ en.htm (last visited jan. 1"7, 2009) (explaining the function and purpose of eu directives). 116. !d. 117. /d. 118. /d. 414 indiana health law review [vol. 7:397 er, and are particularly common in matters that affect the operation of the single market (e.g. product safety standards)."119 "nanobiotechnological'' compositions (as they are called in the eu) generally are considered to fall under three preexisting directive frame­ works.120 the first is directive 90/385/eec which relates to active implan­ table medical devices.121 a product falls under this directive if it is a "medical device" and both "active" and "implantable".122 the applicability of this regulation is particularly interesting because nanomedicine technol­ ogies will be implanted into the human body in some circumstances. ''im­ planted" means "totally or partly introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure." 123 some types of nanomedicine could potentially fall under this "im­ plant" category, but ultimately that will depend on how nanomedicine de­ velops. as in the patient x scenario described earlier, for example, some types of nanomedicine now being researched involve the introduction of microscopic nanites into the body to perform a specific task (as in patient x's case, to remove a tumor). once that task has been completed, the na­ nites would have performed the task for which they were programmed and would at this point shut down and leave the body. thus, the question be­ comes whether the nanites would qualify as sufficiently "intended to remain after the procedure" to fit within the "implant" category. 124 further, it is possible that certain nanotechnologies will be developed that are intended or able to remain in the body indefinitely after they are inserted.125 the second directive framework that nanotechnology falls under is di­ rective 93/42/eec -medical devices.126 this medical device directive has the most general applicability to nanotechnology.127 "medical device" is defined as "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software in­ tended by its manufacturer to be used specifically for diagnostic and/or the119. id 120. giorgia guerra, a model for regulation of medical nanobiotechnology: the eu­ ropean status quo, 3 nanotechnology l. & bus. 84, 87-88 (2006) [hereinafter guerra, a model]. 121. /d.at 87. 122. council directive 90/385, the approximation of the laws of the member states relating to active implantable medical devices, art. l, 1990 o.j. (l 189) 1,3 (en), availa­ ble at http://eur-lex.europaeu!lexuriserv!lexuriserv.do?uri=consleg: 1990l0385:20071 011: en:pdf (last visited feb. 24, 201 0). 123. id. 124. !d. 125. see keiper, supra note 27, at 20-1 (discussing theories of nanotechnology applica­ tion by scientist, kim eric drexler, who posits that nanotechnology will eventually be used in ways that would alter human appearance on a permanent basis if desired). 126. guerra, supra note 113, at 88. 127. id 2010] nanomedicine 415 rapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. " 128 the purpose of the medical device directive is· defined, in pertinent part, as the " ... alleviation of dis­ ease," " ... alleviation of or compensation for an injury or handicap," and " ... modification of the anatomy or of a physiological process."129 most nanomedicine applications would fall squarely within the guidelines of di­ rective 93/42/eec. the third regulation applicable to nanomedicine is directive 98/79ec in vitro diagnostic medical devices. 130 an in vitro diagnostic medical de­ vice includes those which are: a reagent, reagent product, calibrator, control materi­ al, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, . including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information.131 in vitro is a technique in which procedures are performed on living matter outside the controlled environment of the living organism (or, in lay terms, in a test tube).132 as discussed in further depth below, nanomedicine is ex­ pected to have many applications for in vitro research and treatment. 133 the eu is currently considering nanotechnology and its applications under these directives.u4 . 2. designated regulatory groups and agencies drafting policy the european technology platform on nanomedicine (etp) is spear­ heading the nanotechnology movement in europe.135 the etp website de128. council directive 93/42, concerning medical devices, art. 1,1993 o.j. (l 169) 1, 5 (en), available at http://eur-lex.europaeu!lexuriserv/lexuriserv.do?uri=consleg:l993l 0042:20071011 :en:pdf (last visited nov. 8, 2008). 129. id. 130. guerra, supra note 113, at 87-88. 131. directive 98/79, in vitro diagnostic medical devices, art. 1, 1998 o.j. (l 331) 1, 7 (en), available at http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=consleg:1998l 0079:20031120:en:pdf (last visited nov. 8, 2008). 132. id 133. european technology platform on nanomedicine, vision paper and basis for a strategic research agenda for nanomedicine, 15 (sept. 2005) available at http://www.etp­ nanomedicine.eu/public/about/press-documentslpublicationsletp-nanomedicine-visionpaper [hereinafter etpstrategic research agenda]. 134. guerra, supra note 113, at. 87-88. 135. the europeantechnology platforms "[p]rovide a framework for stakeholders, led by industry, to define research and development priorities, timeframes and action plans on a number of strategically important issues where achieving europe's future growth, competi416 indiana health law review scribes the group's inception and objectives: can important initiative,. led by .industry; has been set up together with the european commission. a group of 53 european stakeholders, composed of industrial ·and academic experts, has established a european technology platform on nanomedicine. the first task of this high level group was to write a vision docu­ ment for this highly future-oriented area of nanotech­ nology-based healthcare in which experts describe an extrapolation of needs and possibilities until 2020. beginning of 2006 this platform has been opened to a wider participation (december 2006: 150 ·member or. ganisations) and has delivered a so-called strategic research agenda showing a well elabqrated common european way of working together for the healthcare of the future trying to match the high expectations that nanomedicine has raised so far. [vol. 7:397 the etp's 2005 vision document focuses on three specific areas of nanomedicine: 1) in vitro diagnostics, 2) targeted drug delivery and release (currently in public use), and 3) regenerative medicine;136 the vision doc­ ument sets forth specific goals in each of the three defined areas, to be achieved by the year 2020: 1) nanodiagnostics"[m]ultimodal ~eras for medical imaging," 2) targeted drug delivery "[m]ulti-reservoir drug deli­ very microchips," 3) regenerative medicine "[n]erve regeneration for spinal and limb repair."137 3. considering regulation in its 2005 vision document the etp discussed the need for more re­ search and development of nanomedicine before incorporating new lan­ guage into regulation.138 it stated: [i]t is necessary to put into place measures that identify the hazards as­ sociated with novel nanotechnology-based therapies, characterize the asso­ ciated risks, reduce those risks as far as reasonably practicable, establish a positive risk/benefit balance, and communicate the nature of any residual risks and other relevant safety information to doctors, patients and other key tiveness and sustainability objectives is dependent upon major research and technological advances in the medium to long term.~ european technology platforms, welcome to th_e european technology platforms, available at http://cordis.europa.eu/technology-platforms/ (last visited mar. 12, 2009). 136. etp strategic researcha.genda,supranote 133, at4. 137. id 138. id 2010] nanomedicine 417 stakeholders.139 this language seems to indicate a framework for analysis of regulato­ ry issues that begins with the identification of risks and ends with a reduc­ tion of those risks. 140 crucial to this framework is the dissemination of the risk/benefit analysis to patients, doctors, and decision makers. · this point touches back upon the ethical concerns posed by some who deal with in­ formed consent and a patient's ability to give such consent if the risks of nanomedicine are largely unpredictable or altogether unknown.141 4. focus of research and development the etc has chosen a list of diseases on which to focus research and development of nanomedicine. it states, "[t]his strategic research agenda addresses a choice of diseases, selected by their impact on patients, their prevalence and burden to society, and by the expected beneficial impact nanomedicine is likely to have on them in the near future."142 this pointed commitment to nanomedicine research and development is decidedly absent from efforts in the u.s. iii. analysis: strategy for governance overnanomedicine a. the trouble with regulating too early the first step for providing meaningful regulation of nanomedicine in the future will be a restraint on regulating the technology too early. regula­ tion that arrives before the technology is even fully understood or its poten­ tial fully realized will function to hinder the further development of the technologystifling it at the outset. 1. in the united states currently, nanotechnology in the u.s. is regulated exclusively under the rubric and guidance of the fda.143 "potential applications [for fda approval] are expected to include products such as drugs, medical devices, biotechnology products, tissue engineering products, vaccines, cosmetics, 139. /d. 140. id 141. potential pitfalls, supra note 36. 142. the six diseases mentioned in the strategic research agenda include; cardiovas­ cular disease, cancer, musculoskeletal disorders, neurodegenerative diseases and psychiatric conditions, diabetes, and bacterial and viral infections diseases. etp strategic research agenda, supra note 133 at i 0. . 143. sadrieh & espandiari, supra note 57, at 340 (noting that nanotechnology will be particularly applicable in medicine and health, consumer products, as well as transportation and agriculture). 418 indiana heal1h law review [vol. 7:397 and combination products."144 the fda's regulatory power is far-reaching, encompassing products which "account for twenty-five cents out of each dollar that each american spends."145 given the fda's broad regulatory authority, new nanotechnology will undoubtedly be subject to fda authori­ ty, regardless of how it develops. as such, the fda's approach to nano­ technology regulation is of utmost importance as nanomedicine develops and therefore its policies and systems of regulation should be given careful scrutiny. after careful monitoring of current nanotechnology advancement, the fda maintains that its "existing requirements may be adequate for most nanotechnology products" they would regulate.146· the results of recent re,. search in nano-sized particles, however, indicate that the fda's existing regulatory structures may not adequately address the novel problems that nanotechnology will likely pose. the unexpected behavior of silver nano­ particles discussed earlier demonstrates one of the potential weaknesses in the fda's existing regulations for nanotechnology.147 in the silver nano­ particles research, it was discovered that electrically neutral silver nanopar­ ticles are able to traverse plasma membranes with greater ease than: their electrically-charged counterparts a distinction not exhibited in larger elec­ trically neutral molecules.148 the fact that these nanoparticles ·which, aside from their size -otherwise share the characteristics of larger mole­ cules behave differently than larger molecules indicates that traditional predictive assumptions about the behavior of new technology may not ap­ ply to nanotechnology. this uncertainty regarding the unpredictability of nanoparticles simply due to the newness of the research in the field prompt­ ed. the ntf to express "a lack of confidence in currently used fda product testing methods for safety and efficacy."149 others believe that current regulations, in particular those for combi­ nation products (the category into which nanotechnology is likely to fall within the fda's regulatory guidelines);, are adequate to meet the needs of this emerging technology for the following reasons: "high dose multiples are used in all studies ... ; at least two animal species are used ... ; extensive histophathology is conducted on most organs ... ; functional test to assess if there are effects on specific organ systems ... ; and drug treatments in animals can be for extended periods of time. "15l> these testing requirements for combination products are thought to be rigorous enough to evaluate na144. id. 145. /d. 146. fda nanotechnology faq, supra note 60. 14 7. wilhelmi, supra note 5, at 102. 148. id. 149. ld. (citing fda, nanotechnology: a report of the u.s. food and drug administration nanotechnology task force 16 (2007), available at http://www.fda.gov/ nanotecbnologyltaskforcelreport2007 .pdf 150. sadreih & espandiari, supra note 57, at 344. 2010] nanomedicine 419 notechnology products in the foreseeable future. "as such, we do not ex­ pect that the fda will be· issuing any new guidance to specifically focus on nanotechnology products, as these products will be covered by the existing guidance documents."m 2. in the european union discussion on the topic. of nanotechnology is moving swiftly in the eu as it works toward developing a strategy for addressing issues that arise with the emerging technology. "while knowledge gaps remain regarding the potential risks of nanotechnologies, the [ec] again expressed confi­ dence that existing eu regulation can be applied to this emerging sector, stressing that the challenge ahead lies in their implementation."152 the con­ fidence that the eu places in the current regulation is not, however, given without pause. "knowledge on essential questions such as characterisation of nanomaterials, their hazards, exposure, risk assessment and risk man­ agement should be improved. "153 this improvement, the eu states, will likely stem from the implemen­ tation of the regulations to nanotechnology, not the regulatory language itself.154 "current legislation covers in principle the potential health, safety and environmental. risks in relation to nanomaterials. the protection of health, safety and the environment needs mostly to be enhanced by improv­ ing the implementation of current legislation."155 recognizing that the cur­ rent regulatory language as applied to nanotechnology may be lacking in some cases, it articulates that "commission working groups in charge of coordinating implementation . of legislation are examining on an ongoing basis whether regulatory change on specific aspects is necessary, taking into account the continuously generated information linked with the identified knowledge gaps."156 complementing the above guidelines for nanotechnology regulation in the eu, the etc has articulated additional concerns specifically related to nanomedicine in its "strategic research agenda for nanomedicine."157 the concerns are listed under the heading "providing the environment to 151. id at 349 (both authors of this article are employed by the fda; as such, their opinions are unique and particularly interesting to this topic). 152. nanowerk, european commission sees no regulatory void on nanotechnology. oct. 7, 2008, available at http:/lwww.nanowerk.com/newslnewsid=7617.php (last visited sept. 29, 2009). 153. communication from the commission to the european parliament, the council and the european economic and social committee, regulatory aspects of nanomaterials, com (2008) 366 final, at 1l (june 17, 2008) [hereinafter regulatory aspects]. 154. id. 155. !d. 156. id. 157. etp strategic research agenda, supra note 133. 420 indiana health law review [vol. 7:397 facilitate nanomedicine" in the report. 158 including this section in the overall "strategic research agenda" suggests that the. eu is aw.are that na­ nomedicine may not fit well within the· current regulatory guidelines.159 further, the report specifically addresses the importance of public opinion and reception of nanomedicine.160 another important building block for an environment in favour of nanomedicine is the public acceptance of this novel technology. so far european public opinion as expressed by the media and focus groups is largely · ·positive because nanotechnology promises great ben,. efits for the health and everyday life of people in ad­ dition to economic success. however, one has to be cautious not to fuel the hype about the technology, which in this regulated sector will have «> mature over a prolonged period of time.161 the etc further couches this public opinion concern focusing on the bene­ fits european citizens will receive from nanotechnology. such benefits in­ clude not only an enhanced quality of life because of nanomedicine, but that this enhancement of life will come at much less economic and societal costs.t62 the etc has also discussed the development of intellectual property rights for nanomedicine within the general rules in the seventh framework programme (fp7). 163 the fp7 was designed to group all research initia..; tives in the eu and classify them into four broad categories: cooperation, ideas, people, and capacities. 164 framework programmes are proposed by the european commission and once approved by the european parliament, function as the primary tool through which the eu funds scientific research and development.165 ~·a working group composed of representatives from industry, acade­ mia, and public administration has been established to further elaborate the principles of th~ intellectual property policy of the european technology platform on nanomedicine."166 as of 2006, this group enumerated three "model aims" to "achieve a large participation in the initiative and a fair 158. id at 24. 159. id 160. id. 161. id at20. 162. id. at 11-14. 163. id. at 28; see also european commission. understand fp7, available at http://cordis.europa.eultp7/understand_en.html (last visited feb. 12, 2009). 164. id. 165. id. 166. etp strategic research agenda, supra note 133. 2010] nanomedicine 421 allocation of rights on generated intellectual property" in nanomedicine.167 first, they articulated the goal to streamline the application process for in­ tellectual property rights so as to diminish administrative burdens by per­ mitting only one applicant per patent.168 the second aim states that all research trials will be free from royalties. 169 the third objective sets forth general goals for commercial use of the intellectual property rights.170 b. fixing the focus on research and development the second step toward creating meaningful regulation for nanomedi­ cine will be to shift the current_ focus firmly on research and development of nanotechnology. the eu has noted "a[]s knowledge becomes the critical factor for implementation and, eventually, legislation, targeted actions in a number of areas and at different levels, particularly in the field of research and development ... [are] a.matter ofpriority."171 the eu further vows that "[t]hey will take into consideration work that has been carried out ... at [the] national and internationallevel."172 by not limiting its focus solely to the research and development of nanomedicine only in the eu specifically, it will be better able to facilitate "a rapid improvement of the scientific know­ ledge bas[e]."173 similarly, the fda has indicated a focus on nanotechnology research and development in the ntf report, stating "[r]apid developments in the field mean that attention to· the emerging science is needed to enable the agency to predict and prepare for the types of products .. .in the near fu­ ture."174 they go on to describe "the need for timely development of a transparent, consistent, and predictable regulatory pathway."m the u.s. and the eu shotild proceed cautiously, though, to ensure that the emerging science of nanomedicine is more completely understood be­ fore regulations are crafted. failing to comprehend the science learned through nanomedicine research and development could lead to regulation that arrives too early. this early arrival of regulation could potentially in­ hibit the future of nanomedicine and stifle its development. 167. /d. 168. /d. 169. ld. 170. ld. 171. regulatory aspects, supra note 153, at 11. 172. ld. 173. jdat 8. 174. ntf report, supra note 80, at ii. 175. ld 422 indiana heal til law review [vol. 7:397 c. dealing with the ethical conundrum surrounding the unknown in na­ nomedicine the etp raises the question of a new line that might one day need to be drawn between medical treatment and human enhancement.176 the fda has also recognized the presence of such ethical considerations.177 ·assume patient x suffered some blindness as a side effect to the tumor. not only can patient x's tumor be cured by nanomedicine, so too can her blindness. what if, however, her vision is not only repaired by the nanites, but also enhanced in some way. 178 considerations such as this pose interesting and complex ethical issues over both the technology and its eventual uses. 1. contemporary comparison to a medical and ethical dilemma nanomedicine is the most recent newcomer in a long line of medical topics that are steeped in ethical considerations. the most clear ethical is­ sue to parallel nanotechnology is stem cell research and development. stem cell research has faced a great deal of ethical backlash since the first human embryonic stem cells were cultured in 1998.179 like nanomedicine, stem cells are unique and beneficial because their eventual use and application in the medical environment are limitless. 180 stem cells, particularly embryonic stem cells, are "undifferentiated cells that have the ability to form any spe­ cific adult cell."181 furthermore, stem cells offer insight into human developmental events that cannot be studied directly. this insight could provide medical understanding of human de­ velopment with potential clinical significance for pre­ venting or treating birth defects, infertility, or pregnancy loss, as well as ultimately leading to the prevention or treatment of abnormal human develop­ ment. finally, stem cells could provide a valuable source of transplantable cells and tissues for repair and regeneration, ushering in a brand new era of re176. etp strategic research agenda, supra note 133 at 24. 177 .. ntf report, supra note 80, at 4. 178. see etp strategic research agenda, supra note 133 at 24. 179. jordan saltzberg, the current embryonic stem cell research federal funding policy: undue respect to minority ethical considerations?, 29 j. legal med. 505, 505 (2008). 180. /d. at 506 (citing embryonic stem cell research at uw-madison ,available at http:// www.news.wisc.edu/packages/stemcells/facts.html (last visited feb. 13, 2008)). 181. saltzberg, supra note 179, at 506 (stating that embryonic stem cells could theoreti­ cally provide an unlimited supply of adult cells for a variety of uses). 2010] nanomedicine 423 generative medicine. 182 noting the enormous benefits to the overall health of society that the stem cell research offers, it important to identify precisely what opponents to stem cell research find so ethically repugnant. in order for a stem cell to be obtained from an embryo, the embryo must be destroyed. 183 ·~once the fertilized egg is formed [from in vitro fertilization]; natural. cell divisions commence ... [r]oughly five to nine days ... [later], stem cells can be derived from the inner cell mass of the embryo, ... thus destroying the developing organism and any potential for independent life it may have possessed."184 the destruction of the· embryo is the basis for the opponent's argument..., they believe that to end the existence of the fertilized embryo is to end a life.185 this life, they argue, should be regarded with the same protections as a newborn baby or adult. 186 essentially it is the same argument used by opponents of abortion does stem cell research promote ending the life of a being that deserves the full protection of the law? those opposed to stem cell research would argue that if that question cannot be answered with firm certainty, then this research should not receive federal support. not only is the topic of stem cell research sensitive on an ethical level, it is also a charged issue because many do not believe that stem cell re­ search and development should take place with federal money.187 stem cell research will certainly move forward with or without federal money.188 if the government chooses to not invest in the research and development, then it will have no ability to regulate the research essentially handing over all power to the private sector.189 "an 'unlegislated, commercially driven world' of hesc [human embryonic stem cell] research could lead to ' un­ safe, black market ·conditions,' and erode respect for human embryonic stem cells, the very respect opponents of such research stress and which erosion could be protected against by federal regulation."190 182. id (citations omitted); 183. id 184. id. at 507. "[this report] summarizes some of the more interesting and significant recent developments . . . both in the basic science and medical applications of stem cell research and in the related ethical, legal, and policy discussions." a report of the president's council on bioetidcs, monitoring stem cell research 2 (2004), available at http://www.bioethics.gov/reports/stemcell/pcbe _final_ version_ monitoring_ stem_ cell_ research. pdf (focusing on the ethical, legal, scientific, and medical developments so "that the president, the congress, and the nation may be better informed as they consider where we should go in the future." id.) 185. saltzberg, supra note 179, at 512. 186. ld 187. id. at 505. 188. id. at 517. 189. id 190. id. (quoting carly goldstein, note; dipping into uncle sam's pockets: federal funding of stem cell research: is it legal?, 11 b.u. pub int. lj 229, 256 (2002)). 424 indiana health law review [vol. 7:397 2. creation of a task force on ethical considerations the u.s. and the eu should consider creating task forces to analyze and monitor the ethical considerations surrounding nanomedicine. as with stem cell research, "[e]ven ... those who favor [the] research.~-. [have] questions about its proper limits and the means of establishing and enforc­ ing those limits through meaningful regulation."191 these task forces should be charged with determining what these "proper limits" will include and how nanomedicine can be developed and implemented in the future. n. conclusion though nanotechnology and nanomedicine are still firmly situated in the research and development phase, the united states and the european union have both decided to preemptively examine this emerging technolo­ gy. both countries are proceeding cautiously, however, with regard to regulation of this new technology. through adoption of ''wait and see" ap­ proaches, the nations will be better situated to meaningfully deal with and regulate the technology once the science is fully understood, and there is a clear defined direction in which the technology will be used. it will not be until these scientific advancements occur that the gov­ ernments will be able to adequately see the limitations of the application of current regulatory structures already in place as they apply to nanotechnol­ ogy and nanomedicine. once these limitations are adequately realized, it will be possible for meaningful regulation to follow. the future of mea­ ningful regulation will only stem from careful monitoring of the research and development of nanotechnology. though some of the current regula­ tions might adequately govern parts of nanotechnology and nanomedicine in the future, it is likely that these regulations will not be able to address all of issues as most are not yet known. in addition to focusing on the science of nanomedicine, the united states and the european union should consider creating ethical task forces. these task forces would be charged with monitoring potential ethical issues surrounding the eventual uses for nanotechnology and nanomedicine. they will likely have to tackle such issues as nanomedicine uses for human en­ hancement in addition to countless ethical considerations that have not been 191. a report of the president's councll. on bioetincs, monitoring stem cell research 6 (2004), available at htlp:/lwww.bioetbics.govfreports/stemcelll pcbe_final_version_monitoring_stem_cell_research.pdf "much basic and applied research re­ mains to be done if human stem cells are to achieve their promise in regenerative medicine. this research is expensive and technically challenging, and requires scientists willing to take a long perspective in order to discover, through painstaking research, which combinations of techniques could ... be successful." id. at 140 (noting that this could not be accomplished without "strong financial support" from both public and private sources). 2010] nanomediclne 425 imagined or contemplated at this point. much like stem cell research, nanomedicine technology raises specific ethical considerations that must be explored and considered when contem­ plating the regulation of not only its research and development, but also its inevitable use in society. the governments of the united states and the european union both have pivotal roles to play in the regulation of this re­ search. this influence will ultimately determine how nanotechnology de­ velops and is eventually used in society. nanotechnology and nanomedicine have the potential to revolutionize the medical field in many beneficial ways. nanotechnology is quickly moving beyond the walls of laboratories, where it is constrained by theory, and is shifting ever closer to the realm of practical applicability. as this shift occurs, governments of leading nations need to remain watchful over nanotechnology and nanomedicine developments. current regulatory struc­ tures for medical devices and technology may initially be an appropriate platform from which to govern nanomedicine. the technology, however, may quickly outgrow the effectiveness of these regulations. the united states and the european union should continue to employ the "wait and see" approach to nanotechnology and nanomedicine regula­ tion until more is learned from research and development. as the science takes shape, the governments should use specific task forces to pointedly consider the ethical issues surrounding human enhancement and other ethi­ cal issues that develop with the technology. through understanding and preparation on the ethical issues involved, governments will be better able to frame a meaningful regulatory structure for nanotechnology and nano­ medicine. this regulatory structure will determine future societal uses of this technology. the governments of the united states and the european union must remain mindful of the critical role they are to play as some of the most important technology of the future begins to develop. "the deci­ sion ... reach[ed] here today will determine how we will regard this creation of our genius. it will reveal the kind of people we are; what ... [we are] des­ tined to be."192 192. star trek the next generation: the measure of a man (paramount television broadcast february l3, 1989). michele mekel michele mekel, j.d., mha, mba, is an assistant professor at the southern lllinois university (siu) school of law, with a cross appointment in the siu school of medicine's department of medical humanities. at siu, she is a member of the center for health law and policy and the faculty advi­ sor for the journal of legal medicine. mekel has served as the executive director of the institute on biotechnology and the human future and as as­ sociate director of the center on nanotechnology and society-both at chicago-kent college of law. additionally, mekel has been: a summer faculty member at asian university for women in bangladesh, a fulbright fellow at queen's university centre for health services and policy re­ search in canada; a clerk for the missouri supreme court; and a health care executive with experience in managed care compliance and hospital associ­ ations. a graduate of the university of missouri-columbia, mekel earned a juris doctor (order of the coif), a master's of health administration, a mas­ ter's ofbusiness administration, and a bachelor's of journalism. during law school, she served as editor-in-chiefofthe missouri law review. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i putting theory into practice: thoughts from the trenches on developing a doctrinally integrated semester-in-practice program in health law and policy michele mekel, j.d., m.h.a., m.b.a.* i. introduction .•..••••....••.......•....••••••••••......•...•••..•..••••••.••.•.....••....••• 506 ll. increasing focus on experiential learning in law school·················································································· 507 a. calls for change in legal education ........................................ 507 b. intensive experiential learning in legal education ................. 508 iii. devewping a high-credit, integrated health law field i practicum program: an overview of and lessons learned through siu's health law & policy semester-in-practice program •••••••••••••••••••••••••••••••.••••••••••••••..••••••••••••••••••••••••••••••••••••••• 509 a. individualized student learning plans and related assessments ............................................................................ 510 b. inclusion of a classroom component and doctrinal course integration ............................................................................... 512 1. practicum classroom component ..................................... 512 2. concurrent doctrinal course offerings ........................... 513 c. time tracking and guided reflection ..................................... 514 d. developing practicum partnerships and ensuring quality control ..................................................................................... 515 1. training the trainers ........................................................ 515 2. playing match maker ........................................................ 518 e. stqffing ..................................................................................... 519 n. conclusion .................................................................................. 519 *assistant professor of law, southern illinois university school of law; school of medi­ cine, department of medical human1ties, siu school of medicine. the author would like to thank artie berns for his research assistance in the preparation of this article. 506 indiana healtii law review [vol. 9:2 i. introduction with the employment market for attorneys currently in a subpar state, 1 legal employers have the attention of both law students and law schools, and these employers are demanding practice-ready practitioners? in re­ sponse, law schools are turning increasingly to experiential learning oppor­ tunities of various types.3 for law schools with concentrations, certificate programs, or centers of excellence, experiential learning presents synergies upon which to capitalize in offering students specialized, hands-on training that matches their interests and makes them more attractive employment candidates upon graduation. through its health law program and the southern lllinois university ("siu") center for health law and policy,4 siu school of law has recent­ ly dovetailed its health law and policy expertise and its commitment to pre­ paring practice-ready practitioners through experiential learning with the creation and launch of the siu health law & policy semester-in-practice program ("siu program"), a full-time, semester-long student immersion in 1. see, e.g., william d. henderson & rachel m. zahorsky, the paradigm shift: the law school bubble, a.b.a. j., jan. 20i2, at 30; debra cassens weiss, legal field is na­ tion 's most difficult industry for job placement, employment website says, a.b.a. j. (sept. 6, 20 ii), http://www.abajoumal.com/news/article/legal_field_is_nations_ worst_industry _ forjob_placement_employment_website_; nathan koppel, bar raised for law-grad jobs, wall st. j., may 6, 2010, at a3; see also william henderson, the hard business problem facing u.s. law faculty, nat'l law journal's law sch. review blog (oct. 31, 201i, 12:39 pm), http://legaltimes.typepad.com/lawschoolreview/20 11/1 o/the-hard-business­ problems-facing-us-law-faculty.html?cid=6a00d83451d94869e20154368c8aa4970c#tp. 2. see, e.g., david segal, what they don't teach law students: lawyering, n.y. times (nov. 20, 20i1 ), http://www.nytimes.com/2011/11/20/businesslafter-law-school­ associates-leam-to-be-lawyers.html?pagewanted""''ll; rachel m. zahorsky, aba urges law schools to adopt more practical training for law students, a.b.a. j. (aug. 9, 2011), http://www.abajoumal.com/newslarticle/aba_urges_law_schools_to_adopt_more_practical_t raining_ for_ students/ (discussing resolution 1 ob, from the new york state bar association, which was adopted by the american bar association (aba) house of delegates at the aba's 2011 annual meeting). see infra note 6 and accompanying text. 3. see generally robert a. parker & sue schechter, the ugly duckling comes of age: the promise of full-time field placements (2011), available at http://ssm.com/abstract=1886509; karen sloan, action on law school reform, nat'l l. j .• aug. 22, 2011, at 1, 6-7; patrick g. lee, law schools get practical, wall sr. j .• july 11, 2011, at bs, available at http://online.wsj.com/article/sb100014240527023047935045 764340741726497l8.html. 4. sill's health law program features an opportunity for students to participate in the editorial preparation of and contribute commentaries and case briefs to american college of legal medicine publications, including the journal of legal medicine and legal medi­ cine perspectives; an m.d./j.d. program; numerous outreach and educational activities throughout the year, including a distinguished lecture series and a health policy symposium now in its· fourteenth year; the national health law moot court competition; professional responsibility day, during which first-year law and medicine students collaborate on ad­ dressing professional ethical dilemmas; and a wide range of health law and policy course offerings, including the health law & policy semester-in-practice program. 2012) developinganintegratedprogramjnhealmlaw and policy 507 a designated health law and policy practice setting.5 section ii of this arti­ cle briefly explores trends in legal education related to experiential learning. section ill provides some guiding principles for developing a doctrinally integrated health law and policy field practicum program through the lens of the siu program. section n concludes. ii. increasing focus on experiential learning in law school a. calls for change in legal education at its 2011 annual meeting, the american bar association ("aba") house of delegates adopted a resolution ''urg[ing] legal education providers to implement curricular programs intended to develop practice ready law­ yers, including, but not limited to enhanced capstone and clinical courses.'.6 while perhaps one of the most urgent and direct official appeals for prac­ tice-oriented legal education, this "call to relevance in legal education"7 is far from the first. the maccrate report in 1992,8 the subsequent revision of curriculum standards 302(b)(l) and 305 of the aba standards and rules of procedure for approval of law schools,9 the carnegie report of 2007,10 and 2007's best practices for legal education11 all previously 5. siu school of law also currently offers semester-in-practice programs in the areas of criminal law, and state and local government law. in addition, siu school of law offers semester-long placements through its judicial and public interest externship programs. 6. am. bar ass'n, resolution lob (2011), available at http://www.abajournal. com/files/10b_2011.pdf. in a related vein, at the start of2012, the new york court of ap­ peals amended its bar admission rule related to legal education to provide more flexibility for clinical education, including field placement programs. see 22 n.y. cr. r. § 520.3 (mckin­ ney 2012), available at http://www.nylj.com/nylawyer/adgifs/decisions/011312rules.pdf; see also joel stasbenko, new requirements for bar exam stress clinical education, n.y. l.j., jan. 13, 2012, available at· http://www.law.com/jsplarticle.jsp?id=1202538196535 &slreturn= 1. 7. keith a. findley, rediscovering the lawyer school: curriculum reform in wis­ consin, 24 wise. int'l l.j. 295, 306 (2006) (using this phrase to encapsulate earlier ap­ peals). 8. a.b.a. sec. legal educ. & admissions to the bar, an educational continuum: report of the task force on law schools and the profession: narrowing the gap (1992) [hereinafter maccratb report]. 9. a.b.a. sec. legal educ. & admissions to the bar, standards and rules of procedure for approval of law schools, curriculum, standard 302(bx1) (2010) (re­ quiring that approved law schools "offer substantial opportunities for . . . real-life practice experiences, appropriately supervised'') [hereinafter aba standards]; aba standards, study outside the classroom, standard 305 (addressing field placement programs). see james h. backman, where do externships fit? a new paradigm is needed: marshalling law school resources to provide an externship for every student, 56 j. legal educ. 615, 615-16 (2006). 10. william m. sullnan et al., educating lawyers: preparation for the profession of law (2007) [hereinafter carnegie report]. 11. roy stuckey et al., best practices for legal education: a vision and a road map (2007) [hereinafter best practices]. "'there is no more effective way to help students understand what it is like to be a lawyer than to have them •.. perform the tasks that 508 indiana health law review [vol. 9:2 stressed the import of applied legal training in the modem law school cur­ riculum. and, while inclusion of experiential learning is not at all a novel concept within the legal academy/2 the emphasis on expanding and truly integrating practicum programs with doctrinal academics, however, is rising to the fore. b. intensive experiential lea_rning in legal education in response to the continued "call[ s] to relevance,"13 "experiential learning," the hottest buzzword in legal education today, is generally de­ fined as a type of "learning undertaken by students who are given a chance to acquire and apply knowledge, skills and feelings in an immediate and relevant setting."14 this definition, based on the experiential learning mod­ el developed by learning theory scholar david kolb, along with his col­ league roger fry, interweaves four elements: (1) "concrete experience," (2) "observation and reflection," (3) "formation of abstract [or theoretical] concepts," and ( 4) "testing [or applying these theories and concepts) in new situations."15 these elements, in turn, form a feedback loop through which learning occurs.16 in line with kolb's model, the best practices report explains that ef­ fective utilization of experiential learning in legal education requires teach­ ing methodologies to "integrated theory and practice by combining academic inquiry with actual experience."17 as a result, bona fide experien­ tial learning can take various forms in the law school context: from class exercises, to clinics, to full-time field placements. the latter form is the most intensive, including externships, curriculum-integrated field practi­ cums, and co-ops. while full-blown co-op programs are relatively rare in the realm of legal education, they have become the calling card of a few schools, including northeastern university school of law18 and the earle lawyers perform and observe practicing lawyers at work." id at 170. 12. see parker & schechter, supra note 3, at 2 (discussing legal education's appren­ ticeship roots and the rise of clinical programs in law school education beginning in the 1960s). 13. findley, supra, note 7, at 306. 14. mark k. smith, david a. kolb on experiential learning, encycwpedia of informal eouc., http://www.infed.org/biblio/b-explrn.htm (last visited june 14, 2012). 15. /d.; see also best practices, supra note 11, at 166 (citing steven hartwell, six easy pieces: teaching experientially, 41 san diego l. rev. 1011, 1013 (2004)) (discussing the four elements). 16. id. 17. best practices, supra note 11, at 165. "both the field clinical model and aca­ demic legal teaching are, from a kolb[ian] perspective, incomplete learning models because both typically lack two stages of the learning sequence. the clinical field model lacks the theory stage and application. the academic model lacks experience and reflection." hart­ well, supra note 15, at 1015. 18. northeastern university school of law's year-round co-op program, operated through the school's office of cooperative legal education, has been in place for more than forty years and features "four quarters of full-time employment." cooperative legal educa20 12) developing an integrated program in health law and policy 509 mack school of law at drexel university/9 which have distinguished themselves by setting the bar for cooperative legal education. a modified approach to cooperative learning, however, is becoming prevalent. a 2010 survey by robert parker, of the university of the pacific's mcgeorge school oflaw, and sue schechter, ofthe university of california's berke­ ley school of law, found that 60 of the then-200 aha-approved law schools "offered full-time field placements."20 to be successful, however, these off-campus, full-time practicum programs require considerable, ongo­ ing commitment and integration at all levels-mission, vision, and re­ sources. while most law schools are not prepared for the fundamental programmatic obligations and alterations associated with a full-fledged co­ op program/1 developing a limited, doctrinally integrated practicum pro­ gram that capitalizes on an existing area and critical mass of doctrinal ex­ pertise, such as health law, may offer some schools a natural, effective, and unique approach to expanding and integrating robust experiential learning. siu has opted for this approach in its areas of excellence, including health law and policy. iii. developing a high-credit, integrated health law field practicum program: an overview of and lessons learned through sid's health law & policy semester-in-practice program linking full-time field placements with doctrinal coursework, the siu health law & policy semester-in-practice program provides an applied capstone to participating students' legal education by combining health law courses with unpaid, semester-long field placements under the supervision of attorneys working in health law and policy at sites, such as hospitals and health systems, medical schools, health-related government agencies, and health care associations. the third-year students enrolled in the siu pro­ gram work full days at their assigned placement site, monday through thursday, for which they earn up to nine hours of credit in a single semes­ ter, awarded on a modified pass-fail basis?2 the goal is to reinforce, augtion program, ne. unn. sch. of law, http://www.northeastem.edullaw/co-op (last visited june 14, 2012); see also roger i. abrams, symposium: legal education at the threshold of the new millennium, co-op program, 15 st. john's j. legal comment. 295 (2001). 19. the earle mack school of law at drexel university features a one-semester field placement. hands-on learning; the co-op program, earle mack sch. of law at drexel unn., http://earlemacklaw.drexel.edu/academics/co-op/ (last visited june 14, 2012). 20. parker & schechter, supra note 3, at 13-14,24. 21. for example, northeastern's co-op program: "cost[] ... more than $800,000 a year" as of 2001; requires a very substantial staffing complement, which, in 2001, entailed six full-time employees, including three attorneys; "consumes an enormous amount of stu­ dent and administrative time;" and ''presents quite a logistical challenge," mandating an academic year based on the quarter system. abrams, supra note 18, at 296-98. 22. the siu program calls for forty-seven hours of approved practicum work to be completed by the student for each credit hour awarded. the program also utilizes a 510 indiana health law review [vol. 9:2 ment, and integrate law students' ''knowledge, know-how, and ethical judgment"23 in an area of interest to them-the practice of health law and policy-and to, thereby, provide a bridge from legal education to legal practice.24 a. individualized student learning plans and related assessments the practicum is tailored for each student and placement site, within broad guidelines, in order to achieve practical, personalized, and pedagogi­ cally effective learning outcomes through the creation, at the commence­ ment of the semester, of an individualized "learning plan" jointly prepared by the supervising attorney and the student. focused on the overarching categories of applied lawyering skills, professional conduct and identity, and legal ethics,25 the learning plan requires articulation of specific objec­ tives tied to measurable activities and deliverables that are to be assigned and completed during the semester in each of the categories. in each area, the activities and deliverables must include observation, application, and assessment components. within the first week of the placement, the faculty program director reviews and, if necessary, works with the student and su­ pervising attorney to revise the learning plan to ensure: outcomes orienta­ tion, rigorousness, balance between hands-on and observational learning, variety of assignment types, breath of legal skills to be employed, profes­ sionalism and ethics development opportunities, and plausibility and appro­ priateness of the volume of assignments. throughout the semester, the student, supervising attorney, and faculty director revisit the learning plan, which serves as the touchstone for measuring student progress. specifical­ ly, at the midpoint and endpoint of the practicum, formalized, in-person reviews26 are conducted with the student by both the field-supervising at"plus/minus" pass-fail grading system. 23. the author here applies a twist to the notion stated in the carnegie report that ''what the [traditional] academic treatment oflaw works hard, for legitimate intellectual rea­ sons, to keep separate [are] knowledge, know-how, and ethical judgment" see carnegie report, supra note 10, at 81. the purpose of the siu program is to build, integrate, and transfer students' stable of substantive knowledge, practical skills, and professional values. 24. in addition, the program offers a "cure" to the .. 3l malaise" that is pervasive among students in their final year of law school. see, e.g., best practices, supra note ii, at 153 (citing mitu gulati et al., the happy charade: an empirical examination of the third year of law &hool, 51 j. legal eouc. 235, 238 n.4 (2001)); edward rubin, sympo­ sium: what's wrong with langdell's method and what to do about it, 60 vand. l. rev. 609, 66().-61 (2007). such "[c]apstone courses ... represent a ... serious effort to hold the students' interest." id. at 661. 25. these areas of focus tie directly into the "three apprenticeships" that law students require in order to be prepared for practice, and, therefore, that law schools should stress; these ''three apprenticeships" have emerged from the major modern critiques oflegal educa­ tion. see maccrate report, supra note 8; carnegie report, supra note 10; best practices, supra note ii; see also jerry r. foxboven, beyond grading: assessing student readiness to practice law, 16 cumcall. rev. 335,337-41 (2010). 26. such meetings, which take time and other resources, could be conducted telephon­ ically or using video conferencing, while still complying with aba standard 305(e)(5). see 2012] developing an integrated pro,oram in health law and policy 511 tomey and the faculty program director, using the learning plan and a "student performance review,'.27 the latter of which is akin to a traditional employment performance review, as guideposts.28 in line with the midterm evaluation, revisions to the learning plan are made, if necessary. addi­ tionally, students conduct and submit to the faculty director written self­ assessments, analyzing their own learning, professional growth, and specif­ ic and overall performance, at both the midpoint and endpoint of the semes­ ter.29 both self-assessments are accompanied by selected student work product, with the permission of the site supervisor and appropriate redac­ tions, as needed. aba standards, standard 305(ex5), supra note 9 (requiring ''periodic on-site visits or their equivalent by a faculty member if the field placement awards four or more academic credits (or equivalent) for field work in any academic term"). in-person meetings, however, stress their import and are preferable-at least initially-in starting a program and develop­ ing working relationships with placement sites and field supervisors. 21~. program directors may also choose to adopt or adapt student evaluation fonns already in use in their legal clinic(s) or extemship program(s), if applicable. additionally, program directors may wish to consider the nine competency areas set forth by professor alice alexander and professor jeffery smith, both then of northeastern university's school of law, in their article, "a practical guide to cooperative supervision for law students and legal employers." alice alexander & jeffery smith, a practical guide to cooperative supervision for law students and legal employers, 29 law off. econ. & mgmt. 207, 21617 (1998}. these general competency areas include: research ability, legal analysis, intel­ lectual capacity, writing skills, oral communication skills, judgment, responsibility, and cli­ ent relations. id.; see also infra note 25. regardless, the evaluation form and criteria should be made available, prior to the start of the practicum, to both field supervisors and students in order to ensure that expectations are transparent from the start. 28. this process is in line with aba standard 305(ex3), which calls for "a clearly articulated method of evaluating each student's academic performance involving both a fac­ ulty member and the field placement supervisor." this method of assessment, when framed in terms of competence or proficiency level, lets students know how they are. performing with regard to their professional development in specific, core lawyering skills and com­ portment. see best practices, supra note 11, at 245; aba standards, supra note 9. for a formalized and effective mid-semester extemship review protocol, see laurie barron, learning how to learn: carnegie's third apprenticeship, 18 clinicall. rev. 101 (20ll). as discussed in detail by barron, well-conceived, formal review processes coupled with student self-assessment during the placement experience teach students how to effectively and appropriately interact with supervisors and actively participate in their professional de­ velopment. see generally id. 29. self-assessment is "directed inquiry'' in which students identify ''the basic compe­ tencies essential to becoming an effective lawyer[,] . . . measure their performance against those ideals, and then direct their focus more specifically on those [that] they must develop and/or refine." alexander & smith, supra note 27, at 222-25 (providing a list of practical legal skills that can be summarized as research, analysis, writing, speaking, interpersonal, and professionalism). "through ... [s]elf-[a]ssessment, students can use [the identified] competencies as points of reference from which to examine and track progress of their prac­ tical legal skills development." id. at 225. for ideas on productively directing and employ­ ing student self-assessment in such a program, see laurie barron, learning how to learn: carnegie's third apprenticeship, 18 clinical l. rev. 101 (2011) (paying particular atten­ tion to the appendices). 512 indiana health law review [vol. 9:2 b. inclusion of a classroom component and doctrinal course integration the goal of siu' s capstone program differs somewhat from stand­ alone externships and clinical experiences30 in that it is practice-area specif­ ic and doctrinally integrated. this tracks with the "best practices" report's calls for "more than simply training students to perform mechanical lawyer­ ing ~sks.'.j 1 as a result, the program features a full-time health law and policy field placement coupled with a robust classroom component and concurrent courses in substantive health law. ·1. practicum classroom component in addition to skills building through daily performance of assign­ ments and observation of health law and policy practice, students partici­ pate in a contemporaneous, seminar-style classroom component, taught by the program director, who is a faculty member with health law and policy expertise. 32 with the goals of integrating substantive legal concepts and policy with applied legal skills, intensifying meaningful reflection, promot­ ing ongoing knowledge transfer among students, and enhancing profession­ al problem solving, ethics and identity, the classroom component includes: • a day-long, orientation at the start of the semester to identify and articulate measurable learning objectives, provide a primer on key health law concepts, address commonly arising ethically issues, cover profession­ alism standards, review legal research skills, and discuss program docu­ mentation and reporting requirements; • periodic course meetings among the faculty director and all en­ rolled students;33 • group field trips to observe health law and policy in actual opera­ tion·34 and ' 30. "clinical teaching only rarely touches on legal theory." hartwell, supra note 15, at 1015. 31. best practices, supra note 11, at 17. 32. this seminar, held contemporaneously with the high-credit field placement, complies with the requirements set forth in aba standard 305(ex7), mandating: opportunities for student reflection on their field placement experience, through a seminar, regularly scheduled tutorials, or other means of guid­ ed reflection. where a student can earn four or more credits (or equiva­ lent) in the program for fieldwork, the seminar, tutorial, or other means of guided reflection must be provided contemporaneously. aba standards, supra, note 9. 33. while the siu program features in-person meetings, these meetings could be con­ ducted via conference call, video conferencing, or online. 34. given tbat the field placements for the siu program are currently concentrated in springfield, lllinois, the state capital, there are numerous observational opportunities related to applied, high level health law and policy, including legislative session, legislative hear­ ings, and oral argument at the lllinois supreme court. 20 12] developing an integrated program in health law and policy 513 • an end-of-the-semester peer teaching35 exercise in which each student presents to the class his or her placement site, its health law and policy functions, the ethical issues that arose during the semester, the law­ yering skills the student honed through the practicum, and key lessons learned about the practice of health law and policy. 2. concurrent doctrinal course offerings over and above the mandatory classroom portion of the practicum, participating students are eligible to enroll· in doctrinal courses that com­ plement their placements, such as public health law and/or bioethics and the law, allowing them to earn up to a total of fifteen credits during the semes­ ter. the courses, which are offered on fridays or in the evenings, work around the students' placement schedule and parlay the law school-medical school collaboration36 and distance-learning technologies.37 most critically, offering such substantive health law and policy coursework in parallel with the experiential placement is designed to integrate, enhance, and enrich stu­ dents' appreciation for and transference38 of theoretical materials by "help[ing] students to understand the law in context, ... see the bigger im­ plications of the law, and ... critically evaluate ... institutions and the way they affect . . . [social policy]. "39 35. see generally keith j. topping, trends in peer learning, 25 eouc. psychol. 631, 643 (2005). not only does peer teaching hone students' oral communications skills, but it also requires serious reflection on the immersive practical experience, their growth as a law­ yer-in-training, and the health law and policy arena. moreover, it enables knowledge trans­ fer among students of setting-specific experiences, given that placement types vary. 36. as the majority of the placements are co-located in springfield, illinois, where the siu school of medicine has a primary presence, students can access a designated class of­ fered by medical school faculty with law school cross-appointment. in addition, the medical school offers both a location for and the technology through which law students enrolled in the program can access a substantive health law course based at the law school via an inter­ active, real-time video linkage. 37. an aba standard 306-compliant, distance-learning, doctrinal health law course is also available to program students through the use of technology that makes interaction among class participants at multiple locations fully interactive in real time. see aba standards, standard 306 (setting forth the requirements for credit-eligible distance­ learning courses), supra note 9. as the professor teaching the doctrinal course, offered via distance learning, and as the program director conducting the classroom component of the practicum and performing regular field placement site visits, the author travels between the law school and medical school locations frequently during the semester, which allows for alternation between the sites' receipt of in-person instruction for the distance-learning-qualified doctrinal course. 38. '"transfer' refers to a student's ability to employ skills in one context that have been learned in a different context." david a. binder & paul bergman, taking lawyering skills training seriously, 10 clinical l. rev. 191, 197 (2003). 39. findley, supra note 7, at 314. this is based on "[f]undamental principles oflearn­ ing theory [that confirm] that, 'when cognitive studies are accompanied by active engage­ ment in their application to concrete problems, a likely result is fuller comprehension, better retention, and more apt recall of the cognitive material."' !d. (quoting frank michelman, 514 indiana healm law review [vol. 9:2 c. time tradcing and guided reflection preparing students to be competent and thoughtful professionals through practice-oriented experiences, even when combined with a class­ room component and augmented with concurrent substantive legal course­ work, is insufficient. to provide true and higher learning, reflection must also occur, according to kolb's circular model of experientiallearning.40 this need for reflection has also been captured in aba standard 305( e )(7), which calls for: opportunities for student reflection on their field placement experience, through a seminar, regularly scheduled tutorials, or other means of guided reflec­ tion. where a student can earn four or more credits (or equivalent) in the program for fieldwork, the sem­ inar, tutorial, or other means of guided reflection must be provided contemporaneously.41 by requiring time. and activity tracking and guided reflection, profes­ sors overseeing experiential practicums can enable students to step back and consider the cognitive and affective aspects of relevant issues related to their field placement. through exercises, such as reflective journaling with the use of directed prompts, students can: evaluate key issues inherent in legal practice, including practice within a substantive area; such as health law and policy; explore· the various roles and professional norms of lawyers in general, as well as within a specialty, such as health law and policy; con­ template their specific and overall skills performance and professionalism; develop ari awareness of their underlying perceptions of and reactions to the practicum experience; and explore their professional interests within legal practice, including within the given subspecialty.42 as such, the siu. program has incorporated tried-and-true methods that are part of many extemship programs, including: • weekly, ''billable-hours"-styled activity reporting to ensure stu­ dents track their accrual of hours in order to meet the credit-hour require­ ment for the semester,43 to acclimate students to time accountability methods used in practice, and to memorialize the breadth of activities in which students are engaged as part of their placement; the parts and the whole: non-euclidian curricular geometry, 32 j. legal educ. 352, 353-54 (1982)); see also section ii.b., supra. 40. see smith, supra note 27, and accompanying text. 41. aba standards, standard 305(ex7), supra note 9. 42. see generally best practices, supra note 11, at 173; gerald hess & steven f'rmdland, techniques for 'i'eacjdnglaw 109-10 (1999). 43. see, supra note 22. 2012] developinganintegratedprograminheal1hlaw and policy 515 • bi-monthly, prompt-based reflective joumaling assignments to complete the experiential learning cycle· and encourage higher-level learn­ ing, as well as to build self-assessment skills; and • an end-of-the-semester final report, which includes an overall accounting of qualified hours completed, observations, assignments and deliverables completed, lawyering skills ·used and improved, and ethical issues encountered, as well as an overall self-assessment and placement site assessment. d. developing practicum partnerships and ensuring quality control at the heart of successful intensive learning programs that utilize field placements is the formation of long-term partnerships between practicum sites and the law school, which, in twn, hinge upon strong working rela­ tionships between the field supervisors and the faculty program director. critical not only to securing and maintaining a sufficient number and varie­ ty of placement opportunities, such ongoing relationships also ensure "qual­ ity control'' of and among the practicums. because students are assigned to different sites, the program experi­ ence will vary among students, due, in part, to the specific placement type. this is highly desirable, as providing a student-centered experience is part and parcel of the siu program's goals. at the macro level, however, a baseline of consistency across placements is necessary to ensure structured, rigorous, applied experiences are provided to each student and at each site. this is in both the students' and. school's interests because significant credit is being awarded through the program toward the law degree. moreover, "[i]f a full-time field placement experience is not positive, it impacts a much greater part of the student's law school career than does a ... part­ time extemship, clinic[,] or podium course.'m 1. training the trainers therein lies both the intended fortune and potential folly of off-site, full-time practicums in legal education: the day-to-day instruction of stu­ dents occurs outside of the law school walls and beyond the direct control of vetted law faculty.45 rather, as the practicum portion of the siu pro44. parker & schechter, supra note 3, at 8. 45. proponents of experiential leaming-especially those utilizing off-site place­ ment&-underscore that, •'to realize the potential ... , we must decrease the tight control of legal educators over learning." brook k. baker, learning to fish, fishing to learn: guided participation in the interpersonal ecology of practice, 6 clinical l. rev. 1, 8 (1999). doing so provides the added benefit that the faculty director is then free to assume a rela­ tionship of "pedagogical purity" with the student, such as exists in traditional law school classes but not in in-bouse clinical courses; as a result, the faculty member "can focus solely on the student and [the student•s] concerns" in navigating and learning through the practi516 indiana health law review [vol. 9:2 gram provides direct training in professional practice, approved field super­ visors at the assigned placement sites are charged with the daily instruction and oversight of students.46 alice alexander and jeffery smith define the vital role of field super­ vising attorneys in the legal practicum context as "directing the completion of work assigned to ... students" through the provision of "guidance, con­ structive criticism, and a final critique of the student's work product in a timely and meaningful fashion.'.47 as such, field placement attorneys over­ seeing students must have both time for and expertise in effectively provid­ ing such direction48 and feedback49 to students. while the existence of the prior is within the exclusive discretion of the placement site and supervising attorney, 5° the program director can and should aid in building the latter in a number of ways, including: • designating a single attorney at each site who serves as the field supervisor for a given student or students;51 cum experience. laurie baron, learning how to learn: carnegie's third apprenticeship, 18 cunicall. rev. 101, 113 (2011). 46. this directly and formally achieves the edict, in both the aba standards and the best practices report, to involve practitioners in the instruction of law students. see aba standards, standard 403(c), supra note 9; best practices, supra note 11, at 157. 47. alexander & smith, supra note 27, at 208 (setting forth a contemporary, coopera­ tive supervisory model for law student externships). 48. "direction refers to the [field supervisor's] responsibility for adequately defining and explaining work assignments." id. at 212. "in providing the necessary [d]irection for successful cooperative supervision, [field supervisors] have a dual task: the first is defining the assignment; the second is exercising control over it" id. 49. "feedback refers to the ongoing process of communicating to the student the [field supervisor's] evaluation of the student's performance." /d. at 215. 1t]he three critical ele­ ments of [ t]eedback are: ( 1) that it be an ongoing, not a static, process; (2) that it be commu­ nicated; and (3) that it involve constructive criticism." id 50. in establishing placement opportunities, it is critical that the program director is upfront with field supervisors about the time commitments of and other responsibilities and requirements related to taking on a practicum student. in addition, the program director must be cognizant of his or her own responsibilities and duties not only to the enrolled students but also to the "'care and feeding' of ... field supervisors'~ who are ''work[ing] for free." michael a. y ameli, an externship program: start it, grow it, improve it, 3 phoenix l. rev. 473,500 (2010). 51. the designated supervising attorney then is responsible for directing and providing feedback to the student, as well as for reporting to the program director. in addition to providing for clear working relations and accountability, such designation gives the student a "go-to" person in the field for any issues that arise during the placement, and helps control work flow so that the student does not experience the pressure of being given unexpected assignments that are not part of the learning plan, which may arise when others at the placement site view the student as a valuable resource for extra projects, including projects that may not be valuable to the law-and-policy related learning that is the goal of the practi­ cum. see generally, alexander & smith, supra note 27, at 214, such designation, however, does not and should not mean that the student is exclusively assigned to or can only work with the designated field supervisor during the placement rather, a variety of relevant as­ signments meet the objectives set forth in the learning plan should be encouraged to provide a well-rounded experience. these assignments, however, should be channeled to though the designated field supervisor. 20 12] devewping an integrated program in health law and policy 517 • providing a detailed, easy-to-use field supervisor manual, which contains a checklist of key dates and deliverables, required program docu­ ments and forms in hard copy and electronic formats, contact information for the faculty director, and an outline of supervisory expectations and pro­ gram objectives;52 • hosting a short-but-informative individual or group orientation session for new field supervisors, prior to the start of the placement; • sending reminders about deadlines and associated deliverables, as well as the import of providing students with frequent feedback on their work product and professional conduct;53 • being available and responsive to placement supervisors via all media, as well as through one-on-one contacts prior to and during the se­ mester; and • offering helpful feedback gathered from the student(s) as to the specific placement, as well as general insights and tips gathered across placement sites. 54 52. excellent resources for those developing field supervisor materials for such programs include: • any externship program field supervisor materials used at the home institution; • the lextem web website and lextem listserv provided by profes­ sor sandy ogilvy of the catholic university of america's columbus school of law and available at lextemweb, catholic univ. of am., http://lextemweb.law.edu/ (with details on subscribing to the listerv, as well as accessing the archives, are included on the website) (last visited june 15, 2012); and • the greater los angeles extemship consortium, known as "glace," which has a website hosted by loyola law school and is availa­ ble at glace home page, http://www.lls.edu/glace/ (last visited june 15, 2012). see also best practices, supra note 11, at 198-206. 53. it is critical that the program director encourage the field supervisorthroughout the semester to provide ongoing feedback directly to the student(s) because, "[w]hile many legal employers generally operate under the 'no news is good news' rule, this silent approval sys­ tem is not the most constructive way for students to measure their progress." alexander & smith, supra note 27, at 215. the best practices report stresses that "guidance and feedback that students receive in experiential education courses influences the quality of the experi­ ence more than any other component." best practices, supra note 11, at 175. specifically, effective and timely feedback benefits the student(s), who can then take corrective action and refine skills; moreover, it also aids the field supervisor, who can subsequently expect to re­ ceive improved work product. see id.; see also binder & bergman, supra note 38, at 202. see generally best practices, supra note 11, at 174-76. in addition, frequent, meaningful feedback also distinguishes practicums from traditional law school classes and further en­ hances their pedagogical value. see generally carnegie report, supra note 38, at 164-65, 173; best practices, supra note 11, at 126. 54. these efforts to prepare, support, maintain ongoing contact with, and offer feed­ back to the supervising attorneys also provide compliance with aba standard 305(ex4), which calls for "a method for selecting, training, evaluating, and communicating with field placement supervisors." aba standards, supra note 9. 518 indiana health law review [vol. 9:2 2. playing match maker a key ''underlying premise of a successful program of practical legal education is that [placement sites j and students provide mutual benefit to each other.''55 this front-end task for the program director involves under­ standing the needs of each vetted placement site, and the skills and interests of qualified applying students, as well as developing and implementing a system through which productive student-placement matches are made. given the import of this initial task, the process for the siu program, which runs the practicums during the fall semester, holds the application process during the prior spring semester with interested second-year stu­ dents submitting a cover letter explaining their interest in the program and placement site-type preference, their resume, and their official law school transcript. applications are then reviewed to ensure that applying students meet program requirements, including: minimum grade-point average, 56 academic standing as a third-year student by the commencement of the placement, 57 and successful completion of program prerequisites. 58 based on their expressed placement-type preferences,59 the faculty director tenta­ tively pairs qualified students with placement sites and contacts field super­ visors to discuss potential placements for the fall. upon receiving placement site participation agreement, the faculty director facilitates inter­ views between the tentatively matched applicants and field supervisors to ensure a fit. after following up with placement site field supervisors, the faculty director then assigns qualified and approved students to placement sites, and students are enrolled in the program with sufficient advance no­ tice to allow them to make arrangements for the fall semester.60 the pro55. alexander & smith, supra note 27, at 211. in addition to the professional duty to "give back" to the profession and serve as mentors, the expected benefit provided by student manpower is a primary reason sites and field supervisors, who are busy professionals with tremendous responsibilities and deadline pressures, agree to such placements in which they guide and train students without remuneration. hence, providing students who are equipped, albeit at a novice level, and motivated to meet the needs of a given site is a core function of the faculty director. 56. the minimum grade-point average requirement for enrollment in the program is 2.6 (based ort a 4.0 scale), as set forth in the southern illinois university school of law rules. id. at art. iv.l.b.(iii.)(b.), available at http://www.law.siu.edu/current%20students/ pdf/clinic%20&%20field%20placement%20rules-excerpted%20from%20sol %20rules %20fot'/o20a y%20 ll-12.pdf (last visited june 14, 20 12). 57. as a capstone course, the program is only open to students in their final year of law school. 58. for example, having taken and passed the professional ethics c<>urse is a prerequi­ site for acceptance into the program. consideration of logical prerequisites and baseline skills is critical to help ensure student success in placements. see, e.g., best practices, supra note 11, at 204. 59. see id. at 203 (stressing student-centered placement assignments). 60. given that the placements are primarily co-located in springfield, illinois, while the law school is located in carbondale, illinois, students are required to obtain alternate housing for the upcoming semester. 20 12) developing an integrated program in health law and policy 519 gram director then communicates with both the field supervisors and the students throughout the summer and holds orientations for both groups just prior to the commencement of the fall semester. e. staffing experiential learning through field placement programs not only re­ quires "reconceptualizing of the law curriculum" but also of "the faculty's roles in it.'.61 although the day-to-day student instruction and supervision occurs offsite by typically unpaid field supervisors,62 aba standard 305( e )(2) mandates that all field placement programs receive "adequate in­ structional resources, including faculty teaching in and supervising the pro­ gram who devote the requisite time and attention to satisfy program goals and are sufficiently available to students.'.63 moreover, interpretation 3054(b) of aba standard 305 states that, "as the number of credits awarded [for a field placement] increases, the level of instructional resources devot­ ed to the program should also increase. ,.64 while the standard and the inter­ pretation provide for tremendous flexibility through their broad language, the more directly linked these programs are with doctrinal specialty areas, and the more they are intended to serve as intensive capstones to students' legal education, the more faculty resources they require. 65 iv. conclusion while building and maintaining a truly doctrinally integrated, high­ credit, capstone practicum program can be resource intensive, it builds the type of bridge to practice that the recent critiques of legal education have urged, and it provides participating students with an advantage in today's very challenging legal employment market. the efforts and resources in­ volved in developing and sustaining such an initiative, however, can be modulated, at least to an extent, when it builds upon an area where the law school already boasts a core competency and critical mass. while the siu health law & policy semester-in-practice program is still-and will con­ tinue, for the foreseeable future, to be-a work in progress, continually evolving and improving, its design and the truly experiential learning gar61. best practices, supra note 11, at 145; see also, supra note 45 and accompanying text. 62. see supra note 50 and accompanying text. 63. aba standards, standard 305(e)(2), supra note 9. 64. aba standards, standard 305, interpretation 305--4, supra note 9. 65. while part of the law school's overarching experiential learn program, each of sill's semester-in-practice programs has a specialty orientation and a doctrinal linkage and, as such, is actively directed by a member of the full-time faculty within the given area of substantive legal expertise. this requires the school to dedicate a significant portion of its limited faculty resources to the operation of these programs. 520 indiana health law review [vol. 9:2 nered through its initiation and early operations may serve the added bene­ fits of informing, if not· encouraging and inspiring, others considering such initiatives. 66 66. there are many ways to set up doctrinally linked semester-in-practice programs that are pedagogically sound and comply with aba standards. see backman, supra note 9. e-health revolution and the necessary evolution of informed consent, the the e-health revolution and the necessary evolution of informed consent jessica berg, jd, mph' i. background .......................... ...... 591 a. informed consent ................... ...... 591 b. rise of e-health...........................594 ii. the consumer e-health universe ....... ........ 595 a. e-health and shared decision making.................595 b. e-health substitutes for clinical encounters......600 iii. implications of the new e-media for informed consent ................................... 605 iv. conclusion ................................. 608 in the past decade the e-health revolution has transformed the practice of medicine. while there has been a great deal of focus on the implications of the development of new e-media 2 for the provision of medical care, less attention has been paid to the implications for informed consent. long considered a core practice in medical ethics, informed consent's framework and role in the internet age is less clear. new mechanisms for information sharing have the potential to transform the traditional practice of both disclosure and consent. 1 interim dean and professor of law, bioethics and public health. case western reserve university. i would like to thank tracy li for her excellent research assistance, the department of bioethics work-in-progress participants for their helpful comments, and sharona hoffman for her suggestions. all errors and omissions are my own. 2 e-media, or electronic media, is defined broadly to include any media that uses electronics (digital or analog) to reach end-users. this is in contrast to either print media or real life face-to-face interactions. e-media can include video, audio, multi-media, cell-phone, computer, or handheld devices. indiana health law review informed consent for treatment is a judicially created doctrine developed in the civil rights era. 3 the doctrine is premised on the concept that not only do individuals have a right to decide what happens to their bodies, but that individual goals, not simply medical goals, should drive treatment choices. to afford patients the information necessary to make these choices, healthcare professionals are given the responsibility (and legal duty) to provide education about medical treatment options. but the original model rests on a construct in which the healthcare professional (at the time, mostly physicians) retained significant control over medical information and resources. in fact, before the development of the doctrine of informed consent, not only were patients not involved in choosing a treatment, they often were not even told their diagnosis. there are debates about whether the original doctrine of informed consent weighed too heavily in favor of autonomy over beneficence. but it did so against a history in which patient played almost no role in medical decision making, and, thus, an effort to overcompensate is understandable. fast-forward half a century and our world looks very different. with the advent of e-medical diagnostic tools, direct-to-consumer advertisements, over-the-counter access to medications, and individually controlled genetic testing, the model of control has started to shift away from physicians. at the same time, we continue to push the concept of autonomous decision making into situations in which it may less easily function. new structures of healthcare delivery rely on fully informed patients making choices based on complex quality and cost data, with little understanding about the limitations of informed consent in this context. patients are regarded as consumers of healthcare, much as people are thought to be consumers of other goods and services. less attention is paid to whether information sharing and informed consent can live up to the goals we currently set for them. not only do we expect individuals to incorporate increasing amounts of complex information into their decisions (including information that 3 jessica w. berg et al., informed consent: legal theory and clinical practice (2d ed. 2001). vol. 11:2590 e-health revolution and informed consent is provided outside of the traditional patient-physician relationship), we see a growing effort to place individual responsibility on people for maintaining their health. in some cases we even blame patients for what are seen as poor choices, such as obesity. what role can and should informed consent play in the current system? should healthcare professionals still have the same disclosure obligations in the information overload of the internet world? how can the new technologies help facilitate information transfer, and how should the legal doctrine accommodate such changes? after providing a brief background on informed consent, this article explores the proliferation of e-health technologies and introduces some of their ethical and legal implications. it will focus on two areas: use of e-health 4 tools to supplement traditional informed consent practices, and the use of e-health technologies to replace traditional medical interactions. i. background a. informed consent5 a doctrine judicially created in the late 1960's and early 1970's, informed consent has become a standard part of medical practice. 6 it is an interesting question whether the judicial doctrine drove the ethical one or vice versa. prior to development of the judicial doctrine, consent played little or no role in standard medical practice. unlike, for example, the doctrine of confidentiality, which has a long history in medicine, informed consent does not show up in ethical 4 there are both provider and consumer e-health tools. this paper focuses on the latter, e.g., "a broad category of electronic tools and services that are primarily consumer oriented but that overlap with health information technology, a term more conventionally used in the context of technology for health care providers." lygeia ricciardi et al., a national plan to support consumer engagement via e-health, 32 health aff. 376, 384 (2013). 5 see generally jessica berg, all for one and one for all: informed consent and public health, 50 hous. l. rev. 1 (2012). 6 see jessica w. berg et al., supra note 3. 2014 591 indiana health law review codes until late in the twentieth century.7 regardless of its origins, informed consent now forms the bedrock of clinical bioethics. it is not, however, without its critics. while the principle of autonomy drives much of the bioethics discourse, many commentators have pointed out the need to balance autonomy against other interests and incorporate other ethical approaches besides the principalist one upon which the doctrine of informed consent appears to be based.8 autonomy is a western (and distinctly american) value and may not fit well within other cultures and practices.9 even under a principalist approach to bioethical issues in medicine,' 0 the principle of autonomy may sometimes be outweighed by the principle of justice, which can limit the distribution of scarce medical resources regardless of individual preferences," or the principle of autonomy may be outweighed by the principle of beneficence, which may weigh in favor of treatment even over the individual's objections. others have pointed out 7 id. informed consent for research developed separately from informed consent for medical practice, and its current structure is based on federal regulations. a full analysis of the development of the informed consent doctrine is beyond the scope of this piece. 8 id. at 32-35. principalism identifies the key principles which should drive ethical action (in medicine this is usually autonomy, beneficence, nonmaleficence and justice). see, e.g., tom l. beauchamp & james e.childress, principles of biomedical ethics (7th ed. 2012). informed consent developed from the promotion of the principle of autonomy (allowing individuals choice over what happens to them), as well as the principle of beneficence (individuals are deemed to be the best able to judge what in in their own interests and will be of the most benefit). 9 charles e. schneider, the practice of autonomy: patients, doctors, and medical decisions (1998). 10 see, e.g., tom l. beauchamp & james f. childress, principles of biomedical ethics (6th ed. 2009). a principalist approach identifies a series of core principle which should guide medical practice. according to the version proposed by beauchamp and childress, the principles include autonomy, nonmaleficence, beneficence, and justice. in many applications of the principalist approach the principle of autonomy seems paramount. 11 justice concerns (sometimes referred to as fairness or equality) may limit the distribution of scarce resources. in such cases we may limit the types of choices the individual can make to ensure a more just distribution across society. vol. 11:2592 e-health revolution and informed consent that even if autonomy is, or should be, a primary value in our society, there are limits to the extent to which we can expect patients to make fully autonomous decisions. individuals do not function in a vacuum and rarely make decisions without input and advice from various people (e.g., family, friends, and sometimes experts). moreover, the fact that someone may make a decision, even an important one, without fully considering all of the relevant information does not mean we should not give it respect and weight. part of being an autonomous individual is having the right to make decisions without full information. additionally, there is a growing psychological literature which indicates that decision making can be influenced in a variety of ways, including simply by the way in which certain information is disclosed. 12 i will return to this point later. informed consent, while often referred to as a unitary concept, is really made up of two requirements: a duty to disclose information and a right to make decisions. to meet the information requirement, physicians must disclose basic information about the patient's diagnosis and treatment options along with their risks, benefits, and alternatives. the patient is asked to either consent to or refuse the treatment (in this sense, "informed choice" may be a better name for the doctrine than "informed consent" since refusals must also be informed).13 the established exceptions include incompetence,14 waiver,15 emergencies, therapeutic privilege, and some public health 6 interventions. the vast literature and extensive case law on informed consent will not be rehashed here.' 7 12 see, e.g., daniel kahneman, thinking, fast and slow (2011). 13 berg et al., supra note 6. 14 see jessica w. berg et al., constructing competence: formulating standards of legal competence to make medical decisions, 48 rutgers l. rev. 345 (1996). 15 jessica w. berg, understanding waiver, 40 hous. l. rev. 281 (2003). 16 berg, supra note 3. 17 id. 2014 593 indiana health law review why require individual informed consent? consent theorists offer a number of reasons.18 first, individuals are most likely to know their interests and thus make better choices for their health and well-being. second, the information requirement may increase the likelihood that the intervention will be beneficial since the individual better understands what to expect, including being prepared to recognize problems that may arise. third, even if individuals err in their choices, we are better off as a society if we encourage individual decision making and, thus, develop autonomous citizens. fourth, individuals have a right to control what happens to their bodies. b. rise of e-health in fact, it is this focus on individual control over self and the benefits which may flow from promoting autonomy that have prompted many of the technological advances in consumer e-health. various studies over the past decade have focused on developing mechanisms to facilitate patient engagement in their medical care to achieve better health outcomes.19 the 2001 institute of medicine report "crossing the quality chasm: a new health system for the 21st century," emphasized that information technology ("it") should play a significant role in achieving this goal.20 the report noted that, among other things, it can do the following: * facilitate access to more understandable clinical knowledge; * afford more timely information sharing through internet based communication tools; 18 berg et al., supra note 7, at 18; see also faden & beauchamp, a history and theory of informed consent 7-16 (1986) (including also the principle of justice, but noting that "[t]he major moral and conceptual problems about informed consent are not justice-based and do not directly confront issues of social justice"). 19 see studies cited in ricciardi, supra note 3 at 377. 20 inst. of med., comm. on quality of health in am., crossing the quality chasm: a new health system for the 21st century 4164 (2001). vol. 11:2594 e-health revolution and informed consent * improve efficiency by coordinating information in one place and avoiding redundancies; and * enhance equity by allowing for multiple options for clinical interactions. 21 research exploring the benefits of e-heath determined that "[pleople who use e-health resources feel better prepared for clinical encounters, ask more relevant questions, know more about their health care, and are more likely to take steps to improve their health, compared to those who do not."2 2 as more people use e-health tools there should be a greater effect on the system. according to current estimates, "80 percent of us internet users have searched for health information online... 34 percent of internet users have read about other people's health and medical experiences online, and 18 percent of internet users have gone online to find others who share their health condition or concern."23 ii. the consumer e-health universe the e-health universe is extensive and a full analysis of all of the new technologies is beyond the scope of this article. for our purposes, there are two primary developments of interest. the first is the use of e-health technology to promote the shared decision making model, as a supplement to traditional informed consent. the second is the use of e-health technology as a substitute for clinical encounters. the following sections will address each of these in turn. a. e-health and shared decision making 21 id. at 164-165. 22 id. (footnotes omitted). 23 lygeia ricciardi et al., a national action plan to support consumer engagement via e-health, 32 health aff. 376, 378 (footnotes omitted). the authors also posit that the limits of e-health use are based not on lack of interest, but lack of access to the internet and that the appeal of e-health crosses a wide array of age, gender, and diversity lines. id. at 377. 2014 595 indiana health law review while the idea of shared decision making in informed consent is not new, 24 the development of the "shared decision making" ("sdm") model is more recent. 25 the model is premised on the assertion that the "emphasis on patient autonomy in medical-decision making can go too far"26 and that 'idlemonstrating respect for patient autonomy does not require physician to remain neutral sources of information in the care of their patients."27 rather than have the physician provide all information and the patient make a decision without input, a better approach would be to emphasize the shared aspects of decision making. as a result, the sdm approach involves a process of communication in which the physician and patient both evaluate together the patient's medical goals, life preferences, and risks/benefits of all viable treatment alternatives. 28 some commentators have noted that the sdm terminology can encompass a wide variety of concepts and fall under a range of labels; "[flor instance, its features have been referred to as informed decision-making, informed shared decision-making, partnership, patient involvement, patient-centered care, and evidence-based patient choice."29 24 see, e.g., president's comm'n, president's comm'n for the study of ethical problems in med. and biomedical and behavioral research, making health care decisions: the ethical and legal implications of informed consent in the patient-practitioner relationship (1982), available at https://bioethicsarchive.georgetown.edu/pcbe/reports/past-commissions/mak ing-healthcaredecisions.pdf ("[tihe commission sees 'informed consent' as an ethical obligation that involves a process of shared decision making based upon the mutual respect and participation of patients and health professionals. . . . ethically valid consent is a process of shared decision making based upon ritual to be equated with reciting the mutual respect and participation."), archived at http://perma.cc/a6vl-52vk. 25 benjamin moulton & jaime s. king, ahgning ethics with medical decision -making. the quest for informed patient choice, 38 j. l. med. & ethics 85 (2010). 26 id. at 88. 27 id. at 89. 28 id. 29 nora moumjid et al., shared decision-making in the medical encounter: are we talking about the same thing, 27 med. decision making 539 (2007) ("likewise, the term shared decision-making has vol. 11:2596 e-health revolution and informed consent a key to the implementation of sdm involves the use of decision support tools (in some cases multiple tools) to supplement the conversations between physician and patients. the "patient decision aids" are supposed to be standardized, evidence-based tools. 30 while they may take a variety of forms, including print, audio, or video media, there is a current shift toward internet-based technology. 31 although the goal of the sdm tools is to supplement the clinical informed consent process, "[m]any, if not most, patient decision support interventions have designs that make it possible for patients to use them independently of the clinical encounter because they contain comprehensive information and guidance." 32 nonetheless, they are not intended to be freestanding tools; their focus, instead, is on helping the patient identify his or her preferences, goals, and questions prior to the informed consent dialogue with the healthcare provider.33 the sdm model raises various issues for the legal doctrine of informed consent but does not necessarily challenge the underlying framework. others have addressed these issues in detail and their work will not be repeated here. nadia sawicki explores the tort law been used to mean many different things, such as a process requiring mutual agreement between patient and physician or a method of providing information to the patient and then leaving the patient to make her own decision."). 30 annette m. o'connor et al., modifing unwarranted variations in health care: shared decision making using patient decision aids, 23 health aff. var-63, var 64 (2004). 31 id. the most useful models incorporate a number of different tools. for example, the dartmouth sdm model uses (1) a video decision aid, (2) an online survey and written questionnaire, (3) optional additional resources for resolving conflict, (4) a sdm communication process, and (5) a post-treatment survey. see moulton & king, supra note 25, at 91 (describing the model). 32 glen elwyn et al., investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions, 30 med. decision making 701, 702 (2010). 33 thaddeus mason pope & melinda hexum, legal briefing: shared decision making and patient decision aids, 24 j. clinical ethics 70, 71 (2013). 2014 597 indiana health law review implications of sdm in her 2012 articles,34 and others, such as thaddeus pope and melinda hexum, have followed up with a discussion of a range of other legal issues raised by the use of sdm tools. 3 5 they conclude that we must do a better job at assuring quality in this context by developing clear standards and certification mechanisms for the tools, address how provider reimbursement will work when using the tools, and expand research regarding the effectiveness of the tools. there are also some interesting questions about how courts will respond to the use of the tools in altering traditional informed consent liability. for example, washington state enacted legislation in 2007 making the use of a sdm tool prima facie evidence of legally valid informed consent. while a traditional signed informed consent form likewise constitutes prima facie evidence, the sdm tool creates a heavier burden of rebuttal for any patient seeking to challenge informed consent as inadequate. thus a patient would have to show negligence by clear and convincing evidence that consent was not informed, instead of the usual preponderance of the evidence.36 washington also recently enacted legislation encouraging the use of sdm aids and proposed a process for certifying decision aids.37 other states have passed or are considering similar laws. 38 building upon the initial efforts to create sdm tools, some companies have been developing fully online consent systems. emmi solutions, a healthcare communication company, developed an interactive e-consent program called emmi engage deliverable over the web and via mobile devices. 39 dialog medical has its imedconsent, 40 which was 34 see nadia n. sawicki, informed consent beyond the physicianpatient encounter: tort law implications of extra-clinical decision support tools, 21 annals health l. 1, 3(2012); nadia n. sawicki, patient protection and decision -aid qualityregulatory and tort law approaches, 54 ariz. l. rev. 621, 630 (2012). 35 pope & hexum, supra note 33. 36 wash rev. code §§ 7.70.060, 41.05.033 (2014). 3 wash. rev. code § 7.70.060 (2014). 38 see pope & hexum, supra note 33, at 73. 39 our proven solutions drive outcomes central to your business, emmi solutions, http://www.emmisolutions.com/index.php/ourvol. 11:2598 e-health revolution and informed consent adopted by the va healthcare system in 2004.41 initial data from a study of the imedconsent showed positive effects in terms of both patient comprehension and patient engagement. 42 pushing the forefront of e-health tools, researchers at case western reserve university are developing the esmartt application, which uses digital avatars to help individuals make healthcare decisions. 43 efforts are also underway in the research informed consent setting. the perelman school of medicine at the university of pennsylvania initially developed an online informed consent tool, oncolink, to help cancer patients to understand and feel comfortable enrolling in clinical trials and later expanded it to proton therapy trials. 44 other companies are seeking to completely digitize the informed consent process. for example, mytrus created a new ipad econsent application designed for clinical trials.45 similarly, solutions (last visited may 14, 2014), archived at http://perma.cc/x7au2num. 40 imedconsent informed consent solution, dialogue med., http://www.dialogmedical.comlwp-content/uploads/2011/08/productmatrix_ sheet-hostedandenterprisel.pdf, archived at http://perma.cc/d2gzafbz. 41 michael j. kussman, veterans health admin., dep't veterans aff., vha handbook 1004.05: imedconsent (2009), available at http://www.va.gov/vhapublicationsniewpublication.asp? pubid=1857, archived at http://perma.cc/v7a4-nwvs. 42 daniel e. hall et al., the impact of imedconsent on patient decision -making regarding cholecystectomy and inguinal herniorrhaphy, 175 j. surgical res. 227, 231 (2012). 43 susan griffith, new technology to guide people through healthcare decisions, think (august 8, 2013, 12:14 pm), http://blog.case.edulthink/2013/08/08/new-technologyto-guide-people_t hrough-healthcaredecisions, archived at http://perma.ce/pf7z-eyue. 44 penn-developed online informed consent tool could boost number of patients in cancer clinical trials, penn med. (oct. 3, 2011), http://www.uphs.upenn.edu/news/newsreleases/2011/10/astro-consenttool/, archived at http://perma.cclv4qk-xfym; b. e. rosenbaum et al., an internet-based, multimedia informed consent resource for proton therapy clinical trials: a pilot study, 81 int'l j. radiation oncology, biology, physics s572 (2011) available at http://astro2011.abstractsnet.com/pdfs/2754.pdf, archived at http://perma.cc/bx5l-qp7b. 45 anthony costello, mytrus, mytrus rolls out clinical research industry's first patient-friendly system for informed consent via ipad@ 2014 599 indiana health law review consent solutions has an interactive e-consent tool,46 as does systemedicus. the latter's educonsent is an interactive clinical trial e-consent ipad system which not only provides information, but it also records the consent process and includes facial recognition and signature capture technology to authenticate documentation. 4 7 these new tools are all built upon the current informed consent framework (albeit some with the tweaks of the sdm approach) and raise few questions beyond the ones addressed above. key concerns remain: assuring quality, facilitating access, and ensuring that the tools are developed using empirical evidence regarding what approaches facilitate understanding and informed consent. this latter point is further complicated by the rise of ehealth substitutes for clinical encounters, discussed below. b. e-health substitutes for clinical encounters perhaps more interesting than the use of supplemental decision making tools is the development of e-health substitutes for traditional clinical encounters. interest in "medical apps" (a term that appeared around 2007) has increased enormously over the past few years.48 the market research company research2guidance claims that 247 million mobile phone users downloaded a health related app in 2012,49 and as of march 2013, more than 97,000 application, market wired (apr. 9, 2012, 8:00 am), http://www.marketwire.com/press-release/mytrus-rolls-out-clinical-researchindustrys-first-patient-friendly-system-informed-1641376.htm, archived at http://perma.cc/69fu-f69x. 46 ann neuer, informed consent goes digital, uthealth (aug. 29, 2013), http://www.clinicalinformaticsnews.com/ ecliniquaarticle.aspx?id=129295, archived at http://perma.cc/g46mctjn. 47 see systemedicustm, http://www.systemedicus.com/ (last visited apr. 14, 2014), archived athttp://perma.cc/v2tn-9tlc. 48 bill yates, google trends: data highhghts medical and healthcare app growth, imedicalapps (aug. 14, 2013), http://www.imedicalapps.com/ 2013/08/google-trends-medical-healthcare-app/, archived at http:l perma.cc/9cr5-y28v. 49 ralf-gordon jahns, us$ 1.3 billion: the market for mhealth applications in 2012, research2guidance (jan. 25, 2012), 600 vol. 11:2 e-health revolution and informed consent mobile health applications were listed in 62 app stores.50 apple's app store, for example, lists 13,000 health apps.51 apple has even launched an "apps for healthcare professionals" collection within its app store's medical category which covers different sectors like nursing, monitoring, imaging and patient education. some apps provide basic information for healthcare professionals; others provide resources for patients (including mechanisms to keep track of illness, or provide support for care). reserach2guidance projects that the market for mobile healthcare apps services will reach $26 billion globally by 2017.52 the technology market research firm abi research estimates that the global market could reach 170 million devices by 2017.53 a recent survey from the health communications firm digitas health indicates that "[a] staggering 90 percent of chronic patients in the us would accept a mobile app prescription from their physician, as opposed to only 66 http://www.research2guidance.com/us1-3-billion-the-market-for-mhealthapplications-in-2012/, archived at http://perma.cc/9gpb-8zyp. 50 research2guidance, mobile health market report 2013-2017 3 com. mhealth applications 1, 7 (2013), available at http://www.research2 guidance.com/shop/index.php/downloadable/download/sample/sample-id/26 2/, archived at http://perma.c/83fr-5vwl; see also peter mclaughlin & melissa crespo, the roliferation of mobile, devides and apps for health care: promises and risks, bloomberg bna (may 21,2013), http://about.bloomberglaw.com/practitioner-contributions/the-proliferationof-mobile-devices-and-apps-for-health-care-promises-and-risks/, archived at http://perma.cc/7unn-ttpu. 51 app store>medical, itunes preview, https://itunes.apple.com/ us/genre/ios-medical/id6020?mt=8&letter=h (last visited apr. 14, 2014), archived at http://perma.cc/h6gv-ee2c. 52 ralf-gordon jahns, the market for mhealth app service will reach $26 billion by 2017, research2guidance (mar. 7, 2013), http://www.research2guidance.com/the-market-for-mhealth-app-serviceswill-reach-26-bilhion-by-2017/. 53 stephanie tilenius, will an app a day keep the doctor a way? the coming health revolution, forbes (sept. 8, 2013, 8:30 am), http://www.forbes.com/sites/ciocentral/2013/09/08/will-an-app-a-day-keepthe-doctor-away-the-coming-health-revolution/; see also travis lee street, is healthcare the future of mobile apps$ biobeats (aug. 19, 2013), http://biobeats.com/2013/08/19/is-healthcare-the-future-of-mobile-apps/. 2014 601 indiana health law review percent willing to accept a prescription for medication." 54 happtique, a subsidiary of the business arm of the greater new york hospital association, is working on a system to allow doctors to prescribe apps, which would then be "filled" at app stores by patients.5 5 government officials in the united kingdom recently announced that doctors will be encouraged to prescribe smartphone apps to help patients manage conditions ranging from diabetes to depression.5 6 these new mobile apps range from data gathering, to information sharing (between patient and healthcare provider), to actually providing care. one of the pioneers in the prescription-app field is a company called welldoc. welldoc has a diabetesmanager system, which "patients can use through a smartphone app, standard cellphone or desktop computer . . . [to collect] information about a patient's diet, blood sugar levels and medication regimen. patients can enter this data manually or link their devices wirelessly with glucose monitors."5 7 this app was one of only a handful of apps that gained clearance from the fda through their 510k device clearance process.5 8 in june 2013, at the second annual digital health summer summit, welldoc announced the upcoming launch of bluestar, the first fda-cleared prescription-only smartphone app for type 2 diabetes with insurance reimbursement.5 9 54 jonah comstock, most patients want their doctors to prescribe apps, mobihealthnews (july 1, 2013), http://mobihealthnews.com/ 23418/most-patients-want-their-doctors-to-prescribe-apps/, archived at http://perma.cc/hx7-dt5b. 55 joshua brustein, coming next-7 using an app as prescribed, n.y. times (aug. 19, 2012), http://www.nytimes.com/2012/08/20/technology/ coming-next-doctors-prescribing-apps-to-patients.html?pagewanted=all&_ r=1&, archivedathttp://perma.cc/ f94c-zzd4. 56 murray wardrop, doctors told to prescribe smartphone apps to patients, the telegraph (feb. 22, 2012, 8:29 am), http://www.telegraph.co. uk/healthlhealthnews/9097647/doctors-told-to-prescribe-smartphone-appsto-patients.html, archivedathttp://perma.cc/xak5-h2by. 57 id. 58 id. 59 weildoc launches bluestar, first fda-cleared, mobile prescription therapy for type 2 diabetes with insurance reimbursement, businesswire (june 13, 2013, 9:00 am), http://www.businesswire.com/ news/home/20130613005377/en/weildoc-launches-bluestar-fda-cleared602 vol. 11:2 e-health revolution and informed consent according to its website, "bluestar is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. . . . in addition, bluestar provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends."60 a few major national employers-including ford motor company, rite aid, and dexcom-have already agreed to reimburse employees who use the app through prescription benefit plans. patients will take the physician's prescription to a pharmacist, who adjudicates the claim and notifies welldoc. welldoc then dispatches a staffer to meet with the patient, install the app, and offer training.61 in another example of efforts in this area, the veteran affairs administration's national center for posttraumatic stress disorder has been in collaboration with the national center for telehealth and technology ("nctt") to develop a new genre of mobile apps to assist veterans and active duty personnel (and civilians) who are experiencing symptoms of post-traumatic stress disorder ("ptsd") and traumatic brain injury.62 according to nctt's website, the key features of the ptsd app include: * self-assessment: self-assessment of ptsd symptoms with individualized feedback, and ability to track changes in symptoms over time. the assessment does not formally diagnose ptsd. * system management: coping skills and mobile-prescription-therapy, archived at http://perma.cc/b2n59n9g?type-image. 60 faqs, welldoc, http://www.bluestardiabetes.com/ ?pageid=347 (last visited apr. 19, 2014). 61 mohana ravindranath, weildoc to release prescriotion-only smartphone app, the wash. post (june 23, 2013), http://articles.washingtonpost.com/2013-06-23/business/ 40152258_1appglucose-welldoc, archived at http://perma.ccld3em-xlsl. 62 new mobile app helps troops to self-manage behavior, stress, nat'l ctr. for telehealth and technology, https://t2health.org/ news/new-mobile-app-helps-troops-self-manage-behavior-stress (last visited apr. 14, 2014), archivedathttp://perma.ce/6czp-x3ke. 2014 603 indiana health law review assistance for common kinds of posttraumatic stress symptoms and problems, including systematic relaxation and self-help techniques. * support: assistance in finding immediate support. the app enables individuals to identify personal sources of emotional support, populate the phone with those phone numbers, and link to treatment programs. and in an emergency, users can quickly link to the national suicide prevention hotline. * ptsd education: education about key topics related to trauma, ptsd, and treatment.63 ptsd coach mobile application has been downloaded 45,000 times in fifty-eight countries, with high consumer satisfaction (according to the ratings in the app store-ios: 5/5; android: 4.5/5). it was awarded the federal communication commission chairman's 2011 aaa award, the 2012 american telemedicine association annual awards, and named the best federal government app according to nextgov.com. 64 more than three-quarters of patients found ptsd coach enhanced their understanding of ptsd and its symptoms; helped them find ways to manage those symptoms; made them feel more comfortable seeking support; enabled them to feel they can do something; and allowed them to track problems, find additional resources, and provided practical solutions to problems.65 63 ptsd coach, nat'l ctr. for telehealth and technology, https://t2health.org/apps/ptsd-coach (last visited may 14, 2014), archived at http://perma.cc/5a2s-q2s8. 64 ata president's awards recipients, am. telemedicine ass'n, http://www.americantelemed.org/about-ata/ata-leadership/ ata-awards-recipients (last visited apr. 19, 2014), archived at http://perma.cc/7wkd-bvqd. 65 ptsd coach mobile app wins the ata presidents award for innovation, nat'l ctr. for telehealth and technology, https://t2health.org/news/ptsd-coach-mobile-app-wins-ata-presidents-awardinnovation (last visited may 14, 2014), ambived at http://perma.cc/be99yas. 604 vol. 11:2 e-health revolution and informed consent despite the promise of these apps, they are mostly developed without oversight. the fda recently announced it would regulate only those apps which either are used as an accessory to a regulated medical device or that transform a mobile device into a "regulated device" by sending medical information to care providers. 66 while the agency was adamant that it would not regulate cell phones and tablets that use the apps, the line between apps and medical devices is becoming less clear. 67 iii. implications of the new e-media for informed consent there are a number of issues raised by the increasing use of e-health technologies in both the sdm context and the new treatment apps. development of both areas rests, in part, on similar underlying constructs of autonomy in which the patient need only be provided with enough information (albeit perhaps in better or more 66 mobile medical applications, food and drug admin., http://www.fda.gov/medicaldevices/productsandmedicalprocedures/conne ctedhealth/mobilemedicalapplications/default.htm (last updated oct. 22, 2013), archived at http://perma.cclm9gd-s63z. 67 letter from fred upton et al., subcommittee on oversight and investigation, to margaret hamburg, commissioner, u.s. food and drug administration (mar. 1, 2013), available at http://energycommerce.house.gov/sites/republicans.energycommerce.hou se.gov/files/letters/20130301fda.pdf, archived at http://perma.cc/p8zatrbt. besides welldoc's app, the following devices have fda approval: alivecor, which snaps onto the back of a smartphone and turns the device into an ekg and takes cardiac measurements when the user presses the device against the skin near the heart, was classified as a class ii device and issued 510(k) clearancel2 in november 2012 by the fda; welch allyn, iexaminer adapter; and ophthalmoscope, an app and ophthalmoscope that plugs into a smartphone and can detect conditions like retinal detachment and glaucoma, while the accompanying examiner app allows health providers to store the pictures to a patient file or print or email them, received 510(k) clearance for the app in december 2012. december 2012 510(k) clearances, food and drug admin., http://www.fda.gov/medicaldevices/productsandmedicalprocedures/devi ceapprovalsandclearances/5l0kclearances/ucm334768.htm (last updated mar. 12, 2014), archived at http://perma.cc/495m-n3cl. 2014 605 indiana health law review understandable formats) in order to make a decision. while the sdm model shifts slightly away from the idea of the patient as a unitary decision maker, it still accepts the basic tenet that autonomous choice is possible as long as information is plentiful. various studies of traditional informed consent over the years challenge this assumption. individuals have great difficulty understanding some of the complex information shared in these areas. for example, peter schwartz recognizes that "the existence of 'heuristics' and 'biases' in human thought [ hinder the rational processing of quantitative information" on the risks and benefits of a medical intervention.6 8 for example, the majority of the population in the united states (and elsewhere) cannot understand probabilities and frequencies. 69 most people use cognitive shortcuts to analyze statistical information, such as giving undue weight to examples they can call to mind most easily (consider the larger fear of airline crashes than car crashes, despite a greater statistical likelihood of the latter). there are biases such as "anchoring and adjustment" (allowing a previous incorrect overestimation of a risk to determine its importance in later decisions), "optimism bias" (assuming you will be the one lucky person when given a description of odds), and "denominator neglect" (failing to consider the overall population when focusing on a serious risk that affects a very small number of people in the group).70 decision aids that provide such quantitative information may be as likely to cause confusion for a decision maker as face-to-face interactions, which also convey such information. as a result, schwartz argues that we ought to consider how we incorporate quantitative information into decision aids and consider carefully the algorithms that determine which quantitative information patients want.7 1 similarly, initial research regarding 68 peter schwartz, questioning the quantitative imperative: decision aids, prevention, and the ethics of disclosure, 41 hastings ctr. rep. 30 (2011). 6 id. at 34. 70 id. at 35. 71 id. at 36. vol. 11:2606 e-health revolution and informed consent "nudging"-also known as "choice architecture"-and informed consent highlights the effect of small differences in the presentation of information (even the order in which something is discussed) on the patient's eventual choice.72 these challenges to the traditional model of informed consent raise similar concerns for the use of new technologies as both supplements and substitutes for informed consent. these tools raised additional concerns since the provision of information via e-media may further obfuscate the nuances of information disclosure and potentially increase the effect of any biases. at the very least, more data is needed on the ways in which these tools might influence decision making. for example, do patients give more weight to information provided through these tools? others have pointed out that the evidence supporting the use of decision making tools does not necessarily "support its potential to reduce overtreatment and costs" in part because of "inadequate consideration of the complexity of how patients construct and express their preferences for treatment."73 likewise, we do not know whether these tools actually help achieve better informed consent since we lack measurements to determine what actually constitutes better or worse informed consent processes. more information is not always better, nor does it necessarily increase freedom of choice. furthermore, to the extent that we do have theories that might drive the goals of informed consent, it is not clear that these theories are driving the development of the e-health tools (this may be less true of some of the new comprehensive e-consent frameworks). moreover, setting standards to achieve quality control is crucial, but without a structure for understanding what measurements of quality to apply it is an almost impossible task. what information to provide and in what format are still key questions for informed consent and we need more 72 see generally shlomo cohen, nudging and informed consent, 13 am. j. bioethics 3 (2013) and accompanying peer commentaries. 73 steven katz & sarah hawley, the value of sharing treatment decision making with patients: expecting too much, 310 jama 1559 (2013). 2014 607 indiana health law review specific answers than the general approach of "all information" provided in an "understandable format." paradoxically, gathering data about the specific uses of the new tools and the implications for patient choice raise additional ethical concerns. there is little evidence regarding the type and extent of data collection that happens behind the scenes in health apps. many companies may view the data they gather as a proprietary resource, to be used for the further development of e-media tools. few people provide fully informed consent to the use of their information garnered from apps, medical ones included. whether or not we should be concerned about the lack of individual consent and control in this area may depend on whether we think the information is used appropriately, and whether we see this data as entitled to protections similar to those given to other types of medical information. iv. conclusion the use of e-health technologies is likely to increase exponentially as more tools are developed. they will continue to play an important role both in supplementing and supplanting clinical encounters. there are significant benefits derived from their adoption, and my goal is not to limit innovation. nonetheless, it will be important to consider some of the concerns raised by the use of these tools in different contexts and to develop ways to address those concerns in order to prevent later problems. overall, informed consent will continue to play an important role in healthcare, despite the varying sources of information, but expectations regarding the benefits of the doctrine should be subject to realistic constraints and informed by empirical data about the limits of autonomous medical decision making. technology moves forward quickly; ethics and evaluation move at a slower pace. it behooves us to work hard to catch up in this context. vol. 11:2608 indiana health law review heather harrell heather harrell received her ba from columbia college of columbia uni­ versity and her md from baylor college of medicine. she completed a fellowship in bioethics at the university of louisville's institute for bioeth­ ics, health policy and law before obtaining her jd from northwestern university. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i direct-to-consumer advertising of prescription pharmaceuticals, the learned intermediary doctrine, and fiduciary duties heather harrell* i. introduction ................................................................................. 71 ii. background on tile lid .............................................................. 75 ill. dtc advertising warrants a general or case-by -case exception to the lid, especially given recent changes to the health care system ........................................................ 78 iv. drug promotion to the physician provides further support for a general or case-by -case exception to tiie lid ............................................................................................ 84 v. dtc advertising creates a near or actual fiduciary relationship between patient and pharmaceutical manufacturer .............................................................................. 87 vi. conclusion .................................................................................... 92 l. introduction advertisements for prescription medications have become ubiquitous. 1 it is nearly impossible to watch thirty minutes of television without seeing at least one, if not several, advertisements for medications treating such conditions as erectile dysfunction, insomnia, high cholesterol, or overactive bladder. pharmaceutical manufacturers rely on more than just television to spread the word about their products; manufacturers also rely on magazines, newspapers, and interactive websites. the seeming bombardment of the public by promotion of prescription pharmaceuticals is truly a barrage on the public by the pharmaceutical in­ dustry as evidenced by the amount spent on drug advertising. in 2005, spending on direct-to-consumer ("dtc") advertising was over $4.23 bil­ lion,2 and total spending on drug promotion was approximately $29.9 bil­ lion.3 advertising, both directly to the patient as well as to the physician, * ba, columbia college, columbia university, 1999. md, baylor college of med­ icine, 2004. jd, northwestern university school of law, 2008. i would like to thank all of those who read and commented on this article, especially mark rothstein. sincere thanks to my family for their continued support. 1. andrew r. robinson, et al., direct-to-consumer pharmaceutical advertising: physician and public opinion and potential effects on the physician-patient relationship, 164 archives internal med. 427, 431 (2004) (noting that 99.2% of the public reported seeing at least one dtc advertisement). 2. julie m. donahue, marisa cevasco & meredith b. rosenthal, a decade of direct­ to-consumer advertising of prescription drugs, 357 new eng. j. med. 673, 676 (2007). 3. /d. at 676. the percentage of sales spent on drug promotion has increased from 72 indiana health law review [vol. 8:69 works one review found that for each dollar spent on promotion, pre­ scription sales increased $2.20.4 these figures raise concerns that this in­ crease in prescription drug sales may represent overuse of these drugs or overuse of the more expensive, advertised drug in lieu of a cheaper, equally effective altemative.5 though the amount spent on drug promotion may be concerning in and of itself, the content of some dtc advertisements raises further issues. many advertisements, for all practical purposes, recommend the medication for those individuals with certain symptoms. some companies have set up on-line quizzes to assess the need for a particular medication, 6 with the pharmaceutical manufacturer usually giving feedback on the quiz to the prospective patient. 7 although these individuals are instructed to share the quiz results with their physicians, 8 the results and, sometimes, physician­ directed information about the results, are available to the potential con­ sumer of the drug.9 in addition to interactive and advisory internet advertis­ ing, individuals can download free trial coupons for prescription medications10 or apply for financial assistance from the drug company for their prescriptions.11 in other words, advertisements may do more .than mention a drug and its indications; advertisements are offering incentives and advice that may be based on individualized information. such adver­ tisements are likely to influence prescription-seeking behavior and should not be legally unchecked. advertising of prescription pharmaceuticals is regulated by the food and drug administration ("fda"). changes to fda regulations in 1997, allowed for the burgeoning of dtc advertising.12 concomitant with the increase in dtc advertising, there has been a decrease in the number of fda letters sent to pharmaceutical manufacturers regarding violations of the dtc advertising regulations.13 while some have interpreted these facts to demonstrate increased compliance with the regulations, 14 others feel the fda is overwhelmed and has insufficient manpower and systems in place 14.2to 18.2%between 1996and2005. id at675. 4. u.s. gov't accountability office, ga0-07-54, prescription drugs: improvements needed in fda's oversight of direct-to-consumer advertising (2006) [hereinafter ga0-07-541 available at http://www.gao.gov/new.items/d0754.pdf. 5. donahue et al., supra note 2, at 674. 6. see, e.g., oab symptom quiz, pfizer inc. (dec. 29, 2009), http:l/www.detrolla .com/oabsymptomquiz.aspx?printerfriendly=true. 7. see, e.g., id. 8. see, e.g., id 9. see, e.g., id 10. see, e.g., special toviaz offers, pfizer, inc. (nov. 4, 2010), http://www.toviaz .com/offers.aspx. 1 i. see, e.g., id. 12. see, e.g., donahue et al., supra note 2, at 674; daniel richardson. the lost child of products liability: new thoughts about advertising and the learned intermediary doc­ trine, 27 vt. l.rev. 1017, 1033 (2003). 13. ga0-07-54, supra note 4, at 21. 14. donahue et al., supra note 2, at 679. 2011] direct-to-consumer advertising of pharmaceuticals 73 to provide proper oversight.1s in support of the latter contention, the united states government accountability office found significant limitations to fda regulation ofdtc advertising in two separate reports.16 these regula­ tory limitations, however, do not leave the consumer without recourse. the tort system indirectly and retrospectively supplements fda regu­ lation of dtc advertising by providing relief to those who have been in­ jured. by an advertised drug. 17 under product liabilities law, the main claims that can be pursued by injured individuals are manufacturing defect, design defect, or failure to warn.18 however, only failure to warn claims relate to dtc advertising and these claims are effectively barred in many jurisdictions by the learned intermediary doctrine ("lid").19 the lid es­ sentially states that, because a patient must receive a prescription from a physician, the manufacturer of prescription medication has fulfilled its duty to warn by warning the physician. 20 in other words, the physician remains liable to the patient for failing to share the medication's risks, but the phar­ maceutical manufacturer does not. 21 hence, the tort system is, in many ju­ risdictions, limited in its ability to supplement the fda's regulation ofdtc advertising. exceptions to the lid do exist and are usually applied when circum­ stances have changed the patient-physician relationship. an exception has been applied for dtc advertising in some jurisdictions.22 when an excep­ tion to the lid is applicable, the manufacturer of the prescription drug is responsible for warning the ultimate consumer. this article examines some recent data about the effects of dtc ad­ vertising on the patient-physician relationship in support of the notion that dtc advertising warrants an exception to the lid. prescription drugs are also promoted to physicians. hence, drug advertising encroaches upon the fiduciary patient-physician relationship not from one, but from two sides. not only should the law protect the patient-physician relationship by dis15. see, e.g., id.; ga0-07-54, supra note 4, at 19 (mentioning that the fda does not have the manpower to review all of the advertisements it receives). 16. see gad-07-54, supra note 4; u.s. gov't ac(:ounting office, ga0-03-177, presclupnon drugs: fda oversight of dlrect-to-consumer advertising has limitations (2002), available at http://www.gao.gov/new.items/d03177 .pdf. 17. see generally restatement (third) of torts: products liability § 6 ( 1998). 18. /d. 19. larkin v. pfizer, inc., 153 s.w.3d 758, 767 (ky. 2004) (finding thirty-four states had officially adopted the lid); vitanza v. upjohn, 778 a2d 829, 838 (conn. 2001) (find­ ing forty-four jurisdictions had adopted the lid). 20. see, e.g., vitanza, 778 a2d at 832. 21. however, it is important to note that the manufacturer could be held liable even in jurisdictions where the lid is applied if it is found that the drug maker inadequately warned the physician. ackerman v. wyeth pharm., 526 f.3d 203, 208 (5th cir. 2008). 22. see, e.g., perez v. wyeth lab. inc., 734 a.2d 1245, 1247 (n.j. 1999) (stating that "a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product.j. 74 indiana heal til law review [vol. 8:69 couraging such intrusion into a fiduciary relationship; but drug promotion raises the question of whether a physician can function as a true "learned intermediary" in such an environment. this article outlines the criteria for a true "learned intermediary'' as can be deduced from the case law. this article also suggests that the question of whether a physician fulfilled the criteria that justifies application of the lid be considered on a case-by-case basis. research is used to demonstrate how drug promotion makes it diffi­ cult, if not impossible, for the physician to function as a true "learned in­ termediary." in other words, this article argues that a general exception to the lid is justified: 1) by traditional considerations given recent research on the effect of dtc advertising on patient-physician relationships; 2) be­ cause dtc advertising makes it difficult for a physician to fulfill the crite­ ria of a "learned intermediary;" and 3) because the law should protect fiduciary relationships, especially when that relationship is weakened by influence exerted over both doctors and their patients. if a general excep­ tion for dtc is not accepted or not deemed applicable, courts should con­ sider in each case whether the physician met the criteria of a true "learned intermediary." this article further argues that the content of pharmaceutical adver­ tisements and websites has placed prescription drug manufacturers, at least some of the time, in a near or actual fiduciary role with respect to the ulti­ mate consumer of their prescription medications. given the responsibility that comes with being a fiduciary, it is untenable to insulate the drug maker through the lid from liability for their advertisements. by opening up lia­ bility through the elimination of the lid when dtc advertising has oc­ curred or, at the very least, considering whether the physician functioned as a true "learned intermediary'' in cases where an· exception to the lid is not applied, products liability claims may successfully supplement fda regula­ tion of dtc advertising. section ii of this article provides background information on the lid and describes the characteristics of a "learned intermediary" as can be drawn from the case law. in section iii, this article argues that the rationale for exceptions to the lid is applicable when dtc advertising has occurred and the reasoning may be even more poignant given certain recent changes to our health care system. section iii also demonstrates how dtc impedes a physician's ability to serve as a true "learned intermediary''. section iv discusses how a legally recognized fiduciary relationship, the doctor-patient relationship, is weakened by both dtc and direct-to-physician advertising. this two-sided invasion of a fiduciary relationship provides additional sup­ port for creating an exception to the lid for dtc advertising. this section additionally demonstrates how direct-to-physician advertising may make it impossible for a physician to function as a true "learned intermediary." section v demonstrates how pharmaceutical manufacturers, through the content of their advertisements, place themselves in a near or actual fiduci­ ary role with respect to the ultimate consumer of their drugs. the final sec2011] direct-to-consumer advertising of pharmaceuticals 75 tion concludes with possible solutions to the current state of the lid. ii. background on 1he lid the tort system, mostly through failure to warn claims, provides some retrospective regulation of dtc marketing. comment k of the restatement (second) of torts addj:esses the need to provide "proper warning" for una­ voidably unsafe products, such as prescription pharmaceuticals. 23 while some courts interpret the lack of a proper warning to leave the manufacturer strictly liable to the injured plaintiff, others recognize that the examination of a warning's propriety follows the logic of a negligence analysis.24 re­ gardless, even for unavoidably unsafe products, a ''proper warning" is re­ quired. the persistent question with regards to prescription drugs, a question without a consistent answer, is to whom the warning must be given. as noted in the introduction of this article, many jurisdictions have adopted the lid, a doctrine which designates the physician as the appropri­ ate recipient of warnings about prescription drugs. in fact, one court noted that, as of 2004, thirty-four states had officially adopted the lid, while even more had adopted the doctrine indirectly.25 however, another court claimed that, as of 2007, only twenty-two states had expressly adopted the · lid by statute or higher court. 26 though not accepted in all jurisdictions, the lid has become a fairly well-established exception to the general rule that manufacturers must warn the actual consumer of their product's risks.27 courts provide different justifications for their adoption of the lid. many of the justifications involve preservation of the patient-physician rela­ tionship.28 while not providing much detail, some courts have stated that the physician is the best person to warn the patient.29 presumably, these courts believe that the physician can personally determine whether the pa­ tient understands the warning, because they have stated that consumers would have difficulty comprehending medication warnings without the as­ sistance of their doctor.30 in addition, a physician can provide an independ23. restatement (second) of torts § 402a cml k (1977). 24. see hahn v. richter, 628 a.2d 860, 867 (pa. super. ct. 1993) (citing harford mu­ tual ins. v. moorhead, 578 a.2d 492 (pa. super. ct. 1990)). 25. larkin v. pfizer, inc., 153 s.w.3d 758, 767 (ky. 2004). 26. west virginia ex rei. johnson & johnson cotp. v. karl, 647 s.e.2d 899, 905 (w. va.2007). 27. see perez v. wyeth lab. inc., 734 a.2d 1245, 1255 (n.j. 1999) (discussing the general rule that manufacturers must warn foreseeable, ultimate consumers about their prod­ ucts). 28. see, e.g., id (relaying that one of the "theoretical bases" for the ud is a ''reluc­ tance to undermine the doctor patient relationship"). 29. see, e.g., larkin, 153 s.w.3d at 763; see, e.g., vitanza v. upjohn, 778 a.2d 829, 837 (conn. 2001). 30. mendez montes de oca v. aventis, 579 f. supp.2d 222, 227-28 (d. puerto rico, 76 indiana heal til law review [vol. 8:69 ent medical judgment about the appropriateness of a particular drug for the individual patient.31 courts have adopted the lid to prevent interference with these and other aspects of the patient-physician relationship.32 for in­ stance, warnings provided by the drug manufacturer may be different than those provided by the doctor, thereby undermining the trust necessary for a successful patient-physician relationship.33 another possibility is that the manufacturer's warnings may frighten the consumer to the point that he or she decides not to take life-saving or life-prolonging medication.34 beyond concerns about the patient-physician relationship, courts, in support of the lid, have stated that manufacturers lack an effective way to communicate with the ultimate consumers of their product. 35 jurisdictions also vary in their application of exceptions to the lid. some of the most commonly recognized exceptions include mass immun­ izations and contraceptives. 36 in these cases, one of the basic premises for the application of the lid is missing the dialogue between physician and patient is limited or perhaps even non-existent in the decision to take the medication.37 another, less uniformly applied, exception to the lid occurs when the fda requires a direct warning to the patient about medications or devices. 38 here again, it is presumed that the physician plays less of a role when the manufacturer must directly communicate with the consumer. in considering the exceptions to the lid, one court decided not to adopt the lid because too many exceptions would simultaneously have to be adopted to 'justly utilize[]" the doctrine. 39 in sum, the exceptions to the lid vary greatly among jurisdictions. the common law landscape of the lid becomes even more compli­ cated when considering the judicial response to drug promotion. at least 2008); johnson & johnson corp., 647 s.e.2d at 905 n. 9. 31. eck v. parke, davis & co., 256 f.3d 1013, 1018 (loth cir. 2001) (quoting ed­ wards v. basel phann., 933 p.2d 298, 300 (ohio 2008), and emphasizing the requirement that a physician "exercise independent judgment" in prescribing medication). 32. see, e.g., perez, 734 a2d at 1255 (providing as the first theoretical basis for the lid that "courts do not wish to intrude upon the doctor-patient relationship"). 33. see, e.g., id. 34. see, e.g., larkin, 153 s.w.3d at 764. 35. see, e.g., id 36. see, e.g., west virginia er rei. johnson & johnson v. karl, 647 s.e.2d 899, 911 (w.v. 2007). but see in re norplant, 165 f.3d 374 (5th cir. 1999) (finding uo applicable to cases involving implantable contraceptive device). 37. see, e.g., jeffrey j. wiseman, another factor in the "decisional calculus": the learned intermediary doctrine, the physician-patient relationship, and direct-to­ consumer marketing, 52 s.c. l. rev. 993, 1005 (2001) (relating that patients at mass im­ munizations do not receive individualized attention from a physician); macdonald v. ortho pharmaceutical corp., 475 n.e.2d 65, 69 (mass. 1985) (stating that consumers of contracep­ tives are much more involved in the decision to use the medication, the medication is used for the long-term even though the patient will only interact with the physician on an annual basis, and that it is difficult for the physician to cover all of the risks and benefits of the con­ traceptive medication in an annual exam). 38. edwards v. basel pharm., 933 p.2d 298,301 (okla.l997). 39. johnson & johnson, 641 s.e.2d at 913. 2011] direct-to-consumer advertising of pharmaceuticals 77 one court has allowed an exception to the lid for "overpromotion" of a drug to physicians.40 with respect to dtc advertising, several courts have applied the lid even when drug promotion played a role in the case.41 in contrast, the new jersey supreme court expressly created an exception to the lid when the pharmaceutical manufacturer has advertised directly to the public.42 to confuse the matter further, another court declined to adopt the lid in part because the first court to suggest the doctrine partially relied on the fact that no representations had been made directly to the public about the drug.43 most courts assume that the prescribing physician functions as a learned intermediary when no general exception is applicable. however, courts should consider if the physician actually did function as a "learned intermediary" in each case where no general exception to the lid exists, rather than rely on an assumption that is open to interpretation. judicial opinions generally do not list the characteristics of a true "learned interme­ diary;" nevertheless, by looking to judicial reasoning in deciding to accept, reject, or create exceptions to the lid, one can decipher certain criteria that a physician must have in order to function as a "learned intermediary." these criteria are as follows: 1) a patient-physician relationship must ex­ ist;44 2) the physician must know the characteristics of the prescribed medi­ cation;45 3) the physician must know the patient's current medical status and medical history;46 4) the physician must make an independent medical 40. brown v. glaxo, inc., 790 so.2d 35, 40 (la. ct. app., 2001) (finding that verbal representations about medication, made to pharmacists and physicians, could override the written warnings to the physicians, thereby allowing for an exception to the lid). 41. see, e.g., in re meridia, 328 f.supp.2d 791, 811-12 (n.d. ohio 2004) (stating that most states have not applied an exception to lid in face of dtc, and, therefore, a federal court is limited by the decisions of those states); in re norplant, 165 f.3d at 379 (finding that texas law applied the lid wherever a physician-patient relationship existed, regardless of the presence ofdtc advertising); hackett v. g.d. searle & co., 246 f.supp.2d 591 (w.d. tex. 2002) (finding that lid applies even when dtc applies). 42. perez v. wyeth laboratories inc., 734 a.2d 1245, 1247 (n.j. 1999) (stating that "a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product."). 43. johnson & johnson, 641 s.e.2d at 907 (stating that "(t]he marcus court clearly found significance in the fact that no representations had been made directly to the plain­ tiff'). 44. see, e.g., in re norplant, 165 f.3d at 379 (stating that "as long a physician-patient relationship exists, the learned intermediary doctrine applies."). 45. see, e.g., johnson & johnson, 641 s.e.2d at 905 (quoting terhune v. a.h. robins co., 577 p.2d 975, 978 (wash. 1978) as saying of the physician, "(i]t is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or ad­ ministers to or uses on his patients.''); vaccariello v. smith & nephew richards, inc., 763 n.e.2d 160, 164 (ohio 2002) (quoting themselves in tracy v. merrell dow pharm., inc., 569 n.e.2d 875, 878 (ohio 1991) as stating that it is the physician's "duty to know ... the quali­ ties and characteristics of the drugs or products to be prescribed.''). 46. see, e.g., vaccariello, 163 n.e.2d at 164 (quoting themselves in tracy, 569 n.e.2d at 878 as stating that it is the physician's "duty to know the patient's condition.") and ma78 indiana health law review [vol. 8:69 judgment in choosing to prescribe the drug;47 5) the physician must play a meaningful and significant role in prescribing the medication and evaluat­ ing the patient;48 6) the physician should be the sole source, or at the very least the primary source, of information about the disease and drug;49 and 7) the physician must be in a position to reduce the risks of harm from the drug. 5° drug promotion affects a physician's ability to fulfill some of these criteria. hence, these criteria could provide further support for a general exception to the lid for dtc advertising, or could be used on a case-by­ case basis to determine if the physician functioned as a true .. learned inter­ mediary," making it possible to apply the lid. iii. dtc advertising warrants a general or case-by-case exception to the lid, especially given recent changes to the hbaltii care system exceptions to the lid are frequently applied when the original justifi­ cations are absent, most notably when there has been an erosion of the pa­ tient-physician relationship51 such that relying solely on the physician to provide the warnings is inappropriate, impossible, or naive. in addition, the lid cannot be applicable when there is no true ''learned intermediary" as defmed by the criteria gleamed from case law. using recent data, this sec­ tion of the article explores how drug promotion alters the patient-physician relationship and makes it difficult for a physician to meet the criteria of a kripodis v. merrell-dow pbarm., inc., 523 a.2d 374, 378 (pa. super. ct. 1987) (quoting leibowitz v. ortho pharm. corp., 307 a.2d 449, 457 (pa. super. ct. 1973) as saying that the physician must use the "personal medical bistoty of the patient" to determine if a drug should be prescribed). 4 7. see johnson & johnson, 641 s.e.2d at 905 (quoting terhune, 511 p .2d at 978 as saying that the physician must "exercise an independent judgmenf') and makripodis, 523 a.2d at 378 (quoting leibowitz, 301 a.2d at 457 as saying that the physician should "use his independent medical judgment"). 48. see, e.g., in re norplant, 165 f.3d at 379 (giving the fact "that physicians play a significant role in prescribing norplanf' as one reason to apply the lid); macdonald v. ortbo pbarm. corp., 475 n.e.2d 65, 69 (mass. 1985) (explaining that annual interaction between patient and physician for birth control prescriptions is not frequent enough, given other factors, to apply the lid); and perez v. wyeth laboratories inc., 734 a.2d 1245, 1255 (n.j. 1999) (suggesting that meaningful interaction between patient and physician is required to apply the lid when stating that "because managed care bas reduced the time allotted per patient, physicians have considerably less time to inform patients of the risks and benefits of a drug."). 49. see johnson & johnson, 641 s.e.2d at 905 (quoting terhune, 511 p.2d at 978 as saying "[t]he physician decides what facts should be told to the patient.'') and mckee v. american home products corp., 782 p.2d 1045 (wash. 1989) (finding pharmacist bas no duty to wam of risks of prescription drug and citing to several cases implying the lid is applicable because the physician is the sole or primaty source of information). 50. see, e.g., vitarml v. upjobn, 778 a2d 829, 841 (conn. 2001) (stating ''the pre­ scribing physician of a prescription drug is the person best able to take or recommend pre­ cautions against the [potential] harm."). 51. see, e.g., perez, 134 a2d at 1255-56. 2011] direct-to-consumer advertising of pharmaceuticals 79 "learned intermediary." changes to the patient-physician relationship that have occurred independent of, but at the same time as, increasing drug pro­ motion are also evaluated. these changes affect both the way in which drug promotion alters patient-physician encounters and the back drop against which the lid is justified. the data will demonstrate that the pres­ ence of dtc advertising in the modern healthcare system supports application of an exception to the lid. . prescription drugs can be divided into therapeutic and non­ therapeutic,52 or lifestyle and medically necessary drugs.53 the basic idea behind this division is that patients play a larger role and physicians a smaller role in decisions regarding medications that are not medically nec­ essary or lifesaving, 54 thereby weakening the rationale for the lid. 55 the smaller the role played by the physician in a particular instance, the less likely the physician will fulfill the "learned intermediary" criteria of playing a meaningful or significant role in prescribing and evaluating the patient. in other words, the prescription of lifestyle drugs generally weakens the rea­ soning used to apply the lid in all cases, but may also make the lid inap­ plicable in certain cases where the physician no longer meets the definition of a "learned intermediary." the restatement (second) of torts implies, and has been interpreted by some courts to mean, that the exception to strict liability for unavoidably unsafe products rests on the idea that these medications "possess[] such a high degree of social need."56 thus, by inference, manufacturers of purely lifestyle drugs could be considered subject to strict liability, regardless of the warning content or to whom it was directed. many of the drugs that are advertised directly to the consumer could be considered "lifestyle" medica­ tions. 57 in addition, a large percentage of advertised pharmaceuticals treat chronic conditions;58 these drugs affect long-term health outcomes that may also be altered by other lifestyle factors. 59 it is difficult to say if these drugs 52. wiseman, supra note 37, at 1010. 53. perez, 734 a.2d at 1257. 54. seewiseman,supranote31,at 1010. 55. see richardson, supra note 12, at 1028-29 (explaining that the insulation from liability by the lid is justified, in part, by the importance of their products to saving lives). 56. hill v. searle, 884 f.2d 1064, 1068 (8th. cir. 1989); see also restatement (second) of torts,§ 402a cmt k (1977) (mentioning the rabies vaccine as an example of unavoidably unsafe products and finding that the serious risks of the vaccine are justified by the horrible consequences of the disease). 57. for instance, advertisements for erectile dysfunction are common, as well as ad­ vertisements for medications meant to enhance looks, such as latisse. 58. donahue, supra note 2, at 676. 59. for example, a person's cholesterol may also be lowered with diet and exercise and a person's blood pressure may be lowered through weight loss. j.s. lin et al., behav­ ioral counseling to promote physical activity and a healthful diet to prevent cardiovascu­ lar disease in adults: a systematic review for the u.s. preventive services task force, 153 annals of internal med. 736 (2010) (finding small reductions in cholesterol levels with more healthful diet and increased exercise) and m.l. tuck et al., the effect of weight re80 indiana health law review [vol. 8:69 would be considered medically necessary or some other intermediate cate­ gory. regardless of how the advertised medication is classified, dtc adver­ tising and patient and physician views about such advertising affect many patient-physician interactions. the majority of the public have generally negative views of dtc promotion of prescription pharmaceuticals, 60 with just over a quarter of the public feeling dtc advertising makes them more informed about their health conditions,61 and slightly over ten percent be­ lieving dtc advertising motivates care-seeking behavior.62 physicians generally have concerns about the possibly incomplete and biased infor­ mation that may be presented in such advertisements,63 although more than forty percent of physicians surveyed felt that dtc advertising helped better inform their patients about their health problems.64 furthermore, more than half of physicians felt dtc advertising can encourage individuals to seek medical care.65 most importantly, more than half of physicians felt that dtc advertising has ·ted to specific medication requests and changed pa­ tient expectations of them;66 between ten and fifteen percent of the public reported that dtc advertising had led to specific medication requests or changed their expectations of their physicians.67 it has been found that between eighteen and forty-four percent of indi­ viduals who see dtc advertising discuss either the advertised drug or the condition with their doctor, with about twenty-five percent of those discus. sions including a request for the advertised medication. 68 in those cases where a medication is discussed as a result of dtc advertising, the physi­ cian is not the sole source, and may not even be the primary source, of in­ formation about the medical condition or treatment. the physician, in those cases, might not meet the definition of "learned intermediary'' as outlined by the common law. most doctors do believe that dtc advertising encourages patients to talk about issues that they might not otherwise discuss. 69 some advertising goes beyond encouraging discussion of certain topics. for example, one company provided consumers with specific questions to ask and suggested duction on blood pressure, plasma renin activity, and plasma aldosterone levels in obese patients, 304 new eng. j. med. 930 (1981) (finding a reduction in blood pressure with weight loss in obese patients). 60. robinson et al., supra note 1, at 431. 61. /d. at 429. 62. /d. 63. /d. at 428. 64. /d. at 429. 65. /d 66 • . id 67. /d. 68. ga0-07-54, supra note 4. 69. elizabeth murray et al., direct-to-consumer advertising: physicians' views of its effects on quality of care and the doctor-patient relationship, 16 j. am. bn. fam. med. 513, 518 (2003). 2011] direct-to-consumer advertising of pharmaceuticals 81 information the patient should share with his or her physician. 70 in that case, the company was unabashedly trying to guide the patient-physician discussion by providing prompts and giving prospective consumers a chance to prepare answers for potential physician questions. in other words, dtc advertising alters many patient-physician encounters by influ­ encing the topics and direction of discussion. furthermore, in fewer than half of the conversations initiated by patients because of dtc advertising did the physician perceive that the patient wanted his or her opinion, rather the patient was understood to want a specific intervention. 71 almost half of individuals who participated in a particular survey re­ ported they would be disappointed if a physician did not prescribe a re­ quested medication, and a quarter would try to change the physician's opinion.72 from a physician perspective, under a quarter of surveyed physi­ cians admit that dtc advertising has affected their own prescribing practic­ es.73 however, "patient demand is the most commonly offered physician explanation for inappropriate prescribing."74 more than seventy percent of patients who request a drug that they have seen advertised receive a pre­ scription for that medication, even though fifty percent of these prescrip­ tions were deemed inappropriate. 75 in other words, dtc advertising affects the patient-physician relationship by altering treatment outcomes, and may invalidate the application of the lid since the physician is not making an independent medical judgment, as required by the common law criteria of a "learned intermediary." one study found the public felt dtc advertising had less influence on the patient-physician relationship than physicians reported. 76 more physi­ cians felt that dtc advertising had a positive effect on the patient-physician relationship than a negative effect; those physicians reporting a positive effect tended to have more clinically appropriate patient inquiries, doctor compliance with patient requests, and a sense that the patient was taking responsibility for his or her own health. n on the other hand, the relation­ ship was perceived as being negatively affected by dtc advertising when the advertisement led to requests or information that the doctor felt was in70. preparing for your viagra talk: what to ask your doctor, pfizer, inc. (aug. 20 i 0), http://www.viagra.com/viagra-prescriptionlviagra-questions.aspx; preparing for your viagra talk: what to tell your doctor, pfizer, inc. (aug. 20io), http://www.viagra.com/ viagra-prescriptionlviagra-questions/what-to-tell-your-doctor.aspx. 71. murray et al., supra note 69, at 521. 72. robinson et al., supra note 1, at 428. 73. !d. at430 74. id. at431. 75. barbara mintzes et al., how does direct-to-consumer advertising affect pre­ scribing? a survey in primary care environments with and without legal dtca, i69 can. men. ass'n j. 405 (2003). 76. robinson et al., supra note i, at 430. 77. murray et al., supra note 69, at 519. 82 indiana health law review [vol. 8:69 appropriate. 78 therefore, when doctor and patient opinion differed, dtc advertisement was viewed as negatively affecting the relationship. regard­ less of patient or physician views, there is little doubt that dtc advertising alters the patient-physician relationship the lid is meant to protect. dtc advertising changes the information the patient has with respect to treat­ ment and condition, alters views on proper physician roles, influences the content of discussion, and can affect treatment decisions. in addition, dtc advertising may make it impossible for the physician to function as a true "learned intermediary" because it provides another influential source of in­ formation to the patient and influences the physician's judgment. the rise in dtc advertising has occurred alongside many changes to the health care system, one of which is the increasing importance of the doctrine of informed consent. informed consent allows a patient to intelli­ gently exercise patient autonomy, even requiring respect for a patient's de­ cision not to take a clearly lifesaving medication. 79 the lid was more uniformly accepted and applied earlier than the doctrine of informed con­ sent and was based on a world where paternalistic medicine was the norm. 80 the widespread application of informed consent has altered the basic duties of the patient-physician relationship, placing more responsibility on the pa­ tient and less on the physician, and strikes at the most basic rationale for the lid. in fact, some courts have declined to apply the lid in part because informed consent heavily undermines the support for the doctrine. 81 yet, it is logical that the lid would apply if the physician is the sole source of in­ formation about the diagnosis and treatment and utilizes independent medi­ cal decision making in deciding what information to share with the patient. with dtc advertising, the physician is not the sole source of information and may be biased by dtc advertising in his or her decision making. in other words, the rise of informed consent alone may weaken, but not negate the rationale for the lid. however, when dtc advertising occurs against the backdrop of informed consent, the physician is no longer a true "learned intermediary." since the patient makes the ultimate decision regarding treatment, it is conceivable that dtc advertising has more of an effect on prescription drug consumption currently, than if dtc promotion occurred in a world of paternalistic medicine. in addition to the rise of informed consent, other changes to the prac78. !d. 79. see april l. foreman, web of manipulation: the learned intermediary doctrine and direct-to-consumer advertising on the world wide web, 35 j. marshall l. rev. 97, 108-09 (2001) (noting increased "patient autonomy"); perez v. wyeth laboratories inc., 734 a.2d 1245, 1255,1257 (n.j. 1999) (discussing increased importance of and near universal application of the doctrine). 80. perez, 734 a.2d at 1255 (recounting the prior norm of medical practice where patients somewhat blindly followed a physician's advice). 81. see west virginia ex rei. johnson & johnson corp. v. karl, 647 s.e.2d 899, 910 (w.va. 2007) (quoting perez, 734 a.2d at 1257). 2011] direct-to-consumer advertising of pharmaceuticals 83 tice of medicine have altered the patient-physician relationship as to call into question the justifications for the lid. managed care, 82 the provision of health insurance through employers, the increasing subspecialization of medicine, increased access to technology and easy access to medical infor­ mation on the internet, among other changes, have contributed to the fact that patients do not stay with the same physicians for life. furthermore, physician time spent in patient contact has decreased, and patients are cared for by a confusing group of unconnected doctors. in other words, numerous changes to the practice of medicine, independent of the rise of dtc adver­ tising, affect the basis on which the lid was defined, make it more difficult for a physician to function as a true "learned intermediary," and lessen the strength of the patient-physician bond. with the weakening of this bond, patients are likely to rely more on information they have gathered them­ selves rather than information solely from the physician. therefore, dtc could have more of an effect on the patient's decisions in these settings. an exception to strict liability for product manufacturers was created for unavoidably unsafe products, such as prescription pharmaceuticals.83 this exception to strict liability seems to have been created for highly use­ ful or necessary products, and it may not even apply to completely lifestyle drugs. for drugs covered by the unavoidably unsafe doctrine, the lid re­ quires warning only the physician of risks of the prescription medication. 84 exceptions to the lid are based mostly on a weak or nonexistent patient­ physician encounter. dtc advertising erodes the patient-physician rela­ tionship by altering expectations of the relationship, shaping discussions during patient encounters, and affecting prescribing practices, among other influences. in the presence of dtc promotion, physicians may no longer meet the criteria of a "learned intermediary," since they are not the sole source of information for the patient, and their judgment may be affected by such advertising. changes to the health care system independent of dtc advertising weaken the reasoning for application of the lid and increase the potential influence of dtc advertising. these changes also make it more difficult for physicians to be true "learned intermediaries." when de­ ciding how dtc advertising should affect liability of the manufacturer, all of these issues should be considered.· 82. perez, 734 a.2d at 1255 (discussing how managed care has reduced the amount of time a physician spends with a patient, leaving them unable to adequately warn the patient about the drug). 83. see restatement (second) of torts, § 402a cmt. k (1977). 84. see mcpheron v. searle lab., inc., 888 f.2d 31 (5th cir. 1989) (stating that those courts who have adopted comment k to section 402a of the restatement (second) of torts have required that proper warnings regarding ''unavoidably unsafe" medications be given only to the prescribing physician). 84 indiana health law review [vol. 8:69 iv. drug promotion to the physician provides further support for a general or case-by-case exception to the lid85 through the lid, physicians buffer the pharmaceutical company from liability for drug promotion to the consumer. however, pharmaceutical companies will also promote their products to physicians. such direct-to­ physician marketing allows pharmaceutical companies to exert influence over the physician who already bears the burden of dtc marketing liabil­ ity. not only is it unfair for the doctor to bear liability for the entity which influences him or her through the subversive effects of advertising, but ad­ vertising directly to the physician, like dtc advertising, intrudes into the patient-physician relationship. the patient-physician relationship is a rec­ ognized fiduciary relationship.86 fiduciary relationships are held with high regard, and they are consequently accompanied by weighty responsibilities and protected legally from invasion or demise due to outside influences. 87 given that fiduciary relationships are protected legally, the same pharma­ ceutical company that influences the interaction and outcomes of the pa­ tient-physician relationship by advertising to both patients and physicians should not be protected from liability. the effect of dtc advertising on both patient and physician was explored in the previous section. this sec­ tion highlights the effects of direct-to-physician advertising on the patient­ physician relationship. this section further shows that it is good policy, with respect to both fairness and the desire to protect fiduciary relation­ ships, to hold drug manufacturers that promote their medications to physi­ cians and patients liable for such promotion. not only is it good policy to not allow pharmaceutical manufacturers to be insulated from liability with the lid, but also, like dtc advertising, the effects of direct-to-physician marketing make the lid inapplicable. a physician who has been influenced by direct-to-physician drug promotion no longer meets the criteria of a "learned intermediary." the data presented 85. a full exploration of the effects of drug promotion directly to physicians is beyond the scope of this article. instead, sufficient data is presented to show how direct-to-physician advertising impedes a physician from functioning as a "learned intermediary''. 86. see david orentlicher, health care reform and the patient-physician relation­ ship, 5 health matrix 141, 147 (1995) (noting that the patient-physician relationship has traditionally "been viewed as a fiduciary relationship in which the physician owes the patient a fundamental duty to place the patient's interests first, above not only the physician's per­ sonal interests but also the interests of other patients."); see also petrillo v. syntex laborato­ ries, inc., 499 n.e.2d 952, 956-57 (ill. app. ct. 1986) (noting that public policy favors the fiduciary relationship between a patient and physician, as reflected in the ''promulgated code of ethics adopted by the medical profession and ... the fiduciary relationship, recognized by courts in illinois as well as courts throughout the united states ... . j. 87. see marc a. rodwin, strains in the fiduciary metaphor: divided physician loy­ alties and obligations in a changing health care system, 21 am. j. l. & men. 241, 248 (1995) (noting that "[t]raditional fiduciaries are held accountable by federal or state statutes, by courts, and by regulatory agencies."); see also petrillo, 499 n.e.2d at 956-57 (finding that certain ex parte conferences with a treating physician are not permitted). 2011] direct-to-consumer advertising of pharmaceuticals 85 in this section demonstrates how a physician who has been subjected to di­ rect-to-physician advertising is no longer making independent medical judgments. direct-to-physician advertising is prevalent and successful. although pharmaceutical companies have increased the amount spent on dtc adver­ tising at a faster rate than that spent on direct-to-physician promotion, more money is still spent each year on advertising to the physician rather than to the general public. in 2005, $7.2 billion was spent promoting pharmaceuti­ cals to physicians. 88 direct-to-physician advertising can take many forms, including in-person visits with drug representatives and advertisements in professional journals. drug representatives are employees of the pharma­ ceutical company who provide doctors with information about the compa­ ny's drugs, samples, and gifts. as of 2005, there was one drug representative per six physicians in the united states, 89 and physicians were found to "me[ e ]t with pharmaceutical representatives about 4 times a month."90 while drug companies are not the sole source of information about medications for physicians, they do serve as a convenient and common source of information about medications, particularly new medications. obviously, a pharmaceutical manufacturer will present research that demonstrates the efficacies and benefits of their medications. drug compa­ nies, in a very practical way, not only provide information that becomes the knowledge base on which prescriptions are written, but also, by deciding which information to present and how to present it, they can shape a physi­ cian's perspective about certain medications. as might be expected, are­ view article found that pharmaceutical promotion to physicians had a negative effect on knowledge about the promoted medication.91 the same article reported "an ... association between meetings with pharmaceutical representatives and formulary addition requests," and found an effect on prescriptions (e.g., "prescribing cost, nonrational prescribing, awareness, preference and rapid prescribing of new drugs, and decreased prescribing of generic drugs.").92 in other words, physicians are not making independent 88. ga0-07-54, supra note 4, at 5. 89. adriane fugh-bennan & sbahram ahari, following the script: how drug reps make friends and influence doctors, pws med., 0624 (apr. 24, 2007), http://www. plosmedicine.org/article/info%3adoi%2f 10.1371 %2fjournal.pmed.0040 150. 90. ashley wazana, physicians and the pharmaceutical industry: is a gift ever just a gift?, 283 jama 373, 375 (2000). 91. id. at 378 (stating that interactions with the pharmaceutical industry have been associated with an "inability to identify wrong claims about medication"). 92. !d. at 375; see also what impact does pharmaceutical promotion have on behav­ ior?, drug promotion database (june 2, 2003), http://www.drugpromo.info/read­ reviews.asp?id=4 (stating, "together these studies provide convincing evidence that doctors who regard promotion more highly, and report relying on it more as a source of information about drugs, prescribe more drugs, prescribe less rationally, and prescribe new drugs earlier than other doctors" and discussing a study that "found that doctors who interacted with a 86 indiana health law review [vol. 8:69 treatment decisions based on· unbiased infonnation. through the subtle ef­ fects of drug promotion, phannaceutical companies affect the likelihood of prescribing certain medications and directly affect the outcome of patient encounters. given the psychological effects of advertising, the influence of direct­ to-physician and dtc advertising may be more invasive into the patient­ physician relationship than expected.93 for instance: hanson and kysar, two of the leading legal scholars of behavioralism, have found that first and foremost, "individuals are vulnerable to manipulation by those in a position to influence the decisionmaking con­ text." in other words, commercials do not educate or stimulate but rather manipulate and persuade in a uni­ lateral manner.94 one author cited that fifty-seven percent of physician-directed adver­ tising does not have educational value,95 . and the purpose of such advertis­ ing is merely to increase prescription sales through means other than scientific data demonstrating the benefits of a particular medication. "gifts create both expectation and obligation"96 and thus, it can be said that physi­ cians are also subject to the effects of gifting from phannaceutical repre­ sentatives. however, gifts have also been found to be "correlated with the belief that phannaceutical representatives have no impact on prescribing behavior."97 unfortunately, those doctors "influenced by phannaceutical marketing nonetheless believe that their infonnation is scientific and unbi­ ased."98 additionally, pharmaceutical representatives are privy to a physi­ cian's prescribing practices, and can therefore tailor their message about different drugs to the practices of that physician, making the sales pitch more effective than mass marketing alone.99 the psychological consecompany were between 9 and 21 times more likely than other doctors to have requested that a drug made by that company be added to the formulary."). 93. richardson, supra note 12, at 1037 (stating of the perez decision, "section iii is arguably the most important part of perez because it recognizes that dtc advertising has a significant psychological impact on consumers that changes the relationship between the physician and patient. ... it is these changes that warp the function of the lid from protect­ ing important physician prerogatives to simply protecting manufacturers."). 94. /d. at 1041. 95. /d. at 1043. 96. fugh-berman & ahari, supra note 89, at 0621. 97. wazana, supra note 90, at 375-6. 98. howard brody, the company we keep: why physicians should refuse to see pharmaceutical representatives. 3 annals of fam. med. 82, 83 (2005); see also wazana, supra note 90, at 375 (finding that physicians "believe that representatives provide accurate information about their drugs and are equivocal in their beliefs that representatives could provide accurate information on established or alternative drugs"). 99. fugh-berman & ahari, supra note 89, at 0623; ims health corp. v. rowe, 532 f .supp.2d 153, 158 (d. me 2008). 2011] direct-to-consumer advertising of pharmaceuticals 87 quences of dtc and direct-to-physician advertising are intended to be sub­ tle, and therefore harder to protect against. 100 however, because the adver­ tising affects how one thinks, feels, and interacts with respect to a certain diagnosis or drug, dtc and direct-to-physician advertising have a signifi­ cant effect on the patient-physician relationship and the independence of a physician's medical judgment. as the previous section demonstrated, even dtc advertising can af­ fect a doctor's treatment decisions when coupled with the effects of direct­ to-physician advertising. whether the physician's prescribing decisions are independent should be called into question when drug promotion has oc­ curred. these concerns are multiplied by the fact that the same drugs are frequently and simultaneously promoted to both patient and physician.101 when a physician does not make an independent medical judgment because he or she has been influenced by dtc or direct-to-physician advertising, the physician no longer meets the definition of a "learned intermediary," and the lid should not be applied. this logic could be used to justify a general exception to the lid for either dtc advertising or direct-to­ physician promotion. this logic could also be used on a case-by-case basis to find individual exceptions to the lid. besides calling into the question the presence of a "learned intermediary," drug promotion intrudes into the patient-physician fiduciary relationship by influencing both parties to that relationship. such an intrusion should be accompanied by an appropriate legal response in order to protect that fiduciary relationship. lastly, it is fundamentally unfair for physicians who no longer meet the criteria of a "learned intermediary" because of drug manufacturer influence to bear that manufacturer's liability for drug promotion. pharmaceutical manufacturers should be held liable for their intrusions into patient-physician relation­ ships, rather than being sheltered from liability under the lid. v. dtc advertising creates a near or actual fiduciary relationship between patient and pharmaceutical manufacturer fiduciary relationships are defined by the fact that one party is to act for the benefit of the other. to ensure such selfless action, the law imposes certain strict duties upon the fiduciary. further, fiduciary relationships do not have to be formally established.102 case law and scholarship elaborate 100. even those physicians who attempt to limit or eliminate pharmaceutical industry influence in their practice may have difficulty. the industry now funds a large portion of research, and such funding has been correlated with the publication of those studies with positive findings. what impact does pharmaceutical promotion have on behavior?, drug promotion database (june 2, 2003), http://www.drugpromo.info/read-reviews.asp?id=4. 101. ga0-07-54, supra note 4, at 14. l 02. fiduciary relationship, la w.com dictionary, http:/ /dictionary.law .com/default. 88 indiana health law review [vol. 8:69 on what may be required to create a fiduciary relationship, as well as the relationship's accompanying legal responsibilities. as an example, a minnesota court recently stated rather simply that "[f]iduciary relationships arise when one person trusts and confides in an­ other who has superior knowledge and authority. a court may find the nec­ essary relationship in light of 'moral, social, domestic, or merely personal factors. "'103 a 2008 seventh circuit decision went so far as to state a pre­ sumption for fiduciary relationships when "one party has a superior position and sustains a substantial advantage over the other."104 the inherent rela­ tionship between pharmaceutical companies and patients meets the standard established by the two cases above. first, there is little doubt that drug companies possess superior knowledge of particular medications or condi­ tions as compared to the average consumer of their drugs. second, the su­ periority of the drug companies may be heightened by the increased vulnerability experienced by individuals with certain ailments when view­ ing pharmaceutical advertisements.105 as discussed in the previous sec­ tions, advertising is persuasive and subtle, allowing the drug companies to gain authority or influence over the consumers. in addition, some pharma­ ceutical companies advertise not only their products, but also the company itself. for instance, companies may highlight the moral, responsible way in which they perform vital social functions.106 such advertising, in conjunc­ tion with online quizzes or applications for financial assistance, create a sense of trust and confidence in the drug manufacturer. therefore, dtc advertising may create a fiduciary relationship through the fiduciary stand­ ards discussed by these two courts. however, other courts have outlined more specific requirements to establish certain fiduciary relationships. for the attorney-client and doctor-patient relationships, it appears that these more specific requirements frequently include the giving of individualized advice and reasonable reliance on that advice. the first step in forming a fiduciary relationship usually falls· to the beneficiary he or she seeks the advice or services of the prospective fidu­ ciary,107 with some courts noting that the services should be sought because aspx?selected=745&bold=%7co/o7co/o7c0/07c (last visited april6, 2010). 103. swenson v. bender, 764 n.w.2d 596,601 (minn. ct. app. 2009). 104. interactive intelligence, inc. v. keycorp, 546 f.3d 897,900 (7th cir. 2008). 105. hoopes v. hammargren, 725 p.2d 238,242 (nev. 1986) (expressing vulnerability of patients with illness). 106. see, e.g., our compmry, astrazeneca us, http://www.astrazeneca-us.com/ about-astrazeneca-us/our-company/ (last visited june 15, 2010) (stating ''not only are we working to discover the next new medicine, but we're also working to help make healthcare a more meaningful, more personal experience for patients"); corporate social responsibil­ ity, pfizer, http://www.pfizer.com/responsibility/ (last visited june 15, 2010) (advertising "[ d]oing business responsibly" and stating ''we are striving to adapt to the evolving needs of society and contribute to the overall health and wellness of our world"). 107. see catherine j. lanctot, attorney-client relationships in cyberspace: the peril and the promise, 49 duke l. j. 147, 169 (1999); douglas k. schnell, don't just hit send: unsolicited e-mail and the attorney-client relationship, 17 harvard j. l. & tech. 533, 2011] direct-to-consumer advertisjng of pharmaceuticals 89 of the fiduciary's expertise.108 there must be some voluntary response on the part of the fiduciary in order to create the relationship.109 however, the voluntary response could be minimal; the virginia supreme court has found that a physician-patient relationship can be formed "from whatever circumstances evince the physician • s consent to act for the patient's medical benefit.''110 in the case of dtc advertising, the would-be beneficiary cannot seek the advice of the pharmaceutical manufacturer through personal consulta­ tion since these advertised medications have to be obtained through a phy­ sician. however, an individual could be seen as seeking the advice of the pharmaceutical company in one of two ways: by locating the company's website and reading the information or responding to any questions on the website; or by reading or hearing advertisements in any format and pro­ cessing them sufficiently so as to use the information for a prescription re­ quest. as for the voluntary response on the part of the fiduciary, advice given through advertisements could "evince . . . consent to act for the pa­ tient's medical benefit[;]"111 after all, advice is not deserving ofthat name if it is not meant for the benefit of the recipient. yet, the advice presented in advertisements predates any request, and therefore, is not a response. how­ ever, one state's professional responsibility committee concluded that at least certain fiduciary duties can be acquired when a lawyer receives unso­ licited e-mails prompted by a website.112 in other words, the consent of the fiduciary may be preexisting if such consent is related to the "seeking" be­ havior of the beneficiary. if pharmaceutical advertising prompts an indi­ vidual to request a medication, take an online quiz, print out coupons for free trials of a prescription medication, or any number of other behaviors, a court could rationally find that the beneficiary had sought the advice of the fiduciary and the fiduciary had consented to the relationship. varying levels of personalization and specification of the advice are required in order to form a fiduciary relationship. in attorney-client rela­ tionships, general legal advice is considered insufficient to consummate such a relationship, but advice in response to specific facts discussed by a 538, 540 (2004) (citing kurtenbach v. tekippe, 260 n.w.2d 53 (iowa 1977} and restatement (third) of the law governing lawyers§ 14 cmt. c (2000)). 108. lanctot, supra note 107, at 175 (quoting from foulke v. knuck, 784 p.2d 723 (ariz. ct. app. 1989)). 109. however, one author has concluded that fiduciary relationships could be formed through unsolicited e-mails from the beneficiaries if such e-mails were prompted by the fiduciary's website. schnell, supra note 107, at 551. this view could be particularly im­ portant for pharmaceuticals, as each advertised drug frequently has its own website. 110. fruiterman v. granata, 668 s.e.2d 127, 136-37 (va. 2008) (quoting lownsbury v. vanburen, 762 n.e.2d 354, 360 (2002)). 111. id 112. schnell, supra note 107, at 549-51 (discussing state bar of arizona committee on rules of professional conduct opinion 02-04 on unsolicited e-mails and the duty of confi­ dentiality). 90 indiana health law review [vol. 8:69 client generally tends to create a fiduciary duty. 113 in finding that a doctor­ patient relationship did not exist, one court found there was no individual or specific interaction between the physician and the patient. 114 likewise, in finding that a duty to the patient did exist, a maryland court noted that the physician had advised the patient regarding his health condition.115 calling for fewer requirements to apply a duty, the kentucky supreme court found a physician owed a duty to an individual because the physician had directed the patient's family in the emergency room several times; this direction was not related to specifics of the patient's health status at al1.116 how specific and individualized the advice must be to form a fiduci­ ary relationship might depend on the subject matter of the relationship. when the subject matter concerns the more vulnerable party's health, the advice might not have to be specific to the individual's health status if it is directed to the individual or others responsible for the individual's health. it could be argued that the contrary should also be true. that is, less indi­ vidualization is required if the advice is health related. advice found in dtc advertising is health related, but has varying levels of individualiza­ tion. online surveys with feedback may be both directed at the individual and include advice specific to an individual's health status, thus satisfying either criteria. commercials and magazine or newspaper advertisements, though seen and heard by the general public, are directed at a group of indi­ viduals with certain problems or concerns; 117 in other words, there is some level of individualization in the recipient of the message. given that the advice contained within an advertisement can be unambiguous in listing symptoms and suggesting treatments based on these symptoms,118 (i.e., ad­ vertisements frequently offer specific health advice) and always has some 113. see lanctot, supra note 107, at 160-61. 114. jenkins v. best, 250 s.w.3d 680, 688 (ky. ct. app. 2007) (stating "dr. best never saw or examined jenkins, never spoke to her or consulted or gave her advice. dr. best never reviewed jenkins' chart or made any entry in it. dr. best never consulted with dr. farmer while jenkins was under his care. dr. best never issued either medical or nonmedical or­ ders. nor did she render any opinions or recommendations. she did not participate in jen­ kins' diagnosis or treatment. ... in summary, dr. best did nothing that constitutes an undertaking to render medical care to jenkins."). 115. hoover v. williamson, 203 a.2d 861, 864 (md. 1964) ("the allegations amount to more than that the doctor kept silent after review of the x-ray revelations and the findings of the consultant. the charge of affirmative misrepresentation was coupled with the charge of concealment of the consultant's recommendations and, under the circumstances, made the concealment as much a breach of duty as the affirmative misrepresentation."). 116. noble v. sartori, 799 s.w.2d 8, 9 (ky. 1990). 117. see, e.g., boehringer ingelheim!pfizer, advertisement, once-daily spiriva hand­ ihaler, family circle, oct. 2010, at 75-76 (directing their message to individuals with copd for whom rescue inhalers are not sufficient). 118. see, e.g., id. (stating that for individuals with copd, "rescue inhalers alone may not be enough" and suggesting the reader talk to their "doctor about spiriva, because it: is the only once-daily, inhaled maintenance prescription treatment for both forms of copd[; s]ignificantly improves lung function by keeping airways open[; h]elps you breathe better for a full24 hours[; and i]s not a steroid.") (alteration in original). 2011] direct -to-consumer advertising of pharmaceuticals 91 level of individualization, a court should find sufficient personalization in various forms of dtc advertising to apply at least some fiduciary duties to the pharmaceutical advertiser. while there is not a clear answer as to how individualized and specific the advice must be to form a fiduciary relationship, there is consensus on the mode of communication between the two parties. any mode of com­ munication appears to be sufficient, and face-to-face contact is not required to form a fiduciary relationship. advice given over the telephone, 119 through e-mail, 120 or over the internet may all be sufficient.121 if internet communication satisfies the requirements for forming a fiduciary relation­ ship, other modes of advertising medications directly to the consumer could be used to form a fiduciary relationship. the advice offered by pharmaceu­ tical companies in internet advertisements is usually available to the general public and further contact requires action on the part of the beneficiary. similarly, the information found in commercials or print advertisements can be read or heard by anyone and further contact must be initiated by the ben­ eficiary. the last step in forming a fiduciary relationship is reasonable reliance on such advice. 122 one author, in reviewing attorney-client relationships, found courts are very lenient in declaring the client's reliance to be reason­ able. 123 although lenient, another author concluded that it must be objec­ tively reasonable to rely on the advice.124 the more specific and particular the advice, the more reasonable the reliance.125 with respect to dtc adver­ tising, it could be argued that consumers should recognize advertising for what it is, making reliance unreasonable. on the other hand, the persuasive effects of advertising, the individualized advice found in drug promotion, and the advertiser's superior knowledge should be considered when deter­ mining reasonable reliance. given that dtc advertising has been shown to increase pharmaceutical sales, it seems clear that a large amount of the pop­ ulation relies in part on advice within advertisements. because reliance on 119. alissa r. spielberg, online without a net: physician-patient communication by electronic mail, 25 am. j. l. &med. 267,292 (1999). 120. see id. at 292-93. 121. see, e.g., reynoso v. neary, 315 b.r. 544 (bap. 9th cir. 2004) (finding that individuals who created and operated website that completed bankruptcy petitions amounted to the unauthorized practice oflaw). 122. see lanctot, supra note 107, at 160-61 ("[c]ourts traditionally have been willing to infer attorney-client relationships when lawyers give specific legal advice to laypeople under circumstances in which it would be reasonable for them to rely on the advice."). 123. id. at 184 (stating "courts are willing to take a broad view of reasonableness"). 124. schnell, supra note 107, at 540 (stating "the belief must be objectively reasonable under the circumstances"). 125. see lanctot, supra note 107, at 183 (stating "it is reasonable for a putative client to rely on advice that is specifically tailored to his particular request"); schnell, supra note 107, at 543, ("[i]f the lawyer is responding to a specific question or offering advice on specific facts, she is much closer to an implied attorney-client relationship because of the potential for reasonable reliance than if she is just answering a general question about the law."). 92 indiana health law review [vol. 8:69 information in drug advertisements is common, it should be found reasona­ ble in many circumstances. 126 even if advice given in drug advertisements is not found to create a fi­ duciary relationship, once the advice is given, the manufacturer clearly ac­ quires certain duties. in other words, one does not have to be held to the full set of fiduciary obligations, and all fiduciary obligations may not make sense in a pharmaceutical manufacturer-consumer relationship; rather, cer­ tain duties can and should be applied based on the circumstances. 127 one court stated that there was no doubt that the giver of advice, even gratuitous advice, has a duty of due care.128 further, the more specific and complex knowledge possessed by an individual or entity, the higher the duty to which they will be held.129 in arguing that the lid should not apply when dtc advertising has occurred, one author concluded that interactive web­ sites advertising prescription drugs allow the pharmaceutical company to "advertise[] itself into the physician's role."130 this characterization was based on the fact that the drug companies encourage consumers to discuss the drug on line and present information and advice about the drug and re­ lated condition on its website.131 it is not only websites that offer such in­ tricate information, but also other forms of advertising. because of the greater knowledge possessed by the drug manufacturer and the advice pre­ sented in advertisements, the pharmaceutical manufacturer who advertises should fulfill at least some fiduciary duties. this is particularly true when the advice revolves around something as sacred as one's health and the product is both esoteric and potentially damaging to one's wellbeing. vi. conclusion both dtc advertising and changes to the health care system have eroded the rationale for the lid. physicians are also the target of aggres­ sive pharmaceutical marketing. a physician is no longer a "learned inter126. if liability for the content of drug advertisements becomes more prevalent, it is reasonable to expect use of disclaimers in advertisements. sometimes a disclaimer can make reliance unreasonable. on the other hand, people may be reluctant to accept a disclaimer, especially if the beneficiary is not represented, unsophisticated, or when there is no affirma­ tive assent to the disclaimer. see schnell, supra note 107, at 557, 559-60 (concerning dis­ claimers in an attorney-patient relationship). 127. see hoover v. williamson, 203 a.2d 861 (md. 1964) (finding no fiduciary rela­ tionship (doctor-patient relationship), but declaring that if the doctor acts gratuitously there may be some duty to act carefully). 128. id at 863 ("[o]ne who assumes to act even though gratuitously, may thereby be­ come subject to the duty of acting carefully."). 129. see stanley v. mccarver, 92 p.3d 849, 854 (ariz. 2004) (''the standard of care imposes on those with special skills or training ... the higher obligation to act in light of that skill, training, or knowledge .... "). 130. foreman, supra note 79, at 112 (alteration in original). 131. jd. 2011] direct-to-consumer advertisjng of pharmaceuticals 93 mediary" when drug promotion shapes his or her knowledge of medica­ tions, influences prescribing behavior, and alters a physician's interpreta­ tion of patient symptoms. therefore, direct-to-physician marketing further weakens the rationale for application of the lid. in addition, marketing to the physician, like dtc advertising, intrudes into the patient-physician rela­ tionship. pharmaceutical companies should not be insulated from liability for advertising when such advertising influences the legally recognized fi­ duciary relationship of patient-physician through subversive, but real, ma­ nipulation of both parties to that relationship. given that drug promotion weakens the patient-physician relationship and makes it difficult for a phy­ sician to function as a true "learned intermediary," courts should eliminate the lid and impose joint liability on the part of the pharmaceutical manu­ facturer and the physician in dtc advertising cases.132 should a general exception to the lid for dtc advertising not be accepted, courts should look to the criteria for a learned intermediary on a case-by-case basis. given the presence of advice on matters relating to personal health in dtc advertising, such advertising should create fiduciary duties, or perhaps even fiduciary relationships, between drug consumer and drug manufactur­ er. to determine the types of duties and whether an actual fiduciary rela­ tionship exists, courts should analyze the content and mode of advertising, paying special consideration to the level of individualization of the advice for the drug or condition.133 imposing the lid when dtc advertising has occurred provides the phar­ maceutical manufacturers full license to advise on and impact a patient's health with impunity, all while undermining the patient-physician relationship. the pharmaceutical company is allowed to reap the financial benefits ofdtc adver­ tising while physicians and patients are left to bear both the financial and per­ sonal burdens of such actions.134 maintaining the current liability situation is untenable and must change. when faced with fhllure to warn cases involving dtc advertising, courts should acknowledge the need for an exception to the lid or, at the very least, properly investigate whether the physician actually functioned as a learned intermediary in the case at band. the possibility of im­ posing fiduciary obligations on the pharmaceutical company that advertises should be explored. 132. see perez v. wyeth laboratories inc., 734 a.2d 1245, 1262-63 (n.j. 1999) (stat­ ing, "in the case of direct marketing of drugs, we believe that neither the physician nor the manufacturer should be entirely relieved of their respective duties to warn."). 133. see foreman, supra note 79, at 117 (suggesting a case by case approach to deter­ mine whether the ud should be applied). 134. see west virginia ex rei. johnson & johnson corp. v. karl, 647 s.e.2d 899, 913 (w.va. 2007) ("[b]ecause it is the prescription drug manufacturers who benefit financially from the sales of prescription drugs and possess the knowledge regarding potential harms, and the ultimate consumers who bear the significant health risks of using those drugs, it is not unreasonable that prescription drug manufacturers should provide appropriate warnings to the ultimate users of their products."). health care quality reporting: a failed form of mandated disclosure? kristin madison* i. the failures of mandated disclosure .................... 315 a. the troubles of mandated disclosure ..................... 315 b. the troubles of quality reporting ........................... 317 c. the need to look beyond the troubles ................... 319 ii. the goals of mandated disclosure .............................. 321 a. failure to do what, exactly?: the goals of mandated disclosure ...................................................... 321 b. the goals of quality reporting ................................ 326 c. the benefits of quality reporting ........................... 329 iii. the costs of mandated disclosure ....................... 333 a. the many costs of mandated disclosure ............... 334 b. the costs of quality reporting ............................... 335 c. the marginal costs of quality reporting ................ 338 iv. alternatives to mandated disclosure.................. 340 a. voluntary reporting as an alternative to andatory quality reporting ........................................... 340 b. direct regulation as an alternative to mandatory quality reporting ........................................................... 343 v. conclusion ................................................................. 345 when i received an invitation to participate in a symposium sponsored by the hall center for law and health and the indiana health law review, i was delighted to discover that it would include a decision-making and transparency panel. having written numerous articles discussing law and policy issues related to health care quality reporting,1 it seemed obvious that my role on the panel *professor of law & health sciences, northeastern university. 1 see, e.g., kristin madison, regulating health care quality in an information age, 40 u.c. davis l. rev. 1577 (2007); kristin madison, the law and policy of health care quality reporting, 31 campbell l. rev. 215 (2009) [hereinafter, quality reporting]; kristin madison, legal & http://dx.doi.org/10.18060/3911.0018 2016 311 health care quality reporting: a failed form of mandated disclosure? should be to comment on the influence of quality metrics on patient decision-making. just two years before, i had published an article that discussed recent trends in health care quality measurement and reporting and offered an optimistic view of how these trends might benefit patients in the future.2 the symposium would offer an opportunity to further expand on these thoughts. but the official symposium topic, “medical myths,” seemed to point in a different direction. if the goal of the symposium was to encourage challenges to commonly held beliefs, then perhaps i should re-examine my own. a critical examination of quality reporting as a policy tool seemed particularly appropriate in light of a provocative article3 and related recently-published book4 proclaiming the failure of mandated disclosure. surveying the vast landscape of mandated disclosure policies, professors omri ben-shahar and carl e. schneider acknowledge that “mandated disclosure addresses a real problem and rests on a plausible assumption,” but argue that “it chronically fails to accomplish its purpose” and that “[e]ven where it seems to succeed, its costs in money, effort, and time generally swamp its benefits.”5 quality reporting is one of the many types of disclosure mandates the authors scrutinize. consumerdirected health care, for example, is a “bounteous fount of mandated disclosure” because it depends on access to reliable information about cost and quality.6 provider report cards are discussed in an article section entitled “the failures of other mandated disclosures.”7 the claim that mandated disclosure is a failure calls into question policy makers’ long-standing commitment to public policy issues in measuring and improving quality, in the oxford handbook of u.s. healthcare law (i. glenn cohen, allison k. hoffman & william m. sage eds., march 2016). 2 kristin madison, donabedian's legacy: the future of health care quality law & policy, 10 ind. health l. rev. 325 (2013). 3 omri ben-shahar & carl e. schneider, the failure of mandated disclosure, 159 u. pa. l. rev. 647 (2011). 4 omri ben-shahar & carl e. schneider, more than you wanted to know: the failure of mandated disclosure (2014). 5 ben-shahar & schneider supra note 3, at 651. 6 id. at 661. 7 id. at 672-74. http://dx.doi.org/10.1515/9781400850389 312 indiana health law review vol. 13:2 reporting of provider quality. was pennsylvania's 1986 legislation mandating extensive quality reporting pointless or even harmful?8 was the federal government's 2005 release of hospital quality ratings a waste of time?9 was a 2015 center for medicare and medicaid services press release announcing an expansion of quality reporting initiatives clearly mistaken when it stated "[t]his large release of quality measures for hospitals and physicians empowers consumers with information to make more informed health care decisions, encourages health care professionals to strive for higher levels of quality, and drives overall health system improvement?"10 should we abandon the federal website that reveals how often hospital nurses communicated well11 and how often surgery patients were given antibiotics at the right time?12 should the federal government decline to publish information about hospital heart attack patient mortality,13 nursing home deficiencies,14 and nursing home staffing?15 it is not entirely clear how ben-shahar and schneider would answer these questions. on one hand, their analysis leaves room for the possibility that quality reporting yields benefits. while emphasizing that mandated disclosure 8 kristin m. madison, from hcqia to the aca: the evolution of reporting as a quality improvement tool, 33 j. legal med. 63, 73-74 (2012). 9 id. at 79. 10 press release, ctrs. for medicare & medicaid servs., cms expands quality data on physician compare and hospital compare to help consumers choose health care providers (dec. 10, 2015) available at https://www.cms.gov/newsroom/mediareleasedatabase/press-releases/ 2015-press-releases-items/2015-12-10.html [https://perma.cc/7ggu2kl7]. 11 what information can i get about hospitals?, medicare.gov, https://www.medicare.gov/hospitalcompare/about/hospital-info.html [https://perma.cc/h93e-k8jk] (last visited may 26, 2016). 12 id. 13 id. readmissions and deaths, medicare.gov https:// www.medicare.gov/hospitalcompare/about/rcd.html [https://perma.cc/ 55um-xbn8] (last visited may 26, 2016). 14 what information can i get about nursing homes?, medicare.gov, https://www.medicare.gov/nursinghomecompare/ about/nursing-home-info.html. [https://perma.cc/5rnw-pyl4] (last visited mar. 3, 2016). 15 id. http://dx.doi.org/10.1080/01947648.2012.657600 2016 313 health care quality reporting: a failed form of mandated disclosure? “routinely fails,” they say that it is not doomed to do so,16 that “[m]any studies show some improvements” in disclosees' understanding, and that they have “never argued . . . that all disclosures fail.”17 in the context of report cards, ben-shahar and schneider acknowledge the existence of “evidence of some success in using disclosures to help people identify superior hospital care.”18 on the other hand, frequent health care examples illustrate the many limitations and pitfalls of quality reporting as a policy tool. the authors note that many people do not use report card information.19 they reference studies that suggest that quality report cards may produce harmful gaming and ultimately reduce welfare.20 the skepticism inherent in their thesis could easily extend to quality reporting. so should i temper my past optimism about reporting's potential effects? at the risk of being called a “disclosurite,” a label ben-shahar and schneider apply to commentators who favor disclosure,21 i remain guardedly optimistic. their work imparts valuable lessons and certainly offers food for thought for disclosurites of all sorts. the book's sensible arguments and voluminous evidence cutting across a broad range of regulatory areas should lead readers to question the advisability of mandated disclosure as a regulatory strategy. at the same time, however, the broad sweep of their work constrains their ability to offer comprehensive assessments of the advisability of particular disclosure policies, leaving readers to wonder whether there are exceptions to the authors' general claim, and if so, what form they might take. in this essay, i explore the possibility that quality reporting might be just such an exception. i find cause for optimism, in that evidence suggests quality reporting can make a difference. at the same time, however, the exercise reveals just how difficult assessing the success of a particular mandate can be. 16 ben-shahar & schneider, supra note 4, at 6. 17 id. at 47, 118. 18 id. at 52. they are also mindful of the possibility that health plans could make good use of report cards; they characterize disclosure to intermediaries as “more sensible than the present system.” id. at 188. 19 id. at 64-65. 20 id. at 52-53. 21 id. at 6. 314 indiana health law review vol. 13:2 part i of this essay explains why ben-shahar and schneider believe that mandated disclosure fails. after conceding that health care quality reporting suffers from many of the problems they have identified, part i explains why a closer look at the potential impact of health care quality reporting is nonetheless required. part ii considers the purposes and potential benefits of mandated disclosure. at various points in their book, benshahar and schneider offer a quite narrow view of the objectives that disclosure mandates are intended to achieve. in some cases, this view may accurately capture regulators' goals. part ii argues, however, that the policy objectives of governmental quality reporting initiatives are significantly broader than the goal at the heart of ben-shahar's and schneider's analysis. as professor richard craswell has pointed out,22 a multiplicity of goals will inevitably complicate efforts to assess whether a disclosure mandate has succeeded or failed.23 part iii examines the costs of mandated disclosure, including both the financial costs of complying with mandates and the costs associated with mandates' unintended effects. it finds that the costs of quality reporting are conceptually challenging to assess because these costs also support other benefit-producing activities. part iii therefore emphasizes the importance of thinking about costs and benefits of disclosure mandates against the backdrop of a broader and ever-changing group of policy interventions. part iv briefly considers the question that ben-shahar and schneider leave for the last chapter of their book: what should replace mandated disclosure? they describe ways in which information could reach marketplaces even in the absence of disclosure mandates. they also contemplate the possibility of command-and-control forms of regulation. the points they make are good ones. however, an attempt to apply their analysis to the context of quality reporting shows that the issues involved may be more complex than they first appear. 22 richard craswell, static versus dynamic disclosures, and how not to judge their success or failure, 88 wash. l. rev. 333, 337-40 (2013). 23 id. 2016 315 health care quality reporting: a failed form of mandated disclosure? part v concludes by calling for the development of a framework that lays out key characteristics of disclosure mandates and the environments in which they operate, so that we can develop a better understanding of the characteristics associated with mandate success. i. the failures of mandated disclosure in their book, more than you wanted to know: the failure of mandated disclosure, professors omri benshahar and carl e. schneider describe many situations in which individuals or entities are legally obligated to disclose some kind of information.24 lenders must provide information about their loans to prospective borrowers; physicians must provide information about treatments to patients; food manufacturers must provide nutrition information; and the list goes on.25 policy makers clearly believe that disclosure mandates can provide some kind of benefit (more on this in part ii). the book's title suggests, however, that mandated disclosure fails. in this part, i describe the reasoning underlying this claim, and show that many of the troubles that ben-shahar and schneider identify do indeed plague health care quality reporting mandates. i nevertheless argue that it may not be appropriate to classify quality reporting mandates as a “failure,” and explain why further analysis is required. a. the troubles of mandated disclosure ben-shahar and schneider lay out their basic claim in the introduction to their book. it is not a claim based on their own empirical research on the effects of the myriad mandates they describe. instead, they present an argument based on their conception of how disclosure requirements are created and implemented and how the information that flows from requirements is used (or not used): “[m]andated disclosure fails because it depends on a long chain of fragile links. it works only if three actors – lawmakers, disclosers, and 24 see ben-shahar & schneider, supra note 4. 25 see id. at 3-32 (discussing many types of disclosures). 316 indiana health law review vol. 13:2 disclosees – play demanding parts deftly.”26 disclosure requirements must be well-crafted to solve problems that policy makers have accurately diagnosed.27 in disclosing data, disclosers must act in ways fully consistent with the well-crafted requirements.28 and disclosees must review and fully understand the information provided in order to act appropriately in response to it.29 the argument is essentially that broken links lead to failed disclosure. ultimately, “mandated disclosure seems plausible only on logically reasonable but humanly false assumptions.”30 ben-shahar and schneider support their argument with citations to many studies that provide empirical evidence of broken links.31 the authors argue, for example, that individuals are often reluctant to make their own decisions, and may see little value in an extended deliberative process.32 studies show that consumers may devote little time to making a decision, and may reach a decision without making use of available information.33 studies documenting limited levels of literacy and numeracy give reason to doubt that people will understand disclosures. studies of particular forms of disclosure confirm that such doubts are justified;34 people may "misperceive, misinterpret, and misuse" disclosures.35 information overload may undermine decision-making.36 furthermore, putting information to good use may require background information that people lack.37 studies provide many examples of ways that bounded rationality can lead to poor decision-making.38 26 id. at 7. 27 id. 28 id. 29 id. at 8-11. 30 id. at 10. 31 see craswell, supra note 22, at 351-54 for a description and critique of ben-shahar's and schneider's analytical approach. 32 ben-shahar & schneider, supra note 4, at 62-64 (reluctance to make decisions); 70-77 (reasons people may choose not to make use of disclosures). 33 id. at 64-70. 34 id. at 80-86. 35 id. at 112. 36 id. at 104-106. 37 id. at 86-91. 38 id. at 110-12. 2016 317 health care quality reporting: a failed form of mandated disclosure? moreover, disclosures may unduly focus attention in one area, leading disclosees to neglect other areas that may also be important to their decision.39 and disclosers may respond in kind, acting in ways that make their mandated disclosures look good, but allowing their performance to deteriorate in areas that are not subject to reporting.40 reporting can lead to changes in behavior that make some intended beneficiaries of the disclosure mandate worse off.41 b. the troubles of quality reporting many of the troubles that ben-shahar and schneider aptly describe regularly arise in the world of quality reporting. indeed, the authors use a number of report cardrelated studies to support their analysis. for example, they cite a study for its finding that relatively few patients sought out comparative information or even considered alternative providers of surgical services.42 they cite a study that found that nursing homes improved in areas documented by report cards, but performed less well in other areas.43 they cite a classic study showing that when hospital cardiac care report cards were implemented, sicker patients ended up worse off.44 this study points to the possibility that entities seeking high scores may alter their conduct in ways that ultimately worsen patient care. these are just a few of many studies of health care quality reporting that should caution any policy maker or policy analyst who favors quality reporting as a policy strategy. many patients remain unaware of quality differentials or believe that their current provider is of high quality, so are 39 id. at 175. 40 id. at 176. 41 id. at 179-80; id. at 52-53. 42 id. at 65, citing lisa m. schwartz et al., how do elderly patients decide where to go for major surgery?, 331 bmj 821 (2005). 43 id. at 176, citing susan feng lu, multitasking, information disclosures and product quality: evidence from nursing homes, 21 j. econ. mgmt. strategy 673 (2012). 44 id. at 179-80 (citing david dranove et al., is more information better? the effects of "report cards" on health care providers, 111 j. pol. econ. 555 (2003)). http://dx.doi.org/10.1136/bmj.38614.449016.de http://dx.doi.org/10.1111/j.1530-9134.2012.00341.x http://dx.doi.org/10.1086/374180 318 indiana health law review vol. 13:2 not motivated to seek out quality report cards.45 recent studies show that relatively few patients consult ratings. a 2012 survey of internet users found that about 17% had consulted online rankings or reviews of doctors or other providers, while about 14% had consulted rankings or reviews of hospitals or medical facilities.46 a 2015 poll found that 10% of respondents had seen comparative quality information about doctors in the past year, and about 61% of those individuals had used it. about 13% had seen such information about hospitals, and about 35% of those individuals had used it.47 there are also studies showing that individuals may misinterpret information on report cards.48 the federal websites’ move toward using quality “stars” and other simplified presentations of data is an acknowledgment of the overly complex nature of previous presentation formats.49 and information overload continues to be a problem, although it is not necessarily inherent to government quality reporting mandates. the main problem instead arises from the many competing and sometimes conflicting sources of quality information available through many different websites.50 as i have discussed elsewhere, there are also plenty of troubles associated with the content of report cards.51 45 see quality reporting, supra note 1, at 227. 46 susannah fox & maeve duggan, health online (2013), available at http://www.pewinternet.org/~/media//files/reports/pip_healthonline .pdf [https://perma.cc/9c8l-prxj]. 47 kaiser health tracking poll: april 2015, kaiser family found. 1213 (apr. 2015), http://files.kff.org/attachment/topline-methodologykaiser-health-policy-news-index-april-2015 [https://perma.cc/6fyt47d9]. 48 see quality reporting, supra note 1, at 227, and sources cited therein (exploring difficulties in report card interpretation). 49 see home health star ratings, cms.gov, https://www.cms.gov/ medicare/quality-initiatives-patient-assessment-instruments/ homehealthqualityinits/hhqihomehealthstarratings.html [https:// perma.cc/f5av-pudq] (last visited may 26, 2016) (explaining reasons for addition of star ratings). 50 see, e.g., michael b. rothberg et al., choosing the best hospital: the limitations of public quality reporting, 27 health aff. 1680 (2008), available at http://content.healthaffairs.org/content/27/6/ 1680.full.pdf+html [https://perma.cc/em3r-7ys5]. 51 see quality reporting, supra note 1, at 227-36. http://dx.doi.org/10.1377/hlthaff.27.6.1680 2016 319 health care quality reporting: a failed form of mandated disclosure? measure selection is often driven by data availability and other practical considerations, which means that the quality measures reported may not provide the information that consumers care about most. problems with measure design and data collection can mean that measures fail to reflect true quality. while consumers may be interested in data about individual physicians, the relatively limited number of patients each physician sees presents significant statistical challenges for quality measurement.. commentators regularly highlight the difficulties in providing accurate information about provider quality.52 c. the need to look beyond the troubles commentators have pointed out the numerous flaws in quality reporting for many years,53 and calls to improve upon quality measurement and reporting initiatives are frequent.54 despite all of these shortcomings, however, i still cling to the possibility that mandated quality reporting might not be a failure. i confess that my optimism is driven in part by an intuition that ben-shahar and schneider contest: that the somewhat flawed data produced through mandates is better than no data or the bad data that might otherwise fill the information void. it is mostly driven, however, by the belief that some users value the data, coupled with the knowledge 52 see, e.g., steven findlay, health policy brief: physician compare, health aff. (oct. 29, 2015), available at http://healthaffairs.org/ healthpolicybriefs/brief_pdfs/healthpolicybrief_146.pdf [https://perma.cc/ c3x9-n5nl] (describing the challenges in developing the federal physician rating website); lisa rosenbaum, scoring no goal – further adventures in transparency, 373 new eng. j. med. 1385 (2015), available at http://www.nejm.org/doi/pdf/10.1056/nejmp1510094 [https://perma.cc/48yw-2z49] (describing statistical limitations involved in assessing physician quality). 53 see, e.g., timothy stoltzfus jost, oversight of the quality of medical care: regulation, management, or the market?, 37 ariz. l. rev. 825, 851-55 (1995) (discussing challenges of creating well-structured report cards). 54 see, e.g., elizabeth a. mcglynn & john l. adams, what makes a good quality measure?, 312 jama 1517 (2014) (calling for creation of “a clear framework and expectations for the intended goals of quality measures”). http://dx.doi.org/10.1056/nejmp1510094 http://dx.doi.org/10.1001/jama.2014.12819 320 indiana health law review vol. 13:2 that quality reporting can sometimes make a difference. more than half of the respondents to a 2015 survey indicated that “[m]aking information comparing the quality of health care provided by doctors and hospitals more available to patients” was a “top priority.”55 health affairs articles that have caught my eye include public reporting drove quality gains at nursing homes56 and public reporting helped drive quality improvement in outpatient diabetes care among wisconsin physician groups.57 other articles with less descriptive titles also suggest that report cards may influence health care delivery.58 perhaps i am overly optimistic about reporting's potential. given my previous work in this area, i may suffer from confirmation bias. i may accord too much weight to studies finding that report cards have an effect, particularly if journals are more inclined to publish studies showing statistically significant results. but studies like these do give me reason to believe that mandated reporting could at least potentially benefit patients, which raises the question: does it? or, to be more precise, do the benefits associated with mandated quality reporting exceed its costs? in their book, ben-shahar and schneider seem to call for investigation of this very question: “[t]he harmlessness hypothesis needs to go; the cost-benefit analysis that has become a norm for regulation should come.”59 they do not undertake such an analysis in their book, however. perhaps they decline to follow through on their suggestion because the broad scope of the book does not allow for detailed 55 kaiser health tracking poll topline: april 2015, kaiser family found. 6 (apr. 2015), http://files.kff.org/attachment/toplinemethodology-kaiser-health-policy-news-index-april-2015. [https:// perma.cc/nf55-7x2z]. 56 rachel werner et al., public reporting drove quality gains at nursing homes, 29 health aff. 1706 (2010). 57 maureen a. smith et al., public reporting helped drive quality improvement in outpatient diabetes care among wisconsin physician groups, 31 health aff. 570 (2012). 58 see, e.g., m. kate bundorf et al., do markets respond to quality information? the case of fertility clinics, 28 j. health econ. 718 (2009); justin wang et al., do bad report cards have consequences? impacts of publicly reported provider quality information on the cabg market in pennsylvania, 30 j. health econ. 392 (2011). 59 ben-shahar & schneider, supra note 4, at 182. http://dx.doi.org/10.1377/hlthaff.2009.0556 http://dx.doi.org/10.1377/hlthaff.2011.0853 http://dx.doi.org/10.1016/j.jhealeco.2009.01.001 http://dx.doi.org/10.1016/j.jhealeco.2010.11.006 2016 321 health care quality reporting: a failed form of mandated disclosure? examinations of particular areas of disclosure. or perhaps they believe that the gains from disclosure are so low, and the costs so high, that careful analysis is not needed to conclude that mandated disclosure is a failure. or perhaps a full cost-benefit analysis is just not feasible, given the current state of the data. but even if the data proves to be lacking, a preliminary investigation could help clarify the issues to be addressed in a fuller analysis. in the remainder of this essay, i will describe key benefits and costs of mandated reporting, and explain why i am not yet convinced that mandated quality reporting is a failure, despite all of its troubles. ii. the goals of mandated disclosure to determine whether any mandate has succeeded or failed, it is important to first clarify what the mandate intended to achieve. in the words of professor craswell, "we cannot evaluate the success or failure of any disclosure law without considering the possible goals that law might have had."60 while professors ben-shahar and schneider acknowledge many potential benefits of properly functioning disclosure laws, much of their analysis implies that policy makers' typical goal in enacting disclosure laws is fully informed decision-making by disclosees. this part argues that while informed decision-making is surely one goal of quality reporting mandates, it is not the only one, and that any assessment of the impact of quality reporting should take this reality into account. a. failure to do what, exactly?: the goals of mandated disclosure at one level, the goal of mandated disclosure laws is obvious: it is to ensure the availability of the mandated information. but to what end? professors ben-shahar and schneider offer one possible answer in the introduction to their book: mandated disclosure “aspires to help people making unfamiliar and complex decisions while dealing with specialists by requiring 60 craswell, supra note 22, at 334. 322 indiana health law review vol. 13:2 the latter (disclosers) to give the former (disclosees) information so that disclosees choose sensibly and disclosers do not abuse their position.”61 this framing of the issues focuses on the informational advantage that disclosers possess, the possibility that disclosers might exploit this advantage, and the desire to ensure that disclosees make decisions that make sense. other comments in the book focus more on informing choice than on forestalling exploitation, although clearly the concepts are related. in describing how the success of a disclosure mandate might be assessed, benshahar and schneider provide a number of citations that support a view that the “conventional disclosurite understanding” is that a successful mandate will “provid[e] information that equips disclosees to understand their choice well enough that they analyze it and make a well-informed, well-considered decision.”62 they suggest that disclosurites often look for “full disclosure.”63 passages scattered throughout the book provide a more nuanced look at the goals of mandated disclosure laws, as illustrated by the writings of a variety of authors. these alternative descriptions of the functions and aims of disclosure mandates are not necessarily inconsistent with an overarching goal of well-considered decisions (or sensible choices). they do, however, focus on different ways that information may be relevant to the decision-making process. for example, in describing the goals of informed consent, ben-shahar and schneider mention the ideas of sovereignty, patient control, and autonomy, in addition to rationality.64 they subsequently make a connection between the “autonomy rationale” for disclosure and “dignity,” and note that “[s]ome disclosurites believe that giving people disclosures honors disclosees' autonomy whatever its effect on their decisions.”65 in describing the varied functions of different types of mandates, they suggest that “[d]isclosures seek to facilitate, to persuade, and to educate," and that 61 ben-shahar & schneider, supra note 4, at 3. 62 id. at 34. 63 id. at 35. 64 id. at 34-35. 65 id. at 36. 2016 323 health care quality reporting: a failed form of mandated disclosure? "[s]ome disclosures seek more to persuade than inform.”66 later, in discussing requirements that drug companies disclose payments to physicians, they mention an aim of “accountability.”67 this short list of brief passages gives a sense of the considerable challenges of attempting to provide a global assessment of the impact of mandated disclosure laws. if the goal of mandated disclosure is ensuring autonomy, then the question is how much disclosure is necessary to ensure autonomy. if the goal is instead persuasion, then providing full information may not be necessary and may indeed be counterproductive. if the goal is accountability of the discloser, then the question becomes accountability to whom for what, and the focus of the analysis may begin to shift away from the details of the disclosee's decision-making process. the difficulties of assessing success become even clearer when examining particular mandates. everyone may agree that the point of nutrition labeling is to provide the information necessary for consumers to choose wisely. but what does this mean? choosing wisely could mean that consumers weigh the nutritional information along with the price of the food, the taste of the food, and a host of other characteristics in deciding what to eat. this would certainly be consistent with the authors' "well-considered" decisionmaking frame, an orientation toward full disclosure, and the views of many commentators. but the quote the book supplies suggests a different end goal: a reduction in mortality.68 full disclosure might be consistent with a mortality reduction goal, and well-considered decisions may help achieve the goal. an evaluation of whether labeling succeeds in reducing mortality might look quite different, however, from an evaluation of the impact labeling has on fullyinformed decision-making. for one thing, if the goals of policy makers and individual consumers do not align, then fully-informed decision-making will not yield the desired results. if consumers place a high value on a tasty diet, a 66 id. at 28, 30. 67 id. at 147. 68 see id. at 39 (quoting from another author's discussion of nutrition labeling). 324 indiana health law review vol. 13:2 study could show that consumers are perfectly informed but that the disclosure mandate is a “failure” from a policy perspective. more importantly, disclosure might reduce mortality even if it falls short of ensuring fully informed decision-making. labeling might lead to fully informed, wellconsidered decisions that alter consumption patterns and reduce mortality. but it might instead lead to more consumer focus on nutritional quality and somewhat more informed decision-making, which together prod manufacturers to reformulate their products, reducing mortality. in his essay, professor craswell highlights the importance of distinguishing between “static” and “dynamic” disclosures in assessing the success of disclosure mandates. the goal of a static disclosure is to “improve a consumer's choice from among the existing choice set,” while the goal of dynamic disclosures “is to improve the existing choice set by creating incentives for sellers to improve the quality of offerings.”69 craswell's analysis makes clear that the proper approach to assessment will depend on the nature and purpose of the disclosure. to evaluate the success of static disclosures, craswell suggests examining consumer beliefs; to evaluate the success of dynamic disclosures, craswell suggests a focus on the average quality of the product in the marketplace.70 it may be that one reasonable way of 69 craswell, supra note 22, at 334. under craswell's model, the goal of static disclosure is to bring the consumer's assessment of quality closer to the true quality, id. at 342, which in turn will ensure that the consumer purchases the right quantity of a particular brand. by contrast, the goal of dynamic disclosure is to “improve the mix of products that is available on the market.” sellers have a proper incentive to improve their product only if changes in consumers' assessment in quality are commensurate with sellers' actual improvement; the goal of dynamic disclosures is thus basically to ensure that sellers get full credit, nothing more, and nothing less, for their improvements. id. at 343-44. if disclosures achieve perfect information in the marketplace, they will serve both functions, id. at 344, but reality falls short of perfection. 70 craswell, supra note 22, at 345-350 (assessing static disclosures); id. at 354-72 (assessing dynamic disclosures). as an example of an assessment of dynamic disclosures, craswell suggests an examination of changes in the relative market shares of high-fat salad dressings and lowfat dressings. id. at 358-59. such changes in market share, however, could result from multiple phenomena. first, if most consumers would 2016 325 health care quality reporting: a failed form of mandated disclosure? evaluating the success of the informed consent process is by assessing patients' understanding of available treatment options; an evaluation of nutrition labeling may benefit from a different focus. in sum, professors ben-shahar and schneider highlight a view that the core goal of mandated disclosure is wellinformed, well-considered decisions, and demonstrate that prefer to avoid fat but cannot estimate fat content, leading them to buy too many high-fat dressings, ratings that correct misperceptions will increase their purchases of low-fat dressings, while higher-fat dressings remain on the shelf. second, if consumers accurately estimate fat content but usually ignore it, labeling could draw their attention to this attribute, a phenomenon that would also lead to more purchases of low-fat dressings. in both cases, product mix will change without any manufacturer intervention, although presumably lower levels of consumer demand would eventually lead them to shut down their highfat production lines. third, in anticipation of increased demand for lowfat products from better-informed or more motivated consumers, producers might reformulate all of their products to be lower in fat, thus increasing market share for low-fat products. even consumers who pay no attention to fat levels would end up buying low-fat dressings, further boosting low-fat market shares. a fourth possibility is that manufacturers will try to take advantage of consumer attention to salad dressings and their fat content by introducing new products in a way that both expands consumer choice sets and shifts market share toward lowfat products. i would argue that the first phenomenon seems consistent with craswell's static disclosure model, while the third is the closest match to the dynamic disclosure model; the second phenomenon seems outside both models, and i am not sure how the fourth is best conceptualized. the effects of all four phenomena, however, are dynamic in nature, since they will ultimately alter product mix in the marketplace. the difficulty of developing cleanly-defined categorizations of disclosure mechanisms and their effects is apparent in quality reporting as well. the theoretical literature on quality reporting talks about "selection" pathways, where quality increases because patients abandon low-quality providers in favor of higher quality providers, and "change" mechanisms, where quality increases because existing providers improve their own quality. see damien contandriopoulos, francois champagne & jean-louis denis, the multiple causal pathways between performance measures' use and effects, 71 med. care res. and rev. 3, 7 (2013) (discussing causal pathways). these scholars observe that “[f]rom a systemic perspective," these two pathways are not always cleanly distinguishable: "the reallocation of resources toward high performers and the eventual closure of underperforming units would probably be construed as change, while, from the perspective of individual units, it amounts to selection.” id. at 8. http://dx.doi.org/10.1177/1077558713496320 326 indiana health law review vol. 13:2 many commentators see full disclosure as ideal. their book also makes clear, however, that mandated disclosures vary quite widely in nature and content, and can encompass a broader set of functions and goals. in evaluating the success or failure of a disclosure mandate, it is important to consider the benefits that policy makers hope to achieve. b. the goals of quality reporting so what goals might a policy maker who mandates quality reporting seek to achieve, and what are the mechanisms by which reporting may achieve its goals? in a 2015 press release announcing an update to its health care quality report cards, the centers for medicare and medicaid services (cms) explicitly lays out multiple aims: “[t]his large release of quality measures for hospitals and physicians empowers consumers with information to make more informed health care decisions, encourages health care professionals to strive for higher levels of quality, and drives overall health system improvement.”71 the first aim, informed decision making, nicely illustrates the theme that professors ben-shahar and schneider emphasize. it is consistent with a general goal of ensuring patient autonomy. patients will be able to understand the choices facing them more clearly, and so may be able to make decisions consistent with their own goals. the cms formulation does not declare a goal of fully informed decisions, just more informed decisions, which perhaps serves as an implicit acknowledgment of the costs and/or impossibility of achieving a full information ideal. the second and third aim seem more in line with the dynamic effects that professor craswell emphasizes. cms asserts that quality reporting will alter the effort that providers devote to achieving health care quality; this could be described as an instrumental aim intended to achieve an ultimate goal of boosting quality. and “driv[ing] overall health system improvement” could be described as cms’ overall objective in implementing the quality reporting program.72 71 press release, ctrs. for medicare & medicaid servs, supra note 10. 72 id. 2016 327 health care quality reporting: a failed form of mandated disclosure? in theory, quality reporting programs could generate a number of desired effects that would culminate in “overall health system improvement.” first, the very existence of quality reporting could bring quality issues to consumers' attention. quality expert david eddy has suggested that historically, it was assumed that “through the rigors of medical education, followed by continuing education, journals, individual experiences, and exposure to colleagues, each physician always thought the right thoughts and did the right things.”73 if consumers believe that providers think the right thoughts and do the right things, there is little reason for them to seek quality-related information, even if they value quality highly. a survey suggests that many consumers do not believe there are “big differences” in quality across providers.74 if consumers believe that “big differences” are the only ones worth looking into, and if in fact there are differences that meet consumers' definitions of “big,” then the policy argument for focusing consumers' attention on quality is stronger. in such cases, quality reporting could result in more fully informed decision making that allows consumers to pursue their own quality-related aims. second, quality reporting could improve average levels of quality by redirecting the flow of patients to higher quality providers. patients could visit quality reporting websites and use the available information to select high-quality providers, a mechanism consistent with the basic model that ben-shahar and schneider present. for this mechanism to work, measures must be accurate and consumers must understand and appropriately act on them. alternatively, other entities could use the data provided in public quality reports to direct patients to higher-quality providers. for example, an insurer might exclude a poorlyrated provider from a network or provide a financial incentive to the patient to choose a more highly-rated provider. ben-shahar and schneider highlight the potential role that intermediaries might play in ensuring that 73 david m. eddy, evidence-based medicine: a unified approach, 24 health aff. 9, 9 (2005). 74 quality reporting, supra note 1, at 227 n.61. http://dx.doi.org/10.1377/hlthaff.24.1.9 328 indiana health law review vol. 13:2 consumers reap the benefit of disclosures, even in the absence of full information.75 third, quality reporting could improve average levels of quality by altering provider behavior. again, there are several possible mechanisms through which this effect could occur. one is competition: if patients seek matches to more highly-rated providers, and treating patients is profitable, then profit-seeking providers have reason to try to obtain higher ratings. note that this effect does not depend on the reason for which patients end up at the doorstep of more highly-related providers; all that matters is that they do (or, more precisely, that providers believe they will). another possible mechanism through which reporting could alter provider practices is reputation; physicians and hospitals may seek to be recognized for providing higher quality care.76 public reporting could potentially motivate such providers to do better, regardless of the financial consequences that follow from any changes they make. this mechanism requires that public reporting channel information to individuals or entities whose views providers care about; providers might worry about the views of their own patients, but they could also be motivated by information that flows to other providers or to the general public through reporting processes.77 some of these mechanisms require that patients review and understand data, but others do not. studying whether patients acquire, understand, and use data makes sense if 75 ben-shahar & schneider, supra note 4, at 188 (discussing intermediaries). 76 public reporting could also alter provider practice by supplying information about each provider's own performance as well as the performance of top providers. providers could use this information to identify areas in need of improvement, to identify other providers potentially worthy of emulation, and to track improvement in the aftermath of efforts to improve quality. i relegate these quality improvement mechanisms to the footnotes because it is mostly quality measurement and private reporting that are important for taking these steps, not public reporting. 77 a third, perhaps less likely mechanism, is that patients may place direct pressure on providers to improve quality. a patient aware of a provider's high infection rates might become especially vigilant about provider handwashing practices, for example. patients could also become more vigilant about their own handwashing practices, which could also result in better health outcomes. 2016 329 health care quality reporting: a failed form of mandated disclosure? one of the goals of information provision is patient autonomy; it also makes sense as an assessment of whether patientbased quality improvement mechanisms have any hope of succeeding. but other tests are also available to determine whether reporting mandates at least have the potential to succeed in improving quality; for example, studies could examine whether providers undertake efforts to improve quality in response to quality rating. and then there is the most direct route to studying whether reporting succeeds in driving improvement: examining the empirical relationship between reporting and quality. c. the benefits of quality reporting there are actually quite a few studies that have examined quality reporting. they vary considerably in the type of reporting examined, the time period considered, the methodology used, and the overall quality of the analysis. my goal in examining a few of these studies is not to provide a comprehensive review, but instead to convey a sense of the data on which an evaluation of the success or failure of reporting could be based. as discussed in part i.b, surveys suggest that some patients use quality data. these same surveys demonstrate, however, that many patients do not. according to the previously mentioned 2015 survey, about six percent of respondents used comparative quality data about physicians.78 if the goal is to improve patient autonomy or ensure well-informed decisions, is this finding an indication of success or failure? it's actually hard to say. some survey respondents might not have had a need for physician care, and so were never faced with a decision about the identity of their provider. such individuals should surely be excluded from an analysis of whether patients use quality information. others might have seen a provider, but never even considered the possibility of an alternative provider. it might be argued that these patients should be excluded too, since they did not view themselves as making a decision; alternatively, it might be argued that they should be included, on the grounds that it is important to consider 78 kaiser family foundation, supra note 46, at 13. 330 indiana health law review vol. 13:2 provider quality whenever an individual seeks treatment. furthermore, even if all individuals are included in the analysis, it could be argued that physician report cards succeeded because they were used by the six percent. there is no obvious place to draw a line between "success" and "failure" when examining a metric like this in isolation;79 what matters most is whether a reporting initiative achieves its ultimate goals. in short, a few patients actively use report cards, but only a few. if the expectation is that autonomy requires every patient to be fully informed about physician quality at every patient encounter, then reporting could be deemed a failure in this respect. in my view, however, this is not a reasonable standard, and, more importantly, quality improvement, not autonomy, is the primary goal of reporting. from a quality improvement perspective, data suggesting low report card use rates should temper expectations about the impact report cards can have through patient choice-based mechanisms. it is important to look beyond patient survey data, however, to assess the aggregate effect of report cards on care delivery. many studies have done just that.80 studies examining whether report cards channel patients to higher-quality providers have found mixed results with respect to a variety 79 see craswell, supra note 22, at 339, 348 (pointing out the indeterminacy of the line between success and failure). 80 see david dranove, health care markets, regulators, and certifiers, in 2 handbook of health econ. 639, 681 (mark v. pauly, thomas g. mcguire, & pedro pita barros eds., 2012) (summarizing empirical studies of report cards effects); constance h. fung et al., systematic review: the evidence that publishing patient care performance data improves quality of care, 148 annals internal med. 111 (2008) (providing a systematic review of quality report card studies); dana b. mukamel et al., top-down and bottom-up approaches to health care quality: the impacts of regulation and report cards, 35 ann. rev. pub. health 477, 486 (2014) (reviewing empirical studies of report cards from 2006 or later); agency for healthcare research and quality, executive summary, public reporting as a quality improvement strategy, closing the quality gap: revisiting the state of the science, evidence report no. 208 (2012), available at https:// effectivehealthcare.ahrq.gov/ehc/products/343/1198/evidencereport208_ cqg-publicreporting_executivesummary_20120724.pdf [https:// perma.cc/4t8l-nh2r] (summarizing results of multiple report card studies). http://dx.doi.org/10.1016/b978-0-444-53592-4.00010-4 http://dx.doi.org/10.7326/0003-4819-148-2-200801150-00006 http://dx.doi.org/10.1146/annurev-publhealth-082313-115826 2016 331 health care quality reporting: a failed form of mandated disclosure? of providers, including hospitals, physicians, and nursing homes. most of these studies do not examine the specific mechanisms for this selection effect, but instead the relationship between reporting and treatment by providers with high quality ratings. for example, one study found that voluntary california bypass surgery report cards increased volume at hospitals with low mortality,81 while another found that pennsylvania's mandated bypass surgery report cards reduced the patient volume of poorly rated surgeons.82 a study of report cards on fertility clinics found that clinics with higher birth rates obtained larger market shares after report card adoption.83 a study examining patient nursing home choice before and after the release of federal nursing home report cards found a statistically significant relationship between reported quality and nursing home choice, but the effect was quite small.84 a few studies looking at a variety of service types, report cards, and time periods failed to find an effect.85 given the quantity and quality of the studies that do find an effect, however, my conclusion is that it is likely that at least under some conditions, report cards can influence patients' choice of providers. recent hospital survey data suggests that providers respond to quality reporting initiatives. one study reports that “[f]or each of the mortality, readmission, process, and patient experience measures, more than 70% of hospitals agreed with the statement that ‘public reporting stimulates quality improvement activity at my institution.’”86 furthermore, “87.1% of hospitals reported incorporating performance on publicly reported measures into their hospital's annual goals, whereas 90.2% reported regularly 81 patrick s. romano et.al., impact of public reporting of coronary artery bypass graft surgery performance data on market share, mortality, and patient selection, 49 med. care 1118 (2011). 82 justin wang et al., supra note 58, at 392. 83 m. kate bundorf et al., supra note 58. 84 rachel m werner et al., do consumers respond to publicly reported quality information? evidence form nursing homes, 31 j. health econ. 50, 59 (2012). 85 see mukamel et al., supra note 81 at 486 (documenting studies). 86 peter k. lindenauer et al., attitudes of hospital leaders toward publicly reported measures of health care quality, 174 jama internal med. 1904, 1907 (2014). http://dx.doi.org/10.1097/mlr.0b013e3182358c78 http://dx.doi.org/10.1016/j.jhealeco.2012.01.001 http://dx.doi.org/10.1001/jamainternmed.2014.5161 332 indiana health law review vol. 13:2 reviewing the results with the hospital's board of trustees and 94.3% with senior clinical and administrative leaders.”87 the evidence that public reporting alters hospital behavior is quite robust; this recent evidence adds to a number of other studies that have documented hospitals’ responses to quality reporting.88 stimulating quality improvement activity, however, is only an intermediate goal of quality reporting; what matters is whether this activity translates into quality improvement. studies examining the relationship between report cards and quality have begun to accumulate. as is the case with provider selection studies, these studies do not generally try to isolate the mechanism by which reporting might have an effect, if indeed it does. findings of these quality studies are mixed, but many studies have found a relationship between reporting and quality, and recent studies seem to have been more likely to find an effect.89 for example, one empirical study used a differences-in-differences approach to compare treatment outcomes for pennsylvania hospital patients with those of patients treated at hospitals subject to less intensive or no public reporting; the authors concluded that reductions in mortality were associated with intensive public reporting.90 a very recent study using detailed clinical registry data to control for patient risk found that patients who underwent percutaneous coronary interventions (angioplasties) in states with mandated public reporting had lower mortality rates than patients in other states.91 another study found that for “two of three reported. . . 87 id. 88 see, e.g., mark r. chassin, achieving and sustaining improved quality: lessons from new york state and cardiac surgery, 21 health aff. 40 (2002); joanne m. hafner et al., the perceived impact of public reporting hospital performance data: interviews with hospital staff, 23 int'l j. for quality in health care 697 (2011); mukamel et al., supra note 81, at 487 (discussing recent quality improvement studies). 89 see mukamel et al., supra note 81, at 488 (providing broad overview of recent studies). 90 christopher s. hollenbeak et al., reductions in mortality associated with intensive public reporting of hospital outcomes, 23 am. j. med. quality 279 (2008). 91 matthew a. cavender et al., state mandated public reporting and outcomes of percutaneous coronary intervention in the united states, 115 am. j. cardiology 1494, 1499 (2015). http://dx.doi.org/10.1377/hlthaff.21.4.40 http://dx.doi.org/10.1093/intqhc/mzr056 http://dx.doi.org/10.1177/1062860608318451 http://dx.doi.org/10.1016/j.amjcard.2015.02.050 2016 333 health care quality reporting: a failed form of mandated disclosure? measures,” postacute care quality rose after the initiation of federal quality reporting.92 these studies do not establish that mandated quality reporting is the key to health care system improvement. relatively few studies have examined physician quality reporting. some studies, such as the postacute care study just described, find a relationship between reporting and some quality metrics, but not others. when studies do find an impact, its magnitude may be relatively small. for example, a study of federal hospital reporting found no reductions in mortality for heart attack and pneumonia, and only a "modest reduction" for heart failure.93 as with the empirical evidence on provider selection, the prevalence of studies finding a connection between reporting and quality metrics suggests that reporting can make a difference, and so mandated quality reporting is not a failure in that sense. the universe of studies leaves open questions about how much of a difference, and the conditions under which report cards are most likely to succeed. understanding the magnitude of quality benefits (as well as any benefits associated with autonomy or other aims) is important, given the costs associated with reporting. iii. the costs of mandated disclosure as part ii makes clear, there has been significant effort devoted to thinking about the potential benefits of mandated disclosure, including in the context of quality reporting. this focus makes sense; there is no reason to pursue any regulatory initiative, including reporting mandates, if it yields no cognizable benefits. but if reporting initiatives plausibly meet that threshold, then the next question must be whether the benefits exceed the costs. there seem to be many fewer studies focusing on the costs of disclosure. some kinds of costs are difficult to calculate for conceptual reasons; 92 rachel m. werner et al., impact of public reporting on quality of postacute care, 44 health servs. res. 1169, 1169 (2009). 93 andrew m. ryan et. al., medicare's public reporting initiative on hospital quality had modest or no impact on mortality from three key conditions, 31 health aff. 585, 588-90 (2012) (finding in an analysis adjusted for patient characteristics and time trends, a .97 relative risk ratio for heart failure-related mortality). http://dx.doi.org/10.1111/j.1475-6773.2009.00967.x http://dx.doi.org/10.1377/hlthaff.2011.0719 334 indiana health law review vol. 13:2 other kinds of costs are more straightforward, but are not as accessible to researchers as the kinds of data used for part ii's studies. nevertheless, it is important to at least acknowledge the costs associated with disclosure mandates, including quality reporting. a. the many costs of mandated disclosure in a chapter entitled, “at worst, harmless?,” professors ben-shahar and schneider describe harms that could arise from mandated disclosure. there are many, and they are right to remind disclosure advocates that the costs of disclosure mandates are real, just as they are for other types of mandates. for the regulated entity, costs include those associated with collecting data, preparing disclosure content, disseminating information, and possibly documenting the provision and receipt of the disclosure.94 disclosees' costs include the costs associated with reading disclosures.95 i would add that the regulators who design and enforce disclosure mandates may also devote considerable resources to this effort. but ben-shahar and schneider also recognize that costs extend far beyond those associated with creating and implementing a mandate. they explain that “mandates can undercut other regulation, deter lawmakers from adopting better regulation, impair decisions, injure markets, exacerbate inequality, and in some important cases, cripple valuable enterprises.”96 while all of these effects are illustrated with examples, some seem more broadly applicable than others; i will focus on a few potential costs that seem to have special relevance to quality reporting. one such cost is “impair[ed] decisions.” ben-shahar and schneider note that information supplied could be wrong or direct disclosees’ attention away from other things that matter; an overabundance of information could obscure the points that matter most and undermine the value of reporting.97 another cost is directing disclosers’ attention 94 ben-shahar & schneider, supra note 4, at 169-70. 95 id. at 170. 96 id. at 169. 97 id. at 175-76. 2016 335 health care quality reporting: a failed form of mandated disclosure? away from other things that might matter, but are not subject to reporting. ben-shahar and schneider classify this cost as “making markets worse.”98 a third cost is “exacerbating inequality,” which can occur if the costs of disclosure mandates are borne by all, but it is the besteducated and, in some cases, the most economically advantaged, who are best positioned to make full use of them.99 b. the costs of quality reporting the costs associated with mandated health care quality reporting are significant. while the costs of disclosing relevant data are not likely to be especially high in this age of web-based data dissemination, the costs of collecting and reporting the required data can be large. to get a sense of these costs, consider a recent study of cardiology, orthopedics, primary care, and multispecialty practices that concluded that united states physician practices collectively spend more than $15.4 billion per year on quality reporting.100 or consider the 2015 final rule addressing medicare's hospital inpatient quality reporting program.101 the regulatory impact analysis indicates that by removing certain measures from the previous reporting program, the final rule will reduce the “burden associated with the collection of chart-abstracted data.”102 how much? it estimates that removing nine measures will reduce the total burden across all hospitals by 741,000 hours.103 the analysis also estimates that for each of the 3,300 hospitals impacted, the “burden per hospital for previously finalized requirements” was 1,135 hours for “chart-abstracted and 98 id. at 176. 99 id. at 178-80. 100 lawrence p. casalino et al., u.s. physician practices spend more than $15.4 billion annually to report quality measures, 35 health aff. 401, 401 (2016) (summarizing results), id. at 402 (describing groups surveyed). 101 medicare program, 80 fed. reg. 49,326 (aug. 17, 2015) (to be codified at 42 c.f.r. pt. 412). 102 id. at 49,837. 103 id. http://dx.doi.org/10.1377/hlthaff.2015.1258 336 indiana health law review vol. 13:2 structural measures, forms” and “review[ing] reports for claims-based measures.”104 quality reporting also implicates many of the other kinds of costs on the list offered by ben-shahar and schneider. the risk that poorly-executed report cards could mislead users is real. the data underlying report card metrics could be incorrect, or the metrics themselves could be poor reflections of true quality. correct metrics could be misinterpreted or misused; for example, findings of one study suggested that giving patients information about provider cost in the hope of promoting high-value care could yield unexpected results, because some patients equate higher cost with higher quality.105 the provision of ratings related to some dimensions of quality, but not others, could lead patients to unduly focus on those dimensions in making their decisions. patients checking out medicare's hospital comparison site by clicking through the tabs presenting different types of quality ratings will first see ratings based on patients' experiences; if they do not click through the rest of the tabs, they may not take into account clinical quality measures such as complication rates or mortality in making their decisions.106 even if patients make good use of report cards, the incentive effects associated with quality reporting could make care worse. ben-shahar and schneider cite research suggesting that nursing homes performed better on measures captured in public reporting, but did worse on others;107 if providers neglect unmeasured areas, average quality may go down, and quality metrics could mislead report card users. poorly-constructed measures can have unintended consequences; a metric designed to capture the prompt administration of antibiotics for pneumonia was 104 id. at 49,838. 105 judith h. hibbard et al., an experiment shows that a welldesigned report on costs and quality can help consumers choose high-value health care, 31 health aff. 560, 565-66 (2012), available at http://content.healthaffairs.org/content/31/3/560.full.pdf+html [https:// perma.cc/fl3j-74he] (showing also that altering presentation format and the quality signal provided could help address this problem). 106 hospital compare, medicare.gov, https://www.medicare.gov/ hospitalcompare/search.html [https://perma.cc/u88c-3n2v] (last visited may 26, 2016). 107 ben-shahar & schneider, supra note 4, at 176. http://dx.doi.org/10.1377/hlthaff.2011.1168 2016 337 health care quality reporting: a failed form of mandated disclosure? revised after its time constraints put pressure on providers to supply antibiotics to patients whose diagnosis was not yet confirmed.108 quality reporting can also lead to gaming that can lower quality for patients and potentially exacerbate inequalities. one study found that when new york and pennsylvania implemented their cardiac surgery reporting systems, the average severity of illness of patients receiving bypass surgery went down, suggesting that physicians were turning away sicker patients. 109 while the results indicated that sicker patients were more likely to be matched with teaching hospitals, the adoption of report cards was associated with poorer outcomes overall, including for sicker patients.110 another study found that the release of new york's bypass surgery report card was associated with increased racial and ethnic disparities in the receipt of cardiac care.111 this could occur if physicians are concerned that members of racial or ethnic minority populations might be at a “higher risk for poor outcomes” in ways that quality metrics fail to capture, thus inappropriately worsening outcomes measures.112 quality ratings could also increase disparities if one group is more likely to see, understand, and properly use quality ratings than another. for example, if more educated individuals have both better underlying health and a stronger tendency to use report cards well, then educationbased disparities may begin to increase. note, however, that this kind of effect depends on both treatment patterns in the absence of report cards and on the identity of report card users. if the most educated patients already acquire quality information through other sources, then it may be less educated patients whose behavior is most impacted by report cards. 108 see robert m. wachter et al., public reporting of antibiotic timing in patients with pneumonia: lessons from a flawed performance measure, 149 annals internal med. 29, 29 (2008). 109 dranove et al., supra note 43, at 570, 582-84. 110 id. 111 rachel m. werner, david a. asch & daniel polsky, racial profiling: the unintended consequences of coronary artery bypass graft report cards, 111 circulation 1257, 1257 (2005). 112 id. http://dx.doi.org/10.7326/0003-4819-149-1-200807010-00007 http://dx.doi.org/10.1161/01.cir.0000157729.59754.09 338 indiana health law review vol. 13:2 there are plenty of reasons to believe that the costs discussed in this section are “real," and evidence points to the existence of some types of costs. evidence is sparser for other types, however, and many of the costs are difficult to quantify, increasing the challenges of a full analysis of the net impact of reporting. note that even if studies show that these costs exist, there are ways to limit them. as electronic health records spread and improve, data collection costs should go down. reporting refinements and other interventions can also reduce the costs of reporting. researchers have identified ways to increase the likelihood that users understand the information presented.113 gaming is always a possibility, but revising outcomes metrics to capture the risks that most concern physicians may reduce the opportunity for gaming. thus, while using current evidence to assess costs is an important first step in analyzing the impact of reporting initiatives, it is also important to consider the likelihood of future changes that might affect those costs. the same observation could be made about an analysis of reporting's benefits. c. the marginal costs of quality reporting one other complication in evaluating the impact of quality reporting is that the infrastructure necessary to comply with government reporting mandates may yield other benefits. many of the financial costs associated with reporting are not actually the costs of reporting; they are the costs of data collection and measurement. these costs could be viewed as an investment supporting a range of provider activities. for example, a health care provider may want to track a variety of quality metrics in an effort to improve its own health care quality, without regard to the existence of any mandated reporting program. third parties with an interest in monitoring quality may seek access to quality metrics, regardless of whether the metrics are also publicly reported. private and public payers may choose to incorporate quality 113 see hibbard, supra note 105 (discussing effects of changing report card and format). 2016 339 health care quality reporting: a failed form of mandated disclosure? metrics into their payment formulas.114 if an accountable care organization must report a series of quality metrics in order to receive payments under the federal shared savings program, then the marginal financial costs associated with public reporting of the same metrics will be small.115 in the current environment, many provider organizations would face significant data collection and measurement costs even in the absence of a public reporting program. the marginal costs of a disclosure mandate would therefore be quite low, strengthening the justification for quality reporting requirements. at the same time, however, the existence of these other uses of quality data might also affect the marginal benefits of a reporting mandate. if pay-for-performance payment regimes are effective mechanisms for ensuring quality,116 then public reporting may not have much effect. ultimately, in a world in which quality measurement is already underway, assessing whether a disclosure mandate is a “success” or “failure” requires a comparison between the marginal costs and the marginal benefits associated with adding a reporting requirement. the gains from reporting may be small, but if the marginal costs are smaller still, implementing the reporting mandate will have a positive net impact. if quality measurement is not yet underway, then the costs of implementing a measurement-based reporting regime should be compared not just to the benefits associated with reporting, but also to other benefits arising from the development of the underlying measurement infrastructure. 114 see julia james, health policy brief: pay-for-performance, health aff. 1 (oct. 11, 2012) (describing pay-for-performance programs). 115 see dep’t of health & human servs., improving quality of care for medicare patients: accountable care organizations (april 2014), https://www.cms.gov/medicare/medicare-fee-for-servicepayment/sharedsavingsprogram/downloads/aco_quality_factsheet_ic n907407.pdf [https://perma.cc/6aus-yr62] (describing quality metrics used as the basis for rewards in medicare's shared savings program and noting the alignment between the program and other quality reporting metrics). 116 see ben-shahar & schneider supra note 4 at 176 (describing results of studies of pay-for-performance programs). like the studies on quality reporting, studies on the impact of pay-for-performance are mixed. 340 indiana health law review vol. 13:2 the costs will almost certainly be large, but the gains may be as well. in short, an assessment of the net impact of reporting will depend not just on the attributes of the reporting mandate in question, but also on the nature of other quality-related initiatives already underway or soon to be adopted. these assessments will be challenging in an environment characterized by continuous reform; in such circumstances, longer-term gains will be much more difficult to evaluate than short-term costs. iv. alternatives to mandated disclosure given the prevalence of mandated disclosure as a regulatory mechanism, it is natural to respond to a call to abandon the mechanism with a question about how best to replace it. professors ben-shahar and schneider dismiss the question, and with good reason, if their premise is correct. if mandated disclosure does nothing, or makes things worse, then nothing is lost if it is abandoned. 117 the only question to be asked in such a case is whether there is some other sort of regulation or other initiative that would actually achieve the goals of the mandated disclosure, at a reasonable cost. ben-shahar and schneider do not explore this question in detail, as it is beyond the scope of their book, but they do discuss a few possibilities.118 this part explores two possible alternatives to reporting mandates: voluntary reporting and direct regulation. a. voluntary reporting as an alternative to mandatory quality reporting ben-shahar and schneider point out that there are often alternative sources of the kinds of information that reporting provides. many organizations provide consumer information, including ratings, reviews and other muchwanted forms of advice that mandated disclosures may lack.119 organizations that collect and disseminate 117 ben-shahar & schneider, supra note 4, at 183. 118 see id. at 183-95 (discussing alternatives to disclosure). 119 id. at 185. 2016 341 health care quality reporting: a failed form of mandated disclosure? information abound, and they do not necessarily need to obtain information through mandates.120 as ben-shahar and schneider suggest, it is true that private entities do not need publicly-reported health care quality data to create their own ratings. consumers can obtain advice similar to what they would get from government report cards through a number of private organizations that supply quality information drawn directly from providers, from public claims databases, or from third parties.121 this reality, though, creates problems of its own. to the extent that organizations' measures are derived from data supplied directly by providers, private reporting programs have the potential to add to the burden faced by providers that might already be reporting on hundreds of measures for public reporting or payment purposes.122 furthermore, a proliferation of quality metrics can also create considerable confusion for patients, who are confronted with many competing and sometimes contradictory quality metrics.123 in other words, a proliferation of voluntary reporting programs can create a sort of overload, just as an overly complex mandated disclosure can. professor craswell notes the problems of inconsistent measurement systems, and suggests that mandatory disclosures might benefit users by making direct comparisons easier and reducing the burden consumers would otherwise face in trying to understand multiple 120 id. at 187-88, 190. 121 see, e.g., 2015 leapfrog hospital survey results now available, the leapfrog group http://www.leapfroggroup.org/cp [https:// perma.cc/2yyx-yhnn] (last visited may 26, 2016) (reporting based on data supplied by hospitals); faq: how and why we rate hospitals, u.s. news & world report (july 21, 2015, 12:01 am), http:// health.usnews.com/health-news/best-hospitals/articles/2015/05/20/faqhow-and-why-we-rate-and-rank-hospitals?int=ab2909&int=ad4609 [https://perma.cc/pe4n-34lj] (describing hospital rating methodology involving physician surveys). 122 see, e.g., massachusetts health policy commission, 2014 cost trends report 59 (2014) (finding that massachusetts providers reported more than 400 quality measures to different entities). 123 michael b. rothberg et al., choosing the best hospital: the limitations of public quality reporting, 27 health aff. 1680, 1686 (2008). http://dx.doi.org/10.1377/hlthaff.27.6.1680 342 indiana health law review vol. 13:2 metrics.124 federal reporting websites do this to at least to some extent by providing information on a very large number of providers for a very broad range of services, and ensuring at least some consistency in the presentation of information. the federal government's purchasing power ensures that it has access to a broad range of provider data. by contrast, other quality-related websites may include only a subset of providers, or exist for only a particular type of care. it may be possible to achieve consistency in reporting through collaboration across entities, rather than by governmental mandate. recently, the center for medicare and medicaid services worked with major commercial health plans and others to increase the alignment across measures used for a variety of quality programs.125 however, even if such multistakeholder groups exist, the government’s leadership role in reporting initiatives may help to accelerate the process of reaching a voluntary agreement. craswell highlights one more important effect of a governmental mandate: he suggests that “when the government requires the disclosure of information, that decision itself signals to (some) consumers that the issue is important enough to worry about, thus making sellers' later voluntary disclosures more salient to consumers.”126 it is possible that this is the case for health care quality. by making data available to the public for free and publicizing its availability, policy makers may increase the public's focus on health care quality. for all of these reasons, mandatory reporting may yield gains that purely voluntary reporting programs might struggle to achieve. it is also the case that existing mandatory reporting regimes possess some of the attributes 124 craswell, supra note 22, at 368. 125 press release, cms and major commercial health plans, in concert with physician groups and other stakeholders, announce alignment and simplification of quality measures (feb. 16, 2016), https://www.cms.gov/newsroom/mediareleasedatabase/press-releases/ 2016-press-releases-items/2016-02-16.html [https://perma.cc/m7tkpdue]; patrick h. conway and the core quality measures collaborative workgroup, the core quality measures collaborative: a rationale and framework for public-private quality measure alignment, health aff. blog (june 23, 2015). 126 craswell, supra note 22, at 368. 2016 343 health care quality reporting: a failed form of mandated disclosure? that ben-shahar and schneider look for in alternative reporting mechanisms. for example, publicly-produced quality reporting would seem to fall in the category of “advice” that ben-shahar and schneider describe. furthermore, while other types of mandated disclosure may “rarely teach” “how businesses actually behave,” 127 quality report cards attempt to characterize actual behavior. in short, while a variety of information provision mechanisms might perform some key functions of reporting mandates, today’s quality reporting mechanisms offer important benefits for information users. b. direct regulation as an alternative to mandatory quality reporting ben-shahar and schneider also note that in some cases, more paternalistic forms of regulation might be a viable alternative to reporting mandates.128 if policy makers believe that having more nurses may help achieve higher quality of care, but are convinced by ben-shahar and schneider that a nurse staffing ratio report card will fail as a policy intervention, then perhaps they could regulate directly by mandating staffing ratios. the translation of some quality metrics, such as mortality rates, to command-and-control regulations is more challenging than the staffing ratio example implies, but in theory government regulators could become more active in mandating practices that have been found to reduce mortality. many people would view this kind of intervention as problematic on the grounds that it involves too much interference with the ever-changing practice of medicine. command-and-control regulation can forestall innovation and impose inappropriate or unnecessarily costly practices on providers. structural and process-based quality reporting measures allow for variation, even while pushing providers toward a particular standard; outcome-based metrics such as adjusted mortality rates provide flexibility to providers in how they seek to achieve better outcomes. a desire for flexibility is no reason to advocate for reporting that does not 127 id. at 188. 128 id. at 194. 344 indiana health law review vol. 13:2 work, but flexibility can help avoid some of the risks of command-and-control regulation. note too that command-and-control regulations are subject to many of the criticisms lodged against mandated disclosure, a point emphasized by professor craswell.129 nurse staffing mandates, like nurse staffing reporting requirements, could undermine quality if the metrics used are not actually associated with quality. a nurse staffing mandate pulls resources away from other areas in need of attention, possibly including areas that matter more for quality. a requirement for nurse staffing levels may lead to gaming that helps providers meet the requirement without improving outcomes. authors of a recent article that compares evidence on quality reporting with evidence on direct quality regulation argue that both approaches can “induce teaching to the test” and “be subject to cream skimming,” and then state that “[a]lthough very few efforts have been made to measure the costs of these approaches, regulation, when enforced, is almost certainly more costly.”130 this conclusion points to the advantages of reporting, but the authors' ultimate conclusion points in a different direction. while one of the authors' objectives was “to compare the effectiveness and cost-effectiveness of regulation and report cards in improving quality,” they conclude that “such a comparison is not yet feasible,” partly because studies evaluating the policy tools “use different metrics to measure their effects,” partly because they address different sectors, and partly “because of the dearth of cost studies.”131 129 see craswell, supra note 22, at 367. at the same time, disclosure mandates can share some of the shortcomings of command-and-control regulation. professor ryan bubb suggests that some disclosure mandates may be intended to manipulate consumer choice, rather than merely attempting to debias faulty consumer decision making, and “should be subjected to cost-benefit analysis in much the same way as are more transparently coercive tools like product regulation.” ryan bubb, tmi? why the optimal architecture of disclosure remains tbd, 113 mich. l. rev. 1021, 1039 (2015). 130 see mukamel et al., supra note 81, at 492. 131 see id. 2016 345 health care quality reporting: a failed form of mandated disclosure? v. conclusion the challenges of comprehensively evaluating the effects of policy interventions give room both to claims that disclosure mandates have failed, and to claims that they might succeed. while the evidence discussed in part ii.c makes clear that mandated quality reporting has the potential to succeed, part iii's evidence on costs is much sparser. it is certainly possible that reporting's costs exceed its benefits. on the other hand, it is also possible that gains exceed costs for at least some subset of current quality reporting initiatives. i lean toward this latter conclusion, in part because i believe that quality reporting has done a lot to focus providers' attention on quality issues, and in part because of the long-term benefits that investments in the infrastructure supporting quality reporting can yield. whatever may be true right now, i believe that it is likely that future versions of today's mandates will fare better in a cost-benefit analysis, both because i anticipate that reporting systems will be revised in light of emerging research about what works and what does not, and because i believe that the marginal costs of quality reporting will decline over time. i suspect that similar observations could be made for other forms of mandated disclosure, but i am not sure how much can be extrapolated from this essay’s analysis of quality reporting. it would not be unreasonable to view quality reporting as a sui generis form of disclosure mandate. it differs from other disclosure mechanisms in multiple ways. for example, the primary end goal of quality reporting does not seem to be fully informed consumers, but instead higher quality care; in other words, the ultimate aim is not to support patient (consumer) choice in a world with diverse products, but instead to ensure that the product delivered has a particular attribute. while many of the mandates professors ben-shahar and schneider consider involve the direct provision of information from a business to a consumer, health care quality reporting typically involves health care providers' provision of information to a government entity, which then makes information available to consumers. for many people, health care quality likely matters more than the specific details of privacy policies, or boilerplate contract terms that govern disputes that rarely 346 indiana health law review vol. 13:2 arise. quality report cards seem much more straightforward to understand than a mortgage. the fact that providers may find quality measurement useful for multiple purposes means that quality reporting processes may be intertwined with provider operations in ways that other kinds of disclosures meant to clarify product characteristics, such as term sheets, are not.132 this brief list of some of the ways that health care quality reporting differs from other mandates makes clear that there are many dimensions along which disclosure mandates may differ. they differ in their goals and the mechanisms by which they seek to achieve them.133 they differ in their degree of salience to their audiences.134 they differ in complexity. they differ in costs, financial and otherwise, and they may differ in who bears these costs. they may also differ in the extent to which alternative regulatory mechanisms could achieve their goals. 135 the sheer diversity of disclosure mandates raises the possibility that some disclosures will succeed while others fail; even ben-shahar and schneider leave open the possibility that at least some mandates succeed. if we could develop a framework that systematically lays out the key characteristics of disclosure mandates and the environments in which they operate, then 132 provider quality reporting mandates may also differ from other disclosure regimes in that they often take the form of “pay for reporting” initiatives, rather than statutory or regulatory requirements to report. see, e.g., home health quality reporting requirements, cms.gov, https://www.cms.gov/medicare/quality-initiatives-patient-assessmentinstruments/homehealthqualityinits/home-health-quality-reportingrequirements.html [http://perma.cc/pqm6-9g5f] (last modified 10/29/2015 3:25 pm) (noting that federal statute requires home health agencies to submit data, describing the financial consequences if home health agencies do not submit data, and describing the requirement as a “pay-for-reporting” requirement). 133 professor bubb offers a thoughtful discussion of the implications of disclosure mandates that seek to debias versus mandates that seek to manipulate behavior. bubb, supra note 129, at 1028-1039. 134 see mukamel et al., supra note 81, at 492 (noting that the risk of delayed treatment for pneumonia “may not be significant to enough potential patients to make report card effective; therefore, direct regulation may be a more appropriate approach than a report card”). 135 cf. id. (observing that reporting “is considered an attractive policy instrument in an area where surgeon skill is very important and probably difficult to regulate”). 2016 347 health care quality reporting: a failed form of mandated disclosure? we may be able to better predict disclosure mandate success — and increase it. the utility of such a framework will necessarily depend on the quality of data that underlies it. evaluating the success of existing mandates requires careful consideration of both benefits and costs. as professor bubb has observed, “[t]he right response to the important critiques of mandatory disclosure that ben-shahar and schneider raise is . . . rigorous empirical assessment of which disclosures work and which do not, with an eye toward the pitfalls the authors document.” 136 moreover, as professor craswell emphasizes, it will be important to define criteria for success, which will in turn depend on the nature of the goals policy makers seek to achieve.137 more than you wanted to know conveys an important warning: disclosure mandates rarely fulfill their advocates' hopes, and the reasons that disclosure mandates disappoint are not easily addressed. this essay demonstrates, however, that some disclosure-based policy strategies have a reasonable chance of succeeding. with more data, more analysis, and a clear articulation of policy goals, we can determine whether they actually do. 136 bubb, supra note 127, at 1023. 137 see craswell, supra note 22, at 337-40 (on goals); see also id. at 380 (calling for development of criteria for success). indiana health law review volume 11 2014 issue 1 table of contents mcdonald-merrill-ketcham memorial lectureship and award for excellence in law and medicine karen h. rothenberg setting the stage: enhancing understanding of bioethical challenges with theatre .............................................. 1 articles maya sabatello disclosure of gamete donation in the united states............. 29 daniel s. goldberg and ben rich pharmacovigilence and the plight of chronic pain patients: in pursuit of a realistic and responsible ethic of care ..... ......... 83 eric merriam legal but unethical: interrogation and military health professionals ................................. ....... 123 mark t. morrell and alex t. krouse accountability partners: legislated collaboration for health reform............................................. 225 notes paul k. ho hcqia does not provide adequate due process protection, improve healthcare quality and is outdated under "obama care"............... 303 jessica m. dugdale a plea for consumer protection: the potential human health hazards of the spray tanning epidemic............................. 347 christopher m. anderson striking a balance: regulation of raw milk and a new approach for indiana................ ................... ..... 399 megan m. smith causing conflict: indiana's mandatory reporting laws in the context of juvenile defense ............................... ..... 439 indiana health law review 2013-2014 editor-in-chief janice pascuzzi executive managing editor samuel dayton executive editor thomas martin executive business editor jessica dugdale note development editors paul ho charity mansfield james nussbaum executive notes editor nicole sharp executive articles editor james banister executive production editor romy elswerky articles editors christopher anderson charlotte fillenwarth laura sahm note candidates zahra ayoubi samantha chapman whitney dather brandie ecker matthew folz michael hooker james jared jake kolisek matthew lorenzo kristi mcmains cathleen nine-altevogt tyler olson andrew podgomy allison potenza julie riche ,colby schade van westrum jason sprinkle julian stephenson robert whitham justin wiser faculty advisors nicolas p. terry (chair) david orentlicher (chair) eleanor d. kinney (adviser emerita) robert a. katz emily morris miriam murphy (research liaison) ben keele (research liaison) volume i i 2013-2014 indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2013-14 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university robert h. mckinney school of law. subscriptions. the current subscription rate is $20.00 for two issues (domestic mailing). unless the business office receives notice to the contrary, all subscriptions will be renewed automatically. claims for non-receipt of the current year's issues must be made within six months of the 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cost, and that the author, source, and copyright notice are included on each copy. this permission is in addition to rights of reproduction granted under sections 107, 108, and other provisions of the u.s. copyright act and its amendments. the indiana health law review (issn 1549-3199) is the property of indiana university and is published two times per year by the indiana university robert h. mckinney school of law, which assumes complete editorial responsibility thereof. contact us. editorial and business offices are located at: indiana health law review lawrence w. inlow hall 530 w. new york street, room 136c indianapolis, in 46202-3225 (317) 278-9519 publisher. the indiana health law review is published and distributed by western newspaper publishing company, inc., 537 e. ohio st., indianapolis, in 46204-2173. unintended consequences: prohibitions on gamete donor anonymity and the fragile practice of surrogacy unintended consequences: prohibitions on gamete donor anonymity and the fragile practice of surrogacy gaia bernstein* abstract............................................. 291 i. introduction ...................................... 292 ii. the practice of surrogacy ....................... 297 iii. the impact of prohibitions on gamete donor anonymity on gamete supplies .................. 299 iv. a preference for gestational surrogacy ............. 308 a. legal preference ........................... 308 b. medical practioners' preference ............... 315 v. potential ramifications of prohibition on gamete donor anonymity on the practice of surrogacy . 318 a. return to traditional surrogacy ............... 318 b. refrain from surrogacy altogether ............. 321 vi. conclusion ........................... ..... 323 abstract prohibitions on anonymous egg and sperm donations are a growing international trend. u.s. law does not prohibit anonymous gamete donations. however, an expanding movement is advocating a shift to an open identity regime that will ban anonymity. my earlier study of three jurisdictions: sweden, victoria (australia) and the united kingdom, which adopted prohibitions on gamete donor * professor of law, seton hall university school of law. for their invaluable comments, i owe thanks to judith daar, theresa glennon and the participants of the following conferences: the international law association meeting at fordham law school, the imagining the next quarter century of health care law symposium at the robert h. mckinney school of law, indiana university, the baby markets conference at the indiana university maurer school of law, and the health law professors conference at arizona state university. i would also like to thank laura green, jeanne o'connor, julie rich, eric suggs and meredith traina for their excellent research assistance. indiana health law review anonymity, showed that these prohibitions played a role in creating shortages in egg and sperm supplies. adoption of prohibitions on anonymity in the united states could result in similar shortages. this article focuses on the potential effects of prohibitions on anonymity on the practice of surrogacy. the practice of surrogacy in the united states is highly dependent on donor eggs. unlike most jurisdictions that prohibit gamete donor anonymity, the majority of u.s. states that permit surrogacy, distinguish between gestational and traditional surrogacy. in traditional surrogacy, the surrogate uses her own eggs and is the genetic mother of the conceived baby. however, in gestational surrogacy, the eggs of the intended mother or a donor are used and the surrogate is not the genetic mother. donor eggs are used only in gestational surrogacy but not in traditional surrogacy. states that distinguish between traditional and gestational surrogacy provide legal certainty only to gestational surrogacy while leaving traditional surrogacy in a legal limbo. infertility practitioners endorse the legal preference for gestational surrogacy.. this article advises that a shift toward an open identity system in the united states should be considered with extra caution because of the potential consequences to the practice of surrogacy. prohibitions on gamete donor anonymity causing a scarcity in donor eggs could force a return to traditional surrogacy, with the accompanying legal uncertainty. alternatively, the legal uncertainty enveloping traditional surrogacy could deter those in need of surrogacy from seeking it altogether thereby significantly contracting the practice of surrogacy. i. introduction prohibitions on gamete donor anonymity are a growing international trend. since 1985, eleven jurisdictions: sweden, austria, switzerland, the netherlands, norway, the united kingdom, new zealand, finland, and the 292 vol. 10: 2 prohibitions on gamete donor anonymity australian states of victoria, western australia, and new south wales have prohibited anonymous gamete donations.' in addition, a prohibition on gamete donor anonymity is currently being litigated in canada, following a judicial decision prohibiting anonymity2 in these jurisdictions, egg and sperm donors are not anonymous. instead, typically, when the child conceived through gamete donation reaches the age of eighteen, he can receive the identifying information of his genetic parents the sperm or egg donor. u.s. law does not prohibit anonymous gamete donation.3 however, a growing movement of commentators is advocating a shift to an open identity model that would ban anonymity.4 furthermore, in 2011, washington state was the first u.s. state to adopt a modified open identity statute.5 the washington statute makes open identity the default option, unless donors opt out. however, even if a 1 eric blyth & lucy frith, donor-conceived people's access to genetic and biographical history: an analysis of provisions in different jurisdictions permitting disclosure of donor identity, 23 int'l j. l. pol'y & fam. 174, 174-76 (2009) [hereinafter disclosure of donor identityl. 2 see pratten v. british columbia (att'y gen.), 2011 bcsc 656, 215 (can.). 3 see naomi r. cahn, test tube families: why the fertility market needs legal regulation 115 (2009) [hereinafter test tube families]. 4 see generally id. at 114-29, 215-37; naomi cahn, necessary subjects: the need for a mandatory national donor gamete databank, 12 depaul j. health care l. 203 (2009) [hereinafter necessary subjects]; michelle dennison, revealing your sources: the case for non-anonymous gamete donation, 21 j.l. & health 1, 3 (2007-08); mary lyndon shanley, collaboration and commodification in assisted procreation: reflections on an open market and anonymous donation in human sperm and eggs, 36 law & soc'y rev. 257 (2002). but see mary patricia byrn & rebecca ireland, anonymously provided sperm and the constitution, 23 colum. j. gender & l. 1 (2012) (pointing out that banning anonymity poses constitutional issues). 5 bonnie rochman, where do (some) babies come from? in washingtoa, a new la w bans anonymous sperm and egg donors, time magazine, jul. 22, 2011, http://healthland.time.com/2011/07/22/ where-do-some-babies-come-from-in-washington-a-new-law-bansanonymous-sperm-and-egg-donors/. 2932013 indiana health law review donor opts out of disclosing his identifying information to the conceived child, his medical records remain available.6 as the debates on gamete donor anonymity gain steam, they usually focus on the privacy and procreative liberty interests of the parents, the privacy interests of the donors, the best interests of the born children and the effects on the supply of donor gametes.7 in a previous study, i have explored the impact of prohibitions on gamete donor anonymity on the supplies of egg and sperm and the potential effect on the broad population of fertility patients in need of donor gametes.8 this article addresses unexplored aspect of the gamete supply problem, which is practically unique to the united states, and which could 6 see wash. rev. code § 26.26.750 (2012). 7 for discussions of the interests of the children, see test tube families, supra note 3, at 218-20; jean benward et al., maximizing autonomy and the changing view of donor conception: the creation of a national donor registry, 12 depaul j. health care l. 225, 232-34 (2009); naomi cahn, the new kinship, 100 geo. l.j. 367 (2012); dennison, supra note 4, at 14-16; glenn cohen, regulating reproduction: the problem with best interests, 96 minn. l. rev. 423, 461-65 (2011) [hereinafter best interests]; glenn cohen, response: rethinking sperm -donor anonymity of changed selves, nonidentity, and one-night stands, 100 geo. l.j. 431 (2012) [hereinafter response]; shanley, supra note 4, at 268-70. for discussion of additional interests, see gaia bernstein, regulating reproductive technologies: timing, uncertainty and donor anonymity, 90 b.u. l. rev. 1189, 1205-1218 (2010) [hereinafter regulating reproductive technologies] (revealing the impact of prohibitions on gamete donor anonymity on gamete supplies in victoria, sweden, and the united kingdom); glenn cohen & travis g. coan, can you buy sperm donor identification? an experiment (harvard law sch. pub. law & legal theory research paper series, working paper no. 12-36, 2012), available at http://papers.ssrn.com/sol3/papers.cfm?abstractid=2109550#%23 (examining the effect of prohibitions on anonymity on compensation for gamete donations); lucy frith, gamete donation and anonymity: the ethical and legal debate, hum. reprod. 818, 820-22 (2001) (discussing the interests of parents and children); sonia m. suter, giving in to baby markets: regulation without prohibition, 16 mich. j. gender & l. 217, 260-73 (2009) (discussing the interests of parents, donors, and children); ilke turkmendag, robert dingwall & th6rbse murphy, the removal of donor anonymity in the uk the silencing of claims of would-be parents, 22 int'l j. l. pol'y & fam. 283, 292 (2008) (emphasizing the neglect of the interests of the parents under the new u.k. policy). 8 bernstein, supra note 7, at 1205-18. 294 vol. 10:2 prohibitions on gamete donor anonymity affect a subset of individuals in need of gamete donation fertility patients who require both egg donation and a surrogate in order to have a child. this article examines the way in which adoption of prohibitions on gamete donor anonymity in the united states could affect gamete supplies and unintentionally destabilize the practice of surrogacy. my earlier study of victoria (australia), sweden and the united kingdom, each of which adopted prohibitions on gamete donor anonymity, revealed a disconcerting picture of the effect of these prohibitions on gamete donor supplies. although the data is inconsistent at times, all three jurisdictions suffer from significant shortages in donor gametes accompanied by long wait-lists for recipients. although the prohibition on gamete donor anonymity is not necessarily the only factor leading to a shortage in donor gametes, it appears to have played an important role in creating these shortages. 9 surrogacy practice in the united states is highly dependent on donor eggs. there are two types of surrogacy arrangements. the first is traditional surrogacy, in which the surrogate is inseminated with sperm from the male partner of the intended parents or with donor sperm. in this type of surrogacy the surrogate's eggs are used and she is the genetic mother of the child she carries.10 the second type is gestational surrogacy, in which the surrogate carries an embryo created through in vitro fertilization (ivf) with the sperm and eggs of the intended parents or donors. in this type of surrogacy the surrogate is not the genetic mother of the baby because her eggs are not used. 11 gestational surrogacy often involves donor eggs, not the intended mother's eggs. the most recent available data 9 id. 10 janice c. ciccarelli & linda j. beckman, navigating rough waters: an overview of psychological aspects of surrogacy, 61 j. soc. issues 21, 21 (2005); american society for reproductive medicine, third party reproduction: a guide for patients 13 (2012), available at http://www.reproductivefacts.org/uploadedfiles/asrm content/resources/patientresources/factsheets andinfobooklets/ thirdparty.pdf. 11 ciccarelli & beckman, supra note 10; american society for reproductive medicine, supra note 10, at 13. 2952013 indiana health law review shows that 46% of reported ivf cycles for surrogacy involved donor eggs. furthermore, donor eggs are usually eggs of younger women, and are, therefore, more likely to produce a pregnancy and a live birth through surrogacy, than cycles using the intended mother's eggs.12 yet, while gestational surrogacy is highly dependent on donor eggs, the united states, unlike most other jurisdictions that prohibit gamete donor anonymity, legally differentiates between gestational surrogacy and traditional surrogacy (which does not require donor eggs of a third party). currently, fifteen states clearly permit surrogacyl 3; however, eleven accord gestational surrogacy legal certainty while leaving traditional surrogacy in a legal limbo.14 only four states that permit surrogacy, afford both traditional surrogacy and gestational surrogacy the same level of legal certainty.15 unsurprisingly, gestational surrogacy has become more common than traditional surrogacy. fertility practitioners prefer gestational surrogacy partly because of the enhanced legal certainty it offers all participants in the surrogacy arrangement. they also choose it because they believe that a gestational surrogate who is not genetically related, is less likely to change her mind and refuse to deliver the baby to the intended parents.16 the legal and medical preference in the united states for gestational surrogacy, which is highly dependent on donor eggs, raises concern that prohibitions on gamete donor anonymity could have detrimental ramifications for the practice of surrogacy. prohibitions on gamete donor anonymity played a role in creating donor shortages in jurisdictions that adopted them. some potential donors concerned about future contact with their conceived genetic 12 see infra text accompanying notes 22-23. 13 these states are: arkansas, california, florida, illinois, louisiana, massachusetts, nevada, new hampshire, new jersey, north dakota, ohio, texas, utah, virginia and washington. see infra part iv(a). 14 these states are: these states are: california, florida, illinois, louisiana, massachusetts, nevada, new jersey, north dakota, ohio texas and utah. see infra text and accompanying footnotes 86-89. 15 see infra part iii(a). 16 see infra part 111(b). 296 vol. 10: 2 prohibitions on gamete donor anonymity offspring decided not to donate their gametes. adoption of these prohibitions in the united states could contribute to creating donor gamete shortages and destabilize the practice of surrogacy in two ways. first, a scarcity in donor eggs could force a return to traditional surrogacy (in which the surrogate provides the eggs and not a third party) with the accompanying legal uncertainty. second, the legal uncertainty enveloping traditional surrogacy could deter those in need of the services of a surrogate from seeking it altogether, resulting in a contraction of the practice of surrogacy in the united states. although social attitudes toward surrogacy may change as the twenty-first century progresses, the potential ramifications from an abrupt change to an open identity system point to the need to act with caution when considering this change. 17 part i of this article provides a brief introduction to the practice of surrogacy. part ii discusses the impact of prohibitions on gamete donor anonymity on the supplies of donor gametes in three jurisdictions: victoria (australia), the united kingdom and sweden. part iii examines the legal and practitioner preference for gestational surrogacy over traditional surrogacy in the united states. part iv discusses the potential destabilization of the practice of surrogacy in the united states should prohibitions on gamete donor anonymity become common. ii. the practice of surrogacy the practice of surrogacy is comprised of two types of surrogacy. the first is traditional surrogacy, in which the surrogate is inseminated with sperm from the intended father or with donor sperm. in this type of surrogacy, the surrogate's eggs are used to conceive the baby and she is his genetic mother.18 the second type is gestational surrogacy, in which the surrogate carries a baby conceived through ivf with the sperm and egg of the intended parents or donors. in this type of surrogacy the surrogate's eggs are 17 see infra part v. 18 ciccarelli & beckman, supra note 10; american society for reproductive medicine, supra note 10, at 3. 2013 297 indiana health law review not used, and, therefore, she is not the genetic mother of the conceived baby.19 the full scope of the practice of surrogacy in the united states is unknown. there is no data available on traditional surrogacy, which is conducted via artificial insemination, a simple procedure that can be even done at home without the involvement of a doctor.20 information about surrogacy is limited because the parties involved "have no incentive to report their numbers given the ethical debate and fear of regulatory action."21 two organizations collect information about gestational surrogacy: the society of assisted reproductive technologies (sart) and the center for disease control and prevention (cdc).22 however, that data lags behind, does not encompass all fertility clinics, is only partly nationally aggregated, and is not completely available to the public. the council of responsible genetics released, in 2010, a report titled surrogacy in america, which contains the most comprehensive analysis of the data available from the cdc and sart.23 although the report only analyzes data through 2007-2008, it gives a glimpse of the gestational surrogacy market. the report shows that the market for gestational surrogacy is growing. it reveals that from 2004 to 2008 the number of ivf cycles used for gestational surrogacy grew by 60%, the number of births by gestational surrogates grew by 53% and the number of babies born to gestational surrogates grew by 89%.24 the report's analysis of the data suggests a high reliance on donor eggs. it 19 american society for reproductive medicine, supra note 10, at 13-14. 20 council for responsible genetics, surrogacy in america, 6-7, 26 (2010), http://www.councilforresponsiblegenetics.org/pagedocuments/ kaevej0alm.pdf. 21 id. at 5. 22 id. at 4. 23 id. 24 see id. at 3. yet, even these numbers are incomplete because they do not include all fertility clinics in the united states and cover only completed ivf cycles, excluding incomplete ones. id at 8. therefore, these numbers cannot report how many women serve as gestational surrogates. id. 298 vol. 10:2 prohibitions on gamete donor anonymity assesses that in 2007, medical practitioners performed 1,293 ivf cycles involving gestational surrogates. 25 it also reports that 733 non-donor ivf cycles involving gestational cycles were conducted that year.26 thus, 560 cycles, 46% of the total number of ivf cycles, were conducted using donor eggs. this figure is of particular importance because cycles using donor eggs, which are typically eggs from younger women, are more likely to result in a pregnancy and live birth. thus, the percentage of gestational surrogate babies born through cycles using donor eggs is likely much higher than 46% of the total number of babies born through ivf cycles involving surrogates. iii. the impact of prohibitions on gamete donor anonymity on gamete supplies prohibiting gamete donor anonymity is a growing global trend. in jurisdictions prohibiting anonymity, egg and sperm donors are not anonymous. instead, typically, when the child reaches the age of eighteen he can find out the identity of the egg or sperm donor his genetic parent.27 the main goal driving the movement toward an open identity system are beliefs that children need to develop their own identity, and that possession of information regarding their genetic origins is crucial for that purpose. 28 prohibitions on gamete donor anonymity are currently in place in eleven jurisdictions. these jurisdictions include: 25 see id. at 8-9 (reporting cdc data). sart data for 2008 is significantly higher, reporting 2,502 gestational surrogate ivf cycles, 987 gestational births and 1,395 born babies. the difference is due to the fact that 53 of 483 fertility clinics do not report to cdc but do report to sart. at the same time, not all ivf clinics are members of sart, therefore, it is likely that both data-sets are under-inclusive. id. at 12. 26 id. at 9. 27 see, e.g., the infertility treatment act, 1995 (vic) s 70 (austl.) (victorian law permitting donor conceived children to receive information about the donor once they reach the age of eighteen); human fertilisation & embryology authority (disclosure of donor information), regulations 2004, s.i. 2004/1511, art. 2, 2-4 (u.k.) (united kingdom law permitting donor conceived children to receive information about the donor once they reach the age of eighteen). 28 see test tube families, supra note 3, at 114-129, 215-237. 2013 299 indiana health law review sweden, austria, switzerland, the netherlands, norway, the united kingdom, new zealand, finland, and the australian states of victoria, western australia, and new south wales. 29 in addition, a prohibition on gamete donor anonymity is presently under judicial review in canada, following a court's decision prohibiting anonymity.30 u.s. law does not prohibit anonymous gamete donation. 31 yet, a growing movement of commentators and advocates is pursuing a shift to a regime that prohibits gamete donor anonymity.32 moreover, in 2011, washington state was the first state in the united states to adopt a statute that makes a prohibition on anonymity the default option the donor has to reveal her identity, unless she opts out. yet, even if a donor opts out, the donor's medical records will remain available to the conceived offspring.33 prohibitions on gamete donor anonymity impact a broad host of interests. commentators have been concerned with the best interests of the children. 34 specifically, advocates of these prohibitions emphasize the importance of allowing donor conceived children to develop their identities, to access their family medical history and to avoid accidental incest with another offspring of the donor. 35 those opposed to prohibitions on anonymity discussed the privacy and procreative interests of the intended parents, who may not want their donor-conceived child to know he or she is not 29 disclosure of donor identity, supra note 1, at 174-76. 30 see pratten v. british columbia (att'y gen.), 2011 bcsc 656, 215 (can.). 31 test tube families, supra note 3, at 115. 32 see generally id. at 114-29, 215-37; necessary subjects, supra note 4; dennison, supra note 4, at 3; shanley, supra note 4. but see byrn & ireland, supra note 4 (pointing out that banning anonymity poses constitutional issues). 33 see wash. rev. code § 26.26.750 (2012). 34 see generally best interests, supra note 7, at 461-65; response, supra note 7; shanley, supra note 4, at 268-70. 35 for discussions of the importance of developing the child's identity, see test tube families, supra note 3, at 114-129; benward et al., supra note 7, at 232-34; shanley, supra note 4, at 268-70. for a discussion of health concerns and the risk of incest, see, e.g., dennison, supra note 4, at 14-16. 300 vol. 10:2 prohibitions on gamete donor anonymity their genetic child. 3 6 finally, commentators raised concerns regarding the impact on the privacy interests of the donors, who may not desire contact with the conceived child and the potential impact on donors' willingness to donate in an open identity system.37 yet, in this article i focus on only one aspect of the debate the impact on gamete donor supplies in order to examine the potential repercussions for a subset of fertility patients: those needing both donor egg and a surrogate in order to have a child. in a study i published in 2010, i examined the impact of prohibitions on gamete donor anonymity on gamete donor supplies. 38 i studied the data available from three representative jurisdictions that prohibit anonymity: sweden, the australian state of victoria and the united kingdom. 39 my study showed that, despite not always 36 see, e.g., turkmendag, dingwall & murphy, supra note 7, at 292 (emphasizing the neglect of the interests of the parents under the new u.k. policy); byrn & ireland, supra note 4, at 5-15 (examining the impact of a prohibition on donor gamete anonymity on the intended parents constitutional right to procreate); julie l. sauer, comment: competing interests and gamete donation: the case for anonymity, 39 seton hall l. rev. 919, 945-47 (2009) (arguing that the intended parents interests should be considered when examining prohibitions on gamete donor anonymity). 37 see, e.g., bernstein, regulating reproductive technologies, supra note 7. at 1205-1218 (examining the impact of prohibitions on gamete donor anonymity on gamete supplies in victoria, sweden and the united kingdom); cohen & coan, supra note 7, (examining the effect of prohibitions on anonymity on compensation for gamete donations); sauer, supra note 36, at 943-45 (arguing that the donors privacy interests should be considered when examining prohibitions on gamete donor anonymity). 38 see generally bernstein, supra note 7. 39 id. at 1190. "i selected sweden and victoria because they are the first jurisdictions in which donor anonymity was prohibited. therefore, donor-conceived children have reached or are reaching the age at which they can demand to know the donor's identity. additionally, in these jurisdictions there is relatively more data than in other jurisdictions on the effects on the number of gamete donors. i selected the united kingdom as a representative of a jurisdiction in which anonymity was recently prohibited. the prohibition on anonymity in the united kingdom is currently in the midst of a heated debate and, therefore, the effects of this shift are well-documented and quantified. i should add that although i did not provide detailed information on the data in the 2013 301 indiana health law review consistent data, an overall picture of dire shortages in donor gametes. 40 the study first examined sweden, which in 1985 was the first jurisdiction to pass a law that allowed a child, conceived with donor sperm, to find out the identity of the donor.41 the study found that although early reports showed a decrease in the number of gamete donors based on the number of new donors per year, a 1995 article relying on data up to 1993, found a subsequent increase. 42 based on the 1995 article, commentators believed that the prohibition on donor anonymity caused only an initial decline in gamete donor supplies. 43 yet, further investigation revealed that no one has conducted an additional study in sweden since the mid-1990s and also that the swedish authorities do not publish the relevant data 44 but, indirect data regarding the number of donor inseminations and media reports of donor sperm shortages and long wait-lists indicated an ensuing scarcity in donor supplies. 45 secondly, the study examined, victoria, an australian state, which was one of the first jurisdictions to prohibit gamete donor anonymity.46 victoria instated an open other jurisdictions in which anonymity was prohibited, the overall situation of gamete shortage and long wait-lists in these jurisdictions does not appear to differ from the situation in victoria, sweden, and the united kingdom." id. at 1207, n. 101. 40 id. at 1219. 41 id. at 1207; erling ekerhovd, anders faurskov & charlotte werner, swedish sperm donors are driven by altruism, but shortage of sperm donors leads to reproductive travelling, 113 upsala j. med. sci. 305, 305 (2008). 42 bernstein, supra note 7, at 1207-08. 43 e.g., ken daniels & othon lalos, the swedish insemination act and the availability ofdonors, 10 hum. reprod. 1871, 1872-73 (1995). 44 bernstein, supra note 7, at 1208. 45 id. (noting that sweden allows compensation of donor gametes; therefore, a prohibition on compensation has not played a role in creating shortages); see also 8 ch. 6 § lag om genetisk integritet [the genetic integrity act], (svensk fdrfattningssamling [sfs] 2006:351) (swed.) (since 2006, sweden has begun prohibiting trading in eggs and sperm for profit, but gamete owners who donate their gametes are still compensated.). 46 bernstein, supra note 7, at 1209. 302 vol. 10:2 prohibitions on gamete donor anonymity identity regime in two stages. first, in 1985, it enacted the infertility (medical procedures) act 1984 ("infertility act of 1984"), which went into effect in 1988, and created a donor register.47 however, under the infertility act of 1984, no information could be released without the donor's consent. 48 in 1995, the victorian legislature enacted the infertility act of 1995, which came into effect in 1998, and allowed donor conceived children to access information about donors once they reach the age of eighteen.49 the study examined officially released figures of the number of new donors per year and showed that although the number of sperm donors fluctuated between individual years, the figures demonstrated a gradual decline in the number of new donors, corresponding with the enactment and enforcement of the two acts.50 the study noted that while other factors, including the introduction of more effective reproductive technologies, such as ivf and intracytoplasmic sperm injection ("icsi") could have decreased the need for sperm donors, the media continues to report shortages in sperm supply.51 47 the infertility (medical procedures) act, 1984 (vic) s 19 (austl.). 4 8 id. 49 the infertility treatment act, 1995 (vic) s 70 (austl.). for a description of the legislative history in victoria, see lyria bennett moses, understanding legal responses to technological change: the example of in vitro fertilization, 6 minn. j.l. sci. & tech. 505, 555-59 (2005). in addition, the national health and medical research council in australia publishes ethical guidelines requiring use of gametes from donors who agree to release their identifying information. these guidelines are not mandatory. see also austl. nat'l health & med. research council, ethical guidelines on the use of assisted reproductive technology in clinical practice and research § 6.1, at 25-26 (2007), available at http://www.nhmrc.gov.aufiles-nhmrc/file/ publications/synopses/e78.pdf. 50 bernstein, supra note 7, at 1209-10. 51 id. at 1210-11. the study acknowledged that another factor that contributed to the decrease in gamete donors is the federal australian prohibition on compensation. however, it notes that this prohibition was only enacted in 2006 and went into effect in 2007 and, therefore, does not account for the earlier gamete shortage. see the prohibition of human cloning for reproduction and the regulation of human embryo research amendment act 2006 (cth) s 21 (austl.) (prohibiting donor compensation in excess of reasonable expenses). the relevant 2013 303 indiana health law review finally, the study examined the impact on gamete supplies in the united kingdom, where a law prohibiting donor gamete anonymity came into effect in 2006.52 the study assessed the official data released and concluded that it portrayed a mixed picture. 53 the data did not reveal more than an initial decline in the yearly number of newly registered donors. 54 however, the study noted that some reports point out that the numbers of registered donors is misleading because of the increase in known donors friends or relative who usually donate for only one person's exclusive use.5 5 at the same time, other parts of the data raised concern. the study's examination of the data revealed a decline in the number of newly registered egg share donors (women undergoing ivf to have their own child and donating excess eggs).56 in addition, examining indirect data, it noted a decline in the number of ivf treatment cycles with donated eggs or sperm. 57 the study concluded that although the data from the united kingdom is mixed, it warrants concern regarding the impact that the prohibition on gamete donor anonymity had on the availability of the gamete supplies.5 8 moreover, these prohibition in the state of victoria was enacted in 2008 and came into effect on january 1, 2010. the prohibition of human cloning for reproduction act 2008 (cth) s 17 (austl.). 52 human fertilisation & embryology authority (disclosure of donor information), regulations 2004, s.i. 2004/1511, art 2. t 1 (u.k.). 53 bernstein, supra note 7, at 1211. 54 id. 55 id. at 1211-12. 56 id. at 1212. 57 id. although the number of treatment cycles began declining since 2001, suggesting that other factors such as utilization of more effective reproductive technologies played a role here. 58 id. since this article focuses on the potential impact of prohibitions on anonymity on the supply of eggs for surrogacy, the united kingdom data, which includes data on eggs is particularly important. my study was conducted a relatively short time after the prohibition on anonymity came into effect in the united kingdom. unfortunately, the current data does not provide a clearer picture. as before, the overall number of newly registered egg donors is generally not lower than before the law came into effect. new donor registrations, human fertilization and embryology auth., http:// www.hfea.gov.uk/3411.html (last visited feb. 2, 2013). however, the 304 vol. 10:2 prohibitions on gamete donor anonymity concerns are exacerbated in light of media and commentator reports of long wait lists for donor gametes. 59 however, the study noted that although it appears that the prohibition on anonymity played a role in decreasing gamete supplies, other factors such as the prohibition on compensation for gamete donors, likely also played a significant part in enhancing the shortage. 60 the study suggested that potential donors' concerns of future contact by the conceived offspring influenced their decision-making. 6 1 in light of the study's findings in other jurisdictions, the adoption of prohibitions on anonymity in the united states could play a role in creating shortages in gamete supplies. as was the case abroad, potential donors in the united states may be deterred from donating, fearing future contact by the conceived offspring. since prohibitions on gamete donor anonymity are likely to be adopted on a state-by-state basis and not by the federal government, the effect on gamete supplies would depend on the number of states that would adopt these prohibitions. at the same time, advocates of an open identity system are likely to point to the fact that, unlike some jurisdictions that prohibit anonymity, compensation for gamete donors is not prohibited in the united states. and importantly, glenn cohen and travis coan have shown that sperm donors are human fertilization embryology authority no longer releases the data of newly registered egg share donors per year. egg share donors and non-patient egg donors, human fertilization and embryology auth., http://www.hfea.gov.uk/3412.html (last visited feb. 2, 2013). it only publishes the overall number of yearly egg share donors. egg share donors and non-patient egg donors, human fertilization and embryology auth., http://www.hfea.gov.ukl3412.html (last visited feb. 2, 2013). therefore, it is impossible to confirm whether the levels of newly registered egg share donors have risen or declined since i have conducted my study. at the same time, the number of ivf treatment cycles with donated eggs are still well below the number of cycles conducted before the law came into effect. donor conception patient and treatment, human fertilization and embryology auth., http:// www.hfea.gov.uk/donor-conception-treatments.html (last visited feb. 2, 2013). 59 bernstein, supra note 7, at 1212-13. 60 id. at 1213. 61 id. at 1215. 3052013 indiana health law review willing to reveal their identity for a higher compensation. 62 this suggests that prohibitions on donor gamete anonymity may not create shortages in the united states, but instead raise prices for sperm and egg. it is possible that prohibitions on compensation combined with prohibitions on gamete donor anonymity played a role in creating gamete donor shortages in other jurisdictions. nevertheless, in sweden and victoria, prohibitions on anonymity affected donor supplies even in the absence of prohibitions on compensation.63 furthermore, cohen and coan's study has two important limitations. first, the authors acknowledged that the study was only a hypothetical study.64 the participants did not, in fact, donate their sperm.65 interestingly, even in the jurisdictions in which my study observed a decline in donor gametes, hypothetical studies did not predict this decline.66 secondly, cohen and coan's study shows that prohibitions on anonymity would cause a price increase of 73% in the price of sperm. 67 sperm is relatively cheap costing the average price of $300 per vial,68 while eggs are more expensive. the average price recipients 62 glenn cohen & travis g. coan, supra note 7, at 4. 63 bernstein, supra note 7, at 1209, 1211. 64 glenn cohen & travis g. coan, supra note 7, at 24. 65 id. at 9. 66 see, e.g., k. daniels et al., short communication: previous semen donors and their views regarding the sharing of information with offspring, 20 hum. reprod. 1670, 1671, 1673 (2005); k.r. daniels, semen donors: their motivations and attitudes to their offspring, 7 j.reprod. & infant psych. 121 (1989, see also julian n. robinson & robert g. forman et al., attitudes of donors and recipients to gamete donation, 6 hum. reprod. 307, 307-308 (1991) (showing that while existing donors are not deterred by loss of anonymity, potential donors are); but see, rachel cook & susan golombok, a survey of semen donation: phase i the view of the donors, 10 hum. reprod. 951, 954 (1994) (finding that two-thirds of donors stated that they would not donate if their identifying information would be given to the conceived child). 67 cohen & coan, supra note 7, at 23. 68 see deborah l. spar, the baby business: how money, science and politics drive the commerce of conception, at xvi (2006). 306 vol. 10:2 prohibitions on gamete donor anonymity pay an egg donor is $4,500.69 thus, a similar increase in the price for eggs could result in a significant contraction of the market for eggs because few buyers will be able to afford the purchase. consequently, even in the absence of prohibitions on compensation, prohibitions on anonymity in the united states carry the risk of depleting gamete supplies. in addition, the data provided focuses mostly (excluding the united kingdom) on sperm donors. some commentators believe that egg donors may be less affected by the removal of anonymity than sperm donors because they are more interested in the outcome of their donation.70 while many studies examined the attitudes of sperm donors and egg donors toward anonymity and the conceived offspring, the two were not compared in a single study.71 interestingly, one study comparing the attitudes of egg and sperm donors toward the conceived children, although not focusing directly on anonymity, showed that sperm donors felt a paternity relationship to the conceived children, while egg donors distanced themselves from the conceived children as not having a family relationship to them.72 thus, in the absence of conclusive data comparing sperm and egg donors' attitudes toward the removal of anonymity, it is impossible to predict whether removal of anonymity in the united states will have disparate impact on egg donors. finally, social attitudes toward anonymity may change as the twenty-first century progresses. 73 one might argue 69 see id. and this price is, in fact, much higher because the recipient also has to pay for all the donor's retrieval costs. these costs can amount to an additional $10,000 per retrieval cycle. see ellen sarasohn glazer & evelina weidman sterling, having your baby through egg donation, 211-212 (2011). 70 see, e.g., eric blyth & lucy frith, the uk's gamete donor crisis -a critical analysis, 28 critical soc. policy, 74, 83-84 (2008). 71 see id. at 83, for acknowledgement that variation in study design, chronology and cultural contexts in which different studies have been undertaken need to be taken into account when comparing and contrasting the views of egg and sperm donors. 72 see rene almeling, sex cells: the medical market for eggs and sperm 143-153 (2011). 73 as was the case with the social acceptance accompanying the shift from closed to open adoption records. see ellen waldman, what do we tell the children? 35 cap. u. l. rev. 517, 520-532 (2006). 2013 307 indiana health law review that a society that is open to the idea of identified donors is more likely to produce a larger pool of donors who would be willing to donate despite the absence of anonymity. however, current evidence from jurisdictions like sweden and victoria, where prohibitions on donor anonymity have been in force for over two decades, does not indicate such a shift. instead, it appears that prohibitions on anonymity still play a role in creating shortages in gamete donations in these jurisdictions. and, although attitudes may change globally and domestically in coming years, without evidence of a shift of attitudes, concerns regarding the impact of gamete supplies remain. iv. a preference for gestational surrogacy the legal regime governing surrogacy in the united states differs from the corresponding regime in most jurisdictions that prohibit donor anonymity. this part will show that most states that permit surrogacy recognize or provide legal certainty only to gestational surrogacy, which is highly dependent on donor eggs. furthermore, u.s. medical practitioners endorse a preference for gestational surrogacy, believing it is a safer practice both legally and psychologically. a. legal preference most jurisdictions that prohibit gamete donor anonymity do not distinguish between traditional and gestational surrogacy. sweden,74 norway, 75 switzerland, 76 austria,77 74 g6ran hermer6n, surrogatmoderskap: varfor och varfor inte? lakartidningen january 18, 2011, at 68-69 (swed.) available at http:/ www.lakartidningen.se/07engine.php?articleld=15828 (explaining that sweden prohibits surrogacy). 75 norwegian ministry of foreign affairs, assistance to norwegians abroad (white paper) 33 (2011) (nor.), available at http://www.regjeringen.no/pages/38027779/pdfs/stm20102011001200 oenpdfs.pdf (noting under norwegian law the woman who has given birth to the child is regarded as the mother of the child and that egg donation is prohibited in norway, which means that gestational surrogacy using a donor egg is illegal); see also susan markens, 308 vol. 10: 2 prohibitions on gamete donor anonymity finland,78 and the netherlands7" prohibit or generally refuse to enforce any surrogacy arrangement. the united kingdom,"" new south wales8 i and new zealand 82 permit surrogate motherhood and the politics of reproduction 24-25 (2004). 76 schweiz[ehisches zivilgesetzbuch [zgb], code civil [cc], codice civile [cc] [civil code] dec. 18, 1998, sr 810.11, rs 810.11, art. 2(a)(k) (switz.) (defining a surrogate mother as a woman who becomes pregnant by either artificial insemination or ivf); schweizerisches zivilgesetzbuch [zgb], code civil [cc], codice civile [cc] [civil code] dec. 18, 1998, sr 810.11, rs 810.11, art. 4 (switz.) (prohibiting surrogate motherhood). see also daniel gruenbaum, foreign surrogate motherhood.* mater semper certa erat, 60 am. j. comp. l. 475, 480 n. 35 (2012). n7 allgemeines b1urgerliches gesetzbuch [abgb] [civil code] bundesgesetzblatt [bgbl] no. 118/2002, §137b (austria) (stating that the birth mother is always the legal mother). see also markens, supra note 75, at 24-25. 78 2 ch. 8(6) §, act on assisted fertility treatments (1237/2006) (fin.) (unofficial translation), available at http://www.finlex.filfillakil kaannokset/2006/en20061237.pdf (stating that finnish law prohibits assisted fertility treatment if there is reason to believe that the child will be given up for adoption, thus, effectively prohibiting surrogacy). 79 in the netherlands, the woman who gives birth to the child is the legal mother. the law contains no procedure for transferring rights from the surrogates to the intended parents. surrogacy agreements are considered against good morals and are therefore null and void. yet, courts may reduce hurdles to grant the child to the intended parents where the intended parents are both the genetic parents. machteld vonk, the role of formalised and non -formalised intentions in legal parent-child relationships in dutch law, 4 ultrecht l.rev. 117, 123124, 128-131 (2008) (neth.). 80 hugh v. mclachlan and j. kim swales, commercial surrogate motherhood and the alleged commodification of children. a defense of legally enforceable contracts, 72 law &. probs., summer 2009, at 9293; pip trowse, surrogacy is it harder to relinquish genes, 18 j. l. & med. 614, 632-33, 643-45 (2011) (austl.). 81 see generally surrogacy act 2010 no 102 (nsw) (austl.). 82 section 14 of the human assisted reproductive technology act 2004 (n.z.) (stating that surrogacy is not illegal but not enforceable); section 5 of the human assisted reproductive technology act 2004 (n.z.) (defining surrogacy as an arrangement under which a woman agrees to become pregnant for the purpose of surrendering custody of a child born as a result of the pregnancy); advisory committee on assisted reproductive technology, guidelines on surrogacy arrangements involving providers of fertility services (2007) (n.z.) (containing guidelines for providers to approve surrogacy). yet, 201:3 309 indiana health law review altruistic surrogacy arrangements but do not distinguish between gestational and traditional surrogacy. there are only two jurisdictions, the australian states of victoria and western australia, that prohibit gamete donor anonymity and distinguish between gestational and traditional surrogacy. 83 the legal landscape in the united states is different. this section will show that among the states that permit surrogacy, most provide legal certainty only to gestational surrogacy and not to traditional surrogacy. consequently, only those engaged in gestational surrogacy can be assured that the surrogacy agreement will be enforced, and parental rights will be given to the intended parents and not to the surrogate and her husband. traditional surrogacy arrangements do not benefit from the assurance of legal certainty, and stand the risk that parental rights will be given to the surrogate and her husband. federal law does not regulate either gestational or traditional surrogacy. 84 some states, whether through statute or judicial opinions, have reacted to regulate surrogacy, but will vary significantly across jurisdictions. some states prohibit surrogacy, some states are silent and their laws give no indication as to whether surrogacy is permitted, while other states allow it but usually with some restrictions.85 when a state permits surrogacy, even with the surrogate and her husband are the legal parents of the born child and the intended parents need to adopt the child. new zealand law commission, surrogacy status of the children of a surrogacy arrangement, nzlii.org (may 24, 2004), http://www.nzlii.org/nz/ other/nzlc/pp/pp54/. 83 in victoria, the patient review can only approve a surrogacy arrangement if it is satisfied the surrogate's eggs were not used, as opposed to western australia where the courts can dispense with the requirements that the surrogate consent to the parentage order and receive counseling and legal advice if she is not the genetic mother. parentage act 2004 (act) s 24 (austl.); surrogacy act 2008 (wa) s 21 (austl.); trowse, supra note 80, at 634-35. 84 spar, supra note 68, at 84. 85 see paul g. arshagouni, be fruitful and multiply by other means, if necessary: the time has come to recognize and enforce gestational surrogacy agreements, 61 depaul l. rev. 799, 805-08 (2012); radhika rao, surrogacylawin the united states: the outcome vol. 10: 2310 prohibitions on gamete donor anonymity conditions, the result is that the surrogacy agreement is enforced and the intended parents (not the surrogate) have parental rights. commentators have noted a growing preference among states for gestational surrogacy. 86 my review of state law has confirmed this and specifically has revealed that of fifteen states that permit surrogacy 8 7 only four states, namely: arkansas,88 new hampshire, 89 virginia, 90 and of ambivalence, in surrogate motherhood: international perspectives 23, 23 (rachel cook & shelley day sclater eds., hart 2003). 86 see, e.g., weldon e. havins, reproductive surrogacy at the millennium: proposed model legislation regulating "non -traditional" gestational surrogacy contracts, 31 mcgeorge l. rev. 673, 674 (2000) (arguing for the need for legislation that would recognize the important differences between gestational and traditional surrogacy); elizabeth scott, making markets in forbidden exchange: surrogacy and the politics of commodification, 72 law & contemp. probs. 109, 122-23 (2009) (describing a judicial and statutory trend toward enforcing gestational surrogacy agreements while leaving traditional arrangements in a legal void). 87 this list does not include states that are generally silent on whether surrogacy is legal or states in which there is no consensus regarding whether surrogacy is, in fact, permitted and whether the intended parents' rights would be enforced against the surrogate. specifically, tennessee is not included, which is sometimes listed as a state that allows surrogacy, because its statute is contradictory and there is no case law adjudicating surrogacy. see tenn. code. ann. § 361-102(48) (2012) (providing that in both traditional and gestational surrogacy the surrogate relinquishes rights to the intended parents, but also states that this provision will not be construed "to expressly authorize the surrogate birth process in tennessee unless otherwise approved by the courts or the general assembly"). 88 the language of the statute in arkansas appears to expressly permit only traditional surrogacy. see ark. code ann. § 9-10-201 (2012) (focusing on surrogacy through artificial insemination). yet, the focus on artificial insemination is likely the result of the technology available at the time the statute was enacted. arkansas law has been widely interpreted to recognize both traditional and gestational surrogacy. -see katherine drabiak, carole wegner, ethics, law and commercial surrogacy: a call for uniformity, 35 j. l. med. & ethics 300, 302 (2007); darra l. hofman, mama's baby, daddy's maybe: a state-by-state survey of surrogacy laws and their disparate gender impact, 35 wm. mitchell l. rev. 449, 461 (2009); council for responsible genetics, supra note 20, at 29. 3112013 indiana health law review washington 91 allow both traditional and gestational surrogacy. the remaining eleven states allow only gestational surrogacy or show a clear preference for it by granting it increased legal certainty. one approach expressly distinguishes between the two forms of surrogacy, recognizing gestational surrogacy while stating that traditional surrogacy will not be enforced. in california, case law indicates that genetic parents will first be assigned parental rights, which make a traditional surrogate the legal mother. however, when the surrogate is a gestational surrogate, with no genetic link, the intended parents, whether they are genetically related or not, are assigned parental rights. 92 furthermore, in 2012, california 89 n.h. rev. stat. ann. § 168-b:1 (2012) (defining surrogacy as "any arrangement by which a woman agrees to be impregnated using either the intended father's sperm, the intended mother's egg, or their pre-embryo with the intent that the intended parents are to become the parents of the resulting child after the child's birth."); n.h. rev. stat. ann. § 168-b:1 (2012) (providing that surrogacy agreements can be lawful). it is not clear though that new hampshire recognizes surrogacy agreements in which a donor egg was used. see n.h. rev. stat. ann. § 168-b:17 (2012) (stating that the intended mother or surrogate shall provide the ovum). see also arshagouni, supra note 85, at 807, n.46 (2012). 90 va. code ann. § 20-156 (2012) (providing that a surrogacy agreement involves a surrogate who agrees to be impregnated through assisted reproduction, which includes both ivf and artificial insemination); va. code ann. § 20-159 (2012) (provides for parental rights for the intended parents under a surrogacy agreement). 91 wash rev. code § 26.26.210 (2012) (defining surrogate parentage contracts as encompassing both gestational and traditional surrogacy); wash rev. code § 26.26.230 (2012) (forbidding only compensated surrogacy contracts); wash rev. code § 26.26.101 (2012) (providing that the woman giving birth is the mother except under a valid surrogacy agreement); wash rev. code § 26.26.260 (2012); wash rev. code § 26.09.187 (2012) (providing a multi-prong factor list to resolve custody disputes between the surrogate and the intended parents). in addition, an attorney general opinion from 1989 states that a surrogate parenting agreement is not enforceable against a surrogate mother who withdraws her consent to relinquish her child before court approval of the consent. ago 1989 no. 4 (wash.), 1989 wash. ag lexis 41. 92 johnson v. calvert, 851 p.2d 776, 782 (cal. 1993) (finding that when the surrogate who gave birth is not the genetic mother, the woman who is genetically related to the child and intended to have the 312 vol. 10:2 prohibitions on gamete donor anonymity adopted a statutory scheme, which confirms the courts' approach, and enforces only gestational surrogacy agreements. 93 similarly, in new jersey and in ohio courts have recognized gestational surrogacy agreements, while refusing to enforce traditional surrogacy agreements. 94 in illinois and north dakota, statutes achieve a similar effect, by expressly recognizing gestational surrogacy, while refusing to grant such recognition to traditional surrogacy. 95 child is the legal mother); in re marriage of moschetta, 30 cal. rptr 893, 894-95 (cal. ct. app. 1994) (refusing to enforce a surrogacy agreement where the surrogate was both the genetic and the birth mother); in re marriage of buzzanca, 72 cal. rptr. 2d 280, 282 (cal. ct. app. 1998) (holding that when the child is not genetically related to the surrogate or the intended parents, the intended parents are the legal parents). 93 see cal. fam. code §§ 7960, 7962 (deering 2012). 94 for new jersey law, see in re baby m, 537 a.2d 1227, 12341235 (n.j. 1988) (refusing to enforce a traditional surrogacy agreement); a.h.w. v. g.h.b., 772 a.2d 948, 954 (n.j. super. ct. ch. div. 2000) (allowing a gestational surrogacy agreement and granting legal parental rights where the intended parents were the genetic parents); council for responsible genetics, supra note 20, at 36. but see in re t.j.s. 16 a.3d 386, 388, 393-94 (n.j. super. ct. app. div. 2010) cert granted 207 n.j. 228, 23 a.3d 935 (2011) (finding that where a donor egg was used in a gestational surrogacy the intended mother is not the legal mother unless the baby is adopted by her). for ohio law, see f. v. d.b. 879 n.e.2d 740. 740-41 (ohio 2007) (holding that a gestational surrogacy agreement prohibiting the surrogate from asserting parental rights is valid because she has no claim to legal parentage); belsito v. clark, 644 n.e.2d 760, 762, 767 (ohio misc. 2d 1994); (holding that in a gestational surrogacy arrangement the intended parents who are also the genetic parents are the legal parents); seymour v. stotski, 611 n.e.2d 454, 454, 458 (ohio ct. app. 1992) (refusing to recognize the intended mother in a traditional surrogacy agreement as the legal mother); council for responsible genetics, supra note 20, at 37. 95 for illinois law, see 750 ill. comp. stat. 47/10 (2012) (defining gestational surrogacy as an arrangement in which "the gestational surrogate has made no genetic contribution"); 750 ill. comp. stat. 47/15 (2012) (granting the intended parents in a gestational surrogacy arrangement the status of legal parents); 750 ill. comp. stat. 47/15 (2012) (stating that "except as provided in this act, the woman who gives birth to a child is presumed to be the mother of that child for purposes of state law."). for north dakota law, see n.d. cent. code § 14-18-05 (2012) (stating that surrogacy agreements are void and unenforceable and the child born is the child of the surrogate and her husband); n.d. cent. code § 14-18-08 (2012) (stating that the child 2013 313 indiana health law review a second approach expressly recognizes gestational surrogacy, but does not illegalize traditional surrogacy. the states exercising this approach include nevada, 96 texas, 97 and utah.98 consequently, gestational surrogacy is accorded legal certainty while traditional surrogacy remains in a legal limbo, which may mean that it will not be enforced or that enforcement is uncertain. louisiana and massachusetts endorse a third approach. both expressly refuse to enforce traditional surrogacy, but at the same time, do not provide an express statement authorizing the enforcement of gestational surrogacy agreements. the statutory law of the state of louisiana expressly states that compensated traditional surrogacy is void and unenforceable, but does not address uncompensated arrangements or gestational surrogacy.99 in massachusetts, case law creates a de facto preference for gestational surrogacy, although no court has ruled directly on the enforceability of gestational surrogacy agreements. in one instance, a court ruled that where the intended born to a gestational surrogate is the child of the intended parents); council for responsible genetics, supra note 20, at 35-36. 96 in nevada unpaid gestational surrogacy using the gametes of the intended parents is recognized. see nev. rev. stat. § 126.045 (2012) (recognizing gestational surrogacy when intended parents gametes are used); kimberly m. surratt, special feature: parenthood through technology, 15 nevada lawyer 8, 8 (2007) (describing the surrogacy arrangements that are not covered under nevada law). 97 tex. fam. code § 160.755 (west 2012) (permitting courts to validate gestational agreements); tex. fam. code § 160.762 (west 2012) (stating that gestational agreements that are not validated by courts are unenforceable); tex. fam. code § 160.753 (west 2012) (when a court validates the agreement the intended parents become the legal parents); tex. fam. code § 160.754(c) (west 2012) ("the gestational agreement must require that the eggs used in the assisted reproduction procedure be retrieved from an intended parent or donor. the gestational mother's eggs may not be used in an assisted reproduction procedure"). see trowse, supra note 80, at 626-27 (emphasizing that under texas law only surrogacy arrangements in which the surrogate is not genetically related to the child will be enforced). 98 utah code ann. §78b-15-801 (lexisnexis 2012) (allowing gestational surrogacy agreements but providing that "the gestational mother's eggs may not be used in the assisted reproduction procedure."). 99 la. rev. stat. ann. § 9:2713 (2012). 314 vol. 10:2 prohibitions on gamete donor anonymity parents were the genetic parents, and the surrogate wished to relinquish her parental rights, the intended parents should be listed on the birth certificate.100 in another instance, the court refused to enforce a traditional surrogacy agreement.101 this approach, while clarifying that traditional surrogacy is illegal and inadvisable, leaves the door open to potential enforcement of gestational surrogacy. finally a fourth approach, endorsed by florida recognizes both types of surrogacy but increases the legal certainty of gestational surrogacy by imposing additional hurdles on the enforcement of traditional surrogacy. florida treats only traditional surrogacy under a pre-planned adoption agreement regime. under this regime the surrogate has a right of rescission within 24 hours after the birth of the child. 102 b. medical practioners'preference while there is some, albeit incomplete, data regarding the practice of gestational surrogacy, there is no data on the prevalence of traditional surrogacy. thus, no comprehensive empirical study has been conducted to determine whether gestational surrogacy or traditional surrogacy is the preferred practice in the united states.103 at the same time, some commentators1 04 and medical sources note that 100 see culliton v. beth isr. deaconess med. ctr. 756 n.e.2d 1133, 1135, 1137-38 (mass. 2001). 101 see r.r. v. m.h. 689 n.e.2d 790, 791,795-96,797 (mass. 1998). 102 see fla. stat. §§ 742.13; 742.15 (2012) (recognizing gestational surrogacy); fla. stat. § 63.213 (2012) (recognizing traditional surrogacy); fla. stat. § 63.213(2)(a) (2012) (requiring a right of rescission for pre-planned adoption agreements). see also trowse, supra note 80, at 627-29. 103 one study conducted in 2000 of twenty randomly selected californian surrogacy agencies showed that 30% offered only gestational surrogacy. mhairi galbraith, hugh v.mclachlan et al., commercial agencies and surrogate motherhood a transaction cost approach, 13 health care analysis 11, 20-21 (2005). 104 see, e.g., carol sanger, developing markets in baby-making' in the matter of baby m 30 harv. j.l. & gender 67 (2007) (stating that most surrogacy arrangements today involve gestational surrogacy); 2013 315 indiana health law review gestational surrogacy now dominates the practice of surrogacy.105 specifically, the american society for reproductive medicine states in its third party reproduction: a guide for patients that "[t]raditional surrogacy arrangements often are perceived as controversial [and] . . . the utilization of a gestational surrogate ... is the more common approach conducted in the united states."106 the legal preference for gestational surrogacy, apparently, has trickled to medical circles. infertility specialists believe that gestational surrogacy is legally safer. the american society for reproductive medicine's guide for patients states that traditional surrogacy is more likely to be legally complicated, while gestational surrogacy is a, legally, lower risk procedure.107 warnings regarding the increased legal risk are also passed on to infertility patients through internet fertility sources.108 at the same time, practitioners' preference for gestational surrogacy stems also from concerns that the scott, supra note 86, at 139 (stating that most surrogates today are not the genetic mothers of the born child). but ef, council for responsible genetics, supra note 20, at 6 (stating that the cost of ivf, which is needed for gestational surrogacy, compared to the cost of artificial insemination needed for traditional surrogacy, suggests that many parents will choose traditional surrogacy). 105 see, e.g., lauren fertility care, is traditional or gestational surrogacy more common?, fertility pro registry (jan. 25, 2010), http://www.fertilityproregistry.com/qa/is-traditional-or-gestationalsurrogacy-more-common (noting that "[v]ery few infertility practices do traditional surrogacy anymore . . . "). 106 american society for reproductive medicine, third party reproduction:a guide for patients, supra note 8, at 3. 107 id. 108 see e.g., gestational surrogacy v. traditional surrogacy, hubpages.com, (dec. 7, 2010), http://megscc.hubpages.com/hub/ gestationalsurrogacy-vs-traditionalsurrogacy ("traditional [sic] can be a lot more risky with the surrogate being the actual biological mother. legally she is the mother until she signs her rights away. there have been cases where the traditional surrogate has changed her mind and it became a custody battle . . . with gestational surrogacy the surrogate is not related to the child and less likely to want to keep the child. and if she did try to keep the child she really does not have much ground to stand on because she is not the biological mother."). 316 vol. 10:2 prohibitions on gamete donor anonymity emotional attachment of the surrogate will increase the likelihood that she will change her mind and refuse to deliver the child to the intended parents. these concerns apply to both gestational and traditional surrogacy.109 however, medical professionals have emphasized that these problems are more likely to arise when the surrogate is genetically related to the child.110 a recent study reviewing case-law and empirical evidence concluded that traditional surrogates are more likely to refuse to deliver the born child to the intended parents than gestational surrogates."' other medical professionals, including those describing their own clinical experience, have also reported that traditional surrogates, who are carrying their genetically related child, are more likely to experience difficulty detaching from the baby than gestational surrogate who are carrying a child who is not genetically linked to them.112 109 see vasanti jadva, clare murray et al., surrogacy: the experiences of surrogate mothers, 18 hum. reprod. 2196, 2196 (2003) (reviewing earlier literature regarding the psychological well-being of surrogates). but see id. at 2197, 2203 (concluding based on a study of thirty four traditional and gestational surrogates that surrogacy has been a generally positive experience for surrogates whether traditional or gestational). 110 american society for reproductive medicine, supra note 10, at 3 (stating that "[traditional surrogacy arrangements often are perceived as controversial with the potential to be complicated . . . psychologically"). 111 trowse, supra note 80, at 616. 112 see generally peter r. brinsden, gestational surrogacy, 9(5) hum. reprod. 483, 487 (2003) (stating that "[t]he issue which causes most concern to commissioning couples is that the host may wish to retain custody of the child. this has occurred, but is very rare, particularly in gestational surrogacy arrangements where there is no genetic link to the surrogate mother."); ciccarelli & beckman, supra note 10, at 33-34 (stating that the only study that found that a significant minority of surrogates experienced significant emotional distress when parting from the baby, 25% of the study participants, differed from other studies about the psychological effects on surrogates because, in that study, all but two of the surrogate mothers were traditional surrogates); mary e. english, andrea mechanick-braverman et al., semantic and science: the distinction between gestational carrier and traditional surrogacy options, 1 women's health issues 155, 156 (1991) (reporting that potential surrogate carriers state that while they can accept carrying a child that is biologically unrelated to 2013 317 indiana health law review v. potential ramifications of prohibition on gamete donor anonyvity on the practice of surrogacy women with certain medical problems and gay men may require both donor eggs and a surrogate in order to have a child who is genetically related to one of the partners. 113 however, prohibitions on gamete donor anonymity have played a role in creating shortages in the supplies of egg and sperm. this part posits that should prohibitions on gamete donor anonymity become common in the united states, they could contribute to creating donor gamete shortages. consequently, while individuals requiring donor eggs can now rely on the legal rights granted to gestational surrogacy in most of those states permitting such surrogacy, a prohibition affecting donor gamete supplies could greatly limit this option. in the absence of ample supplies of donor eggs, the practice of surrogacy could be affected in two ways. first, the shortages could force a return to traditional surrogacy with the accompanying legal uncertainty. second, individuals in need of surrogacy, but deterred by the legal uncertainty accompanying traditional surrogacy, could refrain from seeking surrogacy altogether or go overseas. a. return to traditional surrogacy under this first option, faced by shortages in donor eggs, individuals in need of both donor eggs and a surrogate could resort to using a traditional surrogate whose eggs would be them, they feel they would have great emotional difficulty relinquishing a child that is biologically theirs). but see olga b. a. van den akker, a longitudinal pre-pregnancy to post-delivery comparison of genetic and gestational surrogate and intended mothers: confidence and genealogy, 26 j. psychosomatic obstetrics 277, 282 (2005) (finding that the majority of surrogates' beliefs regarding the importance of a genetic link depended on whether they were traditional or gestational surrogates.). 113 see generally american society for reproductive medicine, supra note 10, at 14 (including medical issues include a congenital absence of a uterus, a prior hysterectomy, an odd shaped, such as a tshaped uterus, a repetitive pregnancy loss, or a medical condition that is incompatible with pregnancy, such as a severe heart disease, lupus, or a history of breast cancer). 318 vol. 10:2 prohibitions on gamete donor anonymity used instead of the eggs of a third party. surrogates have traditionally not been anonymous. surrogates often maintain contact with the child and intended parents after the birth of the child. furthermore, unlike parents using solely donor gametes, parents using surrogates usually tell their children about their conception method. 114 thus, prohibitions on gamete donor anonymity are unlikely to affect the availability of traditional surrogates in the way they could affect the supply of eggs. a resort to traditional surrogacy could eradicate the progress made with the advent of gestational surrogacy, particularly in terms of increasing legal certainty within the practice of surrogacy. the shift to gestational surrogacy enhanced both legal certainty and diminished concerns that surrogates will change their minds. practitioners prefer gestational surrogacy over traditional surrogacy, in part, because it offers legal certainty about parental status to all parties to the contract.115 as discussed, most states that 114 see s. golombok, c. murray et al., non-genetic and nongestational parenthood: consequences for parent-child relationships and the psychological well-being of mothers, fathers and children at age 3, 22 hum. reprod. 1918, 1921 (2006) (comparing disclosure to donor-conceived children with that of disclosure to surrogacy conceived children); andrea mechanick braverman & stephen l. corson, a comparison of oocyte donors' and gestational carriers/surrogates' attitudes toward third party reproduction 19 j. assisted reprod. & genetics 462, 465-66 (2002) (comparing attitudes toward disclosure and contact with born children between donors and surrogates); fiona maccallum et al., surrogacy: the experience of commissioning couples, 18 hum. reprod. 1334, 1339-1340 (2003) (reporting that 76% of surrogates maintained contact with the family after birth and all commissioning couples reported that they intended to tell the child about the surrogacy arrangement); v. javda et al., surrogacy families 10 years on: relationship with the surrogate, decisions over disclosure and children 's understanding of their surrogacy origins, 27 hum. reprod. 3008, 3010-11 (2012) (reporting that ten years after birth 90% of commissioning couples told the child about the surrogacy arrangement a majority of families were still in contact with the surrogate). moreover, disclosure and contact persist voluntarily and not through a government enforcement mechanism. even the few states that require surrogates to register keep all information secret. see, e.g., n.h. rev. stat. ann. §§ 168-b:21, b:24. 115 see scott, supra note 86, at 122. 2013 319 indiana health law review allow surrogacy accord legal certainty only to gestational surrogacy. state legislatures and courts granted gestational surrogacy the legal certainty they would not grant traditional surrogacy, because traditional surrogacy was perceived as more immoral. traditional surrogacy can be viewed as baby-selling, while gestational surrogacy is generally viewed as a cure for infertility. 116 lawmakers have viewed traditional surrogacy as an agreement in which the surrogate gives her child to the couple, while gestational surrogacy was viewed as an arrangement where the couple gives their child to the surrogate for gestation. therefore, the former is seen as baby selling and the latter as a curing treatment. 117 gestational surrogates are viewed differently than traditional surrogates. gestational surrogacy splits the genetic mother from the surrogate mother, thereby weakening the connection between the surrogate and the baby.118 gestational surrogates are often described as 'carriers' and not mothers. the gestational surrogate's lack of a biological connection with the child she is carrying diminishes her identity as the child's mother, and instead is viewed as providing contractual gestational services to the actual parents. 119 at the same time, traditional surrogates are seen as giving their child to another woman. therefore, traditional surrogate is perceived as having a greater claim to the child than the intended mother. 120 given the current climate and perceptions of traditional surrogacy, a forced return to traditional surrogacy due to scarcity in donor eggs is likely to increase legal uncertainty for those involved in the practice of surrogacy. furthermore, practitioners prefer gestational surrogacy not only because of the increased legal certainty, but also due to their belief 116 noa ben-asher, the curing law: on the evolution of babymaking markets, 30 cardozo l. rev. 1885, 1888, 1914 (2009); see also scott, supra note 86, at 137 (arguing that the framing of surrogacy as baby selling has lost force as traditional surrogacy has been replaced by gestational surrogacy in recent years). 117 id. at 1922. 118 see spar, supra note 68, at 79. 119 scott, supra note 86, at 140-41. 120 see spar, supra note 68, at 78. 320 vol. 10: 2 prohibitions on gamete donor anonymity that gestational surrogates are not genetically related to the baby and are less likely to change their minds and try to keep the baby. gestational surrogates also appear to share the view that they are not connected to a baby that is not genetically theirs. gestational surrogates often comment that: "[ilt's their baby, and i am just an incubator."121 the convictions of all those engaged in the practice of surrogacy, gives rise to concern that a forced resort to traditional surrogacy will increase uncertainty due to a higher number of incidents in which surrogates will refuse to relinquish the baby once it is born. b. refrain from surrogacy altogether under the second option, individuals deterred by the uncertainty accompanying traditional surrogacy may refrain from resorting to surrogacy altogether or resort to seeking surrogacy services overseas. this could result in a significant contraction of the practice of surrogacy in the united states.122 certainty is important and parties are more likely to enter agreements if they know that the law will compel enforcement. legal certainty has played a pivotal role in the practice of surrogacy; for example "california surrogacy firms regularly advertise the state's receptivity to contractual reproductive arrangements," drawing infertile people from around the world.123 faced with the sole option of traditional surrogacy with its ensuing uncertainty, individuals, for whom this is the only 121 see scott, supra note 86, at 141 (2009); claire snowdon, what makes a mother? interviews with women involved in egg donation and surrogacy, 21 birth 77, 83 (1994). 122 see generally gaia bernstein, the socio-legal acceptance of new technologies: a close look at artificial insemination, 77 wash. l. rev. 1035, 1072-1083 (2002) (describing how legal risk delayed the adoption of the technology of artificial insemination). 123 sanger, supra note 104, at 142; but cf council for responsible genetics, supra note 20, at 14-17 (demonstrating that states that did not legalize surrogacy and enforce surrogacy contracts still have a significant number of gestational surrogacy ivf cycles. for example, 5% of gestational surrogacy ivf procedures nationally are performed in new york a state that prohibits and criminalizes surrogacy). 3212013 indiana health law review option of having child genetically related to one of the partners, could be deterred from pursuing surrogacy. furthermore, eliminating the option of surrogacy enhances the pain of infertility. numerous studies record the psychological effects of infertility on both men and women, for instance, infertility causes elevated levels of anxiety and depression, grief, anger, guilt and shock, or denial. 124 surrogacy is the only option for certain individuals to have a child who is genetically related to one partner. individuals unable to have a genetically related child express sentiments such as: "[ilt is the end of the bowes family and the bowes family name. it dies with us because of me. my husband is the last of the male children in his family . . . it is the death of a dream .... "125 thus, while the discussions regarding the impact of prohibitions on gamete donor anonymity usually center on the bests interests of the children, the privacy of the intended parents, the privacy of the donors and effects on gamete supplies, the relatively unique preference for gestational surrogacy in the united states adds additional concerns. prohibitions on gamete donor anonymity can have the unintended consequences of disrupting the practice of surrogacy or enveloping it in additional uncertainty. and, 124 see, e.g., colleen m. padia, infertility takes psychological toll on patients, urology times, oct. 1, 2006, at 14 (reporting on two studies that found increased levels of anxiety and depression among infertile couples); t. wischmann et al., psychosocial characteristics of infertile couples: a study by the 'heidelberg fertility consultation service,' 16 hum. reprod. 1753, 1760 (2001) (finding a high level of anxiety and depression particularly for infertile women); see also christine dunkel-schetter & marci lobel, psychological reactions to infertility, in infertility: perspectives from stress and coping research 29, 30-35 (annette l. stanton & christine dunkel-schetter eds., 1991) (finding that the descriptive studies showed more adverse psychological effects as a result of infertility). but see christine dunkelschetter & marci lobel, psychological reactions to infertiity, in infertility: perspectives from stress and coping research 29, 5053 (annette l. stanton & christine dunkel-schetter eds., 1991) (finding that the empirical studies showed less adverse psychological effects as a result of infertility). 125 b.e. menning, the emotional needs of infertile couples, 34 fertility & sterility 313, 317 (1980). 322 vol. 10:2 prohibitions on gamete donor anonymiy although attitudes toward donor anonymity may change as the twenty-first century progresses, the reported data and potential ramifications for surrogacy advise toward great caution for those considering the implementation of an open identity system in the united states. advocates contemplating a transition to an open identity system should consider the need to combine such a shift with a change to the legal structure, which currently gives gestational surrogacy a preferred legal status as it distinguishes between traditional and gestational surrogacy.126 vi. conclusion supporters of an open identity system for egg and sperm donors are advocating that the united states join a growing international trend of jurisdictions that prohibit gamete donor anonymity. this article suggested that a shift to an open identity system should be considered with great caution. it showed that beyond the recognized interests that could be affected by a prohibition on anonymity, the potential impact of an open identity system on gamete donor supplies could affect a particular subset of infertility patients in the united states those requiring both a donor egg and a surrogate to have a child. unlike most other jurisdictions that prohibited anonymity, the practice of surrogacy in the united states is particularly vulnerable to prohibitions on gamete donor anonymity because most states that permit surrogacy recognize and accord legal certainty only to gestational surrogacy, which is highly dependent on donor eggs. the infertility industry has followed suit and also prefers gestational surrogacy to traditional surrogacy. a study of three foreign jurisdictions, 126 noa ben-asher has called for abolishing the distinction between gestational surrogacy and traditional surrogacy because the preference for gestational surrogacy excludes low-income individuals and couples who can't afford ivf and gestational surrogacy. see ben-asher, supra note 116, at 1918-1923. however, considering the role the shift toward the preferred status of gestational surrogacy has played in enhancing the legitimacy of surrogacy in the united states, a change away from this legal status is likely to involve significant complications. 2013 323 indiana health law review which implemented prohibitions on gamete donor anonymity, showed that these prohibitions played in a role in creating scarcity in donor eggs and sperm. this article posits that a prohibition on anonymity could have a similar impact on donor gamete supplies in the united states and it underscores that depletion in donor gamete supplies could destabilize the practice of surrogacy. since gestational surrogacy is highly dependent on donor eggs, it could either coerce a resort to traditional surrogacy with the enveloping legal uncertainty or it could deter infertility patients from seeking surrogacy altogether greatly contracting the practice of surrogacy. thus, this article cautions that consideration of the potential impact on the practice of surrogacy should be taken into account, among other interests, in considering a shift toward an open identity system. 324 vol. 10: 2 legal but unethical: interrogation and military health professionals legal but unethical: interrogation and military health professionals eric merriam' i. introduction .................................... 125 ii. legal and professional ethical standards ........... 133 a. international law........................ 133 b. united states domestic law....... .............. 135 c. international ethical standards........... ..... 138 d. domestic ethical standards......... .......... 139 1. professional associations.. .................. 140 2. state licensing bodies. .................. .... 142 iii. application of law and ethical standards to health professionals' activities ..... .......... 146 a. general involvement in interrogation planning and training................................. 147 1. examples: headquarters-level general interrogation plans and methods development ...... ........ 147 2. examples: guantanamo interrogation plan development.............................. 150 3. examples: general interrogation training............ 157 4. application of la w and ethical standards to general interrogation involvement........ .............. 159 a. law ................................... 159 b. ethics.................................. 161 b. direct involvement in specific interrogation............ 163 1. examples: specific interrogation planning interrogation ofmohammed al-qahtani ... ..... 164 a. law ................................... 166 b. ethics. ........................... ...... 166 2. examples: intra -interrogation consultation.......... 167 a. law ........................... ........ 173 b. ethics. ............................. ..... 175 1. examples: health examinations and interrogation monitoring. ............................... 176 1 lieutenant colonel, united states air force judge advocate general's corps; assistant professor of law, united states air force academy. the views expressed are the author's alone and do not reflect the views of the united states air force or department of defense. 124 indiana health law review vol. 11:1 a. law................................... 178 b ethics.................................. 178 c. general medical care ................... ..... 180 1. examples: failure to identify or report evidence of in terroga tion -related ab use ................. 181 a. law................................... 184 b. ethics. .................................. 186 2. examples: concealing interrogation-related injuries.................................. 186 a. law .................................. 187 b. ethics.................................. 187 3. examples: withholding care to obtain cooperation ............................... 188 a. law .................................. 191 b. ethics.................................. 191 4. examples: providing care for the purpose of furthering interrogation.......... ....... 192 a. law ................................... 194 b. ethics.................................. 195 5. examples: forced feeding............. ...... 195 a. law................................... 197 6. examples: sharing medical information with interrogation teams ................... ..... 199 a. law................................... 201 b. ethics................................. 201 d. conclusion ............................ ..... 202 iv. conclusion: the impact of the law-ethics divide ......................................... 203 a. the law-ethics gap leaves mhps unempowered to protect detainees .............................. 204 1. military medical comm unity is subordinate to operational actors................. ........... 206 2. professional dual loyalty........... ........... 209 b. the law-ethics gap cedes too much power to professional health associations............... 212 c the law-ethics gap may exclude health professionals from interrogation process ................ .... 214 d. the law-ethics gap divide harms mhps .... .... 216 1. professional risks ..................... ..... 217 a. health professional risks ............ ..... 217 legal but unethical b. military professional risks ........... ..... 218 1. personal risks ............................... 219 a. criminal liability .......................... 219 b civil/tort liability?...................... 221 e. conclusion ........................... ...... 221 i. introduction united states military health professionals ("mhps"),2 including medical doctors and psychologists who have 2 unless otherwise specified, the term hp refers to military medical and psychology providers. of particular concern in this article are military physicians, including psychiatrists, and clinical psychologists, in part because their activities have been the greatest subject of debate, and because their professional organizations have been most vocal in articulating ethical standards in this area. a department of defense ("dod") regulation addressing hps' participation in interrogation-related activities defines "health professional" more broadly: an individual who has received special training or education in a health-related field and who performs services in or for the department of defense in that field. a health-related field may include administration, direct provision of patient care, or ancillary or other support services. health care personnel include, but are not limited to, individuals licensed, certified, or registered by a government agency or professional organization to provide specific health services. u.s. dep't of def., no. 2310.08e, department of defense instruction: medical program support for detainee operations § 3.3 (june 6, 2006), [hereinafter dodi 2310.08e], available at http://www.dtic.mil/whs/directives/corres/pdf/231008p.pdf other "health personnel," such as physician assistants, mental health technicians, nurses, and medics, are specifically identified where discussed. though the interrogation-related actions of non-military medical providers, especially those of the central intelligence agency's office of medical services, are germane to questions regarding interrogation-related activities of medical personnel, this article focuses on military medical providers. because of the greater complexity of military actions vis-a-vis the law of war, the unique position of military providers who may not refuse lawful orders, unlike civilian medical 2014 125 indiana health law review served at military detention facilities in afghanistan, guantanamo bay, cuba (guantanamo), and iraq, have been labeled "torturers" or war criminals for their interrogationrelated activities. 3 detractors have likened health professionals ("hps") related to the interrogations at guantanamo to nazi war criminals: the [military and cia] health personnel who participated fulfilled the same role as the nazi doctors by their decisions based on medicine, physiology, or psychology recommending or deciding on additional applications of interrogation regimens or combinations that providers who can object to participation in objectionable activities by refusing or quitting, and the relatively greater amount of publicly available information regarding their activities, especially compared with non-mhps at other, non-military-run, detention facilities. 3 see, e.g., peter slevin & joe stephens, detainees' medical les shared; guantanamo interrogators' access criticized, wash. post, june 10, 2004, at al ("steven h. miles, a professor of bioethics at the university of minnesota, said that using [health] information in interrogations of detainees would be a 'clear-cut violation' of the geneva conventions."); nat hentoff, war crimes by doctors and psychologists, orangeburg times and democrat (oct. 1, 2009) http://thetandd.com/news/opinion/war-crimes-by-doctors-andpsychologists/articlede63ff47-7106-56cd-bel4-83397d832b7e.html (last visited nov. 26, 2013) (wondering whether professional associations will call for investigation of 'health professionals' actual participation in war crimes under the convention against torture and other cruel, inhuman or degrading treatment or punishment-as well as the geneva conventions and the u.s. torture act"); steven h. miles, oath betrayed: america's torture doctors ix-x, 167 (2009) (asking "where were the doctors at abu ghraib?" and asserting that "[tiorturers need medical accomplices"); david brennan, torture of guantinamo detainees with the complicity of medical health personnel: the case for accountability and providing a forum for redress for these international wrongs, 45 u.s.f. l. rev. 1005, 1006 (2011) [hereinafter brennan, torture of detainees] ("direct participation by medical health personnel in these activities constituted gross violations of international and domestic law, as well as their specific ethical and professional obligations."). vol. 11:1126 legal but unethical interrogators could or should use, including the point at which interrogation had to stop.4 even hps who merely provided health care for detainees5 have not escaped condemnation, with critics charging "even those health professionals who sought to restrict themselves to clinical roles and steered clear of interrogation support became part of the machinery of torturd' and "became enablers of torture by providing medical care in an environment where torture was taking place."6 commentators suggest, quite correctly, that by virtue of their professions and proximity, hps bear, or should bear, heightened responsibility to protect against interrogationrelated abuses. 7 however, critics have suggested, 4 brennan, torture of detainees, supra note 3, at 1033. the comparison to nazi doctors will be examined below. 5 understanding that terms to describe individuals who are held against their will in the context of conflict-such as "prisoner," "captive," "retained personnel," and the like-have significance in the context of international law, the term "detainee" will be used to refer generally to all types of individuals detained for an extended period of time (not temporary battlefield detentions) by the united states in relation to its post-9/11wars in iraq, afghanistan, and against al qaeda and affiliated terrorist networks. 6 farnoosh hashemian et al., broken laws, broken lives: medical evidence of torture by us personnel and its impact, physicians for human rights 85-86 (june 2008), available at https://s3.amazonaws.com/phrreports/brokenlaws_14.pdf (emphases added). the tenuous factual nature of this assertion, not to mention the legally unsupportable claim that by providing medical care to detainees hps were somehow responsible for the interrogation abuses, is demonstrated by physicians for human rights' ("phr") own acknowledgment: "phr has no information about whether physicians or other health personnel reported torture to authorities, but they surely did not intervene to stop torture when they were in its midst or were examining those subjected to it." id. 7 see, e.g., miles, supra note 3; leonard s. rubenstein, complicity and the illusion of beneficence, in forced feedings, and the role of health professionals (ryan goodman & mindy jane roseman eds. 2009); stephanie erin brewer & jean maria arrigo, places that medical ethics can't 1nd: preliminary observations on why health professionals fail to stop torture in overseas counterterrorism operations, in forced feedings, and the role of health professionals 1 (ryan goodman & mindy jane roseman eds. 2014 127 indiana health law review sometimes by inference and sometimes explicitly, that that heightened responsibility is imposed on hps by both legal and professional ethical standards and some discussions have failed clearly to distinguish between legal and ethical standards, sometimes conflating the two.8 for example, the international committee for the red cross ("icrc") mixed applicable legal and ethical standards when it reported "the interrogation process is contrary to international law [to the extent that] participation of health personnel in such a process is contrary to international standards of medical ethics."9 2009) ("[tlhe health community struggles to understand how medical professionals have stood by during episodes of severe detainees abuse in u.s.-controlled detention centers. . . ."). some critics may be arguing, justifiably, that, based on theories of accessory, accomplice, or conspiratorial liability, the circle of liable persons is larger than the people in the room during the interrogations, reminding us to add hps to a list that includes commanders, civilian leaders, and attorneys who authorized illegal activities. the purpose of this article is to demonstrate such secondary liability is the only real constraint on hps that law imposes-none directly addresses hps' activities. 8 see, e.g., brennan, torture of detainees, supra note 3, at 1006 ("direct participation by medical health personnel in these activities constituted gross violations of international and domestic law, as well as their specific ethical and professional obligations.") and at 1041-43 (arguing olc's memoranda regarding legality of interrogation methods should have addressed "medical health personnel's potential culpability" under "recognized codified principles" such as the 1947 nuremberg code; 1948 declaration of geneva; universal declaration of human rights; and world medical association's ("wma") international code of medical ethics, as incorporated in the wma's 1964 declaration of helsinki, wma's 1975 declaration of tokyo, and wma's 2005 medical ethics manual, without distinguishing or explaining these instruments' varying legal effects); miles, supra note 3, at xii ("the international laws and medical ethics codes pertaining to torture are not finicky rules. ... [they] are breathing expressions of global moral aspiration.") and at 5 (quoting both the convention against torture and wma's "guidelines for medical doctors concerning torture and other cruel, inhuman or degrading treatment or punishment in relation to detention and imprisonment" as support for argument that torture is a "crime against humanity"). 9 icrc report on the treatment of fourteen 'high value detainees" in cia custody, int'l comm. of the red cross 23 (2007) [hereinafter icrc report of 20071, available at http://www.nybooks.com/media/doc/2010/04/22/icrc-report.pdf. 128 vol. 11:1 legal but unethical much of the post-9/11 debate and scholarship regarding mhps' detainee-related activities have occurred in the professional medical ethics arenas, with comparatively limited focused analysis on international and domestic legal regimes specifically affecting mhps' activities.10 10 see, e.g., miles, supra note 3; jonathan h. marks, doctors as pawns? law and medical ethics at guantdnamo bay, 37 seton hall l. rev. 711 (2007) [hereinafter marks, doctors as pawns]; jonathan h. marks, looking back, thinking ahead.* the complicity of health professionals in detainee abuse, in interrogations, forced feedings, and the role of health professionals 30 (ryan goodman & mindy jane roseman eds. 2009) [hereinafter marks, looking back]; rubenstein, supra note 7. as will be demonstrated in this article, this focus on ethics is perhaps necessary; specific lawis sparse. the relative absence of academic assessment should perhaps not be surprising, as it follows apparent practitioner oversight of the many laws directly affecting medical personnel; the several iterations of legal memoranda approving "enhanced interrogation" failed to address legal considerations governing medical personnel activities in hostilities and interrogation. see, e.g., memo from assistant attorney general jay bybee to white house counsel alberto gonzales, standards of conduct for interrogation under 18 u.s.c. §§ 2340-2340a (aug. 1, 2002) [hereinafter bybee memo to gonzales] (providing no analysis of law and ethical standards governing participation by hps). in fact, the only mention of medical personnel in these memoranda was to require their involvement, thus pulling medical personnel into potentially illegal activities without discussing whether there were legal issues specific to them. see, e.g., memorandum from donald rumsfeld on counterresistance techniques in the war on terrorism to the commander, u.s. southern command (apr. 16, 2003), [hereinafter rumsfeld approval memorandum of april 20031, available at http://www.torturingdemocracy.org/documents/20030416.pdf, memorandum from steven g. bradbury, principal deputy assistant attorney general, office of legal counsel, u.s. dep't of justice, to john a. rizzo, senior deputy gen. counsel, central intelligence agency, re: application of 18 u.s.c. §§ 2340-2340a to certain techniques that may be used in the interrogation of a high value al qaeda detainee 6-8 (may 10, 2005) [hereinafter bradbury memo of may 2005]. bradbury documents the cia's office of medical services involvement in evaluating detainees before any enhanced technique is authorized in order to ensure that the detainee is not likely to suffer any severe physical or mental pain or suffering as a result of interrogation. id the field is not completely devoid of valuable legal analysis and contribution. while the author disagrees with some of their arguments and conclusions, the thoughtful and detailed scholarship of professor jonathan h. marks and sometimes co-author dr. gregg bloche in this 2014 129 indiana health law review the purpose of this article is to demonstrate that while professional ethical standards provided--or evolved to provide-increased responsibility on mhps for their interrogation-related activities, international and domestic law did not. to be clear, this article does not argue that no law applied to or limited mhps' interrogation related activities. indeed, there is significant international and domestic law regarding interrogation of detainees. however, the law generally does not treat hps differently than non-hps, either by identifying them as a separate class of actors or by substantively and specifically prescribing or proscribing hps' interrogation-related activities. thus, professional ethical standards prohibit mhps from engaging in a wide range of interrogationrelated activities that international and domestic law does not, and the law generally imposes no greater burden or responsibility for protecting human rights on mhps than on non-hp service members. while this gap between law and ethics is occasionally due to an actual conflict between legal and ethical standards, more often it is because law is silent regarding participation by hps in the type of interrogationrelated activity at issue. further, in limited areas where law does prescribe health-specific interrogation-related activities, such as medical experimentation on detainees, the facts alleged by critics do not constitute violations of the law by mhps. with the exception of a brief assessment of possible secondary liability for hps, the analysis and conclusions do not rely on whether "enhanced interrogation techniques" constituted torture or were illegal and this paper does not attempt to resolve the dispute." further, this paper makes area is noteworthy. see, e.g., m.g. bloche & j.h. marks, when doctors go to war, 352 new eng. j. med. 3, 4 (2004) [hereinafter bloche & marks, doctors go to war; jonathan h. marks, doctors as pawns, supra note 10; and marks, looking back, supra note 10. 11 in fact, for the purpose of this article, one may agree with the conclusions of many commentators-and as was recently learned, the opinion of a senior advisor in the bush administration's state department-that several of the so-called "enhanced interrogation techniques" employed by military personnel, including waterboarding, stress positions, cramped confinement, sleep deprivation, and nudity, 130 vol. 11:1 legal but unethical no attempt to resolve whether various international laws were applicable to all types of detainees in all military detention locations.12 not all laws discussed in this paper applied to all detainees in all locations, but so long as a law arguably applied to some military detainees in some locations, it is included. also, the paper does not attempt to determine conclusively whether mhps actually violated the law, a point rendered somewhat moot domestically by the criminal and civil absolution provided in the military commissions act of 2006.13 rather, this paper addresses the broader question of whether law, as opposed to ethical standards, actually prohibits the types of interrogationrelated conduct in which mhps engaged that give rise to allegations of malfeasance. this paper provides some specific instances of the type of misconduct critics allege was unlawful or improper, but only to illustrate the activity, rather than to serve as a platform for applying law and ethics to a specific set of facts. finally, though there are many aspects of hps' involvement in detainee operations that are addressed by international and domestic law, including general sanitation, food quality, and security concerns at detention facilities, this paper addresses only mhps' interrogation -related activities. mhps are associated with detainee interrogation in a variety of ways, with activities covering a spectrum from direct involvement in specific interrogation sessions to unrelated medical care for detainees who also happen to be subject to interrogation. activities along this spectrum constitute torture or cruel, inhuman, or degrading treatment under international law, united states domestic law, or both. see draft memorandum from philip d. zelikow, the mccain amendment and u.s. obligations under article 16 of the convention against torture 6 (feb. 15, 2006), available at http://www2.gwu.edul-nsarchiv/news/ 20120403/. that memorandum addressed torture after the so-called "mccain amendment." id. 12 for example, though it will be briefly referenced below, the paper does not resolve whether detainees in guantanamo were entitled to protections of geneva conventions other than common article 3, or whether some detainees in iraq were entitled to them while others were not. 13 military commissions act of 2006, pub. l. no. 109-366, 120 stat. 2600 (2006). 2014 131 indiana health law review have been criticized as violating legal and professional ethical standards. 14 this article groups these activities in three ways: 1) general interrogation involvement, including planning and methods development and training; 2) specific interrogation involvement, including specific interrogation planning, specific intra-interrogation consulting, monitoring during interrogation sessions, preand post-interrogation assessments, and alleged interrogation-related medical experiments; and 3) general medical and psychological care for interrogated detainees that is generally unrelated to interrogation but that nevertheless gives rise to allegations of interrogation-related misconduct, including allegations of failure to report and concealing abuse, withholding care to obtain information, providing care for the purpose of furthering interrogation, forced feeding, and sharing medical information with interrogators. just as mhps' interrogation-related activities occupy a spectrum, so too do the variety of instruments that could proscribe or prescribe those activities exist along a spectrum ranging from legal (including treaty, customary international law, and domestic statutes and regulations) to ethical standards pronounced by various professional associations. these types of instruments have varying effects, with treaties imposing contractual obligations on states, other international and domestic law imposing criminal or civil liability on individuals, and ethical standards providing powerful personal and professional incentives for compliance, including possible impact on licensing and professional censure, or perhaps constituting evidence of professional misconduct giving rise to civil liability. 14 see, e.g., brennan, torture of detainees, supra note 3, at 1006 ("direct participation by medical health personnel in these activities constituted gross violations of international and domestic law, as well as their specific ethical and professional obligations."); hashemian et al., supra note 6, at 7 (asserting that "medical personnel played a role in facilitating torture and ill-treatment in all three theatres of operations through the monitoring of abuse during interrogations, providing medical information to interrogators, denying medical care, and failing to take action to stop and/or document detainee abuse."); miles, supra note 3; hentoff, supra note 3; marks, doctors as pawns, supra note 10. 132 vol. 11:1 legal but unethical section ii is a brief summary of the international and domestic law and professional ethical standards affecting mhps' interrogation-related activities. in section iii, the law and ethical standards are applied to the types of interrogation-related activities involving mhps about which critics have complained, illustrating the significant divide between legal prohibitions and professional ethical standards. exploring these various instruments will demonstrate the law does little to proscribe hps' interrogation-related activities or establish professionals as guardians of human rights in the interrogation, while professional ethics clearly do. the paper concludes with a brief discussion of why the lack of legal prohibitions in the face of significant and specific ethical standards is problematic. ii. legal and professional ethical standards a. international law the primary sources of international law that could potentially bear on medical providers' interrogation-related activities during armed conflict are the following: the geneva conventions, including article 75 of optional protocol 1; 15 the convention against torture and other cruel, inhuman or degrading treatment or punishment 15 geneva convention relative to the amelioration of the condition of the wounded and sick in armed forces in the field, aug. 12, 1949, 6 u.s.t. 3114, 75 u.n.t.s. 31 [hereinafter geneva ii; geneva convention relative to the amelioration of the condition of wounded, sick and shipwrecked members of armed forces at sea, aug. 12, 1949, 6 u.s.t. 3217, 75 u.n.t.s. 85 [hereinafter geneva ii; geneva convention relative to the treatment of prisoners of war, aug. 12, 1949, 6 u.s.t. 3316, 75 u.n.t.s. 135 [hereinafter geneva iii]; geneva convention relative to the protection of civilian persons in time of war, aug. 12, 1949, 6 u.s.t. 3516, 75 u.n.t.s. 287 [hereinafter geneva iv]; and protocol additional to the geneva conventions of 12 august 1949, and relating to the protection of victims of international armed conflicts (protocol i), june 8, 1977, 1125 u.n.t.s. 3 [hereinafter protocol i. 1332014 indiana health law review ("convention against torture" or "cat'); 16 and the nuremberg code.' 7 as will be demonstrated below, while 16 g.a. res. 39/46, u.n. doc. a/res/39/46 (dec. 10, 1984) [hereinafter convention against torture or cat]. 17 the nuremberg code (1947), available athttp://www.cirp.org/ library/ethics/nuremberg/ (last updated june 9, 2002) [hereinafter nuremberg code]. often cited by commentators arguing that united states mhps violated the law in gwot interrogations, the nuremberg code is not a "code" as lawyers understand the term, but is actually dicta in the judgment of the court in the post-world war ii trial of nazi doctors. see, e.g., brennan, torture ofdetainees, supra note 3, at 1040 (arguing that "viewed through the nuremberg code," united states hps violated the law). there is significant debate regarding the legal effect of the nuremberg code. see sharon perley et al., the nuremberg code: an international overview, in the nazi doctors and the nuremberg code: human rights in human experimentation 149 (george j. annas & michael a. grodin ed., oxford univ. press 1992); george j. annas et al., informed consent to human experimentation: the subject's dilemma 122 (1977). most united states courts addressing the status of the nuremberg code and declaration of helsinki have concluded they are not binding and create no cause of action. see, e.g., ammend v. bioport, inc., 322 f. supp. 2d 848, 872 (w.d. mich. 2004) (finding no supreme court precedent establishing the nuremberg code or declaration of helsinki as a constitutional right and holding that there is no private right of action for an alleged violation of international law for the protection of human research subjects under the declaration of helsinki and the nuremberg code); white v. paulsen, 997 f. supp. 1380, 1383 (e.d. wash. 1998); and hoover v. w. va. dep't of health and human res., 984 f. supp. 978 (s.d. w. va. 1997), affd 129 f.3d 1259 (4th cir. 1997). however, the norms articulated in the nuremberg code (and later, the declaration of helsinki, discussed below) clearly constitute customary international law. one united states court found the nuremberg trials' "authorizing documents" and judgments established legal principles that became the "bedrock norms of international law." see, e.g., abdullahi v. pfizer, inc., 562 f.3d 163, 177-79 (2d cir. 2009) (noting that at least eighty-three other countries had incorporated the declaration of helsinki into their laws regulating informed consent of human subjects and concluding "the sources on which our government relied in outlawing non-consensual human medical experimentation were the nuremberg code and the declaration of helsinki, which suggests the government conceived of these sources' articulation of the norm as a legal obligation."). several additional regional and international instruments that address the alleged underlying misconduct at issue here-especially torture-will not be presented because they are inapplicable to the regions at issue or because their prohibitions parrot, in substance and 134 vol. 11:1 legal but unethical these laws address treatment of detainees and interrogation, they do not specifically prescribe or proscribe health professionals'behavior as it relates to interrogation and, therefore, fail to sufficiently regulate such conduct.' 8 b. united states domestic law a variety of united states domestic laws potentially apply to mhps' interrogation-related activities, including form, the instruments that are discussed here. see, e.g., american convention on human rights, nov. 22, 1969, art. 5, 1144 u.n.t.s. 123 ("no one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment."); inter-american convention to prevent and punish torture, o.a.s.t.s. no. 67 (entered into force feb. 28, 1987), reprinted in basic documents pertaining to human rights in the interamerican system, oea/ser.l/v/ii.82 doc. 6 rev. 1 at 83 (1992); european convention for the protection of human rights and fundamental freedoms, nov. 4, 1950, art. 3, 213 u.n.t.s. 221, as amended by protocols nos. 3, 5, 8, and 11 (entered into force sept. 21, 1970, dec. 20, 1971, jan. 1, 1990, and nov. 1, 1998) ("no one shall be subjected to torture or to inhumane or degrading treatment or punishment."); european convention for the prevention of torture and inhuman or degrading treatment or punishment, e.t.s. 126 (entered into force feb. 1, 1989); african [banjul] charter on human and peoples' rights, adopted june 27, 1981, art. 5, oau doc. cab/leg/67/3 rev. 5, 21 i.l.m. 58 (1982) (entered into force oct. 21, 1986) ("all forms of exploitation and degradation of man particularly slavery, slave trade, torture, cruel, inhuman or degrading punishment and treatment shall be prohibited."); and revised arab charter on human rights, may 22, 2004, art. 8.1 (entered into force march 15, 2008), reprinted in 12 int'l h.r. rep. 893 (2005) ("no one shall be subjected to physical or psychological torture or to cruel, degrading, humiliating or inhuman treatment."). 18 because this article applies available law to the types of military professionals' interrogation-related activities alleged to be improper, rather than analyzing specific cases, if a particular law was relevant to any interrogations of military detainees in the global war on terror ("gwot"), it is considered presented here. 2014 135 indiana health law review federal statutes and regulations. 19 some of these measures are the united states' implementation of treaty obligations, while others are independently undertaken by the united states. relevant domestic laws include the following: the so-called anti-torture statute;20 war crimes act ("wca");21 detainee treatment act of 2005 ("dta"); 22 military commissions act of 2006 ("mca");23 the uniform code of military justice ("ucmj");24 and various department of defense ("dod") regulations. 25 19 various states including new york, california, and massachusetts have also considered torture-related activities of hps. see tara a. lewis, did cia doctors experiment on terror suspects, newsweek (jun. 24, 2010, 5:00 am), http://www.thedailybeast.com/ newsweek/2010/06/24/did-cia-doctors-experiment-on-torturesuspects.html. though clearly relevant to individual hps, a state survey is beyond the scope of this article, which is intended to apply all united states mhps. 20 18 u.s.c. §§ 2340-2340a (2013). 21 18 u.s.c. § 2441 (2013). 22 the detainee treatment act is actually identically presented in two different pieces of enacted legislation: the department of defense, emergency supplemental appropriations to address hurricanes in the gulf of mexico, and pandemic influenza act, pub. l. 109-148 (2005) and the national defense authorization act for fiscal year 2006, pub. l. no. 109-63, 3136, 3475-76 (2006). 23 military commissions act of 2006, pub. l. no. 109-366, 120 stat. 2600 (2006). 24 10 u.s.c. §§ 801-946. the uniform code of military justice has no specific provisions criminalizing specific behavior by mhps, but has several provisions that could be used to prosecute mhps-as well as any service member-for interrogation-related offenses, including articles 92 (failure to obey lawful orders and regulations), 93 (maltreatment of subordinates), 128 (assault offenses), and 134 ("disorders and neglects" to the prejudice of good order and discipline in the armed forces; conduct of a nature to bring discredit upon the armed forces). 25 regulations specifically addressing mhps' interrogation-related activities include dodi 2310.08e, supra note 2; enemy prisoners of war, retained personnel, civilian internees and other detainees, ar 190-8 (oct. 1 1997); and the two army "field manuals": u.s. dep't of the army, field manual 34-52: intelligence interrogation (1997) [hereinafter 1997 field manual] was replaced by the u.s. dep't of the army, field manual 2-22.3: human intelligence collector operations (2006) [hereinafter 2006 field manual]. 136 vol. 11:1 legal but unethical of direct relevance to this paper, dodi 2310.08e was the dod's late attempt to clarify hps' roles in detainee treatment. this instruction addressed several important policy principles in the debate regarding hps' involvement in detention-based interrogation activities. regarding hps' general duty to detainees, including matters related to interrogation, it states: 4.1.1. health care personnel have a duty in all matters affecting the physical and mental health of detainees . . . to uphold the humane treatment of detainees and to ensure that no individual in the custody or under the physical control of the department of defense, regardless of nationality or physical location, shall be subject to cruel, inhuman, or degrading treatment or punishment, in accordance with and as definedin us. law. 4.1.2. health care personnel charged with the medical care of detainees have a duty to protect detainees' physical and mental health additional regulations include dod directive ("dodd") 6025.18-r, dod health information privacy regulation (2003); dodd 2310.1, dod program for enemy prisoners of war (epow) and other detainees (1994); dodd 3115.09, dod intelligence interrogations, detainee debriefings, and tactical questioning (2008); dodd 5100.77, dod law of war program, (1998); dodd 3216.2, protection of human subjects and adherence to ethical standards in dod-supported research (2002) [hereinafter dodd 3216.21; health affairs policy 05-006, medical program principles and procedures for the protection and treatment of detainees in the custody of the armed forces of the united states (2005), withdrawn, dodi 2310.08e, supra note 2, § 1(a) [hereinafter ha policy 05-0061; health affairs policy 05-019, training for health care providers in detainee operations (2005); j. chiefs of staff, jp 3-63, joint doctrine for detainee operations (2008); j. chiefs of staff, jp 4-02, doctrine for health service support in joint operations (2006); dep't of the army, da g-2, interim intelligence interrogation policy (2007); 2006 field manual; u.s. dep't of the army, field manual 3-19.40: internment/resettlement operations (2007). 2014 137 indiana health law review and provide appropriate treatment for disease. 4.1.4. health care personnel, whether or not in a professional provider-patient treatment relationship, shall not apply their knowledge and skills in a manner that is not in accordance with applicable la w.... 4.1.5. health care personnel shall not certify, or participate in the certification of, the fitness of detainees for any form of treatment or punishment that is not in accordance with applicable law, or participate in any way in the administration of any such treatment or punishment. 26 c. international ethical standards while few laws specifically relate to healthcare personnel and their interrogation-related activities, a number of professional ethical standards from international and domestic bodies directly relate to the interrogationrelated activities of mhps. 27 ethical standards are not 26 dodi 2310.08e, supra note 2, § 4.1.1-4.1.5. dodi 2310.08e also contains the clearest articulation of the dod's view that the appropriate way to address medical provider participation in interrogation was to bifurcate all activities into two categories. see id. § 4.3 ("health care personnel engaged in a professional provider-patient treatment relationship with detainees shall not participate in detainee-related activities for purposes other than health care.") 27 see, e.g., g.a. res. 37/194, annex, u.n. doc. a/res/37/194 (dec. 18, 1982) [hereinafter u.n. principles of medical ethics], available at http://www.wma.net/en/30publications/lopolicies/b3/index.html.pdf, world med. ass'n, wma declaration of helsinki-ethical principles for medical research involving human subjects, available at http://www.wma.net/en/30publications/1opolicies/b3/ [hereinafter declaration of helsinki]; declaration of tokyo (1975): guidelines for physicians concerning torture and other cruel, inhuman or degrading treatment or punishment in relation to detention and imprisonment, world med. ass'n (1975) [hereinafter declaration of tokyo], available at http://www.cirp.org/library/ethics/ 138 vol. 11:1 legal but unethical "law," but can influence hps' personal and professional behavior in meaningful ways. nevertheless, as argued in section iv, where ethical standards are unsupported by law, they are insufficient to the task of establishing hps as guardians of human rights in interrogation settings and the resulting divide between law and ethics has negative consequences. d. domestic ethical standards like international professional associations, domestic professional associations do not have the power to enforce their ethical standards. the most professional associations can do to discipline a member is to revoke membership in the association, and membership is not required to practice (much like membership in the american bar association is not required practice law).28 state licensing boards directly determine whether a physician, psychiatrist, or psychologist may practice, and thus they hold the only direct enforcement power when addressing professional ethics issues. however, domestic ethical standards are nevertheless influential and have the ability to persuade hps to act in accordance with them. some state licensing boards enforce domestic professional associations' ethical standards, rendering domestic standards perhaps more influential than international standards in terms of their ability to guide individual hps' actions. additionally, tokyo; world med. ass'n, revised declaration of tokyo, available at http://www.un.org/documents/ga/res/37/a37rl94.htm; wma regulations in times of armed conflict and other situations of violence, world med. ass'n, para. 2 (2006) [hereinafter regulations in times of armed conflict], available at http://www.wma.net/ en/30publications/l0policies/a20/ (last visited dec. 23, 2013). in this article, the term "standards" applies to all "codes," regulations, and pronouncements of international and domestic bodies governing healthcare practice. 28 see ty alper, the role of state medical boards in regulating physician participation in executions, 95 j. med. licensure and discipline, no. 3, 2009, at 16, 18 (also noting only 20% of doctors in the united states are members of the american medical association ("ama")), available at http://papers.ssrn.com/sol3/papers.cfm? abstract id=1544623. 2014 139 indiana health law review professional associations' standards are routinely cited by ethicists and hps, which demonstrates their importance. 1. professional associations domestic ethical standards relevant to mhps' interrogation-related activities issued by professional associations include the american medical association's ("ama") ethical guidelines; 29 a position paper issued by the american psychiatric association ("2006 position statement"); 30 and various positions articulated by the american psychological association ("apa"), including its report of the american psychological association presidential task force on psychological ethics and national security,"31 resolution against torture and cruel, 29 the ama's guidelines generally conform to the wma's declaration of helsinki and the declaration of tokyo. ama code of medical ethics, opinion 2.067, torture [hereinafter ama opinion 2.0671 and ama code of medical ethics, opinion 2.068, physician participation in interrogation [hereinafter ama opinion 2.0681, both available at http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics.page?. the ama's prohibition on physician participation in torture predates the gwot, but the organization did not formally take a position on the role of physicians in interrogation until 2006, when it promulgated new ethical guidelines stating "[p]hysicians must neither conduct nor directly participate in, or monitor an interrogation, because a role as physician-interrogator undermines the physician's role as healer and thereby erodes trust in the individual physician-interrogator and in the medical profession." 30 position statement on psychiatric participation in interrogation of detainees, am. psychiatric ass'n(2006), available at http://www.psychiatry.org/file%20library/advocacy%20and% 20newsroom/position%20statements/ps2006_interrogation.pdf [hereinafter 2006 position statement]. 31 report of the american psychological association presidential task force on psychological ethics and national security, am. psychological ass'n (2005), available at http://www.apa.org/pubs/info/reports/pens.pdf [hereinafter pens task force report]. the pens task force has been widely criticized, in part because a significant number of its members were associated with military or national security apparatus. see, e.g., tara mckelvey, first do some harm, the american prospect, sept. 1, 2005, http://www.prospect.org/web/printfriendly-view.ww?id=10110; brad olson et al., the ethics of interrogation and the american psychological vol. 11:1140 legal but unethical inhuman, and degrading treatment ("2006 apa resolution against torture"),32 and the 2008 apa resolution against torture. 3 association: a critique of policy and process, 3 phil. ethics and human. med. (2008), available at http://www.peh-med.com/content/3/1/3 (a thorough critique of the process and substance of the pens task force report). one recommendation specifically allowed participation by psychologists in activities involving interrogations where "national security issues" were involved. id. at 7. proscriptions against psychologists' participation in abusive interrogation were not defined by reference to international law, but rather tied to "applicable" united states rules and regulations as "developed and refined" since 9/11, thus tying psychologists' ethical obligations to the administration's interpretation of the applicable law. marks, doctors as pawns, supra note 10, at 723. 32 resolution against torture and cruel, inhuman, and degrading treatment or punishment, am. psychological ass'n (2006), available at http://www.apa.org/about/policy/chapter3.aspx#torture-punishment [hereinafter 2006 apa resolution against torture], under which psychologists must not "knowingly engage in, tolerate, direct, support, advise, or offer training" in torture, cruel, inhuman, and degrading treatment. in describing the 2006 apa resolution against torture, one commentator observed, "these regulations require psychologists to obey the laws that bind us all. beyond that, psychologists have only their consciences as a guide." marks, doctors as pawns, supra note 10, at 726-27. 33 amendment to the reaffirmation of the american psychological association position against torture and other cruel, inhuman, or degrading treatment or punishment and its application to individuals defined in the united states code as "enemy combatants", am. psychological ass'n (2008) [hereinafter 2008 apa resolution against torture], available at http://www.apa.org/news/press/statements/ethics-statement-torture.pdf. the 2008 apa resolution against torture modified the 2006 apa resolution against torture and clearly tied its prohibitions both to international law and to principles of professional ethics, declaring those sources required an absolute prohibition on the following techniques: mock executions; water-boarding or any other form of simulated drowning or suffocation; sexual humiliation; rape; cultural or religious humiliation; exploitation of fears, phobias or psychopathology; induced hypothermia; the use of psychotropic drugs or mindaltering substances; hooding; forced nakedness; stress positions; the use of dogs to threaten or intimidate; physical assault including slapping or shaking; 2014 141 indiana health law review 2. state licensing bodies state licensing bodies, typically referred to as "boards," are the only organizations with authority to directly enforce professional standards of hps. the professional associations' ethical policies identified above ostensibly enjoy their greatest enforcement power, although it is indirect, in states where licensing boards are permitted to take action against hps for violations of the professional association's code, as referenced or assimilated by the licensing body. though some state licensing boards incorporate professional association ethics into their rules, many do not. 34 in practice, state licensing boards have been reluctant to discipline member hps based on complaints exposure to extreme heat or cold; threats of harm or death; isolation; sensory deprivation and overstimulation; sleep deprivation; or the threatened use of any of the above techniques to an individual or to members of an individual's family. id. at 2. the 2008 apa resolution against torture specifically prohibited psychologists from "knowingly planning, designing, participating in or assisting in the use of all condemned techniques at any time ... ." id. 34 for example, statutory or regulatory incorporation of the ama ethics guidelines into the state licensing body's rules exists in only a minority of states: alaska, hawaii, iowa, kentucky, maryland, mississippi, nebraska, new hampshire, new mexico, ohio, tennessee, and west virginia. alper, supra note 28, at 22. of those, hawaii, kentucky, and ohio expressly empower the state medical board to discipline physicians for conduct that violates the ama's code of ethics. ayham bahnassi, keeping doctors out of the interrogation room: a new ethical obligation that requires the backing of the law, 19 health matrix 447, 483 (2009). vol. 11:1142 legal but unethical suggesting hps' interrogation-related activities ostensibly violated the professional associations' ethical rules.35 even state licensing bodies do not wield unfettered authority, a reality clearly demonstrated in the analogous area of lethal injection. the ama and various state licensing boards have prohibited physician participation in lethal injection since 1980, but despite physician participation in hundreds of such executions, no physician has been disciplined, and courts have blocked state licensing boards that have attempted to do so.36 35 for example, a psychologist filed a complaint with the new york state education department's office of professional discipline against the new york-licensed bsct psychologist who helped create the bsct counter-resistance strategy memorandum, discussed below, requesting approval for various enhanced interrogation techniques and who was present during at least some of the qahtani interrogation. when healers harm: hold health professionals accountable for torture, center for const. rts., http://whenhealersharm.org/john-leso (last visited dec. 26, 2013). new york's director of investigations rejected the complaint via telephone claiming the office "lacked jurisdiction" over the matter. id. a new york state trial judge subsequently refused to force the new york office of professional discipline to investigate the matter. john eligion, judge won't order inquiry over psychologist's role in guantdnamo, n.y. times (aug. 12, 2011), http://www.nytimes.com/2011/08/12/nyregion/judge-wont-order-inquiryover-psychologists-role-in-guantanamo.html. additionally, at least four complaints have been filed against this psychologist with the ethics committee of the american psychological association. center for const. rts., supra. none has been acted upon. similar complaints against other military psychologists in louisiana, ohio, and texas have also not been acted upon. id. 36 see, e.g., order granting plaintiffs request for declaratory relief & denying defendant's motion to dismiss at 5, n.c. dep't. of corr. v. n.c. med. bd., no. 07-cvs-3574 (n.c. super. ct. sept. 21, 2007), http://www.newsobserver.com/content/media/2007/9/21/ doco92107.pdf (granting the north carolina department of corrections' request for an injunction against the north carolina medical board preventing it from "taking disciplinary action against physicians who have participated in or otherwise have been involved in judicial executions by lethal injection" because state law specifically authorizes lethal injection); zitrin v. ga. composite state bd. of med. examiners, 653 s.e.2d 758, 763 (ga. ct. app. 2007) (upholding trial court's dismissal of physician's claim seeking declaratory relief requiring state medical board to take professional action against doctors participating in lethal injunctions for lack of standing). cf fons v. ohio 2014 143 indiana health law review state legislatures have also considered the participation of hps in interrogation. 3 7 for example, legislation has been introduced in new york prohibiting hps from participating in torture or "improper treatment" of detainees, the latter defined as "cruel, inhuman or degrading, treatment or punishment as defined by applicable international treaties and their corresponding interpreting bodies; or cruel and unusual punishment as defined in the united states constitution or the new york state constitution."3 8 the bill would also prohibit hps from participating "in the interrogation of a prisoner, including being present in the interrogation room, asking or suggesting questions, advising on the use of specific interrogation techniques, monitoring the interrogation, or medically or psychologically evaluating a person for the purpose of identifying potential interrogation methods or strategies."39 notably, these are not criminal prohibitions, but rather would authorize the state office of professional discipline, the licensing board, to take action against offending members of the health professions. in a joint resolution, the california legislature expressed its strong condemnation of the practice of physician participation in enhanced interrogation. the resolution asserts "[t]he united states department of defense has failed to oversee the ethical conduct of california-licensed hps related to torture" and requests the dod and cia remove all california-licensed health professionals from participating in any way in prisoner and detainee interrogations that are state medical board, 614 n.e.2d 748 (ohio 1993) (upholding state licensing board's action taken against a doctor based on a violation of ama ethics code); gladieux v. ohio state med. bd., 728 n.e.2d 459 (ohio ct. app. 1999) (upholding state licensing board's discipline of physician for engaging in sexual relationships with patients that violated state statute). 37 see, e.g., a5891, 2011-2012 gen. assemb., reg. sess. § 2 (n.y. 2011); h.3361, 187 gen. ct., reg. sess. (m.a. 2011); s.j. res. 19, 20072008 reg. sess. (cal. 2008). 38 a5891, 2011-2012 gen. assemb., reg. sess. § 2 (n.y. 2011). s9 id. vol. 11:1144 legal but unethical coercive or "enhanced" or that involve torture or cruel, inhuman, or degrading treatment or punishment, as defined by the geneva conventions, cat, relevant jurisprudence regarding cat, and related human rights documents and treaties. the joint resolution further directed california's health professional licensing agencies to notify hps about their professional obligations under international law, specifically common article iii of the geneva conventions, the convention against torture and other cruel, inhuman, or degrading treatment or punishment (cat), and the amended war crimes act, which prohibit the torture of, and the cruel, inhuman, and degrading treatment or punishment of, detainees in united states custody [and] that those who participate in coercive or "enhanced" interrogation, torture, as defined by cat, or other forms of cruel, inhuman, or degrading treatment or punishment may one day be subject to prosecution.40 though this joint resolution passed the california legislature, without the governor's signature, it is not law. state legislation of this type raises significant constitutional questions outside the scope of this article. for example, while regulation of health care providers is typically considered a state function, as one of many powers reserved to the several states under the tenth amendment of the united states constitution; where national security interests are at issue-including the specific actions of the federal military forces-such state regulation is likely preempted under one of several theories. 41 the new york 40 id. (emphasis added). 41 congress's powers include the power to define and punish offenses against the law of nations, make rules concerning captures on 2014 145 indiana health law review legislation noted above recognizes this issue, stating "[t]he legislature is mindful that ordinarily there are limits on new york state's jurisdiction relating to conduct outside the state or under federal authority. however, it is proper for the state to regulate health care professional licensure in relation to a professional's conduct, even where the conduct occurs outside the state. .. ."42 iii. application of law and ethical standards to health professionals' activities this section identifies and illustrates the various types of interrogation-related activities in which mhps have engaged that have become the subject of allegations of misconduct and applies available and applicable law and ethical standards to those types of activity. where available, real examples of activities alleged to constitute misconduct by hps are provided. 43 as will be demonstrated, while professional ethical standards are implicated by nearly every interrogation-related activity for which hps have been criticized, the lawis silent on most. land and water, raise and support the army, provide and maintain the navy, and make rules for the government and regulation of the land and naval forces. u.s. const. art i, § 8. and of course, the president has authority as commander-in-chief. id. at art. ii, § 2. for discussion of federal preemption of powers traditionally reserved to the states in the context of national security, see, e.g., e.l. gaston, taking the gloves off of homeland security: rethinking the federalism framework for responding to domestic emergencies, 1 harv. l. & pol'y rev. 519 (2007) ("federalism preferences must take a backseat to the country's immediate need for a functional preparedness and response system."); felice batlan, law in the time of cholera: disease, state power, and quarantines past and future, 80 temp. l. rev. 53 (2007); alan dershowitz, preemption: a knife that cuts both ways (2006). one commentator correctly observed the distinction between ethics and law in this area, advocating state legislation proscribing physicians' involvement in interrogation, but ignored completely the possibility such legislation would be unconstitutional or preempted. bahnassi, supra note 34. 42 a5891, 2011-2012 gen. assemb., reg. sess. § 1 (n.y. 2011). 43 the examples provided are not intended as an exhaustive catalog of all such conduct, nor are the examples provided necessarily the most egregious. 146 vol. 11: 1 legal but unethical a. general involvement in interrogation planning and training participation by mhps in general detainee interrogation planning and training activities-as opposed to specific interrogations-occurred early in the global war on terror ("gwot"). mhps were involved in creating the interrogation plans and techniques designed at headquarters, implemented initially at guantanamo, and subsequently employed elsewhere in the gwot. activities included suggesting and opining on specific interrogation methods, including some that would later be called "enhanced interrogation techniques," and providing training to interrogators and other hps. 1. examples: headquarters-level general interrogation plans and methods development that the dawn of the united states military's use of "enhanced interrogation techniques" in the gwot coincided with the dawn of mhps' involvement in interrogation was not "coincidental." apparently without being requested to do so, in april 2002, dr. bruce jessen, a psychologist with experience providing interrogation resistance training (that is, defensive rather than offensive interrogation training) in the united states military's survival, evasion, resistance, and escape ("sere") training programs drafted an "exploitation plan" for interrogating detainees and provided it to his commander at the joint personnel recovery agency ("jpra"). 44 dr. jessen's exploitation plan contained recommendations for jpra involvement in the detainee exploitation process, including jpra deploying a core "captivity/exploitation team" under his lead. 45 that is, dr. jessen recommended that he-a psychologist with no 44 s. comm. on armed services, 110th cong., rep. on inquiry into the treatment of detainees in u.s. custody 14 (comm. print 2008) [hereinafter sasc report]. the "exploitation draft plan," which was circulated on april 16, 2002, stated that its objective was to "[hlold, manage and exploit detainees to elicit critical information." id. 45 id. 2014 147 indiana health law review offensive interrogation experience-direct the united states' interrogation of al qaeda detainees. demonstrating awareness there would be legal limitations, but ignorance of the breadth of legal restrictions, the plan included operational principles for exploitation, the "only restricting factor [for which] should be the torture convention."46 later, when formulating the bush administration's enhanced interrogation policy, the dod general counsel requested jpra provide information regarding the longterm psychological effects of interrogation resistance training employing various harsh interrogation techniques. 47 jpra turned to the air force sere school's senior psychologist, dr. jerald ogrisseg, for assistance. dr. ogrisseg initially demurred, asking whether real world waterboarding would be illegal and noting that "aside from being illegal, it was a completely different arena that we in the survival school didn't know anything about." 48 ultimately, dr. ogrisseg produced a memorandum that concluded "if there are any long-term psychological effects of [united states air force sere training], they are certainly minimal," importantly attributing that conclusion to specific efforts the sere program undertook to minimize the risk of 46 id. at 15. 4 id. at 29 (referring to bybee memo to gonzales, supra note 10, and memorandum from jay s. bybee, assistant att'y gen., to john rizzo, acting gen. counsel for the central intelligence agency 9 (aug. 1, 2002) [hereinafter bybee memo to rizzo], available at http://luxmedia.com.edgesuite.net/aclulolc_08012002jbybee.pdf). ostensibly, this request was to formulate a position regarding the soonto-be created legal position of the administration regarding whether various techniques caused "significant psychological harm of significant duration, e.g., lasting for months or even years," the standard ultimately articulated in the "bybee memo" for determining whether interrogation activities constituted "torture" under 18 u.s.c. §§ 23402340a. bybee memo to gonzales, supra note 10. this memorandum, along with the bradbury memoranda, was withdrawn by the office of legal counsel ("olc") on june 11, 2009. memorandum for the attorney general from david j. barron, acting assistant attorney general, office of legal counsel, for the att'y general, re: withdrawal of office of legal counsel opinion (june 11, 2009) [hereinafter barron memo of june 11, 20091, available at http://www.justice.gov/olc/2009/ memo-barron2009.pdf. 48 sasc report, supra note 44, at 29. 148 vol. 11:1 legal but unethical long-term psychological effects, efforts that would be absent when the united states ultimately employed the sere techniques to interrogate real detainees. 49 without dr. ogrisseg's knowledge, his memorandum later played a part in the formulation of the so-called "bybee torture memos," issued on august 1, 2002, that provided legal justification for various enhanced interrogation techniques. 50 thus, policymaking at the highest level regarding acceptable interrogation activities in the gwot was directly informed by military psychologists. the fact that policymaking regarding how to interrogate detainees was informed by psychological assessment of the results of counter-resistance training provided to voluntary trainees is a blunder difficult to understand.5 1 even more 49 id. at 29-30. the air force minimized risk to sere trainees by, among other things: performing three extensive debriefings during training. dr. ogrisseg said that "affording students these opportunities to discuss their training experiences in open group environments mitigates the risk of turning a 'dramatic' experience into a 'traumatic' experience." he told the committee that there are numerous controls in place at sere school to ensure that the training does not become "traumatic" for its students. id. 50 dr. ogrisseg's memorandum was forwarded to dod general counsel's office approximately one week before the two "bybee torture memos" were issued on august 1, 2002. sasc report, supra note 44, at 30. this memorandum played a part in the formulation of the bybee memos' articulation of harm and authorization for certain interrogation techniques. id. at 31-35. dr. ogrisseg was surprised to learn his memorandum had been forwarded to dod general counsel because his analysis was produced with volunteer students in mind, not detainees. he later testified to the sasc that the conclusions in his memorandum were "not applicable to the offensive use of sere techniques against real world detainees." id. at 30. 51 in fact, dr. ogrisseg later identified seven key differences between the sere training environment and detainee interrogation. id. at 31. indeed, many of the "physical pressure" techniques used during mock interrogation at sere training are for the purpose of increasing resistance to interrogation, rather than decreasing it. id. at 2014 149 indiana health law review egregious from a legal standpoint, the sere training that would be reverse-engineered to become the enhanced interrogation techniques was itself explicitly intended "to replicate harsh conditions that the service member might encounter if they are held by forces that do not abide by the geneva conventions."52 2. examples: guantanamo interrogation plan development by fall 2002, increased high-level pressure was being put on personnel at joint task force 170 ("jtf 170")-the command with responsibility for detention operations at guantanamo-to produce actionable intelligence from detainee interrogation activities.5 3 this pressure resulted in the creation of a guantanamo-specific interrogation plan that would ultimately form the basis for interrogation plans at other military detention facilities. a newly constituted team of hps created for the specific purpose of assisting interrogations-the behavioral science consultation team ("bscts," colloquially pronounced "biscuits")-played a critical role in the drafting of the guantanamo interrogation plan.54 the first such team was created shortly after the june 2002 arrival of three army hps-a psychiatrist, a psychologist, and an enlisted 53 (citing email from ltc morgan banks to maj paul burney (oct. 2, 2002)). 52 office of the inspector general of the department of defense, review of dod-directed investigations of detainee abuse 23 (aug. 25, 2006), available at http://humanrights.ucdavis.edul projects/the-guantanamo-testimonials-project/testimonies/testimoniesof-the-defense-department/dod inspector-general.pdf (emphasis added). 53 such pressure included direct communications from thendeputy secretary of defense paul wolfowitz that "[guantanamo] should use more aggressive interrogation techniques." sasc report, supra note 44, at 41-42. 54 miles, supra note 3, at 53-54. bscts were not new creations for the purpose of interrogation at guantanamo. rather, they had long existed in the united states military for non-interrogation purposes, such as evaluating service members' suitability for a particular duty, treating combat-related stress, and improving unit morale and cohesion. id. at 54. 150 vol. 11:1 legal but unethical psychiatry technician-to guantanamo. 55 these hps whose previous duties had never involved interrogation were thrust without preparation into a non-care role. 56 remarkably, none of the new medical providers had any training to support interrogations, though they ultimately attended a short training provided by jpra "with the expectation they would learn about and bring back interrogation techniques that could be considered for use in interrogations at gtmo."57 by this point, if not earlier, the rubicon was crossed. no longer was interrogation technique development in the hands of psychologists who were career resistance training specialists; active duty hps who had deployed expecting to provide medical and psychological care to united states service members were now part of the interrogation team.5 8 initially, there was no standard operating procedure in place for the bsct at guantanamo. by november 2002, a 55 sasc report, supra note 44, at 38. though bscts initially included psychiatrists, from mid-2003, the positions were usually filled by psychologists. office of the surgeon general of the army, assessment of detainee medical operations for oef, gtmo, and oif 18-2 (apr. 13, 2005), available at http://humanrights.ucdavis.edu/ resources/library/documents-and-reports/detmedopsrpt.pdf [hereinafter army surgeon general assessment]. 56 the circumstances of their arrival illustrate some of the professional confusion detainee interrogation operations causes for medical providers asked to participate in interrogation activities. all three providers were members of the army's 85th medical detachment's combat stress control team and arrived at guantanamo erroneously expecting to care for united states service members dealing with deployment-related stress. sasc report, supra note 44, at 38-39. 57 id. 58 bscts would become important elements of interrogation operations at other locations as well. in his 2003 assessment of intelligence problems at abu ghraib, major general geoffrey miller, who had commanded jtf-170 at gtmo, identified the lack of a bsct supporting intelligence operations as a problem, stating bscts were "essential in developing integrated interrogation strategies and assessing interrogation intelligence production." geoffrey d. miller, assessment of dod counterterrorism interrogation and detention operations in iraq (u), 5 (sep. 9, 2003), available at http://www.dod.mil/pubs/foi/operation-and-plans/detainee/taguba/ann ex_020_mgmillerreport.pdf. 1512014 indiana health law review written procedure was created that described bsct tasks as including the following: consulting on interrogation approach techniques, conducting detainee file reviews to construct personality profiles and provide recommendations for interrogation strategies; observing interrogations and providing feedback to interrogators on detainee behavior, flow of the interrogation process, translator and cultural issues and possible strategies for further interrogation; and providing consultation/training on specific behavioral science interviewing and observational techniques that promote productive interrogation.5 9 the november standard operating procedure stated the bsct "does not conduct medical evaluation or treatment of detainees and does not participate in determining medical treatment protocols for detainees." 60 this attempt to distinguish hps engaged in healthcare from those who were not has been a consistent approach of the united states department of defense, ultimately culminating in a regulation to that effect, dodi 2310.08e. in response to increased political pressure to obtain actionable intelligence, in fall 2002, the bsct was directed to draft an interrogation policy that could be formally submitted up the chain of command for review.61 some of the interrogation approaches the bsct identified in its memorandum came from their brief jpra training, while other approaches were "simply made up by the bsct."62 this level of participation by hps in the planning of interrogation techniques is unusual. military personnel who just prior to their deployment to guantanamo had been 59 sasc report, supra note 44, at 39 (citing jtf gtmo-bsct memorandum, bsct standard operating procedures (nov. 11, 2002)). 6 0 id. 61 sasc report, supra note 44, at 50. 62 id. 152 vol. 11: 1 legal but unethical providing medical treatment to united states service members, and who had no experience with interrogation, were now creating the proposed techniques that would become the basis for military use of enhanced interrogation techniques. in the course of one evening, the bsct psychiatrist and psychologist produced the bsct counter-resistance strategy memorandum, proposing three categories of interrogation techniques to "develop rapport, promote cooperation, and counter resistance." 63 "category i" techniques included incentives and "mildly adverse approaches" such as telling a detainee that he was going to be at guantanamo forever unless he cooperated. 64 "category ii" techniques, which included stress positions, the use of isolation for up to 30 days, and hooding, were suggested for "high priority" detainees, defined in the memo as "any detainee suspected of having significant information relative to the security of the united states."65 "category iii" techniques were proposed "only for detainees that have evidenced advanced resistance and are suspected of having significant information pertinent to national security." 66 "category iii" techniques included sleep deprivation and: the daily use of 20 hour interrogations, the use of strict isolation without the right of visitation by treating medical professionals or the international committee of the red cross (icrc); the use of food restriction for 24 hours once a week; the use of scenarios designed to convince the detainee he might experience a painful or fatal outcome; non-injurious physical consequences; removal of clothing; 63 id. at 50-52 (citing major paul burney and [redacted], memorandum for record, counter-resistance strategies (oct. 2, 2002) [hereinafter bsct counter-resistance strategies memorandum]). 64 id. at 51. 65 id. at 52 (quoting bsct counter-resistance strategies memorandum, supra note 63, at 2). 66 id. at 52. 2014 153 indiana health law review and exposure to cold weather or water until such time as the detainee began to shiver.67 the bsct's discomfort with some of the techniques they included in their own memorandum highlights the tension hps face when assigned to participate in interrogation activities. the counter-resistance strategy memorandum contained language in which the bsct disclaimed some of the very techniques offered: experts in the field of interrogation indicate the most effective interrogation strategy is a rapport-building approach. interrogation techniques that rely on physical or adverse consequences are likely to garner inaccurate information and create an increased level of resistance. . . . the interrogation tools outlined could affect the short term and/or long term physical and/or mental health of the detainee. physical and/or emotional harm from the above techniques may emerge months or even years after their use. it is impossible to determine if a particular strategy will cause irreversible harm if employed. 68 the bsct counter-resistance strategies memorandum was immediately discussed in a meeting at guantanamo 67 id. at 52 (quoting bsct counter-resistance strategies memorandum, supra note 63, at 4-5). in addition to specific interrogation techniques, the memorandum made recommendations for the treatment of detainees in the cell blocks, specifically proposing that "resistant detainees might be limited to four hours of sleep a day; that they be deprived of comfort items such as sheets, blankets, mattresses, washcloths; and that interrogators control access to all detainees' korans." id. the memorandum also described using white noise as a form of psychological pressure and advocated that "all aspects of the [detention] environment should enhance capture shock, dislocate expectations, foster dependence, and support exploitation to the fullest extent possible." id. 68 id. at 52 (quoting bsct counter-resistance strategies memorandum, supra note 63). 154 vol. 11: 1 legal but unethical that included command-level personnel and several lawyers, including both the staff judge advocate (senior military attorney) for jtf-170 and a cia attorney. 69 according to the meeting minutes, the bsct representative offered that psychological stressors such as "sleep deprivation, withholding food, isolation, and loss of time" were "extremely effective" and identified "camp-wide, environmental strategies designed to disrupt cohesion and communication among detainees" as potentially helpful to improve the effectiveness of interrogations and explained that the detention "environment should foster dependence and compliance." 70 ultimately, the bsct-drafted, three-category approach to increasing interrogation methods, which itself was based on what bsct members had learned from their interaction with jpra regarding sere counter-resistance training, became the basis for the guantanamo interrogators' request for approval of more aggressive interrogation techniques that was forwarded to the pentagon.7 ' 69 email from thomas blane to sam mccahon, fw: counter resistance strategy meeting minutes (oct. 24, 2002, 7:57 pm), available at http://www.torturingdemocracy.org/documents/20021002. pdf) [hereinafter counter-resistance strategy meeting minutes]. during the meeting, the bsct briefer reiterated that rapport building and the "friendly approach" were proven to "yield positive results," while "fear based approaches" were .'unreliable' and "ineffective in almost all cases." id. unfortunately, "despite bsct comments on the effectiveness of rapport building, the meeting minutes reflect little discussion of that approach." sasc report, supra note 44, at 54. 70 fw: counter-resistance strategy meeting minutes, supra note 69. after the meeting, the bsct psychiatrist remained actively involved in preparation of more aggressive interrogation tactics, including attempts to find training opportunities for interrogators. sasc report, supra note 44, at 57. the psychiatrist contacted another headquarters, reporting that "were more aversive techniques approved for use in the future by appropriate people, the operation would like to have a few task force personnel specifically trained in various techniques." id. (quoting email from major paul burney to lieutenant colonel morgan banks (oct. 4, 2002) (internal quotes omitted)). 71 interrogators requested permission from jtf-170 commander major general dunlavey to use counter-resistance interrogation techniques. sasc report, supra note 44, at 61. the request memorandum "was largely drawn from the october 2, 2002[,] 2014 155 indiana health law review in fact, the guantanamo-specific interrogation techniques initially drafted by the bsct psychiatrist and psychologist were ultimately borrowed and employed by interrogation operations elsewhere, including in afghanistan and iraq. 72 the widespread adoption of the interrogation procedures is extraordinary, not only because it was based on a memorandum initially prepared by a psychiatrist and psychologist, but also because of the differences in legal status of detainees in guantanamo, afghanistan, and iraq. thus, interrogation approaches initially authorized for a "war on terror" taking place largely in afghanistan and at guantanamo -a war to which the president had erroneously determined the protections of the geneva conventions did not apply-would memorandum that the guantanamo [bsct1 had written upon their return from the jpra training at fort bragg." id. in fact, the memorandum contained the same three-category approach and virtually the same techniques originally described in the bsct's counterresistance strategy memorandum. id. notably, two of the category iii techniques in this request memorandum-the use of phobias and the use of the "wet towel and dripping water" (i.e., "waterboarding") to induce the misperception of suffocation-were not derived from the bsct counter-resistance strategy memorandum. 72 contemporaneous to drafting the bsct counter-resistance strategy memorandum, the guantanamo bsct briefed visitors from the special mission unit ("smu") task force ("tf') assigned to interrogations in afghanistan (smu tf-afghanistan). sasc report, supra note 44, at 149. ultimately, the smu tf-afghanistan interrogation standard operating procedure contained interrogation techniques from the guantanamo bsct memorandum and was "influenced" by it. id. at 153-54. in 2006 the department of defense inspector general concluded that the smu sop "was influenced by the counter-resistance memorandum that the secretary of defense approved on december 2, 2002," which was itself based on the bsct counter-resistance strategy memorandum. likewise, the smu tf in iraq's (smu tf-iraq) interrogation policy, in place before the beginning of oif, was identical to the february 2002 policy in use by the smu tfafghanistan and "reflected the influence of techniques authorized for use at gtmo." id. at 158. ultimately, techniques identified in proposed interrogation policy at abu ghraib can be traced back to techniques authorized for use at guantanamo by secretary rumsfeld in december 2002, which were based on the bsct counter-resistance strategy memorandum authored by a psychiatrist and psychologist. id. at 170. 156 vol. 11:1 legal but unethical ultimately be authorized for all united states interrogations in iraq, where the geneva conventions clearly did apply. it is important to note that ultimately another health professional helped bring about the end of the approved military use of category ii and category iii interrogation techniques at guantanamo. navy criminal investigative service chief psychologist michael gelles blew the whistle on the techniques by meeting with navy general counsel alberto mora, explaining how the techniques were being used at guantanamo. 73 ultimately, after significant efforts by mr. mora, on january 15, 2003, secretary of defense rumsfeld withdrew approval for use of category ii and category iii techniques. 74 3. examples: general interrogation training military medical provider involvement in interrogation training also began early in the gwot. in fact, military psychologists were among the first to prompt discussion of how to overcome detainee resistance to interrogation techniques and prepared a paper on al qaeda counterresistance techniques for use by united states interrogators, a report that resulted in interrogators receiving training to overcome such techniques.7 5 in march 2002, dr. bruce jessen, the senior sere psychologist at jpra who had suggested he direct interrogation of detainees, was part of a two-person team that trained 73 sasc report, supra note 44, at 106. 74 id. at 107-08. after meeting with dr. gelles, in january 2003, and after consulting with other dod legal personnel, mr. mora expressed his concerns to dod general counsel haynes. id. at 106. in a dramatic encounter, on january 15, 2003, mr. mora provided a copy of a draft memorandum from him to mr. haynes that opined that "the majority of the proposed category ii and all of the proposed category iii techniques were violative of domestic and international legal norms in that they constituted, at a minimum, cruel and unusual treatment and, at worst, torture." id. at 108. mr. mora told mr. haynes he would sign the draft memorandum unless secretary rumsfeld withdrew approval for category ii and category iii techniques that day. id. 75 id. at 6-7. 2014 157 indiana health law review interrogators headed to guantanamo and afghanistan.7 6 the training, called "al qaeda resistance contingency training," described methods used by al qaeda to resist interrogation and exploitation and countermeasures to defeat those methods.7 7 this training included "isolation and degradation," "sensory deprivation," "physiological pressures," and "psychological pressures."78 additionally, one military intelligence analyst at guantanamo reported that "the notion of using sexual gambits to unnerve detainees was promoted by 'the bscts, who were these psychiatrists and psychologists from fort bragg.'"79 by september 2002, psychologists were training not only interrogators, but also other military psychologists assigned to guantanamo.s0 76 id. at 8-9. jpra psychologists were involved in training not only military interrogators, but "other government agency" interrogators at various points in 2002, which training "suggested 'exploitation strategies."' id. at 19-20 (quoting memo from colonel john prior ii to jpra/cc (colonel randy moulton), request from [redacted] for interrogation training support (jun 20, 2002)). though redacted, from the context of the references and redactions, it appears the "other government agency" was the cia. such activities mean mhps were at least indirectly involved in "other government agency" interrogation of al qaeda detainees that otherwise had no tie to military activities. in fact, the senior sere psychologist was detailed to the "other government agency" in july 2002. id. at 23-24. 77 id. at 8-9. 78 id. at 9. dr. jessen's after-action report indicated the training provided suggestions on "how to exploit al qaeda detainees for intelligence within the confines of the geneva conventions." id. at 10. however, dr. jessen later testified before the sasc that he would "not have known at the time if isolation, degradation, sensory deprivation, or other topics referenced in the slides would have been within the confines of the geneva conventions." id. at 11. 79 jane mayer, the experiment, the new yorker, july 11 & 18, 2005, at 60, 65. 80 in september 2002, the then senior sere psychologist, dr. gary percival, along with non-medical interrogation instructors, trained army psychologists assigned to gtmo in "exploitation from a sere perspective." sasc report, supra note 44, at 44. it should be noted that throughout the course of the gwot, various personnel within jpra and at command echelons above jpra objected to jpra's involvement in training interrogators. one particularly candid assessment came from the staff judge advocate ("sja") (senior lawyer) vol. 11:1158 legal but unethical 4. application of law and ethical standards to general in terroga tion in volvem en t a. law simply stated, the act of hps planning interrogations or providing training in interrogation methods does not itself constitute a violation of any international or domestic law. in fact, no international or domestic law prohibits anyone's involvement in general interrogation planning or interrogation training, let alone specifically forbids hps' involvement. given the absence of law proscribing general planning and training, such activities could only become a at joint forces command ("jfcom"), jpra's higher headquarters. the sja stated: [ilt is not advisable to have jpra assist in "improving exploitation" (i.e., suggesting more effective interrogation techniques). jpra's core expertise is in training dod personnel to resist/cope with techniques many of them illegal that may be employed by our enemies if dod personnel are captured. it just doesn't make sense to me to have experts in what the "bad guys" do to us advising our u.s. interrogators.... id. at 227 (quoting email from captain dan donovan to admiral edmund giambastiani, jfcom commander (may 13, 2004)). additionally, a sere psychologist poignantly observed: [wie need to really stress the difference between what instructors do at sere school (done to increase resistance capability in students) versus what is taught at interrogator[] school (done to gather information). what is done by sere instructors is by definition ineffective interrogator conduct, and interrogator school, not sere school is the appropriate focus and model for investigating interrogators. simply stated, sere school does not train you on how to interrogate, and things you "learn" there by osmosis about interrogation are probably wrong if copied by interrogators. id. at 229 (quoting email from lieutenant colonel richard posey to major paul voss, (july 12, 2004)). 2014 159 indiana health law review violation of law if the subsequent interrogations themselves violate the law, thereby implicating those involved in planning and training through some theory of secondary liability. whether mhps' activities give rise to accomplice liability requires analysis complicated by the variety of jurisdictions that could apply it.81 in any event, whether 81 significant differences among jurisdictions are especially noticeable regarding the mental element (mens rea). united states federal courts generally follow the model penal code and require that an accomplice act with the purpose of promoting or facilitating the offense. that is, whether the purported accomplice "associated himself with the venture" or sought "by his action to make it succeed." see nye & nissen v. united states, 336 u.s. 613, 618-19 (1949). it is important to acknowledge that despite supreme court precedent, federal case law on this issue is not as simple as this general summary suggests. see baruch weiss, what were they thinking?: the mental states of the aider and abettor and causer under federal law, 70 fordham l. rev. 1341, 1350-52 (2002). various states, however, have differing mens rea requirements. see, e.g., john decker, the mental state requirement for accomplice liability in american criminal law, 60 s.c. l. rev. 237 (2010) (comparing states' approaches). further, if the matter were being determined by a foreign court under universal jurisdiction (for example, in the prosecution of a "grave breach" of the geneva conventions), it is entirely unclear which standard would be used. international tribunals have historically applied the knowledge (rather than purpose) standard, which only requires the accomplice be reasonably aware their actions would facilitate the ultimate offense, but other international law suggests a purpose standard might apply. see, e.g., trial of bruno tesch and two others, 1 war crimes comm'n, u.n. law reports of trials of war criminals 93 (1947) (british military court hamburg, germany) (finding defendants guilty of knowingly providing chemicals used in nazi gas chambers); prosecutor v. aleksovski, case no. it-95-14/1-a, judgment, tt 61, 79-80 (int'l trib. for the former yugoslavia mar. 24, 2000); prosecutor v. furundzija, case no. it-95-17/1-t, judgment, it 245-46 (int'l trib. for the former yugoslavia dec. 10, 1998). however, while one rome statute provision on complicity requires purpose, a second provision governing complicity in collective criminality requires only knowledge of the underlying offense. compare rome statute of international criminal court art. 25(3)(c), july 17, 1998, 2187 u.n.t.s. 90 ("for the purpose of facilitating the commission") with art. 25(3)(d)(ii) (contributions made "in the knowledge of the intention of the group to commit the crime"). the second provision is arguably most applicable to hps who provided assistance not to a single individual but to multiple individuals acting with a "common purpose" to torture or unlawfully degrade detainees. but see presbyterian church of sudan v. talisman energy, inc., 582 160 vol. 11-1 legal but unethical mhps' participation in general plans and methods development violated law rests not on any law specific to hps, but rather on accomplice liability applicable to anyone. b. ethics in the area of general participation in interrogation planning and training, international and domestic ethical standards are somewhat less restrictive than in other areas discussed in the following sections. no international or domestic ethical standard outright prohibits participation in general interrogation planning and training and some explicitly allow such participation. according to some ethicists, medical personnel "should not be party to interrogation practices contrary to human rights law or the laws of war, and their role in legitimate interrogation should not extend beyond limit setting, as guardians of detainees' health."82 but where does the line between "limit setting" and participation lie? the u.n. principles of medical ethics prohibit physicians from applying their knowledge in order to assist in the interrogation of detainees "in a manner that may adversely affect the physical or mental health or condition of such . . . detainees and which is not in accordance with the relevant international instruments." 8 3 likewise, the wvma regulations in times of armed conflict state it is unethical for physicians to "employ scientific knowledge to imperil health." thus, these international ethical standards arguably constrain physicians' participation in general interrogation planning or training no more than law, assuming interrogation techniques that adversely affect the physical or mental health of the detainee are already proscribed by law. 84 under these standards, where f.3d 244, 259 (2d cir. 2009) (addressing a recent alien tort statute case and concluding that international criminal law follows the purpose standard). 82 m.g. bloche & j.h. marks, doctors go to war, supra note 10, at 5. 83 u.n. principles of medical ethics, supra note 27, para. 4. 84 of course, this is the subject of intense debate. 2014 161 indiana health law review techniques are legal but adversely affect health, hps could not participate. on the other hand, as revised in 2006, the declaration of tokyo explicitly forbids physicians from using their knowledge to "facilitate any interrogation, legal or illegal."8 5 whether this applies to general interrogation planning is unclear, but providing general strategy and training arguably constitutes "facilitation," at least indirectly. thus, as of the later-revised declaration of tokyo, the types of planning and training activities in which mhps engaged early in the gwot were "unethical." interestingly, the domestic ethical standards of both the ama and the american psychiatric association leave open the possibility of giving general advice on interrogation strategy and training to military and civilian personnel in either law enforcement or intelligence branches, so long as the interrogations are "humane and respectful of individuals' rights" and do not "threaten or cause physical injury or mental suffering" (in the case of physicians of the ama) 86 or are related to providing interrogators with training on the "possible medical and psychological effects of particular techniques and conditions of interrogation" (in the case of psychiatrists of the american psychiatric association).87 this allowance is premised on the idea that professionals' involvement will lead to interrogation techniques that are safer for those being interrogated. in contrast to the ethical standards for medical doctors, the apa only constrains members from providing support, advice or training "in torture, cruel, inhuman, and degrading treatment," or in settings where persons are held outside of or in violation of international law or the united states constitution.88 85 revised declaration of tokyo, supra note 27 (emphasis added). 86 ama opinion 2.068, supra note 29, para. 4. 87 2006 position statement, supra note 30, para. 3. 88 2006 apa resolution against torture, supra note 32; 2008 apa resolution against torture, supra note 33; apa members approve petition resolution on detainee settings, am. psychol. ass'n (sept. 17, 2008), http://www.apa.org/news/press/releases/2008/09/detaineepetition.aspx [hereinafter apa resolution on detainee settings]. even this proscription suggests as many questions as it answers. when a 162 vol. 11:1 legal but unethical thus, except for the declaration of tokyo, most international and domestic ethical standards permit hps to participate in general interrogation plans and methods development and training, so long as it does not adversely affect health or get specific to individual detainees (for doctors) and so long as the interrogation does not constitute "torture, cruel, inhuman, and degrading treatment" (for psychologists). that is, as it relates to general interrogation involvement, ethical standards appear to be not much more restrictive than the law. b. direct involvement in specific interrogation mhps were directly involved in specific interrogations, including planning the interrogations, consulting during interrogations, conducting preand post-interrogation medical and mental health assessments, and, according to some commentators, conducting medical experiments on detainees. in fact, this direct involvement was institutionalized by policy fairly early in the gwot when then-secretary of defense donald rumsfeld issued a memorandum detailing twenty-four authorized techniques for interrogating "unlawful combatants" at guantanamo, and specifically required such techniques be used only when, inter alia, "the detainee is medically . . . evaluated as suitable" and "a specific interrogation plan (including reasonable safeguards . . . and the presence or availability of qualified medical personnel) has been developed."89 techniques authorized in psychologist provides general advice about various interrogation techniques, does the mere discussion of a technique constitute support? what if the health professional discusses a variety of interrogation techniques, some of which are torture and others are not, and the interrogators later determine to use the torturous techniques? is a simple disclaimer by the psychologist regarding certain techniques sufficient to absolve him or her of guilt under this ethical standard or from accomplice liability under the law? 89 rumsfeld approval memorandum of april 2003, supra note 10. additionally, secretary rumsfeld specifically referenced required "medical and psychological review" when isolation was to be used as an interrogation technique. id. 2014 163 indiana health law review this memorandum included benign interrogation methods such as "asking straightforward questions," but also included, and thus required medical evaluation for, sleep deprivation, isolation, and environmental manipulation. 90 it is when we turn from general interrogation planning and training to specific interrogation advice that the chasm between law and professional ethics widens. as with general interrogation involvement, there is no international or domestic law that per se prohibits hps from being directly involved in specific interrogations. despite the absence of law, there are a significant number of professional ethics pronouncements on hps' involvement in interrogations. 1. examples: specific interrogation planning interrogation ofmohammed al-qabtani little information regarding specific interrogations or specific interrogation planning is publicly available. despite having fairly detailed information regarding the qahtani interrogation, it is unclear to what extent the guantanamo bsct or other military providers participated in creating the specific interrogation plan for mohammed qahtani, though it is clear the generalized interrogation methods at guantanamo created by the bsct (discussed above) formed the basis of the specific plan proposed for qahtani. 91 the involvement of hps has been explicitly 90 id. moreover, the bush administration incentivized interrogators to include hps by offering interrogators a defense to prosecution for torture if they "could show that [they] acted in good faith by taking steps such as surveying professional literature, consulting with experts, or reviewing evidence gained from past experience." bybee memo to gonzales, supra note 10, at 8. 91 though it is unclear to what extent the guantanamo bsct team participated in devising the interrogation plan for qahtani and the subsequent request for approval to use aggressive interrogation techniques, at least one military psychologist reviewed the plan and objected. on november 22, 2002, naval criminal investigative service ("ncis") chief psychologist michael gelles formally reviewed the draft plan and stated "[s]trategies articulated in the later phases reflect techniques used to train us forces in resisting interrogation by foreign enemies. . . . [these techniques] would prove not only to be ineffective 164 vol. 11:1 legal but unethical acknowledged by a senior military officer. 92 ultimately, between november 23, 2002 and january 16, 2003, qahtani was subjected to waterboarding, stripping, forced grooming, invasion of space by a female interrogator, being treated like an animal, placed in close proximity to a military working dog, and being forced to pray to an idol shrine, but also border on techniques and strategies deemed unacceptable by law enforcement professionals. . . ." sasc report, supra note 44, at 8081 (quoting memorandum from michael g. gelles to mark fallon, review of jtf-gtmo interrogation plan detainee 063 (nov. 22, 2002) [hereinafter gelles review of jtf-gtmo interrogation plan detainee 063]. he further suggested that if the plan were implemented he would testify as an expert against the proponents of the interrogation. id.at 81. 92 the commander of united states southern command ("southcom"), general james t. hill, later acknowledged the input of medical providers when describing the origin of the aggressive interrogation techniques used in the qahtani interrogation from late 2002 to early 2003: the staff at guantanamo working with behavioral scientists, having gone up to our sere school and developed a list of techniques which our lawyers decided and looked at, said were ok. i sent that list of techniques up to the secretary [of defense] and said, in order for us to get at some of these very high-profile, high-value targets who are resistant to techniques, i may need greater flexibility. . . . and we began to use a few of those techniques, a few of those techniques on this individual. . . general james t. hill, commander, u.s. southern command, media availability with commander, u.s. southern command general james t. hill (june 3, 2004) (transcript available at http://www.defense.gov/transcripts/transcript.aspx?transcriptid=3153). southcom is the dod's combatant command with responsibility over guantanamo. southcom component commands & units, u.s s. command, http://www.southcom.millaboutus/pages/our-team.aspx (last visited dec. 23, 2013). in fact, as demonstrated above, general hill's characterization that guantanamo staff "worked with" behavioral scientists understated the behavioral scientists' input-they had actually drafted the initial memo that became the basis for the request for more aggressive interrogation practices that was ultimately forwarded to the secretary of defense for approval. hill, supra. 2014 165 indiana health law review techniques bearing a striking resemblance to methods employed at sere schools. 93 a. law no international or domestic law prohibits hps from being involved in specific interrogation planning. however, hps should note that there is a risk that such activities could incur accomplice liability if the planned interrogation techniques used are illegal, and that risk is greater than in general interrogation planning. when mhps recommend specific interrogation techniques for use with specific detainees, the actus reus and mens rea elements of accomplice liability are even more clearly established than when involved in general interrogation planning. that is, providing advice constitutes "aid" in the ultimate use of the illegal interrogation technique. 94 the health professional providing the advice has both the knowledge of the primary act and the purpose to assist the interrogator in performing it. the only question becomes whether the primary actus reus is met; that is, whether the recommended interrogation technique itself constitutes a violation of law. b. ethics the icrc has charged hps at guantanamo were engaged in "a flagrant violation of medical ethics" by "participating in planning for interrogations." 95 as with general interrogation planning, though most international ethical standards prohibit physicians from applying their knowledge in order to assist in the interrogation of 93 sasc report, supra note 44, at 88-89 (citing a memo of unknown authorship: methods employed x-ray interrogation isn 63 (jan. 17, 2003)). 94 the analysis of the accomplice's actus reus becomes more complicated when the health professional participates in the planning but neither recommends nor discourages use of a particular illegal technique. 9s neil a. lewis, red cross mnds detainee abuse in guantdnamo, n.y. times (nov. 29, 2004), http://www.nytimes.com/2004/11/30/politics/ 30gitmo.html?_r=1. 166 vol. 11:1 legal but unethical detainees in a manner deleterious to the detainee's physical or mental health, the declaration of tokyo, as revised in 2006, explicitly forbids physicians' use of their knowledge to facilitate any interrogation. 96 and under the 2006 standards of both the ama and american psychiatric association, physicians must not give advice on specific interrogation techniques for specific detainees, regardless of the nature or legality of the techniques. 97 guidance for psychologists is less restrictive, allowing participation so long as interrogation methods do not constitute torture or cruel, inhuman, or degrading treatment. 98 thus, in the example discussed above involving the specific planning of the qahtani interrogation, under current standards (not in force at the time the qahtani interrogation was planned), physicians would be ethically required to not participate at all, while psychologists would be permitted to participate, so long as the methods used did not constitute torture or cruel, inhuman, or degrading treatment.9 9 2. examples: intra -interrogation consultation not surprisingly, specific interrogation planning extended into intra-interrogation consultation (i.e., consultation during interrogation sessions). in fact, bsct operating procedure explicitly called for such 96 u.n. principles of medical ethics, supra note 27; wivia regulations in times of armed conflict, supra note 27; revised declaration of tokyo, supra note 27. 97 ama opinion 2.068, supra note 29, para. 2; 2006 position statement, supra note 30, at para. 3. 98 2006 apa resolution against torture, supra note 32; 2008 apa resolution against torture, supra note 33; apa resolution on detainee settings, supra note 88. of course, this raises the question of whether a psychologist has committed a breach when providing general interrogation advice for use of permitted techniques that is subsequently used by an interrogator in addition to impermissible techniques. 99 of course, several of the techniques planned for use during the qahtani interrogation did constitute torture or cruel, inhuman, or degrading treatment, including waterboarding and forced nudity. 2014 167 indiana health law review involvement. 00 intra-interrogation consultation occurred in two ways: with the providers being physically present at the interrogation and when the providers were physically removed from the interrogation activities, but available for consultation throughout the process. because most interrogation logs have not been declassified, obtaining details of health professional attendance at interrogation sessions is difficult. though secretary rumsfeld's interrogation directive required "presence or availability of qualified medical personnel," it is unclear how frequently medical personnel were "present" rather than merely "available." nevertheless, a few examples exist. presence of hps during the qahtani interrogation is demonstrated by the interrogation log that shows medical personnel intravenously administered three bags of saline during one session.'10 further, statements made by hps involved in the qahtani interrogation are sufficiently specific to suggest their physical proximity to the interrogation activities. 02 evidence of other instances when hps where present for interrogations exists, though details are sparse. for 100 sasc report, supra note 44, at 31. 101 miles, supra note 3, at 61. notably, administration of this quantity of fluid caused qahtani to urinate in his pants. id. see also phillippe sands, torture team: rumsfeld's memo and the betrayal of american values 170-72 (2008) (asserting qahtani's interrogation was conducted with a battery of medical-health personnel in attendance and that these personnel "treaded] [qahtanil for the effects" of the brutal interrogation techniques for the purpose of furthering additional harsh interrogation). 102 for example, a guantanamo bsct psychiatrist who participated in the interrogation stated qahtani was "made [to] believe he was sent to a hostile country which advocated torture" and was also "led to believe he himself might be killed if he did not cooperate with questioning." sasc report, supra note 44, at 88 (quoting written statement of [redacted] (august 21, 2007)). further, he testified a dog was brought into the qahtani interrogation during late november or early december an estimated "half dozen times" and the "dog was never allowed to bite the detainee but would be ordered to bark loudly close to the detainee, to sort of sniff or muzzle the detainee, to put paws up on the detainee," information he was unlikely to have absent actual presence at the interrogation. id. at 90-91. 168 vol. 11:1 legal but unethical example, the "command psychologist" at combined joint special operation task force-arabian peninsula stated "i sit in on random interrogations."10 3 additionally, though the details of the interrogation, and thus the extent of the provider's activities, remain classified, it is clear from the sasc report that retired united states air force sere psychologist dr. james mitchell was physically present during the cia's interrogation of abu zubaydah.104 perhaps the best evidence of the systematic way in which bsct members participated in interrogations at abu ghraib came directly from colonel larry james, the army psychologist sent there to help rehabilitate the facility in the wake of the stunning documented abuses. "the orders from the general, myself, and the intel center director were crystal clear: if the [bsct was not present, there would be no interrogations."10 5 unfortunately, even sparser than evidence that hps were physically present during interrogation is evidence of what they did, making it impossible to judge whether such activity was illegal. even when not present during interrogation, hpsusually members of a bsct-have been routinely consulted regarding interrogations, with interrogators seeking advice regarding how to proceed. for example, during the extended interrogation of mohamadou walid slahi, interrogators became concerned about slahi's report that he was hearing voices. 106 one interrogator emailed a guantanamo bsct psychologist, asking, "[i]s this something that happens to people who have little external stimulus such as daylight, human interaction etc???? 103 sworn statement of [name redacted] (jul. 12, 2004); u.s. army criminal investigation command, dep't of the army, cid report of investigation final 0189-04-cid259-8023315c213/5y2e/5x1/5m3a, 14 (jul. 20, 2004), available at http://www.aclu.org/files/projects/foiasearch/pdf/doddoacid000545.pd f. 104 sasc report, supra note 44, at 17. 105 larry c. james, fixing hell: an army psychologist confronts abu ghraib 131 (2008). 106 sasc report, supra note 44, at 140. 2014 169 indiana health law review seems a little creepy." 0 7 the psychologist responded that "sensory deprivation can cause hallucinations, usually visual rather than auditory, but you never know. . . . in the dark you create things out of what little you have. . . ."tos whether the psychologist took steps to discourage further sensory deprivation in this instance is unknown.109 in another case, an interrogator reported that a bsct doctor, having read the medical file of a detainee, suggested the inmate's longing for his mother could be exploited to persuade him to cooperate. 110 though details remain classified, vice admiral church's investigation and report confirmed hps "observe[d] interrogations, assess[ed] detainee behavior and motivations, review[ed] interrogation techniques, and offer[ed] advice to interrogators." 111 finally, a bsct psychologist apparently insisted interrogators deprive qahtani of sleep during the extended course of his interrogation. 112 one recent approach to attacking mhps' involvement in detention-based interrogation operations has been to label their activities as "medical experiments." several commentators have vigorously urged the united states mhps engaged in human experimentation on detainees at guantanamo and other locations.113 however, it is unclear 107 id. at 140-41 (quoting email from jtf-gtmo interrogator to ltc diane zierhoffer (oct. 17, 2003)). 108 id. at 141 (quoting email from jtf-gtmo interrogator to ltc diane zierhoffer (oct. 17, 2003)). 109 unfortunately, the full text of the emails between the interrogator and the bsct psychologist cited by the sasc report, supra note 44, is not publicly available. 110 neil lewis, interrogators cite doctors' aid at guantanamo prison camp, n.y. times, june 24, 2005, http://www.nytimes.com/2005/ 06/24/politics/24gitmo.html?ex=1277265600&en=bl960558c2ad9fa4&ei =5088&partner=rssnyt&emc=rss [hereinafter lewis, interrogators cite doctors'aia. nm a.t. church, iii, office of the sec'y of def., review of department of defense detention operations and detainee interrogation techniques (u), executive summary (2005) [hereinafter church review], available at http://www.aclu.org/ images/torture/asset upload file625_26068.pdf. 112 see mayer, supra note 79, at 68. 113 see, e.g., brennan, torture of detainees, supra note 3, at 103340 (2011); miles, supra note 3, at 50-59; and physicians for human 170 vol. 11:1 legal but unethical what such commentators mean by "experimentation" and thus the factual support for this allegation is difficult to confirm or disprove.114 professor david brennan vigorously charges hps were involved in human subject experimentation, but only vaguely refers to which conduct constituted experimentation, stating "[tihe activity by medical health personnel described in the preceding passages was prohibited conduct, as defined by domestic and international law." unfortunately, the "preceding passages" constitute a meandering explication of legal and ethical standards and various alleged abuses, most of which do not explicitly deal with hps or with medical experiments, leaving which practices constituted "experiments" unclear.115 in the medical legal context, "experiment" has a specific meaning that is inapplicable to the minimal facts commentators have asserted to support their claims that medical experimentation occurred at united states detention facilities. though he alleges united states hps "fulfilled the same role as the nazi doctors," professor brennan ignores the fact that the nazi doctors completely designed and controlled the entire experiment process and the infliction of harm on subjects was for the purpose of learning the human body's tolerance of or reaction to rights, experiments in torture: evidence of human subject research and experimentation in the "enhanced" interrogation program (jun. 2010) [hereinafter phr, experiments in torture], available athttps://s3.amazonaws.com/phrreports/experiments-in_ torture.pdf. 114 some of guantanamo's own military nomenclature may have contributed to the idea that interrogation involved experiments-jtf170 was called the "battle lab" by consecutive general officers commanding jtf-170. sasc report, supra note 44, at 43. however, even those who objected to this term understood it to refer to the idea that "interrogations and other procedures were to some degree experimental, and their lessons would benefit dod in other places." id. this was not intended to connote that medical experiments were occurring at guantanamo. 115 brennan, torture of detainees, supra note 3, at 1033. indeed, professor brennan provides virtually no details regarding what he contends constituted "medical experiments." id. 2014 171 indiana health law review harm. 116 likewise, the physicans for human rights' ("phr") paper purporting to show the united states engaged in experimentation on interrogated detainees misses the crucial distinction between what the united states is alleged to have done-collecting data about various interrogation methods-and real human subject experimentation: purpose.1 17 in arguing for more international law governing them, renowned international law scholar m. cheriff bassiouni offered one broad definition of medical experiments: "anything done to an individual to learn how it will affect him. its main objective is the acquisition of new scientific 116 specific medical experiments for which nazi medical personnel were convicted, included: 1) high-altitude experiments, to investigate the effect of high-altitude flying; 2) freezing experiments, conducted primarily for the german air force to investigate treatments for persons who had been severely chilled, using prisoners at the dachau camp; 3) malaria experiments to test immunization for and treatment of malaria; 4) mustard gas experiments to investigate treatment of injuries caused by mustard gas; 5) sulfanilamide experiments to test the effectiveness of sulfanilamide and other drugs as treatments for infected wounds; 6) bone, muscle, and nerve regeneration, and bone transplant experiments; 7) seawater experiments to test methods of making seawater drinkable; 8) epidemic jaundice experiments to investigate causes of and inoculations against epidemic jaundice; 9) typhus ("spotted fever") and other vaccine experiments to test the effectiveness of vaccines against typhus, smallpox, cholera, and other diseases; 10) poison experiments to investigate the effect of various poisons, including poison in food and poisoned bullets; 11) sterilization experiments to develop methods of rapid, large scale sterilization in order to ensure the eventual elimination of "enemy" populations while keeping captive workers as a labor force during the war; 12) skeleton collection for an anatomical research project at the reich university of strasbourg, 112 jews at auschwitz were killed for the purpose; 13) phenol (gas oedema) experiments to investigate whether levels of phenol in gas oedema serum caused fatalities among wounded soldiers; and 14) polygal experiments to test the effectiveness of polygal, a blood coagulant, for the treatment of wounds. 117 in one example, phr admits the evidence available to it does "not demonstrate that the experimental regime employed on detainees came complete with stated hypotheses, methodology, results, and conclusions-the fundamental elements of all legitimate scientific investigation." phr, experiments in torture, supra note 113, at 7. vol. 11:1172 legal but unethical knowledge rather than therapy."us8 this focus on purpose is not to suggest that ends testing appropriately distinguishes the nazi doctors from united states health providers-what the nazi doctors were actually doing is also dramatically different from what united states hps were doing-but rather to demonstrate that what united states hps were doing simply did not constitute medical experiments. a. law like general and specific planning discussed above, no specific law prohibits hps from participating in intrainterrogation consultation, meaning criminal legal liability for intra-interrogation consultation would rely on theories of secondary liability. the possibility of accomplice liability seems high, assuming the activities recommended by the mhps constituted violations of law, as the direct, real-time provision of advice to employ a particular technique would certainly meet the required mens rea and actus reus elements of accomplice liability. to the extent that hp involvement in intra-interrogation consulting converted the interrogations to medical experiments-a contention that seems plainly wrongconducting non-consensual "medical experiments" on detainees would be, without question or equivocation, a 11s m. cheriff bassiouni, an appraisal of human experimentation in international law and practice: the need for international regulation of human experimentation, 72 j. crim. l. & criminology 1597, 1597 (1981) (emphasis added). introduction to nmt case 1: usa. v. karl brandt et al., nuremberg trials project: a digital document collection, harv. l. sch. libr., http://nuremberg.law.harvard.edu/php/docs_swi. php?di=1&text=medical#indictments (last visited dec. 23, 2013). similarly, professor george annas, a distinguished bioethicist and legal scholar-and no apologist for enhanced interrogation techniques or hps' assistance in them -acknowledged the activities phr alleges constitute "experiments" or "research" do not actually constitute research, in part because the activities "do not follow the national institutes of health definition of research, which includes having a hypothesis andat least a historical control group." lewis, supra note 19 (emphasis added). annas also observes the debate over experimentation is a red herring, saying, "[i]t misses the point to call it research. it's torture and there's no reason to dignify it as research." id. 2014 173 indiana health law review violation of numerous international and domestic laws, including several of the geneva conventions and the wca.119 perhaps it is these clear legal prohibitions that entice some commentators to make the as-yet unsupported claim that united states hps conducted medical experiments. while some of the shameful interrogation techniques employed by the united states may have been 119 see, e.g., geneva i, supra note 15, at art. 50; geneva iii, supra note 15, at arts. 13, 14, 130; geneva iv, supra note 15, at arts. 32, 147; iccpr, supra note 48, at art. 7; 18 u.s.c. § 2441(d)(1)(c). as noted above, the amended wca also bans biological experiments on detainees, but unlike geneva iii's prohibition, does so only if the experiment "endangers the body or health of such person or persons." thus, it is theoretically possible "experiments" could violate geneva but not the wca if they did not endanger the subject of the experiment. moreover, several international ethical norms likely have attained the status of customary international law. see, e.g., nuremberg code, supra note 17; declaration of helsinki, supra note 27; see also jennifer seo, raising the standard of abortion informed consent: lessons to be learned from the ethical and legal requirements for consent to medical experimentation, 21 colum. j. gender & l. 357, 375 (2011). additionally, a united states federal statute codifies the prohibition of conducting human experiments on non-consenting subjects, though it enforces that prohibition through withholding of funds not applicable to the activities addressed in this paper. see 42 u.s.c. § 3515b (2013) (prohibiting funds appropriated to the departments of labor, health and human services, education, or related agencies from being used on research programs involving experiments with non-consenting human subjects). a policy regulation issued by the department of health and human services, also prohibits experiments without the subject's consent. see 45 c.f.r. §§ 46.101-.119 (2013) (requiring informed consent before conducting experiments on human subjects except in very limited circumstances not applicable here). this regulation was adopted by dod. see dodd 3216.2, supra note 25. additionally, numerous executive orders have specifically prohibited the practice of engaging in human experiments by united states intelligence agencies. see, e.g., exec. order no. 12,333 § 2.10, 46 fed. reg. 59941 (dec. 4, 1982) (requiring written informed consent for any human experimentation by an agency within the intelligence community). of note, at least one intelligence-related experiment program that would run afoul of several laws has become known. see daniel l. pines, the central intelligence agency's 'family jewels"legal then? legal now?, 84 ind. l.j. 637, 645 -646 (2009). this program involved administration of lsd and other drugs to united states citizens without their knowledge and consent for the purpose of building a defense to feared soviet drug-based attacks. id. 174 vol. 11: 1 legal but unethical illegal, they simply did not constitute medical experiments. such unjustified shoehorning leads to the problem, the consequences of which are discussed below, of suggesting that the law prohibits certain behaviors when it does not. b. ethics international and domestic ethical standards that prohibit facilitating interrogation such that involvement in specific interrogation planning is disallowed obviously also prohibit intra-interrogation consultation. as noted above, in 2006, the wma, ama, and american psychiatric association prohibited facilitating specific interrogation. the ama specifically insists physicians not "directly participate" in interrogation, though it fails to define "directly," leaving some question as to whether providing stand-off consultation to interrogators would be permissible.120 the american psychiatric association also prohibits "direct participation" in interrogation, defining it as "being present in the interrogation room, asking or suggesting questions, or advising authorities on the use of specific techniques of interrogation with particular detainees." clearly all forms of contemplated intrainterrogation consultation would constitute "direct participation" under this standard. by contrast, psychologists are not completely prohibited from participating in interrogations, including intrainterrogation consulting. the apa only prohibits involvement in interrogation involving torture or cruel, inhuman, or degrading treatment or working in settings where persons are "held outside of or in violation of international law or the united states constitution."12 1 in fact, the 2006 apa resolution against torture provision 120 ama opinion 2.068, supra note 29, para. 2. ama opinion 2.068 does include an apparently non-exclusive example of "direct participation": monitoring interrogations "with the intention of intervening in the process." id. at para. 3. 121 2006 apa resolution against torture, supra note 32; 2008 apa resolution against torture, supra note 33; apa resolution on detainee settings, supra note 88. 2014 175 indiana health law review that requires psychologists, "if present when torture or cruel, inhuman, or degrading treatment occurs to try to stop the abuse or exit the procedure"; this suggests psychologists might be present at interrogations. 122 thus, whether a psychologist may ethically engage in intra-interrogation consulting depends on the actions of the interrogators. again, were hps' conduct to be considered non-consensual medical experimentation, a variety of ethical standards clearly prohibit nonconsensual experimentation. 12 3 3. examples. health evaluations and interrogation monitoring mhps have regularly conducted examinations of detainees before and after interrogation and monitored detainee health during some interrogations. these activities are distinguished from general medical and mental treatment discussed below because the alleged purpose of the examinations and monitoring is to determine the suitability for initiating, continuing, or resuming interrogation. in fact, as described above, dod policy required medical screening before detainees could be subjected to several of the interrogation methods approved by secretary rumsfeld, including waterboarding, solitary confinement, sleep deprivation, stress positions, and dietary manipulation, and in some cases required monitoring during the use of the techniques. 124 examples of preand post-interrogation health assessments are available from multiple theaters of operations. for example, according to the interrogation logs, military physicians frequently monitored qahtani's physical condition during the weeks of interrogation, 122 2006 apa resolution against torture, supra note 32. 123 see, e.g., nuremberg code, supra note 17; declaration of helsinki, supra note 27. 124 see, e.g., rumsfeld approval memorandum of april 2003, supra note 10. vol. 11:1176 legal but unethical "sometimes as often as three times a day . . ". 125 in iraq, one air force medical team reported examining "each abu ghraib detainee before and after interrogation." 126 in fact, the air force team, which consisted of one physician, one physician's assistant, and two medics, "provided initial medical assessments of detainees to determine preexisting conditions that might affect the interrogation process; it was also tasked with completing pre-, trans-, and postinterrogation medical assessments on an individual basis, at the request of the interrogators." 127 in addition to preand post-interrogation assessments, some hps have been involved in assessments or monitoring during the use of interrogation techniques. for example, interrogated detainees in iraq were monitored by air force doctors during use of the sleep deprivation technique. 128 additionally, detainees alleged "hps examined their condition during an episode of torture or physical abuse but, as far as the detainees could tell, made no effort to stop it."129 finding details of how frequently hps have been involved in monitoring is difficult, though the 2005 army surgeon general's assessment clearly demonstrates hps were periodically present during questioning of detainees. of sixty-six interviewed mhps who had served in afghanistan, seven had been physically present during an interrogation, though none had "participated" in an interrogation.130 of the nine interviewed mhps who had served at guantanamo, none reported having been present during interrogation. 131 finally, in iraq, 39 of 777 interviewed mhps had been present during at least one 125 adam zagorin & michael duffy, inside the interrogation of detainee 063, time, june 20, 2005, at 26, 27. 126 miles, supra note 3, at 51. 127 army surgeon general assessment, supra note 55, at 11-2. 128 sworn statement of [name redacted], 519th military intelligence battalion 5 (may 19, 2004) (noting the purpose of the monitoring was to ensure detainees were not harmed), available at http://www.aclu.org/files/projects/foiasearch/pdfldod000867.pdf. 129 hashemian, et al., supra note 6, at 86. 130 army surgeon general assessment, supra note 55, at 18-18. 131 id. at 18-19. 2014 177 indiana health law review interrogation.132 five had participated in the interrogation, with two serving as translators, two medics directly asking questions of detainees (because of arabic fluency or rapport with detainees), and one physician reported feigning evaluations and treatment on detainees by pretending to do dna tests from a hair sample and a buccal swab.133 a. law as with many of the activities discussed in this article, no law specifically prohibits hps from conducting medical or mental health evaluations before, during, or after interrogation, meaning whether such evaluations would violate law depends entirely on secondary liability theories. in addition to the lack of legal proscription, the legality of medical monitoring or evaluations before, during, or after interrogation sessions is complicated by the fact that some law requires medical evaluation and treatment of detainees. for example, geneva iii, article 15, requires the detaining power to provide to prisoners of war the "medical attention required by their state of health." though it may seem specious to argue medical exams are required by detainees' poor state of health when the detaining power is responsible for creating that state of health, no derogation from article 15's requirement is provided. surely, if an interrogator--or even a prison guard in a non-interrogation settingcommits a plainly illegal battery on a detainee, medical evaluation must be conducted, whether or not that evaluation is followed by further interrogation. b. ethics as noted previously, the revised declaration of tokyo now explicitly forbids physicians to use their knowledge to facilitate any interrogation, raising the significant question of whether conducting a medical examination or monitoring "facilitates" the interrogation. 134 moreover, the wma 132 id. at 18-21. 133 id. at 18-21 through -22. 134 revised declaration of tokyo, supra note 27. 178 vol. 11: 1 legal but unethical regulations in times of armed conflict explicitly states it is unethical for a physician to perform diagnostic procedures "not justifiable for the patient's health care," suggesting that evaluations to determine whether an individual could withstand further interrogation-and not for the purpose of improving that patient's physical condition-are impermissible.135 domestic ethical standards are less clear regarding evaluations and monitoring interrogation. 136 for example, the ama allows physicians to perform physical and mental assessments of detainees to determine the need for and provide medical care, as long as they "disclose to the detainee the extent to which others have access to information included in medical records." therefore, under the ama's standards, conducting medical and mental health evaluations is permissible so long as it is to determine the need for medical care. this raises the question of dual purposes. if the physician is conducting the evaluation both genuinely to determine the detainee's need for medical care and to give a clean bill of health that allows interrogation to continue, has the ama position been violated? neither the american psychiatric association nor the apa has specifically addressed medical monitoring or mental health evaluations. as in other areas, evaluations and monitoring pose difficult questions regarding secondary liability for hps. one of the purposes for having hps monitor interrogations is to determine whether the implementation of a technique crosses the threshold of severity ("severe physical or mental pain") that would make it a violation of law. if the health 135 w1via regulations in times of armed conflict, supra note 27. 136 this "nuance" applies only to the more generalized question of monitoring for interrogation. the ama's position regarding monitoring torture is crystal clear. ama's opinion 2.067, entitled "torture," enacted in december 1999 and, thus, applicable throughout the gwot, provides that physicians may treat detainees if doing so is in the best interest of the detainees' health, "but physicians should not treat individuals to verify their health so that torture can begin or continue." thus, here, as elsewhere, whether a physician's medical assessments constitute a violation of medical ethics depends upon whether the underlying activity constitutes torture. 2014 179 indiana health law review professional incorrectly finds the technique will not cause severe physical or mental, has she or he aided or abetted commission of crime? more basically, if medical monitoring is required by policy, does not the provision of that monitoring "facilitate" the interrogation? indeed, one could argue it is legally necessary for the interrogation to continue. if the health professional's opinion is that the detainee is capable of withstanding further interrogation, it seems liability would depend on whether the subsequent interrogation was illegal, something over which the health professional is unlikely to have control. c. general medical care article 15 of geneva iii requires detaining powers to provide to prisoners of war "medical attention required by their state of health."137 in the gwot, detainee healthcare has been provided by mhps who are generally unassociated with interrogation operations. however, even this purportedly distinct provision of care has given rise to allegations of involvement in interrogation and torture. for much of the gwot, the department of defense has established a separation between hps involved in interrogation and intelligence collection activities and those responsible for the general medical and mental welfare of the detainee population. indeed, in its final regulatory codification of this dichotomous vision, perhaps in an implicit acknowledgment of professional ethical standards, dod provided: "health care personnel engaged in a professional provider-patient treatment relationship with detainees shall not participate in detainee-related activities for purposes other than health care. such health care personnel shall not actively solicit information from detainees for other than health care purposes." 138 however, as noted above, even hps who were separately responsible for general medical care at the detention facility, and were not involved in "detainee-related activities for purposes other than health care" (i.e., interrogation), are 137 geneva 111, supra note 15. 138 dodi 2310.08e, supra note 2. 180 vol. 11:1 legal but unethical alleged to have "enabled torture" for failing to notice or report injuries indicative of abuse, deliberately concealing abuse, withholding care to obtain information, providing medical or mental health care for the purpose of furthering interrogation, forced feedings of detainees, and sharing confidential medical information with interrogators. indeed, one critic has alleged hps became enablers of torture merely by "providing medical care in an environment where torture was taking place."139 1. examples: failure to identify or report evidence of interrogation -relatedabuse health personnel have been criticized for failing to notice and report interrogation-related injuries, allowing abusive interrogations to continue. 140 however, specific instances of hps otherwise unassociated with interrogation failing to identify or report evidence of interrogation-related abuses are difficult to find. though there are some vaguely reported instances of hps failing to notice or report instances of physical or psychological harm detainees suffered, it is not clear whether those abuses were interrogation-related. 141 139 hashemian et al., supra note 6, at 85-86. 140 this suggests such personnel could distinguish between interrogation-related abuses and non-interrogation-related abuses, which seems unlikely. for example, abuses of detainees at abu ghraib have been well documented, but not all abuses of detainees are interrogation-related. christopher graveline & michael clemens, the secrets of abu ghraib revealed 299 (2010) (observing that "the vast majority, and most notorious, photographs of abuse [at abu ghraib] had nothing to do with intelligence collection. many of the victims, plain and simple, were not terrorists or even interrogated"). this book, authored by individuals involved in the investigation and prosecution of united states military personnel involved in the atrocities at abu ghraib, offers an extraordinarily intimate and seemingly objective view of the abu ghraib nightmare and subsequent response. see also army surgeon general assessment, supra note 55, at 14-2 (noting injuries can be due to lawful combat operations and lawful physical force required to maintain discipline in a detention facility). 141 the church review cites one such example, where detainees died and physicians found "no evidence of bruising or injury" but autopsies days later "revealed massive blunt force injuries to the legs, 2014 181 indiana health law review that physical abuses have occurred in the course of interrogations of detainees is clear.142 it is reasonable to assume some of these detainees were taken to detention facility medical units to obtain medical care. however, there are a host of legitimate reasons why health professional might not report suspicious injuries as evidence of interrogation-related abuses. first, it is not at all clear hps can distinguish between interrogation-related and noninterrogation-related injuries (that may have been selfinflicted, caused by other detainees, or caused before the individual was even detained). second, the health professional might not recognize the injury as suspicious. 143 finally, the patient may request that the injury not be reported. none of these situations excuse hps from reporting if they actually believe the injuries were caused by abusive interrogation, but they do explain why some injuries may not have led to a report. further, it may be difficult for hps to demonstrate when they did champion a detainee's health, only to be dismissed by interrogators. 144 further, it is entirely possible with muscle injury so severe that bilateral leg amputations would have been necessary if the detainee had survived." church review, supra note 111, at 363. the church review continued, "review of these cases with [the medical examiner] support our concern that local physicians may have misrepresented, either consciously or due to incomplete examinations the condition of these detainees at death." id. the distinction between abusive interrogation and other abuses (such as by personnel capturing the detainees or by detention facility guards) is relevant to this article, because it is about interrogationrelated activities. the distinction is likely irrelevant under the law or ethical guidelines mandating reporting. 142 the smutf-iraq legal advisor told a visiting assessment team from guantanamo about physical violence being used by smutf personnel during interrogations, including punching, choking, and beating detainees. sasc report, supra note 44, at 193. 143 "failure to report" may involve a predicate concern: the failure to identify evidence of torture. moreover, allegations of failure to identify raise the question of whether the failure was negligent or intentional. 144 in one such instance, a psychology technician at gtmo complained to the cell block officer-in-charge about the officer's refusal to allow a detainee to be seen by medical personnel for back pain, to which the officer-in-charge purportedly replied: 182 vol. 11:1 legal but unethical interrogation-related abuses regularly were reported by hps and that such reports, like so many other facts in this area, remain classified. according to the commander of the medical unit that staffed abu ghraib during the time of the abuses made notorious by soldiers' photographs, "military intelligence personnel told his medics and physician assistants not to discuss deaths that occurred in detention." 145 in one instance, two physicians at abu ghraib allegedly "recognized that a detainee's shoulder was hurt because he had his arms handcuffed over his head for what they said was 'a long period."' 146 the two physicians provided palliative care, then sent the detainee to a non-united states hospital, and did not report any suspicions of abuse.147 physical injuries are not the only types of injuries reportedly ignored by hps; mental health injuries also allegedly escaped notice and reporting. phr alleges hps at guantanamo "provided pharmacological treatment for suicidal, self-destructive, and partly psychotic behavior that is at least partially attributable to the torture-including isolation-the detainees experienced, yet the health providers only marginally intervened to stop his torture."1 48 further, according to phr, by identifying "routine stressors of confinement," as causes for the detainee's mental health problems, the involved psychiatrists "disregarded cruel or ill-treatment as a likely cause of these symptoms." 149 listen, bitch, i run this cellblock the way i see fit. if i think a detainee is complaining about back pain just to get to walk across the camp to the medical clinic one sunny afternoon, then i'm not going to put it in my log. now leave my block and next time stay in your lane. erik saar & viceca novak, inside the wire 73-74 (2005). 145 m.g. bloche & j.h. marks, doctors go to war, supra note 10, at 4. 146 kate zernike, the reach of war. the witnesses; only a few spoke up on abuse as many soldiers stayed silent, n.y. times, may 22, 2004, at al. 147 id. 148 hashemian et al., supra note 6, at 86. 149 id. 1832014 indiana health law review relying on these facts, phr concluded that "[i]n sum, the hps were complicit in the torture of this detainee."150 in contrast to the assertions of non-reporting by commentators, the army surgeon general's assessment conducted in 2005 asked hps who had served or were serving in iraq, afghanistan, and at guantanamo about their reporting of suspected abuses. of 798 interviewed mhps who had served at detention facilities in afghanistan, guantanamo, and iraq, forty-three indicated detainees had reported abuse to them, and the health professional had reported all but four instances of alleged abuse.15 1 of the four who indicated they did not report the abuse, three were because the health professional thought the claim lacked credibility and one believed he or she lacked sufficient information. 152 five hundred ninety-six mhps who had served at detention facilities in afghanistan, guantanamo, and iraq were asked whether they personally observed signs of possible abuse.153 thirty indicated they had; 25 reported that abuse.154 of the five unreported cases, the army surgeon general's assessment indicated three were because action was otherwise taken.155 a. law a legal duty to report various abuses is not strange to hps, who operate under state laws requiring reporting in various circumstances.15 6 however, at the inception of the 150 id. 151 army surgeon general assessment, supra note 55, at 16-1 n.2. 152 id. at n.3. 153 id. at n.2. 154 id. at n.3. 155 id. the other two were unexplained. 156 an interesting corollary is the many state statutes, rigorously adhered to by mhps in the united states, that mandate reporting when hps suspect child or spousal abuse. for example, the united states department of health and human services reports forty-eight states have laws mandating medical professionals report child maltreatment. child welfare information gateway, mandatory reporters of child abuse and neglect: summary of state laws (apr. 2010), available at http://www.childwelfare.gov/systemwidellaws-policies/statutes/manda.cf 184 vol. 11:1 legal but unethical gwot, no clear law required reporting interrogationrelated abuses. 16 7 contrary to popular perception, service members do not have a general duty to report any violation of which they are aware. rather, the duty must be specifically imposed.15 8 additionally, such a duty would not arise where mandatory reporting would violate the service member's rights against self-incrimination (for example, if the service member were an accomplice to the alleged crime). 159 further, after the approval of various harsh interrogation techniques by the bush administration, involved service members understandably might have assumed no duty to report was implicated when detainees sustained physical or mental injuries that purportedly resulted from authorized interrogation procedures. fortunately, whatever ambiguity might have existed at the beginning of the gwot regarding the duty to report suspected abuse was eventually resolved. dodi 2310.08e, paragraph 4.5, imposed a clear burden on mhps to report any observed or suspected violations of united states law to the chain of command. further, it prescribed alternative reporting avenues if the health professional believed the chain of command was not acting properly on the report. thus, after the promulgation of dodi 2310.08e in 2006, and so long as it remains in effect, there should be no question regarding the duty to report suspected abusive interrogation. m. by contrast, no such statutory requirement, at the state or federal level, to report suspected torture is imposed on hps as a profession. 157 army medical command legal guidance apparently, imposed a reporting requirement, but not until well after alleged interrogation abuses began. see army surgeon general assessment, supra note 55, at 15-2, 16-2 (citing health care professional detainee abuse reporting requirements (sept. 8, 2004)). 158 see united states v. heyward, 22 m.j. 35, 36 (c.m.a. 1986) (stating a duty to report must be specifically imposed and noting the offenses of being an accessory after the fact and misprision of a felony require affirmative acts of concealment or assistance in addition to failure to report). 159 see kastigar v. united states, 406 u.s. 441, 445 (1972). 2014 185 indiana health law review b. ethics while physicians, including psychiatrists, and psychologists have a duty to report ethical violations of fellow professionals, like the law, professional associations were late in clarifying the duty to report as it applied to suspected interrogation-related abuses. ama opinion 2.068, promulgated in 2006, stated physicians must report "coercive interrogations" to appropriate authorities and if such authorities are aware of such interrogations but have not intervened, they must report the offenses to other authorities with the power to investigate or adjudicate the allegations. the american psychiatric association, on the other hand, only requires psychiatrists to report when they become aware "torture" has occurred. the apa imposes no specific duty to report specific to torture or interrogation. application of these ethical standards is difficult because whether particular abuses were caused by interrogation or torture-thus implicating the ethics rules-would be difficult to ascertain. 2. examples: concealing interrogation -related injuries going a step beyond the omissions of failing to identify and report interrogation-related abuse, some have asserted hps were engaged in affirmative efforts to conceal detainee abuse. publicly available evidence of this alleged practice is virtually non-existent. one notorious, although only partially relevant, incident involved concealing the death of a detainee ostensibly caused by injuries. 160 after capturing manadel al-jamadi, navy seals allegedly beat and kicked him prior to turning him over to cia personnel for interrogation at abu-ghraib. 161 after several hours of interrogation, mr. jamadi died and his body was packed in 160 this instance of alleged concealment did not relate to interrogation-related detainee abuse, but is included to demonstrate the type of activity one might argue constituted deliberate concealment by medical personnel. 161 david s. cloud, seal officer's trial gives glimpse of cia. role in abuse scandal, n.y. times, may 26, 2005, at a13. vol. 11:1186 legal but unethical ice. before leaving the facility, a medic inserted an iv in mr. jamadi's corpse and the body was rolled out of the facility on a medical gurney. the intent of the medical personnel is unclear. while vice admiral church's investigation found that "medical personnel may have attempted to misrepresent the circumstances of death, possibly in an effort to disguise detainee abuse," the subsequent army surgeon general's investigation of the matter accepted the explanation of the commander overseeing the interrogation that the ruse was to avoid upsetting other detainees. 162 a. law though there are no laws specifically addressing such concealment in the context of interrogation, let alone specifically prohibiting medical providers from engaging in such subterfuge, deliberate concealment of illegal activity by service members is itself illegal.163 however, while there may be evidence that possibly suggests some hps failed to take appropriate action in response to apparent interrogation-related abuse, there simply is no publicly available evidence that mhps engaged in deliberate concealment. b. ethics as with the law, though there are no specific ethics provisions that prohibit concealing illegal forms of interrogation, concealment clearly constitutes facilitation. thus, the various ethical standards discussed above that 162 army surgeon general assessment, supra note 55, at 20-5; church review, supra note 111, at 21; see also miles, supra note 3, at 45 (asserting the armed forces institute of pathology's failure to provide the results of the autopsy and the death certificate to the icrc or mr. jamadi's family constituted further concealment of the homicide). 163 see, e.g., 10 u.s.c. §§ 878, 934 (2013) (criminalizing acts of concealment by accessory after the fact and criminalizing "misprision of a serious offense"). 2014 187 indiana health law review prohibit facilitation of interrogation or torture would clearly prohibit concealment of the same. 164 3. examples: withholding care to obtain cooperation another situation in which "general medical care" has been alleged to constitute actual involvement in interrogation is when medical care is withheld until the individual being interrogated cooperates and provides information. allegations to this effect have generally ignored the critical (for purposes of this article) fact that health professionals were not the individuals denying or withholding the care. 165 actual evidence of hps withholding medical care from detainees for noncooperation is exceedingly difficult to find. the idea that medical care could be withheld to further interrogation purposes was directly acknowledged by the most senior dod official when, in december 2002, secretary rumsfeld authorized, as a "category ii" interrogation technique, isolation of individual detainees, during which "medical visits of a non-emergent nature" were within the discretion of the officer-in-charge of interrogation. 166 withholding medical or mental health care to obtain cooperation in interrogation is clearly a violation of law. common article 3 demands "the wounded and sick shall be cared for." geneva iii requires the detaining power to provide to prisoners of war "medical attention required by their state of health,"167 states that "[p]risoners of war may not be prevented from presenting themselves to the medical 164 see, e.g., wma regulations in times of armed conflict, supra note 27, para. 2(e); revised declaration of tokyo, supra note 27; ama opinion 2.068, supra note 29. 165 see, e.g., hashemian et al., supra note 6, at 85. 166 memorandum from william j. haynes ii, gen. counsel for department of defense, to donald rumsfeld, secretary of defense, counter-resistance techniques (nov. 27, 2002) [hereinafter rumsfeld approval memo of nov. 20021, available at http://www.dod.mil/pubs/foil operation andplans/detainee/additionaldetaineedocuments/07-f2406%20doc%201.pdf. 167 geneva iii, supra note 15, art. 15. 188 vol. 11:1 legal but unethical authorities for examination," 168 and prohibits subjecting pows to "disadvantageous treatment of any kind" for failure to answer questions, 69 and it prohibits endangering the health of a pow.170 clearly, secretary rumsfeld's 2002 decision that guantanamo interrogators could disapprove a detainee's "medical visits of a non-emergent nature" violated these provisions (to the extent they applied).171 nothing in the cited provisions of the geneva conventions limits a detaining power's responsibility to provide medical care to detainees only in emergency situations. though some critics allege hps were directly involved in the withholding of care in exchange for information, it seems more likely that access to hps would be withheld by interrogators, rather than hps interacting with sick or injured detainees and choosing not to treat them.172 in fact, no specific cases of health professionals withholding care for the purpose of obtaining cooperation in interrogation have been reported. indeed, secretary rumsfeld's memorandum suggests the interrogation team, not hps, would determine whether detainees would get such access to non-emergent care. though this article focuses on mhps and military detention and interrogation, it is illustrative in this context to note the cia considered the act of withholding pain 168 id. at art. 30. 169 id. at art. 17. 170 id. at art. 13. 171 rumsfeld approval memo of nov. 2002, supra note 166. of course, guantanamo detainees were determined not to be entitled to the protections of geneva iii. however, applying that decision in cases where geneva iii might have applied, such as in iraq, would clearly have been contrary to geneva iii. 172 see, e.g., brewer & arrigo, supra note 7, at 8 (reporting a specific example where a non-cooperative detainee was offered pills to cure their dysentery, but only if they provided information, and arguing "commanders may simply order medical personnel to place their loyalty to country above their medical care for a detainee, including by trading medical treatment for information during interrogations"); hashemian et al., supra note 6, at 85 (noting that a detainee complained of being denied medical care "due to a perception that he was not cooperating with officials" and he had to ask to see a doctor more than ten times before he was referred for care). 2014 189 indiana health law review medication until a detainee cooperated to constitute an "enhanced interrogation technique." 173 at least one instance of cia use of this method has been documented. after abu zubaydah was shot in the groin during his capture, "painkillers were used selectively in the beginning of his captivity until he agreed to cooperate more fully" with interrogators. 174 even in this instance, it is difficult to discern whether medical personnel were involved in the withholding of painkillers, though the fact he was receiving some medical treatment at the time suggests it is at least possible medical personnel were, at a minimum, aware pain relieving medication was being withheld.175 though unclear which agency was responsible, another detainee reported he was denied medical care for a gunshot wound in his shoulder because he refused to cooperate with interrogators while he was "tortured" for three days after capture in afghanistan, with interrogators implying he could receive treatment after cooperating. 76 other cases of denied or delayed medical care pending detainee cooperation with medical care include denial of antibiotics for festering wounds and treatment for constipation.17 7 perhaps because the practice is so clearly prohibited by law and ethical standards, virtually no evidence has been produced that these allegations-medical and mental health providers withholding necessary care to obtain cooperation in interrogation-actually occurred in united states military detention facilities. as noted above, it is alleged that abu zubaydah received delayed care after being shot in the groin, but there is no evidence health professionals were involved in the delay. 173 dana priest, cia puts harsh tactics on hold, wash. post (jun. 27, 2004), at a01. 174 id. 175 miles, supra note 3, at 61 (quoting secretary rumsfeld, referring to abu zubaydah, as saying, "he is receiving medical care and we intend to get every single thing out of him to try to prevent terrorist acts in the future."). 176 fbi interview memo (sept. 5, 2002) (bates-stamped detainees-3894), http://wwwl.umn.edu/humanrts/oathbetrayed/ fbi%203890-3927.pdf. 177 miles, supra note 3, at 62. 190 vol. 11:1 legal but unethical a. law if a service member or other person acting on behalf of the united states were to prevent pows from presenting themselves for medical examination, that would constitute a breach of the united states' treaty obligations under common article 3 and geneva iii. however, it is important to note that, as a factual matter, it is unlikely health professionals-rather than individuals actually in control of detainees-would be preventing pows from presenting themselves for medical examination. in the example recounted in note 143 above, it was the interrogators who denied access to medical care (telling the health professional to "stay in your lane"). this makes sense for several reasons: the detainees are under the physical control of the detention team or interrogation team, not the hps; the detainees are physically separated from the hps; and the hps (other than the bsct members, who do not provide treatment) typically would have no idea whether or not the detainee is being cooperative in interrogation. b. ethics one professional association articulated an ethics standard expressly prohibiting conditioning treatment on a patient's participation in an interrogation. ama opinion 2.068 states that "[t]reatment must never be conditional on a patient's participation in an interrogation." 178 additionally, if engaged in by hps, withholding medical care for the purpose of obtaining cooperation clearly would constitute "facilitation" of interrogation prohibited by various ethical standards, as discussed above. 179 178 ama opinion 2.068, supra note 29. 179 see, e.g., id. at para. 2; revised declaration of tokyo, supra note 27. 2014 191 indiana health law review 4. examples: providing care for the purpose of furthering interrogation critics have accused united states mhps of providing medical care for the primary or sole purpose of enabling further interrogation. the factual basis for such assertions remains elusive, in large part because even in the unusual circumstance where some information regarding a detainee's medical care is available, it is difficult to determine the intent in providing medical care to detainees suffering from the physical or mental effects of their detention and interrogation. for example, qahtani became very ill at one point during his extended interrogation.18 0 a military physician reported qahtani's heart rate dropped to thirty-five beats a minute, apparently due to hypothermia caused by intentionally extreme air conditioning. 181 significant medical efforts were undertaken, including flying a radiologist to guantanamo from puerto rico to review ct scans. 182 ultimately, the interrogation resumed. 183 whether the involved hps were simply fulfilling their duty to alleviate his suffering and improve health or, as critics assert, patch him up for the purpose of allowing interrogation to continue cannot be determined with available information. the extraordinarily comprehensive investigation conducted at the direction of the surgeon general of the army in 2005 uncovered little evidence of providing medical care for the purpose of allowing interrogation to continue. of 438 interviewed hps who had served in iraq, seven reported having been "asked to provide medical care to detainees during interrogations so that the interrogations could be continued," with each having done so only once. 184 180 see mayer, supra note 79, at 68. 181 zagorin & duffy, supra note 125, at 32; miles, supra note 3, at 61. 182 zagorin & duffy, supra note 125, at 32. 183 miles, supra note 3, at 61. 184 army surgeon general assessment, supra note 55, at 11-2. interestingly, none of the air force team members involved in the interrogation screenings at abu ghraib were asked to provide medical care to detainees during interrogations so that the interrogations could vol. 11:1192 legal but unethical examples of the care delivered include providing food for hypoglycemia and intravenous fluid administration for symptoms of dehydration. 185 no interviewees who had served in afghanistan or guantanamo reported being asked to provide medical care during interrogations so that the interrogations could be continued or being aware of other medical personnel who were asked to do the same.186 interrogation-caused injuries followed by medical care followed by further interrogation simply does not mean hps were providing the medical care for the purpose of allowing interrogation to continue. critics asserting hps were providing health care for the purpose of allowing interrogations seem unfazed by these evidentiary gaps. one civilian psychiatrist who visited guantanamo reviewed treatment logs and concluded the detainees were given "decent medical care," but she noted that this care was administered for the primary purpose of preparing individual detainees for additional harsh interrogations. 187 she provided no detailed basis for that conclusion. in one specific instance involving a detainee at guantanamo, who began showing severe symptoms of mental distress, mental health providers treated the detainee with psychotropic medication, but, according to phr, "only intervened once, three months after his symptoms appeared" to alleviate isolation they believed worsened the detainee's condition. the detainee had been subjected to stress positions and isolation for several weeks and began exhibiting symptoms of severe mental distress including hallucinations, banging his head against a wall, and attempted suicide. 188 apparently on this evidence alone, phr concluded the providers "became complicit in his torture, essentially continue. they reported that "[ilf medical care was needed for detainees during an interrogation, the interrogation was stopped, treatment was rendered, and the interrogation did not continue." id. 185 id. 186 id. at 11-1. the assessment did not provide the total number of interviewees in afghanistan and at guantanamo who answered questions about providing medical care for the purpose of allowing interrogations to continue. 187 sands, supra note 101, at 161-68. 188 hashemian et al., supra note 6, at 86. 2014 193 indiana health law review patching him up in order for him to be subjected to further ill-treatment."8 9 a. law no law prohibits providing medical care for the purpose of furthering interrogation. when one considers the circumstances in which such an allegation could arise, this makes sense. prohibiting medical care that allows further interrogation would mean medical care that is otherwise necessary would be disallowed. ostensibly, for medical care to be "for the purpose of furthering/allowing further interrogation," the detainee's medical condition would be so dire the detainee could not withstand the contemplated interrogation technique without it. under such circumstances, how could not. providing medical care be required by law? there is little law governing the motivation or purpose for which medical or mental health care is provided to detainees. 190 geneva iii, article 13's prohibition on endangering the health of a pow is the closest law on the issue, but raises as many questions as it answers. for example, some may argue that providing care to a detainee that allows the detainee to be returned to aggressive interrogation inherently endangers them. on the other hand, if a detainee needs medical care, regardless of the reason for that need, not providing the care endangers the detainee. in any case where medical care is provided, at least a purpose of providing the care is because it is necessary for the detainee's health. no case has been presented where medical care has been provided to allow further interrogation and there has not also existed an independent need for medical treatment. such a situation would necessarily entail elective medical care, and while the 189 id. (emphasis added). 190 see supra part iii. as discussed above, common article 3 and geneva iii require that medical care be provided to detainees who need it. none of those provisions require any particular motivation, or lack of motivation, for providing the care. 194 vol. 11.1 legal but unethical creativity of the wicked mind is limitless, it strains the imagination to envision elective medical care that would be necessary to allow further interrogation. thus, even a case where a health professional is alleged to have provided care for the purpose of furthering interrogation will necessarily include an alternate legitimate purpose of providing care that is medically indicated. b. ethics while some ethical standards flatly prohibit evaluations or monitoring for the purpose of allowing further interrogation to continue (for example, ama opinion 2.068's prohibition on certifying fitness of detainees for further interrogation), none prohibit providing healthcare that has the incidental effect of allowing interrogation to continue. while concerns regarding the facilitation of interrogation-prohibited, as noted above, by several ethical standards-are likely raised when a health professional provides care that allows interrogation to begin or continue, when the care has an independent, legitimate, and perhaps ethically compelled purpose (alleviating the patient's suffering), it is difficult to understand how it could nevertheless be unethical to provide the care. moreover, the ama's position that physicians may perform physical and mental assessments of individuals undergoing interrogation "to determine the need for and to provide medical care," demonstrates at least the ama believes providing care to detainees being interrogated is appropriate. 5. examples.' forced feeding in an area related to providing care for the purpose of allowing interrogation to continue, forced feeding of detainees by mhps has drawn significant criticism. 191 191 see, e.g., george annas, hunger strikes at guantanamomedical ethics and human rights in a "legal black hole," 355 new eng. j. med. 1377 (2006); scott a. allen & hernan reyes, clinical and operational issues in the medical management of hunger strikes, in interrogations, forced feedings, and the role of health 1952014 indiana health law review forced feeding has been the subject of articles and books, and this article cannot address all the issues associated with mhps force-feeding detainees. however, some discussion is appropriate, because this is an area where ethical standards, as pronounced by professional associations, have clearly addressed an issue the law has not. forced feeding of detainees at guantanamo clearly occurred.192 indeed, the details of the forced feedings at guantanamo, which used restraint chairs, can be shocking. one detainee made this report: the head is immobilized by a strap so it can't be moved, their hands are cuffed to the chair and the legs are shackled. they ask, 'are you going to eat or not?' and if not, they insert the tube. people have been urinating and defecating on themselves in these feedings and vomiting and bleeding. they ask to be allowed to go to the bathroom, but they will not let them go. they have sometimes put diapers on them. 193 professionals 201 (ryan goodman & mindy jane roseman eds., 2009); hernan reyes, medical and ethical aspects of hunger strikes in custody and the issue of torture, international committee of the red cross (1998). 192 see, e.g., eric schmitt & tim golden, force-feeding at guantdnamo is now acknowledged, n.y. times (feb. 22, 2006); dr. william winkenwerder, assistant secretary of defense for health affairs, media roundtable with assistant secretary winkenwerder, u.s. dep't of def. (june 7, 2006), available at http://www.defense.gov/transcripts/transcript.aspx?transcriptld=33 [hereinafter winkenwerder, media roundtable] (acknowledging forced feeding is "a medical recommendation from a physician, and it's a command decision"); george annas, hunger strikes at guantanamomedical ethics and human rights in a "legal black hole," 355 new eng. j. med. 1377 (2006); and allen & reyes, supra note 191, at 201; reyes, supra note 191. 193 see, e.g., eric schmitt and tim golden, force-feeding at guantinamo is now acknowledged, n.y. times (feb. 22, 2006) (quoting detainee emad hassan). 196 vol. 11:1 legal but unethical while the broader question of the propriety of forced feeding is important, of relevance to this article is whether forced feeding is administered for the purpose of furthering interrogation. as with the medical care discussed in the immediately preceding section, the motivation behind forced feeding is unclear. dod officials generally have argued forced feeding at guantanamo was premised on respect for "life."19 4 perhaps more candid assessment would reveal the pentagon's concern for the international public relations difficulties posed by dying detainees. however, little evidence has been produced demonstrating detainees have been force fed so they could undergo interrogation. a. law international law is generally silent on forced feeding of prisoners. domestically, courts have generally permitted forced feeding where the forced feeding is performed by a physician in accordance with good and accepted medical procedures and the prisoner is either suicidal or the treatment refusal presents a considerable security problem for the entire prison. 195 this reflects a preference for the values of preservation of life common in western countries. 196 dodi 2310.08e acknowledges involuntary treatment might occur, stating it should be preceded by "a thorough medical and mental health evaluation of the detainee and counseling concerning the risks of refusing treatment" and that any treatment should be "carried out in a medically appropriate manner."197 these instructions would seem to rule out the use of emergency restraint chairs, but 194 see, e.g., winkenwerder, media roundtable, supra note 192 ("we have a policy that is to preserve life. that policy is an ethical policy. it's in the best interests of the individual who is a hunger striker, for his life to be preserved, in our judgment."). 195 see, e.g., washington v. harper, 494 u.s. 210, 227 (1990); singletary v. costello, 665 so. 2d 1099 (fla. dist. ct. app. 1996); thor v. superior court, 855 p.2d 375, 385 (cal. 1993); comm'r of corr. v. myers, 399 n.e. 2d 452, 458 (mass. 1979). 196 allen & reyes, supra note 191, at 201. 197 dodi 2310.08e, supra note 2, at para. 4.7.2. 2014 197 indiana health law review nonetheless continue to permit force-feeding of mentally competent prisoners.198 however, this legal preference for preservation of life is contrary to professional ethical standards. as previously noted, the declaration of tokyo prohibits physicians from using their knowledge to facilitate interrogation and explicitly states, "where a prisoner refuses nourishment and is considered by the physician as capable of forming an unimpaired and rational judgment concerning the consequences of such a voluntary refusal of nourishment, he or she shall not be fed artificially."199 further, the wma's declaration of malta, also revised in 2006, perhaps to address activities guantanamo, states that "[h]unger strikers should not be forcibly given treatment they refuse. forced feeding contrary to an informed and voluntary refusal is unjustifiable." 200 thus, forced feeding by mhps at guantanamo, while not illegal (and in fact authorized by dod policy and ordered by military commanders), is directly contrary to ethical standards.201 198 see annas, supra note 191. 199 revised declaration of tokyo, supra note 27, at para. 6. 200 wma declaration of malta on hunger strikers, world med. ass'n, http://www.wma.net/en/30publications/1opolicies/h31/ (last visited dec. 26, 2013). 201 dr. william winkenwerder, then assistant secretary of defense for health affairs, admitted as much when saying in 2006, "[as for hunger strikes, w]e view what we are doing as largely consistent with that [malta] declaration." winkenwerder, media roundtable, supra note 192. indeed, "largely consistent" means that there must be parts that are inconsistent. 198 vol. 11:1 legal but unethical 6. examples: sharing medical information with interrogation teams despite contradictory statements by senior united states officials, it is clear information from detainee medical records was shared with interrogation teams. 202 in fact, dr. david tornberg, then-deputy assistant secretary of defense for health affairs, admitted to-and defendedsharing clinical medical information with interrogators, and he arguing that they "could not conduct their job without that info."203 the policy of the combatant command with geographic responsibility for guantanamo explicitly required medical care teams at guantanamo to share "any information concerning the . . . national security mission" to nonmedical personnel. 204 sometimes this information sharing involved the health provider directly revealing information to interrogators or 202 in one example, "interrogators were told that a detainee's medical files showed he had a severe phobia of the dark and suggested ways in which that could be manipulated to induce him to cooperate." lewis, interrogators cite doctors'aid, supra note 110. other detainees believed what they had told their psychological providers in a patientprovider setting had been shared with interrogators, based on the nature of subsequent interrogations. hashemian et al., supra note 6, at 86. senior united states officials have made contradictory statements regarding whether, and the extent to which, detainee medical records were shared with interrogators. slevin & stephens, supra note 3, at al. brigadier general rick baccus, who commanded guantanamo from march 2002 to october 2002, said new detainees' records were routinely shared with military intelligence personnel and military doctors and medics were available to advise interrogators about the new detainees' health. however, brigadier general baccus's successor, major general geoffrey miller, insisted otherwise, denying a claim by the icrc based on detainee complaints that medical records were being shared with interrogators for the purpose of developing interrogation plans. id. 203 bloche & marks, doctors go to war, supra note 10, at 4. dr. tornberg further noted that clinicians made detainees aware there was limited or no doctor-patient confidentiality, a claim that has not been verified. id. 204 r.a. huck, chief of staff, u.s. southern command, policy memorandum 8-02 (aug. 6, 2002), available at http://wwwl.umn.edulhumanrts/oathbetrayed/huck%208-2-02.pdf. 2014 199 indiana health law review bsct members. 205 in other instances, interrogation teams were given access to the medical records, sometimes without the knowledge or assent of the providers and sometimes over their express objection. 206 this information was used to develop interrogation plans and may have been used to "[c]lear prisoners for harsh interrogation." 207 for hps familiar with extraordinarily limited medical information sharing under united states patient privacy laws, such as the health insurance portability and accountability act 208 ("hipaa"), providing health information to individuals not part of the medical care team would be extraordinarily abnormal. for such providers, sharing information with other hps-the psychiatrists and psychologists of the bscts-rather than interrogators, would likely be easier. however, from a legal and ethical privacy standpoint, these bsct personnel were no different than laymen-they were not part of the medical treatment team. bsct personnel routinely reviewed detainees' medical information at guantanamo, having direct access to detainee medical records through at least june 2004.209 clinical personnel at guantanamo also made detainee records available to intelligence staff and met with bsct personnel "to provide information about prisoners' mental health and vulnerabilities." 210 205 lewis, interrogators cite doctors'aid, supra note 110. 206 as noted above, the new york times received a specific report from one investigator that a bsct member reviewed a detainee's file and specifically recommended exploiting the detainee's longing for his mother. id. 207 miles, supra note 3, at 55. according to one civilian psychiatrist who visited guantanamo as part of a monitoring team, detainees' medical records included "names, nationalities, and histories of physical and psychological problems, as well as notes about current complaints and prescriptions" and "psychologists' comments about conditions such as phobias, as well as family details, including the names and ages of a spouse or children." slevin & stephens, supra note 3, at al. such information would clearly be valuable to interrogators intending to exploit it for the purpose of causing detainee compliance. 208 health insurance portability and accounting act of 1996, pub. l. no. 104-191, 110 stat. 1936 (1996). 209 army surgeon general assessment, supra note 55, at 18-13. 210 slevin & stephens, supra note 3, at al. 200 vol. 11:1 legal but unethical a. law contrary to one commentator's assertion that sharing medical information with interrogators would be a "clearcut violation of the geneva conventions," no international law prohibits--clearly or otherwise-sharing personal health information under these circumstances. 211 also, contrary to popular assumption, perhaps understandable because of rigorous health privacy laws in the united states like hipaa, 212 there is no international or domestic law providing for absolute confidentiality of non-united states citizen detainees' medical records. dodi 2810.08e correctly recognizes this legal reality, stating that "[ulnder u.s. and international law and applicable medical practice standards, there is no absolute confidentiality of medical information for any person. detainees shall not be given cause to have incorrect expectations of privacy or confidentiality regarding their medical records and communications." 2 13 in fact, dodi 2810.08e specifically authorizes the sharing of patient-specific medical information for "national security-related activity."214 b. ethics in contrast to the relative absence of law constraining the sharing of detainees' personal health information with interrogators, and the dod regulation specifically authorizing it, ethical standards explicitly limit such sharing. the w1via's declaration of tokyo prohibits physicians from using "health information specific to individuals" to facilitate or otherwise aid any interrogation. 2 15 thus, under this rule, even if a physician told a detainee his information would be shared with 211 id. ("steven h. miles, a professor of bioethics at the university of minnesota, said that using the information in interrogations of detainees would be a 'clear-cut violation' of the geneva conventions."). 212 health insurance portability and accounting act of 1996, pub. l. no. 104-191, 110 stat. 1936 (1996). 213 dodi 2310.08e, supra note 2, at para. 4.4. 214 id. 215 revised declaration of tokyo, supra note 27. 2014 201 indiana health law review interrogators, thereby fulfilling his obligation under dodi 2610.08e to not mislead the detainees, the subsequent sharing of that information would be prohibited. the american psychiatric association also flatly prohibits sharing information: "[p]sychiatrists should not disclose any part of the medical records . . . to persons conducting interrogation of the detainee." by contrast, the ama's opinion 2.068(1) provides that physicians must "inform detainees of the extent to which interrogators may have access to the detainee's medical records." complicating the application of these rules to military physicians and psychiatrists is the fact that they do not have exclusive control of the records. medical records are the property of the united states, not the individual providers. thus, while they could fulfill their obligations to not disclose medical records themselves, they would be unable to prevent the united states from disclosing the information to interrogators. apart from the usual prohibition on engaging in, tolerating, directing, supporting, advising, or offering training in torture, or cruel, inhuman, or degrading treatment, the apa is silent regarding information sharing. ostensibly, information sharing in the interrogation context is permissible, except where torture, cruel, inhuman, or degrading treatment, is involved. this is important, because bscts are now primarily comprised of psychologists. thus, the dod regulation provides a negative obligation (not to misinform detainees), the ama imposes an affirmative obligation (to inform detainees of how information will be used), and the wma and american psychiatric association flatly prohibits information sharing. this is an area where professional associations' efforts to curb a particular activity appear to have failed. d. conclusion law does not proscribe mhps from planning general interrogation, providing interrogation training, planning specific interrogations, consulting with interrogators during vol. 11:1202 legal but unethical interrogations, evaluating or monitoring a detainee's health before, during, or after interrogation, providing medical care that incidentally allows interrogation to continue, including forced feeding, or sharing detainee medical information with interrogators. of the remaining activities that do constitute per se violations of law, such as failure to report abuse, concealing evidence of criminal activity, withholding medical care in exchange for cooperation, and performing nonconsensual experiments, law no more constrains hps than it does any other service member and the facts do no support allegations that mhps engaged in such activity. by significant contrast, nearly all the criticized activities do potentially violate professional ethical standards, including providing general interrogation planning assistance and training, planning specific interrogations, consulting with interrogators during interrogations, evaluating or monitoring a detainee's health before, during, or after interrogation, providing medical care that allows interrogation to continue, sharing detainee medical information with interrogators, failure to report abuse, withholding medical care in exchange for cooperation, participating in forced feeding, and conducting nonconsensual medical experiments. iv. conclusion: the impact of the law-ethics divide as demonstrated above, there is a significant divide between what the law proscribes and international and domestic professional ethical standards require regarding mhps' interrogation-related activities. indeed, "medical ethics as articulated by the wma are often in conflict with national laws . .. ."216 many legal activities are deemed unethical and health professionals are prohibited from participating. but so what? why does it matter that professional ethics stand alone in empowering hps as guardians of human rights and constraining their hps' interrogationrelated activities? the negative consequences of the status 216 allen & reyes, supra note 191, at 191. 2014 203 indiana health law review quo demonstrate its unacceptability. first, professional ethics alone fail in their effort to empower hps as guardians of human rights and constrain their hps' interrogationrelated activities. second, the law-ethics divide cedes too much policy control over national security issues to nongovernmental professional organizations. third, based upon the current trajectory, there is a risk that professional ethics will completely eliminate hps from all aspects of interrogation, which could have disastrous consequences. finally, the law-ethics divide harms individual hps. though dod has, for now, implemented regulations addressing some of the professional ethics issues, the law generally constrains hps no more than it does other service members. mhps may be proper protectors of human rights in the context of interrogation, but the la w does not create or demand that special role. those hoping hps might serve as superior protectors against interrogation abuses-or those wishing to criticize hps' failure to so serve-must rely on professional ethics to accomplish what law has not, a reality demonstrated by the number of vocal efforts to use international and domestic professional associations, state licensing boards, and even state legislatures to accomplish these purposes. if establishing hps as special guardians in the context of interrogations is desirable, we must ask whether this reality-where professional ethics specifically empower and constrain hps' interrogation-related activities while law does not-is prudent or adequate. the potentially deleterious effects on national security and individual providers suggest it is not. a. the law-ethics gap leaves mhps unempowered to protect detainees as one commentator has observed, "[j]ust when the nation most needed to draw on these professionals' specialized expertise to limit or counterbalance military excess, a significant number of these professionals failed to 204 vol. 11:1 legal but unethical act in accordance with their professional code of conduct." 2 17 simply stated, professional ethics alone failed to empower hps to prevent interrogation-related detainee abuse and, as a consequence, the strategic harm to the united states due to the reputational impact of abuses and the recruiting tool such abuses provided terrorist groups. it is far beyond the scope of this discussion to analyze the national, institutional, cultural, and individual failures that led to the united states abusing detainees it interrogated. however, regarding the facet of that failure discussed in this article, if, as i argue, la w did not address most hps' interrogation-related activities, critics must acknowledge professional ethics alone also failed to constrain such activities. admittedly, professional associations' first significant specific responses to alleged interrogation-related abuses in the gwot came in 2006, over four years after hps' involvement in interrogation began. thus, some may argue tightened professional ethics have since succeeded in curbing interrogation abuses. whether it was professional ethics or the nation's legal response in the form of the dta that curbed the underlying detainee abuses, professional ethics constrain hps in a way law does not. further, commentators continue to argue dod policy is inconsistent with ethical obligations. indeed, the continued arrival in these later years of books, articles, and symposia on the subject of hps' involvement in interrogation-related activities suggests the issue is not resolved. 218 217 cassandra burke robertson, organizational management of conflicting professional identities, 43 case w. res. j. int'l l. 603, 604 (2011) (referring to health, legal, and religious professionals). 218 see, e.g., jonathan marks & m. gregg bloche, the ethics of interrogation-the us. military's ongoing use of psychiatrists, 359 new eng. j. med. 1090, 1091 (2008) (arguing that though "[dod should be credited for requiring behavioral science consultants not to 'perform any duties they believe are illegal, immoral or unethical,' the value of such a mandate is undermined by the confusion [dod policy] introduces regarding the ethical obligations of health professionals who serve as consultants" and "[dod's policy] seeks to undermine the positions taken by the ama and apa concerning physicians' monitoring of interrogations."). recent articles include brennan, torture of detainees, supra note 3; george j. annas, american vertigo. 'dual 2014 205 indiana health law review reminded by justice brennan that "[alfter each perceived security crisis . . . the united states has remorsefully realized the abrogation of civil liberties was unnecessary [but] has proven unable to prevent itself from repeating the error when the next crisis came along," we must look toward the next moment where we hope mhps will serve as guardians of human rights and ask whether they are sufficiently empowered to do so. 219 so long as that role is established by professional ethics alone, without the corresponding backing of law, they are not. while the failure of professional ethics alone to produce the guardians of human rights hps' promoters envision may be attributed to a variety of causes, two inherent institutional limitations of health professional ethical standards to constrain hps in the military context. 1. military medical community is subordinate to operational actors first, the medical community is culturally subordinate to the "operational" community in the military. at both the operational "field" level and senior policy level, hps carry influence, but not final decision-making authority, and many commentators simply overestimate the medical community's ability to influence key decision-makers regarding interrogation techniques. one frequent commentator's assessment summarized this view: we must educate, mentor and empower [health professionals in the military and intelligence agencies] to be guardians of human rights and to say no to any practice or environment that violates these fundamental use," prison physicians, research, and guantinano, 43 case w. res. j. int'l l. 631, 649 (2011); miles, supra note 3; interrogations, forced feedings, and the role of health professionals, (ryan goodman & mindy jane roseman eds.) (2009). 219 william j. brennan, jr., the quest to develop a jurisprudence of civi liberties in times of security crises, 18 isr. y.b. hum. rts. 11 (1988). indeed, the future is no place to place our better days. vol. 11:1206 legal but unethical norms. if we fail to do this, we will do a great disservice to them, to those they harm (or, at the very least, fail to protect), andultimately-to ourselves. 220 while hps should serve as guardians of human rights, anyone who deduces that "education, mentorship, and empowerment" offered by professional ethics alone can establish and empower hps to become such guardians of human rights and to "just say no" is mistaken. the idea that education, mentorship, and empowerment can create rank-and-file guardians of rights vastly overestimates the ability of lower-ranking mhps "in the field" to influence decision-makers. the leader of the bsct tasked with creating the bsct counter-resistance strategy memorandum-that is, the senior health professional advising the interrogators at guantanamo-was a major (a mid-level commissioned officer), while the commander driving the use of enhanced interrogation techniques was a two-star general, who was himself being pressed for actionable intelligence by four-star generals and cabinetlevel presidential appointees. that health professional's relative power vis-a-vis the commanding general was miniscule, both because of rank discrepancy and because of the cultural role to which medical personnel can be relegated in operational decision-making. 22 1 professional ethics has a minimal impact on operational ("field") commanders' decisions. for good or ill, united states military commanders are more concerned with whether an action is legal or illegal than whether it comports with a particular professional's ethical standards. a commander would likely follow the advice of her legal advisor who 220 marks, looking back, supra note 10, at 47. 221 see marks, looking back, supra note 10, at 30 (noting mhps are often perceived as "not real soldiers"). this is not a universal problem. many commanders value the input of their health, legal, and spiritual professional advisors. unfortunately, as a cultural matter many do not, and merely hoping they will is an unreliable method of ensuring policy influence. additionally, though the input of mhps is very important when the health of united states service members is at issue, that is not always the case when the health of others is at issue. 2014 207 indiana health law review unequivocally states a particular action is illegal, yet be unlikely to follow the dictates of one of her subordinate's professional ethics. this disparity makes some sense-the commander has a personal stake in not violating the law and has no such interest in following the ethical tenets of a profession of which she is not a part. an individual health professional just "saying no" would at most result in that health professional's removal from the interrogation environment ultimately leading to installation of someone who would say "yes" or to the complete absence of hps in the interrogation environment. and as discussed below, removal of hps from the interrogation environment will not prevent abuses from occurring. moreover, as the guantanamo example clearly demonstrates, while policy decisions with national security implications may be influenced by mid-level officers in the field (for example, the bsct major psychologist and the lieutenant colonel staff judge advocate who respectively created and blessed the enhanced interrogation techniques), they are ultimately made at the highest levels of united states government, sometimes directly contrary to the most experienced and knowledgeable advisors' opinions. 222 no amount of "education, mentoring, and empowerment" for the major would have put him in a position to alter the department of defense's decision to use harsh interrogation techniques. the gravitational pull of hps at the senior policy-making levels of the dod waxes and wanes, resulting in high and low tides of deference to professional ethics. whether professional medical and psychological ethics have significant influence on policymaking, as may be the case now, or play little role in the formulation of national security strategy, depends on the personalities and agendas 222 for example, the opinions of senior uniformed attorneys regarding acceptable interrogation techniques were disregarded by the bush administration. see, e.g., william fisher, early warnings on prisoner abuse ignored, inter press service, aug. 4, 2005 (demonstrating the judge advocates general's concerns about harsh interrogation techniques were ignored by defense department political appointees), available at http://www.commondreams.org/headlines05/ 0804-07.htm (last visited dec. 26, 2013). 208 vol. 11: 1 legal but unethical of the senior policymakers in a given administration. even if one accepts that dod's current policy and regulations affecting hps' involvement in interrogation demonstrate a respect for the professional ethics of its individual hps (a position not all accept), such views can be transitory. for example, in 2004, then-deputy assistant secretary of defense for health affairs dr. david tornberg suggested medical ethical rules are inapplicable when a physician is assisting interrogators because, in his view, a medical degree is not a "sacramental vow," but rather is a certification of skill, and, therefore, when a doctor participates in interrogation, "he's not functioning as a physician," and the hippocratic ethic of commitment to patient welfare does not apply. 223 2. professional dual loyalty second, the idea that professional ethics can sufficiently establish mhps as guardians of human rights does not sufficiently account for the problem of professional dual loyalty of mhps. whether or not current dod policy is consistent with professional ethical standards, mhps may again be forced to choose between their loyalties to the military and their health profession. the problem of "dual loyalty" is present whenever a professional is obligated by more than one set of professional principles. whenever hps-even those not in military service-are involved in activities other than direct treatment of patients, questions of conflicting professional obligations arise. 224 as professor marks and dr. bloche have noted: 223 m.g. bloche & j.h. marks, doctors go to war, supra note 10, at 4. according to dr. tornberg's view, as long as the military maintains a separation of roles between clinical caregivers and physicians with intelligence-gathering responsibilities, assisting interrogators is legitimate. id. 224 even outside the military context, hps may have obligations to others than just their patients, including family members, employers, insurance companies, and governments, all of which may conflict with undivided devotion to the patient. see leslie london et al., dual 2014 209 indiana health law review military physicians point to civilian parallels, including forensic psychiatry and occupational health, in arguing that the medical profession sometimes serves purposes at odds with patient welfare. they argue, persuasively in our view, that the hippocratic ideal of undivided loyalty to patients fails to capture the breadth of the profession's social role. this role encompasses the legitimate needs of the criminal and civil justice systems, employers' concerns about workers' fitness for duty, allocation of limited medical resources, and protection of the public's health.225 as demonstrated, mhps' legal obligation to their military service can conflict with their ethical obligation to their health profession, with each "obligor" stating their obligations trump the others'.226 the dual loyalty problem faced by mhps is demonstrated by calls for primacy from each of the objects of that loyalty. mhps are simultaneously told they should be a "physician first and a military officer second" 227 and loyalty among mhps: human rights and ethics in times of armed conflict, 15 cambridge q. healthcare ethics 381, 382 (2006). 225 bloche & marks, doctors go to war, supra note 10, at 4. 226 compare american psychological association amends ethics code to address potential conflicts among professional ethics, legal authority and organizational demands, am. psychol. ass'n (february 24, 2010), http://www.apa.org/news/press/releases/2010/02/ethics-code. aspx (stating members cannot adhere to the law or demands of an organization if doing so would require violating the code of ethics) with e.g. howe, mixed agency in military medicine: ethical roles in conflict, 1 mil. med. ethics 331, 335 (2003) (arguing in certain scenarios it is justifiable for military medical providers to elevate the military role above the medical); carter w. madden, physician -soldier: a moral profession, 1 mil. med. ethics 269, 282 (2003) (arguing in wartime the physician-soldier "is not violating his professional responsibility to relieve pain and suffering; rather it is being met in a special way.") 227 see, e.g., annas, supra note 191, at 1379 ("force-feeding at guantanamo and the hamdan opinion provide the opportunity for the u.s. military to adopt as formal military doctrine the rule that a 210 vol. 11:1 legal but unethical "[ylou are first and foremost soldiers, and only after that, doctors." 228 the contrast between ethical standards' relatively tight restrictions and the law's relative silence regarding interrogation-related activities by hps amplifies the dual loyalty problems already faced by mhps. as multiple commentators have acknowledged, even those generally critical of military health professional involvement in interrogation, individual hps cannot resolve the competing obligations by themselves. 229 indeed, "we would affirm [military healthcare professionals'] honor, not besmirch it, by acknowledging the tensions between their hippocratic and national service commitments and by working with them to map a course between the two."2 30 not surprisingly, many health ethicists argue that whenever dual loyalty is encountered, loyalty to the health profession should prevail. 231 but this seems an overly simplistic response to a complex problem, especially when national security interests are at stake. while law may never keep pace with changes to ethical standards, where national security interests are at issue, the law should resolve the dual loyalty, rather than leaving it to insufficiently empowered hps to do so. this problem of dual loyalty, not unique to hps in the military, 232 may be endemic to professionals' military service and not completely remediable, meaning law that resolves the pull of the individual's dual professions is all the more important. moreover, as important scholarship in identity theory and dual loyalty has articulated, even where physician in the military is always a physician first and a military officer second") (emphasis added). 228 see, e.g., ugur cilasun, torture and the participation of doctors, 17 j. of med. ethics s21-22. (supp. 1991). 229 rubenstein, supra note 7. 230 bloche & marks, doctors go to war, supra note 10, at 6. 231 see, e.g., annas, american vertigo, supra note 218, at 649 (arguing that "the only 'solution' to it is for prison physicians to refuse to comply with any order or request from prison officials, including military commanders in charge of military prisons, that is inconsistent with medical ethics"). 232 see, e.g., robertson, supra note 217, at 613-14 (providing examples of dual loyalty challenges faced by military lawyers and military chaplains). 2112014 indiana health law review the military does not demand a health professional violate or abandon his or her professional ethics, hps "unconsciously avoid or overlook them."2 33 here again, law may be at least a partial answer, as it is more difficult to avoid or overlook law. while military leaders at all levels would wisely seek to harmonize professional ethics and institutional objectives, and may currently do so, when the next crisis comes, hps and the nation would be better off with law that resolves dual loyalty issues rather than exacerbates them. b. the law-ethics gap cedes too much power to professional health associations the status quo of the law-ethics divide cedes too much policy control over national security issues to nongovernmental professional organizations. no argument is necessary that the interrogation of detainees and, by extension, hps' role therein, has strategic national security implications. with so much at stake, how is it appropriate to bestow upon professional organizations authority to dictate what specific military members may and may not do? consider the following hypothetical: a military commander directs a military health professional to assist in a particular task that is vital to national security. the task is irrefutably legal, but constitutes a violation of an international professional association's opinion regarding professional ethics. is the right answer for the government to throw up its hands and defer to the unelected international professional association? many health profession ethicists-and perhaps hps-would likely welcome this development. but is that an appropriate outcome for a democratic nation ostensibly governed by the rule of law? the value of professional organizations as a conscience for their professions and society at large is irrefutable. professional associations like the w1via and a1via establish 233 id. at 615. 212 vol. 11: 1 legal but unethical extraordinarily helpful worldwide and domestic guidelines that prevent needless suffering. but these organizations are not elected governments nor are they treaty bodies granted authority by sovereign states. ceding such policy decisions to non-governmental organizations is antithetical to democratic principles. some object that "giving legal norms the last word on the limits of professional conduct leaves psychiatrists and psychologists without clear guidance in the face of disagreements between lawyers and policymakers about the application of those norms."2 34 unfortunately, so too does giving malleable ethical standards the last word. thus, the question is what body should have the "last word" in these matters? international law, domestic law, or ethical standards as articulated by any number of international and domestic professional organizations? while this may seem a tired debate, the conflict between law and ethics in the context of hps' interrogation-related activities demonstrates the issue is not anachronous. of course, the department of defense should not have sole authority to dictate what mhps must or may do. 2 35 that is why, when matters with such import to national security are involved, society, through its democratic government, should determine the balance between national security, human rights, and freedoms. if there are specific activities society wants to prevent hps from engaging in, they should be proscribed by law. likewise, if we choose to allow hps to engage in activities, we should empower and protect them by law. while one would hope society would take its cues from the human rightsprotecting professional associations, in a democratic system, the views of unelected and non-representative professional 234 marks, doctors as pawns., supra note 10, at 724 (noting that "efforts to redefine the scope and meaning of the geneva conventions and the prohibition of cid treatment in core human rights treatiesdiscussed above-provide two powerful illustrations of this point."). 235 see, e.g., marks, looking back, supra note 10, at 43 ("when professional organizations issue ethical statements after due deliberation and consultation, and those statements prohibit health professionals from acting in certain ways, the military should respect these statements."). 2014 213 indiana health law review associations should not trump, as is arguably the present case with hps' interrogation-related activities. c. the law-ethics gap may exclude health professionals from interrogation process the current trajectory of more and more restrictive ethical standards pronounced by professional organizations raises the increased possibility hps could be removed from the interrogation process altogether, either by increasingly restrictive ethical standards or by the choice of mhps who decide not to subject themselves to the tension between military duty and professional ethics created by the lawethics divide. indeed, several commentators have suggested that hps should, if unable to influence the course of interrogation techniques used, withdraw from the interrogation environment altogether. 2 36 some ethicists take the next step, objecting to hps' involvement with interrogation altogether, no matter how tame. 237 indeed, ethical standards such as the declaration of tokyo as revised in 2006, prohibit hps' participation in interrogation, regardless of its nature.238 this position raises numerous policy questions about the benefits and risks of health professional participation that are best decided by an informed representative government, not a domestic or international professions association. for 236 for example, two commentators argued "effective prevention of complicity in torture may simply require the withdrawal of health professionals from the interrogation setting" and that the presence of medical personnel in interrogation settings "does not represent an effective systemic check on the abuse of detainees." see brewer & arrigo, supra note 7, at 5, 19 (arguing that "effective prevention of complicity in torture may simply require the withdrawal of health professionals from the interrogation setting" and that the presence of medical personnel in interrogation settings "does not represent an effective systemic check on the abuse of detainees"). 237 see, e.g., edmund howe, further considerations regarding interrogations and forced feeding, in forced feedings, and the role of health professionals 85 (ryan goodman & mindy jane roseman eds. 2009). 238 revised declaration of tokyo, supra note 27. 214 vol. 11:1 legal but unethical example, can it really be the case that we would not want a doctor or psychologist to check on a detainee's medical status after questioning? if our only "interrogation method" were calm questioning for four hours at a time, why would it be unethical for a medical professional to do a quick postinterrogation assessment of the detainee to make sure they were okay? is the only distinction what actually occurs in the interrogation room? if so, how does it make sense to allow medical professionals to evaluate the health of a detainee who has not been interrogated "harshly," while not permitting such an evaluation of detainees who were harshly treated (i.e., those for whom the evaluation is more important)? is the real distinction about the ethics here what the medical provider's purpose for evaluating the patient? if it is to determine that the detainee is healthy, it is fine; if it is to further the next round of harsh interrogations, it is not? or is the real distinction really the underlying activity of the interrogators, over whom the hps have no control? a system where hps are completely uninvolved in providing advice regarding the suitability of interrogation procedures generally or regarding specific activities in light of a particular detainee's health is arguably imprudent for several reasons. first, it suggests the fundamental evil to be prevented is hps' "complicity in torture," rather than the underlying torture itself. second, such a policy would effectively require lay people to determine whether certain interrogation activities will result in long-term harm. some may over-optimistically hope that removal of the hp from the interrogation process would mean the end of the interrogation, but this is most unlikely. because long-term harm is a legal element of whether something constitutes torture, removing hps from the process would increase the likelihood of criminal acts being committed by interrogators. more importantly, it would increase the likelihood detainees would be harmed by interrogators ignorant of the medical or mental health consequences of their actions. further, as allegations discussed in this article demonstrate, assuming we want hps involved in ensuring detainee health generally (apart from interrogation), it is difficult to exclude such 2014 215 indiana health law review professionals completely from "interrogation-related activities."2 39 the possible withdrawal of hps from the interrogation environment is not only precipitated by professional associations' direct and increasingly restrictive ethical standards, but also the tension created by the widening lawethics divide between obeying legal military orders and complying with professional ethical obligations. the very real burden this imposes on mhps, discussed in detail in the next section, may simply cause mhps to decide to practice medicine and mental health care elsewhere, causing a new difficulty for the military. d. the la w-ethics divide harms mhps contrary to some of the heated rhetoric in the debate over their involvement in interrogation-related activities, mhps are, as a whole, an extraordinarily selfless group of highly skilled professionals who spend each day satisfying the dual noble goals of serving their country and humanity. it is these hps who are most acutely aware of the divide between law and ethics because of the professional and personal risks that divide imposes. the impact on individual mhps of these interrogation-related activities is immense and the professional and personal risks and interests of the individual providers in these ethical and legal questions have been insufficiently examined and protected. not only are hps faced with making choices between competing claims for their loyalty, as discussed above, they must make such choices while risking personal 239 indeed, some critics have gone so far as to blame hps for abuses simply because the health professional happened to be simultaneously assigned to the detention facility where the abuses occurred. see, e.g., stephen soldz et al., an open letter to sharon brehm, president of the american psychological association (june 7, 2007), available at http://www.counterpunch.org/2007/06/07/on-psychologists-and-torture/ (asserting that "james was the commander of the bscts at the time the fbi and other law enforcement agents were reporting that severe abuses were occurring at guantinamo," implying colonel james was responsible for the abuses). 216 vol. 11:1 legal but unethical consequences created by the divide between law and professional ethics. 1. professional risks a. health professional risks dod's position that professional ethics do not apply to hps not engaged in clinical practice is controversial and further exacerbates the difficulty for mhps called upon to act in non-clinical roles in a way that contravenes professional ethics. 240 the potential impacts on a health professional's medical or psychology career need little amplification after reviewing the various ethical pronouncements of the professional associations discussed in this article. while there have thus far been no reported cases of state licensing boards actually disciplining mhps for their interrogation-related activities, investigations have occurred, and the fear of such action is real for the hps who have already engaged in interrogation-related activities and for those who might consider doing so in the future. additionally, the nationally publicized professional disapprobation a health professional could receive from one's professional colleagues-such as that demonstrated by the public identification of individual mhps involved in interrogations or the open letters written by the apa identifying individual military psychologists-can have real effects on employment and the financial prospects of one's private practice. 241 thus, while not "binding law," ethical standards can significantly influence hps' choices, with strong consequences possible for failing to obey ethical standards. 240 see london et al., supra note 224, at 385; bloche & marks, doctors go to war, supra note 10, at 3-6. 241 one website identifies lists specific providers alleged to have been involved in interrogation and encourages readers to "sign up to receive e-mail updates when additional health professionals are posted." when healers harm, center for constitutional rights, http://whenhealersharm.org/category/the-psychologists/. 2014 217 indiana health law review b. military professional risks on the other hand, the mhp who chooses to assert professional ethics above "the mission" faces significant military professional risks. in addition to the personal risk of ucmj action discussed below, there are obvious potential impacts on one's career in the military-like in most large organizations-when one is not considered a "team player." mhps have a personal career incentive to participate in whatever activities they have been ordered to participate in, regardless of possible ethical objections. 242 . after some military physicians refused to force-feed detainees, the dod began screening doctors to be assigned to guantanamo to ensure they would be willing to participate.243 while one hopes hps' good faith claims that such activities would violate their ethics will be respected by the dod, it is not at all difficult to envision difficulties with this approach. first, one wonders whether mhps interested in furthering their military careers would be comfortable self-selecting out of an opportunity to deploy in an operational environment. no doubt some would and others would not. a second problem arises if insufficient numbers of hps agree to participate in a particular questionable activity. then, dod will either forego the operational need (unlikely), or require participation by those who are uncomfortable. some may argue this is a hypothetical concern. experience has proven otherwise. risk to one's military career has personal impacts, too, including financial hardship. many hps enter the military in part because of enormous scholarships they receive to attend medical school or other expensive training, and leaving the military early, even if permitted to do so, could 242 see brewer & arrigo, supra note 7, at 15. though this article's point is well-founded, it cites as an example of how the military superior can exert control over the healthcare professional the outdated situations where military dissenters were compelled to undergo unnecessary and unwanted mental health examinations, a practice effectively banned by the military whistleblower protection act, 10 u.s.c. § 1034. 243 susan okie, glimpses of guantanamo-medical ethics and the war on terror, 353 new eng. j. med. 2529, 2530 (2006). 218 vol. 11-1 legal but unethical mean repaying six-figure sums to the government for failure to complete service obligations. some commentators argue that aside from the negative implications on one's military career, there is an inducement to go along with, rather than object to, interrogation activities: "wannabeism." 244 this theory suggests that because some mhps feel they are treated as inferior members who "aren't real soldiers," the allure of participating in or enabling interrogation is particularly strong, as it provides an opportunity to acquire "socially privileged status . . . and potential acceptance into the innermost sanctum of the intelligence community." 245 while perhaps overstated and not applicable to the majority of mhps, this is a legitimate concern for some. 2. personal risks a. criminal liability domestic criminal liability to which united states mhps might have been subject for interrogation-related activities was largely swept away by the statutory defense created by the dta.246 however, this defense was unavailable prior to enactment of the dta, meaning for over four years, mhps (like all others involved in interrogation) were potentially risking criminal prosecution for activities in which they were directed to engage. as noted in section iii, this liability was not just for direct acts of torture, in which hps 244 marks, looking back, supra note 10, at 30. 245 id. 246 national defense authorization act for fiscal year 2006, pub. l. no. 109-63, § 1404, 119 stat. 3136, 3475-76 (2006). the dta provided a legal defense exists to civil action or criminal prosecution for interrogation-related activities when the united states agent "did not know that the [interrogation] practices were unlawful and a person of ordinary sense and understanding would not know the practices were unlawful." a good faith reliance on the advice of counsel-ostensibly including government counsel such as olc-is specified to be "an important factor, among others, to consider in assessing whether a person of ordinary sense and understanding would have known the practices to be unlawful." 2014 219 indiana health law review were very likely not engaged, but also under various secondary liability theories, including accomplice liability and conspiracy. perhaps congress' main motivation in enacting the dta's statutory defense was to recognize this unfairness. for service members, potential criminal liability was not just a possibility for participating in interrogation-related activities, but also a possibility for not participating. under the ucmj, failure to obey a lawful order is a criminal offense. 247 thus, if a military health professional were to refuse to obey an order to participate in an interrogation in some way he believed violated his professional ethics, he could be charged and tried. while the prosecution in such a case would turn on the lawfulness of the order, that is small comfort to someone who would have to endure a criminal prosecution to determine whether his decision to disobey the order was justified. 248 moreover, as has been demonstrated, it is entirely possible an order could be lawful but unethical for the health professional. this reality is a powerful incentive to disregard professional ethics and a further demonstration of why professional ethical standards alone can be insufficient to constrain the behavior of service members. though primarily concerned with criminal prosecution in their own country, united states mhps, as with other united states personnel, may be justifiably concerned with whether other states will view their activities as "grave breaches" of the geneva conventions. other states may invoke universal jurisdiction to prosecute such war crimes, regardless of the united states' interpretation of the geneva conventions. 249 and as noted in section iii above, accomplice liability may rest on different legal standards in other jurisdictions. thus, even if hps are not concerned 247 10 u.s.c. § 892 (2013). 248 when the senior attorneys at dod and doj had opined such activities were lawful, it is easy to imagine an individual service member accused would have difficulty showing otherwise. 249 see jonathan h. marks, mending the web-: universal jurisdiction, humanitarian intervention and the abrogation of immunity by the security council, 42 colum. j. transnat'l l. 445 (2004). vol. 11:1220 legal but unethical about potential prosecution in the united states, they would be ill-advised to ignore that possibility while visiting another country. b. civiltort liability? tort liability for participation in interrogation-related activities-at least in the united states-is not a significant concern for mhps. 250 while ethical standards can sometimes be invoked to prove negligence or other breaches of standards of care in tort claims (another way in which ethical standards influence hps), the likelihood of tort claims against mhps reaching the merits is slim. in addition to government employees' usual defenses to individual civil liability for acts undertaken in one's official capacity under the westfall act,251 as noted above, the dta provided a defense available in civil or criminal cases for interrogation-related activities. 252 moreover, the mca made it impossible for anyone to invoke the geneva conventions in support of any claim in federal court. 25 3 e. conclusion not all commentators view the divide between ethics and law as problematic. in fact, some argue ethical standards serve the important function of filling a void created by malleable legal standards: "[w]hen legal protections for 250 indeed, the apparent lack of avenues for civil redress recently prompted a call for some type of financial accountability on the part of involved persons, including hps. brennan, torture ofdetainees, supra note 3. 251 the westfall act, 28 u.s.c. § 2679, was passed in 1988 as an amendment to the federal torts claim act to protect federal employees from personal liability for common law torts committed within the scope of their employment, allowing the united states to be substituted as a defendant in such suits. 252 national defense authorization act for fiscal year 2006, pub. l. no. 109-63, § 1404(a), 3475-76 (2006). this likely extinguished any possibility of claims under the torture victim protection act ("tvpa"), 28 u.s.c. § 1350, or the alien tort statute, 28 u.s.c. § 1350. 253 military commissions act of 2006, pub. l. no. 109-366, § 5, 120 stat. 2600 (2006). 2014 221 indiana health law review detainees are being undermined, it is all the more important that professional ethics (in particular, medical ethics) speak clearly and that codes of ethics do not become subordinate to, or dependent upon, unilateral reinterpretations of legal doctrine." 254 while a valid aspiration, unfortunately, professional ethical standards have proven to be as malleable as legal doctrine, as demonstrated by the american psychological association's multiple contrary pronouncements within a few years or the fact that a host of activities that were previously not "unethical" suddenly became so in 2006, once the wma, ama, and american psychiatric association altered their interrogation-related ethical standards to prohibit more than just direct torture. the appropriate response to the law-ethics divide seems not only to have professional ethics fill the cracks in the law, but for the cracks in the law to be narrowed. professional ethics are neither irrelevant nor unimportant; they play an essential role. additionally, we are reminded that "ethical codes should do more than reflect fundamental legal prohibitions." 255 while true, this suggestion is hortatory if hps are required to make unsupported choices when facing competing obligations. strong ethical standards can have the effect of changing attitudes and behavior. however, in the case of interrogation, if the goal is to elevate mhps as superior guardians of human rights, professional ethics have proven insufficient. but law is no panacea. history has demonstrated unclear law can be as malleable as ethical standards (e.g., the torture memos).256 however, this is not a persuasive 254 marks, doctors as pawns, supra note 10, at 713. 255 see, e.g., id. 256 indeed, some argue the legal implications of hps' activities relating to torture are not an important aspect of curbing torture because the legal restraints have been so malleable. marks, looking back, supra note 10, at 27 (arguing that the bush administration engaged in a "campaign of legal exceptionalism that sought to dispense with or render nugatory domestic and international legal norms that should have protected detainees from abuse," which increased the likelihood detainee abuse would occur). 222 vol. 11:1 legal but unethical argument against law per se, but rather against law that fails to clearly and sufficiently proscribe and prescribe behavior. indeed, as demonstrated in this article, evidence is slim that hps engaged in activities where law clearly proscribed behavior, such as with medical experiments, withholding care to obtain cooperation, and concealing evidence of abuse. this at least suggests clear law can work. perhaps the most troubling aspect of the invocation of the law by critics of mhps' interrogation-related activities is that it perpetuates the myth that the law actually addressed, and arguably thus constrained (or should have), hps' behavior or supported hps as protectors of detainee rights. this mistake allows reformers in search of solutions to point to law as a failure and cast it aside prematurely, arguing "[illlegality has not been decisive in the past to deter some advocates of aggressive techniques."257 rather than argue hps violated law or conflate law and ethics, those who wish to establish hps as guardians of human rights and defenders against torture and cruel, inhuman, and degrading treatment should argue the opposite. they should embrace the idea that international and domestic law has been insufficient to the task and that reliance on professional ethical norms alone is insufficient. only when persuasively demonstrated that current law is insufficient might the law change to more clearly support hps as guardians of human rights. in the meantime, professional ethics serve as a too-flexible and too-political tool for hps defending human rights in the interrogation context, both because their acceptance by decision makers is unpredictable and because they give too much authority to non-governmental actors. law leaves unresolved the question of whether mhps should engage in the types of interrogation-related activities frequently criticized, thus imperiling national security and individual hps. whether or not current law sufficiently proscribes the underlying conduct of torture, cruel, inhuman, or degrading treatment, experience in the gwot 257 marks, looking back, supra note 10, at 22. 2014 223 224 indiana health law review vol. 11:1 suggests professional ethical standards standing alone, without the corresponding support of law, are insufficient to establish hps as special guardians of human rights. the discussion of whether such professionals should serve in that capacity, and, if so, how that role should be recognized and supported, should not assume or imply the law already answers those questions. it does not. decline of mandatory physical education in grade schools resulted in the current childhood obesity crisis and consequently an unsustainable rise in health care spending, the the decline of mandatory physical education in grade schools resulted in the current childhood obesity crisis and consequently an unsustainable rise in health care spending frandy st. louis* i. introduction ............................ ........ 629 a. the issue ............................... ...... 631 ii. the success of federally mandated physical education following world war i..............633 iii. decline of mandatory physical education in public schools and the subsequent rise in childhood obesity through a changing landscape ... ..... 636 iv. proliferation of junk foods ................... 639 v. the real cost of obesity as reflected in increased health care spending .............................................. 640 a. the scope of the problem and its undeniable gravity .................................... ..... 641 vi. the current status of state laws and their documented failures support a federal mandate .................................. ........ 643 vii. a federal mandate will withstand a constitutional challenge. ..................... 650 viii. solutions to the problems of childhood obesity........................................ 658 a . p rincipal...................................................................... 658 b. alternative solution ................................................... 660 ix, conclusion. ............................ ........ 661 i. introduction the empirically-minded, father of the field of logic, and pioneer of greek philosophy, aristotle (writing in politics* j.d., indiana university robert h. mckinney school of law, 2013; b.a., georgia state university, 2010. indiana health law review 350 bce), recognized more than two thousand years ago that "education" (including physical education) is a function of the state.1 he further elaborated that education should be guided by legislation to make it correspond with the results of psychological analysis, and follow the gradual development of the physical and mental faculties of the individual.2 for aristotle education-both traditional and physical-was a proper matter to be legislated. given the pre-eminence of greek philosophy and politics in the development of our modern society and political democracy, the theoretical construct of legislating physical education through a federal mandate can be said to have its roots in established political principles. 3 this note will argue for a federal mandate requiring public schools to offer-as part of their curriculum-specific standards of physical education at all grade levels as a solution to the childhood obesity crisis and to reverse the long-running upward trend in healthcare related expenditures. but why is this question of physical education even relevant to the issue of childhood obesity and health care expenditures? after years of manifest neglect, the crisis of childhood obesity and the debate surrounding it have moved to the forefront of the nation's consciousness. 4 while this 1 charles hummel, aristotle (384-322 b.c.), 23 prospects 39 (1993), available at http://www.ibe.unesco.org/publications/thinkerspdf/ aristote.pdf ("no one can doubt that it is the legislator's very special duty to regulate the education of youth . . wle conclude, therefore, that education must be regulated by law, and that it must be controlled by the state."). 2 id. 3 wordology, rise of western culture & philosophy (classical greece), http://www.worldology.com/europe/europearticles/riseof_ westernculture.htm (last visited jan. 15, 2013) (declaring that "western thought and culture traces its roots to classical greece philosophy, which is based upon reason and inquiry pertaining to a variety of disciplines, including science, technology, literature, law, politics, economics, psychology, ethics, art, etc"). 4 don lemon, the debate over childhood obesity, cnn (feb.15, 2010, 11:20 am), http://newsroom.blogs.cnn.com/2010/02/15/the-debateover-childhood-obesity/ ("first lady michelle obama states that 1-in-3 american children is overweight; 1-in-2 among minorities. now she has launched let's move, a national program to get rid of junk food in public schools and educate children about proper diet and exercise. president 630 vol. 10:2 the decline of mandatory physical education crisis has become severe and pervasive, its cause is arguably well understood and there are steps that can and must be taken to confront it.5 a. the issue over the past few years, the majority of citizens and politicians alike have come to recognize that the nation is facing a childhood obesity crisis that is having an alarming impact on overall health and, as a consequence, an unsustainable rise in health care related expenditures.6 a recent study by the fortanasce-barton neurology center shows that children today are four to five times more likely to be obese (and as much as eight times more likely to be overweight) than in the 1960s and 70s.7 as a result of the rise in childhood obesity, the prevalence of preventable diseases (such as type ii diabetes, high blood pressure, certain heart conditions, and even premature death) among obama backed her up by establishing a federal task force to tackle the issue and come up with a plan of action in ninety days."). 5 thomas r. frieden et al., reducing childhood obesity through policy change: acting now to prevent obesity, 29 health aff. 357 (2010), available at http://www.banpac.org/pdfs/sfs/2010/reducchild obes_11_04_10.pdf ("childhood obesity is an epidemic in the united states, and is expected to increase the rates of many chronic diseases. increasing physical activity and improving nutrition are keys to obesity prevention and control. but changing individual behavior is difficult. a comprehensive, coordinated strategy is needed. policy interventions that make healthy dietary and activity choices easier are likely to achieve the greatest benefits. there is emerging evidence on how to address childhood obesity, but we must take action now to begin to reverse the epidemic."). 6 a. must et al., long-term morbidity and mortality of overweight adolescents (a follow-up of the harvard growth study of 1922 to 1935), 327 new eng. j. med. 1350 (1992), available at http://www.ncbi.nlm.nih.gov/pubmed/1406836; preventing chronic diseases: investing wisely in health, cdc, http://www.cdc.gov/ nccdphp/publications/factsheets/prevention/pdf/obesity.pdf (hereinafter preventing chronic diseases). 7 fortanasce-barton neurology center, a new year for a vital child, http://fortanasceclinic.com/a-new-year-for-a-vital-new-child.html (last visited jan. 15, 2013). 6312013 indiana health law review children has become all too common.8 given the magnitude of this crisis, it is important to explore its genesis in an attempt to first understand its anatomy, and ultimately adopt a plan that would provide a solution without undue delay.9 in exploring the childhood obesity crisis, it is important to understand that while its effects have already taken a tremendous toll on the nation, its making has been rather incremental and gradual.10 it is the unintended consequences of decisions that could plainly be said to have been shortsighted and improvident. 1 as a result of these decisions, the united states is now at a point in history where it faces an exigency that-if not swiftly, fully and comprehensibly dealt with-will continue to cause tremendous damages to the nation's social infrastructures. to address this crisis, it is critical that there be a national 8 a. must, supra note 6; preventing chronic diseases, supra note 6. 9 see victoria l. brescoll et al., the annals of the american academy of political and social science 178-79 (2008), available at http://ann.sagepub.com/content/615/1l178.full.pdf+html (emphasizing that "more than 17% of american children and adolescents are overweight or obese, with certain subgroups, such as african american youth, having even higher prevalence rates (18% to 26%), leading to increased incidences of hypertension, diabetes, and even heart attacks among obese children"). 10 jeffrey p. koplan et al., preventing childhood obesity: health in the balance, available at http://www.banpac.org/pdfs/sfs/ 2010/reduc childobes_11_04-10.pdf (discussing the toll already paid for the obesity crisis). 11 ted vilaire, decline of physical activity, http://prorev.com/ bigpage.htm (last visited jan. 30, 2013) (vilaire notes that "once customary for children at nearly every grade level, gym class has been steadily scaled back in recent years. just during the past decade, the number of u.s. high school students attending daily physical education classes dropped from 42% to 29%. according to the national association for sport and physical education (naspe), the nation's largest organization for physical education teachers, currently, nearly half of all students and 75% of high school students do not attend any physical education classes. judith young, executive director of naspe, maintains that schools cut gym classes for lack of funding, but more often cuts result from time constraints that develop with the addition of new curriculum. standards-based reform has been detrimental to physical education."). 632 vol. 10:2 the decline of mandatory physical education federal mandate requiring all public schools to incorporate specific minimum standards of physical education in their curriculum at all grade levels. to further elaborate on the imperative and need of a federal mandate requiring public schools to incorporate minimum standards of physical education in their curriculum, this note emphasizes solutions proposed by the american heart association task force on physical activity, and expands upon them for a more thorough approach. in order to facilitate a better understanding of the problem, and lay the groundwork for resolving it, section ii sets forth the general background of physical education through a historical perspective, and focuses on its effects on the nation's childhood obesity rate. section iii follows the decline of mandatory physical education and underlines the subsequent rise in the childhood obesity rate. section iv covers the proliferation of the junk food industry and its role in contributing to the problem. section v explains the rise in health care expenditures in relation to the rise in the childhood obesity rate. following this discussion, section vi introduces different state laws and analyzes their effects on the childhood obesity rate. section vii addresses potential constitutional challenges to a federal mandate designed to tackle the problem. and lastly, section viii proposes comprehensive solutions that should be adopted as part of a federal program mandating physical education at all grade levels for students attending public schools. ii. the success of federally mandated physical education following world war i according to lance c. dalleck and len kravitz, "in the united states, the early educational process [principally] focused on intellectual matters."12 "schools concentrated on teaching traditional subjects including reading, writing, 12 lance c. dalleck & len kravitz, history of physical education, http://www.unm.edulkravitzarticle%20folder/history.html (last visited mar. 9, 2013). 2013 633 indiana health law review arithmetic, and religious matters."13 "physical education remained missing from the public education system for the better part of the nineteenth century" until dr. j.c. warren-a medical professor at harvard university and strong proponent of physical activity-developed credible evidence that showed the proper functioning of the body and mind necessitated regular exercise.14 dalleck and kravitz noted that "[olne of the most important events [in the history of physical education] in the united states was the industrial revolution." advancement in industrial and mechanical technologies changed the way people lived and worked. 15 the cost of industrialization became conspicuously apparent in the mid-20th century as people started to develop-never before prevalent-diseases including, but not limited to, hypokinetic diseases, cardiovascular disease, cancer, and type ii diabetes.16 after world war i was fought and won, the federal government released statistics from the draft that revealed that one out of every three draftees "was unfit for combat and many of those drafted were highly unfit prior to military training." 7 to address the problem, "the government and many of the states passed legislation that ordered the improvement of physical education programs in 13 id. (explaining that "in the united states, the early educational process focused primarily on intellectual matters and was not concerned with physical education"). 14 id. 15 id. ("[aldvancement in industrial and mechanical technologies replaced labor-intensive jobs. rural life changed to an urban lifestyle. the new city life generally required less movement and work compared to rural life, consequently decreasing levels of physical activity."). 16 id. ("[aln epidemic of hypokinetic diseases including cardiovascular disease, cancer, and type ii diabetes, never before prevalent, began to be recognized as the leading causes of disease and death. the lifestyle improvements brought in part by the industrial revolution had apparently come with an unwanted and alarming cost to health."). 17 id. 634 vol. 10:2 the decline of mandatory physical education public schools that resulted in improved health for the overall population."18 however, "[t]he gains that physical education programs made through the passage of legislation following world war i were short-lived" as the nation's attention shifted to the reality of the great depression and subsequent developments in europe. 19 the united states unwillingly was drawn into "world war ii with the bombing of pearl harbor on december 7, 1941."20 "with the war came the need to once again draft military personnel".21 and again, during the draft, it became clear that many of the draftees were not physically fit for battle. 22 "when the war was over, it was reported that nearly half of all draftees [were] rejected or were given non-combat positions due to being overweight." 23 these alarming statistics once more attracted the attention of the country "with regards to the importance of [physical education]," and the government would once again try to re-introduce more stringent and pronounced physical education programs in the nation's public school system.24 at the heart of this renewed focus on physical education was the presidential council on youth fitness whose role was to advise the president-through the secretary of health and human services-about physical activity, fitness, and sports, and put forth programs to promote 18 id. (the article notes that national park service legislation designed to promote both physical and traditional education was passed in 1920. among them were: the american physical education association, the american association for health and physical education, the playground and recreation association, national code of standards for physical education and more.). 19 id. (explaining that "funding for these programs became limited and eventually was exhausted as emphasis in the poor economy was forced to shift elsewhere"). 20 id. 21 id 22 id 23 id. 24 id. 6352013 indiana health law review regular physical activity for the health of all americans. 25 since the establishment of the council, many changes in technologies, priorities and politics have continued to affect the development of physical education in the nation's public school system. these changes and their consequences are explored below. iii. decline of mandatory physical education in public schools and the subsequent rise in childhood obesity through a changing landscape the atmosphere that created the renewed focus on physical education after world war ii once again did not endure. greater and accelerated technological advances, the need to expand public schools curriculum, and budget crisis that began in the 1970s (and lasted through the 80s) brought to the forefront different priorities that would eventually bring an ensuing and protracted decline in mandatory physical education. 26 as mandatory physical education continued to decline and technology continued to facilitate a more sedentary lifestyle, the rise in childhood obesity gradually and progressively took hold.2 7 the 25 our history, pcfsn, http://www.fitness.gov/about-pcfsn/ourhistory/ (last visited jan. 30, 2012) (presenting the history of the presidential council on youth fitness). 26 emma murray, history of physical education in schools, ehow.com, http://www.ehow.com/about_6521673_history-physicaleducation-schools.html#ixzz lyuwwectz (last visited jan. 30, 2012) ("[i]n 1955, the president's council on physical fitness and sports was created to promote fitness among youth through pe programs in schools and other organizations, such as the ymca. in 1976, it reported that fewer than 40 percent of students in the public schools took part in daily pe activities. the daily requirements for pe in high schools that were stipulated by many states declined as a result of the addition of other elective subjects. moreover, recessions during the 1970s and 1980s resulted in cuts to several education programs in schools, including physical education."). 27 cynthia l. ogden et al., the epidemiology of obesity, 132 gastroenterology 2087 (2007), available at http://www.gastrojournal. org/article/s0016-5085(07)00579-3/abstract (last visited mar. 19, 2013); see also prevalence of sedentary lifestyle behavioral risk factor surveillance system, united states, 1991, cdc, http://www.cdc.gov/ mmwr/preview/mmwrhtml/ 00021313.htm (last visited jan. 30, 2013) vol. 10:2636 the decline of mandatory physical education following graph, compiled from data collected by the cdc, demonstrates the impact of declining levels of physical education on the prevalence of childhood obesity in the last quarter of the 20th century 28: f figure 1. trends in obesity among children and adolescents: united states, 1963-2008 40 30 20 ci. 6-11 yeaes 10 10-12-19 years~2-5 years 19631971-1974 1976-1980 1988-1994 19992003-1 20071965 2000 i 2004 i 2008 1966200120051970 year 2002 2006 note obesity is defined as body mass index (bmi) greater than or equal to sexand age-specific 95th percentile from the 2000 cdc growth chats sources cdcnchs, national health examnation surveys ii (ages 6-11), ill (ages 12-17), and national health and numition examination surveys (nhanes) i-1ll, and nhanes 1999-2000, 2001-2002, 2003-2004. 2005-2006, and 2007-2008, as the graph shows, when physical education was in the national consciousness (in the years following world war ii and prior to the financial crisis of the 1970s), childhood obesity had for the most part stabilized. 29 in fact, among twelve to nineteen year-olds, the already substantially low (defining sedentary lifestyle as "a medical term used to denote a type of lifestyle with no or irregular physical activity, and commonly characterized by sitting, reading, watching television and computer use for much of the day with little or no vigorous physical exercise"). 28 cdc grand rounds: childhood obesity in the united states, cdc (jan. 21, 2011), http://www.cdc.gov/mmwr/preview/mmwrhtml/ mm6002a2.htm (last visited mar. 19, 2013) (the article describes "the prevalence of obesity among children and adolescents, by age group, in the united states during 1963-2008. in the united states, childhood obesity affects approximately 12.5 million children and teens 17% of that population. changes in obesity prevalence from the 1960s show a rapid increase in the 1980s and 1990s, when obesity prevalence among children and teens tripled from nearly 5% to approximately 15%."). 29 id. 2013 637 indiana health law review level of childhood obesity actually saw a decline from 1972 to 1978.30 however, as national requirements started to give way to a more local/state base deferential system, the positive trend ended, and since, the childhood obesity rate has steadily and doggedly increased. 31 hence, the correlative rise in childhood obesity is shown on the graph. 32 this correlation, though debatable, cannot merely be discounted. such a sharp rise after what is manifestly a notable period of stability deserves profound scrutiny as the totality of this crisis within the framework of its effect on the nation's overall health and its associated costs is examined. in keeping with the concept of totality, it is necessary to ask whether there are other factors that might have contributed to, or might be responsible for the childhood obesity crisis. though the answer to this question may require a more comprehensive study, it should be noted that that during the 1970s televisions became a staple in american households, and that such a development could have contributed to the increase in the childhood obesity rate as both parents and children took to watching tv as opposed to taking a stroll at the neighborhood park. 33 while this historical development is important, its consequences were rather minimal-thereby making its contribution to the childhood obesity crisis negligible. 34 such a finding 30 id. at 43. 31 id. at 44. 32 id. at 46. 33 lynn spigel, make room for tv: television and the family ideal in postwar america 57 (1992). 34 william h. dietz, jr. & steven l. gortmaker, do we fatten our children at the television set? obesity and television viewing in children and adolescents, 75 am. acad. pediatrics 807 (1985), available at http://www.ncbi.nlm.nih.gov/pubmed/3873060 (last visited mar. 19, 2013) ("[t]he association of television viewing and obesity in data collected during cycles ii and iii of the national health examination survey were examined. cycle ii examined 6,965 children aged 6 to 11 years and cycle iii examined 6,671 children aged 12 to 17 years. included in the cycle iii sample were 2,153 subjects previously studied during cycle ii. these surveys, therefore, provided two crosssectional samples and one prospective sample. in all three samples, significant associations of the time spent watching television and the 638 vol. 10:2 the decline of mandatory physical education further highlights the effects of the decline of mandatory physical education and the subsequent epidemical rise in childhood obesity that followed. reintroducing mandatory physical education standards at all grade levels in the public school system is the right and proper step to resolving this devastating crisis. iv. proliferation of junk foods it is significant to recognize that the decline of mandatory physical education coincided with an unprecedented proliferation of the junk food industry. 35 the 1960s, 70s and 80s saw the industry reach a critical level of pervasiveness, and the trend continues today.36 it should also be noted that there have been some proposals, and (in some cases) actual regulations targeting the junk food industry. 37 the effects of these proposals/regulations, prevalence of obesity were observed. in 12to 17-year-old adolescents, the prevalence of obesity increased by 2% for each additional hour of television viewed. the associations persisted when controlled for prior obesity, region, season, population density, race, socioeconomic class, and a variety of other family variables. the consistency, temporal sequence, strength, and specificity of the associations suggest that television viewing may cause obesity in at least some children and adolescents. the potential effects of obesity on activity and the consumption of calorically dense foods are consistent with this hypothesis."); see also a growing problem, cdc, http://www.cdc.gov/ obesity/childhood/problem.html (last visited jan. 30, 2013) ("[clhildren 8-18 years of age spend an average of 7.5 hours a day using entertainment media, including tv, computers, video games, cell phones, and movies. of those 7.5 hours, about 4.5 hours is dedicated to viewing tv. eighty-three percent of children from 6 months to less than 6 years of age view tv or videos about 1 hour and 57 minutes a day. tv viewing is a contributing factor to childhood obesity because it may take away from the time children spend in physical activities."). 35 eric schlosser, fast food nation: the dark side of the all-american meal 3-8 (2007) (noting that "while the junk food industry was created in the early 20th century, it had not grown before like it did during the period in question"). 36 id. at 4. 3 rudd center releases unprecedented report on fast food nutrition and marketing to youth, yale rudd center (nov. 2010), http://www.yaleruddcenter.org/newsletter/issue.aspx?id=27 (last visited 6392013 indiana health law review however, have proven so far to be inconclusive. 38 based on currently available evidence, while junk foods can be said to be a contributing factor to the childhood obesity crisis, physical education arguably has been and remains the greater factor. 39 and historically, given that physical education was once embraced nationally as a way to curb the country's obesity problem, it is likely to be politically more palatable-making it easier to be federally legislated. v. the real cost of obesity as reflected in increased health care spending the high and growing cost of health care is a critical issue for businesses, workers, government and citizens alike.40 spending on health care for 2009 accounted for 17.6% of gdp which amounted to a record of $2.5 trillion.41 mar. 19, 2013) ("a struggle is occurring in san francisco about a proposed requirement for fast food meals to meet nutrient standards in order to include toys. sponsored by supervisor eric mar and approved by the board of supervisors, the proposal was vetoed by mayor gavin newsom. the board's eight of 11 votes in support of the proposal will allow it to override mayor newsom's veto."). 38 eileen salinsky, effects of food marketing to kids: i'm lovin' it? (2006), available at http://www.nhpf.org/1ibrarylissuebriefs/ib814_foodmarketing_08-15-06.pdf. 39 id. 40 neeraj sood et al., the effect of health care cost growth on the u.s. economy (2007), available at http://aspe.hhs.gov/health/reports/08/healthcarecost/report.html (last visited mar. 19, 2013) ("rising health care costs have generated concerns that continued growth could adversely affect the nation's economy, as well as pose problems for particular sectors of the economy, such as employers and households. this report evaluated how increased spending on health care affected aggregate economic indicators and individual sectors. as a basis for this investigation, a thorough and detailed review of the literature was conducted that included anecdotal evidence, survey findings and the peer reviewed literature. the literature review highlighted the economic effects of health care cost growth, and identified possible mechanisms through which cost growth could affect the aggregate economy, as well as government, households and business."). 41 national health expenditure data, cms (apr. 11, 2012), https://www.cms.gov/nationalhealthexpenddata/02_nationalhealthaccou ntshistorical.asp (last visited mar. 19, 2013). 640 vol. 10:2 the decline of mandatory physical education in 1970, the u.s spent about $75 billion on health care, or $356 per resident-which accounted for only 7.2% of gdp.4 2 as if the staggering increase over the past four decades is not alarming enough, the henry j. kaiser family foundation projects that by 2016 health care spending will be over $4.1 trillion, or $12,782 per resident, and account for 19.6% of gdp.43 this is what the united states faces if it fails to act to put a stop to run-away health care costs. promisingly, multiple studies have shown that addressing childhood obesity could significantly and meaningfully reduce these run-away costs and pre-empt further worsening of this crisis.44 based on the historical background, a federal mandate requiring minimum standards of physical education at all grade levels in the nation's public school system is an effective way to address the childhood obesity crisis while at the same time reversing the ever rising trend of health care expenditures. a. the scope of the problem and its undeniable gravity over the past four decades, the number of overweight children and adolescents has risen, and these increases cut across all racial and ethnic groups, and both genders. 45 studies have shown that overweight and obese children are at substantial risk of illness from high blood pressure, high 42 id. 43 kaiser family foundation, trends in health care costs and spending (2007), available at http://www.kff.org/insurance/upload/ 7692.pdf. 44 youfa wang et al., will all americans become overweight or obese? estimating the progression and cost of the us obesity epidemic, 16 obesity 2323 (2008), available at http://www. readcube.com/articles/10.1038/oby.2008.351 (last visited mar. 19, 2013) (predicting that "the prevalence of overweight children will nearly double by 2030 and that total health care costs attributable to obesity will double every decade to $860.7-956.9 billion by 2030"). 45 obesity-' halting the epidemic by making health easier, cdc (may 26, 2011), http://www.cdc.gov/chronicdisease/resources/publications/ aag/obesity.htm (last visited mar. 19, 2013). 2013 641 indiana health law review cholesterol, type ii diabetes, heart disease and stroke.46 because of the likelihood of diseases among obese children who most often grow up to be obese adults, there are enormous economic costs that are associated with this epidemic. 47 a recent study examining the impact of obesity on rising medical spending found that the increase in obesity contributed to inordinate spending increases for the three medical conditions examined (diabetes, hyperlipidemia, and heart disease).48 between 1987 and 2001, growth in obesity and spending on obese people accounted for 27% of the growth in inflation-adjusted per capita health care spending.49 furthermore, former united states surgeon general richard carmona recently stated that childhood obesity impacts not only children's personal health, but also society as a whole.50 it has been proven that the problem of childhood obesity goes beyond excess weight and disabling diseases to include negative impact on mental health and 46 id. ("obesity increases the risk of many health conditions, including the following: coronary heart disease, stroke, and high blood pressure, type ii diabetes, cancers, such as endometrial, breast, and colon cancer, high total cholesterol or high levels of triglycerides, liver and gallbladder disease, sleep apnea and respiratory problems, degeneration of cartilage and underlying bone within a joint (osteoarthritis), reproductive health complications such as infertility, and mental health conditions."). 47 id. ("in 2008, overall medical care costs related to obesity for u.s. adults were estimated to be as high as $147 billion. people who were obese had medical costs that were $1,429 higher than the cost for people of normal body weight. obesity also has been linked with reduced worker productivity and chronic absence from work."). 48 kenneth e. thorpe et al., trends: the impact of obesity on rising medical spending, healthaffairs (oct. 20, 2004), http:// content.healthaffairs.org/content/suppl/2004/10/15/hlthaff.w4.480.dc1 (last visited mar. 21, 2013). 49 id. 50 the growing epidemic of childhood obesity.' testimony before the subcommittee on competition, infrastructure, and foreign commerce, committee on commerce, science, and transportation, 109th cong. (2004) (statement of richard h. carmona, surgeon general), available at http://www.surgeongeneral.gov/news/testimony/ childobesity03022004.html (last visited mar. 21, 2013). 642 vol. 10:2 the decline of mandatory physical education school performance. 51 there is growing evidence documenting the association between obesity and poor mental health.52 researchers in the adult and community health division of the cdc analyzed 2006 "data and found that depression and anxiety are associated with obesity."53 as a result, they advised that "public health intervention [1 address mental and physical health as a combined entity, and that programs to simultaneously improve mental health and physical health should be developed and implemented."54 given the primacy of children to the nation's future, childhood obesity should be considered-as indicated by former surgeon general of the united states, dr. richard carmona-a "dire" threat to our society.55 considering the role of physical education in the history of obesity following world war i and ii, a federal program mandating minimum standards of physical education in the public school system is a demonstrated and established way to address this "dire" threat. vi. the current status of state laws and their documented failures support a federal mandate according to the cdc, "federal law does not prescribe minimum standards for physical education in schools." 56 the federal government instead "relies on grant programs administered by the departments of education and transportation to create incentives that promote [(not 51 mental health, stress and obesity, trust for america's health, http://healthyamericans.org/pages/?id=253 (last visited jan. 30, 2013). 52 id. 5s id. 54 id. 55 lovett anyachebelu, the obese epidemic threat to the nation's security, fort gordon signal (april 1, 2011), http:lwww. fortgordonsignal.com/news/2011-04-o1/newsupdate/theobese-epidemic threattothenations security.html (last visited mar. 21, 2013). 56 physical activity for school age children, cdc (apr. 13, 2012), http://www.cdc.gov/phlp/winnable/school activity.html (last visited mar. 21, 2013). 6432013 indiana health law review mandate)] physical activities in the school setting."57 without a federal mandate, "state and local jurisdictions have passed a variety of laws and policy "recommendations" that define minimum standards for time requirements and the quality of physical education and recess."5 8 below are examples of physical education laws and policy considerations for the state of oregon, arkansas, and tennessee. the oregon physical education requirements statute reads as follows: every public school student in kindergarten through grade [eight (8)] shall participate in physical education for the entire school year. students in kindergarten through grade [five (5)] shall participate in physical education for at least 150 minutes during each school week. students in grades [six (6)] through [eight (8)] shall participate in physical education for at least 225 minutes during each school week. 59 according to the national association of state boards of education in arkansas: act 317 (2007) requires [sixty 601 minutes per calendar week of physical education training and instruction for students in grades [five (5) through eight (8)] for schools organized to teach these grades. the statute requires [ninety (90)] minutes of additional physical activity per week for grades k-6, which may include physical education in addition to the previous requirement, daily recess, or intramural sports. code 20-7-135 (2003) calls on the state board of education to promulgate 57 id. 58 id. ("state and local quantitative policies vary ranging from no time requirement to an established minimum number of minutes students must participate in physical activity each week. qualitative standards also vary among jurisdictions . . ). 59 oregon educational act for the 21st century, or. rev. stat. § 329.496(1) (2012). 644 vol. 10:2 the decline of mandatory physical education rules and regulations to ensure physical activity standards are implemented to provide students with the skills, opportunity, and encouragement to adopt healthy lifestyles. the rules governing nutrition and physical activity standards and body mass index for age assessment protocols in arkansas public schools include the time requirements of act 317 (2007), and allow local districts to require physical education or activity in excess of these requirements.60 in tennessee, a policy task force, in response to its position on the importance of physical education, has published the following recommendations: children need opportunities to be physically active and have access to healthful foods in order to grow, learn, and thrive. physical activity needs to be balanced with good nutrition in order to create a healthy learning environment. physical activity has substantial health benefits for students including favorable effects on body weight, blood pressure, endurance capacity and physical strength to promote healthy lifelong learning. physical activity has been shown to promote good academic outcomes and to reduce barriers to learning. good health fosters student attendance in education and helps to increase a student's capacity for learning. community participation is essential to the development and implementation of school policies that 60 state school healthy policy database, nat'l ass'n of state bds. of educ., http://nasbe.org/healthy schools/hs/bytopics.php?topicid =1110&catexpand=acdnbtm_cata (last visited jan. 26, 2013). 2013 645 indiana health law review support and promote physical activity and good nutrition in the school setting.61 these types of laws and policy positions have been considered to varying degrees and, on occasions, adopted in several states.62 however, without federal minimum standards, local communities are often left to decide whether to include any physical education at all in their curriculum.63 in the face of budget restraints, and the fungibility of money (not to mention differing political approaches based on ideology), physical education expense is often the first school expense to be eliminated.64 despite a pronounced recognition of the importance of physical education in the school setting-as evidence by the many debates, policy consideration and attempts to pass legislation in this areamany of the measures that have so far emerged have contributed to more of a conceptual framework of physical education rather than explicit requirements (which are essential to implementing a successful physical education program in the public school system).65 to illustrate this point, in california, although physical education is required, a 2006 audit of the state's "public 61 physical activity policy, tenn. state bd. of educ. (apr. 15, 2005), http://www.tn.gov/education/schoolhealth/physed/doc/iiicphysical activitypolicy.pdf. 62 state legislative and regulatory action to prevent obesity and improve nutrition and physical activity, cdc, http://www.cdc.gov/ncedphp/ dnpaoldocs/chronic-disease-state-policy-traclkng-system-methodology-report-508.pdf. 63 id. 64 betsy hurd, physical education too valuable to sacrifice to budget cuts, mlive (feb. 6, 2010, 5:03 am), http://www.mlive.com/ opinion/saginaw/index.ssfl2010/02/physical education too valuabl.htm (last visited mar. 21, 2013). 65 melinda bossenmeyer, case study could shape physical education landscape across nation, peaceful playgournds, http://www.peacefulplaygrounds.com/physical-education-case-study.htm (last visited jan. 30, 2013) ("[physical education] is required, but it is not taught. according to the latest school health policies and program study report (2006)[il only 13.7% of elementary schools, 15.2% of middle schools and astonishingly, only 3% of high schools provided physical education at least 3 days per week or its equivalent for the entire school year for students in all grades in the school."). 646 vol. 10:2 the decline of mandatory physical education elementary schools found that less than 36% of the students were receiving elementary school physical education." 66 this phenomenon is not unique to california. the new york department of education recently released results of an audit that "found limited evidence that any of the sampled schools were in compliance with the physical education requirements." 67 this current state of affairs is unacceptable given that a great number of studies over the past decade have shown that physical activity is extremely important and positively correlated to a child's proper development (both mental and physical).68 against the background of current state laws that deals with physical education in the public school system, it is necessary to point out that physical inactivity, together with a poor diet have been said to account for at least 400 thousand deaths each year in the united states. 69 should this number be close to reality, obesity-related death would be second only to tobacco use as the leading cause of preventable death in the united states. 70 in the face of such 66 id. 67 john c. liu, audit report on the department of education's compliance with the physical education regulations in elementary schools (2011), available at http://www. comptroller.nyc.gov/bureaus/audit/pdffiles_2011/md11_083a.pdf. 68 hurd, supra note 64 ("when dr. david satcher, the former surgeon general, gave the martin luther king jr. address at saginaw valley state university in january, he emphasized the importance of physical education for every child. ironically, that same month, the buena vista school district cut physical education classes for all students in the district, from preschool through eighth grade. of course, schools need to focus on academics, but educators also need to focus on the whole individual including their physical and psychological wellbeing. physical education classes improve motor skills and hand-eye coordination, encourage cooperative learning and the team concept, reduce stress and anxiety and increase self-esteem. with the pressure of standardized testing in the classroom, students are challenged to learn more and more. this creates stress, which often erupts negatively. physical education classes provide an outlet for children to let off pentup energy in positive ways."). 69 katherine m. flegal et al., excess deaths associated with underweight, overweight, and obesity, 293 jama 1861 (2005). 70 j. michael mcginnis & william h. foege, actual causes of death in the united states, 270 jama 2207 (1993). 6472013 indiana health law review dire statistics and inordinate costs, not having a national program for implementing physical education in the public school system is irresponsible and reckless. because of the gravity of the problem and to reverse the current trend, it is critical that there be uniform federal minimum standards of physical education programs that could be incorporated into public schools curriculum. to the extent a particular state chooses to exceed the federal standards, it should be free to implement its own program. however, the federal standards would pre-empt any state law that falls short of its requirements. to understand why federal legislation is necessary, it is important to look at some of the states where standards are either completely lacking, fall short of anything reasonable, or are wholly conceptual in nature. for example the ten states with the highest childhood obesity rates as of 2008 have no physical activity requirement laws.71 these states are: kentucky, arkansas, texas, alabama, tennessee, south carolina, west virginia, missouri, mississippi, and michigan. 72 on the other hand, some of the states with the lowest childhood obesity rates, such as colorado and oregon, have some of the strictest requirements for physical education. 73 this is not likely a simple coincidence, even 71 f as in fat: how obesity threatens america's future 2011, trust for america's health (july 2011), http://healthyamericans. org/report/88/; childhood obesity 2008 update and legislative of policy options, national conference of state legislatures, http://www.ncsl.org/default.aspx?tabld=13883 (last visited mar. 21, 2013). 72 id. 73 colorado's children's wellness physical activity requirement statute declares that: (3)(a) each school district board of education shall adopt a physical activity policy that incorporates into the schedule of each student attending an elementary school the opportunity for the student to engage in. (i) a minimum of six hundred minutes of physical activity per month if the classes at the school meet five days per week and the student attends school for a full day; (ii) a minimum of three hundred minutes of physical activity per month if the classes at the school 648 vol. 10:2 the decline of mandatory physical education with the existence of outliers such as montana, where there are no strict requirements, and yet the childhood obesity rate is relatively low. montana is in stark contrast to a state like georgia where there are no physical education requirements and the childhood obesity rate is critically high.74 meet five days per week and the student attends school for a half day; (iii) a minimum of thirty minutes of physical activity per day if the classes at the school meet fewer than five days per week and the student attends school for a full day; and (iv) a minimum of fifteen minutes of physical activity per day if the classes at the school meet fewer than five days per week and the student attends school for a half day. (b) the physical activity policy may include an exception for any month that includes a planned or unplanned full-day or half-day school closure. colo. rev. stat. § 22-32-136.5 (2012); oregon's physical education participation; minimum requirements, exceptions, professional development statute declares that: (1) . . . students in kindergarten through grade 5 shall participate in physical eduction for at least 150 minutes during each school week. students in grades 6 through 8 shall participate in physical education for at least 225 minutes during each school week. (2) . . . the instruction shall be a sequential, developmentally appropriate curriculum that is designed, implemented, and evaluated to help students develop the knowledge, motor skills, self-management skills, attitudes and confidence needed to adopt and maintain physical activity throughout their lives. (3) school districts and public charter schools shall devote at least 50 percent of physical education class time to actual physical activity in each school week, with as much time as possible spent in moderate physical activity. or. rev. stat. § 329.496 (2012) (effective july 1, 2017). 74 how obesity threatens america's future 2011, supra note 71; 2008 update and overview of policy options, supra note 71. 6492013 indiana health law review while recognizing that a federal mandate requiring minimum standards of physical education be incorporated in the nation's public schools curriculum at all grade levels is necessary and imperative to address the childhood obesity crisis, it is important to acknowledge that childhood obesity has a direct impact on states, and that each state could arguably have good reasons to design specific or unique individual programs. however, while a state by state solution may seem theoretically more appropriate, federal minimum standards will not defeat state initiatives as states should be allowed to go above and beyond federal standards. in states that have no standards or their standards fall short of the federal minimum requirements, the federal standards will prevail. for example, in a state like indiana where the law-with respect to childhood obesity-is almost wholly conceptual (no established state task force, no bmi screening mandate, no physical activity requirements), and the legislature has not been able to amass enough political support to advance any new legislation that could make a meaningful difference in the state's childhood obesity rate (29.9% as of 2007), federal standards will prevail provided such standards can withstand potential constitutional challenges.75 vii. a federal mandate will withstand a constitutional challenge the greatest handicap facing any federal mandate designed to incorporate minimum standards of physical education into the public school system is a constitutional challenge. it could be argued that congress's enumerated powers described in articles 1 through 8 of the constitution do not expand into regulating the shapes and sizes of 75 the henry j. kaiser family foundation, indiana: state laws addressing childhood obesity, 2011, statehealthfacts.org, http://www.statehealthfacts.org/profileind.jsp?rgn=16&ind=52&cat=2 (last visited jan. 14, 2013); issues and research: childhood overweight and obesity trends, national conference of state legislatures, http://www.ncsl.org/?tabid=13877 (last visited jan. 14, 2013). 650 vol. 10:2 the decline of mandatory physical education children of the united states.76 it could also be argued that the tenth amendment implicitly places such regulation within the domain of state power. 77 in addition, within the context of the state police power to regulate health, safety, welfare and morals,78 it could be argued that the federal government will over-extend its power by trying to regulate an area that is traditionally governed by state laws. 79 notwithstanding, the u.s supreme court, in united states v. darby, concluded that the tenth amendment will not stand in the way of the federal government.80 the 76 u.s. const. art. i, § 8: congress shall have power to lay and collect taxes, duties, imports and excises, to pay the debts and provide for the common defence and general welfare of the united states; . . . to borrow money on the credit of the united states; to regulate commerce . . .; to establish a uniform rule of naturalization, and . . . bankruptcies . . .; to coin money . . .; to establish post offices . . .; to promote the progress of science and useful arts . . .; to constitute tribunals inferior to the supreme court; to define and punish piracies and felonies committed on the high seas . . ; to declare war .; to raise and support armies . . .; to provide and maintain a navy. 77 u.s. const. amend. x (specifying that "[t]he powers not delegated to the united states by the constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people"). 78 jorge e. galva et al., public health strategy and the police powers of the state, 120 pub. health rep. 20 (2005), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2569983/ (last visited jan. 14, 2013). 79 solid waste v. us army corps of engineers, 531 u.s. 159 (2001) (striking down a federal land use regulation by concluding that local land use regulation is expressly reserved to the states by the tenth amendment). 80 united states v. darby, 312 u.s. 100, 124 (1941) (holding that "the 10th amendment states but a truism that all is retained which has not been surrendered"). the court in darby further said that "there is nothing in the history of its adoption to suggest that it was more than declaratory of the relationship between the national and state governments as it had been established by the constitution before the amendment or that its purpose was other than to allay fears that the 2013 651 indiana health law review supreme court rarely declares laws unconstitutional for violating the tenth amendment.81 for example, in new york v. united states, the court ruled that the tenth amendment is violated in cases where the federal government compels the states to enforce federal statutes. 82 notwithstanding, despite finding that the federal government had overreached in its powers, justice o'connor, writing for the majority, explicitly stated that the federal government can impose on the states certain regulations through the spending power (e.g. by attaching conditions to the receipt of federal funds).83 such probative federal jurisprudential precedents make it more difficult to argue that federal minimum standards for physical education will not withstand a constitutional challenge. furthermore, the school setting is one of the most appropriate places to apply the model announced in new york v. united states (and also south dakota v. dole) because the federal government currently provides substantial funding to the states for school related new national government might seek to exercise powers not granted, and that the states might not be able to exercise fully their reserved powers." 81 see generally new york v. united states, 505 u.s. 144, 149 (1992) (recognizing for only the second time within a fifty-five year span that the court invalidated a portion of a federal law for violating the tenth amendment). 82 see generally id. (illustrating when the supreme court would invalidate a federal law for violating the tenth amendment). new york v. united states involved a challenge to a portion of the low-level radioactive waste policy amendments act of 1985. the act stipulated three incentives for states to comply with congressional statutory obligations to accommodate the disposal of low-level radioactive waste. the first two incentives were pecuniary. the third, which brought about the constitutional challenge, obligated states to take title to any waste within their borders that was not disposed of prior to january 1, 1996, and made each state liable for all damages directly related to the waste. the court ruled that the imposition of that obligation on the states violated the tenth amendment. justice sandra day o'connor indicted that the federal government can encourage the states to adopt certain regulations through the spending power (e.g. by attaching conditions to the receipt of federal funds). see also south dakota v. dole, 483 u.s. 203 (1987). 83 dole, 483 u.s at 206 (concluding that congress may attach reasonable conditions to funds disbursed to the states). 652 vol. 10:2 the decline of mandatory physical education expenditures. 84 states have often consented to federal requirements in order to access federal grants and other resources. 85 for example, states cannot receive federal highway funding unless they implement federally-approved speed limits and drinking ages.86 universities cannot receive federal research funding if they do not provide gender parity in athletic offerings.87 historically, states must offer a prescribed curriculum (including science) in order to receive federal grants for higher education.88 also, in the mid-1960s federal grants were used to influence southern school boards to adopt extremely unpopular conditions-desegregating students and teachers in public schools.89 more recently, according to elizabeth cascio (cited above), the threat of withdrawal of federal education funds "has been used to encourage states and districts to comply with the accountability requirements under the no child left behind act."90 it is well established that the federal government can use its constitutional spending power to affect state and local policies.91 a federal mandate requiring minimum standards of physical education in grade schools-under the threat of withholding federal funds-is no different than any of the above mentioned laws that have 84 summary of discretionary funds, fy2009 request, u.s. dept. of educ. (jan. 31, 2008), http://www2.ed.gov/about/overview/budget/ budget09/summary/appendixl.pdf (last visited jan. 14, 2013). 85 robert jay dilger, cong. research serv., r 40431, federalism issues in surface transportation policy: past and present (2011), available at http://assets.opencrs.com/rpts/r4043120110420.pdf. 86 dole, 483 u.s. at 205. 87 see generally favia v. indiana university of pennsylvania, 7 f.3d 332 (3rd cir. 1993). 88 see generally elizabeth cascio et al., paying for progress. conditional grants and the desegregation of southern schools, 125 q.j.econ. 445 (2010), available at http://l1.ccpr.ucla.edu/papers/qjep4p.pdf. 89 id. 90 id. at 445. 91 dole, 483 u.s. at 204 (ruling that congress could use its taxing and spending clauses to pressure states to comply with national drinking-age standards). 2013 653 indiana health law review been found to be constitutional. therefore, such a mandate is likely to be ruled constitutional as well. for those who think the federal government cannot be the solution, it should not be forgotten that regulations that are now taken completely for granted sparked fierce controversy in their time (clean air act, clean water act).92 many often characterized legislation such as the clean air act and the clean water act as being paternalistic and as power grabs by the government. 93 few, today, will argue the nation has not benefited from these legislations. in a more recent example, the first reports recommending that government be involved in regulating the tobacco industry were controversial. 9 4 some, defending smokers' rights, denounced a tobacco tax and potential advertising bans as an assault on liberty, and as health education propaganda. 95 while the debate might not be fully settled today, benefits that continue to flow from regulating the tobacco industry are quite measurable. 96 it is critical to 92 edmund s. muskie, the clean air act: a commitment to public health http://www.cleanairtrust.org/nepa2cercla.html (last visited mar. 9, 2013); see also levin statement in opposition to the clean water cooperative federalism act, http://levin.house.gov/levin-statementopposition-clean-water-cooperative-federalism-act (last visited mar. 9, 2013). 93 id. 94 joanna e cohen et. al, political ideology and tobacco control http://tobaccocontrol.bmj.com/content/9/3/263.full (last visited mar. 9, 2013). 95 id. 96 lorenzo richiardi et al., cardiovascular benefits of smoking regulations: the effect of decreased exposure to passive smoking, 48 preventive med. 167 (2009), available at http://www.sciencedirect.com/ science/article/pii/s0091743508006294: studies conducted in the usa and europe have shown a reduction in the number of hospital admissions for acute myocardial infarction (ami) in the months following the introduction of regulations banning smoking in public places. ([sargent et al., 2004], [barone-adesi et al., 20061, [bartecchi et al., 20061, [cronin et al., 20071, [juster et al., 2007], [khuder et al., 20071, [seo and torabi, 20071, [cesaroni et al., 20081, [lemstra et al., 2008], [pell et al., 20081). . . . the decreases observed 654 vol. 10:2 the decline of mandatory physical education understand that these regulations govern broad social issues with national effects that can be better categorized as infrastructure issues that are outside the scope of one individual, but from which each can benefit. their goals (regulations) are to promote the nation's general welfarecongress' primary duty under the constitution.97 critics may respond to government intervention in relation to individual lifestyle and behavioral choices with rousing cries for personal liberty, and claim that such micromanagement of the individual is a manifestation of authoritarianism. 98 however, dismissing government intervention as authoritarianism, or the emergence of absolutism limits debate about the possible benefits of such intervention.99 any government that wants to change the behavior of companies or the public in response to a perceived or actual health risk (such as the one presented by the childhood obesity crisis) must be willing to take bold steps for the greater good. a federal program mandating minimum standards of physical education in the nation's public schools is a bold step for the greater good and the nation's general welfare. it could debatably be said that almost every government intervention in the public arena, at one time or another, have been criticized as a sign of tyranny, "nanny-statism", or the end of individual freedom. yet the subsequent evidence often unmasks the appreciable individual and public health benefits of once-highly opposed interventions.100 these results arguably mitigate the ranged from a 40% decrease found in helena, montana, usa (sargent et al., 2004) to an 8% reduction seen in the state of new york. (juster et al., 2007). smoking regulations decrease exposure to passive smoking and may indirectly decrease active smoking. 97 u.s. const. art. i, § 8. ("congress shall . . . provide for the common defense and general welfare of the united states."). 98 [d. 99 j. hoek, public health, regulation and the nanny state fallacy, http://ro.uow.edu. au/cgi/viewcontent.cgi?article=100 1&context= insm08 (last visited mar. 9, 2013). 100 epa, benefit and costs of the clean air act, http://www.epa. gov/air/sect812/economy.html (last visited mar. 9, 2013). 2013 655 indiana health law review negative effects from limitations on individual freedom and choice. as opposed to blanket criticism of unwarranted government interference, one must look at such government necessitated intervention as "stewardship" to understand the justification and impact. stewardship implies that government has a responsibility for protecting national health, and to serving in the public interest and for the public good.101 while the concept of free market, state rights and freedom of choice are noble and must be defended, anchoring critical choices for the nation's well-being to a distinct political ideology advances neither free market, nor state rights, or freedom. the solution to the childhood obesity crisis should not be required to first worship at the foothill of political dogma. some political theorists take the position that such government intervention is not in conflict with individual freedom. sunstein and thaler, for example, propound that public policy helps to eliminate obviously bad choices and encourages more positive ones to promote individual and general well-being.102 certainly, most would like to see childhood obesity become a thing of the past. if government intervention can make it easier to accomplish such an important goal, then it is quite intransigent to argue that requiring physical education in public schools is an affront on individual liberty. overweight children and obesity-related expenses affect everyone. the social stigma and the increased health care expenses associated with childhood obesity necessitate and reflect the urgency of a comprehensive undertaking of the national government. given that up to 80% of the nation's children attend public schools, a government intervention through the public school system would effectively reach the 101 see generally richard b. saltman & odile ferroussier-davis, the concept of stewardshup in health policy, 78 bull. world health org. 732 (2000), available at http://www.scielosp.org/pdf/bwho/v78n6/ v78n6a05.pdf. 102 see generally cass r. sunstein & richard h. thaler, libertarian paternalism is not an oxymoron, 70 u. chi.l. rev. 1159 (2003). 656 vol. 10:2 the decline of mandatory physical education targeted audience. 103 a recent position statement issued by the american heart association supports this assertion, concluding that "schools could become the central element in a system that ensures that students participate in enough physical activity to develop healthy lifestyles." 10 4 currently, most states require some form of physical education in schools-though many are conceptual and with great disparity. 05 to address both the conceptual and the disparity problems, a comprehensive federal mandate, with specific standards, requiring the incorporation of physical education into the nation's public school curriculum is the solution. given the challenges that the united states faces as a nation, it must come together to defeat this crisis. while some might question the constitutional power of the government to require minimum standards of physical activity at all grade levels in all public schools, these types of questions, as indicated above, permeated the regulation of the tobacco industry during the 1980s and 90s. as it has become less and less debatable that the childhood obesity crisis is a national problem, it should be addressed at the national level, and the role of the federal government should be recognized and accepted.106 besides, the judicial 103 inst. of educ. and science, fast facts, national center for education statistics, http://nces.ed.gov/fastfacts/display.asp?id=6 (last visited jan. 14, 2013). 104 russell r. pate, et al., promoting physical activity in children and youth, 114 circulation: am. heart assoc. 1214 (2006), available at http://circ.ahajournals.org/content/114/11/1214.full (arguing that "[iit appears the time has come to consider a markedly expanded role for schools in providing physical activity to our children and youth. schools could become the central element in a . . . system that ensures that students participate in enough physical activity to develop healthy lifestyles"). 105 f as in fat: how obesity threatens america's future 2010, trust for america's health (june 2010), http://healthyamericans. org/reports/obesity2010/ (stating that "[elvery state has some form of physical education requirement for schools, but these requirements are often limited, not enforced or do not meet adequate quality standards"). 106 president barack obama, presidential proclamation--national childhood obesity awareness month, whitehouse.gov (september 01, 2010),http://www.whitehouse.gov/the-press-office/2010/09/01/ presidential2013 657 indiana health law review precedents make it likely that federally mandated minimum standards enforced through the government spending power will likely sustain any potential constitutional challenge. 107 viii. solutions to the problems of childhood obesity a. principal in august 1994, the american heart association's children's heart health conference met to identify strategies for promoting healthier children. at the end of the conference, the organization's "recommendations regarding children's physical activity were developed to conform to the goals of healthy people 2000 as well as the recommendations from the american heart association task force on physical activity."108 its guidelines for physical education programs are outlined below and are built upon to provide a more comprehensive approach to resolving this crisis: proclamation-national-childhood-obesity-awareness-month (last visited jan. 14, 2013). president barack obama established that september is national childhood obesity awareness month, proclaiming that: one of the greatest responsibilities we have as a nation is to safeguard the health and well-being of our children. we now face a national childhood obesity crisis, with nearly one in every three of america's children being overweight or obese. there are concrete steps we can take right away as concerned parents, caregivers, educators, loved ones, and a nation to ensure that our children are able to live full and active lives. during national childhood obesity awareness month, i urge all americans to take action to meet our national goal of solving the problem of childhood obesity within a generation. 107 south dakota v. dole, 483 u.s. 203, 206-07 (1987); see also new york v. united states, 505 u.s. 144, 171-73 (1992). 108 samuel s. gidding et al., improving children's heart health: a report from the american heart association's children's heart health conference, 65 j. sch. health 129 (1995), available at http:// onlinelibrary.wiley.com/doi/10.1111/j.1746-1561.1995.tb06215.x/abstract. 658 vol. 10:2 the decline of mandatory physical education a. "provide enjoyable experiences that enhance students' confidence in their ability to engage in physical activity."109 this can be expanded upon by developing a national strategic plan to increase physical activity. such can be accomplished (in part) by earmarking transportation funding to increase physical activity (e.g., bike and walking paths, buses with bike racks, traffic calming), and by designing activity-friendly communities. b. "provide a significant percentage of students' recommended weekly amount of physical activity."110 current laws in states like colorado and oregon-where the legislatures unequivocally mandate the amount of physical activities that students must be exposed to as part of the overall curriculum-is a "starting point" for a federal mandate.11 ' "starting point" is emphasized because federal standards do not have to mirror these laws; rather they could be adjusted, or be built upon for a more complete approach. c. "develop participation competence in developmentally appropriate physical activities."112 this is to say that physical activity is not a one size fits all; therefore, activities need to be tailored to a child's appropriate age and condition(s). d. "impart knowledge about the health benefits of physical activity."113 this can be done by supporting programs that teach both parents and children about the benefit of physical activity. such programs can be funded through conditional federal grants. e. "promote mastery of behavioral skills needed for maintenance of an active lifestyle."114 109 id. 110 id 111 colo. rev. stat. § 22-32-136.5 (2012); or. rev. stat. § 329.496-2 (2012). 112 gidding, supra note 108, at 129. 113 id. 114 id. 6592013 indiana health law review it is important to recognize that winning the fight against childhood obesity should not be seasonal or cyclical. children need to be taught that maintaining an active lifestyle does not end beyond the school walls, and that it should be part of everything they do. f. "promote students' participation in physical activity in school, community, and home settings."115 these can be done by promoting walking and biking to school; enhancing physical education; offering incentives for physical activity, striving to decrease sedentary behaviors; and encouraging celebrities to help promote physical activity and healthy eating.116 taken together, these are all activities that can and should be implemented through a federally mandated program. based on the supreme court precedents, it is well within the federal government authority to establish such a mandate using the spending power.117 b. alternative solution the federal government could simply provide the necessary funding while allowing states to fashion programs and choose how these programs are implemented. such an approach would seek to strengthen existing requirements that are working-such as those in oregon and colorado, to incentivize states with no requirements whatsoever to take the first step, and to hasten potential initiatives that may 115 id. 116 marion nestle, food marketing and childhood obesity a matter of policy, new engl. j. med. 2527 (2006), available at http://www.nejm.org/doilfull/10.1056/nejmp068014. nestle discusses whether food marketing is responsible: "[t]he [institute of medicine ("1om")] analyzes the results of 123 published, peer-reviewed studies addressing links between food marketing and children's preferences, requests, consumption, and adiposity. despite talmudic parsing of the limitations of the research, the iom finds that the preponderance of the evidence supports the links" that food marketing is a contributing factor as it promotes unhealthy eating. unhealthy eating is, at least minimally, a contributing factor to the childhood obesity crisis. 117 see generally south dakota v. dole, 483 u.s. 203 (1987); new york v. united states, 505 u.s. 144, 167-68 (1992). 660 vol. 10:2 the decline of mandatory physical education be hobbling along due to financial strain.118 however, given the experiences of the past decades, which unequivocally highlight the states' failures in addressing the childhood obesity crisis, there ought to be tremendous reservation to letting the states once again take almost complete charge of any attempt at a solution to the childhood obesity crisis. 1 19 ix. conclusion childhood obesity is a national problem that has so far contributed tremendously to the amount of money the nation spends on health care. this crisis demands a national solution. while it is in the interest of our system of federalism to respect and preserve states' power to police health, safety, morals and welfare of their own citizens, it is important to understand that a changing environment has caused the childhood obesity epidemic, and that the environment, as it is today, is an appropriate place for federal intervention. addressing this problem has been difficult (as evidenced by the historical records of obesity in general and childhood obesity in particular) and remains costly; thus prevention must be a national priority. justice silberman (of the district of columbia circuit), in upholding the affordable care act in 2011, reminded us that almost half a century ago, the supreme court declared in heart ofatlanta motel v. united states that "the right to be free from federal 118 see generally colo. rev. stat. § 22-32-136.5 (2012); or. rev. stat. § 329.496 (2012). 119 public health law: winnable battles, physical activity for school age children, centers for disease control and prevention, http://www.cdc.gov/phlp/winnable/school-activity.html (last visited jan. 14, 2013). according to the cdc, "federal law does not prescribe minimum standards for physical education in schools; instead, the federal government relies on grant programs administered by the departments of education and transportation to create incentives that promote [(not mandate)] physical activity in the school setting." those incentives have not been successful in pushing states to adopt meaningful physical education laws as evidenced by many states that either have adopted a conceptual framework of physical education without actual requirement. 6612013 indiana health law review regulation is not absolute, and yields to the imperative that congress be free to forge national solutions to national problems, no matter how local-or seemingly passive-their individual origins."120 given the documented failures of the states to resolve this issue of childhood obesity, 121 a federal mandate requiring all public schools to incorporate specific standards of physical education in their curriculum is necessary to bring about uniform compliance that would ensure a comprehensive approach to this exigency. 120 see susan seven-sky v. eric holder, no. 1:10-cv-00950 (2011); see heart of atlanta motel, inc. v. united states, 379 u.s. 241, 258-59 (1964). 121 how obesity threatens america's future 2010, supra note 105. 662 vol. 10:2 gestational surrogacy agreements: why indiana should honor them and what physicians should know until they do gestational surrogacy agreements: why indiana should honor them and what physicians should know until they do alyssa james* i. introduction .............................. ..... 176 ii background .................................... 178 iii. confusion surrounding gestational surrogacy arrangements ........................... ...... 181 a. issues with birth certificates........ ......... 181 b. varying outcomes between/within states.............. 182 1. varying outcomes and custody disputes............. 182 2. pre -birth parentage orders. ....... .......... 184 iv. current gestational surrogacy laws and models of other states .......................... ...... 187 a. indiana's current gestational surrogacy laws ...... 187 1. statutorylawin indiana.............. ..... 187 2. case law in re paternity and maternity of infant r. .............................. ........ 190 3. public policy rationale behind indiana's gestational surrogacy la ws .............................. 191 a. social mores that cause opposition to gestational surrogacy..............................191 b. alternative arguments to policy concerns...........195 b. florida's recognition and strict regulation of gestational surrogacy.... ................... 199 c illinois's welcoming gestational surrogacy laws... 200 v. benefits of adopting illinois-style legislation.. 203 a. intended parents would have security in the outcomes of their arrangements.... ........... 203 b. the intent of the parties would be a determining factor in declaration ofparentage............. 205 c pre-birth determinations ofparentage would be predictable and readily available.. ..... ........ 207 * j.d. candidate, 2013, indiana university robert h. mckinney school of law; b.a., 2009, butler university. indiana health law review d. surrogates will be confident in the outcomes of their arrangements ............................ 207 e. hospitals and physicians will be confident in their patient care decisions ................. .... 208 vi. best practice suggestions for physicians and hospitals until indiana regulates and recognizes gestational surrogacy agreements . ........... 208 vii. conclusion .............................. ..... 209 i. introduction in the united states, approximately ten percent of women of childbearing age deal with infertility1 and 7.1% of married couples are infertile.2 this struggle with infertility, along with the desire to have a child genetically linked to the parents, causes many couples to undergo significant financial and emotional stress in an attempt to have a family. gestational surrogacy (as well as traditional surrogacy) has allowed many of these women and couples to become parents to children that they may have been unable to have.3 traditional surrogacy is the process by which the 1 promoting pregnancy wellness: statistics, am. pregnancy ass'n, http://www. americanpregnancy.org/main/statistics.html (last visited aug. 17, 2012) (there are sixty million women of child bearing age (15-44) in the united states; six million of these women deal with infertility.). 2 kevin yamamoto & shelby a.d. moore, a trust analysis of gestational carrier's right to abortion, 70 fordham l. rev. 93, 99-100 (2001) (for this statistic, "a couple is defined as 'infertile' if they cannot conceive a child within one year of having frequent, unprotected intercourse. in contrast to those who are unable to conceive within one year, ninety percent of couples, both of childbearing age, who engage in intercourse without using birth control for one year will conceive." additionally, "the number of infertile women and couples in the united states is expected to climb dramatically over the next twenty-five years."). 3 alayna ohs, the power of pregnancy.* examining constitutional rights in a gestational surrogacy contract, 29 hastings const. l. q. 339, 339 (2002) ("while surrogacy allows numerous individuals and couples to parent children in situations that might not otherwise be 176 vol. 10:1 2013 gestational surrogacy agreements in indiana intended father and the surrogate have a child that is genetically linked to both of them.4 gestational surrogacy allows the intended parent(s) to have a child, through advanced reproductive technology, that is either genetically linked to themselves or a donor (the surrogate has no genetic connection to the child).5 as one woman describes, after facing years of infertility, a miscarriage, and losing all four of her quadruplets that were born prematurely, gestational surrogacy was the last hope for her and her husband to parent a biological child.6 indiana law currently does not honor surrogacy agreements of any kind, including gestational surrogacy agreements. the indiana legislature should reevaluate the potential policy concerns surrounding gestational surrogacy and pass legislation setting forth requirements under which gestational surrogacy agreements will be honored; however, until this occurs, indiana physicians must educate themselves on the implications of the law in order to limit their liability when dealing with childbirths resulting from these arrangements. part ii of this note will discuss general background information regarding gestational surrogacy, the agreements relating to this arrangement, and the physical, emotional, and financial stresses that intended parents face when entering into these arrangements. the confusion surrounding the outcomes of gestational surrogacy agreements, including issues with birth certificates and the possible, these developments have caused scholars and courts substantial concern. surrogacy law is unresolved in many places."). * harold s. eskin, surrogacy overview, legalsurrogacy.com, http://www.legalsurrogacy.com/surrogacy-overview.htm (last visited aug. 24, 2012). 5 id. (describing that, in states that honor these agreements, the ease of drafting the legal agreements in order to honor the parties' intentions). 6 michelle ford, gestational surrogacy is not adultery: fighting against rehgious opposition to procreate, 10 barry l. rev. 81, 81-82 (2008) (describing the author's own heartbreaking struggles through fertility treatments and lost pregnancies, while maintaining the desire of parentage. the author and her husband underwent an eight-year rollercoaster in order to have a child that was genetically linked to them. for them, gestational surrogacy was their last and only hope for having a genetic child.). 177 indiana health law review varying outcomes between and within states will be examined in part iii. part iv will examine the current indiana laws regarding gestational surrogacy, the public policy considerations that have shaped those laws, and model gestational surrogacy statutes of florida and illinois. part v will evaluate the benefits of indiana adopting an illinois-style system of regulating and acknowledging gestational surrogacy agreements, including the security in the outcomes for intended parents and surrogates, the use of intent to determine parentage, the predictability and availability of pre-birth parentage orders, and the predictability for hospitals and physicians. lastly, part vi of this note will make best practice recommendations for physicians and hospitals dealing with infants born from a gestational surrogacy arrangement under the current indiana laws. ii. background there are two different types of surrogacy arrangements: traditional surrogacy and gestational surrogacy. traditional surrogacy is a surrogacy relationship in which the child is genetically linked to the surrogate.7 in a traditional surrogacy relationship, the genetic father of the child may either be the intended father or a donor of the genetic material. 8 it is important to note that, in these types of surrogacy arrangements, the intended mother is never genetically related to the child.9 contrastingly, gestational surrogacy is a surrogacy relationship in which the surrogate has no genetic link to the child.10 most often, both of the intended parents contribute genetic material to be implanted into the surrogate." gestational surrogacy arrangements may also involve a donor of the genetic 7 denise e. lascarides, a plea for the enforceability of gestational surrogacy contracts, 25 hofstra l. rev. 1221, 1225-26 (1997). 8 id. 9 id. 10 id. at 1226. 11 id. vol. 10:1178 2013 gestational surrogacy agreements in indiana material of the male, female, or both.12 however, this note will focus on gestational surrogacy arrangements in which the intended parents are also the genetic parents of the child. the first child in the united states to be born out of a gestational surrogacy arrangement was born in 1985.13 the federal government has not established a role for itself in reproductive technology regulation; therefore, states are left to determine their views regarding gestational surrogacy and other reproductive technologies. 14 states vary greatly in their interpretations and acknowledgements of gestational surrogacy agreements; in many states, surrogacy law is unresolved or ruled to be illegal altogether.' this variance of the laws between states can make navigating reproductive technologies, especially gestational surrogacy, very challenging for intended parents, surrogates, attorneys, and physicians. gestational surrogacy is not an arrangement that intended parents andlor surrogates enter into lightly. it is a process that involves significant medical procedures and expense. in order to complete a successful gestational surrogacy process, the intended mother (or egg donor) must first have her eggs harvested, potentially using fertility drugs to increase egg production. 16 the intended mother 12 id. 13 id. 14 tenth annual review of gender and sexuality law: health care law chapter: assisted reproductive technologies, 10 geo. j. gender & l. 859, 859-60 (james w. ringo ed. 2009); see also lascarides, supra note 7, at 1227 ("since congress has yet to enact federal legislation relating to such contracts, the issue has not been resolved consistently by the state courts and state legislatures."). 15 ohs, supra note 3, at 339-40; lascarides, supra note 7, at 1227 ("[clertain states may become havens for infertile couples seeking children through traditional or gestational surrogacy. uniform regulation is needed so that infertile couples in every state are offered the same opportunity to produce a genetic offspring through surrogacy arrangements."). 16 the gestational surrogacy process: an overview of a typical ivf cycle, allaboutsurrogacy.com, http://www.allaboutsurrogacy. com/gsprocess.htm (last visited aug. 3, 2012) (asserting that by 179 indiana health law review and the surrogate must also synchronize their menstrual cycles, which requires multiple injections and medications; finally, the eggs are retrieved from the intended mother.17 the eggs are then incubated in a laboratory until the father (or donor) produces a sperm sample to inseminate the eggs in a laboratory dish via in vitro fertilization (forming embryos).18 these embryos are then transferred into the surrogate's uterus and a pregnancy test is performed two weeks later to determine whether or not the procedure was successful.19 intended parents often prefer gestational surrogacy because they desire a genetic child.20 parents often have the assumption that a child that is genetically linked to them will be more likely to be awarded to them in the event of a custody dispute with the surrogate. 21 as will be evaluated in this note, this is not always the case; however, gestational surrogacy arrangements are typically more promising for intended parents than traditional surrogacy arrangements. in the event of a custody dispute between the intended parents and the surrogate, a surrogate with no genetic ties to the child has a much lower chance of being awarded custody of the child.22 increasing the number of eggs removed from the intended mother, the number of potential embryos will also increase, thus further increasing the likelihood of pregnancy). 17 id. 18 id. 19 id. ("the embryo transfer may be done 3-5 days after the retrieval. the physician performing the transfer will discuss with the carrier and the intended parents the status of the embryos and the number to be replaced. the number of embryos transferred varies according to their quantity and quality. at this point, there may be an opportunity to cryopreserve any remaining embryos that continue to develop normally, for possible transfer in future cycles." if the pregnancy test is positive, the surrogate will typically maintain visits to the fertility doctor for several weeks before visiting the obstetrician of her choice.). 20 amy m. larkey, redefining motherhood: determining legal maternity in gestational surrogacy arrangements, 51 drake l. rev. 605, 611 (2003). 21 id. 22 see generally id. (stating that "the absence of a genetic link 180 vol. 10:-1 gestational surrogacy agreements in indiana iii. confusion surrounding gestational surrogacy arrangements a. issues with birth certificates traditionally, there was no legal definition of the word 'mother' because there was no other way for someone to become a mother other than giving birth to a child. 2 3 because there is no legal interpretation of the word 'mother,' much controversy arises when a court must determine the legal mother of a child born via gestational surrogacy.24 in indiana, as in many other states, the gestational surrogate/birth mother's name is most often placed on the birth certificate and the intended mother later must petition the court for the mother's name to be changed to her name. 25 very rarely do gestational surrogates want their name to be listed on the child's birth certificate at all; they would rather have the intended parents assume all responsibility of the child upon birth.26 some states have ruled that forcing the birth mother to place her name on the between the surrogate and child arguably creates a stronger legal position for the biological parents in the event of a legal custody battle"). 23 erin y. hisano, gestational surrogacy maternity disputes: refocusing on the child, 15 lewis & clark l. rev. 517, 519 (2011). 24 id. for example, in the case of scott and amy kehoe, who enlisted a gestational surrogate to have their child, the surrogate was ruled by the court to be the legal mother of the twins she birthed for the kehoes. id. in this instance, the kehoes used the reproductive material from a male and female donor, meaning they were not the genetic parents of the twins; however, the gestational surrogate was also not genetically related to the children. id. in this case, the gestational surrogate decided to assert her right under michigan law to keep the twins when she learned that amy kehoe "had a history of mental illness and a minor criminal record." id. the kehoes chose "not to pursue any further legal action." id. 25 michele l. jackson & lynn mullins-owens, assisted reproductive technology indiana: the latest legal news on surrogacy, artificial insemination, and donor arrangements (jocham harden dimick & jackson, pc, carmel, ind.), spring 2011, at 3. 26 see tenth annual review, supra note 14, at 877-78; ashley e. bashur, whose baby is it anyway? the current and future status of surrogacy contracts in maryland, 38 u. balt. l. rev. 165, 178-79 (2008). 1812013 indiana health law review certificate when she does not desire to do so violates the equal rights amendment because it prevents "women from denying maternity while allowing men to deny paternity."27 because men cannot be forced to have their name listed on a child's birth certificate without the chance to prove their lack of paternity, women should be afforded this same right.28 because our society is used to correlating birth mothers with maternity, this right is not always afforded to gestational surrogates without a petition to the court.29 b. varying outcomes between/within states 1. varying outcomes and custody disputes the primary source of confusion amongst parties interested in gestational surrogacy is the variance of surrogacy laws amongst states. often, it can be difficult to predict how a court will rule when issues with a gestational surrogacy arrangement arise. in indiana, it can be especially difficult to predict outcomes .because gestational surrogacy agreements are unenforceable; however, indiana does not forbid surrogacy itself.30 indiana forbids honoring gestational surrogacy agreements because the legislature deems them to be contrary to public policy. 31 indiana attorneys are able to draft agreements as best as they can; however, there is no guarantee as to the result of the situation. 32 outcomes of gestational surrogacy arrangements can be unpredictable in other states as well. 27 tenth annual review, supra note 14, at 878. 28 erin v. podolny, are you my mother?-' removing a gestational surrogate's name from the birth certificate in the name of equal protection, 8 u. md. l. j. race, religion, gender & class 351, 351 (2008) (stating that in the case of in re roberto db., the court ordered that the surrogate's name be removed from the birth certificate and a new certificate be reissued solely in the name of the father). 29 id. at 365. 30 gestational surrogacy program, family beginnings, http:// www.ivfindiana.com/gestational-surrogacy-program.html (last visited aug. 3, 2012). 31 ind. code § 31-20-1-1 (2012). 32 gestational surrogacy program, supra note 30, at 1. 182 vol. 10: 1 gestational surrogacy agreements in indiana in a.g.r. v. d.r.h & s.h., the superior court of new jersey declared the gestational surrogate to be the legal mother of a set of twins that she carried for her brother and his partner.3 3 in that case, the intended parents (a homosexual couple that had a registered civil union in new jersey and had been legally married in california) entered into a gestational surrogacy agreement with the sister of one of the men.3 4 the sperm of one of the partners and a donor egg were used; the gestational surrogate was not genetically related to the child.35 this ruling provided the gestational surrogate with the "right to seek primary custody of the children."36 contrastingly, in maryland, as long as both the intended parents and the gestational surrogate are in agreement, the court will honor the gestational surrogacy agreement.37 however, if the surrogate desires to attempt to establish parental rights, maryland has not necessarily established an 'intent' test to determine parentage, which can be very troublesome for intended parents. 38 these varying laws amongst states create a confusing atmosphere for parents desiring to have a child via gestational surrogacy. the best hope for parents is to consult with attorneys and thoroughly research the surrogacy laws of their state in order to attempt to create the best possible scenario for a positive 3 a.g.r. v. d.r.h., no. fd-09-001838-07 (n.j. super. ct. ch. div. dec. 23, 2009), available at http://www.nytimes.com/packages/pdf/ national/20091231_surrogate.pdf. 34 id. at 2. 35 id. 36 stephanie saul, new jersey judge calls surrogate legal mother of twins, n.y. times, dec. 30, 2009, http://www. nytimes.com/2009/12/31/us/31surrogate.html?_r=1. -in this case, the judge equated the baby m decision with that of his own; eluding to the fact that intended parents have no more merit to their claims for parentage regarding children born to a gestational surrogate than they do for children born to a traditional surrogate. id. if upheld, this decision will drastically change the traditional view that intended parents are more protected in their parenthood status when they are genetically linked to the child. id. 37 bashur, supra note 26, at 182. 38 id. at 183. 2013 183 indiana health law review outcome of the arrangement. 39 additionally, states that do not honor gestational surrogacy agreements often vary from case to case as to how they deal with gestational surrogacy arrangements. for example, some states treat surrogacy arrangements like adoptions, giving the surrogate a period of time (typically seventy-two hours) after the child is born to decide whether or not she wants to keep the child.40 though it is very uncommon for a gestational surrogate to attempt to keep the child, the possibility of a court battle dissuades many intended parents from pursuing a gestational surrogacy arrangement. 41 2. pre -birth parentage orders in some states, courts will issue a pre-birth order that establishes the intended parents as the parents whose names should be placed on the child's birth certificate. 42 for example, new hampshire provides for a pre-birth determination of parentage "which results in the automatic termination of the surrogate's parental rights after 72 hours following delivery; this allows the intended parents' names to be entered on the child's original birth certificate and there is never a reference to the gestational surrogate's 39 the law, the surrogacy experience, http://www. thesurrogacyexperience.com/surrogates.cfm?sc=23&p=97 (last visited aug. 3, 2012). 40 browne c. lewis, three lies and a truth:' adjudicating maternity in surrogacy disputes, 49 u. louisville l. rev. 371, 380 (2011). 41 hel6na ragon6, surrogacy-cultural/legal implications, jrank.org, http://family.jrank.org/pages/1666/surrogacy-culturallegal-implications.html (last visited aug. 3, 2012). 42 the pre-birth parentage order, the surrogacy experience, http://www.thesurrogacyexperience.com/surrogates.cfm?sc=23&p=100 (last visited aug. 3, 2012); us. surrogacy law by state, the surrogacy experience, http://www.thesurrogacyexperience.com/ surrogates.cfm?sc =23&p=99 (last visited aug. 3, 2012) (stating that connecticut, indiana, new jersey, ohio, and pennsylvania are some of the states whose judges will grant pre-birth orders (although usually on an inconsistent basis)). 184 vol. 10:1 gestational surrogacy agreements in indiana name."43 due to the lack of statutory guidance in many states, it can be difficult to predict whether or not a particular court will grant or deny a pre-birth parentage order. 44 the issuance of pre-birth parentage orders can vary state-by-state, "county by county and even on a judge by judge basis."45 however, the correlation some courts make between gestational surrogacy and adoption causes those courts to not issue pre-birth orders due to the mandatory waiting period associated with adoptions. 46 although some pre-birth orders may still be granted, there is not much assurance for the intended parents regarding the outcome of such proceedings until the hearing for the pre-birth order occurs. 4 7 in indiana, pre-birth orders may be granted inconsistently due to the state's refusal to acknowledge gestational surrogacy agreements, 48 which may cause a tumultuous situation for both the intended parents and the gestational surrogate. 49 the reason for this inconsistency is that "indiana currently has no laws that specifically allow or prohibit pre-birth parentage orders."50 in belsito v. clark, an ohio court determined that the intended parents should be acknowledged as the legal and natural parents of an unborn child being carried by a surrogate.5 1 in this case, mr. and mrs. belsito desired to have a child, but mrs. belsito had had a hysterectomy and was unable to conceive; therefore, her sister became the gestational surrogate for the couple. 52 prior to the birth of 43 ford, supra note 6, at 90. 44 us. surrogacy law by state, supra note 42. 45 id. ("in every case where surrogacy is permitted but there is neither a statute nor a ruling from the state's highest court governing the process, the question of pre-birth orders will be determined on a county by county and even on a judge by judge basis. this greatly complicates the issuance of birth certificates in the name(s) of the intended parent(s) and not the name of the surrogate and, if she is married, her husband."). 46 larkey, supra note 20, at 611. 47 id. 48 us. surrogacy law by state, supra note 42. 9 jackson, supra note 25, at 3. 50 id 51 belsito v. clark, 644 n.e.2d 760, 768 (ohio com. pleas 1994). 52 id. at 761. 2013 185 indiana health law review the child, mrs. belsito contacted the hospital and was told that the surrogate's name would be placed on the birth certificate and that, because the surrogate and mr. belsito were not married, the child would be considered illegitimate and listed as "'baby boy clark' and not as 'baby boy belsito."'53 as an issue of first impression, the ohio court entered into a lengthy discussion and eventually determined that biology should determine that the belsitos be considered the legal and natural parents of the child.54 because there was no statutory law regarding gestational surrogacy in ohio, the court's decision was unpredictable by the parties in this scenario.55 although this outcome was good news for the belsitos, it was unclear if the court would have reached the same decision if donor genetic material had been used during the ivf process. the ohio courts answered this question in the case of s.n v. mb. 6 in this case, the intended mother and her fianc6e used a gestational surrogate to carry a child that was created using male and female donor material, meaning that neither of the intended parents or the surrogate would have a genetic link to the child.57 the gestational surrogate became pregnant with twins; however, the twins were born premature and one of them did not survive.5 8 while the determination of maternity was being decided by the courts, the surviving twin was released from the hospital to the surrogate; the surrogate then relinquished day-to-day care to a third party.59 the gestational surrogate refused to comply with the written surrogacy agree-ment and filed a 53 id. at 762. 54 id. at 768. 55 victoria l. fergus, an interpretation of ohio law on maternal status in gestational surrogacy disputes: belsito v. clark, 644 ne.2d 760 (ohio cp summit county 1994), 21 dayton l. rev. 229, 234 (1995) (explaining that the court denied the use of the intent test because it did not acknowledge public policy issues and failed "to recognize the genetic mother's rights."). 56 s.n. v. m.b., 935 n.e.2d 463 (ohio app. 2010). 57 id. at 464-65. 58 id. at 465. 59 id. 186 vol. 10: 1 gestational surrogacy agreements in indiana claim for custody of the child.60 after a long and tumultuous court battle, the court of appeals of ohio, recognizing the validity of the gestational surrogacy agreement, granted custody to the intended parents.6 1 in this case, the intended parents' child was over two years old by the time the courts determined parentage and resolved custody. 62 although this was, in the end, a favorable outcome for the intended parents, the court's reliance on the validity of the gestational surrogacy agreement 63 is unsettling for intended parents in indiana, where such agreements are not recognized. 64 iv. current gestational surrogacy laws and models of other states a. indiana's current gestational surrogacy laws 1. statutory law in indiana in indiana, all surrogacy agreements entered into after 1988 are void.65 this is due to the indiana legislature's determination that enforcement of surrogacy agreements is against public policy.66 the indiana legislature has determined that surrogacy agreements containing the following provisions are against public policy: (1) provide a gamete to conceive a child. (2) become pregnant. (3) consent to undergo or undergo an abortion. (4) undergo medical or psychological treatment or examination. (5) use a substance or engage in activity only in accordance with the demands of another 60 id. 61 id. at 472-73. 62 id. (the child was born on may 15, 2008; however, the court of appeals of ohio did not issue its opinion until june 10, 2010.). 63 id. at 470-73. 64 ind. code § 31-20-1-2 (2012). 65 id. 66 ind. code § 31-20-1-1 (2012). 2013 187 indiana health law review person. (6) waive parental rights or duties to a child. (7) terminate care, custody, or control of a child. (8) consent to a stepparent adoption under ic 31-19 (or ic 31-3-1 before its repeal).67 this statute makes clear the legislature's intent to prevent the recognition of both traditional and gestational surrogacy agreements. many states that render gestational surrogacy agreements void do so because of the belief that "birth mothers are contracting away their parental rights."68 however, there are remedies for this perception: "a gestational carrier should never be presumed to have any parental rights, as the implanted embryo is not genetically related to her."69 as a result of the nullification of surrogacy agreements, it can be difficult to predict the outcomes of gestational surrogacy arrangements in indiana. indiana defines a surrogate agreement as an: agreement that is entered into before the birth of a child . . . that is intended by the parties at the time that the agreement is made to induce the surrogate to relinquish care, custody, and control over the child at birth to any of the following: (1) an intended biological parent of the child . . . (3) two (2) intended biological parents of the child.70 additionally, indiana defines a surrogate as a person who: bears a child that is genetically related to: (1) the party who agrees to bear or bears the child 67 id. 68 ford, supra note 6, at 90 (explaining that in addition to the example of indiana's finding that gestational surrogacy agreements are void, michigan, new york, and other states have also created laws stating the same.). 69 id. 70 ind. code § 31-9-2-127 (2012). 188 vol. 10:1 gestational surrogacy agreements in indiana and an intended biological parent; (2) an intended biological parent and a gamete donor who is not: (a) an intended biological parent; and (b) the spouse of the party who agrees to bear or bears the child; or (3) two (2) intended biological parents of the child.71 the plain language of these statutes indicates that the indiana. legislature has a strong distaste for all forms of surrogacy, including gestational surrogacy. further, indiana courts cannot make custody decisions, or "best interest of the child" decisions, based solely on the existence of a surrogacy agreement. 72 therefore, the indiana statutory scheme provides little security for individuals entering into surrogacy arrangements because, in the event a discrepancy arises, the intent of the parties in creating the agreement will not be used as significant evidence in favor of the gestational surrogate. pre-birth parentage orders may provide some sense of security; however, indiana jurisdictions differ on whether or not they will allow parentage orders because indiana has no specific laws that allow or prohibit them.7 3 the granting of pre-birth parentage orders allows the legal rights regarding the child to "vest immediately upon the child's birth."74 "there is an advantage to pre-birth establishment of parenthood, especially in dealing with control of the child immediately after the birth, removing the child from the hospital, [and] insuring the child."75 these advantages make it well worth the intended parents' efforts to try to obtain the pre-birth determination of parentage because it will allow them to take their child(ren) home from the 71 ind. code § 31-9-2-126 (2012). 72 ind. code § 31-20-1-3 (2012). 73 jackson, supra note 25, at 3. 74 ford, supra note 6, at 88. 75 id. (quoting h. joseph gitlin, surrogacy: illinois becomes surrogacy friendly, gitlin, busche & stetler, http://www. gitlin.com/pages/illinoisbecomessurrogacyfriendly. html (last visited aug. 3, 2012)). 2013 189 indiana health law review hospital, as well as immediately be able to make medical decisions for their child(ren).76 2. case law in re paternity and maternity of infant r. indiana's leading case law regarding the interpretation of gestational surrogacy arrangements is in re paternity and maternity of infant r. 77 in that case, the gestational surrogate, who is the intended mother's sister, and the intended parents entered into a surrogacy agreement.78 all parties involved remained in agreement regarding the desired and intended parents of infant r.79 during the pregnancy, the parties petitioned the court to establish the intended parents as the legal parents of the child.s0 despite their agreements throughout the gestational surrogate's pregnancy, the juvenile court denied the petition to establish maternity stating, "the court finds that indiana law does not permit a non birth mother to establish maternity. indiana law holds the birth mother is the legal maternal mother. the court finds and recommends that the agreed petition to establish paternity and maternity be denied."81 ultimately, the indiana court of appeals reversed and remanded the case to determine the biologic maternity of infant r. to establish legal maternity of the child. 82 the indiana court of appeals called for action by the legislature, noting that: no legislation enacted in this state specifically provides procedurally for the establishment of maternity; it is presumed that a woman who 76 ford, supra note 6, at 88. 77 in re paternity and maternity of infant r., 922 n.e.2d 59 (ind. ct. app. 2010). 78 id. at 60. 82 id. 80 id. 81 i-d 82 id. at 62. 190 vol. 10:1 2013 gestational surrogacy agreements in indiana gives birth to a child is the child's biological mother . . . we are confronted with reproductive technologies not contemplated when our legislature initially sought to provide for the establishment of legal parentage for biological parents . .. it is for the legislature to evaluate and deliberate comprehensive proposals for changes to these statutes.83 in re paternity and maternity of infant r. shows just how complicated the gestational surrogacy/establishment of maternity process can be. the involved parties in that case originally filed to establish paternity and maternity in december 2008.84 maternity was not established until after this decision was issued in february 2010 (after infant r. was over one year old).85 in situations of contested custody, this one-year lapse in determination of maternity could be very detrimental to all parties involved. even in noncontested situations, a one-year lapse in the determination of parentage can take valuable time away from the intended parents and their child(ren). 3. public policy rationale behind indiana's gestational surrogacy la ws a. social mores that cause opposition to gestational surrogacy many argue that gestational surrogates "challenge our most basic ideas about motherhood, and call into question what we've always thought of as an unbreakable bond between mother and child."86 it is this challenge to 83 id.at 61. 84 id. at 60. 85 id. at 62. 86 lorraine ali, the curious lives of surrogates, daily beast (mar. 29, 2008, 10:55 am),http://www.thedailybeast.com/newsweek/ 2008/03/29/the-curious-lives-of-surrogates.html (describing the intricate 191 indiana health law review traditional notions of motherhood and additional social stigmas surrounding surrogacies that cause many to look unfavorably upon gestational surrogacy agreements and those who participate in them.87 many feminists and others who oppose the legitimacy of gestational surrogacy agreements feel that these arrangements may exploit women.8 8 in reality, gestational surrogates are not typically as wealthy as the intended parents; however, they also are rarely poor many are women who embrace a potential income while being able to stay home with their own children instead of working.89 another argument against upholding gestational surrogacy agreements "is the potential problem that a child may have because he or she does not know his or her biological mother, which can be crucial to predicting cancer, heart disease, and other medical conditions."90 although this argument is only valid for gestational surrogacy arrangements using donor genetic material, it does not hold much weight because this argument could also be made social stigmas associated with gestational surrogates and the rigorous process they go through to bear someone else's children). 87 id. (the author describes that the social stigma associated with gestational surrogates has even expanded into pop culture, with movies like "baby mama," in which "a single businesswoman (tina fey) is told by a doctor she is infertile. she hires a working-class gal (amy poehler) to be her surrogate. the client is a savvy, smart and well-to-do healthstore-chain exec while poehler is an unemployed, deceitful wild child who wants easy money. . . . 'i just don't understand how they can think that,' says surrogate gina scanlon of the stereotypes that influenced the film."). 88 elizabeth s. scott, show me the money: making market in forbidden exchange: surrogacy and the politics of commodification, 72 l. & contemp. prob. 109, 138 (2009). 89 id. at 138-39 ("contrary to the claim that surrogacy degrades motherhood and pregnancy, the available evidence suggests that surrogates view themselves as performing a service of great social value for the benefit of others."); ali, supra note 86 (stating that many gestational surrogates are military wives who value their ability to help others start families, while staying home with their own children, while their husbands are on deployment). 90 bashur, supra note 26, at 188. 192 vol. 10:1 gestational surrogacy agreements in indiana against adoption,91 which all fifty states regulate and acknowledge. 92 religious opposition to gestational surrogacy has also been a primary hindrance in the development of prosurrogacy legislation.93 the catholic church, in its ethical and religious directives, has stated, "reproductive technologies that substitute for the marriage act are not consistent with human dignity. just as the marriage act is joined naturally to procreation, so procreation is joined naturally to the marriage act."94 some religious parties have equated the act of surrogacy with adultery.9 5 however, this argument is ill-informed because"[t]he genetic material of the third-party surrogate does not intermingle with the genetics of the intended; therefore, gestational surrogacy should not be equated to adultery."9 6 in a post-baby m society, some societal members are generally skeptical of surrogacy arrangements and feel that they should be prohibited to curb similar conflicts.97 many 91 matthew tieu, oh baby baby' the problem of surrogacy, bioethics res. notes (march 2007), http://www.bioethics.org.au/resources/online%2oarticles/opinion%20 pieces/1901%200h%2obaby%2obaby%2othe%2oproblem%20with%20 surrogacy%20mt.pdf. 92 see child adoption laws, childadoptionlaws.com, http://childadoptionlaws.com (last visited aug. 3, 2012) (listing the relevant state adoption statutes for all fifty states). 93 see generally ford, supra note 6, at 97-98 (describing the religious objections vocalized against surrogacy, including the belief that "[t]he use of third-party genetic material violates the sanctity of the marriage covenant"). 94 united states conference of catholic bishops, ethical and religious directives for catholic health care services 24 (5th ed. 2009), available at http://www.ncbcenter.org/document.doc? id=147. 9 ford, supra note 6, at 97-98. 96 id, at 98. 97 yamamoto, supra note 2, at 109-11 (the baby m case is an infamous case of a traditional surrogate that decided she wanted to keep the baby she had been carrying for the intended parents. because the surrogate was also the genetic mother, it made the determination of motherhood much more complicated.); see in re baby m, 537 a.2d 1227 (n.j. 1988) (baby m is considered to be one of the most infamous and controversial surrogacy cases; however, it should be noted that it 2013 193 indiana health law review fertility clinics and gestational surrogate placement agencies now force intended parents and surrogates to submit to intense physical and psychological screening in order to reduce the risk that a surrogate will become overly attached to the baby during the surrogacy. 98 gestational surrogates are evaluated to determine their ability to not grow overly attached to the child that they will potentially carry; intended parents are also evaluated to determine their intentions will remain intact through-out the process. this is to help ensure that there will be no issues taken to court, as it is unclear how many courts will rule should a dispute arise. contrary to the presumption that many surrogates will feel an unexpected bond with the child they are carrying and seek parentage, most surrogates explain their relationship with the gestating child as an intense, caring babysitting role.99 additionally, surrogates attempt to fight the stigma by justifying their actions via the response, "tell them what that man, woman, or couple went through for years before you stepped in to take their pain away and give them a reason to live." 0 0 many gestational surrogates, or 'carriers' as they often refer to themselves, feel a deep sense of social satisfaction because they are able to perform "a service of great social value for the benefit of others."' 0 ' some women also describe the sensation of enjoying being involved a traditional surrogate, not a gestational surrogate, and thus presents very different issues and ideals than those presented in this note.). 98 yamamoto, supra note 2, at 123-24 ali, supra note 86 (gestational surrogates are evaluated to determine their ability to not grow overly attached to the child that they will potentially carry; intended parents are also evaluated to determine their intentions will remain intact throughout the process. this is to help ensure that there will be no issues taken to court, as it is unclear how many courts will rule should a dispute arise.). 9 scott, supra note 88, at 139. 100 ford, supra note 6, at 84. 101 scott, supra note 88, at 139-40 (citing janice c. ciccarreli & linda j. beckman, navigating rough waters: an overview of psychological aspects of surrogacy, 61 j. soc. issues 21 (2005); carol sanger, developing markets in baby-making: in the matter of baby m 30 harv. j. l. .& gender 67 (2007)). 194 vol. 10:1 2013 gestational surrogacy agreements in indiana pregnant, while not having the desire to have more children of their own. 102 gestational surrogacy is becoming more popular, in part due to a "greater acceptance of the practice" and in part due to significant increases in success rates of fertility clinics practicing ivf.103 the passage of time since the decision of the baby m case has shown that moral panic dissipates over time making the present, rather than the period immediately following the baby m decision, a much more appropriate time for the indiana legislature to address gestational surrogacy arrangements. 10 4 it is time for the indiana legislature, as well as the legislatures of all states that deem gestational surrogacy agreements void, to reevaluate the validity of gestational surrogacy agreements. b. alternative arguments to policy concerns state legislatures often ban gestational surrogacy agreements, or choose to not recognize them, because the legislatures have acknowledged a public policy concern against the "sale" of infants.10 5 however, gestational surrogacy agreements can be honored, and still uphold public policy, by being worded not to allow for the "sale" of 102 ali, supra note 86 (for example, "jennifer cantor, a 34-year-old surgical nurse . . . loves being pregnant. not having children, necessarily-she has one ... and has no plans for another-but just the experience of growing a human being beneath her heart."). 103 id. (for example, the genetics & ivf institute in virginia, the clinic studies for ali's article, advertises a success rate of 70%-90% for gestational surrogacy arrangements result-ing in successful pregnancies. this statistic shows a 40% increase in the past ten years.). 104 scott, supra note 88, at 145-46 ("the passage of time allows the political climate to cool, but it can also serve another useful purpose. an extensive period dedicated to acquiring accurate information and to deliberation provides the opportunity to correct distortions created by availability cascades."). 105 sara k. alexander, who is georgia's mother? gestational surrogacy: a formulation for georgia's legislature, 38 ga. l. rev. 395, 415-16 (2003) (asserting that "'baby-selling"' has been deemed "the most controversial aspect of surrogate mother agreements"). 195 indiana health law review an infant.106 professor richard epstein "notes the term 'commodity' is misused in the surrogacy context . . . in surrogacy arrangements . . . the subjective value of the human involved precludes any useful comparison to a commodity . . . surrogacy contracts are not for resale, they are for a one-of-a-kind creation." 07 in states where gestational surrogacy is allowed, the legislature and courts have viewed the surrogates as "providers of a 'service,' rather than baby-sellers."1 0 8 many who critique gestational surrogacy arrangements do so on the grounds that "birth mothers are contracting away their parental rights."109 however, others argue that: a gestational carrier should never be presumed to have any parental rights, as the implanted embryo is not genetically related to her. this statement is not intended to trivialize the emotional bond formed between a woman and the unborn child she carries, but rather to convey the more significant relation-ship between the genetic parent and the resultant child which the contracting parties intended.110 additionally, because maternity in gestational surrogacy situations should be decided based upon the surrogate's lack 106 id. at 417-19 (stating that gestational surrogacy agreements can reduce the implications of "'selling infants' by only compensating the surrogate for medical expenses, denying pre-birth determinations of parentage, and/or "making the surrogate a 'trustee' of sorts of parental rights"). 107 kevin tuininga, the ethics of surrogacy contracts and nebraska's surrogacy law, 41 creighton l. rev. 185, 194 (2008) ("[tlhe commodification argument is not solid enough to justify more than bare assertions that surrogacy involves the purchasing of women and children."). 108 ohs, supra note 3, at 340 (asserting that viewing gestational surrogates as service providers can create issues when there are differing opinions between the intended parents and the surrogate regarding medical decisions and how she can/should treat/care for her body). 109 ford, supra note 6, at 90. 110 id. 196 vol. 10:1 2013 gestational surrogacy agreements in indiana of "biological ties," the "gestational surrogate does not have the requisite standing to argue that she is the legal mother.""'1 this view of the rights and intentions of the parties may seem crude at first; however, it supports the rationale that gestational surrogates are simply providing a service to the intended parents, not 'selling' their own child, and therefore surrogates should not be entitled to parental rights. additionally, the legislature's careful drafting can minimize policy concerns regarding the potential exploitation of poor women. "the supreme court of california . . . has expressed the view that no hard evidence has shown poor women are exploited in surrogacy contracts in a manner distinguishable from how economic need generally induces needy individuals to accept what some would consider undesirable employment."112 for example, by not allowing additional compensation to be paid to the surrogate, states can reduce many of the risks associated with the exploitation of poor women in gestational surrogacy arrangements.113 the states of washington, maryland, nebraska, and florida are just a few of the states that recognize uncompensated surrogacy agreements but not compensated surrogacy agreements.114 additionally, it is assumed that most intended parents "would hesitate to choose a surrogate mother in such an unstable situation if at all possible.""15 many examples of gestational surrogates, including "a single mom . . . a military spouse . . . and a small-business owner," often defy the stereotypes of the 'type' of woman that becomes a surrogate.116 motives for women who choose to become gestational surrogates may also defy pre-conceived notions and perceptions. for example, some women choose to be surrogates to help close friends or family members give birth to a genetic child; whereas, some choose to do so to raise extra capital for m11 bashur, supra note 26, at 197. 112 tuininga, supra note 107, at 197. 113 ford, supra note 6, at 99. 114 us surrogacy law by state, supra note 42. 115 tuininga, supra note 107, at 195. 116 ali, supra note 86. 197 indiana health law review extravagant family trips or other items which were previously out of reach financially for their families.117 some states, such as illinois, allow for compensation of the surrogate.118 the illinois gestational surrogacy act defines compensation as the "payment of any valuable consideration for services in excess of reasonable medical and ancillary costs.""19 compensating surrogates without exploiting poor women can be done by establishing requirements such as minimum wage earnings of the surrogate, placing a modest cap on the amount of compensation, or enacting other reasonable stipulations.120 more often than not, however, states do not allow for compensation beyond expenses for gestational surrogates to be a part of the gestational surrogacy agreement.121 although there are public policy concerns regarding gestational surrogacy agreements, allowing those who enter into these arrangements to experience the joy of parenthood by guaranteeing the enforcement of their contracts should outweigh these seemingly archaic policy concerns. a validation of surrogacy agreements by a court would "have the effect of vesting the parental rights with the intending parents even before the baby is conceived . . . [this] could eliminate some of [the state's] statutory problems."122 117 id. us 750 ill. comp. stat. 47/25(a)(4) (2012); see also ford, supra note 6, at 88 (stating that illinois and utah, as of 2008, allowed for compensation of gestational surrogates). 119 750 ill. comp. stat. 47/10 (2012). 120 tuininga, supra note 107, at 195 (states can pass legislation "that surrogates must possess financial means above a certain threshold in order for courts to enforce the contract. . . . [liegislatures could criminalize arrangements with surrogates possessing resource limits below a designated level. . . . virginia and new hampshire already require pre-commencement court approval of surrogacy contracts." this pre-approval would help to ensure that a surrogate's financial records meet the requisite levels.). 121 surrogacy laws by state, the select surrogate, http://www. selectsurrogate.com/surrogacy-laws-by-state.html (last visited aug. 3, 2012). 122 alexander, supra note 105, at 425-26 (statutory problems would be eliminated because the "parental rights are technically never surrendered. the surrogate cannot be said to be relinquishing parental 198 vol. 10:1 gestational surrogacy agreements in indiana b. florida's recognition and strict regulation of gestational surrogacy the state of florida has passed legislation honoring gestational surrogacy agreements and regulating the conditions in which they may take place.123 while honoring these agreements, florida also places many restrictions and requirements on the conditions of the gestational surrogacy agreements, making it difficult for many intended parents in florida to comply with the statute.124 in doing so, the florida legislature has provided certain 'safe-guards' against some of the major public policy concerns with gestational surrogacy.125 the florida statute states, "[pirior to engaging in gestational surrogacy, a binding and enforceable gestational surrogacy contract shall be made between the commissioning couple and the gestational surrogate."126 additionally, the surrogate and intended parents must be at least eighteen years old.127 couples may only commission a gestational surrogacy arrangement if the mother is unable to carry the child herself.128 florida also rights in return for consideration ('baby-selling') because she never gains parental rights during the process. furthermore, the rights of the surrogate are protected by the stringent requirement that the contract be entered into voluntarily."). 123 see fla. stat. § 742.15 (2012). 124 see generally id. (the statute states, among other requirements, that: the intended mother must not be physically able to carry the child herself, the surrogate will make all medical decisions regarding pregnancy management, the surrogate cannot be compensated beyond pregnancy related expenses, and the surrogate must agree to assume parental rights of the child if "neither member of the commissioning couple is the genetic parent of the child."). 125 see id. 126 id. 127 id. 128 id. (florida law reserves the option for gestational surrogacy to mothers "who cannot physically gestate a pregnancy to term; [or situations in which] the gestation will cause a risk to the physical health of the commissioning mother; or the gestation will cause a risk to the health of the fetus."). 2013 199 indiana health law review requires that the commissioning parents be married.129 florida requires a "determination of parentage" within three days of birth.130 however, florida also requires that one of the intended parents be biologically related to the child in order to assert parenthood after the birth of the child.' 3 this requirement prohibits intended parents who are both infertile from participating in gestational surrogacy. additionally, the birth mother's name is initially placed on the birth certificate until the court clerk prepares a certified statement to issue a new birth certificate within thirty days of the child's birth.132 not until then is the biological/intended mother's name listed on the child's birth certificate.133 while this process allows intended parents to feel secure in the outcome of their gestational surrogacy agreement, it still puts many stipulations on both the surrogate and intended parents.134 these limitations appear to prohibit single individuals, unmarried couples, and homosexuals from participating in gestational surrogacy. additionally, intended parents must still wait until after the child is born to establish parentage of the child and have their names placed on the child's birth certificate.135 this delay in establishment of parentage may prevent intended parents from taking their child(ren) home from the hospital after birth and making initial medical decisions regarding the child's health.136 c illinois's welcoming gestational surrogacy laws illinois passed the gestational surrogacy act in 2004, providing intended parents with the security of knowing that a child conceived via ivf and gestated by a surrogate 129 see id. (limiting the option of gestational surrogacy only for heterosexual couples). 130 fla. stat. § 742.16 (2012). 131 id. 132 id. 133 see id. 134 see § 742.15. 135 § 742.16. 136 ford, supra note 6, at 88. 200 vol. 10:1 gestational surrogacy agreements in indiana will automatically become their legal child at birth.137 intended parents are given security in their future status as legal parents, knowing they will have sole custody of the child immediately after the child is born.138 parentage can even be established prior to the birth of the child if both the intended parents and the gestational surrogate are represented by separate legal counsel and agree regarding the satisfaction of contract requirements." 13 9 if the gestational surrogacy agreement is not valid for some reason, the court "shall deter-mine parentage based on evidence of the parties' intent."140 this provides additional security for the intended parents in the event that their agreement with the gestational surrogate is not recognized. "illinois has some of the most comprehensive laws addressing gestational surrogacy in the country and should be adopted as a model by other states wishing to enact legislation allowing gestational surrogacy." 141 although illinois has many requirements, these procedures help to make the gestational surrogacy arrangement secure and predictable for all involved parties. illinois requires that the gestational surrogacy agreement be in writing and entered into prior to ivf.142 additionally, the gestational surrogate must be at least twenty-one years old, must have previously given birth to at least one child, and must have completed medical and mental health evaluations. 143 "[elach of the gestational surrogate and the intended parent or parents shall have been represented by separate counsel in all matters concerning the gestational surrogacy and the gestational surrogacy con-tract."144 the surrogate must also have health insurance; however, the intended parents are 137 scott, supra note 88, at 109 (the gestational surrogacy act lists numerous requirements to make the arrangement enforceable. notably, it "passed unanimously in both houses of the legislature."). 138 750 ill. comp. stat. 47/15 (2012); 750 ill. comp. stat. 47/10 (2012). 139 750 ill. comp. stat. 47/35 (2012). 140 750 ill. comp. stat. 47/25(e) (2012). 141 ford, supra note 6, at 101. 142 750 ill. comp. stat. 47/25 (2012). 143 750 ill. comp. stat. 47/20(a) (2012). 144 750 ill. comp. stat. 47/25(b)(3) (2012). 2013 201 indiana health law review permitted to pay for the health coverage during the pregnancy and up to eight weeks after birth.145 illinois's statute allows for fair compensation to the gestational surrogate.146 if the agreement allows for compensation of the surrogate, "the compensation shall have been placed in escrow with an independent escrow agent prior to the gestational surrogate's commencement of any medical procedure."147 it should be noted, however, that illinois's statute also states that "there shall be no specific performance remedy available for a breach by the gestational surrogate of a gestational surrogacy contract term that requires her to be impregnated."148 this requirement prevents the intended parents from forcing a surrogate to be impregnated. as an additional safeguard for the parties, illinois courts shall presume enforceability of gestational surrogacy agreements.149 illinois law also states that there are particular provisions that must be included in the gestational surrogacy agreements: the written consent of the surrogate, the consent of her spouse (if married), the right to choose her own physician after consulting with commissioning parents, and the consent of the intended parent(s) to accept custody and "assume sole responsibility" immediately following the birth of the child. 150 though these requirements seem stringent, the end result is that the intended parents' names can be on the child's birth certificate without special court authorization as long as a "voluntary acknowledgement of parentage" exists in accordance with the qualifications set forth by the illinois legislature.15 145 750 ill. comp. stat. 47/20(a)(6) (2012). 146 750 ill. comp. stat. 47/25(a)(4) (2012). 147 750 ill. comp. stat. 47/25(b)(4) (2012). 148 750 ill. comp. stat. 47/50 (2012). 149 750 ill. comp. stat. 47/25(d) (2012). 150 750 ill. comp. stat. 47/25 (2012). 151 750 ill. comp. stat. 45/6 (2012) (in order to establish the intended parent-child relationship, the gestational surrogate must certify that she (and her husband, if she has one) is/are not biologically related to the child, the intended mother must certify that she or an egg donor are the biological mother of the child, the intended father must 202 vol. 10:1 gestational surrogacy agreements in indiana in addition to the safeguards provided to the parties, hospitals and physicians also face decreased liability under illinois's gestational surrogacy laws. this is due to the reduced risk of later facing a lawsuit by either the intended parents or surrogate based on the results of the hospital's decisions in handling the birth certificate, parental rights, and/ or release of the child. illinois's system also decreases confusion by having a standard procedure in which gestational surrogacy agreements are acknowledged and handled by hospitals. 152 hospitals know the requirements of the gestational surrogacy act and are easily able to determine if the required provisions have been met or not. 153 ultimately, increased patient satisfaction by all parties is achievable due to the ability to alleviate the stress and anxiety that often come with the uncertainties of gestational surrogacy and the rights of the intended parents as the child's legal parents. v. benefits of adopting illinois-style legislation a. intended parents would have security in the outcomes of their arrangements illinois, in having "some of the most comprehensive laws addressing gestational surrogacy in the country," is often used as a model for other states desiring to implement similar gestational surrogacy regulations. 154 one of the certify that he or a sperm donor are the biological father of the child, a physician must certify that the child is biologically related to at least one of the intended parents, the parties' attorneys must certify that they have entered into a gestational surrogacy agreement, and all of these certifications must be witnessed by two adults that are not party to any aspect of the agreement.). 152 750 ill. comp. stat. 47/15 (as long as the surrogate and intended parents "satisfy the eligibility requirements set forth in" 750 illinois compiled statutes 47/20(a)-(b), and "pursuant to a gestational surrogacy contract meeting the requirements set forth in" 750 illinois compiled statutes 47/25, the intended mother and/or father will be the child's legal parents "immediately upon the birth of the child.". 153 see id. 154 ford, supra note 6, at 101. 2013 203 indiana health law review obvious benefits of adopting an illinois-style gestational surrogacy policy in indiana is the decreased worry that parties would face regarding the court's interpretation of their intentions. very few states have addressed gestational surrogacy either through enacted statutes or case law. this often leaves parties to a gestational surrogacy agreement in uncharted territory, which could put them in a situation with unintended consequences . . . therefore, each state's legislature should enact gestational surrogacy statutes which provide clear guidelines for intended parents and surrogates. 5 5 furthermore, it would be possible for indiana to allow gestational surrogacy while still prohibiting traditional surrogacy arrangements. 156 if the legislature regulates gestational surrogacy agreements, indiana would be able to provide security to intended parents who have invested significant amounts of money towards their last chance at raising a genetic child. with the average cost of ivf totaling around $14,500 per round, in addition to costs paid to the surrogate and unpredictable legal fees, the cost for a couple to have a genetic child via gestational surrogacy can easily range between $25,000 and $75,000.157 in addition to the devastating result of losing a child through a gestational surrogacy dispute, intended parents may also lose significant amounts of money. this tumultuous scenario in a state that does not honor gestational surrogacy agreements has the potential to create an avenue for individuals to exploit the desires of intended parents and extort money from them while posing as a gestational 155 id. at 86. 156 brittnay m. mcmahon, the science behind surrogacy: why new york should rethink its surrogacy contracts laws, 21 alb. l. j. scl. & tech. 359, 372 (2011). 157 ford, supra note 6, at 85. 204 vol. 10-1 gestational surrogacy agreements in indiana surrogate.15 8 the acknowledgement and regulation of gestational surrogacy agreements in indiana would eliminate these potential scenarios by legally binding both parties to the agreement. legal fees for the intended parents would be decreased because attorneys would know exactly how to create a binding agreement; thus, fewer legal expenses would occur by not having to attempt to navigate the unpredictable gestational surrogacy system in indiana.159 similarly, legal fees of providers would likely decrease because of the certainty regarding the proper custody of the child. "unchartered, uncertain legal territory would not need to be forged each time a gestational surrogacy controversy or case arises; thus, legal expenses for intended parents would be minimized."160 b. the intent of the parties would be a determining factor in declaration of parentage by acknowledging the intent required to enter into an agreement, the legislature would be showing that intent is a superior determination of parentage rather than other determining factors. this is a logical conclusion because "the procreation of the child resulted from 'a medical procedure [that] was initiated and consented to by intended 158 see generally fed. bureau of investigation, surrogacy scam played on emotions of vulnerable victims (sept. 13, 2011), http://www.fbi.gov/news/stories/201 1/september/surrogacy_091311/ surrogacy_091311 (this scam consisted of three women, two attorneys and a surrogacy facilitator, who defrauded families for over $100,000$150,000 each. by lying to intended parents, surrogates, and the california court, these women sent surrogates to eastern europe to be impregnated by donor material. they then would wait until late in the pregnancy and contact potential intended parents to ask them to take over surrogacy arrangement that could not be fulfilled by the prior intended parents. in doing so, the scammers lied to the intended parents, surrogates, and the california court. "the scam was uncovered when one of the surrogates, nearly seven months pregnant, was worried that parents hadn't been found for the baby she was carrying. she contacted a lawyer, who then contacted the fbi's san diego office."). 159 ford, supra note 6, at 97. 160 id. 2013 205 indiana health law review parents."' 16' conversely, using traditional factors, such as genetics or gestation, may have unintended consequences. for example, using biology as the sole determining factor of parenthood may discourage intended parents from using donor eggs or sperm for gestational surrogacy arrangements. 162 additionally, using gestation as the sole deter-mining factor would allow surrogates to decide to keep the child and would, as a result, promote the extortion of money from intended parents that are desperately seeking a child.163 therefore, in addition to illinois, other states have decided to focus the outcome of surrogacy cases on the intention of the parties instead of biology or gestation. 164 using the intention test helps to protect intended parents who used donor genetic material for the ivf process. by using donor material, there is no risk of the donor having a claim to parentage, only the surrogate. donors have no claim to, or obligation of, parental rights as long as they enter into an agreement with the intended parents surrendering their rights.165 this relinquishment of donor rights and assumption of parental rights by the intended parents allows the intended parents to not have to worry about the legal ramifications of using a donor's genetic material to be implanted in the gestational surrogate.166 161 bashur, supra note 26, at 170 (citing in re marriage of buzzanca, 72 cal. rptr. 2d 280, 293 (cal. ct. app. 1998). 162 lewis, supra note 40, at 395. 163 id. at 398-99. 164 bashur, supra note 26, at 168 (describing the outcome of johnson v. calvert, 5 cal.4th 84 (cal. 1993) by stating, "california was the first state to determine the outcome of surrogacy cases by focusing on intention, rather than on biology or gestation alone."). 165 jeremy j. richey, a troublesome good idea: an analysis of the illinois gestational surrogacy act, 30 s. ill. u. l.j. 169, 177 (2005). 166 id. ("the donor will have a duty to support a child 'only if he or she fails to enter into a legal agreement with the intended parent[s] ... in which the intended parent[s] . . . agree to assume all rights and responsibilities for any resulting child, and the gamete donor relinquishes his or her rights to any gametes, resulting embryos, or children."' (quoting 750 ill. comp. stat. 47/30 (2012))). 206 vol. 10: 1 gestational surrogacy agreements in indiana c. pre-birth determinations ofparentage would be predictable and readily available if gestational surrogacy agreements were recognized, parties would be able to request a determination of parentage prior to the birth of the child and, therefore, be assured of the outcome, provided that the agreement provisions had been honored by the parties. 167 because gestational surrogacy is not a technology that will dissipate in popularity anytime soon, it is imperative that intended parents and gestational surrogates alike are able to have certainty regarding the outcomes of their arrangements.1 6 8 in an illinois-style system, the intended parents are the legal parents of the child upon birth, provided that all parties involved comply with the statutory provisions, and the child will be considered the legitimate child of the intended parents.169 d. surrogates will be confident in the outcomes of their arrangements gestational surrogacy statutes emulating illinois's also protect the surrogate from being "stuck" with a child that she did not choose to have because the "intended parents will still have a duty to support the child financially even if they breach the contract." 70 furthermore, challenges to rights of parentage can only be made within the first year of the child's life; after this point neither party will have to worry about any potential changes in their parenting status, providing all parties with additional security in the permanence of their agreement.171 167 carla spivack, supplement, the law of surrogate motherhood in the united states, 58 am. j. comp. l. 97, 107 (2010) (describing the uncertainty of outcomes of determinations of parentage when the gestational surrogacy agreement is not acknowledged). 168 id. at 114. 169 richey, supra note 165, at 173-74. 170 id. at 174. 171 id. at 178. 2013 207 indiana health law review e. hospitals and physicians will be confident in their patient care decisions under an illinois-style system, the hospital and obstetrics physicians can simply place the intended parents' names on the birth certificate so long as all components of the gestational surrogacy act have been met. 172 this eliminates any potential liability on behalf of the physicians and hospital by having to make a judgment call regarding which parent(s) name can go on the birth certificate and who is allowed to take the child home. without this safety net of firm gestational surrogacy legislation, hospitals open themselves up to lawsuits from intended parents andlor gestational surrogates regarding the outcomes of their decisions regarding the child(ren). for example, in pennsylvania, intended parents filed suit against the birthing hospital of their triplets, "stating that it conspired with the surrogate to prevent [the intended parents] from seeing [their] children at the hospital."173 in this case, the hospital released the triplets to return home with the surrogate, which began a custody battle between the surrogate and the intended parents. 174 if pennsylvania had enacted legislation regarding the validity of gestational surrogacy agreements, the hospital would have known exactly how to act and could have avoided this lawsuit entirely. vi. best practice suggestions for physicians and hospitals until indiana regulates and recognizes gestational surrogacy agreements because indiana's gestational surrogacy laws do not 172 jackson, supra note 25, at 4. 173 media watch archive, the org. of parents through surrogacy, http://www.opts.com/mediawatcharchive.htm (last visited aug. 17, 2012). 174 andrew vorzimer, lawsuit against hospital over surrogate delivery of triplets allowed to continue, the spin doctor (sept. 24, 2009), http://www.eggdonor.com/blog/2009/09/24/lawsuit-againsthospital-over-surrogate-delivery-of-triplets-allowed-to-continue. 208 vol. 10:1 gestational surrogacy agreements in indiana provide procedures and regulations for medical providers to follow, it is difficult for hospitals and physicians to know what to do once the child(ren) of gestational surrogacy are born. if the parties have obtained a pre-birth parentage order prior to the birth of the baby, that order should be honored by the hospital in determining the names of the parents for the child's birth certificate. 7 5 if the parties have not obtained a pre-birth parentage order, and there is time to do so before the birth of the baby, it would be prudent for the parties to seek a determination of parentage by the court; however, various jurisdictions within indiana differ on the approval or denial of these orders. 176 if a pre-birth parentage order cannot be obtained, the surrogate's name should be placed on the birth certificate and the intended mother will have to undergo an adoption hearing in order to become the legal mother of the child. 177 while this outcome is not desirable for the surrogate or the intended parents, it is the best way for the hospital to prevent a lawsuit, as it is the only way to accurately follow indiana's surrogacy laws. additionally, the child(ren) should be sent home with the named parents on the birth certificate, whether that is the surrogate or the intended parents. once the surrogate leaves the hospital, she may transfer the child over to the intended parents, if she so desires. if the surrogate desires to try to gain custody of the child, the hospital should remain removed from the situation and leave the parties to deal with the issues in court. vii. conclusion the most reliable way to ensure that the scope of the parties' rights in a gestational surrogacy arrangement are entirely realized is for the legislature to fully address these issues.178 it is difficult for hospitals and physicians to know how to respond to gestational surrogacy situations when 175 jackson, supra note 25, at 3. 176 id. 177 id. 1783 ohs, supra note 3, at 341-42. 2013 209 indiana health law review different legal outcomes can occur each time. in order to alleviate confusion, stress, and even litigation from the gestational surrogacy process, indiana should adopt an illinois-style policy regarding its acknowledgement of gestational surrogacy arrangements. by regulating the circumstances in which gestational surrogacy arrangements can be legitimized, indiana will have more control over the surrogacy realm than they do now by simply not acknowledging these agreements. furthermore, in adopting a regulatory scheme, indiana will prevent the anguish its residents face when their arrangements have an unanticipated ending; additionally, it will prevent the exploitation of particular populations that may be more susceptible to becoming gestational surrogates. because indiana citizens still enter into gestational surrogacy arrangements; therefore, it is advantageous for the state to regulate the industry rather than ignore it completely. until indiana adopts a more specific, welcoming policy on gestational surrogacy, hospitals must be acutely aware of the ramifications of their actions should a party to the arrangement decide to change his/her mind. by honoring pre-birth determination orders, suggesting that parties obtain them before birth, and recognizing the surrogate as the legal mother until a court order states otherwise, hospitals and physicians can take the best possible steps to eliminate their risk in these scenarios. it is best for the hospital to remain as far removed from the legal issues surrounding gestational surrogacy as possible. by placing custody with whichever parent(s) names are listed on the birth certificate, and allowing the parties to work out the details amongst themselves, indiana hospitals are reducing their legal risk. however, this outcome may not be desirable to the gestational surrogate and/or the intended pdrents. although it is a difficult decision for the hospital to make, particularly relating to controversial issues such as these, it is better for the hospital to base its decision on the law than on patient satisfaction. until the legislature creates an adequate policy honoring gestational surrogacy agreements, physicians and hospitals should follow these recommendations. 210 vol. 10: 1 indiana iieaith law review volumes 2011 issue 1 mcdonald-merrill-ketcham memorial award for excellence in law and medicine history and recipients financial conflicts of interest in academic medicine: whence they came, where they went articles certification and meaningful use: reframing adoption of electronic health records as a quality imperative direct-to-consumer advertising of prescription pharmaceuticals, the learned intermediary doctrine, and fiduciary duties snatching confusion from the jaws of clarity: the puzzling evolution of the discovery rule vis-a-vis indiana's medical malpractice statute of limitations notes if addiction is a mental disease, let's start treating it like one: an additional recommendation for the indiana general assembly's prenatal substance abuse commission the case for state mandatory assignment of benefits legislation when the physician says you have to get the shot, but mommy says no: the cases oftaige mueller and daniel hauser, and how the state may force parents to accept unwanted medical treatment for their children working the system: should patients in need of a.n,organ transplant be able to join multiple waitlists? david kom, md. nicolas p. terry heather harrell neal f. eggeson, jr. matthew derringer elliott mckinnis zach williams chad j. wilson indiana university school of law indianapolis iupui indiana health law review volume 8 2010-2011 editor-in-chief melissa l. stuart, m.s. executive managing editor bobby a. courtney, m.a. executive production editors matthew derringer paul jansen executive business editor katie miller note development editors elizabeth eicbholtz lucasmlsna allison neil deyoung vijaypatel chad wilson, d.p.t. erin albert, m.b.a., pharmd alexander berger andrew breck ashley brian lesley brown courtney campbell kate cook brienne delaney kyle fairchild kyle johnson macon jones christopher kacarab articles editors jennifer cooper kristin mccreary andrea white zach williams members faculty advisors executive notes editor amy e. halsey executive articles editor roxana bell executive symposium editor dennis mullen associate editors john brown kelly earls alex krouse julie m. mahomed amber malcolm leeann simpkins beth pirro chris serak kate shelby joel d. swider ash lee talley amy tate, m.s.w. ellen winternheimer lance worland david orentlicher (chair) eleanor d. kinney (co-chair) robert a. katz emily morris miriam murphy (research liaison) indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, 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and dean's fellow. b.a., the university of the west indies; j.d., columbia university school of law; ll.m., new york university school of law. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. chestek, clinical associate professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law. daniel h. cole, r. bruce townsend professor of law. a.b., occidental college; a.m., university of chicago; j.d., lewis and clark law school; j.s.m., j.s.d., stanford law school. jeffreyo. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. eric dannenmaier, associate professor of law and dean's fellow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st, oxford university. james d. dimitri, clinical professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifer a. drobac, professor of law and 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john lawrence hill, professor of law; adjunct professor of philosophy and johns. grimes fellow. b.a., northern lllinois university; j.d., ph.d., georgetown university. linda kelly hill, m. dale palmer professor of law. b.a., j.d., university of virginia. max huffman, associate professor of law and dean's fellow. b.a., cornell university, j.d., university of chicago college of law. lawrence a. jegen, iii, thomas f. sheehan professor of tax law and policy. a.b., beloit college; j.d., m.b.a., the university ofmichigan; ll.m., new york university school of law. robert a. katz, professor of law and johns. grimes fellow. a.b., harvard college; j.d., university of chicago law school. eleanor d. kinney, hall render professor of law, co-director of the williams. and christine s. hall center for law and health. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university ofnorth carolina. andrew r. klein, paul e. beam professor of law; chief of staff, office of the chancellor of indiana university-purdue university-indianapolis. b.a., university of wisconsin; j.d., emory university school oflaw. norman lefstein, professor of law and dean emeritus. ll.b., university oflllinois college of law; ll.m., georgetown university law school. maria p ab6n l6pez, professor of law and dean's fellow. b.a., princeton university; j.d., university of pennsylvania law school. gerard n. maguocca, professor of law; co-director, chinese law summer program and johns. grimes fellow. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor of law. b.s., j.d., university oflllinois. deborah mcgregor, clinical professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law school. susanah m. mead, professor of law. b.a., smith college; j.d., indiana university school of law-indianapolis. emily morris, associate professor of law and dean's fellow. a.b., harvard university, j.d., university of michigan law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. david oreniucher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. a.b., brandeis university; j.d., m.d., harvard college. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, associate professor of law and dean's fellow. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. michael j. pms, associate professor of law; dean's fellow and johns. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. peter a. prescoti, associate professor of law. b.a., augustana college; m.s., the university of chicago; m.p.a., the university oftexas at austin; j.d., the university of houston law center. fran quigley, visiting professor of law. b.a., hanover college; m.a., indiana university; j.d., indiana university school of law-indianapolis. fwrence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. rulitenberg, professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university school of law-indianapolis. joel m. schumm, clinical professor of law and director, judicial externship program. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university school of law-indianapolis. carlton m waterhouse, associate professor of law and dean's fellow. b.s., pennsylvania state university; j.d., howard university school of law; mt.s., emory university, chandler school of theology; ph.d., emory university. frances watson, clinical professor of law. b.s., ball state university; j.d., indiana university school of law-indianapolis. lwyd t. wilson, jr., professor of law and co-director, chinese law summer program. b.a., wabash college; m.a., duke university; j.d., indiana university school of law-bloomington. mary t. wolf, clinical professor of law and director of clinical programs and externships. b.a., saint xavier college; j.d., university oflowa college of law. r. george wright, lawrence a. jegen ill professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university school of law-indianapolis. emeriti faculty 'ihomas b. allington, professor of law emeritus. b.s., j.d., university of nebraska; ll.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, ill, professor of law emeritus and director of the law library emeritus. a.b., j.d., m.a.l.s., the university of michigan. clyde liarrison crockett, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. f alender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university school of law-indianapolis. david a. funk, professor of law emeritu$. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school of law. harow greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of law emeritus. a.b., juniata college; j.d., george washington university law school. william f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. william hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. william andrew kerr, professor of law emeritus. a.b., west university; b.s., duke university; j.d., ll.m., harvard law school. william e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. ronaw w. polston, professor of law emeritus. b.s., eastern lllinois university; ll.b., university oflllinois college of law. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james w. torke, carl m gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick white, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. lawrence p. wilkins, william r. neale professor of law emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., university oftexas school of law. law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. debra denslaw, reference librarian. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school oflaw. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, assistant director for technical services. a.b., taylor university; m.l.s., indiana university. catherine lemmer, head of information services. b.a., lawrence university; j.d., university of wisconsin; m.s., university oflllinois. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. steven r. miller, reference librarian. b.s., lebanon valley college of pennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh, serials/acquisitions librarian. b.a., national university oflran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyosm otsu, automated services and media librarian. a.a., parkland college; a.b., m.s., c.a.s., university of illinois. indiana health law review volumes issue 1 table of contents mcdonald-merrill-ketcham memorial award for excellence in law and medicine history .............................................................................................................. . recipients.......................................................................................................... iii financial conflicts oflnterest in academic medicine: whence they came, where they went.. ................ ................................... david korn, md. 1 articles certification and meaningful use: reftaming adoption of electronic health records as a quality imperative ................................. nicolas p. terry 43 direct-to-consumer advertising of prescription pharmaceuticals, the learned intermediacy doctrine, and fiduciary duties ...... heather harrell 69 snatching confusion from the jaws of clarity: the puzzling evolution of the discovery rule vis-a-vis indiana's medical malpractice statute oflimitations ....................................................... neal f. eggeson, jr. 95 notes if addiction is a mental disease, let's start treating it like one: an additional recommendation for the indiana general assembly's prenatal substance abuse commission .............................. matthew derringer 141 the case for state mandatory assignment of benefits legislation ................................................................................................ elliott mckinnis 171 when the physician says you have to get the shot, but mommy says no: the cases oftaige mueller and daniel hauser, and how the state may force parents to accept unwanted medical treatment for their children ...................................... zach williams 199 working the system: should patients in need of an organ transplant be able to join multiple waitlists? ....................... chad j. wilson 229 2011 health outcomes metrics and the role of financial derivative instruments in the health care industry health outcomes metrics and the role of financial derivative instruments in the health care industry efthimios parasidis' introduction ............................... ...... 447 i. health outcomes metrics ................. ..... 450 ii. health outcomes-based financial derivative instruments .............................. .... 459 iii. conclusion ...................................... 465 introduction despite a culture of innovation, the u.s. health care system has been markedly deficient in its implementation of information technology (it).1 although recent initiatives have endeavored to remedy this shortcoming, 2 fragmentation, high costs, information asymmetries, and * assistant professor of law and public health; moritz college of law, college of public health; the ohio state university. i presented this work at a symposium titled imagining the next quarter century of health care law, which was held at the mckinney school of law at indiana university, and am grateful for discussions with conference panelists and attendees. i thank miriam cherry, caleb desrosiers, gerasimos petratos, and javaid zafar for insightful comments on drafts of this work. a special thanks to the members of the indiana health lawreview for their editorial assistance and for organizing a wonderful symposium. 1 see gary j. young, multistakeholder regional collaboratives have been key drivers of public reporting, but now face challenges, 31 health affairs 578, 582 (march 2012); david blumenthal & marilyn tavenner, the 'meaningful use" regulation for electronic health records, 363 new eng. j. med. 501, 501 (2010); carolyn m. clancy et al., investing in health information infrastructure: can it help achieve health reform?, 28 health aff. 478, 478-479 (2009); ashish k. jha et al., use of electronic health records in us. hospitals, 360 new eng. j. med. 1628 (2009). 2 see efthimios parasidis, patients over politics: addressing legislative failure in the regulation of medical products, 2011 wisc. l. rev. 929, 962-71 (discussing public and private initiatives that support health it). indiana health law review evolving regulatory guidance have delayed meaningful adoption of health it.3 at the same time, health it has been heralded as a panacea that will help stakeholders attain the aspirational goals of reducing health care costs and improving health outcomes.4 while the extent to which existing platforms achieve these goals is debatable, there is little doubt that health it will play an indispensible role for stakeholders throughout the health care industry. in line with the symposium theme of envisioning the next quarter century of health care law, this essay explores emerging issues in health it with a focus on health outcomes metrics and the role of financial derivative instruments in the health care industry. i begin by examining how aggregated patient data can be utilized to create outcomes-based measures such as health outcomes indices (hois). hois integrate multiple sources of realworld patient data to create metrics that timely and accurately measure the burden of disease, track health status, or evaluate health system performance. by accurately capturing and measuring patient outcomes over time, hois endeavor to provide stakeholders with a valuable tool with which to measure, assess, and predict health outcomes at the population level. independent validation of hois as accurate barometers of patient outcomes will permit use of the metrics for a variety of purposes related to health economics, public health policy, and health care management. one promising avenue relates to hoi-based financial derivative 3 see young, supra note 1, at 582-83; michael c. christensen & dahlia remier, information and communications technology in us. health care: why is adoption so slow and is slower better, 34 j. health politics, policy & l. 1011, 1014-15 (2009); james w. henderson, health economics and policy 81-89 (2009); steven h. woolf et al., promoting informed choice: transforming health care to dispense knowledge for decision making, 143 ann. intern. med. 293, 293 (2005), available at https://www.ilr.cornell.edu/healthcare/articles/ upload/promoting-informed-choice-woolf.pdf. 4 see generally david w. bates, the effects of health information technology on inpatient care, 169 archives internal med. 105 (2009); julia adler-milstein et al., us. regional health information organizations: progress and challenges, 28 health aff. 483 (2009); jha et al., supra note 1. 448 vol. 10: 2 health information technology instruments. hoi-based derivatives aim to provide public and private stakeholders with a dynamic opportunity with which to manage investments, capture value movements of assets, prioritize expenditures, and hedge risk. a health it platform that provides outcomes-based clinical decision support and applies a financial derivatives model to mitigate risk facilitates evidence-based management for both public and private stakeholders. data captured by health it platforms, if shared in a transparent and responsible fashion, could revolutionize both the healthcare and financial markets by improving the quality of care, reducing waste, and contributing to market efficiencies. achieving these goals requires an ability to access robust data and a mechanism for translating the data into meaningful metrics. insofar as recent legislative initiatives, including the patient protection and affordable care act (ppaca) and the health information technology for economic and clinical health (hitech) act,5 increase the demand for health it and outcomes-based metrics, this discussion is both timely and prudent. for example, new regulations governing medical loss ratios place a cap on non-medical expenditures, but exclude from the calculation any activity that improves health care quality.6 accountable care organizations (acos) are designed to use evidence-based approaches to improving the quality of care,7 while meaningful use requirements are structured to reward providers who use health it to improve the process of care 5 patient protection and affordable care act, pub. l. 111-148 (march 23, 2010); american recovery and reinvestment act of 2009, pub. l. 111-5, title xiii-iv (feb. 17, 2009). 6 see u.s. gov't accountability office, gao-11-711, private health insurance: early experiences implementing new medical loss ratio requirements, at 5-6 (2011) [hereinafter 2011 gao report]. activities that improve health care quality "include activities designed to increase the likelihood of desired health outcomes in ways that can be objectively measured." id. at 6. 7 see, e.g., thomas l. greaney, accountable care organi-zationsthe fork in the road, 364 new eng. j. med. el(1) (2011). 2013 449 indiana health law review and patient outcomes.8 the office of the national coordinator for health information technology, 9 along with the patient centered outcomes research institute (pcori), are charged with using health outcomes research and health it to improve the quality of health care by promoting and facilitating evidence-based medicine. insofar as each of these areas stands to benefit from hois and hoibased derivatives, contemplating potential uses informs contemporary discussion of scientific, regulatory, and bioethical concerns. i. health outcomes metrics population-level health status metrics have been in existence for no less than five decades. 10 while a number of current indicators provide valuable information for specific aspects of the health care industry, there is no widely accepted metric that measures the burden of disease over time.11 this is problematic, since providers tailor treatment plans and conduct therapeutic interventions based on suspected or confirmed diseases. similarly, life sciences companies create pharmaceuticals, biologics, and other medical products based on their ability to treat diseases. in addition, public health agencies, patient advocacy groups, 8 see, e.g., david blumenthal, launching hitech, 362 new eng. j. med. 382, 384 (2010). in addition, through health information exchanges, states and the federal government are creating integrated forums for electronic health records and contemplating use of aggregated and de-identified data for population-based research. see parasidis, supra note 2, at 966-67. 9 the office of the national coordinator for health information technology "is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology." about onc, u.s. dept. of health and human services, available at http://healthit.hhs.gov/portal/server.pt/ community/healthithhsgov-onc/1200. 10 see e. kaltenthaler, r. maheswaran, & c. beverley, population-based health indexes: a systematic review, 68 health policy 245, 246 (2004). 11 see efthimios parasidis et al., a dynamic method for quantifying healthcare status and burden of disease through health outcomes indices, 15 technology & innovation 31, 31 (2013). 450 vol.10:2 health information technology and provider networks coordinate management plans with the goal of addressing patients with specific diseases. as such, the preferred method of measuring health outcomes at the population level should match industry's primary concern, which is treating patients by disease in order to improve health outcomes. the lack of robust outcomes-based metrics hinders detailed evaluation of treatment options and contributes to health inequalities. for example, antibiotic use varies significantly by geography, yet current metrics do not permit clinical evaluation of whether such use correlates with improved health.12 similarly, although chronic disease management is known to vary drastically by zip code, 13 a dearth of outcomes data precludes meaningful comparative effectiveness research and hinders the ability of public health specialists to address health disparities across socioeconomic dimensions. 14 even within a single-payer framework, such as medicare or the u.s. department of veterans affairs (va), there is significant regional variation in cost, quality, and quantity of health care.15 12 see m. steinman, variation in outpatient antibiotic prescribing in the united states, 15 am. j. manag. care 861 (2009); antibiotics aren't always the answer, u.s. centers for disease control and prevention, available at http://www.cdc.gov/features/getsmart (last accessed aug. 21, 2012); see also michael e. porter & elizabeth olmsted teisberg, redefining competition in health care, harvard business rev., at 1 (june 2004), available at http://hbr.org/weblextras/insightcenter/health-care/redefining-competition-in-health-care (arguing that, across the health care industry, "[t]here are wide and inexplicable differences in costs and quality among providers and across geographic areas"). 13 see, e.g., diabetes report card, centers for disease control, at 3 (2012) [hereinafter 2012 cdc diabetes report card], available at http://www.cdc.gov/diabetes/pubs/pdf/diabetesreportcard.pdf. 14 see, e.g., parasidis et al., supra note 11, at 31. 15 leonard e. egede et al., regional, geographic, and ethnic differences in medication adherence among adults with type 2 diabetes, 45 annals pharmacotherapy 169, 170 (2011); porter & teisberg, supra note 12, at 5 (noting that "there is an almost threefold variation in annual costs per medicare enrollee [and] higher costs are not associated with better medical outcomes and cannot be explained by differences in age, sex, race, rates of illness (which affect the need for care) or cost of living (which affects the cost of delivering care)"). 4512013 indiana health law review improved health outcomes are important to promote occupational, social, and family productivity, and to enhance treatment effects, all of which can reduce the cost of health care. however, due to the rising costs of health care and the lack of an objective and quantitative method to value health outcomes, there exists a substantial risk for payer-based decisions to cut products and services without knowing what the effects of the cuts will be on the health of patients. hois endeavor to fill this void by providing stakeholders with a dynamic and accurate metric that measures and assesses patient outcomes over time. the guiding principles underlying the hoi model are to (1) determine if populations are better off today than they were in the past, (2) facilitate comparative effectiveness research, and (3) assist in identifying and addressing health disparities by demography and geography. 16 whereas the method of creating hois has been discussed in the literature,' 7 this essay highlights the three-phased process and uses diabetes as an example of how hois may be applied to clinical care and disease management. the three-phased approach to the hoi model proceeds as follows: in hoi phase i, the target population and the outcome-of-interest must be clearly identified.18 hoi phase ii includes data collection and algorithm generation.' 9 for both areas, one must consider relevant clinical, economic, and humanistic data.20 data sources may include electronic medical records, patient registries, adverse event reports, 16 see parasidis et al., supra note 11, at 33-34. 17 see generally id. 18 see id. at 34. 19 see id. at 34-35. 20 see id. at 34. clinical data refers to: "outcomes related to treatment failures, signs, symptoms, and biomarkers specific to each disease being measured. clinical outcomes relevant to each disease are typically discussed in the medical literature and can be confirmed by clinician panels and real-world evidence [for each hoil" id. economic data refers to: "financial-related outcomes such as direct and indirect costs of treating diseases. economic outcomes can include those measured through cost-benefit, cost-minimization, cost-effectiveness, cost-utility, burden-of-illness, and resource-utilization analyses." id. humanistic data refers to: "quality of life, productivity and other patient-reported outcomes measured largely through surveys." id. 452 vol. 10: 2 health information technology clinical trial data, post-market research, patient surveys, quality of life indicators, and peer-reviewed literature. 21 the second component of phase ii-algorithm generationrefers to the creation of an algorithm that assigns relative weights to the data in order to produce a metric that reflects the outcome of interest.22 throughout the hoi process, consultation with specialists and key opinion leaders is essential to ensure that: (a) the underlying sources provide reliable data that reflect the burden of disease, and (b) the algorithm combines the data in a way that produces an accurate measure of outcomes. 23 hoi phase iii involves risk adjustment and baselining the population to ensure that statistically significant figures can be produced. 24 envisioning the hoi model is best achieved through a case study, and type 2 diabetes provides an illuminating paradigm. type 2 diabetes affects over 24 million americans, while an additional 75 million americans have been diagnosed with prediabetes. 25 annual medical costs exceed $218 billion, and the centers for disease control and prevention (cdc) predicts that, if current trends continue, by 2050 one in three adults will have the disease.26 diabetes leads to many health ailments and complications that include heart disease, stroke, vision loss, kidney failure, and amputations. 27 effective control of glucose and blood pressure can prevent or delay these complications. 2 8 21 see id. at 35. 22 see id. at 34-35. 23 see id. at 35-37. 24 see id. at 35. 25 2012 cdc diabetes report card, supra note 13, at 1. worldwide, diabetes has become one of the leading chronic diseases, with prevalence and incidence rates far higher than predicted. m. uusitupa, j. tuomilehto, & p. puska, are we really active in the prevention of obesity and type 2 diabetes at the community level?, 21 nutrition, metabolism & cardiovascular diseases 380, 380-81 (2010). 26 2012 cdc diabetes report card, supra note 13, at 2; egede et al., supra note 15, at 169. 27 2012 cdc diabetes report card, supra note 13, at 1. 28 id.; andrea c. tricco et al., effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta -analysis, 379 lancet 2252 (june 16, 2012); egede et al., supra note 15, at 169. 2013 453 indiana health law review yet, despite decades of attention, "still today no serious strategy exists to address the need to prevent the rapidly rising population of people with diabetes."29 diabetes rates vary significantly across demographic and geographic characteristics. rates of diabetes among american indian and alaskan natives (16.1%) are more than twice those of non-hispanic whites (7.1%), while rates among hispanics (11.8%) and non-hispanic blacks (12.6%) are notably higher when compared to non-hispanic whites (7.1%).30 across the united states, prevalence rates range from 5.8% in vermont to 11.3% in mississippi, and the southeastern portion of the united states has a disproportionately high percentage of citizens with diabetes. 31 preventative care also varies dramatically by state. for example, 73.2% of patients in tennessee measure their blood sugar daily, compared to 55% in south dakota. 32 in new york, 40.9% of patients have attended a diabetes self-management class, compared to 77.1% in minnesota. 33 research has also documented statistically significant racial and ethnic differences in medication adherence for diabetes patients within a single-payer system such as the va. 3 4 although the aforementioned data provide general insights into diabetes prevalence and treatment, 35 the key 29 uusitupa, tuomilehto, & puska, supra note 25, at 381. 30 2012 cdc diabetes report card, supra note 13, at 1. 31 id. at 3. 32 id at 6. 33 id. 34 egede et al., supra note 15, at 172. 35 notably, the patient protection and affordable care act of 2010 (ppaca) mandates that cdc monitor trends in diabetes and provide the public with current information related to the disease. see 2012 cdc diabetes report card, supra note 13, at inside cover. the annual cdc diabetes report card is the culmination of this work. despite its mandate, the report card almost exclusively focuses on prevalence and disease management compliance rates. the report in passing refers patients to other sources of information, none of which is identified as containing outcomes data. id. at 7. while the report provides valuable information, there is no measurement that reflects the extent to which preventative measures lead to improved outcomes. the lack of outcomes data is troubling given the number of patients with diabetes and the cost of care. the cdc report fails to deliver on the agency's promise to provide "public health leadership to translate evidence-based vol.10:2454 health information technology questions are whether subpopulations of patients experience better health outcomes and why. are treatment regimens different? does one population enjoy better access to healthy and affordable foods?36 is insurance coverage of health club membership relevant? the list could go on, but the point remains traditional metrics that focus on prevalence and incidence are limited in their ability to assess outcomes. to be sure, additional studies provide important clinical analysis of patient outcomes. one recent study found that untreated comorbid depression has serious adverse health implications for patients with diabetes, since depression contributes to poor self-care and less treatment, and that there are significant racial and ethnic differences in mental health diagnosis and treatment. 37 another found that a small reduction in weight (5%) translates to a 60-70% reduction in diabetes risk.38 without question, diabetesrelated research has generated a massive number of peerreviewed articles. for example, a recent search of peerreviewed medical literature retrieved over 160,000 articles related to diabetes over the last decade. 39 each study reveals an important piece of the diabetes puzzle. we know that the rates of diabetes are increasing, that there is significant variation in disease treatment and management across sub-populations, and that active disease management can help prevent or delay diseaserelated complications. 4 0 we do not know with sufficient certainty whether certain interventions or therapies tend to produce better results, or the extent to which science on what works into practice to improve health outcomes for people with diabetes." id. at 8. 36 see, e.g., nathan seppa, neighborhood linked to obesity, science news, at 17 (june 2, 2012) (discussing research that found correlations between obesity rates in children and proximity to parks and grocery stores that sell fresh fruits and vegetables). 37 dara h. sorkin et al., underdiagnosed and undertreated depression among racially/ethnically diverse patients with type 2 diabetes, 34 diabetes care 598, 598-99 (2011). 38 uusitupa, tuomilehto, & puska, supra note 25, at 387. 39 i conducted the search via pubmed on july 19, 2012. 40 tricco et al., supra note 28, at 2252. 4552013 indiana health law review subpopulations need varied approaches to care and management. as a recent meta-analysis of quality improvement strategies and diabetes disease management plans explains, "[a]lthough clinicians, managers, and policy makers expend significant time and resources attempting to optimize care for patients with diabetes, the optimum approach to improving diabetes care (and outcomes) remains uncertain."41 the hoi model aims to fill this gap. one of the defining aspects of the hoi model is an algorithm that captures a diverse set of data points. in turn, by creating multiple hois for subpopulations, drilldown biomedical informatics capabilities facilitate meaningful comparisons between various groups. subpopulations can, for example, be stratified by age, gender, ethnicity, insurance coverage, zip code, or other characteristics. taken together, the hoi model brings together the world of data in a format that provides macro and micro investigation. figure 1 provides a visual depiction. 42 figure 1 diabetes clnct event w mo health event policy news outcomes 120 event event 110 * m* * 100__d %.. 03 04 01 02 03 04 q1 02 03 04 2010 2011 2012 2013 figure 1 reflects the change in a type ii diabetes index over time. as the index increases or decreases, the health of the underlying population can be said to be improving or 41 id. 42 the figures in this essay are hypothetical and for discussion purposes only. 456 vol. 10:2 health information technology not; robust data mining then allows for a detailed understanding of why. for example, some changes in the index may be correlated with clinical, research and development, or policy events. further investigation can uncover whether the correlation is statistically significant and whether the underlying changes can inform best practices. as figure 2 depicts, modeling hois across subpopulations of a disease allows for further analysis. figure 2 subpopuatni a *. * *subpcpulation 8 x a x subpopulaton c type if diabetes 120 health outcomes indices 110 * 10x *411 0 .0 'l . .00 it lit 0 iii xx% x i it x11 03 04 01 02 03 04 01 02 03 04 2010 2011 2012 2013 figure 2 represents an overlay of hois for three subpopulations of patients diagnosed with type 2 diabetes. modeling across subpopulations allows for macro analysis of outcomes at the population level. examining divergence and convergence, along with trends and comparative rates of increase or decrease, informs disparities-related analysis, and provides an evidence-based approach to clinical care and public health policy. for example, while subpopulations a and b experienced improved outcomes through q3 and q4 of 2012, subpopulation c did not. likewise, the rate of increase across all subpopulations varies for much of the examined time period. unraveling the components of each hoi can help reveal why. figure 3 provides an example of how one may parse out the components of multiple indices to understand how each component is changing over time. as figure 3 illustrates, each factor (economic, clinical, and humanistic) may be comprised of multiple components. similarly, each 2013 457 indiana health law review component can be broken down into sub-components to permit a more detailed analysis. 43 by way of example, figure 3 represents data from the three subpopulations of figure 2, where each factor is comprised of three components. figure 3 type 2 diabetes health outcomes indices subpopulation a subpopulation b subpopulation c index % change index % change index % change economic el 133.2 +2.3% 128.9 -0.8% 150.7 -1.4% e2 87.9 +1.1% 90.9 +0.3% 92.2 +1.5% e3 112.5 -3.0% 115.7 +0.5% 119.6 -2.5% clinical ci 89.7 +1.1% 90.8 +1.9% 92.7 +2.7% c2 95.8 -0.4% 99.6 -1.2% 90.9 -1.2% c3 121.1 +2.3% 112.8 -0.9% 124.8 +0.2% humanistic hi 104.6 +3.4% 100.9 +0.1% 90.8 -1.1% h2 100.3 +0.9% 104.6 +0.4% 88.3 -0.4% h3 88.7 +1.3% 92.6 -1.1% 82.4 -2.1% hoi 109.8 +1.4% 106.4 +0.7% 92.3 -2.8% as figure 3 illustrates, comparative analysis of the economic, clinical, and humanistic factors across subpopulations reveals detailed information on what drives variation in health outcomes. for example, the outcomes of subpopulation a increased at a rate twice that of subpopulation b. examining the components of each data set reveals the key drivers behind this disparity. between subpopulations a and b, components el, c3, hi, and h3 were notably higher for subpopulation a, both in terms of raw score and percent change over time. as a whole, while outcomes for subpopulation a improved more than subpopulations b and c, aspects of the b group (such as e3 and ci) improved at a rate higher than the a group, and aspects of the c group (e2 and c1) improved at a rate greater than both the a and b groups. this was true 43 for the sake of brevity, the subcomponents are not identified in figure 3. subcomponents of el, for example, would include ela, elb, . . elx. 458 vol. 10: 2 health information technology despite significantly lower outcomes for the c group. targeting specific components through disease management plans may increase the likelihood that outcomes will improve for each subpopulation. in essence, each hoi is created by meaningfully combining relevant data, and may be dissected to reveal the extent to which individual factors impact health outcomes. many sectors have utilized indices as a helpful method of measuring and assessing economic and social trends, 44 and one provider network in minnesota recently created a composite measure for diabetes care for individual patients.45 a dynamic population-based health outcomes index can reflect the big picture of the state of disease and can be broken down to determine how subpopulations are dealing with disease. insofar as the "costly consumption of health services at the macro level originates at the micro level . . . [ilf informed decision making shifts the dynamics of these choices, the effects on health care costs and other resources can be sweeping, with ripple effects that influence benefits packages, health insurance premiums, and access to care." 4 6 the hoi model represents a promising tool that can help achieve these goals. ii. health outcomes-based financial derivative instruments in addition to serving as a tool with which to measure and assess health outcomes, hois may provide a basis from which to create financial derivative instruments.47 44 the housing industry, with the case-shiller home price indices, is a notable example. see generally s&p dow jones indices, s&p/case -shiller home price indices methodology (nov. 2009). 45 see young, supra note 1, at 580 (indicating that the measure includes "a patient's results for hemoglobin, alc, blood pressure, and cholesterol"). 46 see woolf et al., supra note 3, at 298. 47 while health care as whole is not a commodity, there are aspects of the health care industry that may be properly characterized as a commodity. see porter & teisberg, supra note 12, at 4; edmund d. pellegrino, the commodification of medical and health care: the moral consequences of a paradigm shift from a professional to a 4592013 indiana health law review derivatives offer stakeholders a unique means of managing risk and investments. 48 by using derivatives to hedge risk, companies aim to reduce variability and volatility in financial performance and cash flows, two goals that are highly valued in the business and investment communities. 49 the allure of derivatives is best illustrated by the value of existing contracts. in december 2011, the notional value of over-the-counter derivatives was estimated at over $640 trillion,50 an amount that dwarfs the $69 trillion of total global gdp.51 although the recent financial crisis has highlighted problems with the derivatives market, 52 derivatives are not inherently corrupt and, if properly used and regulated, could provide significant benefits to stakeholders throughout the healthcare industry.53 for purposes of this essay, i discuss market ethic, 24 j. med. & philosophy 243, 247 (1999) (arguing that "[clommodities may be used in the process of providing care, but the totality of health care itself is not a commodity"). 48 see james a. hayes, joseph b. cole, & david i. meiselman, health insurance derivatives: the newest application of modern financial risk management, 28 business economics 1 (april 1993). derivatives include swaps, options, swaptions (options to enter into swaps), futures, and forward contracts. see derivative instruments and hedging activities, ernst & young report, at 12 (sept. 2011) [hereinafter ernst & young report]. by shifting risk to those who prefer to carry risk or are paid to do so, derivatives facilitate focused investments and wealth maximization. see hayes, cole, & meiselman, supra, at 1. 49 see ernst & young report, supra note 48, at a-1 (in-dicating that analysts and investors reward companies who do not have volatility in earnings). 50 see global otc derivatives, the economist (may 12, 2012), available at http://www.economist.com/node/21554558. this represents an increase of over 500% from 2002. see derivatives, the new york times, updated oct. 19, 2011 (citing figures from the bank for international settlements in switzerland), available at http://topics.nytimes.com/topics/reference/timestopics/subjects/d/derivati ves/index.ctx?partner=rssnyt. 51 see world bank data, available athttp://www.worldbank.org. 52 see generally l. randall wray, the rise and fall of money manager capitalism: a minskian approach, 33 cambridge j. econ. 807, 809 (2009). 53 see g. philip rutledge & rob bertram, a brief guide to financial derivatives, pennsylvania securities commission (2d ed. 460 vol. 10: 2 health information technology how hoi-based derivatives may benefit payers, providers, innovators, public health agencies, and patients. unexpected volatility could have a devastating impact on payers and other stakeholders. payers set premiums at a level that aims to cover the cost of care and administrative costs, and to generate profit. new regulations governing medical loss ratios cap the non-medical expenditures for most health plans between 15-20% of premiums.5 4 payers are required to refund any portion of premiums that exceed this threshold.55 if actual payments exceed anticipated payments, payers are unable to go back and charge additional premiums, and are unlikely to be able to recoup lost expected earnings in subsequent years. 56 given the new regulations, now more than ever, how payers determine coverage and reimbursement rates is of integral importance. absent robust outcomes-based metrics, patients and providers run the risk that payers will limit coverage or reimbursement primarily for business reasons, or in a way that negatively impacts the quality of care. while hois can serve as tools that use outcomesrelated data to help set coverage and reimbursement rates, 1995), available at http://www.psc.state.pa.us/corpfinance/derivatives. html. the use of derivatives dates back at least to the nineteenth century, when farmers and traders bought and sold corn futures in an effort to reduce risk. see, e.g., derivatives, supra note 50. since that time, "a bewildering variety of derivatives have been developed." id. stakeholders in the health care industry have a history of using derivatives to hedge risk. for example, non-profit health care providers have successfully used derivatives to manage long-term debt acquired to finance information infrastructure and clinical equipment needs. see, e.g., louis j. stewart & vincent owhoso, derivative financial instruments and nonprofit health care providers, 31 j. health care finance 38, 38 (2004). in addition, health insurance futures contracts have been discussed in the literature since at least the 1990s. see, e.g., hayes, cole, & meiselman, supra note 48, at 1. 54 45 cfr 158, 76 fed. reg. 76574 (dec. 7, 2011). 55 id. 56 implementation of health insurance exchanges under ppaca is likely to lead to increased competition in the insurance market, and thus insurance companies must be mindful of increases in premiums. given increased competition and the need to offer competitive rates, insurance companies may find it difficult to increase premiums to the point where lost expected earnings can be recovered. 4612013 indiana health law review hoi-based derivatives can serve as a means of hedging risk in this area.5 7 as a buyer, payers are likely to take a long position to hedge risk that payments in a given year will exceed estimates for certain subpopulations of their covered lives, for example, patients with chronic or costly diseases. as sellers, providers or innovators are likely to take a short position, insofar as lower-than-expected claims implies less services rendered and medical products used.58 as studies have revealed, with increasing co-payments and higher deductibles, patients are often electing to forego nonessential treatment. 59 moreover, as patients gain access to outcomes data that reveals increased risk of complications, they are refusing or deferring treatment. 60 this creates risk for providers and innovators that hedging could mitigate. innovators face further uncertainties. the costs of drug development are massive current estimates place the figure at $1.2 billion while the risks are high.61 for drugs that enter human clinical trials, approximately 8% earn fda approval.62 taken together, high development costs and low approval rates hinder innovation. studies have documented the lack of innovative medical products and industry's focus on me-too drugs, which are drugs that mimic successfully marketed products. 63 hoi-based 57 see stephen p. d'arcy & virginia grace france, catastrophe futures. a better hedge for insurers, 59 j. risk & insurance 575, 580 (1992). 58 see, e.g., hayes, cole, & meiselman, supra note 48, at 1 (indicating that payers and providers are natural buyers and sellers of futures contracts related to insurance coverage). 59 see anne b. martin et al., growth in us health spending remained slow in 2010 health share of gross domestic product was unchanged from 2009, 31 health affairs 208 (jan. 2012); woolf et al., supra note 3, at 294. 60 see martin et al., supra note 59, at 208; woolf et al., supra note 3, at 294. 61 see christopher paul adams & van vu brantner, spending on newdrug development, 19 health econ. 130, 138 (2010). 62 see editorial, mechanism matters, 16 nature medicine 347 (2010). 63 see, e.g., brita pekarsky, should financial incentives be used to differentially reward me-too' and innovative drugs?, 28 462 vol. 10:2 health information technology derivatives can spur innovation by allowing innovators to hedge risk.64 for example, innovators can buy a long position that their product will fail, while competitors could purchase short positions that would mitigate the risk of a successful new product capturing market share. use of hoi-based prediction markets is also worth exploring. a myriad of factors impacts the ability of stakeholders to forecast accurately the demand for medical services and products. 65 prediction markets aim to improve the decision-making process by providing a forum for trading contracts that yield payments based on the outcome of uncertain events. 66 prediction markets have the potential to help businesses manage investments, and help governments make better policy decisions. 67 in the health care arena, prediction markets have been used to predict the likelihood of a nationwide flu epidemic and the success pharmacoeconomics 1, 2 (2010); i. kola, the state of innovation in drug development, 83 clinical pharmacology & therapeutics 227 (2008). 64 see d'arcy & france, supra note 57, at 579 (arguing that, if used properly, futures contracts can lower entry costs for a company). 65 see u.s. agency for international development, quantification of health commodities: a guide to forecasting and supply planning for procurement, at 8-16 (march 2009) [hereinafter usaid report]. these include changes in policies, the emergence of new products, changes in financing, changes in coverage and reimbursement rates, newly discovered risk-benefit information, geographic variation in incidence and severity of disease, and changes in the political, legal, or regulatory environment. see id. at 8. 66 kenneth j. arrow et al., the promise of prediction markets, 320 science 877, 877 (may 16, 2008); see generally michael abramowicz, predictocracy: market mechanisms for public and private decision making (yale university press 2008) (discussing prediction markets); justin wolfers & eric zitzewitz, prediction markets, 18 j. econ. perspectives 107 (2004) (same). the utility of prediction markets lies in their ability to forecast. see philip m. polgreen, forrest d. nelson, & george r. neumann, use of prediction markets to forecast infectious disease activity, 44 healthcare epidemiology 272 (jan. 2007), available at http://cid.oxfordjournals.org/content/ 44/2/272.full.pdf+html. the trading price of the financial instrument reflects "a consensus belief about the future value of the instrument and thus can be used as a prediction of the future event." id. 67 see arrow et al., supra note 66, at 877. 2013 463 indiana health law review of new drug treatments. 68 for example, eli lilly and company has used internal prediction markets to help predict which drugs under development have the best chance of advancing through clinical trials.69 preliminary research reveals that when prediction markets use clinical data and expert opinions, they can be useful in tracking and forecasting infectious diseases, can "inform treatment, prevention, and policy decisions . . . [and] help to refine existing surveillance systems."70 for example, prediction markets may help estimate the success of interventions or predict the likelihood that a new drug or vaccine earns regulatory approval. 7 ' prediction markets can also be used to predict the timing and strain of seasonal influenza, which could help public health officials and manufacturers of vaccines. 72 while prediction markets have limitations and their applicability in the healthcare arena needs further validation, preliminary findings suggest that the markets could supplement the existing business and policy framework. 73 it is again worthwhile to note that the goal of this essay is to contemplate the next quarter century of health care law. indeed, there are important details that would need to be addressed for outcomes-based derivatives to be implemented.74 these include transparency in the creation of the underlying metric and market confidence in the metric's ability to accurately reflect risk-adjusted health outcomes. other factors include accounting and tax issues, the legal and regulatory framework, the role of 68 see id. the iowa electronic health markets are paradigmatic. see iowa electronic health markets, available at http://iehm.uiowa.edu/ iehm/index.html (last visited aug. 30, 2012). 69 see polgreen, nelson, & neumann, supra note 66, at 273. 70 id. at 272. 71 id. 72 see id. at 279. 73 see id. 74 see, e.g., hayes, cole, & meiselman, supra note 48, at 1 (identifying factors that are integral to the success of a futures market); roger w. gray, why does futures trading succeed or fail:'an analysis of selected commodities, in proceedings of the futures trading seminar, at 115-37 (1966). 464 vol. 10:2 health information technology clearinghouses, and the socio-medical impact of such a market on the industry.75 speculation must also be addressed; while speculators can benefit a futures market through an influx of liquidity, the risk of price destabilization is real. 76 regulation should aim to limit the impact of speculation on derivatives markets, and particularly for health-based derivatives where contract prices are likely to impact noncontracting parties such as patients. as a former cftc commissioner succinctly stated, "[wle need a sheriff in the saddle, to make sure these markets are honest."7 7 insofar as forecasting supply and demand in the health care industry is challenging and the stakes are high,78 effective use of hoi-based derivatives will provide health care stakeholders with an additional tool with which "to more accurately predict financial performance and manage the investment community's expectations."79 iii. conclusion at a time where informatics capabilities and interest in outcomes-related data are flourishing, the demand for meaningful outcomes metrics is likely to produce a myriad of products and services.80 this shift may help address one 75 see e.g., wray, supra note 52, at 809 (discussing derivatives and warren buffett's term "financial weapons of mass destruction" as it relates to the derivatives market); neil duxbury, do markets degrade." 59 modern l. rev. 331 (1996). 76 see, e.g., megan s. chapman, rising global food prices. the need for re-regulating commodity futures, 9 sustainable development law & policy 43, 43 (2008), available at http://digitalcommons.wcl.american.edu/cgilviewcontent.cgi?article=108 9&context=sdlp. 77 see id. 78 see generally usaid report, supra note 65 (outlining the complex process of forecasting and the importance of robust measures in developing an accurate forecast). 79 see ernst & young report, supra note 48, at a-1. 80 see woolf et al., supra note 3, at 298 ("perhaps nothing is changing more dramatically in health care than the increased volume and influence of information. patients face a growing need for assistance in knowledge management and for access to professionals 2013 465 indiana health law review of the key ailments of the health care system. some health economists and health policy experts have argued that the "wrong kinds of competition have made a mess of the american health care system. the right kinds of competition can straighten it out."81 to the extent that competition in health care has evolved to become zero sum, an alternative approach is preferable. 82 as michael porter and elizabeth teisberg explain, remedying the imbalances requires competition: [i]n the prevention, diagnosis, and treatment of individual health conditions or co-occurring conditions. it is at this level that true value is created or destroyed disease by disease and patient by patient. it is here where huge differences in cost and quality persist. and it is here where competition would drive improvements in efficiency and effectiveness, reduce errors, and spark innovation.83 insofar as "competition at the level of individual health conditions is all but absent,"84 the hoi model aims to fill this gap. who are qualified for this task. as the volume of information and the complexity of choices increase, this need will only grow more urgent."); young, supra note 1, at 578 (noting that public reporting of health outcomes aims to promote transparency and provide patients with relevant information). 81 see porter & teisberg, supra note 12, at 1. 82 see id. at 2. in particular, rather than focusing on cost reduction the market focuses on cost shifting. id. (explaining that "[closts are shifted from the payer to the patient, from the health plan to the hospital, from the hospital to the physician, from the insured to the uninsured, and so on"). this process creates no net value, and typically adds significant administrative costs. see id. moreover, many health plans incentivize cheaper, rather than effective, treatments. see id. for example, since the commitment between patient and health plan is typically for one year, "both payers and employers are motivated to engage in short-term thinking rather than invest in practices and therapies that will improve value over time." id. at 4. 83 see id. at 2. 84 see id. at 2-4. as porter and teisberg explain, "[c]ompetition at the level of individual diseases and conditions is getting even more 466 vol.10:2 health information technology accountability in health care depends on accurate, objective, and accessible information related to quality measures and health outcomes. 85 the stakes are unquestionably high, and a diverse spectrum of stakeholders stands to gain or lose from the influx of information. for example, significant earnings may be at stake if bioinformatics analyses or post-market research reveals that a product is not as safe or effective as believed. likewise, "the threat of malpractice suits creates risks for providers who try to learn from bad outcomes by measuring and analyzing them."8 6 on the other hand, patients and providers can use outcomes-based data to inform medical decisions and clinical care.87 taken together, robust outcomes-based metrics will provide evidence-based clinical decision support and corporate management tools.8 8 as pay-for performance becomes an increasingly important component of the health important as medical research reveals that diagnoses and treatments should be increasingly specialized." id. at 4. 85 see ezekiel j. emanuel & linda l. emanuel, what is accountability in health care." 124 ann. intern. med. 229, 233 (1996); see generally cass r. sunstein, infotopia: how many minds produce knowledge (oxford university press 2006) (discussing benefits and risks of using information technology to produce evidencebased decisions). 86 see porter & teisberg, supra note 12, at 7 ("ironically, while technology has made knowledge diffusion faster and easier than ever before, the social and economic structures of the health care sector work against the rapid dissemination of learning."). 87 see, e.g. h. gilbert welch, testing what we think we know, new york times (aug. 19, 2012) (indicating that "for a large part of medical practice, we don't know what works," and calling for more robust outcomes-related research). 88 given the limited outcomes-related information, patients of-ten are asked to make difficult treatment decisions without meaningful information. see porter & teisberg, supra note 12, at 3; see also woolf et al., supra note 3, at 293 (arguing that "[t]he health care system cannot truly support informed decision making without correcting the underlying obstacles that impede patient access to needed information"). most hospitals and providers do not disclose outcomesdata, often arguing that risk adjustment is impossible or too difficult, or that disclosing outcomes may impact medical malpractice. see porter & teisberg, supra note 12, at 6. yet, outcomes are the ideal method by which to determine treatment options. see id. at 4. 4672013 indiana health law review care delivery system, accurate outcomes-based metrics are essential to ensuring that performance is evaluated properly. 89 to ensure that the information is reliable, 90 regulators and public health specialists must take steps to frame a healthy arena for outcomes-based metrics that incentivize robust disclosure and punish deceptive tactics or the manipulation of data.91 89 see, e.g., id. at 12-13; young, supra note 1, at 580 (noting that outcomes data is increasingly being incorporated into health system metrics). an example is telling: new york health officials actively collected outcomes data related to cardiac bypass surgeries performed statewide, and made the data publicly available. in response, providers altered treatment methods based on the best outcomes, and some hospitals revoked the privileges of underperforming doctors. within four years, new york had the lowest risk-adjusted mortality rate in the country. see porter & teisberg, supra note 12, at 6. 90 see id. at 7 (noting that "america cannot afford to wait for perfect information to be developed before it can be disseminated. nothing will drive improvements in information faster than making the existing data widely available."). 91 for public policy decisions in health care to be sound, "they should be based on a solid understanding of the processes that have led to the current situation and some reasoned analysis" of relevant factors. h. leufkens et al., scenario analysis of the future of medicines, 309 british medical journal 1137, 1137 (1994). while "nlew discoveries constantly advance the possibilities of drug treatment . . . society is increasingly concerned about rising drug costs, safety issues, and the sometimes irrational use of existing medicines." id. as such, there is a "need for a quantified insight into how drug treatment is actually conducted and what its positive and negative consequences are in terms of health, cost, and value for society as a whole." id. conflict of interest disclosure: the methods, systems, and apparatus discussed herein were first disclosed in a u.s. patent application titled computer implemented methods, systems, and apparatus for generating and utilizing health outcomes indices and financial derivative instruments based on the indices (us2010/0004945), of which i am a co-inventor. a related patent application is pending in singapore (no. 201009500-8), and an application has been filed pursuant to the patent cooperation treaty (pct/us09/49223). the patent applications are assigned to global health outcomes, inc., of which i am a co-founder, officer, and board member. 468 vol. 10: 2 2013 health information technology 469 contemplating new uses of outcomes-based metrics and financial derivative instruments will assist regulators and policymakers in structuring appropriate regulations. despite the snail-like pace of health it adoption and implementation, regulators should be mindful to take a proactive approach to structuring a legal framework that harmonizes the interests of patients, providers, payers, and innovators. with a dynamic framework in place, hois and hoi-based derivatives stand to assist the health care industry in achieving the aspirational goals of reducing health care costs and improving health outcomes. articles idstory of the mcdonald-merrill­ ketcham memorial lecture and award the story of this award and lectureship begins with a visionary alumna of indiana university: dorothy m. ketcham. miss ketcham received her bachelor of arts in economics in 1914 and her master of arts in sociology the following year. she joined the faculty of the university of michigan in 1921. in 1922, she became director of social services at the university of michigan hospital. in this capacity, she saw the important role that medi­ cine and law played in the lives of those whom she served. in 1928, she established a multifaceted workshop and recreational facility for children confined to the hospital. while at the university she also wrote several books, two ofwhich are devoted to hospital law. miss ketcham's affinity for the law grew out of her family's close re­ lationship with the legal system. her grandfather, david mcdonald, was a practicing attorney in indianapolis, as well as a circuit judge. he was ap­ pointed to the united states district court in 1864 where he served until his death. dorothy's father, william a. ketcham, was a well-known indianapo­ lis attorney. prior to being admitted to the bar in 1869, he studied law with his father, john l. ketcham and judge david mcdonald. william ketcham was elected to the office of state attorney general in 1894 and served two terms. miss ketcham's interest in the health law extended beyond her scholarship. in a trust she established for herself and four of her sisters (miss flora mcdonald ketcham, dr. jane m. ketcham, and misses lilla and lucia ketcham}, she made a remainder gift to the indiana university foundation to be used to assist the university in developing programs that would foster a greater unde~tanding and better relations between the professions of law and medicine. miss ketcham was especially interested in furthering the careers of young medical and law students and instilling in them an appre­ ciation for both professions. miss ketcham's generous gift, named for her grandparents (judge david mcdonald, john l. ketcham and jane merrill ketcham}, funds this prestigious lectureship and award for an individual who has demonstrated excellence in the fields of common interest to the two professions. it is fit­ ting that the university honor miss ketcham's wishes by bringing to our campus distinguished scholars and leaders who bridge the gap between law and medicine. by inviting them to share their expertise with students, fac­ ulty and leaders of the legal and medical professions, we continue to sup­ port the ideals that dorothy m. ketcham espoused in her life and work. in recent years, the lecture and award have been made in collaboration with the medical humanities program, a new interdisciplinary project based in the school of liberal arts. this addition further integrates law and medi­ cine into the academic community and encourages each discipline to think of itself in relation to others. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i mcdonald-merrill-ketcham memorial lecture and award in conjunction with the indiana university school of medicine, the law school sponsors the annual mcdonald-merrill-ketcham memorial lectureship and award for excellence in law and medicine. supported by a bequest to the two schools, this lectureship and award brings leading scholars and policy makers in the fields of law and medicine to the indian­ apolis campus for the benefit of students, faculty, the bar and the medical community. the inaugural program was held in november 1994. award recipients and their articles are listed below. articles based on the lectures presented were published in the indiana law review until 2002, at which time the lectures started being published in the indiana health law review. • 1994tom l. beauchamp, professor ofphilosophy and senior research scholar at the kennedy institute at georgetown universi­ ty. the justification of physician-assisted deaths, 29 ind. l. rev. 1173 (1996). • 1996frances h. miller, professor oflaw at boston university school of law and professor of public health at boston university school of medicine. health care information technology and in­ formed consent: computers and the doctor-patient relationship, 31ind. l. rev. 1019 (1998). • 1997 troyen a. brennan, professor of law and public health at harvard school of public health and professor ofmedicine at har­ vard school of medicine. beyond dead reckoning: measures of medical injury burden, malpractice litigation, and alernative compensation models from utah and colorado, 33 ind. l. rev. 1643 (2000). • 1998barry s. levy, immediate past president of the american public health association and adjunct professor of community health at tufts university school of medicine. twenty-first cen­ tury challenges for law and public health, 321nd. l. rev. 1149 (1999). • 1999bernard lo, professor of medicine and director of the pro­ gram in medical ethics at the university of california, san fran­ cisco. confidentiality of prescription drug information in the era of computers and managed care, 33 ind. l. rev. 937 (2000). • 2000clark c. havighurst, william neal reynolds professor at the duke university school of law. the backlash against man­ aged health care: hard politics make bad policy, 34 ind. l. rev. 395 (2001). • 2001 -robert j. levine, professor of medicine and lecturer in pharmacology at yale university school ofmedicine. internationiv indiana health law review [vol. 8:iii a/ codes of research ethics: current controversies and the fu­ ture, 35 ind. l. rev. 557 (2002). • 2002ruth r. faden, philip franklin wagley professor of bio­ medical ethics and executive director of the phoebe r. berman bioethics institute at johns hopkins university. liberty, public health, and national security: the challenge of smallpox, 1 ind. heal1hl.rev.1 (2004). • 2003 -h. tristram engelhardt, jr., professor of philosophy at rice university, professor emeritus in the department of medicine at rice university, and professor emeritus in the department of community medicine at baylor college of medicine. giving, sell­ ing, and having taken: conflicting views of organ transfer, 1 ind. health l. rev. 29 (2004). • 2004 randall r. bovbjerg, research associate, health policy center, the urban institute, washington, dc. beyond tort re­ form: fixing real problems, 3 ind. heal1h l. rev. 1 (2006). • 2005 -william m. sage, professor of law at columbia university. pay for performance: will it work in theory?, 31nd. heal1h l. rev. 303 (2006). • 2006 -james f. blumstein, university professor of constitutional law & policy, director of the health policy center, vanderbilt in­ stitute for public policy studies. of doctors and hospitals: setting the analytical framework, 41nd. heal1h l. rev. 209 (2007). • 2007george j. annas, edward utley professor and chair, de­ partment of health law, bioethics and human rights, boston uni­ versity school for public health. health care reform in america: beyond ideology, sind. heal1hl. rev. 441 (2008). • 2010david kom, m.d., vice provost for research at harvard university and professor of pathology at harvard medical school. financial conflicts of interest in academic medicine: whence they came, where they went, sind. heal1hl. rev. 1 (2011). donabedian's legacy: the future of health care quality law and policy donabedian's legacy: the future of health care qualirry law and policy kristin madison* introduction ........................................ 325 i. health care quality regulation in historical perspective ................................. ..... 327 ii. the last quarter century of health care quality law and policy ............................. ...... 332 iii. the next quarter century of health care quality law and policy: hopes and predictions .......... 345 a. predictions about quality law and policy ... ..... 345 b. hopes for quality law and policy. .............. 353 1. improvement in quality measurement capabilities .......................... .... 354 2. consolidation-related improvements in quality... 357 3. stronger external oversight mechanisms............359 4. systematic use of quality metrics in all healthrelated policies and programs ............... 362 iv. conclusion ............................ .... 363 introduction the organizers of this symposium assigned me a challenging task: to imagine the next twenty-five years of quality-related health care law. if the same question were put to me twenty-five years ago, my answer would have been wildly off the mark, and not just because i was still in high school. the world of health care quality law, policy, and practice changed tremendously between 1987 and 2012. it also looked quite different in 1987 than it did 1962. to envision health care quality law and policy in 2037 would require a truly robust imagination. suspecting that my own imagination would not be up to the task, i decided to answer a somewhat different version of the organizers' question: given the path that health care law and policy has taken in reaching its current form, what is its likely future * professor of law and health sciences, northeastern university. indiana health law review trajectory? and then, to add back in a bit of the imagination required by the original exercise, i added a second question: what do you hope will change over the next twenty-five years? this essay offers answers to both these questions. part i of the essay begins the analysis by examining the state of health care quality law as it existed throughout much of the twentieth century. in 1900, two legal tools featured prominently in the health care quality toolbox: malpractice law and professional licensure. by their nature, both are limited in what they can accomplish, but this fact seemed to be of little concern to legal commentators. the absence of sustained discussion of health care quality deficiencies in law journals of this era is striking. it was not until the 1970s and early 1980s that a few legal scholars, motivated in part by federal reform efforts directed at controlling costs, began to take a more comprehensive look at mechanisms for quality oversight. by the 1980s, health care quality law, policy, and practice had begun to experience a major shift in focus. as professor timothy jost explained in a 1995 article, "over time the focus of regulation [h changed from assurance of minimal professional competence . . . to consideration of quality as more globally defined."' part ii attributes this shift to several factors, including a growing commitment to building an evidence base for medical practice, a firmer analytic foundation for assessing health care quality, and a rapidly accumulating body of research documenting deficiencies in care. legal scholars of the late 1980s and early 1990s wrote a number of articles exploring the shift's implications for law and policy; part ii reviews some of their insights. the trend toward health care quality measurement that began to accelerate twenty-five years ago continues today. many recently established quality improvement policies and programs, including those embodied in the patient protection and affordable care act, reflect this trend. part iii describes these programs and highlights policymakers' 1 timothy stoltzfus jost, oversight of the quality of medical care: regulation, management, or the market, 37 ariz. l. rev. 825, 826 (1995). 326 vol. 10.2 donabedian's legacy efforts to respond to concerns previously raised by legal scholars. part iii predicts that the trend will continue for the foreseeable future, and then comments in more detail about the paths that quality measure-based reforms might take. while this essay expresses a mostly sanguine view of the evolution of health care quality law and policy, there remain many areas of concern and uncertainty and much room for improvement. the second part of part iii illuminates these issues by describing directions in which i hope that quality measure-based law and policy will go. it discusses ways that the evidence base for measurement and reporting could be improved, explores the implications of increasing consolidation among health care providers, and considers how quality measures could be integrated into more traditional quality oversight mechanisms. finally, it expresses the hope that the increasing availability of quality measures will foster a greater willingness to engage in health system experimentation. part iv concludes with observations about the future of quality improvement efforts in a world increasingly concerned about health care costs. i. health care quality regulation in historical perspective a leading health law scholar once identified health care quality as the primary concern of health law during the first half of the twentieth century. 2 this conclusion is not surprising, given the long history of two legal mechanisms intended to address quality deficits: medical malpractice law and medical licensure. the principles of tort law allowed injured patients to seek remedies for quality deficits well before 1900,3 while modern physician licensing regimes 2 see arnold j. rosoff, health law at fifty years: a look back, 14 health matrix 197, 198 (identifying health care quality as the primary concern of health law during the first half of the twentieth century). 3 see george j. annas, doctors, patients, and lawyers two centuries of health law, 367 new eng. j. med. 445, 445-49 (2012) (discussing the history of malpractice litigation); andrew a. sandor, the 3272013 indiana health law review had their origins in the late 1800s, when many states across the country enacted, or re-enacted, physician licensure laws.4 scholarly articles published in the early and midtwentieth century simultaneously highlight both the importance of tort law and licensure as mechanisms for policing quality, and the limitations of these mechanisms. a student comment in the yale law journal from the 1930s, for example, examines hospital liability for torts of hospital medical staffs, arguing that "[r]ules of liability should be framed to assure competent medical care, and yet the development of hospital facilities must not be discouraged."5 numerous articles discuss the problems of licensure regimes; an article from 1909 discusses constitutional issues surrounding medical licensure law,6 while articles from the 1940s such as legal control of medical charlatanism7 and legal control of medical practice: validity and methods discuss the difficulties of using the licensure regime to police the qualifications of physicians. while scholars of this era discuss ways to make these legal tools work better, they do not seem to focus on the inherent limits of these tools. malpractice law discourages physicians from departing from the norms established by their colleagues, while licensure's requirements exclude from practice those whose training is deemed insufficient to history of professional liability in the united states, 163 jama 459, 460 (1957) (citing a 1794 case as the first reported american malpractice case). for an example of a malpractice case from the 1800s, see small v. howard, 127 mass. 131, 135 (1880). 4 paul starr, the social transformation of american medicine 104 (1982). 6 liability of hospital for injuries to patients using hospital facilities, 48 yale l.j. 81, 81 (1938). 6 h.b. hutchins, characteristics and constitutionality of medical legislation, 7 mich. l. rev. 295 (1909). 7 s. earl heilman, legal control of medical charlatanism, 22 n.c. l. rev. 23 (1943) (discussing licensure regimes and the use of legal tools such as injunctions to preclude unauthorized practice of medicine). 8 kenneth c. sears, legal control of medical practice: validity and methods, 44 mich. l. rev. 689 (1946) (discussing various licensing issues, including due process considerations, equal protection concerns, and enforcement methods). vol. 10.2328 donabedian's legacy practice competently. even if these tools function as they should, their potential to encourage quality improvement is quite limited. adhering to medical custom will do little to improve health outcomes if the custom embodies poor quality care. licensure can exclude the most poorly trained providers, but it does nothing to encourage higher-quality care among those who have surpassed the requisite threshold. the broad topic of health care quality, however, did not seem to occupy the attention of health law scholars. many of the health-related articles published in the early to mid1900s focused on topics such as public health9 and the public financing of health care,' 0 rather than on health care delivery. a search of the heinonline law journal library database for law review articles published before the 1980s" revealed only one with a title containing the term "medical error," and it was about patient error, not provider error.' 2 written in the 1890s, the article considered how best to address "the popular overestimate of the potency of drugs."13 in other words, the article was motivated by the same concern that figured in both licensure regimes and 9 chester james antieau, the power of municipal corporations to protect the public health and safety, 1951 wash. u. l. rev. 358 (1951); ray a. brown, legislation for health and personal safety police power, 42 harv. l. rev. 866 (1929); marc a. franklin, medical mass screening programs:a legal appraisal, 47 cornell l. rev. 205 (1961); james a. tobey, public health and the police power, 4 n.y.u. l. rev. 126 (1927). 10 see, e.g., joseph p. chamberlain, the practicability of compulsory sickness insurance in america, 4 am. lab. legis. rev. 49 (1914); i.s. falk, an introduction to national problems in medical care, 6 law & contemp. probs. 497 (1939). 11 the author used the heinonline law journal library's advance search function to enter the searches "medical error," "iatrogenic," "title: 'medical error,"' and "title: 'quality,"' available at http-/home. heinonline.org/library-corner/resources/widget/. the search included all indexed articles, comments, notes, and reviews with publication dates before 1980. 12 e.p. buffet, a popular medical error to be corrected by the physician, 14 medico-legal j. 52 (1896). 13 id. at 53. 3292013 indiana health law review malpractice cases of that era: quackery.14 the next mention of "medical error" in a title did not occur until 1981, when professor barry furrow published an article arguing that malpractice litigation might help improve health care quality.15 expanding the search of early and mid-twentieth century law review articles to include a broader set of quality-related search terms turned up few additional examples. health care quality was sometimes briefly mentioned in articles focusing on other health-related subjects, such as health insurance, 16 but was rarely at the center of articles. by the 1960s and 1970s, some law review articles began to include more sustained discussions of health care quality, but their focus was often quite narrow. one group of articles fitting this description focused on food and drug law.' 7 the furrow article belonged to a second group: articles discussing medical errors or quality deficiencies in the context of medical malpractice litigation, 14 the 1880 massachusetts case small v. howard considered whether by referring to "others in the profession," a jury instruction might allow the standard of care to include practices of "all the mountebanks, ignorant pretenders, and imposters who undertake the practice of medicine and surgery." small v. howard, 127 mass. 131, 135 (1880). 15 barry r. furrow, latrogenesis and medical error: the case for medical malpractice litigation, 9 j.l. med. & ethics 4, 4 (1981). 16 see, e.g., comment, the essentials of an adequate health program, 59 yale l.j. 292, 303 (1950) ("the patient does not have the knowledge to select health care personnel on the basis of the quality of care given."); anne r. somers & herman m. somers, health insurance: are cost and quality controls necessary? 13 indus. & lab. rel. rev. 581 (1960) ("in the group practice environment, where the physicians' services are regularly under the scrutiny of professional colleagues and comparisons are virtually impossible to avoid, the positive effect on the quality of care has frequently been noted."). 17 see, e.g., william a. carpenter, jr., the federal food drug and cosmetic act as an experiment in quality control, 20 syracuse l. rev. 883 (1969); wilbur a. gould, w12y quality control, 19 food drug cosm. l.j. 217 (1964). the search also identified several articles focusing on quality in nursing homes. see, e.g., patricia a. butler, assuring the quality of care and life in nursing homes: the dilemma ofenforcement, 57 n.c. l. rev. 1317 (1979). 330 vol. 10.2 donabedian's legacy a hot topic in the aftermath of the 1970s malpractice crisis. 18 in 1970, the journal law and contemporary problems published a series of articles from a symposium organized by professor clark havighurst that did take a broader perspective on health care quality. the symposium was motivated not by a general desire to craft new approaches to quality improvement, but instead by a desire to "facilitate the formulation of the national health care program that will best meet the nation's needs." 19 within this context, "maintaining high quality standards" was a concern given "rapid change and serious shortages of essential resources." 20 symposium articles provided an overview and critique of the many quality regulation mechanisms in place, a list that had expanded beyond tort liability and professional licensure to include facility licensure, accreditation, certification, and institutional controls, among other mechanisms. 21 several bursts of quality-related scholarship in the latter part of the twentieth century followed the pattern established by the 1970 symposium: they focused on quality concerns that were tied to the financing of care. for 18 robert h. brook, rudolf l. brutoco & kathleen n. williams, the relationship between medical malpractice and quality of care, 6 duke l.j. 1197 (1975); comparative approaches to liability for medical maloccurrences, 84 yale l.j. 1141 (1975); clark c. havighurst & laurence r. tancredi, medical adversity insurance a no-fault approach to medical malpractice and quality assurance, 1974 ins. l.j. 69 (1974); reid f. holbrook & lee j. dunn jr., medical malpractice litigation: the discoverabiity and use of hospitals' quality assurance records, 16 washburn l.j. 54 (1977); m.w. reder, an economic analysis ofmedical malpractice, 5 j. legal stud. 267 (1976). 19 clark c. havighurst, foreword, 35 law & contemp. probs. 229 (1970). 20 id. 21 rick j. carlson, health manpower licensing and emerging institutional responsibility for the quality of care, 35 law & contemp. probs. 849 (1970); milton i. roemer, controlling and promoting quality in medical care, 35 law & contemp. probs. 284 (1970); william worthington & laurens h. silver, regulation of quality of care in hospitals: the need for change, 35 law & contemp. probs. 305 (1970). for an excellent account of the evolution of quality oversight over the twentieth century, see jost, supra note 1, at 827-41. 3312013 indiana health law review example, several articles from the mid-1970s examined the role of professional standards review organizations (psros) in controlling costs and ensuring the quality of hospital care delivered to medicare beneficiaries; an article by professors clark havighurst and james blumstein explicitly considered the balancing of cost and quality concerns within this framework. 22 in the early 1980s, medicare adopted a prospective payment system under which it paid hospitals a fixed amount for each patient admission, providing a financial incentive to hospitals to reduce costs per admission; several law review articles, including one by professor wendy mariner, considered the quality implications of this new approach to financing care. 23 an article from the mid-1980s considered the tensions between cost containment efforts and the application of quality standards in medical malpractice litigation.24 these articles evidenced a growing interest among the legal academic community in mechanisms for ensuring health care quality in a rapidly changing health care world. ii. the last quarter century of health care quality law and policy in some ways, the last twenty-five years of health care quality law and policy could be viewed as an extension of the previous one hundred. medical malpractice liability and professional licensing continued their roles as qualitycontrol mechanisms, although their effectiveness was widely questioned. and health law scholarship continued to devote significant attention to the tensions between quality 22 john r. ball, psro an alternative to the medical malpractice system as a quality assurance mechanism, 36 md. l. rev. 566 (1977); cedric c. chao, cost and quality control in the medicare/medicaid program: concurrent review, 11 harv. c.r.-c.l. l. rev. 664 (1976); clark c. havighurst & james f. blumstein, coping with quality/cost trade-offs in medical care: the role of psros, 70n.u.lrev.6(1976). 23 wendy k. mariner, prospective payment for hospital services: social responsibility and the limits of legal standards, 17 cumb. l. rev. 379 (1987). 24 e. haavi morreim, cost containment and the standard of medical care, 75 calif. l. rev. 1719 (1987). 332 vol. 10.2 donabedian's legacy and cost controls; while articles from the 1970s discussed psros and articles from the 1980s discussed medicare's prospective payment system, articles from the 1990s examined the quality concerns associated with the era's rapidly proliferating managed care organizations. 2 5 in other ways, however, both the nature of quality concerns and the legal and policy tools used to address them have evolved considerably in the last twenty-five years. this evolution can be traced to earlier developments in the medical field. a leading quality expert, david eddy, characterizes the medical world through much of the twentieth century as one in which it was often assumed that "through the rigors of medical education, followed by continuing education, journals, individual experiences, and exposure to colleagues, each physician always thought the right thoughts and did the right things."26 if training and professional interactions generally result in physicians doing "the right things," then licensure will go far in ensuring quality, and the liability system may provide the right incentives for high-quality care. in such a world, it makes perfect sense to focus on licensure and other peerreview based mechanisms, along with medical liability, to ensure that care is of acceptable quality. some individuals, however, recognized that quality concerns might extend beyond those associated with quackery. ernest codman, a boston surgeon, developed a system in the early 1900s for assessing surgical quality that he hoped would lead to improved care.27 but codman's data collection and analysis system was never put into 25 william s. brewbaker iii, medical malpractice and managed care organizations: the implied warranty of quality, 60 iaw & conietp. probs. 117 (1997); barry r. furrow, managed care organizations and patient injury: rethinking liability, 31 ga. l rev. 419 (1997); clark c. havighurst, making health plans accountable for the quality of care, 31galrev.587(1997); diane e. hoffmann, emergency care and managed care a dangerous combination, 72 wash. l rev. 315 (1997); william m. sage, enterprise liability and the emerging managed health care system, 60 iaw & convip.probs. 159 (1997). 26 david m. eddy, evidence-based medicine: a unified approach, 24 health aff. 9, 9 (2005). 27 michael l. millenson, demandingmedicalexcelernce 143 (1997). 3332013 indiana health law review widespread use, and it was not until much later that researchers began laying the foundation for today's quality improvement efforts. 28 in the 1950s, for example, paul lembcke created a system for conducting "medical audits" as a tool for assessing hospital quality. 29 the most influential work of this era, however, was avedis donabedian's pathbreaking 1966 article, evaluating the quality of medical care. it explained that quality could be assessed by looking at structures, processes, or outcomes, and then discussed the data and measurement issues that complicated efforts to engage in such assessments. 30 the work of these and other researchers was critical in developing the tools necessary to conduct systematic quality assessment. 31 a second, closely related force driving changes in quality-related law and policy was the growth in evidencebased medicine. rooted in the clinical research that began to accelerate in the 1960s, evidence-based medicine is a term applied to medical decision-making based on "good evidence of effectiveness and benefit."32 in the early 1980s, a 28 id. at 145. there were, of course, quality improvement initiatives other than codman's. see generally john m. luce, andrew b. bindman & philip r. lee, a brief history of health care quality assessment and improvement in the united states, 160 w.j. med. 263, 263-64 (1994) (discussing historical quality improvement efforts); millenson, supra note 27, at 142-47 (1997) (disussinghistoriclqualityimpmovementefforts). many early reform efforts focused on standard-setting, however, and did not benefit from the systematic study and assessment of quality that became more common late in the century. 29 see george a. silver, paul anthony lembcke, md, mph: a pioneer in medical care evaluation, 80 am. j. pub. health 342, 345-46 (1990) (discussing lembcke's contributions to the development of medical care evaluation techniques); millenson, supra note 27, at 15052 (describing lembcke's work). 30 avedis donabedian, evaluating the quality of medical care, 44 milbank memorial fund q. 166, 198-99 (1966). 31 see, e.g., robert h. brook & francis a. appel, quality-of-care assessment: choosing a method for peer review, 288 new eng. j. med. 1323 (1973) (discussing and applying quality evaluation methodologies). 32 eddy, supra note 26, at 14 (formally defining evidence-based medicine as a "set of principles and methods intended to ensure that to the greatest extent possible, medical decisions, guidelines, and other types of policies are based on and consistent with good evidence of vol. 10.2334 dona i iedian's leg(,acy variety of groups began to distill research results into guidelines for medical practice, and subsequently "more and more organizations began to apply evidence-based methods to their work."33 once established, guidelines had the potential both to promote the diffusion of evidencesupported high-quality treatment practices, and to facilitate assessment of health care quality based on evidencesupported standards. as research on health care quality continued into the 1990s, a related but distinct health care issue captured the attention of legal and medical scholars, medical professionals, and the public: medical error. medical error had been a topic of both legal and medical research before this period; professor furrow's 1981 article on the use of malpractice law to address medical error, for example, drew on several studies that had been published within the previous decade. 34 and articles on medical error appeared in medical journals even earlier in the century. but many of these articles focused on specific sources of error in diagnosis and testing procedures, rather than engaging in broader examinations of medical error.35 effectiveness and benefit"); gordon guyatt et al., evidence-based medicine: a new approach to teaching the practice of medicine, 268 jama 2420, 2420 (1992) (noting that a paradigm shift "involv[ing] using the medical literature more effectively in guiding medical practice" had foundations "in developments in clinical research over the last [thirty] years"). 33 eddy, supra note 26, at 12. 34 see furrow, supra note 15, at 7 nn. 1-4. 35 a medline review of pre-1970 titles containing the terms "error" or "iatrogenic" turned up only a few titles that seemed to refer to broader studies of medical error. see w.m. bartlett, diagnostic and therapeutic errors: a study of the causes of error in 500 clinical and necropsy records, 38 j. med. ass'n ga. 331 (1949); delay in recognizing cancer studied: iatrogenic or patient failure?, 197 jama 26 (1966); s.f. harkness, the hospital staff and iatrogenic morbidity and mortality, 57 j. am. osteopathic ass'n 305 (1958); d. zeman, the nature of medical error; a study in applied medical history, 4 j. chronic diseases 648 (1956); george l. saiger, observations on the probability of error in medical diagnosis, 56 annals internal med. 860 (1962) ("[aln analysis of how the probability of a diagnostic error can be measured or controlled when population values are known."). 3352013 indiana health law review in the latter part of the twentieth century, by contrast, a broad focus on medical error became more common. the now widely cited harvard medical practice study made headlines in 199136 by establishing the prevalence of adverse events, including negligent adverse events, in new york hospitals. 37 professor lucian leape published a classic article describing the causes of errors and approaches to error prevention in 1994.38 in 1999, the institute of medicine published to err is human,39 extrapolating from previous studies to suggest that the number of americans who die from medical errors in a year may be between 44,000 and 98,000, and that more people die annually from medical errors than from car accidents or breast cancer. 40 these startling statistics made newspaper front pages across the country, 41 and the report has now been cited many thousands of times.42 academic law journals followed 36 see hospital care hurts 4% of patients: study, chicago suntimes, feb. 7, 1991, at 28. 37 see troyen a. brenan et al., incidence of adverse events and negligence in hospitalized patients: results of the harvard medical practice study, 324 new eng. j. med. 370 (1991) (reporting results on rates of adverse events and negligence among new york hospitals in 1984); lucian leape et al., the nature of adverse events in hospitalized patients: results of the harvard medical practice study ii 324 new eng. j. med. 377 (1992) (examining adverse events in more detail). 38 lucian l. leape, error in medicine, 272 jama 1851 (1994). 39 inst. of med., to err is human: building a safer health system (1999) (linda t. kohn, janet m. corrigan & molla s. donaldson, eds.). 40 id. at 1. 41 see, e.g., bob davis & julie appleby, medical mistakes 8th top killer, usa today, nov. 30, 1999, at al; lauran neergaard, errorprone medicine study: mistakes kill tens of thousands of people a year, orlando sentinel, nov. 30, 1999, at al; robert pear, group asking us. for new vigilance in patient safety, n.y. times, nov. 30, 1999, at al. 42 google scholar suggests that the report has been cited more than 9500 times. see, e.g., steven h. woolf, patient safety is not enough: targeting quality improvements to optimize the health of the population, 140 ann. internal med. 33, 33 (2004). vol. 10.2336 donabedian's legacy the trend by publishing a series of articles on medical error." the institute of medicine's committee on the quality of health care in america followed up on to err is human two years later with a second report that took a broader look at quality in the health care system: crossing the quality chasm.44 beginning with the words, "the american health care delivery system is in need of fundamental change," the report reviews evidence of widespread quality deficits and makes recommendations for quality improvement. 45 the report does not seem to have had as significant an impact as to err is human. one explanation is its lack of the previous report's eye-catching mortality statistics. another is that by the time the report was published, health care quality and its improvement were already so clearly on the agenda or at least the radar screen of health professionals, researchers, and scholars. 46 research on quality assessment, the growth of evidencebased medicine, and concerns about changes within the health care system47 all contributed to a rapidly-expanding body of empirical research in the latter part of the 20th century. studies documenting deficiencies in care were 43 see, e.g., melissa chiang, promoting patient safety: creating a workable reporting system, 18 yale j. on reg. 383 (2001); joan h. krause, medical errors as false claims, 27 am. j.l. & med. 181 (2001); brian a. liang, the adverse event of unaddressed medical error: identifying and filling the holes in the health care and legal systems, 29 j.l. med. & ethics 346 (2001). work on medical errors continues to be published. see, e.g., michelle m. mello et al., who pays for medical errors an analysis of adverse event costs, the medical liability system, and incentives for patient safety improvements, 4 j. empirical legal stud. 835 (2007) [hereinafter mello et al.]. 4 inst. of med., crossing the quality chasm: a new health system for the 21st century (2001) [hereinafter inst. of med.]. 45 id. at 1. 46 see generally millenson, supra note 27, at 362 (describing attention to quality issues in the clinical literature in the mid-1990s). 47 a 1973 medical journal article referred to "public pressure and recent congressional legislation" legislation related to psros as a reason for increased attention to quality assessment. brook & appel, supra note 31, at 1323. 2013 337 indiana health law review published in the 1970s and 1980s. 48 professor donabedian's work on health care quality was widely published in the 1980s, 4 9 and by the end of the decade, numerous articles discussing health care quality had appeared in medical journals.50 in the 1990s, there was a steady flow of articles reporting the results of quality studies, while numerous commentators drew attention to the need for further research and the development of strategies to address deficiencies. 51 it was not just researchers who were interested in analyzing data on quality. by the early 1990s, continuous quality improvement and total quality management techniques had reached the health care industry. managers in health care organizations had begun to systematically 48 see eddy, supra note 26, at 10 (discussing john wennberg's work on geographic variations in health care delivery and rand studies from the 1980s "showing that large proportions of procedures being performed by physicians were considered inappropriate even by the standards of their own experts"). 49 see, e.g., avedis donabedian, the quality of care: how can it be assessed?, 260 jama 1743 (1988); avedis donabedian, quality assessment and assurance: unity of purpose, diversity of means, 25 inquiry 173 (1988). 50 see, e.g., r.w. dubois et al., hospital inpatient mortality: is it a predictor of quality, 317 new eng. j. med. 1674 (1987). 51 see, e.g., john z. ayanian et al., quality of care by race and gender for congestive heart failure and pneumonia, 37 med. care 1260 (1999); david blumenthal, the future of quality measurement and management in a transforming health care system, 278 jama 1622 (1997); mark r. chassin, assessing strategies for quality improvement, 16 health aff. 151 (1997); mark r. chassin, robert w. galvin & the national roundtable on health care quality, the urgent need to improve health care quality, 280 jama 1000 (1998); maria a. friedman, issues in measuring and improving health care quality, 16 health care financing review 1 (1995); stephen f. jencks et al., quality of medical care delivered to medicare beneficiaries: a profile at state and national levels, 284 jama 1670 (2000); mark a. schuster, elizabeth a. mcglynn & robert h. brook, how good is the quality of health care in the united states?, 76 the milbank q. 517 (1998); bryan j. weiner, jeffrey a. alexander & stephen m. shortell, leadership for quality improvement in health care: empirical evidence on hospital boards, managers, and physicians, 53 med. care res. & rev. 397 (1996). for a systematic review of quality articles from this period, see inst. of med., supra note 44, at 242-49. vol. 10.2338 i)onabedian's legacy collect and assess quality-related data within their own institutions.5 2 improved analytical techniques and data processing abilities,53 the ever-present concerns that cost controls would threaten quality, 51 and a vision of the future that involved quality-based competition55 have all been cited as contributors to the sharpening focus on quality issues. twenty-five years ago, in 1987, two articles in the health policy journal health affairs used the word "quality" in their titles, and one of these articles was really about physician supply.56 between 1987 and 1996, just over two percent of titles included the term "quality."5 7 between 1997 52 see donald m. berwick & marian g. knapp, theory and practice for measuring health care quality, health care fin. rev. 49 (1987); glenn laffel & david blumenthal, the case for using industrial quality management science in health care organizations, 262 jama 2869 (1989); jost, supra note 1, at 838-39 (discussing origins of total quality management and its application to health care); millenson, supra note 27, at 244-67 (chronicling providers' internal quality improvement efforts during the 1980s and 1990s). 53 see jost, supra note 1, at 836-37 (discussing impact of improved information technologies); kristin madison, regulating health care quality in an information age, 40 u.c. davis l. rev. 1577 (2007) (discussing impact of improved information technologies). 54 inst. of med., supra note 44, at 231 (pointing to concerns that new organizational structures and reimbursement strategies might sacrifice quality in an effort to control costs as motivating increased attention to quality issues); timothy stoltzfus jost, regulatory approaches to problems in the quality of medical care: diagnosis and prescription, 22 u.c. davis l. rev. 593, 593-94 (1989) (attributing the "renewed focus on quality assurance" of the late 1980s to "[s]trategies developed in the mid-1980s for coping with medical cost escalation, such as diagnosis-related-group prospective payment, health maintenance organizations (hmos), and gate-keeper managed care arrangements"). 55 troyen a. brennan, improving the quality of medical care: a critical evaluation of the major proposals, 10 yale l. & pol'y rev. 431, 436 (1992). 56 robert e. patricelli, employers as managers of risk, cost, and quality, 6 health aff. 75 (1987); ira m. rutkow, surgical operations and supply: assessing future quality, 6 health aff. 82 (1987) (discussing physician supply and surgical operations). 57 as of march 30, 2013, an "advanced search" completed on the health affairs website shows that when the search is restricted to the years 1987 and 1996, with no further restrictions on article content, 1371 articles are found. further restricting the search to include only 2013 339 indiana health law review and july 2012, that percentage more than doubled to over four and a half percent.5 8 over the last quarter century, quality has come to occupy an increasingly prominent position on the agenda of providers, researchers, and policymakers. what did this shift mean for health care law in the last quarter century? the 19th century tools for quality control, licensure and tort liability, are still around, but much policymaker and scholarly effort has been directed at finding ways to improve their usefulness in ensuring health care quality.59 for example, policymakers sought to improve peer review and professional discipline mechanisms through the passage of the health care quality improvement act of 1986.60 legal scholars, meanwhile, sought to build a foundation for medical liability reform by carefully analyzing the relationship between the liability system and quality.61 but the quality revolution also launched a new line of thinking among legal scholars about ways of ensuring high quality care. one of the authors in the 1970 issue of law and contemporary problems, rick j. carlson, foreshadowed later scholarship in the area by referencing donabedian's titles including the word "quality" returned 28 articles, which is two percent of 1371. 58 a search using the "advanced search" function on the health affairs website found 5222 articles published between 1997 and july 2012, of which 240 included the word "quality" in their titles. 59 see kristin m. madison, from hcqia to the aca: the evolution of reporting as a quality improvement tool, 33 j. legal med. 63, 65-67 (2012) (describing historical concerns about licensing and peer review as tools for ensuring quality). 60 see id. at 67-68 (describing health care quality improvement act of 1986); health care quality improvement act of 1986 (hcqia), 42 u.s.c. § 11101. 61 see, e.g., brennan, supra note 55; david a. hyman & charles silver, the poor state of health care qualityin the us.: is malpractice liability part of the problem or part of the solution, 90 corneil rev. 893 (2005); michelle m. mello & troyen a. brennan, deterrence of medical errors: theory and evidence for malpractice reform, 80 tex l rev. 1595 (2001); mello et al, supra note 43; william m. sage, kathleen e. hastings & robert a. berenson, enterprise liability for medical malpractice and health care quality improvement, 20alvij.l&med. 1(1994). vol. 10.2340 donabedian's legacy work on health care quality6 2 and then dividing "health care system quality controls" into input-based controls such as traditional licensure and accreditation standards, processbased controls such as peer review and professional discipline, and output-based controls. 63 he then suggested that most input-based controls involve "at best, conjectures about what kinds of inputs into a black box will yield good results," and that "[w]hen a more direct means of assessing health care outcomes is developed, the utility of their continued use is called into question."64 he proposed ''measuring actual health care outcomes against scientifically derived standards of outcomes," and using the results as a basis for pursuing actions against providers. 65 carlson's work, published when quality outcome measures were in their infancy, raised important questions about the future of health care regulation in a world in which such information became widely available. more than fifteen years after the publication of carlson's article in other words, just over twenty-five years ago provider-specific outcome measures did become more widely available. in 1986, the federal government released mortality statistics for individual hospitals nationwide, garnering media coverage across the country.66 the same year, the pennsylvania legislature passed legislation mandating quality reporting within the state.67 a few years later, the independent agency created by pennsylvania's legislation began to release hospital-specific report cards; in 1992, it began to report on the outcomes of individual heart surgeons. 68 thus, beginning in the mid-1980s, reporting gave the public a small window into health outcomes at the same time quality issues were commanding the attention of researchers, administrators, and providers. 62 see carlson, supra note 21, at 859 n.34. 63 id. at 862, figure 1. 64 id. at 859-60. 65 id. at 861. 66 see madison, supra note 59, at 72 (describing the release of hospital mortality statistics). for a discussion of the history of quality reporting, see id. at 69-74, 76-80. 67 id. at 72-73. 68 id. at 73-74. 2013 341 indiana health law review as the quality movement became firmly entrenched in the late 1980s and 1990s, health law scholars turned their attention to its implications for the law. in 1989, barry furrow effectively captured the rapidly evolving health care quality world with an article entitled "the changing role of the law in promoting quality in health care: from sanctioning outlaws to managing outcomes."69 drawing on donabedian's work, the article contrasts the traditional focus on "bad medicine" provided by "bad doctors," the sort combated with malpractice cases and professional discipline, with the trend toward institutional quality controls and greater attention to health outcomes. it proposes a variety of government reforms intended to support this evolution, including data mandates that would contribute to the development of accurate outcome data and the tying of financial incentives to health outcomes. 70 this article was one of the earliest of several articles that analyzed the implications of the increasing availability of health quality data for quality improvement, quality regulation, and public policy more generally.71 on the whole, these articles offered optimistic views on the implications of quality measurement for quality regulation and improvement. at the same time, they generally acknowledged the limitations of measurement as a quality tool. in a thoughtful and comprehensive 1988 article on quality regulation, professor jost explained that although markets could be a mechanism for assuring quality, they required well-informed consumers to function 69 barry r. furrow, the changing role of the law in promoting quality in health care: from sanctioning outlaws to managing outcomes, 26 hous. l. rev. 147 (1989). 70 see id. at 186-88. 71 see, e.g., david a. hyman & charles silver, you get what you pay for: result-based compensation for health care, 58 wash. & lee l. rev. 1427 (2001); john v. jacobi, patients at a loss: protecting health care consumers through data driven quality assurance, 45 u. kan. l. rev. 705 (1997); maxwell j. mehiman, assuring the quality of medical care: the impact of outcome measurements and practice standards, 18 l. med. & health care 368 (1990); william m. sage, regulating through information: disclosure laws and american health care, 99 colum. l. rev. 1701 (1999). 342 vol. 10.2 donabedian's legacy effectively, and consumers faced considerable difficulty in becoming well-informed about quality.72 he suggested that while consumer groups offered comparative quality information for some products, such information would be unlikely to become widespread in the health care market, due in part to the information's high costs and public good nature. 73 while insurers and employers had begun to take an interest in quality, their primary interest was cost, not quality, and they faced challenges in creating and distributing quality information. 74 in a later article, professor jost acknowledged that report cards might help solve the information problem, but then described the many difficulties of creating timely, accurate, relevant report cards that consumers would choose to use.75 he pointed out that managers also face difficulties in effectively using data.76 professor jost identified a few ways to respond to these problems. to facilitate the creation of quality measures, for example, medicare's peer review organization data "could also be made available to other payers or directly to consumers to assist in health care decisionmaking." 77 governments could facilitate the creation and dissemination of comparative quality information.78 as data become easier to collect and analyze, licensure boards could seek out "professionals that seem persistently to have bad outcomes." 79 in other words, the task of government should be to refine traditional quality control mechanisms such as licensure to take advantage of newly available quality data, while also building a stronger foundation for quality assurance through markets and management. all of this work preceded the publication of crossing the quality chasm. in the decade after the report's publication, 72 timothy stoltzfus jost, the nmsary and pioper role ofregulation to assure the quaklyofhealth cgu 25 hous. l. rev. 525, 558-63 (1988). 73 id. at 564. 74 id. at 566-67. 75 jost, supra note 1, at 851-55. 76 id. at 855-57. 77 jost, supra note 72, at 595. 78 jost, supra note 1, at 858. 79 jost, supra note 1, at 864-66. 2013 343 indiana health law review considerable effort was devoted to developing quality measures and putting them into regular use. five years after crossing the quality chasm, the institute of medicine published a report on performance measures entitled performance measurement: accelerating improvement.80 the national quality forum (nqf), which was conceived by a presidential quality commission in 1998 and became operational in 2000, brought together government policymakers, health plans, employers, research organizations, and others to develop consensus standards for performance measures.81 health care quality report cards produced by federal and state government agencies, stakeholder groups, health plans, and private entities became ubiquitous on the internet. 82 government and private initiatives to tie pay for physicians and hospitals to quality measures proliferated during the 2000s. 8 3 in short, the health care quality world has changed radically over the last twenty-five years. while the law and policy of much of the twentieth century seemed focused on eliminating quackery and remedying harm, quality improvement has now been widely embraced as a goal. quality measurement efforts over the last twenty-five years have not only helped to establish the need for quality improvement, but have also supplied important tools for achieving this end. legal scholars writing toward the beginning of this period recognized the importance of quality measurement, although they might not have fully anticipated the 80 inst. of med., performance measurement: accelerating improvement (2005). 81 presentation, kenneth w. kizer, the national quality forum and healthcare consumerism, federal trade commission (june 11, 2003), http://wwic.gov/ogchealthcauehearindocs/030611kizrkenethepdf kristin madison, the law and pohcy of health care quality reporting, 31 campbell l. rev. 215, 245 n.141 (2009). 82 see madison, supra note 81, at 217-20 (providing examples of quality reporting websites); madison, supra note 59, at 78-80 (detailing federal expansion of quality reporting). 83 see meredith b. rosenthal & r. adams dudley, pay-forperformance: will the latest payment trend improve care., 297 jama 740, 740 (2007) (describing pay-for-performance trend). 344 vol. 10.2 donabedian's legacy magnitude of the resulting changes. consumer reports, for example, overcame any hurdles posed by quality information's costs and public good characteristics, and is now publishing reports on heart surgeon and hospital quality.8 4 but there are many questions that remain about the effectiveness, unintended effects, and broader implications of the use of quality measures, including some concerns raised by jost and other scholars. as will be discussed in more detail in part iii, policymakers have taken some steps consistent with scholars' recommendations. for example, they have facilitated the development and dissemination of quality measures, and they have begun to tie pay to performance. other recommendations, such as the recommendation to incorporate quality measures into formal regulatory oversight mechanisms, have not yet been widely adopted. the question, then, is what this all means for the next quarter century of health care quality law and policy. iii. the next quarter century of health care quality law and policy: hopes and predictions a. predictions about quality law and policy i begin with a conservative prediction: the shift of focus from addressing incompetence to quality improvement is a permanent shift, or at least one that will persist over the next twenty-five years. as described in part ii, this shift was a function of the growth of evidence-based medicine, an improvement in quality measurement capabilities, and an acknowledgment of continuing deficiencies in health care quality. i see no reason for any of these three things to disappear anytime soon. i therefore predict that the health care system's commitment to quality improvement, with a heavy reliance on systematic quality measurement, will remain. one reason why this should be an uncontroversial prediction is the sheer volume of initiatives underway that 84 see doctors & hospitals, consumer reports, http://www. consumerepoirs.org/cheath/doct-and-hospitalstmdexhtm oast visited apr 6, 2013). 2013 345 indiana health law review either support or make use of quality measures. as numerous commentators have noted, quality measurement is a costly endeavor that could be greatly facilitated through the adoption of electronic medical records.85 in 2009, congress passed the health information technology for economic and clinical health (hitech) act, which created a program under which providers adopting electronic health records are eligible for billions of dollars in medicare and medicaid incentive payments.86 to qualify for these payments, providers must do more than just purchase electronic systems; they must become meaningful users of them. in 2011 and 2012, for example, systems must perform drug allergy checks and incorporate one clinical decision support rule; in 2012, users must submit electronically the relevant data for clinical quality measures. 87 proposed meaningful use rules for future years require more intensive use of records in ways that will set the stage for quality improvement.88 more than 100,000 providers have now registered for incentives, and adoption of electronic health records appears to be increasing rapidly, setting the stage for more intensive use of quality measures in the future.89 85 see, e.g., jost, supra note 1, at 864 (describing benefits of electronic records for quality measurement); madison, supra note 53, at 1597 (same); madison, supra note 53, at 1643 (calling for financial incentives to speed electronic medical record adoption for the purpose of facilitating quality measurement). 86 nicolas p. terry, certification and meaningful use: refraining adoption of electronic health records as a quality imperative, 8 ind. health l. rev. 43, 49-50 (2011). 87 david blumenthal & marilyn tavenner, the 'meaningful use" regulation for electronic health records, 363 new eng. j. med. 501, 502-503 (2010). 88 see, e.g., electronic health record incentive program stage 2, 77 fed. reg. 13,698, 13,736 (proposed march 7, 2012) (to be codified at 42 c.f.r. pts. 412, 413 & 495) (describing record system features required to earn an incentive payment, such as the ability to generate a list of patients with a specific condition or the ability to send out appropriate reminders to patients). 89 david blumenthal, implementation of the federal health information technology initiative, 365 new eng. j. med. 2426,2427-28(2011). 346 vol. 10.2 donabedian's legacy quality measurement and reporting have also expanded in ways that increase their usefulness for providers, payers, patients, and others. the national quality forum has now endorsed more than 700 performance measures in areas ranging from patient safety to cardiovascular care to surgical care to preventive care.90 numerous states have mandated public reporting of hospital-specific infection rates in the last few years.91 the federal government has also significantly expanded its public reporting initiatives. the department of health and human services' (hhs) hospital compare website, for example, added mortality information in 2007, patient experience measures in 2008, and outpatient and emergency care measures in 2010.92 if recent activity is any guide, we will be seeing many more quality measures in use in the near future. the best place to search for clues about the future of quality regulation, however, is probably the patient protection and affordable care act of 2010.93 it reinforces the view that quality measurement and improvement activities will not slow down anytime soon. the affordable care act devotes an entire title to quality issues: title iii, improving the quality and efficiency of health care. it requires the adoption of a national strategy to improve 90 national quality forum, nqf measure endorsement: 2012 mid-year review 1-2, (2012), available at http://www.qualityforumrgf workarea/iinkitaspxlinkldentifier-id&itemid71437 (last visited apr. 6, 2013). 91 see state legislation & initiatives on healthcare-associated infections, committee to reduce infection deaths (updated oct. 2011), availableathttp//hospitainfctionorglegislationshtmll astvisitedapr. 1,2013). 92 press release, u.s. dep't of health & human serv., medicare enhances consumer information on hospital care (june 21, 2007), available at http://www.hhs.gov/news/press/2007pres/06/20070621a.html (last visited apr. 1, 2013); press release, u.s. dep't of health & human serv., new web site helps patients shop for hospital care based on quality and price (mar. 28, 2008), available at http://www.hhs. gov/news/press/2008pres/03/20080328a.html (last visited apr. 1, 2013); press release, u.s. dep't of health & human serv., important new data added to healthcare.gov to help americans understand the state of quality at america's hospitals (july 7, 2010), available at http://www. hhs.gov/news/press/2010pres/07/20100707h.html (last visited apr. 1, 2013). 93 patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010), amended by the health care and education reconciliation act of 2010, pub. l. no. 111-152, 124 stat. 1029 (2010). 3472013 indiana health law review health care quality.94 it calls for the development of new quality and efficiency measures, including outcome measures. 95 it imposes a general mandate for federal collection and reporting of quality data,96 and establishes specific reporting programs for entities such as long-term care hospitals and hospice programs, 97 as well as for physicians. 98 the affordable care act also mandates the sharing of medicare claims data with private entities for the purpose of facilitating the evaluation of "quality, efficiency, effectiveness, and resource use."99 this step responds to longstanding requests of employers and others to access this data, and partially addresses concerns that fragmented access to data holdings impede the creation and dissemination of reliable quality measures.100 94 patient protection and affordable care act § 3011, 42 u.s.c. § 280j (2012); report to congress: national strategy for quality improvement in health care, available at http://www.healthcare.gov/ law/resources/reports/quality03212011a.html (last visited apr. 1, 2013). 95 patient protection and affordable care act §§ 3013-3014, 42 u.s.c. § 299b-31 (2012). 96 patient protection and affordable care act § 3015, 42 u.s.c. § 280j-1 (2012). 97 patient protection and affordable care act § 3004, 42 u.s.c. §§ 1395ww(m) & 1395ww(j) (2012). 98 patient protection and affordable care act § 10331, 42 u.s.c. § 1395w-5 (2012). 99 patient protection and affordable care act § 10332, 42 u.s.c. § 1395kk (2012); availability of medicare data for performance measurement, 76 fed. reg. 76,567 (dec. 7, 2011) (codified at 42 c.f.r. pt. 401). 100 see madison, supra note 53, at 1642-43 (referring to employers' desire for data and arguing that federal data should be shared); mark schoofs & maurice tamman, in medicare's data trove, clues to curing cost crisis, wall st. j., oct. 25, 2010, http://online.wsj.com/article/ sb10001424052748704696304575538112856615900.html (last visited apr. 6, 2013) (describing a 1970s-era injunction limiting sharing of medicare claims data and recent efforts to fight it); press release, consumers' checkbook, consumer organization praises government's plans to release medicare data to help consumers, improve health care system (dec. 6, 2011), available at http://www.checkbook. org/press/doc/checkbook medicareclaims_%2odatapressrelease 12-6-11.pdf (describing new regulations governing medicare data sharing and critiquing their limitations). vol. 10.2348 donabedian's legacy the affordable care act also builds on the federal government's previous experiments in using financial incentives to promote health care quality.'(" it supplies parameters for a value-based purchasing program that ties hospital payment to quality measures, 102 reduces payments to hospitals in which patients suffer from unusually high levels of hospital-acquired conditions, 103 and provides for physician payment adjustments "based upon the quality of care furnished compared to cost." 10 4 it establishes a shared savings program that allows providers to financially benefit from medicare savings they obtain, but only if they attain a minimum level of performance on health care quality measures.105 it also requires that qualified health plans offered through the affordable care act's state health benefit exchanges make use of payment structures that reward quality.106 through all of these initiatives, the affordable care act continues the previous trajectory of federal involvement in quality improvement efforts. it strengthens the infrastructure for health care quality measurement and expands on previous programs to incentivize quality improvement. it embodies a long-term federal commitment to the systematic use of quality measures in an effort to improve quality. despite the political uncertainty over the long-term future of the affordable care act, there does not 101 see generally lyle nelson, lessons from medicare's demonstration projects on value-based payment, (congressional budget office, working paper no. 2012-02, 2012), available at http://www.cbo.gov/sites/default/files/cbofiles/attachmentawp2012-02_nelon meclicare vbp demonstmtions.pdf (describing medicare's value-based purchasing demonstration projects and analyzing their reported results). 102 patient protection and affordable care act § 3001, 42 u.s.c. § 1395ww (2012). 103 patient protection and affordable care act § 3008, 42 u.s.c. § 1395ww (2012). 104 patient protection and affordable care act § 3007, 42 u.s.c. § 1395w-4 (2012). 105 patient protection and affordable care act § 3022, 42 u.s.c. 1395jjj(b)(3) (2012). 106 patient protection and affordable care act §§ 1311(c)(1)(e), 1311(g)(1), 42 u.s.c. § 18031 (2012). 3492013 indiana health law review seem to be any concerted effort to abandon this commitment. as the federal involvement in quality measurement and reporting efforts grows, the direction of state and thirdparty involvement in similar quality initiatives is uncertain. federal programs have the potential to crowd out other programs, particularly in the reporting area. in 2011, the california hospital association announced its decision to withdraw its support for a multistakeholder organization that had been publishing california hospital report cards for several years, citing, among other factors, the public availability of data through the federal hospital compare website.107 in ohio, the ohio hospital association has supported a bill that would end state reporting, again citing the fact that quality data is available at hospital compare. 08 the author of a recent study on state infection reporting suggests that "states slowed down their [public reporting] efforts because people assumed that this is a cause that's going to be taken on by medicare."109 at the same time, however, there is reason to expect continued and perhaps even expanding state and thirdparty involvement in quality measurement-based initiatives in the future. this is most obviously the case in measure development, where provider groups will likely want to 107 stephanie teleki & maribeth shannon, in california, quality reporting at the state level is at a crossroads after hospital group pulls out, 31 health aff. 642, 642 (2012) ("in late 2011 the california hospital association's board of trustees voted to withdraw the organization's support from the initiative, noting declining value to users, costs of data collection, and the fact that the center for medicare and medicaid services' hospital compare website obviated the need for the state-based reporting effort."); id. at 643 (describing the hospital association's comments in more detail). 108 ben sutherly, hospitals support repeal of data rule, dayton daily news, dec. 4, 2011, http://www.daytondailynews.com/news/ news/state-regional/hospitalssupport-repeal-of-data-rule1/nmxcx/ (last visited apr. 6, 2013). 109 kevin b. o'reilly, only 14 states post hospital data on surgical site infections, am. med. news, april 2, 2012, http://www.amaassn.org/amednews/2012/04/02/prsbo4o2.htm (last visited apr. 6, 2013) (statement of martin a. makary). 350 vol. 10.2 donabedian's legacy continue or expand on their current involvement""i in order to shape the measures that will be used for their evaluation or compensation. payers of all sorts will also want to remain involved in developing quality measures and incentive programs, given the demands placed on them by customers, beneficiaries, and others. state medicaid programs, for example, have experimented with a variety of pay-forperformance programs,'11 and private payers are likely to continue to tie pay to quality as well. state and third-party involvement has the potential to grow in the reporting area, too. increased federal involvement in quality measurement and reporting may reduce the incremental value of other report cards, but it may also reduce their costs. federal support may therefore make public reporting a viable proposition for a larger cross-section of organizations, allowing them to turn their attention to the task of aggregating and presenting federally-developed quality measures in ways well-suited to the needs of their targeted users. 112 more widely available, more tailored, and/or more polished presentations of quality data might help to address the lack of consumer engagement that has hindered reporting's effectiveness as a quality improvement tool. a 2007 california survey found that less than a quarter of 110 see 2012 physician quality reporting system (physician quality reporting) measures list, ctr. for medicare & medicaid serv., (dec. 23, 2011) http://www.cms.gov/medicare/quality-initiativespatient-assessment-instruments/pqrs/downloads/2012 physqualrptg implementationguidemeasureslist_01162012.zip (last visited apr. 6, 2013) (listing federal physician quality reporting measures and their developers, including organizations such as the american academy of dermatology and the american heart association). 11 see, e.g., judith graham, ohio medicaid program raises stakes for nursing homes, kaiser health news (aug. 14, 2012), http://www.kaiserhealthnews.org/stories/2012/august/15/ohio-medicaidnursing-homes.aspx (last visited apr. 6, 2013) (describing an ohio medicaid pay-for-performance program for nursing homes). 112 see sutherly, supra note 108 (stating that an opponent of the bill that would terminate ohio's reporting program "said the ohio website is easier to use than the federal website"); madison, supra note 81, at 251 (discussing states' potential roles in publicizing federal quality data). 2013 351 indiana health law review individuals had seen physician quality ratings, and that a similar percentage had seen hospital ratings.113 many individuals are not aware of the existence of quality ratings, and ratings can sometimes be difficult to find. the affordable care act's state health benefit exchanges offer an opportunity to address this problem.114 they were conceived primarily as a way to facilitate access to insurance coverage, and the affordable care act mandates the dissemination of quality information related to health insurance plans.115 the exchanges' websites could, however, evolve into a broader platform for disseminating information to patients and consumers about health, health care, and health care providers, regardless of whether they turn to the exchange for coverage. the more frequently that the public accesses state exchanges through the internet, the more likely they are to become aware of the quality information that is available. this broader use of exchanges is more a hope than a prediction, given exchanges' early stage of development and their controversial nature. nevertheless, the point remains that there will be room for nonfederal involvement in expanding public reporting. one final prediction is that consumer use of quality reporting will grow. surveys suggest that the use of quality information increased only slightly through the 2000s.116 much of the growth in federal public reporting, however, 113 cal. healthcare found., just looking: consumer use of the internet to manage care 10 (2008), available at http://www.chcf.org/resources/download.aspx?id=%7ba4dbb4f4-24al448c-b7a4-d7f1f27032ca%7d (last visited apr. 6, 2013). the survey found that 2 3% of respondents saw hospital rating information, 2% considered a change of provider based on the rating, and 1% actually made a change; the similar statistics for physicians were 22%, 5%, and 2%. id. 114 patient protection and affordable care act § 1321, 42 u.s.c. § 18041 (2012). 115 patient protection and affordable care act §1311(c)(1)(h), 42 u.s.c. § 18031 (2012). 116 henry j. kaiser family found., 2008 update on consumers' views of patient safety and quality information 6 (2008), http://www.kff.org/kaiserpolls/upload/7819.pdf (showing that 15% of survey respondents in 2000 and 20% of respondents in 2008 had seen quality data on hospitals). 352 vol. 10.2 donabedian's lecacy has occurred in the last five years. 117 moreover, as the population ages, a higher proportion of health care users, and a higher proportion of their caregivers, will have online access and experience searching the internet for information. a national survey found that as of 2012, only 53% of adults age 65 or over used the internet a significant jump from 2011, when only 41% did. 118 by contrast, over 90% of adults ages 18 to 49 used the internet in 2012.119 twenty-five years from now, as these younger adults become more engaged with the health system as caregivers and patients, they are likely to be more proactive than today's older adults in searching for quality information. admittedly, reporting will always remain a more important tool for providers, payers, and regulators, than for patients, given the many barriers patients face in using it effectively. 120 in addition, consumer use may drop if reporting or other quality improvement measures succeed in closing performance gaps. given the pace of medical progress, however, it seems that there should always be new areas for assessment. b. hopes for quality la w and policy parts i and ii of this essay illustrated how much the health care quality world has evolved over the past century, focusing in particular on the trend toward quality measurebased oversight mechanisms; part iii.a predicted that this trend would continue. this essay has not devoted much attention, however, to the question of whether the trend is a salutary one. in theory, the trend has the potential to greatly enhance quality, but in practice, its impact has been 117 see u.s. dep't of health and human serv., supra note 92. 118 kathryn zickuhr & mary madden, pew research center's internet & american life project, older adults and internet use 4 (2012), available at http://pewinternet.org/reports/20 12/older-adultsand-internet-use.aspx (last visited apr. 6, 2013). 119 id. at 6. 120 madison, supra note 81, at 226-33 (describing barriers to report cards' use and usefulness). 2013 353 indiana health law review less clear.121 quality measures may be ignored or inaccurate or misused. if incorporated into reporting or incentive programs, they may encourage providers to avoid sick patients, exacerbate disparities in provider quality and patient health, or divert provider and regulator attention from steps more likely to achieve quality goals.122 or they may simply be absent, leaving a blank or incomplete picture of treatment quality for a particular condition, provider, or patient group. all of these possibilities are worrisome, and the challenges in responding to them are considerable. i will not be able to address these concerns in this essay, but i will say that i remain hopeful that the continuing emphasis on quality measurement and reporting will benefit patients in the long run. in the remainder of this essay, i describe four more specific hopes for the future of health care quality law and policy. 1. improvement in quality measurement capabilities for quality measurement to benefit a broader group of patients, quality measurement capabilities will need to improve significantly. toward this end, it will be important to expand the data available for use in calculating quality measures. the affordable care act provision that allows for the sharing of medicare data with outside organizations is a significant step, but i hope that even more will be done to 121 compare maureen a. smith et al., public reporting helped drive quality improvement in outpatient diabetes care among wisconsin physician groups, 31 health aff. 570 (2012) with andrew m. ryan, brahmajee k. nallamothu & justin b. dimick, medicare's public reporting initiative on hospital quality had modest or no impact on mortality from three key conditions, 31 health aff. 585 (2012). 122 see, e.g., rachel m. werner, l. elizabeth goldman & r. adams dudley, comparison of change in quality of care between safety-net and non-safety-net hospitals, 299 jama 2180 (2008) (concluding that "[slafety-net hospitals tended to have smaller gains" and that therefore "[an incentive system based on these measures has the potential to increase disparities among hospitals"). for a discussion of previous studies on the impact of quality reporting, see madison, supra note 81, at 220-36. vol. 10.2354 donabedian's likgacy enlarge the data pool so that we can maximize the accuracy and reliability of measurement. professor harold luft recently proposed a means of accomplishing this goal, and it seems to be a step in the right direction.123 i also hope that we will be able to develop, systematically collect, and use better measures of health outcomes. because of the need to take into account differences in underlying patient characteristics, outcomes can be very difficult to measure properly. on the other hand, outcome measures are critically important to patients, and their use may encourage quality-enhancing innovation more than process measures would. outcome measures should include more than just mortality, although surely patients care about that, and more than the readmissions and complications data currently found on the federal hospital compare website.124 they should also include measures that indicate the extent to which treatment has improved patients' quality of life, or slowed its deterioration. the patient survey data on hospital compare provides one example of this sort of indicator: a question about whether hospital patients' pain was always controlled.125 broader surveys could be used to capture additional information about patients' perceptions of their own quality of life. data could also be collected on more objective measures, such as patients' ability to walk or prepare meals. some measures along these lines already exist, but they are often not systematically collected and recorded.126 work to develop outcomes measures is 123 harold s. luft, advancing public reporting through a new aggregator' to standardize data collection on providers' cost and quality, 31 health aff. 619 (2012). 124 see find hospitals: hospital compare, ctr. for medicare & medicaid serv., http://www.hospitalcompare.hhs.gov (last visited apr. 6,2013). 125 see id. (reporting "patient survey results" for each hospital in the website database). 126 see sidney t. bogardus et al., what does the medical record reveal about functional status, 16 j. gen. internal med. 728 (2001) (finding that most medical records lacked documentation of patients abilities' to engage in activities of daily living). 3552013 indiana health law review underway, 127 but much remains to be done. i therefore predict that the focus on outcomes will increase in the next twenty-five years, but hope for even more. i hope that wellconstructed patient outcome measures become ubiquitous. i hope that research on quality measurement's impact on quality will continue to accumulate, and that it will begin to dig deeper. many recent studies evaluate the impact of entire reporting programs in the aggregate; some find an effect, some do not.128 while differences in study methodologies may explain the mixed results, it seems likely that differences in program characteristics would matter too. it would be nice to begin to sort out the factors that determine report cards' effects. i would like to know more about the effects of incorporating patient experience measures into report cards, for example. 129 the principle of patient-centeredness has captured the attention of the health policy community, 130 and patient experience measures, such as patient assessment of whether a provider has communicated well, allow for its evaluation. there are many good reasons to support the use of experience measures. they represent dimensions of quality that are important to patients but too often overlooked. patients may understand them better than technical quality measures, and may be more likely to seek them out. on the other hand, such measures might divert patient, provider, and regulator attention from technical clinical quality measures that have a tighter link with health outcomes. but do they? does the inclusion of patient experience 127 see, e.g., nqf: patient outcomes measures, national quality forum, http:/www.quaityfbrumorgpjectatient outcome measuresaspx last visited apr. 6,2013). 128 see madison, supra note 81. 129 for more discussion of issues raised by patient experience reporting, see madison, supra note 81, at 229-33. 130 see generally report to congress, supra note 94 (identifying "making health care more patient-centered" as a national aim); hospital compare, medicare.gov, http://www.medicare.gov/hospitalcompare/ (last visited apr. 6, 2013) (placing "patient survey results" in a prominent position adjacent to "general information" in hospital search results). vol. 10.2356 donabedian's legacy measures in measurement, reporting, or incentive programs improve technical quality, or undermine it?131 does it increase the costs of care, as it might if providers try to satisfy patient demands by offering more services? 132 these are just a few of many questions that remain unanswered about the intended and unintended effects of recentlydeveloped quality tools. i hope that the body of research on these tools will grow significantly over the next twenty-five years,133 creating the evidence base necessary to design effective oversight mechanisms. 2. consolidation-related improvements in quality another of my hopes is that the health care industry's trend toward consolidation will foster further growth in quality. from the 1990s through the mid-2000s, physicians 131 evidence on the link between various kinds of patient experience measures and technical quality measures is mixed. see, e.g., john t. chang, patients' global ratings of their health care are not associated with the technical quality of their care, 144 annals internal med. 665 (2006) (finding no relationship between technical quality measures and patients' assessments); thomas isaac et al., the relationship between patients' perception of care and measures of hospital quality and safety, 45 health services res. 1024 (2012) (finding a positive relationship between patient experience and technical quality measures); ashish k. jha et al., patients'perception of hospital care in the united states, 359 new eng. j. med. 1921 (2008) (showing a correlation between clinical quality measures and results on the hospital consumer assessment of healthcare providers and systems survey); joel m. kupfer & edward u. bond, patient satisfaction and patient-centered care: necessary but not equal, 308 jama 139 (2012) (concluding that the medical literature has not established a clear link between satisfaction surveys and the improvement of health outcomes). 132 see joshua j. fenton et al., the cost of satisfaction, 172 archives internal med. 405 (2012) (finding that "higher patient satisfaction was associated with less emergency department use but with greater inpatient use, higher overall health care and prescription drug expenditures, and increased mortality"). this result would be particularly problematic if the increased costs exceeded the monetized value of patients' increase in satisfaction. 133 of course, there is also a need, perhaps even a greater need, for more research on more traditional quality tools, such as medical licensure and malpractice liability. 2013 357 indiana health law review began to leave their traditional solo and two-person practices in favor of mid-sized practices and institutions like medical schools. 134 more recently, hospital employment of physicians has been increasing rapidly,135 a trend that may accelerate in response to the reforms embodied in the affordable care act. 136 to be eligible for the financial incentives available under the affordable care act's shared savings program, for example, providers must come together as "accountable care organizations" (acos) to take joint responsibility for the care of a group of medicare beneficiaries. 137 formal consolidation through employment relationships and the structures designed to permit coordinated care may signal the beginning of the end of the fragmentation that has made quality improvement so difficult in the past.138 greater integration expands the scope for internal quality management and monitoring through peer review mechanisms and management techniques, decreasing the importance of external oversight mechanisms such as professional disciplinary bodies. greater integration may also facilitate quality measurement. the limited number of patients that each physician sees creates a technical challenge for those seeking to compile accurate quality 134 allison liebhaber & joy m. grossman, physicians moving to mid-sized, single-specialty practices (tracking report no. 18, 2007), health systems change, http://www.hschange.com/content/941/ (last visited apr. 6, 2013). 135 jenny gold, hospitals lure doctors away from private practice, kaiser health news (oct. 13, 2010), http'/wwwkaiserhealthnewsorgl stores/2octobedl3/hospitalrlu-doctonaway-fmm-prvate-practice aspx (last visited arp. 6,2013). 136 j.d. harrison, health-care law driving doctors away from small practices, toward hospital employment, wash. post, july 19, 2012, http//artces-washingtonpostom/2012-07-196usiness/35489044 1-primar-caphysiiashealth-careformlaw-acountable-cae-organizations (last visited apr. 6, 2013). 137 patient protection and affordable care act § 3022, 42 u.s.c. 1395jjj (2012). 138 see generally the fragmentation of u.s. health care: causes and solutions (einer elhauge ed., 2010) (exploring the implications of fragmentation in the u.s. health care system). 358 vol. 10.2 donabedian's legacy measures for individual physicians. 139 if truly integrated organizations put in place effective clinical protocols and robust quality oversight mechanisms, however, then a patient's experience will depend less on the patient's idiosyncratic relationship with a single provider, than on the care system developed by the organization as a whole. technical quality ratings of the entire organization would then become nearly as meaningful to patients as ratings of a single practitioner and more reliable, given the broader patient base from which they draw. i hope that this hypothesis proves to be true, so that increased consolidation results in a more robust set of quality management tools, rather than merely impeding the competitive process that might otherwise result in better health care quality. 3. stronger external oversight mechanisms as parts ii and iii explained, quality measures are now deployed throughout the health care system. in the last twenty-five years, health care managers have begun to turn to quality measures to monitor care within their own institutions; consumers, to choose providers; and payers, to reward quality. interestingly, though, quality measures do not seem to have been incorporated into the more traditional mechanisms for responding to poor quality, tort liability and licensure. in the case of malpractice law, quality measures have proven to be an awkward fit. there may be a connection between quality measures and standards of care, in that clinical guidelines may shape both. previous authors have explored the relationship between practice guidelines and malpractice standards. 140 but ultimately, to win a 139 see timothy p. hofer et al., the unreliability of individual physician "report cards" for assessing the costs and quality of care of a chronic disease, 281 jama 2098 (1999). 140 see michelle mello, of swords and shields: the role of clinical practice guidelines in medical malpractice litigation, 149 u. pa. l. rev. 645 (2001); arnold rosoff, evidence-based medicine and the law: the courts confront clinical practice guidelines, 26 j. health pol. pol'y & l. 327 (2001); arnold j. rosoff, the role of clinical practice 2013 359 indiana health law review malpractice case, a patient must establish that a specific provider's services to the patient fell below the requisite standard. a provider's individual score on a quality measure cannot accomplish this task, because it says little about the care provided to a particular patient. it seems unlikely that a provider's score on a quality measure would have a significant impact on the outcome of malpractice litigation.141 there is more room for the use of quality measures, however, in activities undertaken by external oversight organizations. the joint commission, which accredits hospitals, has moved in this direction; in 2012, it began requiring hospitals to meet a target performance level on a subset of quality measures.142 medical specialty boards do not condition re-certification on physician performance as reflected in quality measures, but they do require physicians to participate in programs in which the physicians evaluate their own performance.143 state medical boards are currently moving toward maintenance-oflicensure requirements patterned after specialty boards' guidelines in healthcare reform: an update, 21 annals health l. 21 (2012). 141 see generally aaron s. kesselheim, timothy g. ferris & david m. studdert, will physician -level measures of clinical performance be used in medical malpractice litigation?, 295 jama 1831 (2006). 142 press release, the joint commission, joint commission annual report names top performing hospitals (sept. 14, 2011), available at httplanceyahoo.om/newsjont-commission-annual-iw-990486421.html (last visited apr. 6, 2013) ("beginning january 1, 2012, joint commission-accredited hospitals will be required to meet a new performance improvement requirement that establishes an 85 percent composite compliance target rate for performance on accountability measures."); see also madison, supra note 53, at 1605 (briefly describing earlier joint commission involvement in quality measurement activities). 143 see self-evaluation overview, american board of internal medicine, http://www.abim.org/moc/self-eval.aspx (last visited apr. 11, 2013) (describing evaluation requirements for maintenance of certification); christine k. cassel & eric s. holmboe, credentialing and public accountability: a central role for board certification, 295 jama 939, 940 (2006) (discussing relationship between credentialing and quality measures). vol. 10.2360 donabedian's legacy maintenance of certification requirements. 14 4 if states adopt the proposed framework, physicians seeking to renew their licenses would be required to use data to evaluate their practices.14 5 what state medical boards have not done is to systematically incorporate physicianspecific quality measures in their oversight processes. today, as in the past, board disciplinary actions are complaint driven. rather than engaging in regular monitoring of physician practice, boards respond to complaints that bring to their attention potentially problematic physician actions.146 i hope that medical boards will someday be able to use poor performance on quality measures to identify providers for whom closer scrutiny may be appropriate, much as the state of michigan requires an investigation in the wake of multiple malpractice payments. 147 it is true that many physicians would already be subject to such scrutiny through other forms of peer review (and perhaps public reporting), and that the number of physicians in this category is likely to expand as more physicians join larger institutions. increased medical board oversight, however, would be helpful in ensuring some level of scrutiny for physicians who fall through the cracks of these systems.145 for this hope to become reality, physician-specific quality metrics will have to be more fully developed, and medical boards will require more resources to engage in the reviews that would be triggered. 144 james n. thompson & lisa a. robin, state medical boards: future challenges for regulation and quality enhancement of medical care, 33 j. legal med. 93, 107 (2012) (describing performance in practice requirement of maintenance of licensure framework). 145 id 146 id. at 104. 147 mich. comp. laws § 333.16231 (2012). 148 cf jost, supra note 1, at 865 (suggesting that in using quality data to engage in regulatory functions, "licensure agencies should focus on those practitioners who are relatively free from managerial or market oversight"). 3612013 indiana health law review 4. systematic use of quality metrics in all healthrelated policies and programs the final hope i will address in this essay is that quality measures will be used not just in quality improvement initiatives, but in all policies and programs that have the potential to impact quality. quality measures may be adopted out of a general concern that quality might not be as good as it could be. a measurement program would then confirm the validity of the concerns, motivate remedial activities, and track whether the activities had been successful. quality measures could be used to test whether a new staff training program was able to increase the quality of care, for example. but measurement can also serve another purpose: it can track whether initiatives with other goals have influenced quality. all of these functions are at work in the affordable care act's shared savings program. as previously described, it allows health care providers to create acos that take responsibility for a defined group of medicare beneficiaries. 1 4 9 if an aco is able to reduce beneficiaries' costs of care below a specified level, it is entitled to keep a portion of the savings it achieves, in addition to receiving payment for the services it provides. 150 one major function of the program, then, is to provide a financial incentive to reduce program costs. but to take advantage of this incentive, acos must also meet the quality standards specified by the center for medicare and medicaid services (cms).151 the current standards incorporate 33 performance measures in areas such as preventive health, patient experience, and patient safety, 152 and cms expects to modify the standards over time to encourage continued 149 see patient protection and affordable care act § 3022, 42 u.s.c. § 1395jjj (2012). 15o see 42 c.f.r. § 425.10 (2012) (contours of program); 42 c.f.r. § 425.606 (2012) (shared savings formula). 151 42 c.f.r. § 425.500 (2012). 152 see rti international & telligen, accountable care organization 2012 program analysis (dec. 12, 2011), http://www.cms.gov/medicare/medicare-fee-for-service-payment/shared savingsprogramldownloads/acoqualitymeasures.pdf. 362 vol. 10.2 donabedian's legacy quality improvement.153 thus, the quality measures serve two roles in the shared savings program to ensure that acos do not reduce health care quality in their effort to save costs, and to promote health care quality improvement. ideally, any new regulation or program with the potential to significantly influence health care quality would be accompanied by a plan to measure its impact. measurement programs already in place may be sufficient for this purpose in some cases; in others, new measures may need to be crafted specifically for this purpose. a state considering expanding a non-physician's scope of practice, for example, might consider first putting in place a quality measurement program that would allow for evaluation of any quality effects of the change. i hope that as quality measurement tools become less costly, more accurate, and more comprehensive, regulators and policymakers will become more willing to experiment with initiatives that might pose a small risk to health care quality, but that have the potential to achieve other important policy goals, such as reducing cost or promoting access. iv. conclusion this essay has described the tremendous expansion in health care quality initiatives over the past century. while the rate of expansion may slow as we work to improve systems for quality measurement, my hope and prediction is that the focus on quality will remain. my fear is that it may not. even in an era of slowing rates of health care expenditure growth, 154 concerns about future spending seem to be intensifying. as medicare reform and the need for cost control come to dominate the public debate, and the institute of medicine's quality and safety reports begin to recede from memory, will attention to quality issues begin to wane? 153 42 c.f.r. § 425.500 (2012). 154 anne b. martin et al., growth in us health spending remained slow in 2010; health share of gross domestic product was unchanged from 2009, 31 health aff. 209 (2012) (documenting changes in health expenditures). 2013 363 364 indiana health law review vol. 10.2 in the past, efforts to reduce costs have been swiftly followed by renewed commitments to monitoring quality, and perhaps the next twenty-five years will be no different. hopefully, funding will continue to be directed toward initiatives that will allow us to assess any tradeoffs made between cost control and quality improvement, if indeed there are any. the last twenty-five years of progress in health care quality law, policy, and practice has built a strong foundation for further quality improvement, if we choose to pursue it. did legal education fail health reform: and how health law can help did legal education fail health reform? and how health law can help wendy k. mariner* i. introduction ...................................... 1 ii. the aca challenge was not an easy case ................ 3 iii. does legal education contribute to ineffectual scholarship or practice?. . . . . . . . . . . . . . . . . . . . . . . . . 11 iv. health law offers a model for rethinking legal education, at least in part.. .................... 23 v. a broader vision for health law .... ............ 32 i. introduction the challenges to the constitutionality of several provisions of the patient protection and affordable care act' (aca) should put an end to any question that health law is a field.2 in court, the issues were presented as * jd, llm, mph; edward r. utley professor of health law, boston university school of public health; professor of law, boston university school of law; professor of socio-medical sciences and community medicine, boston university school of medicine. this article was first presented as the mcdonald-merrill-ketcham memorial award lecture at indiana in april 2012. the author thanks all the participants in the anniversary conference for comments and suggestions. 1 see nat'l fed'n of indep. bus. v. sebelius, 132 s. ct. 2566 (2012). at least 28 cases challenged the individual mandate, the expanded eligibility requirements for medicaid, and/or the use of federal funds to subsidize insurance coverage of contraception or abortion in the patient protection and affordable care act of 2010, pub. l. 111-148, § 1501, 124 stat. 119, as amended by the health care and education reconciliation act of 2010, pub. l. 111-152, 124 stat. 1029. 2 several scholars have examined the nature of the health law field from different perspectives. see, e.g, george j. annas, health law at the turn of the century: from white dwarf to red giant, 21 conn. l. rev. 551 (1989); m. gregg bloche, the invention of health law, 91 calif. l. rev. 247 (2003); henry t. greeley, some thoughts indiana health law review questions of constitutional law, specifically congress's power to regulate commerce and to tax and spend for the general welfare.3 nevertheless, analyzing whether those powers encompassed the minimum coverage requirement (also known as the individual mandate) and the medicaid eligibility expansion necessitated more than passing knowledge of health care and health insurance. constitutional scholars suddenly had to be health law experts. the arguments and resulting opinions, however, reflect significant gaps in knowledge about health insurance and the health care system in general. this essay argues that this gap in knowledge matters and that it may offer lessons for improving legal education. part 1 considers how aca litigation arguments framed in traditional doctrinal terms missed much of the reality of health care. this suggests that the legal education may have failed to prepare advocates on both sides to identify and explain relevant arguments. thus, part 2 summarizes several relevant critiques of legal education. part 3 then considers aspects of health law that offer promising responses to some of these critiques. part 4 offers ideas for a broader vision for educating scholars and lawyers in health law. most important, the legal profession, like the medical profession, faces a system in which services are increasingly costly and concentrated among those with the greatest resources. the history of health reform itself may on academic health law, 41 wake forest l. rev. 391 (2006); mark a. hall, the history and future of health law.' an essentialist view, 41 wake forest l. rev. 347 (2006); rand e. rosenblatt, the four ages of health law, 14 health matrix 155 (2004); s. sandy sandbar et al., legal medicine and health law education, in legal medicine 3 (s. sandy sandbar et al. eds., 7th ed. 2007); walter wadlington, some reflections on teaching law and medicine in law school since the '60s, 14 health matrix 231 (2004); wendy k. mariner, toward an architecture ofhealth law, 35 am. j. l. & med. 67 (2009). 3 see u.s. const. art. i, § 8, cl. 1, 3 ("congress shall have power to lay and collect taxes . . . provide for the common defence and general welfare of the united states; . . . to regulate commerce with foreign nations, and among the several states, and with the indian tribes."). 2 vol. 10:1 did legal education fail health reform? hold lessons for the legal system and how to prepare lawyers to provide affordable services to all those in need. ii. the aca challenge was not an easy case when the aca was first challenged, some constitutional scholars believed it would be an easy case. 4 that assumption was belied by the fact that both aca opponents and supporters believed it was an easy case. nothing as path breaking as the aca, the most significant national legislation in the health care field since the 1965 enactment of medicare and medicaid, was likely to be easy. nonetheless, to many, the constitutional questions seemed straightforward when viewed from a traditional scholarly point of view. but, there were at least two points of view, based in large part on conceptions of federal power, and neither was adequate to argue or predict the outcome. neither side fully understood how "commerce" and "spending" functioned in the health care system, so their arguments remained largely abstract and detached from the facts. to varying degrees, the justices reflected a similar detachment in their opinions in the case. by now, the arguments are well known and will not be repeated here. suffice it to say that the arguments over the minimum coverage requirement parsed cases on congress's article i powers to tax and spend and to regulate commerce.5 the briefs, oral arguments, published articles, and the decision itself repeatedly analyzed supreme court decisions like wickard, lopez,7 raich,8 and comstock.9 4 see, e.g., david b. rivkin, jr. et al., a healthy debate: the constitutionality of an individual mandate, 158 u. pa. l. rev. pennumbra 93 (2009). 6 see, e.g., randy e. barnett, commandeering the people: why the health insurance mandate is unconstitutional, 5 n.y.u. j. l. & liberty 581 (2011); mark a. hall, commerce clause challenges to health reform, 159 u. pa. l. rev. 1825 (2011); jack m. balkin, commerce, 109 mich. l. rev. 1 (2010). 6 wickard v. filburn, 317 u.s. 111 (1942). 7 united states v. lopez, 514 u.s. 549 (1995). 8 gonzales v. raich, 545 u.s. 1 (2005). 2013 3 indiana health law review none of these cases offered an exact precedent for the minimum coverage requirement. congress had never imposed a precisely comparable requirement on individuals before.10 this alone made it a difficult case. of course, the fact that a law is novel does not make it unconstitutional. 1 during the great depression, the social security act was vigorously challenged as an unprecedented expansion of federal government authority to tax and spend a point that justice ginsburg tried to make in the aca oral argument.12 in 1937, the social security act challengers argued that congress's power to tax and spend for the general welfare did not include the power to pay oldage pensions only to the elderly. in helvering v. davis, the supreme court upheld the constitutionality of the social security tax on employees to provide pensions to the elderly,13 but the outcome was not a foregone conclusion. justices mcreynolds and butler dissented on the grounds that the act was "repugnant to the tenth amendment," 14 just as the aca challengers argued that the individual mandate invades state sovereignty. writing for the majority, justice cardozo apparently felt compelled to explain the national need for federal financial aid. he did so in language that could apply to health insurance today: 9 united states v. comstock, 130 s. ct. 1949 (2010). 10 see wendy k. mariner, leonard h. glantz & george j. annas, reframing federalism-the affordable care act (and broccol in the supreme court, 367 new engl. j. med. 12 (2012). 11 but see sebelius, 132 s.ct. at 2586 (opinion of roberts, c.j.) ("but sometimes 'the most telling indication of [a] severe constitutional problem ... is the lack of historical precedent' for congress's action."). 12 see transcript of oral argument at 57, dep't of health and human serv. v. fla., 132 s. ct. 2566 (2012) (no. 11-398), available at http://www.supremecourt.gov/oral-arguments/argument-transcripts/11398-tuesday.pdf. 13 see helvering v. davis, 301 u.s. 619 (1937) (upholding the social security act income tax on employees); see also steward mach. co. v. davis, 301 u.s. 548 (1937) (upholding social security act excise tax on employers). 14 helvering, 301 u.s. at 646 (reynolds, j. and butler, j., dissenting). vol. 10:14 did legal education fail health reform? needs that were narrow or parochial a century ago may be interwoven in our day with the wellbeing of the nation. what is critical or urgent change with the times. the purge of nation-wide calamity that began in 1929 has taught us many lessons. ... spreading from state to state, unemployment is an ill not particular but general, which may be checked, if congress so determines, by the resources of the nation.... but the ill is all one. . . whether men are thrown out of work because there is no longer work to do or because the disabilities of age make them incapable of doing it. rescue becomes necessary irrespective of the cause. the hope behind this statute is to save men and women from the rigors of the poor house ... .15 this kind of contextual explanation was largely missing from the aca litigation.1 6 without it, however, 15 id. at 641. 16 an exception was solicitor general donald verrilli's last minute plea at end of the last day of oral argument: there is an important connection, a profound connection between that problem and liberty. and i do think it's important that we not lose sight of that ... [because of the medicaid expansion] there will be millions of people with chronic conditions like diabetes and heart disease, and as a result of the health care they will get, they will be unshackled from the disabilities that those diseases put on them and have the opportunity to enjoy the blessings of liberty. and the same will be true for for a husband whose wife is diagnosed with breast cancer and who won't face the prospect of being forced into bankruptcy to try to get care for his wife and face the risk of having to raise his children alone, and i could multiply example after example after example. transcript of oral argument at 79-80, dep't of health and human serv. v. fla., 132 s. ct. 2566 (2012) (no. 11-400), available at http:// 2013 5 indiana health law review constitutional doctrine was not sufficient to resolve a matter of first impression either way.17 the court's majority and dissenting opinions found little precedent to support their conclusions, despite occasionally tortured efforts to identify analogies and distinctions in earlier cases. but this should not mean that novel cases can be decided on the basis of the justices' outcome preferences. where doctrine alone cannot control, it becomes necessary to understand what the law at issue actually does, so that doctrine can be refined in principled ways. the novelty of the aca meant applying doctrine which itself was less than crystal clear to complex issues of health care and health insurance financing. resolving the constitutional question depended on knowledge of the health care system, insurance, and how insurance is used to pay for health care. few, if any, constitutional scholars or practitioners had that knowledge.' 8 counsel for the challengers framed the commerce clause claim most simply: that a requirement to obtain health coverage was simply a mandate to buy a commercial www.supremecourt.gov/oral-arguments/argument-transcripts/1 1-400. pdf. 17 see wendy k. mariner, george j. annas & leonard h. glantz, can congress make you buy broccoli? and why that's a hard question, 364 new engl. j. med. 201 (2011); mark a. hall, commerce clause challenges to health reform, 159 u. pa. l. rev. 1825 (2011). 18 few people lawyers and judges included understand health insurance. and few of those who understand insurance in general understand health insurance, which functions quite differently from traditional indemnity insurance for things like cars and houses. see generally wendy k. mariner, health reform: what's insurance got to do with it? recognizing health insurance as a separate species of insurance, 36 am. j. l. & med. 436 (2010). some economists with expertise in the health care industry readily understood the rationale for requiring almost everyone to participate in an insurance pool, and many supported the minimum coverage requirement. see brief for economic scholars in support of petitioners urging reversal on the minimum coverage issue at 2-5, u.s. dep't of health & human serv. v. fla., 132 s. ct. 2566 (2012) (no. 11-398), available at http://www. americanbar.org/publications/previewhome/11-398.html; jonathan gruber, health care reform: what it is, why it's necessary, how it works (2011). but they were not in a position to present a doctrinal argument. 6 vol. 10:1 did legal education fail health reform? product, which amounted to requiring people to engage in commerce, not regulating any existing commerce.19 of course, the aca permits the coverage requirement to be satisfied by government-funded health benefit programs, such as medicare, medicaid, the department of veterans affairs, and the bureau of indian affairs, as well as employee group health plans.20 nevertheless, chief justice roberts and justices scalia, kennedy, thomas and alito accepted the characterization of health insurance as a commercial product.21 thus, if congress could require individuals to buy this commercial product, then surely it could require individuals to buy other products. 22 in light of 19 see brief for state respondents on the minimum coverage provision at 15, u.s. dep't of health & human serv. v. fla., 132 s. ct. 2566 (2012) (no. 11-398), available at http://www.americanbar.org/ publications/previewhome/11-398.html. 20 see 26 u.s.c. § 5000a(f) (2010); paul fronstin, sources of health insurance and characteristics of the uninsured: analysis of the march 2012 current population survey, emp't benefit research inst. issue brief no. 376, sept. 2012, at 4, available at http://www.ebri.com/publications/ib/index.cfm?fa=ibdisp&contentid=51 14 (noting that 18% of the nonelderly population was not covered by health insurance in 2011). 21 see generally sebelius, 132 s. ct. 2566. the chief justice and the justices in the joint dissent described health insurance only as a commercial product, and then only in terms of traditional non-group indemnity insurance, which is underwritten so that it is actuarially fair: you only pay for your own personal risks. however, all but a small proportion of health insurance in the united states is either public benefit programs or private employee group insurance, which is not underwritten. see fronstin, supra note 20, at 5 fig. 1; paul fronstin, employment-based health benefits: trends in access and coverage, 1997-2010, emp't benefit research inst. issue brief no. 370, apr. 2012, available at http://www.ebri.com/publications/ib/index.cfm?fa= ibdisp&contentid=5042. only about 7 percent of the nonelderly u.s. population is covered by underwritten, individual (non-group) health insurance policies. fronstin, supra note 20, at 5, fig. 1. 22 sebelius, 132 s. ct. at 2590 ("the mandate primarily affects healthy, often young adults who are less likely to need significant health care and have other priorities for spending their money."), at 2642 (scalia, j., kennedy, j., thomas, j., alito, j., dissenting). in fact, the major reason that people are uninsured is that they cannot afford the cost of insurance. summary health statistics for the u.s. population: national health interview survey, 2009, u.s. dep't of 2013 7 indiana health law review the breadth of commerce in today's national and global markets, such an expansive power looks more like the states' police power than a specific, enumerated federal power. these five justices expressly sought to preserve the distinction between federal and state sovereignty. 23 their solution was to draw a bright line between those who are and are not active or engaged in interstate commerce, with federal authority to regulate commerce limited to the former.24 although the justices did not constrict the scope of congress's commerce power, the majority would not expand it to include the power to require individuals to do something. 25 applying the active/inactive in commerce rule may not be as easy as the justices seemed to assume. as judge sutton noted in his concurring opinion upholding the individual mandate for the sixth circuit court of appeals below, many instances of doing nothing can be characterized as doing something else and vice versa.26 the absence of any analysis of how the boundaries may blur deprives the majority's commerce clause opinions of some measure of persuasiveness. 2 7 justice ginsburg, joined by justices breyer, sotomayor and kagan, dissented from the majority's commerce clause conclusions. her opinion demonstrated a better understanding of the health care system. it viewed health insurance not as a fungible commercial product, but as a necessary means of paying for health care. 28 since virtually health & human servs., 71 table 25 (2010), available at http://www.cdc.gov/nchs/data/series/sr_10/sr 10248.pdf. 23 sebelius, 132 s. ct. at 2575, 2642 (scalia, j., kennedy, j., thomas, j., alito, j., dissenting). 24 id. at 2591. 2 5 id. 26 thomas more law ctr. v. obama, 651 f.3d 529, 560-63 (6th cir. 2011) (sutton, j., concurring), cert. denied, (2012) (abrogated by sebelius, 132 s. ct. 2566). 27 sebelius, 132 s. ct at 2625 (ginsburg, j., concurring in part, concurring in the judgment in part, and dissenting in part) ("[i]f history is any guide, today's construction of the commerce clause will not endure."). 28 id. at 2610 (ginsburg, j.). 8 vol. 10: 1 did legal education fail health reform? everyone uses health care, they are already engaged in commerce, so the coverage requirement simply regulated how and when they pay for care. 29 this, she argued, would not open the door to federal requirements that individuals buy cars or vegetables, because other products do not share health insurance's characteristics. 30 this was a more complex argument to make, one requiring knowledge of the health care system. the majority and minority justices appeared to view the case through the lens of federalism. what was needed to convince a majority of the justices to uphold the aca's federal mandate under the commerce clause was a principled distinction between a requirement for health insurance coverage and a requirement to buy anything else one that also served to distinguish the commerce power from the police power. 31 such a distinction depended on facts specific to the health care system that would not apply to the purchase of all products. 32 in short, to win the commerce clause argument, the government needed a limiting principle, and neither the government nor any justice was able to articulate a sufficiently convincing one.3 3 29 id. at 2620 (ginsburg, j.) ("persons subject to the mandate must now pay for medical care in advance (instead of at the point of service) and through insurance (instead of out of pocket)."). 30 id. at 2624 (ginsburg, j.) ("one could call this concern the 'broccoli horrible,"' referring to the chief justice's mention of a mandate to buy green vegetables). 31 id. at 2591, 2642 (scalia, j., kennedy, j., thomas, j., alito, j., dissenting). 32 the brief of 104 health law professors as amici curiae in support of petitioners at page three, dep't of health & human serv. v. fla., 132 s. ct 2566 (2012) (no. 11-398), available at http://www .americanbar.org/content/dam/aba/publications/supreme-court preview/ briefs/11-398_petitioneramculo4healthlawprofs.authcheckdam.pdf (offering a factual description) was submitted to provide the court with those facts. together with mark a. hall, the author helped draft the brief, organized health law professors' participation, engaged counsel, and signed the brief. 33 sebelius, 132 s. ct. at 2642 (scalia, j., kennedy, j., thomas, j., alito, j., dissenting). paul clement, representing the state challengers, argued that the federal government had no limiting principle for congress's power to require individuals to buy commercial products, 2013 9 indiana health law review instead, both the parties and the justices argued the case in terms of abstract principles of federalism and barely looked beyond their own preferred interpretations of the commerce power. a better understanding of health insurance itself might have compelled the justices to think more deeply about what was being regulated. in the absence of cogent explanations, the court was left with an inadequate factual basis for determining whether the commerce power could apply to the minimum coverage requirement without implying that congress could force people to enter markets involuntarily. 34 thus, the justices' opinions tracked their and began his oral argument by stating that the individual mandate is "an unprecedented effort by congress to compel individuals to enter commerce." transcript of oral argument at 55, dep't of health and human serv. v. fla., 132 s. ct. 2566 (2012) (no. 11-398). see mariner, supra note 17, at 201-201 (noting the need for a persuasive limiting principle). this is not the first time that constitutional law scholars have misjudged the supreme court in health law cases. professor laurence tribe argued on behalf of patients for the right to have physicians assist their suicides. vacco v. quill, 521 u.s. 793 (1997). at the time, colleagues suggested that it should be an easy win: the supreme court would find a constitutional right to physician-assisted suicide and strike down laws prohibiting physician assisted suicide, perhaps relying on justice kennedy's "mystery of human life" language in planned parenthood of southeastern pa. v. casey, 505 u.s. 833, 851 (1992). but, the court did not do so. its decision made clear that the court wanted a limiting principle on the purported right to assisted suicide, which the litigants did not provide. wash. v. glucksberg, 521 u.s. 702, 733 (1997). 34 the majority's decision on the medicaid eligibility expansion also demonstrated incomplete knowledge of the structure and history of medicaid, but the decisive factor appeared to be preserving state jurisdiction over the state's laws implementing medicaid programs. sebelius, 132 s. ct. at 2601-8. the chief justice's opinion relied for the first time on the concept of coercion to find that the spending power precluded the federal government from ending all federal medicaid funding of states that declined to adopt the newest category of eligible beneficiaries (adults under 65 years of age with incomes less than 133% of the federal poverty level) added by the aca. id. at 2606-7; 42 u.s.c. §§ 1396(a)(10)(a)(i)(viii), 1396c (2012). vol. 10:110 did legal education fail health reform? views of the boundary between federal and state jurisdiction. 35 the idea that the parties failed to appreciate relevant facts about the structure and financing of the health care system is significant, but not because a factual analysis should displace doctrinal analysis. rather, doctrine requires interpretation when it is applied to new subject matter, and meaningful application of doctrine requires an accurate understanding of the subject matter. if the subject matter is misunderstood, the doctrine may be interpreted in incongruous ways, which may distort doctrine in its applications in other contexts.36 regardless of whether such an analysis would have upheld the individual mandate, it should have produced a more robust and persuasive refinement of the definition of commerce. iii. does legal education contribute to ineffectual scholarship or practice? two conclusions can be drawn from the public and courtroom debate over the constitutionality of the individual 35 this is not to say that the justices are motivated by public opinion or politics, which are not the same as ideology. see lawrence baum & neal devins, why the supreme court cares about elites, not the american people, 98 geo. l. j. 1515 (2010) (arguing that the justices probably care more about the opinions of elites than the public). 36 for example, in his opinion on the medicaid expansion, the chief justice called the addition of the new eligibility category "a shift in kind, not merely degree." sebelius, 132 s. ct. at 1575. yet, the opinion does not identify any relevant factual distinction between the eligibility categories originally in effect and added by pre-2010 amendments and the category added by the aca. see generally sara rosenbaum & timothy stoltzfus jost, all heat, no light the states' medicaid claims before the supreme court, 366 new eng. j. med. 487 (2012). without a clear distinction, the decision invites confusion and future litigation over whether statutory amendments qualify as amendments or create entirely new programs. the joint dissent's characterization of generous federal funding as "coercive" is similarly unclear. sebelius, 132 s. ct. at 2643 (scalia, j., kennedy, j., thomas, j., and alito, j., dissenting). see coll. say. bank v. fla. prepaid postsecondary ed. expense bd., 527 u.s. 666 (1999); s.d. v. dole, 483 u.s. 203 (1987). 2013 11 indiana health law review mandate: (1) health law issues pervade modern society; and (2) well trained lawyers failed to adequately explain or justify their positions on the constitutionality of the aca. both conclusions suggest that legal education may be missing an opportunity to prepare both scholars and practicing lawyers for effective careers today. several critiques of legal education offer clues to what might contribute to this missed opportunity. the critiques of interest here are a highly selective sample. 37 i will not address the challenges that universities themselves face, which include increasing competition for students in a difficult economic environment with rising costs, income inequality, and high student loan debt, 38 37 for comprehensive overviews, see brian z. tamanaha, failing law schools (2012); lauren carasik, renaissance or retrenchment: legal education at a crossroads, 44 ind. l. rev. 735 (2011). well known studies of legal education include william m. sullivan, anne colby, judith welch wegner, lloyd bond & lee s. shulman, educating lawyers: preparation for the profession of law (the carnegie found. for the advancement of teaching ed. 2007) [hereinafter carnegie report]; am. bar ass'n, section on legal education and admissions to the bar & task force on law schools and the profession: narrowing the gap, legal education and professional development an education continuum (1992) [hereinafter maccrate report]; am. bar ass'n, section on legal education and admissions to the bar, report and recommendations of the task force on lawyer competency: the role of law schools (1979) [hereinafter crampton report]. 38 see u.s. gov't accountability off., report to congressional committees higher education: issues related to law school cost and access (2009), available at http://www.gao.gov/new.items/dl020.pdf. the project on student debt at the institute for college access & success estimated that "two-thirds of college seniors who graduated in 2010 had student loan debt, with an average of $25,250." student debt and the class of 2010, the institute for college access & success (nov. 3, 2011), http://ticas.org/files/pub/classof2olo.pdf. see the student loan 'debt bomb". america's next mortgage-style economic crisis?.a report prepared for the national association of consumer bankruptcy attorneys (na cba), nacba (feb. 7, 2012), http://nacba.org/portals//documents/student%2loan%2odebt/020712 %20nacba%20student%201oan%20debt%20report.pdf (reporting that "americans now owe more on student loans than on credit cards."). the 12 vol. 10:1 did legal education fail health reform? technological advances, and pressure to disclose graduate employment data,39 reduce tuition, augment endowments, and demonstrate the value-added of a university education.40 most law schools sit within universities, and their fate is tied to a significant degree with the fate of their university.41 but law schools face their own unique challenges. perhaps the most pressure to conform to a traditional model of legal education comes from the rankings, whose criteria drive law schools' activities and metrics. 4 2 but these are so well known, and almost total amount of outstanding student loans exceeded $1 trillion in 2011. id. at 1. 3 the american bar association section of legal education and admissions to the bar, the accrediting body for u.s. law schools, adopted a requirement in june 2012, approved by the aba house of delegates in august 2012, that law schools disclose data on graduates' employment, student attrition, and scholarships conditioned on minimum grades. debra cassens weiss, no fudging: revised standard bars law schools from publishing misleading consumer info, aba journal (aug. 2, 2012), http://www.abajournal.com/news/article/no fudging-revised standard b arslawschoolsfrom-publishing-misleadin (last visited nov. 8, 2012). 40 in an address at the university of michigan in january 2012, president obama said: "so, from now on, i'm telling congress we should steer federal campus-based aid to those colleges that keep tuition affordable, provide good value, serve their students well. we are putting colleges on notice. . . . if you can't stop tuition from going up, then the funding you get from taxpayers each year will go down." obama in ann arbor: text of the president's speech on affordability, annarbor.com (jan. 27, 2012), http://www.annarbor.com/newslobama-in-ann-arbor-text-of-thepresidents-speech-on-college-affordability/ (last visited nov. 8, 2012). 41 gene r. nichol, rankings, economic challenge, and the future oflegal education, 61 j. legal educ. 345 (2012). 42 see tamanaha, supra note 37, at 78-99; michael sauder & wendy espeland, fear of falling: the effect of us. news & world report rankings on us. law schools grant report 07-02, in l. sch. admissions council report series 9-15 (2007), available at http://www.1sac.org/1sacresources/research/gr/gr-07-02.asp; deborah l. rhode, legal education: professional interests and public values, 34 ind. l. rev. 23, 25 (2000). 2013 13 indiana health law review universally lamented, that there is no need to mention them further.43 the best-known criticisms of legal education are what i call the ivory tower critiques. these argue that legal education (1) is overly abstract and distant from real world problems, with too much emphasis on theory, (2) offers limited attention to practice issues, in particular, what lawyers do interacting with clients, prosecutors, businesses, administrative agencies, and other lawyers, and (3) produces scholarship of limited relevance to practitioners or judges.44 legal education has been criticized for its distance from practice for decades, notably by karl llewellyn and jerome frank.45 a notorious example of the ivory tower critique is justice roberts' comment at a 4th circuit judicial conference in white sulphur springs, west virginia, in june 2011. he reportedly said: 43 this essay also does not address styles of teaching or student learning, student stress, exams and methods of assessment, law school accreditation, or false advertising about law jobs after graduation, which has been much in the news recently. see, e.g., rogelio a. lasso, is our students learning? using assessments to measure and improve law school learning and performance, 15 barry l. rev. 73 (2010); g. andrew h. benjamin et al., the role of legal education in producing psychological distress among law students and lawyers, 11 am. b. found. res. j. 225 (1986); ann l. lijima, lessons learned: legal education and law student dysfunction, 48 j. legal educ. 524 (1998); david segal, for law schools, a price to play the a.b.a.'s way, n.y. times (dec. 17, 2011), http://www.nytimes.com/2011/12/18/ business/for-law-schools-a-price-to-play-the-abas-way.html?pagewanted =all& r=0. 44 see, e.g., harry t. edwards, the growing disjunction between legal education and the legal profession, 91 mich. l. rev. 34 (1992); stewart macauly, law schools and the world outside their doors ii: some notes on two recent studies of the chicago bar, 32 j. legal educ. 506 (1982); carnegie report, supra note 37, at 95-97; maccrate report, supra note 37; crampton report, supra note 37, at 3-4, 15-18. 45 see generally karl n. llewellyn, the bramble bush: some lectures on law and its study (1930); jerome frank, w7hy nota clinical lawyer school?, 81 u. pa. l. rev. 907 (1933). 14 vol. 10:1 did legal education fail health reform? pick up a copy of any law review that you see, and the first article is likely to be, you know, the influence of immanuel kant on evidentiary approaches in 18th century bulgaria, or something, which i'm sure was of great interest to the academic that wrote it, but isn't of much help to the bar.4 6 perhaps this is why judges rarely read law review articles. few law school professors would dispute the claim that their legal research, at least before tenure review, focuses on developing novel theories of law, which are read almost exclusively by other law professors. 47 the grain of truth in the ivory tower critique one that is relevant to the aca litigation is that the focus on theory may blind lawyers to the need for more specific and intensive examination of the subject matter to which theory and doctrine may apply. however, this does not mean that law schools ought to abandon rigorous teaching about theory and doctrine. 48 such teaching is foundational necessary, but not sufficient. rather, the critique raises the perennial question of whether law schools should be training practitioners, as in the historical trade school model, or educating research scholars, as in the traditional ph.d model.49 46 law prof ifill challenges chief justice roberts' take on academic scholarship, am. constitution soc'y blog (july 5, 2011), http://www.acslaw.org/acsblog/law-prof-ifill-challenges-chief-justiceroberts%e2%80%99-take-on-academic-scholarship (last visited nov. 8, 2012). 47 see erwin chemerinsky, why write?, 107 mich. l. rev. 881, 885 (2009). 48 see, e.g., richard a. posner, the deprofessionalization of legal training and scholarship, 91 mich. l. rev. 1921 (1993); george l. priest, the growth of interdisciplinary research and the industrial structure of the production of legal ideas:' a reply to judge edwards, 91 mich. l. rev. 1929 (1993); lee c. bollinger, the mind in the major american law school, 91 mich. l. rev. 2167 (1993). 49 see william r. trail & william d. underwood, the decline of professional legal training and a proposal for its revitalization in professional law schools, 48 baylor l. rev. 201 (1996). 2013 15 indiana health law review law schools and lawyers have struggled with the question of which model suits legal education since the civil war era.50 nineteenth century german and other european university systems, which had established faculties in theology, philosophy, medicine, and law, apparently impressed several influential academics. 51 the european conception of law as a science that required formal study distinguished the legal profession from a mere guild for craftsmen.52 it helped to characterize law as an academic discipline, instead of a trade, and worthy of placement within a university at a time when universities were becoming research institutions. it also offered an opportunity to develop an elite class of law professors capable of teaching the science full-time academics who gradually replaced practicing lawyers as teachers.53 these attractions elevated research and scholarship over occupational training as the benchmark for academic standing. the development of formal legal education supplanted apprenticeship with practicing lawyers and culminated in today's model of a three-year program of graduate studies following a university undergraduate degree.54 50 robert stevens, law school: legal education in america from the 1850's to the 1980's 24, 51, 135, 265 (1983). see generally james willard hurst, the growth of american law: the law makers (1950). 51 see gail j. hupper, the rise of an academic doctorate in law-' origins through world war ii 49 am. j. legal hist. 1, 8-9 (2007) (noting the presidents of harvard, cornell and chicago as examples). for an example of this influence, see oliver wendell holmes, the use and meaning of law schools, and their methods of instruction, 20 am. l. rev. 919 (1886). 52 stevens, supra note 50, at 52-53; james e. herget, the influence of german thought on american jurisprudence, 1880-1918, in the reception of continental ideas in the common law world 1820-1920 203, 215 (mathias reimann ed., 1993). 53 mathias reimann, a career in itself-the german professoriate as a model for american legal academia, in the reception of continental ideas in the common law world 1820-1920 165, 188 (mathias reimann ed., 1993). 54 stevens, supra note 50, at 205, 209. vol. 10: 116 did legal education fail health reform? law professors have been expected to write scholarly articles, perhaps since then dean of harvard law school urged it as one of three essential elements of the faculty in 1901.55 yet, the quality of law faculty scholarship is highly variable. despite chief justice roberts' critique, there are thoughtful, relevant and useful law review articles (many of them in health law).56 however, the more practical and relevant they are, the less likely they are to provide support for tenure. if we are honest, we must concede that the pressure to be original in theory or, to a lesser extent, doctrine can produce irrelevant sometimes ridiculous scholarship that would never be accepted in any other field of research.57 furthermore, there is almost no supervision 55 james barr ames, the vocation of the law professor, in lectures on legal history and miscellaneous legal essays 364 (1913) (noting that the other elements are teaching, id. at 362, and influencing legislation and the development of the law, id. at 367). 56 see, e.g., frank pasquale, new york times financial advice: be an unpaid intern through your 20s (the work till you're 100), balkinization (nov. 20, 2011), http://balkin.blogspot.com/2011/11/newyork-times-financial-advice-be.html (noting nicolas terry's "cutting edge work on digital medical records"); nicolas p. terry, what's wrong with health privacy? 5 j. health & biomed. l. 1 (2009); sidney d. watson, the road from massachusetts to missouri: can other states replicate massachusetts'health reform, 55 kan. l. rev. 1331 (2007). 57 see, e.g., colin camerer et al., regulation for conservatives: behavioral economics and the case for 'asymmetric paternalism" 151 u. pa. l. rev. 1211 (2003) ("the fact that suicide is currently illegal marks a classic form of heavy-handed paternalism ... . an alternative policy .. . is to sanction suicide, but only after a mandatory cooling-off period. such a policy might, for example, require a suicidal person to 'give notice' of the desire to commit suicide one month in advance with the ability to rescind the notice at any point during the intervening period."). the authors were apparently not aware that suicide was (and is) not illegal, so their factual premise was in error. instead, they made an interesting theoretical argument for replacing the non-existent crime with an impractical alternative, since a majority of suicide attempts are spur of the moment decisions, which are not likely to be affected by any notice requirement. institute of medicine, reducing suicide: a national imperative (s.k. goldsmith et al. eds., 2002); keith hawton, christopher ware, hamant mistry, et al., why patients choose paracetamol for selfpoisoning and their knowledge of its 2013 17 indiana health law review of the accuracy of legal research.58 student journal editors are well trained in paragraph structure and reference formatting, but are rarely familiar with the subject matter of the article they "edit." few law journals use peer review to vet articles submitted for publication, so external experts have no opportunity to evaluate the premises, methods or conclusions of papers before publication. moreover, few experts who are able to notice errors even read the journals. law students typically rely on law review articles for their own research, so that errors embedded in journals are often perpetuated rather than corrected over time. law schools do some things well. the very first observation of the carnegie report was: within months of their arrival in law school, students demonstrate new capacities for understanding legal processes, for seeing both sides of legal arguments, for sifting through facts and precedents in search of the more plausible account, for using precise language, and for understanding the applications and conflicts of legal rules. despite a wide variety of social backgrounds and undergraduate experiences, they are learning, in the parlance of legal education, to 'think like a lawyer.'59 learning how to think like a lawyer is especially valuable for issue-spotting, but it has a downside. one dangers, 310 brit. med. j. 164.1 (1995), available at http://www .bmj.com/content/310/6973/164. 1. 58 there is some irony in the fact that legal scholarship was intended to resemble that of research for ph.d.s in university departments, partly to justify legal studies as graduate level academic work, but did not adopt the same oversight and peer review requirements. see stevens, supra note 50. 59 william m. sullivan, anne colby, judith welch wegner, lloyd bond & lee s. shulman, educating lawyers: preparation for the profession of law, summary 5 (the carnegie found. for the advancement of teaching ed. 2007) [hereinafter carnegie summary]. critiques of the carnegie report soon proliferated. see, e.g., kristen holmquist, challenging carnegie, 61 j. legal educ. 353 (2012). vol. 10:118 did legal education fail health reform? disadvantage arises from the use of casebooks, which publish highly edited versions of reported appellate cases stripped of factual details to demonstrate legal principles. the carnegie report observes that: most law schools emphasize the priority of analytic thinking, in which students learn to categorize and discuss persons and events in highly generalized terms. this emphasis on analysis and system has profound effects in shaping a legal frame of mind. at a deep, largely uncritical level, the students come to understand the law as a formal and rational system, however much its doctrines and rules may diverge from the common sense understandings of the lay person.60 the idea that law is a science a set of (ideally neutral) principles that can be discerned with the appropriate analytic and conceptual skills remains embedded in the core justification for legal education.6 us law schools narrowed the scope of the original european idea of law as science. nineteenth century european curricula included history, economics, political theory, sociology, roman law, and comparative law as part of the study of law. us law schools dropped those subjects for decades and only slowly reintroduced them in somewhat different forms, typically under specialized rubrics like law and economics and law and society.62 to be sure, critiques from successive movements legal realism, positivism, critical legal theory, feminist theory, and social theory have substantially 60 carnegie summary, supra note 59, at 5. 61 see generally stevens, supra note 50; herget, supra note 52. 62 stevens, supra note 50, at 277. see, e.g., richard a. posner, economic analysis of law (8th ed. 2010); sabine frerichs, studying law, economy and society a short history of socio-legal thinking, (u. helsinki research paper series, legal studies research paper series no. 19, 2012), available at http://ssrn.com/abstract=2022891; morton horwitz, transformation of american law (1977); roberto unger, law in modern society (1976). 2013 19 indiana health law review weakened law's claim to universality and neutrality.63 but the core claim is hard to give up. if law is simply the result of power struggles, what science remains for law schools to teach? our students might be better off in departments of political science, economics, or sociology. 64 the solution cannot be to ignore theory or return to the days of apprenticeship training. however, insistence on developing novel and arcane theories divorced from the factors that influence law is driving scholarship farther away from making a meaningful contribution to jurisprudence. 65 the future of law schools may depend on a revolutionary rethinking of their structure and curriculum. of course, law schools have not ignored these challenges. nonetheless, a multitude of obstacles has stymied meaningful change. most valuable reforms implemented so far, such as clinical seminars and externships, tend to be additions to a crowded curriculum.6 6 moreover, they are often taught by clinical faculty, who complain of second class citizenship, often quite rightly.67 the real problem is that patching in new courses does little to change the perspective of legal education. 63 see, e.g., duncan kennedy, legal education and the reproduction of hierarchy: a polemic against the system (2004); laura kalman, legal realism at yale, 1927-1960 (1986); robert w. gordon, historicism in legal scholarship, 90 yale l. j. 1017 (1981); john henry schlegel, american legal realism and empirical social science: from the yale experience, 28 buffalo l. rev. 459 (1979). 64 see generally david van zandt et al., the case against law school, n.y. times (july 21, 2011), http://www.nytimes.com/roomfor debate/2011/07/21/the-case-against-law-school?hp (discussing the need for law schools and their structure). 65 see gary l. blasi, what lawyers know: lawyering expertise, cognitive science, and the functions of theory, 45 j. legal educ. 313 (1995). 66 see margaret martin barry, jon c. dubin & peter a. joy, clinical education for this millennium: the third wave, 7 clinical l. rev. 1 (2000). 67 see elliott s. milstein, clinical legal education in the united states: in-house clinics, externshps, and simulations, 51 j. legal educ. 375 (2001) (describing the range of programs). 20 vol. 10:1 did legal education fail health reform? this brings me to a different set of criticisms of legal education, which i call the social justice critique. this critique argues that many programmatic elements of the curriculum narrow the scope of legal analysis to one that preserves the status quo, perpetuates powerful elites68 and stifles creative thinking about the law and solutions to legal problems. of particular concern is the categorization of required and elective courses. to social critics, the foundational courses of contracts, torts, civil procedure, and property immediately establish an image of law as primarily private case law. this private law emphasis reinforces the idea that corporate and property issues are the core of law, because they are the focus of learning how to think like lawyers. directly or indirectly, it can train students to accept the existing structure of public and private institutions and financial relationships as normative and neutral in their effects, and thus to perpetuate the status quo.69 courses in legislation, administrative law, employment law, anti-discrimination law, and the like are typically relegated to elective status, creating the impression such subjects are peripheral in value. this can create a distorted picture of the legal landscape, especially since so much legal practice involves the drafting, interpretation, and application of legislation and regulations. while the case method has substantial value in learning to think like a lawyer, the use of edited casebooks 68 joan williams notes that "one role of law school has been to train members of the elite to assume elite positions," and "langdell invented his curriculum at harvard to boss around other members of the elite," but adds that it now also serves as a pathway for non-elites to enter the elite class. bob gordon, jack schlegel, james may & joan williams, colloquium: legal education then and now: changing patterns in legal training and in the relationship of law schools to the world around them, 46 am. u. l. rev. 747, 769 (1998). 69 the expense of a legal education and the concentration of employment in corporate-oriented practice may exacerbate this effect, making access to justice unaffordable for low and middle-income americans. see gene r. nichol, jr., judicial abdication and equal access to the civil justice system, 60 case w. res. l. rev. 325 (2010); rhode, supra note 42, at 23. 2013 21 indiana health law review sometimes undermines creative thinking.70 some casebooks drain the life out of legal problems. few contain facts to illuminate the context of legal problems. the discussion of cases leads students to focus on the legal issue, separate and apart from the social context. problems are abstracted from their human dimension and considered only with respect to whether they fall within a rule.71 the supreme court's oral arguments exemplified a similar "bloodless" debate. it teaches that the ethical and social consequences of justifiable principles are beyond the scope of relevant consideration. the absence of context how and why legal problems arise in a particular society gives students little opportunity for thinking about how to make strategic choices. 72 without practice at attention to context, law graduates may not recognize the complexity of their clients' problems. 73 in light of the dynamic nature of many legal rules, and especially regulations, there is significant need for thinking carefully not only about what legal remedies are available, but also why only these and not others exist, and whether others could be developed. in this way, context can nurture useful new theories in law. the carnegie report also notes that law schools pay less attention to the civic, professional, ethical and leadership roles of lawyers.74 thus, graduates may miss important opportunities to exercise leadership to improve social 70 see generally todd d. rakoff & martha l. minow, a case for another case method, 60 vand. l. rev. 597 (2007) (critiquing the case method); susan sturm & lani guinier, the law school matrix: reforming legal education in a culture of competition and conformity, 60 vand. l. rev. 515 (2007) (critiquing the case method); laura kalman, to hell with langdell, 20 law & soc. inquiry 771 (1995) (critiquing the case method). 71 see, e.g., carnegie report, supra note 37, at 187. 72 see generally steven l. winter, a clearing in the forest: law, life, and mind (2001). 73 see kristen holmquist, challenging carnegie, 61 j. legal educ. 353 (2012). 74 see carnegie report, supra note 37, at 6. see also angela p. harris & marjorie shultz, "a(nother) critique of pure reason": toward civic virtue in legal education, 45 stan. l. rev. 1773 (1993). vol. 10:122 did legal education fail health reform? institutions.75 furthermore, a tight focus on legal doctrine can breed hammer-and-nail problems: when your only tool is a hammer, every problem looks like a nail. if law is your tool, you may tend to view law as the sole cause of and therefore the only solution to a problem.76 sometimes, law is not the answer. lawyers who fail to recognize complex sources of problems causes can miss the most effective solutions. iv. health law offers a model for rethinking legal education, at least in part the health law field suffers less from these criticisms than do most other legal fields and has several advantages that could be translated to other areas in the law curriculum. a particular advantage of health law in responding to critiques of legal education is that, as an applied area, it cannot avoid attention to real world problems. moreover, these problems range across social and economic life from birth to death, exposing students to a wide array of both doctrinal and practical issues.7 7 after 75 see karen h. rothenberg, recalibrating the moral compass expanding 'thinking like a lawyer" into 'thinking like a leader" 40 u. tol. l. rev. 411 (2009). 76 for example, liability for injury is often cited as a major cause of problems like the high cost of some pharmaceuticals, the limited development of new vaccines, the price of medical malpractice premiums, and insufficient volunteers in emergencies, without examining other reasons, such as low return on investment, lack of market demand or resources, or better alternatives. see generally aaron s. kesselheim & kevin outterson, improving antibiotic markets for long term sustainability, 11 yale j. health pol'y l. & ethics 101 (2011); charles h. schultz & george j. annas, altering the standard of care unnecessary and dangerous, 59 annals emergency med. 191 (2011); marc a. rodwin, hak j. chang & jeffrey clausen, malpractice premiums and physicians'income: perceptions of a crisis conflict with empirical evidence, 25 health aff. 759 (2006); william m. sage, medical malpractice insurance and the emperor's clothes, 54 depaul l. rev. 463 (2005); 77 see clark c. havighurst, health care as a laboratory for the study of law and policy, 38 j. legal ed. 499, 499 (1988) (noting that 2013 23 indiana health law review all, in 2010, national health expenditures were $2.6 trillion dollars or 17.9% of gdp. 78 thus, health law teaching and scholarship is firmly connected to the real world. even theoretical scholarship in the health law field demands connection to facts.79 health law issues also invite indeed demand attention to the larger context in which legal problems arise, because the consequences of interpreting some laws in one way rather than another can be significant when health is at stake.80 at the same time, the process of applying different laws can inspire new theories and valuable critiques of doctrine in light of their implications for solving legal problems.8' ethical issues are especially salient, and not just in abortion, euthanasia, and treatment refusal. 82 for instance, laws governing medical marijuana should take into account how effective medical treatments for different diseases are. evaluating conflicts of interest among researchers requires familiarity with the way in other fields "lack the magnitude, complexity and universality of health care"). 78 anne b. martin et al., growth in us health spending remained slow in 2010; health share of gross domestic product was unchanged from 2009, 31 health aff. 208, 208-9 & exhibit. 1 (2012). 7 to be sure, as in all fields, health law scholarship includes theory divorced from facts, but that is a different question of the quality and accuracy of scholarship, not its subject matter. see infra notes 9599 and accompanying text. 80 george j. annas, standard of care: the law of american bioethics 246-249 (1993). 81 see, e.g., wendy e. parmet, populations, public health, and the law (2009) (infusing constitutional doctrine with public health values); nan d. hunter, risk governance and deliberative democracy in health care, 97 geo. l. j. 1 (2008); mark a. hall, trust, law, & medicine, 55 stan. l. rev. 955 (2003). 82 many biomedical ethics texts present issues that also raise legal questions. see, e.g., ethical issues in modern medicine (bonnie steinbock, john arras & alex john london, eds., 7th ed. 2008); george j. annas, american bioethics xv (2005) (reiterating that "american law, not philosophy or medicine, is primarily responsible for the agenda, development and current state of american bioethics"). some casebooks now combine both ethical and legal issues. see, e.g., health care law and ethics, (mark a. hall, maryann bobinski & david orentlicher, eds., 2007). vol. 10:124 did legal education fail health reform? which biomedical research is conducted. larger questions of distributive justice can arise when interpreting or critiquing statutes that regulate financing and access to care. a recent example is the controversy over health insurance coverage of contraceptives, now required under the aca.83 the study of health law can encourage critical thinking about whether a particular legal approach should be used instead of another, in light of their respective civic and ethical implications. 84 in short, as annas has noted, studying medical problems provokes thinking about what it means to be human and "therefore what rights and obligations humans should have."85 legal issues arise in clinical care, public health programs, biomedical research, corporate structures, product standards, conditions of employment, health insurance coverage and financing, responsibilities for children, and professional licensure, as well as the physician-patient relationship. health law specialists must identify all laws that may affect a problem. therefore, health law applies law from many legal domains: administrative law,8 6 antitrust, antidiscrimination, 83 fact sheet* women's preventive services and religious institutions, office of the press sec'y (feb. 10, 2012), http://www.whitehouse.gov/the-press-office/2012/02/10/factsheetwomen-s-preventive-services-and-religious-institutions; robert pear, us. clarifies policy of birth control for religious groups, n.y. times (mar. 16, 2012), http://www.nytimes.com/2012/03/17/health/policy/ obama-administration-says-birth-control-mandate-applies-to-religiousgroups-that-insure-themselves.html; catholic business owners win temporary halt in birth control mandate, reuters (july 27, 2012), http://newsandinsight.thomsonreuters.com/legal/news/2012/07_july/catholic business owners wintemporary halttoobama birth control-mandate/. 84 see, e.g., wendy k. mariner, the affordable care act and health promotion: the role of insurance in defining responsibility for health risks and costs, 50 duquesne l. rev. 271 (2012); nicole huberfeld, federalizing medicaid, 14 u. pa. j. const. l. 431 (2011). 85 annas, supra note 80, at 248. 86 a remarkable number of administrative agencies deal with health issues, including the centers for medicare and medicaid, the food and agriculture drug administration, the environmental 2013 25 indiana health law review constitutional law, contracts, corporations, criminal law, employment law, environmental law, insurance, international law, patents, privacy, and torts. so many different legal issues are connected to health that one might devote one or more semesters to them without sacrificing attention to important doctrinal learning, not only because the field is so broad, but also because doctrine taught in other courses can be learned within health law courses. 8 7 applied fields have many opportunities to use problemoriented methods, which require students to identify the different legal tools that could be brought to bear on a real problem. this approach is closer to law practice than the study of domains of law or legal doctrine in the abstract. 88 many health law professors have embraced practical lawyering skills somewhat more enthusiastically than most other specialties, offering students opportunities to work with law firms, hospitals, and legislatures, and to draft briefs amici curiae for relevant litigation.89 northeastern university school of law is a leading example of experiential (practice-based) legal education; its cooperative program places law students in supervised protection agency, the occupational safety and health administration, as well as state departments of health and environmental protection. 87 annas, supra note 80, at 258. 8 see, e.g., jonathan todres, beyond the case method. teaching transactional law skills in the classroom, 37 j. l. med. & ethics 375 (2009). 89 this is not to suggest that health law teaching is always successful. the american health lawyers association surveyed 94 health law practitioners in 2011 on their evaluations of new health law graduates. preliminary results suggest that those surveyed reported that the new associates were best at legal research, analytical and reasoning skills, and advocacy and persuasion. they were less well prepared in writing skills, strategic thinking, problem solving, administrative law and the regulatory process. kevin outterson, associate professor of law at boston university, presentation at the american health law association annual meeting (june 25, 2012) (copy on file with author). 26 vol. 10:1 did legal education fail health reform? practice settings, especially in public interest, international and human rights law.90 scholarship in health law is often relevant to policymakers. health law issues appear in the news almost daily, as well as in legislatures and courtrooms around the country. keeping abreast of the field necessarily requires paying attention to real world developments, and this includes problems of economics, politics, and moral reasoning. one way to influence the development of the law is to reach policy-makers, and health law scholars often publish in medical and policy journals, such as health affairs and the new england journal of medicine, which policy-makers are likely to read.91 empirical research is also growing in health law, perhaps because of its emphasis on effective solutions to real problems. 92 opportunities for 90 about northeastern university law school, northeastern univ., http://www.northeastern.edullaw/about/index.html (last visited nov. 1, 2012); stevens, supra note 50, at 233, 241. 91 see, e.g., timothy s. jost, employers and the exchanges under the small business health options program: examining the potential and the pitfalls, 31(2) health aff. 267 (feb. 2012); mark a. hall, wenke hwang & allison snow jones, model safety-net programs could care for the uninsured at one-half the cost of medicaid or private insurance, 20 health aff. 1698 (sept. 2011); david a. hyman & william m. sage, do health reform and malpractice reform fit together? american enterprise institute for public policy research working paper 2011-02 (2011), available at http://www.aei.org/files/ 2011/04/01/2011-04-hyman-sage.pdf. 92 see martin partington, empirical legal research and policymaking, in the oxford handbook of empirical legal research 1002 (peter cane & herbert m. kritzer, eds. 2010) (arguing that empirical legal research should be valuable to policy makers, because it can provide evidence to identify gaps and weaknesses in current law, strategies for change, and areas where legislation is not likely to solves problems, id at 2003-4). for examples of empirical research in health law, see nicolas p. terry, meaningful adoption: what we know and think we know about the financing, effectiveness, quality and safety of electronic medical records, j. legal medicine (forthcoming 2012); ann hwang, sara rosenbaum & benjamin d. sommers, creation of state basic health programs would lead to 4 percent fewer people churning between medicaid and exchanges, 31(6) health aff. 1314 (june 2012); bernard black, charles silver, david a. hyman & william 2013 27 indiana health law review employment in health law grow almost as fast as the health system, and this growth should accelerate as the aca is implemented. new ideas and new courses have entered the curriculum most often when there was a need for new legal skills. for example, in the 1800's, harvard law school prepared its graduates to become legislators and social leaders by teaching the federalist and also political science. 93 after the new deal created new administrative agencies, law schools began teaching administrative law and policy to prepare graduates to lead those agencies. 94 when the administrations of presidents reagan, george h.w. bush, and george w. bush favored more libertarian approaches to governing, they began to appoint lawyers trained in law and economics as well as federalist society members to federal administrative positions and judgeships. 95 today, there should be expanded opportunities for employment for lawyers who know the health care system, as well as those in environmental law. these opportunities exist not only in private law practice, but also in government agencies, legislatures, and commercial and nonprofit health-related organizations. health law training can prepare lawyers for all these options, because it includes systematic knowledge of health systems. of course, the health law field is not without its own problems. the most daunting is its scope. 96 it is difficult to master all the relevant legal domains and avoid sage, stability, not crisis: medical malpractice claim outcomes in texas, 1988-2002, 2 j. empirical legal stud. 207 (2005). 93 r. kent newmyer, harvard law school, new england legal culture, and the antebellum origins of american jurisprudence, in the constitution and american life 154-175 (david thelen ed., 1988). 94 charles epp, the rights revolution: lawyers, activists and supreme courts in comparative perspective 197 (1998). 9 steven m. teles, the rise of the conservative legal movement: the battle for control of the law 141, 158 (2008). 96 wendy k. mariner, toward an architecture of health law, 35 am. j. l. & med. 67, 68 (2009). 28 vol. 10:1 did legal education fail health reform? dilettantism. 97 as a result, the quality of health law scholarship remains uneven. some of the health law field's advantages may undermine rigor in scholarship. for example, empirical and other research that is funded by external donors may be influenced, perhaps unwittingly, by the money itself or the donor's goals, in the same ways that conflicts of interest can affect biomedical research.98 if funding is available for drafting new laws limiting liability, for example, but not for laws reducing the risk of harm, then more recommendations for liability limits are likely to be produced. health law often considers valuable insights from other disciplines, which should expand and enhance our view of the law and its effects. at times, however, viewing a legal issue only from a single disciplinary perspective can distort the analysis. learning a little bit about economics, sociology or epidemiology, for example, can be a dangerous thing, if one begins to view all law from the perspective of that discipline alone.99 in some cases, the new disciplinary perspective overtakes the law, reversing their roles. if that happens, the law can be seen simply as a tool to achieve the 97 in this respect, health law resembles emergency medicine, which requires knowledge of many medical specialties. the medical profession did not recognize emergency medicine as a distinct specialty for many years, partly because of its applied nature. see generally brian j. zink, anyone, anything, anytime-a history of emergency medicine (2005). 98 the potential for conflicts of interest to create bias in biomedical research is well known. see, e.g., bernard lo, conflicts of interest in medical research, education, and practice 195 (2009); lee friedman & elihu richter, relationship between conflicts of interest and research results, 19 j. gen. internal med. 51 (2004); david korn, conflicts of interest in biomedical research, 284 jama 2234 (2000); dennis thompson, understanding financial conflicts of interest, 329 new engl. j. med. 573 (1993). 9 stevens call this a "monocausal vision of the legal system." stevens, supra note 50, at 272. see ronald chen & jon hanson, categorically biased: the influence of knowledge structures on law and legal theory, 77 s. cal. l. rev. 1103, 1133-39 (2003) (discussing how various personal and experiential schemas bias how we process information). 2013 29 indiana health law review goals of the other discipline, rather than a field with its own values and goals.oo a different kind of bias may arise from one's philosophy of law or personal ideology.10 although this is hardly unique to health law, health law scholarship may have more opportunities to fall prey to such bias, because it examines so many controversial social issues on which most people have strong opinions. it can be difficult to maintain a truly neutral perspective when analyzing laws or doctrines that affect the outcome of an issue important to the scholar.102 this is especially risky in applied fields like health law, where scholars may have a somewhat shallow understanding of the doctrine that applies to a hot-button issue and neglect to adequately analyze precedent and arguments that contradict a preferred interpretation.10 3 it 100 see david m. trubek, the place of law and social science in the structure of legal education, 35 j. legal educ. 483 (1985). for example, the concepts of law and economics added a valuable perspective to legal analysis, but some adherents began to argue that law itself should conform to classical microeconomic theory. teles, supra note 95, at 90-134. see ann southworth, lawyers of the right: professionalizing the conservative coalition 130-48 (2008) (describing the federalist society and the development of a conservative movement to change constitutional law). another example can be found in public health law, where some scholars see the law as simply a tool to achieve health, regardless of other goals, such as justice and liberty. for a critique of this approach, see wendy k. mariner, law and public health: beyond emergency preparedness, 38 j. health l. 247, 279-284 (2005). 101 see norman g. levinsky, nonfinancial conflicts of interest in research, 347 new engl. j. med. 759 (2002). 102 see daniel kahneman, thinking, fast and slow (2011) (describing theories and empirical research in psychology demonstrating how people often fail to analyze complex questions or accept evidence that contradicts their experience, biases or preferences). 103 compare, e.g., leonard h. glantz & george j. annas, handguns, health, and the second amendment, 360 new engl. j. med. 2360, 2361-63 (2009) (noting that the supreme court had not specifically decided whether the second amendment protected an individual or collective right to bear arms before district of columbia v. heller, 554 u.s. 570 (2008)), with lawrence 0. gostin, the constitutional right to bear arms, 300 jama 1575 (2008) (noting that earlier cases were understood to limit the second amendment's protection to a collective right to maintain a militia). vol. 10:130 did legal education fail health reform? can be easy to convince ourselves that our preferred understanding of doctrine or precedent is the indisputably correct interpretation, especially where precedent is limited and open to interpretation.10 4 some constitutional law scholars seem to have succumbed to this error in arguing about the scope of the commerce clause during the aca litigation. 105 strong convictions about the correct interpretation of law can lead to advocacy. of course, practicing lawyers properly advocate for their clients, and make clear that they are doing so. scholarship is a different matter. it should offer honest, balanced analysis that recognizes different approaches and opinions. scholarship does not preclude arguing for a particular interpretation or approach, but arguments are not statements of fact. there should be no hidden agendas in scholarship. when scholarship presents a preferred interpretation as fact or doctrine, it is poor scholarship.106 it may also cross the line into advocacy. if it 104 soo, e.g., memorandum from jay bybee, assistant attorney general of the united states for alberto gonzales, counsel to the president (aug. 1, 2002), available at http://dspace.wrlk.org/doc/bitstream/2041/70964/00355_020801_001displ ay.pdf; memorandum from jay s. bybee, assistant attorney general of the united states for john rizzo, acting general counsel of the central intelligence agency (aug. 1, 2002), available at http://dspace.wrlc. org/doc/bitstream/2041/70967/00355_020801_004display.pdf memorandum from john c. yoo, deputy assistant attorney general, u.s. department of justice for william j. haynes, ii, general counsel of the [u.s.] department of defense (mar. 14, 2003), available at http://www.aclu.org/pdfs/safefree/yoo-army-torture-memo.pdf. see also jack goldsmith, the terror presidency (2007) (noting that these memorandums were later withdrawn). 105 brian leiter, why did most legal scholars, liberal and conservative, fail to realize that the supreme court might take the silly arguments against the "individual mandate" seriously?, brian leiter's law school reports, available at http://leiterlawschool.typepad.com/ leiter/2012/04/why-did-most-legal-scholars-liberal-and-conservative-failto-realize-that-the-supreme-court-might-ta.html. 106 see for example matthew l. myers, protecting public health by strengthening the food and drug administration's authority over tobacco products, 343 new engl. j. med. 1806, 1808 (2000), for a discussion of how health lawyers believed, before the food drug and 2013 31 indiana health law review fails to disclose its advocacy goal, it can be seen as deceptive. scholars in the health law field have many tempting opportunities to write as advocates, because the health care system has so many issues of public importance on which people hold strong views. when scholars write articles, as opposed to advocacy or opinion pieces, on such topics, it is essential to remain open-minded and use one's critical analysis skills to recognize facts and arguments that challenge one's preferred outcome. this is especially important in health law, where decision makers may rely on health law scholarship to develop policy far more than they may rely on more esoteric scholarship on legal theory. v. a broader vision for health law the carnegie report's first recommendation for improving legal education was to develop an integrated curriculum with 3 goals: (1) the teaching of legal doctrine and analysis, which provides the basis for professional growth; (2) introduction to the several facets of practice included under the rubric of lawyering, leading to acting with responsibility for clients; and (3) exploration and assumption of the identity, values and dispositions consonant with the fundamental purposes of the legal profession. integrating the three parts of legal education would better prepare students for the varied demands of professional legal work. 107 cosmetic act was amended to authorize the fda to regulate tobacco, that the fda already had statutory authority to regulate the tobacco industry and were surprised when the supreme court found that the fda's authority to approve only safe and effective new drugs could not include tobacco in fda v. brown & williamson tobacco corp., 529 u.s. 120 (2000). 107 william m. sullivan, anne colby, judith welch wegner, lloyd bond & lee s. shulman, educating lawyers: preparation 32 vol. 10:1 did legal education fail health reform? one need not accept the report's specific critiques or conclusions to recognize that health law offers a good model for a law school curriculum that integrates knowledge, analysis, theory, attention to context, practical application, values, and meaningful change. a common theme underlying many proposals to reform legal education is that of increasing attention to the role of lawyers in society: to inculcate in students an understanding of the obligation of lawyers to the rule of law and the importance of justice overall. too often the lawyer's role is understood narrowly, focusing only on the ethics of the private practice of law.108 if law is a profession, it must stand for something, and that something should be justice. 109 moreover, justice is for everyone, not only a client. so, a deeper understanding of the role of lawyers and the rule of law requires expanding our intellectual horizons to encompass the role of law in society. this begs the question of what law is; a question well beyond the scope of this essay. nevertheless, it is worth asking whether we can honestly say that law is a science with formal rules and neutral, objective principles of justice. i think not as long as there are differing theories of justice and no universally accepted standard for choosing among them.110 the periodic waves of jurisprudential scholarship for the profession of law, summary 8 (the carnegie found. for the advancement of teaching ed. 2007) [hereinafter carnegie summary]. the carnegie report recognized the difficulty of implementing its recommendations. remaking a curriculum is a complicated undertaking that may require years of work. human beings are naturally reluctant to change what they are doing. see also carsik, supra note 37, at 814 (noting that in academia, curriculum changes can be perceived as a threat to the value of the faculty's work, while there may also be personal rewards for working with other faculty, learning their perspectives, and discovering new insights). 108 see bethany rubin henderson, asking the lost question: what is the purpose oflaw school. 53 j. legal educ. 48 (2003). 109 carnegie report, supra note 37, at 131; m mccrate report, supra note 37, at 140-41 ("striving to promote justice, fairness, and morality" is one of the four fundamental values of the legal profession). 110 the vast literature on theories of justice is testimony to the multitude of different perspectives. see, e.g., michael j. sandel, 2013 33 indiana health law review from different perspectives are evidence of an unsettled system. so, what can we teach? if law constructs rules based on justice and fairness, we can, and often do, turn to political economy, economics, social theory, and moral philosophy to try to determine what is fair. each of these fields offers important insights and perspectives to enrich our thinking. but, each also has its own ambiguities and internal conflicts, so that the same lack of consensus can reemerge in different jargon: no ultimate neutral standard of justice. law professors, not fully expert in those fields, can be understandably nervous about relying on any single approach for ultimate insights. for me, the only realistic answer is to live with the messiness of law. it means giving up the idea that there necessarily is a right answer, while continuing the search. we need to keep asking why we should accept a legal principle. what purpose does it serve, not only in principle, but in people's daily lives? it means analyzing doctrine in the context of the world in which law applies and its consequences for real people. it means recognizing the need for change, interacting with people who are affected by the law (and the absence of law), and, most importantly, explicitly considering the social, financial, and moral implications of law not merely in theory, but as experienced by all those affected."' in his president's report to the board of overseers of harvard university for 1981-82, derek bok aptly compared the legal system to the health care system, finding both to be increasingly sophisticated, but also complex, costly and justice (2009); catharine a. mackinnon, toward a feminist theory of the state (1989); ronald dworkin, law's empire (1986); john hart ely, democracy and distrust: a theory of judicial review (1980); edgar bodenheimer, jurisprudence: the philosophy and method of the law (rev. ed. 1974); robert nozick, anarchy, state, and utopia (1974); john rawls, a theory of justice (1971). ni see generally roberto mangabeira unger, law in modern society (1976); harold lasswell & myres mcdougal, legal education and public policy professional training in the public interest, 53 yale l. j. 203 (1943). 34 vol. 10:1 did legal education fail health reform? maldistributed across the population.112 his conclusion remains true today: "the blunt, inexcusable fact is that this nation, which prides itself on efficiency and justice, has developed a legal system that is the most expensive in the world, yet cannot manage to protect the rights of its citizens."113 although there may be no more court cases per capita than in the past, there are more statutes and regulations to negotiate, just as there are more medical tests and therapies for disease. like medical students, law students often choose lucrative private practice specialties rather than public service, partly to repay the increasing cost of their educations. specialties in both medicine and law are more rewarding, both in money and prestige, than primary care and general practice. the growth of large multistate and multinational law firms mirrored the consolidation of both hospital systems and insurance companies, resulting in higher compensation for partners and associates and higher fees for clients, 114 although the recession has dampened that trend. 115 major law firms concentrate on providing services at rates that only large organizations and wealthy individuals can pay. low and middle-income families and small businesses cannot afford much justice. legal service organizations and public defenders are generally underpaid while reaching only a fraction of those who need their help. in this respect, the health care system performs somewhat better, because public and private health insurance, as well as uncompensated care pools, are available. 112 derek c. bok, a flawed system of law practice and training, harvard magazine 38, 38, 40 (may-june 1983), reprinted in 33 j. legal educ. 570, 570, 572 (1983). 113 id. at 41. 114 carrie menkel-meadow, culture clash in the quality of life in the law: changes in the economics, diversification and organization ofla wyering, 44 case w. res. l. rev. 621, 628, 631 (1994). 115 america's law schools and frms: trouble with the law, the economist, nov. 13, 2010, at 79, available at http://www. economist.com/node/17461573. 2013 35 indiana health law review bok's report sparked many commentaries, but few concrete changes. 116 here, health law may offer some valuable perspectives. because health lawyers often deal with issues of equitable access to health care, they should be particularly attuned to the ways in which laws promote or hinder access to justice. thus, they may be alert to problems of justice and fairness in the legal system.1 17 the affordable care act lays out a program for near universal access to health care. although the aca does not directly control the health care costs that created pressure for reform, it puts the cost of care on the agenda for future experiments and reforms. 118 perhaps it is time to initiate reform not only in legal education, but, as bok urged, in the legal system as a whole. real reform would go beyond ongoing efforts to improve law school curricula. reform goals should include enabling access to essential legal services for the entire population. for example, adapting the model of medical residencies for graduates of medical schools, creating a one or two year residency program in which law graduates spend time working for low and middle-income clients under the supervision of licensed attorneys would give graduates important practical experience and expand the services available to those in need.119 to integrate such training and experience into the 116 see, e.g., deborah l. rhode, the rhetoric of professional reform, 45 md. l. rev. 274 (1986); roger cramton, the trouble with lawyers (and law schools), 35 j. legal educ. 359 (1985); david m. trubek, comments on the bok report a strategy for legal studies: getting bok to work, 33 j. legal educ. 586 (1983); alfred f. conrad, the law school's responsibility for the quantity of justice, 33 j. legal stud. 600 (1983); stephen gillers, great expectations: conceptions of lawyers at the angle ofentry, 33 j. legal educ. 662 (1983). 117 see generally jerold s. auerbach, unequal justice: lawyers and social change in modern america (1976). 118 see an act improving the quality of health care and reducing costs through increased transparency, efficiency and innovation, 2012 mass. acts, in which massachusetts enacted payment reform legislation intended to slow the growth of health care costs, only a few years after enacting health care reform. 119 for early recommendations for similar clinical years, see carnegie, report, supra note 37, at 192; stevens, supra note 50, at 242-3. an alternative might be to borrow an approach from european legal vol. 10:136 did legal education fail health reform? curriculum before graduation, the third year of law school could be transformed into an analog of medical school clerkships. third year students could work in government agencies, non-profit, and legal service organizations. there should be plenty of opportunities for such placements in the health care system, but similar opportunities could surely be found in education, housing, family law, energy and environmental placements. in this way, legal education might begin to respond more effectively to both the ivory tower and social justice critiques and improve access to justice for everyone. vi. conclusion arguments over the constitutionality of the aca in the courts, in public debates, in scholarly articles, and blogs illustrate the pervasiveness of health law issues in society. it also demonstrates that many participants in that debate, both those for and against the aca, remained wedded to theories that have become disconnected from twenty first century realities. legal education may have something to answer for in this respect. the more law moves away from strict principles into nuanced adjustments to new circumstances, the more lawyers will need to understand the circumstances. as the search for more affordable, responsive, and responsible legal education continues, it is worth emulating the best features of health law. health law scholars should be proactive in translating their successes into broader curriculum changes, especially attention to context, both in theory and practice. because the context includes how law affects society at large, meaningful reform should adopt as its ultimate goal extending affordable access to justice for all. education, which requires law graduates who pass a partial licensure examination to practice for two or three years (much like a medical residency) and then take another examination to qualify for full licensure. 2013 37 the supreme court’s overreaching preemption interpretation and its consequences: granting generic drug manufacturers legal immunity through “the duty of sameness” in mutual pharmaceutical co. v. bartlett and pliva v. mensing tyler w. olson* i. introduction ................................................................. 770 a. issue ........................................................................... 772 b. roadmap ..................................................................... 773 ii. the law and regulatory rules of the pharmaceutical industry ............................................... 774 a. historical background ............................................... 774 1. patent law .............................................................. 774 2. the federal food and drugs act, the food drug and cosmetics act, and hatch-waxman act .................... 777 b. current regulatory laws affecting pharmaceutical drugs ............................................................................... 781 iii. preemption doctrine analysis ................................ 783 a. preemption doctrine .................................................. 783 iv. case law, indiana statutory dissemination, and recourse available for generic drug consumers .... 786 a. wyeth, pliva and bartlett ......................................... 786 1. wyeth – no state tort law preemption from fda’s brand-name drug regulations .................................. 786 2. pliva – state tort law preemption for failure-towarn claims against generic manufacturers .......... 788 3. bartlett state tort law preemption for design defect claims against generic manufacturers ......... 792 b. indiana’s statutory analysis and the importance of state law ........................................................................ 795 c. recourse available to generic drug consumers ...... 800 1. option one suing the name brand manufacturer ..................................................................................... 801 * j.d. candidate, 2015, indiana university robert h. mckinney school of law; b.a., 2011, ohio state university. http://dx.doi.org/10.18060/3911.0008 770 indiana health law review vol. 12:2 2. option two – suing the generic drug manufacturer for misbranding ........................................................... 804 3. option three – paying for protection through brand name drugs ................................................................ 805 4. option four legislative amendment .................. 806 v. conclusion ................................................................... 809 i. introduction national health expenditures in the united states are projected to exceed $3.093 trillion in 2014.1 prescription drug sales accounted for 8.9% of all national health expenditures in 2013. 2 in 2014, these drug sales are projected to exceed $275.9 billion of national health expenditures.3 the significant pharmaceutical drug sales are due, in large part, to the increasing commonality of treatment; in 2013, nearly seven in ten americans took prescription drugs for treatment.4 most pharmaceutical drugs brought to market are subject to patent protection. this limited protection provides incentives for drug development and research. however, following patent expiration it is common that brand-name drugs lose their market share to generic alternatives.5 these generic drugs provide more affordable 1 national health expenditure projections 2012-2022, center for medicare & medicaid services, http://www.cms.gov/researchstatistics-data-and-systems/statistics-trends-andreports/nationalhealthexpenddata/downloads/proj2012.pdf (last visited mar. 16, 2015). 2 id. 3 id. 4 the most common prescription drugs taken were antibiotics, antiasthmas, painkillers, and antidepressants. nearly 7 in 10 americans take prescription drugs, mayo clinic, olmstead medical center find, mayo clinic (june 19, 2013), http://newsnetwork.mayoclinic.org/ discussion/nearly-7-in-10-americans-take-prescription-drugs-mayoclinic-olmsted-medical-center-find [hereinafter nearly 7 in 10 americans]. 5 a “generic” drug in this note refers to pharmaceutical equivalents of brand-name fda approved drugs that exist post patent-expiration. for a full list of approved drugs with equivalence evaluations, see 2015 771 the supreme court’s overreaching preemption interpretation and it’s consequences treatment options versus their brand-name counterparts.6 the savings of switching to generic drugs can be significant; for example, opting for generic drugs versus their brandname counterparts saved consumers an estimated $33 billion in 2013. 7 external forces are known to influence consumer choices for prescription filing8 and an estimated 90% of prescription drugs written in 2007 were generic.9 the u.s. constitution plays an important role of safeguarding fundamental interests of citizens. it establishes “a system of dual sovereignty between the states and the federal government.”10 as it relates to the pharmaceutical industry, this dual sovereignty allows the federal and state government the ability to enact protection laws for its citizens. thus, the constitution grants states the power to enact laws subject to the supremacy clause..11 states have enacted tort laws that provide protection to its citizens. in the pharmaceutical industry, state tort laws “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” 12 orange book, approved drug products with therapeutic equivalence evaluations, u.s. food & drug admin, http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm (last visited mar. 16, 2015). 6 tod cooperman, what you need to know about generic drugs (apr. 8, 2013), http://www.doctoroz.com/videos/what-you-need-knowabout-generic-drugs. 7 danielle l. steele, the “duty of sameness” as a shield--generic drug manufacturers’ tort liability and the need for label independence after pliva, inc. v. mensing, 43 seton hall l. rev 441, 442-43 (2013) (citing effects of using generic drugs on medicare’s prescription drug spending cong. budget off. (sept. 15, 2010), http://www.cbo.gov/sites/ default/files/cbofiles/ftpdocs/118xx/doc11838/09-15prescriptiondrugs.pdf). 8 see id. at 443 (stating that “[private pharmaceutical benefit management companies] strategically manipulate pricing and coverage in order to influence patient behavior in prescription fulfillment.” (citations omitted)). 9 id. at 442. 10 gregory v. ashcroft, 501 u.s. 452, 457 (1991). 11 u.s. const. art. vi cl. 2. 12 wyeth v. levine, 555 u.s. 555, 579 (2009). 772 indiana health law review vol. 12:2 these state tort laws also provide (sometimes limited) compensation to injured parties in an attempt to redress injuries.13 additionally, these tort laws help to supplement gaps present in federal law, such as the lack of a private cause of action in the food, drug, and cosmetic act (“fdca”).14 the long held constitutional right of permitting tort law causes of action for injured parties might no longer be available to generic drug consumers. two recently decided supreme court cases have established precedent holding that while brand name drug manufacturers face liability for failure-to-warn and product liability claims, generic drug manufacturers will not face liability so long as it complies with the duty of sameness as defined in the fdca.15 this precedent is preventing innocently injured consumers from being able to seek legal recourse against liable generic drug manufacturers. addressing this issue or providing alternative legal courses remains paramount to protect consumer needs. a. issue the two decisions issued by the supreme court will have debilitating effects on generic drug consumers in the u.s. marketplace. this precedent is likely to result in denying individuals who take generic drugs the ability to legally redress their injuries. this is significant because an estimated 80% of consumers opt for generic drug treatment. in pliva v. mensing, the court expanded the scope of the impossibility preemption. 16 this expansion granted immunity to generic drug manufacturers from state law failure-to-warn claims.17 in pliva, two individuals that had developed tardive dyskinesia, a severe abnormal and 13 id. 14 see merrell dow pharm. inc. v. thompson, 478 u.s. 804 (1986) (reasoning that fdca violations provide no federal cause of action). 15 21 u.s.c. §§ 355(j)(2)(a)(ii)-(iii) (2015). 16 pliva, inc. v. mensing, 131 s.ct. 2567 (2011). 17 id. at 2569. 2015 773 the supreme court’s overreaching preemption interpretation and it’s consequences uncontrollable face movement disorder,18 were left without legal recourse.19 in mutual co. pharmaceutical v. bartlett, the court unnecessarily expanded the reach of the preemption doctrine.20 the injured plaintiff purchased an affordable generic drug to treat her life threatening dermatologic disorder. however, as a result of the court’s preemption interpretation, she was left without legal recourse to address her debilitating injuries.21 these recent supreme court decisions raise the need for legislative action and/or statutory amendment. the food and drug administration (“fda”) acts as a gatekeeper in “protect[ing] the public health by assuring the safety, efficacy, and security of human and veterinary drugs . . . .”22 the fda remains responsible “helping to speed innovations that make medicines more effective, safer, and more affordable . . . .”23 as a result of these two recent decisions, the fda’s responsibility is subject to this large gap that is preventing innocent generic drug consumers from seeking legal recourse to address their injuries.24 b. roadmap this note discusses the ramifications of three recently decided supreme court cases dealing with federal preemption in the prescription drug marketplace: wyeth v. 18 see tardive dyskinesia, medlineplus, http://www.nlm.nih.gov/ medlineplus/ency/article/000685.htm (last visited mar. 6, 2015) (“tardive dyskinesia is a disorder that involves involuntary movements . . . , [especially of] the lower face. tardive means delayed and dyskinesia means abnormal movement.”)). 19 pliva, inc., 131 s.ct. at 2569. 20 mut. pharm. co., inc. v. bartlett, 133 s.ct. 2466, 2472 (2013) (the victim developed epidermal necrolysis, a skin eating bacteria). 21 id. 22 about fda: what we do, u.s. food & drug admin., http://www.fda.gov/aboutfda/whatwedo/ (last updated aug. 5, 2014). 23 id. 24 see therapeutic drug use, center for disease control & prevention, http://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm (last visited mar. 16, 2015) (in 2007, 48.5% of persons in the u.s. reported using least one prescription drug in the past thirty days). 774 indiana health law review vol. 12:2 levine,25 pliva v. mensing,26 and mutual co. pharm. v. bartlett. 27 to facilitate an understanding of the issue discussed, section ii explains the statutory history of both patent law and federal regulations applicable to generic and brand name pharmaceutical manufacturers. section ii will also discuss the procedural and regulatory thresholds that generic drug manufacturers are required to satisfy to bring its drugs to market. section iii will explore the preemption doctrine, delving into potential preemption scenarios that may arise as a legal argument. section iv will analyze these three supreme court cases and it will apply this flawed precedent to indiana by applying this precedent to previously decided indiana cases. finally, section iv will explore possible options available to injured generic drug consumers. ii. the law and regulatory rules of the pharmaceutical industry to understand the statutory structure of pharmaceutical law and market entry barriers pharmaceutical drugs face, it is important to understand the reasoning underlying the creation of the acts themselves. this section briefly explores u.s. patent law as it relates to generic and brand name drugs, it provides a brief history of acts relevant to the pharmaceutical industry, and it explores the barriers to entry applicable to brand name and generic drug manufacturers. a. historical background 1. patent law the original article of the constitution provides the origin of patent protection.28 patents play a central role in 25 wyeth v. levine, 555 u.s. 555 (2009). 26 pliva, inc. v. mensing, 131 s.ct. 2567, 2570 (2011). 27 mut. pharm. co. inc., v. bartlett, 133 s.ct. 2466 (2013). 28 u.s. const. art. i, § 8, cl. 8. 2015 775 the supreme court’s overreaching preemption interpretation and it’s consequences the creation and development of pharmaceutical drugs. 29 by granting limited monopoly powers, these patents provide monetary incentives for companies to invest in researching and developing new drugs to bring to market. 30 this limited monopoly is important in helping brand name drug manufacturers recoup the research and development costs of new drugs which may exceed $2.5 billion. 31 it is important to note, however, that this patent protection is with limits. for example, the bolar exemption allows a generic drug manufacturer to start researching and testing for drug approval pre-patent expiration.32 patent protection is authorized by article 1, section 8, clause 8 of the u.s. constitution, which states in part, “[t]o promote the progress of science and useful arts, by securing for limited times . . . the exclusive right to their respective writings and discoveries.”33 a patent is a property right 29 patent faqs, u.s. pat. & trademark off., http://www.uspto.gov/inventors/patents.jsp (last visited mar. 16, 2015) (patents provide security on the idea for a limited duration). 30 35 u.s.c. § 154(a)(2) (2015) (the patent term is 20 years from the filing date). 31 pr tufts csdd 2014 cost study, tufts csdd, http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_stud y (last visited mar. 30, 2015). 32 see roche prods., inc. v. bolar pharm. co., inc., 733 f.2d 858 (fed. cir. 1984), superseded by statute as stated in warner-lambert co. v. apotex corp. 316 f.3d 1348 (fed. cir. 2003) (the bolar exemption also allows generic drug manufacturers to perform research and tests in preparation for regulatory approval prior to patent expiration, and this exemption immunizes the generic manufacturers against patent infringement suits. the rationale is for the bolar exemption is to allow generic drug manufacturers the opportunity to conduct clinical trials on patented products before the products patent has expired). there are other exceptions and protections granted to generic drug manufacturers. for example, a paragraph 4 (often referred to as p4) certification is a form that generic firms can use to challenge current patents. if the brand-name manufacturer sues the generic filing p4 party, and it is determined that the patent is indeed invalid, the generic manufacturer is rewarded with a valuable 180-day marketing exclusivity period. the p4’s origin traces back to the hatch-waxman act. 33 u.s. const. art. i, § 8, cl. 8 (congress shall have power “[t]o promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective 776 indiana health law review vol. 12:2 granted by the u.s. to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the [u.s.] or importing the invention to the [u.s.]” for a limited time.34 for a patent to be held valid, there are many requirements. generally, the patent must be novel, useful, and non-obvious to a person ordinarily skilled in the art.35 the patent subject matter must also be patentable36 and specified written materials must be part of every patent application.37 the original patent holder may be able to file for an extension on their monopoly powers. these extensions are subject to their own onerous requirements. following the expiration of the patent term, whether or not an extension has been granted, generic drug manufacturers are able to writings and discoveries.”). 34 35 u.s.c. § 154(a)(1) (2015). 35 appendix l consolidated patent laws, uspto.gov (last visited mar. 16, 2015), http://www.uspto.gov/web/offices/pac/mpep/ consolidated_laws.pdf. see 35 u.s.c. § 102 (2015) (novelty); see also cornell univ. l. sch., overview, legal information institute, http://www.law.cornell.edu/wex/patent (last visited mar. 16, 2015) (hereinafter overview) (generally, novelty requires that the invention wasn’t known or used by others in the united states, or patented/described in print or publication in the united states or other country. to meet this, the invention must be new compared to prior art). see 35 u.s.c. § 101 (2015) (utility); see also overview (generally, a patent does not have to have any economic value whatsoever, but it is required that the utility asserted in the application be credible, specific, and substantial). see 35 u.s.c. § 103 (2015) (non-obvious); see also graham v. john deere co. of kansas city, 383 u.s. 1 (1966) (establishing the test for non-obvious as whether the subject matter sought to be patented and prior art as such that the subject matter as a whole would’ve been obvious to a person having ordinary skill in the art at the time the invention was made). 36 35 u.s.c. § 103 (2015). generally, laws of nature, physical phenomena and abstract ideas are not patentable. the distinction between patentable and unpatentable subject matter is between products of nature, living or not, and human-made inventions. 37 35 u.s.c. § 112 (2015). for a more detailed discussion of specific written material requirements, see patent, legal info. inst., https://www.law.cornell.edu/wex/patent (last visited mar. 30, 2015) (“enablement is understood as encompassing three distinct requirements: the enablement requirement, the written description requirement, and the best mode requirement.”). 2015 777 the supreme court’s overreaching preemption interpretation and it’s consequences enter into the drug market through an abbreviated approval process.38 2. the federal food and drugs act, the food drug and cosmetics act, and hatch-waxman act the origin of regulations for health consumer goods was created in 1906. the 1906 passage of the pure food and drugs act (“pfda”) began the fda’s origin as a federal consumer protection agency.39 the fda’s responsibilities have been amended since the initial passage of the pfda and the fda’s current responsibilities in the pharmaceutical industry involve overseeing drug approval and post approval safety.40 the fda acts as a gatekeeper and the agency plays an important role in pharmaceutical regulation.41 prior to the pfda, the “[u]se of chemical preservatives . . . was virtually uncontrolled.”42 manufacturers were not subject to any approval process and could freely enter the market and sell drugs. the pfda passage43 helped address 38 see infra note 40. see also how increased competition from generic drugs has affected prices and returns in the pharmaceutical industry, cong. budget off., http://www.cbo.gov/publication/ 10938?index=655 (last visited mar. 16, 2015) (hereinafter how increased competition has affected prices and returns). 39 about fda: when and why was fda formed?, u.s. food & drug admin., http://www.fda.gov/aboutfda/transparency/ basics/ucm214403.htm (last visited mar. 16, 2015). 40 about fda: office of medical products and tobacco, u.s. food & drug admin., http://www.fda.gov/aboutfda/centersoffices/ officeofmedicalproductsandtobacco/ucm20025997.htm (last visited mar. 16, 2015). 41 steele, supra note 7 at 469 (the united state government and accountability office (“gao”) has raised concerns over the fda’s “management of safety issues for drugs approved for marketing.” the fda staff has “expressed concern about their ability to meet a growing post market workload, with some maintaining that their premarket responsibilities are considered a higher priority.” (citations omitted)). 42 wallace f. janssen, the story of the laws behind the labels, u.s. food & drug admin. (june 1981), http://www.fda.gov/aboutfda /whatwedo/history/overviews/ucm056044.htm. 43 34 stat. 768 (1906) (repealed in 1938 by 21 u.s.c. § 329(a)). 778 indiana health law review vol. 12:2 the uncontrolled industry by prohibiting the manufacturing or interstate shipment of adulterated or misbranded drugs. the pfda also helped by supplementing consumer protections already provided by state regulation and common law liability. 44 after expressing concern about unsafe drugs and fraudulent marketing, congress enacted the federal food, drug, and cosmetic act (“fdca”).45 this required the premarket approval of new drugs by requiring every drug manufacturer to submit a new drug application (“nda”), including all reports and investigations, to the fda for review.46 congress amended the fdca in 1962. 47 this amendment shifted the burden of proof from the fda to the manufacturer to gain drug approval. this amendment also requires manufacturers to prove a drug’s effectiveness by introducing “substantial evidence . . . that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling.”48 furthermore, this amendment added a clause stating that state law would be invalidated only upon a “direct and positive conflict” with the fdca.49 this clause remains important to current preemption analysis and it will be analyzed in depth below. congress sought to facilitate the quicker approval of generic drugs into the marketplace. to streamline the generic drug approval process, congress enacted the drug price competition and patent term restoration act in 1984 (hereinafter the “hatch-waxman act”).50 prior to enacting the hatch-waxman act, generic drug manufacturers were required to undertake the same approval as brand name 44 id. 45 pub. l. no. 75-717, 52 stat. 1040 (1938). 46 id. 47 pub.l. no. 87-781, 76 stat. 780 (1962) (codified as amended in scattered sections of 21 u.s.c.). 48 id. 49 wyeth v. levine, 555 u.s. 555, 567 (2009) (citations omitted)(emphasis added). 50 drug price competition and patent term restoration act, pub. l. no. 98-417, 98 stat. 1585 (codified as amended in scattered sections of 21 u.s.c.). 2015 779 the supreme court’s overreaching preemption interpretation and it’s consequences drug manufacturers. this demanding approval process deterred the drug approval applications by generic drug manufacturers because the cost of such approvals would rarely be outweighed by the profit potential. this act (and subsequent amendments) created the abbreviated new drug application (“anda”), a rule that expedites generic drug approval by permitting reliance on brand name drug data.51 it is important to note that the hatch-waxman act focused largely on small molecule drugs (“smd’s”) versus biologics. these smd’s are different in that they are often small (sometimes a single molecule), they are produced by chemical synthesis and they are often stable, whereas biologics are large (molecule mixtures), complex, produced by living cell cultures and difficult to control.52 while generic drug approval is available, such analysis is not the subject of this note. generic drug approval is available for biologics.53 to provide a brief summary, the biologics price competition and innovation act (which is included in the patient protection and affordable care act of 2009) helped address the availability of biologics by “allow[ing] the submission of a biological license application (bla) for a biosimilar or interchangeable biological.”54 this regulatory scheme mirrors the anda process by 51 see generally 21 c.f.r. § 314 et seq. (2015). 52 small molecule drugs versus biological drugs, generics & biosimilars initiative (june 29, 2012), http://www.gabionline.net/biosimilars/research/small-molecule-versusbiological-drugs. 53 biologics is a large and complex issue that has been the topic of several articles, commentaries, and studies which analyze the biologics act, the similarities this act has to the anda process, and the complexities of biologics. see brenda f. gehani, the biologics act: hopes for access to generic biologics may instead be a catalyst for new innovation, 20 annals health l. 170 (2011). see also parker tresmer, interests in the balance fda regulations under the biologics price competition and innovation act, 16 ulca j. l. & tech. 1 (2012); sara margolis, destined for failure? an analysis of the biologics price competition and innovation act of 2009, 2013 colum. bus. l. rev. 209 (2013). 54 biologics price competition and innovation act, democratic pol’y & comm. center, http://www.dpc.senate.gov/healthreformbill/ healthbill70.pdf (last visited mar. 18, 2015). 780 indiana health law review vol. 12:2 “[p]ermit[ting] the fda, following a public process, to issue guidance related to the approval of biosimilar and interchangeable biological products.”55 when the hatch-waxman act was enacted in 1984, generic drugs accounted for 19% of all drug sales in the united states.56 the hatch-waxman act’s anda process allowed generic drug manufacturers to enter the marketplace without the restraints new brand name drug manufacturers face. as such, it was not long before generic drugs comprised the majority of the market. generic drug approval costs dropped substantially due to the anda process. 57 as a result, the generic drug approval applications and sales steadily increased. currently, 90% of drug prescriptions are filled with generic counterparts.58 the most recent fdca amendment relating to pharmaceuticals was passed in 2007 when congress “adopted a rule of construction to make it clear that manufacturers remain responsible for updating their labels.”59 the food and drug administration amendments act (“fdaaa”) increased the burden placed on drug manufacturers.60 importantly, the fda granted statutory authority under the fdaaa (and other parts of the fdca) allowing it to require drug manufacturers to change drug labels based upon information discovered after a drug has been approved for market.61 that is because manufacturers 55 id. (noting that this act “[a]wards brand manufacturers and innovators 12 years of data exclusivity from the approval date of the product.” this will essentially expand the viable monopoly sale time of the brand-name biologic by preventing generic companies from relying on their previous research). 56 how increased competition has affected prices and returns, supra note 35. 57 steele, supra note 7 at 451 (noting that “the average cost of bringing a generic to market is under $2 million, less than a quarter of the average costs associated with novel drugs.”). 58 steele, supra note 7 at 442. 59 wyeth, 555 u.s. 555, 568 (2009) (citations omitted) (emphasis added). 60 pub. l. no. 110-85. 121 stat. 83 (2007). 61 food and drug administration amendments act of 2007, pub. l. no. 110-85, 121 stat. 823 (codified as amended in scattered sections of 21 u.s.c.). 2015 781 the supreme court’s overreaching preemption interpretation and it’s consequences who have greater “access to information about their drugs” than the fda retain the ultimate responsibility for the safety of their products. 62 therefore, this requirement would place the burden on drug manufacturers and it provides incentives for manufacturers to provide wholly accurate and timely updates because it is their potential liability for failing to do so. b. current regulatory laws affecting pharmaceutical drugs under current law, if a generic drug is identical to an fda approved brand-name drug in several aspects, it may be approved without the same onerous requirements of brand-name drugs.63 first, the proposed generic drug must be chemically equivalent to the approved brand-name drug. 64 this requires the generic drug to have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as the approved brand-name drug. 65 second, the generic drug must be “bioequivalent” to the approved brand-name drug.66 to be considered bioequivalent, a generic drug has to have the same “rate and extent of absorption . . .” as its brandname counterpart. 67 third, generic drug manufacturers must show that the “labeling proposed for the new drug is the same as the labeling approved for the listed drug . . . .”68 this labeling requirement has been argued (and interpreted) as meaning generic drug manufacturers are not able to unilaterally change their labels to strengthen warnings.69 the fda approves generic drugs only if they are determined “safe for use” under “conditions of use 62 wyeth, 555 u.s. at 578-79. 63 bartlett, 133 s.ct. at 2471. 64 21 u.s.c. § 355(j)(2)(a)(ii) (2015). 65 id. §§ 355(j)(2)(a)(ii)-(iii) (2015). 66 id. § 355(j)(2)(a)(iv). 67 id. § 355(j)(8)(b)(i). 68 id. § 355(j)(2)(a)(v). 69 pliva, inc. v. mensing, 131 s.ct. 2575 (2011). 782 indiana health law review vol. 12:2 prescribed, recommended, or suggested in the proposed label thereof.”70 the risk of harm must be outweighed by the “probable therapeutic benefits . . . .”71 once a generic drug is approved, a manufacturer is prohibited from making any major changes to the quantitative or qualitative formulation of the drug, including but not limited to its active ingredients or specifications included in the approved application.72 therefore, generic drugs are required to have the same dosage form, strength, active ingredients, and route of administration as their brand-name counterpart.73 in an attempt to continually promote drug efficacy and safety, both anda’s and nda’s are required by federal regulations to comply with reporting and monitoring requirements regarding drug safety. 74 failure to comply with these regulations by establishing and maintaining records may result in the fda “withdraw[ing] approval of the application and, thus, prohibit[ing] continued marketing of the drug product that is the subject of the application.”75 furthermore, to facilitate consumer safety, drug manufacturers may “add or strengthen a contraindication, warning, precaution, or adverse reaction . . .” without prior approval so long as they notify the fda thirty days prior to drug distribution. 76 it would appear that the previous responsibility would hold generic drug manufacturers liable for failing to update their labels. however, as discussed below, the duty of sameness absolves generic drug manufacturers of liability. 70 21 u.s.c. § 355(d) (2015). 71 fda v. brown & williamson tobacco corp., 529 u.s. 120, 140 (2000). 72 21 c.f.r. § 314.70(b)(2)(i) (2015). 73 21 u.s.c. § 355(j) (2015). 74 21 c.f.r. § 314.98(a) (“[e]ach applicant having an approved abbreviated new drug application . . . that is effective shall comply with the requirements of §314.80 regarding the reporting and recordkeeping of adverse drug experiences.”). see 21 c.f.r. § 314.80 for requirements. 75 21 c.f.r. § 314.80(j) (“withdrawal of approval. if an applicant fails to establish and maintain records and make reports required under this section, fda may withdraw approval of the application and, thus, prohibit continued marketing of the drug product that is the subject of the application.”). 76 21 c.f.r. § 314.70(c)(6)(iii) (2015). 2015 783 the supreme court’s overreaching preemption interpretation and it’s consequences iii. preemption doctrine analysis the preemption doctrine plays an important role in understanding the shortcomings of these two recently decided supreme court cases, pliva and bartlett. to facilitate the understanding of this doctrine, this section will explore the origin of the preemption doctrine while providing scenarios where the doctrine may be applicable. a. preemption doctrine the preemption doctrine originated through judicial interpretation from the supremacy clause. the supreme court first relied on the supremacy clause in the 1796 case ware v. hylton.77 the supremacy clause states, in part, that the “constitution, and the laws of the united states . . . shall be the supreme law of the land . . . .”78 therefore, the supremacy clause has federal law preempt (or reign supreme) over state law when two laws conflict. in circumstances where the supremacy clause is applicable, the state law that conflicts with the federal law is generally “without effect.”79 federal preemption is often divided into two categories: express preemption and implied preemption. 80 express preemption exists when there is an explicit statutory provision stating that federal law will supersede law. 81 therefore, when an explicit statutory provision exists stating federal law supersedes all other laws, the general inquiry is whether the state law falls with the scope of the federal law. 82 to illustrate, the employee retirement 77 ware v. hylton, 3 u.s. 199 (1796) (invalidating a virginia law providing for confiscation of debts owed to a british subject under the supremacy clause). 78 u.s. const. art. vi, cl. 2 (emphasis added). 79 maryland v. louisana, 451 u.s. 725, 746 (1981). 80 jennifer s. hendricks, preemption of common law claims and the prospects for fifra: justice stevens puts the genie back in the bottle, 15 duke envtl., l. & pol’y f. 65, 69 (2004). 81 id. 82 id. at 70. 784 indiana health law review vol. 12:2 income security act (often referred to as “erisa”) section 514 expressly preempts all state laws “relating to” employer-sponsored health plans.83 implied preemption exists in three scenarios. first, implied preemption may exist where state law creates an obstacle for compliance with federal law.84 for example, in hines v. davidowitz the court held that pennsylvania’s alien registration system stood “as an obstacle to the accomplishment and execution of the full purposes and objectives of congress[‘] [alien registration act.]”. 85 pennsylvania’s alien registration was preempted by congress’ alien registration act and was held invalid. second, implied preemption may exist where congressional law occupies an entire field so as to create an “inference of federal exclusivity.” 86 for example, in gade v. national solid wastes management association the court determined that an illinois provision applicable to licensing workers who handled hazardous waste materials was preempted by federal occupational safety and health administration regulations because such regulations occupied the whole field of handling hazardous waste material.87 third, implied preemption may occur where it is impossible for one to comply with both federal and state law due to direct conflict between federal and state law.88 for example, if a state law explicitly permits something federal law forbids, a direct conflict would likely exist and state law would probably be preempted.89 it is important to note that raising impossibility preemption is a demanding defense.90 the main inquiry is whether the private party could 83 29 u.s.c. § 1144(a) (2015). for a more detailed erisa analysis, see erisa preemption primer, nat’l acad. for state health pol’y, http://nashp.org/sites/default/files/erisa_primer.pdf ?q=files/erisa_primer.pdf (last visited mar. 20, 2015). 84 hendricks, supra note 80 at 70. 85 hines v. davidowitz, 312 u.s. 52, 68 (1941). 86 hendricks, supra note 80 at 70. 87 gade v. nat’l solid wastes mgmt. ass’n., 505 u.s. 88 (1992). 88 hendricks, supra note 80 at 70. 89 id. 90 wyeth v. levine, 555 u.s. 555, 573 (2009). 2015 785 the supreme court’s overreaching preemption interpretation and it’s consequences independently do under federal law what state law requires of it.91 when state and federal law impose irreconcilable conflicting affirmative requirements, an inquiry into congressional design is unnecessary because congress’ intent to have federal law displace the conflicting state law “is inescapable.”92 because there is a presumption against finding preemption, it is much less common for courts to find preemption than to not.93 congress plays an important role of being the “‘ultimate touchstone’ in every pre-emption case.”94 therefore, courts should defer to congress’ intent in deciding whether preemption should apply. unless it was the clear intent and purpose of congress to have a federal act supersede state law, police powers of the state should not be held preempted.95 furthermore, when congress has legislated in a field traditionally occupied by the states“[t]hat assumption . . . applies with particular force . . . .” 96 therefore, absent direct conflict, courts cannot assume congress intended for preemption to exist. 97 a detailed inquiry into congressional intent should be made, and where a statute contains no explicit preemption command, courts may infer that the administrative agency has a degree of leeway to determine the extent to which “statutes, rules, regulations or other administrative actions have preemptive effect.” 98 these fundamental principles were 91 id. 92 see mut. pharm. co.,133 s.ct. at 2473 (citing florida lime & avocado growers, inc. v. paul, 373 u.s. 132, 142-43 (“a holding of federal exclusion of state law is inescapable and requires no inquiry into congressional design where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.”)). 93 kerry abrams, plenary power preemption, 99 va. l. rev. 601, 608 (2013). 94 medtronic, inc. v. lohr, 518 u.s. 470, 485 (1996). 95 id. (citing altria group, inc. v. good, 555 u.s. 70, 77 (2008)). 96 id. (citing altria group, inc. v. good, 555 u.s. 70, 77 (2008)). 97 id. at 2486. 98 id. at 2481 (breyer, j., dissenting) (citing smiley v. citibank (south dakota), 517 u.s. 735, 739-41 (1996)). http://dx.doi.org/10.2139/ssrn.2278341 786 indiana health law review vol. 12:2 applied to the fdca in the first of three fundamental cases, wyeth v. levine.99 iv. case law, indiana statutory dissemination, and recourse available for generic drug consumers this section will explore the three recently decide supreme cases relevant to the preemption inquiry. this section will then continue by exploring indiana law as it relates to this precedent and it will demonstrate how previously decided cases would likely result in unjust and inequitable decisions following the court’s precedent. finally, this section will explore alternative options available for generic drug consumers to protect themselves. a. wyeth, pliva and bartlett 1. wyeth – no state tort law preemption from fda’s brand-name drug regulations the first of the three supreme court cases involved a plaintiff that brought suit against a brand-name drug manufacturer on a failure-to-warn claim. 100 in wyeth v. levine, respondent diana levine suffered injuries from an iv-push injection of phenergan.101 as a result from such injuries, ms. levine was required to have her right hand and forearm amputated.102 ms. levine suffered substantial medical expenses and the loss of her livelihood as professional musician.103 in their decision, the jury found wyeth negligent and concluded that phenergan was a defective product that had inadequate warnings and instructions.104 specifically, the instructions had failed to “instruct clinicians to use the iv-drip method of intravenous 99 wyeth v. levine, 555 u.s. 555, 581 (2009). 100 id. at 560. 101 id. 102 id. at 559. 103 id. 104 id. at 562. 2015 787 the supreme court’s overreaching preemption interpretation and it’s consequences administration instead of the higher risk iv-push method” that was used on ms. levine.105 the drug manufacturer claimed impossibility preemption in the appeal.106 the manufacturer argued it was impossible to comply with the state-law duty to modify phenergan’s label because federal law prohibited the unilateral change of a drugs label.107 in dispensing with this argument, the court reasoned the manufacturer failed to demonstrate it was impossible to comply with both federal and state law.108 under the court’s analysis, the changes being effected (“cbe”) regulation allowed manufacturers to supplement and change their label. 109 this “permitted wyeth to unilaterally strengthen its warning, and the mere fact that the fda approved phenergan’s label [did] not establish that it would have prohibited such a change.”110 in the concurrence, justice breyer stated the court had “no occasion in this case to consider the pre-emptive effect of a specific agency regulation being the force of law.”111 he continued by reasoning that federal statutes and regulations neither protected the manufacturer from the risk of state-law liability nor prohibited the stronger warning label required by the state court’s judgment. 112 comparatively, in another concurrence, justice thomas concluded that with no “direct conflict” between the federal and state law, the state-law judgment was not preempted.113 the majority decision was consistent with the long-established presumption against finding 105 id. at 560. 106 id. 107 id. at 563-64. 108 id. at 573. 109 id. 110 id. 111 id. at 581 (breyer, j., concurring). 112 id. at 583. 113 id. at 593 (thomas, j., concurring) (citing am. tel. & tel. co. v. cent. off. tel., inc., 524 u.s. 214, 221-26 (1998) (finding preemption where federal law forbade common carriers from extending communications privileges requested by state-law claims)). 788 indiana health law review vol. 12:2 preemption. this presumption would be discarded less than two years later in a subsequent supreme court decision. 2. pliva – state tort law preemption for failure-towarn claims against generic manufacturers the court in pliva v. mensing went directly against the reasoning and holding in wyeth. in pliva v. mensing, the court expanded the scope of the impossibility preemption, which resulted in granting immunity to generic drug manufacturers in state-law failure-to-warn claims.114 two separate suits were consolidated into one lawsuit and the drug at issue was a generic equivalent, not the brand-name drug. 115 both plaintiffs had been prescribed metoclopramide a generic version of the drug reglan to treat their digestive tract problems. 116 after taking the generic drug for several years, both plaintiffs developed tardive dyskinesia, a disorder of involuntary bodily movements. 117 the plaintiffs argued the generic drug manufacturer was liable for failing to provide adequate warning labels, as required by state law.118 the plaintiffs also argued that the cbe process explicitly permitted manufacturers to change their labels when additional information is available.119 the cbe process permits drug manufacturers to “add or strengthen” its labels.120 the fda told the court that label strengthening by a generic drug manufacturer is permissible only if the generic drug manufacturer sought to change the label to match that of an updated brand-name drug. 121 the fda continued by arguing its interpretation was not determined to be “plainly erroneous or inconsistent with the regulation.”122 furthermore, the fda opined for 114 pliva, inc. v. mensing, 131 s.ct. 2572 (2011). 115 id. 116 id. at 2572-73. 117 id. at 2573. 118 id. 119 id. at 2575. 120 21 c.f.r. § 314.70(c)(6)(iii)(a) (2015). 121 pliva, inc., 131 s.ct. at 2575. 122 id. 2015 789 the supreme court’s overreaching preemption interpretation and it’s consequences the court to hold the manufacturer to the “duty of sameness” standard and to not permit the unilateral label change under the cbe process.123 the generic drug manufacturer argued that fda regulations and federal statute preempted state law tort claims because the federal “duty of sameness” required the same labeling for their generic drug metoclopramide124 as the non-generic drug reglan had.125 the court agreed and found that impossibility preemption was present because the state law required the generic manufacturer to change the drug label in a way to make it reasonably safe while the fda regulation explicitly prevented generic drug manufacturers from independently changing their generic drug safety labels.126 therefore, as pointed out in justice sotomayor’s dissent, the majority assumed that generic drug manufacturers “read the fda regulation to require them only to ensure that their labels match the brand-name labels.”127 under current law, a drug’s “labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.” 128 however, the court did not address the issue of whether the generic drug manufacturer had a duty to request a strengthened label from the fda; “[b]ecause [the court] ultimately [found] preemption even assuming such a duty [to request a strengthened label] existed, [the court did] not resolve the matter” of whether there was a duty on the generic drug manufacturer to request a strengthened label.129 thus, under the majorities’ flawed reasoning, “[h]ad [petitioners] taken reglan, the brand-name drug prescribed by their doctors, wyeth would control and their lawsuits would not be pre-empted. but 123 id. 124 id. at 2573. 125 id. at 2572. 126 id. at 2577-78. 127 id. at 2586 (sotomayor, j., dissenting). 128 21 c.f.r. § 201.57(c)(6)(i) (2015). 129 pliva, inc., 131 s.ct. at 2576, 2577. 790 indiana health law review vol. 12:2 because [they were prescribed with] metoclopramide instead, federal law preempts these lawsuits.”130 generic drug manufacturers should not be permitted to “sustain their burden of showing impossibility if they have not even attempted to employ that mechanism.” 131 a generic drug manufacturer should have the burden to propose label changes to the fda, and in the event such proposal is denied, then it would be possible for impossibility preemption to exist.132 as such, generic drug manufacturers should not be granted preemption protection without even attempting to propose change. as a result of the court’s decision in pliva, generic drug consumers have no legal recourse against generic drug manufacturers who fail to update their labels. consequently, generic drug manufacturers no longer will “monitor and disclose safety risks” they find as they will be able to rely solely on brandname manufacturer label changes or being immune through the preemption doctrine. 133 currently 90% of consumers opt for generic drug alternatives, and under this dangerous precedent, many consumers may not have modes of relief for injuries against generic drug manufacturers.134 it was not impossible for the generic drug manufacturer to comply with federal and state law in pliva. the manufacturer could have approached the fda and the agency may well have agreed that a change to the label was necessary.135 however, the court created a new law: “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law 130 id. at 2581. 131 id. at 2589 (sotomayor, j., dissenting). 132 id. at 2588. 133 unequal justice: pliva v. mensing, alliance for just., http://www.afj.org/multimedia/first-monday-films/unequal-justice-plivav-mensing (last visited mar. 20, 2015). 134 brian wolfman & anne king, mutual pharmaceutical co. v. bartlett and its implications, bureau of nat’l aff., http://about.bloomberglaw.com/practitioner-contributions/mutualpharmaceutical-co-v-bartlett-and-its-implications/ (last visited mar. 20, 2015). 135 pliva, inc., 131 s.ct. at 2587 (sotomayor, j., dissenting). 2015 791 the supreme court’s overreaching preemption interpretation and it’s consequences requires of it.” 136 this interpretation flew against the longstanding presumption against preemption such that courts required a “strong” showing of conflict “to overcome the presumption that state and local regulation can constitutionally coexist with federal regulation.”137 the pliva decision indirectly gives physicians the authority to tell patients that while it may be cheaper to use generic drugs, they may have no legal protections if the generic drug injures them. notably, “the dispensing of generic drugs on ‘brand-written’ prescriptions rather than generically written prescriptions [have] become the chief source of generic drug sales through pharmacies.” 138 furthermore, every state has a law governing generic drug substitution and fourteen states mandate generic substitution if “brand only” isn’t indicated by the prescribing physician.139 the danger of these substitution laws is that a patient may unknowingly be given a generic drug, which further exacerbates the likelihood of a consumer taking a drug in which they have no legal recourse against the manufacturer. 140 pharmacists also have financial incentives to dispense generics because it increases profit margins.141 balancing affordability with safety is an inequitable decision innocent consumers should not be faced with. in pliva, the majority did not show a “clear and manifest purpose of congress” because congress did not expressly preempt label changing.142 congress explicitly enacted an express preemption provision for medical devices in 1976 and it declined to do so for pharmaceuticals.143 it would 136 id. at 2579. 137 id. at 2591 (sotomayor, j., dissenting) (citing hillsborough cnty. v. automated medical laboratories, inc., 471 u.s. 707 (1985)). 138 steele, supra note 7 at 461. 139 expanding the use of generic drugs, u.s. dep’t of health & human servs., (dec. 1, 2010), http://aspe.hhs.gov/sp/reports/2010/genericdrugs/ib.pdf. 140 id. 141 steele, supra note 7 at 462. 142 wyeth v. levine, 555 u.s. 555, 565 (2009). 143 21 u.s.c. § 360k(a) (2015). 792 indiana health law review vol. 12:2 seem more likely than not that congress did not intend for prescription drugs to be governed by preemption provisions. the holding goes against the holding in wyeth and the commonly held notion to fdca and fda regulations that the manufacturer bears responsibility for the content of its label “at all times.”144 after all, the court itself agreed that holding a brand-name manufacturer and not a generic drug manufacturer liable “makes little sense.”145 3. bartlett state tort law preemption for design defect claims against generic manufacturers two years following the pliva decision the court unnecessarily expanded the already overreaching application of the preemption doctrine. 146 in mutual pharmaceutical co. v. bartlett karen bartlett, the plaintiff, was prescribed sulindac a generic version of the drug clinoril for her shoulder pain.147 as a result of taking sulindac, ms. bartlett developed toxic epidermal necrolysis a skin condition that causes ones skin to peel in sheets leaving large areas of her skin exposed. 148 when ms. bartlett was prescribed sulindac the drug did not warn of the risk of developing toxic epidermal necrolysis.149 soon 144 wyeth, 555 u.s. at 571. 145 pliva, inc. v. mensing, 131 s.ct. 2581 (2011). 146 mut. pharm. co., inc. v. bartlett, 133 s.ct 2466 (2013). 147 id. at 2472. sulindac is a “non-steroidal, anti-inflammatory indene derivative designated chemically . . . .” clinoril gained fda approval in 1978 and clinical trials at that time revealed negative side effects as “relatively mild.” see clinoril, rxlist, http://www.rxlist.com/clinoril-drug.htm (last visited mar. 21, 2015). see also brief for respondent, mut. pharm. co., inc. v. bartlett, 133 s.ct 2466 (2013) (no. 12-142), 2013 wl 602909, at *5 (noting that mutual pharmaceutical’s anda was approved in 1991). 148 mut. pharm. co., 133 s.ct. at 2472. see also toxic epidermal necrolysis, johns hopkins med., http://www.hopkinsmedicine.org/ healthlibrary/conditions/dermatology/toxic_epidermal_necrolysis_85,p0 0321/ (last visited mar. 21, 2015) (noting that the disease progresses fast and treatment involves hospitalization in a burn unit and includes antibiotics, protective bandages, and intravenous immunoglobulin g (used to prevent further immune system damage)). 149 mut. pharm. co., 133 s.ct. at 2472. 2015 793 the supreme court’s overreaching preemption interpretation and it’s consequences after ms. bartlett filed suit in new hampshire state court, the case was removed to federal court and a jury found mutual pharmaceutical liable under a design-defect claim.150 the first circuit affirmed the decision of the jury, finding no preemption.151 however, mutual pharmaceutical appealed the decision and the supreme court held designdefect claims turning on the adequacy of a drugs warning are preempted.152 new hampshire courts employ a “risk-utility approach” in the design-defect analysis.153 new hampshire courts ask whether “magnitude of the danger outweighs the utility of the product.”154 generally, new hampshire courts consider three main factors, although such are non-exhaustive, which include: “[1] the usefulness and desirability of the product to the public as a whole, [2] whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and [3] the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.” 155 the supreme court reasoned in their decision that increasing sulindac’s “usefulness” or reducing its “risk of danger” was not possible because the fdca explicitly requires generic drugs to have the same active ingredients 156 and because the simple composition of sulindac prevented it from being redesigned.157 the court further reasoned that strengthening sulindac’s warning label was mutual pharmaceutical’s only way to minimize its “risk-utility” profile. 158 therefore, because mutual pharmaceutical was not permitted to strengthen their label, 150 id. 151 id. 152 id. at 2473. 153 id. at 2474. 154 id. 155 id. at 2475. 156 21 u.s.c. §§ 355(j)(2)(a)(ii)-(iii) (2015). 157 mut. pharm. co., 133 s.ct. at 2475. 158 id. 794 indiana health law review vol. 12:2 the court concluded that federal law as discussed under pliva prevented a unilateral change to sulindac’s label.159 the court’s holding presupposes that drug manufacturers have a right to continue to sell drugs free of liability once approval has been given. 160 however, rejecting impossibility preemption here would not render preemption a “dead letter” 161 because mutual pharmaceutical was not legally obligated by new hampshire’s design-defect law to modify its label in a way that federal law prohibits. 162 under applicable new hampshire law, an unreasonably dangerous drug manufacturer has several options: “it can change the drug’s design or label . . . to alter its risk-benefit profile, remove the drug from the market, or pay compensation as a cost of doing business.”163 therefore, new hampshire law allowed this manufacturer to either remove sulindac from the market or pay compensation to the injured party as a result of the injury.164 new hampshire’s design-defect law did not explicitly require mutual to change the label for sulindac and it did not mandate a change to sulindac’s design. 165 rather, under new hampshire law, the warning label is one factor in a non-exhaustive list.166 the applicable new hampshire law required nothing more than compensating an individual who was determined by a jury to have been injured by an “unreasonably dangerous drug.” 167 as the district court made clear, mutual was held liable for failing to adequately label sulindac so that it was not “unreasonably dangerous,” not for “failing to change” its warning.168 new hampshire sought to facilitate federal statutes by providing legal protection to its residents. providing such legal protection 159 id. at 2476-77. 160 id. at 2491-92 (sotomayor, j., dissenting). 161 id. at 2492. 162 id. 163 id. at 2491. 164 id. 165 id. at 2487 (sotomayor, j., dissenting). 166 see id. at 2475. 167 id. at 2489 (sotomayor, j., dissenting). 168 id. at 2490. 2015 795 the supreme court’s overreaching preemption interpretation and it’s consequences is “a choice that a sovereign state may [and often does] impose to protect its citizens from dangerous drugs or . . . ensure that seriously injured consumers receive compensation.”169 manufacturers should have a duty to monitor the safety and efficacy of their products by being required to approach the fda to propose label changes when necessary. it has remained central to fdca and fda regulations that a drug manufacturer bears the responsibility for the content of its label “at all times.” 170 additionally, if congress thought that state-law causes of action (such as new hampshire’s discussed in bartlett) posed an obstacle to statutory objectives, it surely would have enacted express preemption provisions at some point during the fdca’s seventy-year history. congress had the opportunity to explicitly apply the preemption doctrine to pharmaceuticals, yet it declined to do so and only applied it to medical devices.171 congress has never explicitly preempted state law tort claims against drug manufacturers. 172 while it is possible the court’s “statement that tort remedies and direct regulation do ‘the same thing’ may fade away when the court again is presented with the issue and has the opportunity to treat it with more care[,] ”173 irreparable harm will likely occur if this issue is not addressed sooner. b. indiana’s statutory analysis and the importance of state law state tort law causes-of-action provide remedies to individuals harmed by the negligent acts of others. tort laws play an important role in filling gaps in federal law and in discovering risks and “in providing incentives for manufacturers to remove dangerous products from the market promptly.” 174 in holding a particular state law 169 id. at 2491. 170 wyeth v. levine, 555 u.s. 555, 570-71 (2009). 171 see riegel v. medtronic, inc., 552 u.s. 312, 340 (2008). 172 pliva, inc. v. mensing, 131 s.ct. 2577 (2011). 173 wolfman & king, supra note 134. 174 jocelyn bogdan, america’s unaccountable generic drug 796 indiana health law review vol. 12:2 preempted by federal law, injured consumers often have to rely on imperfect federal agencies with limited resources for relief. 175 because detrimental effects may occur when federal law preempts state law, congress takes affirmative steps when it believes tort law may compromise significant federal objectives under a scheme of premarket regulatory review for products it wants to make available.176 federal agencies themselves consider tort litigation supplementary to its agencies regulations and enforcement activities.177 indiana law is similar to new hampshire law in that it provides residents with state law causes-of-action.178 under design-defect law in indiana, a product may be defective through manufacturing flaws, defective design, or by a failure to supply complete information about the product’s dangers.179 to establish a prima facie case of strict liability in indiana, the plaintiff has the burden of proving each of the following: “(1) the product is defective and unreasonably dangerous, (2) the defective condition existed at the time the product left defendant’s control, and (3) the defective condition was the proximate cause of the plaintiff’s injuries.”180 a product liability action based on the doctrine of strict liability may not be maintained against a seller industry: how legal immunity could be making you sick, center for justice democracy (dec. 2013), http://centerjd.org/content/americasunaccountable-generic-drug-industry. 175 leslie pray & sally robinson, challenges for the fda: the future of drug safety (2007), available at http://www.ncbi.nlm.nih.gov/books/nbk52926/ (according to mr. thompson, the fda has been chronically under-funded in carrying out its responsibilities for ensuring the safety of drugs, medical devices, and the nation’s food supply. while the fda is commonly viewed as the global gold standard for consumer protection, it faces stiff competition for scarce resources and over the past 20 years has been tasked to do far more with its limited resources). 176 mut. pharm. co., inc. v. bartlett, 133 s.ct. 2466, 2496 (2013) (sotomayor, j., dissenting). 177 id. at 2485. see also bates v. dow agrosciences llc, 544 u.s. 431, 451 (2005). 178 see natural gas odorizing, inc. v. downs, 685 n.e.2d 155 (ind. ct. app. 1997). 179 see ind. code § 34-20 et seq. (2015). 180 natural gas odorizing, inc., 685 n.e.2d at 160. 2015 797 the supreme court’s overreaching preemption interpretation and it’s consequences unless the seller is a “manufacturer of the product or of the part of the product alleged to be defective.”181 whether a product is in an unreasonably dangerous and defective condition is a question of fact.182 indiana requires that the plaintiff show that a product is in a “defective condition” and also that it is “unreasonably dangerous.”183 an objective inquiry is required to determine whether a product is defective or unreasonably dangerous. this inquiry focuses on the product and its manufacturer or seller assessed by an objective standard regarding expected use.184 the “unreasonably dangerous” requirement “refers to any situation in which the use of a product exposes the user or consumer to a risk of physical harm to an extent beyond that contemplated by the ordinary consumer who purchases the product with the ordinary knowledge about the product’s characteristics common to the community of consumers.”185 even if the seller (manufacturer) has exercised all reasonable care in the preparation and manufacturing of a product, a person selling, leasing, or otherwise putting a defective or unreasonably dangerous product in the stream of commerce is subject to liability. 186 however actions claiming design-defect require that the “party making the claim must establish that the manufacturer or seller failed to exercise reasonable care under the circumstances in designing the product or in providing the warnings or instructions.” 187 for example, in indiana ms. bartlett would have had to establish that mutual pharmaceutical failed to exercise reasonable care in providing warnings for their drug sulindac. 181 ind. code § 34-20-2-3 (2015). 182 corbin v. coleco indus., inc., 748 f.2d 411, 419 (7th cir. 1984). 183 bourne v. marty gilman, inc., 452 f.3d 632, 635-36 (7th cir. 2006) (citing mcmahon v. bunn-o-matic corp., 150 f.3d 651, 657 (7th cir. 1998)). see also baker v. heye america, 799 n.e.2d 1135, 1140 (ind. ct. app. 2003)). 184 moss v. crosman corp., 945 f.supp. 1167, 1181 (n.d. ind. 1996). 185 ind. code § 34-6-2-146 (2015). 186 ind. code § 34-20-2-2 (2015). 187 id. 798 indiana health law review vol. 12:2 under indiana law a product is not presumed unreasonably dangerous if it injures a person in a way known to the community of persons consuming the product.188 this is likely not applicable in pharmaceutical cases because one is unlikely to take a drug if the community of consumers knows of its dangers. the relative obviousness of a defect is relevant in considering whether or not a product is defective and unreasonably dangerous.189 the relative obviousness of a defect is unlikely to effect suit against a pharmaceutical manufacturer because consumers will not take drugs that have an obvious defect. furthermore, obvious defective drugs would not be permitted for sale in the market. finally, manufacturers are legally bound to design and build products that are reasonably fit and safe for their intended purpose.190 had bartlett been decided years ago, many past decisions would likely have had different outcomes. examining the effects of this precedent on previous decisions helps reveal the danger of this precedent to future cases. in bell v. lollar, the indiana court of appeals reasoned that a state-law claim against a generic drug manufacturer in a failure-to-warn claim was not preempted because the manufacturer was free to strengthen its label.191 the plaintiff, lollar, alleged the label was in a “defective and unreasonably dangerous condition” because the label failed to warn him of the “risk associated with combining acetaminophen and alcohol.” 192 the court agreed, holding that the manufacturer “was free to strengthen its label by adding an alcohol warning” and the 188 moss, 945 f.supp. at 1176. 189 johnson v. kempler indus., inc., 677 n.e.2d 531, 538 (ind. ct. app. 1997). 190 liberty mut. ins. co. v. rich ladder co., inc., 441 n.e.2d 996, 999 (ind. ct. app. 1982). 191 bell v. lollar, 791 n.e.2d 849, 850 (ind. ct. app. 2003). 192 id. at 851. see also acetaminophen, drugs.com, www.drugs.com/acetaminophen.html (last visited mar. 21, 2015) (acetaminophen is a drug used to reduce fever and relieve pain that is used to treat many conditions, including “headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.” it is a common drug and there are many brands and forms available in the marketplace). 2015 799 the supreme court’s overreaching preemption interpretation and it’s consequences plaintiff’s “state law claim for failure to warn [was] not implicitly preempted by the fdca.”193 if the court in lollar had used bartlett as precedent, it is likely mr. lollar would not have had a cause of action to supplant his “alcoholic hepatitis, alcoholic dependency continuous, alcoholic gastritis with hemorrhage, and acute renal failure” 194 the decision would be different under bartlett because a generic drug manufacturer is not able to unilaterally change the drugs label, other than to match the label of a brand-name drug as required under the duty-ofsameness. like new hampshire, indiana as a sovereign state chose to create certain causes-of-action to protect its citizens rights. the underlying purpose of indiana’s (and new hampshire’s) causes-of-action is not to force companies to change their labels, but to compensate the injured and to punish the negligent. this rationale was pointed out by the dissent in mutual which stated that the manufacturer was held liable for breaching the duty to adequately label sulindac so that it was not “unreasonably dangerous,” not for “failing to change” its warning.195 in the similarly decided indiana case, tucker v. smithkline beecham corp., the plaintiff brought a wrongful death claim under indiana law against the defendant drug manufacturer, claiming that her brother committed suicide as a result of taking the manufacturer’s antidepressant and that the drug manufacturer breached its duty to warn.196 the court held that there was no preemption by reasoning that the manufacturer had a duty to strengthen its label and that “if the fda exercise[d] its power to disapprove the revised label, the fda’s disapproval is not retroactively illegal; the manufacturer [can] simply stop[] distributing the new label.”197 thus, under the court’s holding, the deceased 193 bell, 791 n.e.2d at 855. 194 id. at 850. 195 mut. pharm. co., inc. v. bartlett, 133 s.ct 2466, 2490 (2013) (sotomayor, j., dissenting). 196 tucker v. smithkline beecham corp., 596 f.supp.2d 1225, 1227 (s.d. ind. 2008). 197 id. at 1229 (citing 21 c.f.r. § 314.70(c); witczak v. pfizer, inc., 377 f.supp.2d 726, 729 (d. minn. 2005)). 800 indiana health law review vol. 12:2 beneficiary/next-of-kin would have a cause-of-action because the manufacturer failed in its duty to provide a label that is not “unreasonably dangerous.” the tucker decision likely would have been decided differently if the court had relied upon bartlett as precedent. if the tucker court relied on bartlett, the court likely would have concluded that the preemption doctrine would apply because it would be impossible for the drug manufacturer to comply with the state law of strengthening the drug’s label so as to not make it unreasonably dangerous and with the federal law requiring the same label as the brand-name counterpart. an inequitable decision would have resulted, as a negligent drug manufacturer would have left the injured party’s beneficiary/next-of-kin without legal recourse to address the manufacturer’s negligence. following the decisions in pliva and bartlett, as many as 6,596,855 indiana residents may be left without legal recourse to address generic drug manufacturer breaches.198 these two decisions are in essence providing legal immunity to generic drug manufacturers. approximately 80% of all drugs purchased are generic. therefore, as many as 3,694,239 indiana residents may be left without the right to sue generic drug manufacturers.199 it remains important to address this large legal gap. c. recourse available to generic drug consumers today, seven in ten americans take prescription drugs to treat various health issues.200 a significant portion of these 198 indiana, u.s. census bureau, available at http://quickfacts.census.gov/qfd/states/18000.html (last visited mar. 30, 2015). 199 id. see also footnote 1. because approximately 7 in 10 americans have taken prescription drugs, an estimated 4,617,798 indiana residents have taken prescription drugs. because 80% of drugs taken are generic, an estimated 3,694,239 indiana residents have taken generic prescription drugs (6,596,855 residents divided by 70% (the percentage of individuals taking prescription drugs) divided by 80% (the estimated number of individuals that take generic drugs)). 200 nearly 7 in 10 americans, supra note 4. 2015 801 the supreme court’s overreaching preemption interpretation and it’s consequences individuals who opt to take generics will have no access to compensation if injured as a result of a drug manufacturer’s design-defect or failure-to-warn. many consumers are not aware of this legal loophole and those that are face a very difficult situation: should they purchase the more expensive brand-name drugs that provide legal protection or should they purchase the more affordable generic equivalent without such protection? this assumes consumers have the ability to purchase more expensive brand-name drugs, when in fact many are unable to do so. furthermore, many prescriptions are unknowingly filled by generic equivalents at pharmacies. legal scholars have discussed creative arguments to avoid this preemption barrier. one strategy to avoid being preempted is to file a “failure to update” claim accusing generic manufacturers of not changing labels quickly enough after the brand-name equivalent updated their label.201 this claim would only be plausible if the brandname manufacturer had already discovered this issue and had changed the drugs label. assuming the brand-name drug manufacturer has not discovered the issue, four potential course of action remain. first, one could sue the brand-name manufacturer alleging they bear responsibility for the generic drug’s shortcomings. second, one could sue the generic drug manufacturer under the fdca’s misbranding statute. third, one could opt to purchase brand-name drugs and not their generic counterparts. the final and most complete solution would be to petition congress and the fda to take action to correct this dangerous precedent. 1. option one suing the name brand manufacturer the first option available to consumers injured by generic drugs would be to sue the brand-name equivalent manufacturer. under this cause of action that is often 201 lorelei laird, generic drugs leave a bad taste for patients filing tort suits, aba j. (feb. 1, 2014, 9:20 am), http://www.abajournal.com/mobile/mag_article/generic_drugs_leave_a_b ad_taste_for_patients_filing_tort_suits. 802 indiana health law review vol. 12:2 referred to as “innovator liability,” injured drug consumers could file suit against brand-name manufacturers claiming that they bear sole responsibility for a generic manufacturer’s label.202 as it currently stands, “pliva and mutual may provide complete (or at least substantial) immunity to generic manufacturers, but their reasoning that generic drug labels are the province of brand-name manufacturers is consistent with a state-law duty that makes brand-name manufacturers responsible.” 203 thus, these brand-name suits would be based on claims of “negligent and/or intentional misrepresentation, which plaintiffs [could argue] . . . authorizes liability against a non-seller who has reason to know that a third party could suffer harm.” 204 many states, including indiana, do recognize liability for negligent misrepresentation. 205 however, no indiana precedent has been established on this issue and many states have held that brand-name suits are 202 see fullington v. pfizer, inc., 720 f.3d 739, 747-48 (8th cir. 2013) (murphy, j., concurring) (explaining in dicta that pliva and bartlett “severely eroded the foundation of th[e] analysis” of the courts that have rejected brand-name suits because that analysis has “generally been predicated on the assumption that the generic manufacturers could independently safeguard and strengthen their own labels”). 203 wolfman & king, supra note 134. 204 id. (citing conte v. wyeth, inc., 85 cal. rptr. 3d 299, 309-10 (cal. ct. app. 2008) (explaining differences in strict products liability and misrepresentation theories in case brought by generic drug user who sued brand-name manufacturer on misrepresentation theory)). see also restatement (second) of torts § 311 (1965) (“one who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information, where such harm results . . . to such third persons as the actor should expect to be put in peril by the action taken.”). 205 see passmore v. multi-mgmt. servs., inc., 810 n.e.2d 1022, 1025 (ind. 2004). see also kimball parker, a historical approach to negligent misrepresentation and federal rule of civil procedure 9(b), 80 u. chi. l. rev. 1461 (2013) (discussing different circuits interpretations and treatments of negligent misrepresentation claims). 2015 803 the supreme court’s overreaching preemption interpretation and it’s consequences not viable under state law due to their stretched foreseeability concept.206 the alabama supreme court established precedent on the above theory in wyeth, inc. v. weeks by holding that their law permits brand-name drug manufacturers to be held liable for misrepresentations, even if a generic equivalent drug was taken. 207 the court addressed the unfairness argument by stating that “alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated . . . by the generic manufacturer.” 208 the court reasoned that the special sameness requirement gave them the ability to consider the innovator liability argument. 209 the court cited to the unique relationship between the brand-name and generic drugs.210 the alabama supreme court reheard the case in september 2013.211 after rehearing, the alabama supreme court affirmed their previous ruling in a 6-3 decision. many argued against this decision claiming it is “a basic of products liability, it’s in the restatement of torts … that a manufacturer is responsible [only] for the products it makes . . . .”212 unfortunately, there are several cases in their favor; as of january 2014, “77 cases [said] name-brand manufacturers don’t owe any duty to people who never took their products [and] [s]ix federal appeals courts have ruled that way.”213 the supreme court of iowa recently rejected this innovator liability theory in the decision huck v. wyeth.214 206 see foster v. am. home prods. corp., 29 f.3d 165 (4th cir. 1994); baymiller v. ranbaxy pharm., inc., 894 f.supp.2d 1302 (d. nev. 2012) (holding that consumer’s use of generic pharmaceutical precluded claims of strict products liability against brand-name manufacturer). 207 wyeth, inc. v. weeks, 1101397, 2014 wl 4055813 (ala. aug. 15, 2014). 208 id. at *23. 209 id. 210 id. 211 id. 212 laird, supra note 201. 213 id. 214 huck v. wyeth, inc., 850 n.w.2d 353 (iowa 2014). 804 indiana health law review vol. 12:2 an innovator liability cause of action would be based on negligent and/or intentional misrepresentation and not on strict product liability. the negligent and/or intentional misrepresentation suit would “authorize[] liability against a non-seller who has reason to know that a third party could suffer harm.”215 thus, the injured party could allege that even if a generic equivalent drug was taken, the brandname manufacturer’s label error was a foreseeable cause of his/her injuries because the generic drug manufacturer should reasonably know that “whenever one of its products is mislabeled, the generic product will be as well.”216 most courts have dismissed these types of “innovator liability claims” by reasoning that plaintiffs should not be able to sue drug manufacturers that did not make the drug they consumed.217 2. option two – suing the generic drug manufacturer for misbranding an individual injured from a generic drug could bring suit against the generic drug manufacturer under the fdca’s misbranding statute.218 this misbranding statute provides that a drug is misbranded if, amongst other things, “[i]t is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling . . . .” 219 mutual’s majority reasoned that “[f]ederal law itself bars the sale of previously approved drugs if new information comes to light demonstrating that the drug is ‘dangerous to health’ and thus ‘misbranded.’”220 however, following the pliva decision, a misbrand-based claim would probably 215 wolfman & king, supra note 134. 216 id. 217 lorelei, supra note 201. 218 see 21 u.s.c. § 352 (2015). 219 labeling requirements – misbranding, u.s. food & drug admin., http://www.fda.gov/medicaldevices/ deviceregulationandguidance/overview/devicelabeling/generaldevice labelingrequirements/ucm052190.htm (last updated mar. 11, 2015). 220 mut. pharm. co., inc. v. bartlett 133 s.ct. 2466, 2492 (2013) (citing 21 u.s.c. §§ 331(a), 352(j) (2015)). 2015 805 the supreme court’s overreaching preemption interpretation and it’s consequences need to be brought as a design-defect claim. although unlikely to succeed, this type of lawsuit does remain available. 3. option three – paying for protection through brand name drugs individuals seeking to avoid injury without recourse may purchase brand-name drugs as opposed to their generic equivalents. the cost difference is often substantial and consumers will have to decide if the average $100 price difference is worth the risk. 221 having this option as a solution is not sufficient to protect the estimate 1,015,916 indiana residents living under the poverty rate. 222 furthermore, some health insurance providers will not pay for brand-name drugs if a generic equivalent is available.223 therefore, this option would only help certain individuals that know of this legal issue and are able and willing to purchase brand-name drugs. 221 see generic versus brand medications, healthsmart, http://www.healthsmart.com/smarterhealth/genericvsbranddrugs.asp x (last visited mar. 21, 2015) (noting that in 2008 the average price of a brand-name drug was $137.90, while their generic counterparts were only $35.22). 222 indiana, u.s. census bureau, available at http://quickfacts.census.gov/qfd/states/18000.html (last visited mar. 30, 2015) (6,596,855 x .154 persons below the poverty level from 2009-2013 averaged 15.4%. for purposes of this example i have assumed the poverty level would remain 15.4% in 2014)). 223 see michael bihari, understanding your health plan, about.com http://healthinsurance.about.com/od/prescriptiondrugs/a/understanding _formulary.htm (last visited mar. 21, 2015) (drugs are often grouped into tiers and “[t]ier 1 has the lowest co-payment and usually includes generic medications.” “tier 2 has a higher co-payment than tier 1 and usually includes preferred brand-name medications.” finally, “[t]ier 3 has the highest co-payment and usually includes non-preferred brandname medications.”). 806 indiana health law review vol. 12:2 4. option four legislative amendment attorneys are capable of crafting creative arguments and some consumers are capable of purchasing brand-name drugs as opposed to their generic equivalents. however, both of these options fail to address the issue at hand which is the dangerous legal precedent established by the court. the only complete solution to this legal dilemma is to amend the labeling requirements and duties of all drug manufacturers. furthermore, congress could solve the issue of preemption by explicitly saying preemption is not present and that a state law provides recourse to individuals injured by generic drugs. one could argue that the fda may have authority to solve such an issue, but to avoid future lapse of legal recourse 224 it would best to statutorily amend the law. by amending the hatch-waxman act, congress could hold generic manufacturers liable for failing-to-warn or failing-to-update their labels, which would invariably allow injured consumers legal recourse. currently, unilateral changes by generic drug manufacturers are not permitted because generic drug manufacturers must abide to a duty of sameness.225 modifying the appropriate provision to allow and even require generic drug manufacturers to update their labels would properly shift the burden onto the manufacturer and it would permit consumers legal recourse if these manufacturers failed in this duty. another possible solution available to congress would be to “provide that generic drug manufacturers . . . are authorized to use the cbe process.” 226 currently, cbe 224 see wyeth v. levine, 555 u.s. 555, 567 (2009) (the fda may not have the authority to modify the “sameness” requirement to allow generic drug manufacturers to be liable for design-defect claims. indeed, prior to 2007, the fda lacked the authority to order manufacturers to revise their label and only when congress granted the fda this authority did the agency have the ability to modify the rule); louisiana pub. serv. com’n v. f.c.c., 476 u.s. 355, 374 (1986) (“[a] federal agency may pre-empt state law only when and if it is acting within the scope of its congressionally delegated authority.”). 225 see generally 21 c.f.r. § 314.150 (2015). 226 wolfman & king, supra note 134. 2015 807 the supreme court’s overreaching preemption interpretation and it’s consequences rules allowing non-generic drug manufacturers to unilaterally change and strengthen their labels are unavailable to anda holders. because generic drugs have taken the majority of the pharmaceutical market share, these manufacturers are in a better position to collect and report data. this amendment would be especially important for the one-third market-share that has no brand-name counterpart on the market at all. 227 by modifying the cbe statute, generic drug manufacturers would be required to unilaterally strengthen their warnings without having to comply with the sameness requirements. legislation was previously introduced into the senate and house of representatives in 2012 to give anda holders the ability to change labeling but the bill never reached the floor.228 following the bartlett decision and public outcry, the fda acknowledged it “is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances,” adding that “if such a regulatory change is adopted, it could eliminate failure-to-warn preemption claims against generic-drug manufacturers.”229 the fda has announced that they are working on label requirement modification requirements; the fda’s notice of proposed rulemaking entitled “’supplemental applications proposing labeling changes for approved drugs and biological products” has been identified as seeking to “revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in 227 transcript of oral argument at 41, pliva, inc. v. mensing, 131 s.ct. 2567 (2011) (no. 09-993), available at http://www.supremecourt.gov/oral_arguments/argument_transcripts/09993.pdf. 228 see patient safety and generic labeling improvement act, s. 2295, 112th cong. (2012); patient safety and drug labeling improvement act, h.r. 4384, 112th cong. (2012). 229 wolfman & king, supra note 134. 808 indiana health law review vol. 12:2 advance of fda’s review of the change.”230 according to the fda, this proposed provision would create “parity” between nda and anda holders with respect to cbe’s.231 again, while it would likely face opposition232 the ultimate goal of the fda should be to foster public safety. such an amendment would help achieve this goal. the fda has acknowledged difficulty in handling the growing pharmaceutical industry. it is likely this issue will continue to worsen as the medical industry becomes more complex and as drug sales continue to grow. tort laws play an important role in supplementing the fda because the fda neither provide remedies nor compensates victims for their injuries. furthermore, tort laws play a crucial role in ensuring safety compliance within the pharmaceutical industry. while reducing tort liability for generic manufacturers may eventually result in more affordable 230 leslie kux, supplemental applications proposing labeling changes for approved drugs and biological products, fed. reg. (nov. 5, 2013), https://www.federalregister.gov/articles/2013/11/13/201326799/supplemental-applications-proposing-labeling-changes-forapproved-drugs-and-biological-products. 231 id. 232 see rich samp, can fda lawfully overrule scotus generic drug preemption decision through regulation?, forbes (aug. 2, 2013, 10:17 am), http://www.forbes.com/sites/wlf/2013/08/02/can-fda-lawfullyoverrule-scotus-generic-drug-preemption-decision-through-regulation/2/ (opponents could argue that it makes little sense to hold generic drug manufacturers, who are by definition relying on others’ safety data in marking their products, to make unilateral determinations that the fda’s judgments regarding proper labeling should be overridden. it is also likely that generic drug manufacturers will seek to influence such a law, as its passing would likely hold them more accountable and likely to be sued.). see also wyeth v. levine, 555 u.s. 555, 582 (2009) (breyer, j., concurring) (“i also note that some have argued that state tort law can sometimes raise prices to the point where those who are sick are unable to obtain the drugs they need.”)); travis sales et al., fda and potential new rules for labeling of generic drugs, pharmaceutical compliance monitor (october 7, 2013), http://www.pharmacompliancemonitor.com/fda-and-potential-new-rulesfor-labeling-of-generic-drugs/5664/#_edn2 (opponents may argue that the sameness requirement is important to “minimize any confusion among healthcare professionals and consumers as well as to preclude a basis for lack of confidence in the equivalency of generic versus brandname products”). 2015 809 the supreme court’s overreaching preemption interpretation and it’s consequences drugs, the consequences of legal immunity and public safety outweigh this position. as summarized by the court in wyeth, “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”233 v. conclusion congress should, and indeed must act to protect its constituents from the legal loophole resulting from the court’s two recent decisions in pliva and bartlett. consumers should not face the decision of choosing between legal protection and essential living supplies. attorneys are able to craft creative legal arguments, but at the expense of clients and their own peril. the only true solution to the loophole is legislative reform. without such action, generic drug manufacturers will remain free from liability and many injured generic-drug consumers will remain without any legal remedies. 233 wyeth v. levine, 555 u.s. 555, 579 (2009). i. introduction a. issue b. roadmap ii. the law and regulatory rules of the pharmaceutical industry a. historical background 1. patent law 2. the federal food and drugs act, the food drug and cosmetics act, and hatch-waxman act b. current regulatory laws affecting pharmaceutical drugs iii. preemption doctrine analysis a. preemption doctrine iv. case law, indiana statutory dissemination, and recourse available for generic drug consumers a. wyeth, pliva and bartlett 1. wyeth – no state tort law preemption from fda’s brand-name drug regulations 2. pliva – state tort law preemption for failure-to-warn claims against generic manufacturers 3. bartlett state tort law preemption for design defect claims against generic manufacturers b. indiana’s statutory analysis and the importance of state law c. recourse available to generic drug consumers 1. option one suing the name brand manufacturer 2. option two – suing the generic drug manufacturer for misbranding 3. option three – paying for protection through brand name drugs 4. option four legislative amendment v. conclusion what to do when you can't hear the whistleblowing: a proposal to protect the public's health by providing whistleblower protection for medical researchers jennifer s. bard· i. introduction .......................................................................................... 2 ii. the scope of the problem: dangers to the public from medical research and prescription drugs ......................................... 7 a. dangers of medical research for human subjects .................... 7 b. the importance of improved prescription drug regulations due to increasing use in us. culture ........................................... 11 c. why regulations are necessary for human subject research in the united states ......................................................... 13 iii. how drug development occurs in the united states ............. 15 a. the fda's role ofgoalkeeper ................................................. 15 b. the fda 's rule making authority .......................................... . 17 c. existing fda protections insufficient to protect research subjects ........................................................................................... is d. fda authority to regulate clinical trials ............................... 19 e. how fda oversees clinical trials .......................................... 21 f. dangers arise in all the four phases of fda regulation ........ 22 1. phase one and two: non-therapeutic research ................ 22 2. phase three and four: therapeutic research ..................... 23 3. the particular dangers in stages three and four: dangers from the therapeutic misconception ........................... 26 n. movement of clinical trials overseas ...................................... 30 a. the relationship between big pharma and academic *visiting professor, drake university law school; alvin r. allison professor of law, tex­ as tech university school of law and director, health law program; associate professor (adjunct) texas tech university school of medicine, department of psychiatry. this article was three years in the writing and benefitted from the assistance of many highly skilled and talented people. i thank kathryn kennon, cassie dallas, brett gardner, and texas tech law school research librarian sharon blackburn for their excellent research assistance. also, michele tbaetig, for her computer skills, and kristi ward, brie sherwin, and craig klugman for their extremely helpful comments. research about overseas participants in clinical trials was sponsored through the law, policy, and ethics core (lpec), western regional center of excellence (wrce) for biodefense and emerging infectious diseases research funded by: public health services, department of health and human services, and i particularly thank victoria sutton for including me in this project and for all her help and assistance. this article is dedicated to the memory of professor angela roddy holder who first introduced me to the compelling legal and ethical issues faced by participants in human subject research. from 1997 to 2001 i was a member of the whistleblower unit at the con­ necticut attorney general's office. the views expressed in this article are completely my own and do not reflect those of the connecticut attorney general's office. 2 indiana health law review [vol. 9:1 medical centers ............................................................................. 33 1. evidence of academic medicine's financial entanglement with big pharma: ghost writing and secret payments to medical academics .................................................................... 3 7 b. post-market protection: dangers to consumers after a drug is approved ........................................................................... 39 1. post-market reporting .......................................................... 40 2. features of current system which increase post-approval damages: how pharmaceutical company's practice of ghost writing affects the sale and marketing qf drugs after approval ............................................................................ 43 3. off-label prescribing ........................................................... 45 4. direct-to-consumer advertising ........................................... 46 v. why is it so difficult to get inside information: whistleblower protection for medical r.esearchers ................... 48 a. brief overview of whistle blowing: unknown risks and permanent harm of whistleblowing ........ ...................................... 48 b. whistle blowers' historical role in science and medicine ....... 51 c. researchers in drug research are also bound by confidentiality agreements, which impose penalties for violation of the company's trade secrets ..................................... 52 vi. why existing whistleblower protection laws don't work 54 a. lack of constitutional protection ............................................. 56 1. medical researchers are not protected by the first amendment? ............................................................................... 56 a. federal whistleblower law provides little protection for federal employees and none for private employees ......... 59 b. characterizing hiding information about a drug as a false claim against the government ....................................... 61 b. neither qui tam statutes nor bounty programs are not a substitute for whistleblower protection ......................................... 61 1. qui tam actions ........................................................ , .......... 62 2. federal whistleblower laws ................................................ 64 c. state whistleblower laws do not protect most medical researchers ....... _ ............................................................................. 65 vii. conclusions ..................................................................................... 66 i. introduction both the safety of human subjects participating in medical research1 i. the national institutes of health ("nlh") defines "clinical research" as "research that either directly involves a particular person or group of people or uses materials from 2012] whistleblower protection for medical researchers 3 and the consumers of the research's products2 are of vital importance to the public's health. unfortunately, most prescription drugs are developed be­ hind closed doors by private manufactwing companies. before a drug can be sold in the united states, the food and drug administration (fda) has the authority pursuant to the provisions of the food and drug administra­ tion amendments act of 2007 (fda,".) to ensure all drugs sold in the unit. ed states are both safe and effective.3 once approved by the fda, however, it is these same private compa­ nies which are responsible for monitoring reports of emerging harm once the drug is on the market. this structure of private development and private post-market oversight means that the only people with access to new infor­ mation are those who work inside the company itself.4 while some risks humans. such as their behavior or samples of their tissue, that can be linked to a particular living person" and further explains that "clinical research is medical research involving people." clinical research & clinical trials, nat'l ins'itiutes of health, http://www.nichd.nih.gov/healtb/clinicalresearcbl (last updated july 23, 2009); patient re­ cruitment at the nih clinical center, nat'l insti1utes of health, http://www.cc.nih.gov/ recruit/ (last updated nov. 22, 2010). for purposes of this paper, i adopt the federal defini­ tion of research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 45 c.p.r. § 46.102(d) (2011). 2. while this article uses the general term "drug," the risks to the public from medi­ cal devices, such as pacemakers. biologics. such as blood clotting agents, and vaccines, are equally serious, and rather than highlight the differences, this article will emphasize the simi­ larity of risk. proposals to protect individuals with knowledge of dangerous procedures used to develop a drug which would be a risk to public health apply equally strongly to any medi­ cal product requiring approval of the food and drug administration pursuant to its general authorizing statute, the federal food, drug, and cosmetic act. see 21 u.s.c. § 393 (2011). 3. the fda bas not always had this authority. untill962, drugs were automatically approved for sale if the fda did not act within sixty days. many drugs currently on the market were submitted under that schema and have never been approved by the fda. see caitlin e. fleming, overdosed and contaminated: a critical examination of the fda and drug industry's role in drug sqfety in the context of the heparin catastrophe, 13 qulnnipiac health l.j. 117, 150 (2009) (reviewing the history of bow drugs like heparin were approved without active fda approval and describing the fda's current abilities to oversee drugs after hitting the market). see also renewed legislation improves safety of fda-regulated products, fda, http://www.fda.gov/forconsumers/consumerupdates/ ucm061229.htm (last updated jan. 18, 2012) (explaining that the food and drug administra­ tion amendments act of 2007 provided the fda with funds to oversee clinical trials and to review television marketing aimed at consumers); significant amendments to the fd&c act, fda, http://www.fda.gov/regulatorylnformation!legislation!federalfooddrugandcosmetic actfdcact/significantamendmentstothefdcact/default.htm (last updated apr. 29, 2011); inspections, compliance, enforcement, and criminal investigations, fda, http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanuallucm074 382.htm (last updated sept. 16, 2011) (describing the fda's 1962 grandfather clause policy exempting a drug from the effectiveness requirement "if its composition and labeling has not changed since 1962 and if, on the day before the 1962 amendments became effective, it was (a) used or sold commercially in the united states, (b) not a new drug as defined by the fd&c act at that time, and (c) not covered by an effective application"). 4. eliot spitzer, regulators and risk-takers: didn't big pharma or the fda learn anything from the gulf oil spill or the wall street meltdown?, slate (july 14, 2010), http://www.slate.com/id/2260470/. while fda regulation requires drug companies to halt clinical trials if there is evidence of undue risk, it must rely on the company's own judgment 4 indiana health law review [vol. 9:1 cannot be anticipated, others may be suppressed because they are against the manufacturer's financial interest. · sadly, many recent examples point to such deliberate omissions. for example, the pharmaceutical company glaxosmithkline withheld negative information suggesting that a vandia, a popular drug used by diabetics, in­ creased the rate of heart attacks.5 concerned about the avoidable deaths, senator max baucus said that "information is the most important tool the fda has to protect american consumers, and the documents we uncovered in our investigation will help arm the fda with the best information possi­ ble as it evaluates avandia's safety."6 similar allegations have been made against merck & company, manufacturer of vioxx. evidence disclosed during a series of lawsuits against vioxx exposed information demonstrat­ ing an increased rate of heart attacks, first among research subjects taking the drug and then patients.7 drugs that were intended to keep patients healthy instead resulted in thousands of patient deaths. it is the fragmented way research and drug development is structured in the united states which makes it so hard to protect the public. u.s. law divides human subjects' safety oversight into two separate jurisdictions: first, research funded by agencies of the federal govemment8 and second, drug trials paid for by phannaceutical companies.9 this article provides an overview of the current system with the goal of showing where these gaps are, why it is important to close them, and how difficult a task this will be. without understanding why and how the current uncoordinated, ramshack­ le, and weak laws specifically fail to protect the public's health it is impos­ sible to craft or implement effective change. this article, however, is not merely descriptive; it is also nonnative. it proceeds from the position that the federal government should protect the public against dangers from pre­ scription drugs and moreover that employees who work for drug manufacin either stopping the trial itself or disclosing the interim results to the fda. 5. gardiner harris, diabetes drug maker hid test data, files indicate, n.y. times (july 13, 201 0), http:/ /www.nytimes.com/20 i 0/07 /13/health/policy/13avandia.html. 6. press release, united states senate committee on finance, baucus, grassley find company failed to promptly alert fda about drug risks: finance leaders send find­ ings to fda regarding safety of diabetes drug avandia (july 13, 2010), http://finance. senate.gov/newsroom/chairmanlreleasel?id=bcf5aef6-9bc5-45ca-9cab-aadf5dfl35fa. 7. the manufacturer of vioxx, merck & co., inc., has neither admitted nor received official sanctions for deliberately concealing information. the allegations are that it was aware of a pattern of adverse events which it decided did not present a danger and therefore did not warrant disclosure to the fda. however, had there been a procedure for sending individual concerns directly to the fda, the fda might well have heard about the results earlier and made its own conclusions about the significance of the data. see generally rena steinzor & margaret clune, the hidden lesson of the vioxx fiasco: reviving a hollow fda (2005), available at http://www.progressivereform.org/articles/vioxx_ 514.pdf (recounting the vioxx story and arguing that the fda has insufficient resources to conduct independent review of drug safety issues which emerge after marketing). 8. gardiner harris, the safety gap, n.y. times (oct. 31, 2008), http:/ /www.nytimes.com/2008/11/02/magazine/02fda-t.html. 9. about phrma, pharmaceutical res. & mfrs. of am., http://www.phrma.org/ about/about-phrma (last visited dec. 30,201 1). 2012] whistleblower protection for medical researchers 5 turing and development companies should receive adequate protection for bringing information about these dangers to a regulatory agency with the power to address them. since the food and drug administration (fda) controls every aspect of the development, production, and marketing of a drug to be sold in the united states it is the obvious choice for this role. 10 because the fda already has umbrella jurisdiction over drug devel­ opment, production, and marketing, the reform proposals made in this arti­ cle can be implemented directly through the agency's own rule making authority and once done will extend protection to every participant in a drug trial and every consumer who later is prescribed that drug. as a result, those who voluntarily participate in drug trials are often exposed to dangers far beyond what they agreed to. in both cases, participants or insiders with the most knowledge are prevented from coming forward because of very real fears of retaliation and loss, not of their jobs, but of their careers. 11 improving information flow by developing a safe and effective whis­ tleblower procedure will not be an easy task. drug trials are complex and often occur at multiple test sites, both public and private, in many different states in the united states, as well as overseas.12 as a result, the pool of potential people with relevant knowledge is very large and transcends em­ ployment status, job title, or physical location. on the other hand, the target audience to receive complaints is very specific: the fda. this means that the protection available must be sufficient to encourage disclosure by high­ level scientists, doctors, or pharmaceutical company executives for whom disclosure would be career ending. 13 finally, to be effective, a solution i 0. it is a crime to distribute any drug in the united states without the fda's approv­ al. see 21 u.s.c. § 33l(a) (2010) ("the introduction or delivery for introduction into inter­ state commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded [is prohibited]."). 11. most employees in the united states are "employees at will" and therefore can be fired for any reason. federal employees have slightly more protection since they can be fired only for "cause." see 5 u.s.c. §§ 7501-7543 (2011) (providing a merit systems pro­ tection board for federal employees). members of a union also have protection against be­ ing fired without cause, but only 11.8% of american workers are members of unions. see economic news release, u.s. dep't of labor, union members summary (jan. 27, 2012), available at http://www.bls.gov/news.releaselunion2.nro.htm ("in 2011, the union member­ ship rate--the percent of wage and salary workers who were members of a union-was 11.8 percent, essentially unchanged from 11.9 percent in 2010 .... the number of wage and salary workers belonging to unions, at 14.8 million, also showed little movement over the year."). 12. search for clinical trials, cunicaltrials.gov, http://clinicaltrials.gov/ (last visited dec. 30, 2011). 13. whether or not a whistleblower is an employee, retaliation is a very real fear of individuals who criticize the pharmaceutical industry. a recent class action lawsuit in aus­ tralia revealed corporate documents outlining a plan to discredit physicians who were criti­ cizing vioxx. a reporter for a consumer blog who reported on the trial said, "court evidence show[ed] company employees drew up a 'hit list' of doctors, researchers, and academics who, it ... felt, had to be 'neutralized' or discredited from criticizing the drug." the reporter went on to quote an email by a merck employee that stated, ''we may need to seek them out 6 indiana health law review [vol. 9:1 must also recognize both the social science literature, which describes how whistleblowers are encouraged to come forward, and the advances in tech­ nology, which can make it possible to disclose information with less risk of retaliation.14 traditional whistleblower protection statutes are usually quite specific and often will only protect disclosures directly related to violations of a specific statute.15 without existing laws identifying prohibited behaviors, it is very difficult to extend protection to potential whistleblowers who may be located anywhere in the world and who may be independent contractors or be employed by either public or private entities. the fda cannot, as it is currently structured, take on the task of mon­ itoring and responding to a broadly conceived whistleblower program. importantly, this article does not criticize the fda's good faith attempt at overseeing the activity of drug companies, although others do. comment­ ing on the approval of the weight loss drug orliset, dr. sidney wolf, mem­ ber of the consumer advocacy group public citizen and frequent critic of the fda, described the agency's decision as "the height of recklessness and shows a profound lack of concern for the public's health."16 the reason this article does not address these criticisms is that if the fda is acting in bad faith, then any attempt at reform is fruitless. assuming, however, that the fda is committed to fulfilling its statutorily assigned function of pro­ tecting the public, then monitoring the suggested information is a problem that can be solved simply by money. part ii of this article reviews the dangers to the public from participat­ ing in clinical drug trials research and from taking prescription drugs. part iii provides a short history of how clinical drug trials came to be regulated and current fda regulations of research and oversight of clinical trials. part iv considers the actions of pharmaceutical companies after the drug trials are over and outlines the dangers to the public from companies' marketing of new drugs. it also explains the current trend toward conductand destroy them where they live." melanie segala, how big phanna threatens its critics, dr. johnny bowden's blog (june 6, 2009), http://www.jonnybowden.com/labels/ vi­ oxx.html. 14. darcy s. o'neil, technology and the whistleblower, articlegeek. http:/ /www.articlegeek.com/business/ethics _ articleslwhistleblower _ technology.htm (last visited dec. 31, 2011). 15. see richard moberly, protecting whistleblowers by contract, 79 u. colo. l. rev. 975, 982 (2008) ("although federal anti-retaliation protections collectively cover a broad range of industries, each of the individual statutes applies only to a specific type of employee who blows the whistle about a specific topic. this statutory framework results in a network of narrow protections that evolved on an ad hoc basis to support specific statutory schemes."). 16. press release, public citizen, fda approval of over-tile-counter orlistat is reckless (feb. 7, 2007), available at http://www.citizen.org/hot_issues/ print_issue.cfm?id=l539. see generally drugs, devices and supplements, public citizen, htip://www .citizen.org/p age.aspx?pid= 1249 (last visited nov. l 0, 2011 ). 2012] whistleblower protection for medical researchers 7 ing clinical trials overseas, as well as the trend toward even closer relation­ ships between pharmaceutical companies and the doctors and research sci­ entists employed by university affiliated academic medical centers. part iv also elucidates post-market dangers to the consumer and outlines the cur­ rent system of laws protecting medical researchers who want to bring the information forward. part v identifies the deficiencies of existing federal law to protect in­ siders with knowledge. this article identifies the paramount features any proposed regulation must include to provide adequate incentives for disclo­ sure. finally, the article addresses both substantive and normative issues raised as a result of this protection.17 this article is the first of a planned two-part series. it identifies the dangers to the public during drug testing and the marketing of a new drug and reviews the existing options for pro­ tecting those with knowledge. in a subsequent article, the author plans to offer a series of proposals which would offer further protection. all whis­ tleblower laws are premised on the idea that protection from retaliation will increase the likelihood the public will hear of potential dangers before being exposed to them.18 this article demonstrates why protection needs to come from the federal government and why these regulations are well within ex­ isting federal powers. ii. the scope of the problem: dangers to the public from medical research and prescription drugs a. dangers of medical research for human subjects consumer watchdog groups,19 doctors,2° congressmen,21 bioethi17. see generally courtney j. anderson dacosta, note, stitching .together the patchwork: burlington northern's lessons for state whistleblower law, 96 geo. l.j. 951 (2008); robert johnson, comment, whistling while you work: expanding whistleblower laws to include non-workplace-related retaliation after burlington northern v. white, 42 u. rich. l. rev. 1337 (2008); paul m. secunda, whither the pickering rights of federal employees?, 79 u. colo. l. rev. 1101 (2008). 18. stewart j. schwab, wrongful discharge law and the search for third-party ef­ fects, 74 tex. l. rev. 1943, 1966-68 (1996} (reviewing the extent to which whistleblowers fear retaliation and therefore require this protection from statutes). 19. see, e.g., news release, accenture, recent drug recalls leave physicians and consum.ers concerned about prescription drug safety (july 27, 2005), http://newsroom.accenture.com/article_display.cfin?article_id=4239#rel (surveying "more than 100 u.s. physicians and 500 u.s. consumers" and finding that "two-thirds (67 percent) of doctors and one-third (32 percent) of consumers have become more concerned about the safety of prescription medications since the recent removal from the market of popular pain relievers"). 20. in a comment attached to an article in the new york times about glax­ osmithkline's hiding of safety information about their drug avandia dr. rick lippin of southampton, penn., wrote, as a physician i am really very weary of reading these many stories in 8 indiana health law review [vol. 9:1 cists,22 legal academics,23 and courts24 have all noted with concern the risks the public faces both from participating in medical research and in taking the drugs which emerge from the process. in order to adequately appreciate a proposal to decrease the dangers from prescription drugs, it is necessary to understand the scope of the problem both in terms of existing dangers and in terms of the complexities of the existing regulatory protections. every prescription drug sold in the united states reaches the market through testing on brave and often altruistic individuals who take the risks of testing new and untried products.25 these volunteers are part of a multi­ faceted and complex system in which ideas and discoveries in laboratories are transformed into the drugs, devices, and vaccines prescribed to the gen­ eral market. 26 . regardless of bow much promise a drug shows in laboratory or even animal testing, it must eventually be tried on the human patients for whom it is intended.27 this is sometimes a dangerous process that can lead to injury and deatb.28 recent years. it is obvious that fines, lawsuits and bad publicity are not working. the only method of stopping these behaviors is to charge the most egregious ceos of big phrma [sic] with crimes and to sentence them to jail. see harris, supra note 5, at cmt. 121. 21. asked for his opinion in the same article about allegations that glaxosmithkline had hidden safety information about avandia, senator max baucus said, "when drug com­ panies withhold data regarding safety concerns about their medicines, they put patients at risk." harris, supra note 5. 22. susan gilbert, industry-funded drug trials: devils in the details, the hastings center: bioetidcs forum (aug. 10, 2010), http://www.thehastingscenter.org/ bioeth­ icsforum/post.aspx?id=4823&blogid= 140. 23. rebecca dresser, time for new rules on human subjects research?, 28 hastings center report 23, 23-24 (1998). 24. see, e.g., grimes v. kennedy krieger inst., inc., 782 a.2d 807, 815-17 (md. 2001). 25. see what is the approval process for a new prescription drug?, fda, http://www.fda.gov/aboutfda!transparency/basics/ucm194949.htm (last visited dec. 31, 2011) ("drug companies seeking fda approval to sell a new prescription drug in the united states must test it ... in humans to see if the drug is safe and effective when used to treat or diagnose a disease."). 26. /d. 27. detailing the need for further protection for the first humans to test a drug devel­ oped through laboratory and then animal testing, rebecca dresser reminds us that "[w]e should not lose sight of an uncomfortable reality: [these] trials expose healthy people with limited economic opportunities and ill people with limited health options to harm for the benefit of others." rebecca dresser, first-in-human trial participants: not a vulnerable population, but vulnerable nonetheless, 37 j.l. med. & ennes 38, 47 (2009). 28. see robert steinbrook, the gelsinger case, in the oxford textbook of clinical research ennes 110 (ezekiel emanuel et al. eds., 2008) for an account of one of the most defining cases involving the death of a teenage research subject. the public is well aware that neither pharmaceutical companies nor academic medical centers have done all they should to protect human subjects. almost 25% of people surveyed by the harvard school of public health believed that most pharmaceutical companies acted unethically when testing new drugs on people. usa today, kaiser family found. & harvard sch. of pub. health, the public on prescription drugs and pharmaceutical companies 22 fig.29 (2008), available at http:/lwww.kff.org/kaiserpolls/pomr030408pkg.cfm. see also 2012] whistleblower protection for medical researchers 9 compared to the information available on sickness and death caused by drugs already on the'market, the information on harm from drugs while they are being researched and developed is quite scanty.29 there is no cen­ tral registry of harm suffered by participants in drug trials. 30 experts esti­ mate that between ten and nineteen million americans participate in the testing and development of prescription drugs.31 not all of these experi­ ments end well. there may well be up to ten thousand research-related deaths occurring per year, which is proportionate to normal death rates among a population between ten and nineteen million research subjects.32 direct access to research-related adverse effects is often unavailable since there is not direct access to such information because, whether drugs· are developed by private companies or in academic medical centers, those with knowledge face not just dismissal, but lawsuits for violations of strict con­ fidentiality and non-disclosure agreements.33 the history of medical research in the united states is marked by frightening incidents in which participants in drug trials were killed or seri­ ously injured despite elaborate regulations intended to protect them. medianna c. mastroianni, sustaining public trust: falling short in the protection of human research participants, hastings ctr.. rep. (2008) (citing the usa today statistic in a call for greater protection of human subjects and stating, ''to create accountability, the public needs to be assured that processes are in place to protect research participants."). 29. see mark greener, first do no harm: improving drug safety through legisla­ tion . and independent research, 9 embo reports 221 (2008), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2267386/pdf7embor200817 .pd£ 30. sarah rubenstein.· when drug trials go wrong, patients have little recourse, wail st. j. (jan. 31, 2008), http://online.wsj.com/article/sb120173515260330205.html (showing compensation plans for harmed participants vary by institution and despite calls to standardize compensation programs, adoption is minimal). 31. in 2001, dr. adil e. shamoo, a highly respected expert in human subject research, published the results of a study he conducted to estimate the number of humans participating in medical research and the number suffering injury or death as a result. noting that the report of only ·eight deaths in federally funded research studies over ten years was "absurdly low," he estimated the actual number of ittjuries every year in the "tens of thousands" and the "deaths in the thousands." he found it necessary to estimate these figures because the way human subject research is organized in the united states precludes any access to com­ prehensive data. he analyzed available information from an array of government sources including tracking studies funded by the national institutes of health and those funded by pharmaceutical companies and non-govemmental sources wbich were under the jurisdiction of the food and drug administration because they were intended to si.tppc>rt an application for an investigational new drug ("ind"). dr. shamoo's failure to identify any reliable source of either the number of people participating in human subject research or their rates of injury or death provides a helpful overview of how human subject research and new drug development is regulated in the united states. see adil e. shamoo, adverse events report­ ing: the tip of an iceberg, 8 accountabiuty in res. 197 (2001). 32. shamoo, supra note 31, at 198. 33. see stewart lyman, pharma-academic alliances: what the numbers don't tell you, xconomy (may 10, 2011), http:/lwww.xconomy.com/seattle/2011/05/10/pharmil­ academic-alliances-what-the-numbers-dont-tell-youl (last visited mar. 17, 2012); see also the corrupt alliance of the psychiatric-pharmaceutical industry, citizens commission on human rights international, http://www.cchrintorglcchr-issues/the-corrupt-alliance-of-the­ psychiatric-pharmaceutical-industry/ (last visited mar. 17, 2012). 10 indiana health law review [vol 9:1 cal research, one of the most respected endeavors of modem society,34 has turned out to be an enterprise full of risk and menace. at the same time, prescription drug consumption in the united states has increased every year.35 today, any clinical trial conducted with intent of providing support for a new drug application (nda) must comply with the human subject research protections of the "common rule" which applies to all research both funded by and overseen by any federal agency.36 the transition from limited and closely monitored trials involving a small number of patients to the actual marketing of the drug to the general public has been described as "stage 5" testing because it is often only then that serious side-effects and counter-indications become known.37 a series of front-page stories in the new york times during the sum­ mer of 2010 tells the story of how one of the largest pharmaceutical compa­ nies went to extraordinary efforts to hide the dangers of avandia, a drug that increased the risk of heart attack for the diabetic patients to whom it was prescribed.38 describing the studies offered by the company in support of its product as "totally incorrect and deceptive,"39 members of the fda panel which was convened to review the charges criticized the company's failure to protect the public from risks of which it was well aware. these allegations echoed those made in a lawsuit brought in 2004 by the state of new york against glaxosmithk.line for allegedly concealing known dangers of suicide by children and adolescents using its prescription 34. depending on the question asked, the public's views of science, technology, and medicine can differ, but in genera], efforts viewed to improve health ate viewed with favor by the american public. see dov greenbaum, research fraud: methods for dealing with an issue that negatively impacts society's view of science, 10 colum. scr. & tech. l. rev. 61, 65 n.io (2009) ("science studies what is; technology creates what never was." (quoting d. allan bromley, sheffield lecture at yale university: science, technology, and politics (mar. 22, 2001))). 35. qiuping gu et al., prescription drug use continues to increase: u.s. prescription drug data for 2007-2008 1 (2010) (showing trends in prescription drug use in the united states over the years 1999-2008), available at http://www.cdc.gov/nchs/data/ databriefs/db42.pdf. see also wayne kondro & barbara sibbald, drog company experts advised staff to withhold data about ssrj use in children, 170 canadian med. ass'n j. 783, 783 (2004), available at http://www.cmaj.ca/cgi/content/full/170/5!783. 36. federal policy for the protection of human subjects ('common rule}, u.s. dept. of health & human servs., http://www.hhs.gov/ohrplhumansubjects/commonrule/ index.html (last visited feb. 3, 2012); 45 c.f.r. § 46.10l(a) (2012) ("[t]his policy applies to all research involving human subjects conducted, supported or otherwise subject to regula­ tion by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research."). 37. glossary: clinical trials terminology, applied clinical trials, dec. 2002, at. 30, available at http://staff.aub.edu.lb/-webmedic/appendixl4.pdf ("postmarketing surveil­ lance is sometimes referred to as phase 5."). 38. harris, supra note 5. 39. gardiner harris, f.d.a. panel votes to restrict avandia, n.y. timbs (july 14, 2010), http://www.nytimes.com/2010/07/l5/health/policy/l5diabetes.html (quoting dr. wil­ liam knowler's description of another glaxosmithkline study). 2012] whistleblower protection for medical researchers 11 anti-depression drug paxil.40 while the identities of most research subjects are known only to their families, there are several very famous examples to the contrary. perhaps best known is eighteen-year-old jesse gelsinger who died while participat­ ing in a genetic therapy study that was of no medical value to him but of considerable value to his physician who had created a company to market the therapy to others.41 another youth, ellen roche, a johns hopkins lab technician, volunteered to test an anti-asthma medicine and died a month after her lungs were damaged fatally because the researcher had induced lung spasms using a drug that had never been approved for use in humans.42 in the face of these tragedies, it is reasonable for americans to ask why the seemingly vast array of laws and regulations intended to ensure the safety of both research subjects and those who eventually use the products tested could have failed so dramatically and what steps can be taken to prevent future harm. b. the importance of improved prescription drug regulations due to in­ creasing use in us. culture prescription drug use has permeated american society. in the news 40. complaint, new york ex rei. spitzer v. glaxosmithkline plc, (n.y. 2004), available at http:/ /fll.findlaw .com/news. findlaw .com/cnn/docs/glaxo/nyagglaxo60204cmp. pdf(last visited feb. 4, 2012). 41. see generally robin wilson, the death of jesse gelsinger: new evidence of the influence of money and prestige in human research, 36 am. j. l. & med. 295 (2010). alt­ hough ethicists and researchers at the university of pennsylvania defended the integrity of the experiment, the university reached a non-public settlement with the family and the lead investigator was banned for five years from doing human subject research again. see cheryl g. stolberg, institute restricted after gene therapy death, n.y. times (may 25, 2000), http://www.nytimes.com/2000/05/25/us/institute-restricted-after-gene-therapy­ death.html?ref.'<jesse _gelsinger. in an interview with scientific american about an article the fda required he write about lessons learned, the reporter quoted him as stating that he "would not do the study again" and then paraphrased his explanation: "in the 1990s scien­ tists such as himself, he explains, were too caught up in the promise of gene therapy to real­ ize that they did not know enough about it to warrant human testing. we were drawn into the simplicity of the concept. you just put the gene in." he further advised future research­ ers to avoid conducting research in which they had a conflict of interest. melinda wenner, tribulations of a trial: lessons learned by the scientist behind the first gene therapy death, sci. am., sept. 2009, at 14--15. 42. for an overview of recent cases in which research subjects were harmed, see gen­ erally marshall s. shapo, experimenting with the consumer: the mass testing of risky products on the american public 18-29 (2009). the risks are especially high in tests for new psychiatric medications because the fda requires that their effectiveness be compared against no treatment at all. thus, patients with documented psychiatric conditions must be taken off all medication for a period long enough for their old medicine to "wash­ out" of their body so that the effects of the experimental drug can be measured accurately. see peter r. breggin & ginger ross breggin, talking back to prozac: what doctors aren't telling you about today's most controversial drug 84, 224 (1994). 12 indiana health law review [vol. 9:1 doldrums of july 2010, sixty-nine percent of the american public, including president barack obama,43 knew lindsey lohan was spending some time in jail.44 a feature of many of these stories was the number of powerful prescription drugs she took on a daily basis.45 this picture of a young woman with no life-threatening disease taking six different powerful pre­ scription drugs is, unfortunately, an accurate reflection of daily life in the united states at the turn of the twenty-first century. we have become a nation of drug-takers. 46 one of the reasons for this is the increased use of prescription drugs by increasingly broad segments of the population. fifty­ nine percent of all americans, and eighty-six percent of all seniors, take a prescription drug47 every day.48 there are many explanations for the in­ creasing number of i(\juries suffered by those taking prescription drugs as 43. interviewed by the hosts of the abc talk show "the view' on july 29, 2010, president obama responded to a series of questions about his knowledge of popular culture, st;tting that "he knew lindsay lohan was in jail.'' jessica derschowitz, "the view": obama talks about his ipod, lindsay lohan t:mtj his daughters, cbs news (july 29, 2010), http://www.cbsnews.com/8301-31749_162-20012103~10391698.html. 44. this figure is according to the pew research center for people and the press, which reports that of americans polled between july 8 and ll, 2010, twenty-seven percent had heard "a lot" about lindsay lohan being sentenced to jail and forty-two percent had heard "a little." press release, pew res. ctr., modest decline in oil leak interest, sharp decline in coverage (july 14, 2010), available at http://www.people-press.org/files/legacy..: pdt7634.pdf. 45. according to mtv news, lohan is cleared to take the antidepressants zoloft and trazodone; ad­ derail, a stimulant used to· control adhd; the acid-reflux medicine nexium; and the very powerful painkiller. dilaudid, whose effects have been compared to heroin and which she was originally prescribed after dental surgery several months. ago. lohan is subject to random drug and alcohol testing, but because those .drugs have been court-approved, posi­ tive tests for them are not considered violations. see gil kaufinan, why is lindsay lohan on so ma1ry medications? 71's too complicated a picture to add medications into the mix so soon,, one doctor tells mi'v news, mtv news (july 8, 2010), http://www.mtv. com/news/articles/1643256/why-lindsay-lohan-on-so-many­ medications.jhtml. for a copy of the probation report, see probation officer's report, cali­ fornia v. linds.ay dee lohan, no. 7bv01538..:01 (cal. sup. ct. july 6, 2010), available at http://tmz.vo.llnwd.net/o28/ newsdeskltmz_documents/072l_lohan.pdf. 46. the age-adjusted percentage of the population using at least one prescription drug during the previous month increased from thirty-nine percent for 1988-1994 to forty-seven percent for 2005-2008. during the same periods., the percentage taking three or more pre­ scription drugs increased from twelve percent to. twenty-one percent u.s. dep't of health and human servs.: nat'l ctr. for jieal'ih statistics, health, united states, 2010: with special feature on dea'ih and i>yjng 318 (2011), available at http://www.cdc.gov/ nchs./datalhus/husl o.pdf. 47. see study shows more americans taking prescription drugs, u.s.a. today (may 14, 2008), http://www.usatoday.com/news!health/2008-05-14-medication-nation_ n.htm (stating that "more than half of all insured americans are taking prescription medi­ cines regularly for chronic health problemsj. 48. linda l. barreti, prescription drug usb among mid-life and older americans 5 (2005), available at http://assets.aarp.org/rgcenter/health/rx_midlife_plus.pdf (s.tating that three-quarters of americans age fifty or older s.ay they currently take prescrip­ tion drugs on a regular basis). 2012] whistleblower protection for medical researchers l3 directed by their physicians. the cdc attributes the phenomena to the de­ velopment of new categories of drugs to treat chronic conditions such as high cholesterol and diabetes.49 others point to increased advertising by drug companies including direct-to-consumer advertising in magazines and on television.50 c. why regulations are necessary for human subject research in the united states the genesis of regulation of all research involving human subjects in the united states is traced traditionally to the horrors nazi doctors and sci­ entists inflicted on concentration camp prisoners, as revealed during the nuremberg war crimes trial.51 the core principle of the nuremberg doc­ trine, later incorporated into an international treaty called ''the helsinki accord," was the mandate that·au research conducted with human subjects must be done with a subject's informed consent. 52 the helsinki accord has become the foundation of whatever international understanding exists on the boundaries for conducting ethical human subject research. 53 because the united states' research community did not see a connec­ tion between the research it was doing and the activities of the nazis, it took over thirty years for the principles developed in helsinki and nuremberg to become u.s. law. 54 as professor jay katz observed in explaining the de49. see u.s. dep't of realm and human servs.: nat'l ctr. for health statistics, realm, united states, 2009: with special feature on medical technology 94 (2010), available at http://www.cdc.gov/nchsldatalhuslhus09.pdf ("the use of statin drugs increased almost 10-fold from 1988-1994 to 2003-2006; during the same time period, the use of antidiabetic drugs increased by 50010."). 50. for a history of how pharmaceutical companies came to be allowed to advertise directly to consumers, see francis b. palumbo & c. daniel mullins, the development of direct-to-consumer prescription drug advertising regulation, 57 foon & drug l.j. 423 (2002). 51. there are many overviews of this period in history. the original transcripts of the trials can be found at trials of war criminals before the nuernberg military tribunals un­ der control council law no. 10: october 1946-april 1949, libr. cong., http://www.loc.gov/rr/frd!militarylaw/nts _ war-criminals.html (last updated july 16, 20 l 0). see generally gail h. javitt, old legacies and new paradigms: confusing "research" and "treatment" and its consequences in responding to emergent health threats, 8 j. healm carel. & pl'y 38, 44-49 (2005) (providing a history of the nuremberg doctors trials' role in developing the nuremberg code). see also alan t. lefor, scientific misconduct and unethical human experimentation: historic parallels and moral implications, 21 nutrition 878 (2005). 52. samantha evans, the globalization of drug testing: enforcing informed consent through the alien tort claims act, 19 temp.int'l& comp. l.j. 477,487 (2005). 53. id (conceding that "there is currently no controlling legislative or executive act to establish that informed consent in human subject experimental research is a 'law of na­ tions,"' but arguing that it has gained the status of "binding customary international law" by considering the helsinki doctrine together with succeeding, but separate, guidelines and declarations). 54. carla m. stalcup, reviewing the review boards: why institutional review board 14 indiana health law review [vol. 9:1 lay, "it was a good code for barbarians, but an unnecessary code for ordi­ nary physicians."55 instead, the activities exposed at nuremberg were seen as the result of extraordinary circumstances that were outside the usual con­ duct of scientific research. the first steps towards legal regulation of research involving living humans came in the wake of congressional hearings, which considered henry beecher's 1973 report detailing the history of human subject re­ search abuse, not by foreign monsters, but rather by highly respected doc­ tors and scientists within the united states.56 this was followed the next year by the revelations of the syphilis trials conducted by the public health service on african-american sharecroppers in tuskegee, alabama ("the tuskegee study").57 moreover, these scandals are strikingly alike in that liability does not make good business sense, 82 wash. u. l.q. 1593, 1596-97 (2004). 55. the nazi doctors and me nuremberg code 227-239, oxford university press, new york (george j. annas & michael a. grodin eds., 1992). 56. henry beecher, ethics and clinical research, 274 new eng. j. med. 1354 (1966) (describing unethical human subject experiments conducted in the united states after world war ii for the purpose of highlighting the need for greater oversight). 57, james h. jones, bad blood: the tuskegee sypidus experiment (1981) (rec­ ognized as the definitive history of the now much..(}ocumented tuskegee study). see also javitt, supra note 51, at 47-49 (2005) (providing a chronological history of the events lead­ ing up to the united states' decision to adopt laws regulating human subject research). the tuskegee study, perhaps misleadingly named since it was funded and conducted by the u.s. public health service in tuskegee, alabama, has become an iconic representation of the worst kind of abuse since the researchers not only failed to provide subjects with curative antibiotics, when they became available in the mid· 1940's, but also instructed local doctors to turn away subjects untreated if they sought help outside of the study. see jones at 12. this study is portrayed in a 1992 play entitled ms. evers' boys by david feldshuh, which was made into an emmy·winning televised movie by hbo in 1997. miss evers' boys (home box office 1997). see also miss evers' boys, n.y. univ. literature, arts, & med. database,_http:/ /litmed.med.nyu.edul annotation?action=view&annid= 10060 (last visited feb. 6, 2012). see also jerry menikoff, could tuskegee happen today?, l st. louis u. j. health l. & pol'y 311 (2008) (reviewing contemporary failures of researchers to disclose rel.evant information to human subjects and concluding that the contemporary irb system is not a guarantee that subjects are provided adequate disclosure). see also robert l. kerr, unconstitutional review board? considering a first amendment challenge to irb regulation of journalistic research methods, 11 comm. l. & pot'y (special issue) 393, 393 (2006) (recounting the history of the legal regulation of human subject research in the united states). kerr writes, "[t]he genesis for the system of institutional review boards now in place across the united states was the revelation of shocking abuses in the tuskegee study on the progression of syphilis conducted between 1932 and 1972." id. kerr further argues that requiring irb approval for research conducted by interviewing people violates the first amendment, what he describes as "journalistic" research methods, since these prac­ tices would be protected from state regulation if done in the context of journalism. /d. the difference between the two activities, however, is that research studies involving interviews are funded by the federal government while interviews conducted by journalists are not. see id dr. jonathan moreno, whose foundational book undue risk documents the radiation experiments the united states conducted on its own citizens, suggests that the bizarre activi· ties of sadists like dr. josef mengele are horrifying, but do not reflect the magnitude of suf­ fering and genocide. jonathan d. moreno, undue risk: secret state experim:ents on humans 53-75 (2001). in addition to the radiation experiments, moreno provides a history of abuses including the army's lsd experiments and the public health services' infamous tuskegee syphilis experiments. moreno writes, 2012] whistleblower protection for medical researchers 15 almost all of them involve researchers ofhigh repute and good will who are for some reason blind to the ethical violations of their research.58 as are­ sult, an account of human subject research from 1945 to the present day consists of one horror story after another. ill. how drug development occurs in tile united states human subject research either funded or regulated by the federal government is subject to the provisions of 45 c.f.r. § 46.101(a), which is often called the "common rule" because it applies to most federal agencies including the fda. before human subject research can be conducted today, it must be approved by an institutional review board ("irb"). professors maxwell j. mehlman and jessica berg summed up the process in the cor­ rect order and explained, "there are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects' informed consent."59 a. the fda's role of goalkeeper the fda must approve all drugs and medical devices sold in the some of the nazi experiments are now so familiar as to have become a part of popular culture. many have been morbidly fascinated by the no­ torious dr. josef mengele, who escaped germany for brazil, where he lived out his life in hiding. characters based on mengele have even ap­ peared in several popular movies. his sadistic experiments, such as those he performed on helpless children, especially twins, were appar­ ently motivated by a wish to achieve an honored place in the history of medical anthropology, in 'racial science.' but the nonsense of some of mengele's more infamous efforts, like injecting dye in brown eyes to see if he could turn them blue, is a distraction from a major portion of the abuses of the human beings in the camps--jews, gypsies, poles, rus­ sians, political prisoners, and others. for the bulk of that research was part of a systematic program in support of the nazi war effort. id. at 54. moreno warns that what should be of much more concern to us today are the equally cruel experiments that directly served the nazi war interest by documenting the ex­ tent of human endurance in conditions such as high altitude or icy water likely to be experi­ enced by combat troops. see id. at 60. see generally mary r. anderlik & nanette elster, currents in contemporary ethics, 29 j.l. med. & ethics 220, 222 n.28 (2001) (quoting r. faden and t. beauchamp, removing 'deficiencies' in human research, balt. sun, mar. 5, 2000, at 3c). 58. see susan lederer, subjected to science (1995) (reviewing the history of medical experimentation in the united states before world war ii). 59. maxwell j. mehlman & jessica w. berg, human subjects protections in biomed­ ical enhancement research: assessing risk and benefit and obtaining informed consent, 36 j.l. med. & erm:cs 546, 546 (2008) (developing a legal and ethical framework for evalu~ ating experiments involving human enhancement that are not intended to treat a medical condition but which have the likely result of affecting permanent change in some of the sub­ jects). 16 indiana health law review [vol. 9:1 united states. 60 the first step in extending whistleblower protection is to make such protection mandatory for all companies seeking investigational new drug approval from the fda. the fda reviews products submitted to it for safety and for efficacy.61 until relatively recently, the fda's role was primarily restricted to events occurring after human subject testing had end­ ed. that was because medical research was limited to reviewing any appli­ cations for approval of products that were the result of the research. increasingly, however, the fda's role as gate-keeper to the public has re­ sulted in its taking a more active role in the regulation of the research pro­ cess. unfortunately, even here the effect has been far less than complete protection because, although recent regulations require some disclosure, there are still serious gaps.62 the supreme court has twice in recent history upheld the federal gov­ ernment's power to make colleges and universities comply not just with federal law but also with federal policy. bob jones university v. united states held that the university could be stripped of its tax-exempt status if it continued its religiously based policy of banning inter-racial dating.63 writ­ ing about the decision, professor martha minnow notes that the court did not base its decision on violation of a specific statute so much as it "rea­ soned that the tax exemption, as a privilege, had to comport with law and public policy; and then the court relied on changes in american society even more than changes in legal doctrine.'.m since bob jones the supreme court has both enforced federal regulations, which directly target activities on campus65 and upheld the government's argument that failure to comply 60. see generally christine d. galbraith. dying to .know: a demand for genuine public access to clinical trial results data, 18 miss. lj. 705, 713-20 (2009) for an over­ view of the fda drug approval process. see also development & approval process (drugs), u.s. food & drug admin., http://www.fda.gov/drugs/developmentapproval process/default.htm (last visited feb. 8, 2012) for the fda's own description of the drug approval process. the fda was established in 1906 pursuant to the pure food and drug act, pub. l. no. 59-384, 34 stat 768. its regulatory authority has evolved over time. in 1938 congress passed the food, drug, and cosmetic act of 1938, pub. l. no. 75-717, 52 stat. 1040, which superseded the pure food and drug act and extended the fda's authori­ ty. its enabling statute has been further amended since. 61. 21 u.s.c. § 355(d)(5) (2008) (requiring that pharmaceutical companies provide "substantial evidence" of their product's efficacy). today, "data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness ... [and] to constitute substantial evidence." id (corresponding to the food and drug administration modernization act of 1997, pub. l. no. 105-115, § 103, 111 stat. 2296 (1997)). 62. see, e.g., galbraith, supra note 60, at 741-51 (criticizing u.s. federal clinical trials results database as not adding significantly to the public's knowledge). 63. bob jones univ. v. united states, 461 u.s. 574. 605 (1983). 64. martha minnow. should religious groups be exempt from civil rights laws?, 48 b.c. l. rev. 781, 797 (2007) {''the opinion reasoned. '[t]here can no longer be any doubt that racial discrimination in education violates deeply and widely accepted views of elementary justice . .., (quoting bob jones univ. v. u.s., 461 u.s. 574, 594 (1983))). 65. rumsfeld v. forum for academic & institutional rights. inc., 547 u.s. 47,60-61 2012] whistleblower protection for medical researchers 17 with federal policy could result in the complete elimination for eligibility of all federal funding including financial aid and research grants. b. the fda 's rule making authority the fda has the authority to issue its own rules so long as they sup­ port the intent of the statutes and regulations which they are intended to en­ force. while all executive branch agencies have this power, the fda has more ability than most because there is no requirement that it engage in ne­ gotiated rule-making with outside stake-holders.66 no drug can be sold in the united states without the approval of the fda.67 this approval comes through submission of an investigational new drug application, which is supported by research intended to prove to the fda's satisfaction that the proposed drug is both safe and effective.68 by setting standards for accept­ ability of supporting research, the fda has considerable control over the way research studies are conducted.69 for example, because the fda requires that psychiatric drugs be proved effective in comparison to no treatment at all, anyone seeking to gain approval for a new psychiatric drug must conduct human subject trials in which some patients receive a placebo, no treatment, and others the ac­ tive drug being tested.7° for other types of drugs, the fda requires that the new drug be treated against the current best available treatment. thus, a company wishing to market a new blood pressure medication need not set up a trial in which some patients with high blood pressure receive no treat­ ment at all while others receive the new drug. it does this by establishing its own criteria for the contents of investigational new drug applications.71 therefore, all research intended to result in a drug to be sold in the united states comes under the jurisdiction of the fda.72 research funded directly by the federal government is also subject to separate, and often different, regulations. as a practical matter, this means that privately funded human subject research that will not be used to support an investigational new drug application and is not conducted in or by an institution that receives (2006) (holding that private universities must allow military recruiters on campus or risk eligibility for all federal funding). 66. julia kobick, negotiated rulemaking: the next step in regulatory innovation at the food and drug administration?, 65 food & drug l.j. 425, 434 (2010) ("fda has never voluntarily convened a rulemaking negotiation, and congress has never statutorily mandated that fda establish an ad hoc negotiated rulemaking committee."). 67. w. christopher matton & f. scott thomas, the continuing balance: federal regulation of biotechnology, 44 jurimetrics j. 283, 293-94 (2004). 68. /d. at 295-96. 69. !d. at 297-98 70. see steve silberman, placebos are getting more effective. drngmakers are des­ perate to know why., wired (aug. 24, 2009) ("today, to win fda approval, a new medica­ tion must beat placebo in at least two authenticated trials."). 71. matton & thomas, supra note 67, at 295-96. 72. !d. at 294. 18 indiana health law review [vol. 9:1 federal funding is essentially unregulated. 73 c. existing fda protections insufficient to protect research subjects congress has tried to address the problem of suppression of both harm to human subjects and negative information stemming from the trial by re­ quiring those interested in eventual fda approval to register studies in ad­ vance. the result has been a series of new regulations, starting in 1997 with the food and drug administration modernization act/4 which require the actual registration of trials but do not require information about re­ sults.75 current regulation requires that sponsors of "controlled clinical inves­ tigations" of "drugs and biologics" must register their clinical trials at the website clinicaltrials.gov in accordance with section 801 ofthe food and drug administration amendments act of 2007 (fdaaa).76 seeing this requirement coming, many drug companies have voluntarily developed their own trial registries in which they promise to publicize the results of their drug trials, but in the absence of comprehensive regulation these regis­ tries contain no more than what the company wishes to disclose.77 howev­ er, the obligation to register trials does not extend to posting reports of 73. federal law says nothing about the extent of its application to research conducted at a stand-alone research facility, such as a biotechnology company, which is entirely pri­ vately funded. given the absence of any action by the federal government, it is fair to as­ sume that private facilities are unregulated although of course bound by the requirements of local criminal and tort law. see matton & thomas, supra note 67, at 319 ("[i]t is currently unclear whether dhhs would consider extending the scope of its regulatory jurisdiction to encompass privately funded biotechnology-related research where equipment or other facili­ ties used by participating academic or private corporations were previously funded by unre­ lated federal grants. current dhhs regulations simply do not address this issue."). 74. food and drug administration modernization act of 1997, pub. l. no. 105-115, § 301, ill stat. 2296. 75. see id. 76. see nat'l lnsts. of health, fact sheet: regis'iration at clinicaltrials.gov (2009), available at http://prsinfo.clinicaltrials.gov/s801-fact­ sheet.pdf; public meeting on expansion of the clinical trial registry and results data, 74 fed. reg. 12138 (mar. 23, 2009), available at http://prsinfo.clinicaltrials.gov /clinical_ trials _frn31609 _post .pdf; bridget m. kuehn, clinical trials registry ex­ pands, 302 jama 1, 22 (2009); see generally principals of medical research and clinical trial registry, fda.oov, http://www.fda.gov/ohrms/dockets/ac/04jbriefing/2004-4065b 129-lilly-attachment-2-clinical-trial-registry.pdf(last visited aug. 1, 2009); see also food and drug administration amendments act of2007, pub. l. no. 110-85, § 301121 stat. 823, 922 (further broadening fda's authority to do post-market testing). 77. merck kgaa has promised to make the basic results of its trials (except phase i) available on a publicly accessible database (clinicaltrials.gov results database). this applies to trials with a product for which approval for marketing in a single country has been re­ ceived, irrespective of the location and outcome of the trials. merck, merck perspective: clinical trial registries and the publication of clinical trials (2012), http://www. merck.com/research/discovery-and-development/clinical-development/merck-perspective­ clinical-trials.pdf (last updated jan. 20 12). 2012] whistleblower protection for medical researchers 19 adverse events. pharmaceutical companies are reluctant to do this because such information would damage them commercially either by giving infor­ mation to their competitors or by exposing them to liability or by causing damage to their reputation. 78 one of the most substantial of these is the failure of a legal require­ ment to report adverse events during a clinical trial.79 after reviewing what they describe as "several hundred clinical trial registries around the world" the philosophers concluded that "[a ]ii of these policies fall short of ensuring that adverse clinical trial results are disclosed to prospective participants in clinical trials.'.so their power to do that comes in the form of requiring ap­ plicants to certify that specific conditions were met in the research and de­ velopment process.81 one of the on-going problems in regulating medical research is that there has been no legal obligation for anyone conducting such research to disclose information to the fda before submitting an ap­ plication for approval. 82 a study conducted at a publically funded institution or with govern­ ment funds would have to be reviewed by an institutional review board at the home institution, but even then, the process is an internal one without outside review.83 a private company or an entity outside of the united states has no legal. obligations whatsoever to make any disclosures unless it seeks to market the product of the research in the united states. 84 that means if no application for approval is filed, no one would ever know that the study took place. d. fda authority to regulate clinical trials since the fda already has statutory authority to regulate the testing and marketing of prescription drugs, individual states are preempted from imposing conflicting obligations. 85 they may, however, require greater protections for human subject research taking place within their bounda­ ries. 86 several states have already passed laws regulating human subject 78. see s. matthew liao et al., the duty to disclose adverse clinical trial results, 9 am. j. bioetidcs 24, 24 (2009) (discussing the general harm of disclosing adverse clinical results). 79. see id (developing arguments for "a moral duty to disclose all relevant adverse clinical trial results that involve harms to prospective participants in clinical trials"). 80. id at27. 81. ld. 82. /d. 83. carl h. coleman, research with decisionally incapacitated human subjects: an argument for a systemic approach to risk-benefit assessment, 831nd. l.j. 743, 757 (2008). 84. see s. matthew liao et al., the duty to disclose adverse clinical trial results, 9 am. j. of bioetidcs 24, 27 (2009). 85. see coleman, supra note 83 (describing the cuirent system of regulation). 86. id at 760. 20 indiana health law review [vol. 9:1 research occurring within their borders, regardless of funding source.87 while it would be possible for congress to pre-empt state regulation and extend similar protections, so far this has not happened. 88 however, when confronted with harm to research subjects, states can and do apply common law tort and contracts remedies to compensate the injured. 89 physical harm to subjects is actionable under either criminal or tort law. notwithstanding, so far there are no recorded cases of a state mak­ ing a criminal referral90 it was congress's choice at the time to regulate only human subject research funded by the government and not to extend protection to all hu­ man subjects of research regardless of how the research was funded. 91 this choice set up the fragmented system in which federally funded research, which is intended to support a petition to the fda, is regulated differently than all other human subject research, if there is any regulation at all. the current legal structure regulating human subject research supported by fed­ eral funds was passed into law in 1981 and incorporates the national re­ search act of 1974, the 1976 senate hearings and the statement of defmitions and ethical principles set out by the national commission for the protection of human subjects of biomedical and behavior research in what is known commonly as the "belmont report.'m the belmont report 87. see grimes v. kennedy krieger inst., inc., 782 a.2d 807 (2001). the maryland court of appeals held that in this instance, summary judgment was not appropriate to deter­ mine whether the kennedy-krieger institute, a johns hopkins affiliated research organiza­ tion, violated maryland tort law and contract law. !d. at 813. because the researchers had a special relationship with the research subjects, the court stated that there is a heightened duty, which was breached by giving inadequate informed consent. !d. at 846. additionally the consent forms omitted material information. id. at 844. see generally paul litton, non­ beneficial pediatric research and the best interests standard: a legal and ethic reconcili­ ation, 8 yale j. health pol'y, l. & etiiics 359, 378-82 (2008) (describing the litigation); l. h. glantz, nontherapeutic research with children: grimes v. kennedy krieger institute, 92 am. j. pub. health 1070, 1070-73 (2002); anna c. mastroianni & jeffrey p. kahn, risk and responsibility: ethics, grimes v. kennedy krieger, and public health research involving children, 92 a.t\1. j. pub. health 1073, 1073-76 (2002). 88. "today almost every state has whistleblower statutes, and virtually all environ­ mental bills contain whistleblower provisions. they may be exercised in both the public and the private sectors." dawn r. franklin, the outsiders: broadening the scope of standing in whistleblower actions in light of anderson v. united states department of labor, 20 j. nat. resources & envtl. l. 281, 281 (2006). 89. jay m. zitter, annotation, recovery for nonconsensual human medical experi­ mentation, 42 a.l.r. fed. 301 (2009). 90. see l. song richardson, when human experimentation is criminal, 99 j. crim. l. & criminology 89, 98, 107 (2009), who criticizes the reluctance to seek criminal penal­ ties against researchers who cause the harm of subjects either without adequate informed consent or in ways that make consent irrelevant. (''punishing culpable researchers would send a clear message: violations of autonomy and dignity are wrong whether or not they take place in the context of socially beneficial research."). 91. 42 u.s.c. § 289 (2011). 92. jesse a. goldner, regulating conflicts of interest in research: the paper tiger needs real teeth, 53 st. louis u. l.j. 1211, 1215-17 (2009). 2012] whistleblower protection for medical researchers 21 outlined the ethical principles by which human subject research should be govemed.93 this included familiar references to the helsinki accord such as respect for persons and the necessity for informed consent.94 e. how fda oversees clinical trials every drug sold in the united states must first be approved by the fda's center for drug evaluation and research (cder). the approval process involves filing an application for a new drug.95 the company seek­ ing approval (the sponsor) must submit the human and animal clinical trials on which it is basing its representation that the drug being offered is both safe and effective. the fda's ability to oversee the safety of humans in drug trials comes from its authority to require the submission of study re­ sults.96 research for every drug that eventually reaches the american public starts with a scientist's idea and proceeds through a series of testing phases until the fda is convinced that it is both safe and effective. it is described as non-therapeutic research because this initial testing is usually done on healthy volunteers who do not suffer from the conditions the drug being tested is designed to treat.97 human subject research intended to support an application for sale of a new drug in the united states is regulated differently from human subject research funded by the federal government intended to increase the general fund of knowledge. the fda requires those conducting clinical trials to follow good clinical practices (gcp), which are similar, but not identical to ohrp's requirements for federally funded human subject research.98 both activities come with inherent, if different, conflicts of interest. although both the office of human research protection and the fda have the statutory authority to over-see research trials, both are under93. jacqueline fox, reinvigorating the concept of benefit: the failure of drug company-sponsored research on human subjects, 38 seton hall l. rev. 605, 606 (2008). 94. the way bioethicists have influenced the law of human subject research is appar­ ent in reviewing how the human subject research regulations have evolved since 1974. carl h. coleman et al., the ethics and regulation of research with human subjects 723 (2003). 95. 31 c.f.r § 314 (1998)(requirements for :filing anew drug application). 96. coleman et al., supra note 94. 97. douglas a. grimm, informed consent for all! no exceptions, 31 n.m. l. rev. 39. 53 (2007) (explaining that for most analytical or evaluative purposes. human subject research is divided into two categories: therapeutic and non-therapeutic). 98. for an overview of these differences see comparison of fda and hhs human subject protection regulations. u.s. food & drug admin .• http://www.fda.gov/ sciencere­ searcb/specialtopics/runningclinicaltrialsieducationalmaterials/ucmll2910.htm (last updated mar. 10. 2009). see generally j. tori evans. clinical trial data bank: the missing link in the dissemination of information to the medical community. 9 qulnnipiac health l.j. 69, 73-76 (2005) (a history of how the fda developed into its present day role of evaluating the safety and efficacy of prescription drugs). 22 indiana health law review [vol. 9:1 funded and stretched thin. . critics adile shamoo and paul gelsinger note that, "last year, a report by the [i]nspector [g]eneral of the department of health and human services found that the fda, the agency responsible for overseeing most clinical trials, inspected just 1 percent of study sites."99 these inadequacies and gaps are compounded in the area of drug research, development, and sales because even when laws exist to encourage disclo­ sure, they .are often predicated on reporting specific violations of the law. since research itself is so inconsistently regulated, a danger to the public's health may well not violate any existing statute or regulation and therefore the person reporting it would not be eligible for whistleblower protection under any law now in effect anywhere in the country. f dangers arise in all the four phases of fda regulation 1. phase one and two: non-therapeutic research the fda pursuant to its rule making authority establishes these stages of testing. the first time a potential drug can be tested on human is in phase one studies, which the fda describes as being typically "designed to determine the metabolism and pharmacologic actions of the drug in hu­ mans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. "100 since the purpose of a phase one trial is to test the toxicity of a drug, the dangers to research subjects may be considerable. until a series of scandals in the late 1970s put an end to the practice, most phase one testing in the united states was conducted on prisoners.101 without access to prisoners, researchers looked for other large groups of healthy adults with plenty of time on their hands and discovered college students102 and homeless people. 103 today, phase one trials are primarily conducted by pharmaceutical companies in standalone research facilities 99. paul gelsinger & adil e. shamoo, eight years after jesse's death, are human research subjects any safer?, hastings center report, apr. 2008, at 25-27, available at http:/ !humansubjects.energy.gov/newslarticles/04002008.eighty ears_ ac.pdf. 100. 21 c.f.r. § 312.21(a)(2008). 101. coleman et al., supra note 94. for a history of the scandals which led to prison­ ers being no longer available as human subjects in phase one drug trials, see allen hornblum, acres of skin: human experiments at holmesburg prison (1999); see also keramet reiter, experimentation on prisoners; persistent dilemmas in rights and regula­ tions, 97 calif. l. rev. 501 (2009). l 02. see generally heather munro prescott, using the student body: college and uni­ versity students as research subjects in the united states during the twentieth century, 57 j. htst. med. & allied sci. 3 (2002). college students have long been a source of human research subjects conducted in universities. the distinction is in their specific recruitment for phase one and two trials conducted by phannaceutical companies. 103. tom i. beauchamp et al., pharmaceutical research involving the homeless, 27 j. med. & pml. 547, 547-64 (2002) (detailing increased use of the homeless in medical re­ search and considering ethical concerns about coercion in obtaining informed consent). 2012] whistleblower. protection for. medical researchers 23 located near universities, which provide large numbers of healthy subjects willing to endure some discomfort and inconvenience in exchange for cash. these centers advertise heavily, promising high pay for little effort. in times of economic hardship, the pool of potential subjects widens beyond college students to include unemployed adults with no other way of making a living. for many, being subjects in phase one medical research has become a way of life. they self-identify as "guinea pigs" and have their own web­ site in which they rate different companies' research facilities and share their experiences.104 writing about the phenomena of"guinea pigging" in the new yorker, carl elliott explains, "[u]nlike subjects in later-stage clini­ cal trials, who are usually sick and might enroll in a study to gain access to a new drug, people in healthy-volunteer studies cannot ejq>eet any therapeu· tic benefit to balance the risks they take."105 one experienced guinea pig­ ger emphasized that this was a commercial transaction, not a contribution to society stating, "[n]obody's doing this out of the goodness of their heart."106 2. phase three and four: therapeutic research unlike phase one and two trials, which are done using healthy volun­ teers, phase three and four trials are called therapeutic research because they are conducted with sick volunteers. it too takes place in stages. if a drug is found safe, then the company moves on to phase two trials which, according to fda regulation, ''includes ... controlled clinical studies con­ ducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to de­ termine the common short-term side effects and risks associated with the 104. guinea pig zero: a journal for human research subjects, http://www.guineapigzero.com/ (last updated may 23, 2008). in 2002, selections from the website were compiled into a book. guinea pig zero edited by robert helms. see guinea pig zero: an anmolooy of tile journal for human research subjects (robert helms ed.,2002). 105. carl elliott, guinea-pigging, the new yorker (jan. 7, 2008), http://www. newyorker.com/reporting/2008/01/07/0801 07fa _fact_ elliott#ixzzovysedrcy. 106. ld writing in guinea pig zero, another man explained that he was "once paid fifteen hundred dollars in exchange for three days and two g.l endoscopies at temple uni­ versity, where he was given a private room with a television. 'it was like a hotel,' he says, 'except that twice they came in and stuck a tube down my nose.'" id another described a two-week study for which he received 1500 dollars as a way of funding his backpacking trip across the country. he writes, it's great: you get a simple physical, a place to stay, fed at least once a day, an opportunity to catch up on tv shows, and the whole time you are getting paid. the price? surrender your freedom. you give a lot of blood. pussies to the needle need not apply. guinea pig zero: an anmolooy of nm journal for human research subjects 34, (robert helms ed., 2002). 24 indiana health law review [vol. 9:1 drug."107 all patients in phase two trials are in need of treatment for a spe­ cific condition. however, their interest in enrolling in a clinical trial varies considerably depending on the nature of their illness. for people who lack medical insurance yet suffer from conditions that are distressing but not life threatening, a clinical trial may be their only way of getting treatment.108 for them, too, the decision to enter a research study is financial. explaining his decision to enroll in an insomnia study, a man without insurance explained, "i saw an ad that had to do with insomnia. i didn't have medical insurance at the time so it's not like i could go see a doctor because it really wasn't cost effective with prescription drugs . . . . and i figured, well, the drug's not proven yet, but i just rolled the dice."109 there are other even more vulnerable participants in phase three tri­ als, who are not seeking care they cannot afford, but rather have serious and life threatening conditions and are seeking treatments which would be una­ vailable to them outside of a clinical trial. they, too, may hope and expect to benefit from the possibility of access to drugs otherwise not available to them.uo the third category of participants in phase three trials are also quite vulnerable because they are so sick that they have very little hope or expec­ tation that they themselves will be helped by the drug they are testing. ra­ ther, they participate in order to help people in the future who suffer from the same condition. in theory, these latter subjects are true altruists who participate in order to help future patients. the vulnerabilities of these subjects have a common feature: they all believe that the research study in which they are participating will improve 107. 21 c.f.r. § 312.21 (2011). 1 08. the ability of terminally ill patients to enroll in a research trial in order to obtain access to experimental drugs has become a topic of considerable interest and dispute. the d.c. circuit held that individuals had no right to access drugs only available through clinical trials. abigail alliance v. von eschenbach, 445 f.3d 470 (d.c. cir. 2007) (en bane), cert. denied, 552 u.s. 1159 (2008); see also elizabeth weeks leonard, the public's right to health: when patient rights threaten the commons, 86 wash. u. l. rev. 1335, 1384 (2009) (arguing that while the supreme court's denial of cert suggests that this will not any time soon be recognized as a fundamental right, professor elizabeth weeks leonard has advanced the theory of a "public health right" which "contemplates that the public, as a body, merits protection from interference by individual members of society. in the case of access to experimental drugs, the potential harm to so many other patients who also await the promise of a cure or benefit from scientific developments, justifies the decision to deny ac­ cess to experimental drugs to currently terminally ill patients."). 109. jill a. fisher, medical research for hire: the political economy of pharmaceutical clinical tr.:ials 135 (rima d. apple & janet golden eds., 2009). 110. grimm, supra note 97, at 57. in fact, almost all subjects in research studies be­ lieve that participation in a study might be of direct benefit. "the purpose of therapeutic research is 'to directly help or aid a patient who is suffering from a health condition the ob­ jective of the research are designed to address.'" grimes v. kennedy krieger inst., inc., 782 a.2d 807, 811 n.2 (md. 2001). 2012] whistleblower protection for medical researchers 25 their health. 111 this is a fundamental mistake since all research is intended to advance knowledge and any benefit to an individual subject is incidental. it is this misconception that the research will help them that is of most in­ terest to ethicists who are far ahead of the law in expressing their concern. while it is certainly true that very sick patients benefit every day from new treatments only available through a research study, the purpose of this study is to assess the effectiveness of the treatment, not treat the research subject. the difference is emphasized in language where the people receiving the experimental treatments are described as subjects, not patients.112 a finding that the new treatment does not, in fact, improve patient outcomes is as much a success as one that finds the opposite. an unsuccessful study is one that provides no conclusive results either way. thus, even studies described as being of "direct-benefit" to the pa­ tients involved, "[a]re~ however, not medical treatment because 'while sub­ jects may receive therapeutic benefits from participating . . . providing direct benefits to subjects is not the purpose of the research.'" fustead, as with all research, the primary goal is to "develop generalized knowledge that may ultimately translate into beneficial treatments for patients in the future."113 "[t]o make the results of a study generalizable, researchers rely on a variety of methodological features that can create risks that do not exist when a person receives individualized medical treatment outside of a study."114 for example, subjects in a therapeutic study may be subject to blood draws, lumbar punctures,115 and other invasive procedures intended to 111. a consistent critic of human subject research is attorney allan milstein, who be­ lieves that patients' hopes for a cure are exploited. see jennifer washburn, informed con­ sent: one lawyer's assault on the medical research establishment, wash. post mag., dec. 30, 2001, available at http://newamerica.net/node/5969. 112. for a powerful literary portrayal of this dichotomy, see margaret edson's play wit, which is told from the perspective a college professor who, faced with an incurable cancer, undergoes a painful trial of an experimental drug without fully understanding that it is of no benefit to her. see carol cohen, margaret edson's witan audience guide (2000), available at http://faculty.smu.edu/tmayo/witguide.htm. 113. /d. 114. coleman, supra note 83, at 751 (emphasis in original) (citing 45 c.f.r. § 46.102(2) (2008)) (defining "research" as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge"); carl h. coleman, duties to subjects in clinical research, 58 v and. l. rev. 387, 396-402 (2005); see also litton, supra note 87, at 362 ("[one} must carefully distin­ guish the purpose of research from the purpose of medical care. medical care aims to pro­ mote an individual patient's well-being. research aims to produce generalizable knowledge."). 115. see coleman, supra note 83, at 751 n.36 ("[ljumbar punctures (spinal taps) ... while usually safe, [are] known to carry a risk of 'serious neurological sequelae."') (quoting a. strachan & j. train, letter to the editor, lumbar puncture and headache: aspirating cerebrospinal fluid speeds up procedure, 316 brit. med. j. 1015, 1018 (1998)); see also litton, supra note 87, at 374-75 (describing a study comparing current treatment of renal disease to experimental therapy, and stating that "[tjhe group receiving the experimental intervention is put at no more risk than the children receiving standard therapy. however, all pediatric participants will be subject to a regimen of blood draws that are not clinically26 indiana health law review [vol. 9:1 gather more data than would be necessary in a purely treatment setting. 116 3. the particular dangers in stages three and four: dangersfrom the therapeutic misconception because stage three and four trials of therapeutic research are con­ ducted with people who are sick, there is inevitably entanglement between the doctor's role as researcher and personal physician. this entanglement leads to a state called the therapeutic misconception [which] arises when re­ search participants confuse the objective of research, which is to generate knowledge, with the objective of therapy, which is to benefit the individual patient. in this situation, some may enroll in studies with the mistaken belief that each study component is aimed at patient care, rather than knowledge production. 117 part of the confusion is because clinical research often takes place in settings such as treatment hospitals and doctors' offices and the medical personnel administering the study are indistinguishable, and indeed often identical to, the people providing treatment. 118 there is a considerable literature that comes to very little agreement of what a researcher's obligations are to a patient as opposed to a physician. 119 indicated; these blood draws are for research purposes only, conducted to monitor changes in the chemical values within the participants' blood, as well as to monitor their compliance with the protocol."). 116. !d. see also peter r. breggin & ginger ross breggin, talking back to prozac: what doctors aren't telling you about today's most controversial drug 42 (1994) (criticizing that the testing of prozac against a placebo made "[the] drug seem more effective than it is" because those who responded to the placebo were dropped and replaced with other subjects. thus, it is impossible to know how many more people actually responded positively to the drug as opposed to the placebo). coleman, supra note 83, at 752 n.37 (citing carl h. coleman et al., the ethics and regulation of' research wrm human subjects 271 (2005) ). the risks of participating in phase two and three trials of new psychiatric medications is even greater than that of other trials because regardless of the potential benefit of the new drug, all subjects must be com­ pletely withdrawn from any other psychiatric medications before starting the trial. this pro­ cess, known as a "washout" is often so dangerous that the subject needs to be hospitalized. even after washout a patient may receive no treatment at all because her regular medications are replaced with a placebo. 117. !d. at 752. 118. rebecca dresser, the ubiquity and utility of the therapeutic misconception, 19 soc. pml. & pol'y 271, 293 (2002) ("[to] erode the therapeutic misconception ... drastic change will be required. first, to counter the pervasive characterization of trials as treat­ ment, researchers must give patients stark, bold, and dramatic signs that research is different from clinical care. simple environmental changes could have a strong impact on patient perceptions. for example, instead of the white coats associated with medical care, investiga­ tors could wear red ones."). 119. see, e.g., coleman, supra note 94; gerald s. schatz, ethical lawyering in the 2012] whistleblower protection for medical researchers 27 this is a particularly difficult problem when both physician and researcher are the same person. traditionally, the discussion starts with the concept of consent.12° federal law requires that all human subjects in federally funded research studies be informed of the risks and benefits they face.121 yet, is being informed the same as having consented? one of the greatest problems faced in protecting human subjects is the inherent vulnerability of all potential subjects regardless of age, education, or legal status, which prevents their ability to withhold freely consent. an­ other is the inherent trust people have in their doctors. as professor rebec­ ca dresser, one of the leading experts in legal and ethical issues concerning human subject research, writes, the ''therapeutic misconception conflicts with the long-standing and widely accepted research ethics principle of re­ spect for persons" because it takes advantages of the trust people already have in doctors as healers. for this reason, everyone, not just specifically identified sub-populations, is vulnerable to when asked to consent to being a research subject.122 it is easy to see why the institutionalized, 123 the cogni­ tively impaired, 124 the young, and the socially marginalized125 need extra protection of human subjects of biomedical and behavioral research, l3 mich. st. u. j. med.&l.151 (2009). 120. see moore v. regents of the univ. of cal., 793 p.2d479 (cal. 1990). the concept of what a patient has or has not consented to in terms of research can often have significant financial implications. almost every first-year law student reads the case of moore v. re­ gents of the univ. of cal., in which the california supretpe court held that a patient did not own the rights to a highly profitable cell line developed fi:om tissue removed from his body during a medically necessary operation. id 121. 21 c.f.r. § 50.20 (2007). 122. dresser, supra note 120. 123. ld. 124. the aging of the united states population and the corresponding rise in rates of dementia has made designing appropriate methods of conducting research with people who lack decision-making capacity a matter of considerable urgency and debate. as professor carl coleman writes, [m]edical research with persons who lack decision-making capacity is in a state of crisis ... [and] in most states, it takes place without any clear regulation. as a result, few, if any, safeguards exist to protect the rights and welfare of incapacitated research subjects, and surrogates who are asked to provide consent on behalf of incapacitated persons have no meaningful standards to help them determine whether they are making the right choice. moreover, the lack of legal authorization for this re­ search means that those responsible for the studies-both the researchers and the surrogates who provide consent-risk substantial liability when, as will inevitably occur, an incapacitated subject suffers injury and a lawsuit results. coleman, supra note 83, at 744. 125. see rebecca dresser, patient advocates in research: new possibilities, new problems,ll wash. u. j.l. &pol'y 237,240 (2003) (citing rebecca dresser, the ubiquity and utility of the therapeutic misconception, 19 soc. phil. & pol'y 271 (2002)) (suggest­ ing that patient advocates in research trials may or may not help avoid the problem of pa­ tients developing "[t]he therapeutic misconception-a phenomenon that occurs when people do not understand the aims and methodological requirements of biomedical research. the primary pwpose of research is to gain knowledge that will improve care for future patients, not to deliver treatment tailored for an individual patient. when research and treatment are 28 indiana health law review [vol. 9:1 protection, but in fact everyone, sick or well, is in a position of relative powerlessness when dealing with respected authority figures such as doc­ tors or researchers. when asked about their experience, research subjects almost universally endorse the belief that the activities of the study are in­ tended for their personal benefit.126 this is, of course, especially true when the subject is sick and is participating in research that may, indeed, be of benefit. even in studies with well people, no type of pre-study consent ma­ terials seems to be sufficient to get subjects to endorse the statement that the study is of no benefit to them whatsoever.127 even if the study does not cause harm its lack ofbenefit is reason for concern because of what profes­ sor richard saver identifies as "intangible harm'' suffered by research sub­ jects who are expecting to be treated. 128 he writes that "[e ]xperimentation activity in the face of near-complete misunderstanding by subjects of what research participation means risks objectifying subjects as mere specimens or pieces of data."129 but, if the researcher and the doctor are the same per­ son, is it possible to have different obligations to the research subject and to the patient, who are also the same person?130 confused, patients may enroll in research studies without a good understanding of the trade­ otis involved. such patients may have an unrealistic hope for personal benefit without rec­ ognizing the risks and uncertainties accompanying their participation in the studies.''). 126. dresser, supra note 27, at 45-46. 127. id. at42. 128. see generally richard s. saver, medical research and intangible harm, 74 u. cin. l. rev. 941 (2006). 129. · id at 945-46, 1000. professor saver explains that while available data suggests that participating in a recent study does not significantly increase an individuals' chances of suffering physical harm or of being put in a worse medical condition than if he or she had not enrolled, [a] research subject faces a range of serious potential hazards that may materialize even if participation in the experiment has not made the sub­ ject therapeutically any worse off than if she had not enrolled. this harm includes not only emotional distress, but also lost opportunity costs, destruction of trust and confidence in the research process, clinical trial abandonment, affi'ont to dignitary interest, breach of confidentiality, invasion of privacy, loss of meaningful choice about use of one's body as an experimental object, participation in a study that fails to dissemi­ nate trial data in order to advance medical knowledge, and frustrated ac­ cess to perceived cutting-edge therapy. id at 945-46. the status of a human research subject is itself a subject of considerable de­ bate. contemporary ethicists and lawyers like richard saver believe that subjects should be seen as ''partners" or "co-adventurer[s]" with the researchers rather than as passive objects of study. i d. at 1007. while there are researchers who conduct studies as joint-ventures, most have not adopted this view and, indeed, see the idea of actively involved subjects as an un­ necessary complication. 130. there are two main points of view. one is most often associated with u.s. law professor fran miller and ethicist dr. howard brody who believe that research and medical care are quite different and therefore the obligations of a researcher are not those of a physi­ cian. see, e.g., franklin g. miller & howard brody, a critique of clinical equipoise: ther­ apeutic mzsconception in the ethics of clinical trials, hastings center report, may-jun. 2003, at 19-28; franklin g. miller, research ethics and misguided moral intuition, 32 j. l. med. & ennes 111, 111-16 (2004). however, canadians paul b. miller and charles wei­ jer step outside this traditional consent based analysis to point out that whether the relation2012] whistleblower protection for medical researchers 29 these activities are, unfortunately, common. in a series of front page articles, the new york times reported in the summer of 2010 that glax­ osmithkline conducted secret tests which confirmed rumors of heart prob­ lems associated with the drug avandia. in a document obtained by the new york times, an executive wrote in a 2001 internal email, "this [the test] was done for the u.s. business, way under the radar . . . . per sr. mgmt request, these data should not see the light of day to anyone outside of [the company]."131 even more disturbing than the company's own efforts to hide the dangers was the cooperation of a prominent physician associated with a respected academic medical center who lent his name to an article support­ ing use of a vandia in medical journals which company records describe as being "ghost-written" for him. 132 in august 2005, a jury in brazoria county, texas, found merck & co., the manufacturer ofvioxx, liable for the death of the plaintiff robert ernst after a six-week trial. the jury concluded that "merck failed to warn doctors of the dangers of vioxx, and that merck's negligence caused the death of ernst, a physically fit tri-athlete who suffered a sudden heart at­ tack."133 interviewed afterwards, the "jurors said they had concluded from the testimony and documents presented by mrs. ernst's lawyers that merck was long aware of vioxx's potential heart risks but hid those risks from patients."134 the costs of suppressed information about potential dangers extend beyond those actually injured by the drugs. it all results in higher prices for consumers of these drugs because of higher research and development costs ship is between doctor and patient or researcher and patient, it is one of "personal trust" in which there is an inherent inequality between the parties which results in "dependence gen­ erated by the voluntary act of entrusting power to another. paul b. miller & charles weijer, trust and exploitation in clinical research, in the limits of consent: a socio-ethical approach to human subject research in medicine 31(0onagh corrigan et al. eds., 2009). they note that this trust relationship creates a "moral obligation" equivalent to the "fiduciary relationship" between an attorney and client. ld. miller and weijer conclude that this inequality, which creates a "distinctive risk of exploitation," creates the same "duty of care" in a researcher as in a physician. id at 36. 131. harris, supra note 5. 132. paul baskin, baylor college of medicine investigates professor over avandia article, chron. higher educ., july 16, 2010, available at http://chronicle.com /article/baylor-college-of-medicine/66308. 133. lanier law firm, http://www.indeed.com/cmp!lanier-law-firm (last visited nov. 20, 2011); see also marc kaufman, merck found liable in vioxx case: texas jury awards widow $253 million, wash. post, aug. 20, 2005, available at http://www.beasleyallen.com/news/merck-found-liable-in-vioxx-case-texas-jury-awards­ widow-253-million/. 134. alex berenson, for merck, paper trail won't go away, n.y. tlmes, aug. 21, 2005, available at http://www.nytimes.com/2005/08/21/business/21vioxx.html. for an ex­ ample of pharmaceutical companies sharing information in order to reduce costs and speed innovation by developing an open data base for researchers in the field of alzheimer's dis­ ease, see melly alazraki, drugmakers agree to share alzheimer's research data in search of breakthrough, daily finance (june 13, 2010, 3:00 pm), http://www. dai­ lyfinance.com/story/drugmakers-agree-to-share-alzheimers-research-data/195131 09/. 30 indiana health law review [vol. 9:1 when failure to publicize negative results leads to expensive duplication of research that has already proved to be a dead-end finally, any costs which impact profit, such as spending development funds on dead-ends, reduce the earnings available to shareholders of the pharmaceutical companies do­ ing the research.135 n. movement of clinical trials overseas although there are guidelines for conducting human subject research, there is no global, legally binding authority to make sure that they, or any other standards, are followed. 136 instead, human subject research is regulat­ ed within the country where it takes place unless the country has voluntarily agreed to follow the standards of an international organization such as the world health organization (wh0)137 or council of international organiza­ tions ofmedical sciences (cioms).138 as one commentator notes, "[t]oday, the greatest obstacle to ensuring the health and safety of participants in overseas trials may be the lack of regulation over the [independent contractors] employed by western phar­ maceutical manufacturers. developing, unstable countries are generally ill­ equipped to oversee, much less manage, the clinical trials being held within their borders."139 what makes matters worse is that even countries that have their own laws may not be able to enforce them.140 135. ethicist dr. haavi morrein emphasizes in her work that it is misleading to con­ tlate the role of the researcher when the subj~ is a healthy volunteer versus a usually very ill patient. haavi morreim, the clinical investigator as fiduciary: discarding a misguided idea, 33 j. l. med. & ethics 586, 594 (2005) ("when research involves healthy, normal volunteers who are capable of looking out for their own interests, the major constraint will be to provide full and honest information, and to ensure risks are acceptable. however, where ill persons seeking help are involved. those duties might be enriched to require special vigilance."). 136. katherine drabiak-syed. state codification of federal regulatory ambiguities in biobanking and genetic research, 30 j. legal men. 299, 319-20 (2009) (describing, in the context of genetic research, the gaps between international standards for human subject re­ search and federal, state and international law). 137. the organization wikileaks reported in december of2009 that representatives of the world's largest pharmaceutical companies had advance access to a who working group report intending to impose restrictions on pharmaceutical company practices. kaitlin mara, big pharma caught spying on the who, wikileaks, http://wikileaks.org/ wiki/big_pharma_canght_spying_on_the_ who (last visited aug. 9, 2010). 138. about us, councn.. for int'l 0rgs. of men. sci., http://www.cioms.ch/ about/ftame_about.htm (last visited dec. 17, 2011). 139. yevgenia shtilman, pharmaceutical drug testing in the former soviet union: contract research organizations tu broker-dealers in an emerging testing ground for america's big phanna, 29 b.c. 1'hird world l.j. 425, 436 (2009). 140. clinical research organizations are stand-alone private companies which conduct clinical trials in the united states and overseas. fdb network. http://www. fdbnet­ work.com/clinical-research-org-cro (last visited nov. 14, 2011 ). they are also described as contract research organizations. biomedical research directory, biores.org, http://www.biores.org/dir/companies/contract _research_ organizations/ (last visited nov. 2012] whistleblower protection for medical researchers because there is no positive international law mandat­ ing that private companies running clinical trials (clinical research organizations) comply with the relevant domestic laws of the clinical studies' spon­ sors, the resulting "regulatory vacuum" makes it diffi­ cult for these countries to ensure the welfare of trial participants and forces them to rely on foreign data and foreign review processes.141 31 because so much research is now done overseas by american compa­ nies and by companies intending to develop products for sale in the united states, there have been many recent proposals to extend u.s. human subject protections to overseas drug trials. there are many reasons why pharma­ ceutical companies are moving clinical trials outside the united states.142 for most pharmaceutical companies, it is an issue of cost and convenience; they are exporting research trials overseas for the same reason sneaker companies are moving factories to asia. 143 while statistics vary by country, today, the large pharmaceutical companies conduct between fifty and sev­ enty percent of phase one and two clinical trials outside of the united states. 144 although congress has given statutory authority to the fda to regulate and inspect drug manufacturing facilities overseas, it does not have authority to oversee drug trials occurring outside the united states. 145 if a drug is developed and tested entirely outside the united states, its manufacturing company need never file an ind with the fda and instead files directly for approval. the fda clinical data is obtained entirely over­ seas and therefore never falls under fda supervision. the fda does not require a sponsor presenting such an application to prove that its clinical 14, 2011). 141. shtilman, supra note 141, at 436. 142. see generally adriana petryna, when experiments travel: clinical trials and the global search for human subjects (2009) (studying the activities of "across­ the-globe-research" (agr), a private company created to fu.cilitate drug trials for pharma­ ceutical companies). 143. see generally finnuala kelleher, the pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations, 38 colum. j.l. & soc. probs. 67 (2004) (reviewing international standards for human subject research). 144. seepetryna,supranote 144, at 13. 145. see e. m. abler, plugging the gatts and wtos: toward a globalized pharma­ ceutical regulatory framework, 29(1) biotechnology l. rep. 3, 12 (2010) (arguing that the fda has the authority to negotiate international agreements and to inspect overseas drug manufacturing plants but has not done so effectively because of lack of enforcement re­ sources); see also 21 u.s.c.a.. § 381 (2011) (empowering the secretary of health and hu­ man services and, by extension, the fda to enforce the same regulatory standards on prescription drug imports as on domestically produced prescription drugs); fda drv. of field investigations, guide to international inspections and travel,§ 302.1 (2002), available at http://www.fda.gov/iceci!inspections!foreignlnspections/ucmll3565.htm# 303.1 ("the intent of the international inspection program is to ensure that products manu­ factured in foreign countries meet the same standards of quality, purity, potency, safety, and efficacy as required of domestic manufu.cturers."). 32 indiana health law review [vol. 9:1 trials were conducted under the same regulations as if they had occurred in the united states. instead the company must file good clinical practice (gcp) guidelines.146 this raises concerns about the extent to which the human subjects were provided with informed consent and had adequate protection against injury. there may be some potential for subjects in studies, which occur overseas, to seek redress in the united states. the second circuit recently upheld the right of nigerian children, who were harmed in a study of the antibiotic trovan, to sue for a study funded by pfizer and conducted in ni­ geria.147 reversing the district court's dismissal of the case on the grounds of forum non conveniens, the second circuit upheld the right of subjects harmed by american companies in the course of human subject research conducted overseas to seek redress in the united states under the alien tort claims act.148 despite the efforts of several organizations, including the fda and the world health organization, to track on-going clinical trials taking place outside the united states, it is difficult to determine exactly how many of these trials are taking place overseas. the world health organization maintains a voluntary international clinical trials registry platform (ictrp), which it describes as "a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous 146. the code of federal regulations provides that, .,an application based solely on foreign clinical data meeting u.s. criteria for marketing approval may be approved if: (1) the foreign data are applicable to the u.s. population and u.s. medical practice; (2) the studies have been performed by clinical investigators of recognized competence; and (3) the data may be considered valid without the need for an on-site inspection by fda or, if fda considers such an inspection to be necessary, fda is able to validate the data through an on­ site inspection or other appropriate means. failure of an application to meet any of these criteria will result in the application not being approvable based on the foreign data alone. fda will apply this policy in a flexible manner according to the nature of the drug and the data being considered." 21 c.p.r.§ 314.106 (2011). 147. for a chronology of these events, see case profile: pfizer lawsuit (re nigeria), bus. & hum. rts. resource centre, http://www.business-humanrights.org/categories/ lawlawsuits/lawsuitsregulatoryaction/lawsuitsselectedcases/pfizerlawsuitrenigeria (last visited nov. 21, 2011). one ofthe pieces of information discovered from a wikileaks re­ lease is that pfizer tried to discredit the nigerian attorney general in an attempt to make him drop the lawsuit. pfizer denies this ever happened. there may be some improvement in the ability of subjects in overseas studies to seek redress in the united states. the second cir­ cuit recently upheld the rights of nigerian children who were harmed in a study funded by pfizer. duff wilson, secret cable discusses pftzer's actions in nigeria case, n.y. times (dec. 10, 2010), http://www.nytimes.com/2010/12/lllbusiness/llpfizer.html (last visited dec. 31, 2010). 148. the u.s. supreme court rejected pfizer's petition for certiorari, adamu v. pfizer, inc., 399 f. supp. 2d 495 (s.d.n.y. 2005), rev'd sub nom. abdullahi v. pfizer, inc., 562 f.3d 163 (2d cir. 2009), cert. denied, 130 s. ct. 3541 (2010), and pfizer has subsequently settled both lawsuits for a reported $75 million. case profile: pfizer lawsuit (re nigeria}, bus. & hum. rts. resource centre, http:/lwww .business-humanrights.org/categories/law lawsuits/lawsuitsregulatoryaction/lawsuitsselectedcases/pfizerlawsuitrenigeria (last updat­ ed feb. 21, 2012). 2012] whistleblower protection for medical researchers 33 identification of trials with a view to enhancing access to information by patients, families, patient groups and others."149 it explains that the reason for having a registry is because: when researchers embark on a clinical trial, they make a commitment to conduct the trial and to report the findings in accordance with basic ethical princi­ ples. this includes preserving the accuracy of the re­ sults and making both positive and negative results publicly available. however, a significant proportion of healthcare research remains unpublished and, even when it is published, some researchers do not make all of their results available. selective reporting, re­ gardless of the reason for it, leads to an incomplete and potentially biased view of the trial and its re­ sults.150 a. the relationship between big pharma151 and academic medical cen­ ters most consumers of medical research are unaware of the extent to which much of the research conducted at academic medical centers is actu­ ally sponsored by private pharmaceutical companies. today, a research study that is described as originating from johns hopkins or harvard may well have been funded, designed, and implemented by the company market­ ing the resulting drug or device. although the early stages of drug testing, in which the subjects are healthy volunteers, are still primarily conducted 149. world healni org., about the who ictrp, http://www.who.int/ictrp/ about/en/ (last visited nov. 21, 2011). see generally carolyne r. hathaway et al., the web of clinical trial registration obligations: have foreign clinical trials been caught?, 64 fooo & drug l.j. 261 (concluding that companies need to comply with many different u.s. and international regulations when conducting a clinical trial overseas). 150. world healrn org., reporting of findings of clinical trials, http://www. who.int/ictrp/results/en! (last visited nov. 21, 2011 ). 151. "big pharma" is a frequently used collective term for the major pharmaceutical companies. ronald j. gilson et al., braiding: the interaction of formal and informal con­ tracting in theory, practice, and doctrine, 110 colum. l. rev. 137, 1405 (2010) ("the pharmaceutical collaboration and licensing agreement between a 'small pharma,' pharmaco­ peia (pharma), and a 'big pharma,' bristol-myers squibb (bms), illustrates the essentials of braiding."). see also katelyn bernier, obviating the obvious? an appraisal of pharmaceu­ tical patents, 10 j. high tech. l. 208, 208 (2010) ("this note addresses the extent of the market for pharmaceutical research and development in the united states and how pharma­ ceutical companies have evolved to meet this demand. it also explains the notable relation­ ship that has developed between the major pharmaceutical companies, collectively known as 'big pharma,' including, but not limited to, major corporations such as pfizer inc., johnson & johnson, and bristol-myers squib, and their generic drug manufacturing competitors like mylan inc., teva pharmaceutical industries ltd. (teva), and sandoz."). 34 indiana health law review [vol. 9:1 by pharmaceutical companies, it is fair to say that any study involving a subject who is already ill is overseen both by employees of pharmaceutical companies and by doctors who work for or are associated with the hospitals which both provide treatment and serve as a site for research. the pharmaceutical industry (''big pharma") has the highest profits of any sector in the u.s. economy. because these companies fund the clinical trials, they wield a substantial influence over how clinieal trials are con­ ducted and how the results are analyzed and distributed.152 this is because once a drug is developed, it costs very little to manufacture. it is the very profitability of the industry that makes it such a powerful force.153 today academic medical centers at many universities are as de­ pendent on pharmaceutical companies as they had ever been on the gov­ ernment. the federal government tends to cluster its research dollars in a small number of institutions. for example, johns hopkins receives eighty percent of all the funds nlll grants for medical research.154 while there has always been a close relationship between the physicians who ran clinical drug trials in their hospitals and the companies who sponsored them, drug companies are increasingly becoming intertwined with the actu3.l operation of these institutions. the institute of medicine reports that a "2006 national survey of department chairs in medical schools and large independent teaching hospitals found that 67 percent of academic departments (as ad152. cono. budget office, research and i>evelopment in the pharmaceutical industry (oct. 2006) 27-28, available at http:/lwww.cbo.gov/ftpdocs/76xx/doc7615/10-02drugr-d.pdf (harvard economics professor greg mankiw explains this is because "[t]he industry's high r&d spending and relatively low manufacturing costs create a cost structure similar to that o~ for example, the software industry. both industries have high fixed costs (for research and development) and low variable costs (to put a software application onto a cd-rom or to produce a bottle of prescription medication). consequently, prices in those industries are usually much higher than the cost of providing an additional unit of the prod­ uct, because revenue from sales of the product must ultimately cover those fixed costs."). see greg mankiw, cbo on phanna profits, greg mankiw's blog (oct. 2, 2006), http://gregmankiw.blogspot.com/2006/l 0/cbo-on-pharma-profits.html. 153. while private companies nmst seek the fda's approval, this oversight comes only in retrospect and only on materials provided to the fda by the company itself. as a result, an unsuccessful trial in which people were in fact injured or even died may never be known if the company chooses not to bring the drug forward for approval. drugs tested at private facilities in the u.s. or, increasingly, overseas are tested with no outside oversight of the process. once a drug is approved, pharmaceutical companies are allowed to engage in marketing practices which are illegal in most other (developed) nations. 154. see generally caroline mcgeough, the research industrial complex: is unbiased research economically feasible?, the chronicle (apr. 22, 2010), http://dukechronicle.com/ article/research-industrial-complex (''in one tower of a nondescript, nine-story white build­ ing on fulton street, just across from duke university hospital, operates the world's largest academic clinical research institute, generating more than $125 million in revenue per year from the research grants and contracts it receives from both government sources and from industry. its more than 218 clients in the pharmaceutical and medical device sectors include corporate giants johnson & johnson, pfizer, glaxosmithkline and ge healthcare. the duke clinical research institute, composed of more than 1,000 employees supporting the worldwide clinical research projects directed by 220 duke faculty."). 2012] whistleblower protection for medical researchers 35 ministrative units) had relationships with [the pharmaceutical] industry .... [, and] [a]mong the department chairs, 60 percent had [personal] relation­ ships with [the pharmaceutical] industry."155 while the federal govermnent's investment in research at universities is still greater than the private industry, pharmaceutical companies are catching up as major sources of funding. 156 there are several reasons why pharmaceutical companies have come to have such a close relationship with universities. in part, their reasons are the same as the government; universi­ ties and their medical centers that have the best resources to conduct clinical trials. pharmaceutical companies today see the same advantages the federal govermnent saw during world war ii. funding research at universities, rather than running their own tests, included the added benefit of using the universities' existing infra-structure and their access to patients. while ear­ ly testing on healthy human subjects can occur at stand-alone facilities owned and operated by the pharmaceutical companies, when drugs need to be tested on sick people, the companies need to go to hospitals.157 but, the pharmaceutical companies' interest in the universities goes beyond the need for human subjects. largely, universities have become federally subsidized think -tanks where scientists conduct research on which future products can be developed. in addition, the pharmaceutical compa­ nies benefit from the prestige doctors in academe who can promote their products by putting their names on articles or serving as speakers.158 final155. institute of medicine of the national academies, conflict of interest in medical research, education, and practice 101 (2009). 156. jeffrey brainard, the top 100 universities in research spending had more in­ dustry help in 2009, chronicle of higher education (sept. 28, 2010), http:/ /chronicle.com/article!the-top-1 00-universities-in/124630/?sid=at&utm _ source91t& utm medium=en. see also paul m. sw amid ass, association of universi1y technology managers licensing activi1y survey (2008), http://www.kauffinan.org/uploadedfiles/ researchandpolicy/entrepreneurshipdata/2008datalassoeiation-of-university-technology­ managers.pdf (citing press release, association of university technology managers, 2007 autm licensing survey shows a statistical progress report in academic technology transfer, available at http://www.autm.net/fy _2007 _licensing_ activity_ survey.htm {not­ ing that in 2007, the industry sponsored 3.4 billion dollars of research in universities)). 157. the pharmaceutical companies' relationship with hospitals extends far beyond those associated with academic medical centers. drug trials are going on in almost every hospital in the country. see protecting human research subjects: statement before the subcomm. on public health and senate committee on health, education, labor, and pen­ sions, 106th cong. (2000) (statement of william a. raub, deputy assistant secretary for science policy, department of health and human services), available at http:/ /www.fda.gov/newsevents/testimony/ucml1494l.htm. 158. many critics believe the risk to the university's prestige and credibility is not worth the funding from pharmaceutical companies. see bryan a. liang & tim mackey, confronting conflict: addressing institutional conflicts of interest in academic medical centers, 36 am. j. l. & med. 136, 138 (2010) ("industry involvement and support of amcs [academic medical centers] may nevertheless be acceptable if conducted in an appropriate manner. however, industry relationships with amcs that give rise to conflicts of interest pose a significant concern and challenge to amcs. those relationships have the potential to compromise the integrity of an institution and undermine the public's trust in the medical 36 indiana health law review [vol. 9:1 ly, the pharmaceutical companies benefit when research they fund results in changes to clinical practice, which draws in more potential consumers for the products they already sell. another factor in building the relationship between academic medi­ cine and the pharmaceutical companies is the existing close ties between physicians and the pharmaceutical companies.159 writing in the new eng­ land journal of medicine, dr. david blumenthal reviews the effect of this marketing on practicing physicians citing studies which "found that a wide variety of interactions-meetings with company representatives; the receipt of gifts, free drug samples, and free meals; company support for travel to and lodging at educational events; attendance at lectures by representatives of pharmaceutical companies; acceptance of honoraria; and other relation­ ships-were associated with changes in physicians' use ofmedications."160 but the kind of influence considered in this article takes place not in indi­ vidual doctors' offices but in the academic medical centers where they do research and teach. 161 ed, considering the issue in a 2009 report, the institute of medicine statit is critical that the public trust that research institu­ tions are protecting the integrity of the medical re­ search on which clinical practice and education depend. such protection is especially important in clinical research because bias in the design, conduct, or reporting of the findings of such research may ex­ pose human participants to risks . . . and may ultiand research community."). 159. david blumenthal, doctors and drug companies, 351 new eng. j. med. 1885 (2004), available at http://www.nejm.org/doilfull/10.1056/nejmhpr042734 ("[i]nteractions between drug companies and doctors are pervasive. relationships begin in medical school, continue during residency training, and persist throughout physicians' careers. the perva­ siveness of these interactions results in part from a huge investment by the pharmaceutical industry in marketing [directly to doctors]."). 160. /d. 161. the extent of the industry's direct involvement in academic medicine has raised concerns significant concern. many commentators have criticized this practice, both in terms of disclosure and in terms of the effect outside funding has on the integrity of individ­ ual researchers. thomas stossel is one of these highly critical medical school professors. he writes, [r)esearch is not done for free. to fund their work, university investiga­ tors obey the whims of nonprofit as well as commercial sponsors. uni­ versity and governmental rules that prevent wide-ranging interactions between academic researchers and industry limit creative and economic opportunities and are a far greater violation of academic freedom than any documented interference by industry. thomas p. stossel, regulating academic-industrial research relationships-solving prob­ lems or stifling progress?, 353 new eng. j. med. 1060, 1063 (2005). see also janet l. dolgin, debating conflicts: medicine, commerce, and contrasting ethical orders, 35 hofstral. rev. 705, 724 n.llo (2006). 2012] whistleblower protection for medical researchers mately expose much larger numbers of patients to in­ effective or unsafe clinical care. 162 1. evidence of academic medicine's financial entanglement with big pharma: ghost writing and secret payments to medical academics 37 research that changes the standard of practice rather than produces a new drug c~ also create serious dangers. the most serious allegations were made by the senate committee on finance, chaired by iowa's senator charles grassley, against both medical researchers and pharmaceutical companies, that the companies secretly-funded research intending to change standards of care. when clinical care guidelines are changed based on the findings of a study published in a respected peer-reviewed journal, doctors begin pre­ scribing medication for patients who previously would not have been taking anything. a 2009 article in the boston globe reported that "[v]irtually all the psychiatrists who wrote the latest clinical guidelines for how to treat depression, bipolar disorder, and schizophrenia had financial ties to drug companies."163 similarly, the new england journal of medicine cites re­ search suggesting that "[a ]s many as 59 percent of the authors of clinical guidelines endorsed by many professional associations have had financial relationships with companies whose drugs might be affected by those guidelines."164 ghostwriting is the practice of researchers accepting payments from pharmaceutical companies to allow the use of their names as authors on articles they did not write.165 ghostwriting is a particularly dangerous ex­ ample of how conflicts of interest harm the public's interest. there is no regulation of the peer review journal system through which practicing phy­ sicians (clinicians) learn of recommendations to change their treatment plans based on new evidence from what they believe to be disinterested sci­ entific studies. by influencing the result of a study which changes the pre­ scribing practices of thousands of physicians, pharmaceutical companies can greatly expand the sale of drugs already on the market.166 a series of 162. conflict of interest in medical research, education, and practice 117 (bernard lo & marilyn j. field eds., 2009). 163. carey goldberg. firms tied to some mds who set policy, boston globe (apr. 2, 2009), http:/ lwww.boston.com/newsllocal/massachusetts/articles/2009/04/02/firms _tied_ to some_mds_ who _set _policy/. 164. david blumenthal, doctors and drug companies, 351 new eng. j. med. 1885 (2004). 165. see staff of s. comm. on fin., 111 th cong., minority staff rep. on ghostwriting in medical literature (comm. print 2010) (sen. charles e. grassley, ranking member), available at http://www.grassley.senate.gov/aboutlupload/senator-grassley-report.pdf. 166. for an account of how hormone therapy became first the standard of care for post­ menopausal women to prevent breast cancer, heart disease, and osteoporosis and was then discredited as actually increasing the rates of these diseases, see carl eluott, wmte coat, 38 indiana health law review [vol. 9:1 articles in the new york times revealed that several of the largest pharma­ ceutical companies had been paying prominent medical academics to put their names on studies whose results they had not themselves analyzed. 167 although this practice is described, as "ghostwriting," it is no mere matter of polishing grammar and style. rather,. the pharmaceutical company, not the author with academic medical credentials, conducts the analysis of the data acquired at many different clinical trial sites and draws the conclusions which form the basis for the article.168 announcing a $56 million multi-state settlement over its deceptive practices in keeping the dangers of vioxx from the public, pennsylvania's attorney general noted that merck would no longer engage in ghostwriting, explaining that "[g]hostwriting can be a particularly deceptive practice. some of these articles looked as though they were being published by an independent doctor or organization, but they were allegedly written by peo­ ple who worked for, or had some sort of interest, in merck."169 one of the barriers to regulating the safety of people involved in clini­ cal drug trials is that these trials are paid for and conducted by private drug companies. u.s. law gives drug companies a lengthy monopoly on the sale of new products in order to justify the cost of research and development. this protection of intellectual property is a wise inducement to create and explore, and our "innovation economy'' depends upon sufficient protection of intellectual capital. what americans should demand in return for this protection is that the fda be able to make an honest evaluation of the effi­ cacy of drugs.170 the majority of studies intended to produce a drug for human use are funded by the pharmaceutical companies that will directly benefit from the drug's sale. 171 federal law requires that every institution receiving federal funding for human subject research screen each proposal to assure the safety of the participants. this is done through an internal review board (irb) made up of both employees of the institution and representatives of outside inter­ ests.172 the irb reviews every single application for research and monitors black hat: aoveniures on the dark sidb of medicinb 81-84 (20 10). 167. natasha singer, medical papers by ghostwriters pushed therapy, n.y. times, aug. 4, 2009, at ai, available at http://www.nytimes.com/2009/08/05/health/research/ 05ghosthtml. 168. /d. ("the court documents provide a detailed paper trail showing how wyeth con­ tracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing.''). 169. press release, office ofpa. att'y gen., attorney general corbett announces a multi-state, $58 million settlement with merck over deceptive advertising concerning the safety of vioxx (may 20, 2008), available at http://www.attomeygeneral.gov/press. aspx?id=3660. 170. spitzer, supra note 4. 171. at least thirty percent of human subject research studies in the united states are n(>t regulated by the federal or state government. see marcia angell, thb truth about the drug companies: how they i>bceive us and what to do about it 75 (2004). 172. 45 c.f .r. § 46.107 (2011 )(regulations governing the composition of irbs). 2012] whistleblower pr.o'ieci'ion for medical researchers 39 the research by requiring submission of adverse events reports should a sub­ ject be harmed.173 too much scrutiny by an irb may result in a pharma­ ceutical company moving its trials to a more cooperative venue. therefore, the temptation to put profit before safety by not alienating funding sponsors is intense.174 writing about the pressures to over-state positive results and suppress negative research results, professor rebecca dresser identifies "[t]ruthful disclosure"175 as "a fundamental moral principle for scientists."176 she identifies "[t]he moral principle of respect for persons" as ''under[lying] professional responsibilities to communicate truthfully about research."177 however, this principle is challenged when those funding the research seek to suppress or mischaracterize information. in describing the intangible harms of research, law professor richard saver states that failure to disclose research results does more than harm the public at large; it causes harm to the subjects themselves because it deprives them of "a reasonable expecta­ tion ... that the experiment they participate in will contribute to improving the state of medical knowledge."178 he argues that suppressing the results is "an affront to the subject's human dignity''179 because ''withholding of trial data treats subjects no better than discarded specimens of a botched experiment. "180 b. post-market protection: dangers to consumers after a drug is ap­ proved once a drug is approved for sale in the united states, it is the task of the company which developed and manufactured it to go out and sell it to the only people who can make it available to patients: physicians. while the fda has statutory authority to oversee the safety of drugs once they are on the market, its efforts are prii:narily targeted at inspecting the manufac173. see continuing review after study approval information sheet: guidance for institutional review boards and clinical investigators, fda.gov, http://www.fda.gov/ reg­ ulatorylnformation!guidances/ucm126424.htm (last updated oct. 18, 2010). 174. see generally simon de lusignan et al., the roles of policy and professionalism in the protection of processed clinical data: a literature review, 16 int'l j. med. informatics 261 (2007); leonard h. glantz, nontherapeulic research with children: grimes v kennedy krieger institute, 92 am. j. pub. healm 1070 (2002); mastroianni & kahn, supra note 87, at 1073; jacqueline sayers, clinical trial registries: a survey of pa­ tient advocate group perceptions, 43 drug info. j. 195 (2007). 175. rebecca dresser, when science. offers salvation, patient advocacy & research emtes 139 (2001 ). 176. id. 177. id. at 140. 178. richards. saver, medical research and intongible harm, 14 u. on. l. rev. 941, 1007 (2006). 179. id. at 952. 180. id. at 1008. 40 indiana health law review [vol. 9:1 turing process, not looking for hidden dangers. 181 as the system is now, it relies on complaints by physicians and patients, as well as self-reporting by the manufacturer in order to make the public aware of dangers which may emerge after the testing period. several factors make this a very difficult and inefficient process. first, there is no easily accessible single source for tracking the interactions between an individual patient and the health care system. because medical care in the united states is not overseen by any central governing body, it can take a long time for a pattern of bad out­ comes to be traced back to a particular drug. 1. post-market reporting the problem is that while companies are required to report problems to the fda, those in the best position to know of these problems, doctors, are not required to report them, nor is there any systematic method in place to track patients taking newly approved drugs.182 section 506(b) of the federal food, drug, and cosmetic act requires those receiving permission to market a drug in the united states (sponsors) to make yearly post­ marketing reports to the fda about potential dangers to consumers.183 even though the manufacturers of a drug are under a continuing legal obli­ gation to report known adverse effects which develop after a drug is re­ leased, there is no effective way of knowing whether they have done so or not.js4 often, when a drug has been submitted for fda approval, it has been 181. see david a. kessler & david c. vladeck, a critical examination of the fda's efforts to preempt failure-to-warn claims, 96 geo. l.j. 461, 484 (2008) (''there is much work to be done to shore up the agency's ability to detect adverse reactions and to take prompt and effective measures once previously unidentified risks surface."). 182. see brian l. strom & kenneth l. melmon, can postmarketing surveillance help to effect optimal drug therapy?, 242 jama 2420 (1979) ("if used systematically, pms can substantially improve drug therapy in the united states. this can be accomplished by generating information on drug use and effects otherwise unavailable, by enabling a more efficient drug approval process, and by educating drug prescribers. however, to be success­ ful, any pms system will need a good deal of input from such prescribers."). 183. the fda explains these requirements to the public in a faq portion of its web­ site. see postmarket requirements and commitments: frequently asked questions (faq), food and drug administration, http://www.fda.gov/drugs/guidancecomplianceregulatory information!post-marketingphaseivcommitments/ucm070766.htm (last visited nov. 13, 2011) ("section 130(a) of title i of the food and drug administration section 130(a) of title i of the food and drug administration modernization act of 1997 ('the modernization act') became law on november 21, 1997, and added section 506b (reports ofpostmarket­ ing studies) to the federal food, drug, and cosmetic act ('the act') (21 u.s.c. 356b). this provision requires sponsors to report to fda annually on the progress of postmarketing study commitments and for fda to make certain information available to the public."). 184. see jessamyn s. bemiker, spontaneous reporting systems: achieving less spon­ taneity and more reporting, leda at harvard law school, http://leda.law.harvard.edu/ leda/data/363/bemiker.html (last visited mar. 3, 2012). 2012] whistleblower protectlon for medical researchers 41 tested for a very short time on very few people. 185 as a result, little is known about potential dangers from the drug to a large population of pa­ tients who may take it for months, years, or decades.· the harm this causes was highlighted in a lawsuit filed against olaxosmithklein by the state of new york. while the company did not adntit or deny liability, it "agreed to pay $2.5 million in damages and publicly disclose information on all clini­ cal studies in the future."186 the short testing period is troubling when the drug is intended to treat an acute, isolated, medical event, such as an infection or on-going heart at­ tack. the fact is that many of the drugs are intended for sufferers of chronic conditions who may take them for dozens of years. as one critic explains, [t]he only way to calculate the long-term effects of certain products is to try them out on mass markets. this history teaches that those effects do not manifest themselves all at once in neat packages. another les­ son is that the measurement of these effects depends on many variables, not all of which will be classified and analyzed at the same time. thus, even sophisti­ cated scientists dealing with a very large group of people may not think, initially, to focus on subclasses of that group as defined by such characteristics as age, which may appear obvious in retrospect.187 185. rebecca dresser & joel frader, off-label prescribing: a call for heightened professional and government oversight, 37 j.l. med. & ennes 476, 482 (2009) ("the fda has accepted the results of trials involving as few as eight people as adequate evidence of safety and effectiveness.''). 186. for an account of the allegations and what is publically known of the settlement, see benjamin falit, the path to cheaper and safer drugs: revamping the pharmaceutical industry in light ofgiaxosmithkline's settlement, 33 j.l. med. & ennes 174 {2005). 187. marshalls. shapo, experimenting with the consumer: the mass testing of risky products on the american pubue 182-83 (2009). the american medical as­ sociation agrees. its council on ethics and judicial affil.irs ("ceja") reported that doctors needed to participate in reporting adverse events because, although new drugs and devices are not approved for marketing until numerous studies have been completed, premarketing studies cannot guarantee product safety. such studies are limited by the small numbers of patients involved and by the populations being studied. rarely are more than 3000 patients involved in preapproval clinical studies of drugs, and rarely do studies last more than 3 years. any uncommon side effects, delayed effects. or consequences of long-term drug administra­ tion would not be observed before the drug is marketed. additionally, the patient population used in clinical trials does not usually include vul­ nerable populations such as the elderly, the young. women, those with complicated disease, or those taking other medications. information about interactions with these special populations, then, will likely not be revealed in prejl¥u'keting studies but will only become available after the 42 indiana health law review [vol. 9:1 after approval, the number grows larger as it encompasses all of the people to whom the drug is eventually prescribed. while many of these drugs188 are life sustaining, recent estimates suggest that millions of ameri­ cans every year are injured as a result of harm caused directly by a prescrip­ tion drug.189 it is in the drug companies' interest to market a newly approved drug as widely as possible to start recouping the costs of research and develop­ ment. moreover, there are strong incentives to encourage physicians to pre­ scribe new drugs for uses beyond those approved by the fda based on the research data presented by the pharmaceutical company.190 the drug is be­ ing given to patients to treat conditions beyond those indicated on the fda­ approved label, 191 off-labeling, but the physician need never certify why any individual patient's condition warrants any particular prescription med­ ication. once the fda approves a prescription drug or medical device for sale in the united states, every patient for whom it is prescribed becomes an unwitting and unwilling enrollee in a large-scale, open market human trial. although manufacturers are required to collect reports of adverse events, doctors are not required to make them. it is common for problems new product is on the market. am. med. ass'n, reporting adverse drug and medical device events, 4 food & dr.uo l.j. 359 (1994), available at http:/lwww.ama-assn.org/resourcesldoc/ethics/ ceja ..:_ ba93.pdf. 188. the fda defines a ''new drug" as follows: "(1) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific train­ ing and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof, ex­ cept that such a drug not so recognized shall not be deemed to be a ''new drug" if at any time prior to the enactment of this act [on june 25, 1938,] it was subject to the food and drugs act of june 30, 1906, as amended, and if at such time its labeling contained the same repre­ sentations concerning the conditions of its use; or (2) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions." 21 u.s.c.a. § 321(p) (2011). 189. katherine harmon, prescription drug deaths increase dramatically, sci. am., apr. 6, 2010, available at http:llwww.scientificamerican.com/article.cfm?id=prescription­ drug-deaths (noting a sixty-five percent increase in hospitalizations due to prescription drug overdose, the article explains that this might represent a substantial undercount since "[s]ome prescription drug-related hospitalizations might be classified under other primary categories, and those who abuse the drugs were not always labeled as having been poisoned. additionally, the researchers explained, many common terms such as overdcse, misuse and abuse are not well standardized in hospitals''). there are, of course, many different ways in which the consumption of prescrip­ tion drugs can cause death, mcluding deliberate abuse, misunderstanding of dosage instruc­ tions by the patient, mistakes by the prescribing doctor, and mistakes by pharmacists. 190. seedresser&frader,supranote l88,at470. 191. /d. at 476 (''in the existing regulatory framework, once the fda approves a prod­ uct for marketing, physicians may prescribe it for indications or patient populations not in­ cluded on the label. they may also prescribe drugs at dosages or using methods of administration not specified on the label. j. 2012] whistleblower protection for medical researchers 43 to remain unknown until brought to attention by a lawsuit. ghostwriting, off-label prescribing, and direct-to-consumer advertising compound these problems. 2. features of current system which increase post-approval dam­ ages: how pharmaceutical company's practice of ghost writing affects the sale and marketing of drugs after approval because there are rarely any restrictions on how a physician uses a new drug, there are many opportunities for pharmaceutical companies to increase sales by directly marketing to physicians. this takes many forms. articles authored by respected academic physicians play an important part in the marketing and sale of drugs. rather than ask a practicing physician to take their word on the effectiveness of a new drug, pharmaceutical repre­ sentatives often distribute articles published in peer-reviewed medical jour­ nals. sometimes the articles report the results of studies which suggest changes to clinical practices. other times they report on new uses for drugs already approved by the fda for another purpose. as discussed infra, the latter practice would be illegal if it were the drug company itself suggesting an off-label use.192 in both cases, the influence these articles have on physicians is due to the fact that they are authored by prestigious, independent experts in the field and have been reviewed by other independent experts before being published by a medical journal. the discovery that these articles were, in fact, often written by the drug companies themselves and presented to the highly compensated academic authors for their signatures has resulted in considerable damage to the trust between physicians and the pharmaceutical companies which they had seen as their friends. section n outlined the financial dependence of academic medicine on the pharmaceutical industry. one aspect of this is the reliance on income from drug trials which is why academic medical centers were eager to host clinical trials and were, therefore, interested in remaining on good terms with their sponsors. the influence is just as strong, however, when the clin­ ical trials are over, and the drug companies are marketing their new drug. this is because the same physicians whose institutions hosted the trials are also in a position to promote a specific product directly through talks given to other doctors and much more broadly by putting their names to articles which change clinical standards and therefore increase the need for a specif­ ic drug. this can either be done by visits from pharmaceutical representa­ tives known as detailing or more directly by physicians talking to their peers at pharmaceutical company-sponsored conferences.193 the details of 192. dresser & frader, supra note 188, at 476-77. 193. for a highly critical account of the process in which doctors are influenced by 44 indiana health law review [vol. 9:1 the extent of both of these activities have been coming to light through the hearings conducted by the senate finance committee, chaired by senator charles grassley of iowa, 194 who is conducting an on-going investigation of conflicts of interest between physicians and pharmaceutical companies. 195 to prevent situations in which doctors are directly paid by or hold shares in pharmaceutical industries, the late senator edward kennedy and senator grassley proposed the physician payments sunshine act of 2009 that would "provide for transparency in the relationship between physicians and [applicable] manufacturers" with respect to payments and other trans­ fers of value and physician ownership or investment interests in manufac­ turers.196 pharmaceutical companies and how, in tum, these doctors influence other doctors, see eluott,supranote 168, at51-73, 75-108. 194. committee assignments, senator chuck grassley of iowa, http://www.grassley. senate.gov/about/committee-assigmnents.cfin oast visited march 3, 2012). 195. for a description of these conflicts and how they are managed under existing regulations, see goldner, supra note 92, at 1211. 196. this is especially prevalent in the field of medical devices, where surgeons often own an interest in a device, which they themselves then use in or on their patients. essen­ tially, they are in the position ofboth buyer and seller with payment coming, usually, from the federal government through medicare. physician payments sunshine act of 2009: hear­ ing on s. 301 before the s. comm. on fin., 111th cong. (2009) (statement of sen. charles grassley). while the conflicts of interest that arise in medical research are much discussed, resolving them is a complex task. law professor and physician william sage suggests that the problem comes from considering research conflicts of interest in terms of traditional doctor/patient relationships. instead, he suggests that research be considered an act of socie­ tal good and therefore be regulated according to the researcher's obligations to society, not to an individual subject. see william m. sage, some principles require principals: why banning "conflicts of interest" won't solve incentive problem in biomedical research, 85 tex. l. rev. 1413 (2007). the bill did not advance further than referral to the committee on finance. an­ other, far more widespread, form of conflict of interest comes from the financial entangle­ ments of physicians at the most prestigious academic medical centers in the country who are receiving large payments from pharmaceutical companies to endorse and promote use of the sponsor's products. senator grassley's committee found many examples of conflicts of interest. in one case, a professor of psychiatry at emory university was receiving hundreds of thousands of dollars in speaking fees from glaxosmithkline while serving as principal investigator of a $3.95 million grant to studying new uses for several of their psychiatric drugs, yet reporting only a fraction of it to his employer. this is important because it was emory's obligation to report these payments to the national institutes of health '(''nih"), which was funding the grant, so that the nllf could review applications for renewal with full knowledge of the ex­ isting financial relationship between the investigators and the company. the correspondence from the doctor to emory explains that the university is as beholden to the company as is the individual doctor. he reminds the dean, who has chastised him for not reporting the full amount of payment: surely you remember that smith-kline beecham pharmaceuticals donat­ ed an endowed-chair to the department and there is some reasonable like­ lihood that janssen pharmaceuticals will do so as well. in addition, wyeth-ayerst pharmaceuticals has funded a research career develop­ ment award program in the department, and i have asked both astra­ zeneca pharmaceuticals and bristol-meyers [sic] squibb to do the same. part of the rationale for their funding our faculty in such a manner would be my service on these boards. 2012] whistleblower. protection for medical researchers 45 the message is clear. if emory insists on the disclosure to the nih, it may well jeopardize their receipt of future grants. this means not just the individual doctor but the institution itself will suffer serious financial loss. a whistleblower could serve at least two important functions in these situations. first, he or she could disclose the financial arrangements them­ selves. second, given both the investigators and the universities' financial interest in the study, a whistleblower would be even more valuable in dis­ closing harm to human subjects or lack suppression of negative results. 3. off-label prescribing another danger comes from the fully legal practice of "off-label'' pre­ scribing. once the fda approves a drug, any licensed physician can pre­ scribe it to any patient for any condition.197 the reason for this is the general trust in doctors to act in their patients' best interests. however, as a health policy consultant who runs a blog called "fda matters" noted in response to this event, such activity is inevitable.198 noting that salesmen are trained to sell products and that given the ''tens of thousands of sales reps [who] have millions of interactions with prescribers, [ n ]o matter how well trained and cautioned they are ... there will be days when some reps cannot restrain their 'inner salesman. '"199 a study conducted by consumer reports shows that consumers are well aware of the dangers by private meetings between doctors and sales­ men. sixty-nine percent of consumers thought pharmaceutical companies exerted too much influence on physicians' decisions to prescribe particular drugs.200 unfortunately, state laws which attempt to restrict contacts have been struck down as violations of free speech.201 this rule also creates a substantial incentive for pharmaceutical comsee letter :from charles b. nemero~ reunette w.· banis professor and chairman, emory univ. sch. ofmed. to thomas j. lawley, dean, emory univ. sch. ofmed. (may 22, 2000) (on file with author); see also marcia angell, drug companies dl: doctors: a story of cor­ ruption, n.y. rev. of books (jan. 15, 2009), www.nybooks.com/articles/22237?email. 197. almost all drugs used to treat chilchen have not been tested or approved for pedi­ atric use and are therefore applied "off-label." see jerome oroopman, the pediatric gap: why have most medications never been properly tested on kids?, the new yorker, jan. 10,2005, at 32, available athttp://www.newyorker.com/archive/2005/0l/10/050110fa_fact. 198. steve grossman, off-label promotion and whistleblowing, fda matibrs: the grossman fda report (sept. 9, 2009, 12:27 pm), available at http://www. fdamat­ ters.coml?p=479s. 199. /d. 200. see steve mitchell, consumers say big pharma influence on docs is concerning, consumer reports, (aug 24, 2010 5:55 am), http://blogs.consumerreports.org/health/ 20 10/08/consumers-say-big-pharma-influenethm.-docs-is-concerning-consumer-reports­ survey.html. 20 l. see sorrel v. ims health inc., 131 s. ct. 2653, 2672 (20 11) ("privacy is a concept too integral to the person and a right too essential to freedom to allow its manipulation to support just those ideas the government prefers.") (holding a vermont statute restricting the sale, disclosure, and use of pharmacy records revealing the prescribing practices of individu­ al doctors to be a violation offirst amendment right to free speech). 46 indiana health law review [vol. 9:1 panies to seek increasingly large markets for the drugs they have already spent hundreds of millions of dollars developing and testing. 202 the danger to the public is that any one of us may find ourselves taking a drug for a condition for which it was never proven safe or effective.z03 4. direct-to-consumer advertising the united states and new zealand are two of the few countries which allow pharmaceutical companies to advertise directly to consum­ ers.204 other countries have not permitted it because of concerns that con­ sumer demand would alter physicians' prescribing habits in ways that would be of no benefit to their patients. due to a strong washington lobby and a supreme court with increasing sympathy for commercial speech, drug companies in the united states are allowed to advertise their products directly to potential consumers, bypassing the doctors and pharmacists.205 by the time a patient in the united states arrives at the doctor, she has not 202. pfizer's payment of $2.3 billion to settle civil and criminal suits stemming from claims its pharmaceutical representatives were making about four different drugs demon­ strates that sometimes companies get caught. press release, u.s. dep't of health & human servs., justice department announces largest health care fraud settlement in its history: pfizer to pay $2.3 billion for fraudulent marketing (sept. 2, 2009), available at http://www .hhs.gov/news/press/2009pres!09/20090902a.html. 203. it is this incentive to expand markets for drugs already approved by the fda which led to yaz's efforts to finance research showing its pill safe and effective for prevent­ ing acne and pmdd. see duff wilson & natasha singer, ghostwriting is called rife in medical journals, n.y. times, sept. 10, 2009, at b5, available at http://www.nytimes.com/ 2009/09/ll/business/llghost.html;singer, supra note 169; natasha singer, senate moves to block medical ghost writing, n.y. times, aug. 19, 2009, at bl, available at http:// www.nytimes.com/2009/08/19!health!research!l9ethics.html? _ rl&scp=4&sq=&st=nyt. 204. barbara mintzes et al., i'!fluence of direct to consumer pharmaceutical advertis­ ing and patients' requests on prescribing decisions: two site cross sectional survey, 324 brit. med. j. 278, 278 (2002) ("patients' requests for medicines are a powerful driver of prescribing decisions. in most cases physicians prescribed requested medicines but were often ambivalent about the choice of treatment. if physicians prescribe requested drugs de­ spite personal reservations, sales may increase but appropriateness of prescribing may suffer. concerns about the value of opening up the regulatory environment to pennit direct to con­ sumer advertising in the eu and canada seem well justified."). but see jeremy a. greene & david herzberg, hidden in plain sight: marketing prescription drugs to consumers in the twentieth century, 100 am. j. pub. healrn 793 (2010) (pointing out the long history of patent drug marketing in the united states). 205. for a history of direct-to-consumer advertising, see jaeun shin & sangho moon, direct-to-consumer prescription drug advertising: concerns and evidence on consumers ' benefit, 22 j. consumer marketing 397 (2005) (reviewing the literature on how the public perceives direct marketing of prescription drugs and what .effect it has on their behavior), available at http://class.classmatandread.net/campaigneval/s2.pd£ see also victor e. schwartz et al., marketing pharmaceutical products in the twenty-first century: an anal­ ysis of the continued viability of traditional principles of law in the age of direct-to­ consumer advertising; 32 harv. j.l. & pub. pol'y 333, 344-51 (2009) (reviewing the his­ tory of direct-to-consumer advertising and concluding that its existence does not change the legal obligations of doctors and pharmacists to warn of dangers). 2012] whistleblower protection for medical researchers 47 only diagnosed herself with a condition, which ten years ago didn't exist, but has the name of the drug she wants to treat it. 206 other doctors com­ plain that the issue isn't so much that consumers shouldn't have a choice between which drugs to take, but that the advertisements create the impres­ sion that a specific set of symptoms requires medication. as dr. santa, di­ rector of the consumer reports health ratings center, explained in the context of advertisements for drugs which treat "leaky bladder," the ads "[g]ive you the impression the problem is more serious [than it typically is] and that treatment with drugs should be the first thing you do, when in fact for most of the people who have problems with incontinence it's a mild to moderate problem that almost universally gets better with exercise pro­ grams [such as kegels] or bladder training."207 one of the clearest examples of targeted consumer advertising is in birth control pills marketed to teenagers and young adults. "mouse around to get info on birth control & cool features," invites the website for yaz, one of the nation's top selling birth control pills?08 mousing around what looks like a retro city center surrounded by snow-capped mountains reveals opportunities to subscribe to "y az express," which offers "(p ]hotos and articles from fashion, fitness, nutrition, and style pros" as well as celeb looks, books, and music.209 not so visually attractive is a link to an eight-page, single-spaced doc­ ument in small black type setting out the risks and contraindications.210 the 206. absent any restrictions on where they can advertise, drug companies have fol­ lowed consumers from television to the web and are now building a substantial presence in social networking sites. this has not been limited to lifestyle drugs such as birth control pills. recently, the fda chastised novartis phannaceuticals for misleading the public through a widget about its tasigna, a drug intended to treat leukemia, writing that, "the shared content is misleading because it makes representations about the efficacy of tasigna but fails to communicate any risk information associated with the use of this drug." letter from karen r. rulli, ph.d., acting group leader, division of drug marketing, advertising, and communications, to lisa drucker, pharmd, mba, director, regulatory affairs­ oncology, novartis pharmaceuticals corp. (july 2010), available at http://www.fda.gov/ downloads/drugs/guidancecompliaceregulatorylnformation!enforcementactivitiesfda/ waminglettersandnoticeofviolationletterstopharmaceuticalcompanies/ucm221325.pdf. 207. kathleen doheny, consumer reports survey shows people frustrated by drug costs and worry about safety, webmd (aug. 24, 2010), http://www.webmd.com/healthy­ aginglnews/20100824/poll-patients-unhappy-with-rx-drugs. 208. yaz, http://www.yaz-us.com/ (last visited aug. 17, 2010) (the diversions of the y az website are only available to web surfers in the united states because the united states is one of the few countries which allow direct-to-consumer advertising of prescription drugs.). 209. jd 210. the full text of the fda warning letter can be found at letter from richard l. friedman, director, division of manufacturing and product quality, to dr. franz-josef renneke, site manager, bayer healthcare (aug. 5, 2009), http://www.fda.gov/ iceci/enforcementactions/warningletterslucml82206.htm. see also fda sends warning letter to makers of yaz-yarmin, u.s. recall news (sept. 17, 2009), http:/ /www.usrecallnews.com/2009/09/fda-sends-warning-letter-to-makers-of-yaz-yasmin.html; fda enforcement reports, u.s. i>ep't. of healm & human servs. (nov. 25, 2009), 48 indiana health law review [vol. 9:1 website also doesn't mention the possibility that its product will soon be recalled in the face of 25,000 lawsuits and a possible fda order. no one signing up for fashion tips or product coupons would have any indication that they are at serious risk of injury or death from blood clots from a prod­ uct with many available safer alternatives-albeit less compelling advertis­ ing.211 as prominent bioethicist and university of pennsylvania professor, arthur caplan, explained on the television show 60 minutes, "if you want to stir up worry in the public, and you've got the advertising dollars to do it, you can turn almost anything into a disease.'.z12 in the face of these dangers, it is particularly troubling that there is no comprehensive method of protecting american consumers from the dangers inherent in our current system. the next section proposes that such protec­ tion be available by providing comprehensive whistleblower protection for individuals who are likely to have the most knowledge about dangers to the public. v. why is it so difficult to get inside information: whis1leblower protection for medical researchers a. brief overview ofwhistleblowing: unknown risks and permanent harm ofwhistleblowing the practice of employees reporting the wrongdoings of their employ­ ers in order to protect the public is commonly described as "whistle blow­ ing," based on a practice in factories in which an employee could stop production by blowing a whistle if he believed there was a problem with the manufacturing process.213 the term ''whistle blowing" has come to mean someone who discloses information of interest to the public to which he or http:llwww.fda.gov/safety/recallsienforcementreports/ucm192035.htm. 211. y az needs to distinguish itself because birth control pills are more alike than they are different. all prevent pregnancy by blocking the hormones which allow an embryo, once conceived, to attach to a woman's uterus and continue to develop. as a result, the embryo dies and is naturally expelled during the next menstrual period. yet, fifty years after the marketing of the first "pill," pharmaceutical companies are still spending millions of dollars to distinguish among their products and build brand loyalty by creating distinct identities for products that differ very little in mechanism or effect. a second way y az can expand its market base is to include a consumer group of sexually active women seeking to avoid preg­ nancy. an even more creative third way, is to fund research to identify new syndromes, like pmdd, or clusters of symptoms that had not previously been treated by prescription drugs and create a market for them by, again, direct-to-consumer advertising. y az has done this by encouraging the creation of the condition premenstrual dysphoric disorder. see bayer healthcare pharmaceuticals inc., yaz: highlights of prescribing information, mar. 2011, at 4, available at http://berlex.bayerhealthcare.com/html/products/pi/fhc/y az _ pi.pdf!wt. me id=www.berlex.com. -212. howard wolinsky, disease mongering (lfld drug marketing, 6 eur. molecular biological rep. 612, 612 (2005), available at http:llwww.ncbi.nlm.nih.gov/pmc/articles/ pmc1369125/. 213. eva e. tsahuridu & wim vandekerckhove, organisational whistleblowing poli­ cies: making employees responsible or liable?, 82 j. bus. ennes 107, 109 (2008). 2012] whistleblower protection for medical researchers 49 she has access, which the public does not, by virtue of being an insider.214 while whistleblowing is beneficial for those who are protected from a harm about which they would otherwise be unaware, it is almost always a nega­ tive experience for the whistleblower himself.215 given the lack of protection available for whistleblowers, we might ask the same question as the author of a recent study: ''why would anyone in [the situation of a whistleblower] choose to go to public authorities or to their superiors with observations of organizational wrongdoing?"216 after all, she writes, there is no question that whistleblowers are putting themselves at risk because the person bringing the charge is oflesser authority in the hierarchy of the or­ ganization than is the person or persons being charged . . . . those above the whistleblower in the organiza­ tional hierarchy ... control the job performance eval­ uations that the employeelwhistleblower will receive, they control the terms and conditions of their work and under employment-at-will circumstances, they control even the capacity of the dissenting employee to remain in their job.217 moreover, even if the whistleblower sues for retaliatory discharge, "the in­ dividual incumbents who are responsible for the firing can hire all the attor­ neys they want from the company (or the public) coffer.'.218 available information on what actually does happen to whistleblowers has to raise the question, why would anyone do it? even whistleblowers who kept their jobs reported that their careers stalled afterwards, and new employers looked at them with suspicion.219 research suggests that many people who come forward with information simply do not understand the long-term consequences.220 either they believe ''that their history of excel­ lent performance in the firm will insulate them from any retaliation" or "[t]hey are generally unaware of the research literature that demonstrates 214. orly lobel, citizenship, organizational citizenship, and the laws of overlapping obligations, 91 cal. l. rev. 433, 461 (2009) ("by definition, a whistleblower is an insid­ er."). 215. see moberly, supra note 15, at 979 ("[a]lmost all the benefits of whistleblower disclosures go to people other than the whistleblower, while most of the costs full on the individual whistleblower. "). 216. joyce rothschild, freedom of speech denied, dignity assaulted: what the whistleblowers experience in the us, 56 current sociology 884, 90 i (2008). 217. id. at 900-90 i. 218. id. at 901. 219. ld. at 890. 220. ld. at 901. 50 indiana health law review [vol. 9:1 the prevalence of retaliatory findings, and they may simply underestimate that probability [of retaliation], until they are so far committed that they must now wage a war to retrieve their own honor."221 of even greater con­ cern, she writes, "most whistleblowers i interviewed mistakenly believed that the extant laws and their 'right to free speech' would protect them."222 yet, even after going through the process and learning for themselves how little protection is available, "a sizeable minority of the whistleblowers interviewed-27 percent of the internal whistleblowers and 44 percent of the external whistleblowers--even after taking a pounding for their disclo­ sures, felt that they had been effective in bringing about positive organiza­ tional change."223 this is consistent with peter rost's quotation of a study ofwhistleblowers at st. elizabeth's hospital in washington that concludes, "only 16 percent said that they wouldn't blow the whistle again," despite the negative consequences?24 whistleblower law expert professor richard moberly explains that the main reason so many whistleblowers do experience retaliation is that the law offers "limited protection. "225 one of the most serious limits is the ex­ isting laws' inability to address retaliation which does not take the form of an actual dismissal or demotion?26 another scholar described the current state of legal protection for whistleblowers in the united states as "cha­ os."227 the life of any whistleblower, regardless of the presence of legal pro­ tection, is a difficult one. writing about the role of whistleblowers in cor­ porate america, professor elizabeth tippett notes the pervasive "stigma" associated with whistleblowing.228 she writes that, "[e]ven when whistle­ blowers are ultimately vindicated, like the pair of nasa engineers who disclosed the technical failures that led to the challenger disaster, they are often subject to continuing social marginalization by co-workers."229 some whistleblowers triumph, like harry markopolus, who is credited with trying to blow the whistle on bernie madoff; coleen rowley who 221. id 222. id. 223. id. at 892. 224. peter rost, the wtnstleblower confessions of a healthcare hltman front matter (2006). 225. moberly, supra note 15, at 977. 226. see generally id. 227. dacosta, supra note 17, at 957. these varying legislative and judicial approaches to the adverse employer action element under state and federal laws leave many whistle· blowers inadequately protected against retaliation that falls short of termination. a standard that prohibits only actual discharge is most glaringly deficient because it permits an employ• er to retaliate in any manner, no matter how egregious, short of officially terminating a whis­ tleblower. see also johnson, supra note 17. 228. elizabeth c. tippett, the promise of compelled whistleb/owing: what the cor­ porate governance provisions ofsarbanes oxley mean for employment law, 11 empl. rts. & employ. pol'y j. 1, 3 (2007). 229. id. at 16. 2012] whistleblower prpti:ction for medical researchers 51 warned the fbi before the terrorist attacks on 9-11 of suspicious activities in local flight schools; and ~erron watkins, who it is said brought down enron with a single phone caill. such individuals enjoy public approbation and perhaps even lucrative cjlreers as motivational speakers. time maga­ zine voted rowley and wat!9ns "person ofthe year" for 2002.230 howev­ er, for every successful whistleblower, there are hundreds more who have suffered significant retaliatio~. this is true even if the whistleblower does not suffer, what could be de1jined legally, as adverse consequences includ­ ing firing or demotion. given this grim progno~is, mo~t would wonder why would anyone do it. yet the research shows that rather than being unsophisticated people unaware of the consequences of their actions, or social misfits who are simply making things difficult for their employers, it turns out that whistle­ blowers are often the most loyal employees. 231 b. whistleblowers '/{istorical role in science and medicine the doctor's oath is to do no harm and the scientist's is to be honest about results. there is a lo~g tradition of whistleblowing in science and medicine by both public an~ private employees, but it is not one which would provide any comfort to individuals who are considering reporting misconduct. describing twp cases in which medical researchers faced harsh punishments, ethicists rosalind rhodes and jj strain write: i to effect a chang~ in the current status quo the incen­ tives for addressing problematic behaviour have to be changed. ethicallr appropriate reactions to researcher misconduct would! be far more likely if whistleblow­ ers could be seen 118 helpful colleagues and as valued friends of the institution instead of its enemies. we advocate this kin4 of transformation, not only to ad­ dress the misde~d · of academic medicine but to create a moral enviro t for all who have to work in it and learn from it.2 . 2 discussing whistleblowjng in the healthcare industry, professor leslie ! 230. "persons of years past: thia cooper, coleen rowley and sherron watkins," time, http://www.time.com/ · e/specialslpackages/article/0,28804,1946375 _1947772_ 1947759,00.html (last visited mar. 7, 2012). 231. robert a. larmer, whist eb/owing and employee loyalty, 11 j. bus. ennes 125128 (1992). 232. rosamund rhodes & j .. strain, whistleblowing in academic medicine, 10 j. med. ennes 30, 35 (2004); see als thomas a. faunce et al., supporting whistleblowers in academic medicine: training and especting the courage of professional conscience, 10 j. med. ennes 30, 40 (2004). 52 indiana heal til law review [vol. 9:1 griffin defines whistleblowers as "individuals who report misconduct" and further describes them as "frequently fac[ing] retaliation for doing so."233 many have suggested that the very nature of scientific research, activity taken far outside the view of the public which could cause serious threats to health and safety, imposes an obligation on scientists to be whistleblowers when they perceive danger.234 citing the example of two government sci­ entists who received extensive press coverage as whistleblowers, griffin writes, "state and federal law's treatment of health care whistleblowers is comprehensive and complex. wise health lawyers will anticipate the whis­ tleblowers in their midst and establish appropriate programs and procedures to prevent both misconduct and retaliation long before the whistleblower' story appears on cnn. "235 unfortunately, whistleblowers in science and medicine face the same risk of retaliation as those in other industries. there are many examples of scientists who have blown the whistle on what they believed to be either research misconduct or suppressed information about prescription drugs already on the market. almost all stories end badly.236 c. researchers in drug research are also bound by confidentiality agreements, which impose penalties for violation of the company's trade secrets for example, dr. david kern was a physician employed by brown university-he served as a consultant for a company that manufactured flocking material.237 dr. kern began to notice the presence of a rare lung disease in the workers he treated. he drafted an abstract for a professional 233. leslie griffin, watch out for whistleblowers, 33 j. l. med. & ennes 160, 160 (2005). 234. see generally thomas a. faunce & susannah jefferys, whistleblowing and sci­ entific mzsconduct: renewing legal and virtue ethics foundations, 26 j. med. & l. 567, 581-82 (2007) (citing lack of general awareness of basic principles of research ethics such as the declaration of helsinki, the authors suggest that "[i]n a research environment that is blind to its contribution to the greater public good, its own ethical standards and under financial pressure, the role of the whistleblower is even more crucial in uncovering scientific miscon­ duct and preventing it from continuing. ultimately the scientific research community needs to educate and pay due respect to not only research ethics, but also to remove the fear and shame involved and legitimize whistle blowing and the whistleblowers by instilling in young researchers' character the belief in this greater good or telos.''). see also michael davis, some paradoxes of whistleblowing, 15 bus. & prof'l ennes j. i, 7 (1996) (developing a theory that whistleblowing is "morally required" for a member of any organization with well founded knowledge that others are threatened by "serious harm" which they would otherwise be unaware, extending this obligation beyond scientists). 235. griffin, supra note 237, at 160. 236. see interview with dr. little, available at http://www.dailymotion.com/ vid­ eo/xdey8b_kitty-little-whistleblowing-scienti_news (last visited nov. 21, 2011). 237. for accounts of the events which resulted in dr. kern's firing, see statement from brown university on academic freedom of dr. david kern (may 21, 1997), available at http://www.brown.edu/ administration/news_ bureau/1996-97 /96-133.html. 2012] whistleblower protection for medical researchers 53 conference, but the company told him that the publication would be disclos­ ing trade secrets, which was in violation of dr. kern's contract.238 to pre­ vent this problem, dr. kern redrafted his abstract to further obscure the identity of the company. at this point, the company contacted brown uni­ versity and threatened suit. the university then asked dr. kern to withdraw the abstract. he did not and went ahead with publication. 239 he then faced retaliation by both the company and by brown university.240 while a few scientific whistleblowers occasionally receive large mon­ etary awards, it is likely that they will no longer be able to work in scien­ tific research, the field to which they have devoted extensive years of training. 241 in a 1995 report on the results of a research study of whistle­ blowers submitted to the ori, dr. lawrence rhodes wrote, unfortunately, a small but significant proportion of complainants reported very serious consequences of their whistleblowing. at least ten percent of com­ plainants reported each of the following: eight whis­ tleblowers (12%) reported being fired, not being renewed, and/or being denied salary increases, 14 re­ ported losing research support (21% ), and 7 whistle238. robert r. kuehn, 30 am. j.l. & med. 333, 33~36 (2004). although it is reason­ able for pharmaceutical companies to want to protect their intellectual property through non­ disclosure agreements, those agreements should be used to shield dangers to the public health. several commentators have noted the harmful effects of these agreements in the specific context of pharmaceutical companies. see 'di<>mas 0. mcgari'iy & wendy e. wagner, bending science: how special interests corrupt pubuc health research 111 (2008) (explaining that "companies can invoke confidentiality clauses in employee con­ tracts" to prevent current and former employees from revealing "secret research''). professor jerome reichman describes these non-disclosure agreements as symptoms of the inherent conflict of interest from a company which stands to profit from marketing a drug to do its own clinical trials. he writes, a better alternative to calls for mandatory disclosure is to remove the di­ rect link between the test sponsor (the drug company) and the drug test­ ers. one approach would be to establish an independent testing agency to conduct clinical trials under specified conditions of transparency. un­ like the current system, drug companies would no longer directly com­ pensate the scientists evaluating their own products. instead, the scientists would now work for the testing agency, supported by general funds collected from the pharmaceutical industry. jerome reichman, rethinking the role of clinical trial data in international intellectual property law: the case for a public goods approach, 13 marq. intell. prop. l. rev. 1, 50-51 (2009). 239. kuehn, supra note 241, at 33~36. 240. id. 241. becky maclaine is a biologist who recently recovered $1.37 million from pfizer based on her claim that she was fired for raising concerns about research she was doing for pfizer on genetically engineered viruses. maclaine alleged she had been made sick from the virus. andrew pollack & duff wilson, a pfizer whistle-blower is awarded $1.4 million, n.y. times, apr. 2, 2010, available at http://www.nytimes.com/2010/04/03/business/ 03pfizer.html. 54 indiana health law review blowers (1 0%) reported losing staff support and/or re­ ceiving less desirable work assignments. 242 [vol. 9:1 again, it is important to keep in mind that these consequences often happen to the same people. in fact, just twenty whistleblowers are respon­ sible for the seventy consequences reported under the top three headings in the table contained in the 1995 report.243 on one hand, these findings refute the notion that every whistleblower suffers substantial negative consequence. on the other hand, they confirm that whistleblowers frequently face the prospect of significant hardship for their efforts. a substantial proportion suffers at least some difficulties as a result of blowing the whistle, and a sizeable group suffers devastating con­ sequences, such as losing their jobs.244 unfortunately, there is little evi­ dence that "appropriate regulations and enforcement procedures" were ever developed as a result of this research, jet alone that they reduced retalia­ tion.245 vi. why existing whistleblower protection laws don't work existing statutes are oflittle use in protecting those with knowledge of danger from human subject research because the location and employment status of potential whistleblowers are so broad. most existing whistleblow­ er statutes privilege employment status as a starting point for offering pro­ tection against retaliation. in many cases this is reasonable because the most likely source of retaliator is the specific entity for which the whistle­ blower works. however, the area of drug development employment status is far too narrow. because not all who report are employed by the compa­ ny, they do not face retaliation from their employer. this is especially true in the case of doctors, scientists, and their staffs ("researchers")/46 who de242. lawrence rhoades, consequences of whistleblowing for the whistleblower in misconduct in science cases 17 (1995), available at http:// ori.hhs.gov/documents/consequences.pdf. 243. id. 244. id. 245. id.; thomas a. faunce & susannah jefferys, whistleblowing and scientific mis­ conduct: renewing legal and virtue ethics foundations, 26 meo. & l. 567, 576 (2007) ("a timely recent example of this has concerned the us food and drug administration (fda), where whistleblowers such as dr[.] david graham have indicated that fda scientists have been discouraged by supervisors from raising questions about drug safety and sometimes have been prevented from sharing their concern with fda advisory committees."). 246. there is no single word which describes all of the people who are likely to be involved in research studies intended to affect medical care. almost all ofthe people leading a medical research team are physicians with an m.d. degree and, increasingly, also a ph.d. in a biomedical field. these doctor/scientists usually hold academic appointments in univer­ sities even though their research is usually funded by the federal government or a private foundation or private company. as medical research becomes increasingly complex and expensive, with much research now being done at the level of the genome, physicians con2012] whistleblower protection for medical researchers 55 sign and run the clinical trials before, and sometimes after, the drugs go on the market. despite their important role, researchers who see problems ana who express their concerns, even within their own institutions, do so at the risk of their careers and livelihood.247 there are model statutes that provide protection based on the content of the information, rather than on employ­ ment status. they must be the foundation of any new fda rule. the system of law and regulation in the· united states to provide pro­ tection against retaliation for insiders who know of dang.ers to the public's health and safety during human subject research or drug development is as fragmented and inconsistent as regulating the research itself. arguing that the current laws intended to encourage whistleblowing were ineffective, former supreme court justice souter described 1he uncoordinated and in­ consistent federal and state whistleblowing statutes as inadequate because the protection they provided was ''piecemeal," 'patchwork," and "hodge­ podge. "248 it is the lack of comprehensive protection over research and over whistleblowers that makes it so easy to hide dangers at every stage of the process. another problem is that the existing laws often narrowly describe who ducting funded research usually also have doctorates in a medi~al science such as biochemis­ try. these m.d./ph.d.s, however, only represent a fraction of those who would have direct involvement in ongoing studies or in the presentation of applications ·for approval to the fda. whether the research is taking place in a university hospital, a private hospital, or a private company's own testing facility, there are likely to be hundreds of people ranging from medical students and nurses to professional study coordinators to pharmacists to hospi­ tal cleaning staff who care for the patients/subjects and may have important information about the study. less visibly, pharmaceutical companies employ health care professionals to oversee and run studies either at academic medical centers or freestanding facilities. finally, the government itself directly conducts clinical research on the campus of the national insti­ tutes of health. any individual at any of these locations may have direct access to infor­ mation about a research study which presents a direct danger to the public's health or safety. it is because there are so many different people in so many different settings and geographic locations with so many job titles who have access to.information that there needs to be pro­ tection based on the subject matter of the disclosure. 24 7. many commentators have noted the failure of the current system to protect whis­ tleblowers. writing recently about the case of suzanne stratton, who was fired from her job at carle foundation hospital for challenging the general lack of compliance with human subject safety provisions, jonathan rackoff noted that although she had been vindicated by the government's regulatory agency, the office for human research protections ("ohrp"), she was not reinstated. jonathan rackofi, whistle-blower protection a must: individuals who report ethical misconduct unfortunately often put their jobs on the line, 30 gen 1 (201 0), available at http://www.genengnews.com/gen-articleslwhistle-blower-protection-a­ must/3187/ (last visited nov. 11, 2011). 248. griffin, supra note 237, at 160 (citing miriam a. cherry, whistling in the dark? corporate fraud, whistleblowers, and the implications of the sorbanes-oxley act for em­ ployment law, 79 wash. l. rev. 1029, 1049, 1064 (2004)); peter r. marksteiner, the fly­ ing whistleblower: it's time for federal statutory protection for aviation industry workers, 25 j. legis. 39, 41-42 (1999) ("dozens of federal and state statutes and a hodgepodge of common law doctrines provide whistleblower protections ior workers who report safety violations in a host of different industries."); richard e. moberly, unfolfil/ed expectatiof'is: an empirical analysis of why sarbanes-ox/ey whist/eblowers rarely win, 49 wm. & mary l. rev. 65 (2007); see generally elletta s. callahan & terry m. dworkin, the state of state whistleblower protection, 38 am. bus. l.j. 99 (2000). 56 indiana health law review [vol. 9:1 is protected for disclosing various kinds of information. professor richard moberly, an expert in whistleblower law, described research showing that in the existing statutory and common law .. [p]rotections consistently fail to redress retaliation against whistleblowers, in large part because whistle­ blowers fail to fit their claim into the narrowly-drawn boundaries of the law.'t249 a system this broken cannot be fixed by a stroke of the pen. ra­ ther, protection of the public must be pursued using several different legal and policy interventions. a. lack of constitutional protection 1. medical researchers are not protected by the first amendment? in garcetti v. cebalos, the supreme court concluded that there is no first amendment protection for employees of public institutions who dis­ close information against the wishes of their employers. 25° finding that wrongdoing is part of their jobs makes it unlikely that medical researchers employed by public universities would have first amendment protection from retaliation for disclosing their concerns about dangers to the public's health from a clinical trial or a newly issued prescription drug.251 those who argue garcetti v. ceballos has not resulted in any diminution of whis­ tleblower protection for public employees because the plaintiff, mr. ce249. moberly, supra note 15, at 977 (proposing that employers be required by law to include anti-retaliations provisions in their codes of conduct); see also moberly, supra note 252, at65. 250. garcetti v. ceballos, 547 u.s. 410 (2006). 251. id at 441 (souter, j., dissenting). first amendment protection, if available, would go beyond the whistle­ blower protections required by the contracts between the university and the nih. it is not the funding source of the research that is relevant, but rather the employment status of the. researcher. before garcetti, em­ ployees of public universities bad at least two sources of protection una­ vailable to employees doing the same kind of work at private universities. first, public employees may have been protected by the first amendment ''public employee speech" doctrine that bad developed through pickering. second, employees at public universities bad the same whistleblower protection as any other employee of their individual state. there is no question that the garcetti decision bas bad a negative effect on public employees who report what they consider wrongdoing within the scope of their own job description. see, e.g., david l. hudson, jr., commentary: public-employee speech and the garcetti effect, getlegal (sept. 28, 2009), http://public. getlegal.comlarticleslgarcetti-effect (de­ scribing the. garcetti decision as "having a negative impact on the functioning of our demo­ cratic government" and stating ''that garcelti creates an additional threshold hurdle that most claimants will ha've a tough time clearing. as one plaintiff's attorney told me, many of his clients have been 'garcettized.' after garcetti, the importance of the information is not relevant. many employees have spoken out on matters of public concern-even rank cor­ ruption in the workplace-but if the speech can be classified as official. job-duty speech they have no first amendment protection."). 2012] whistleblower protection for medical researchers 57 ballos, was not himself a whistleblower miss the point.252 the minority's strongest objection was the chilling effect this decision would have, and it specifically identified the reduced protections for whistleblowers by elimi­ nating any possible extension of first amendment rights.253 although em­ ployees of state universities will still have the state whistleblower protection, these statutes are often narrowly focused on reports about waste fraud and abuse in state government and would not apply to a study funded privately.254 the supreme court recently reaffirmed the importance of these regu­ lations, writing that "[ e ]xposing governmental inefficiency and misconduct is a matter of considerable significance .. but pointed to a ''powerful network of legislative enactments-such as whistle-blower protection laws and labor 252. see lawrence rosenthal. the emerging first amendment law of managerial prerogative, 77 fordham l. rev. 33, 56 (2008) (arguing that since ''ceballos learned of the circumstantial evidence suggesting police petjury from the defense counsel • . . not as the result of any information in the exclusive possession of the district attorney or sherriff's office," his memo to his superior that the sheriffs were going to offer false testimony was merely an expression of his opinion, not "the disclosure of otherwise suppressed evidence of governmental misconduct."). 253. garcetti, 547 u.s. at 437-41 (souter, j .•. ~~ing). 254; for exampte, a scientist at a state university who felt human subjects were being mistreated or results of a study funded by a pharmaceutical company were being suppressed may well not be covered depending on the wording of her state's whistleblower statute pro­ tection against retaliation in a qui tam lawsuit. if the court finds a whistleblower was terminated or otherwi~ mistreated for filing a qui tam lawsuit, the employee is entitled to reinstatement at the same seniority level as if he or she had never left the company, two times the amount of back pay owed plus interest, and compensation for any 'special damages' sustained as a result of the discrimination, such as attorneys' fees (see section 3729 of the false claims act). taxpayers against fraud education fund. the false claims act legal center, information for whistleblowers, http://www.taf.org/whistleblower.htm (last visited aug. 22, 2009); see also complaint, state of california ex rel. hunter laboratories, llc and chris riedel vs. quest diagnostics inc. (no. civ 450691), available at http://ag.ca.gov/cms_attachments/ presslpdfs/n1705 _complaint_ asfiled.pdf. until the court's decision in garcetti, first amendment scholars, whose discipline is shaped opinion by opinion, had believed the parameters of first amendment protection for the speech of public employees were well outlined by a series of cases which established what was called ''the public speech doctrine." the first amendment center's legal corre­ spondent tony mauro explained that, "[a]fter yesterday's ruling, ... many· ... first amendment advocates' and analysts were left feeling that the high court had departed significantly from its traditional approach to government-employee speech, which included fteedom of speech as one of the factors to be balanced in deciding whether an employee's speech should be protected. . tony mauro, head-scratching follows garcetti ruling, first amendment center, may 31,2006, http://www.fustamendmentcenter.org/head-scratching-follows-garcetti-ruling. the court distinguished speech that was part of a public employee's job descrip­ tion from the general opinions of a public employee about the activities of the government outside his or her own place of work. garcetti, 547 u.s. at 417-20. 58 indiana health law review [vol. 9:1 codes--available to those who seek to expose wrongdoing."255 however, noting an inconsistency between the court's holding in pickering and garcetti, justice souter wrote, [it] is not a whit less true when an employee's job du­ ties require him to speak about such things: when, for example, a public auditor speaks on his discovery of embezzlement of public funds, when a building in­ spector makes an obligatory report of an attempt to bribe him, or when a law enforcement officer express­ ly balks at a superior's order to violate constitutional rights he is sworn to protect. (the majority, however, places all these speakers beyond the reach of first amendment protection against retaliation. i 56 furthermore, despite the existence of both federal and state whistle­ blower statutes, most people know that disclosing information one's em­ ployer chooses to keep secret will likely lead not only to being fired but also to becoming unemployable. the lack of protection for whistleblowers means that those with the best information about dangers to participants in medical research and to the patients, who will eventually use the products developed from, the scientists, researchers, and doctors conducting the ex­ periments and analyzing the data, risk their jobs and their futures if they bring this information to light either within their own company, to govern­ ment regulators or to the press.257 it is as an employee of a public institution that a research scientist would be able to claim protections beyond that available to those employed by private universities or indeed private companies.258 interpreting garcet255. garcetti, 547 u.s. at 424-26. 256. !d. neither whistleblowing nor research misconduct are exclusively american phenomenon. australia has devoted considerable resources to funding a study of what hap­ pens to government whistleblowers in an effort to see whether existing legislation provides enough protection. see generally tess livingstone & brendan o'malley, laws fail those who speak up, the whistle, nov. 2005, at 3, available at www.bmartin.cc/dissent /contacts/au_wba/whistle2005ll.pdf (whistleblower at world bank revealed wolfowitz's financial records http:/lblogs.wsj.com/washwire/2007/05/15/whistleblower-seeks-change-in­ world-bank-governance/); wikileaks, http://www. wikileaks.chl about.html (last visited aug. 12, 2009) (the website wikileaks describes its mission "as seeking worldwide justice through strong transparency."). 257. many commentators have noticed the inconsistency between protection offered to sources who provide information to the press and lack of protection for whistleblowers who make internal reports to their superiors, as ceballos did; see jenny mendelsohn, calling the boss or calling the press: a comparison of british and american responses to internal and external whistleblowing, 8 wash. u. global stud. l. rev. 723 (2009) (comparing us and uk laws on internal whistleblowing verses leaking information to the press). 258. the question raised is whether first amendment restrictions on medical research­ ers employed at public universities are actually restrictions on academic freedom. the short 2012] whistleblower protection for medical researchers 59 ti, the fifth circuit found that there was no constitutional protection ''when a public employee raises complaints or concerns up the chain of command at his workplace about his job duties.'a59 writing four years after garcetti, however, it is possible to see that garcetti is already being cited to support ruling against professors engaged in disputes with administrators at public universities?60' 261 a. federal whistleblower law provides little protection for federal employees and none for private employees there is a long tradition of government employees as whistleblowers in the united states. in a 1991 article describing the role that whistleblowanswer to that question is "we don't know." the supreme court specifically declined to address the issue of academic freedom. the majority opinion rather cryptically states that although justice kennedy's majority opinion made clear that it did not see garcetti as a statement suggesting professors at public universities no longer had the first amendment protection associated with academic :freedom, it is hard to imagine that it reserved any such protection for the disclosure of information by employees of public universities-regardless of their status as professors. the supreme court deh'berately did not elaborate on how its decision in garcetti would affect academic freedom. professor paul horowitz makes the interesting observation that although the supreme court often acts as if the professors at public universities have special status under the first amendment; it is difficult to pin down where that status is rooted in either the constitution or later interpretations of it. see cynthia estlund, free speech rights that work at work: from the first amendment to due pro­ cess, 54 uclal. rev. 1463, 1469 (2007) ("the meaning ofgarcetti for teachers and schol­ ars remains unresolved; the court bracketed those issues as ones in which academic freedom may play a role."); paul horowitz, universities as first amendment institutions: some easy answers and hard questions, 54 ucla l. rev. 1497, 1513 (2007) ("practically speaking, courts have already accepted that universities play a distinct role in our first amendment firmament. the united states reports are replete with examples of the supreme court ex­ tolling the unique, and uniquely important, role played by universities in the accumulation and advancement of knowledge [and in contributing to public debate. to this day, the court's decisions continue to recognize the special role played by universities in public dis­ course, and to tread lightly around any suggestion that general rules that are otherwise appli­ cable under standard first amendment doctrine would apply in the same way in the university context."). 259. davis v. mckinney, 518 f.3d 304,313 (5th cir. 2008). 260. helen norton, constraining public employee speech: government's control of its workers' speech to protect its own expression, 59 duke l.j. l, 12 n.44 (2009) ("speech on university governance issues, however, may be unprotected after garcetti even if speech related to scholarship and teaching receives some sort of academic freedom protec­ tion.") (citing renken v. gregory, 541 f.3d 769, 774 (7th cir. 2008) (applying garcetti to conclude that the first amendment does not protect a tenured professor's complaints about a university's use of grant funds because they were made pursuant to his official duties)); hong v. grant, 516 f. supp. 2d 1158, 1167-68 (c.d. cal. 2007) (applying garcetti to con­ clude that the first amendment does not protect a professor's critical statements regarding the hiring and promotion of other professors and the use of lecturers because this speech was uttered pursuant to his official duty to participate in university governance)). 261. the strongest argument that garcetti did not change the extent of first amend­ ment protection available to public employees but rather clarified its scope is that no previ­ ous case interpreting protection of public employees' speech involved a dispute with the speaker's employer over an issue arising in the course of his job. id. 60 indiana health law review [vol. 9:1 ers play in the federal government,262 professor bruce d. fisher wrote, federal whistleblowers have exposed alleged defense contractor accounting improprieties, described possi­ ble misconduct and federal prison mismanagement, highlighted mismanagement of federal health care for native americans, questioned the administration of the united states' system of justice, and alleged nu­ merous improprieties in the administration of federal agencies. whistleblowing can occur at high and low levels of the federal government. whistleblowers can save the federal government-and federal taxpayers­ -billions of dollars. whistleblowers can serve as a vi­ tal communication link between the middle echelon federal employee, who sees the workings and short­ comings of federal programs on a daily basis, and the policy-makers in congress.263 yet, the title of professor fisher's article, the whistleblower protec­ tion act of 1989: a false hope for whistleblowers, reflects the fact that despite substantial efforts on the part. of congress to provide a regulatory scheme to protect whistleblowers, they still very much face retaliation and, in many cases, disgrace. all federal employees, including scientists, are protected under the ex­ isting federal whistleblower statute.264 however, that act is focused narrow­ ly and weakly enforced. whatever protection it provides federal employees is inadequate to protect human subjects or consumers of prescription drugs.26s in not just health and safety issues but rather in all areas of possible wrong-doing, the federal government has moved beyond a passive posture 262. bruce d. fisher, the whistleblower protection act of 1989: a false hope for whistleblowers, 43 rutgers l. rev. 355,357 (1991). 263. id at357. 264. pamela h. bucy, information as a commodity in the regulatory world, 39 hous. l. rev. 905,951 n.255 (2002). for example, grace pieree, m.d., was demoted from her position as as­ sociate director of medical research at ortho pharm8ceutical corp. af­ ter she refused to proceed on human trials that both she and her fellow researchers considered carcinogenic . . . . although dr. pierce's position on the carcinogenic nature of the drug in question was supported by food and drug administration (fda) guidelines, her supervisor, the executive director of medical research, 'accused her of irresponsibility, lack of judgment, and conduct unbecoming a director.' id (citation omitted). 265. garcetti, 547 u.s. at 436-33 (souter, j. dissenting) (quoting san diego v. roe, 543 u.s. 77, 82 (2004) (per curium)). 2012] whistleblower protection for medical researchers 61 of relying on laws that protect those who come forward to laws which both provide bounties as an incentive and punishments for not doing so. b. characterizing hiding information about a drug as a false claim against the government congress has long seen the need for providing protection to federal employees who learn of fraud, waste, or abuse in government as well as employees of private companies who receive federal money, but this pro­ tection does not usually extend to dangers to the public's health and safety. writing to sixteen of the largest pharmaceutical companies on july 1, 2010, senator chuck grassley oflowa demanded that they each send his commit­ tee their company's policies on protecting whistleblowers. as he explains in a press release, the false claims act is a proven success in both identifying and deterring fraud and recovering fraudu­ lently obtained taxpayer dollars. the more that can be done to create awareness of it, the more good it can do. my appeal to drug makers is based on the fact that they have a public responsibility to safeguard the tax dollars that pay for their products, and promoting a congress has long seen the need for providing pro­ tection to federal employees who learn of fraud, waste or abuse in government culture where those who speak up about possible fraud are rewarded rather than retaliated against is one way to fulfill that re­ sponsibility . . . . there can never be too many tax­ payer watchdogs, so i see this letter as an opportunity to foster a mindset that recognizes the value of whis­ tleblowers and the duty these companies have to act honestly when seeking taxpayer dollars. 266 b. neither qui tam statutes nor bounty programs are not a substitute for whistleblower protection the federal government has recently stepped up its efforts to fight fraud in a variety of settings by making it easier for individuals who know of fraud, waste, or abuse of federal funds to receive a substantial financial benefit by coming forward with the infonnation. these efforts include 266. press release, charles grassley, charles grassley works to empower whistle­ blowers, protect tax dollars (july 1, 2010), available at http://www.grassley.senate.gov/ news/article.cfi:n?customel_datapageid_is02=27347. 62 indiana health law review [vol. 9:1 strengthening a very old incentive, qui tam suits, and a newer one focusing on bounties. both link the whistleblower's recovery directly to the amount recovered by the government. these programs are successful because they directly address the problem for which they were designed: fraud, waste, and abuse against the federal government. the whistleblower provisions in this article, however, are aimed at saving money, they are aimed at saving lives. courts have suppc:;rted the government's recent efforts to characterize actions by pharmaceutical companies to hide dangers as false claims be­ cause the drugs themselves were subsequently purchased through the medi­ care or veterans health administration systems. however, neither the availability of a qui tam suit nor a bounty program will make it more likely than informant who·knows of a danger which does not involve a substantial financial loss to the federal government. 1. qui tam actions in 1863, the united states congress adopted a venerable english legal doctrine called qui tam in order to allow private citizens to bring lawsuits on the government's behalf in order to recover from individuals and corpo­ rations who had defrauded the government by submitting false bills for ser­ vices.267 under the false claims act,268 the federal government has developed a program through which private citizens are authorized to bring lawsuits whcm in return for a share of the money recovered. this extension of federal authority is intended to expand the government's resources for recovering funds lost to waste, fraud, or abuse. although by no means re­ stricted to the area of health law, suits against hospitals, doctors, and other participants in the federal medicare program are extremely lucrative and the government is quick to publicize large dollar victories. taxpayers against fraud, a nonprofit organization, reports that whistleblowers have helped state and federal governments recover $3;9 billion dollars between fiscal years 2002 and 2006.269 267. for an excellent history of the development of the false claims act see eric m. fraser (comment}, reducing fraud against the government: using foia disclosures in qui tam litigation, 15 u. cm. l. rev. 497, 501-504 (2008). 268. the false claims act is codified at 31 usc§§ 3729-33 (2000) and in relevant part states that "a person may bring a civil action for a violation of section 3729 for the per­ son and for the united states government." 31 u.s.c § 3730 (2011). andy schneider, the role of tiie false claims act in combatting medicare and medicaid fraud by drug manufaclurers: an update (2007), available at www.taforglschneider07drugreport.pdf. 269. according to the report, if you are still employed by the company you file a qui tam case against, your identity will remain secret so long as your case is under seal with the u.s. justice department in some cases an employer may guess which employee blew the whistle based on the past actions of the relator and/or the types of questions being asked by the government. harass­ ment or ostricization by management and fellow employees is common 2012] whistleblower protection for medical researchers 63 qui tam actions are available to those who suspect fraud or wrong doing on the part of pharmaceutical companies if that fraud takes the form of billing the federal government through medicaid, medicare, or the vet­ eran's health administration. writing of pfizer's $2.3 billion settlement of allegations that it promoted off-label use of drugs which were then paid for through federal programs, blogger steve grossman notes that qui tam whis­ tleblowers brought the wrong-doing to light and stood to gain substantial profit from their share in the recovery?70 however, there are dangers to bringing these actions and not all cases of danger to the public result in sub­ stantial financial recoveries. while the law protects those bringing these suits, called relators, from retaliation, they often experience retaliation any­ way. a study of qui tam actions brought between 1996 to 2005 published in the annals of internal medicine found that despite "a strict prohibition on retaliatory action against whistleblowers" under the statute, "the cases we analyzed frequently included descriptions of the considerable pressures put on whistleblowers and the many unpleasant experiences they faced after helping initiate doj enforcement actions.'.z71 for example, according to the authors of the study, a physician who brought an action against his hos­ pital ''reported that his hospital employer fired him and then prevented him from informing his patients of his relocation. "272 this led the authors to conclude that despite the potential for significant financial gain, "[t]he on­ going viability of the qui tam model depends on the willingness of whistle­ blowers to come forward.'.z73 the issue of ''willingness to come forward" is an important distinction between those contemplating a qui tam action and the medical researcher with knowledge of harm to a human's health or safety. research suggests that those bringing qui tam actions do so in order to make money. 274 the pfizer case was brought by a drug representative who claimed to be "apin such situations, and the whistleblower may even be fired. demoted, or suspended. what are false claims act cases?, taxpayers against fraud education fund, http://www.taf.org/whistle blower.htm (last visited feb. 12, 2012). 270. grossman, supra note 202. 271. aarons. kesselbeim & david m. suddert, whistleblower-initiated enforcement actions against health care fraud and abuse in the united states, 1996 to 2005, 149 annals of internal med. 342 (2008) (a study of379 cases brought by private individuals alleging violations of medicaid and medicare laws showing that between 1996 and 2005, these whistleblowers received over $1 billion as their share of the $9.3 billion recovered by the federal government). 272. id. at 347 (citing james s. lubalin and jennifer l. matheson, the fallout: what happens to whistleblowers and those accused by exonerated of scientific misconduct?, 5 sci. eng. ennes 229 (1999)). 273. id. 274. christina broderick, note, qui tam provisions and the public interest: an empir­ ical analysis, 107 cowm. l. rev. 949, 961-63 (2007) (reviewing data showing qui tam relators are motivated by money). 64 indiana health law review [vol. 9:1 palled by pfizer's tactics in selling the pain drug bextra.'.275 he and five other whistleblowers will share a recovery of$102 million dollars. howev­ er, in the case of a medical researcher or pharmaceutical company employee who seeks to lose her job and perhaps her career, even that amount of mon­ ey would not be worth the likelihood of having to find another career. since this article is concerned with encouraging those with knowledge of a patient's health or safety to come forward, regardless of whether there is a high dollar recovery available, the whistleblower protection provisions of the false claims act are no substitute for comprehensive protection. if effective and comprehensive whistleblower protection were available, it may be preferable to qui tam actions and may encourage more people with knowledge to come forward. although the qui tam statutes provide protection against retaliation, retaliation is not nearly as much a problem because the kinds of people who bring these actions only do so with the benefit of substantial documentation. whistleblower statutes, on the other hand, are there to provide incentives when there is no financial gain to anyone. 2. federal whistleblower laws there are at least twenty-one federal statutes that incorporate explicit whistleblower protection for employees of private companies.276 these in­ clude ''protect[ing] employees who report violations of various airline, commercial motor carrier, consumer product, environmental, financial re­ form, food safety, health care reform, nuclear, pipeline, public transporta­ tion agency, railroad, maritime and securities laws," and are overseen by the occupational safety & health administration (osha) through its office of the whistleblower protection program (owpp).277 the owpp defines its protection as follows, the occupational safety and health act (osh act) and a number of other laws protect workers against retaliation for complaining to their employers, unions, 275. bill berkrot, pfizer whisrleblowers ordeal reaps big rewards, reuters (sept. 2, 2009), http://www.reuters.com/article/2009/09/02/us-pfizer-whistleblower-idusn021592 920090902. 276. the whistleblower program, u.s. dep't labor, http://www.whistleblowers.gov/ index.html (last visited feb. 12, 2012). 277. these acts are section ll(c) of the occupational safety and health act of 1970 (osha); the surface transportation assistance act of 1982 (staa); the asbestos hazard emergency response act of 1986 (ahera); the international safe container act of 1977 (isca); the safe drinking water act of 1974 (sdwa); the federal water pollution control act of 1972 (fwpca); the toxic substances control act of 1976 (tsca); the solid waste disposal act of 1976 (swda); the clean air act of 1977 (caa); the comprehensive envi­ ronmental response, compensation and liability act of 1980 (cercla). /d. 2012] whistleblower protection for medical researchers the occupational safety and health administration (osha), or other government agencies about unsafe or unhealthful conditions in the workplace, environ­ mental problems, certain public safety hazards, and certain violations of federal provisions concerning se­ curities fraud, as well as for engaging in other related protected activities.278 65 according to the act, "( w ]histleblowers may not be transferred, de­ nied a raise, have their hours reduced, or be fired or punished in any other way because they have exercised any right afforded to them under one of the laws that protect whistleblowers."279 however, even if the owpp could effectively manage the retaliation complaints it receives, it would not pro­ vide protection for those who learn of danger to the public's health and safety unless that danger was of the type prohibited by a federal law or reg­ ulation. here again, the fragmentation of human subject research is a sub­ stantial barrier to comprehensive whistleblower protection. the question isn't then whether there are federal statutes protecting whistleblowers; it is whether they are effective. c. state whistleblower laws do not protect most medical researchers most states provide some kind of legal protection to their employees who disclose waste, fraud, or abuse in govemment.280 thirty-nine states have whistleblower statutes that provide general whistleblower protection to public employees; twenty-three states provide general protection for all employees; and, fourteen states provide specific protection to persons re­ porting certain environmental misconduct.281 the literature describing the flaws of this existing system, usually called a patchwork, is extensive. the failure of the existing statutes comes from their misplaced emphasis on the employment status of the whistleblower rather than the potential danger to the public if the potential whistle blower does not feel safe disclosing what she knows. for example, most whistleblower laws protect only those indi­ viduals who have disclosed information exactly in the manner described by the statute. an individual with knowledge of a danger to the public's health or safety may find herself fired because she reported it to her direct supervi278. whistleb/ower protections, u.s. dep't labor, http://www.dol.gov/compliance/ laws/comp-whistleblower.htm (last visited nov. 15, 2011). 279. whistleblower protections, u.s. dep't labor, http://www.dol.gov/compliance/ laws/comp-whistleblower.htm (last visited nov. 15, 20 ll ). 280. robert r. kuehn, suppression of environmental science, 30 am. j.l. & med. 2004 333, 356 (2004). 281. id. 66 indiana health law review [vol. 9:1 sor rather than public entity specified by a specific statute. 282 states vary widely both in the terms of who is defined as a whistle­ blower and what protections are available to meet the criteria. these stat­ utes protect researchers working at state universities, but the protection offered them is far from complete. in addition, by definition, statutes in­ tended to protect state employees would not be available for researchers at private universities. for example, a physician overseeing a drug trial at the university of california at berkley will have different protection if he or she reports a dangerous situation involving human protection than one at stanford university who may well be over-seeing a trial ofthe same drug. this lack of consistency is exactly what concerned justice souter in garcetti who wrote, "[t]he current understanding of statutory protection: individuals doing the same sorts of governmental jobs and saying the same sorts of things addressed to civic concerns will get different protection de­ pending on the local, state, or federal jurisdictions that happened to employ them."283 vii. conclusions prescription drugs are a firmly entrenched and highly dangerous fea­ ture of contemporary u.s. culture. the current system of protecting ameri­ cans from the dangers of prescription drugs both while they are being developed and after they are on the market is killing the people the drugs are intended to protect. although the fda has the authority to regulate the research process and to monitor drug safety after approval, it has not exer­ cised its power in a way that adequately protects the public's health. alt­ hough there are dozens if not hundreds of different statutes and regulatory schemes which attempt to encourage those who know of danger to the pub­ lic's health or pocketbook to bring the information forward, none of them provide adequate incentive or protection in what has become the highly fragmented and complex process of drug development. individuals with knowledge might be located out of country or internationally and be em­ ployed by a variety of different entities including government agencies, pharmaceutical companies, and private universities. in light of the many gaps and weaknesses in the current regulatory system, this article has proposed several ways to protect the public's health by providing those with the most knowledge of the process, individuals in­ volved directly in research and development regardless of whether they are employed by public or private employers, with a method of bringing infor282. see gerard sinzdak, an analysis of current whistleblower laws: defending a more flexible approach to reporting requirements, 96 cal. l. rev. 1633, at 1644-50 (pre­ senting four case studies of how "rigid report recipient requirements" frustrate the intent to protect individuals with knowledge of serious dangers). 283. garcetti v. ceballos, 547 u.s. 410,441 (u.s. 2006) (souter, j., dissenting). 2012] whistleblower protection for medical researchers 67 mation directly to the fda's attention with protection against retaliation. primarily this article proposes that companies seeking the fda's approval to test or market a new drug in the united states must certify that they have in place a mechanism for those with knowledge to bring information for­ ward to the fda without fear of retaliation. any effort to reform a process that has not previously been subject to comprehensive regulation raises many significant normative and logistical problems. it will be necessary for law and policy makers to consider how protection of the public's health is to be weighed against the interest of re­ search institutions and the pharmaceutical companies, which together de­ velop and profit from the relative lack of regulation over the sale and advertising of prescription drugs in the united states. as the u.s. popula­ tion ages and becomes even more reliant on the safety and efficacy of pre­ scription drugs, we cannot simply sit back and let the inadequate and ineffective legal system of regulation continue as it has, but rather we must find a way to provide better protection for those who voluntarily agree to test new drugs as well as those who will someday depend on them for sur­ vival. new technology and increased globalization: addressing difficulties presented in the current fda inspection process new technology and increased globalization: addressing difficulties presented in the current fda inspection process james b. banister* i. introduction ............................ ...... 751 a. food and drug administration history ... ..... 754 b. inspection process ............................ 757 c regulations .......................... ..... 758 ii. analysis ....................................... 761 a. globalization..............................763 b. industry technology.. ........................ 765 c fda ' response to globalization and evolving technology. .......................... ..... 772 iii. recommendations ........................ ..... 777 a. the two parts of a routine inspection .... ..... 778 b. separation ofinspection components ..... .... 782 c creation of fda hubs.. .................... 784 d. onsite inspection strategy..... ............ 787 iv. conclusion .................................... 789 i. introduction christmas music played slowly in the background of a toledo, ohio hospital. under the wistful drone of the music, leroy hubley stood next the bed of his wife bonnie. christmas music must have been present on many special occasions for leroy and bonnie; their kids opening presents, special family dinners, and perhaps happy trips in the car to visit relatives. but on this day, christmas music marked the setting for the most somber of occasions. leroy and his family were saying goodbye to bonnie for the last time. * j.d. candidate, 2014 indiana university robert h. mckinney school of law; b.a., 2004, bob jones university, biology; pharmaceutical microbiologist. indiana health law review shortly after goodbyes and last kisses, bonnie's breathing tube was removed and her pain shortly subsided. in a cruel twist, leroy's seemingly unbearable grief was far from over. only a few weeks later, leroy's son, randy, died in the same manner.' randy and bonnie hubley suffered from a genetic kidney disease.2 as a result of the disease, they routinely underwent dialysis. while not ideal, the disease was manageable with the correct medications and routine dialysis treatments. the tragedy leroy hubley experienced was not caused by a change in prognosis or an advancement of this genetic disease. bonnie and randy hubley died because their life sustaining medication was contaminated. 3 approximately eighty-one deaths, including bonnie and randy hubley, were the result of contaminated heparin produced by baxter international during 2007 and 2008.4 heparin is an anti-clotting prescription drug that is administered intravenously to help avoid blood clots. heparin prevents blood clotting in patients undergoing open heart surgery, kidney dialysis, and a number of other serious surgeries or medical treatments.5 baxter international used contaminated raw ingredients obtained from a chinese manufacturer to produce the heparin that ultimately ended randy and bonnie's lives.6 as a result of the incident, the u.s. food and drug administration ("fda") was criticized for failing to prevent the tainted medicine from reaching the market. the fda was forced to admit it failed to follow its own policies in 1 randolph schmid, familes of contaminated heparin victims tell stories of deaths, usa today (apr. 29, 2008), http://www.usatoday.com/news/health/2008-04-29-3953029109_x.htm. 2 id 3 id. 4 justin blum, china and us. clash over cause of heparin deaths (update 6), bloomberg (apr. 21, 2008), http://www.bloomberg.com/apps/ news?pid-newsarchive&sid=auae9vn4.xxo&refer-home. 5 heparin (intravenous route, subcutaneous rout), mayoclinic.com, http://www.mayoclinic.com/health/drug-information/ dr601931 (last visited oct. 03, 2012). 6 blum, supra note 4. vol. 11:2752 new technology and increased globalization regards to inspection of manufacturing plants.7 the fda had never inspected the chinese factory responsible for producing the tainted ingredient. the 2008 heparin tragedy forced the fda to reassess current strategies and engage in a more active role monitoring overseas manufacturing facilities.8 unfortunately, the heparin tragedy has not been an isolated occurrence in recent years. several other similar incidents have transpired over the past few years. the fda referenced several alarming occurrences in the 2011 pathway to global product safety and quality report: vegetable protein tainted with melonin killed many pets in the united states,9 counterfeit glucose monitoring test strips,' 0 diethylene glycol tainted glycerin," and titanium of low quality intended for medical implants.12 in 2012, a fungal meningitis outbreak in eighteen states occurred as a result of contaminated steroid shots manufactured at a compounding pharmacy in massachusetts. 13 the tainted shots caused hundreds of infections and at least twentynine deaths.14 7 gardiner harris, tainted drugs put focus on the fd.a new york times (mar. 17, 2008), http://www.nytimes.com/2008/03/17/health/ policy/17fda.html?_r-0. 8 fda adopts new strategies to oversee global economy, pharmaceutical tech., http://www.pharmtech.com/pharmtechfregulatory +corner/fda-adopts-new-strategies-to-oversee-globaleconom/article standard/article/detail/781206?contextcategoryld=48564 (last visited october 3, 2012). 9 u.s. food and drug administration, pathway to global product safety and quality (2011) available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofglobalreg ulatoryoperationsandpolicy/globa]productpathway/ucm262528.pdf. 10 id 11 id 12 id 13 13,000 received potentially tainted steroid shots, risk remains uncertain, fox news (oct. 09, 2012), http://www.foxnews.com/healthl2012/ 10/09/1 30 0 0 -received-potentially-tainted-steroid-shots-risk-remainsuncertain/. 14 meingitis outbreak-' 368 cases, 29 deaths, sydney lupkin, abc news (oct. 31, 2012), http://abcnews.go.com/health/wellness/ meningitisoutbreak-368-cases-29-deathsstory?id=17609742. 2014 753 indiana health law review a. food and drug administration history the united states government's regulation of food and drugs can be traced back to 1862 when president abraham lincoln appointed charles m. wetherill to serve in the newly created department of agriculture.' 5 wetherill served in the bureau of chemistry which was the predecessor to the food and drug administration.1 6 since wetherill's appointment, congress has passed a series of laws designed to ensure the safety of u.s. food and drugs. food and drug safety statutes have included: the tea importation act in 1897, the biologics control act in 1902 (the result of children receiving tainted vaccines),17 the original food and drugs act in 1906, the meat inspection act in 1906, the gould amendment in 1913, the harrison narcotic act in 1914, and the mcnary-mapes amendment in 1930.18 however, it was not until 1938 that congress enacted legislation with expansive regulatory enforcement power. in 1938, congress enacted the federal food, drug, and cosmetic act ("ffdca").19 similar bills were previously introduced but were quickly scuttled by industrial interest groups. however, in 1937 s.e. massengill co. of bristol, tennessee marketed a tainted serum that resulted in the deaths of nearly 100 people. 20 the tragedy pushed congress into action and the ffdca was passed. from the time of the ffdca's passage in 1938, the fda was primarily concerned with adulterated food and ineffective medications. 21 15 signidcant dates in us. food and drug law history, u.s. food and drug administration, http://www.fda.gov/aboutfda/ whatwedofhistory/milestones/ucml28305.htm (last updated mar. 25, 2014). 16 id 17 sharon b. jacobs, crises, congress, and cognitive biases: a critical examination of food and drug legislation in the united states, 64 food & drug l.j. 599, 601 (2009). 18 significant dates, supra note 15. 19 id. 20 jacobs, supra note 17, at 602-06. 21 id. at 599 vol. 11:2754 2014 new technology and increased globalization the food and drug act of 1938 contained many provisions that significantly expanded the regulatory role of the federal government in the food and drug industry. some of the more notable provisions include: the authority to regulate cosmetics and therapeutic devices, 22 a requirement that new drugs be proven safe before marketing is allowed,23 removing the requirement to show intent to defraud in drug misbranding cases,24 and implementation of standards for the identity and quality of food. 25 the statute also included the authority to inspect factories as well as quarantine drugs that did not conform to good manufacturing practices. 26 section 374(a) of the food and drug act provides: for purposes of enforcement of this act, officers or employees duly designated by the secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.27 22 significant dates, supra note 15. 23 id 24 id. 25 id 26 id 27 21 u.s.c § 374(a) (2014). 755 indiana health law review in 1962, congress amended the 1938 act to "bring about better, safer medicine and to establish a more effective system of enforcement of the drug laws."2 8 the amendment to ffdca was largely driven by increased drug safety scrutiny following a large number of birth defects in europe caused by a thalidomide compound marketed by a german company, gruenenthal.29 fortunately, the fda prevented the gruenenthal drug from being marketed in the united states due to diligent fda agents, but some industry researchers claimed the thalidomide compound would have been compliant with the current u.s. drug laws. the extraordinary efforts of the fda agents were the only reason the compound did not reach the u.s. market. proponents of revising the ffdca in order to expand the fda's regulatory authority latched onto these findings and used them to leverage the passage of an amendment. 30 the 1962 amendment required any facility manufacturing or processing drugs to be registered with the department of health, education, and welfare (the precursor to the department of health and human services).31 additionally, the amendment strengthened the fda's inspection authority.32 the 1962 amendment defined a drug as "adulterated" if it is not manufactured in conformance with "good manufacturing practices." 33 following the 1962 amendment, congress took actions that affect the role of the fda on several occasions. the infant formula act, intended to establish minimum nutrient requirements for infant formula and define adulteration, was passed in 1980.34 additionally, the food and drug administration amendments act was passed in 2007 ("fdaaa").35 however, as a general rule, the 28 jacobs, supra note 17, at 608. 29 id. at 608-09 30 id. at 609-10 31 id. 32 id. 33 freddy a. jimenez, enforcement of the current good manufactuing practices for solid oral dosage forms after united states v barr laboratories, 52 food & drug l.j. 67, 67 (1997). 34 jacobs, supra note 17, at 612. 35 jacobs, supra note 17, at 612. 756 vol. 11:2 new technology and increased globalization foundation of the fda's current system of inspection is based in the 1938 ffdca and has expanded through statutory enactment over the years. b. inspection process the 1938 act authorized the federal government to inspect manufacturers or processors of products that fall under the regulatory scope of the fda. 3 6 some examples of industries which fall under the inspection authority include: vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, and animal feed processors. 37 additionally, the federal government inspects the following: facilities that conduct studies in people, such as clinical trials; laboratories that conduct studies in animals or microorganisms when the studies are used to apply for fda approval of a medical product; foreign manufacturers and processors that sell fda regulated products in the united states; and imported products at the border. 38 under the authority of the 1938 act, the fda currently conducts several types of inspections of drug product manufacturers. 3 9 the fda conducts pre-approval inspections ("pai") upon submission of a new product application, including new drug applications, biological licensing application, or abbreviated new drug application.40 if a manufacturer intends to market a drug product, it must first gain approval of the manufacturing facility from the fda. the fda attempts to ensure the manufacturing facility is capable of manufacturing the product in compliance with regulatory expectations. 41 36 what does fda inspect, fda.gov, http://www.fda.gov/ aboutfda/transparency/basics/ucml94888.htm (last updated feb. 12, 2014). 37 id. 38 id 39 id 40 [d 41 see u.s. food & drug admin., compliance program guidance manual, chapter 46 new drug evaluation 2 (2012) available at http://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufa 2014 757 indiana health law review a second type of inspection is the "for cause" inspection. these inspections occur when a specific problem is called to the attention of the fda.4 2 an example of a "for cause" investigation would be an inspection following consumer complaints or adverse reactions to a particular product. the final type of inspection is a routine inspection. these are recurring inspections at facilities that manufacture, process, or hold fda regulated drug products. 43 the purpose of a routine inspection is to ensure continued compliance with manufacturing regulations. the routine inspection process is subsequent to the pai and is intended to prevent the need for a "for cause" inspection. c regulations the requirements for manufacturing fda regulated drug products are known as current good manufacturing practices ("cgmp"). the 1962 amendment to the ffdca established cgmps as the standard by which to inspect fda regulated facilities for compliance. 44 the cgmps are a system of regulations that are intended to "assure proper design, monitoring, and control of manufacturing processes and facilities."45 the purposes of the regulations are to define the necessary quality systems that must be in place for a drug to be consistently manufactured in a safe manner. the fda defines the cgmps as: adherence to the cgmp regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. this cturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmp fordrugs/ucm071871.pdf. 42 what does fda inspect, supra note 36. 43 id. 44 facts about current good manufacturing practices (cgmps), fda.gov, http://www.fda.gov/drugs/developmentapprovalprocess/manu facturing/ucm169105.htm (last updated may 2, 2013). 45 id. 758 vol. 11:2 new technology and increased globalization includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. this formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mixups, deviations, failures, and errors. this assures that drug products meet their quality standards.46 the cgmp regulations are the minimum regulatory requirements. it is not unusual for manufacturers to exceed the basic requirements outlined in the cgmps. 47 the cgmps are broadly written in order to allow individual manufacturers the freedom to establish scientifically sound strategies to comply with the requirements. two different manufacturers may adopt different strategies that are both compliant. for example, cgmps require manufacturers to establish procedures that keep microbiological contamination from entering sterile drug products.48 one manufacturer may establish a process that waits until a drug has been packaged and then irradiates the drug inside the packaging to destroy any microbiological contamination. another manufacturer may have a product that does not allow the irradiation approach so they choose to filter the product to remove any microbiological contamination prior to packaging. both strategies conform to the cgmp requirements but are very divergent as strategies and processes. the cgmps are found in the code of federal regulations ("cfr"). title 21 of the cfr contains the cgmps. some examples of sections from title 21 include: manufacturing, processing, packaging, holding drugs,49 finished 46 ifd 4 id 47 td. 48 21 c.f.r. § 211.113(b) (2014). 49 21 c.f.r. § 210, 225, 226 (2014). 2014 759 indiana health law review pharmaceuticals (products such as heparin from baxter international),50 medicated feeds,5 1 type a medicated articles, 52 and blood components. 53 the cgmp regulations outline the fda's expectations of manufacturers in many areas. one area in which the cgmps require compliance is documentation. there are cgmp requirements regarding how the data generated in the manufacturing process is to be documented and retained. there are also requirements for equipment and process validation. validation is the documented evidence that a piece of equipment or a process achieves the intended results. additionally, the cgmps establish requirements for the manufacturing facility itself. the facility must be capable of maintaining certain levels of cleanliness. other requirements call for personnel to be appropriately trained for the tasks they will be performing and the training to be documented. standard operating procedures ("sop") must be in place and managed in an appropriate manner. there must be a system in place to track errors and how the company corrects and prevents errors from reoccurring in the future. the company also must conduct self audits to ensure compliance. these are just a few of the requirements the cgmps require of drug product manufacturers. 54 the small "c" that begins the acronym "cgmp" stands for "current." this word is important because it allows each manufacturer the flexibility to establish his or her own scientifically sound strategies for manufacturing andlor processing drug products.5 5 "current" is necessary because technology is always evolving and strategies that may have been compliant with the cgmps ten years ago may no 50 21 c.f.r. § 211 (2014). 51 21 c.f.r. § 225 (2014). 52 21 c.f.r. § 226 (2014). 53 21 c.f.r. § 606 (2014). 5 center for cell and gene therapy, the emmes corp., introduction to gmp & gtp 11, available at, https://secure.emmes.com/ pactweb/system/files/gmp-gtptraining-022007.pdf. 55 facts about current good manufacturing practices (cgmps), supra note 44. 760 vol. 11:2 2014 new technology and increased globalization longer be compliant today.56 current good manufacturing practices vary in the amount of guidance given to manufacturers; the more risk a certain process presents to consumers, the more government oversight exists.57 ii. analysis based on the historical expansion of the fda's regulatory powers and the current regulations (cgmps), it would seem the fda has the necessary authority to prevent incidents like baxter's tainted heparin from occurring. however, the incident did occur despite the fda's regulatory powers and current inspection scheme. additionally, the reoccurrence of similar issues, such as the 2012 meningitis outbreak as a result of tainted steroid shots prompts the question, "what is hampering the fda's effectiveness and how can it be improved?" the fda is in a very difficult position because it receives little credit for the effective measures already in place that have prevented contaminated medication from reaching the marketplace but receives much of the blame when incidents such as baxter's heparin occur. however, given the consequences that occur when the fda does fail, the criticisms are arguably fair. in this author's opinion, the most effective preventative step the fda has at its disposal, to protect consumers from contaminated products, is "routine" inspections. "for cause" inspections are reactive. a "for cause" inspection is not conducted until after a problem has been identified. of course, a "for cause" inspection may prevent the problem from being exacerbated or future issues from occurring, but generally there must be a problem before that type of inspection occurs. drug pre-approval inspections ("pa") are vitally important, but may not be as accurate a reflection of the manufacturing process as a routine 56 id. 57 jill wechsler, pharmaceutical tech., fda moves to implement new gmp policies 36 (2004), available at http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech452 004/132382/article.pdf. 761 indiana health law review inspection. manufacturers have prepared for the inspection and know what will be expected. going into a preapproval inspection, the "i's" are dotted and "t's" crossed. a "routine" inspection is generally unannounced and results in a more accurate reflection of the day-to-day manufacturing process. additionally, a routine inspection differs from a pai because it allows inspectors to track data over longer periods of time for potential negative trends or failure to properly correct errors that have occurred. the fda must effectively use its routine factory inspection process to protect u.s. consumers. however, the fda does not have the resources to inspect every product that makes it to the consumer.55 this would be logistically impossible. given this reality, foods, cosmetics, and medicines must be organized on a continuum of risk to patients based on intrinsic characteristics of the products.5 9 for many products that fall under the purview of the fda, the risk of harm to people is mitigated by the presence of natural human defenses. the body has physical barriers that prevent bacteria, viruses, and pathogens from causing sickness and infection.60 the immune system, skin, tears, mucus, cilia, stomach acid, and natural occurring microflora all help prevent infection. 6 1 these physical barriers many times offset the danger of contaminated food or cosmetics. 62 typically, only people with compromised or underdeveloped immune systems, such as the elderly or children, are impacted by contaminated food or cosmetics. 63 the highest risk to u.s. consumers is either from drug products that contain toxins that will adversely affect the body, despite 58 u.s. food and drug administration, supra note 9. 59 wechsler, supra note 57. 60 immune system, 1vicrobiology online, http://www. microbiologyonline.org.uk/about-microbiology/microbes-and-the-humanbodylimmune-system (last visited april 9, 2014). 61 id 62 id 63 stephanie armour et al, food sickens mions as company-paid checks find it safe, bloomberg markets (oct. 11, 2012), http://www. bloomberg.com/news/2012-10-11/food-sickens-millions-as-industry-paidinspectors-find-it-safe.html. 762 vol. 11:2 new technology and increased globalization the body's physical defenses, or drug products that bypass the body's natural defenses such as injectibles. when these types of high risk drug products are manufactured incorrectly, incidents such as the 2008 heparin outbreak and 2012 steroid meningitis outbreak can result. heparin and steroid shots are drug products that are injected directly into the patient's blood stream or muscle tissue, bypassing the body's physical defenses. if injectable drug products contain even a trace amount of contamination, serious repercussions are usually to be expected. as a result, manufacturing these medications is a very complicated and expensive process. due to these risk factors, and a realization that the fda has finite resources, the fda has a strategy of concentrating more resources towards oversight, such as inspections, of manufacturers that produce high-risk goods, such as injectable medicines.64 despite the fda's increasing regulatory power over the years, as well as its risk-based approach, this author believes certain trends have made it increasingly difficult for the fda to regulate the industry and protect consumers. these trends include increased globalization of, and quickly evolving technology for, high-risk product manufacturing. these trends have created barriers to fda inspections by increasing the jurisdiction the fda must inspect and the depth of knowledge the inspectors must attain. a. globalization traditionally, pharmaceutical companies were highly centralized, and conducted the entire process of drug development, from research through manufacturing, domestically.65 however, "[gllobal production of fdaregulated goods has exploded over the past ten years. in addition to an increase in imported finished products, 64 wechsler, supra note 57; u.s. food and drug administration, supra note 9. 65 rachna pande, globalization of biopharmaceutical manufacturing 15 (sept. 2011) (unpublished s.m. thesis massachusetts institute of technology) (on file with author). 2014 763 indiana health law review manufacturers increasingly use imported materials and ingredients in their u.s. production facilities, making the distinction between domestic. and imported products obsolete."66 some estimates predict importation of fda regulated goods will triple between 2007 and 2015 (a 15% annual growth rate).67 from 2007 to 2011 fda regulated shipments from china increased from 1.3 million to 2.1 million annually.6 8 the number of foreign facilities making fda regulated drugs has doubled between 2001 and 2007 (1282 2820).69 of the 2.1 million fda regulated imports from china, 30% were drugs or medical devices (630,000).70 new manufacturing facilities in china and india make up more than 40% of fda-registered foreign pharmaceutical locations.7 1 supply chains are becoming increasingly globalized and complex. 72 additionally, increasing populations throughout the globe have resulted in increased demand in new markets for drug products. this new demand is one of the drivers for increased globalization in the food and drug industry manufacturing. increased demand also presents a new challenge for the fda because drug seizures or manufacturer closures may result in drug shortages worldwide. drug shortages in the united states alone rose from 61 incidents in 2005, to 178 incidents in 2010.73 in addition to the challenges of regulating a quickly globalized industry, the fda now also feels the pressure to keep the "presses rolling" by not closing manufacturing facilities. the fda is in the unenviable spot of attempting to regulate 66 fda unveils new global strategy to help ensure safety and quality ofimported products, u.s. food and drug admin. (june 20, 2011), http://www.fda.gov/newsevents/newsroomfpressannouncements/2011/ucm 259848.htm. 67 fda fact sheet: increasing fda capacity in china, fda.gov, http://www.fda.gov/internationalprograms/fdabeyondourbordersforeign offices/ucm291754.htm (last updated feb. 13, 2012). 68 id 69 pande, supra note 66, at 18. 70 fda fact sheet, supra note 68. 71 pande, supra note 66, at 19. 72 fda fact sheet, supra note 68. 73 pande, supra note 66, at 19. 764 vol. 11:2 2014 new technology and increased globalization food and drug products perfectly and without any similar instances as the problem with baxter heparin, while at the same time not causing drug shortages in the process. given this global trend, the fda is facing a global regulatory challenge that requires new and creative approaches to maximize resources and increase regulatory effectiveness. increased globalization is a challenge for the fda's inspection process because it has expanded the area in which regulated products are marketed. fifty years ago, the fda could inspect a factory and see the entire process, cradle to grave, in one location. today, the manufacturing process may occur over several continents, as was the case for the baxter heparin.74 as a result, the number of facilities the fda is required to inspect has significantly increased. b. industry technology manufacturing of high risk drug products such as injectable drugs occurs in "clean rooms." microbe-free clean rooms were first used in hospital settings in the late 1800's when there was increasing knowledge that bacteria caused surgical infections.75 the first hospital clean room sprayed carbolic acid (phenol) into the air, and onto the surgeon's hands and tools to eliminate bacteria. 76 throughout the early 1900's, more advances were made in aseptic gowning techniques for surgeons.77 in 1961, charnley and howorth invented a "greenhouse" to provide clean, unidirectional air over a surgical operating table.78 charnley and howorth also improved the design of fabric and clothing used in the "greenhouse" to prevent the dispersion of microbes.79 as a result of charnley and howorth's discoveries, infections 74 walt bogdanich, fd.a tracked poisoned drugs, but trail went cold in china, n.y. times (june 17, 2007), http://www.nytimes.com/ 2007/06/17/ health/17poison.html?_r-2&. 75 william whyte, cleanroom technology: fundamentals of design, testing and operation 12 (2d ed. 2010). 76 id 77 id. at 14. 78 id. at 17. 79 id. at 18. 765 indiana health law review during hip replacement surgeries, which used the "greenhouse," went from 10% to less than 1%.80 industrial clean rooms were first established to improve manufacturing quality of gun, tank, and aircraft components during wwii.81 these rooms used nonshedding materials such as stainless steel for manufacturing. 82 research relating to nuclear fission, biological weapons and chemical weapons drove the invention of high efficiency particulate air ("hepa") filters. 83 these filters allowed extremely clean air to be showered over the area in which critical manufacturing was occurring. the first room which put together all the components for microbial cleanliness was a western electric factory in north carolina which built missile gyroscopes. the personnel wore non-shedding clothing; the room was built of materials that were non-shedding and easily cleanable; and the air was filtered through hepa filters. 84 this strategy remains the current strategy in most fda regulated clean rooms. after the western electric clean room, the next pivotal moment for clean rooms came in 1960 when willis whitfied organized a bank of hepa filters that supplied air that flowed in a laminar direction.8 5 laminar (unidirectional) airflow creates a blanket of clean air that protects whatever is being processed within the area. much of the history of clean rooms is embodied in the cgmp regulations, and as such, is a standard by which the fda measures manufacturer compliance. the fda's expectation is that manufacturing of high risk drugs such as injectables be done in a clean room where microbial contamination is controlled (see image 1). the cgmps do not specifically require all the strategies be employed in clean rooms, but the fda releases guidance to the industry reports which explain the fda's minimum expectations in 80 id 81 id. at 19. 82 id. at 20. 83 id 8 id. at 21. 85 id. at 20. vol. 11:2766 new technology and increased globalization manufacturing facilities (informal rules). the fda cites other guidance documents such as the international standards organization (iso) standards in their guidance to the industry for establishing the clean room expectations when manufacturing. 86 image 1: traditional clean room87 however, new forms of equipment have allowed the industry to move away from the traditional "clean room" manufacturing strategy that the fda has established as an expectation. modern technology has allowed computers and machines to perform some of the roles previously conducted manually by humans (the greatest source of contamination in clean rooms). equipment such as depyrogenation tunnels, automatic lyophilizer loading systems, clean-inplace/sterilization-in-place systems, and automated check/adjustment systems all reduce the human interaction 86 u.s. dep't of health & human serv. et al., guidance for industry: sterile drug products produced by aseptic processing current good 'manufacturing practice, 5, (2004), available at http://www.fda.gov/downloads/drugs/ .../guidances/ucm070342.pdf. 87 medical, advaltech, http://www.styner-bienz.com/group/mediainfo/ picture-archive/marketsproducts/medical.html (last visited jan. 11, 2013). 2014 767 indiana health law review within the manufacturing environment.88 each of these automated pieces of equipment has subject matter experts employed by manufacturers to ensure the equipment is functioning properly and doing the job as intended. however, the fda does not have the resources to inspect every facility with a similar subject matter expert for each piece of equipment. the automated equipment results in a better process, but a process that is much more complex and has to meet increased regulatory requirements such as computer system validations. this presents a challenge to the fda's current inspection scheme by requiring inspectors to gain a much broader base of knowledge to properly inspect a manufacturer. some other examples of trends in manufacturing equipment that are different from the traditional manufacturing practices include isolators and restricted access barriers. isolators are closed systems in which a bank of hepa filters supplies air within a rigid walled "box" (see image 2). all of the critical drug manufacturing steps occur within this "clean box." the only human interaction occurs through permanently mounted gloves that are accessed from the outside of the box. the advantage is the elimination of human interaction within the manufacturing areas. however, because there is no human interaction, there is an increase in automation and computer controlled systems. this results in a much more complex validation, complex sops, and complex quality systems. an inspector inspecting the facility must understand all of this complexity. 88 james akers & james p. agalloco, clean rooms, rabs and isolators: validation and monitoring in the diverse world of aseptic processing, am. pharmaceutical rev., may/june 2011 available at http://www.americanpharmaceuticalreview.com/featured-articles/36878clean-rooms-rabs-and-isolators-validation-and-monitoring-in-thediverse-world-of-aseptic-processing/. 768 vol. 11:2 2014 new technology and increased globalization image 2: aseptic isolator8 9 an intermediary between the isolator and the clean room is the restricted access barrier (see image 3). this system creates a containment box, which can be opened in some situations in order to perform manual manipulations. once again, this is a challenge for an inspector. if a facility utilizes either an isolator or a restricted access barrier to manufacture drug products, the inspector must fully understand the requirements of, and differences in, each form of technology. 89 skan ag, isolator technology, pharmaceutical int'l, (april 7, 2007, 12:33 pm), http://www.pharmaceutical-int.com/article/isolatortechnology.html. 769 indiana health law review image 3: restricted access barrier 90 additionally, new modes of medicine delivery are becoming more and more prominent. traditionally, aseptic medicine was packaged in an ampoule from which the doctor would use a syringe to extract the medicine. ampoules evolved into vials, and now, direct injection pens and pre-dosed cartridges are the trend. ' methods of analyzing data are evolving in the manufacturing industry as well. recently the united states pharmacopeia ("usp"), a non-profit publication that provides guidance to the industry by establishing documentary and reference standards for medicine, revised chapter 1116. chapter 1116 is titled "microbiological control and monitoring of aseptic processing environments." the chapter gives guidance on how manufacturers of high risk medication should monitor for microbiological contamination in clean rooms. historically, 1116 set numerical limits on how much contamination could be recovered in clean rooms while still being considered in a state of control. however, the revised chapter advises a more holistic approach where recovery of microbiological 90 news & events, romaco, http://www.romaco.com/gb/news/ artikellnews/the-vf-18-aseptic-liquid-filling-machine.html (last visited jan. 11, 2013). vol. 11:2770 2014 new technology and increased globalization contamination is analyzed for negative trends rather than discrete occurrences. the fda relies heavily on the usp when inspecting factories. shifts in usp recommendations create new quality strategies in the industry. this requires additional knowledge and flexibility on the part of inspectors. new methods of collecting data are also emerging. the traditional method of determining whether or not microbial contamination is present requires exposing a petri dish with an appropriate medium, such as trypticase soy agar, to the desired environment over a given period of time.91 the medium provides nutrients to any bacteria that fall onto the surface of the petri dish. after several days of incubation, bacteria on the surface of the petri dish will grow to a point where visible. a microbiologist will count the number of bacterial "colonies" and compare it to the allowable amount of contamination for the area to determine if the area was sufficiently clean during manufacturing activities. this approach is effective but time consuming. this method only reveals contamination several days after manufacturing has occurred. new technology has recently been emerging that yields instant analysis of microbial contamination. one technology (of many that are being developed) uses an enzyme found in lightning bugs to create a chemical reaction when proteins from bacteria are present on a given surface. the tool measures the amount of light released in the chemical reaction and reports the results instantly. while this technology is still in its infancy, it could revolutionize the way manufacturers analyze the cleanliness of their facility. another example of new technology that may revolutionize data collection is azbil's biovigilant system. this system instantly detects both nonviable and viable particles using lasers and bioluminescence. 92 the current guidance from the fda 91 limitations of traditional microbiological methods, ehow, http://www.ehow.com/info_8616775_limitations-traditional-microbiologymethods.html (last visited april 11, 2014). 92 azbil biovigilant's instantaneous mcrobial detection system, http://www.youtube.com/watch?v-i_2wbbfrif24 (last visited feb. 05, 2013). 771 indiana health law review assumes the use of the traditional methods of microbial recovery. if a company invests in new technology, such as biovigilant, there is no guidance to indicate what results would be deemed acceptable for a clean room environment. these new technologies are just one example of the complexity an fda inspector must adapt to when conducting an inspection. new methods and technology are constantly emerging and the fda must determine if it meets the intent of the cgmps. these determinations require technical knowledge in multiple areas. all of the examples of evolving technology present increased responsibilities for the fda. this evolution and constant change requires the agency to be ahead of the curve and make regulatory decisions quickly in order to provide stability to the industry. the fda hires exceptionally talented and bright individuals as inspectors. however, manufacturers employ subject matter experts in many different areas such as microbiology, engineering, validation, chemistry, etc. the fda inspectors must understand the nuanced approaches each of these areas employs and determine if the strategy is sound and compliant with the regulatory requirements. this is a challenging task even for the sharpest inspector. modern technology that is being utilized in sterile manufacturing is consistent with the "c" in cgmps. it is producing a cleaner way of making medicine. however, it poses a challenge for the fda because it makes ensuring compliance harder. complex systems require complex software, validations, cleaning, etc. the fda must assess the current inspection scheme to maximize the specific talents of each inspector. c. fda's response to globalization and evolving technology the fda is not blind to the challenges it is facing. the agency has taken steps to address both increased globalization and the difficulty in regulating new technology and evolving processes. 772 vol. 11:2 2014 new technology and increased globalization between 2007 and 2009, foreign manufacturing plant inspections have increased from 333 to 424.93 the fda has collaborated with other regulatory agencies around the globe by working on harmonizing regulations. the pharmaceutical inspection cooperation/scheme (pic/s) is an informal organization of drug manufacturing inspectorates from 39 different countries. 94 the fda obtained full pic/s membership in 2010.95 the goal of the pic/s organization is to develop and disseminate consistent cgmp standards. 96 this will result in manufacturers being held to the same standards regardless of where the manufacturing occurs. currently, regulations in china may differ from standards in the united states or europe. this creates difficulty for manufacturers as well as inspectors. the fda has moved to eliminate this hurdle by joining pic/s. additionally, the global harmonization task force ("ghtf") was created to provide a forum for medical device manufacturers.9 7 the fda is assembling global coalitions of regulators.98 this strategy will provide global data information systems and networks so regulators worldwide can more easily collaborate in real time.99 the fda is attempting to modernize its it capabilities, allowing easier communication and interaction with global manufacturers. 0 0 the fda is also allocating agency resources on a risk based model.10 1 this allows the fda to focus more resources on higher risk products. 93 u.s. food & drug admin., supra note 9. 94 id. at 19. 95 thomas peither, fda will obtain full pic/s membership in 2010, maas & peither ag gmp publishing (2010), at 1, available at http://www.picscheme.org/bo/commun/upload/document/article-on-us-fdapdf.pdf. 96 id 9 u.s. food & drug admin., supra note 9. 98 id. at 24. 99 id. 100 id. at 20. 101 id. 773 indiana health law review in 2011, the fda food safety modernization act was enacted.102 under the act, importers now have the explicit responsibility to ensure the source of the imports have sufficient quality system controls in place.103 this places the onus on the manufacturers to control their third party manufacturers that may be located outside of the united states. additionally, the agency can now certify a third party system for inspecting foreign supplies of food, freeing agency resources.104 this strategy is based on the risk model, that food products are generally lower risk than medicines, and therefore third parties can adequately verify the producers. arrangements with foreign governments that leverage their resources are encouraged as well. 05 despite these improvements to the fda strategy, the fda cannot keep up with the trend in globalization. it would take approximately nine years for the fda to inspect every high risk drug manufacturing facility just one time.106 it is expensive to inspect foreign facilities. the average cost of inspecting a domestic facility is approximately $23,000 while the cost of inspecting a foreign facility is approximately $52,000.107 the fda has also implemented changes to account for rapidly evolving technology in the industry. in 2002, the fda announced a new program called the pharmaceutical current good manufacturing practices for the 21st century. 08 the new program was intended to modernize the cgmp regulations to account for new technology and practices. the new program encouraged manufacturers to use scientific rationale to create risk-based quality systems.109 additionally, as a response to increasingly complex manufacturing processes and technology, the fda 102 id. 103 id. 104 id. 105 id. 106 id. 107 pande, supra note 66, at 19. 108 u.s. food and drug administration, compliance program guidance manual, supra note 41. 109 id. 774 vol. 11:2 new technology and increased globalization developed the pharmaceutical inspectorate (pi). certification for the program began in 1994.110 the program was initiated as a response to the industry asking for more consistency in the inspection process."' the program establishes three levels of certification for drug inspectors. level i inspectors are newly hired inspectors, and certification requires intensive classroom training.112 level ii inspectors require more in-depth knowledge of active pharmaceutical ingredient manufacturing, computer systems validation, industrial sterilizations, and drug manufacturing/quality control.113 the preeminent level is level iii. these inspectors comprise the pharmaceutical inspectorate.114 eligibility to become part of the pharmaceutical inspectorate is based on a minimum of three years inspecting drug manufacturers, certification as a level ii, endorsement by management, and selection or nomination by the level iii certification board.115 the pi spends approximately 80% of his or her time participating in foreign and domestic drug inspections." 6 level iii certified investigators are expected to be competent in the latest regulatory programs and procedures as well as technology.117 level iii certified investigators are also expected to develop and implement formal training for fda, industry, and state/local officials." 8 additionally, there are many forums for the industry to present new strategies and receive feedback from regulatory agencies. this allows the fda to stay up-to-date on the latest industry strategies and provide regulatory feedback. the pharmaceutical drug association ("pda") hosts conferences in which many of the newest technological 110 rick perliian, what's new in the fda's pharmaceutical inspectorate and risk based systems inspection, asq (2006), available at asq.org/fdcevents/ppt/200604-golden-gate-section-conference.ppt. 111 id 112 id 113 id 114 id 115 id 116 id 117 id 118 id 2014 775 indiana health law review advances and strategies are presented. the fda regularly attends and provides input to the industry. finally, the fda has created several committees to advise the agency as well as the industry in regards to drug safety trends and strategies. in 2002, the drug safety and risk management advisory committee was formed. the committee is made up of experts in science as well as risk management. the committee "advises the commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use."119 the fda also created the drug safety oversight board. members of the board are comprised of fda personnel as well as other governmental agencies. the board's purpose is to advise the fda "on the handling and communicating of important and often emerging drug safety issues" and to provide "a forum for discussion and input about how to address potential drug safety issues."120 beyond the difficulty faced by the fda and other regulators, globalization and new technology has also presented challenges for the industry as they seek to manufacture goods that are compliant with cgmp regulations. one of the difficulties faced by manufacturers is that inspectors with technical expertise in a specific field are responsible for inspecting every aspect of a facility. this results in potential regulatory enforcement actions based on incomplete background knowledge of the particular area that is being assessed. additionally, quickly evolving technology has created a multitude of strategies and it is difficult to know regulatory expectations until an inspection occurs. finally, many manufacturers sell products globally; as a result, they must comply not just with the cfr 119 fda, drug safety and risk management advisory committee charter, food and drug admin. (2012), available at http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/dru gs/drugsafetyandriskmanagementadvisorycommittee/ucm094886.htm. 120 susan thaul, cong. research serv., r41983, how fda approves drugs and regulates their safety and effectiveness 9 (2012) available at http://www.fas.org/sgp/crs/misc/r41983.pdf (quoting drug oversight board, food and drug admin., http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandt obacco/cder/ucu082129.htm (last updated dec. 22, 2010)). 776 vol. 11:2 new technology and increased globalization regulations. companies must interpret the regulations from every country in which they sell products. iii. recommendations based on the challenges facing the fda along with the expectation from the public of perfect enforcement, the agency should consider new strategies for routine inspections that better utilize the agencies resources. the primary driver for safe products is not necessarily the fear of enforcement proceedings from a regulatory agency. manufacturers do consider regulatory compliance vitally important, but the primary driver for any manufacturer is the overall health of the business. if a business manufactures a product that harms consumers, there is little doubt they will falter and perhaps even fail as a business. if a manufacturer is not acting in good faith, there is a strong likelihood that no matter what the current regulatory guidance or inspection strategy entails, consumers will eventually be hurt. the fda recognizes this truth and has indicated the belief that most manufacturers intend to comply with regulations. "a basic precept of fda enforcement policy . . . that a majority of persons desire to comply with the law and will comply voluntarily when given information as what is required and what violations appear to exist."121 for situations where a manufacturer has not acted in good faith, the regulatory reaction must be swift and harsh to dissuade other companies that may consider similar actions in the future. this is the purpose of "for cause" inspections. the incidents that can be avoided are situations where manufacturers desire to comply, but may not have the proper guidance or knowledge to make proper strategy decisions. to provide the best guidance to manufacturers, and at the same time maximize resources, the fda should consider separating a routine inspection into two parts, an onsite portion, as inspections occur now, as well as an online portion. 121 marie a. urban, the fda's poky on seizures, injunctions, civil fines, andrecalls, 47 food & drug l.j. 411 (1992). 2014 777 indiana health law review a. the two parts of a routine inspection a typical routine facility inspection of a high-risk manufacturer, such as injectibles, consists of two parts, document review and facility tours. the document review portion of a routine inspection usually includes the examination of the facilities quality system, or how the manufacturer ensures the medicine is being manufactured safely and correctly. as part of that review, inspectors review raw data during the document review portions of an inspection. the inspector ensures the quality system and data align with the cgmp expectations outlined in the code of federal regulations. the document review portion of the facility inspection is in general very predictable. many of the same documents and strategies as well as certain data are consistently reviewed during document review. this is true regardless of which regulatory body is conducting the inspection, whether it is the fda or a foreign agency such as the european medicines agency. the following paragraphs highlight a few of the subject areas that are typically covered in a routine inspection of a high risk manufacturer. inspectors will ensure the quality system is properly established by verifying a corrective action/ preventative action ("capa") system has been defined and documented. 122 it is not unusual for the capa system to be the first system reviewed during an inspection. 123 capa is an expectation established by the cgmps. 124 a properly established capa system will investigate any failure or deviation in the manufacturing process, correct the failure, and prevent it from reoccurring. preventative actions are also proactive by attempting to predict and prevent similar failures in the future. as part of the capa review, the 122 ken peterson, essential elements of effective capa systems, quality digest (apr. 22, 2008), http://www.qualitydigest.com/inside/fdacompliance-article/essential-elements-effective-capa-systems. 123 id 124 21 c.f.r. § 820.100(a) (2014). 778 vol. 11:2 2014 new technology and increased globalization inspector will ensure the appropriate root causes of the failures or deviations are identified and remediated.125 further, when reviewing the quality system, inspectors will typically review strategies to determine if quality and product information is trended and whether or not trends have been identified. 126 a properly established quality system will communicate data to the capa system in ways that are complete, accurate, and timely.127 inspectors will verify this expectation. other expectations that the inspector will verify in regards to the quality system include: appropriate statistical methods are being utilized for trending quality issues, timelines for approval and execution of corrective and preventative actions follow logical sequences, procedures are followed which establish how to investigate failure or deviations, corrective and preventative actions are effective and verified, corrective and preventative actions are implemented and properly documented, and objective evidence is available to indicate management is actively engaged and notified. 128 in addition to the capa system, inspectors often review several other common areas. media fills are reviewed during the document review portion of an inspection. a media fill is an exercise in which the entire manufacturing process is replicated using a liquid media that encourages bacteria to grow. 129 the medicine containers filled with liquid media go through the entire manufacturing processes and are then incubated to ensure no bacteria were introduced into the containers during the manufacturing process. this process demonstrates the facility has the capability of manufacturing without contaminating the product. media fills are executed on routine intervals to 125 how to prepare for an fda inspection, pathwise, http://www.forumsci.co.il/landau/general/how-to prepare-for anfdainsp ection.pdf. (last visited mar. 5, 2014) [hereinafter 1ma inspection]. 126 id 127 id. 128 id. 129 media fill thals as process simulations m pharmaceutical and biotech manufacturing, rapid microbiology, http://www.rapidmicrobiology .com/test-method/media-fil-trials-as-process-simulations-in-pharmaceuticaland-biotech-manufacturing/ (last visited mar. 5, 2013). 779 indiana health law review continually prove the facility has maintained its ability to manufacture drugs properly.130 batch release strategies are also reviewed during the document review portion of a routine inspection. a batch release strategy ensures all of the necessary steps in the manufacturing process are completed and documented appropriately. every batch of medicine is reviewed to ensure each step in the process was completed correctly within the appropriate time period. batch release strategies are a final check prior to the release of medicine to the market which ensures the medicine is safe. the inspector takes particular interest in any deviation from the routine manufacturing process and analyzes any rationalization the manufacturer may have used to justify releasing the product to the market in those cases. the manufacturing of high risk medicine is a complex process and invariably there will be deviations from the prescribed process. a common example would be someone forgetting to place his or her initials in the appropriate location following the completion of a step in the process. the manufacturer must analyze such discrepancies during the batch review and determine the risk to the product caused by the deviation. if there is no risk to the product, the batch of medicine will likely be released onto the market. however, because a company has a financial interest in determining whether or not there is risk to the product, the fda will typically review these justifications closely. validation of processes and equipment is another area that is typically reviewed during the document review portion of an inspection. validation is the documented evidence that the equipment or process is performing as it is intended. the fda has released specific guidance to manufacturers regarding the expectation of process validation. 131 some process validations that may be reviewed during an inspection of a high-risk manufacturer include the process of making and transporting the bulk 130 id. 131 u.s. dep't of health and human servs. et al., guidance for industry process validation: general principles and practices (2011). 780 vol. 11:2 2014 new technology and increased globalization medicine and the process of cleaning and installing the filling equipment. some examples of other validations that may be reviewed include: filling equipment, cleaning equipment, data collection equipment / systems, computer software systems, the environment inside the manufacturing area, air flow patterns in the critical manufacturing zones, and utility systems such as water, gas, and steam. several other things that may be reviewed include: laboratory testing methods, methods of tracking out of specification data results, systems to check the quality of incoming materials, systems to ensure appropriate packaging and labeling, organizational charts, standard operating procedures, customer complaints, and whether appropriate training is completed for people conducting critical activities. the document review portion of an inspection will also typically involve the review of raw data and any investigations conducted into non-conforming data. this review includes data collected to ensure the manufacturing areas comply with the requirements of cleanliness as well as data around the manufacturing process itself. data review will allow inspectors to verify specific cgmp expectations, such as data integrity, good documentation, facility cleanliness, and utility system control have been met. these are just a few examples of subjects typically covered in the document review portion of the inspection process. the other half of the inspection process typically involves facility and area tours. facility tours allow the inspectors to observe the conditions of the manufacturer's production area. the inspectors will observe whether or not the personnel are acting appropriately, such as moving slowly and deliberately inside clean rooms. the inspectors will be able to observe whether the facility is adequately clean, whether the laboratories have the appropriate equipment to do testing, and any other criteria expected of manufacturers that must be observed in person. 781 indiana health law review b. separation of inspection components the fda can offset the challenges and costs faced by globalization and technology by separating document review audits from facility tour audits. a common thread that runs through all of document review portions of inspections is that all of the information can be inspected from a remote location. evolving technology can be leveraged by the fda to be in constant contact with manufacturers from a centralized location. web based "clouds" allow easy and safe document exchange and online meetings allow face to face interactions from remote locations. collaborative websites could be used for fast, easy, and organized document exchange. an example of how a remote inspection may occur would be to allow the manufacturer to upload strategy documents, validation protocols, and even raw data to a website which they control the access. the fda could be given access, upon notice, to review the requested documents. it might also be possible for the fda to access secured websites and see data streaming in real time. of course, the fda would need to provide notice before accessing the data, but it would allow for efficient, impromptu checks without any of the current travel time and expenses. remote meetings are no longer a concept from science fiction movies. most businesses, especially those that have international suppliers or third party manufacturers, have the capability of conducting remote, online meetings. this technology should be utilized by fda inspectors to meet with manufacturers to discuss strategies and data. remote interaction with the fda is not a novel concept for manufacturers and is not an unreasonable burden upon manufacturers. manufacturers are currently required to interact with the fda for several reasons following the approval to manufacture drugs. in each of these instances the obligation is on the manufacturers to initiate the required interactions. the code of federal regulations requires manufacturers to notify the fda if there are any changes to the agreed terms in the new drug application 782 vol. 11:2 2014 new technology and increased globalization ("nda").132 additionally, manufacturers must notify the fda if they make any changes to labeling on drugs.133 this includes any changes to actual labeling or even promotional material. the manufacturers must also submit an annual report that includes all labels and promotional material that is being utilized for a given product.134 manufacturers must submit any changes to the manufacturing process to the fda for review. 135 under 21 cfr 314.80, the manufacturers are required to report any adverse events that are associated with the use of the manufacturer's drug in humans.136 finally, manufacturers are required to submit an annual report to the fda to summarize any new information regarding the drug to which the manufacturer received nda approval.137 these interactions are typically formal submissions that occur in preapproved formats. for minor changes, an annual report is sufficient and drugs can be marketed without waiting for the annual report to be filed.138 moderate changes require the submission of a cbe-0 or cbe-30 reports.139 marketing is delayed until either the submission of the report or 30 days following the submission.140 major changes require the submission of a prior approval supplement ("pas") change.141 marketing of the drug can only occur following the approval of the report for major changes.142 given the fact that manufacturers currently interact with the fda remotely, it is not too burdensome to additionally require manufacturers to submit to inspections 132 peter barton hut et al., food and drug law 735 (3d ed.2007). 133 id. 134 id. 135 id. 136 id. at 136. 137 id. at 137. 138 arthur b. shaw, drug master files, food and drug admin. 46 http://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucmlo3534. pdf (last visited mar. 5, 2014). 139 id. 140 id. 141 [d 142 [d 783 indiana health law review remotely as well. the current submissions to the fda occur on predetermined forms and typically occur at set frequencies or following changes made by the manufacturer. this allows the process to move deliberately and slowly. this would be different than an inspection that would occur remotely. manufacturers would not have the same amount of time to prepare as they typically do for a submission to the fda. however, it should not be any more of a burden than when an impromptu inspection occurs at the facility itself. c creation of fda hubs beyond remote inspections, and in order to account for rapidly changing technology, the fda should establish specific groups of inspectors to look at subsets of a manufacturer's process in which those inspectors are experts such as pi inspectors. this would be a change from the current strategy of allowing several inspectors to review every aspect of a manufacturer's process. for example, inspectors who have science backgrounds will evaluate the laboratory controls of a company. engineering inspectors will evaluate facility design and equipment validation. it inspectors will inspect the data integrity and computer software systems used by companies. these expert subsets of inspectors can form specific hubs that are centrally located, such as in washington d.c. each hub would be made up of experts in a specific subject area that is required by cgmps. the hubs would allow inspectors to focus on one particular subject area and increase their knowledge base in that field. hubs would help the fda stay up to date on the most current trends in the industry for particular subject areas. hubs would also allow proliferation of strategies that are being utilized by the industry as a whole. proliferation would occur because the inspectors would be very familiar with their particular area of expertise and the various strategies being employed throughout the industry. using remote inspections, the inspectors can either schedule a meeting to ask questions of the manufacturer 784 vol. 11:2 2014 new technology and increased globalization regarding a specific strategy or require the manufacturers to submit strategy documents or data. this strategy would also allow manufacturers to decentralize their response to an inspection. when an inspection occurs, there is typically an entire group of people that put everything on hold to accommodate the inspection. this group includes facilitators which act as hosts for the inspectors and coordinate the logistics of the inspection. 143 additionally, an inspection team will include scribes and runners to write down observations and requests an inspector may have and relay that information to the appropriate parties. 144 subject matter experts are also part of the inspection team. these individuals can speak to specific processes and strategies the manufacturer employs.145 the inspection team also includes control room staff and members of management. 146 rather than have a single group that coordinates an inspection, each individual subject area within the manufacturer would be responsible for coordinating the inspection for their particular area with the fda hub. for example, the manufacturing group that is responsible for assuring the sterility of the facility and processes would interact directly with the fda hub tasked with inspecting sterility assurance strategies. a microbiologist from the fda, in this case, would be interacting with a microbiologist from the manufacturer. as a result of this strategy, resolution to questions the inspector may have regarding data or strategy would come more quickly because the fda hub and the subject matter expert would be speaking the same language. the fda and the manufacturer's subject matter experts could discuss disagreements or fda observations. this would save the time it would take for an inspector, who may have a background in a different area, to understand the strategy employed by the manufacturer's microbiologist and determine if that strategy is appropriate under the cgmps. 143 fda inspection, supra note 125. 144 id. 145 id. 146 id. 785 indiana health law review in order to maintain the approval to manufacture, manufacturers should be required to gain approval from each hub at a predetermined frequency. in order to maintain a license to manufacture approved products, the manufacturer would have the responsibility of showing that each hub has approved the strategies employed by the manufacturer. a proposal for the hub groups: quality control laboratories, validation, engineering, manufacturing/technology, batch disposition, materials management, operations, facilities, and environmental monitoring and sterility assurance. each hub would be responsible for developing expert inspectors in specific subject areas. the quality control laboratories hub would review method transfer protocols, data and transfer reports, method validations, method history, stability data, release data, out of specification results, consistency of data between batches, and lab equipment. the validation hub would be responsible for reviewing cleaning validations, sterilization strategies, media fills, and cross contamination controls. the engineering hub would be responsible for calibrations and preventative maintenance, facility drawings, and the fit and finish of the facility. the manufacturing and technology hub would be responsible for reviewing process validations, changes to the areas, and risk assessments. the batch disposition hub would review the strategies each company employs for final release. the materials management hub would review the quality strategies for incoming material as well as labeling and packaging of outgoing materials. the operations hub would review the standard operating procedures for manufacturing as well as review any deviations from those procedures. the facilities hub would review the design, validation, and data around facility systems such as clean steam and high purity water. the environmental monitoring and sterility assurance hub will review qualifications of the environment, data trending, and deviations in environmental results. rather than a one or two week audit that occurs biannually, the fda hubs would provide notice regarding 786 vol. 11:2 2014 new technology and increased globalization their desire to review various strategies, documents, or data at any point in time. this request would be accommodated by scheduling online meetings or requesting specific documents from a collaborative website. additionally, the fda could schedule an online meeting if a question arises regarding the information they may have been initially provided following a request. on many occasions, this process is how a normal inspection occurs in practice. an inspector will ask for documents or data at the end of the day. the inspector will review the requests that evening and ask follow-up questions the next day. all of the review is done remotely, outside of the presence of the manufacturer. this strategy will require the manufacturer to take responsibility for gaining approval rather than the fda showing up at the manufacturer's door for inspections. the fda hubs would allow one set of inspectors to evaluate strategies from many companies both domestic and foreign. this strategy would allow more consistent guidance in particular areas as well as become an effective means to disseminate the latest strategies being used by the manufacturing industry. an inspector may review the sterility assurance control strategies from a manufacturer in kansas during the morning and then the strategies of a manufacturer from shanghai during the afternoon. based on strategies seen in kansas, the inspector may have some meaningful feedback for the shanghai manufacturer in regards to areas where their strategies may no longer meet the "current" requirements of cgmps. d. onsite inspection strategy the fda should use the tradition inspection model for facility and area tours. employing this strategy would cut down on the time needed to conduct an inspection. it would also allow for more impromptu checks. an inspector would likely be able to complete an onsite inspection in several days rather than a week or two. additionally, on-site inspectors could be in communication with the fda hub inspectors to be given guidance regarding specific areas or 787 indiana health law review actions that should be observed based on perceived weakness in the manufacturers overall strategies. another option available if the fda were to separate inspections into two parts would be the use of private, third party inspectors for facility inspections. this strategy is not unprecedented. the food industries already rely heavily on third party inspections. 147 however, third party inspectors have never been utilized to inspect high risk drug manufacturers. given the criticality of the process and the complex regulations, the fda has retained the responsibility of inspecting high risk facilities. however, congress has indicated it supports the use of third party inspectors. the 2002 medical device user fee and modernization act required the fda to accredit third party inspectors for class ii and class iii devices. 148 additionally, the 2011 food safety modernization act establishes a system of third party certification for imported foods. 149 albeit, both of these examples are for instances that are considered low risk. the fda may feel more comfortable supporting third party inspections of high risk manufacturers if the agency retains a portion of the inspection process itself, which it would with the fda hubs. with hubs, the fda would still directly inspect the strategies, processes, and data of high risk manufacturers. the third parties would be verifying the conditions of the facility which is a much more objective measurement. the manufacturing industry, rather than the fda, would be responsible for funding the third party inspections. the fda should establish an expectation of frequency for onsite inspections. in addition to approval from each fda hub, the manufacturer should be required to pay for a third party inspection of their facility at the frequency established by the fda. the onsite inspection 147 the value of third party audits, aib international, https://www.aibonline.org/press/valueofl'hirdpartyaudits.html (last updated sept. 9, 2009). 148 hultr, supra note 132, at 1244. 149 background on the fda food safety modernization act (fsma), fda, http://www.fda.gov/newsevents/publichealthfocus/ ucm239907.htm (last updated mar. 18, 2013). vol. 11:2788 2014 new technology and increased globalization will be an additional responsibility of the manufacturers in order to maintain the approval to manufacture. the fda was given authority to certify third party manufacturers in the 2011 food modernization act.150 the fda should request similar authorization from congress to certify inspectors of high risk products as well. iv. conclusion given the challenges facing the fda's inspection process, the agency should consider revamping their routine inspection process to become more efficient, nimble, and consistent. this can be accomplished by separating facility inspections into two parts, onsite and online, and segregating inspectors into specialized hubs that concentrate on inspecting specific areas. would this particular strategy avoid the baxter heparin incident? no one can say, but there are two reasons to think it might have. first, it may have increased the availability of fda resources to inspect the chinese plant manufacturing the tainted ingredient. inspections could have occurred by a group of inspectors sitting in washington d.c. secondly, it may have resulted in a dissemination of better methods for testing for adulterants. the method used by baxter was not sensitive enough to recognize the adulterated ingredient and was expensive. 15 ' if the fda had been functioning as a hub, perhaps that particular hub would have been aware of the need for a better methodology. regardless, limited resources and an expanding jurisdiction demand new and creative ideas for inspections. separation of the inspection process is a step in that direction. 150 hut', supra note 132, at 1244. 151 kathy jones, improved test for adulterated heparin, medindia (sept. 23, 2011, 6:47 pm), http://www.medindia.net/news/improved-test-foradulterated-heparin-909951.htm. 789 unfair and harsh results of contributory negligence lives in indiana: the indiana medical malpractice system and the indiana comparative fault act bruce d. jones* table of contents i. introduction ............................................................................... 108 ii. the indiana medical malpractice act .................................. 109 a. the legislative history of the indiana medical malpractice act ............................................................................................ 109 b. major provisions of the medical malpractice act ................... 111 iii. the doctrines of contributory negligence and comparative fault: two defenses to a medical malpractice claim ..................................................................... 117 a. contributory negligence .......................................................... 117 b. comparative fault ................................................................... 119 c. comparative fault in indiana .................................................. 122 1. legislative history of the comparative fault act ............. 122 2. a huge comparative fault exception ............................... 123 n. the state of health care in the united states: examination of medical malpractice legislation in other stable states .............................................................................. 125 v. indiana should abolish the doctrine of contributory negligence in medical malpractice cases ........................... l30 a. the effectiveness of the indiana medical malpractice act.. .... 130 b. contributory negligence is unfair, harsh, and ineffective ..... 131 c. comparing indiana to other states enjoying a stable health care environment .................................................................... 132 d. the effect of adopting the doctrine of comparative fault in the modified form on health care in indiana .............................. 133 e. how does the law get changed? ........................................... 134 vi. conclusion .................................................................................. 135 * j.d. candidate 2009, indiana university school of lawindianapolis; b.a. 2005 washington university in st. louis. i would like to thank my family (tammy, matt, and claire) for all their understanding and sacrifice the last three years while i attended law school and completed this note. i would also like to thank my mom and dad for always pushing me to achieve my goals and never allowing me to settle for second best. 108 indiana health law review [vol. 6:107 i. introduction in 1975, indiana passed the medical malpractice act in response to the growing health care crisis the state was facing.1 in doing so, indiana became the first state to legislatively deal with the crisis by passing statutory reform measures.2 as a result, the indiana statute became a model for other states to follow in order to deal with their own health care crises.3 although indiana was on the forefront of medical malpractice reform, it lagged behind in abolishing the doctrine of contributory negligence as a defense under its tort laws. it was not until1983 that indiana followed the majority of other states in abolishing the doctrine of contributory negligence and replaced it with the doctrine of comparative fault by passing the comparative fault act.4 the comparative fault act, however, specifically exempted medical malpractice claims, leaving the doctrine of contributory negligence in play as a defense against medical malpractice claims.5 by leaving contributory negligence defense available to health care professionals, the plaintiffs in a medical malpractice case could still face the harsh results inherent in the doctrine, 6 including a complete bar to re­ covery.' this result is inequitable and may be. contradictory to the indiana constitution which guarantees every citizen a remedy for injuries caused by another individual. 8 a more equitable approach to apply in medical malprac­ tice cases is a modified comparative fault system. under a modified compara­ tive fault scheme, a patient would be allowed to recover if he was not more at fault than the physician for causing the resulting injury.9 this note will first look at the indiana medical malpractice act, includ­ ing the legislative history and findings that prompted the state legislature to pass the medical malpractice act. part i will also explore the major provisions of the medical malpractice act which work to curb a resurgence of a health care crisis, including five provisions that are essential to protecting the health care environment and ensuring that adequate health care is available for all hoosiers. part ii and m of this note will provide an overview of the doctrines of l. h.r 1460, 99th gen. assemb., reg. sess. (ind. 1975). 2. eleanor d. kinney & william p. gronfein, indiana's malpractice system: no-fault by accident? 54 law & contemp. probs. 169, 169 (winter 1991). 3. jd 4. 1975 ind. acts 1759. 5. ind. code § 34-51-2-l (2006). 6. see cavens v. zaberdac, 849 n.e.2d 526, 529 (ind. 2006) ("under indiana law, the historic common law defense of contributory negligence remains available to defendants in cas­ es alleging medical malpractice."). 7. id at n. 2. (''thus the common law defense of contributory negligence, if proven, bars a patient from recovering any damages for injuries or losses that may have resulted from a phy­ sician's medical negligence."). 8. ind. const. art. 1 § 12 ("all courts shall be open; and every person, for injury done to him in his person, property, or reputation, shall have remedy by due course oflaw.''). 9. see infra note 114. ,· 2009] contributory negugence lives in indiana 109 contributory negligence and comparative fault. 10 in examining the doctrine of contributory negligence, part ii will examine how the doctrine works to serve a defendant in a negligence action, the criticisms of the doctrine, and why a ma­ jority of jurisdictions have abandoned it. in examining the doctrine of compar­ ative fault, part m will discuss how comparative fault has replaced contributory negligence as a defense to negligence in most states, review the various forms of comparative fault which are used, as well as analyze how each applies to a negligence case. finally, part m will look at the comparative fault system in the state oflndiana by discussing the legislative history of the indiana compar­ ative fault act and the exceptions that are specifically provided under the sta­ tute. further, part m will evaluate how these exceptions provide a great advantage to defendant-physicians and place another barrier to recovery in front of medical malpractice plaintiffs. part n of this note will analyze other states which have passed compre­ hensive medical malpractice legislation but use comparative fault in medical malpractice cases to demonstrate that the passage of comparative fault will not lead to another health care crisis in indiana. part n will discuss the legislation in seven states that currently enjoy a stable health care environment. this part will detail the major provisions of each state's legislative acts that serve to pre­ vent a potential health care crisis. many of these provisions are similar or iden­ tical to those found iil the indiana statute. part n will also illustrate that the other seven states all apply the doctrine of comparative fault in cases based on a theory of medical malpractice. in part v, this note will discuss how indiana's contributory negligence system is unfair to plaintiffs injured by physician misconduct. the contributory negligence system is not serving to avoid another "health care crisis," but is instead placing another barrier in the plaintiff's path for receiving just compen­ sation for his injuries. part v will compare the indiana method with that of the seven other states that enjoy a stable health care environment. it will also dem­ onstrate that the provisions of the medical malpractice act provide enough pro­ tections to prevent a recurrence of the health care crisis. in conclusion, this note will discuss some ways in which indiana's law could be changed. ii. the indiana medical malpracrice act a. the legislative history of the indiana medical malpractice act in the mid-1970s, the indiana general assembly ("assembly'') conducted an extensive investigation into the causes of the health care crisis. as a result of the investigation, the assembly passed the medical malpractice act.11 such 10. many jurisdictions may term this doctrine "comparative negligence." this note, however, will refer to it as "comparative fiwlt" since that is the term used to label the indiana statute. 11. h.r. 1460, 99th gen. assemb., reg. sess. (ind. 1975). 110 indiana health law review [vol. 6:107 an act was needed due to a steep increase in the number of malpractice claims and lawsuits, 12 an unreasonable increase in the size of judgments and settle­ ments, 13 and the effects of the increasing judgments and settlements on the en­ tire health care system that were being felt by both patients and health care professionals throughout the state.14 the assembly noted that the major effect of the health care crisis was due to the increasing cost of health care in the state-primarily the costs associated with physicians practicing defensive medicine to protect themselves from liabil­ ities.15 the increased costs of defensive medicine were then being passed to the patients, 16 resulting in patients having to pay more out of pocket costs and high­ er insurance premiums to receive needed medical care.17 the assembly also took note of the drastic effects of obtaining liability insurance for the health care providers due to the increasing number of claims and judgments. 18 the effects were felt by medical and hospital services in the state, 19 but the most drastic effects were felt by the physicians themselves. many liability insurance companies withdrew coverage or refused to cover physicians practicing in high­ risk medical fields. 20 as a result, many services were discontinued and became unavailable to hoosiers.21 in fact, the assembly noted that the rising cost of liability insurance was forcing health care providers to curtail all or part of their 12. h.r. 1460 § 1(a), 99th gen. assemb., reg. sess. (ind. 1975)("thenumberofsuits and claims for damages arising from professional patient care has increase[ d] tremendously in the past several years ... "). 13. id ("[t]he size of judgments and settlements in connection (suits arising from profes­ sional patient care) have increase unreasonable.j. 14. id. at§ 1(b) (''the effect of[the increasing] judgments and settlements, base frequent­ ly on legal precedents, have caused the insurance coverage to uniformly and substantially in­ crease the cost of such insurance coverage.''). 15. id. at§ 1(e). the rising number of suits and claims is forcing health care providers to practice defensively, viewing each patient as a poten~ adversary in a law­ suit, to the detriment of both the health care provider and the patient. health care provide[r]s for their own protection, are often required to em­ ploy excessive diagnostic procedures for their patients, unnecessarily in­ creasing the cost of patient care. 16. id at§ i( c). 17. id 18. h.r. 1460 § 1(d), 99th gen. assemb., reg. sess. (ind 1975) 19. id. at § 1(h) (''the inability to obtain or the high cost of obtaining insurance affects the medical and hospital services available in the state of indiana to the detriment of its citi­ zens.''). 20. id at§ 1(d). the increased costs of providing health care services, the increased inci­ dents of claims and suits against health care providers and the unusual size of such claims and judgments, frequently out of proportion to the actual damages sustained, has caused many liability insurance companies to with­ draw from the insuring of high risk health care providers. 21. id at § 1 (f) ("another effect of the increase of suits and claims and the cost thereof is that some health care providers decline to provide certain health care services which in them­ selves entail some risk of patient injmy. j. 2009] contributory negligence lives in indiana 111 practice.22 the assembly also noted a bigger problem with a longer lasting effect: the increased risk of practicing medicine was discouraging young individuals from gursuing a career in the medical profession, especially in high-risk fields. 3 as a result, the cumulative effect of the assembly's findings was de­ terring both citizens and professionals living and working in indiana. 24 there­ fore, in order to deal with the effects of the health care crisis, the assembly passed the medical malpractice act ("mma") for the purpose of curbing the effects and stopping the health care crisis facing indiana. 25 b. major provisions of the medical malpractice act participation as a qualified or eligible provider under the mma is volun­ tary. 26 therefore, the mma does not bind physicians who choose not to partic­ ipate. a physician who chooses not to become qualified, however, is not able to seek the mma' s protections in the event a suit arises.27 thus, this provision indirectly blocks a potential health care crisis by defining qualified physicians who are eligible to seek the protections of the mma, thereby lowering their malpractice insurance premiums while simultaneously providing a source of funding the state can use to payout claims brought against a qualified physician. the mma has five major provisions which propose to curb the effects of the health care crisis. the first major provision defines providers who are eli­ gible under the mma,28 by setting out the requirements that must be met in order to qualify for protection under its provisions.29 to qualify, the provider 22. /d. at§ 1 (i) ("some healthcare providers have been forced to curtail the practice of all or a part oftheir profession because of the non-availability or high cost ofliability insurance.''). 23. /d. at § 1 (g) ("the cost and difficulty in obtaining insurance for health care providers discourages young physicians from entering into the practice of medicine in the state oflndiana, resulting in the loss of physicians to other states."). 24. h.r. 1460 § 1 (j), 99th gen. assemb., reg. sess. (ind. l975)("the cumulative effect of suits and claims is working both to the detriment of the health care providers and to the citi­ zens of this state."). 25. h.r. 1460 § 2, 99th gen. assemb., reg. sess. (ind. 1975): because of the conditions stated in section 1, it is the purpose ofthis act to establish a system by which a person who has sustained bodily injury or death as a result of tort or breach of contract on the part of a health care providers resulting from professional services rendered, or which should have been rendered, can obtain prompt determination and adjudication of his claim and fair and reasonable compensation at a fair and reasonable cost, from financially responsible health care providers who are able to in­ sure their potential liability at reasonable affordable rates. 26. ind. code§ 34-18-3 (2006). 27. ind. code§ 34-18-3-1 (2006)("a health care provider who fails to qualify under this article is not covered by this article and is subject to liability under the law without regard to this article. if a health care provider does not qualify, the patient's remedy is not affected by this article.") 28. ind. code§ 34-18-3-2 (2006). 29. ld. the statute provides: 112 indiana health law review [vol. 6:107 must pay a surcharge30 that is charged annually by the state.31 the purpose of the income is to provide a source of money that will be used to fund a patient's compensation fund, 32 which provides plaintiff-patients with compensation for the negligence of a physician. 33 the second major provision, and likely the most important in dealing with the health care crisis, is the comprehensive cap that is placed on damages. 34 the mma limits both economic and punitive damages to 1.25 million dollars35 per occurrence. placing a limit on recoverable damages is the best and most direct way to curb high insurance cost pressures on medical professionals. 36 a cap provides a great benefit to providers by keeping insurance premiums for malpractice liability coverage to a minimum. 37 by capping damages, insurance companies know the highest judgment or settlement they will be required to pay should a malpractice suit arise. with this provision, the mma deals directly with the problem of the "long tail''38 of liability that faces insurance carriers. the "long tail" in a policy is usually found under "occurrence based" medical liability insurance policies.39 under this type of policy, the ''tail" of coverage insures the provider for all future claims that arise out of acts or omis­ sions that occur during the period of actual coverage.40 the "long tail" creates a great deal of uncertainty about how much coverage would be needed and the exact period of time the policy needs to cover a physician. under the mma, the uncertainty of the amount of coverage needed to cover the "long tail" is no longer a factor.41 the damage cap sets the ceiling on the amount ofliability for for a health care provider to be qualified under this article, the health care provider or the health care provider's insurance carrier shall: ( 1) cause to be filed with the commissioner proof of financial responsibility established under ic 34-18-4; and (2) pay the surcharge assessed on all health care providers under ic 34-185. 30. ind. code§ 34-18-3-2(2) {2006). 31. ind. code§ 34-18-3-5 (2006). 32. ind. code§ 34-18-3-2(2) {2006). 33. see infra pp. 16, 19-20. 34. ind. code § 34-18-14-3 {2006). 35. /d .. since the act was first past in 1975, the indiana general assembly has modified this section numerous times to keep pace with the changing economical culture. id? claims filed before january 1, 1990 had a damage cap of$500,000. id claims filed on january 1, 1990tojuly 1, 1999 were cappedat$750,000. /d. claims filed after july 1, 1999 are capped at $1.25 million. /d. there has been no adjustment since 1999 and $1.25 million is the current damage cap for the state. /d. the fact that there has not been an adjustment has served as a point of contention and the general assembly draws much criticism for not moving quicker to adjust the damage cap limit in the 21st century. ind. code § 34-18-14-3(2006). 36. steven e. pegalis, 2 am. law. med. mal. § 9:3 (july 2007). 37. /d. 38. in re lavigne, 114 f.3d. 379, 382 (2d cir. 1997) (''tail coverage is insurance cover­ age that becomes effective upon the cancellation or termination of a policy.") 39. lehigh valley health network v. executive risk indemn., inc. 2001 wl 21505 (e. d. pa. 2001). 40. ballow v. phico inc. co. 841 p.2d 344,348 (colo. app., 1992), rev'd on other grounds 875 p.2d 1354 (colo. 1993). 41. see generally pegalis, supra note 36, at § 9.3. 2009] contributory negugence lives in indiana 113 which the insurance carrier will be responsible. thus, the insurance companies can tailor a plan, knowing the exact amount of liability for which it may be re­ sponsible, and thereby save the provider the expense of extra premium pay­ ments to adjust for the unknown.42 the damage limitations provision of the mma also limits the financial amount that a defendant-physician, through his carrier, will be liable to pay in each case up to $250,000.43 this provision ben­ efits both the insurance carriers and the providers by giving a firm amount of liability the doctor must pay out-of-pocket.44 any remaining award is paid by the patient's compensation fund.45 this is also a valuable feature of the mma that serves to keep insurance premiums at an affordable rate.46 finally, mma limits damages by allowing only one recovery for each distinct act of medical malpractice that results in harm.47 if there are multiple instances of malpractice during one surgical procedure, the plaintiff may recover for each act of mal­ practice and each recovery is subjected to the statutory damages cap.48 the next major provision of the mma is the creation of a medical re­ view panel ("panel").49 the purpose of the panel is to review proposed medi­ cal malpractice claims filed against qualified physicians who are eligible under the mma provisions. 50 either party can convene the panel twenty days after a complaint is filed. 51 the panel itself consists of four members:52 an attorney who serves as the panel chairperson and is a resource to the other members for interpretation of the law but has no voting power,53 and three members who must be physicians practicing in indiana. 54 all health care providers who prac­ tice in indiana, with the exception of physicians functioning solely as health facility administrators, are eligible to serve as panel members. 55 the eligible· pool of providers consists of all licensed providers regardless of the area of medicine they practice in. 56 the only caveat is that two of the physician mem42. see/d. 43. ind. code § 34-18-14-4 (b) (2006) ("a health care provider qualified under this ar­ ticle (or ic 27-12 before its repeal) is not liable for an amount in excess of two hundred fifty thousand dollars ($250,000) for an occurrence of malpractice.''). 44. see pegalis, supra note 36, at § 9.3 .. 45. see infra pp. 14-16. this section will explain how the patient compensation fund is utilized when damages are awarded or a settlement is reached where are the amount recoverable is greater than $250,000. 46. see generally pegalis, supra note 35, at§ 9.3. 47. see patel v. barker, 742 n.e.2d 28 (ind app. 2001 ). 48. id. 49. ind. code § 34-18-10-1 (2006). 50. id. 51. ind. code§ 34-18-10-2 (2006) ("not earlier than twenty(20) days after the filing of a proposed complaint, either party may request the formation of a medical review panel by serving a request by registered or certified mail upon all parties and the commissioner."). 52. ind. code§ 34-18-10-3(a)(2006). 53. ind. code§ 34-18-10-3(b)(2006). "theattorneymemberofthemedicalreviewpanel shall act as chairman of the panel and in an advisory capacity but may not vote." 54. ind. code.§ 34-18-10-3(a) (2006). 55. ind. code§ 34-18-10-5 (2006). 56. id. (even licensed providers that practice the profession in an academic setting are 114 indiana health law review [vol. 6:107 bers must practice in the same field as the defendant. 57 for example, if the phy­ sician practices in a highly specialized field such as cardiology, two of the el members must also practice cardiology. 58 the requirement that two members of the panel practice in the defendant's specialty only applies when there is ly one defendant. 59 if there is more than one defendant, then the physician­ members of the panel can be selected without the specialization requirement.60 once selected, the parties submit written evidence to the panel as required by the mma before any court proceeding can commence against a qualified provider. 61 the panel reviews the submissions and then renders an expert opi­ nion. 62 the mma gives the panel the authority to render four different opi­ nions. 63 the benefit of the panel is that it allows both parties to gauge the eligible to serve as panel members.). 57. ind. code§ 34-is-10-8 (2006). 58. id. 59. /d. the statute provides: if there is only one (i) party defendant who is an individual, two (2) of the panelists selected must be members of the profession identified in ic 3418-2-14(1) of which the defendant is a member. if the individual defendant is a health care professional who specializes in a limited area, two (2) of the panelists selected must be health care professionals who specialize in the same area as the defendant. 60. james r. fisher and debra h. miller, 23 ind. prac. §ii: i3 personal injury law & practice (2008): this requirement does not hold true in multiple defendant cases. in that event, there are no requirements as to what specialties must be represented on the panel. often the parties agree as to what specialties should be on the panel. if a party fails to make its selection within the specified time period, the chairman makes the selection. 61. ind. code § 34-is-8-4 (2006): notwithstanding section 1 of this chapter, and except as provided in sec­ tions 5 and 6 of this chapter, an action against a health care provider may not be commenced in a court in indiana before: (i) the claimant's proposed complaint has been presented to a medical review panel established under ic 34-is-10 (or ic 27-i2-l0 before its repeal); and (2) an opinion is given by the panel. 62. ind. code§ 34-is-i 0-22(a) (2006). (''the panel has the sole duty to express the pan­ el's expert opinion as to whether or not the evidence supports the conclusion that the defendant or defendants acted or failed to act within the appropriate standards of care as charged in the complaint''). 63. ind. code§ 34-i8-10-22(b)(2006): after reviewing au evidence and after any examination of the panel by counsel representing either party, the panel shall. within thirty (30) days, give one (i) or more of the following expert opinions, which must be in writing and signed by the panelists: (1) the evidence supports the conclu­ sion that the defendant or defendants failed to comply with the appropriate standard of care as charged in the complaint (2) the evidence does not support the conclusion that the defendant or defendants failed to meet the applicable standard of care as charged in the complaint. (3) there is a ma­ terial issue of fact, not requiring expert opinion, bearing on liability for consideration by the court or jury. (4) the conduct complained of was or was not a factor of the resultant damages. if so, whether the plaintiff suf2009] contributory negugence lives jn indiana 115 strength or weakness of their case before incurring the high cost of going to trial. the panel's opinion may also encourage the parties to settle the case ra­ ther than endure a full trial. finally, the panel's expert opinion "is admissible as evidence in any action subsequently brought by the claimant in a court of law.'.m the fourth major provision of the mma is the creation of a state run pa­ tient compensation fund ("pcfj. 65 the pcf is administered by the indiana department of insurance ("idof')66 and overseen by the insurance commis­ sioner who has a great deal of authority to protect the fund. 67 the pfc is used to pay out large medical malpractice claims levied against an eligible provid­ er.68 the monies used for the fund are collected from the proceeds of the eligi­ ble physician's annual surcharge. 69 after the surcharges are collected from the providers who opt to participate in the mma, the money is turned over to the pcf and the commissioner has wide latitude on how to secure additional funds. 70 the pfc takes effect when a claim exceeds $250,000.71 the health care professional's primary insurer is required to pay up to $250,000 either by judgment of more than $250,000 or by agreeing to settle for $250,000 and then the court orders a remedy in excess of that amount 72 another major provision of this section prevents a physician from refusing to settle.73 after a settlement or judgment is reached, the defendant hospital or physician is removed from the fered: (a) any disability and the extent and duration of the disability; and (b) any permanent impairment and the percentage of the impainnent. 64. ind. code§ 34-18-10-23 (2006). 65. ind. code§ 34-18-6-1 (2006). 66. kinney, supra note 2. 67. ind. code§ 34-18-6-2 (2006): (a) the commissioner, using money :from the fund, as considered necessary, appropriate, or desirable, may purchase or retain the services of persons, firms, and corporations to aid in protecting the fund against claims. the commissioner shall retain the services of counsel described in subsection (b) to represent the department when a trial court determination will bene­ cessary to resolve a claim against the patient's compensation fund. (b) when retaining legal services under subsection (a), the commissioner shall retain competent and experienced legal counsel licensed to practice law in indiana to assist in litigation or other matters pertaining to the fund.( c) the commissioner has sole authority for the following: (1) making a decision regarding the settlement of a claim against the patient compensation fund. (2) determining the reasonableness of any fee submitted to the department of insurance by an attorney who defends the patient compensation fund un­ der this section. (d) all expenses of collecting, protecting, and administer­ ing the fund shall be paid :from the fund 68. ind. code§ 34-18-6-6 (2006). see also kinney, supra note 2, at 174. 69. ind. code § 34-18-6-1 (c) (2006). 70. ind. code § 34-18-6-1 (b) (2006). ("the fund and any income for the fund shall be held in trust, deposited in a segregated account, invested and reinvested by the commissioner as authorized by ic 27-1-13 and does not become part of the state general fund.") 71. kinney, supra note 2, at 174. 72. jd. 73. ind. code§ 34-18-6-6(a) (2006). 116 indiana health law review [vol. 6:107 process and the pcf comes into play. once the pcf becomes involved, the provider's liability is admitted.74 after liability is admitted and the physician's annual aggregate has been depleted, the physician may not object or refuse to settle the claim.75 thus, this provision of the mma positions the state as the insurer for a large portion of a medical malpractice claim if the judgment grants the maximum recovery to the claimant. the final major provision of the mma is the shortened statute of limita­ tions period. 76 in indiana, a claim against a health care provider must be filed within two years of the mma act resulting in the injury.77 the statute was in­ tended to be an occurrence-based statute. 78 the indiana supreme court, how­ ever, has recently held that the law cannot preclude recovery from an individual whose disease or injury does not manifest itself within the statutorily required period of time. 79 thus, while the court recognizes the statute as occurrence­ based, it has cut out a "discovery rule" niche for specific cases that could im­ pose liability on health care professionals years after the alleged malpractice takes place. 80 the mma also features a tolling of the statute oflimitations. the statute of limitations is tolled at the time a complaint is filed with idol. 81 the tolling effect includes any periods of time that the case is being considered by the pan­ el to ninety days after the panel has rendered its decision.82 thus, this provi­ sion prevents a defendant-physician from requesting the convening of a medical review board and using the mma to insure the statute oflimitations runs, and then claiming the statute of limitations defense in any subsequent judicial proceeding. a plaintiff must file their claim with idol to toll the sta­ tute oflimitations. 83 a medical malpractice claim is not considered "filed" un­ til it is "mailed by certified mail to the commissioner of the department of 7 4. kinney, supra note 2, at 175. 75. ind. code§ 34-18-6-6(a) (2006). 76. ind. code§ 34-18-7-1 (2006). 77. ind. code§ 34-18-7-1(b) (2006). a claim, whether in contract or tort, may not be brought against a health care provider based upon professional services or health care that was pro­ vided or that should have been provided unless the claim is filed within two (2) years after the date of the alleged act, omission, or neglect, except that a minor less than six ( 6) years of age has until the minor's eighth birthday to file. 78. havens v. ritchy, 582 n.e.23 792 (ind. 1991) (holding that the statue is an occur­ rence-based statute and "begins to run on the date of the alleged malpractice"). 79. martin v. richey, 711 n.e.2d 1273 (ind. 1999) (''the statue is unconstitutional as applied to plaintiffs who would be precluded from pursuing a claim because the disease or con­ dition would not manifest significant pain or symptoms until several years after the asserted malpractice.") 80. !d. 81. ind. code§ 34-18-7-3 (2006). 82. ind. code§ 34-18-7-3 (2006). 83. comer v. gohil, 664 n.e.2d 389 (ind. ct. app. 1996). 2009] contributory negugence lives in indiana 117 insurance."84 if the plaintiff mistakenly files in court and not with idol, the statute oflimitations is not tolled.85 conversely, if the plaintiff files with idol and the health care provider is not qualified under the mma, the plaintiff is notified and the running of the statute of limitations resumes. 86 iii. the doctrines of contributory negligence and comparative fault: two defenses to a medical malpractice claim a. contributory negligence the defense of contributory negligence in a negligence action was first recognized in england in 180987 and is defined as actions on the part of the in­ jured party which fall below the standard88 of what a reasonable person would do to protect himself.89 in the legal context, the plaintiff's actions combine with the defendant's negligence to cause the actual harm.90 the doctrine of contributory negligence is founded under common law principles. under the doctrine, an injured person whose own negligence results in harm to himself is not allowed to recover for the negligence of anothe?1 if the injury would not have occurred had the injured party followed the standard of care he owed him­ self.92 the effect of the doctrine is to bar any recovery for a person's failure to exercise "ordinary care" for his own well being which is found to be the ''prox­ imate cause" of the harm.93 built into the rule is an "all or nothing" recovery system.94 no matter how slight the plaintiff's actions were in causing harm, a negligent plaintiff cannot recover any damages from a negligent defendant.95 if the defense of contributory negligence is asserted, the plaintiff's contri84. /d. (emphasis added). 85. /d. 86. lusk v. swanson, 753 n.e.2d 748, 751-752 (ind. ct. app. 2001) (holding that if a defendant-physician is not a qualified health care provider under the mma. the statute oflimita­ tions is tolled from the point that idol received the complaint and begins to run again once the plaintiff is notified of the defendants disqualification.) 87. steven gardner, contributory negligence, comparative negligence and stare decisis in north carolina. 18 campbell l. rev. 1, 5 (1996). for a comprehensive look at the early history of the contributory negligence doctrine in england and the untied states see id. at 5-9. 88. restatement(second)oftorts § 464 (1963) (setting outthestandardofconducta person should follow for his own protection). 89. restatement(second)oftorts § 263 (1963). see also 57 bam.jur. 2dnegli­ gence § 797 (2004). 90. /d. 91. 57b am. jur. 2d neglif{ence § 798 (2004) ("the law of contributory negligence is applicable only where both parties are at fault, and when the plaintiff could not by ordinary care have avoided the injury which the defendant's negligence produced."). 92. !d. 93. /d. 94. 57b am. jur. 2d negligence§ 799 (2004). 95. !d. 118 indiana realm law review [vol. 6:107 bution to the injury is determined by conducting a two step analysis.96 first, the trier of fact determines ifboth the plaintiff and the defendant were negligent.97 ifboth parties are found to be negligent, the fact fmder then compares the neg­ ligence of the plaintiff to that of the defendant.98 for a finding of fact on the issue of contributory negligence, the jury must find that the plaintiff satisfies each of the doctrine's three elements. 99 if the fact finder finds any percentage of negligence on the part of the plaintiff, then the plaintiff is barred fromrecov­ ery.•oo the doctrine of contributory negligence has been criticized as an unjust doctrine because it may bar a plaintiff from recovery even if that plaintiff was only slightly negligent.101 forty-six states have found contributory negligence to be inequitable and have abrogated the doctrine in favor of comparative fault. 102 the west virginia supreme court of appeals held that the doctrine's harsh results were against public policy.103 another major criticism of contri­ butory negligence is the negative view the doctrine leaves on the courts that uphold the doctrine. 104 jurors understand the harsh results of the doctrine, which may lead jurors to turn to the practice of"substantialjustice."105 under this practice, the jurors fmd the defendant 100% liable to avoid leaving the plaintiff with an unjust result.106 when this happens, the jurors leave the court­ house with the feeling that the courts do not know how to administer justice.107 finally, the doctrine is criticized because it is confusing and difficult to admi­ nister.108 contributory negligence has several limitations that confuse jurors and are difficult to apply.109 as a result of these criticisms, forty-six states and many leading scholars have completely abandoned the doctrine.110 the movement away from contnbutorynegligence was also recognized by 96. treib v. kern, 513 n.w.2d 908 (s.d.1994). see also 57bam.jur. 2dnegligence§ 806(2004). 97. 7reib, 513 n. w.2d. at 911. 98. /d. 99. hatton v. chem-haulers, inc., 393 so. 2d 950,954 (ala. 1980)("contributorynegli­ gence requires a finding that the party charged has (1) knowledge of the condition; (2) an ap­ preciation of the danger under the surrounding circumstances. and (3) a failure to exercise reasonable care by placing oneself in the way of danger. j; see also 57b am. jur. 2d negli­ gence§ 956 (2004). 100. 57b am. jur. 2d negligence§ 799. l 0 l. restatement (third) of torts: apportionment ofliability § 3 cmt a (2000) ("[this section of the restatement] abolishes certain ameliorative doctrines that were designed to avoid the harsh effects of contributory negligence as an absolute bar to a plaintiff's recovery. j; see also gardner, supra note 86, at l. l 02. 57b am. jur. 2d negligence § 801 (2004). 103. mills v. quality supplier trucking, inc., 510 s.e.2d 280,282 (w.v. 1998). 104. gardner, supra note 87, at 31. 105. gardner, supra note 87, at 30-32. 106. /d. 107. id 108. /d. at 32. 109. /d. 110. /d. at 36-38 2009] contributory negugence lives in indiana 119 the american law institute ("a.l.i.").m in the restatement (third) of torts, the a.l.i. abolished the common law rule of contributory negligence and re­ placed it with the doctrine of comparative fault. 112 while not mandatory au­ thority, the a.l.i. recognizes the common law purpose behind the doctrine of contributory negligence and asserts that the purpose can be achieved without the doctrines unfair and harsh results. 113 by advocating a movement toward the doctrine of comparative fault, the a.l.i. is using its highly persuasive authority to push the law to a more fair and just system as recognized by forty-six states. b. comparative fault due to the unfaimessu4 imposed on plaintiffs by the doctrine of contribu­ tory negligence, many jurisdictions have adopted the doctrine of comparative fault. lis as a result, only four states and the district of columbia maintain the 111. see generally restatement (third) of torts: apportionment of liability §§ 1-9 (2000). 112. restatement ('i'hpid) of torts: apportionment of liability § 3 cmt. a. (2000) 113. id 114. gardner, supra note 87, at 25: the primary criticism of the contributory negligence doctrine is nearly uni­ versal: the contributory negligence doctrine is inherently unfair. the doc­ trine makes one party bear the entire loss even though the loss is caused by the fault of two or more parties. normally, the one party bearing the entire loss is the "injured plaintiff, least able to bear it, and quite possibly much less at fault than the defendant who goes scot free. 115. /d. at 36-38: in 1910, mississippi became the first state to adopt the comparative negli­ gence doctrine generally when the mississippi legislature enacted a pure comparative negligence statute. between 1910 and 1968, six other states re­ jected the contributory negligence doctrine for some form of the compara­ tive negligence doctrine. beginning in 1969, the united states witnessed state after state reject the contributory negligence doctrine for the compara­ tive negligence doctrine. some of these states rejected the contributory neg­ ligence doctrine for the comparative negligence doctrine by statute. others did so by a decision of the state's supreme court. four states adopted com­ parative negligence in 1969, joined by one state in 1970, and four more states in 1971. the "stampede" had begun. eleven states adopted compara­ tive negligence in 1973, followed by one state in 1974, four states in 1975, one state in 1976, and three states in 1979. by the end of 1985, nine more states had made the switch, bringing the number of states rejecting the con­ tributory negligence doctrine for the comparative negligence doctrine to forty-four. in 1986, the contributory negligence roster included only six states: alabama, maryland, north carolina, south carolina, tennessee, and virginia. the south carolina supreme court rejected contributory negli­ gence for comparative negligence in 1991. the tennessee supreme court followed suit in 1992. today, the contributory negligence doctrine has been rejected by forty-six states. it is codified in federal negligence statutes, followed by the united states supreme court in admiralty suits, and pre120 indiana iiealtii law review [vol. 6:107 banner of the contributory negligence doctrine. 116 the methods of adopting a comparative fault system have varied between jurisdictions. 117 in some jurisdictions, comparative fault has been authorized by statute. 118 other states have adopted the system through judicial opinions.119 the adoption of a comparative fault system removes the negative effects of the "all or nothing" recovery rule imposed by the doctrine of contributory negli­ gence. 120 instead, parties are now held liable for their part in causing the harm, allowing damages to be apportioned based on the percentage of fault assigned to each party. 121 like contributory negligence, comparative fault does not come into play in a case unless the trier of fact has established that both the plaintiff and the defendant were negligent in the resulting harm.122 while there are several types of comparative fault systems in the united states, the following are the most prevalent:123 ''pure or 100%" comparative fault, 124 "modified" comparative fault, 12s and the "slight/gross" comparative negligence rule. 126 under the "pure or 1 00%" comparative fault system, dam­ ages are assessed proportionately based on each party's fault 127 for example, plaintiff sues defendant for negligence. the jury finds that the defendant was negligent and awards plaintiff $100,000 in damages. the jury, however, also finds that the plaintiff was twenty percent at fault for the harm. therefore, the plaintiff's damages are reduced by twenty percent, limiting his recovery to $80,000 in damages. this school of thought is the most plaintiff-friendly ap­ plication of the various comparative fault systems. regardless of the amount of the plaintiff's fault, even if he is more at fault than the defendant, the plaintiff will recover the amount of damages less his percentage of fault. under this system, the plaintiff's case cannot be defeated unless the defendant has proven that he was not negligent. the second method is "modified" comparative fault. 128 under the ''mod­ ified" comparative fault system, there are two schools of thought in applying the doctrine. 129 the first holds that the plaintiff's negligence resulting in the harm must be less than the defendants.130 under this rule, if the plaintiff's fault vails in nearly all of the major civilized countries. see also 57b am. jur. 2d negligence 801(2004); 65 cj.s. negligence 291(2000). 116. 57b am. jur. 20 negligence § 956 (2004) (the four states that stiu use contributory negligence as a defense in negligence cases are alabama, maeyland, north carolina, virginia). 117. id at§ 957-58. 118. id at§ 957. 119. id at§ 958. 120. id at § 955. 121. id. 122. 57b am. jur. 20 negligence § 954 (2004). 123. id. at§ 961. 124. id. 125. id. 126. id at § 698 .. 127. id. at§ 962. 128. 57b am. jur. 20 negligence§ 962 (2004). 129. id 130. id 2009] contributory negligence lives in indiana 121 is an equal or greater force in causing the harm, he is barred from recovery. 131 for example, if a jury finds that a defendant is negligent and awards $100,000 in damages, it will proceed to the next step and analyze the plaintiff's conduct. if the jury finds that the plaintiffs conduct was fifty percent at fault for causing the harm, the plaintiff is barred from recovery because his negligence was not less than that of the defendant. conversely, if the jury finds that the plaintiffs actions were forty-nine percent responsible for causing the harm, he would re­ cover damages minus the proportion of his fault. therefore, the plaintiff would recover $51,000 from the defendant. the second school of thought requires that the plaintiffs negligence re­ sulting in the harm must not be greater than the defendant's negligence.132 un­ der this application of the doctrine, the plaintiff may recover as long as his percentage of fault is not greater than that of the defendant. in a jurisdiction that applies this doctrine, the jury could fmd that the plaintiff and defendant were equally at fault and thus award the plaintiff half the damages received from the defendant. 133 turning back to the above example, under this approach the jury finds that the plaintiff was fifty percent at fault for the harm. in this scenario, the plaintiff would still recover $50,000 from the defendant for his portion of the harm. even though the plaintiff was just as responsible for the harm, he is not barred from recovery. if the jury finds the plaintiff fifty-one percent at fault, this approach would bar any recovery. thus the "modified" comparative fault system works to prevent a plaintiff from recovering for the harm they caused themselves, and at the same time does not bar recovery if a majority of the fault causing the harm rests with the defendant. the final system is the "slight/gross" comparative negligence rule. 134 the "slight/ gross" method of comparative fault is used to "render the rule of contri­ butory negligence inapplicable if the contributory negligence of the plaintiff is small" compared to that of the defendant. 135 there is no absolute basis for de­ termining whether the negligence of the plaintiff was slight or gross. 136 this method is based solely on the objective, or reasonable person, standard of neg­ ligence.137 the application of the "slight/gross" rule entitles a defendant to a judgment in their favor if the defendant can prove that the plaintiff's contribu­ tion was more than slight and the defendant's negligence was not gross when compared to the plaintiffs conduct.138 the down side to this application of comparative fault is that there is no definitive rule on how to compare the neg­ ligence of the two parties. 139 this method relies entirely on a case-by-case re131. id. at§ 965. 132. !d. 133. id. at§ 966. 134. 57b am. jur. 2d negligence§ 968 (2004). 135. id. at § 969. 136. id. at § 970. 137. id. at§ 970. 138. id. at§ 968. 139. id. at§ 971. 122 indiana health law review [vol. 6:107 view of the facts. 140 thus, similar facts that exist between two separate cases can result in vastly different outcomes. c. comparative fault in indiana indiana does not ascribe to the harsh and unjust doctrine of contributory negligence. in fact, indiana would proudly point to the fact that they are a comparative fault state in line with an overwhelming majority of states in the union. this is shown through the indiana comparative fault act ("cf a .. ).141 1. legislative history of the comparative fault act passage of the cf a began in 1973.142 the first attempt to bring indiana into the comparative fault system, however, failed.143 two separate bills were introduced, but neither bill made it out of the house judiciary committee.144 in 1981, legislation, based on the 1977 uniform comparative fault act, was in­ troduced.14s the 1981 bill proposed the introduction of a pure comparative fault system.146 the 1981 bill was strongly opposed by lobbyists, particularly from the insurance industry.147 as a result of the strong and influential lobbing effort, the 1981 bill was defeated in committee.148 in 1983, a new comparative fault bill was introduced to the indiana gen­ eral assembly that proposed a "modified., comparative fault system.149 under this system, defendants to tort claims would no longer benefit from the com­ plete affirmative defense of contributory negligence.1' 0 at the same time, plaintiffs in tort actions would no longer be subjected to the harsh penalty of no recovery for their contributory negligence. instead, under the proposed system, a plaintiff would recover damages ifhis contributory negligence was not greater than that of the defendant.1' 1 if the plaintiff's negligence in causing the harm was greater than the defendants, the plaintiff's recovery would be completely barred.1s2 the 1983 bill was the perfect blend of the contributory negligent 140. 57b am. jur. 2d negligence§ 971 (2004). 141. ind. code§ 34-51-2-1 (2006). 142. edgar w. bayliff, drafting and legislative history of the comparative fauh act. 17 ind. l. rev. 863, 863 {1984). 143. ld. 144. ld. 145. id. 146. ld. 147. id 148. bayliff,supranote 142. 149. id. 150. lawrence p. wilkins, the indiana comparative fault act at first (lingering) glance. 171nd. l. rev. 687, 687 (1984). 151. ld. ("[a) plaintiff whose conduct satisfies the statutory definition of"fault" will be entitled to recover damages reduced in proportion to that fiwlt.''). 152. id: if the plaintiff's fiwlt is assessed at greater than 500.4, ... recovery will be to2009] contributory negugence lives in indiana 123 principle of not rewarding someone for their own negligence while at the same time removing the harshness of a complete bar of recovery. this bill was intro­ duced to both houses where it passed by a large majority vote in each house. 153 the bill was sent to governor robert orr, who ratified the bill on april 21, 1983.154 comparative fault in indiana went into effect on january 1, 1985.155 under this legislation, indiana adopted the comparative fault in its modified form, barring a plaintiff's recovery when he is more at fault than the defen­ dant. 156 while there was a comparative fault act in place, it was not true com­ parative fault across the board. 2. a huge comparative fault exception while the principles of contributory negligence are still present under the cf a, 157 there is still one group158 of plaintiffs which must face the cruelties of the contributory negligence defense. the cf a has two provisions that affect medical malpractice cases. first, the cfa specifically exempts cases of medi­ cal malpractice against qualified health care providers. 159 the indiana supreme court has clarified this by exempting qualified heath care providers from the cf a-the legislature intended the common law defense of contributory neglitally barred. the indiana comparative fault act is ... not a complete accep­ tance of the comparative fault principle because the common law tory negligence bar continues to operate for some injured plaintiffs who are not wholly responsible for their injuries. 153. bayliff; supra note 139, at 865-66. (the original bill, senate bill331, was passed in the senate by a 34-15 vote. senate bill331 was then sent to the house where it was met with a strong resistance and fears that it would cost the state millions of dollars. subsequently, the deadline for the house to approve senate bills passed, and the only way the comparative fault bill would be enacted was to strip a bill that had already passed and add the language of s.b. 331 to it. fortunately for the comparative fault act, kokomo senator james butcher sacrificed his bill, s.b. 287, dealing with the distribution of trust assets, for the comparative fault bill. the language of331 was substituted in 287. the new substituted bill was approved by the senate 41 to 6 and the house 78 to 12.). 154. ld at 866. 155. id 156. ind. code 34-51-2-6 (2006). 157. 57b am. jur. 2d negligence§ 961(2004). 158. the cf a exempts government entities from its provisions. thus, anyp1aintiffbring­ ing a negligence suit against a governmental body within the state must face the contributory negligence defense and bare its force should that be found to have contributed to their injuries. government entities, however, are beyond the scope of this note. see generally ind. code§ 34-51-2-2 (2006). 159. ind. code§ 34-51-2-1 (2006): (a) this chapter governs any action based on fault that is brought to recover damages for injury or death to a person or harm to property, except as pro­ vided in subsection (b). (b) this chapter does not apply to an action: (1) brought against a qualified health care provider under ic 16-9.5 (before its repeal), ic 27-12 (before its repeal), or ic 34-18 for medical malprac­ tice. 124 indiana heal til law review [vol. 6:107 gence to be available to this class of defendants.160 with this doctrine, plaintiff­ patients in a medical malpractice suit may still be barred from recovery if the court finds that they contributed to their own injury, regardless of how slight their apportionment offault may be.161 the reality of this law is that a plaintiff may be barred from complete recovery for simply failing to take a prescribed medication one time as instructed.162 the second aspect of the cf a is that it provides a process to combine cases that involve both qualified and unqualified health care providers. 163 un­ der the mma, claims against a qualified provider are required to go before a panel. when both qualified and unqualified health care professionals commit an act of medical malpractice under the mma it is possible for the unqualified providers' case to go to trial before the panel completes its review of the case against the qualified provider. 164 the cf a addresses and alleviates this prob­ lem.165 it gives the court the authority to "grant reasonable delays" to allow the panel to complete its evaluation of the case against the qualified defen­ dant(s).166 once the panel has completed its evaluation, rendered a decision, and an action can be brought against the qualified defendant, the court must then allow joinder of the qualified defendant before the suit can proceed.167 this section of the cf a bestows two benefits on the plaintiff-patient.168 first, it prevents the plaintiff from enduring two separate trials based on the same fact pattern.169 second, it prevents the defendant-physicians from using the "empty chair'' defense and pointing the finger at a non-party to shift blame.170 while these are huge benefits for the plaintiff, these provisions do not prevent the plaintiff-patient from the prospect of facing the contnbutorynegligence defense 160. gavens, 849 n.e.2d at 529. 161. id. 162. ld.; see also hanis v. cacdac, 512 n.e.2d 1138, 1141 (ind. ct app. 1987). 163. ind. code§ 34-51-2-18 (2006). 164. wilkins, supra note 150, at 739. 165. id. 166. ind. code § 34-51-2-18 (2006). this section applies to an action based on fault that is brought by the clai­ mant against: (1) one (i) or more defendants who are qualified health care providers under ic 34-18; and (2) one (1) or more defendants who are not qualified health care providers. (b) upon application of the claimant, the trial court shall grant reasonable delays in the action brought against those defendants who are not qualified health care providers until the medical re­ view panel procedure can be completed as to the qualified health care pro­ viders." see also wilkins, supra note 150, at 740. 167. ind. code§ 34-51-2-18(c) (2006). ("when an action is permitted to be filed against the qualified health care providers, the trial court shall permit a joinder of the qualified health care providers as additional defendants in the action on file against the nonhealth care provid­ ers."). 168. wilkins, supra note 150, at 740. 169. id. 170. id. 2009] contributory negligence lives in indiana 125 and thus the prospect of being denied recovery altogether. n. the state of heal1h care in the united states: examination of medical malpractice legislation in other stable states with the skyrocketing cost ofhealth care, all states have taken action and adopted tort reform statutes.171 the effectiveness ofthese reforms, however, has varied from state to state.172 according to the american medical associa­ tion ("ama''), eighty-six percent of the states (including the district of colum­ bia) are in or on the borderline of a medical liability crisis. 173 only eight states are currently on stable ground with their health care systems, 174 including indi­ ana.175 arguably, indiana's stable health care environment is due to the com­ prehensive medical tort reform legislation enacted in i 975, as indiana was the first state to pass such a comprehensive health care reform and its legislation served as a model for other states to follow. 176 california has taken steps to keep the cost ofhealth care down and avoid another health care crisis. california allows medical malpractice actions to be brought in court provided that the health care professional is given a ninety day notice of the action.177 there are no unusual notice requirements, and failure to meet the notice requirement does not kill the action.178 in fact, the only effect of failure to comply with notice is possible sanctions against a plaintiff's attor­ ney.179 a second measure taken by the california state legislature was the limi­ tation of non-economic damages in actions against health care providers.180 in medical malpractice actions, the statutory limit on non-economic damages is $250,000.181 a third step taken by california was to impose a statute oflimita­ tions on all medical malpractice claims.182 in california, an injured patient has three years from the date of ~ury or one year after date of discovery, whichev­ er is longer, to file suit.183 finally, california is a comparative fault state, 184 as 171. westlaw 50 state survey. health care: medical malpractice, tort reform. (west 2008) (showing all 50 state and the district of columbia have passed medical malpractice tort reform.). 172. american medical association, ''medical liability crisis map," ama news and information, (januiiiy 2007), available at http://www.wisconsinmedicalsociety.org/ _ wms/ communication/press_release/med_liab_jan07.pdf. 173. /d. (according to the ama, seventeen states are currently facing a health care crisis. twenty-six states are teetering on the edge of a crisis and eight states are stable.) 174. id. (the eight stable states are: california, colorado, idaho, indiana, louisiana, new mexico, texas, and wisconsin.). 175. id. 176. kinney, supra note 2, at 169. 177. cal. clv. proc. code§ 364 (west 2006). 178. cal. clv. proc. code § 365 (west 2006). 179. id. 180. cal. clv. code§ 3333.2 (west 1997). 181. id. 182. cal. civ. proc. code§ 340.5 (west 2006). 183. id. 126 indiana health law review [vol. 6:107 it has adopted the doctrine of comparative fault judicially.185 the system adopted, however, was a pure comparative fault. 186 under this framework, a party can always recover damages in an action for any percentage of injury which were not caused by his own fault. 187 colorado is another state on the ama's stable list. in 1988, the colorado state legislature recognized the importance of continued availability and access to health care for its citizens. 188 the colorado state legislature enacted medical malpractice tort reform by passing the health care availability act e'liability act").189 the "liability act" provides a $300,000 damages cap on punitive damages against a defendant-physician in medical malpractice actions effective july 1, 2003. 19° colorado, however, has not capped damages awarded for eco­ nomic loss. 191 the state implemented procedural requirements to control judg­ ments calling for high economic loss values. 192 when a court enters a judgment for economic loss damages, it must order that the damages be paid out through periodic payments when the damages awarded are greater than $150,000. 193 when the trier of fact awards economic loss damages, it must make specialized separate fmdings for each claim, specifying194 "any past damages"195 and "any future damages and the period oftime over which they will be paid."196 the 184. see li v. yellow cab co. of california, 532 p.2d 1226 (cal. 1975). 185. jd at 1247. 186. /d. at 1242. 187. 57b am. jur. 2d negligence§ 961(2004). 188. colo. rev. stat. ann.§ 13-64-102 (west 2005). 189. /d. at 13-64-101 to -503 (west 2005). 190. /d. at§ 13-64-302 (west 2005). 191. /d. at§ 13-21-102.5 (west 2005). the general assembly finds, determines, and declares that awards in civil actions for noneconomic losses or injuries often unduly burden the eco­ nomic, commercial, and personal welfare of persons in this state; therefore, for the protection of the public peace, health, and welfare, the general as­ sembly enacts this section placing monetary limitations on such damages for noneconomic losses or injuries. 192. /d. at§ 13-64-203 to -204. 193. id at§ 13-64-203. in any civil action for damages in tort brought against a health care profes­ sional or a health care institution, the trial judge shall enter a judgment or­ dering that awards for future damages be paid by periodic payments rather than by a lump-sum payment if the award for future damages exceeds the present value of one hundred fifty thousand dollars, as determined by the court. (2) in any such action in which the award for future damages is one hundred fifty thousand dollars or less, present value, the trial judge may or­ der that awards for future damages be paid by periodic payments. 194. colo. rev. stat. ann. § 13-64-204 (west 2004). 195. /d. at§ 13-21-204(a) (the type of past damages that the jury can award for are "(i) medical and other costs of health care; (ii) other economic loss except loss of earnings; (iii) loss of earnings; and (n) noneconomic loss.") 196. /d. at§ 13-64-204(b) (the types of future damages for which the trier of fact my award for are: (i) medical and other costs ofhealth care; (ii) other economic loss except loss of future earnings which would be incurred for the life of the claimant or any lesser period; (ill) loss of future earnings which would be incurred for the work life expectancy of the claimant or 2009] contribu'iory negijgbnce lives in indiana 127 colorado statute, however, does not require that the case be reviewed by a pan­ el nor does it mandate a shortened statute oflimitations period. 197 finally, col­ orado is a comparative fault state, 198 using a modified comparative fault doctrine which bars recovery only if the plaintiff's negligence is as great as or greater than the negligence of the defendant 199 the colorado comparative fault statute does not carve out an exception for health care professionals. 200 louisiana also enjoys a stable health care environment and has adopted extensive medical malpractice legislation. 201 louisiana requires that all medical malpractice claims be reviewed by a panel, administered as a binding arbitra­ tion procedure, prior to being litigated in a court of law. 202 the composition of the panel is the same as the boards formed in indiana: one attome~03 who serves as the chairperson204 and three medical doctors. 205 the physician­ members sitting on the panel must have unrestricted licenses to practice in the state.206 if the defendant specializes in a particular field of medicine, then two of the physicians on the panel must practice in the same specialized field. 207 the sole duty of the panel is to render an expert opinion based on all the evi­ dence and state whether or not the defendant-physician did or did not meet the appropriate standard of care under the circumstan.ces.208 once the expert opia lesser period; and (iv) noneconomic loss which would be incurred for the life of the claimant or any lesser period.). 197. see generally cow. rev. stat. ann. § 13-64 (west 2004). 198. id at§ 13-21-111. 199. id at§ 13-21-111(1): contributory negligence shall not bar recovery in any action by any person or his legal representative to recover damages for negligence resulting in death or in injury to person or property, if such negligence was not as great as the negligence of the person against whom recovery is sought, but any damages allowed shall be diminished in proportion to the amount of negli­ gence attributable to the person for whose injury, damage, or death recov­ ery is made. 200. id 201. la. rev. stat. ann.§§ 40:1299.41-.49 (2001). 202. la. rev. stat. ann. § 40:1299.47 (2001 & supp. 2007). 203. id. at§ 40:1299.47(c). 204. id. at§ 40:1299.47(c)(2). 205. id at§ 40:1299.47(c). 206. id. at§ 40:1299.47(c)(3)(t). 207. id at§ 40:1299.47(c)(3)(j). 208. la. rev. stat. ann. § 40: 1299.47(0). the panel is required to render one or more of the following three opinions: (1) the evidence supports the conclusion that the defendant or defendants failed to comply with the appropriate standard of care as charged in the complaint. (2) the evidence does not support the conclusion that the defendant or de­ fendants failed to meet the applicable standard of care as charged in the complaint. (3) that there is a material issue of filet, not requiring expert opinion, bearing on liability for consideration by the court. ( 4) when para­ graph (1) of this subsection is answered in the affirmative, that the conduct complained of was or was not a factor of the ~tant damages. if such conduct was a factor, whether the plaintiff suffered: (a) any disability and 128 indiana health law review [vol. 6:107 nion is rendered, it is admissible in court as expert testimony. 209 the louisiana state legislature has also created a pcf to be used to com­ pensate plaintiffs for injuries received in a medical malpractice claim. 21° funds for the pcf are raised by placing a surcharge on all qualified providers practic­ ing in the state.211 the louisiana law, much like the indiana statute, gives the commissioner who oversees the fund wide latitude to use and protect the mo­ nies in the fund. 212 louisiana has also placed a cap of $500,000 on non-economic damag­ es.213 as in the indiana mma, louisiana's law requires the physician to be a qualified provider as determined by financial responsibility for the cap on non­ economic damages to apply.214 louisiana, however, does not place a cap on economic damages. 215 for the jury to determine that the plaintiff qualifies for "future medical expenses and related benefits,'.216 the jury must be given a spe­ cial interrogatory to determine the plaintiff's need for "future medical expenses and related benefits."217 there has been a constitutional challenge to the non­ economic damages provision of the louisiana act. 218 the louisiana court of appeals has held that the damage cap provision of the louisiana act is unconsthe extent and duration of the disability, and (b) any permanent impairment and the percentage of the impairment. 209. /d. at.§ 40:1299.47(h). 210. /d. at§ 40:1299.44 (2001 & supp. 2007). 211. /d. at§ 40:1299.44a(2xa). 212. /d. at§ 40:1299.44a(5xa). 213. la. rev. stat. ann.§ 1299.42(bx1) (2001). 214. /d. at§ 1299.42(0). a health care provider who fails to qualify under this part is not covered by the provisions of this part and is subject to liability under the law without regard to the provisions of this part. if a health care provider does not so qualify, the patient's remedy will not be affected by the terms and provi­ sions of this part, except as hereinafter provided with respect to the suspen­ sion and the running of prescription of actions against a health care provider who has not qualified under this part when a claim has been filed against the health care provider for review under this part. 215. /d. at§ 40:1299.43. 216. id at§ 40:1299.43(b): i) "future medical care and related benefits" for the purpose of this section means all of the following: (a) all reasonable medical, surgical, hospitaliza· tion, physical rehabilitation, and custodial services and includes drugs, prosthetic devices, and other similar materials reasonably necessary in the provision of such services, incurred after the date of the injury up to the date of the settlement, judgment, or arbitration award. (b) all reasonable medical, surgical, hospitalization, physical rehabilitation, and custodial ser­ vices and includes drugs, prosthetic devices, and other similar materials reasonably necessary in the provisions of such services, after the date of the injury that will be incurred after the date of the settlement, judgment, or ar­ bitration award. (2) "future medical care and benefits" as used in this sec­ tion shall not be construed to mean non-essential specialty items or devices of convenience. 217. /d. at§ 40:1299.43(a)(1). 218. see arrington v. er physicians group, 940 so.2d 777 (la. ct. app. 2006). 2009] contributory negligence lnes in indiana 129 titutional.219 the status of the law, however, is still in question as the louisiana supreme court has vacated the louisiana court of appeals decision and re­ manded the case for further findings. 220 like the majority of jurisdictions, louisiana is a comparative fault state221 and has statutorily established a doctrine of''pure" comparative faulfll for the sole purpose of preventing the harsh results indicative of the contributory negli­ gence doctrine.223 by adopting comparative fault in its pure form, louisiana allows damages to be apportioned between both parties of an action when both are negligent in causing the litigated harm. 224 the pure system of comparative fault is much friendlier to the plaintiff than either of the modified forms of the doctrine. under the pure system, a plaintiff's damages can be reduced to com­ pensate for the plaintiff's own negligence.225 this is a major benefit for the plaintiffbecause it ensures that the plaintiff's claim will not be completely de­ feated even if the majority of responsibility for the injury lies with the plaintiff himself. 226 four other states--idaho, new mexico, texas, and wisconsin-are en­ joying a stable health care environment and have followed the same pattern as the four preceding states. all four states have passed medical malpractice legis­ lation. 227 while the individual statutes may differ slightly, there are a few noti­ ceable similarities between these states' methods of dealing with medical malpractice cases. first, all four states have a statute oflimitations addressing when medical malpractice actions may be brought against a provider. 228 second, all the states have special procedural requirements placed on actions for medical malpractice.229 these special procedures include the requirement for a case review by a pane1,230 special expert reports from both parties to be 219. id. 220. see arrington v. galen-med, inc., 947 so.2d 719 (la. 2007). 221. la. rev. stat. ann. art. 2323 (1997). 222. id 223. watson v. state farm fire & cas. ins. co, 469 so.2d 967,971 (la. 1985) ("a pure comparative fault system was adopted in louisiana in 1979 by act no. 431. that act became effective only on august 1, 1980. it was specifically designed to ameliorate the harshness of the contributory negligence doctrine ... j. 224. id. 225. /d. at 971 fu. 9. 226. id ("under the pure compamtive fault system, adopted by the louisiana legislature in 1980, plaintiffs negligence will only diminish, not defeat, recovery as long as plaintiffs negli­ gence is less than 100%. "). 227. see idaho code ann.§§ 6-1001 to-1013 (2006),n.m. stat. ann.§§ 41-5-1 to-29 (west 1996), tex. clv. prac. & rem. code ann. §§ 74.001-507 (vernon 2005), and wis. stat. ann.§§ 655.001-.68 (west 2004). 228. seeidahocodeann. § 5-219(2006), n.m. stat.ann. §41-5-13(west 1996), tex. clv. prac. & rem. code ann. § 74.251(vernon 2005 and supp. 2007.) and wis. stat. ann. 893.55 (west 1997). 229. seeidahocodeann. §§ 6-1001 to-1013(west2006), n.m.stat.ann. §41-5-14 (west 1996), tex.civ.prac.&rem.cooeann. § 74.351(vernon2005),andwis.stat.ann. §§ 655.42-.61 (west 2004). 230. see idaho code ann. §§ 6-1001 (2006) and n.m. stat. 'ann. § 41-5-14 (west 130 indiana healtii law review [vol. 6:107 produced in a specific period oftime,231 and a requirement for mediation.232 third, each state, with the exception ofldaho, places a cap on damages.233 fi­ nally, in addition to the states having passed medical malpmctice legislation, all four states are comparative fault states.234 none ofthe states create an excep­ tion for medical malpractice cases, subjecting plaintiffs injured by health care providers to the harsh results of the contributory negligence doctrine. v. indiana should abolish the doctrine of contributory negligence in medical malpractice cases a. the effectiveness of the indiana medical malpractice act indiana should allow its modified doctrine of compamtive fault to include cases claiming medical malpractice. application of the doctrine of contributory negligence is excessive when used in conjunction with the mma. the mma sets out many limitations and procedural requirements including the shortened statute of limitations that are designed to insulate the medical profession from frivolous lawsuits and large judgments or settlements. 235 the statute oflimita­ tions serves to prevent old, stale lawsuits from being filed against a physician when the facts, records, and witnesses' memories of the case have become clouded by the element of time.236 along with the shortened statute of limitations, the mma requires all medical malpractice claims against qualified providers be submitted to the pan­ el process. 237 the panel then reviews the case and renders an expert opinion. by requiring panel review, the parties get a sense of the strength of their case which works to promote settlement. the only foreseeable complication to this process occurs when there is a complaint filed simultaneously against both a qualified and a non-qualified physician. should this circumstance arise, how­ ever, the cfa effectively deals with it by giving the trial court the power to gmnt "reasonable delays" in order to give the panel time to complete its review against the qualified provider(s).238 finally, the mma places the hard cap on all damages in medical malprac­ tice cases.239 both economic and non-economic damages are capped at $1.25 1996). 231. tex. code ann.§ 74.35l(vernon 2005 and supp. 2007). 232. wis. stat. ann. §§ 655.42 (west 2004). 233. seen.m. stat. ann.§ 41-5-6 (west 1996)(limitingeconomic damages), tex. clv. prac. & rem. code ann. § 74.301 (west 2005) (limiting non-economic damages), and wrs. stat. ann. 893.55 (west 1997) (limiting non-economic damages). 234. see idaho code ann. § 6-802 (west 2005), tex. cn. prac. & rem. code ann. § 33.001-002(west 1997), wis. stat. ann. 895.045 (west 2006), and scott v. rizzo, 634 p.2d 1234 (n.m., 1981). 235. ind. code§ 34-18-7-1 (2006). 236. ind. code§ 34-18-7-1 (2006). 237. ind. code§ 34-18-8-4 (2006). 238. ind. code§ 34-51-2-18 (a)(b)(2006). see also wilkins, supra note 147, at 740. 239. ind. code§ 34-18-14-3 (2006). 2009] contributory negugence lnes in indiana 131 million.240 this provision is in stark contrast to the other stable states discussed in this note. indiana is the only one of the eight states that places a limit on economic damages. thus, in all cases filed against a qualified physician, the maximum possible recovery is already known and worked into the medical malpractice liability insurance agreement. all of these protections combine to insure that the cost of medical malpractice insurance will not cause professional liability insurance to sky rocket. they also insure that health care costs will remain reasonable for all hoosiers. therefore, retaining the doctrine of contri­ butory negligence serves no function in keeping indiana out of a health care crisis. b. contributory negligence is unfair, harsh, and ineffective the indiana state legislature was well aware of the harsh and often unfair results that were at the heart of the doctrine of contributory negligence. this was evident by the fact that seven years after enacting the mma, indiana changed its law to conform to the majority of states by adopting comparative fault. 241 when the mma was originally passed in 1976, indiana had a system in place that recognized contributory negligence in all tort cases based on a theory of negligence. 242 currently, indiana has abolished the doctrine in all but two areas of tort law: suits against government entities and medical malprac­ tice claims. 243 in the area of medical malpractice, the doctrine does not lead to just results. by maintaining the doctrine of contributory negligence, indiana essentially gives a defendant-health care providers the ability to completely es­ cape liability when they are, for all intensive purposes, negligent and deserving of reprimand. the doctrine of contributory negligence also creates a disincen­ tive for settling the case. should a defendant believe that the plaintiff has any fault in the harm, the availability of the contributory negligence defense creates an incentive for the physician to take the matter to trial. the physician also has less of an incentive to end the case quickly with a settlement. he can take a firm attitude and refuse any reasonable settlement terms that the plaintiff may propose. as a result of this "escape clause," both parties may be forced to en­ dure a lengthy trial and waste the courts' resources in a case where the defen­ dant is obviously guilty of medical malpractice. the irony of it all is the fact that the mma was passed to insure that all citizens of indiana would continue to receive quality health care. yet, the state grants a physician an "escape 240. ind. code§ 34-18-14-3 (2006). 241. gardner, supra note 87 (showing that from 1910, when the first state recognized com­ parative fault to 1979, thirty five states and the district of columbia changed their laws, either judicially or statutorily, to recognize the doctrine of comparative fault as a defense in negligence suits.) 242. solonosky v. goodwell, 892 n.e.2d 174, 185 (ind. ct. app. 2008) (stating that the primary purpose of the [indiana comparative fault] act was to modify the common law rule of contributory negligence ... ). 243. ind. code 34-51-2-2 (2006). 132 indiana health law review [vol. 6:107 clause" and bars the patient from recovery when the provider fails to deliver quality health care. the entire process of maintaining contributory negligence in medical malpractice cases is counter-intuitive to the purpose of the mma. there is also no evidence that maintaining a contributory negligence scheme helps to ensure that the costs ofhealth care and medical liability insurance pre­ miums remain low. c. comparing indiana to other states enjoying a stable health care environment the major argument against the adoption of comparative fault in medical malpractice cases is that it will subject providers to more liability and thereby cause indiana to spin into another health care crisis. there is no evidence, however, that applying the doctrine of contributory negligence to medical mal­ practice cases has kept indiana out of a health care crisis. the evidence sug­ gests that whether a state is a contributory negligence state or a comparative fault state has no bearing on the stability of its health care environment.244 as can be seen by comparing the eight stable states side by side, indiana stands alone in applying the doctrine of contributory negligence to medical malprac­ tice cases, while the other states apply a form of comparative fault to such cas­ es. 245 furthermore, it does not appear that the form of comparative fault applied affects the stability of the health care environment. the evidence shows that the defenses available to a defendant-physician are not a component in creating a stable health care environment. the strongest evidence for achieving a stable health care environment is taking some type oflegislative action that directly addresses medical malprac­ tice cases and provides some limitations. arguably, the most effective way to ensure health care stability is by capping damages at a modest level. in fact, of the eight states that have a stable health care environment, idaho is the only state that does not place a cap on any damages.246 four of the remaining eight states cap non-economic or punitive damages but allow the court to award full economic damages. 247 one state caps non-economic damages and places a hy­ brid form of economic damages by allowing the plaintiff to recover for medical and other related expenses.248 the final state places a cap on economic damag­ es. 249 indiana places a cap on both economic and non-economic damages. 250 this makes indiana the most stable system because the maximum award for 244. see supra section iv 31-40. 245. see supra section iv 31-40. 246. see supra section iv 31-40. 247. cal. civ. § 3333.2 (west 1997), colo. rev. stat. ann. § 13-64-302 (west 2005), tex. civ. prac. & rem. code ann. § 74.301 (vernon 2005), and wis. stat. ann. 893.55 (west 2004). 248. la. rev. stat. ann. § 1299.42(bx1) (2001). 249. n.m. stat. ann.§ 41-5-6 (west 1996). 250. ind. code§ 34-18-14-3 (2006). 2009] contributory negijgence lives in indiana 133 damages is already pre-determined. the other states still have uncertainty of how great the damages awarded will truly be when the economic damages are calculated. another similar aspect is the special procedural requirement that the states place on medical malpractice cases. whether it is advanced notice statutes, peer review boards, or requirements mandating mediation, all of the proposed requirements help to promote settlement between the parties. it is commonly believed that a health care provider who receives a negative opinion from a panel would be more likely to settle with the plaintiff rather than face a poten­ tially lengthy trial and publicity inherent with the same. similarly, advanced notice statutes give the defendant advanced warning to allow him to evaluate the case and propose a settlement to the complaining party. the gist of these procedural requirements is to help the parties to avoid the expense oflitigation. by avoiding the litigation, the cost to health care providers and their insurers is decreased and thereby the cost of health care is kept under control for the states' respective citizens. d. the effect of adopting the doctrine of comparative fault in the modified form on health care in indiana if the other stable states are any gauge on the effects of applying compara­ tive fault in medical malpractice cases, adopting comparative fault in indiana will not affect the health care environment in the state. indiana has already adopted a modified comparative fault system for all tort cases except in lawsuits against health care entities and governmental bodies.251 under the indiana sys­ tem, the plaintiff does not recover damages when his fault is apportioned great­ er than fifty percent. 252 this application still provides a substantial obstacle and bars recovery when the plaintiff is more responsible than the provider for the harm, thereby giving the physician a formidable defense tactic. conversely, when a patient is not more at fault than the provider, he can recover from the provider for his allocation of responsibility in causing the injury and is not completely barred from recovery for an injury that results from a physician's negligence.253 this type of result is more fair and upholds the principle of not rewarding a plaintiff who was more responsible for his own injuries than the defendant. thus, adoption of this method would not be against the intent of the legislature when it adopted the mma. rather, the more equitable system of modified comparative fault would be closer to the legislature's intent of insur­ ing quality health care for all hoosiers. finally, with all the layers of protection inherent in the mma, the adop­ tion of comparative fault would not place health care providers in a worse posi251. ind. code 34-51-2-1 (2006). 252. ind. code 34-51-2-6 (2006). 253. ind. code 34-51-2-5 (2006). 134 indiana healm law review [vol. 6:107 tion and subject them to more liability. as discussed previously, indiana has more safeguards built into its mma than the other seven "stable" states. those safeguards, not the doctrine of contributory negligence, are what have created a stable health care environment in fact, according to the ama, the four states254 that still adhere to the doctrine of contributory negligence in their tort law are facing or are on the brink of facing a health care crisis?ss whether or not a state uses comparative fault or contributory negligence as a defense against a medical malpractice action has no bearing on preventing a health care crisis, neither does the use of a particular form of comparative fault therefore, the only functions served by keeping the doctrine of contributory negligence in medical malpractice actions in indiana is to place yet another barrier in front of wronged patients and create a potential windfall for a negligent physician, the­ reby allowing him to escape unscathed for his wrongful conduct. that is not, and cannot ever be, a fair system which works to promote quality healthcare in indiana. e. how does the law get changed? indiana has a statutory provision that carves out an exception for medical malpractice cases from the cf a. the state courts have been very reluctant, and maybe rightfully so, to overrule the state legislature when it comes to the issue of health care. thus, it is unlikely that the courts of indiana will stray from their position oflegislative deference and past jurisprudence, void stare decisis, and adopt the doctrine of comparative fault through case law. it may be possible to challenge the constitutionally of the comparative fault's exceptions. the indiana constitution provides that a citizen is allowed full recovery for injuries they have received from another.2s6 the common law tradition of contributory negligence, however, is well entrenched in the history and tradition of indiana and the law itself. based on this fact, a constitutional challenge is unlikely to succeed. even though a strong constitutional case could be made, a constitutional challenge is not likely to be the most efficient answer to changing the law. the most successful method would be a change in the law itselfbythe cit­ izens of indiana. this could be done by placing an initiative on the ballot or placing pressure on the state legislature to introduce an amendment to the cf a. the cf a was strongly influenced by lobbyists, especially from the medical lia­ bility insurance lobby. 257 their stance against the adoption of comparative fault 254. these four states are: alabama. maryland, north carolina, and virginia. 255. american medical association, "medical liability crisis map," ama news and information, (january 2007), available at hup:/lwww.wisconsinmedicalsociety.org/_ wms /communication/press_ releaselmed _liab jan07 .pdf. 256. ind. const. art. 1 § 12. 257. baylifl: supra note 142, at 863. 2009] contributory negligence lives in indiana 135 stalled two attempts to adopt the doctrine in committee in 1973 and 1981.258 it is likely that this was the same lobby responsible for the cf a, which passed with the health care exception. state legislatures are elected officials and work for the people of the state. therefore, the most effective way to make change to the law is to force the representatives to work for the people and adopt laws that the people choose. the cf a as it stands represents special interest groups and works against the state's citizens. it makes sense that the only people who have the capacity to change the law are the people who the law affects. thus, the people oflndiana, calling for an amendment to abolish the doctrine of contribu­ tory negligence in medical malpractice cases, is the most likely, and possibly the only way, to change the law of the state. vi. conclusion the indiana legislature adopted the medical malpractice act in 1976 to deal with a health care crisis. in 1983, the indiana general assembly moved the state of indiana in line with the majority of jurisdictions by passing the comparative fault act. indiana, however, is out of step with the majority in allowing medical malpractice cases to maintain the doctrine of contributory negligence as a defense. besides indiana, there are seven other states that are not facing nor are in jeopardy of facing a health care crisis. of those, indiana is the only state that still adheres to the doctrine of contributory negligence in medical malpractice cases. there is no evidence to show that by adopting the doctrine of''modified" comparative fault that indiana will be sent into another medical care crisis. judging by the seven other states systems, comparative fault does not seem to be a factor at all. the most telling and only consistent element is the implemen­ tation of a punitive damages cap. indiana has a hard cap on all punitive and economic damages, while the other states cap only economic or non-economic damages. this places indiana in better shape on damages than the other states. while there is strong evidence for removing the unfair and archaic doc­ trine of contributory negligence from indiana law, achieving this goal will be much more difficult. the indiana supreme court has continued to uphold the text of the indiana code. absent the courts' willingness to overturn the legisla­ ture, the only route is for the legislature to amend the law. in order to accom­ plish this daunting task, a grass roots effort, supported by patient advocate groups, will need to pressure the legislature into giving patients a fair shot at recovery when they are harmed by the misdeeds of a physician. there will like­ ly be strong opposition from interest groups, backed by a strong lobby, to keep the unfair system in place. it provides the insurance companies and physicians an avenue to avoid liability altogether. the citizens oflndiana must speak out and remind the legislators of their purpose and function. the members of the 258. ld 136 indiana health law review [vol. 6:107 indiana general assembly represent the citizens of indiana, not the lobbyist and special interest groups. granular control of ehrs to overcome fragmented disclosure law: how policy choices for granularity will affect clinical care, impact secondary use of health information,and alter risks for patients and providers granular control of ehrs to overcome fragmented disclosure law: how policy choices for granularity will affect clinical care, impact secondary use of health information, and alter risks for patients and providers katherine drabiak-syed, jd* i. introduction ................................... 40 ii. disclosures of health information ................ 44 a. federal law ............................ 44 b. state law .................................. 47 1. healthlmedical information and records............ 48 2. sensitive records ............. .............. 50 iii. granularity and sensitive medical information ......... 54 iv. state hio models: indiana, new york, and arizona... 56 a. indiana .................................... 57 b. new york. ............................. ...... 58 c. arizona .................................... 60 v. how granularity can impact public health, research use, and patient trust ................. 62 vi. hies: a new market for wrongful disclosures and security breaches of patient information..... ..... 64 vii. implications of building hios with options for granularity, effects on clinical care, and potential provider liability ........................ ..... 68 viii. policy considerations and conclusion ...... ...... 71 drabiak-syed is a law and bioethics policy consultant to the indiana university center for bioethics. this publication was supported by a grant from the lilly endowment to the center for law, ethics & applied research in health information. its contents are solely the responsibility of the author and do not reflect the official views of the indiana university center for bioethics or the center for law, ethics & applied research in health information. indiana health law review i. introduction effective utilization of electronic health records (ehrs) offers many promises to both clinicians and patients in the clinical care setting. defined as a "repository of electronically maintained information about an individual's lifetime health status and health care," an ehr is longitudinal, comprehensive, and interoperable.1 a full ehr contains a vast amount of a patient's clinical information designed to reduce errors, improve patient care, facilitate clinical coordination, and monitor care quality.2 the information contained in an ehr gives providers a comprehensive reference of the patient's full medical history so providers may make more efficient and informed decisions during the course of care such as whether to order a test of procedure, whether a particular medication would counteract with any of the patient's current medications or drug allergies, and cross reference relevant information in the patient's medical history. 3 the aggregate information and its availability to providers decrease the number of tests to which the patient is subjected and lowers the risk of potentially problematic drug responses. 4 ehr systems also offer the potential to provide clinical decision support to physicians by checking patient medication interactions, 1 sharona hoffman & andy podgurski, e-health hazards: provider liability and electronic health record systems, 24 berkeley tech. l.j. 1523, 1530 (2009); mark rothstein, the hippocratic bargain and health information technology, 38 j.l. med. & ethics 7, 9 (2010) [hereinafter rothstein, e-health hazards]. 2 leslie pickering francis, the effects of health information technology on the physician -patient relationship: the physicianpatient relationship and a national health information network, 38 j.l. med. & ethics 36 (2010). 3 melissa goldstein & alison rein, consumer consent options for electronic health information exchange: policy considerations and analysis, 2, 61 (2010), available at http://healthit. hhs.gov/portal/server.pt/community/healthit-hhs-gov-privacy-and_sec urity/1147. 4 id. at 61; elana rivkin-haas, note, electronic medical records and the challenge to privacy: how the us and canada are responding, 34 hastings int'l & comp. l. rev. 177 (2011). 40 vol. 10:1 granular control of ehrs providing test recommendations, or offering suggestions for treatment options based on best practices guidelines.5 adoption of ehrs will offer significant savings to health care providers and reduce costs in the healthcare system. the american recovery and reinvestment act of 2009 (arra) invested $19 billion in computerized medical records in an effort to eventually reduce medical care costs while increasing effective patient care and protecting patient privacy. 6 the health information technology for economic and clinical care act (hitech act) encourages health care providers and physicians to adopt an ehr system before 2015 and contains funding incentives for ehr infrastructure and technology implementation.7 provider access to information contained in an ehr can eliminate costly inefficiencies, such as ordering redundant testing and diagnostic services, and the use of clinical decision support features allow providers to quickly identify illnesses and mitigate the potential for medical errors.8 as providers begin to utilize ehrs, evidence suggests that provider access to patient's complete records along with ehr clinical guidance will reduce costs by $142-371 billion annually.9 states that have taken the initiative and begun to build their health information exchanges (hies) face a number of regulatory and legal barriers to the implementation of policies and procedures governing the collection, disclosure, and use patients' medical information. health information organizations (hios) are faced with a fragmented architecture of federal and state law where many states permit the collection of general patient information to enter 5 jonathon roth, note, regulating your medical history without regulations: a private regulatory framework to electronic health record adoption, 91 b.u.l. rev. 2103, 2106-2109 (2011). 6 stephen weiser, breaking down the federal and state barriers preventing the implementation ofaccurate, reliable, and cost effective electronic health records, 19 annals health l. 205, 205-06 (2010). 7 id. at 206. 8 roth, supra note 5, at 2108-2109. 9 john hill et al., a proposed national health information network architecture and complementary federal preemption of state health information privacylaws, 48 am. bus. l.j. 503, 509 (2011). 2013 41 indiana health law review in an hie without additional patient consent, but some states contain additional provisions restricting the disclosure of sensitive medical information without additional patient consent, posing functional and operational uncertainties. these legal questions have prompted hios and policymakers to discuss whether to include sensitive information in the hie or whether to implement a system of granular control for sensitive patient information. each option and permutation related to the hio's treatment of sensitive information corresponds to differences in clinical care, the ability to use the data in the hie for research purposes, and potential provider liability in the clinical care setting. as more healthcare systems begin to adopt ehr technology and states continue building their health information organizations (hios) to manage ehrs, the sheer amount of patient information in health information exchanges (hies) and its utility and accessibility increases. digitalization of data and physician-patient interactions facilitates the ability to collect, store, replicate, and transmit information contained in the ehr by authorized persons involved in clinical care.10 in addition to clinical use of ehrs, hies offer great promise to public health officials and investigators who can use the information contained in ehrs for purposes such as quality assessment, public health reporting, and research to eventually return these findings into more efficient and effective clinical care." however, increasing the amount of persons who may have access corresponds to a higher potential for improper disclosures of patients' private medical information.12 furthermore, options for granularity means that physicians will not have access to patients' complete records, which may impair physician's ability to appropriately treat patients according to evolving standards of care and expose physicians to a new area of liability. part i of this article contains an overview of federal and state laws relating to the collection, use, and disclosure of 10 goldstein, supra note 3, at 53. 11 id. at 24-25. 12 id. at 52. 42 vol. 10:1 granular control of ehrs protected health information (phi) and two subsets of sensitive health information, specifically mental health records and substance abuse and treatment records. this portion of the article discusses the barriers to interstate interoperability and secondary uses of data in hies arising from varied state law approaches governing the disclosure of these records. part ii provides an overview of the policy movement toward granular control of sensitive information and corresponding considerations for clinical care. part iii discusses three hios and associated state law in indiana, new york, and arizona, which have each adopted varied methods of building an hio. this portion of the article outlines how these models answer the policy questions related to how patients participate in the hie, how the state approaches treatment of sensitive information, and potential tradeoffs to patient privacy, clinical care, and research associated with each policy choice. the next portion of the article examines long term issues connected to amassing patient information in hies and assesses specific considerations based on how the hie approaches integrating sensitive information. part iv discusses how the data in the hies could be used for public health and research purposes designed to return clinical care benefits to patients and highlights the synergy between respecting patient privacy and the ability to derive public health information. next, part v notes the growing potential for wrongful disclosures and security breaches of health information and asserts that the information contained in hies may become a target for wrongdoing, which increases the risk that patients may suffer adverse consequences that affect not only their finances and insurance, but also their future clinical interactions. lastly, part vi predicts how systems of granularity will affect a physician's ability to treat patients. hies that fully sequester sensitive information or keep sensitive information hidden in the hie may impair the physician's ability to effectively treat patients and correspond to an increase in provider liability and medical malpractice actions. 2013 43 indiana health law review ii. disclosures of health information states and hios building or expanding their hies must navigate federal and state law, which is both complex and quickly evolving. federal law and regulations set forth standards governing the uses of protected health information (phi), requirements for disclosing and sharing phi and security standards to safeguard the information. 13 state law expands and complements the federal floor for protecting the privacy of health information, setting forth additional requirements governing uses and disclosure of general medical information, and some states set forth distinct requirements for categories of sensitive medical information. a. federal la w the health insurance portability and accountability act (hipaa) privacy rule governs the uses and disclosures of phi, such as names, medical record numbers, social security numbers, and medical record information by covered entities including health care providers and health plans. 14 under the privacy rule, covered entities may not use or disclose phi without an authorization unless otherwise permitted or required by law.15 covered entities may use and disclose phi without an authorization for uses such as treatment, payment, and healthcare operations, and use a limited data set without an individual's authorization for research purposes and public health operations, and may always use or disclose for individual health information which has been de-identified.16 if a covered entity wishes to disclose and use phi for additional purposes not otherwise permitted, required, or exempted, the covered entity must obtain an authorization from the patient specifying how the phi will be used or disclosed, to whom the information will 13 see goldstein, supra note 3, at 40-42. 14 45 c.f.r. § 160.103 (2011); see goldstein, supra note 3, at 4244. 15 45 c.f.r. § 164.502(a) (2011). 16 45 c.f.r. § 164.506 (2011). 44 vol. 10:1 granular control of ehrs be disclosed, and the length of time the authorization is valid. 17 the hipaa security rule sets forth standards designed to protect the confidentiality and integrity of the information maintained, used, and transmitted by covered entities.18 under the security rule, covered entities must implement reasonable administrative, physical, and technical safeguards to secure electronic health information.'9 it provides specific technological guidelines designed to increase data security such as creating log-in systems accessible by password, using encryption programs, and auditing data access. 20 in 2009, congress passed the health information technology for economic and clinical care act (hitech act), which is designed to advance the use of health technology by funding incentives for healthcare providers to adopt an ehr system by 2015.21 importantly, the hitech act also set forth a second priority to use electronic health data to enhance the use of health information technology in healthcare through population health research and clinical research. 22 as states continue to build their hios, they face differing requirements for privacy rule compliance based on their functional purpose.23 if a covered entity enters 17 45 c.f.r. § 164.508 (2011). 18 martha tucker ayres, confidentiality and disclosure of health information in arkansas, 64 ark. l. rev. 969, 983 (2011). 19 45 c.f.r. § 164.302 (2011); 45 c.f.r. § 164.304 (2011); 45 c.f.r. § 164.306 (2011). 20 45 c.f.r. § 164.308; ayres, supra note 18, at 983. 21 weiser, supra note 6, at 206. 22 id. 23 see kari bomash, privacy and public health in the information age: electronic health records and the minnesota health records act, 10 minn. j.l. sci. & tech. 117, 121-122 (2009) (discussing using ehrs for public health purposes); see kenneth goodman, ethics, information technology, and public health, new challenges for the physicianpatient relationship, 38 j.l. med. & ethics 58, 59-62 (2010) (discussing using ehrs for surveillance programs and community health programs; see pickering francis, supra note 2, at 43-45 (discussing using ehrs to improve patient care and patient choices); 2013 45 indiana health law review patient information into a health information exchange (hie) to facilitate health care treatment and operations, the law as written does not require patients to authorize entry of their phi. 24 however, if the health information organization (hio) adopts the hitech act's second priority to use the health data for research purposes, then the hio may need patient authorization to use or disclose phi for particular research uses where the patient is identifiable. 25 an hio's future use of patient information poses at least one dilemma and becomes further complicated by vastly different state laws protecting the use and disclosure of types of health information that the hio may use or exchange for secondary purposes. currently, the use of ehrs is fragmented and disconnected, posing a confusing architecture of health records and creating dizzying permutations: whether a state contains an hio, which providers transmit information to that hio, whether the hio uses or contemplates using the information for secondary purposes, and whether the hio contains records from a singular state or exchanges records from multiple states. although the office of the national coordinator for health information technology promulgates a goal of ehr interconnectivity, the arra does not require federally funded systems to be functionally interoperable but rather requires that "interconnection be possible."26 the goal of future intrastate and interstate interoperability along with varying hio agendas and state law relating to disclosure requirements poses additional challenges for hies because providers and hios must understand the requirements set forth in federal law, the law of the operating state, and the law to where the information may be exchanged for clinical care or secondary purposes. 27 that is, information gathered see pickering francis, supra note 2, at 45 (discussing using ehrs for quality improvement purposes). 24 see goldstein, supra note 3, at 42-44 25 45 c.f.r. § 164.508. 26 mark a. hall, property, privacy, and the pursuit of interconnected electronic medical records, 95 iowa l. rev. 631, 635 (2010). 27 hill et al., supra note 9, at 531-532. 46 vol. 10:1 granular control of ehrs for clinical care purposes and entered into the state's hie may travel to another state that contains differing restrictions on the disclosure of specific subsets of information and varying standards on how that information may be used without further authorization from the original patient. b. state law hipaa's requirements establish a floor of protection for use and disclosure of individually identifiable information, which provides each state the ability to enact more stringent laws relating to general medical records or subsets of records that include sensitive categories of information. 28 states vary with regard to how they define terms such as medical record or medical information, to whom this information can be disclosed, for what purposes, what an individual's consent to disclose this information must contain, and the nature of exceptions for disclosure without consent.29 as more states begin to build their hios, the question arises whether entering patient information into a record locator system and physician access to that information constitutes separate additional disclosures or whether they are implicitly permitted disclosures that do not require additional patient consent. in addition to general medical information, some states set forth additional protections to guard the confidentiality of sensitive medical information. these states may require additional consent from patients to include types of sensitive records in the hie and limit subsequent disclosures of these records from the hie. this extensive disparity among states relating to defining permissible disclosures also poses questions of how to resolve these discrepancies and what model of interstate choice of law or preemption should govern during the interstate exchange of 28 see goldstein & rein supra note 3, at 40-42. 29 joy pritts, et al., privacy and security solutions for interoperable health exchange: report of state medical record access laws, at 3-2 (2009), http://www.healthit.gov/sites/default/files/ 290-05-0015-state-law-access-report-i.pdf. 2013 47 indiana health law review information.3 0 furthermore, some state laws carve out exceptions for disclosure restrictions to use medical information (sometimes inclusive of sensitive information) for research purposes, which poses several choice of law questions if the hio exchanges this information with other states. 1. health/medical information and records based on hipaa's standard, most states have adopted a model where a patient does not need to provide the treating physician authorization to use the patient's current medical record for treatment purposes and permits additional disclosure of medical information to directly consulting providers or excludes this transfer from the definition of disclosure. 31 many states specify that patient health care or medical records are confidential and place limitations on their disclosure for secondary purposes. some states permit the release of health or medical records for general research purposes, public health research, or scientific, medical, or public policy research. 32 the states that permit the disclosure of these records contain corresponding provisions designed to protect the confidentiality of the patients through various methods such as specifying that the researcher shall maintain the confidentiality of the records, 30 hill et al., supra note 9, at 531-32. 31 new york is one exception that requires patient consent for treatment, payment and healthcare operations. see n.y. comp. codes r. & regs. tit. 10, § 405.10(a)(6) (2012); n.y. educ. law § 6530(23) (mckinney 2012); n.y. comp. codes r. & regs. tit. 8, § 29 (2012). 32 see cal. civ. code § 56.10(c)(7) (west 2012) (noting that the disclosure of health/genetic information is permitted for certain research where the identity of patient protected); colo. rev. stat. ann. § 6-18-103 (repealed 2004) (discussing permissible releases of health information for research purposes, including genetic information, so long as the identity of the individual is not disclosed); 410 ill. comp. stat. ann. 520/5 (west 2012) (discussing a confidentiality provision in state public health law that outlines conditions and procedures specified for outside research); neb. rev. stat. ann. § 44-916(2) (west 2012) (permitting disclosures without the authorization of the individual for the performance of several activities, including "scientific, medical or public policy research.") vol. 10:148 granular control of ehrs the researcher must protect the patient identities, or the researcher may not disclose patient identities to external entities not involved in the research or must provide written assurances of confidentiality33 a minority of states allow health care providers to release health and medical records containing the patient's identifying information without the patient's authorization for research if an irb approves the research project 34 or the irb determines the project satisfies a list of criteria.35 as hios collect patient information and implement a record locator system (rls), some privacy advocates have argued that entry of patient information into the hie and even patient listing in the rls requires patient consent because these are additional disclosures outside the traditional one-to-one treatment relationship between physician and patient.36 the onc tiger team recommends that directed exchange of medical information solely for treatment does not require consent unless otherwise specified in law or custom. 37 however, privacy activist 33 see utah code ann. § 26-33a-109 (west 2012) (discussing how the collection of permitted health data must be kept confidential and a written agreement to protect data is required); cal. civ. code §56.10(c)(7) (west 2012) (noting that the disclosure of health/genetic information is permitted for certain research where the identity of patient protected); colo. rev. stat. ann. § 6-18-103 (2003) (discussing permissible releases of health information for research purposes, including genetic information, so long as the identity of the individual is not disclosed) (repealed 2004); wis. stat. ann. § 146.82 (west 2012) (discussing how the release of medical information for research permitted where identity of subject is protected). 34 n.d. cent. code ann. § 23-01.3-02 (west 2012) (use of biomedical health information is permitted for research approved by an irb or for public health research where identity of patient is protected). 35 wash. rev. code ann. § 70.02.050 (west 2012) (stating that disclosure without patient authorization is permitted for research approved by an institutional review board that has met certain criteria). 36 deborah peel, written testimony before the hit policy committee (sept. 18, 2009) [hereinafter peel, written testimony], http://epic.org/privacy/medical/peelppr%20written%20testimony%20 hit%20policy%20committee.pdf. 37 paul tang, recommendations from the privacy & security tiger team to the hit policy committee, 9 (sept. 1, 2010) [hereinafter hit policy committee letter], http://healthit. 2013 49 indiana health law review deborah peel argues that ehr systems are fundamentally different than paper records because of higher privacy and security risks, and maintains that providers should obtain consent to access patient information in an hie. 38 in new york, the new york civil liberties union has argued that state law requires patient consent at two points: (1) to add patient information into the rls and hie, and (2) when a physician seeks access to patient information in the hie.3 9 the potential points of consent-entry into the rls, consent for provider access, or consent for secondary uses of the information pose a potentially confusing situation for hios exchanging information that have differing policies regarding what action constitutes a disclosure and when the patient must consent. furthermore, hios operating in states without research provisions that wish to utilize the exchange only for clinical care purposes but exchange records across states would need to establish a method of segregating medical records from being used in other states for secondary purposes after the initial clinical care disclosure. 2. sensitive records many states provide additional statutory provisions governing the privacy and disclosure of subsets of sensitive health information such as mental health records, substance abuse treatment records, genetic information, health records relating to domestic violence, or reproductive hhs.gov/portal/server.pt/gateway/ptargs_0_0_6011_1815_17825_43/ht tp%3b/wi-pubcontent/publish/onc/public-communities/_content/ files/ hitpctransmittal-p-s tt_9_1_10.pdf. 38 deborah peel, your medical records aren't secure, wall st. j. (mar 23, 2010) [hereinafter peel, your medical records aren't secure], available at http://online.wsj.com/article/sb1000142405274870358090 4575132111888664060.html. 3 corrine carrey & gillian stern, protecting patient privacy. strategies for regulating electronic health records exchange, new york civil liberties union (mar. 2012), available at http://www. nyclu.org/files/publications/nyclupatientprivacy.pdf, see also bomash, at 127 (2009) (discussing patient consent to enter information into the rls). vol. 10:150 granular control of ehrs care information.40 in general, some states contain provisions stating that a particular type of record is confidential and the patient must explicitly consent to its disclosure. 41 states differ with regard to what types of information its statutes afford additional protection, whether it affords additional protection for one or several subsets of information, and the scope of exceptions to the disclosure provisions. many states that restrict the disclosure of sensitive information provide disclosure restriction exceptions for public health purposes, research purposes, as well as exceptions where required by law, such as for reporting purposes.42 navigating the variation among state law's additional disclosure requirements has prompted federal guidance from the onc's tiger team and scholars recommending that providers sequester sensitive information and separate it from the rest of the patient record or provide granular control over these subsets of medical information. 43 in general, drug and alcohol records including patient identifying information that are maintained in connection with the performance of any substance abuse treatment or prevention program are confidential and require patient consent to release these records. under the comprehensive alcohol abuse and alcoholism prevention, treatment, and rehabilitation act, federal law places limitations on 40 see 42 c.f.r. § 59.11 (2012) (confidentiality for patients receiving federally funded family planning services); pritts, supra note 29, at 3-15 to 3-18; goldstein, supra note 3, at 48 (discussing the federal and state requirements for substance abuse and treatment records). 41 see for example new york, who provides additional protections for disclosing genetic information, n.y. civ. r. law §79-1 (mckinney 2012), mental health information, n.y. mental hyg. law § 33.13 (mckinney 2012), and substance abuse and treatment information, n.y. pub. health law §§ 3371, 3372 (mckinney 2012). 42 ark. code ann. § 20-09-304 (west 2012) (providing that medical information may be released for research where identity of patient protected). 43 rothstein, e-health hazards, supra note 1, at 11-12; see also hit policy committee letter, supra note 37 (providing recommendations to hhs on privacy and security policies and practices); 2013 51 indiana health law review disclosures of patient information for individuals in drug or alcohol abuse treatment programs that receive federal funding, and some states provide additional limitations on disclosure of substance abuse records. 44 some state laws explicitly require that during treatment, providers must uphold the confidentiality of patient information and not disclose such information to external parties to preserve the confidences of the patient.45 several states contain provisions that allow disclosure of this information from non-federally funded programs including the patient's identifying information without the patient's authorization or consent for specific purposes, such as releasing the records to qualified personnel for the purpose of conducting scientific research,46 or releasing the records for research into the causes and treatment of drug and alcohol abuse.47 some states place additional restrictions on this disclosure of records and specify that the records may not identify the patient or contain identifying information,48 while states such as maine allow the researcher access to the identifying information as long as this information is not published.49 mental health records including patient identifying information that are maintained in connection with the performance of evaluation and treatment programs are confidential and states generally limit disclosures of this 44 see 42 c.f.r. § 2.3(a) (2011). 45 supra note 32. 46 see cal. health & safety code § 11845.5 (west 2012) (stating that the disclosure of substance abuse records permitted for research if patient cannot be identified); see also cal. health & safety code § 11977 (2003) (repealed 2004). 47 see s.d. codified laws § 34-20a-91 (2011) (repealed 2012) (the release of records from alcohol and drug treatment permitted for research where patient identifying information not disclosed). 48 see cal. health & safety code § 11845.5 (west 2012) (the disclosure of substance abuse records permitted for research if patient cannot be identified); mich. comp. laws ann. § 333.6113 (west 2012) (using substance abuse records for research where identity of patient not disclosed). 49 see me. rev. stat. ann. tit. 5, § 20047 (west 2012) (stating that the registrations and other records of treatment facilities for substance abuse should remain confidential although the information may be released for research purposes). 52 vol. 10:1 granular control of ehrs information. similar to substance abuse and treatment records, state law and professional guidelines maintain that during treatment providers must uphold the confidentiality of patient information and not disclose such information to external parties.50 the american medical association's code of medical ethics and the american psychological association's ethical principles of psychologists and code of conduct each set forth a professional obligation to protect a patient's confidential information learned during treatment, noted the importance of confidentiality in patient trust and effective care, and discussed limitations on disclosure. 51 some state laws permit research use of mental health records, and most of those states contain provisions designed to protect the identity of the patients by specifying that the researcher must keep the identities of the clients confidential and may not further disclose any identifying information 52 or must provide assurances that the anonymity of the patient will be protected (alaska).53 states differ with regard to who may access and use these records and identifying information, ranging from only the state secretary of health or designee (florida), to qualified personnel (district of columbia), to a person doing research or conducting health statistics as part of a bona fide research program (alaska).54 50 patient confidentiality, american medical association, available at http://www.ama-assn.org/ama/pub/physician-resources/ legal-topics/patient-physician-relationship-topics/patientconfidentiality.page (last visited nov. 4, 2012); ethical principles of psychologists and code of conduct, american psychological association, available at http://www.apa.org/ethics/code/ index.aspx (last visited nov. 4, 2012). 51 id. 52 see d.c. code § 7-242 (2010) (amended 2012) (describing the permissible uses and disclosures of health information, including certain types of research); d.c. code § 7-1203.05 (west 2012) (providing a research exception to general rule of confidentiality of health info about mental health patients); fla. stat. ann. § 394.4615 west (2012) (permits disclosure of mental health records for research purposes). 53 alaska stat. ann. § 47.30.845(4) (2012) (stating that the disclosure of mental health data to a researcher is permitted when anonymity of the patient assured). 54 id. 532013 indiana health law review when an hio develops its policies relating to sensitive patient information, it would need to understand a significant amount of legal, policy and procedural information: what type or types of sensitive records are involved; whether the content of the records will be used solely for clinical care or held in the hie for potential research; state law where the initial treatment occurred relating to disclosing sensitive information for clinical care, to an hio, and for secondary purposes; law of the destination state relating to disclosing sensitive information for clinical care, to an hio, and for secondary purposes. improper information segmentation or confusing statutory preemption analysis could potentially lead to thorny scenarios where one state strictly limits the disclosures of sensitive information but exchanges this information to another state with vastly different laws. these questions have prompted policymakers and scholars to rethink whether and how to include or permit access to patients' sensitive information in hies and whether granular control of sensitive medical information constitutes a policy alternative. iii. granularity and sensitive medical information the office of the national coordinator for health information technology's hit policy committee has asserted that a form of granular control over health data can protect the confidentiality of narrow categories of sensitive health information while fostering patient autonomy, promoting trust in medical providers, and building confidence in the growing use of hit.55 policymakers recognize that patients would like to exert some influence over who views this information and have discussed various systems of granular control over sensitive information.56 proposed mechanisms for asserting granular 55 advancing privacy and security in health information exchange, hhs.gov (sept. 12, 2011), http://healthit.hhs.gov/portall server.pt/community/healthit hhs-gov privacy-and security/1147 (last visited oct. 18, 2012) [hereinafter advancing privacyl. 56 goldstein, supra note 3, at 7-10, 19 (discussing types of granularity by data type, provider, time range, or purpose). 54 vol. 10:1 granular control of ehrs control and increasing patient privacy vary, each solution with its own tradeoff to the provision of comprehensive and effective clinical care as well as implications for research. the new york civil liberties union has taken the position that hios should sequester records and make them available to subsequent providers through the hie only with specific patient consent at two points: prior to entering the information into the hie and prior to the disclosure to the requesting physician.5 7 building upon this notion of controlling disclosures, professor pickering francis has suggested that hios should instead include all patient information in the hie, but mask and flag sensitive information, so providers are aware of its existence when they view the patient's full record and can request patient consent to view the entire record.58 despite an increase in patient privacy, systems of granular control and mechanisms to exclude sensitive information from an hie hold several drawbacks. given the amount of different types of sensitive information and the methods to offer granular control over its access, patients may end up facing too many choices, resulting in confusion or exercise of meaningless choice.59 granular control of sensitive information may pose logistical feasibility setbacks for providers accommodating different patient choices and attempting to track disclosures of this information should the patient revoke authorization for release of the information.6 0 whether an hio excludes sensitive information from its exchange or includes it in fully masked form, both scenarios carry highly problematic implications for clinical care. 61 the type of information involved in sensitive records can provide physicians crucial information to the patient's state of mind, whether the patient's decision-making capacity is influenced by external 57 carrey, supra note 39, at 16-17. 58 francis, supra note 2, at 40-42. 59 mark rothstein, debate over patient privacy controls in electronic health records, bioethics forum (february 17, 2011), http://www.thehastingscenter.org/bioethicsforum/post. aspx?id=5139. 60 weiser, supra note 6, at 210. 61 id. at 209-10. 2013 55 indiana health law review factors (mental health struggles or substances), or whether the patient is taking or using any contraindicated drugs. this scenario results in a thorny dilemma; that is, a patient chooses to exclude or hide some subsets of information because of its sensitive nature, yet patients who have mental illness or struggle with substance abuse issues both of which are often lifelong residual struggles may be most in need of attentive and complete care. furthermore, sensitive information would be especially relevant to providing comprehensive care in an emergency situation, contrary to the new york civil liberties union's assertion. 62 both the pace of care and potential for life threatening conditions mean that missing a piece of sensitive information about the patient could conceal the patient's underlying condition. imagine the following two patient scenarios: (1) giving oxycodone to patient a with an excruciating backache; and (2) respecting patient b's religious request to refuse a life saving blood transfusion after an attempted suicide. however, imagine if the physician could have accessed sensitive records for these two patients to find that patient a's excruciating pain arose from illegal substance abuse withdrawal and patient b had a history of religious guilt, which fueled his depression and suicide attempts. if ehrs are designed to enhance clinical care and provide physicians the information necessary to make the most informed decisions, then sensitive information may be especially crucial in emergency situations. iv. state hio models: indiana, new york, and arizona several states have worked to construct their ehr systems by varying methods such as building a statutory framework or promoting an hio that promulgates policies aligned with current state law. 63 as states continue to expand or initiate their hios, they must consider: (1) current state law relating to disclosing medical information 62 carrey, supra note 35, at 15. 63 see goldstein, supra note 3 (discussing state hios in operation and models of consent). 56 vol. 10: 1 granular control of ehrs and sensitive records; (2) how patients will participate in the hie and the issue of consent; (3) at what points the hio or provider will obtain consent; and (4) determining access to patient records in the hie and whether the records will be used exclusively for clinical care or also for secondary purposes. the following section examines three models in indiana, new york, and arizona, assesses policy choices, and examines potential tradeoffs. a. indiana indiana state law sets forth details for the construction of a corporation to build and manage a statewide electronic health information exchange. 64 indiana's statutory law is comprehensive, specifically addressing the duties of the corporation, its purpose, and directions for its operation. the indiana legislature directed that the health information exchange should "improve the health of the citizens of indiana" by designing and implementing both an exchange of clinical health information as well as planning and facilitating research activities.6 5 indiana resolves the question of whether the patient must consent for disclosures by classifying patient health records as the providers' property. 66 under indiana law, providers may use a patient's original health record without specific authorization for a number of "legitimate business purposes" including entering the patient record into the indiana health information exchange (ihie) or disclosing to another provider, for "scientific, statistical, and educational purposes," or "data aggregation projects" by the indiana hospital trade association.67 the ihie has incorporated the state's comprehensive statutory scheme to create a system that connects over ninety hospitals and healthcare providers throughout the state with a flow of 64 ind. code ann. § 5-31-6-1 (repealed 2012). 65 ind. code ann. §§ 5-31-6-1, 5-31-1-1, 5-31-6-2 (repealed 2012). 66 ind. code ann. § 16-39-5-3 (west 2012). 67 id. 2013 57 indiana health law review health data. 68 state law relating to sensitive records follows two differing standards. state law defines mental health records as confidential and that notes that they generally may only be disclosed with consent, but references an exception that mental health records may be disclosed without consent for "legitimate business purposes," which as defined above, includes disclosure to the ihie. 69 indiana references and follows federal law for the disclosure of alcohol and drug abuse patient records. 70 ihie has generally been regarded as a positive model for initiating and building an hie marked by efficiency and ever increasing expansion.7' indiana approaches each policy question by systematically addressing them by statute. however, indiana law also provides for abolishment of the corporation in 2015, leaving operational questions open to ihie and future legislation. additionally, privacy advocates and legal scholars have criticized the concept of operational models that do not obtain patients' affirmative consent to use health information from an hio for research purposes. 72 privacy advocates may also take issue with the statutory allowance to disclose mental health information for research purposes without additional patient authorization. b. new york new york state law is scattered through various sections of code, does not address requirements or guidelines for a health information exchange directly, and contains 68 about ihie, indiana health information exchange, http://www.ihie.org/about/ default.php (last visited oct. 18, 2012). 69 ind. code ann. § 16-39-2-3 (west 2012). 70 ind. code ann. § 16-39-1-9 (west 2012). 71 deanna porgorelc, lessons from a state at the front lines of health information exchange, medcitynews.com (april 6, 2012, 10:29 am), http://medcitynews.com/2012/04/lessons-from-a-state-at-the-frontlines-of-health-information-exchange/. 72 peel, written testimony, supra note 36; see also mark rothstein, improve privacy in research by eliminating informed consent? iom report misses the mark, 37 j.l. med. & ethics 507 (2009) [hereinafter rothstein, improve privacy]. 58 vol. 10:1 granular control of ehrs potentially ambiguous and confusing language.73 one notable element in new york law is that unlike hipaa and most other states, patients must provide consent to disclose their medical records even for treatment purposes (except in an emergency).74 founded in 2006, the new york ehealth collaborative (nyec) is the state's non-profit entity that has worked to develop policies and standards for health information exchange in the state and coordinate the creation of a network to connect state providers. 75 nyec's focus has been on facilitating connection and continuity between the regional health information organizations (rhios) in the state for clinical care, although state statute and nyec policies do discuss using de-identified data for research purposes.76 in an effort to clarify state law and set forth policy stances, the nyec has issued recommendations for consumer consent policies in addition to outlining comprehensive operational standards.7 7 nyec policy instructs participating providers to enter patient information into the rls and exchange, and subsequent providers must obtain consent from patients to access the information.7 8 under nyec policy and state law, providers may choose whether to enter sensitive information as permitted by law into the exchange and providers may 73 see new york health information exchange operational plan, nyehealth.org, at 72-75 (oct. 26, 2010), http://nyehealth.org/images/ files/file repositoryl6/pdf/nyshie-operational-plan_2010.pdf [hereinafter new york health]. 74 n.y. comp. codes r. & regs. tit. 10, § 405.10(a)(6) (2012); see recommendations for standardized consumer consent policies and procedures for rhios in new york to advance interoperable health information exchange to improve care, new york ehealth collaborative 1, 73 (nov. 2008), http://nyehealth.org/images/files/ filerepositoryl6/pdflconsentwhitepaper_ 20081125.pdf [hereinafter consumer consent policies]. 75 about us, new york ehealth collaborative, http:// nyehealth.org/about-nyec/ (last visited nov. 5, 2012). 76 consumer consent policies, supra note 74, at 24. 77 id.; new york health, supra note 73. 78 see consumer consent policies, supra note 74, at 22-23 (noting that one-to-one direct exchanges are not subject to standard paper consent requirements); see also n.y. pub. health law § 18(1)(e) (2012); n.y. pub. health law § 18(6) (2012). 2013 59 indiana health law review access the information through the exchange by obtaining patient consent.79 in march 2012, the new york civil liberties union published a position paper criticizing perceived legal and policy shortcomings of nyec's operational policies.80 nyclu challenged nyec's interpretation of state law relating to consent, arguing that initial inclusion of patient information in the exchange also requires consent. although physicians must obtain consent to view patient information in the exchange, participating providers enter patient medical information into the exchange without patient consent and patients cannot opt-out of the rls. furthermore, nyec's comprehensive records means there is no formal mechanism for patients to limit sharing stigmatizing sensitive information such as substance abuse records or mental health treatment if they participate in the exchange. in april 2012, the new york department of health and the new york ehealth collaborative established the state health information network of new york policy committee to examine these and numerous other concerns over the state's current policies and procedures governing the exchange.8 ' c. arizona sparked by gubernatorial order in 2005, arizona has been working to develop the state's hio through legislation and partnership with the arizona health-e connection (ahec). arizona has passed comprehensive legislation directly addressing policies and procedures for a working hio in the state, taking note of recent policy discussions relating to consent and granular control options for sensitive information. ahec is a public-private partnership working to facilitate the design and implementation of a 7 see consumer consent policies, supra note 74, at 21, 28; new york health, supra note 73, at 73; n.y. mental hyg. law § 33.13. 80 carrey, supra note 39. 81 nicole lewis, new york moves to protect health data privacy, informationweek.com (april 5, 2012), http://www.informationweek. com/news/healthcare/security-privacy/232800368. 60 vol. 10:1 granuiar control of ehrs statewide hie, which is still in its initial stages.82 arizona state law sets forth a specific statutory scheme for the hio's governance and policy operations. 83 under arizona law, the hio must provide notice to patients to inform them that it collects individually identifiable health information, who may have access to this information, for what purposes, and how the patient may opt-out of the hie.8 4 participating providers will enter patients' information into the exchange and patients have the opportunity to opt-out.85 patients may also choose to partially opt-out by requesting that a particular provider withhold its patient information from the hie.86 state law mandates that the hio must implement a technologically functional system for segregating or sharing health information by 2015.87 the hio may disclose the individual's identifiable health information as long as the disclosure comports with hipaa, but may not transfer individually identifiable or deidentified information for research unless the patient provides consent.88 arizona's extensive and specific legislation incorporates recent policy discussions relating to promoting patient education about hios and providing patients with options for granular control of sensitive information. arizona's system sets forth the intention that patients actually understand the existence and the reason for the hio and can build its enrollment by automatically entering patient information. arizona has also taken note of patients' desire to limit some categories of information from the hie, yet this system may undermine clinical care if providers are not aware that a patient's record from the hie is incomplete and missing crucial pieces of information that would influence their decision-making. lastly, arizona's provision 82 what is arizona heath-e connection?, arizona health-e connection, http://www. azhec.org/ (last visited may 23, 2012). 83 ariz. rev. stat. § 36-3801 (2012). 84 ariz. rev. stat. § 36-3804 (2012). 85 ariz. rev. stat. §§ 36-3802, 36-3803 (2012). 86 ariz. rev. stat. § 36-3803. 87 ariz. rev. stat. § 36-3807 (2012). 88 ariz. rev. stat. § 36-3805 (2012). 2013 61 indiana health law review for the disclosure of health information provides two potentially conflicting standards and may pose a confusing barrier to secondary uses of data in the hie. v. how granularity can impact public health, research use, and patient trust as hios examine policy choices relating to consent models and options for granularity, they must also consider how these permutations and will intersect with long terms goals of the hio. if the hio or state law adopts the hitech act's objective to use patient information for research, policymakers must be cognizant of the delicate interplay between using robust patient data (including sensitive information) for research purposes while preserving patient trust, maintaining their privacy, and minimizing potential breaches of that sensitive information. information amassed in the hie could be used for a variety of secondary purposes including quality improvement, public health, and research.89 public health researchers could use patient information in the hie for health assessment, promotion of population health, and policy development.90 public health agencies could use the information in hies for tracking and minimizing the spread of disease, as well as aiding in disaster planning efforts.9 1 health services researchers could track patient information in the hie to examine incidence and prevalence of disease and treatment outcomes to gather data to assist in more effective treatment of disease. 92 however, if hios by default policy fully exclude all sensitive information and do not enter it into the hie, then researchers will be hindered from using a valuable potential set of data that could otherwise be accessible to researchers by a consent mechanism. if hios provide patients the option to fully exclude categories of patient information from the hie, then patients' varied choices to include or exclude their 89 francis, supra note 2, at 44. 90 bomash, supra note 23, at 120. 91 id. at 121-22. 9 2 id. vol. 10:162 granular control of ehrs sensitive information will carry over to unrepresentative data sets for these categories of sensitive diseases and conditions. 93 if hios provide patients options for granular control by including masked and flagged sensitive information in the hie, the hio could develop policies and procedures relating to patient consent and researcher access to that information, providing more representative data sets and potential public health and research benefits. indeed, professor goodman argues that physicians have a duty to use patient information for public health purposes and contribute to knowledge that will instruct future clinical care. 94 importantly, patients must trust that the hio will not misuse the patient information it holds or clinical care, potential public health advances, and research benefits will suffer.9 5 health law attorney kari bomash has discussed extensively the synergy between patient privacy and the ability to derive public health information.96 if patients do not believe the hio has provided appropriate choices and safeguards for their private and sensitive medical information for secondary uses, they lose trust in the provider and hio. 97 some proposals argue that we must override patients' desire to withhold their health information for research because the public simply cannot appreciate the benefits their medical information holds for research and mere use of health records does not pose palpable harm to the individual patient.9 8 such thinking is not only remarkably paternalistic and offensive, but ignores the delicate balance of trust sustaining the evolving 93 see barbara evans, much ado about data ownershio, 25 harv. j.l. & tech. 69, 76 (2011) (discussing the use of large datasets in large scale informational research and the impact of individual refusal). 94 goodman, supra note 23 (arguing that physicians have a duty to use patient information for public health research and return these results to patients in the form of better clinical care). 95 bomash, supra note 23, at 121-22. 96 id. at 120-23. 97 id. at 121-22; rothstein, improve privacy, supra note 72, at 51011. 98 franklin g. miller, research on medical records without informed consent, 36 j.l. med. & ethics 560, 561-65 (2008). 2013 63 indiana health law review physician-patient relationship in an age of growing health information technology as well as growing risks of wrongful disclosures (discussed infra section vi). as professor rothstein has aptly noted, if patients feel betrayed by their providers and believe their privacy is compromised, they may become anxious, withhold critical information from their provider, and become reluctant to seek care.99 professor rothstein correctly emphasizes that it is good public policy to promote public health, but it is also imperative that we work to prevent nonmedical harm to patients such as embarrassment and stigma.10 0 importantly, the populations with the most precarious trust such as those with stigmatizing health conditions and minority populations facing high rates of chronic disease may be most in need of the efficient and effective clinical care and research updates that hios can eventually provide. vi. hies: a new market for wrongful disclosures and security breaches of patient information as hios amass medical information, including potentially stigmatizing categories of sensitive information, privacy advocates and policymakers have discussed the growing potential for wrongful disclosures and security breaches of this information.101 by nature and design, ehrs contain comprehensive information relating to patient history, patient demographic information, and patient identifying information including as social security number and billing information. unlike paper records that may contain pieces of information on select patients in a physical location, ehrs are digitally stored in the aggregate, which eases the ability of an individual to download and replicate the information.102 the sheer amount of information contained in the hie including 99 rothstein, improve privacy, supra note 72, at 510. 100 rothstein, e-health hazards, supra note 1, at 11. 101 peel, your medical records aren't secure, supra note 38; bomash, supra note 23, at 122. 102 keith a. bauer, privacy and confidentiality in the age of emedicine, 12 j. health care l. & pol'y 47, 52 (2009). vol. 10:164 granular control of ehrs names, social security numbers, billing information, and comprehensive medical information creates a new market for a variety of wrongdoing by businesses and opportunistic individuals. this increase in the amount of information available in one electronic location requires an evolving analysis of privacy and security risks, and the recognition that thieves may begin to calculate and target the large collection of medical information held by hios. 03 specifically, hios that automatically include all patients in the rls and patient information in the hie should explain risks of potential breach to patients. 104 hios that include categories of sensitive information in the hie, even if hidden and masked in the system, should also take care to communicate the potential for wrongful disclosure of this sensitive information. examples of wrongful disclosures range from isolated incidents involving one or a few medical records, to unintentional system security breaches, to large-scale calculated breaches. healthcare employees may wrongfully disclose medical information for personal gain or curiosity. 105 numerous headlines have described how employees mistakenly published patient records on the internet or lost a usb key, allowing unauthorized individuals access to highly personal information.106 the amount of patient information in hies also opens a market for discriminatory use of medical information by employers and insurers seeking to employ only healthy employees or attempting to reduce costs.10 7 patients with sensitive medical conditions or chronic health conditions may be especially wary of hios holding their information if they 103 consolidated amended class action complaint at 6, 21-22, gaffney v. tricare management activity, no. 1:11-cv-01800-rlw (d.c. cir. feb. 21, 2012), available at http://cdn.govexec.com/medial gbc/docs/pdfs edit/031412bbla.pdf [hereinafter tricare complaint]. 104 see stanley c. ball, ohio's 'aggressive" attack on medical identity theft, 24 j.l. & health 111, 123-29 (2011) (discussing security breach and notification rules); hoffman, supra note 1, at 1555-61. 105 ayres, supra note 18, at 970-72. 106 see generally ayres, supra note 18; ball, supra note 104, at 114. 107 bomash, supra note 23, at 122; ayres, supra note 18, at 973. 2013 65 indiana health law review believe employers and insurers could gain (even unauthorized) access to these records. finally, individuals can steal information by obtaining the physical source, such as a computers or hard drive, or illegally hack into information stored in an electronic system. 0 8 one recent breach exemplifies the growing risk of security breaches and the sheer number of potentially affected individuals. in september 2011, tricare, which provides health benefits to the military and their families, reported a massive security breach affecting almost five million beneficiaries.109 according to media reports, the breach occurred through the theft of backup computer disks holding addresses, health information, and social security numbers." 0 this incident is particularly notable not only because of the astounding amount of victims affected by the breach, but also the factual circumstances surrounding the theft. plaintiffs allege that the incident constituted a carefully calculated, targeted, and executed attempt to steal the specific information contained in the backup disks, which plaintiffs estimated to be worth billions of dollars.1 1 1 media reports show both large-scale data breaches and isolated incidents have resulted in identity theft, and the newer form of identity theft, medical identity theft. 112 bad actors may hack into storage systems to gain access to patients' personal and medical information to sell at a hefty price on the black market, leaving these victims to investigate and mitigate damage to their finances, credit, and even medical records and insurance.113 apart from general identity theft, individual medical identity theft 108 ball, supra note 104, at 114. 109 privacy and security: individuals affected by tricare data breach allege possible fraud, ihealthbeat.com (march 15, 2012), http://www.ihealthbeat.orglarticles/2012/3/15/individuals-affected-bytricare-data-breach-allege-possible-fraud.aspx (last visited nov. 5, 2012). 110 id. 111 tricare complaint, supra note 103, at 21-22. 112 katherine sullivan, but doctor, i still have both feet! remedial problems faced by victims of medical identity theft, 35 am. j.l. & med. 647 (2009); ball, supra note 104, at 117-20. 113 sullivan, supra note 112, at 650-52. vol. 10: 166 granular control of ehrs occurs when an individual assumes another person's identity to receive medical services and bills the victim's insurance. 114 individuals may also steal information from multiple parties to commit medical identity theft and defraud third party payers by billing the victim's insurance for services and procedures that the victim did not actually receive. 115 in addition to sorting out fraudulent billing claims, victims may face negative implications for their credit as a result of billing errors. furthermore, insurers processing the fraudulent claims may bill the victim for deductibles, co-payments and other costs. 116 the victim's insurance company may also deny or delay coverage of benefits to the victim, or even refuse further benefits if the company decides the patient has exhausted the policy's coverage. 117 problematically, providers likely add the fraudulent information into the victim's medical record, which impairs subsequent providers' ability to properly treat the real patient and can result in dangerous medical errors.118 as hios continue to build their presence, the possibility that the provider enters the identity thiefs fraudulent information into the permanent comprehensive patient record becomes even more likely, and raises the possibility that the fraud will directly impact the victim's subsequent medical care. integration of fraudulent information into the victim's patient chart is especially dangerous if care occurs during an emergency situation where the victim cannot notice and correct the errors.1 9 114 id. at 650-51. 115 id. 116 ball, supra note 104, at 117-20. 117 id. 118 sullivan, supra note 112, at 650-52. 119 id. 2013 67 indiana health law review vii. implications of building hios with options for granularity, effects on clinical care, and potential provider liability adoption of ehrs and interoperable hies aims to allow providers to more effectively and efficiently care for their patients. by definition, a provider should be able to access a patient's ehr to locate longitudinal and comprehensive information about the patient. however, adopting a system of granularity that fully excludes patient information from the hie (either never entered into the hie or its existence fully hidden from subsequent providers) does not satisfy these specific clinical care aims of an hie. furthermore, a physician who accesses a patient's records from the hie may mistakenly believe the record is complete, leading the physician to make inappropriate treatment decisions or prescribe contraindicated medications. providers must be aware of variable clinical duties and potential liability connected to these choices for granular control. this scenario could potentially expand physician liability for medical malpractice in negligence actions for physicians at two points of care interacting with the patient, particularly where physicians hold discretion in deciding whether or not to add sensitive records to the hie or access sensitive records from the hie. professors hoffman and podgurski have extensively discussed liability implications for physicians arising from the adoption of ehrs, noting that shifting standards of care and the sheer amount of information physicians must process for effective care poses significant challenges for physicians attempting to navigate clinical care decisions. 120 in a traditional negligence action, patients who believe the physician was negligent must establish: (1) a duty of care owed by the defendant to the plaintiff; (2) breach of that duty through conduct that fails 120 see hoffman, supra note 1 (discussing physician and institutional liability associated with the adoption of ehrs); see also sandeep mangalmurti et al., medical malpractice liability in the age of electronic health records, 363 new eng. j. med. 2060 (2010) (discussing the evolution of medical malpractice liability relating to the adoption of ehrs). 68 vol. 10:1 granular control of ehrs to meet the applicable standard of care; (3) harm or injury; and (4) a causal link between the breach of duty and the plaintiffs injury.121 imagine the following scenario: patient could show that physician a who treated patient for sensitive condition owes patient the duty to consider the impact of not entering a part or the whole sensitive treatment record into the hie as part of patient's ongoing care and management of sensitive condition. if more physicians begin to enter sensitive records into hies, this practice could become the new standard of care, and physician a's decision to withhold sensitive record from hie may constitute a breach of that duty owed to patient. 122 if patient can show that but for physician a's decision to exclude sensitive record that patient would not have sustained an injury (such as medication interaction or contraindicated care) in a subsequent clinical care encounter with physician b and patient actually sustained such an injury, patient could bring a medical malpractice liability lawsuit against physician a for negligence. patient could similarly apply this rationale to subsequent treatments by physician b. if physician b does not request patient's sensitive records separately, through the hie if the sensitive records are masked, or fails to integrate the information from sensitive records and the failure to consider patient's sensitive records proximately causes patient harm, patient may also bring a negligence action against physician b. in addition to one-on-one interactions between physicians and patients, adopting a system of granularity that fully excludes patient information from the hie or enters sensitive information based on provider or patient discretion carries implications for anticipated features of ehrs relating to clinical decision support. in theory, medication dosages, best practice guidelines, and treatment 121 w. page keeton et al., prosser & keeton on the law of torts (5th ed. 1984). 122 see thomas mclean, emr metadata uses and e-discovery, 18 annals health l. 75 (2009) (discussing use of emr metadata for medical malpractice liability to establish physician knowledge and practice, and to use metadata to show general custom in the profession). 2013 69 indiana health law review suggestions are based on gathering clinical data from a broad representative spectrum of patients to understand the effectiveness of particular treatments and courses of action.123 systems for granularity could skew collection of patient data in two ways. first, an hio could use a selfselecting sample of data based on some patients who choose to include their sensitive information in the hie, resulting in an unrepresentative sample population, which would correspondingly distort data outcomes. second, an hio may choose to exclude all patient data relating to sensitive conditions from clinical decision support features, which would result in clinical decision support data that cannot account for the interplay between patients' sensitive conditions and other medical needs. such a system may recommend inappropriate medications that would be contraindicated for some patients based on other co-existing conditions such as depression or alcohol addiction, or suggest an incorrect diagnosis based on a patient's symptoms that could otherwise be attributed to the patient's sensitive co-existing condition. to minimize liability, providers who utilize clinical decision support guidelines should proceed cautiously and assess whether guidelines for a particular diagnosis or medication dosage are appropriate for each particular patient and whether the patient history shows any sensitive conditions that would alter the physician's clinical assessments. finally, different options for granularity influence how identity theft may manifest, its corresponding implications on clinical care, and provider liability. first, if an hio excludes sensitive information from its hie then medical identity thieves may strategically target patients in this hie to obtain specific "sensitive" costly goods and services because they know that a record of their receipt of these services will not show up in the patient's file and the patient will not be alerted to the theft until months later when the patient is billed by insurance. as with other forms of medical identity theft, providers must bolster their data security to lessen the potential for general identity theft and 123 hoffman, supra note 1, at 1538-42; mangalmurti et al., supra note 120, at 2062, 2064. 70 vol. 10-1 granular control of ehrs increase point of contact identity matching during patient care interactions to minimize institutional liability. second, if an hio includes sensitive information providers must be aware of the possibility that information in the patient's chart relating to a sensitive condition may not reflect the patient's actual medical history. providers should take care to scan areas of patients' comprehensive emr and mention potential areas that influence their clinical decision-making to ensure patient's verbally recounted history accurately matches patient records as a precaution to minimize physician liability. viii. policy considerations and conclusion the complexities and disparities among state law treatment of sensitive information poses the challenging question of how to balance protecting patients' deeply private sensitive medical records while building hies that can increase the effectiveness of patient care. as policymakers and emerging hios consider options for granularity, they should consider whether the policy choice interferes with the overarching purpose of the hie. that is, a patient's ehr is designed as a comprehensive medical history reference so physicians can make a fully informed diagnosis, offer appropriate options for treatment, and check for contraindications or potential negative interactions. if an hio fully excludes sensitive information from its hie, physicians could miss crucial information relating to the patient's state of mind, whether the patient's decision-making capacity is influenced by external factors, or whether information in the patient's sensitive record would alter the physician's clinical judgment for diagnosis and appropriate treatment actions. privacy advocates warn of the embarrassment and stigma arising from disclosure of sensitive medical information and the risks of wrongful disclosures. these concerns should not be dismissed, but instead we should design a system that can tailor access to the information and release it when necessary. importantly, patients should understand both the risks and benefits of 2013 71 indiana health law review participating in the hie and why sequestering sensitive records from the hie can negatively effect their clinical care. as a policy objective, the hio should strive to educate patients on the benefits and risks of placing their information in the hie and design a system where physicians can access their comprehensive records with their knowledge and permission. operational models demonstrate that patients want to understand and choose whether to participate in the hie and assume the benefits and risks, which could be accomplished by consent or optout. an hio could limit access to the sensitive information with an added layer of security but still hold the sensitive information as a reference. if an hie contains sensitive information in masked and flagged form, physicians can initiate a conversation with patients about the information, request access when appropriate, and gain access in an emergency. this system would limit disclosures of sensitive information to respect patients' privacy while striving to facilitate trust and communication. patient privacy should not come at the expense of a physician's ability to accurately assess patient history and effectively treat the patient, which could cause the patient tangible and substantial physical harm. policymakers and hios should consider how choices for granularity affect the long-term goals of the hie, its ability to sustain patient trust, and serve as an effective resource for physicians to provide effective clinical care. despite the potential promises for advancing clinical care and using the hie data for research; hios must recognize that the ability to derive public health information is intricately tied to patient trust. using patients' health information without their knowledge or consent will undoubtedly result in patients' loss of the trust in the hio and their providers and accordingly, hios should not adopt policies that ignore or override patients' desires not to share their health information in the hie or for research. given this large amount of patient information in the hie, hios must also anticipate evolving risks of wrongful disclosure and potential for security breaches. hios should carefully communicate these risks to patients, and take steps to 72 vol. 10:1 2013 granular control of ehrs 73 mitigate wrongful disclosures and intentional breaches. finally, providers should consider how varying options for granularity could impact their ability to effectively treat patients by integrating medical history and clinical decision support features and consider future projections of potential provider liability. rethinking health app regulation: the case for centralized fda voluntary certification of unregulated non-device mobile health apps rethinking health app regulation: the case for centralized fda voluntary certification of unregulated non-device mobile health apps samuel j. dayton* i. introduction ........................... 714 a. introduction to the health app market ... ..... 717 b. current state of the health app market..............720 c. doctors' concerns regarding the current health app market .................................. 721 d. role of the fda in regulating health apps.........722 ii. legal background ............................. 722 a. scope of the draft guidance......... ........ 722 b. health apps not covered by the draft guidance.... 723 c federal preemption .................... 725 iii. certification of health apps explored ......... 726 a. the need for a certification process ............. 726 b. the happtique model. .............. ........... 727 c. a centralized certification scheme for direct fda certification ......................... ..... 731 1. voluntary nature of the program ..... ..... 735 2. cooperation with other agencies..... ..... 736 3. implementation of the certificates .... ..... 739 d. an alternative, decentralized certification scheme for the fda..........................739 1. current uses of decentralized certification programs...............................741 2. implementation of the decentralized certification program .............. ..... 742 3. potential dra whacks of the decentralized certification program ................... 745 iv. conclusion .................................... 748 * j.d., 2014, indiana university robert h. mckinney school of law, indianapolis, indiana; b.a., 2011, indiana university, bloomington, indiana. indiana health law review i. introduction young adults suffering from a persistent case of acne may try special creams, cleansing soaps, or changes in diet, but in 2011 some chose to try blue and red light emitted by their cellular phones. developers of software applications that purportedly relied on credible science led these consumers astray. with only the tap of a screen, these consumers would be on their way to brighter and clearer skin. unfortunately, these claims were too good to be true. in today's mobile industry, a library's worth of medical information is one tap of a screen away, and consumers without any particularized medical knowledge are left to fend for themselves. the federal government should allow developers of mobile software containing health information to petition for certification of their products. this would not only promote consumer confidence in the certified software but would help consumers avoid spending time and money on deceptive scientific claims. on october 13, 2011, the federal trade commission ("ftc") filed a complaint against koby brown and gregory w. pearson both individually and doing business as dermapps. 1 dermapps developed and marketed an app called "acneapp" that would use blue light to fight bacteria and red light to heal skin on acne-prone skin.2 in the app's description, dermapps referenced a study by the british journal of dermatology to show blue and red light treatments eliminated p-acne bacteria, allegedly a major cause of acne, and would reduce skin blemishes by as much as 76%.3 however, dermapps misrepresented the british journal of dermatology study because the study did not prove that blue and red light as provided by acneapp would be an effective treatment for acne, so dermapps acted deceptively or unfairly by making a false advertisement in violation of the federal trade commission act. 4 by the 1 complaint at *4, in re koby brown, (no. c-4337), 2011 wl 5228729 (f.t.c. oct. 13, 2011); 15 u.s.c. §§ 45(a), 52 (2013). 2 id. 3 id. 4 id. 714 vol. 11:2 rethinking health app regulation time that the ftc filed its complaint a year and a half later, the app had been purchased for $1.99 approximately 11,600 times.5 the commission voted unanimously to accept a settlement agreement with dermapps that contained, among other things, a fine of $14,294.6 acneapp was a special type of software application that was intended, or at least appeared to intend, to cure a medical condition, but there are many other types of healthrelated apps available for purchase. today, health apps purport to provide easy solutions for everything from "flabby abs to alcoholism," and they promise to provide relief from symptoms such as pain, stress, stuttering and ringing in the ears. 7 many of these apps fail to follow established medical guidelines, and few are tested through the sort of clinical research used for treatments sold by other means.8 around 247,000,000 smartphone users are expected to have downloaded health apps in 2012.9 some health apps, such as "lose it" as used for weight loss, "azumio" as used for measuring heart rates, and "itriage" as used to check symptoms and search the local area for hospitals with the shortest wait times, appear to be quite good.10 however, consumers tend to have to rely upon descriptions written by an app's developers or the anonymous, mixed reviews." apps are generally sold through third parties. apple and google are two of the largest. the amount of protection they offer to consumers is unclear because both have been hesitant 5 id. at 1-2; 'acne cure" mobile app marketers will drop baseless claims under ftc settlements, fed. trade comm'n (sept. 8, 2011), www.ftc.gov/opa/2011/09/acnecure.shtm, archived at http://perma.cc/5gyl-j5sj. 6 id.; agreement containing consent order, fed. trade comm'n, http://www.ftc.gov/os/caselist/1023205/110908dermappsorder.pdf, archived at http://perma.ccldaf7-74vd. 7 rochelle sharpe, lacking regulation, many medical apps questionable at best, ctr. for new england investigative reporting (nov. 18, 2012), http://necir-bu.org/investigations/medicalapps, archived at http://perma.ccldb8h-k6wa. 8 id. 9 id. 10 id. 11 id. 2014 715 indiana health law review to make statements about their apps, processes, and rules for developers. 12 apple indicated to the federal communications commission ("fcc") that apps will be rejected if they fail to operate correctly on a technical level, contain malicious "bugs" that may damage users' devices, or fail to perform as advertised. 13 apple also stated that it aims to protect consumers' privacy and children from "inappropriate content."14 google's content guidelines seem to indicate that it only bans apps that are sexually explicit, gratuitously violent, or contain anything that may damage a user's device.' 5 sixty-six percent of global consumers use the advice of experts to influence their purchasing habits.' 6 on a global survey, the advice of experts was less influential to people than the advice of family and friends, but it was more influential to consumers than advertisements on the television and more than fifteen other methods for raising consumer awareness of a product. 17 this implies that the food and drug administration would most likely be able to influence consumers through a certification program, which would 12 id. 13 id.; apple answers fcc questions, apple, http://www.apple.com/hotnews/apple-answers-fcc-questions (last visited may 21, 2014), archived at http://perma.ccldej5-75vb. 14 apple answers fcc questions, supra note 13. note that apple, as early as 2009, received 8500 app submission each week and usually rejected 5% of them. id. by extension, apple likely rejected as many as 22,100 apps in 2009. apple does not appear to have provided more recent data on submission statistics, but it did approve its one-millionth app in 2012, and in january 2014, apple announced that customers spent over $10 billion in its app store. see seth fiegerman, apple has approved 1 million apps for the app store, mashable (nov. 19, 2012), http://mashable.com/2012/11/19/apple-app-store1-million-submissions, archived at http://perma.cc/zm2n-f76b; press release, app store sales top $10 billion in 2013 (jan. 7, 2014), available at http://www.apple.com/pr/library/2014/01/07app-store-sales-top-10billion-in-2013.html, archived at http://perma.cc/4em-9cfr. 15 sharpe, supra note 7. 16 every breakthrough product needs an audience: find yours in all corners of the world, nielsen 14 (jan. 2013), http://www.nielsen.com/ content/dam/corporate/us/en/reports-downloads/2013%20reports/nielsenglobal-new-products-report-jan-2013.pdf, archived at http://perma.cc/ yc5s-2mx9. 17 id. 716 vol. 11:2 rethinking health app regulation signal to consumers which health apps had met an established set of protective criteria. developers of health-related mobile applications should also take notice that endorsements from the fda, with its vast experience with health and safety, would likely have a positive impact on economic growth when compared to health apps lacking the fda's certificate. a. introduction to the health app market technological achievements have made rapid changes in individual healthcare mobile applications. today, a consumer may download applications onto his or her mobile device (e.g., cell phone or tablet computer) that address almost any facet of healthcare. the realm of mobile technology is complex, and its relevant vocabulary is intricately defined. the software programs consumers use on their mobile devices are called "apps." 18 apps are "software application[s] that can be executed (run) on a mobile platform . . . or a web-based software application that is tailored to a mobile platform but is executed on a server."19 in fact, apps are responsible for as much as 56% of all activity on at least android smartphones. 20 they are a major, if not the primary, source of interaction consumers have with their mobile devices. mobile platforms are "commercial off-the-shelf (cots) computing platforms, with or without wireless connectivity, that are handheld in nature."21 these include include iphones, blackberry phones, android phones, tablet computers, or other smart phone or digital personal assistant devices. 18 food and drug admin., mobile medical applications: draft guidance for industry and food and drug administration staff 1, 7 (july 21, 2011) [hereinafter draft guidance], available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandgui dance/guidancedocuments/ucm263366.pdf, archived at http://perma. cc/rwn6-jq4a. 19 id. 20 you have an app for that ... now what, nielsen (june 22, 2011), http://www.nielsen.com/us/en/newswire/20 11/you-have-an-appfor-that-now-what.html, archived at http://perma.cc/z26s-9hhw. 21 draft guidance, supra note 18, at 7. 2014 717 indiana health law review there are many brands of mobile devices, and each operates slightly differently. "ios" devices are products designed, developed, and manufactured by apple, inc., and include iphones, ipads, and ipods. 22 the mobile platform for these devices is called "ios."23 app developers for ios devices publish and sell their apps on apple's "app store."24 another major player in the mobile technology industry is android. android is an open-source software, or mobile platform, for mobile devices, in a project led by google. the project was created to ensure that no party could restrict or control the innovations of any other.25 other corporations, such as research in motion or microsoft, lie somewhere on the spectrum in-between apple and android. app developers have crafted mobile apps to address countless issues related to healthcare. some apps, such as those that measure glucose levels in the blood, render the app and mobile device a "medical 'device."' a medical device is an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . .. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals."26 any app that meets this definition and is either "used as an accessory to a regulated medical device" or "transforms a mobile platform into a regulated device" is a mobile medical app. 27 the food and drug administration looks to the "intended use" of a mobile app to determine whether it 22 apple ios software license agreement, apple, http://apple. com/legallsla/docslios6.pdf, archived at http://perma.cc/syk6-jpnk. 23 id. 24 there is some confusion about whether this is a generic title under u.s. trademark law. see generally apple, inc. v. amazon.com, inc., 2011 u.s. dist. lexis 72271 (n.d. cal. 2011). 25 open source project, http://source.android.com (last visited nov. 4, 2012), archived at http://perma.cc/8gcy-st4h. 26 federal food, drug, and cosmetic act, 21 u.s.c. § 321(h)(2) (2014). 27 draft guidance, supra note 18, at 7. 718 vol. 11:2 rethinking health app regulation counts as a "device."28 if the intended use of a mobile app is to diagnose, cure, treat, mitigate, or prevent a disease or other condition or is "intended to affect the structure or any function of the body of a man," the mobile app is a device. 29 the fda only regulates devices that meet the definition of a "device" under §321(h)(2). devices are organized into three categories. class i devices are those which represent the smallest risk to consumers, while class iii devices represent the greatest risk. some class i and most class ii devices require creators of those devices to inform the fda that the devices are safe, effective, and substantially equivalent to devices already marketed legally. 30 this is called premarket notification.31 in 2010, only 3% of smartphone owners used them solely for telephonic conversation.32 furthermore, as of 2010, even though only 21% of people who had wireless device subscriptions owned smartphones, 45% of the population without smartphones expressed that their next cellular device would be a smartphone.33 however, the growth in smartphone ownership has actually increased much faster. in 2012, twothirds of people buying new cell phones opted for smartphones. this means that the number of people exposed to and misled 28 draft guidance, supra note 18, at 7-8 (citing 21 c.f.r. § 801.4 (2014) (stating that intended use may be shown through labeling claims, advertising materials, or oral or written statements made by manufacturers)). 29 draft guidance, supra note 18, at 7-8. 30 premarket notification (510k), food and drug admin. (sept. 3, 2010), http://www.fda.gov/medicaldevices/ deviceregulationandguidance/howtomarketyourdevice/premarketsub missions/premarketnotification5lok/default.htm (citing 21 c.f.r. § 807.92(a)(3)), archived at http://perma.cc/9bmw-vr9r. 31 bradley merrill thompson, fda regulation of mobile health, mobihealthnews 6 (june 2010), http://mobihealthnews.com/wpcontent/pdflfdaregulation of mobilehealth.pdf, archived at http://perma.cc/zuj8-63z5. 32 roger entner, smartphones to overtake feature phones in us by 2011, nielsen (mar. 26, 2010), http://www.nielsen.com/us/en/ newswire/2010/smartphones-to-overtake-feature-phones-in-u-s-by-2011. html, archivedathttp://perma.cc/xc7z-w6gp. 3 3 id. 2014 719 indiana health law review into purchasing deceptive, faulty, useless, or inaccurate health apps will only increase as time goes on. b. current state of the health app market some health apps were designed to serve as medical devices, but there are many other sorts of health apps. there even seems to be a greater use of apps that are not medical devices. 34 consumers can download apps that track their fitness, wellness, exercise, and diet.35 fitness and wellness apps can easily be sold to people who are fairly healthy already and just want to stay fit, and hospital administrators realize that these apps can be used for chronic disease management and may keep people out of the hospital.36 the health app market is moving in a direction where a person with asthma would open an app and determine whether his or her asthma symptoms will be worse on a given day based on the pollen count.37 or a person with a heart condition might open an app and receive feedback on inconsistencies of that person's heartbeat. most health apps are "technically reliable in that they work, but their accuracy is largely dependent on where they source their background data from." 38 interestingly, twothirds of people who use health and fitness apps stop using them after six months or less. 39 perhaps this is due to consumer apathy, but it may also be an indicator of the underlying quality of the apps. consumers do anticipate and 34 ken terry, more consumers get health info on mobile devices, info.week (oct. 8, 2012), http://www.informationweek.com/healthcare/ patient/more-consumers-get-health-info-on-mobile/240008624#, archived at http://perma.cc/t5jf-w2nm. 35 id. 36 id. 37~ id. 38 merry christmas and app-y' new year, nat'l health serv. (dec. 23, 2010), www.nhs.uk/news/2010/12december/pages/health-appguide-iphone.aspx, archived at http://perma.cc/4zs6-8ype. 39 ryan faas, why your doctor doesn't want you using iphone and ipad health apps, cult of mac (june 20, 2012, 7:43 am), http://www. cultofmac.com/174776/why-your-doctor-doesnt-want-you-using-iphoneand-ipad-health-apps/, archivedathttp://perma.ccl9ymu-mguu. 720 vol. 11:2 rethinking health app regulation expect big changes in their futures from mobile health apps. in one study, 48% of respondents said they expected mobile health apps would change the way they manage chronic conditions, 48% said mobile health apps would change the way they manage their medications, and 49% said mobile health apps would change the way they manage their overall health.40 c. doctors' concerns regarding the current health app market the reaction of doctors to the explosive growth of the health app field seems to be mixed. doctors do not appear to be fully aware of all of the available health apps in the market. furthermore, medical professionals are unlikely to risk their medical licenses and trust health apps for their patients unless a respectable party like the fda has confirmed value and accuracy of the apps. 41 less than two-thirds of healthcare providers acknowledge that mobile technology offers potential benefits for patients, but they feel that mobile health is unexplored and untested territory. 42 approximately 73% of doctors do not suggest mobile health apps to their patients and 13% actually discourage patients from using them.43 doctors' concerns about how patients would use their mobile health apps were a major factor in discouraging their use.4 4 these concerns included fears about how the patients would comply with their health apps, the lack of ability for the physicians to ensure the app's proper use, and that patients might become "too independent and avoid regular office visits." 45 the concern about consumer independence "appears to be a very valid point since 59% of mobile health users said ios apps and other mobile technologies have replaced some visits to doctors 40 id. 41 travis good, why doctors aren't prescribing health apps to patients, kevinmd.com (mar. 19, 2012), http://www.kevinmd.com/ blog/2012/03/doctors-prescribing-health-apps-patients.html, archived at http://perma.cc/s2er-6v55. 42 faas, supra note 39. 43 id. 44 id. 45 id. 2014 721 indiana health law review or nurses." 4 6 this suggests consumers may be or become vulnerable to deceptive health apps without correction from medical experts. physicians are currently also uncomfortable recommending health apps at the moment because of uncertainty about future regulation of the field.4 7 furthermore, medical apps potentially can pose risks to public health. these risks may even be unique to mobile platforms. 48 for example, "the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform."49 d. role of the fda in regulating health apps the current role the fda plays in regulating health apps is not completely clear. the fda is charged with promoting the science and innovation necessary to ensure that the united states is fully equipped to address the public health challenges of the modern world.50 it is the fda's job to ensure safety and efficacy in fda-regulated products as well as to work to foster scientific innovation leading to tomorrow's "new breakthrough products." 51 however, the fda has so far only issued draft guidance rather than a final decision regarding the regulation of mobile medical apps. ii. legal background a. scope of the draft guidance the fda's draft guidance for industry and food and drug administration staff mobile medical applications 46 id. 47 id. 48 draft guidance, supra note 18, at 6-7. 49 id. 50 margaret a. hamburg, fda and innovation: addressing the public health challenges of the 21st century, u.s. food and drug admin. (july 15, 2011), http://www.fda.gov/newsevents/speeches/ ucm275219.htm, archived at http://perma.cc/el7b-pkel. 51 id. vol. 11:2722 rethinking health app regulation illustrates the fda's current thought on the future of health app regulation. the guidance is meant to explain that the fda intends to apply its regulatory requirements to a certain subset of mobile apps. 52 this subset only includes mobile apps that meet the statutory definition of a device and either are used as an accessory to regulated medical devices or transform mobile platforms into regulated medical devices.5 3 the draft guidance does not address many different topics including wireless safety; classification and submission requirements related to clinical decision support software; or the application of quality systems to software. 54 the fda appears to intend to address these topics at a later time.55 b. health apps not covered by the draft guidance the fda has classified health apps into two categories: (1) regulated medical device health apps and (2) unregulated non-medical device health apps. the fda identifies the following as examples of health apps that would not be covered by its intended regulation: copies of medical textbooks, teaching aids, or reference materials; text solely for providing clinicians with training or reinforcing previous training; apps that log, record, track, evaluate, or make decisions or suggestion "related to developing or maintaining general health and wellness" that are not intended for "curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition;" apps that simply automate general office operations with functions including billing, inventory, appointments, or insurance transactions; apps that are "generic aids that assist users but are not commercially marketed for a specific medical indication;" and apps that 52 draft guidance, supra note 18, at 4. 53 id. at 12. 54 draft guidance, supra note 18, at 10-11. (these would also be beyond the scope of this note.) 55 id. 2014 723 indiana health law review "perform the functionality of an electronic health record system or personal health record system."56 textbooks, teaching aids, and reference materials could include flashcards, quizzes, slide shows with medical pictures or diagrams, and lists of medical terminology that are to be used primarily by medical students.57 these types of apps contain no patient-specific information, but they may contain specific examples for illustration.5 8 mobile apps that do take in patient-specific information and output patient-specific information using any of these sources of medical information, however, would be covered by the draft guidance.59 some apps log, record, track, evaluate, or make decisions or suggestions regarding general health and wellness maintenance but are not meant to cure, treat, mitigate, or diagnose a specific disease, disorder, patient state, or any specific, identifiable health condition. examples of these apps might include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that "generally relate to a healthy lifestyle and wellness." 60 these are examples given by the fda, but there does appear to be some tension with the patientspecific input and output element as previously described. apps with patient-specific input and output will likely have to be assessed on a case-by-case basis in the future. apps that simply automate general office operations might include the following: "apps that determine billing codes like icd-9 (international statistical classification of diseases); medical business accounting functions and aids that track and trend billable hours, procedures, and reminders for scheduled medical appointments . .. ; apps that automate functions such as collecting patient histories that replace paper-based entry; apps that enable insurance claims data collection and processing; and other apps that are similarly administrative in 56 id. at 16-18. 57 id. at 20. 58 id. at 21. 59 id. at 24. 60 id. 24-25. vol. 11:2724 rethinking health app regulation nature."61 these health apps perhaps have the least to do with the health of patients and are least likely to be used by individual consumers. apps that are generic aids might include apps that use the camera and screen of a mobile device to create a magnifying glass effect (but not specifically for medical purposes), recording audio, note taking, replaying audio with amplifications, and other similar functions. 62 the fda intends to monitor mobile apps that are outside this guidance and may determine whether additional or different actions are needed to protect the public health.63 manufacturers may choose to register and list their apps and to seek approval or clearance for them with the fda. 64 however, this process is a subtle verification of an app's permissibility in the marketplace, and seems more directed at cautious app developers than at uninformed consumers. the fda could and should do more to certify accuracy and trustworthiness of mobile health apps. this would promote consumer confidence in objectively trustworthy and accurate health apps and protect consumers from spending money on health apps that are neither trustworthy nor accurate. c federal preemption although states generally have jurisdiction over consumer protection issues, a certification program for health apps properly falls under federal jurisdiction, especially if it is extended to medical device apps. federal law explicitly preempts state law on medical device laws. 65 this likely means that mobile medical device apps fall 61 id. at 21. 62 id. at 21-22. 63 id. at 12. 64 id. at 32. 65 21 u.s.c. § 360(k) (2013) (prohibiting states from establishing or continuing in effect medical device regulations "different from, or in addition to, any requirement applicable under this chapter" and relates to the safety or effectiveness of the device except in very limited circumstances). 2014 725 indiana health law review under federal jurisdiction as well. 6 6 preemption is less clear for non-device apps. presumably, the creation of a certification process would raise preemption issues. iii. certification of health apps explored a. the need for a certification process certification is a process used with great success in other realms of modern technology. the establishment of "certification authorities" plays a vital role for commerce, meeting the demands of ever-changing technology, a transition to a paperless society, and the integrity of cyberspace.6 7 these certification authorities are critically important at the level of cybernotarization and authentication within international e-commerce. 68 in that contest, trusted third parties act as notaries, 69 but that is only one approach to certification. given the explosive growth in health apps, it would be impossible for the fda to evaluate the claims of every single health app available to consumers. indeed, imagining the fda attempting to carry out such a task evokes a comparison to lucy ricardo having to stuff pieces of chocolate in her mouth and clothing as she fails to keep up with the speedy assembly line.7 0 currently, the federal government appears to take a caveat emptor approach to ex ante consumer protection. 7 buyer beware! this approach is insufficient. 6 draft guidance, supra note 18, at 8 (stating that apps that are intended to work like medical devices are regulated as medical devices). 67 dina athanasopoulos-arvanitakis & marilynn j. doe, a proposed code of professional responsibility for certilcation authorities, 17 j. marshail j. computer & info. l. 1003, 1004-05 (1999). 68 id. at 1003, 1003 n.1. 69 id. at 1004. 70 i love lucy.' lucy goes to work (cbs television broadcast sept. 15, 1952), available at http://www.tvland.com/video-cips/t9jwdz/i-lovelucy-lucy-goes-to-work. 71 see generally miracle health claims, fed. trade comm'n (nov. 2011), http://www.consumer.ftc.gov/articles/0167-miracle-health-claims (stating that fraud in health-related claims is a problem so that is why it is "important to learn how to evaluate claims for products related to your health"), archived at http://perma.cc/3fef-c2d7. 726 vol. 11:2 rethinking health app regulation reliance on health apps that have not been based on established medical practices and tested by professional peer review, like traditional medical treatment, leaves consumers who are, "at best, delaying appropriate treatment, and, at worst, threatening their health."72 consumers would be better served by a voluntary system that requires app developers to seek out the fda for heightened credibility. b. the happtique modep3 happtique, a recent startup and subsidiary of the greater new york hospital association, is set to become the 72 patrick a. malone, want bad health advice? there's an app for that, patrick malone & associates, p.c., dc medical malpractice & patient safety blog (nov. 26, 2012), http://www.protectpatientsblog.com/2012/11/want bad health advice t heres_1.html, archived at http://perma.cc/gtu8-ux3j. 73 around the time this note was submitted to indiana health law review, happtique experienced a major setback. harold smith, iii, randomly tested two apps that happtique certified as secure and found significant security risks. brian dolan, happtique suspends mobile health app certification, mobihealthnews (dec. 13, 2013), http://mobihealthnews.com/28165/happtique-suspendsmobile-health-app-certification-program/, archived at http://perma.cc/r6qc-3ua6. since then, happtique redesigned its website and removed many of the sources cited below. by the time happtique suspended its certification operations, it had not experienced much success. satish misra, m.d., took happtique's security oversight as evidence of flaws in app certification as a whole. satish misra, happtique's recent setback shows that health app certification is a flawed proposition, imedicalapps (jan. 8, 2014), http://www.imedicalapps.com/2014/01/ happtiquessetback-future-app-certification/, archived at http://perma.cc/d924vc8e. misra is correct that certification is a one-size-fits-all proposition and that certification cannot tell an individual customer about whether an app will be what he or she needs. id. however, the certification models proposed in this note are not intended to act as surrogate physicians; for diagnoses or specific treatment methods, see a physician. however, certification can protect consumers in determining whether an app is and does what the developer says it is and does. although many of the sources below are no longer available, this section was included to serve as an introduction to the concept of certification and not as a recommended model. since there do not appear to be any other similar organizations that could substitute for happtique in this section, the happtique section remains a part of this note. 2014 727 indiana health law review country's first organization to certify specifically healthrelated apps for safety and effectiveness. 7 4 it intends to provide consumers with a way to "identify [health] apps that meet high operability, privacy, and security standards and [that] are based on reliable content."75 happtique's certification standards, like the fda guidance on mobile medical device apps, remains in a draft state only as of the publication of this note.76 the draft stage of happtique's standards still provides useful guidance for steps the fda might take. before certifying apps, happtique has indicated it intends to review apps for operability, privacy, security, and content. 77 this note mainly focuses on content of apps, but operability, privacy, and security are important as well, and any certification program adopted by the fda should contemplate them in some way. under happtique's certification standards, an app must be "based on one or more credible information sources such as an accepted protocol, published guidelines, evidencebased practice, peer-reviewed journal, etc."78 developers must submit documentation about the information source if the source is a public or private entity.79 if the source of the information within the app comes from any other source, the developer must submit information about how the content in the app was derived, its relevancy, and its 74 sharpe, supra note 7; happtique (2011), http://www.happtique.com (last visited jan. 11, 2013), archived at http://perma.cc/6xz9-wxb5. (disclaimer: please note that this note is not endorsing happtique's services or certification of apps, and the author of this note is not affiliated with happtique in any way). 75 app certification, happtique, http://www.happtique.com (last visited jan. 11, 2013) (last change in original). 7 6 id. 77 see generally happtique app certification program: draft app certification standards, happtique, http://www.happtique.com/wpcontent/uploads/appcertification-standards-final.pdf (citing generally mededportal submission standards, the association of american medical colleges (nov. 3, 2011), http:/www.mededportal.org/download/ 262700/data/mepsubmissionstandards.pdf). 78 happtique app certification program: draft app certification standards, happtique 11, http://www.happtique.com/wpcontent/uploads/app-certification-standards-final.pdf. 7 id. 728 vol. 11:2 rethinking health app regulation reliability.80 happtique also requires that any deviations from the content of third parties the app contains be indicated and explained, and the app must provide a citation to the third party content in its entirety for the consumer.8 ' furthermore, all apps must draw on content from at least one authoritative work that is recognized within the field or discipline of the app and, as appropriate, is derived from published and/or peer reviewed work. 82 any instructional, educational assessment, and other apps of a similar kind, specifically, must derive its content from "accepted pedagogy and/or learning strategies or techniques that are appropriate for the intended audience(s)." 83 therefore the app must rely upon authoritative sources that have been recognized within the field or discipline that is the subject of the app and, as appropriate, come from published or peer reviewed works, or both. 84 these apps must have clearly stated learning objectives, and the methods for teaching and/or learning must be suitable to meet those objectives. there must also be a process or method for assessing and documenting improvements in knowledge or skill.85 developers must also ensure that all of the app's content contains information that is current as of the date the app is submitted for certification. 86 app developers must demonstrate and explain why the information contained within the app is current and that the developer has a method or protocol for keeping the app's content current for the entire time the app is certified by happtique. 87 apps need to be updated to keep their information content up-todate and for other software-related reasons. happtique has not yet released its standards and requirements for recertification of apps except that all updates must include 80 id. 81 id. at 12. 82 id. at 13. 83 id. 84 id. 85 id. 86 id. at 11. 87 id. 7292014 indiana health law review descriptions and documentations of each change to the app.88 all apps must comport with all applicable laws, rules, and consumer protection regulations dealing with advertising claims, marketing, promotional activities, and sales practices. 89 generally, this means that the app's description and content must be truthful, fair, and not misleading, backup documentation to substantiate claims made in the description or content is available, and clear and conspicuous disclosures are provided to prevent deception.9o electronic health record systems for mobile devices have to be designated for certified electronic health records that have already been certified by an appropriate authorized testing and certification body. 91 if an app contains any of the following including, but not limited to, mathematical formulae, calculations, data tracking, reminders, timers, measurements, or other related operations, the app does so with "sufficient accuracy and reliability" to achieve the operation's intended purpose. 9 2 that means not only must the app perform satisfactorily on a technical level, the operations that incorporate content must also perform satisfactorily. apps with multiple purposes or functions must ensure each element comports with happtique's requirements under any relevant standards.93 the guidelines require that advertisements within apps are clearly designated as such. 94 any such advertisement may not violate fda, ftc, or fcc laws or regulations governing advertisements and claims made therein. 95 developers must take care to ensure that the app specifically designates any claim that could be construed as medical advice for treatment recommendations is meant 88 id. at 11 n.13. 89 id. at 12-13. 90 id. at 12. 91 id. at 14. 92 id. at 12. 93 id. at 15. 94 id. 95 id. 730 vol. 11:2 rethinking health app regulation solely for advertising and not for other purposes; it must also state that the advertising claim should not be considered a substitute for medical or clinical advice.96 in no case may an app contain advertising supported through products containing malicious code or software such as spyware, viruses, or any other malicious software. 97 lastly, any app the developer intends to be used primarily by laypersons must be written and presented in such a way that is "appropriate for the intended audience." 98 this means that anybody using an app primarily intended for laypersons must be able to readily understand the content of the app, and technical terminology must be used only as appropriate to meet these ends. 99 happtique, and any other future private certification body, would not become moot by the presence of a voluntary certification model where the fda certifies health apps directly. app developers could choose happtique over the fda certification process. happtique may make a strategic decision to require less of apps than the fda to attract the developers who do not wish to meet the fda's exacting standards, but consumers would likely notice the fda's absence. happtique, then, could become a more prestigious brand. if happtique raises its standards above those of the fda, then consumers may come to trust that a happtiquecertified app is a safe choice. c a centralized certification scheme for direct fda certification the ftc settlement with acneapp makes a convenient example for how the fda might formulate its certification program. this is because although acneapp was a mobile medical device app and would therefore be regulated under the forthcoming fda regulations as indicated by the draft guidance, it did not contain the same level of threat of harm 9 6 id. 9 id. 9 8 id. 9 id. 7312014 indiana health law review to consumers as most regulated medical devices. acneapp purportedly cured acne when the mobile device was held against the affected area. there is a possibility that holding a wireless device up to a person's face could increase his or her chance of developing cancer, 100 but even so this exposure would be for two minutes on each of the blue and red lights, each of which was only slightly longer than the average call on a cell phone in 2011.101 this suggests any physical damage to consumers was minimal, so the harm faced by consumers was likely the pecuniary cost of purchasing the app. as a result, the ftc's treatment of dermapps provides useful guidance for an fda centralized certification model for non-device apps, where the damage would be most likely to be pecuniary with a more remote possibility of physical harm. the happtique model is rather exhaustive and may help consumers somewhat, but the fda could go further in its protection of consumers. the ftc already demands more when it reaches settlements with app developers for false advertisement claims, unfair or deceptive acts or practices charges, or violations of the federal trade commission act. 102 when dermapps settled with the ftc over the claims it made in and about acneapp, the ftc demanded that if dermapps engage in marketing acneapp in the future it first meet certain standards. if the app made any claims about acneapp's ability to treat acne, it would need to ensure its claims would be "non-misleading" by possessing the following: 100 iarc classifies radiofrequency electromagnetic fields as possibly carcinogenic to humans, int'l agency for res. on cancer, world health org. 1-2 (may 31, 2011), http://www.iare.fr/en/mediacentre/pr/2011/pdfs/pr2o8_e.pdf, archived at http://perma.cc/ed7w6dbg. 101 will dean, will dean ' ideas factory; tracking phone call lengths, the independent (june 7, 2012), http://www.independent.co.uk/lifestyle/gadgets-and-techlfeatures/will-deans-ideas-factory-tracking-phone-calllengths-7821172.html (reporting that the average length of calls on mobile devices was down to 1.78 minutes), archivedathttp://perma.cc/33eq-m75x. 102 complaint at *4, in re brown, 2011 wl 5228729 (f.t.c. oct. 13, 2011); 15 u.s.c. §§ 45(a), 52 (2013). 732 vol. 11:2 rethinking health app regulation two adequate and well-controlled human clinical studies of the device, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true. 0 3 happtique's requirements contain a similar standard, but it only requires one study instead of two. the second independent study requirement helps ensure that the future science on which dermapps relies is valid and not fraudulently obtained. in addition to requiring more than one study to make claims, the ftc required that any representations made by dermapps be made with sufficient quality and quantity. 04 at first, this mandate may seem superfluous, but it actually means that two studies will not be enough to substantiate representations if they depend on fringe science. in order to make future representations, dermapps would have to actually rely on standards "generally accepted in . . . relevant scientific fields."105 this requirement may be more punitive than the fda might need to require for its voluntary certification program. however, the fda should at least require that an app relying on non-mainstream science conspicuously note it has done so. it should come as no surprise that the ftc also required dermapps not make representations based on evidence not in existence.106 this would be an obvious addition to any certification standards promulgated by the fda. any developer who submits fraudulent evidence it knows to be false or evidence on which it did not actually rely should be penalized criminally or civilly, or both. 103 agreement containing consent order at *4, in re brown, 2011 wl 4092215, (f.t.c. sept. 8, 2011). 104 id. at 5. 105 id. 106 id. at 4. 2014 733 indiana health law review dermapps also had to pay fines of $14,294.107 this requirement does not completely translate to an ex ante certification program because the ftc assessed the fines for an ex post violation. the fda could achieve a similar effect by giving a private cause of action for customers against developers who fraudulently obtain a certificate. the fda might also have to ensure that these cases may be brought as a class since the purchase price of individual apps is typically low, although the injuries from reliance on the apps could potentially be high. for example, if a free health app says consumers with lumps on their body need not see a doctor, consumers who rely on that advice would have a cause of action against the developer for medical costs or loss associated with that reliance. this could be a significant disincentive for developers to enter into the certification program. as such, developers who participate in the fda's centralized certification program in good faith would receive at least qualified tort immunity. the extent of this immunity is beyond the scope of this note, but it is likely necessary for significant participation in such a scheme. app developers would also have to keep the fda informed about any developments in the field of medicine or health that undermine the foundation upon which the developer originally secured certification. without this condition, consumers may over-rely on the fda's certificate. furthermore, it is much more efficient for the app developers to monitor the science behind their own apps than for the fda to monitor the science underlying all certified apps and verifying the certifications' continued legitimacy. perhaps certificates could expire annually and be renewed only if the developers affirm that the apps rely on no new evidence and the underlying science has not changed in such a way as to undermine the integrity of the apps' claims. also, any updates to the substantive components of the apps would need to either undergo a new review or an abbreviated application process. the specifics of this 107 id. at 5. vol. 11:2734 rethinking health app regulation update process are beyond the scope of this note, but at the very least, developers should be allowed to continue using the certificate during the review of the update. 1. voluntary nature of the program an fda certification would be completely voluntary to app developers. the only occasion where a developer could not participate and be punished for having not done so would be if the developer used the seal of certification without having obtained proper authorization and certification. a filing fee would help offset the costs of the certification program while discouraging frivolous applications. the voluntary nature of this program mixed with a filing fee means that the only influx of demands on the fda would be from developers who believe they and their consumers would benefit from an fda certificate on their app. the fda's filing fees, however, may have to be on a sliding scale to be based on the size of the app. an app full of reference material would likely require more fda resources to be certified than an app that calculates body mass index. voluntary certification programs are not unprecedented in the fda, but existing programs appear to be used for indirect consumer protection rather than for direct signals to consumers. for example, 15% of the food supply for the united states is imported and congress has passed new legislation to promote food safety.108 part of this effort was the creation of a voluntary certification program to provide expedited review to qualifying suppliers and their products. 109 the model proposed by congress has one more accreditation step than the decentralized certification method described below.110 this model may not be the most 108 susan a. schneider, notes on food law an overview of the food safety modernization act, 2011 ark. l. notes 39, 44 (2011). 109 id. at 45; see also 21 u.s.c. §§ 384b, 384d (2014). no 21 u.s.c. § 384d(b)(1)(a) (2014) (instructing the secretary of the department of health and human services to establish and accreditation body to accredit third party certifying entities or defaulting); see also discussion infra part iii.d. 2014 735 indiana health law review efficient way to implement a voluntary certification program for health apps, but it does signify that congress and the department of health and human services have previously demonstrated a willingness to explore certification alternatives, or at least supplements, to regulation. in fact, if the secretary of the department of health and human services failed to establish an accreditation body for the accreditation of third party certifying entities, the department could accredit the third parties itself; this would be strikingly close to the decentralized model discussed below."' 2. cooperation with other agencies a certification program of non-medical device medical apps, whether it is centralized or decentralized, may require the cooperation of the ftc and maybe the fcc. these agencies have a history of working together and share an interest in ensuring consumers can trust their health apps. an ex ante certification program may even reduce the number of necessary ex post investigations of healthrelated, non-medical device apps. the ftc is the agency usually tasked with protecting consumers from deceptive trade practices, but the specialized nature of health apps leave substantial room for the fda, which has the most and best resources to analyze health-related assertions. the ftc has a general mandate to keep an eye out for unfair or deceptive acts or practices as well as false or misleading claims." 112 this mandate includes looking for acts or claims that cause or are likely to cause substantial harm to consumers that cannot be avoided or be offset by benefits to consumers or 111 21 u.s.c. § 384d(b)(1)(a)(ii) (2014); see also discussion infra part iii.d. 112 brian dolan, how fda and ftc co-regulate health apps, mobihealthnews (mar. 22, 2012), http://mobihealthnews.com/16729/ how-fda-and-ftc-co-regulate-health-apps, archived at http://perma.cc/zve6-4bm3. incidentally, this app would also likely be considered a medical device and be directly subject to the jurisdiction of the fda. see 21 u.s.c. § 321(h)(2) (2013); draft guidance, supra note 18, at 7. vol. 11:2736 rethinking health app regulation competition. 113 the ftc has previously investigated mobile health apps. for example, as seen in the introduction of this note, the ftc pursued a case against the marketers of an app that purported to cure acne if a person held the device close to his or her face; the light from the device, allegedly, would cure the acne. 114 the ftc believed these claims were unfounded and pursued judicial action.115 the fda has a role in a certification program of health apps because, even though the ftc clearly has competency to investigate health-related claims, an ex ante certification program would involve investigating all potential problems with a health app rather than investigating specific deceptive claims. the ftc takes action when no "direct harm" is posed to consumers by the medical apps, and in those cases, the fda may choose to have the ftc take action or choose to take action itself.116 the fda and ftc do try to work together to minimize confusion that may arise from overlapping jurisdictions.117 furthermore, even though the ftc has jurisdiction "for health breaches when the entities involved are not health insurance portability and accountability act 11s covered entities," the ftc "carefully [determines] how best to work with [health and human services] on health information breaches." 19 additionally, the fcc and the fda have announced a joint statement of principles and have signed a memorandum of understanding signifying a heightened level of previous and future cooperation. it states the agencies' intentions to enhance efforts to "share information, improve the efficiency of our regulatory processes, promote efficient use of tools for product analysis and risk identification, and build infrastructure and processes that meet common needs for evaluating the safety and efficacy of broadband and wireless enabled medical 113 dolan, supra note 112. 114 id. 115 id. 116 id. 117 id. 118 pub. l. no. 104-191, 110 stat. 1936 (1996). 119 dolan, supra note 112. 2014 737 indiana health law review devices." 120 the ultimate goal of this partnership is "a balanced approach . . . [and] an approach that meets the unique challenges of the 21st century while prioritizing health and well-being above all else."121 the fda has an ongoing working relationship with both the ftc and fcc, so it is likely that the agencies could successfully cooperate in carrying out a successful certification program for health apps. the ex ante use of the fda's medical expertise, the ftc's expertise in consumer fraud, and the fcc's communications expertise not only would promote consumer confidence in health apps that have been certified and prevent apps that could not be certified from being produced. a centralized certification process would possibly have to include the cooperation of the ftc, fcc, or both. each agency would have personnel who would review the voluntarily submitted app within the respective agency's field of expertise and authority. given the fda's vast experience in the field of medicine, it should be the agency responsible for reviewing the accuracy and trustworthiness of the medical information within the health app. any reviewing member of these agencies would have the ability to reject the certification of health apps for nonarbitrary determinations that the app developer failed to meet that agency's standards of accuracy and trustworthiness. for example, dermapps would not have received approval from the fda for making false medical claims, and it would not have received ftc approval because it sought to induce purchases with false claims. given that acneapp had no communicative components, it probably would not have fallen under fcc jurisdiction. 120 margaret a. hamburg, comm'r of food and drugs, remarks at the fda/fcc public workshop: enabling the convergence of communications and medical systems, available at http://www.fda.gov/newsevents/speeches/ucm220447.htm, archived at http://perma.cc/6368-b8dn. 121 id. 738 vol. 11:2 rethinking health app regulation 3. implementation of the certificates apple, at least, has the ability to incorporate certificates into its app store. the ios software "contains functionality that allows it to accept digital certificates either issued from apple or from third parties."122 the definition of digital certificates is rather technical and requires acquaintance with upper-level mathematics, but it suffices to say that apple could cooperate with the fda to implement digitally verifiable certificates. 12 3 anyone who uses the fda's health app certificate without authorization would be subject to civil or criminal penalties, or both. for extra consumer protection, these penalties could extend to any entity that derives a benefit from the use of the certificate and plays a role in its unauthorized use. for example, if apple approved an app using an unauthorized certificate in its advertising, marketed it, and took a commission on the sale, it would face penalties. however, to protect apple in a situation like this, there should be a public registry maintained by the fda of apps that have been certified, so apple would only be liable in cases of its own negligence. d. an alternative, decentralized certification scheme for the fda cost constraints faced by the fda and other agencies or the desire to protect fledgling organizations like happtique may mean that a centralized certification program is not possible. if so, a decentralized certification program would still be possible. under such an approach, the fda would certify independent organizations like happtique rather than certify individual apps. these certified third parties would then turn around and certify the apps themselves. a decentralized certification process, as a concept, would not 122 apple ios 6 software license agreement, supra note 22, at § 9. 123 see description of digital certificates, microsoft corp. (jan. 23, 2007), http://support.microsoft.com/kb/195724, archived at http://perma.cc/6njh-3fxw. 2014 739 indiana health law review be revolutionary. it would be an evolutionary concept applied to the exploding mobile health market. independent organizations would need to demonstrate particular qualities to the fda in order to be certified. first, they would need to show that experts within the field of health and medicine would review the substantive content of the apps for accuracy, trustworthiness, reliability, and quality. the apps should also be reviewed by technological experts with respect to how the technological components of the apps bear on the reliability of the health-related components of the apps. for example, technical experts would ensure that an app that reminds consumers to take pills at particular times would be sufficiently reliable. whereas, if the app had a library of images to correspond with the pills the app is reminding the patient to take, pharmaceutical experts would need to verify the accuracy of these matches. the analysis factors used by the fda will vary greatly based on which approach the entity takes. a centralized approach means the fda uses standards to evaluate the content of the apps themselves, but a decentralized approach means the analysis must cast a wider net. any decentralized program requires an analysis to be both flexible enough to cover the limitless array of apps the third party certifying entities may be asked to review but also strict enough to provide effective protection to consumers post-review. it is a much more difficult standard to articulate and, if this approach is taken, the fda should take special care to receive input from developers, certifying third parties, and consumers to help it strike an appropriate balance. furthermore, as a result of these difficulties, there are really no previous examples directly on point, and any comparison will have limited application to health apps. this note endorses the centralized method over the decentralized one, but described below are past experiences the united states government has had with decentralized certifying and accrediting bodies that help shed light on concerns that a decentralized program for health apps would need to address. vol. 11:2740 rethinking health app regulation 1. current uses of decentralized certification programs a decentralized certification program would not be a revolutionary concept because it already exists in numerous forms within the united states government. third parties have been used in areas as diverse as education, nuclear regulation, and clinical trials with human testing.124 third party certification is widely used in the field of education. disbursement of federal funds has been tied to third party certifications from as far back as the early g.i. bills.125 as far back as a century ago, colleges sought to cooperate by adjusting admissions standards to achieve "uniformity in preparation" of their students. 126 there also were concerns about what a college education actually entailed. 127 these concerns, at least in part, ultimately resulted in accreditation of colleges by 1913.128 now, six regional accreditation bodies accredit thousands of higher education institutions.12 9 the modern approach to accreditation of educational institutions operates slightly differently from how certification of health apps would. these days, accreditation of higher education institutions is less about achieving uniformity and more about institutions achieving recognition from peers that they have lived up to their 124 see generally charles j. walsh & alissa pyrich, rationalizing the regulation of prescription drugs and medical devices: perspectives on private certification and tort reform, 48 rutgers l. rev. 883, 97387 (1996). 125 veterans' readjustment assistance act of 1952, pub. l. no. 82550, § 253(a)(1), 66 stat. 663, 675 (repealed 1958) (tying financial aid for veterans to courses offered by colleges or other institutions that had been "accredited and approved by a nationally recognized accrediting agency or association"), cited in walsh & pyrich, supra note 124, at 981. 126 douglas c. michael, federal agency use of audited selfregulation as a regulatory technique, 47 admin. l. rev. 171, 228 (1995) (citing william k. selden, accreditation: a struggle over standards in higher education 30-31 (1960)). 127 id. 128 id. 129 kenneth e. young et al., understanding accreditation 2628 (1983) (discussing the nature and membership of the six regional accreditation bodies), cited in michael, supra note 126, at 228. 2014 741 indiana health law review established goals. 130 this was actually a return to educational values that predated the history of accreditation; higher education institutions in the united states have a long history of diversity and local control over academic programs. 131 health apps are generally the same in one region of the country as they are in others, and therefore the historical tradition of regional diversity and control is not exactly relevant to health apps. but the use of accrediting bodies to ensure standardization is acutely relevant to certification of health apps since ensuring that health apps comply with demonstrated medical knowledge and proven scientific discoveries is the goal of such certification. the adaptability of third party certification programs suggests it may also have a place in protecting consumers from spending money on or placing trust in poor quality health apps. it is also a form of governance to which americans have become accustomed over the past century. 2. implementation of the decentralized certiflcation program national experiments with third party certification programs have had mixed success, and a decentralized certification program for health apps should learn from those successes and failures. in 1952, congress adopted, and the commissioner of education implemented, an accreditation scheme for higher education that lacked any real teeth. 132 among other things, it required the accrediting body (1) be national or regional (i.e. included more than one state) in scope, (2) 130 michael, supra note 126, at 228-29 (citing kenneth e. young et al., understanding accreditation 66 (1983); courts oulahan, the legal implication of evaluation and accreditation, 7 j.l. & educ. 193, 223 (1978)). 131 michael, supra note 126, at 229 (citing william k. selden, accreditation: a struggle over standards in higher education 17-20 (1960)). 132 michael, supra note 126, at 230 (citing matthew w. finklin, federal reliance on voluntary accreditation: the power to recognize as the power to regulate, 2 j.l. & educ. 339, 343-48 (1973)). 742 vol. 11:2 rethinking health app regulation serve a "definite need," (3) do nothing that might impact its independent judgment, (4) give access to the public about its accreditation standards, operations, and membership, (5) only accredit institutions that it determines meet its preestablished standards after an examination, (6) have some experience in accreditation, and (7) has gained "general acceptance" for its criteria and decisions.133 it is possible that congress and the commissioner adopted such vague and innocuous measures because they sought to avoid engaging in a review to determine which school would not receive funding through the use of accreditation schemes that were well understood by the educational institutions but not the general public.134 regardless, these standards, if applied to health apps, would set such a low bar for quality assurance that they can only be a starting point in the analysis. after the three mile island accident, members of the nuclear power industry proposed a set of regulations through the collaborative effort of the institute for nuclear power operations ("inpo").135 the official regulatory body, the nuclear regulatory commission, adopted the inpo proposals for personnel training as a condition for the grant or renewal of licenses.136 however, the inpo proposals, as adopted, only encouraged and did not require implementation of personnel training programs, and the united states court of appeals for the district of columbia circuit determined this was insufficient because congress had mandated that licensing be contingent upon such 133 michael, supra note 126, at 230 n.402 (citing finklin, supra note 129, at 347). 134 michael, supra note 126, at 229 (citing kenneth e. young et al., understanding accreditation 251 (1983)). 135 michael, supra note 126, at 233. 136 michael, supra note 126, at 233-34 (citing commission policy statement on training and qualification of nuclear power plant personnel, 50 fed. reg. 11,147 (mar. 20 1985); commission policy statement on training and qualification of nuclear plant personnel, 53 fed. reg. 46,603 (nov. 18 1988) (making the previous changes permanent)). 2014 743 indiana health law review personnel training. 137 this example is emblematic of the mixed history of decentralized certification programs. while the court of appeals struck down the inpo proposals, as adopted, on legal grounds (e.g., the regulation was not as strict as congress required), there still was an element of public policy at work. congress, speaking on behalf of the american people, demanded more personnel preparedness than the industry wanted to give. third parties certifying health app developers may fall victim to the same problem. a truly independent certifying body may be immune to pressures out-of-step with public demands, but it is more likely that these certifying bodies will end up favoring the entities they do business with (e.g., the certified health app developers) over the people vis-a-vis the government. if so, then the fda's requirements for certifying third parties must be strict enough to combat pressures from the industry. the optimal model for decentralized review of health apps may actually be found in a recommendation made by the progress & freedom foundation ("pff') to the fda in june 1995. 138 this proposal contained five main recommendations: (1) maintain or improve existing standards for efficiency and safety, (2) provide for third party review of new products, (3) retain the fda seal of approval, (4) facilitate application of cutting-edge scientific talent and knowledge to the review process, and (5) foster competition and management efficiency in the processes of research, development, and oversight. 139 all of these objectives track the goals of health app review put forth in this note. this is especially true for the last four objectives. the general purposes of health app review are to protect consumers' health and finances with fda oversight, ensure 137 public citizen v. nuclear regulatory com'n, 901 f.2d 147 (d.c. cir. 1990), cited in michael, supra note 126, at 234. 138 walsh & pyrich, supra note 124, at 992-93, (citing thomas m. lenard et al., the future of medical innovation: a new approach for bringing medical products to market, progress & freedom found. (1995)). 139 walsh & pyrich, supra note 124, at 993 (citing lenard, supra note 138, at 18). 744 vol. 11:2 rethinking health app regulation health apps contain accurate and up-to-date scientific knowledge, and promote commerce by signaling to consumers which health apps are trustworthy. unlike previous recommendations to the fda, which had encouraged a great degree of privatization within the drug approval process, the pff proposal would have left a relatively significant amount of control in the hands of the fda.140 the proposal recommended that drug certifying bodies ("dcbs") would perform most of the review functions that were currently being performed by the fda, and the dcbs would receive special licenses from the fda and be subject to its ongoing supervision.141 the level of deference given to third party certifiers would be at the discretion of the fda. 142 perhaps as an incentive to induce drug developers to agree to this process, pff proposed creating a tort liability defense for drug manufacturers who had received dcb approval.143 the pff proposals appear not to have been adopted by the fda and congress due to political pressures,144 but as applied to health apps, they may strike a welcome balance. 3. potential drawbacks of the decentralized certification program using third parties to certify health apps does alleviate problems like potentially high costs that could be caused by the centralized program. however, the decentralized 140 see generally walsh & pyrich, supra note 124, 987-98 (describing the historical development of drug regulation beginning with a recommendation by the council on competitiveness proposal in 1991, continuing through the 1996 pff proposal, and beyond). 141 walsh & pyrich, supra note 124, at 994 (citing lenard, supra note 138, at 18). 142 walsh & pyrich, supra note 124, at 994 (citing lenard, supra note 138, at 21); fda would become "certifier of certifiers" under progress & freedom found. privatization plan for product approvals, sponsors pay for reviews, 57 f-d-c rep. (the pink sheet) (june 26, 1995) [hereinafter sponsors payforreviews). 143 walsh & pyrich, supra note 124, 993-94 (citing lenard, supra note 135, at 28). 144 walsh & pyrich, supra note 124, at 996. 2014 745 indiana health law review program has problems of its own, some of which may undermine the entire objective of a certification program. third parties generally must be well known in order for the public to feel secure in purchasing a health app bearing their certificates. these days, anyone can design a fancy certificate on a computer and affix it to the description of an app. therefore, someone who has not gone through the official certification process could nonetheless legally establish an unsanctioned certification body, design a certificate, and lure the consumer into purchasing an app that would not meet the official certification criteria but still look official. this problem is not unlike the problems faced by certified personal trainers. there are hundreds of certification programs for personal trainers, but only a few of them are reputable. 145 consumers are left to sift through the merits of individual certificates and hopefully arrive at a sound conclusion.146 this problem ends up putting the cart before the horse for consumers new to the field. before they can identify high quality trainers, they have to learn about the precise field for which they have sought out a personal. as applied to health apps, this same problem could arise if sellers use unsanctioned certificates to market their products. consumers would be left to research the merits of individual certifying third parties in a field for which they have sought the health apps to educate them in the first place. the dilution of the effectiveness of third party apps could be mostly offset if the fda reserved some centralized authority. for example, the fda could license third parties to use certificates bearing text to the effect of "an fda approved organization." any entity attempting to induce purchases with unsanctioned certificates would be prohibited to use any text suggesting the entity has fda approval. enforcement of this rule would be the 145 jeremy hoefs, top 10 best personal trainer certifications, livestrong, http://www.1ivestrong.comlarticle/436098-top-10-bestpersonal-trainer-certifications/ (last updated mar. 3, 2014), archived at http://perma.cclx5lu-d6yq; jill schachner chanen, fitting in ftness, aba j., july 2001, at 64, 65. 146 chanen, supra note 145. 746 vol. 11:2 rethinking health app regulation responsibility of the fda, and it should be equipped with the ability to seek civil or criminal penalties for violating it. another problem is that third parties may not have the same degree of transparency as the fda. the motives behind fda certification decisions would presumably be benign, but for-profit entities have other responsibilities. public corporations generally have a duty to protect shareholders above all else, 147 and their interests may diverge from the interests of the public. for example, a private entity may offer to expedite the certification process for a premium. however, if the certifying entity does not expend extra resources on the review process, it may deliver a result that is both profitable to its shareholders and substandard to the public. third parties may have any number of other conflicts of interest that government agencies and agents would be forbidden from having. an example of this problem might come from the close relationship between the dcbs and drug manufacturers that may have formed had the pff proposal been adopted. under the pff proposal, drug developers would actually hire dcbs to oversee and advise the developer through the development process of the drug. 148 then, when the developer believed the drug would be ready, the same dcb would be responsible for deciding whether to officially approve the drug for the market, and it would submit its report to the fda.149 pff appeared to believe that because the dcbs would only be applying existing fda standards, the fda would typically defer to dcb findings. 150 this plan would leave a substantial amount of approval authority in the hands of the bodies responsible for helping the 147 e. norman veasey & christine t. di guglielmo, how many masters can a director serve? a look at the tensions facing constituency directors, 63 bus. law. 761, 765 (2008) (quoting n. am. catholic educ. programming found., inc. v. gheewalla, 930 a.2d 92, 99 (del. 2007)). 148 walsh & pyrich, supra note 124, at 994 (citing lenard, supra note 138, at 21). 149 walsh & pyrich, supra note 124, at 994 (citing lenard, supra note 138, at 21). 150 walsh & pyrich, supra note 124, at 994 (citing lenard, supra note 138, at 21); sponsors payfor-reviews, supra note 142. 2014 747 indiana health law review developers obtain approval. dcbs that already accepted money from drug developers would feel significant pressure to ultimately accept drugs after completion of the development phase in order to secure future business. at least under the pff proposals the fda would retain postmarket surveillance and could recommend pulling the offending drug from the market, 151 but this would be insufficient to protect a first wave of individuals negatively affected by a bad drug. any approach adopted for health apps following this model should hold third party certifiers liable for injuries caused by any health apps negligently approved. the only way to eradicate these problems entirely would most likely be for the fda to direct the operations of the certifying third parties to such a degree that there would be little practical difference between a centralized and decentralized certification system. this result, however, would be highly undesirable. therefore, one of the concessions of using third parties to certify health apps would be that a certain level of conflicts of interest with the public would necessarily have to occur. exactly what conflicts these would be or the limit to which society would tolerate is beyond the scope of this note but is certainly worthy of consideration. iv. conclusion the mobile device industry is still rather new, but the adoption rate of mobile devices has been astronomical. the number of consumers likely to be negatively impacted by apps like dermapps only increases. creators of deceptive or inaccurate health apps will only have increased incentives to design and market more, while the existing ex post review of offending health apps becomes increasingly unrealistic and ineffective. consumers are left to fend for themselves in the current health app market. they can sometimes rely on anonymous or pseudonymous testimonials from consumers, but 151 walsh & pyrich, supra note 124, at 995. 748 vol. 11:2 rethinking health app regulation someone has to be the proverbial guinea pig. the fda draft guidelines make proposals that would protect some consumers from some unreliable apps, but there are many categories of apps left uncovered by the guidelines, and consumers' well-being and checkbooks are left vulnerable. adopting a certification standard that would signal to consumers which health apps have been verified as medically reliable would go a long way in promoting consumer, and even physician, confidence in the health app marketplace. such a standard could be implemented through the fda, which would allow the greatest flexibility for fda review on a case-by-case basis, or through third parties certified by the fda, which would address many political issues and especially those having to do with the budget and national debt. if the fda were to determine a certification model applicable to the mobile medical devices, particularly those not requiring premarket approval, it currently intends to regulate, the decentralized approach may be the best fit. a certificate that a mobile medical device has met the fdas regulations may be nearly meaningless because all covered apps would be required to meet those criteria. the decentralized approach would allow private entities to set a higher standard, and the fda would not have to maintain two sets of standards for the same apps. this note only explored issues with substantive contents of health apps, but there are many more issues at play. furthermore, this note explored only a few models for centralized and decentralized certification, but the possibilities are endless. this is the beginning of a conversation on how to promote confidence and consumer protection in the health app marketplace by establishing an alternative to regulation. certification of health apps provides the customization and adaptability necessary to promote consumer confidence and protection in the modern technological age. the government cannot save consumers from making poor decisions in all cases, but as has been demonstrated, it can at least provide consumers with the tools to make well2014 749 750 indiana health law review vol. 11:2 informed, smart decisions about their healthcare by promulgating certificates for mobile health apps. transcript of the live symposium interdisciplinary approaches to medical nanotechnology: defining the issues * table of contents i. welcome and opening comments ............................................ 386 ii. nanotechnology: science, medical appucations & iupui resources ...••••••.•••••.•••••••.••••••.••••••..•••••..••••••••••••..••••.•..•••••..•••••.•••• 388 ill. thoughts on commercializing nanotechnology •.••.•••••••.•• 393 n. medical nanotechnology: the etiiical concerns •••••••••••• 399 v. legal issues in nanotechnology: new sizesnew issues 404 • the indiana health law review and the health law society at the indiana universi­ ty school of lawindianapolis thank the following speakers for participating in the symposium and providing their unique and infonnative perspe<:tives on nanotechnology, as well as for al­ lowing the indiana health law review to publish this transcript kody varahramyan, phd. vice chancellor for research indiana universitypurdue university indianapolis kyle salyers managing director of business development clarian health ventures david orentlicher, m.d., j.d. samuel r. rosen professor of law co-director, hall center for law & health indiana university school of lawindianapolis adjunct professor ofmedicine, indiana university school of medicine ralph hall, j.d. visiting professor ofl..aw,lndiana university school ofl..awindianapolis distinguished visiting professor, university of minnesota school of law emily mo"is, j.d. associate professor ofl..aw, indiana university school of lawindianapolis eleanor kinney, j.d., m.p.h. (moderator) hall render professor ofl..aw co-director, hall center for law & health indiana university school of lawindianapolis the indiana health law review would also like to give special thanks to ms. amy lewis gil­ bert, president of the health law society and ms. carsandra l. knight, coordinator for the center for law & health, who worked tirelessly to make the symposium a truly memorable event. 386 indiana healm law review [vol. 6:385 vi. possffile intellectual property law issues in nanotechnology .••••.••.....•••..•••.•..•....•••....•••...•....•.••..•••...•....•.....• 410 editor's note the following is a transcript of a live symposium entitled interdisciplinary approaches to medical nanotechnology: defming the issues. the symposium took place on april is, 2009 in the wynn courtroom of the indiana university school of law indianapolis. the symposium was presented by the iupui consortium for health, policy, law and bioethics, indiana university school of lawindianapolis, the indiana health law review, and the indiana uni­ versity school of lawindianapolis health law society. the symposium was designed to address introductory issues of nanotechnology across a broad range of disciplines by incorporating presentations from several different profession­ als into one event. each presenter focused on an issue of nanotechnology with­ in his or her expertise. following the presentations, a brief moderated panel discussion was held to allow audience members to ask questions of the presen­ ters. due to technical difficulties, the transcript was unable to include the panel discussion. to preserve the dialectic flavor of the transcript, the portion of the tran­ script presented here has been edited in form but not in content. during the editing process, a distinct effort was made to retain both the original tone of the panelists' remarks and the verbal mannerisms of the individual panelists. the power point slides from each presenter are available at www.indylaw.indiana.edu/newslbrowse.c:fin. i. welcome and opening comments professor kinney: welcome and thank you for coming this after­ noon. at any rate, what we have in store this afternoon is a program sponsored by the hall center for law and health and its health law society and indiana health law review, our law school, of course, and the consortium for a health policy, law and bioethics, iupui signature center. before i go onto the merits i would like to advertise our consortium, bring it your attention. and this is -there are brochures outside. what we are up to with the consortium for health policy, law and bioethics, iupui, a consortium of three policy, three research centers in three different schools, is to provide opportunities for interdisciplinary environment that it enhances research, educa­ tion like we are about today, and of course, service and that's what we are about today, as well. so i urge you to please take one of our brochures and become familiar with the consortium. we have a website; we are anxious to include all who are 2009] nanotechnology: defining tile issues 387 interested in our activities. i would also like to recognize before we open, mo­ nica m.c. allain of the birck nanotechnology center at purdue, thank you very much for coming. and i would be remiss, there many others in the audience and i definitely should recognize including our visiting professors ralph hall who will be on the panel today. but i would like to specially recognize amy lewis gilbert who is the president of the health law society and has put together this conference as part of an advanced clinical experience in health law where we have ad­ vanced clinical experience in any ranges oflaw, but we have some very excit­ ing programs development activities under the advanced clinical experience, and i trust this will be the same. indeed our advanced clinical experience has occurred seven years ago, and now is a national conference that we have every year for which we have to get hotel space for outside speakers and guests who come from around the country. at any rate, without any further due i would like to introduce the speakers now before each of them speaks and kind of give you a heads up, as to why we invited them to speak. and then as they come forward, we'll just move along through the program and at the end we'll have a panel where there is an opportunity for the speakers to comment on the presentations of the other speakers, and also for you to ask questions, and we urge to be vocal and asking questions. our first speaker is dr. kody varabramyan, who is our vice chancellor for research at iupui. he has really brought a real breath of fresh air, and a lot of energy to the research enterprise of this campus. that's one of the reasons we invited him, but the other reason we invited him is he probably one of the few speakers that we have today who actually know something about nanotechnolo­ gy and that he is an electrical engineer. you'll be hearing from several lawyers and business types, and sometimes our knowledge is derivative, but it is nice to hear from a scientist at the start. we have then kyle salyers following up from the director of business development clarian health ventures, and he is very knowledgeable about how we get these great ideas from the laboratory to where they can actually benefits some folks. and i suppose that's where the lawyers come in. we'll fol­ low up with dr. david orentlicher who not only is a lawyer, but also an ethic­ ist, and a politician. again, very well educated, and highly accomplished. and when i say well educated on the part of all these speakers, we are taking har­ vard, brandeis, indiana university, it's a very distinguish group, duke, ifl might add my own alma mater, but at anyway. so david will talk to us about the ethical challenges that are involved, and he brings a little sense of political reality to the subject as he served in the indi388 indiana health law review [vol. 6:385 ana house of representatives from 2002-2008, and then we will be followed by emily morris our new associate professor of law. emily is a tremendous asset to our health law program and to our program generally at the law school. she comes with knowledge of intellectual property, issues in the phar­ maceutical and medical device world, and i think you are going to enjoy what she has to say. we'll conclude with ralph hall who is our distinguish visiting professor here at the law school this spring, hopefully next summer, the next fall, and beyond but in addition to spending time here is also a counsel ofbaker & da­ niels here in town, and he is probably one of the most knowledgeable people, knowledgeable lawyers i know about science. and not only he is a knowledge­ able practicing lawyer, but he has a tremendous sense of the academic enter­ prise and what we are about in law schools. so we have a very distinguished panel today. we will start with kody v arahramyan, if you will come forward, and i think we are in for a really good afternoon. thank you. ii. nanotechnology: science, medical applications & iupui resources vice chancellor v arahramy an: well, good afternoon! i am kody v arahramyan. i am very happy to be here. my presentation is on na­ notechnology and i am going to cover the science, medical applications, and some of the iupui resources here. i should also say that this maybe an ambi­ tious goal covering this really three distinct topics from science to medical ap­ plications to the resources that we have on campus to cover that within 20 minutes. but pll do the best i can. maybe the first slide would be appropriate to provide a definition for na­ notechnology. and quite frankly, if you look up there to see if there is one defi­ nition that most people adopt or use. the answer is, no. so this definition is a combination of some other definitions and little bit mount thinking and some other staff members we have that we came up with this one here. so nanotechnology is the creation of functional, materials, devices, and systems to understanding and control of matter or dimensions in the nanometer scale length where newer functionalities and properties of method are observed and harnessed for a broad range of applications. so this is meant to be as brief as possible of a definition that we could come up to capture the field of nano­ technology. the next slide, actually, provides a very brief history of nanotechnology, and actually a key point of this slide is that the term nanotechnology was coined 2009] nanotechnology: defining the issues 389 in mid 70s. but just because we started then increasingly calling this field nano­ technology, and then there where some key inventions like in the 80s, like this scanning tunneling microscope and all of that; that really started launching the field. however, the point that also needs to be made is that actually nanotech­ nology in one form or another has existed for thousands of years. and in fact, if you go back to about say, 2,000 years ago the greeks and romans were already using sulfide nanocrystals to dye their hairs. then about 1,000 years later, or about 1,000 years ago in the middle ages, gold nanoparticles of different sizes were used to get different kind of colors for stained glasses, stained glass windows. so the field of nanotechnolo­ gy from some points of view has been around for thousands of years. but, of course, in the last few decades you may say that we really have got into the science of it, and then technology of it, and now increasingly we are getting into the commercialization aspect of it. all right, now those of you who may not have an idea, what is nanoscale? well, this slide is meant to assist us with that. on the left side we see the earth, which we should have some idea about, that is an object that is very large. well, how large, is exactly of the order of 1.2 7x7 meters. all right, in the middle, we see a soccer ball, and that's about 0.22 meter. i mean 1 meter is about a distance this long. so a soccer ball is about this much wide in diameter. on the right side, we see this nanoparticle known as a form of carbon structure fullerene, and the size of it is 0. 7x9 meters, or 0. 7 nanometers. so one meter is about this long, and one billionth of a meter, ifl take one meter and divide up into one billion parts, the one billionth part is one nanometer. now the other point of this slide is that if you think of the earth and the soccer ball, the earth is about 1 0 million times larger or the soccer ball is 1 0 million times smaller than earth, but if you go from the soccer ball to the fulle­ rene, which is a nanoparticle, actually the difference is one billion times small­ er. so think about it, the earth with respect to the soccer ball is 10 million times larger or the soccer ball is smaller. but from the soccer ball to the nanotechnol­ ogy size, dimensions of objects, we are talking about one billion times in differ­ ence. one other way you can think about it is, if you take one of your hairs out and think of the diameter of your hair. all right, we can have of the order of 100 million of those nanoparticles place on the diameter of your head, about 100 million. all right, well, but what is the big deal about this business of a nanoscale? 390 indiana healtii law review [vol. 6:385 well, there are a number of tremendous advantages. one of them is that, if you can make devices that are ever smaller and smaller and smaller, then you can't take bunch of them that do different operations that integrate them in a very small size area. now the system of this kind that we are the most familiar with is the mi­ crochip, which is the brain of our computers. actually these days is no longer accurate to call it microchip, it's really a nanochip. why? because inside that chip, the individual devices are already in the nanoscale range-size, and a mod­ ern nanochip has of the order of one billion individual tiny little electrical de­ vices on it. all right, now it is because of that capability of reducing the size and hav­ ing one billion tiny little devices doing operations on the chip, which is the brain of our computers that; that is why we can have a pc sitting on our desk with such strong capabilities. so that's one of the great advantages of reducing the size of devices into smaller and smaller dimensions. another way to look at it is that if we have not done this, if we wanted to build a computer of the power of our pc, of what a pc on our desktop does by using the 1950s technology, which means that the individual devices would be made of vacuum tubes. would you know what will be the size of that pc? all right, the size of that pc would be of the order of the size of this building and actually you would need maybe 30, 40, or 50 people actually to go around and continuously replacing the unreliable vacuum tubes. and by the way, you would also probably require at least half of the power consumption of this campus just to power that computer. so again these are all the arguments to why it's goodness to be able to mi­ niaturize something. so this is not just a novelty or something nice to. alright, but there are some other interesting things that happen, is that when you make something smaller and smaller and smaller, actually you are also increasing the surface area of that object with respect to its volume, and there are some advantages about that maybe i will give you an example in a moment. the other interesting effect is that you can take a typical material in bulk size and has set them proper design characteristics. now you take the same exact material and make it into the very small na­ noscale size. on one behold, you will find that generally physical, chemical, optical, mechanical characteristics of material has dramatically changed. maybe in its bulk size the material is not chemically reactive, maybe optically behaves certainly, but the moment you reduce it in size, those characteristics change. 2009] nanotechnology: defining the issues 391 so going back to the gold nanoparticles that our friends in the middle ages used to get different colors coming out of them, actually the different sizes of those gold nanoparticles would give you different wavelength of light. so that was the whole point. so effectively nano-size materials from a scientific point of view, we can make them to behave if you know what we are doing in them to acquire the properties that we desire them to acquire. and as well as applications of nanotechnology -already, there are in­ creasing areas where nanotechnology is being applied from information tech­ nology area, i already talked to you about the nanochip to medicine, i have few slides about that in a moment, to the energy area and as well as consumables. now not everything about nanotechnology is wonderful and beautiful. like anything else in life, there are also some issues. for example, when you make these nanoparticles, if you don't know how you are processing them, how you are making them, it can be dangerous, maybe not all nanoparticles, but some of them, if they are inhaled for example by the people who are processing them. it can be also harmful in some cases to the environment. so all of these as we are speaking, they are also people including at universities that they are studying all of these effects and they are becoming more and more important. so we have to, for completeness, we have to keep that in mind. now, i guess, i just want to highlight that we can have different kinds of what we called nanoscale materials. some of them can simply be nanoparticles where, for example, if you think of gold, if we have chunks of gold in the na­ nometer scale range, we called those gold nanopaiticles. we can also --i guess, the slide there, almost in the middle there is actual­ ly showing you that we can have the technology to take individual atoms and put them on a particular substrate in any way that one wants to do, and by doing that on an economic scale effectively, you are changing the properties and cha­ racteristics of that material. all right, this slide shows other kinds of nanoscale materials. and actually the picture on the right, like the lower one, is showing you what they called na­ nowires. now nanowires there, you can think of them like the hair on your head except that this hair is made of all sorts of different kinds of materials. the ma­ terials can have electrical properties, mechanical, chemical, and optical and so forth. now this is an example where if you have nanowires stacked up next to each other like this, is an example where you have maximally increased surface area with respect to the volume where this material is. so if you used this rna392 indiana health law review [vol. 6:385 terial, for example, as the absorbing surface in a solar cell to absorb the lights of the sun and produce electricity. that means that the more surface area you have, the more electricity you can produce. so this means that in a very small area you've maximized your surface area. and effectively, you can have something that maybe the size of a penny, but the surface areas maybe the size of a football field. in other words, if you just as though if you walked over all the surfaces available there and put them together on a flat surface, it could be the size of the football field. so these are all important considerations about nanomaterials, but nanos­ cale materials can also be ofbiological type and bionanomaterials could either be simply be biological materials that or on the nanoscale range like the pro­ teins, enzymes, dna, rna, peptides or they could also be synthetic materials that are used in biomedical type of applications. okay, i have five minutes. well, there are different approaches for the :tabrication ofin other words to take nanomaterials and make them into certain kind of devices and systems, and again because of my time limitation, i better move on. these are some ex­ amples of actually completed systems where you have nanodevices combine with devices on the micro and major and microscale. for example, you can have nanochips and some other systems of that kind. fuel cells, for example, are examples where the materials inside the fuel cell to increase its efficiency are increasingly made of nanomaterials. lab-on-a-chip and drug delivery systems. again, these are systems that some of which can also be implantable and they have great functionality be­ cause of having bunch of small size devices combined on the system there. now nanomedicine is effectively the field where nanotechnology mate­ rials, devices, and systems are applied in medicine. these are applications where you can develop cures, for say, cancer, and diseases, and i guess again because of my time limitation, i will move on. i have a video here. (video play­ ing) well, the next slides are really more or less the repetition of what you saw in the video as far as some of the examples where nanotechnology can be ap­ plied in the health care area like for treatment against cancer, targeted drug de­ livery applications where the drugs are delivered exactly where you want them to go rather than flooding the whole body, like if you do chemotherapy with very poisonous drugs, but you can send them exactly where they are suppose to go and release the amount of drugs only at the right time and at the right place. other examples where we can have nano-based system for detection and diag­ nosis of, again disease. 2009] nanotechnology: defining the issues 393 i will just been spent, maybe, a minute or two in this fmal part. since last summer, you may say, that we now have a new initiative on the iupui campus where effectively, previous to last summer there were bunch of people here and there in different units on campus doing nanotechnology oriented work and this integrated nanosystems development institute or indi is meant to be like an umbrella organization that brings together these entities and coordinates their work and their efforts. we also have already a number of existing centers on the iupui campus, like the center for regenerative biology and medicine, the lugar center for renewable energy, and all the other centers listed there, that for some of the work they do like the lugar center, one of their big projects is to make fuel cells, and to make better fuel cells, you need nanomaterials. and effectively, it's like indi is meant to be a collaborative entity to assist all of the centers in a very collaborative and cooperative manner. i will just move on and this slide effectively highlights a number of projects that we have on the indi. a number of projects are oriented towards biomedical applications of nanotechnology, energy applications, and informa­ tion technology applications. we already have a reasonable set of resources that are available for processing measurement and as well as computational work. but at the same time now through this sort of coordinated effort, we are also looking at what are some of the areas where maybe there is need for enhance­ ment of resources and how to go about effectively securing them. so having said that, i believe that's my last slide and i thank you for your attention. 111. thoughts on commercializing nanotechnology mr. salyers: good afternoon, my name is kyle salyers. i am the managing director of business development at clarian health ventures. first, i will start with my disclaimer and that is i know nothing about nanotechnolo­ gy, but what i hope i can speak to a bit is may be some more generic observa­ tions about the process of commercializing the technology, and i hope i can provide a bit of may be integrated perspective, in that my background has been informed by both involvement from a public policy and economic development perspective as it relates to commercializing various kinds of technology in­ volvement from an academic perspective both at iu, purdue, and rose­ hulman. from a product development perspective, most notably at rose-hulman ventures and as an investor, principally a medical investor, now at clarian health ventures. so i hope to add those perspectives to the discussion and as well as some observations maybe from an operational perspective being a di394 indiana healm law review [vol. 6:385 rector on two medical device companies. clarian health ventures: two quick commercial slides, i won't spend a lot of time on this, but we were formed about two years ago and as an independent for-profit investment subsidiary ofclarian health partners. so our mission is to invest in early-stage medical technology companies, technologies which are both born within the iu and clarian system, as well as technologies that come to us from the external marketplace and do not only present a good economic value proposition, but are highly synergistic with clinical centers ofexcellence within clarian and medical research centers of excellence within the medical school. we have four investment professionals and have made five investments to date, two of those are in diagnostics, and three of those are in the medical de­ vice field. so our investment thesis, as a firm, really has four principles. first, is to generate a market rate of return. to do that based on the second principle which is being consistent with clarian health partners mission. we feel then, in service of that, the third and fourth principle relate to what we feel is our distinct advantage in the marketplace. so what's our unfair advantage as an investor and we feel that, that really is two-fold. first, is hope­ fully, we are in a position to make more informed judgments on technologies upfront because of our access to expertise, clinical expertise, and after having made an investment, we feel we are uniquely positioned to add value to the company based on our proximity to clinical assets. that's kind of our basic in­ vestment model. i googled this afternoon commercialization, and i was going to put a defi­ nition up and i thought well let's see what google has to say? so there were 3.4 million hits if you put google at least as of 10 o'clock this morning, which those numbers probably have grown even since then. so this is kind of my own very simplistic views and what i think about commercialization; again, a generic perspective and that is an acknowledgment first that it does start with a core innovation, then reducing that innovation to practice, then protecting, repeating, and testing that practice, funding that appli­ cation and then continued development of the practice itselfleading hopefully to the dissemination of that practice. i am using practice really for proxy of may be a technology, but proxy for some repeatable set of processes that we are able to now put into place, and then ultimately from an investor's perspective, op2009] nanotechnology: defining the issues 395 timal commercialization were to take place when we are able to monetize those benefits for an investor. this is not meant as a joke. i know you can't read it. it's my one and only slide that's nanotechnology specific which is why you can't read it. so you can't ask me any questions that you have. well, maybe you can read it, i don't know. but i thought it was -it was, kind of, interesting because as i read this, i had a couple of takeaways and i will read this ifyou can-excerpts of it. this is from industryweek, entitled "nanotechnology commercialization efforts continue", "as potential nanotech sales grow, so too does scrutiny. the nascent nanotechnology industry is facing many of the same challenges expe­ rienced by any young technology: lots of hope, lots ofhype, and lots of scruti­ ny. even the appropriate definition for nanotechnology remains a matter of some debate," which is, by the way, i contend like the ultimate definition of success. when everything becomes the defined under your category, no one really knows the definition, but they lump it in a broad cat and do a broad cat. so a march report on nanotechnology which was spearheaded by repre­ sentative saxton, out ofnew jersey, a ranking member of the joint economic committee, of the united states congress, speaks to these rapid technological advances by saying, "advances in just the last five years have proceeded much faster than even the best experts had predicted. looking forward, science is likely to continue outrunning expectations,'' the report states. so the next paragraph then goes on to talk about some of the public policy considerations and it acknowledges the fact that undoubtedly regulatory processes and potentially political oversight would need to be much more ro­ bust in this area. the next set of sentences highlights a couple of statistics and these are 2006 statistics, statistics being what they are; i don't know that the numbers are may be as important as the specific metrics that they are tracking, which is what i will speak to in the next slide, but what these particular statistics cite is that in 2006, $50 billion of nanotechnology-enabled products were sold worldwide, $12.4 billion was invested in nanotech r&d. corporate spending of that r&d amount was $5.3 billion, $6.4 was from government institutions; these are worldwide numbers. then venture capital investments, flowing towards nano­ technology, was expected to reach $650 million in that same year and then it closes with a quote here saying that "nanotechnology leaders are showing both the optimism and uncertainty of pioneers." so my takeaway from this from a measurement standpoint was, okay, how might we asses the market for in this case, nanotechnology commercializa­ tion, again, i would probably generalize this in terms of the health of a market 396 indiana health law review [vol. 6:385 for commercialization of most technologies and there are a couple of measures here which i think we certainly pay attention to as venture capital participants and related to technology, but i think has some applicability in multiple areas and that's the following. these are six government funding flows, corporate investment in r&d, intellectual property output, private risk capital flows, the size of the ~et for end products, and then this broad kind of catchall category of constraints and that's not to suggest it's negative or positive, but rather just an acknowledgment that as we begin to get momentum on the first five, we begin to get in some public policy and regulatory types of considerations that we need to be mindful of. so having said all that is context; what i did here was is in these next couple of slides is just maybe to have a little bit of fun with this and say, okay, what's some commercialization top 10? i mean as i look back at not only some of the public policy considerations that i have been involved with but the 50 some companies we invested in at rose-hulman and then the most recent ones we have done, the five at cla­ rian health ventures, what were some top 10 observations relative to the commercialization process and the first speaks to the continuum of funding. if i were toi should have made this change, i don't know that it's so much funding as it is resources, a continuum of resources to match the appro­ priate developmental stage of a project and what i mean here is just a systems level view of governmental resources, and down the foundation resources, mar­ ket return oriented resources, and have that systemic view of matching what we call the color of money or the color of resource. point two is just a distinguishment between where research begins to evolve into development. so i kind of talk about it in terms of the pursuit of knowledge to the probability of application and where that tipping point occurs in the commercialization process. usually, indicative of many more engineers sitting around the table looking for the true application and the design-test­ build process. number three is just an observation that takes all kinds. it takes partners from all sectors of multiple disciplines. point four is a more tactical observation, don't forget the freedom to oper­ ate; oftentimes we found the propensity to jump very quickly to the protectabili­ ty of intellectual property sometimes bypassing the first step of, "hey! can i even do this and am i in a freedom to operate position?" 2009] nanotechnology: defining the issues 397 investor's demand a return commensurate with risk; it's often about fit versus good or bad. so the risk-free rate on the 30-year treasuring now is what 3 .6%, 3. 7%. as you move up, different elements of risk, as an investor you are asking yourself from a finance perspective, of course. so what additional ele­ ment of return can i realize based on that additional element of risk? so if you have a venture capitalist or a private investor say, "gee! i need 30% rate of re­ turn." you are like, "oh my god! this person is -just how greedy he is?" well, it's predicated on the risk free rate, right? i can get almost 4%, if taking on no risk, i need to based on the dispersion of those returns and in fact if maybe one out of ten will succeed, i need to shoot for 30% for it to even itself out. talk to end users, in my field, my best friends and what we do, other nurses. they will tell you, right? they are in the field, it will work, it won't work, and they understand the workflows. so just an observation in the com­ mercialization process early on, talk to the end users. clearly distinguish the technology license versus a company build strate­ gy, there are a lot implications, i think, higher education and others who have intellectual property or blessed with intellectual property in their institution, how do we push that out, do we build companies, or do we license the technol­ ogy? point a speaks to the importance ofand this, at times, can be a difficult transition. it speaks the importance of the initial innovation relative to the commercialization, and the success diminishes over time and this isn't just to say not that the founding technology is not important but it's only to acknowl­ edge that fact that over time along critical path of development, multi­ disciplinary inputs are going to be required. so it's about bringing in the management team, it's about bringing in the capital, it's about bringing in lots of other multi-disciplinary skill sets to com­ pliment that core technology, and so sometimes from a founder's perspective, that can be a very difficult reality to come to grips with and then as you are add­ ing incremental technology improvements which are more oriented towards application those two become very important. point nine; beware of the progression into new risk factors. so if we think about the commercialization process right, it's almost binary in terms of the technology, it works or it doesn't work. so you prove over time that with rea­ sonable probability this thing can work, health care in particular; work towards commercialization; we begin to thinking about regulatory risk, what does the fda think about this? being to get into reimbursement risk, will somebody pay for this, then you get into these market issues and you get in these management execution and then lastly a list of the liquidity risk as an investor assuming 398 indiana health law review [vol. 6:385 grand commercialization success of this product or this technology, can i get out of the investment, will this companyultimately become liquid in some way? point ten, being-an undergraduate degree from depaul university, a lib­ eral arts institution, i love number ten. i believe this firmly that technology commercialization is the ultimate multidisciplinary skill set. i know i have got about 60 seconds and i have about three slides left. i will work through them very quickly. the last three slides are examples of tem­ plates that we use within clarian health ventures to help come to judgments. this first one is pretty common. most of you have probably seen different iterations of this. first brush oftechnology or early stage business we are look­ ing at, we are looking at these three factors. we are assessing the technology, the ip, the product, the market, the management, the. deal structure and exit scenarios and associated probabilities with them. the second, again this is an unfilled matrix, but this is always an interest­ ing one to look at from the medical technology perspective; looking at it through the lens of a provider such as clarian. typically we populate this ma­ trix with what's called predicate, either predicate surgery or predicate technolo­ gy and then proposed technology or proposed innovation and you lay it across this matrix. so we say clinical indication is to say so what is the clinical indication that this new technology is targeting, what intervention is then taken, what is done to address those indications, where is it done, which is a setting of cares, inpatient, outpatient, then payment, what are the economics of this? so this is a way when we are evaluating the potential impact within a pro­ vider setting of a new technology, it could be a nanotechnology, what does this matrix tell us? not the only way we make the decision, it's one process we use to inform our decision-making process. then the last, this is another matrix we use which relates to risk manage­ ment. i alluded to this early on. we both try to balance our portfolio of invest­ ments against this, but in any one particular technology or one specific company, we are also constantly reevaluating where are we from a technology risk standpoint, how apt or how able are we to protect this technology, how re­ liable is the technology, how dependent is the business model on the technolo­ gy? again is it binary or not? if this thing doesn't work, are we done or do we have a plan b? regulatory risk, what's the fda process, what's our regulatory path, how much time and how much money will be required to move through to market, 2009] nanotechnolooy: oefinjng the issues 399 reimbursement, can we get paid for this market, management, execution, liquid­ ity, and so forth? so, again, i just want to provide a three we use many, but these are three of the tools that we use as we are evaluating the potential commercializa­ tion success of a medical technology. so with that, thank you very much. iv. medical nanotechnology: the emical concerns dr. orentlicher: very good, it's good to be here. thanks for includ­ ing me. i will now talk about the ethical concerns and since kody did a great job, going through the science, i can skip my first slide. as you said, this is not new; he gave some good examples of nano-particles, lots of other natural ex­ amples, they are indicated here and we've generated nano-particles for decades now or centuries even, with some of the things we do. so you are getting ex­ posed to nano-particles all the time. but now we're going to just increase that by some of these new scientific and medical developments. kody mentioned some of the important medical uses, collection of more data. that was a nice video tape that talked about how we can do more efficient and nuance job of detecting abnormalities of blood chemistry and genetic makeup, cancer cell detection, more focused delivery of drugs in that video tape. if you go to the website of the national cancer institute, you can track this. they are really doing a great job of keeping us up-to-date. but here's this website and you see there's nanotech news, nano-particles delivered gene therapy killing tumors, nano-particles open door to cancer prevention. if you go to that link, they talk about a t -derivative of natural substance that they think has cancer preventive properties, but if you just drink it or deliver it in the nor­ mal way, it degrades very quickly and doesn't hang around long enough to knock off any nascent cancer cells. but with nano-particle delivery, you can get doses that are effective, at least, in these early studies. so that's very exciting and nano.cancer.gov if you want to follow that and then there are some things that i would be interested when we get to the panel to hear what kody' s thoughts are. when you read people are speculat­ ing, what's the potential for nano-particles, and i guess, there is a lot of exagge­ ration here and i'll talk about that problem. but some writers talk about the ability to develop these nano-scavengers that will come in and remove our in­ fectious agents more effectively than antibiotics and toxins and repair or replace damaged cells. and since that's what causes to age the rehab cells that become deteriorate overtime, may be we can forestall age. i'm skeptic but may be there's something to that. nano devices to improve the precision of surgery, then you hear people talking about the ability to enhance our normal attributes, 400 indiana heal1h law review [vol. 6:385 to give us radar like visions, supernormal hearing and so on. the ethical concerns; well, one of the concerns is, as rve suggested with this previous slide, is new technologies are often overhyped and i'll now give you a quote from a 2004 article in the annals of the new york academy of sciences. over the next 15 years, we will see an acceleration of innovation, change and disruptions on a scale no civilization has ever seen before. nano scientists disruptively astounding for the potential it may hold to alter much of what we know. and this is just, as i said, it's a pretty respectable journal; the annals of the new york academy of sciences. so will it be overhyped? and it's not surprising if you read this kind of stuff. i mean if you're a developer of a new technology, you want to persuade venture capitalist like kyle here to invest clarian's money. so you want to make it sound exciting, and we, ethicists, are guilty that too really maybe we made (inaudible) with the human genome project, where we spend trillions of dollars to decode the genome and a few percent was set aside for ethicists and legal scholars. that was kind of a gravy change for the field for a number of years. i think ethicists are hoping nano-technology will tum up the same way. so it's kind of a drumming up of the ethics problems. but the problem is if we overhype a new technology, and they tend be, will we divert funding from better uses? it's great to treat cancer but there are a lot of preventive things we could do, like turning people from smoking that we might get more for our bank for our buck. a major concern is, is in theand i'll just give you some other examples of overhyping. there was an article published some while ago, one of their ear­ ly proponents of nano-technology who claimed that someday we will be able to build the respirocyte, a little nano-particle that's 236 times -i don't know how it came out 236 times, by the way. 236 times more efficient than red blood cells in delivering oxygen. so you send these little respirocytes into our blood stream with little nano-computers and they will tell us, our physician our current state and our physician can tell our little respirocyte exactly how much oxygen to deliver, and if we're going out to run a marathon, they will up the oxygen and if we are sitting on a computer, we get over a little bit less. one thing that's been pretty much repudiated by scholars, but they were some of the early writers who talked about these nanobots, the nano-robots, that would take on life of their own, kind of a 2001, 3001, where they come into our body and then some way reproduce some out of control and takeover and over­ run humanity. well, that isn't too much talk about that anymore, but that's the kind of thing very science-fictiony in the writing. the other thing is in the overhype, failure to account for potential risk for 2009] nanotechnology: defining the issues 401 the serious scholars and kody acknowledged that there are important risk that we have to take into account when you reduce these. as you said, they're not just little particles; when you reduce the size, they take on different properties. one of the concerns as one of the positive things about nano-particles is they are lighter, they're more durable so you get very strong, light particles when you reduce the size and they are durable but their durability means they'll be more persistent in environment. so our landfills are now filling up with plastic and now they fill up with nano-particles. the other concern that environmentalists point out, because they are so small, you need very sensitive, very expensive equipment to detect them. so you may not not everybody has that. so, we may not be aware of the envi­ ronmental hazards because it's hard to measure their presence. there are concerns of the smaller size that will make it more likely to be inhaled and cause respiratory problems. people talk about, can they just-nor­ mally, things don't get into through your skin unless you have a cut but nano­ particles are small enough, may be that if you flex your wrist, that may be some nano-particles can sneak in there. that greater surface area has a lot of impor­ tant biological benefits, lower doses as kody said but may they can also hide in the flammatory responses. and one of the concerns that you are see as people write in the area is be­ cause of the possibility of overhyping and the risk of overlooking, unknown risk or even known risk is that the public will be scared and you'll read a lot about the concern in the field that we not repeat what happened with genetically modified foods. if you live in france or in other parts of western europe, genetically mod­ ified foods have been driven out of the market, not necessarily for good rea­ sons; often there are benefits to have a genetically modified food but they got labeled as frankenfoods, and even legislators in our state in country want to have labels that if your cow has various hormones, then you got to label the milk and make sure you don't get involved with any genetically modifies foods. even though, for the most part, the risk had been exaggerated. so one of the concerns is that we lose public support for some very important advances. risk to privacy; our common concern. if we develop these nano-chips that could be implanted or run through the body that can find even more compre­ hensive in nuance data and then we can download it into a computer, the good thing is, physicians know more about your needs and can treat you better but the risk to privacy are even greater if people can hack into the computer or into your chip and find out all this information. so we have to make sure that we have the safeguards to protect people. 402 indiana heal1h law review [vol. 6:385 then here is another thing that i suspect is more on the science-fiction side but you read about, people tell me about these neuro-implants that can improve cognitive ability and allow us to communicate with each other just through our little nano-chips in our brain and people would be monitoring. i suspect that is not going to happen but if it ever did happen, we'd have to be worried about privacy there. the over-identification of illness concern; if we have these ability to start, picking up these cell changes and blood chemistry or have subtle changes in our dna or fmd cancer cells sooner because we've got these nano-detectors that are smaller and can pick up these abnormalities sooner, will we start being over-identifying illness? my guess is that a lot of people have cancer cells that pop up and then the body disables them before they reproduce enough but now that if we can pick up, identify these little cimcer cells early and sooner, when we will make the cancer diagnoses, how many will it take; one cell, fifty cells, a thousand cells. if we start picking up these abnormalities sooner and identify people at risk or even, as i say, starting to label them with disease, will we pro­ voke unwarranted anxiety in patients or will we lead to over-treatment of risk factors? we have that debate already with prostate cancer; how much should we be doing measuring prostate-specific antigen androgen and men who are sixty­ five and how much should we be treating prostrate cancer and men who are sixty-five or seventy. there are probably a lot of men who are getting treated and getting tested who shouldn't be. so, the concern is that with nano-technology, we would magnify all those concerns. the other concern is, sort of, the enhancement versus treatment and again, this gets into and how much i am interested how much of this is likely, but you read some readers the whence i gave you the guy, that overhyped quote i get in his article. in that same article, he talks about all these remarkable pos­ sibilities for nano-medicine. hence memory that will be able to recall every­ thing and he has also talked about also disabling traumatic memories, so they don't dog you for the rest of your life. i think kenny peny is probably looking for one of those options. he was terrific at the masters this past weekend. infrared night vision, long-ranged vision, wide spectrum here, who knows how all that is. but if we can do any of these things, then a lot of scholars start getting worried about the difference between enhancement, a lot of people are worried about enhancing normal attributes as opposed to treating disease, and we go through this debate now with steroids for athletes, prozac to make us feel better and lots of other drugs that are out there. now, there is a lot of ambiva­ lence about human improvement; i give you a couple of examples where we commence self-improvement. 2009] nanotechnology: defining the issues 403 here is jarred and his before and after pants and you may recognize the government of california, arnold schwarzenegger and his pre-political days, and we all, we admire people who become accomplished musicians and innova­ tive scholars. on the other hand, we are not always very enthusiastic about ef­ forts of self-improvement; barry bonds and his steroid use. michael jackson; i am not sure this has ended up self-improvement, but that was the goal, involv­ ing his plastic surgeries and things. so this tension, even without getting into all of the speculative aspects of nano-technology, anytime we have sort ofbrave, new world, new exciting tech­ nology whether it is genetic engineering or nano-medicine, people get very concerned. there is a lot of ambivalence and it's illustrated in literature, people get worried about, trying to improve the human condition. as i say, even if it's pretty even, given what is plausible and already happened with nano­ technology; doctor jekyll i mr. hyde, frankenstein, genetic engineering, people get worried if we try to-on one hand, we want to improve the natural state; on the other hand, tampering with nature, people start to worry, we are going to mess things up. genetic engineering, there are lots of movies about the potential horrors of genetic engineering. when we talk about artificial methods of reproduction, people get nervous; the cloning debate. anytime we talk about changing the way life has dealt with, people get worried. this is going to be a problem when we deal with nano-technology. people very-why this ambivalence; people aren't comfortable with change that we went through that with surrogate parent­ ing, surrogate motherhood. if you remember, go back to the baby m days, people got really worried about; how can you've kissed this way. now, nobody even notices that surrogacy happens fairly regularly. cloning is the more recent example of whether we can deal with new ways of having kids. part of it is the history of abuse. we know that in the past, we have mi­ sused technology. so people worry that in the future, we will misuse this, espe­ cially, again, we are trying to use these new technologies to improve the human condition and the history of eugenics movement and abuse in indiana, in our country, and in nazi germany. and then people talk about concern for personal identity; if we can have these technological interventions that can help us see and hear and think and move more effectively and then are we doing it our­ selves, how much of it is personal achievement, how much of it is the technolo­ gy. so when bobby bonds, with his steroid, pumped up muscles, hit 70 home runs, is it the steroid or is it bobby bonds that hit the home runs. so people get worried about that and if we become more and more wired neurologically, if that is ever possible, where we allow uniqueness dissipate, is that so also bad anyway? that is the other thing if why are we so worried about all of this. 404 indiana healtii law review [vol. 6:385 this ties in why we worry about it. well. the undermining event for it, if we can turn to nanotechnology, will we suffer diminish, try to succeed, no pain no gain. if you can pop a;pill and your muscles bulk up or you can stay up for your exam or you can do all these other things, people get worried about that. is that bad? right, do we need to kind of suffer through life and work harder? the other way to look at it is this about just not exposing the myth of success based on effort, sort of, want to believe that people succeed through bard work. some­ times they do but then sometimes you can be the grand-the son of a president and get elected to the presidency, maybe 12 years later. now the important concern and this one i think is real, the most real, is the widening of socio-economic disparities. anytime we have a new technolo­ gy, it costs money. i don't know what the budget is for these new nanodrug de­ livery systems is, but i am guessing they are expensive. and those of us, who have good iu insurance, will be able to afford them and get that treatment, but the uninsured won't. will we then widen the benefits, the differences, socio­ economic differences that already exists and that are problematic in our society? that's already with existing treatments people have trouble but the more we get fancier, more expensive, new treatments, the more the wealthier have and other people don't have. so, i look forward to your comments and questions and thanks again for including me today. v. legal issues in nanotechnology: new sizesnew issues professor hall: i have pleasure to be here. let me tell you what we are going to try here. what i want to do is to try to link this, and i have a theme. the theme is that the activities you are talking about with the individual speak­ ers, require answers, but they require cross-disciplinary answers, and that as we think about these things, the need for the very specialties; science, ethic, law, medicine, etcetera, to work together is absolutely critical. i am going to briefly talk about this interface. i am going to talk primarily about two major challenges; one is the whole problem of definition, and then i am going to go through three examples to try to put some flesh on these other­ wise theoretical bones of where all of you science types, have really made my life difficult. my world was really pretty nice, nice and simple, we understood it, and you have messed up everything. what we are really trying to do here, is to avoid the gelsinger situation. this is in the gene therapy area, an unfortunate event early on with a patient death, 18-year-old clinical trial subject. it has set back gene therapy by a decade or more, because of the reaction to that. what we need to do, and what the ef­ fort is to take this ethical, legal, social implications of nanotechnology, link 2009] nanotechnology: defining the issues 405 them with the science, medical, technical world, so that we both minimize the risks, but also maximize the benefits. and remember while we are doing this, the public expects us to do this. i am not sure this is optional, the public makes us -and i think they are right, mandates that we do this. there is a tremendous intersection; you have seen some of that. i am not going to go through the details here, but i want you to think about the tremend­ ous number of areas, international trade. we have seen in other areas, for ex­ ample, genetically modified, or foods that international trade becomes an issue here, homeland security. when you think about product uses, you have export users, you have consumers. i also want to mention the nni, the national nanotech initiative, created in the 2000-2001 timeframe, a government cross-agency, operation to promote responsible development and use of nanotechnology. what i want you to think about is the broad range of the organizations within the government that are already linked into this. it cuts across everything. i do mostly fda work but a lot of these is non-fda, but they are linked, and remember there are other as­ pects of regulatory oversight models that are not in this, federal trade com­ mission, ftc. probably the most public problem with nano in europe, if anybody re­ members the product nano magic, it was a bathroom grout that the company made as nano magic, and it ended up sending several dozen people to the hos­ pital. it didn't have anything to do with nano. there wasn't a nano particle in it, it was a solvent. that's ftc issues here in the us, for investors, what you say in your very financing statements. the question; you have heard a couple of speakers say, well, nanotech­ nology or nanoparticles more accurately have been around for a long time. they have actually been here for about 10,000,000,000 years. is this technology even new from our world? can we regulate this using our existing systems? do we need some special testing, some special oversight models, whatever it happens to be? and this is an open question, as to whether our existing systems are ade­ quate? as you think about it, what we are trying to do here is this balance of innovation, and promoting the benefits with management and mitigation of risk. the other question here which remains, is that we have to decide where these decisions are going to be made, either it is going to be at the global level, at national level, state, local? that's all unclear right now, and that can impact us very directly. berkeley, california has passed regulations on nanotechnology research. so you see an example of local activity. you have international stan­ dards setting groups that are also involved here. so we have this open question of where is the regulation going to take place, where should it take place? 406 indiana health law review [vol. 6:385 in the spirit of full disclosure, i was a history major, i took science in high school. i got mostly a's, and declared victory over the sciences and moved on. so when i talk about this stuff, understand the perspective. you have heard a number of people talk about the impact of surface area, the greater exposure of atoms as you get smaller size, etcetera, and the characteristics change with size. asbestos is an example. at some sizes, it's very dangerous, others it's very safe, but understand from the regulatory world that i live in, environmental fda/usda. we have had a mass mindset. we regulate based upon mass, usually in my, the drug world, milligrams-per-kilogram, all of you scientists are making us rethink that entire paradigm, and it may no longer be our traditional measure. if you look at environmental standards, pollution standards, its particles-per­ million, drug dosing or adverse events is a mass-based calculation and that can be very problematic. we also are potentially, emphasize potentially, creating issues that we haven't in my world thought through, and that is at this particle size our traditional views of the blood-brain barrier, the potential barrier, all changed. i did not do the math here, alright, just on that. if you take a cube, 6,000 nanometers in each dimension, and 6,000 nanometers about the length of a red blood cell, just to give you, we give it a mass of one, our total surface area is 216 nanomicron, now i forget the unit, see i told you i am no good at science. if i take that same mass, and i divided into cubes that are 93 nanometers, look what happens, 216*13,000. yet historically my world had looked at these two things as identical. that's our challenge. and we have to understand what those differences are, and how relevant they are. in my world, we live by words. if we say we need some regulatory over­ sight model, that means we have to be able to defme it, and right now, we don't have a consensus on what nanotechnology, or nanoparticle, or nanomedicine, or any of those terms really mean, and that lack of definition is a major prob­ lem, because we can't regulate it until i get to define it, and by the way, you don't want me defining it by myself. the fda has ananotechnologytask-force, created several years ago, they have come up with several reports, they have had public meetings, and they have explicitly refused to define nanotechnology or any of the other terms. i consider that very problematic. there are some scientific descriptions of-i am using the term nanotech­ nology, to accomplish all of these, but they are general, they are nonspecific, and they don't meet the need for a legal definition. rn give you some examples. from nni, here is their definition of nanotechnology; dimensions between ap­ proximately 1 and 100 nanometers. what do lawyers say when they see the word, approximately? it's like blood in the water to a shark. and it also includes things like imaging and measuring. 2009] nanotechnology: defining the issues 407 well, the european commission has a description of nanotechnology, which is not identical, and even on the most simplistic level, the size, 1:100, 1: 100, friends of earth is on record of saying nano is really at 300 nanometers not 100. we just encompass the whole new world, because we don't know is it 100, is it 300, is it 200? and by the way, what's the magic of 100 compared to ·1 01 or 99? and until the scientists can tell me where that line is, we are going to struggle here. take that same cube, if you graph out, i again did not do the math. the cube size with the surface area, you can see if you are up at this part of the curve, these lines don't mean a lot. i might be 4000, 4001 who cares. but once you get down here, it makes a tremendous difference. this is the area where we are applying it in this 100 nanometer approximation, and this curve is what causes people like me to lose sleep, because if we are going to regulate nanotechnology in some form or another, we have to answer this question, of being simplistic. let's assume we have a defmition that says a 100 nanometers. i will give you three scenarios cleverly a, b, c. in a, 90% of the particles are under 100 nanometers. in b, it is 50-50 and, inc, it is 10% or under 90% or over. which one of these meets my definition? and if you tell me it's got to be more than 50%, under a 100 nanometers, what am i going to do? my products have an average size of 101, right? very simplistic example but you understand how this is so important to my world. we also have to remember, we already have products out there that are nanoproducts. here are some examples of them. till date, no one who has iden­ tified and established to a high level of probability, any unique safety issues. now, i am not saying they don't exist, i am saying they haven't been iden­ tified. this gives some people a sense of comfort, other people get nervous about this. are these even new? this is from fda. this is their works, not mine. many approved products, currently on the market with components man­ ufactured the nanoscale. most drugs act at their site at the atomic level, the na­ no level. fda says, we think everything is fine with our regulatory structures. there are number of stakeholders that disagree with that. so if this isn't new or at least had existed before, why the fuss? well, part of it is, this perceived difference, and perception becomes reality. this is the hype that david talked about, and others have talked about. the other, we've just been lucky, or we don't understand the risks we should be looking at. do you have different bioaccumulations of particles based upon size? do we have actually different risks? is this just technophobia? and all of these is going into the debate right now on the ethical, legal, social areas. so let's look at three quick examples of where the science legal regulatory ethical areas intercede in ways that i do not know the answers to. i 408 indiana health law review [vol. 6:385 will start off there. the first one comes from the fda world. drugs and devices are assigned their categories, essentially that drugs act chemically, and devices act physically or mechanically. remember that this differentiation started to come into place in the mid 1930s, when congress passed the 1938 act. if you thinkofwhowas in congress at the time, this means they took their high school science around world war i. science has changed a bit since then. so at the nano-level, the distinction between physics and chemistry disap­ pears. i was having a discussion with a professor of chemical engineering about a particular nanoparticle, and i said, does this work chemically or physically? and she said, that's the dumbest question i have heard in the long time, because there is no difference. my response was, i don't care, congress says there is a difference, and therefore we must determine what that difference is. this has very important practical effects, because they are entirely different regulatory pathways, entirely different toxicology requirements, pharmacokinetics studies, whatever it happens to be. for kyle's view, if it is a "drug", it's three-quarters of the billion plus in 10 years to market. if it's a device at the high risks, it's 50 million in 5 years. slight difference there. that also affects when patients get the benefit. simplistic example of a classic receptor model, right. you've got the re­ ceptors and the neurotransmitter, this maybe a ssri, ssir, excuse me. and i keep using the trumps to define, it binds to the receptor. we want to slow down this or somehow block this from happening. conceptual, there are two ways we can do it. we can get a nanoparticle that attaches itself to the messenger, so that that particle no longer physically fits into the receptor. in my device then, because i am working physically, or i can have my nanoparticle attach itself to the receptor site, so it is filled. is that chemical? we are doing the same thing. one, we are going to say it's chemical. one, we are going to say is a device. one of the examples, kody gave was of a prod­ uct that would attach itself to the tumor cell, you'd then use infrared energy to heat it up and cause thermal, right? is that chemical or is that physical? now what is heat? heat increases molecular activity, right? and with the particles attaching itself to the cell, is that chemical? this distinction between chemistry and physics works at the macro level. if we are talking about tongue depressors, you know, and those kinds of things, but when we get to the nanos­ cale, this merges. and this is a significant issue. this is an example of the type of question we have to answer before the researches, the business people, the 2009] nanotechnology: defining the issues 409 consumer knows how this goes. another example, toxic substances control act. toxic substances con­ trol act or tsca created in the 1970s requires prior notification if you are going to be marketing or distributing a new chemical substance. there maybe testing requirements, etcetera, and the act defines a chemical substance as any organic or inorganic substance of a particular molecular identity, with pick on carbon. carbon has been around for how many years? 10 billion, give or take, a billion here or there, right? is carbon new? and carbon nanoparticles have ex­ isted since the dawn of time, right? so what about a carbon nanotube? there is data, you can debate how good it is, that carbon nanotubes of a particular size may act like asbestos. should we regulate this under tsca? well, we have the same molecular iden­ tity, correct? carbon is carbon is carbon. what's changed here is size and shape. does tsca apply here or not? well, the agency has indicated in a fairly recent, federal register notice, that they view carbon nanotubes as a new chemical substance subject to tsca. the statutory basis for that is questionable, shall we say? the system was created when we didn't think about or didn't know about peculiarities of size and shape. the last example, silver. all those -please i do think of silver as inert, right? we have silver jewelry, silver coins, etc, etc. if the nanoscale is biologi­ cally very active, so "regular silver might term, is inert, nanosilver is biological­ ly very active, and in fact, we've nanosilver products already out there." this is a partial list of them. you can buy bandages with nanosilver, you can buy wash­ ing machine that has filtration system with nanosilver to help get your clothes deodorized and fight germs. so we have these nanosilver products out there. there is data that says nanosilver can pose an environmental risk in aquatic set­ tings. what do you do here? in part, let's think about the cluster of statutory structures and regulatory agencies that are involved. see the cross-functional nature here. remember that fda has a categorical assumption for environmen­ tal impact statements for most of these products, going back 25 or 30 years. so what is our risk here? how do we assess it? does a regulatory system fit with the new understanding and the new products? so what are the key is­ sues that we deal with here? what are the new safety issues if any? our lack of a legal definition, this one bothers me a great deal as you must be able to tell. because if i can't define it, i can't regulate it i can't make you do anything, i 410 indiana heal til law review [vol. 6:385 can't regulate your advertising, for example. we continue to use old systems for these new technologies, and we have this increasing cross-functional interface between the regulatory systems and the science. we have advertising issues, fair trade issues, the ip issues, that emily mentioned, etcetera. so how do we reap the benefits while mitigating the risks, requires this cross-disciplinary work that helps identify the issue, because i certainly don't know most of them, but then requires this linkage in order for us to address it. so that i think ends where we are at this point in time. vi. possffile intellectual property law issues in nanotechnology professor morris: i would like kyle don't want to hide behind the podium because it would engulf me. so, i am going to try to stand at the side here. but what i want to talk about today are some of the intellectual property issues that may arise with some nanotechnology, especially nanotechnology in biotechnology and medicine. so, just a quick overview of the various areas of intellectual property that might be relevant. first of all, relatively few nanotech inventions are actually out on the market now. that's obviously growing and accelerating but very few are really, have been commercialized. nevertheless, we see huge increases in some of the ip issues that come up and a lot of the ip scholars are now com­ menting on nanotechnology. perhaps, most obviously relevant is the field ofpatent law and we already see thousands of patents that are relevant to nanotechnology and they may not necessarily create new or unique issues but maybe will change some of the is­ sues for some of the players that are in the industry, particularly in medicine. our trade secrecy, obviously, is going to be relevant and may actually be the motive-choice for protecting nanotechnology because nanotechnology is difficult to reverse engineer depending on how quickly it evolves, it may not be worth patenting your nanotechnology and for the most part, we don't like this because it doesn't give us the disclosure of the nanotechnology that we would like to have. our trademark, believe it or not, trademark can be relevant to nanotech­ nology. and it's partially this view of nanotechnology is kind of the cutting edge. it's very sexy, right. we have the ipod nano, plus we have this trend of, what they call, the urge to shrink. the smaller it is, the sexier it is, the better it sells. 2009] nanotechnology: 0efjnjng the issues 411 and then finally copyright. not obvious what the copyright issues might be, if any, at this point but perhaps there will be some further down the road and then depending on what happens with the various nanotechnology markets, we may decide that like databases and a variety of other intellectual property assets, that we want to have some sort of sweet generous protection of various types of nanotechnology. so, starting off with patents. as, i think, kyle mentioned there are some 6800 patents already in nanotechnology as of march of this year, as of last month. the patent applications are accelerating. so, every year, we are going to see that number double and triple and in particular, patents are very important to biotech and pharma, to the pharmaceutical industry. so, possibly nanotech­ nology will be of great importance and particularly patents on nanotechs will be important to the biotechnology and pharmaceutical industries and we have al­ ready seen a lot of that in dr. varahramyan's presentation. and of course, there is lots of investment in nanotechnology, a potentially great financial and social return. so, a lot of people are trying to figure out how to internalize those returns and protect their intellectual property assets. proba­ bly, i am guessing the biggest changes we are going to see in patent law are the changes in the players. first of all, as dr. varahramyan and few others have noted, universities are increasingly patent owners, particularly in nanotechnology. i have seen es­ timates where as many as 20% of all nanotechnology patents now come from universities, whereas in other technologies, it's closer to 1% or less. why is that? is that unique to nanotechnology or is it due to some other third factor? well, might be that nanotechnology is still relatively nascent technology and therefore, we are going to see a lot of the patents coming from pure research, which usually takes place in the universities, that hasn't become applied re­ search yet and hasn't moved out into commercial sector. it may be the bayhdole act. bayhdole act was pretty recent and now we are seeing the effects of the bayhdole act in which inventors that enjoy government funding are now allowed to patent their inventions and so maybe nanotech is the first new technology in which we are really starting to see this taking effect. because universities are kind of a relatively new player in the pa­ tent market, or in terms oflicensing patents, it may change the dynamic ofhow patents are used. we will talk more about that in a minute. there is some belief that nano­ technology is very cross-disciplinary and that for those reasons, a patent in one industry maybe entirely applicable in another industry. so, you are going to see a lot more negotiation, not only within industries but between industries and perhaps, some effects from that, some more monopoly-like effects, not only 412 indiana healm law review [vol. 6:385 within one industry but between industries again. is this necessarily new to nanotechnology or to biotechnology and medi­ cine or have we seen this before? well, we have seen this before. we have seen this with nuclear medicine and other areas of technology that have been applied in biotechnology and medicine. so, perhaps this isn't such a new thing that the industries aren't going to be able to deal with. because it's cross-disciplinary, we might see more inventors listed on pa­ tent applications and what kind of difficulties does that create? or what kind of benefits does that create? because co-inventors on a patent are joint owners of that patent they can each separately license the patent to others. so, maybe we will see greater licensing of nanotechnology patents. plus there is the difficulty in valuing nanotechnology patents, in part be­ cause we don't have a great deal of commercialization yet kind of along the lines of what kyle was saying earlier and it's largely government and academic funding at this point, not so much commercial funding and that's perhaps be­ cause of the difficulties as kyle said monetizing the benefits of nanotechnology and particularly nanotechnology ip. so, maybe the start-ups will have a more difficult time attracting funding, in particular venture capital or maybe as the market becomes more familiar, more comfortable with nanotechnology. people will get over those fears and start to be more comfortable investing in nanotechnology. but as kyle said, it's kind of the uncertainty of pioneers. another danger that a lot of people worry about is what can be loosely re­ ferred to as over patenting and the idea is that maybe we will have overlapping patents or patents on things that never should have been patented in the first place. perhaps because nanotechnology is relatively new or at least our under­ standing of it is relatively new. so, it is taking a lot for the uspto to catch up in its expertise. and the uspto actually has made concerted efforts to try to address this problem, in part by creating this whole cross-referencing system in which the nanotechnology in various areas can be cross-referenced against the nanotechnology in other areas and also training their examiners, so that their examiners are more familiar with various issues in nanotechnology. there is some concern that, and this one is again from mark lemley at stanford, that a lot of the early patents on biotechnology or nanotechnology were too broad, that people didn't understand how the nanotechnology was going to be used in the future and therefore, granted these very broad patent rights that can now be leveraged and can actually be used to block further de­ velopments in nanotechnology. 2009] nanotechnology: defining the issues 413 there is also the idea that maybe some of these things just really shouldn't be patented in the first place. as dr. v arahramyan mentioned, nanotechnology has been around for centuries, right. people have been using nanotechnology, whether they knew it or not and that a lot of these things already existed in na­ ture, that they are perhaps the phenomena of nature and we saw this a lot with the genetics patents and genetics, of course, are just a sub-type of nanotechnol­ ogy. there is some idea that like genetics, some of these things perhaps should not be patented because really they are research tools and that doesn't mean that your microscope can't be patented but perhaps some nanotech particle that you have been working on can't be patented because really it doesn't have a function in and of itself except for further research. and then again, this idea of patent overbreadth and especially with the pioneering patents, the early patents ofbio­ technology. they have been too broad, not fully enabled and not fully describ­ ing what it was that was going to be encompassed within the scope of the patent. then finally, in patent now we have a very limited experimentally used defense and given that, nanotechnology is still kind of in its infancy and a lot of people want to continue experimenting and developing nanotechnology, they might have difficulty giving out these pre-existing patents, they have to be li­ censed in order to study a lot of these things. however, unlike computer software, which really is, i think, a lot of scho­ lars have seen, an ill-fit with patent law and copyright law nanotechnology fits pretty fairly within the parameters of what we think of is patent law. it's not necessarily something we can't deal with; we just need to learn more about it perhaps and then we will know exactly how to deal with it under patent law. there is also the possibility now that we have these pioneering inventions in nanotechnology, pioneering patents, that will have the certain explosion of further nanotechnology inventions that basically apply the pioneering inven­ tions and that they might actually be obvious in light of these pioneering inven­ tions and therefore, shouldn't be patented in the fust place. and thereby creating patent thickets and blocking patents, again which create a lot of trans­ action cost and a lot of problems. and perhaps also too many patents and too small patents which create a risk of the tragedy of anti-commons which we saw or at least, we are worried about with regard to genetics. although, it turns out that a lot of people who do research in genetics have been collaborating and sharing information and so it hasn't been as big a problem as we though it might be. there is some debate of over what are equivalents of nanotechnology. be414 indiana health law review [vol. 6:385 cause we don't understand nanotechnology completely, we are not sure what actually are equivalent technologies or older technologies that might have used some sort of macro or micro level technology can now replace certain parts of their functioning with nanotechnology and is that just an equivalent use. in patent law, we have seen what many believe to be the death of what we call the doctrine of equivalents and the certain death of the reverse doctrine of equivalents but maybe with nanotechnology we will see a resurgence in the use of the doctrine of equivalents as people get more familiar with the technol­ ogy. then fmally, there is a difficulty in detecting infringement, in part because the particles are so small, so how do you know when someone is actually in­ fringing your nanotech patent and there is this idea that as dr. orentlicher men­ tioned nanotech particles are very small, very light, but very durable. so you run the risk of what we call passive transfer. that someone may pick up on your nanotech particle, your nanotech patent, without even knowing it and how are you supposed police that if they don't even know that they are carrying around your nanotech particle. and then there is some question to also whether or not this is even a prob­ lem because we could have individualized medicine or other types of individua­ lized uses of nanotechnology that aren't as much at risk for infringement. and so far we really haven't seen many cases in courts, a lot of this is just conjec­ ture, so the effects have yet to be seen in the courts. so, how do we solve the potential problem for overj)atenting? well, may­ be, it will solve itself. because a lot of this is government funded, we might see some government interventions, and compulsory licensing, cross-licensing or some sort of hatch-waxman like legislation that enables people to use patented technology more easily, more quickly than they would otherwise. again because the universities are such a big player, they may affect the way this alleged over patenting actually works out. with universities, we have this academic tradition of collaboration, sharing of information, publication. so, we might have some barring disclosures, such that patents can't be granted at all, or even defensive publication, where our university researchers may say, i don't want anybody patenting this, i don't want anybody having exclusive rights to it. therefore, i am going to publish my information about it so that no one can patent it. then third, we could have third party. standards setting organizations that we see in other industries that may help coordinate the nanotechnology, but also help cross-license it and share it and make sure people are collaborating with one another. 2009] nanotechnology: defining ti:1e issues 415 as i was thinking about this, i was sitting at my office, kind of free asso­ ciating about how nanotechnology relates to patent world in particular. and i started to think about the pharmaceutical industry. historically, the pharmaceut­ ical industry has been very depended on patents, in part because drugs are con­ sidered just kind of monolithic or unitary invention and therefore you don't have to coordinate all these other patents in order to produce your pharmaceuti­ cal agent. but nanotechnology may change that, in part by bringing these new drug delivery systems that dr. orentlicher talked about and dr. v arahramyan talked about and that in order to take advantage of these new drug delivery sys­ tems, you essentially have to combine them with your drug, with you pharma­ ceutical agent, that can't be separate the way, an intravenous needle and the drug that you actually inject through the needle could be separate. these actual­ ly but have to be bundled together and sold together and therefore, you may see the pharmaceutical industry having to license patents for probably the first time in it's life. so, just a quick, i think, others have shown you pictures of this, but just a quick review of some of the differences in drug delivery that we may see in the pharmaceutical industry, these are nanoshells attacking a cancer cell and these little green things here are antibodies. this colorful thing here is what's called a liposome where you· have basically fatty acids on the outside and then some sort of aqueous solution on the inside in which you can hide drugs, right, not from the airport, but in terms of the cancer cell that you are targeting. and then these are micelles, this fussy guy here is a micelle which is basi­ cally a liposome turned inside out. so that the fatty acids are on the inside, then these are kind of hydrophilic extensions. again, useful ways of introducing drugs into cells. so, we may see more cross-licensing, more defensive patenting or maybe less aggressive enforcement of patents in the pharmaceutical industry. we could maybe see a chance to evergreen pharmaceutical patents simply by add­ ing these drug deliveiy systems onto the drugs and then trying tore-patent them perhaps. and then this is kind of my conspiracy theory conjecture here, you might even see attempts by the pharmaceutical industry to stifle nanotechnology because it threatens their existing business, i don't know, i mean people make a lot of this kind of conjectures about the oil industry, you can take your guess as in the pharmaceutical industry. alright, trade secrecy and i will go through this quickly. trade secrecy obviously attracted for nanotechnology in part because reverse engineering is difficult, but security is also difficult, again because of passive transfer and oth­ er things like that. in part because universities are such a big player in nano­ technology, we may see more collaboration, more publication and therefore, more difficulty in keeping nanotechnology a trade secret, and do we want trade 416 indiana health law review [vol. 6:385 secrecy in nanotechnology at all? well, generally trade secrecy is considered bad because you are not shar­ ing the information in disclosure. again, this field is kind of in its infancy, it's a cross-disciplinary field so trade secrecy might be difficult anyway and would certainly be harmful to further development of the field. then again, in particu­ lar with biotechnology and medicine where there is a strong public interest ob­ viously in open access to nanotechnology. and so, we need to look for ways to encourage patenting or better yet open licensing allowing this new nanotech­ nology. alright, i promise you, i will cover trademarks, nobody has thought the trademarks would apply to nanotechnology but they in fact do. to some extent nano is a very popular marketing device. again, it's the urge to shrink, it's very sexy. and there has been a race to register trademarks that have a nano in their name somewhere. and the question is, as we actually have things that are of the nano size. does the word nano become arbitrary? right, the ipod nano is not nanometers in size, or does it become descriptive, when we actually talk about real nano particles. and may be there is some question about truth and advertising and this is where you might see some of the moral concerns or social concerns about nano­ technology combing back to bite people. if you put nano in your name, people might be more likely to buy it or they might be less likely to buy it. we have seen a lot of this back actually in terms of organic foods, genetically modified foods, the frankenfood as dr. orentlicher mentioned. alright, so is the word nano a boon or bum? well we will see that in trademarks. especially in biotechnology and medicine because branding and trademarks are becoming increasingly frequent in those fields. and then finally copyright and i swear this is my last slide. it's difficult again to foresee how copyright might apply the nanotechnology, but you can use your imaginations and actually for those law students that are out in the audience, i challenge you to think of how to leverage copyright law in nanotechnology, your law firms will love you because you figured out new claims that you can make against other people under copyright law and not just patent law and trade secrecy. possibly with regard to software for nanotechnology we might have some copyright issues. we might have issues with regard to nanotechnological mask work, something similar to the semiconductor chip protection act. which is more or less obsolete now because it's so difficult to reverse engineer semi­ conductor chips. and then there are some possibility and this isn't related obviously to bio­ tech and medicine that people will start using nanotechnology to protect their 2009] nanotechnology: defining the issues 417 copyrighted works, kind of in lines ofdigital rights management, but instead of having it on your machine on your computer or you vcr player, you will actually have it on the dvd itself: possibly. thank you very much. ncaa student-athlete health care: antitrust concerns regarding the insurance coverage certification requirement ncaa student-athlete health care: antitrust concerns regarding the insurance coverage certification requirement kyle r. wood 1 i. introduction......................................562 ii. the ncaa, athletic conferences, member institutions, and the student-athletes .......... 566 a. the ncaa. ............................ ..... 566 1. the early years ...................... ..... 567 2. the modern era .............................. 569 3. the ncaa today. ..................... ..... 571 b. athletic conferences. ................... ...... 574 c. member institutions............. ............. 578 d. student-athletes ................................ 581 1. financial aid ........................ ...... 582 2. student-athlete groups ........................ 583 a. the national collegiate players association......584 b. the student-athlete advisory committee ......... 586 iii. ncaa finances .................................. 587 a. ncaa revenues and expenses of division i intercollegiate athletics programs report 2004-2010 and discussion of the bowl championship series revenues ............................. ..... 587 b. ncaa membership report 2009-2010 . ........... 593 c. the "scholarship shortfall" problem ............ 596 iv. the current state of ncaa legal affairs ........... 598 a. recent ncaa regulatory action ............... 598 b. antitrust law .............................. 601 1. ncaa. v. board of regents of the university of oklahoma and university of georgia athletic association .......................... ..... 602 2. the ncaa as a monopsony............. ..... 604 3. the procompetitive presumption and the studentathlete labor market .................. ..... 606 a. the procompetitive presumption ............ 606 b. student-athlete labor market. .............. 609 j.d., indiana university robert h. mckinney school of law, 2013. b.a., indiana university bloomington, 2007. indiana health law review c. public policy concerns .................. ..... 615 v. assessing the merits of ncaa health care insurance reform ........................... ..... 616 vi. conclusion .................................. ..... 626 i. introduction in 2005, the national collegiate athletic association ("ncaa" or the "association") promulgated a condition and obligation of membership that all member institutions "must certify insurance coverage for medical expenses resulting from athletically related injuries sustained [by student-athletes] while participating in a covered event."2, 3 this rule permits that the insurance coverage may be provided through three possible sources: a policy held by the student-athletes parent(s) or guardian(s), a policy held by the student-athlete personally, or through the institution's insurance program.4 the amount of coverage the institutions must certify shall be equal to or greater than the deductible amount of the catastrophic injury insurance provided by the ncaa.5 that deductible amount is 2 nat'l collegiate athletic ass'n, 2011-2012 ncaa division i manual § 3.2.4.8, at 10 (2011), available at http://www. ncaapublications.com/p-4224-20 11-20 12-ncaa-division-i-manualaugust2011.aspx (last visited mar. 1, 2013) [hereinafter division i manual]. 3 division i manual, supra note 1, § 3.2.4.8.3, at 10-11 ("covered event. a covered event includes the following: (a) any intercollegiate sports activity, including team travel, competition, practices and conditioning sessions during the playing season (as defined in bylaw 17.1.1); (b) an ncaa-sanctioned competition in which the insured person is an official competitor; or (c) practice and conditioning sessions that are authorized, organized or directly supervised by athletics department personnel at the member institution other than during the playing season. such sessions must occur on campus or at approved offcampus facilities as part of an intercollegiate athletics activity. for insured student-athletes or prospective student-athletes who compete in individual sports, off-campus intercollegiate athletics activities must be authorized by athletics department personnel at the participating school and take place at approved locations."). 4 division i manual, supra note 1, § 3.2.4.8.1, at 10. 5id. 562 vol. 10:2 ncaa strudent-athletf health care currently $75,000 or $90,000, depending upon whether the institution participates in the ncaa group basic accident medical program.6 in essence, a student-athlete must have health care insurance up to at least $75,000 or $90,000 for athletic-related injuries prior to participation in an ncaa sponsored event. ncaa member institutions may voluntarily provide health care insurance for their studentathletes, but there is no requirement to do so. despite this series of requirements, the rule in practice does not require that student-athletes have health care insurance that will actually cover any medical expenses incurred during participation in a "covered event."7 the overview of legislation accompanying bylaw 3.2.4.8 specifically states that insurance coverage that is subject to out-of-state coverage limitations would satisfy the requirements for certification even if the student-athlete attends an institution in a state in which the insurance coverage is void.8 this is only one example of how, notwithstanding a series of rules intended to ensure the health and safety of student-athletes, those young adults who represent the institutions through athletic participation may not be adequately protected. other potential roadblocks to adequate coverage include policy exceptions for injuries sustained during collegiate or 6 nat'1 collegiate athletic ass'n., catastrophic injury insurance program benefit summary for the period 8/1/12 through 7/31/13, ncaa (jul. 30, 2012), http://www.ncaa.org/wps/wcm/connect/public/ncaal ncaa+insurance+programs/student+athlete+insurance+programs/ catastrophic+insurance+program; ncaa group insurance programs, ncaa, http://www.ncaainsurance.com/ (last visited mar. 1, 2013). 7 kristina peterson, college athletes stuck with the bill after injuries, n.y. times, jul. 16, 2009, at al, available at http://www. nytimes.com/2009/07/16/sports/16athletes.html (last visited mar. 1, 2013). 8 id. (follow hyperlink "the n.c.a.a. explains to colleges how to comply with n.c.a.a. health insurance rules" to the ncaa overview of legislation; scroll to "question 9": "[question:] if a student-athlete has coverage through an hmo that' s only valid in the state they live in, does that satisfy the requirement if they are in a school outside that state? [answer:] yes. however, again it should be disclosed to the parent/guardian that they are responsible for any costs not paid by insurance if the university does not cover those costs."). 2013 563 indiana health law review intercollegiate athletic participation, 9 diagnosis of the ailment as an illness rather than an injury,' 0 and the cost concerns of the individual student-athlete.1 without health care insurance provided by the member institution, there is a substantial burden for an inexperienced student-athlete to overcome in order to be assured any injury suffered during athletic participation will not leave them faced with significant medical debt.12 this burden has led several 9 my alma mater, indiana university, is one of several universities that excepts coverage for injuries sustained during college or intercollegiate sports participation from the basic student health care insurance offered by the university. see 2012-2013 indiana university, student health insurance plan for indiana university undergraduate and graduate students (2012), available at http://www.indiana.edul-uhrs/benefits/pubs/books/student-voluntary broch_201213.pdf (insurance underwritten by aetna life insurance company). see also peterson, supra note 6 (follow hyperlink "student health care policies from suny buffalo and florida state showing that the default school plans exclude varsity sports injuries") (showing both policies also underwritten by aetna life insurance company). 10 peterson, supra note 6 (presenting the story of erin knauer, colgate university student-athlete who sustained injury to her back and legs during training for the crew team. "her symptoms were later diagnosed as postviral myositis, a muscular inflammation that can cause weakness and pain. because colgate officials deemed the condition an illness not an athletic injury they said financial responsibility [for approximately $80,000 in medical bills] fell to knauer."). 11 it should be noted that while recent changes under the patient protection and affordable care act allow individuals to remain covered under insurance policies held by their legal guardian(s) until they reach twenty-six years old, there is no certainty that the policy held by a student-athlete's guardian(s) will qualify for certification or adequately cover the health care needs of the student-athlete, assuming of course their guardian(s) in fact holds health care insurance. these studentathletes may be required to purchase policies for themselves requiring the student-athlete or their guardian(s) to pay a substantial monthly fee. the student health insurance offered by indiana university which excludes college and intercollegiate sports injuries costs $1,999.00 annually for a $1000.00 deductible. see voluntary student health insurance 2012-2013, indiana.edu, http://www.indiana.edul-uhrs/ benefits/studentvoluntary2012-13.html (last visited mar. 1, 2013). 12 see jacob dirr, college athletes: winners or losers when it comes to health insurance?, insurancequotes.com, http://www. insurancequotes.com/health-insurance-college-athletes/ (last visited mar. 1, 2013) (explaining how between the years of 1988-89 through 564 vol. 10:2 ncaa student-athleti; iii altll car5 individuals and organizations to call for the ncaa to mandate that its member institutions provide health care insurance coverage for all student-athletes. 13 this note will set forth and analyze concerns facing the ncaa specifically related to health care coverage of studentathletes for athletically-related injuries. those concerns implicate numerous public policy issues and potential antitrust liability. initially, section ii will examine the relationships between the ncaa, athletic conferences, member institutions, and the student-athletes (including active student-athlete representational groups), addressing the stated intents of the parties where applicable. section iii reviews the financial situations of the ncaa, member conferences and member institutions; specifically, brief audits of the ncaa revenue report for 2004-2010 and the ncaa membership report for 2009-2010 will be conducted, along with a review of recent financial developments for the membership, followed by an explanation of the "scholarship shortfall" problem. section iv analyzes recent attempts at regulatory changes by the ncaa, ncaa antitrust jurisprudence including the recent development of studentathletes as a relevant labor market, and the increasing volume of public policy concerns over the association's governance. section v assesses the merits of an antitrust challenge to the current ncaa bylaws regarding studentathlete health care coverage certification and voluntary coverage by member institutions, and the ncaa revenue 2003-04, there were reported more than 182,000 student-athlete injuries sustained during competition and practice in fifteen major sports, citing data published in the journal of athletic training). 13 press release, nat'l college players ass'n, california and indiana lawmakers to push athletes bill of rights (feb. 12, 2012), available at http://ncpanow.org/releasesadvisories?id=0020 (ncpa model legislation seeks to mandate institutions with financial resources to provide for all student-athlete medical costs); white v. ncaa, no. cvo6-0999 vbf (manx) (c.d. cal. 2008) (showing stipulation and agreement of settlement) (including plaintiffs' claim for health care costs in complaint); of peterson, supra note 6 (" 'the only way to increase coverage would be to make it mandatory,' " said joe d'antonio, the chairman of the n.c.a.a.'s legislative council and associate commissioner of the big east conference. 'it could be too demanding financially on some of our institutions.' "). 2013 565 indiana health law review distribution formula. section v also suggests measures for the ncaa and its membership to avoid potential litigation and possible financial strategies to fund the most accessible comprehensive health care program for student-athletes. ii. the ncaa, athletic conferences, member institutions, and the student-athletes it is a common misconception that ncaa regulations govern all of the structural aspects and decision-making processes of the athletic conferences and member institutions. to an unversed observer, conferences appear much like divisions in professional sporting leagues. this is not the case. while there is some overlapping of governance and indeed a hierarchy of command, both the athletic conferences and member institutions are left with a wide range of discretion in numerous facets of athletic operations. the most obvious difference is that the individual contract rights of the ncaa, the athletic conferences and the member institutions are restricted far less in relation to one another than the contract rights of similarly situated parties in professional sports leagues (imagine if you will the atlanta hawks contracting to move from the southeast division to the atlantic division of the eastern conference in the nba, a move similar to the en masse conference realignments taking place in modern college sports). beyond the respective contract rights of the parties, each have their own economic structures and make decisions based on individualized goals that may or may not conform with the goals of the other parties to a greater extent than is typical of professional sports leagues. a. the nc4a [t]he national collegiate athletic association[ i is a voluntary, non-profit standardsetting association that promulgates the rules of competition for and operates annual national championships in [231 sports across three divisions. its membership includes 566 vol. 10:2 ncaa student-athlith health care over 1,200 educational institutions, athletic conferences, and related organizations. it promulgates rules of play, recruiting, length of season, amateurism, and equipment regulations, operates championships and maintains intercollegiate athletics records. 14 the ncaa consists of over 440,000 student-athletes who compete in eighty-nine national championships. 15, 16 1. the early years in the beginning, college football was more reminiscent of ancient roman gladiator games than the comparably docile contest it is today. between the years 1890-1905, football game-related injuries resulted in the deaths of 330 players.17 with national concern over the brutal nature of the sport generating an overwhelming call for reform or the total abolition of the sport, president theodore roosevelt convened collegiate athletic leaders to two white house conferences to discuss reform in 1905.18 later that same 14 in re ncaa i-a walk-on football players litigation, 398 f. supp. 2d 1144, 1146 (w.d. wash. 2005) (since publication, the ncaa has increased the operation of national championships from 22 sports to 23). see nat'l collegiate athletic ass'n, 2009-10 ncaa membership report 36 (2010) available at http://catalog.proemags. com/publication/oaffe96d#/oaffe96d/1 (last visited mar. 1, 2013) [hereinafter membership report]. 15 nat'l collegiate athletic ass'n, 1981-82 2010-11 ncaa sports sponsorship and participation rates report 5 (2011), available at http://ncaapublications.om/p-4243-student-athlete-participation-198182-2010-11-ncaa-sports-sponsorship-and-participation-rates-report.aspx (last visited mar. 1, 2013) [hereinafter sports sponsorship and participation rates report]. 16 who we are, ncaa, http://ncaa.org/wps/wcm/connect/public/ ncaa/about+the+ncaa/who+we+are+landing+page (last visited mar. 1, 2013). 17 daniel e. lazaroff, the ncaa in its second century: defender of amateurism or antitrust recidivist?, 86 or. l. rev. 329, 332 (2007) (citing andrew zimbalist, unpaid professionals 8 (1999) [hereinafter zimbalist]). 18 history, ncaa, http://www.ncaa.org/wps/wcm/connect/public/ ncaa/about+the+ncaa/history (last visited mar. 1, 2013). 5672013 indiana health law review year, chancellor henry m. maccracken of new york university convened a meeting of thirteen institutions to ratify the needed reformation of college football playing rules with a focus on the health and safety of studentathletes. at a subsequent meeting held on december 28, 1905 in new york city, less than a month after chancellor maccracken's initial meeting, sixty-two colleges and universities became charter members of the intercollegiate athletic association of the united states (iaaus).19 on march 31, 1906, the iaaus was officially constituted. it would operate under that name until 1910, when the association took its present name, the national collegiate athletic association. 20 from its formation, the overarching purpose of ncaa regulations was to protect the health and safety of student-athletes. for the first fifteen years, the ncaa was almost exclusively a discussion group and rulemaking body. while football violence was the initial trigger for the creation of the ncaa, early ncaa rules turned their focus strongly toward regulations "relating to amateurism and eligibility rules."21 these early amateurism and eligibility rules banned all institutions from awarding any scholarships or financial aid based on athletic rather than academic ability.2 2 the ncaa officially defined "amateur athlete" in 1916 as "one who participates in competitive physical sports only for the pleasure, and the physical, mental, moral, and social benefits directly derived therefrom."23 beyond reforming the rules of college football and defining standards of eligibility, the ncaa did little more during this initial period. the ncaa expanded its role in college sports in 1921, holding the first ncaa national championship: the national collegiate track and field championships. the 19 id. 20 id. 21 lazaroff, supra note 16, at 332 (citing allen l. sack & ellen j. staurowsky, college athletes for hire 33 (1998) [hereinafter sack]). 22 id. 23 id. (citing nat'l collegiate athletic ass'n, proceedings of the eleventh annual convention 118 (1916)). 568 vol. 10:2 ncaa student-athletr health care following year, the ncaa altered slightly its definition of "amateur athlete" to "one who engages in sport solely for the physical, mental, or social benefits he derives therefrom, and to whom the sport is nothing more than an avocation."24 this definition reaffirmed the restrictions barring athletes from receiving financial aid based on athletic abilities. over the next three decades, the ncaa expanded further, creating more rules committees and forming additional national championships (most notably, the men's basketball championship in 1939).25 yet, with the tremendous growth in the popularity of college football it became exceedingly difficult to enforce the ncaa amateur code. 26 the ncaa had no enforcement powers. policing of the regulations promulgated by the ncaa was left to the conferences and member institutions to self-enforce. 27 "increasingly, it had become evident that reliance upon voluntary compliance by ncaa member institutions would not solve the myriad problems created by the dramatic expansion of intercollegiate athletics and the [financial] opportunities such growth presented."28 absent a credible enforcement agency, the financial rewards associated with athletic success presented an enticement that led too many institutions and individuals to ignore ncaa regulations with tremendous regularity.29 voluntary compliance was an illusory agreement among the membership. 2. the modern era in 1948, the ncaa adopted the "sanity code" in an attempt to effectuate compliance with its rules and 24 id. (citing nat'l collegiate athletic ass'n, proceedings of the seventeenth annual convention (1922)). 25 history, supra note 17. 26 lazaroff, supra note 16, at 332 (citing arthur a. fleisher iii et al., the national collegiate athletic association: a study in cartel behavior 42-45 (1992) [hereinafter fleisher]) (documenting the growth of college sports and its commercialization during the "golden age" for college football (i.e., 1920s-1950s))). 27 id. (citing sack, supra note 20, at 35). 28 id. 29 id 5692013 indiana health law review regulations. 30 the sanity code established guidelines for recruiting and financial aid. the sanity code restricted the amount and type of financial aid student-athletes were eligible to receive by requiring that student-athlete "recipients utilize the 'normal channels' that other students were compelled to follow. aid was restricted to tuition and fees and could not be awarded based on athletic ability."31 the sanity code failed to curb abuses. the potential for economic gain remained too great. the commercial appeal of college football led to a sustained increase in the number of postseason contests and the new medium of television presented many issues which had never before been addressed by any industry. in response to the complexity of problems plaguing enforcement of its rules and regulations, the ncaa appointed walter byers as its first executive director in 1951 and established a national headquarters in kansas city, missouri in 1952. 32 over the course of the 1950s, the amateurism ideal evolved drastically. the ncaa adopted new regulations governing financial aid to student-athletes that replaced the original amateurism ideal. the association abandoned its restriction that limited the basis of grant-in-aid awards solely to financial need or academic ability and "financial inducements could be used to entice gifted athletes to participate in sports . . . ."33 in 1956, the ncaa began to permit full grants-in-aid based on athletic participation. the full grants-in-aid were calculated to include tuition, fees, room and board, books, and $15 per month for "laundry money."34 yet, despite the liberalization of financial aid regulations, opportunities for generating high volume revenues from successful athletic programs continue to incentivize noncompliance. 3 5 today, the temptations for institutions, players, and fans to ignore ncaa rules and 30 id. (citing fleisher, supra note 25, at 47). 31 id. at 333. 32 history, supra note 17. 33 lazaroff, supra note 16, at 333-34. 34 lazaroff (referencing zimbalist), supra note 16, at 23-24. 35 lazaroff, supra note 16, at 334. 570 vol. 10:2 ncaa stjdent-athlete health care regulations is greater than ever before, continuing to demonstrate the importance of regulatory enforcement by the ncaa if the amateurism model of collegiate sports is to continue. ncaa regulations serve a legitimate function when they repel excessive commercialization and other potential distractions that may interfere with the primary purpose for which student-athletes are attending the institutions: their education. 3. the ncaa today current ncaa regulations address a wide array of issues from rules for game play, defining the playing and practice season, employment of athletics personnel, studentathlete academic and amateurism eligibility standards, student-athlete benefits, employment of agents, and participation in professional league drafts, to highlight only a few. current rules cap the amount of financial aid awards student-athletes can receive at "cost-of-attendance that normally is incurred by students enrolled in a comparable program at that institution," regardless of the source from which the financial aid is provided. 36 the ncaa establishes limits on the number of athletics-based grants-in-aid each school may award. 37 student-athletes may not be represented by an agent. 38 student-athletes may not use their athletic skills, either directly or indirectly, for pay in any form in that sport, nor may the student-athlete sign any contract or commitment to play professional sports, even should the contract postpone its effective date until after that athlete has exhausted collegiate eligibility. 39 compensation that student-athletes may earn from nonathletic employment is regulated heavily as well. "compensation may be paid to a student-athlete . .. [only for work actually performed . . . [alt a rate commensurate with the going rate in that locality for similar services." 40 36 division i manual, supra note 1, § 15.01.6, at 192. 37 division i manual, supra note 1, § 15.01.7, at 192. 38 division i manual, supra note 1, § 12.3.1, at 70. 39 division i ianual, supra note 1, § 12.1.2, at 62-63. 40 division imanual, supra note 1, § 12.4.1, at 71. 5712013 indiana health law review student-athletes cannot receive any compensation related to "the publicity, reputation, fame or personal following that he or she has obtained because of athletics ability."41 this denies student-athletes the opportunity to endorse any products even if that endorsement is not directly related to their participation in ncaa athletics. 42 "it is not permissible for a donor to contribute funds to finance a scholarship or grant-in-aid for a particular studentathlete."43 the receipt of any prohibited compensation (improper benefits) renders that student-athlete ineligible for ncaa competition. 44 "the ncaa's core purpose is to govern competition in a fair, safe, equitable and sportsmanlike manner, and to integrate intercollegiate athletics into higher education so that the educational experience of the student-athlete is paramount."45 the ncaa lists seven core values on its website ncaa.org: * the collegiate model of athletics in which students participate as an avocation, balancing their academic, social and athletics experiences. * the highest levels of integrity and sportsmanship. 41 division i manual, supra note 1, § 12.4.1.1, at 71. 42 see bloom v. nat'l collegiate athletic ass'n, 93 p.3d 621 (colo. ct. app. 2004) (jeremy bloom gained fame as an olympic freestyle mogul skier prior to enrollment at colorado university, where he participated in intercollegiate football. due to his success as a skier, bloom was offered numerous paid entertainment and endorsement opportunities. the ncaa denied bloom's request for a waiver of the ncaa restriction on student-athlete endorsement and media activities. the court denied bloom's request for a preliminary injunction against the ncaa regulation, finding that he did not have a constitutionally protectable property interest in ncaa athletic participation and that the ncaa had not arbitrarily applied its restriction in denying bloom's request for a waiver.). 43 division i manual, supra note 1, § 15.01.4, at 191. 44 division i manual, supra note 1, § 15.01.2, at 191. 45 ncaa, linkedin.com, http://www.linkedin.com/company/ncaa (last visited mar. 1, 2013). 572 vol. 10:2 ncaa student-athlete health care * the pursuit of excellence in both academics and athletics. * the supporting role that intercollegiate athletics plays in the higher education mission and in enhancing the sense of community and strengthening the identity of member institutions. * an inclusive culture that fosters equitable participation for studentathletes and career opportunities for coaches and administrators from diverse backgrounds. * respect for institutional autonomy and philosophical differences. * presidential leadership of intercollegiate athletics at the campus, conference and national levels. 46 these goals emphasize the important role of education in ncaa athletics. there is also specific mention of the goal to preserve institutional independent decision-making and leadership. yet, there is an obvious absence of any attention to student-athlete well-being. one might draw the conclusion from the stated core values of the association that the ncaa aims to operate as an association of multiple educational entities, attempting not to interfere with the independent decision making of those entities as much as possible. so long as the institutions equally encourage their student-athletes to succeed academically and athletically, do not discriminate, and do not pay the student-athletes as 46 core values, ncaa (june 29, 2010), http://ncaa.org/wps/wcm/ connect/public/ncaa/about+the+ncaa/who+we+are/core+values+landing+ page. see also, powerpoint: division i welcome to the world of compliance, 2012 ncaa regional rules seminars, http://www. google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0cdkq fjab&url=http%3a%2f%2ffs.ncaa.org%2fdocs%2fregionalseminars %2f2012%2fpowerpoint%2520presentations%2fdivision%25201%2f division%25201%252owelcome%2520to%2520the%2520world%2520of %2520compliance.ppt&ei=tx4-ubdnkosvyggbn4bo&usg=afqjcnes njbye7ypvoyruezavtblpmgyg&sig2=ospfhuz6x2nsfs2lpf682w& bvm=bv.43287494,d.awe (scroll to slide twelve entitled "ncaa core values cont'd.'). 5732013 indiana health law review professionals, there is no further duty to be met by the membership regarding the student-athletes. b. athletic conferences as of 2010, there are 137 active athletic conferences supporting ncaa sponsored athletics across three divisions.47 by contrast, in 1950 there were eleven active athletic conferences.48 the modern trend in ncaa athletics demonstrates that the value of conference membership continues to increase dramatically for the individual member institutions as well as the ncaa as a whole. "independent" member institutions, forsaking conference membership for greater contractual and financial autonomy, have decreased to virtual nonexistence save some notable exceptions, and even in those cases, independence is generally retained on a sport-specific basis. 49 the conference-based model has proved to provide greater financial security and potential for growth, especially in division i. ncaa division i revenue distributions are determined chiefly based on the cumulative economic statistics and the performance in the men's basketball championship of the member institutions in affiliated conferences.50 it will be important to observe what ultimately results from the extensive conference realignments currently taking place. 51 with dozens of teams abandoning traditional rivalries and geographical proximity to their conference foes for more lucrative competitive and economic scenarios, the driving force behind the realignment movement appears to be the potential to increase athletics revenue. it is likely 47 membership report, supra note 13, at 5. 48 _d. 49 for example, army, navy, brigham young university, and notre dame currently remain independent in the top-tier of college football. see college football teams, espn.com, http://espn.go.com/ college-football/teams (last visited mar. 1, 2013). 50 see discussion infra part ji.b. (internal cross-reference) 51 conference realignment, collegesportsinfo.com, http:// collegesportsinfo.com/conference-realignment-grid/ (last visited mar. 1, 2013). 574 vol. 10:2 ncaa student-athlete health care that as the conference alignments begin to settle out over the next few years that there will be a corresponding proliferation in the number of conference-oriented television networks, similar to the highly successful big ten network that was launched in late 2007.52, 53 projected figures show that the big ten network will generate approximately $2.8 billion for basketball and football broadcast rights over the twenty-five year period from 2007-08 through 2031-32.54 for example, in 2010-11, the network paid the university of illinois $7.9 million for those broadcast rights.55 that was a twenty one-percent increase over the previous year's figures.5 6 these results demonstrate that it is more than likely financially irresponsible for a conference with viewership demand not to form a broadcast network. beyond the development of conference television broadcast networks, it will be important to observe other revenue sharing models employed by the newly arranged conferences. revenue sharing plays a vital role in conference prosperity. in the words of larry scott, commission of the pacific 12 conference, "[e]qual revenue sharing is the hallmark of any stable conference."57 as we move forward in the new era of conference realignment, expanded revenue sharing will offer the potential to alter the state of the game for the better. most notably, it will be 52 big ten history, bigten.org, http://www.bigten.org/trads/bigl0trads.html (last visited mar. 1, 2013). 53 other conferences have recently entered into broadcast agreements/launched networks. see big xii digital network, big12sports.com, http://www.bigl2sports.com/viewarticle.dbml?db_ oemid=10410&atclid=1522821 (last visited mar. 1, 2013). 54 kristi dosh, television contract breakdown, the business of college sports (may 5, 2012), http://businessofcollegesports.com/ 2011/05/05/televison-contract-breakdown/. 56 adam rittenberg, big ten schools see increased revenue, espn.com (jul. 19, 2011, 1:00 pm), http://espn.go.com/blog/bigten/post/ lid/29356/big-ten-schools-see-increased-revenue. 56 id. 57 kirk bohls, pac-12 coamhssioner says era of super conference fast approaching, but his league won't be the ca use, austin american statesmen (sept. 4, 2011, 10:28 pm), http://www.statesman.com/sports/collegefootbal/pac12-commissioner-saysera-of-super-conference-1820070.html. 2013 575 indiana health law review important to focus on individual member institutions' apparel licensing and gate receipt revenues. collegiate apparel licensing currently generates around $4.3 billion annually. 58 conferences share some licensing revenue; however the amounts contributed for shared revenue distributions account for very little. 59 furthermore, 155 member institutions are clients of the collegiate licensing company ("clc"), a company that provides clients with brand development, management, and protection. 60 clc does not possess an exclusive license of its member institutions' trademarks, and a review of their website appears to indicate that revenues are not equally distributed among the clients, but rather that the member institution clients receive actual distributions of revenue generated by their particular products. 61 it appears that the vast majority of apparel licensing revenues are retained by the individual institutions. this can create enormous disparities between conference members due to the greater popularity and marketability of some members in comparison to others. for example, the university of michigan received nearly $1.5 million in royalties from apparel sales during the first quarter of fiscal year 2008.62 in comparison, the university of iowa received $1.8 million 58 kristi dosh, cracking down on counterfeit apparel, espn.com (jan. 8, 2012 10:10 am), http://espn.go.com/blog/sec/post/_/id/36685/ crackingdown-on-counterfeit-apparel-2. 59 tim griffin, how the big 12 teams rank in revenue-sharing funds, espn.com (may 26, 2009, 10:46 am), http://espn.go.com/blog/ bigl2/post_/id/2094/how-the-big-12-teams-rank-in-revenue-sharing-funds (showing in 2007-08, big 12 member institution licensing revenue accounts for only $434,623 of the $103.1 million contributed to the conference revenue sharing funds). 60 clients, collegiate licensing company, http://www.clc.com/ clients.aspx (last visited mar. 1, 2013). 61 clc services, collegiate licensing company, http://www.clc. com/clc-services.aspx (last visited mar. 1, 2013). 62 lara zade, despite rough season and rougher economy, 'u' apparel sales steady, the michigan daily (nov. 13, 2008), http://www.michigandaily.com/content/2008-11-14/even-rough-seasonand-economy-michigan-apparel-sales-are-steady. 576 vol. 10:2 ncaa student-athlete health care in royalties from apparel sales during the entire 2008 fiscal year.63 gate receipts generate a sizable portion of athletics revenue as well. according to the knight commission, ticket sales account for about twenty eight-percent of generated revenue by football bowl subdivision institution athletic departments.64 to use the big ten as an example again, in 2009-10, gate receipts accounted for over $263 million, not accounting for northwestern, a private institution not subject to open records requests. 65 the big ten is the only conference that currently engages in revenue sharing of gate receipts. 66 this practice greatly helps to improve the quality of athletic department services among the member institutions and helps to reduce the disparity that exists based upon the various levels of success of revenue generating sports, especially football. 67 63 ariana witt, ui trademark revenue increases, goes to athletics, the daily iowan (apr. 18, 2011, 7:20 am), http://www. dailyiowan.com/2011/04/18/metro/22909.html. 64 college sports 101 chapter 3: revenue, knightcommission.org, http://knightcommission.org/index.php?option= com content&view=article&id=367&itemid=87 (last visited mar. 1, 2013) (however there is a serious disparity between those fbs institutions at the top of the list in ticket revenue, producing over thirty-percent of their total revenue from ticket sale, and those at the bottom of the list, producing less than ten-percent of their total revenue from ticket sales. the lower revenue amounts generated from ticket sales force those institutions to rely more on allocated revenues, i.e., those revenues which come from student fees and institutional and governmental support.). 65 kristi dosh, big ten ticket revenue, the business of college sports (apr. 20, 2011), http://businessofcollegesports.com/2011/04/20/ big-ten-ticket-revenue. 66 id. the big ten institutions share 35% revenues generated from ticket sales for all conference home games in football, up to a season maximum of $4 million. for the 2009 football season, each big ten team received a $2.95 million distribution from shared football ticket sales revenues, which resulted in a net loss for six institutions while producing a net gain for five institutions. 67 in the big ten, three institutions have football stadiums with capacities greater than 100,000 (michigan 109,901, penn state 106,572, ohio state 102,329), while three institutions have football stadiums with about half those capacities (northwestern 47,130, minnesota 50,805, indiana 52,929). big ten conference, wikipedia, 2013 577 indiana health law review as the calls for greater athletic department services and student-athlete benefits intensify, it is likely that there will be the demand for greater intra-conference (and potentially inter-conference) revenue sharing as a means to finance the improved services and benefits. there are certainly lucrative revenue streams available that can be tapped to fund the improvements. c. member institutions as of 2011, there are 1073 active and twenty-seven provisional member institutions participating in ncaa sponsored athletics across three divisions. 68 by contrast, in 1950 there were 362 active member institutions. 69 the three divisions generally offer different levels of competition and student-athlete benefits. the divisions are subjected to different governance structures and must meet different standards and minimum requirements. division i, which contains 335 member institutions, generally provides greater student-athlete financial benefits than the other two divisions. 70 division i institutions may provide athletics-based grants-in-aid, which are provided in greater number and at greater values than by division ii or iii institutions, thanks in large part to greater financial resources. in 2010-11, 169,037 student-athletes participated in ncaa division i athletics,7 ' an average of 507.6 studentathletes per institution. 72 on average, division i member institutions sponsor 8.7 men's teams and 10.3 women's teams.73 http://en.wikipedia.org/wikilbigtenconference#football (last visited mar. 1, 2013). 68 membership report, supra note 13, at 5 6 9 id. 70 differences among the three divisions: division 1, ncaa (dec. 7, 2011), http://www.ncaa.org/wps/wcm/connect/public/ncaa/about+the +ncaa+old/who+we+are/differences+among+the+divisions/divisio n+i/about+division+i. 71 sports sponsorship and participation rates report, supra note 14, at 73. 72 id. at 188. 73 id. at 178. 578 vol. 10:2 ncaa student-athlete health care it is relevant to note that in the sport of football division i is further subdivided into three classifications: the football bowl subdivision (fbs), the football championship subdivision (fcs), and those institutions that do not sponsor football. these subdivisions significantly affect the financial returns realized by the member institutions, discussed infra in section iii. division ii, which contains 302 active member institutions and twenty-one provisional member institutions, also provides athletics-based grants-in-aid, but there are far fewer occurrences of those grants equaling a full grant-in-aid award. 74 generally, division ii student athletes receive partial athletics-based grants-in-aid and may also receive academic and/or need based financial aid. in 2010-11, 102,273 student-athletes participated in ncaa division ii athletics, 75 an average of 335.3 student-athletes per institution.76 on average, division ii member institutions sponsor 6.8 men's teams and 7.8 women's teams.77 division iii, which contains 436 active member institutions and six provisional member institutions, does not provide athletics-based grants-in-aid.78 furthermore, a greater portion of the total student body of division iii institutions participate in ncaa sponsored athletics (on average about 20% of the student body).79 in 2010-11, 172,767 student-athletes participated in ncaa division iii athletics,80 an average of 396 student-athletes per institution.81 on average, division iii member institutions sponsor 8.3 men's teams and nine women's teams. 82 74 differences among the three divisions:' division supra note 69. 75 sport sponsorship and participation rates report, supra note 15, at 74. 76 id. at 188. 77 id at 178. 78 differences among the three divisions: division i supra note 69. 79 id. 80 sports sponsorship and participation rates report, supra note 14, at 75. 81 id. at 188. 82 id. at 178. 2013 579 indiana health law review every member institution has its own independent goals based on its individual philosophy. the ncaa specifically encourages individualized philosophies among its member institutions. some institutions do in fact fashion the focus of their student-athletes on academics or some other aspect of their collegiate experience to a greater extent than athletics, or even in spite of athletics. an obvious example of member institutions trumping athletics with academics is the members of the ivy league, who compete at the fcs level of division i in football. since the league formed in 1954, the counsel of ivy group presidents has agreed to a rule that requires all members to decline participation in the fcs postseason championship tournament. 83 the stated reason for the rule is that the fcs tournament extends into the fall semester final exam period. 84 beyond this measure of athletics focus, the ivy league member institutions also decline to offer any athletics-based grants-in-aid to studentathletes.85 this policy also dates back to the leagues establishment, the point in history when the ncaa abandoned its own prohibition of athletics-based scholarships.86 it is argued this policy, like the policy foregoing postseason participation, is maintained so that the high academic standards of the member institutions will not be compromised.87 other institutions balance athletics and academics more evenly. duke university, an institution with a very wellrespected academic history, specifically expresses its belief 83 david burrick, ivy league not likely to see i-aa playoffs, the daily pennsylvanian (sept. 18, 2003, 5:00 am), http://thedp.com/ index.php/article/2003/09/ivyleague-notlikely_toseeiaa-playoffs. 8 4 id. 85 stated meeting of the trustees, ivy group agreement (jan. 18, 1954), http://www.archives.upenn.edu/histy/features/imagepenn/ivyl954.pdf (article iv(a)(f) states: "the members of the group reaffirm their prohibition of athletic scholarships. athletes shall be admitted as students and awarded financial aid only on the basis of the same academic standards and economic need as are applied to all other students."). 86 id. 87 michael shapiro, a call for ivy league athletic scholarships, columbia spectator (oct. 4, 2010), http://www.columbiaspectator.com/ 2010/10/04/sports-column. 580 vol. 10:2 ncaa student-athliete health care that there is educational value in championship level competition, yet explicitly states that graduation is the goal for all student-athletes.8 8 the individualized goals of each institution address the importance of athletics, academics, and various other values held to be instrumental to a complete college education. d. student-athletes during the 2010-11 academic year, 444,077 studentathletes participated in ncaa sponsored athletics.89 of those participants, 252,946 were men and 191,131 were women. overall participation has experienced a ninety-twopercent increase since the 1981-82 level of 231,445. participation by female student-athletes has nearly tripled during the same timeframe, up from 64,390. 88 mission statement for athletics at duke, duke university athletics, http://www.goduke.com/viewarticle.dbml?dboem id= 4200&atclid=152723 (last visited mar. 1, 2013) (stating: the guiding principle behind duke's participation in division i athletics is our belief in its educational value for our students. intercollegiate athletics promotes character traits of high value to personal development and success in later life. these include the drive to take one's talents to the highest level of performance; embracing the discipline needed to reach high standards; learning to work with others as a team in pursuit of a common goal; and adherence to codes of fairness and respect. duke aims for a level of athletic performance that will frequently produce winning seasons and the realistic opportunity to compete for team or individual championships. our mission also requires that duke athletes be students first, that they be admitted with careful attention to their academic record and motivation, that they benefit from duke's educational programs and make satisfactory progress toward a degree, and that their attrition and graduation rates be comparable to those of other students.). 89 sports sponsorship and participation rates report, supra note 14, at72. 5812013 indiana health law review during the 2010-11 academic year the highest participation men's sports were football (67,887), baseball (31,264), outdoor track (26,118), indoor track (22,750), and soccer (22,573).90 during the same period, the highest participation women's sports were women's outdoor track (25,295), women's soccer (24,671), women's indoor track (23,413), softball (18,188), and women's basketball (15,708).91 1. financial aid student-athletes are allowed to receive several different forms of permissible financial aid. certain forms of financial aid that student-athletes may receive are limited in aggregate to the amount of a full grant-in-aid. a full grantin-aid is defined as encompassing only "financial aid that consists of tuition and fees, room and board, and required course-related books."9 2 forms of financial aid limited to the amount of a full grant-in-aid include athletics grants-in-aid, other institutional financial aid, and non-institutional financial aid from sources other than state government. 93 other forms of financial aid are limited in aggregate to the amount of cost of attendance. "the 'cost of attendance' is an amount calculated by an institutional financial aid office, using federal regulations, that includes the total cost of tuition and fees, room and board, books and supplies, transportation, and other expenses related to attendance at the institution." 94 forms of financial aid limited to the cost of attendance include state government grants and summer school aid.95 student-athletes may also receive aid that is not subject to any amount limitations in the form of institutional honorary awards for outstanding academic achievement, federal government grants and loans, 90 id. at 197-198. 91 id. at 189-190. 92 division i manual, supra note 1, § 15.02.5, at 193. 93 membership report, supra note 13, at 90. 94 division i manual, supra note 1, § 15.02.2, at 192. 95 membership report, supra note 13, at 90. 582 vol. 10:2 ncaa student-athlete health care assistance from their parents or guardians, or income from employment.96 while student-athletes have several potential avenues to acquire financial assistance to cover the expense of their college educations, some of which is provided in exchange for athletic services, there has been an outcry by some that ncaa rules work to deny student-athletes fair compensation. furthermore, the number of athletics-based grants-in-aid that a member institution may award is limited by ncaa rules on a sport specific basis. member institutions are limited to a definite number of grants they may award per academic year. for example, while baseball accounts for the second highest participation total of all ncaa sponsored sports, with an average of 34.3 studentathletes participating on each division i team,97 division i bylaws limit the number of athletics-based grants-in-aid that the institution can award to 11.7 per academic year.98 student-athletes that participate in baseball will potentially be required to participate in fifty-six contests99 over the course of a 132-day season,100 while simultaneously being required to fulfill the requirements of a full-time academic schedule, yet will receive an athletics-based grant-in-aid which amounts on average to a waiver of one-third of that student's cost of attendance (as calculated by the institution). this situation has led groups such as the national collegiate players association (ncpa), a nonprofit advocacy group that seeks to improve the well-being of ncaa student-athletes, to demand greater benefits for student-athletes. 2. student-athlete groups there are two major student-athlete groups; the ncpa, a private group, unaffiliated with the ncaa, and the 96 id. 97 sports sponsorship and participation rates report, supra note 14, at 211. 98 division i manual, supra note 1, § 15.5.4, at 208. 99 id. § 17.2.5.1, at 245. 100 id. § 17.2.1, at 244. 5832013 indiana health law review student athlete advisory committee (saac), a nonvoting group associated with the ncaa. a. the national collegiate players association the ncpa (formerly known as the collegiate athletes coalition) was formed in january of 2001 by a group of ucla football players, led by linebacker ramogi huma.101 huma found himself compelled " to form a student group that would allow college athletes to voice their concerns and change ncaa rules" after witnessing his all-american teammate donnie edwards receive a suspension for accepting groceries when his financial aid funds were exhausted and he could not personally make the purchase.102 the group was initially organized as a national group of college football players, but its membership has expanded to include over 17,000 current and former division i athletes from various sports (although membership predominately represents men's basketball and football, the revenue generating sports).103 "the group [seeks to] bring about reforms by providing a strong voice for student-athlete concerns both publicly and in direct dealings with individual colleges and the ncaa."104 in addition to a large membership base, the ncpa has the support of a major labor union: the united steelworkers of america. 05 the steelworkers provide the ncpa with legal and technical counsel and have helped the ncpa remain organized and focused on its goals. 06 101 jonathan l. h. nygren, forcing the ncaa to listen: using labor law to force the ncaa to bargain collectively with studentathletes, 2 va. sports & ent. l.j. 359, 366 (2003). 102 about the ncpa president, nat'l college players ass'n, http://www.ncpanow.org/more?id=0005 (last visited mar. 1, 2013). 103 about ncpa, nat'l college players ass'n, http://www. ncpanow.org/about/ (last visited mar. 1, 2013). 104 paul c. weiler et al., sports and the law: texts, cases, and problems 921 (4th ed. 2011). 105 ncpa & usw a winning team, nat'l college players ass'n, http://www.ncpanow.org/ncpausw?id=0003 (last visited mar. 1, 2013). 106 id. 584 vol. 10:2 ncaa student-athlete health care the ncpa website currently lists eleven goals for the group. the goals are to (1) minimize college athletes' brain trauma risks; (2) raise the scholarship amount; (3) prevent players from being stuck paying sports-related medical expenses; (4) increase graduation rates; (5) protect educational opportunities for student-athletes in good standing; (6) to prohibit universities from using a permanent injury suffered during athletics as a reason to reduce or eliminate a scholarship; (7) establish and enforce uniform safety guidelines in all sports to help prevent serious injuries and avoidable deaths; (8) eliminate restrictions on legitimate employment and players ability to directly benefit from commercial opportunities; (9) prohibit the punishment of college athletes that have not committed a violation (i.e., declaring an institution ineligible for postseason play as a result of transgressions committed by former student-athletes or coaches); (10) guarantee that student-athletes are granted an athletic release from their institution if they wish to transfer; and (11) allow all college athletes of all sports the ability to transfer schools one time without punishment (currently, the "transfer rule" requires student-athletes that participate in football, basketball, baseball, or ice hockey to sit out a full season at the new institution prior to being eligible for athletic participation). 107 many of the stated goals of the ncpa have received attention recently from the media and the ncaa. in fact, one goal formerly listed on the ncpa website, to allow universities to provide multiple year grant-in-aid offers, was recently approved by the ncaa and survived a membership override vote in february 2012.108 while the ncpa does not enjoy collective bargaining rights with the ncaa on behalf of student-athletes, it does appear that when the group takes issue with some facet of ncaa regulations, that facet 107 mission & goals, nat'l college players ass'n, http://www.ncpanow.org/more?id=0004 (last visited mar. 1, 2013). 108 michelle brutlag hosick, multiyear scholarship rule narrowly upheld, nat'l college players ass'n, (feb. 17, 2012), http://www.ncaa. org/wps/wcm/connect/public/ncaa/resources/atest+news/2012/february multiyear+scholarship+rule+narrowly+upheld (last visited mar. 1, 2013). 2013 585 indiana health law review at least becomes a talking point among the membership of the association. b. the student-athlete advisory committee "a student-athlete advisory committee (saac) is a committee made up of student-athletes assembled to provide insight on their experience. the saac also offers input on the rules, regulations and policies that affect student-athletes' lives on ncaa member institution campuses." 109 each division has its own separate saac structure. 110 in each division, each conference elects one saac representative who in turn provides input to the regulatory bodies within the ncaa. "the mission of the national collegiate athletic association student-athlete advisory committee is to enhance the total student-athlete experience by promoting opportunity, protecting studentathlete welfare and fostering a positive student-athlete image."111 saac representatives act in a purely advisory capacity, offering opinions on ncaa rules, regulations, and policies that affect the well-being of student-athletes as they attempt to acquire their education and participate in ncaa sponsored athletics. unfortunately, saac representatives have no voting power, and while the representatives can offer opinions to ncaa regulatory bodies, those opinions can easily be discounted or disregarded without any redress for student-athletes. 109 nat'l collegiate athletic ass'n, student athlete advisory committee 2 (2011), available at http://www.ncaapublications.com/p4147-student-athleteadvisory-committee. aspx (last visited mar. 1, 2013). 110 id. 111 id. at 4. 586 vol. 10:2 ncaa student-athlete health care iii. ncaa finances a. ncaa revenues and expenses of division i intercollegiate athletics programs report 2004-2010 and discussion of the bowl championslup series revenues in august 2011, the ncaa released the ncaa revenues and expenses of division i intercollegiate athletics programs report, a study examining the generated revenues and operating expenses of member institutions over a seven-year period from 2004 through 2010.112 the report subdivides the presentation of data by the division i football subdivisions. to collect the data, the ncaa distributed surveys to every member institution at the conclusion of each fiscal year. the data presents the median amounts for each category based on the institutions responses, as well as the largest amount of institutional revenue and expense reported. the data is broken down into different degrees of specificity, including amounts categorized by individual sport, the revenue generating sports, source of expenses, and discloses the number of institutions with net surpluses and the number with net losses. some key findings of the study for the fiscal year 2010 are as follows: generated revenues increased for median fbs institutions (9.5 percent increase) and fcs institutions (14 percent increase) from 2009 to 2010, while generated revenues decreased over the same period for member institutions without football (5.1 percent decrease).113 median expenses increased at a slower rate for both fbs and fcs institutions during the same period. 114 fbs institutions reported median net revenues of $1.61 million. 115 fcs institutions reported median net revenues of 112 nat'l collegiate athletic ass'n, revenues and expenses 2004 2010: ncaa division i intercollegiate athletics programs report (2011), available at http://ncaapublications.com/p-4237-20042010-revenues-and-expenses.aspx (last visited mar. 1, 2013) [hereinafter revenue report]. 113 id. at 8. 114 id. 115 id. at 17. 2013 587 indiana health law review $98,000 for 2010.116 division i institutions without football reported median deficits of $485,000 for 2010.117 the greatest contribution to athletics expenses are salaries and benefits for coaching staffs and athletics personnel. looking at 2010 as a representative year, fbs institutions reported median salaries and benefits amounted to $15.88 million in athletics expenses.118 fcs institutions reported median salaries and benefits amounted to $4.16 million in athletics expenses. 119 division i institutions without football reported median salaries and benefits amounted to $3.65 million in athletics expenses.120 in contrast, fbs institutions reported median grants-in-aid account for $7.24 million and median medical costs account for $545,000 in athletics expenses.121 fcs institutions reported median grants-in-aid account for $3.51 million and median medical costs account for $177,000 in athletics expenses.122 division i institutions without football reported median grants-in-aid account for $3.31 million and median medical costs account for $118,000 in athletics expenses.123 at every level of ncaa division i athletics, the median institution spends more on coaching and athletics personnel salaries than on financial aid and medical benefits for student-athletes. 12 4 one additional troubling finding is that only twenty-two of the 335 division i institutions reported positive net revenues for 2010, which was an increase of eight institutions from 2009.125, 126 relaxed accounting principles 116 id. 117 id. 118 id. at 31. 119 id. at 57. 120 id. at 83. 121 id. at 31. 122 id. at 57. 123 id. at 83. 124 fbs: $15.88 million for coaches and administration compared to $7.79 million for student-athletes; fcs: $4.16 million for coaches and administration compared to $3.69 million for student-athletes; di without football: $3.65 million for coaches and administration compared $3.43 million for student-athletes. 125 id. 588 vol. 10:2 ncaa student-athlie if hi alth care may explain the low number of institutions reporting positive net revenues. athletic departments often give portions of their revenues back to the institutions for other endeavors, such as construction or academic projects, and those revenues are treated as athletic expenses.127 nevertheless, true athletic expenses exceed generated and allocated revenues at many institutions, especially those institutions that do not experience high levels of athletics success in the revenue generating sports of football and men's and women's basketball. although not ncaa revenues (and therefore not discussed in the ncaa revenue report), fbs revenues are further affected by the bowl championship series (bcs), a five-game postseason exhibition that is supposed to showcase matchups of the top college football teams, including a matchup of the top-two teams in the bcs championship game, which serves as the fbs national championship. 1 2 8 the bcs is not affiliated with the ncaa, but rather it is an operation between the fbs member conferences.129 the bcs was formed by the six "major conferences" and notre dame in 1998, intended to ensure that the top two football teams in the nation would meet for a national championship game at the season's end. 130 today, the bcs is managed by the commissioners of the 126 kristi dosh, self-sustaining athletic departments: more than what meets the eye, the business of college sports (june 16, 2011), http://businessofcollegesports.com/2011/06/16/self-sustaining-athleticdepartments-more-than-what-meets-the-eye/ (last visited mar. 1, 2013) (all twenty-two institutions that reported net revenues are members of "major conferences": atlantic coast virginia tech; big east west virginia, big ten indiana, iowa, michigan, michigan state, ohio state, penn state, purdue; big xii kansas state, nebraska, oklahoma, oklahoma state, texas, texas a&m; pacific 12 oregon, washington; southeastern alabama, arkansas, florida, georgia, louisiana state). 127 id. 128 bcs background, bcsfootball.org, http://www.bcsfootball. org/news/story?id=4809699 (last updated jan. 16, 2012, 5:06 pm) (last visited mar. 1, 2013). 129 id. 130 the bowl championship series overview, national football foundation, http://www.footballfoundation.org/programs/bcs.aspx (last visited mar. 1, 2013). 5892013 indiana health law review eleven fbs conferences and the athletic director of notre dame. 131 currently, the bcs offers automatic qualification to the champions of the six "major conferences." 13 2 the champions of the remaining five fbs conferences and notre dame may earn an automatic berth if their season-ending bcs ranking meets certain thresholds. 133 if any of the ten available bcs slots remain unfilled after all the automatic qualifiers receive invitations to bcs bowl games, and if a team from one of the "major conferences" is ranked third in the seasonending bcs rankings and that team did not receive the conference's automatic bid (i.e., did not win the conference championship), then that team becomes an automatic qualifier. if the third place team did receive an automatic bid, then the invitation goes to the team ranked fourth if that team did not receive the conference's automatic bid. if any slots remain after all automatic qualifiers are placed in bcs bowl games, then the bcs bowls may select any bcs eligible team as an "at large" selection. 134 a bcs eligible team is defined as a team that finishes the season with nine or more victories and is in the top fourteen of the seasonending bcs rankings, subject to a limit that no more than two teams from the same conference may participate in bcs bowl games. 135 if after selecting from the bcs eligible field slots still remain, then the bcs eligibility definition is expanded by four season-ending bcs rankings until all slot are filled, still subject to the limitation that no more than two teams from the same conference participate in bcs bowl games. 131 bcs governance, bcsfootball.org, http://www.besfootball. org/news/story?id=4809846 (last updated feb. 8, 2013, 11:48 am et) (last visited mar. 1, 2013). 132 bcs selection procedures, bcsfootball.org, http:/www. bcsfootball.org/news/story?id=4819597 (last updated july 21, 2011, 1:30 pm et) (last visited mar. 1, 2013). 133 id. 134 id. 135 id. there is one exception to the two team limitation. if two teams from the same conference finish the season ranked number one and number two in the season-ending bcs rankings, but neither team receives the conference's automatic bid, that conference may send three teams to bcs bowl games. 590 vol. 10:2 ncaa student-ati i ii i i:altih care the bcs annually distributes revenue to the conferences and independent member institutions. for the 2010-2011 season, if a conference had a team that automatically qualified for a bcs bowl game, then that conference received a $22 million distribution. 136 if an additional team participated in a bcs bowl game, that conference received an additional $6 million distribution. 137 notre dame received a $1.6 million distribution. 138 army and navy received $100,000 distributions, respectively. 139 each fcs conference received a $250,000 distribution. 14 0 however, on june 26, 2012, the fbs conference commissioners formally approved a four-team playoff to replace the current bcs structure beginning in 2014, which will run through at least 2025.141 the new playoff format has already been informally dubbed the "national championship series" by new big 12 commissioner bob bowlsby. 142 this imminent name change is likely an attempt to reduce the negative stigma that the bcs has garnered in past years for the several so-called snubs of potential national championship quality teams. more notable than the change in the name and format of the series is the increase in television revenues that the recently agreed upon contract between the former bowl championship series and espn will produce. the twelveyear contract is reportedly worth $5.64 billion total, or 136 the bcs is..., bcsfootball.org, http://www.besfootball.org/ news/story?id=4809716 (last updated july 22, 2011, 1:09 pm et) (last visited mar. 1, 2013). 137 id. 138 id. 139 id 140 id. 141 heather dinich, playoff plan to run through 2025, espn.com, http://espn.go.com/college-football/story/_/id/8099187/ncaa-presidentsapprove-four-team-college-playoff-beginning-2014 (last updated june 27, 2012, 1:12 pm et) (last visited. mar. 1, 2013). 142 tim griffin, new leader sees big 12 in power formation, mysanantonio.com, http://www.mysanantonio.com/sports/college sports/big_12/article/new-leader-sees-league-in-power-formation3684738.php (last updated july 5, 2012, 12:03 am) (last visited mar. 1, 2013). 5912013 indiana health law review roughly $470 million annually, 143 an amount that is just over three times more than the current $155 million paid per year for the broadcast rights to the five bcs bowl games.144 another key feature of the new national championship series will be the abandonment of the automatic qualification for conference champions. 145 the new format will include six bowl games that will alternate as locations for the national semi-final games from year-to-year. 14 6 in the years those bowls are not semi-finals games, they will function much like the former bcs bowl games, inviting the top teams in the nation to participate. 147 five of the traditional "major conferences" and notre dame have entered into contracts with three bowl games expected to be a part of the six top-tier bowl games that will alternately serve as the semi-final games, likely creating a de facto automatic qualification for those conference champions. 148 the move from five top-tier bowl games to six will increase access for the top teams to compete in more lucrative bowl games. this could potentially increase access and revenues for the non-major conferences, however there is speculation that the distribution percentages will more than likely remain much the same as they have been under the bcs system. 149 a playoff revenue-split subcommittee 143 rachel bachman, espn strikes deal for college football playoff wall st. j. (nov. 21, 2012, 1:46 pm), http://online.wsj. com/article/sb10001424127887324851704578133223970790516.html (last visited mar. 1, 2013). 144 kristi dosh, ncaa football payouts may stay the same, espn.com (june 25, 2012, 3:56 pm et), http://espn.go.com/ blog/playbook/dollars/post/_/id/767/ncaa-football-payouts-may-notchange-much (last visited mar. 1, 2013). 145 dinich, supra note 140. 146 id. 147 id. 148 brian murphy, college football playoffs starting to look like bcs 2.0, idaho statesman, http://voices.idahostatesman.com/ 2012/07/03/bmurphy/collegefootball_playoffs-starting_1ook_bcs_20 (last updated july 3, 2012, 2:25 pm) (last visited mar. 1, 2013) (stating that only the big east has not entered into a contract with one of the expected top-tier bowl games). 149 dosh, supra note 143. 592 vol. 10:2 ncaa student-athlete h[alth care has been formed by the fbs conference commissioners to determine the appropriate distribution model. 151) the subcommittee is made up of a majority of commissioners from the former automatic qualification conferences and it seems hard to imagine that those commissioners will act contrary to their own conferences' financial interests. yet, with an estimated additional $350 million per year to divide between fbs conferences, even under the current distribution model all fbs institutions will see a large increase in athletic department revenues that may help to reduce athletic department deficits. b. ncaa membership report 2009-2010 the ncaa is a 501(c)(3) not-for-profit charitable organization so much of the association's financial information is public record. the ncaa membership report is an annual report detailing the financial data of the association and its membership. during the 2009-2010 year, the ncaa generated $749,822,258 in revenue, 85.7 percent of which was generated from television and marketing rights.151 152 the majority of the revenue generated from television and marketing rights comes from the ncaa contract with cbs and turner broadcasting for the broadcast rights to the ncaa division i men's basketball championship.153 the current fourteen-year agreement, which runs from 2011 through 2024, will earn the ncaa $10.8 billion. 154 150 ben kercheval, playoff revenue-split subcommittee features four "big five" commissioners, nbcsports.com (june 28, 2012, 7:53 pm est), http://collegefootballtalk.nbcsports.com/2012/06/28/playoffrevenue-split-subcommittee-features-four-big-five-commissioners (last visited mar. 1, 2013). 151 membership report, supra note 13, at 26. 152 the total is estimated to be about $871.6 million for 2011-12. revenue, ncaa.org, http://www.ncaa.org/wps/wcm/connect/public/ ncaa/finances/revenue (last updated feb. 13, 2013) (last visited mar. 1, 2013). 153 id. 154 id. 5932013 indiana health law review during the 2009-2010 year, the ncaa sustained $707,224,333 in expenses, sixty-one percent of which was distributions to the division i member institutions and nine percent which was spent on division i championships and programs, four percent of which was distributed to division ii member institutions and spent on division ii championships and programs, and three percent of which was spent on division iii championships and programs.155 the division i distributions are made directly to conferences from seven funds that base their distribution on the combined performance and student-athlete assistance statistics of conference member institutions. 15 6 these funds include the basketball fund (distributed based on the performance of member institutions in the ncaa men's basketball championship tournament), the academic enhancement fund (distributed "in response to proposals of innovative solutions and efforts to increase student athlete retention and progress -towards -degree success"), the conference grant fund (distributed to conferences that employ a full-time administrator and are eligible for an automatic qualification to the ncaa men's basketball championship tournament), the special assistance fund (distributed based on the number of grants-in-aid awarded and the number of sports sponsored by a conference) the sports-sponsorship fund (distributed based on the number of athletics grants-in-aid awarded and the number of sports sponsored by the member institutions individually), the grant-in-aid fund (distributed on the same basis), and the student-athlete opportunity fund (distributed on the same basis).157 this distribution model may perpetuate the problem of athletics revenue disparity between member institutions. while it is seemingly reasonable that institutions that invest more money in their athletics programs should receive more returns, it is highly likely that the institutions receiving lower distributions from the ncaa are unable to compete on the same level with institutions that historically 155 membership report, supra note 13, at 27. 156 id. at 29-33. 157 id. 594 vol. 10:2 ncaa student-atilete h1 ealtii cari receive more financial distributions, and therefore are unable to increase grant-in-aid totals or improve the performance of the basketball program. the disparity also leads to inequalities between student-athletes at different institutions, which seemingly clashes with one of the stated core values of the association, the goal of creating "[a]n inclusive culture that fosters equitable participation for student-athletes . . . from diverse backgrounds." 15 8 the disparity is obvious when one reviews the conference distribution totals for 2009-2010. the six "major conferences" received $206,670,709 of the $434,648,083 division i ncaa revenue distribution.159 that means seventy-three of the 335 total division i institutions received 47.5% of the division i revenue distributed. that is an average of $2.83 million for each of the seventy-three schools. 160 by contrast, the atlantic sun conference, with a membership of ten institutions, received a total distribution of $3,774,448.161 when compared to the total $544,010,933 revenue distributed to all 1073 active ncaa member institutions, the seventy-three "major conference" members received 38.0% of the total revenue distributed.162 the "major conference" member institutions make up less than seven percent of the ncaa's membership. 163 these percentages illustrate the economic incentives that are influencing the current conference realignment movement in college sports. yet, his distribution model is more than likely fair when viewed from a pure laissez-faire perspective, considering the value added to the ncaa product by each individual 158 core values, supra note 45. 159 membership report, supra note 13, at 35. 160 this average is not a clear reflection of the actual amount received by all institutions in the "major conferences." each conference received a different distribution amount and those conferences contain different numbers of member institutions; therefore, some "major conference" institutions averaged lower than this figure while others average above. however, all six "major conferences" received distributions in excess of $30 million. 161 membership report, supra note 13, at 35. 162 $206,670,709 divided by $544,010,933 equals 37.99569%. 163 73 divided by 1073 equals 6.8%. 2013 595 indiana health law review conference and its respective member institutions. the "major conferences" draw far greater fan support and therefore generate greater revenues. yet, when the overarching goal is education, and not merely athletic success, it may be necessary to question whether perpetuating this disparity in revenues between educational institutions is appropriate. also, ncaa revenues (revenues which the association itself generates) do not demonstrate the complete picture. ncaa research staff estimate that the institution athletic programs generate approximately $6.1 billion annually from ticket sales, radio and television receipts, alumni contributions, guarantees, royalties and ncaa distributions. 164 the institutions receive an additional $5.3 billion in allocated revenues, from sources such as student fees, institutional support, and governmental support. 165 in total, ncaa athletics was an $11.4 billion industry in 2011. c. the 'scholarship shortfall" problem a "scholarship shortfall" refers to the difference between a full athletics-based grant-in-aid and the cost of attendance for the student-athlete at the institution. 166 a full athleticsbased grant-in-aid is limited to "financial aid that consists of tuition and fees, room and board, and required courserelated books." 167 this limitation leaves a gap between the financial aid that student-athletes receive and the costs required to attend the institution. the student-athletes are left responsible to account for the gap. because the costs associated with attendance vary between institutions, this gap is a greater burden on some student-athletes than 164 revenue: frequently asked questions, nat'l collegiate athletic ass'n, http://www.ncaa.org/wps/wcm/connect/public/ncaa/ finances/revenue (last updated feb. 13, 2013) (last visited mar. 1, 2013). 165 id. 166 press release, nat'l collegiate players ass'n, scholarship shortfall study reveals college athletes pay to play, ncpanow.org, http://www.ncpanow.org/releasesadvisories?id=0009 (last visited march 1, 2013). 167 division i manual, supra note 1, § 15.02.5, at 193. 596 vol. 10:2 ncaa student-athlete health care others. a joint study by the ncpa and the ithaca college graduate program in sports management found that on average, the shortfall at division i institutions is $2,951 per year, or $14,755 over five years (the maximum duration of an athletics-based grant-in-aid).168 however, the shortfalls ranged from about $200 up to $10,962 per year. 169 at the upper end of the spectrum, student-athletes receiving full athletics scholarships are responsible for approximately $55,000 over the course of their college education. that is inconsistent with the idea of a "free ride" that most people believe student-athletes enjoy. contributing further to this burden, due to the academic and athletic commitments embraced by student-athletes, there is often little or no time for student-athletes to earn any income through the channels allowed by ncaa regulations to cover extra expenses. in season, studentathletes put in near full-time hours in practice and competition participation. teams are limited to twenty hours of athletics participation per week during the season, 170 however common sense suggests that this limit operates as a minimum number of practice hours per week.171 further, the ncaa interprets each competition to equal no more than three hours, irrespective of travel and preand post-game time requirements. institutions are required to give student-athletes one day off per week during the season,172 however travel days may be counted as off-days. 173 given these realities, it is easy to see how student-athletes may dedicate in excess of forty hours per week to athletics participation during the season. student-athletes are also required "to be enrolled in at least a minimum full-time program of studies, be in good 168 scholarship shortfall study reveals college athletes pay to play, supra note 165. 169 id. 170 division i manual, supra note 1, § 17.1.6.1, at 238. 171 it is reasonable to assume that teams will use the full amount of practice time allowed. to use less would offer the team's opponent an opportunity to gain an advantage in being more prepared for the contest. 172 divsion i vianual, supra note 1, § 17.1.6.4, at 240. 173 id. § 17.1.6.4.1, at 240. 5972013 indiana health law review academic standing and maintain progress toward a baccalaureate or equivalent degree." 174 generally, this requires a student-athlete to enroll in a minimum of twelve credit hours per semester and maintain a 2.0 gpa.175 such a study regiment requires a significant time commitment from the student-athlete in addition to their athletic participation. at best, it would be an undue burden for student-athletes to handle the added time commitment of part-time employment necessary to earn the income required to compensate for any shortfall left by their full athletics-based grant-in-aid. iv. the current state of ncaa legal affairs a. recent ncaa regulatory action on october 27, 2011, the division i board of directors (the "board") of the ncaa adopted legislation that allows member institutions to provide student-athletes that "receive full athletic scholarships or get other school financial aid combined with athletic aid to equal a full scholarship" with either the difference between the amount of aid received and the institution's calculation of full cost of attendance or with $2,000, whichever is less (the "miscellaneous expense allowance").176 on january 14, 2012, following the objection of at least 160 of the 335 division i institutions to the adoption of the miscellaneous 174 id. § 14.01.2, at 143. 175 it should be noted that these requirements are only the minimum necessary to continue athletics participation. they do not ensure that the student-athletes will be well-positioned following the exhaustion of their ncaa eligibility to succeed in the job market or continue their education. in fact, taking the minimum number of credit hours every semester may not even meet the required number of credit hours for graduation for some student-athletes, depending on their degree choice. 176 michelle brutlag hosick, latest news, nat'1 collegiate athletic ass'n, di board adopts improvements in academic standards and student-athlete support, nat'l collegiate athletic ass'n (oct. 27, 2011), http://www.ncaa.org/wps/wcm/connect/public/ncaa/resources/ latest+news/201 1/october/di+board+of+directors+adopt+changes+to+ academic+and+student-athlete+welfare (last visited mar. 1, 2013). 598 vol. 10:2 ncaa student-athlete health care expense allowance, the board voted to delay implementation of the legislation and requested a modified proposal from the student-athlete well-being working group in april 2012.177 following the 2013 ncaa convention, which took place in january 16-19, now more than " [a] year after the board delayed implementation of a $2,000 miscellaneous expense allowance for student-athletes to help cover the full cost of attendance, there [has been] no new proposal for consideration on the issue."178 the initial decision to delay implementation by the board was influenced by numerous concerns expressed by the member institutions; however the association appears to remain determined to implement some form of the reform measure. following the board's january 2012 delay and request for a modified proposal, ncaa president mark emmert told reporters that "[ilt would be very inaccurate to describe this as a setback for the $2,000, but rather [it is] a clear attempt to get it right," classifying the stipend as "obviously an important element of student well-being."179 even so, it remains a possibility that the miscellaneous expense allowance will never realize enactment.180 177 michael marot, ncaa asks for new proposal on $2,000 stipend, associated press, jan. 14, 2012, available at http://abcnews.go.com/ sports/wirestory/ncaa-asks-proposal-2000-stipend-15362463#.txrvpygwvlc. 178 associated press, nc.a.a. changes rules at convention, n.y. times, (jan. 19, 2013), http://www.nytimes.com/2013/01/20/sports/ncaachanges-rules-at-convention.html?_r=0. 179 steve wieberg, ncaa to modify $2,000 stipend proposal, usa today, (jan. 14, 2012), http://www.usatoday.com/sports/college/ story/2012-0114/ncaa-stipend-money/52559576/1?csp=34sports. 180 id. (following adoption of legislation by the ncaa division i board of directors, the member institutions can suspend implementation of the rule by forcing an override vote. this requires objections in writing from 125 of the 335 member institutions. this has occurred regarding the $2,000 stipend. as it currently stands, after reevaluation of the legislation in april, the board will again be charged with adopting or rejecting the legislation. should the board adopt the legislation, the member institutions will be granted another 60-day comment period and, once again, an opportunity to force an override vote, starting this stage of the process all over again. if the board does not concede to the override vote, the legislation would then be put to issue by a vote of the 335 member institutions. at that point, in order to 2013 599 indiana health law review the student-athlete well-being working group has considered and sought feedback on three options for implementing the miscellaneous expense allowance.181 the first option would allow each institution to award up to the additional $2,000 to any student-athlete, regardless of need or whether they receive a full grant-in-aid. 182 as part of this option, an institution can prorate the additional award for student-athletes receiving partial grants-in-aid to the percentage of their grant (i.e., a student-athlete receiving a 25% scholarship could receive $500 of additional aid).183 the second option would "[blase eligibility for the miscellaneous expense allowance on a student-athlete's demonstrated 'need' as detailed through the free application for student financial assistance (fafsa)."184 the third option would allow institutions to use the student-athlete opportunity funds to provide the miscellaneous expense allowance.185 no further debate by the division i membership is expected to take place prior to april 2013.186 ramogi huma, president of the national college players association, questions the effectiveness of the additional aid if a need-based model is accepted by the division i board. 87 huma stated that he believes that "basing the stipend on financial need would be ineffective because most athletes have too much money to qualify for need-based aid through the ncaa."188 huma supports one of the other two options override approval of the legislation, a five-eighths majority (209 of 335) would be required to vote against approval. if less than a five-eighths majority objects the legislation would then be approved and enacted.) 181 michelle hosick, di board pledges to move forward with feedback from the membership, ncaa.org (ap. 26, 2012), http://www.ncaa.org/wps/wcm/connect/public/ncaa/resources/latest+n ews/2012/april/di+board+pledges+to+move+forward+with+feedback+fr om+the+membership. 182 id 183 [d. 184 id 185 id 186 associated press, supra note 177. 187 jon soloman, ncaa considers scholarship stipend for athletes based on financial need, al.com (may 14, 2012, 9:00 am), www.al.com/sports/index.ssfl2012/05/ncaaconsidersmorescholarshi.html. 188 id. 600 vol. 10:2 ncaa student-athlete healtih care more than a need-based model because it will make recruits aware in advance of signing a national letter of intent whether or not they will receive the additional aid. if it's need based, no school can guarantee any recruit whether they can get anything because they wouldn't know if they qualify or not .... two of the three proposals would be a small step in the right direction. it's not a solution. it's a band-aid, but there would still be bleeding.189 despite these concerns, it appears that the need-based model appears to have more support from division i membership. according to ncaa division i vice president david berst, "[tihere's probably more interest (by the membership) on some type of need-based option, if there's a shortcut to determine what need is."190 the process must play out and to determine whether any of the options is adopted by the division i board in august and whether the option will be approved and enacted by the membership. at the earliest, a regulation could be enacted by the end of 2013. b. antitrust law antitrust law is the strongest weapon in studentathletes arsenal to challenge the impact of ncaa regulations. student-athletes perform a service in exchange for benefits; the situation demands that student-athletes have a form of recourse should the actions of ncaa membership disrupt the reasonable and efficient exchange of services and benefits. antitrust courts must inquire whether ncaa regulations work individually or in combination to restrict competition between the member institutions for student-athlete services. this inquiry assumes a student-athlete labor market, a market which has recently received explicit recognition from federal courts 189 id. 190 id 6012013 indiana health law review presented with antitrust challenges to ncaa commercial regulations. by judging the reasonableness of ncaa restrictions on the student-athlete labor market, antitrust courts may ensure student-athletes are adequately protected from potential exploitation by institutions engaged in a multibillion-dollar industry. 1. ncaa. v. board of regents of the university of oklahoma and university of georgia athletic association since the supreme court's decision in ncaa v. board of regents of the university of oklahoma, the ncaa has been recognized as an association of competitors in "an industry in which horizontal restraints on competition are essential if the product is to be available at all."191 in board of regents, justice stevens gave examples of the sort of restrictions that may justifiably be placed on ncaa member institutions without eliciting antitrust liability, such as "rules defining the conditions of the contest, the eligibility of participants, or the manner in which members of a joint enterprise shall share the responsibilities and the benefits of the total venture."192 regardless of these allowances, justice stevens made it clear that ncaa regulations may not reduce "the importance of consumer preference in setting price and output."193 nor may the ncaa "blunt[ i the ability of member institutions to respond to consumer preference."19 4 for the purposes of antitrust review, the court announced two potential procompetitive justifications for ncaa restrictive regulations: amateurism and competitive equity. the court reasoned that amateurism was the key feature that separated ncaa sponsored athletics from athletic competitions sponsored by professionalized leagues, 191 nat'l collegiate athletic ass'n v. bd. of regents of the univ. of oklahoma, 468 u.s. 85, 101 (1984). 192 id. at 117. 193 id. at 107 (noting that "congress designed the sherman act as a 'consumer welfare prescription.' ") (quoting reiter v. sonotone corp., 442 u.s. 330, 343 (1979)). 194 id. at 120. 602 vol. 10:2 ncaa student-athlete health care and therefore ncaa athletics were indeed a separate product. the court concluded that: in order to preserve the character and quality of the "product," athletes must not be paid, must be required to attend class, and the like. and the integrity of the "product" cannot be preserved except by mutual agreement. . . . thus, the ncaa plays a vital role in enabling college [athletics] to preserve its character, and as a result enables a product to be marketed which might otherwise be unavailable. in performing this role, its actions widen consumer choice not only the choices available to sports fans but also those available to athletes and hence can be viewed as procompetitive.195 therefore, ncaa regulations tailored to preserve the "amateur" nature of the competition, such as prohibiting benefits in excess of the cost of attendance, do not upset the antitrust laws. the court further found that if the product was to succeed in the marketplace, competitive equity was reasonably necessary, because otherwise fans would not have interest in the product and ncaa athletics would fail.196 however, regulations intended to maintain competitive equity must be narrowly tailored to achieve that purpose.197 while the court theorized that it might be reasonable to "regulate the amount of money that any college may spend on its football program, [ ]or the way in which the colleges may use the revenues that are generated 195 id. at 102. 196 id. at 117 (accepting the ncaa's argument "that the interest in maintaining a competitive balance among amateur athletic teams is legitimate and important."). 197 id. (rejecting the ncaa's argument that the regulation of all television broadcasts of intercollegiate football was necessary to maintain competitive equity because the plan was "not related to any neutral standard or to any readily identifiable group of competitors.") 6032013 indiana health law review by their football programs," 198 its ultimate finding that "consumption will materially increase if the controls are removed" dictated its holding that the ncaa's regulation of all televised intercollegiate football games violated section 1 of the sherman act. 199 2. the ncaa as a monopsony the competitive equity justification was further shaped by the court of appeals for the tenth circuit in law v. ncaa.200 the case dealt with the "restricted earnings coach" rule (rec rule) that required one coach per coaching staff in a given sport to be classified as a "restricted earnings coach" with a salary limit set at $12,000 during the academic year and $4,000 during the summer. the ncaa argued that because athletics personnel salaries present the highest athletics expenses for member institutions, the rec rule was tailored to reduce institution athletics expenses and therefore promote competitive equity between the member institutions. 201 the court rejected the ncaa's argument, finding the rec rule operated as a price fix. the court approved the "quick-look" rule of reason approach, relieving the plaintiffs of their burden to specifically define the relevant market, and proceeded to find the ncaa could not demonstrate procompetitive justifications for the rule. 2 0 2 finding the rec rule was nothing more than a cost-cutting measure, the court declared "cost-cutting by itself is not a valid procompetitive justification."203 the court concluded "[tihe ncaa's cost containment justification [was] illegitimate because . . . '[i]f holding down costs by the exercise of 198 id. at 119. 199 id. at 120. 200 law v. nat'l collegiate athletic ass'n, 134 f.3d 1010 (10th cir. 1998). 201 id. at 1014. 202 id. at 1023 ("[tlhe ncaa presents no evidence that limits on restricted-earnings coaches' salaries would be successful in reducing deficits, let alone that such reductions were necessary to save college basketball."). 203 id. at 1022. 604 vol. 10:2 ncaa student-athlete health care market power over suppliers, rather than just by increased efficiency, is a procompetitive effect justifying joint conduct, then section 1 can never apply to input markets or buyer cartels.' "211-1 the court implicitly suggested that the rec rule worked as an exercise of monopsony market power by ncaa member institutions to restrict competition in the coaching input market, thereby harming competition, not improving competitive equity.2 0 5 the relevant market being ncaa coaching positions, the imposition of restrictions by the ncaa on the maximum salary for those positions, unifying the buying practice of all member institutions, created a "buyer's monopoly" for the institutions to the detriment of competition in that market. the principles expressed by in law were later applied in the context of an antitrust challenge brought by players. in in re ncaa ia walk-on football players litigation, a plaintiff class of walk-on football players at division i institutions alleged ncaa regulations restricting the number of grants-in-aid for football at each school were an anticompetitive agreement in violation of the sections 1 and 2 of the sherman act.2 0 6 the district court denied the ncaa's motion to for judgment on the pleadings, finding that the plaintiffs had "alleged a sufficient 'input' market in which ncaa member schools compete for skilled amateur football players."207 the court noted that other "courts have also found the award of financial aid to college students to be 'trade or commerce' and therefore subject to the sherman act."2 0 8 the court found the plaintiffs' claim that ncaa football was the relevant market sufficient to survive the ncaa's motion, accepting the plaintiffs allegation that 204 id. at 1023 (quoting gary roberts, the ncaa, antitrust, and consumer welfare, 70 tul l. rev. 2631, 2643 (1996)). 205 see id. at 1022-1024. see generally weyerhaeuser co. v. rosssimmons hardwood lumber co., inc., 549 u.s. 312, 320 (2007) ("monopsony power is market power on the buy side of the market ... and is sometimes colloquially called a 'buyer's monopoly.' "). 206 in re ncaa i-a walk-on football players litigation, 398 f. supp.2d 1144, (w.d. wash. 2005). 207 id. at 1150. 208 id. at 1149 (citing u.s. v. brown univ., 5 f.3d 658, 667 (3d cir. 1993). 2013 605 indiana health law review there were no reasonable substitutes for student-athletes who desired to participate at the highest level football competition while simultaneously seeking a baccalaureate degree. 209 the court found, "[t]he fact that [ncaa football] is a single product market [was] not fatal to plaintiffs' claim."2 1 0 the court concluded that the market alleged was a monopsony and reasoned that the ncaa regulation at issue could indeed substantially harm economic competition in that market.211 more recent cases have also found that "since the ncaa is the only purchaser of student athletic labor," the regulations promulgated by the association may in fact operate as an exercise of monopsony market power.212 3. the procompetitive presumption and the studentathlete labor market ncaa i-a walk-on football players stands for the principle that in the context of engaging student-athletes to participate in ncaa sponsored athletics, the ncaa acts as a consumer and the student-athletes as a supplier. this does not lead to the conclusion that all ncaa regulations that restrict student-athletes are volatile of the antitrust laws. indeed, it appears that the supreme court in board of regents approved a procompetitive presumption for certain ncaa regulations. "ncaa bylaws that 'fit into the same mold' as those discussed in board ofregents [may be found] to be procompetitive 'in the twinkling of an eye,' that is, at the motion-to-dismiss stage."2 13 a. the procompetitive presumption the recent case of agnew v. ncaa expressly demarcated which regulations are to be presumed procompetitive and 209 id. at 1150. 210 id. 211 id. at 1151. 212 agnew v. nat'l collegiate athletic ass'n, 683 f.3d 328, 337 n.3 (7th cir. 2012) ("this appears to be a clear monopsony case, since the ncaa is the only purchaser of student athletic labor."). 213 id. at 341 (quoting board ofregents, 468 u.s. at 110 n. 39). 606 vol. 10:2 ncaa student-atiletf health care those that are not based upon the commercial nature of the regulation at issue. the court elaborated on the scope of the procompetitive presumption: [when an ncaa bylaw is clearly meant to help maintain the "revered tradition of amateurism in college sports" or the "preservation of the student-athlete in higher education," the bylaw will be presumed procompetitive, since we must give the ncaa "ample latitude to play that role." but if a regulation is not, on its face, helping to ''preserve a tradition that might otherwise die," either a more searching rule of reason analysis will be necessary to convince us of its procompetitive or anticompetitive nature, or a quick look at the rule will obviously illustrate its anticompetitiveness. 214 the agnew court explained that ncaa regulations regarding student-athlete eligibility are precisely the type of regulations to which the procompetitive presumption applies: beyond the obvious fact that the supreme court explicitly mentioned eligibility rules as a type that 'fit[s] into the same mold' as other procompetitive rules, they are clearly necessary to preserve amateurism and the student-athlete in college [athletics]. indeed, they define what it means to be an amateur or a student-athlete, and are therefore essential to the very existence of the product of college [athletics].215 the court cited support for applying the procompetitive presumption to eligibility rules from other jurisdictions. the court of appeals for the third circuit held in smith v. 214 id. at 343 (quoting board ofregents, 468 u.s. at 120.). 215 id. at 343. 6072013 indiana health law review ncaa that the sherman act does not apply to ncaa eligibility rules because those rules are not related to the ncaa's commercial interest. 216 the smith court also found that even if the eligibility rules were commercial, they would nonetheless fail a rule of reason analysis because they "allow for the survival of the product, amateur sports, and allow for an even playing field," making them procompetitive. 217 additionally, in mccormack v. ncaa, the court of appeals for the fifth circuit, while not holding that eligibility rules are noncommercial in nature, ruled that the eligibility rule at issue (bylaw restricting the acceptance of benefits by student-athletes) survived rule of reason analysis because the rule allowed for the preservation of amateurism in college football.218 the consistent reasoning of courts faced with challenged to ncaa eligibility rules underscores that the procompetitive presumption will apply to eligibility rules because the ncaa must be able to rule who may and may not participate in their events or else there will be no means to differentiate college athletics from professional sports. without eligibility rules, the ncaa will not be able to define amateurism or enforce the standards of amateurism that prevent ncaa athletics from becoming a minor league sports organization. financial aid rules, in comparison, do not receive the benefit of the procompetitive presumption. "[flinancial aid rules do not always assist in the preservation of amateurism or the existence of student-athletes, so the regulations . . . cannot be presumptively procompetitive simply because they relate to financial aid."2 1 9 the agnew court found that the financial aid rules at issue in that case, the bylaws restricting athletics grant-in-aid offers to only one-year terms and limiting the number of athletics grants216 smith v. nat'l collegiate athletic ass'n, 139 f.3d 180, 185 (3d cir. 1998), vacated on other grounds nat'l collegiate athletic ass'n v. smith, 525 u.s. 459 (1999). see also gaines v. ncaa, 746 f.supp. 738, 743-44 (m.d. tenn. 1990), which reached the same conclusion. 217 smith v. ncaa, 139 f.3d at 187. 218 mccormack v. nat'l collegiate athletic ass'n, 845 f.2d 1338, 1344-45 (5th cir. 1988). 219 agnew v. ncaa, 683 f.3d at 345 (7th cir. 2012). 608 vol. 10:2 ncaa student-athle i[ heal h icari in-aid that each institution may award per sport, were "not directly related to the separation of amateur athletics from pay-for-play athletics . .. [nor [did] they help preserve the existence of the student-athlete."2 2 0 rather, the court felt that the bylaws were more likely "aimed at containing university costs, not preserving the product of college football."221 plaintiffs had not alleged that ncaa regulations at issue restricted student-athlete from realizing benefits beyond than those allowed within the ncaa amateurism model, but rather that the regulations operated to reduce benefits to a point below a level that was already permissible within the bounds of amateurism.222 the court found that "[ilt is not until payment above and beyond educational costs is received that a player is considered a 'paid athlete.' "223 therefore, financial aid rules that are not themselves eligibility rules (such as rules that limit financial aid to levels within the bounds of amateurism, i.e., the cost of attendance) cannot be presumptively assumed to promote amateurism. while it is possible that financial aid regulations may promote competitive equity and therefore be procompetitive, that determination cannot be made without a more probing antitrust analysis. b. student-athlete labor market beyond the discussion of the procompetitive presumption, the agnew court expressly recognized a labor market for student-athletes as "a cognizable market under the sherman act."2 2 4 the district court had held that a player labor market "fails as a matter of law because the seventh circuit has already rejected the idea of a labor market in the amateur college sports context."225 the district court based this conclusion on the seventh circuit's 220 id. 221 id. at 344. 222 id. at 332-333. 223 id. at 344. 224 id. at 346. 225 agnew v. nat'l collegiate athletic ass'n, 2011 u.s. dist. lexis 98744, at *23-24 (s.d. ind., 2011), affd, 683 f.3d 328 (7th cir. 2012). 6092013 indiana health law review two-to-one decision in banks v. ncaa nearly two decades earlier. 226 banks rejected a private antitrust challenge to the ncaa's "no-draft and no-agent rules" by a player declared ineligible after signing a representation agreement with an agent and taking part in the nfl draft. in banks, the majority disagreed with the dissent's characterization of the ncaa member institutions as "purchasers of labor" because "the operation of the ncaa eligibility and recruiting requirements prohibits member colleges from engaging in price competition for players."2 2 7 pervasive throughout the banks majority and dissenting opinions are references to the poorly drafted pleadings by the plaintiff.228 both the majority and the dissent address the lack of an explicitly defined market. 229 indeed, the majority even states that the plaintiff "might possibly have been able to allege an anti-competitive impact on a relevant market through a more carefully drafted complaint," however the court remained reluctant to essentially redraft the complaint for the plaintiff during appellate review. 230 the court of appeals for the seventh circuit upheld the dismissal in large part based upon plaintiffs inarticulate allegations. 231 the banks court's finding that a player labor market failed under the facts as alleged was a secondary barrier that the plaintiff could not overcome; it did not make allegations of a player labor market per se invalid as a matter of law in all antitrust challenges to ncaa regulations as judge magnus-stinson acquiesced to find at the district court level in agnew. 2 3 2 226 banks v. nat'l collegiate athletic ass'n, 977 f.2d 1081 (7th cir. 1992). 227 id. at 1091. 228 id. at 1088. ("[rlegardless of how charitably the complaint is read, it has failed to define an anti-competitive effect of the alleged restraints on the markets."). 229 id. at 1094 (flaum, j., dissenting) ("granted, the complaint was drafted somewhat inelegantly, but i nonetheless believe that it defines a market and describes how the ncaa rules harm competition in that market."). 230 id (majority opinion). 231 id 232 agnew, 2011 u.s. dist. lexis 98744, at *23 ("as the ncaa points out, the seventh circuit, in upholding the grant of a motion to 610 vol. 10:2 ncaa student-athlete health car; 6 in context, the banks court declined to find the ncaa member institutions were "purchasers of labor" in openmarket competition with each other for player talent in the relevant market. the institutions, by adhering to the "nodraft and no-agent rules," did not restrict competition in the student-athlete labor market even though the rule limited the potential value of grant-in-aid awards. key to the court's conclusion was the fact that "the value of the [athletic] scholarship is based upon the school's tuition and room and board, not by the supply and demand of players."233 the court implicitly reasoned that the "no-draft and no-agent rules" were not naked restraints on competition between the member institutions as the plaintiff implicitly alleged because the rules serve a legitimate purpose of maintaining amateurism in ncaa athletics, a valid procompetitive justification.234 any reduction in the potential financial value of a grant-in-aid alleged to be lost through the operation of the "no-draft and no-agent rules" was ancillary to the purpose of the regulations to maintain a product distinct from professional sports. that purpose would be significantly harmed absent the challenged restrictions. the regulations were specifically tailored to establish a sports league distinct from professional sports and the requirement that member institutions abide by the regulation did not unreasonably restrain the commercial relationship between member institutions and student-athletes. the loss of the potential increase in grant-in-aid value did not outweigh the ncaa objective to maintain a less commercialized athletic product. greater anti-competitive effects were required to be alleged for the complaint to survive dismissal. at most, one can draw the conclusion from banks that when an antitrust challenge alleges a student-athlete labor market is dismiss, has already rejected the claim that ncaa member schools could be purchasers of labor because the ncaa eligibility and recruiting requirements 'prohibit member colleges from engaging in price competition for players.' ") (quoting banks, 977 f.2d at 1091), affd, 683 f.3d 328 (7th cir. 2012). 233 banks, 977 f.2d at 1091. 234 id. ("elimination of the no-draft and no-agent rules would fly in the face of the ncaa's amateurism requirements.") 2013 611 indiana health law review unreasonably restrained from realizing financial value greater than that due to an amateur, that market fails. 2 35 the procompetitive presumption standard is consistent with this conclusion. regardless, the court of appeals for the seventh circuit specifically rejected the argument that student-athletes are not a labor market for the reasons relied upon by the district court. judge flaum expressed two reasons why the argument fails. "first, the only reason that colleges do not engage in price competition for student-athletes is that other ncaa bylaws prevent them from doing so. . . . [and s]econd, colleges do, in fact, compete for student-athletes, though the price they pay involves in-kind benefits as opposed to cash."2 3 6 this establishes that financial aid benefits are commercial and that student-athletes, by providing athletic services in return for financial aid benefits, are engaged in commerce. ncaa financial aid regulations that restrict the market for student-athlete labor services so that student-athletes cannot efficiently allocate their athletic talents in exchange for benefits within the bounds of amateurism (i.e., grants-in-aid) do not conform to the mandate of the sherman act. otherwise, ncaa regulations can operate to reduce all student-athlete benefits for the sake of increased profits for the member institutions and the student-athletes will have no adequate form of redress at law. 235 id. (the plaintiff, banks, failed to explicitly allege what anticompetitive effects were suffered due to the "no-draft and no-agent rule." it appears that plaintiff suggested that the rules restricted the value of a grant-in-aid award as well as the student-athlete's professional value by not allowing an athlete dissatisfied with their draft result to forego the professional leagues and return to college for further ncaa participation.); see also mccormack v. ncaa, 845 f.2d 1338 (5th cir. 1988) (holding rules that restrict the source of studentathlete benefits and limit the amount of those benefits to cost-of attendance do not violate the sherman act); in re ncaa i-a walk-on football players litigation, 398 f. supp. 2d 1144, 1149 (w.d. wash. 2005) ("[clourts have . . . found the award of financial aid to college students to be 'trade or commerce' and therefore subject to the sherman act.") 236 agnew, 683 f.3d at 346-47. 612 vol. 10:2 ncaa student-athlete halth care unfortunately for the agnew plaintiffs, their lawyers did not allege that the ncaa regulations at issue restrained the student-athlete labor market. like their predecessor in banks, while they "might possibly have been able to allege an anti-competitive impact on a relevant market through a more carefully drafted complaint," the court refused to redraft their complaint during appellate review of a motion to dismiss.237 as the court explained, even though the regulations at issue were likely limitations on output and price and that the case was likely subject to quick-look rule of reason review, plaintiffs still bore "the burden of describing a relevant market on which the bylaws have had an anticompetitive effect." 2 38 the quick-look doctrine allows a plaintiff to reduce its initial burden when it can show that there is a horizontal agreement to fix prices or reduce output, but that showing will not be enough. specifically, in a case such as agnew, where the market is not obviously commercial, the court "believe[d] it is incumbent on the plaintiff to describe the rough contours of the relevant commercial market in which anticompetitive effects may be felt, even when a quick-look approach is all that is called for."23 9 it is not necessary that plaintiffs engage in a full market analysis and prove the exact measure of defendant's market power in that relevant market. yet, 237 id. at 347. ("unfortunately for plaintiffs, nothing resembling a discussion of a relevant market for student-athlete labor can be found in the amended complaint. indeed, the word labor is wholly absent. plaintiffs claim that they 'allege[d] that there was 'no practical alternative' available for students wishing to pursue an education in exchange for their playing ability,' but the paragraph that they cite to in their amended complaint explains the lack of 'practical alternatives' for colleges wanting to field teams outside of the ncaa's framework, not the lack of 'practical alternatives' for student-athletes. plaintiffs appear to have made the strategic decision to forgo identifying a specific relevant market. whatever the reasons for that strategic decision, they cannot now offer post hoc arguments attempting to illustrate a buried market allegation. . . . by our count, plaintiffs had three opportunities to identify a relevant market in which the ncaa allegedly committed violations of the sherman act."). 238 id. at 337. 239 id. at 345. 6132013 indiana health law review [tihe entire point of the sherman act is to protect competition in a commercial arena; without a commercial market, the goals of the sherman act have no place. if a plaintiff can show that a defendant has engaged in naked restrictions on price or output, he can dispense with any showing of market power until a procompetitive justification is shown but the existence of a relevant market cannot be dispensed with altogether. 240 simply put, it appears that plaintiffs' counsel did not understand the full implications of the precedent regarding the quick-look doctrine relating to ncaa regulations found in board ofregents and law.2 4 1 240 id. at 337. 241 id. (the agnew court explained that despite a reduced burden on the plaintiff under a quick-look rule of reason analysis, a relevant market must still exist, explaining that: the supreme court, in board of regents, stated that 'when there is an agreement not to compete in terms of price or output, no elaborate industry analysis is required,' and 'naked restraint[s] on price and output require[ i some competitive justification even in the absence of a detailed market analysis.' "); see also la w v. ncaa ('under a quick look rule of reason analysis, anticompetitive effect is established, even without a determination of the relevant market, where the plaintiff shows that a horizontal agreement to fix prices exists... out of context, while these quotations seem to support plaintiffs' view of the quick-look doctrine, they are misleading. the quotes from board of regents and law are not referring to the need for a relevant market to exist, but rather to the plaintiffs burden of showing that an agreement had anticompetitive effects on a particular market. . . . the quick-look doctrine permits plaintiffs to forego any strict showing of market power, and thus a specific definition of the relevant market. . .. this does not mean, however, that there need not be a relevant market on which actions have an anticompetitive effect.) (alterations in original) (citations omitted). 614 vol. 10:2 ncaa student-athlete health car 5 c. public policy concerns the list of parties concerned about the effects of ncaa regulations on student-athlete well-being has grown significantly over the last several years, recently drawing the attention of state and federal government officials.242 in january of 2012, ncpa model legislation was introduced by state representative william crawford in indiana, which is intended to serve as a student-athlete bill of rights.243 the legislation aims to "guarantee college student-athletes basic protections, require colleges with lucrative tv revenues to pay for its student-athletes' sports-related medical expenses, and invests in increasing graduation rates among football and basketball players and more."2 4 4 crawford expressed his belief "that this an important piece of legislation that enhances the mission and mandate of state universities in regards to educating student athletes. this bill offers safety and education protections for student athletes that generate significant income for state supported universities."24 5 other state officials have articulated similar sentiments. california state senator alex padilla said he is committed to introducing similar legislation in california. 246 ohio state representative clayton luckie also introduced legislation in january 2012 which aims to allow division i institutions to provide up to an $8,000 stipend to student-athletes. 247 unfortunately, for 242 press release, nat'l college players ass'n, california and indiana lawmakers to push athletes bill of rights (jan. 9, 2012), available at http://ncpanow.org/releasesadvisories?id=0020; associated press, congressman rush compares ncaa to mafia, thegrio.com, (nov. 1, 2011), http://www.thegrio.com/news/congressman-rushcompares-ncaa-to-mafia.php. 243 press release, nat'l college players ass'n, california and indiana lawmakers to push athletes bill of rights (jan. 9, 2012), available athttp://ncpanow.org/releasesadvisories?id=0020. 244 id 245 id. 246 id. 247 jim siegel & todd jones, bill proposes $8,000 stipend for athletes, columbus dispatch (jan. 13, 2012), http://www.dispatch. com/content/stories/ocal/2012/01/13/bill-proposes-8000-stipend-forathletes.html 6152013 indiana health law review constitutional reasons, even if these state-level bills were enacted, they would likely not have any effect on the national regulations of the ncaa. still, they demonstrate the discomfort felt by many that ncaa regulations continue to disregard the rights of student-athletes. even at the federal level, illinois representative bobby rush recently compared the ncaa to the mafia, stating his opinion that the ncaa is "one of the most vicious, most ruthless organizations ever created by mankind," at a forum examining the impact of scandals in college sports. 248 these sentiments demonstrate that despite the innumerable positive aspects of ncaa athletics, there still remains the widely held reservation that the association and the member institutions ignore the main labor force so as to increase their own profit margins. these threats of external controls imposed on the ncaa should stand as a clear sign to the association, the athletic conferences, and the member institutions that the mode of operation must change. public policy concerns are continuing to side in favor of greater student-athlete benefits and the potential for external legislative and/or judicial decisions that follow this policy trend could undermine the autonomy of the ncaa. v. assessing the merits of ncaa health care insurance reform it is uncertain how many institutions provide studentathletes with health care coverage for injuries related to athletic participation. nor is it certain what level of coverage is offered or to which student-athletes it is available. in 2008, the ncpa sent requests to all division i member institutions seeking disclosure of "key medical policies that can affect . . . student athletes."249 the purpose 248 associated press, congressman rush compares ncaa to mafia, thegrio.com, (nov. 1, 2011), http://www.thegrio.com/news/ congressman-rush-compares-ncaa-to-mafia.php (noting that the congressman's comments were made following accounts from two mothers of former student-athletes who complained about how injuries sustained by their children were handled by the respective institutions). 249 nat'l college players ass'n, college medical policy search (database), available at http://apps.ncpanow.org/policy-search.asp. 616 vol. 10:2 ncaa student-athlete health care of the request was to provide prospective student-athletes with important information regarding the medical policies of the institutions that might attempt to recruit their athletic services. the ncpa graded all member institutions on a scale from a+ to f based upon the institutions' responses to the requests. 250 "about 90% of all division i athletic programs refused to disclose the medical policies requested by the ncpa."251 252 however, searches of public records will reveal relevant data for public institutions and suggest that some institutions do provide health care coverage for varsity student-athletes. the same year as the ncpa request, the university of iowa received approximately 4,200 medical bills for its varsity studentathletes and paid $776,454 on behalf of those athletes.253 nevertheless, in the absence of labor law protection, the unwillingness of some ncaa member institutions to cooperate with the ncpa regarding the 2008 survey, and their opposition to ncaa regulatory increases in student250 nat'l college players ass'n, college medical policy search (database), available at http://apps.ncpanow.org/policy-search.asp. (the ncpa does not present the searcher with any rubric for the grading scale except that failing to respond resulted in the grade of f for the institution). 251 press release, nat'l college players ass'n, ncpa exposes medical policies at d-1 ncaa colleges grading system will help recruits avoid abuse (nov. 6, 2008), available at http://www.ncpanow. org/releasesadvisories?id=0007. 252 i have conducted a search of all big ten institutions (twelve, in total) in the database and only purdue university responded to the request. a link to the one-page response from athletic director morgan burke can be found at http://apps.ncpanow.org/policy-detail. asp?gradingid=173. however, purdue's response did not answer the survey questions directly and the ncpa was apparently unable to grade the institution's medical policies in accordance with their grading scale. nevertheless, mr. burke, does disclose some of the medical practices of the institution's athletics department, including that they employ a number of full-time medical personnel for student-athletes. a search of all southeastern conference institutions (fourteen, in total) reveals that only the university of florida responded to the request, receiving the grade of d for the institution's medical policies. twenty-four institutions did receive grades of aor better, including two institutions from bcs conferences (university of oregon and west virginia university). 253 peterson, supra note 6 (noting the information was acquired by documents obtained through a iowa public records law request). 2013 617 indiana health law review athlete in-kind benefits raises concerns whether the wellbeing of student-athletes is adequately protected. it is best to address the issue of mandated health care coverage for ncaa student-athletes in very basic terms. initially, continued justifications for limiting the benefits received by student-athletes appear more absurd with each subsequent legal challenge. this was firmly demonstrated by the stern disregard for the argument that studentathletes are not engaged in labor by the agnew court. amateurism, while a sound concern to be addressed by ncaa regulations, is not an ironclad justification for limiting student-athlete benefits at a monopsony level of compensation. dean gary roberts illustrated the absurdity well, explaining that should: [a]ll the members of the widget industry . . . agree to pay their employees a monopsony wage rather than a market wage, also agree to require each employee to spend a brief time every day at work studying transcendental meditation, and then justify the agreement on the ground that it enabled them to produce the unique product known as widgets made by students of transcendental meditation . . . [it] surely would not be lawful . . . .2 5 4 eventually, the question will boil down to whether a multi-billion dollar industry that generates its revenue from high intensity performance productions and compensates the performer class solely with in-kind benefits may unilaterally restrict those benefits below the full cost of participation imposed on the performers (a large portion of that cost also set unilaterally by those in control of the industry). this question strikes at the core of both labor policy and antitrust law potentially hard enough to disrupt the status quo. it seems unwise for the ncaa to risk regulatory autonomy on precedent from a generation past when the decision of a court had far less potential for 254 gary r. roberts, the ncaa, antitrust, and consumer welfare, 70 tul. l. rev. 2631, 2660 (1996). 618 vol. 10:2 ncaa student-athlete health care economic impact. in 2011, ncaa sports generated an estimated $11.4 billion, 255 an amount greater than any professional sports league in the north america. 256 rather than take an adversarial approach, it is likely the best idea to improve student-athlete well-being standards through normal, yet progressive, ncaa regulatory means. following agnew, the potential for antitrust liability is quite real. current ncaa regulations likely in fact operate to restrict competition from non-"major conference" member institutions to the advantage of the "major conference" members and to the detriment of the majority of the student-athlete labor market. the current distribution measures for ncaa revenues award the bulk of the money to the "major conferences," while essentially giving division ii and division iii member institutions no support whatsoever. it seems as though an industry that relies on the argument that its member institutions do not compete with each other economically in the player labor market should therefore aim to ensure that every member has adequate financial resources to provide the basic necessities for those student-athletes, especially when the governing body of that industry was founded for the purpose of promoting health and safety. the current ncaa bylaws requiring that member institutions certify health care insurance to cover medical expenses from athletically related injuries for all studentathletes may upset the antitrust laws. the sherman act declares illegal "ie]very contract, combination . . . , or conspiracy, in restraint of trade or commerce" in interstate commerce. 257 "[i1n restraint of trade" has been interpreted as unreasonable restraint of trade.258 ncaa bylaws, as well 255 finances revenue, ncaa.org, http://www.ncaa.org/wps/wcm/ connect/public/ncaa/finances/revenue (last updated feb. 13, 2013) (click "is ncaa revenue different from money generated by member conferences and institutions?"). 256 w.r. hambrecht & co., the u.s. professional sports market & franchise value report 22 (2012), available at http://wrhambrecht.com/pdf/sportsmarketreport_2012.pdf. 257 15 u.s.c.a. § 1 (west 2004). 258 see texaco inc. v. dagher, 547 u.s. 1, 5 (2006) (noting that "this court has not taken a literal approach to this language, recognizing, 6192013 indiana health law review as the revenue distribution formula, are agreements among the membership subject to the sherman act. now, following the express recognition of a student-athlete labor market by the seventh circuit, the in-kind benefits that studentathletes receive in exchange for their athletic services are commerce. if the health care coverage certification bylaw and the ncaa revenue distribution formula work in combination to unreasonably restrain the in-kind benefits received by student-athletes, then the ncaa membership have an agreement in violation of the antitrust laws. the initial step in this inquiry will be for the complaining student-athlete to allege a restraint of trade in a relevant market. the relevant market should be pled as a studentathlete(s) performing athletic-labor services in exchange for in-kind benefits from an ncaa member institution(s) in the collegiate sports market in the united states. the restraint on that market will involve a much more detailed pleading. beginning from the premise that ncaa eligibility rules are presumed procompetitive, 259 it appears that the health care coverage certification rule is an eligibility rule. student-athletes are not eligible to participate in ncaa events until the member institution certifies that the student-athlete has health care insurance coverage. it may be possible to rebut this presumption. the procompetitive presumption applies when the ncaa bylaw at issue "help[s] maintain the 'revered tradition of amateurism in college sports,' or the 'preservation of the student-athlete in higher education."260 the health care coverage certification rule does not on its face help maintain amateurism, nor is it clear that it preserves the student-athlete in higher education. rather, it increases the cost of participation in ncaa athletics for student-athletes, a cost that is not adequately calculated in the cost of attendance formula for instead that congress intended to outlaw only unreasonable restraints.") (emphasis in original). 259 agnew v. ncaa, 683 f.3d 328, 342-43 (7th cir. 2012). 260 id 620 vol. 10:2 ncaa studint-atii.ete healtii care grant-in-aid purposes. 261 the health care coverage certification bylaw, therefore, decreases the net value of any grant-in-aid award received by a student-athlete. it will be difficult to prove that by increasing the cost of participation for student-athletes that the health care coverage certification rule increases the student-athletes' cost of attendance. concededly, student-athletes can attend the university at a lower cost of attendance by not participating in intercollegiate athletics. however, if the relevant market is defined as student-athletes then the cost of participation is the pertinent amount. student-athletes are pursuing an education; however they are also seeking to simultaneously participate in high-level athletic competition. they are not in the same relevant market as other collegiate students who are not receiving in-kind benefits for athletic services. it is imperative that the market definition excludes students that are not studentathletes. the health care coverage certification bylaw is more appropriately viewed as a hybrid eligibility-financial aid rule, especially when viewed in combination with bylaw 3.2.4.8.1(c) that allows for member institutions to voluntarily provide health care coverage for the studentathlete.262 initially, it is interesting to note that bylaw 3.2.4.8.1(c) possibly allows for benefits in excess of the cost of attendance for student athletes, as institutions do not calculate health care coverage in the cost of attendance. this raises questions about how amateurism is in fact defined by the ncaa. regardless, the additional benefit to 261 see generally division i manual ("§15.02.2.1. calculation of cost of attendance. an institution must calculate the cost of attendance for student-athletes in accordance with the cost-of-attendance policies and procedures that are used for students in general."); see also office of student financial aid, cost of attendance, indiana university, http://www.indiana.edu/-sfa/receiving/cost.html (last visited mar. 1, 2013) (showing that indiana university calculates cost of attendance to include: tuition and fees; room and board; books and supplies; transportation; and personal categories; and that the personal category is estimated at $2,522, an amount that cannot include the cost of health care insurance coverage, especially in light of the health insurance offered by the school exceeds that amount). 262 see division i nianual. 6212013 indiana health law review student-athletes in the form of health care coverage is a form of financial aid, and therefore, the bylaw is a financial aid rule. financial aid rules do not receive the benefit of the procompetitive presumption. studentathletes that receive health care coverage from the member institutions receive a net increase in the value of their grant-in-aid awards. allowing member institutions to voluntarily provide health care coverage to student-athletes does not appear to be a problem at first blush. however, in combination with the ncaa revenue distribution formula, as agreed upon by the membership, the bylaw begins to appear more pernicious. the membership has agreed that studentathletes must be certified as having health care insurance coverage before the student-athletes can compete in ncaa events. member institutions may provide the health care coverage for the student-athletes. the revenue distribution formula rewards less than seven-percent of the membership with thirty eight-percent of the revenue. it is highly unlikely that under the current revenue distribution formula, the remaining member institutions can afford to provide health care coverage for student-athletes. bylaw 3.2.4.8.1(c), therefore, is a cost-cutting measure operating in practice as a monopsony price fix that sets student-athlete benefits below the actual cost of participation. the legitimate procompetitive justifications that the ncaa could raise in rebuttal to these arguments should fail. the bylaws and revenue distribution formula do not operate to preserve amateurism. therefore, the last viable argument for the ncaa would be that bylaw 3.2.4.8.1(c) maintains competitive equity by allowing member institutions with less revenue to remain economically viable. that argument should also fail. the revenue distribution formula and bylaw 3.2.4.8.1(c) disrupt competitive equity. the membership controls the revenue distribution formula and continues to promulgate a formula that rewards historically wealthy schools with more money while underfunding the historically poorer member institutions. this in turn creates greater disparity in the financial burdens that fall on student-athletes, resulting in a net increase in benefits (in excess of cost of attendance) for 622 vol. 10:2 ncaa student-athleti ih ealt i car f2 some and a net decrease in benefits for others. when the agreement by the membership results in higher profits for some members at the expense of the majority of the student-athlete labor market, that agreement does not have a procompetitive justification. nor should the ncaa be able to argue that the revenue distribution model rewards the unequal contributions of the member institutions (such as their success in the ncaa men's basketball championship) because student-athlete talent should not be a factor considered in the distribution model. ncaa athletics are not professionalized sports. the student-athletes participate as an "avocation" and as a result all should benefit equally. the main purpose of attending an institution of higher education is to obtain an education, not to participate in athletics. a student-athlete's decision to attend an institution should not be more heavily influenced by the potential for student-athlete in-kind benefits rather than potential opportunities for academic and professional development like that of others seeking a college education. the revenue distribution formula limits the ability of member institutions to provide full health care coverage to student-athletes, which in turn impacts the student-athletes choice of educational institutions by imposing potentially higher participation costs that reduce the value of a student-athlete's financial aid award and other in-kind benefits. that does not fit with the ncaa's core value of encouraging the pursuit of academic excellence. in practice, this situation encourages institutions that are unable to provide coverage for student-athlete injuries to hide that information from recruits as much as possible. member institutions do in fact compete with one another for student-athlete services during the recruiting process, and information related to the institutions ability to provide for a student-athlete in the event she should suffer an injury certainly plays a significant role in that student-athlete's decision regarding what institution to attend. injuries are a part of athletics. a student-athlete should not suffer because her conference, and therefore her institution, receives a lesser share of the $11.4 billion generated by the 2013 623 indiana health law review industry in which she readily participates and represents with as much fervor as an athlete at a more financially stable institution. the supreme court has impliedly stated it is permissible for the ncaa to regulate and dictate how the member institutions use the revenues generated from athletics. 263 ncaa regulations aimed to improve competitive equity by mandating member institutions to provide for health care coverage for all student-athletes will not violate antitrust principles and will further provide student-athletes with more appropriate benefits for their services, reducing concerns that ncaa regulations operate to reduce competition for student-athlete labor services. the lack of such a mandate continues to raise antitrust concerns that ncaa regulations fix student-athlete benefits below market value and stifle competition between member institutions for student-athlete labor services. the costs associated with instituting a mandate for full health care coverage for all student-athletes are likely far less than the costs associated with defending antitrust and other legal actions or lobbying legislative bodies in order to retain full autonomy. the most obvious suggestion for financing full health care coverage for all student-athletes appears to be redirecting a portion of men's basketball championship and the new college football playoff television revenues into a student-athlete health care coverage fund and other funds that address scholarship -shortfall problems.264 in addition to mandating full health care coverage, the association should further mandate that all member institutions participate in the group basic medical program in order to more effectively control expenses. 265 beyond the group 263 nat'l collegiate athletic ass'n v. board of regents of the univ. of oklahoma, 468 u.s. 85, 119 (1984). 264 see aware of new timoney, players petition ncaa to invest in reform this week, ncpanow.org (oct. 25, 2011), http://www.ncpanow.org/newsarticles?id=0034. 265 see generally student athlete benefits, ncaa.org, http://ncaa.org/wps/wcm/connect/public/ncaa/finances/finances+student+ athlete+benefits (last visited mar. 1, 2013) ( defining the group basic medical program as "[a] program that covers intercollegiate sports624 vol. 10:2 ncaa student-athletf i ifalth care basic medical program, institutions should attempt to design health care insurance policies that cover their student-athletes with "aggregate deductibles." 266 these policies would allow for institutions to reach certain thresholds of expected claims expenses before requiring additional premium payments. 267 it also seems appropriate to mandate increased revenue sharing between member institutions to help fund institutional grants-in-aid and health care coverage, and institute greater control measures regarding the upward spiral of football and men's basketball coaching salaries (such as requiring member institutions that eclipse certain salary amounts for coaches to provide additional grants-in-aid and other benefits for studentathletes participating in non-revenue generating sports). these measures might provide the economic means to finance more appropriate student-athlete benefits. these measures must, of course, be adopted by the membership itself. convincing several powerful member institutions to reduce the size of their slice of the pie may be difficult, but without such a sacrifice many continue to lose for the benefit of a few. the effects of these measures must not simply be viewed in the short-term. the potential increase in competitive equity and league-wide stability should increase the overall revenue generated by ncaa athletics. increased student-athlete benefits at institutions that are currently unable to offer benefits such as health care coverage for all ailments may draw stronger athletic talent to those institutions, improving league parity and drawing greater fan support. further, increased benefits may inspire the marginal professional-level athlete to related injuries and institution below the catastrophic insurance deductible of $90,000 per injury. the program is intended to provide member institution the tools and resources necessary to control costs and reduce expenses related to athletics injuries, including a reasonable insurance solution, risk-management strategies, cost-containment solutions and administrative service."). 266 libby sander, at many colleges, no health insurance means no playing time, chronicle of higher education (jan. 13, 2011, 2:29 pm), http://chmnide.com/blogplayersat-many-leges-no-healthinsurance-means-noplayinglime/28004 267 id. 6252013 indiana health law review remain eligible for ncaa athletics longer, improving both the student-athlete's education and athletic abilities, and the overall quality of ncaa competition. as another means of financial management, some consideration should be given to instituting requisite benchmarks student-athletes must meet to be eligible for certain benefits. possible benchmarks could include linking awards to academic achievement, limiting the awards to upperclassmen (potentially encouraging studentathletes to remain in school longer), rewarding community service, or possibly even rewarding outstanding athletic performance. these considerations affect more than just division i student-athletes. the potential for an injury is just as great in division ii or iii athletic events. any potential regulatory reform must consider not only the revenue generating student-athletes, even though they may produce a greater share of the means, but must also account for the nonrevenue generating student-athletes that make up the vast majority of the participants in ncaa competitions. vi. conclusion the ncaa is currently faced with a massive shift in public opinion regarding the nature and effects of its regulatory structure. this is the result of the enormous revenues now generated by ncaa athletics, specifically football and basketball. as revenues increase, player benefits have remained stagnant for more than half a century. student-athletes believe when they receive a "full ride" they will avoid the worry about money and the financial hardships common among undergraduate students. instead, they are left to discover, often without much warning that they will live in poverty like all other students, yet will be required to perform services for the institution that other students are not and, in some instances, their services will contribute to generating millions of dollars in revenues for the institution. it is unjust to continue this system of operation. in what other industry is it legal to require a labor force to pay the benefiting institution for the opportunity to generate annual 626 vol. 10:2 ncaa student-atilet ihealtt i care revenues in excess of $11.4 billion, and in turn that industry forbids that labor force from receiving even their baseline costs of participation? ncaa regulations are necessary if academics are to remain the priority for amateur student-athletes. however, the current regulations fail to adequately promote studentathlete well-being and instead create a cynical atmosphere among the student-athletes and the general public. denying student-athletes benefits that do not offend amateurism encourages underhanded dealings and deemphasizes the core value of integrity and the mental development of the student-athletes. at a minimum, the ncaa must mandate that its institution provide student-athletes with full health care insurance coverage provided at no cost. studentathletes risk their health and well-being for the benefit of their institutions. they must receive adequate protection. 2013 627 why the common rule is hard to amend why the common rule is hard to amend barbara j. evans* abstract. ............................................. 366 i. introduction ................................. ..... 366 ii. summary of the 2011 proposal to amend the common rule ............................................. 371 a. summary of the anprm's reform agenda ... .... 372 b. existing and proposed consent provisions for data and biospecimens ................................ 375 iii. the substantive challenge of modernizing informed consent 380 requirements for data and biospecimens. ................................ .... 380 iv. finding an appropriate process to modernize the common rule .............................. 390 a. sources of hhs's authority to amend the common rule ............................. ....... 391 b. why congress constrained hhs's authority to set informed consent requirements...............394 1. intelligible principles to guide agency rulemaking.394 2. procedural formality to ensure an inclusive dialogue. ..................................... 399 3. substantive policy concerns ............. ..... 400 c. special legal status of the 1978 regulatory recommendations ............................. 403 d. why the common rule's consent provisions are hard to amend. ............................ ..... 406 v. conclusion ................................... .... 412 * professor of law; co-director, health law & policy institute; director, center on biotechnology & law, university of houston law center, bjevans@central.uh.edu. j.d., yale law school; m.s., ph.d. stanford university; post-doctoral fellow, the university of texas m.d. anderson cancer center. this research has been supported by the greenwall foundation and the university of houston law foundation. indiana health law review abstract information-based studies that use people's health data and biospecimens are set to play an important role in 21lstcentury biomedical discovery, public health, and healthcare system improvement. there is wide agreement that the common rule needs to be modernized to provide better protection for people whose data and biospecimens are used in such studies. unfortunately, the secretary of health and human services (hhs) is in the position of trying to keep the common rule up to date using authorities granted by an outdated statute. this article explores statutory constraints that appear to limit the secretary's authority to make some of the changes proposed in the july 2011 anrpm. some of the proposed revisions to the common rule seemingly would require legislative action to alter the secretary's rulemaking authority. this does not, however, mean that it will be impossible to modernize the common rule in the absence of legislative action. as noted at the end of this article, the secretary of hhs has significant discretion to make the common rule function better without amending the regulatory text itself. the common rule is hard to amend, but there are promising pathways for implementing improved policies within the framework of the existing regulation. skillful use of these other approaches may avoid the need for hasty regulatory amendments that may, in the end, prove unlawful. i. introduction studies of health data and biospecimens are poised to play a major role in 21st-century biomedical discovery and healthcare system improvement.' recent legislation 1 see, e.g., 21 u.s.c. § 355(o)(3)(d) (2012) (placing the u.s. food and drug administration under a requirement to consider the use of observational studies and determine that they would be "not sufficient," before the agency can order a postmarketing clinical drug trial); see also inst. of med., the learning healthcare system: workshop sum1viary 128, 130 (leighanne olsen et al. eds., 2007) [hereinafter iom learning healthcare] (discussing the growing use of observational methodologies); fred d. brenneman et al., outcomes research in 366 vol. 10.2 why the common rule is hard to amend expands the use of such studies in postmarketing drug safety surveillance2 and comparative effectiveness research. 3 "[c]linical data are the resource most crucial to healthcare progress," declared a recent institute of medicine report that considered the role of health data in research, public health, quality improvement, and program evaluation studies.4 methodologies that study existing data-including information derived from biospecimens-go by many names: informational5 studies, records6 research, surgery, 23 world j. surgery 1220 (1999) (discussing the growth of observational approaches after 1980); outcomes research fact sheet (2000), agency for healthcare research and quality, http://www.ahrq.gov/clinic/outfact.htm (last visited oct. 12, 2011) [hereinafter ahrq fact sheet]; rina hakimian & david korn, ownership and use of tissue specimens for research, 292 jama 2500, 2500 (2004) (noting the growing importance of research with biospecimens). 2 see barbara j. evans, seven pillars of a new evidentiary paradigm: the food, drug, and cosmetic act enters the genomic era, 85 notre dame l. rev. 419, 476-85 (2010) (discussing the food and drug administration's expanded authority to conduct active postmarketing drug safety surveillance, including observational (epidemiological) studies, under the food and drug administration amendments act of 2007, pub. l. no. 110-85, 121 stat. 823 (2007) (codified as amended in scattered sections of 21 u.s.c.) [hereinafter fdaaa]); efthimios parasidis, patients over politics: addressing legislative failure in the regulation of medical products, 2011 wis. l. rev. 929, 948-49 (2011). 3 see richard s. saver, health care reform's wild card: the uncertain effectiveness of comparative effectiveness research, 159 u. pa. l. rev. 2147 (2011) (discussing comparative effectiveness provisions of the american recovery and reinvestment act, pub. l. no. 111-5, 123 stat. 115 (2009) and the patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010)). 4 see, e.g., inst. of medicine, clinical data as the basic staple of health learning, creating and protecting a public good: workshop summary 1 (claudia grossmann et al. eds., 2010) [hereinafter iom, clinical data]. 5 barbara j. evans, much ado about data ownership, 25 harv. j.l. & tech. 69, 71 (2012). 6 see u.s. dep't of health, educ., & welfare, protection of human subjects, institutional review boards: report and recommendations of the national commission for the protection of human subjects of biomedical and behavioral research (1978) [hereinafter hew, 1978 report] (using the phrase "research using . . 3672013 indiana health law review observational7 studies, epidemiologic 8 studies, or information-based 9 research. by whatever name, these methodologies will play a prominent role alongside clinical research that was the mainstay of late-20th-century biomedical evidence generation. 10 a major task facing health lawyers and policymakers in the next quarter century is to adapt our nation's laws and regulations to this reality. the difficulty, of course, is to enable socially beneficial studies to move forward while preserving strong ethical and privacy protections for the people whose data and biospecimens are used. two important federal regulations affecting data and tissue access are the health insurance portability and accountability act of 1996 ("hipaa")11 privacy rule12 and the federal policy for the protection of human subjects, 13 or "common rule."14 there is records" to refer to studies that use existing medical data). 7 bengt d. furberg & curt d. furberg, evaluating clinical research: all that glitters is not gold 29-37 (2nd ed. 2007) (using the term "observational" to refer to methodologies that study data). 8 david casarett, jason karlawish, elizabeth andrews & arthur caplan, bioethical issues in pharmacoepidemiologic research 587, 588 (brian l. strom ed., 4th ed. 2005). 9 inst. of med., beyond the hipaa privacy rule: enhancing privacy, improving health through research 7 (sharyl j. nass, laura a. levit & lawrence 0. gostin eds., 2009) [hereinafter iom, privacy report], available at http://www.nap.edu/catalog/l2458.html (last visited mar. 22, 2013) (distinguishing "information-based" research from clinical research). 10 see, e.g., 21 u.s.c. § 355(o)(3)(d) (2012) (calling for the use of observational methodologies alongside clinical trials in regulating the safety of approved drugs); iom, clinical data, supra note 4; see also evans, supra note 2, at 431-50 (discussing methodological limitations of traditional randomized, controlled clinical trials and advantages of emerging informational study methodologies for the purpose of generating evidence of the safety of approved drugs). 11 health insurance portability and accountability act of 1996, pub. l. no. 104-191, 110 stat. 1936 (codified as amended in scattered sections of 18, 26, 29 and 42 u.s.c.). 12 45 c.f.r. pts. 160, 164. 13 see u.s. dep't of health & human servs., federal policy for the protection of human subjects ("common rule"), hhs.gov, http://www. hhs.gov/ohrp/humansubjects/commonrule/index.html (last visited mar. 18, 2013). 368 vol. 10.2 why the common rule is hard to amend widespread sentiment that these regulations are outdated and need to be modernized15 to accommodate this "epochal shift"16 in how biomedical evidence will be generated in the future. this regulatory modernization process offers an example of why the next quarter century of health law is likely to be more complicated-and a bit more legalistic-than "hl version 1.0" (that is, health law as it developed over the past four decades). a common task in first-generation health law was to perform normative legal analysis on a blank or nearly blank slate. health lawyers frequently found themselves working to design ethically appropriate policies for contexts where the existing law was silent or 14 id.; see also 45 c.f.r. §§ 46.101-46.124 (2010). 15 see hhs, human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators, 76 fed. reg. 44,512, 44,523, 44,525 (july 26, 2011) (to be codified at 45 c.f.r. pts. 46, 160, 164 and 21 c.f.r. pts. 50, 56) [hereinafter hhs, anprm] (noting in connection with a proposal to amend the common rule that "[c]ritics of the existing rules have observed that the current requirements for informed consent for future research with pre-existing data and biospecimens are confusing and consume substantial amounts of researchers' and [institutional review boards'] time and resources") ("[o]ther fundamental protections for research participants may be warranted beyond updating the requirements for independent review and informed consent currently provided by the common rule."); see also iom, privacy report, supra note 9, at 66 (discussing concerns that the privacy rule impedes beneficial access to data and biospecimens while also noting that many members of the public feel the regulation inadequately protects their privacy); william burman & robert daum, grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts, 49 clinical infectious diseases 328, 328 (2009) (noting that "the application of the health insurance portability and accountability act to research has overburdened institutional review boards (irbs), confused prospective research participants, and slowed research and increased its cost"); fred h. cate, protecting privacy in health research: the limits of individual choice, 98 calif. l. rev. 1765, 1797 (2010) (noting that "[clonsent requirements [of the existing regulations] not only impede health research, but may actually undermine privacy interests"). 16 barbara j. evans, institutional competence to balance privacy and competing values: the forgotten third prong of hipaa preemption analysis, 46 u.c. davis l. rev. 1175, 1184 (2013). 369'2013 indiana health law review mumbling. successful outcomes of these efforts included (to list just a few examples) the widespread adoption of advance directive statutes granting patients greater control of their end-of-life healthcare decision-making;1 7 the transformation of rudimentary, informal 1960s-era national institutes of health ethics policies18 into today's common rule; and the recognition of a greater federal responsibility to protect medical privacy and data security,19 two matters previously relegated to the inconsistencies of state law.2 0 when writing on a blank legal slate, one often encounters a striking convergence of bioethical and legal analysis. if the question is, "what should the legal rules be?" then grounding them in ethical principles is a reasonable approach, and normative legal and bioethical studies often resemble one another. in hl version 2.0health law as it is developing in the new century-scholars 17 see, e.g., rebecca dresser, symposium: precommitment theory in bioethics and constitutional law: bioethics: precommitment: a misguided strategy for securing death with dignity, 81 tex. l. rev 1823 (2003) (discussing the adoption of advance directive statutes in the 1990s and ethical and practical problems surrounding the use of advance directives). 18 see u.s. dep't of health & human servs., protection of human subjects, 39 fed. reg. 18,914 (may 30, 1974) (to be codified at 45 c.f.r. pt. 46) (tracing the common rule to an existing departmental policy set out in ch. 1 40 of the dhew grants administration manual). 19 see pub. l. no. 104-191, title ii, subtitle f (codified primarily in title 42, ch. 7 of the u.s. code, as "part c-administrative simplification" §§ 1320d 1320d-8) (authorizing the secretary of health and human services to promulgate various interrelated h[paa regulations). see, e.g., the hipaa privacy rule, 45 c.f.r. pts. 160, 164; u.s. dep't of health & human servs., off. of sec'y, health insurance reform: standards for electronic transactions: final rule, 65 fed. reg. 50312 (aug. 17, 2000) (to be codified at 45 c.f.r. pts. 160, 162); u.s. dep't of health & human servs., off. of sec'y, health insurance reform: security standards: final rule, 68 fed. reg. 8334 (feb. 20, 2003) (to be codified at 45 c.f.r. pts. 160, 162, 164). 20 see national committee on vital and health statistics subcommittee on privacy and confidentiality: hearing on implementation of the federal standards for privacy of individually identifiable health information § ii (oct. 30, 2002) (statement of joy l. pritts, senior counsel, health privacy project), available at http://www.ncvhs.hhs.gov/021030p6.htm (discussing states' efforts over many years to refine medical privacy standards and adapt them for changes in the healthcare industry). vol. 10. 2370 why the common rule is hard to amend less frequently will find themselves writing on a blank slate. identifying ethically appropriate policies remains just as important today as it always was but it is only one part of the health lawyer's job. sound policies, once identified, may have to be implemented on a cluttered slate-and the clutter includes old statutes that may have seemed an expedient way to proceed during the heady days of hl version 1. in addition to a clear head for bioethical analysis, hl version 2 requires basic lawyering. skillssuch as statutory construction and a tactical grasp of rulemaking procedure-with which to chisel out a space for good policy on a cluttered legal landscape. recent efforts to modernize the common rule display this phenomenon and this article uses them to demonstrate the point. amending the common rule presents two distinct subproblems. the first is to identify sound substantive policies in other words, to decide what the common rule's informed consent requirements ought to be. this first task is in many respects a normative bioethical inquiry that turns on concerns about respect for individual autonomy, the impact of data disclosures on dignitary interests of the individual, and the extent (if any) to which individuals should be called upon to sacrifice their own interests to serve the public good. the second sub-problem is more legal in nature. when stakeholders hold widely divergent views, who gets to set policy and what procedures must be followed when making these decisions? statutes are relevant insofar as they may define the process for debating and resolving the underlying bioethical dilemmas. the next quarter century of health law is strewn with problems that present bioethical dilemmas wrapped in statutory constraints. ii. summary of the 2011 proposal to amend the common rule in july 2011, the u.s. department of health and human services (hhs) office for human research protections (ohrp) published an advance notice of proposed 2013 371 indiana health law review rulemaking (anprm)21 that envisioned changes to the common rule. 22 the anprm was an optional, preliminary step that simply put the public on notice that the agency was considering the possibility of amending its regulations. this section summarizes the policy changes discussed in the anrpm and then compares its proposed consent scheme for data and biospecimens to the existing provisions of the common rule and hipaa privacy rule. a. summary of the anprm's reform agenda consistent with its preliminary nature, the anprm did not include specific, proposed regulatory text for public comment, as a true notice of proposed rulemaking would have done. instead, the anprm sketched a broad outline of possible reforms the agency was considering and sought public comment on 74 broad questions.23 the first item on the anprm's reform agenda was called "ensuring risk-based protections"24 and included several proposals, all aimed at achieving a better fit between how much risk a research project poses and how much regulatory oversight it receives. one of these proposals was to impose mandatory data security standards, possibly identical to the hipaa standards, 25 after which institutional review boards (irbs) no longer would be responsible for reviewing "informational risks" (risks to data security and privacy of research subjects).26 other proposals would clarify when expedited irb review is allowed and when continuing review is required.27 the anprm also proposed to replace the common rule's existing exemptions 28 with a new "excused" category of 21 hhs, anprm, supra note 15. 22 45 c.f.r. §§ 46.101-46.124 (2010). 23 see hhs, anrpm, supra note 15, at 44,517-29. 24 id. at 44,514-21. 25 id. at 44,515, col. 1. 26 id. at 44,515, col. 3 44,516, col. 1. 27 id. at 44,516, col. 1 44,518, col. 2. 28 see 45 c.f.r. § 46.101(b) (2010) (listing various exemptionsi.e., situations where activities are exempt from the common rule's requirements). 372 vol. 10.2 why the common rule is hard to amend research. 29 the common rule presently treats certain activities-including research with de-identified data and biospecimens30-as altogether exempt from the common rule's regulatory requirements. exempt activities require neither an irb review nor informed consent (although many institutions do, nevertheless, have their irbs oversee the threshold determination of whether an activity properly fits into one of the common rule's exemptions). the anprm's new category of excused research, like the existing exemptions, would not require irb review. 31 in some cases, however, excused research would require informed consent. 32 the anprm thus was proposing to add new consent requirements for studies that use de-identified data and specimens. 33 the second major item on the anprm's reform agenda was to streamline irb review of multisite studies. 34 hhs sought public comment on whether domestic sites in such studies should be able to designate a single "irb of record" to review the study in a centralized fashion on behalf of all participating sites.35 the third agenda item was to improve the informed consent process for all types of studies, including clinical research as well as informational research.36 these consent-related proposals included, for example, to simplify consent forms.37 these proposals also addressed, in a more general way than the anprm's earlier discussion of exempt research had done, the question of consent for data and biospecimens. 38 once again, the anprm proposed to 29 hhs, anprm, supra note 15, at 44,518, col. 2 44,521, col. 3. 30 45 c.f.r. § 46.101(b)(4). 31 hhs, anprm, supra note 15, at 44,518, col. 2. 32 id.; see also id. at 44,519, col. 2 44,520, col. 1. 33 see id. at 44,518-21, 44,527 tbl.1 (proposing to require consent for certain exempt uses of data and biospecimens that do not presently require consent under the common rule). 34 hhs, anprm, supra note 15, at 44,521-22. 35 id. at 44,522. 36 id. at 44,522 44,524. 37 id. at 44,523. 38 id. at 44,523 24. 373'2013 indiana health law review require consent in some circumstances where the existing common rule does not do so. 3 9 the anprm's fourth major agenda item was to reduce informational risks by strengthening data protections. 40 here, the anprm proposed to conform the common rule's definitions of certain terms, such as "identifiable" and "deidentified," to the hipaa privacy rule's definitions and to apply the hipaa security rule to research regulated by the common rule. the fifth agenda item was to improve hhs's collection of data to monitor how well research oversight is working under the common rule. 41 the sixth agenda item was to extend the reach of the common rule.4 2 institutions that receive any federal funding that makes them subject to the common rule would have to apply the common rule to all research (including privately funded research) at their sites. the final agenda item was to provide greater harmonization of guidance issued by the various federal agencies that administer versions of the common rule. 4 3 hhs extended the comment period once at the request of affected parties. 44 the period for comments closed on september 26, 2011. the anprm docket received about 1,100 comments, some of them extensive and detailed.45 one year later, as this article was written, hhs still had not taken the next step of publishing proposed regulatory text for public comment. such a delay is not unusual in a major rulemaking process and can suggest any number of things. for example, executive agencies may be reluctant to press forward with major, controversial rule changes during election years; the preliminary policies in an anprm 39 see discussion infra part ii. b. 40 hhs, anprm, supra note 15, at 44, 524 27. 41 id. at 44,527 28. 42 id. at 44,528. 43 id. 44 u.s. dep't of health & human servs., human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators; extension of comment period, 76 fed. reg. 54,408 (sept. 1, 2011). 45 see regulations.gov, www.regulations.gov (last visited mar. 18, 2013) (using the docket identifier "hhs-ophs-2011-0005"). vol. 10.2374 why the common rule is hard to amend sometimes lose momentum and need to be rethought before advancing to the next stage of rulemaking; or it simply can take more than a year for an agency, even when it is working diligently, to analyze a large volume of public comments and develop specific, proposed language to amend its regulations. b. existing and proposed consent provisions for data and biospecimens nonconsensual access to health information and biospecimens is lawful and regularly occurs under the existing common rule and the hipaa privacy rule. 4 6 before these regulations came into being, there were wellestablished legal traditions supporting unconsented access in various contexts such as public health practice.47 surveys show that the public feels concerned about any unconsented use of their health information, 48 but the current regulations allow such uses and they have been happening for many years. as a baseline rule, the common 46 see evans, supra note 5, at 82-86 (describing the existing framework for nonconsensual access to data under the hipaa privacy rule and common rule). 47 see paul j. amoroso & john p. middaugh, research vs. public health practice:' when does a study require irb review.', 36 preventive med. 250, 250 (2003) (providing as examples of public health activities mandatory reporting of communicable diseases, investigating disease outbreaks, and collecting confidential information by public health authorities to protect the public health); see also iawrence 0. gosnn, puglic health iaw 4 (2nd ed. 2008) (characterizing public health law as focusing on population-oriented (as opposed to patientspecific) efforts "to ensure the conditions for people to be healthy (to identify, prevent, and ameliorate risks to health in the population)" and "to pursue the highest possible level of physical and mental health in the population, consistent with the values of social justice"). 48 see, e.g., 1m, privacy report, supra note 9, at 66 (noting that, "[iln some surveys, the majority of respondents were not comfortable with their health information being provided for research except with notice and express consent"); see also 10m, privacy report, supra note 9, at 82 (reporting results of multiple surveys that found "[platients were much more comfortable with the use of anonymized data (e.g., where obvious identifiers have been removed) than fully identifiable data"). 2013 375 indiana health law review rule and the hipaa privacy rule call for a consensual scheme of access and require informed consent 49 and/or a privacy authorization50 before information can be disclosed to a data user. however, these regulations are rife with exemptions,5 1 exceptions, 52 and definitions53 that place specific activities-such as uses of data in judicial proceedings and public health activities-outside the usual consent and authorization requirements. 54 both of the existing regulations also allow nonconsensual access to data by researchers, subject to various conditions that aim to reduce privacy risks: for example, if the data are de-identified,55 coded,56 or reduced 49 45 c.f.r. § 46.116 (2010) (describing the common rule's basic informed consent requirements). 50 see 45 c.f.r. § 164.508 (2010) (describing the hipaa privacy rule's basic authorization requirements). 51 see id. § 46.101(b)-(d) (providing exemptions to the common rule). 52 see id. § 164.512 (providing exceptions to the hipaa privacy rule's authorization requirements). 53 see, e.g., id. § 46.102(d) and (f) (defining the terms "research" and "human subject"); see also u.s. dep't of health & human servs., ohrp guidance on research involving coded private information or biological specimens, hhs.gov (oct. 16, 2008), http://www.hhs.gov/ ohrp/policy/cdebiol.html (last visited mar. 21, 2013) [hereinafter ohrp guidance] (construing these definitions in a way that causes research with de-identified and coded data and biospecimens not to be regarded as human subject research and not too require informed consent under the common rule, provided certain conditions are met). 54 see barbara j. evans, congress' new infrastructural model of medical privacy, 84 notre dame l. rev. 585, 597, 619-22, 625-30 (2009) (describing in more detail the provisions for nonconsensual data access under the hipaa privacy rule and nonconsensual access to data under the common rule and under the food & drug administration's human-subject protection regulations at 21 c.f.r. pts. 50, 56); see also kristen rosati, an analysis of legal issues related to structuring fda sentinel initiative activities (2009), available at http://www.regulations.gov/#!documentdetail;d=fda-2009-n-01920003.2 (discussing provisions of the privacy rule, common rule, the privacy act, and other relevant laws that affect access to data in postmarketing drug safety surveillance activities). 55 see 45 c.f.r. § 164.514(b) (2010) (providing that data can be deidentified, under hipaa, by stripping off eighteen types of identifiers or by having a statistician certify that the risk of re-identification is "very small"); 45 c.fr §46.102(0 (defining "human subject" and implying that vol. 10.2376 why the common rule is hard to amend to a limited data set.5 7 the waiver provisions5 8 of the common rule and hipaa privacy rule are the major pathway for nonconsensual research use of identifiable data and biospecimens. these provisions empower institutional review boards or privacy boards (collectively, "irbs")69 to approve waivers of the usual consent and authorization requirements. under hipaa, data supplied under a waiver must meet "minimum necessary"60 requirements. in other words, data and biospecimens can be disclosed only to the extent necessary to support the intended research purpose. the regulations specify various criteria to be met before an irb can approve a waiver.61 these criteria do not require de-identification or even coding, and it is theoretically possible to acquire identifiable information without consent pursuant to an irb-approved waiver. 62 many irbs, in practice, resist such disclosures but the regulations technically would allow them. research uses of data are not human subject research if investigators receive no identifying information and have no interactions with the subjects). but see hhs, anprm, supra note 15, at 44,519, 44,523 (proposing to require consent for some uses of de-identified data that would not require it under the present common rule). 56 see 45 c.f.r. § 164.514(c) (2010) (providing that coded data can be treated as de-identified under the hipaa privacy rule if the code key complies with various restrictions on derivation and access); ohrp guidance, supra note 53 (discussing appropriate coding of data and biospecimens under the common rule). 57 45 c.f.r. § 164.514(e). 58 45 c.f.r. § 164.512(i) (2010) (hipaa waiver provision); 45 c.f.r. § 46.116(d) (common rule waiver provision). 69 see 45 c.f.r. §§ 46.103(b), 46.107-108 (2010) (desaribing irbs for purposes of the common rule); 45 c.f.r. § 164.512(i)(2)(iv) (providing that waivers of authorization under the hipaa privacy rule may be approved by either a common rule-compliant irb or by a hipaacompliant "privacy panel" that is structurally similar to an irb). 60 45 c.f.r. § 164.514(d) (2010). 61 id. § 164.512(i) (2010) (hipaa waiver provision); id. § 46.116(d) (common rule waiver provision). 62 see barbara j. evans, pharmacogenomics: applications to patient care 313, 331 (howard l. macleod et al. eds., 2nd ed. 2009). r1.2(a); r15 (this is one chapter that evans authored in a book, i treated under r15) ,2013 377 indiana health law review the anprm proposed changing the common rule's consent requirements for research that uses de-identified data and biospecimens. there have been ongoing concerns about the potential to re-identify such data and tissue resources, particularly with respect to genetic information. the risk of re-identification had become something of a hot topic in the year leading up to the anprm's publication,63 and the anprm lavished a great deal of attention on this risk. the anprm proposed to require written consent for research with pre-existing biospecimens (that is, specimens that have been collected prior to the time a research project commences), even when the specimens are de-identified in the sense of having had names and other overt identifiers removed. 64 in effect, anprm would treat biospecimens as intrinsically identifiable because of the genetic information imbedded in them. this new consent requirement would only apply prospectively to specimens collected after the amended common rule goes into effect. 65 for secondary research uses of existing health data, the proposed consent requirements would vary depending on the context in which the data originally were gathered. 63 see fed. trade comvi'n, protecting consumer privacy in an era of rapid change: a proposed framework for businesses and policymakers 35-38 (2010) (warning that the distinction between personally identifiable information and non-identifiable information is increasingly irrelevant in light of the potential for data to be reidentified); paul ohm, broken promises of privacy.' responding to the surprising failure of anonymization, 57 ucla l. rev. 1701, 1706 (2010) (discussing the risks to individual privacy if de-identified data were to be re-identified); mark a. rothstein, is deidentification sufficient to protect health privacy in research .9 10 am. j. bioethics 3, 5 (2010) ("despite using various measures to deidentify health records, it is possible to reidentify them in a surprisingly large number of cases . . . ."); but see deven mcgraw, data identifiability and privacy, 10 am. j. bioethics 30, 30 (2010) ("using information in less identifiable form greatly reduces risks to privacy. . . ."); daniel a. moros & rosamond rhodes, privacy overkill, 10 am. j. bioethics 12, 13 (2010) ("there is no evidence to suggest, and no obvious reason to suppose ... that the current protections of deidentified research information are inadequate."). 64 hhs, anprm, supra note 15, at 44,519, 44,527, tbl. 1. 65 id. at 44,520. vol. 10.2378 why the common rule is hard to amend secondary use of data collected for non-research purposes would not require consent so long as the data are deidentified.66 thus, data originally collected for treatment or administrative (for example, insurance) purposes could be used in de-identified form without consent, just as such data can be used under the present common rule. here, the anprm proposed no change from existing policy. however, data originally collected for one research purpose could not be de-identified and redeployed for secondary use in a different research project.67 a fresh consent would be required for the secondary research use. this proposal sought to curtail a questionable practice that sometimes occurs today, in which researchers obtain informed consent to collect data for a disclosed research purpose and then, by de-identifying the data, are able to use it in additional, undisclosed research projects. 68 obviously, if the secondary uses are already contemplated when investigators are procuring the original consent, it is fraudulent not to disclose those uses to the research subject. the anprm would prevent such fraud by requiring investigators to obtain consent for all research studies that are being contemplated, even if those studies would only use the data in de-identified form. unfortunately, this proposal also would require consent for future uses of de-identified data that were not contemplated at the time the original consent was procured. quite often, future uses of de-identified data are not anticipated at the time of the original consent. such uses may address scientific questions that arise long after the original research was completed. secondary uses are not a fraud on the original consent if the investigators were not contemplating them when they procured that consent. there is a meaningful legal distinction between premeditated and unanticipated secondary uses of research data. unfortunately, the anprm did not acknowledge this distinction and simply would ban all unconsented uses of de-identified data, even those involving no fraud. the 66 id. at 44,520. 6 7 id. 6 8 id. 2013 379 indiana health law review anprm was seeking to address a real problem-fraud on the informed consent process-but its proposed solution was overbroad. the anprm posed questions but did not offer any specific proposals on two matters that are central to the debate about nonconsensual access to data and biospecimens: 1. whether consent should be required for certain activities, such as quality improvement, public health, and program evaluation studies, that offer significant benefits to the general public,69 2. under what circumstances it is appropriate to waive the requirement of informed consent.70 the search for sound policy on these matters requires a more fundamental rethinking of the common rule than the recent anprm offered.71 part iii explores why finding sound policy on these matters is one of the defining challenges of 21st-century health law and bioethics. part iv then explores the challenge of fashioning an appropriate process for making any major changes to the consent provisions of the common rule. iii. the substantive challenge of modernizing informed consent requirements for data and biospecimens the anprm offered a fairly detailed proposal for modernizing the consent rules for research that uses deidentified data and tissue resources, but scarcely touched 69 id. at 44,521, question 24 (seeking public comment on whether certain high-valued uses of data, such as quality improvement and public health activities, should lie outside the common rule's consent requirements). 70 see id. at 44,523-25 (contemplating circumstances under which consent requirements could still be waived). 71 see, e.g., evans, supra note 5, at 69 (criticizing the reform agenda outlined in the anprm). 380 vol. 10.2 why the common rule is hard to amend the problem of access to identified data and biospecimens. de-identified data have only limited scientific utility,72 so the anprm evaded the pivotal issue in an age of large-scale informational studies. that pivotal issue is the framework for nonconsensual access to identifiable health information. under existing regulations, this framework includes the provisions of the common rule and the hipaa privacy rule that allow nonconsensual access to data and biospecimens for public health, quality improvement, and program evaluation activities and the provisions allowing waiver of consent for research. the epicenter of this problem is studies that require longitudinally linked health records. such records allow patients' treatments and outcomes to be monitored on an ongoing basis across multiple encounters with the healthcare system.73 creating longitudinal health records 72 id. at 92-94 (discussing the scientific utility of various categories of health information and explaining why de-identified data are not a high-quality data resource for many types of scientific study); see also u.s. dep't of health & human servs., food and drug admin, report to congress: the sentinel initiative--a national strategy for monitoring medical product safety 11 (2011), available at http://www.fda.gov/downloads/safety/fdassentinellnitiative/ucm2745 48.pdf ("as we have begun to grapple with the realities of conducting active medical product surveillance, however, we have come to understand that there may be infrequent occurrences when deidentified datasets may be insufficient to meet the needs of medical product surveillance."); see also letter from stanley h. weiss, chair, joint policy committee of the societies of epidemiology, to jerry menikoff, director, office for human subject protections (oct. 26, 2011), available at www.regulations.gov (last visited mar. 23, 2013) (referencing document id: hhs-ophs-2011-0005-1066, at 4-5) (noting that in "[r]esearch on adverse drug events using computer-stored prescription data linked with hospital data . .. it is necessary to have information on identifiers in order to link the data that permits the research to be done"). 73 see u.s. food & drug admin., sentinel network public meeting 51-56 (mar. 7, 2007) (statement of dr. marc overhage) [hereinafter fda, march 7 proceedings], available at http://www.fda.gov/ohrms/ dockets/dockets/07n0016/07n-0016-tro001.pdf (discussing importance of linking data longitudinally for use in observational studies of drug safety and noting that achieving longitudinal linkage requires at least some sharing of identifiable information); us food & drug admin., sentinel network public meeting 73-74 (mar. 8, 2007) (statement of dr. 2013 381 indiana health law review requires at least some use of identifiable information to ensure that data received from various locations all pertain to the same person. 74 because of this fact, access to deidentified data and biospecimens-even if the common rule continues in the future to allow it-will not answer the needs of studies that require longitudinal linkage of data from multiple insurers, healthcare providers, and biospecimen repositories. moreover, consent bias is a genuine phenomenon in some research contexts: the subset of people who are willing to consent to research may not be reflective of the general population being studied.75 this fact implies a need for a suitably constrained mechanism allowing nonconsensual access in situations where the resulting bias would pose a problem. conditioning access on patient consent can undermine the validity of some (although not all) types of scientific study.76 an important but poorly understood point is that shifting from an opt-in77 to an opt-out 7 8 consent clement mcdonald) [hereinafter fda, march 8 proceedings], available at http://www.fda.gov/ohrms/dockets/dockets/07n0016/07n-0016-tro002. pdf (discussing the importance of longitudinal population health data in drug safety research and noting the need to share identifiable information to link records from various data sources). 74 see 45 c.f.r. § 46.101(b) (2010); hhs, anprm, supra note 15, at 44,518, col. 2 44,521, col. 3. 75 see generally brian buckley et al., selection bias resulting from the requirement for prior consent in observational research a community cohort of people with ischaemic heart disease, 93 heart 1116 (2007); casarett et al., supra note 8, at 593-94; iom, privacy report, supra note 9, at 209-14 (surveying studies of consent and selection bias); khaled el emam et al., a globally optimal k-anonymity method for the de-identification of health data, 16 j. am. med. info. ass'n 670, 670 (2009); steven j. jacobsen et al., potential effect of authorization bias on medical record research, 74 mayo clinic proc. 330 (1999); jack v. tu et al., impracticability of informed consent in the registry of the canadian stroke network, 350 new eng. j. med. 1414 (2004); steven h. woolf et al., selection bias from requiring patients to give consent to examine data for health services research, 9 archives fam. med. 1111 (2000). 76 evans, supra note 5, at 92, 95-96. 77 see mark a. rothstein, health privacy in the electronic age, 28 j. legal med. 487, 490-91 (2007) (defining an opt-in consent framework as one that allows data to be used only if the patient affirmatively consents); see also 45 c.f.r. § 46.116 (2010) (adopting an vol. 10. 2382 why the common rule is hard to amend framework cannot fully eliminate consent bias.79 these facts imply a need for an appropriate framework for approving and managing nonconsensual uses of identifiable data and biospecimens. the devil is in the details of defining procedures and protections that are "appropriate" when taking people's data and biospecimens without their consent. the existing common rule and hipaa privacy rule already contain such a framework, so the notion of allowing nonconsensual access is not a radical departure from existing policies. however, it is probably fair to say that all sides are unhappy with the existing framework, which is criticized both for being too permissive and too parsimonious in granting access to data and biospecimens. recent technological developments and legislation place further pressure on the existing regulatory framework. it is important to understand the sheer scale of data systems that are feasible from a technical point of view and which are necessary to achieve some of the objectives congress has set in recent legislation. a good example is the food and drug administration amendments act of 2007 (fdaaa),80 which calls for heavy use of observational (epidemiological) studies as a source of regulatory and scientific evidence for postmarketing drug safety regulation. in fdaaa, congress authorized development of a 100-million-person postmarketing drug safety surveillance system.8' as of july, 2011, the food and drug administration's (fda's) opt-in consent scheme in the presently effective common rule); 45 c.f.r. § 164.508 (adopting opt-in consent in the hipaa authorization requirements). 78 see, e.g., michael birnhack & niva elkin-koren, does law matter online? empirical evidence on privacy law compliance, 17 mich. telecomm. & tech. l. rev. 337, 339 (2011), available at http://papers.ssrn.com/sol3/papers.cfm?abstractid=1456968 (describing an opt-out consent scheme that presumes data can be used unless the data subject affirmatively objects). 79 evans, supra note 5, at 96. 80 pub. l. no. 110-85, 121 stat. 823 (2007) (codified as amended in scattered sections of 21 u.s.c.). 81 see fdaaa, supra note 2, at § 905 (introducing a new § 505(k)(3) to the ffdca) (codified at 21 u.s.c. § 355(k)(3)). 2013 383 indiana health law review mini-sentinel project, 82 which is the pilot phase of this system, 83 already held information for ninety-nine million health plan members, including sixty-three million people between the ages of twenty and sixty-four, and 8.1 million pediatric patients aged nine or under.84 there were 300 million person-years of data from 2.4 billion unique patient encounters with healthcare providers, including thirty-eight million acute inpatient stays and 2.9 billion dispensings of prescriptions, and all the data were being regularly updated.85 similarly scaled drug safety networks are under development in canada,86 the european union,87 and japan.88 82 see richard platt et al., the us. food and drug administration's mini-sentinel program: status and direction, 21 pharmacoepidemiology and drug safety 1 (2012) (describing the mini-sentinel pilot project); see also lesley curtis et al., design considerations, architecture, and use of the mini-sentinel distributed data system, 21 pharmacoepidemiology & drug safety 23, 28 (2012) (discussing the types of data included in the system); melissa robb et al., the us. food and drug administration's sentinel initiative: expanding the horizons of medical product safety, 21 pharmacoepidemiology & drug safety 9, 9-10 (discussing various applications of the system). 83 rachel e. behrman et al., developing the sentinel system a national resource for evidence development, 364 new eng. j. med. 498, 498 (2011); see also u.s. food & drug admin., the sentinel initiative (2008), available at http://www.fda.gov/downloads/safety/ fdassentinellnitiative/ucm124701.pdf (discussing the goals and structure of the sentinel data network); see also fda's sentinel initiative, u.s. food & drug admin., http://www.fda.gov/safety/ fdassentinellnitiative/default.htm (last visited mar. 22, 2013) (discussing recent progress toward implementation of the sentinel system). 84 curtis et al., supra note 82, at 28. 85 platt et al., supra note 82, at 4. 86 see in brief the drug safety and effectiveness network (dsen), can. insts. of health res., http://www.cihrirsc.gc.ca/e/39389.html (last visited mar. 9, 2013) 0; medicines that work for canadians: business plan for a drug effectiveness and safety network, health canada (2007), http://www.hc-sc.gc.ca/hcs-sss/alt_ formats/hpb-dgps/pdf/pubs/pharma/2007-med-workeff/2007-med-workeff-eng-final.pdf (last visited mar. 9, 2013) (describing canada's dsen network). 87 see press release, european medicines agency, emeacoordinated protect project has been accepted for funding by the vol. 10.2384 why the common rule 18 hard to amend multi-million person health data networks are a necessary resource, if the goal is to detect emerging drug safety problems significantly faster than the 65 months that it took for the fda to confirm that rofecoxib (vioxx) was causing cardiovascular problems and needed to be removed from the market. 89 six months before congress passed fdaaa, the fda heard testimony 90 that the time it took to confirm the safety problem with vioxx could have been cut almost in half-to 34 months-had the agency been conducting pharmacoepidemiological surveillance studies using insurance claims data for seven million persons. with data for 100 million people, the problem could have been confirmed within 3 months. 91 innovative medicines initiative joint undertaking (apr. 30, 2009), http://www.ema.europa.eu/ema/index.jsp?curl=pages/newsandevents/ news/2009/11/news detail 000096.jsp&jsenabled=true (last visited mar. 9, 2013) (describing the protect network); implementation of the action plan to further progress the european risk management strategy rolling two-year work programme (2008-2009), european medicines agency (dec. 24, 2007), http://www.emea.europa.eu/pdfs/ human/phv/28008907en.pdf (last visited mar. 9, 2013) (describing the encepp data network); european network of centres for pharmacoepidemiology and pharmacovigilance ("encepp"), http://encepp.eu (last visited mar. 9, 2013); eu-adr, http://www.alertproject.org/ (last visited mar. 9, 2013) (describing the european union adverse drug reactions data network). 88 kaoru misawa, dir., office of safety, pharm. & med. devices agency, address at the 9th kitasato university-harvard school of public health symposium: sentinel initiative in japan: utilization of electronic health information in pharmacovigilance 7-14 (sept. 11-12, 2009), http://www.pharm.kitasato-u.ac.jp/biostatis/khsympo2009o9/doc/ misawa.pdf (last visited mar. 16, 2013). 89 evans, supra note 2, at 456. 90 u.s. food & drug admin., u.s. dep't of health & human servs., proceedings, sentinel network public meeting 67-68 (2007) (statement of dr. richard platt) [hereinafter fda, march7proceedings], avalable at http://www.fda.gov/downloads/safety/fdassentinellnitiative/ ucm116513.pdf. 91 id. at 70. note that this three-month figure was counted from the time data became available for analysis. in practice, it takes several months for insurance claims data to stabilize after patients receive healthcare, so in practice it might take six or seven months rather than the three months reported. 2013 385 indiana health law review such findings underscore a feature of the 21st century research environment: some of the emerging-and very promising-types of informational study are inherently collective in their nature.92 unlike the randomized, controlled clinical trials for which the common rule was primarily designed, these new methodologies sometimes require extremely large, inclusive datasets free of the biases that can creep in if people self-select for research participation. restricting the use of data to protect privacy could actually leave people to die. this does not necessarily mean there is a "research imperative" 93 that compels us to allow such studies merely because they could save other people from death or serious injury. it merely means that if we want to save those lives, some nonconsensual access to identifiable data will be required. perhaps we as a society do not want to save those lives. perhaps we are at a moment in history where there are so many excess people in the world, and so many embarrassing medical facts in storage, and so much risk of malicious or inadvertent disclosure of those facts that, in the greater balance of things, protecting people's medical secrets has become a higher priority than saving a few thousand human lives. it is true that soldiers nobly sacrifice their lives for abstract ideas like "freedom" and "liberty," and americans have some degree of comfort with those sacrifices. are they equally comfortable with the notion that abstract ideas of ''patient autonomy" and "data privacy" and "patient control over medical data" are worth a few thousand or tens of thousands of preventable deaths (so long as it is someone else)? that may be a legitimate question to ask; it is possible, after all, to entertain an idea without accepting 92 see evans, supra note 5, at 76 (discussing why large-scale informational research is an inherently collective enterprise). 93 see daniel callahan, what price better health? (2006) (challenging the notion that medical research is inherently good and should be pursued without regard to the burdens it places on competing values); but see mildred z. solomon & ann c. bonham, ethical oversight of learning health care systems: ethical oversight of research on patient care, 43 hastings center rep. s2 (2013) (suggesting that patients may have a "moral imperative" to participate in a learning healthcare system). 386 vol. 10.2 why the common rule is hard to amend it.94 by way of disclosing personal biases, however, i too can entertain the idea that privacy may be worth the cost of human life, but i personally do not accept that idea. likei suspect-many americans, i want a great deal of personal control over what is done with my data and biospecimens, but in the final analysis i am not prepared to insist that my medical secrets be protected at the cost of other people's lives. others are free to value things differently, and their valuations deserve respect. what many americans want, perhaps, is not so much the right to consent to each and every use of our data and biospecimens, but a strong assurance that every unconsented use of these resources will, in fact, serve a vital, life-saving objective. the waiver provisions of hipaa and the common rule presently lack a meaningful "public use" criterion to assure us that unconsented uses of our data and biospecimens will serve a socially beneficial purpose. 95 on those terms, unconsented use of our data and biospecimens is indeed objectionable. obtaining consent from 100 million people raises obvious questions of practicability and, indeed, the large pharmacoepidemiological networks described earlier do not rely on consent as the mechanism for privacy protection. nonconsensual access to data for use in the fda's postmarketing drug safety surveillance is possible because this a public health use,96 which can occur nonconsensually 94 see "it is the mark of an educated mind to be able to entertain a thought without accepting it" attributed to aristotle, quotes.net, http://www.quotes.nte/quote/1979 (last visited mar. 9, 2013). 95 see evans, supra note 5, at 119 24 (discussing the lack of criteria in the hipaa and common rule waiver provisions to ensure that unconsented disclosures of data and biospecimens will serve socially beneficial objectives). 96 see letter from rachel behrman, sentinel initiative executive sponsor, to dr. richard platt, harvard medical school and harvard pilgrim health care (july 19, 2010), in kristen rosati , barbara evans & deven mcgraw, hipaa and common rule compliance in the mini-sentinel pilot 12-14 (2010), available at http://minisentinel.org/work-products/aboutus/hipaaandcommonrulecompli ance in themini-sentinelpilot.pdf (emphasizing that all presently planned uses of the mini-sentinel system constitute public health activities by the fda). 3872013 indiana health law review under the common rule and hipaa privacy rule. 9 7 whether a consent requirement actually protects privacy has been the subject of considerable debate,98 and there have been many calls for alternative protections, for example, strict data security arrangements and fair information practices. 99 the fda adopted this latter approach for its mini-sentinel system. it employs a distributed networked architecture that leaves identifiable data sequestered behind the privacy firewalls of the healthcare providers and insurers who already hold the data,100 and it implements a special framework of privacy and operating policies that congress required the fda to develop, and which are now in place. 101 achieving access for public health applications is, however, just one small part of the problem. many socially beneficial data uses will be privately sponsored, particularly in an era of intense pressure on government budgets. there has been a tendency, in recent legislation, to blur traditional lines between "private" and "public" and between "research" and "public health." once again, fdaaa supplies an example. it added a new § 505(o)(3)102 to the federal food, drug, and cosmetic act ("ffdca"),103 which allows the fda to order pharmaceutical companies to 97 see, e.g., letter from jerry menikoff, director, office for human research protections, to rachel e. behrman, acting assoc. dir. of med. policy, center for drug evaluation and research, u.s. food & drug admin. (jan 19, 2010), in rosati et al., supra note 96, at 10 (deeming sentinel activities not to be regulated by the common rule). 98 see, e.g., fred h. cate, protecting privacy in health research: the limits of individual choice, 98 calif. l. rev. 1765, 1797 (2010) ("consent requirements not only impede health research, but may actually undermine privacy interests."). 99 iom, privacy report, supra note 9, at 4-5. 100 see curtis, supra note 82 (discussing mini-sentinel's distributed architecture). 101 see mini-sentinel:. principles and policies, mini-sentinel.org (august 2012), http://mini-sentinel.org/work-products/aboutus/minisentinel-principles-and-policies-august2012.pdf#page=27 (last visited mar. 16, 2013). 102 21 u.s.c. § 355(o)(3) (2012). 103 federal food, drug, and cosmetic act of 1938, pub. l. no. 75717, 52 stat. 1040 (1938) (codified as amended at 21 u.s.c. §§ 301-399 (2006)). 388 vol. 10.2 why the common rule is hard to amend conduct postmarketing observational studies of drug safety.104 in some respects these § 505(o)(3) observational studies do resemble a public health activity: the fda, acting in its capacity as a public health agency, can order the studies only in response to a narrow set of statutorily defined public health concerns about the safety of approved drugs.105 yet these studies also have attributes of commercial research, because they are likely to produce generalizable knowledge about drug safety and will be conducted or at least sponsored by private-sector pharmaceutical companies. 106 unfortunately, it appears unlikely that any data actually will be available to use in these studies. irbs, in their role of approving hipaa waivers for access to data held by insurers and healthcare providers, are likely to balk at characterizing these studies as a public health activity for which nonconsensual access to data would be allowed.107 these irbs also may be reluctant to approve hipaa waivers allowing the release of data to commercial pharmaceutical companies that, ordinarily, are not subject to the hipaa rule and the common rule.108 fda's own human subject protections apply to clinical studies and do not even appear to cover observational studies that use data.109 this resulting lack of data access could have several bad consequences. these include requiring the fda 104 see u.s. dep't of health & human servs., u.s. food and drug admin., ctr. for drug eval., and res. & ctr. for biologics eval. and res., guidance for industry: postmarketing studies and clinical trials -implementation of section 505(o)(3) of the federal food, drug, and cosmetic act (2011) [hereinafter, "fda, april 2011 guidance"], available at http://www.fda.gov/downloads/ drugs/guidancecomplianceregulatorylnformation/guidances/ucm172 001.pdf (describing how the fda plans to use its powers to order postmarketing studies and clinical trials). 105 id. at 4 (referencing § 355(o)(3)(b)). 106 barbara j. evans, the ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the food, drug, and cosmetic act, 38 am. j.l. & med. 577, 585 (2012). 107 see id. at 587-94 (discussing barriers to access to data for sec. 505(o)(3) studies). 108 id. at 592-93. 109 id. at 593. 3892013 indiana health law review (in other words, taxpayers) to fund drug safety studies that could have been financed by pharmaceutical companies if data had been available; subjecting human subjects to the very real risks of postmarketing safety-related clinical trials to answer questions that might have been answered less intrusively via observational studies; and leaving injuryproducing drugs on the market because of delays in generating sound evidence with which the fda could act to manage their risks. 110 the incapacity of old, 20th-century regulations, such as the common rule, to accommodate these novel "hybrid" (public/private) data uses is another major factor fueling pressure for reform. deciding what to do is a normative bioethical problem: what should policy be? the normative problem is indeed an important problem but it is not the only problem. iv. finding an appropriate process to modernize the common rule the anprm111 presumed that it is lawful to amend the informed consent provisions of the common rule by means of informal, or notice-and-comment, rulemaking. informal rulemaking under the administrative procedure act ("apa")112 is the familiar process through which a federal agency develops a proposed regulation, publishes notice of the proposed rulemaking in the federal register, and allows a period for the public to submit written comments, after which the agency may withdraw its proposal, revise it, or promulgate a final regulation accompanied by a statement explaining the agency's action. 113 the process is "informal" in that the agency may, 114 but is not required to, hold a formal evidentiary hearing at which interested 110 id. at 595-598. 111 see hhs, anprm, supra note 15. 112 the administrative procedure act of 1946, ch. 324, 60 stat. 237 (1946) (codified as amended at scattered sections of 5 u.s.c.); see 5 u.s.c. § 553 (2012). 113 5 u.s.c. § 553 (2012). 114 5 u.s.c. § 553(c); vermont yankee nuclear power corp. v. nrdc, 435 u.s. 519, 524 (1978) (dictum). 390 vol. 10.2 why the common rule is hard to amend parties can appear and challenge the evidence on which the agency will base its decision. informal rulemaking has been an important way for agencies to promulgate and amend regulations in the seventy or so years since the apa was enacted.115 it is not sufficient, however, when congress has enacted a statute that requires an agency to employ some other procedure when making or amending its rules. this section explores special procedures that congress imposed by statute at the inception of efforts to develop the common rule. the relevant statutes are still in effect today and they constrain hhs's power to amend the common rule's informed consent requirements for data and biospecimens. for major, substantive amendments of the type contemplated in the anprm, ordinary informal rulemaking procedures may not be lawful. this raises the possibility that the agency may need to follow different procedures or even seek additional authority from congress to make some of the changes it proposed in the anrpm. a. sources of hhs's authority to amend the common rule any amendments to the common rule must be consistent with the statutes that authorize hhs to regulate in the area of human subject protections. the common rule cites its three sources of statutory authority as 5 u.s.c. § 301; 42 u.s.c. § 289 and in particular, § 289(a); and 42 u.s.c. § 300v-1(b).116 these statutes empowered hhs and its precursor, the department of health, education, and welfare (hew) to promulgate the common rule in its present form. in the absence of subsequent statutes altering hhs's authority to regulate in this area, these same three statutes define the scope of hhs's power to amend the common rule. 115 see, e.g., james v. delong, informal rulemaking and the integration of law and policy, 65 va. l. rev. 257, 257 260 (1979) (commenting on the widespread use of informal rulemaking). 116 see 45 c.f.r. pt. 46, subpt. a (citing, at the end of each section of the common rule, the statutes that authorized promulgation of the respective sections of the regulation). 3912013 indiana health law review the statute at 5 u.s.c. § 301 is a generally applicable "housekeeping" statute that authorizes the head of any federal agency to set regulations to govern the agency's own operations. this statute undergirds those parts of the common rule that define roles that hhs, ohrp, and their personnel are to play in administering the overall framework of research oversight. the authority conferred by this statute supports some of the anprm's proposed initiatives, such as the proposal to improve hhs's collection of data to monitor how well the common rule is working.117 this statute provides no authority, however, to set substantive standards of human subject protection, such as informed consent requirements and other standards that define the rights and duties of human research subjects, investigators, and research institutions. 118 the statute at 42 u.s.c. § 289(a)119 is part of the public health service act's subchapter governing the national institutes of health. it grants the secretary of hhs ongoing power to prescribe regulations governing the establishment of institutional review boards (irbs) that review research funded by the nih. 120 under this statute, hhs can require grant applicants to have an irb and can set rules (such as irb membership and registration requirements) that govern how to establish an irb. this statute supports some of the anprm's initiatives, such as the proposal to recognize a single irb of record for multisite studies. 121 as worded, 122 however, 42 u.s.c. § 289(a) does 117 hhs, anprm, supra note 15, at 44,527-28. 118 see 5 u.s.c. § 301 (2012). 119 see 42 u.s.c. § 289(a) (2012) ("the secretary [of hhs] shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the secretary that it has established (in accordance with regulations which the secretary shall prescribe) a board (to be known as an "institutional review board") to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research."). 120 id 121 hhs, anprm, supra note 15, at 44,521-22. 392 vol. 10. 2 why the common rule is hard to amend not grant hhs any power to set the substantive standards of human subject protection that guide irbs, once they are established, in their oversight of research. a separate statute, 42 u.s.c. § 300v-1, defines the process for developing the common rule's substantive standards including "the requirements for informed consent to participation in research projects."123 part of this statute, § 300v-1(b), authorizes the secretary of hhs to regulate in this area, and the common rule relies on § 300v-1(b) as its third source of statutory authority. congress imposed special procedural requirements that hhs must follow when establishing informed consent requirements. this statute is thus quite different from the two just discussed, 5 u.s.c. § 301 and 42 u.s.c. § 289(a), which impose no special procedural requirements. hhs is free to employ default a.p.a. procedures, including informal rulemaking, when making or amending regulations under those two statutes. unfortunately, u.s.c. § 301 and 42 u.s.c. § 289(a) do not authorize hhs to amend the common rule's informed consent requirements. legal authority for hhs to amend the informed consent requirements, if it exists at all, arises under 42 u.s.c. § 300v-1 and requires special procedures in addition to the usual apa informal rulemaking requirements. 122 see 42 u.s.c. § 289(a) (providing that grant applicants must show that they have "established (in accordance with regulations which the secretary shall prescribe) a board (to be known as an 'institutional review board') . . ."). the placement of the parenthetical phrase, "(in accordance with regulations which the secretary shall prescribe)" clearly relates it to the establishment of irbs, rather than to the substantive standards that they apply in reviewing research. this interpretation is consistent with the fact that congress saw a need to enact a separate statute, 42 u.s.c. § 300v-1, which does supply authority to establish substantive standards of human subject protection. 123 42 u.s.c. § 300v-1(a)(1)(a) (2012). 3932013 indiana health law review b. why congress constrained hhs's authority to set informed consent requirements the statute at 42 u.s.c. § 300v-1 was enacted as part of the national research act of 1978 ("1978 act").124 § 300v-1 replaced an earlier-and in many respects similar-statute enacted in the national research service award act of 1974 ("1974 act"). 125 a consistent theme in both statutes was that congress was hesitant to grant the secretary of hew/hhs unfettered discretion to set informed consent requirements and other substantive standards of human subject protection. congress imposed special procedures that constrain the secretary's authority to make and amend provisions of the common rule that establish substantive standards. several factors may explain these constraints. 1. inteligible principles to guide agency rulemaking. congress may have been concerned about using bioethical principles as a standard to guide delegated lawmaking authority because of their unintelligibility. on various occasions, the u.s. supreme court has expressed concern that delegation of lawmaking authority to an administrative agency is unconstitutional unless congress provides an intelligible principle to guide the agency. 126 in practice, the court has been very permissive in what it considers intelligible, 127 but bioethical principles press the outer limits of intelligibility. in a different legal contextqualification of expert witnesses-" [c]ommentators have 124 community mental health centers extension act of 1978, pub. l. no. 95-622, 92 stat 3412 (1978); see id. § 301 (establishing the president's commission for the study of ethical problems in medicine and biomedical and behavioral research). 125 national research act of 1974, pub. l. no. 93-348, §§ 201-02, 88 stat. 342 (codified as amended in scattered sections of 42 u.s.c.). 126 see, e.g., whitman v. american trucking ass'ns, 531 u.s. 457, 472 (2001) (citing j.w. hampton, jr., & co. v. united states, 276 u.s. 394, 409 (1928)). 127 see jeffrey a. wertkin, reintroducing compromise to the nondelegation doctrine, 90 geo. l. j. 1055 (2002) (noting a "disconnect between legal principle and application"). 394 vol. 10.2 why the common rule is hard to amend been highly skeptical about the reliability of bioethics testimony" 128 out of concern that ethics experts "disagree so much and so radically that we hesitate to say that they are experts."1'2 certain types of ethical testimony do satisfy the standards of admissibility. this is true of descriptive ethics (for example, describing the ethical beliefs or ethical practices of a group of people) and metaethical analysis (for example, identifying the ethical dimensions of an issue).130 normative ethics-testimony about "[w]hat ought to be the practice?" 131 is so slippery and debatable that there is ongoing controversy about whether it is worthy of being treated as a source of legal evidence.132 a grant of rulemaking authority to define what the practice of informed consent should be is, in essence, a license to give normative bioethical principles the force of law. ethicists disagree "so much and so radically"133 that this would amount to delegation without standards if the task were left to the discretion of an individual, such as the secretary of hhs. one secretary might view patient control of data as paramount while another might emphasize public benefits that might flow from wider access to data. congress refused to make such a delegation and instead empowered two statutorily created commissions to enunciate standards to guide future rulemaking. title ii of the 1974 act authorized creation of a national commission for the study of ethical problems in medicine and biomedicine (the "national commission").134 congress 128 bethany spielman & george agich, the future of bioethics testimony: guidelines for determining qualifications, reliability, and helpfulness, 36 san diego l. rev. 1043, 1055 (1999). 129 id. (citing j.r. bambrough, plato's political analogies, in plato, popper and politics 152, 158 (r. bambrough ed., 1967). 130 edward j. imwinkelried, expert testimony by ethicists, 76 temp. l. rev. 91, 96-98, 99 (2003). 131 id. at 98. 132 id. at 105-106. 133 spielman, supra note 128, at 1055 (citing bambrough). 134 see national research act of 1974, pub. l. no. 93-348, §§ 20102, 88 stat 342 (1974) (enacting 42 u.s.c. § 2891-1, the precursor of today's § 300v-1, creating the national commission and describing its role in developing substantive standards of human subject protection); see also hew, 1978 report, supra note 6 (discussing the national 3952013 indiana health law review ordered the national commission to "conduct a comprehensive investigation and study to identify the basic ethical principles, which should underlie the conduct of biomedical and behavioral research involving human subjects." 135 this mandate authorized work on the belmont report,136 which is still widely recognized and cited by bioethicists. many bioethicists today are less aware that congress prescribed additional duties for the national commission. the resulting work product has an enduring legal significance. congress called for the national commission to be directly involved in efforts to specify the substantive content of regulations at 45 c.f.r. pt. 46, which translate the belmont report's broad ethical principles into legally enforceable requirements. congress ordered the national commission to "develop guidelines which should be followed in such research"137 and to "make recommendations to the secretary . . . for such administrative action as may be appropriate to apply such guidelines to biomedical and behavioral research conducted under programs administered by the secretary."138 in a detailed 1978 report,13 9 the national commission issued its recommendations on the informed consent provisions and other substantive protections that should be included in the common rule. these recommendations (hereafter, "the regulatory recommendations"), along with the belmont report, set the parameters of human subject protection under the common rule. congress itself provided close oversight of the common rule as it developed. the 1974 act required the national commission to make periodic reports and recommendations to congress.140 congress held multiple hearings throughout commission's work and reporting its findings). 135 national research act §202(a)(1)(a)(i). 136 see protection of human subjects; belmont report: ethical principles and guidelines for the protection of human subjects of research, 44 fed. reg. 23,192 (1979) [hereinafter belmont report]. 137 national research act § 202(a)(1)(a)(ii). 138 national research act § 202(a)(1)(a)(iii). 139 see hew, 1978 report, supra note 6. 140 national research act of 1974, pub. l. no. 93-348, §§ 202(c)(3), 396 vol. 10.2 why the common rule is hard to amend the 1970s to explore issues related to human subject protection. although satisfied with the national commission's work, congress concluded that its mandate to focus on hhs-funded research programs was too narrow and should be broadened to address human subject protection problems at other federal agencies.141 the 1978 act replaced the national commission with a new president's commission 42 to address human subject protections for all federal agencies. this began the effort to arrive at a truly "common" rule.143 202(d), 204(d), 88 stat 342 (1974). 141 see s. rep. no. 95-852 (1978) ("although the committee believes that the national commission for the protection of human subjects of biomedical and behavioral research [the 1974 commission] has been functioning very successfully, as oversight hearings in this area have continued, it has become increasingly clear to the committee that the jurisdiction of the national commission is too limited. . . . "). 142 community mental health centers extension act of 1978, pub. l. no. 95-622, § 301, 92 stat 3412, (enacting 42 u.s.c. §§ 300v, 300v-1 to establish a president's commission for the study of ethical problems in medicine and biomedical and behavioral research). 143 a total of 18 federal agencies now follow the common rule, which has been codified in the federal regulations at 15 locations that regulate 16 federal agencies. in addition, the central intelligence agency follows the common rule, exec. order no. 12,333, 46 fed. reg. 59,941, 59,952 (dec. 4, 1981), and the social security administration follows the common rule, social security independence and program improvements act of 1994, pub. l. no. 103-296, §106(b), 108 stat. 1464, 1476 (1994). the 15 regulations are: 45 c.f.r. pt. 46 (hhs); 7 c.f.r. pt. 1 (2005) (department of agriculture); 10 c.f.r. pt. 745 (2005) (department of energy); 14 c.f.r. pt. 1230 (2005) (national aeronautics and space administration); 15 c.f.r. pt. 27 (2005) (department of commerce); 16 c.f.r. pt. 1028 (2005) (consumer product safety commission); 22 c.f.r. pt. 225 (2005) (international development cooperation agency; agency for international development); 24 c.f.r. pt. 60 (2005) (department of housing and urban development); 28 c.f.r. pt. 46 (2005) (department of justice); 32 c.f.r. pt. 219 (2005) (department of defense); 34 c.f.r. pt. 97 (2005) (department of education); 38 c.f.r. pt. 16 (2005) (department of veterans affairs); 40 c.f.r. pt. 26 (2005) (environmental protection agency); 45 c.f.r. pt. 690 (2005) (national science foundation); 49 c.f.r. pt. 40 (2004) (department of transportation). the office of science technology policy, because it does not conduct or sponsor research, has not codified the common rule even though it signed the federal policy that supplied the text of the common rule. the u.s. 3972013 indiana health law review congress already had received the national commission's regulatory recommendations1 44 when it enacted the 1978 act. congress stressed the need for continuity: the [senate] committee [on human resources] intends that the president's commission complete any of the duties of the existing national commission for the protection of human subjects of biomedical and behavioral research, as set forth in section 202 of public law 93-348 [the 1974 act] . . . . it is not the committee's intent, however, for the president's commission to repeat completed studies.145 the president's commission heeded congress' call to avoid duplicative effort 46 and endorsed the national commission's 1978 regulatory recommendations.147 as a result, those recommendations have ongoing vitality today. when congress delegated rulemaking authority to the secretary of hhs, this delegation was subject to a requirement that the secretary must conform future informed-consent-related proposals to the commission's recommendations.148 doing so sidestepped a potential constitutional problem. the power to give normative bioethical principles the force of law could be seen as a delegation lacking an intelligible principle. the 1978 regulatory recommendations supplied the necessary set of principles. food and drug administration does not implement the common rule, instead implementing its own framework of human-subject protections (21 c.f.r. pts. 50, 56 (2001)) which, while similar to the common rule, differ in important respects that bear on the regulation of research with biospecimens and data. 144 see hew, 1978 report, supra note 6. 145 see s. rep. no. 95-852, supra note 141, at 17. 146 42 u.s.c. § 300v-1(a)(2)(3) (2012). 147 id. 148 42 u.s.c. § 300v-1(b)(2) (2012). 398 vol. 10.2 why the common rule is hard to amend 2. procedural formality to ensure an inclusive dialogue. setting substantive standards for human subject protection implicates important interests of many stakeholders. the 1974 and 1978 acts reflect a congressional determination that ordinary, informal rulemaking does not provide an adequate opportunity for stakeholders to appear and challenge one another's views. informal rulemaking also may fail to mobilize the diverse forms of expertise that need to be brought to bear on such decisions. to ensure that the national commission would reach reasoned decisions based on high-quality evidence from a wide variety of experts and stakeholders, the 1974 act authorized the commission to pay its members and cover their travel expenses, hire staff, and procure the services of consultants and other contractors.149 regulatory scholars consider adequate professional staffing and funding essential to the "attributes of organizational autonomy" that enable regulatory decision-makers "to foster the requisite expertise" to make valid, legitimate decisions. 50 congress also gave the commission authority to collect data and evidence from any federal agency.151 the 1978 act ventured farther and authorized the president's commission to conduct hearings, take testimony, and receive such evidence as it deemed advisable.152 in other words, congress prescribed a process that took on features of apa formal rulemaking procedures. throughout the 1970s, informal rulemaking by the newly created single-value agencies had been the subject of numerous court challenges. in a series of cases during that decade, federal courts had transformed informal rulemaking by imposing special procedural requirements in excess of ordinary apa informal rulemaking procedures.153 this 149 national research act of 1974, pub. l. no. 93-348, § 201, 88 stat. 342 (1974). 150 warrick smith, note no. 127; utility regulators-the independence debate, pub. pol'y for priv. sector, oct. 1997, at 1, available at http://www.ictregulationtoolkit.org/en/document.1454.pdf. 151 national research act § 204(b). 152 42 u.s.c. § 300v-2 (2012). 153 see richard stewart, vermont yankee and the evolution of 3992013 indiana health law review trend had gradually converted informal rulemaking "into a new kind of on-the-record proceeding" 154-that is, into a proceeding that bore increasing similarity to a.p.a.'s formal rulemaking procedures that include evidentiary hearings and create a formal record to guide the regulator's decision. in the vermont yankee case,15 5 decided in april 1978, the supreme court ended this trend and sharply limited the role federal courts could play in overseeing agency rulemaking activities. the impact of this decision likely was on congress's mind as it finalized the 1978 act in november of 1978. congress may have felt it needed to impose special statutory procedural requirements for rulemakings related to the common rule's substantive provisions. after vermont yankee, it was clear that the federal courts would no longer be able to provide vigorous judicial oversight of agencies' informal rulemaking activities. 3. substantive policy concerns although the term is rarely heard today, there was much concern in the 1970s about non-neutral decision-making by "single-value" regulatory agencies. 156 in the late 1960s and 1970s, congress created a number of new regulatory agencies-including the occupational safety and health administration, the consumer product safety commission, and the environmental protection agency-with narrow mandates to protect the public from one specific type of harm (for example, safety hazards in the workplace, dangerous products, or environmental contamination).157 the statutes creating these agencies gave regulators a single-value mandate to pursue one type of public benefit (such as worker safety) with no offsetting responsibility to administrative procedure, 91 harv. l. rev. 1805, 1812-14 (1978). 154 delong, supra note 115, at 260. 155 vermont yankee nuclear power corp. v. natural resources defense council, inc., 435 u.s. 519 (1978). 156 delong, supra note 115, at 278-79. 157 id. 400 vol. 10.2 why the common rule is hard to amend protect competing interests (such as industrial efficiency and economic growth). the 1974 and 1978 acts fell into this pattern of singlevalue legislation. both statutes created a mandate to protect human research subjects, with no offsetting responsibility to ensure the progress of the sciences. in the past, "delegations from congress to administrative bodies were presumed broad delegations to neutral experts under a general mandate to evaluate the public values involved in the same fashion as would the congress if it had the time and technical expertise of the administrative body."15 8 in contrast, the new single-value agencies were seen as inherently susceptible to bias because of their one-sided legislative mandates to pursue one value without regard to others. there was growing concern as the 1970s wore on that single-value agencies were prone to over-zealotry. by the late 1970s it was common for congress, when enacting single-value regulatory mandates, to impose special procedural constraints on agencies' rulemaking authority. "[tihe statutes granting power to such agencies, unlike the broader delegations to older agencies, are full of hedges and restrictions placing substantive or procedural limitations on the zeal with which the agency can pursue its reason for being."159 these constraints often included the formation of special-purpose commissions to ensure that countervailing interests would have a meaningful influence on the agencies' regulations. congress's use of the national commission and the president's commission exemplify this approach. congress closely controlled the interests that would be represented in this body. the 1974 act required five of the eleven posts on the national commission to be held by people who either were or had been involved in biomedical and behavioral research.160 congress thus gave an influential voice to persons likely to appreciate the benefits of research. by 158 delong, supra note 115, at 278. 159 id. at 279 (internal citations omitted). 160 national research act of 1974, pub. l. no. 93-348, § 201, 88 stat 342 (1974) (enacting 42 u.s.c. §§ 2891-1(b)(1)). 4012013 indiana health law review voting as a block and persuading just one other "nonresearch" member to join them, these five "pro-research" members would be able to muster a majority to support specific policy recommendations. the president's commission under the 1978 act continued in this vein. six of its eleven positions were reserved for persons with research experience or medical practice experience, with the five remaining positions set aside for ethicists, theologians, lawyers, natural and social scientists, public affairs specialists, and other non-research/nonmedical personnel. 161 the president was to appoint one member to serve as chairman with the advice and consent of the senate. this again displayed congress's wish to stay involved in setting directions for the commission. the quorum requirement for the president's commission was set at seven, 162 presumably to ensure that at least one nonresearcher/non-medical member would need to be present in order to conduct business. in our system of law, a duly elected legislature is empowered to set policy and strike a balance between competing interests. it was well within congress's power to tip the balance in a way that would limit the potential for research regulations to impede the progress of scientific research. the heavy representation of "pro-research" interests on the two commissions should be seen as a deliberate congressional decision to limit the potential for over-zealotry by a regulator that had been given a singlevalue mandate to protect human research subjects. carried to its logical extreme, this mandate might well imply not doing any research at all. that was not the balance congress intended to strike. rather than trust the regulator to strike an appropriate balance, congress struck a balance that gave significant weight to the social benefits of biomedical research. 163 the procedural constraints 161 42 u.s.c. § 300v (a) (2012). 162 id. at § 300v(d)(1). 163 see s. rep. no. 95-852, supra note 141, at 14 (reviewing the work of the national commission and noting that the senate committee on human resources was "particularly pleased that the commission has been successful in gaining the confidence and respect 402 vol. 10. 2 why the common rule is hard to amend embedded in the 1974 and 1978 acts were a way of implementing and preserving that balance. c special legal status of the 1978 regulatory recommendations the national commission's 1978 regulatory recommendations enjoy a special legal status even today. congress did not require the secretary of hew to implement all of these recommendations. to have done so may have raised concerns about inappropriate delegation of rulemaking authority to the private actors serving on the commission. 164 instead, the statute required the secretary to publish the national commission's regulatory recommendations in the federal register, to seek public comments, and to consider and formally respond to them.165 the statute gave the secretary two options for this response. the first option was that the secretary could deem the national commission's regulatory recommendations to be appropriate.166 if the secretary did so, then the secretary must, "as expeditiously as possible" take any administrative actions (such as promulgating a new regulation) the commission had recommended." 67 in other words, if the secretary deemed the recommendations appropriate, then the secretary was obliged to incorporate them into the common rule. the second option allowed the secretary to reject some or all of the commission's recommendations. the statute prescribed a process for doing so: the secretary must publish, in the federal register, a formal determination that the national commission's not only of the research community, but also of research-intensive industries such as the pharmaceutical industry"). 164 see, e.g., cospito v. heckler, 742 f.2d 72 (3rd cir. 1984) (finding no nondelegation problem in a situation where the secretary of hhs possessed final discretion to set standards, even though the standards had been informed by a private advisory body). 165 national research act of 1974, pub. l. no. 93-348, § 205, 88 stat 342 (1974). 166 id. 167 id. 4032013 indiana health law review recommendations are not appropriate "together with an adequate statement of the reasons" for this determination. 168 hew initiated proceedings in 1979 to incorporate the national commission's recommendations into its preexisting regulations at 45 c.f.r. pt. 46.169 these recommendations had a major impact on the common rule's substantive human subject protections and, in particular, influenced its framework of access to data and biospecimens. the following are several examples of how the recommendations influenced the common rule: (1) hew had not initially included a waiver provision in its proposed regulations, butbased on the national commission's findings 170-added one to the final regulation promulgated in 1981.171 that waiver provision was identical to the one that still exists in the common rule, 172 which has become an important pathway for unconsented access to data and biospecimens for research. (2) the national commission had focused mainly on ethical issues in clinical and behavioral research 73 but appointed a privacy protection study commission to examine research that uses existing documents, records, or biospecimens. 174 the national commission incorporated the privacy commission's 168 id. 169 proposed regulations amending basic hew policy for protection of human research subjects, 44 fed. reg. 47,688 (proposed aug. 14, 1979) (to be codified at 45 c.f.r. pt. 46). 170 hew, 1978 report, supra note 6, at 56,180-81 (discussing the need for consent waivers for certain types of research). 171 final regulations amending basic hhs policy for the protection of human research subjects, 46 fed. reg. 8366, 8390 (jan. 26, 1981) (to be codified at 45 c.f.r. § 46.117). 172 45 c.f.r. § 46.116(d) (2012). 173 see hew, 1978 report, supra note 6, at 56, 175 (discussing the national commission's scope of work). 174 id. at 56,181. 404 vol. 10. 2 why the common rule is hard to amend findings in its own regulatory recommendations.175 one of these findings was that "[if the subjects are not identified or identifiable, the research need not be considered to involve human subjects," and consent requirements should not apply. 176 in response to this recommendation, hew proposed the exemption that now appears in 45 c.f.r. sec. 46.101(b)(4).177 (3) the national commission specifically called for a mechanism to allow unconsented research access to identified data and records. 178 it found that even "where the subjects are identified, informed consent may be deemed unnecessary," if certain conditions are met.179 these included some conditions similar to the waiver criteria in today's hipaa and common rule waiver provisions, plus one very important condition that fell by the wayside and never was properly implemented.180 this omitted condition required that nonconsensual use of data and biospecimens be allowed only after a determination that "the importance of the research justifies such invasion of the subjects' privacy."181 this omission is a factor that has 175 itd. 176 itd. 177 see final regulations amending basic hhs policy for the protection of human research subjects, 46 fed. reg. 8366, 8371-73 (jan. 26, 1981) (discussing changes to the common rule's exemption provisions in reponse to the national commission's recommendations); id. at 8386-87 (implementing the exemption at 45 c.f.r. § 46.101(b)(4)). 178 hew, 1978 report, supra note 6, at 56,179-80. 179 id. at 56, 181. 180 see evans, supra note 5, at 120-24 (discussing the history of how hhs and later ocr failed to include, in the hipaa and common rule waiver provisions, the "public use" requirement that the commission had recommended-i.e., that unconsented uses should be allowed only if the use is found to offer important and justifying public benefits). 181 hew, 1978 report, supra note 6 at 56,179; see also hew, 1978 4052013 indiana health law review undermined public trust in the current framework for nonconsensual access to data and biospecimens and has contributed to the current pressures for reform. under the current regulations, members of the public have no assurance that such uses will serve any beneficial public purpose. 182 the procedural constraints in 42 u.s.c. sec. 300v-1(b) had a significant impact on the policies embodied in the present common rule. the anprm proposed to amend the exemption at 45 c.f.r. sec. 46.101(b)(4) and it sought public comment on possible changes to the common rule's waiver provisions. these changes potentially run counter to the 1978 regulatory recommendations. the anprm should have explained, yet failed to do so, why the secretary of hhs believes congress has authorized her to make such changes. d. why the common rule's consent provisions are hard to amend a challenge hhs faces today is that it is trying to keep its regulations up to date using authorities granted by an outdated statute. the 1978 act clearly envisioned an ongoing role for the president's commission it created: "the commission shall biennially report to the president, the congress, and appropriate federal agencies on the report, supra note 6 at 56,181 (reporting findings of a privacy protection study commission, under the auspices of the national commission, which elaborated this balancing requirement more specifically: "[medical records can legitimately be used for biomedical or epidemiological research, without the individual's explicit authorization," provided that the medical care provider (who in all likelihood would have been the data holder in that era of paper records) determines "that the importance of the research or statistical purpose for which any use of disclosure is to be made is such as to warrant the risk to the individual from additional exposure of the record or information contained therein," and that an irb ensures this condition has been met). 182 evans, supra note 5, at 77, 125-26. 406 vol. 10.2 why the common rule is hard to amend protection of human subjects of biomedical and behavioral research."183 those reports were to "include a review of the adequacy and uniformity" of federal rules, policies, guidelines and regulations, and could "include such recommendations for legislation and administrative action and the commission deems appropriate."18 4 the statute viewed the president's commission as an integral and ongoing part of the human subject protection framework. the president's commission would determine when the common rule was out of date and to recommend new legislation or administrative action to address the problem. unfortunately, the commission no longer exists. the statute offers no alternative pathway for updating the substantive ethical requirements of the common rule in its absence. congress may have planned on periodically authorizing the creation of new commissions to perform this function, just as congress had done when it replaced the 1974 national commission with the 1978 president's commission.185 if that was the plan, it fell off the tracks in the late 1980s. in 1985, congress enacted legislation18 6 to create a biomedical ethics board187 that was to "study and report to congress on a continuing basis on the ethical issues arising from ... biomedical and behavioral research, including the protection of human subjects of such research."188 unfortunately, this board "became politically deadlocked due to abortion politics, its appropriations were frozen, and finally its term expired in 1990."189 as bioethical issues became increasingly divisive, congress gave up creating statutory bioethics commissions to do the work of keeping the common rule up to date. hhs has been left to 183 42 u.s.c. § 300v-1(c) (2012). 184 id 185 id. § 300v-1(a). 186 health research extension act of 1985, pub. l. 99-158, 99 stat. 820 (1985). 187 id. § 11 (to be codified at 42 u.s.c. § 275). 188 id. (to be codified at 42 u.s.c. § 275(c)(1)). 189 susan cartier poland, hoetlics cbnm2ssons: tofwn meetings with a blue, blueriban' kennedy inst. of ethics j. (1998), at 12, available at http://bioethics.georgetown.edu/publications/scopenotes/ sn34.pdf. 4072013 indiana health law review regulate under a defective statutory framework that lacks a functioning process for amending the regulations. without the president's commission, it is genuinely debatable whether the secretary of hhs has any authority to amend the common rule's informed consent provisions. the statute at 42 u.s.c. section 300v-1(b) treats recommendations by the president's commission as events that trigger hhs's statutory authority to make rules that impose substantive ethical requirements on human subjects research (such as informed consent requirements). if there is no president's commission, there is seemingly no trigger that allows hhs to make rules that alter the common rule's informed consent requirements. the statute provides that, "[within 60 days of the date a federal agency receives a recommendation from the commission that the agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such recommendation in the federal register"190 and then "[wlithin the 180-day period beginning on the date of such publication, the agency shall determine whether the action proposed by such recommendation is appropriate." 191 thereafter, the agency must either take action-such as rulemaking-to implement the commission's recommendations or else publish a determination that explains why the recommendation is inappropriate. what does this mean in the context of present-day efforts to modernize the common rule? a narrow reading of the statute suggests that the secretary's authority to make substantive ethical rules comes into being only immediately after the commission issues a recommendation within 60 days.192 by this view, congress delegated to the commission the task of developing substantive ethical policies to be included in the common rule. the secretary of hhs was granted nothing more than a constrained authority to respond to those recommendations, and this was a one-time delegation of authority for the purpose of establishing the common rule as it now exists. therefore, 190 42 u.s.c. § 300v-1(b)(1). 191 id. § 300v-1(b)(2). 192 id. § 300v-1(b)(1). 408 vol. 10. 2 why the common rule is hard to amend there is a real question whether hhs has any authority to implement the anprm's proposed informed consent policies. any amendment to the common rule's informed consent requirements would require further action by congress. an alternative but somewhat less persuasive reading is that the "within 60 days" language was simply to ensure prompt action to implement the commission's recommendations after they were first issued, but was not intended to preclude later action by the secretary to respond to those same recommendations. as a result, the secretary of hhs would have ongoing authority to respond to the commission's recommendations, provided she follows the procedural constraints set out in 42 u.s.c. section 300v1(b)(2). furthermore, if the secretary's proposed amendments go against the 1978 regulatory recommendations, hhs first would need to publish a reasoned determination explaining why those recommendations are no longer appropriate. 193 this procedural step was ignored during efforts to develop the recent anprm. if the anprm proceeds to a rulemaking that amends the common rule in ways that contravene the 1978 regulatory recommendations, those amendments can be challenged as having violated the statutorily prescribed procedures. there have, of course, been many subsequent bioethics commissions, secretary's advisory committees, and even president's commissions addressing various aspects of human subject protection.194 the mere fact that later bioethics advisory bodies addressed similar subject matter does not, however, make them legal successors to the president's commission that congress created in 1978. to be a legal successor would mean that the recommendations 193 id. § 300v-1(b)(2)(a). 194 see former bioethics commissions, president's council on bioeihics,httpilbioethics.georgetown.edu/pcbe/reports/past commissions (last visited mar. 13 2013) (listing all former u.s. national bioethics commissions); see also poland, supra note 189 at 11-13 (discussing prior bioethics commissions and providing a bibliography of their work products). 4092013 indiana health law review of a later body would enjoy the special legal status described in 42 u.s.c. sec. 300v-1(b): the secretary must either find the recommendations appropriate and implement them or else publish a reasoned determination rejecting them. the work of later commissions and advisory bodies lacks this special status because of the way those bodies were formed. these later bodies were created by executive order, 195 pursuant to other, unrelated statutes or under the secretary of hhs's general authority.196 so formed, these bodies are not legal successors to the two commissions that congress authorized by statute in 1974 and 1978. for example, the current secretary's advisory committee on human research protections is merely an advisory committee formed at the discretion of the secretary of hhs rather than by congress.197 the 1978 act expressly envisioned that such advisory committees could exist alongside the president's commission formed under that legislation but did not regard them as substitutes for it.198 to create a new commission whose recommendations would enjoy the same legal status as the 1978 regulatory recommendations seemingly would require another act of congress. until that happens, the regulatory recommendations of the 1974 national commission, as endorsed by the 1978 president's commission, have an enduring legal significance, just as the belmont report has an enduring ethical significance today. the 1978 regulatory recommendations establish congressionally authorized parameters for human subject regulation and they limit the 195 see, e.g., executive order 12975, 60 fed. reg. 52063 (oct. 3, 1995) (creating the clinton administration's national bioethics advisory commission); executive order 13237, 66 fed. reg. 59851 (nov. 28, 2001) (creating the bush administration's president's council on bioethics); executive order 13521, 75 fed. reg. 62671 (nov. 24, 2009) (creating the obama administration's presidential commission for the study of bioethical issues). 196 42 u.s.c. § 217a (2012). 197 see secretary's advisory committee on human research protections, hhs.gov, http://www.hhs.gov/ohrp/sachrp/charter/index. html (last visited mar. 14, 2013). 198 42 u.s.c. § 300v-1(a)(3) (2012). 410 vol. 10.2 why the common rule is hard to amend discretion of agency secretaries to amend the common rule. how, then, can the common rule be modernized? the statute requires input from a commission that no longer exists. into this gap, the anprm presumed that hhs has authority to update the common rule on its own, yet the statute does not appear to give hhs this authority. the chevron'99 and meac 00 framework of deference treats agencies as the most appropriate bodies to interpret the meaning of agencies' own enabling statutes. courts must apply chevron's deferential two-step analysis201 in reviewing agencies' interpretations of their own enabling statutes; however, this is true only if the agency advances its interpretation in the context of a notice-and-comment proceeding and if the agency is acting pursuant to a congressional delegation of lawmaking authority.202 the problem with the anprm is that hhs appears to have been acting without a delegation of lawmaking authority. therefore, it seems doubtful that the anprm's presumption of rulemaking authority will be entitled to chevron deference. eskridge and baer point out that there are "a number of precedents where the court has taken a non-deferential approach to agency interpretations of their own jurisdiction or authority."203 the authors found that the court applied chevron deference only about one-third of the time in such situations. 204 199 chevron, u.s.a., inc. v. natural res. def. council, 467 u.s. 837 (1984). 200 united states v. mead corp., 533 u.s. 218 (2001). 201 see chevron, 467 u.s. at 842 (directing courts, as the first step, to assess whether congress has "directly spoken to the precise question at issue" and, if so, to be guided by the statute or, if not, to proceed to step two). see also chevron at 843 (directing courts, in step two, to inquire whether the "agency's answer is based on a permissible [i.e., not necessarily the best] construction of the statute" and, if so, to defer to it). 202 mead, 533 u.s. at 226-27, 230-33. see also gonzales v. oregon, 546 u.s. 243, 259 (2006). 203 william n. eskridge, jr. & lauren e. baer, the continuum of deference: &pmme 6burt deatment of agency satutazy interpetations fam chevmn to hamdan, 96 geo. l.j. 1083, 1130 (2008). 204 id. at 1131 (finding chevron deference applied in 34.4% of cases 4112013 indiana health law review it may indeed be unreasonable for congress to have left a major federal regulation bereft of a functioning mechanism through which the regulation can be amended. that fact does not, however, imply that hhs has rulemaking authority by default. with no commission in place to trigger hhs's authority to amend the common rule's informed consent requirement, it may simply be that nobody has a valid delegation of the necessary rulemaking authority. the anprm presumed that hhs could fill the gap. rather than defer to the agency's interpretation, courts may see this as a problem that only congress can solve. v. conclusion nobody denies that the common rule is ripe for modernization. the question is how to devise an appropriate process for doing so, given the constraints imposed by earlier statutes. developing appropriate policies on informed consent to the use of data and biospecimens is not just a normative bioethical inquiry; it is also a legal inquiry that requires close attention to process and procedure and may require congressional action to resolve. here once again it is useful to view the 1978 act in the context of its time. an influential strand of contemporary (1980s) commentary viewed congress's creation of special commissions as a check on unfettered agency discretion that could produce "policy drift."2 0 5 the concern was that agency rulemaking might, over time, produce policy outcomes at odds with compromises struck during passage of the original enabling legislation. commissions, it was believed, could help keep agency rulemaking responsive to the with less stringent deference, or no deference, applied in the other 65.5% of cases). 205 see, e.g., barry r. weingast & mark j. moran, bureaucratic discretion or congressional control? regulatory policymaking by the federal trade commission, 91 j. pol. econ. 765 (1983) (advancing this theory); matthew d. mccubbins, roger g. noll, barry r. weingast, strctuw and pnxss poltis and poli cyha2nistivetaagements and the potial contrl ofagences 75 va. l. rev. 431 (1989) (same); craig n. oren, clearing the air: the mccubbins-noll-weingast hypothesis and the clean air act, 9 va. envtl. l. j. 45 (1989) (challenging this view). 412 vol. 10. 2 why the common rule is hard to amend interests of the coalition that had been instrumental in passing the legislation. the statute at 42 u.s.c. sec. 300v1(b)(2) forced agencies that implement the common rulepresent and future-to stop and consider the balance struck when congress authorized rulemaking in this area. congress presumably understood that conditions can change, possibly requiring a new balance to be struck in future times. section 300v-1(b)(2) was a message from congress to the future: if you want to strike a new balance, you must jump over some extra procedural hurdles and, possibly, enlist the involvement of congress at that future time. congress never fully authorized the secretary of hhs to strike the balance between the individual's right of informed consent and the public's interest in the advancement of science. congress entrusted the task of striking that balance, in the first instance, to its two statutorily created commissions. congress also signaled its desire to remain involved, if future developments evolve in ways that the two commissions failed to contemplate. this raises the possibility that legislative action may be required in order to implement the reform program that the anrpm proposed. if that is the case, there are various options for modernizing the common rule. one option, of course, is to ask congress to amend 42 u.s.c. section 300v-1(b). such amendments could grant the secretary of hhs unconstrained authority to make regulations that establish informed consent policy. if that approach is unavailing, that is not necessarily the end of reforms. the secretary of hhs has significant discretion to make the common rule function better without amending the regulatory text itself. 206 the common rule is indeed hard to amend, but there are promising pathways for implementing sound policies within the framework of the existing regulation. 207 skillful 206 evans, supra note 5, at 129-130. 207 id. (discussing the use of discretionary authority the secretary already possesses under 45 c.f.r. § 46.101(c) and exploring potential uses of interpretive guidance and creation of safe harbors that create strong incentives for voluntary compliance with desired norms). see 4132013 indiana health law review use of these other approaches may avoid the need for regulatory amendments that may, in the end, prove unlawful. also comments of barbara j. evans, dkt. no. hhs-ophs-2011-0005, 76 fed. reg. 44, 512 (oct. 25, 2011), available at http://www.regulations. gov/#!documentdetial:d=hhs-ophs-2011-0005-0822 (citing the example of fda's use of guidance in 2006 to elicit voluntary compliance with new privacy protections for biospecimens in return for an exercise of fda's enforcement discretion). 414 vol. 10.2 burden of deciding for yourself: the disutility caused by out-of-pocket healthcare spending, the the burden of deciding for yourself: the disutility caused by out-of-pocket healthcare spending christopher t. robertson* and david v. yokum** i. introduction .................................. 610 ii. mapping the normative objections to costsharing ....................................... 612 a. underinsurance ...................... ..... 612 b. reductions in high -value healthcare.... ..... 613 c, the unfair tax on sickness..................615 d. decisional burden .................... ..... 617 iii. the alternatives to cost sharing .............. 618 a. alternative world #1: outsourcing the rationing function ..................................... 618 b. alternative world #2-' forgo rationing.... ..... 621 iv. evaluating the decisional burden ............. 622 a. choice overload...........................623 b. depletion of cognitive capacity .............. 627 c. facilitation ofregret ................. ...... 631 v. conclusions .............................. ..... 634 as part of a larger "consumer-directed healthcare movement," cost-sharing mechanisms, such as copays and deductibles, cause patients to pay out of pocket for a portion of the costs of the healthcare they consume. cost sharing is jd, phd, associate professor at the james e. rogers college of law, university of arizona. robertson wrote this piece while a visiting professor at harvard law school. he may be reached at crobertson@post.harvard.edu. this paper is part of a symposium on "patient's responsibility for health care," and the authors thank the organizers, including the student editors and professors nicolas terry and david orentlicher, who kindly invited us to participate. jd, ma, mva, doctoral student in psychology at the university of arizona and a fellow of the u.s. social and behavioral sciences team. the opinions expressed in this paper are those of the authors in their individual capacities. indiana health law review intended to reduce costs by changing consumption behavior, and it has been shown to be an effective though incomplete solution to the problem of unsustainable cost growth. it is controversial nonetheless. this essay distinguishes three different normative problems with cost sharing (including underinsurance, deterrence of high-value care, and a tax on sickness), which can all be fixed through more precision in the design of cost-sharing mechanisms. this essay provides the first sustained investigation of a fourth problem, "the decisional burden." by setting aside the three foregoing problems and then carefully specifying two alternative counterfactual situations in which costsharing obligations are removed, the analyst can precisely identify the remaining causal impacts of cost sharing, namely: a subjective disutility experienced by patients when navigating a difficult, and potentially unwanted, choice amongst a complex set of options, requiring tradeoffs between health and wealth. several concepts from the behavioral sciences-cognitive capacity, choice overload, sunk costs, and regret-shed light on this problem. this essay reviews select portions of that literature and concludes that the decisional burden is a real disadvantage of using patient cost sharing as a mechanism for rationing healthcare. advocates of cost sharing must bite this bullet. nonetheless, the behavioral science results are descriptive, not prescriptive. in a world of epistemic uncertainty and heterogeneity of values, it is not irrational for consumers to prefer cost-sharing-if carefully designed and implemented-as the least-bad rationing mechanism among the alternatives, which either reduce access to healthcare or sink costs for unwanted healthcare. ultimately, the burden of deciding for yourself is the burden of being an autonomous person. i. introduction over the last several decades, deductibles, copays, coinsurance, reference pricing, and other forms of cost sharing have become a primary tool to reduce the cost of vol. 11:2610 out-of-pocket healthcare spending health insurance.' cost sharing has both a distributional function (as to how much the insurer versus the patient pays at the point of consumption), and a behavioral function (as to whether the patient chooses to consume versus decline certain healthcare).2 the behavioral function is a form of distributed rationing, since it asks the patient to determine whether the healthcare in question is worth the cost exposed to the patient. if cost sharing can reduce consumption of healthcare, or shift patients towards less expensive forms of healthcare, it may then reduce the cost of insurance premiums ex ante. it may also counteract some of the pro-consumption biases that currently exist in the healthcare system, making the economy more efficient, as individuals trade for other healthcare and other forms of non-healthcare consumption that deliver higher value.3 the increasing use of cost sharing has been controversial, however. there are practical problems with making cost-sharing work, most notably the lack of pricetransparency in the american healthcare market. 4 if patients are unaware of the exposed costs associated with each treatment option, they are then unable to perform the cost-benefit analysis that cost sharing presumes. states are legislating, federal officials are investigating, and entrepreneurs are starting new enterprises, all seeking to improve this situation. 1 kaiser family foundation, employer health benefits 2012 annual survey 4 [hereinafter kff 2012 survey], available at http://kff. org/private-insurance/report/employer-health-benefits-2012-annual-survey/ ("most covered workers face additional plan costs when they use health care services."), archivedathttp://perma.cc/uyv7-hs7n. 2 christopher t. robertson, scaling cost-sharing to wages, 14 yale j. health pol'y l. & ethics (forthcoming 2014). 3 christopher robertson, the split benefit: the painless way to put skin back in the healthcare game, 98 cornell l. rev. 921 (2013). 4 see uwe e. reinhardt, the pricing of us hospital services: chaos behind a veil of secrecy, 25 health aff. 57 (2006); peter a. ubel et al., full disclosure out-of-pocket costs as side effects, 369 new eng. j. med. 1484 (2013) (arguing that physicians have a duty to provide such price information to patients, and discussing state legal mandates for price transparency). 2014 611 indiana health law review ii. mapping the normative objections to cost-sharing from a normative perspective, there are four primary objections to cost sharing. most of these are objections to the relatively crude design of extant cost-sharing policies, which may be addressed by contemporary and future reforms. the final concern about subjective disutility is our focus here, but it is best understood in contradistinction to these other concerns. a. underinsurance an initial concern is that cost sharing may be so large in comparison to the patient's wealth that it undermines the core functions of insurance, namely, guaranteeing access to care and protection from financial risk. 5 after all, cost sharing is just a way of saying that the patient retains exposure to some of the risk of illness. this phenomenon is called "underinsurance": if patients cannot afford the costsharing burden imposed by their health insurance problems, then they effectively lose access to the healthcare, or they stretch and find themselves in bankruptcy or foreclosure.6 5 see generally m. gregg bloche, consumer-directed health care and the disadvantaged, 26 health aff. 1315, 1318 (2007). 6 see rashid bashshur et al., defining underinsurance: a conceptual framework for policy and empirical analysis, 50 med. care rev. 199 (1993); cathy schoen et al., how many are underinsured? trends among us. adults, 2003 and 2007, 27 health aff. w298 (2008), http://content.healthaffairs.org/content/27/4/ w298.full.pdf, archived at http://perma.cc/7cw9-ywfr; david u. himmelstein et al, medical bankruptcy in the united states, 2007: results of a national study, 122 am. j. med. 741, 744-45 (2009) (finding that 62% of bankruptcies had medical causes, including but not limited to out-of-pocket spending, and that of 78% of those filers had medical insurance at the start of their illness); see also tal gross & matthew j. notowidigdo, health insurance and the consumer bankruptcy decision: evidence from expansions of medicaid, 95 j. pub. econ. 767 (2011) (a quasi-experimental study finding that out-of-pocket medical costs roughly account for 26% of personal bankruptcies among low-income households); christopher robertson et al.,. get sick, get out: the medical causes of home foreclosures, 18 health matrix 65, 90-94 (2008) (survey finding that more than half of foreclosures had medical causes). vol. 11:2612 out-of-pocket healthcare spending such financial distress may also lead to psychological stress and related problems. if difficulty paying is correlated with class, race, or ethnicity, then this underinsurance problem may also exacerbate disparities in healthcare.7 in other work, robertson has suggested two ways in which this very serious problem can be addressed through careful design of cost-sharing policies. first, insurers can scale cost-sharing obligations to the wealth of individual beneficiaries, so the remaining exposed risk is proportionate to the ability of patients to bear that risk.8 second, for very expensive treatments and for poorer patients, cost sharing can still be used, without creating underinsurance, through a novel design that we have elsewhere proposed and tested. the insurance benefit can be "split" between the patient and the provider, so a portion is transferred as wealth to the patient, who pays that portion to the provider upon choosing to consume. this "split benefit" thus forms a costsharing obligation and-most importantly-an opportunity cost, which does not depend on the patient's own prior wealth. 9 at least analytically, these sorts of potential solutions to the underinsurance problem allow a sharper focus on the other problems associated with cost sharing. b. reductions in high -value healthcare a second concern is that, in addition to its intended behavioral function of discouraging consumption of lowvalue healthcare, cost-sharing obligations may cause patients to decline beneficial healthcare that they would be better off consuming. 10 this objection is essentially paternalist."l the problem has been observed in empirical 7 see bloche, supra note 5, at 1316. 8 see generally robertson, supra note 2. 9 see generally robertson, supra note 3. 10 see kathryn swartz, robert wood johnson foundation research, research synthesis report no. 20, cost-sharing: effects on spending and outcomes 1 (2010); dahlia k. remler & jessica greene. cost-sharing: a blunt instrument, 30 ann. rev. pub. health 293 (2009). 11 einer elhague, allocating health care morally, 82 cal l. rev. 1457, 1480 (1994) (discussing that paternalism "actually motivates 2014 613 indiana health law review research, most notably the rand health insurance experiment. cost sharing reduced consumption of healthcare that analysts coded "high value," along with the healthcare they coded as "low value." however, for the median patients, the declining of such "high-value" care does not consistently worsen health outcomes. 12 that disconnect between consumption behavior and health outcomes suggests that the declined "high-value" care may not have been so worthwhile after all. still, for the subset of participants who were poorest, the cost-sharing burden caused an even greater reduction in consumption of seemingly "high-value" care, and did worsen health outcomes. thus, this problem may also be a species of the underinsurance problem. to the extent that this objection is distinct from the prior one, it must be assumed that the cost-share is perfectly affordable. the distinct point is that even patients who can perfectly well afford to pay the cost share may nonetheless fail to make the optimal consumption decisions, due to their exposure to that price. from a theoretical perspective, cost sharing often exposes patients to only a small portion of the costs of healthcare (18% is a typical coinsurance rate), so this normative concern must presume that patients make radical errors towards non-consumption when making the cost-benefit tradeoffs (supposing that even 18% of the costs outweigh the benefits).13 robertson has argued elsewhere that we generally lack the epistemic and normative basis to make such a paternalistic critique of patients' decisions to decline care. 1 4 especially for the 5% of most expensive healthcare, which drives most aggregate healthcare spending, a policy analyst simply cannot say that the benefits of the declined healthcare would have exceeded its costs and risks. indeed, we should presume the contrary. policymakers to refuse to simply redistribute cash: the poor, many believe, would irrationally spend money on the wrong things"). 12 joseph p. newhouse, free for all? (1993). 13 see kff 2012 survey, supra note 1, at 121, exh. 7-21 (showing the 18% figure). 14 christopher t. robertson, a presumption against expensive healthcare consumption,49 tulsa l. rev. 627 (2014). 614 vol. 11:2 out-of-pocket healthcare spending thus, this paternalist critique bears a heavy burden of persuasion that is rarely met. nonetheless, in such cases where that burden has been met-such as where it is important that patients adhere with a proven drug regimen-this problem can also be addressed through careful insurance design. in recent years, scholars have developed a "value-based insurance" model, in which costs sharing is reduced or eliminated for healthcare that is known to be beneficial to the patient and cost saving on net. 15 thus, in cases where we know that healthcare should be consumed, cost sharing can and should be simply waived. c the unfair tax on sickness a third normative concern is that cost sharing is unfair to those who are sick because it disproportionately places upon them the burden of paying for sickness in a society. if one conceives of sickness as simply an unlucky draw from the genetic lottery, or a broader lottery that includes other disease vectors, then it may seem unfair for sick individuals to bear part of their own healthcare costs, while the luckily healthy bear no such costs. here, sickness is understood as a social burden not an individual burden. 16 this is potentially a profound objection because it draws upon fundamental conceptions of justice and the purpose of insurance. a complete analysis of this objection is not possible here, but a few points are worthwhile. first, of course, not all sickness is caused by random factors. lots of healthcare 15 michael chernew et al., value-based insurance design, 26 health aff. w195, w195-w196 (2007). 16 see allison k. hoffman, three models of health insurance: the conceptual pluralism of the patient protection and affordable care act. 159 u. pa. l. rev. 1873, 1922-32 (2010) (discussing "brute luck" theories of health insurance). for a proponent of such a theory, see, e.g., shlomi segall, is health (really) special? health policy between ra w1sian and luck egalitarian justice, 274 j. applied phil. 344 (2010) (arguing for public funding of breast reduction surgery, skin color change treatments, gender reassignments, and even surgery to allow male pregnancy, if possible). 2014 615 indiana health law review expenses are driven by choices individuals make for themselves. as long as cost sharing is driven by prospective behavioral justifications, rather than theories of moral desert, we need not untangle this problem of mixed causes. but those who raise this profound critique of cost sharingsaying that the burden is undeserved (always or in certain situations)-would need to untangle these causes.17 second, cost sharing only imposes a small portion of healthcare expenses on the individual sick patients; the remainder of the expenses are redistributed to the other members of the insurance pool. overall, in the typical employer-sponsored plan (the primary source of insurance in the united states), the employees bear about 7% of the cost of healthcare at the point of consumption; the remaining 93% is borne by the insurer.'8 thus, the sick do receive a huge redistribution (subsidy) that compensates for their unluckiness. that is the very purpose of insurance: to redistribute risk. third-and most importantly-if an insurer solves the underinsurance problem discussed above, so that each individual is exposed only to the amount of risk that is bearable, it is hard to motivate a theory of justice that would require redistribution of bearable risks. after all, individuals are exposed to all sorts of bearable risks in the modern society-everything from the mundane risks, such as the need for plumbing repair or roadside assistance for a flat tire, to more substantial risks, such as having the value of one's house decrease. americans do not typically suppose that justice requires that these risks be redistributed, at least as long as they are small enough to be bearable. for these reasons, it seems that this "unfair tax on sickness" objection is a species of the underinsurance objection, which can and should be resolved through more precise design of insurance policies.' 9 17 see dan wikler, who should be blamed for being sick?, 14 health educ. & behav. 11 (1987). 18 chris peterson, cong. research serv., r4049, setting and valuing health insurance benefits (2009). 19 similarly, see bloche, supra note 5, at 1325 ("medical coverage is more than a business proposition; it is an expression of our 616 vol. 11:2 out-of-pocket healthcare spending d. decisional burden a fourth concern is our focus here. even if patients can afford the cost-sharing burden (which is to say that they are not underinsured), it may still be stressful and otherwise psychologically burdensome for patients to think about those costs when making decisions, or to even actively engage in the making of decisions at all, rather than simply deferring to their physicians. out-of-pocket expenses may make healthcare decisions more difficult, in part because it adds a criterion that is possibly incommensurate with the others being considered. bruce vladek has suggested such an analysis: consumers . .. don't wish to be forced to make rational trade-offs when they are confronted with medical care consumption decisions. [medical care is about living and dying, something considered by many to be of a rather different character from the purchase of tomatoes. the primary characteristic of most consumers of medical care most of the time is that they are scared. they are scared of dying, or disfigurement, or permanent disability; and these are serious matters. 20 in this sense, a cost-sharing burden makes the patient's healthcare decisions-which are already profoundly difficult, as they are made in the grips of scientific uncertainty with existential questions about whether and how to live-even more difficult. this difficulty can lead to stress, lack of certainty, cognitive load, and other disutility. although mentioned by several scholars and commentators, this "decisional burden" concern has tended to be conflated with other concerns about cost sharing, and, thus, received commitment to each other. cost sharing that renders high -value care unaffordable breaches this commitment") (emphasis added). 20 bruce vadeck, the market v. regulation: the case for regulation, 59 milbank q. 209, 210-11 (1981). 2014 617 indiana health law review virtually no sustained investigation of its own.21 it is our focus here. iii. the alternatives to cost sharing to weigh this concern about decisional burden in the domain of bearable costs, a policymaker or an insurance buyer would need to compare the disutility associated with decisional burden with the costs of alleviating that burden. the amount of disutility is an empirical question explored below, one that will likely vary across patients and across the various sorts of treatment decisions that will be made. to understand whether, how, and to what extent cost sharing actually creates decisional burden disutility, it is useful to identify the counterfactual world that would obtain without cost sharing. we have suggested above that cost sharing is a form of "rationing," since it asks the patient to determine whether the healthcare in question is worth the cost exposed to the patient. in principle, there are two different ways that the decisional burden could be eliminated: (a) outsource the rationing function, which will likely reduce the choice set of treatments available to the patient at the point of consumption; or (b) stop rationing altogether and thereby increase the costs of insurance premiums (or tax outlays) ex ante. we consider each below. a. alternative world #1. outsourcing the rationing function the first alternative to cost sharing is to outsource the rationing function to someone else-whether it is the physician, the insurer, a government regulator, or some third party to receive the pricing information and then decide whether the treatment's benefits to the patient are worth its cost to the insurer. 22 there are then two ways to conceive the rationer's mission. 21 see generally swartz, supra note 10; remler & greene, supra note 10. 22 this is no easy task. see einer elhauge, the limited regulatory potential of medical technology assessment, 82 va. l. rev. 618 vol. 11:2 out-of-pocket healthcare spending one way is that the optimal rationer could be given the mission of replicating the decisions that the individual principal would have made if he or she had been exposed to price. this is similar to one conception of the way healthcare proxies are supposed to work for incompetent patients. 23 in this "patient proxy" conception of rationing, the rationer would hold the cost of insurance premiums constant (since consumption is unchanged from the costsharing world) plus some additional marginal cost for paying for the services of the rationer. those marginal costs could be quite high since the rationer is providing decisions customized to the personal values and clinical situations of each individual patient. on this conception of the outsourced rationer, the patient's personal autonomy is theoretically infringed because he or she is denied other options, but the denial is trivial if we assume arguendo that the rationer properly predicts that he or she would not have chosen those other options anyway. of course, such a conception of the outsourcing of the rationer's mission is complicated by principal-agent problems. in the weighing of costs and benefits, it may be difficult to align the decisions of those rationers with the patient's own interests. for example, if the rationer is affiliated with the insurer, the rationer may be more concerned with the costs of treatments than their benefits to the patient. 24 more fundamentally, even if properly motivated, it may be difficult for the rationing agents to assess the principal's individualized interests and values.25 1525 (1996) (describing the profound normative and epistemic difficulties); robertson, supra note 3, at 921, 931-43 (2013) (explaining the problems with physician rationing and insurer rationing). 23 see tom l. beauchamp & james f. childress, 'iespect for autonomy" in principles of biomedical ethics 120-88 (4th ed. 1994). 24 see mark a. hall & gerard f. anderson, health insurers' assessment of medical necessity, 140 u. pa. l. rev. 1637, 1668 (1992). see generally jay m. feinman, delay, deny, defend: why insurance companies don't pay claims and what you can do about it (2010) (discussing insurers' tactics of delaying or denying justified claims and forcing policyholders to litigate). 25 see einer elhauge, allocating health care morally, 82 cal. l. rev. 1450 (1994) (suggesting that a diversity of insurance plans could 2014 619 indiana health law review more realistically, then, the rationer would likely not follow such a patient-proxy algorithm. instead (and this is the second conception), the rationer would use its own costbenefit assessments, and then create a subset of all possible treatment options that survive the rationing test. this reduced menu would be presented to the patient for binary choices of whether to accept or decline on the basis of nonfinancial considerations. this solution has the immediate consequence of reducing the patient's autonomy and access to healthcare, since there will be instances in which the outsourced rationer excludes treatments from the choice set (i.e., declines care) that the patient him or herself would have preferred to consume. often, indeed, the patient's choice set will be reduced to a single option, which the patient can take or leave. if the decisional burden were very severe, it may be rational for a person to make such a trade ex ante, giving up some control over healthcare decision making in order to avoid the burdens of exercising that control. it is also possible that this rationer will on net decline more (or less) care than the patients would have done under a world of cost sharing, which, thus, could cause insurance premiums to go down (or up). assuming, however, that the rationer is roughly accountable (through democratic or market mechanisms), let us suppose the premiums are held constant. it is also possible that an outsourced rationer would make better decisions on the merits than patients would make for themselves. 26 this phenomenon would be a species of the second problem, set aside above. 27 be created, reflecting different rationing priorities, from which insurance buyers could select ex ante); see also russell korobkin, comparative effectiveness research as choice architecture: the behavioral law and economics solution to the health care cost crisis, 112 mich. l. rev. 523 (2013) (similar). 26 see george loewenstein et al., can behavioural economics make us healthier? 344 bmj 1, 2 (2012) (discussing britain's national institute for health and clinical excellence (nice), "which makes national decisions regarding the cost effectiveness of treatments and ensuing coverage" as an example of a "good shove that advances individual and social welfare considerably more" than a nudge). 27 see part ii.b above. 620 vol. 11:2 out-of-pocket healthcare spending b. alternative world #2' forgo rationing the second alternative is to loosen the constraint on insurance premiums and forego the price signal rationing function altogether. as vladek has suggested, "[als a society, we may be prepared to pay a substantial economic premium to insulate people from having to make such decisions." 28 under such a policy, the patient could consume any healthcare she desired with absolutely nobody paying attention to its cost. under this regime, the cost of health insurance premiums would, thus, be higher than in situations where someone is performing the rationing function. the insurance premiums would be inflated in two ways: first, more healthcare would be consumed, and second, the producers and providers of that healthcare would significantly increase their prices charged since they would not be competing along the dimension of price. these higher prices might make health insurance unaffordable ex ante or, even if affordable, would force tradeoffs between other spending priorities (e.g., housing or nutrition) against the marginally higher health insurance premiums. in this sense, insurance creates a sunk cost: the patient pays ex ante for healthcare that she would not choose to consume ex post if she had to bear those costs at the point of consumption. this is a waste, which is a prima facie harm to the consumer. 29 for present purposes, let us set aside redistributional policies and assume that the patient bears these ex ante costs, which implies that he or she has less disposable 28 see viadek, supra note 20, at 212. 29 moral hazard is the problem that the fully insured purchaser bears none of the costs at the point of consumption. if consumers conceive of their health insurance as a prepayment of a right to consume healthcare, then it may also give rise to the sunk cost fallacy. under this fallacy, a consumer is more likely to consume, potentially even selecting an otherwise suboptimal choice, based on the sense that her own prior investment would be wasted if she did not consume the pre-purchased goods. we are unaware of these two potential confounding effects being disambiguated -in the health insurance domain. 2014 621 indiana health law review wealth at the point of consumption. nonetheless, let us also assume that insurance is somehow sustainable even without rationing, so we can hold coverage constant for the individual. these assumptions may not be realistic for all patients, of course. iv. evaluating the decisional burden to summarize the prior part: in the first alternative to cost sharing, the rationing decision is outsourced, and, then, the patient makes consumption decisions-among a potentially reduced choice set-without regard to the price. in many instances, the patient will have no choice among alternative treatments at all. in the second alternative to cost . sharing, a patient makes consumption decisions without regard to price and has a full range of choices but, also, less wealth. in light of these counterfactuals, research from the behavioral sciences, notably the field of judgment and decision-making, sheds light on the decisional burden potentially associated with cost-sharing mechanisms. we review some of this literature, trying to draw analogies to cost sharing, and drawing on the medically related literature in particular. notably, however, we have found no direct study of these phenomena in the cost sharing setting in particular. the burden might be exacted in at least two forms: first, the quality of the decision itself might be worsened, and, second, even if choice quality is not objectively worsened, the decision maker may come to personally feel less satisfied with the choice. we approach these issues from several angles. we begin by considering how features of the choice set affect decision-making. specifically, additional choices can, somewhat paradoxically, actually worsen decision quality and satisfaction. we then turn to consider characteristics of the decision maker. our case study is cognitive capacity and, in particular, how consideration of stressful financial constraints can itself deteriorate cognitive performance. finally, we examine how vol. 11:2622 out-of-pocket healthcare spending outsourcing a decision avoids the potential for regret, especially of a self-blame variety. a. choice overload outsourcing the rationing function has the ultimate effect of reducing the number of options available to the patient at the point of consumption (because the rationer screens out options according to its own cost-benefit analysis). this reduction is, prima facie, undesirable. there is an intuitive pull to believe that more choice is always a good thing-or at least never a bad thing.30 yet a variety of experimental and field studies have revealed a "paradox of choice," wherein the availability of more choice options actually decreases decision quality and satisfaction.31 sheena lyengar and mark lepper, in now-famous work, provided several controlled experimental examples of the phenomenon.32 in one study, they found that customers at an upscale grocery store were more likely to sample jams from a choice set of twenty-four flavored jam possibilities, but, paradoxically, they were actually more likely to purchase a jam when confronted with a limited set of six flavored jams only. a second study found that undergraduate students were more likely to complete an extra credit essay, and that the essays were of higher quality, if the instructor afforded only six rather than thirty topic possibilities. subjects in a third study selected from a choice set of either six or thirty chocolates. those in the 30 e.g., eduardo porter, the more choice the better: yes, no or maybe?, n.y. times (mar. 29, 2005), http://www.nytimes.com/2005/03/28/world/americas/28iht-choice.html?_r=0 ("if you were to walk into a wal-mart and say to people, 'don't you feel really depressed by having 258,000 options; shouldn't it be their obligation to reduce the choice you must endure?' they would think you were nuts.") (quoting newt gingrich, former speaker of the house of representatives), archived at http://perma.cc/7wqn-ladz 31 see generally barry schwartz, the paradox of choice (2009). 32 sheena s. iyengar & mark r. lepper, when choice is demotivating can one desire too much of a good thing?, 79 j. personality & soc. psychol. 995, 995-1004 (2000). 2014 623 indiana health law review limited-choice set condition were more satisfied with the taste of their chosen chocolate and experienced less regret than their counterparts confronted with the larger array of chocolates. based on these results, the authors postulated a "choice overload hypothesis," namely, that "although the provision of extensive choices may sometimes still be seen as initially desirable, it may also prove unexpectedly demotivating in the end."3 3 subsequent empirical work has confirmed the problem of choice overload in more naturalistic settings. proctor & gamble experienced a 10% increase in sales after it reduced the number of versions of head and shoulders shampoo from twenty-six to fifteen. 34 lyengar et al. examined enrollment rates in the 401(k) retirement benefit plans of, approximately, 800,000 employees in 650 plans across seventy industries, as a function of the number of plan options offered (which ranged from two to fifty-nine). 35 carefully controlled regression analyses revealed that, all else equal, the addition of every ten funds was associated with a 1.5-2.0% reduction in enrollment. participation was highest when only two options were offered (75%), but lowest when fifty-nine funds were available (60%). 33 see also avni m. shah & c. keith wolford, buying behavior as a function of parametric variation of number of choices, 18 psychol. scl. 369 (2007) (pens); alexander chernev, the role of purchase quantity in assortment choice: the quantity-matching heuristic, 45 j. marketing res. 171 (2008) (chocolates); elena reutskaja & robin m. hogarth, satisfaction in choice as a function of the number of alternatives: when 'goods satiate' 26 psychol. & marketing 197-203 (2009) (gift boxes); cassie mogilner et al., the mere categorization effect: how the presence of categories increases choosers' perceptions of assortment variety and outcome satisfaction, 35 j. consumer res. 202-15 (2008) (coffee). 34 e. osnos, choking on choices; as options explode, consumers cry, 'less!, chi. tribune, sept. 7, 1997), http://articles.chicagotribune.com/1997-09-07/business/ 9 7 09070121-1 products-choices-mutual-funds, archived at http://perma.cc/s6hktdl9. 35 sheena s. iyengar et al., how much choice is too much?: contributions to 401(k) retirement plans, in pension design and structure: new lessons from behavioral finance 83-95 (olivia s. mitchell & stephen p. utkus eds., 2004). vol. 11:2624 out-of-pocket healthcare spending why might a proliferation of options decrease choice quality and satisfaction? several explanations have been proposed that are not mutually exclusive. 36 the first is that as the number of options increases, it becomes more time consuming (and ultimately cognitively impossible) to exhaustively compare all the option attributes. a person must instead rely on simple heuristics, such as a satisficing rule. 37 although efficient, such heuristics can lead to systematic biases and, thus, relatively suboptimal choice quality. moreover, choosers may suffer anxiety because they realize the complexity of the choice has made it impossible to choose optimally.38 a second reason is that an increased choice set might introduce multiple attractive options, which are so similar that deciding in favor of one rather than another becomes more difficult. 39 finally, counterfactual thinking and regret are more likely because a larger choice set is more likely to have an attractive second-best, non-chosen alternative. from this perspective, outsourcing the rationing decision-and thus limiting choice-can actually provide benefits, namely, avoiding the disutility associated with choice overload. indeed, the choice overload problem is potentially even greater in the domain of health (relative to consumer choices about jams and chocolates), since decision difficulty is typically compounded by the need to understand scientifically complex treatments, often with substantial uncertainty as to likely outcomes. thus, whereas it might 36 see generally benjamin scheibehenne et al., can there ever be too many options? a meta-analytic review of choice overload, 37 j. consum. res. 409-425, 411 (2010). 37 gerd gigerenzer & wolfgang gaissmaier, heuristic decision making, 62 annu. rev. psychol. 451-482, 456 (2011) ("with the satisficing heuristic, the decision maker searches through options in any order, stops as soon the first option exceeds an aspiration level, and chooses this option"). 38 e.g., sheena s. lyengar et al., doing better but feeling worse looking for the "best" job undermines satisfaction, 17 psychol. sci. 143 (2006). 39 e.g., barbara fasolo et al., escaping the tyranny of choice: when fewer attributes make choice easier, 7 marketing theory 13 (2007). 2014 625 indiana health law review take thirty jams to overload a consumer choice about basic food preferences, even a handful of medical treatment options might quickly exert a similar overload.40 it is worth emphasizing that the disutility emerges in two ways, namely, decision quality and decision satisfaction. regarding quality, a patient overwhelmed with the choice might turn to a simplifying heuristic, such as just reflexively declining care or blindly deferring to her physician, who may suffer from biases of her own, including conflicting interests. 41 this can result in a different-and potentially worst-decision than if a fuller consideration were given. although there is no direct evidence about patient decision making on this point, a study of physicians by redelmeier and shafir reveals the underlying psychological phenomenon. 42 physician-subjects were asked to consider an elderly patient with osteoarthritis, who will soon visit an orthopedic surgeon for possible hip replacement but in the meantime had to stop taking several attempted nonsteroidal, anti-inflammatory medications due to inefficacy or adverse effects. the decision was whether to prescribe a new medication or forgo it until the orthopedic consult. half of subjects were told the remaining options were ibuprofen and piroxicam, while the other half were told only ibuprofen had yet to be tried. in line with a choice overload effect, 72% of subjects prescribed a drug when only ibuprofen was available, but they were less likely to prescribe a drug when both ibuprofen and piroxicam were 40 in other words, it is not the number of options per se that induces choice overload but, rather, the complexity of the choice, which is sensitive to features other than number per se. 41 katie beaver et al., decision-making role preferences and information needs: a comparison of colorectal cancer and breast cancer, 2 health expectations 266 (1999) (showing evidence of such deference); christopher robertson et al., effect of financial relationships on the behaviors of health care professionals: a review of the evidence, 40 j.l. med. & ethics 452, 458 (2012) (showing evidence of such conflicting interests having an impact on physician decisions). 42 donald a. redelmeier & eldar shafir, medical decision making in situations that offer multiple alternatives, 273 jama 302 (1995). vol. 11:2626 out-of-pocket healthcare spending available. 43 , as the authors interpreted the finding, "[alpparently, the uncertainty in deciding between two similar medications led some physicians to avoid this decision altogether and recommend not starting any new medication."44 b. depletion of cognitive capacity the second alternative to cost sharing holds constant the number of choices available to the patient but eliminates the price criterion for evaluation. 45 the costcriterion can create disutility, even aside from choice overload, because of the way that it enhances the complexity of the patient's decision. our rationality is "bounded," as herbert simon explains: bounded rationality is simply the idea that the choices people make are determined not only by some consistent overall goal and the properties of the external world, but also by the knowledge that decision makers do and don't have of the world, their ability or inability to evoke that knowledge when it is relevant, to work out the consequences of their actions, to conjure up possible courses of action, to cope with uncertainty (including uncertainty deriving from the possible responses of other actors), and to adjudicate among their many competing wants. rationality is bounded because these abilities are severely limited.46 people cope with the barrage of complexity by adopting cognitive heuristics or otherwise reducing their full 43 id. at 304. 44 id. at 304. 45 see supra part f ("forgo rationing"). 46 simon a. herbert, bounded rationality in social science: today and tomorrow, 1 mind & soc'y 25, 25 (2000). 2014 627 indiana health law review consideration of the decision problem. 4 7 because only a subset of information is considered, systematic biases can emerge. our cognitive capacity is not a static feature. the same complex decision can become more difficult-and biases more likely to emerge-as the decision maker becomes distracted, fatigued, overwhelmed with stress, and so forth.4 8 this is particularly relevant in the medical decision making context, where life and limb often hang in the balance and the decision maker is often making decisions in suboptimal circumstances. more specifically, the very consideration of financial constraints can induce suboptimal decision-making. recent research by mani et al. is revealing on this point. 49 in one experiment, shoppers at a new jersey mall made a series of hypothetical, financial-based decisions. one scenario, for example, stated, "your car is having some trouble and requires $x to be fixed. you can pay in full, take a loan, or take a chance and forego the service at the moment. . . . how would you go about making this decision?" 5 0 the amount ($x) was determined by random assignment. subjects were assigned to one of two conditions: a "hard" condition, wherein high costs were implicated (e.g., the car would take $1,500 to fix), or an "easy" condition involving lower costs (e.g., the car would only take $150 to fix). subjects then completed two tests of cognitive function, and reported demographic information, including wealth.5' the 47 see generally daniel kahneman, thinking, fast and slow (reprint 2013) (2011); thomas gilovich et al., heuristics and biases: the psychology of intuitive judgment (2002). 48 see generally sendhil mullainathan & eldar shafir, scarcity: why having too little means so much (2013). 49 anandi mani et al., poverty impedes cognitive function, 341 science 976 (2013). 50 id. at 976. 51 id. at 977 ("raven's test is a common component in iq tests and is used to measure 'fluid intelligence,' the capacity to think logically and solve problems in novel situations, independent of acquired knowledge. the spatial incompatibility task requires participants to respond quickly and often contrary to their initial impulse.") (internal citations omitted). vol. 11:2628 out-of-pocket healthcare spending central finding was an interaction effect of task difficulty and the respondent's wealth on cognitive performance. in particular, "poor" and "rich" subjects performed equally well on the cognitive tests following easy decisions; after hard decisions that evoked onerous financial situations, in contrast, the poor subjects performed substantially worse.52 as the authors interpreted it, "[p]reoccupation with pressing budgetary concerns leaves fewer cognitive resources available to guide choice and action."53 three additional experiments replicated mani's finding, as well as ruled out alternative explanations, such as math anxiety, a lack of real-world financial incentive, or that the cognitive tests themselves induced undue cognitive load. it also confirmed the effect size was substantial.54 the effect is akin to what sleep researchers observe after a subject suffers a full night of sleep deprivation; the performance difference between chronic alcoholics and normal adults; or a thirteen-point decrease in iq. 55 in other words, consideration of stressful financial constraints can seriously undermine cognitive performance. the authors warn that "policy-makers should beware of imposing cognitive taxes on the poor just as they avoid monetary taxes on the poor."56 accordingly, the imposition of cost sharing may actually reduce the patient's ability to think carefully about the other attributes of her healthcare choices. a different thread of research has focused, not on financially induced mental constraints, but more generally on the effects of depleted mental resources. fatigue, for instance, can seriously undermine the ability to think critically, even about important life decisions. consider the willingness of judges to grant a parole request. this requires an active decision, in the sense that greater mental effort is required to justify an exception to the default rule of maintaining the a priori sentence. one field study of israeli judges found that the proportions of parole grants 52 id. 53 id. at 976. 54 cohen's d ranged from 0.88 to 0.94. id. at 977. 55 id. at 980. 56 id. at 980. 2014 629 indiana health law review was tightly coupled with number of hours since the judge last took a break.57 as the time lengthened-and thus the judge became more fatigued-it became significantly less likely that the parole request would be granted. as soon as a break occurred, the proportion of parole grants returned to the same rate seen at the beginning of the morning. these threads of research are suggestive for the understanding the cognitive effects of cost-sharing burdens in healthcare. consideration of financial costs has the potential to undermine a fuller consideration of the nonfinancial choice features, such as likelihood of outcomes and quality of life. this is not to suggest that mental effort should not be spent on considering the financial constraints. rather the question is who: whether the patient, or someone else should be making this exertion. cost sharing may not be the most efficient allocation of effort. patients sense this difficulty: research has shown that u.s. health consumers are equivocal about the idea of discussing costs with physicians "in the clinical encounter."58 in focus groups conducted by sommers and colleagues, one respondent explained that when costs are introduced into the doctor-patient conversation, her reaction is to say, "i don't care! just fix my problem."5 9 another said, "all that's all well and good until you actually find yourself in a life-or-death situation, and you'll really see you're not even going to be concerned about the cost."6 0 patient may rationally prefer to ignore this factor, and, thus, rationally prefer a healthcare system that either outsources those considerations (at the sacrifice of options) or mutes them altogether (at the sacrifice of wealth). 57 shai danziger et al., extraneous factors in judicial decisions, proc. nat'l acad. sci. u.s. am. 6889, 6889 (2011). 58 roseanna sommers et al., focus groups highlight that many patients object to clinicians' focusing on costs, 32 health aff. (millwood) 338 (2013). 59 id. at 343. 60 id. 630 vol. 11:2 out-of-pocket healthcare spending c. facilitation of regret the facilitation of regret may be another way in which cost sharing causes subjective disutility. richard thaler has argued that, similarly to tourists preferring a resort that includes food and drink in the cost, health insurance buyers "choose not to choose" by sinking the costs of healthcare, so that at the point of consumption, they need not make choices about money in ways that they may later potentially regret. 61 a similar dynamic applies to health consumption: consider a couple which must decide whether to spend $x for a diagnostic test for their child. there is some small probability p that the child has a serious disease which could be treated if detected early enough. there will surely be regret if the decision is made not to get the test and the child later is found to have the disease. if the disease can be fatal, then the regret may loom so large that the test will be administered even for very large values of x or very small values of p. yet once the test is ordered and the likely negative result is obtained, the couple may regret the expenditure, especially if it is large relative to their income. obviously, these costs are avoided if all health care is prepaid, via either first dollar coverage or a prepaid health organization. 62 thaler goes on, however, to explain that this regret dynamic is not peculiar to out-of-pocket spending, but arises whenever there is a difficult decision. when there are two different surgical procedures from which to choose, "[chlearly in this situation a rational consumer would want the physician to make the choice and furthermore, he would not 61 richard thaler, toward a positive theory of consumer choice. 1 j. econ. behav. & org. 39, 53 (1980). 62 id. 2014 631 indiana health law review want to know that a choice existed!"63 that way, patients that suffer a bad outcome need not experience any regret. on this analysis, then, cost sharing is not itself problematic; rather, it is the difficulty of the decision that is problematic. still, the elimination of cost sharing by removing options or option attributes has the potential to avoid regret. terry connolly and colleagues, through a series of careful laboratory experiments, have delineated several different types of regret.64 noting that regret is a transitive verb-one typically regrets something-there is a distinction based upon the target of regret. with outcome regret the target is the outcome of the decision, whereas option regret focuses on the particular decision made, and process regret targets the way in which the decision was made, including the factors considered, information gathered, and time consumed. consider a patient who foregoes implantation of a surgical stent and then, months later, suffers a heart attack. the patient might experience regret: that the heart attacked occurred (outcome regret); that she chose stent over drugs (option regret); that he or she did not more carefully consider the pros and cons of implanting the stent (process regret); or any combination of these. the key difference is that process regret, unlike outcome regret, is "centrally concerned with mechanisms of self-criticism and justification."65 more particularly, when a poor decision outcome occurs, "individuals tend to ask themselves whether the decision, or the process that led up to it, was justified; if it was partially or entirely unjustified, we feel regret, the intensity of which is increased by the seriousness of the outcome." 66 these dynamics have only begun to be studied in the healthcare context, and we have found no research has 6 3 id. 64 terry connolly & jochen reb, regret aversion in reason -based choice, 73 theory decis. 35 (2012) (reviewing studies). 65 terry connolly & marcel zeelenberg, regret in decision making, 11 current directions psychol. sci. 212, s31 (2002). 66 id. 632 vol. 11:2 out-of-pocket healthcare spending focused on cost sharing in particular.67 we do know that regret is a common phenomenon in healthcare, however.68 as connoly and reb review the literature, "regret about treatment decisions was associated with worse current health related quality of life in men with localized prostate cancer and with worse generic and prostate-cancer-related quality of life and emotional well-being in men treated for metastatic prostate cancer, although the causal direction of the relations found in these studies remains uncertain."6 9 of course, in healthcare, there will always be bad outcomes, with or without cost sharing. plausibly, though, when a self-rationing cost-sharing scheme is replaced by an other-rationing scheme, a patient can be shielded from process regret, even while suffering bad outcomes. process regret is shielded, if the decision is outsourced to somehow else. if a treatment is declined, a patient might regret any ensuing bad outcome, but he or she will not be in a position of feel the pang of self-blame that is process regret. 70 if the other-rationer also prevents the patient from becoming aware of other options, she may also thereby avoid option regret. 71 cost sharing thus arguably increases these psychic costs. 67 see terry connolly & jochen reb, regret in cancer-related decisions, 24 health psychol. s29 (2005) (outlining directions for future research). 68 see e.g., e. p. winer, et al. silicone controversy: a survey of women with breast cancer and silicone implants, 85 j. nat'l cancer institute, 85, 1407-11 (1993) (showing that 34% of those who had received silicon implants would now be completely unlikely to choose them, while only 16% reported regrets about the reconstruction). 69 connolly & reb, supra note 64, at s32 (internal citations omitted). 70 see stacey l. sheridan, shared decision making about screening and chemoprevention, 26 am. j. preventive med., 56, 60 (2004) (discussing "fear of regret for decisions that turn out badly" as one reason patients do not seek to be involved in decision making). 71 see marco boeria et al., the role of regret minimisation in lifestyle choices affecting the risk of coronary heart disease, 32 j. health econ. 253, 253 (2013) (providing data from a discrete choice experiment, which support the conception of regret as "defined as what one experiences when a non-chosen alternative in a choice set performs better than a chosen one"). 2014 633 indiana health law review v. conclusions we have distinguished between several normative objections to the trend of asking patients to take responsibility for a portion of the costs of their healthcar and mined the potential problem that cost sharing may impose a "decisional burden." we identified the appropriate counterfactuals for thinking about the causal effects of cost sharing along this dimension and reviewed three potential mechanisms of disutility: choice overload, depletion of cognitive capacity, and facilitation of regret. we conclude that the decisional burden of cost sharing is a real problem. nonetheless, the behavioral science results are descriptive, not prescriptive. and we are unable to compare the size of this disutility with the diminishment of choices that comes with outsourcing the rationing function or the runaway costs that come with simply foregoing the rationing function altogether. this difficulty may explain why different political communities reach different conclusions about these ultimate questions. advocates of cost sharing must pay closer attention to these disadvantages of this particular mechanism for rationing healthcare. indeed, perhaps sustained attention will yield ways to improve the mechanisms of cost sharing so as to reap its advantages while minimizing some of these psychic costs. regardless, in a world of epistemic uncertainty and heterogeneity of values, it is not irrational for consumers to prefer cost sharing-if carefully designed and implemented-as the least-bad rationing mechanism among the alternatives, which either reduce access to healthcare or sink costs for unwanted healthcare. there may be a tradeoff here between autonomy and utility. george bernard shaw famously said that, "liberty means responsibility. that's why most men dread it." ultimately, the burden of deciding for yourself is the burden of being an autonomous person. 634 vol. 11:2 indiana iieaith law review volume9 2012 issue 2 aals symposium articles: teaching health law outside the classroom introduction beyond extemships: health law co-ops collaborating with the real world: opportunities for developing skills and values in law teaching a collaborative center in medicine and law: lessons from a disruptive innovation miami's medical-legal partnership: preparing lawyers and physicians for holistic practice jennifer s. bard wendy e. parmet charity scott marshall b. kapp jonel newman teaching health law in rural ethiopia: using a pepfar partnership framework and india's shanbaug decision to shape a course sallie thieme sanford putting theory into practice: thoughts from the trenches on developing a doctrinally integrated semester-in-practice program in health law and policy michele mekel the health justice project: a collaborative commitment to solving real world problems emily a. benfer legal methods for medical professionals year 2: shifting negative attitudes christine nero coughlin teaching holistic justice: medical-legal partnerships in the clinical setting dea c. lott law in action: learning health law through experience with stakeholders at the patient and system levels ' kathleen g noonan & sarah davis global health initiatives and health system development: the historic quest for positive synergies peter j. hammer & charla m. burill notes revising assisted outpatient treatment statutes in indiana: providing mental health treatment for those in need katherine b. cook protecting dr. smith while treating the chronic pain of mrs. jones: why the indiana medical licensing board should pass guidelines for using controlled substances for pain treatment macon jones ipads, iphones, androids, and smartphones: fda regulation of mobile phone applications as medical devices alex krouse robert h. mckinney school of law indiana university indianapolis indiana health law review volume9 editor-in-chief cow1ney campbell executive ma111lging editor joel swider executive production editors kate cook alexander berger executive business editor brienne delaney note development editors erin albert, mba, articles editors kyle fairchild macon jones kate shelby 2011-2012 executive notes editor lesley brown executive articles editor andrew breck executive symposium editor lance worland associate editors leeann pels beth pirro ash lee talley pharrnd ashley brian kyle johnson alex krouse chris serak ellen winternheimer gunnar crowell j.b. curry cora davidson brock easton james emerson daniel hageman julia hudson james inman alyssa james members faculty 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indiana university robert h. mckinney school of law 2011-2012 administrative officers and faculty administrative ofticen michael a. mcrobbffi, president of the university. ph.d., australian national university. charles r. bantz, chancellor, indiana university-purdue university-indianapolis. b.a., m.a., university of minnesota; ph.d., ohio state university. gary r. roberts, dean and gerald l. bepko professor of law. b.a., bradley university; j.d., stanford university. paul n. cox, vice dean and centennial professor of law. b.s., utah state university; j.d., university of utah college of law; ll.m., university of virginia school of law. james p. nehf,associate dean for graduate studies, cleon h. foust fellow, and professor of law. b.a., knox college; j.d., university ofnorth carolina law school. johnny d. pryor. assistant dean for student affairs. b.a., wittenberg university; j.d., indiana university maurer school oflaw. jonna kane macdougall, assistant dean for external affairs and 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university of illinois. deborah mcgregor, clinical professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law center. emil ymorris,associate professoroflawanddean 's fellow. a.b., harvard university; j.d., university of michigan law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. david orentucher, samuel r. rosen professor of law and co-director of the williams. and christine s. hall center for law and health. b.a., brandeis university; j.d., m.d., harvard university. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school of law. antony page, professor of law and dean's fellow; director, central & eastern european law summer program. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kathleen patchel, associate professor of law. a.b., huntington college; j.d., university ofnorth carolina law school; ll.m., yale law school. michael j. pitts, associate professor of law; dean's fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. peter a. prescott, associate professor of law. b.a., augustana college; m.s., the university of chicago; m.p.a., the university of texas at austin; j.d., the university of houston law center. fran quigley, clinical professor of law, health and human rights clinic, indiana university robert h. mckinney school of law; senior advisor, indiana university center for global health. b.a., hanover college; m.a., indiana university; j.d., indiana university robert h. mckinney school of law. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. ruiitenberg, clinical professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university robert h. mckinney school of law. joel m. schumm, clinical professor of law. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university robert h. mckinney school of law. lahny r. silva, associate professor of law. b.a., m.a., boston university; j.d., university of connecticut school of law; ll.m., university of wisconsin law school. margaret c. tarkington, associate professor of law. b.a., brigham young university; j.d., j. reuben clark law school, brigham young university. carltonmark.waterhouse,associateprofessoroflaw; dean's fellow. b.s., pennsylvania state university; j.d. with honors, howard university school oflaw; m. t.s., emory university, chandler school of theology; ph.d. with honors, emory university. frances watson, clinical professor of law. b.s., ball state university; j.d., indiana university robert h. mckinney school of law. lwyd t. wilson, jr., professor of law; director, joint center for asian law studies; director, chinese law summer program; director, american law for foreign lawyers ll.m program. b.a., wabash college; m.a., duke university; j.d., indiana university manrer school of law. r. george wright, lawrence a. jegen iii professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university robert h. mckinney school of law. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., universityofnebraska; ll.m., new york university school of law. edward p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, ill, professor of law emeritus. a.b., j.d., m.al.s., the university of michigan. clyde harrison crocketi, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. f alender, professor of law emerita. a.b., mount holyoke college; j.d., indiana university robert h. mckinney school of law. david a. funk, professor of law emeritus. a.b., college of wooster; j.d., case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.sj., northwestern university; j.d., university of colorado school of law. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of law emeritus. a.b., juniata college; j.d., george washington university law school. wjujam f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. wjujam hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. wjujam andrew kerr, professor of law emeritus. a.b., j.d., west virginia university; b.d., duke university; ll.m., harvard law school. eleanor dearman kinney, hall render professor of law, co-director of the williams. and christine s. hall center for law and health emerita. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. wjujam e. marsh, professor of law emeritus. b.s., j.d., university of nebraska. susanahm. mead, professor of law emerita. b.a., smith college; j.d., indiana university robert h. mckinney school of law. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., university oflllinois college oflaw. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james w. torke, carl m gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick widte, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. lawrence p. wilkins, william r. neale professor of law emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., universityoftexas school of law. mary therese wou:, clinical professor of law emerita. b.a., saint xavier college; j.d., university oflowa college oflaw. ruth lilly law library faculty juorrnfordanspach, professoroflawanddirector, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. debra densla w, reference librarian. b.a., franklin college; m.s., university of dlinois, urbana-champaign; j.d., valparaiso school of law. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a., georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, cataloging and government documents librarian. a.b., taylor university; m.l.s., indiana university. catherine lemmer, head of information services. b.a., lawrence university; j.d., university ofwisconsin; m.s., university oflllinois. chris e. long, cataloging librarian. b.a., indiana university; m.a., indiana university; m.l.s., indiana university. stbvenr..mn.ler.reference librorian. b.s., lebanon valleycollegeofpennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh, serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. mukphy, associate director. b.a, purdue university; j.d., m.l.s., indiana university-bloomington. klyoshi otsu,automated services and media librarian. aa, parkland college; a.b., m.s., c.as., university oflllinois. indiana health law review volume9 2012 issue 2 table of contents aals symposium articles: teaching health law outside the classroom introduction ................................................................................... jennifer s. bard 389 beyond externships: health law co-ops .................................... went{v e. parmet 399 collaborating with the real world: opportunities for developing skills and values in law teaching .................................................................... charity scott 409 a collaborative center in medicine and law: lessons from a disruptive innovation ................................................................................... marshall b. kapp 455 miami's medical-legal partnership: preparing lawyers and physicians for holistic practice ........................................................................................... jonel newman 471 teaching health law in rural ethiopia: using a pepfar partnership framework and india's shanbaug decision to shape a course .............. sallie thieme sanford 485 putting theory into practice: thoughts from the trenches on developing a doctrinally integrated semester-in-practice program in health law and policy ............................................................................................... michele mekel 503 the health justice project: a collaborative commitment to solving real world problems ............................................................................. emily a. benfer 521 legal methods for medical professionals year 2: shifting negative attitudes .......................................................................... christine nero coughlin 533 teaching holistic justice: medical-legal partnerships in the clinical setting ................................................................................................... dea c. lott 541 law in action: learning health law through experience with stakeholders at the patient and system levels ............................. kathleen g. noonan & sarah davis 551 global health initiatives and health system development: the historic quest for positive synergies ........................................ peter j. hammer & charla m buri/1 561 notes revising assisted outpatient treatment statutes in indiana: providing mental health treatment for those in need ......................................... katherine b. cook 661 protecting dr. smith while treating the chronic pain of mrs. jones: why the indiana medical licensing board should pass guidelines for using controlled substances for pain treatment. ........................................ macon jones 695 ipads, iphones, androids, and smartphones: fda regulation of mobile phone applications as medical devices ......................................................... a/ex krouse 731 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine shawna benston* i. introduction ................................................................... 1 ii. subjectivity of the mature minor doctrine criteria ............................................................... 3 iii. the mature minor doctrine “at work” .................... 8 iv. conclusion ................................................................. 14 i. introduction the frequently intersecting notions of autonomy and capacity are often seen as divergent in cases of medical decision-making by children. the legal system grants autonomy to make medical decisions to those over the age of 18 and denies it to those under the age of 18, due to an ostensible lack of “maturity” in the latter population sufficient to the legal authority to make such medical decisions. for those under the age of 18, their parents or legal guardians are called upon to formally dictate the direction of medical treatment; meanwhile, doctors and hospitals disagreeing with such parents’ instructions can opt to bring the dispute to court. thus, a child who might otherwise be able to engage, communicate, and participate in * b.a., yale university, j.d., benjamin n. cardozo school of law, m.b.e., university of pennsylvania, postdoctoral fellow in the ethical, legal and social implications (elsi) of genetics, columbia university. this article was first presented at the yale interdisciplinary center for bioethics 2015 summer symposium. the author would like to express sincere gratitude to steven j. errante, esq., for offering helpful suggestions. http://dx.doi.org/10.18060/3911.0011 2 indiana health law review vol. 13:1 his medical decision-making might see his medical wishes overridden by others’ potentially paternalistic choices. however, the mature minor doctrine offers the chance— in jurisdictions that recognize it—for minors to be deemed capable of making their own medical decisions. in order for minors to achieve this goal, they must satisfy various criteria predetermined by their respective states’ common-law determinations. having first emerged in the 1960s, notably in smith v. seibly,1 which in turn quoted from grannum v. berard, 2 the mature minor doctrine allows for some flexibility in a court’s determination of who can influence and even guide the medical experience of the minor. however, the doctrine merely allows a recognizing court to consider whether a minor can be deemed mature. furthermore, because of variations in jurisdictions’ criteria for what constitutes “maturity” and the intrinsic subjectivity (as discussed below) of the criteria, rulings on mature minor petitions are minimally predictable. therefore, the mature minor doctrine can lend predictability of process, as well as procedural justice, for minors wishing to challenge their medical teams’ decisions, but the doctrine cannot guarantee predictability of outcome of such challenges. 1 in smith v. seibly, 431 p.2d 719, (wash. 1967), plaintiff argued that a medical procedure to which he consented at age 18—when the age of maturity in his state was, at the time, 21—was an assault and battery because true consent had not been given. the court found in favor of defendant doctor, stating that the “[a]ppellant was married, independent of parental control and financial support and it was for the jury to decide if he was sufficiently intelligent, educated and knowledgeable to make a legally binding decision.” 2 in grannum v. berard, 422 p.2d 812, 815 (wash. 1967), plaintiff claimed that his doctor committed common law battery by performing a procedure to which plaintiff had consented as a minor. the court found for defendant doctor. according to the court, [i]n view of this record and the complete absence of medical testimony as to the plaintiff's claimed mental incapacity, we do not believe there is room for reasonable minds to differ that the plaintiff has failed to overcome by clear, cogent and convincing evidence the presumption that he comprehended the nature, terms and effect of the consent given for the surgical operation. 2016 3 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine this article explores the mature minor doctrine and how it has emerged in recent cases. it also discusses minors’ generally limited autonomy and calls for those in the medical and legal professions to seriously contemplate what can be done to protect minors suffering from unwanted medical treatments—especially those that render life more painful and uncomfortable than happy and satisfying. ii. subjectivity of the mature minor doctrine criteria at common law, minors are deemed incompetent to give consent or refuse medical intervention. it is therefore up to the individual states whether to evaluate a case under the mature minor doctrine, which considers legally relevant the desires, and consent or refusal, of minors who “exhibit[] the ‘maturity’ of an adult to make decisions that traditionally have been reserved for persons who have attained the age of majority.”3 because “‘maturity’ is not a well-defined legal term,”4 states that elect to conduct a mature minor doctrine analysis have determined sets of criteria that allow for casespecific determinations of a minor’s maturity, or lack thereof. generally, as law professor walter wadlington has summarized, “the cases in which the rule has been applied have had the following factors in common”5: (1) the treatment was undertaken for the benefit of the minor rather than a third party. (2) the particular minor was near majority (or at least in the range of 15 years of age upward) and was considered to have sufficient mental capacity to understand fully the nature and importance of the medical steps proposed. 3 jessica a. penkower, the potential right of chronically ill adolescents to refuse life-saving medical treatment fatal misuse of the mature minor doctrine, 45 depaul l. rev. 1165, 1166 (1996). 4 id. at 1167. 5 id. at 1179. 4 indiana health law review vol. 13:1 (3) the [risks of] medical procedures could be characterized by the court as less than ‘major’ or ‘serious.’6 the first factor necessarily specifies that any course of treatment or recommendation in question must be of potential benefit to the patient (patient-centered) and not primarily for the benefit of another party. in belcher v. charleston area medical center, the supreme court of west virginia exemplified how the second factor might be fully analyzed, explaining that whether a minor has sufficient capacity to consent to or refuse medical treatment depends upon: [the] age, ability, experience, education, training, and degree of maturity or judgment obtained by the child, as well as upon the conduct and demeanor of the child at the time of the procedure or treatment . . . [and] whether the minor has the capacity to appreciate the nature, risks, and consequences of the medical procedure to be performed, or the treatment to be administered or withheld.7 thus, for a proper analysis under the mature minor doctrine, the court must conduct an intensive investigation into who the minor is, what his life experiences have been prior to the hearing, and whether the minor has exhibited a sufficiently deep and thorough comprehension of his circumstances and treatment risks and benefits. this type of tailored personal analysis lies in stark contrast to courts’ medically inflected investigation of legal adults, who are presumed competent. the only potential roadblock to adults’ medical decision-making authority—or 6 id. at 1179-80 (drawing from walter wadlington, minors and health care: the age of consent, 11 osgood hall l. j. 115, 119 (1973)). 7 belcher v. charleston area med. ctr., 422 s.e.2d 827, 838 (w.va. 1992). 2016 5 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine medical autonomy—is a collection of four countervailing state interests: “(1) the preservation of life, (2) the protection of innocent third parties, (3) the prevention of suicide, and (4) the maintenance of the ethical integrity of the medical profession.”8 while adults can consent to medical treatment with extremely rare controversy 9 , the refusal of treatment— especially when such refusal is guaranteed, or even just likely, to result in death—may come under scrutiny by institutional committees or governmental agencies, or may even be condemned in the court of public opinion. most controversial, of course, is the decision by an adult to hasten death by means of physician-assisted suicide. the case of bouvia v. superior court epitomizes the difficulty that adults may encounter by seeking to remove or refuse life-saving medical intervention, or even hydration and nutrition. 10 in this case the patient in question, elizabeth bouvia, was mentally competent but physically suffering from cerebral palsy, in anguish to the point of attempting suicide by means of self-starvation. after hospital staff forcibly inserted a nasogastric tube to keep her alive, bouvia sought a preliminary injunction from the california trial court that would require the tube's removal and prohibit similar measures. after the trial court denied her preliminary injunction, she sought relief in the court of appeals of california. citing the proclamation from the council on ethical and judicial affairs of the american medical association that “[a]t all times, the dignity of the patient should be maintained,” 11 the court of appeals granted bouvia the right to determine whether she would welcome or shun medical intervention.12 ultimately, bouvia 8 penkower, supra note 3, at 1171. 9 a controversial treatment election might be extreme plastic surgery, for example. 10 bouvia v. superior court, 179 cal. app 3d 1127 (1986). 11 id. at 1141 (quoting the council on ethical and judicial affairs of the american medical association, withholding or withdrawing life prolonging medical treatment (mar. 15, 1986)). 12 id. 6 indiana health law review vol. 13:1 chose not to die by means of self-starvation, citing side effects of her morphine regimen that made starvation unbearable.13 notably, the bouvia court included discussion of two issues crucial to the exploration of the mature minor doctrine: (1) “[w]ho shall say what the minimum amount of available life must be?”14 and (2) how can we reconcile the doctrine of double effect and the state’s concern for preservation of life? the first issue is intrinsically philosophical and ostensibly rhetorical. but it should be answered quite simply with “no one.” realistically, no one can say when another person has lived long enough— whether that other person is aged fifteen or ninety-five. in the bouvia case, judge beach illustrated a prioritization of quality over quantity: does it matter if it be 15 to 20 years, 15 to 20 months, or 15 to 20 days, if such life has been physically destroyed and its quality, dignity and purpose gone? as in all matters lines must be drawn at some point, somewhere, but that decision must ultimately belong to the one whose life is in issue. . . . it is not a medical decision for [the patient’s] physicians to make. 13 see jerry menikoff, law and bioethics: an introduction 262 (georgetown university press, 2001). during a 60 minutes segment broadcast on september 7, 1997, the following dialogue took place: mike wallace: (voiceover) ‘after several attempt[s] at starvation, elizabeth told us, it just became physically too difficult to do. she didn’t want to die a slow, agonizing death, nor to do it in the spotlight of public scrutiny. and she told us, with great regret, she quietly chose to live.’ ms. bouvia: ‘starvation is not an easy way to go.’ wallace: ‘oh, no.’ ms. bouvia: ‘you can’t just keep doing it and keep doing it. it really messes up your body. and my body was already messed up.’ see also beverly beyette, the reluctant survivor: 9 years after helping her fight for the right to die, elizabeth bouvia’s lawyer and confidante killed himself—leaving her shaken and living the life she dreaded, la times (sept. 27, 1992), http://articles.latimes.com/1992-0913/news/vw-1154_1_elizabeth-bouvia [http://perma.cc/mtj2-5qzz]. 14 bouvia, 179 cal. app 3d 1127 at 1143. 2016 7 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine neither is it a legal question whose soundness is to be resolved by lawyers or judges. it is not a conditional right subject to approval by ethics committees or courts of law. it is a moral and philosophical decision that, being a competent adult, is [the patient’s] alone.15 of course, the bouvia court was examining an issue of adult competence to make medical decisions; what remains to be explored is whether a capacitated minor can be granted the same freedom to determine for himself how much life devoid of “quality, dignity and purpose” is enough. the doctrine of double effect “is often invoked to explain the permissibility of an action that causes a serious harm, such as the death of a human being, as a side effect of promoting some good end.”16 specifically, the doctrine of double effect states that “if doing something morally good has a morally bad side effect,” it is ethical to do it as long as the bad side effect was not intended—and even if the bad effect was foreseen as probable.17 the principle is used to justify a doctor’s giving drugs to a terminally ill patient to relieve distressing symptoms even though he knows that doing so may shorten the patient's life. an analysis under this doctrine must examine the “fundamental legal principles of causation and intent”18 in its determination that a patient’s refusal of medical intervention, or consent to aggressive palliative care, results in death from the underlying disease or pathology—not from the withholding of medical care or application of palliative care.19 15 id. 16 alison mcintyre, doctrine of double effect, stanford encyclopedia of philosophy (sept. 13, 2014),http://plato.stanford.edu/ entries/double-effect/ [http://perma.cc/b3wu-zy8t]. 17 see, e.g., ethics guide: the doctrine of double effect, bbc, http://www.bbc.co.uk/ethics/euthanasia/overview/doubleeffect.shtml [http://perma.cc/h2zd-5szt] (last visited oct. 2, 2015). 18 vacco v. quill, 521 u.s. 793, 801 (1997). 19 id. at 801-02 (quoting assisted suicide in the united states, hearing before the subcommittee on the constitution of the house committee on the judiciary, 104th cong. 2d sess., 367 (1996)). 8 indiana health law review vol. 13:1 such an arguably passive death notably differs from an active death achieved by assisted suicide. it is this distinction between “letting die” and “killing” that underlies many of the arguments against assisted suicide; 20 for purposes of this article, it should be understood as a point of clarity for informed consent cases involving adults: while a competent adult cannot, in most states, legally consent to assisted suicide measures to hasten death, generally (thanks to cases like bouvia), he can refuse life-saving medical intervention, even if it results in his death. this article asks: can mature minors be granted the same sort of autonomy by means of a mature-minor-doctrine analysis, and, if so, why aren’t more states conducting mature-minor-doctrine analyses? iii. the mature minor doctrine “at work” to illustrate a court’s investigative process under the mature minor doctrine, we turn now to cassandra c., a 17year-old connecticut patient with hodgkin’s lymphoma, whose case provides what might have been deemed an easy one for an application of the mature minor doctrine, even while a mature-minor determination proved impossible. 21 since her diagnosis in september 2014, cassandra has asserted her desire not to receive chemotherapy as treatment for her cancer, even though patients with her diagnosis are considered by the oncologic community to have an 80% chance of long-term survival with early treatment. 22 condemning the chemotherapy as “poison,” cassandra has apparently believed for many years prior to her diagnosis 20 shawna benston, balancing autonomy and beneficence: the legal, sociopolitical, and philosophical history of and support for legalizing assisted suicide, 24 nysba elder & special needs l. j., 22, 22-28 (2014). 21 in re cassandra c., 316 conn. 476 (2015). 22 samantha masunaga, “connecticut teen fighting state justices’ ruling on forced chemotherapy”, l. a. times (jan. 10, 2015, 8:53 pm), available at http://www.latimes.com/nation/la-na-teen-chemo-20150111story.html [https://perma.cc/b9m8-g44v]. 2016 9 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine that such treatment would be intolerable to her—in other words, her antipathy was not casually or swiftly determined.23 furthermore, not only was cassandra less than a year away from legal maturity at the time of her case, but her mother fully agreed with and supported her desire to abstain from chemotherapy, despite the potentially dire consequences.24 however, after cassandra and her mother missed some of her medical appointments, “her physicians made a report of possible medical neglect to the petitioner, department of children and families (‘dcf’),” 25 which in turn filed a petition for and won an order of temporary custody.26 a sixmonth regimen of chemotherapy was begun. soon thereafter, the supreme court of connecticut affirmed that the state could force a minor to undergo chemotherapy.27 so, had that court conducted an analysis under the mature minor doctrine? yes and no: the supreme court of connecticut stated in its opinion that “because the evidence does not support a finding that cassandra was a mature minor under any standard, this is not a proper case in which to decide whether to adopt the mature minor doctrine.”28 however, certainly it is at least a bit nonsensical to say that a doctrine is not being adopted because the case at hand does not satisfy it. in effect, the court did conduct a matureminor-doctrine analysis, finding that cassandra did not satisfy the criteria. thus, cassandra’s case constitutes the first in which the connecticut supreme court considered the mature minor doctrine, setting a precedent that justifiably dismays cassandra. indeed, as the american civil liberties union of connecticut reminded the court in its amicus brief, 23 id. at 492. 24 id. 25 joint brief of respondent mother and minor child with separate index at 1-2, in re cassandra c., 316 conn. 476 (2015). 26 in re cassandra c., 316 conn. 476, 486 (2015). 27 id. at 500. 28 id. at 481. 10 indiana health law review vol. 13:1 prior to the court’s decision texas had been the only state to reject the mature minor doctrine, while six other states and washington, d.c. “have held or suggested that mature minors, like other competent people, have the right to consent to or forego medical treatment.29 the court, however, found persuasive the argument of dcf’s counsel, assistant state attorney general john tucker, that cassandra and her mother had engaged in ‘“magical thinking’ that ‘[i]f i closed my eyes to the fact i have this serious illness, then my cancer doesn’t exist.’”30 tucker further asserted that “[r]eally, it was the mother who was taking the front seat on this. the child was overshadowed by the mother’s negative feelings about chemotherapy.” 31 however, cassandra herself defended her mother in an oped, stating, “in no way is my mom neglectful. she has always put me before herself. i am offended by anyone who believes otherwise. my mom has been identified as ‘hostile,’ ‘neglectful’ and ‘unsupportive,’ three untrue words that break my heart.”32 furthermore, cassandra’s op-ed expressed her firm understanding that her desired abstention from chemotherapy was driven by her own feelings and beliefs 29 christiane cordero, state supreme court rules teen canate supreme cou., nbc connecticut (jan. 8, 2015, 12:12 pm), http://www.nbcconnecticut.com/troubleshooters/state-supreme-courthears-arguments-in-teen-chemotherapy-case-cassandra-connecticut287933331.html [http://perma.cc/twe7-f7b3]. these six states are “illinois, maine, tennessee, west virginia, michigan, and massachusetts.” 30 josh kovner, connecticut supreme court upholds ruling that state can force chemotherapy on teen, hartford courant, (jan. 8, 2015, 9:14 pm), http://www.courant.com/news/connecticut/hc-teenbattles-chemo-order-0103-20150102-story.html#page=1 [http://perma.cc/ 4hql-4b3j]. 31 id. 32 cassandra c., op-ed. cassandra’s chemo fight: ‘this is my life and my body’, hartford courant, (jan. 8, 2015), http://www.courant.com/opinion/op-ed/hc-op-cassandra-my-body-my-life0109-20150108-story.html?dssreturn&z=10003 [http://perma.cc/dl6v6jdh]. 2016 11 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine about what would be right for her. her fear and frustration are unequivocal: this experience has been a continuous nightmare. i want the right to make my medical decisions. it’s disgusting that i'm fighting for a right that i and anyone in my situation should already have. this is my life and my body, not dcf’s and not the state’s. i am a human—i should be able to decide if i do or don’t want chemotherapy. whether i live 17 years or 100 years should not be anyone's choice but mine. how long is a person actually supposed to live, and why? who determines that? i care about the quality of my life, not just the quantity.33 bouvia is loudly echoed in this statement, which certainly exhibits the level of maturity required for a judge’s ruling that the speaker should be permitted to make her own medical decisions. and yet, cassandra was forced to continue being injected with what she deemed “poison.”34 what went wrong? in the supreme court of connecticut’s ruling, it appears that the finding that cassandra was not a mature minor was based on her having either intentionally misrepresented her intentions to the trial court or . . . changed her mind on this issue of life and death [and that] [i]n either case, her conduct amply supports judge quinn’s finding that the respondents 33 id. 34 sarah larimer, connecticut’s highest court approves forced chemotherapy for teen, the washington post (jan. 8, 2015), http://www.washingtonpost.com/news/morningmix/wp/2015/01/08/ connecticuts-highest-court-approves-forced-chemotherapy-for-teen/ [http://perma.cc/6rrj-3syl]. 12 indiana health law review vol. 13:1 [cassandra and her mother] have failed to prove that cassandra was a mature minor under any standard.35 the court essentially found it more reprehensible that cassandra had temporarily run away, in order to avoid being medicated against her will, than that she had been “strapped to a bed by [her] wrists and ankles and sedated”36 and might be again. because the court found issue with cassandra’s potentially having changed her mind, it can be inferred that in order to make medical decisions, one must never change one’s mind. so, should elizabeth bouvia have been retroactively found incompetent after she chose to keep on living? of course, the answer should be “no.” the law does not say that in order to be one’s own medical decision-maker, one must be bound to the first opinion or decision one makes, but that in order to make legally valid medical decisions, one must be able to provide competent and informed consent or refusal of medical care. it is common knowledge that throughout a course of treatment—especially for an ongoing and potentially dire condition—a patient might change direction, especially as new or changed information becomes available. it would be unethical to force a patient to stick with his first opinion or decision, in a contract-like arrangement; by extension, it should be unethical to do the same to a minor who would otherwise be deemed mature. and yet, cassandra was effectively punished for her having even just potentially changed her mind about life’s perhaps most confusing issue: what constitutes a life worth living? it is worth asking whether the judge’s ruling would have been different had cassandra presented a religious basis for her wish to withdraw and withhold medical intervention. the critical mature-minor-doctrine case, in re e.g., found a minor the same age as cassandra—seventeen—competent to refuse a blood transfusion as part of treatment for leukemia. 35 order at 2, in re cassandra c., 112 a.3d 158 (conn. 2015) (no. 19426), available at http://www.scribd.com/doc/252076272/cassandra [https://perma.cc/a3wc-2zwm]. 36 cassandra c., supra note 32. 2016 13 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine the basis for this competence was that “acceptance of blood would violate personal religious convictions rooted in [e.g.’s] membership in the jehovah’s witness faith.”37 although the court did not base its decision on religious grounds, the religious conviction of the minor is what garnered her sufficient recognition to allow for the court’s mature-minor analysis. specifically, the court compared the e.g. case to two previous cases 38 that involved jehovah’s witnesses, allowing for consideration39 of e.g.’s case despite its having been rendered moot due to e.g.’s having reached the age of majority. although e.g. and her mother provided a constitutional basis—the first amendment’s free exercise clause—for the refusal of the blood transfusion, the judge declined to consider it, saying that “a mature minor may exercise a common law right to consent to or refuse medical care.”40 the judge thereby strengthened the mature minor doctrine by finding it sufficient in itself, without constitutional support, to allow a mature minor to refuse life-saving treatment. indeed, the e.g. court did not wish to find or make an extension of the constitutional right of abortion, which naturally is granted to minors because “[c]onstitutional rights do not mature and come into being magically only when one attains the state-defined age of majority.”41 thus, it was a rather strange case: while religious reasoning, built on a free exercise clause foundation, helped convince the judge of e.g.’s maturity (in other words, it got e.g.’s foot in the door), a constitutional analysis was found irrelevant. a pivotal statement made in the opinion — “[w]e see no reason 37 in re e.g., 549 n.e.2d 322, 323 (ill. 1989). 38 the two cases were in re estate of brooks, 205 n.e 2d 435 (ill. 1965) and people ex rel. wallace v. labrenz, 104 n.e. 2d. 769 (ill. 1952). 39 the court found a public interest exception to mootness because of the frequency of cases involving jehovah’s witnesses members who refused to consent to blood transfusions. in re e.g., 549 n.e.2d 322 at 325. 40 in re e.g., 549 n.e.2d 322 at 328. 41 id. at 326, quoting planned parenthood v. danforth, 428 u.s. 52, 74 (1976). 14 indiana health law review vol. 13:1 why this right of dominion over one’s own person should not extend to mature minors”42 — highlights the importance of the finding of maturity, while underscoring that once a minor is found mature, control over his person should be treated as a right. if proof of a minor’s maturity is his religious conviction — if a minor’s religious conviction is considered proof that the minor should be taken seriously — what hope do irreligious minors have of proving themselves competent to make their own medical decisions? while one commentator has found that “[t]he disparity among jurisdictions in their use of the [mature minor] doctrine, the inherent vagueness of the concept of maturity, and the complexity of the medical and legal matters involved in treatment refusal cases effectively undermine the doctrine’s efficacy,” 43 it seems that such vagueness could work as easily for minors as against them. just as not all adults are competent to make their own medical decisions, so, too, are not all minors lacking in the maturity required to do so. there should not be—and, in practice, is not — a bright line dividing adults and minors that, on the former side, includes all competent individuals and, on the latter side, includes all incompetent individuals. a more nuanced analysis is required on a case-by-case basis to determine an individual’s medical-decision-making competence, regardless of that individual’s age. iv. conclusion when are young people old enough to make potentially life or death decisions? we allow 17-year-olds to enlist in the army. teens as young as 15 are regularly tried as adults in murder cases. so why shouldn’t a 17-year-old have the right to decide what medical treatments she will undergo?44 42 id. at 326. 43 penkower, supra note 3, at 1191. 44 w.w., cassandra’s catch-22, the economist (jan. 14, 2015, 2:57 pm), http://www.economist.com/blogs/democracyinamerica/2015/01/ medical-consent [http://perma.cc/97bg-grnk]. 2016 15 not of minor consequence?: medical decision-making autonomy and the mature minor doctrine we can easily see divergences in how the law and society view and treat minors, and such divergences have had a notable impact on minors’ ability to make their own medical decisions. indeed, perhaps it is this lack of predictability that particularly harms minors and even their parents, who might — as in cassandra’s case45 — support their children’s desire to withhold or withdraw medical intervention. however, the solution is not to insert predictability by drawing a bright line at age 18 for purposes of bodily autonomy. instead, the mature minor doctrine should be employed to make an informed, nuanced analysis of each case. parental accord with children’s wishes should only strengthen a case for finding a minor mature, instead of being ignored simply because such accord does not comport with the medical team’s recommendations. states that employ the mature minor doctrine do right to weigh the state interests of “(1) preserving life; (2) protecting third parties; (3) preventing suicide; and (4) maintaining the ethical integrity of the medical profession” against “the strength of the minor’s right to refuse treatment.”46 allowing for a caseby-case analysis is appropriate, considering that no individual—and no minor individual—is the same as any other; one person’s medical experiences and personal traits are not necessarily replicated in another’s. indeed, perhaps the solution lies outside the courtroom setting and should be determined as part of the doctorpatient interaction and with as much concern for a minor’s informed consent as for that of an adult patient. or, should this discussion remain in the courtroom, perhaps a shift of the burden of proof is in order: a minor in his mid-teens should be presumed competent unless proven otherwise. 45 id. (“as it happens, cassandra's mother, jackie fortin, supports her daughter's decision to forgo chemotherapy treatments. is cassandra's middle-aged mother too immature to make decisions on her daughter's behalf? presumably not. so what gives?”) while the connecticut supreme court ultimately found cassandra’s mother neglectful, certainly such a finding would not in itself override a finding that a minor is sufficiently mature to justify recognition of her own medical decision-making capacity. 46 penkower, supra note 3, at 1187 (citing in re e.g., 549 n.e.2d 322, 328 (ill. 1989)). 16 indiana health law review vol. 13:1 ultimately, it must be determined what, exactly, “mature” means, both literally and legally. who determines when another person has become “mature”? what role does, and should, age play in determining someone’s “maturity”? how can our legal system grapple with such nebulous terminology? finally, how can physicians work within the legal system while upholding their oath to do no harm? as we continue wrestling with such questions, courts would do well to employ the mature minor doctrine in order to lend predictability of process to cases of minors’ bodily autonomy, while preserving the states’ interests. in this way, analysis using the mature minor doctrine would allow courts to protect immature minors from potentially detrimental medical decisions, which they lack the capacity to make, while honoring mature minors’ informed and competent medical decision-making capacity. such analysis would also provide procedural justice for minors, even if the result is not in their favor.47 it is not the age of 18 that should signify maturity and the competence to manage one’s own medical treatment, but rather the confluence of emotional maturation, sufficient experience and education, and developed judgment and demeanor at the time of the potential treatment that must be analyzed to determine a minor’s capacity to refuse unwanted medical intervention. the legal system, if it is to adequately protect minors, must consider the minor's potential to make well-informed medical decisions. 47 nancy welsh, making deals in court-connected mediation: what’s justice got to do with it? 79 wash. u. l.q. 787, 820 (2001). julie c. klish ms. klish is an associate specializing in health care and food and drug regula­ tion with the law firm of hyman, phelps & mcnamara, p.c. in washington, dc. in 2004, ms. klish graduated from the university of north carolina school oflaw, where she was a member of the north carolina law review. she received a bachelor of arts from purdue university (with highest dis­ tinction, honors, and phi beta kappa, 2001 ). ms. klish is a member of the american bar association and the food and drug law institute. in the fall of 2004, her article on group purchasing organizations won second place in the food and drug law institute's h. thomas austem writing competition. she is admitted to practice law in north carolina and is pending admission to the district of columbia bar. serving economic efficiencies or anticompetitive purposes? the future of group purchasing organizations and the antitrust safety zone julie c. klish* "gaining a gpo contract is essential for any medical equipment supplier. gpos determine which medical devices will be used to treat us when we are sick or injured, which manufacturers will survive and prosper, and-which ones will fail. "1 introduction while price competition is at the heart of the medical device industry, so too is competition for innovation and product quality. after all, the medical device industry deals primarily in life-saving mechanisms. however, the presence of small research and development companies, which focus pri­ marily on developing better, innovative devices, may be on the decline today due to joint purchasing arrangements used by the group purchasing industry. this article will analyze the antitrust safety zone for group purchasing organi­ zations ("gpos") and whether this safety zone has become a safe harbor for monopolists. putting the safety zone aside, this article will identify how current contracting practices utilized in joint purchasing arrangements would constitute antitrust law violations outside of the group purchasing, health care context. after considering the practical effect of current gpo contracting practices on small medical device manufacturers, this article critically examines the government's decision to maintain the status quo of the antitrust safety zone. * ms. klish is an associate at the law firm of hyman, phelps & mcnamara, p.c. in washington, dc (b.a, purdue university, 2001; j.d., university ofnorth carolina, 2004). the views expressed in this article are the views of the author and do not necessarily represent the views of hyman, phelps & mcnamara, p.c. or any of its clients. she would like to thank steven d. tibbets for his encouragement to publish this article and her family and friends for their support. 1. hospital group purchasing: lowering costs at the expense of patient health and medica/innovation?, before sen. judiciarycomm. subcomm. on antitrust, competition &bus. & consumer rights, 107th cong. (2002) {statement of sen. herbert kohl, subcomm. chair­ man), available at http://judiciary.senate.gov/member_statementcfm?id=236&wit_id=470. 174 indiana health law review [vol. 2:171 i. background: gpos and current contracting practices with approximately 6,900 hospitals nationwidel annually spending an estimated $190 billion on supplies/ gpos intermediate this billion dollar industry by negotiating contracts with hospitals and manufacturers alike. in 2000, a government-commissioned study showed that "72 percent of all hospital purchases are made via a gpo-negotiated contract. •>4 for a company that manufactures medical devices, contracting with a gpo is a marketing department's dream. some of the largest gpos manage several hundred member hospitals that each desire to purchase the best medical devices for the cheapest price. 5 gpos, though intermediaries, wield great power in this posi­ tion. gpos are created through an alliance among health care organizations to aggregate their buying power in order to achieve "advantages of scale.'m the member health care organizations of the gpo are its owners or affiliates, much like the corporate model. the owners typically hold shares or equitable interests while the affiliates possess only a contractual relationship with the gpo. 7 all of these entities comprise the membership of a gpo. by negotiat­ ing supply contracts for their health care provider members, gpos help hospitals "eliminate duplicative transaction costs" that each would incur by individually negotiating supply contracts. 8 gpos are sophisticated entities that gather information about the latest medical products and finance their 2. u.s. gen.accounting0mce, ga0-03-998t, group purchasingorganjzations: use of contracfing processes and strategies to award contracfs for medic.alr surgery products 5 (2003) [hereinafter ga0-03-998t]. 3. senate retains grip on gpos, healthcare purchasing news online, nov. 2003, at http://www.hpnonline.com/inside/nov031ll 03gpos.htm (last visited apr. 16, 2005) (on file with the indiana health law review). 4. group purchasing organizations: fed. trade comm. and dep't of justice joint hearings on health care and competition law and policy, at 6 (september 26, 2003) (statement of robert betz, ph.d., president and ceo of health industry purchasing group association (higpa)) (referencing a march 2000 study conducted by muse & associates), available at http://www.ftc.gov/os/commentslhealthcarecomments2/higpa.pd.f. 5. ga0-03-998t, supra note 2, at 4. 6. premier, mdshareonline: news for physicians and healthcare executives fre­ quently asked questions, at http://www.premierinc.com//alllmdshare/mdshareonline_faqs/ f aq-indexpage-md.shareonline.jsp (last visited apr. 16, 2005) (on file with indiana health law review). premier is the second largest gpo with an estimated 1,800 members. u.s. gen. accounting office, ga0-02-690t, group purchasing organizations: pn.ot sruny suggests large buying groups do not always offer hospitals lower prices 20 (2002) [hereinafter ga0-02-690t]. 7. ga0-02-690t, supra note 6, at 5-7; see premier, about premier: fast facts, at http://www.premierinc.com/alllaboutpremier/overview/fast-tacts.jsp (last visited apr. 16, 2005) (on file with the indiana health law review). 8. thomas h. brock, hospitals, graup purchasing organizations, and the antitrust laws, healthcare fin. mgmt., mar. 2003, at http://www.findarticles.com/cf dls/m3257/ 3_57/98953926/printjhtml (last visited apr. 16, 2005) (on file with the indiana-health law review). 2005] the future of group purchasing organizations 175 own independent tests of new products, which are functions that, practically speaking, "no one provider could finance or conduct'>9 for example, novation, the largest of the gpos with an estimated 2,300 members, was formed in 1998 after two alliances consolidated their supply­ contracting areas.10 novation facilitates roughly $23 billion in annual pur­ chases by its members. 11 while novation is the largest gpo, the government estimates that there are several hundred gpos, though seven of these gpos "account for more than 85 percent of all hospital purchases nationwide made through gpo contracts."12 membership in a gpo is voluntary to the extent that a health care provider can afford the expense of directly contracting for its supplies with individual manufacturers and distributors. there are several different mem­ bership arrangements that gpos can have with their members. for those health care providers who join a gpo, some gpos, such as health trust, pro­ hibit membership in other gpos.13 in addition, gpos often require that their members purchase all of their supplies or a percentage of their supplies through gpo negotiated contracts. 14 overall, gpos vary widely in the mem­ bership requirements and restrictions that they impose. the main function ofgpos is to negotiate contracts with manufacturers and distributors of supplies that their health provider members need in order to operate. the agreements that gpos negotiate with suppliers utilize various contracting mechanisms, which include the signing of product bundling, sole­ source, long-term, and requirements contracts each of which charges admini­ strative fees to manufacturers. the general accounting office (gao) dis­ cussed each of these in its july 16, 2003 report to the senate subcommittee on antitrust, competition policy and consumer rights.15 after a brief descrip­ tion of each contracting practice, the remainder of this article will center on an analysis of whether these contracting practices would violate the federal antitrust laws if used outside the group purchasing arena. 16 9. /d. 10. novation, about novation: overview, at http://www.novationco.com/about/ default.asp (last visited apr. 16, 2005) (on file with the indiana health law review). 11. ld. 12. ga0-03-998t, supra note 2, at 4. the majority of gpos are regional or local; however, the majority holders of purchasing volume are the seven national gpos. the seven largest gpos in descending order are: novation, premier, amerinet, health trust, insource, consorta, broadlane, and hppi. ga0-02-690t, supra note 6, at 20-22. 13. ga0-02-690t, supra note 6, at 6. 14. ga0-03-998t, supra note 2, at 12-13. 15. /d. at 10-14. 16. 15 u.s.c. §§ 1, 2, 14 (2005). 176 indiana health law review [vol. 2:171 ll. contracting practices product bundling refers to the practice of grouping together multiple products and selling them to gpo members as a package deal. gpos use these bundling arrangements in three varieties: bundling "complementary pro­ ducts,"17 bundling ''unrelated products"18 from a single manufacturer, and requirements bundling19 from different manufacturers.20 the appeal ofbundl­ ing from the customer's perspective is a discounted price for items purchased in a bundle rather than separately through the gpo. the appeal of bundling from the manufacturers' perspective is an increased likelihood that their products will be purchased, which justifies the price reduction on their end. the practice of sole-sourcing is used by gpos when they contract with only one manufacturer to supply that type of device or product to their members, thereby establishing an exclusive dealing contract with that manu­ facturer. customers of the gpo are then given one choice for obtaining that medical device or product through the gpo. for gpos that require members to purchase all of their supplies from those manufacturers with whom the gpo has negotiated contracts, this contracting mechanism guarantees sales for the manufacturer who is awarded a sole-source contract. gpos also sign long-term contracts with medical device manufacturers and commitment agreements with gpo members. after evaluating the seven largest gpos, the gao reported that the ''two largest gpos typically awarded 5-year contracts, whereas the other five gpos typically awarded 3-year con­ tracts. "21 these agreements ensure the likelihood of future sales for manufac­ turers and reduce the frequency in which gpos have to renegotiate contracts with manufacturers. commitment agreements, on the other hand, require gpo customers to buy a certain amount or percentage of their supplies from manu­ facturers who have contracted with the gpo. the commitment levels assist gpos in negotiating contracts with manufacturers, because the manufacturers are more willing to offer a discounted price where commitment levels ensure sales. finally, gpos charge each manufacturer administrative fees based on the total purchases that members of the gpo make from the manufacturer. a provision of the social security act permits gpos to charge and receive administrative fees as an exception to the anti-kickback rules. 22 a department 17. ga0-03-998t, supra note 2, at 6 (providing an example of protective hats and shoe coverings as complementary products). 18. the gao refers to this type ofbundling as a "corporate agreement." id at 13. 19. the gao refers to this type ofbundling as a "structured commitment program." id. this type ofbundling groups products from different manufacturers together to form a package deal and additionally requires customers to agree to purchase a set percentage of their total requirements from the bundle. 20. id 21. id at 14. 22. 42 u.s.c § 1320a-7b(bx3}(c) (2005}. 2005] the future of group purchasing organizations 177 of health and human services regulation strengthens the social security act's writing requirement on administrative fees by requiring gpos to limit fees to a maximum of 3% of the purchases made under the contract or to stipulate some other amount up front. 23 the use of disjunctive language in this regulation allows gpos to name their price so long as manufacturers agree to pay the fees set by the gpo. the gao reported that the highest fee charged by the gpos that it studied was around 18%.24 over the last few years, this array of contracting practices has undergone the scrutiny of the u.s. senate, department of justice ("doj"), and federal trade commission ("ftc"). gpos represent the buyers in the health care industry and try to negotiate the best deal for those buyers. on the other hand, most gpos are for-profit entities with operation costs and have an interest in negotiating contracts that will minimize their costs (and maximize their profits). in their role as intermediaries, there is no question that gpos have administratively made the hospital supply contracting process more efficient.25 but are the contracting practices that gpos use assisting a handful of manu­ facturers in monopolizing product markets within the medical device industry under the guise of efficiency? ill. the protection of the safety zone in 1993, the doj and ftc first issued an antitrust enforcement policy for joint purchasing organizations that was later revised in 1996. that policy, as it reads today, creates a safety zone from antitrust enforcement for gpos that satisfy a two-part test. in other words, the safety zone exempts gpos from antitrust enforcement, provided that they can meet the requirements of the test. the doj and ftc have said that they ''will not challenge, 'absent extraordinary circumstances, any joint purchasing arrangement among health care providers" that satisfies the two-part test. 26 the first hurdle established by the two-part test requires a gpo to show that ''the purchases account for less than 35 percent of the total sales of the purchased product or service in the relevant market:m for example, this means that the total pacemaker purchases made by members of an individual gpo cannot exceed a percent threshold when compared to the total amount 23. 42 c.f.r. § 1001.952(j) (2005). 24. ga0-03-998t, supra note 2, at 10. 25. the cost-benefit analysis remains fuzzy, however, following the release of the gao report which suggested, based on a sampling of medical products studied, that large gpos are not producing savings for their member providers that are greater than what small gpos or providers individually have been able to negotiate. ga0-02-690t, supra note 6, at 3. 26. u.s. dep'tofjustice&fed. tradecomm., statement ofdepartment of justice and federal trade commission enforcement policy on joint purchasing a"angements among healthcare providers, in statements of anrrrrust enforcement poucy in healthcare 53, 54 (aug. 1996), available at http://www.ftc.gov/reports/hlth3s.pdf. 27. jd. at 54-55. 178 indiana health law review [vol. 2:171 of pacemakers being sold "in the relevant market."28 the market is defined two ways, by taking into consideration both a geographic market and a pro­ dqct market. the geographic market for medical devices is generally a national market while the product market can vary depending on the type of medical device. the product market for pacemakers may simply be all pace­ makers or it may be a sub-category of pacemakers. the second requirement is applicable only where some or all of the gpo's member providers are "direct competitors."29 to satisfy the second prong of the test, the gpo must show that ''the cost of the products and ser­ vices purchased jointly accounts for less than 20 percent of the total revenues from all products or services sold by each competing participant in the joint purchasing arrangement. "30 this means that the aggregated purchases made by the gpo's members cannot exceed 20% of the total profits made from all goods and services sold by each competing member provider. in 1994, thomas greaney, an antitrust scholar, explained the govern­ ment's reasoning behind this two-part test. he stated: the logic of this analysis is that unless the [gpo] ... repre­ sents a significant proportion of all buyers in the market, it probably cannot exercise monopsonypowerto drive prices of purchased goods or services below competitive levels. thus, any lower prices negotiated likely reflect efficiency benefits, such as economies ofscale.31 if providers' joint purchasing arrangements fall within the safety zone, then they are exempt from antitrust enforcement and the agencies will only chal­ lenge their arrangement in "extraordinary circumstances."32 however, this phrase has never been defined by the agencies, so it is an unknown standard. one major shortcoming of the joint purchasing safety zone is that it provides "no guidance for enforcement policy on exclusionary agreements that gpos might enter into with suppliers. •m the agencies do provide a list of three mitigating factors to consider for arrangements that fall outside the safety zone; however, these factors are not considered for arrangements that fall inside the safety zone. in their enforcement policy, the agencies state that "antitrust concern is lessened" where: (1) "members are not required to use 28. /d. at 55. 29. /d. 30. /d. 31. thomas l. greaney, a critique: the department of justice/ftc health care policy statements, 8 antitrust 20,22 {1994). 32. u.s. dep't of justice & fed. trade comm., supra note 26, at 54. 33. einer elhauge, antitrust analysis of gpo exclusionary agreements: comments regarding hearings on health care and competition law and policy-statement for doj-ftc hearing on gpos 1 (sept. 26, 2003), available at http://www.ftc.gov/os/comments/ healthcarecomments2/elhauge.pdf. 2005] the future of group purchasing organizations 179 the arrangement for all their purchases of a particular product or service," (2) an independent employee or agent conducts negotiations for the gpo, and (3) "communications between the purchasing group and each individual partici~ pant are kept confidential" from the other participants. 34 even where mitigating factors are not present, the agencies state that "[w]here there appear to be significant efficiencies from a joint purchasing arrangement, the agencies will not challenge the arrangement absent sub­ stantial risk of anti competitive effects."35 through the creation of this safety zone, the agencies are tolerating and thereby giving protection to anticom­ petitive practices used by gpos as long as the gpos can meet the require­ ments of the two-part test and not fall within the undefined "extraordinary circumstances" zone. if the safety zone is met, efficiency and competitive practices are presumed and are only questioned where a gpo cannot meet the requirements of the two-part test. n. confronting the antitrust laws putting the antitrust safety zone aside, this section examines whether the contracting practices used by gpos could survive restraint of trade, mono­ polization, and exclusive dealing claims brought under the federal antitrust laws. the would-be plaintiff for this analysis is a small medical device manu­ facturer, such as applied medical resources corporation (hereafter "applied medical"), that is suing a competitor manufacturer for its use of anticom­ petitive contracting practices. these anti competitive practices include product bundling or tying arrangements and exclusive dealing arrangements. said hilal, ceo of applied medical, testified in 2003 during the ftc/ doj hearings on gpos. applied medical is a corporation with five hundred employees that markets 250 devices used in ''cardiac and vascular surgery, general surgery, urology, colorectal surgery andobgyn surgery."36 while applied medical does not struggle with the innovation of new devices, it has encountered difficulty marketing its products. among the devices that applied medical markets are trocars, a basic instrument used to explore tissues. 37 in his testimony at the ftc/doj hearings on gpos, mr. hilal approximated that this is a $300 million market. 38 34. u.s. dep't of justice & fed. trade comm., supra note 26, at 56-57. 35. /d. at 57 (emphasis added). 36. applied medical, products, at http:/ !www.appliedmed.com/products/default.aspx (last visited apr. 16, 2005) (on file with the indiana health law review). 37. websters online dictionary, trocar, at http://www.websters-online­ dictionary.orglfr/trocar.html (last visited apr. 16, 2005) (on file with the indiana health law review). 38. joint ftcidoj hearings on healthcare and competition law and policy, before the fed. trade comm., at 142 (sept. 26, 2003) (statement of said hilal, chief executive officer, applied medical resources corporation), available at http://www.ftc.gov/ogc/ healthcarehearings/030926ftctrans.pdf. 180 indiana health law review [vol. 2:171 after approaching forty gpos to sell its trocars at a price 60% below the prices for which the gpos had contracted with applied medical's competi­ tors, none of the gpos offered applied medical contracts. 39 the reason that mr. hilal gives for this is that "[a] handful ofgpos can control80 percent of the demand channel, and .... [ o ]ne supplier can require 90 percent com­ pliance.'>40 when you imagine that this supplier has contracted, using a 90% compliance requirement, with the handful of gpos that mr. hilal refers to, then that means that this single supplier controls at least 72% of the market share for trocars.41 according to the united states court of appeals, eighth circuit, "[a ]n eighty percent market share is within the permissible range from which an inference of monopoly power can be drawn. "42 so, the 72% market equation, when played out in reality, would likely amount to a finding of monopoly power. could a plaintiff such as applied medical succeed on restraint of trade, monopoly, or exclusive dealing actions against its competitor manufacturers who have used tying arrangements and exclusive dealing provisions in their contracts? in other words, have courts found similar contracting practices used outside the group purchasing context to be in violation of the federal antitrust laws? in order to allege these claims, a plaintiff must first prove standing to bring such actions. a plaintiff has standing to sue in an antitrust lawsuit provided that the plaintiff manufacturer is able to allege harm and the court finds that this manufacturer, applied medical, is a proper plaintiff to bring the antitrust claims.43 39. id 40. id. at 143. mr. hilal refers to this arrangement as ''monopoly multiple." ld. 41. id 42. morgenstern v. wilson, 29 f.3d 1291, 1296 n.3 (8th cir. 1994). 43. associated gen. contractors of cal., inc. v. cal. state council of carpenters, 459 u.s. 519, 535 n.3l (1983). as commentators have observed, the focus of the doctrine of'antitrust standing' is somewhat different from that of standing as a constitutional doctrine. harm to the antitrust plaintiff is sufficient to satisfy the constitutional standing require­ ment of injury in fact, but the court must make a further determination whether the plaintiff is a proper party to bring a private antitrust action. ld (citing daniel berger & roger bernstein, an analytical framework for antitrust standing, 86 yale l.j. 809, 813 n.1l (1977)). 2005] the future of group purchasing organizations 181 a. tying arrangements tying arrangements come under the purview of the restraint of trade rules of the sherman act.44 the supreme court has said: [t]he essential characteristic of an invalid tying arrangement lies in the seller's exploitation of its control over the tying product to force the buyer into the purchase of a tied product that the buyer either did not want at all, or might have pre­ ferred to purchase elsewhere on different terms. when such "forcing" is present, competition on the merits for the tied item is restrained and the sherman act is violated. 45 under these conditions, tying arrangements are per se unreasonable restraints of trade. there are five elements that a plaintiff must show to prove the existence of an illegal tie-in arrangement. first, the plaintiff must show the existence of a tying product and a tied product.46 the tying product is the one whose sale is conditioned on the requirement that the buyer also purchase the tied product. second, the plaintiff must produce evidence of"actual coercion by the seller forcing the buyer to accept the tied product. "47 third, the plaintiff must show "sufficient economic power in the tying market to coerce" pur­ chasers to buy the tied product.48 fourth, the plaintiff must show "anticom­ petitive effects in the market for the tied product."49 finally, the plaintiff must show the tied product's involvement in a "not insubstantial" amount of interstate commerce. 50 where the plaintiff cannot show a per se violation, 44. 15 u.s.c. § 1 (2005). section 1 of the sherman act makes contracts in restraint of trade illegal. there are three elements that a plaintiff must show in order for a section 1 claim to succeed. first, the plaintiff must show that there has been a contract or conspiracy between two parties. second, the plaintiff must show that this contract or conspiracy "is in, or substantially affects, interstate commerce." medical supply chain, inc. v. us bancorp, na, no. civ. a.02-2539-cm, 2003 wl 21479192, at *2 (d. kan. june 16, 2003) (citations omitted). finally, the plaintiff must show that the contract ''unreasonably restrains trade" under either the per se approach or the rule of reason approach. jd. the basic difference between the two approaches lies in the extent to which a court must examine the actual effect on competition which an allegedly anti-competitive business practice has. ''under the rule of reason test, the court must determine the competitive impact of a particular practice in the context of a relevant market. under the per se rule, a court does not conduct this extensive inquiry, because the practice in question has been held to be manifestly anti-competitive." ortho diagnostic sys., inc. v. abbott labs., inc., 822 f. supp. 145, 157 (s.d.n.y. 1993). 45. jefferson parish hosp. dist. no.2 v. hyde, 466 u.s. 2, 12 (1984). 46. orthodiagnosticsys, inc., 822f. supp. at 157 (quotingsuburbanpropanev. proctor gas, inc., 953 f.2d 780,788 (2d cir. 1992)). 47. ld. 48. id 49. !d. 50. ld. 182 indiana health law review [vol. 2:171 courts will apply a rule of reason analysis, examining the particular facts to see if the general requirements for a section 1 claim under the sherman act are present. 51 in 2003, the gao reported that "most gpos used some form ofbundl­ ing, and the two largest gpos used either contracts or programs that bundled multiple products for a notable portion of their business."52 without the safety zone, a manufacturer like applied medical could succeed in a lawsuit against a competitor supplier who has entered into bundling agreements on the grounds that the bundling agreements are per se illegal tying, creating an unreasonable restraint on trade. because the manufacturers have direct clauses in their agreements with gpos to bundle products, it would be easy for applied medical to prove the first two elements of the tying claim and to show that the sale of trocars affects interstate commerce. there are only two elements that will present a challenge for applied medical. they would need to show that their competitor manufacturer has sufficient power in the tying market in order to coerce customers to purchase the competitor's trocars, which, as a result, has produced anticompetitive effects in the market for trocars. sufficient power in the tying market is "inferred from the seller's possession of a predominant share of the market. "53 determining whether applied medical will be able to succeed on this claim will depend on the tying market of their competitor manufacturers. if applied medical could demonstrate that a manufacturer held a 72% market share, which mr. hilal presented at the hearings, in the tying product, then this would likely satisfy the requirement of demonstrating power in the tying market. applied medical would be able to present the contracts for trocars that customers rejected in order to show anticompetitive effects in the tied, trocar market. there are many cases in the health care area involving tying arrangements, which suggest that the bundling arrangements that manufac­ turers use with gpos would be illegal outside the group purchasing context. in smithkline corporation v. eli lilly & company,54 the plaintiff, smithk.line, claimed that eli lilly used a pricing scheme that utilized rebates to tie together the purchase of two patented drugs with the purchase of an unpatented drug that eli lilly was marketing. 55 there was no express tying clause forced upon the purchasers; instead, the combination of the patents and rebate system left purchasers no other rational choice than to buy the tied drug. because of their patents in the tying market, eli lilly was in a position to exert coercion over the tied product's market. in this case, the third circuit ruled for the plaintiff on a monopolytheoryratherthan a tying theory, finding 51. see e.g., arizona v. maricopa county medical soc., 457 u.s. 332, 343-44 (1982). 52. ga0-03-998t, supra note 2, at 11. 53. eastman kodak co. v.lmage technical servs., inc., 504 u.s. 451,464 (1992) (citing jefferson parish hosp. dist. no.2 v. hyde, 466 u.s. 2, 17 (1984)). 54. smithkline corp. v. eli lilly & co., 575 f.2d 1056 (3d cir. 1978). 55. smithkline corp. v. eli lilly & co., 427 f. supp. 1089, 1091-92 (e.d. pa. 1976). 2005] the furore of group purchasing organizations 183 that eli lilly had willfully acquired and unlawfully maintained a monopoly. 56 if eli lilly did not have patents on the drugs to which they were tying, this case probably would have succeeded on a tying theory rather than a monopoly theory. in ortho diagnostic, a contract with the council of community blood centers (ccbc) was at issue. ortho diagnostic systems, inc. (hereinafter "ortho"), the plaintiff, brought this lawsuit against abbott laboratories, inc. for a preliminary injunction alleging an implied tying arrangement similar to the one·in smithk/ine.51 ccbc solicited proposals for five blood screening tests from both the plaintiff and the defendant in the case. blood donation centers rely on the use of these screening tests to make sure that the blood units that they collect are safe for transfusions. the contract with ccbc was a group purchasing agreement in which blood donation centers had the option of participating. 58 abbott won the contract, and ortho brought suit claiming that abbott's pricing scheme was aperse unreasonable restraint of trade. 59 abbott's hn and htl v60 tests were already popular on the market, so ortho claimed that abbott used a pricing scheme to force a buyer who wanted those two tests into purchasing the other three.61 the district court held that abbott's pricing scheme did not violate the sherman act and granted summary judgment to abbott on ortho' s claim of illegal tying with respect to the tests. 62 at trial, ortho lost their tying claim, because they failed to show that the pricing scheme used by abbott made purchasing all five tests from abbott the "only viable economic option. •o6j furthermore, the court found that "if the tying product may be purchased without also buying the allegedly tied pro­ duct, there can be no unlawful tying.'o64 it is worth pointing out that this case was decided when the safety zone for gpos was in place. the court did not pay any special attention to the fact that ccbc was negotiating a group pur­ chasing contract in this case. applying both of these cases to the bundling arrangements that gpos have admitted to using, it is clear that without the antitrust safety zone, the 56. smithkline corp., 515 f.2d at 1065. 57. ortho diagnostic sys., inc. v. abbott labs., inc., 822 f. supp. 145, 147 (s.d.n.y. 1993). in this case, there was not an explicit condition in the contract with ccbc that required buyers of the mv and htl v tests to purchase the other three tests from abbott. ld. the court highlighted case law that suggests that a tying arrangement can be "inferred from the pricing structure of two products and the market power which the party has." jd. at 157-58. 58. jd. at 148-49. 59. jd at 157. 60. this is a test used to detect a type ofleukemia. ld. at 147. 61. id at 157. 62. ortho diagnostic sys., inc. v. abbott labs., inc., 920 f. supp. 455, 477 (s.d.n.y. 1996). 63. id. at 471-72. 64. ld. at 471. 184 indiana health law review [vol. 2:171 parties to joint purchasing bundling arrangements would be violating the sherman act's provision against unreasonable restraints of trade. the manu­ facturers' contracts with the gpos directly force member providers to pur­ chase tied products or a high percentage of those tied products; thus, no inference of a tying arrangement is necessary. recently, a small medical device manufacturer, similar to applied medical, filed a case to challenge a tying arrangement that harmed its sales. in november of2003, conmed corporation, a medical device designer and manufacturer, filed a lawsuifi5 against johnson & johnson and some of its subsidiaries. the lawsuit alleges that johnson & johnson uses exclusive deal­ ing provisions and the illegal tying and bundling of sutures to high require­ ments agreements for the purchase of endoscopy products, which penalize hospitals that fail to meet the high requirement levels. 66 conmed asserts that "johnson & johnson furthered this anticompetitive conduct through its contracts and other dealings with group purchasing organizations, such as novation and premier.'o67 as a result, conmed claims that its sales of endo­ scopic surgical products have been hindered. furthermore, conmed argues that johnson & johnson's anticompetitive use of tying arrangements has pre­ vented hospitals from being able to purchase cheaper medical devices, such as those that conmed markets. 68 the claims raised by conmed are similar to the arguments that mr. hilal made at the ftc/doj hearings with regard to how applied medical marketed the same trocars as its competitors at a 60% price reduction and still was unable to secure contracts. however, it is interesting that conmed even mentions johnson & johnson's contracts with gpos in its complaint, since joint purchasing arrangements are generally free from antitrust enforcement through the safety zone. if this case goes forward and does not settle, then it will be interesting to see how the court treats conmed's claims, given that johnson & johnson enters into these arrangements with both gpos and individual hospitals. b. monopolization section 2 of the sherman act makes it a felony to monopolize or attempt to monopolize "any part of the trade or commerce among the several states.'o69 65. this lawsuit was filed in the southern district ofnew york. conmed corporation is headquartered in utica, new york.. 66. conmed files suit against johnson &johnson for violation of antitrust laws, pr newswire, nov. 10, 2003, at http://www.prnewswire.com/cgi­ bin/stories.pl? acct= 1 04&story =/www/story/11-1 0-2003/0002054256&eda te= (last visited apr. 16, 2005) (on file with the indiana health law review). 67. id 68. id 69. 15 u.s.c. § 2 (2005). 2005] the future of group purchasing organizations 185 "monopoly power is the power to control prices or to exclude competition."70 the claim of monopoly under section 2 has two elements. first, the plaintiff must show that the defendant possesses monopoly power in the relevant market. second, the plaintiff must show that the defendant has willfully acquired or maintained that power "as distinguished from growth or develop­ ment as a consequence of a superior product, business acumen, or historic accident. "71 a plaintiff must show the presence of four elements to succeed on an attempted monopolization claim. first, the plaintiff must define the relevant market, including the product and geographic markets. second, the plaintiff must show that there is a "dangerous probability of success in mono­ polizing the relevant market. "72 third, the plaintiff must prove that the defen­ dant had a specific intent to monopolize.73 finally, the plaintiff must show conduct in furtherance of an attempt to monopolize. 74 claims of monopolization have been more numerous before the courts than alleged tying arrangements (presumably because of the per se illegality of these). it is much easier to mask unlawfully rising to monopoly power or attempted monopolization than it is to mask a bundling or tying arrangement. a plaintiff, such as applied medical, would be able to argue the presence of sole-source and requirements contracts used by its competitor manufacturer in order to demonstrate how its competitor is attempting to obtain monopoly power or has already succeeded in holding monopoly power. the intent requirement for both actual monopolization and attempted monopolization will be an important factor for the courts. "unlike the offense of actual monopolization, which requires only a showing of the monopolist's intent to engage in anti competitive conduct, an allegation of attempt to mono­ polize cannot succeed unless the would-be monopolist is shown to have 'a specific intent to destroy competition or build monopoly. "'75 outside of the group purchasing context, the long-term, exclusionary agreements that device manufacturers enter into would seem to, by themselves, establish a specific intent to put their competitors out ofbusiness. however, malicious intent and vociferous threats to sell at higher prices are behavior "not condemned by sherman act section 2" unless these acts in some way contribute to the likeli­ hood that one party will secure a monopoly.76 70. barr labs., inc. v.abbottlabs.,978f.2d98, 111-12(3dcir.1992)(citingpa.dental ass'n v. medical serv. ass'n ofpa., 745 f.2d 248, 260 (3d cir. 1984)). 71. united states v. grinnell corp., 384 u.s. 563,570-71 (1966). 72. medical supply chain, inc. v. u.s. bancorp, na, no.civ.a 02-2539-cm, 2003 wl 21479192, at *5 (d. kan. june 16,2003)(quotingfulldrawprods. v. easton sports, inc., 182 f.3d 745, 756 (loth cir. 1999). 73. !d. 74. !d. 75. ashkanazy v. rokeach & sons, inc., 757 f.supp. 1527, 1535 (n.d. ill. 1991) (quoting times-picayune pub. co. v. united states, 345 u.s. 594,626 (1953)). 76. !d. at 1540. 186 indiana health law review [vol. 2:171 in order to succeed on a claim of actual monopolization, as compared with attempted monopolization, the courts primarily focus on the percentage of iruirket share held by the defendant. 77 in morganstern v. wilson, the court considers a monopoly challenge by a doctor against a professional corporation of doctors in the same region. 78 the doctor in that case presented insufficient evidence of the geographic and product markets; however, the court gave an important accounting of the level of market share that would have been suffi­ cient to prove the existence of monopoly power. 79 the court stated that 80% is enough, but that "a thirty percent market share will not prove the existence of monopoly power."80 the court also cited a case that said 60% is unlikely sufficient. 81 but what about the 72% market share that mr. hilal hypothesized a supplier in the market today easily could obtain with the help of gpo con­ tracts? it is unclear, without knowing specific factual circumstances, whether or not courts would generally find this percentage to meet the threshold of monopoly power. what action can a plaintiff like applied medical bring when there are two or three manufacturers that have independently bound over 90% of the market share in long-term, exclusionary agreements? under these facts, which probably are closer to reflecting market realities, those two or three competitor manufacturers would not be monopolists, unless they were acting together to monopolize the market, and applied medical would be left to struggle in a virtually closed market. 82 · the market for erythromycin in the barr laboratories case reflects this type of situation, where abbott laboratories controlled 500/o of the market, boots/upjohn controlled 17.67% of the market, and parke-davis controlled 13.68%.83 together, these three entities held a monopolist's share of the market with a combined 82.17% of the market. 84 according to the court, barr laboratories asserted that this was a "highly concentrated market. "85 how­ ever, the court concluded that abbott "did not have a reasonable probability of successfully monopolizing the adult oral erythromycin market.'.u for 77. in an attempted monopolization case, a manufacturer may hold as high as 500/o of the market share. if the manufacturer is not engaging in activities that tend to lead toward monopolization and thereby lacks the "dangerous probability of success" in attempting to monopolize, the amount of market share is of little relevance. barr labs., inc. v. abbott labs., 978 f.2d 98, 112 (3d cir. 1992). 78. morganstern v. wilson, 29 f.3d 1291, 1296 n.3 (8th cir. 1994). 79. id at 1297. 80. /d. at 1296 n.3. 81. id (citing domed stadium hotel, inc. v. holiday inns, inc., 732 f.2d 480, 489 (5th cir. 1984)). 82. however, an exclusive dealing claim might be available, which the next part of the article will consider. 83. barr labs., inc. v. abbott labs., 978 f.2d 98, 112 (3d cir. 1992). 84. /d. 85. id at 113. 86./d 2005] the future of group purchasing 0rganiza tions 187 gpos with these same levels of market share, the joint purchasing safety zone prevents the antitrust laws from reigning in manufacturers who actually mono­ polize, or attempt to monopolize, by securing gpo contracts. the safety zone gives manufacturers, the sellers, dangerous freedom in this regard. the ftc has been active in preventing monopolies from forming in the medical device area. in 2000, the ftc intervened in the proposed acquisition ofmallinckrodt inc. ("mallinckrodt") by tyco international ltd. ("tyco") in order to protect competition in the endotracheal tube market. 87 at the time of the proposed acquisition, tyco and mallinckrodt were the two largest sup­ pliers of endotracheal tubes, with mallinckrodt being the largest. 88 the ftc's consent decree required tyco to divest itself of a line of endotracheal tubes, because tyco's acquisition of mallinckrodt would give tyco a post­ acquisitionmarket share of86%.89 the ftc found this to be a monopolist's share that would allow the combined entity to "exercise market power unila­ terally, thereby increasing the likelihood that purchasers of endotracheal tubes would be forced to pay higher prices and that innovation and service levels in the market would decrease.'t90 because the medical device industry involves competition for life-saving devices, the fear ofhampering innovation is magni­ fied. even more important than ensuring a competitive marketplace for medical devices is ensuring a marketplace that permits innovators freely to enter the market. in march of 2003, the third circuit heard a case involving 3m, which conceded that it possessed monopoly power in the transparent tape market by holding a 90% market share.91 lepage's, the plaintiff in the case, argued that "3m willfully maintained its monopoly in the transparent tape market through exclusionary conduct, primarily by bundling its rebates and entering into con­ tracts that expressly or effectively required dealing virtually exclusively with 3m ... .''92 in lepage's, inc., the third circuit reviewed a jury finding that 3m violated section 2 of the sherman act to determine whether there were enough facts in the case to support the jury's finding.93 the third circuit upheld the jury determination that 3m violated section 2. 3m offered pur­ chasers "magnified rebates" for purchasing 3m's scotch tape in combination with its other product lines. 94 the rebates that 3m gave to lepage's customers were equal to almost half the amount of total sales that lepage's had made to those same customers.95 for example, lepage's 1993 sales to sam's club 87. tyco international, ltd.; analysis to aid public comment, 65 fed. reg. 63,253, 63,253-54 (oct. 23, 2000). 88. id at 63,253. 89. !d. at 63,253-54. 90. !d. at 63,253 (emphasis added). 91. lepage's, inc. v. 3m, 324 f.3d 141, 146 (3d cir. 2003). 92. !d. at 147. 93. !d. at 169. 94. id at 156. 95. !d. at 157. 188 indiana liealtii law review [vol. 2:171 totaled $1,078,484, ''while 3m's 1996 rebate to sam's club was $666,620.'>96 3m may not have willfully acquired power in the tape market, but these practices demonstrated willful maintenance of the monopoly power that they admitted to holding. applying the lepage's case to the group purchasing context and the exclusionary agreements that gpos enter into with manufacturers, 3m's rebate structure utilized the strategy of product bundling to get purchasers to buy tape from 3m rather than its competitors. giving buyers an incentive to purchase goods is not, by itself, a violation of the sherman act. but, here, 3m's actions to entice purchasers, while already holding a monopolist's share of the market, tipped the scales against them. the practice that 3m engaged in here is not unlike the exclusionary schemes that medical device manu­ facturers enter into with gpos. group purchasing contracts with long-term, sole-source, and high requirements provisions are designed to secure and maintain market share. there can be no procompetitive business justification for using these con­ tracting practices; binding market share for years to come and requiring that the purchaser not deal with any of the manufacturer's competitors can only be the actions of a want-to-be monopolist. while long-term, sole-source con­ tracts with manufacturers do create a streamlined contracting process for gpos, the efficiencies of utilizing this contracting scheme are far outweighed by the likelihood of resultant anticompetitive effects to market entrants and participants. administrative fees, discussed earlier in this paper, may also play a role in assisting manufacturers in moving towards protected monopolization in joint purchasing arrangements. in 2003, the gao said that six out of the seven largest gpos "reported that they have not negotiated any new or renewed contracts in 2003 that include administrative fees from medical­ surgical product manufacturers that exceed 3 percent. "97 the competition pro­ blem posed by the hhs regulation, which essentially allows gpos to name their price as long as manufacturers agree to it, is that small manufacturers with fewer financial resources could be priced out of the market if the cost of entry became unaffordable. in essence, the manufacturer with the greatest financial resources in a relevant market could pay excessive administrative fees to gpos in order to secure contracts with them, thereby buying monopoly power. c. exclusive dealing the final claim that a plaintiff manufacturer could bring, outside the group purchasing context, to challenge the contracting practices of competitor 96. /d. 97. ga0-03-998t, supra note 2, at 10; see supra note 23 for information about the 3% limit. 2005] the future of group purchasing organizations 189 manufacturers similar to those used by opos is a claim under section 3 of the clayton act98 this section of the clayton act makes illegal contracts for the sale of goods ''where the effect of such ... contract for sale ... may be to sub­ stantially lessen competition or tend to create a monopoly in any line of com .. merce."99 the supreme court has said that a plaintiff need not show that com­ petition actually has been lessened by the exclusive dealing arrangement.100 because some exclusive dealing clauses may serve a legitimate, procompeti­ tive business purpose, courts examine challenges to these vertical restraints under the rule of reason analysis. 101 the elements that a court will examine where there is an exclusive dealing arrangement are the following: the rele­ vant market, the amount of that market that the arrangement has foreclosed to competing manufacturers, and any procompetitive reasons to justify keeping the arrangement in place.102 in 1982 when group purchasing arrangements were on the rise, a district court in white and white v. american hospital supply corporation said that "[a] group prime vendor agreement which rises to the level of a group exclusive dealing arrangement would result in a substantial lessening of competition and a concomitant tendency towards monopolization in local distribution markets."103 the court went on to say that "a group purchasing agreement which suppresses competition in any local market where a member of the group is located violates the antitrust laws. to conclude otherwise is to permit group exclusive dealing contracts, which are not competitively bid, to establish local or regional monopolies."104 the dicta in this case is significant, because it demonstrates that as early as 1982 (before the antitrust safety zone was even created) there was a fear that group exclusive dealing agreements had the ability to suppress competi­ tion and produce monopolies. with the antitrust protection that the govern­ ment affords opos under the current safety zone, market realities are begin­ ning to reflect the district court's initial concern over exclusive dealing arrangements in white & white. this is the state of affairs alleged by applied medical, the would-be plaintiff in my analysis, and the trend toward mono­ polies examined in the previous section seems to support that supposition as well. exclusive-dealing, requirements, and long-term agreements that are 98. 15 u.s.c § 14 (2005). 99. id. (emphasis added). 100. standard oil co. of cal. v. united states, 337 u.s. 293, 311 (1949). 101. chuck's feed& seed co. v.ralstonpurinaco.,810f.2d 1289, 1294(4thcir.1987). 102. id at 1295. 103. white & white, inc. v. am. hosp. supply corp., 540 f. supp. 951, 1029 (w.d. mich. 1982). this statement is only dicta within the court's opinion and is not the holding of the case. the case was later reversed on the grounds that the district court did not properly define the geographic and product markets. in its reversing opinion, the sixth circuit court of appeals did not comment on the general legality of exclusive dealing agreements. white & white, inc. v. am. hosp. supply corp., 723 f.2d 495 (6th cir. 1983). 104. white & white, inc., 540 f. supp. at 1029. 190 indiana health law review [vol. 2:171 used industry-wide have all of the ingredients necessary for substantially lessening competition in the relevant market. a plaintiff, such as applied medical, will not have a difficult time defining the relevant market. the geographic market is generally a national one for medical devices and the product market varies depending on the level of sophistication of the medical device and the saturation of models in that market.105 the plaintiff will have a more difficult time showing whether the level of competition foreclosed by the exclusive dealing contracts constitutes a substantial share of the relevant market and rebutting the defendant's pro­ competitive justifications for utilizing exclusive dealing contracts. there are two tests that courts use for determining whether exclusive dealing contracts have foreclosed a substantial share of market competition. there is a quantitative test and a qualitative test that courts apply. the land­ mark case of standard oil co. v. united states106 laid the analytical founda­ tion for the quantitative substantiality test. in that case, standard oil entered into exclusive dealing contracts with retail service-stations that covered 16% ofthe petroleum product market in the western state region. 107 the supreme court considered whether 16% was a substantial enough percentage of the market foreclosed to violate the clayton act's exclusive dealing proscrip­ tion.108 the court concludes that "standard's use of the contracts creates just such a potential clog on competition as it was the purpose of section 3 to re­ move wherever, were it to become actual, it would impede a substantial amount of competitive activity. "109 in this case, 16% was enough market share to support a clayton act section 3 violation. the alternative approach that courts have used is a qualitative analysis of whether exclusive dealing arrangements have foreclosed a substantial share of the relevant market. in tampa electric co. v. nashville coal co., 110 the supreme court utilized this approach. the qualitative approach says: [i]t is necessary to weigh the probable effect of the contract on the relevant area of effective competition, taking into account the relative strength of the parties, the proportionate volume of commerce involved in relation to the total volume of commerce in the relevant market area, and the probable immediate and future effects which pre-emption of that share of the market might have on effective competition therein.111 105. for example, the product market for q-tips may include cotton balls, but the product market for a specialized catheter may be more limited. 106. standard oil co. of cal. v. united states, 337 u.s. 293,310-14 (1949). 107. jd. at 295-96. 108. jd at 310-14. 109. id at 314. 110. tampa elec. co. v. nashville coal co., 365 u.s. 320,329 (1961). 111. id. 2005] the future of group purchasing organizations 191 this approach utilizes a factual inquiry, where percentage of market fore­ closure is only one factor in the analysis, as compared to the quantitative app~ch where a percentage is completely determinative of the substil11tiality of market foreclosure. in tampa electric, the court concluded that a require­ ments contract, which only foreclosed competition in less than 1% of the markc;t, did not ''tend to foreclose a substantial volume of competition."112 in the absence of the safety zone, applied medical could succeed on the substantiality element of the clayton section 3 claim under either test.· com­ petitormanufacturers oftrocars who enter into exclusive dealing arrangements with any of the major gpos foreclose competition, but the deciding factor will be found in determining how much competition is foreclosed by those con­ tracts. this determination will depend on the market share secured by each contract made. if one or two competitor manufacturers held exclusive dealing contracts with each of the seven major gpos, then nearly 85% of the market for trocars would be bound. based on the quantitative standard oil test, if 85% of the market were bound by exclusive dealing arrangements with only one or two manufacturers, then this would easily satisfy the substantiality requirement. under the qualitative tampa electric test with that same situation, the concentration of the trocar market that is bound by exclusive dealing arrange­ ments would be a heavy factor; however, a court would also consider the strength of the competitor manufacturers as sellers and the effects that fore· closure of the market would have on competition. the percentage of the market bound by the exclusive dealing contracts alone suggests that the strength of the one or two competitor manufacturers who have entered into these arrangements is great applied medical would be able to present, as evidence, its proposals to sell trocars at a 60% price reduction, which were rejected by the buyers involved in the agreements in question, to demonstrate the actual effects that market foreclosure is having on competition. under this analysis, applied medical would succeed on qualitative substantiality. if the market for trocars was less concentrated and involved several competitor manufacturers entering into exclusive dealing arrangements with individual gpos, then the amount of market foreclosure secured by each individual contract would probably fall short under both tests. the largest gpo, novation, only controls $19.6 billion of the $190 billion hospital pur­ chasing market. if the trocar purchases by novation's members were propor­ tionate to that purchasing ratio, then a competitor manufacturer entering into an exclusive dealing arrangement with novation would only foreclose just over 10% of the trocar market. under the quantitative test, that may be enough to show substantiality, but under the qualitative test, it may not. 112. id. at 335. this case is important solely for its application of a qualitative approach, because under the facts involved here, a quantitative analysis would have reached the same conclusion by the court. 192 indiana health law review [vol. 2:171 in barr laboratories, inc. v. abbott laboratories,113 barr alleged that contracts abbott secured with ''ten of the largest warehouse chain drugstores for the one-year period" to sell five types of adult erythromycin products violated section 3 of the clayton act.114 barr argued that this arrangement satisfied the quantitative substantiality test of standard oil, because abbott's agreements foreclosed 15% of the relevant mark:et.115 in barr laboratories, both the district court and the third circuit looked instead to the qualitative substantiality test of tampa electric and agreed that the 15% "market preemp­ tion resulting from the contracts did not portend an immediate or future anti­ competitive backlash."116 based on the court's application of the substan­ tiality test in barr laboratories, it is likely that the 10% market foreclosure, which could be possible through an exclusive dealing arrangement with nova­ tion, would not satisfy the qualitative or quantitative substantiality tests. finally, applied medical will have to rebut any procompetitive business justifications that its competitor manufacturers may have for entering into exclusive dealing arrangements. in barr laboratories, abbott alleged price advantages, convenience, and business goodwill as procompetitive justifica­ tions for entering into the exclusive dealing arrangements. 117 these justifica­ tions supported the court's conclusion that ''the contracts at issue did not con­ stitute impermissible exclusive dealing arrangements."118 applied medical's competitor manufacturers who have entered into exclusive dealing arrange­ ments with gpos could use efficiency justifications for their contracts with gpos. without the safety zone in place, efficiency concerns may be a heavy justification for applied medical to rebut. however, if applied medical could show that there has actually been a lessening of competition under the substantiality requirement, then legitimate business justifications may not be able to overcome that evidence. without the protection of the safety zone, applied medical would have solid footing in its claims against competitor manufacturers that have con­ tracted with gpos paying high administrative fees and using long-tenn, sole­ source requirements, and bundling contracts. with the safety zone in exis­ tence, however, the competitor manufacturers' potential violations of the anti­ trust laws are protected. when creating the antitrust safety zone, the purpose of the ftc and doj was to promote the economic efficiencies that group purchasing would yield. the agencies state that they will not challenge group purchasing arrangements that fall outside the safety zone which serve 113. barr lab., inc. v. abbott labs., 978 f .2d 98 (3d cir. 1992). 114. id at 104. 115. comparethisoutcometothatofstandardoi/, wherethemarketforec1osurewas 16%, and the supreme court held that 16% was enough to satisfy the substantiality requirement. standard oil co. of cal. v. united states, 337 u.s. 293, 295-96 (1949). 116. barr labs., inc., 978 f.2d at 111. 117. id. 118. id. 2005] the future of group purchasing organizations 193 economic efficiencies unless there is a "substantial risk of anticompetitive effects. "119 . one shortcoming of the enforcement policy that creates the safety zone for joint purchasing arrangements is that it discusses "entry barriers to forming new groups."120 the ftc and doj have looked at the group purchasing model only from the perspective of the buyer and the advantages that group purchasing provides for buyers. in that same context, the agencies also state that "if some competitors excluded from the arrangement are unable to com­ pete effectively without access to the arrangement, and competition is thereby harmed, antitrust concerns will exist."121 the competitors that the agencies refer to here are the health care providers who are members of the gpos. the current state of the safety zone enforcement policy is void of consideration for the impact antitrust protection will have on sellers that are trying to compete · within the hospital supply area. for over two years, the senate, gao, doj, and ftc studied several issues involving competition in the health care industry. the doj and ftc published a report concluding their review of the joint purchasing arrangement safety zone on july 23,2004 (''the report").122 the agencies determined that the gpo safety zone does not protect anticompetitive conduct and decided to leave the 1996 language of the safety zone intact. 123 as a result, gpos that currently use the contracting practices discussed herein will be free to con­ tinue using those practices with little fear of restriction. the agencies failed to modify the safety zone to reflect its impact on sellers who must compete for group purchasing contracts. the example of applied medical illustrates the market realities of group purchasing and its potential to threaten market entry for sellers. in an industry where patients' lives depend upon the availability of life-saving devices, it is imperative for the safety zone not to provide gpos with unfettered power over the .medical device industry. with the protection of the safety zone, gpos can assist large manufacturers in securing market share without limit by employing con­ tracting arrangements that violate the antitrust laws outside of the group pur­ chasing context.124 119. u.s. dep't of justice & fed. trade comm., supra note 26, at 57. 120. ld. at 58 (emphasis added). 121. ld. 122. press release, federal trade commission, ftc andooj issue report on competition and health care (july 23, 2004), at http://www.ftc.gov/opa/2004/07/healthcarerpt.htm (last visited apr. 16, 2005) (on file with the indiana health law review). 123. !d. 124. this is the case as long as each contracting gpo can meet the requirements of the safety zone. 194 indiana healrn law review [vol. 2:171 the report of the doj and ftc reviews the testimony and feedback that the agencies received in conducting their two year review of the safety zone.125 yet, only two paragraphs of this nearly four-hundred page report address the agencies' conclusions about the future of the gpo safety zone after reviewing the available information on competition in the medical-supply industry.126 the overall conclusion of the agencies is that it would be impractical for statement 7,127 which created the gpo safety zone, to address all of the possible competition issues that could derive from the creation of a safe harbor.128 therefore, the agencies conclude that when statement 7 is silent on an activity (e.g., the use of exclusionary contracting practices), gpos ought not to interpret that silence as legal endorsement for the activity. 129 the agencies have effectively side-stepped addressing two years' worth of concerns about gpos' contracting practices in their report. the report states that "[ n ]o statement is likely to cover every issue that could arise. the agencies believe amending the statement to address some, but not all potential issues, is likely to be counterproductive."130 in addition, the report says that statement 7 does not preclude agency or third-party initiated investigations of alleged abuses of the safety zone.131 in the context of tiering and pay-for-per­ formance programs, the report says that the agencies will challenge "bundled contracting practices, where appropriate.''132 however, the report does not expressly outlaw any contracting activities and lacks clear rules defining improper activities under statement 7. as a result, the phenomenon discussed earlier in this article, where one manufacturer could hold individual contracts with the seven largest gpos­ binding nearly 85% of hospital purchases-without undergoing agency scru­ tiny, is still possible today. the only recourse available to a supplier that is denied entry to the marketplace under these circumstances is notifying the doj and ftc of the alleged violation. consequently, the agencies might review that complaint. nevertheless, the agencies have not established formal reporting or response systems to handle these violations. if the safety zone forecloses antitrust enforcement (apart from the agencies' case-by-case review of complaints) as a remedy for manufacturers like applied medical, which has been closed out of the trocar market, then 125. u.s. dep't of justice & fed. trade comm., improving heal1h care: a dose of competition 34-36 (july 2004), available at http://www.ftc.gov/reports/healthcare/040723 healthcarerpt.pdf. 126. /d. at 46. 127. u.s.dep'tofjustice&fed. tradecomm.,supranote26, at53-60. 128. u.s. dep't of justice & fed. trade comm.,supra note 125, at 46 {stating that the report is also "silent on other potential competitive concerns, such as price-fixing, market allocation, mergers, etc."). 129. id 130. id 131. id. 132. id at 47 {emphasis added). 2005] the future of group purchasing 0rganiza tions 195 what recourse do the agencies or gpos themselves have in dispelling concerns over current contracting practices? v. the safety zone's road ahead since the government's inquiries into gpos and their contracting practices, many gpos and the health industry group purchasing association ("higpa") have issued codes of conduct which detail the principles that group purchasers will follow in doing business. prompted by the govern­ ment's hearings a few years ago, higpa established a "code of conduct principles" to guide the gpo members of its trade association. this may be a step in the right direction, but higpa 's code of conduct falls short of safe­ guarding the contracting process, because it fails to expressly restrict admini­ strative fees, product bundling, or the combination use of long-term, sole­ source, requirements contracts.133 following higpa's lead, novation, the largest gpo, issued its own code of conduct on august 8, 2002. novation's code makes participation in novation-negoatiated contracts completely volun­ tary and not a condition of membership in the gpo. its code also restricts contracts to terms of three years or less, restricts administrative fees to 3% or less, and rejects advance payments as part of a contract award. 134 while novation's code of conduct takes a firmer position on contracting practices than higpa's code, the common flaw in the codes of conduct industry-wide is that they are not legally enforceable regulations, but merely propositions for doing business. the codes of conduct are not binding on the gpos who make or agree to follow them. furthermore, '"[a ]greements fixing prices and related terms of sales are unlawful per se.'" 135 if gpos collude to establish restrictions on the terms of their sales, then those restrictions may be subject to antitrust challenge.136 as a result, the agencies are best positioned to establish clear and defined rules for permissible contracting practices. the agencies' report falls short of remedying the potential market share foreclosure that confronts small medical device companies, like applied medical, today. in lieu of expanding statement 7 to become an all-encom133. health indus. purchasing ass'n, health industry purchasing association code of conduct principles 5 (july 24, 2002), available at http://www.higpa.orglpressroom/2002/7-29higpacode.pdf. 134. press release, novation commits to new operating principles to enhance value and opportunities for hospitals and suppliers (august 8, 2002) (on file with indiana health law review). 135. hospital group purchasing: has the market become more open to competition: before the subcomm. on antitrust, competition policy and consumer rights s. comm. on judiciary, at 2 (sept. 26, 2003) (statement of robert betz, ph.d., president & ceo, health industry group purchasing association) (quoting letter from herbert hovenkamp, professor, univ. of iowa, college of law, to higpa (june 21, 2002)) (emphasis added), at http://www.higpa.orglpdf/07-16-2003_testimony.pdf. 136. id at3. 196 llid~ah~thlawrevffiw [vol. 2:171 passing set of safe harbor rules, the agencies should issue formal guidance to the gpo and supply industries on appropriate contracting procedures. in addition, the agencies have enforcement authority among their powers to investigate and respond to anti competitive contracting practices, in accordance with the case-by-case review process described in their 2004 report this is necessary in order to close the loopholes for illegal tying, monopolization, attempted monopolization, and exclusive dealing, which statement 7 and the report do not expressly prohibit. as the law and the government's interpretations stand today, the safety zone is vulnerable to becoming a safe harbor for disguised anticompetitive conduct. the agencies' conclusion, that statement 7's silence on prohibited contracting practices does not represent the government's blessing to engage in those practices, thoughtfully avoids the antitrust concerns that device com­ panies spent over two years raising. yet, current safety zone guidelines are completely devoid of the realities of gpo dealings. statement 7 only addresses "horizontal agreements among hospitals to form a gp0."137 state­ ment 7 entirely lacks any information on the vertical arrangements into which gpos, falling within the safety zone, may enter. in order to protect medical device manufacturers and ensure a competitive market for their products, the agencies need to reconsider the conclusions of their report and issue guidance to the supply industry or pursue enforcement of anticompetitive contracting practices. vi. conclusion gpos may be threatening the competitive marketplace for medical devices and consumer access to affordable, quality devices. the safety zone from antitrust enforcement, created by the ftc and ooj for joint purchasing arrangements, has both advanced and hindered the hospital supply area, particularly in the field of medical devices. the formation of gpos bas pro­ duced many transactional benefits, such as stream-lining the marketing process for manufacturers and negotiating discounts for their member pro­ viders that keep the cost of health care down for consumers. the group pur­ chasing model coupled with an antitrust safety zone, while efficient horizon­ tally, has vertical shortcomings demonstrated by the agreements that gpos are making with manufacturers. because joint purchasing arrangements that qualify for the safety zone are immune from antitrust enforcement absent extraordinary circumstances, gpos can take advantage of the antitrust exemp­ tion by utilizing exclusionary contract terms, which but for the safety zone would violate the antitrust laws. exclusionary contracting practices jeopardize market share and market entry for medical device manufacturers. the agencies have fallen short on 137. elhauge, supra note 33, at l. 2005] the future of group purchasing organizations 197 their promise to revisit the safety zone and address the concerns of those affected by current practices under the safe harbor. the agencies still have an opportunity to issue guidance to the supply industry or, even better, to take enforcement action against gpos and large suppliers that engage in anti­ competitive contracting practices. life-saving medical devices are an integral part of the health care system, and the government must actively ensure that antitrust exemption does not deny manufacturers the ability to bring new devices and technologies to market. physician owned hospitals: congress should change the aca’s course of treatment melissa c. schade van westrum* i. introduction ................................................................. 812 a. the issue .................................................................... 813 b. roadmap ..................................................................... 814 ii. background .................................................................. 814 a. federal anti-kickback statute ................................. 816 b. stark law ................................................................... 817 c. medicare modernization act ..................................... 818 iii. implementation of the aca ..................................... 819 a. aca changes ............................................................. 821 1. disclosures .............................................................. 824 2. bona fide investment ............................................. 825 b. exceptions to the law ............................................... 827 c. physician hospitals of america v. sebelius .............. 829 iv. analysis ....................................................................... 831 a. quality ........................................................................ 832 1. focus factories ....................................................... 833 2. the physician knows best ..................................... 836 3. name on the door ................................................... 837 b. cost ............................................................................. 839 1. patient costs ........................................................... 839 2. sunk costs for physician owned hospitals ........... 841 3. competition for patients ......................................... 843 4. community benefits ............................................... 844 c. conflict of interest ..................................................... 848 v. conclusion ................................................................... 853 * j.d. candidate, 2016, indiana university robert h. mckinney school of law; m.b.a. candidate, 2016, indiana university kelley school of business; b.s., 2009, purdue university. http://dx.doi.org/10.18060/3911.0009 812 indiana health law review vol. 12:2 i. introduction orthoindy, a physician-owned group that owns indiana orthopaedic hospital,1 announced in 2008 the opening of a new $20 million dollar outpatient facility on the south side of indianapolis.2 unfortunately for orthoindy, the passage of the affordable care act (“aca”) in 2010 altered its plans. section 6001 of the aca limits medicare payments to physician-owned hospitals for services performed for medicare patients referred by physician-owners.3 existing physician-owned hospitals are grandfathered under the plan and allowed to continue to treat medicare patients and receive payments.4 however, in order to expand a physician-owned hospital’s existing facilities, a hospital must meet certain requirements to qualify for an exception and obtain permission from the secretary of the department of health and human services (“hhs”).5 if the physician-owned hospital fails to meet these requirements but expands its facilities, the physician-owned hospital risks losing its medicare payments.6 medicare is the largest insurer in the united states, and loss of medicare reimbursement payments would likely mean the physicianowned hospital must shut down.7 because of the necessity 1 j.k. wall, orthoindy looks to loopholes for growth, indianapolis bus. j. (may 23, 2011), http://www.ibj.com/orthoindy-looks-to-loopholesfor-growth/params/article/27316 [hereinafter loopholes]. 2 orthoindy planning greenwood center, indianapolis bus. j. (dec. 11, 2008), http://www.ibj.com/orthoindy-planning-greenwoodcenter/params/article/10536. 3 42 u.s.c. § 1395nn (2015); physician hosps. of am. v. sebilius, 691 f.3d 649, 651 (5th cir. 2012). 4 physician hosps. of am., 691 f.3d at 652. 5 id. 6 ken terry, reform law cuts off specialty hospitals just in time to prevent explosive growth, cbs news, http://www.cbsnews.com /8301-505123_162-43842312/reform-law-cuts-off-specialty-hospitalsjust-in-time-to-prevent-explosive-growth/ (last updated jan. 4, 2011, 7:25 pm). 7 j.k. wall, iu health buying docs in hospital ventures, indianapolis bus. j. (may 23, 2011), http://www.ibj.com/iu-buying-out2015 physician owned hospitals 813 of medicare payments and the money they had already spent on the new facility, orthoindy eliminated four beds at its indiana orthopaedic hospital in order to open four operating rooms in the new facility in march 2011.8 a. the issue by barring new physician-owned hospitals from obtaining medicare certification, the aca effectively bans the creation of new physician-owned hospitals.9 the aca also drastically restricts the expansion of current physicianowned hospitals.10 the american medical association and other related medical organizations support physicianownership of hospitals because physician-owned hospitals “introduce healthy competition to the marketplace, increase high-quality care choices for patients and give physicians an alternative to more traditional hospital employment arrangements.”11 the aca’s language not only targets specialty hospitals, but also multispecialty hospitals, acute care facilities, and community hospitals supported by practicing physician investors.12 this note focuses mostly docs-in-hospital-ventures/params/article/27315 [hereinafter iu health]. 8 loopholes, supra note 1. 9 see tanya albert henry, physician-owned hospitals seize their moment, am. med. news (apr. 29, 2013), http://www.amednews.com/article/20130429/government/130429948/4/; david whelan, obamacare’s first victim: physician-owned specialty hospitals, forbes (apr. 5, 2010, 4:46 pm), http://www.forbes.com/sites/sciencebiz/2010/04/05/obamacares-firstvictim-physician-owned-specialty-hospitals/; elise dunitz brennan & hilary l. velandia, do the ppaca amendments to the stark whole hospital exception mean the evolution of a two-tier system?, 4 j. health & life sci. l. 40, 47 (2010). 10 henry, supra note 9. 11 david glendinning, house bills would lift ban on physicianowned hospitals, am. med. news (mar. 31, 2011), http://www.amednews.com/article/20110331/government/303319996/8/. 12 id.; leigh walton, hospital syndications: opportunities and options or poised for extinction?, 21 health law. 1 (2009), available at http://www.americanbar.org/publications/health_lawyer_home/health_0 3_publications_healthlawyer_vol_21.html. 814 indiana health law review vol. 12:2 on the specialty hospitals because of the lack of research on the other physician owned hospitals. congress should repeal section 6001 of the aca providing for limits on physician-owned hospitals as section 6001 does not serve the needs of patients by improving health care quality, lowing health care costs, or resolving any issues regarding conflicts of interest. b. roadmap this note discusses the effects of the aca changes on physician-owned hospitals. part ii begins with a short history of physician-owned hospitals and then describes the effects of the stark law, the medicare modernization act, and federal anti-kickback statutes on physician-owned hospitals. part iii examines section 6001 of the aca and its effects on physician-owned hospitals. part iii finishes with an examination of a lawsuit brought against hhs by physician hospitals of america and texas spine and joint hospital, and the reasons for the case’s dismissal. part iv analyzes the arguments for and against the existence and expansion of physician-owned hospitals, focusing on three major arguments: the quality of care provided by physicianowned hospitals, the effects of physician-owned hospitals on the cost of care, and the potential conflicts of interest involved in physician referrals to hospitals in which the physician has an investment interest. physician owned hospitals provide outstanding quality healthcare at a lower cost and claims of potential physician conflicts of interest are grossly overstated. for these reasons section 6001 should be repealed, allowing physician owned hospitals to compete in the market on even footing with community hospitals. ii. background for the majority of america’s existence, most physicians have practiced unaffiliated to an organization.13 but in the 13 joshua e. perry, a mortal wound for physician-owned specialty hospitals? the legal and ethical prognosis for market-driven, 2015 physician owned hospitals 815 20th century, physicians began joining group practices for a variety of capital and business related reasons.14 community hospitals formed and began providing a wide range of services, and the government began requiring hospitals to provide some unprofitable services for the community good.15 government regulations were also developed to prohibit hospitals from “dumping” unprofitable patients.16 physicians began to seek new ways to have more control over the operations of the hospital because the physicians felt the community hospitals were unresponsive to the physicians’ needs and ideas.17 in the 1980s, physician ownership of non-hospital facilities began expanding due to changes in the health care payment structure which caused doctors to pursue control over the facilities in which the physicians practice and new ways to supplement their incomes.18 by virtue of the physicians’ ownership and management interests in these facilities, physicians could control the hiring of staff, which equipment to purchase, procedure schedules, and other entrepreneurial medicine in the wake of 2010 health care insurance reforms 1, 27 (2010), http://papers.ssrn.com/sol3 /papers.cfm?abstract_id=1607029. 14 id. 15 david a. argue, an economic model of competition between general hospitals and physician-owned specialty facilities, 52 antitrust bull. 347, 348 (2007). 16 id. at 349; emergency medical treatment and labor act (emtala), centers for medicare & medicaid servs., https://www.cms.gov/regulations-andguidance/legislation/emtala/index.html?redirect=/emtala (last visited apr. 29, 2015) (emtala was enacted by congress in 1986 in order to “ensure public access to emergency services regardless of ability to pay.” medicare-participating hospitals are required to provide a medical screening exam when requested to treat a patient with an emergency medical condition. hospitals are then required to provide stabilizing treatment for patients with emergency medical conditions or transfer the patient if the hospital does not have the ability to stabilize the patient.). 17 kathryn macgregor, specialty hospitals: a healthy addition to the healthcare market?, 13 mich. st. j. med. & law 239, 241 (2009); argue, supra note 15, at 349. 18 patrick a. sutton, the stark law in retrospect, 20 annals health l. 15, 17 (2011); argue, supra note 15, at 349. 816 indiana health law review vol. 12:2 hospital administrative decisions. in a community hospital, these are all choices that are made by the non-medical hospital administration.19 in efforts to control what the government believed to be conflicts of interest created by physician-ownership of these medical facilities receiving federal reimbursements, congress implemented the federal anti-kickback statue, passed the stark law, and placed a temporary moratorium on physician-owned hospital creation with the medicare prescription drug, improvement, and modernization act.20 a. federal anti-kickback statute the medicare anti-fraud and abuse statute of 1972 (“anti-kickback statute”) created a criminal offense to offer, pay, or receive compensation for referrals for services that are reimbursed by any federal or state health care program.21 violating the anti-kickback statue can result in fines, imprisonment, or both and automatic exclusion from federal health care insurance programs.22 the antikickback statute was intended to prevent providers from making medical decisions based on the physician’s own selfinterest that could harm medicare and medicaid programs through increased costs and abusive practices.23 by preventing these decisions, the anti-kickback statute aimed to “prevent overutilization, limit cost, preserve freedom of choice and preserve competition.”24 congress 19 macgregor, supra note 17, at 241 (noting that physician productivity is increased when physician-owners control operations because there are fewer schedule disruptions, more efficient operating room turnover, and more control over operating room staff. this also improves productivity for non-owners who work in the hospital.). 20 see david w. hilgers & sidney s. welch, physicians postppaca: not going bust at the healthcare buffet, 24 health law. 1, 3 (2012); walton, supra note 12. 21 42 u.s.c. § 1320a-7b (2015); walton, supra note 12; perry, supra note 13, at 21. 22 42 u.s.c. § 1320a-7b (2015). 23 guidance on the federal anti-kickback law, program assistance letter 1995-10, health resources and services administration, http://bphc.hrsa.gov/programrequirements/policies/pal199510.html. 24 id. 2015 physician owned hospitals 817 instructed the hhs office of inspector general to promulgate rules to determine which actions would and would not constitute violations of the anti-kickback statute, thereby creating safe harbors to allow for conduct that would benefit the health care system.25 congress became concerned that the anti-kickback statute and the safe harbors create by the hhs were not adequately curtailing fraudulent behavior in the health care system.26 representative fortney h. (pete) stark from california proposed legislation intended to broaden the prohibition of medicare and medicaid fraud.27 b. stark law section 1877 of the social security act,28 commonly referred to as “the stark law,” was passed in 1989 as a prohibition on physician referrals for laboratory services to an entity in which the physician has ownership interest. it was later was expanded to include many other services and other methods of compensation from medical facilities.29 congress enacted this law after studies found that physicians with ownership interests in freestanding clinical laboratories, diagnostic imaging centers, or physical therapy centers ordered more services for patients than physicians with no ownership interest.30 the stark law states that when a physician (or an immediate family member) has a direct or indirect ownership interest, investment interest, or compensation arrangement in a hospital, he is prohibited from referring a patient, covered by the medicare program, for “designated 25 perry, supra note 13, at 21. 26 id. at 23. 27 id. at 24. 28 michael o. leavitt, study of physician-owned specialty hospitals required in section 507(c)(2) of the medicare prescription drug, improvement, and modernization act of 2003, 1 (2005), http://news.heartland.org/sites/all/modules/custom/heartland_migration/ files/pdfs/19681.pdf. 29 sutton, supra note 18, at 15. 30 leavitt, supra note 28. 818 indiana health law review vol. 12:2 health services” to the entity unless an exception applies.31 designated health services include services such as physical therapy, occupational therapy, radiology, providing durable medical equipment, providing nutrition equipment and supplies, providing outpatient prescription drugs, ambulance services, home infusion therapy, and inpatient and outpatient hospital services.32 however, if a physician’s ownership or investment interest is in the “whole hospital” then the stark law’s “whole hospital exception” applies.33 this exception allows physicians with an ownership or investment interest in a hospital to refer patients to that hospital as long as the referring physician has privileges to treat patients at the hospital and the referring physician’s financial interest is in the whole hospital, not just a part of the hospital.34 c. medicare modernization act in response to a rising number of physician-owned specialty hospitals, congress included restrictions on physician-owned hospitals in the medicare prescription drug, improvement, and modernization act of 2003 (“mma”).35 for 18 months beginning on december 8, 2003, physicians were prohibited from referring medicare or medicaid patients to specialty hospitals in which the 31 42 u.s.c §1395nn(a) (2015); kathy l. poppitt, physician ownership of hospitals: identifying and dealing with the restrictions, options and risks following the enactment of aca and recent litigation, http://www.coxsmith.com/portalresource/lookup/wosid/intelliun-1058302/media.name=/library1poppittpresentation.pdf. 32 sutton, supra note 18, at 22. 33 walton, supra note 12. 34 howard fredrick hahn & torri a. criger, health care reform’s impact on physician-owned hospitals, j. health care compliance 63, 63 (2010), http://www.huschblackwell.com/~/media/files /businessinsights/businessinsights/2010/09/health%20care%20reform s%20impact%20on%20physicianowned%20hos__/files/health%20care %20reforms%20impact%20on%20physicianowned%20hos__/fileattac hment/100901_hahn.pdf. 35 physician hosps. of am. v. sebilius, 691 f.3d 649, 652 (5th cir. 2012). 2015 physician owned hospitals 819 physician had an investment interest.36 this included referrals that previously were allowed under the “whole hospital” exception.37 the moratorium was meant to prohibit creation of new physician-owned specialty hospitals.38 on june 9, 2005, the centers for medicare and medicaid services (“cms”) suspended processing of specialty hospital medicare enrollment applications, effectively extending the moratorium for an additional six months.39 section 507 of the mma required the medicare payment advisory commission (“medpac”) and the secretary of the department of health and human services (“hhs”) to study physician-owned hospitals and report the results to congress (“medpac report”).40 specifically, the medpac report examined physician-owners referral patterns; compared quality of care and patient satisfaction between physician-owned hospitals and community hospitals; evaluated the differences in uncompensated care between physician-owned hospitals and community hospitals; and assessed the relative exemption of community hospitals.41 medpac analyzed medicare’s cost reports and inpatient claims to determine the cost effectiveness of physicianowned hospitals and the incentives for patient selection.42 the results of this study are discussed throughout this note. iii. implementation of the aca reforms in the past, including the stark law, have targeted physician-owned specialty facilities like cardiac, 36 poppitt, supra note 31, at 1. 37 id. 38 brennan & velandia, supra note 9. 39 poppitt, supra note 31, at 1. 40 leavitt, supra note 28, at i. 41 id. 42 report to the congress: physician-owned specialty hospitals, medicare payment advisory commission vii (2005), http://medpac.gov/documents/reports/mar05_spechospitals [hereinafter medpac report]. 820 indiana health law review vol. 12:2 orthopedic, or other surgical facilities that focus on a select few services.43 the reforms have focused on these facilities because the government believes that there is a financial incentive for physician-owners to refer patients to these owned facilities and to over-utilize procedures. the medpac report found that ownership had an effect (albeit a weak effect) on physician-owners referring patients to physician-owned specialty hospitals.44 there was a “mildly positive correlation between the size of the physician’s ownership share and the percentage of his or her patients treated at the specialty hospital.”45 hhs also found that some hospitals had a difference in referral rates between physician-owners and non-owners, and some hospitals did not have referral rates without significant differences between physician-owners and non-owners.46 section 6001 of the aca eliminates the “whole hospital” exception for all physician-owned hospitals without medicare provider agreements before december 31, 2010 and significantly limits the ability for physician-owned hospitals grandfathered under the law to expand and still receive medicare reimbursements.47 these changes will likely lead to the elimination of physician-owned hospitals and deprive americans of the innovations in medical procedure and efficient hospital administration practices that the entrepreneurial physician-owners develop. 43 chris silva, physician-owned hospitals: endangered species?, am. med. news (june 28, 2010), http://www.amednews.com/article /20100628/government/306289947/4/. 44 argue, supra note 15, at 351. 45 leavitt, supra note 28, at 26; see also argue, supra note 15, at 351; ashley swanson, physician ownership and incentives: evidence from cardiac care, 38 (2012) http://econweb.umd.edu/~davis /eventpapers/swansonphysician.pdf (“[t]he results on physician share do not suggest that financial stake impacts cherry-picking behavior.”). 46 argue, supra note 15, at 351; see swanson, supra note 45 (“[f]or markets with specialized physician-owned hospitals, physician-owners have a strong preference for treating at their owned facility and that owner preferences over hospitals do not differ substantially from those of non-owners in how they vary with patient characteristics.”). 47 poppitt, supra note 31, at 4. 2015 physician owned hospitals 821 a. aca changes section 6001 of the aca prohibits the creation of new physician-owned hospitals and the expansion of grandfathered physician-owned hospitals by restricting the stark law whole hospital exception.48 hospitals with a provider agreement in effect on or before december 31, 2010 and physician ownership on or before march 31, 2010 are grandfathered under the law. being grandfathered under the law means that physicians with ownership are permitted to refer medicare beneficiaries to the hospital without violating the stark law.49 however, physicianowned hospitals are prohibited from increasing the total number of beds, operating rooms, or procedure rooms from the number licensed on march 23, 2010, the day that aca was enacted, the “baseline” number.50 procedure rooms include rooms where catheterizations, angiographies, angiograms, and endoscopies are performed but, as of now, do not include rooms where ct, pet, or other services not specifically listed in the bill are performed.51 cms acknowledged that some states only license the number of beds and not the number of operating or procedure rooms. however, regardless of whether a state licenses the operating or procedure rooms, hospitals are prohibited from expanding the number of rooms without obtaining an exception.52 according to cms’s comments regarding the aca amendments to the “whole hospital” exception, a hospital may convert beds into procedure rooms or procedure rooms to beds as long as the aggregate number does not increase above the baseline.53 if a hospital was in the process of expanding the number of beds and rooms on march 23, 2010 but the beds and rooms were not in existence on the date, the beds and rooms are not counted in 48 brennan & velandia, supra note 9. 49 hahn & criger, supra note 34, at 64. 50 id. 51 id. 52 poppitt, supra note 31, at 8. 53 75 fed. reg 71800, 72243 (2010); poppitt, supra note 31, at 12. 822 indiana health law review vol. 12:2 the baseline capacity for the hospital.54 if the rooms and/or beds are not counted in the baseline, the hospital cannot use them without eliminating beds or rooms elsewhere. the monies spent on the process of expanding are therefore wasted and a sunk cost for the hospital. section 6001 encompasses any facility that has physician ownership, even if that ownership is less than 1%.55 this includes acute care facilities, multispecialty hospitals, and community hospitals that physician-investors have financially assisted because the hospitals were struggling, although the literature generally discusses only the physician-owned specialty hospitals.56 examples of community hospitals that have paired with physicianinvestors are st. vincent’s in indianapolis, which partnered with physicians to build a heart hospital, and the baylor health system in dallas, which opened a series of specialty hospitals.57 these community hospitals decided their best interests lied in partnering with physicians rather than fighting the physicians. by partnering with the physicians, the community hospitals still receive a portion of the profits that the hospital otherwise may have lost from competition with a separate physician-owned hospital competitor. the community hospital also gains the added expertise and input of the physician co-owners in processes and procedures to make the hospital more efficient, safer, and a more conducive workplace for the medical staff. about 20% of baylor’s $3.5 billion in annual revenue comes from its partially physician-owned specialty facilities.58 these community hospitals will be unable to expand their specialty facilities because, prior to the aca’s enactment, the community hospital made a business decision to pair with physician-investors to expand the hospital’s medical practices. in freely competitive markets, more health care facilities may have joint-ventured with physicians if the aca had not prohibited medicare from extending provider 54 poppitt, supra note 31, at 8. 55 silva, supra note 43. 56 id. 57 terry, supra note 6. 58 id. 2015 physician owned hospitals 823 agreements to new physician-owned specialty hospitals.59 by financially collaborating with physicians, community hospitals could have taken advantage of the physicians’ expertise, funding, and loyalty. instead, community hospitals will continue to be managed by the career administrators who draw large salaries to continue the status quo of building larger hospital empires by squelching the managerial competition and innovation that could control health care costs.60 in 2011 indiana university health began buying out physician-owners of some of its hospitals.61 these hospitals were located in growing communities around indianapolis, and indiana university health wanted to be able to expand its facilities as needed to treat the expanding patient populations.62 because the aca prevents expansion of physician-owned hospitals, in order to have the option to expand, indiana university health had no choice but to undo its ownership relationship with the physicians.63 in a growing community, hospitals will necessarily need to expand to accommodate the citizens. here, indiana university health had partnered with physicians for the physicians’ skill and knowledge but, for the reason of being able to grow with the community, the hospital group had to sever that relationship. the ending of the agreement between the hospital system and the physicians will only be a detriment to the community in the long run because of the loss of the physician input. this buyout left indiana orthopaedic hospital as the only majority physician-owned hospital in the indianapolis area.64 these limitations on expansion created uncertainties for all physician-owned specialty hospitals in the process of expanding in 2010. for many hospital expansion projects 59 id. 60 regina herzlinger, who killed health care? america’s $2 trillion medical problem and the consumer-driven cure 62 (2007). 61 iu health, supra note 7. 62 id. 63 id. 64 id. 824 indiana health law review vol. 12:2 and new physician-owned hospitals in development, but not completed by the deadline, these limitations resulted in sunk costs for hospitals beginning construction prior to the reveal of the language of the aca legislation.65 new physician-owned hospitals and those in development, but not completed by december 31, 2010, fall under the scope of the stark law. because of the inability to expand, physician-owned hospitals will ultimately disappear. physicians will eventually sell their shares to community hospitals, like in the case of indiana university health, or the physician-owned hospitals will fail financially because the physician-owned hospitals are prevented from truly competing in the marketplace. 1. disclosures the aca requires disclosures to create transparency at physician-owned hospitals. the government believes that receiving revenue through ownership or compensation agreements encourages overutilization of the services a facility provides and by disclosing the financial relationship, patients are given the opportunity to seek the service from another provider.66 the hospital must disclose the identities of all investors and the nature and extent of investment terms to hhs annually.67 hospitals must also require each physician-owner or investor to provide, for patients being referred, disclosures of the referring physician’s ownership or investment interest in the hospital as well as the treating physician’s ownership or investment in the hospital.68 physician-owned hospitals are required to disclose their status as a partially or wholly physicianowned hospital on all advertising and public websites.69 65 physician hosps. of am. v. sebelius, 691 f.3d 649, 652 (5th cir. 2012); david hogberg, obamacare will effectively bar new physicianowned hospitals, investor’s bus. daily (mar. 24, 2010, 7:25 pm), http://news.investors.com/032410-528337-obamacare-will-effectivelybar-new-physician-owned-hospitals.htm [hereinafter hogberg ban]. 66 see hilgers & welch, supra note 20, at 5. 67 perry, supra note 13, at 42. 68 id. 69 id. 2015 physician owned hospitals 825 hospitals may not require any physician with direct or indirect ownership interests to make or influence referrals or to generate business for the hospital.70 not only are disclosures required to inform patients of the financial interests of their treating physicians, further disclosures are required to inform patients of any potential safety concerns. if a physician is not available on the premises at all times, the hospital must inform patients and receive a signed acknowledgment form from each patient indicating the patient’s understanding.71 if a physician is not always present on the premises, the patient may be put at risk if complications arise. the acknowledgment form makes sure that the patient is aware of this fact. the hospital must have the capacity to provide initial evaluation and treatment to all patients upon arrival and, when necessary, to transfer patients to hospitals with the capacity to treat the patient.72 moreover, all disclosures must be made in time to give the patient enough time to “make meaningful decisions regarding the receipt of care . . . .”73 disclosures are necessary to insure that patients are aware of potential conflicts of interest their physician may have and to inform patients of any potential safety concerns. the disclosures also give the patient the opportunity to seek the same services in another facility. 2. bona fide investment the aca also seeks to “ensur[e] bona fide investment[s].”74 “bona fide investments” means that the percentage of the total value of physician ownership or investment interests in the hospital does not exceed the percentage established on march 23, 2010, the “baseline percentage.”75 cms recognized that the bona fide 70 poppitt, supra note 31, at 5. 71 id. 72 id. 73 hahn & criger, supra note 34, at 64. 74 patient protection and affordable care act, pub. l. no. 148, 124 stat. 119, 685 (codified at 42 u.s.c. § 1395nn(i)(1)(d) (2015)). 75 poppitt, supra note 31, at 5. 826 indiana health law review vol. 12:2 investment level may fluctuate as long as the physician investment level stays at or below the baseline percentage of physician ownership established on march 23, 2010.76 in order to ensure that physician owners are not provided unethical incentives for patient referrals, limits are placed on the financial benefits of their ownership. physicians must not be offered ownership or investment interests or the opportunity to purchase or lease hospital property with more favorable terms than those offered to non-physician owners or investors.77 the hospital or any of its owners or investors, directly or indirectly, may not provide financing or make a loan, guarantee a loan, make payment toward a loan, or subsidize a loan in any way for or related to any individual physician or group of physicians to acquire ownership or investment interests in the hospital.78 returns must be distributed to the owners and investors in amounts directly proportional to the individual or organization’s ownership or interest in the hospital.79 physician owners and investors may not receive guaranteed receipt of or right to purchase any other hospital related business interests.80 these provisions were included to make sure that physician-owned hospitals cannot unethically influence their physicians to decide to refer patients to the facility for financial reasons. the aca also prohibits increasing the aggregate percentage of physicianownership of physician-owned hospitals or an entity whose assets include the hospital, above the baseline percentage as of march 23, 2010.81 the percentage may drop below the baseline percentage, and physicians can buy and sell shares, but the total physician ownership percentage can never go above the baseline. 76 id. at 8. 77 id. at 6. 78 id. 79 id. 80 id. 81 42 u.s.c § 1395nn(h)(7)(d)(i) (2015). 2015 physician owned hospitals 827 b. exceptions to the law a physician-owned hospital can apply for an exception to the stark law to allow the hospital to expand its number of beds, operating rooms, or procedure rooms.82 physicianowned hospitals can apply to hhs for one of two exceptions no more than once every two years and must wait for input from members of the community.83 in order to qualify for an exception as an applicable hospital, the hospital must (a) be located in a county with population growth over the last five years at 150 percent that of the state; (b) be located in a state with an average bed capacity less than the national average; (c) have a total percentage of medicaid patients greater than or equal to the average percentage of medicaid patients treated by all hospitals in the county; (d) not “discriminate against beneficiaries of federal health care programs and [] not permit physicians practicing at the hospital to discriminate . . .”; and (e) have an average bed occupancy rate greater than the average bed occupancy rate of the state.84 in order to qualify as a high medicaid facility, a hospital (a) cannot be the only hospital in the county; (b) have, in the most recent three years, an annual percent of inpatient medicaid admissions greater than inpatient medicaid admissions for any other hospital in the county; and (c) cannot “discriminate against beneficiaries of federal health care programs and [] not permit physicians practicing at the hospital to discriminate . . . .”85 these exceptions are both very strict and will be difficult, if not impossible, for any physician-owned hospital to achieve. another issue with the exception requirements is that the data used to demonstrate the medicaid admissions data, which comes from the healthcare cost report information system (“hcris”), is not without its limitations.86 the data 82 brennan & velandia, supra note 9. 83 hogberg ban, supra note 65. 84 42 u.s.c. § 1395nn(i)(3)(e) (2015). 85 id. § 1395nn(h)(3)(f). 86 cms issues proposed rule affecting physician-owned hospital expansion requests, hall render killian heath & lyman (july 16, 2014), http://www.hallrender.com/resources/article/1906/. 828 indiana health law review vol. 12:2 does not include medicaid managed care admissions and discharges, and hospitals not participating as medicare providers in the three most recent fiscal years would not have their data included in the hcris.87 because of its limitations, this data has prevented physician-owned hospitals from applying for exceptions the hospitals would otherwise be eligible for.88 in these cases, the community needs expanded facilities, but regulations prohibit physician-owned hospitals from growing to meet this demand. consequently, patients suffer by having to wait longer than necessary for procedures because the facilities are not large enough to meet the community’s demand. in the 2015 final rule, cms allows for the use of supplemental data sources only until revised hospital cost reports can include information on medicaid managed care discharge data.89 also, the 2015 final rule amended the fiscal year standard by bifurcating it into separate standards for medicaid inpatient admissions data and average bed capacity and occupancy. the medicaid inpatient admissions data is interpreted as the 12-month period containing all the required information from the requesting hospital and all hospitals that the requesting hospital must compare itself.90 the average bed capacity and occupancy hcris data includes is the most recent fiscal year with enough data to determine the average bed capacity and bed occupancy for the state and the nation.91 even if a hospital meets all the requirements and is granted an exception, the law prohibits the hospital from expanding more than 200 percent from its “baseline” number of beds, operating rooms, or procedure rooms, and the expansion may only occur on the hospital’s main campus.92 the cms’s exception determination is prohibited 87 id. 88 id. 89 cms issues amended final rule impacting physician-owned hospital expansion requests, hall render killian heath & lyman (nov. 11, 2014), http://www.hallrender.com/resources/article/2027/. 90 id. 91 id. 92 hogberg ban, supra note 65; hahn & criger, supra note 34, at 65. 2015 physician owned hospitals 829 from review by any administrative or judicial proceedings according to the aca.93 c. physician hospitals of america v. sebelius because of these changes, physician hospitals of america and texas spine & joint hospital jointly filed suit against kathleen sebelius, secretary of the department of health and human services (“hhs secretary”), in u.s. federal court for the eastern district of texas.94 the plaintiffs were seeking a declaratory judgment and injunctive relief from section 6001 of aca, alleging that the provision is unconstitutional because of a violation of due process and of equal protection rights and is void for vagueness.95 physician hospitals of america (“pha”) is an organization dedicated to supporting the interests of physician-owned hospitals.96 texas spine & joint hospital (“tsjh”) is a physician-owned hospital in texas that, in 2008 prior to any discussion of or passage of the aca, had decided to expand its facilities and had already invested $3 million towards the $30 million expansion.97 the district court denied the secretary’s motion to dismiss for lack of jurisdiction but found that congress had a rational basis for passing section 6001, that section 6001 does not create a real or regulatory taking, and the requirements are not unconstitutionally vague.98 the plaintiffs appealed. the fifth circuit vacated the district court’s decision and dismissed the action because the court found that the federal courts lacked subject matter jurisdiction.99 the court found that the claims arose under the medicare act, which requires that all legal claims be 93 poppitt, supra note 31, at 7. 94 physician hosps. of am. v. sebilius, 691 f.3d 649 (5th cir. 2012). 95 id. at 652. 96 id. 97 id. 98 id. at 651. 99 id. at 659. 830 indiana health law review vol. 12:2 presented first to the hhs secretary.100 title 42, section 1395ii substitutes the hhs secretary for the social security commissioner in 42 u.s.c. § 405(h) and, in doing so, making section 405(g) applicable to medicare claims.101 only after the hhs secretary renders a final decision can a party to the administrative proceeding “obtain a review of such decision by a civil action . . . .”102 this failure to pursue first an administrative proceeding left the district court without subject-matter jurisdiction over the claim.103 only by experiencing a “complete preclusion of judicial review” will a party be able to litigate its claims in federal court without having to fulfill the requirement to seek administrative proceedings.104 the plaintiffs argued that the illinois counsel exception applied in this case. in shalala v. illinois council on long term care, inc., the court concluded that section 405(h) does not apply when application “would not simply channel review through the agency, but would mean no review at all.”105 this means that the party would be unable to complete the administrative requirements in order to receive an administrative ruling. without an administrative ruling, the party could not appeal to the court system for judicial review. the plaintiffs argued that the illinois council exception applies because the administrative proceeding “would result in the practical denial of judicial review.”106 the plaintiffs would have to complete construction on the hospital expansion, treat a patient in the new facilities, be denied the claim for medicare reimbursement, file the administrative claim with the hhs secretary, and be denied again (possibly risking losing medicare reimbursements on the existing facility) all before the hospitals are able to bring the claim in federal 100 id. at 653. 101 id. at 659. 102 42 u.s.c. § 405(g) (2015). 103 physician hosps. of am., 691 f.3d at 653. 104 id. 105 shalala v. ill. council on long term care, inc., 529 u.s. 1, 19 (2000). 106 physician hosps. of am., 691 f.3d at 656. 2015 physician owned hospitals 831 court.107 the court rejected this argument because the courts are not concerned with whether the instant plaintiffs are unable to bring their claim, but whether no one may bring the claim leaving “no other path for judicial review.”108 “a party may not circumvent the channeling requirement by showing merely that ‘postponement of judicial review would mean added inconvenience or cost in an isolated, particular case.’”109 while another physicianowned hospital could possibly bring this claim against the hhs secretary, that hospital will have the same issues as texas spine & joint. the physician-owned hospital will have spend money to build a facility to completion so that the hospital can treat a patient, bill medicare for reimbursement, have the reimbursement request rejected, and go through the medicare act administrative proceedings all before the hospital can file a claim in court. the illinois council exception should apply in this case so that physician-owned hospitals can have their claims heard by an impartial court. without the exception, the physician-owned hospital industry will never be able to have their concerns heard and ruled upon. iv. analysis when the aca was passed in 2010 there were 265 physician-owned hospitals in the united states, but four years later that number has dropped to 238.110 the over10% drop is proof that section 6001 has upset the physicianowned hospital industry. in the mean time, the cms has released the data for its new hospital value based purchasing program that ranks 3428 hospitals nationally based on the hospital’s quality.111 physician-owned hospitals claim 9 of the top 10 spots and 48 of the top 100 107 id. 108 id. 109 id. at 657 (citing council for urological interests v. sebelius, 668 f.3d 404, 708 (d.c. cir. 2011)). 110 henry, supra note 9. 111 letter from john w. dietz, jr., (nov. 13, 2013) (on file with author). 832 indiana health law review vol. 12:2 spots, even though physician-owned hospitals comprise only 196 of the 3428 ranked hospitals in the nation.112 indiana orthopaedic hospital in particular is ranked eleventh in the country by the cms hospital value based purchasing program. by eliminating the ability of physician-owned hospitals to expand and therefore to compete on a level playing field with non-physician-owned hospitals, section 6001 of the aca negatively affects the quality of care, cost of care,113 and falsely accuses physician-owned hospitals of conflicts of interest. a. quality there are three ways quality is improved in physicianowned specialty hospitals: the hospitals are “focused factories,” the physician “knows best,” and the physician’s “name is on the door.”114 patient outcomes are improved in physician-owned specialty hospitals because the physicians and hospital staff are able to focus on a limited range of diagnoses and procedures.115 thirty-day risk-adjusted mortality rates are “significantly lower for specialty hospitals than for community hospitals.”116 furthermore, studies have shown that hip and knee replacement surgeries at orthopedic hospitals, such as indiana orthopaedic hospital, result in a 50% lower complication 112 id. 113 spencer harris & brad zarin, physician-owned hospitals, tex. pub. pol’y found. 1, 5 (2011), http://www.texaspolicy.com /center/health-care/reports/physician-owned-hospitals. 114 swanson, supra note 45, at 8 (physician-owned specialty hospitals are “focus factories” because the hospital has equipment, staff, and management dedicated and tailored to the particular specialty; the physician “knows best” because he has input in the design of the facility and procedures; and because the physician has his “name on the door” he has a greater interest in the hospital’s overall reputation. these three things imply high quality, low cost care.). 115 leslie greenwald et al., specialty versus community hospitals: referrals, quality, and community benefits, 25 health aff. 106, 112 (2006). 116 id. at 113; swanson, supra note 45, at 1 (physician-owned hospitals show evidence of significant mortality improvement, primarily for moderate severity patients). http://dx.doi.org/10.1377/hlthaff.25.1.106 2015 physician owned hospitals 833 rate than at community hospitals.117 the specialization of the physicians, nurses, and medical staffs at physicianowned specialty hospitals creates a team that is made up of experts in the hospital’s particular field.118 also, physicianowned specialty hospitals staff more nurses per bed than community hospitals.119 by employing experts in the specialty at every level of care, the hospital is best able to efficiently treat the patient and prevent any common complications that may arise from the procedure. 1. focus factories patients benefit from lower cost and better quality care created through physician innovation and specialized care. physician-owners are reimbursed for their extra effort of medical procedure innovation and hospital management roles with a portion of the value that each physician produces for the hospital. the focus on a limited range of services provided by physician-owned specialty hospitals has been shown to increase positive outcomes and decrease complications.120 in texas for example, when physicianowners of cardiac specialty hospitals treat patients in community hospitals the morality rate is significantly higher than the risk-adjusted in-hospital mortality rate at specialty hospitals.121 this shows that the specialization of the hospital and extra attention by the physician-owners and managers in implementing procedures, hiring staff, and purchasing equipment makes a difference in the quality of care provided. the physician is not the only person treating the patient; having the most qualified team and the safest hospital procedures clearly impacts the quality of care. opponents of physician-owned hospitals question the reliability of the risk-adjusted in-hospital morality rate 117 dietz, supra note 111. 118 herzlinger, supra note 60, at 3. 119 liam o’neill & arthur j. hartz, lower mortality rates at cardiac specialty hospitals traceable to healthier patients and to doctors’ performing more procedures, 31 health aff. 806, 807 (2012). 120 henry, supra note 9. 121 o’neill & hartz, supra note 119, at 806. http://dx.doi.org/10.1377/hlthaff.2011.0624 834 indiana health law review vol. 12:2 difference. while the patient outcomes of physician-owned hospitals appear to be better than those of community hospitals, opponents of physician-owned hospitals believe evidence of physicians choosing healthier patients and those with fewer co-morbidities can account for the differences in outcomes.122 peter cram found that the differences in riskadjusted outcomes were not significant once the study accounted for patient severity and hospital volume.123 however, in later studies when different risk-adjustment models are used the opposite conclusion is reached.124 critics also believe that physician-owned specialty hospitals create safety issues for patients.125 opponents of physician-owned hospitals claim that by offering a limited range of procedures, physician-owned specialty hospitals are not equipped to appropriately deal with complications.126 physicians have an ethical and legal duty to “do no harm” to their patients and a professional mandate to put their patient’s interests above the physician’s own interests, not to choose to operate in a facility because of the physician’s economic self-interest.127 if the facilities cannot adequately treat the patient, including any emergency conditions, then physician-owners referring to their owned facilities are not fulfilling the physicians’ duty to their patients, but instead are looking out only for their personal gain. issues arise for physician-owned specialty hospitals when the hospitals are not staffed with physicians at night or when the employees do not have the emergency training or the emergency equipment to deal with medical crises. in a medical crisis, the staff at the physician-owned hospitals may have to resort to calling 9-1-1 for help. opponents of physician-owned hospitals use stories of patients who have lost their lives at physician-owned specialty hospitals because the hospitals did not have the full services to 122 id. at 807. 123 id. 124 id. 125 poppitt, supra note 31, at 1. 126 greenwald et al., supra note 115, at 112. 127 perry, supra note 13, at 51. 2015 physician owned hospitals 835 combat emergency situations that arose during treatment to illustrate their point.128 most of the hospitals in these examples did not have physicians or trained emergency personnel on hand and had to resort to calling emergency medical services for transportation to the nearest general hospital, too late to save the patient’s life.129 this lack of emergency equipment and training can pose a significant problem for safety at physician-owned hospitals. some interpret the lower severity levels in physicianowned specialty hospitals as “cherry picking,” but the medpac report also argues that the lower severity levels could be considered to be a quality indicator.130 by focusing on a particular patient type, these hospitals can adequately treat patients with the best care.131 there are other reasons that could account for different patient severity levels too. the demographics and health characteristics in the community surrounding the hospital location may play a role. also, “optimal matching,” where “different hospitals may be better suited to treating different types of patients,” may affect a physician’s referral decision and therefore a hospital’s outcomes.132 an example of this would be a cardiac patient with a non-cardiac illness such as diabetes who would be best treated in a full-service community hospital as opposed to a specialized cardiac hospital. this patient may need treatment by multiple specialists, making a general hospital a better facility for the procedure. according to dr. john dietz, orthopedic surgeon and part owner of indiana orthopaedic hospital, the only reasons physicians practicing at indiana orthopaedic hospital would send a patient to another hospital are because the insurance will not cover treatment at indiana orthopaedic hospital, the patient wants to be treated at another 128 id. at 2-6. 129 id. 130 leavitt, supra note 28, at 61; see swanson, supra note 45, at 1 (“[t]here is no strong evidence of physician-owner cherry-picking of healthier patients. the distribution of patients across hospitals is primarily driven by physicians’ average preferences over hospitals.”). 131 leavitt, supra note 28, at 61-62. 132 swanson, supra note 45, at 2-3. 836 indiana health law review vol. 12:2 location, or the patient’s primary-care physician prefers another hospital.133 otherwise, all patients would be treated at indiana orthopaedic hospital. physician-owners have a preference for treating their patients at the hospital where the physicians have helped designed the facilities, procedures, and staff to be exactly what the physicians believe are best for their combined practice.134 2. the physician knows best physician-owned hospitals have proven to be more efficient and less bureaucratic than community hospitals.135 when physicians own the hospital in which they work, the physicians are able to design and operate the hospital in a way that overcomes the inadequacies the physicians experienced in community hospitals.136 in order to combat a dangerous complication of heart surgery, one specialty cardiology hospital developed a new standard protocol which reduced the occurrence of such complications by twothirds.137 this kind of innovation is less likely to happen at a large community hospital, so having smaller, more nimble physician-owned facilities is important to the overall market for testing new procedures to improve care. physician-owners in physician-owned specialty hospitals also govern the hospital, eliminating the issue of traditional hospital administration making unilateral decisions that the physicians feel harm productivity and patient care.138 with fewer layers of bureaucracy, changes can be made in physician-owned hospitals more quickly than at community hospitals, thus making physician-owned hospitals more responsive.139 133 hogberg ban, supra note 65. 134 see swanson, supra note 45, at 35. 135 dietz, supra note 111. 136 herzlinger, supra note 60, at 76. 137 id. 138 id. at 77. 139 henry, supra note 9. 2015 physician owned hospitals 837 3. name on the door when physicians own a portion of the hospital where they are employed, the physicians have a commitment to and pride in the organization that is not replicated in community hospitals.140 according to the physician hospitals of america’s former executive director, molly sandvig, physicians opened their own hospitals “because they want[ed] to do something right by their patients. they want[ed] to be able to control health care, and they [did not] feel like they [could] do that at community facilities any more.”141 by having an interest in the owning and operating of the hospital, physicians have a “sense of responsibility for the outcomes.”142 physician-owners must be concerned with the mortality and morbidity outcomes of their hospital in addition to their personal procedure outcomes. this concern give them an extra reason to make sure that they, the other physicians practicing at the facility, and their hospital staff are the most qualified care providers and that the physician-owned hospital’s processes ensure the most safe and efficient patient care possible. physicians should be allowed and empowered to create better quality, less expensive care. “physician-owned hospitals provide high-quality patient care and increase competition and choice in the marketplace -those should be the hallmarks against which these hospitals are judged, said then-ama president j. james rohack, md.”143 “restricting physician-owned hospitals is counter to what we are working to achieve: a better health care system for patients and physicians.”144 data from the research study conducted by leslie greenwald shows that there is little difference in the referral patterns of physician-owners and non-owners.145 this data would suggest that the referring physicians are 140 greenwald et al., supra note 115, at 117. 141 silva, supra note 43. 142 henry, supra note 9. 143 silva, supra note 43. 144 id. 145 greenwald et al., supra note 115, at 112. 838 indiana health law review vol. 12:2 primarily concerned with the specialization of the hospital and not the ownership when choosing a facility to refer their patients.146 the medpac report postulated that “[a] hospital that accepts patients that it cannot properly treat may not exhibit good quality healthcare.”147 a physician who has taken an oath to “do no harm” is under an obligation to make the decision of where to treat in the best interest of his patient. referring a patient to a facility that cannot properly treat is not in the best interest of the patient and therefore is not something a physician would do. the aca’s hospital value based purchasing program rewards hospitals for providing quality care to patients.148 hospital quality is measured using metrics for hospital process and patient satisfaction.149 at the end of 2012, hhs announced the first set of hospital bonuses and penalties for the hospital value based purchasing program. nine of the top ten hospitals and forty-eight of the top one hundred hospitals ranked by hhs were physician-owned hospitals.150 these rankings back up the hhs findings in its 2005 study that physician-owned specialty hospitals “provide a high level of quality of care.”151 this provides proof, from the very administration limiting physicianowned hospital growth, that physician-owned hospitals have more focus on patient care and have better processes due to smaller administrations and fewer bureaucratic layers to get to quality at the patient bedside. 146 id. 147 leavitt, supra note 28, at 61. 148 david hogberg, op-ed: congress should repeal limits on new doctor-owned hospitals, wash. examiner (mar. 6, 2013, 12:00 am), http://washingtonexaminer.com/op-ed-congress-should-repeal-limits-onnew-doctor-owned-hospitals/article/2523441 [hereinafter hogberg repeal]. 149 id. 150 id. 151 leavitt, supra note 28, at 62. 2015 physician owned hospitals 839 b. cost health care costs made up 17.1% of the united states gdp in 2013, a continuation of the health care cost growth trend.152 these costs put an enormous strain on federal and state government budgets as well as individual families. part of the purpose of the aca was to remedy these cost increases. however, instead of slowing the growth of health care costs, the physician-owned hospital provisions of the aca actually increase costs by discouraging community hospitals from increasing cost efficiency, creating sunk costs for some physician-owned hospitals, and limiting community benefits from the taxes paid by physician-owned hospitals. 1. patient costs a patient’s fees provide two streams of revenue.153 one goes to the physician as a professional fee for his service. the other is a facility fee that is paid to the hospital for use of the operating room, hospital bed, nursing staff, and other items provided by the hospital. the hospital’s facility fee eclipses the physician’s professional fee and makes up the majority of the cost to the patient.154 opponents of physician-owned hospitals believe that physician-owned hospitals contribute to the health care cost problem. the opponents claim that the physician-owned hospitals “cherry-pick” the most lucrative patients by referring the healthier patients or the ones needing more profitable procedures to the physician’s owned facility for financial gain while sending less lucrative patients to community hospitals.155 physician-owners share in the profits of the hospital, giving the physicians a financial incentive to increase profits. by referring the easier 152 health expenditure, total (% of gdp), world bank, http://data.worldbank.org/indicator/sh.xpd.totl.zs (last visited apr. 30, 2015). 153 whelan, supra note 9. 154 id. 155 leavitt, supra note 28, at 2. 840 indiana health law review vol. 12:2 patients to physician-owned facilities, the physicians can increase the net income of the hospital which is then distributed to the owners or reinvested back into the hospital.156 opponents also argue that compensation schemes for physicians can incentivize the physicians to over-utilize hospital diagnostic tests, services, and procedures. many believe that without some checks on the growth of specialty hospitals, community hospitals will find large declines in profit margins.157 the 2005 medpac report revealed that “physicianowned specialty hospitals do treat a higher percentage of patients who are less sick, and therefore less costly and more profitable, than patients receiving similar treatments at general hospitals.”158 according to the 2005 medpac report, 1%-2% of patients admitted to specialty hospitals have medicaid compared to 15% at community hospitals.159 the study also found that most of the patients treated at physician-owned specialty hospitals come from the potential patient pool for the community hospitals, taking market share away from the community hospitals.160 liam o’neill and arthur j. hartz found that in texas between 2004 and 2007 the “risk-adjusted in-hospital mortality rate for patients treated at specialty hospitals in the state was significantly below the rate for all hospitals in the state . . . ” but “the rate was significantly higher when physicians who owned cardiac specialty hospitals treated patients in general hospitals . . . ”161 this could indicate that physician-owners are referring healthier patients to the physician-owned facilities. one study that examined 156 id. 157 perry, supra note 13, at 34. 158 id. 159 orthopedic specialty hospitals promise better care, but may face ethical dilemmas, orthopedics today (july 2012), http://www.healio.com/orthopedics/business-oforthopedics/news/print/orthopedics-today/%7b5e3b9ade-c0a4-46c59493-f4459bf57c49%7d/orthopedic-specialty-hospitals-promise-bettercare-but-may-face-ethical-dilemmas [hereinafter orthopedic ethical dilemmas]. 160 perry, supra note 13, at 34. 161 o’neill & hartz, supra note 119, at 806. 2015 physician owned hospitals 841 referral patterns of physician-owners found that physicianowners referred healthier and more profitable patients to the hospitals the physicians owned.162 by taking away the lucrative patients from the community hospital, the community hospitals lose revenue that the hospitals would use to fund unprofitable services like emergency rooms or burn units. while physicians may have an interest in increasing the profits of the hospital, profits are not likely to be physicians’ first priority. most individual physicians own small proportions of the physician-owned hospitals so each physician’s share of the hospital profits are small as well.163 as previously stated in this note, each investor receives a portion of the profits proportional to its ownership position. the investors must also rely on the other physicians with privileges at the physician-owned hospital to provide value for the hospital because all the physicians share in the profits. generally, each physician receives a share of all the profits of all the patients, not just his own.164 also, opening a hospital takes a large initial capital expenditure and recouping that amount takes several years. this means that the hospitals will not be returning profits to investors for a few years after beginning operation. after waiting a few years for income from the investment and receiving such a small portion, a physician would not be motivated to cherry pick patients or over-utilize services. 2. sunk costs for physician owned hospitals proponents of physician-owned hospitals claim that the aca’s requirements to meet an exception are so arduous that the requirements are impossible to meet.165 texas spine and joint hospital had a $37 million project to add three operating rooms, three procedure rooms, and twenty beds to its facility.166 this expansion would have doubled 162 id. at 807. 163 argue, supra note 15, at 350. 164 id. 165 henry, supra note 9. 166 silva, supra note 43. 842 indiana health law review vol. 12:2 capacity and provided about 540 new jobs for the local community.167 in a time of a suffering job market, these jobs would have been a great boost to the local economy. in loma linda, california, physician investors were working with the local university’s medical center to develop a 110 bed tower and medical office building as part of a $250 million project.168 the building would have provided care to areas underserved in the community, but the new building was abandoned because the new facility would not have had medicare certification by the deadline.169 dr. john piconi, retired urologist and lead of the physician-investors in the project, said “we started this project four years ago when there was no law prohibiting us from doing [it].”170 indiana orthopaedic hospital’s investors had put $27 million into a new building with three rooms for outpatient surgery that was three-quarters finished and was almost unable to be used.171 these expansions take years to plan and complete and were all started long before discussions began on the aca. the capital loss to the hospitals and the loss of availability of quality care to the communities when the hospitals had no warning of the existence of or extent of the regulations is reprehensible. these entrepreneurial physician groups are not the only ones affected by the changes to the stark law. over sixty hospitals under development before the passing of the aca were essentially destroyed by section 6001.172 “[a]t a time when the government is supposedly attempting to increase access to care, it has chosen to stop the growth of many of the best hospitals in the country,” said molly sandvig, former pha executive director.173 while politicians were promising more “shovel ready” jobs for struggling communities, the same politicians were actively prohibiting the creation of construction, medical, custodial, 167 id. 168 id. 169 id. 170 id. 171 hogberg ban, supra note 65. 172 silva, supra note 43. 173 id. 2015 physician owned hospitals 843 administrative, and other jobs that would definitely materialize because of these hospital creations and expansions. the physician-owned hospitals that are grandfathered under the law and still able to operate are prohibited from expanding, even in cases where the physician-owned hospitals have spent considerable amounts on expansions that were planned long before aca was passed.174 this is a huge waste of capital resources for the hospitals. had the hospitals been given sufficient warning, the funds the physicians expended on hospital expansion projects that have had to be cancelled could have been used instead to update equipment, provide uncompensated care to the uninsured, or other productive uses. 3. competition for patients physician-owned hospitals also compete with community hospitals for patient market share. in december 1996, st. luke’s, an ambulatory surgery center, opened.175 st. luke’s is owned by physicians on the staff of north oaks, the only full-service acute care hospital in hammond, louisiana.176 while north oaks inpatient procedure volumes stayed about the same, its outpatient surgery volume dropped. according to the authors, st. luke’s outpatient volume rose “sharply” in 1997, while north oaks saw a corresponding drop during the same time period.177 the authors argue that the threat to community hospitals is due to competition lowering prices in the market and a loss of patient volume in the community hospital.178 while on the surface it looks to be procompetitive to open a new hospital and expand 174 see physician hosps. of am. v. sebilius, 691 f.3d 649, 652 (5th cir. 2012); loopholes, supra note 1; silva, supra note 43. 175 william j. lynk & carina s. longley, the effect of physicianowned surgicenters on hospital outpatient surgery, 21 health aff. 215, 216 (2002). 176 id. 177 id.; see argue, supra note 15, at 352 (“[t]he increase in specialty facility patient volume mirrors the decrease in patient volume at the competing hospital, at least initially.”). 178 lynk & longley, supra note 175, at 221. http://dx.doi.org/10.1377/hlthaff.21.4.215 844 indiana health law review vol. 12:2 overall market output, the authors believe that the competition effects are clouded by physician-owners financial incentives.179 what the authors failed to point out is that any increase from a baseline of 0 surgeries will appear to be a sharp increase in a market with a fixed number of patients. while north oaks experienced a temporary drop in outpatient surgical procedures in 1997, by mid-1998 its volume returned to the pre-st. luke’s level.180 in exhibit 1, the hospitals received corresponding increases and decreases in surgical volumes during 1997.181 in 1999 st. luke’s experienced an increase in surgical procedures, but the decrease that north oakes experienced was much less than st. luke’s increase. this shows that there were plenty of patients for both hospitals to treat. when a new competitor enters the marketplace, some customers will move to the new competitor from the old competitor. however, since the overall volume of outpatient surgical procedures continues to increase, there is clearly a large enough population of patients to support both hospitals. the number of cases referred to north oakes by physician-owners decreased after the opening of st. luke’s. as discussed elsewhere in this note, physician-owners opened their own hospitals and refer patients to their owned facilities because the physicians believe that treatment at the hospital that they helped design and run is in the best interest of their patients. for a physician-owner to refer his patients to his owned facility is not an unusual or unreasonable occurrence because he believes that his facility provides the best care. he helped chose the nursing and medical staffs, helped pick out the equipment, and had input on the procedures used in the hospital. if he did not believe that his hospital was the best location for treatment, the physician would not have taken the financial risk to invest in it. 4. community benefits 179 id. 180 id. at 216. 181 id. 2015 physician owned hospitals 845 while the medpac report discussed earlier found that a smaller percentage of medicaid patients are treated at specialty hospitals, the medpac report found no evidence that specialty hospitals are putting community hospitals out of business.182 specialty hospitals tend to make more in profit overall, but there is not a significant difference in the profitability of community hospitals that compete with specialty hospitals and those that do not.183 competition from specialty hospitals actually encouraged and allowed community hospitals to improve hospital services and become more efficient.184 with the aca providing insurance for an estimated 30 million people, the ability of physician-owned hospitals to provide efficient and low cost quality health care should not be stifled.185 the claim by opponents that, by treating the healthier patients, physician-owned hospitals make more profit per patient than community hospitals is inaccurate. hospitals are reimbursed by medicare based upon diagnosis related groups (“drgs”).186 using risk adjustments, patients with similar risks are grouped in one drg.187 more severe health conditions, called co-morbid conditions or major comorbid conditions, qualify a patient’s care for greater medicare reimbursement.188 the cms value based purchasing database for indianapolis-area hospitals performing the procedures commonly performed at indiana orthopaedic hospital shows how medicare charges vary between hospitals within the same drg. for example, for a hip and knee replacement, which has the most standardized technique of all drgs reported, the medicare certified charges to the average non-physician owned hospital in the indianapolis-area is 56% higher than the indiana orthopaedic hospital.189 the excess charges for a procedure 182 orthopedic ethical dilemmas, supra note 159. 183 medpac report, supra note 42, at 15. 184 orthopedic ethical dilemmas, supra note 159. 185 henry, supra note 9. 186 dietz, supra note 111. 187 id. 188 id. 189 id. 846 indiana health law review vol. 12:2 with a standardized technique are due in part to inefficiencies in the hospitals.190 dr. dietz said “[q]uite contrary to the provisions of obamacare, we should be promoting the model of physician-ownership as an opportunity to create high-quality, highly efficient hospitals where medicare recipients can get the best possible care at the least cost.”191 a hospital with better staffing, organization, and less bureaucracy can complete surgeries up to 50% faster, thus decreasing the inefficiency costs.192 dr. dietz says that the cms data reflects the “wide variation in efficiency between hospitals in our hrr as well as the high degree of efficiency at [indiana orthopaedic hospital].”193 if the five reported drgs were performed at indiana orthopaedic hospital, or a hospital with similar efficiencies, medicare would have saved nearly $15 million in payments in one hrr in one year and avoided the extra costs of complications by benefitting from the 50% lower complication rate.194 the cms data support the idea that physician-owned hospitals should be allowed to open, exist, and expand to challenge community hospitals to improve efficiencies and provide better quality at lower cost. community hospitals have used their deep pockets to lobby representatives in the united states congress to pass laws aimed at squelching their competitors, the physicianowned hospitals, and to award tax-exemptions.195 the community hospitals claim to need the tax exemptions in order to provide care for the poor and uninsured.196 however, these same hospitals charge uninsured patients prices much greater than those charged to insured patients.197 the monies saved through these tax exemptions are not being passed onto the uninsured through lower hospital prices. 190 id. 191 hogberg repeal, supra note 149. 192 dietz, supra note 111. 193 id. 194 id. 195 herzlinger, supra note 60, at 18. 196 id. at 4. 197 id. at 2. 2015 physician owned hospitals 847 one hospital ceo argued before congress that a small physician-owned specialty hospital was limiting the ability of his hospital chain to provide free care for the poor and sick by siphoning off his hospitals’ most profitable patients.198 yet at the same time his hospital chain was allegedly struggling, the hospital chain still earned $26 million in profits and held $50 million in cash and liquid investments, even after all charitable actions were accounted for.199 in fact, very little of the available funds were used to help patients unable to pay their hospital bills, and the hospital actually decreased its charitable care as profits increased.200 community hospitals have used stated philanthropic intentions to persuade the government to enact laws in their favor. yet, this example of a hospital chain holding onto millions in cash while decreasing charitable care seems to show the hypocrisy of the community hospital arguments. when indiana university health began buying the physician-owners out of its hospitals, the hospital group also announced plans to convert the hospitals to not-forprofits.201 non-profit hospitals do not have to pay income taxes, usually are not required to pay sales and real estate taxes, and are able to borrow using tax-subsidized municipal debt.202 u.s. congressional staff members estimated that tax subsidies lowered nonprofit expenses by $13 billion in 2002.203 by becoming not-for-profits, the local communities will lose the tax income from the facilities to use for fire and police departments, schools, and roads. physician-owned hospitals on the other hand, pay income, property, and sales taxes and cannot take advantage of tax-subsidies, thus providing funds to the community for other municipal endeavors. physicianowned hospitals concede that they provide lower levels of uncompensated care than community hospitals but argue 198 id. at 4. 199 id. at 5. 200 id. 201 iu health, supra note 7. 202 herzlinger, supra note 60, at 68. 203 id. 848 indiana health law review vol. 12:2 that the taxes that the physician-owned hospitals pay offset the smaller proportion of uncompensated care.204 the 2005 hhs report defines “net community benefit” as the sum of uncompensated care costs and tax payments.205 in the study, cardiac hospitals had a net community benefit of 3.74% of total operating revenue (“tor”), orthopedic & surgery hospitals had a net community benefit of 7.23% of tor, while not-for-profit had a net community benefit of 0.87% of tor.206 the report even went so far as to include medicaid shortfalls to adjust the uncompensated care numbers for community hospitals up to 2.27% of tor.207 the medicaid shortfall accounts for the fact that medicaid payments to hospitals were about 4.1% lower than costs, which is about 1.4% of total revenue on average nationally.208 even after including the medicaid shortfall, the physician-owned hospitals still provided a greater net community than community hospitals.209 c. conflict of interest community hospitals, through groups like the american hospital association and the american federation of hospitals, lobbied for limits on the expansion of physicianowned hospitals.210 in 2006, the american hospital association, which represents non-profit hospitals, donated $1.8 million to federal candidates.211 community hospitals have argued for years that physician-owners use selfreferral to refer healthier, more profitable patients to physician-owned facilities and leave sicker, costlier patients for community hospitals. limiting growth, capping physician ownership, ending some stark law exceptions for self-referral bans, and requiring disclosures of physician ownership of facilities and 204 leavitt, supra note 28, at 2-3. 205 id. at 55. 206 id. at 58. 207 id. at 59. 208 id. 209 id. 210 hogberg repeal, supra note 148. 211 herzlinger, supra note 60, at 64. 2015 physician owned hospitals 849 potential conflicts of interest when referring patients to those facilities were ideas encouraged by the “big hospital” lobby to decrease competition from physician-owned hospitals.212 sandvig believes that critics of physicianowned hospitals are worried that the more efficient way of doing things will push community hospitals toward obscurity. “they see a new model that works very well, that’s high-quality, low-cost, better efficiency. it’s a case of an innovation that they don’t want to have to match,” she stated. 213 community hospitals argue that physician-owned hospitals operate with an inherent conflict of interest, treat the most profitable patients, and place strains on the finances of community hospitals, which in turn reduces key services in those community hospitals.214 in the absence of an ownership interest, physicians will consider many different variables in choosing a facility for a patient like the best interests of the patient and convenience.215 when hospital ownership interest is added, a physician has the added variable of an economic interest.216 this conflict of interest may breach a physician’s fiduciary duty to his patient. community hospitals have a difficult time competing with physician-owned hospitals because federal regulations prohibit the community hospitals from offering anything of value to physicians for referrals.217 community hospitals also still must provide emergency or trauma services and charity care which provide little to no income to the hospital.218 if this is true, community hospitals are losing out on revenue because physician-owners are referring the profitable patients to physician-owned facilities, and referring the unprofitable or less profitable patients to the community hospitals, to bolster the physician-owned hospital profits and thus the physician 212 silva, supra note 43. 213 id. 214 id. 215 lynk & longley, supra note 175, at 215 216 id. 217 terry, supra note 6. 218 id. 850 indiana health law review vol. 12:2 owner’s income. eventually community hospitals will be left with little to no funds to provide the emergency and charitable services that americans have come to expect hospitals to provide. along with an ownership interest in any business (including hospitals) comes a share of that business’s profits. critics of physician-owned hospitals claim that physicians have a “financial incentive to refer their least costly and most healthy [] patients to the facility in which they have an ownership interest, while choosing to operate on their sicker and more complex cases in the general hospital, where the costs of lengthy recuperation could be passed on and an emergency room would stand ready in the event of an emergency.”219 community hospital supporters believe that referring healthier patients to the hospital in which the physician has an ownership interest takes funds away from the community hospital that are normally used to offset the cost of unprofitable procedures and that this action increases health care costs for everyone.220 in the traditional physician/hospital relationship, the physician sells his services and the hospital sells its facilities, complementing each other.221 however, the relationship is put off balance when the physician has a personal financial interest in a facility that competes with the hospital in which the physician-owner works.222 when a physician-owner refers a patient to the hospital he owns he receives financial returns in two ways: once for performing the procedure and once for his portion of the hospital’s fee.223 this gives physician-owners a greater incentive to refer patients to the facility than non-physicianowners.224 patients who may not receive any benefit could be put through expensive, unnecessary procedures if there is a strong financial benefit for the physician-owner.225 219 perry, supra note 13, at 32. 220 terry, supra note 6. 221 lynk & longley, supra note 175, at 215 222 id. 223 id. 224 id. at 220. 225 id. 2015 physician owned hospitals 851 dr. arnold s. relman, professor at harvard medical school and editor-in-chief of the new england journal of medicine, is quoted in marc rodwin’s book medicine, money and morals: physicians’ conflicts of interest saying “medical care has become a competitive, revenue-seeking industry in which many physicians have an economic interest that goes beyond their personal services. this development undoubtedly affects many of the decisions doctors make, and it certainly adds to the cost of medical care.”226 rodwin testified about problems created by inappropriate physician self-referrals before the ways and means health subcommittee in 1993.227 summarized his points were that physician conflicts of interest have existed for over a hundred years; doctors are not subject the same conflict of interest regulations and fiduciary standards as other professions; currently the laws governing physician self-referral are disconnectedly and incompletely pieced together; and the current medical payment system has created the health care spending problem and encouraged corrupt economic incentives for physicians.228 however, if physicians were referring patients for unnecessary procedures insurance companies and medical malpractice attorneys would take notice.229 instead, insurance companies are directing patients to physicianowned hospitals, such as indiana orthopaedic hospital, for the physician-owned hospitals’ cost efficiencies and medical malpractice attorneys are not filing claims.230 because insurance companies are directing patients toward the less costly, better quality physician-owned hospitals and medical malpractice attorneys are not targeting these physicianowned hospitals, the evidence appears to show that there are no issues concerning physicians recommending unnecessary procedures. physician hospitals of america president and senior executive officer of the kansas city orthopedic institute in leawood, kansas, a physician 226 sutton, supra note 18, at 22. 227 id. 228 id. 229 henry, supra note 9. 230 id. 852 indiana health law review vol. 12:2 owned facility, paul kerens says “physician owners started getting into the hospital business to provide better patient care and provide efficiencies of care. they are not in it for the money.”231 the average physician invested in a physician-owned hospital owns less than 2 percent of the hospital.232 the amount of income that would come from each individual patient referred by a physician-owner is so trivial that income generated from a referred patient would not be a major factor in determining where to send a patient for a procedure. the 2005 hhs report concluded that referral patterns of owner-physicians are consistent with referral patterns of non-owner physicians.233 the study found that although physician-owners had high percentages of referrals to the facilities in which the physicians have an ownership interest, the numbers were not surprising because the physician-owners had “an established clinical rapport and favorable working relationship with the facility in which they have an ownership interest.”234 physicians are more likely to refer their patients to the facility with which the physicians have developed a “primary relationship,”235 which is not necessarily an ownership interest. also, the report could not find any regular patterns of physicianowners referring patients to their owned-facilities compared to their peers.236 the community hospitals may be seen to also have a conflict. in the past, physicians have been self-employed, independent contractors for the hospitals.237 increasingly physicians are becoming salaried employees of community hospitals instead of independent contractors with privileges to practice in the community hospitals. regina herzinger points out the fact that by hiring physicians as salaried employees, hospitals are taking advantage of the vertical 231 id. 232 perry, supra note 13, at 30. 233 leavitt, supra note 28, at 61. 234 id. 235 id. 236 id. 237 herzlinger, supra note 60, at 69. 2015 physician owned hospitals 853 integration strategy.238 this strategy involves owning the sources of your customers and your suppliers.239 by hiring physicians as hospital employees, community hospitals are ensuring that the physicians will refer patients to the employing hospital. 240 the hospital will receive the facility fee from the patient’s payment and be able to control how much the physician receives as salary from his patient’s payments.241 an independent physician would refer patients to the hospital that he believes would best serve the patient’s needs,242 but a physician-employee would be required to refer his patients to the hospital which employs him. in enacting section 6001 of the aca, congress has not “identified any data that suggests that physicians who invest in hospitals have a greater conflict of interest when it comes to referring patients than physicians who are employed by a hospital.”243 v. conclusion physician-owned hospitals have proven themselves to be a cost efficient way to provide high-quality health care to patients. in an era where health care costs are rising quickly, this proven method of medical care will help keep costs down more so than any alternative. the federal government recently rewarded a significantly high proportion of physician-owned hospitals for the hospital’s ability to provide the kind of care that the aca claims to encourage. the model created by the physicians who started and continue to run physician-owned hospitals is one that can and should be duplicated at all hospitals across the country. these hospitals set the bar high for other hospitals. the big hospital lobbying group simply does not want to compete with physician owned hospitals, so community hospital supporters have decided to try to use 238 id. at 70. 239 id. 240 id. 241 whelan, supra note 9. 242 herzlinger, supra note 60, at 70. 243 sutton, supra note 18, at 32-33. 854 indiana health law review vol. 12:2 government regulation to eliminate the competition. any conflicts of interest or overutilization claims by opponents of physician-owned hospitals are offset by the absence of malpractice claims and the continuance of insurance companies to refer patients for treatment at physicianowned facilities. for these reasons, section 6001 of the aca should be completely repealed allowing physicians to invest in hospitals and to grow them as the local communities require. i. introduction a. the issue b. roadmap ii. background a. federal anti-kickback statute b. stark law c. medicare modernization act iii. implementation of the aca a. aca changes 1. disclosures 2. bona fide investment b. exceptions to the law c. physician hospitals of america v. sebelius iv. analysis a. quality 1. focus factories 2. the physician knows best 3. name on the door b. cost 1. patient costs 2. sunk costs for physician owned hospitals 3. competition for patients 4. community benefits c. conflict of interest v. conclusion setting the stage: enhancing understanding of bioethical challenges with theatre setting the stage: enhancing understanding of bioethical challenges with theatre karen h. rothenberg* i. setting the stage.................................. 3 ii. whose life is it anyway ..................... ...... 5 iii. the normal heart ........................ ...... 11 iv. the twilight of the golds ....................... 16 v. next to normal ............................. ..... 21 vi. conclusion .............................. ....... 26 theatre provides a dynamic platform to reflect upon the ethical, legal and social implications of medical innovations and the powerful impact on personal and professional relationships. from the time of the ancient greeks, the drama of these complex interactions on stage has brought to life many emotional challenges-generating hope, fear, and conflicts surrounding identity. over the last several years, my colleague lynn bush and i have discovered a broad spectrum of plays that we have explored and analyzed in more detail as a creative approach j.d., m.p.a., marjorie cook professor of law and founding director, law and health care program, university of maryland francis king carey school of law and visiting professor, johns hopkins berman institute of bioethics, johns hopkins university. for the 2013-14 academic year, professor rothenberg is serving at the national institutes of health as senior advisor on genomics and society to the director, national human genome research institute, and visiting scholar, department of bioethics, clinical center. professor rothenberg was the 2013 recipient of the mcdonald-merrillketcham memorial lectureship and award for excellence in law and medicine. setting the stage is an adaptation of the keynote speech by the same name that professor rothenberg delivered at the mcdonald merrill ketcham award lecture, sponsored by the hall center for law and health, indiana university robert h. mckinney school of law, indianapolis, indiana, on february 7, 2013. indiana health law review to reflect on the role that legal and bioethical principles can play to mediate controversial issues in society.' this work has evolved, in part, from years of trying to figure out how best to engage folks with differing views and perspectives on complex ethical and societal issues. from my experience, the tools used in bioethics and the law have not been enough to bring the issues to life. as science moves forward at an ever-increasing pace, it becomes more critical to develop creative approaches to better understand the bioethical challenges and to place them in historical and societal context.2 with these goals in mind, i set the stage by exploring the last four to five decades of theatre, which coincide with the evolution of the formal discipline of bioethics and the field of medical humanities. selected excerpts from four plays, one from each decade beginning with the 1970s and through the beginning of the twenty-first century, are highlighted to reflect the ethical and legal context of their eras. the analysis of the themes that reoccur over time cover one hot topic per decade, each revealing significant ethical challenges for us to ponder. for the 1970s, we explore whose life is it anyway.8 and its focus on the "right to die" and "death with dignity,"4 1 karen h. rothenberg & lynn w. bush, the drama of dna: narrative genomics (forthcoming march 2014) (final book manuscript, on file with authors and oxford university press) [hereinafter rothenberg and bush, drama of dna]; karen h. rothenberg & lynn w. bush, manipulating fate: medical innovations, ethical implications, theatrical illuminations, 13 hous. j. health l. & pol'y 1 (2012) [hereinafter rothenberg and bush, manipulating fate]; karen h. rothenberg & lynn w. bush, genes and plays: bringing elsi issues to life, 14 genetics in med. 274 (2012); karen h. rothenberg, from eugenics to the 'new" genetics: "the play's the thing," 79 fordham l. rev. 407 (2010) [hereinafter rothenberg, "new" genetics]. substantial portions of this article contain direct quotations and substantive references from manpulating fate (selected citations and quotations omitted). in addition to manipulating fate, other portions of this article are adapted from the publications noted above and are referenced as applicable. 2 rothenberg & bush, drama of dna, supra note 1, pt. iii, ch. 6, at 3. 3 brian clark, whose life is it anyway? (dramatic publishing 1974) (1972). vol. 11:12 setting the stage followed by the normal heart,5 an editorial drama about the emergence of, and response to, the aids epidemic in the 1980s. the ethical, legal, and social implications of new genomic technologies are examined in the 1990s play the twilight of the golds,6 followed by next to norma,7 a 2009 musical dealing with mental illness-a recurrent theme in theatre-and an ongoing challenge for medicine and our society. i. setting the stage the formalization of bioethics as a discipline intensified scrutiny of the interplay among science, policy, and the public.8 by the late 1960s and early 1970s, we gained much perspective on both the benefits and threats of science and technology existing during and after world war ii. the double helix was discovered, which opened up the promise for a "new genetics,"9 the birth control pill was prescribed to 4 see generally rothenberg & bush, manipulating fate, supra note 1, at 27-29; see also alan meisel & kathy cerminara, the right to die: the law of end-of-life decisionmaking, §§ 2.01, 4.01-4.01[c] (3d ed. 2004 & supp. 2011). 5 larry kramer, the normal heart, in the normal heart and the destiny of me: two plays by larry kramer 1 (2000); see generally rothenberg & bush, manipulating fate, supra note 1, at 4042. 6 jonathan tolins, the twilight of the golds: a play in two acts (1992); see generally rothenberg & bush, manipulating fate, supra note 1, at 49-51. 7 brian yorkey, next to normal 32 (2010); see generally rothenberg & bush, manipulating fate, supra note 1, at 70-72. 8 tom l. beauchamp & james f. childress, principles of biomedical ethics 8-9 (6th ed. 2009); ruth r. faden et al., a history and theory of informed consent 92, 96 (1986); albert r. jonsen, the birth of bioethics (1998); david j. rothman, strangers at the bedside: a history of how law and bioethics transformed medical decision making 247-62 (walter de gruyter, 2d paperback ed. 2003) (1991). 9 rothenberg, 'new" genetics, supra note 1, at 410, 422; see also rothenberg & bush, drama of dna, supra note 1, pt. iii, ch. 6, at 5; aaron klug, the discovery of the dna double helix, 335 j. molecular biology 3 (2004). 2014 3 indiana health law review millions of women,10 livers and hearts had been transplanted along with the kidneys, the definition of death was debated, and a uniform anatomical gift act was drafted. this all occurred while the civil rights movement was changing our society forever.1 1 it was a time to challenge authority and the government on so many fronts. in 1972, the research abuses of the federally sponsored tuskegee syphilis study would make national news with calls for sweeping change about how to ensure the ethical conduct of research in our country.12 that same year, the case canterbury v. spence affirmed patient autonomy to make medical decisions and spelled out the parameters of informed consent.13 overall, as medical interventions became technologically more complex, the new field of bioethics was framing a number of fundamental questions for society to consider: is the extension of life beneficial if the individual experiences diminished consciousness or pain? what is the benefit? what is the harm? who should live and who should die, and who decides? when is it ethical to consider the allocation of scarce resources? how should technology be used to manipulate our fate? what impact would such interventions have on our humanity? what does it mean to be normal and how does our society embrace difference? 14 these and other medical and ethical challenges presented us with opportunities to evaluate how best to analyze the issues at stake-principles of bioethics and law 10 see john a. mccracken, reflections on the 50th anniversary of the birth control pill, 83 biology reprod. 684 (2010); see also jonsen, supra note 8, at 12 (summarizing the rapid advances in medical therapies throughout the course of the twentieth century). 11 see rothenberg, 'new" genetics, supra note 1, at 422-23. 12 see generally tuskegee's truths: rethinking the tuskegee syphilis study (susan reverby ed., 2000); tuskegee syphilis study legacy committee, final report of the tuskegee syphilis study legacy committee (1996), available at http://www.hsl.virginia.edu/ historical/medical-history/badblood/. 13 464 f.2d 772, 783-85 (d.c. cir. 1972); see generally beauchamp & childress, supra note 8. 14 rothenberg & bush, manioulating fate, supra note 1, at 59. 4 vol. 11:1 setting the stage would establish respect for persons as a strong value that was grounded on the dignity of the human being, the power of choice and control, and the autonomy of individuals to make their own medical decisions and control the course of their futures. underlying this autonomy would be the assumption that the individual had the mental capacity to make such decisions. the traditions of professionalism and "doctor knows best" were being reexamined. the principles of beneficence-do what would be best for the patient-and non-maleficence-do no harm-had to find their places in the ethical calculus. finally, concerns for justice were also to be evaluated in the context of ethical care-along with other questions of personal responsibility, cultural competencies, and interprofessional dynamics. while ethical principles help define issues and provide tools for problem-solving, the law is often called upon in the end to solve, or at least rule, on the issue at stake. 15 ii. whose life is it anyway? it is this relationship between ethical principles and the law that is examined in the first play, which was written at a time when legal and ethical foundations of the "right to die" were beginning to evolve for both those patients who had capacity and those who may have needed others to decide on their behalf.16 in fact, brian clark's whose life is it anyway? had a significant role in heightening public awareness on who decides how and when a patient may die, especially given the realities of the power dichotomy in medicine.17 the answer to "whose life is it?" is 15 see generally beauchamp & childress, supra note 8. 16 see alan meisel & kathy cerminara, the right to die: the law of end-of-life decisionmaking §§ 2.01, 4.01-4.01[c] (3d ed. supp. 2011). 17 alexander m. capron, foreword to jay katz, the silent world of doctor and patient, at xxii-xxiii (johns hopkins press ed., johns hopkins univ. press 2002) (1984); faden et al., supra note 8, at 17; peter g. filene, in the arms of others: a cultural history of the right-to-die in america at xiv-xv, 8-9, 219 (1998); charles fried, 2014 5 indiana health law review clear from the playwright's perspective: it is the patient's. first written as a play for british television in 1972, it premiered on stage in london in 1978 and a year later on broadway, followed by a film version in 1981. the protagonist, ken harrison, is a young sculptor who was permanently paralyzed from the neck down in an auto accident. although ken arrived at the hospital in critical condition, dr. emerson and his colleagues stabilized ken to his current state relying in part on advances in technology, yet ken decides he no longer wants to live. unable to physically control his fate, ken is at the mercy of others to enable him to die. he declares to his medical social worker, mrs. boyle: ken: go and convince dr. frankenstein that he has successfully made his monster and he can now let it go.... i really have absolutely no desire at all to be the object of scientific virtuosity. i have thought things over very carefully. i do have plenty of time for thinking and i have decided that i do not want to go on living with so much effort for so little result.18 mrs. boyle: we can't just stop treatment, just like that. . it's the job of the hospital to save life, not to lose it.... it's not unusual, you know, for people injured as you have been, to suffer with this depression for a considerable time before they begin to see that a life is possible.19 in fact, dr. emerson, who saved ken's life, now questions ken's mental state and moves to take steps to use the mental health act to retain ken. highlighting the interprofessional tension and emotions over the issues, his younger female colleague, dr. scott, begins to question him: terminating life support: out of the closet!, 295 new eng. j. med. 390, 390-91 (1976). 18 clark, supra note 3, at 30, 32. ken's reference to dr. frankenstein is a nod to an earlier drama. see generally manipulating fate, supra note 1, at 3-7, 22-28, 38-48. 19 id. vol. 11: 16 setting the stage dr. scott: but surely a wish to die is not necessarily a symptom of insanity? a man might want to die for perfectly sane reasons. 20 dr. emerson: [a] doctor cannot accept the choice for death; he's committed to life. when a patient is brought into my unit, he's in a bad way. i don't stand about thinking whether or not it's worth saving his life. i haven't the time for doubts. i get in there, do whatever i can to save life. i'm a doctor, not a judge. 21 dr. scott: i hope you will forgive me, sir, for saying this, but i think that is just how you are behaving-as a judge. 22 despite the power dynamics, ken manages to convince mr. hill, his attorney, to petition the court for a hearing to be held in the hospital to determine if ken is being deprived of his liberty and to request that he be allowed to die if found to have the requisite capacity. 23 from my perspective, one of the best theatrical dialogues that brings to life the perspectives of both the medical (dr. emerson) and legal (mr. hill) professions occurs in anticipation of the hearing: dr. emerson: i have every confidence that the law is not such an ass that it will force me to watch a patient of mine die unnecessarily. 2 4 hill: we are just as confident that the law is not such an ass that it will allow anyone arbitrary power. 25 dr. emerson: my power isn't arbitrary; i've earned it with knowledge and skill and it's also subject to the laws of nature. 26 20 id. at 51. 21 id. 22 id. 23 id. at 63-66. 24 id. at 71. 25 id. 2014 7 indiana health law review hill: and to the laws of the state. 27 dr. emerson: if the state is so foolish as to believe it is competent to judge a purely professional issue.28 hill: it's always doing that. half the civil cases in the calendar arise because someone is challenging a professional's opinion.29 dr. emerson: i don't know about other professions but i do know this one: medicine, is being seriously threatened because of the intervention of law. patients are becoming so litigious that doctors will soon be afraid to offer any opinion or take any action at all. 30 hill: you wouldn't like to find yourself powerless in the hands of, say, a lawyer or a . . . bureaucrat. i wouldn't like to find myself powerless in the hands of a doctor.31 dr. emerson: you make me sound as if i were some sort of dracula .... .32 hill: no! . . . i for one certainly don't doubt your good faith but in spite of that i wouldn't like to place anyone above the law. 33 dr. emerson: i don't want to be above the law; i just want to be under laws that take full account of professional opinion.34 the playwright sets the stage for the final scene in which the judge is to hear from the doctors, the lawyers, 26 id. 27 id. 28 id. 29 id. 30 id. 31 id. at 72. 32 id. 33 id. 34 id. vol. 11:1 8 setting the stage and ken himself. in this dialogue a number of issues are tackled that we continue to debate today-not only death with dignity, but the implications of our actions on others in society as well: judge: you tell me why it is a reasonable choice that you decided to die. 35 ken: it is a question of dignity. look at me here. i can do nothing, not even the basic primitive functions. i cannot even urinate, i have a permanent catheter attached to me. every few days my bowels are washed out. every few hours two nurses have to turn me over or i would rot away from bedsores. only my brain functions unimpaired but even that is futile because i can't act on any conclusions it comes to... . will you please listen?36 judge: i am listening.37 ken: i choose to acknowledge the fact that i am in fact dead and i find the hospital's persistent effort to maintain this shadow of life an indignity and it's inhumane. 38 judge: but wouldn't you agree that many people with appalling physical handicaps have overcome them and lived essentially creative, dignified lives? 3 9 ken: yes, i would but the dignity starts with their choice. if i choose to live, it would be appalling if society killed me. if i choose to die, it is equally appalling if society keeps me alive. 40 35 id. at 78-80. 36 id 37 id. 38 id. 39 d. 40 id. 2014 9 indiana health law review judge: i cannot accept that it is undignified for society to devote resources to keeping someone alive. surely it enhances that society. 41 ken: it is not undignified if the man wants to stay alive, but i must restate that the dignity starts with his choice. without it, it is degrading because technology has taken over from human will.42 the judge rules that ken is in "complete control of his mental faculties" and signs an order to "set him free," while expressing to dr. emerson how sorry he is and understanding how he must feel.43 to put this in context, not once during the drama did the playwright let ken express any doubt about his decision; he was funny, he was angry, but he was always very rational and articulate. interestingly, and perhaps intentionally, the playwright does not give voice to family or friends to challenge ken or complicate the issue. contrary to the medical community's presumption at the time that everyone would welcome the availability of new technology, ken, and in fact the public, began to question its value to extend life at all costs. just a few years after the play premiered, life imitated art and bouvia v. superior court44 was decided. elizabeth bouvia suffered from cerebral palsy and petitioned the court to prohibit a california hospital from force-feeding her so she could die. she was successful on appeal and found competent to make this decision. like the court in the play, the court in bouvia affirmed bouvia's right to secure her dignity to make the choice and control her destiny as best as she could. 45 as the decades passed, we 41 id. at 80. 42 id. 43 id. at 81. 44 225 cal. rptr. 297, 304-05 (ct. app. 1986). 45 she decided to exercise her right to remain alive for many years, comforted in knowing that she could change her mind at any time. see beverly beyette, the reluctant survivor: 9 years after helping her fight for the right to die, elizabeth bouvia's lawyer and confidante vol. 11110 setting the stage continued to establish the ethical and legal foundations of a right to die for both those with capacity and for those who could not make their own decisions. we asked ourselves how we could manipulate our fates. from baby doe46 to terry schiavo, 47 living wills to durable power of attorneys, and ethics committees to statutes and guidelines, we have questioned who should be able to make end-of-life decisions and have debated how those decisions should be made. many court cases expanded rights and began to tackle assisted suicide, and the debate still continues.48 iii. the normal heart the mid-1980s found both the medical community and the public confronted with a new and poorly understood infectious disease that was raging out of control: acquired immune deficiency syndrome ("aids").49 several killed himself -leaving her shaken and living the life she dreaded, l.a. times, sept. 13, 1992. 46 c. everett koop, the c. everett koop papers: congenital birth defects and the medical rights of children: the "baby doe" controversy, u. s. nat'l libr. of med., http://profiles.nlm.nih.gov/ ps/retrieve/collection/cid/qq (last visited aug. 25, 2013). 47 see generally gregory e pence, classic cases in medical ethics: accounts of cases that have shaped medical ethics, with philosophical, legal and historical backgrounds 29-55 (3d ed. 2000); sandra h. johnson et al., quinlan and cruzan: beyond the symbols, in health law and bioethics: cases in context 53-73 (2009); eric j. cassell, the schiavo case: a medical perspective, hastings center rep., may-june 2005, at 22; rebecca dresser, schiavo's legacy: the need for an objective standard, hastings center rep., may-june 2005, at 20; jay wolfson, erring on the side of theresa schiavo: reflections of the special guardian ad litem, hastings center rep., may-june 2005, at 16. 48 see, e.g., compassion in dying v. washington, 850 f. supp. 1454, 1459 (1994) (finding a liberty interest in choice to commit physician-assisted suicide), rev'd, 49 f.3d 586 (1995), affd on reh'g en banc, 79 f.3d 790 (1996), rev'd sub nom. washington v. glucksberg, 521 u.s. 702, 728 (1997) (finding no liberty interest in choice to commit physician-assisted suicide). 49 see carol levine & joyce bermel, aids: the emerging ethical dilemmas, in hastings center report (supp. 1985); see also ronald 2014 11 indiana health law review playwrights seized upon the opportunity to portray the evolution of this mysterious killer that would first grip the gay community and highlight the desperate search to gain control through innovations in medicine. larry kramer's 1985 play the normal heart provides a memorable platform for the theatre. kramer found it very difficult to get the play produced on broadway at the time, so joe papp, the eminent producer, staged it off broadway at the public theatre. this drama was based on kramer's personal and political experiences working as a gay activist, and he depicts himself in the character of ned weeks.50 the goal of the playwright is to capture the frustration of medical uncertainty and ethical dilemmas,51 in part through the characters of ned and dr. emma brookner, who was inspired by the life of dr. linda lauberstein, one of the first physicians to treat gay men in new york city during the early days of the epidemic. ned visits emma at her medical office: ned: in just a couple of minutes you told two people i know something. the article said there isn't any cure. 52 emma: not even any good clues yet. and even if they found out tomorrow what's happening, it takes years to find out how to cure and prevent anything. all i know is this disease is the most insidious killer i've ever seen or studied or heard about. and i think we're seeing only the tip of the iceberg. i'm frightened nobody important is going to give a bayer & amy l. fairchild, the genesis of public health ethics, 18 bioethics 476, 478 (2004). 50 patrick healey, larry kramer hand-delivers his latest message, n.y. times, (apr. 25, 2011, 11:04 am), http://artsbeat.blogs.nytimes.com/2011/04/25/larry-kramer-handdelivers-his-latest-message/?_r=0; letter from larry kramer, available at http://www.scribd.com/doc/53626456/pleaseknow-larrykramer. 51 see ren~e c. fox, the evolution of medical uncertainty, 58 milbank memorial fund q. health & soc'y 1, 13 (1980); robert steinbrook et al., ethical dilemmas in caring for patients with the acquired immunodeficiency syndrome, 103 annals internal med. 787 (1985); see also rothenberg, 'new" genetics, supra note 1, at 411, 426; rothenberg & bush, manipulating fate, supra note 1, at 40. 52 kramer, supra note 5, at 22. vol. 11:112 setting the stage damn because it seems to be happening mostly to gay men.53 later in the play, ned reacts: ned: we're all going to go crazy, living this epidemic every minute, while the rest of the world goes on out there, all around us, as if nothing is happening, going on with their own lives and not knowing what it's like, what we're going through.54 kramer's powerful dialogue further dramatizes how attitudes on the morality of homosexuality can blind society to the urgency of addressing a stigmatizing, major public health threat-much like the dynamic witnessed years earlier with the syphilis epidemic also expressed in plays like ghosts5 5 and spirochete.56 stressing that access to health care is a matter of justice, emma states: emma: health is a political issue. everyone's entitled to good medical care. if you're not getting it, you have to fight for it.57 the normal heart captures the complexity of relationships within the gay community, medical profession, and government officials. they all played roles-both positive and negative-in the search for innovative s id 54 id. at 99. 55 henrik ibsen, ghosts, in four major plays: ghosts; and an enemy of the people; the lady from the sea 1 (rolf fjelde trans., signet classics 2d. 1970); see also rothenberg & bush, manipulating fate, supra note 1, at 10-11; rothenberg, "new" genetics, supra note 1, at 408 n.2; rothenberg and bush, drama of dna, supra note 1, at pt. iii, ch. 6, at 27. 56 see arnold sundgaard, spirochete (1938), available at http://dspace.wrlc.org/doc/bitstream/2041/60699/spirochetedisplay.pdf; ronald bayer, private acts, social consequences: aids and the politics of public health (1989) erving goffman, stigma: notes on the management of spoiled identity (1963); see generally rothenberg & bush, mani ulating fate, supra note 1, at 18-19. 57 kramer, supra note 5, at 25. 2014 13 indiana health law review strategies to understand the cause, prevention, and treatment of aids. 5 8 when ned attempts to convince his gay friends that they must avoid dangerous sexual practices and take personal responsibility for their actions, a theme often expressed during a public health campaign, his colleague bruce retorts: bruce: but we can't tell people how to live their lives! we can't do that.59 ned: you make it sound like that's all that being gay [having sex] means.60 and emma makes clear: emma: i don't consider going to the baths and promiscuous sex making love. i consider it the equivalent of eating junk food, and you can lay off it for a while. and yes, i do expect it.61 ned: why are you yelling at me for what i'm not doing? where's the goddamned ama in all of this? the government has not started one single test tube of research. 62 with great frustration, emma acknowledges the discrimination and unethical practices she is witnessing while she works hard to piece together "treatment of several chemotherapies used together"63 without success, but this is 58 see lawrence 0. gostin, hiv screening in health care settings: public health and civil liberties in conflict?, 296 j. am. med. ass'n 2023 (2006); larry gostin, vaccination for aids: legal and ethical challenges from the test tube, to the human subject, through to the marketplace, 2 aids pub. pol'y j. 9 (1987); beatrix hoffman, health care reform and social movements in the united states, 93 am. j. pub. health 75 (2003). 59 kramer, supra note 5, at 47. 60 id. 61 id. at 72. 62 id. 63 id. at 85. vol. 11:114 setting the stage the best she can do to try to help them. her patients are all guinea pigs with no approved research protocol and no clear course to follow. this is another theme that emerges when trying to address how to respond to new public health threats and medical mysteries, especially among marginalized populations: emma: [y]ou won't get particularly good care anywhere, maybe not even here. at . . . i'll call it hospital a, you'll come under a group of mad scientists, research fanatics, who will try almost anything and if you die you die . .. you'll just be a statistic for their computer-which they won't share with anyone else, by the way; there's not much sharing going on, never is-you'll be a true guinea pig. at hospital b, they decided they really didn't want to get involved with this, it's too messy . . . c is like the new york times and our friends everywhere: square, righteous, superior, and embarrassed by this disease and this entire epidemic."64 in spite of emma's best efforts, ned's lover, felix, is dying of aids, and he shares with ned his frustration and desperation in losing control of his life: ned: are you ready to get up yet? and eat something?65 felix: no!-i've had over forty treatments. no!-i've had three, no four different types of chemo. no!-i've had interferon, a couple kinds. i've had two different experimentals.... none of it has done a thing. i've had to go into the hospital four times-and please god don't make me go back into the hospital until i die. eighty-five percent of us are dead after two years. . . . emma has lost so many patients they call her dr. death. you cannot force the goddamn sun to come out.6 6 64 id. at 85-86. 65 id. 66 id. at 112-13. 2014 15 indiana health law review yet felix is not quite ready to give up control of his life. he strives for dignity, for some normalcy; he writes his will, and he and ned are "married" by emma in his hospital room shortly before he dies.67 as w.h. auden wrote in his poem september 1,1939, the inspiration for the title of kramer's play, "[wihat . . . is true of the normal heart ... [wle must love one another or die."68 as it became clear that aids was spreading out of control with no hope in sight, the scientists, physicians, community activists, politicians and society-at-large were struggling to find their moral compass to guide them on how best to control the fate of this disease. twenty-five years later, the normal heart was revived on broadway to rave reviews, thanks in part to changes in societal attitudes and the passage of time to reflect on new perspectives. although there is still no cure, the virus had been discovered, treatments were developed, research on a vaccine continued, antidiscrimination and privacy laws were passed, and new prevention strategies were developed. aids activists demanded access into research protocols as a means of treatment. the research paradigm shifted from protection against harms to access to benefits, and ethical debates over the access to treatment continue around the world. this challenged us to respond more humanely to social justice issues when confronted with worldwide public health epidemics. iv. the twilight of the golds by the 1990s, the development of a "new" genetics, together with concerns about bioethics, had set the stage for the initiation of the human genome project and a major societal challenge: how do we allow the promise of science to move forward and at the same time keep in check the perils of what we learn?6 9 as part of the effort to map the human 67 id. 68 w.h. auden, september 1, 1939, the new republic, oct. 18, 1939, at 297. 6 see eric t. juengst, the human genome project and bioethics, 1 kennedy inst. ethics j. 71 (1991). vol. 11:116 setting the stage genome, the project allocated federal funding to establish the ethical, legal, and social implications ("elsi") program to "inspire a cohort of ethicists, social scientists, legal scholars and others to address the coming dilemmas associated with increased knowledge about the genome, from social and legal discrimination to more philosophical issues such as genetic determinism."70 the debates that surround these implications continue to be explored by bioethicists and through popular culture, including theatre. in fact, many of the same debates and questions that surrounded the eugenics movement at the beginning of the twentieth century have been raised.71 the vision of an improved society through regulating reproduction continues. 72 the "new genetics" holds the implicit promise of ending human disease, yet it also "raises familiar questions about the social perception of normality and the potential for discrimination on the basis of race, disability, sexuality, class, and gender."73 staged on broadway in 1993, the twilight of the golds by jonathan tolins examines the potential exercise of prejudice in the choices surrounding genetics.74 tolins was prompted to hypothesize about the impact of genetic testing for homosexuality after reading two separate studies, both now discredited.7 5 the plot centers on suzanne, who, through fictional cutting-edge technology performed in her husband rob's lab, discovers that her fetus will very likely be gay. 76 early on in the play, even before she gets tested, 70 francis s. collins & victor a. mckusick, implications ofhuman genome project for medical science, 285 jama 540, 541 (2001); see also rothenberg, 'new" genetics, supra note 1, at 425; rothenberg & bush, manioulating fate, supra note 1, at 49; rothenberg & bush, drama of dna, supra note 1, pt. iii, ch. 6, at 1. 71 rothenberg, 'new" genetics, supra note 1, at 426. 72 id. 73 id. at 411. 74 tolins, supra note 6. 75 id. one purported to find a scientific basis for inborn homosexuality and the other claimed to isolate differences in a region of the brain between homosexual and heterosexual men. id.; see also rothenberg, 'new" genetics, supra note 1, 428. 76 rothenberg & bush, drama of dna, supra note 1, pt. iii, ch. 6, at 8. 2014 17 indiana health law review tolins sets up the tension between david, suzanne's gay brother who serves as the narrator and her husband, rob. 77 david: face it, rob, this is [elugenics. it's blatant nazi philosophy.7 8 rob: oh, here we go. every time there's the slightest scientific advance, some knee-jerk liberal starts shouting about the nazis. we are just trying to make life better?7 . . . let's use every weapon we have.... is that such a horrible thing to think?8 0 the moral dilemma revealed by the idea of genetic testing for certain traits is articulated through the argument between rob, a geneticist whose work on the human genome project leads him to see a future in which much unnecessary suffering could be avoided through prenatal testing, and david, who analogizes rob's work to nazi eugenics. 8 ' rob's company has developed new technology for individual gene identification that would allow parents to terminate fetuses with specific problems or "abnormalities."82 alluding to the deceptive perception of genetics as an infallible "code" that defines every human characteristic, rob does admit: rob: [i]t's not like we can point to one gene and say 'aha.' it's the whole composite of evidence that's open to interpretation. 83 suzanne: so, it could be a mistake.84 rob: 90% sure.85 77 id. pt. iii, ch. 6, at 8-9. 78 tolins, supra note 6, at 40-41. 79 id. at 41. 80 id. at 85. 81 rothenberg, "new" genetics, supra note 1, at 427. 82 id. 83 tolins, supra note 6, at 56. 84 id. 85 id. 18 vol. 11:1 setting the stage suzanne: what about environment? i mean if we knew before, couldn't we raise it in a way that ... 86 rob: . . . judging by how clearly it shows up in the statistical evidence, we'd have a lot of nature to nurture against.87 clearly, tolins has brought to life the debate over genetic essentialism and determinism.8 8 in response to rob, suzanne shares her hopes and disappointments: suzanne: this baby was going to change our lives and make everything better. not that things are bad ... now the whole thing is tainted. i wish we didn't know, but we do. and it's a problem.89 we can only hope that this would not be the response in 2014, but it is possible that it might be for another trait or condition. in many ways, the burden of genetic testing rests primarily with the woman, as she is the sole subject of the testing.90 the greater knowledge that these technologies provide is accompanied by greater pressure to do as much as possible to give birth to a "perfect and healthy" child. suzanne is torn between the pressure from her husband, her parents, and society, and her love and respect for her brother david. when she finally decides to abort at five months, it leads to complications that require her to have a hysterectomy. david, once very close to both his sister and parents, never speaks to them again.9' 86 id. 87 id. at 57. 88 rothenberg, 'new"genetics, supra note 1, at 426-27. 89 id. at 78. 90 rothenberg, 'new" genetics, supra note 1, at 427. 91 tolins, supra note 6, at 78. interestingly, the film version of tolins' play revises the ending, perhaps to placate mainstream america's aversion to observing abortion. the twilight of the golds (fox lorber 1970) [hereinafter twilight of the golds film]; see also rothenberg, 'new" genetics, supra note 1, at 429. in the film, suzanne decides not to abort the fetus and repairs her relationship 2014 19 indiana health law review in an interview, tolins said that his play asks how "we [are] going to live together if we are suddenly given [a] godlike ability to reshape humanity" and what "criteria are we going to use if we want those we consider undesirable to die."9 2 these questions are illuminated in a dialogue between david and suzanne: david: "[what if you found out the kid was going to be ugly, or smell bad, or have an annoying laugh, or need really thick glasses . . .. [w]here do we stop? . .. so now we have this technology, what are we going to do with it?93 suzanne: why are you doing this?94 david: because i'm fighting for my life.9 5 though the research on the "gay gene" has since been firmly rejected, tolins expresses a prevalent concern for the discriminatory potential of genetic testing, challenging, in this case, the idea that the medical basis of homosexuality would increase tolerance toward individuals who are gay. however, the ethical implications are complex: though the existence of a gay gene might shift the responsibility from a person's actions to his or her genetic makeup, it could also lead to the biological control of homosexuality. 96 in fact, any attempts to use genetic information to explain behavior will be fraught with conflict. what ever happened to free will? with her brother. twilight of the golds film; see also rothenberg, 'new" genetics, supra note 1, at 429. the film concludes with a flashforward to the baby's happy childhood. twilight of the golds film; see also rothenberg, 'new" genetics, supra note 1, at 429. 92 alvin klein, young playwright feels critics' sting, n.y. times, nov. 7, 1993, http://www.nytimes.com/1993/11/07/nyregion/youngplaywright-feels-critics-stings.html?pagewanted=l, quoted in rothenberg, 'new" genetics, supra note 1, at 428. 93 tolins, supra note 6, at 78. 94 id. at 79. 95 id. 96 see karen h. rothenberg, the law's response to reproductive genetic testing' questioning assumptions about choice, causation, and control, 8 fetal diagnosis & therapy 160 (1993). 20 vol. 11:1 setting the stage tolins imagined and warned of a future in which prenatal genetic screening is commonplace, as it is now, and in which gene-based discrimination is a very real threat, which we hope to have averted to some extent in the employment and health insurance context. in 2008, after more than a decade of debate, congress passed the genetic information nondiscrimination act ("gina"), which prohibits health insurance providers and employers from discriminating based on genetic information and provides certain privacy protections.97 though gina does make some progress into addressing concerns about the misuse of genetic information in contexts such as these, it does not address bigger societal concerns, including implications for reproduction of genetic information, reconceptualization of normalcy, tolerance for difference, and the right to an open future.98 v. next to normal in fact, examining the search for a normal life, a dignified life, and a right to control one's own destiny reveals the tension between bioethical challenges and their solutions-explored in many plays throughout the last few decades, especially the twenty-first century. brian yorkey's musical next to normal, the 2010 pulitzer prize winner in drama,99 depicts the desperate search for medical innovations to control diana's severe psychiatric bi-polar disorder, her depression with delusional episodes, and her sixteen-year history of medication. the musical revolves around diana, her family, and her many doctors' struggle to find her an effective treatment regimen and the implications of these exhausting attempts to get her to function at least "next to normal." through a 9 42 u.s.c. § 2000ff-5 (2013); see also rothenberg, 'new" genetics, supra note 1, at 426. 98 rothenberg, "new" genetics, supra note 1, at 426; see also jessica l. roberts, the genetic information nondiscrimination act as an antidiscrimination law, 86 notre dame l. rev. 597 (2011). 9 the pulitzer prizes: drama, colum. univ., http://www.pulitzer.org/bycat/drama (last visited oct. 24, 2013). 2014 21 indiana health law review series of powerful musical numbers and dialogue, diana and the psychiatrists explore how the evolving list of different medical interventions from psychopharmacology to hypnosis to electroconvulsive therapy ("ect") may control her fate, and theirs, for better or for worse. diana sets the stage for her desperation. she is trying to balance the risks and benefits of treating mental illness, which often leads to ethical challenges: diana: do you wake up in the morning and need help to lift your head? do you read obituaries and feel jealous of the dead? it's like living on a cliffside not knowing when you'll dive ... do you know do you know what it's like to die alive? 00 yorkey sets up the context for challenges faced by diana, her doctors, and her family. after so many years experimenting with different drugs, it is clear that there is no quick fix. in song, diana and her psychiatrist, dr. fine, describe it well: dr. fine: the round blue ones with food but not with the oblong white ones. the white ones with the round yellow ones but not with the trapezoidal green ones. split the green ones into thirds with a tiny chisel.10 1 diana: i've got less anxiety, but i have headaches, blurry vision, and i can't feel my toes. 102 dr. fine: so we'll try again, and eventually we'll get it right. 103 diana: not a very exact science, is it?104 100 yorkey, supra note 7, at 32. 101 id. at 17. 102 id. at 18. 103 id. vol. 11:122 setting the stage unfortunately, it is not an exact science. and this reality can pose ethical dilemmas along with trying to sort out who gets to decide what is "right" and for whom? there is often a trade-off for the patient in trying to achieve even a semblance of normalcy with medication to survive within the family and in society-and in missing the person you think you really are-especially with the highs. diana reflects in song: diana: all these blank and tranquil years seems they've dried up all my tears.... but i miss the mountains. i miss the dizzy heights. all the manic, magic days, and the dark depressing nights. . . . mountains make you crazy here it's safe and sound. my mind is somewhere hazy my feet are on the ground..... i miss the mountains ... i miss my life.105 diana's condition gets worse, and she and her husband dan visit yet another psychiatrist, dr. madden. they are desperate for answers and explanations about diana's past and her family: dr. madden: often the best we can do is put names on collections of symptoms. it's possible bipolar has more in common with schizophrenia than depression.106 diana: when i was young, my mother called me "highspirited." she would know. she was so high-spirited they banned her from the pta.107 104 id. 105 id. at 26. 106 id. at 39. 107 id. 2014 23 indiana health law review dr. madden: sometimes there's a predisposition to illness, but actual onset is only triggered by some . . . traumatic event. 08 in fact, we soon discover that diana's deepening depression was over the death of her infant son years ago, which intensifies her biopolar episodes. unable to cope with all the medicines and her mounting sadness, she attempts suicide and is rushed to the hospital. doctor madden recommends ect, or shock therapy for short, calmly stating to dan: dr. madden: the modern procedure's clean and simple. hundreds of thousands of patients receive it every year.109 we can administer the ect and you can bring her home in ten days. or we can keep her sedated for forty-eight hours, then discharge her and wait for her to try again.110 legally, we need her consent. hospital policy is we need yours, too.111 dan: i don't think she's gonna go for this.112 but in desperation, she does go for it. the play exposes us to the ethical issues at stake when trying to secure informed consent and determine decision-making capacity for individuals with psychiatric conditions.113 in fact, in an interview, yorkey shared that it was an article about mental illness and the administration of ect over a decade prior that sparked his interest in writing the musical.114 108 id. 109 id. at 56. 110 id. at 53. 111 id. 112 id. 113 thomas grisso & paul s. appelbaum, assessing competence to consent to treatment: a guide for physicians and other health professionals (1998). 114 patricia cohen, mental illness, the musical, aims for truth, n.y. times (apr. 16, 2009), http://theater.nytimes.com/2009/04/19/ theater/19cohe.html?pagewanted=all&_r=0 (last visited aug. 30, 2013). vol. 11:124 setting the stage ect has a long and controversial past, and the pendulum of public opinion has swung back and forth, both in response to early abuses and, more recently, to guidelines and strict rules for administering ect, often limited to being a last resort. the new guidelines have been implemented along with extensive informed consent processes.115 as yorkey reminds us of one flew over the cuckoo's nest from the 1960's,116 diana sings: diana: didn't i see this movie, with mcmurphy and the nurse? that hospital was heavy but this cuckoo's nest is worse. 117 in recent years and with major advancements in the technology, ect has been considered a life-saver for many suffering from severe depression.118 ironically, it also raises new ethical challenges for ensuring that access to the therapy is available for those who want it and can prove that they have the capacity to consent. for diana, ect is not the cure. frustrated after weeks of memory loss, she reflects with dr. madden on all that she has tried, with limited success: diana: they told me that the wiring was somehow all misfiring and screwing up the signals in my brain. and then they told me chemistry, the juice, and not the circuitry, 115 see generally the ect handbook 12 (allan i.f. scott ed., bell & bain limited 2d ed. 2005); matthew v. rudorfer et al., electroconvulsive therapy, in psychiatry 1865-901 (allan tasman et al. eds., 2003). 116 ken kesey, one flew over the cuckoo's nest (1962); see generally rothenberg & bush, manioulating fate, supra note 1, at 2627. 117 yorkey, supra note 7, at 56. 118 leon e. rosenberg, brainsick: a physician's journey to the brink, cerebrum (oct. 1, 2002), http://www.dana.org/news/cerebrum/ detail.aspx?id=2884 (last visited oct. 28, 2013). 2014 25 indiana health law review was mixing up and making me insane .. . 119 dr. madden: relapse is very common, diana... stay with me. try again. is medicine magic? you know that it's not. we know it's not perfect, but it's what we've got.120 ethically, it was important that the psychiatrist not give up on the patient. and in the end, diana is well enough to express her feelings to her daughter natalie, who has been struggling with the impact of her mother's mental illness on her life: diana: we wanted to give you a normal life, but i realize i have no clue what that is.121 natalie: i don't need a life that's normalthat's way too far away. but something . .. next to normal would be okay.122 vi. conclusion we are left with fundamental ethical questions brought to life by all of these plays: what is normal? and who decides? characters in theatre dramatize both the promises and perils of medical interventions, and the uncertainties of our futures, be they in the context of a dignified death, a public health epidemic, new genetic technologies, or treatments for mental illness. what does it mean to live a normal life? how can we control our fate? what impact will our decisions have on our family, professionals and society? these are questions that set the stage for the next act. hopefully, they will stimulate discussion among our colleagues on how theatre may 119 yorkey, supra note 7, at 89. 120 id. at 90. 121 id. at 94. 122 id. vol. 11: 126 2014 setting the stage 27 further enhance our understanding of the bioethical challenges we face together. plea for consumer protection: the potential human health hazards of the spray tanning epidemic, a a plea for consumer protection: the potential human health hazards of the spray tanning epidemic jessica m. dugdale* i. introduction .................................... 348 ii. spray tan solutions......................... 354 a. dihydroxyacetone (dha) ................ ..... 355 b. dha application approved for external use only... 357 c. adverse health effects of spray tan application ..... 358 d. dha has no regulatory status................. 360 iii. initial governmental response to indoor tanning regulation.................................... 361 a. governmental response to indoor uv tanning....... 361 b. governmental response to indoor sunless tanning 365 iv. current indoor tanning regulations ..... ...... 366 a. federal in door tanning regulations ..... ....... 366 1. the fda: regulating color additives and tanning devices under the ffdca ................... 367 2. the ftc regulating advertising claims by the indoor tanning industry......................... 372 3. tanning accountability and notification act of 2007..................................... 375 4. tanning tax......................... 376 b. state tanning regulations... ................. 377 1. state indoor uv tanning regulations..... .... 378 2. state indoor spray tanning regulations............... 382 3. indiana spray tanning regulations ...... ..... 383 v. future indoor spray tanning regulations............. 385 a. rigorous federal regulation of the in door spray tanning industry..................... ........ 385 b. enhanced state and local health authority regulation of indoor spray tanning............. 387 c nationwide minimum age requirements for indoor * j.d. candidate, 2014, indiana university robert h. mckinney school of law, indianapolis, indiana; b.a., december 2010, depauw university, greencastle, indiana. indiana health law review spray tanning........................ 388 vi. regulatory alternatives ......................... 390 a. promoting consumer education... ........... 390 b. encouraging self-regulation, operator education, and appropriate advertising by salons ..... ..... 393 c. endorsing safer alternatives to achieving a tanned appearance ........................... ..... 395 d. changing perceptions about desirable skin colors. 396 vii. conclusion................................... 397 i. introduction human skin performs several critical functions including protection, sensation, temperature regulation, storage, excretion, absorption, and water resistance. 1 being the largest organ and most visible part of the human body, the skin deserves adequate protection from external sources of potential harm. human skin, however, is frequently exposed to the sun, and many united states (u.s.) consumers have become engrossed with sustaining a bronzed appearance. 2 in the u.s., communities have long been plagued by skin color politics. 3 the historical roots of skin color stratification indicate differing reactions to light skin tones. 4 once an indicator of an elegant lifestyle, a fair 1 u.s. dep't of health and human servs., radiation-emitting products: basic skin anatomy, u.s. food and drug admin., http://www.fda.gov/radiation-emittingproducts/ radiationemittingproductsandprocedures/tanningucm116428.htm (last updated may 4, 2009). 2 daniel j. sheehan & jack l. lesher, jr., the effect of sunless tanning on behavior in the sun: a pilot study, 98 s. med. j. 1192 (2005). 3 margaret hunter, skin deep: how race and complexion matter in the "color-blind" era, 22-38 (cedric herring et al eds., 2004). 4 id. at 22. vol. 11: 1348 a plea for consumer protection complexion is typically no longer desirable in the u.s. 5 evidence of a culture that presently encourages compulsive tanning, the current coveted appearance includes a bronzed skin tone. 6 a 2009 study explains, "cultural attitudes shifted dramatically to favor skin tanning for cosmetic reasons during 1928 and . . . tanning has been a cultural norm in the [u.s] for approximately [four] generations."7 indoor tanning salons provide individual beds comprised of tanning lamps that expose consumers to high intensities of ultraviolet (uv) rays in short doses to produce a tanned appearance.8 similarly, indoor tanning salons offer uv-free tanning whereby spray tanning devices coat the skin with a sunless tanning solution to deliver a faux glow.9 5 andrea y. loh, note, are artificial tans the new cigarette? how plaintiffs can use the lessons of tobacco litigation in bringing claims against the indoor tanning industry, 107 mich. l. rev. 365, 366 (2008) (citing hunter, supra note 3, at 23). 6 id. (citing julie rawe, why teens are obsessed with tanning, time, july 6, 2006, at 1 (discussing the "frightening spike in cancer rates among the young," increasing incidence of melanoma, and estimating that 2.3 million teens supported the $5 billion-a-year tanning industry as of 2006)); see mary t. pawlak et al., legislation restricting access to indoor tanning throughout the world, 148 arch. dermatol. 1006 (2012) ("on average, [one] million people use tanning beds per day in the united states, and nearly [twenty-eight] million people use tanning beds annually.") (internal citations omitted). 7 jo m. martin et al., changes in skin tanning attitudes: fashion articles and advertisements in the early 20th century, 99 am. j. of pub. health 2140, 2145 (2009), available at http://ajph.aphapublications.org/doilpdf/10.2105/ajph.2008.144352 (examining changes in tanning attitudes portrayed in popular women's press in the 1920s and 1930s); see, e.g., jane brody, a healthy glow that's truly healthy, new york times (july 6, 2009), http://www.nytimes.com/2009/06/02/health/02brod.html? r=0 (discussing attitudes about tans whereby a 2009 survey "found that the more westernized the respondents, the more positive their attitudes toward tanning and sunbathing."). 8 u.s. dep't of health and human servs., radiation-emitting products: tanning products, u.s. food and drug admin., http://www.fda.gov/radiation-emittingproducts/ radiationemittingproductsandprocedures/tanning/ucm1 16434.htm (last updated apr. 17, 2013). 9 id. 2014 349 indiana health law review the dangers of uv exposure are of increasing concern to frequent sun-seekers, and a 2009 world health organization (who) study confirmed that fear by declaring tanning beds to be carcinogenic. 10 linking detrimental health effects to sun exposure, including premature skin aging and an increased risk of cancer, many consumers have turned to sunless tanning alternatives." between 2003 and 2008, sales of sunless tanning products quadrupled. 12 the national toxicology program suggests, "[slunless tanning products represent about 10% of the $400 million market for suntan preparations, and these products are the fastest growing segment."13 though advocated as a safer alternative to uv exposure, sunless tanning may not 10 veronica knapp, note, fda s regulation of tanning beds: how much heat?, 66 food & drug l.j. 25 (2011) (internal citation omitted). 11 bruce a. brod, tanning industry exposed: evidence demonstrates link between indoor tanning and skin cancer, aad.org (aug. 16, 2012), http://www.aad.org/stories-and-news/newsreleases/tanning-industry-exposed-evidence-demonstrates-link-betweenindoor-tanningandskin-cancerdermatologists-committed-to-educatingpublic-on-risks (last visited july 6, 2013); jennifer m. fu et al., sunless tanning, 50 j. am. acad. dermatol. 706 (2004); sheehan & lesher, supra note 2, at 1194 ("in recent years the american public has become more aware of sunless tanning methods as an alternative to uv[1 tanning, and as the newer sunless tanning formulations provide a cosmetically improved color, their use has increased.") (internal citations omitted); see lawrence g. cetrulo, spray tan litigation, in 4 toxic torts litigation guide § 38:14 (2012) ("spray tans as an alternative to [uv] radiation from tanning beds have become increasingly trendy.") (internal citation omitted). 12 anne mahoney et al., attitudes toward indoor tanning among users of sunless tanning products, 148 arch. dermatol. 124, 124-126 (2012) (citing christopher muther, you're not bronzed: that tan is fake!, the boston globe (may 21, 2009), http://www.boston.com/ lifestyle/fashion/articles/2009/05/21/youre not bronzedthat-tan is fak e/ ("sales of self-tanners in the united states have skyrocketed in the past five years. in 2003, sales totaled $53 million. by 2008, sales surpassed $200 million, according to market research group mintel international group, ltd.")). 13 u.s. dep't of health and human servs., summary of data for chemical selection: dihydroxyacetone 96-26-4, nat'l toxicology program (feb. 21, 1998), http://ntp.niehs.nih.gov/ntp/htdocs/ chembackground/exsumpdfldihydroxyacetone_508.pdf [hereinafter dha summarya. vol. 11:1350 a plea for consumer protection be a preventive measure. 14 while there are no proven adverse health effects associated with the regular use of sunless tanning products, the uninvestigated effect of prolonged human exposure suggests that conceivable harms remain largely unknown. 15 since the introduction of spray tanning booths into the u.s. market in 1999, the indoor tanning industry has embraced this novel technology endorsed as a means to obtain healthy skin and a flawless glow. 16 spray tanning booths function by misting an even coat of sunless tanning solution onto a consumer's exposed skin.17 while spray tans have been available for a number of years, the general public has acted under the assumption that the u.s. food and drug administration (fda) has approved the use of spray tanning devices. this notion is incorrect. in 1977, prior to the development of spray tans, the fda approved the use of dihydroxyacetone (dha) for external 14 christine l. paul et al., harm minimization in tan seekers: an exploration of tanning behaviour and the potential for substitution use of sunless tanning products, 16 j. of health psychol. 929, 934 (2011) ("[s]unless tanning products are considered a tanning add-on or top-up rather than a substitute for exposure to uv light."). 15 mark greenblatt & gitika ahuja, are 'spray-on' tans safe? experts raise questions as industry puts out warnings, abc news (june 12, 2012), http://abcnews.go.com/health/safety-popular-spraytans-question-protected/story?id=16542918 ("none of the reviewed studies tested on actual human subjects, but some found dha altered genes of multiple types of cells and organisms when tested in different labs by different scientists after the chemical was approved for use in the consumer market."). 16 fu et al., supra note 11, at 709 (citing kerry curry, sunless tan system heats up sales for cowtown firm, dallas business journal (apr. 14, 2002 11:00 pm cdt), http://www.bizjournals.com/dallas/ stories/2002/04/15/story2.html). 17 id. at 706 ("never before has a cosmetically acceptable, fullbody, sunless tan been so accessible and so affordable for the masses."). while this note focuses exclusively upon the human health hazards associated with routine spray tan exposure, the sunless tanning mist emitted from spray tan booths may implicate clean air act violations as well. see clean air act, 42 u.s.c. § 7401, et seq. (2012) ("[alir pollution prevention (that is, the reduction or elimination, through any measures, of the amount of pollutants produced or created at that source) and air pollution control at its source is the primary responsibility of the states and local governments."). 2014 351 indiana health law review application only.18 dha is the primary chemical ingredient used in spray tan solutions and is a commonly used color additive that reacts with amino acids in the skin's surface causing dead skin cells to darken. 19 this chemical ingredient is not unique to sunless tanning booths in the u.s., as dha has been used in cosmetic products worldwide. 20 the federal food, drug, and cosmetic act (ffdca) empowers the fda to oversee the safety of food, drugs, and cosmetics in the u.s.21 while dha is a "color additive" exempt from the certification requirements of the ffdca, fda certification is required in order for dha to be used in cosmetic products. 22 a "color additive" is defined by the code of federal regulations (cfr) to mean: a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting a color thereto. 23 18 21 c.f.r. § 73.2150 (2013). 19 due to the reactive relationship between dha and human skin, "[m]ost sunless tanning products contain the active ingredient [dha]." sheehan & lesher, supra note 2, at 1194 (describing dha as "a 3carbon sugar that combines covalently with basic groups of proteins in the stratum corneum in a browning reaction known as the maillard reaction."). 20 european comm'n, scientific committee on consumer safety' opinion on dihydroxyacetone, ec.europa.eu (dec. 14, 2010), http://ec.europa.eu/health/scientificcommittees/consumersafety/docs/sc cs_o_048.pdf. 21 federal food, drug, and cosmetic act, pub. l. no. 75-717, 52 stat. 1040 (1938) (codified at 21 u.s.c. § 301 (2013)). 22 21 c.f.r. § 73.1150(e) a. 23 id. § 70.3(f). 352 vol. 11:1 a plea for consumer protection if a consumer inhales or ingests dha during spray tan application, the consumer is not sufficiently protected from its unapproved use. 24 while manufacturers and salon professionals have a duty to ensure that dha-containing cosmetic products are marketed, labeled, and appropriately used under customary conditions, the national and local health authorities must oversee the proper administration of sunless tanning products, including spray tanning booths.25 spray tanning has no proven adverse health effects apart from allergic reactions. 26 nevertheless, the fda is clear that dha should not be inhaled or ingested because no safety data to support the regular human use of dha as an all-over spray has been submitted to the fda for evaluation. 27 while the fda has approved dha to be externally applied for skin darkening, it states that dha "should not be inhaled, ingested, or exposed to areas covered by mucous membranes including the lips, nose, and areas in and around the eye" due to uninvestigated health risks.28 because the tanning industry "has not provided safety data to [the] fda in order for the agency to consider approving it for use on these exposure routes, including 'misting' from tanning booths," the use of dha as an all-over spray has not yet been approved.29 a 2003 study found that a majority of businesses with spray tanning booths largely lacked "recommendations for protection of the entire area of the eye as defined by the fda, the lips, and the mucous membranes." 30 arguably, 24 u.s. dep't of health and human servs., cosmetics: sunless tanners and bronzers, u.s. food and drug admin., http://www.fda.gov/cosmetics/productandlngredientsafety/productinfor mation/ucml34064.htm (last visited july 6, 2013) [hereinafter sunless tanners guidance]. 25 id. 26 nevertheless, increasing usage of spray tanning "may pose health risks . . . that could develop into future toxic tort litigation." cetrulo, supra note 11 (internal citation omitted). 27 sunless tanners guidance, supra note 24. 28 id. 29 id. 30 fu et al., supra note 11, at 712 (discussing that the majority of sunless tanning businesses suggested that consumers "close their eyes 2014 353 indiana health law review spray tanning salons are not adequately protecting consumers. not only do consumers have the right to be protected from the potential risks of dha exposure, but consumers also have the right to be sufficiently informed of the uninvestigated nature of the primary tanning ingredient employed by spray tanning booths. this note discusses the inadequate legal protection of consumers who utilize spray tanning booths, which have not been approved by the fda due to a lack of safety data supporting regular human exposure. this note explores both past and present federal and state regulation of the indoor tanning industry and examines the effectiveness of that regulation in protecting consumers. to advocate for a comprehensive approach toward increasing consumer protection through more stringent spray tanning regulations as well as non-regulatory measures, section ii discusses the general background, ingredients, approved uses, known adverse effects, and current regulation of sunless tanning solutions. section iii analyzes the evolution of the indoor tanning industry, comparing the regulation of indoor uv tanning to the lack of regulation of spray tanning. likewise, section iv elaborates on the differences between federal and state regulation of indoor uv and spray tanning. section v of this note offers predictions and recommendations for future spray tanning regulations, and section vi examines non-regulatory alternatives that may provide greater consumer protection. section vii will conclude the note. ii. spray tan solutions this note advocates for a comprehensive approach toward increasing consumer protection, which includes the implementation of more stringent spray tanning regulations in addition to non-regulatory alternative measures. understanding the ingredients, current regulation, and unknown risks of spray tan solutions are important in advocating for greater consumer protection. this section (100% 17/17), hold their breath (77% 13/17), and implement postsunless tanning sun precautions (82% 14/17)."). 354 vol. 11:1 a plea for consumer protection explains the general background of the primary chemical ingredient in spray tan solutions: dha. this section also covers definitions found within the cfr that pertain to dha, offers details about other ingredients commonly found in spray tan solutions, and explains how the lack of current dha regulation may adversely affect consumers. a. dihydroxyacetone (dha) dha is known as the primary active ingredient in spray tan solutions that causes the human skin to darken. 31 while proponents express that spray tanning is a safer alternative to sunbathing, accidental inhalation or ingestion of dha during spray tan application may have a host of unknown, unproven health risks. 32 further, "knowledge about the potential toxicity and mutagenicity of dha is very limited."33 no long-term human studies have been undertaken to examine the health effects associated with the regular use of dha-based tanning solutions.34 evidence suggests that dha presents "a risk of doing serious damage at a cellular level."3 5 thus, dha could have mutagenic potential, and "[t]he genotoxic capacity of dha raises a question about the long-term clinical consequences of treatment of the skin with this commonly used compound."36 because of the uninvestigated health effects of dha, spray tan consumers could be routinely engaging in an activity unaware of the potential consequences. in 2012, abc news compiled ten recent studies that examined "chemicals used in tanning sprays and asked a 31 anita b. peterson et al., dihydroxyacetone, the active browning ingredient in sunless tanning lotions induces dna damage, cellcycle block, and apoptosis in cultured hacat keratinocytes, 560 mutation research/genetic toxicology and envt'l mutagenesis 173, 173-74 (2004), available at http://www. sciencedirect.comlscience/ article/piils1383571804000555. 32 sunless tanners guidance, supra note 24. 33 peterson et al., supra note 31, at 174. 34 beth levine, spray tan dangers, the baseline of health foundation (jun. 26, 2012), http://www.jonbarron.org/article/spraytan-dangers. a6 id. 36 peterson et al., supra note 31, at 185. 2014 355 indiana health law review panel of medical specialists in fields such as dermatology, pulmonary medicine, and toxicology to provide an analysis . . . [and found that] problems stem from the active ingredient used in these tanning products, a chemical called [dha]."37 precautions such as nose plugs, eye protection, and lip balm may decrease the accidental inhalation or ingestion of dha during spray tan application; however, salons may not offer or advocate for such precautions because of the undesirable "tan lines" that may result from use of precautionary methods. despite possible preventative measures, external application of dha results in absorption by the skin. thus, "[elven though the dha-induced browning of the skin is limited to the outer layer of the [skin] it has been reported that dha is detectable in the blood stream quickly after topical application."38 if dha is absorbed through the skin, it may begin "[circulating in the blood stream, [and] may also be able to affect [deoxyribonucleic acid (dna)] and proteins in other cells of the organism." 39 as there is evidence of harm associated with the absorption of dha through the human skin, spray tanning facilities must be regulated. as early as 1980, a study demonstrated that tanning lotions containing dha caused primary dna damage.40 a similar mutation research study, conducted in 2004, revealed that dha "induces dna damage, cell-cycle block and apoptosis in cultured keratinocytes." 41 alarmingly, "[t]he dha concentrations (up to 100mm) used in this investigation are below those found in commercially 37 levine, supra note 34. 38 peterson et al., supra note 31, at 181-85 ("[t]he low molecular weight of dha (152.1 da) enables its penetration through the skin.") (internal citations omitted). 39 id. at 185. 40 id. at 174. 41 id. at 181-82 (stating that these "results were obtained with a cultured keratinocyte cell line and there is no evidence that dha induces the same biological effects in human epidermis.") ("the timeand dose-dependent decrease in viability and the inhibition of clonal growth suggest a direct toxic effect caused by dha or by age-modified proteins leading to cell death."). 356 vol. 11:1 a plea for consumer protection available sunless tanning lotions (>330mm)." 42 these studies make it clear that further research is necessary to determine whether dha may prove to be detrimental to human health. dha, however, is not the sole component of spray tanning solutions. many sunless tanning products "typically contain 3% to 5% dha, in combination with any number of additional ingredients, including sunscreens, bronzers, vitamins, botanical extracts, antioxidants, and alpha-hydroxy acids." 43 spray tan solution ingredients often include: witch hazel, propellant, preservatives, stabilizer, and more.44 as dha is the primary skin-staining component, it is the most desirable ingredient of sunless tanning products. because nearly all sunless tanning products contain this active ingredient, more research is necessary to thoroughly investigate any potentially harmful consequences associated with dha application, absorption, ingestion, and inhalation. b. dha application approved for external use only color additives are subject to fda regulation. 45 the ffdca authorizes the fda's regulation of color additives and lists dha for use in imparting color to the human body (including sunless tanning products), but dha is restricted to external application. 4 6 the ffdca defines the term "cosmetic" to mean "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, 42 id. at 185. 43 fu et al., supra note 11, at 709. 44 linda tarr kent, spray tanning ingredients, livestrong.com (jan. 2, 2010), http://www.livestrong.com/article/69273-spray-tanningingredients/. 45 "cosmetic products and ingredients are not subject to fda premarket approval authority, with the exception of color additives." u.s. dep't of health and human servs., fda authority over cosmetics, u.s. food and drug admin., http://www.fda.gov/cosmetics/ guidancecomplianceregulatorylnformation/ucm074162.htm (last visited july 6, 2013) ("cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing."). 46 21 c.f.r. §§ 70.3(v), 70.5(a), 73.2150, (2013). 3572014 indiana health law review beautifying, promoting attractiveness, or altering the appearance . . . ." 47 according to the cfr, "externally applied" cosmetics are those "applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane." 48 although spray tans are applied externally, it may be impossible to avoid dha contact with the lips, nose, and areas of the eye during the misting application (an application for which dha has not been approved). thus, when imparted with color in a spray tan booth, consumers are not acting in compliance with fda recommendations. the fda specifically prohibits dha application near the eye. 49 the cfr defines "area of the eye" as "the area enclosed within the circumference of the supra-orbital ridge and the infra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge."5 0 seemingly, current spray tanning practices do not warn consumers of this risk. it is likely that dha has come into contact with the area of the eye of many spray tan consumers, which has been specifically forbidden by the fda. as the risks of such dha exposure are currently unknown and under-investigated, sunless tanning practices should be regulated more thoroughly. c adverse health effects of spray tan application worldwide concerns about the safety of dha in spray applications have flourished due to the possibility of consumer exposure by inhalation, an "exposure . . . quite different from dha as an ingredient in self tanning creams, which occurs via the skin only." 51 early studies were undertaken to investigate the chemical mechanism 47 21 u.s.c. § 321(i)(1) (2013) (effective june 22, 2009). 48 21 c.f.r. § 70.3(v). 49 see id. § 70.5(a). 50 see id. § 70.3(s). 51 european comm'n, supra note 20. 358 vol. 11-1 a plea for consumer protection responsible for staining the skin. 52 a 1960 university of cincinnati college of medicine study found that the combination of dha and arginine, "one of the most important amino acid constituents of human skin . . . is probably responsible for the browning which is observed when human skin is treated with dha." 53 despite the absence of human-based studies, medical professionals suggest that dha may be linked to cancer. 54 concerns about the negative effects of long-term dha exposure are not unwarranted, as "[a]n fda report from 1999 found that, even when not inhaled, dha was reaching deeper skin levels and being absorbed into the body."5 5 even if all proper precautions are taken, dha may still be absorbed through the human skin after a sunless tanning application. the fda has received reports from consumers who have experienced adverse effects associated with spray tanning, including: allergic reactions, rashes, itchiness, inflammation of the hair follicles, dry skin, coughing, dizziness, and fainting.56 further research is necessary to investigate the specific causes of these symptoms. consumers with nut allergies, however, should be particularly cautious of spray tanning. in october of 2012, a fifteen-year-old with a nut allergy, alyssa misemer of platte city, missouri, had a severe allergic reaction to a spray tan solution, and she later said "[right when i found out that . . . the tan had walnut extract in it, i was terrified that i was going to die from it."57 consumer awareness of the ingredients applied 52 eva wittgenstein and helen k. berry, reaction of dihydroxyacetone (dha) with human skin callus and amino compounds, 36 j. invest. dermatol. 283 (1961), available at http://www.nature.com/jid/journal/v36/n4/pdfljidl96146a.pdf (discussing present studies "undertaken to investigate the chemical mechanism responsible for the 'tanning' phenomenon."). 53 id. at 285. 54 sylvia b. hubbard, spray tans linked to lung cancer, newsmax health (aug. 22, 2013, 5:19 pm), http://www.newsmaxhealth.com/headline/spray-tans-fake-tans-lungcancer-dihydroxyacetone/2013/08/22/id/521824. 55 levine, supra note 34. 56 sunless tanners guidance, supra note 24. 57 abby eden, teen says spray tan could have killed her, fox4kc.com (oct. 23, 2012), http://fox4kc.com/2012/10/23/teen-says3592014 indiana health law review during the spray tan process is necessary to avoid foreseeable allergic or adverse reactions. at present, no such procedural or informative requirement exists in the realm of sunless tanning booths. allegations of allergic reactions to spray tanning solutions have even faced the u.s. courts. in 2012, adam kaufman went on trial for the alleged strangulation murder of his wife eleanora kaufman who was found dead in her home in 2007.58 kaufman's defense attorneys argued that the deceased "had applied a spray-on tan earlier that resulted in a violent allergic reaction, causing fatal respiratory failure after she collapsed, her neck draped over the magazine rack." 59 later, the defense attorneys argued, "kaufman's wife died of an undiagnosed heart disease and a fall onto a magazine rack."6 0 kaufman was acquitted in his wife's death because "the jury did not think the state proved its murder case beyond a reasonable doubt." 61 this situation illustrates the potential result of a severe allergic reaction to a spray tan solution and furthers the notion that spray tan solutions should be more thoroughly investigated and regulated to adequately protect innocent and uninformed consumers. d. dha has no regulatory status the national institute of occupational safety and health and the occupational safety and health administration have set no standards or guidelines for spray-tan-could-have-killed-her/ (last visited july 6, 2013) (discussing that misemer had previously been spray tanned at the same salon, but was not alerted to the change in solution during a subsequent application). 58 spray can tan defense colors murder trial, cbs miami (may 5, 2012, 3:30 pm), http://miami.cbslocal.com/2012/05/05/spray-can-tandefense-colors-murder-trial/. 59 ]d. s0 casey glynn, south fla. developer adam kaufman acquitted in wife's 2007 death, cbsnews.com (june 6, 2012, 1:46 pm), http://www.cbsnews.com/8301-504083_162-57448198-504083/south-fladeveloper-adam-kaufman-acquitted-in-wifes-2007-death/. 61 i~d. 360 vol. 11:1 a plea for consumer protection occupational exposure to, or work place allowable levels of, dha. 62 likewise, dha was not on the american conference of governmental industrial hygienists list of compounds for which recommendations for a threshold limit value or biological exposure index are made.63 while the fair packaging and labeling act (fpla) authorizes the fda to require ingredient declarations on products sold to consumers on a retail basis, fpla does not apply to products used exclusively by professionals, such as those used in spray tanning booths. 64 thus, consumers cannot access information about the contents of spray tanning solutions, and may be unable to identify allergens in the substances. iii. initial governmental response to indoor tanning regulation since the 1920s, countless americans have been attentive to maintaining a "healthy" glow. 65 early access to indoor uv tanning devices was virtually unrestricted.6 6 as consumers sought a tanned appearance, the government eventually responded by increasing indoor uv tanning legislation, particularly focused on decreasing youth access.6 7 however, despite the unknown risks associated with long-term exposure to sunless tanning solutions and the lack of investigatory science on the subject, both federal and state governments have failed to adequately regulate the spray tanning industry. this section discusses the history and background of indoor tanning regulation worldwide but focuses on the u.s. 62 dha summary, supra note 13. 63 id. 64 sunless tanners guidance, supra note 24. 65 sheehan & lesher, supra note 2, at 1192. 66 see busayo obayan et al., enacting legislation to restrict youth access to tanning beds: a survey of advocates and sponsoring legislators, 63 j. am. acad. dermatol. 63 (2010) ("between 1998 and 2007 there has been an increase in the attitude that tans enhance appearance and a corresponding increase in the number of tanning facilities, making tanning beds more accessible to youth."). 67 id. 2014 361 indiana health law review a. governmental response to indoor uv tanning regulation of the uv tanning industry has evolved alongside increasing scientific discoveries associated with the risks of uv tanning practices. despite evidence of serious human health hazards related to uv exposure, the u.s. government did not begin to regulate indoor uv tanning until the mid-1970s "due to numerous reported sunlamp related injuries." 68 the american academy of dermatology, the american medical association, the who, and other health organizations have since advocated for anti-tanning policies aimed at consumer protection.69 since 2003, "youth access to indoor tanning has become increasingly restricted throughout the world as accumulating evidence demonstrated an association between melanoma and indoor tanning."70 while the u.s. federal government regulates tanning devices through the fda, 71 it has been unresponsive to efforts for more stringent "regulations of the indoor [uv] tanning industry at the federal level."72 however, a shifted focus by health groups on state and local levels has resulted in further regulation of the indoor uv tanning industry. 73 68 michelle k. pulley, comment, government tan lines: examining the reach and effectiveness of federal and state efforts to protect consumers from the dangers of indoor tanning, 36 pepp. l. rev. 1161, 1171 (2009) (citing 21 c.f.r. § 1040 (2013)). 69 id. at 1178-79 (citing paul vitello, skin cancer up among young, tanning salons become target, new york times, aug. 14, 2006, at b1 http://query.nytimes.com/gst/fullpage.html?res= 9co3e1dc173ef937a2575bcoa9609c8b63 (discussing that health organizations "have labeled tanning beds as the health-peril equivalent of cigarettes.")). 70 as further evidence of the detrimental health effects of uv radiation, a fourteen-year scandinavian study suggested that as "[compared with nonusers of tanning beds, the risk of melanoma was 1.3 times greater for people who used tanning beds for 1 to 10 sessions, 1.8 times greater for people who used tanning beds for 11 to 24 sessions, and 2.7 times greater for people who used tanning beds more than 100 sessions." pawlak, supra note 6, at 1009, 1011. 71 see 21 c.f.r. § 1040.20 (2013). 72 pulley, supra note 68, at 1179 (citing 21 c.f.r. § 1040.20). 73 id. at 1180 (citing jennifer saranow, states crack down on indoor tanning, wall st. j. (jan. 26, 2005), http://online.wsj.com/ 362 vol. 11:1 a plea for consumer protection as of 2008, legislation intended to reduce consumer health risks of indoor tanning facilities had been enacted in twenty-eight u.s. states. 74 a study reporting actual enforcement practices related to indoor tanning laws revealed data indicating, "routine annual inspections, which are a prerequisite for other enforcement activities such as levying penalties for violations, are not conducted in 64% of the cities."7 5 as demonstrated in the american medical association's study, "legislation restricting all minors has a greater impact in reducing youth indoor tanning than legislation requiring only parental consent or parental accompaniment." 76 as of 2011, however, "[1legislation banning access of high-risk groups to sunbeds has only been introduced in a limited number of jurisdictions worldwide, and there is to date only limited evidence available on compliance."77 thus, mere evidence of a legislative response to limit access to indoor uv tanning may not be indicative of its effectiveness. consumer awareness should also be promoted as a means to limit exposure. in 2009, the who "reclassified all forms of sunlamps, tanning beds, and uv light as class 1 carcinogens, which are known to cause cancer in humans."78 in this way, the who enlightened indoor uv tanning consumers of the article/0,,sb110669233656235821,00.html). 74 joni a. mayer et al., enforcement of state indoor tanning laws in the united states, 5 preventing chronic disease, no. 4, 2008, at 1, available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2578791/pdf/pcd54al25. pdf. 75 id. at 3. 76 pawlak, supra note 6, at 1009. 77 jennifer k. makin et al., compliance with age and skin type restrictions following the introduction of indoor tanning legislation in melbourne, australia, 27 photodermatology, photoimmunology, and photomedicine 286, 291 (2011) ("in the united states, compliance with state laws restricting access for minors has been found to be less than optimal, potentially partly due to lack of enforcement."). 78 pawlak, supra note 6, at 1007 (citing position statement on indoor tanning, american academy of dermatology, http://www.aad.org/forms/policies/uploads/ps/psindoor%20tanning%2011-16-09.pdf); salynn boyles, who: tanning beds cause cancer, webmd (july 28, 2009), http://www.webmd.com/ healthy-beauty/news/20090728/who-tanning-beds-cause-cancer. 2014 363 indiana health law review known risks associated with this practice. legislatures also sought to provide enhanced protection to minors. awareness of the human health hazards associated with indoor uv tanning alone was not sufficient to shield adolescents from detrimental decisions.80 specifically, "[t]he number of countries that had nationwide indoor tanning laws for youth [eighteen] years or younger increased from [two] countries (france and brazil) in 2003 to [eleven] countries in 2011."81 in the u.s. alone, the number of states restricting youth access to indoor tanning increased from three states in 2003 to eleven states by 2011.82 of the remaining thirty-nine states, only twenty-one states "require[d] parental consent or accompaniment for tanning bed use" at that time.83 because most of this legislation focuses on the youth, it fails to adequately address issues associated with adult indoor uv tanning practices. one explanation is that legislators believe consumers have been adequately warned of the health risks associated with indoor uv tanning usage, and therefore adult rights should not be infringed. the same should be true for spray tanning practices, but it is not. consumers are not adequately informed of the chemical ingredients in spray tanning solutions, nor are frequent spray-tanners aware of the uninvestigated nature of long-term human exposure to such products. under the ffdca, uv tanning devices are currently regulated by the fda as class i medical devices, the most lightly regulated category. 8 4 perhaps the fda regulates 7 see mayer et al., supra note 74, at 1-5. 80 see id. 81 pawlak, restricting access to indoor tanning, supra note 6, at 1008 ("these [eleven] countries are france, spain, portugal, germany, austria, belgium, england. whales, northern ireland, scotland, and brazil."). 82 id. ("california increased the indoor tanning restriction to youth [eighteen] years or younger and became the first state in the united states to restrict indoor tanning to all minors."). 8 3 id. 84 staff of u.s. house of representatives comm. on energy and commerce, 112th cong., false and misleading health information provided to teens by the indoor tanning industry: investigative report 7 (2012), available at 364 vol. 11:1 a plea for consumer protection this known carcinogen in the least stringent medical device category to avoid infringing upon consumers' freedom of choice; however, it seems that such devices should be more rigorously regulated as uv exposure carries a multitude of dangerous health risks. uv tanning beds "are subject to fda's general controls for medical devices (including rules about good manufacturing practices, recordkeeping, reporting, adulteration, and misbranding) and performance standards specific to tanning beds."85 these standards may not be enough to adequately protect consumers from the potential harms of this known carcinogen. b. governmental response to indoor sunless tanning there is no federal-level regulation of the spray tanning industry. the fda maintains, "firms and individuals who market cosmetics are responsible for assuring that the products they market are safe when used under labeled or customary conditions of use."86 however, tanning salons are not effectively regulating spray tanning products, as the "vast majority of tanning salons contacted by committee investigators provided false information about the serious risks of indoor tanning and made suspicious claims about the health benefits that indoor tanning provides."8 7 while legislation was enacted to restrict indoor uv tanning throughout the world, the same has not been done for its sunless counterpart despite the unknown risks associated with human exposure to (and absorption of) spray tanning solutions. http://democrats.energycommerce.house.gov/sites/default/files/document s/false-health-info-by-indoor-tanning-industry-2012-21.pdf [hereinafter us. house of representatives investigative repor] (discussing the limited federal oversight attributed to class i devices including band-aids, rubber gloves, and tongue depressors, which present minimal potential harm to the user);_21 u.s.c. § 360c (2013) (effective july 9, 2012). 85 us. house of representatives investigative report, supra note 84, at 7 (citing 21 u.s.c. §360c(a)(1)(b) (2013) (effective july 9, 2012)). 86 sunless tanners guidance, supra note 24. 87 us. house of representatives investigative report, supra note 84, at 2. 2014 365 indiana health law review iv. current indoor tanning regulations this section discusses current indoor tanning regulation in more detail, and it examines both federal and state regulation pertaining to the indoor tanning industry. in particular, this section highlights the differences between the regulation of indoor uv tanning and indoor spray tanning and suggests that more stringent regulations should be enacted to adequately protect consumers from the potential harms associated with indoor spray tanning practices. this section further suggests that additional research is necessary to determine whether spray tanning booths should be approved by the fda, and it seeks to encourage enhanced consumer knowledge and protection concerning sunless tanning solutions, ingredients, and uninvestigated human health hazards. a. federal indoor tanning regulations in response to the growing concern about the long-term health risks associated with indoor tanning practices,88 the fda initially promulgated indoor tanning regulations over three decades ago; however, federal regulation of the indoor tanning industry has since expanded.8 9 while the majority of current indoor tanning regulation exists at the state 88 pawlak, supra note 6, at 1006 ("long-term health risks of indoor tanning are premature aging, immune suppression, cataract and other eye injuries, and skin cancers. skin cancer is the most common cancer in the united states, and approximately [twenty-percent] of americans will develop skin cancer in their lifetime.") (internal citations omitted). 89 see sunlamp products performance standard, 42 fed. reg. 65,189, 65,189 (dec. 30, 1977) (codified at 21 c.f.r. § 1040.20 (2013) (effective april 22, 2010); but see eric conroy, master sunshine: the overzealous war on indoor tanning, slate (may 13, 2006, 7:47 am et), http://www.slate.com/articles/healthandscience/humannaturel 2006/05/master sunshine.single.html#pagebreakanchor_2 (without guidance, technology can be dangerous, and it has been predicted that "[ilt won't be congress that stops teens from cooking their skin. it'll be tanning sprays and lotions, which continue to improve in appearance, durability, and popularity. and guess who's going to lead the way? salons."). vol. 11:1366 a plea for consumer protection level, 90 the federal government nevertheless plays an important role in protecting consumers. this sub-section highlights the important federal regulations pertaining to the tanning industry. it delves into the protections (or lack thereof) afforded to tanning consumers, including a discussion of the ffdca's regulation of tanning devices and the federal trade commission's (ftc) regulation of tanning advertisements. 91 in addition, this sub-section addresses the following key concerns: the lack of consumer awareness and the effectiveness of the imposition of tanning taxes. 1. the fda: regulating color additives and tanning devices under the ffdca the fda's legal authority over cosmetics is different from other products regulated by the agency. cosmetic products and ingredients are not subject to fda premarket approval authority, with the exception of color additives. 92 the fda regulates the color additive dha as an external cosmetic product. 93 the fda requires that dha "be safely used in amounts consistent with good manufacturing practice in externally applied drugs intended solely or in part to impart a color to the human body." 94 dha must also conform to identity and specification limitations required by the fda.95 however, "[certification of this color additive, [dha1, is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act." 9 6 90 see infra section iv.b. 91 see 15 u.s.c. § 41 (2013) (effective may 24, 1950). 92 sunless tanners guidance, supra note 24. 93 21 c.f.r. § 70.3v (2013); id. § 73.2150 (as a cosmetic product, dha must be "applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane."). 94 see id. § 73.1150(c). 9 see id. § 73.1150(a), (b). 96 see id. § 73.1150(e); see also sunless tanners guidance, supra note 24 ("[r]egulations listing dha as a color additive also require it to meet tight specifications, with strict limitations on impurities."); see 21 c.f.r. § 73.1150. 2014 367 indiana health law review because safety data to support the use of dha in spray tanning facilities has not been submitted to the fda for review and evaluation, "the use of dha in 'tanning' booths as an all-over spray has not been approved by the fda."97 although this statement is available on the fda's website, it may not be largely known by consumers in the u.s. and worldwide. thus, it is important for federal and state governments, as well as national and local health authorities, to adequately inform the public of the unknown risks associated with regular spray tanning booth use. under the ffdca, uv tanning beds and tanning lamps are regulated as medical devices. 98 as defined within the ffdca, the term "device" includes any instrument that is "intended to affect the structure or any function of the body of man . . . ."99 because the uv rays emitted from the tanning bed lamps alter the human skin by producing a tan, indoor uv tanning devices necessarily fall within this definition. likewise, under the electronic product radiation control provisions of the ffdca, the fda maintains the authority to regulate uv tanning devices as radiationemitting medical electronic products.100 for purposes of radiological health, the fda sets the performance standards for light-emitting products, including "[slunlamp products and [uv] lamps intended for use in sunlamp products."101 the fda regulation of uv tanning devices involves performance standards, irradiance ratio limits, a timer system, control for termination of radiation emission, safety precautions such as the use of protective eyewear, label requirements, instructions to be provided to users, and compliance tests.10 2 much of the 97 sunless tanners guidance, supra note 24. 98 21 u.s.c. § 321(h) (2013) (effective june 22, 2009). 9 see id. § 321(h)(3). 100 u.s. dep't of health and human servs., radiation-emitting products: summary of the electronic product radiation control provisions of the federal food, drug, and cosmetic act, u.s. food and drug admin., http://www.fda.gov/radiation-emittingproducts/ electronicproductradiationcontrolprogram/lawsandregulationsucm 181 56.htm (last updated mar. 1, 2010); 21 u.s.c. §§ 360hh-360ss. 101 21 c.f.r. §1040.20. 102 id. 368 vol. 11:1 a plea for consumer protection fda's regulation of uv tanning devices focuses upon the "[11abels for sunlamp products," which must contain: a warning statement, recommended exposure positions, directions for achieving the recommended exposure, a recommended exposure schedule, a timeframe of expected results, and a designation of the uv lamp within the product. 103 uv lamps must have "a label which contains: [t]he words sunlamp--danger--ultraviolet radiation. follow instructions." 104 all uv tanning device labels must meet stringent specifications whereby any label "shall be permanently affixed or inscribed on an exterior surface of the product . . . so as to be legible and readily accessible to view by the person being exposed immediately before the use of the product."10 5 under the ffdca, the fda must classify "devices intended for human use" in one of three categories. 106 class i devices are subject to general controls, whereas class ii devices are subject to special controls and 103 see id. §1040.20(d)(1)(i)-(vi). the warning statement must include the following: danger-ultraviolet radiation. follow instructions. avoid overexposure. as with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. repeated exposure may cause premature aging of the skin and skin cancer. wear protective eyewear; failure to may result in severe burns or long-term injury to the eyes. medications or cosmetics may increase your sensitivity to the ultraviolet radiation. consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. if you do not tan in the sun, you are unlikely to tan from the use of this product. id. §1040.20(d)(1)(i). 104 see id. §1040.20(d)(2)(i) . uv lamp labels must also include the model identification as well as the words "[ulse only in fixture equipped with a timer." id. §1040.20(d)(2)(ii)-(iii). 105 see id. §1040.20(d)(3)(i). 106 21 u.s.c. § 360c (2013) (effective july 9, 2012). 2014 369 indiana health law review cannot be classified as a [c]lass i device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is insufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines . . . recommendations, and other appropriate actions ... 107 class iii devices require premarket approval because "insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device," and because "insufficient information exists to determine that the special controls described in subparagraph (b) would provide reasonable assurance of its safety and effectiveness." 0 furthermore, class iii devices are either "purported or represented to be for a use in supporting or sustaining human life" or "presents a potential unreasonable risk of illness or injury."0 9 indoor ujv tanning devices are regulated under section 201(h)(3) of the ffdca as class i medical devices, the least stringent regulatory category.110 at present, spray tanning devices are not regulated under the ffdca. while it is within the fda's authority to regulate the performance standards of uv tanning devices, the fda is also authorized by the ffdca to restrict the sale, distribution, or use of any such device."' because of a device's "potentiality for harmful effect or the collateral measures necessary to its use," and if "there cannot otherwise be reasonable assurance of its safety and 107 see id. § 360c(b). 108 see id. § 360c(c)(i). 109 see id. § 360c(c)(ii)(i)-(ii). 110 21 c.f.r. § 878.4635. 111 21 u.s.c. § 360j(e). 370 vol. 11:1 a plea for consumer protection effectiveness," the fda may restrict the use of a device through regulation.112 similarly, the ffdca gives the fda the authority to ban a device intended for human use if it "presents substantial deception or an unreasonable and substantial risk of illness or injury."113 because it is within the fda's power to regulate, restrict, and ban any device regulated within the ffdca, the fda may consequently regulate uv tanning beds. unlike the uv tanning devices regulated under the ffdca as class i medical devices, the fda does not regulate spray tanning devices. the fda merely cautions consumers against the use of spray tanning booths on its website.114 nevertheless, the fda requires "[t]he labeling of suntanning preparations that do not contain a sunscreen ingredient." 115 the cfr defines the term "suntanning preparations" to include: gels, creams, liquids, and other topical products that are intended to provide cosmetic effects on the skin . . . or to give the appearance of a tan by imparting color to the skin through the application of approved color additives (e.g., dihydroxyacetone) without the need for exposure to uv radiation.116 although sunless tanning products and spray tanning devices must contain appropriate warnings as required by the fda, there is no current federal regulation of spray tanning booths or the solutions emitted therefrom. instead, the fda advises consumers to ask several "questions when considering commercial facilities where dha is applied by spraying or misting."117 according to the fda, if consumers are not sheltered from dha exposure 112 see id. § 360j(e)(1)(b). 113 see id. § 360f(a)(1). 114 sunless tanners guidance, supra note 24. 115 21 c.f.r. § 740.19. 116 id. 117 sunless tanners guidance, supra note 24. 2014 371 indiana health law review in the entire area of the eyes, in addition to the eyes themselves, . . . the lips and all parts of the body covered by mucous membrane,... [and] internal exposure caused by inhaling or ingesting the product . . . the consumer is not protected from the unapproved use of this color additive.118 the fda instead places the responsibility for the safety of spray tanning booths on salons as well as state and local health authorities.119 although spray tanning booths have not been authorized for consumer use, the fda suggests that consumers may safely apply sunless tanning products sold in retail stores (such as creams and lotions) because "dha is approved for external application to the human body, which is the way these products are intended to be used."120 since dha is approved by the fda to impart color to the human body in specified methods and not as an all-over spray, confusion may arise amongst consumers as to the safety of sunless tanning products. countless consumers may be operating under the assumption that because the fda has approved dha under limited circumstances, it must be safe to utilize spray tanning booths. due to consumer confusion and the possibility of unknown health risks associated with dha exposure, more stringent regulations must be established to protect and educate the general public, consumers, and salon professionals. 2. the ftc: regulating advertising claims by the indoor tanning industry while the fda regulates uv tanning devices and color additives, the ftc regulates "the content of advertising 118 id. 119 id. 120 id. ("consumers can easily avoid inhaling [dha-containing creams or lotions] or applying them to the area of the eye or mucous membrane."). 372 vol. 11:1 a plea for consumer protection claims made by the indoor tanning industry."121 under the federal trade commission act (ftca), the ftc has the authority to regulate advertising in general. 122 the ftca mandates, "[aidvertising must be truthful and nondeceptive; [a]dvertisers must have evidence to back up their claims; and [a]dvertisements cannot be unfair." 123 according to a 1983 ftc policy statement on deception, an advertisement is unlawfully deceptive if it contains a statement or omits information that "[ils likely to mislead consumers acting reasonably under the circumstances; and [ils 'material' that is, important to a consumer's decision to buy or use the product." 124 specifically, the ftca prohibits "any person, partnership, or corporation to disseminate, or cause to be disseminated, any false advertisement." 12 5 it is unlawful to falsely advertise "ibly any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase in or having an effect upon commerce, of food, drugs, devices, services, or cosmetics." 126 sunless tanning industry advertisements are subject to ftc regulation under the ftca. because the ftc pays closest attention to advertisements "that make claims about health or safety" or "that make claims that consumers would have trouble evaluating for themselves," the ftc implies that it more stringently monitors advertisements made by the tanning industry. 127 in fact, when the indoor tanning association (ita) "launched an advertising campaign designed to 121 pulley, supra note 68, at 1183; see federal trade commission act of 1950 (ftca), 15 u.s.c. §§ 41-52 (2013) (effective may 24, 1950). 122 federal trade commission act of 1950 (ftca), 15 u.s.c. §§ 4152. 123 bureau of consumer prot. bus. ctr., advertising faq's: a guide for small businesses, federal trade commission (apr. 2001), http://business.ftc.gov/documents/bus35-advertising-faqs-guide-smallbusiness; see pulley, supra note 68, at 1187 (discussing the ftc regulating advertising claims by the indoor uv tanning industry). 124 pulley, supra note 68, at 1187 (citing ftc policy statement on deception (oct. 14, 1983), http://www.ftc.gov/bcp/policystmt/addecept.htm). 125 15 u.s.c. § 52(a). 126 id. § 52(a)(2). 127 bureau of consumer prot. bus. ctr., supra note 123. 3732014 indiana health law review portray indoor tanning as safe and beneficial" in march of 2008, the ftc charged the ita "with making false health and safety claims about indoor tanning."128 the subsequent 2010 settlement agreement between the ftc and the ita prohibits the ita from making misrepresentations about the indoor tanning industry, from misrepresenting any tests and studies, from providing deceptive advertisements to members, and it also "requires that future association ads that make safety or health benefits claims for indoor tanning may not be misleading and must be substantiated." 129 likewise, to increase consumer awareness of the myths and reality of uv tanning, the ftc published consumer information regarding the uv tanning industry in january of 2010.130 while the ftc purports to investigate "false, misleading, and deceptive advertising claims about [tanning] devices," it makes no mention of regulating spray tanning advertisements. 131 ftc regulation has afforded some consumer protection by disallowing unsubstantiated health and safety claims about indoor uv tanning. for this reason, the ftc should also regulate sunless tanning industry advertisements. because "[no u.s. government agency recommends the use of indoor tanning equipment," the ftc must further seek to dispel the notion that wv or sunless indoor tanning has been "approved by the government." 132 as advertisements so greatly affect consumers' opinions about appearance and skin color, the ftc must help to protect consumers from the potential harms associated with frequent indoor sunless tanning use 128 indoor tanning association settles ftc charges that it deceived consumers about skin cancer risks from tanning, federal trade commission (jan. 26, 2010), http://www.ftc.gov/opa/2010/01/ tanning.shtm. 129 id. 130 consumer information: indoor tanning, federal trade commission (jan. 2010), http://www.consumer.ftc.gov/articles/0129indoor-tanning (dispelling false claims commonly made about indoor uv tanning). 131 id. 132 id. 374 vol. 11: 1 a plea for consumer protection unless or until the safety of spray tanning devices is substantiated. 3. tanning accountability and notification act of 2007 (tanact) as part of the food and drug administration amendments act, the tanning accountability and notification act of 2007 (tan act) mandated that the fda review the warning labels affixed to indoor tanning equipment.133 the tan act directs the fda to continue to determine whether tanning bed labels effectively inform consumers about the risks associated with frequent use, and if considered ineffective, to reconsider the label language.134 the tan act also provides significant benefits for the development and use of medical products and ensures that the fda will have the resources necessary to conduct comprehensive new device reviews.135 in compliance with the tan act and after determining that the current labels for indoor tanning devices did not effectively communicate the risks associated with indoor tanning, the fda reported such findings to congress in december of 2008.136 to limit both the amount of uv rays emitted by tanning beds and the amount of consumer exposure time, u.s. house representative carolyn maloney (d-ny) introduced the "tanning bed cancer control act of 2011" (tbcca). 137 the tbcca was undoubtedly a response to the fda findings following the enactment of the 133 food and drug administration amendments act of 2007, pub. l. no. 110-085, 121 stat. 823 (codified as amended in scattered sections of 21 u.s.c. § 301; u.s. dep't of health and human servs., regulatory information: food and drug administration amendments act (fdaaa) of2007, u.s. food and drug admin., http://www.fda.gov/ regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/s ignificantamendmentstothefdcact/foodanddrugadministrationamendme ntsactof2007/default.htm [hereinafter fdaaa regulatory information] (last visited aug. 25, 2013). 134 see knapp, supra note 10, at 30 (citing 121 stat. 823). 135 fdaaa regulatory information, supra note 133. 136 tanning bed cancer control act of 2011, h.r. 1676, 112th cong. (2011). 137 id. 3752014 376 indiana health law review vol. 11:1 tan act "to help prevent the occurrence of skin cancer resulting from the routine use of uv tanning lamps by imposing more stringent controls on the use of such devices."138 the tbcca proposes to complete a study on the performance standards established under the ffdca for uv tanning lamps to examine the effectiveness of such standards, 139 and to revise such performance standards and labeling of uv tanning devices as necessary following the study. 140 though not yet enacted, the tbcca more effectively protects consumers from the harms of uvemitting tanning beds. 4. tanning tax while the patient protection and affordable care act imposes a tax of ten percent on the amount paid for tanning services (effective july 1, 2010), the use of spray tanning devices is not included in this taxation scheme. 141 under the internal revenue code, the ten percent tax applies only to any indoor tanning services "employing any electronic product designed to incorporate [one (1)] or more [uv] lamps and intended for the irradiation of an individual by [uv] radiations, with wavelengths in air between 200 and 400 nanometers, to induce skin tanning."14 2 perhaps as knowledge increases about the uninvestigated effects of frequent spray tanning on the human body, this tanning tax will be extended to spray tanning devices as well. if the government finds the tanning tax to be lucrative, it may 138 id. 139 21 u.s.c. § 360d (2013) effective july 9, 2012). 140 h.r. 1676. 141 patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010) (codified at 42 u.s.c. § 18001 (2010)); see knapp, supra note 10, at 31-32 (discussing the imposition of a tanning tax on indoor uv tanning salons and comparing it to "[t]he data on the effectiveness of the cigarette tax [which] supports the argument that sin taxes reduce activity levels.") (citing ann boonn, raising cigarette taxes reduces smoking, especially among kids (and the cigarette companies know it), campaign for tobacco-free kids (oct. 11, 2012), http://www.tobaccofreekids.org/research/factsheets/pdf/0146.pdf). 142 26 u.s.c. § 5000b(b)(1) (2013). a plea for consumer protection extend the tax to spray tanning simply to increase revenue. though a tanning tax may not lead directly to greater consumer protection, the added cost may deter some consumers from tanning and may assist the government in funding tanning regulation programs. 14 3 nevertheless, if the tanning tax is absorbed by the industry and is not passed on to the customers, "it is unlikely to dissuade frequent tanners or result in a scarcity of tanning, [and] the tax by itself is unlikely to substantially reduce activity levels."144 b. state tanning regulations while a federal-level regulatory scheme on indoor tanning would likely have the most far-reaching impact, in the absence of federal oversight current indoor tanning legislation is primarily drafted and enforced by each state. 145 apprehensive about the lack of federal regulation, many state legislatures have enacted tanning regulations pertaining to a number of areas including equipment standards, facility-related regulations, enforcement issues, and access to tanning services. 146 although tanning regulations vary by state, these consumer protections reflect a restrictive trend on the use of indoor tanning by minors. 147 143 pulley, supra note 68, at 1222 (discussing a tanning tax as a possible alternative to traditional indoor tanning regulation). 144 knapp, supra note 10, at 32. 145 lucy l. chen & steven q. wang, post-california tanning ban: a brief updated on current youth access laws, 148 arch. dermatol. 1071, 1071 (2012). 146 id. 147 2013 indoor tanning legislation: 2013 state by state comparison, aim at melanoma, http://www.aimatmelanoma.org/en/ aim-for-a-cure/legislative-accomplishments-in-melanoma/2013-indoortanning.html (last updated aug. 2013) [hereinafter 2013 state comparison: indoor tanning legislation] (describing state bills and listing state law indoor tanning restrictions for minors); indoor tanning restrictions for minors a state-by-state comparison, nat'l conf. of st. legislatures, http://www.ncsl.org/issues-research/health/indoortanning-restrictions.aspx (last updated aug. 2013) [hereinafter tanning restrictions for minors: state comparison] (listing indoor tanning regulations for beds, booths, and sunlamps). 2014 377 indiana health law review this subsection highlights the important state regulations relating to the indoor tanning industry, and it elaborates on state uv tanning regulations in addition to state spray tanning regulations by comparing the state protections afforded to tanning consumers. in addition, this subsection addresses indiana's efforts to protect minors from spray tanning practices. 1. state indoor uv tanning regulations a majority of the states regulate the indoor tanning industry beyond the minimal federal regulations, applying specific prohibitions on uv tanning bed usage. 148 while thirty-two states regulate indoor uv tanning for minors, 149 148 2013 state comparison: indoor tanning legislation, supra note 147 (listing thirty-four state statutes restricting indoor tanning for minors and fourteen state bill descriptions); tanning restrictions for minors: state comparison, supra note 147 (listing thirteen states that have introduced indoor tanning legislation in 2013). 149 see ariz. admin. code § r12-1-1414(a)(2) (2013) (tanning equipment operators); ark. code ann. § 20-27-2202 (2009) (consent required); cal. bus. and prof. code § 22706(b)(3) (2013) (operating regulations; customer acknowledgement of warnings; use of facilities by minors); conn. gen. stat. § 19a-232 (2012) (parental consent for minors); del. code ann. tit. 16, § 3003d (2013) (restrictions on use by minors); fla. stat. § 381.89(7) (2013) (regulation of tanning facilities); ga. code ann. § 31-38-8(b) (2013) (use of tanning equipment by minors); ill. admin. code tit. 77, § 795.190(c) (2013) (records); ind. code § 25-8-15.4-15, -16 (2013) (presence of parent or guardian; signature of parent or guardian on written statement); ky. rev. stat. ann. § 217.922 (west 2013) (consent required for minor using tanning device or facility); la. rev. stat. ann. § 40:2714(e) (2013) (information provided to consumer); 10-144 dept. of human services ch. 223 12a(3)(f) (effective mar. 1, 1991) (rules relating to tanning facilities); md. code ann., health-gen. § 20-106 (effective oct. 1, 2008) (use of tanning facilities by minors); mass. gen. laws ch. 111, § 211 (2013) (minors; parental consent; accompaniment by parent or guardian); mich. comp. laws § 333.13405(2) (effective dec. 23, 2008) (use of tanning devices); minn. stat. § 325h.08 (2012) (consent required); miss. code ann. § 41-115-1 (2013) (use of tanning facilities by minor; parental presence; and consent); n.h. rev. stat. ann. § 313-a:31 (2013) (tanning of minors); n.j. stat. ann. § 26:2d-82.1 (effective june 29, 2012) (minors, prohibitions and restrictions upon facility usage, penalties); n.y. public health law § 3555 (consol. 2013) (restrictions vol. 11:1378 a plea for consumer protection only eighteen states "require operators to limit exposure time to manufacturers' recommendations and provide eye protection." 150 nonetheless, countless individuals, both minors and adults, continue to frequent tanning salons and the american cancer society "estimates 76,000 new cases and nearly 9,200 deaths from melanoma in 2012."1s5 on january 1, 2012, california responded to the growing concern of the harmful effects of regular uv exposure to the human body, acting as the first state in the nation to ban use of uv indoor tanning beds for all minors less than eighteen years of age. 152 other states have since banned the use of indoor v tanning beds by children under the age of fourteen.153 some states have responded by requiring parental accompaniment for minors to use uv tanning on the use of uv radiation devices); n.c. gen. stat. § 104e-9.1(a)(2) (2013) (restrictions on use and operation of tanning equipment); n.d. cent. code § 23-39-05(1)(a) (effective aug. 1, 2007) (duties); ohio admin. code § 4713-19-09 (2013) (records keeping); or. admin. r. 333119-0090(2) (2013) (protection of consumers); r.i. gen. laws § 23-684(6) (effective jan. 1, 2013) (safety standards established); tenn. code ann. § 68-117-104(b)(3) (2013) (duties); tex. health & safety code ann. § 145.008 (west 2013) (operational requirements); utah code ann. § 26-15-13 (west 2013) (regulation of tanning facilities); vt. stat. ann. tit. 18, § 1513(c) (effective july 1, 2012) (tanning facilities, minors, penalty); va. code ann. §59.1-310.3(b) (effective july 1, 2007) (notice to customer, liability); wis. stat. § 255.08 (2013) (tanning facilities); wyo. stat. ann. § 14-3-108 (2013) (effective july 1, 2010) (use of uv tanning devices by persons who have not reached the age of majority). 150 tanning restrictions for minors: state comparison, supra note 147. 151 id. 152 cal. bus. & prof. code §§ 22706, 2241.3 (2013) (effective jan. 1, 2012). vermont was the second state to pass similar legislation banning the use of uv tanning beds by minors under eighteen, which subjects tanning facilities and operators to civil penalties up to $500.00 per offense. see chen & wang, supra note 145, at 1071 (discussing the current status of tanning access restrictions and describing the challenges in the legislative path to "ban the tan."). 153 2013 state comparison: indoor tanning legislation, supra note 147 (listing delaware, georgia, illinois, maine, new jersey, new york (prohibiting minors under seventeen), north carolina (prohibiting children under thirteen), texas (prohibiting minors under sixteen-anda-half), vermont (prohibiting minors under eighteen), and wyoming (banning anyone under sixteen) as prohibiting children under fourteen from using uv tanning beds). 2014 379 indiana health law review beds, 154 while other states mandate written parental permission. 155 most states, however, employ mixed or multiple ljv tanning restrictions on minors but have no such restrictions for adults aged eighteen and above. 156 in fact, arizona goes so far as to require that public schools educate minors about the risks of developing skin cancer.157 though no uniform indoor tanning legislation has been adopted amongst the states, 58 some states have enacted gap-filling statutes to regulate aspects of uv tanning not covered by the fda or the ftc.159 state efforts to regulate 154 id. (citing florida, indiana, kentucky, louisiana, maine, massachusetts, michigan, mississippi, new hampshire, north dakota, tennessee, utah, and wyoming as states that require parental or guardian accompaniment for minors under a certain age (generally thirteen to eighteen) to utilize indoor uv tanning beds). 155 id. (citing arkansas, arizona, connecticut, delaware, florida, georgia, illinois, indiana, kentucky, louisiana, maine, maryland, massachusetts, michigan, minnesota, mississippi, new hampshire, new jersey, north carolina, north dakota, ohio, oregon, rhode island, south carolina, tennessee, texas, utah, virginia, and wyoming as requiring written parental or guardian consent authorizing the minor to use uv tanning beds). 156 tanning restrictions for minors state comparison, supra note 147 (listing delaware, florida, illinois, indiana, kentucky, louisiana, maine, massachusetts, mississippi, new hampshire, new jersey, new york, north carolina, north dakota, rhode island, tennessee, texas, utah, and wyoming as employing a combination of uv tanning restrictions on minors). 157 ariz. rev. stat. ann. § 15-718 (2012) ("all public schools shall incorporate instruction into the existing curricula in the common school grades on skin cancer prevention . . . ."); see tanning restrictions for minors: state comparison, supra note 147. 158 tanning restrictions for minors. state comparison, supra note 147 (while some states have banned indoor uv tanning for minors of varying ages, others require parental accompaniment, parental permission, or impose no known state-wide restriction at all); see supra note 157. 159 some states regulate the business aspects of indoor tanning, such as licensing, initial and annual fees, sanitation guidelines, inspections, record-keeping standards, and more. see, e.g., fla. admin. code ann. r. 64e-17.004 (2013) (operation and training); id. r. 64e17.005 (sanitation); id. r. 64e-17.006 (license and fees); id. r. 64e17.007 (inspection, enforcement, and penalties); see ind. code § 25-815.4-5 (2013) (necessity for license); id. § 25-8-15.4-6 (license requirements); id. § 25-8-15.4-7 (contents of license application); id. § vol. 11:1380 a plea for consumer protection the tanning industry include mandated training for tanning bed operators, 160 written notice and other warning requirements, 16 1 and implementation of penalties for noncompliance. 162 nevertheless, challenges still remain and despite this progress, the current legislation is not strong enough to protect consumers from the dangers of tanning.163 although a majority of the states have sought to enhance consumer protection, salon compliance and consumer awareness have been difficult, as tanning regulations vary by state and may be hard to locate. 164 whether the protections afforded by state-level regulations are aimed at protecting consumers, reducing incidents of skin cancer, or making indoor uv tanning safer, these efforts will only be effective to the extent of regulatory compliance.165 the lack 25-8-15.4-14 (duties of operator); id. § 25-8-15.4-17 (protective eyewear); id. § 25-8-15.4-19 (inspections); id. § 25-8-15.4-24 (civil penalties); 820 ind. admin. code § 5-1-32 (2013) (record-keeping requirements); see pulley, supra note 68, at 1190-98 (discussing that "[m]any states also regulate indoor [uv] tanning in areas that are not covered by the fda or the ftc."). 160 see fla. admin. code. ann. r. 64e-17.003 (2009); 210 ill. comp. stat. 145/25 (2012); ill. admin. code tit. 77 § 795.180 (2013); 820 ind. admin. code 5-1-34 (2013); or. admin. r. 333-119-0080(1), (3) (2012); tenn. code § 68-117-104(a)(1) (2011); va. code § 59.1-310.5(a) (2013) (effective july 1, 2007)); see pulley, supra note 68, at 1194. 161 pulley, supra note 68, at 1194 ("this requirement is different from the fda warning requirement because that warning requirement only applies to labels affixed on the tanning devices.") (citing 21 c.f.r. § 1040.20(d) (2008); cal. bus. & prof. code § 22706 (2012); fla. stat. ann. § 381.89(4)(a) (west 2004); ill comp. stat. ann. 145/25(f) (west 2007); iowa code ann. § 136d.4.2 (west 2007); tex. health & safety code ann. § 145.005(a)(1)-(7) (west 2001)). 162 id. at 1195 (citing cal. bus. & prof. code § 22708 (2005); fla. stat. ann. § 381.89(9)-(10) (west 2004); iowa code ann. § 136d.8 (2012); kan. stat. ann. § 65-1925(d) (west 2013); wis. stat. ann. § 255.08(13)-(15) (west 2013)); see chen & wang, supra note 145, at 1071 ("the legislation pertains to a number of areas, such as equipment standards, facility and operator-related regulations, enforcement and legal issues, and minors' access to tanning services."). 163 chen & wang, supra note 145, at 1071 (internal citation omitted). 164 see 2013 state comparison: indoor tanning legislation, supra note 147. 165 pulley, supra note 68, at 1197 (discussing issues with state-level indoor uv tanning regulations). 2014 381 indiana health law review of uniform enforcement within the states, with "low rates of citations and inspections contributing to noncompliance," must be improved for the regulations to function. 166 effective tanning bed legislation must be enacted, enforced, and incrementally implemented to protect consumers by reducing exposure to uv light and incidents of melanoma. 167 2. state indoor spray tanning regulations there is a lack of both state and federal oversight of the sunless tanning industry, with no regulation of spray tanning booths.1 6 8 although the federal government has addressed safety issues associated with uv tanning bed use, it places the burden on the states to more effectively protect consumers through state-level regulation. 169 likewise, the fda has explicitly passed the burden on to state and local health authorities to regulate spray tanning facilities.o70 while the fda retains the authority to take action against firms and individuals who violate the law, the fda maintains "it is generally the responsibility of local and state health authorities" to monitor the practice of administering cosmetic products, including the use of spray tanning booths, by professionals. 1 71 for this reason, the development of uniform indoor tanning industry guidelines regarding unapproved exposures to spray tanning products should be a priority for the states in protecting consumers 166 chen & wang, supra note 145, at 1071. 167 obayan, supra note 66, at 63 ("barriers to [the] passage of tanning bed legislation can potentially be surmounted with advice to advocates and coordinated efforts by multiple organizations."). 168 fu et al., supra note 11, at 710 ("despite this lack of federal or state oversight . . . the national tanning training institute has begun to advertise a sunless tanning certification course.") (internal citation omitted). 169 see supra section iv. b. 1. 170 fu et al., supra note 11, at 710 ("[n]o formal federal guidelines have been issued regarding the regulation of commercial establishments that offer sunless tanning booth services."). 171 sunless tanners guidance, supra note 24. vol. 11:1382 a plea for consumer protection from the uninvestigated effects of continued exposure to sunless tanning solutions. consumers generally perceive spray tanning as a safer method of achieving a tanned appearance. 172 nevertheless, no long-term human studies have been conducted to examine the health effects of frequent spray tan exposure. 173 for this reason, states should enact spray tanning legislation adding protective provisions to the already-existing indoor uv tanning bed regulations. 174 before continued endorsements are made of the spray tanning booth, further investigations are needed to evaluate the safety and health implications of continued human use. until such time, the states must take action and regulate this industry to adequately protect consumers from the unknown, under-investigated effects of regular spray tan exposure. 3. indiana spray tanning regulations indiana has imposed statutory authority over operators of indoor tanning facilities limited to the regulation of uv tanning products.175 as defined within the indiana code, a "tanning device" does not presently include a spray tanning booth. 176 while the indiana code mentions the use of protective eyewear, it does not discuss nose plugs or other protective measures that would be useful during spray tan application. 177 indiana, however, is one of the first states to attempt to establish regulations for the use of sunless 172 vilma e. cokkinides et al., use of sunless tanning products among adolescents aged 11 to 18 years, 146 arch. dermatol. 987, 991 (2010) ("[t]his study found that approximately [one] in [ten] us adolescents uses sunless tanning products and that many users perceive sunless tanning as a safer way to tan than suntanning or indoor tanning."). an "increased awareness of the medical and cosmetic effects of uv radiation coupled with improved sunless tanning products are promoting the rapid growth of a sunless tanning industry." fu et al., supra note 11, at 706. 173 levine, supra note 34. 174 see, e.g., supra note 154. 175 ind. code §§ 25-8-15.4-125-8-15.4-3 (2013). 176 id. § 25-8-15.4-3. 177 id. § 25-8-15.4-17. 2014 383 indiana health law review tanning booths by minors. 178 conversely, some states specifically exclude the regulation of spray tan application.179 indiana house bill 1115 was introduced on january 6, 2012 requiring anyone under eighteen to have the written approval of a parent or guardian to be spray-tanned. 180 the votes have not yet been cast on this bill.181 this legislation is much like the current indiana law that requires parental 178 h.r. 1115, 117th gen. assemb., 2d reg. sess. (ind. 2012), available at http://www.in.gov/legislative/bills/2012/in/in1115.1.html (proposing to amend ind. code § 24-4-18 to include spray tanning regulations for minors); see, e.g., s. 2119, 214th leg.., 2d ann. sess. (n.j. 2010), available athttp://www.njleg.state.nj.us/2010/bills/s2500/ 2119_ii.htm ("persons between 14 and 18 shall not be permitted to use spray tanning in this facility without written authorization of a parent or legal guardian."). 179 ariz. rev. stat. ann. § 32-506(12) (2013) (effective aug. 2, 2012) ("this chapter does not apply to the following persons while in the proper discharge of their professional duties... [plersons who provide tanning services by means of airbrushing, tanning beds or spray tanning."); neb. rev. stat. § 38-1075(11) (2012) ("the cosmetology, electrology, esthetics, nail technology, and body art practice act does not apply to or restrict the activities of the following: . .. [a]ny person or licensee engaged in the practice of airbrush tanning ... . 180 ind. h.r. 1115. this legislation seeks to protect minors, but it does not include adults who are unaware of the dangers posed by spray tanning, specifically the inhalation or ingestion of dha. further, the purpose of this proposed house bill is to prevent criminal activity on the part of the spray tan applicator. compare maureen hayden, news from terre haute, indiana: bill would restrict spray-tanning for teens, cnhi statehouse bureau (jan. 12, 2012), http://tribstar.com/ indiananews/x1267391974/bill-would-restrict-spray-tanning-forteens/print (discussing a bill that would require teenagers who want to be spray-tanned in the nude to be accompanied by a parent or guardian), with state v. huffman, 847 n.e.2d 58 (ohio ct. app. 2006), affd, 872 n.e.2d 1213 (ohio 2007) (defendant convicted for violating oh. rev. code ann. § 2907.08 for recording various adult and minor female tanning salon customers during tanning bed and spray-on booth usage). 1s1 sunlight found., hb 1115, indiana last activity on jan. 9, 2012, scout, https://scout.sunlightfoundation.comlitem/statebill/ inboo002008?follow=now (last visited feb. 9, 2013); hayden, supra note 180 ("no vote was taken on the bill; it's expected to come up for a vote at a later committee hearing."). 384 vol. 11:1 a plea for consumer protection approval for minors using indoor uv tanning beds. 182 however, the bill seeks only to protect minors, and it does not include adults who are also unaware of the dangers posed by spray tanning, specifically the inhalation or ingestion of dha. nevertheless, indiana may become one of the leading states in spray tanning legislation. if enacted, this bill may be one of many that seek to adequately protect spray tan consumers from the unknown dangers associated with frequent exposure to sunless tanning solution. v. future indoor spray tanning regulations there is an absence of both federal and state supervision of commercial spray tanning establishments. 18 3 all of the recent regulations of the tanning industry have been restrictions on the use of uv tanning. 184 because the current state of indoor tanning regulation does not extend to spray tanning booths, consumers are not adequately protected or informed about the unknown risks associated with long-term human exposure to sunless tanning solutions. while salons can offer the application of a spray tan, it must be made clear that the use of a spray tan booth is not fda approved. in light of this fact, this section discusses multiple avenues for future regulation of the spray tanning industry, including more rigorous federal regulations, enhanced state regulations, and the possible adoption of a uniform age requirement for spray tan application. a. rigorous federal regulation of the in door spray tanning industry the fda should monitor, restrict, or regulate spray tan application more stringently both on a national and local 182 ind. code § 25-8-15.4-15, 16 (2013); hayden, supra note 180 (describing the proposed bill as being "much like the current state law that requires parental approval for minors using indoor-tanning booths."). 183 fu et al., supra note 11, at 710. 184 see ariz. rev. stat. ann. § 15-718 (2012); see sources cited supra note 157. 3852014 indiana health law review level. to adequately protect the american public, the u.s. federal government should enact "[ulniform guidelines . . . to address safety issues associated with sunless tanning booth use. future investigations are warranted to assess both the medical and behavioral implications of perpetuating the aesthetic appeal of the tan."185 additional licensure requirements and increased salon inspection could be useful as well.186 sun protection is key to human health, and there is evidence that spray tanning and the use of sunless tanning products do little to change sun protection patterns, as "the majority of individuals undergoing spray-on sunless tanning do not alter their sun exposure or their sunscreen use as a result of using sunless tanning."187 a recent report further supports this notion, as "10.8% of american adolescents used sunless-tanning products and . . . this practice was associated with risky uv-radiation exposure-related behaviors, including natural and artificial radiation." 188 thus, federal authorities must ensure that consumers are aware that the use of spray tanning and other sunless tanning products will not increase protection against the unwanted human health hazards associated with uv exposure. most importantly, the uniform application of a federal regulation across the nation would provide the greatest consumer protection, as salons and consumers alike would probably experience less confusion in locating and understanding the law. 185 fu et al., supra note 11, at 706. 186 id. at 711 ("although the fda advises consumers to ask for appropriate protection against [unwanted sunless tanning] exposures, at this time, mechanisms for licensing and inspecting commercial facilities with sunless tanning booths are lacking.") (internal citation omitted). 187 sheehan & lesher, supra note 2, at 1192. 188 e. tella et al., french teenagers and artificial tanning, j. of european acad. of dermatol. and venereology (2012). 386 vol. 11:1 a plea for consumer protection b. enhanced state and local health authority regulation of indoor spray tanning as no current spray tanning regulations exist at a federal or state level, consumers would benefit greatly from state action. following the trend of greater regulation of uv tanning beds, 189 spray tanning devices should be included within every state statutory scheme regulating indoor tanning facilities. as legislation alone is insufficient to restrict access to artificial uv radiation-emitting sun beds, 190 the states may need to employ other mechanisms to safeguard consumers and may need to enlist local health authorities in this endeavor. because many states have passed legislation n limiting youth access to indoor uv radiation exposure, 191 the states should also consider the potential human health hazards associated with the misting of sunless tanning solutions. accordingly, preventive state efforts are necessary to protect the american public. state legislatures should consider public policy interests, potential detrimental health outcomes from continued exposure to sunless tanning solutions, and examples of proposed or evolving legislation in other states that seek to protect the public from chemical inhalation and absorption during spray tan application. in looking to similar industries, state legislatures could compare potential sunless tanning regulation to uv tanning regulation, 192 tobacco regulation, 193 and alcohol regulation. 194 most 189 see supra section iv. b. 1. 190 makin et al., supra note 77, at 292. 191 latrice c. pichon et al., youth access to artificial uvradiation exposure. practices of 3467 us indoor tanning facilities, 145 arch. dermatol. 997, 1001 (2009). 192 see supra section iv. a, b. 193 obayan, legislation restricting tanning access, supra note 66, at 68 (discussing that "the following have been found to increase effectiveness of tobacco policy: (1) study of existing laws to measure effectiveness of the policy; (2) assessment of the legal limitations of the policy; (3) analysis of the legislative cycle to determine the most optimal time at which to propose the legislation; and (4) gathering information on past voting records of potential supporters of the legislation . . . the strategies used to draft and enforce effective tobacco policy would be 3872014 indiana health law review importantly, state authorities should endeavor to conduct studies on the potential health effects associated with continued exposure to sunless tanning solution. in order to avoid inhalation or absorption of the sunless tanning solution into any mucous membrane, state regulations should mandate that consumers wear protective eyewear and cover the lips and nostrils during spray tan application to ensure greater consumer protection.195 while additional regulations are desirable, each state must ensure effective enforcement mechanisms are in effect to incentivize salon and consumer compliance. without proper enforcement, safety precautions adopted by the states would likely be futile.196 by way of the tanning tax as well as licensure and permitting requirement, the states can acquire the necessary funds to ensure that the enacted regulations are implemented as intended. c nationwide minimum age requirements for indoor spray tanning a more extreme approach to addressing the dangers associated with spray tanning use is the option for the fda or individual states to enact nationwide minimum age requirements for spray tan application. salon employees should know of the potential dangers associated with dha and should be adequately trained to prevent customers from inhaling or ingesting the solution during spray tan application. this subsection suggests that uniform similarly beneficial when applied to policy restricting youth access to tanning beds."). 194 mayer et al., supra note 74, at 4 ("as is the case with enforcement activities regarding tobacco and alcohol control, businesses are less likely to comply with age-of-sale laws if noncompliance is not penalized.") (internal citations omitted). 195 sunless tanners guidance, supra note 24 ("consumers should request measures to protect their eyes and mucous membranes and prevent inhalation."). . 196 mayer et al., supra note 74, at 3 (discussing that in a 2008 study "data indicate that routine annual inspections, which are a prerequisite for other enforcement activities such as levying penalties for violations" are not conducted in the majority of indoor uv tanning salons.). 388 vol. 11:1 a plea for consumer protection legislative enforcement of a nationwide spray tanning age restriction would be the most effective way to protect the american youth.197 legislators could look to uv tanning legislation to pave the way for a nationwide minimum age restriction for the use of spray tanning booths as well.198 balancing the triad of parental autonomy, child interests, and state interests, many states presently regulate minors' exposure to uv tanning beds through age restrictions, parental consent, and parental presence. 199 such an approach could be beneficial in restricting minors' access to spray tan application as well. consistent with the fda's approach to regulating other carcinogens, the fda is likely to continue to allow adult users to make individual risk assessments with respect to tanning use, including both uv bed and spray tan exposure.200 nevertheless, both federal and state governments have an interest in protecting the american youth, as children are often too immature and too vulnerable to advance their own interests or exercise their own rightswhich are limitations the law has recognized. 201 because continued exposure to sunless tanning solutions 197 makin et al., supra note 77, at 291 ("in the united states, compliance with state laws restricting access [to indoor tanning facilities] for minors has been found to be less than optimal, potentially partly due to lack of enforcement.") (internal citations omitted). 198 pulley, supra note 68, at 1207-11 (discussing the possibility of a nationwide minimum age restriction or a nationwide ban on indoor uv tanning bed usage as of 2009). 199 see supra part w.b.1. 200 family smoking prevention and tobacco control act, pub. l. no. 111-31, § 2, 123 stat. 1776, 1777 (2009) ("federal and state governments have lacked the legal and regulatory authority and resources they need to address comprehensively the public health and societal problems caused by the use of tobacco products."); see knapp, supra note 10, at 38 ("fda and congress allowed saccharin to stay on the market despite concerns that it caused cancer . . . because the public was attached to its benefits.") (internal citations omitted). 201 see, e.g., prince v. massachusetts, 321 u.s. 158 (1944) (discussing how to allocate authority among parents, the child, and the state to make important decisions affecting the child and holding that parents are not free to make martyrs of their children before such time as the children have reached the age of full and legal discretion to make that choice for themselves). 3892014 indiana health law review has not been researched on humans, a nationwide age minimum on the use of spray tanning booths would be the best preventative measure to ensure that all minors within the u.s. are uniformly protected against this uninvestigated product. vi. regulatory alternatives while current regulation of the indoor tanning industry combined with the aforementioned recommendations will ensure that indoor tanning is as safe as possible, regulation alone is insufficient to safeguard consumers.202 at present, regulation of the indoor uv tanning industry is still evolving, and the use of spray tanning facilities is not regulated at all. therefore, this section considers possible non-regulatory alternatives to supplement indoor tanning regulation. this section explores some possible alternatives including: promoting consumer education, encouraging salon self-regulation, education, and appropriate advertising, and endorsing safer alternatives to achieving a tanned appearance. beyond these basic alternatives, this section suggests that changing perceptions about desirable skin tones may be the fundamental change necessary to sway societal attitudes away from artificial tanning practices. a. promoting consumer education one non-regulatory alternative to provide greater protection for indoor tanning consumers is to increase the amount of information available to consumers regarding the dangers of tanning. while public education initiatives aimed at reducing consumer exposure to uninvestigated chemicals such as spray tanning solutions may be difficult 202 see, e.g., pawlak, supra note 6, at 1010 ("other interventions could assist in decreasing youth indoor tanning, including promoting public health announcements, implementing a tanning bed use tax, restricting marketing directed toward youth, restricting the location of tanning salons, and mandating education for tanning bed users."). 390 vol. 11: 1 a plea for consumer protection at first,203 a change in social attitudes moving away from tan-seeking practices and progressing towards an increased desire for adequate assurances of health and safety is not impossible. 204 this sub-section advocates for a more comprehensive educational scheme directed towards the american public to promote consumer health education initiatives which, to dissuade detrimental tanning practices, should be employed by medical societies, 205 state and local health organizations, federal and state governments, and by media outlets through public health announcements. 206 the lack of human studies regarding continued exposure to sunless tanning products is a serious public health issue. the carcinogenic effects of human uv exposure are also alarming. preliminary research indicates that the primary chemical ingredient in spray tan solutions, dha, may cause genetic mutations to cells and other potential human harms. 207 while there is no current evidence that spray tanning causes cancer, there is not any evidence that this 203 martin et al., supra note 7, at 2140 ("despite public education initiatives aimed at preventing skin cancer, many individuals continue to tan, citing such reasons as the relationship between tanning and physical and emotional health, an active lifestyle, and physical beauty.") (internal citations omitted). 204 paul et al., supra note 14, at 930 ("in australia, ongoing public education campaigns such as sunsmart have had some success in reducing population exposure to uv light and the numbers reported to actively seek a tan.") (internal citations omitted). 205 martin et al., supra note 7, at 2145 (these societies could include the following: the american medical association, the american academy of dermatology, the american academy of pediatrics, the endocrine society, and the american society for nutrition). 206 pawlak, supra note 6, at 1010 ("although it is difficult to establish the exact role and value of mass media interventions, such as public health announcements through television, radio, billboards, and newspapers [in regards to the indoor tanning industry], on tobacco cessation, various studies showed positive results on smoking behavior for up to [eight] years after the campaign.") (citing bala m, strzeszynski l & cahill k, mass media interventions for smoking cessation in adults (review), the cochrane collaboration (2008), http://www.cmtabaquismo.com.ar/documentos/balacochrane%20sobre% 20intervenciones%20en%201os%20medios.pdf). 207 see supra section ii. a. 2014 391 indiana health law review practice is safe. 208 tanning salons offer spray tanning to consumers without fda approval of this practice. consumers have the right to know that exposure to sunless tanning solution as a misted-on spray is potentially unsafe. accordingly, proper health care initiatives and policies must be in place to protect future generations from the potential health risks associated with tanning practices. for this reason, additional research may be necessary. additional research may better facilitate the development of effective public health education initiatives by more fully understanding the long-term underpinnings of current social attitudes towards sun exposure, uv tanning bed usage, and spray tan application. 209 education is a necessary component of preventive campaigns against the use of spray-on sunless tanning products. 210 however, education alone may be an insufficient means of regulating the harmful effects of indoor tanning products. 211 208 see, e.g., philip caulfield, spray tanning could cause cancer: report, new york daily news (june 13, 2012, 1:32 pm), http://www.nydailynews.com/life-style/health/spray-tanning-cancerreport-article-1. 1094938?locallinksenabled=false ("medical experts warn that key ingredient in tanning spray could be harmful if inhaled."); spray tanning may cause cancer, too, findlaw.com (june 14, 2012), http://commonlaw.findlaw.com/2012/06/spray-tanning-maycause-cancer-too.html ("new information indicates that spray tanning may cause cancer; just when you thought it was safe."). 209 martin et al., supra note 7, at 2145 (suggesting that "[medical societies need to collaborate on a unified statement with recommendations on nutrition, vitamin d supplementation, and uv prevention" to develop effective public health education initiatives to discourage indoor uv tanning practices). 210 tella et al., supra note 188 ("given the prevalence of indoor uv tanning in france, especially by teenagers, despite its being forbidden by law, and its known risks, public health authorities must enforce compliance with the legislation and focus its prevention campaigns on at-risk teenagers."); katie brooks et al., use of artificial tanning products among young adults, 56 j. am. acad. dermatol. 1060, 1065 (2006) ("[tlhe manufacturers of artificial tanning products have a responsibility to inform consumers of the content of the product, and the risks involved with product use."). 211 makin et al., supra note 77, at 291 ("[glovernment regulation of the indoor tanning industry is indeed a better whole-population approach to this health issue than voluntary standards and/or industry or consumer education."). 392 vol. 11:1 a plea for consumer protection additional non-regulatory alternatives should also be considered. b. encouraging self-regulation, operator education, and appropriate advertising by salons another non-regulatory alternative to increase consumer protection could be implemented by the industry itself. while there is evidence of an industry-backed comprehensive national program to reinforce the fda's safety recommendations during spray tan application, will this result in improved compliance everywhere? 212 this sub-section seeks to encourage self-regulation amongst tanning salons, to promote training for indoor tanning bed and spray tan booth operators, and to support appropriate advertising by salons. these practices could be promoted among indoor tanning facilities because such initiatives may increase consumer confidence in the industry.213 while some states already mandate training for indoor uv tanning bed operators, 214 no such regulations are in 212 fu et al., supra note 11, at 710 ("[tlhe national tanning training institute has begun to advertise a sunless tanning certification course similar to courses in uv tanning, popular in states that require the training of personnel for salon licensing."). 213 nat'l tanning training inst., online training, tanningtraining.com, http://www.tanningtraining.com/ (last visited july 7, 2013) ("professional expertise granted through ntti's online programs has helped to increase tanning consumer confidence with the most up-to-date information available in the industry."). 214 see ariz. admin. code § r12-1-1414(a)(2) (2013) (tanning equipment operators); ark. code ann. § 20-27-2201(2)(a) (2013) (effective july 31, 2009) (definitions); cal. bus. and prof. code § 22706(b)(3) (2013) (operating regulations, customer acknowledgement of warnings; use of facilities by minors); colo. rev. stat. § 25-5-1007 (2013) (owner responsibilities); conn. gen. stat. § 19a-232 (2013) (tanning facilities); 16 del. code ann. tit. 16, § 3002d(4) (2013) (effective aug. 13, 2009) (definitions); fla. stat. § 381.89(7) (2013) (regulation of tanning facilities); ga. code ann. § 31-38-7 (2013) (protective goggles); 210 ill. comp. stat. ann. 145/25 (west 2012) (operating requirements); ind. code § 25-8-15.4-14 (2013) (duties of operator); iowa code § 136d.7 (2013) (duties of department); kan. stat. ann. § 65-1924 (2013) (presence of trained operator required); ky. rev. stat. ann. § 217.924 (west 2012) (requirements for tanning 2014 393 indiana health law review place for the operation of spray tanning booths. the promotion of self-regulation will lead to operators being properly trained for both uv and spray tanning devices. 215 while training requirements vary amongst salons and by state, important elements to any training program include education about the proper use of salon equipment and knowledge of the risks associated with such use. educated salon operators will be better equipped to instruct consumers on how to adequately protect themselves from inhalation and prohibited absorption during spray tan application. appropriate advertising schemes by the tanning industry and individual salons will more adequately protect consumers through product awareness as well. 216 facilities); la. rev. stat. ann. § 40:2713 (2013) (operational requirements); 10-144 dept. of human services ch. 223 12a(3)(f) (2013) (effective mar. 1, 1991) (rules relating to tanning facilities); mass. gen. laws ch. 111, § 210 (2013) (presence of operators); mich. comp. laws § 333.13405(1) (2013) (effective dec. 23, 2008) (use of tanning devices); minn. stat. § 325h.03 (2013) (standards for tanning equipment); n.h. rev. stat. ann. § 313-a:30 (2013) (operational requirements); n.j. stat. ann. § 26:2d-83 (2013) (effective june 29, 2012) (minimum safety standards; establishment by regulation; signage); n.c. gen. stat. § 104e-9.1(a)(1) (2013) (restrictions on use and operation of tanning equipment); n.d. cent. code § 23-39-05(1)(a) (2013) (effective aug. 1, 2007) (duties); ohio rev. code ann. § 4713.48 (2013) (regulation of tanning facilities); or. admin. r. 333-119-0090(2) (2013) (protection of consumers); r.i. gen. laws § 23-68-4(6) (2013) (effective jan. 1, 2013) (safety standards established); tenn. code ann. § 68-117-104(a)(1) (2013) (duties); tex. health & safety code ann. § 145.008 (west 2010) (operational requirements); utah code ann. § 2615-13 (west 2012) (regulation of tanning facilities); vt. stat. ann. tit. 18, § 1513(a)(1) (2013) (effective july 1, 2012) (tanning facilities); va. code ann. §59.1-310.5 (2013) (effective july 1, 2007) (operational requirements); wis. stat. § 255.08(9)(b) (2013) (tanning facilities). 215 the national tanning training institute (ntti) offers five online courses: a basic tanning certification, a salon operations and procedures course, a lotions and skincare course, an introduction to sunless tanning, and a sunless airbrush technician course. nat'l tanning training inst., supra note 213. 216 martin et al., supra note 7, at 2145 ("advertisements continue to promote tanning, even in high school newspapers, despite substantial scientific evidence that tanning-bed use correlates with skin cancer." (footnotes omitted)). 394 vol. 11:1 a plea for consumer protection c. endorsing safer alternatives to achieving a tanned appearance spray tanning devices were introduced to the market as a safer alternative to indoor uv tanning practices. however, spray tan exposure "has not been well studied in the context of skin cancer prevention."217 spray tans have not been scientifically investigated and are therefore not proven to be safe. similarly, exposure to indoor uv tanning beds is known to be carcinogenic. 2 18 for these reasons, the tanning industry could promote sunless tanning lotions as a safer alternative to indoor uv tanning bed use or spray tan application. the fda endorses the use of sunless tanning products sold in retail stores such as creams and lotions. 219 although individual tanning salons may see this method as detrimental to the industry, product manufacturers may endorse the promotion of sunless tanning lotions. under the authority of the fpla, the fda "requires ingredient declarations on cosmetics sold on a retail basis to consumers."220 by purchasing sunless tanning lotions and creams from a retail store, consumers have access to full knowledge of the ingredients contained in these products, and can avoid potentially harmful ingredients. however, consumers do not have this courtesy when utilizing commercial spray tanning facilities, as the "fpla does not apply to products used exclusively by professionals, such as those used in spray tanning booths."221 until research is conducted on the effects of spray tan absorption and inhalation on the human body, consumers could benefit greatly from the promotion of safer alternatives to achieving a tanned appearance. 217 sherry l. patogo et al., the sunless study. a beach randomized trial of a skin cancer prevention intervention promoting sunless tanning, 146 arch. dermatol. 979, 982 (2010). 218 brod, supra note 11. 219 sunless tanners guidance, supra note 24 ("dha is approved for external application to the human body, which is the way [creams and lotions] are intended to be used."). 220 id. 221 id. 2014 395 indiana health law review d. changing perceptions about desirable skin colors despite additional regulation, education, and the availability of healthier alternatives, many americans continue to frequent tanning facilities. 222 encouraging consumers to stop tanning, however, will "'require a fundamental change in the societal belief that tans are attractive and healthy.' 223 while tanning allegedly makes individuals look darker, healthier, and thinner, "unknown are the specific dimensions of how body-tanning functions in achieving attractiveness among adolescents." 2 24 likewise, "further investigations are needed to evaluate the behavioral implications of continuing to perpetuate the aesthetic appeal of the tan."225 a fundamental change in the societal perceptions about desirable skin colors will be a slow transition, but it is a movement that may benefit the u.s. public as a whole. in the meantime, the aforementioned regulatory and nonregulatory alternatives should be encouraged and implemented by federal and state governments, local and national health authorities, and organizations generally concerned with the health of the u.s. public. indoor 222 am. acad. of dermatology, indoor tanning, aad.org, http://www.aad.org/media-resources/stats-and-facts/prevention-andcare/indoor-tanning (last visited july 7, 2013) ("on an average day in the united states, more than [one] million people tan in tanning salons. . . nearly [twenty-eight] million people tan indoors in the united states annually. of these, 2.3 million are teens.") (internal citations omitted); compare cokkinides, supra note 172, at 987 ("the prevalence of selfreported use of sunless tanning products in the past year among us adolescents was 10.8%."), with veronica a. russo et al., patterns of use of sunless tanning product alternatives to indoor tanning among female college students, 148 arch. dermatol. 855 (2012) (a 2012 study showed that eighty-seven percent of female college student participants used sunless tanning products). 223 pulley, supra note 68, at 1223 (quoting j. matthew knight et al., awareness of the risks of tanning lamps does not influence behavior among college students, 138 arch. dermatol. 1311 (2002)). 224 jeong-ju yoo & hye-young kim, adolescents' body-tanning behaviours:influence of gender, body mass index, sociocultural attitudes towards appearance and body satisfaction, 36 int'l j. of consumer studies 360, 365 (2012). 225 fu et al., supra note 11, at 712. 396 vol. 11:1 a plea for consumer protection tanning practices should be as safe as possible, and regulatory schemes as well as educational initiatives may help to achieve this purpose. vii. conclusion for the past three decades, federal and state governments as well as health advocates have been working towards regulating the indoor tanning industry, a desirable service with detrimental health effects. in response to the carcinogenic properties of uv tanning bed exposure, the rapidly growing sunless segment of the indoor tanning industry was promoted as a safer alternative to achieving the desired dark appearance. because of the uninvestigated long-term health effects of repeated exposure to spray tanning solutions with the active ingredient of dha, the spray tanning industry should be more heavily regulated on both a federal and state level. consumers should be adequately informed of the limited scientific knowledge about the potential threats that spray tanning solutions may pose to the human body. without such awareness, consumers will be unable to make informed decisions about spray tanning practices. the fda and other health organizations should undertake investigations regarding the frequent exposure to and absorption of all sunless tanning products, with a specific inquiry into the safety of spray tans applied with misters. the collection of such scientific data will allow health authorities to identify risk factors associated with these products, which will in turn enable the federal and state governments to more adequately protect consumers. before any endorsements are made of the sunless tanning booth, further investigations are necessary to evaluate the potential human health hazards associated with the 2014 397 indiana health law review continued use of dha in spray tan application. 226 tanned skin is a sign of injury and "healthy" tans do not exist.227 226 brooks et al., supra note 210, at 1065 ("while safe alternatives to prolonged sun exposure or use of tanning beds are desirable, the potential risks of endorsing artificial tanning products must be thoroughly considered."). 227 sun safety, am. skin ass'n, http://www.americanskin.org/ resource/safety.php (last visited july 6, 2013). vol. 11:1398 indiana health law review volume 10 2013 issue 2 table of contents preface ................. ........................... ........... i aals symposium articles: imagining the next quarter century of health care law gaia bernstein unintended consequences: prohibitions on gamete donor anonymity and the fragile practice of surrogacy................... ............ 291 kristin madison donabedian's legacy: the future of health care quality law and policy.................... .............................. ..... 325 barbara j. evans why the common rule is hard to amend ........................ 365 peter j. hammer health evolution: (quality = learning) + (ethics = justice) .......... .... 415 efthimios parasidis health outcomes metrics and the role of financial derivative instruments in the health care industry ............................ 447 articles crystal t. williams where's the beef? an examination of the "pink slime" controversy and the implications of the real beef act on state truth-in-menu laws............... jennifer s. bard putting patients first: how the fda could use its existing powers to reduce post-market adverse events.. ......................... 473 495 notes kyle r. wood ncaa student-athlete health care: antitrust concerns regarding the insurance coverage certification requirement............... ..... 561 frandy st. louis the decline of mandatory physical education in grade schools resulted in the current childhood obesity crisis and consequently an unsustainable rise in health care spending...................... 629 julia hudson have your cake and eat it, too: how states could leverage data on quality to promote health care transparency & patient privacy within consumer-driven health care initiatives ..................... 663 jacob o'brien a review and evaluation of indiana's inspect system and governing legislation: maximizing potential impact on public health .. ............ 701 preface upon reflection, the indiana health law review is quite a story. unlike so many products of corporate america and academic institutions, it was not a concept hatched as part of a long (or short) term strategic plan. it was, simply, a wild hair. but, ten years and ten volumes later, perspective tells us that it was fueled by tremendous will, supported by common sense, and the timing was right. the origins of the indiana health law review, as it is being told for the first time, is one of fate.. .and a little luck. in 2000 and 2001, when we started our law school careers, the indiana university robert h. mckinney school of law had consistently been recognized as one of the top health law programs in the country. as students interested in health law, we were acutely aware of this. the program's reputation was no accident. after all, the center for law and health (as it was called then), had been established in 1987 to expand the curriculum and teaching of health law and provide opportunities for student participation in center-sponsored research, educational programs, and health law field placements. this strategy was laid by the center's co-directors, eleanor kinney and david orentlicher. professor kinney, the founding director, had a distinguished academic background, had worked for the u.s. department of health and human services and the american hospital association, and was a widely published author and respected lecturer. professor orentlicher was a physician, an adjunct professor of medicine at the iu school of medicine, and in 2002 became a six-year member of the indiana house of representatives. fortunately for us, they were committed to sharing their intellect and talents with the law school and its students. in the summer of 2001, the law school moved into a new building providing the center for law and health with a new and improved space. this sparked new enthusiasm among faculty and students. the health law course offerings were expanding and the school was more frequently hosting distinguished health law speakers and i cle programs, further energizing the members of the student interest group health law society. and the school's downtown indianapolis location placed it near several major pharmaceutical firms, many of the state's leading medical centers, health insurers, health law firms, and the health agencies of state government. among other things, this helped support the development of more internships, placements, a professional network of alumnus and a robust adjunct faculty. it seemed to be a perfect recipe the possibilities were endless. and then came the light bulb. nearly all of the other ranked health law programs had a journal. in many respects, the journal was the public face of the program. a ubiquitous reminder of the program, the faculty and students and even the university. why didn't our school have one? academics, practitioners, students and even the university would benefit from it. professor kinney will confess that she originally thought the idea was lofty...actually, crazy. but, she eventually came around and convinced the dean it was a good idea. a few of us were in the initial startup group that set out to draft a business plan. we knew nothing about business plans, but fortunately we didn't have to start from scratch. the school already had two very successful journals the indiana law review and the indiana international and comparative law review. throughout the process, they graciously shared their time and resources to assist us. to this day, we remain indebted for their startup support. we expanded our small startup to a core group of students with critical professional, academic and law review experience to serve as the proposed first editorial board. with the business plan complete and a leadership team complete, we presented it (and ourselves) to the full faculty....a presentation that nearly didn't happen. it was the end of the 2003 spring semester and our hopeful editorial board would be starting our final year of law school in the fall. we were asked to postpone our faculty presentation until the fall due to an already busy agenda. postponing would have set us back an entire school year and our core group would graduate before we could get the ii journal off the ground. any necessary momentum would have been lost. instead, we successfully advocated through professor kinney to stay on agenda. that was a defining moment, along with the dean delivering the good news. and the indiana health law review was born at least conceptually. as luck would have it, the center for law and health had already outgrown its space and that summer we were permitted to join them in their newly dedicated william s. and christine s. hall center for law and health. but, we didn't have any money and we nearly overstayed our welcome in the first week when we furnished the office with refurbished desks and not-sogently used chairs. professor kinney was so mortified that she bought us new chairs! the next twelve months were a blur. the other two law reviews were kind enough to include us in their joint writing competition so we could populate the journal with student members. we are indebted to those 18 students who took the leap of faith to join us that year to be volume 1. they were and are the lifeblood. our other debt of gratitude goes to the talented authors who responded to our callout and were willing to send their prized academic work to a startup journal. without content, there is no book to publish. a startup journal could have easily failed in its early years. but it didn't. volume 2 picked up where we left off, and so on. the indiana health law review has thrived in these first ten years, just as we would have hoped. it has expanded to multiple issues per year, continued to publish valuable and relevant content, hosted symposia, and in 2011 the highly-regarded professor nicolas terry joined the faculty for the retiring eleanor kinney. the future continues to be bright. our volume 1 journey was guided at every step by the sage and steady advice of our chief faculty advisor, professor larrie wilkins. his guidance and moral support were crucial to our success. as we celebrated volume 1, professor wilkins shared with us his thoughts on our first year and the future. we borrow his eloquence and share it iii with the past, current, and future members of the indiana health law review: so, to you all, [we] ask that you raise a glass. [we] offer a toast to your great success. and while you have those glasses raised, [we] ask that you look your colleagues in the eye and pledge yourself to continued and palpable support of those who will come after you as they strive to meet your standards and carry on the traditions that you have established for them. congratulations to all past, current and future members of the indiana health law review. [we] salute you! sincerely, volume 1 editorial board indiana health law review brian c. betner gina m. brown leeanne r. coons shelley s. fraser kelly j. (green) greene heidi k. hughes julie d. reed iv aals symposium articles: imagining the next quarter century of health care law 12_10indhealthlrev[xv](2012-2013) 13_10indhealthlrevi(2012-2013) beyond the emergency room doors: rejecting patient admittance as satisfaction of hospital obligations under emtala beyond the emergency room doors: rejecting patient admittance as satisfaction of hospital obligations under emtala charlotte fillenwarth* i. introduction .................................. 792 ii. the history of preventing patient dumping ........ 793 a. historical responses to patient dumping............794 iii. the emergency medical treatment and active labor act (emtala) .................... ..... 797 a. emtala's medical screening requirement.........799 b. emtala's stabilization requirement.... .... 801 c. enforcement of emtala......................803 iv. emergence of the issue: the circuit split............805 a. the sixth circuit considers the issue: thornton v. southwest detroit hospital............ ...... 805 b. the fourth circuit weighs in: bryan v. rectors and visitors of university of virginia ...... ....... 807 c. the supreme court's most recent emtala ruling: roberts v. galen of virginia, inc....... ......... 809 d. the ninth circuit creates a new standard: bryant v. adventist health system/west .................. 810 e. the cms regulations adopt the ninth circuit's approach .............................. 811 f the sixth circuit responds: moses v. providence hospital and medical centers, inc. ............ 814 v. discussion ............................. 817 a. rejecting the cms regulations ............. 817 b. plain meaning ............................... 819 c legislative intent ....................... 822 d. policy concerns. ......................... 824 1. the sixth circuit's approach does not supplant state medical malpractice laws ..... ..... 824 * j.d. candidate, 2014, indiana university robert h. mckinney school of law, indianapolis, indiana; b.a., 2011, purdue university, west lafayette, indiana. indiana health law review 2. the ninth circuit's approach is inconsistent with the supreme court's holding in roberts v. galen...................... ........... 827 vi. conclusion ................................. ...... 829 i. introduction currently, federal circuit courts are split over the proper interpretation of important obligations that the emergency medical treatment and active labor act (emtala) places on participating hospitals. under emtala, hospitals must provide a medical screening to all patients who come to the hospital's emergency department. if a physician identifies an emergency medical condition, the hospital must provide the patient with stabilizing treatment prior to transfer or discharge. in the last decade, a common fact pattern has repeatedly emerged that emtala does not explicitly contemplate. this set of facts begins with a sick or injured individual coming to a hospital emergency room for treatment. after performing the proper medical screening, a physician discovers an emergency medical condition and admits the patient to the hospital for further treatment or testing. in most cases, the patient will spend between a few days and a few weeks at the hospital recovering before the hospital discharges the patient. following the discharge, the patient's condition worsens or, in some cases, the patient dies. the patient or a representative files suit alleging that the patient's condition worsened because the hospital discharged the patient at a point when the individual was not medically stable. in these situations, courts are divided on the viability of patients bringing emtala claims in spite of hospital admittance. the fourth and ninth circuits represent the view that the stabilization requirement may be fulfilled by admitting a patient to the hospital. the sixth circuit represents the view that stabilization is only fulfilled when a patient's medical condition is not likely to deteriorate upon transfer 792 vol. 11:2 2014 rejecting patient admittance under emtala or discharge. under this view, a patient's admittance to an inpatient care unit is irrelevant in determining if the stabilization duty has been fulfilled. the sixth circuit's interpretation should be followed because it represents the plain meaning of the statute, honors the legislative intent, and provides consistency with the united states supreme court's holding in roberts v. galen of virginia, inc. this note begins by examining the history surrounding patient dumping and the early attempts to correct the widespread problem among the nation's hospitals. this will include a consideration of how common law doctrines, state legislation, and the hill-burton act failed to rectify the problem. the second part of this note will provide an overview of emtala's background and content. this will include a comprehensive examination of the stabilization provision and accompanying definitions. next, this note will describe the multiple interpretations of emtala's stabilization requirement articulated in federal circuit court cases. cases from the sixth circuit, fourth circuit, and ninth circuit will be introduced to illustrate the conflict among the various interpretations. the last part of this note will present an analysis demonstrating the most appropriate approach to emtala's stabilization requirement. the note concludes that the sixth circuit's interpretation is the proper approach to apply to patient treatment under emtala. ii. the history of preventing patient dumping patient dumping is the "denial of or limitation in the provision of medical services to a patient for economic reasons and the referral of that patient elsewhere."' this practice occurs when an uninsured patient comes to a hospital emergency department seeking treatment. once a hospital representative determines the patient is unable to pay for the required medical services, the hospital can either absorb the costs or "dump" the patient, either by referring the patient to another facility or simply turning 1 david a. ansell & robert l. schiff, patient dumping: status, implcations, and poicyrecommendations, 257 jama 1500 (1987). 793 indiana health law review the patient away. because providing free medical services is an expensive and inefficient business model, the hospital is financially incentivized to dump the patient. this practice leads to serious societal harms for both patients and hospitals. 2 patients referred to alternative hospitals and clinics may experience poor medical outcomes, and city hospitals receiving these indigent patients bear a disproportionate share of the absorbed costs of providing free health care. 3 a. historical responses to patient dumping under common law, it is well settled that hospital emergency departments are not obligated to accept patients for treatment. 4 even so, some courts have carved out narrow exceptions based on the common law theories of reliance and abandonment. 5 according to the reliance theory, "liability on the part of a hospital may be predicated on the refusal of service to a patient in the case of an unmistakable emergency, if the patient has relied upon a well-established custom of the hospital to render aid in such a case." 6 this requires proof that an unmistakable emergency existed, there was a well-established custom of providing care in such circumstances, and that the patient relied on that custom.7 this is a difficult standard to prove because the elements are vague and it requires proving the patient's mental state. the abandonment theory provides that a hospital may be held liable for the failure to treat a patient in the emergency department if it is found that the hospital began to render care and then abandoned the patient by discharge or transfer.8 because it requires a 2 id. at 1500-01. 3 id. 4 see, e.g., birmingham baptist hosp. v. crews, 229 ala. 398, 399 (1934); brooks v. md. gen. hosp., inc., 996 f.2d 708, 710 (4th cir. 1993). 5 see, e.g., wilmington gen. hosp., v. manlove, 54 del. 15, 25 (1961); stanturf v. sipes, 447 s.w.2d 558, 561-62 (mo. 1969). 6 manlove, 54 del. at 25. 7 id. at 22-24. 8 see, e.g., le juene rd. hosp., inc. v. watson, 171 so. 2d 202, 203 (fla. dist. ct. app. 1965). 794 vol. 11:2 2014 rejecting patient admittance under emtala finding that the hospital began to render care, this theory is limited to situations where a patient received some form of treatment before being transferred or turned away. these common law exceptions are narrow and provide only limited protection for uninsured patients in need of emergency services. another response to patient dumping is state-enacted legislation. states following this approach have addressed the issue of patient dumping by enacting legislation aimed specifically at providing emergency medical care to indigent patients. 9 this response has proved to be largely inadequate. first, as there is no requirement to pass this type of protective legislation, only about half of all states have these statutes in place.10 second, most of the enacted statutes have been unsuccessful due to unclear definitions of emergencies and limited enforcement." enacted in 1946, congress first attempted to address patient dumping at the federal level with the hill-burton act. 12 the statute provided federal funds for the construction and modernization of hospitals, the promotion of medical research, and the development of new facilities for medical treatment, diagnostics, and rehabilitation.13 in exchange for these funds, the statute required hospitals to first, be "made available to all persons residing in the territorial area of the applicant" and second, to provide "a reasonable volume of services to persons unable to pay."' 4 an exception allowed hospitals to limit the provision of uncompensated services in accordance with financially feasibility. 15 to satisfy the uncompensated services requirement, the department of health and human services (formerly the department of health, education 9 karen i. treiger, preventing patient dumping.' sharpening the cobra's fangs, 61 n.y.u. l. rev. 1186, 1201(1986). 10 karen rothenberg, who cares?: the evolution of the legal duty to provide emergency care, 26 hous. l. rev. 21, 56 (1989). 11 id. at 54. 12 hospital survey and construction act, 42 u.s.c. §§ 291-291m (west 2014). 13 id. § 291. 14 id. § 291c(e). 15 id. 795 indiana health law review and welfare) issued regulations specifying that the hospital must simply provide a reasonable amount of uncompensated services annually to indigent patients. 16 the regulations required hospitals to post notice of the availability of uncompensated services so that patients would be aware of such an option. 17 to satisfy the community service requirement, the hospital could not deny emergency medical services to any person living in the hospital's service area "on the ground that the person is unable to pay for those services." 8 the hill-burton act proved unsuccessful because it failed to adequately provide emergency medical services for indigent patients.' 9 first, by 1986, just over half of all states participated in the hill-burton program to receive federal funds in exchange for an expansion of services to the indigent. 20 those states choosing not to participate were not bound by the statute's mandate. second, the ambiguous language of the hill-burton act failed to precisely define the two separate obligations that the statute imposed on participating hospitals. 21 while the statute required hospitals to perform general community services as well as uncompensated services for indigent patients, most hospitals ignored the first requirement until the early 1970s when a court ruled that the hill-burton act mandated general community service.22 next, neither the statute nor the regulations required states to maintain agencies to monitor hospital compliance, and the department of health 18 42 c.f.r. § 124.503 (2014). 17 id. § 124.504. 18 id. § 124.603(b)(2). 19 see generally michael a. dowell, hill-burton: the unfulflled promise, 12 j. health pol. pol'y & l. 153 (1987), available at http://jhppl.dukejournals.org/content/12/1/153.full.pdf. 20 id. at 154. 21 see, e.g., metro. med. ctr. & extended care facility v. harris, 693 f.2d 775 (8th cir. 1982) (considering the plain language of the statute, congressional reports and hearings, and court decisions to determine the precise obligations that hill-burton conferred on participating hospitals). 22 see cook v. ochsner found. hosp., 61 f.r.d. 354, 361 (e.d. la. 1972) (finding that the hill-burton act mandated community service obligations apart from the uncompensated services provided to indigent patients). 796 vol. 11:2 2014 rejecting patient admittance under emtala and human services was ineffective in its enforcement of the hill-burton act. 23 due to these deficiencies, the primary method of enforcing the required services to the community was individual complaints of noncompliance. 24 last, because the statute did not allow for punitive damages, hospitals had little incentive to treat the uninsured. 25 when hospitals were found in violation of the statute, courts imposed fines and ordered hospitals to comply with the requirements of the hill-burton act. 26 for these reasons, hill-burton failed to remedy the problem of patient dumping in the united states. iii. the emergency medical treatment and actwe labor act (emtala) the problem of patient dumping continued to worsen as the costs of health care increased throughout the second half of the twentieth century.27 cutbacks in government healthcare spending in the early 1980s compounded the problem by crippling the medicare and medicaid programs. 28 by the mid-1980s it was reported that, in the united states, an estimated 200,000 people were either refused medical treatment or transferred to another hospital each year due to the inability to pay.29 in a wellknown study conducted in chicago, physicians analyzed 467 patients that had been transferred from other hospitals in 23 s. rep. no. 93-1285, at 7898 (1974); dowell, supra note 19, at 162 (explaining that the enforcement mechanism "requires [the department of health and human services] to periodically investigate and ascertain the extent of facility compliance," and "to collect and review compliance data," but the "information provided in the reports is not detailed enough to document compliance adequately" and facilities fraudulently misrepresent data). 24 dowell, supra note 19, at 162. 25 see generalyrothenberg, supra note 10, at 58. 26 id at 58-59. 27 ansell & schiff, supra note 1, at 1500. 28 id 29 131 cong. rec. e5520-02 (daily ed. dec. 10, 1985) (statement of rep. fortney h. (pete) stark). 797 indiana health law review the area to cook county hospital, a major public hospital.30 of the transferred patients, eighty-nine percent were black or hispanic and eighty-seven percent lacked insurance.31 twenty-two percent of the patients that cook county hospital received required admittance to the intensive care unit, and twenty-four percent were in a clinically unstable condition upon arrival. 32 the study concluded that hospitals transferred patients depending primarily on the patient's ability to pay, even when emergency medical conditions persisted. 33 by 1985, because the hill-burton act was proving to be ineffective and only twenty-two states had implemented local anti-dumping statutes, the nation was calling for a new federal initiative to address this growing problem.34 in 1986, congress passed the emergency medical treatment and active labor act 35 (emtala) as a part of the comprehensive consolidated omnibus budget reconciliation act 3 6 (cobra) to offer an effective solution to the problem plaguing communities everywhere. the statute requires hospitals to provide medical screening examinations and stabilizing treatment to all individuals who come to a participating hospital's emergency department. 37 reflecting the legislature's concern for indigent patients, the statute specifically prohibits hospitals and physicians from delaying the required medical screening examination and any stabilizing treatment or transferring "in order to inquire about the individual's method of payment or insurance status."3 8 30 robert l. schiff et al., tansfers to a pubihc hospital. a prospective study of467patients., 314 new eng. j. med. 552, 552-57 (1986). 31 id. at 555. 32 id. at 553-54. 33 id. at 556. 34 h.r. rep. no. 99-241, pt. 3, at 5 (1985), reprinted in 1986 u.s.c.c.a.n. 726, 727. 35 42 u.s.c. § 1395dd (2014). 36 medicare and medicaid budget reconciliation amendments of 1985, pub. l. no. 99-272, § 9121(b), 100 stat. 164. 37 42 u.s.c. § 1395dd. 38 id. § 1395dd(h). 798 vol. 11:2 2014 rejecting patient admittance under emtala a. emtala 's medical screening requirement the responsibilities mandated by emtala apply to all hospitals that maintain an emergency department 39 and maintain provider agreements with medicare. 40 under emtala's medical screening requirement, the hospital must provide an appropriate medical screening examination, "within the capability of the hospital's emergency department", to any individual who comes to the emergency department in order to determine if an emergency medical condition exists.41 an individual has "come to the emergency department" if the individual presents himself or herself at the emergency department, arrives outside the emergency department on hospital property, or arrives at the emergency department by ambulance or helicopter. 42 some courts have also held that a patient being treated in an ambulance en route to the hospital has also "come to the emergency department" for the purposes of the statute. 43 an "appropriate medical 39 id. § 1395dd(a) (specifying "[in the case of a hospital that has an emergency department..."). 40 id. § 1395dd(e)(2). 41 id. § 1395dd(a). 42 special responsibilities of medicare hospitals in emergency cases, 42 c.f.r. § 489.24(b) (2014). 43 see morales v. sociedad espanola de auxilio mutuo y beneficencia, 524 f.3d 54 (1st cir. 2008). the issue arose when an ambulance was called for an individual experiencing severe abdominal pain and vomiting in conjuncture with her recent nonviable ectopic pregnancy. id. at 55. once loaded into the ambulance, the paramedic called a nearby hospital to notify the emergency department of the patient's condition and need for treatment. id. a physician at the receiving hospital spoke to the paramedic and inquired as to whether the patient had medical insurance. id. at 56. after learning the patient was uninsured, the physician promptly ended the call, and the paramedic understood this to mean that the hospital would not receive the patient. the patient was taken to a different hospital for treatment. id. in the case, the hospital argued it was not liable to the patient under emtala because the patient had not physically "come to the emergency department," but rather, the patient was in an ambulance en route to the emergency department. id. at 56. the court rejected this line of reasoning as contrary to emtala's intent, and it found that a patient en route to the emergency department has "come to the emergency department" for the 799 indiana health law review screening" requires the hospital to "apply uniform screening procedures to all individuals coming to the emergency room of the hospital requesting treatment."44 therefore, as long as a patient receives the same medical screening that any other patient would receive in the emergency department, a hospital will not be in violation of emtala for failure to diagnose. 4 courts universally agree that claims of this nature should be brought under state medical malpractice theories and not emtala. 46 an "emergency medical condition" is defined in the statute as "a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in..." placing the patient's health in "serious jeopardy," "serious impairment to bodily functions," or "serious dysfunction of any bodily organ or part."4 7 in the case of a pregnant woman experiencing contractions, an "emergency medical condition" is present if "there is inadequate time to effect a safe transfer to another hospital before delivery" or transfer would threaten the health of the woman or her unborn child.48 purposes of the statute. id. at 60. the court noted that under the hospital's interpretation, "an uninsured or financially strapped person could be bounced around like a ping-pong ball in search of a willing provider. that result would be antithetic to the core policy on which emtala is based." id. at 61. 44 in re baby k, 16 f.3d 590, 595 (4th cir. 1994) (explaining "[a] hospital fulfills this duty if it utilizes identical screening procedures for all patients complaining of the same condition or exhibiting the same symptoms."); see also baber v. hosp. corp. of am., 977 f.2d 872, 880 (4th cir. 1992). 45 see, e.g., jones v. wake cnty. hosp. sys., inc., 786 f. supp. 538, 544 (e.d.n.c. 1991) (stating that the medical screening requirement is "not designed to redress an incorrect diagnosis by a hospital; instead, it is merely an entitlement to receive the same treatment that is accorded to others similarly situated."). 46 see baker v. adventist health, inc., 260 f.3d 987, 993 (9th cir. 2001); battle v. meml hosp. at gulfport, 228 f.3d 544, 557 (5th cir. 2000); baber, 977 f.2d at 880; cleland v. bronson methodist hosp., 917 f.2d 266, 270 (6th cir. 1990). 47 42 u.s.c. § 1395dd(e)(1)(a) (2014). 48 id. § 1395dd(e)(1)(b). 800 vol. 11:2 2014 rejecting patient admittance under emtala b. emtala's stabilization requirement because the emergency medical screening requirement is treated as a threshold obligation, the stabilization requirement only attaches if an emergency medical condition is identified. 49 if a patient is found to have an emergency medical condition, the hospital must provide "such further medical examination and such treatment as may be required to stabilize the medical condition"50 or "transfer of the individual to another medical facility."5 ' thus, the statute is structured such that, if the physician does not identify an emergency medical condition during the medical screening, the hospital has fulfilled its obligation under emtala and has no further duty to stabilize, so long as the medical screening was appropriate. 52 this is true 4 see eberhardt v. city of los angeles, 62 f.3d 1253, 1259 (9th cir. 1995); baber, 977 f.2d at 880; gatewood v. wash. healthcare corp., 933 f.2d 1037, 1041 (d.c. cir. 1991); cleland, 917 f.2d at 271. 50 42 u.s.c. § 1395dd(b)(1)(a). 51 id. § 1395dd(b)(1)(b). 52 eberhardt, 62 f.3d at 1259. the issue arose when a patient was presented in the emergency department with an unhealthy blood pressure, pulse, and respiration caused by snorting cocaine and then smoking a dangerously high dose of heroine. id. at 1254. after administering narcan to reduce the effects of the opioids, a physician performed a medical examination and found the patient's vitals to be within normal parameters. id. the physician diagnosed the patient as having suffered a heroine overdose and discharged him with instructions to seek long-term methadone treatment at a nearby facility. id. at 1255. a day later, police found the patient breaking windows at a private residence and armed with a machete. the patient charged the police officers who returned gunfire, hitting the patient. a witness reportedly heard the patient shout "kill me" and "put me out of my misery." id. the patient was pronounced dead at the hospital, and he was discovered to have only a small amount of alcohol in his system but no drugs of any kind. id the patient's family brought a claim under emtaia asserting that the hospital discharged the patient with an unstable mental condition when its physicians failed to detect his suicidal tendency. id. the court disagreed finding that an appropriate medical screening examination had been performed according to emtala's requirements. id. at 1257. the statute requires a screening "to identify acute and severe symptoms that alert the physician of the need for immediate medical attention to prevent serious bodily injury." id. the statute does not require physicians to detect "conditions that are not manifested by acute and severe symptoms, nor 801 indiana health law review even if an emergency medical condition did exist but was unidentified, because hospital physicians are held to an objective standard under emtala's emergency medical screening requirement. 53 to the contrary, for a violation of the stabilization requirement to occur, a physician must have actual knowledge of the emergency medical condition and the hospital must have failed to stabilize or transfer the patient.54 requiring a physician to have "actual knowledge" of the emergency medical condition before a violation can occur reflects the overall purpose of the statute. the statute was enacted to ensure that hospitals do not refuse necessary medical care to indigent patients in emergency situations, not to create a national standard of medical care.55 the statute defines "to stabilize" as "to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability that no material deterioration is likely to result from or occur during the transfer of the individual." 56 a hospital is deemed to have fulfilled this obligation if a patient refuses to consent to the necessary treatment for the medical condition.5 7 likewise, if a patient refuses to consent to a beneficial transfer in accordance with the statute, the hospital is deemed to have fulfilled the stabilization requirement. 58 when a patient refuses treatment or transfer ordinarily required by emtala, the hospital should take all reasonable steps to secure the patient's informed consent to the refusal in writing.59 those that do not require immediate medical attention to prevent serious bodily injury." id. here, the patient's acute symptoms were those resulting from a drug overdose. id. because those symptoms were treated and stabilized, the hospital fulfilled its emtala obligations, notwithstanding its failure to detect the patient's suicidal disposition. id. 53 id. at 1259. 54 see vickers v. nash gen. hosp., inc., 78 f.3d 139, 140 (4th cir. 1996); urban v. king, 43 f.3d 523, 525-26 (10th cir. 1994); cleland, 917 f.2d at 268-69; gatewood, 933 f.2d at 1041. 55 see eberhardt, 62 f.3d at 1259. 56 42 u.s.c. § 1395dd(e)(3)(a). 57 id. § 1395dd(b)(2). 58 id. § 1395dd(b)(3). 59 id. § 1395dd(b). 802 vol. 11:2 2014 rejecting patient admittance under emtala a hospital must stabilize the patient prior to transfer to another hospital60 unless: (1) a patient, after acknowledging the risks of transfer, requests the transfer in writing; (2) the physician determines the benefits of immediate transfer will outweigh the risks and then signs a certification; or (3) the physician determines the benefits of immediate transfer will outweigh the risks and then a qualified medical person, in consultation with the physician, signs a certification.61 the hospital also need not stabilize a patient prior to transfer if the transfer qualifies as an "appropriate transfer." 62 an appropriate transfer is one in which (1) the transferring hospital has minimized the risks of transfer by treating the patient within its capacity; (2) the receiving facility has the available resources for treatment and has agreed to accept the patient; (3) the transferring hospital has sent the receiving hospital the necessary medical records and other related documents; (4) the transfer is accomplished by qualified personnel; and (5) the procedure meets all other standards in the interest of the health and safety of the patient.6 3 c. enforcement of emtala any individual who is harmed as a result of a hospital's violation of the statute may, "in a civil action against the participating hospital, obtain those damages available for personal injury under the law of the state in which the hospital is located." 64 any hospital in violation of a provision of emtala is "subject to a civil money penalty of not more than $50,000 [or not more than $25,000 in the case of a hospital with less than 100 beds] for each such violation." 65 a physician who is responsible for the examination, treatment, or transfer of the patient and who negligently violates the statute by transferring a patient 60 id. § 1395dd(c)(1). 61 id. § 1395dd(c)(1)(a)()-(iii). 62 id. § 1395dd(c)(1)(b). 63 id. § 1395dd(c)(2)(a)-(e). 64 id. § 1395dd(d)(2)(a). 65 id. 803 indiana health law review where the physician knew the risks outweighed the benefits or misrepresents an individual's condition is "subject to a civil money penalty of not more than $50,000 for each such violation."66 an individual harmed by a direct violation of the statute or a hospital suffering financial loss resulting from a direct violation of the statute may initiate a civil action against the hospital at fault.6 7 the key mechanisms for the enforcement of emtala are the monitoring efforts of the department of health and human services ("hhs") and claims made by private individuals. 68 hhs enforces emtala requirements through the centers for medicare & medicaid services (cms)69 and the office of inspector general (oig).70 if a 66 id. § 1395dd(d)(1)(b). 67 id. § 1395dd(d)(2). this section provides: (2) civil enforcement (a) personal harm any individual who suffers personal harm as a direct result of a participating hospital's violation of a requirement of this section may, in a civil action against the participating hospital, obtain those damages available for personal injury under the law of the state in which the hospital is located, and such equitable relief as is appropriate. (b) financial loss to other medical facility any medical facility that suffers a financial loss as a direct result of a participating hospital's violation of a requirement of this section may, in a civil action against the participating hospital, obtain those damages available for financial loss, under the law of the state in which the hospital is located, and such equitable relief as is appropriate. id. 68 julia ai, does emtala apply to inpatients located anywhere in a hospital., 32 rutgers l.j. 549, 556 (2001) (citing joan m. steiber & linda j. spar, emtala in the 90's enforcement challenges, 8 health matrix 57, 61 (1998)). 69 when emtala was enacted, prior to the creation of medicare and medicaid, the cms was called the health care financing administration (hcfa). 804 vol. 11:2 2014 rejecting patient admittance under emtala hospital is found to be in violation of emtala, the cms may terminate the hospital's medicare agreement 1 and the oig determines whether to impose civil penalties. 72 iv. emergence of the issue: the circuit split when a patient arrives at a hospital's emergency department, the hospital must provide an appropriate medical screening.73 if a physician identifies an emergency medical condition, then the hospital is obligated to stabilize the patient or transfer the patient to another facility if necessary.74 in many cases, a patient with an emergency medical condition will be admitted to the hospital for further treatment and later discharged. while the statute mandates that patients in the emergency room with emergency medical conditions must be "stabilized" or "transferred," it does not specifically articulate how these obligations apply to patients who have been admitted to the hospital for further treatment and are no longer being cared for in the emergency department. more precisely, the statute does not expressly identify the point in time when hospitals have fulfilled their emtala obligations once a patient is admitted to the general hospital. this issue has been thoroughly considered since the enactment of emtala and three prominent and conflicting positions have been articulated by the sixth circuit, the fourth circuit, and the ninth circuit. a. the sixth circuit considers the issue: thornton v. southwest detroit hospital in 1990, the united states court of appeals for the sixth circuit addressed emtala's "stabilization" requirement in 70 ai, supra note 68, at 556 (citing lauren a. dame, the emergency medical treatment and active labor act: the anomalous right to health care, 8 health matrix 3, 11 (1998)). 71 42 c.f.r. § 489.24(g) (2013). 72 id. § 489.24(h)(3). 73 42 u.s.c. § 1395dd(a) (2014). 74 id. § 1395dd(b). 805 indiana health law review thornton v. southwest detroit hospital 75 the court affirmed the lower court's ruling that the hospital had fulfilled its emtala obligations by stabilizing the patient once she had come to the emergency department.76 in the case, upon the patient's arrival to the emergency department, physicians discovered that the patient had suffered a stroke and admitted her to the hospital's intensive care unit.77 the patient spent ten days in the intensive care unit and was treated for an additional eleven days in regular patient in-care. 78 because the patient could not afford to stay at the physician's preferred rehabilitation facility, the hospital discharged the patient to receive home care from her sister until another facility would accept her application.79 by the time the patient had gained admission to a new facility, two months had passed since her release from the hospital and her condition had seriously deteriorated.80 the patient brought a claim under emtala alleging that the hospital had failed to properly stabilize her condition prior to her discharge to home care.81 the district court granted the hospital's motion for summary judgment, and the patient appealed.82 although the hospital argued that emtala's stabilization requirement had been fulfilled once the patient had been admitted to the hospital's intensive care unit, the court found no basis for this contention.83 instead, the court stated that a literal interpretation of the statute prohibits a hospital from discharging a patient who came to the emergency department before the condition has been medically stabilized without regard as to whether the patient was admitted. 84 emphasizing this point, the court stated that "emergency care does not always stop when a 75 thornton v. sw. detroit hosp., 895 f.2d 1131, 1135 (6th cir. 1990). 76 id. 77 id. at 1132. 78 id. 80 id 81 id 82 id 83 id. at 1135. 84 id 806 vol. 11:2 2014 rejecting patient admittance under emtala patient is wheeled from the emergency room into the main hospital."85 this view reflects the common concern that permitting hospitals to fulfill the stabilization requirement through admission allows circumvention of ematala's mandate.8 6 hospitals would have an incentive to develop policies to regularly admit patients with emergency medical conditions in order to simply fulfill emtala requirements and then discharge the patient without concern for liability.87 after identifying the proper interpretation of emtala's stabilization provision, the court applied the facts of the case and held that the patient had been medically stabilized prior to discharge.8 8 the court affirmed the district court's grant of summary judgment on the grounds that no genuine issue of material fact existed as to the patient's medically stabilized condition.89 b. the fourth circuit weighs in: bryan v. rectors and visitors of university of virginia when the united states court of appeals for the fourth circuit addressed emtala's stabilization requirement in 1996, it came to a different legal conclusion regarding the proper interpretation of the statute. in bryan v. rectors and visitors of university of virginia, the court held that a hospital had not violated emtala when an admitted patient died after physicians gave orders to not resuscitate the patient following twelve days of treatment.9 0 in this case, the patient was presented with an emergency medical condition in the emergency room and was admitted to the hospital.9 ' the physicians provided proper treatment but failed to ever medically stabilize the patient. twelve days after the patient's admittance, physicians entered a "do not 85 id 86 id 87 id 88 id 89 id 90 bryan v. rectors and visitors of univ. of va., 95 f.3d 349, 353 (4th cir. 1996). 91 id. at 350. 807 indiana health law review resuscitate order" against the family's wishes. 92 during her next respiratory episode, the patient was not given stabilizing treatment and died as a result.93 the patient's family brought a claim asserting that emtala imposed an obligation on hospitals to -treat patients for emergency medical conditions and, if needed, admit the patient and then continue to treat the patient's condition, no matter how long treatment was required to maintain a stabilized condition. 94 the court flatly disagreed, and instead it stated that emtala's purpose was to ensure that hospitals provide stabilizing treatment to patients with emergency medical conditions.9 5 once a patient was admitted, a physician's failure to treat would be regulated by state tort law.96 in coming to this conclusion, the court examined the statute's definition of "to stabilize," which means "to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual."97 the court interpreted this to mean that stabilization was only required in conjunction with an anticipated transfer and that the statute was "without any reference to the patient's long-term care within the system."9 8 therefore, the stabilization requirement was "intended to regulate the hospital's care of the patient only in the immediate aftermath of the act of admitting her for emergency treatment and while it considered whether it would undertake longer-term full treatment or instead 92 id. 9 id. 94 brief of appellant at 5, bryan v. rectors and visitors of univ. of va., 95 f.3d 349 (4th cir. 1996) (no. 95-2023) (contending "[ilf a hospital . . . accepts a patient with an emergency medical condition either by admission or transfer and continues stabilizing treatment for any period of time, whether it be one hour, one week or twelve days and then refuses such stabilizing treatment, such refusal of stabilizing treatment without transfer violates emtala."). 96 id. at 351. 96 id. at 351-52. 97 id. at 352. 9s 8id 808 vol. 11:2 2014 rejecting patient admittance under emtala transfer the patient to a hospital that could and would undertake that treatment."99 the court emphasized that an individual may not bring an emtala claim if the patient was receiving stabilizing treatment and was never discharged or transferred, regardless of whether the patient was ever considered medically "stable." 00 although the court clarified that an emtaia violation could not occur if the patient had not been transferred, it also adopted the view that emtala's obligations are fulfilled once a patient is admitted. c. the supreme court's most recent emtala ruling. roberts v. galen of virginia, inc. in 1999, the united states supreme court granted certiorari to decide an emtala issue in roberts v. galen of virginia, inc. 0 1 although the issue was relevant to the circuit split emerging in the sixth and fourth circuits, roberts addressed only the narrow issue of whether a claim alleging a violation of emtala's stabilization duty required the plaintiff to show that the violation was the result of the hospital's improper motive. 102 the supreme court held that proving the hospital's improper motive was not required to succeed in a claim of this nature stating, "there is no question that the text of [the stabilization provision] does not require an 'appropriate' stabilization, nor can it reasonably be read to require an improper motive."s0 3 thus, when an individual brings an emtala claim asserting that a hospital failed to properly stabilize a patient, the individual need not prove that the failure resulted from a medical professional's improper motive. this releases patients from the difficult task of proving a subjective element such as intent. while the court clarified some issues relating to the stabilization requirement, the s9 id. 1oo id. at 353. 101 roberts v. galen of virginia, inc., 111 f.3d 405 (6th cir. 1997). 102 roberts v. galen of virginia, inc., 52 u.s. 249, 252 (1999). 103 id. at 253. 809 indiana health law review limited opinion failed to weigh in on the hospital's emtala obligation once a patient has been admitted. d. the ninth circuit creates a new standard.' bryant v. adventist health system/west in 2002, the united states court of appeals for the ninth circuit addressed the issue in bryant v. adventist health system/west. 104 the court affirmed the district court's holding that a hospital had fulfilled emtala's stabilization requirement by admitting the patient to the general hospital. 05 the patient, a minor who was severely mentally disabled, came to the emergency room with pneumonia, an emergency medical condition. 06 the patient was admitted to the hospital and although treated and recommended for discharge, a last-minute examination of the patient's chest x-ray revealed a lung abscess. 07 the physicians re-admitted the patient and transferred him to an intensive care unit at another hospital because there were no beds available at the original hospital.108 the receiving hospital performed surgery and eventually discharged the patient approximately two weeks after transfer. 109 although he seemed to be improving, the patient died unexpectedly nine days later. 0 among other claims, the complaint alleged that the receiving hospital violated emtala's stabilization requirement by failing to stabilize the patient prior to discharge."' to determine whether the hospital could be held liable, the court had to "decide when emtala's stabilization requirement ends." 112 the court first considered the fourth circuit's stance that the stabilization 104 bryant v. adventist health sys./west, inc., 289 f.3d 1162 (9th cir. 2002). 105 id 106 id. at 1164. 107 id 108 id. 109 id. 110 id. 111 id. at 1163. 112 id.at 1167. 810 vol. 11-2 2014 rejecting patient admittance under emtala requirement was not meant to apply to patients admitted to the hospital. 113 then the court considered the sixth circuit's stance that emtala's stabilization requirement is not limited to the emergency room and follows a patient until he or she has been stabilized or transferred, no matter how much time passes.114 based on the statute's purpose of preventing patient dumping, the court determined that the hospital's obligation to stabilize ends when the patient is admitted. 115 the court expressed concern that if stabilization was required after the patient was admitted, there would be "anomalous result-patients" who, if treated in the emergency room first, would be protected by emtala even after admission, but patients who by-passed the emergency room would not be entitled to these protections. 6 however, paying lip-service to the sixth circuit's concern that hospitals may admit patients to escape liability under emtala with no intent to properly stabilize, .the court created an exception.117 the court provided that, although it would "not assume that hospitals use the admission process as a subterfuge to circumvent the stabilization requirement of emtala," if a patient could demonstrate that his or her particular admission was a ruse, then liability may attach." 8 therefore, if a patient wishes to bring an emtala claim asserting improper stabilization, and the patient was admitted to the hospital following an emergency department examination, then the patient must prove the admission was improperly motivated. e the cms regulations adopt the ninth circuit's approach in 2003, the cms promulgated regulations in an attempt to remedy the varied rulings on emtala's stabilization 113 id. 114 id at 1167-68. 115 id at 1168. 116 id. at 1169. 117 id 118id 811 indiana health law review requirement. the regulations reaffirmed the statute's language regarding stabilization, but they created an exception applicable to inpatients that addressed the circuit split.119 the regulation states: if a hospital has screened an individual . . . and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual. 120 the regulation adopts the ninth circuit's position and, like the court in bryant, provides an exception when patient admittance is determined to be a subterfuge by including the "good faith" language. in coming to this determination the authors commented, "[wle believe that, as the agency charged with enforcement of emtala, it is appropriate to pay deference to the numerous federal courts of appeal that have decided upon this issue."121 although the final rule is unambiguous, the cms struggled in reaching this conclusion. in fact, the originally proposed rule, published in the federal register in may of 2002, had adopted the exact opposite position. the proposed regulation stated, "admitting an individual whose emergency medical condition has not been stabilized does not relieve the hospital of further responsibility to the individual."122 instead, it required that "the individual's condition must be such that no material deterioration of the 119 42 c.f.r. § 489.24(a)(1)(ii) (2013). 120 id. § 489.24(d)(2)(i). 121 medicare program; clarifying policies related to the responsibilities of medicare-participating hospitals in treating individuals with emergency medical conditions, 68 fed. reg. 53222-01, 53244 (proposed sept. 9, 2003) [hereinafter clarifying policies] (making this conclusion following an exhaustive analysis of bryant and its progeny.). 122 medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2003 rates, 67 fed. reg. 31404-01, 31475 (proposed may 9, 2002). 812 vol. 11-2 2014 rejecting patient admittance under emtala condition is likely, within reasonable medical probability, to result from or occur during a transfer."123 the proposal cited a strict reading of the statute and the fear of systematic circumvention as the basis for coming to this conclusion. 124 one commentator approvingly stated "this clarification will allow hospitals to find an endpoint to their emtala obligations, specifically when the patient's emergency [medical] condition is stabilized."12 5 the cms's later about-face was the result of extensive "comments" on the proposed rule and supposed deference to the circuit courts. 126 as recently as february of 2012, the cms has affirmed the 2003 regulations in a new set of proposed rules.127 the cms stated "[wle continue to believe that this policy is a reasonable interpretation of the emtala statute and is supported by several federal courts that have held that an individual's emtala protections end upon admission as a hospital inpatient."128 this affirmation indicates the cms's firm commitment to ending emtala's stabilization obligation when a patient is admitted to the hospital, and it signifies the improbability of a policy change in the near future. 123 id 124 id. (stating pointedly that "permitting inpatient admission to end emtala obligations would provide an obvious means of circumventing these requirements that would seemingly contradict the point of the statute to protect emergency patient health and safety. this point should be particularly evident in the case of a woman in labor, a central focus of the statute. such women are frequently admitted, and the statute clearly contemplated protecting them until completion of the delivery (that is, stabilization). in addition, if an inpatient who had been admitted from the dedicated emergency department with an unstabilized emergency medical condition was never stabilized as an inpatient and is transferred, we would still apply emtala in reviewing the transfer. in this context, stability for transfer reflects a complex medical judgment that can be made only based on review of all relevant information in each particular case, including all conditions that could cause the patient to be medically unstable."). 125 clarifying policies, supra note 121, at 53244. 126 id. at 53245. 127 medicare program; emergency medical treatment and labor act (emtala): applicability to hospital inpatients and hospitals with specialized capabilities, 77 fed. reg. 5213-01 (proposed feb. 2, 2012). 128 id. at 5217. 813 indiana health law review f the sixth circuit responds: moses v. providence hospital and medical centers, inc. in 2009, the issue of emtala's stabilization requirement was once again in front of the united states court of appeals for the sixth circuit. in moses v. providence hosp. and medical centers, inc., the sixth circuit addressed the issue for the first time since the cms released the 2003 regulations. 129 following its ruling in bryant and disregarding the cms regulations, the court reversed the district court's order granting summary judgment and held that admittance into an inpatient care unit at a hospital was not sufficient to fulfill the hospital's stabilization requirement under emtala.130 the chilling background of this case began on december 13th when the patient's wife brought her husband to the hospital's emergency department due to severe headaches, muscle soreness, high blood pressure, and vomiting.131 the patient also displayed signs of slurred speech, disorientation, hallucinations, and delusions and had reportedly "demonstrated threatening behavior" causing the wife to be "fearful of her safety." 132 the patient was admitted to the hospital for further testing.133 over the next few days, the patient exhibited more concerning psychiatric symptoms and had allegedly told his wife he "had bought caskets."134 the physicians also learned that the patient had recently attempted to board a plane with a hunting knife.135 with this information and the results from other tests, the physicians ruled out an acute psychotic episode and planned to transfer the patient to the psychiatric unit for reassessment, "if the patient's insurance will accept" the charge. 136 although the transfer was 129 moses v. providence hosp. and med. ctrs., inc., 561 f.3d 573, 584 (6th cir. 2009). 130 id 131 id. at 576. 132 id 133 id. 13 id. 135 id 136 id 814 vol. 11:2 2014 rejecting patient admittance under emtala arranged on december 17th because the patient was not "medically stable from a psychiatric standpoint," the patient was abruptly told he would be discharged on december 18th. 3 7 in the discharge papers a physician stated that the patient was stable, and he was released on. december 19th.1a8 on december 29th, ten days after his release, the patient murdered his wife. 39 among the many claims asserted, the decedent's representatives alleged that the hospital failed to stabilize the patient prior to his discharge, violating the stabilization requirement under emtala.140 the hospital filed a motion for summary judgment, claiming that, as a matter of law, it had fulfilled the stabilization requirement by admitting the patient to the hospital. 141 the trial court granted the hospital's motion for summary judgment based on the patient's admittance.142 the trial court found that because the patient had received a proper medical screening and was subsequently admitted to the hospital, no genuine issues of material fact remained. 143 the patient's representatives appealed.144 the united states court of appeals for the sixth circuit reversed the lower court's holding with respect to the hospital.145 the court rejected the hospital's argument and held that "emtala imposes an obligation on a hospital beyond simply admitting a patient with an emergency medical condition to an inpatient care unit."146 the court began by reciting the relevant parts of the statute. when a patient is found to have an emergency medical condition, the hospital must provide "such treatment as may be required to stabilize the medical condition."147 a patient is 137 id. 138 id. at 577. 139 id. at 576-77. 140 id. at 577. 141 id 142 id 143 id. at 578. 144 id 145 id. at 576. 146 id. at 582. 147 id 815 indiana health law review stabilized when "no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during transfer."148 "'transfer' is defined in the statute to include moving the patient to an outside facility or discharging him." 149 furthermore, emtala restricts transfer-which includes discharge-until the patient is stabilized. 150 therefore, the court found that "emtala requires a hospital to treat a patient with an emergency [medical] condition in such a way that, upon the patient's release, no further deterioration of the condition is likely." 151 stated differently, fulfillment of emtala's stabilization requirement is based exclusively on the patient's medical condition. the court next addressed the hospital's argument that the cms regulation allowed patient admittance to fulfill emtala's stabilization requirement. the court began by noting that regulations promulgated by administrative agencies may be rejected if they are contrary to clear congressional intent.152 the court assessed congressional intent based on the language of the stabilization provision and the corresponding definitions and found that allowing admission to fulfill the stabilization requirement conflicted with the statute. 153 because the court found the cms regulation to be contrary to the statute's plain language, the court rejected the regulation and did not afford it deference.15 4 148 id. 149 id. at 579. 150 id 151 id. at 582. 152 id. at 583 (quoting gallagher v. croghan colonial bank, 89 f.3d 275, 277-78 (6th cir. 1996). 153 id 154 id. at 583-84. following the deference analysis, the court brought attention to the fact that the events of the case occurred in december of 2002, months before the cms regulations were published in 2003. id. at 583. the court stated, "[elven if the cms regulation could somehow be deemed consistent with the statute, its promulgation in 2003, after [the patient's] stay in the hospital ended, would preclude this court from applying it to this case." id. this is true because the regulation is silent on retroactivity, and retroactive application would unfairly attach legal consequences to events completed prior to its enactment. id. at 584. 816 vol. 11:2 2014 rejecting patient admittance under emtala v. discussion the fourth circuit represents the view that emtaia's stabilization requirement is fulfilled when a patient is admitted to the hospital. 155 the ninth circuit is aligned with the fourth circuit, but it provides an exception so that if a patient can prove he or she was admitted for the sole purpose of circumventing emtala's stabilization requirement, the hospital may still be held liable.15 6 lastly, the sixth circuit represents the view that stabilization is only fulfilled when a patient's condition is not likely to deteriorate upon transfer or discharge. 157 therefore, according to the sixth circuit, a patient's admittance to an inpatient care unit is irrelevant in determining if the hospital fulfilled its stabilization duty. 158 the sixth circuit's interpretation should be followed because it represents the plain meaning of the statute, honors the legislative intent, and provides consistency with the united states supreme court's holding in roberts v. galen of virginia, inc. a. rejecting the cms regulations the sixth circuit was permitted to hold contrarily to the 2003 cms regulations because the language of emtala was not ambiguous and the regulation was adverse to legislative intent. the purpose of the release of the 2003 cms regulations was to clarify the duty emtala conferred upon hospitals regarding stabilizing treatment provided to although the court mentions this issue-determinative fact, the court's primary analysis is not weakened because it does not rely on the lack of retroactivity to come to its ultimate conclusion regarding deference to the cms regulation. id. 155 see bryan v. rectors and visitors of univ. of va., 95 f.3d 349, 352 (4th cir. 1996). 156 see bryant v. adventist health sys./west, 289 f.3d 1162, 1169 (9th cir. 2002) 157 see moses, 561 f.3d at 579. 158 id. 817 indiana health law review patients in the emergency department. 159 by allowing hospital admittance to fulfill the statute's stabilization requirement, the cms created a bright line rule for hospitals to follow and courts to enforce. five years later, the sixth circuit held contrarily to the regulations, defying the cms's newly established approach to emtala's stabilization requirement. 160 while the regulations specifically stipulated that emtala's stabilization requirement ends when a patient is admitted, the sixth circuit held that the cms had improperly interpreted emtala and that admittance did not necessarily qualify as fulfillment of the stabilization requirement.16 1 when issues of statutory construction arise, courts must first inquire "whether congress has directly spoken to the precise question at issue." 162 if congress has articulated an exact position in the plain meaning of the statute, then the court "must give effect to the unambiguously expressed intent of congress."163 if the statute is silent on the issue or provides ambiguous language regarding the issue, then the court must look for guidance from any regulations promulgated by an agency charged with administering the statute. 164 the court must then consider "whether the agency's answer is based on a permissible construction of the statute." 165 in making this determination, the court should give a degree of deference to the administrative agency. 166 the court is bound to follow the agency's statutory interpretation as long as it constitutes a "permissible construction of the statute."167 it follows that 159 clarifying policies, supra note 121, at 53244 (explaining generally that "[t]he final rule responds to public comments received on a may 9, 2002 proposed rule (67 fr 31404) that both reiterated the agency's interpretations under emtala and proposed clarifying changes relating to the implementation of the emtala provisions."). 160 see moses, 561 f.3d at 573. 161 id. 162 chevron, u.s.a., inc. v. natural res. def. council, inc., 467 u.s. 837, 842 (1984). 163 id. at 843. 164 id. 165 id. 166 id. at 843-44 167 id. at 843. 818 vol. 11:2 2014 rejecting patient admittance under emtaia "[t]he judiciary is the final authority on issues of statutory construction and must reject administrative constructions which are contrary to clear congressional intent." 168 congressional intent may be discerned by the plain meaning of the statutory language or, if the language is ambiguous, by the legislative history surrounding the enactment of the statute.169 in the case of emtala, the sixth circuit was permitted to determine whether congress spoke directly to the stabilizing issue in the statute. if the court found direct language providing an exact position within emtaia, then the court was required to give effect to the mandate of congress.170 on the other hand, if the sixth circuit found the language relating to stabilization to be ambiguous or lacking, only then was the court permitted to consider any relevant regulations, in this case those published by the cms.171 before accepting cms's regulations as binding, the sixth circuit had to decide whether the cms regulations were based on a permissible construction of emtala, while giving proper deference to the cms. finally, the court was permitted to discard the cms regulations if they appeared contrary to congressional intent as understood through the plain meaning of the statute and congressional records. b. plain meaning emtaia's plain meaning, construed from the language of the statute, requires hospitals to stabilize patients prior to discharge or transfer, and it does not expressly limit hospital liability by ending the stabilization requirement once a patient is admitted.17 2 the statute provides that 168 id. at 843 n.9. 169 see id. at 842-43 (providing a general framework for determining legislative intent by first examining the statutory language and then various congressional records). 170 see id. 171 see id. 172 42 u.s.c. § 1395dd(b)(1) (2014). the statute provides: (1) in general 819 indiana health law review when a patient is found to have an emergency medical condition, the hospital must provide "such further medical examination and such treatment as may be required to stabilize the medical condition" or "transfer of the individual to another medical facility."173 the statute thus contemplates "stabilization" in terms of medical treatment but not administrative procedures such as admittance. according to the statute, the definition of "to stabilize" is "to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility." 174 transfer means "the movement [including the discharge] of an individual outside a hospital's facilities at the direction of any person employed by... the hospital."17 5 therefore, a patient must be provided with enough medical treatment as may be necessary to reasonably assure the medical condition will not deteriorate once a patient is transferred to another hospital or discharged. this makes clear that the obligation emtala imposes may only be fulfilled when a patient has received the appropriate medical care.176 because the statute makes no reference to limiting this care to patients in the emergency room, a patient's admittance into an inpatient if any individual (whether or not eligible for benefits under this subchapter) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either-(a) within the staff and facilities available at the hospital, for such further medical examination and such treatment as may be required to stabilize the medical condition, or (b) for transfer of the individual to another medical facility in accordance with subsection (c) of this section. 173 id. § 1395dd(b). 174 id. § 1395dd(e)(3)(a). 175 id. § 1395dd(e)(4). 176 see thornton v. sw. detroit hosp., 895 f.2d 1131, 1134 (6th cir. 1990). 820 vol. 11:2 2014 rejecting patient admittance under emtala care unit is irrelevant in determining whether emtala's stabilization requirement has been fulfilled.177 furthermore, a comparison of the medical screening requirement found in section (a) and the stabilization requirement found in section (b) suggests that the statute contemplates patients being admitted to the hospital in order to satisfy the required stabilizing treatment. 178 the statute requires patients who come to the "hospital emergency department" to be screened to determine whether an emergency medical condition exists. 179 once an emergency medical condition has been identified, the "hospital" must provide the necessary stabilizing treatment to the patient. 180 while the screening requirement is assigned to the hospital emergency department, the stabilization requirement is assigned simply to the hospital. 181 this change in wording indicates a change in meaning within the statute, particularly that stabilizing treatment in accordance with the provision must be provided, regardless of whether the patient is admitted to the general hospital.182 because the cms regulation is in direct conflict with the statute's plain meaning, the sixth 177 this reasoning is consistent with court decisions finding that emtala applies not just to patients who are indigent, uninsured or otherwise unable to pay, but to all patients who come to the emergency department. in those cases, the courts found that clear language and a lack of provisions stating otherwise indicated that emtala applied to all patients in the emergency department. see, e.g., cleland v. bronson methodist hosp., 917 f.2d 266, 269 (6th cir. 1990); power v. arlington hosp. ass'n, 42 f.3d 851, 857 (4th cir. 1994); summers v. baptist med. ctr. arkadelphia, 91 f.3d 1132, 1137 (8th cir. 1996). the court in cleland stated that although, "nothing in the legislative history show [ed] that congress had any concern about the treatment accorded any patients other than the indigent ... congress wrote a statute that plainly has no such limitation." cleland, 917 f. 2d at 269. 178 see thornton, 895 f.2d at 1134. 179 42 u.s.c. § 1395dd(a). 180 id. §1395dd(b)(1). 181 id. § 1395dd(a)-(b). 182 thornton, 895 f.2d at 1134 (concluding "[t]he reasonable inference from this change in wording is that once a patient is found to suffer from an emergency medical condition in the emergency room, she cannot be discharged until the condition is stabilized, regardless of whether that patient stays in the emergency room."). 821 indiana health law review circuit is not required to give deference to the administrative agency's statutory construction. c. legislative intent even if the statute is assumed to be ambiguous, the legislative intent behind emtala supports the sixth circuit's holding in moses. as articulated in congressional reports, emtala was enacted to address the "the provision of adequate emergency room medical services to individuals who seek care." 183 particularly, congress was concerned with hospitals' failure to provide treatment to patients coming to the emergency department, which resulted in medically inappropriate transfers or discharges.184 the renewed interest in indigent care was the result of numerous reports indicating that patients without insurance were simply not treated or transferred to another facility regardless of the patient's condition and without notifying the receiving hospital. 185 congress addressed the reports stating: there is some belief that this situation has worsened since the prospective payment system for hospitals became effective. the committee wants to provide a strong assurance that pressures for greater hospital efficiency are not to be construed as license to ignore traditional community responsibilities and loosen historic standards. [under the statute] [a~ll participating hospitals with emergency departments would be required to provide an appropriate medical screening examination for any individual who requests it 183 h. r. rep. no. 99-241, pt. 3, at 5 (1985), reprnted in 1986 u.s.c.c.a.n. 726, 727. 184 id. at 743 (articulating that "[s]tabilization includes adequate evaluation and initiation of treatment to assure the transfer of a patient will not, within reasonable medical probility [sic], result in death, or loss or serious impairment of bodily parts or organs."). 185 h. r. rep. no. 99-241, pt. 1, at 27 (1985), reprinted in 1986 u.s.c.c.a.n. 579, 605. 822 vol. 11:2 2014 rejecting patient admittance under emtala . . . to determine whether an emergency medical condition exists or if the patient is in active labor. 86 the legislature summarized its position stating it was "most concerned that medically unstable patients [were] not being treated appropriately."187 some courts have asserted that emtala was enacted to "prevent a distinct and rather narrow problem of patient dumping, or the practice of refusing to admit or summarily transferring a patient based on a perceived inability to pay for hospital services."188 this line of cases stands for the proposal that emtala's primary purpose was to prohibit hospitals from refusing to initiate medical care in the emergency room for uninsured patients. 189 these cases contend that emtala does not exist to regulate the actual treatment patients receive, but rather, it exists to ensure that hospitals do not turn patients away. 190 although emtala does address patient dumping, based on the legislative history, congress was concerned with more than compelling hospitals to receive indigent patients into the emergency room. in fact, the statute does not mention indigent patients, and courts have held that emtaia 186 id 187 id. (providing "[t]he committee wants to provide a strong assurance that pressures for greater hospital efficiency are not to be construed as license to ignore traditional community responsibilities and loosen historic standards.") 188 james v. jefferson reg'1, no. 4:12cv267 jar, 2012 wl 1684570, *3 (e.d. mo. may 15, 2012); see also bryan v. rectors and visitors of univ. of va., 95 f.3d 349, 352 (4th cir. 1996); summers v. baptist med. ctr. arkadelphia, 91 f.3d 1132, 1132 (8th cir. 1996); hunt v. lincoln mem'l hosp., 317 f.3d 891, 894 (8th cir. 2003); vickers v. nash gen. hosp., inc., 78 f.3d 139, 142 (4th cir. 1996). 189 bryan, 95 f.3d at 352 (concluding "emtala seeks to achieve the limited purpose of its enactment by requiring that the hospital provide limited stabilizing treatment to or an appropriate transfer of any patient that arrives at with an emergency condition."). 190 see jefferson reg', 2012 wl 1684570, at *3; see also danielle sapega, federal code blue: the emergency medical treatment and active labor act's prolonged venture into malpractice law, 29 temp. j. sci. tech. & envtl. l. 99 (spring 2010). 823 indiana health law review applies to all individuals who come to the emergency department. 191 the legislature was equally concerned with ensuring that hospitals did not turn indigent patients away as it was concerned with providing adequate treatment once a patient was accepted into the emergency department.192 d. policy concerns in addition to examining legislative intent based on the plain meaning of the statute and the congressional record, it is also important to consider the policy implications of emtala's provisions. of concern are the statute's interaction with state medical malpractice legislation and the interplay between the proper interpretation of the stabilization requirement and the supreme court's holding in roberts v. galen of virginia inc. under the sixth circuit's interpretation, state medical malpractice legislation is left undisturbed and the stabilization requirement is consistent with supreme court precedent. 1. the sixth circuit's approach does not supplant state medical malpractice laws courts have universally held that emtala was not enacted as a federal medical malpractice statute and that it does not provide a federal standard of care. 193 therefore, 191 see cleland v. bronson methodist hosp., 917 f.2d 266, 269 (6th cir. 1990) (stating that although some argue emtaila should only apply to the indigent, "congress wrote a statute that plainly has no such limitation on its coverage."); power v. arlington hosp. ass'n, 42 f.3d 851, 857 (4th cir. 1994) (noting "[t]he language of subsection 1395dd(a) simply refers to 'any individual' who presents to the emergency room."); roberts v. galen of va., inc., 525 u.s. 249, 252 (1999) (finding that proof of an improper motive, such as the patient's inability to pay for medical services, was not required for a failure to stabilize claim under emtaia.) 192 h.r. rep. no. 99-241, pt. 3, at 5 (1985), reprinted in 1986 u.s.c.c.a.n. 726, 727 (describing the general medical obligations that hospitals must fulfill when treating a patient who comes to the emergency department). 193 see holcomb v. monahan, 30 f.3d 116, 117 (11th cir. 1994) (stating "[slection 13995dd(a) is not designed to redress a negligent diagnosis by the 824 vol. 11:2 2014 rejecting patient admittance under emtala emtala should not be considered a substitute for state law medical malpractice claims. 194 this universal understanding of the statute leads some commentators to assert that an extension of emtala coverage to hospital inpatients would allow the federal statute to supersede state medical malpractice laws already in place.195 indeed, in considering extending emtala protection to inpatients, the court in morgan v. n ms med. ctr., inc. remarked: this approach also seems vulnerable to abuse, inasmuch as it would allow for an open-ended, uncabined duration of the stabilization requirement with no logical limiting principle. under this line of reasoning, then, the stabilization duty could be imputed as extending indefinitely after a patient's admission and potentially poaching on regulatory territory patrolled by state malpractice law, an outcome which runs directly counter to the stated purpose of emtala.196 other courts have shared this concern and have ruled against allowing emtala to protect hospital inpatients.197 although a valid concern, this argument conflates the sixth circuit's approach to stabilization. the sixth circuit held that "a hospital may not release a patient with an emergency medical condition without first determining that the patient has actually stabilized, even if the hospital hospital; no federal malpractice claims are created."); summers, 91 f.3d at 1132. 194 see bryan, 95 f.3d at 352; power, 42 f.3d at 857. 195 see bryant v. adventist health sys./west, inc., 289 f.3d 1162, 1168-69 (9th cir. 2002) (commenting that congress enacted emtala to create a new cause of action not found in state tort law that seeks to remedy the failure to treat patients but not to duplicate preexisting protections.). 196 morgan v. n. ms med. ctr., inc., 403 f. supp. 2d 1115, 1129 (s.d. ala. 2005) affd sub nom. morgan v. n. mississippi med. ctr., inc., 225 f. app'x 828 (11th cir. 2007). 197 see bryant, 289 f.3d at 1169. 825 indiana health law review properly admitted the patient." 198 therefore, the sixth circuit's application of emtala to inpatients is contingent on the patient's transfer to another facility or discharge. emtala would not apply in a situation where the hospital was continuously treating an admitted patient but failed to achieve stabilization before the patient's death. this is consistent with the language of emtala which defines "stabilized" as meaning "no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility." 99 additionally, this approach embraces a policy that requires a hospital to properly treat a patient who comes to the emergency department before releasing the patient in order to prevent the widespread problem of patient dumping. the sixth circuit's approach has been misconstrued to apply to all cases where a patient has come to the emergency room and then been admitted to the hospital. 200 however, for inpatients to assert a valid emtala claim based on stabilization, the alleged violation must have occurred in conjuncture with transfer or discharge. 201 otherwise, the standard of care that binds medical professionals regulates claims of negligent treatment for 198 moses v. providence hosp. and med. ctrs., inc., 561 f.3d 573, 583 (6th cir. 2009) (emphasis added). 199 42 u.s.c. § 1395dd(e)(3)(b) (2014) (emphasis added). 200 for example, in the appellee's brief in bryant, the hospital argued that emtala did not apply to inpatients because state malpractice laws regulated medical and ethical treatment in those situations. brief of defendant-appellee at 22-23, bryant v. adventist health sys./west, inc. 289 f.3d 1162 (9th cir. 2002) (no. 00-16399). in support of its position, the appellee cited to hussain v. kaiser found health plan of mid-at. states, inc., a case in which a patient was brought to the emergency room, admitted to the hospital, and died the next day while being treated in the hospital. hussain v. kaiser found. health plan of mid-atl. states, inc., 914 f. supp. 1331, 1332 (e.d. va. 1996). however, the patient in hussain was not "transferred" within the meaning of emtala, so the stabilization requirement was not triggered and the only possible claim the patient could assert was medical malpractice. thus, the appellee's reliance on that case for the proposition that emtala's applications to inpatients would duplicate malpractice was ill-founded. 201 see 42 u.s.c. § 1395dd(b)(1)(a). 826 vol. 11:2 2014 rejecting patient admittance under emtala inpatients. although this distinction does not completely avoid a invasion of state medical malpractice law, it significantly reduces the overlap and distinguishes actions that give rise to emtala claims and actions that give rise to state medical malpractice claims. 2. the ninth circuit's approach is inconsistent with the supreme court's holding in roberts v. galen the ninth circuit's exception to ending emtala's stabilization requirement once a patient is admitted is inconsistent with the supreme court's holding in roberts v. galen of virginia inc. although the ninth circuit's ruling was in favor of allowing admittance to end the stabilization requirement, the court recognized the policy concerns highlighted in the sixth circuit's decision. the ninth circuit itself stated, "[wle agree with the sixth circuit that a hospital cannot escape liability under emtala by ostensibly 'admitting' a patient, with no intention of treating the patient, and then discharging or transferring the patient without having met the stabilization requirement." 202 instead of following the sixth circuit however, the court simply created an exception allowing inpatients to hold hospitals liable under emtala if they could demonstrate their admission was a "ruse to avoid emtala's requirements." 2 03 this places the burden on inpatients to prove that a physician acted with subjective intent to circumvent emtala by admitting the patient. not only is this an incredibly difficult standard to meet, it is also inconsistent with the supreme court's holding in roberts. although the roberts decision did not determine when emtala's stabilization requirement ended, it did decide a related issue. the court reversed the court of appeal's decision that held "in order to .recover in a suit alleging a violation of [emtala's stabilization requirement], a plaintiff must prove that the hospital acted 202 bryant, 289 f.3d at 1169. 203 id 827 indiana health law review with an improper motive in failing to stabilize."204 under the court of appeals ruling, even if a patient could objectively prove the hospital failed to meet the stabilization requirement by discharging or transferring the patient before the patient was medically stable, the patient would still be required to show the failure was the result of an improper motive. the supreme court rejected this ruling stating that the statute clearly did not require this showing of improper motive either expressly or implicitly.2 05 the ninth circuit requires this improper motive showing for a claim asserting a violation of emtala's stabilization requirement any time a patient has been admitted to the hospital. 206 because the roberts opinion rejected this evidentiary requisite to prove any violation of the stabilization requirement, it would likely reject the same requisite when asserting a stabilization violation after a patient has been admitted. the supreme court would hold that the statute cannot be reasonably read to require such proof of an improper motive to satisfy the ninth circuit's exception. because the supreme court would not accept the ninth circuit's exception, the ninth circuit's position would be exactly aligned with the fourth circuit, that is, the stabilization requirement is fulfilled when a patient is admitted to the hospital, without exception. as the ninth circuit concedes, this interpretation represents a statutory scheme that is vulnerable to circumvention of emtala's mandate. 207 therefore, the sixth circuit presents the optimal approach to emtala's stabilization requirement because it reflects the statute's purpose and is consistent with the supreme court's previous decisions. 204 roberts v. galen of va., inc., 525 u.s. 249, 250 (1999). an improper motive could be based on anything including indigency, race, or sex. 205 id. at 252 (stating "[blut there is no question that the test of [e1vitala's stabilization requirement provision] does not require an "appropriate" stabilization, nor can it be reasonably read to require an improper motive."). 206 see bryant v. adventist health sys./west, inc., 289 f.3d 1162, 1169 (9th cir. 2002). 207 see id. 828 vol. 11:2 2014 rejecting patient admittance under emtala vi. conclusion the sixth circuit's interpretation of emtala's stabilization requirement represents the approach that most accurately construes the statute's meaning and the legislature's intent. first, the plain meaning of the statute defines stabilization in terms of medical treatment, and it also provides no limitation restricting emtala's coverage to patients in the emergency department. in fact, the statute contemplates "stabilization" as requiring additional treatment in the general hospital. second, the legislative history indicates that congress was concerned with the denial of treatment to patients coming to the emergency department. mandating that emtala's protection follow patients who come to the emergency department throughout their stay at the hospital, even after admittance, guarantees patients will receive necessary treatment. next, emtala does not supplant state medical malpractice laws. an emtala claim only becomes available to a potential plaintiff once the patient has been discharged or transferred, while medical malpractice claims may be made when medical professionals are negligent in providing treatment. last, the ninth circuit's exception to its general holding would most likely be struck down by the supreme court, leaving the undesirable rule that anytime a patient was admitted, the stabilization requirement would be fulfilled, even when a hospital only admitted the patient to circumvent emtala. the sixth circuit's approach offers a rule that considers the possibility of improper motive while supporting the statute's overall goal of preventing patient dumping. 829 nurses providing anesmesia not a "laughing" matter: why indiana should not opt out of federal physician supervision of certified nurse anesthetists requirements kyle k. fairchild* i. introduction ...........••..••••......•.....•••.....••.•..•••••.•..•••.....••..••..•.•..••......•.. 282 a. the issue ................................................................................. 282 b. roadmap ................................................................................. 284 ii. history and background of certifffid registered nurse anesthetists •....••••..•••....••••.••.•.••.•••••••••...••••...••....••••••.•.••••••••••.•.••.•••••.•••• 285 a. history and development of the nurse anesthetist practice .. 285 b. educational/certification requirements and statutory recognition ................................................................................... 286 c. reimbursement ofcrna service ........................................... 289 ill. analysis of recent nurse anesthetist studies ....................... 290 a. anesthesiologist direction and patient outcome ................... 290 b. cost effectiveness analysis of anesthesia providers .............. 292 c. no harm found when nurse anesthetists work without supervision by physicians ............................................................ 296 n. opt-out state requirements, statutes, and regulations versus current similar indiana law ............................................... 298 a. opt-out requirements ............................................................ 299 b. challenged state regulations or opt-out decisions ............. 300 1. state law challenges .......................................................... 300 c. similarly situated opt-out states contrasted to indiana ....... 306 1. rural setting and hospital analysis ................................... 306 2. statutory or code regulation comparison of similarly situated states .......................................................................... 307 v. problems arising if indiana were to opt out of physician supervision ............................................................................................. 308 vi. solutions and conclusion: keep the status quo regarding supervision in indiana .......................................................................... 309 * j.d. candidate, 2012, indiana university robert h. mckinney school of law; b.s.b.a., 2008, xavier university. 282 indiana health law review [vol. 9:1 i. introduction nearly a decade ago, dr. barry gleimer, an orthopedic surgeon in new jersey, performed arthroscopic knee surgery on a twenty-eight year old man.1 arthroscopy is a common surgical procedure where incisions are made, and a pencil-sized camera is inserted through those incisions after utilizing local, regional, or general anesthesia? shortly after dr. gleimer performed the knee arthroscopy, the presiding nurse anesthetist-who at first failed to notice the patient turning blue from lack of oxygen-struggled to insert a breathing tube and quickly sought help from a nearby anesthesi­ ologist.3 due to the nurse anesthetist's inability to treat the patient during his desperate time, dr. gleimer's patient currently suffers from short-term memory loss.4 the resulting harm in the described procedure is conspicu­ ous; however, the medical knowledge disparity between certified registered nurse anesthetists (crnas) and anesthesiologists, in cases such as dr. gleimer's, is far more noteworthy than the memory loss itself. a. the/ssue anesthesiologists and nurse anesthetists commonly work together in operating rooms to sedate patients and ease pain, but cooperation between the two groups ends once outside the hospital doors.5 for years, these two interconnected medical professions have fought a bitter political battle over who should be sedating patients, under whose supervision, and for what compensation. 6 the battle intensified when, just before his term ended in 2001, president bill clinton, whose mother coincidently served as a nurse anesthetist for thirty-five years, wanted to remove supervision require­ ments. 7 as a result, president clinton approved a government rule giving more autonomy to nurse anesthetists.8 president clinton's approval was in response to a 1997 proposal by the health care financing administration 1. suzanne sataline, doctors oppose a nursing push: new jersey may ease seda­ tion oversight, wall st. j. (oct. 23, 2010), http://online.wsj.com/article/sb10001424052 7023043541 04575568093578513032.html. 2. knee arthroscopy, am. academy of orthopedic surgeons, aaos.com, http:!/ orthoinfo.aaos.org/topic.cfm?topic=a00299 (last updated mar. 201 0). 3. sataline, supra note 1. 4. sataline, supra note 1. 5. personal business; in this doctor-vs.-nurse debate, long, deep breaths, n.y. times (oct. 8, 2000), http://www.nytimes.com/2000/l0/08/business/personal-business-in­ this-doctor-vs-nurse-debate-long-deep-breaths.h1ml. 6. id.; rhonda rowland, u.s. ruling expected in bitter anesthesia battle, cnn.com (may 16, 2001 ), http://articles.cnn.com/2001-05-16/healtb/anesthesia.debate _l_ nurse­ anesthetists-physician-anesthesiologists-patient-safety? _s=pm:heal th. 7. todd s. purdum, virginia clinton kelley, 70, president's mother, is dead, n.y. times, jan. 7, 1994, at a22; amy goldstein, hhs delays rule on anesthesia oversight; clinton measure gave nurses autonomy, wash. post, may 18, 2001, at a29. 8. purdum, supra note 7; goldstein. supra note 7. 2012] physician supervision of certified nurse anestiietists 283 requesting that nurses be able to work by themselves, without doctor super­ vision, if allowed by state-specific law.9 upon clinton's departure from office, the bush administration de­ layed the clinton-approved nurse autonomy rule and planned to write a new rule reverting back to the requirement that nurse anesthetists could only administer anesthesia when supervised by a doctor.10 the possible rever­ sion sparked lobbying before congress from former senate majority leader, robert j. dole, and former democratic representative, tom downey, on behalf of the anesthesiologists, while former house speaker-designate, bob livingston, lobbied for the nurse-anesthetists.11 ultimately, the anesthesi­ ologists' representatives convinced president bush of the possible safety hazards and risks involved with nurses independently administering anes­ thesia.12 however, both tommy g. thompson, who was the secretary of health and human services, and president george w. bush were strong advocates for state autonomy; therefore, the bush administration crafted a supervision rule giving governors the option to avoid the supervision re­ quirement.13 the centers for medicare and medicaid services' (cms) final rule that was published in the federal register in november 2001 now allows state governors to opt out of reimbursement for crna activity, permitting crnas to practice without supervision if the opt-out is consistent with state law.14 thus, under the cms amended opt-out rule, patients, like dr. glei­ mer' s arthroscopic knee patient, may not have physician supervised crnas in hospitals, ambulatory surgical centers, or critical access hospitals/5 which could lead to more severe injuries than just short-term memory loss due to the nurse and doctor knowledge disparity. interestingly, recent studies have challenged the knowledge gap be­ tween anesthesiologists and nurse anesthetists by concluding that there is not a significant difference in the quality of care administered by crnas as compared to anesthesiologists.16 after evaluating six years of medicare data, two analysts at the research triangle institute, an independent, non­ profit research institute, recently recommended that nurse anesthetists 9. goldstein, supra note 7. 10. goldstein, supra note 7; rowland, supra note 6. 11. goldstein, supra note 7. 12. interview with barry glazer, anesthesiologist, st. francis hospital & health cen­ ters, in indianapolis, ind. (jan. 28, 2011 ). 13. goldstein, supra note 7. 14. medicare and medicaid programs; hospital conditions of participation: anesthe­ sia services, 66 fed. reg. 56,762, 56,763 (nov. 13, 2001) (to be codified at 42 c.f.r. pts. 416, 482, 485). 15. fact sheet concerning state opt-outs and november 13, 2001 cms rule, am. ass'n nurse anestiietists, http://www.aana.com/advocacy/stategovemmentaffairs/pages/ fact-sheet-conceming-state-opt-outs.aspx (last updated sept. 201 0). 16. editorial, who should provide anesthesia care?, n.y. times, sept. 7, 2010, at a22. 284 indiana health law review [vol. 9:1 should be able to administer anesthesia without any surgeon or anesthesiol­ ogist supervision.17 jerry cromwell, the study's co-author and health eco­ nomics fellow at' the research triangle institute, said, "[t]his study shows that patient safety is not compromised by the opt-out policy. using nurse anesthetists more broadly could save on health care costs because they typi­ cally earn less than anesthesiologists."18 the study's recommendation is based on a lack of evidence to confirm that opti:j;lf out of crna supervision has increased inpatient deaths or complications.1 currently, sixteen states, including five of interest in this note (cali­ fornia, colorado, iowa, washington, and wisconsin), have elected to opt out of reimbursement from cms for nurse anesthetist activity as of october 2010?0 as a result of the two most recent national studies dealing with crna safety and cost-effectiveness, state governors now have unequivocal evidence to persuade state medical and nursing boards to support a move to accept unsupervised nurses.21 nevertheless, under the 2001 cms amend­ ment, governors still need to discern and balance the quality of care given to anesthesia patients, cost-effectiveness of not having physician supervision, and patient access in rural settings.22 even if these factors are appraised, and opting out decreases state budgets, which is presently necessary in many states, the preemptive steps may not be enough to relieve patients of the risk of death or grave harin when a nurse anesthetist's treatment ability is challenged like that of the nurse in the aforementioned anecdote. b. roadmap this note discusses the cms final rule allowing for unsupervised nurse anesthetists to administer anesthesia if their state of practice has opted out of medicare reimbursement for such service. in order to facilitate a bet­ ter understanding of the nurse anesthetist practice, section ll explains the history and development of the certified registered nurse anesthetist prac­ tice, sets out the educational requirements necessary for certification as a 17. brian dulisse & jerry cromwell, no harm found when nurse anesthetists work without supervision by physicians, 28 health aff. 1469, 1469 (2010}; press release, rti international, nurse anesthetists working without doctor supervision provide safe care (aug. 3, 2010}, available at http://www.rti.orglpage.cfm?objectid=l9731dcd-c437dcaa-5de995f6c1d7e6fc. 18. rti international, supra note 17. 19. dulisse & cromwell, supra note 17. 20. am. ass'n nurse anesthetists, supra note 15. 21. press release, american association of nurse anesthetists, colorado becomes 16th state to opt out of physician supervision requirement for nurse anesthetist (sept. 28, 201 0}, available at http:/ /www.aana.com/newsandjournai/news/pages/09281 o-colorado­ becomes-16th-state-to-opt-out.aspx. 22. see press release, american association of nurse anesthetist, iowa becomes first state to opt out of federal anesthesia requirement (dec. 13, 2001), available at http://www.aana.com/news.aspx?id=714. 2012] physician supervision of certified nurse anestiietists 285 crna, examines how nurse anesthetists are dealt with in indiana, and pro­ vides crna reimbursement basics. section m analyzes the major, recent studies proposing eliminating supervision· of nurse anesthetists based on cost effectiveness and quality of care, while also providing the responses given by the american society of anesthesiologists to these. controversial studies. section iv introduces the requirements for a state to opt out of nurse anesthetist supervision and compares opt-out states' .. administrative code or statutes dealing with anesthesia regulation to indiana's correspond­ ing statutes. in particular, this section focuses on opt-out states' decisions that have been legally challenged for being inconsistent with state law, al­ lowing for a prediction of the consistency of indiana regulations if they were challenged. also, in addition to looking at state law consistency is­ sues, section iv analogizes a crna scope of practice challenge to further highlight the disparity in anesthesiologist and nurse anesthetist training. finally, sections v and vi lay out problems that would arise if indiana opt­ ed out of reimbursement and concludes indiana should keep the status quo for nurse anesthetist supervision, or in the alternative should ramp up recognition or certification requirements of certified registered nurse anes­ thetists. ii. history and background of certified registered nurse anesthetists in order to determine whether indiana should opt out of nurse anesthe­ tist supervision, an understanding of the development of the profession it­ self is essential. this section explains the practice of crnas in general, how the practice of nurse anesthetists developed, what educational and ex­ perience requirements are necessary to become certified as a nurse anesthe­ tist, different methods of recognizing the nurse anesthetist practice, and, finally, offers rudimentary background on crna reimbursement. a. history and development of the nurse anesthetist practice nurses, not anesthesiologists, were the first professional group to ad­ minister anesthesia in the united states, which led to the recogl!ition in the late 1800s of the first clinical nurse specialty, nurse anesthesia?3 for over 150 years, beginning with providing anesthesia to wounded soldiers during the civil war, nurses have been administering anesthesia in the united states?4 in addition to caring for soldiers, the development of the nurse 23. am. ass'n nurse anestiietists, nurse anesthetist: advancing patient safety and excellence in anesthesia (2010), available at http://www.aana.com/ aboutus/documentsllegalissuesnap.pdf (citing the history of nurse anesthesia practice sec­ tion of the compilation). 24. certified registered nurse anesthetists (crna.s) at a glance, am. ass'n nurse 286 indiana heal til law review [vol. 9:1 anesthetist occupation was also a response to surgeons' search for a solution to the high death rate during anesthesia in the late 1800s, as medical resi­ dents wanted to observe surgery, not give undivided attention to the administration of anesthesia?5 · by 1908, cleveland-based surgeon george crile asked a nurse, aga­ tha hodgins, to become his anesthetist. 26 hodgins became an expert at ad­ ministering anesthesia and began informally teaching others the anesthesia process, including english and french nurses who provided care to allied forces during world war 1.27 upon hodgins's return from the war, she established the lakeside hospital school of anesthesia in cleveland, ohio, a center that sent graduates across the country to provide nurse anesthesia care.28 soon thereafter, in 1931, hodgins brought her alumnae to cleve­ land and founded the national association of nurse anesthetists, which in 1939 became the american association ofnurse anesthetists (aana) and remains as such today. 29 at present, greater than ninety percent' of the na­ tion's nurse anesthetists0 of which over forty-one percent are men, are members of the aana. 3 later, in 1956, the official credential of certified registered nurse anes­ thetist was bom?1 beirig recognized as one of the first specialties within nursing, crnas acted with a high level of independence, accountability and responsibility.32 according to the aana, over 42,000 crnas across the country provide about thirty-two million anesthetics to patients each year.33 b. educational/certification ·requirements and statutory recognition in order to become a crna and be able to provide anesthetics, special education and experience requirements must be met. 34 these requirements include:35 1) earning a bachelor of science in nursing or other appropriate hacanes1hetists, http://www.aana.com/ataglance.aspx (last visited jan. 7, 2012). 25. am. ass 'n nurse anesthetists, supra note 23 (citing the history of nurse an­ esthesia practice section of the compilation). 26. id (citing the history of nurse anesthesia practice section of the compilation). 27. see the history of nurse anesthetists, am. ass'n nurse anes1hetists, http://www.anesthesiapatientsafety.com/na_glancelhistory.asp (last visited jan. 7, 2011 ). 28. am. ass'n nurse anesthetists, supra note 23 (citing the history of nurse anesthesia practice section of the compilation). 29. id (citing the history ofnurse anesthesia practice section of the compilation). 30. am. ass'n nurse anesthetists, supra note 24. 31. id. 32. see qualifications and capabilities of the certified nurse anesthetist, am. ass'n nurse anesthetists, http:/lwww.aana.com/ceandeducationlbecomeacma/pages/ qualifica­ tions-and-capabilities-of-the-certified-registered-nurse-anesthetist-.aspx (last visited jan. 8, 2012). 33. id 34. id 35. am. ass'nnursb anesthetists, supra note 24. 2012] physician supervision of certified nurse anesthetists 287 calaureate degree; 2) holding a current license as a registered nurse; 3) serving at least one year of experience as a registered nurse in an acute care setting or facility; 4) graduating with at least a master's degree from a council on ac­ creditation of nurse anesthesia educational programs accredited nurse an­ esthesia educational program;36 5) passing the national certification examination following graduation; and 6) recertifying on a biennial basis, which requires a current nursing license, forty hours of continuing education, certification that the nurse has been engaged in anesthesia practice for the previous two years, and verifica­ tion of no other problems that could adversely affect their practice of anes­ thesia.37 although these requirements are virtually standard nationwide, states may have different regulations or certifications that alter or eliminate such obligations.38 for example, indiana and michigan are the only two states that claim nurse anesthetists do not require additional certification in order to practice.39 in indiana, a crna "is properly certified by successfully completing the certification examination administered by the council on certification of nurse anesthetists or its predecessor."40 the indiana as­ sociation of nurse anesthetists interprets this certification provision as simply a definition, not a requirement to be additionally certified after pass­ ing the national examination by the council on certification of nurse anes­ thetists or other nationally recognized certifying body, as is required in all other states if a nurse wants to practice as a crna.41 indiana nurse anesthetists are also distinct because "indiana does not specify a specific method or process by which it authorizes nurse anesthe­ tists to practice,"42 whereas crnas are a type of"advanced practice nurse" or "advanced registered nurse practitioner" in the majority of states in this country.43 under indiana's advance practice nurse act, which deals with nurses obtaining additional skills through a specialized program to provide patient care in collaboration with the health care team, only nurse practi36. am. ass'n nurse anestiietists, supra note 32. 37. id. 38. see generally requirements, am. ass'n nurse anesthetists, http://www. aana.com/ceandeducationlbecomeacmaipages/requirements.aspx (last visited jan. 8, 20 12). 39. id. 40. ind. code§ 25-23-1-1.4 (2011 ). 41. am. ass'n nurse .anestiietists, supra note 38. 42. am. ass'n nurse anesthetists, statijtory/regulatory nurse anesthetist recognition, available at http://www.aana.com/advocacy/stategovemmentaffairs /documents/recognition. pdf. 43. seeid. 288 indiana healrn law review [vol. 9:1 tioners, nurse midwives, and clinical nurse specialists are mentioned.44 be­ cause of their exclusion, nurse anesthetists believed the stricter collabora­ tion requirements required of advance practice nurses would not apply to the~ which would give them more autonomy to practice without supervi­ sion. 5 however, under the indiana code, a crna may only administer anesthesia "[i]f the certified registered nurse anesthetist acts under the di­ rection of and in the immediate presence of a physician.'.46 therefore, even though indiana has not statutorily established an advanced practice nurse label akin to most states, the scope of the nurse anesthetist practice in indi­ ana is still collaborati,ve due to the supervision requirement. although any type of physician may collaborate with nurse anesthe­ tists while the nurse sedates patients, much of the time crnas and anesthe­ siologists work closely together in operating rooms to administer anesthesia.47 the american society of anesthesiologists (asa) ''believes that nurse anesthetists are qualified to perform some, but not all, of these services [that an anesthesiologist can perform], and onr under the supervi­ sion of a physician, preferably an anesthesiologist.'.4 this sentiment is often rooted in the differing educational and training requirements of the two disciplines, with anesthesiologists believing their profession is prepared to make sudden medical judgments that nurse anesthetists never learn in their curriculum.49 .while a nurse anesthetist must gain a master's degree that usually takes two to three years (in addition to four years of nursing undergraduate work), anesthesiologists must complete twelve years of formal schooling, including:50 · . four years of science-intensive pre-medical under­ graduate education; four years of medical school in which the individual gains knowledge of the funda­ mental science ofthe human condition (biochemistry, biophysics,· anatomy, pharmacology, physiology, and pathology) and receives extensive clinical instruction and experience in medical diagnosis and therapy; and four years of residency training that includes one year 44. 848 ind. admin. code 4-2-l (2011); 848 ind. admin. code 3-3-1 (2011); 848 ind. admin. code4-l-5 (2011). 45; interview with barry glazer, anesthesiologist, st. francis hospital & health centers, in indianapolis, ind. (jan. 28, 2011). 46. ind. code§ 25-23-1-30 (2011). 47. personal business, supra note 5; see rti international, supra note 17. 48. am. soc'y anestiiesiolooists, the scope of practice of nurse anesthetists 1 (2004), available at http://www.asahq.org/for-members/advocacy/-/media/ for%20members/advocacy/office%20ofyo20govemmento/o20and%20legal%20affairsl nurseanesscope.ashx. 49. seeid. 50. see am. ass'n nurse anesthetists, supra note 32; am. soc'v anestiiesiolooists, supra note 48, at 2. 2012) physician supervision of certifffid nurse anesthetists of clinical medicine, two years of clinical anesthesiol. ogy and one year of concentrated study and experi­ ence in connection with the most serious complications. 51 289 it is clear that educational requirements for anesthesiologists and nurse anesthetists differ, which is one reason why the "asa opposes the inde­ pendent practice of nurse anesthetists and views legislation and regulations designed to grant independent practice authority . . . as efforts to confer a medical degree by political means rather than by educational means.',s2 regardless of the asa's contradicting view on nurse anesthetists' inde­ pendence, state governors are given the authority to "confer" more power to nurse anesthetists, despite educational differences, based on the november 2001 cms rule. 53 c. reimbursement ofckna service government programs, along with public and private health· plans4 provide reimbursement to crnas for performing anesthesia to patients.5 medicare, a health plan for senior citizens and individuals with certain disa­ bilities, is the largest program for reimbursement directly to crnas.55 medicare uses a formula to determine reimbursement amounts: the sum of base units (which describe the complexity of the anesthesia procedure) and time units (where fifteen minutes equals one unit) multiplied by a conver­ sion factor (in dollars).56 in addition to crna reimbursement, anesthesiol­ ogists can be paid under medicare for directin' administration of anesthesia, but only when certain conditions are met. 5 under the tax eq­ uity and fiscal responsibility act of 1982 (tefra), an anesthesiologist must carry out the following conditions in each case in order to be reimbursed under a claim for directing anesthesia:58 . 1) performance of a pre-anesthetic examination and evaluation; 59 2) preparation of an anesthesia plan;60 51. am. soc'y anesthesiologists, supra note 48, at 2. 52. /d. at7. 53. see american association ofnurse anesthetists, supra note 21; hospital condi­ tions of participation: anesthesia services, 66 fed. reg. 56,762, 56,763 (nov. 13, 2001) (to be codified at 42 c.f.r. pts. 416,482, 485) (citing the governor's ability to exercise the ex­ emption so physician supervision is not required). 54. am. ass'nnursbanesthetists, supra note 23 (citing reimbursement ofcrna services section ofthe compilation). 55. id (citing reimbursement ofcrna services section of the compilation). 56. id (citing reimbursement ofcrna services section of the compilation). 57. /d (citing reimbursement ofcrna services section of the compilation). 58. am. soc'y anesthesiologists, supranote48, at9-10. 59. id at9. 60. /d. 290 indiana health law review [vol. 9:1 3) personal participation in the most demanding parts in the anesthesia 1 . 1 . du . d 61 p an, most important y m ction an emergence; 4) assurance that a qualified anesthetist performed any part of the an­ esthesia plan not performed by himself or herself;62 5) frequent monitoring of anesthesia administration; 63 6) physical presence in case of emergency or need for immediate di­ agnosis;64 and 7) provide post-anesthesia care. 65 combining the reimbmsement of nurse anesthetists and the conditions for anesthesiologist payment, medicare part b reimburses in different ways.66 for "non-medically directed crna services," when an anesthesi­ ologist is not involved enough in a case to justify payment for medical di­ rection, crnas are reimbursed one hundred percent of the medicare fees according to the formula outlined above.67 when a physician fulfills the seven conditions under tefra, these so-called "medically directed crna services" are reimbursed according to the same medicare formula, with fif­ ty percent of the fee going to the directing anesthesiologist and the remain­ ing fifty percent going to the crna. 68 when an anesthesiologist oversees multiple anesthesia cases, or ''medically supervised crna services," med­ icare reimburses fifty percent of the fee to the crna and two or three base units to the anesthesiologist 69 if medically supervising, an anesthesiologist may be reimbursed for up to five simultaneous crna cases, as long as the seven tefra conditions are met. 70 ill. analysis of recent nurse anestiietist studies a. anesthesiologist direction and patient outcome the first important study of anesthesiology that is relevant to the com­ parison between anesthesiologists and nurse anesthetists was performed in 2000.71 the study compared outcomes of medicare surgery patients whose anesthesia was performed, or medically directed, by an ·anesthesiologist to 61. !d. at 10. 62. id 63. id 64. id 65. id at9-10. 66. tax equity and fiscal responsibility act of 1982, pub. l. no. 97-248, 96 stat. 324. 67. am. ass'nnurse anesthetists, supra note 23 (citing reimbursement ofcrna services section of the compilation). 68. id (citing reimbursement ofcrna services section of the compilation). 69. id (citing reimbursement ofcrna services section of the compilation). 70. !d. (citing reimbursement of crna services section of the compilation). 71. jeffi'ey h. silber et al., anesthesiologist direction and patient outcomes, 93 anesthesiology 152, 152 (2000). 2012] physician supervision of certified nurse anesthetists 291 outcomes that were not.72 the study sought to determine if elderly patients' general and orthopedic surgical outcomes differed based on anesthesiologist involvement in anesthesia delivery. 73 as mentioned above, when discuss­ ing reimbursement basics, in order to be directed, physicians or anesthesi­ ologists must fulfill the seven criteria that allow them to bill under medicare part b?4 the study included 194 430 directed and 23,010 undi­ rected cases in 245 pennsylvania hospitals?~ the patient data studied was categorized into outcomes, which included death rate within thirty days of hospital admission, in-hospital complication rate (applying forty-one events defined by international classification of diseases), and the rate of death after complications (failure-to-rescue rate).76 in order to account for possi­ ble differences in hospital administration tactics and patient individuality, the study was adjusted using a list of eleven hospital and patient character­ istics that standardized results. 77 after analysis, the study found "higher mortality and failure-to-rescue rates for patients who underwent operations without medical direction by an anesthesiologist."78 as shown below, percentages of death, complication, and failure-to-rescue were all higher in the study's undirected cases?9 the unadjusted results, based just on patient outcomes alone, were as follows. 80 importantly, medical direction did not explain adjusted complication rates in medicare patients because these rates are inade<iuate gauges of quality of care due to inaccurate coding and billing records. 1 nonetheless, after adjustment for patient and hospital characteristics, the odds ratios (the likelihood of an outcome occurring in the undirected group as opposed to the directed group) for death and failure-to-rescue were greater than 1, at 1.08 and 1.10 respectively. 82 the death and failure-to-rescue odds ratios correspond to 2.5 excess deaths per 1,000 patients and 6.9 excess failure-to72. id 73. id. at 153. 74. id 75. id. 76. /d. at 154. 77. id at 155; see also am. soc'y .anesthesiologists, supra note 48, at 32-33. 78. silber et al., supra note 71, at 160. 79. id. at 157. 80. /d. 81. id. at 160. 82. id. at 158; see also am. soc'y anestiiesiologists, supra note 48, at 32-33. 292 indiana health law revmw [vol. 9:1 rescue deaths after complications per 1,000 patients when an anesthesiolo­ gist did not perform or direct the care. 83 · the results of this study may be easily skewed by hospital differences {for example, the number of beds over 200, the hospital's nurse-to-bed ra­ tio, or the percentage of anesthesiology staff that is board certified) or from basing conclusions on elderly medicare patients; however, even after ad­ justing for both of these factors, the effect of an anesthesiologist providing care was still shown to benefit patients. 84 in concluding that mortality rates prior to and after complications were lower when anesthesiologists provid­ ed anesthesia, this study acknowledged a limitation of basing the findings on claims data and an inability to rule out the possibility conclusions could be based on differences in guality of direction, the lack of direction itself, or a combination of the two. 85 . b. cost e.ffoctiveness analysis of anesthesia providers conversely, in a more recent 2010 study, the lewin group analyzed anesthesia administration models in order to determine if different anesthe­ sia delivery models affect quality and cost-effectiveness of anesthesia ser­ vices.86 the study used "independent" crnas to refer to nurses who provide anesthesia but are not medically directed or supervised. 87 as in other studies and costing models, the terms "medically directed" or "super­ vised" were used to define crnas who provide anesthesia under anesthe­ siologist oversight. 88 the first issue considered in this study was quality of care, which is an important aspect of using alternative anesthesia delivery models.89 the authors of this study cite multiple reports that ''have found no sig­ nificant differences in rates of anesthesia complications or mortality be­ tween crnas and anesthesiologists or among delivery models for anesthesia that involve crnas, anesthesiologists, or both after controlling for other pertinent factors."90 however, impreciseness, the inability to dis­ tinguish between whether crnas or medical residents were being directed, and utilizing typical hospital practices instead of providers' specific practic83. silber et al., supra note 71, at 158. 84. id at 152. 85. id 86. press release, american association of nurse anesthetist, study shows crna­ only anesthesia delivery most cost effective (june 21, 2010), available at http:// www.aana.com/news.aspx?id=26336&terms=lewin+study. 87. paul f. hogan et al., cost effectiveness analysis of anesthesia providers, 28 nursingecon.159, 160(2010). 88. id. 89. id. 90. id 2012] physician supervision of certified nurse anesthetists 293 es are all mentioned as limitations of the past-cited $tudies.91 then, the au­ thors conclude that it is "not surprising there are no studies that show a sig­ nificant difference between crnas and anesthesiologists in patient outcomes. "92 although. the authors identified multiple flaws in such stud­ ies, and the aforementioned silber study found differences in outcomes based on supervision, the authors quickly concluded that there is no differ­ ence in quality of care between anesthesiologists and nurse anesthetists and thus sweepingly generalized a point of utmost concern to the ongoing battle between these two relevant professions. in addition to literary data, the ingenix national database that con­ tained integrated medical and financial claims data from commercial payers in 2008 was studied by the lewin group.93 out of 52,636 anesthesia claims that were reviewed, no complications arising from anesthesia were found.94 on top oflngenix, the healthcare cost and utilization project na­ tionwide inpatient sample, which compiled information from about eight million u.s. community hospital stays, was also observed.95 even though anesthesia provider information was not included in the hospital stay data, this study based its quality of care conclusion on the fact that the complica­ tion percentage for the representative sample was 0.12%.96 if quality of care is assumed to be equal regardless of who administers anesthesia, as the authors of this study portray to their readers, then the best anesthesia delive~ method for patients and facilities alike is the one that minimizes costs.9 in order to estimate costs and revenues under the differ­ ent delivery models, a model was developed to simulate costs for each type of delivery. 98 the user of the model must specify a number of key factors, such as: demand (number of patients seeking an operation in a day), char­ acteristics of the anesthesia procedure (a base unit complexity number and the time required to do the procedure), and a payer distribution (noting the type of payment for each patient).99 further, the cost estimation model used the salary or annual earnings of anesthesiologists and crnas to de­ termine the final values.100 results of the simulation when patient flow was sufficient to have four anesthesia procedures per day were as follows.101 91. id. 92. id. at 161. 93. id. 94. id. 95. id. 96. id. 97. id. 98. id. at 162. 99. id. 100. id. 101. id. at 163. 294 indiana health law review [vol. 9:1 results of the simulation when patient flow was only two anesthesia procedures per day, when four were possible, were as follows.102 this data showed the most cost-effective delivery model was crnas practicing alone, regardless of what level of demand is present.103 when demand was below average, which would include many rural areas of the united states, all delivery modes except crnas alone would require sub­ sidies to be a viable option.104 overall, this study hypothesized that crnas · are less costly to train, provide higher revenues, and are inter­ changeable with anesthesiologists, as thecfs can perform the same anesthesia services as medical doctors for less pay.1 s after this bold conclusion regarding the cost effectiveness of nurse anesthetists was released, the american society of anesthesiologists was quick to respond.106 dr. alexander hannenberg, president of the american society of anesthesiologist (asa), offered seven reasons to question the cost-effectiveness study, including:107 1) the scope of service given by an anesthesiologist and a crna is 102. /d. at 164. 103. /d. at 165. 104. id 105. id at 168. 106. rob kurtz. asa president offers 7 reasons to question anesthesia cost­ containment study, becker's asc review (july 1, 2010}, http://www.beckersasc.com/ anesthesia/asa-president-offers-7-reasons-to-question-anesthesia-cost-containment­ study.html. 107. /d 2012] physician supervision of certified nurse anesthetists 295 not the same because an anesthesiolog!st provides critical care medicine, pain management, and on-call coverage.108 2) the comparison of outcomes is invalid because the types of proce­ dures done "solo" by crnas are of lower complexity, since patients, sur­ geons, and facilities prefer physician care for the more serious procedures.109 3) only a few states are exempt from federal standards that make it necessary for a surgeon performing a procedure to supervise crnas; thus, defining crna services as "solo" is a misnomery0 4) medicare fees for using crnas and anesthesiologists are equal, so overall costs may increase if the crna calls for medical assistance or con­ sultations. 111 5) the wage estimations for crnas and anesthesiologists that are used assume equal work hours. not only do the two professions not work the same hours, but also if crnas surpass the forty-hour week:, employ­ ment costs are considerably increased, which is not the case with anesthesiologists! 12 . 6) the center for disease control concluded in 1980 that a compara­ tive outcomes study could not be done based on ,the infrequency of major adverse anesthesia events. as thirty years have passed with fewer adverse events, the study is substantially less accurate. also, the ingenix database that was used is ''fraudulent, discredited and outlawed."113 7) in 2001, a study showed that seventy percent of all respondents would oppose a crna without supervision if a medical doctor could su­ pervise the procedure at no additional cost; thus, patients tend to prefer antb . 1 . dmin' . th . 114 es esto ogtsts a tstenng anes esta. . dr. hannenberg closed by saying, 108. id 109. id 110. id 111. id 112. id. 113. id 114. id we [anesthesiologists] stand for access to safe and leading care for patients. we've gone through years and years of rigorous training in medical school, in­ ternships, residencies and fellowships. anesthesiolo­ gists provide critical knowledge and expertise needed to keep total watch over the human body, to keep people stable and intervene when they are not. we are the leaders of anesthesia care teams which include crnas. the role of the anesthesiologist is to keep 296 indiana health law review watch over a patient's vital health when he/she is at his/her most wlnerable. we take pride in this role each and every day.115 [vol. 9:1 c. no harm found when nurse anesthetists work without supervision by physicians in a 2010 article, researchers at the research triangle institute, an in­ dependent, non-profit research institute, explored the change in the cms supervision requirement by analyzing medicare data for 1999-2005 in order to determine if the 2001 cms policy had a negative impact on patient out­ comes.116 to show an effect on outcomes, the opt-out policy must actually change the way anesthesia is being provided and there has to be a difference in the outcomes linked to the new arrangement. 117 the study identified three arrangements for anesthesia being administered: anesthesiologists practicing solo, certified registered nurse anesthetists practicing solo, and team anesthesia where nurses were directed or supervised. 118 studied data resulted in 741,518 surgical discharges, but only two­ thirds possessed anesthesia claims. the 481,440 hospitalizations that re­ mained for anaiifsis included 412,696 in non-opt-out states and 68,744 in opt-out states.11 similar to the first study discussed in this note, inpatient mortality, measured by checking discharge abstracts, and complications, detected by identifyj.n~ seven possible problem indicators, were the two measured outcomes.12 to adjust for hospitals referring more difficult pro­ cedures to anesthesiologists, the statistics were controlled to deal with pa­ tient characteristics and procedure complexity.121 resulting data showed that solo practicing nurse anesthetists did in­ crease in opt-out states, 122 which is exactly what the cms rule allows after 2001; thus, the first conclusion of the study is not shockin9.' next, the study presented results as follows of surgical inpatient mortality. 23 115. /d. 116. dulisse & cromwell. supra note 17, at 1470. 117. /d. 118. id 119. /d. at 1471; see also rti international, supra note 17. 120. dulisse & cromwell, supra note 17, at 1471. 121. /d. at 1471. 122. /d. at 1472. 123. /d. at 1473. 2012] physician supervision of certified nurse anesthetists 297 "in non-opt-out states, mortality rates for the [two] anesthesia ar­ rangements followed a general downward trend throughout the seven-year period."124 however, of interest is the "general downward trend" in opt-out states. after increasing from 1999 to 2001, the rate decreased from 2001 to 2005.125 nevertheless, the rate did not significantly decrease between 2001 and 2005; rather, it increased almost a quarter from 2002 to 2003 (one year after cms opt-out inception) and increased again from 2004 to 2005.126 further, the study failed to note that the mortality rate was lower for solo mda administration in three of five years after the supervision requirement was implemented; thus, allowing physicians to practice alone without crnas seems to be a safer alternative, regardless of the "decreasing trend" of crna solo practitioners.127 as stated earlier, linking the amended cms rule to patient outcome changes ''requires both that the proportion of surgical procedures for which certified registered nurse anesthetists alone provided anesthesia changed as a consequence of the policy change, and that the type of anesthesia provider affects the likelihood of in-hospital mortality or other adverse event."128 the data demonstrated neither of the two necessities. instead, the data found that the proportion of anesthesia without anesthesiologist supervision increased five percentage points in all states, not just opt-out states.129 nonetheless, declining mortality (or at least a downward trend according to the study) was normal despite the increasing number of solo nurse anesthe­ tists in opt-out states. this mortality rate was even lower than solo anesthe­ siologists' mortality rate.130 these results led researchers to recommend that "cms return to its original intention of allowing nurse anesthetists to work independently of surgeon or anesthesiologist supervision without re124. !d. 125. !d. 126. !d. 127. !d. 128. !d. 129. !d. 130. id 298 indiana health law review [vol. 9:1 quiring state governments to formally petition for an exemption."131 thus, the researchers here advocate adopting the aforementioned clinton nurse autonomy rule that was a response to the 1997 "original" intention of the h lth c f. . adrnini' . 132 ea are mancmg stratton. like the cost-effectiveness study, the asa did not allow this article to be published without comment.133 the asa believes the aana-sponsored paper "is an advocacy manifesto masquerading a.~ science and does a dis­ service to the public. it makes dangerous public policy recommendations on the basis of inadequate data, flawed analysis and distorted facts. "134 the inadequate data stems from the fact that billing data was used to make forthri~t conclusions about doing away with supervision of nurse anesthe­ tists.13 such data does not distinguish between complications that happen during surgical procedures or due to anesthesia.136 further, conditions are not noted as existing prior to surgery or as a result of anesthesia or surgery; thus, utilizing such data for a momentous hypothesis is flawed. 137 in addition, if using the institute ofmedicine's current death per anes­ thesia mortality estimate based on 481,000 cases, the study would have dis­ covered two anesthesia-related deathsk which is an unrealistic number on which to base mortality hypotheses.13 lastly, asa member and former nurse anesthetist, ann c. still, m.d., averred, "having cared for patients as a crna and now as an anesthesiologist, i see daily how safe patient care requires a physician's training."139 iv. opt-out state requirements, statutes, and regulations versus current similar indiana law as of october 2010, sixteen states have opted out of the federal super­ vision requirement since the enactment of the november 13, 2001, cms rule. 140 of particular importance in this note are new jersey, california, and colorado because these states' nurse anesthetist regulations or opt-out decisions have been legally challenged. scrutinizing the claims against each state in these cases will allow for a better prediction regarding the con­ sistency or inconsistency of a possible opt out in indiana as compared to 131. id at 1475. 132. see generally id 133. press release, american society of anesthesiologists, asa statement regarding aana-sponsored paper published in health affairs, august 2010 (aug. 5, 201 0), available athttp://www.asahq.org/news/asanews080510.htm. 134. /d. 135. /d. 136. id 137. /d 138. /d. 139. /d. 140. am.ass'nnurse.anesnmnsts,supranote 15. 2012] physician supervision of certified nurse a.nestiietists 299 nurse anesthetist regulations currently in place in opt-out states. further, a more unproven analytic comparison of indiana and the opt-out states of io­ wa, washington and wisconsin based on geographic and demographic data bolsters the argument that indiana is not similarly situated to necessitate opting out. a. opt-out requirements in order to opt out of the federal supervision requirement, the state's governor must send a confirmation letter to cms stating that he or she has consulted with the state's boards of medicine and nursing regarding issues related to patient access and quality of care of anesthesia, opting out is in the best interest of the state citizens, and the opt-out is consistent with state law.141 upon the governor's submission of the attestation letter, the opt-out bee . d' l £'c, • 142 omes tmme tate y eu.ective. in response to comments about the opt-out rule, cms made clear that consultation between governors and state boards of medicine and nursing is required in order to jnclude both sides in the opt-out discussion; however, "consultation" was purposefully not explicitly defined so that governors have maximum flexibility when making the opt-out decision.143 the fact that decisive authority remained in the hands of governors, who may not be scientifically endowed to review literature and make decisions, worried many commentators.144 cms countered by pointing out that most scope­ of-practice regulations for practitioners are made by states, thus enacting the opt-out rule to eliminate such regulations is no different.145 another gray area is the interpretation of the "consistency with state laws" requirement, which produced the most comments when the opt-out rule was proposed. this ~rement dealt with requests to outline steps in determining "consistency."1 cms recognized the differing opinions be­ tween anesthesiologists and nurse anesthetists on the state law issue (anes­ thesiologists say that only new hampshire allows crnas to practice without supervision, while nurse anesthetists, based solely on nursing regu141. medicare and medicaid programs; hospital conditions of participation: anesthe­ sia services, 66 fed. reg. 56,762, 56,763 (nov. 13, 2001) (to be codified at 42 c.p.r. pts. 416, 482, 485). 142. am.ass'nnurseanesthetists,supranote 15. 143. medicare and medicaid programs; hospital conditions of participation: anesthe­ sia services, 66 fed. reg. 56,762,56,763-64 (nov. 13, 2001) (to be codified at 42 c.p.r. pts. 416,482, 485). 144. medicare and medicaid programs; hospital conditions ofparticipation: anesthe­ sia services, 66 fed. reg. 56,762, 56,766 (nov. 13, 2001) (to be codified at 42 c.p.r. pts. 416, 482, 485). 145. medicare and medicaid programs; hospital conditions of participation: anesthe­ sia services, 66 fed. reg. 56,762, 56,766 (nov. 13, 2001) (to be codified at 42 c.p.r. pts. 416,482, 485). 146. id. 300 indiana health law review [vol. 9:1 lations, argue that thirty-nine states do not have supervision requirements for crnas) but believed governors were the best suited to determine if opt­ ing out was consistent with state law!47 the bottom line is that ''the gover­ nor's letter to the administrator of cms will be accepted on face value, with no indefendent cms scrutiny or analysis of the governors' underlying rationale. "14 b. challenged state regulations or opt-out decisions 1. state law challenges a. new jersey office-setting nurse anesthetist supervision although new jersey is not an opt-out state, nurse anesthetist supervi­ sion requirements have been challenged both in the apeellate division of the superior court and the new jersey supreme court. 49 in 1997, ironi­ cally, the same year that the health care financi~ administration pro­ posed the nurse autonomy rule to president clinton, 1 the new jersey state board of medical examiners moved in the opposite direction by proposing, and later codifying/ supervision regulations for anesthesia administered in a physician's office. 51 when either general or regional anesthesia is admin­ istered by a crna in a new jersey doctor's office, the crna must be ''under the supervision" of a ''physician privileged by a hospital or the board" to give anesthesia.152 in addition, the monitoring physician must ''be physically present and available to immediately diagnose and treat the patient in an emergency, without concurrent responsibilities to administer anesthesia or perform surgery, other than minor surgery."153 once this regulation was adopted, the new jersey association of nurse anesthetists (njana) brought an appeal challenging the adoption, stating that it was without medical support, an arbitrary promulgation, and 147. medicare and medicaid programs; hospital conditions of participation: anesthe­ sia services, 66 fed. reg. 56,762,56,764-65 (nov. 13, 2001)(to be codified at 42 c.f.r. pts. 416, 482, 485). 148. medicare and medicaid programs; hospital conditions of participation: anesthe­ sia services, 66 fed. reg. 56,762, 56,766 (nov. 13, 2001) (to be codified at 42 c.f.r. pts. 416, 482, 485). 149. linda dycbkowsk:i, it's still "no!" for n.j. crnas, nurse.com (mar. 27, 2006), http://news.nurse.com/apps/pbcs.dlllarticle?aid=2006603270382. 150. goldstein, supra note 7. 151. n.j. state ass'n of nurse anesthetists v. n.j. state bd. of med. exam'rs, 859 a.2d 1239, 1240 (n.j. super. ct. app. div. 2004), affd sub nom. n.j. ass'n of nurse anes­ thetists v. new jersey state bd. ofmed. exam'rs, 875 a.2d 247 (n.j. 2005). 152. n.j. admin code§§ 13:35-4a.9(ax1), (b)(2011). 153. n.j. admin code § 13:35-4a.9(c) (2011); see also n.j. state ass'n of nurse anesthetists, 859 a.2d at 1241-42. 2012] physician supervision of certified nurse anesthetists 301 . f th . gul th . . 154 h an overextension o au onty to re ate e nursmg practice. owever, the medical board "specifically may adopt rules to protect the health, safety and welfare of its licensees' ~tients and provide standards for the practice of medicine in new jersey." 55 regardless, the njana argued that stud­ ies, similar to those mentioned previously, demonstrate that death rates are the same among patients obtaining care from anesthesiologists as they are among those receiving care from nurse anesthetists working alone, making the supervision arbitrary.156 the appellate division of the superior court found persuasive the medical board's position that these studies deal with hospitals, where an anesthesiologist is usually present, instead of the rele­ vant office setting where no such studies have been conducted.157 moreover, the njana claimed that no factual basis existed for im­ plementing this regulation; however, the court discarded this argument based on a belief that the board "should not have to wait for bad results to require that its physicians meet higher standards in the administration of patient care."158 lastly, the njana argued that the board was regulating the nursing profession, which the court concluded was incorrect, as only physicians who offered anesthesia in their offices were being regulated to ensure certain credential requirements were being met.159 thus, the adop­ tion of regulations by the new jersey state board of medical examiners was ultimately found to be lawful, and the crnas were required to adhere to supervision.160 when the njana appealed the decision of the appellate division, the supreme court of new jersey~ concluding that the education and training of anesthesiologists better prejares them to ''protect patients and to respond when complications occur!'1 the court also found that there was insufficient evidence relative to available research to find that safety levels between doctors and crnas sedating patients are equal.162 b. louisiana scope of practice ruling another non-opt-out state where crna activity has produced litiga­ tion is louisiana. in 2005, the louisiana state board of nursing (lsbn) implemented a policy permitting crnas to perform pain management, 154. n.j. state ass'n of nurse anesthetists, 859 a.2d at 1241-42; dychk:owski, supra note 149. 155. in re n.j.a.c. 13:35-6.14, 501 a.2d 547, 550 (n.j. super. clapp. div. 1985). 156. n.j. state ass'n ofnurse anesthetists, 859 a.2d at 1244. 157. /d. 158. /d. 159. /d. at 1245-46. 160. see id. at 1246. 161. n.j. ass'n of nurse anesthetists v. n.j. state bd. of med. exam'rs, 875 a.2d 247, 251 (n.j. 2005). 162. jd at 250. 302 stating: 163 indiana health law review [i]t is within the scope of practice for the crna to perform procedures under the direction and supervi­ sion of the physician· involving the injection of local anesthetics, steroids and analgesics for pain manage­ ment purposes, peripheral nerve blocks, epidural in­ jections, and spinal facet joint injections when the crna can document education, training and experi­ . ence in performing such procedures and has the knowledge, skills, and abilities to safely perform the procedures based on an order from the physician.164 [vol. 9:1 consequently, an anesthesiologist pain management group, spine di­ agnostics center of baton rouge, filed suit seeking an injunction against the lsbn to enjoin the adoption of such a provision and prevent crnas from practicing pain management.165 statutorily, crnas in louisiana cannot perform anesthesia unless the anesthetics and ancillary services are administered ''under the direction and supervision of a physician or dentist."166 based on this statute alone, crnas may argue that pain management is an allowable anesthetic "ancil­ lary service" they can perform under supervision. in the alternative, the crnas could contend that if prohibition of crnas performing pain man­ agement was intended by the legislature, it would have been included in the louisiana anesthesia administration statute.167 the louisiana court of appeal did not accept either of these possible crna arguments and affirmed the district court's judgment in favor of spine diagnostics center based on scope of practice reasoning.168 the ap. pellate decision concluded that ''the statement issued by the lsbn expand­ ed the scope of practice for crnas into an area where they have not traditionally practiced" and that "pain management is not within the sco~ of practice of a crna, but rather is solely the practice of medicine." 69 multiple witnesses backed the finding. 170 in particular, dr. frank falco believed that practicing pain management without proper training could 163. ga. ass'n of nurse ane81hetists, louisiana appellate court rules against crna-provided chronic pain management 2 (2009) available at http://www.gana.org/documents/ louisianaru1esagainstcrnapdf; spine diagnostics ctr. of baton rouge, inc. v. la. state bd. ofnursing, 4 so. 3d 854, 857 (la. ct. app. 2008). 164. spine diagnostics ctr. of baton rouge, inc., 4 so. 3d at 857. 165. id 166. la. rev. stat. ann.§ 37:930 (2011). 167. spine diagnostics ctr. of baton rouge, inc., 4 so. 3d at 863. 168. ga. ass'nofnurseanesthetists,supra note 163. 169. spine diagnostics ctr. of baton rouge, inc., 4 so. 3d at 867. 170. see id at 865. 2012] physician supervision of certified nurse anes1hetists 303 bring about to adverse consequences due to the varying complexity of each patient's pain management program.171 c. california opt-out challenge similar to the challenge by the nurse anesthetists in new jersey, the california society of anesthesiologists brought suit against california governor arnold schwarzenegger in february 2010 to dis_gute that his 2009 opt-out was inconsistent with state law in califomia.1 in california, crnas' scope of practice is broadly defined under the practice of nursing as: ''those functions, including basic health care, that help people cope with difficulties in daily living that are associated with their actual or potential health or illness problems."173 nurses can also administer medications and therapeutic agents, which have been universally understood to include anes­ thesia that are "ordered by and within the scope of licensure of a physi­ cian."174 nevertheless, the practice is somewhat limited because nothing defining the scope of nurse anesthetist practice in california confers the f . d' . 175 power o a nurse to practice me tcme or surgery. with only a trial court order available thus far, and appellate review beginning on january 31, 2011, the arguments by the parties to the califor­ nia ogt-out challenge have to be deduced solely from the trial court's find­ ings. 6 the california society of anesthesiologists, like other anesthesiologists outlined in this note, claimed that to be "ordered by" a physician is synonymous with being supervised.177 as a matter of fact, the asa notes that "supervision or direction" can come in the "form of a phy­ sician's patient-s~ecific order, request or prescription of treatment for anes­ thesia services." 78 thus, to order a nurse anesthetist to administer medication most assuredly would be supervision.179 however, the trial court did not accept this argument, simply dismissing it by stating ''the plain meaning of the word 'ordered' is not 'supervised. "'180 in addition, ''cali171. /d. 172. summons on complaint at 1, cal. soc'y of anesthesiologists et al. v. schwarzenegger, no. 10-510191 (cal. super. ct. s.f. cnty. feb. 24, 2010). 173. cal. bus. & prof. code§ 2725(b )(2011). 174. cal. bus. & prof. code§ 2725(b)(2) (2011). 175. cal. bus. & prof. code§ 2833.5 (2011). 176. notice of appeal at l, cal. soc'y of anesthesiologists et al. v. schwarzenegger, no. 10-510191 (cal. super. ct. s.f. cnty. jan. 31, 2011). 177. crna scope of practice under california law, on your behalf ... legislative and practice .affajrs dmsion (cal. soc'y of anesthesiologists, san mateo, cal.), fall 2007, at 30, available at http://www.csahq.org/pdf/bulletin/issue_l8/lpad_ 56_3.pdt: 178. am. soc'y anesthesiologists, supra note 48, at 34. 179. see id. 180. summary judgment order at 3, cal. soc'y of anesthesiologists et al. v. schwarzenegger, no. 10-510191 (cal. super. ct. s.f. cnty. dec. 27, 2010). 304 indiana health law review [vol. 9:1 fornia law does not contain any explicit supervision requirement. rather, at best, it is ambiguous on the supervision issue."181 an alternative argument of the society was that administering anesthesia fits into the practice of medicine; therefore, giving crnas the ability to administer anesthesia without supervision contradicts california state law prohibiting nurses from practicing medicine.182 like the anesthesiologists' supervision argu)!:!ent, the trial court did not find their alternative argument persuasive either.183 on the contrary, crnas in california quickly pointed out that in oth­ er provisions defininjj the practices of different nurse types the word "su­ pervision" appears.1 for example, when dealing with a midwife, ''the furnishing or ordering of drugs or devices by a certified nurse-midwife oc­ curs under physician and surgeon supervision. for purposes of this section, no physician and surgeon shall supervise more than four certified nurse­ midwives at one time."185 if the legislature intended to include "supervi­ sion" for the nurse-midwives, then lawmakers would have included such wording for crnas if it were required.186 based on the aforementioned arguments given by both sides, and ac­ cepting those offered by governor schwarzenegger and the california as­ sociation of nurse anesthetists .as interveners, summary judgment upholding the state opt-out was granted.187 therefore, the superior court of the state of california, county of san francisco found that governor schwarzenegger's june 10, 2009letter to cms opting out of federal crna supervision requirements was not an abuse ofhis discretion.188 d. colorado opt-out challenge. on september 28,.2010, .the colorado society of anesthesiologists brou~t suit to challenge governor bill ritter's october 2010 opt-out deci­ sion, 89 in their complaint the colorado society of anesthesiologists prayed for a declaratory judgment and injunctive relief based on controver­ sy about statutes dealing with the administration of anesthesia, making the opt-out inconsistent with state law.190 "on july 29, 2010, governor ritter 181. id. at2. 182. see id at 6; see also cal. bus. &prof. c0db § 2833.5 (2011). 183. summary judgment order at 6, cal. soc'y of anesthesiologists et al. v. schwarzenegger, no. 10-510191 (cal. super. ct. s.f. cnty. dec. 27, 2010). 184. seeid at3. 185. cal. bus. & prof. codb § 2746.5l(a)(4)(201l). 186. summary judgment order at 3, cal. soc'y of anesthesiologists et al. v. schwatzenegger, no. 10-510191 (cal super. ct. s.f. cnty. dec. 27, 2010). 187, id. at 7. 188. id. at i. 189. hot issues, colo. miid. soc'y, hup:/lwww.cms.orglpublic-affairs/hot-issues/ #anesthesiao/o200pto/o200ut (last visited jan. 8, 2012). 190.. o:mlplaint at 2, colo. med. soc'y v. ritter, no. 33504523 (denver dist. ct. sept. 28, 2010). 2012] physician supervision of certified nurse anesthetists 305 issued a letter to the colorado medical board and the colorado board of nursing which declared his 'understanding' that 'the colorado nurse prac­ tice act allows crnas to practice without direct supervision from a physi­ cian. "'191 according to an eight to five vote of the colorado medical board, it was later determined that an opt-out was consistent with state law, sparkin2 firm disagreement from the colorado society of anesthesiolo. ts 19t gts . in colorado, nurse anesthetists are classified as advanced practice nurses, meaning that the nurse bas specialized training and bas applied to the board to be included in the advanced practice registry.193 the scope of practice comes under the definition of a delegated medical function, which means "an aspect of care that implements and is consistent with the medical plan as prescribed by a licensed or otherwise legally authorized physician .. . and is delegated to a registered professional nurse by a physician."194 for the purpose of defining delegated medical function, ''medical plan" includes any written plan, verbal order, or standing order that authorizes specific ac­ tion!95 using these statutory provisions, the colorado society of anesthesiol­ o~sts brought many of the same arguments as those in the california socie­ ty.196 for one, the colorado anesthesiologists believe that delegated medical functions by nurse anesthetists must follow accepted ·practices; therefore, since administration of anesthesia is practicin' medicine, supervi­ sion is required under accepted practices in colorado.1 7 on the contrary, governor ritter and the nurse anesthetist association would likely make the same argument that was accepted in california: that supervision and an "order'' are not synonymous terms. thus, if a medical plan includes the nurse who administers the anesthesia, colorado law would not explicitly require supervision of anesthetists. as with california, the language of the colorado statute does not seem strong enough to overturn the deference given to the governor in opt-out decisions, but continuing to monitor this case as it moves through the colorado court system is necessary. e. the indiana code language and precedent cases as mentioned earlier, a crna in indiana can only perform anesthesia "if the certified registered nurse anesthetist acts under the direction of and 191. id at3. 192. id. 193. cow. rev. stat.§ 12-38-111.5(2)(2010). 194. cow. rev. stat.§ 12-38-103(4) (2010). 195. id 196. see complaint at 4-6, colo. med. soc 'y v. ritter, no. 33504523 (denver dist. ct. sept. 28, 2010). 197. cow. rev. stat.§ 12-38-103(10xa) (2010). 306 indiana health law review [vol. 9:1 in the immediate presence of a physician."198 based on the foregoing chal­ lenges and the language of the indiana code, the indiana society of anes­ thesiologists would have a much better argument that an opt-out is inconsistent with indiana state law. both california and colorado use the word "order" when defining how a physician monitors a nurse anesthe­ tist.199 indiana's language is much stronger, as its code requires nurses 1o be both under the direction and in the presence of a physician. it would be hard for the governor to claim, as in california and colorado, that direct supervision of crnas is not explicitly defined by statute in indiana. in addition, indiana could use the new jersey persuasive authority, even though it deals with office procedures, to bolster the argument that lawmak­ ers have a factual basis to regulate crna scope of practice. by pointing to the weaknesses of the cost-effectiveness and medicare data studies dis­ cussed earlier in this note, indiana anesthesiologists would also be able to show that, effectively, nurse anesthetists have not come up with an empiri­ cal study proving their practice is as safe or safer than anesthesiologists administering anesthesia because input data is flawed. 200 in addition, indiana has the ability to draw from the ruling by the lou­ isiana appellate division decision regarding scope of practice. although the cms opt-out provision does not expand crnas scope of practice re­ sponsibilities, the perspective given by dr. falco (finding crnas under qualified to perform chronic, complex pain management) bolsters the argu­ ment that indiana should not opt out of supervision.2°1 since crnas are not able to provide the pain management that anesthesiologists regularly administer, it is logically concluded that the aforementioned knowledge disparity between anesthesiologists and crnas is wide. extending the gap to current crnas' scope of practice abilities shows that complications stemming from crnas' inability to assess "medical" situations are a com­ pelling reason to not eliminate supervision requirements. c. similarly situated opt-out states contrasted to indiana 1. rural setting and hospital analysis based on similar population and agriculture data in each state, iowa, 198. ind. code§ 25-23-1-30 (2010). 199. see cow. rev. stat. § 12-38-103(4) (2010); cal. bus. & prof. code § 2725(b)(2) (2011). 200. see press release, american society of anesthesiologists, asa statement re­ garding aana-sponsored paper published in health affairs. august 2010 (aug. 5, 2010), available at http://www.asahq.org/for-the-public-and-media/press-room/news-archives/ asa-statement-regarding-aana-sponsored-paper-published-in-health-affairs.aspx; kurtz, supra note 106. 201. see spine diagnostics ctr. of baton rouge, inc. v. la. state bd. ofnursing, 4 so. 3d 854, 865 (la. ct. app. 2008). . 2012] physician supervision of certified nurse anesthetists 307 washington, and wisconsin will adequately demonstrate the differences between three similarly situated, opt-out states as compared to indiana. the population and farm acreage by state are as follows. aside from population and farmland, total land area of each of the four states is also of interest. indiana is the smallest state in square miles of any ofthe four at 36,417 (compared to 56,273, 71,298, and 65,496 for io­ wa, washington, and wisconsin respectively).204 lastly, and likely most importantly, indiana has the most non-federal, short term, acute care hospi­ tals of any of the four mentioned states with 100 (co~ared to 40, 61, and 75 for iowa, washington, and wisconsin respectively). 5 this data shows indiana as the second most agricultural, the second most populated, the smallest in terms of square mileage, and the densest in terms of hospitals when compared to similarly situated states of iowa, washington, and wisconsin. a logical conclusion from these findings is that rural patient access is not as limited in indiana as the other states be­ cause patients travel shorter distances to get to hospitals based on the pre­ sumption that there is a link between low square mileage and high number of hospitals in indiana. stemming from this analysis, an argument rejecting an indiana opt-out is reasonable, as doctors are more readily available and in closer proximity to possible facilities that would need a physician to su­ pervise crnas upon short notice. overall, looking solely at rural area and hospital data, arguments against indiana's patient access to anesthesia would crumble when compared to similarly situated opt-out states like io­ wa, washington, and wisconsin, making an indiana opt-out decision one the governor of indiana need not contemplate due to anesthesia availability and patient access. 2. statutory or code regulation comparison of similarly situated states in addition to a geographic and demographic analysis among the four 202. u.s. census bureau, statistical abs1ract of the united states: 2010, 21 tbl.l2 (201 0), available at http:/ lwww .census.gov/prod/2009pubs/1 ostatablpop.pdf. 203. /d. at 805 tbl.801. 204. id. at 221 tbl.355. 205. hospital statistics by state, american hospitals directory, http://www.ahd. com/state_statistics.html (last updated apr. 18, 2011). 308 indiana health law review [vol. 9:1 "states mentioned, a further look into statutory comparison will also be valu­ able in assessing why indiana should not opt out of nurse anesthetist super­ vision. in indiana, "[a] certified registered nurse anesthetist may administer anesthesia if the certified registered nurse anesthetist acts under the direc­ tion of and in the immediate presence of a physician.'.206 on the contrary, iowa hospital regulation 'only requires at a minimum that, "anesthesia ser­ vices [are] provided under the direction of a qualified doctor of medicine or osteopathy.''207 like iowa, washington orders hospitals to adopt policies that "[ d]efine the staff qualifications and oversight for administering each type of anesthesia in the hospital.'.2°8 so, it is clear that some oversight is necessary in iowa and washington. however, to reiterate, indiana is the only state that requires the "immediate presence" of a physician.209 iowa's and washington's "direction" and "oversight" regulations are more lenient and could be construed as only requiring a physician to know a nurse anesthetist is independently administerin~ anesthesia, so that in case of emergency they would be privy to the case. 10 as a result, it is likely that anesthesiologists in both iowa and washingto14like california, would not be able to prove that state law requires supervision. so, based on a geo­ graphic and demographic analysis, along with further statutory code com­ parisons, indiana has two key differences from the opt-out states of iowa, washington, and ·wisconsin before scrutinizing problems that may arise from an indiana opt-out. .v., problems arising if indiana were to opt out of physician supervision if indiana were to opt out of physician supervision, problems would .arise .stemming from certificatio14 legislatures current opinion on crnas, and the inability to challenge the opt-out. regarding certification, cms stated that the final rule is flexible, and "[r]egarding patient safety, this final rule is consistent with our efforts to improve the quality of care fur­ nished through federal programs, while at the same time recognizing states' traditional domain in establishing professional licensure and scope­ of-practice laws.'.2tt however, as stated above, indiana does not recognize certification or require any further process to ~ce as a crna after the nurse passes the national board certification test.212 such leniency in indi206. ind. code ann.§ 25-23-1-30 (lexisnexis 2010). 207. iowa admin. coder. 481-51.28 (2010). 208. wash. admin. code§ 246-320-241 (2010). 209. ind. code ann. § 25-23-1-30 (lexisnexis 201 0). 210. iowa admin. code r. 481-51.28 (2010); wash. admin. code § 246-320-241 (2010). 211. am. ass'n nurse .anesnmnsts, supra note 23 (citing the legal issues in nurse anesthesia practice section of the compilation). 212. ass'n nurse anestiie11sts, supra note 38. 2012] physician supervision of certified nurse anesthetists 309 ana may lead to less qualified crnas attempting to practice in the state, which in tum could lead to less favorable anesthesia outcomes than opt-out states that define crnas as advanced registered practice nurses and require licensing.213 with forty-eight states and the district of columbia requiring certification beyond the national exam, michigan and indiana, two states that have not opted out of federal reimbursement for crna activity, remain in the clear minority with regard to officially recognizing nurse anesthetists to practice.214 in addition to lagging behind in the certification department, indiana also does not offer an accredited nurse anesthetist educational program_215 according to aana, there are thirty-eight states, including the district of columbia, that offer a total of one hundred twelve programs.216 since indi­ ana lacks a nurse anesthesia program, quality control of in-state nurse anes­ thetists could potentially be an issue. if hospitals, critical access hospitals, and ambulatory surgery centers in indiana are counting on educators from different states to train its nurse anesthetists, there is no way to educate crnas as to certain experiences, nuances, preferences, or regulations that are unique to indiana. thus, without upholding the supervision requirement in indiana, physicians would, for all practical purposes, be allowing nurses trained by educators with differing scope of practice regulations in mind to administer anesthesia, which is not a patient friendly idea. lastly, indiana senator patricia miller carried a 2009 bill that attempt­ ed to include indiana crnas as advanced registered practice nurses; how­ ever, the bill died.217 the death of this bill, which would have expanded the function of indiana crnas, illustrates that indiana lawmakers are not ready to hand the control of anesthesia in the state over to nurses. such a feeling is consistent with a study conducted by the terrance group in 2001 which found that seventy percent of medicare beneficiaries opposed the decision to drop the old requirement of supervision and allow nurse anes­ thetists to administer anesthesia without supervision.218 . vi. soltmons and conclusion: keep the status quo regarding supervision in indiana after analyzing the available studies, data, and law, indiana should come to the conclusion that the status quo of requiring physician supervi213. am. ass'n nurse.anestiibtists, supra note 42. 214. ass'n nurse anestiibtists, supra note 38. 215. see becoming a crna: accredited programs, am. ass'n nurse a:nestiibtists, http://www.aana.com/aanaaffiliates/accreditation/pages/accredited-programs.aspx (last visited jan. 12, 2012). 216. see id. 217. s.b. 190, 116th gen. assemb., reg. sess. (ind. 2009). 218. the tarrance group, national anesthesia snjdy w: a survey of public opinion attinmes 3 (2001). . 310 indiana heal til law review [vol. 9:1 sion of certified registered nurse anesthetists should be upheld. for one, physician supervision of crnas allows for a more risk-averse, patient pre­ ferred anesthesi~ care.219 even though administration of anesthesia is about fifty times safer than it was thirty. years afo due to better technology and practice standards, death is still possible.22 measures taken to increase the likelihood of saving a human life is undeniably a reason to uphold supervi­ sion requirements. secondly, potential financial costs increase more if phy­ sician consultation is needed when a nurse anesthetist is allowed to administer unsupervised care, and something goes wrong. in the current, poor economic times, changing requirements may also increase costs. when one of the opt-out provision's cornerstone arguments is cost­ effectiveness, is not a sound decision if the state government is to be look­ ing out for the best interests of indiana citizens. nonetheless, if .the decision to opt out of physician supervision is made in indiana, the state should take action to further certify crnas apart from the national accreditation test that one must take to practice as a nurse anesthetist. however, in order to effectively certify and educate indiana nurse anesthetists, the state must invest in a nurse anesthetist edu~tion pro­ gram. only by requiring state recognition to practice and investing in an education program can indiana ensure nurse anesthetist procedures are as safe as possible when nurses are unsupervised. as presented in the introduction to this note, dr. gleimer's twenty­ eight year old arthroscopy patient is a prime example of why a medical doc­ tor needs to be present when a nurse anesthetist administers anesthesia. dr. carol bannister, a former crna and current anesthesiologist, said that many times "[she] felt very much on thin ice," as a nurse anesthetist and that it frightens her to think about being unsupervised during her time as a nurse.221 overall, dr .. gleimer said it best himself: "we've all been in the or, when a nurse anesthetist reaches the end of her ability to treat the pa­ tient .... at that point, she hollers for an anesthesiologist to get her out of deep water.'.222 indiana can avoid this "thin ice" and "deep water" if they keep the physician supervision requirement required to gain medicare re­ imbursement for crna activity, or in the alternative take preemptive measures to certify and educate future nurse anesthetists. 219. id. 220. am. ass'n nurse anesthetists, supra note 23 (citing quality of nurse anesthe­ sia practice section of the compilation). 221. rowland, supra note 6. 222. sataline, supra note 1 (internal quotation marks omitted). introduction jennifer s. bard, j.d., m.p.h.* i. background: how a panel became a symposium .•.•............ 391 ii. the panelists ..................................... : ......................................... 391 a. wendy parmet ........................................................................... 391 b. charity scott ............................................................................. 392 c. marshall kapp .......................................................................... 393 d. jonel newman .......................................................................... 394 e. sallie thieme sanford ............................................................... 395 iii. proposals ..................................................................................... 395 a. michele mekel ........................................................................... 395 b. emily berifer .................................. ............................................ 395 c. christine nero coughlin ........................................................... 396 d. dea. c. lott .............................................................................. 397 e. kathleen noonan and sarah davis ........................................... 398 the essays printed here reflect the work of ten health law professors and are important to all law professors working to integrate experiential learning in their curriculums. the essays originated from a panel presenta­ tion i designed for the section of law, medicine, and health care at the 2012 meeting of the american association of law schools. it was entitled, "health law professors engaging in the real world," and my goal as in. coming chair was to inform not just those who heard it live in washington, d.c., but to a broader readership of teachers who wanted to reach out be­ yond the classroom without taking on the daunting task of running a live­ client clinic. having myself come into academe after a career in private practice and government service followed by two years teaching at a medi­ cal school, i knew how much contact with the real world of health care and health law could benefit both students and faculty. i have written elsewhere of the lessons legal and medical education can learn from each other, but * chair of the american association of law school's section on law, medicine, and health care; alvin r. allison professor of law and associate dean for faculty research and de­ velopment; director, health law and j.d./m.d. programs at texas tech school of law; associate professor (adjunct), department of psychiatry, ttu school of medicine. thank you to all the panelists and all those who responded to the call for papers. thank you also to the executive board and members of the aals section on law, medicine and health care and especially to joan h. krause, associate dean for faculty development and dan k. moore distinguished professor of law, who was chair of the section, at the time this panel was developed. thank you also to jane la barbara, managing director of aals, and tracie thomas, senior meetings manage, whose hard work, flexibility, and ability to solve all problems, large and small, were much appreciated. finally thank you to charles blevins, texas tech university school of law '12, for his substantial help in organizing the panel. 390 indiana health law review [vol. 9:2 the primary difference between the two is that medical students benefit from an extended apprenticeship which allows them to turn the knowledge they learned in.the classroom into the skills they need for reallife.1 this is possible because medical graduate education is funded by the federal gov­ ernment.2 lacking this kind of training subsidy, we in legal education must make the best use possible of the three years we have to help students be­ come competent, compassionate and ethical lawyers. this cannot be achieved by· sitting in a lecture hall. . . although the panel was a terrific 8ucce8s,3 its lasting legacy will be the writings of these innovative health law professors. in reading their work you will be inspired, as i am, to see new possibilities for bringing into your classes the real world where health care law is not just studied, but where it is practiced. in looking for ways that health law professors are engaging with (again broadly defined) the people who face the legal issues we teach, i re­ alized that on the one hand there were many existing models and on the other that it was a project far beyond the sc<>pe of a single aals panel. i also realized that identifying the activities of a "health lawyer" were as dif­ ficult as defining "health law.',4 health lawyers practice in many different areas including mental and physical disability, family, non-profit taxation and antitrust.5 so given the impossibility of giving any kind of comprehen­ sive overview of the subject matter, i took a step back and looked for pro­ grams which could engage those of us teaching health law, and our students, in many different ways. the essays in this issue reflect only a fraction of the creativity in health law teaching today. they take us from food insecure neighborhoods in chicago and indianapolis to rural villages in eastern ethiopia. they are written by both clinicians and doctrinal scholars. they span the gamut from some of the most experienced and respected health law professors in the united states to law professors only a few years out of school. what they l. see jennifer s. bard, "practicing medicine and studying law": how medical schools used to have the same problems we do and what we can learn from their ef­ forts to solve them, 10 sea'iti.ej.forsoc.just.135 (2011). 2. id at 136. · 3. frank pasquale, aals panel on teaching health law: a tour de force, health: reformwatch(jan. 14, 2012), http://www.healtbreformwatch.com/2012/01/14/aals-panel­ on-teaching-health-law-a-tour-de:-forcel (reviewing the panel and. concluding that "[t]he health law section at aals put on a truly outstanding program"). · 4. see generally m. gregg blocbe, the emergent logic of health law, 82 s. cal. l. rev. 389, 396 (2009) ("[t)he law of health care provision and the health care system itself are best understood and acted on as emergent systems.''). . s. these essays do not reflect the growing interest in. providing experiential learning for health law students in transactional work. see jonathan todres, beyond the case meth­ od: teaching transactional law skills in the classroom, 37 j.l. med. & ennes 375 (2009) (pointing out that health law cla8ses, like most law school classes, are· overly weighted to­ wards litigation). 2012] introduction 391 share is a passion for teaching and for using law to solve the difficult legal issues which arise when people seek to deliver and receive health care. my hope is that these essays will inspire you to develop your own programs to interact with the real world outside of our classrooms and will give you strong tools with which to do so. i. background: how a panel became a symposium these essays are both from law professors who spoke on the panel in washington, d.c. and those who responded to a call for papers but were not on the panel. because. the response to the call for papers generated three times as many proposals as there were slots on the panel, i approached the editors of the indiana health law review, who had already agreed to publish the proceedings of the panel, if they would extend their offer to in­ clude papers by those who submitted proposals describing a program fittin~ the panel's theme of bringing health law teaching outside of the classroom .. they graciously agreed, although it doubled their workload, and this vol­ ume is the result. all of us in the aals section on law, medicine and health care owe a debt of gratitude to the generous and skillful help of the editors of the in­ diana health law review, especially its editor-in-chief courtney campbell, in bringing this project to publication. each of the essays below represents the distillation of considerable creativity and hard work. they are arranged in two groups. the first group includes those who spoke at the panel in washington, d.c., on january 7, 2012. the second comes from a class of papers that generated three times as many proposals as could be accommodated on a single panel. ll. the p anei,jsts a. wendy parmet the oldest and most comprehensive program of involving law stu­ dents and law professors with the world of their clients is the co-op pro­ gram · at northeastern university in boston, massachusetts. professor wendy parmet, associate dean for· academic affairs and george j. and kathleen waters matthews distinguished university professor of law, not only has taught health law at northeastern for more than twenty-five years, she herself has been directly involved in landmark health law litigation while at the same time carrying on her duties as a professional. professor 6. there were many excellent submissions that did not directly describe a program. each deserves to be. the subject of a presentation or law review article. moreover, not all of those proposing to speak about their proiram on the panel chose to write an essay for this issue. 392 indiana health law review [vol. 9:2 parmet writes about the particular benefits of a co-op program for health law students noting that "perhaps because many students in a health law course will have either just finished working on a health law co-op or are in the process of looking for one, our health law students tend to be extremely engaged participants in classroom discussions." in addition to writing about her students' experiences with co-op, 7 she also writes about how co­ op has enriched her experiences as a faculty member. recounting how she became co-counsel in the landmark civil rights case bragdon v. abbott,8 she writes that she became involved "after a student who had worked on the early stages of the case on a co-op with the aids law project at gay and lesbian advocates and defenders" introduced her to his supervisor, ben­ nett klein, with whom she went on to bring the case to the supreme court of the united states.9 b. charity scott charity scott, catherine c. henson professor of law and director for the center for law, health & society, at georgia state university's college of law in atlanta, georgia, created and is the director of the center for law, health & society. because in 2009 it hosted a conference titled "in­ terdisciplinary collaborative education: partnerships between law schools and the health professions," i knew she would serve as a rich resource. in fact, her presentation consisted of outlining ten separate categories of en­ gagement. the article professor scott has written expanding on her talk, collaborating with the real world: opportunities for developing skills and values in law teaching, is a wonderful resource for those who seek to step out of the classroom. 10 it also, however, gives her an opportunity not just to describe ways that health law professors can step outside of the classroom into the real world, but why they should. she writes, [r]eal-world collaborations can mix up the law class­ room routine and get students' attention, a first step in improving their learning. when students see real problems or real people, their motivation to engage with them constructively is significantly enhanced. real-world collaborations also offer authentic learn­ ing opportunities, which can deepen learning and make it lasting. students are not the only ones who 7. wendy parmet, beyond externships: health law co-ops, 9 ind. health l. rev. 399,400 (20 12). 8. bragdon v. abbott, 524 u.s. 624 (1998). 9. parmet, supra note 4, at 406. 10. charity scott, collaborating with the real world: opportunities for developing skills and values in law teaching, 91nd. healthl. rev. 409(2012). 2012] introduction benefit from such collaborations: they can promote your own professional engagement and development and may even :further your law school's mission. 11 393 professor scott also addresses directly the reluctance that some of us may feel in stepping past the podium: classroom professors do not need to become clinical professors or start teaching lawyering skills courses. instead, they can collaborate with clinical professors, practicing lawyers, and other professionals outside their classrooms in settings that relate to their doctri­ nal fields. such collaborations can effectively draw on others • expertise and skills to extend and deepen their students' learning and thereby better prepare them for real-world practice.12 c. marshall kapp marshall k.app, director, florida state university center for innova­ tive collaboration in medicine & law; professor, fsu college of medicine department of geriatrics; courtesy faculty, fsu college of law in talla­ hassee, florida, approaches engagement between the legal and medical community not as an issue incorporated into the curriculum but as a cur­ riculum in itself. professor kapp bridges the fields of legal and medical education. before being hired by fsu to start the center he was the gar,. win distinguished professor of law and medicine at southern illinois uni­ versity schools of law and medicine. he also is professor emeritus from wright state university school of medicine and served for more than twen­ ty years as a member of the adjunct faculty at the university of dayton school of law. he writes in a collaborative center in medicine and law: lessons from a disruptive innovation, 13 that ''the medicine-law center has since its inception tried to operationalize its mission by slowly developing, on a trial-and-error basis, a portfolio of activities with real world connota­ tions that is intended to capitalize on potential areas of shared interests and values between physicians and attomeys."14 in describing the programs he has launched he provides an inspirational model for law professors interest­ ed in building meaningful ties with the health care community. although, as he points out, an effort on the scale of his center requires a substantial 11. ld at 454. 12. ld. at414. 13. marshall kapp, a collaborative center in medicine and law: lessons from a disruptive innovation, 91nd. healml. rev. 455 {2012). 14. ld. at458. 394 indiana health law review [vol. 9:2 financial endowment, "[ o ]perationalizing within an academic center an ac­ tive, ongoing, synergistic interaction between the medical and legal profes­ sions is a challenge, but one whose ultimate objectives-for both the public and members of the respective professions-are well worth the necessary investment of time, treasure, and energy." while few of us have the re­ sources to build a center as he has, all of us can learn how to reach out to our colleagues in health care. d. jonel newman my initial inspiration for the panel came from attending the impres­ sive presentation by professors jonel newman and melissa swain ·at the 2011 salt teaching conference in which they described the health and elder law clinic which is a medical legal partnership with the miller school of medicine. professor newman is the director of this clinic, and professor swain the deputy director at the university of miami school of law in coral gables, florida. professor newman, who is currently an as­ sociate professor of clinical legal education, brought with her to academe a distinguished record as a civil rights attorney, so her teaching is always in­ formed by her own real world experience. newman's article miami's med­ ical-legal partnership: preparing lawyers and physicians for holistic practice15 describes how their clinic's clients are patients facing a panoply of legal problems related either to their efforts to pay for health care or for the hurdles of daily living for those living well under the poverty line such as land lord tenant disputes. the growing number of medical legal partnerships at law schools across the country presents an opportunity for collaboration between col­ leagues who identify themselves primarily as clinical professors who are supervising a health law clinic and for lack of a better word, non-clinical professors whose work so far has not involved this task.16 in addition to representing clients, prof. newman has developed a program where law students and medical students work in a team with the law students accompanying the medical students on rounds and the medical students attending client meetings. both benefit from getting a greater un­ derstanding of the clients and patients for whom they will be working, but just as important they learn more about each other. 15. jonel newman, miami's medical-legal partnership: preparing lawyers and physicians for holistic practice, 91nd. hbalm l. rev. 471 (2012). 16. jane r. wettach, the law school clinic as a partner in a medical-legal partner­ ship, 15 tenn. l. rev. 305 (2008); amy ken, helping clients at the intersection of law and medicine, 33 pa.law. 38 (2011). 2012] introduction 395 e. sallie thieme sanford professor sallie thieme sanford of the university of washing­ ton school of law in seattle, washington, who recently came into academe after a distinguished career as an assistant attorney general representing the university ofwashington's medical center, has brought health law not just out of the classroom, but out of the country. in her talk, teaching health law in rural ethiopia: using a pepfar partnership framework and in­ dia's shanbaug decision to shape a course, professor sanford describes a month-long intensive health law and policy course she taught at haramaya university college of law in eastern ethiopia. in her essay, she offers as­ sistance to others who would like to offer a similar course by providing an outline as well as suggested source material for teaching in what she de­ scribes as "in low-income countries with rapidly expanding health sys­ tems."17 iii. proposals a. michele mekel in putting theory into practice: thoughts from the trenches on de­ veloping, a doctrinally integrated semester-in-practice program in health law and policy, 18 professor michele mekel of southern lllinois school of law in carbondale, illinois, describes how she and her colleagues em­ braced experiential learning by developing the siu health law & policy semester-in-practice program, which is a full-time, semester-long student immersion in a designated health law and policy practice setting. the pro­ gram is remarkable because it follows the advice of the carnegie report to not merely teach mechanical skills but also merges both the hands-on expe­ rience of a full-time externship with the in-class components of a doctrinal course. as. she describes it, "the program features a full-time health law and policy field placement coupled with a robust classroom component and concurrent courses in substantive health law." b. emily benfer emily benfer, a clinical professor of law at loyola university of chicago school of law and the founder and director of the health justice 17. sallie sanford. teaching health law in rural ethiopia: using a pep far part­ nership framework and india's shanbaug decision to shape a course, 9 ind. health l. rev. 485, 499 (2012). 18. michelle mekel, putting theory into practice: thoughts from the trenches on developing, a doctrinally integrated semester-in-practice program in health law and policy, 9 ind. health l. rev. 503 (2012). 396 indiana health law review [vol. 9:2 project, writes in the health justice project: a collaborative commitment to solving real world problems19 about taking a holistic, rather than pure­ ly legalistic, approach to confronting the issues of poverty, food insecurity and ill health of the chicago community in which the law school is located. the project, which grew from a single clinic, ''united the surrounding com­ munity, attracting partners from the medical, social work, public health and legal professions, including erie family health center, northwestern uni­ versity family medicine residency program, equip for equality, lawyers committee for better housing, and aids legal council of chicago" with loyola's own school of law's beazley institute for health law and policy legal clinic (named, health justice project) and the school of social works' institute on aging and intergenerational study and practice. in addition, the health justice project hosts loyola university masters of public health students "who study the effect of the partnership on patient health and schweitzer fellows who select a discrete public health project in the com­ munity and collaborate with partners to develop solutions." together they have joined forces to pool their skills and talents of a community to address that community's most pressing problems. she writes that since taking its first patient/client in 2010, the health justice project has served over 400 patients of erie family health center, contributed pro bono hours that are the equivalent of over $2 million in attorneys' fees, and obtained reimbursement of medical expens­ es to erie family health center after winning medi­ caid denial appeals. in the case of just one patient, the reimbursement was valued at over $25,000. to further the. interdisciplinary partnership, students reg­ ularly train over seventy health care providers in the social determinants of health and work on interdisci­ plinary teams to address policy issues. together, they have commented on federal and local rulemaking re­ lated to public health, met with local policy makers and board of education members, worked with na­ tional non-profits, and visited capitol hill to educate legislators on the collaborative model.20 c. christine nero coughlin christine nero coughlin, director, legal analysis, research & writ19. emily benfer, the health justice project: a collaborative commitment to solv­ ing real world problems, 91nd. health l. rev. 521 (2012). 20. id at529. 2012] introduction 397 ing professor of legal writing at wake forest university school of law in winston salem, north carolina, who also has appointments in the wake forest university graduate school of arts and sciences and the wake for­ est university school of medicine's translational science institute, is di­ rectly confronting the divide between doctors and lawyers, which is making it so difficult for us to join forces in solving the problems of health care de­ livery. she writes in legal methods for medical professionals year 2: shifting negative attitudes21 that "last year, wake forest university school of medicine began offering fourth-year medical students a month­ long rotation in legal education housed at the wake forest university school of law. one primary goal was to shift some of the negative atti­ tudes that may exist between physicians and lawyers. ,,22 prof. coughlin addresses the logistical and cultural issues which can make it difficult for law students and medical students to interact in meaningful and sustained dialog. she reports that while only in its first year, the program was suc­ cessful in creating opportunities for engagement and dialog. she writes that "we discussed the fact that with many medico-legal issues there are actual­ ly more than two sides to the story. we had a heated discussion on the role that religion, spiritual beliefs, socioeconomic concerns and political prefer­ ence may play on a political response, or lack thereof.'.23 in the evaluation, one student wrote, [i]t's easy to come into the class having stereotypical thoughts regarding lawyers-ruthless, ambulance­ chasing, etc. learning more about the law and the in­ tricacies involved, knowing that its very easy to have two, three, four sides to a story gives the [legal] pro­ fession a lot more credibility in my eyes. things are not always black and white, and ethical and moral di­ lemmas really require lawyers for the public good. 24 d. dea. c. lott dea c. lott, clinical adjunct professor of law & director of out­ reach indiana university robert h. mckinney school of law health and human rights clinic in indianapolis, indiana, directs the health and hu­ man rights clinic ("hhrc") which has entered in a medical:-legal part­ nership (mlp) with a specific health care provider, the wishard hospital, which "operates westside health center ("westside") ... and provides the 21. christine nero coughlin, legal methods for medical professionals year 2: shifting negative attitudes, 91nd. heal'ih l. rev. 533 (2012). 22. /d. at 537. 23. /d. at 543. 24. /d. at 544. 398 indiana health law review [vol. 9:2 hhrc with access to [its facility.]"25 like professor benfer's clinic in chicago, the hhrc serves primarily the low income area approximately two miles west of the law school's campus. professor lott writes that be­ cause the clinic is directly associated with a healthcare setting, "there have been several requests for drafting of advance directives for disabled or ter~ minally ill clients. there has been a consistent stream of uninsured or un­ derinsured patients seeking assistance in determining eligibility for and appealing denials or terminations of government programs that provide health care and disability benefits.',z6 in addition to their own representa­ tion of clients, the clinic has worked to expand access to legal services by launching "a pilot pro bono program ... designed to establish a system of outreach and coordination for pro bono attorneys."27 she writes further that although the "program was created to assist newly admitted attorneys with the transition from law school to practice while providing pro bono repre­ sentation to im~overished and underserved populations throughout the indi­ anapolis area." 8 e. kathleen noonan and sarah davis finally, professors kathleen noonan and sarah davis write about two clinical programs at the university of wisconsin law school that provide experiences to students interested in health law: the center for patient partnerships ("cpp"), and the government and legislative clinic ("glc"), which bring law students in direct contact 'with the real world. the cpp is one of a few law school clinics which actively integrates not just law stu­ dents but also medical, pharmacy, public affairs, public health, and other disciplines. since health care is by its nature multi-disciplinary, they are teaching students within the context that they will practice. the glc is well-but not uniquely-suited to the law school's location in wisconsin's capital city. students get experience working with government clients on legal issues with policy significance. because most state representatives work with little or no staff, it is likely that this kind of relationship could be arranged even if a law school were not actually in the same city as the capi­ tal. i hope you find the work of these professors as inspiring as i have and wish you all great success in developing your own programs. 25. dea lott, teaching holistic justice: medical-legal partnerships in the clinical setting, 9 ind. health l. rev. 547,551-52 (2012). 26. /d. at 553. 27. /d. 28. /d. if addiction is a mental disease, let's start treating it like one: an additional recommendation for the indiana general assembly's prenatal substance abuse commission matthew derringer • i. introduction .•.•••.•...•.......•.••••.•••.•••.••.••.•.•....••.•...••.•...•.•.•.....••....•• 142 it. background:prenatalsubstanceabuseand governmental intervention •••..••••.....••..••••••.••••••...••••......••..... 144 a. the debate at its core: two sides of the coin ......................... 144 b. development of governmental intervention ............................. 145 1. prevention and treatment ................................................... 146 2. punishment .......................................................................... 146 a. criminal prosecution in general .................................. 14 7 b. criminal prosecution in indiana: one small step ........ 148 c. indiana's current judicial approach to pregnant illegal drug users ............. ; ....................................................... 149 1. the procedure ..................................................................... 149 2. the problem ........................................................................ 150 d. a more recent analysis of indiana's governmental intervention .............................................................................. 151 1. in general ........................................................................... 151 2. alcohol, tobacco, and drug use by pregnant women in indiana 2006 study ....................................... ~ ................. 152 3. prenatal substance abuse commission: 2009 final report ................................................................ 153 iti. analysis: an additional recommendation: recognizing the concept of addiction as a mental disease ................... 155 a. addiction as a mental disease .................................................. 155 b. civil commitment ..................................................................... 156 1. indiana's civil commitment framework ........................... 156 a. dangerous .................................................................... 156 b. gravely disabled.; ......................................................... 157 c. procedure ..................................................................... 158 2. civil commitment in other states ...................................... 160 3. legislative will and public policy ...................................... 161 a. recent indiana legislation ............................................ 161 b. public policy and the united states supreme court .... 162 iv. solutionpresented .................................................................... 163 a. application of existing law ...................................................... 163 * j.d. candidate, 2011, indiana university school of law indianapolis; b.a., 2003, ball state university. 142 indiana health law review [vol. 8:141 b. clarification and expansion of existing law ........................... 164 c. a possibility for future legislative action and response to opposing viewpoints ............................................................. 165 1. for consideration: a point of agreement with the prenatal substance abuse commission final report ......... 165 2. opposing viewpoints .......................................................... 166 v. conclusion .................................................................................. 168 i. introduction on august 15, 2009, the indiana general assembly's prenatal sub­ stance abuse commission issued a final report, the culmination of over three years of research and analysis, and part of the state's "continued ef­ fort to improve the outcomes of pregnanc[ies] in indiana. " 1 the final re­ port, discussed in detail below, included findings and recommendations for the general assembly's consideration in formulating a more thorough leg­ islative response to the use of alcohol, tobacco, and illegal drugs by preg­ nant women in indiana.2 recommendations the general assembly intend to consider during future legislative sessions, however, remain to be seen. the use of alcohol, tobacco; and illegal drugs by pregnant women is a significant public health issue in indiana as well as all other states. alt­ hough numbers vary, recent estimates in indiana show that approximately twenty percent of pregnant women smoke cigarettes, ten percent use alco­ hol, and five to six percent use illegal drugs.3 however, a significant obsta­ cle to this issue is a state's legal ability to address the behavior. after all, use of alcohol and tobacco by adults is not usually illegal behavior, even by pregnant women. further, there does not seem to be any intention in indi­ ana to prohibit such behavior. lliegal drug use by pregnant women is per­ haps the only behavior of the three issues mentioned above, that a state, and indiana in particular, could approach through a legal framework because the root of the problem involves activity which is already illegal in every state. therefore, the recommendations proposed in the prenatal substance abuse commission's final report involving illegal drug use by pregnant women in indiana should be carefully considered 1. ind. prenatal substance abuse comm'n, final report: findings and recommendations 4 (2009), available at http://www.in.gov/legislative/senate_democrats/ files!psacfinalreport.081509.pd£ 2. see generally id. 3. 'fbrrbll w. zollinger, bt al., ind. unlv. school of mbd., alcohol, tobacco and drug usb by pregnant women in indiana: a study for thb indiana state department of health 5 (2006), available at http://www.in.gov/legislative/igareports/ agency/reports/isooh30.pdf; see also page mcguire linden, drug addiction during preg­ nancy: a call for increased social responsibility, 4am. u. j. gender& l. 105, 107 (1995) ("[ a]pproximately eleven percent of all pregnant women have used illegal drugs while preg­ nant, and of those eleven percent, seventy-five have used cocaine during a pregnancy."). 2011] treating addiction as a mental disease 143 proposals have been developed for the general assembly's review due to various problems with the current approach to the issue of illegal drug use during pregnancy. the current approach in indiana does not take into account the emerging, medically validated assertion that chemical ad­ diction is a mental illness. there is also a lack of recognition that under indiana law, addiction is categorized as a mental illness.4 the proposed approach included herein, detailing the legislative framework and procedure for civil commitment in the context of mental illness in indiana, could also be employed for pregnant illegal drug users. addiction is considered a mental illness in indiana, and the state should begin treating it as such.5 the consequence of unchecked addictions of pregnant drug users is an indi­ vidual who is not only mentally ill but who is also dangerous to the point of presenting a substantial risk to another-the unborn fetus. the approach proposed here is a narrowly tailored governmental intervention which serves a compelling state interest in the protection of unborn fetuses. as demonstrated in the two cases below, there are a wide range of be­ liefs as to how prenatal substance abuse should be addressed. as is often the case in our country, there are almost as many different governmental approaches to the problem as there are states.6 this begs the question: where does indiana stand in the debate? this note considers whether indi­ ana's current response is effective in mitigating the harm caused when pregnant women use illegal drugs, and whether there is a more efficient leg­ islative and procedural framework, either under current statutes or which could be enacted, that could be adopted by indiana in an effort to further protect the future lives of unborn children exposed to drugs by chemically­ addicted, mentally ill mothers. part ii of this note discusses the development of governmental re­ sponses to the issue of prenatal substance abuse in general, and details indi­ ana's current approach to the issue. part ii also examines a 2006 study conducted by the indiana university school of medicine for the indiana state department of health, which led to the indiana general assembly's creation of the prenatal substance abuse commission and that panel's sub­ sequent final report. part ill analyzes the concept of addiction as a mental disease, and is followed by a detailed analysis of the legal framework and policy implications for civil commitment, and the feasibility of enacting a different approach in indiana. part n presents solutions for the issues raised in this note, as well as a discussion of opposing viewpoints. the note is concisely concluded in part v with a brief final thought. 4. see, e.g., ind. code§ 12-7-2-130 (2010). 5. see infra part iii.a. 6. see addington v. texas, 441 u.s. 418, 431 (1979) ("the essence offederalism is that states must be free to develop a variety of solutions to problems and not be forced into a common, uniform mold."). 144 indiana health law review [vol. 8:141 ii. background: prenatal substance abuse and governmental intervention a. the debate at its core: two sides of the coin the issue of a state's legal response to the use of illegal drugs by pregnant women usually arises when a high profile case gets extensive me­ dia coverage and a segment of the populace becomes outraged at the lack of emphasis on personal responsibility on the pregnant mother's part. take, for instance, the highly publicized 2005 case oftayshea aiwohi in hawai'i. in 2004, ms. aiwohi was convicted of manslaughter, partly due to her ad­ mission to smoking crystal methamphetamine for four days up to and in­ cluding the day she gave birth to treyson aiwohi on july 15, 2001.7 treyson aiwohi died two days later, on july 17, 2001, and the medical ex­ aminer testified in the grand jury proceeding that the cause of treyson's death was the toxic effects of methamphetamine, "consistent with exclusive prenatal exposure through the mother."8 in its unanimous november 29, 2005 decision, the supreme court of hawai'i reversed ms. aiwohi's conviction, holding that a fetus is not within the statutory definition of "person" for the purposes of a manslaughter charge in hawai 'i. 9 therefore, the court reasoned that ms. aiwohi could not be convicted for her prenatal use of illegal drugs because treyson ai­ wohi was not a "person" at the time of the proscribed conduct. 10 while cit­ ing examples from seven states, the supreme court of hawai'i stated, "an overwhelming majority of the jurisdictions confronted with the prosecution of a mother for her own prenatal conduct, causing harm to the subsequently hom child, refuse to permit such prosecutions."11 in contrast to aiwohi, is the south carolina case of cornelia whit­ ner.12 in 1992, ms. whitner was convicted of criminal child neglect due to her ingestion of crack cocaine during the third trimester of her pregnancy.13 she was sentenced to eight years in prison.14 similar to the aiwohi case, the question in whitner arose as to whether the word "child" in south caroli­ na's child abuse and endangerment statute encompassed an unborn fetus. 15 the result, however, was quite different from aiwohi. in 1997, the su­ preme court of south carolina held that the term "child" does include "via7. state v. aiwohi, 123 p.3d 1210, 1210-11 (haw. 2005). 8. /d. 9. /d. at 1224. 10. /d. (noting "[e]ven if, arguendo, the statutory language were perceived to be ambiguous, the term 'person' may not be construed so as to include fetuses."). 11. id. at 1214. 12. whitner v. state, 492 s.e.2d 777,778-79 (s.c. 1997). 13. /d. 14. /d. 15. /d. at 778. 2011] treating addiction as a mental disease 145 ble fetuses," stating, ''we do not see any rational basis for finding a viable fetus is not a 'person' ... [i]ndeed, it would be absurd to recognize the via­ ble fetus as a person for purposes of homicide laws and wrongful death statutes but not for purposes of statutes proscribing child abuse."16 further, the court stated that to hold as such was a continuation of long-standing established law in the state.17 the court also recognized its relatively unique position on the issue, stating, "we are well aware of the many deci­ sions from other states' courts throughout the country holding maternal conduct before the birth of the child does not give rise to criminal prosecu­ tion under state child abuse/endangerment or drug distribution statutes."18 the united states supreme court denied certiorari.19 needless to say, south carolina was not one of the seven states the aiwohi court cited in its survey of the "majority" of states who refuse to permit prosecution of mothers for prenatal conduct. 20 b. development of governmental intervention the dangers of illegal drug use during pregnancy are well document­ ed, but the problem became nationally recognized in the 1980's after the explosion of crack cocaine use produced the media handle "crack babies" for children born from these unfortunate situations.21 heroin use has also been implicated in the context of harm to the unborn child.22 more recently, the rapid increase in methamphetamine use in the united states has come into the focus of state legislatures, though studies are still being conducted to determine the exact effects of prenatal methamphetamine use.23 regard­ less of the illegal drug in question, one can assume that prenatal substance 16. !d. at 780; accord la. rev. stat. ann. § 14:2(a)(7) (2008) ('"person' includes a human being from the moment offertilization and implantation .... "). 17. whitner, 492 s.e.2d at 779 ("south carolina law has long recognized that viable fetuses are persons holding certain legal rights and privileges."). 18. id at 782. 19. whitner v. south carolina, 523 u.s. 1145 (1998). 20. state v. aiwohi, 123 p.3d 1210, 1214 (haw. 2005) (the seven states cited include new york, ohio, texas, arizona, washington, florida, and wisconsin). 21. ferguson v. city of charleston, 532 u.s. 67, 70 n.l (2001) ("[t]he problem of 'crack babies' was widely perceived in the late 1980's as a national epidemic, prompting considerable concern both in the medical community and among the general populace."). 22. see linden, supra note 3, at 108. ("many of the adverse effects on fetal develop­ ment associated with cocaine use during pregnancy also apply to use of heroin and other narcotics by pregnant women."). 23. see linda c. fentiman, in the name of fetal protection: why american prosecu­ tors pursue pregnant drug users (and other countries don't). 18 colum. j. gender & l. 647, 655 (2009) ("today, sensational reports about methamphetamine abuse frequently make headlines across the united states, and law enforcement officers and the media frequently profess its harmful effects on users, their children, and fetuses. however, there is little data demonstrating a causal relationship between exposure to methamphetamine in utero and problems of infant development. "). 146 indiana health law review [vol. 8:141 abuse does nothing but put unborn fetuses in a less than optimal gestation situation. in most instances of prenatal substance abuse, states approach the issue from one of two ends of the spectrum: prevention and treatment, or punishment. 1. prevention and treatment most states overwhelmingly prefer prevention and treatment ap­ proaches to the problem over punishment.24 almost every state has at least one government-mandated program aimed at educating pregnant women about the dangers of prenatal illegal drug use.25 from the prevention as­ pect, approaches can focus either on preventing pregnant women in general from using illegal drugs or preventing women of childbearing age from us­ ing illegal drugs. the treatment approach is "in keeping with evidence­ based medical recommendations that support treatment approaches to drug use or addiction, not punitive ones."26 further, "[a]ddiction research has found that treatment and education strategies are effective and less costly than punitive ones.'m typical substance abuse treatment programs consist of a brief detoxification period ("detox"), outpatient treatment where the individual attends group meetings once per week, intensive outpatient treatment involving attendance at group meetings three times per week, or inpatient treatment at a facility dedicated to around-the-clock substance abuse treatment.28 in either the prevention or treatment approaches, re­ sources are expended by the state with the hope that pregnant substance abusers will recognize the dangers involved with their behavior and enact a change. 2. punishment punishment is the minority approach to the issue, but it is not without innovative avenues toward implementation, and often strong public sup­ port. 29 when expecting or new mothers are prosecuted for alleged acts 24. see zollinger, et al., supra note 3, at 6 (noting, "[t]reatment programs exist in all states."). 25. lynn m. paltrow et al., governmental responses to pregnant women who use alcohol or other drugsyear 2000 overview, part 1, women's l. project and nat'l advocates for pregnant women (last updated oct. 2000), http://www.drugpolicy.org/ library/ gov _responses_ overview _p l.cfm. 26. lisa h. harris & lynn paltrow, the status of pregnant women and fetuses in u.s. criminal law, 304 jama 1697, 1698 (2003). 27. id. 28. see generally substanceabusecenters.com, http://www.substanceabusecenter .com/indiana! (last visited mar. 13, 2010). 29. see mark curriden, holding mom accountable: roe v. wade does not prevent criminal prosecution of prenatal child abuse, 16 a.b.a. j. 50, 51 ( 1990) ("a survey of 15 southern states by the atlanta constitution found that 71 percent of the 1,500 people polled 2011] treating addiction as a mental disease 147 committed during pregnancy, those attempted prosecutions "are generally premised on one of the following concepts: delivery of a controlled danger­ ous substance to a minor, child endangerment, child abuse, and homicide by child abuse. "30 this means that, "[ w ]hen pregnant women are prosecuted for potential fetal harm, courts are asked to determine if existing criminal statutes can be expanded and applied to pregnant women's behavior and health conditions."31 it is this statutory wrangling which usually presents the main problem for prosecutors. additionally, there is the perceived problem that by proscribing a pregnant woman's conduct, "the logic of al­ lowing such prosecutions would be extended to cases involving smoking, alcohol ingestion, the failure to wear seatbelts, and any other conduct that might cause harm to a mother's unborn child."32 further still, even in juris­ dictions where prosecutions can be sustained, fear of criminal prosecution could deter desirable behavior like seeking out prenatal medical service throughout pregnancy and hospitalization at the time of birth for fear of criminal prosecution. 33 a. criminal prosecution in general as mentioned in the whitner case above, there are instances of women being criminally prosecuted and convicted for their prenatal use of illegal drugs. eleven states, other than indiana, have attempted prosecutions of favored criminal penalties for pregnant women whose illegal drug use injures their babies."). 30. wade l. house, article, state v. armstard: a call to arms for the defense of children, 36 s.u. l. rev. 263, 267 (2009); see also krista stone-manista, comment, pro­ tecting pregnant women: a guide to successfully challenging criminal child abuse prose­ cutions of pregnant drug addicts, 99 j. crim. l. & criminology 823, 824 (2009) ("prosecutors bring criminal charges against pregnant women who use illicit drugs under a wide range of state statutes, including but not limited to those governing criminal child abuse, criminal child mistreatment, and attempted first-degree intentional homicide."). 31. harris & paltrow, supra note 26, at 1697; see also linden, supra note 3, at 120 ("in theory, the use of abuse and neglect statutes does further the goal of maintaining the mother-child relationship with the primary goal of state intervention under these statutes being reunification of the family.''). 32. state v. wade, 232 s.w.3d 663, 666 (mo. ct. app. 2007); see also lynn m. pal­ trow, pregnant drug users, fetal persons, and the threat to roe v. wade, 62 alb. l. rev. 999, 1021-22 (1999) ("virtually no state ... punishes drug use per se. as a result, the prose­ cutors are in fact seeking to have the judiciary create a new crime of drug use, and then only for one group of people--pregnant women.''); cf. tiffany lyttle, note, stop the injustice: a protest against the unconstitutional punishment of pregnant drug-addicted women, 9 n.y.u. j. legis. & pub. pol'y 781, 783 (2006) ("[a] state's punishment of a drug-addicted woman for her actions during pregnancy violates the eighth amendment's cruel and unusu­ al punishment clause because the state is penalizing the woman for her status as a drug addict."). 33. carol gosain, protective custody for fetuses: a solution to the problem of ma­ ternal drug use? casenote on wisconsin ex rei. angela v. kruzicki, 5 geo. mason l. rev. 799, 839 (1997) ("data indicates [sic] that criminal prosecutions of women who abuse drugs during pregnancy have resulted in an increase in the number of unsupervised births taking place outside hospitals.''); see also linden, supra note 3, at 120 (''failure to receive prenatal care is extremely harmful to both mother and fetus.''). 148 indiana health law review [vol. 8:141 women based on their prenatal drug use.34 what is significant about whit­ ner is that the prosecution proceeded under the south carolina statute per­ taining to the unlawful conduct towards a child, which is, in essence, a child abuse statute.35 it was the whitner court's interpretation that "child" in­ cluded "viable fetuses" which allowed the prosecution to stand, in direct contrast to the finding by the aiwohi court, which resulted in ms. aiwohi's conviction being reversed. it would seem that courts would have to make the determination on a state-by-state basis as to whether or not a viable fe­ tus is considered a "child" for each child abuse statute, or for any other stat­ ute a prosecutor might attempt to use in criminally charging a pregnant substance abuser. b. criminal prosecution in indiana: one small step indiana courts have made the determination with regard to the child abuse statute listed in section 35-46-1-4 of the indiana code (neglect of a dependent), that, similar to hawai'i, the term "dependent" does not include an unborn child. 36 as such, attempts to prosecute pregnant women under the indiana child abuse statutes often do not result in sustainable convic­ tions. however, one indiana court addressing the issue seemed to imply that an amendment of the statute by the indiana general assembly to expressly include unborn children within the definition of "dependent" would be all that is required for indiana courts to apply a standard similar to the south carolina standard in whitner.37 with such an amendment, there does not seem to be much more for an indiana court to interpret. the herron court specifically stated, "we cannot expand the general assembly's definition of a dependent and, consequently, the intended application of the neglect of a dependent statute, beyond the fair meaning of the words used. sections 35-46-1-1 and 35-46-1-4 of the indiana code do not criminalize conduct that occurs prior to a child's birth."38 this language signaled that a legisla­ tive amendment to the statutes in question would make convictions of preg­ nant women for using illegal drugs under the child abuse statutes in indiana sustainable. however, criminal prosecutions of pregnant drug users have 34. house, supra note 30, at 268-72 (the states: florida, michigan, pennsylvania, tex­ as, ohio, nevada, maryland, missouri, kentucky, louisiana and south carolina). 35. see whitner v. state, 492 s.e.2d 777, 778 (s.c. 1997); s.c. code ann.§ 63-5-70 (2008). see generally richard karel, punishing pregnant women who abuse drugs doesn't work, psycidatric news, oct. 16, 1998, http://www.psychiatricnews.org/pnews/98-1016/pregnant.html ("the whitner case has become a rallying point for both opponents and proponents of punitive, coercive interventions for pregnant substance abusers."). 36. robinson v. state, 894 n.e.2d 1038, 1042 (ind. ct. app. 2008) ("[t]he definition of 'dependent,' as used in this statute, does not include an unborn child"); see ind. code§ 35-46-1-4 (2004). 37. herron v. state, 729 n.e.2d 1008, 1011 (ind. ct. app. 2008). 38. /d. 2011] treating addiction as a mental disease 149 been widely criticized and are not without drawbacks. further, indiana has shown a preference for a non-criminal approach in its current procedure for addressing the issue. c. indiana's cu"ent judicial approach to pregnant dlegal drug users 1. the procedure in indiana, the current state response for when a newborn child tests positive for illegal drugs falls within the statutory area of family and juve­ nile law. the indiana code defines circumstances under which a child born with any amount of an illegal substance in their body can be determined a "child in need of services" ("chins").39 in such a situation, an immediate oral report must be made to the department of child services ("dcs") or the local law enforcement agency for the beginning of investigative ac­ tion.40 indiana law also provides a statutory abrogation of privileged relation­ ships, including doctor-patient and attorney-client privileges, which effec­ tively dispenses with any question of whether the report could be made in the first place.41 furthermore, indiana makes it a class b misdemeanor to knowingly fail to make this report.42 dcs is required to prepare a written report within forty-eight hours of receiving notification via the oral report.43 if a report is substantiated, the most severe option available is the filing of a chins petition, which invokes the jurisdiction of the juvenile courts to proceed with legal action, could lead to the termination of parental rights.44 indiana courts have clarified that, "[t]he purpose of terminating parental rights is not to punish a parent but to protect the child.'.45 the indiana case in re c.s. is a working example of this approach.46 in that case, a child was born on november 25, 2005, at which time the mother, loretta savage, tested positive for opiates and benzodiazepines and the newborn also tested positive for benzodiazepines. 47 the drug test re39. ind. code§ 31-34-1-10 (2008) (''the child is born with: any amount. including a trace amount. of a controlled substance or a legend drug in the child's body''); § 31-34-1-11 (''the child: has an injury; has abnormal physical or psychological development; or is at a substantial risk of a life threatening condition; that arises or is substantially aggravated be­ cause the child's mother used alcohol. a controlled substance, or a legend drug during preg­ nancy."). 40. see § 31-33-5-4. 41. see ind. code§ 31-32-11-1 (2009). 42. ind. code§ 31-33-22-1 (2008). 43. ind. code§ 31-33-7-4. {2008). 44. ind. code§ 31-33-7-7 (2009). 45. in re i.a., 903 n.e.2d 146, 152 (ind. ct. app. 2009). 46. in re c.s., 863 n.e.2d 413 (ind. ct. app. 2007). 47. id. at 414-15; see also benzodiazepines, u.s. drug enforcement admin., 150 indiana health law review [vol. 8:141 sults were subsequently forwarded to dcs.48 a dcs investigator inter­ viewed loretta savage at the hospital, during which ms. savage admitted to using drugs during her pregnancy.49 dcs then filed a chins petition, four days after the birth of the newbom.50 judicial action was swift: "[a]n initial hearing was held that same day at which savage admitted the allegations of the petition and c.s. was placed in foster care."51 2. the problem the problem with the current approach in indiana is that it is designed to deal with the problem after the birth of the child who has been exposed to illegal drugs. although indiana's current approach deals retroactively with illegal drug use during pregnancy, indiana has never confronted the following question: what should a state do, if anything, with pregnant women who use illegal drugs during pregnancy? although indiana still has yet to address this problem, a few other states have. the goal should be to eliminate exposing fetuses to illegal drugs during pregnancy, while foster­ ing an environment in which the mother can address her addiction. this should be accomplished so as to enable the mother and. child to remain to­ gether after the birth. under the current statutory interpretation of most state child abuse statutes, most recently considered in herron,52 it is evident that the criminal prosecution of prenatal drug abusers generally will not be successful.53 however, this roadblock to criminal prosecution may not necessarily be bad, because there is, perhaps, another set of statutes which would be more useful in prevention of this harmful prenatal exposure to illegal drugs: an overloaded criminal justice system that cannot ad­ equately respond to increased drug abuse-related criminal offenses, and perceptions that the criminal justice system may not be the appropriate means for responding to drug abusers, has highlighted the poten­ tial of civil commitment as an important and distinct alternative for dealing with drug abuse. 54 http://www.justice.gov/dea/concernlbenzodiazepines.html (last visited jan. 2, 2011) (benzo­ diazepines are typically ingested as prescription medication, such as xanax or valium). 48. in re c.s., 863 n.e.2d at 414-15. 49. /d. 50. id. 51. /d. 52. herron v. state, 729 n.e.2d 1008, loll (ind. ct. app. 2008). 53. fentiman, supra note 23, at 647 ("in all but three states-alabama, kentucky, and south carolina-such prosecutions have been declared unconstitutional or the resulting con­ victions have been overturned."). 54. ali john amirshahi & thomas l. hafemeister, civil commitment for drug de2011] treating addiction as a mental disease 151 specifically, there is a possibility that civil commitment, as a kind of mid­ dle ground in the prevention/treatment-punishment spectrum, could become an effective tool in limiting prenatal exposure to illegal drugs. as a first step, however, it would be useful to examine how indiana has reconsidered the government's position on this issue in recent years. · i. in general d. a more recent analysis of imliana 's governmental intervention there is no shortage of information or opinions on how and who should take action in situations involving pregnant illegal drug users, spe­ cifically through the judicial system. as is usually the case with any issue, all sides tend to make valid points. proponents of governmental interven­ tion cite multiple policy reasons to support such intervention, such as the need to "deter or prevent drug abuse during pregnancy, provide appropriate punishment to women deserving of such, or achieve improvements in ma­ ternal or fetal health outcomes."55 among other arguments, opponents of judicial intervention often suggest that most attempts are done through forced interpretations of statutes not specifically tailored to address the is­ sue of prenatal substance abuse (i.e., child abuse and neglect statutes).56 these are just a few reasons usually cited in support of both sides of the issue. 57 the legislature is tasked with, "balancing a woman's right to bodily integrity with society's interest in ensuring healthy pregnancies, and the question of whether punitive approaches will foster--or hinder-healthy outcomes for women and children."58 such an important balancing act of­ ten results in a commissioned study to analyze the issue. pendency: the judicial response, 26 loy. l.a. l. rev. 39,42 (1992). 55. stone-manista, supra note 30, at 825. 56. see generally id. 57. /d. at 837 (summarizing both sides: "pregnant women have been subjected to in­ carceration or other criminal sanctions for a variety of reasons: to prevent them from having access to illegal drugs, to compel them to carry their pregnancies to term, to force them to submit to a physician's orders regarding their care, or to allow the courts in other ways to control and direct a woman's conduct during her pregnancy. instead of improving access to comprehensive maternal and child prenatal care and thus benefiting the fetus and the mother, incarceration of pregnant women may actually result in serious harm, either by restricting access to prenatal care or exposing them to less-than-ideal conditions within the prison itself. incarceration of pregnant women does not help them to overcome their addictions, nor does it serve to protect their fetuses from drug use, as illegal drugs are readily available in prison. although some may argue that women in prison would have better access to prenatal care than they could afford or would choose to seek out otherwise, prisons are not prepared to offer adequate care to pregnant women. "). 58. cynthia dailard & elizabeth nash, the guttmacher report on public policy: state responses to substance abuse among pregnant women, dec. 2000, at 3, available at http://www.guttmacher.org/pubs/tgr/03/6/gr030603.pdf. 152 indiana health law review [vol. 8:141 2. alcohol, tobacco, and drug use by pregnant women in indiana 2006study indiana's approach to the issue of prenatal substance abuse indicates opposition toward judicial intervention, placing the emphasis on raising awareness and focusing on treatment and prevention. at the direction of the indiana general assembly, a study was conducted in 2006 by the indi­ ana university school of medicine for the indiana state department of health as a comprehensive look at the issue of alcohol, tobacco, and drug use by pregnant women in indiana. 59 the report indicated that while the exact prevalence of substance use during pregnancy in indiana is unknown due to a lack of valid and timely data, an estimate based on birth certificate data puts the rate of illegal drug use by pregnant women in indiana at ap­ proximately five to six percent.60 the report notes that this figure likely underestimates the actual figure because it only reflects self-reported illegal druguse.61 the report also stated that there is general agreement that ''the best strategy to reduce the consequences of[alcohol, tobacco, and drug] use dur­ ing pregnancy is to focus on preventing women of childbearing age from using these substances."62 in focusing on substance abuse in general, the report specifically noted that, "[i]t should also be stressed that substance use is a biomedical problem and not a character flaw.'.63 this position follows the trend in medical and drug treatment fields to break away from treating alcoholism and drug addictions as personal choices made by those affected and to move toward classifying the conditions as medical and mental afllic­ tions: experts at the national institute on alcohol abuse and alcoholism and national institute on drug abuse confirm that addiction is not primarily a moral weak­ ness, as it has been viewed in the past, but a "brain disease" that should be included in a review of symp­ toms just like any other biologic disease process. 64 in light of the data analyzed for the study, the report emphasized that the future direction for the state oflndiana in addressing the use of alcohol, 59. zollinger, et al., supra note 3, at 5. 60. !d. 61. !d. 62. !d. at 114. 63. !d. 64. id. (quoting american college of obstetricians and gynecologists, acog com­ mittee opinion no. 422: at-risk drinking and illicit drug use: ethical issues in obstetric and gynecologic practice, 112 obstetrics& gynecology 1449, 1450 (2008).). 2011] treating addiction as a mental disease 153 tobacco, and drugs by pregnant women should focus on prevention and treatment services.65 focusing on prevention and treatment programs "will result in reduced burdens on the health care system and law enforcement agencies.'.66 the report urged the creation of a task force at the state level in order to address the issue, stating: it will be essential to establish a state task force which includes state and local policy makers; administrators from public health, mental health and addiction, child welfare, health, education, employment security, criminal justice, and advocacy agencies; representa­ tives from program funding organizations; primary care and [alcohol, tobacco, and drug] treatment pro­ viders; as well as women who used [alcohol, tobacco, and drugs] during pregnancy, to work in unison to remedy these problems. this task force will need to address the prioritization of the above issues and de­ velop a state implementation plan to improve early in­ tervention and treatment for pregnant women using [alcohol, tobacco, and drugs].67 3. prenatal substance abuse commission: 2009 final report following the 2006 study, the indiana general assembly established the prenatal substance abuse commission, with a two year mission to re­ sult in a "final report that contains the findings and recommendations of the commission and an implementation plan to improve early intervention and treatment for pregnant women who abuse alcohol or drugs or use tobacco," to be submitted no later than august 15, 2009.68 the members of the commission included directors of public health agencies, doctors specializ­ ing in the care of pregnant women and addiction treatment of pregnant women, legislators, a prosecuting attorney, a judge, and a nurse specializing in addiction treatment of pregnant women. 69 the august 2009 prenatal substance abuse commission's final report expressed in numbers the im­ pact of prenatal substance abuse in indiana. with approximately 90,000 deliveries per year in the state, "[ o ]ver 900/o [sic] of pregnant substance us­ ers in indiana go undetected."70 prenatal substance abuse can lead to pre65. see zollinger, et al., supra note 3, at 120. 66. /d. 67. id. 68. ind. code§ 5-14-6-3 (p.l. 193-2007, sec. 5) (2007). 69. ind. prenatal substance .abuse comm'n, supra note 1, at 6. 70. id. at3. 154 indiana health law review [vol. 8:141 term delivery of the baby (a delivery before 37 weeks).71 put in economic terms: "with a reduction in preterm deliveries, where the average newborn nursery cost for one pre-term baby is $50,000, the savings ... alone would be in the millions of dollars.'.n note that the savings are only in terms of the reduction of regular pre-term births.73 the savings would be com­ pounded when factoring in the additional savings to be had in the reduction of pre-term, chemically-exposed births, with estimates that the costs of life­ time care for such children range from $750,000 to $1.4 million per child. 74 with regard to treatment and prevention, the report stated: "the state of indiana currently funds multiple programs specifically targeted to preg­ nant women in need of substance abuse and addiction services. however, there is evidence through program enrollment data and underutilized resi­ dential beds that the process to access these resources needs to be im­ proved."75 the prenatal substance abuse commission offered the several recommendations for legislative consideration, including: 71. ld 72. id 73. !d. 1. implementing universal ... verbal screening, inter­ vention and continuous monitoring for pregnant women who screen positive, and appropriate referral for treatment. 2. establishing a routine in-depth surveillance study to estimate prevalence of . . . use among pregnant women. 3. establishing an ongoing cross-agency committee to monitor existing resources, improve collaboration, and carry forward the work of the commission. 4. designate funding to support ongoing training of prenatal providers on universal screening .... 5. authorize funding for surveillance studies to moni­ tor the prevalence of [alcohol, tobacco, and drug] use among pregnant women in indiana .... 6. authorize funding ... to implement the [above] [r]ecommendations .... [and] establishing of a crossagency committee within state government to mini­ mize duplication of services, update resource and ser­ vice information, improve coordination and 74. chrlstopher j. kalotra, ojp drug court clearinghouse and technical assistance project: estimated costs related to tile birth of a drug and/or alcohol exposed baby 1 (mar. 2002), available at http://indianaperinatal.org/downloads /estimatedcosts.pdf; see a/so ind. prenatal substance abuse comm'n, supra note 1, at 6. 75. ind. prenatal substance abuse comm'n, supra note 1, at 11. 2011] treating addiction as a mental disease collaboration in seeking grant funding and otherwise oversee the continuation of. efforts to address this problem in indiana. 76 155 the report does not mention all of the possibilities of judicial intervention for the involuntary implementation of substance abuse treatment for prena­ tal drug abusers. this clearly demonstrates that the focus in the state of indiana has been and will seemingly continue to be on prevention and treatment. ill. analysis: an addffional recommendation: recognizing the concept of addiction as a mental disease a. addiction as a mental disease the inclusion of addiction to narcotics and dangerous drugs within in­ diana's statutory definition of mental illness lays the groundwork for the implementation of civil commitment to address the issue of prenatal addic­ tion. 77 the indiana code defines mental illness, for purposes of the com­ mitment statutes, as "[a] psychiatric disorder that substantially disturbs an individual's thinking, feeling, or behavior and impairs the individual's abil­ ity to function. the tenri includes mental retardation, alcoholism, and ad­ diction to narcotics or dangerous drugs.'m further, advocates for those suffering from substance abuse addiction also push for the disorder's ac­ ceptance alongside other mental illnesses.79 the napw, an organization focused on human and civil rights for low-income women also recognizes that pregnant women who use drugs are struggling with addiction. 80 de­ spite the central agreement that addiction is a mental illness, the legal dis­ tinction has yet to be used to bring additional state resources to the 76. /d. at5. 77. ind. code § 12-7-2-130 (2007); see generally karel. supra note 35 (noting that "[a] diagnosis of substance abuse provides no medical rationale for involuntary commit­ ment" (quoting michael miller, m.d., of the am. soc. of addiction medicine)) 78. § 12-7-2-130. 79. see american college of obstetricians and gynecologists, acog committee opinion no. 422: at-risk drinking and illicit drug use: ethical issues in obstetric and gynecologic practice, 112 obstetrics & gynecology 1449, 1450 (2008) (noting the na­ tional institute on alcohol abuse and alcoholism and the national institute on drug abuse's position that addiction is a '"brain disease' that should be included in a review of systems just like any other biologic disease process."); see also u.s. dep't of health and human serv., mental health: a report of the surgeon general 9 (1999}, available at http://www.surgeongeneral.gov/library/mentalhealth/pdfs/cl.pdf (noting that it is ironic that as advances in the field of mental health were achieved, "each condition was transferred from the mental health field to another medical specialty''}. 80. angela mapes turner, pregnant addicts blur crime debate: authorities waver on punishment for neglect, abuse, j. gazette, (apr. 27, 2008), http://www.joumalgazette.net/ apps/pbcs.dll/article?aid=/20080427/locau804270386. 156 indiana health law review [vol. 8:141 treatment and prevention of substance abuse. specifically, this classifica­ tion is uniquely suited for addressing the issue of prenatal substance abuse, so long as the proper procedures are followed. b. civil commitment 1. indiana's civil commitment framework civil commitment is a process by which an individual can be detained in a mental health facility, usually for the individual's protection or for the protection of others, due to the individual's mental illness.81 the united states supreme court has held on more than one occasion that civil com­ mitment is "a significant deprivation of liberty that requires due process protection.'.s2 it is a practice which has long been employed in the united states for addressing the issues of the mentally ill.83 however, suffering from a mental disease alone will not result in the civil commitment of any indiana resident, nor would a finding of dangerousness alone be sufficient. 84 for an involuntary civil commitment proceeding to commence, it must be shown that an individual is mentally ill and either dangerous, or gravely disabled, as defined below.85 a. dangerous indiana defines "dangerous" as "a condition in which an individual as a result of mental illness, presents a substantial risk that the individual will harm the individual or others.'.s6 the interpretation or definition of "oth­ ers" within this defmition of "dangerous" is key. "others" would have to 81. black's law dictionary 202 (8th ed. 2005) (defining the term "civil commitment" as "a commitment of a person who is ill, incompetent, drug-addicted, or the like, as con­ trasted with a criminal sentence."). 82. see, e.g., addington v. texas. 441 u.s. 418,425 (1979). 83. see linden, supra note 3, at 121 ("involuntary hospitalization has been a part of mental health law in this country for a century and a halt:"). 84. kansas v. hendricks, 521 u.s. 346, 358 (1997) ("a finding of dangerousness, standing alone, is ordinarily not a sufficient ground upon which to justify indefinite involun­ tary commitment. we have sustained civil commitment statutes when they have coupled proof of dangerousness with the proof of some additional factor, such as a 'mental illness' or 'mental abnormality."'). 85. ind. code§ 12-26-1-1 (2007); see also cj. v. health and hosp. corp. of marion cnty., 842 n.e.2d 407,410 (ind. a. app. 2006) (noting that, in order to carry the burden of proof, an individual must be shown to be either dangerous or gravely disabled, both elements do not have to be proven). 86. ind. code § 12-7-2-53 (2009) {emphasis added); see also black's law dictionary 336 (8th ed. 2005) (defining the term "imminently dangerous" as "reasonably certain to place life and limb in peril"; explaining that, in a certain legal context, "if a mental condition renders a person imminently dangerous to self or others, he or she may be commit­ ted to a mental hospital."). 2011] treating addiction as ament al disease 157 be statutorily interpreted or defined to include the unborn fetus of a preg­ nant substance abuser. it should also be noted that within the statute, the term "harm" is also undefined. application of this statute within the framework of civil commitment would require acceptance that illegal drug use by a pregnant woman actually results in negative effects ("harm") on the unborn fetus ("other"). 87 further, "a trial court is not required to wait until harm has nearly or actually occurred before determining that an indi­ vidual poses a substantial risk of harm to others:.ss for the issue of prena­ tal substance abuse, this means that governmental intervention would not be dependent upon tangible evidence showing that the child has been harmed, such as a post-birth positive drug screen. b. gravely disabled "gravely disabled", is defined by statute as: [a] condition in which an individual, as a result of mental illness, is in danger of coming to harm because the individual: (1) is unable to provide for that indi­ vidual's food, clothing, shelter, or other essential hu­ man needs, or (2) has a substantial impairment or an obvious deterioration of that individual's judgment, reasoning, or behavior that results in the individual's inability to function independently. 89 while individuals in indiana have been deemed "gravely disabled"90 for conditions ranging from diabetes to the failure to take prescribed medica­ tions,91 the focus of this analysis is not on "gravely disabled." alternative87. see alexander scherr, daubert & danger: the "fit" of expert predictions in civil commitments, 55 hastings l.j. l, 53-54 (2003) (surveying various statutory approach­ es to the term "harm"); see also black's law dictionary 595 (8th ed. 2005) (defining "harm" as "[i]njury, loss, damage; material or tangible detriment."); see also harris & pal­ trow, supra note 26 ("health care personnel may hear contradictory information about the effects of prenatal drug exposure or appropriate responses to addiction."). 88. c.j., 842 n.e.2d at 410; see also matter of commitment of gerke, 696 n.e.2d 416, 421 (ind. ct. app. 1998) (holding, "we disagree with [the] implication ... that a com­ mitment premised upon a trial court's prediction of dangerous future behavior, without prior evidence of the predicted conduct, must be, in all cases, invalid. the old adage of "the dog gets one bite" does not, and should not, apply in the context of commitment proceedings, despite the severe restrictions on liberty imposed by commitment to a mental facility. "). 89. ind. code§ 12-7-2-96 (2009). 90. in recommitment of a.w.d., 861 n.e.2d 1260, 1265 (ind. ct. app. 2007) ("the evidence demonstrated a.w.d. is diabetic, requires two finger-prick tests of his blood sugar levels per day, and is unable to perform the tests on himself."). 91. in re commitment of bradbury, 845 n.e.2d 1063, 1065 (ind. ct. app. 2006) (where psychiatrist testified that bradbury's failure to take prescribed medication resulted in symptoms such as "disorganized, aggressive, agitated, and delusional behavior."). 158 indiana health law review [vol. 8:141 ly, this analysis demonstrates that women who use illegal drugs during pregnancy are mentally ill and dangerous. therefore, when women are found to be using drugs during pregnancy, an involuntary commitment pro­ ceeding is proper and justified under the statute. c. procedure the thrust of this analysis is that, if addiction is a mental illness, and use of illegal drugs during pregnancy by women is deemed to constitute a "substantial risk"92 of harm to "others "93 in conformance with the above ' statutory definitions, it should be a logical and effective preventive measure to pursue the civil commitment of pregnant women who are abusing drugs. a framework for the civil commitment of those with mental illness is al­ ready in place in indiana statute. section 12-26-1-l of the indiana code provides that an individual who is mentally ill and dangerous may be invol­ untarily detained or committed under one of four different procedures: im­ mediate detention, emergency detention, temporary commitment, and regular commitment.94 immediate detention is focused on giving law enforcement officers, who have reasonable grounds to believe an individual is mentally ill, dan­ gerous, and in need of hospitalization and treatment, the ability to appre­ hend and transport individuals to the nearest appropriate facility.95 the next option, emergency detention, require~ two statements: a statement by an applicant stating their belief that the individual in question is mentally ill, is either dangerous or gravely disabled, and is in need of immediate restraint; and another by at least one physician, based on an examination or an as­ sessment of information given to the physician, that the individual in ques­ tion is mentally ill, and either dangerous or gravely disabled. 96 the detention of an individual under the emergency detention procedure is lim­ ited to seventy-two hours.97 if the emergency detention is deemed valid, the result is usually an order for either a temporary commitment or a regular commitment of the individual; procedures are discussed below. temporary commitment allows a person to be committed who is al­ leged to be mentally ill, and either dangerous or gravely disabled, for a pe­ riod of not more than ninety days. 98 a regular commitment, ''the most restrictive form of involuntary treatment,'o99 applies to individuals alleged to 92. ind. code§ 12-7-2-53 (2009). 93. id. 94. ind. code § 12-26-1-1 {2009). 95. ind. code§ 12-26-4-1 {2009). 96. ind. code§ 12-26-5-l (2009). 97. !d. 98. ind. code § 12-26-6-1 (2009). 99. j.s. v. center for behavioral health, 846 n.e.2d 1106, 1111 (ind. ct. app., 2006) (quoting in recommitment ofr.l., 666 n.e.2d 929, 930 n.3 (ind. ct. app., 1996)). 2011] treating addiction as a mental disease 159 be mentally ill, and either dangerous or gravely disabled, and ''whose com­ mitment is reasonably expected to require custody, care, or treatment in a facility for more than ninety (90) days."100 the immediate detention procedure, because its duration would not cover the full term of the pregnancy, would likely have limited applicability to the issue here, although there are certain unique instances where the stat­ ute could be applied to prenatal substance abuse. in contrast, the emergen­ cy detention procedure could conceivably be the main route to the civil commitment of prenatal substance abusers. however, this option assumes that someone close to the pregnant drug abuser would cross the line from gently suggesting an end to the substance abuse, to forcing the pregnant drug user to receive help, in the best interest of the fetus. typically only a close friend or family member would know enough about the woman's sit­ uation to be able to provide meaningful information to those in a position to act. for example, in the case of in recommitment of j.b., the applicant requesting j.b.'s emergency detention was a deacon in j.b.'s church who knew about his bipolar disorder and with whom j.b. had a disturbing con­ versation where he expressed a desire to kill something and hit his ex­ wife.101 however, there is no doubt that there would be feelings of betrayal at such a move by a close friend or family member, especially in a situation as personal as pregnancy. furthermore, reliance on civil commitment to help stop the use of illegal drugs by pregnant women may not be ideal, but it is an option, and it would be a start. temporary and regular commitments would most likely become the standard for prenatal substance abusers. the procedures for temporary and regular commitments are similar to the procedure for emergency deten­ tions.102 for both temporary and regular commitments, the original petition must be paired with a statement from a physician attesting to the mental illness and either the dangerousness or grave disability of the individual.103 however, it should be noted that for regular commitments, the physician's statement must be based on an actual examination of the individual within thirty days prior to submission of the statement.104 for a temporary com­ mitment, the decision is left to the court hearing the proceedings as to whether or not to appoint a physician to examine the individual. 105 a hearing must be held under both procedures, 106 and it is left to the court to make the determination of the individual's mental illness and a 100. ind. code§ 12-26-7-1 (2009). 101. in recommitment ofj.b., 766 n.e.2d 795,796 (ind. ct. app., 2002). 102. see ind. code§ 12-26-5-1 (2009). 103. ind. code§ 12-26-6-2(c) (2009); ind. code§ 12-26-7-3 (2009). 104. ind. code§ 12-26-7-3(a)(2009). 105. ind. code§ 12-26-6-6 (2009). 106. ind. code§ 12-26-6-4; ind. code§ 12-26-7-4 (2009). 160 indiana health law review [vol. 8:141 finding of dangerousness to the individual or others. 107 the burden is on the state in these proceedings to show by clear and convincing evidence that the facts warrant commitment. 108 the "clear and convincing evidence" standard can only be met by a showing that the person's alleged dangerous behavior would not occur but for the person's mental illness.109 for a regu­ lar commitment to terminate, further action is required. such a commitment must be continuous until either the holding facility discharges the individual or the court enters an order terminating the commitment.110 therefore, the type of commitment required in a situation involving prenatal substance abuse would have to be determined by the court, most likely based on the gestational progress of the drug abuser's pregnancy. 2. civil commitment in other states the standards and procedures for civil commitment vary among the states. 111 many states have statutes similar to indiana law, while a few states take the reach of governmental intervention even farther. minnesota, new jersey, south dakota, and wisconsin all have statutes which provide for civil commitment and involuntary detention of mothers found to be ac­ tively using illegal drugs while pregnant.112 furthermore, two other states, north dakota and oklahoma, have statutes authorizing the civil commit­ ment of women who abuse alcohol during pregnancy.113 107. ind. code§ 12-26-6-8; ind. code§ 12-26-7-5 (2009). 108. in returner, 439 n.e.2d 201, 204 (ind. ct. app. 1982); see addington v. texas, 441 u.s. 418, 432-33, (1979) (finding that instruction used in texas proceeding for com­ mitment due to mental illness employing the standard of "clear, unequivocal, and convinc­ ing" evidence, was constitutionally adequate, but that the "determination of the precise burden equal to or greater than the 'clear and convincing' standard which we hold is required to meet due process guarantees is a matter of state law"). 109. g.q. v. branam, 917 n.e.2d 703, 707 (ind. ct. app. 2009). 110. § 12-26-7-5(b). 111. addington, 441 u.s. at 431 (noting that "[a]s the substantive standards for civil commitment may vary from state to state, procedures must be allowed to vary so long as they meet the constitutional minimum."); see also kansas v. hendricks, 521 u.s. 346, 359 (1997) ("[w]e have never required state legislatures to adopt any particular nomenclature in drafting civil commitment statutes."). 112. see minn. stat. ann. § 253b.05 (west 2007) (emergency admissions); minn. stat. ann.§ 626.5561 (west 2009) (reporting of prenatal exposure to controlled substanc­ es); § 626.5562 (toxicology tests required); see also n.j. stat. ann. § 30:4c-ll (west 2008) (application for care or custody, verification and investigation, and acceptance of care or custody); see also s.d. codified laws§ 34-20a-63 (2009) (emergency commitment and grounds); s.d. codified laws § 34-20a-70 (2009) (petition for involuntary commitment, appointment of attorney for applicant, procedure, and grounds); see also wis. stat.§ 48.133 (2008) (jurisdiction over unborn children in need of protection or services and the expectant mothers of those unborn children); wis. stat. § 48.193 (2008) (taking an adult expectant mother into custody); § 48.19(l)(cm) (taking a minor expectant mother into custody); § 48.205(lm) (criteria for holding a child or expectant mother in physical custody); § 48.205(l)(d) (criteria for taking pregnant minor into custody). 113. pregnancy and alcohol: civil commitment: policy description, national 2011] treating addiction as a mental disease 161 the procedure in wisconsin, as perhaps the first state to use civil commitment in the effort to curtail exposure to illegal substances, is par­ ticularly interesting and detailed. its three-stage approach proceeds through the rights and requirements involved in the initial taking of an individual into custody, to the brief holding of an individual in physical custody, to the continued physical custody of an individual. 114 as different as the proce­ dures in these states might be, "all of these commitment and custody provi­ sions are designed to protect the fetus via the involuntary restriction of the pregnant woman's action or conduct."115 but the farthest reaching statute to address the issue is a south carolina statute, under which the use of illegal drugs while pregnant can be prosecuted as a felony. 116 3. legislative will and public policy a. recent indiana legislation the indiana general assembly seems to be open to passing legislation that extends the protection of unborn children in the state, in both civil and criminal terms. effective july 1, 2009, the indiana wrongful death statute was amended to include the phrase, "a fetus that has attained viability," in the defmition of "child."117 the amendment was enacted with this new in­ clusion in direct response to a 2009 indiana appellate court decision. in institute on alcohol abuse and alcohousm, http://www.a1coholpolicy.niaaa.nih.gov/ alcohol_and_pregnancy_civil_commitment.html (last visited jan. 2, 2011) ("as ofjanuary i, 2008, five jurisdictions have statutory authorization for the civil commitment of women who abuse alcohol during pregnancy: minnesota, north dakota, oldahoma, south dakota, and wisconsin."). 114. id. ("wisconsin's child welfare laws provide for involuntary civil commitment to a variety of placements including a treatment facility, jail, and a relative's home. in wiscon­ sin there are three stages leading to a judicial commitment. in the first stage, a woman is taken into protective custody, usually by law enforcement or child protective services. in the second stage, in cases in which there is a substantial health risk to the fetus, the woman may be held (detained) in protective custody for up to 48 hours. in the third stage, if custody is sought for a sustained period of time (i.e., a period longer than provided for in the second stage), the woman is entitled to legal representation and a hearing at which a court deter­ mines whether it will enter an order for her continued custody. "). 115. id. 116. s.c. code ann. §16-3-85 (2008); see also karel, supra note 35 ("although the south carolina law could be applied to women who test positive for alcohol or tobacco, prosecutors there have limited application to women who test positive for illicit drugs, in­ cluding cocaine and marijuana"). 117. ind. code § 34-23-2-1 (2007); see also black's law dictionary 197 (8th ed. 2005) (defining "child" as "1. a person under the age of majority. 2.; hist. at common law, a person who has not reached the age of 14. 3.; a boy or girl; a young person. 4.; a son or daughter. 5.; a baby or fetus." (emphasis added); it is interesting to note that "a fetus that has attained viability'' would, quite literally, satisfy all of these definitions); see also harris & paltrow, supra note 26 (noting that expanded civil wrongful death statutes "hold only third parties accountable for causing pregnancy loss. courts have declined to extend these laws to pregnant women, recognizing that pregnant women's actions with respect to their own bodies raise different legal and policy issues"). 162 indiana health law review [vol. 8:141 ramirez v. wilson, a woman nine months pregnant was killed in a head-on car collision, and the baby died in uteroy8 the court held that a full-term, viable unborn fetus was not a "child" for purpose of the wrongful death statute.119 the statute was amended to thwart the ramirez court's interpre­ tation of the statute. another recent change in indiana law was the amend­ ment to the crime of murder, which now includes the charge that "[a] person who knowingly or intentionally kills a fetus that has attained viabil­ ity commits murder."12° further, the indiana feticide statute, which allows criminal prosecution for a person who "knowingly or intentionally termi­ nates a human pregnancy with an intention other than to produce a live birth or to remove a dead fetus," was also amended in 2009, increasing the max­ imum punishment from eight years to twenty years.121 these changes in indiana criminal law were direct results of a tragic event in 2008, when a bank teller who was five months pregnant with twins lost both fetuses after she was shot in the abdomen during a bank robbery.122 the bank robber was sentenced to fifty-three years, eight years of which stemmed from two feticide convictions.123 the willingness to change the law in indiana, within both the civil and criminal contexts, is most welcome because one of the loftiest goals a state can strive for is the protection of those who cannot pro­ tect themselves, especially protection for unborn children. b. public policy and the united states supreme court it would seem that this author's interpretations and opinions on the is­ sue are, in some ways, in agreement with the united states supreme court's interpretation: "[t]he state does have an important and legitimate interest in preserving and protecting the health of the pregnant woman ... it has still another important and legitimate interest in protecting the potenti­ ality of human life."124 it should be noted that even though the court in roe v. wade concluded that a fetus is not a ''person" and therefore does not en118. ramirez v. wilson, 901 n.e.2d 1, 2 (ind. ct. app. 2009). 119. id at 3. 120. ind. code§ 35-42-1-1 (2009). 121. ind. code § 35-42-1-6 (2009) (note that this law does not apply to an abortion performed in compliance with indiana law). 122. see rick callahan, bid made to add fetuses to murder law, news sentinel (may 1, 2008}, http://www.newssentinel.com/apps/pbcs.dlllarticle?aid=/sei 20080501/news/805010327; see also abcnews.com, man gets prison for shooting pregnant bank teller, feb. 13, 2010. http://abcnews.go.com/us/ wirestory? id= 9828628&page=1. 123. see abc news.com, supra note 122. 124. roe v. wade, 410 u.s. 113, 162 (1973); but see april l. cherry, roe's legacy: the nonconsensual medical treatment of pregnant women and implications for female citizenship, 6 u. pa. j. const. l. 723, 724 (2004) (arguing that the court's recognition in roe v. wade of a "compelling state interest" in fetal life has "in some ways led to the dero­ gation of women's choices, women's autonomy, and, consequently, women's citizenship"). 2011] treating addiction as a mental disease 163 joy any constitutional rights under the fourteenth amendment,125 it did rec­ ognize that fetuses may enjoy protection from other, non-constitutional sources. 126 moreover, [t]he state has a legitimate interest under its parens patriae powers in providing care to its citizens who are unable because of emotional disorders to care for themselves; the state also has authority under its po­ lice power to protect the community from the danger­ ous tendencies of some who are mentally ill. 127 further, "[t]he state may take measures to restrict the freedom of the dan­ gerously mentally ill. this is a legitimate non-punitive governmental objec­ tive and has been historically so regarded!'128 it is with such statements of policy and constitutional support from our nation's highest judicial authori­ ty, and the apparent willingness of the indiana general assembly to enact change, that the following recommendation for action concerning the issue of prenatal substance abuse is presented. iv. solution presented a. application of existing law indiana needs to apply existing statutes to the issue of prenatal sub­ stance abuse, expanding and refining the civil commitment response with­ out the need for criminal prosecution. chemical addiction, under indiana law, can and should be treated as a mental illness.129 in the state of indiana, those who suffer from mental illness and are found to be a danger to them­ selves or others, can be committed to the appropriate facility for treat­ ment. 130 such action is narrowly tailored and serves a compelling state interest.131 in kansas v. hendricks, the supreme court noted, "we have consistently upheld such involuntary commitment statutes provided the confinement takes place pursuant to proper procedures and evidentiary 125. roe, 410 u.s. at 158. 126. ld. at 162 (commenting that .. unborn children have been recognized as acquiring rights or interests by way of inheritance or other devolutions of property''). 127. addington v. texas, 441 u.s. 418,426 (1979). 128. kansas v. hendricks, 521 u.s. 346,363 (1997). 129. see ind. code§ 12-7-2-130 (2007). 130. ind. code§ 12-26-1-1 (2009). 131. see generally zablocki v. redhail, 434 u.s. 374, 388 (1978) ("when a statutory classification significantly interferes with the exercise of a fundamental right, it cannot be upheld unless it is supported by sufficiently important state interests and is closely tailored to effectuate only those interests."). 164 indiana health law review [vol. 8:141 standards. it thus cannot be said that the involuntary civil confinement of a limited subclass of dangerous persons is contrary to our understanding of ordered liberty."132 not only would civil commitment of pregnant substance abusers pro­ vide them with treatment throughout the pregnancy, but it could also pro­ vide detoxification in a facility with proper medical supervision to minimize the risk to the unborn fetus. the goal would not be long-term civil commitment, but rather a commitment which places the mother-to-be and the child in the best position to succeed in life together: one free from the oppressive existence that is drug addiction, the other free from exposure to illegal drugs during gestation. civil commitment offers a better solution to the problem of substance abuse during pregnancy because it "directly addresses the problem, lacks punitive aspects, and offers a potentially effec­ tive and long-term solution to gestational substance abuse."133 b. clarification and expansion of existing law clarification and expansion of current statutes could be as simple as an amendment which states that "others," for purposes of the definition of "dangerous" under section 12-7-2-53 ofthe indiana code, includes "a fetus that has attained viability," similar to the way the indiana wrongful death statute was recently amended.134 facilities to house individuals during treatment and postpartum already exist, but the "red tape" which impedes access to these facilities could be substantially reduced through direct civil commitment.135 the 2009 prenatal substance abuse commission report indicated there are underutilized residential facilities in the state.136 when underutilization of resources is combined with the estimates that the costs of lifetime care for children who are born after surviving prenatal exposure to alcohol or illegal drugs range from $750,000 to $1.4 million, the mone­ tary incentive for this solution speaks for itself.137 where appropriate treatment facilities are not available in an individual's community, indi­ ana's five psychiatric hospitals that accept adult patients could be ideal, es­ pecially the richmond state hospital's large substance abuse services 132. hendricks, 521 u.s. at 357; see also j.s. v. ctr. for behavioral health, 846 n.e.2d 1106, 1114 (ind. ct app., 2006) (''the indiana statutory scheme providing for judicial re­ view of a proposed treatment plan when a patient objects to the course of treatment is consti­ tutionally sufficient to satisfy the due process requirement of a judicial hearing by an independent decision maker to evaluate the competing interests reflected.''). 133. kristen rachelle lichtenberg, comment, gestational substance abuse: a call for a thoughtful legislative response, 65 wash. l. rev. 377,378 (1990). 134. ind. code§ 34-23-2-1 (2009). 135. see ind. prenatal substance abuse comm'n, supra note 1, at 11. 136. /d.; see also zollinger. et al., supra note 3, 186-234 (listing an inventory of treatment programs in indiana by county, with the type of services provided and contact information for each program). 137. kalotra, supra note 74. 2011] treating addiction as a mental disease 165 unit.138 further, indiana could facilitate priority access to state-funded sub­ stance abuse treatment programs for pregnant women, as has been done in nine other states, and prohibit publicly-funded treatment facilities from dis­ criminating against pregnant women, as four other states have done.139 c. a possibility for future legislative action and response to opposing viewpoints 1. for consideration: a point of agreement with the prenatal substance abuse commission final report a possibility for the indiana general assembly to consider is a uni­ form screening procedure for all pregnant women in indiana to determine levels of illegal drug use, similar to one of the recommendations of the pre­ natal substance abuse commission.140 the idea behind a uniform screening procedure is to ensure that those women who do seek out medical supervi­ sion during their pregnancies are at least asked the questions regarding pos­ sible alcohol, tobacco, or illegal drug use. a uniform screening procedure would not necessarily need to become state law, however, providing mini­ mal funding might help to persuade prenatal medical providers to utilize a question-and-answer verbal process with their clients. one would hope that doctors are not simply assuming a pregnant woman is not using alcohol, tobacco, or illegal drugs unless they are informed otherwise. one indiana non-profit agency, the indiana perinatal network, has already developed a dvd-based training aid for physicians, which focuses on integrating screening and treatment of alcohol, tobacco, and illegal drug use into rou­ tine prenatal care.141 after women are questioned about any alcohol, tobac­ co, or illegal drug use, any self-reported use could be addressed immediately and discretely, hopefully within the confines of the doctor­ patient relationship and without the need for judicial intervention. howev­ er, if that is not possible, civil commitment could become an option. 138. richmond state hosp., facility fact sheet, indiana family and social services administration: division of mental health & addiction, http://www.in.gov/ fssa/dmha/files!rsh_fact_sheet_09.pdf(last visited jan. 2, 2011) (''the recovery philosophy of the program is based on a recovery model of dependency as a disease with special atten­ tion to the stages of change."). 139. the guitmacher inst., state policies in brief: substance abuse during pregnancy 1 (2010), available at http://www.guttmacher.org/statecenter/spibs/ spib_sadp.pdf; see also zollinger, et al.,supra note 3, at 6 ("[m]any [indiana] programs are not accessible to pregnant women especially if they have other children and/or need inpa­ tient care."). 140. ind. prenatal substance abuse comm'n, supra note 1, at 5. 141. substance use, indiana perinatal network, http://www.indianaperinatal.org/ sections/substance_ use.php (last visited jan. 2, 2011 ). 166 indiana health law review [vol. 8:141 2. opposing viewpoints the most common argument against is the above proposal is: wouldn't this type of system discourage a pregnant woman even more from pursuing medical attention if there is a chance she will have a positive urine screen, or other indicator, which could lead to a temporary period of com­ mitment? obviously, this is a strong possibility, especially with pregnant women who already have other children as well. there are several chal­ lenges that would be involved in correctly identifying women for whom the application of the civil commitment framework, or even voluntary treat­ ment, would be appropriate. 142 this opposition argument was succinctly summarized by the american civil liberties union: a decade ago, we saw a rash of cases in which gov­ ernment officials zealously embraced a misguided mission to protect fetuses by attempting to control the conduct of pregnant women. some women were forced to accept unwanted medical treatment; others were punished for their conduct during pregnancy. inevitably, such actions backfire: women who fear the government's "pregnancy police" will avoid prenatal care altogether, and both they and their fetuses will suffer as a result.143 however, the solution proposed here is not presented as a cure-all for the issue of prenatal substance abuse. rather, it is presented as an option, which in some ways is already available in indiana. if it is successful in preventing even one unborn fetus from being exposed to the crippling ef­ fects of illegal substances, it will have done some good. the interests of the mother would also be served, especially in those instances where the drug abuser truly wants to address her addictions. in the current approach, the courts usually become involved only after a mother gives birth to a child who tests positive for illegal drugs, 144 the result of which would almost in142. see zollinger, et al., supra note 3 ("one of the most difficult challenges of ... treatment is identifying women using [alcohol, tobacco, or illegal drugs] and drawing them into care."). 143. coercive and punitive governmental responses to women's conduct during pregnancy, american civil liberties union (sept. 30, 1997), http://www.aclu.org/ repro­ ductive-freedom/coercive-and-punitive-governmental-responses-womens-conduct-during­ pregnancy; see also karel, supra note 35 ("legal threats against pregnant women with drug problems cause them to avoid prenatal care for fear of detection, which means that the risk to mother and fetus from drug use is compounded by an absence of prenatal care."). but see linden, supra note 3, at 110 (discussing how ''both criminal and tort law have moved in the direction of recognizing fetal interests"). 144. see ind. code§ 31-33-5-4 (2008). 2011] treating addiction as amentaldisease 167 variably lead to the termination of parental rights. 145 the solution presented here would be an opportunity for the mother to address her addiction prior to the birth of her child, perhaps presenting an opportunity for the mother and child to remain together after the birth in a way that would not be likely to occur under the current legal framework. 146 neither criminalization nor the use of child protection laws adequately promotes both healthy births and the preservation of the mother-child relationship.147 next is the question: wouldn't this put a medical professional in an adversarial role to the patient? this view is understandable, and the dilem­ ma has certainly been . noted by medical professionals contemplating the possible moral, ethical, and legal considerations.148 however, as a positive, it would put the medical professional in an advocate role for the unborn child. 149 further, many states already statutorily require medical profes­ sionals to report suspected prenatal substance abuse. 150 indiana could im­ plement a similar statutory requirement. critics of commitment look to medical professionals for support of their perspective. for example, "leading medical and public health groups-such as the american academy of pediatrics, the american medi­ cal association, the american public health association and the march of dimes-all oppose punitive responses to prenatal drug use,"151 including 145. see ind. code§ 31-33-7-4(2008). 146. see david f. chavkin, "for their own good": civil commitment of alcohol and drug-dependent pregnant women, 37 s.d. l. rev. 224, 248-49 (1992) ("[r]esearch on mandatory treatment programs indicates that such treatment can be effective. the signifi­ cant factor appears to be not the voluntary or mandatory nature of the treatment, but rather the characteristics of the treatment provided, whatever the impetus to seek care."); see also wendy chavkin, help, don't jail, addicted mothers, n.y. times, july 18, 1989, at a21 (where the author reports, "most pregnant women, including addicted ones, want very much to do what's right for their future children. at a drug treatment program in new york city, 30 addicted women told me that they felt so guilty about using drugs while pregnant that they used more drugs to escape the feelings of self-loathing."). 147. linden, supra note 3, at 120. 148. see harris & paltrow, supra note 26, at 1698 (''civil commitment laws and civil child welfare laws addressing the subject of drug use during pregnancy may intensify confu­ sion regarding physicians' legal obligations."). 149. see generally id. ("some bioethical models assert that physicians have moral obli­ gations to fetal 'patients,' separate from obligations to pregnant women. these models may imply that fetuses have a right to medical attention independent of pregnant women's con­ sent."); see also linden, supra note 3, at 115 (explaining that under the theory of "cultural feminism," "society must not adopt adversarial approaches which view the mother and fetus as distinct legal entities with adverse interests and assume that the state must protect the fetus from the mother."). 150. the gutimacher inst., supra note 139 (current states requiring reporting do not include indiana); see also karel, supra note 35 ("mandatory reporting approaches are prob­ lematic because they place the physician in an awkward position regarding the doctor-patient relationship and because they tend to [drive away] people who don't want to be subjected to reporting"; "good health care demands trust. between the doctor and the patient."). 151. dailard & nash, supra note 58, at 6; see also karel, supra note 35 (''use of crimi­ nal sanctions for women who use drugs during pregnancy has been rejected by most public health organizations"). 168 indiana health law review [vol. 8:141 civil commitment and criminal sanctions. however, rarely is it the judicial practice to equate civil commitment to a criminal sanction. civil commit­ ment is defined as a "commitment of a person who is ill, incompetent, drug­ addicted, or the like, as contrasted with a criminal sentence."152 indeed, the united states supreme court has held, "in a civil commitment state power is not exercised in a punitive sense .... a civil commitment proceeding can in no sense be equated to a criminal prosecution,"153 as well as stating that "the mere fact that a person is detained does not inexorably lead to the con­ clusion that the government has imposed punishment."154 however, with regard to commitment in general, a key point is made that should be kept in mind, but which may become less of a concern as society begins to under­ stand and accept the proposition that those suffering from addiction are ac­ tually suffering from a form of mental illness: [i]t is indisputable that involuntary commitment to a mental hospital after a finding of probable dangerous­ ness to self or others can engender adverse social con­ sequences to the individual. whether we label this phenomena "stigma' or choose to call it something else is less important than that we recognize that it can occur and that it can have a very significant im­ pact on the individual.155 indiana courts have reflected this sentiment, stating, "the question of how persons subject to involuntary commitment are treated by our trial courts is one of great importance to society. indiana statutory and case law affirm that the value and dignity of the individual facing commitment or treatment is of great societal concem."156 in the implementation of the solution pre­ sented here, these concerns must be kept in mind. v. conclusion indiana's current approach to the problem of illegal drug use during pregnancy does not acknowledge the increasingly validated assertion that addiction is a mental illness. with the status-quo approach, most recently recommended by the indiana general assembly's prenatal substance 152. black's law dictionary 202 (8th ed. 2005) (emphasis added). 153. addington v. texas, 441 u.s. 418, 428 (1979); see also kansas v. hendricks, 521 u.s. 346, 363 (1997) ("the court has, in fact, cited the confinement of 'mentally unstable individuals who present a danger to the public' as one classic example of nonpunitive deten­ tion." (citing united states v. salerno, 481 u.s. 739, 748-49 (1987)). 154. salerno, 481 u.s. at 746. 155. addington, 441 u.s. at 425-26. 156. in recommitment of j.b., 766 n.e.2d 795,798 (ind. ct. app., 2002). 2011] treating addiction as a mental disease 169 abuse commission, of raising awareness and focusing on prevention and treatment, the state of indiana fails to use all its resources to prevent prena­ tal exposure to illegal drugs. while a continued focus on prevention and treatment for pregnant substance abusers is at least an attempt to mitigate the issue, and by all means the most common governmental approach, fail­ ure to exercise judicial intervention in appropriate circumstances is a grave disservice to the unborn fetuses that are being affected by the horrors of prenatal substance abuse. the state of indiana should be bold in its approach to the issue of pre­ natal substance abuse, following in the footsteps of several other midwest­ em states. the continued failure by the state of indiana to utilize all available resources leaves it open to a potentially highly publicized instance of prenatal illegal substance exposure, which would result in a public back­ lash causing a kneejerk reaction by the legislature to enact more drastic leg­ islation. the approach outlined above, which lays out the groundwork and procedure by which certain women who are found to be pregnant and cur­ rently addicted to drugs can be committed to an appropriate residential treatment provider, should be focused on the most serious of cases. addic­ tion is a mental illness, and should be treated as such. an addiction which affects an unborn fetus is a circumstance where the pregnant user is both mentally ill and dangerous to the point of presenting a substantial risk to others, specifically the unborn fetus. this proposed approach is a narrowly tailored governmental intervention which serves a compelling state interest in the protection of viable unborn fetuses, without the challenges and adver­ sity which would result from criminal sanctions. microsoft word final for lulu vol. 14 issue 1 final a. the burden of untreated pain. the importance of opioid therapy potential pitfalls of opioid therapy the burden of untreated opioid addiction medication assisted treatment federal regulation of mat: historical context federal regulation of methadone federal regulation of buprenorphine insurance coverage of mat access to emergency overdose treatment addressing legal and policy barriers to naloxone access 1. immunity 2. prescribing outside of the traditional prescriber relationship 3. overdose good samaritan laws 4. over-the-counter access http://doi.org/10.18060/3911.0027 a. the burden of untreated pain prevalence of chronic benign pain disorder among adults: a review of the literature common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders https://doi.org/10.1016/s0304-3959(98)00117-1 https://doi.org/10.1016/j.jpain.2008.05.005 supra aapm facts and figures on pain back pain prevalence and visit rates: estimates from u.s. national surveys, 2002 supra supra access to therapeutic opioids: a plan of action for donors, ngos, and governments persistent postsurgical pain: risk factors and prevention depression and anxiety associated with three pain conditions: results from a nationally representative sample cancer-related chronic pain: examining quality of life in diverse cancer survivors the economic costs of pain in the united states a systematic review of low back pain cost of illness studies in the united states and internationally aging baby boomers and the rising cost of chronic back pain: ssecular trend analysis of longitudinal medical expenditures panel survey data for years 2000 https://doi.org/10.1097/01.brs.0000244618.06877.cd https://doi.org/10.1016/s0140-6736(06)68700-x https://doi.org/10.1016/j.pain.2004.06.002 https://doi.org/10.1002/cncr.25761 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treatment as a human right http://doi.org/10.1055/s-0033-1351138 https://doi.org/10.1016/j.pmn.2007.11.002 https://doi.org/10.1016/s1470-2045(12)70040-2 https://doi.org/10.1093/annonc/mdm056 https://doi.org/10.1016/j.jana.2012.05.006 https://doi.org/10.1186/1741-7015-8-8 c. potential pitfalls of opioid therapy pain management: a fundamental human right monitoring opioid adherence in chronic pain patients: assessment of risk of substance misuse 2014 global consumption of oxycodone (mg/capita) id. id. the world health organization paves the way for action to free people from the shackles of pain management of pain in elderly patients with cancer. sage study group. systematic assessment of geriatric drug use via epidemiology time to take stock: a meta-analysis and systematic review of analgesic treatment disparities for pain in the united states https://doi.org/10.1213/01.ane.0000268145.52345.55 https://doi.org/10.1213/01.ane.0000267542.72315.34 http://doi.org/10.1001/jama.279.23.1877 https://doi.org/10.1111/j.1526-4637.2011.01310.x vital signs: overdoses of prescription opioid pain relievers–united states, 1999-2008 ambulatory diagnosis and treatment of nonmalignant pain in the united states, 2000-2010 rising opioid prescribing in adult u.s. emergency department visits: 2001-2010 opioids compared to placebo or other treatments for chronic lowback pain comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses opioid therapy for treating rheumatoid arthritis pain oral or transdermal opioids for osteoarthritis o f the knee or hip combining ibuprofen and acetaminophen for acute pain management after third-molar extractions: translating clinical research to dental practice https://doi.org/10.1097/mlr.0b013e3182a95d86 https://doi.org/10.1111/acem.12328 https://doi.org/10.1002/14651858.cd004959.pub4 https://doi.org/10.1016/j.spinee.2013.08.049 https://doi.org/10.1002/14651858.cd003113.pub3 https://doi.org/10.1002/14651858.cd003115.pub4 https://doi.org/10.14219/jada.archive.2013.0207 long-term opioid treatment of chronic nonmalignant pain: unproven efficacy and neglected safety? opioid pharmacotherapy for chronic non-cancer pain in the united states: a research guideline for developing an evidence-base long-term opioid management for chronic noncancer pain the effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a national institutes of health pathways to prevention workshop opioids for chronic noncancer pain: a position paper of the american academy of neurology supra opioid complications and side effects a comprehensive review of opioid-induced hyperalgesia https://doi.org/10.2147/jpr.s47182 https://doi.org/10.1016/j.jpain.2010.02.019 https://doi.org/10.1002/14651858.cd006605.pub2 https://doi.org/10.7326/m14-2559 https://doi.org/10.1212/wnl.0000000000000839 rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis societal costs of prescription opioid abuse, dependence, and misuse in the united states increases in drug and opioid overdose deaths — united states, 2000– 2014 id. association between opioid prescribing patterns and opioid overdose-related deaths relationship of opioid prescription sales and overdoses, north carolina supra number and age-adjusted rates of drugpoisoning deaths involving opioid analgesics and heroin: united states, 2000–2014 supra relationship between nonmedical prescription-opioid use and heroin use trends in long-term opioid therapy for chronic non-cancer pain see, e.g. pain management, controlled substances, and state medical board policy: a decade of change https://doi.org/10.1097/01.j.pain.0000460357.01998.f1 https://doi.org/10.1111/j.1526-4637.2011.01075.x https://doi.org/10.1001/jama.2011.370 https://doi.org/10.1016/j.drugalcdep.2013.01.006 https://doi.org/10.1056/nejmc1601875 http://doi.org/10.1002/pds.1833 https://doi.org/10.1016/s0885-3924(01)00403-1 the prescription opioid and heroin crisis: a public health approach to an epidemic of addiction see the promotion and marketing of oxycontin: commercial triumph, public health tragedy in guilty plea, oxycontin maker to pay $600 million form 10-q insys therapeutics, inc. judge halts counties' lawsuit against 5 narcotic drug manufacturers see physician continuing education to reduce opioid misuse, abuse, and overdose: many opportunities, few requirements https://doi.org/10.1146/annurev-publhealth-031914-122957 https://doi.org/10.2105/ajph.2007.131714 https://doi.org/10.1016/j.drugalcdep.2016.04.002 a. the burden of untreated opioid addiction physician continuing education to reduce opioid misuse, abuse, and overdose: many opportunities, few requirements societal costs of prescription opioid abuse, dependence, and misuse in the united states id. see, e.g., economic impact of opioid abuse, dependence, and misuse the economic burden of diagnosed opioid abuse among commercially insured individuals see the burden of undiagnosed opioid abuse among commercially insured individuals https://doi.org/10.1016/j.drugalcdep.2016.04.002 https://doi.org/10.1111/j.1526-4637.2011.01075.x https://doi.org/10.3810/pgm.2014.07.2783 https://doi.org/10.1111/pme.12768 b. medication assisted treatment (“mat”) emerging epidemic of hepatitis c virus infections among young nonurban persons who inject drugs in the united states 2006–2012 supra changes in substance abuse treatment use among individuals with opioid use disorders in the united states, 2004-2013 id. see, e.g., see generally https://doi.org/10.1093/cid/ciu643 https://doi.org/10.1001/jama.2015.10345 see also see also a comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence see also see medication-assisted treatment of opioid use disorder: review of the evidence and future directions supra see deaths during methadone maintenance methadone maintenance: the basics buprenorphine: a drug you need to know about https://doi.org/10.1056/nejm200011023431802 https://doi.org/10.1097/hrp.0000000000000075 https://doi.org/10.1097/01.eem.0000351378.22473.93 https://doi.org/10.1097/01.eem.0000345622.44884.91 https://doi.org/10.1097/01.eem.0000342736.85273.cb id. supra supra supra methadone maintenance: the basics supra medication-assisted therapies — tackling the opioid-overdose epidemic opioid agonist treatments and heroin overdose deaths in baltimore, maryland, 1995-2009 methadone maintenance and addicts’ risk of fatal heroin overdose the effectiveness of opioid maintenance treatment in prison settings: a systematic review https://doi.org/10.1056/nejmp1402780 https://doi.org/10.2105/ajph.2012.301049 https://doi.org/10.3109/10826089609045806 https://doi.org/10.1111/j.1360-0443.2011.03676.x c. federal legal regulation of mat: historical context adoption and implementation of medications in addiction treatment programs supra failure of physicians to prescribe pharmacotherapies for addiction: regulatory restrictions and physician resistance id. supra id. see from morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the united states https://doi.org/10.1097/adm.0b013e3181d41ddb https://doi.org/10.1016/s0376-8716(03)00055-3 journal of the american medical association a medical treatment for diacetylmorphine (heroin) addiction a clinical trial with methadone hydrochloride see understanding fda regulatory requirements for investigational new drug applications for sponsor-investigators supra supra id. supra supra not supra id. supra https://doi.org/10.1001/jama.1965.03090080008002 https://doi.org/10.2310/jim.0b013e3181afdb26 d. federal regulation of methadone supra id . supra supra supra supra see also supra supra supra prescriptions see ; id. id. id. id. see see id. see see id. program or practitioner see see id. see see see id. see id. id. id. id. id. id. id. id. id. id. id. id. e. federal regulation of buprenorphine id. buprenorphine: a drug you need to know about supra see id. id. id id. id. id. id. f. insurance coverage of mat id. id. id. id. see infra id. id. id. see equality standards for health insurance coverage: will the mental health parity and addiction equity act end the discrimination? see achieving real parity: increasing access to treatment for substance use disorders under the patient protection and affordable care act and the mental health and addiction equity act id. id. id. id. see amended by id. id. id. id. id the effects of federal parity on substance use disorder treatment access to mental health care increased but not for substance use, while disparities remain https://doi.org/10.1377/hlthaff.2016.0098 a. access to emergency overdose treatment supra management of common opioid-induced adverse effects drug makers stand firm on tv ad for opioid-induced constipation , strategies to manage the adverse effects of oral morphine: an evidence-based report mechanisms of fatal opioid overdose see opioids and the control of respiration physiological and pathological responses to hypoxia increases in drug and opioid overdose deaths–united states, 2000-2014 https://doi.org/10.1200/jco.2001.19.9.2542 https://doi.org/10.1046/j.1360-0443.1999.9479612.x https://doi.org/10.1093/bja/aen094 https://doi.org/10.1016/s0002-9440(10)63747-9 see a comprehensive review of naloxone for the emergency physician id. review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access see also controlled substances–alphabetical order assessment of the safety and ease of use of the naloxone autoinjector for the reversal of opioid overdose see also emergency medical services naloxone access: a national systematic legal review emergengy medical services naloxone access bologna-naloxone supplied to italian heroin addicts take home naloxone and the prevention of deaths from opiate overdose: two pilot schemes preliminary evidence of health care provider support for naloxone prescription as overdose fatality prevention strategy in new york city community-based opioid overdose prevention programs providing naloxone–united states, 2010 https://doi.org/10.1016/0735-6757(94)90033-7 https://doi.org/10.1177/2042098614564776 https://doi.org/10.2147/oaem.s82133 https://doi.org/10.1111/acem.12485 https://doi.org/10.1016/s0140-6736(05)61528-0 https://doi.org/10.1136/bmj.322.7291.895 http://doi.org/10.1093/jurban/jtg031 opioid overdose prevention programs providing naloxone to laypersons–united states, 2014 id. prescribe to prevent: overdose prevention and naloxone rescue kits for prescribers and pharmacists orienting patients to greater opioid safety: models of community pharmacy-based naloxone see also state legal innovations to encourage naloxone dispensing cdc guideline for prescribing opioids for chronic pain--united states, 2016 opioid overdose rates and implementation of overdose education and nasal naloxone distribution in massachusetts: interrupted time series analysis id. see also prescribing naloxone to actively injecting heroin users: a program to reduce heroin overdose deaths nonrandomized intervention study of naloxone coprescription for primary care patients receiving long-term opioid therapy for pain https://doi.org/10.1097/adm.0000000000000223 https://doi.org/10.1186/s12954-015-0058-x https://doi.org/10.1016/j.japh.2016.11.007 https://doi.org/10.1001/jama.2016.1464 https://doi.org/10.1136/bmj.f174 https://doi.org/10.1300/j069v25n03_11 https://doi.org/10.7326/m15-2771 b. addressing legal and policy barriers to naloxone access cost-effectiveness of distributing naloxone to heroin users for lay overdose reversal opioid overdose prevention and naloxone distribution in rhode island overdose rescues by trained and untrained participants and change in opioid use among substance-using participants in overdose education and naloxone distribution programs: a retrospective cohort study see prescribe physicians' knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities legal changes to increase access to naloxone for opioid overdose reversal in the united states https://doi.org/10.7326/0003-4819-158-1-201301010-00003 https://doi.org/10.1186/1471-2458-14-297 https://doi.org/10.1007/s11524-006-9120-z https://doi.org/10.1016/j.drugalcdep.2015.10.013 1. immunity for naloxone prescribing, dispensing, and administration changing law from barrier to facilitator of opioid overdose prevention legal aspects of providing naloxone to heroin users in the united states stopping an invisible epidemic: legal issues in the provision of naloxone to prevent opioid overdose stopping an invisible epidemic see also engaging law enforcement in overdose reversal initiatives: authorization and liability for naloxone administration physicians' perceptions of the risk of being sued physicians' fears of malpractice lawsuits are not assuaged by tort reforms https://doi.org/10.1111/jlme.12035 https://doi.org/10.1016/s0955-3959(01)00080-9 https://doi.org/10.2105/ajph.2015.302638 https://doi.org/10.1215/03616878-17-3-463 https://doi.org/10.1377/hlthaff.2010.0135 2. prescribing outside of the traditional prescriber relationship see see id. stopping an invisible epidemic supra see id. id. id. id. 3. overdose good samaritan laws see emergengy medical services naloxone access supra cost-effectiveness of pneumococcal and influenza vaccination standing order programs see also are standing order programs associated with influenza vaccination?–nnhs, 2004 id. luke colossians luke id. id. id . see is there a doctor (and a lawyer) in the house? why our good samaritan https://doi.org/10.1016/j.jamda.2009.12.091 4. over the counter access to naloxone laws are doing more harm than good for a national public health security strategy: a fiftystate survey see, e.g. ‘we can’t arrest our way out of it’: chesterfield police explore new ways to combat heroin epidemic see also upton: we can’t arrest our way out of opioid epidemic id. id. id. id. id. see "over the counter" naloxone access, explained see australia reschedules naloxone for opioid overdose see the availability of take-home naloxone in canada see guidance: widening the availability of naloxone take-home naloxone for opioid overdose in people who use drugs https://doi.org/10.5694/mja15.01181 see the fda and plan b: the legislative history of the durhamhumphrey amendments and the consideration of social harms in the rx-otc switch supra see also regulatory mechanisms for marketing otc drug products see also small business assistance: frequently asked questions on the regulatory process of over-the-counter (otc) drugs introduction to nonprescription products . id. overview of the over-the-counter drug monograph process see id. see otc naloxone? it's possible see you can buy insulin without a prescription, but should you? see generally changing the status of drugs from prescription to over-thecounter availability see supra see also regulation of nonprescription products, see supra see id. id. id. supra changing course: a new approach to opioid pain medication at fda epidemic: responding to america's prescription drug abuse crisis https://doi.org/10.1056/nejmra011080 overdose death rates increases in drug and opioid overdose deaths–united states, 20002014 what we know, and don't know, about the impact of state policy and systems-level interventions on prescription drug overdose state legal restrictions and prescription-opioid use among disabled adults drugpoisoning deaths involving heroin: united states, 2000-2013 see generally increases in drug and opioid overdose deaths–united states, 2000-2014 applying farr's law to project the drug overdose mortality epidemic in the united states effect of a "pill mill" law on opioid prescribing and utilization: the case of texas https://doi.org/10.1016/j.drugalcdep.2014.10.001 https://doi.org/10.1056/nejmsa1514387 https://doi.org/10.1016/j.drugalcdep.2015.12.025 see generally physician continuing education to reduce opioid misuse, abuse, and overdose: many opportunities, few requirements trends in methadone distribution for pain treatment, methadone diversion, and overdose deaths–united states, 2002-2014 see generally https://doi.org/10.1016/j.drugalcdep.2016.04.002 because of history, philosophy, the constitution, fairness & need: why americans have a right to national health care because of history, philosophy, the constitution, fairness & need: why americans have a right to national health care kenneth shuster* i. introduction .................................. 75 ii. a brief history of health care coverage in the united states .......................... 76 iii. a right to health care under the constitution. 85 iv. ways to provide access to national health care 93 v. arguments against national single-payer health care .................................... 97 vi. how a national health care program should be funded ................................... ..... 102 vii. philosophical issues and questions of fairness over national health care ... ............... 104 viii. conclusion ................................... 115 i. introduction this article examines the present state of health care in the united states, as well as the history of such care, and health insurance generally, and claims that access to health care is a right to which americans are entitled. it also looks to how national health care should be implemented.' such * the author, a rabbi and attorney, received his rabbinical ordination from the rabbi isaac elchanan theological seminary, an m.s. in jewish philosophy from yeshiva university, a j.d. from new york law school, and an ll.m. from nyu school of law. he is an expert in comparative talmudic and american law and jewish medical ethics, and has published numerous articles on talmudic and american law, and comparative talmudic and american law. the author thanks professor mark e. brandon, of the vanderbilt law school, for his assistance. this article is dedicated to gary n. lerner, m.d. 1 it may not initially be apparent in a paper devoted to finding a right to healthcare why we need to ask how such a right should be executed. however, as we will see, the major problem americans face when it comes to health care is not lack of health care insurance plans indiana health law review an examination is important, for according to the latest gallup poll, as of december 2011, close to 20% of americans over the age of twenty lack health insurance. 2 this lack of insurance, according to conservative estimates, costs united states' taxpayers, in the form of government programs, forty-two billion dollars a year.3 moreover, many insured americans are presently not able to pay all of their medical bills due to copayments, deductibles, and exorbitant medical costs. 4 to better appreciate why this reality exists i provide a brief history of health care and attempts at health care reform in the united states. ii. a brief history of health care coverage in the united states health insurance as we know it was first available in this country in the 1920s.5 before then, no attempt to exist in abundance but affordable access to health coverage. therefore, even if health care is found to be a legal right, the problem of the uninsured or underinsured can only be rectified by the manner and degree to which it is made available to americans. 2 jon walker, number of uninsured americans steadily increasing, fdl action (jan. 24, 2012, 8:58 am), http://fdlaction. firedoglake.com/2012/01/24/number-of-uninsured-americans-steadilyincreasing (last visited feb. 6, 2013). 3 the uninsured, aetna, https://wwwl.aetna.com/about-aetnainsurance/public-policy-perspectives/uninsured.html (last visited oct. 13, 2012) [hereinafter aetna]. 4 cathy schoen et al., how many are underinsured? trends among us. adults, 2003 and 2007, the commonwealth fund (june 10, 2008), http://www.commonwealthfund.org/publications/in-theliterature/2008/jun/how-many-are-underinsured--trends-among-u-s-adults--2003-and-2007.aspx (last visited oct. 13, 2012) (stating that in health care parlance, such individuals, who numbered 25 million in 2007, are underinsured); richard l. brandt, almost half of americans can't pay their medical bills., entrepreneur watch (march 12, 2010), http://richardbrandt.blogs.comlentrepreneurwatch/ 2010/03/almost-half-of-americans-cant-pay-their-medical-bills.html (last visited feb. 6, 2013). 5 melissa thomasson, health insurance in the united states, eh.net (feb. 1, 2010), http://eh.net/encyclopedialarticle/thomasson. insurance.health.us (last visited oct. 13, 2012). 76 vol. 10:1 2013 why americans have a right to national health care provide extended health coverage was successful.6 there are many reasons for this. first, before the 1920s, insurance companies saw no need to provide wide coverage because most individuals believed they did not require it.7 without a perceived need, and resultant profits, and the reality that applicants could lie about their health status, insurance companies viewed individual health coverage as an unacceptable financial risk.8 moreover, without the means to calculate health risks in individual circumstances, insurance companies could not accurately assess premiums.9 second, because society lacked many modern medical cures and technology,10 the need for health 6 brian palmer, obama says theodore roosevelt lobbied for health care reform . . . , slate magazine (march 9, 2010), http://www.slate.com/articles/news-and-politicslexplainer/2010/03/obam asays theodore rooseveltlobbiedforhealthcarereform_.html (last visited oct. 13, 2012) (asserting that attempts to provide expanded health care prior to the 1920s included lobbying by president theodore roosevelt during his 1912 "bull moose" campaign and proposals enacted by the american association for labor legislation); bill meyer, national health care debate goes back to theodore roosevelt plan in 1912: analysis, cleveland. com (aug. 12, 2009), http://www .cleveland.com/nation/index.ssf/2009/08/national health care debate ha .ht; thomasson, supra note 5, at 1 (noting that proposals by the american association for labor legislation were never enacted). 7 thomasson, supra note 5, at 1 (asserting that before 1920 most people did not feel they needed health insurance); stephanie kelton, an introduction to the health care crises in america: how did we get here., cfeps (sept. 2007), http://www.cfeps.org/health/chapters/ html/chl.htm (stating that there was no market for health insurance throughout the nineteenth century due to medical care being provided at home). 8 thomasson, supra note 5, at 1 (declaring that commercial insurance companies were unwilling to offer private health insurance); john t. preskitt, health care reimbursement: clemens to clinton, ncbi (jan. 2008), http://www.ncbi.nlm.nih.gov/pmc/articles/ pmc2190551/ (last visited feb. 6, 2013) (emphasizing that insurance companies were unwilling to insure due to inability to calculate health risks). 9 preskitt, supra note 8, at 40 (stating that insurance companies lacked the information to write premiums); thomasson, supra note 5, at 1 (stating that insurance companies felt they lacked the information to accurately write premiums). 10 for example, insulin and sulfa, used to treat diabetes, were not discovered until 1922 and 1935, respectively, penicillin was not 77 indiana health law review insurance prior to 1920 was not as important as it is today because the average american did not need to spend a lot on medical care.11 when they thought to have others pay their expenses, most individuals cared about sickness insurance and funeral costs, which many employers and insurance companies covered.12 thirdly, in addition to insurance companies, physicians and pharmacists opposed individual health insurance because they felt it would limit their fees and undermine their businesses.13 beginning in the 1920s, the health care landscape started to change. due to the progress in medical cures and technology (which were due in large part to increased machines and treatment modalities) that were more appropriate in hospital settings than residences, the locus of treatment shifted from homes to hospitals.14 moreover, many states started to require more extensive licensing and training requirements for doctors. 16 as a discovered until 1928, and large-scale production of penicillin did not happen until after world war ii, a vaccine for polio was not created until 1955, the iron-lung machine was not developed until 1928, and the electroencephalogram was first used in 1929. see thomasson, supra note 5, at table 1 (stating that insulin fashioned in 1922, sulfa developed in 1935, and the polio vaccine was discovered in 1955); tim lambert, a brief history of medicine, http://www .localhistories.org/medicine.html (last visited oct. 13, 2012) (noting that penicillin was discovered in 1928, electroencephalogram was first used in 1929, and the iron-lung machine was invented in 1928). 11 thomasson, supra note 5, at 1 (proclaiming that because of the rudimentary state of medical technology before 1920, people had low medical expenditures). 12 id. (noting that households purchased sickness insurance); palmer, supra note 6, at 2 (noting that fraternal orders had profitable burial insurance programs); preskitt, supra note 8, at 40 (noting that burial insurance was a significant part of insurance company business in the early 1900s). 13 preskitt, supra note 8, at 40 (affirming that physicians and pharmacists opposed insurance). 14 see thomasson, supra note 5, at 1-2 (stating that advances in medical technology along with a view of medicine as a science encouraged sick people to visit doctors and hospitals); preskitt, supra note 8, at 41 (noting that advances in medical technology caused the sick to visit doctors and hospitals). 15 see thomasson, supra note 5, at 2 (stating that increasing requirements for licensure and accreditation led to higher medical vol. 10:178 2013 why americans have a right to national health care result of such higher standards in the practice of medicine, many medical schools closed, which caused a shortage of doctors, although the demand for medical care itself increased. 16 all of these factors caused the price of medical care to rise precipitously. in 1929, this led some teachers in dallas, texas to create a prepaid hospital insurance plan that covered a three-week hospital stay at a fixed cost of six dollars.17 this was the first case of health insurance, as we know it, in the united states. throughout the 1930s, such prepaid plans were popular with the public who saw them as protection from ever-increasing bills, and with hospitals, which viewed them as a much-needed source of revenue.18 in the early 1930s, blue cross, inspired by the success of these plans, began to provide broader hospital insurance for working americans. by the late 1930s, blue shield instituted health insurance to cover doctor visits.19 such plans were additionally valuable because they allowed costs); preskitt, supra note 8, at 41 (affirming that increased requirements for licensure, education and accreditation put upward pressure on the costs of physicians' services); see also ronald hamowy, the early development of medical licensing laws in the united states, 1875-1900, http://mises.org/journals/jls/3_1/3_1_5.pdf (the need for such licensure requirements is easily appreciated when one realizes that it was not until 1889 that any american state (florida) required prospective doctors to obtain both a medical school diploma and pass a licensing examination. also, until 1915, alabama, colorado, and new mexico did not require doctors to attend medical school.). 16 duke university medical students, the history of medical schools in the us., vault.com, http://www.vault.com/wps/portal/usalvcm/detail/careeradvice/education-advice/the-history-of-medical-schools-in-theu.s.?id=5586&filterjtype=o&filterid=o (last visited oct. 13, 2012) (proclaiming that the proposal of a four-year medical school curriculum resulted in the closure of many medical schools). 17 id. at 2 (in 1929, a group of dallas teachers contracted with baylor university hospital to provide twenty-one days of hospitalization for a fixed rate of six dollars.). 18 thomasson, supra note 5, at 2 (stating that pre-paid hospital plans were mutually desirable to hospitals and subscribers during the 1930s). 19 id. at 2-3; see also preskitt, supra note 8, at 2 (asserting that blue cross provided hospital insurance and blue shield covered physician services). 79 indiana health law review employers to deduct the cost of employee health premiums and exempted employees from having to pay a tax on the benefit. 20 the 1940s ushered in a "golden age of medicine" due to expanded medical knowledge and prestige, improved hospital hygiene, and further advances in medical and scientific technology.21 because of such advances in medical care, and the fact that health insurance was not taxable to beneficiaries and was deductible to payees, by 1958, 75% of americans had some form of private health insurance. 22 however, because health insurance at this time amounted in the main to coverage for employees, an entire segment of the population, including the poor, unemployed, self-employed, and retired, received no health coverage. 23 to remedy this, the government introduced first medicare and then medicaid in the 1960s. 24 medicare is governmentsponsored insurance that is made up of two parts. part a covers hospital costs for all americans as soon as they reach sixty-five. part b is a supplement to part a that pays for seniors' doctor bills.2 5 medicaid provides the same coverage to the indigent.26 by 1970, as a result of more americans being covered because of medicare, medicaid, and private insurance, the 20 preskitt, supra note 8, at 3 (stating that employers did not have to pay taxes on money contributed and employees did not have to pay tax on the benefit). 21 dennis l. hufford, managed care: managing the monster, usafp.org (july 13, 1999), http://www.usafp.org/fac dev/leadership_ management/managed%20care/managed-care-ttp-handout.htm (last visited oct. 13, 2012). 22 preskitt, supra note 8, at 3 (noting that in 1958, 75% of americans were privately insured). 23 how did healthcare come about in the united states?, stay smart, stay healthy, http://www.staysmartstayhealthy.com/health care history-inthe united states (last visited oct. 13, 2012) [hereinafter stay smart, stay healthy]. 24 thomasson, supra note 5, at 5; see also history of health care financing in the usa, health economics, at 11-12, http://www. pharmpress.com/files/docs/health economicssample.pdf [hereinafter history of health care _fnancing in the usa]. 25 thomasson, supra note 5, at 5; stay smart, stay healthy, supra note 24, at 3. 26 stay smart, stay healthy, supra note 23, at 3. 80 vol. 10:1 2013 why americans have a right to national health care united states was spending over seventy billion dollars a year on health care. 27 in an attempt to control these costs, in 1973, congress passed the health maintenance organization (hmo) act.28 although the first hmos were introduced to reign in the federal government's health expenditures, by 1975 there were 178 hmos in the united states, providing close to six million individuals with private insurance. 29 in the 1980s, managed care expanded greatly in three ways. first, through preferred provider organizations (ppos), which combined "fee-for-service" protocols, whereby patients could choose to have doctors attend them who are not themselves members of the patients' hmo, with hmo coverage. second, point of service (pos) plans were created, which are similar to ppo plans in that they permit patients to visit out-of-network providers, but which differ from ppo plans in that pos plans have two schedules of benefits coverage depending on whether a treating doctor is in or out of network.30 third, exclusive provider organizations (epos) arrived, which function like small ppos, except that consumers can choose to deal directly with doctors within a group instead of individual in-network doctors; some epo plans will pay partial reimbursements to patients who go outside their network in emergencies. 31 health maintenance organizational health care has proven to be a huge mistake because all three of the above manifestations of its coverage, combined with the generally high cost of medical care, have priced many individuals out of the health care market. 32 as of 2010, the number of uninsured 27 history of health care financing in the usa, supra note 24, at 12. 28 id. at 13. 29 id. at 14. 30 id. at 17-18. 31 id.; see also epo insurance: what is an epo insurance plan.2 mama's health, http://www.mamashealth.com/insurance/epo.asp (last visited oct. 13, 2012). 32 see history of health care financing in the usa, supra note 24, at 24; les christie, number of people without health insurance climbs, cnn money (sept. 13, 2011, 5:22 pm), http://money. 81 indiana health law review americans was close to fifty million, or 16.3% of the population.33 often, this is not only due to the increased cost of premiums, but to ever-increasing deductibles and copayments that many, if not most, insurance plans require. 34 numerous attempts have been made over the years to reform aspects of national health care so that the problems so many americans have with health care could be avoided. in the past one hundred years alone, many american presidents including both roosevelts, truman, kennedy, johnson, nixon, ford, clinton, and obama, have examined various avenues to remedy our present health care crisis.35 unfortunately, most of these initiatives have failed.36 however, some have succeeded. in addition to cnn.com/2011/09/13/news/economy/censusbureauhealthinsurance/nd ex.htm (last visited oct. 13, 2012). 33 christie, supra note 32, at 1. 34 robert reich, "the wrong way to save money on healthcare," (sept. 14, 2012), http://www.guernicamag.com/daily/robert-reich-thewrong-way-to-save-money-on-healthcare. 3 meyer, supra note 6 (asserting that theodore roosevelt advocated for national health care in his last "bull moose" campaign); history of health care financing in the usa, supra note 24, at 7-22; kate pickert, the unsustainable us. health care system, time swampland (feb. 4, 2010), http://swampland.time.com/2010/02/04/theunsustainable-u-s-health-care-system/ (stating that obama desires to pass health reform legislation); walker, supra note 2 (noting that one of obama's biggest accomplishments is his health insurance reforms). 36 reasons for this failure include the opposition that physicians, pharmacists, insurance companies, and powerful lobbyists like the american medical association have had to most national health care proposals. see history of health care financing in the usa, supra note 24, at 9 (stating that the ama opposed national health insurance); thomasson, supra note 5 (asserting that physicians, pharmacists and insurance companies opposed compulsory health insurance). other reasons include ideological and philosophical differences between republicans and democrats, the fact that many individuals do not understand the complexities of the issues involved, and fear of communism. see also catherine hoffman, national health insurance a brief history of reform efforts in the us, the henry j. kaiser family foundation (march 2009), http://www.kff.org/healthreform/ upload/7871.pdf (stating that national health insurance proposals failed due to issue complexity, ideological differences, and special interest group lobbying, that opponents of national health care reform used fear of socialism and communism, and that political opposition was more organized than that which favored health reform). 82 vol. 10:1 2013 why americans have a right to national health care medicare and medicaid, such measures include the social security act of 1935, to the extent it factored the cost of medical care into an individual's monthly assistance copayments, 37 and the employee retirement income security act (erisa) of 1974, which expanded health coverage to protect the fringe benefits of employees. 38 erisa is a greatly modified form of national health coverage, for it overrules state employee regulations when employers use it to self-insure.39 in 1979, medicaid was expanded to include coverage for children and expectant mothers40 and in 1986 the consolidated omnibus budget reconciliation act (cobra) was passed, which required employers to continue to provide health insurance to employees for a period after their employment ends.41 in 1996, congress expanded erisa and cobra under the health insurance portability and accountability act (hipaa) to allow workers to exchange their insurance plans while employed and be covered under new plans if they lose their jobs. 42 although hipaa amounted to a godsend for american workers, it had the drawback of enormously high deductibles. 43 finally, president obama signed the patient protection and affordable care act (ppaca) into effect on march 23, 2010.44 this act's provisions will become binding 37 history of health care financing in the usa, supra note 24, at 7; thomasson, supra note 5 (stating that social security was viewed as a logical means of providing national health care). 38 history of health care financing in the usa, supra note 24, at 14-15 (emphasizing that the original purpose of erisa was to protect worker's fringe benefits). 39 id. at 15 (affirming that courts interpret erisa to override state regulation of employee insurance plans when employers are selfinsured). 40 id. at 17 (declaring that medicaid widened to include coverage for pregnant women and children). 41 id. at 18 (noting that cobra covers workers after employment termination). 42 id. at 20 (noting that hipaa's focus is to make insurance portable and continuous for employees). 43 id. at 20 (stating that hipaa deductibles in 1996 went from $1,600 to $2,400 for individuals and $3,200 to $4,800 for families). 44 fact sheet: the affordable care act's new patient's bill of rights, healthreform.gov (june 22, 2010), http://healthreform. gov/newsroom/new-patientsbill 83 indiana health law review over time and it will not be fully implemented until at least 2014.45 it dictates that americans cannot be denied coverage for pre-existing conditions,46 will have no lifetime limits on coverage, 47 and will have no copayments or deductibles for routine preventive care like colonoscopies, mammograms, and immunizations. 48 this history shows that (1) national health care for all americans is possible, (2) the government is finally moving in the right direction when it comes to national health care, and (3) the federal government has authority and power over health care in this country. the fact that the supreme court, in june 2012, ruled that the affordable care act is constitutional49 affirms this and may be used to position the ppaca as a giant step in the right direction toward some form of national health care, which the government is entitled to provide to americans.5 0 before we address the most ideal ofrights.html [hereinafter fact sheet: the affordable care act's new patient's bill of rights]; see also the affordable care act, section by section, healthcare.gov, http://www.healthcare.gov/law/full (last visited oct. 13, 2012). 45 fact sheet: the affordable care act's new patient's bill of rights, supra note 44 (noting that most of the act's protections will apply in full to all americans starting in 2014); see generally health reform in action, the white house, http://www.whitehouse.gov/ healthreform/healthcare-overview (last visited oct. 13, 2012) (claiming that benefits, protections, and savings will be implemented between now and 2014). 46 fact sheet: the affordable care act's new patient's bill of rights, supra note 44, at 2 (establishment of pre-existing insurance plan). 47 d. at 1-2 (noting that insurance companies can no longer place a lifetime limit on coverage). 48 id. at 2 (stating that the act covers select preventive services without charging out of pocket costs). 49 specifically, the court held that the "individual mandate" portion of the ppaca, which requires all americans to purchase some form of health insurance, does not invalidate the rest of the act. this is because the mandate may be viewed as a "tax" which congress has the power to levy and not a penalty. see nat'l fed'n of indep. bus. v. sebelius, 132 s. ct. 2566 (2012) (holding that the individual mandate may be construed as a tax and not a penalty). 50 the commerce power, derived from the commerce clause, is a principle reason the government may constitutionally provide americans with national health care. in wickard v. filburn, the court 84 vol. 10:1 2013 why americans have a right to national health care manner in which such care should be delivered to americans, we first examine whether americans have a right to health care under the constitution.5 1 iii. a right to health care under the constitution although the supreme court has yet to found a righto government sponsored health care that individuals need not pay for themselves, the court has found that, in certain circumstances, the government must provide health care to held that "the power to regulate interstate commerce includes the power to regulate the prices at which commodities in that commerce are dealt in and practices affecting such prices." 317 u.s. 111, 128 (1942). if this is true of wheat grown with the intention to be wholly consumed intrastate, scholars contend that insurance coverage which is sold interstate also comes within the commerce clause's grant of federal governmental authority. see jeremy leaming, opponents of health care law rely on wobbly federalism argument for a reason, american constitution society for law and policy (feb. 8, 2012), http://www.acslaw.org/acsblog/opponents-of-health-care-law-rely-onwobbly-federalism-argument-for-a-reason (last visited oct. 19, 2012) (southern california law professor rebecca l. brown believes that as 17% of the unites states economy participates in the health care market, the question of health insurance definitely falls under the commerce clause.); carrie dann, is the health care law constitutional? msnbc (feb. 4, 2011), http://www.msnbc.msn. comlid/41424402/ns/politics-more-politics/t/ health-care-law-constitution (law professor charles fried says the health insurance market clearly falls under the commerce clause.). the commerce clause of the united states constitution states, "the congress shall have power ... to regulate commerce with foreign nations, and among the several states, and with the indian tribes." u.s. const. art i, § 8, cl. 3. although the court held that the affordable care act is not a proper use of the commerce clause, nat' fed'n of indep. bus., 132 s. ct. at 2589 (stating that "the framers gave congress the power to regulate commerce, not to compelit") (emphasis in original), this was not because the court believed the act cannot come under the clause per se, but because the act's individual mandate attempts to compel, and not regulate, activity. id. at 2587 ("the individual mandate, however, does not regulate existing commercial activity. it instead compels individuals to become active in commerce by purchasing a product.") (emphasis in original). 51 the supreme court in nat' fed'n of indep. bus., did not grant americans a right to national health care. it ruled that the individual mandate portion of the ppaca exceeded congress's power under the commerce clause. 132 s. ct. at 2589. 85 indiana health law review prisoners because it would violate the eighth amendment's ban on "cruel and unusual punishment" to not do so. 52 the first argument then in favor of a health care plan that is available to all americans, regardless of their ability to pay, is an equal protection argument. just as prisoners must be provided with health care although they cannot pay for it themselves, all americans who cannot afford health insurance on their own must be provided with health care.53 this should be the case even if the court employs a "rational basis" and not a "strict scrutiny" standard to find such an equal protection based health care right.54 52 see estelle v. gamble, 429 u.s. 97, 101-08 (1976) (stating that deliberate indifference by prison personnel to a prisoner's serious illness or injury is cruel and unusual punishment). the fact that government officials must provide health care in certain cases to prisoners, informs a right to health care by a segment of the population. the eighth amendment to the constitution states, "excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishment inflicted." u.s. const. amend. viii. 53 equal protection arguments derive from the fourteenth amendment to the constitution, which states in part, "nor shall any state deprive any person of life, liberty, or property without due process of law; nor deny to any person within its jurisdiction the equal protections of the law." u.s. const. amend. xiv, § 1. although the fourteenth amendment applies on its face only to the states and not the federal government, the supreme court has held that intentionally discriminatory federal practices may violate the due process clause of the fifth amendment and be comparable to state equal protection violations. see bolling v. sharpe, 347 u.s. 497, 499 (1954) (concepts of equal protection and due process are not mutually exclusive). put differently, the due process clause fights federal discrimination the same way the equal protection clause combats state discrimination. the fifth amendment to the constitution states that "no person shall be . . . deprived of life, liberty, or property, without due process of law." u.s. const. amend. 5. 54 the supreme court follows a three-tiered protocol to discover whether equal protection and due process rights have been violated. see doug linder, exploring constitutional conflicts: levels of scrutiny under the equal protection clause, exploring constitutional law (2012), http://1aw2.umkc.edu/faculty/projects/ftrials/conlaw/ epcscrutiny.htm (last visited oct. 19, 2012). the strictest level of review, as seen from the perspective of the alleged victim, is "strict scrutiny." id. under this standard, a law that protects some persons, but not others who are "similarly situated," is legal only if it is necessary to serve a compelling government interest. id. the court 86 vol. 10:1 2013 why americans have a right to national health care uses an "intermediate" or "middle" level scrutiny to examine whether alleged discrimination is substantially related to an important government interest. id. finally, the court uses a "rational basis" or "minimum" scrutiny to find whether a challenged classification rationally serves a legitimate government interest. id. the court uses different levels of scrutiny depending on the suspect classification involved, in other words, whether a government policy discriminates against a maximally or minimally constitutionally protected group of individuals. for example, strict scrutiny seeks to protect fundamental rights in the context of equality and autonomy and readily applies to race, national origin, and religion. see laurence h. tribe, american constitutional law 1465 (2nd ed. 1988); linder, supra. intermediate scrutiny is used when the interest involved is important but not fundamental. it applies to gender discrimination and cases of identity differentiation, for example, when illegitimate offspring are treated differently than legal offspring. see tribe, supra, at 1601-02, 1610-18; linder, supra. rational basis review generally favors a given governmental regulation because it is satisfied as long as there is any rational reason for such regulation. this is true even of regulations that treat people in a lesser-protected class unequally. see tribe, supra, at 1439-40, 1446-47; linder, supra. such a minimum level of scrutiny has been applied by the court to homosexuals and children of illegal aliens and in socioeconomic regulation cases. see tribe, supra, at 1439-40; linder, supra. in arguing that health care legislation that does not give the poor access to health care coverage would probably not pass muster even under a rational basis standard, i do not suggest that rational basis review should be employed to find a right to national health care. in fact, i believe strict scrutiny should be used to protect the poor from government regulations which discriminate against them, especially when it comes to health care. in this i am guided by justice stone, in united states v. carolene products, who held that strict scrutiny should be used to eradicate "prejudice against discrete and insular minorities . . . which tends . . . to curtail the operation of those . . . processes ordinarily to be relied upon to protect minorities." see tribe, supra at 1465 (citing united states v. carolene products, 304 u.s. 144, 153 n.4 (1938)). certainly, the poor constitute a minority whose interests should be protected as much as other minority members like children and prisoners. i believe, however, that even a rational basis review would uphold national health care legislation for all americans, including the poor in the face of comparably existing care for prisoners, for what rational basis is there for the government to provide health care to prisoners but not the poor? this question is compounded upon appreciation that the federal government provides health care to lowincome children through its national children's health insurance program (chip). see childien's health insurance program (chip), ncsl: national conference of state legislatures, http:// www.ncsl.org/issues-research/health/childrens-health-insurance87 indiana health law review a second constitutional basis for national health care is the government's taxing and spending power, enumerated in article 1, § 8, clause 1, which states in part that "[t]he congress shall have power to lay and collect taxes ... to . . . provide for the . . . general welfare of the united states." the last part of this section gives congress authority to "make all laws which shall be necessary and proper for carrying into execution the foregoing powers."5 5 when we appreciate that the individual clauses, together with the above provisos, grant congress the power to do whatever it must to insure a common defense,56 regulate interstate commerce,5 7 enact requirements for citizenship,5 8 coin money,59 establish post offices,60 and declare war,61 it is obvious that health care is as much of a prerequisite to the "general welfare" of the united states as any of the above listed necessities are. 62 moreover, that health care is a program-overview.aspx (last visited oct. 19, 2012). the poor, like prisoners and children, do not have access to health care when left to their own ability to pay for it. 55 u.s. const. art. 1, § 8, cl. 18. 56 id. at cl. 1. 5 id. at cl. 3. 58 id. at cl. 4. 59 id. at cl. 5. 60 id. at cl. 7. 61 id. at cl. 11. 62 many of the arguments that favor national health care are viewed as stemming from liberal, expansive readings of the constitution. see generally thomas bodenheimer, the political divide in health care: a liberal perspective, 24 health aff. 1426 (2005), available at http://content.healthaffairs.org/content/24/6/1426.full (stating that in the health care arena, many liberals feel that governments are the only institutions that can protect people's right to receive essential services including heath care). however, even an original intentionalist must acknowledge that the framers, who did not know of private or national health coverage, would have demanded it, as they provided all the enumerated constitutional mandates of article 1, section 8, to further ensure the welfare and prosperity of american society. if anything, the framers would have been more solicitous of universal health care than they were of the listed powers, for a polity that does not have its health needs met may very well prove unable, in any given instance, to engage in commerce, deliver the mail, or defend itself. in fact, at least one prominent conservative federal appellate jurist has denied that original intent renders the ppaca 88 vol. 10:1 2013 why americans have a right to national health care right, and not a privilege, inheres in the fact that the above enumerated powers, and the general welfare clause, are contained in the article which grants congress taxation power. to be sure, if i as an american, have the right to a militia to protect me from invasion, a post office to deliver my mail, and a treasury to print money so i may engage in commerce, it follows that because i pay taxes, i have the right to have a portion of those taxes used to provide me with access to preventive health care to keep me well and to curative care should i get sick. another argument in favor of national health care is found in the tenor of the entire corpus of america's founding documents, including the articles of confederation, all parts of the constitution, and the declaration of independence. to be sure, the totality of these writings bespeaks a desire on the part of america's founders to establish a government, under the rule of law, which would provide its citizens with opportunities conducive to their prosperity and well-being.63 not only is this clear from the enumerated and unenumerated rights contained in the constitution, it is obvious from language included in the constitution and other documents that is not traditionally read to create rights.64 for example, although the preamble to the unconstitutional. see paul, dc circuit upholds healthcare law and demolishes right's arguments, people for the american way (nov. 8, 2011, 4:14 pm), http://blog.pfaw.org/content/dc-circuit-upholdshealthcare-law-and-demolishes-rights-arguments (noting that judge silberman does not agree that original intent renders the mandate that individuals purchase health insurance unconstitutional). 63 see e.g., articles of confederation of 1781, art. iii ("the said states hereby severally enter into a firm league of friendship with each other, for their common defence . .. and their mutual and general welfare.") (emphasis added); declaration of independence ("we hold these truths to be self-evident, that all men . . . are endowed . . . with certain unalienable rights, that among these are life, liberty, and the pursuit of happiness. that to secure these rights, governments are instituted among men.") (emphasis added); u.s. const., pmbl. ("we the people of the united states, in order to form a more perfect union ... insure domestic thanquility . . . promote the general welfare . . . do ordain and establish this constitution.") (emphasis added). 64 see what are the parts of the constitution, laws.com, http://constitution.laws.com/american-history/constitution/theconstitution (last visited oct. 13, 2012) (stating that the preamble was 89 indiana health law review constitution is said to have no legal authority,6 5 it does explain the "why" of the constitution, namely, the six ends for which the constitution was created. these goals are: (1) to form a more perfect union, (2) establish justice, (3) insure domestic tranquility, (4) provide for the common defense, (5) promote the general welfare, and (6) secure the blessings of liberty.6 6 it is inconceivable that americans, who possess the founding father's way of informing future generations of their motives and intent in writing the constitution). 65 this seems to be the view of the supreme court. for example, see jacobson v. commw. of mass., 197 u.s. 11, 22 (1905) (asserting that the preamble has never been regarded as the source of any substantive power). however, the court itself has opined that every word in the constitution, which presumably includes the preamble, must be given "due force" in interpreting what the document means. see richfield oil corporation v. state board of equalization, 329 u.s. 69, 77-8 (1946) ("in expounding the constitution of the united states, every word must have its due force, an appropriate meaning . . . no word in the instrument, therefore, can be rejected as superfluous or unmeaning.") (citing holmes v. jennison, 39 u.s. 540, 570-71 (1840)). moreover, president monroe believed the preamble should be considered key to understanding the constitution. see judicial branch: constitutional role of the judicial branch, enotes http://www.enotes.com/judicialbranch-reference! constitutional-role-judicial-branch (last visited oct. 13, 2012) ("the introduction, like the preamble to a law, is the key of the constitution."). moreover, some constitutional scholars believe the preamble, and other founding documents, may be used to find constitutional norms. see generally jack m. balkan & sanford levinson, legal historicism and legal academics: the roles of law professors in the wake of bush v. gore, 90 geo. l.j. 173, 178 (2001) (noting the constitutional norms articulated in "thin constitution" whose principles are outlined in the declaration of independence and the preamble to the constitution); a national health care that gives all americans access to medical care would enable many more people to determine, and participate in, the progress of society. finally, professor laurence tribe, of harvard law school, believes the preamble and declaration are "important sources of authority" for finding a constitutional right to health care (email from laurence tribe, professor of law at harvard law school, (feb. 16, 2012, 19:30 est) (on file with author)), and professor mark brandon, of vanderbilt law school, is "committed to a position that encourages use of the preamble in constitutional interpretation" (email from mark brandon, professor of law at vanderbilt law school, (mar. 22, 2012, 20:12 est) (on file with author)). 66 see u.s. const. pmbl. 90 vol. 10:1 2013 why americans have a right to national health care constitutional rights to speak freely and assemble, 67 have speedy and public trials,68 and vote,69 do not have a constitutional right to have their government provide them with health care. one final constitutional argument in favor of a right to national health care is twofold. first, the framers of the constitution fashioned the ninth amendment specifically to allow for the establishment of rights in the future that are not explicitly mentioned in the text of the constitution. 70 second, because the ninth amendment fails to provide guidance on how to found unenumerated rights, it implicitly warrants that nontextual criteria, such as need, may be used to found such rights.71 to be sure, what could be a more compelling reason for a "new" right than because there is a need?72 67 see u.s. const. amend. i. 68 see u.s. const. amend. vi. 69 see u.s. const. amend. xv, xix, & xxvi. 70 see u.s. const. amend. ix; daniel a. farber, the 'silent' ninth amendment gives americans rights they don't know they have (2007). 71 the great jurist, oliver wendell holmes, jr., expressed this idea in different words when he stated famously in the common law that "the life of the law has not been logic: it has been experience." see oliver w. holmes, jr., the common law (1881), available at http://constitution.org/cmt/owh/commonlaw.txt. by this, holmes means that human "experience," i.e. our needs, or the things that shape our lives, and society in general, inform our laws, more than other factors. id. ("the felt necessities of the time, the prevalent moral and political theories, intuitions of public policy . . . have had a good deal more to do . . . in determining the rules by which men should be governed."). holmes's opinion belongs to a school of legal thought called legal realism, which holds that more often than not, judges decide legal cases based not on rules, but on their intuitions, experiences, and prejudices, to find results which they feel are necessary in the face of given facts. see bradley c. s. watson, oliver wendell holmes, jr. and the natural la w, natural law, natural rights and american constitutionalism, http://www.nlnrac. org/print/34 (last visited oct. 13, 2012) ("[clourts adjudicate with an eye to law's practical effects."). for an excellent article about legal realism, see kenneth e. himma, philosophy of law, the internet encyclopedia of philosophy, http://www.iep.utm.edullaw-phil (last visited oct. 19, 2012). 72 it may be the fact that national health care is debated at all, much less to the extent it is, proves that, to many individuals, health care is a necessity and not a luxury or even a commodity. to be sure, 91 indiana health law review this latter point serves to rebut all those who deny there is a right to health care because such a right is not found in the constitution.73 now, how a right to health care should be implemented is something that, ultimately, must be established by the legislature, in the same way it is for congress to decide the means by which enumerated rights are enjoyed. however, because the ninth amendment acknowledges that an evolving society may find rights not mentioned in the text of the constitution, the necessity of something that is required for the welfare of americans can itself create a constitutional right. now that the reasons why americans possess a constitutional right to health care have been presented, below is a discussion on the different ways such a right may be implemented. 74 were health care seen as a luxury, it would not be gist for intelligent debate. after all, we do not see serious people arguing about whether the poor should have access to luxury automobiles or iphones. see bodenheimer, supra note 62, at 1429 (stating that few would endorse the right of everyone to own a dvd player or drive a luxury car). 73 see david meyers, commerce clause jurisprudence and original intent in health care, jurist (july 7, 2011), http://jurist.org/dateline/2011/07/david-meyers-commerce-clause.php (last visited oct. 19, 2012) (declaring that a national health care mandate is unconstitutional because the commerce clause has been interpreted way beyond what it actually states); geoff b., you do not have a right' to health care, the millennial star (may 18, 2011), http://www.millennialstar.org/you-do-not-have-a-right-to-health-care (asserting that supposed rights to health care are not in the constitution and were never intended to be); health insurance is not a right, people. the bobo files (july 30, 2009), http:// thebobofiles.com/?p=1517 ("nowhere in our constitution does it say that every individual in this country has the right to health care."). 74 for the sake of thoroughness i note another, albeit nonconstitution based, reason americans are entitled to health care access. the united states provides financial assistance, not just to its own residents, but to the citizens of numerous foreign governments. much such aid is not only to help such people, but for national security purposes, i.e. to protect americans from their enemies. yet, the actual amount of money we give to others is beyond unreasonable when one considers that, as a result, we cannot afford to cover all of our own people with adequate government-sponsored health care. laurie garrett, the us. promotes universal health care, but only in other countries, http://www.theatlantic.comlinternationallarchive/2012/06/ the-us-promotes-universal-health-care-but-only-in-other-countries/ 92 vol. 10:1 2013 why americans have a right to national health care iv. ways to provide access to national health care there are essentially three ways to implement national health care: single-payer health care, hybrid or two-tier health care, and private national health care.75 in singlepayer health care, the government pays for everyone's care from a fund set aside specifically for this purpose.76 with hybrid health care, health care is paid for through a combination of government and private sources.77 in national but private health care, individuals must fund their own care, but government resources are available to subsidize those who cannot entirely afford to do so.7 8 259160/ (last visited jan. 31, 2013). even buying into the view that health care for those who cannot afford it is charity, "charity begins at home," and the united states should take care of its own before it spends as much as it does to build up foreign societies. one major way the u. s. can help its own is to provide its residents with health care. the fact is that other countries, like japan and canada, spend less in both dollars and gdp percentage than we do on security so they can give their citizens health care, yet they appear to have more than enough resources to keep their borders secure and their citizens safe. our government should learn from their example. see talea miller & larisa epatko, foreign aid facing proposed cuts and a public perception problem, pbs newshour (march 10, 2011), http://www.pbs.org/newshour/rundown/2011/03/foreign-aid-facingproposed-cuts-public-perception-problem.html (stating that in 2009, the u.s. spent 28.8 billion dollars and .21% of its gdp, japan spent 9.5 billion and 0.18% of its gdp, and canada spent 4 billion and only 0.3% of its gdp, on foreign aid). 7 see universal health care, quick overview, http://www. quickoverview.com/issues/universal-healthcare-system.html (last visited oct. 14, 2012). 76 see single-payer faq, physicians for a national health program, http://www.pnhp.org/print/facts/single-payer-faq (last visited oct. 10, 2012) [hereinafter physicians for a national health program]; universal health care, supra note 75 ("single-payer health care is a system whereby one party, usually the government, pays for the health care of everyone."). 7 see andrew cohen, spotlight berkeley chefs promotes hybrid health reform, berkeleylaw (feb. 24, 2009), http:// www.law.berkeley.edul3811.htm ("hybrid health care describes universal coverage that combines elements of government-run programs and private-sector insurance plans.") 78 see mandatory health insurance requirement begins in 2014, individual health plans (oct. 27, 2011, 1:27 pm), http://www. 93 indiana health law review although all such approaches have some merit,79 the best avenue by far that the united states should take to insure its people is a single-payer approach. this is for at least six reasons. first, unlike private insurance and even hybrid health care, all americans regardless of income and assets would be covered for all medically necessary services, including physician visits and services, hospitalization, long-term care, dental needs, vision care, and prescription drug and medical supply costs.80 such a plan is extremely necessary, because presently many government subsidized programs exclude many of the above services.81 second, because a single-payer system will be funded and operated by a single entity, i.e. the government, it will cut down on individual-health-plans.com/blog/mandatory-health-insurance [hereinafter individual health plans] (starting in 2014, americans must carry health insurance and the government may subsidize health insurance for those who make less than a certain amount.). 7 see cohen, supra note 77 (a hybrid insurance plan "creates a new, publicly funded and administered health plan, gives the uninsured choice among alternative plans, and expands access to existing public insurance programs."); universal health care, supra note 75 (noting that hybrid health care takes the burden of universal health coverage off the exclusive shoulders of the government, reconciles the competing interests of expanded access and rising costs, and negotiates a middle ground answer to whether universal health coverage is a personal or societal responsibility); marissa willman, what are the benefits of private health care? ehow, http://www.ehow.com/print/facts_ 5030832_benefits-private-health-care.html (last visited oct. 14, 2012) (private health care grants choice, ensures greater quality, eliminates waiting periods, and reduces government spending); alan nasser, obama's bad case against single payer: solidarity vs. individualism, commondreams (nov. 18, 2009), http://www.commondreams.org/ view/2009/11/18-5 (declaring that single-payer insurance has a majority of popular support, it detaches coverage from employment, makes national health care truly universal, and it promotes solidarity in both private and governmental vantage points). s0 see physicians for a national health program, supra note 76. 81 see e.g., individuals and sole proprietors: benefit package, healthy ny, http://www.dfs.ny.gov/healthyny/hnyind sole-bp.htm (last visited oct. 10, 2012) (healthy new york, a new york state subsidized plan for low-income residents, that is provided by various insurance companies excludes "durable medical equipment" such as cpap machines used to treat sleep apnea and mental, vision, and dental care. 94 vol. 10:1 2013 why americans have a right to national health care the administrative costs that private and hybrid insurance plans require. 82 third, a single-payer plan will keep drug prices under control. this is because when patients are covered under one system, the payer, in this case the government, has more power to control costs than when multiple sources are responsible for providing drug care. to be sure, the unified source of their health care is a major reason drug prices in other countries are lower than they are in the u.s.83 fourth, because single-payer plans would cover items that are not traditionally covered in many plans, and would probably not carry copayments or deductibles, 84 they would provide coverage to the presently 82 see physicians for a national health program, supra note 76 ("the new costs to cover the uninsured under a single-payer system will be fully offset by administrative savings."); mark crane, us md administrative costs 4 times higher than in ontario, medscape medical news (aug. 3, 2011), http://www.medscape.com/viewarticle/ 747566. 83 see physicians for a national health program, supra note 76 (stating that the clout that comes from having patients under one system is the reason single-payer country drug costs are lower than those in the u.s.); tracy staton, europe pays 40% less for drugs than u.s, fierce pharma (july 8, 2009), http://www.fiercepharma.com/ story/europe-pays-40-less-drugs-u-s/2009-07-08; terry campbell et al., costs of health care administration in the united states and canada, 349 new eng. j. med. 768 (2003), available at http://www.nejm.org/ doilfull/10.1056/nejmsao22033 (emphasizing that the gap between the u.s. and canada in health care expenditures might be reduced if administrative costs in the u.s. were trimmed through the adoption of a canadian-style health care system). 84 the question of what purpose copayments and deductibles serve is an interesting one. insurance companies claim they reduce the cost of health care. see what is a copay?, insurance providers, http://www.insuranceproviders.com/what-is-a-copay (last visited oct. 10, 2012) (explaining that paying higher copays saves consumers money on premiums). others suggest co-payments motivate patients to take their medical care more seriously. see ilyne sandas & christine siegel, managing managed care plans: co-pays, netplaces, http://www. netplaces.com/parenting-kids-with-anxiety/managing-managed-careplans/co-pays.htm (last visited oct. 10, 2012) (arguing that making a financial contribution at the time of service may increase patient motivation and follow-through). the fact remains, however, that those with high copayments and deductibles frequently do not receive the care they need or do not benefit from such care as often as they would if they were not burdened with copays and deductibles. see rhonda day, 95 indiana health law review underinsured as well as the uninsured.8 5 this is vital because as recently as 2009, 62% of u.s. bankruptcies were due to medical expenses and 80% of those bankruptcies were filed by people who had health insurance.86 fifth, a national single-payer health plan will keep overall health care costs down by de-commercializing health care and limiting for-profit involvement in how health care is delivered.87 it would accomplish this in three ways. first, the payer (the government) would not spend more on medical technology than is needed to provide health care.8 8 second, because a single-payer system would be delivered by the government, it would eliminate the excessive executive compensation packages in vogue at private insurance companies.89 third, it would block the often white house issues new rules to eliminate copays and deductibles for preventive screenings and tests, examiner.com (july 15, 2010), http://www.examiner.com/article/white-house-issues-new-rules-toeliminate-copays-and-deductibles-for-preventive-screenings-and-tests (explaining that access to health services often limited by copayments, deductibles, and other financial burdens). those with high copayments and deductibles also do not comply as well with their need to take medicine. see martin sipkoff, lowering copayments can improve quality -of chronic disease care, managed care (july 2007), http://www.managedcaremag.comlarchives/0707/0707.medmgmt.html (noting that one aetna client is convinced that lowering or eliminating copayments will increase compliance). 85 see physicians for a national health program, supra note 76 (declaring that the most effective system to combat an epidemic of underinsurance is a single-payer one). 86 see meg white, 25 million underinsured americans might as well be on the moon'for their access to medical treatment, buzzflash (oct. 16, 2009), http://www.truth-out.org/buzzflash/commentary/item/ 812525-million-underinsured-americans-might-as-well-be-on-the-moonfor-their-access-to-medical-treatment (explaining that 80% of the'62% of bankruptcies due to medical care are filed by the underinsured). 87 see physicians for a national health program, supra note 76 (stating that the keys to savings lie in limitations on for profit involvement in health care delivery). 88 id. (arguing that health planning to assure that investments in expensive new technology meet needs but do not exceed them is the only proven means to limit excessive and dangerous interventions that drive up costs). 89 id. (noting that limits on excessive compensation of health care executives are needed). vol. 10:196 2013 why americans have a right to national health care enormous costs insurance companies spend to influence the public that private health insurance is the preferred manner in which they should obtain their health insurance.90 finally, because a single-payer plan would be operated by the government, all medical data, including patient and hospital records, could be housed in one central computerized repository.91 this would further keep administrative costs down, discourage doctors from fraudulently billing for unperformed procedures, 92 and make it much easier to coordinate patient health data between physicians and hospitals in the event a patient changes doctors or moves to another locale. 93 v. arguments against national single-payer health care in spite of these reasons in favor of national single-payer health care, many individuals, in the medical profession and without, raise seemingly cogent arguments against such a system. although it is impossible to visit all such objections in this paper, i examine some important ones. first, there is a worry that if the government controls health care, it will take control over patient care away from patients and their doctors. 94 however, because a single-payer program 90 see sudbury (ma) democratic town committee, singlepayer universal health care: an idea whose time has come 4-5 (2009), available at http://www.sudburydemocrats.org/pdf files/ singlepayer.pdf [hereinafter sudbury (ma) democratic town committee] (declaring that pharmaceutical and insurance companies spend a significant amount of money cultivating influence). 91 see kao-ping chua, single payer 101, american medical student association, http://www.amsa.org/amsa/libraries/ committee_ docs/singlepayerl0l.sflb.ashx 92 see arnold relman, in dire health, the american prospect (jan. 13, 2012), available at http://prospect.org/article/dire-health (arguing that in a single-payer system there would be no bills and little or no fraudulent billing); see kao, supra note 91. 93 see gordon schiff and the pnhp working group on quality, how single-payer health system reform improves quality, http://www. pnhp.org/facts/quality.pdf. 94 physicians for a national health program, supra note 76, ("there is a myth that with national health insurance the government will make the medical decisions."). 97 indiana health law review would be run by the government, it would be public, and therefore the public would have a say in how it is run and patients and doctors would remain in control of health care.95 second, it is feared that under a single-payer program, physicians' salaries and fees will go down which could cause qualified individuals to choose other professions to go into, and exceptional ones to quit the profession.9 6 although it is true that many american physicians are leaving medicine to pursue other careers, 97 this is more often due to frustration with having to deal with hmos than with dissatisfaction with the medical profession. 98 third, it is objected that adapting a single-payer national health care system will unfairly eliminate most of the present insurance industry's administrative workers. 99 although it is true that many who work for hmos and other private insurance companies will need to be placed in other positions and possibly other professions, this is not a valid reason to reject 9 see frequently asked questions about single payer health insurance, texans for a national health program, http://www.healthcareforalltexas.org/faqs.pdf (last visited oct. 10, 2012) (in a publicly-financed universal health care system medical decisions are left to patient and doctor.); physicians for a national health program, supra note 76 (in a publicly-financed universal health care system, medical decisions are left to the patient and doctor.). 96 see physicians for a national health program, supra note 76. 97 see valerie m. harrison, being a doctor, pros, cons and what it's really like. the process of becoming a doctor, mommd, http://www.mommd.com/beingadoctor.shtml (last visited oct. 19, 2012) (many good doctors are leaving the profession.). 98 see kevin pho, why pediatricians and other primary care doctors leave medicine, medpagetoday's kevinmd.com, http://www.kevinmd.com/blog/2010/06/pediatricians-primary-caredoctors-leave-medicine.html (last visited oct. 10, 2012) (explaining examples of frustrations doctors have dealing with hmos); q & a: maggie kozel on leaving medicine, chelsea green publishing (feb. 24, 2011, 8:55 am), http://www.chelseagreen.com/content/qa-maggie-kozelon-leaving-medicine (explaining that the frustration of dealing with hmos caused pediatrician to quit medicine). 9 see physicians for a national health program, supra note 76. vol. 10:198 2013 why americans have a right to national health care a more cogent and fair health care program. 00 moreover, a single-payer protocol would still need a healthy cadre of administrative employees, and many who currently work for hmos and other private insurance companies can easily be retrained to handle claims and other duties under a national insurance program. 101 fourth, it is argued that a competitive, private, free market approach to health care would streamline health care costs to make them more cost effective.102 however, it is precisely the competition between insurance companies in the private sector that has caused the costs of health insurance to spiral out of control and become unaffordable for so many.103 a single-payer plan, by providing health care to all americans regardless of their ability to pay, would keep health care costs down particularly because such a program will not need to spend small fortunes on advertising, consumer influence, and the administrative costs associated with these realities.104 the lack of competition as a cost-controlling mechanism would apply to hospitals as well as private insurance companies. 05 100 after all, did society refrain from embracing the automobile because doing so put innumerable horse-and-buggy drivers out of work? 101 see physicians for a national health program, supra note 76 (stating that the new system will still need some people to administer claims and work in long-term care facilities and nursing homes). 102 see id. ("competition will streamline the costs of health care and make it more efficient."). 103 see id. (noting that past competition in private health care is the major cause of rising costs); see also angry bear, the return of the myth that competition will fix medicare, business insider (apr. 5, 2011), http://articles.businessinsider.com/2011-04-05/markets/29991557 1_health-insurance ("health insurance premiums for workers in large companies . . . covered by private, competitive, employer-sponsored health insurance plans -rose over 135% over the ten year period 1999 and 2009.") (emphasis in original). 104 see sudbury (ma) democratic town committee, supra note 90 at 3, 4-5 (noting the "extraordinary and wasteful insurance company advertising costs" and that insurance companies "spend a significant amount to cultivate influence"). 105 see physicians for a national health program, supra note 76 (noting that hospital competition "drives up overall medical costs" and "waste[s] money on advertising and marketing"). 99 indiana health law review another objection to single-payer insurance is that it would eliminate, reduce, or hamper medical research. 106 however, already this does not appear to be the case because much, if not most, research in this country is financed by the national institutes of health (nih),107 a government agency that has innovated many medical treatments and cures. 108 moreover, many medical discoveries and treatments we take for granted today were discovered in countries that operate under national health care systems.109 for example, the ct-scan was invented in england, and much of how we understand the genetic basis of alzheimer's disease was gleaned from research conducted in france and england.110 another argument against government-sponsored health care programs is that they will raise taxes."' although it is 106 see david hogberg, the myths of single-payer health care, free market cure, http://freemarketcure.com/singlepayermyths.php (last visited oct. 12, 2012) ("while it is true that medical research will not 'disappear,' it will surely decline."); see also trisha torrey, the role of medical research in healthcare reform: the ripple effect of conflicts of interest and money allocations on patients, about.com (oct. 26, 2011) http://patients.about.com/od/healthcarereform/a/reform-research. htm (noting that less money is available for research by government sources and insurance companies and that private enterprise have become major funders of research). 107 see physicians for a national health program, supra note 76 ("much current research is funded through the national institutes of health."). 108 see turning discovery into health, nih, http://www.nih.gov/ about/impact/impact health.pdf (last visited oct. 13, 2012) (noting that nih-funded research is tied to 60% lower death rate for coronary artery disease, the increased survival rates for various forms of cancer, and the development of vaccinations). 109 myths-overview, health care for all-texas, http://www. healthcareforalltexas.org/myths.html (last visited oct. 13, 2012) [hereinafter health care for all texas] ("many [medical] discoveries have been made in countries that have national health care systems . . ."). 110 see id. n1 see peter grier, health care reform bill 101: who will pay for reform?, christian scl. monitor (mar. 21, 2010), http://www. csmonitor.comfusa/politics/2010/0321/health-care-reform-bill-101who-will-pay-for-reform (noting that some of the $940 billion required to pay health care reform over ten years will come from new taxes). 100 vol. 10:1 2013 why americans have a right to national health care 101 true that any form of national health care will need to be realized through higher taxes, this fact in itself should not be fatal to national health care. first, such taxation, which can be levied uniformly and fairly based on income, may very well prove to be preferable, and ultimately less expensive, than the insurance premiums, copayments, deductibles, that many americans are burdened with.112 furthermore, it is through taxation that americans fund police and sanitation departments, public education, the military, and social security, institutions that most, if not all, americans agree are of vital importance to society.113 moreover, through their taxes, americans are already paying for the health care of the uninsured.114 raising taxes to pay for a national health care program would simply streamline this reality and make it more equitable for all americans by using the taxes of each american to pay for everyone's health care. finally, because national health care is a right that all americans, regardless of income, should enjoy, it may be considered a public necessity in the same manner as access to police protection, sanitation, public education, and bridges and parks, is. seen in this light, there should be no more objection to using taxation to pay for national health care than there is for any other societal benefit. having examined the history of health care, whether national health care is a right, how it should be implemented, and some of the arguments against it, i now look to ways in which national health care can be funded. 112 see health care for all texas, supra note 109 ("all new taxes would take the place of current insurance premiums, co-pays, deductibles and any and all other out of pocket payments."). 113 see policy basics: where do our state tax dollars go., ctr. on budget and pol'y priorities, http://www.cbpp.org/files/policybasicsstatetaxdollars.pdf (last visited oct. 19, 2012) (noting that state tax dollars are spent on education, police, help for the poor, corrections and other essential state services); see also how your tax dollars are spent, cnbc.com, http://www.cnbc.comid/26941466/?slide=l (last visited oct. 13, 2012). 114 see aetna, supra note 3. indiana health law review vi. how a national health care program should be funded there are three ways to fund national health care plans. all of them involve using taxpayers' dollars. the only difference between them is the degree of direct taxpayer involvement and whether the government will be exclusively or partially responsible for the costs of such care. for example, a national health care system can be realized by americans paying government health care premiums out of pocket. the amount of such premiums would depend on income. those who earn more would pay more and naturally, those who earn less would pay less. americans whose income is below a certain level would be exempt from such premiums; their care would be paid for entirely by the government.115 other ways national health care can be paid for are deducting the cost of one's annual health care from her paycheck, paying upfront for services and being reimbursed by the government,116 and permitting health consumers to deduct the value of all their health expenditures on their tax returns. 117 the self-employed would pay government subsidized premiums, and lowincome individuals would be covered completely and upfront by the government. 115 see premium and cost-sharing subsidies in the affordable care act, communitycatalyst.org (sept. 2010), http://www. communitycatalyst.org/docstore/publications/affordabilityinaca.pdf (noting that tax credits starting in 2014 will lower the costs of premiums and providing tables that show premiums are based on income levels); see also individual health plans, supra note 78 ("the less money you make, the more your health coverage will be subsidized."). 116 see steve gold, how european nations run national health services, the guardian (u.k.) (may 11, 2011), http://www.guardian. co.uk/healthcare-network/20 11/may/1 1/european-healthcare-servicesbelgium-france-germany-sweden (noting that german citizens pay into one of three hundred sickness funds through their payroll or bank and that french citizens are immediately reimbursed by the government for doctor visits they pay for). 117 see william perez, deducting health insurance, about.com (mar. 15, 2011), http://taxes.about.com/b/2011/03/16/%20deductinghealth-insurance.htm (noting that americans can deduct the cost of health insurance on their income tax returns). 102 vol. 10:1 2013 why americans have a right to national health care 103 finally, as we have seen, a government sponsored national health care plan can be funded by taxpayer contributions and delivered by the government via a singlepayer system without any upfront expenditures and reimbursements or payroll deductions. this is the most cogent manner national health care should be implemented for at least three reasons. first, it would be truly "national" inasmuch as it would cover all americans without regard to income. second, it would exponentially cut down on administrative costs and bureaucratic involvement because, unlike the german and french systems, there would not be as much of a need to keep track of what or when residents have paid for health care or deal with the extra paperwork involved to repay nationals for their lay-outs in a timely fashion. however, under a single-payer system there will still be a need for paperwork or record keeping, as some governmental patient health care tracking would be required.118 also, record keeping promotes four important values. first, to ensure that patients are not over treated. second, it combats fraud. third, it ensures that doctors, hospitals, and other health care workers are appropriately compensated. fourth, it helps to protect doctors from illegitimate malpractice suits. third, any health care program that allows the government to pay health costs without out-of-pocket, upfront payments, will psychologically reinforce the idea that government health care is something all americans are entitled to by right.119 we have examined historical, constitutional, and pragmatic aspects of national health care. we now visit two philosophical issues that pertain to all governmentsponsored health plans. first, i examine the perceived injustice of requiring more affluent and healthy americans to contribute through their tax dollars to the health care of the unhealthy and less affluent. second, i examine the inherent tension between the political philosophy of a 118 see medical record keeping for health care providers, nursinglink.monster.com/training/articles/352-medical-record-xe (last visited jan. 31, 2013). us see kao, supra note 91. indiana health law review national health care program, which is socialist, in a capitalist country like the united states. vii. philosophical issues and questions of fairness over national health care an issue that crops up repeatedly regarding national health care plans is the seeming unfairness of requiring more affluent and healthy individuals to pay, indirectly through taxation, for the health needs of the less affluent and less healthy in society.120 this objection is often compounded and complemented by the realization that many americans bring disease onto themselves through lack of exercise and unhealthy food choices. 121 although there is truth to this complaint, when health care is seen as a right, it loses much of its bite. this is because there are numerous other areas of american life, from police protection and sanitation benefits, to public school education and military operations, which are supported by the tax dollars of americans who live in affluent and clean neighborhoods that may not need as much police 120 see things considered, arguments against universal healthcare in america, hubpages.com, http://thingsconsidered. hubpages.com/hub/arguments-against-universal-healthcare-inamerica (last visited oct. 13, 2012) (discussing why healthy people should have to pay for unhealthy people); see also geoff b., supra note 73 (noting there is no right to health care under the principles of natural law); see also claire andre et al., voluntary health risks: who should pay?, santa clara university, http://www.scu.edulethics/ publications/iie/v6n1/voluntary.html (last visited oct. 13, 2012) (proposing that people should pay for their own health risks). 121 see joe messerli, should the government provide free universal health care for all americans? balancedpolitics.org, http://www.balancedpolitics.org/universal-health-care.htm (last visited oct. 13, 2012) (noting that universal health care means the costs will be spread to all americans, regardless of health or medical need, which is fundamentally unfair because it punishes those who take care of themselves and rewards those who do not); see also shereen jegtvig, americans are not living a healthy lifestyle, about.com (jul. 6, 2012), http://nutrition.about.com/od/researchstudies/a/unhealthyams. htm (noting an unhealthy lifestyle means more illnesses, more individual health expenses, and more of a burden on the healthcare system). 104 vol. 10:1 2013 why americans have a right to national health care 105 surveillance, or clean-up, as poorer, crime-ridden locales do, or who may not agree with all details of foreign policy expenditures. the fact is that just as police protection, sanitation benefits, educational resources, and a strong military presence are necessary if society is to function at a high level free from crime, garbage borne diseases, illiteracy, and threats from abroad, national health care is required to keep as many members of society healthy and therefore presumably productive, as possible. the question of why society should pay to cover the health care expenses of those who have not made healthier lifestyle choices, may be answered via a two-pronged approach, both of which require not merely compassion, but a healthy dose of realism. first, i again look to those services that most americans do not mind paying for to point out that many of them are necessary due to both the ill behavior of at least some members of society, as well as the impracticality of requiring individuals who are generally ill-equipped to effectively manage various facets of their lives, to teach themselves. for example, police are needed largely because people do not always act legally or peacefully. public schools are needed, not just for the children of less affluent parents who cannot afford to send them to private or parochial schools, but for students whose parents are themselves illiterate, alcoholic, emotionally or developmentally disabled, or otherwise incapable of educating them. if this is true in these and other areas in which people are challenged and incapable, due to either irresponsibility or innate deficiency, why should it not be true in regards to the bad choices whole segments of our society make when it comes to life style? in fact, all of society will lose out, in lost productivity, prosperity, and contribution, if our government does not encourage us, through national health care, to provide health insurance for those who are less healthy than others, even if such compromised health status was caused by personal irresponsibility and neglect. the second prong of this response is that the seeming legitimacy of the question it addresses is predicated on a sense of moral superiority that is both unfortunate and indiana health law review often non-warranted. the fact is that most of us do not always do what we are supposed to, either willfully or by accident. although i am just as guilty of such misfeasance as the next person (i did not reach my present weight of 330 lbs. by eating apples and yogurt), i find it less than easy to entirely appreciate a cogent distinction between socially supportive measures many of us do not seem to mind funding, like prisons for criminals, and free contraception for the sexually irresponsible and health care for all americans, including those who are sick because of wrong choices, which care many seem to disapprove of. to be sure, there are appreciable distinctions between these examples. for example, prisoners are incarcerated to punish them for past misconduct and condoms are given to high school students to prevent them from producing unwanted children whom the government would have to support. in both such instances, however, individuals receive benefits that, due to their situation and or economic capabilities, they cannot pay for on their own. however, the basic philosophy underlying them is the same. namely, fellow human beings are in trouble and need the help, guidance, and support of others.122 the second problem many americans have with national health care is the fact that aspects of it are socialistic. 123 to 122 a fact that tends to be overlooked in health care discussions that center on objections to paying for those who are unhealthy due to bad lifestyle choices, is that such aid is designed to not contribute to sickness. to be sure, many government food programs pay for basic healthy food staples, but not deleterious items like cigarettes. see supplemental nutrition assistance program, eligible food items, usda, http://www.fns.usda.gov/snap/retailers/eligible.htm (last visited oct. 14, 2012) (showing that the supplemental nutrition assistance program may be used to purchase breads, fruits, vegetables and meat, but may not be used for alcohol or tobacco). in the same vein, government-sponsored health care, regardless of the form it takes, should encourage healthier lifestyle changes by charging so-called "sin taxes" on unhealthy items, and/or providing tax deductions, or other "rewards" to those who adopt healthier lifestyles. doing so would take a large bite out of the unhappiness many healthier americans will feel paying for insurance for those who are not as well. 123 see michael f. cannon, does barack obama support socialized medicine., cato institute (2008), http://www.cato.org/pubs/bp/ vol. 10:1106 2013 why americans have a right to national health care 107 be sure, few things arouse the ire of dedicated, loyal, and patriotic americans as easily as the implication that something is not capitalistic, never mind socialistic. this is especially true when the government is involved. we should be mindful of a few facts, however, before we address this question. first, there is a difference between socialism and communism. 124 second, socialism and 'socialized medicine' are not the same thing.125 third, although communism and capitalism are incompatible governmental systems, socialism and capitalism may be compatible and socialism and democracy are certainly compatible.126 finally, the very notion of "rights" across a broad and bpl08.pdf (describing the many critics that prefer to label president obama's health care plan "socialized medicine"); see also paul steinhauser, giuliani attacks democratic health plans as socialist, cnn.com (jul. 31, 2007), http://articles.cnn.com/2007-07-31/politics/ giuliani.democrats 1_health-care-private-health-insurance-frontrunnerin-national-polls?_s=pm:politics (stating that the democrats' proposal is un-american and socialist); see also lawrence r. huntoon, universal health coverage-call it socialized medicine, 5 med. sentinel 134 (2000), available at http://www.jpands.org/haciendal article49.html (noting the distinction between universal coverage and the delivery and practice of medicine). 124 socialism & communism explained, socialism vs. communism, http://www.socialismvscommunism.org (last visited oct. 14, 2012) (noting that socialism advocates a system of collective or government control and management of the means of production and distribution of goods whereas communism aims to eliminate private property ownership so all property may be controlled by the government and thereby remove class distinctions). 125 see paul stepansky, "socialized medicine," anyone.9 medicine, health and history (jan. 24, 2012), http://adoseofhistory.com/2012/01/ 24/socialized-medicine-anyone (discussing the confusion over the terms "socialized medicine" and "socialism"); see also robert laws, does having socialized medicine make a country socialist., helium (oct. 22, 2009), www.helium.com/items/1624475-does-having-socializedmedicine-make-a-country-socialist (noting that the adoption of a socialized medical system does not make a country socialist). 126 see socialism vs. communism, supra note 124 (noting that unlike communism, socialism can possibly exist with capitalism); see also woodrow wilson, socialism and democracy, teachingamericanhistory.org, http://teachingamericanhistory.org/ library/index.asp?document=2208 (last visited oct. 13, 2012) (noting that, in theory, socialism and democracy are compatible). indiana health law review diverse nation-wide landscape necessitates some amount of socialism, which is already practiced in the united states. to begin, although many opponents of national health care programs phrase their objections in terms of "socialized medicine," their arguments would carry more impact if they inveighed against "communistic medicine." this is because it is truly communism, and not socialism, at least limited to the matter of health care, that they seem to be protesting.127 to appreciate this, and make it easier to see why national health care is not nearly the threat its opponents would have us believe it is, realize that although both communism and socialism both cede power to the government, communism does this across the board, in all areas of social intercourse while socialism limits government control to wealth distribution and the funding of societal necessities.128 understood this way, even if national health care is viewed as a form of "socialized medicine,"129 it will not be that much of a threat to our way of life. this is partially because socialized medicine, like other manifestations of socialism, is compatible with a capitalist society like the united states. 130 the reason socialized medicine is compatible with capitalism is because a government-funded and executed health care program, like other socialized entitlements (such as police, sanitation, education, etc.), does not prevent americans from competing in a capitalistic, free-market environment to provide luxuries and a better standard of living for themselves in other areas that affect them. for example, even with government-guaranteed health coverage, americans will still need to compete in a capitalist marketplace to obtain more spacious homes, more expensive 127 see socialized medicine, conservapedia, http://www. conservapedia.com/socializedmedicine (last visited oct. 14, 2012) (noting that president reagan's opinion was that socialized medicine will completely erode the freedoms of both patients and doctors). 128 see socialism vs. communism, supra note 124. 129 see physicians for a national health program, supra note 76 (noting that socialized medicine is a system in which doctors and hospitals work for and are paid by the government). 130 see socialism vs. communism, supra note 124 ("unlike communism, socialism can exist with capitalism. . . ."). vol. 10:1108 2013 why americans have a right to national health care 109 cars and clothes, better vacations, etc. this reality takes the lie out of the misconception that capitalism is preferable to any amount of socialism because socialism, like communism, will chill incentives individuals have to work harder and be more productive. 131 in fact, a "modified capitalism" which, as a result of the socialized benefits americans already enjoy is the norm in present day america, may actually provide us with greater incentives to work and be productive. this is because, unlike members of a entirely capitalist society whose labor dollars must go to meet more of their basic needs, workers in a modified capitalist society that is paying more of those needs have that much more income at their disposal to fund a higher standard of living for themselves and their families. the awareness that their labor is helping to finance their dreams and goals, and not merely paying for essentials or increasing their employers' wealth, may motivate workers in a modified capitalistic environment to be more industrious. finally, to further render the idea of governmentsponsored health care more palatable to a greater number of people, we should differentiate between .a "right to health" and a "right to health care." the two are not synonymous. it may be that many americans are opposed to national health care because they mistakenly believe this requires them to support a right to health.132 however, proponents of national health care actually mean there is a right to health care and not a right to health, because only 131 see mark j. perry, why socialism failed, 45 the freeman 363 (1995) (noting that socialism is based on a theory that incentives don't matter); see also todd ganos, why socialism doesn't work, forbes.com (feb. 17, 2012), http://www.forbes.com/sites/toddganos/2012/02/17/why-socialism-doesntwork (noting that the socialist model removes incentives to excel). 132 module 14: the right to health, university of minnesota human rights library, http://wwwl.umn.edu/humanrts/edumat/ ihrip/circle/modules/modulel4.htm (last visited oct. 14, 2012); see also health and human rights, world health organization, www.who.int/hhr/en (statement of dr. margaret chan) ("the world needs a global health guardian . . . and a defender of health, including the right to health."). indiana health law review god or nature, and to some extent, one's own efforts, can assure the state of an individual's health.133 in fact, because so many variables including food, exercise, genetics, and luck go into determining the state of one's health, it would be absurd to speak of a "right to health." this is equally true of all other areas in which the government provides national assistance to meet the needs of its residents. for example, although the government cannot guarantee that individual americans will be safe at all times and in all locales, we, because we pay taxes, have a right to being protected by a militia.134 we do not have a right to safety. because the trajectory from idiocy to genius allows for too much of a variable in the intelligence levels of individuals, americans do not possess a right to be smart. children have a right to education. 135 this distinction is essential because a mistake in what any given right means and entails not only confuses the issue in the instant case of national health care, but obfuscates important reasons we have rights in the first place, namely the utilitarian basis of rights and society's duty to take care of those who cannot take care of themselves. 136 for example, there may be occasions in which the greatest good for the most people requires that society not favor the greatest number, as when society must protect a minority from the tyranny of the majority.137 133 see eduardo gomez, in brazil, healthcare is a right, http://www.cnn.com/2012/07/13/opinion/gomez-brazil-healthcare/index. html?iref=allsearch (last visited jan. 31, 2013). 134 u.s. const. amend. ii. 135 see federal agencies remind public schools all children have right to public education regardless of immigration status, http://www.aclu.org/immigrants-rights/federal-agencies-remind-publicschools-all-children-have-right-public-education-re (last visited jan. 31, 2013). 136 see peter wehner, the responsibility of government, http://www.commentarymagazine.com/2012/06/18/the-responsibility-ofgovernment-and-disadvantaged/#more-797147 (last visited jan. 31, 2013). 137 see direct democracy: the tyranny of the majority, the economist, (dec. 17, 2009), available at http://www.economist.com./ node/15127600 (describing how the tyranny of the majority in direct democracies can adversely impact the rights of minority groups); see 110 vol. 10:1 2013 why americans have a right to national health care 111 utilitarianism, as a political doctrine, was first advanced in modern times by jeremy bentham, a british subject, in the same year america won its revolution. in a fragment on government, bentham writes that "[ilt is the greatest happiness of the greatest number that is the measure of right and wrong."138 john stuart mill then refined jeremy bentham's thesis by adding the concept of consequentialism to it.139 under consequential utilitarianism, the happiness of the greatest number of persons is not sufficient to render an action, or course of action, correct. to qualify as correct, a course of action must result in foreseeable consequences that provide the greatest good to the greatest number of persons. 140 john stuart mill's expansion of jeremy bentham's utilitarianism then led to a communitarian liberalism, which in turn led to social democracy under which, if individuals cannot supply the means to fund their basic needs, the government must fund those needs for them. 141 social democracy has served as the political theory behind many of america's most relied on public welfare institutions, including those of the so-called "great society."142 generally the federalist no. 10, (james madison) (discussing the tyranny of the majority). 138 jeremy bentham, a fragment on government and introduction to the principles of morals and legislation 3 (wilfrid harrison ed., oxford press 1967) (1776) (emphasis omitted). 139 john stuart mill, utilitarianism 263 (mary warnock ed., world publishing company 1971) (1863) (noting in chapter two that actions are right in the proportion they tend to promote happiness and are "secured to all mankind"), available at www.utilitarianism.com/mill2.htm. 140 see philip a. pecorino, ethics -utilitarianism, http://www. qcc.cuny.edulsocialsciences/ppecorinolmedicalethicstext/chapt er_2_ethicaltraditions/utilitarianism.htm (last visited jan. 31, 2013); 141 see bodenheimer, supra note 62, at 1426-27 (noting that after mill introduced the ideal communitarian utilitarianism, liberal principles shifted to a government that was responsible to provide the greatest happiness and welfare for the greatest number of people). 142 see joseph a. califano jr., what was really great about the great society, wash. monthly (oct. 1999), available at www.washingtonmonthly.com/features/1999/9910.califano.html (noting that the efforts of the great society included head start, medicare and medicaid programs, and civil rights, clean air and water acts). indiana health law review national health care may be said, therefore, to be both overtly and implicitly mandated by the constitution, and other founding documents of the united states, and sanctioned by numerous political and philosophical theories. also, it does not violate the democratic or capitalistic foundations this country was built on. likewise, the idea of a universal, government-funded and realized health care program is also understood to be a fundamental right by organizations, associations, and thinkers who are not limited either by american political or constitutional thought, or a particular political philosophy. to begin, the universal declaration of human rights states that "[elveryone has the right to . . . medical care," 143 and the international covenant on economic, social and cultural rights requires, "[t]he creation of conditions which would assure to all medical service and medical attention in the event of sickness."144 many scholars also believe, premised on legal, political, philosophical, and moral grounds, that health care is a human right that must be made available to all, irrespective of an individual's ability to pay for it.145 three examples of 143 the universal declaration of human rights, g.a. res. 217 (iii) a, art. 25, u.n. doc. a/res/217(iii) (dec. 10, 1948), available at www.un.org/en/documents/udhr. 144 international covenant on economic, social and cultural rights, g.a. res. 2200 (xxi), art. 12, u.n. gaor, 21 sess., supp. no 16, doc. a/6316 (1967) reprinted in 6 i.l.m. 360 (1967) (entered into force jan. 3, 1976), available at www2.ohchr.org/englishflaw/cescr.htm. 145 see julian sanchez, ronald dworkin, heartless libertarian., julian sanchez (sept, 21, 2011), http://www.juliansanchez.com/ 2011/09/21/ronald-dworkin-heartless-libertarian ("unsurprisingly, [dworkin] favors a national system of universal healthcare."); see also richard rorty, looking back, looking forward, the nation (dec. 20, 2004), available at http://www.thenation.com/article/looking-backlooking-forward?page=0,5 (noting the "humiliation and misery of families without health insurance"); see also robert w. tabscott, moral man, immoral society: reinhold niebuhr, st. louis journalism rev. (may 1, 2009), available at http://www.thefreelibrary.com/moral+man,+ immoral+society%3a+rheinhold+niebuhr.-a0204683633) (noting that reinhold neibuhr advocated for health care for assembly line workers); see also thomas j. papadimos, healthcare access as a right, not a privilege: a construct of western thought, phil., ethics, and human. in med. (march 28, 2007), http://www.peh-med.com/content/pdf/1747112 vol. 10:1 2013 why americans have a right to national health care 113 an argument in favor of universal health care that can be extrapolated from the thought of important philosophers are meng tzu's ideal of adequate social welfare, the categorical imperative of immanuel kant, and the theory of justice by john rawls. meng tzu advocates a theory of social welfare in which the "ruler" (government) is considerate of the needs of his subjects.146 this is true even when society is confronted with conflicting and competing interests.147 in an example provided by meng tzu, a student and teacher must engage in combat. the student faces a conflict of interest, for on the one hand he is duty-bound to destroy his teacher who is his political enemy. on the other hand, he should spare his teacher out of respect. meng tzu's solution is to have the student disarm his arrows, and then shoot them at his teacher. 148 for meng tzu this is an acceptable solution because the student compromises the imperative to kill his teacher by doctoring his weapons so they cannot harm him, 5341-2-2.pdf ("[ilnequalities [in health care] will be tolerated only when such inequalities work to the advantage of society's most disadvantaged."); see also jill jacobs, health care reflects a jewish obligation, jewish week (sept. 2009), (advocating that when poor people cannot pay for their medical care, the community sends a doctor and the medicine is paid for by a communal fund); see also james hughes, buddhist bioethics, in principles of health care ethics 131-32 (r.e. ashcroft, a. dawson, h. draper, & j.r. mcmillan eds., 2nd ed., john wiley & sons, 2007), available at http://ieet.org/archive/buddhistbioethics.pdf, see also stephen foley, tony judt: i am not pessimistic in the very long run, the independent (u.k.) (march 24, 2010), available at http://www. independent.co.uklarts-entertainment/books/features/tony-judt-i-amnot-pessimistic-in-the-very-long-run1925966.html (stating that "healthcare reform is . . . self-evidently necessary"); see also bhfrik, happy birthday stephen hawking, daily kos (jan. 8, 2012), http:// www.dailykos.com/story/2012/01/09/1052896/-happy-birthday-stephenhawking ("[stephen hawking] wouldn't be here today if it were it not for the n.h.s."); see also e-mail from joseph raz, research professor, king's college london (feb. 24, 2012, 11:53 am est) (on file with author) ("[healthcare] is a recognized human right, well entrenched in international law."). 146 see meng-tzu in masterpieces of world philosophy 89 (frank n. magill ed., 1990). 147 see id. at 91-92. 148 see id. at 91. indiana health law review but still shoots them at him as a symbolic gesture of his teacher's status as his political enemy. in this way, the student, perhaps as a representative of the government, is able to balance two legitimate state interests. the first interest is the need for members of society to respect its teachers, while the second is the need for society to protect itself from enemies. the relevancy of meng tzu's thesis to national health care is unmistakable. many americans believe the debate on national health care is insurmountable due to the friction such health care would create between the right of all americans to health care, and the seemingly competing right americans have to be free from government intrusion over their choice of health care. 149 meng tzu's hypothetical student's solution, being able to both honor his teacher and fight his enemy, can inform a compromise that would be the modified capitalistic american society i favor. specifically, members in such a society would have their basic needs socialistically met, while still being able to work capitalistically for luxuries and a higher standard of living. second, kant's categorical imperative is essentially a philosophical reformulation of the golden rule. 150 whereas the golden rule calls on one to not do anything she doesn't want anyone else to do to her, the categorical imperative posits one should not do anything she does not want anyone to do to anyone else.151 clearly this maxim provides a legitimate rationale for universal health care because although some healthy and affluent individuals may not favor paying for the care of others, in the event such persons were to become sick and impoverished and unable to pay 149 see megan argo, health care: caught between head and heart, ethical spectacle (sept. 2009), http://www.spectacle.org/0909/ argo.html. 150 see generally thelma z. lavine, reasonable doubt, washington post, may 20, 2001, at 13, available at http://www.tjhsst. edul-jlamblkant-%20bio.pdf. (reviewing kant: a biography). 151 see philip a. pecorino, ethics -the categorical imperative, http://www.qcc.cuny.edu/socialsciences/ppecorino/introtext/chapter%20 8%2oethics/categoricalimperative.htm (last visited jan. 31, 2013); see also foundations of the metaphysics of morals, in masterpieces of world philosophy 336-43 (frank n. magill ed. 1990). vol. 10:1114 2013 why americans have a right to national health care 115 their medical bills, they might very well change their minds and favor national coverage.152 such a dynamic proves that the position of many opponents of national health care is untenable, even on their own terms, for many, if not most, such persons would truly not wish to be without access to health care in the event they could not pay for it. this provides the kantian ground for why a program of national health care is reasonable. in a theory of justice, rawls presents his difference principle, that in a just and fair society, individuals choose to live so that any advantage they collectively have does not infringe on the interests of the least advantaged among them.153 all examinations of health care under a rawlsian analysis must therefore yield a system that, like government-executed health care, is accessible to all individuals, regardless of ability to pay, because to insist on the private insurance set up presently in place, would advantage those who can independently finance their health care over those who cannot. viii. conclusion a cogent reading of key constitutional provisions including the preamble and the commerce, equal protection, and due process clauses, as well as the articles of confederation and the declaration of independence, informs that americans have a right to national, government-sponsored health care. such a right to national health care is also supported by international constitutions and declarations and time-honored philosophical positions, 152 see generally papadimos, supra note 140 (noting that the question of health care access for all persons is a moral interrogative that is "always there," especially as some who do not feel they need it today may very well need it tomorrow and that "we feel [the power of morality] even when we are most defying it . .. [and is] a compelling dictate that can be ignored, but never refuted"). 153 theory of justice, in masterpieces of world philosophy 678; the difference principle, political philosophy.info, http://www. politicalphilosophy.info/differenceprinciple.html (last visited oct. 14, 2012). indiana health law review such as are found in utilitarianism, the categorical imperative, rawls' theory of justice, and legal realism. that all americans and indeed citizens of the civilized world have a right to health care, irrespective of their ability to pay for insurance, is further guided by the fact that most europeans and canadians and many asians presently have such access, and americans already enjoy many essentially socialized government benefits, from police protection and sanitation services to public education. finally, the history of health care in this country suggests an evolutionary trajectory from no insurance to private insurance to partially subsidized health care, 154 as reflected in the gradually controlling patient protection and affordability care act,156 a program that the supreme court has recently held constitutional.1 5 6 this evolution in health care is both encouraging and welcome because it demonstrates a growing and maturing understanding that morality and human rights are enmeshed with social responsibility. in fact, through this evolution, society has begun to fulfill a dynamic that the moral philosopher marc hauser notes at the individual level and calls a "norm of social responsibility," which is to "[h]elp people who can't help themselves."1 57 154 see stay smart: stay healthy, supra note 23. 155 see supra notes 44-48. 156 see nat'l fed'n of indep. bus. v. sebelius, 132 s. ct. 2566 (2012). 157 marc. d. hauser, moral minds 289 (2006). 116 vol. 10:1 microsoft word 1-volume xii masthead.docx supporting the rationale behind the hatchwaxman act and patent law: how reverse payment settlements under ftc v. actavis, inc. can be procompetitive andrew e. podgorny* i. introduction .................................................................. 424 a. the issue ..................................................................... 426 b. roadmap ..................................................................... 428 ii. background information ........................................... 428 a. pre-hatch-waxman act ............................................. 428 b. the hatch-waxman act: a compromise for pioneer and generic manufacturers ...................................... 430 c. the hatch-waxman act and reverse payment settlements ................................................................ 432 d. alternative methods to analyze reverse payment settlements ................................................................ 434 1. the third circuit: the quick look rule of reason ... 436 2. the eleventh circuit: scope of patent test ............. 436 e. the circuit split and supreme court decision ........ 437 1. in re k-dur antitrust litigation .............................. 437 2. ftc v. watson pharmaceuticals inc. ....................... 439 3. ftc v. actavis, inc. ................................................... 440 f. what is the rule of reason? ....................................... 442 g. congress addresses reverse payment settlements ... 443 iii. analysis: the residual effect of actavis and importance of crafting pro-competitive settlements ................................................................. 444 a. impact of using rule of reason analysis .................. 444 1. effect of antitrust laws: how consumers benefit .. 444 2. effect of antitrust laws: different affect on drug manufacturers ............................................................... 449 b. complying with the actavis framework: crafting procompetitive reverse payment settlements ........ 452 * j.d. candidate, 2015, indiana university robert h. mckinney school of law; b.s., 2011, indiana university-bloomington. http://dx.doi.org/10.18060/18967 424 indiana health law review vol. 12:1 1. what type of payments implicate the actavis analysis ......................................................................... 453 2. market power ............................................................ 454 3. relevant market ........................................................ 455 4. redeeming virtues .................................................... 456 5. size of monetary payments ...................................... 458 6. time frame for generic entry ................................. 461 7. strength of patent ..................................................... 462 8. venue ......................................................................... 463 9. ability to explain ...................................................... 464 iv. policy recommendation: how reverse payment settlements support the intent of patent law and the hatch-waxman act .............................................. 464 v. conclusion .................................................................... 468 i. introduction john’s family has come to visit him at the nursing home. his grandchildren, bursting with excitement, come running into the room and jump up to hug their grandfather, only to be greeted with, “who might you be?” john suffers from alzheimer’s disease, which causes him memory loss and also affects his intellectual abilities used in daily life.1 alzheimer’s disease is one of many known ailments that has continued to perplex scientists for over a century and, to this day, has no cure. abc corporation (“abc”) is attempting to develop a new drug that will revolutionize medical treatment for people suffering from alzheimer’s disease. abc’s main business includes research, development, and marketing of new pharmaceutical drugs. recently, due in large part to complex research and numerous clinical trials, abc has poured millions of dollars and years of research into drug 23. dr. white, the lead scientist for drug 23, claims that if 1 see alzheimer’s ass’n, what is alzheimer’s?, alz.org, https://www.alz.org/alzheimers_disease_what_is_alzheimers.asp (last visited mar. 8, 2014). 2015 rationale behind hatch-waxman act and patent law 425 abc is successful in its development of drug 23, its scientists will have developed a cure for alzheimer’s disease. while abc is taking a huge risk by expending a large amount of resources into a drug that may or may not pay any dividends, that risk is worthwhile because of the potential benefit to society and the financial windfall abc will gain from the right to legally sell the drug at a monopolistic price2 by virtue of obtaining a patent. after years of painstaking effort and near bankruptcy for abc, drug 23 has come to fruition. drug 23 has accomplished exactly what it set out to do, cure alzheimer’s disease. wanting to sell its product, abc, the pioneer manufacturer, files a new drug application3 (“nda”) with the food and drug administration (“fda”). thereafter, abc receives approval from the fda and begins marketing drug 23. abc’s stock price skyrockets, mostly due to a large uptick in revenue and profit resulting from drug 23 being sold at a monopolistic price. a few years down the line, xyz corporation (“xyz”) plans to bring drug 70 to the market, a drug equivalent to abc’s drug 23. xyz does not develop new drugs like abc; instead, xyz focuses its business on bringing generic equivalents to the market. in order to be able to sell drug 70, xyz, the generic manufacturer, files an abbreviated new drug application4 (“anda”) with the fda certifying that abc’s patent is either invalid or will not be infringed by xyz.5 this process of certification is necessary to show that xyz will not infringe the patent granted to abc.6 as a result of xyz’s anda filing, litigation ensues. abc files suit against xyz alleging drug 70 will infringe its patent covering drug 23. realizing that it is in neither company’s 2 a patent grants the patentee monopolistic control in a given market. times-picayune pub. co. v. united states, 345 u.s. 594, 608 (1953). however, control granted by a patent is limited to “the literal scope of the patent claims.” dawson chem. co. v. rohm and haas co., 448 u.s. 176, 221 (1980). therefore, as long as the patentee is within the scope of the patent, they can legally charge a monopolistic price. 3 see discussion infra section ii.c. 4 see discussion infra section ii.c. 5 see 21 u.s.c. § 355(j)(2)(a)(vii)(iv) (2015) (paragraph iv route). 6 21 u.s.c. § 355(j)(2)(a)(vii) (2015). 426 indiana health law review vol. 12:1 best interest to be involved in a prolonged legal battle, abc and xyz amicably settle before trial begins. the relevant terms of the settlement agreement are as follows: 1. abc voluntarily agrees to dismiss the patent infringement suit against xyz. 2. abc shall pay xyz the sum of $10,000,000.00 per year for the remaining term of the patent7 on drug 23. 3. as consideration, xyz will refrain from bringing to market drug 70 until the patent on drug 23 has expired. 4. xyz will provide marketing services in regards to abc’s drug 23. said marketing services will be comprised of promoting abc’s drug 23 to physicians. this type of settlement agreement is known as a reverse payment settlement. the name derives from a defendant in a patent infringement suit receiving something of value, as compared to a normal lawsuit where the plaintiff would receive something of value. in the example above, abc brought the infringement suit against xyz, but in the end, xyz was the one who received a monetary payment. a. the issue a large contributing factor to the growing cost of health care in the united states involves the rising cost of prescription drugs.8 critics argue that reverse payment settlements increase the cost of drugs by delaying generic drug entry into the market.9 also, some have criticized reverse payment settlements as anticompetitive.10 on the other hand, it can be argued that reverse payment settlements are necessary to protect patents which provide 7 see infra note 35. 8 see u.s. census bureau, statistical abstract of the united states: national health expenditures (2012) (showing total national health care expenditures increased from $1,286,800,000,000 in 1999 to $2,486,300,000,000 in 2009) [hereinafter 2012 census]. 9 pay-for-delay: how drug company pay-offs cost consumers billions, fed. trade commission (2010), http://www.ftc.gov/ sites/default/files/documents/reports/pay-delay-how-drug-company-payoffs-cost-consumers-billions-federal-trade-commission-staffstudy/100112payfordelayrpt.pdf [hereinafter pay-for-delay]. 10 id. 2015 rationale behind hatch-waxman act and patent law 427 incentives11 to drug manufacturers to take the risks associated with developing new drugs.12 in recent years, the federal trade commission (“ftc”) has brought numerous lawsuits in an attempt to have a court hold reverse payment settlements illegal due to their anticompetitive effect.13 in late 2012, the supreme court granted certiorari in order to resolve a circuit split regarding the proper analysis for determining whether a reverse payment settlement is anticompetitive.14 the current issue arises as the court took a middle ground by holding that the rule of reason,15 a standard borrowed from antitrust law, was applicable to reverse payment settlements. in addition, congressional action16 on the horizon potentially conflicts with the court’s opinion. given that actavis was handed down june 17, 2013, its impact is still not fully realized. however, as will be demonstrated in this note, although the court has provided little guidance for drug manufacturers, district courts, and the ftc, the rule of reason is a sound choice as it resonates with fundamental and important rationales behind patent law and the hatch-waxman act. 11 see rebecca s. eisenberg, patents and the progress of science: exclusive rights and experimental use, 56 u. chi. l. rev. 1017, 102437 (1989) (discussing theories of justification for monopolies created by patents). 12 matthew herper, the truly staggering cost of inventing new drugs, forbes (feb. 10, 2012, 7:41 am), http://www.forbes.com/ sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventingnew-drugs/. the author notes the cost of research and development, while it varies manufacturer to manufacture, is astronomical. in 2011, on average, astrazeneca spent $11.79 billion, roche spent $7.8 billion, pfizer spent $7.72 billion, and eli lilly spent $4.57 billion on research and development per drug. 13 e.g., ftc v. watson pharms., inc., 677 f.3d 1298 (11th cir. 2012), rev’d sub nom. ftc v. actavis, inc., 133 s. ct. 2223 (2013); scheringplough corp. v. f.t.c., 402 f.3d 1056 (11th cir. 2005). 14 watson pharms., 677 f.3d 1298, cert. granted, 81 u.s.l.w. 3216 (u.s. dec. 7, 2012) (no. 12-416). 15 actavis, 133 s. ct. at 2237. 16 see preserve access to affordable generics act, s. 214, 113th cong. (2013) (introduced to the senate on feb. 4, 2013 and held hearings on july 23, 2013) (establishing a presumption that reverse payment settlements are anticompetitive). http://dx.doi.org/10.2307/1599761 428 indiana health law review vol. 12:1 b. roadmap the court’s application of rule of reason analysis was correct and should not be changed by congress.17 the court’s opinion did not prohibit reverse payment settlements per se and in doing so the court outlined a brief framework for analyzing reverse payment settlements under the rule of reason. this note addresses the impact of using the rule of reason, what courts will look at, under actavis, to determine if a reverse payment settlement is pro-competitive, and why the rule of reason was the correct choice for analysis. in order to facilitate a better understanding of reverse payment settlements and recent common law, section ii begins by providing background information about the hatch-waxman act and its application to reverse payment settlements. additionally, section ii provides information on the existing state of common law pre-actavis, a brief overview of the rule of reason, and an overview of recent congressional action. section iii discusses how actavis will benefit consumers and may cause a slight burden for manufactures. next, section iii provides a solution for crafting a pro-competitive reverse payment settlement under actavis. finally, section iv discusses a policy recommendation concerning potential congressional action in regards to reverse payment settlements. ii. background information a. pre-hatch-waxman act on june 25, 1938 the federal food, drug, and cosmetics act (“fdca”) was signed into law.18 the fdca, for the first 17 contra brianna ford, using reverse payment agreements as an effective way to maintain a patent monopoly in the pharmaceutical industry, 21 am. u. j. gender soc. pol’y & l. 919, 949 (2013) (arguing for congress to ban reverse payment settlements). 18 federal food, drug, and cosmetics act, pub. l. no. 75-717, 52 stat. 1040 (1938) (codified as amended at 21 u.s.c. §§ 301-399f (2015)). 2015 rationale behind hatch-waxman act and patent law 429 time, empowered the fda to review the safety of new drugs.19 before 1962, drugs were only approved for safety without any form of an efficacy requirement.20 this would mean that in the earlier example, drug 23 developed by abc before 1962, would be approvable without proof of improving a consumer’s memory or other intellectual abilities. in 1962, an amendment to fdca added “a proofof-efficacy requirement [for] new drug approval[s].”21 subsequently, after 1962, a manufacturer was required to “demonstrate not only the safety of the drug, but that it was effective for its intended use.”22 after 1962, generic drugs generally entered the market through an abbreviated approval process23 or through “paper”24 new drug applications.25 however, neither the abbreviated approval process nor the “paper” new drug application had a large effect on generic drugs entering the market. the abbreviated approval process had a minimal effect, because it only applied to drugs approved prior to 1962.26 also, the paper-nda had little effect because of the lack of publically available information on safety and 19 elizabeth stotland weiswasser & scott d. danzis, the hatchwaxman act: history, structure, and legacy, 71 antitrust l.j. 585, 587 (2003). 20 gerald j. mossinghoff, overview of the hatch-waxman act and its impact on the drug development process, 54 food & drug l.j. 187, 187 (1999). 21 id. (discussing the thalidomide problem in infants led to adding a proof-of-efficacy requirement); see also russell mokhiber, the tragic children of thalidomide, 8 multinational monitor 4, 4 (1987) (discussing how pregnant mothers in the 1950s and early 1960s took the drug thalidomide which caused deformities in babies). 22 weiswasser & danzis, supra note 19, at 588. 23 id. (discussing how this process only applied to drugs which were approved prior to 1962 and reviewed through the drug efficacy study implementation). 24 see mossinghoff, supra note 20 (discussing how the term paper arose because only published scientific or medical literature was used to approve the nda). 25 weiswasser & danzis, supra note 19, at 589 (explaining how drugs were approved based on publically available data declaring the drug’s safety and effectiveness). 26 id. 430 indiana health law review vol. 12:1 effectiveness for drugs.27 this resulted in congressional testimony in 1984 stating “there were 150 drugs that were off-patent, but for which there were no generics because generic companies simply would not spend the time and money doing the clinical trial[s] to get to market, and that there were only fifteen ‘paper ndas,’ for post-1962 generics.”28 b. the hatch-waxman act: a compromise for pioneer and generic manufacturers the drug price competition and patent term restoration act of 1984, commonly known as the hatchwaxman act, was enacted to revise the procedures for filing a nda under the fdca.29 the hatch-waxman act attempts to “strike a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.”30 furthermore, in bringing low-cost drugs to the market, it will allow access to certain drugs for consumers who might not otherwise be able to obtain them. public policy support for generic drugs often conflicts with patent law’s justifications for granting monopolistic power to the patentee.31 in order to induce pioneer research and development, congress desired for pioneer manufacturers to receive a patent term extension.32 as the house reported in 1984, pharmaceutical manufacturers 27 id. 28 mossinghoff, supra note 20 (citing h.r. rep. no. 98-857, pt. 1 (1984). 29 drug price competition and patent term restoration act of 1984, pub. l. no. 98-417, 98 stat. 1585 (1984). 30 caraco pharm. labs., ltd. v. forest labs., inc. 527 f.3d 1278, 1282 (fed. cir. 2008) (quoting andrx pharms., inc. v. biovail corp., 276 f.3d 1368, 1371 (fed. cir. 2002)). 31 eisenberg, supra note 11. generally, public policy in favor of bringing lower cost drugs in a more timely fashion to market is the hallmark behind generic drugs. id. meanwhile, the justification for a monopoly created by a patent can be seen as an “incentive to invent,” “incentive to disclose,” and an incentive to “invest in innovation.” id. 32 h.r. rep. no. 98-857, at 15 (1984). 2015 rationale behind hatch-waxman act and patent law 431 testified that “the average effective patent term of drugs has declined”33 as a result of government review.34 congress attempted to return this lost time through a “restoration of some of the time lost on patent life while the product is awaiting pre-market approval.”35 this restored patent life is “equal to the regulatory review period for the approved product which period occurs after the date the patent is issued.”36 this period is subject to a number of limitations, but as a general matter is one-half the length of time between the effective date of the investigational new drug application (ind)–an application allowing a drug sponsor to advance from preclinical to clinical trials–and submission of the nda, plus the length of time between filing and approval of the nda, up to a total of five years.37 lastly, the term of the patent after the date of approval plus the period of extension will be adjusted so it does not exceed fourteen years from the date of approval.38 these adjustments satisfy congress’ intent to return lost time while the drug is being approved. in order to improve the amount of generic equivalents on the market, the act “relax[es] the testing requirements imposed on generic manufacturers and allow[s] them to piggyback on data developed by the pioneer [manufacturer].”39 specifically, the new procedure for an anda allows “generic copies of any drugs [to] be approved if the generic is the same as the original drug or so similar 33 id. at 17-18 34 fact sheet: new drug development process, cal. biomedical res. ass’n, http://ca-biomed.org/pdf/media-kit/fact-sheets/ cbradrugdevelop.pdf (last visited sept. 8, 2014). patent terms are for twenty years beginning on the date the patent is issued. 35 u.s.c. §154(a)(2). id. however, the effective patent term must be viewed based on the time in which a drug is available for purchase by consumers. id. on average, it takes “12 years for a drug to travel from the research lab to the [consumer].” id. subsequently, on average, a new drug only has an effective patent term of 8 years. 35 h.r. rep. no. 98-857, at 15 (1984). 36 35 u.s.c. §156(c) (2015). 37 weiswasser & danzis, supra note 19, at 591. 38 35 u.s.c. §156(c)(3) (2015). 39 weiswasser & danzis, supra note 19, at 590. 432 indiana health law review vol. 12:1 that fda has determined the differences do not require safety and effectiveness testing.”40 c. the hatch-waxman act and reverse payment settlements reverse payment settlements are “[p]ayments pursuant to the settlement of a patent [infringement] suit [which flow from the patent holder to the alleged infringer] . . . by contrast, ‘[t]ypically, in patent infringement cases the payment flows from the alleged infringer to the patent holder.’”41 in the context of reverse payment settlements, there are four key features of the hatch-waxman act.42 first, a drug manufacturer who develops a new prescription drug must file a nda with the fda.43 after receiving approval, a drug manufacturer will generally file a patent application with the patent and trademark officer.44 40 h.r. rep. no. 98-857, at 14-15 (1984) (explaining how the new anda process provides for “piggybacking” off of new pioneer drugs that are submitted after 1962). 41 in re tamoxifen citrate antitrust litig., 466 f.3d 187, 205 (2d cir. 2005) (quoting david a. balto, pharmaceutical patent settlements: the antitrust risks, 55 food & drug l.j. 321, 335 (2000)), abrogated by f.t.c. v. actavis, inc., 133 s. ct. 2223 (2013). 42 actavis, 133 s. ct. at 2227. 43 21 u.s.c. § 355(b)(1) (2015) (requiring the following for a nda: safety and effectiveness reports; components of the drug; composition of the drug; “description of methods used in, facilities and controls used for, the manufacture, processing and packing of drug”; samples and articles of components as required by the secretary; “specimens of the labeling proposed”; “any assessments required under section 355(c)”; and “[t]he applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug”). 44 obtaining a patent is desirable because it can be used to “invoke the state’s power to prevent others from utilizing [one’s] discovery without [their] consent.” united states v. westinghouse elec. corp., 648 f.2d 642, 647 (9th cir. 1981). in the united states, patents are issued by the united states patent and trademark office. general information concerning patents, uspto.gov, http://www.uspto.gov/ patents/resources/general_info_concerning_patents.jsp#heading-1 (last 2015 rationale behind hatch-waxman act and patent law 433 thereafter, the fda lists patents from ndas in the publication “approved drug products with therapeutic equivalence evaluations.”45 frequently, this publication is referred to as “the orange book.”46 second, after the fda has approved a pioneer drug, a generic manufacturer can file an anda.47 using an anda allows the generic manufacturer to piggyback off the pioneer manufacturer and avoid duplicate testing.48 however, if the pioneer drug includes a new active updated oct. 2014). generally, there are three types: utility patents (the general “all purpose” patent), design patents (article of manufacture), and plant patents (new plant variety). patents, uspto.gov, http://www.uspto.gov/patents/ (last visited mar. 8, 2014). obtaining a patent involves many steps, such as: determining patentability, filing strategy, domestic v. international protection and examination. see generally process for obtaining a utility patent, uspto.gov, http://www.uspto.gov/patents/process/index.jsp?utm_source=feedburner &utm_medium=twitter&utm_campaign=feed%3a+hackernewsyc+(hac ker+news+yc) (last visited mar. 8, 2014). lastly, the term of a patent begins when the patent is issued and ends “20 years from the date on which the application for the patent was filed,” unless “the application contain a specific reference to an earlier filed application . . . [then] from the date on which the earliest such application was filed.” 35 u.s.c. § 154(a)(2) (2015). 45 caraco pharm. labs., ltd. v. forest labs., inc. 527 f.3d 1278, 1282 (fed. cir. 2008). 46 id.; see also approved drug products with therapeutic equivalence evaluations (orange book), u.s. food & drug admin., http://www.fda.gov/drugs/informationondrugs/ucm129662.htm (last visited mar. 8, 2014). 47 21 u.s.c. § 355(j) (2015). 48 for example, in 2011, the branded cholesterol-lowering drug lipitor came off patent and generic versions were available under the name atorvastatin. daniel j. denoon, lipitor goes generic: what it means for you, webmd (nov. 29, 2011), http://www.webmd.com/cholesterolmanagement/news/20111129/faq-generic-lipitor. in a letter from keith webber, deputy director for the office of pharmaceutical science, to ranbaxy laboratories, generic lipitor manufacturer, webber notes how ranbaxy’s anda for their atorvastatin tablets are approved as they were found “to be bioequivalent and, therefore, therapeutically equivalent” to lipitor tablets. letter from keith webber, deputy director, office of pharmaceutical science, to scott d. tomsky, senior manage, regulatory affairs (2011) (on file with author), available at http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076477orig 1s000ltr.pdf. 434 indiana health law review vol. 12:1 ingredient, which has not been previously approved in any other application, an anda cannot be filed until “the expiration of four years from the date of the approval.”49 third, in order to avoid patent infringement, the generic manufacture must provide a certification that the generic drug will not infringe the patent of the pioneer drug.50 the generic manufacturer can certify (1) “that such patent information has not been filed;” (2) that such patent has expired;” (3) “the date on which such patent will expire;” or (4) “that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.”51 the fourth option, known as the paragraph iv route, is enticing to generic manufacturers as it will often allow generic manufacturers to bring its product to the market sooner than under the other three routes. in order to provide some protection, under the paragraph iv route a pioneer manufacturer has 45 days to bring an infringement suit.52 fourth, a generic manufacturer who is first to file an anda under the paragraph iv route is entitled to an exclusivity period of 180 days after the date of the first commercial marketing of the drug.53 d. alternative methods to analyze reverse payment settlements generic manufacturers frequently certify under the paragraph iv route. in order to counter this certification, the pioneer manufacturer will bring suit against the generic manufacture alleging patent infringement. in the context of this note, these suits are resolved through a reverse payment settlement instead of litigating the infringement suit in a court of law. while settlements are generally 49 21 u.s.c. § 355(j)(5)(f)(ii) (2015). 50 id. § 355(j)(2)(a)(vii). 51 id. § 355(j)(2)(a)(vii)(i)-(iv). 52 id. § 355(j)(5)(b)(iii) (stating further that if an infringement suit is brought, the fda must withhold approval of the generic drug for a period of 30 months). 53 id. § 355(j)(5)(b)(iv)(i). 2015 rationale behind hatch-waxman act and patent law 435 favored, the ftc has issue with these reverse payment settlements because, in its eyes, they are anticompetitive.54 before actavis, federal courts were split on whether antitrust or patent law applied to reverse payment settlements under the hatch-waxman act.55 however, initially, due to binding and favorable precedent in the eleventh circuit, pharmaceutical manufacturers would generally appeal ftc final orders in its jurisdiction.56 this allowed pharmaceutical manufacturers to prevent another circuit from creating a circuit split, and in turn make the issue appealable to the supreme court.57 eventually, a group of wholesalers and retailers brought a suit involving reverse payment settlements in the third circuit.58 subsequently, the third circuit’s decision in in re 54 see pay-for-delay, supra note 9 (explaining how reverse payment settlements “have significantly postponed substantial consumer savings from lower generic prices”). 55 compare in re ciprofloxacin hydrochloride antitrust litig., 544 f.3d 1323, 1336 (fed. cir. 2008) (inquiry is whether the agreement exceeded the exclusionary zone of the patent), abrogated by ftc v. actavis, inc., 133 s. ct. 2223 (2013); in re tamoxifen citrate antitrust litig., 466 f.3d 187, 212-13 (2d cir. 2006) (immune from antitrust attack as long as settlement does not exceed scope of patent), abrogated by actavis, 133 s. ct. 2223; valley drug co. v. geneva pharms., inc., 344 f.3d 1294, 1311 (11th cir. 2003) (a reverse payment settlement does not demonstrate a settlement is anticompetitive), with in re k-dur antitrust litig., 686 f. 3d 197, 218 (3d cir. 2012) (presumably an unreasonable restraint on trade), vacated, actavis, 133 s. ct. 2223, and in re cardizem cd antitrust litig., 332 f.3d 896, 908 (6th cir. 2003) (reverse payment delaying 180 day exclusivity period was a horizontal restraint of trade, which are deemed per se illegal restraints on trade); andrx pharms., inc. v. biovail corp. int’l, 256 f.3d 799, 813 (d.c. cir. 2001) (agreement to maintain the status quo until end of infringement suit “harms consumers by slowing the introduction of lower priced products into the market”). 56 see 15 u.s.c. § 45(c) (2015) (“any person, partnership, or corporation required by an order of the [ftc] to cease and desist from using any method of competition or act or practice may obtain a review of such order in the court of appeals of the united states, within any circuit where the method of competition or the act or practice in question was used or where such person, partnership, or corporation resides or carries on business . . . .”) (emphasis added). 57 see sup. ct. r. 10. 58 in re k-dur, 686 f.3d at 207. 436 indiana health law review vol. 12:1 k-dur antitrust litigation created a circuit split with the eleventh circuit’s decision in ftc v. watson pharmaceuticals. 1. the third circuit: the quick look rule of reason test the third circuit applied a “quick look” rule of reason analysis.59 in doing so, the third circuit held that reverse payment settlements were “prima facie evidence of an unreasonable restraint of trade . . . .”60 this presumption can be “rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some procompetitive benefit.”61 based on the presumption of anticompetitive harm, the majority, if not all, reverse payment settlements would be struck down and as a result contradict incentives provided by patent law. 2. the eleventh circuit: scope of patent test conversely, the eleventh circuit applied a scope of patent test.62 the eleventh circuit holds that “absent sham litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent.”63 the key is the potential exclusionary power of a patent, not the actual power. for example, a patent issued for a drug has the potential exclusionary power to exclude all similar drugs. however, at the same time, said patent may not have any 59 id. at 218. 60 id. 61 id. (stating that a procompetitive benefit may be “a modest cash payment that enables a cash-starved generic manufacture to avoid bankruptcy and begin marketing a generic drug”). 62 see also in re ciprofloxacin hydrochloride antitrust litig., 544 f.3d 1323, 1336 (fed. cir. 2008), abrogated by f.t.c. v. actavis, inc., 133 s. ct. 2223 (2013); in re tamoxifen citrate antitrust litig., 466 f.3d 187, 212-13 (2d cir. 2006), abrogated by actavis, 133 s. ct. 2223. 63 ftc v. watson pharms. inc., 677 f.3d 1298, 1312 (11th cir. 2012), rev’d sub nom. actavis, 133 s. ct. 2223. 2015 rationale behind hatch-waxman act and patent law 437 actual power if a court invalidates the patent. consequently, “actual power” takes into account the validity of the patent while “potential exclusionary power” assumes validity. this leads to the conclusion that “a court judgment about a patent’s actual exclusionary power, unless that judgment comes before settlement, does not count.”64 the general policy rationale behind the scope of patent test is one of favoring settlement.65 the eleventh circuit has specifically noted the high stakes nature of patent litigation and that “parties settle to cap the cost of litigation and to avoid the chance of losing.”66 e. the circuit split and supreme court decision 1. in re k-dur antitrust litigation67 schering-plough corporation (“schering”) obtained the ‘743 patent on september 5, 1989 for its drug k-dur.68 thereafter, two generic manufacturers, upsher and esi, filed an anda, with a paragraph iv certification alleging that it would not infringe schering’s ‘743 patent.69 as a result, schering brought a patent infringement suit.70 schering settled with both generic manufactures before a trial occurred.71 first, schering’s settlement with upsher provided that: (a) upsher would refrain from marketing its generic product until september 1, 2001, when it would receive a non-royalty non-exclusive license under the ‘743 patent; (b) upsher would grant schering various licenses for products which upsher developed; and (c) schering was to 64 id. at 1308 (quoting valley drug co. v. geneva pharms., inc., 344 f.3d 1294, 1311 (11th cir. 2003)). 65 see id. at 1313. 66 id. (comparing a party who is likely to win patent litigation to a person who is likely to win a game of russian roulette, but still not willing to take the chance). 67 in re k-dur antitrust litig., 686 f. 3d 197 (3d cir. 2012), vacated, actavis, 133 s. ct. 2223. 68 id. at 205. 69 id. at 205-06 70 id. 71 id. 438 indiana health law review vol. 12:1 pay upsher $60,000,000 over three years and other amounts based on the sales of the products licensed to schering.72 second, schering’s settlement with esi provided that: (a) esi would receive a royalty-free license under the ‘743 patent beginning on january 1, 2004; (b) schering paid esi $5,000,000 up front; and (c) schering would pay esi additional compensation based on when esi’s anda was approved by the fda.73 the ftc filed a complaint against schering, upsher, and esi alleging the settlements unreasonably restrained commerce.74 in addition, forty-four wholesalers and retailers who purchased k-dur from schering brought suit and were certified as a class of plaintiffs.75 the district court adopted the report and recommendation of a special master which applied the scope of patent test (a reverse payment settlement is valid as long as it falls within the potential exclusionary effect of the patent) and held that the settlements did not exceed the scope of schering’s ‘743 patent.76 on appeal, the third circuit rejected the scope of patent test.77 the court instructed “the district court to apply a quick look rule of reason analysis based on the economic realities of the reverse payment settlement rather than the labels applied by the settling parties.”78 “[a] generic patent challenger who agrees to delay entry into the market [is] prima facie evidence of an unreasonable restraint of trade, which [can] be rebutted by showing that the payment 72 id. at 205. 73 id. at 206. 74 id. at 206-07. however, the ftc’s suit is not part of this appeal. after an administrative law judge dismissed the ftc’s complaint, the ftc issued a final order that the settlements were unreasonable restraints on commerce. id. at 207; in re schering-plough corp., final order, 136 f.t.c. 956, 1052 (2003). subsequently, schering appealed the ftc’s final order to the eleventh circuit which reversed under the scope of patent test. schering-plough corp. v. ftc, 402 f.3d 1056, 1058 (11th cir. 2005). 75 in re k-dur, 686 f.3d at 208. 76 id. 77 id. at 214. 78 id. at 218. 2015 rationale behind hatch-waxman act and patent law 439 (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.”79 2. ftc v. watson pharmaceuticals inc.80 in 2000, the fda approved an nda for solvay pharmaceuticals (“solvay”) for its drug androgel.81 in 2003, under paragraph iv certification, watson pharmaceuticals, inc. (now actavis)82 (“watson”) filed an anda for a generic version of androgel.83 further, after watson filed their anda, paddock laboratories (“paddock”) also filed an anda under paragraph iv certification.84 not filing a separate anda, par pharmaceutical (“par”) joined paddock on the patent litigation in exchange for potential profit from paddock’s generic drug.85 as a result of paragraph iv certification filed by watson and paddock, solvay filed suit for patent infringement within the appropriate forty-five day window.86 litigation ensued until 2006 when all parties settled and entered into the following reverse payment settlement agreements.87 first, solvay’s settlement with watson provided the following: (a) watson would not bring its generic to market until august 31, 2015, sixty-five months before solvay’s patent expired; (b) watson would promote androgel to urologists; and (c) solvay would share with watson an estimated profit of $19-$30 million annually for nine years.88 second, solvay’s settlement with paddock and par 79 id. 80 ftc v. watson pharms. inc., 677 f.3d 1298 (11th cir. 2012), rev’d sub nom. f.t.c. v. actavis, inc., 133 s. ct. 2223 (2013). 81 id. at 1304. 82 press release, actavis, inc., watson announces new name-actavis--for global operations (oct. 31, 2012) (on file with author), available at http://phx.corporate-ir.net/phoenix.zhtml?c=65778&p=irolnewsarticle&id=1752588&highlight=. 83 watson pharms., 677 f.3d at 1304. 84 id. 85 id. 86 id. 87 id. at 1304-05. 88 id. at 1305. 440 indiana health law review vol. 12:1 provided for: (a) paddock/par would not bring its generic to market until august 31, 2015; (b) par would promote androgel to primary care doctors; (c) par was to serve as a backup manufacturer; and (d) paddock/par would receive $10 million per year for six years and $2 million per year for the backup manufacturer deal.89 after reporting the settlement, the ftc filed an antitrust lawsuit against the four companies.90 while solvay, watson, paddock, and par contended the payments of compensation were for services provided by the generic manufacturers, the ftc alleged that the agreements were just to keep generic androgel off the market.91 applying the scope of patent test, the district court dismissed the ftc’s complaint because it did not allege that the settlement exceeded the scope of solvay’s patent.92 on appeal, the eleventh circuit affirmed.93 in doing so, the eleven circuit reaffirmed its holding in valley drug that “reverse payment settlements are immune from antitrust liability if the anticompetitive effects of their settlement fall ‘within the scope of the exclusionary potential of the patent.’”94 3. ftc v. actavis, inc.95 after ftc v. watson pharmaceuticals inc. was decided, the supreme court of the united states granted certiorari due to the circuit split between the third and eleventh circuit. the court rejected the eleventh circuit’s application of the scope of patent test.96 in doing so, the court held that the ftc should have the opportunity to prove its antitrust claim under the rule of reason.97 89 id. 90 id. 91 id. 92 id. at 1306. 93 id. at 1315. 94 id. at 1309 (quoting valley drug co. v. geneva pharms., inc., 344 f.3d 1294, 1311 (11th cir. 2003)). 95 ftc v. actavis, inc., 133 s. ct. 2223 (2013). 96 id. at 2231. 97 id. at 2234. 2015 rationale behind hatch-waxman act and patent law 441 the court set out a list of five considerations for lower courts to look at when analyzing a reverse payment settlement. first, “the specific restraint at issue has the potential for genuine adverse effects on competition.”98 second, “these anticompetitive consequences will at least sometimes prove unjustified.”99 third, “where a reverse payment threatens to work unjustified anticompetitive harm, the patentee likely possesses the power to bring that harm about in practice.”100 fourth, “an antitrust action is likely to prove more feasible administratively than the eleventh circuit believed.”101 fifth, “the fact that a large, unjustified reverse payment risks antitrust liability does not prevent litigating parties from settling their lawsuit.”102 further, the court rejected the ftc’s argument and third circuit’s application of a quick look approach.103 the court reasoned that reverse payment settlements are complex and may not be understood by “an observer with . . . [a] rudimentary understanding of economics”104 because “a reverse payment bringing about anticompetitive effects [(a)] depends upon its size, [(b)] its scale in relation to the payor’s anticipated future litigation costs, [(c)] its independence from other services for which it might represent payment, and [(d)] the lack of any other convincing justification.”105 in dissent, chief justice roberts, along with justices scalia and thomas, argued that the scope of patent analysis should govern.106 the dissent recognized the long-lived principle that a patent is an exception to antitrust law and grants monopolistic powers to the holder.107 moreover, the dissent argued that it has been “long recognized that a patent holder is entitled to license a competitor to sell its product on the condition that the competitor charge a 98 id. 99 id. at 2235-36. 100 id. at 2236. 101 id. 102 id. at 2237. 103 id. 104 id. 105 id. 106 id. at 2238 (roberts, c.j., dissenting). 107 id. 442 indiana health law review vol. 12:1 certain, fixed price” and there is no violation of antitrust law “for a competitor to refrain from challenging a patent.”108 the dissent went as far as saying that the majorities’ approach will ironically “discourage generics from challenging pharmaceutical patents” because of the cost, time, and uncertainty of patent litigation.109 subsequently, the dissent held there can be no violation of antitrust laws when the patent holder is acting within the scope of their patent.110 f. what is the rule of reason? section 1 of the sherman act states: “[e]very contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce among the several states, or with foreign nations, is declared to be illegal.”111 in determining whether there is a restraint on trade in violation of section 1, courts apply the rule of reason.112 what is more, the supreme court has interpreted this statute as only prohibiting unreasonable restraints of trade.113 “under this rule, the factfinder weighs all of the circumstances of a case in deciding whether a restrictive practice should be prohibited as imposing an unreasonable restraint on competition.”114 this inquiry is generally viewed by courts in terms of shifting the burden of proof.115 first, “the plaintiff carries the burden of showing that an agreement or contract has an anticompetitive effect on a given market within a geographic area.”116 second, “[i]f the 108 id. at 2239. 109 id. at 2247. 110 id. at 2239. 111 15 u.s.c. § 1 (2015). 112 leegin creative leather prods., inc. v. psks, inc., 551 u.s. 877, 885 (2007). 113 nat’l collegiate athletic ass’n v. bd. of regents of univ. of okla., 468 u.s. 85, 98 (1984). 114 leegin creative leather products, 551 u.s. at 885 (quoting cont’l t.v., inc. v. gte sylvania inc., 433 u.s. 36, 49 (1977)). 115 william holmes & melissa mangiaracina, antitrsut law handbook §2:10 (2013). 116 agnew v. nat’l collegiate athletic ass’n, 683 f.3d 328, 335 (7th cir. 2012) (citing reifert v. s. cent. wis. mls corp., 450 f.3d 312, 321 2015 rationale behind hatch-waxman act and patent law 443 plaintiff meets his burden, the defendant can show that the restraint in question actually has a procompetitive effect on balance.”117 third, “the plaintiff can dispute [the defendant’s] claim or show that the restraint in question is not reasonably necessary to achieve the procompetitive objective.”118 lastly, some courts recognize that when there are restraints and procompetitive effects, a court must balance the effects.119 however, one author argues that balancing is a myth because “[m]ost cases are resolved based on the weight of the evidence and the presence or absence of evidence of competitive effects or evident and substantial efficiencies.”120 g. congress addresses reverse payment settlements in 2013, senator amy klobuchar introduced the preserve access to affordable generics act (“paaga”).121 the intent of paaga is “[t]o prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.”122 furthermore, paaga includes a strong presumption that a reverse payment settlement is anticompetitive when the generic manufacturer “receives anything of value” or when the generic manufacturer “agrees to limit or forego (7th cir. 2006)). see also major league baseball props., inc. v. salvino, inc. 542 f.3d 290, 317 (2d cir. 2008); law v. nat’l collegiate athletic ass’n, 134 f.3d 1010, 1019 (10th cir. 1998). 117 agnew, 683 f.3d at 335-36. see also major league baseball props., 542 f.3d at 317; law, 134 f.3d at 1019. 118 agnew, 683 f.3d at 336. see also major league baseball props., 542 f.3d at 317; law, 134 f.3d at 1019. 119 stop & shop supermarket co. v. blue cross & blue shield of r.i., 373 f.3d 57, 61 (1st cir. 2004); america ad mgmt., inc. v. gte corp., 92 f.3d 781, 789 (9th cir. 1996). 120 andrew i. gavil, moving beyond caricature and characterization: the modern rule of reason in practice, 85 s. cal. l. rev. 733, 761 (2012). 121 preserve access to affordable generics act, s. 214, 113th cong. (2013). 122 id. 444 indiana health law review vol. 12:1 research, development, manufacturing, marketing, or sales of the [generic] product for any period of time.”123 iii. analysis: the residual effect of actavis and importance of crafting pro-competitive settlements a. impact of using rule of reason analysis the rule of reason appropriately strikes a balance between and supports the policy rationale behind the hatch-waxman act and patent law. first, rule of reason analysis directly supports one of the intentions behind the hatch-waxman act: having more generic drugs available for consumers.124 second, patent law protection will still be available for pioneer manufacturers, thus, supporting patent law and another rationale behind the hatchwaxman act: developing new drugs.125 finally, by applying rule of reason analysis to reverse payment settlements, consumers and manufactures are likely to be affected differently, with the former benefiting and the latter burdening. 1. effect of antitrust laws: how consumers benefit a 2010 analysis by the ftc found that reverse payment settlements cost consumers $3.5 billion annually.126 meanwhile, the goal of antitrust law is to benefit consumers by promoting competition in the marketplace.127 by providing greater competition (supply), more suppliers will be forced to fight over a finite number of consumers which can result in the supplier lowering costs or developing a superior product in order to attract consumers. therefore, by applying antitrust analysis to reverse payment settlements, consumers are likely to benefit from more 123 id. at § 28(a)(2). 124 caraco pharm. labs., ltd. v. forest labs., inc. 527 f.3d 1278, 1282 (fed. cir. 2008). 125 id. 126 pay-for-delay, supra note 9. 127 58 c.j.s monopolies § 7 (2014). 2015 rationale behind hatch-waxman act and patent law 445 drugs being introduced into the market, an effect supported by the hatch-waxman act. first, applying the rule of reason will increase market competition by forcing generic companies to enter the market sooner.128 many, if not all, reverse payment settlements, as part of the agreement, require generic manufactures to delay marketing of its drug.129 as a result of actavis, reverse payment settlement will not be able to focus on delaying a generic drug as consideration for a monetary payment by the pioneer manufacturer. in actavis, the court made it clear that most delays will not be tolerated.130 by not including delays, more generic drugs will enter the market in a quicker time frame. this shows how the rule of reason supports the intention behind the hatch-waxman act to have more generic drugs on the market.131 therefore, more generic drugs will be able to enter the markets sooner, which will result in more competition between drug manufacturers. on the other hand, as chief justice roberts argued in actavis, generic manufacturers may challenge pioneer manufacturer’s patents less often.132 generally, patent litigation is expensive and time consuming. generic manufacturers will need to weigh the costs and benefits of bringing a lawsuit, and there may be times where a generic manufacturer chooses not to bring lawsuit when it would have pre-actavis. moreover, generic manufacturers may 128 angela maas, supreme court punts on pay-for-delay, prompting disagreement over impact, ais health (june 21, 2013), http://aishealth.com/archive/ndbn062113-02. 129 ark. carpenters health and welfare fund v. bayer ag, 604 f.3d 98, 102 (2d cir. 2010) (delay until patent expired); schering-plough corp. v. f.t.c. 402 f.3d 1056, 1060 (11th cir. 2005) (delay until three years before patent expired); valley drug co. v. geneva pharms., inc. 344 f.3d 1294, 1300 (11th cir. 2003) (delay until another generic entered market or patent expired); la. wholesale drug co., inc. v. shire llc, 929 f.supp.2d 256, 258 (s.d.n.y. 2013) (three year delay). 130 ftc v. actavis, inc. 133 s. ct. 2223, 2234 (2013). 131 see id. (citing 148 cong. rec. 14437 (2002) (remarks of sen. hatch) (“it was and is very clear that the [hatch–waxman act] was not designed to allow deals between brand and generic companies to delay competition.”)). 132 id. at 2247 (roberts, c.j., dissenting). 446 indiana health law review vol. 12:1 not want to spend money and invest the necessary time when there is a level of uncertainty surrounding the validity of a patent. as a result, actavis may not effectuate the intent of hatch-waxman to increase the amount of generic drugs in a market. second, consumers will receive lower-cost drugs marketed in a more timely fashion.133 part of the growing cost of healthcare involves the rising cost of prescription drugs. from 2005 until 2009, the cost of prescription drugs has risen from $201.7 billion to $249.9 billion per year.134 the fda has reported, on average, generic drugs cost 8085% less than brand name drugs.135 it is estimated that generic drugs saved consumers $700 billion from 1999 until 2008.136 further, some estimations state that reverse payment settlements cost consumers approximately $3.5 billion per year.137 under actavis, generic manufacturers will be able to introduce more generic drugs into the market in a more consumer friendly time. generic drugs will be marketed sooner as a result of actavis because settlement agreements between pioneer and generic manufacturers will likely not include delays or will include delays that are substantially less than pre-actavis settlements. more generic drugs in the market will translate into more generic drugs being available for consumers at a lower cost, a result of basic economic principles of supply and demand. consequently, the rule of reason furthers the intent of the hatch-waxman act to lower the cost of drugs for consumer. 133 aaron kesselheim & nathan shiu, ftc v. actavis: the supreme court issues a reversal on reverse payments, health affairs blog (june 21, 2013), http://healthaffairs.org/blog/2013/06/21/ftc-v-actavisthe-supreme-court-issues-a-reversal-on-reverse-payments/. 134 2012 census, supra note 8. 135 facts about generic drugs, u.s. food & drug administration, http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedici nesafely/understandinggenericdrugs/ucm167991.htm (last visited sept. 17, 2014). 136 scott hemphill & bhaven n. sampat, when do generics challenge drug patents?, 8 j. empirical legal stud. 613, 614 (2011). 137 ftc v. watson pharms., inc. 677 f.3d 1298, 1302 (11th cir. 2012). http://dx.doi.org/10.1111/j.1740-1461.2011.01235.x 2015 rationale behind hatch-waxman act and patent law 447 alternatively, it is a possibility that pioneer manufacturers may pass on any lost profits to consumers. pioneer manufacturers whose patent term is undercut are at risk of losing a substantial amount of revenue. in order to counter this, pioneer manufacturers may charge a higher price during its initial selling period (when the patent still protects its ability to charge monopolistic prices). regardless, consumers may benefit because the costs passed on may not rise to the billions of extra dollars consumers spend on branded drugs due to monopolistic prices.138 third, consumers may improve their health outcomes as a result of pioneer manufacturers developing more new active ingredient drugs. as a result of actavis, pioneer drug manufacturers may allocate more resources into developing new active ingredients as opposed to updating formulas of old products.139 as one empirical study, analyzing what type of drug patents get challenged most frequently under the paragraph iv route, suggests, generic companies more often challenge pioneer drugs using a new formulation as compared to pioneer drugs containing a new active ingredient.140 by focusing on new active ingredients, there is a lower risk of patent litigation because a generic company is less likely to challenge the patent’s validity. while new active ingredient drugs may be less likely to be challenged, it would be unwise to expect a huge shift in development of new active ingredient drugs as they are 138 see pay-for-delay, supra note 9 (explaining that a brand name drug cost $300/month while the generic equivalent costs $30/month). 139 kesselheim & shiu, supra note 133. 140 hemphill & sampat, supra note 136, at 643. analyzing paragraph iv challenges under the hatch-waxman act, as a sample size, the researchers looked at drugs that were first eligible for challenge in 2000-2008. id. in their findings, they found a strong association between patent portfolios and generic challenges. id. specifically, non-active ingredient patents are challenged more frequently. id. further, patent portfolios with low-quality patents, extra nominal patents and late filed patents are much more likely to draw a paragraph iv challenge. id. the authors rejected the hypothesis that the composition of a drug’s patent portfolio is not correlated to paragraph iv challenges. id. subsequently, as opposed to the conventional wisdom that challenges are only about sales, patent portfolio characteristics may have a significant effect. id. 448 indiana health law review vol. 12:1 extremely costly and still subject to patent challenges. with all that is considered, pioneer drug manufacturers who input more resources into new active ingredients will likely have an increased chance, albeit a small increase, of avoiding patent litigation while also providing socially valuable research and development.141 accordingly, the policy interests of the hatch-waxman act and patent law are supported as new research will be completed, resulting in new drug development. however, developing new active ingredient drugs may not be a realistic business model for all pioneer manufactures. new drug development takes on average ten to fifteen years and costs, on average, over $1.3 billion.142 also, not all new drugs are approved by the fda nor are all expenditures for research and development recouped.143 this disincentive for developing new drugs can be alleviated, in part, through patents. “strong protection of intellectual property rights, and the accompanying rewards, provides an incentive for pharmaceutical companies to make such a large, high-risk investment.”144 one solution to the disincentive created by cost may be for congress to provide greater incentives for developing new active ingredient drugs by providing them with a longer patent term or make it harder for generic manufacturers to challenge patents based on new active ingredients. 141 see id. at 644 (suggesting that paragraph iv challenges target drugs with weak late-expiring patents and because weak late-expiring patents are assumed to be less related to socially valuable research and development, challenges may be an important means to curtail patents that have high social costs which stem from sustaining high prices for consumers). 142 bret dickey et al., an economic assessment of patent settlements in the pharmaceutical industry, 19 annals health l. 367, 369 (2010). 143 id. 144 id. 2015 rationale behind hatch-waxman act and patent law 449 2. effect of antitrust laws: different affect on drug manufacturers since the advent of reverse payment settlements, courts analyzing these settlements under the scope of patent test provided manufacturers with “a safety net.” the scope of patent test provided manufacturers with an “almost unrebuttable presumption of patent validity.”145 any act of congress creating a presumption against reverse payment settlements146 will create unwarranted burdens for drug manufacturers to a much stronger degree than the rule of reason. in retreating from a presumption of patent validity under the scope of patent test, drug manufacturers, under the rule of reason analysis, will be burdened, but in a manageable way. subsequently, burdens placed on drug manufacturers will adversely affect the intentions behind the hatch-waxman act and patent law to stimulate innovative research and development. first, due to ambiguity created by actavis, parties in a patent infringement suit will be less likely to settle and more likely to litigate. further, any presumption against reverse payment settlements enacted by congress will further deter manufacturers from considering settlement. fewer settlements equate to patent infringement suits becoming more expensive for both pioneer and generic manufacturers. increases in litigation costs can arise out of “(1) direct litigation costs, (2) indirect costs, such as requiring the attention of company executives, distracting them from the operation of the business, and (3) costs due to the uncertainty of litigation outcomes.”147 also, applying the rule of reason analysis will lead to more expansive discovery148 which will lengthen lawsuit duration and 145 in re k-dur antitrust litig., 686 f.3d 197, 214 (3d cir. 2012). 146 see preserve access to affordable generics act, s. 214, 113th cong. § 28(a)(2) (2013) (establishing a presumption that reverse payment settlements are anticompetitive). 147 dickey, supra note 142, at 375. 148 cal. dental ass’n v. ftc, 526 u.s. 756, 759 (1999) (explaining how rule of reason analysis “demands a more thorough enquiry” than a “quick-look” analysis). 450 indiana health law review vol. 12:1 thereby increase the cost of litigation.149 although, while the court stated that it was not establishing a quick-look analysis,150 the court’s emphasis on the “size of payment”151 implies there is an element of quick-look analysis which the court has subtly approved. as a result, it is unlikely that all litigation will be lengthy. as the court suggests, it is not always necessary to litigate patent validity in order to determine if the settlement is anticompetitive.152 increased cost of litigation may also result in generic manufacturers challenging fewer patents. generic manufacturers may be reluctant to challenge a patent as generic manufacturers have historically lost more often than not when patent litigation proceeds to a judgment.153 as chief justice roberts argued in dissent, the majority’s opinion may discourage generic manufacturers from certifying under paragraph iv as “[p]atent litigation is costly, time consuming, and uncertain.”154 as a result, it may only be economically feasible for generic manufacturers to challenge certain patents and not challenge other patents it would have pre-actavis. therefore, generic manufactures may choose to only target weak patents, ones that have a high likelihood of invalidity.155 149 see ariz. v. maricopa cnty. med. soc’y, 457 u.s. 332, 343 (1982)( “the elaborate inquiry into the reasonableness of a challenged business practice entails significant costs.”); kenneth r. o’rourke et al., ftc v. actavis: reconciling conflicts in rule of reason, law 360 (july 2, 2013, 5:55 pm), http://www.law360.com/articles/453428/ftc-v-actavisreconciling-conflicts-in-rule-of-reason. 150 ftc v. actavis, inc., 133 s. ct. 2223, 2237 (2013). 151 id. at 2236-37 (suggesting that a large, unexplainable reverse payment implies a patent is weak and precludes a court from “conduct[ing] a detailed exploration [into] the validity of the patent”). 152 id. at 2236. 153 bret dickey & jonathan orszag, the benefits of patent settlements: new survey evidence on factors affecting generic drug investment, generic pharm. ass’n (july 23, 2013), http://www.gphaonline.org/media/cms/dickey_orszag_benefits_of_pate nt_settlements_2012-07-21_final.pdf (finding when patent litigation goes to a judgment generic manufacturers loose two out of three times). 154 actavis, 133 s. ct. at 2247 (roberts, c.j., dissenting). 155 see hemphill & sampat, supra note 136, at 635-36 (finding a correlation between patent strength and likelihood of a challenge to validity). 2015 rationale behind hatch-waxman act and patent law 451 second, pioneer manufacturers will lose revenue and profits by not being able to delay generic manufacturers from entering the market. this will result from more consumers purchasing the less expensive generic drug. for example, solvay pharmaceuticals, the pioneer manufacturer in actavis, estimated the generic version of androgel could decrease the sales of branded androgel by 90% and cut solvay’s profits by $125 million per year.156 additionally, in 2013, pfizer reported that the loss of patent protection in november 2011 on lipitor and other patents expiring around that time resulted in a reduction in net income by “$3 billion to $4 billion a year.”157 contrary to the hatch-waxman act and patent law, which attempt to incentivize pioneer manufacturers to develop new drugs, losing such a large amount of revenue will disincentivize pioneer manufacturers from developing new drugs in the future. on the other hand, pioneer manufacturers may not suffer any substantial loss of revenue. generic manufacturers take into account many factors, like most other businesses, before choosing to invest in a product. one report which polled generic manufacturers, and had it rank its most important factors affecting investment decisions, found that ability to settle litigation was more important than items such as number of patents or market size.158 this finding shows that in some circumstances, a generic manufacturer may be influenced by a decreased likelihood of ability to settle. as a result, generic manufacturers in the future may not invest in as many products and subsequently, file fewer andas under the paragraph iv route. third, reverse payment settlements may be uncertain and dangerous to enter into, and as a result manufacturers 156 ftc v. watson pharms., inc. 677 f.3d 1298, 1305 (11th cir. 2012). 157 pressure from generic drugs shrinks profit at pfizer, n.y. times (oct. 29, 2013), http://www.nytimes.com/2013/10/30/business/ pressurefrom-generic-drugs-shrinks-profit-at-pfizer.html?_r=0. 158 dickey & orszag, supra note 153 (finding that ability to settle litigation had an average importance of 2.93/5). 452 indiana health law review vol. 12:1 may risk millions of dollars on the outcome of litigation.159 this may be seen as a large burden placed on manufacturers because “[m]ost patent litigation is resolved through a settlement between the parties.”160 moreover, this uncertainty and influence on reverse payment settlements will vary as some companies may be more risk averse than others. the supreme court in actavis chose not to establish a bright line rule and instead laid out five general considerations for lower courts.161 in doing so, until precedent is established, there will be uncertainty on whether or not a reverse payment settlement is anticompetitive. even after the advent of precedent, there will still be uncertainty between the different circuits. this uncertainty will lead manufacturers to avoid settlements and litigate to judgment. in doing so, funds that could be spent on research and development will be funneled into costly litigation. for instance, in the case of a pioneer manufacturer, it will be risking billions of dollars on a district court’s interpretation of actavis. while the rule of reason will place small burdens on manufacturers, any presumption of anticompetitiveness established by congress will cause more severe burdens on manufacturers. b. complying with the actavis framework: crafting procompetitive reverse payment settlements in actavis, the court held that “the likelihood of a reverse payment bringing about anticompetitive effects [(a)] depends upon its size, [(b)] its scale in relation to the payor’s anticipated future litigation costs, [(c)] its independence from other services for which it might represent payment, 159 jennifer driscoll-chippendale & bradley graveline, ftc v. actavis: what does it mean for reverse-payment settlement?, jdsupra business advisor (june 24, 2013), http://www.jdsupra.com/legalnews/ftc-v-actavis-what-does-it-mean-forre-68321/. 160 dickey, supra note 142, at 373-74 (citing carl shapiro, antitrust limits to patent settlements, 43 rand j. of econ., 391, 392 (2003)). 161 ftc v. actavis, inc., 133 s. ct. 2223, 2234-37 (2013). http://dx.doi.org/10.2139/ssrn.273552 2015 rationale behind hatch-waxman act and patent law 453 and [(d)] the lack of any other convincing justification.”162 although, “there is always something of a sliding scale in appraising reasonableness . . . .”163 actavis correctly held that the rule of reason is appropriate for analyzing reverse payment settlements. allowing pioneer manufacturers to create procompetitive reverse payment settlements furthers the intent behind the hatch-waxman act by benefiting both consumers and drug manufacturers. additionally, the motivation created by patent law to develop new drugs will not be at risk because settlements protect a manufacturer’s rights under its patent. conversely, any act by congress to create a presumption that reverse payment settlements are anticompetitive164 will adversely affect the rationale behind the hatch-waxman act and patent law. the following is an analysis of relevant antitrust factors, the court’s considerations in actavis, and other relevant considerations which support the rationale behind the hatch-waxman act and patent law. 1. what type of payments implicate the actavis analysis? when does actavis apply? does it apply to only monetary payments? the supreme court has stated “the rule of reason requires the factfinder to decide whether under all the circumstances of the case the restrictive practice imposes an unreasonable restraint on competition.”165 a straightforward reading of this statement would lead one to believe actavis applies in all cases where a reverse payment settlement creates unreasonable restraints on trade. this is supported by antitrust common law which generally focuses on unreasonable restraints caused by the restrict practice.166 162 id. at 2237. 163 id. (quoting cal. dental ass’n v. ftc, 526 u.s. 756, 780 (1999)). 164 preserve access to affordable generics act, s. 214, 113th cong. (2013). 165 ariz. v. maricopa cnty. med. soc’y, 457 u.s. 332, 343 (1982). 166 see cont’l t.v., inc. v. gte sylvania inc., 433 u.s. 36, 49 (1977); bd. of trade of city of chi. v. united states, 246 u.s. 231, 238 (1918); 454 indiana health law review vol. 12:1 although, the language of actavis does not speak broadly, it speaks narrowly, in reference to monetary payments. as judge walls stated: “[b]oth the majority and dissenting opinions reek with the discussion of payment of money.”167 throughout the opinion, the court continuously discusses reverse payments in terms of a monetary payment, as opposed to a reverse payment for any financial benefit.168 therefore, this language implies that actavis only applies to those reverse payment settlements involving monetary payments. 2. market power according to the supreme court, the market power possessed by the pioneer manufacturer may indicate anticompetitive harm.169 under rule of reason analysis, “a plaintiff must show that the defendant has market power— that is, the ability to raise prices significantly without going out of business—without which the defendant could not cause anticompetitive effects on market pricing.”170 also, a plaintiff may “establish anticompetitive effect indirectly by proving the defendant possessed the requisite market power within a defined market.”171 congress’ approach, applying a presumption of anticompetitive harm,172 is erroneous as it major league baseball props., inc. v. salvino, inc. 542 f.3d 290, 316 (2d cir. 2008). 167 in re lamictal direct purchaser antitrust litig., 18 f.supp.3d 560, 567 (d. n.j. 2014). 168 ftc v. actavis, inc., 133 s. ct. 2223, 2227 (2013) (“company a, the patentee, to pay b many millions of dollars.”) (emphasis added); id. at 2233 (“in reverse payment settlements . . . a party with no claim for damages . . . walks away with money.”) (emphasis added); id. at 2235 (“[p]atentees sometimes pay a generic challenger a sum even larger than what the generic would gain in profits.”). 169 id. at 2236. 170 agnew v. nat’l collegiate athletic ass’n, 683 f.3d 328, 335 (7th cir. 2012) (citing valley liquors, inc. v. renfield importers, ltd., 822 f.2d 656, 666 (7th cir. 1987)). 171 law v. nat’l collegiate athletic ass’n, 134 f.3d 1010, 1019 (10th cir. 1998). 172 preserve access to affordable generics act, s. 214, 113th cong. § 28(a)(2) (2013). 2015 rationale behind hatch-waxman act and patent law 455 presumes the pioneer manufacturer has market power when that may not be accurate in one-hundred percent of cases. in actavis, the court was concerned with a pioneer manufacturer using monopolistic power to receive “higherthan-competitive profits.”173 a pioneer manufacturer who is receiving monopolistic profits may use this power to leverage and finance a deal to provide the generic manufacturer with an otherwise unexplainably large settlement payment. due to the monopolistic power of said manufacturer, a pioneer manufacturer could pay the generic manufacturer an exorbitant amount and recoup those losses in the form of higher prices or by keeping the product at the monopolistic price for more years, which in turn harms consumers. moreover, this “market power” factor will be product specific. market power will be less relevant in markets where competition is greater and other alternatives to the pioneer manufacturer’s drug exist. subsequently, in a market with minimal competition, a large reverse payment may look more like an attempt by the pioneer manufacture to keep their monopoly and continue to charge a monopolistic price to consumers. 3. relevant market under the rule of reason, a plaintiff’s initial burden is to establish the anticompetitive effect on a given market.174 “antitrust claims often rise or fall on the definition of the relevant market.”175 the supreme court has held that the relevant market consists of “commodities reasonably 173 actavis, 133 s. ct. at 2236; see also in re nexium (esomeprazole) antitrust litig., 968 f. supp. 2d 367, 389 (d. mass. 2013) (noting that astrazeneca exercised market power by using its monopolistic position to “charge supracompetitive prices for brand nexium”). 174 agnew, 683 f.3d at 335 (citing reifert v. s. cent. wis. mls corp., 450 f.3d 312, 321 (7th cir. 2006)); major league baseball props., inc. v. salvino, inc. 542 f.3d 290, 317 (2d cir. 2008); law, 134 f.3d at 1019. 175 se. mo. hosp. v. c.r. bard, inc., 642 f.3d 608, 613 (8th cir. 2011) (quoting bathke v. casey’s gen. stores, inc., 64 f.3d 340, 345 (8th cir. 2009)). 456 indiana health law review vol. 12:1 interchangeable by consumers for the same purposes . . . .”176 for instance, the district court in in re nexium said the “relevant market [was] comprised of brand and generic nexium . . . .”177 notwithstanding the fact that generics are intended to be substitutes, an argument could be made that pioneer and generic drugs are in different markets because a consumer, based on personal preference, would not substitute one product for another despite a decrease in price by one of the drugs.178 for example, if an inactive ingredient179 in the generic drug adversely affects consumers to the point that consumers will only purchase the branded drug. however, this would likely require a drug being used by a small number of consumers who all, or at least a large majority, are adversely affected by the same inactive ingredient in the generic drug. 4. redeeming virtues in the context of reverse payment settlements, even the ftc has admitted “offsetting or redeeming virtues are sometimes present.”180 a defendant under the rule of reason can rebut the plaintiff’s initial burden by showing procompetitive effects from the restraint.181 payments may be justified if they are intended to allow the generic manufacturer to develop other (additional) generic drugs for the consumer’s benefit.182 moreover, any redeeming virtue 176 united states v. e.i. du pont de nemours & co., 351 u.s. 377, 395 (1956). 177 in re nexium, 968 f. supp. 2d at 389. 178 see e.i. du pont de nemours & co., 351 u.s. at 400. 179 generic drugs: answers to common questions, webmd, http://www.webmd.com/healthy-aging/guide/generic-drugs-answers-tocommon-questions (last visited aug. 27, 2014) (discussing how generic drugs can have different inactive ingredients). 180 ftc v. actavis, inc., 133 s. ct. 2223, 2236 (2013). 181 agnew v. nat’l collegiate athletic ass’n, 683 f.3d 328, 335-36 (7th cir. 2012); major league baseball props., inc. v. salvino, inc. 542 f.3d 290, 317 (2d cir. 2008); law v. nat’l collegiate athletic ass’n, 134 f.3d 1010, 1019 (10th cir. 1998). 182 jeff overley, big pharma’s legal bill to take hit from pay-fordelay ruling, law 360 (june 17, 2013, 8:08 pm), 2015 rationale behind hatch-waxman act and patent law 457 or benefit provided must be more compelling than the policy favoring settlements;183 the court has held that this factor alone is not sufficient to overcome anticompetitive consequences.184 for example, based on the example in the introduction, xyz agrees not to enter into the market for abc’s drug 23.185 as consideration, abc provides some form of compensation to xyz which in turn lets xyz introduce one or more other generic drugs into the market. while the consumers may be hurt by the anticompetitive effect of not allowing xyz to sell generic drug 70, the consumers may benefit overall due to other generic drugs xyz will introduce into the market.186 this hypothetical situation would require the drug manufacturers to show there are procompetitive effects caused by not allowing one generic drug to enter the market. as a result, the consumer benefit would outweigh harm through development and production of other generic drugs. moreover, it would be necessary for the drug manufacturers to show the restraint caused by the reverse payment settlement is reasonably necessary to achieve the procompetitive effect.187 subsequently, in the antitrust http://www.law360.com/articles/450706/big-pharma-s-legal-bill-to-takehit-from-pay-for-delay-ruling. 183 in re nexium (esomeprazole) antitrust litig., 968 f. supp. 2d 367, 410 (d. mass. 2013) (holding that settlement of patent disputes does not overcome anticompetitive consequences). 184 actavis, 133 s. ct. at 2234 (discussing how the eleventh circuit’s justification based on policy favoring settlements is not determinative). 185 see supra section i. 186 contra in re nexium, 968 f. supp. 2d at 391 (finding that anticompetitive consequences resulted from pioneer manufacture forgiving contingent liabilities owed to them by generic manufacturers, for infringement of unrelated patents, in exchange for generic manufacturers agreeing that the pioneer manufacturer’s patents were valid, being infringed by them, and they would delay the sale of generic nexium). 187 see agnew v. nat’l collegiate athletic ass’n, 683 f.3d 328, 336 (7th cir. 2012) (plaintiff can rebut defendant assertion of a procompetitive effect by showing it is not reasonably necessary to achieve the objective); see also major league baseball props., inc. v. 458 indiana health law review vol. 12:1 context, creating an overall benefit for consumers may be seen as a redeeming virtue. additionally, a cash payment from a pioneer manufacture to a generic manufacture may be procompetitive depending on the economic situation of the generic manufacturer. as the third circuit suggested, “a modest cash payment that enables a cash-starved generic manufacturer to avoid bankruptcy and begin marketing a generic drug might have an overall effect of increasing the amount of competition in the market.”188 this example would provide a redeeming virtue that would not otherwise occur absent the reverse payment settlement. 5. size of monetary payments of main concern for the court was a pioneer manufacturer offering a large sum of money to a generic manufacturer in order to keep its product out of the market so the pioneer manufacture can maximize revenue at the expense of consumers.189 for example, a large payment was clearly made when a pioneer manufacturer agreed to pay a generic manufacturer over $1,000,000,000 in exchange for the generic manufacturer agreeing that the pioneer manufacturer’s patents were valid, being infringed by the generic manufacturer, and having the generic manufacturer delay entry.190 as one commentator puts it, “the larger the reverse payment, the riskier the settlement from an antitrust perspective.”191 keeping the monetary payment in the settlement consistent with some of the justifications below will go a long way in showing that the reverse payment settlement does not present anticompetitive harm salvino, inc. 542 f.3d 290, 317 (2d cir. 2008); law v. nat’l collegiate athletic ass’n, 134 f.3d 1010, 1019 (10th cir. 1998). 188 in re k-dur antitrust litig., 686 f. 3d 197, 218 (3d cir. 2012) 189 actavis, 133 s. ct. at 2234. 190 in re nexium, 968 f. supp. 2d at 381-82. 191 what does ftc v. actavis inc. mean for hatch-waxman litigation?, crowell moring (june 21, 2013), http://www.crowell.com/newsevents/alertsnewsletters/all/what-doesftc-v-actavis-inc-mean-for-hatch-waxman-litigation#.um6zafmsim5 [hereinafter crowell moring article]. 2015 rationale behind hatch-waxman act and patent law 459 and supports the rationale behind the hatch-waxman act and patent law.192 one clear justification for reverse payments given by the court is anticipated future litigation costs saved as a result of the settlement.193 this indicates that in a patent infringement suit, pioneer and generic manufacturers should attempt to settle as early as possible. settling early will ensure a larger cost saved and subsequently, a larger reverse payment will be justified. also, it may be argued that indirect costs and uncertainty of the litigation’s outcome may increase future litigation costs. lastly, the complexity of the issue and the number of parties involved will also increase future litigation costs. additionally, the court was concerned with payment sizes which seek to “pay a generic challenger a sum even larger than what the generic would gain in profits.”194 economic projections showing a generic manufacturer earning more revenue by entering the market, as opposed to a settlement, will be persuasive. when the settlement is greater than the generic manufacturer’s expected revenue, it suggests the pioneer and generic manufacturer have an ulterior motive to settle. for example, a pioneer and generic manufacturer may earn more revenue by teaming up and charging monopolistic prices to consumers instead of competing against each other. conversely, a reverse payment settlement not seeking to solely protect the pioneer manufacturer’s monopoly will be viewed as pro-competitive. payments may be further justified if the generic manufacturer provides a service to the pioneer manufacturer.195 such services may include distribution,196 192 in re lamictal direct purchaser antitrust litig., 18 f.supp.3d 560, 570 (d. n.j. 2014) (finding that the value to the generic manufacturer “likely exceed[ed] what the parties would have spent litigating the patent dispute, the consideration which the parties exchanged in the settlement is reasonably related to the removal of the uncertainty created by the dispute”). 193 actavis, 133 s. ct. at 2236. 194 id. at 2235 (citing c. scott hemphill, paying for delay: pharmaceutical patent settlements as a regulatory design problem, 81 n.y. u. l. rev. 1553, 1581 (2006)). 195 id. at 2236. 460 indiana health law review vol. 12:1 marketing,197 consulting, administration, research, quality control, licensing198 and any other business arrangement which is reasonable. for example, in actavis, actavis, paddock, and par provided consideration to solvay by agreeing to promote solvay’s androgel to physicians.199 also, based on the court’s concerns with overpayment, it will be important to determine the fair market value of any services that are provided. further, a reverse payment which is more than the expected loss to the pioneer manufacturer, if they lose the litigation and the generic manufacturer enters the market, implies anticompetitiveness and “pay-for-delay.” this type of payment suggests the pioneer manufacturer’s motive is to keep the generic manufacturer out of the market. for example, using the example from the introduction, if abc is expected to lose $5 million in revenue when xyz enters the market, but enters into a reverse payment for $6 million, abc’s likely motivation is to be able to continue to exert its monopolistic power. on the contrary, a payment which is less than the expected loss to the pioneer manufacturer suggests its motive is not to keep the generic manufacturer out of the market. one way of determining the expected cost to the pioneer manufacturer when losing the patent litigation would be to take the potential lost profits from the generic manufacturer entering the market, mitigated by the litigation odds, and add in any costs saved by settling.200 assume the following: 196 id. 197 id. 198 client memorandum from davis polk & wardwell llp (june 18, 2013) (on file with author), available at http://www.davispolk.com/ download.php?file=sites/default/files/files/publication/3c1830cd-3c9241fc-beff-d7b544d7d7d5/preview/publicationattachment/c59b096e-696f4951-abde-d8c44acadeb6/06.18.13.ftcv.actavis.pdf. 199 actavis, 133 s. ct. at 2229. 200 peter todaro et al., applying the supreme court’s decision in actavis, king & spalding (july 24, 2013), http://www.kslaw.com/ imageserver/kspublic/library/publication/ca072413.pdf. 2015 rationale behind hatch-waxman act and patent law 461 (1) the [pioneer manufacturer’s] future prepatent expiration revenues had a net present value of $1 billion; (2) the [pioneer manufacturer] would lose 90% of its sales upon generic entry; and (3) the [pioneer manufacturer’s] probability of litigation success was 60% making its chance of losing 40%: then the value of a settlement to the [pioneer manufacturer] would be $360 million ($1billion × 90% × 40%).201 additionally, litigation costs or value of services provided by the generic manufacturer would be in addition to the settlement value of $360 million. lastly, “value to the generic [manufacturer] would be determined by the value of consideration received.”202 computing expected costs in this or a similar manner will assist in showing that a reverse payment settlement is not anticompetitive. 6. time frame for generic entry the time frame for the generic manufacturer to enter the market is extremely relevant.203 by restricting the generic manufacturer from entering the market, it can be seen as a restraint on output which has generally been seen as anticompetitive.204 moreover, significantly delaying generic entry may provide ammunition to the ftc to satisfy its initial burden under rule of reason analysis. as the court stated in actavis, “permitting the patent challenger to enter the market before the patent expires would also bring about competition . . . to the consumer’s benefit.”205 allowing generic manufacturers to enter the market before the pioneer manufacturer’s patent expires is likely to be seen as 201 id. 202 id. 203 see in re lamictal direct purchaser antitrust litig., 18 f.supp.3d 560, 570 (d. n.j. 2014) (noting that the generic manufacturer “was allowed six months of early entry”). 204 see nat’l collegiate athletic ass’n v. bd. of regents of univ. of okla., 468 u.s. 85, 104 (1984). 205 ftc v. actavis, inc., 133 s. ct. 2223, 2234 (2013). 462 indiana health law review vol. 12:1 procompetitive and is directly supported by the hatchwaxman act because consumers will receive drugs sooner than they would without the settlement. similarly, reaching a settlement not involving a monetary payment and only allowing the generic manufacturer to enter the market before expiration of the pioneer manufacturer’s patent would most likely be procompetitive.206 therefore, allowing generic drugs to enter the market sometime before patent expiration is procompetitive. 7. strength of patent pharmaceutical drugs are patentable inventions under patent law.207 while the court in actavis held that district courts are not necessarily required to litigate the patent’s validity before ruling on the reverse payment settlement,208 the strength of a patent will still be factored into a court’s analysis and may indicate anticompetitive harm.209 by factoring in the strength of a patent, actavis supports the hatch-waxman act and the protections afforded through patent law. generally speaking, a strong patent refers to one “likely to be found valid and infringed.”210 evidence presented in support of a stronger patent is more likely to indicate the reverse payment settlement is for some other justifiable reason or service, as opposed to the payment being used to keep the generic manufacturer out of the market. on the other hand, a weaker patent may indicate the pioneer manufacturer is using the reverse payment in order to avoid 206 id. at 2237. 207 patentable inventions are defined as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement.” 35 u.s.c. § 101 (2015). recently, the supreme court has addressed the limitations of § 101 and held that items naturally occurring in nature are not patent eligible. ass’n for molecular pathology v. myriad genetics, inc., 133 s. ct. 2107, 2111 (2013). furthermore, to be patentable, an invention must be novel, 35 u.s.c. § 102 (2015), and not obvious in the light of prior art, id. § 103. 208 actavis, 133 s. ct. at 2237. 209 overley, supra note 182. 210 dickey & orszag, supra note 153, at 8. 2015 rationale behind hatch-waxman act and patent law 463 litigation regarding validity. subsequently, a settlement “intended to maintain supracompetitive prices and serve as a ‘workable surrogate for a patent’s weakness’”211 indicates anti-competitive harm. 8. venue while venue was extremely important before actavis due to stare decisis,212 venue will still be an important factor to consider in the aftermath of actavis. venue determines which judicial district a civil action may be brought in.213 in actavis, the court left it to the lower courts to structure the rule of reason for reverse payment settlement cases.214 for example, the eleventh circuit may interpret reverse payments under the rule of reason analysis in favor of pharmaceutical manufacturers, as it did before actavis. with no bright-line rules, some circuits will be more or less restrictive as to what constitutes anticompetitive harm. also, most pharmaceutical companies operate on a national or international level. so, common law consistency will be an important factor for pharmaceutical companies in constructing reverse payment settlements. moreover, common law consistency is important in deciding where to appeal ftc final orders since the appellant can choose the circuit of its choice. finally, one circuit may quickly develop 211 see in re lamictal direct purchaser antitrust litig., 18 f.supp.3d 560, 570 (d. n.j. 2014) (emphasis added). 212 compare valley drug co. v. geneva pharms., inc., 344 f.3d 1294 (11th cir. 2003) with in re k-dur antitrust litig., 686 f. 3d 197 (3d cir. 2012). 213 28 u.s.c. § 1391(b)(1)-(3) (2015) (establishing venue in any judicial district where (1) “any defendant resides, if all defendants are residents of the state in which the district is located”; (2) “a substantial part of the events of omissions giving rise to the claim occurred, or a substantial part of property that is the subject of the action is situated”; or (3) “if there is no district in which an action may otherwise be brought as provided in this section, any judicial district in which any defendant is subject to the court's personal jurisdiction with respect to such action”). 214 f.t.c. v. actavis, inc., 133 s. ct. 2223, 2238 (2013). 464 indiana health law review vol. 12:1 a robust common law which will be favored among pharmaceutical manufacturers.215 9. ability to explain all portions of the reverse payment settlement need to be explainable.216 the court in actavis emphasized that unjustified payments carry the risk of anticompetitive effects.217 being able to explain why such payment was made will go a long way to rebutting a claim that the payment is anticompetitive. as one suggestion states, “parties should from the outset have a contemporaneous documented explanation for every dollar of each settlement.”218 iv. policy recommendation: how reverse payment settlements support the intent of patent law and the hatch-waxman act while congress cannot “overrule” a united states supreme court decision,219 congress can pass new laws to effectively overturn a united states supreme court decision.220 presently, some critics argue that congress 215 this may be comparable to the robust common law dealing with corporations in delaware, which has led many corporations to file their articles of incorporation in the state. see generally lewis s. black, jr., why corporations choose delaware (2007), available at http://corp.delaware.gov/whycorporations_web.pdf. 216 see actavis, 133 s. ct. at 2237 (stating that a payment which is unexplainable or unjustifiable can indicate anticompetitive harm). 217 id. 218 crowell moring article, supra note 191. 219 u.s. const. art iii, § 1 (“the judicial power of the united states, shall be vested in one supreme court.”); marbury v. madison, 5 u.s. 137, 177 (1803) (“it is emphatically the province and duty of the judicial department to say what the law is.”). 220 see holmes grp., inc. v. vornado air circulation sys., inc., 535 u.s. 826 (2002), superseded by statute, 28 u.s.c. § 1454(a) (2015); city of mobile, ala. v. bolden, 446 u.s. 55 (1980), superseded by statute, voting rights act of 1965, § 2, pub. l. no. 89-110, 79 stat. 437 (amended 1982), as recognized in bartlett v. strickland, 556 u.s. 1, 10 (2009). 2015 rationale behind hatch-waxman act and patent law 465 should outright ban reverse payment settlements.221 more importantly, in 2013, senator amy klobuchar introduced paaga.222 while the present state of paaga does not create a per se ban on reverse payment settlements, paaga has an anti-reverse payment settlement “taste” and is comparable to the “quick look” analysis previously used by the third circuit.223 the court implicitly rejected the presumption of anticompetitive harm in paaga by explicitly rejecting the quick-look analysis.224 subsequently, this presumption of anticompetitive harm under paaga is contrary to actavis’ holding. congress should not ban reverse payment settlements or invoke analysis requiring a standard more stringent than actavis. instead, congress should endorse the actavis framework for analyzing reverse payment settlements.225 actavis provides a middle ground which supports both the intent behind patent law and rationale of the hatchwaxman act. under actavis, motivation for pioneer manufacturers to innovate coexists with the elimination of frivolous patents and allowing generic drugs to reach the market. to begin with, patent law was designed to “stimulate the efforts of genius” to develop progress in science.226 while patent law was not designed to create “private fortunes for the owners of patents,”227 it is undeniable that most people, 221 ford, supra note 17; see generally pay-for-delay, supra note 9. 222 preserve access to affordable generics act, s. 214, 113th cong. (2013). 223 in re k-dur antitrust litig., 686 f.3d 197, 218 (3d cir. 2012) (holding reverse payment settlements as “prima facie evidence of an unreasonable restraint of trade”). 224 ftc v. actavis, inc., 133 s. ct. 2223, 2237 (2013). 225 see testimony of jonathan m. orszag before the senate judiciary subcomm. on antitrust, competition policy, and consumer rights, 113th cong. 9 (2013) [hereinafter orszag testimony] (statement of jonathan m. orszag, senior managing director, compass lexecon) (stating that congressional action making reverse payment settlements per se illegal or per se immune to challenges would be counterproductive). 226 motion picture patents co. v. universal film mfg. co., 243 u.s. 502, 511 (1917). 227 id. 466 indiana health law review vol. 12:1 especially corporations which work to maximize shareholder profits, are motivated by economic incentives. this incentive to invent and create, for the progress of science, is so important and widely recognized that it is ingrained in the constitution.228 moreover, this led the supreme court to state: the economic philosophy behind the clause empowering congress to grant patents and copyrights is the conviction that encouragement of individual effort by personal gain is the best way to advance public welfare through the talents of authors and inventors in ‘science and useful arts.’ sacrificial days devoted to such creative activities deserve rewards commensurate with the services rendered.229 actavis keeps this motivation for pioneer manufacturers alive in those settlements not designed to create anticompetitive consequences. if congress completely eliminates or adversely affects the ability of pioneer and generic manufacturers from entering into such agreements, pioneer manufacturers would be less willing to invest billions of dollars into a drug because it would have a decreased chance of protecting its investment. while consumers would be saving money, it would be at the expense of losing new drugs which may improve health and increase life expectancy.230 consumer health and welfare over the long-term is more important to our society as a whole than short-term economic savings.231 as judge easterbrook said, “[a]n antitrust policy that reduces prices by 5 percent today at the expense of reducing by 1 percent the annual rate at which innovations lower the costs of patent introduction would be a calamity. in the long run a continuous rate of change, compounded, swamps static 228 u.s. const. art i, § 8, cl. 8 (“to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”). 229 mazer v. stein, 347 u.s. 201, 219 (1954) (emphasis added). 230 see paul grootendorst et al., the life expectancy gain from pharmaceutical drugs: a critical appraisal of the literature 11 (2007) (discussing how pharmaceutical drugs have contributed to increased life expectancy over the past 50 years). 231 orszag testimony, supra note 225. 2015 rationale behind hatch-waxman act and patent law 467 losses.”232 also, some of the brightest scientists and innovative corporations may not work in or invest in pharmaceutical drugs, a consequence which the constitution and patent law seek to avoid. additionally, the hatch-waxman act attempts to “‘strike a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.’”233 in reality, legislation which in effect works to prohibit reverse payment settlements will contradict the first policy interest behind the hatch-waxman act. further prohibition “would narrow the patent protection provided to branded manufacturers and, on the margin, reduce incentives to invest in new medicines in the future.”234 the second policy interest, bringing low-cost drugs to the market for consumers, was based in the context that procedures for filing a nda under the fdca needed to be revised235 because generic companies would not spend time or money to complete the required clinical trials.236 nothing in reverse payment settlements adversely affects this intent to have more generic drugs in the market by revising procedures for filing a nda. an outright ban on reverse payment settlements would actually increase the time it takes for low-cost drugs to reach consumers. without the availability of settlements, pioneer and generic manufacturers will be forced to litigate matters on the merits and then wait for the results of any appeals. for example, the fda blocked a reverse payment settlement 232 id. (quoting frank h. easterbrook, ignorance and antitrust, in antitrust, innovation and competitiveness 122-23 (thomas m. jorde & david j. teece eds., 1992)). 233 caraco pharm. labs., ltd. v. forest labs., inc. 527 f.3d 1278, 1282 (fed. cir. 2008) (quoting andrx pharms., inc. v. biovail corp., 276 f.3d 1368, 1371 (fed. cir. 2002)). 234 orszag testimony, supra note 225. 235 drug price competition and patent term restoration act of 1984, pub. l. no. 98-417, 98 stat. 1585 (1984). 236 mossinghoff, supra note 20 (citing h.r. rep. no. 98-857, pt. 1 (1984)). 468 indiana health law review vol. 12:1 involving the drug plavix237 which would have allowed the generic drug to reach consumers 10.5 months earlier than it actually did.238 analogous to the hatch-waxman act, the rule of reason, as outlined in actavis, strikes a balance between protecting manufacturers rights while allowing generic drugs to be brought to the market. for instance, by subjecting reverse payment settlements to the rule of reason, settlements which are not intended to prevent low-cost generic drugs from reaching the market will receive the protections afforded under patent law and those having anticompetitive effects will be struck down. as a result, consumers will no longer be burdened with the effects from anticompetitive settlements. analyzing reverse payment settlements under actavis does not impede upon the rationale of patent law or the hatch-waxman act. to the contrary, it supports these rationales. therefore, congress should not act and allow courts to continue analyzing reverse payment settlements under the actavis framework. v. conclusion the supreme court’s correct analysis in actavis provides a useful and workable framework for practitioners to construct reverse payment settlements and for courts to review such settlements. a per se ban on reverse payment settlements or a presumption of anticompetitive harm would be unsupported by the framers of the hatch-waxman act and simultaneously undermines the important motivations provided through patent law. actavis, like the hatch-waxman act, is a compromise between consumers and manufacturers by forcing each to give up something in exchange for something else. consequently, actavis 237 plavix is a branded drug, distributed by bristol-myers squibb, prescribed to treat various aliments related to the heart. medication guide plavix® (plav-iks) (clopidogrel bisulfate) tablets, fda.gov, http://www.fda.gov/downloads/drugs/drugsafety/ucm243349.pdf (last visited nov. 8, 2014). 238 orszag testimony, supra note 225. 2015 rationale behind hatch-waxman act and patent law 469 provides us with a sound approach to analyzing reverse payment settlements, which should rightly be left undisturbed by congress. wendy e. parmet wendy e. parmet is george j. and kathleen waters matthews distin­ guished professor and professor of law at northeastern university school of law and associate dean for academic affairs. she is the author of the populations, public health, and the law, published by georgetown univer­ sity press in 2009 and with professor patricia lliingworth, ethical health care, published by prentice hall in 2005, as well as numerous articles in medical journals and law reviews on public health law, health law, and dis­ ability law. she has taught public health law, health law, disability law, bioethics, torts and constitutional law. professor parmet is a member of the board of directors of health law advocates and health care for all. she is also on the aba' s aids coordinating committee and is a fellow of the american bar foundation. she received her j.d. from harvard law school in 1982 and her b.a. from cornell university in 1979. beyond externships: health law co-ops wendy e. parmet• i. introduction ••••••.•.••...•••••..••••••..•••....•••......•...•.••...•••••..•••••.•.•.••.•.• 401 ii. co-op 101 ...................................................................................... 402 iii. heal1h law co-ops ..................................................................... 403 n. co-op and tile world of practice: a personal view .......... 406 i. introduction for health law students-and their professors-times are good yet worrisome. times are good because of the proliferation of health law pro­ grams, 1 courses, and scholarship,2 not to mention the widening interest in health law spurred by the passage of national health reform and the su­ preme court's review of its constitutionality? in addition, health law is a growing field of practice, meaning that despite the recession, job opportuni~ ties remain. students well skilled in the field have a reasonable expectation of being gainfully employed.4 but times are also troubling because aca­ demic health law cannot be isolated from the growing storms surrounding legal education. for many years, commentators have charged law schools with poorly preparing students for legal practice. 5 that critique has recent* associate dean for academic affairs and george j. and kathleen waters matthews dis­ tinguished university professor of law, northeastern university school of law. 1. as of october 2011, there were at least twelve law schools offering an llm de­ gree in health law (or a closely related fields such as law and medicine), and many more law schools offering a certificate or concentration in health law. research on file with author. in addition, the public health law network reports that as of january 2012, there are twenty­ five accredited schools offering a jdimph program. jd and mph: public health law and the dual degree, the network. for pubuc iiealtii law (aug. 22, 2011 9:46 am), http://www.networkforphl.org/the_network_blog/2011/08/22/58/jd_and_mph_public_health _law_ and_the _dual_ degree. 2. in 2004 mark a. rothstein noted that the growth of "health law and bioethics has been nothing short of amazing." mark a. rothstein, the growth of health law and bioeth­ ics, 14 healtiimatrix2l3, 213 (2004). all signs point to the continued growth of the field in subsequent years. in 2006 henry t. greely surveyed the field of academic health law and noted the increasing numbers of faculty specializing in the area, the wide range of courses, and the mushrooming of health law scholarship. henry t. greely, some thoughts on aca­ demic health law, 41 wake forestl. rev. 391 (2006). 3. florida ex rei. att'y gen. v. u.s. dep't of health & human servs., 648 f.3d 1235 (11th cir. 2011), cert. granted, 132 s. ct. 604 (nov. 14, 2011) (no. 11-398); patient protec­ tion and affordable care act, pub. l. no. 111-148, 124 stat. 119 (to be codified as amended at scattered sections of the internal revenue code and in 42 u.s.c.). 4. see jennifer bard, i'm interested in health law, now where can i get a job?, 14 n.y. statebarass'n j. 73 (2009). 5. see am. bar ass'n, narrowing tile gap-statement of fundamental lawyering skills and professional values (1992) ("maccrate report"); wiluam 402 indiana health law review [vol. 9:2 ly gained popular traction as evidenced by new york times reporter david segal's article charging that law students do "not get, for all that time and money [spent on law school], ... much practical training."6 at a time when students rightly worry about rising debt levels and limited employment pro­ spects, segal's rebuke has a resonance that health law faculty cannot ignore. health law programs have responded to such concerns in a variety of ways. the many innovative health law clinics, externship, and legal­ medical partnerships, some of which are discussed in other contributions to this symposium,7 provide valuable opportunities for health law students to attain critical health law lawyering skills. at northeastern university school of law ("nusl"), we embrace such programs, 8 but also offer a unique program, co-operative legal education, that ensures that all j.d. stu­ dents, in the words of this symposium, go "beyond the classroom."9 alt­ hough nusl's co-op program is not limited to health law-indeed it is a requirement for every jd student-it seems especially well-suited for health law. below i outline some key features of the co-op program. i then tum to health law co-ops, describing what they are and the opportunities, experi­ ences, and skills they offer students. i conclude with some brief personal reflections about some of the unexpected benefits that health law co-ops may provide to health law facu1ty. ii. co-op 101 "co-op" is the term that nusl uses to connote the four full-time, ten to twelve week legal placements that every jd student must complete. the­ se four co-op placements occur during the students' second and third years of law school, and are required in addition to a full complement of academ­ ic credits. thus in contrast to an externship program, students do not take co-ops in lieu of other academic electives. in order to accommodate four co-ops, each nusl class is divided in­ to "rotations" at the end of the first yeru:. two weeks after their spring final m. sullivan et al., educating lawyers: preparation for the profession of law (2007) ("carnegie foundation report"). 6. david segal, what they don't teach law students: lawyering, n.y. times, nov. 19, 2011, at al. 7. see forthcoming 9 ind. health l. rev. (aug. 2012). 8. for example, the law school has a public health law clinic as well as domestic violence and poverty law clinics, both of which expose students to health law problems. students in the jdimph program also do a field placement working for a health provider, regulator, or advocacy organization. 9. drexel university's earle mack school of law also has a co-op program, but it is quite different than northeastern's. in particular, it is not mandatory, lasts only one semes­ ter, and does not rely exclusively on full-time placements. for more information about drexel's program, see hands on learning: the co-op program, drexel univ. earle mack sch. of law, http://earlemacldaw.drexel.edu/academics/co-op/ (last visited may 26, 2012). 2012] beyond ex'rernshjps: heal1h law co-ops 403 exams, half of the class returns to school to commence their upper level studies. the other half goes "on co-op," working full-time in a legal placement, under the supervision of an attorney. students receive a written evaluation of their performance on their co-op which becomes part of their academic transcript. at the end of the summer, the rotations switch. the students who were on co-op return to school; those who were in school go on co-op. all told in 2010, nusl students worked in 812 full-time co-op placements. 10 . one of the hallmarks of the co-op program is the diversity of place­ ments. in 2010, students worked in twenty-eight states and fourteen coun­ tries.11 there were 226 placements in legal services offices, nonprofit advocacy groups, and public defenders offices; 171 placements in govern­ ment agencies; 163 placements with judges, 178 with law firms large and small, and 74 with for-profit or not-for profit organizations.12 some stu­ dents are fortunate to be paid by their employers for the work they do; many others receive subsidies and grants from the law school to support co­ ops with non-profit organizations and government agencies. critically students receive substantial counseling and guidance in or­ der to prepare for their placements. the school's co-op office runs a series of programs throughout the first year that introduce students to different types of legal careers, how to interview for jobs, and how to work on the job. in addition, students receive individual counseling as they apply for and select positions (the school has relationships with over 700 co-op em­ ployers, but students can also ''make their own co-op").13 prior to going on their first co-op, students take a short but intensive "pathways to practice" course introducing them to issues of professional ethics and professional­ ism. ill. health law co-ops co-ops are an integral part of the law school's health law program.14 as health law scholars have noted, the field encomyasses an extremely wide range of complex and seemingly disparate issues. 1 although course offer10. caitlin palm & jeffrey a smith, the cooperative learning model, in guide to pubuc service experiential learning programs in legal education 20-21 (2011), https://pslawnet.orgluploadslfemporary_links/capsils-nalp _public_ service_ experi­ ential_learning_guide_-_november,_201l.pdf(last visited feb. 10, 2012). 11. id. 12. id. 13. id. at 23. 14. much of the discussion below is based on my over twenty-five years ofteaching health law courses at nusl. no studies exist as to the impact of health law co-ops. nusl, however, is currently in the process ofundertaking a rigorous assessment of its overall pro­ gram, focusing in particular on co-op. 15. greeley, supra note 2, at 399. scholars have sometimes bemoaned the particulari­ ty ofhealth law, asking whether it should even rightly be considered to be a true field of law. 404 indiana health law review [vol. 9:2 ings have mushroomed, no law school, and especially no small law school, can offer courses on every aspect of the field, from the law pertaining to assisted reproductive technology to the legal implications of electronic medical records; from global health to the regulation of nursing homes. nor can any law school's clinical program provide students with profes­ sional experiences in all of the different settings in which health law law­ yers practice. extemship programs can provide a broader range of opportunities, but traditionally students are limited to a single extemship. with co-op, in contrast, all students have the opportunity to experience four vastly different practice settings. the health law co-ops that our students have taken in the past several years reflect the field's breadth. 16 for example, students have worked with low-income patients at boston medical center's medical-legal partnership for children, health law advocates, and numerous legal services offices around the nation. students have also worked for many hospitals and health-care provider systems, such as partners health care, the largest pro­ vider network in massachusetts, and winchester hospital, a small commu­ nity hospital. students have also completed co-ops for the health law departments of large law firms, which represent hospitals and insurers, as well as for small and mid-size firms that specialize in medical malpractice or toxic tort cases. co-op students also work for biotechnology companies and the law firms that specialize in biotech and pharmaceutical law. in ad­ dition, students work for public health and healthcare regulatory agencies, at the municipal, state, and federal levels. given nusl's commitment to public interest law, it is not surprising that many of our students chose to work for non-governmental organizations ("ngos") that advocate on a va­ riety of social justice issues, including hn/aids, reproductive rights, en­ vironmental justice, and health and human rights. in all of these different settings students may and usually do encounter health law issues that are not generally covered in the law school's curriculum. the design of the co-op program promotes a self-directed, iterative approach to education that allows health law students to select a path re­ flecting their own interests and securing their own professional develop­ ment although many students only do one health law co-op, others opt to do several.17 by working for very different co-op employers, students have see, e.g., mark a. hall & carl schneider, where is the "there" in health law? can it be­ come a coherent field?, 14 health matrix 1 01 (2004 ). 16. reflecting the reality of practice, the law school's co-op office does not fonnally designate or count co-ops by area of practice. after all, students working in a legal services office may find that they spend either a great deal or very little of their time on a health law issue. likewise students who work for a hospital may find that they end up working primari­ ly on issues that do not require much knowledge of health law. the fact that lawyers who represent health care providers often work on issues not relating to health law is one im­ portant lesson that co-op offers students. 17. almost none of our students will do four health law co-ops. we discourage such specialization and urge students who believe that they want to work in health law to take at 2012] beyond externships: health law co-ops 405 the opportunity to learn about and taste the myriad ways that lawyers prac­ tice health law, while adding progressively to their practice skills. some­ times those experiences change a student's decision as to what type of work he or she wants to do upon graduation. other times, a co-op experience reaffirms a student's interest in a particular area. some students then choose to specialize, doing two or more co-ops in a particular sub-area of health law, such as working for two different medical malpractice firms or several health and human rights ngos. all students in the law school's jd/mph program (with tufts univer­ sity school of medicine) are required to do at least one "public health law co-op," a category that is interpreted very loosely to encompass almost any co-op that exposes to students to issues of health or public health law. each year the students graduating from the program must write a brief capstone paper, reflecting upon their experiences in the program and the different skills and perspectives that they have gained from studying two different professions. these papers offer an illuminating window into the value of health law co-ops. almost without exception, students remark on the chal­ lenges they faced and the new skills they developed during their health law co-ops. they frequently note that their co-ops offered them the opportunity to integrate the academic lessons and professional values they were taught in their two different degree programs. for faculty the value of health law co-ops is constantly evident in the classroom. perhaps because many students in a health law course will have either just finished working on a health law co-op or are in the process of looking for one, our health law students tend to be extremely engaged par­ ticipants in classroom discussions. indeed, the iterative process promoted by the students' rotation between co-op and school underscores to the stu­ dents the relevance of what they are learning in their health law classes. many students seem to relish theoretical discourse in part because it pro­ vides them with the opportunity to reflect upon and make sense of the work they have just completed on co-op. class discussions are frequently enhanced because our health law stu­ dents bring a plethora of different vantage points to the classroom. in a class about health reform, for example, i am apt to have students who have worked for consumer health advocacy groups such as health care for all, students who have worked for large health care providers, such as partners health, and students who have worked for insurers and federal regulators. because these students have represented different players in the health care system, they can proffer different perspectives on the policy issues that we discuss, as well as different views as to how health reform will impact health law practitioners. a similar pattern has occurred in my public health least one co-op in a different field. moreover a very large percentage of students opt to do at least one judicial clerkship, believing that it will give them an unparalleled opportunity to hone their legal research and writing skills. 406 indiana health law review [vol. 9:2 law courses. whether the topic is hn/aids or tobacco control, i've al­ most always had students who have represented different stakeholders. the result is a rich discussion not only about the legal and policy implications of the topic at hand, but also about the challenges and conflicts that health law lawyers face as they represent different types of clients. n. co-op and the world of practice: a personal view the discussion thus far has emphasized how co-op by taking students outside of the academy enriches their education and skill development. the title of this symposium, however, points to a different issue: how do health law faculty interact with the outside world? to answer that question in an essay on health law co-ops, let me conclude with some personal observa­ tions. as a health law professor, i have always viewed my own career, as i know many other health law professors have, as rooted in both theory and practice. indeed, i have long felt that health law, founded as it is on a set of vital human needs and complex social institutions, rather than abstract ques­ tions of legal doctrine, is particularly suited to scholars who wish to remain engaged in the "real world." personally, the co-op program has helped me to do so. one way co-op has tied me to the world outside the academy is by forcing me to stay abreast of the type of practice issues that students bring to class. after all, if my students are apt to share their practice experience in the classroom, i had better keep up with what health law lawyers are ac­ tually doing. but co-op has also helped me to meet and interact with the many health law practitioners who supervise my health law students. for example, in the late 1990s my research assistant, daniel jackson, was work­ ing on co-op for the aids law project of the gay and lesbian advocates and defenders in boston. there he worked on a disability discrimination case involving a woman who was denied dental care because of her hn status. jackson told his supervisor, bennett klein, that i had done research relevant to the issues arising in the case and that we should meet. we did. as a result, i ended up having the opportunity to serve as co-counsel in bragdon v. abbott, 18 the supreme court's first hn discrimination case. of course, most of the time, the interactions spawned by co-op don't lead to working on a supreme court case. but many less notable invitations to go outside of the academy occur regularly, as students bring not only their ex­ periences but also their contacts back to the law school. most important, however, is the environment that co-op fosters. as an integral part of nusl, co-op helps to nurture an atmosphere that encour18. bragdon v. abbott, 524 u.s. 624 (1998) (holding that an individual who was hiv positive had a disability within the meaning of the americans with disabilities act). 2012] beyond externships: health law co-ops 407 ages a deep respect for the practice of law, especially on behalf of the pub­ lic interest. it is this ethos that has permitted if not encouraged me to join my students in rotating back and forth between the academy and the world of practice. whether this has made me a better scholar or teacher, i leave to others to assess. i do know it has made for a more rewarding life as a health law professor. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i attorneys, tell your clients to say they're sorry: apologies in the health care industry robin e. ebert* table of contents i. introduction ..................................................................................... 338 ii. communication in the physician-patient relationship ........... 340 iii. why physicians hold their tongues .......................................... 341 a. fearoflitigation ...................................................................... 342 b. the patient ................................................................................ 343 1. expectations ........................................................................ 343 2. misinterpretations ............................................................... 343 3. disclosing the error ............................................................ 343 c. personal character ................................................................... 344 1. ego and the suppression of apology .................................. 344 2. nature of the profession ...................................................... 345 n. it is better to be sorry than safe ............................................. 346 a. state legislation regarding expressions of sympathy ............. 346 1. the massachusetts approach .............................................. 346 2. reasoning for legislation ................................................... 347 3. legislative trends ............................................................... 348 b. in the courtroom ....................................................................... 349 1. case law ............................................................................. 349 2. effect of apologies in litigation. ......................................... 351 c. scholarly studies ....................................................................... 3 51 1. the robbennolt study ......................................................... 351 2. the vincent study ................................................................ 352 3. the gallagher study ........................................................... 352 d economic benefits to protecting apologies ............................... 353 1. preventing litigation .......................................................... 353 2. encouraging settlement discussions .................................. 354 e. case studies .............................................................................. 354 1. veterans affairs medical center in lexington, kentucky ............................................................................ 354 2. physicians reimbursement fund ........................................ 355 3. how the cop/c insurance company encourages * j.d. candidate, 2008, indiana university school of lawindianapolis; b.a. 2005, depauw university. 338 indiana health law review [vol. 5:337 physicians to apologize ..................................................... 356 v. fault-admittlngapologies vs. expressions of sympathy ...... 357 a. d(fferences among the states .................................................... 357 b. benefits of protecting fault-admitting apologies ..................... 357 c. potential disadvantages of protecting fault-admitting apologies .................................................................................. 359 vi. the actual apology ...................................................................... 360 a. definition of "apology" ............................................................ 360 b. presentation of an apology ....................................................... 360 1. who should give the apology? ........................................... 361 2. what can and cannot be said? .......................................... 361 3. when should the apology be given? .................................. 362 4. advising how to apologize ................................................. 363 c. sincerity and ulterior motives .................................................. 363 vii. is saying"i'm sorry"enough? .................................................... 364 a. where 's the proop. .................................................................... 364 b. potentia/for problems .............................................................. 365 1. explanations of error ......................................................... 365 2. whose advice should the doctor take? ............................. 365 vill. conclusion .................................................................................... 366 appendix 1: summary of state "i'm sorry" laws ............................ 366 i. introduction parents teach their children at an early age to apologize when they have done something wrong. it is an intrinsic characteristic of human behavior taught to us at a young age.1 there is some indication, however, that this at­ tribute does not readily translate into adulthood. "[the concept of apology] is something every eight-year old knows, yet somehow it tends to be swallowed up during adult ... discussions of law and business ... 2 after bumping into someone on the street, most people will apologize to the complete stranger without giving it a second thought. 3 apologizing in the wake of a medical er­ ror, however, is not a common practice among physicians. the same doctor who apologizes to a stranger on the street is likely to hesitate before offering his or her patient an apology following a medical error.4 l. donna l. pavlick, apology and mediation: the horse and carriage of the twenty­ first century, 18 omo st. j. on disp. resol. 829, 837 (2003). 2. hiroshi wagatsuma & arthur rosett, the implications of apology: law and culture in japan and the united states, 20 law & soc'yrev. 461,493 (1986). 3. pavlick, supra note 1, at 848. pavlick uses the term "automatic apology" to describe this type ofbehavior. 4. /d. pavlick comments that "culture dictates the circumstances in which apologies are used," and apologies are not generally "automatic" when there are potential legal implications. /d. 2008] apologies in the health care industry 339 apologies are generally viewed as common courtesy. if a person fails to apologize, the injured party may feel that the wrongdoer is not remorseful. 5 conversely, when someone apologizes, the person who has been injured may view the apology as an admission of wrongdoing. when contemplating wheth­ er to apologize for doing something wrong, the wrongdoer may feel vulnerable "to some potentially bad consequences stemming from the apology itself. this tends to make people reluctant to apologize, often to their own detriment.',() physicians are particularly reluctant to apologize for fear that their expression of sympathy could serve as evidence of an admission of liability in a medical malpractice lawsuit. as such, the physician is torn between the instinctive sympathetic response and the fear of an impending lawsuit. this form of self­ preservation on behalf of physicians is detrimental to all parties involved in the medical error. in a nation where the vast majority of states currently suffer from a medi­ cal malpractice liability crisis or are on the verge of a crisis, 7 it is the responsi­ bility of doctors and patients alike to do what they can to reduce the risk of medical malpractice litigation. studies suggest8 and the recent flood oflegisla­ tion protecting physicians' extrajudicial statements confirms that communica­ tion between physicians and patients can help ease the tension of looming litigation. nevertheless, physicians are still hesitant to offer apologies to their patients. this note will explore the usefulness of apologies in the field of medicine and the value that they provide to both the physician and patient. section ti explains the integral role communication plays in the physician-patient relation­ ship. section iii explains the reasoning and rationalization as to why physi­ cians and other medical professionals are hesitant to offer expressions of sympathy to their patients. section n discusses the current safeguards in place that protect physicians who offer apologies to their patients and describes the mutual benefits of apologies, in both a moral and a legal context. section v 5. bill plaschke, she turned down millions for justice for her son, la. times, aug. 2, 2005. the article describes a situation in which linda will, mother of the deceased rashidi wheeler, refused to accept a $16 million judgment until she received an explanation and apol­ ogy from northwestern university for the death of her son. linda will wanted this question answered: "is it too much for a mother to ask why her son died, and why won't somebody apologize for it?" id. 6. peter h. rehm & denise r. beatty, legal consequences of apologizing, 1996 j. disp. resol. 115, 115 (1996). 7. am. med. ass'n, america's medical liability crisis: a national view (jan. 2007), http://www.wisconsinmedicalsociety.org/_ wms/communicationlpress _ release/med _1iab _jan07 .pdf. the map indicates that approximately half of the country is either in a state ofmed­ icalliability crisis or on the verge of a liability crisis. !d. 8. charles vincent & magi young, why do people sue doctors? a study of patients and relatives taking legal action, 343 lancet 1609, 1612 (1994). this study surveyed 227 patients and their families who were seeking legal remedies following an adverse medical out­ come. the study indicates that the patients and their families decided to take legal action not only because of the original injury, but also because of the insensitive handling and poor com­ munication after the original incident; see infra pp. 23-26. 340 indiana health law review [vol. 5:337 analyzes the difference between mere expressions of sympathy and fault­ admitting apologies. this section also discusses the potential benefits and det­ riments of endorsing fault-admitting apologies. section vi dissects the apology itself and the potential problems that may accompany widespread use of apolo­ gies in a health care setting. section vii discusses measuring the effect of apologies in the health care industry and the potential ramifications of wide­ spread use. section viii concludes that physicians should utilize apologies to heal both the physical and emotional injuries a patient experiences from an ad­ verse medical outcome, thereby benefiting all parties involved. ii. communication in the physician-patient relationship a healthy physician-patient relationship requires a foundation of open and honest communication. the exchange of dialogue between a physician and his or her patient is a fundamental attribute of the relationship.9 a patient places faith in his or her physician's skills, while the physician places faith in his or her patient to follow the recommended treatment. the american medical as­ sociation ("ama") code ofethics regarding the physician-patient relationship states: "the relationship between patient and physician is based on trust and gives rise to physicians' ethical obligations to place patients' welfare above their own self-interest and above obligations to other groups, and to advocate for their patients' welfare. "10 when there is a failure to communicate, problems are likely to ensue. 1 1 communication plays an integral role at every stage of the physician­ patient relationship. prior to treatment, patients rely on the provision of ade­ quate information in order to make an informed decision regarding the course of their medical treatment. the ama code ofethics provides that a "physi­ cian has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. " 12 as such, the communications that take place between the physician and the patient are the 9. am. med. ass'n, code of medicaletiiics oftheamericanmedicalassociation, 10.01 fundamental elements of the patient-physician relationship 311-16 (2006-2007). this provision of the ethical code states that a "patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives ... to have their questions answered ... and to receive independent professional opinions." !d. 10. am". med. ass 'n, code of medical etiiics of the american medical association, 10.015 the patient -physician relationship 317 (2006-2007). 11. ashley a. davenport, note, forgive and forget: recognition of error and use of apology as preemptive steps to adr or litigation in medical malpractice cases, 6 pepp. disp. resol. l.j. 81, 83 (2006) (suggesting that when there is a continued lack of communication, the patient begins to believe that "the physician does not listen, does not speak openly, attempts to mislead the family and does not warn about long-term problems."). 12. am. med. ass'n, code of medicaletiiics oftheamericanmedicalassociation, 8.08 informed consent 227-31 (2006-2007). there are, however, exceptions to this require­ ment if(l) the patient is unconscious and unable to consent to treatment or if(2) disclosing information would pose a risk of detriment to the patient's psychological state. ld. 2008] apologies in the health care industry 341 first step to building and strengthening the relationship. a patient who feels comfortable in communicating with his or her physician is likely to have a bet­ ter relationship with that physician. just as the conversations prior to treatment are vital, the communications that transpire between physicians and their patients after treatment are of equal importance. a physician's duty to follow-up with patients does not simply ex­ tend to successful treatment. the ama code ofethics also suggests that in the wake of medical error, patients have a right know what happened. 13 specifi­ cally, the code of ethics states that "[ c ]on cern regarding legal liability which might result following truthful disclosure should not affect the physician's hon­ esty with a patient."14 communications that follow an adverse outcome are a topic of heated debate among attorneys, risk management directors, medical malpractice insurance carriers, and physicians themselves. what the conversa­ tion should encompass and whether an apology should be offered to the injured party are of special concern. instinct, morality, and public opinion suggest that communications incorporating an apology may be essential to mending a physi­ cian-patient relationship following an adverse outcome.15 iii. why physicians hold their tongues the american college ofphysician executives conducted a study in 2006 titled "patient trust and safety survey. " 16 the study surveyed 1018 physician­ members of the american college of physician executives. 17 the study sug­ gests that the vast majority of physicians surveyed believed that apologies should be given to patients following a medical error. 18 "over and over, the adjectives 'right,' 'ethical' or 'honorable' were used to describe a broad convic13. am.med.ass'n,codeofmedicaletiucsoftheamelucanmedicalassociation, 8.12 patient information 240-41 (2006-2007). the code states that when "a patient suffers significant medical complications that may have resulted from the physician's mistake or judg­ ment . . . . [t]he physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred." /d. 14. /d. 15. the concept of public opinion regarding apologies is not exclusive to the medical arena. ceos oflarge companies have utilized public apologies as a means to regain the trust of their clients and consumers. see pamela j. vaccaro, putting politeness into practice, 9 f am. prac. mgmt. 70, 70 (apr. 2002), available at http://www.aafp.org/fpm/20020400/70putt.html (last visited mar. 31, 2008) (comparing the responses of two ceos following unfortunate busi­ ness practices). the ceo offord motor company spent billions of dollars to replace defective tires, but did not offer an apology. conversely, the ceo of united airlines publicly apologized for the airline's inability to get passengers to their destinations on time, but did not offer any sort of compensation. a public poll was conducted, and the ceo of united airlines was the favored ceo because "[h]e said he was sorry." /d. 16. david oilier weber, who'ssorrynow?,physicianexecuti:ve,mar.&apr.2006,at 6. 17. /d. at 10. 18. /d. in response to the question: "in your opinion, do you believe health care organi­ zations should encourage making apologies for medical errors?'' eighty-one percent of the phy­ sicians said "yes," four percent said "no," and sixteen percent said "not sure." /d. 342 indiana health law review [vol. 5:337 tion that disclosure/apology is essential."19 thus, the question remains as to why physicians continue to avoid showing remorse and offering expressions of sympathy following an adverse medical outcome. a. fear of litigation the primary argument physicians provide for abstaining from apologies is the fear of an impending lawsuit. 20 "[e]ven if an apology is the morally right thing to do, attorneys often will counsel their clients not to apologize because a misunderstanding about liability can disrupt insurance negotiations and effect [sic] the amount of money the offender may have to pay. "21 if physicians are told that their expressions of sympathy may be used against them in a medical malpractice lawsuit or that it may jeopardize insurance coverage, the physician will undoubtedly be reluctant to apologize. 22 the subsequent effort to try and avoid "legal suicide"23 contradicts human intuition and promotes an atmosphere of silence. the federal rules of evidence have furthered physicians' reluctance to apologize to their patients. these rules have completely disrupted physicians' ethical and instinctual responses to adverse outcomes. rule 408 of the federal rules of evidence provides an exception to the hearsay rule, stating that an ex­ pression of sympathy offered by the wrongdoer outside of settlement negotia­ tions or mediation may not be protected and may be admissible evidence. 24 as such, this rule permits expressions of sympathy to be used against physicians in legal proceedings, thereby fostering their aversion to apologies. the federal rules of evidence contain an additional exception to the hearsay rule, stating that"[ a] statement relating to a startling event or condition made while the declarant was under the stress of excitement caused by the event or condition" is not excluded by the hearsay rule.25 this rule provides another reason why physicians may be hesitant to offer their sympathy. apolo­ gies are often given as a moral reflex, 26 but this rule, accompanied with the se­ verity of the situation, may hinder such an instinct. 19. id. at 13. 20. pavlick, supra note 1, at 853; see also weber, supra note 16, at 12 ("the most com­ mon reason cited for continuing the practice of stonewalling when a medical mistake occurs was simply put by an illinois group practice head: 'apologies ... for medical errors are used against you in court."'). 21. pavlick, supra note 1, at 854. 22. weber, supra note 16, at 6. one ofthe physician's surveyed commented "although i believe that apologies should be made ... our l~wyers and risk management personnel are very much against it and block us from doing it." id. (quotation in original). 23. daniel eisenberg, when doctors say, "we're sorry," time, aug. 15,2007, at 50. 24. fed. r. evm. 408; see also jennifer k. robbennolt, apologies and legal settlement: an empirical examination, 102 mich. l. rev. 460, 466 (2003). 25. fed. r. evid. 803(2). 26. pavlick, supra note 1, at 848 (referencing the term "automatic apology"). 2008] apologies in the health care industry 343 b. the patient 1. expectations the way in which an expression of sympathy is phrased has a tremendous impact on the recipient's interpretation. apprehension on the part of the physi­ cian and expectation on the part of the patient can lead to misunderstood com­ munications. "[i]f the receiver expects an authentic apology, and the giver offers only an excuse or explanation for his or her behavior ... forgiveness is not likely to occur. in fact, the receiver, whose expectations are not met, may experience increased anger toward the giver.'m as such, a patient who does not receive the response he or she was expecting may leave feeling resentful and more likely to desire taking legal action against the physician. 28 2. misinterpretations in addition to being angered, a patient who expects to hear a particular sentiment from his or her physician may subconsciously misinterpret what the physician actually said in order to make the statement conform to his or her ex­ pectations. "[t]he relational process between both parties may lead to a misun­ derstanding of what was intended to be communicated by the apology."29 for example, a physician may say to his or her patient, "i'm sorry this happened to you," but the patient, believing the physician owes him or her an apology and an explanation may hear, "i'm sorry i did this to you." while the former state­ ment is a mere expression of sympathy, the latter connotes an admission of fault. this slight variation in wording can be detrimental for the physician. 30 this miscommunication may also result in a "he said, she said" situation, where it may be difficult to determine what the parties communicated. 3. disclosing the error in some cases, the provider knows a medical error occurred, but the pa­ tient is unaware of this fact. in this situation, the provider has to decide not only whether or not to apologize, but whether the error should be disclosed to the patient in the first place. according to ama ethical policy, the physician 27. !d. at 850. 28. virginia l. morrison, heyoka: the shifting shape of dispute resolution in health care, 21 ga. st. u. l. rev. 931, 947 (2005). "studies documentthat the failure to meet these expectations, or poor communication in meeting them, can be perceived as measures of disre­ spect and may inflict as much or more pain than the injury, serving as the catalyst for taking legal action." !d. 29. william k. bartels, the stormy seas of apologies: california evidence code section 1160 provides a safe harbor for apologies made after accidents, 28 w. st. u. l. rev. 141, 150 (2000-2002). 30. see i,yi-a p. 31. 344 indiana health law review [vol. 5:337 has a duty to disclose the error to the patient31 nevertheless, physicians are reluctant to disclose error due to the potential professional and legal ramifica­ tions. according to the american society of law, medicine and ethics, being honest with the patient is the best means of preventing litigation and maintain­ ing the physician-patient relationship. 32 "[a ]11 types of errors should be dis­ closed to the patient, not only because the patient has a right to know, but also because good evidence exists that transparency enhances the health care pro­ vider-patient relationship. "33 evidence also suggests that physicians who try to cover up their errors are the most likely to be sued. 34 c. personal character overall, the public holds the practice of medicine in high regard. indi­ viduals who want to become doctors spend a large portion of their lives trying to achieve that goal. it takes a particular type of person to join the ranks of those who practice medicine, including particular personal attributes that may make it difficult for some to inc01porate apologies into the course of their pro­ fession.35 aside from potential legal implications, there are two primary rea­ sons why physicians may fmd it difficult to apologize to their patients: ego and the nature of the profession. 1. ego and the suppression of apology aside from intelligence, physicians tend to have certain personal charac­ teristics that set them apart from others in society. though not an exhaustive list, some of these characteristics include confidence, competitiveness, and de­ termination. while these attributes may not apply across the board, they are some of the common qualities physicians possess that can unfortunately serve as stumbling blocks when it comes to apologizing. 31. am. med. ass'n, code of medical ennes oftheamericanmedicalassocjation, 8.12 patient information 240-41 (2006-2007). 32. see william winslade & e. bernadette mckinney, to tell or not to tell: disclosing medical error, 34 j.l. med. & ennes 813, 813 (2006). 33. id. 34. weber, supra note 16, at 10. the study also surveyed 1008 adults representing past or future patients. in response to the question, "suppose you or a family member were the victim of a medical error and the doctor or hospital that made the mistake tried to hide it; would you be more or less likely to sue?" ninety-two percent of respondents said they would be ''more likely'' to sue. when asked if they would be more likely or less likely to sue if''the doctor or hospital that made the mistake personally apologized," twenty-five percent of the respondents said ''more likely" and fifty-seven percent of the respondents said "less likely." id. 35. see generally aaron lazare, go ahead say you're sorry, psychol. today, jan. & feb. 1995, at 40. lazare suggests that apologies are "antithetical to the ever-pervasive values of winning, success, and perfection. the successful apology requires empathy and the security and strength to admit fault, failure, and weakness." /d. 2008] apologies in the health care industry when making an apology, the giver must acknowledge that he or she made a mistake by failing to meet his or her own standards or by failing to live up to the values ofthe moral community. worse than the acknowledge­ ment offailure is fear of the shame that accompanies the admission. pride may keep many individuals from being able to apologize.36 345 in addition to the fear that potential litigation might result from an apolo­ getic statement, apologizing to one's patient also carries with it the burden of acknowledging the mistake. 2. nature of the profession at a minimum, an apology may be defined as an admission that there was an error and harm ensued. although the person expressing the sympathy may not be the one who directly caused the error, it is nevertheless difficult to admit that something went wrong during the course of medical treatment. 37 "we all find it difficult to 'fess up,' but it's even harder when your error has caused someone significant physical harm."38 physicians place a certain amount of pressure on themselves to live up to the ideals society has envisioned for them. 39 to admit the existence of an error and to subsequently apologize for it "exposes a chink in that m.d. armor. and if their errors cause serious harm, doctors can feel profound shame and guilt."40 studies indicate, however, that patients realize doctors cannot guarantee medical outcomes. the study con­ ducted by american college of physician executives demonstrates that in re­ sponse to the following two statements, "[m]edical science is so advanced that medical errors should be very rare," and "medical science is so complex that medical errors are bound to happen," forty-three percent of patients responded "very rare," fifty-three percent of patients responded "bound to happen," and four percent did not know.41 accordingly, individual patients and society in general are more forgiving than physicians may presume, but ultimately, a pa­ tient's forgiveness is dependent on adequate communication. 36. pavlick, supra note 1, at 852-53. 37. see lazare, supra note 35, at 78. "to apologize, you have to acknowledge that you made a mistake. you have to admit that you failed to live up to values like sensitivity, thought­ fulness, faithfulness, fairness, and honesty. this is an admission that our own self-concept, our story about ourself, is flawed. to honestly admit what you did and show regret may stir a pro­ found experience of shame, a public exposure of weakness." id. 38. lucian leape, disclose, apologize, explain, newsweek, oct. 16,2006, at 50. 39. !d. the author states that "many physicians still cling to the misguided notion that they need to appear infallible to gain patients' trust and confidence." 40. id. 41. weber, supra note 16, at 11. 346 indiana heal til law review [vol. 5:337 n. it is better to be sorry than safe a. state legislation regarding expressions of sympathy a majority of state legislatures have taken steps to ensure that expressions of sympathy are not considered admissible evidence. 42 these laws have devel­ oped from the basic premise that "[t]he law should not punish people for taking a moral step.'.43 this legislation varies from state to state in regard to the spe­ cific language that receives protection, the way in which the physician conveys the apology, and whether the apology's inclusion of an admission of fault. in­ diana enacted such legislation in the summer of2006, protecting expressions of sympathy relating to "(1) a loss; (2) an injury; (3) pain; (4) suffering; (5) a death; or ( 6) damage to property'' :from being admitted into evidence. 44 ques­ tions remain as to what effect the variety of state legislation will have on medi­ cal malpractice claims, how apologies will be viewed after such legislation has been enacted, and how the laws will affect the way in which physicians deal with adverse outcomes. 1. the massachusetts approach in 1986, massachusetts enacted the first state legislation designed to pro­ tect apologies offered following an accident :from being entered as evidence to prove liability. 45 the legislation originated :from a retired massachusetts legis­ lator whose daughter was struck by a car while riding her bicycle. "her father, a state senator, was angry that the driver had not expressed contrition. he was told that the driver dared not risk apologizing, because it could have constituted an admission in the litigation surrounding the girl's death."46 in response to this incident, the senator drafted a bill that would protect wrongdoers who apo­ logized and showed remorse for their actions. the massachusetts law protects expressions of sympathy "or a general sense of benevolence relating to the pain, suffering or death of a person in­ volved in an accident and made to such person" :from being admissible "as evi­ dence of an admission of liability in a civil action.'.47 this legislation does not reference the admissibility of communicating fault. as such, it remains unclear whether the law protects fault-admitting expressions of sympathy. although massachusetts legislators did not design the language of this state law with as 42. see infra appendix 1 [hereinafter app. 1]. 43. jonathanr. cohen, legislating apology: theprosandcons, 70u.cin.l.rev. 819, 864 (2002). 44. ind. code§ 34-43.5-1-4 (2007). 45. see cohen, supra note 43, at 827; see generally mass. gen. laws ann. ch. 233, § 23d (west 2007). 46. cohen, supra note 43, at 827. 47. ch. 233, § 23d. 2008] apologies in the health care industry 347 much specificity as seen in some other state legislation, they nevertheless set the stage for the future protection of apologies. 2. reasoning for legislation physicians who commit errors are likely to forgo an apology or expression of sympathy out of fear that it might be held against them in court.48 laws that protect those who offer apologies in the wake of an error will not only benefit the parties directly involved, but the laws will also promote an atmosphere of open communication. serving as the foundation of a physician-patient relation­ ship, the presence of open communication may lessen the chance that the in­ jured party will file a lawsuit.49 gerald b. hickson, m.d., vice chair of pediatrics at vanderbilt university conducted a study in 1992 that demonstrated a strong correlation between malpractice suits and communication issues.50 the study indicated that people primarily filed a lawsuit against their physician because they felt that the "physicians covered up facts, did not provide re­ quested information, did not listen when asked questions or attempted to mis­ lead them."51 through the drafting and enacting of legislation that protects such communication, legislators possess the power to potentially decrease the incidence of malpractice claims arising from poor communication. apologies may be necessary not only for the injured party, but also for the person who may have caused the harm. 52 offering and accepting an apology serve as the basis for the healing process on behalf of both parties involved, providing condolences to the injured and a sense of closure to the injurer. in addition, laws protecting expressions of sympathy benefit more than just those working in the medical field. "embracing apology is really part of a broader social movement to treat others with respect and directly take responsibility for one's actions. "53 by passing legislation that protects expressions of sympathy, the state is urging adverse parties to engage in conversations in which the in­ jurer can convey his or her regret and sympathy without fear of imminent liabil­ ity.54 48. jonathan r. cohen, advising clients to apologize, 72 s. cal. l. rev. 1009, 1028 (1999) (stating that "it is liability, or the fear ofliability, that forms the central barrier to apology in most disputes."). 49. see linda 0. prager, new laws let doctors say "i'm sorry"for medical mistakes, amnews, aug. 21, 2000, http://www.ama-assn.orglamednews/2000/08/21/prsa0821.htm (last visited mar. 20, 2008). 50. andis robeznieks, being open may avoid lawsuits, amnews, june 10, 2002, http://www.ama-assn.orglamednews/2002/06/10/prsb0610.htm (last visited feb. 20, 2008). hickson gathered the results from interviews of 127 florida families claiming perinatal injury. !d. 51. !d. 52. see rehm & beatty, supra note 6, at 116; see also cohen, supra note 48, at i 021. 53. cohen, supra note 43, at 850. 54. see id. at 855. 348 indiana health law review [vol. 5:337 3. legislative trends since the inception of the massachusetts law in 1986, a flood oflegisla­ tion from states across the nation protecting apologies has emerged in the health care field and others. there are currently thirty-two states that protect expres­ sions of sympathy from being admissible evidence. 55 in 2003, oregon and colorado enacted legislation that protected expressions of sympathy specifically in a health care setting from being entered into evidence. 56 the majority of state legislation protecting expressions of sympathy falls under rules of evi­ dence pertaining specifically to medical error. 57 a number of states, however, have protected communications of sympathy from being admitted into evi­ dence, regardless if the adverse outcome resulted from the practice of medicine or not. 58 additionally, some state laws provide specific guidance as to when the protection applies. for example, the law in georgia protects expressions of regret and mistake generally, but specifically encourages such communication to take place between health care providers and their patients. 59 states that have passed legislation protecting apologies in the last couple of years have traditionally utilized language that closely resembles the language originally developed by the states that pioneered "i'm sorry" legislation. physicians and attorneys, however, should be cautious when interpreting the applicable state law. minor differences in the wording of a statute can have a dramatic effect on what a court deems admissible evidence. 60 though the differences in statu­ tory language may initially appear trivial, physicians must recognize what con­ stitutes a protected apology under their specific state law. 55. see am. med. ass'n, advocacy res. ctr., i'm sorry laws: summary of state laws (jan. 2007), http:/ /www.ama-assn.org/ama/pub/category/74 70.html (on file with the au­ thor); see infra app. i. 56. ansley boyd barton, recent remedies for health care ills, 21 ga. st. u. l. rev. 831, 846-47 (2005). 57. see infra app. 1. 58. see infra app. 1. currently, eight states have enacted legislation that protects expres­ sions of sympathy generally and does not limit the protection to specific communications fol­ lowing medical error. 59. see ga. code ann.§ 24-3-37.l(a) (west 2007). 60. for example, the law in tennessee, adopted in 2003, and the law in missouri, adopted in 2006, utilize very similar language. the missouri statute, however, excludes the phrase "in­ volved in an accident" and it only protects expressions of sympathy arising from improper health care. the tennessee statute, on the other hand, protects all expressions of sympathy. compare tenn. code ann.§ 409.1 (2006) with mo. rev. stat.§ 538.229 (2006). 2008] apowgies in the health care industry 349 b. in the courtroom 1. caselaw seeing that fear of litigation is physicians' primary reason for abstaining from offering apologies to their patients, it is helpful to consider decisions courts have made in the past. "no matter how many times doctors, hospital administrators, attorneys and malpractice insurers are told so, they still have a hard time believing that there has yet to be a case in which an apology was used as evidence and made a difference in the outcome ... .'.61 given the large number of cases that end up in settlement or dismissal, little case law exists on this particular subject. nevertheless, the cases discussed below demonstrate that the use of apologies and other extrajudicial statements made by the physi­ cian following a medical error are not alone sufficient to prove negligence. one of the most frequently referenced opinions regarding extrajudicial statements made by a physician following an adverse outcome is lashley v. ko­ erber.62 in this case, the physician failed to take an x-ray of the patient's finger in a timely manner, resulting in further damage. 63 according to plaintiff's tes­ timony, once the physician realized his error, he said, "i know, it is not your fault, mrs. lashley, it is all my own. "64 the court decided to reverse the lower court's decision to grant the defendant's motion for nonsuit, finding that the statement was sufficient to establish that the issue of the physician's negligence should be decided by ajury.65 the court acknowledged, however, that "[a]n extrajudicial admission of 'fault' ... may amount to no more than an admission of bona fide mistake or misfortune and thus be insufficient to establish negli­ gence.',(j6 the supreme court of california revisited the issue of extrajudicial statements made by physicians twenty-seven years later in cobbs v. grant. 61 in response to the plaintiff alleging that the physician told him that "he blamed himself for me being back in there [the hospital for a second time]," the court stated: [e]ven if the jury had chosen to believe plaintiff, defen­ dant's statement signifies compassion, or at most, a feel­ ing of remorse, for plaintiff's ordeal. since a medical doctor is not an insurer of result, such an equivocal ad­ mission does not constitute a concession that he lacked 61. eisenberg, supra note 23, at 50. 62. lashley v. koeber, 156 p.2d 441 (cal. 1945). 63. /d. at 442. 64. id. 65. id. at 445. 66. id. 67. cobbs v. grant, 502 p.2d 1 (cal. 1972). 350 indiana health law review or failed to use the reasonable degree of learning and skill ordinarily possessed by other members of the pro­ fession in good standing in the community, or that he failed to exercise due care. 68 (vol. 5:337 california passed its "i'm sorry'' law in 2003, excluding any statement or ges­ ture expressing sympathy offered to the victim following an accident. 69 the supreme court of vermont also addressed the issue of extrajudicial statements in senesac v. associate in obstetrics and gynecology. 70 there the patient sued the physician for medical negligence following an abortion proce­ dure. 71 the physician's motion for directed verdict was granted, because the patient failed to offer expert testimony to show the physician lacked the "requi­ site care and skill as is required."72 the patient tried to demonstrate that the physician's statement that she "made a mistake, that she was sorry, and that it had never happened before" was sufficient to prove negligence. 73 the court denied the patient's argument, stating: it is conceivable that in some circumstances the extraju­ dicial admission of a defendant physician could establish a prima facie case of negligence in a medical malpractice action .... the asserted statement of dr. gray ... does not establish a departure from the standard of care ordi­ narily exercised by a reasonably skillful gynecologist. 74 the supreme court ofv ermont echoed a similar sentiment in phinney v. vinson/5 in which the court held that the physician's apology for failing to per­ form an adequate resection for the patient's prostate was "insufficient to meet plaintiffs' burden" ofproot:16 as the aforementioned cases evince, even if a patient does take his or her doctor to court, the use of an apology to prove negligence is not likely to pass muster. 77 although each court may differ in its characterization of a defen 68. ld. at6. 69. see cal. gov't code § 11440.45 (west 2007). 70. senesac v. assocs. in obstetrics & gynecology, 449 a.2d 900 (vt. 1982). 71. /d. at 901. 72. id. at 903. 73. id. at 314. 74. id. at 314-15. 75. phinney v. vinson, 605 a.2d 849 (vt. 1992). 76. /d. at 849. 77. pavlick. supra note 1, at 84 7. "[l]f apology does not appeal to reason and deals more with moral rather than legal roles, it is not surprising that it does not play a larger part in dispute resolution within a court-based legal system." id. 2008] apologies in the health care industry 351 dant' s extrajudicial statement, the majority of case law gives the impression that saying "i'm sorry" does not produce a prima facie case of medical malpractice. 2. effect of apologies in litigation even if the wrongdoer apologizes to the injured party and the apology is entered into evidence, studies indicate that jurors perceive those who show re­ morse more positively than those who do not. 78 in wardrip v. hart, the district court took into consideration the fact that the defendant physician "never apo­ logized to the plaintiff or demonstrated genuine remorse for his conduct" after injecting the plaintiff's foot with absolute alcohol. 79 the court imposed a puni­ tive damage award against the defendant in the amount of$200,000. 80 as such, apologies, or lack thereof, inevitably weigh on the minds of judges and juries during litigation. a defendant that apologizes to the injured party will likely invoke sympathy on behalfofthejudge andjury.81 "judges and juries under­ stand that expression of sympathy, regret, remorse and apology are not neces­ sarily admissions of responsibility or liability. ,,sz in the courtroom, the judge and jurors are also aware that the defendants in medical malpractice trials are more than just physicians;83 they are human beings capable of feeling regret and sympathy. c. scholarly studies 1. the robbennolt study jennifer k. robbennolt conducted a study entitled the "effects of apolo­ gies on settlement decisionmaking and factors influencing the effects of apologies."84 robbennolt's study investigated the effect of apologies on set­ tlement decision-making. in conducting this study, robbennolt considered three forms of communication: no apology, partial apology, and full apology. she defmed a partial apology as one in which the party "merely expressed sym­ pathy for the potential claimant's injuries," and a "full apology" as one in which the party "also took responsibility for causing the injuries.',ss in other 78. robbennolt, supra note 24, at 476. 79. see wardrip v. hart, 949 f.supp. 801, 805 (d. kan. 1996). 80. !d. 81. cohen, supra note 48, at 1022. 82. robbennolt, supra note 24, at 470. 83. rehm & beatty, supra note 6, at 121. "it appears that there is an understanding that the result of an operation is not guaranteed, not every operation will be successful, and an apol­ ogy for the inadequacy of an operation does not mean the doctor is liable for negligence." !d. 84. robbennolt, supra note 24, at 484-501. 85. !d. at 484. 352 indiana health law review [vol. 5:337 words, robbennolt differentiated between a simple expression of sympathy and a fault-admitting apology. the results ofthis study demonstrated that injured patients were more in­ clined to accept settlement offers when given a full apology, rather than a par­ tial apology or no apology at all.86 the responses indicate, however, that a partial apology was better than no apology at all. 87 this study furthers the as­ sertion that doctors who take it upon themselves to not only apologize to their patients in the wake of a medical error, but also accept responsibility for the error may suffer a lesser monetary and emotional detriment. 2. the vincent study in 1992, charles vincent and others conducted a study entitled "why do people sue doctors? a study ofpatients and relatives taking legal action."88 vincent's study demonstrates that families and patients who filed a medical malpractice lawsuit against a physician would not have done so if the physician had offered a full explanation and an apology.89 additionally, the study indi­ cated that the factors that were present weighed more heavily in favor of com­ municating about the issue rather than seeking mere monetary compensation.90 similar to the robbennolt study, this survey demonstrates that open communi­ cation that includes an expression of sympathy will likely reduce the physi­ cian's odds of ending up in the courtroom. 3. the gallagher study thomas gallagher's study utilized focus groups comprised of patients and physicians who discussed the proper way to handle a hypothetical medical er­ ror.91 gallagher's study demonstrated that patients wanted to be assured that their physician felt remorse and would make changes to prevent the error from 86. !d. at 485-86. the participants in the study each assumed the role of a patient who was injured as a result of a physician's medical error. each participant was given a settlement offer. when no apology was offered to the patient, fifty-two percent of respondents stated that they would "definitely or probably accept the offer," forty-three percent said they would "defi­ nitely or probably reject the offer," and five percent were unsure. when a partial apology was offered, thirty-five percent accepted the offer, twenty-five percent were inclined to reject the offer, and forty-percent were unsure. when a full apology was offered, seventy-three percent of the respondents were "inclined to accept the offer" and only thirteen to fourteen percent either rejected the offer or remained unsure. /d. 87. jd. at 480. 88. vincent & young, supra note 8, at 1612. 89. !d. at 1611. almost forty percent of respondents who filed a medical malpractice claim stated that the litigation would not have been necessary if the physician had explained the circumstances to the patient and family, as well as apologized. !d. 90. !d. at 1612. 91. thomas h. gallagher et al., patients' and physicians' attitudes regarding the disclo­ sure of medical errors, 289 jama 1001, 1001 (2003). 2008] apowgies in the health care industry 353 reoccurring.92 the study also revealed that the physicians wanted to apologize to their patients following an adverse outcome, but were concerned about the potential for legalliability.93 many physicians who participated in the study expressed the belief that if the patient desired more information or further communication, the patient would simply ask "follow-up" questions.94 the study demonstrates that there is a gap in the communication between the physi­ cian and the patient, which may lead to potential legal ramifications for the physician. patients indicated that "they would be less upset if the physician disclosed the error honestly and compassionately and apologized ... [and] ... that explanations of the error that were incomplete or evasive would increase their distress."95 gallagher's study suggests that if physicians strive to bridge the communication gap that typically arises after an adverse medical outcome, the patient will be more inclined to discuss the matter with the physician di­ rectly rather than with an attorney. d economic benefits to protecting apologie/6 1. preventing litigation apologies are likely to reduce the injured party's anger, thereby reducing the possibility of the party filing suit.97 studies demonstrate that the majority of patients who have been injured as a result of a medical error would not have pursued a lawsuit against the physician if the physician had apologized for the harm after it occurred. 98 many patients who have been injured as a result of medical malpractice simply want to ensure that the physician who allegedly caused the harm will not cause harm to other patients. "[a] recipient's interpretation of an apology as an indication that the behavior will not be repeated may predict willingness to set­ tle."99 accordingly, injured parties often feel that if the wrongdoer expresses sympathy and remorse for his or her actions, he or she is not likely to let the same harm take place in the future. 100 likewise, physicians who utilize open communication with their patients are likely to engage in open communication 92. ld. at 1004. 93. ld. 94. ld. at 1003-04. 95. ld. at 1005. 96. jonathan r. cohen, apology and organizations: exploring an example from medical practice, 27 fordhamurb. l.j. 1447, 1458 (2000). 97. cohen, supra note 48, at 1 022. 98. cohen, supra note 45, at 842. 99. robbennolt, supra note 24, at 479. 100. /d. at 478. 354 indiana health law review [vol. 5:337 with their risk managers and staff supervisors, increasing the potential for pre­ ventative action to be taken. 101 2. encouraging settlement discussions under some circumstances, serious settlement discussions cannot take place until a genuine expression of sympathy is offered to the injured party. 102 "indignity can be a large barrier to compromise, and in many cases, an apology is needed before other aspects of the dispute, such as monetary compensation, can be settled."103 an apology alone may not be a sufficient remedy for the injured party. "[a] statement of sympathy does not mend the wound nor re­ store a party to her pre-injured status."104 nevertheless, physicians who apolo­ gize for their errors begin the healing process for the injured party and enable the patient to look beyond anger and towards recovery. e. case studies 1. veterans affairs medical center in lexington, kentucky the state of kentucky does not currently have a law that protects expres­ sions of sympathy from being admitted as evidence. kentucky, however, has made its mark by the way one of its hospitals handles adverse medical out­ comes. the veterans affairs medical center in lexington (the "lexington va hospital") emphasizes the importance oftelling the truth. in 1987, the lexing­ ton va hospital initiated a revolutionary approach to handling medical er­ rors.105 the new approach required physicians to inform patients of any medical error that resulted in harm, even if the patient was unaware that the harm took place. 106 "[i]fthe lexington va's risk management committee de­ termined that the hospital was at fault, the hospital would offer an apology to the patient and family and admit fault both verbally and in writing. "107 in addi­ tion to disclosing the error and apologizing to the patient and his or her family, 101. cohen, supra note 96, at 1467. "[e]xtemal apology can prompt the disclosure and the investigation of errors that is needed for preventive measures." !d. 102. bartels, supra note 29, at 154. the author suggests that an expression of sympathy may "serve as a lubricant to advance settlement by softening the psychic injury that prevents the parties from agreeing on the amount of compensation." !d. 103. cohen, supra note 48, at 1020. 104. bartels, supra note 29, at 155; see also anushka asthana, try saying sorry, nhs doctors told, observer, sept. 18,2005 (suggesting that although litigation might be reduced as a result of protecting apologies, patients who deserve compensation for their injuries should get it). 105. cohen, supra note 96, at 1447. 106. id. at 1452. 1 07. davenport, supra note 11, at 86-87. 2008] apologies in the health care industry 355 the lexington va hospital actually offers direction on how to file a claim. 108 while this practice would presumably increase the amount of medical malprac­ tice litigation, the opposite has proven true. 109 the lexington va hospital adopted the error disclosure policy after suf­ fering two malpractice lawsuits in 1986, costing approximately $1.5 million in damage awards. since the inception of the program, the lexington va hospital "has reduced its claims payments from among the highest in the 178-hospital va system to one of the lowest."110 it is worth mentioning that as a veterans' hospital, the va is a governmental entity, and its liability is therefore governed under the federal tort claims act. 111 this is noteworthy because va hospitals enjoy protection from punitive damages, as well as distinct procedural rules, which may reduce the amount of liability exposure a va hospital has as com­ pared to a private hospital. 112 in comparison to other va hospitals across the nation, however, the lexington va hospital is in the top quarter for total claims payments and the top sixth for average payment per claim. 113 this first case study suggests that it is in the interest of both physicians and health care facili­ ties to adopt policies governing the procedures for dealing with medical error claims.114 2. physicians reimbursement fund the physician reimbursement fund, a professional liability insurance provider, has made a name for itself over the past thirty years by becoming the longest standing program with the "most comprehensive, least cautious, and most true to conflict resolution principles."115 this physician-operated carrier, based in san francisco, california, was developed in response to rising mal­ practice insurance rates. 116 the program encourages physicians to utilize their communication skills and natural problem-solving talents to respond to medical errors. 117 108. robert j. walling & shavvna s. ackerman, having to say you're sorry, contingencies, nov. & dec. 2006, at 46, available at http://www.contingencies.org/ nov­ dec06/trade.pdf (last visited mar. 31, 2008). 109. /d. in the past seventeen years, only three cases have gone to trial, and the average settlement costs $16,000, as opposed to the national va average of $98,000. 110. cohen, supra note 96, at 1449 (quoting andrea gerlin, accepting responsibility, philadelphia inquirer, sept. 14, 1999, at al8.). 111. cohen, supra note 96, at 1455. 112. /d. 113. /d. at 1457. 114. berkley rice, 10 ways to guarantee a lawsuit, med. econ., july 8, 2005, at 66, available at http:/ /www.memag.com/memag/medical+malpractice%3a +communication/! 0ways-to-guarantee-a-lawsuit/ articlestandardl article/detail/168737 (last visited mar. 20, 2008). 115. morrison, supra note 28, at 949. 116. /d. 117. /d. at 949-50. 356 indiana health law review [vol. 5:337 the underlying policy of the program is called "code green". 118 code green's primary goal is the patient's health and safety, as well as the mainte­ nance of the physician-patient relationship. 119 "physicians are asked to give a full apology, including admitting error if accurate, for everyone involved in the care; they are counseled that sincerity is much more important than particular language."120 these communications, however, do not automatically infer that the physician is liable or to blame for the error. 121 as a result of the program, the physician reimbursement fund pays less than $600 dollars on average for the early resolution of a case as opposed to the average cost of $19,541 to enter into the legal arena. 122 in addition to a decrease in pay-outs, the program has also been able to offer physicians practicing in high-risk specialties premiums that are considerably lower than market price. 123 3. how the copic insurance co. encourages physicians to apologize the co pic insurance company, established in denver, colorado, devel­ oped a new program that also encourages physicians to apologize for any medi­ cal errors. "the program focuses on teaching doctors to discuss medical errors, say 'i'm sorry' and figure out how to 'make the patient whole.' the goal is to keep patients happy with their doctors and avoid costly lawsuits."124 the pro­ gram places the duty on the physician to communicate about the error, whereas the carrier only speaks to the patient specifically about reimbursement. 125 this approach eliminates any potential insinuation that the physician's concern for the patient's health is influenced by the desire to avoid stuffing the patient's pockets. within four years of the co pic program's inception, 1325 physicians joined and 433 claims were adjudicated, with payouts ranging from $100 to $26,000. 126 in addition to coaching physicians in the wake of medical error, co pic also offers mandatory training for doctors on the discussion of medical errors, apologizing, and how to make the patient whole after an adverse out­ come. 127 co pic's policy serves as additional evidence that utilizing apologies 118. physicians reimbursement fund, inc., code green, http://www.prfrrg.com/ code_green.shtml [hereinafter physicians reimbursement fund] (last visited feb. 20, 2008). 119. !d. 120. morrison, supra note 28, at 950. 121. physicians reimbursement fund, supra note 118. 122. morrison, supra note 28, at 953. 123. i d. at 954. the fund says it can ofier specialists in obstetrics and gynecology, ortho­ pedic surgery, and general surgery insurance premiums that are forty percent less than market price. !d. 124. rachel brand, doctors taught to admit mistakes and apologize: copic seeks more disclosure, cut in malpractice lawsuits, rocky mountain news, mar. 10, 2004, at 3b. 125. morrison, supra note 28, at 949. 126. brand, supra note 124, at 3b. 127. walling & ackerman, supra note 108. 2008] apologies in tile health care industry 357 in a structured approach to handle medical error lessens the burden on the phy­ sician, the patient, and the insurance company. v. fault-admitting apologies vs. expressions of sympathy a. differences among the states one of the primary variations among the state laws protecting apologies is whether the protection includes apologies admitting fault. almost half of the states that afford protection to physicians who apologize do not protect admis­ sions of fault, even if the admission is subsumed within an expression of sym­ pathy. 128 "it is the power of an apology to resolve conflict that makes the exemption so attractive ... , and it is the powerful content of an apologythe admission of faultthat makes [others] so opposed to these laws."129 colo­ rado, connecticut, south carolina, and georgia are the only states that cur­ rently protect fault-admitting expressions of sympathy from being entered into evidence. 130 "while the intuition is that such apologies [not admitting fault] will not be as effective as more complete apologies that acknowledge responsi­ bility, partial apologies are thought by some to be better than failing to apolo­ gize at all."l3l it is imperative that physicians know what type of apologies their state laws protect, because the vast majority of "i'm sorry" legislation does not shield physicians who admit fault when apologizing. b. benefits of protecting fault-admitting apologies at about the same age children are taught to apologize when they have done something wrong, children are also taught that honesty is the best policy. intuition and ethics urge individuals to take full responsibility for their actions, regardless of the consequence. in spite ofleamed behavior, the imminent threat of a medical malpractice lawsuit may encourage health care providers to limit their disclosures of error to the patient. "[i]f the doctor really cares about hav­ ing a positive relationship with the patient, the best foundation is by revealing the whole truth. a doctor who wants to be fully forthcoming should be counted 128. see am. med. ass'n, advocacy res. ci'r., i'm sorry laws: summary of state laws (jan. 2007), http://www.ama-assn.org/ama/pub/category/7470.html (on file with the au­ thor); see infra app. 1. 129. cohen, supra note 43, at 866. 130. barton, supra note 56, at 848. the article does not include connecticut or south carolina as states that protect fault-admitting apologies because those laws were approved after the barton article was published; see also matt kempner, legislature '05: tort bill covers doc­ tors' words, too, atlantaj.&const., feb. 12,2005, at fl. 131. robbennolt, supra note 24, at 469. 358 indiana health law review [vol. 5:337 as morally praiseworthy .... "132 states with laws that protect fault-admitting apologies reward those who take responsibility for their actions. jonathan cohen, associate professor of law and associate director of the institute for dispute resolution at the university offlorida levin college of law, identifies four reasons for protecting fault-admitting expressions of sympathy. 133 the first is to encourage parties to settle and avoid the costly and time-consuming litigation. 134 second, fault-admitting apologies "promote natu­ ral, open and direct dialogue between people after injuries .... " 135 communi­ cation is an essential component of a good physician-patient relationship. in the aftermath of an unfavorable outcome, communication is essential to salvage that relationship. thirdly, apologies that admit fault "express the culmination of the logic already implicit in the evidence codes .... "136 in essence, fault­ admitting apologies are the equivalent of admitting one's guilt. under the fed­ eral rules of evidence, party-opponent admissions are admissible evidence. 137 thus, fault-admitting apologies not only express the physician's sympathy, but also express the physician's willingness to admit he or she committed error. the final and perhaps most important benefit of protecting fault-admitting apologies is the encouragement of individuals to engage in the "moral and hu­ mane act of apologizing after they have injured another. "138 in addition to the benefits outlined by cohen, fault-admitting apologies can also prevent future mistakes. "[a ]pologizing involves admitting mistakes, and when mistakes are more easily admitted future mistakes are more easily prevented."139 as such, fault-admitting apologies are beneficial to more than just the health care provider and the patient. hospitals can utilize the informa­ tion disclosed following medical error to prevent future occurrences. thus, disclosure of the mistake will likely improve both the efficiency of the hospital and the safety of future patients. finally, fault-admitting apologies benefit those who are directly involved in the adverse incident. "the patient may benefit from learning information about the specific medical error and from feeling that he is being dealt with ho­ nestly. the medical provider may benefit as well, finding a psycho-ethical re­ lease from the guilt attached to a concealed mistake."140 this sort of 132. cohen, supra note 48, at 1061. 133. cohen, supra note 43, at 841. 134. id. 135. id. 136. id. 137. fed. r. evid. 801(dx2). 138. cohen, supra note 43, at 841. 139. id. at 863; see also cohen, supra note 96, at 1465 (discussing the link between ex­ pressions of sympathy and the prevention of future errors). cohen states, "as an act of external honesty, openness and humility, apology can facilitate the same internally and thus promote change." id. 140. jonathan r. cohen, toward candor after medical error: the first apology law, 5 !iarv. healtiipol'yrev. 21,22 (2004). 2008] apologies in the health care industry 359 communication promotes an atmosphere in which physicians maintain their integrity and patients receive sincere responses to their questions and concerns. c. potential disadvantages of protecting fault-admitting apologies in protecting apologies that incorporate an admission of fault there is po­ tential for abuse. it is possible that wrongdoers will "issue apologies knowing that there's no real risk involved, but naive injured parties will think these apologies are meaningful . . . . [they] will think the injurers are putting their necks on the line when in fact they aren't."141 by preventing fault-admitting apologies from being entered into evidence, lawyers and legislators could po­ tentially be undermining a key aspect of an apology: admitting you are wrong and accepting the consequences. 142 no one likes to communicate unwelcome information, but if statutory pro­ tection minimizes penalties for doing so, the inclination to disclose one's fault increases. "when the performer of apology is protected from the consequences of the performance through carefully crafted statements and legislative direc­ tives, the moral thrust of apology is lost."143 where wrongdoers once felt com­ pelled by their conscience to offer apologies to those they harmed, they may now have ulterior motives for apologizing. apologies involve more than just words. a physician executive who par­ ticipated in the "patient trust and safety survey" conducted by the american college of physician executives remarked: the word 'apology' seems inappropriate unless the pro­ vider were to perceive negligence on his/her/its own part. to acknowledge that there has been an adverse event directly related to what was done or not done by the provider, genuine concern for the patient's ongoing welfare, and an effort to provide support and continuity of care is what is important. 'i'm sorry' is too easy, too dangerous, and meaningless unless associated with the above three components. 144 by protecting individuals from the consequences of admitting they did some­ thing wrong, states that enact legislation protecting fault-admitting apologies run the risk of eliminating the essence of a true apology. 141. cohen, supra note 4, at 856. 142. lee taft, apology subverted: the commodification of apology, 109 yale l.j. 1135, 1157 (2000). 143. /d. 144. lola butcher, lawyers say 'sorry' may sink you in court, physician executive, mar. & apr. 2006, at 20, 23. 360 indiana health law review [vol. 5:337 vi. the actual apology a. definition of"apology" the art of apologizing requires more than a simple declaration of "i'm sorry." given the varying styles of presenting an apology and the numerous ways an apology may be interpreted, attorneys advising their physician-clients "will have to first be precise about what constitutes expressions of sympathy and statements of fault, and second, properly determine the meaning behind the apology at issue."145 what one person considers an expression of sympathy, another person may consider an admission of fault. an "apology" is defined as "an admission of error or discourtesy accom­ panied by an expression of regret" (emphasis added). 146 this definition alone implies that the declarant of an apology is at fault, rather than merely express­ ing sympathy for the injured party. accordingly, some state statutes have left the word "apology'' out of statutory language, so as not to infer protection of an admission of fault. other states have utilized the word "apology," but added an additional provision specifying that fault-admitting apologies are considered admissible as evidence. 147 some states, however, have enacted legislation that protects "apologies" and yet does not address the admissibility of fault­ admitting apologies. 148 these examples highlight that the definition of"apol­ ogy" combined with the lack of specificity in certain state laws could poten­ tially lead to legislative misinterpretation and confusion. as such, attorneys and physicians should take great care when interpreting and applying the pro­ tections afforded by their applicable state law. there are three possible elements to an apology: "(i) admitting one's fault, (ii) expressing regret for the injurious action, and (iii) expressing sympathy for the other's injury."149 the presence of any one of these elements, in particular the first, may result in the statement being admitted into evidence, depending on the language of the relevant state statute. therefore, both physicians and their attorneys must know which elements of an apology are protected and which are not. b. presentation of an apology an expression of sympathy that is given by the injuring party out ofhis or her own free will is likely to produce a better outcome. "[i]n general, the more 145. bartels, supra note 29, at 149-50; see also rehm & beatty, supra note 6, at 117. 146. merriam-webster online dictionary, http://www.merriam-webster.com/ dictionary/apology (definition of apology) (last visited mar. 20, 2008). 147. seein.fraapp.l. 148. see infra. app. 1. 149. cohen, supra note 48, at 1014-15. 2008] apologies in the health care industry 361 an apology is coerced, the less meaning it carries, for the less sincere is the re­ gret it expresses."150 given the delicate nature of an injured victim following his or her injury, it is important that the communication between the injurer and injured be honest and devoid of ulterior motives. therefore, in preparing to discuss an adverse medical outcome with a patient, physicians should consider the "who, what, and when" of apologizing prior to making the communication. 1. who should give the apology? an injured party may accept an apology as being more sincere if it comes from the party who caused the harm.151 if possible, "[t]he doctor who treated the patientnot a staff person should explain the rationale for his diagnosis and treatment, why complications may have occurred, and how he'll manage them. " 152 if the communications come directly from the wrongdoer, the patient is more likely to feel that the wrongdoer acknowledges the error, prioritizes the importance of communicating with the patient, and expresses sympathy for the patient. 2. what can and cannot be said? syntax can determine whether the physician's words were simply an ex­ pression of sympathy or instead an admission of fault. there is a difference between saying "i am sorry that you are hurt," and "i am sorry that i hurt you. "153 patients may interpret a physician's expression of sympathy as an ad­ mission of fault, resulting in later complications during settlement negotiations and/or litigation.154 therefore, certain words such as, "mistake," "error," or "accident" should be avoided.155 there are four parts to a good apology: "an acknowledgment of the mis­ take or wrongdoing, the acceptance of responsibility, an expression of regret, and a promise that the offense will not be repeated."156 it should be noted that an admission of fault is not considered one of the primary components of an apology. this is because there is a distinction between acknowledging a mis­ take and admitting fault for the mistake. 150. /d. at 1018. 151. /d. at 1051. 152. rice, supra note 114, at 66. 153. davenport, supra note 11, at 99. 154. prager, supra note 49. the article quotes ron neupauer, vice president ofmedical underwriters of california, who states, "the problem many doctors have is finding the distinc­ tion between expressing sorrow and admitting fault." /d. 155. rice, supra note 114, at 66. 156. barbara kellerman, when should a leader apologize and when not?, harv. bus. rev., apr. 2006, at 72, available at 2006 wlnr 6089299 (asserting that "a less-than-perfect apology is often better than no apology at all."). 362 indiana health law review [vol. 5:337 3. when should the apology be given? the sooner the apology is given, the more likely the injuring party will avoid a conflict. "an early apology may prevent an injury from turning into a dispute, nipping possible conflict in the bud. "157 in order to smooth the way for future conversations, many experts agree that the sooner an apology is given, the better. 158 some professional liability insurance providers, however, encour­ age the physician not to apologize until he or she knows that an error actually occurred. the doctor's company, a medical malpractice insurance provider, suggests that physicians should take a moment to assess the incident before in­ stinctively offering an apology. 159 while the empathetic concern and emotional support expressed during this meeting [with the patient] require sensitivity, an apology is usually not appropriate at this time unless the investigation of the event has been completed and shows that a clear-cut error has occurred and could have been prevented, and that the person mak­ ing the apology was responsible. 160 although the doctor's company encourages full disclosure of adverse events along with a genuine expression of sympathy and even an apology if necessary,161 it also wants to ensure that their physicians are not inadvertently exposing themselves to liability by offering apologies in absence of error. gerald b. hickson, m.d., vice chair ofpediatrics at vanderbilt univer­ sity, has spent over fifteen years studying the reasons why doctors get sued. 162 hickson's study indicated that one of the reasons doctors get sued is a result of "deteriorating relationships."163 in order to preserve the physician-patient rela­ tionship, timely communication is essential. 164 "[f]ull disclosure of an adverse event at 5 a.m. may not be understood or explained well, but waiting may create distrust if the patient and his or her family learn later that not all the information 157. cohen, supra note 48, at 1049. 158. reni gertner, the art of apologizing takes hold in the legal world, daily record, dec. 22, 2005, available at 2005 wlnr 22036598 (ashley mccown, executive vice president of the public relations finn solomon mccown emphasizes the importance of quick apologies, but warns physicians that "[y]ou never want to say something when you're not absolutely sure about the facts."). 159. david b. troxel, physician disclosure of adverse events, the doctor's advocate, second quarter 2006, at i, 6. 160. id. 161. id. 162. robeznieks, supra note 50. 163. id. 164. see 735 ill. comp. stat. ann. 5/8-1901 (west 2007). illinois law only protects ex­ pressions of sympathy or explanation "within 72 hours of when the provider knew or should have known ofthe potential cause of such outcome." id. 2008] apologies in the health care industry 363 was given when it was first known."165 while it seems there is never a good time to disclose unpleasant news, the sooner an injured party receives commu­ nication regarding the adverse event, the less likely the issue will give rise to a lawsuit. 166 4. advising how to apologize with the increasing presence of"i'm sorry" laws, some practitioners and activist groups have started to develop strategies on how to communicate an effective apology. for example, in scotland, the scottish public services om­ budsman's office is currently drafting a seven-point advice list to serve as a guideline when offering apologies, detailing what an injured party expects when resolving a complaint. 167 sherry k water, director of quality and perform­ ance improvement at st. francis medical center in peoria, illinois, believes that physicians should rehearse what they plan to say to their patients and should avoid words that suggest blame, such as "mishap."168 the problem with these strategies and guidelines is that they may begin to depreciate the true value of the apology. "[a] sincere apology that is delivered too cavalierly or given after months oflegal posturing, may be perceived to be insincere and could actually increase tension between the parties."169 a scripted apology may engender more anger on behalf ofthe injured party than had there been no communica­ tion between the two parties at all.170 physicians first have to become comfort­ able with the concept of apologizing in the wake of a medical error, and then try to apply it in the proper context. given the traditional disfavor of utilizing apologies in the health care field, physicians will need guidance before imple­ mentation. c. sincerity and ulterior motives safeguarding apologies through state laws and judicial protections may affect the way in which apologies are viewed. if a patient is aware that apolo­ gies are offered without the potential for consequence, then he or she may be less likely to view the apology as serving its purpose. by barring apologies 165. robeznieks, supra note 50. 166. andis robeznieks, the power of an apology: patients appreciate open communica­ tion, amnews, july 28, 2003, http://www.ama-assn.org/amednews/2003/07/28/prsa0728.htm (last visited mar. 31, 2008) (according to ilene corina, president of persons united limiting substandards and errors in health care, "patients will keep looking until their questions are answered .... if all the doors are closed to them. they will go to lawyers.") (last visited mar. 20, 2008). 167. damien henderson, public services are given guidelines on how to say sorry, herald (glasgow, scot.), sept. 27,2006, at 6. 168. robeznieks, supra note 166. 169. bartels, supra note 29, at 150; see also cohen, supra note 48, at 1051 ("a natural expression will sound sincere, but staged sycophancy will ring empty."). 170. robeznieks, supra note 166. 364 indiana health law review [vol. 5:337 from entry as admissible evidence, a wrongdoer might apologize for the wrong reasons. it might "cheapen the meaning of an apology," because the wrongdoer knows he has nothing to lose by apologizing. 171 some scholars suggest that only full, unprotected apologies serve the moral and ethical purpose of an apol­ ogy. 172 in this respect, the argument is that without the potential for conse­ quences arising from an apology, "we risk subverting its moral dimension."173 without the moral dimension, an apology may be seen as nothing more than a "get out of the courtroom free" card.174 additionally, physicians who utilize apologies as a means to manipulate the injured party may engender hostility between the parties, rather than easing the conflict by offering a genuine ex­ pression of sympathy.175 vii. is saying "i'm sorry" enough? a. where 's the proof? the effect of utilizing apologies in the wake of a medical error is hard to quantify, given the difficulty in tracking medical malpractice settlements and other forms of alternative dispute resolution. "[t]here is a growing body of empirical evidence that apologies can have important effects on a variety of judgments that may underlie legal-settlement decisions. there has been very little systematic investigation, however, of the particular effects of apologies on legal-settlement decisionmaking."176 as such, the desire for more states to "leg­ islate morality" may not be very intense, given the nominal proof that protect­ ing apologies will have any effect on medical malpractice claims. 177 additionally, those states that currently have "i'm sorry" laws in effect do not necessarily enjoy a state of medical malpractice tranquility.178 case law and case studies suggest, however, that apologies do not render guilty verdicts and may actually prevent the physician from having to set foot in a courtroom in the first place. 171. cohen, supra note 43, at 847. 172. lee taft, apology within a moral dialectic: a reply to professor robbennolt, 103 mich. l. rev. 1010, 1013 (2005). 173. /d. 174. eisenberg, supra note 23, at 50 (noting that many critics feel that"[ a]pology laws ... could just usher in an epidemic of playacting."). 175. bartels, supra note 29, at 154. 176. robbennolt, supra note 24, at 480. 177. prager, supra note 49 (quoting paul r. barach, m.d., a safety researcher and profes­ sor of intensive care and cardiac anesthesia at the university of chicago, who was skeptical about the necessity of"i'm sorry" laws and believes that states can't "legislate morality."). 178. see mass. gen. laws ann. ch. 233, § 23d (west 2007); am. med. ass'n, supra note 7 (considering that massachusetts, which has protected the use of apologies in the health care context for over twenty years, is still in a state of medical malpractice crises). 2008] apologies in the health care industry 365 b. potential for problems 1. explanations of error as described above, the use of apologies in the medical arena generally can't take place unless the physician acknowledges that a medical error oc­ curred. accordingly, the suggestion that apologizing for medical errors will reduce litigation and encourage stronger physician-patient relationships is built on the assumption that physicians will also discuss the circumstances of the error with patients. disclosure may be contrary to the physician or hospital's standard practice. thus, utilizing apologies may implicate broader changes in the way in which medical error is handled. in order to achieve such a change in culture, hospitals must work as a sys­ tem to remove the stigma of failure that is currently placed upon physicians when errors are revealed. exemplifying such change in action, "some medical schools, including vanderbilt university school of medicine in nashville, [tennessee,] [provide] courses in communicating errors and apologizing [that] are now mandatory for medical students and residents."179 medical school curriculums may be the first place in which such changes should be made. the earlier a physician accepts the benefits of disclosure and apologies, the sooner the medical field will be able to reap the benefits of such tools. 2. whose advice should the doctor take? sometimes it is not clear whether a physician should apologize or not, given the varied instructions he or she has received from different entities. 180 as such, it is essential that physicians contact the appropriate people and enti­ ties prior to offering apology. even prior to the occurrence of a medical error, physicians should be proactive and contact entities such as their risk manager, legal counsel, or insurance carrier for guidance. 181 in this respect, physicians should not only engage in open communications with their patients, but they should also practice open communication with those people and entities that may have specific procedures in place for handling medical errors. it is likely that the risk managers, health care attorneys, professional liability insurers, and the individual physician will have opposing interests and thoughts regarding the i 79. davenport, supra note i i, at 91 (quoting rachel zimmerman, doctors' new tool to fight lawsuits: saying 'i'm sorry': malpractice insurers find owning up to errors soothes patient anger 'the risks are extraordinary, wall st. j., may i 8, 2004, at ai). i 80. butcher, supra note 144, at 20. 181. staci kusterbeck, sitting down to talk can keep patients from suing, ed legal letter, sept. 1, 2006. 366 indiana health law review [vol. 5:337 approach to apologies.182 if the recommendations and guidance of the varying entities are not in agreement, the physician should take it upon him or herself to consider the risks and benefits of each approach, along with any applicable state law, and try to strike a balance. vill. conclusion it is difficult to determine whether state legislation that protects expres­ sions of sympathy and/or admissions of fault will definitively mend the current state of medical malpractice liability crisis. a medical error and the subsequent communications between the physician and the patient is an extremely fact sen­ sitive situation. the effect of an apology will likely depend on the state in which the error took place, the specific content of the physician's communica­ tion, the severity of the harm, the history of the physician-patient relationship, and countless other factors. there will inevitably be patients that will settle for nothing less than a lawsuit. regardless, instinct and morality encourage us to apologize nonetheless. additionally, scholarly studies, case law, and case stud­ ies suggest that apologetic communications lend themselves to be advantageous in the wake of medical error. as with any implementation of new procedures, physicians will have to adapt to the changed practice and suppress the innate fear of litigation. physicians must accept that apologies can benefit both them­ selves and their patients. only when this occurs will the advantageous effects of apologies within the health care arena truly be realized. appendix 1: summary of state "i'm sorry" laws183 state law date of medical protection use of the approval specific of fault word "apology"184 ala. none alaska none ariz. ariz. apr. 25, yes does not yes rev. 2005 mention stat. ann.§ 12-2605 182. butcher, supra note 144, at 20, 23 (quoting a physician executive who participated in acpe's patient trust and safety survey who stated: "there are disconnects in my organization among the corpomte level, the local hospitals and the medical staffs on whether or not it is ap­ propriate to make an apology ... most physicians are very uncomfortable about making an apology because they have been instructed by their malpmctice carriers not to do this."). 183. last updated oct. 25,2007. 184. whether or not the language of the state law specifically uses, and thereby protects, the term "apology" or any form of the word "apology." 2008] apologies in the health care industry 367 ark. none cal. cal. june 30, no no no gov. 2002 code§ 11440.45 colo. colo. apr. 17, yes yes yes rev. 2003 stat. ann.§ 13-25135 conn. conn. july 13, yes yes yes gen. 2005 stat. § 52-184d del. del. july 10, yes no yes code 2006 ann. tit. 10 § 4318 fla. fla. june 1, no no no stat. 2001 ann.§ 90.4026 ga. ga. code feb. 16, no1ss yes yes ann.§ 2005 24-3-37.1 haw. haw. feb. 27, yes no no rev. 2006 stat.§ 626-1, rule 409.5 idaho idaho july i, yes no yes code 2006 ann.§ 9207 185. while the law protects expressions of sympathy used outside of the health care con­ text, the law states that "conduct, statements, or activity should be particularly encouraged be­ tween health care providers and patients experiencing an unanticipated outcome resulting from their medical care." 368 indiana health law review [vol. 5:337 ill. 735 ill. aug. 25, yes does not yes comp. 2005 mention stat. 5/8-1901 ind. ind. mar. 17, no no yes code§ 2006 34-43.51-4 iowa iowa may24, yes does not no code§ 2006 mention 622.31 kan. none ky. none la. la. rev. june 16, yes no yes stat. 2005 ann.§ 13:3715. 5 me. me. rev. june 10, yes no yes stat. 2005 ann. tit. 24,§ 2907 md. md jan. 11, yes no yes code 2005 ann., cts. & jud. proc. § 10-920 mass. mass. dec. 24, no does not no gen. 1986 mention lawsch. 233 § 23d mich. none minn. none miss. none mo. mo. ann. mar. 29, yes no no stat.§ 2005 538.229 mont. mont. july i, yes does not yes code 2005 mention ann.§ 26-1-814 2008] apologies in the health care industry 369 neb. none nev. none n.h. n.h. june 17, yes no no rev. 2005 stat. ann.§ 507-e:4 n.j. none n.m. none n.y. none n.c. n.c. aug.2, yes does not yes gen. 2004 mention stat. ann.§ 8c-l, rule 413 n.d. none ohio ohio rev sept. 13, yes does not yes code 2004 mention ann.§ 2317.43 okla. okla. may28, yes does not yes stat. tit. 2004 mention 63, § 11708.1h or. or. rev. june 16, yes does not yes stat. 2003 mention ann. § 677.082 pa. none r.i. none s.c. s.c. june9, yests6 yes yes code 2006 ann.§ 19-1-190 s.d. s.d. feb. 18, yes no yes codified 2005 laws§ 19-12-14 186. language used here similar to that used in georgia's statute. 370 indiana health law review [vol. 5:337 tenn. ten. july i, no no no rules of 2003 evid., rule 409.1 tex. tex.cn. june 18, no no no prac.& 1999 rem. code ann.§ 18.061 utah utah mar. 1, yes does not yes code 2006 mention ann.§ 78-14-18 vt. vt. stat. 2nd legis. yes does not yes ann. tit. session, mention 12, § 2005 1912 va. va. code mar. 23, yes no no ann.§ 2005 8.01-52.1 wash. wash. apr. 3, no no no rev. 2002 code ann.§ 5.66.010 w.va. w.va. may4, yes does not yes code 2005 mention at.'n. § 55-7-lla wis. none wyo. wyo. july 17, yes does not yes stat. ann. 2004 mention § 1-1-130 working the system: should patients in need of an organ transplant be able to join multiple w aitlists? chad j. wilson· i. introduction ............................................................................... 230 a. the issue ................................................................................... 231 b. roadmap ................................................................................... 233 ll. the history and functioning of tile organ transplant system in the united states ..................................................... 233 a. history ....................................................................................... 234 b. cu"ent structure and functioning of the organ transplantation process ............................................................ 238 1. the relationship between transplant centers and organ procurement organizations ..................................... 238 2. unos policy for organ allocation .................................... 239 3. not all organ procurement organizations are created equal ...................................................................... 242 4. not all transplant centers are created equal .................. 243 5. unos allows multiple listings .......................................... 245 ill. patients in need of an organ transplant should continue to be allowed to place themselves on the wait list at multiple transplant centers .......................... 246 a. arguments in favor of allowing patients to place themselves on multiple waitlists .............................................. 246 1. patient autonomy in treatment choices ............................ 246 2. multiple wait listing may potentially help patients who are only on a single list ............................................. 249 3. economic argument ............................................................ 250 4. enforcing wait time equity frustrates the two goals of hhs in relation to organ transplantation ..................... 251 a. minimal waste of organs .............................................. 251 b. maximum survival rates ............................................... 252 b. arguments for disallowing patients to place themselves on multiple waitlists ................................................................. 254 1. public view of the fairness of the system affects the likelihood of donation ...................................................... 254 2. allowing multiple listings "pushes" a truly local patient down the list further and forces him to wait • j.d. candidate, 2011, indiana university school of lawindianapolis; doctor of physical therapy, 2005, indiana university school of medicine; b.a., 2002, indiana uni­ versity. 230 indiana health law review [vol. 8:229 longer .................................................................................. 255 iv. conclusion .................................................................................. 256 i. in1roduction in october of 2003, steve jobs, the cofounder and ceo of the well­ known computer and technology company apple, 1 underwent a routine ab­ dominal scan.2 during this scan, doctors found an abdominal tumor;3 a bi­ opsy of the tumor revealed that jobs had pancreatic cancer.4 while pancreatic cancer is very often a death sentence,5 jobs was lucky. doctors found that he had a rare, more treatable form and that successful surgical removal of the tumor would most likely lead to at least ten more years of life.6 after going against his doctors' orders by pursuing alternative treat­ ments for nine months, jobs underwent surgery to remove the tumor from his pancreas in july 2004 at stanford university medical center in palo alto, califomia.7 a few years following his surgery, jobs had complica­ tions and needed a liver transplant. 8 he underwent this procedure in april of 2009.9 the fact that a well-known businessman or celebrity received a liver transplant is not noteworthy in itself. in this case, however, jobs' transplant surgery took place at a hospital located in tennessee, approxi­ mately 2,000 miles from his home in northern california.10 media coverage often undermines the american public's trust in the organ transplant system.11 the american public often assumes that celebri­ ties or other well-known people get preferential treatment when waiting for an organ transplant.12 in 1995, professional baseball legend mickey mantle received a liver transplant only forty-eight hours after being placed on the 1. ray hainer, did steve jobs' money buy him a faster liver transplant?, cnn healtii (june 24, 2009), http://www.cnn.com/2009/health/06/24/ liver.transplant .priority.listslindex.html. 2. peter elkind, the trouble with steve jobs, cnn money (mar. 5, 2008), http:l/money.cnn.com/2008/03/02/news/companies/elkind_jobs.fortune/'mdex.htm. 3. /d 4. id 5. pancreatic cancer life expectancy, pancreatic cancer treatment, http://www.pancreaticcancertreatment.net/pancreatic-cancer-life-expectancy.html (last visit­ ed mar. 6, 2010). 6. elkind, supra note 2. 7. id 8. hainer, supra note 1. 9. id. while the controversy surrounds jobs' liver transplant, his previous health concerns with pancreatic cancer are pertinent background information because concurrent or past illnesses are a consideration in determining organ allocation. 10. /d. 11. gail l. daubert, notes & comment, politics, policies, and problems with organ transplantation: government regulation needed to ration organs equitably, 50 admin. l. rev. 459,477-78 (1998). 12. hainer, supra note 1. 2011] working the system 231 waitlistp mantle then died two months later!4 in mantle's case, media attention was great, and the public, along with numerous medical ethicists, debated whether he should have even received the transplant. 15 cases such as this one may lead the public to view the organ transplant system as unfair and inequitable. this may lead to a decrease in the number of people who are willing to donate their organs for transplantation to a system that is al­ ready short on donors.16 media coverage of steve jobs' liver transplant may have the same effect on potential donors. in the current system, patients with better resources and a better un­ derstanding of how the system functions may be able to use this infor­ mation to improve their likelihood of receiving an organ transplant.17 the median wait time for a liver between 2002 and 2007 varied widely between various organ procurement organizations (opos); the national average was just over one year, 18 while some opos wait time was as high as three years.19 however, the opo from which steve jobs received his liver for transplant had a median wait of just over four months,20 while the median wait time before liver transplant for patients between july 1, 2003 and de­ cember 31, 2008 at the university of california at los angeles medical center (a hospital performing liver transplants in jobs' home state of cali­ fornia) was 25.6 months.21 a. thelssue while some might assume that jobs received preferential treatment due to his financial and celebrity status, it is more likely that he placed him­ self on the waiting lists at multiple transplant centers.22 the united net­ work for organ sharing (''unos") conducts periodic audits of transplant centers to ensure that candidates are not given preferential treatment over others on the list for nonmedical reasons.23 some patients receive an organ 13. daubert, supra note 11, at 478; see also hainer, supra note 1. 14. daubert, supra note 11, at 478. 15. id. 16. id.; see also david orentlicher, mary anne bobinski & mark a hall, bioetincs and pmmc healm law 405 {2nd ed. 2008). 17. hainer, supra note l. 18. id.; see also national report for selected organ, liver, table 6: time to trans­ plant for waitlist patient, scientific reois1ry of transplant recipients ("srtr"), http://www.ustransplant.org/csr/current/nationalviewer.aspx?o=li&t=06 (last updated july 13, 2010) (stating that the national median time to liver transplant between july 1, 2004 and june 30,2009 was 10.9 months, based on data available as ofmarch 30, 2010). 19. hainer, supra note 1. 20. id. 21. srtr, program and organ procurement organization specific reports: university of california at los angeles medical center, liver 13 (2009), available at http://www.ustransplant.org/csr/archives/200906/cauctx1li200906.pdf. 22. hainer, supra note 1. 23. id. 232 indiana health law review [vol. 8:229 for transplantation more quickly than others do because they are "standing in more lines" by placing themselves on the waiting list at multiple trans­ plant centers.24 unos is fully aware of this practice and expressly allows patients to list themselves at multiple transplant centers.25 further, unos allows these listings to be performed at centers located in different geo­ graphical locations that are served by different opos.26 this rule allows a patient like steve jobs to potentially decrease the time they spend waiting to get a transplant. many patients, however, are unable to be listed at multiple transplant centers due to cost.27 in fact, many patients cannot afford the costs associ­ ated with transplantation when listed at just a single transplant center?8 the current estimated cost of a liver transplant is $519,600.29 this cost prohib­ its approximately one-third of americans from obtaining the transplant they need due to insufficient insurance, or a total lack thereof.30 nevertheless, while many patients are hindered by the financial requirements of transplan­ tation, those with large financial assets, like jobs, are able to use the assets to their advantage. to be evaluated at multiple centers, one must have the financial and physical resources to travel around the country.31 the mone­ tary requirement includes the ability to pay all the costs associated with multiple evaluations, as many insurance plans do not cover the cost of ex­ amination and evaluation at more than one transplant center.32 further, one must have the financial means to travel to any transplant center across the country at a moment's notice when the needed organ becomes available. lastly, at some transplant centers the ability to pay for a transplant is a pre­ requisite to being placed on the wait list.33 because steve jobs' estimated worth is approximately twenty-two billion dollars, 34 the financial and travel issues were not constraining factors, allowing him to take advantage of the fact that unos does not prohibit patients from listing themselves on multi­ ple waiting lists around the country.35 most likely, because of this practice, 24. ld 25. unos, 3.2: organ distribution, unos patient waiting list, health res. & serv. admin., http://optn.transplanthrsa.gov/policiesandbylaws2/policies/pdfs/policy_ 4.pdf (last updated nov. 9, 2010) [hereinafter unos 3.2] ("candidates may be waitlisted at multi­ ple transplant centers. these transplant centers may be located within the same opo service area. these transplant centers may be located within different opo service areas."). 26. ld. 27. john a. sten, comment, rethinking the national organ transplant program: when push comes to shove, 11 j. contemp. healtii l. & pol'y 197, 200 (1994) (noting patients who cannot pay for surgery are not listed). 28. hainer, supra note 1. 29. id. 30. id. 31. id. 32. id. 33. id 34. elkind, supra note 2. 35. unos 3.2, supra note 25. 2011] working the system 233 steve jobs received a liver transplant in a very short amount of time at a transplant center halfway across the country from his home. while the ini­ tial, instinctive reaction is to condemn jobs as unfairly "pushing" his way to the front of the line, the fact of the matter is that he simply followed the ex­ press conditions and guidelines of the unos policy that allow transplant patients to list themselves at multiple transplant centers.36 presumably, jobs did what any other person with sufficient financial and physical means would have done. nonetheless, the heart of the issue centers on the ques­ tion of whether this "multiple lists" policy allows the wealthy a better, yet unfair, opportunity to receive an organ transplant. further, even if the cur­ rent system does allow an advantage to the wealthy, are there sufficient rea­ sons to maintain the status quo? b. roadmap this note discusses the practice of patients in need of organ trans­ plants placing themselves on waitlists at multiple transplant centers located around the country. to facilitate understanding of this practice, section ii describes the history of the organ transplant system in the united states, including a discussion of the reasons for implementation of current laws. section it also includes a description of the current structure and function­ ing of the organ transplantation process by discussing the relationship be­ tween organ transplant centers and organ procurement organizations, and by giving a detailed explanation of unos policies that regulate organ alloca­ tion. finally, this section highlights differences in the way that various or­ gan procurement organizations function in distinct areas of the united states. section iii analyzes arguments for maintaining the status quo and for disallowing multiple wait listing. finally, the note concludes that cur. rent unos policies allowing patients to list themselves at multiple trans­ plant centers is the best option. ii. the history and functioning of the organ transplant system in the united states in order to determine whether listings at multiple centers should be al­ lowed by transplant seeking patients, a full understanding of the history and functioning of the organ transplant system in the united states is neces­ sary. this section explains the general history of the transplant system and describes legislation regarding the current functioning of the organ trans­ plant process, including a discussion of the differences that occur in various geographical locations across the country. 36. ld. 234 indiana health law review [vol. 8:229 a. history researchers began experimenting with the science of organ transplan­ tation in animals and humans in the eighteenth century.37 the first success­ ful human kidney transplant was performed in 1954 and the first successful human liver transplant followed in 1967.38 nowadays, transplantation of kidneys, hearts, livers, lungs, pancreases, intestines, and other organs has become routine medical procedure. 39 during the initial development years of human organ transplant science in the 1950's and 1960's, the decisions, procedures, and policies concerniil.g procurement. and allocation of human organs were controlled and made by the medical community40 because there were no transplant-specific state or federal laws that governed the process.41 as the science of transplantation progressed, 42 transplant departments at hospitals formed organizations to collect organs from donors.43 these organ procurement organizations ("opos'') were also responsible for dis­ tributing donated organs to patients in need.44 without centralized regula­ tion, opos developed in different ways with significant variation among the different organizations. 45 these variations include differences in the number of organs procured, the number of transplants performed at the transplant hospital where the organs are allocated, and the average and me­ dian time patients spend on the waitlist until a transplantable organ is found.46 further, there were many private transplantation networks serving specific self-determined regions that all functioned independently of one another.47 as a result, there were numerous geographical gaps and overlaps in the organ transplant system. 48 in fact, transplant hospitals in some areas of the united states would actually compete with other hospitals to get do­ nor organs for transplant, while in other regions there were no transplant 37. organ procurement and transplantation network, history, health res. & serv. admin., http://optn.transplant.hrsa.gov/about/transplantationlhistmy.asp (last visited sep. 15, 2010). 38. jd. 39. jd 40. eric f. galen, note, organ transplantation at the millennium: regulatory framework, allocation prerogatives, and political interests, 9 s. cal. lnterdisc. l. j. 335, 336-37 (1999). 41. id. at 337. 42. s. rep. no. 98-382, at 2 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975, 3976 (providing background and need for legislation based on advances in the science of human organ transplantation). 43. id. at 2-4 (discussing the number of opos in existence at the time); see 42 u.s.c.a. § 273 (west 2003) (providing legal requirements for an organ procurement organi­ zation). 44. see 42 u.s.c.a. § 273(bx3) (west2003). 45. galen, supra note 40, at 337. 46. jd. 47. s. rep. no. 98-382, at 2-4 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975, 3978. 48. daubert, supra note ll, at 462. 2011] working tile system 235 centers at al1.49 because of the difficulties presented by the lack of regulation, legisla­ tors began enacting state laws addressing organ donation in the 1960s. 50 federal legislation followed, enacted in the 1980s.51 the main purpose of the federal legislation was to intervene in the organ allocation process.52 at this time the federal government acknowledged the progress in the science of human organ transplantation and changed the characterization of heart and liver transplants from "experimental" to "medically appropriate. "53 because of this change transplant procedures were eligible for coverage under medicare, medicaid, and private third-party insurance, making the procedures accessible to more americans in need. 54 prompted by the rublic's concern about the difficulties of obtaining an organ for transplant,5 as well as medico-ethical issues arising in organ transplantation, congress enacted the national organ transplantation act of 1984 (''nota"). 56 as transplantation became increasingly common, the practice of buying and selling organs through organ brokers became more popular. 57 congress felt that the buying and selling of human organs for transplant was against society's ethical and moral values and called the pro­ cess "supply-side cannibalism. "58 congress was also fearful that allowing such a system would make the "poor a source of spare parts for the rich. "59 as a result, this federal statute expressly prohibited the commodification of human organs for transplantation.60 the statute makes it ''unlawful for any person to knowingly acquire, receive, or otherwise transfer any human or­ gan for valuable consid.eration.'761 violation of this statute may lead to ei­ ther imprisonment not greater than five years or fines no greater than $50,000, or both.62 the term "valuable consideration" does not include 49. id. 50. galen, supra note 40, at 337. 51. national organ transplant act, pub. l. no. 98-507,98 stat 2339 (1984) (codified as amended at 42 u.s.c. § 273-74 (2006)). 52. s. rep. no. 98-382, at 1-4 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975-78. 53. ld at 2-3; see also galen, supra note 40, at 337. 54. galen, supra note 40, at 338. 55. s. rep. no. 98-382, at 3 (1984), reprinted in 1984 u.s.c.c.a.n. 3,977. 56. 98 stat 2339. see generally 42 u.s.c.a. § 273-4 (west 2003). 51. s. rep. no. 98-382, at 2-4, 16-17 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975, 3978, 3,982, 39,83 (showing concern for prohibiting the buying and selling of human or­ gans). 58. procurement & allocation of human organs for transplantation, 1983: before the subcomm. on investigation & oversight of the house comm. on science & tech, 98th cong. 248 (1983) [hereinafter hearings]; see also daubert, supra note 11, at 466. 59. hearings, supra note 58, at218; see also daubert, supra note 11, at466. 60. 42 u.s.c. § 274e (2006). 61. id. 62. id. 236 indiana health law review the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.63 [vol. 8:229 congress had three major goals in passing not a. it aimed to articu­ late a national health policy for. organ transplantation, to ensure equitable allocation of donor organs, and to increase the number of organs available for transplantation. 64 in order to help achieve these goals, congress created the task force on organ transplantation, which recommended a system for equitable organ allocation.65 the most significant aspect of this system was the establishment of the organ procurement and transplantation network ("optn'').66 medical professionals of the transplant community operate the optn. such operation allows medical judgment to remain paramount while assisting opos to ensure equitable allocation of organs on a nation­ wide basis.67 under nota, the optn is required to: 1) maintain a national organ waiting list of organ transplant candidates; 2) match cadaveric organs with the patients on the waiting list; 3) establish policies concerning organ allocation; 4) set quality standards for acquisition and transplan­ tation of organs; 5) coordinate transportation of organs from opos to transplant hospitals; 6) analyze and publish data concerning transplanta­ tion; and 7) report comparative costs and outcomes concern63. 42 u.s.c. § 274e (c)(2) (2006). 64. s. rep. no. 98-382, at 1-4 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975-78; see also organ procurement and transplantation network, 63 fed. reg. 16,296, 16,297 (apr. 2, 1998) (to be codified at42c.f.r. part 121). seegenerally42 u.s.c.a § 274 (west2003). 65. s. rep. no. 98-382, at 1-2 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975-76; see also daubert, supra note ii, at 464. 66. 42 u.s. c. § 274 (2006). 67. 42 u.s.c.a. § 274(b)(2) (west 2003); see also organ procurement and transplan­ tation network. 63 fed. reg. i6,296, i6,300 (apr. 2, 1998) (the u.s. department of health and human services "believes that the transplantation network must be operated by profes­ sionals in the transplant community, and that both allocation and other policies of the optn should be developed by transplant professionals. . . . it is not the desire or intention of the department to interfere in the practice of medicine."). 2011] working tile system 237 ing the nation's transplant centers.68 nota requires the optn to be operated by a private, nonprofit corpora­ tion.69 the united network for organ sharing (unos) has performed this job since 1986, and unos is the first and only corporation to operate the optn.7° keeping with the goal of allowing medical judgment to remain paramount, while assisting opos in ensuring equitable allocation of organs on a nationwide basis, the majority of unos board members are doctors and transplant surgeons working at transplant centers. 71 unos actually established the first computerized database used to match donor organs with transplant candidates before nota was enacted. 72 in 1986, federal law made membership with the optn and compli­ ance with its policies a prerequisite for payment from medicare for all hos­ pitals and op0s.73 this was the first time .a national entity unos, operating under the united states department of health and human ser­ vices' ("hhs") oversight was charged with developing legally enforcea­ ble allocation policies for all hospitals and transplant hospitals across the united states.74 congress believed that funding a national transplant net­ work could resolve many of the inequities that existed in the organ trans­ plant system. 75 congress also believed that a centralized computer network would do a better job of matching donors and recipients and that this .better matching system would also lead to less donor organs waste. 76 although congress had good intentions in creating the centralized list and matching system, data collected over the first few years of use showed that some patients were receiving organs sooner than others. 77 correlations were found between differences in waiting period and geographic location, blood type, ethnicity, and recipient age.78 even worse, data showed that organs were not being consistently given to the patients that were the sick68. 42 u.s.c § 274 (b) (2006). 69. 42 u.s.c. § 274(b)(l)(a) (2006). 70. optn, united network for organ sharing, http://www.unos.org/donation/ index.php?topic=optn (last visited sep. 15, 2010); see also galen, supra note 40, at 339. 71. 42 u.s.c. § 274(b)(l)(b) (2006). see generally opln, optniunos board of directors, health res. & sbrv. admin., http://optn.transplant.hrsa.gov/memberslboardof directors.asp (last visited sep. 15, 2010) (listing current board members). 72. galen, supra note 40, at 339. 73. 42 u.s.c.a § 1320(b)(8) (west 2006). see generally organ procurement and transplantation network, 63 fed. reg. 16,296, 16,297 (apr. 2, 1998) (to be codified at 42 c.f.r. part 121) (giving background information about legislation preceding the 1998 hhs final rule). see also galen, supra note 40, at 339. 74. galen, supra note 40, at 339-40. 75. s. rep. no. 98-382, at 13-44 (1984), reprinted in 1984 u.s.c.c.a.n. 3,979-80; see also daubert, supra note 11, at 464. 76. s. rep. no. 98-382, at 18 (1984), reprinted in 1984 u.s.c.c.a.n. 3,984 (noting increased transplants would occur due to improved ability to match donors with recipients). 77. galen, supra note 40, at 340. 78. id. 238 indianahealthlawreview [vol. 8:229 est or nearest to death. 79 in 1998, hhs released a final rule concerning these differences.80 while this rule did not establish a specific organ alloca­ tion system or express rules, 81 it did direct the optn to develop goals for standardized listing criteria to ensure that candkwes would be grouped by medical urgency and that organs would be allocated to the sickest patients.82 b. current structure and functioning of the organ transplantation process in 1999, unos developed unet, the first secure internet organ trans­ plant database.83 it is used, to match organ donors and recipients and to manage transplant data.84 after procuring· an organ from a donor, the opo will enter it into the unei database and unos determines to which patient the organ will be offered first.85 1. the relationship between transplant centers and organ procurement organizations a transplant center is simply .a medical facility. that performs organ transplantation.86 as ofmarcjt 6, 2010, there were 249.transplant centers in the united states maintaining one or more transplant programs.87 many of these centers offer multiple transplant programs. as of that date, there were 1,135 different transplant programs operating at these 249 centers across the country. 88 the transplant programs receive their organs for transplant from opos. opos are non-profit organizations that are responsible for ap­ proaching family members of deceased persons to discuss the option of or­ gan donation, evaluating medical suitability of. possible organ donors, coordinating recovery, preservation, and transportation of organs to be used for transplantation, and educating the public about the need for organ dona­ tion.89 each opo operates in an established service area, which may cover 79. id 80. organ procmement and transplantation network, 63 fed. reg. 16,296 (apr. 2, 1998) (to be codified at42 c.p.r. part 121). 81. id. 82. !d. 83. unet goes live: internet-bared technology used in transplant system, unos (oct. 22,1999), http://www.unos.o®'about/index.php?topic=newsroom&article_ id=l548 :9efa7e0fcd11169a248b9767119cb36b. 84. !d.; see also optn, supra note 70. 85. unet goes live, supra note 83. 86. optn, glossary, heal1h res. & serv. admin., http://optn.transplant.hrsa.gov/ resources/glossary.asp#t (last visited sep. 15, 2010). 87. optn, members, hbal1h res. & serv. admin., http://optn.transplant.hrsa.gov/ members/ (last visited dec. 7, 2010). 88. id. 89. optn, supra note 86. 2011] working the system 239 an entire state or only part of a state.90 currently there are fifty-eight opos operating across the united states.91 transplant hospitals and opos must be members of unos in order to receive reimbursement from medicare. 92 unos has divided the united states into eleven different regions.93 this division allows its members to facilitate organ allocation and to provide individuals with the opportunity to identify concerns regarding organ pro­ curement, allocation, and transplantation that are unique to their particular geographic area.94 with the exception of perfectly matched donor kidneys, donated organs are offered to recipients in the area from which the organ was procured (where the donation was made) before they are offered tooth­ er parts of the country.95 unos follows this system in order to reduce the time that an organ must be preserved after donation, improve organ quality and survival outcome, reduce the costs associated with transplantation, and increase access to transplantation. 96 2. unos policy for organ allocation unos policies prescribe the method in which different organs are to be allocated.97 although unos allows patients to list themselves on wait­ ing lists at multiple transplant centers for any organ transplant needed,98 this discussion will include only the policies specific to liver allocation for the purposes of simplicity and consistency. 99 furthermore, while unos poli­ cies for liver allocation and transplantation have specific criteria for pediat90. optn , regions, health res. & serv. admin., http://optn.transplant.hrsa.gov/ members/regions.asp (last visited oct. 16, 2010). 91. optn, member directory, health res. & serv. admin., http://optn.transplant. hrsa.gov/memberslsearch.asp (last visited oct. 16, 2010). 92. 42 u.s. c. § 1320(bx8) (2006). 93. optn, supra note 90. 94. /d. 95. /d. 96. /d. 97. orentlicheret al.,supranote 16, at405. 98. unos 3.2, supra note 25. 99. while allocation of each donor organ requires matching to recipients based on organ specific metrics, the allocation algorithm for each organ is similar to that of the liver policies. see generally unos, 3.5: organ distribution, allocation of deceased kidneys, health res. & serv. admin., http://optn.transplant.hrsa.gov/policiesandbylaws2/ poli­ cies/pdfs/policy_7.pdf(last updated nov. 9, 2010); unos, 3.7: organ distribution, alloca­ tion of thoracic organs, health res. & serv. admin., http://optn.transplant.hrsa.gov/ policiesandbylaws2/policieslpdfs/policy_9.pdf (last updated nov. 9, 2010); unos, 3.8: organ distribution, pancreas allocation, health res. & serv. admin., http:/ /optn.transplant.hrsa.gov/policiesandbylaws21policieslpdfslpolicy _1 o.pdf (last updated nov. 9, 20 l 0); unos, 3.11: organ distribution, intestinal organ allocation, health res. & serv. admin., http:/ /optn.transplant.hrsa.gov/policiesandbylaws2/policieslpdfslpolicy _13 .pdf (last updated june 6, 2008). 240 indiana health law review [vol. 8:229 ric patients, 100 the discussion below examines only the policies as they re­ late to adult patients. however, all portions of unos policy pertinent to this discussion are included below. unos policy 3.6 governs the process of allocating donor livers to pa­ tients on the waiting list.101 compliance with these policies is mandatory/02 and unos conducts audits when appropriate.103 after being placed on a transplant hospital's waiting list, candidates are categorized (and eventually chosen to receive the donor organ) using two methods: status code or prob­ ability of candidate death.104 physicians at the transplant center perform patient classification and scoring.105 if an·adult patient is given a status code, he or she will be given a code of la or 7.106 a patient is assigned a status code of 7 when he or she. is de­ termined to be temporarily unsuitable for a transplant and is not considered for organ allocation.107 a patient is classified as la when he or she is de­ termined to have "fulminant liver failure with a life expectancy without a liver transplant of less than 7 days."108 once given a la status code, pa­ tients are assigned points under many different categories. these categories include blood type,109 time spent waiting on the list,110 and degree ofmedi100. see generally unos, 3.6: organ distribution, a./location of livers, healtii res: & serv. admin., http:/ /optn.transplant.hrsa.gov/policiesandbylaws2/policies/pdfs/policy _ 8.pdf (last updated nov. 9, 201 0) [hereinafter unos 3.6]. 101. ld. 102. id 103. unos, 3.6.9.2: organ distribution, allocation of livers, listing accuracy and appropriateness, health res. & serv. admin., http://optn.transplant.hrsa.gov/ poli· ciesandbylaws2/policies/pdfs/policy_8.pdf (last updated nov. 9, 2010) ("any instance in which an organ is allocated to a recipient center for a transplant candidate and the host opo or any member questions the accuracy or appropriateness of the candidate's status may be reported retrospectively to the host opo's regional review board with reasons for the concern. upon receipt of two such reports regarding cases from the same institution within a one· year period, the review board shall refer the matter to the membership and professional standards committee with a request for an on·site audit of the institution."). 104. unos, 3.6.4.1: organ distribution, allocation of livers, adult candidate status, health res. & serv. admin., http://optn.transplant.hrsa.gov/policiesandbylaws2/ poli· cies/pdfs/policy_8.pdf(last updated nov. 9, 2010) [hereinafter unos 3.6.4.1]. 105. unos 3.6,supranote 100. 106. id. 107. unos 3.6.4.1, supra note 104. 108. id. (unos policy 3.6.4.1 defines "fulminant" in detail, but for the purpose of this note it is sufficient (and most important) to understand that patients placed in the la catega. ry have liver failure and have a life expectancy ofless than 7 days.). 109. unos, 3.6.2: organ distribution, a./location of livers, blood 1}pe similarity stratification/points, health res. & serv. admin., http://optn.transplant.hrsa.gov/ poli­ ciesandbylaws2/policies/pdfs/policy_8.pdf (last updated nov. 9, 2010) [hereinafter unos 3.6.2] (patients with the same blood type as the donor receive ten points. patients with com· patible, but not identical blood types receive five points. patients with a blood type that is incompatible with the donor receive zero points.). 110. unos, 3.6.3: organ distribution, allocation of livers, time waiting, health res. & serv. admin., http://optn.transplant.hrsa.gov/policiesandbylaws2/policies/ 2011] working the system 241 cal urgency.m when a patient does not fit the criteria to be placed in a given status code, he or she may still receive an organ based on probability of death. 112 a mortality risk score is determined by the physician using different medi­ cal prognostic factors113 as provided by the model for end-stage liver dis­ ease (meld} scoring system.114 once given a meld score, patients are then grouped by blood type.115 within each meld score, donor livers are offered to patients who have an identical blood type match first, followed by those patients who are blood-type compatible, followed by patients who are blood-type incompatible with the donor.116 once a patient is listed and given a status code or meld score, he or she must wait for a donor organ.117 as a patient's health changes, the scores and categorization of the patient will change.118 unos requires doc­ tors to reassess and recertify patients' status code and probability of death determination at a predetermined frequency depending upon the last score or categorization.119 when a liver becomes available, it is offered to pa­ tients based on their current status code or meld score according to the following algorithm. patients listed at a transplant hospital located in the same geographic region from where the organ was harvested with a status code of la are considered first by descending point total.120 next, candi­ dates in the same geographic region are considered by descending meld score.121 finally, if there are no regional patients that are able to take the donor liver, 122 the liver is offered to patients in the same priority on a na­ tionallevel.123 pdfs/policy_8.pdf(last updated nov. 9, 2010) (time spent on the waiting list only accrues while the patient is active (suitable for transplant). ten points are awarded to the patient that has been waiting the longest period and proportionately fewer points are accrued by those patients who have been waiting a shorter period of time.). 111. unos, 3.6.4: organ distrj,bution, allocation of livers, degree of medical urgen­ cy, health res. & serv. admin., http://optn.transplant.hrsa.gov/policiesandbylaws2/ poli­ cieslpdfslpolicy_8.pdf(last updated nov. 9, 2010). 112. unos 3.6,supranote 100. 113. as with tests used to determine the patient's status code, the specific medical crite­ rion used in the meld test is of no importance to this discussion. knowledge of its use is sufficient. 114. unos 3.6,supranote 100;seealfo unos 3.6.4.1,supranote 104. 115. unos 3.6, supra note 100. 116. unos 3.6.2,supranote 109. 117. see generally unos 3.6, supra note 100. 118. id. 119. unos, 3.6.4.1.1: organ distribution, allocation of livers, adult candidate reas­ sessment and recertification, health res. & serv. admin., http://optn.transplant.hrsa.gov/ policiesandbylaws2/policieslpdfs/policy _ 8.pdf (last updated nov. 9, 201 0). 120. unos 3.6, supra note i 00. 121. id. 122. ld. (unos leaves the final determinationwhether to use the donor organwith the transplant surgeon. this allows the surgeon to exercise judgment over the suitability of transplantation of the donor organ into the specific patient. if the surgeon decides not to use the liver, it must be returned to unos for allocation.). 123. ld. 242 indiana health law review [vol. 8:229 as noted above, when determining organ allocation, the criterion giv­ en the greatest weight is medical urgency.· however, when these factors place potential recipients into the. same status, a recipient that is "regional" will receive preference over those patients who are not. yet, these unos guidelines do not govern the transplant process until after the patient is on the waiting list. 124 while much attention is given to the shortage of donated organs as compared to the number. of potential recipients. on the waitlist, attention should also be paid to the process of adding one's name to the waitlist. ac­ cording to arthur caplan, ph.d., the chair of the department of medical ethics at the university of pennsylvania, ''the system works at two levels .... one, who gets in to a [transplant] center. two, who gets transplanted off a particular center's list when an organ becomes available. most of the attention goes to stage two, but the biggest ethical challenges are really at stage one."125 3. not all organ procurement organizations are created equal if all transplant centers had similar access to organs, patients needing an organ transplant would gain no advantage by listing themselves on mul­ tiple waiting lists. this, however, is not the case. · the problem or the advantage for some patients is that not all opos are created equal. some regions contain nearly fifteen times as many people as others, and their waiting list times vary widely. patients in small opos tend to be. less sick and experience short­ er wait times before getting an organ.126 examining the performance ofthe fifty-eight opos across the united states shows a significant variation among them. for example, the tables below show statistics for 2007 and 2008 for opos located in and serving california (where steve jobs lives) and tennessee (where steve jobs re­ ceived his liver transplant). while tennessee donor services serves the less populous state of tennessee, 127 in 2007 and 2008 it actually outper­ formed california's golden state donor services. tennessee donor ser­ vices procured more organs overall, more organs per donor, more organs 124. 0rentlicher et al., supra note 16, at 409. 125. hainer, supra note l. 126. /d. 127. u.s. census bureau, 8tatisticalabstractof1heunl:tedstates: 2008, 17-18 (2008), available at http://www.census.gov/prod/2007pubs/08abstract/pop.pdf (stating that in 2006, california ranked first among states in terms of population with 36,458,000 resi­ dents, while tennessee ranked seventeenth with 6,039,000 residents). 2011] working the system 243 transplanted per donor, and more of that opo's organs were actually used for transplant (see tables 1 and 2 below). further, golden state donor services fell below the united states average for all of these categories while tennessee·donor services exceeded the nationwide average in both years (see tables 1.-3 below). year 2007 2008 year 2007 2008 year 2007 2008 table 1: california golden state donor serviees128 toollorpas organs organ tr11111plants tralllplants performed reeovered reeovered per per donor type using organs proenred donor type by this organization 178 3.18 2.86 160 184 3.17 2.91 169 table l; tennessee.:... tenn~see donor serviees129 total organs organs organ trlllllplants . transplants performed n.eeovered reeovered per per donor type using organs procured donor type by this organization 717 3.66 3.12 612 717 3.81 3.19 599 table 3: united states average130 organs reeovered per donor type 3.5 3.49 organs transplants per donor type 3.0 3.0 4. not all transplant centers are created equal even if all opos were able to provide donor organs equally to all transplant centers, a ciifficulty for patients would remain. not all transplant centers provide the same transplant services. in other words, not all trans­ plant hospitals have programs for transplantation of all organs. in addition, waitlist numbers and procedures performed vary greatly between centers. further, as shown by tables 4 and 5, not all centers have the same patient survival rates. 128. srtr, golden state donor services, sacramento, ca. cagsopixx, 5 (july 2009), available at http:/lwww.ustransplant.org/csr/archives/200906/cagsopixx2 00906.pdf. 129. srtr, tennessee donor services, .nashville, tn, tndsoplxx, 5 (july 2009), available at http://www.ustransplant.orglcsr/archives/200906/tndsopixx2009 06.pdf. 130. srtr, supra note 128. 244 indiana health law review [vol. 8:229 as shown in tables 4 and 5, various transplant centers located in dif­ ferent areas of the united states function quite differently. transplants per­ formed using deceased donors varied widely between centers within the same state as well as those located in different states. the number of pa­ tients on each center's waitlist also varied greatly. at frrst glance, these statistics appear to show the rate at which patients are given transplants. this, however,· is not the case. instead, these numbers show the relative consistency in the number of patients waiting at each transplant center. in addition, it is important to note that the centers differ from one another in the rate of transplants performed, adult graft survival rate, and adult patient survival rate one year after transplant surgery. these differences indicate that, as with any other medical treatment or procedure, organ transplant outcomes vary at different centers across the united states. table 4: sample of transplant centers performing kidney transelants in california 2008131 adult patleall patient deeeased patlenllon on transplant adult survival donor center's transplant center's rate among graft rate transwaitlistat center waitlist waitllsted survival one plants bealamng at.eud patleatl rate year performed ofl008 ofl008 after surgery "not arrowhead ''not statistiregional "statistically statistical4 74 69. lower" than lydiffercally medical differcenter expected ent"than ent"than expected ex ted ''not "not cedars"statistically signifisignifisinai med100 473 2s8 higher" than cantly cantly different" differ.ical center expected than ent"than expected expected 131. srtr, arrowhead regional miidical center, colton, ca, casbtxlki (july 2009), available at http://www.ustransplant.orgfcsr/archives/200906/casbtx 1 ki 200906.pdf; srtr, cedars-sinai medical center. i..os angeles, ca, cacstxlki (july 2009), available at http://www.ustransplant.orgfcsr/archives/200906/cacstxlki 200906.pdf. 2011] working the system 245 table 5: sample of transplant centers performing kidney transj!lants in tennessee 2008132 adult patients deceased patients on patient oncentransplant adult donor center's survival transplant ter's rate among graft transwaitllstat rate one center waitlist waitusted survival plants beginning year at end patients rate performed of :zoos of2008 after surgery "statisti"not centennial "statistically cally statisticalmedical 31 158 159 higher" than lower" ly differcenter expected than ent"than expected expected ''not ''not nashville veterans "statistically signifisignifiadministra15 179 193 lower'' than candy candy differdifferent" tion expected hospital ent"than than expected expected 5. unos allows multiple listings current unos policies and bylaws expressly allow patients in need of an organ transplant to be listed on multiple waiting lists.133 in fact, each transplant program must inform all patients of the option to be listed at mul­ tiple centers upon accepting that patient onto its waiting list.134 in order to avoid inefficiencies, unos policies prescribe procedures to remove a pa­ tient from all of the lists he or she is on soon after that patient receives a transplant or dies.135 132. srtr, centennial medical center, nashville,. 1n, 1npvtx1k.i (july 2009), available at http://www.ustransplant.org/csr/archives/20090611npvtx1k.i200906.pdf; sr tr, centennial medical center, nashville,. 1n, 1npvtx 1 k.l (july 2009), available at http:/ /www.ustransplant.org/csr/archives/20090611npvtx1k.i200906.pdf. 133. unos 3.2, supra note 25. 134. unos, 3.2.3: organ distribution, unos patient waiting list, waiting time transferral and multiple listing, health res. & serv. admin., http://optn.transplant. hrsa.gov/policiesandbylaws2/policies/pdfs/policy_ 4.pdf [hereinafter unos 3.2.3] (last up­ dated nov. 9, 2010). 135. see generally unos, 3.2.2: organ distribution, unos patient waiting list, mul­ tiple listings permitted, health res. & serv. admin., http://optn.transplant.hrsa.gov/ poli­ ciesandbylaws2/policies/pdfslpolicy_ 4.pdf (last updated nov. 9, 2010); unos 3.2.3, supra note 132; unos, 3.2.4: organ distribution, unos patient waiting list, match system ac­ cess, health res. & serv. admin., http://optn.transplant.hrsa.gov/policiesandbylaws2/ policies/pdfs/policy_ 4.pdf(last updated nov. 9, 2010). 246 indiana health law review [vol. 8:229 iii. patients in need of an organ transplant should continue to be allowed to place themselves on thew ait list at multiple transplant ceni'ers one possible way to stop the potential inequities of the current system would be to limit patients to listing themselves at local transplant centers only. if the current system for organ allocation and transplantation should be changed, now might be an opportune time to do so. an overhaul of health care in the united states is currently underway, 136 and legislators have a prime opportunity to change systems that they find inefficient as the changes called for in the law are being shaped. however, the appropriate­ ness of the timing alone does not mean that the system should be changed. the system should be changed only if the changes would prove to be ad­ vantageous to the general transplant patient population overall. a. arguments in favor of allowing patients to place themselves on multiple waitlists 1. patient autonomy in treatment choices the marketplace in the united states is generally based on a "free­ market" system.137 this system allows consumers to choose the products and services that they wish to purchase.138 this freedom of consumer choice may create incentives for companies and individuals who sell goods and services to create the highest quality products at the lowest possible price.139 this freedom of choice is also a notable aspect of the united states health care system. like the free market system in place for consum­ er goods, this system likely gives doctors and hospitals incentive to provide the highest quality of care. while prices in healthcare are more likely to be determined by, or in the least influenced by, the federal government (by setting payment schedules for medicare) and private insurance and third party payers, the quality of patient care will still be affected by this freedom of choice. in the end, patient safety and quality outcomes are the most im­ portant aspects of health care. as shown previously in this note, opos functioning in different re136. see generally patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010) (to be codified as an1ended at scattered sections of 42 u.s.c.), available at http://www.gpo.gov:80/fdsyslpkg/pla w-lllpubll48/pdf7pla w-1llpubll48.pdf. 137. frederick c. thayer, regulation is inevitable: legal planning or illegal collu­ sion?, 32 am. u. l. rev. 425, 425-26 (1983). see also josh clark, is a free market "free, if it's regulated? (oct. 3, 2008), http://money.howstuffworks.com/ftee..market-economy .htm (suggesting that the united states marketplace is based on the idea of a free market but is also regulated by the government). 138. see clark, supra note 137. 139. ld 2011] working the system 247 gions provide patients with different opportunities to receive the organ they need. 140 tables 1 and 2 showed the different amounts of organs that are recovered throughout the region that each opo served. table 3 showed that some opos function at levels below the national average and others exceed national figures. further, tables 4 and 5 showed that different transplant centers have different outcomes in their transplantation programs. these outcome based differences include the number of transplants per­ formed, the way the actual number of transplants performed compared to the number of expected transplants the hospital, and varying outcomes from the actual transplant surgery, which include graft survival rates and, more importantly, patient survival rate one-year post surgery. patients who are on a waitlist for organ transplant are often in a life or death situation. if they do not receive the organ they need, death may be the likely outcome. on the other hand, receiving a necessary organ can be a sort of "stay of execution" in that it places the patient in a situation where a return to healthy living is possible to some extent. in almost any other situ­ ation where an adult patient is in need of medical treatment, the patient is granted the right to consent, or deny consent, for that treatment.141 if all financial variables are set aside, and the patient consents to treatment, he or she should have the right to choose from which doctor to seek treatment. undoubtedly, this decision is made by weighing multiple factors including, but not limited to, treatment availability and outcomes, rapport with the doctor and surgeon, the experience or expertise of the doctor and surgeon, and hospital reputation. the current system permitting patients to list them­ selves at multiple transplant hospitals reserves the patient's decision­ making autonomy by allowing the patient to determine what doctors and surgeons he or she feels most comfortable with. the current system also allows the patient to seek transplant centers with the best outcomes. be­ cause different opos function at different levels, requiring a patient to only be listed at the nearest transplant center may force the patient to be treated at a center that provides a lesser chance of survival. certainly if a patient is allowed to make the choice of which doctor to go to for a simple yearly physical examination, the same autonomy should be allowed in a decision with the gravity of life and death. while many patients do -have health insurance, it may not cover the entire expense of organ transplantation surgery or aftercare. for example, medicare pays for the direct cost of transplantation of many different or140. see supra notes 128-132 and accompanying text and tables. 141. see generally in re conroy, 486 a.2d 1209, 1226 (n.j. 1985) (holding that a com­ petent patient has the right to give and deny consent for treatment absent a third party inter­ est); mcfall v. shimp, 10 pa. d. & c.3d 90, 91-92 (allegheny county 1978) (holding that a patient has the right to refuse unwanted bodily intrusion); orentlicher et al., supra note 16, at 355-56. 248 indiana heal til law review [vol. 8:229 gans, but it does not cover all the costs associated with the transplant.142 private insurance, similar to medicare, often offers incomplete coverage of transplant costs. 143 this incomplete coverage may preclude patients, under private insurance or medicare, from receiving a transplant at a hospital out of their financial reach. the current system would allow a patient to place him or herself on waitlists at transplant centers that are most affordable in his or her financial situation. a system that would require patients to go to their local center might price patients out of the ability to have their surgery. as previously mentioned, many transplant hospitals do not perform transplants of every organ. further, the type of available organs varies widely between different geographic areas of the united states.144 a regu­ lation limiting patients to listing themselves with local centers may bar some patients from the surgery they would need to live based solely on availability. clearly, a regulation having this effect would require an ex­ ception for a patient in such a situation. the criteria used to decide whether or not to place a patient on a wait list vary between physicians and transplant centers.145 in addition, because unos does not have regulations that mandate how transplant centers oper­ ate, there can be a large variation in transplant center practices.146 the cur­ rent system allows patients to find a surgeon and transplant center that have criteria the patient satisfies so he or she can be placed on the wait list. also, the system allows patients to list themselves at transplant centers where they feel most confident in the transplant process. a system allowing only local wait listing might both keep patients in need from getting on a wait list (if they were not able to satisfy the requirements for entrance onto the local list) and force patients to list themselves at a facility where they are not confident in the possible outcome. to alleviate the problems that would arise in limiting patients to only list themselves at the local transplant center, unos could limit each patient to one entry on a waiting list without geographic limitation. however, in this situation the argument for inequality would still exist, because patients with modest financial means would be unable to travel to a transplant center located far from their home, while a wealthy patient could travel to different centers and decide which gave him or her the best opportunity for a sue142. orentlicheret al.,supra note 16, at404. 143. /d. 144. unos rationale for objectives of equitable organ allocation, unos (jan. 15, 1996), http://www.unos.org/about/index.php?topic=newsroom&article_ id=l503: 85b3dc451eb0ded52b3121dc59c438dc. 145. see generally orentlicher et al., supra note 16, at 403-4 (suggesting that differ­ ent transplant centers give different weight to factors including, but not limited to, the likeli­ hood of successful surgery, ability to pay, benefit the particular patient will gain from the transplant, organ rejection, quality of life, cause of organ failure (such as alcoholism in liver failure), concomitant illness, age, drug abuse, and mental status). 146. unos rationale for objectives of equitable organ allocation, supra note 144. 2011] working the system 249 cessful outcome. thus, limiting a patient to only one listing based on geog­ raphy does not alleviate the possibility of inequality between the rich and the poor. while the current system can be criticized for potential inequality due to fmancial means, it appears to be better than these other two options. the first alternative infringes upon patient autonomy in treatment and po­ tentially decreases successful outcomes by forcing patients to wait at a par­ ticular center irrespective of organ availability in that region, center procedure, and outcome statistics. the second alternative does not alleviate the latent inequality that may exist within the present system. 2. multiple wait listing may potentially help patients who are only on a single list one might argue that the current system creates an inequality that fa­ vors the wealthy; however, this system has the potential to help those listed only on a single local list as well. a wealthy patient who gets a necessary organ transplant at a center outside of his or her locality will then be re­ moved from (or not even placed on) the locallist.147 for example, consider patient x and patient y who have the same blood type, need the same organ, and are given the same meld score. pa­ tient x and patient y are both listed at transplant hospital 1, but patient x was placed onto the wait list one day before patient y. the median wait time at transplant hospital 1 is much higher than the national average. if patient x has the financial and physical means to travel around the united states and to be listed at transplant hospitals 2, 3, 4, and 5, his chances of getting the needed organ before death significantly increase. patient y does not have the financial and physical means to be listed at all of these centers. however, patient y may still benefit from the current system. if patient x receives an organ transplant from any of transplant hospitals 2-5, he will immediately be removed from the waitlist at transplant hospital 1. thus, an organ that would have gone to patient x will go to patient y instead. if patient x had been required to list himself only at a single local center, pa­ tient y would not receive this benefit.148 147. unos, 3.2.2.3: organ distribution, unos patient waiting list, unet notifica­ tion of transplantation or death of multiple listed candidates, health res. & serv. admin., http://optn.transplant.hrsa.gov/policiesandbylaws2/policies/pdfs/policy _ 4.pdf (last updated nov. 9, 2010) ("transplant centers will be notified through the unet system when a multiple listed candidate has been transplanted or reported as deceased by another center so that all other centers involved can investigate and request removal of the candidate from the center's waiting list."). 148. the counter to this argument is that patient x took an organ from a third patient listed at transplant hospital 2-5 who only had the financial means to list himself at one of these transplant hospitals. see disc\lssion infra at part iii.b.2. 250 indiana health law review [vol. 8:229 3. economic argument allowing those with the financial and physical means to place them­ selves on multiple waitlists can benefit society. steve jobs' case is a good example of this. apple is a company that has benefitted greatly from its ceo's actions.149 jobs was one of the founding fathers of the company and under his leadership apple's worth has grown from $5 billion in 2000 to $170 billion in 2009.150 if jobs was limited to a single wait list, he likely would have undergone his transplant later or died. under either of these scenarios, apple would have suffered with the loss or prolonged illness of its ce0.151 allowing someone with the financial means to decrease the time spent waiting for a transplant improved the lives of those who benefit from apple products. the current system also has a financial impact on the public. if jobs was not able to return to his company as quickly as he did (or if he died as a result of not receiving a transplant), apple's stock prices might have de­ creased further, and those with money in the market would have suffered if they had invested in apple. more directly, apple is a large corporation that employs 34,000 people. 152 if the company would have suffered further, many of its employees could have lost their jobs. further, someone left unemployed may also be left without health insurance, and if she also need­ ed a transplant, she may be left with no ability to pay for the procedure. as previously discussed, inability to pay may preclude a patient from even be­ ing entered onto a wait list, 153 and death may occur as a result. obviously, not every organ recipient has as direct an impact on the economy as steve jobs does. however, a recipient who has the financial means to place him or herself on multiple waitlists ·likely does effect the economy in a similar manner, only on a smaller scale. further, in the case that another prominent figure in the business world is in need of an organ transplant, allowing him or her to be placed on multiple waitlists will allow the same positive eco­ nomic benefit. 149. adam lashinsky, the decade of steve: how apple's imperious, brilliant ceo transformed american business, cnn money (nov. 5, 2009), http://money.cnn.com/ 2009/11104/technology/steve _jobs.:_ ceo_ decade.fortunefmdex.htm. 150. id. 151. steve jobs takes medical leave, apple stocks plunge, llvemint & the wall street journal (jan. 15, 2009), http://www.livemintcom/2009/01/15092803/steve-jobs­ takes-medical-leave.html (explaining that the price of apple's stock dropped 7.07% in the hours following jobs' announcement that he would be taking a leave of absence related to his medical issues). 152. lashinsky, supra note 149. 153. orentlicher et al., supra note 16, at 404; see also hainer, supra note 1. 2011] working the system 4. enforcing wait time equity frustrates the two goals of hhs in relation to organ transplantation a. minimal waste of organs 251 the time interval between procurement of an organ from the donor and surgical transplant into the patient is referred to as "cold ischemia time."154 as cold ischemia time increases, the likelihood of successful or­ gan transplantation decreases.155 therefore, one important factor in mini­ mizing waste of organs is to ensure that they are transplanted as quickly as possible in order to keep cold ischemia time to a minimum. as described above, 156 unos policies for organ allocation offer an organ to the patient with a status code of ia and the highest point total who is at a hospital located in the same vicinity where the organ is procured.157 if the transplant surgeon decides that the organ received is not suitable for transplant in a particular patient, the organ is allocated to the next best can­ didate.15g often, this candidate may be at a different transplant center. when this occurs, the donor organ must be transported to the center. after being offered locally, the organ is then offered on a nationwide basis.159 obviously, as the distance between the donation site and the transplant cen­ ter that accepts the organ increases, the time taken to transport the organ increases. while this process occurs, the time that the donor organ goes without perfusion of blood (the cold ischemia time) increases and the likeli­ hood of successful transplantation decreases. because the transplant sur­ geon ultimately decides whether an organ is appropriate for transplantation into a patient based on his or her ·medical judgment, and because the amount of cold ischemia time is one predictor of successful transplantation, it is highly likely that a sui:geon will decline an organ that has a high cold ischemia time. after an organ is declined for transplant into the first poten­ tial recipient, it becomes increasingly likely that the organ may not be used due to cold ischemia time. what was initially a valuable organ can become unusable and therefore wasted. allowing multiple listing can help decrease the chance of wasted or154. glossary of relevant and relaled terms: cold ischemia time (cit). srtr. http://www.ustransplant.org/glossary.aspx?term=cold%20ischemiao/o20time%20(cit) (last visited oct. 16, 2010) 155. james e. stahl et at •• consequences of cold-ischemia time on primary nonfunc­ tion and patient and graft survival in liver transplantation: a meta-analysis, plos onj;, 67 (jmte 6, 2008) http://www.plosone.org/articlelinfo:doio/o2f 10.1371 o/o2fjoumal.pone. 0002468. 156. see discussion ofunos liver allocation policies, supra notes 99-125 and accompanying text. 157. unos 3.6. supra note 100. 158. id 159. jd. 252 indiana health law review [vol. 8:229 gans due to increased cold ischemia time by placing a patient who may be the best fit for a transplant in multiple localities. the same financial re­ sources that allowed the patient to list him or herself at transplant centers across the country will also usually allow him or her to travel quickly to the area where the donor organ is procured. in other words, if a perfectly matched organ is procured at a distance from the patient's home, he or she can travel quickly to the center during the procurement process to the local hospital in that area to decrease cold ischemia time. when this occurs, the organ will be offered to a patient who is a perfect fit rather than the next patient down the list who may not have been as good a fit. the chance of the transplant surgeon declining the organ will decrease, thus decreasing the possibility of organ wasting. in the case of steve jobs, it was determined that he would be the best match for an organ procured in tennessee. his financial means allowed him to travel from california to tennessee quickly enough to keep the cold ischemia time of the donor liver to a minimum, allowing for a successful transplantation. further, by placing himself on multiple lists, jobs was able to minimize the problem of a high cold ische­ mia and increase the likelihood that an organ matching his specific needs would be found. when an organ matches well with the recipient, the chances of a surgeon declining it are usually minimal and the organ will not go to waste. b. maximum survival rates (i) better matching between donor organ and recipient. in order for survival rates to remain high, organs must be matched well to recipients.160 when an organ becomes available, it is first offered to a patient with a la status code and the highest point score in the same lo­ cality from which the donor organ was procured.161 as discussed above, 162 when a patient appears on multiple lists, the chance that an organ will go to a well matched recipient increases because he or she is considered based on medical criteria rather than geographic location. thus, the organ is more likely to be matched with a recipient patient needing an organ of that size, blood type, and other pertinent criteria. (ii) transplant tourism. in 2007, the united nations expressed concerns about a rising number of "transplant tourism" cases where people in countries including paki160. this is evidenced by the allocation policies that give priority scoring to patients with the same or similar medical characteristics such as blood type. see unos 3.6, supra note 100. 161. /d. 162. there is an increased likelihood of a good match between first potential recipient and the offered donor organ; therefore, there is a decreased chance that a surgeon would decline the organ for that particular patient. see supra note 122. 2011] working the system 253 stan, egypt, and the philippines were selling their body parts to people from other countries.163 because of advancements in transplantation surgery, more patients seel4 and are eligible for, organ transplantation.164 however, waiting lists have remained long and some wealthy patients have turned to purchasing organs and tissues that are not essential for survival from the less fortunate in other countries.165 farhat moazam of the sindh institute of urology and transplantation notes the increased number of people traveling to pakistan to buy kidneys, saying, "there are villages that are in the poorer parts of pakistan where as many as 40 to 50 percent of the population of the village we know only has one kidney." this is a prime example of the fear that congress had of making the "poor a source of spare parts for the rich" when it enacted not a.166 while the practice of transplant tourism may give a patient access to a desperately needed organ, it may also place the patient in a perilous posi­ tion. patients receiving transplants in foreign countries take on the risks associated with having a surgical procedure in a jurisdiction not governed by the safety standards that apply in the united states. thus, the patient may have higher risks of infection and of receiving an organ that is not a medically appropriate match. while the natural instinct is to think ofhhs's goal of maximum sur­ vival rates in terms of the recipient, it should also be thought of as the goal for living donors. this is not an issue when the donor is already deceased, but it is paramount in the case of a living donor who consents to donation of organs such as a kidney, partial lung, or bone marrow. according to luc noel of the world health organization's health and technology and phar­ maceuticals unit, many of the people who sell their organs and tissues are not given proper follow-up medical care and their health risks increase, thus decreasing their potential for survival.167 noel further explains that "[l]ive donations are not without risk, whether the organ is paid for or not. the donor must receive proper medical follow-up but this is often lacking when he or she is seen as a means to making a profit."168 those opposed to allowing patients to wait list themselves at multiple transplant centers may argue that "transplant tourism" is occurring right now while multiple listing is allowed. however, disallowing multiple wait listing may increase the likelihood that the wealthy will turn to this practice. 163. laura macinnis, "tr011splant tourism" on rise due to donor shortages, reuters health (mar. 30, 2007), http://www.reuters.com/articlelidusl3042128920070330. 164. /d 165. id. (''the wealthy, in. search of their own survival, will sometimes seek organs from the poor."). 166. hearings, supra note 58, at 248. 167. macinnis, supra note 163. 168. press release, world health organization. who proposes global agenda on transplantation, new world observatory launched with spain (mar. 30, 2007), available at http://www.who.int/mediacentrelnews/releases/2007/pr12/en/index.html. 254 indiana health law review [vol. 8:229 in order to engage in transplant tourism, the patient must be healthy enough to travel to a foreign country for a transplant surgery. if a patient is healthy enough to travel to the other side of the world, it is unlikely that he or she would get ala status code or a high meld score. thus, he or she would be placed at the end of the waiting list and may have to wait a very long time before being offered a donor organ. in these cases, the transplant tour­ ism option may seem particularly appealing if this patient lives in an area where the wait time for the needed organ is exceptionally long. while al­ lowing multiple wait listing has not stopped the practice of transplant tour­ ism, it at least offers a more attractive, and potentially safer option. (iii) competition may generate improved processes and techniques transplant centers with higher survival rates are likely to be solicited more by those able to list at multiple centers and survival rates may im­ prove accordingly. while nota protects against organ commoditization by prohibiting individuals from benefitting financially from organ dona­ tion,169 it permits opos and transplant centers to receive "reasonable pay­ ments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ. "170 thus, the parties involved in harvesting, transporting, and transplanting the organ, as well as caring for the patient, stand to gain financially by performing these services. as a result, each party has incentive to provide the best services to the most people possible in order to gain the most payment possible. if a center is known to have particularly positive outcomes, it follows that pa­ tients who have the means to travel are more likely·to list themselves at that center. this potential will incentivize centers to provide services rendering the best outcomes. when this occurs, it leads to efforts to improve the pro­ cesses of procurement and transplantation. if patients were only allowed to list themselves at the transplant center in the area where they are domiciled, the incentive for the center to improve may be diminished because the pa­ tient does not have the option of seeking these services elsewhere and will settle for whatever services the local center provides. b. arguments for disallowing patients to place themselves on multiple waitlists 1. public view of the fairness of the system affects the likelihood of donation organ harvesting can only occur if the patient or the appropriate fami­ ly member gives consent.171 those opposed to multiple wait listing may 169. 42 u.s.c. § 274e (2006). 170. 42 u.s.c.a. § 274(e)(c)(2) (west 2003). 171. see generally mcfall v. shimp, 10 pa. d. & c.3d 90, 90. (allegheny county 1978) (holding that a patient has the right to refuse unwanted bodily intrusion). see also brother2011] working tim system 255 argue that the number of people willing to make donations will decrease if people find that the organ transplant process unfairly benefits the wealthy. this argument would have more validity if the current system did not allow multiple listings and was being changed to do so. in such a situation, the change would gain public attention and could sour the public's view of the system. however, this system has been in place since 1984.172 because the system is long~standing, the fact that multiple wait listing is allowed seems to gain attention only when well~known americans undergo an organ trans~ plant in an area far from their home.173 while it may be argued that this media attention highlights an aspect of the process that may influence potential donors to not donate their or­ gans, the effect may actually be the opposite. while the attention may tend to focus on a potential inequality, it does not highlight any illegal activity by the actor because unos policies. expressly allow multiple listings.174 while it initially focuses on the actions of the wealthy patient, attention may quickly turn to the large disparity between the number of organs do­ nated and the number of patients in need waiting on the list. after learning of this disparity, it is entirely possible that people may be inspired to donate their organs. or to be sure to make their wishes to be a donor known. fur­ ther, the current culture of the united states seems to be one that is very interested in the activities of the rich and famous. if a well-liked celebrity has a successful organ transplant, he or she may be more likely to become an organ donor, and in a culture that follows the lead of its celebrities, this may lead to many others doing the same. 2. allowing multiple listings "pushes" a truly local patient down the list further and forces him to wait longer logically, any time that a patient awaiting a transplant is awarded an organ, every other. person on that same list is forced to wait for the next possible match. while the preceding portions of this note have discussed the ability of a patient to decrease their waiting time by placing him or her­ self on multiple lists, no attention has been given to the patients that remain on the list once the patient listed at multiple centers receives an organ. for example, if unos did not allow listings in areas where a patient does not live, steve jobs (a california resident) would not have been able to place himself on the waitlist at the transplant center in tennessee and a patient behind him on that list would have received that liver. while this is true, ton v. cleveland, 923 f.2d 477 (6th cir. 1991) (aggregating property rights to create an enti­ tlement interest in the body of the deceased and disallowing removal of corneal tissue with­ out consent). 172. national organ transplant act, pub. l. no. 98-507,98 stat. 2339 (1984) (codified as amended at 42 u.s.c. § 273-74 (2006)). 173. the attention that the transplant system gained after steve jobs' transplant is a perfect example of this. see hainer, supra note l. 174. unos 3.2,supranote25. 256 indiana health law review [vol. 8:229 this difference is negated on a nationwide scale. after jobs received his liver in tennessee, unos policy required his removal from all other wait­ lists and patients on each of these lists moved one step closer to the life sav­ ing liver transplant that they had been desperately waiting for. for further explanation, recall the aforementioned hypothetical con­ sidering patient x and patient y who have the same blood type, need the same organ, and are given the same meld score.175 both patients are listed at transplant hospital 1, but patient x was placed onto the wait list one day before patient y. patient x is also listed at transplant hospitals 2, 3, 4, and 5. patient x receives a transplant at transplant hospital 2 and patient y benefits (as previously described). while this is clearly a poten­ tial benefit for patient y, patient z listed at transplant hospital2 has been bumped down the list because patient x has been listed ahead of him. pa­ tient z has now effectively been placed one spot lower than if patient x was required to list himself only at his local transplant center. while this is true, patient x will only receive an organ from one of the transplant centers where he was listed. in the current example, patient z will actually only be affected twenty percent of the time that he and patient x have the same transplant criteria. more often, patient x will be removed from the list that patient z is on. because unos requires patient x to be removed from all other lists, 176 no inefficiency will occur from patient x remaining on lists after receiving his transplant. more importantly, patient x would not have listed himself at transplant hospitals 2-5 unless these facilities already had a low median wait time. the transplant hospital where patient x receives his organ operates with an opo which has proven that it was quickest at procuring a particular organ for that particular type of recipient and the wait at this center is still likely shorter than the national median wait time. while patient z may have an increased wait list a small percentage of the time, the overall effect will likely be increased efficiency. iv. conclusion the national organ transplant act of 1984 addressed congress's concerns over the medical and ethical issues involved in the evolving field of organ transplantation.177 congress wisely chose to leave decisions about the medical criteria involved in organ allocation and transplantation to med­ ical professionals.178 in doing so, congress left the decisions concerning organ procurement, transportation, allocation, and procedures to transplan175. see supra part iii.a.2. 176. unos, supra note 145. 177. s. rep. no. 98-382, at 2-4 (1984), reprinted in 1984 u.s.c.c.a.n. 3,975, 3978. see also 42 u.s.c. § 273-274 (2006). 178. 42 u.s.c.a. § 274(b)(2) (west 2003); organ procurement and transplantation network. 63 fed. reg. 16,296, 16,300 (apr. 2, 1998) (to be codified at 42 c.f.r.part 121). 2011] working the system 257 tation professionals and those on the board at unos.179 currently, unos policies allow patients the option of placing themselves on multiple wait­ lists, in unlimited geographical areas.180 recently, the fact that steve jobs received a liver transplant at a hospital located in tennessee gained media attention and turned the public's attention to this potential inequity in unos's organ allocation policy.181 while some members of the public may then view the organ allocation process in a negative light, continuing to allow patients to list themselves at multiple transplant centers is the best of all potential options. patient autonomy is an important aspect oftoday's health care system. patients are free to make decisions concerning which treatments they wish to participate in, and which ones they wish to forgo. furthermore, patients are essentially free to decide which health care providers they consult, and from whom they receive treatment. nowhere is this autonomy more im­ portant than in the situation where a patient's life is at stake, which is fre­ quently the case for those seeking transplants. as previously discussed/82 opos functioning in different geographic regions procure organs at differ­ ent rates. therefore, patients on the waiting list of the transplant centers served by these opos have different median wait times before receiving the organ that they so desperately need. in addition, transplant centers have different procedures and surgical outcomes. if unos policies are changed to require patients to be wait-listed only at the transplant center nearest their home, these patients will be stripped of their autonomy at the time they likely have the most interest in making these decisions. if, instead, they are able to maintain their autonomy, patients are likely to choose the transplant center that gives them the best chance at survival. because opos and transplant centers make a profit in the organ transplant process, the ability of patients to choose their transplant center will likely incentivize the opos and transplant centers to function at the most efficient and most cost effec­ tive manner possible. proponents of creating a new unos policy restricting multiple wait listing may argue that the current system, coupled with the current media attention that the policies are receiving, may cause the public to distrust the organ allocation system and dissuade them from becoming an organ donor. while this attention may decrease the likelihood of a small percentage of potential organ donors, it is not likely that this will have much impact on the number of organ donors. first, this unos policy has been in place for years. the mass attention given to this policy occurs only when the media covers a famous person who has used the system to his advantage (as in steve jobs' case). in a culture that is very interested in its celebrities and 179. see generally 42 u.s.c § 273-74 (2006). 180. unos 3.2, supra note 25. 181. hainer, supra note 1. 182. see supra notes 128-132 and accompanying text. 258 indiana health law review [vol. 8:229 often follows therr lead, this media attention could actually cause the public to become more interested in organ donation. while some may argue that the current system allows the wealthy to ''push" those less fortunate out of line, multiple wait listing may actually benefit those who are only on a single list while only increasing the wait of these single listed patients a small percentage ofthe time.183 multiple wait listing may also help achieve hhs's goal of minimal wasting of organs by decreasing cold ischemia time related to transporting an organ from donor to recipient. additionally it helps ensure safety (while improving out­ comes) by offering the most suitable match based on medical criteria while improving the ability to keep organs local to decrease the cold ischemia time. the current system also helps ensure the safety of those donating nonessential organs by decreasing the likelihood that the wealthy will turn to transplant tourism, 184 thus decreasing the likelihood that the poor will become a "source of spare parts for the rich."185 while it is likely true that the current unos policies allowing multi­ ple wait listing may cause a small portion of the american public to view the organ transplant system in a negative light, the benefits that the system offers strongly outweigh the potential negative impact caused by media. because of the strength of the arguments for keeping the current policies in effect, maintaining the status quo is clearly the best option. 183. see discussion supra at parts illa.2 and ill.b.2. 184. see discussion supra parts illa.4. 185. hearings, supra note 58, at 218. human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? hooman movassagh, phd* i. introduction .................................................................. 83 ii. iran’s regulatory context ........................................ 89 iii. shiite approaches to human organ transplants .......................................................... 93 a. transplant of cadaveric organs ............................................. 94 b. compensation for human organs .......................................... 98 iv. the regulation and legal nature of organ transplantation in iran ................................................. 102 a. compensated live organ donations .................................... 103 b. cadaveric organ transplants ............................................... 106 c. the legal nature of compensated live organ donation .... 109 v. ambiguous transactions and absurd consequences ............................................................ 111 vi. conclusion ............................................................... 117 * the author is a fellow at the institute for practical ethics & public life at the university of virginia. previously, he was a lecturer at shahid beheshti university (sbu) law school (2002-2012); the director of the bioethics group of the center and unesco chair for human rights, peace and democracy of sbu, tehran (2009-2012); and visiting professor (2013-2014) and scholar (2012-2014) at the university of virginia school of law. the author thanks dr. james f. childress (university of virginia) and dr. mohammad rasekh (shahid beheshti university) for their helpful suggestions and comments on an earlier draft of this paper. he also wishes to gratefully acknowledge the input by the following uva faculty on the substance of this paper at a colloquium at uva school of law: richard j. bonnie, margaret f. riley, lois shepherd, and dr. gil siegal. last but not least, the author wishes to thank his wife, leili monfared, for having patiently read and expertly commented on earlier drafts. “needless to say, i take full responsibility for the paper as it now stands.” http://dx.doi.org/10.18060/3911.0013 2016 83 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? abstract the national organ transplant act has been unsuccessful in overcoming human organ shortages in the united states. there are calls for compensating human organ donations that refer to the “iranian model.” the iranian model is a compensated scheme for organ donations that is often mistakenly thought of as a “sale” of organs. the reality is, within the context of the iranian legal system, the compensation is for the act of donation and is characterized as a contract of “reward.” given the specific regulations on the different forms of contract under the iranian civil code, this characterization holds significant legal and ethical importance. a sale of human organs under the civil code would result in the immediate ownership of the organ by the purchaser, whereas this would be an absurd result under iranian law. a proper understanding of the iranian model is essential for potential regulatory reform in the united states. this paper sets out a precise clarification of the legal intricacies of human organ donations in iran. keywords: organ donation, health policy, medical law, iran, contracts, law and religion, islam. i. introduction while transplanting human organs is currently a widely accepted practice, ethical concerns continue to exist about certain aspects of this procedure1 that affect national legal 1 such concerns existed from the very first organ transplant, see cornelia dean, a conversation with: joseph e. murray; on surgical innovation and the questions it can raise, n.y. times (sept. 25, 2001), http://www.nytimes.com/2001/09/25/health/conversation-with-joseph-emurray-surgical-innovation-questions-it-can-raise.html [http://perma.cc/ hd3y-s6ep] (discussing the late dr. joseph e. murray who performed the first kidney transplant in 1954 and how he was criticized for “playing god” for intending to do the transplant). the ethical aspects and concerns surrounding human organ transplants have also been echoed in international fora. see world health org. [who], ethics, access and safety in tissue and organ transplantation: issues of global concern, at 84 indiana health law review vol. 13:1 frameworks for human organ transplants. of particular concern are compensated schemes for organ donations and the attendant possibility of commercialization. although providing compensation to organ donors is currently banned in most countries and by international regulations on human organ transplants,2 there are calls by academics and activists 9, who/htp/eht/t-2003.1 (oct. 6-9, 2003), available at http:// www.who.int/ethics/tissue%20and%20organ%20transplantation.pdf [http://perma.cc/7e9b-dfgf] (“[dr biller-andorno] enumerated ethical concerns that can arise in the areas of deceased and living donors as well as tissue and xenotransplants. common to all four areas are questions of eligibility and safety of donor and recipient, use of financial and other incentives, equitable access and allocation and issues of cross-border exchanges and commercialization. she pointed out some of the major issues that need to be addressed, keeping the 1991 guiding principles in mind. these include on what grounds live donation can still be considered subsidiary to cadaveric donation, continuing and more complex issues of donor and recipient safety, voluntary status of consents and how best to preserve the principle of non-commercialization.”); see also world health assembly [wha], who guiding principles on human organ transplantation, res. wha44.25 (may 13, 1991), available at http://www.transplant-observatory.org/sitecollectiondocuments/ wha44resen.pdf [http://perma.cc/7ebk-u84a] (the “guiding principles on human organ transplantation” were developed by the world health organization and declared on may 13, 1991, by a resolution of the world health assembly. the resolution contains nine guiding principles that are “intended to provide an orderly, ethical, and acceptable framework for regulating the acquisition and transplantation of human organs for therapeutic purposes.”); see also who, who guiding principles on human cell, tissue and organ transplantation [hereinafter who guiding principles], available at http://www.who.int/transplantation/ guiding_principlestransplantation_wha63.22en.pdf?ua=1 [http:// perma.cc/e5jz-p52p] (developing the guiding principles into eleven principles that was issued in another resolution of the wha in 2010). 2 see who, supra note 1; see also additional protocol to the convention on human rights and biomedicine concerning transplantation of organs and tissues of human origin, art. 21, opened for signature jan. 24, 2002, c.e.t.s. no. 186, available at http://conventions.coe.int/treaty/en/treaties/html/186.htm [http:// perma.cc/l5j4-4sfx] (“1the human body and its parts shall not, as such, give rise to financial gain or comparable advantage. the aforementioned provision shall not prevent payments which do not constitute a financial gain or a comparable advantage, in particular: compensation of living donors for loss of earnings and any other justifiable expenses caused by the removal or by the related medical examinations; payment of a justifiable fee for legitimate medical or related technical services rendered in connection with transplantation; 2016 85 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? to enable some form of compensation to donors in order to overcome the organ shortage that is costing thousands of lives every year.3 in the united states, the national organ transplant act of 1984 prohibits organ purchases but permits certain forms of compensation, including for lost wages and hospital costs.4 however, this and other incentives in force in the united states have proved insufficient to encourage live organ donations. deceased donor organs fall far short of what is needed to prevent the suffering and death of thousands of people, such that 4,300 people died in the united states while on the transplant waiting list in 2013 alone.5 as a result, providing compensation to organ donors is currently being discussed as one of the means of providing sufficient incentive to live donors and to overcome the organ shortage in the united states. a recurring reference in the discussions on compensated organ donations is iran’s organ transplant system. iran’s incentivized system of organ donations includes a scored system of transplant waiting lists for organ recipients, 6 exemption of organ donors from military service, 7 and a compensation in case of undue damage resulting from the removal of organs or tissues from living persons. 2advertising the need for, or availability of, organs or tissues, with a view to offering or seeking financial gain or comparable advantage, shall be prohibited.”). 3 see generally sally satel, when altruism isn’t enough: the case for compensating kidney donors (2008); sigrid fry-revere, the kidney sellers: a journey of discovery in iran (2014); sally satel et al., state organ-donation incentives under the national organ transplant act, 77 l. & contemp. probs. 217 (2014). 4 42 u.s.c. § 274e (2015). 5 satel et al., supra note 3, at 217. 6 for example, if a candidate for transplant is an organ donor, they are accorded four points on the waiting list, thus receiving higher priority over a non-organ donor candidate. see mashhad univ. of med. sci. transplant procurement unit, protocol-e paivand-e kollie [kidney transplant protocol] 23-24 (2011), available at http:// www.mums.ac.ir/shares/tmc/arghamia2/maghalat/prokidnynomosavab.p df [http://perma.cc/jwt9-xzua]. (the original source and its translation are on file with the indiana health law review.). 7 ehda konandegan ozv az sarbazi moaf mishavand [organ donors will be exempt from military service], iranian students’ news agency (iran), may 20, 2013, available at http://tinyurl.com/m9wvllg [http:// 86 indiana health law review vol. 13:1 compensated scheme of organ donations. the latter aspect of the iranian system has been of interest in the debates on compensated organ donations, but has invariably been misunderstood as a system that authorizes the sale of organs. the payment of compensation is not synonymous with the sale and purchase of organs. the possibility of providing some form of compensation, regardless of whether or not it is done with the purpose of providing financial incentives to donors, does not necessarily mean that human organs are being bought and sold. conflating the two has led to some ambiguities and misunderstandings about the regulated framework of organ transplants in iran, to such an extent that the terms “kidney sellers,”8 “organ sales” 9 and “kidney ebay” 10 have been used in describing the “iranian model.”11 this confusion is understandable, since the term “sale” is sometimes loosely used in connection with organ donations within iran itself, particularly by laypersons. also, the majority of iran’s population are shiite muslims, and many of the decrees issued by leading shiite clerics have also used the term “sale and purchase” of organs when responding to questions on the religious aspects of organ donations. however, it must be emphasized that this is not a correct characterization.12 in fact, iran’s regulations have not used this term with respect to human organ donations, and the perma.cc/4sxx-2dd9]. (the original source and its translation are on file with the indiana health law review.). 8 frye-revere, supra note 3. 9 benjamin e. hippen, organ sales and moral travails: lessons from the living kidney vendor program in iran, cato inst. (march 20, 2008), http://www.cato.org/publications/policy-analysis/organ-salesmoral-travails-lessons-living-kidney-vendor-program-iran [http:// perma.cc/ mrl8-726w]. 10 saeed kamali dehghan, kidneys for sale: poor iranians compete to sell their organs, guardian (may 27, 2012), http:// www.guardian.co.uk/world/2012/may/27/iran-legal-tradekidney?intcmp=srch [http://perma.cc/n62d-mkqv]. 11 this phrase has been used to describe the specific scheme of organ donations in iran whereby certain cases may be compensated. see hippen, supra note 9; ahad j. ghods & shekoufeh savaj, iranian model of paid and regulated living-unrelated kidney donation, 1 clinical j. am. soc’y nephrology 1136 (2006). 12 as will be seen below, the views of shiite clerics are not uniform on this either. http://dx.doi.org/10.2215/cjn.00700206 2016 87 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? official terms used are “donation” (e’ta) and “gift” (ehda). far from being merely pedantic, this characterization has considerable ethical and legal significance under iran’s legal system. a contract of sale is a specific type of contract in iran’s civil code and has a well-defined regime. if the donation is deemed a sale, one may be faced with the scene depicted by shakespeare in the merchant of venice where shylock insists on having his pound of flesh: the pound of flesh, which i demand of him, is dearly bought; ‘tis mine and i will have it. if you deny me, fie upon your law! there is no force in the decrees of venice. i stand for judgment: answer; shall i have it?13 in the case of legal organ transplants, the life of any given “antonio” may not necessarily be endangered quite as depicted by shakespeare.14 however, the question whether or not human organs may be deemed to be property, or for some reason subject to purchase and ownership, may raise a host of other issues. such issues may include the donors’ consent, defining an acceptable transaction in form and substance, and the plethora of issues that arise from attributing ownership rights to human organs, such as the various legal relations between the donors, recipients, and third parties. the fact that iranian regulations differentiate between transplants using cadaveric organs and those provided by live donors is relevant here. with respect to organs obtained from live donors, a certain sum may be paid as a reward for 13 william shakespeare, the merchant of venice act 4, sc. 1. although shakespeare was not addressing a question of organ donation or sale, the nature of the transaction under which donations are made may well result in such a scenario if the matter is not addressed sufficiently. it is essential that even in a compensated scheme for organ donations, safeguards be established to protect the rights and freedoms of the parties involved. 14 id. shylock, through his hatred of antonio, insists that he must cut the flesh closest to antonio’s heart: “so says the bond: doth it not, noble judge? ‘nearest his heart’: those are the very words.” 88 indiana health law review vol. 13:1 the “sacrifice” the donor has made,15 although the donor may decide to forego such compensation for altruistic or other reasons. however, no such compensation has been allowed in cadaveric organ transplants. providing safeguards against ownership claims to human organs and for ensuring a donor’s consent throughout a transplant procedure are extremely important.16 an incorrect portrayal of the iranian system may result in a demand for similar systems being established elsewhere without enough attention to the safeguards inherent in the nature of the act of donation under iranian law and the additional assurances of propriety included in relevant regulations and enforcement mechanisms. certainly, the iranian system itself requires further elaboration of regulations and strengthening of mechanisms and safeguards. also needed is greater national awareness of the range of relevant ethical and legal aspects of transplants and a much necessary clarification of the transactions being conducted outside the defined legal scheme for live unrelated donations. 17 however, despite the shortcomings of the iranian system, there are legal safeguards that must be taken into account when considering the “iranian model.” 15 known as “hediye’ye isar”, literally meaning “gift of sacrifice.” the term is also used in regulations concerning disability pay for certain veterans. 16 the case of mr. hu jie, a migrant worker who changed his mind about undergoing a transplant in china but was nevertheless stripped of his kidney, illustrates this importance all too well. see nicola davison, in china, criminals fill the kidney donor deficit, guardian (may 27, 2012, 15:00 edt), http://www.guardian.co.uk/world/2012/may/27/chinakidney-donor-shortage-crime [http://perma.cc/35ej-uuzf]. 17 although there are guidelines and information pamphlets on many of the websites and centers relevant to organ transplants, see, e.g., shahid beheshti u. med. sci. organ procurement unit, http:// ehda.sbmu.ac.ir/?fkeyid=&siteid=489&pageid=34190 [https://perma.cc/ wp22-dfk5] (last visited dec. 2, 2015). there are at times incorrect portrayals of the system in popular media that may lead to further ambiguities or misunderstandings about organ donation. furthermore, the law is ambiguous on the nature of human organs and the nonsystemic transactions conducted by the public. these ambiguities are addressed below. (the original source and its translation are on file with the indiana health law review.). 2016 89 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? this matter is of no small importance in view of the ethical and legal ramifications of compensated organ donations, the millions of people who stand to benefit from a healthier life, and the immense financial aspects involved. therefore, with the purpose of disambiguation, a brief overview of the regulatory framework of the iranian model is provided, and the legal nature of donations under that system is analyzed. ii. iran’s regulatory context iran is an “islamic republic.” this phrase means that while certain processes and institutions of government are republican in form and structure, according to article 4 of the iranian constitution “all, civil, penal financial, economic, administrative, cultural, military, political, and other laws and regulations must be based on islamic criteria.” 18 furthermore, by virtue of article 170 of the iranian constitution, judges shall not give effect to laws or regulations that contradict islamic criteria. 19 thus, the 18 qanuni assassi jumhurii islamai iran [the constitution of the islamic republic of iran] 1358 [1980], art. 4. this article’s islamic principle “governs absolutely and generally all articles of the constitution, as well as all other laws and regulations, and the duty to ascertain this matter devolves on the jurists of the guardian council.” the constitution mentions such determination is to take place by the six clergy members of the guardian council or “fuqaha,” a term that has been incorrectly translated to “the wise persons,” see, e.g., iranconstitution, http://www.servat.unibe.ch/icl/ir00000_.html [http:// perma.cc/ph3u-zj5w] (last visited feb. 1, 2016), or simply “jurists,” see, e.g., islamic parliament of iran, http://en.parliran.ir/ index.aspx?siteid=84&pageid=3053 [https://perma.cc/27q8-6qjp] (last visited oct. 26, 2015). it must be noted that the guardian council consists of twelve members, six of whom are legal jurists and six who are islamic jurists (faqih). a determination on the compatibility of laws and regulations with islamic shari’a is incumbent on the islamic jurists, and ascertaining the compatibility with the constitution rests with all twelve members of the council. 19 qanuni assassi jumhurii islamai iran [the constitution of the islamic republic of iran] 1358 [1980], art. 170. “judges are obliged to refrain from” executing byelaws “and regulations of the government that are in conflict with the laws or the norms of islam,” or have been adopted by the executive ultra vires. anyone has the right to “demand 90 indiana health law review vol. 13:1 drafters of the iranian constitution have posited islamic shari’a as the general moral theory of the entire legal system of iran, permeating all laws and regulations, and determined by the clerical members of the guardian council. 20 obviously, not all issues have been addressed in the shari'a and modern advances in science and technology may pose a challenge to legislation on a strict reading of this provision. interestingly, the iranian constitution has used different terms concerning the relation of legislation and shari’a. for example, articles 4 and 94 provide that legislation has to correspond to “islamic criteria;” a different phrase in articles 72, 85, 91 and 96 indicates that legislation must not contradict the “rules of islam.”21 the guardian council has commented on this differentiation in defining its work22 and the annulment of any such regulation from the court of administrative justice.” 20 by virtue of article 12 of the constitution, the official school of islamic shari'a incumbent on the state has been declared to be that of the twelver ja’faris. qanuni assassi jumhurii islamai iran [the constitution of the islamic republic of iran] 1358 [1980], art. 12. this article provides: the official religion of iran is islam and the madhhab (school of law) is the twelver ja’farí school, and this article will remain forever unalterable. other legal schools (madhãhib) including the hanafi, shãfi’í, mãlikí, hanbalí, and zaydí, are accorded full respect, and their followers are free to perform their religious rites in accordance with their own fiqh. these schools are officially recognized by the courts in matters pertaining to religious education and training, personal status (marriage, divorce, inheritance, and wills), and any related litigation. in any region where the followers of any of these schools constitute a majority, the local regulations will be in accordance with that school within the jurisdiction of the local councils, with due observance of the rights of the adherents of other schools. for a definition of madhhab and further resources on the subject, see encyclopedia of islam (p. bearman, et al. eds., 2nd ed. 2012), available at http://referenceworks.brillonline.com/entries/encyclopaedia-of-islam2/madhhab-sim_8798 [http://perma.cc/qvl7-pwwj]. 21 qanuni assassi jumhurii islamai iran [the constitution of the islamic republic of iran] 1358 [1980], arts. 4, 72, 85, 91, 94, 96. 22 see about the guardian council, guardian council, http:// www.shora-gc.ir/portal/home/ showpage.aspx?object=news&id= 7ca3f12d-47c1-4ac5-a088-397771794abb&layoutid=e3152b95-620e2016 91 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? has held that the former formulation refers to the general principles of shari'a such as justice, fairness, and human dignity, whereas the latter denotes such specific rules23 that have expressly been set forth in the quran and the sunnat.24 the council believes these formulations are co-extensive and there is no contradiction between them. 25 instead, the iranian constitution provides a broader discretion to the council in ascertaining that legislation “corresponds to islamic criteria” and is more restrictive if legislation is found to “contradict specific rules of islam.”26 this system enables the guardian council to take into consideration various policy issues when reviewing legislation passed by parliament (the majlis) and possibly to opt for an interpretation of shari’a that would meet modern policy necessities. this is important since islamic law may lack specific rules on issues raised by the advent of new technologies and advances in science, and such a reading provides more leeway for enacting any legislation that may be required for regulating such advances. furthermore, the most prominent islamic jurists (fuqaha) hold differing views on many issues, 27 including the question of organ transplants, and these views may in certain exceptional circumstances be a source for adjudication of particular legal claims in courts of law. 4dfd-97f1-1fefd0f696b1&categoryid=8fac823a-5745-41b6-a9e2b879c74deb7b [http:// perma.cc/55t9-cx4y] (last visited oct. 26, 2015). (the original source and its translation are on file with the indiana health law review.). 23 see encyclopedia of islam, second edition: ahkam, brillonline reference works, http://referenceworks.brillonline.com/entries/ encyclopaedia-of-islam-2/ahkam-sim_0376 [http://perma.cc/wkc3q3yg] (last visited oct. 28, 2015). 24 also written as “sunna” or “sunnah,” generally meaning the practice and custom of prophet mohammad, which in addition to the quran, is a source of islamic law, see encyclopedia of islam, second edition: sunna, brillonline reference works, http:// referenceworks.brillonline.com/entries/encyclopaedia-of-islam-2/sunnacom_1123 [http://perma.cc/t2x2-bcje] (last visited oct. 28, 2015). 25 infra note 29. 26 see about the guardian council supra note 22. 27 see abdulaziz sachedina, islamic biomedical ethics: principles and applications (2009), available at http:// course.sdu.edu.cn/ download/20130908092939153.pdf [http://perma.cc/ v9s4-4wjg]. 92 indiana health law review vol. 13:1 finally, in the event that there is a difference of opinion between the parliament and the guardian council on necessary policy considerations and islamic criteria, the constitution has established the expediency assembly to resolve the dispute between the two entities.28 this is to prevent a stalemate between the legislative policy requirements of everyday life as determined by parliament and the possible inflexibility of the guardian council on a specific issue.29 as a result, the drafting process for legislation, and even regulation by entities other than parliament, necessarily takes into consideration the dictates of shari’a with regard to any given issue. this is not to say that other facets are ignored in toto. in drafting legislation, regard is also given to iran’s international obligations, policy requirements and questions of practicality, and the results of studies in various sciences relevant to the issue. however, the tenets of shari'a and the views of the most highly regarded and most authoritative islamic jurists of the shiites (maraji’) will 28 the constitution of the islamic republic of iran oct. 24, 1979, art. 112. article 112 of the iranian constitution reads in part: “the state expediency assembly will meet by the order of the leader to decide what is most expedient whenever the guardian council considers a bill approved by the islamic parliament of iran to be contrary to the principles of the shari’a or the constitution and the parliament is unable to secure the satisfaction of the guardian council on the basis of national expediency. the state expediency assembly will also meet to consult on any issue referred to it by the leader or related to its duties as mentioned in this constitution.” 29 in an interpretation of article 4 of the constitution by the guardian council, even the expediency assembly is barred from approving any legislation that contradicts islamic criteria. majmuahi nazariati shurai nigahban [compilation of the opinions of the guardian council] tehran 1993, op. 4575. however, since this opinion appeared to contradict the very raison d’être of the expediency assembly, it was asked to elaborate its position. letter from expediency assembly, letter no. 3786/2409 (june 24, 1993). the guardian council responded by pointing to the differentiation between the primary and secondary rules of shari'a and declared that the constitutional provision on the expediency assembly’s purview relates to that of secondary rules. guardian council, op. 4872 (1993). in practice, once the expediency assembly approves an act of parliament, it is published in the official gazette as law and becomes binding. (the original sources and their translations are on file with the indiana health law review.). 2016 93 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? usually hold sway over conclusions that may be drawn from other moral theories that dominate either the international or “western” policy deliberations. as a result, different regulatory conclusions may be reached in a setting where concepts such as autonomy, dignity, equality, liberty, and harm may have different meaning, scope, or importance in moral and policy deliberations. iii. shiite approaches to human organ transplants notwithstanding the provisions of the constitution for the purpose of legislation and the role of the guardian council, any real or legal person may seek the views of the shiite maraji’ resulting in religious decrees (fatawa) with regard to questions of shari’a requirements on certain issues. in turn these views may affect the regulatory process and content of any legislation or regulation on the matter. however, such decrees are not always uniform, and at least for legislative purposes in iran, the guardian council will invariably be the ultimate source of authority on questions of shari'a. still, a review of the different fatawa will serve to provide a clearer picture of the context of the iranian regulations on organ donation. in the context of organ transplants, the criteria for death, donors and recipients, the possibility of compensation for donation, and even the sale and purchase of organs have been the subject of numerous decrees issued by a number of the maraji’. a review of the said decrees shows a variety of views ranging from rejecting cadaveric organ transplants to their acceptance and a range of approaches on the many questions pertaining to each position. 30 there is also a general 30 the review undertaken for this study consisted of decrees issued by fifty-two of the living and deceased maraji’. these are grand ayatollahs: mirza javad gharavi aliari, abdollah javadi-amoli, sayyid abdul-karim mousavi ardebili, ali asghar rahimi azad, sayyid ali mohammad dastgheib shirazi, mirza yadollah duzduzani, mohammad ishaq fayyadh, mohammad hossein fazlollah, mohammad taghi bahjat foomani, ali safi golpaygani, lotfollah safi golpaygani, mohammad ali gerami, sayyid mohammad ali alavi hosseini gorgani, sayyid kazim hussaini haeri, sayyid mohammad saeed tabatabai hakeem, hossein noori hamedani, sayyid kamal heydari, mohammad ebrahim jannaati, sayyid mohammad ali moosavi jazayeri, qorban ali kaboli, sayyid ali 94 indiana health law review vol. 13:1 acceptance of the possibility for the sale of organs by live donors for the purpose of transplantation, sometimes expressly restricted to cases where a life may be saved by the process. of course, not every one of the said maraji’ has addressed every aspect of organ transplants. however, for the purposes of this paper, the decrees will be categorized on the basis of their rejection or acceptance of cadaveric transplants and the question of compensation for organs.31 a. transplant of cadaveric organs among the shiite religious authorities, some have considered certain cadaveric transplants contrary to shari’a and thus have declared them wrong and prohibited. such decrees generally emanate from a rejection of the brain death hoseyni khamenei, sayyid abolghasem khoei, sayyid ruhollah khomeini, hossein vahid khorasani, mohammad fazel lankarani, moslem malakouti, hossein mazaheri (esfahani), sayyid mohammad taqi modarresi, mohammad asif mohseni, hossein ali montazeri, bashir hussain najafi, muhammad hussain najafi, sayyid reza hosseini nassab, mohammad reza nekoonam, sayyid mohammad sadeq hosayni rohani, yousuf saanei, sayyid mohammad shahroudi, sayyid mahmoud hashemi shahroudi, naser makarem shirazi, sayyid mohammad hussaini shirazi, sayyid sadiq hussaini shirazi, sayyid ali husayni sistani, ja'far sobhani, mirza javad tabrizi, sayyid yousef madani tabrizi, saleh taei, mohammad sadeghi tehrani, mojtaba tehrani, shamsodin vaezi, mohammad yaqoobi, asadollah bayyat zanjani, sayyid mohammad ezodin hosseini zanjani. of this group of fifty-two, twenty-three have issued decrees on the question of organ transplants. for a list of living and deceased maraji’ see maraji’-e taghlid-e shiie [shiite maraji’] http://fa.wikishia.net/view/%d9%85%d8%b1%d8%a7% d8%ac%d8%b9_%d8%aa%d9%82%d9%84%db%8c%d8%af_%d8% b4%db%8c%d8% b9%d9%87 [https://perma.cc/un6z-8v3l] (last visited jan. 9, 2016). 31 decrees concerning other indirectly relevant matters shall not be addressed in their own right, but only insofar as they may shed light on the issues covered in this paper. the decrees issued by some of the maraji’ cover such questions as: xenotransplants; the cleanliness of an organ in the religious sense (tahara); whether or not there is any difference between organs of muslims and non-muslims; the special status of people condemned to death; the responsibility of medical professionals in conducting transplants; and whether blood money (diya) should be paid for transplants. 2016 95 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? criterion,32 or what the relevant marja’ considers to be the desecration of a muslim’s corpse;33 but some maraji’ clearly state that extraction of organs for the purpose of transplants is not desecration34 and even consider it to be a duty to save lives.35 in cases where the brain death criterion has been rejected, cadaveric transplants have been deemed permissible where the islamic criteria for death are met,36 32 mohammad taghi bahjat foomani, jarahi, tashrih, va paivand [surgery, autopsy, and transplantation], fatwa no. 1173, http://www.bahjat.ir/index.php/ahkam-2/esteftahat/192-2011-09-06-1013-34.html [http://perma.cc/ep3w-r2j9] (last visited oct. 28, 2015); hossein vahid khorasani, ehdaye ozv dar soorate marge maghzi [organ donation in case of brain death], the office of grand ayatullah al-uzma shaykh husayn vahid khorasani, http://www.wahidkhorasani.com/web/index.php?option=com_quickfaq& view=category&cid=50&itemid=704&lang=fa [http://perma.cc/] (last visited oct. 30, 2015); sayyid ali husayni sistani, ministry of health & med. educ., http://www.behdasht.gov.ir/ index.aspx?siteid= 1&pageid=13186&newsview=4767 [http://perma.cc/ qbm6-km7e] (last visited nov. 1, 2015); ministry of health & med. educ., http://www.behdasht.gov.ir/ index.aspx?siteid=1&pageid=13186& newsview=4763 [perma.cc/akt4-kzzr] (last visited nov. 1, 2015); ministry of health & med. educ., http://www.behdasht.gov.ir/ index.aspx?siteid=1&pageid=13186&newsview=4762 [perma.cc/r9e5azpk] (last visited nov. 1, 2015). (the original sources and their translation are on file with the indiana health law review.). 33 tozih-ol masa’el [catechism] 574 (n.d.), available at http:// www.sistani.org/files-new/book-pdf/persian-tozih-edition32.pdf [https:// perma.cc/23ju-qe2g]. (the original source and its translation are on file with the indiana health law review.). 34 sayyid mohammad sadeq hosayni rohani, http:// www.rohani.ir/istefta-772.htm [http://perma.cc/2jf8-pmb3] (last visited nov. 1, 2015). (the original source and its translation are on file with the indiana health law review.). 35 mohammad sadeghi tehrani, resale-ye-tozih-ol-masaele novin [catechism on new problems], 450 question 997 (3rd ed. 2005), available at http://forghan.org/images/book/pdf/resale%20novin.pdf [https://perma.cc/g9cv-g93v]. (the original source and its translation are on file with the indiana health law review.). 36 sayyid mahmoud hashemi shahroudi, marge maghzi [brain death], http://hashemishahroudi.org/fa/pages/print.php?page= question&id=629; sayyid mahmoud [https://perma.cc/7usv-76lr]; hashemi shahroudi, pezeshki [medicine], http://hashemishahroudi.org/ fa/pages/question.php?id=133 [https://perma.cc/xj2u-79bk]. (the original sources and their translation are on file with the indiana health law review.). http://www.wahidkhorasani.com/web/index.php?option=com_quickfaq&view=category&cid=50&itemid=704&lang=fa http://www.wahidkhorasani.com/web/index.php?option=com_quickfaq&view=category&cid=50&itemid=704&lang=fa 96 indiana health law review vol. 13:1 even in the absence of a will and testament concerning organ donation and with the sole purpose of saving a muslim life.37 the general contention that muslims do not regard the definition of death as a merely scientific determination and that “the most critical issues in the determination of the time of death are essentially religious and ethical, not medical or scientific[,]”38 is true in the majority of cases, and most of the maraji’ contend that brain death in itself is insufficient to consider a person dead.39 but a number of the maraji’ have ceded such determination to medical professionals, thereby accepting the brain death criterion, 40 and one very authoritative marja’ considers death as being defined by the “custom of experts”–that of medical professionals.41 there are also nuances among the majority on cadaveric transplants, brought about by individual appreciations of changes in socio-cultural circumstances and developments in medicine, and some have accepted transplants using organs from brain dead persons in order to save lives without addressing the criterion of death itself.42 interestingly, one 37 foomani, supra note 32, fatwa no. 1178-1183. 38 sachedina supra note 26, at 145-46. 39 for instance, sayyid mohammad ezodin hosseini zanjani references a verse of the quran, zumar 42, and clearly states that brain death does not constitute death in the religious sense. nevertheless, he believes that if brain death is irreversible by any means and the brain dead person has expressed consent to donation of organs, that person’s organs may be extracted and used in transplants, shokoohe marja’iat [glory of religious authority], montakhab-e estefta’at-e jadid [selection of new fatwas] http://azanjani.blogfa.com/8908.aspx [http://perma.cc/ 46xz-dtcj] (last visited nov. 1, 2015). (the original sources and their translation are on file with the indiana health law review.). 40 mohammad ishaq fayyadh, alfayadh.org, http://alfayadh.org/ fa/#post?type=post&id=1079 [http://perma.cc/8sx6-nhmb] (last visited nov. 1, 2015); naser makarem shirazi, ahkame shar’i-e mortabet ba marg-e maghzi [shari’a decrees on brain-death], http:// makarem.ir/main.aspx?typeinfo=21&lid=0&catid=667&mid=9990 [https://perma.cc/v8zg-a6q3] (last visited jan. 13, 2016). (the original sources and their translation are on file with the indiana health law review.). 41 hossein ali montazeri, ahkam-e-pezeshki [medical decrees] 120 (3rd ed. 2002) (question 268). (the original source and its translation are on file with the indiana health law review.). 42 sayyid kazim hussaini haeri, alestefta’at [requests for fatwas], http://www.alhaeri.org/main.php#qa [http://perma.cc/ 3wy4-d8jc] 2016 97 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? marja’ makes a distinction between the brain death criterion for the purpose of organ transplants, and the shari'a criteria of death for other legal or religious purposes such as power of attorney or burial.43 according to the majority position, cadaveric transplants may take place if the life of a muslim is dependent on the procedure.44 this approach also has a number of variations. for instance, certain maraji’ have held that if a muslim’s life is in danger, the organs of a cadaver may be used to save that person’s life, even without the consent of the decedent or any other third party.45 at times, the transplant of organs has been made conditional—it must take place with the sole purpose of saving a life (or a muslim life) and it is forbidden if it is known to be futile.46 (follow “masa’el fi-tashrih wa naghl-ol-a’aza [questions on autopsy and transplantation of organs]). (the original sources and their translation are on file with the indiana health law review.). 43 naser makarem shirazi, payvande ozve kasi ke marge maghzi shodeh [transplanting the organ of someone who is brain-dead], http://makarem.ir/main.aspx?typeinfo=21&lid=0&catid=28962&mid=23 72 [https://perma.cc/77x9-kfgp] (last visited jan. 13, 2016). (the original source and its translation are on file with the indiana health law review.). 44 haeri, supra note 42. 45 mohammad taghi bahjat foomani, pezeshki [medicine] fatwa no. 544, http://www.bahjat.org/index.php/ahkam-2/esteftahat/105-2011-0906-09-19-55.html [http://perma.cc/3gzc-dlyg] (last visited nov. 1, 2015). (the original sources and their translation are on file with the indiana health law review.). 46 montazeri, supra note 41, at 129 (question 286); foomani, supra note 45, fatwa no. 552; mohammad ishaq fayyadh, alfayadh.org, http://alfayadh.org/fa/#post?type=post&id=1084 [https://perma.cc/d564uva2]; sayyid mohammad saeed tabatabai hakeem, http:// alhakeem.com/persian/pages/quesans/listgroup_ques.php?where=236 [http://perma.cc/ au2u-q9qu] (last visited nov. 1, 2015). the current leader of iran, sayyid ali hoseyni khamenei, does not differentiate between muslims and non-muslims, see sayyid ali hoseyni khamenei, http://nahad.sbmu.ac.ir/?siteid=269&pageid=20612 [http://perma.cc/ a2zd-ptmb] (last visited nov. 1, 2015). but the former leader did make such a differentiation, see sayyid ruhollah khomeini, tashrih-o paivand [autopsy and transplantation], islamic thought found., www.imamkhomeini.com/web1/persian/showitem.aspx?cid=915&pid= 2014&h=1&f=2 [http://perma.cc/2lhk-sq74] (last visited nov. 1, 2015). (the original sources and their translation are on file with the indiana health law review.). http://www.bahjat.org/index.php/ahkam-2/esteftahat/105-2011-09-06-09-19-55.html http://www.bahjat.org/index.php/ahkam-2/esteftahat/105-2011-09-06-09-19-55.html 98 indiana health law review vol. 13:1 b. compensation for human organs on the question of compensation or sale and purchase of organs, the approach of the maraji’ in the past has been to ban such sale on the grounds that it was futile and would not have any reasonable benefit, because a human organ was considered to be economically worthless.47 in view of medical developments that have made organ transplants highly beneficial in saving lives and restoring good health, decrees have been issued to reflect the economic aspect of these developments and thus to enable such transactions. 48 a majority of the maraji’ have clearly stated that the sale and purchase of organs is permissible, 49 while others have cautioned that the transaction should be conducted under another contractual category, such as release, assignment, gift, license, or mutual good deed (reciprocity).50 47 see mir sajjad hashemi, asare hoghooghie vagozarie ozve ensane morde ya mobtala be marge maghzi [legal consequences of transferring the organs of a deceased or brain-dead person], andisheh taghrib periodical 50-71 (2006). (the original sources and their translation are on file with the indiana health law review.). 48 sayyid ali hoseyni khamenei, estefta’at-e jadid [new questions], www.leader.ir/tree/print.php?catid=49&nodeid=n14609 [http://perma.cc/jh9e-4lmx] (last visited jan. 14, 2016). (the original sources and their translation are on file with the indiana health law review.). 49 this is usually with the caveat that the transplant must not be harmful to the donor. hossein ali montazeri uses the “serious and irreversible harm” formula, montazeri supra note 41, at 131 (question 296); sayyid ali husayni sistani only mentions “serious harm”, catechism, supra note 33 at 575. some of the maraji’ have stated that while it is permissible, it is best to be abstained from, mohammad ebrahim jannaati, http://www.jannaati.com/far/index.php?page=6&row= 6&start=36 [http://perma.cc/gr7r-akdu], while others have not mentioned such a restriction, khomeini, supra note 46; hossein mazaheri (esfahani), www.almazaheri.ir/farsi/print/print.aspx?tblname= publicquestion&id=484 [http://perma.cc/8qjl-l5wj] (last visited nov. 1, 2015); tehrani, supra note 35, 451 fatwa no. 1000. (the original sources and their translations are on file with the indiana health law review.). 50 mohammad ali gerami uses the term raf’e yad (dispossession). see mohammad ali gerami, gerami.org, www.ayat-gerami.ir/ data.asp?l=1&id=3048 [http://perma.cc/k33r-segk] (last visited nov. 1, 2015). sayyid ali hoseyni khamenei uses the term foroosh (sell) on 2016 99 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? it appears that these decrees have been issued with the belief that due to developments in modern medicine, the trade of human organs may be considered rationally beneficial and hence, capable of being transferred in a sale and purchase agreement.51 however, there are decrees that restrict this position. the position that a transplant should take place only in cases where it offers hope for saving a life and is not futile also applies to the sale and purchase of organs.52 some of the maraji’ have also declared the sale of organs by persons condemned to death to be illegal.53 however, three occasions, see khamenei supra note 48; sayyid ali hoseyni khamenei, http://www.leader.ir/tree/index.php?catid=11 [http://perma.cc/ 8hgd-y2ee] (last visited nov. 1, 2015) (questions 1291 and 1518). but, in another fatwa, he specifies that organ donation may be carried out as “assignment,” khamenei, supra note 46. naser makarem shirazi believes “license” is the better form of transaction, see naser makarem shirazi, paivande tokhmdane zan-e ajnabi be zojeh [transplantation of an unrelated woman’s ovary to a married woman] http://makarem.ir/main.aspx?typeinfo=21&lid=0&catid=28962&mid=24 35 [https://perma.cc/p6h9-tk8y]. sayyid mohammad sadeq hosayni rohani has classified the transfer of gametes and embryos as a “gift,” sayyid mohammad sadeq hosayni rohani http://www.rohani.ir/istefta777.htm [http://perma.cc/q936-gr8w] (last visited nov. 1, 2015), and believes that the sale of organs or cadavers for conducting autopsies is impermissible, sayyid mohammad sadeq hosayni rohani http://www.rohani.ir/istefta-1336.htm [http://perma.cc/u52q-7534] (last visited nov. 1, 2015). yousuf saanei believes that while the sale and purchase of organs is permissible per se, the transaction is best to be carried out under some other rubric, such as a mutual good deed. he believes the sale and purchase of organs may result in the belittlement of the islamic republic [of iran]. see yousuf saanei, esteftaat-epezeshki [religious decrees on medicine] 138-139 (12th ed. 2009). (the original sources and their translation are on file with the indiana health law review.). 51 hossein noori hamedani, hezar-o yek mas’aleh fiqhi [a thousand and one problems of fiqh], 255 (n.d.), available at http://www.noorihamedani.com/files/51d16dbcb0642.pdf [https://perma.cc/y5d6-p4ez]. (the original source and its translation are on file with the indiana health law review.). 52 foomani, supra note 45, pezeshki [medicine] fatwa no. 506; sayyid mohammad shahroudi, fatwa no. 1793, www.shahroudi.com/ portal.aspx?pid=71243&caseid=34311 [http://perma.cc/e8k3-mn33] (last visited nov. 1, 2015). (the original sources and their translation are on file with the indiana health law review.). 53 foomani, supra note 45, pezeshki [medicine] fatwa no. 543. 100 indiana health law review vol. 13:1 there are decrees that provide the possibility of donating organs to benefit from a lesser punishment. for instance, sayyid kazim hussaini haeri has issued a decree stating that in cases where a person who is condemned to death is willing to donate an organ to benefit from a lesser punishment and the judge has the power and discretion to issue a lesser punishment, such donation is permissible.54 this fatwa does not address the issue of monetary compensation; rather it addresses a non-monetary incentive that seriously calls into question the autonomy of such donors. there is also general agreement that the sale of organs does not devolve upon the heirs of a decedent by way of inheritance. such heirs may only endorse or reject the donation of the decedent’s organs, but may not receive any sums for such donation.55 this is a peculiar position and it raises the question whether the shiite maraji’ consider organs to be the property of a person. this is a peculiar position and it raises the question whether the shiite maraji’ consider organs to be the property of a person. if so, why do they conclude that the appertaining property rights do not pass on to a person’s heirs?56 however, if human organs are not considered to be one’s property, the question would arise as to the basis of the fatawa for considering the sale and purchase of organs to be permissible, since the fatawa that have been issued in allowing such sales are based on the rational benefit and worth of such organs. in fact, only two of the maraji’ have 54 haeri, supra note 42. see also montazeri, supra note 41, at 130 (question 289); see also yousuf saanei, http://www.saanei.org/ ?view=01,05,13,49,0 [https://perma.cc/yga4-43te]. (the original sources and their translation are on file with the indiana health law review.). 55 foomani, supra note 32, jarahi, tashrih, va paivand [surgery, autopsy, and transplantation], fatwa no. 1171; sayyid kazim hussaini haeri also mentions that an advance directive to the effect that the decedent’s organs be sold after death is void, haeri, supra note 42. contra mohammad ebrahim jannaati, http://www.jannaati.com/far/ index.php?page=6&row=6&start=42 [http://perma.cc/zjn6-tmh2] (last visited nov. 1, 2015). (the original sources and their translation are on file with the indiana health law review.). 56 for an exploration of the issue see mir sajjad hashemi, supra note 47. 2016 101 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? explicitly stated that humans do not have ownership of their organs as they would of other property, 57 but they may nonetheless transfer their organs in lieu of compensation. these maraji’ have not specified the form and legal qualification of such a transaction. this peculiarity is further complicated by other aspects of the positions of maraji’ that consider the sale and purchase of organs permissible. for instance, in case such a transaction is for any reason void and the donor decides to renege on the transaction, what is to become of the organ? should it be transplanted back to the donor? also, what would be the consequence of not include the necessary contractual safeguards for termination? if a donor were to rescind her offer to “sell” her organ, would she nonetheless be forced to undergo the transplant procedure for failing to incorporate a termination clause in the agreement? one of the maraji’ has been asked to comment on the consequence of a void sale of a human organ and his response has been that the recipient may resell the organ to the donor.58 this is not the consequence of a void sale agreement according to shiite fiqh and the stated position requires further clarification by the marja’. the fact that there is no requirement for a written contract of sale in islamic fiqh and that many consequences of a void sale agreement of a human organ would be left unanswered underscores the need for further thought and deliberation on the nature of human organs and the acceptable form of their transfer to others by the maraji’ that have issued fatawa on these issues. 57 mohammad yaqoobi, a’ttabaro’ bel a’aza [organ donation], http://yaqoobi.com/arabic/index.php/103/126/668.html [https://perma.cc/ yga4-43te ] (last visited jan. 15, 2016); sayyid mahmoud hashemi shahroudi, kharido forooshe a’azaye badan [purchase and sale of organs] http://hashemishahroudi.org/fa/pages/print.php?page= question&id=996 [https://perma.cc/hew7-hq3e ] (last visited jan. 15, 2016). (the original sources and their translation are on file with the indiana health law review.). 58 mohammad ali gerami, masaeli dar babe kharido forooshe a’za [issues on purchase and sale of organs], gerami.org, www.ayatgerami.ir/data.asp?l=1&id=3048 [http://perma.cc/7ffj-d58s] (last visited oct. 16, 2015). (the original sources and their translation are on file with the indiana health law review.). 102 indiana health law review vol. 13:1 iv. the regulation and legal nature of organ transplantation in iran the first kidney transplant in iran was carried out in 1968 using the organ of a live donor and the first cadaveric transplant was performed four years later in 1972. 59 however, the first regulation on transplants was a provision in a byelaw issued in 1976 by the council of ministers in respect of article 42 (3) of the general penal code of 1973.60 according to article 2 of the byelaw, if a medical specialist determined the necessity of an organ transplant, the transplant required obtaining the written consent of the organ donor. furthermore two other specialists had to verify that extracting the organ would not pose a foreseeable physical or mental danger to the donor. 61 this provision was repeated verbatim in a corresponding article in the superseding byelaw of 1978.62 59 history of nephrology in iran, iranian society of nephrology (dec. 2008), http://www.isn-iran.org/mainpage.php?lang=en [http:// perma.cc/496r-8awv] (follow “nephrology in iran” hyperlink; then follow “history” hyperlink). 60 ruznamehi rasmi kishvari shahanshahi iran [the imperial iranian official gazette], aiin nameye ejrai-e band-e 3 madeh-ye 42 ghanoon-e mojazat-e omoomi [implementing byelaw on paragraph 3 of article 42 of the general penal code] oct. 27 1976, no. 9272, available at http://dastour.ir/brows/?lid=93275 [http://perma.cc/z5nm-xgsl]. (the original source and its translation are on file with the indiana health law review.). 61 id. at art. 2. article 42 (3) of the general criminal code provided that any surgical or medical act carried out with the consent of the rightholder and in conformity with regulations adopted and declared by the state is not a crime. ghanoon-e mojazat-e omoomi [general penal code] tehran 1352 [1973] (iran), art. 42. that provision is now reinstated with minor amendments as article 59 (2) of the islamic criminal code. (the original source and its translation are on file with the indiana health law review.). 62 ruznamehi rasmi jumhuri islami iran [the official gazette of the islamic republic of iran], tasvibname darbareye aiin nameye ejrai-e band-e 3 madeh-ye 42 ghanoon-e mojazat-e omoomi [byelaw on the implementing byelaw on paragraph 3 of article 42 of the general penal code] jan. 3 1979, no. 9895 available at http:// dastour.ir/brows/?lid=%20%20%20%20%2098292 [https://perma.cc/ 67cc-2pxd]. (the original source and its translation are on file with the indiana health law review.). http://www.isn-iran.org/mainpage.php?lang=en http://dastour.ir/brows/?lid=93275 2016 103 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? a. compensated live organ donations after the islamic revolution and almost twenty years after the aforesaid regulation, the cabinet issued another byelaw in 1997 simply titled “byelaw on kidney donors” providing for a monetary gift to be paid to kidney donors with the intention of facilitating kidney transplants and encouraging donations.63 according to this byelaw, the sum of ten million (10,000,000) rials shall be granted to kidney donors as reward for their good deed by the foundation for special diseases.”64 this is included in the national budget and paid to the foundation by the executive. 65 hence, although the regulation itself has been passed by the cabinet, the monetary compensation in lieu of organ donations receives the assent of parliament when the budget is approved each year. there are several interesting considerations in this provision. the byelaw only mentions kidney transplants and has not addressed other forms of organ donations that were being carried out even then. also, the amount is granted to the donors as a reward for their altruistic act, commonly known as the “gift of sacrifice.” it is not compensation for the sale and purchase of kidneys, but for the act of donation, or “their good deed.”66 the difference between these two will be explored in more detail below, but it is important to highlight that the iranian legal system differentiates these two 63 ruznamehi rasmi jumhuri islami iran [the official gazette of the islamic republic of iran], byelaw on kidney donors of feb. 25, 1997, no. 15146, available at http://dastour.ir/brows/?lid=165176 [http://perma.cc/n7d7-u6f4] (last visited jan. 15, 2016). (the original source and its translation are on file with the indiana health law review.). 64 id. 65 the charity foundation for special diseases was established in 1996 and is a non-governmental organization that also receives donations from private persons. charity foundation for special diseases, http://www.cffsd.org/about-us [http://perma.cc/ya9u-ykfh](last visited oct. 16, 2015). (the original source and its translation are on file with the indiana health law review.). 66 byelaw on kidney donors, supra note 63. http://dastour.ir/brows/?lid=165176 104 indiana health law review vol. 13:1 transactions and the regulated scheme for compensation is not one of human organ purchase and sale. the amount provided in the byelaw was over forty-eight times higher than the monthly minimum wage at that time. hence, it provided a significant financial incentive to donors, and thereby effectively overcame the kidney shortage prevalent at the time. however, this amount has remained unchanged over the years, despite the monthly minimum wage having had a twentyfold increase.67 even if the rather conservative and cautious rates of inflation declared by the central bank of iran for the past fifteen years are not factored in the equation, 68 the amount that would be commensurate with the original provision’s ratio to minimum wage should be considerably higher today, standing close to two hundred and ninety four million (293,855,140) rials. the fact that no change has been made to the “gift of sacrifice” has caused potential donors to seek compensation elsewhere, by advertising their readiness to “sell” their kidneys to those who need one and are willing to pay the price requested by the donors. 67 see khabaronline, negahi be hadeaghal dastmozd taye 34 sale gozashte: faseleye hadeaghale dastmozd va nerkhe tavarom cheghadr ast? [a look at the minimum wage over the past 34 years: what is the gap between the minimum wage and the rate of inflation?] www.khabaronline.ir/print/275142/economy/macroeconomics [http:// perma.cc/w7bz-fp53] (last visited jan. 15, 2016) (showing data published by the central bank of iran that minimum wage was 207,210 rials in 1997 and 3,900,000 rials in 2012). minimum wage was 608 dollars, alef.ir, http://alef.ir/vdcbw9b59rhb8sp.uiur.html?219589 [http://perma.cc/738c-3nyw] (last visited oct. 16, 2015) (showing that in both 2013 and 2014 the minimum wage was again increased and now stands at just over 6,089,000 rials). (the original sources and their translations are on file with the indiana health law review.). 68 see the real rate of inflation is above 50%, tabnak (oct. 16, 2012), www.tabnak.ir/fa/print/279113 [http://perma.cc/8ejr-dleb] (showing that the rate of inflation declared by the central bank of iran (cbi) is often disputed: while average inflation for 2012-13 has been estimated at under 30 percent by the cbi, some estimates put this at over 50% or higher, going up as much as 196%). see also growth of 97% inflation in 20 months, alef.ir (jan. 6, 2013, 11:17 am), http://alef.ir/ vdchimnzx23nqid.tft2.html?175223 [http://perma.cc/8ubh-kpgz] (giving an average inflation for the months of march 2011 to november 2012 estimated at 97%). (the original source and its translation are on file with the indiana health law review.). http://www.khabaronline.ir/print/275142/economy/macroeconomics 2016 105 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? the directive on kidney donations and transplants from live donors issued in 2008 by the ministry of health69 is also worthy of mention here. this directive sets out the regulations for live donations in five sections: 1) the criteria for live unrelated donors; 2) medical tests and examinations prior to donation; 3) transplants for foreign nationals; 4) other provisions; and 5) monitoring.70 section one of the directive sets forth several factors for living unrelated donors, including age (between the age of 1845, and over 25 for unmarried female donors), informed written consents by the donor and the donor’s spouse (if married) or parents (if single), nationality, “thorough medical examinations and tests” to be carried out by specialized medical doctors which are further stipulated under section two of the directive and detailed in relevant protocols. furthermore, this section absolutely bars habitual intravenous drug users from donating their kidneys.71 these provisions do not stipulate a definition of “unrelated donors” or a method of verifying such status. this loophole is an oversight that is conducive to dealings whereby parties may claim to be related, thereby “selling” their organs on the market and foregoing the reward foreseen in the regulatory framework altogether, which is currently of little to no value. in addition to the provision in section one of the directive requiring the donor and recipient to be nationals of the same state, section three provides further provisions to ban transplants between people of different nationalities.72 this section states that transplants for non-iranians may only 69 dastoor-ol amal-e ehda va paivand kollieh az ehda konandegane zendeh [directive on kidney donations and transplants from live donors] of 20 october 2008, [hereinafter directive on kidney donations and transplants from live donors] available at http://www.behdasht.gov.ir/index.aspx?siteid=1&pageid=13401&newsvi ew=5813 [https://perma.cc/ bdm9-aqdu]. the directive was prepared through a collaborative undertaking by the following: academy of medical sciences, iranian society of organ transplantation, transplantation and dialysis council, medical ethics research center of tehran university of medical sciences, and the legal department of the ministry of health and medical education. (the original source and its translation are on file with the indiana health law review.). 70 id. 71 id. § 1(5). 72 id. 106 indiana health law review vol. 13:1 take place between those who are nationals of the same state.73 the only exception is that of married couples who may have different nationalities.74 by virtue of this section, transplants for all foreign nationals requires specific written license. furthermore, according to a separate byelaw issued on the subject of transplants for foreign nationals, such license may only be given by the center for dialysis and organ transplants of iran. the license must be in writing and issued upon satisfaction of the relevant criteria for transplants for foreign nationals.75 under section four of the directive, any organized coordination with the purpose of organ donations by iranians in other states has been prohibited. 76 this section also prohibits any advertising or notice for donation and threatens legal action for any violations by those who place or publish a notice or advertisement for requesting an organ.77 it further prohibits any brokerage or trade in the process of kidney donations from live donors. monitoring these regulations has been entrusted to the “experts of the department of transplants and special diseases of the ministry of health” and “the experts of medical sciences universities across the nation”, the sanction for violations being the complete shutdown of the transplant ward.78 b. cadaveric organ transplants separate regulations govern the transplant of cadaveric organs. regulating cadaveric organ transplants in iran has not been an easy task due to the religious obstacles involved. however, with the issuance of fatawa on the matter, the parliament of iran enacted a law on april 5, 2000 entitled: 73 id. § 3(1) 74 id. § 3(2) 75 vct.kmu.ac.ir, a’in nameye payvande kollieye atba’e khareji [organ transplant of foreign nationals byelaw], http://vct.kmu.ac.ir/ images/userupload/document/vct/darman/aeen%20name.pdf [https:// perma.cc/s9jx-z4ta ] (last visited jan. 15, 2016). (the original source and its translation are on file with the indiana health law review.). 76 directive on kidney donations and transplants from live donors, supra note 69, § 4(3). 77 id. § 4(1). 78 id. § 5. 2016 107 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? “transplant of organs from deceased patients or patients with evident brain death” (hereafter the brain death law or bdl).79 the law was neither approved nor rejected by the guardian council and thus entered into force in accordance with article 94 of the constitution.80 furthermore, a byelaw issued on the 18th of june 2001 was issued to complement the bdl.81 the bdl provides that equipped hospitals may use the healthy organs of deceased patients, or patients who have been ascertained to be brain dead by experts, for transplanting to patients whose life depend on the organ(s).82 this is subject to the deceased or brain dead patients’ will and testament, or the consent of their heirs. it also requires the hospital to have obtained written authorization from the ministry of health for this purpose.83 several points are noteworthy. the question of consent has been highlighted in the bdl and further elaborated in the bdl byelaw. the donor may have declared consent orally 79 law on the transplant of organs from deceased patients or patients with evident brain death of 5 apr. 2000 (iran), [hereinafter law on the transplant of organs from deceased patients] available at dastour.ir/print/?lid=188843 [https://perma.cc/km2m-wmcd]. (the original source and its translation are on file with the indiana health law review.). 80 islahat va taqyyrati va tatmimah qanuni assassi [amendment to the constitution] 1368 [1989], art. 94 (iran). article 94 states that: “[a]ll legislation passed by the islamic consultative assembly must be sent to the guardian council. the guardian council must review it within a maximum of ten days from its receipt with a view to ensuring its compatibility with the criteria of islam and the constitution. if it finds the legislation incompatible, it will return it to the assembly for review. otherwise the legislation will be deemed enforceable.” 81 implementing byelaw for the law on the transplant of organs from deceased patients or patients with evident brain death of 18 june 2001 [hereinafter implementing byelaw] available at http://dastour.ir/brows/?lid=258228 [https://perma.cc/ z2hx-23w2] (last visited oct. 16, 2015). see also dastour.ir, http://dastour.ir/brows/?lid=260706 [https://perma.cc/smj4-c6qq ] (last visited oct. 16, 2015) (detailing a minor amendment to the bdl byelaw that was made on 4 september 2002). (the original source and its translation are on file with the indiana health law review.). 82 directive on kidney donations and transplants from live donors, supra note 76, § 5. 83 id. 108 indiana health law review vol. 13:1 or in writing prior to death, or the heirs may provide consent post mortem. the heirs or “wali” is defined in the bdl byelaw based on descent and distribution provisions of the civil code. 84 where the decedent donor has given consent orally prior to death, consent may be evidenced by a written declaration of a single legal heir. 85 also, if the written consent of the deceased is not readily available, any legal heir who is certain of the will of the deceased to donate may sign a declaration and testify to that effect.86 experts who are authorized to determine brain death are appointed by the ministry for a period of four years and stationed in equipped public university hospitals, their determination of brain death must be based on a protocol prepared by the ministry,87 and they cannot be members of a transplant team.88 the bdl byelaw provides that these experts must consist of four medical doctors specializing in neurology, neurosurgery, internal medicine, and 84 see qanuni madani [civil code] tehran 1314 [1935], art. 862 (iran). article 7 of the bdl byelaw has departed from the definition of wali under article 1180 et seq. of the civil code and has defined this according to the provisions on inheritance. the byelaw defines the wali of the deceased as legally adult heirs who can consent to the organ transplant. see also id., art. 862 (defining heirs as: 1 – father and mother and children, and grandchildren; 2 grandparents, brother and sister and their children; 3 paternal uncles and paternal aunts, maternal uncles and maternal aunts and their children). see also id. art. 864 (defining the spouse of a deceased person as an heir by cause of marriage). cf. qanuni mojazate eslami [islamic penal code] tehran 1370 [1991], art. 261 available at http://dastour.ir/print/?lid=143178 [https:// perma.cc/a224-zrrf ] (also defining the wali as heirs of the decedent, except that the bdl byelaw is inclusive of the spouse of the deceased and it requires the written consent of all heirs, meaning those who would be first in line as descendants for the purpose of inheritance). (the original sources and their translations are on file with the indiana health law review.). 85 implementing byelaw, supra note 81, art. 6. 86 id. 87 see protocol-e taiin-e marg-e maghzi [protocol on the determination of brain death], ass’n of organ donation supporters, http://www.nafase-javid.ir/showthread.php?tid=71 [https://perma.cc/yl39-akvn] (last visited jan. 16, 2016). (the original source and its translation are on file with the indiana health law review.). 88 law on the transplant of organs from deceased patients, supra note 79; implementing byelaw, supra note 81 arts. 2 & 3. 2016 109 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? anesthesiology.89 their examination of the patient must take place independently of the others and if their determination is unanimous, an expert in legal medicine shall verify their determination.90 while the bdl does not provide a definition of brain death, article one of the bdl byelaw defines this as the “complete and irreversible cessation of all cortical, subcortical and brain stem activity.”91 the various tests for this determination have been set out in the protocol. this provides practical finality to the differing fatawa on the matter and establishes a legal frame of reference on the question of brain death. furthermore, an explanatory note issued by the legal department of the judiciary on 12 may 2008 states that brain death is synonymous with death and entails all legal consequences of death.92 last but not least, no compensation has been allowed in the regulations for the donation of cadaveric organs. in addition to the fatawa holding that no compensation may be made for consenting to the use of cadaveric organs by the heirs of the deceased, the websites of the various transplant authorities in iran have also mentioned this restriction.93 c. the legal nature of compensated live organ donation the legal nature of donations under the current regulations of iran must be assessed against the background of the more general provisions of the iranian legal system, particularly the civil code. the code, modeled after the french code civil and drawing upon islamic fiqh of the twelver persuasion, has differentiated between various kinds of contracts. article 10 of the code recognizes the 89 implementing byelaw, supra note 81, art. 2. 90 id. arts. 2 & 3. 91 implementing byelaw, supra note 81, art. 1. 92 opinion number 7/1004, may 12, 2008, available at http:// dastour.ir/brows/?lid=335364. (the original source and its translation are on file with the indiana health law review.). 93 see, e.g., ehda.ir, http://ehda.sbmu.ac.ir/?fkeyid=&siteid= 489&pageid=34591[https://perma.cc/3c8p-uhnq] (last visited jan. 17, 2016). (the original source and its translation are on file with the indiana health law review.). 110 indiana health law review vol. 13:1 general freedom to contract, 94 and rules governing the general law of contracts and obligations have been set forth in various provisions. a number of specific types of contracts have been addressed and subjected to separate rules, each type of contract having a special regime. it has already been clarified that no compensation is due for cadaveric organs and that the byelaw on kidney donors of 1997 has only established a framework for compensated live organ donation as described above. the legal nature of this undertaking is best characterized as a contract of reward95 or ju’alah, as defined by article 561 of the civil code as engaging a person to make a payment in exchange for an act even if the other party is not known. this provision provides the possibility of compensating any act that is not illegal or unreasonable.96 this latter condition should be read in tandem with the general provision for the object of transactions under the civil code, whereby the object of a contract must be valuable and provide for a “reasonable and legitimate advantage.” 97 as noted previously, the transfer of organs was traditionally considered to lack a reasonable and legitimate advantage. however, with the possibility of transplanting organs to save lives and restore health, the numerous fatawa issued by the most senior maraji’, and the resultant laws and regulations on transplants, there is no question as to the reasonable advantages of such transactions or to their legality. the contract of reward may be offered to a specific person or the general public, thereby permitting the public tender of an act such as kidney donation. furthermore, a contract of 94 qanuni madani [civil code] tehran 1314 [1935], art. 10. article 10 provides that: “private contracts shall be binding on those who have signed them, providing they are not contrary to the explicit provisions of a law.” (the original source and its translation are on file with the indiana health law review.). 95 see muhammad ayub, understanding islamic finance, 351 (2009); see also muhammad yusuf saleem, islamic commercial law, 61-64 (2013) (for a general explanation of this type of contract in islamic law). 96 qanuni madani [civil code] tehran 1314 [1935], art. 570 (iran). (the original source and its translation are on file with the indiana health law review.). 97 id. at art. 215. 2016 111 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? reward creates an obligation of result for the agent98 and is a voidable contract. article 565 of the civil code provides that either party in a contract of reward [ju’alah] may withdraw because the contract is permissive.99 if the person paying the reward terminates the contract while the act is being carried out, the agent must still be compensated reasonably for the act.100 this ensures that the organ donor may terminate the undertaking at any time, thereby safeguarding the donor’s consent. this is exactly the legal qualification of the byelaw of 1997, where the state has offered a certain sum of money as a reward to whosoever may donate their kidney. 101 the protocols in place protect the consent of donors by ensuring that they may rescind their decision to donate at any time. the compensation for donation is provided to the donors only after the transplant takes place. therefore, the official compensated scheme for human organ transplants only applies to live donors and is a reward for the act of donation, not the sale and purchase of kidneys. v. ambiguous transactions and absurd consequences a particular ambiguity exists with respect to the current agreements reached by individuals outside the official framework described above. as was noted, the compensation provided by the state has not been increased over the years and has lost any meaning as an incentive. the result is that notices are now illegally posted on websites or the walls and adjacent streets of transplant centers whereby offers are made to “purchase” kidneys of particular blood types needed by potential recipients.102 this raises an important question: if such transactions take place between private parties, what would be the legal qualification of the transaction? this is further complicated by the numerous fatawa that have authorized the sale and purchase of organs. the lack of an express prohibition on the sale of human organs in iranian 98 id. at art. 567. 99 id. at art. 565. 100 id. 101 byelaw on kidney donors supra note 63. 102 dehghan, supra note 10. 112 indiana health law review vol. 13:1 law and the possibility of resorting to fatawa by virtue of article 3 of the civil procedure code in certain cases 103 further complicates the issue. the said article, with the intent to prevent a non liquet, provides: justices of the courts [judges of the courts] shall adjudicate claims, issue judgments, and settle disputes based on law. if positive [posited] laws are incomprehensive or unspecific or contradictory or non-existent in the case in question, they shall issue their ruling of the case by reference to reputable islamic sources or reputable fatawa and legal principles that don’t contradict the criteria of shari'a, and they may not refrain from hearing claims and issuing judgments due to the silence or deficiency or brevity or contradiction of the law, else they shall be held to be in denial of justice and convicted accordingly. noteif a judge is a mujtahid and considers the law to be in violation of shari'a, the case shall be referred to another chamber for adjudication.104 of course this provision in and of itself may not result in uniform jurisprudence on issues that are inadequately regulated. the iranian judicial system is based on the french civil law system, and the sole authority capable of creating uniform judicial practice in iran is the supreme court. therefore, courts of first instance and of equal standing do not have to abide by each other’s decisions. in view of the various approaches in the fatawa on human organ donation, particularly the legal qualification of such donations, it will ultimately fall on the supreme court to decide on divergent judgments from the lower courts on issues such as the sale and purchase of organs. however, the question remains that in view of the silence of the law, would a judge who is confronted by a claim of organ purchase with the intent to transplant, rule in favor of the “purchaser” and force the “seller” to undergo a transplant operation? alternatively, would the court order compensation for breach of contract instead of specific performance? this is particularly important in that the majority of fatawa do not 103 aini dadrassii madani [civil procedure code] tehran 1379 [2000] art. 3 (iran) (the original source and its translation are on file with the indiana health law review.). 104 id. 2016 113 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? seem to have taken into account the wider policy implications of the possibility for the sale and purchase of organs. the advisory opinions issued by the legal bureau of the judiciary 105 (the bureau) are also indicative of a legal conundrum on this question. the bureau appears to be unable to decide on the legal nature of the donation of organs. in an advisory opinion106 issued in 2005 and citing the bdl, it has declared that the sale or donation of organs for transplants is permissible, but appears to be at a loss as to what consequences may arise if the heirs of a decedent who has “sold” or donated her organs reject the procurement procedure.107 the bureau, somewhat befuddled, states that apart from filing a civil action against the heirs to fulfill the obligation of the decedent, no other recourse appears to be available.108 the bureau has also used the term “sale” in another of its opinions,109 surprisingly by reference to the bdl, which makes no reference to the legal qualification of the transfer of cadaveric organs. it declares that the sale and purchase of human organs is illegal except in the framework of the bdl and its byelaws. this position of the bureau is particularly interesting in that it also contradicts many of the fatawa on the donation of cadaveric organs. the bureau appears to consider the bdl as an exception to a general prohibition of organ extractions and, in fact, uses the term “donation” of organs in other opinions and insists that the act of donation should not contravene human 105 this bureau is part of iran’s judicial structure. among other things, it is tasked with providing advisory opinions on judicial matters and publication of these opinions for reference by the courts. however, its opinions are not binding and even the website of the bureau has a disclaimer to the effect that the advisory opinions do not necessarily reflect the official positions of the judiciary. see legal bureau of the judiciary, http://www.edarehoquqy.ir/ [http://perma.cc/8zx8-qnq3]. (the original source and its translation are on file with the indiana health law review.). 106 opinion number 7/7712, january 3, 2005, file no. 83-30-1770. (the original source and its translation are on file with the indiana health law review.). 107 id. 108 id. ¶ 2. 109 opinion number 7/770, apr. 29, 2009, file no. 88-30-47. (the original source and its translation are on file with the indiana health law review.). http://www.edarehoquqy.ir/ 114 indiana health law review vol. 13:1 dignity, 110 and is mindful of humanitarian and ethical considerations. 111 another widely cited opinion of the bureau that has also been referenced by the monthly publication dadrasi, has stated that human organs cannot be sold because they are not property, but an individual may donate them to others when alive or after death and receive compensation.112 in view of the foregoing and the fact that the supreme court has not yet issued a judgment on the matter, it is uncertain how the courts in iran would handle a case of organ sale. on the one hand, the general freedom of contract and the silence of the law on the sale of human organs, coupled with the fatawa that are permissive of such sales, may be considered to provide license for the sale of human organs. if so, the courts would have to enforce an agreement for the sale, either issuing a judgment reminiscent of shakespeare’s merchant of venice to the effect that the seller should check into a transplant center and have his or her organ removed and surrendered to the purchaser, or ordering compensation for breach of contract. this conclusion may also appear to be supported by reference to the provisions of the iranian civil code on sales, which in article 339 provides that a sale is concluded by offer and acceptance without requiring a written contract.113 the code goes on to provide in article 362 that upon such conclusion, the buyer becomes the owner of the object of sale and the seller is responsible for surrendering the object of sale to the buyer.114 furthermore, contrary to a contract of 110 opinion number 7/4067, oct. 2, 2010. (the original source and its translation are on file with the indiana health law review.). 111 opinion number 7/5077, oct. 10, 2005, file no. 84-30-172. (the original source and its translation are on file with the indiana health law review.). 112 markaze tahghighate fiqhi-e ghoveye ghazaie [the fiqh research center of the judiciary], estefta’ate fiqhi-ghazaii (dar omoore hoghooghi) [judicial/islamic opinions (on civil matters)], 43 dadrasi journal, 44, 45 (2004), (referencing opinion number 7/1558, sept. 24, 1997). (the original source and its translation are on file with the indiana health law review.). 113 qanuni madani [civil code] tehran 1314 [1935], art. 339 (iran). (the original source and its translation are on file with the indiana health law review.). 114 id. at art. 362 (iran). 2016 115 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? reward, a contract of sale is not a voidable contract and failing an agreement by both parties to revoke, or in case the various reasons for termination under the civil code115 are not met or stipulated, including the right of termination without cause,116 it appears that the bureau is right in that the buyer may file a civil action for breach of contract. this conclusion, however apart from being counterintuitive and contrary to the iranian juris-culture,117 necessitates certain assumptions and entails particular consequences that are not justified under the iranian legal system. of particular importance here is the possibility of ownership of the human body in general or human organs in particular. the fatawa that are permissive of selling human organs are based on the premise that such organs are of value and may therefore be the subject of transactions; but, save for a few, they have not addressed the separate question of ownership of the human body or organs in this context. the assumption of the possibility of owning a part of another human being, which would be the result of accepting human organ sales by virtue of article 140 of the civil code118 and relevant provisions cited above, would result in slavery or slavery-like practices which have been illegal in iran by virtue of international treaties signed119 and ratified 115 id. at arts. 396 et seq (iran). 116 id. at arts. 399-401 (iran). 117 apart from the ambivalence of the bureau, the current practice of authorities such as public notaries, courts, and organ procurement centers does not seem to support this conclusion. a widely cited note by the secretary of the civil laws commission of the supreme council for judicial development, dr. ali abbas hayati, also rejects this conclusion. see ali abbas hayati, mabnaye hoghooghie ehda va paivande a’zaye badan [the legal basis of donation and transplant of organs], 156 farhango pajouhesh 12 (2004) (iran). (the original source and its translation are on file with the indiana health law review.). 118 section 2 of this article stipulates that contracts and obligations are a cause of ownership, and one of the most prominent examples of transfer of ownership is the contract of sale, which as discussed above, is a cause of immediate transfer of ownership from seller to buyer under iranian law. qanuni madani [civil code] tehran 1314 [1935], art. 140 (iran). (the original source and its translation are on file with the indiana health law review.). 119 slavery convention of 1926, art. 1, sept. 25, 1926, 60 l.n.t.s. 253. slavery is defined as “…the status or condition of a person over 116 indiana health law review vol. 13:1 by iran, 120 and iranian national legislation. 121 the assumption of owning another human being’s organ(s) would empower the purchaser to unlimited and unrestricted exploitation and use, and the establishment of a right of ownership and claim to a part of another person.122 the consequences of assuming ownership of the human body would also be absurd and would involve numerous questions too detailed and varied to cover in this paper. these include issues such as the possibility of transfer of ownership of the organ by the purchaser to another buyer, possibly for a profit; the matter of inheriting organs by heirs of the purchaser and devolution of ownership rights to third parties by reason of a decedent buyer’s will and testament; and the possibility of a criminal charge for crime(s) committed against property, possibly by the organ donor. taken together, these considerations make it extremely unlikely that a court would uphold a claim for compensation due to breach of contract, the subject of which is the sale of human organs. on the possibility of requesting specific performance by the donor, it is worthy to note that lex specialis derogat legi generali: special laws will have precedence over general legislation where they exist. if in the unlikely scenario, even as a thought experiment, a court were to render a judgment in favor of a claimant and order the surrender of the organ whom any or all of the powers attaching to the right of ownership are exercised.” 120 supplementary convention on the abolition of slavery, the slave trade, and institutions and practices similar to slavery, art. 7, sept. 7, 1956, 226 u.n.t.s. 3. article 7(a) of this treaty provides: “slavery" means, as defined in the slavery convention of 1926, the status or condition of a person over whom any or all of the powers attaching to the right of ownership are exercised, and "slave" means a person in such condition or status.” 121 this national legislation includes the prohibition of slavery. qanuni man’e kharido forooshe barde dar khake iran va azadi barde dar moghe’e vorood be mamlekat [prohibition of the purchase and sale of slaves in iranian territory and freedom of slaves upon entry to the country], tehran 1307 [1929], iran. (the original source and its translation are on file with the indiana health law review.). 122 qanuni madani [civil code] tehran 1314 [1935], art. 30 (iran). (the original source and its translation are on file with the indiana health law review.). 2016 117 human organ donations under the “iranian model”: a rewarding scheme for u.s. regulatory reform? by the “seller,” it is unimaginable how the operation would take place. iranian criminal laws are replete with provisions on the inviolability of the human body, including post mortem.123 particular medical law and regulations124 are also prohibitive of any surgical procedure without the written authorization of the patient, and the particular requirement for establishing the consent of organ donors for organ transplants procedures has already been covered. it is unimaginable that a transplant center would undertake a transplant operation without the consent of the donor and risk civil action and criminal charges. in view of the above, it is safe to assume that should a case be brought to court requesting the enforcement of a “sale” of a particular organ, the court will either treat it as an agreement for donating an organ under a contract of reward (ju’alah) and respect the will and consent of the donor in revoking the agreement, or reject the submissions of the claimant as violating public order.125 until such time that such cases are taken to court however, it will not be absolutely clear what direction the courts or the supreme court will take. vi. conclusion any state that decides to provide some form of financial incentive for organ donation should also provide safeguards against the rather dramatic realization of the shakespearean scene from the merchant of venice and fully protect the dignity and consent of donors. the iranian model of organ transplantation appears to have been somewhat successful in preventing such an outcome. contrary to popular belief that the iranian model of organ donation is one of organ sales, by virtue of the particular legal concept of reward or 123 qanuni mojazate eslami [islamic penal code] tehran 1370 [1991], art. 494 (iran). 124 see manshoore hoghughe bimar dar iran [charter on patients’ rights in iran] tehran, 1388 [2009], art. 3 (iran), available at mehr.tums.ac.ir/showlaw.aspx?lawid=46 [https://perma.cc/8fnhk5mu]. 125 aini dadrassii madani [civil procedure code] tehran 1379 [2000] art. 6 (iran). (the original source and its translation are on file with the indiana health law review.). 118 indiana health law review vol. 13:1 ju’alah under iranian law that governs the act of donation and by the establishment of structural safeguards, iran has managed to provide a compensated incentive to donors without objectifying them or their organs. the prohibition of transplant tourism, ensuring that donors receive free healthcare, provision of free psychological and vocational evaluations and consultations to donors further ensures their welfare. this particular legal regime of organ donations, coupled with the particular provisions of iranian regulations on live and cadaveric donations, has managed to overcome the organ shortage in iran and save thousands of lives. however, much may be said of the fact that many live unrelated donors are undergoing transplant procedures for reason of economic hardship. such financial distress is a major impediment to the equitable application of the principles of justice and autonomy to donors, but needs to be addressed in the wider context of socio-economic considerations of a nation’s healthcare system. the fact of back-alley deals between donors and recipients in iran is a major concern that needs immediate attention, possibly by adjusting the reward for organ donors to meet the true inflation rate in iran and tightening the loopholes in current regulations, obviating the need and possibility for donors to conclude transactions with recipients outside the official transplant framework. despite these flaws and shortcomings, the fact is that the overall approach of the iranian model may prove beneficial to reforming the current policy and regulations on human organ transplants in the united states and overcoming the organ shortage that is causing the death of thousands of patients on waiting lists every year. the notion of buying or selling human organs understandably causes pause for most people, if not outright aversion or disgust. however, rewarding the act of saving another person’s life is a wellestablished and welcome approach. the question of compensating organ donors should not be addressed within a discourse of “purchase and sale of human organs,” but of “rewarding the act of saving a fellow human being’s life,” even if such reward may include monetary compensation. microsoft word 1-volume xii masthead.docx combating obesity one step at a time: why indiana should implement statewide complete streets legislation samantha r. chapman* i. introduction .................................................................. 385 ii. background .................................................................. 389 a. the issue: the growing statewide obesity rate ..... 389 b. complete streets outside indiana ............................ 396 c. complete streets across indiana .............................. 399 d. the empirical evidence base for built environment and complete streets ...................................................... 402 e. additional benefits of enacting complete streets legislation ....................................................................... 410 iii. analysis of complete streets to combat hoosier obesity ............................................................................... 412 iv. conclusion .................................................................. 421 i. introduction the nation is encountering an epidemic. an epidemic whose numbers continue to rise despite national and statewide efforts to curb its detrimental effects on american society. indiana is not unaffected by this epidemic. research shows that indiana is one of the states hit hardest, as the rate of obesity remains stagnant, just like those affected by it. although the solution may seem simple, people need to eat less and exercise more; obesity proves to be a much more complex, multi-factored social and medical problem. obesity is a growing problem across the nation, especially in the south and midwest regions of the united states.1 today, about two-thirds of americans are * j.d. candidate, 2015, indiana university robert h. mckinney school of law; b.s., 2012, manchester college. http://dx.doi.org/10.18060/18966 386 indiana health law review vol. 12:1 overweight and about one third are obese.2 this is such an alarming issue that the surgeon general asserted that today’s youth may be the first generation not to outlive their parents.3 in 2012, the centers for disease control and prevention (“cdc”) released a study concluding that nearly 30% of indiana adults are obese.4 indiana has the eighth highest obesity rate in the united states compared to last year’s ranking of fifteenth.5 to combat this problem, the cdc provided indiana along with many other states federal funds to implement a plan to reduce the alarming statistics. the indiana healthy weight initiative provides hoosiers with a plan for prevention including information on: childcare and preschool, schools k-12, worksites, healthcare, food environment, built environment, aging population, and breastfeeding.6 the built environment aspect of the indiana healthy weight initiative seeks to facilitate changes to the built environment that support increased levels of physical activity.7 built environment is defined as all of the physical parts of where we live.8 this includes homes, buildings, streets, open spaces, and infrastructure.9 decreased levels 1 barb berggoetz, indiana’s adult obesity rate climbs to 8th worst in u.s., the indianapolis star (aug. 13. 2012, 9:28 pm), http://www.indystar.com/article/20120813/news/120813016/indiana-sadult-obesity-rate-climbs-8th-worst-u-s-. 2 julie wakefield, fighting obesity through the built environment, env’t health perspectives (aug. 2004), http://www.ncbi.nlm.nih.gov/pmc/articles/pmc1247493. 3 id. 4 nat’l ctr. for chronic disease prevention and health promotion, overweight & obesity: indiana state nutrition, physical activity, and obesity profile (2012), available at http://www.cdc.gov/obesity/stateprograms/fundedstates/pdf/indianastate-profile.pdf. 5 berggoetz, supra note 1. 6 new and noteworthy, ind. healthy weight initiative, www.inhealthyweight.org/97.htm (last visited oct. 7, 2013). 7 id. 8 impact of the built environment on health, centers for disease control and prevention (june 2011), http://www.cdc.gov/nceh/publications/factsheets/impactofthebuiltenviron mentonhealth.pdf 9 id. 2015 combating obesity one step at a time 387 of activity are supported when sidewalks and biking paths are inaccessible or non-existent to people in communities.10 the main built environment policy that the indiana healthy weight initiative supports is called “complete streets.” complete streets are designed and operated to enable safe access for all users: pedestrians, bicyclists, motorists, and public transportation users of all ages and abilities are able to safely move along and across a complete street.11 complete streets has become a national movement to ensure that transportation planners and engineers consistently design and operate the entire roadway with all users in mind.12 leaving streets incomplete means that many people will lack the ability to be active in their daily lives and instead requires people to drive to the places they need to go within the community. the likelihood of obesity rises with increased amount of time spent in the car per day, according to lawrence frank, an associate professor of community and regional planning at the university of british columbia.13 every thirty additional minutes spent in a car was linked to a 3% increase in obesity in a recent study of 11,000 residents in atlanta, georgia.14 although obesity is a multifaceted health issue, complicated by genetic and environmental interactions, the rapid increase in obesity in the last thirty years suggests that largely environmental factors are responsible for this trend.15 samuel wilson, deputy director of the national institute of environmental health sciences agreed. “our built environment promotes a sedentary lifestyle today” and “…if we better understand the linkages between obesity and the built environment, we can create communities and 10 id. 11 indiana complete streets coalition, health by design, http://www.healthbydesignonline.org/indianacompletestreetscampaign .html (last visited aug. 20, 2014). 12 complete streets, cal. bicycle coalition, www.calbike.org/ advocacy/complete-streets/ (last visited aug. 20, 2014). 13 wakefield, supra note 2. 14 id. 15 id. 388 indiana health law review vol. 12:1 workplaces that promote health and also promote wellbeing, an important feature in overall health.”16 some indiana communities have determined that complete streets are the answer for improving community connectedness along with promoting physical activity among its members. bloomington, madison county, lake/porter county, columbus, richmond, evansville, frankfort, tippecanoe county, indianapolis, and westfield have all adopted complete streets policies between 2009 and 2012.17 although these local ordinances and resolutions are a step in the right direction, indiana cannot even begin to make a dent in the state’s alarming obesity rate without enacting statewide complete streets legislation. other states that have implemented statewide complete streets legislation have seen positive outcomes relating to increases in physical activity, along with more connected communities. leaders and citizens in indiana must band together to support a uniform policy that will address making streets more complete, so that hoosiers may have the opportunity to stay physically active in their daily lives. if statewide complete streets legislation fails yet again in the general assembly, hoosiers will likely continue to see an increase in their waistlines along with health care costs related to obesity. first, this note will discuss the issue of obesity and how the epidemic had worsened in the last decade, the health care costs associated with obesity, and specifically the negative health effects that weigh down society. next, current complete street policies both outside and inside of indiana will be examined and evaluated for effectiveness. empirical evidence on the relationship between obesity and built environment will also be reviewed. statewide complete streets legislation will be examined as a way to improve the state’s physical activity rate by providing streets where pedestrians, bicyclists, motorists, and public transportation users feel safe to travel. the history of how these policies have been adopted will also be addressed. finally, this note will focus on the ways in which indiana 16 id. 17 indiana complete streets coalition, supra note 11. 2015 combating obesity one step at a time 389 could benefit from implementing statewide complete streets legislation to combat the high state obesity rate by increasing physical activity, along with various other aspects of hoosier health. ii. background a. the issue: the growing statewide obesity rate obesity is defined by the centers for disease control and prevention (“cdc”) as a weight that is greater than what is generally considered healthy for a person of a certain height.18 determining if an individual is overweight or obese occurs by calculating his or her body mass index (“bmi”). bmi is used as an indicator because it correlates with a person’s amount of body fat.19 in 2012, the cdc released a study indicating that among indiana adults over eighteen years of age, 65.9% of adults were overweight with a bmi of over twenty-five and 29.6% of adults were obese with a bmi of over thirty.20 among indiana adolescents, enrolled in grades nine through twelve, 15.9% were overweight and 12.8% were obese.21 among indiana children, ages two to five, 16.6% were overweight and 14.2% were obese.22 this amounts to over 1.5 million hoosiers being classified as obese.23 in regard to physical activity, the study found that 27.2% of adults had not participated in any physical activity in the past month and only 43.2% of adults had achieved at least 300 minutes per week moderate intensity physical activity or 150 18 defining overweight and obesity, centers for disease control & prevention, http://www.cdc.gov/obesity/adult/defining.html (last visited aug. 20, 2014). 19 id. 20 nat’l ctr. for chronic disease prevention and health promotion, supra note 4. 21 id. 22 id. 23 united health found., state data > indiana, america’s health rankings, http://www.americashealthrankings.org/in (last visited aug. 22, 2014). 390 indiana health law review vol. 12:1 minutes per week of vigorous-intensity physical activity.24 overall, one in four indiana adults remain inactive.25 obesity is a condition correlated with genetics and a person’s environment. thirty to forty percent of obesity can be attributed to an individual’s genes.26 other factors include diet and energy intake, physical activity, and individual factors.27 according to f as in fat: how obesity threatens america’s future 2013, a report from the trust for america’s health and the robert wood johnson foundation, region, age, gender, education, and income are also factors associated with obesity.28 the report notes that individuals living in the south and midwest regions of the united states, older individuals, less educated individuals, and individuals with lower incomes have a higher likelihood of being obese.29 physicians recommend a variety of treatment options including: diet, physical activity, behavior modification, medications, and sometimes even surgery in situations where other treatment methods are ineffective.30 each treatment plan must be individually constructed, as people face different obstacles in the weight loss process. obesity is linked to heart disease, stroke, diabetes, some cancers, and countless other health problems.31 the indiana state department of health released, “the burden of obesity related cancers and the promotion of physical 24 nat’l ctr. for chronic disease prevention and health promotion, supra note 4. 25 united health found., supra note 23. 26 donald d. hensrud, the obesity explosion: how did we get here and where are we at? (2013), available at http://kelley.iu.edu/cbls/files/conferences/hensrud%20obesity%20indi ana%2011-22%20final.pdf. 27 id. 28 f as in fat: how obesity threatens america’s future 2013, trust for america’s health, http://healthyamericans.org/report/108/ (last visited feb. 28, 2014). 29 id. 30 id. 31 nat’l ctr. for chronic disease prevention and health promotion, supra note 4. 2015 combating obesity one step at a time 391 activity in indiana” in 2014.32 the report identified that not only is obesity an issue in indiana, but it is also causing higher rates of cancer for hoosiers.33 estimates suggest that being overweight or obese contributes to 14-20% of all cancer-related mortality.34 the most prevalent cancers related to excess weight include: postmenopausal breast, colon and rectum, endometrial, esophagus, gallbladder, thyroid, kidney, and pancreatic.35 the incidence rates of esophageal, pancreatic, kidney and renal, and thyroid cancer have significantly increased in indiana between 1997 and 2010.36 cancer is the second leading cause of death in indiana, just behind heart disease, which also is linked to obesity.37 further, the medical costs associated with overweight and obese adults are estimated at 147 billion dollars nationally.38 more alarming, obesity is a leading cause of preventable death, claiming 200,000 lives in the united states annually.39 obesity is even more prevalent than smoking and is associated with chronic health conditions, along with overall poor physical health.40 poor diet and physical inactivity are considered to be the biggest lifestyle contributors to obesity in general.41 obesity affects not only the health of americans, but also the nation’s economy. employers are also increasingly 32 ind. state dep’t of health, the burden of obesity related cancers and the promotion of physical activity in indiana (2014), in.gov, http://www.in.gov/isdh/files/obesity_report_2014_(2).pdf. 33 id. at 4. 34 id. at 5. 35 id. at 6. 36 id. 37 indiana: burden of chronic diseases, centers for disease control and prevention, http://www.cdc.gov/chronicdisease/states/ pdf/indiana.pdf (last visited feb. 28, 2014). 38 eric a. finkelstein et al., annual medical spending attributable to obesity: payer-and service-specific estimates, 28 health affairs w822, w828 (2009). 39 united health found., obesity: united states, america’s health rankings, http://www.americashealthrankings.org/all/ obesity/disparities (last visited dec. 17, 2014). 40 id. 41 id. http://dx.doi.org/10.1377/hlthaff.28.5.w822 392 indiana health law review vol. 12:1 concerned with obesity as an epidemic, due to controlling health care costs and maintaining productive workers.42 in 2001, obesity cost employers $13 billion a year, “including $8 billion for health insurance, $2.4 billion for sick leave, $1.8 billion for life insurance, and another $1 billion for disability insurance.”43 obese workers are almost twice as likely to be frequently absent from work than people of a healthy weight according to a study conducted by brigham young university health promotion professor, larry tucker.44 annually, obesity-related illness costs employers 39.3 million lost work days, 239 million days of reduced productivity, and 62.7 million doctor visits.45 the united health foundation published its yearly report titled, “america’s health rankings” in 2012. this report ranks each state based on rates of air pollution, binge drinking, cancer deaths, cardiovascular deaths, children in poverty, diabetes, early prenatal care, geographic disparity, high school graduation rate, immunization coverage, infant mortality, infectious disease, lack of health insurance, obesity, occupational fatalities, poor mental health days, poor physical health days, premature death, preventable hospitalizations, primary care physicians, public health funding, smoking, violent crime, cardiac heart disease, cholesterol check, annual dental visit, diet consisting of fruit and vegetables, heart attack, high blood pressure, high cholesterol, income disparity, low birth weight, low health status, median household income, personal income per capita, physical activity, preterm birth, stoke, teen birth rate, underemployment rate, and unemployment rate.46 after taking these extensive factors into account, researchers ranked each state overall in the nation. indiana came out forty-first this year, compared to its rank of thirty-seventh 42 wakefield, supra note 2. 43 id. 44 id. 45 id. 46 united health found., overall state rankings, america’s health rankings, http://statehealthstats.americashealthrankings.org/ #/country/us/2011/overall-state-ranking (last visited oct. 8, 2013). 2015 combating obesity one step at a time 393 in 2011.47 when specifically looking at the obesity factor, indiana is ranked forty-second in the nation, showing an increased obesity rate since even last year.48 additionally, the study shows that factors correlated with indiana’s high obesity ranking include diets low in fruit and vegetables and physical inactivity.49 in january 2011, one year before the new statistics were released in 2012, the indiana state department of health released a statement, “indiana takes next step in tackling obesity.”50 in the press release, state health commissioner, dr. gregory larkin, explained that only 41% of adolescents and 64% of adults meet the recommended levels for physical activity.51 in addition, obesity and obesity related diseases are costly to the state of indiana. medicare and medicaid pay about half of all costs associated with obesity.52 indiana’s obesity-attributable health care spending in 2008 was estimated at $1.9 billion or $435 per adult.53 if trends continue, indiana’s obesity attributable health care spending could reach as high as $7 billion or $1,484 per adult by 2018.54 indiana must find innovative ways to promote physical activity and healthy lifestyles to ensure that obesity related health care costs remain the same or decline in future years. in addition to the 2011 press release, the indiana state department of health issued a report titled, “burden of obesity in indiana.” here, dr. larkin asserted that indiana’s overweight and obesity rate has increased 13% 47 united health found., state data > indiana, america’s health rankings, http://www.americashealthrankings.org/in (last visited oct. 8, 2013). 48 united health found., supra note 23. 49 id. 50 press release, ind. state dep’t of health, indiana takes next step in tacking obesity (jan. 28, 2011) (available at http://www.in.gov/icw/files/pr_1.28.11.pdf). 51 id. 52 hensrud, supra note 26. 53 ind. state dep’t of health, supra note 50. 54 id. 394 indiana health law review vol. 12:1 since 1995.55 the study sought to determine which hoosiers were at the highest risk of becoming overweight or obese and what were the forces behind the increasing rates across the state.56 adult married men between the ages of thirtyfive and seventy-four, not engaging in at least 300 minutes of moderate exercise per week were found to be the highest risk group for adults.57 the environmental factors that contribute to the rising levels of obesity include: busy lifestyles; greater access to inexpensive, high-calorie, fat and sugar-laden food; and the convenience and affordability of eating out more often.58 in addition, our physical environment does not make basic physical activities, such as walking and riding a bicycle, attractive or safe. the result is a diet poor in fruit and vegetable consumption and a lack of physical activity, two of the major factors that contribute to obesity.59 more recently, indiana’s behavioral risk factor surveillance system (“brfss”)60 indicated that only 17.3% of adults and 24.2% of high school students were meeting the recommended levels for physical activity in 2012.61 if these trends continue, the obesity rate in indiana is projected to be at 56% by 2030.62 indiana’s response to these staggering statistics was to create the indiana healthy weight initiative, which seeks to improve health and quality of life for indiana residents.63 this is part of a five year federal grant from the cdc to improve healthy eating and physical activity in indiana to 55 ind. state dep’t of health, 2011 burden of obesity in indiana 1 (2011), available at http://www.in.gov/isdh/files/ burden_of_obesity_ final_11_18_2011.pdf. 56 id. 57 id. 58 id. 59 id. 60 behavioral risk factor surveillance system (“brfss”) is the world’s largest telephone survey that tracks health risks in the united states. 61 marcie l. memmer, healthy people, healthy communities (2013). 62 id. 63 new and noteworthy, supra note 6. 2015 combating obesity one step at a time 395 combat the negative effects of obesity.64 the initiative’s task force developed indiana’s comprehensive nutrition and physical activity plan, 2010-2020, which focuses on policy and environment change for obesity prevention and healthier living.65 the task force has outlined six goals the plan hopes to achieve.66 these include: increasing access to and consumption of healthy foods and beverages; increasing opportunities for and engagement in physical activity; increasing efforts aimed at enabling people to achieve and maintain a healthy weight across the lifespan; reducing environmental and policy-related disparities for breastfeeding; nutrition; physical activity; overweight; obesity and chronic disease; increasing the capacity of communities and settings within those communities (e.g., schools, worksites, faith-based organizations, etc.) to develop and sustain environmental and policy support systems that encourage healthy eating and active living; and increasing state and local strategic partnerships to more effectively coordinate efforts, share resources, and identify and reach priority populations.67 complete streets policy is part of this initiative and is driven by health by design, an indianapolis based coalition that brings together advocates of community design, transportation, and health to support healthy and active lifestyle choices.68 state leaders desperately need to find solutions for obesity, as a costly problem in indiana, which negatively affects a significant portion of the population. part of this solution could be statewide complete streets legislation if organizations, community members, and state legislators express its need and priority in the general assembly. 64 ind. state dep’t of health, supra note 50. 65 nat’l ctr. for chronic disease prevention and health promotion, supra note 4. 66 ind. state dep’t of health, supra note 50. 67 id. 68 indiana complete streets coalition, supra note 11. 396 indiana health law review vol. 12:1 b. complete streets outside indiana over 500 complete streets policies have been implemented nationwide.69 in 2012 alone, 125 communities adopted complete streets policies.70 communities both small and large have adopted complete streets, showing that these policies are effective in and beneficial to communities of all sizes. fifty-two percent of the current implemented policies are in suburbs, 26% in large, midsize, and small cities, and 22% in small and rural towns.71 additionally, nineteen states have adopted statewide complete streets legislation across the united states, including colorado, california, and vermont, to name a few.72 colorado was ranked first for low rates of statewide obesity, compared to california, which ranked tenth, and vermont, which ranked eighth.73 the obesity rate in colorado is currently 19.1% and by 2018 is projected to be the only state where less than 30% of adults are overweight.74 nationally, the safe streets act of 2013 was introduced in the house by representatives matsui and joyce.75 as written, the bill would ensure that all users of the transportation system, including people walking, biking, taking public transportation, or driving, as well as children, 69 smart growth am. & nat’l complete sts. coal., the best complete street policies of 2012 3 (2013), available at http://www.smartgrowthamerica.org/documents/cs-2012-policyanalysis.pdf. 70 id. 71 health by design, complete street policies: statewide trends and developing a policy that works 7 (2012), available at http://www.healthbydesignonline.org/documents/completestreetspolicie sandstatewidetrends_ziabrucaya.pdf. 72 changing policy complete streets development 101: presentation, smart growth am., http://www.smartgrowthamerica.org/ complete-streets/changing-policy (last visited sept. 25, 2014). 73 united health found., supra note 46. 74 william sadler, complete streets make healthier people: reforming street design policies to combat obesity 2, congress for the new urbanism, http://www.cnu.org/sites/www.cnu.org/ files/sadlerb_cnu18.pdf (last visited dec. 18, 2014). 75 national complete streets coalition, on the hill, the safe streets act, smart growth am., http://www.smartgrowthamerica.org/ complete-streets/federal-policy/on-the-hill (last visited sept. 25, 2014). 2015 combating obesity one step at a time 397 older adults, and individuals with disabilities, are able to travel safely and conveniently on our streets.76 this legislation did not pass in 2013, but still is receiving support from the national complete streets coalition, which is powered by smart growth america. vermont enacted complete streets legislation in 2011. vermont has implemented several design changes with complete streets to promote safety.77 these changes include: retiming crossing signals to allow for slower walking speeds; adding/maintaining sidewalks that are connected to services; installing curb ramps, sidewalk seating, and bus shelters with seating; improving lighting, signage with larger fonts, and reflective signs and pavement markings; and protecting left turn lanes with green arrows (this can cut left turn crashes in half).78 california implemented complete streets with the mission of “improving mobility across california.”79 complete streets in california seek to result in more options for people to go from one place to another; less traffic congestion and greenhouse gas emissions; more walkable communities (with healthier, more active people); and fewer barriers for older adults, children, and people with disabilities.80 california also recognizes the economic benefits that complete streets legislation offers. economically, complete streets helps revitalize communities, giving families 76 id. 77 gov. shumlin signs complete streets bill, vt., http://governor.vermont.gov/media-complete-streets (last visited jan. 3, 2014). 78 id. 79 complete streets program, cal. dep’t of transp., http://www.dot.ca.gov/hq/tpp/offices/ocp/complete_streets.html (last visited sept. 25, 2014). 80 id. 398 indiana health law review vol. 12:1 opportunities to lower transportation costs by using public transit, walking or biking to travel to their destinations.81 indiana’s neighbor, michigan, recently enacted statewide complete streets legislation in hopes of reducing its standing of ninth highest state obesity rate in the nation. like indiana, the michigan department of community health created a strategic plan to reduce childhood obesity specifically within the state.82 complete streets quickly became a state initiative that was of highest priority with the department of community health, raising awareness that statewide efforts were underway.83 communities with local complete streets ordinances were vocal to legislators about their support for a statewide complete streets policy. community members attended legislative hearings, expressing support for complete streets, which caught the attention of michigan lawmakers.84 in 2010, after two years, statewide complete streets legislation was passed requiring the michigan department of transportation to consider all legal users of the roads in its planning from public transportation riders and motorists, to bicyclists and pedestrians.85 the michigan department of transportation works with the michigan department of community health and the healthy kids, healthy michigan initiative to help plan built environments for local communities and seeks to promote physical activity. this shows that enacting and implementing a statewide complete streets policy takes commitment from both state agencies and community groups. complete streets policies have been effective across the nation in re-connecting communities and promoting physical activity, as a way to reduce the nationwide epidemic of obesity. states and localities are greatly 81 id. 82 nat’l ctr. for chronic disease prevention and health promotion, taking it to the (complete) streets: michigan’s road to fight obesity (2011), available at http://www.cdc.gov/obesity/downloads/field/stories-from-thefield_michigan-web_3-7-12.pdf. 83 id. 84 id. 85 id. at 2. 2015 combating obesity one step at a time 399 benefiting from these recently adopted policies geared toward making streets accessible for all users. states like colorado, california, and vermont have already increased mobility and physical activity, decreased transportation costs, and effectively revitalized communities in the short time that these statewide policies have been in place. additionally, the state obesity rates in colorado, california, and vermont are much lower than in indiana. these policies are most successfully implemented when communities unite with the legislature and state agencies to achieve goals that can benefit the state as a whole. this action begins with citizens, grows with support from groups, and gains the most momentum when state agencies get involved. the states with the most accomplished complete street policies worked together as communities to achieve the effort. c. complete streets across indiana the indiana communities of bloomington, madison county, lake/porter county, columbus, richmond, evansville, frankfort, tippecanoe county, indianapolis, and westfield have all adopted complete streets policies. complete streets are now available to 36% of hoosiers.86 in 2012, the national complete streets coalition named indianapolis’ newly adopted ordinance the best complete streets policy in the nation.87 in response to this announcement, indianapolis mayor greg ballard stated, “we’re very proud of our efforts in the past few years to make indianapolis more walkable, bikeable and connected. the strength of our complete streets plan is its clear commitment to achieving a vibrant, healthy city. now, we’re working to make our plan a reality with safe and accessible transportation options for all residents.”88 indianapolis’ complete streets policy includes improvements 86 ind. cancer consortium, http://indianacancer.org/blog/ completestreetsinfograph/ (last visited jan. 3, 2015). 87 indy tops ‘complete streets’ list, inside ind. bus. (apr. 8, 2013) http://www.insideindianabusiness.com/newsitem.asp?id=58810. 88 id. 400 indiana health law review vol. 12:1 to sidewalks, bike lanes, special bus lanes, comfortable and accessible transportation stops, frequent and safe crossing opportunities, median islands, accessible pedestrian signals, curb extensions, narrower travel lanes, and roundabouts.89 indycog, aarp, and health by design made this local initiative possible with the help of other community members.90 the national complete streets coalition evaluated the policies nationwide on ten ideal elements. these include: vision and intent, all users and modes, all projects and phases, clear, accountable exceptions, network, jurisdiction, design, context sensitivity, performance measures, and implemented next steps.91 the elements are considered the policies that represent the best practices from the research and experience of the national complete streets coalition steering committee and workshop instructors.92 indianapolis was highlighted in the coalition’s report most distinctly under the “performance measures” element. the policy language reads, the city shall measure the success of this complete streets policy using, but not limited to, the following performance measures: total miles of bike lanes, linear feet of new pedestrian accommodation, number of new curb ramps installed along city streets, crosswalk and intersection improvements, percentage of transit stops accessible via sidewalks and curb ramps (beginning in june 2014), rate of crashes, injuries and fatalities by mode, rate of children walking or bicycling to school (beginning in june 2014). unless otherwise noted above, within six months of 89 we have a complete streets ordinance in indianapolis!, indycog, http://indycog.org/indycompletestreets (last visited sept. 2, 2014). 90 id. 91 smart growth am. & nat’l complete sts. coal., supra note 69, at 7-14. 92 id. 2015 combating obesity one step at a time 401 ordinance adoption, the city shall create individual numeric benchmarks for each of the performance measures included, as a means of tracking and measuring the annual performance of the ordinance. quarterly reports shall be posted on-line for each of the above measures.93 indianapolis also was considered the top policy regarding “implementation next steps.” overall, indianapolis received a score of 89.6 out of 100, with hermosa beach, ca and huntington beach, ca tying for second with a score of 85.6.9495 this study was conducted in 2012 and evaluated all of the complete streets policies in place nationwide.96 indianapolis being ranked number one in the united states shows the degree of success the state as a whole could achieve in terms of combating obesity by promoting physical activity in communities statewide. the language contained in the city’s highly successful policy may provide a model template for the development of statewide legislation. in addition to complete streets, the indiana healthy weight initiative has partnered with the indiana department of transportation (“indot”) to fund a program called, “safe routes to school.”97 indot has funded nineteen projects around the state to promote walking and biking to school with more than 3.4 million in awards in 2012.98 the indiana healthy weight initiative hopes to add fifty schools that will implement infrastructure improvements that promote walking and biking to school by 2020.99 additionally, health by design, indot, and the indiana department of health promote walk to school 93 id. at 14. 94 id. at 6. 95 other policies noted on the list for excellence include: ocean shores, wa; northfield, mn; portland, me; oak park, il; trenton, nj; clayton, mo; and rancho cucamonga, ca. 96 id. at 1. 97 memmer, supra note 61. 98 id. 99 id. 402 indiana health law review vol. 12:1 day.100 this growing indiana program is another example of how completing indiana’s streets could benefit hoosiers of all ages, especially school-aged children on the journey to school. statewide complete street legislation was proposed in the indiana general assembly in 2010, 2011, and 2013 showing that hoosiers have an interest in implementing statewide legislation.101 by enacting a statewide law, indiana has a better chance to uniformly fight obesity with complete streets instead of leaving the decision to localities that may not be able to afford, or have the desire to undertake, such efforts for its citizenry. additionally, a statewide policy could better connect communities within the state, making travel easier without an automobile. d. the empirical evidence base for built environment and complete streets since the 1980s, energy intake of resources such as oil to make gasoline has increased, while human energy expenditure has declined, showing an energy imbalance that mirrors the obesity rate in the united states.102 what does this mean? people are less active today than they were decades ago. overall rates of sports and leisure activity levels have remained constant and even increased in some instances, but this only accounts for a small amount of physical activity.103 physical activity associated with home, work, and transportation has declined due to changes in economic growth, technological advancements, and social change.104 in the 1950s in the united states, 30% of americans worked in high-activity professions.105 by 2000, this number fell to 22%.106 additionally, the number of 100 id. 101 indiana complete streets coalition, supra note 11. 102 united health found., supra note 39. 103 physical activity, harv. sch. pub. health, http://www.hsph.harvard.edu/obesity-prevention-source/obesitycauses/physical-activity-and-obesity/ (last visited jan. 18, 2014). 104 id. 105 id. 106 id. 2015 combating obesity one step at a time 403 americans working in low-activity “desk jobs” rose from 2341%.107 increased use of automobiles and reduced use of public transportation is another big issue. driving cars increased from 67% of all trips to work in 1960 to 88% in 2000.108 decreased levels of activity lead to more sedentary lifestyles, which include watching television, playing video games, and using the computer to accomplish tasks that once required leaving work or home.109 more recent evidence indicates the importance of environment in the obesity epidemic and the need for changes in built environment to better facilitate change in lifestyle.110 in 2007, mia papas and her colleagues published, the built environment and obesity in epidemiologic reviews.111 papas analyzed the relationship between the built environment and obesity. the built environment has been thought to play an important role in influencing obesity by creating a climate that promotes increased energy consumption and a reduction in energy expenditure.112 built environment includes aspects of a person’s surroundings that are human-made or modified, unlike natural aspects of the environment.113 aspects of built environment consist of housing, urban development, land use, transportation, industry, and agriculture.114 assessing the downfalls of the current built environment is helpful to communities looking to implement obesity prevention plans. this can lead to more user friendly streets and community connectedness if the right changes are made. the article examined the published empirical data for the influence of built environment on the risk of obesity.115 the studies that were reviewed required a direct measure of 107 id. 108 id. 109 id. 110 united health found., supra note 39. 111 mia a. papas et al., the built environment and obesity, 29 epidemiologic. rev. 129, 129-30 (2007). 112 id. 113 id. 114 id. at 130. 115 id. at 131. http://dx.doi.org/10.1093/epirev/mxm009 404 indiana health law review vol. 12:1 body weight (i.e. body mass index) and at least one objective measure of built environment.116 papas and her colleagues selected twenty studies to review that fit within this criteria.117 seventeen of the twenty studies reviewed indicated a statistically significant relationship between some aspect of built environment and obesity.118 access to physical activity and access to food outlets were measures of built environment used in these studies.119 additionally, the researchers broke these categories into subsections and inquired about sidewalk availability, proximity to play space/recreational facilities, fast-food restaurant proximity, and daily number of miles driven in a car per day, just to name a few.120 papas concluded that studies are increasingly showing a strong connection between built environment and obesity rates, which provides evidence that built environment, is of importance in community based prevention plans.121 papas advocated for continued study of the relationship between built environment and obesity, so that communities may have more evidence to conclude that changes in built environment are necessary to curb high obesity rates. fazal khan’s recent article, “combating obesity through the built environment: is there a clear path to success?” also discusses how built environment can be implemented to curb the detrimental effects of obesity. khan, like papas, stated that increasing evidence supports a link between built environment and obesity and wonders what legislators will do when presented with this information.122 changes to the built environment can be expensive at the outset, causing it to be overlooked as a way to lower obesity rates, despite the evidence showing its link to obesity. cost prohibits legislators from seriously considering change to 116 id. 117 id. 118 id. at 138. 119 id. 120 id. 121 id. at 141. 122 fazal khan, combating obesity through the built environment: is there a clear path to success?, 39 j.l. med. & ethics 387, 387 (2011). http://dx.doi.org/10.1111/j.1748-720x.2011.00608.x 2015 combating obesity one step at a time 405 the built environment, even though communities that have already implemented such changes have seen positive results. studies have shown that children and adolescents with access to parks and recreational facilities near their homes are more physically active than those who lack access.123 another study showed that children who live in neighborhoods without access to parks or green spaces are 1.21 times more likely to be obese.124 these studies demonstrate that the environment in which people live does matter and correlates to levels of physical activity. despite these findings, there exists “no consensus that aspects of the built environment promote obesity.”125 researchers like papas advocate for further research and conclude that current studies are still in the infancy stage.126 still this should not discourage built environment advocates, because even with the small number of these studies, communities are implementing change in built environment nationwide through complete street policies. harvard school of public health published the article, “environmental barriers to physical activity,” which explains how where we live, learn, work, and play impacts how active we are.127 specifically, how families, worksites, and neighborhoods affect a person’s physical activity level. influencing children to be physically active begins with families. parents significantly influence how active their children are based on buying sports equipment, taking children to sports practice or other recreational activities, and setting examples as models for healthy living. studies have shown that paternal activity levels, positive reinforcement, maternal participation, sibling involvement, time spent outdoors, and family income all influence how active a child will become.128 123 id. at 388. 124 id. 125 id. at 389. 126 id. 127 environmental barriers to physical activity, harv. sch. pub. health, http://www.hsph.harvard.edu/obesity-preventionsource/obesity-causes/physical-activity-environment/ (last visited aug. 23, 2014). 128 id. 406 indiana health law review vol. 12:1 workplace is another huge aspect of determining a person’s level of physical activity. employed adults spend a quarter of their lives at work and are often adversely affected by the pressure and demands of their jobs.129 even though an increased number of americans are working long hours while sitting at a desk, some employers have implemented on-site gyms or discounts to local gyms within the community.130 the built environment also determines how people get to work. people tend to be more active in their commutes if sidewalks, bike lanes, or opportunities to take public transit are available.131 studies have shown that in workplaces with bike storage and cultural support for active commuting, employees are more likely to walk and bike to work.132 unfortunately, americans only use bicycles for 1% of all trips.133 in contrast, people in the netherlands use bicycles for 27% of all trips.134 however, americans are increasing walking as a method of transportation.135 walking accounted for 10.5% of all trips in 2009. this number was up from 8.6% in 2001.136 neighborhoods also impact individual activity levels. neighborhoods with sidewalks, bike lanes, and infrastructure that make crossing the streets safe all encourage physical activity.137 lower income and minority neighborhoods tend to have fewer recreational facilities than wealthier neighborhoods.138 one study looked at recreation facilities in neighborhoods across manhattan and the bronx, greater baltimore and forsyth county, north carolina.139 it found that minority neighborhoods were three to eight times more likely to lack recreational facilities than wealthier, predominantly white 129 id. 130 id. 131 id. 132 id. 133 id. 134 id. 135 id. 136 id. 137 id. 138 id. 139 id. 2015 combating obesity one step at a time 407 neighborhoods.140 safe communities also tend to have more active people, as parents feel comfortable letting children play outside and people feel at ease walking around outside. a recent study conducted in los angeles found that residents who perceived their neighborhoods as dangerous to have higher bmis than those who considered their neighborhoods safe.141 the biggest problems with linking built environment and obesity are not only that relatively few studies have been conducted where evidence has been conclusive, but also that this research is incredibly complex. researchers are currently struggling with the vast amount of factors that go into the relationship between built environment and obesity. some factors that are considered include relationships between community design, patterns of social interaction, the formation of a sense of community cooperation, aspects of safety and security, air and water quality, and mental health.142 another issue is that there are differences in what works for encouraging adults versus children to exercise. “[w]hile we can’t safely say that certain changes in community design will lead to increases in physical activity, we can safely say that certain changes in community design will increase opportunities for physical activity,” said susan handy, environmental science and policy professor at the university of california, davis.143 for these successful strategies to be implemented, governments and communities must work together, as prevention is critical for children, families, communities and workplaces. this is essential, because obesity proves difficult to treat after the fact.144 despite the lack of consensus in the public health community relating built environment and obesity, research consistently shows that increased rates of physical activity help people keep weight steady, while increased rates of a sedentary lifestyle tend to make people gain weight over 140 id. 141 id. 142 wakefield, supra note 2. 143 id. 144 id. 408 indiana health law review vol. 12:1 time.145 in a study conducted by cris slentz and others, 175 adults were randomly assigned to either the control group that received no exercise instruction, or to one of three exercise regimens.146 low-intensity participants walked about twelve miles per week, medium-intensity participants jogged about twelve miles per week, and high-intensity participants jogged about twenty miles per week.147 all study volunteers were asked to stick to their regular diets.148 after six months of participation in the study, researchers found that subjects in the high-intensity exercise group lost abdominal fat, whereas those assigned to the low and medium-intensity exercise groups did not.149 even though this specific study found that the highintensity group reaped the greatest benefits in the study, increasing physical activity of any kind and duration is a step in the right direction. researchers believe that any kind of physical activity can prevent obesity in a number of ways. first, physical activity increases a person’s energy expenditure, which helps them stay in energy balance or even lose weight.150 next, physical activity decreases fat around the waist, and total body fat, which slows the development of abdominal obesity.151 last, physical activity reduces depression and anxiety, which may motivate people to increase physical activity levels after discovering its many benefits.152 unfortunately, individual choice is not the only influence of physical activity. the built environment (buildings, neighborhoods, transportation systems, and other human made elements of the landscape) influences how active people are.153 for example, people are 145 environmental barriers to physical activity, supra note 127. 146 cris a. slentz et al., inactivity, exercise, and visceral fat. strride: a randomized, controlled study of exercise intensity and amount, 99 j. applied. physiology. 1613, 1613-1618 (2005). 147 id. 148 id. 149 id. 150 frank b. hu, physical activity, sedentary behaviors, and obesity 301-19 (2008). 151 id. 152 id. 153 environmental barriers to physical activity, supra note 127. http://dx.doi.org/10.1152/japplphysiol.00124.2005 2015 combating obesity one step at a time 409 more likely to be physically active if they live near parks and playgrounds, in neighborhoods with sidewalks or bike paths, or close enough to work, school, or shopping that they can travel to on bike or on foot.154 people tend to be less active if they live in areas of suburban sprawl, where there are fewer opportunities for recreation.155 these studies show that our surroundings and state and local policies shape how active people are in their daily lives. lack of activity is no doubt a major contributing factor to the obesity epidemic.156 making communities “activity friendly” is a way to combat this issue.157 this includes opportunities for walking and biking, parks and playgrounds, and safe neighborhoods.158 complete streets is an effective policy that could increase physical activity rates in indiana, by making communities more “activity friendly.” other states that have adopted statewide complete streets legislation have lower rates of obesity. for example, colorado was ranked first for low rates of statewide obesity, compared to california ranked at tenth and vermont ranked eighth.159 these states with low obesity rates all have statewide complete streets legislation, indicating how effective change in built environment can be. this also indicates that states with low obesity rates are dedicated to keeping their citizens healthy. the same states ranked above showed high rates of physical activity, with colorado ranked fourth, california ranked tenth, and vermont ranked second.160 the correlation between changing environments and higher levels of physical activity indicates that statewide complete street policies are at least somewhat effective in increasing physical activity levels and decreasing obesity rates. some may argue that states like california, colorado, and vermont have cultural differences from indiana that 154 id. 155 id. 156 id. 157 id. 158 id. 159 united health found., supra note 46. 160 id. 410 indiana health law review vol. 12:1 allow for more activity, which causes lower statewide obesity rates. however, this is a myth and generally a stereotype about western and eastern states. despite the fact that california is generally in a warmer climate than indiana, this is not true of colorado and vermont. the biggest difference between these states with lower statewide obesity rates and statewide complete streets legislation and indiana is that their communities and leaders made opportunities of physical activity a priority for its citizenry. this includes providing infrastructure, so citizens have alternative means of transportation, other than just driving around in cars. additionally, research shows that the way streets, sidewalks, and transportation are designed affects individual rates of physical activity.161 a study of atlanta residents showed that people living in the most walkable neighborhoods were 35% less likely to be obese, than those living in the least walkable areas.162 this suggests that providing the opportunity for physical activity often correlates to actual increased rates of physical activity. e. additional benefits of enacting complete streets legislation not only do complete streets promote physical activity, but they also promote community growth, which in effect supports the economy. several local complete streets policies have shown to be successful and transformative for communities economically. valencia street in san francisco had 40% of merchants report increased sales, while 60% reported that more area residents were shopping locally due to the complete streets policy.163 barracks row 161 nat’l policy & legal analysis network, what are complete streets? a fact sheet for advocates and community members, change lab solutions (feb. 2010), http://changelabsolutions.org/sites/default/ files/completestreets_factsheet_final_20100223.pdf. 162 id. 163 ind. cancer consortium, complete streets, ind. cancer, http://indianacancer.org/wpcontent/uploads/2012/10/completestreets_10_1.jpg (last visited oct. 7, 2013). 2015 combating obesity one step at a time 411 in washington d.c., attracted forty-four new businesses and 200 new jobs as a result of new sidewalks, parking spaces, and traffic lights.164 most profoundly, portland, oregon reported that a regional trails program saves the city approximately 115 million per year in health care costs.165 in addition to improving economic growth, complete streets policies improve safety by reducing crashes through safety improvements, help ease transportation woes, help children, are good for air quality, and make fiscal sense.166 safety is improved by specifically designing infrastructure for pedestrians, including installing raised medians and redesigning intersections and sidewalks.167 one study found that implementing complete streets policies reduced pedestrian risk by 28%.168 streets that provide for multiple travel options reduce traffic jams and increase the total transportation network capacity.169 this can help reduce congestion, especially at rush hour times of the day. children benefit from complete streets policies, which allow them to travel to and from school safely either on foot or by bicycle. indiana, along with other states, has implemented safe routes to school programs that complete streets legislation would benefit. further, complete streets policies improve air quality by allowing people to walk, ride bicycles, or take public transportation more easily. poor air quality in urban areas leads to increases in illnesses like asthma.170 if each resident of an american community of 100,000 replaced one car trip with one bike trip just once a month, carbon dioxide (co2) emissions would be cut by 3,764 tons per year in the 164 id. 165 id. 166 national complete streets coalition: benefits of complete streets, smart growth am., http://www.smartgrowthamerica.org/complete-streets/complete-streetsfundamentals/benefits-of-complete-streets/ (last visited jan. 24, 2014). 167 id. 168 id. 169 id. 170 id. 412 indiana health law review vol. 12:1 community.171 this is an example of how complete streets policies can reduce illnesses other than those related to obesity. lastly, complete streets policies are fiscally smart because integrating sidewalks, bike lanes, transit amenities, and safe crossings into initial design processes saves costs on retrofit projects after the fact.172 jeff morales, former director of caltrans, stated, “by fully considering the needs of all non-motorized travelers (pedestrians, bicyclists, and persons with disabilities) early in the life of a project, the costs associated with, including facilities for these travelers are minimized.”173 older americans also benefit from complete streets policies because as americans age, they tend to have a harder time traveling around. by 2025, nearly one in five americans will be aged sixty-five or older.174 complete streets policies provide more opportunities for older americans to walk places and get out, without the need to drive a car. this is important to a large percentage of aging adults, who become unable to drive and dependent on relatives to get around in the community. iii. analysis of complete streets to combat hoosier obesity complete streets are a built environment approach to promoting physical activity in indiana communities. they are designed to accommodate all users, including: pedestrians, bicyclists, motorists, wheelchair users, and public transit users.175 over the past several years, implementation of complete streets policies has grown increasingly popular on the federal, state, and local levels. developing complete streets provides users with access to infrastructure that does not require use of an automobile to get to places around the community. complete streets legislation was proposed in the 2010, 2011, and 2013 171 id. 172 id. 173 id. 174 id. 175 indiana complete streets coalition, supra note 11. 2015 combating obesity one step at a time 413 sessions of the indiana general assembly, but did not pass. still, localities in indiana are implementing complete street policies as a way to promote community connectedness and physical activity, while fighting continued high obesity rates within the state. this year complete streets legislation has again been proposed. by passing complete streets legislation, indiana as a whole, could better design its streets to give hoosiers more opportunities to stay physically active in their communities and reduce obesity related health care costs. in indianapolis’ recently enacted complete streets ordinance the policy language incorporates the importance of completing streets to combat obesity: whereas, in marion county, 40% of our children are overweight or at-risk for becoming overweight and nearly two-thirds of adults are overweight or obese, and incomplete streets mean many people lack opportunities to be active as part of daily life. 176 as proposed, statewide complete streets legislation would ensure that the indot will design and operate roads with all users in mind.177 this includes pedestrians, bikers, pedestrians, mass transit users, and individuals with disabilities. when a street is “complete” walking and biking are seen as more attractive modes of transportation than just hopping in the car to go somewhere.178 as a result, complete streets promote physical activity and make nonmotorists feel like they have a safe alternative for getting to work, school, and back home. studies have shown that people who live in walkable communities get thirty-five to forty-five additional minutes of moderate physical activity compared to those who do not.179 this is just one piece of evidence showing that if people have access to 176 indianapolis-marion county, ind., ordinance ch. 431, art. viii, § 801 et. seq. (2012). 177 s.b. 450, 118th gen. assemb., reg sess. (ind. 2013). 178 indiana complete streets coalition, supra note 11. 179 ind. cancer consortium, supra note 163. 414 indiana health law review vol. 12:1 infrastructure that promotes physical activity, they are more likely to take advantage of the benefits it offers. in 2008, california’s governor signed into law the complete streets act, co-sponsored by california bicycle coalition and the american association for retired people (aarp) california.180 the law requires cities and counties when updating roadways to account for the needs of all roadway users. some specific users include bicyclists and elderly individuals, who interest groups represented in support of california’s complete streets legislation. in 2011, vermont’s governor signed a complete streets bill into law. many interest groups including aarp vermont and the vermont natural resources council worked with legislators advocating for the passage of the bill.181 the governor noted, “this law will guarantee that we’re designing roads that work for the future for older vermonters, for those who choose to take public transportation, for people who opt to walk to their jobs and errands, and for motorists.”182 one of the provisions of vermont’s legislation provides retiming crossing signals to allow for lower walking speeds.183 this makes it easier for elderly people and those who are disabled to get around in the community without using an automobile. for complete streets legislation in indiana to succeed, interests groups like health by design must collaborate with other groups to show indiana legislators that a complete streets policy would not only be useful in the state, but largely beneficial. health by design is an initiative funded by the non-profit, the alliance for health promotion. health by design seeks to increase walking, biking, and public transit options; increase neighborhood, city, and regional connectivity; encourage land-use decision making that promotes public health; and reduce dependency on automobiles.184 health by design is the major in-state 180 complete streets, supra note 12. 181 gov. shumlin signs complete streets bill, supra note 77. 182 id. 183 id. 184 health by design, http://www.healthbydesignonline.org/ index.html (last visited aug. 23, 2014). 2015 combating obesity one step at a time 415 group working toward implementation of a statewide complete streets policy. the organization provides complete streets workshops across the state for localities and is responsible for the implementation of the current complete streets policies in place in indiana.185 like in california and vermont, indiana aarp may be interested in supporting increased opportunities of transportation for its members. indiana bicycle coalition is another group likely to support statewide complete streets legislation. currently, the indiana bicycle coalition has a license plate that can be purchased at the bmv. bicycle indiana uses the proceeds from the license plate sales to work to improve bicycling in communities throughout indiana, support the development of bike lanes and greenways, create and distribute educational safety materials, and advocate safer roads for everyone.186 complete streets in indiana would definitely benefit the goals of bicyclists and those working in support of the indiana bicyclist coalition. in 2006, indiana expanded the indiana state trails, greenways, and bikeways plan funding from $10 million to $20 million to encourage healthy habits, promote tourism, and enhance indiana’s ability to attract new investments and jobs.187 this initiative has similar benefits that complete streets seek to address, but differs because trails, greenways, and bike lanes are completely new structures that require new construction. the indiana department of natural resources, along with the indiana department of transportation, the governor’s council for physical fitness and sports, the indiana department of tourism and the indiana economic development corporation produced this trails plan to guide development and expansion of a statewide trails system for transportation and recreational use.188 making streets complete in indiana would not 185 indiana complete streets coalition, supra note 11. 186 indiana bicycle coalition, bureau of motor vehicles, http://www.in.gov/bmv/2778.htm (last visited aug. 23, 2013). 187 ind. dep’t of natural res., hoosiers on the move: the indiana state trails, greenways, and bikeways plan (2006). 188 id. 416 indiana health law review vol. 12:1 require entirely new infrastructure like in the trails plan, but rather updating the current streets and sidewalks, which would prove less costly. also, complete streets are used for transportation, not only recreational use. after the streets have been made “complete,” only the costs for routine maintenance are needed, with no further expenditures required. this is unlike most current streets, which require retrofit construction. individual communities across indiana are showing support for the trails. in fort wayne, three non-profit trails organizations combined to expand the trails and greenways. aboite new trails, the greenway consortium, and northwest allen trails have become united as fort wayne trails. over the past six years, these non-profits independently succeeded in funding forty-one miles of trails in the fort wayne area all through grass root support.189 fort wayne trails’ mission is to enhance the community by developing an “ever-expanding” network of trails.190 funding for the trails comes from local businesses, the community, and the state government.191 without this support, the trails could not be sustained. on the state level, the greenways foundation, in partnership with indiana trails seeks to promote the growth, enhancement, and use of indiana trails and greenways.192 trails and greenways are present across indiana and the greenways foundation seeks to expand trails and greenways, so that they are accessible to all hoosiers. the greenways foundation is a non-profit that works with citizens and governmental entities in planning and promoting indiana trails and greenways.193 organizations like the greenways foundation and fort wayne trails want to make indiana a healthier and a more desirable place to live through the development of trails. 189 about us, fort wayne trails, http://fwtrails.org/about/ (last visited sept. 25, 2014). 190 id. 191 id. 192 what we do, greenways foundation, www.greenwaysfoundation.org/about.html (last visited jan. 1, 2014). 193 id. 2015 combating obesity one step at a time 417 indiana has made an investment in trails, greenways, and bike lanes, which shows that statewide complete streets legislation is not out of reach for hoosiers. complete streets seek to make roadways accessible to all users, which promotes physical activity, economic development, and a more interconnected community. these are parallel goals with indiana’s trails plan. because the trails plan was successful in receiving more funding, this shows that state legislators understand the importance of giving hoosiers the opportunity to be more active, promoting economic growth, and the importance of community. enacting a statewide complete streets law has potential in indiana if the right interest groups and community members speak up, because it will not be as costly to build and difficult to maintain as with trails, greenways, and bike lanes.194 inshape indiana is a state funded program that promotes healthy eating, increasing physical activity, and avoiding tobacco.195 more specifically, inshape offers programs to hoosiers that encourage active lifestyles. some of the programs offered include: ready, set, walk!; 10 in 10 challenge; walk indiana; in shape 150; and summer fit.196 ready, set, walk! simply provides hoosiers with walking logs and encourages participants to log miles for twelve weeks.197 additionally, the program provides motivating and overall fitness tips. in shape 150 encourages participants to meet the 150 minute of moderate aerobic exercise per week goal, by providing new workout plans.198 this eight week program provides suggested exercises, along with healthy recipes.199 having complete streets available in indiana communities could help 194 ind. dep’t of natural res., supra note 187. 195 inshape indiana, http://www.inshapeindiana.org/ (last visited dec. 18, 2014). 196 inshape programs, inshape indiana, www.inshapeindiana.org /207.htm (last visited feb. 28, 2014). 197 programs: ready, set, walk!, inshape indiana, www.inshapeindiana.org/213.htm (last visited feb. 28, 2014). 198 programs: inshape 150, inshape indiana, www.inshapeindiana.org/216.htm (last visited feb. 28, 2014). 199 id. 418 indiana health law review vol. 12:1 encourage more hoosiers to participate in programs like ready, set, walk! and in shape 150. the national complete streets coalition promotes the implementation of complete streets nationally. the coalition is made up of interest groups including: aarp, the national association of realtors, and the american public transportation association.200 with help and support from the national complete streets coalition, over 500 complete streets policies have been implemented across the united states on state and local levels.201 like health by design, the national complete streets coalition provides workshops to communities that focus on foundation laying, policy development, policy implementation, and design considerations.202 with support from organizations like health by design, the national complete streets coalition, and community members, statewide complete streets legislation is a realistic goal that can be achieved in indiana. some may argue that individual communities around the state are doing enough for indiana and that statewide complete streets legislation would be costly to taxpayers. first, only 36% of hoosiers have access to complete streets currently, which despite its low number, is a step in the right direction. however, localities alone cannot implement sufficient changes statewide to adequately combat the current obesity rates. statewide complete streets legislation is needed to change current practice and integrate the needs of all road users into everyday transportation planning and design.203 by enacting legislation, the policy would gradually create a complete 200 national complete streets coalition, who we are, smart growth am., http://www.smartgrowthamerica.org/complete-streets/ who-we-are (last visited jan. 1, 2014). 201 welcome to the national complete streets coalition, smart growth am., http://www.smartgrowthamerica.org/complete-streets (last visited jan. 1, 2014). 202 national complete streets coalition, schedule a workshop, smart growth am. http://www.smartgrowthamerica.org/completestreets/get-help/workshops (last visited jan. 1, 2014). 203 health by design, supra note 71. 2015 combating obesity one step at a time 419 network of streets that serve all hoosier users.204 in the long term, this is more cost effective, because retrofit projects are always more expensive than doing it right the first time.205 when indianapolis implemented its complete streets ordinance, there was increased spending of approximately 5% of the overall project to add sidewalks and bike lanes.206 even though a small increase in spending occurred, the overall benefits outweigh these costs. complete streets provides for improved safety, which reduces the number or injuries and fatalities that prove costly.207 some additional benefits include: the potential for economic development, opportunities for increasing physical activity, reduced traffic congestion, improvements in air quality, and a comprehensive, integrated transportation system.208 specifically increasing physical activity and improving air quality reduces costs in preventable health care for both individuals and the state. indiana’s obesity-attributable health care spending in 2008 was estimated at $1.9 billion or $435 per adult and is expected to increase to high as $7 billion or $1484 per adult by 2018.209 studies have shown that increasing physical activity can lower health care costs, as people become healthier by staying active. even if there are some increased costs with a statewide complete streets policy, the state could save much more in obesity related and overall health care spending. other opponents argue that including bike lanes and making streets “complete” takes away from accommodating motorists, who are the predominant users of the streets. they additionally believe that making streets available to all users causes confusion for motorists. both of these arguments are weak and seek to support the status quo. if streets were made complete, more people would have the 204 id. 205 id. 206 we have a complete streets ordinance in indianapolis!, supra note 89. 207 id. 208 id. 209 ind. state dep’t of health, supra note 50. 420 indiana health law review vol. 12:1 opportunity to use other methods of transportation than solely using automobiles. even if drivers are not used to bike lanes, implementing them into the current streets requires drivers to be more vigilant and share the road. the more that bike lanes are available, the less “confused” drivers will be by seeing the lanes and the bicyclists on the road as well. the cost of complete streets is incorporated into budgeted transportation costs because complete street features are only required when streets are newly built or reconstructed.210 many states across the country are still implementing complete streets policies, despite fiscal constraints. some successful policies have achieved implementation within the context of the existing transportation budget, sometimes even saving the state money.211 further, complete streets policies make transportation projects more popular, which helps gain support for more transportation funding.212 when minnesota conducted its feasibility study for a statewide complete streets policy, it found that the policy would not significantly increase cost, even while providing valuable safety benefits.213 the california state department of transportation found that any additional costs of a complete streets policy would be negligible and outweighed by the overall benefits.214 these are just two examples of statewide policies that have not found complete streets policies to be overly expensive and burdensome on the state department of transportation’s budget. additionally, previous research suggests that if hoosiers have more opportunities to be physically active, obesity and obesity related diseases will likely not increase or even decrease. the health care costs savings would be significant and the positive health implications would be 210 nat’l policy & legal analysis network, supra note 161. 211 smart growth am., costs of complete streets, envtl. & energy study inst., http://files.eesi.org/cs-costs-2-2.pdf (last visited dec. 18, 2014). 212 id. 213 id. 214 id. 2015 combating obesity one step at a time 421 immeasurable. not only have complete streets been demonstrated to be effective in promoting physical activity and decreasing rates of obesity, but they also have the potential to improve community connectedness overall, resulting in happier communities where people enjoy living and working. iv. conclusion the data shows that obesity is an epidemic sweeping the nation, with no exception in the state of indiana. if these alarming statistics are going to improve in the future, the state must implement policies that will help citizens increase physical activities and eat healthier in their daily lives. the experiences of other states that have already implemented complete streets legislation suggest that adding such measures in indiana may positively impact obesity by providing safe travel options for hoosiers, encouraging greater opportunities to increase the number of pedestrians and bicyclists in our communities. these changes in turn may lead to increased numbers of hoosiers meeting the 150 minutes per week of vigorous physical activity or the 300 minutes per week requirement of moderate physical activity, helping individuals lose weight and lower bmi.215 unfortunately, if statewide complete streets legislation is again rejected, hoosiers are more likely to be plagued by the detrimental effects of obesity and the related care costs that go along with the epidemic. as dr. gregory larkin predicted, our health care spending on obesity could skyrocket to $7 billion or $1484 per adult by 2018 if indiana fails to take action.216 communities, families, and employers will all be negatively affected with no statewide plan to reduce rates of obesity in indiana. enacting complete streets legislation is a form of prevention that may help slow the increasing rates of obesity in indiana and over time slowly decrease these staggering numbers. 215 hensrud, supra note 26. 216 ind. state dep’t of health, supra note 50. 422 indiana health law review vol. 12:1 local trends of implementing complete streets in indiana and the success of the trails, greenways, and bike lanes plan demonstrate to the general assembly that the state is prepared to move forward with legislation that will reap the health, social, and fiscal benefits that other states are already enjoying. however, this effort must be supported by citizens, community groups, and indiana noting that if it is to succeed. these people must convince the general assembly that indiana is tired of ranking as one of the most obese states in the nation, ready to address this epidemic with open arms, and show lawmakers that complete streets is an essential stride for the future of healthy hoosiers. one step at a time, indiana is ready to complete its streets and help hoosiers become more physically active now and in the future. davidkorn david kom (b.a., sci, m.d., cl, harvard university) is the first vice­ provost for research at harvard university as well as professor of patholo­ gy at harvard medical school, positions he assumed on november 15, 2008. prior to joining harvard, dr. kom had served as the chief scientific officer of the association of american medical colleges (aamc) in washington, d.c. since january 15, 2007, and before that as the senior vice president for biomedical and health sciences research at the asso­ ciation since september 1, 1997. dr. kom served as carl and elizabeth naumann professor and dean of the stanford university school of medicine from october 1984 to april 1995, and as vice president of stanford university from january 1986 to april 1995. previously, he had served as professor and chairman of the depart­ ment of pathology at stanford, and chief of the pathology service at the stanford university hospital, since june 1968. dr. kom has been chair­ man of the stanford university committee on research; president of the american association of pathologists (now the american society for inves­ tigative pathology), from which he received the gold-headed cane award for lifetime achievement in 2004; president of the association of pathology chairman; a member of the board of directors and of the executive com­ mittee of the federation of american societies for experimental biology; and a member of the board of directors of the association of academic health centers. dr. kom was a founder and chairman of the board of directors of the cali­ fornia transplant donor network, one of the nation's largest organ pro­ curement organizations. more recently, he was a founder of the association for the accreditation of human research protection programs, a nonprofit corporation created to enhance and standardize the protection of human participants in medical and other·scientific. research. he has been a member of the institute of medicine of the national academies of science since 1989 and has served on numerous nas and 10m committees; dr. kom was a founder of the 10m's clinical research roundtable and is cur­ rently the co-chair of the nas committee on science, technology and law. in 1996-97 dr. kom chaired a special subcommittee of the science board of the food and drug administration to review the fda's intramu­ ral research program, for which he received the commissioner's special citation and the harvey w wiley medal. from 1984 to 1991 he served as chainnan of the national cancer advisory board, a position to which he was appointed by president reagan. dr. kom is a fellow of the aaas and has served on its council, and he was a member of the university grants committee of hong kong from 1998-2004, where he was chairman of the medical subcommittee. dr. kom served on the boards of directors of the stanford university hos­ pital from october 19~2 to april1995, the children's hospital at stanford from october 1984 to its closure, and the lucile salter packard children's hospital at stanford from october 1984 to april1995. he was a member of the board of directors of the california society of pathologists from 1983-86. dr. kom has been a member of the editorial boards of the american jour­ nal of pathology, the journal of biological chemistry, and human pathol­ ogy, and for many years was an associate editor of the latter. he has sat on many society councils and boards. he has written many scientific articles, ranging from bacteriophage biochemistry and genetics to the biochemistry and molecular biology of dna replication in human cells. during the past 2 decades his work, writings, and lectures have focused on issues of aca­ demic values and integrity, research integrity, health and science policy, and financial conflicts of interest in academic medicine. financial conflicfs of interest in academic medicine: whence they came, where they went david kom, m.d. • i. introduction ................................................................................... 3 it. what is a confuct of interest? .................................................. 5 lll. financial conflicts of interest: whence they came ............ 6 n. the academic community responds ......................................... 13 a. accreditation program for human research ............................ 13 b. aamc task force on clinical research ................................... 14 v. financial confucts of interest, where they went .......•..•. 19 vi. enter the national institutes of health (nlll) and the diihs oig ........................................................................ 21 vll. the academic community shoots itself in the foot ............ 23 viti. new actors enter the fcoi mix ................................................ 25 ix. again, the academic community responds ............................ 28 x. fcois in medical education ....................................................... 28 xi. the scientific basis of influence and reciprocity: a symposium ...................................................................................... 32 xll. financial confucts of interest: where they are, where we are ............................................................................... 34 xlll. nih issues an advanced notice of proposed rule making {anprm) followed by an nprm ................................ 38 xn. concludingremarks ................................................................... 39 i. introduction conflicts of interest are endemic in all professions, and the professions have over time developed normative behavioral and transactional processes to prevent or mitigate the effects of conflicts of interest from unduly influ­ encing professional judgments, choices, and decisions. consider the scien­ tific method itself, as it evolved nearly five hundred years ago, demanding that communications of research findings provide complete descriptions of materials and methods used as well as the data obtained, in order to enable other scientists "skilled in the art" to test the reproducibility of the results, to build upon them or refute them. perhaps it was because of an innate • david kom, m.d. is the vice provost for research at harvard university and professor of pathology at harvard medical school. on november 5, 2009, the annual mcdonald-merrill-ketcham lecturellndiana health law review symposium was held at indiana university school of law-indianapolis. dr. david k.om was keynote speaker of the event, we are grateful to have this article as an extension of his remarks. some of the topics addressed have been updated by the author since his presentation to capture relevant inter­ vening events. 4 indiana heal til law review [vol. 8:1 sense of human frailty that our forebears agreed both that scientific hypoth­ eses (as opposed, for example, to religious dogmas) must be refutable and scientific observations, reproducible. certainly, sir francis bacon recog­ nized these frailties when he wrote in 1620: the human understanding is no dry light, but receives infusions from the will and affections; whence pro­ ceed sciences which may be called 'sciences as one would.' for what a man had rather were true he more readily believes . . . . numberless, in short are the ways, and sometimes imperceptible, in which the af­ fections color and infect the understanding.1 as i note later in this paper, more than 370 years would elapse before ba­ con's insights would become, in a sense, formally codified by the marriage of traditional economics, erected on the principle ofhomo economicus, the ''rational consumer," with psychology that gave rise to the thoroughly dis­ ruptive discipline of behavioral economics. it is important to recognize that the academy provides no refuge. conflicts of interest, the great majority of which do not, at least directly, involve money, are ubiquitous, indeed inevitable, in academic life, includ­ ing in academic medicine. as i wrote a decade ago: successful. scientists cannot be totally dispassionate about their work, nor can academic medical research­ ers be immune from the jumbled and often intense conflicting pressures that envelop them. these pres­ sures, not primarily financial, include the desire for faculty advancement, to compete successfully and re­ petitively for sponsored research funding, to receive accolades from professional peers and win prestigious research prizes, and to alleviate pain and suffering. the last, which likely first led the researcher to choose an arduous academic career and then persist despite its demands, uncertainties, and disappoint­ ments, may be the most enduring pressure of all. all of these nonfinancial pressures may generate conflicts by creating strong bias toward positive results, and all of them may more powerfully influence faculty be1. francis bacon, novum organum; with other parts of the great instauration 44 (peter urbach & john gibson eds., 1994). 2011] financial conflicts of interest in academic medicine 5 havior than any prospect of financial enrichment.2 importantly, these kinds of pervasive academic conflicts are of little note or interest to the public. in contrast, financial conflicts of interest ("fcois") are well understood by the several different publics that academic medicine serves, and during the past three decades, recurring outbreaks of attention to fcois in academic medicine from the media, congress, and the administration have generated the increasing public concern that academic medicine now faces. my purpose in this presentation on fcois in academic medicine is to provide a context to help the reader better understand from whence they came, where they went, and why they continue to be of such concern to the public and so vexing to academic medical institutions and their faculties, struggling to balance mixed public messages and conflicting public expec­ tations. ii. what is a conflict of interest? there are many defmitions of conflict of interest from which to choose, but the one i prefer is that offered in a recent report from the insti­ tute of medicine ("10m"), one of the three components of the u.s. national academies of science: "a conflict of interest is a set of circumstances that creates a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. "3 a "primary interest" for academic medical scientists would be to protect the well-being of their patients and the integrity and credibility of their research. a "sec­ ondary interest" could be any of the examples listed above, but for the pur­ pose of this manuscript, a secondary interest will be financial. thus, an academic physician may be receiving payments from a pharmaceutical or medical device company that depends on the magnitude of his or her usage of the company's products. an academic medical scientist may also have a direct financial interest ranging from equity in a start-up company created from the discovery or from consulting or speaking payments from a vendor, in the outcome of the experiment, whether bench research or, for example, an early-phase clinical trial. what is appealing about the 10m definition is its clarity that a conflict of interest ("col"), financial or not, is a situation and not per sea judgment about the character or actions of an individual. when attempting to address fcois in a university, medical school, or teaching hospital, helping faculty and other personnel to understand this point becomes exceedingly im2. david kom, conflicts of interest in biomedical research, 284 jama 2234, 22342237 (2000). 3. conflict of interest in medical research, education, and practice, institute of medicine 46 (national academies press, 2009). 6 indiana health law review [vol. 8:1 portant, albeit very difficult. to this point, and recalling my quote from francis bacon, the noted behavioral economist, professor george loewen­ stein from carnegie-mellon university, has asserted that traditional eco­ nomics assumes that professionalism and cois are asymmetric motives in influencing behavior, and that persons who confront cois are equipped to deal with them rationally.4 behavioral economics posits a more complex model of decision-making, one that includes unconscious motives and other factors outside the control of a purely rational process. biases are viewed as unconscious, or as many neuroscientists, concerned to avoid references to freudian doctrine, would prefer, ''unwitting" or "beneath awareness." iii. financial conflicts of interest: whence they came in the aftermath of world war ii, inspired by the remarkable "path of the war-changing" discoveries (e.g., radar, sonar, napalm, cryptanalysis) from university laboratories working under federal research contracts and informed by the seminal report, science: the endless frontier,5 authored by vannevar bush, who in 1940, while serving as the newly installed presi­ dent of the carnegie institution of washington, had become director of the new federal office of scientific research and development, the federal government made the seminal decision that it had a legitimate role in fund­ ing basic research, and that the funding should flow through universities, where the performance of cutting edge research would be conjoined with the education of future generations of scientists. probably no one precisely foresaw the enormous, world-leading american basic research enterprise that would result, led by what columbia university professor and former provost jonathan cole has described in his new book, the great american university.6 however, some senior academic leaders, especially from pri­ vate universities, were concerned that "getting into bed with the govern­ ment" in this way would have long-term adverse consequences, threatening the academy's zealously protected autonomy and self-governance, and even its academic agenda. in response to these concerns, an agreement was negotiated to create what came to be dubbed the "federal-academic re­ search partnership," under which the universities would retain their exclu­ sive oversight of the conduct of federally sponsored research by their faculty members, while acknowledging the government's right to exercise 4. see the scientific basis of influence and reciprocity: a symposium, 2007 ass'n of am. med. colleges, june 7, 2007, (hereinafter symposium) available at https://services. aamc.orglpublications/index.cfm?fuseaction=product.displayform&prd _ id=215&prv _id=26 2. 5. vannevar bush, science: the endless frontier (1945), available at http:/ /www.nsfgov/od/lpa/nsf50/vbushl94s.htm. 6. jonathan r. cole, the great american university: its rise to preeminence, its indispensable national role, why it must be protected (20 1 0). 2011] financial conflici's of interest in academic medicine 7 due diligence that federal research funds were expended appropriately. from this agreement derived the "assurance mechanism" under which uni­ versities had only to "assure" federal research sponsoring agencies that they had in place dutifully enforced policies and procedures to enable their com­ pliance with federal requirements. it was doubtless anticipated at the time that these requirements would remain relatively few and directed essentially exclusively at oversight ofthe expenditures of federal funds. this anticipa­ tion held true for about thirty years. but beginning in the mid-1970s and continuing into the 1980s, there were an unfortunate series of episodes of scientific misconduct or fraud that involved national institutes of health-funded biomedical research (''nih"), some of which involved research on human subjects. these epi­ sodes became highly publicized, and they attracted the attention not only of the nih, but also of the cognizant congressional committees, especially in the house of representatives. in a few of these cases, the perpetrators were discovered to have substantial fcois. a seemingly endless series of acerbic congressional hearings ensued, beginning with the oversight and investiga­ tions subcommittee of the house science committee in 1981, during which the unfortunate conjunction of fcois with scientific fraud became ever more firmly cemented in media coverage and the minds of key congress­ persons. arguably, the most compelling embodiment of this conjunction was the 1990 report from the house committee on government operations, now the house committee on oversight and government reform,7 which catalogued the misconduct cases that had surfaced to date, entitled are sci­ entific misconduct and conflicts of interest hazardous to your health? the conviction that fcois lead to research misconduct and, thus, to adverse effects on public well-being persists in the minds of the public to this day. put most simply, fcois are bad; they lead to bad science; and bad science can result in harm to the public. the cumulative hearings led to two major congressional actions that would forevermore alter the painstakingly negotiated terms of the federal­ academic research partnership and the relationship of academic institu­ tions and their faculty to federal research sponsors: the federal government would interpose itself into the oversight of the conduct of federally spon­ sored research by faculty investigators. the first action was contained in the 1985 reauthorization of the public health act,8 containing the funda­ mental enabling legislation for the nih, when congress directed the public health service ("phs") to write a regulation defining and addressing mis­ conduct in federally sponsored research. this directive, as expected, stimu­ lated great concern among the leadership of academic research institutions 7. see h.r. rep. no. 688-101 (1990). 8. health research extension act of 1985, pub. l. no. 99-158, §493, 99 stat. 820 (1985). 8 indiana health law review [vol. 8:1 and professional scientific societies, and during the next nearly four years, there were difficult and often heated interactions between academic leader· ship and the phs. in the forge of these interactions, the academic commu· nity came together on the goal of limiting the scope of the federal interest in research misconduct as much as possible, and this strategy proved success· ful. the final regulation issued in 19899 was essentially confined to three behaviors that are relatively unambiguous and universally condemned across the community of scholars as research misconduct: fabrication, falsi· fication and plagiarism, commonly referred to as "ffp." the regulation also established a formal process of institutional response to allegations of research misconduct, and it established in the phs a new office of scien­ tific integrity ("osi"), charged to oversee these institutional processes, re­ view the institutions' final reports, conclusions and disciplinary actions, and pass judgment on the integrity, adequacy, and conclusions of the institu­ tional processes. shortly after the regulation was issued, the national sci­ ence foundation (''nsf"), the second largest federal fonder of academic scientific and engineering research, adopted its own misconduct regulation, which closely follows that of the phs.10 admittedly, ffp is limited. as the academic leadership desired, the rule does not purport to embrace the universe of misdeeds that university policies might properly consider "research misconduct," (e.g., authorship disputes, harassment of vulnerable members of research teams, sabotage of competitors' research, etc.). during the nearly four years of negotiation, and continuing through much of the 1990s, there were repeated efforts by federal officials and by clusters of academicians to broaden the scope of the federal rule. final resolution did not occur until 2000, when the office of science and technology policy ("ostp") in the executive office of the president issued a notification of final policy11 on research misconduct that made important clarifying changes in the language of the 1988 regula­ tion and reaffirmed the limitation of the rule's scope to ffp. with its pub­ lication in the federal register, the "final policy" became applicable to all federal agencies that sponsor research, compliance with the rule is man­ aged by the assurance process. each year, research institutions must assure the government that they have in place dutifully enforced misconduct poli­ cies and procedures that are compliant with the regulation, and provide in­ formation about the number of allegations of misconduct they received 9. public health service, department of health and human services, grants, policies of general applicability, 42 c.f.r. §§ 50.101-607 (2011). 10. public welfare, regulations relating to public welfare, national science founda­ tion, research misconduct, 45 c.f.r. § 689 {2010). 11. office of science and technology policy, executive office of the president; fed­ eral policy on research misconduct; preamble for research misconduct policy, notification of final policy, 65 fed. reg. 76260 (dec. 6, 2000), available at http://www.sc.doe.gov/ misconduct/finalpolicy.pdf. 2011] financial conflicts of interest in academic medicine 9 during the prior year, and the status of these allegations in the sequential institutional response procedures mandated by the rule. in 1988, in harshly critical, many called them abusive, congressional hearings, led by congressman john dingell, then chairman of the over­ sight and investigations subcommittee of the house energy and commerce committee, the matter was first raised of ordering the department of health and human services ("dhhs") to write a regulation addressing :tt::ois in academic and other institutions that receive research and training grants, primarily from the nih. although formal authorizing language was not to appear until 1993,12 the dhhs responded to mr. dingell, and the battle lines with academe were redrawn. difficult and often contentious negotia­ tions would go on, and trial balloons would be launched and shot down, for nearly seven years before the phs finally issued its regulation, entitled to ensure the objectivity of research, in 1995.13 it is noteworthy that the phs remains to this day the only federal agency to have its own :tt::oi regulation. however, similarly to its action with respect to the phs research miscon­ duct regulation, the nsf very soon after issued its own essentially identical :tt::oi guidance. 14 once again, the government was interposing itself into the oversight of the conduct of faculty investigators, and once again, the leadership of academic institutions and scientific societies fought to ensure that the regulation would be as minimally intrusive as possible. and the 1995 rule was indeed light-handed! in negotiating this rule, both the government and the academy were treading on unexplored terrain. at that time, there were no accepted land­ marks or boundaries, such as specific magnitudes of related financial inter­ ests or specific circumstances generally agreed to create problematic :tt::ois demanding institutional intervention, nor were there processes empirically demonstrated to be effective in dealing with :tt::ois. neither was there any consensus about the relative importance of :tt::ois as compared to the pleth­ ora of non-financial cois that i earlier addressed in leading faculty re­ searchers to problematic behaviors, including research misconduct. in this domain, there was no ready equivalent offfp. as described earlier, a col, or :tt::oi, is a set of circumstances that creates a risk (often conditioned as an undue risk) of undue influence on professional decisions or actions. the existence of an :tt::oi is ultimately a matter of third-party (the "reasonable observer'' so favored in law) perception or judgment, and perceptions and 12. nih revitalization amendments of 1990, h.r. 5661, § 151 (1990) (containing authorizing language but did not become law); nih revitalization amendments of 1992, h.r. 2507, § 154 (1992) (enacting authorization, however, both the fda and the nih were already well along in drafting their respective rules). 13. see 42 c.f.r. §§ 50.101-607 (2010); 45 c.f.r. § 94 (2010). 14. national science foundation, office of budget, finance & award management, national science foundation grant policy manual, section 510 (2005), available at http:/ /www.nsf.gov/pubslmanuals/gpm05 _131/gpm05 _13l.pdf. 10 indiana heal1h law review [vol. 8:1 judgments are awfully hard to regulate. in the end, after nearly seven years of heated deliberations and several rejected federal proffers, the government and academic leadership agreed to define, entirely arbitrarily, specific mag­ nitudes of financial interests that relate to an investigator's federally funded research as "significant financial interests" ("sfis") (thus, $10,000 or more income in a year from, or five· percent equity in, a publicly traded company). the institutions would require faculty members annually and whenever they submitted a federal research proposal to identify and dis­ close such related sfis, and if the institution determined that the sfi creat­ ed a conflict with the proposed research project, it would deal with the fcoi by eliminating, reducing, or managing it before the conflicted investigator could begin spending funds from an awarded research grant. the regulation required only that the institution notify the funding agency (e.g., the nih) that it had identified an fcoi related to a specific research grant and had dealt with it before permitting expenditure of the awarded funds. no fur­ ther details were required, and although the regulation did· empower the agency to request additional information, experience showed that this would occur infrequently. during these prolonged negotiations, public attention to fcois in bi­ omedical research had begun to wane, but the relative quietude ended ab­ ruptly in the latter 1990s, when a series of scathing federal reports focused attention on research involving human subjects and raised questions about how effectively the well-being of these research subjects was being protect­ ed under the extant federal regime by academic investigators and their insti­ tutions. first out of the gate was the report of a federal commission15 chaired by renowned ethicist, ruth faden, a professor and dean in the johns hopkins university school of public health, that had been charged with investigating secret experiments conducted by the u.s. military during wwii on u.s. civilian populations. the findings were damning and widely publicized. the commission, concerned by their findings of potentially dangerous and large-scale exposures of non-consented individuals to irradi­ ation and microbial pathogens, decided toward the end of their investigation to conduct a "quick and dirty" examination of the then current state of "in­ formed consent" by collecting informed consent documents from several dozen major research institutions. from their review, the commission con­ cluded the informed consent process was seriously defective. there followed three highly critical reports, two from the dhhs of­ fice of inspector general ("010")16 and one from the then general ac15. advisory commtitee on human radiation experiments, final report of the advisory committee on human radiation experiments (u.s. gov't printing office, 1995). 16. off. of the inspector gen., dep't of healtii and human serv., oei-01-9700193, institutional review boards: a time for reform (1998), available at http://oig.bhs.gov/oei/reports/oei-01-97-00193.pdf (hereinafter institutional review 2011] financial conflicts of interest in academic medicine 11 counting office ("ga0")/7 all ofwhich questioned the robustness and ef­ fectiveness of academic institutions' oversight of and diligence in protect­ ing the wellbeing of their human research subjects, and the adequacy of their support for their institutional review boards ("irbs"). applicable federal regulations18 require that all proposed research on human subjects that is not defined in the regulations as "exempt" must be reviewed, ap­ proved, and overseen by an irb. prospective research subjects must give their "informed consent" willingly and without coercion to participate in the research. the regulations and extensive subsequent guidance from the fed­ eral oversight bodies (during the 1990s, the office of protection from re­ search risks [("oprr") in nih]; since 2000, the office of human research protections ("ohrp"), an independent component of the phs) address in great detail what constitutes an acceptable informed consent pro­ cess and its documentation. the irb closely examines research proposals and informed consent documents to determine whether any of the investiga­ tors have fcois, whether the research is being performed to contribute to general knowledge (i.e., to be published), whether experimental risks have been appropriately minimized and adequately explained to prospective sub­ jects, and whether the research will necessarily expose the subjects to more than minimal risk, and, if so, whether specific modifications of the protocol or protective measures must be implemented before the research can pro­ ceed. the primary duty of the irb system is to protect the well-being of human research subjects and ensure that proposed research is conducted in conformity with the highest ethical principles as well as scientific standards -yet one of the oig reports proclaimed that the "[irb system] is in jeop­ ardy."t9 these federal reports raised a new and pivotal question, previously unaddressed, about the ability of irbs institutional bodies to fulfill their obligations in circumstances in which their institutions themselves have financial interests in proposed research involving human subjects. all of the mishaps noted earlier, which had so riveted the attention of the govern­ ment and the media on fcois in federally sponsored research, had involved the fcois of individual researchers. and the 1995 fcoi regulation ad­ dresses only individual fcois. but now, in the late 1990s, for the first time, the fmancial interests of the institutions themselves of the universities, the boards]; off. of the inspector gen., dep't of health and human serv., oei-9700197, protecting human subjects: status of recommendations (2000), available at http:l/oig.hhs.gov/oei/reports/oei-01-97-00197 .pdf. 17. u.s. general accounting office, gao/hehs-96-72, sciennfic research: continued vigilance critical to protecting human subjects (1996), available at http://www.gao.gov/archive/1996/he96072.pdf. 18. the phs, as well as the scientific community, commonly refers to 45 c.f.r. § 46 (2010) as the "common rule" because of its adoption by seventeen federal agencies that sponsor human subjects research; the exception is the fda, which has its own variant of the common rule in 21 c.f.r. § 50 (2010). 19. institutional review boards supra note 16, at 4. 12 indiana health law review [vol. 8:1 medical schools, the teaching hospitals and the fcois they could generate, institutional fcois, had been placed squarely into the public spotlight. re­ call that under the terms of the federal-academic research partnership the government had delegated to the academy the principal, if not exclusive, authority to oversee faculty conduct of federally sponsored research, but if the academy had its own financial interests in that research, did that not generate institutional fcois? and in the presence of such institutional fcois, how could the public be certain the institutional processes and bod­ ies that implemented and assured institutional oversight were not being bi­ ased and could still be trusted? the clinton administration early in its second term (october 1995) had established the national bioethics adviso­ ry commission (''nbac") to examine the many ethical issues related to human subjects research, and in one of its several reports the commission explicitly called for enhanced institutional management of institutional, irb, and individual fcois. 20 adding to the turmoil of the late 1990s and early 2000s, the heretofore low-key oprr became unusually and publicly active by suspending human subjects research, seriatim, in more than a dozen major research universities for largely technical violations of informed consent and irb procedures. one suspension, at the university of colorado, lasted nine months. anoth­ er, at duke university, sparked a time magazine cover showing a human research subject cowering in a rodent cage under the banner: how medical testing has turned millions of us into human guinea pigs.21 widespread publicity intensified public and congressional attention to problems in uni­ versities' oversight of human subjects research. then, between 1998 and 2001, three research subjects died, respectively, at the university of roch­ ester, the university of pennsylvania, and then, johns hopkins university?2 of these deaths, one in particul~3 attracted extraordinary notice and con­ gressional interest: that at the university of pennsylvania of a teenager 20. see 1 national bioethics advisory commission, research involving human biological materials: ethical issues and poucy guidance: report and recommendations (1999), available at http://bioethics.georgetown.edu/nbaclhbm.pdf; see also 2 national bioethics advisory commission, research involving human biological materials: ethical issues and poucy guidance: commissioned papers (2000), available at http://bioethics.georgetown.edu/nbaclhbmll.pdf. 21. michael d. lemonick & andrew goldstein, at your own risk, time, apr. 22, 2002, available at http://www.time.com/time/magazine/0,9263, 7601 020422,00.html (dis­ playing cover of magazine issue). 22. vera hassner sharav, human experiments: a chronology of human research, alliance for human research protection, http://www.ahrp.org/history/chronology.php (last visited feb. 2, 2011). 23. see id.; gene therapy: is there oversight for patient safety?, before the s. comm. on health, education, labor and pensions, subcomm. on pub. health, 106 cong. (2000) (statement of amy patterson, m.d., dir. of the off. of biotechnology activities at the nat'l inst. of health) available at http://www.hhs.gov/asl/testify/t000202c.html; see also bioethics: gene therapy business: the tragic case of jesse gelsinger, news weekly, aug. 12, 2000, available at http://www.newsweekly.com.aularticles/2000aug12_bio.html. 2011] financial conflicts of interest in academic medicine l3 named jesse gelsinger, who was participating in an early-phase gene thera­ py trial that had received all necessary university approvals, as well as ap­ proval by the fda for use of the investigational ·new drug. but examinations ex post revealed that the research team had both taken and not taken actions in violation of fda requirements, and determined the pres­ ence of both individual and institutional fcois. it is important to note that extensive investigations of gelsinger's death by the fda and by the uni­ versity, which convened a high-level commission of outside experts tore­ view the facts of the case, never established any direct linkage of the fcois to this tragedy. nevertheless, in the perfervid atmosphere of the late 1990s, the association was enough to stimulate heated calls for congressional and administrative action to strengthen oversight of human subjects research. iv. the academic community responds a. accreditation program for human research during the later 1990s, professional organizations representing the leadership of universities and academic medicine became understandably concerned about the furor over human subjects research, especially after the gelsinger tragedy, and the possible harmful effects of new legislation or regulation enacted in such a frenzied and emotional climate. the governing board of the nonprofit professional development organization public re­ sponsibility in medicine and research ("prim&r''), dedicated to promot­ ing ethical behaviors in human and animal research, had begun to deliberate the wisdom and realism of establishing a de novo accrediting body for hu­ man research protection programs.24 i became aware ofprim&r's delib­ erations while serving (1997-2008) as senior vice president for biomedical and health sciences research at the nonprofit association of american medical colleges ("aamc") in washington, dc, and initially rejected the idea as wishful. all academic institutions, but especially medical schools and teaching hospitals, undergo a variety of recurrent, separate accreditation visits and generally find them very burdensome and expensive, and of une­ ven value. but as the clamor continued to intensify, i became convinced that the idea of creating an independent entity to accredit academic human research protection programs had merit and could be a very powerful way for the academic community to demonstrate its respect for the public con­ cerns, as well as its own concerns and resolution to correct its perceived shortcomings. with approval from the aamc leadership and governance and full cooperation from prim&r, i succeeded during the next eighteen 24. mission, values, & vision, prim&r, pubuc responsffiili'iy in medicine and research, hup://www.primr.org/ aboutus.aspx?id=4463&ekmensel=c580fil7b _ 68 _ 0 _ 4463 _1 (last visited jan. 23, 2011 ). 14 indiana health law review [vol. 8:1 to twenty months in enlisting the participation of five additional leading nonprofit organizations that represented the major private and public uni­ versity presidents and senior administrators, the life sciences and social and behavioral sciences faculties, and a politically influential umbrella organi­ zation whose membership includes all of the patient disease advocacy groups and much of the medical vendor industry. these recruits were: the association of american universities ("aau"), the national association of state universities and land grant colleges (''nasulgc"), the council on government relations ("cogr"), the federation of societies for experi­ mental biology ("f aseb"), the consortium of social science organiza­ tions ("cossa"), and the national health council ("'nhc"), all of whom agreed to support the concept and contribute to the start-up capital needed to launch the venture. importantly, the pharmaceutical industry's dc-based lobbying organization ("phrma") was also fully supportive of the initia­ tive and agreed to match the aamc's share of the working capital, but phrma's leadership decided, wisely, it was best that it not be involved or publicly associated with the new organization. with this broad base of sup­ port, the association for the accreditation of human research protection programs ("aahrpp") opened its doors in the fall of 2001, with the seven founding organizations serving as trustees, but with an impregnable firewall between them and the operations of the new entity, which were overseen by its executive director and an independent board of directors. after a diffi­ cult beginning, in large part due to the academy's aversion to accreditation as well as a muting of public concerns, aahrpp has become a gratifying success, winning plaudits from both congress and the administration; at the time of this writing, nearly 1,100 entities universities, teaching hospi­ tals, va hospitals, community hospitals, independent irbs and clinical research organizations ("cros''), a major pharmaceutical company, and a growing number of academic institutions in asia and europe have been accredited, 25 and institutions' attention to and, importantly, their invest­ ments in their human research protection programs have increased substan­ tially. human research protection programs in academia and many in the private sector are far more robust, better supported, and deservedly more credible today than they were a decade ago. b. aamc task force on clinical research in the fall of 1999 the aamc leadership decided to form what was to become its first task force on financial conflicts of interest in clinical research, which fell under the purview of my team and held its first meet25. press release, ass'n for the accreditation of human research protection pro­ grams, inc., aahrpp has accredited 223 (dec. 16, 2010), available at http://www.aahrpp .orglwww.aspx?pageid=383. 2011] financial conflicts of interest in academic medicine 15 ing in the spring, 2000. the task force had a roster of twenty-eight mem­ bers representing academic medicine, the biopharmaceutical industries, bio­ ethicists, university general counsels, the presidents of three major disease advocacy organizations, distinguished journalists no longer engaged in re­ porting, and a newly retired congressman who had chaired the nih appro­ priations subcommittee of the house energy and commerce committee. the committee was chaired by william danforth, md, who had a long and distinguished career as vice-chancellor of the washington university in st. louis ("wustl") academic medical center, then chancellor and finally chairman of the board of wustl.26 the task force was to work for more than eighteen months and produced two reports: the first, in decem­ ber 2001, addressed individual fcois, while the second, in october 2002, addressed institutional fcois.27 i digress to make an important point, to which i shall return later in this manuscript when i address what i have called the "challenge of public expectations"28 that plays out most intensely in the domain of academic medicine. as noted, seven members of the task force were not associated with universities or academic medical institutions, or with industry, and at the first meeting of the task force it became surprisingly clear how little our "civilian members" understood of the processes required in our socio­ economic system to bring a scientific discovery to pubic benefit. especially surprising were the disease advocacy leaders, who devote their lives to ad­ vocating for more money for nih research on the diseases of interest to their members (e.g., cancer, mental illness, aids, etc.). they seemed not to understand that with the notable exception of the department of defense, the federal government funds research but not development, which is the 26. about wustl: facts, history and traditions: william h. dariforth, washington unnersity in. st. louis, http://www.wustl.edu/about/facts/chancellors/danforth.html (last visited jan. 23, 2011). 27. see l ass'n of american medical colleges, task force on financial conflicts of interest in clinical research, protecting subjects, preserving trust, promoting progress: policy and guidelines for the oversight of individual financial interests in human subjects research (200 1 ), available at https:/ /www.aamc .org/download/75302/data/firstreport.pdf; 2 ass'n of american medical colleges, task force on financial conflicts of interest in clinical research ii: principles and recommendations for oversight of an institution's financial interests in human subjects research (2002), available at https://services.aamc.org!publications/showfile.cfm ?file=version24.pdf&prd _id= 1 06&prv _ id= 117 &pdf_ id=24. because the aamc' s prove­ nance is limited to academic medicine, and to avoid political friction with national organiza­ tions that represent university presidents, we limited the scope of these and following reports, directed to aamc members medical schools, teaching hospitals, and their faculty members, by focusing them on human subjects research, even though such research takes place elsewhere in a university, for example, in the social and behavioral sciences. notwith­ standing, the reports and their major recommendations, with few technical exceptions, are equally applicable to all academic research and scholarship. 28. see david kom, the challenge of public expectations, boston review (may/june 20 10), http:/ /bostonreview.net!br35 .3/kom.php. 16 indiana health law review [vol. 8:1 province of the private sector, and that to develop tangible public benefits from scientific discoveries requires that there be an "active interface" be­ tween scientists and their institutions with private sector agents. once these members accepted the need for the interface, however, they still could not understand "why money has to change hands," arguing that faculty are well paid and engage in professions that bring them great satisfaction and pleas­ ure. other committee members reminded that we are a capitalist economy and discussed the requirements of the bayh-dole act, 29 the expectations of venture capitalists, and the fact that many faculty inventions are far up­ stream and absolutely require the inventors • continued engagement to move them into the developmental pathway, but i was never certain that we fully convinced our doubters. the first task force report proved to be extraordinarily influential and has guided the development of individual fcoi policies in many of our na­ tion's medical schools and major teaching hospitals. the report established as its core principles that faculty members must disclose to their institution their related fcois; that institutions must ensure a high standard of review of these disclosures; and the rebuttable presumption that a faculty member with a related financial interest deemed to be "significant" and to create a fcoi should not be permitted to perform research on human subjects?0 this presumption, however, was not an absolute prohibition and could be challenged by the faculty member's demonstration of "compelling circum­ stances.'.31 although the task force did not try to craft a definition of "compelling circumstances," it intended that they be evaluated by consider­ ing the nature, magnitude, and "relatedness" to the research of the financial interest, and the degree of risk raised by the interest to the wellbeing of hu­ man subjects and the integrity of the proposed research.32 it is my personal view that circumstances should be judged ''compelling" only if the research could not otherwise be conducted as safely and effectively. rigorously ap­ plied, this would be a very high standard indeed that would permit relative­ ly few challenges to prevail. the approach recommended by the task force was intended not to be formulaic and built around "red lines," but rather to require institutions to perform stringent risk-benefit assessments, much like those routinely performed by an irb. 33 however, some institu­ tions have concluded that this approach would be too burdensome and ex­ pensive and have chosen to default to less administratively onerous approaches structured around absolute prohibitions. the task force's second report addressed for the first time the prob29. government patent policy act of 1980, pub. l. no. 96-517, 94 stat. 3015 (dec. 12, 1980). 30. see 1 ass'n of american medical colleges, supra note 27. 31. idat1. 32. !d. 33. see generally, id. 2011] financial conflicts of interest in academic medicine 17 lem of institutional fcois in human research.34 in contrast to individual fcois, with which the academic community had had more than a decade of experience, the first publication in a major professional journal to address institutional fcoi, of which i am aware, appeared in the new england journal of medicine in 1994.35 the committee was aware that they were stepping onto unplowed ground without guiding precedents, and so it is that the title of the fust report chose "policy and guidelines for oversight ... " while the second was framed more cautiously as "principles and recom­ mendations for oversight .... "36 the task force report proffered a definition of the problem: an insti­ tutional fcoi exists whenever the financial interests of the institution, or of an institutional official or committee, create a risk of unduly influencing institutional processes for the review, conduct, or oversight of [human sub­ jects] research.37 the task force articulated as a core management princi­ ple that institutional administrative functions and responsibilities related to the oversight of [human subjects] research should be cleanly separated from those related to financial and investment management and technology li­ censing, and then proceeded to build the institutional report around the basic administrative structures and processes articulated in the individual policy, including the "rebuttable presumption," simply increasing the threshold amounts of income or investment that would be deemed to be "significant." this report has had utility in guiding institutional fcoi poli­ cies in academic medical institutions, but aside from separation of their fi­ nancial and academic administrative oversight structures, the report's recommendations have been widely shunned by university presidents as too unwieldy and intrusive. it is my personal opinion, nearly a decade later, that the recommended approach could only be feasible in institutions in which the prevalence of institutional fcois was low. but in today's major research universities and academic medical centers, with their robust and aggressive technology transfer programs and pursuit of research partner­ ships with industry, the prevalence of such potentially conflicting institu­ tional financial interests is no longer low. i earlier described the federal-academic research partnership, the delegation of oversight of the conduct of research to the universities, and the "assurance mechanism." clearly, that partnership was based on trust that the universities would discharge their oversight responsibilities dispas­ sionately and without conflicts, and that trust was tested during the late 34. see 2 ass'n of american medical colleges, supra note 27. 35. ezekiel j. emanual & daniel steiner, sounding board: institutional conflict of interest, 332 n. eng. j. men. 262, 262-67 {1995). 36. 1 ass'n of american medical colleges, supra note 27; 2 ass'n of american medical colleges, supra note 27. 37. 2 ass'n of american medical colleges, supra note 27, at 2-3. i have inserted the brackets to emphasize that the definition is applicable to all academic research. 18 indiana heal til law review [vol. 8:1 1990s when the issue of institutional fcois first surfaced as a matter of concern in human subjects research. but the credibility of universities as socially privileged institutions of public trust and the integrity of university research is certainly not limited to research involving human subjects. it is worth recalling here an inspiring articulation of the crucial role of universi­ ties in society that i ftrst cited in my aforementioned journal of the ameri­ can medical association ("jama") commentary a decade ago, the origin of which is unknown: all true universities, whether public or private, are public trusts designed to advance knowledge by safe­ guarding the free inquiry of impartial teachers and scholars. their independence is essential because the university provides knowledge not only to its stu­ dents, but also to the public agency in need of expert guidance and the general society in need of greater knowledge; and ... these latter clients have a stake in disinterested professional opinion, stated without fear or favor, which the institution is morally required to respect.38 institutional fcoi remains a critically important challenge, at the heart of the "federalacademic research partnership," to which neither the uni­ versity community, the federal government, nor the public has yet come to terms.39 38. david kom, commentary, c01iflicts of interest in biomedical research, 284 jama 2234, 2234 (2000). in my jama commentary, i attributed this language to the "declaration of principles" issued by the association of american university professors in 1915, when the challenges had to do with tenure, not fcois. such was the citation that ac­ companied this language when i first encountered it in a published article that i can no long­ er remember. i only recently learned from the aaup that the attribution is incorrect, so the source is now unknown. i would be proud to claim authorship because i wholeheartedly agree with the rhetoric. 39. in january 2011, the dhhs office of the inspector general ("oig") issued its first report entitled institutional conflicts of interest at nih grantees. the study was a survey of 250 awardee institutions, asking whether they had any policies and procedures addressing institutional financial interests and conflicts of interest only 156 institutions replied, of which seventy responded positively, and of these only fifty-nine had written policies and procedures ("p&ps"). twenty-one institutions' p&ps had written definitions oflnstitutional financial interests, and of these eighteen also had written definitions of an institutional fi­ nancial conflict of interest ("ifcoi"). the definitions were variable, with the most common elements being institutional equity in private and/or public entities, financial holdings of institutional officials overseeing research (including members of research oversight commit­ tees), institutional royalties flowing from intellectual property, and gifts to the institution from research sponsors. see off. of tile inspector gen., dep't of health and human serv., oei-03-09-00480, institutional conflicts of interest at nih grantees (2011 ), available at http://oig.hhs.gov/oei/reports/oei-03-09-00480;pdt: the most common man­ agement strategy, as recommended in the aamc report, was separation of the administra2011) financial conflicts of interest in academic medicine 19 v. financial conflicts of interest, where they went during this first decade of the 21st century, congress, the major me­ dia, and the general public have become much more aware and much less tolerant of fcois in individuals, organizations, and professions that assert or are generally presumed to have fiduciary responsibilities. with respect to universities, academic medical institutions, and the medical profession and its vendors, bitingly critical books have been published, such as: the truth about drug companies: how they deceive us and what to do about it,40 by marcia angell; on the take: how medicine's complicity with big business can endanger your health,41 by jerome kassirer; uni­ versity, inc: the corporate corruption of higher education,42 by jennifer washburn; and universities in the marketplace,43 by derek bok. the col­ lapse of the "high tech bubble" at the tum of the century, and the collapse of enron, worldcom, etc., wiped out jobs and pensions and exposed the cor­ ruption of the accounting profession, which had learned that cultivating large consulting practices with their clients was ever so much more lucra­ tive than auditing them. then, slightly more than half a decade later, the great recession, which nearly brought down the world's financial systems, was the price paid by the public for rampant self-dealing and betrayal of fiduciary obligations in the world of high-finance, bond ratings, and mort­ gage lending and securitization. in the middle of this decade, eliot spitzer, then the attorney general of new york, filed a criminal fraud complaint against the international pharmaceutical powerhouse, glaxosmithkline c'gsk"), and several of its smaller company partners for systematically suppressing the results of negative clinical trials designed to evaluate the safety and efficacy of anti­ depressant medications in children and teenagers, populations in which the therapeutics had never been tested but were being heavily marketed. 44 that the pharmaceutical industry did such things as part of their marketing strat­ egies was not really unexpected, but the filing of the criminal complaint most certainly captured the attention of the industry, the medical profession, tive oversight of research from financial management, and the most common "remedy" was disclosure. the report strongly recommended that nih regulate lfcois, and nih, in its response, demurred, writing "institutional conflict of interest is a highly complex issue .... therefore, we will take the oig's recommendation into consideration as we consider future actions on extramural financial conflict of interest." ld. at 24. 40. marcia angell, the truth about the drug companies: how they deceive us and what to do about it (2004). 41. jerome kassirer, on the take: how medicine's complicity with big business can endanger your health (2005). 42. jennifer washburn, university, inc: the corporate corruption of higher education, (2005). 43. derek bok, unnersities in the marketplace: the commercialization of higher education (2003). 44. see complaint, new york v. glaxosmithkline, no. 04-cv-5304 (n.y. sup. ct. june 2, 2004). 20 indiana health law review [vol. 8:1 and the public. the complaint was ultimately settled for hundreds of mil­ lions of dollars, and as part of the settlement the companies were forced to pledge going forward that they would post on their publicly accessible web­ sites all of the clinical trials they sponsored, without exception. by doing so, scholars would be able to identify trials that would never appear in the literature, and the fda, trials that, illegally, had not been reported in new drug registration or new drug indication packets submitted by the manufac­ turers for agency approval. this was the first time such a demand had been imposed on the industry, and in its aftermath, many of the industry's lead­ ing companies, as well as its dc-based lobbying organization, phrma, decided to do the same, beginning a long-overdue and most welcome pro­ cess of industry transparency that would only increase in subsequent years. spitzer did not limit his prosecutorial zeal to the pharmaceutical industry, but then turned his attention seriatim to the several sectors of the financial services industry, in most instances successfully winning large punitive fi­ nancial settlements of charges of betrayal of fiduciary responsibilities, as well as commitments to substantial changes in long-established industry behaviors and practices. spitzer was succeeded as attorney general by andrew cuomo, who turned his attention to financial self-dealing by universities in their student loan and overseas studies programs, respectively. with respect to the former, cuomo illuminated the widespread university practice of promoting to their students one or more favored lenders, from which the institution would receive guaranteed financial kickbacks. in the overseas studies programs, institutional officials were selecting contractors in part on ven­ dors' willingness to provide financial kickbacks directly to them. in both instances, cuomo filed class-action complaints naming many universities, and the resulting settlements forced changes in administrative behaviors and the cessation of kickbacks. neither of these well-publicized episodes brought favor to the universities or sincerity to their pledges always to put the interests of their students first and foremost. the events recited here, and perhaps especially the pioneering prose­ cutorial work of ag spitzer, greatly raised public awareness of the damages and suffering that can be caused by covert financial co is. let me offer two brief illustrative examples. the first is from an article in the washington post on january 6, 2008: "the financial planning association .... sued over whether brokers could call themselves investment advisors . . . . [a] federal apfeals court in dc said no. a stockbroker is a salesperson, not an advisor.';<4 the second is from the new york times on november 21,2009 and cites from the criminal complaint filed by the state of ohio against moody's, standard and poor's, and fitch, the "big-3" bond rating agencies: 45. jane bryant quinn, split of brokers and advisers forces customers to choose, wash. post, jan. 6, 2008, at fl. 2011] financial conflicts of interest in academic medicine 21 "we believe that the credit rating agencies, in exchange for fees, departed from their objective, neutral role as arbiters ... [and sold their integrity] ... to the highest bidder.',46 rating agencies are paid by the issuers of the secu­ rities they are hired to rate and do not receive their full fees unless the re­ quested rating is provided.47 such is the assurance system on which the financial markets and countless investors depend for independent, credible valuation of marketed securities! the failure of the bond rating companies is sadly reminiscent of the collapse of the accounting industry a decade ear­ lier. vi. enter the national institutes of health (nih) and the dhhs oig the year 2004-2005 can aptly be called nih's annus horribilis, a year of great embarrassment and punitive fcoi regulations. the nih is a feder­ al agency nested formally within the phs within the dhhs. as such, the agency might be expected to conform to the stringent fcoi regulations that apply to all federal employees. however, in the mid-1990s then director harold v armus won significant relaxation of these rules, primarily on the ground that it would facilitate his ability to recruit and retain top-level basic and, especially, clinical investigators from academia. university faculty salaries had begun to escalate sharply, especially in medicine and the bio­ medical sciences, and additionally, faculty generally enjoyed a "one-day a week" consulting privilege that enabled them to interact with the private sector and receive handsome fees. the federal government had in prior years partially relaxed compensation limits, especially for federal physi­ cians and physician scientists, but varmus argued persuasively that relaxing the federal fcoi regulations to permit freer consultative activities for full­ time nih scientists would significantly facilitate nih's efforts in recruit­ ment and retention of "stars." the modified regulation established an fcoi oversight process within the office of the nih director and imposed ap­ propriate boundaries on the relaxed consulting privilege. the key feature of the oversight system was disclosure and prior approval. in december 2003, the los angeles times published the first in a se­ ries of articles by investigative reporter, david willman,48 naming senior nih scientists and accusing them of major violations of the agency's re­ laxed fcoi rules. some of the behaviors described were indeed distressing and would have been equally so for academics, and the articles implied that such violations might be widespread among the nih's senior physi46. david segal, ohio sues rating firms for losses in funds, n.y. tlmes, nov. 21, 2009, atbl. 47. see id. 48. david willman, stealth merger: drug companies and government medical re­ search, los angeles times, dec. 7, 2003, at al. 22 indiana health law review [vol. 8:1 ciao-scientist corps.49 the nih began an intense review of its fcoi rec­ ords, and the congressional oversight committees scheduled hearings; al­ legations were freely being thrown about, congress was furious, the dhhs was embarrassed and angry, and, in truth, no one at that instant knew how widespread these violations might be; the nih's oversight system seemed to have broken down. to try to limit the damage and regain the initiative, the us office of government ethics either decided or was ordered to tight­ en the nih fcoi rules significantly. the revised and truly draconian regu­ lations50 were imposed upon the nih and took effect immediately: they essentially forbade nih scientists and staff from any consulting interactions with or financial holdings in organizations with which the agency interacted in any way ("substantially affected organizations ("saos")"). it was not even clear at the time whether nih scientists could give lectures at universi­ ties or academic medical institutions that received nih grants (saos), or serve as officers in their professional societies or on the editorial boards of their professional journals. in the end, the total numbers of wrongdoers identified within nih's ranks proved to but a relative handful, and about a year later, the draconian regulation was partially relaxed, although compen­ sated consulting relationships between saos and the nih leadership, offi­ cials in the agency's extramural programs, and nih scientists who conduct research on human subjects, the primary recruitment and retention targets of v armus' relaxation, remain largely prohibited to this time. when the nih furor was at its height, key congressional leaders wrote to then nih director elias zerhouni to ask, if the new fcoi regulation was good for the intramural nih scientists, why would it not be good as well for all the extramural scientists whose research programs and facilities con­ sumed more than eighty percent of the nih's annual appropriation in the form of sundry varieties of research project grants? publication of this inquiry sent tremors through the research universities and academic bio­ medicine. at about that time, two events occurred that are important to this narrative: 1. the dhhs oig deployed personnel to the nih campus to keep a close eye not only on nih's internal fcoi management but also on the agency's discharge of its oversight responsibilities for the extramural community under the 1995 fcoi regulation. the oig contingent settled into the nih campus, comfortably it would seem, since they remain there to this time. 2. in september 2005, a small group ofleaders from the aau and 49. seeid. 50. see supplemental standards of ethical conduct and financial disclosure re­ quirements for employees oftbe department of health and human services, 70 fed. reg. 5543 (interim final rule with request for comment), available at http://www.gpo.gov/fdsys/ pkg/fr-2005-02-03/pdf705-2029.pdf. 2011] financial conflicts of interest in academic medicine 23 aamc constituencies, which included me, convened in dc to consider an appropriate response from the university and aca­ demic medical communities to the troubling events occurring at the nih, the public anger provoked, and the interest of key congresspersons to extend the nih•s punitive fcoi rule to the extramural community. the group agreed that research univer­ sities and academic medical centers exist in a "concatenated chain of trust and interdependence, •• such that regulatory lapses by any one member can bring retribution to the entire commu­ nity in the form of new law or regulation, and they identified as one key issue of concern a lack of consistency in fcoi policies and practices across our member institutions. a second key concern was, and remains, the problem of "clashing mixed messages;• or what i have dubbed the "conflict of public expec­ tations;• that is, that academia must be ever more vigorous in promoting technology transfer and partnering with the private sector while remaining pristine and untarnished by any appear­ ance of fcoi. because inconsistency in fcoi policies and practices posed a danger to all, the group urged the aamc and aau to combine their efforts and establish a new initiative aimed at promoting greater consistency in fcoi practices across the academic community. i shall return to this initiative shortly. vii. the academic communtiy shoots itself in the foot perhaps of its own volition, perhaps because the oig was breathing down its neck, the nlli decided to conduct targeted site reviews ("tsrs,,) at eighteen public and private awardee institutions to examine how well they were complying with their obligations under the fcoi regulation. the final report, which the nlli decided to post quietly on its website51 without any publicity, lavishly praised the seriousness and diligence the targeted institutions were demonstrating in trying to comply with the fcoi rule. 52 however, they did report three areas of concern: 1. the institutions were using too narrow a definition of "investiga­ tor•• with respect to who on a research team must disclose related financial interests. 53 [the rule addresses this point clearly.] 51. see notice, national institutes of health, observations from nih's targeted site reviews on financial conflict of interest (feb. 16, 2007), available at http://grants.nih.gov/ grants/guide/notice-files/not-od-07-048.html. 52. see national institutes of health, targeted site reviews on financial conflict of interest observations (2007), available at http://grants.nih.gov/grants/policy /coi/tsr _observations_ 2-14-2007 .doc. 53. ld. at2. 24 indiana health law review [vol. 8:1 2. the institutions were not diligently exercising their obligation to report to nlli every instance in which they had detected and dealt with an fcoi in a federal grant recipient. 54 some institu­ tions had simply "forgotten." for months at a time. [i earlier called attention to the simplicity of this requirement as evidence of the light-handedness of the rule.] 3. the institutions were not satisfactorily discharging their obliga­ tion to monitor subrecipients participating in the funded re­ search. 55 [this issue is admittedly challenging because the institutions have no formal oversight authority of their research project subrecipients.] in spite of the nlli's effort to downplay its report, the posting was noted by the oig, which launched a formal investigation of nlli's over­ sight of the 1995 rule. 56 the oig report was sharply critical of the nlli's stewardship, and much of its report focused on that. for example, it found that the agency had no idea how many fcoi reports bad been submitted by awardee institutions in past years, partly because each nlli institute was collecting reports from its own awardees on paper, and those reports could not be found, and partly because nlli's requirement that all reports to the institutes be shared with the office ofthe director (''od") had been widely ignored for more than a decade.57 in any event, the od had no central file;58 worse yet, it had no idea how many fcoi reports, required under the rule, the nlli had received. 59 the oig issued three recommendations, two of them directed at the nlli, viz., that nlli greatly increase its efforts to as­ sure intra-agency compliance, and that the od rapid!~ establish a central electronic record system for awardees' fcoi reports. the third recom­ mendation, unexpectedly, turned away from the nlli and toward the award­ ee community and asserted that the institutions should be required to disclose to the nlli all potential fcois they detect, and that the nlli should examine the details of the institutions' reviews, decisions, and mitigation processes.61 this last recommendation stunned the academic community because it called for fundamental change in the interpretation and implementation of the 1995 rule, and much more intrusive nlli participation in what had been exclusively the prerogative of the institutions: to evaluate their faculty in54. id 55. id 56. see off. of the inspector gen., dep't of health and human serv., oei-0306-00460, nat'l inst. of health: conflicts of interest in ex'iramural research (2008), http://oig.hhs.gov/oei/reports/oei-03-06-00460.pdf. 57. id at 5. 58. id at9. 59. /d. 60. id. at 16. 61. id. at 17. 2011] financial conflicts of interest in academic medicine 25 vestigators' disclosures and make what must be ultimately judgment calls about the existence of a fcoi and its magnitude, severity, relatedness to the research project, and ultimately, its disposition. although nih's response made clear thatit had neither the interest nor the capability to manage such a workload, it nonetheless soon after (february 2008) requested for the frrst time from nineteen awardee institutions detailed information about fcois, about which the institutions had dutifully notified the agency. the oig had showed its hand, and it was not to be for the last time. vlll. new actors enter the fcoi mix the nih's tsrs attracted a new source of attention, from senators charles grassley, the then ranking member of the senate finance commit­ tee, and herb kohl, the then chairman of the senate ageing committee. both committees have keen interest in the medicare program and its costs, and the senators were concerned that fcois could bias clinical research in favor of new and expensive therapeutics produced by the sponsoring com­ panies. also troubling were the promotional talks extolling new drugs and devices, delivered to physician audiences by influential academic specialists who neglected to disclose that they were being compensated handsomely for these talks by the products' manufacturers. both senators turned their attention to fcois in academic medicine. grassley began by requesting information from nih about the responses to the tsrs nih had received from the visited institutions. at about the same time, congressmen john dingle and bart stupak, members of the oversight and investigations sub­ commi~ of the house energy and commerce committee, sent a letter to the director of the national cancer institute ("nci,.) seeking information about a large nci-sponsored clinical trial designed to evaluate the effec­ tiveness of computed tomography ("ct'') chest scans in detecting small and putatively operable neoplasms in the lungs. there was considerable debate within the medical profession, and concern in medicare, not only about the medical effectiveness but also the cost-effectiveness of such a very expensive diagnostic screening technology. but the trial became the center of even more controversy when it was learned that the lead co­ principal investigator ("pf'), a professor of radiology at the cornell-weil medical school, and at least one other key participant, had nearly a dozen patents filed on key aspects of the screening technology being used, the value of which would soar if the technology became accepted for broad population screening. unfortunately, the co-pi had failed to notify the nci about her patents when she was being chosen to lead the study, and further inquiry revealed that she had often "forgotten" to mention the patents in manuscripts she submitted to journals for publication. a new actor, then new jersey attorney general christopher christie, also concerned about the medical profession's increasingly cozy financial relationships with its vendor industries and their effects on the costs of 26 indiana health law review [vol. 8:1 health care, subpoenaed records of payments to orthopedists from the five largest manufacturers of orthopedic devices, declaring these to be illegal kickbacks. the manufacturers fairly quickly agreed to settle a civil com­ plaint for multi-hundreds of million dollars (aggregate) in penalties and fur­ ther agreed to post all such payments henceforth on their company websites where they would be visible to the public. this was the frrst time that ven­ dors of health products had been forced to reveal to the public their covert payments to physician or surgeon customers. the settlement attracted sen­ ator grassley, who joined with ag christie to turn the spotlight onto the orthopedists receiving these payments, most of whom, not surprisingly, were recognized leaders in academic medicine. among other queries, the investigators asked whether the surgeons had disclosed their payments to their patients and to their academic institutions. grassley and kohl then greatly intensified the inquiry by demanding from pharmaceutical and med­ ical device manufacturers a full accounting of their payments to a named group of academic physician leaders during the prior seven years. the phy­ sicians were culled from psychiatry, orthopedics and cardiology and were known to the vendor companies as "key opinion leaders," ("kols"), be­ cause of their professional eminence and influence in their specialties. the senators then requested from the physicians' academic institutions records of the vendor payments the doctors had disclosed to them. for a variety of reasons that included differences in accounting periods, or inclusion of ex­ pense reimbursements in vendors' tallies of payments, as well as failure of the physicians to report these payments fully and accurately, or at all, there inevitably were discrepancies, some modest, more of them large, some very large. finally, senator grassley sent formal letters to the target physi­ cian(s), his or her hospital president, and often his or her university presi­ dent, charging failures of the named physicians and surgeons, fully and accurately to report their vendor payments from named companies, and failure of the institutional systems for capturing these payments to detect non-compliance. the senator rolled out his charges seriatim, in each in­ stance first reading his indictment into the congressional record before releasing the story to a favored new york times or wall street journal re­ porter. grassley's revelations received blaring front-page publicity and roiled the involved institutions as well as the accused physicians, and disci­ plinary proceedings ensued for violations of institutional disclosure poli­ cies. whatever other motivations senator grassley may have had, he ac­ complished his major objective of demonstrating the frailty and failings of institutions' :tt:oi policies and processes based entirely on faculty mem­ bers' disclosures of financial interests that they alone determine should be disclosed, and which lack capability to verify completeness and accuracy. by doing so, the senator added fuel to the fire that the oig had already ig2011] financial conflici's of interest in academic medicine 27 nited within the nlli. but for academic medicine a partial remedy looms in the recently enacted health care reform act,62 which contains within its voluminous pages the entire grassley-kohl sunshine act,63 which man­ dates annual reporting by vendors of all of their payments above a de mini­ mis to physicians and health care institutions.64 these payments are to be organized and displayed in a publicly accessible register, one may only hope in a standardized and useful manner, on a website to be created by the dhhs.65 the system. is to become operative in 2013.66 in the meantime, many of the major health care vendors have already established company sites on which they are listing quarterly or semi-annually all their payments to physicians. some of these sites have been created voluntarily; at least eighteen result from costly settlements of criminal complaints of off-label promotion of therapeutics, which have typically been accompanied by cor­ porate integrity agreements; the 2 largest settlements involved eli lilly in 2008 for $1.4b and pfizer in 2009 for $2.3b.67 although these actions certainly add welcome and needed transparen­ cy to what had been an entirely covert system for influencing physician's therapeutic decisions, it remains to be determined how effective these pub­ lic disclosures will be in altering public perceptions or physician behaviors. two recent examples illustrate the challenge. the first is from the trade publication, the pink sheet, october 19, 2009. lilly posted its first quarter payments, and the highest paid was a psychiatrist, who reported that "he was initially concerned that payment databases could be misleading or used to attack a physician's credibility. [he] changed his mind, however, once he told his patients about his work with pharma companies and they re­ sponded positively."68 the second, from the boston globe, january 23, 2010, describes a harvard medical school faculty physician who resigned his faculty and hospital appointments, the latter at the brigham and wom­ en's hospital, to continue his heavy schedule of promotional speeches, for which was being paid handsomely as a contracted participant in a gsk speakers bureau. the us director of media relations for glaxo was "not sure whether [the physician] will be as much in demand as a speaker with­ out the prestigious brigham and harvard titles.',69 62. patient protection and affordable care act, pub. l. no. 111-148, 124 stat 119 (2010). 63. physician payments sunshine act of2009, s. 301, 111th cong. (2009). 64. s. 301 §2(a)(1). 65. s. 301 §2(c)(1)(c). 66. patient protection and affordable care act, pub. l. no. 111-148, §6002, 124 stat. 119,689 (2010). 67. aaron kesselheim, et al, whistle-blowers' experiences in fraud litigation against pharmaceutical companies, 362 neweng.j.med. 1832, 1833 (2010). 68. lilly outside "faculty" is headed by 22 physicians receiving $50,000 or more, the pink sheet, oct 19, 2009, available at http://www.biopharmatoday.com/2009/l 0/lilly­ outside-faculty-is-headed-by-22-physicians-receiving-50000-or-more.html. 69. liz kowalczyk, doctor quits brigham to speak for pay; partners has strict rules 28 indiana health law review [vol. 8:1 ix. again, the academic community responds a few months following the september 2005 gathering of aau and aamc leaders, the associations formed a joint committee, chaired by mark wrighton, chancellor of wustl, and comprised of four sitting university presidents or chancellors and fifteen leaders from the academic medical community. as with the prior aamc task force, this initiative came un­ der the purview of my aamc team. the committee, whose report was published in february 2008/0 was charged to begin with the aamc's prior reports on individual and institutional :tt:ois, define the key issues that needed to be addressed, refine and clarify the prior recommendations, and provide practical guidance to their communities. the committee's report was entitled protecting patients, preserving integrity, advancing health: accelerating the implementation of co/ policies in human subjects re­ search. the committee strongly reaffirmed the 200 l and 2002 recommen­ dations with a few modest refinements, stressed the necessity for more consistent policies and practices across academic institutions, and, cogni­ zant of what was happening at the nlli, warned that time was of the essence in fully implementing effective and comprehensive col policies.71 the urgency of this call to action was, in my view, unfortunately somewhat blunted by the committee's need to confine its work to human subjects research. but as before, the aau had remained adamant in linking its agreement to participate on the committee with retention of the limiting condition. the committee's report was entirely heuristic and designed to offer practical guidance. the three chapters addressed, respectively, individual :tt:oi, institutional :tt:oi, and implementation of :tt:oi policies, and the five appendices: model institutional :tt:oi policy; an analysis template with ten exemplary case studies; definition of financial interests in research; points to consider; and the committee roster.72 this report was envi­ sioned to be a "how to do it manual," and so it was. for better or worse, it broke little conceptual new ground. x. fcois in medical education in january 2006, a paper published in jama13 by twelve leaders of ac­ ademic medicine, including the then president of the aamc, berated the on drug-firm honoraria, the boston globe, jan. 23, 2010, at 1. 70. aamc-aau advisory commiitee on financial conflicts of interest in human subjects research, protecting patients, preservin(j integrity, advancing health: accelerating the implementation of col policies in human subjects research (2008), available at www.aau.edu/research!rpt _aau-aamc _ coi_208.pdf. 71. see id. 72. id 73. troyen a. brennan et al., health industry practices that create conflicts of inter­ est: a policy proposal for academic medical centers, 295 jama 429 (2006). 2011] financial conflicts of interest in academic medicine 29 "entitlement" culture that had become so embedded in the medical profes­ sion, under which physicians had become habituated to receiving billions of dollars a year in gifts, meals, paid travels to exotic destinations, etc. from the pharmaceutical and medical device industries, and to a lesser extent, the biotechnology industry. these payments come entirely from the compa­ nies' marketing budgets under the umbrella of "medical education" and have been shown repeatedly in proprietary industry studies to be an espe­ cially effective mechanism for winning physicians' uptake of new and typi­ cally very expensive company products, independent of credible (or any) data demonstrating that those products were as effective or better than com­ parable therapeutics already on the market, many of which have been thor­ oughly studied over the years and were especially well understand in diverse practice settings, and many of which have gone off-patent and be­ come generic. the authors declared these payments create fundamental ft:ois with medical professionalism and urged that they be eliminated from the profession, beginning in the academic medical centers, where future generations of physicians are nurtured in the science, art, and professional standards and ethics of medicine. 74 these unseemly habits and practices increase public suspicion of physicians, their institutions, and their profes­ sional organizations, and they undermine confidence in the independence of institutional and individual decision making; the altruism of the physician and the profession; personal and institutional integrity; the trustworthiness of academic medicine across its missions; and the ability and capacity of academic medicine to self-regulate. although a few of the nation's leading academic medical centers had already begun in 2005-06 to implement new stringent institutional policies to eliminate or sharply circumscribe these offending practices, the aamc decided it was appropriate to form a task force on industry funding of medical education75 that would include senior officials from the industry as well as from academic medicine with the aim of stimulating a productive dialogue and the hope of reaching some consensus. this initiative once again fell under the direction of my team. the task force was chaired by roy v age los, the retired and respected long-time chairman of merck, and vice-chaired by william danforth, who had chaired the aamc's first task force on ft:ois. the roster contained in addition to leaders and faculty from academic medical centers, medical students and residents, bioethicists, members of the public, and four sitting industry ceos, from pfizer, lilly, amgen and medtronic, respectively. the task force was charged to forge consensus principles to guide medical schools and teaching hospitals in de74. id at431. 75. see association of american medical colleges, industry funding of medical education: report of an aamc task. force (2008), available at https://services.aamc.org/publicationslsbowfile.cfin?file=versionll4.pdf&prd _id=232&prv _ id=281&pdf_id=114. 30 indiana health law review [vol. 8:1 veloping policies and procedures for managing ·various forms of industry support of medical education. the aamc made clear at the outset its con­ cerns with such industry funding, which included conflict of interest, com­ promise of objectivity and integrity of professional decision-making, blurring of marketing and scientific evidence, distortions in prescribing and in formulating practice guidelines, adverse effects on the ''hidden curricu­ lum" for students and trainees, and the growing body of scientific evi­ dence about influence and reciprocity, and the inadequacy of disclosure as a safeguard.76 i boldfaced the last because it was the stimulus for me to join with colleagues in organizing a scientific symposium on the topic, which took place a few months after the task force was launched, and to which i return below. over the course of about fourteen months, the task force agreed on the following important, albeit somewhat aspirational, recommendations: 1. academic medical centers should adopt policies consistent with the task force report to support a learning environment that nurtures professionalism. 77 . 2. to the extent that certain interactions with industry are prohib­ ited within academic medical centers, they should also be pro­ hibited off-site. 78 3. industry should not invite academic medical center personnel to participate in practices off-site that the medical center prohibits on-site.79 4. academic medical centers should expect their off-site teaching and training partners to adhere to the standards of the medical center regarding interactions with industry. 80 5. academic medical centers should raise awareness among stu­ dents and faculty of the challenffs to professionalism presented by certain industry interactions. 1 6. academic medical centers should ensure o~jk>rtunities for stu­ dents to build their critical evaluation skills. 7. academic medical centers should increase students' under­ standing of the processes of drug discovery, clinical testing, as-­ sessment of drug and device safety, the difference between efficacy and effectiveness, and fda regulations. 83 the task force also agreed, after much deliberation and debate, that 76. id at 1, 3-8. 77. id. at 26. 78. id. at 17. 79. ld. at9. 80. ld. at 10. 81. id.atll. 82. ld. 83. id at26. 2011] financial conflicts of interest in academic medicine 31 academic medical institutions should ban all gifts84; restrict site access by pharmaceutical and device representatives (aka "salespersons");85 prohibit direct industry funding of continuing medical education;86 require indus­ trysponsored educational grants for students and trainees to be gifts to the medical center and not to individuals;87 ban travel funds from industry for merely attending meetings;88 and ban ghostwriting and guest authorship.89 the task force struggled but could not reach consensus on: banning phar­ maceutical samples; faculty and student participation in industry-sponsored, non-accredited "educational" programs; and, most contentious of all, facul­ ty participation in industry "speakers bureaus." of the several reports de­ veloped at the aamc under the direction of my team, i am least able to estimate the impact of this report on the academic medical community, alt­ hough i am confident it has been helpful to them in dealing with these diffi­ cult issues in their own institutions and communities. it is very hard to break engrained habits and give up engrained expectations! i know for cer­ tain, however, that the participation of the industry ceos and their top dep­ uties in this often contentious undertaking had a major impact on them: it opened their eyes to the firm resolve of the leadership of academic medicine to eliminate "business as usual" and begin what will be a long and difficult process of eradicating this degrading "culture of entitlement" from the med­ ical profession. most of this manuscript has focused on fcois in academic biomedical research, and the reader may be puzzled by my introduction of fcois in medical education at this point. in part, it was because the narrative has been chronological, and this topic hit the aamc's radar screen and the pro­ fession at this time. but more importantly, the topic does relate directly to my predominant research theme: the "culture of entitlement" has aroused many critics who find the practices just discussed repellent, and in their out­ rage some of them have taken to demonizing the pharmaceutical industry. in my aforementioned commentary in the boston review i wrote: some commentators address these issues by demoniz­ ing pharmaceutical and related vendor industries and advocating for marked reduction or even total elimi­ nation of interactions between them and academic medicine. such uncompromising rhetoric has its own adverse consequences . . . . i advocate distinction of those industry relationships that are largely gratuitous, 84. id. at 14. 85. /d. at 17. 86. /d. at 19. 87. /d. at2l. 88. /d. at 22. 89. id. 32 indiana health law review distracting, self-indulgent, and corrupting, and should be eliminated, from those that have value and serve important public functions.90 [vol. 8:1 primary among the latter are legitimate research relationships, conducted ethically and transparently, between academic medicine and industry that are essential to identify and validate new drug targets and facilitate the re­ duction of biomedical scientific inventions into tangible public benefits such as new diagnostics, therapeutics, and medical devices. by eliminating the "culture of entitlement" that has become so embedded in medical educa­ tion and practice, those relationships between academic medicine and in­ dustry in research that have integrity and are essential can be strengthened and flourish and they can be evaluated in their own right rather than being smeared and condemned vicariously, as they too often now are. xi. the scientific basis of influence and reciprocity: a symposium on june 12, 2007, colleagues from the baylor college of medicine and i organized a symposium to present the latest scientific insights into influence and reciprocity, and we published a monograph summarizing what we had learned.91 we chose this topic because exciting new insights are emerging from the neurosciences, behavioral economics and psycholo­ gy that are directly relevant to cois. we were fortunate to assemble four of the leading investigators in the field: read montague, phd, then professor of neuroscience and director of the human neuroimaging laboratory, baylor college of medicine; dan ariely, phd, then sloan professor of be­ havioral economics, mit sloan school of management; george loewen­ stein, phd, herbert a. simon professor of economics and psychology, carnegie mellon university; and max bazerman, phd, d.sc. economics (hon), jesse lsidor straus professor of business administration, harvard business school.92 · montague described the use of fmri technology in classical behav­ ioral experiments to demonstrate the anatomical correlates of the effects of favors and other forms of influence on persons' choices. 93 there are specif­ ic neural pathways in areas of the brain that lie beneath awareness (neuro­ scientists avoid the freudian connotations of ''the unconscious") that consistently respond to favors or other acts of kindness, or even the antici90. kom, supra note 28. 91. see symposium, supra note 4. 92. space permits only a snapshot of the insights presented, but for those interested, the monograph is freely available online. see generally symposium, supra note 4. 93. id at 9-12. 2011] financial conflicts of interest in academic medicine 33 pation of such, and that influence our choices and decisions.94 there is no reason to doubt that these pathways are functional in all human beings, and there is reason to suggest that they may be of ancient origin and evolved under heavy positive selection. these studies, consistent with prior evi­ dence from psychology, sociology, and behavioral economics, are illumi­ nating the neurological substrates of cognitive behaviors that occur without awareness. some have dubbed these processes "deliberation beneath awareness" or "deliberation without intention.'.95 ariely summarized a large body of empirical evidence indicating that persons can tolerate a limited amount of dishonest behavior without impair­ ing their self-image or self-worth.96 that is, persons' internalized standards of acceptable behaviors seem to permit some bounded ''wiggle room" with­ in which limited amounts of dishonest behaviors do not threaten persons' image of self.97 importantly, such "limited amounts" are typically less than the maximum that is possible. 98 in other words, persons seemingly will cheat if given the opportunity, but just a little. "mindfulness" appears to reduce significantly the amount of dishonest behavior under identical exper­ imental conditions. 99 in one experiment, measurable "mindfulness" was accomplished simply by flashing a copy of the ten commandments before the experimental subjects before the "cheating experiment" began.100 loewenstein taught that traditional economics assumes that profes­ sionalism and cois are asymmetric motives in influencing behavior, and that persons who confront cois are equipped to recognize and deal with them rationally.101 behavioral economics posits a more complex model of decision-making, "one that includes unconscious motives and other factors outside the control of a purely rational process" and biases are viewed as unconscious (or beneath awareness ).102 persons reveal a tendency to give themselves "moral wiggle room" by selectively seeking out or ignoring in­ formation so as to permit "unethical behavior with an easy conscience.''103 disclosure may perversely "give the adviser a 'moral license' for strategic exaggeration in the adviser's best interest.''104 bazerman reiterated from his own work the concepts of "bounded awareness" in decision making and ''bounded ethicality,'' by which he 94. see id. 95. see generally ap dijksteruis, et al., on making the right choice: the deliberation-without-attention effect, 311 sci. 1005 (2006). 96. see symposium, supra note 4, at 13. 97. see id at 13-17. 98. seeid 99. see id 100. see id. at 16. 101. see id. at 19. 102. seeid. 103. seeid. at20. i 04. see id at 22. 34 indiana health law review [vol. 8:1 means the systematic and predictable ways in which persons act unethically beyond their own awareness.105 bazerman referenced a quotation from up­ ton sinclair: "it is difficult to get a man to understand something when his salary depends on his not understanding it106." bazerman then drew a chilling parallel between the professions of medicine and accounting, re­ counting the massive corporate accounting scandals at the tum of the 21st century, and the failure of the accounting profession's fiduciary responsi­ bility to the public.107 he argued that because of the cozy relations between the medical profession and its vendors, the profession might be on a similar cusp facing loss of public confidence and perceived betrayal of fiduciary 'b'l' 108 responst 1 tty. · . comment: the pharmaceutical and device industries are well aware of the potency of their gifts, paid travels, favors and blandishments to influ­ ence physicians' choices and judgments "beneath their awareness," and they have comprehensive proprietary databases that demonstrate the effec­ tiveness of their promotional strategies. the industry especially welcomes the vehement denials of susceptibility by their targeted physician "key opinion leaders" and their indignation at the very thought they could be susceptible to the vendors' blandishments. as one former pharmaceutical ceo snorted when invited to the symposium, "we. don't need science! we know they [industry's promotional tactics] work! why the hell do you think we spend so many billions of dollars a year supporting them?"109 xll. financial confucts of interest: where they are, where we are the oig, still ensconced on the nih campus, followed up its earlier examination and condemnation of nih's stewardship of the 1995 rule by turning its attention to the awardee community and requesting from forty­ one awardee institutions "detailed information" about instances of fcoi they had reported to the nih and .after reviewing these submissions, the oig's second report on the topic, issued in november 2009, focused entire­ ly on how the institutions were complying with the rule.110 the report was scathing, its tone often skeptical or incredulous. key exemplary findings were: ninety percent of the sample rely "solely on the researchers' discre105. see id at 25. 106. id 107. seeid at26. 108. see id. at 26-27. 109. private personal communication, spring, 2007. 110. see off. of the inspector gen., dep't of health and human serv., oei-0307-00700, how grantees manage confucts of interest in research funded by the national institijtes of health (2009), available at http:/loig.hhs.gov/oei/reports/oei-0307 -00700.pdf. 2011] financial conflicts of interest in academic medicine 35 tion to determine which of their significant financial interests" should be reported to their institutions; 111 almost half the sample does not re~uire that their faculty members • reports contain specific financial values; 11 there is no routine verification of the information provided; 113 there is lack of doc­ umentation of management strategies used for identified fcois; 114 the uni­ versities are not required to report their own financial interests with outside research-related entities.115 among the key recommendations were that: universities should re­ port to nih the details of the teo is that they detect; 116 "collect information on all significant financial interests held by" their faculty researchers;117 develop methods to verify faculty members' reported financial interests;118 ensure proper documentation and enforcement of the rule.119 key rec­ ommendations to the nlli were: nih should increase its oversight and should develop new regulations that address institutional jcois .120 as their earlier report had clearly signaled, the oig seemed convinced that neither the awardee institutions nor the nih had taken the 1995 fcoi rule seriously enough or exercised their respectively assigned duties ac­ ceptably. the nih's failures were in accurate record keeping, comfortably remediable within the confines of the rule; in sufficiently vigorous over­ sight, somewhat vague, and troubling for that; and in its lack of oversight of awardee institutions' own related financial interests, that is, their institu­ tional fcois ("ifcois"). because ifcois were not recognized at the time, they are not mentioned in the 1995 rule, and to address them would require a significant revision or rewriting, as the oig recommended.121 although, because that rule was so wondrously light-handed, the academic communi­ ty will always become anxious at any mention of its possible revision, i would nonetheless argue that nih could respond reasonably to the oig's recommendations without fundamental upheaval of the current fcoi re­ gime. but the failings of the academic community identified by the oig touch on fundamental matters at the heart of the university's relationship with its faculty, with the nih, and with society, all three ofwhich are built on trust. thus, it was natural for the universities to expect their faculty members to be dutiful and accurate in reporting their sfis that they deter111. /d. at 13. 112. id at 13-14. 113. id at 14-15. 114. id. at 16-17. 115. id. at 18. 116. id. at 19-20. 117. id at20. 118. id at 21. 119. id. 120. id at21-22. 121. see off. of the inspector gen, supra note 56, at 18. 36 indiana health law review [vol. 8:1 mined could be perceived to be related to their federally sponsored research proposals, and for many institutions to decide they needed to know only where those sfis fell within broad tranches, but not specific amounts. and under the terms of the federal-academic research partnership, it was natu­ ral for the nih to trust the universities to determine whether reported sfis rose to fcois, and if so, to dispose of them appropriately and notify the agency nlli saw no need to probe further into the details. after all, part­ ners trust each other! as for the universities' relation to society, they have long been ex­ pected, among other functions, to serve as independent, objective, and trustworthy sources of expert information and guidance "to the public agen­ cy in need of expert guidance and the general society in need of greater knowledge."122 but in the past half-century, and increasingly in recent dec­ ades, universities have come to be expected to serve as engines of socio­ economic development in their communities and regions, sparking the growth of new industries built on new knowledge and technologies emanat­ ing from faculty research. this diffusion of new knowledge and "know­ how" occurs in multiple ways, as has been underscored in the newly re­ leased report from the national academies of sciences123 through migra­ tion into the private sector of graduate students and postdoctoral fellows, from faculty publications and consulting, from university-industry research partnerships, and frpm patenting and licensing faculty inventions. although the last is the smallest share of these mechanisms, it is the most easily quan­ tifiable and thereby, the most visible, and from the perspective of :teo is, the most problematic. the bayh-dole act legally established the university's first right to ownership of all faculty intellectual property ("ip") arising from federally supported research and obligated the institution to promote the transfer of that ip into the private sector for development. 124 in the past three decades, university engagement in technology transfer has soared, as measured by numbers of new patents, licenses, and start-up companies, and amounts of royalty revenues. 125 less publicly visible is the amount of equi­ ty that universities and their faculty-inventors have amassed, especially in start-up companies and other early-stage venture capital deals. thus, not only faculty researchers but also their institutions may now have substantial financial interests in areas in which the faculty may have legitimate ongoing research interests. for the faculty, the 1995 :tcoi rule 122. kom, supra note 38, at 2235. 123. see comm. on mgmt. of univ. intellectual prop., national acaoemy of sciences (nas)., managing universi1y intellecrual property in tim public interest (national academies press, 2010). 124. see patent and trademark act amendments of 1980, pub. l. no. 96-517, 94 stat. 3015. 125. see press release, association of university technology managers, u.s. licens­ ing activity survey (2010) (on file with author). 2011] financial conflicts of interest in academic medicine 37 defines "significant," albeit arbitrarily and without intrinsic validity;126 but what would constitute a "significant" financial interest for the university, and if there were such, what evidence would one seek to determine that the interest rises to ifcoi? or would that determination, as with individual fcoi, rest entirely on perception? but by whom or what official body? and, if one could credibly and reproducibly reach the determination of ifcoi, what remedies would be appropriate and realistic? by what man­ agement strategies could the existence of such financial holdings be made to comport with the role of universities as "independent arbiters of knowledge?"127 it is worth noting that more than three decades ago, in 1979, harvard university president derek bok famously turned down an offer of equity shares from three faculty founders of a new start-up biotech­ nology company, assertin~ in essence that a university should not go into business with its faculty. 1 perhaps bok foresaw the wrenching difficulties that lay ahead on such a path and concluded they would not be manageable and must therefore be avoided. his statement was truly a "shot heard 'round the academic research community," and harvard maintained this marvelously principled stance until may 1995, when its governing body determined that acceptance of such equity was acceptable. president bok devoted most of his 1979-1980 president's report to the members of the board of overseers to the issue of academic engagement with industry. in that address, accessible in the harvard university archives, he stated: "[t]he causes for concern .... flow from an uneasy sense that programs to exploit technological development are likely to confuse the university's central commitment to the pursuit of knowledge and learning by introduc­ ing into the very heart of the academic enterprise a new and powerful mo­ tive the search for commercial utility and fmancial gain."129 the academic community has come to no consensus on these knotty issues that arise from the "conflict of public expectations" and will only grow more intense as the magnitude of federal investments in science, and especially in biomedical science, continues to increase, and the public's impatience and thirst for tangible benefits diagnostics, treatments, cures, and solutions to a whole array of pressing social problemscontinue to rise. 126. see 45 c.f.r. § 94.3 (2009). 127. statement made by u.s. rep albert gore during a small meeting in 1981-82 at­ tended by the vice president for federal relations at the aau, who communicated it to dr. david kom shortly thereafter. 128. see generally derek bok, report of the president of harvard college and reports of departments: 1979-1980, 23-31 (1981), available at http://pds.lib.barvard.edu /pds/view/2582287?n= 19039&s=6&printthumbnails=no. 129. derek bok, report of me president of harvard college and reports of departments: 1979-1980, 6-7 (1981), available at http://pds.lib.harvard.edu/pds/view/ 25 82287?n= 19039&s=6&printthurnbnails=no. 38 indiana health law review [vol. 8:1 xlll. nlli issues an advanced notice of proposed rule making (anprm) folwwed by an nprm in spring 2009, nhi responded to the second oig report and con­ gressional prodding by issuing an anprm, 130 soliciting the views of the research community on changes to the 1995 rule based largely on the rec­ ommendations in the oig report, and in spring 2010, the agency issued a nprm.131 each of the notices received outpourings of comments from an anxious academic community, facing up to the reality that the 1995 rule was going to be changed, but perhaps not yet fully grasping that the chang­ es were being brought about largely by their own failures to be dutiful in discharging the relatively gentle obligations the rule had imposed upon them. at the time of this writing the nhi had not yet issued its final rule. the nprm was gentler than the oig's recommendations might have pre­ dicted, but it did nonetheless propose some important changes. among the­ se are: reducing by half the levels of financial interests in publicly trading companies that would be deemed significant, 132 and making more clear that any equity holdings in a privately traded company would be so deemed;133 requiring faculty researchers to disclose all of their sfis that might relate to their academic responsibilities, 134 and transferring entirely to the universi­ ties the responsibility for determininf which, if any of these, create fcois with federally sponsored research; 13 requiring the institutions to report to nlli details about these fcois and their disposition of them, including any management plans imposed;136 requiring more stringent oversight of the fcois of award sub-recipients;137 requiring training in fcoi for all re­ searchers prior to their initiating federally sponsored research and every two years thereafter;138 and requiring institutions to post on their publicly acces­ sible websites a listin~ of all instances in which they had determined the existence of a fcoi. 13 what did not appear in the nprm, but was ques130. see nih requests comments on proposed amendment of regulations on there­ sponsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors, nat'l inst. of health, http://grants.nih.gov/grants/guide/notice-files/not-od-09-099.html {last visited jan. 25, 2011). 131. see responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors, 75 fed. reg. 28688 {proposed may 21, 2010), available at http://edocket.access.gpo.gov/ 2010/pdf72010-11885.pdf. 132. see, e.g., id. at 28691 {proposing that the cap for sfi's be reduced to $5,000 as opposed to the aforementioned $10,000 cutoft). 133. see id. 134. seeid 135. see id. at 28690. 136. see id. at 28696. 137. see id. at 28694. 138. see id. at 28705-06. 139. see id. at 28697-99. 2011] financial conflicts of interest in academic medicine 39 tioned in the anprm, was a requirement that institutions develop and im­ plement lfcoi policies. concerted push back from the community had, in my view correctly, convinced the agency that putting such an explicit re­ quirement in the proposed rule would still be premature. the community submitted abundant comments in response to the nprm; interested readers can review these ad libitum on the nih docket. 140 numerous modifications, with which i agreed, were requested in the pro­ posed requirements, some of them substantive, many objecting to unduly onerous details of implementation. for one example, there was near­ unanimous opposition to the web-posting requirement, mainly on the grounds that having a fcoi is per se neither illegal nor a violation of aca­ demic or scientific standards, nor is it a judgment about a person's charac­ ter, and that the postings would yield no legitimate benefit but would constitute needless and potentially damaging violations of the privacy of the faculty members involved. for me, the most threatening proposal is the requirement that institutions provide nih with details about the instances of fcois they determine, their review processes, their judgments made and decisions reached about the relevance and seriousness of the fcois, and their final dispositions by some mix of elimination, reduction, or manage­ ment. because the determination of fcoi is ultimately a judgment call, as are the particulars of its disposition, and there are no black and white lines to trespass (as there are, for example, in scientific misconduct), providing these details to nih can only lead to "second-guessing" and disagreements by administrators far removed from the scene. in the comment letter sub­ mitted from harvard university dated august 19, 2010 we urged that nih engage the community to develop a formatted template on which mutually agreed minimum necessary information would be submitted to the agency, uniformly and in all instances.141 "minimum necessary" is the key to pre­ venting the agency from launching fishing-expeditions that would exceed­ ingly contentious, enormously wasteful of time and resources, as well as good will, and lead to no good end. xn. concluding remarks it is now more than three decades since an unfortunate succession of highly publicized cases of scientific misconduct, some coupled with egre­ gious fcois, brought these behaviors to the attention of the congress and administration and led to the first federal intrusions into the jealously pro­ tected space of oversight of the conduct of federally sponsored scientific research by university faculty. the regulation on scientific misconduct 140. see id. at 28688. 141. letter from harvard university, to the national institutes of health (aug. 19, 20 10) (on file with the author). 40 indiana health law review [vol. 8:1 was issued in 1989, that on individual financial conflicts of interest, in 1995.142 the basic contours of those regulations and their carefully negoti­ ated limits to the extent of intrusion have remained substantially unchanged during the past more than 2 decades. to quote from my 2000 jama. com­ mentary on fcois, previously cited: nonfinancial and financial conflicts that can affect re­ search differ in another important way: the oversight of nonfinancial conflicts traditionally has been left to the academic community and the professions, but dur­ ing the past decade financial conflicts have become a shared and contingent responsibility of academe and the federal government. the academic community has reluctantly acknowledged the government's legit­ imate interest in the issue, while arguing successfully that that interest be circumscribed to ensure that re­ search is conducted with integrity and in compliance with federal laws and regulations, and that data sup­ porting decisions that affect public health are sound and trustworthy. these boundaries, however, are not fixed, but contingent on the diligence of the academic community in meeting the responsibilities that ac­ company its fiercely defended claim to the privilege of self governance and academic freedom. 143 i submit that the brief history presented here of fcois in l;lcademic medicine, whence they came, where they went, and where they are, pro­ vides vivid substantiation of this admonition. as the community awaits the imminent publication of nlll's new rule on fcois, continues to debate the significance of fcois as threats to integrity across the scientific disciplines, struggles to identify the least bur­ densome ways of detecting and responding to fcois effectively but propor­ tionately, and continues to shy away from the perhaps insoluble issue of institutional fcoi, i leave the reader to ponder several conundrums that i find vexing regarding the academy's conception of the importance offcois in biasing academic work and its response to the federal rule: 1. how much attention would the academy give to faculty mem­ bers • outside financial interests and the potential conflicts they may raise if it were not for federal concerns and federal regula­ tion? 2. accept the propositions that fcois can threaten the integrity of 142. see discussion supra part ill. 143. kom, supra note 38, at2234-35. 2011] financial conflicts of interest in academic medicine 41 research, the well-being of human and animal research subjects, the integrity of the research training environment, the well­ being of students and trainees, individual and institutional repu­ tations, as well as the well-being of the public; that the goal of the 1995 rule is to "promote objectivity in (nih-sponsored] re­ search,"144 and the rule nowhere singles out research on hu­ man subjects as being exceptional; but that for the public, perceived threats to the wellbeing of human research subjects clearly trump all other considerations. what should be the uni­ versities' overarching goals in implementing fcoi policies? should they be more robust than merely to comply with federal regulations? 3. can/should an institution credibly discriminate among the ele­ ments listed in the preceding bullet, weigh their importance dif­ ferently, and fashion their fcoi policies accordingly. how does the importance of protecting research subjects' wellbeing compare to that for protecting the integrity of the research liter­ ature? and before answering consider that biased published re­ sults about the efficacy/safety ratio for a new therapeutic or the tensile strength of a structural support can harm or kill dozens or hundreds, or thousands of persons. 4. in an era of rapidly increasing understanding of the scientific foundations of influence and reciprocity, and of col, why do the government and academy continue to share the pretense that they can meaningfully define pre-specified levels of financial interests as "significant" irrespective of context? 5. all fcoi policies begin with the requirement of "disclosure," but recent research from professor george loewenstein's group145 and others shows that disclosure, far from leading a recipient to discount advice, can actually increase the stature of the adviser and the impact of the advice. how should the acad­ emy deal with this unexpected new insight? 6. how should the academy deal with the "conflict of public ex­ pectations?" how can universities and academic medical cen­ ters remain trusted, "independent arbiters of knowledge" while simultaneously fulfilling steadily intensifying public expecta­ tions that they be engines of economic development in our capitalistic economy? is there an unmet role that the govern­ ment could play in creating "buffer zones" or "safe interfaces" that would help to protect the independence and credibility of research universities while ensuring that technology transfer 144. see 45 c.f .r. § 94.1 (2009). 145. see discussion supra part xi. 42 indiana health law review [vol. 8:1 thrives? 7. can "assurance" survive as the foundation -of the federal­ academic research partnership in the 21st century? sarah davis sarah davis is clinical assistant professor of law and associate director of the center for patient partnerships at the university of wisconsin where she teaches about patient advocacy, health policy and law, and professional ethics. areas of interest include the emerging field of patient advocacy, healthcare teamwork/collaboration, an4 the responsiveness of the health care system to consumers' experiences. ms. davis also serves as co­ director of the jd-mph dual degree program. ms. davis current research projects include building an e-archive of litera­ ture on health advocacy and a qualitative study of state-level consumer as~ sistance programs under health care reform. she also serves as a consultant to health care organizations engaging patients in improvement efforts. pub­ lications include: "educating for health advocacy in settings of higher education" in patient advocacy for health care quality: strategies for achieving patient-centered care, jones and bartlett publishers, inc. and "ten strategies to build partnerships with patients,'' wisconsin medical journal. the center for patient partnerships, an interdisciplinary center of the schools of law, medicine and public health, nursing and pharmacy, offers experiential patient advocacy education to students from those disciplines and others. the curriculum focuses on health advocacy, patient-centered care, and health systems change, offering a 12-credit certificate in consum­ er health advocacy. the center also infuses patients' voices into health systems reform, offering a critical link to health consumers' experiences. kathleen g. noonan kathleen g. noonan, jd, is clinical associate professor at the university of wisconsin school of law with a focus on health and government law. before coming to madison, she was founding co-director of policylab, a cross-disciplinary research and policy center focused on children's health and well-being at the research institute of the children's hospital of phila­ delphia. she was also adjunct faculty for the robert wood johnson clini­ cal scholars program at the university of pennsylvania and taught in the masters in public health program. before joining chop, kathleen spent seven years as a senior associate and engagement manager with casey strategic consulting, the consulting ann of the annie e. casey foundation. while at casey, kathleen led engagements around the country aimed to produce significant public system reforms for the benefit of vulnerable children, families, and communities. earlier in her career, kathleen was a practicing attorney at the boston firm of hill & barlow. she served as a law clerk to united states district judge morris e. lasker and has worked in public policy positions in new york city with the citizens' committee for children ofnew york, inc., and bank street college of education. law in action: learning health law through experience with stakeholders at the patient and . , system levels kathleen g. noonan· & sarah davis•• i. introduction ••.•..•.•...........•.•••..•••••...•••...••••...••••...••••...•..••..•...••.••• 559 ii. the centerforpatienrpartnerships .................................... 561 iii. the government and legislative clinic ...••..••••••.•....•.••.•.•.... 564 iv. conclusion ..•.••.....•••...•.•.....••••...••••..••••...••••..•••••...•••••..•..•....••..•... 566 i. introduction one of the hardest things about teaching health law is conveying the breadth of, and interactions among, stakeholders involved in the field. health ·law is about the very private interaction between a patient and a doctor,' but it is also the study of how these interactions are authorized, paid for, and monitored through a complex and layered world of govern­ ment, nonprofit, and for.:.profit actors. knowledge about the patient-doctor relationship alone will not prepare a law student to work effectively with any of the hundreds of stakeholders affected by health law, including medi­ cal professionals, insurance companies, hospitals, consumer groups, gov­ ernment agencies and, perhaps most important, patients. students learn this best through a combination of classroom learning and experiential opportu­ nities with clients and other health and public health stakeholders. two clinical programs at the university of wisconsin law school provide these experiences to students interested in health law, the center for patient partnerships ("cpp") and the government and legislative clinic ("glc"). each clinic has as a core goal teaching law students about health law in a real-world setting of competing stakeholder interests. the clients at cpp are patients or their caregivers. the glc, on the other hand, engag­ es legislative and administrative clients. together, the clinics embody the inherent tension of health care: the desire to meet the health-care needs of individuals, on one hand, versus the need to develop, regulate, and provide care with a systemsor population-level focus, on the other. this is also a tension the patient protection and affordable care act ("ppaca") attempts to manage. the law promises new levels of account­ ability and quality at the health systems level through provisions related to• clinical associate professor at the university of wisconsin law school. •• clinical assistant professor at the university of wisconsin law school. i. we use "doctor" as a proxy for any health care provider, e.g., nurse, physical ther­ apist, etc. 560 indiana health law review [vol. 9:2 -among many other things-the creation of accountable care organiza­ tions ("a cos"), bundled payment initiatives, and the creation of the medi­ care independent payment advisory board. the hope is that health systems, through better tracking of the care they deliver and the outcomes that result :from that care, will become more efficient and effective at what they do. simultaneously, the ppaca lauds a model of care that harkens back, in some respects, to the notion of a family doctor through the creation of "patient-centered medical homes." the "medical home" will track and be responsible for the care of its patients, and its patients will view their medical home as the hub of their health care, the ppaca also aspires for · patients to become more engaged in their care through the availability of their own medical records, the publication of quality information about their provider systems and doctors, and enhanced consumer assistance for insur­ ance selection and disputes. as a practical matter, the ppaca, creates a range of opportunities for students to engage these tensions on the ground, and to learn how, as law­ yers, to help manage them. in the case ofcpp, the ppaca provides new federal legal rights and protections-which students must first understand themselves in the context of state law and existing practice-and then con­ vey in an accessible way to patients. in the case of glc, pp aca presents important opportunities for students to assist public sector agencies in­ volved in health care to learn how to anticipate, interpret, and respond to the changes ppaca will (likely) bring. in the process, this also teaches stu­ dents an important lesson about the systemic role of lawyers: they are often the ground-level agents who implement change, strategically positioned to influence law in action. knowledge of various stakeholder interests and the range of policy choices is critical for these attorneys, and students interfac­ ing with these agencies witness these tensions play out in real time. both the center for patient partnerships and the government and leg­ islative clinic build on an approach to legal education at the university of wisconsin that has been characterized as "law in action."2 the hallmark of this approach to teaching is that students learn not only legal rules, but also why those rules evolved to address social concerns, and how those rules operate in the real world. more than this, the clinics attempt to continue one of the longest and deepest traditions surrounding the university of wis­ consin, the wisconsin idea, a principle that the university should improve people's lives in the state beyond the classroom and that citizens ofthe state have rich wisdom to share with students.3 students in both clinics benefit immensely :from the experiences of the patients and lawyers they serve. the clinical models we describe below are· novel in certain important 2. our law-in-action tradition, univ. of wis. law sch., http://www.law.wisc.edu/ law-in-action! (last updated july 29, 2011). 3. gwen drury, the wisconsin idea: the vision that made wisconsin famous (2011), http://www.ls.wisc.edu/documents/wi-idea-history-intro-surnmary-essay.pdf. 2012] learning heal 1h law tiirough stakeholders 561 respects, advancing our understanding of what legal clinics can and should do, and the role they can (and should) play in the law school. cpp is one of a handful of truly interdisciplinary clinics, engaging the services of (and creating opportunities for) not merely law students but also medical, phar­ macy, public affairs, public health, and even non-traditional students ... ln­ terdisciplinarity" is an increasingly important part of the missions of many law schools, 4 and cpp shows how this can be accomplished in clinics. glc shares other innovative aspects with cpp: both clinics break funda­ mentally from the litigation-centered, adversarial model that has formed the important core of clinical legal education for many years; they have also attracted many joint degree students who want to apply their legal training in interdisciplinary settings. 5 legal academics increasingly recognize that legal education can and should play an important part in the legislative and regulatory process. glc brings that alive for students. the following de­ scribes each of our clinics in greater detail. ti. the center for patient partnerships cpp was founded in 200 l on the belief that to reform our health care system, future professionals-lawyers, health care providers, policy mak­ ers, and others-need to truly understand both the patient perspective and the value of partnership in health care.6 following her own diagnosis and treatment for ovarian cancer, martha "meg" gaines, a uw-madison clini­ cal law professor transformed her own self-advocacy experience into a model for consumer-centered patient advocacy. along with colleagues from the schools of medicine and nursing, and a professional health and human services public administrator/ she recognized the potential of advo­ cacy training, drawing on the pedagogy of clinical legal training and the 4. margaret martin barry et al., clinical education for this millennium: the third wave, 7 clinical l. rev. 1, 65-67 (2000) ("newer lawyering models, which shift the focus from vindication of legal rights and injuries to creative problem solving, stress the need to transcend doctrinal areas, legal fora. and professional disciplines to fully address client prob­ lems."). 5. see roy t. stuckey, best pracitces for legal education: a vision and a road map (clinical legal educ. ass'n ed., 2007), available at http://law.sc.edu/faculty/ stuckeylbest_practiceslbest _practices-full. pdf. 6. see jo harkness, patient involvement: a vital principle for patient-centered health care, 41 world hosps. & health servs. 12, no. 2, 2005, at 12-16, 40-43; see also moira stewart et al., patient-centered medfc!ne: transforming the clinical method (2d ed. 2003); jody heymann, equal par'iners: a physician's call for a new spirit of medicine ( 1995). 7. co-founders include: barbara bowers, rn, phd, professor ofnursing and associ­ ate dean for research, and linda reivitz, mab, faculty associate, university of wisconsin school of nursing; julian c. schink, md, professor of medicine, northwestern university school of medicine; helene nelson, secretary, wisconsin department of health & social services; timothy harrington, md, department of medicine university of wisconsin­ school of medicine and public health. 562 indiana health law review [vol. 9:2 experiential emphasis of health professional and social work training to in­ troduce students to our health care system through the patient's eyes. three full-time and three part-time faculty, working with other volun­ teer professionals, supervise students and provide expertise in law, medi­ cine, nursing, health policy, public affairs, industrial engineering, and education. cpp does not litigate or directly participate in any court pro­ ceedings; students participate in informal and formal negotiations (such as internal insurance appeals) and support clients in social security disability insurance applications and reconsiderations. students also learn preventa­ tive and problem-solving skills-with a specific emphasis on holistic solu­ tions. students· spend at least twelve hours a week during their first semester and are encouraged to make a two-semester commitment continu­ ing for at least four, but usually eight to twelve hours. professional and graduate students who study at cpp provide free ad­ vocacy services for clients with serious chronic or life-threatening illness­ es.8 while students are learning patient advocacy, they gain cross-cutting competencies and skills applicable to lawyering and other health care pro­ fessions.9 the cpp model includes four principal educational objectives: (1) kinesthetic understanding of how consumers and other stakeholders ex­ perience the health care system; (2) skills for effective patient-centered ad­ vocacy and problem-solving;10 (3) a commitment to life-long learning11 and reflective practice;12 and (4) tools to work collaboratively across disci­ plines.13 cpp placed particular emphasis on problem solving, underscoring 8. cpp's advocacy model focuses on helping clients build their own skills and capac­ ity to navigate the health care system and triake decisions based on their values and priori­ ties. cpp clients include patients or spouses, adult children, parents, life partners, neighbors, and others caring for critically ill loved ones. effective consumer-centered patient advoeacy supports patients as they make informed decisions, access necessary health care, and build . strong partnerships with providers. see generally advocacy services: our patient advocacy services, ctr. for patient p'ships: univ. of wis.-madison, http://www.patientpartner sbips.orgladvocacy/our-setvices/overview/ (last visited apr. 12, 2012). . 9. stuckey, supra note 3, at 19 (citing wiluam m. sullivan, amm colby, judith welch wegner, lloyd bond, & lee s. sjrjlman, educating lawyers: preparation · for the profession of law 2 (2007)) ("the core goal of legal education should be the same as all other forms of professional education, which [is] •.. 'to initiate novice practitioners to think, to perform. and to conduct themselves (that, is to act morally and ethically) like pro­ .fessionals.'") see generally marsha hurst et al., educating/or health advocacy in settings of higher education, in patient advocacy for health care quality: strategies for achieving patient-centered care 481, 488 (joanne l. earp et al. eds., 2008) {describ­ ing cpp's "complementary'' educational model). 10. stuckey, supra note 3, at 279 ("the second year should continue helping students develop legal problem-solving expertise, self efficacy, and self-reflection and lifelong learn­ ing skills. j. 11. see generally stuckey, supra note 3, at 6; richard k. neumann, jr., donald schon, the reflective practitioner, and the comparative failures of legal education, 6 clinical l. rev. 401, 404-05 {2000); donald a. schon, educating the reflective practidoner: toward a new design for teaching and learning in the professions (1987). 12. stuckey, supra note 3, at 196. 13. marsha m. mansfield & louise g. trubek, new roles to solve old problems: 2012] learning health law through stakeholders 563 that clients' presentation of a problem may not be the most accurate or use­ ful framing; problems often have a creative/non-legal resolution; as profes­ sionals, our inherent judgments and bias about clients or situations can deeply influence our efficacy; and, working in teams or running scenarios by colleagues-informally or in formal "case staffings" can dramatically increase the quality of advocacy. rather than expecting students to become well-versed in all substan­ tive areas of health law and advocacy, students learn how to identify issues and research key substantive knowledge grounded in the facts relevant to their client. students also learn to assess client needs, help clients mobilize resources, and support client decision-making. students learn core advoca­ cy (and clierit services) skills, including how to empathize, listen actively, respect client confidentiality, communicate effectively with clients and oth­ er professionals, help clients and families build their own capacity as advo­ cates, maintain professional ethics, interview clients effectively, and manage complex cases. students quickly learn about the stakeholder tensions inherent in the health care system from their clients' experiences. common tensions in­ clude seemingly competing interests: of employer (purchaser of health in­ surance; responsible for work productivity) and employee (sick client); providers (facing time pressures) and patients (wanting to participate in shared-decision making); or insurers (shareholder pressures to increase profits) and hospitals (need for timely and predictable compensation). led by the model of "partnership," whenever possible, cpp teaches students to approach such tensions by seeking common ground. for example, for the employer and employee, what value can the employee add while benefiting from the flexibility afforded by intermittent leave under family medical leave act protections? for the provider and patient, how can the patient arrive for an appointment prepared and activated to use their time together efficiently and effectively, and how can the provider effectively harness technology and teamwork to meet the patient's needs? · learning from client experiences, cpp also promotes consumer­ centered changes in local, regional and national health systems and policies. for example, cpp collaborated with local stakeholders to secure state legis­ lation to prohibit insurance companies from discontinuing routine coverage when wisconsin patients enter clinical trials. in another example, discus­ sions with a local insurance company motivated them to inform beneficiar­ ies more clearly about the date coverage begins. all students participate in a significant "advocacy project" assignment where they are encouraged to explore advocacy beyond their work with individual clients. in all "case to cause" activities, students learn first-hand the power of effectively harness­ ing patient anecdotes and capturing trends in individual experience to adlawyering for ordinary people in today's context, 56 n.y.l. sch. l. rev. 367, 371-77 (20 11) (describing new roles for lawyers, including the role of collaborator). 564 indiana health law review [vol. 9:2 vance changes that benefit many. the center for patient partnerships' patient advocacy clinical also forms the core of a twelve-credit certificate in consumer health advocacy, which requires a course on systemic models of health advocacy, related elective coursework, and a capstone project. completion of the certificate demonstrates a concentration in health advocacy and is notated on each stu­ dent's transcript. in addition to the clinical opportunities, law students and others can participate in cpp's scholarship and policy initiatives. current­ ly, a dual-degree law/public affairs student serves as a project assistant on a qualitative research project on state consumer assistance programs ("caps"). the ppaca provided a one-year grant for states to develop or expand existing caps to serve consumers with inquiries and disputes re. garding state regulated health insurance. that student is learning about the tremendous state-by-state diversity in: program structure, legal and regula­ tory authority, and resources for consumers. a major theme of the caps story is stakeholder tensions: federal government (ppaca) aspirations verses individual state visions; administrative agency authority verses legis­ lative agendas; and consumer needs verses system resources. iii. the government and legislative clinic the government and legislative law clinic ("glc") was launched in spring 2010 to provide law students with the unique opportunity to ob­ serve and participate in the many facets of governmental law, policy, and the legislative or agency process, including health and public health. (glc was launched by kathleen noonan, one of the authors, who came to uw · from the children's hospital of philadelphia, where she co-founded pol­ icylab, a children's health policy research center). working under the dual supervision of clinical faculty and clients in legislative and administrative agency settings, students gain first-hand experience working with govern­ ment clients on legal issues with policy significance. the glc requires a minimum commitment of sixteen hours each week, divided between twelve hours of client work (often on site), and four hours divided among time dedicated to a clinical seminar, one-on-one. supervision sessions and class ·assignments. from a skills perspective, the clinic focuses on the development of ''policy lawyering" competencies, meaning the development of new laws, regulations, and policies rather than on litigation, for which there are al­ ready numerous clinical offerings. the glc emphasizes several core themes with students: (1) the work of a government and legislative policy lawyer typically involves policy choices, which means that there is often not a ''right" answer but many possible answers based on the criteria most important to your client (e.g., values, efficiency, cost, evidence); (2) the work of a government and legislative policy lawyer requires attention to the interests and needs of multiple constituencies (e.g., voters, agency leader2012] learning health law through stakeholders 565 ship; the governor's office, etc.); and (3) the work of a· government and leg­ islative lawyer involves particular constraints that may not exist in a typical lawyer-client relationship due to the government context. health law, as noted above, featured prominently in the glc from the start. student interest in health experiences was strong, in part, because of passage of the ppaca and-perhaps more importantly-because of in­ creased awareness about the number of post-graduation jobs in the health sector. the clinic engages health•related clients based on both student in­ terest and our own diligence about client needs. we call this combination our "match process" in which we screen potential clients and students to find an appropriate fit. for example, we knew that our state health and in­ surance departments would be working in some capacity on health care so contacted them about potential projects before we had students identified for the work. students come to the clinic seeking a wide variety of health-related experiences. some are interested in public health, biotech or health ser­ vices, others with compliance or information technology. others find the area of health care and health law of interest, but need help translating their interest into a job. we do not require that students have taken introduction to health law to work with our health clients, though it helps when they have done so. where students do not have a background in health or health law, clinical faculty insure students have some introductory reading materi­ als before they begin their client work. the "match" process is a major part of the work of the glc. for ex­ ample, a joint degree jd-mph student was matched with a former state health secretary leading an effort related to health care bundled payment reform because of the student's interest in health system design and quanti­ tative methods. another jd-mph was matched with a state health depart­ ment project related to developing new obesity prevention policies with local schools. both "matches" involved students with non-traditional legal interests: each wanted to leverage their legal training in a health care con­ text but also apply their public health training and especially social science methods. the glc matching process allowed us to identify settings in which their knowledge of law was important but the skills used on the ground involved the quantitative methods they learned in their public health programs. confidentiality and non-partisanship are critical to the success of a clinic like glc. the first assignment for every glc student is adapting a form confidentiality agreement with their client. like other clinics, the glc is set up so that the students and clinical faculty are, for all intents and purpose, a small ftrm with all the responsibilities and confidentiality protec­ tions typically associated with that. the glc and clients sign confidentiali­ ty agreements each semester that allow students to discuss in the weekly seminar the issues they working on with their client. on occasion, students are involved in matters that require them to refrain from discussing their 566 indiana health law review [vol. 9:2 work in the seminar. we assure clients that we will accommodate this type of discretion and create firewalls, as necessary, to provide clients with the comfort they need to work with us. because some of the work is highly confidential and/or controversial, there are times when a client requests a student not share information until it is also available to the public. in addition to assignments that students receive from glc clients, the clinic itself includes skills training applicable to the range of government and legislative clients. the students' first assignment is to understand the purpose and authority of their client. for example, a student working with the department of health would be required to come to the seminar pre­ pared to report whether its clients' powers are derived from the state consti­ tution or state statutes, or both. it is also critical that students understand the operations of their clients: how many staff they employ, the organiza­ tional structure, and budget. a second assignment involves asking students to consider all of the stakeholders connected to their client. the purpose of this is to help students understand that government clients have multiple constituencies to whom they answer and various interests to weigh in decid­ ing how to solve a problem. this is especially important for students to understand where they are dealing with a problem that has no "right" legal answer. given the number of glc students involved in health care, we have also used a stakeholder exercise related to the implementation of the ppaca. for this project, students are given the names of five organiza­ tions involved in health care. the list includes provider groups, trade asso­ . ciation, labor organizations, advocacy groups, etc. each student is given a diverse group of stakeholders to reflect the various and complex positions about the ppaca. the assignment for the student is to consider how as general counsel to the health department, office for the commissioner of insurance or the governor's office they can provide advice given the vari­ ous opinions of stakeholders, including those unrepresented. this type of assignment helps students understand the difficulty of balancing the various interest groups concerned with health and public health issues. n. conclusion while focusing primarily at different levels of influence-micro (the patient and interpersonal interactions) for cpp and macro (organizational and policy) for glc both clinics teach about the various roles of key healthcare stakeholders and offer critical competencies for 21st century lawyers working in the healthcare sector. our approaches and pedagogy complement each other----offering wisconsin students interested in health law experiential education covering the full spectrum of legal roles. both programs strive to ensure that future health lawyers will work effectively with diverse stakeholders at the individual patient and system level you don’t have to go home, but you can’t eat here: how restaurants discriminate against individuals with celiac disease under the americans with disabilities act and what should be done michael j. hooker* i. introduction ................................................................. 856 ii. a background of celiac disease and argument for protection ........................................................................ 858 a. celiac disease ............................................................ 858 b. the americans with disabilities act ........................ 863 c. restaurants: the missing link ................................. 867 d. putting it all together .............................................. 868 e. conclusion .................................................................. 870 iii. the lesley university settlement: a preview of things to come for restaurants ................................... 871 a. the agreement ........................................................... 871 b. applying this analysis to restaurants: cause for concern ........................................................................... 875 iv. disproportionate protection: why the ada as applied by the doj creates a double standard by protecting certain disabilities more than others and what should be done. ..................................................... 879 a. a truly protected disability ..................................... 879 b. lack of protection for celiac sufferers ..................... 883 c. what should be done ................................................ 884 d. lessons from abroad ................................................. 889 e. solutions for the cost of compliance ........................ 890 f. crime and punishment .............................................. 891 v. conclusion ................................................................... 892 * j.d. candidate, 215, indiana university robert h. mckinney school of law; b.s., 2011, butler university college of business. the author would like to give special recognition to kathleen m. kelly, j.d. along with being his fiancé, she is also a celiac disease sufferer, and the inspiration behind this note. http://dx.doi.org/10.18060/3911.0010 856 indiana health law review vol. 12:2 i. introduction imagine an america where restaurants were not accessible for people in wheelchairs. trying to share a meal with friends or family could lead to the discovery that, not only is there no way to get the wheelchair up to the restaurant without it being carried up the stairs, but there also is not enough room to maneuver it around once inside. the embarrassment and frustration that this could cause nationwide would be appalling. luckily, the government has taken measures through the americans with disabilities act (“ada”) to prevent this from happening. one product of the ada is a long list of specifications providing accessibility standards, such as wheelchair ramp/accessibility mandates as well as walkway width requirements inside of the restaurants, to ensure that physically disabled individuals can equally participate in the restaurant dining experience. conversely, there is another group of individuals that are much more discretely excluded from sharing meals with friends and family at many of the nation’s restaurants. it is not because they are physically unable to maneuver around the restaurants, but rather that the majority of restaurants in the united states choose not to offer a meal option that is safe for consumption by them without the risk of severe sickness and life-threatening intestinal damage. discrimination against people who suffer from celiac disease, those who cannot consume products containing wheat, oats, barley, or rye, may not be as openly visible as the previously provided example of discrimination, but it is far more common. most restaurants that try to offer meals to accommodate this autoimmune disorder fail to actually accommodate those inflicted with it because they include disclaimers on their menus stating the restaurant cannot guarantee the food is safe for consumption by people with the disorder due to potential cross-contamination. this would be similar to a restaurant having a wheelchair ramp with a sign posted at the foot of the ramp stating that the restaurant cannot guarantee the structural integrity of the ramp, so use at your own risk. consequently, the united 2015 how restaurants discriminate 857 states department of justice (“doj”) should use the ada to guarantee the same type of protections to americans that suffer from celiac disease as are offered to the physically disabled. there has been a long running debate regarding which mental and physical impairments qualify for protection under the ada. many court cases, discussed later, were decided based on a narrow and strict interpretation of what constitutes a disability for purposes of the ada. eventually, congress recognized that the narrow interpretation went against the overall policy rationale of the ada and amended the law in order to limit courts’ discretion in interpreting which disabilities should receive protection. the ada amendments act of 2008 vastly broadened the scope of impairments that are to be protected under the ada by including things such as eating as a “major life activity” and providing that anyone who is “substantially limited” in doing so should be considered to be “disabled” for purposes of the law. the awareness and diagnosis of celiac disease, an autoimmune condition has also grown tremendously in recent years. because of the symptoms of the disease and the ada amendments act of 2008, its “protected status” under the ada has become an unavoidable issue. for americans, eating out has arguably overtaken baseball as the national pastime. however, acknowledging celiac disease as a disability could create many potential obstacles for restaurants trying to cash in on americans’ eating habits. recently a settlement was reached between lesley university and the united states based on an alleged ada violation because the university was not providing gluten free options for sufferers of celiac disease that attended the school. 1 the question of how this settlement will impact the obligations of the restaurant industry to provide gluten free options remains. the impact could potentially be that places of public accommodation that serve food, such as restaurants, will be required to 1 settlement agreement, united states v. lesley univ., dj 202-36231 (dec. 20, 2012), available at http://www.ada.gov/ lesley_university_sa.htm [hereinafter settlement]. 858 indiana health law review vol. 12:2 provide a certified gluten free menu in order to avoid discriminatory practices as classified by the ada. the remainder of this note discusses the new found necessity to offer the protections of the ada to individuals with celiac disease, specifically in the context of dining at restaurants. to increase the reader’s understanding of how these things are interrelated, part ii sets forth a background of celiac disease as well as a background of the ada along with how it applies to restaurants. part iii provides an analysis of a recent settlement agreement reached between the doj and lesley university that illustrates one of the first suggestions by the doj that celiac disease is a protected disability under the ada. the implications of the terms of the settlement agreement for the restaurant industry are also discussed in part iii of this note. a comparison between the modifications that restaurants are mandated to make by the ada for the physically disabled requiring the use of mobility devices and the modifications currently mandated for individuals with celiac disease is drawn in part iv to show the disparity in the standards. part iv then explains what should be required of restaurants in order to avoid discriminating against sufferers of celiac disease including following the lead of innovative restaurants as well as government programs in other countries. ii. a background of celiac disease and argument for protection a. celiac disease celiac disease, also known as celiac sprue, non-tropical sprue, and gluten-sensitive enteropathy, is an inherited genetic disease.2 sufferers of celiac disease cannot tolerate the protein gluten, which is found in wheat, oats, barley, and rye.3 ingesting even trace amounts of gluten triggers 2 celiac disease, nat’l inst. of diabetes & digestive & kidney diseases, http://digestive.niddk.nih.gov/ddiseases/pubs/celiac/ (last visited mar. 22, 2015) [hereinafter nat’l digestive diseases]. 3 id. 2015 how restaurants discriminate 859 an autoimmune reaction in which the body produces antibodies that attack and destroy the villi in the small intestine causing a wide array of gastrointestinal symptoms.4 villi are the “tiny, fingerlike protrusions lining the small intestine” that absorb the nutrients from food into the bloodstream, and without them, a person will become malnourished regardless of the amount of food he or she eats.5 because of this, it is easy to see the life threatening consequences that exposure to any amount of gluten can have for an individual with the disease. blood testing, genetic testing, and biopsies of the small intestine are all common ways of diagnosing celiac disease.6 symptoms can vary widely from person to person.7 among children, it is more likely that the symptoms will manifest in the form of digestive issues such as diarrhea, abdominal pain/bloating, and vomiting.8 however, adults can show a wide variety of symptoms ranging from joint pain to iron deficiency to depression and even seizures, none of which would lead someone to think the food he or she had been consuming was the root of the problem.9 the disease can be life threating and cause problems such as increased risk of certain types of cancer, osteoporosis, nervous system disease, pancreatic disease, and various organ disorders.10 the importance of getting tested cannot be overstated due not only to the intestinal damage that can be caused, but also because of the elevated risks of other diseases that 4 center for celiac research & treatment: gluten sensitivity faq, massgeneral hosp., http://www.massgeneral.org/children/ services/celiac-disease/gluten-sensitivity-faq.aspx (last visited mar. 22, 2015) [hereinafter gluten sensitivity faq]. 5 nat’l digestive diseases, supra note 2. 6 gluten free diet fad: are celiac disease rates actually rising?, cbsnews (july 31, 2012, 5:13 pm), http://www.cbsnews.com/news/gluten free-diet-fad-are-celiac-diseaserates-actually-rising/. 7 nat’l digestive diseases, supra note 2. 8 id. 9 id. 10 center for celiac research & treatment: celiac disease faq, massgeneral hosp., http://www.massgeneral.org/children/services/ celiac-disease/celiac-disease-faq.aspx (last visited june 16, 2015) [hereinafter celiac disease faq]. 860 indiana health law review vol. 12:2 have been linked to celiac disease as well as the multitude of symptoms through which the disease can manifest. as previously mentioned, celiac disease is an inherited genetic disorder, but it can either be active in an individual at birth or lay dormant and be triggered by a later life event that is a stressor to the body.11 there have been some gene mutations identified that apparently increase the risk of potentially developing the disease, but just having one of these genetic mutations does not guarantee that a person will develop celiac disease. 12 for these people who are genetically predisposed to celiac disease, it can become active after the body experiences one a stressful life event, as mentioned above, such as surgery, childbirth, pregnancy, viral infection, or even severe emotional distress.13 celiac disease “may be one of the most common genetic diseases” as it affects an average of 1 in 133 average americans.14 one in thirty-nine people that have an aunt, uncle, or cousin (second-degree relative) with celiac disease also have it themselves.15 americans with a first-degree relative who suffers from the disease have a one in twentytwo chance of also having it themselves.16 these numbers show that as people in genetically predisposed families continue to reproduce, it is only logical that the number of people with celiac disease will continue to grow in the united states and issues associated with it will become more and more unavoidable. another common term heard when discussing celiac disease is gluten sensitivity. many people use the term 11 nat’l digestive diseases, supra note 2. 12 celiac disease, mayo clinic (may 22, 2013), http://www.mayoclinic.org/diseases-conditions/celiacdisease/basics/causes/con-20030410. 13 id. 14 laura e. derr, when food is poison: the history, consequences, and limitations of the food allergen labeling and consumer protection act of 2004, 61 food & drug l.j. 65 (2006). 15 celiac disease facts and figures, univ. chi. celiac disease center, http://www.uchospitals.edu/pdf/uch_007937.pdf (last visited mar. 22, 2015). 16 id. 2015 how restaurants discriminate 861 interchangeably, but there is a distinct difference between people with celiac disease and those who are gluten sensitive. gluten sensitivity is a term used to describe people that react similarly to those with celiac disease after ingesting gluten, but do not experience the same intestinal damage caused by the production of attacking antibodies that celiac sufferers do. 17 it differs from celiac disease because the response of the immune system is innate, meaning that although the response is immediate, it has no “immunological memory” and will not cause an attack on the body’s own tissue like celiac disease does.18 essentially, people with gluten sensitivity have the same symptoms but without the long-term intestinal damage or the same elevated risks of many other diseases such as cancer and the other various organ diseases suffered by people with celiac disease that are listed above. 19 therefore, for the estimated eighteen million americans that experience nonceliac gluten sensitivity, it “has been clinically recognized as less severe than celiac disease.”20 food allergies are also a common topic of conversation in the realm of celiac disease and gluten sensitivity. food allergies are the result of the immune system deciding that a certain food is dangerous to the body, which can cause many of the same symptoms as celiac disease. 21 the reaction initiated by the immune system is typically shortlived and does not cause permanent harm to the body once reversed. 22 the exceptions to this generality are those allergies that cause anaphylaxis and can lead to death if not properly treated. 23 however, these reactions can be 17 what is non-celiac gluten sensitivity?, nat’l found. for celiac awareness, http://www.celiaccentral.org/non-celiac-glutensensitivity/introduction-and-definitions/ (last updated mar. 22, 2015). 18 id. 19 id. 20 id. 21 allergies and intolerance, univ. chi. celiac disease center, http://www.cureceliacdisease.org/wpcontent/uploads/2011/09/cdcfactsheets9_allergies.pdf (last visited mar. 22, 2015). 22 id. 23 id. 862 indiana health law review vol. 12:2 controlled through the use of a medication known epinephrine.24 therefore, even though the initial reaction may be as severe as that of a celiac disease sufferer, the symptoms are typically immediately reversible. there is currently no cure for celiac disease, nor is there a way to control the body’s reaction.25 thus far, the only treatment that has been discovered for the disease is a strict adherence to a gluten free diet.26 if this is done, the damage to the small intestine caused by gluten can be maintained and possibly reversed to some extent. 27 however, consuming any amount of gluten, even trace amounts that may not cause an attack evidenced by physical symptoms, can cause an elevation in levels of antibodies signifying intestinal damage, and it may takes weeks for those levels to return to normal.28 therefore, it is extremely important for the health and well-being of celiac sufferers to be absolutely sure that everything they eat, drink, or otherwise consume is 100% gluten free. 29 for many, this is a daunting challenge that presents many difficulties when eating out or travelling due to the lack of certified gluten free options in restaurants as well as a lack of restaurant staff training on how to handle and prepare food for individuals with the disease.30 the university of chicago celiac disease center is currently striving to remedy this problem by discovering a cure for the disease and hopes to do so by the year 2026, but as of now, the gluten free diet remains the only identified treatment.31 24 facts and statistics, food allergy res. & educ., http://www.foodallergy.org/facts-and-stats (last visited mar. 22, 2015). 25 what i need to know about celiac disease, nat’l inst. of diabetes & digestive & kidney diseases, http://digestive.niddk.nih.gov/ddiseases/pubs/celiac_ez/ (last updated sept. 11, 2013). 26 id. 27 id. 28 start on a gluten-free diet, univ. chi. celiac disease center, http://www.cureceliacdisease.org/living-with-celiac/guide/treatment (last visited mar. 22, 2015). 29 id. 30 id. 31 id. 2015 how restaurants discriminate 863 even though many foods are naturally gluten free, there are still many dangers associated with those foods for celiac disease sufferers.32 cross-contamination is often thought of in the sense of preventing the transfer of harmful bacteria from one object to another like bacteria from raw chicken to fresh vegetables that can cause food poisoning,33 but it can also be used to describe the transfer of allergens from one object to another.34 cross-contamination can occur in the manufacturing process, in the food preparation process, and/or while the food is being cooked. 35 if the food is processed in the same area as allergen-containing products, prepared with utensils that have not been properly cleaned since coming in contact with allergens, cooked on the same surface as food containing allergens, or even exposed to dust from nearby allergenic foods, it can be cross-contaminated and cause allergic reactions for consumers with celiac disease. 36 restaurants are a place where many celiac disease sufferers are at high risk of having their gluten free food cross-contaminated because there are an abundance of opportunities for cross-contamination to occur as well as a lack of employee training about how to safely serve those suffering from food allergies.37 for example, a restaurant that serves pizza and uses regular wheat flour when stretching and tossing the dough can contaminate every other surface in the kitchen due to the transfer of gluten via the particles of flour that get tossed into the air along with the dough. b. the americans with disabilities act in 1990, congress enacted the americans with disabilities act to “provide a clear and comprehensive 32 derr, supra note 14. 33 prevent cross-contamination, minn. dep’t of health, http://www.health.state.mn.us/foodsafety/clean/xcontamination.html (last visited mar. 22, 2015). 34 derr, supra note 14, at 85. 35 id. 36 id. 37 id. at 92. 864 indiana health law review vol. 12:2 national mandate for the elimination of discrimination against individuals with disabilities.” 38 a disability is defined as “(a) a physical or mental impairment that substantially limits one or more of the major life activities of such individual; (b) a record of such an impairment; or (c) being regarded as having such an impairment.”39 this enactment was based on the finding that “historically, society has tended to isolate and segregate individuals with disabilities” and that this “continue[s] to be a . . . pervasive social problem” while “discrimination against individuals with disabilities persists in such critical areas as. . . public accommodations . . . .”40 congress originally intended a very a broad scope of protection to be offered for individuals under the ada.41 however, in the later part of the 1990s and early 2000s, the supreme court interpreted the definition of disability very narrowly and excluded many individuals that congress had initially intended to protect.42 in sutton v. united airlines, the supreme court significantly narrowed the definition of a disability.43 in sutton, twin sisters each had severe myopia, (uncorrected vision of 20/200 or worse) “but with the use of corrective lens, each has vision that is 20/20 or better.”44 the sisters applied to be airline pilots, but were denied the opportunity because they did not meet the airline company’s minimum uncorrected vision requirement of 20/100.45 as a result, the women filed a charge of disability discrimination under the ada.46 the court decided the women were not actually 38 42 u.s.c. § 12101(b)(1) (2015). 39 id. § 12102(1). 40 id. § 12101(a)(2)-(3). 41 ada amendments act of 2008, pub. l. no. 110-325, 122 stat. 3553 (2008). 42 id. 43 sutton v. united airlines, inc., 527 u.s. 471 (1999), superseded by statute as stated in, rohr v. salt river project agric. imp. & power dist., 555 f.3d 850, 853 (9th cir. 2009). 44 id. at 475. 45 id. at 476. 46 id. 2015 how restaurants discriminate 865 disabled in the context of the ada based on the reasoning that a disability only substantially limits a major life activity if the physical or mental impairment cannot be corrected by medication or other measures. 47 therefore, because the women had glasses that corrected their severe myopia, they were not protected by the ada. in toyota motor manufacturing, kentucky, inc. v. williams , an employee of an automobile manufacturer was diagnosed with bilateral tendinitis, among other various nerve and tendon conditions, after performing functions of her job.48 the woman’s conditions eventually progressed to the point that her doctor placed her on a “no-work-of-anykind restriction.” 49 she was subsequently terminated by her employer on the basis of poor attendance, which led her to file a disability discrimination suit under the ada because her conditions caused her to be substantially limited in the major life activities of performing “manual tasks” and “working” among other things.50 in analyzing the application of the ada to this case, the supreme court further restricted the definition of disability by saying that the terms “substantially” and “major” “need to be interpreted strictly to create a demanding standard for qualifying as disabled . . . .”51 congress recognized that the supreme court’s interpretation of the term disability set the standard for obtaining protection under the ada at a level that was much more strict than originally intended.52 in response, congress enacted the ada amendments act of 2008 in order to reinstate “a broad scope of protection to be available under the ada” and to reject the supreme court’s limitation of the definition of disability as stated in theses 47 id. at 482-83. 48 toyota motor mfg., ky., inc., v. williams, 534 u.s. 184, 187 (2002), superseded by statute as stated in, rohr v. salt river project agric. imp. & power dist., 555 f.3d 850, 853 (9th cir. 2009). 49 id. at 190. 50 id. 51 id. at 197. 52 ada amendments act of 2008, pub. l. no. 110-325, 122 stat. 3553 (2008). 866 indiana health law review vol. 12:2 specific cases. 53 congress kept the original definition of disability in the amended text, 54 but added a nonexhaustive list of major life activities to be protected by the ada including but “not limited to, caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working.”55 a person is considered substantially limited in the performance of a major life activity if the “individual is unable to perform a basic function that the average person in the general population can perform . . . .”56 a person can also be considered substantially limited if he or she “is significantly restricted in the condition, manner, or duration under which [the individual] can perform a particular major life activity as compared to an average person in the general population.”57 the amendments to the ada also specifically provided that the term “substantially limits” should be interpreted consistently with the ada’s purpose to provide broad coverage.58 presumably in direct response to sutton, the ada now states, “the determination of whether an impairment substantially limits a major life activity shall be made without regard to the ameliorative effects of mitigating measures such as (i) medication . . . (ii) use of assistive technology; (iii) reasonable accommodations . . . or (iv) learned behavioral. . .modifications.”59 therefore, the threshold for substantially limits appears relatively easy to meet, and a person may be considered “substantially limited” in a major life activity even if the individual has taken measures to mitigate the effects of the disability. 53 id. 54 42 u.s.c. § 12102 (2015). 55 id. 56 land v. baptist med. center, 164 f.3d 423, 424 (8th cir. 1999). 57 id. at 424-25. 58 42 u.s.c. § 12102(4)(b) (2015). 59 id. § 12102(4)(e)(i)(i)-(iv). 2015 how restaurants discriminate 867 c. restaurants: the missing link the three major subchapters of the ada address discrimination in regards to employment, public services, and public accommodations and services operated by private entities respectively. 60 under the ada, a “restaurant, bar, or other establishment serving food or drink” is considered to be a place of public accommodation as long as the operations of the public accommodation affect commerce. 61 it is extremely difficult for a restaurant to avoid the ada on the basis that it does not affect commerce because congress has the right to regulate interstate and intrastate activities that affect commerce regardless of the entity’s individual impact on interstate commerce, “so long as the entity engages in a class of activities that affects interstate commerce.” 62 the supreme court’s previous recognition that “the restaurant industry unquestionably affects interstate commerce in a substantial way”63 as cited in pinnock v. international house of pancakes franchisee solidifies all restaurants’ classification as a place of public accommodation under the ada. the types of discrimination prohibited by the ada for places of public accommodation are denial of participation, participation in an unequal benefit, and providing a separate benefit to the disabled class.64 one way for places of public accommodation to avoid discriminating against the disabled is to “make reasonable modifications in policies, practices, or procedures, when such modifications are necessary to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities . . . .”65 the place of public accommodation can avoid having to make a reasonable accommodation if 60 americans with disabilities act of 1990, 42 u.s.c. §§ 1210112213 (amended 2008). 61 id. § 12181(7)(b). 62 pinnock v. int’l house of pancakes franchisee, 844 f. supp. 574, 578 (s.d. cal. 1993). 63 id. at 579 (quoting katzenbach v. mcclung, 379 u.s. 294, 303-04 (1964)). 64 42 u.s.c. § 12182(b)(1)(a) (2015). 65 id. § 12182(b)(2)(a)(ii). 868 indiana health law review vol. 12:2 “the entity can demonstrate that making such modifications would fundamentally alter the nature of such goods, services, facilities, privileges, advantages, or accommodations.”66 based on the finding that a restaurant is a place of public accommodation, none of the previously mentioned forms of discrimination can be present in regards to a disabled class. if celiac disease sufferers are recognized as a disabled class, not providing gluten free options would be considered denial of participation and the restaurant would be guilty of discrimination. furthermore, only offering one or two gluten free options on an otherwise expansive menu could also be seen as discrimination by allowing participation but in an unequal benefit. therefore, if celiac disease is classified as a disability under the new, more encompassing standards, it is likely that restaurants will be found to discriminate against them and will be forced to make reasonable accommodations to remedy the discrimination. d. putting it all together the determination that individuals with celiac disease are statutorily disabled is a relatively easy conclusion to draw. celiac disease is an autoimmune disease that prevents individuals from being able to eat wheat, oats, barley, or rye.67 ingesting even trace amounts of these foods can lead to serious, life threatening complications involving the digestive and bowel systems and can also have serious repercussions on an individual’s ability to reproduce.68 the broadening of the definition of disability resulting from the ada amendments act of 2008 includes eating as a major life activity.69 major life activities also include the operation of the major bodily functions of the digestive, bowel, and reproductive functions.70 therefore, 66 id. 67 nat’l digestive diseases, supra note 2. 68 id. 69 42 u.s.c. § 12102(2)(a) (2015). 70 id. § 12102(2)(b). 2015 how restaurants discriminate 869 the complications created by celiac disease affect at least one major life function covered by the ada. the standard for what is considered substantially limited has also been reinterpreted to provide for broad coverage of individuals under the ada.71 the amended ada defines many terms but does not define substantially limited. 72 however, one of the enumerated purposes of the ada amendments act was to reject the demanding strict interpretation requirement of the term “substantially limits” that toyota motor manufacturing, kentucky, inc. v. williams imposed. 73 congress provided guidance for how to interpret substantial limits by including the statement, “the term . . . shall be interpreted consistently with the findings and purposes of the ada amendments act of 2008.”74 the purpose of the ada amendments, to promote broad coverage to individuals, further supports the conclusion that individuals with celiac disease should be considered substantially limited in the major life activities of eating and operation of major bodily functions due to their inability to consume wheat, oats, barley, rye, or their byproducts. moreover, celiac sufferers cannot be excluded from the classification of substantially limited because the condition can be controlled with a gluten free diet. as previously mentioned, the ada amendments act of 2008 specifically provided that an individual who would be considered substantially limited cannot be excluded from that status just because the disease can be controlled through mitigating measures.75 therefore, celiac disease should be defined as a disability under the ada because it is a physical impairment that substantially limits one or more major life activities of an individual. in a recent settlement agreement (discussed 71 id. § 12102(4)(e)(i). 72 see id. 73 ada amendments act of 2008, pub. l. no. 110-325, 122 stat. 3553 (2008). 74 42 u.s.c § 12102(4)(b) (2015). 75 id. § 12102(4)(e)(i). 870 indiana health law review vol. 12:2 below), the doj also reached this conclusion.76 some who opposed the ada amendments act of 2008 because of its inclusiveness agree that celiac disease is considered a disability under the enhanced definition.77 on the other hand, people with gluten sensitivity, as well as most food allergies, would most likely not be considered disabled for the purposes of the ada. for the most part, these individuals do not experience the permanent damage to their body tissue that is caused by autoimmune disorders like celiac disease. the doj has indicated that only those experiencing an autoimmune response to food would be considered substantially limited in the major life activity of eating with the possible inclusion of individuals at risk of anaphylaxis.78 e. conclusion so far, an analysis of the ada, ada amendments act of 2008, and case law has shown that a restaurant is a place of public accommodation, and therefore, governed by the ada. further evaluation of the statutes and the legislative intent along with an in depth exploration of celiac disease has also provided the logical inference that celiac disease is, in fact, a disability warranting protection by the ada. this leaves the extremely difficult question of what restaurants should be required to do in order to provide reasonable accommodations to celiac disease sufferers to avoid discrimination claims under the ada. the following settlement agreement closely parallels this very issue and sheds light on all of the potential modifications faced by restaurants if this becomes widely recognized. 76 questions and answers about the lesley university agreement and potential implications for individuals with food allergies, u.s. dep’t of just. (jan. 2013), http://www.ada.gov/ q&a_lesley_university.htm [hereinafter questions and answers]. 77 paul r. klein, the ada amendments act of 2008: the pendulum swings back, 60 case w. res. l. rev. 467, 485 (2010). 78 questions and answers, supra note 76. 2015 how restaurants discriminate 871 iii. the lesley university settlement: a preview of things to come for restaurants a. the agreement lesley university has approximately 8,000 students and is a private nonprofit university in cambridge, massachusetts.79 lesley university, as many universities do, had a policy that required all students living on campus to participate in and pay for its meal plan.80 the meal plan provided no guarantee that students with celiac disease could eat any of the available options without risk of that food being contaminated.81 in october 2009, a complaint was filed with the doj against lesley university for alleged violations of title iii of the ada.82 this alleged violation of the ada stemmed from the university’s failure “to make necessary reasonable, modifications in policies, practices, and procedures to permit students with celiac disease. . . to fully and equally enjoy the privileges, advantages, and accommodations of its food service and meal plan system.”83 under the ada, any “nursery, elementary, secondary, undergraduate, or postgraduate private school, or other place of education” is considered a place of public accommodation.84 lesley university did not dispute that it met the requirements of a public accommodation under the aforementioned entity classification.85 this section of the ada prohibits “a private university from discriminating against any individual on the basis of disability in the full and equal enjoyment of the university’s goods, services, facilities, privileges, advantages, or accommodations.”86 79 settlement, supra note 1. 80 questions and answers, supra note 76. 81 id. 82 settlement, supra note 1. 83 id. 84 42 u.s.c. § 12181(7)(j) (2015). 85 settlement, supra note 1. 86 id. (citing 42 u.s.c. § 12182 (2015); 28 c.f.r. §§ 36.201, 36.202). 872 indiana health law review vol. 12:2 the settlement agreement (the “agreement”) between the doj and the university does not explicitly state that celiac disease is a disability under the ada.87 the agreement simply states, “[f]ood allergies may constitute a disability under the ada . . . .” 88 the agreement then continues to give the example of celiac disease as an autoimmune disorder that affects the major life activity of eating as well as various bodily functions, but never explicitly states that celiac disease is protected under the ada.89 the doj, however, released a questions and answers report regarding the settlement agreement which concluded that individuals with “autoimmune responses to certain foods” would be included under the definition of disability as it pertains to the ada thereby clearly recognizing the protected status of celiac disease under the ada.90 lesley university recognized that as a public accommodation it must make the “reasonable modifications” to its meal plan policies that “are necessary to afford goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities.” 91 after the university acknowledged that it was a public accommodation and the doj recognized celiac disease as a disability under the ada, “[t]he parties agree[d] that it is in the parties’ best interests . . . to resolve this dispute amicably and without litigation.” 92 the agreement also very explicitly laid out that the agreement was “voluntarily entered into” and that no part of the agreement should be interpreted as lesley university admitting to violating the ada. 93 however, it seems highly unlikely that the university would go out of its way to implement the numerous changes to its food services and bear the 87 see id. 88 id. 89 id. 90 questions and answers, supra note 76. 91 settlement, supra note 1. 92 id. 93 id. 2015 how restaurants discriminate 873 associated cost burdens, discussed below, if it did not believe it was in violation of the ada. to be in compliance with the ada, a public accommodation, such as lesley university, only has to make “reasonable modifications” to its services for those with disabilities if “making such modifications would [not] fundamentally alter the nature of the goods, services, facilities, privileges, advantages, or accommodations” of the entity. 94 the agreement specifically identifies twelve “resolution terms” that the university and the doj agreed upon in order to bring the university’s food services into full compliance with the ada.95 therefore, it follows that all of the agreed upon “resolution terms” were considered “reasonable modifications” to lesley university’s food services. some terms of the agreement require simple procedural changes while others require substantial change to the university’s food services policies.96 the first term of the agreement requires lesley university to formally recognize its status as a public accommodation under title iii of the ada and accept the accompanying obligations. 97 other terms, however, were much more extensive. substantial modifications were mandated for the university’s dining services.98 notices must be posted to inform individuals of all of the potential allergens used in the food preparation area and letting the students know to inform a server of any accommodation needed. 99 lesley university agreed to provide allergen free meals to those individuals requiring a modified meal plan due to allergies that are nutritionally comparable to offerings on the normal meal plan while taking precautionary steps to avoid crosscontamination.100 the university will now provide a preorder option to students with celiac disease that allows 94 id. 95 id. 96 id. 97 id. 98 id. 99 id. 100 id. 874 indiana health law review vol. 12:2 them request their meals as long as they do so 24 hours in advance so the proper ingredients can be obtained.101 all of the meals pre-ordered will be prepared in a dedicated allergen free area of the kitchen of the main dining hall and stored accordingly.102 in order to provide the meals in the most integrated setting possible, pre-ordered meals can be delivered to any lesley university dining hall requested.103 a separate food preparation and storage room containing a refrigerator, freezer, sink, counter area, cabinets, and separate appliances including a microwave and toaster also has to be made available to individuals with celiac disease through key card access.104 individuals with celiac disease must also be allowed to submit “shopping lists” of requested food that the food service provider must stock in the food preparation room at least once per week.105 following suit of the modifications to the dining services, the agreement also mandated educational programs for the kitchen staff.106 food service managers are now required to be trained on how to comply with the terms of the agreement, complete a “servsafe” food handling and food service management course, and meet with a nutritionist annually to discuss the nutritional needs of students with celiac disease. 107 the food service staff of lesley university must be trained on terms of the agreement, must complete training twice per year provided by the food service provider including instruction on celiac disease and how to handle questions regarding it, and also must hold monthly meetings to address allergy awareness.108 possibly the most concerning term of the settlement for places of public accommodation that serve food such as restaurants is that lesley university agreed to pay fifty thousand dollars to the individual that originally filed the complaint with the doj in exchange for the individual 101 id. 102 id. 103 id. 104 id. 105 id. 106 id. 107 id. 108 id. 2015 how restaurants discriminate 875 signing a waiver and release of claims.109 this evidences the potential monetary liability that restaurants could be subjected to as a result of the newly protected status of celiac disease. based on the scope of the terms of the agreement regarding modifications to existing policies, the threshold for what is considered to be a reasonable accommodation is very high. b. applying this analysis to restaurants: cause for concern the 2013 settlement between the doj and lesley university left many wondering about the implications that mandating a food service provider to provide gluten free options would have on the restaurant industry.110 after all, restaurants are a public accommodation just the same as lesley university, which was mandated to provide gluten free options. 111 however, a report released by the doj following the lesley university settlement agreement posed the question, “does the ada require that all public accommodations that serve food, like restaurants, also serve gluten free or allergen-free food?” 112 the answer, quite simply, was “no.” 113 the doj differentiated lesley university’s meal plan from restaurants on the basis that the meal plan was mandatory which required the university to provide “reasonable modifications” to avoid discriminating against students with celiac disease.114 it further stated the obligations for restaurants that serve the public are different. 115 however, the doj does not elaborate on what the obligation of a restaurant is. furthermore, the ada itself does not distinguish between 109 id. 110 mary clare jalonick, food service vulnerable to food allergy lawsuits, usa today, (jan. 18, 2013, 1:10 pm), http://www.usatoday.com/story/news/nation/2013/01/18/food-serviceallergy-lawsuits/1845335/. 111 42 u.s.c. § 12181(7)(b) (2015). 112 questions and answers, supra note 76. 113 id. 114 id. 115 id. 876 indiana health law review vol. 12:2 mandatory and voluntary services offered by places of public accommodation for the purposes of discrimination. therefore, the distinction made by the doj is not supported by the ada, and whether a service is mandatory or voluntary should have no impact on whether or not a place of public accommodation can engage in discrimination. because of the severity of the side effects of ingesting gluten, celiac disease sufferers have to be extremely cautious when choosing a restaurant to dine at.116 in recent years, many restaurants have developed gluten free menus in order to capitalize on the market of the increasing popularity of participating in a gluten free diet. chili’s offers a standard example of the gluten free policy at many restaurants. the restaurant offers a gluten free menu containing a full page of “suggested menu options for wheat/gluten allergies” containing everything from salads to steaks, chicken, and burgers. 117 the extensive menu appears accommodating to celiac disease sufferers, but it includes a disclaimer rendering itself unsafe. 118 the disclaimer states: the following menu options are based on current ingredient information from our suppliers and their stated absence of what and gluten-containing ingredients within these items. please be aware that during normal operations involving shared cooking and preparation areas, including common fryer oil, the possibility exists for food items to come in contact with wheat and gluten-containing ingredients. due to these circumstances, we are unable to guarantee that any menu items 116 nat’l digestive diseases, supra note 2. 117 allergen menu, menu items made without wheat and glutencontaining ingredients, chilis.com, http://www.chilis.com/en/ locationspecificpdf/menupdf/001.005.0000/chilis%20allergen%20ge neric.pdf?aspxautodetectcookiesupport=1 (last visited mar. 22, 2015). 118 id. 2015 how restaurants discriminate 877 can be completely free of allergens or meet gluten-free labeling standards.119 because of this disclaimer, it is extremely dangerous for celiac sufferers to eat at chili’s. disclaimers very similar to this accompany gluten free menus at countless other places such as olive garden and applebee’s.120 the ada’s prohibition against discrimination provides, “no individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation by any person who owns, leases (or leases to), or operates a place of public accommodation.”121 there are two activities considered discriminatory according to the ada that are relevant to this analysis.122 first, the ada prohibits denial of participation, which prevents a disabled individual from being denied the opportunity to “participate in or benefit from the goods, services, facilities, privileges, advantages, or accommodations of an entity” based on the disability. 123 second, the ada also prohibits participation in an unequal benefit, which bans a public accommodation from providing an opportunity to participate in its services if the services are not equally provided to the disabled and non-disabled alike. 124 public accommodations must also offer their services to individuals “in the most integrated setting appropriate to the needs of the individual.”125 based on the previously stated definitions, it is clear that restaurants that do not offer menu items that are guaranteed gluten free are in violation of the ada. 119 id. (emphasis in original). 120 see eat smart, food allergies, olivegarden.com, http://www.olivegarden.com/nutrition#food-allergies (last visited mar. 22, 2015); applebee’s allergen information, applebees.com, http://www.applebees.com/~/media/docs/applebees_allergen_info.pdf (last visited mar. 22, 2015). 121 42 u.s.c. § 12182(a) (2015). 122 see id. § 12182(b)(1)(a). 123 id. § 12182(b)(1)(a)(i). 124 id. § 12182(b)(1)(a)(ii). 125 id. § 12182(b)(1)(b). 878 indiana health law review vol. 12:2 individuals with celiac disease are discriminated against on the basis of their inability to consume even trace amounts of gluten, which is the root cause of their disability. by not providing gluten free options and eliminating the risk of cross-contamination, celiac disease sufferers are not provided with “the full and equal enjoyment of the goods, services, facilities, [and] privileges . . .” that are offered by the restaurant. 126 therefore, restaurants (a public accommodation) are discriminating against celiac disease sufferers (disabled individuals) on the basis of their inability to consume gluten by not providing guaranteed gluten free products, which ultimately denies the individuals the opportunity to “participate in or benefit from the goods, services, facilities, privileges, advantages, or accommodations of an entity.”127 the question now becomes what must be done in order for a restaurant to become compliant with the ada regarding this issue. a restaurant can avoid discrimination by “mak[ing] reasonable modifications in policies, practices, or procedures, when such modifications are necessary to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities, unless the entity can demonstrate that making such modifications would fundamentally alter the nature of such goods, services, facilities, privileges, advantages, or accommodations.”128 guidance for determining what constitutes a reasonable modification comes from beale v. aardvark day care center.129 first, modifications are not required where they would “fundamentally alter” the nature of the public accommodations[’] goods and services. second, modifications are not required if the entity can demonstrate that 126 id. § 12182(a). 127 id. § 12182(b)(1)(a)(i). 128 id. § 12182(b)(2)(a)(ii). 129 beale v. aardvark day care ctr., no. 00-413, 2000 u.s. dist. lexis 19300, at *14 (e.d. pa. dec. 29, 2000). 2015 how restaurants discriminate 879 taking such steps would result in an undue burden. significant difficulty or expense in making an accommodation constitutes an undue burden. third, modifications are not required if doing so would pose a direct threat to the health and safety of others.130 the doj report following the lesley university settlement said restaurants are not required to provide gluten free options as a reasonable modification. 131 the only reasonable modifications required would be for them to answer questions about the ingredients in a menu item if they are known and to substitute or omit ingredients upon request if the restaurant would do it for any patron.132 this seems like a far cry from the “full and equal enjoyment” mandate of the ada, and offers substantially less “protection” to celiac disease sufferers than is offered to other individuals under the statute. iv. disproportionate protection: why the ada as applied by the doj creates a double standard by protecting certain disabilities more than others and what should be done. a. a truly protected disability reasonable modifications for people using wheelchairs or other mobility devices because of qualified disabilities under the ada provides a good example of why restaurants should be required to do more than what is set forth by the doj following the lesley university settlement to accommodate individuals with celiac disease. all public accommodations considered “new construction,” which are constructed for first occupancy after january 26, 1993, are required to be “readily accessible and usable by individuals with disabilities.”133 any alteration to the facilities of a public 130 id. at *15 (internal citations omitted). 131 questions and answers, supra note 76. 132 id. 133 28 c.f.r. § 36.401(a)(1) (2015). 880 indiana health law review vol. 12:2 accommodation made after january 26, 1992, are required to be readily accessible to and usable by individuals with disabilities “to the maximum extent feasible . . . .”134 an alteration is defined as “a change to a place of public accommodation or a commercial facility that affects or could affect the usability of the building or facility or any part thereof.” 135 examples of alterations include, but are not limited to, remodeling, renovation, and rehabilitation. 136 when discussing the definition of “to the maximum extent feasible,” the code of federal regulations implies that it will only be under rare circumstances that a facility will be excused from fully complying with the applicable standards: the phrase “to the maximum extent feasible”. . . applies to the occasional case where the nature of an existing facility makes it virtually impossible to comply fully with applicable accessibility standards through a planned alteration. in these circumstances, the alteration shall provide the maximum physical accessibility feasible. any altered features of the facility that can be made accessible shall be made accessible.137 when making alterations to a facility, the alterations must be fully accessible to disabled individuals so long as the cost of the alterations needed to provide handicapped accessibility does not exceed 20% of the total cost of the project.138 if the 20% limit would be exceeded in providing full accessibility to the altered project, the 20% should first be allocated to providing an accessible entrance, an accessible route, and then to accessible restrooms.139 134 id. § 36.402(a)(1). 135 id. § 36.402(b). 136 id. § 36.402(b)(1). 137 id. § 36.402(c) (emphasis added). 138 id. § 36.403(f)(1). 139 id. § 36.403(g)(2). 2015 how restaurants discriminate 881 the doj created the 2010 ada standards for accessible design that sets out “scoping and technical requirements for accessibility to sites, facilities, buildings, and elements by individuals with disabilities.” 140 these are the specific requirements that have to be met during new construction or alteration of a facility in order to be in compliance with the ada.141 there are specifications touching on everything from amusement park rides to judicial facilities. for purposes of this analysis only specifications pertaining to restaurants will be discussed. first of all, at least one accessible route must be provided from accessible parking spaces and accessible streets and sidewalks, 142 and the accessible ramp cannot have a slope steeper than 1:12.143 if the total number of parking spaces provided by a place of public accommodation is between one and twenty-five, there must be at least one accessible space, and the number increases as the total number of parking spaces increases.144 if bathroom facilities are provided, they have to meet specific accessibility requirements including amount of floor space and door width. 145 where surfaces are provided for dining, at least 5% of the seating spaces must meet accessibility criteria. 146 at least one food service counter has to be accessible in terms of maximum height requirements to accommodate those seated in wheelchairs. 147 all walking surfaces that are part of an accessible route must not have a slope steeper than 1:20 and have to be at least thirty-six inches wide.148 these are a few, but not all, of the requirements that must be met by a restaurant or other place of public accommodation any time 140 2010 ada standards for accessible design, dep’t of just. (sept. 15, 2010) http://www.ada.gov/regs2010/2010adastandards/ 2010adastandards.htm#titleiii [hereinafter ada standards for accessible design]. 141 id. 142 id. 143 id. 144 id. 145 id. 146 id. 147 id. 148 id. 882 indiana health law review vol. 12:2 there is new construction, and they have to be done up to 20% of the total cost of any alteration an existing restaurant undertakes. 149 as for existing places of public accommodation that have not undergone new construction or alteration, title iii of the ada requires them to remove architectural barriers to access when the removal is “readily achievable.”150 readily achievable is defined by the ada as “easily accomplishable and able to be carried out without much difficulty or expense.” 151 whether or not something is considered readily achievable is typically based on cost and other factors of financial means of the facility. 152 legislative history shows that, regardless of cost, congress believed installing ramps, grab bars in restrooms, and rearranging tables was nearly always readily achievable.153 as evidenced by the 2010 ada standards for accessible design, the doj has gone to great lengths to ensure that disabled individuals using mobility devices are able to access the goods and services available by public accommodations such as restaurants. it is not a question of whether or not an accessible feature is reasonable for the facility, but rather how many of them are reasonable and what specifications must be used to make them accessible. the only time a modification is not considered reasonable is if it exceeds 20% of the total cost of the alteration.154 even if the restaurant is not going through new construction or another type of alteration, it is still required to remove any architectural barriers to access that are readily achievable which, at minimum requires an accessible ramp, grab bars in restrooms, and rearranged seating.155 it would be extremely difficult for a restaurant to not be accessible to individuals in wheelchairs and still be in compliance with the ada. 149 see 28 c.f.r. § 36.401 (2015); § 36.402; § 36.403. 150 pinnock v. int’l house of pancakes franchisee, 844 f. supp. 574, 581 (s.d. cal. 1993). 151 id. 152 id. 153 id. 154 28 c.f.r. § 36.403(f)(1) (2015). 155 pinnock, 844 f. supp. at 581. 2015 how restaurants discriminate 883 b. lack of protection for celiac sufferers nowhere in the ada is a distinction made between disabilities for the purpose of protecting one class of disabled individuals more than another. the failure to remove architectural barriers is listed as a type of prohibited discrimination by a place of public accommodation just the same as the failure to make reasonable accommodations.156 however, according to the doj, the only thing restaurants have to do to avoid discriminating against individuals with celiac disease is to answer questions about ingredients in menu items and omit or substitute ingredients from certain items if the restaurant allows all patrons to do so.157 this would be the equivalent of saying that a restaurant is only required to have a wheelchair ramp if it was company policy to do so. the doj justified the enormous difference between the modifications it mandated to lesley university in order to be in compliance with the ada and the simple guidelines for restaurants on the basis that it is not mandatory to eat at restaurants.158 using this logic, restaurants would not be required to conform to the ada at all. it is not likely that it would ever be mandatory for a person using a mobility device to eat at a restaurant, yet the doj mandates rigorous compliance standards that restaurants must abide by in order to accommodate disabled individuals with wheelchairs. in the same way that the ada does not distinguish between the kinds of disabilities by level of importance, it also does not distinguish between mandatory and optional services offered by public accommodations.159 essentially, there is no basis anywhere in the ada for setting the threshold for what is considered a reasonable modification higher than the threshold for any other form of discrimination, such as barriers to access; however, a person in a wheelchair or using another mobility device is much more likely to be provided the goods and services of a 156 42 u.s.c. § 12182(b)(2)(a)(iv) (2015). 157 questions and answers, supra note 76. 158 id. 159 see 42 u.s.c. § 12182 (2015). 884 indiana health law review vol. 12:2 restaurant than an individual that suffers from celiac disease. c. what should be done because of the ada amendments act of 2008’s expansion of the definition of disability, restaurants that do not offer gluten free options discriminate against sufferers of celiac disease by denying them the ability to participate in the goods and services offered by the restaurant based on the individuals inability to consume gluten. 160 this relatively new form of discrimination has been allowed due to the fact that all a restaurant has to do to continue discriminating while remaining compliant with the ada is to comply with the extremely low reasonable modifications standard set forth by the doj following the lesley university settlement.161 in order to combat this continued discrimination the reasonable modification standard for adjusting procedures to provide goods and services to celiac disease sufferers needs to be applied more like the “readily achievable” standard for providing access to restaurants for disabled individuals using wheelchairs and other mobility devices to provide minimum gluten free accommodations at all restaurants. the risks of cross-contamination could be greatly reduced by doing as little as having a dedicated set of gluten free utensils and cookware. 162 this may seem like an unreasonable expense, but the average cost of a wheelchair ramp that congress considers to be readily achievable varies from $80-120 per linear foot. 163 as mentioned previously, the slope of the ramp cannot be more than 1:12, meaning that for every one foot the ramp needs to go up, it must be at least twelve feet long. therefore, a wheelchair ramp that spans a vertical incline of one foot and is twelve 160 see id. 161 questions and answers, supra note 76. 162 see derr, supra note 14. 163 samir shah on mon, practical tips for adding a wheelchair ramp to your home, mda/als newsmagazine (june 3, 2013, 2:15 pm), http://alsn.mda.org/article/practical-tips-adding-wheelchair-rampyour-home. 2015 how restaurants discriminate 885 feet long would cost between $960 and $1,440 according to the cost estimates. this would make a wheelchair ramp far surpass the cost of a set of cookware to dedicate for gluten free food preparation. also, much like rearranging seating to ensure at least 5% of the restaurant is accessible, which is considered readily achievable by the legislature prior to any new construction or alterations, 164 so too should ensuring that 5% of the menu can be made available to accommodate individuals with celiac disease. taking these measures alone would greatly increase the safety of and access to restaurant dining for celiac disease sufferers. furthermore, the same construction standards that are used to mandate accessibility for restaurants should apply to gluten free accommodations. whenever a new restaurant is being constructed, there should be guidelines developed for gluten free preparation areas in kitchens that are set forth in the same way as the accessibility guidelines were laid out in the 2010 ada standards for accessible design.165 also, like the standards for accessible design, any time an existing restaurant undertakes a kitchen alteration the plans should be required to provide for gluten free accommodations to the extent of 20% of the total cost of the alteration. there should also be no distinction between the accommodations considered reasonable for “mandatory” services provided by places like lesley university and “voluntary” services provided by restaurants. the ada does not differentiate between mandatory and voluntary for the purposes of applying the reasonable modifications standard, it only differentiates between the type of entity providing the service.166 all of the relevant mandates of the lesley university settlement agreement should be used as guidelines for the reasonable modification standards of restaurants. 167 this would be a good starting point for implementing standards for restaurants to follow until 164 ada standards for accessible design, supra note 140. 165 id. 166 see 42 u.s.c. § 12182 (2015) 167 settlement, supra note 1. 886 indiana health law review vol. 12:2 further amendments could be made to tailor the requirements more specifically to the restaurant industry. setting a standard for the types of menu items that would be required to prevent a restaurant from discriminating against individuals with celiac disease could prove quite difficult at the beginning. it would admittedly be challenging if there were specific items of food that restaurants were mandated to provide as gluten free options. however, the doj provided a good starting point in the agreement by stating that the gluten free options in the meal plan must be nutritionally comparable to the food offered on the “normal” menu. although this is not a particularly descriptive standard, it gives enough guidance to infer that the gluten free options offered on a restaurant’s menu would have to be similar to the restaurant’s other menu items. for example, an italian restaurant would not be able to offer a garden salad as its only gluten free option. instead, the restaurant would likely be required to develop gluten free pasta dishes that are comparable to those offered on the “normal” menu. regardless of when gluten free options are added to the menu the option should have to be certified gluten free. much like a wheelchair ramp that is too steep, a gluten free menu item that is not certified as gluten free, which most current restaurants do not offer, would be ultimately useless because it would not allow individuals with celiac disease to dine at the restaurant. the ingredients used in meals should have to comply with the new federal drug administration (“fda”) labeling standards for gluten free foods of twenty parts per million (“ppm”) just like the accessibility modifications have to apply to specific standards.168 in order to ensure that the gluten free food is not then made unsafe through cross-contamination, the restaurant’s kitchen should have to be certified by an organization like the national foundation for celiac awareness (“nfca”) or the gluten intolerance group (“gig”). gig offers a program called gluten free food service & management 168 21 c.f.r. § 101.91 (2015). 2015 how restaurants discriminate 887 training (“gffs”) that independently verifies food preparation policies and procedures of restaurants. 169 nfca also offers a training program for food service professionals regarding safe food handling and preparation in order to prevent cross-contamination. 170 having educated employees implementing food preparation procedures created specifically to make food safe for sufferers of celiac disease would provide more gluten free options without a restaurant even changing its menu. for example, the restaurants such as applebee’s that already have gluten free menus but are unable to verify that crosscontamination has not occurred would be able to remove that disclaimer and easily have a menu that would not discriminate against individuals with celiac disease. just when all of this seems like an overly burdensome and nearly impossible feat, an example of a restaurant that has successfully implemented these procedures emerges. california pizza kitchen, inc. (“cpk”) is a pizza chain with more than 200 restaurants. 171 in 2010, the company started making a gluten free pizza crust available at its restaurants, but like many of the restaurants previously discussed, did not ensure the gluten free option was completely gluten free.172 customers immediately began to complain, and the chain pulled the gluten free crust off of its menu.173 cpk then began work with gig to restructure its kitchen operations and train its employees on how to avoid cross-contamination.174 the new procedures that cpk has implemented are very thorough. gluten free pizza crusts arrive at the restaurant 169 get certified, gluten intolerance group, http://www.gffoodservice.org/get-gffs-certified/process/ (last visited aug. 12, 2015). 170 gluten-free certification, nat’l found. for celiac awareness, http://www.celiaccentral.org/gluten-free-certification/ (last updated mar. 23, 2015). 171 julie jargon, at restaurants, gluten-free is a tough recipe, wall st. j. (dec. 15, 2013, 7:37 pm), http://online.wsj.com/ news/articles/sb10001424052702304579404579234201223974792. 172 id. 173 id. 174 id. 888 indiana health law review vol. 12:2 locations in sealed bags and are pre-stretched.175 there are areas designated solely for the preparation of gluten free pizzas.176 cpk separates the ingredients for gluten free and regular pizzas using color-coded bins.177 a manager also supervises the preparation of every gluten free pizza. 178 rice flour, which is gluten free, is used to stretch all normal pizza dough in order to further prevent cross-contamination due to flour particles in the air coming in contact with the gluten free ingredients.179 finally, the pizzas are placed in the oven on disposable aluminum trays so that they do not come into contact with the regular pizza crusts or the surface that the regular pizza crusts are cooked on.180 although this may seem rather intense, cpk said the changes did not cost much. 181 the most significant investment the company found was the time to train employees.182 cpk also charges $2 extra for gluten free pizza crust to help cover the costs of providing the item.183 the company recognizes that the changes were well worth it because of the rapidly growing demand for gluten free food even though sales of gluten free pizzas currently make up less than 5% of cpk’s sales.184 following the lead of cpk, pizza hut has recently announced and implemented a certified gluten free pizza at thousands of its stores across the nation. 185 the gig certified preparation procedures implemented by pizza hut are very similar to those used by cpk.186 the ingredients and utensils are stored in specific gluten free containers, the employee preparing wears gloves, the pizza is put into the 175 id. 176 id. 177 id. 178 id. 179 id. 180 id. 181 id. 182 id. 183 id. 184 id. 185 all of the flavor, hold the gluten, pizzahut.com, https://order.pizzahut.com/glutenfree (last visited mar. 23, 2015). 186 id. 2015 how restaurants discriminate 889 oven on protective parchment paper, and it is even cut with a designated gluten free pizza cutter.187 this is just another example of the feasibility of a national chain becoming gluten free. these companies have provided a model that all other restaurants could follow in order to implement truly gluten free options onto their menus. they have also shown that the modifications necessary to do so are not as costly or burdensome as one may originally think. d. lessons from abroad the united states is not the only country that has seen an increase in the diagnosis of celiac disease in recent years. it is projected that about 1% of the populations of western countries have celiac disease.188 there are varying levels of accommodation for celiac sufferers among these countries. 189 for example, the united kingdom provides individuals diagnosed with celiac disease prescriptions that permit them to buy gluten free food at little or no cost to them because the individuals are reimbursed through their health insurance.190 canada allows for tax deductions of the “incremental cost associated with the purchase of gluten free products, as compared to the costs of comparable nongluten free products.”191 these are all significant policies that undoubtedly ease the burden on celiac sufferers, but one country goes above and beyond in offering extreme protections to those diagnosed with celiac disease. the accommodations offered by italy to individuals with celiac disease are the most significant in the world as well as the most relevant in comparison to the protections that should be offered by the ada. italian celiac sufferers are 187 id. 188 international variations in government policy concerning celiac disease, glutino (aug. 30, 2010), http://www.glutino.com/ourstory/news/variations-in-international-government-policy-concerningceliac-disease/. 189 id. 190 id. 191 id. 890 indiana health law review vol. 12:2 given a stipend of nearly $200 dollars per month to purchase gluten free foods and ease the financial burden that increased prices of gluten free goods can cause.192 not only are they given extra money, but they are also given extra vacation time to account for the added time it can take to shop for and prepare gluten free foods. 193 the most remarkable accommodation offered by the italian government is that the law in italy mandates that gluten free food be available in schools, hospitals, and public places such as restaurants.194 if a country known for its bread and pasta, both traditionally products containing gluten, has been able to offer such effective and progressive accommodations to its celiac population, then the united states should be able to learn from italy’s example and implement similar policies and protections to offer relief to the roughly two million people in the country that struggle with the disease every day. e. solutions for the cost of compliance it is evident that the cost of making alterations to a restaurant kitchen in order for it to be able to produce certified gluten free options could be significant. from a separate set of pots, pans, and utensils to a designated food preparation area, mandating that all restaurants provide gluten free options could prove crippling from a financial standpoint for smaller “mom and pop” restaurants. one way to alleviate this burden would be to amend the internal revenue code (“irc”) to provide tax deductions for the alterations necessary to provide certified gluten free options. section 190 of the irc currently allows any “qualified architectural and transportation barrier removal expenses” up to $15,000 to be classified and written off as an ordinary business expense for tax purposes. 195 192 id. 193 id. 194 celiac policies around the world, celiac disease found., http://celiac.org/celiac-disease/resources/celiac-policies-around-theworld/ (last visited mar. 23, 2015). 195 i.r.c. § 190 (2015). 2015 how restaurants discriminate 891 essentially, this allows a restaurant to deduct any of the expenses it incurs in becoming compliant with the ada’s accessibility standards. if §190 of the irc were to be amended to include any expenses incurred in becoming compliant with title iii of the ada, restaurants would also be able to deduct the expenses incurred in purchasing the new equipment and training necessary to provide certified gluten free options. the $15,000 limitation should also be amended to allow for up to that amount to be deducted for the necessary alterations per restaurant location. it is unlikely that any single restaurant location would have to incur expenses even close to that amount, but it would ensure that all expenses relating to ada compliance efforts by restaurant chains would be covered. therefore, making a slight amendment to the irc would significantly reduce, if not alleviate altogether, the financial burden put on the “mom and pop” restaurants by requiring them to offer certified gluten free menu options in accordance with the ada, and potentially reduce much of the prospective resistance to these mandates. f. crime and punishment in order to encourage restaurants to comply with the new standards, it would likely be necessary for the doj to fine restaurants that do not comply. under title iii of the ada the doj can sue to enforce compliance and obtain civil penalties up to $55,000 for the first violation and as much as $110,000 for any violation after that.196 however, the doj has to go through settlement talks before it can sue a party.197 making it known that lesley university had to pay one individual $50,000 to dismiss a claim as a result of its settlement with the doj would most likely be enough to get most restaurants to comply before complaints against 196 united states department of justice civil rights division, department of justice ada responsibilities: ada enforcement, ada.gov, http://www.ada.gov/enforce_footer.htm (last visited mar. 23, 2015). 197 id. 892 indiana health law review vol. 12:2 them were even filed. the most effective method of enforcement for those that fail to comply with the new standards would be to fine the restaurants on a case-by-case basis to the extent that it does not do irreparable financial damage to the restaurant, but to the point that avoiding the fines becomes a financial incentive to become compliant. v. conclusion the definition of disability has been vastly expanded by the ada amendments act of 2008. individuals that suffer from celiac disease are now considered disabled under the expanded definition. furthermore, restaurants have to adhere to title iii of the ada because they are considered places of public accommodation. however, restaurants discriminate against individuals with celiac disease by not offering certified gluten free menu options because it denies the individuals the ability to participate in the goods and services offered by the restaurant on the basis of their inability to consume gluten. the settlement between the doj and lesley university regarding its meal plan’s lack of accommodations for those students with celiac disease exposed this disparity as well as the liability that could result from an application of the ada to food service providers that fail to provide gluten free food. it has been evidenced in this note that the compliance standards that restaurants are held to in regards to being accessible to the disabled using mobility devices are vastly higher than the compliance standards for restaurants regarding serving individuals with celiac disease. because of this, the actions taken by restaurants in order to avoid officially discriminating against people with celiac disease should be made comparable to the actions that must be taken to be compliant in terms of accessibility. it has been proven by acts of other countries such as italy and restaurants such as california pizza kitchen that it is possible to successfully implement procedures that adequately protect celiac sufferers. the time has come for the government to recognize the rights of individuals with 2015 how restaurants discriminate 893 celiac disease under the ada and to put an end to this expansive discrimination. i. introduction ii. a background of celiac disease and argument for protection a. celiac disease b. the americans with disabilities act c. restaurants: the missing link d. putting it all together e. conclusion iii. the lesley university settlement: a preview of things to come for restaurants a. the agreement b. applying this analysis to restaurants: cause for concern iv. disproportionate protection: why the ada as applied by the doj creates a double standard by protecting certain disabilities more than others and what should be done. a. a truly protected disability b. lack of protection for celiac sufferers c. what should be done d. lessons from abroad e. solutions for the cost of compliance f. crime and punishment v. conclusion state challenges to the patient protection and affordable care act: the case for a new federalist jurisprudence christopher b. serak* i. introduction ....................................................................................... 311 ii. backgroljni)....--legal changes and state challenges ............. 314 a. legal changes in the patient protection and affordable care act ................................................................................................. 314 b. state challenges to the patient protection and affordable care act ........................................................................................ 322 ill. the current state of federalist jurisprudence ..................... 334 a. the anti~commandeering rule ................................................ 335 b. other important concepts to federalist jurisprudence .......... 337 n. a new approach for federalist jurisprudence ...................... .342 a. values of federalism ............................................................... 343 b. an 'expressive' application of the anti-commandeering rule ............................................................................................... 345 v. analysis .............................................................................................. 348 vi. an important counterargument ................................................ 356 vii. summary .......................................................................................... 358 i. introduction the state-initiated challenges to the patient protection and affordable care act1 (the "act") give the courts an important opportunity to recognize state autonomy as an essential aspect of constitutional govemance.2 exist­ ing federalist jurisprudence does not adequately protect the sovereign ca* j.d. candidate, 2012, indiana university robert h. mckinney school of law; m.p.a., 2012, indiana university school of public and environmental affairs-indianapolis; b.s. political science, 2008, wabash college. 1. patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010). 2. see virginia ex rei. cuccinelli v. sebelius, 728 f. supp. 2d 768, 772 (e.d. va. dec. 13, 2010), vacated, 656 f.3d 253 (4th cir. 2011), petition for cert. filed, no. 11-420 (u.s. filed sept. 30, 2011) (addressing congress's power to require the purchase of health insurance under the commerce clause); florida ex rei. bondi v. united states dep't of health & human servs., 780 f. supp. 2d 1256 (n.d. fla. 2011), aff'din part, rev'd in part sub nom., florida ex rei. att'y. gen. v. united states dep't of health & human servs., 648 f.3d 1235 (11th cir. 2011), cert. granted, 132 s. ct. 604 (2011) (determining the individual mandate question, as well as claims against two provisions under the anti-commandeering rule). 312 indiana healm law review [vol. 9:1 pacity of the states to act as legitimate somces of public policy.3 in particu­ lar, the anti-commandeering rule fails to protect the state's regulatory infra­ structure from federal encroachment.4 as a result, there are aspects of the act that appear on their face to violate basic premises of federalism that are unlikely to be remedied by the courts.5 for example, the act establishes a broad regulatory scheme and requires the states to assume administrative · responsibility for the bureaucratic aspects. at the same time, the act trans­ fers regulatory power over health insurance to the federal government, an area traditionally reserved to the states.6 judicial compliance with this scheme can be. corrected by applying a judicial rule that takes an "expres­ sive" approach to defining the limits of state and federal power. an expressive theory of law looks at the social meaning behind gov­ ernment action. 7 it examines how government action communicates values of governance, and how this affects perceptions of the values that underlie the rule of law. current jurisprudence looks for syntactical limits on federal enumerated powers, such as the "economic activity'' threshold of the com­ merce clause.8 this approach reads each structural provision in isolation, effectively defining each clause as self-limiting rather than in symbiotic balance with the remaining document. the problem with this approach is that while deliberately designing a system of vertically divided power with 3. see, e.g., adam b. cox, expressivism in federalism: a new defense of the anti­ commandeering rule?, 33 loy. l.a l. rev. 1309 (2000) (arguing for an expressive ap­ proach to federalist jurisprudence); see also, e.g., printz v. u.s., 521 u.s. 898 (1997) (apply­ ing the anti-commandeering nde in a manner that does not adequately protect state regulatory autonomy from congressional exercises of its plenary powers). 4. see cox, supra note 3, at 1314 (arguing that the ·anti-commandeering rule fails to protect state regulatory autonomy); see also new york v. united states, 505 u.s. 144, 161 (1992) (citing hodel v. virginia swface mining & reclamation assn., inc., 452 u.s. 264, 307 (1981)) (explaining the purpose of the anti-commandeering nde is to protect the states where federal law "commandee[rs] the legislative processes of the states by directly compel­ ling them to enact and enforce a federal regulatory programj. 5. order and memorandum opinion on defendant's motion to dismiss, florida ex rei. mccollum v. united states dep't of health & human servs., 716 f. supp. 2d 1120, 1155 (n.d. fla. 2010) (granting the defendant's motion to dismiss the anti-commandeering claims relating to states' establishment of american health benefit exchanges). 6. hal s. scott, federalism and financial regulation, in federal preemption: states' powers, national interests, 139, 153 (richard epstein & michaels. greve eds., 2007) (explaining that the mccarran-ferguson act gave states autonomy over insurance regulation) (quoting the statute) ("the business of insurance ... shall be subject to the laws of the several states," and "[n]o act of congress shall be construed to invalidate, impair, or supersede any law enacted by any state for the purpose of regulating the business of insur­ ance.") 15 u.s.c. § 1012(a}(b) (2011)). 7. see cox, supra note 3, at 1316 (explaining how government actions are perceived by the public as social messages regarding political truth and the relative power of the gov­ ernment actor). in this note expressivism will be applied in terms of the political values enforced by structural provisions of the constitution, and how these values should be used as a threshold on state and federal power. 8. see, e.g., united states v. lopez, 514 u.s. 549.561-562 (1995), and united states v. morrison, 529 u.s. 598, 610-611 (2000) (analyzing the 'economic' nature of the regulated activity to detennine if it falls within congress's power under the commerce clause). 20 12] challenges to the patient protection and affordable care act 313 expressly limited federal authority, the text of the u.s. constitution says little regarding the regulatory autonomy of the states.9 in fact, without an understanding of the social and political values underlying divided sover­ eignty, and without looking at the constitution's text as a symbiotic whole, the powers enumerated to congress by article 1, section 8 of the constitu­ tion, "fairly admit of a construction that permits the national government to act very nearly as it were a government of general legislative power."10 thus, where the courts view textual provisions regarding state and federal power as solely self-limiting, the states are left largely at the whim of feder­ al authority. modem jurisprudence reflects this concept of broad national power. in fact, the expansion of federal power under the commerce clause led jus­ tice rehnquist to refer to the loth amendment's reservation of broad police powers to the states as "one of the greatest fictions of our federal system."11 while a strong federal government is essential, and it was this need for a general government "adequate to the exigencies of government and the preservation of the union" that led to the adoption ofthe u.s. constitution, federalist jurisprudence must also protect the role of the states.12 for this reason, it is necessary to couple the legal theory underlying the anti­ commandeering rule with an expressive understanding of the constitutional limits of state and federal power. it is the purpose of this note to outline a new judicial approach to the limits of state and federal power that expresses the values that underlie the structural provisions of the constitution. such a rule flows from the idea that ''the nature of a constitutional system imposes on the judiciary an obli­ gation to engage in principled, consistent analysis and to make. decisions that are capable of rational reconciliation with governing textual direc­ tives."13 this rule will be adapted from the anti-commandeering rule. it 9. see, e.g., michael paulsen, debate on the original meaning of the commerce, spending and necessary and proper clauses, in originalism: a quarter century of debate, 253 (steven g. calabresi ed., 2007) (arguing that a textual reading of the constitu­ tion does not explicitly protect "federalism" as a requisite structural aspect of political or­ der). 10. /d. at 254 (arguing that the power to tax, spend, regulate commerce, wage war and displace state regulation expressly enumerated to congress by article 1, section 8 of the constitution necessarily suggests broad national powers). 11. hodel v. virginia surface mining & reclamation assn., inc., 452 u.s. 264, 307 (1981) (rehnquist, j., concurring). 12. the federalist no. 40 (james madison) (arguing that the need for a stronger federal government was the underlying reason for the disposal of the articles of confedera­ tion and ratification of the federalist constitution and explaining further that the states re­ mained in their sovereign capacity, limited only by the powers specifically enumerated to congress). 13. martin h. redish, the constitution as political structure, 9-10 (oxford university press 1995); see also charlton c. copeland, federal law in state court: judicial federalism through a relational lens, 19 wm. & mary bill rts. j. 511, 512 (2011) (ex­ plaining that "[r]elational federalism enforcement is grounded in the recognition that the 314 indiana health law review [vol. 9:1 will examine state and federal action for how it impacts the government's ability to realize the values that underlie the federal system designed by the u.s. constitution. it will in turn be applied to the provisions of the patient protection and affordable care act to demonstrate its prima facie viola­ tions of these values. federal regulation of health insurance as a general matter is not the issue of this critique. federal reform of health insurance can be done constitutionally and may be an appropriate way to approach existing problems. rather, this note will demonstrate why the particular tact ofthe act's regulatory scheme, the use of state governments as admin­ istrative bodies, does not fit within the political structure laid out in the constitution. if nothing else, this note will bring to light how existing su­ preme court jurisprudence ignores fundamental mandates in the constitu­ tion's structuring of political power, in favor of judging congressional action through a tailored, self-contained reading of article i, section 8. the expressive approach advocated here is just one way to correct this dis­ crepancy, and the state challenges to the patient protection and affordable care act are only one embodiment of this jurisprudential failure. before the recommended rule can be developed and applied to the act, it is necessary to examine the provisions of the act and the state­ initiated claims to enjoin their enforcement. it is also essential to review current understandings of state and federal power, and the inadequacy of the anti-commandeering rule to protect state autonomy in this jurisprudential context. next, it is necessary to outline the values that manifest from a well-enforced federalist system. this section will explore the purposes be­ hind the nation's governing architecture in terms of the values it conveys. these values will in turn be used to construct the anti-commandeering rule in a manner that protects state regulatory autonomy and in turn the consti­ tutional rule oflaw.14 finally, this rule will be applied to the patient protec­ tion and affordable care act to show both its benefits to and inherent violations of constitutional federalism ll. background-legal changes and state challenges a. legal changes in the patient protection and affordable care act the most controversial provision of the patient protection and afford­ able care act requires that all citizens acquire a qualified health insurance constitution establishes an enduring relationship between states and the national govern­ ment," and arguing.that government activity should be adjudged for how it complies with ''behavioral norms ... that are consistent with the enduring nature of their interaction [be­ tween the national government and the state governments] under the constitutional structure of federalism."). 14. see cox, supra note 3, at 1348 (arguing that anti-commandeering cases do "not rely explicitly on expressive harms" when invalidating intrusive federal legislation, and therefore fail to protect state autonomy). 20 12] challenges to the patient protection and affordable care act 315 policy or pay a fine. 15 this provision is referred to in the act as the essen­ tial coverage requirement, and informally as ''the individual mandate." congress argues that the individual mandate is within its enumerated power "to regulate commerce with foreign nations, and among the several states, and with the indian tribes.''16 the commerce clause, however, has never been interpreted ''to include the regulation of a person's decision not to pur­ chase a product, notwithstanding its effect on interstate commerce."17 however, the district court in the florida proceedings notes that while this exercise of power may be unprecedented, it is not necessarily unconstitu­ tional. 18 if the individual mandate is upheld by the supreme court, its en­ forcement will serve to expand the scope of congress's sovereign authority and retract that of the states. translated into judicial precedent, this out­ come is in itself a change of law. in this way, the enforcement of the indi­ vidual mandate would result in both a new parameter on individual decision-making and a substantive change in constitutional law. the act also contains important changes for the regulation of health insurance. it introduces federal control through the direct regulation of health insurers, the establishment of a regulatory program for the admin­ istration of intrastate insurance markets, and the ubiquitous oversight of the department of health and human services. beginning with the specific regulation of health insurers, the act amends the public health service act to guarantee all americans access to health care by requiring insurers to accept all applicants for coverage.19 in the same set of amendments, the act interdicts insurers from denying coverage to individuals based on a pre­ existing condition or current health status; and also from charging different rates for any reason other than age, the type of plan (individual or group), the rating area, or tobacco use.20 additionally, the act requires the secre­ tary of health and human services ("secretary") to develop an "essential health benefits package" that establishes the minimum set of benefits all health insurance policies must offer?1 it should be noted that these changes 15. patient protection and affordable care act §1501, 42 u.s.c.§ 18091 (2010); florida ex rei. bondi v. united states dep't. of health & human servs., 780 f. supp. 2d 1256 (n.d. fla. 2011) (holding§ 1501 unconstitutional and the remaining provisions invalid as non-severable), a.ff'd in part and rev'd in part, 648 f.3d 1235 (4th cir. 2011) (finding the mandate unconstitutional but reversing finding of non-severability). 16. u.s. const. art. i, § 8, cl. 3. 17. virginia ex. rei. cuccinelli v. sebelius, 702 f. supp. 2d 598,614 (b.d. va. 2010), vacated, no. ll-1057, 11-1058 (4th cir. sept 8, 2011). 18. florida ex. rei. mccollum v. united states dep't. of health & human servs., 780 f. supp. 2d 1256, 1277 (n.d. fla. 2010). · 19. patient protection and affordable care act § 1201, 42 u.s.c. § 300gg-l(a) (2011). 20. /d. patient protection and affordable care act § 1201, 42 u.s.c.s §§ 300gg(ax1), -3(a), -4(a)(l) (2011). 21. patient protection and affordable care act §1302(b), 42 u.s.c. § 18022(b) (2011). 316 indiana health law review [vol. 9:1 in the law are again two-fold: they introduce new rules for society, while broadening the jurisprudential concept of federal sovereignty under the constitution. the direct regulation of minute aspects of insurance law also contradicts the long-standing principle of reverse preemption embodied by the mccarran-ferguson act, which· protects state regulation of the "busi­ ness of insurance" from incidental preemption by broad acts of congress?2 however, some courts have held that the reverse preemptive effect of the mccarran-ferguson act does not apply where the challenged federal law is a deliberate effort by congress to regulate the insurance industry?3 in turn, the mccarran-ferguson act will not likely be used to limit the preemptive effect of the patient protection and affordable care act. as mentioned above, the patient protection and affordable care act makes important changes to the administration of intrastate insurance mar­ kets.24 these changes are most important for the purposes of this note be­ cause they coerce the states to undertake a specific regulatory program in an area traditionally reserved to the police powers of the states.25 since the passage of the mccarran-ferguson act in 1945, states have enjoyed statu­ tory authority over the regulation of the intrastate insurance industry.26 be­ fore this, state sovereignty over insurance regulation was supported by the 1868 supreme court case of paul v. virginia,21 which ruled that issuing an insurance policy is not a commercial transaction, and is therefore reserved to the states' general police power.28 the mccarran-ferguson act was passed following a circuit court decision overruling paul and subjecting 22. mccarran-ferguson act, 15 u.s.c. § 1011 (2011) (limiting the regulation of in­ surance to the states); see also, e.g., u.s. dep't of treasury v. fahe, 598 u.s. 491 (1993) (interpreting mccarran-ferguson's preemptive effect as applicable to federal laws that regu­ late ''the relationship between insurer and insured, the type of policy which [can] be issued, its reliability, interpretation, and enforcement"). 23. see, e.g., pallozi v. allstate life insurance co., 198 f.3d 28 (1999) (refusing to apply the mccarran-ferguson act to invalidate a provision of the americans with disabili­ ties act that limits the undefwriting power of insurance companies in regards to policies drafted for individuals with hiv or aids). 24. see generally patient protection and affordable care act §§ 1311-1313, 13211324, 1331-1334,42 u.s.c. §§ 18031-18033, 18041-18044, 18051-18054 (2011). 25. see scott, supra note 6, at 153 (explaining the history of state autonomy over insurance regulation). 26. see generally mccarran-ferguson act, 15 u.s.c. § 1011 (2011) (limiting the regulation and taxation of the insurance industry to the states). 27. paul v. virginia, 75 u.s. 168 (1868), overruled in part by united states v. south­ eastern underwriters ass'n, 322 u.s. 533, 553 (1944) (ruling that insurance companies operate across state lines and are therefore interstate corporations subject to federal anti-trust laws), superseded by statute as stated in united states dep't of treasury v. fabe, 508 u.s. 491, 507 (1993) (noting that the mccartan-ferguson act not only overruled south-eastern underwriters, but ''transformed the legal landscape" regarding pre-emption). 28. paul v. virginia, 75 u.s. 168, 183 (1868), overruled in part by united states v. south-eastern underwriters ass'n, 508 u.s. 491 (1944), superseded by statute as stated in united states dep't oftreasury v. fabe, 508 u.s. 491 (1993). 20 12] challenges to the patient protection and affordable care act 317 insurers to antitrust laws. 29 as noted above, some courts have refused to extend the statutory exception from preemption provided by the mccarran­ ferguson act to cases where the intent of congress to preempt state regula­ tion of insurance is explicit in the contested federal law .3° the patient pro­ tection and affordable care act, while perhaps within the judicial exception to mccarran-ferguson, will eliminate the states' monopoly over intrastate health insurance transactions and severely limit the areas of insur­ ance regulation over which the states could still possibly enjoy the protec­ tions of mccarran-ferguson. in effect, the patient protection and affordable care act represents a near-total shift in the locus of insurance regulation from the states to the federal government. the act requires that each state establish an "american health benefit exchange" ("exchange") that ''facilitates the purchase of qualified health plans."31 the exchange must be either a nonprofit organization or a gov­ ernment agency established by a state. 32 the exchange must enforce certi­ fication standards and procedures for qualified plans in line with federal direction. plans offered in state exchanges must be "qualified plans," meaning that they must include benefits at least as extensive as the essential health benefits package established by the secretary.33 the states must cover the cost of benefits required for qualified plans that exceed those re­ quired by the essential benefits package. 34 the secretary is required to es­ tablish a standardized format to present the coverage offered by state exchanges to consumers. 35 the states must publish this information and provide additional consumer support through a website dedicated to the ex­ change. the states must also create a phone line for these same purposes. 36 the states must inform applicants to the exchange of their eligibility for medicare and medicaid benefits, and enroll those applicants in such pro­ grams when they are identified as eligible.37 all the while, the act gives 29. scott. supra note 6, at 139 (citing united states v. sou1h-eastem underwriters ass'n, 64 s.ct. 1162 (1944) and congress's subsequent passage of the mccarran-ferguson act to return regulatory sovereignty over insurance providers to the states). 30. see, e.g., lander v. hartford life & annuity ins. co., 251 f.3d. 101, 120 (2d cir. 2001) (holding that the mccarran-ferguson act does not foreclose federal preemption where the intent to preempt state regulation of insurance is explicit in the contested federal legisla­ tion). 31. patient protection and affordable care act§ 1311,42 u.s.c. § 1803l(b)(2011). 32. patient protection and affordable care act§ l31l(d)(l), 42 u.s.c. § 18031(d)(l) (2011). 33. patient protection and affordable care act § 13ll(d)(2)(b), 42 u.s.c. §§ l803l(d)(2)(b)(i), (d){3)(a) (2011). 34. patient protection and affordable care act §1311, 42 u.s.c. § 18031( d)(3 )(b)(ii)(ll) (2011 ). 35. patient protection and affordable care act § 1311(c)(l); 42 u.s.c. § l803l{c)(l)(g) (2011). 36. patient protection and affordable care act §13ll(d)(4)(b), 42 u.s.c. § 18031(d)(4)(b) (2011). 37. patient protection and affordable care act § 1311(d)(4)(f), 42 u.s.c. § 318 indiana health law review [vol. 9:1 the secretary ultimate regulatory priority over these exchanges, requiring her to establish criteria for certified plans (which are also called "qualified" plans) and set standards for the development of state exchanges.38 further, the secretary must review and approve state exchanges each year.39 the comptroller general is further directed to conduct a semi-annual study of competition in the health insurance exchanges, and to submit the study to congress along with recommendations for administrative or legislative changes deemed necessary to increase competition in health insurance ex­ changes.40 no federal funding will be provided to the states in respect to the administration of the exchanges after january 1, 2015.41 the act also requires states to establish a "small business health op­ tions program" in which the state assists small businesses in acquiring health insurance for their employees.42 states in compliance with the feder­ al regulations may apply for a waiver of this and other provisions to take effect in 2017; however, approval of this waiver is contingent on the state offering health coverage at least as extensive as the essential benefits plan, and offered through an exchange.43 further, such coverage must include the type of cost-sharing and premium limits outlined in the act.44 ultimate­ ly, the states may elect not to administer the regulatory scheme established in the act. in such a case, the federal government will assume the "full regulatory burden" of the act, effectively giving the federal government exclusive regulatory autonomy over that intrastate insurance market.45 so even if the states are allowed to opt out, they will nonetheless lose their regulatory autonomy over health insurance, and in turn, serve a diminished 1803l(d)(4)(f) (2011). 38. see generally patient protection and affordable care act § 132l(a), 42 u.s.c. 18041(a) (2011) (requiring the secretary to establish standards for state exchanges); patient protection and affordable care act§ 133l(a), 42 u.s.c. § 18051(a) (2011) (charging the secretary to review state exchanges and set standards), held unconstitutional as not severa­ ble by florida ex ref. bondi v. united states dep't of health & human servs., no. 3:10-cv91-rviemt, 2011 u.s. dist. lexis 22464 (n.d. fla. mar. 3, 2011). 39. patient protection and affordable care act § l33l(f), 42 u.s.c. § 1805l(f) (2011). 40. patient protection and affordable care act § l313(f), 42 u.s.c. § 18033(f) (2011). 41. patient protection and affordable care act § l311(a)(4)(b), 42 u.s.c. § l803l(a)(4)(b) (2011). 42. patient protection and affordable care act § 131l(b)(l)(b), 42 u.s.c. § 1803l(b)(l)(b) (2011). 43. see patient protection and affordable care act § l332(a)(l)-(2), 42 u.s.c. §§ 18052(a)(l)-(2) (2011). 44. patient protection and affordable care act § 1332(b)(l)(b), 42 u.s.c. § l8052(b)(l)(b) (2011), held unconstitutional as not severable by florida ex ret. bondi v. united states dep't. of health & human servs., no. 3:10-cv-91-rv/emt, 2011 u.s. dist. lexis 22464 (n.d. fla. mar. 3, 2011 ). 45. florida ex ret. mccollum v. united states dep't. of health & human servs., 780 f. supp. 2d 1256, 1266 (n.d. fla. 2010) (concluding that the states' commandeering claim related to the health insurance reforms is foreclosed by the fact the states may opt out of their enforcement). 2012] challenges to the patient protection and affordable care act 319 role in the federal system. likewise, even if a state is given a waiver, it must still use its political infrastructure to create state law requiring insur­ ance companies to provide the essential benefits package outlined in the act. additional laws must be passed or other political action taken to set­ up the state exchange. in february 2011, the empowering states to innovate act was intro­ duced in the senate to move up the effective date of state waivers from 2017 to 2014.46 despite the name, it does not provide any additional lati­ tude for state innovation. if passed, it would only mean that states that are given waivers would no longer have to enforce the waived provisions in the time between the act's effective date in 2014 and the waiver's effective date in 2017. the bill has not passed. as of june 2011, the federal government had granted short-term waiv­ ers to the act's minimum coverage limits for 1,433 separate health plans on the grounds that the provision would force the plan's provider to raise pre­ miums or restrict access to benefits.47 september 22, 2011 was the final day for applications to this waiver program. the federal government also grant­ ed a waiver to the state of maine for the provisions requiring insurance pro­ viders to spend at least eighty percent of premium dollars on providing health services.48 maine was granted the waiver on the grounds that this requirement would destabilize its insurance market because the requirement would cause a major provider to leave the state network. 49 the waiver pro­ gram presents its own constitutional problems by compromising the rule of law and encouraging cronyism. the act also requires the states to establish one or more ''reinsurance" entities to collect payments from health insurance providers and third party administrators on behalf of group plans, which the reinsurance entity dis­ tributes to health insurance providers that cover high-risk individuals in the individual market. 50 these entities are intended to stabilize premium prices in insurance markets that will no longer be allowed to exclude high-risk 46. see generally empowering states to innovate act, s. 248, 111 th cong. § 2 (2011). . 47. jason millman, program offering waivers for health benefits is ending, n.y. times, june 17, 2011, at a12. 48. letter from steven b. larson, deputy adm'r & dir., ctr. for consumer info. & ins. oversight, united states dep't of health & human servs., to mila kofinan, superinten­ dent of ins., state of maine bureau of ins., dep't ofprofl & fin. regulation (mar. 8, 2011) (on file with author), available at htlp:/lhealtbreform.kff.orgl-/media/files/khs/ doc:find­ er/mainewaiver.pdf. 49. letter ftom steven b. larson, deputy adm'r & dir., ctr. for consumer info. & ins. oversight, united states dep't of health & human servs., to mila kofinan, superinten­ dent of ins., state ofme. bureau of ins., dep't ofprofl & fin. regulation (mar. 8, 2011) (on file with author), available at htlp:llhealthreform.kff.orgl-/media/files/khs/ doc:find­ er/mainewaiver.pdf; see associated press, maine gets break in federal health care over­ haul, foxnews.com, mar. 9, 2011, politics: state and local. 50. patient protection and affordable care act § 134l(b)(1)(a), 42 u.s.c. § l8061(b)(l)(a) (2011). 320 indiana health law review (vol. 9:1 individuals from affordable health plans.51 it leaves the secretary to devel­ op a plan for this stabilization, and to define which insurers must pay into the reinsurance program and how much. 52 the act also establishes the pre­ existing condition insurance plan.53 under this provision, the secretary must create a high-risk insurance pool program for individuals with pre­ existing conditions, and contract with qualified entities (states and non­ profits) to provide immediate access to health insurance for these individu­ als. 54 a state may submit an application to health and human services ("hhs") for permission to administer the program,55 and an initial alloca­ tion of $5 billion will be made to each participating state to cover related costs.56 all of these changes introduce federal micro-management to intra­ state insurance markets. title ii of the patient protection and affordable care act makes changes to the administration of medicaid and medicare. one of the largest changes is the expansion of medicaid eligibility to all individuals under the age of 65 who are not pregnant and not currently eligible for medicaid or medicare, and whose income does not exceed 133% of the poverty line.57 the federal government is required to fully fund the medical assistance giv­ en to these newly eligible individuals from 2014 through 2016.58 funding for newly eligible individuals is set at 95% for 2017, 94% for 2018, 93% for 2019, and 90% for 2020 and each year after.59 while the newly eligible individuals are nearly completely funded by federal dollars, the act requires states to stop using disproportionate share considerations in distributing payments to hospitals under a state plan. 60 as a result, federal dispropor­ tionate share hospital ("dsh") payments to states are decreased annually at an aggregate rate of $500 million in 2014, $600 million in each of 2015 and 2016, $1.8 billion in 2017, $5 billion in 2018, $5.6 billion in 2019, and $4 billion in 2020.61 these sums will be divided among the states and sub51. !d. (requiring reinsurance entity to collect funds that can be redistributed to pro­ viders that .cover high risk persons, as defined in subsection (b )(2)). 52. patient protection and affordable care act §1341, 42 u.s.c §l806l(bx3) (2011). 53. see generally patient protection and affordable care act§ llol(b)(l), 42 u.s.c. § 1801. 54. patient protection and affordable care act § llol(b)(l), 42 u.s.c. § 1800 (2011). 55. 45 c.p.r.§ 152.6 (2011). 56. 45 c.p.r.§ 152.33 (2011). 57. patient protection and affordable care act § 200l(a), 42 u.s.c. § l396a(a)(loxa)(ixviii) (2011). 58. patient protection and affordable care act § 200l(a)(3), 42 u.s.c. § 1396d(y)(l)(a) (2011). 59. patient protection and affordable care act § 200l(a)(3), 42 u.s.c. § 1396d(y)(lxa)-(e) (2011). 60. patient protection and affordable care act§ 255l(a), 42 u.s.c. § l396r-4(a)(l) (2011). 61. patient protection and affordable care act § 255l(a), 42 u.s.c. § 1396r4(f)(7)(a)(ii)(i)-(vii) (20 11 ). 20 12) challenges to the patient protection and affordable care act 321 tracted from each state's share of federal medical assistance funding.62 jn turn, the increase in federal dollars devoted to fund newly eligible medicaid participants is essentially offset by the decreases in federal distributions under dsh. this means the states will bear new costs under the pp aca, since the increases in federal assistance under the act are offset by corre­ sponding decreases. in other words, the ppaca forces the states to pay for new entitlements created by the federal government and inhibits the ability of states to compensate hospitals with particularly large numbers of indi­ gent patients. while hospitals heavily dependent on medicaid reimburse­ ment will still be repaid for a percentage of their costs related to participating patients, these hospitals will no longer be given the full amount of additional compensation represented by dsh. since medicaid does not fully reimburse a hospital, dsh payments have been a way to mit­ igate the cost of serving medicaid patients. 63 if states do not make up for missing dsh payments, the care offered at public and private hospitals with large numbers of medicaid patients will likely suffer. the federal govern­ ment may counter this assertion by stating that dsh payments are reduced based on the uninsurance rate in the state, and will therefore only affect hospitals in states where most people are paying customers.64 however, this argument fails to account for the fact that many newly insured· individ­ uals will be medicaid recipients. in turn, even ifuninsurance rates are low­ er under the new regulatory regime, hospitals will still only receive partial compensation for a large number of newly insured individuals.· this leaves them in essentially the same position as before, except without the mitigat­ ing factor ofdsh payments. beyond new fiscal rules, the act establishes limits on state flexibility regarding medicaid eligibility standards, payment structure, and state-level administration in general. each of these limits comes in the form of a con­ dition upon the receipt of federal medical assistance funding.65 first, the act requires states to undertake new enrollment procedures, including the use of digital enrollment and a system that can identify and enroll individu­ als eligible for medicaid when they apply for a plan through the state ex­ change.66 as mentioned above, the act also eliminates existing state-by­ state eligibility standards, which often exclude individuals within one hun62. patient protection and affordable care act § 2551(a), 42 u.s.c. § 1396r4(f)(7)(a)(iii) (2011). 63. evelyne p. baumrucker et al., medicaid and chip: changes made by the health care and education reconciliation act o/2010 (hcera, p.l. 111-152) to the p.atient pro­ tection and affordable care act (ppaca, p.l. 111-148), cong. res. serv. (aprill, 2010), available at http://www.ncsl.org1documentslhealtbimachipchgs.pdf. 64. /d. 65. patient protection and affordable care act § 1943, 42 u.s.c. § 13%w-3(a) (2011). 66. patient protection and affordable care act§ 1943(b)(a)(a), 42 u.s.c. § 1396w3(b)(l)(a)(2011). 322 indiana health law review [vol. 9:1 dred percent of the poverty line who are under the age of 65 and not other­ wise eligible for medicaid. the act requires the states to offer medicaid enrollees a benchmark policy, which satisfies the essential benefits package determined by the secretary.67 a standard method for calculating the in­ come of applicants for medicaid called the modified gross income method is also established, further limiting state flexibility to exclude certain indi­ viduals from medicaid.68 the plaintiff states in the florida proceedings ar­ gue in sum that these provisions "infringe on [their] constitutional status as sovereigns, entitled to cooperate with but not to be controlled by the federal government under the medicaid program.'.ti9 while the patient protection and affordable care act contains addi­ tional changes,· those outlined in this section are the most offensive to the values underlying the establishment of a federalist form of government. 70 these changes will be further addressed in the following discussion of the state initiated challenges to the act. b. state challenges to the patient protection and affordable care act multiple challenges to the patientprotection and affordable care act have been brought by states in federal court.71 one challenge was brought by the commonwealth of virginia in the federal court for the state's eastern district.72 a separate joint complaint was filed by twenty states in the northern district of florida. 73 the states initially named as plaintiffs in the 67. see generally patient protection and affordable care act § 1302, 42 u.s.c. § 18022 (2011) (requiring secretary to establish standards for essential benefits plan). 68. patient protection and affordable care act § 2002, 42 u.s.c. § l396a(e)(14) (2011). 69. second amended complaint, 60, florida ex rei. mccollum v. united states dep't. of health & human servs., no. 3:10--cv-91-rviemt, 2010 wl 247074, at *20 (n.d. fla. jan. 18, 2011). 70. see printz v. united states, 521 u.s. 898, 928 (1997) (citing brown v. epa, 521 f.2d 827, 839) {9th cir. 1975) (explaining that "[p]reservation of the states as independent and autonomous political entities is arguably less undennined by requiring them to make policy in certain fields tban .•. by 'reducing them to puppets of a ventriloquist congress'"). the provisions listed in this section make the states into ''puppets" of the federal government by putting them in a position where they must either perform expansive vast reforms of in­ trastate health insurance markets and implement federal regulatory schemes,programmatic undertakings or lose funding for essential public programs and/or their administrative role in the regulation ofhealth insurance. while the states may opt out of the act's administration, the federal government is still acting as puppet master, as it controls the shape of state level public policy one way or the other. 71. see, e.g., virginia ex rei. cuccinelli v. sebelius, 728 f. supp. 2d 768 (b.d. va. 201 0), vacated, 656 f .3d 253 (4th cir. 2011 ), petition for cert. filed, no. 11-420 {u.s. filed sept. 30, 2011 ); florida ex rei. bondi v. united states dep 't of health & human servs., no. 3:10-cv-91-rv/emt, 2011 wl 285683 (n.d. fla. jan. 31, 2011), a.ff'd in part, rev'd in part sub nom. florida ex rei. atty. gen. v. united states dep't of health & human servs., 656 f.3d 253 {4th cir.), cert. granted, 80 u.s.l.w. 3199 {u.s. nov. 14, 2011) (no. 11-398). 72. virginia ex rei. cuccinelli v. sebelius, 728 f. supp. 2d 768 (e.d. va. 2010). 73. amended complaint, florida ex rel mccollum v. united states dep't. of health 2012] challenges to the patient protection and affordable care act 323 florida proceedings were: alabama, alaska, arizona, colorado, florida, georgia, idaho, indiana, louisiana, michigan, mississippi, nebraska, ne­ vada, north dakota, pennsylvania, south carolina, south dakota, texas, utah and washington. since filing, six additional states have joined the florida proceedings-iowa, kansas, maine, ohio, wyoming, and wiscon­ sin.74 the state of oklahoma also filed a claim in the u.s. district court for the eastern district of oklahoma in january of 2011.75 the combined population of the twenty-six states that have filed suit accounts for about fifty-two percent of all u.s. inhabitants.76 both cases have been decided by a federal district and circuit court, and the multi-state case was granted cer­ tiorari by the u.s. supreme court on november 14, 2011. this section will first address the virginia complaint and then move to the multi-state pro­ ceedings. both the district and circuit court decisions will be presented for these cases. the district court's arguments will be presented in the most detail since these holdings address all of the states' arguments, while the circuit courts only reached a narrow part of the dispute. because the okla­ homa challenge does not raise any additional issues, and because its pro­ ceedings are in such a preliminary stage, it will not be addressed in this note. the complaint filed by the commonwealth of virginia challenges on­ ly the individual mandate provisions found in sections 1501 and 5000a of the act. 77 the complaint argues that congress exceeded its authority under the commerce clause by requiring citizens to purchase health care or be fmed. 78 the crux of this position rests on the idea that the commerce clause does not extend to non-economic activity, notwithstanding any ef­ fect on interstate commerce.79 to this end the commonwealth argues that the decision not to purchase health insurance is not an economic activity or & human servs., 780 f. supp. 2d 1256 (n.d. fla. 2011) (no. 3:10-cv-91-rv-emt), 2010 wl2114067. 74. second amended complaint, supra note 69. 75. see complaint for declaratory and injunctive relief, oklahoma ex rei. pruitt v. sebelius, no. 06:2011-cv-00030 (b.d. okla. jan. 21, 2011); see also press release, okla­ homa office of the attorney general, oklahoma attorney general, e. scott pruitt files federal lawsuit against health care act (jan. 21, 2011 ), available at http://www.oag.state. ok.us/oagweb.nsf70/be4ca4e2dd66492e8625781f007 af390!0pendocument. 76. state and county quick facts, u.s. census bureau (last revised nov. 4, 2010, 12:46 edt), http://quickfacts.census.gov/qfdlindex.html (providing population information via an interactive map). 77. see complaint for declaratory and injunctive relief 1 1, virginia ex rei. cucci­ nelli v. sebelius, 728 f. supp. 2d 768 (b.d. va. 2010) (no. 06:11-cv-00030), 2010 wl 1038397 (laying out the commonwealth's challenge to the patient protection and affordable care act §1501, 42 u.s.c. § 18091 (2010)). 78. see id. (citing u.s. v. lopez, 514 u.s. 549 (1995) and united states v. morrison, 329 u.s. 598 (2000)) (explaining that these cases struck down the regulation of non­ economic activity as going beyond the outer limits of the commerce clause). 79. see id. (quoting gonzales v. raicb, 545 u.s. 1, 25 (2005)) (''despite congression­ al findings that [the regulated subject matter] had an adverse impact on interstate commerce, we held the statute [in morrison] unconstitutional because, like the statute in lopez, it did not regulate economic activity."). 324 indiana health law review [vol. 9:1 even a non-economic activity, but rather "entirely passive."80 virginia ar­ gues that the ''regulation of [such] non-economic activity under the com­ merce clause is possible only through the necessary and proper clause."81 however, the necessary and proper clause only supplements the authority of congress when the means implemented to reach the enumerated power are "appropriate," "plainly designed to that end," and "consistent with the letter and spirit of the constitution.',s2 virginia argues that the individual mandate is not consistent with the underlying principles of the constitution because it presumes to give congress power that runs contrary to basic con­ cepts of justice.83 specifically, the commonwealth speculates that con­ gress created the individual mandate as a means to fund comprehensive health reform by "making healthy young adults and other rationally unin­ sured individuals cross-subsidize older and less healthy citizens.''84 the commonwealth argues that this is akin to a policy which takes the property of a and gives it to be b, something that american concepts of justice do not tolerate.85 virginia's complaint also claims that the noncompliance penalty pro­ vision in section 1501 of the act is unconstitutional because it "does not meet the historical criteria for a tax.''86 specifically, the plaintiff argues that to fall under congress's article i, section 8 tax power, the intended "tax" must have the purpose of generating revenue for the support of the govern­ ment, while the clear purpose of the noncompliance penalty provision is to regulate behavior, not create revenue. 87 in response to the commonwealth's complaint, the federal govern80. see id. , 17. 81. see id., 19 (citing gonzales v. raich, 545 u.s. i, 39 (2005) (scalia, j., concur­ ring)). 82. !d. (citing mcculloch v. maryland, 17 u.s. 316,421 (1819)). 83. id. (arguing that "[r]equiring citizen-to-citizen subsidy or redistribution is contrary to the foundational assumptions of the constitutional compact"). 84. see id., 13. 85. see id. , 20 (quoting calder v. bull, 3 u.s. 386, 388 (1798) (plurality opinion) (arguing that "an act of the legislature (for i cannot call it a law) contrary to the great first principles of the social compact, cannot be considered a rightful exercise of legislative au­ thority," and that any policy which takes the property of a and gives it to b does in fact runs contrary to this "great first principle")). 86. virginia ex. rei. cuccinelli v. sebelius, 702 f. supp. 2d 598, 613 (e.d. va. 2010) vacated, 11-1057, 2011 wl 3925617 (4th cir. sept. 8, 2011) (referencing the common­ wealth's definition of a tax). 87. see reply memorandum in support of plaintiff's motion for summary judgment at 8, virginia ex rei. cuccinelli v. sebelius, 702 f. supp. 2d 598 (e.d. va. 2010) (no. 3: iocv188), 2010 wl 3952341 (citing united states v. reorganized cf&i fabricators of utah, inc., 518 u.s. 213 (1996)) (stating that a "tax is an enforced contribution to provide for the support of government"); see also plaintiff's memorandum in support of motion for summary judgment at 20, virginia ex rei. cuccinelli v. sebelius, 702 f. supp. 2d 598 (e.d. va. 2010) (no. 3:10cv188), 2010 wl 3536788 (citing sunshine anthracite coal co. v. ad­ kins, 310 u.s. 381, 393 (1940)) (holding that to pass constitutional muster, a penalty must be used to further a constitutionally enumerated power). 20 12] challenges to the patient protection and affordable care act 325 ment argues that the individual mandate falls within the traditional scope of congress's regulatory powers under the commerce clause.88 the defend­ ant's argument is essentially that "the sum of individual decisions to partic­ ipate or not in the health insurance market has a critical effect on interstate commerce," and in tum draws these decisions within the definition of eco­ nomic activity properly regulated under the commerce clause.89 in support of this position, the government likens the requirement to purchase insur­ ance with its regulation of non-commercial wheat growers in wickard v. filburn.90 additionally, the federal government argues the penalty imposed for failure to meet the individual mandate is within congress's article i, section 8 power to tax and spend.91 the defendant argues that the mandate falls within congress's power to tax as a means to provide for the "general welfare," and can therefore be checked only by the electorate.92 in august of 2010 the district court denied the federal government's motion to dismiss.93 in december the district court granted the common­ wealth of virginia's motion for summary judgment.94 the court prefaced this latter decision by noting "[ d]espite the laudable intentions of congress in enacting a comprehensive and transformative health care regime, the leg­ islative process must still operate within constitutional bounds."95 as it 88. reply memorandum in support of defendant's motion for summary judgment at 11, 15, virginia ex ref. cuccinelle v. sebelius, 702 f. supp. 2d 598 .(e.d. va. 2010) (no. 3:10-cv-00188), 2010 wl 3952346 (claiming that the individual mandate is within con­ gress's commerce clause power because it "regulates conduct with substantial effects on interstate commerce" and arguing, in addition, that the individual mandate is essential to achieve the act's larger reforms, and that the decision in gonzales v. raich supports the idea that "congress has the authority to take those measures that it rationally finds necessary to give effect to its regulation of interstate commerce"). 89. virginia ex rei. cuccinelli v. sebelius, 702 f. supp. 2d 598, 609 (e.d. va. 2010). 90. jd. (citing wickard v. filbum, 317 u.s. 111 (1942)) (holding that while non­ commercial wheat growers are not engaged in interstate commerce, their production effects supply and demand curves ofthe lager market, and in tum congress is justified in regulating their production of wheat). in the present case the government argues that the wickard deci­ sion applies to the individual mandate because by not buying insurance, the uninsured have an impact on the cost of insurance and health care in general. 91. jd. at 612 (outlining the defendant's argument that the penalty is within con­ gress's power to tax and spend because the legitimate exercise of such power depends on the measure being a means to raise revenue and reasonably related to the ultimate end of the associated regulation). 92. memorandum in support of defendant's motion for summary judgment at 40, virginia ex. rei. cuccinelli v. sebelius, 702 f. supp. 2d 598 (e.d. va. 2010) (no. 3:10-cv00188), 2010 wl 3536789 {relying on united states v. k.ahriger, 345 u.s. 22 (1953) (defin­ ing a broad tax power under article 1, section 8 of the u.s. constitution), overroled in part on other grounds by marchetti v. united states, 390 u.s. 39 (1968}), 93. virginia ex re/.cuccinelli v. sebe1ius, 702 f. supp. 2d 598, 612 {e.d. va. 2010) (no. 3:10cv188) (denying the motion on grounds that the plaintiff's complaint "advances a plausible claim with an arguable legal basis"). 94. see generally virginia ex. rei. cuccinelli v. sebelius, 728 f. supp. 2d 768 (e.d. va. 2010). 95. jd. at 779-780 (setting up the discussion of the boundaries of congress's com­ merce clause power). 326 indiana health law review [vol 9:1 relates to this case, these constitutional bounds are the "outer limits" of the commerce clause.96 the court concluded that to pass a constitutional chal­ lenge, the target of the regulation must be economic in nature, it must affect interstate commerce, and it must be an "activity."97 in this context, the court decided that the decision not to enter the health care market is outside the historical scope of the commerce clause.98 the court also concluded that the penalty attached to the mandate is not a tax, but rather a penalty.99 as a penalty not attached to the exercise of an enumerated power, the measure is not constitutional.100 in sum, the court found the individual mandate and corresponding penalty unconstitutional but declined to enforce an injunction against the enactment of the provisions at this time. the united states court of appeals for the fourth circuit reversed the district court's decision for lack of standing.101 the court held that the commonwealth's assertion of standing via the conflict between the federal mandate and the virginia law prohibiting the forced procurement of health insurance is insufficient to establish standing. specifically, the court argues that the conflict of laws does not satisfy the "irreducible constitutional min­ imum of standing" laid out in ltljan v. defenders of wildlife, which re­ quires a plaintiffto demonstrate that: (1) it has suffered an injury in fact; (2) there is a causal relationship between the injury and the conduct complained of; and (3) a favorable ruling will likely redress that injury.102 the circuit court held that virginia suffered no cognizable harm because the individual mandate applies to individual citizens, and places no burden on the com­ monwealth of virginia.103 the court explained that to satisfy the injury in fact prong of the ltljan standard of standing, the commonwealth must "demonstrate that the individual mandate ... 'invades' its 'legally protected 96. /d. at 780-782 (citing limits placed on congress's commerce clause power by three cases: wickard v. filburn, 317 u.s. 111 (1942) (arguing that the regulated activity in this case was within congress's authority under the commerce clause because the activity was the product of a "self-directed affirmative move," which "self-initialed change of posi­ tion voluntarily placed the subject within the stream of interstate commerce"); united states v. morrison, 529 u.s. 598 (2000); united states v. lopez, 514 u.s. 549,561-562 (1995)). 97. cuccinelli, 728 f. supp. 2d at 781 (e.d. va. 2010) (arguing that precedent shows that regulatory authority under the commerce clause must be "triggered by some type of self­ initiated action"). 98. /d. at 782 (concluding that congress can only regulate "self-initiated action," and that the decision not to purchase health insurance is not a self-initiated action). 99. /d. at 786-788 (concluding that the noncompliance penalty is in fact a penalty and not a tax, because it was repeatedly referred to as a penalty during and before the trial, and to be a tax congress must intend it to be revenue raising measure). 100. id. at 788 (e.d. va., 2010) (citing sunshine anthracite coal co. v. adkins, 310 us 381, 393 (1940)). 101. virginia ex rei. cuccinelli v. sebelius, 656 f.3d 253, 270 (4th cir. 2011) (holding that virginia suffered by cognizable harm through the passage of the patient protection and affordable care act). 102. !d. at 268 (citing lujan v. defenders of wildlife, 504 u.s. 555, 560 (1992)). 103. id. 2012] challengestothepatientprotection and affordable care act 327 interest,' in a manner that is both 'concrete and particularized' and 'actual or imminent. "'104 in this regard, the commonwealth asserted that the indi­ vidual mandate interferes with or commandeers its sovereign capacity to enforce duly passed state laws, and thereby imposes a cognizable harm suf­ ficient to establish standing. 105 the circuit court, however, concluded that the virginia law prohibiting forced purchase of health insurance merely attempts to immunize state citizens from federal law, and is not an assertion of sovereign power, as the commonwealth lacks the sovereign capacity to nullify federallaw.106 in this way, the circuit court argues, the enforcement of the virginia law is stifled not by the mandate provision of the patient protection and affordable care act, but by the supremacy clause of the u.s. constitution.107 as argued, the commonwealth's assertion of standing therefore fails because a legitimate exercise of state sovereignty was not hindered by the challenged federal law, as is required to establish standing on the grounds of state sovereignty. since standing was denied, the fourth circuit decision did not reach the constitutionality of the individual man­ date. on this point, and as an important aside before moving on to the mul­ ti-state case, it should be noted that the fourth circuit decision was based solely on the standing arguments related to virginia's challenge to the indi­ vidual mandate. sovereignty standing may exist in regards to a state's chal­ lenge of the medicaid and insurance industry reforms-provisions that virginia did not challenge. in fact, the federal government conceded such standing in the multi­ state case decided by the eleventh circuit and challenged plaintiff states' standing only in regards to the individual mandate.108 like the fourth cir­ cuit, the eleventh circuit saw the standing of the plaintiff states with re­ gards to the individual mandate as problematic.109 however, the eleventh circuit avoided the question by holding that since individual plaintiffs had standing on the matter the law did concern itself with finding additional sources of standing for the plaintiff states.110 substantively, the complaint brought by multiple states in the north­ em district of florida offers some insight into judicial posture regarding the more abstract federalist issues surrounding the patient protection and af­ fordable care act. the complaint alleges six counts, four of which are rel­ evant to this discussion, and only two of which survived the defendant's 104. id 105. id. 106. id. at 270. 107. virginia ex rei. cuccinelli v. sebelius. 656 f.3d 253,270 (4th cir. 2011). 108. florida ex rei. bondi v. united states dep't. of health & human servs., 648 f.3d 1235, 1243 (11th cir. 2011). 109. id. (admitting that "the question of the state plaintiffil' standing to challenge the individual mandate is an interesting and difficult one"). llo. id. 328 indiana healtii law review [vol. 9:1 initial motion to dismiss. 111 two of these counts evoke the anti­ commandeering rule. count one and two claim that the individual mandate found in section 1501 of the act is unconstitutional.112 this count was ul­ timately used to hold the entire statute unconstitutional. 113 the arguments in favor and against this position are essentially the same as those addressed in the virginia proceedings, and therefore they will not be repeated. not­ withstanding the complete invalidation of the act through the non­ severability of the individual mandate, it is still important to review the findings of the court as they relate to the remaining counts. this is because the court did not find those provisions unconstitutional, and in turn did not apply related judicial concepts of federalism in a manner that truly protects state regulatory autonomy. the third count is that the noncompliance penalty attached to the indi­ vidual mandate is unconstitutional.u4 plaintiffs here take a different ap­ proach than was taken in the virginia case. they argue that the penalty used to enforce the individual mandate is a direct tax in violation of con­ gress' taxing powers per article 1, sections 2 and 9 of the constitution. 115 however, the states cover their bases in count one by arguing that the non­ compliance fee is in fact a penalty and therefore unconstitutional because it is intended to generate revenue. 116 the court ultimately dismissed the claim that the penalty is a direct tax and held that it is instead a penalty.117 the next count that is relevant to this discussion is that the act vio­ lates the anti-commandeering rule by taking away state regulatory discre­ tion in the administration of medicaid and forcing new administrative and financial burdens on the states. us the states claim that the regulatory and related financial burdens placed on them by the act violate the 9th and 1oth amendments and the "constitutional principles of federalism and dual sov­ ereignty on which this nation was founded."119 further, the states argue the regulatory obligations violate their sovereignty and right to republican gov­ ernment under article n, section 4 of the constitution (the guaranty clause). 120 lastly, they argue that the choice to either submit to changes in i i 1. see order and memorandum opinion (defendant's motion to dismiss), florida ex rel. mccollum v. united states dep't. of health & human servs., 7i6 f. supp. 2d i 120, ii65 (n.d. fla. 2010). ii2. second amended complaint, supra note 69, at 1!69-78. 113. florida ex rei. bondi v. united states dep't of health & human servs., 780 f. supp. 2d i256, i299-1305 (n.d. fla. 2011). ii4. second amended complaint, supra note 69, at, 79-82. 115. id., 80. 116. id ,73. 117. order and memorandum opinion (defendant's motion to dismiss), florida ex. rei. mccollum v. united states dep't. of health & human servs., 7i6 f. supp. 2d i i20, ii40 (n.d. fla. 2010). ii8. second amended complaint, supra at note 69, at 1!83-86. 119. jd.1j86. 120. id, 83-86. 2012] challenges to the patient protection and affordable care act 329 medicaid or opt out of medicaid and lose related federal funding, meets the threshold described in steward machine co. v. davis, 121 where "congres­ sional pressure turns into impermissible coercion."122 the states frame this option as a hobson's choice, wherein no real choice is given at all.123 the states must either accept the changes to medicaid, or give up federal fund­ ing for a program that serves millions of its needy citizens, and which they cannot sustain financially with the limited revenue sources available to them.124 in its order granting summary judgment, the court ruled that the changes to medicaid were within congress's spending power, and therefore constitutional. 125 the final count discussed in the complaint is the most important for this note, as much for the fact that it did not survive defendant's motion to dismiss as for its substance. the plaintiffs claim that through the regulatory scheme set forth in the act, congress commandeers state regulatory infra­ structure and violates state sovereignty.126 the argument is that the act will "displace state authority over a substantial segment of intrastate insurance regulation . . . that the states have always possessed under the police powers provided in the constitution . . . . ''127 the states rely on the two definitive cases for the anti-commandeering rule, new york v. united states and printz v. united states.128 the states explain that ''the[] supreme court invalidated both [regulatory] schemes [in new york and printz] based on the constitution's federal architecture and the states' role as dual sover­ eigns in that structure."129 plaintiffs asked the court to enjoin the enforce­ ment of the regulatory scheme contained in the act. in its initial decision on defendant's motion to dismiss, the courts dis­ missed all counts but those related to the commerce clause and the com­ mandeering claim related to medicaid reforms. the court's decision to 121. steward machine co. v. davis, 301 u.s. 548 (1937). 122. florida ex rei. mccollum v. united states dep't of health & human servs., 716 f. supp. 2d at 1157 (citing steward machine co. v. davis. 301 us 548, 590 (1937)) (reason­ ing that, notwithstanding the federal government's power to attach conditions on money distributions to the states, some situations may arise where the conditions are not coercion but unlawful compulsion). 123. memorandum in support of plaintiff's motion for summary judgment at 25, flor­ ida ex rei. mccollum v. united states dep't of health & human servs., 716 f. supp. 2d 1256 (n.d. fla 2010) (no. 3:10-cv-91-rviemt), 2010 wl 4564355. 124. id. at 25. 125. florida ex rel. atty. gen. v. united states dep't of health & human servs., 780 f. supp. 2d 1256, 1267-70 (n.d. fla 2011) (sympathizing with, but not holding as disposi­ tive, the burdens placed on states by the medicaid provisions of the act), order clarified, 780 f. supp. 2d 1307 (n.d. fla. 20ll) and aff'd in part, rev'd in part sub nom. florida ex rel. v. united states dep't ofhealth & human services. 648 f.3d 1235 (11th cir. 2011).) 126. see, e.g., second amended complaint, supra note 69, at, 88. 127. /d. , 44. 128. memorandum in support of plaintiff's motion for summary judgment, supra note 123, at21. 129. id at 25. 330 indiana health law review [vol. 9:1 dismiss the commandeering count related to the establishment of american health benefit exchanges is the most important for the purposes of this note. given existing judicial applications of the anti-commandeering rule, it is not surprising that the claim was dismissed. commandeering cases have limited the rule's protection to those cases where congressforces the states to use their legislatures to pass a statutory scheme in an area not pre­ viously regulated by the states.130 that is, commandeering applies only where federal law requires the states to pass a law in an area previously un­ regulated by the states, and in effect controls the manner in which the states regulate their citizens. 131 as applied, the anti-commandeering rule does not protect state law from being preempted by federal legislative schemes that give the states the option to carry out their provisions or allow the federal government to administer them on the states' behalf. 132 this forecloses the states' claim under the act, as it leaves regulation to the federal government should the states opt to decline participation.133 this point of law requires some further elaboration because it raises important issues related to consti­ tutional values of federalism. as application of the anti-commandeering rule demonstrates, duly passed federal law will always preempt state law under the supremacy clause. however, the supremacy clause should not be applied to allow congress to use its spending power to transform the states into bureaucratic vassals of a federal liege. this is especially so in the context of the anti­ commandeering rule, which has the stated purpose of promoting the consti­ tutional rule that the states are not "regional offices nor administrative agencies" of the federal government. 134 this point will be used to criticize existing tenth amendment jurisprudence in the proceeding sections. how130. see, e.g., hodel v. virginia surface mining & reclamation assn., inc., 452 u.s. 264, 288-291 (1981) (denying the plaintiff state's commandeering claim on the grounds that the challenged statute did not force the states to assume its underlying regulatory scheme and concluding further that the 1oth amendment does not protect state laws passed under the general police power from being displaced by federal laws passed under the commerce clause); see also printz v. united states, 521 u.s. 898, 929 (1997) (holding that comman­ deering occurs where the states are forced to adopt a federal policy scheme, but does not occur where congress has simply "imposed preconditions to continued state regulation of an otherwise pre-empted field"). 131. order and memorandum opinion (defendant's motion to dismiss), florida ex ref. mccollum v. united states dep't of health & human servs., 716 f. supp. 2d 1120, 1155-1156 (n.d. fla. 2010) (referencing hodel v. virginia surface mining & reclamation assn., inc., 452 u.s. 264 (1981)) (arguing that commandeering is not applicable to cases where congress preempts state regulation and gives states the option not to participate in the scheme). 132. see hodel, 452 u.s. at 288. 133. order and memorandum opinion (defendant's motion to dismiss), florida ex rei. mccollum v. united states dep't of health and human servs., 716 f. supp. 2d ll20, 1154 (n.d. fla. 2010) (dismissing the commandeering claim related to the american health benefit exchanges). 134. new york v. united states, 505 u.s. 144, 188 (1992). 2012] challenges to tile patient protection and affordable care act 331 ever, the finding of constitutionality as to congress's exercise of its spend­ ing power also raises a potential discrepancy with existing applications of the law. jonathan adler notes that while citizens who purchase insurance from state operated exchanges are given a federal tax credit to help recoup their costs, citizens who purchase insurance from a federally operated ex­ change are not given this credit.135 so where a state opts out of participa­ tion in the act, the federal government will deny its citizens the tax benefits given to similarly situated citizens in states which administer their own ex­ changes. there is no case law that allows the federal government to condi­ tion spending directed at individual citizens on that citizen's state of domicile enforcing a federal regulation. if nothing else, this type of pres­ sure is politically unsavory and offensive to the rule of law. notwithstanding its ultimate invalidation of the act, the district court's decision did very little to expand protections of state regulatory au­ tonomy. if not for the finding of non-severability, only the individual man­ date would have been voided while every provision challenged under the anti-commandeering rule would remain in force. this outcome prohibits a specific exercise of federal power, i.e., a requirement to purchase health insurance, but fails to prevent the federal government from assuming even greater and more constitutionally offensive authority through the act's es­ tablishment of a broad regulatory scheme, and use of state governments as administrative tools. on the issue of the act's overall validity, the district court concluded: if congress intends to implement health care re­ form-and there would appear to be widespread agreement across the political spectrum that reform is needed-it should do a comprehensive examination of the act and make a legislative determination as to which of its hundreds of provisions and sections will work as intended without the individual mandate, and which will not. it is congress that should consider and decide these quintessentially legislative questions, and not the courts. 136 in sum, while the whole act was invalidated by the florida district court, only the individual mandate was found unconstitutional. the court found legal support for the remaining provisions, which were annulled only through the non-severability of the individual mandate. in reaching this 135. jonathan h. adler, cooperation, commandeering, or crowding out?: federal intervention and state choices in health care policy, 20 kan. j.l. & pub. pol'y 199, 214 (2011). 136. florida ex rei. bondi v. united states dep't of health & human servs., 780 f. supp. 2d 1256, 1305 (2011). 332 indiana health law review [vol. 9:1 decision, the district court was bound by precedent. in fact, the court acknowledged and bemoaned its inability to address the threat to federalism posed by congress's coercive use of its enumerated powers, specifically in relation to medicaid reforms. 137 the importance of the non-severability finding by the district court is brought to the forefront by the eleventh circuit court's reversal of this finding, and ultimate holding that the individual mandate is unconstitution­ al, but is severable from the patient protection and affordable care act's remaining provisions, all of which the circuit court found constitutionally valid.138 for example, the circuit court held that the act's medicaid provi­ sions did not exceed congress's article i spending power.139 the court concluded that the constitution allows congress to attach conditions on its distribution of federal funds to the states. 140 while it acknowledged the ex­ istence of a tenth amendment limit on the coercive use of this power, the circuit court concluded that the act's medicaid provisions did not fall be­ yond this federalist limit.141 specifically, the eleventh circuit concluded that the medicaid amendments were not unconstitutional as "unduly coer­ cive," because the medicaid act allowed the federal government to make amendments at the time the states agreed to enter the regulatory partnership, and because no such amendment had ever been found unconstitutional for conditioning federal funding on state compliance, though several past amendments had done exactly that. 142 the circuit court also argued that the medicaid provisions were not coercive because a majority of the funding burden created by the act would be funded by the federal government.143 lastly, the circuit court argued that the medicaid amendments were not co­ ercive because the act gave the states four years' notice of its regulatory changes, which is sufficient time for the states to decide whether or not to continue participation in the medicaid program. 144 in short, the circuit court's remaining arguments in regards to commandeering largely followed the same reasoning employed by the district court in disposing of these claims. the legal theory involved with these claims will be addressed in more detail in the following section. 137. /d. at 1266 (concluding that congress's use of the spending clause to encourage the states to implement the act's changes to medicaid was contrary to traditional views of state and federal power sharing, and would not be tolerated if not supported by existing su­ preme court case law). 138. see generally florida ex rei. bondi v. united states dep't of health & human servs., 648 f.3d 1235 (11th cir. 20 ii). 139. id. at 1267. 140. /d. (justifying the act's conditions on medicaid funding on the grounds that past medicaid reforms also used conditional spending to ensure their implementation). 141. /d. at 1267-1269. 142. /d. at 1267-1268. 143. /d. at 1268. 144. florida ex ret. bondi v. united states dep't of health & human servs., 648 f.3d 1235, 1268 (lith cir. 2011). 2012] challenges to the patient protection and affordable care act 333 returning to the disposition of the individual mandate, the eleventh circuit concluded that the mandate was unconstitutional, but wru severable from the remaining provisions.145 thus, the circuit court found the individ­ ual mandate unenforceable, but left the act's remaining provisions in force. the eleventh circuit cited the supreme court's "well-established" rule for severability that "unless it is evident that the legislature would not have en­ acted those provisions which are within its power, independently of that which is not, the invalid part may be dropped if what is left is fully opera­ tive as law."146 first, the unconstitutional provision should be used to ren­ der the whole law invalid where it is evident that congress would not have adopted the valid provisions of the law independently of adopting the un­ constitutional provision. second, where it is not so evident, a finding of non-severability should only be reached where after removing the unconsti­ tutional provision, the valid provisions are not "fully operative as a law." the circuit court applied the latter rule (the "operative as law" rule) to all but two of the act's remaining provisions. two of the act's industry re­ forms were subjected to the first rule of non-severability, striking down val­ id provisions where it is evident that they would not have been adopted if not for the adoption of the unconstitutional provision. in applying the "ful­ ly operative" rule, the court summarily concluded that the remaining provi­ sions stood alone from the individual mandate and were independently "operative as a law."147 as for two industry reforms-the guaranteed issue requirement and the prohibition on preexisting condition exclusions-the court found the provisions were "independently operative as law," but ques­ tioned whether they would have been adopted absent the individual man­ date.148 the circuit court referenced legislative record in which congress recognized that the individual mandate was essential to the larger industry reforms. 149 the forced purchase of insurance by healthy individuals would help mitigate the cost born by insurers through the act's requirement that they accept all applicants for insurance, and not exclude any applicant based on a pre-existing condition.150 however, the circuit court found that these reforms were not dependent on the individual mandate because no cross145. id. at 1328. 146. /d. at 1321 (quoting alaska airlines v. brock, 480 u.s. 678, 684 (1987) (emphasis added) (highlighting the degree of certainty necessary to find valid provisions of an act non­ severable from an unconstitutional provision). 147. /d. at 1332-1333. 148. id. at 1323. 149. florida ex rei. bondi v. united states dep't of health & human servs., 648 f.3d 1235, 1332 (11th cir. 2011) (citing 42 u.s.c. 1809l(a)(2)(i)) (stating that the individual mandate is "an essential part of [congress's] larger regulation of [the insurance industry], and the absence of the requirement would undercut federal regulation of the health insur­ ance market"). 150. id. at 1317 (citing 42 u.s.c. 1809l(a)(2)(j)) (stating that "the [individual man­ date] is essential to creating effective health insurance markets that do not require underwrit­ ing and eliminate its associated administrative costs"). 334 indiana heal til law review [vol. 9:1 reference to the individual mandate was present in the provisions of the re­ forms, and because congress did not include a non-severability clause re­ quiring the two reforms to be removed if the mandate is found invalid.151 ultimately, the court stated the remedial question on the issue to be whether the intent of congress in passing the patient protection and affordable care act is better furthered by (1) the act enforced with all provisions except the individual mandate, or (2) the act enforced without both the individual mandate and the two industry reforms. 152 the eleventh circuit concluded that the two reforms further the fundamental purpose of the act to make health insurance more accessible and thereby reduce the number of unin­ sured.153 removing these provisions would reintroduce restrictions on ac­ cess to health insurance and therefore reduce the act's impact on increasing access to insurance and reducing the number of uninsured.154 therefore, the court concluded that the individual mandate is severable from all remaining provisions of the patient protection and affordable care act. together, these challenges to the patient protection and affordable care act reflect an effort by the states to assert a strong, viable role within the federalist balance of power. as may already be evident, existing juris• prudence makes this a difficult task. beginning with the anti­ commandeering rule, the following section will outline the current law as it relates to the promotion of state autonomy, and the distribution of power mider the federal constitution. iii. the current state of federalist jurisprudence federalism refers to the constitution's vertical diffusion of power be­ tween the states and the federal government.155 it is embodied in the specif­ ic enumeration of federal power and the reservation of all remaining authority to the states and the people. this structure is essential to constitu­ tional governance. it ensures that no single sovereign can aggregate the necessary power to oppress liberty or deny the people their express right to a republican form of government. as a negative document, the constitution uses the specific enumeration of federal power to confine the federal gov­ ernment's authority to limited circumstances. the states and the people are left with the authority over the remaining regulatory areas. because the states are the closest regulatory sovereign to the people, they must exercise their broad police power in a manner that does not offend the people's polit­ ical preferences. where those preferences are offended, a new state gov­ ernment can be elected, which in turn has the capacity to change policy 151. /d. at 1324. 152. /d. at 1324-1325. 153. /d. 154. id at 1325. 155. see, e.g., gerald g. ashdown, federalism's floor, 80 miss. lj. 69, 70 (2010). 20 12] challenges to the patient pr.otecrion and affordable care act 335 directions.156 the states likewise send representatives to the federal gov­ ernment to create national policy that is in line with state interests. this protects the people of the several states from having their preferences ig­ nored at the federal level, and gives the federal. government an inherent po­ litical link to the states. where issues of national import exist, that no single state can address, the federal government has sovereign capacity to act.157 the federal government also protects the constitutional rights of the people from violation by the states.158 this balance requires strong states with regulatory sovereignty that can be abrogated only where "national exigency'' requires and only in a manner consistent with the text of the constitution and the principles and values which that text is designed to promote. this section will outline how the federalist structure of government is applied under existing jurispru­ dence. it will demonstrate the failure of modern jurisprudence to effectuate the constitutional system of government defined above. a. the anti-commandeering rule the anti-commandeering rule was introduced by new york v. united states.159 however the outer limits of the rule were discussed eleven years prior in hodel v. virginia surface mining & reclamation ass 'n,. inc.160 in hodel, the state challenged a federal law requiring it to enact and administer a regulatory program over the surface coal mining industry.161 the chal­ lenge alleged that the law was outside congress's commerce clause pow­ ers and violated the tenth amendment. the supreme court found no merit in either argument. the court concluded that the law did not exceed con­ gress's commerce clause powers because the record substantiated that lo­ cal surface coal mining activity had an important impact on interstate commerce, and because the law had a rational relationship to the goals congress sought to accomplish.162 as for the tenth amendment, the court concluded: [t]he tenth amendment does not limit congressional 156. see generally id. at 79 (arguing that the purpose of federalism is to protect the state's capacity to respond to local preferences). 157. see, e.g., robert d. cooter and neils. siegal, collective action federalism: a general theory of article 1 section 8, 63 stan. l. rev. 115, 116 (2010) (arguing that feder­ al power should be limited by examining if the regulated issue requires collective action). 158. see, e.g., ashdown, supra note 155, at 83-84. 159. new york v. united states, 505 u.s. 144 (1992). 160. hodel v. virginia surface mining & reclamation ass'n., inc., 452 u.s. 264, 288 (1981) (concluding that commandeering does not apply to federal laws that give the states the option to participate or transfer authority to the federal government). 161. id at288. 162. /dat265. 336 indiana health law review power to preempt or displace state regulation of pri­ vate activities affecting interstate commerce. moreo­ ver, congress doesnot invade areas reserved to the states by the tenth amendment simply because it ex­ ercises its authority under the commerce clause in a manner that displaces the states' exercise of their po­ lice powers. 163 [vol. 9:1 further, the .court found that the states were not forced to regulate, because they were left free to opt out of the regulatory scheme and allow the federal government to assume the regulation for them. as a result, there was no commandeering. 164 · new york v. united states was the first case to expressly outline the anti-commandeering rule.165 the state of new york challenged a federal law that required the state.'s legislature to either pass a law allowing for the establishment of a nuclear waste treatment facility within the state, or take title to any nuclear waste within its borders.166 the court referenced hodel, stating that the anti-commandeering rule applies where the challenged fed­ eral act "commandeers the legislative processes of the states by directly compelling them to enact and enforce a federal regulatory program."167 the court framed this rule as a protection of the "constitution's plan for the al­ location of intergovernmental. authority," inclusive of an understanding that th~ constitution ·gave to the states a degree of sovereignty so that they could not be treated as "regional offices nor administrative agencies" of the feder­ al government.168 the court stated that "while congress has substantial powers to govern the nation directly, including in areas of intimate concern to the states, the constitution has never been understood to confer upon congress the ability to require the states to govern according to congress' instructions."169 the court noted that this rule did not stop congress from pre-empting state law.170 these are the two exceptions to the anti­ col1ull8ndeering rule mentioned in hodel. the next anti-commandeering case was printz v. united states.171 here the court struck down portions of the brady handgun violence pre163. id 164. id. at 288. 165. seegenerallynewyorkv. united states, 505 u.s. 144 (1992). 166. id at 154. 167. id at 176 (citing hodel v. virginia surface mining & reclamation ass'n., inc., 452 u.s. 264, 288 (1981)). 168. id at 147, 188. 169. id at 162. 170. id at 145; see also hodel v. virginia surface mining & reclamation ass'n., inc., 452 u.s. 264, 288-93 (1981) (allowing the preemption of state law by federal law that does not force state regulatory participation). 171. printz v. united states, 521 u.s. 898 (1997). 20 12) challenges to the patient protection and affordable care act 33 7 vention act that required state and local law enforcement officials to con­ duct background checks on prospective handgun buyers.172 the court held that the brady handgun act's requirement that state officials administer background checks violated the constitutional concept of dual sovereignty. on this point, the court concluded that "[t]he power of the federal gov­ ernment would be augmented immeasurably if it were able to impress into its service-and at no cost to itself-the police officers of the 50 states."173 the case of reno v. condon174 refused to apply the anti­ commandeering rule where the challenged federal law set federal require­ ments for existing state regulations. this narrowed commandeering to situ­ ations where the federal law requires the states to undertake new regulatory activities by passing laws or assisting in the administration of federal poli­ cy.175 this case is supported by the earlier case of south carolina v. baker. 176 in sum, the anti-commandeering rule is intended to protect the inten­ tionally federalist balance of powers created by the u.s. constitution. however, these cases show that the anti-commandeering rule applies only where the federal government forces the states to undertake new regulation, but is not applicable where the option is given for the states to submit ad­ ministration of the law to federal control, or where a generally applicable federal law preempts state law in an area of plenary congressional power. further, it does not stop the federal government from treating the states likes bureaucratic agencies of the federal government so long as the states are allowed to either administer the federal program or give up all participa­ tion in the regulatory area. the federal government lacks both the sover­ eign and logistical capacity to implement broad federal programs on the state level without extensive state participation in administrating those pro­ grams. supplementing federal capacity to regulate by using the bureaucrat­ ic infrastructure of the states to implement substantive federal policy defeats the purpose of creating separate regulatory spheres for the state and federal governments, and compromises the political autonomy of the states which is necessary to effectuate the system of government embodied in the consti­ tution. b. other important concepts to federalist jurisprudence a review of federalist jurisprudence serves to show the inadequacy of 172. see generally id. 173. !d. at902. 174. reno v. condon, 528 u.s. 141 (2000). 175. id. at 150-51. 176. see generally south carolina v. baker, 485 u.s. 505,505-506 (1988) (holding that no commandeering occurs where the federal government does not force states to regulate citizens). 338 indiana health law review [vol. 9:1 protections for state autonomy and the judiciary's preference for federal power. in formulating a judicial rule to protect the values of federalism, it is necessary to understand the manner in which power is balanced under existing law. federalism depends as much on having a strong national gov­ ernment as it does on securing the autonomy of the states.177 any rule which serves to promote the values of federalism must take into account the constitutional mechanisms that shape state and federal power, as well as their judicial constructions. this note addresses only the constitutional mechanisms invoked by the patient protection and affordable care act. these include the spending clause doctrine, congress's power to tax, sov­ ereign immunity, the supremacy clause, and the commerce clause. congress's spending clause power is found in article 1, section 8 of the u.s. constitution!78 in this area, congress's practice of conditional spending has the largest impact on the shape federalism. the dole doc­ trine, articulated in south dakota v. dole, 179 lays out the constitutional standard that congress must meet when it conditions the receipt of federal funds on the state's compliance with a national regulatory standard.180 in this case the court upheld the constitutionality of a federal law that made federal highway funding contingent on the states' changing the drinking age to twenty-one years.181 the court reasoned that the power to tax and spend for the general welfare could be used to obtain regulatory objectives not otherwise within congress's plenary powers, but only where four standards are met. these standards are: (1) the spending must be for the general wel­ fare; (2) the conditions attached must be unambiguous, or "cognizant of the consequences of their participation";182 (3) the federal grants must be relat­ ed to the federal interests involved; and (4) the condition attached must not run afoul of any other constitutional provision.183 there is also an auxiliary fifth prong, which is the recognition that "in some circumstances the finan­ cial inducement offered by congress might be so coercive as to pass the point at which 'pressure turns into compulsion. "'184 this prong is used in the florida proceedings to challenge the attachment of federal health ser­ vices funding to the states' implementation of the act's regulatory scheme.185 this claim was not dismissed, but the court noted "the current 177. see, e.g., the federalist no. 40 (james madison) (saul k. padover ed., 1953) (describing the need for a federal government with sufficient general powers to promote the general welfare, balanced with sovereign states). 178. u.s. const. art. i, § 8, cl. 1. 179. south dakota v. dole, 483 u.s. 203 (1987). 180. id. a/207-08. 181. id. at212. 182. quotingpennhurst state sch. & hosp. v. haldennan, 451 u.s. 1, 17 (u.s. 1981). 183. id. at207-08. 184. id at211 (quoting steward machine co. v. davis, 301 u.s. 548,590 (1937)). 185. order and memorandum opinion (defendant's motion to dismiss), florida ex. ret. mccollum v. u.s .dep't of health & human servs., 716 f. supp. 2d 1120, 1157 (n.d. fla. 2010) (3:10-cv-91-rviemt). 2012] challenges to the patient protection and affordable care act 339 status of the law provides very little support for the plaintiffs' coercion the­ ory argument."186 this outcome could be linked to the fact that the court in dole tempered its decision with the declaration that in adjudicating the con­ stitutionality of conditional spending, federal courts should "defer substan­ tially to the judgment of congress."187 congress's power to tax originates in article 1, section 8 of the u.s. constitution, which gives congress the power to lay and collect taxes for the general welfare and common defense.188 a tax under this provision is defmed as "a pecuniary burden laid upon individuals or property for the purpose of supporting government."189 under this provision a tax must be laid for the purposes of supporting government. however, congress may also use the taxing power to enforce an exercise of an enumerated power by imposing a penalty. 190 the sixteenth amendment gives congress the pow­ er to raise an income tax.191 together, these two provisions give congress a monopoly over government sources of revenue.192 sovereign immunity is embodied in the eleventh amendment, which states that "[t]he judicial power of the united states shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the united states by citizens of another state, or by citizens or subjects of any foreign state."193 the conceptualization of sovereign immunity is complex and exists historically in a variety of permutations.194 in the con­ text of the u.s. constitution the concept is well summed up by the case of seminole tribe of florida v. florida, in which the court stated: ''the elev­ enth amendment presupposes that each state is a sovereign entity in our federal system and that 'it is inherent in the nature of sovereignty not to be amenable to the suit of an individual without a state's consent."'19s this 186. /d. at 1159 (citing nevada v. skinner, 884 f.2d 445, 448 (9th cir.l989)) (explaining if the coercion theory stands at all, it stands on extremely "wobbly legsj. 187. dole, 483 u.s. at 207. 188. u.s. const. art. i, §8, cl. 1. 189. united states v. reorganized cf&i fabricators of utah, inc., 518 u.s. 213,224 (1996) (quoting new jersey v. anderson, 203 u.s. 483, 492 (1906)) (stating the historical definition of a tax.). 190. sunshine anthracite coal co. v. adkins, 310 u.s. 381, 393 (1940) (holding that to pass constitutional muster, a penalty must be used to further a constitutionally enumerated power). 191. see, e.g., lynn a. baker, conditional federal spending qfter lopez, 95 colum. l. rev. 1911, 1936 (1993). 192. see, e.g., id. at 1938. 193. u.s. const. amend. xi. 194. see, e.g., donald l. dorenberg. sovereign imm:unny or the rule of law: the new federalism's choice (2005). 195. see seminole tribe of florida v. florida, 517 u.s. 44, 44 (1996) (quoting puerto rico aqueduct & sewer auth. v. metcalf & eddy, inc., 506 u.s. 139, 146 (1993)) (holding that the eleventh amendment not only protects the states from becoming party to law suits by judicial or congressional coercion, but also serves as "a recognition that the states, alt­ hough a union, maintain certain attributes of sovereignty" within the constitutional system). 340 indiana health law review [vol. 9:1 concept is important because it has been used as a limit on federal power, and as a means to give state autonomy life in the text of the constitution. for instance, the concept of sovereign immunity coupled with the tenth amendment's grant of police powers to the states, is used to give the states nearly complete autonomy over land use regulation and has hindered the passage of a federal land use statute since one was first introduced in 1972.196 this idea has also been used to overturn federal efforts to restrict the use of local land by state agencies. 197 in these situations the court is doing more than invalidating government action because it violates an ex­ press constitutional provision, it is implementing "constitutional values into behavioral norms that impact the nature of national-state interaction."198 in this way, the court recognized that the constitution's federalist structure regulates the interaction of the state and federal governments on expressive grounds. like the eleventh amendment, article v can be construed to convey sovereignty to the states. as states must "consent" to be party to suit under the eleventh amendment, article v requires that two-thirds of the states "consent" to any proposed constitutional amendment.199 giving the states the ultimate check on the enumeration of additional federal power reflects the fact that the states existed before the federal government, and entered into the constitution to transfer to it only those powers they saw necessary for the operation of an effective general government. this perspective is supported by the loth amendment's reservation of all powers not expressly enumerated to the federal government to the states. article v bolsters the validity of this perspective by giving the states ultimate control over the enumeration of new federal powers, which can only be accomplished by constitutional amendment. the federal counterpart to sovereign immunity is found in article vi, clause 2~ and is referred to as the supremacy clause. the supremacy clause invalidates state laws that conflict with legitimate federal laws.200 the practice of invalidating state law through passing conflicting federal law is referred to as preemption, and has become accepted as a sort of un196. john r. nolan, et al., land usb and communtiy development 114 (7th ed. 2004) (explaining also that federal influence over land regulation is still prevalent in the form of conditional spending). 197. solid waste agency ofnorthern cook county v. u.s. army corps ofeng'rs, 531 u.s. 159,.172-174 (2001) (striking down federal efforts to stop the construction ofa landfill by local officials in chicago based on federal concern for migratory birds). 198. copeland, supra note 13, at 549 (interpreting solid waste agency of n. cook co. v. u.s. corps of engineers, 531 u;s. 159 (2001), as limiting federal control of state land use practices on grounds that such 'behavior' violates federalist norms required by structural provisions of the constitution, and not because the activity exceeds federal authority under any one enumerated power). 199. u.s. const. art. v. 200. see u.s. const. art. vi, cl 2. 2012] challenges to the patient protection and affordable care act 341 enumerated federal power?01 to say a state law is preempted means that federal law or regulation has taken away the state or local sovereign's au­ thority to regulate in that area?02 as a general rule, "a federal statute preempts a state law where the latter 'stands as an obstacle to the accom­ plishment and execution of the full purposes and objectives of con­ gress. "'203 this is an extremely important concept in federalist jurisprudence because it gives express sovereignty to the federal govern­ ment in the exercise of its enumerated powers, displacing state law where the sovereigns have concurrent authority. next is the commerce clause. most relevant precedent on this sub­ ject was addressed in the section of this note which outlined the state pro­ ceedings, and therefore the discussion here will be limited~204 the scope of the commerce clause was litigated time and again during the twentieth century, typically ending in an expansion of congressional authority.205 recent cases, however, have begun drawing the outer limits of congres­ sional power under the commerce clause. the case of united states v. lopez outlines three areas that congress may regulate under the commerce clause: (1) the use ofthe channels of interstate commerce; (2) the persons or things in interstate comnierce; and (3) activities that substantially effect interstate commerce.206 the earliest interpretations of congress's com­ merce clause power defined the tenth amendment as stopping the federal government from preempting state regulation undertaken through the gen­ eral police powers?07 however, the court in united states v. darby ex­ pressly rejected the idea that the 1oth amendment places any affirmative 201. see, e.g., cox, supra note 3, at 1344 (arguing that ''tools like preemption and con­ ditional grants are not perceived as expressing disrespect for our federal structure because those tools have a long tradition of established practice," even though they are not expressly enumerated). 202. robert s. peck, a separation-of-powers defense of the "presumption against preemption," 84 tul. l. rev. 1185, 1189 (2010). 203. see, e.g., arizona v. bowsher, 935 f.2d 332, 334 (d.c. cir. 1991) (quoting hines v. davidowitz, 312 u.s. 52,67 (1941)). 204. see supra note 79 (beginning this note's conversation on commerce clause juris­ prudence and citing several landmark cases). 205. see, e.g., wickard v. filburn, 317 u.s. 111, 124 (1942) (granting congress the power under the commerce clause to regulate activities that have a 'substantial effect' on interstate commerce, even if the activity could not otherwise be defined as within the flow of commerce). 206. diane mcgimsey, the commerce clause and federalism qfter lopez and morri­ son: the case for closing the jurisdictional-element loophole, 90 cal. l. rev. 1675, 1702 (2002) (citing united states v. lopez, 514 u.s. 549,575 (1995)). . 207. see, e.g., united states v. e.c. knight co., 156 u.s. 1, 11-13 (1895) (invalidating efforts to regulate intrastate sugar production as a violation of the police powers left to the states and holding that ''the power of a state to protect the lives, health, and property of its citizens, and to preserve good order and the public morals •.. is a power originally and al­ ways belonging to the states, not suitendered by them to the general government, nor direct­ ly restrained by the constitution"). 342 indiana health law review [vol. 9:1 limits on congressional authority.208 n. a new approach for federaust jurisprudence current judicial efforts to protect federalism define specific limits on the enumerated powers of the federal government, but do not consider the values that these limits are intended to promote.209 a court may invalidate an aspect of congressional legislation based on a syntactical threshold of substantive federal power, but in the same case uphold another provision that offends basic principles of federalism because it is within that syntax and because the court does not otherwise see state autonomy as a limit on enumerated powers. for instance, the court in the florida proceedings found the individual mandate to be outside the realm of congressional power under the commerce .clause because the decision not to purchase health insurance is not an "economic activity." at the same time the court flatly rejected the commandeering claims against the medicaid and ameri­ can health benefit exchange provisions because the requirements are with­ in federal authority under existing jurisprudence, and because state regulatory sovereignty is not viewed as an affirmative limit on federal pow­ er.210 this sends the message that while federal power is limited, it is not limited by the need to promote the values of dual sovereignty, but by a tex­ tually contrived limit on commerce clause powers rooted primarily in se­ mantics. at the same time it denies the constitutional value of state regulatory autonomy by allowing the federal government to compel state action or otherwise yield all regulatory relevance. the courts should instead approach conflicts such as this one with a value driven rule. that is, the courts should look at how the contested ac­ tion promotes or hinders the realization of values that underlie the federalist design of the constitution. this rule would better serve to protect the con­ stitution's structural requisites and their underlying purposes, by putting the onus of government action on the manner in which it promotes or hinders these values~ this section will first explore the values of federalism and how they are manifest in constitutional structure. it will then outline the failure of the anti-commandeering rule to promote these values and describe how the rule could be applied more aptly to these ends. 208. h. geoffrey moulton, jr., the quixotic search for a judicially enforceable fed· eralism, 83 minn. l. rev. 849, 855 {1999) (citing united states v. darby, 312 u.s. 100 (1941)). 209. see cox, supra note 3, at 1348. 210. see generally florida a rei. bondi v. united states dep't. of health & human servs., 728 f. supp. 2d 768 (n.d. fl. 2011). 2012] challenges to the patient protection and affordable care act 343 a. values of federalism adam b. cox outlines tbree essential values of federalism: tyranny prevention, experimentation and efficiency, and the enhancement of democ­ racy.211 each value is transcribed through the structural provisions of the constitution, which are built around tbree organizing principles: accounta­ bility, diversification, and checks.212 these principles are achieved through the constitution's provision of dual sovereignty and divided power. if the corresponding structural provisions of the constitution, discussed in the prior sections, are not applied in a manner that embodies these principles, the attached values of federalism cannot be achieved. stated another way, if the states are not treated as regulatory sovereigns, then they cannot fulfill their role in the federal system, and the government cannot deliver the so­ cial and political values inherent to constitutional order.213 the following paragraphs will define each value and outline how its realization depends on the regulatory sovereignty of the states. tyranny prevention refers to ''the fact that the states can serve as and foster political counterweights to the incumbent powers within the federal government.'.214 cox argues that the states can serve this role by offering "organizations that can support generalized opposition to the federal gov­ ernment.'ms further, cox explains that the political institutions of state government serve as an "interest group" on behalf of the citizens. in feder­ alist no. 26, alexander hamilton states, ''the state legislatures . . . will constantly have their attention awake to the conduct of the national rulers, and will be ready enough, if any thing improper appears, to sound the alarm to the people, and not only to be the voice, but, if necessary the arm of their discontent.'.216 without the actual and perceived capacity of the states to serve as a counterbalance to the federal government the states are unlike­ ly to fulfill this role. further, if the citizens of the states do not perceive this capacity they will not see the value in using state political institutions to such ends. in this way, tyranny prevention relies on the states enjoying the degree of sovereignty necessary to effectively check federal authority. experimentation and efficiency refer to the value of having multiple, 211. cox, supra note 3, at 1320-1327; see also, e.g., elizabeth w. leonard, rhetorical federalism: the value of state-based dissent to federal health reform, 39 hofstra l. rev. ill (2011) (arguing that the state initiated challenges are valuable in themselves re­ gardless of their outcome because they bring federalist values and state rights into legal dis­ course). 212. redish, supra note 13, at324. 213. cox, supra note 3, at 1316 ("[t)he states secure certain valu~ of federalism by serving as alternative political institutions to the natiqnal government."). 214. id at 1324. 215. ld. 216. jd. at 1324-25 (quoting the federalist no. 26, at 217 (alexander hamilton) (benjamin fletcher wright ed., 1996). 344 indiana health law review [vol. 9:1 independent regulatory entities and the "economic efficiency [realized] through competition among the states."217 the value of having multiple regulatory entities is in their ability to simultaneously undertake different approaches to the same problems; finding effective policy schemes through trial and error. this process also allows individuals to "vote with their feet." that is, where a state succeeds in crafting favorable policy and anoth­ er state fails, the citizens of the latter state can move to the state with favor­ able policies, and in so doing show their support for one policy approach and their dislike for another. this process depends completely on the regu­ latory autonomy of the states to exercise the broad police powers left to them by the tenth amendment.218 it depends on the court recognizing state autonomy as a limit on federal powers. when federal law is allowed to dictate regulatory details to the states, they are unable to implement crea­ tive policies, or adapt the administration of policy directives to local needs. it also prevents a state from making corrections to problems it observes in regulatory programs. where the states are left in control of the regulatory details, they can respond to observed problems efficiently. this efficiency can foster public appreciation and respect for local government, potentially encouraging civic participation. the ability to respond to such failures with efficiency and speed also enhances democracy, which happens to be the next federalist value addressed in this note. efficiency and experimentation also can refer to the benefit of giving the states the ability to take the lead on issues of concurrent jurisdiction where the federal government has failed. recent budget measures in states like wisconsin and indiana are prime examples. finally, the states enhance democracy through local civic organiza­ tions and other means of democratic participation. they also enhance de­ mocracy by giving local citizens the ability to elect policy-makers that may represent their preferences better than the aggregate national government. in some ways, this enhancement of democracy relates to the value of com­ petition. state citizens can elect new leaders when the policies of the previ­ ous leaders were not successful, and these new leaders can erect policies that better meet these preferences with relative expedience. this federalist benefit is also referred to as the 'fit' "between a givenjurisdiction's policies and the preferences oflocal residents. "219 the federal government does not give this same recourse. this is because if the federal government regulates 217. /d. at 1321; see also, e.g., adler, supra note 135, at 204 (arguing that individual states create better policy through competition than the federal government can by inde­ pendently implementing a single policy choice). 218. see, e.g., id at 1324. the phrase "left to" the states by the tenth amendment, rather than "granted to" the states by the tenth amendment, is important because the consti­ tution does not grant legislative powers the states. the states are the source of the powers distributed by the constitution, and interpreting the constitution to grant substantive powers to the states would be intellectually self-defeating to the underlying concept of government. 219. adler, supra note 135, at 202. 2012] challenges to tile patient protection and affordable care act 345 an activity, and the citizens of some states are satisfied while others are not, only one of these preferences can be manifest in election results, thus leav­ ing one set of citizens happy and the other not. if the states are left free to regulate the area, then a variety of political cultures can be represented in the policies of the several states, allowing individuals to choose the state that best represents their own political values. the enhancement of democracy value depends on the states being given the requisite regulatory autonomy to create diverse policy.220 it also depends on the sovereign most accountable to its constituency holding the most regulatory authority. in other words, it requires the states to hold the most regulatory power over the citizens, as the citizens may more easily influence state policy to meet their interests. similarly, enhanced democra­ cy relates to the states capacity to make large-scale changes quickly as con­ stituents demand, which is only possible through a grant of broad regulatory autonomy. b. an 'expressive 'application of the anti-commandeering rule as applied, the anti-commandeering rule does not adequately promote the values of federalism.221 the decisions in new york and printz leave congress free to impose uniform national regulation by preempting state law, or using a "carrot or stick" approach to coerce states into administering federal regulatory schemes. 222 in turn, federalist values like experimenta­ tion are hampered by the inability of the states to implement their own poli­ cy schemes. they are further damaged by the perception of state political illegitimacy created by federal control of state regulation, and judicial sup­ port for this conduct. adam b. cox explains: "the capacity of a state gov­ ernment to act as a political counterweight to the federal government through intergovernmental checking depends on both national political ac­ tors and state citizens perceiving the state to be a credible political institu­ tion."223 cox further explains that a state's credibility depends on the state being able to maintain legitimately that it represents the interests of its citizens and, as a corollary, to maintain legiti220. !d. at 202-203 (arguing that there is no single answer to health policy issues and the best results come from a decentralized system, in which the states are left to make policy that meets the preferences of their respective citizens). 221. !d. 222. cox, supra note 3, at 1322-23 (referencing new york v. united states, 505 u.s. 144 (1992) (explaining that the anti-commandeering rule does not stop congress from pre­ empting state law, and does not apply where the challenged federal law was of general ap­ plicability); printz v. united states, 521 u.s. 898, 918 (1997) (leaving intact congress's conditional spending power)). 223. cox, supra note 3, 1327. 346 indiana health law review mately that it voice (or threats, as it may be) in the na­ tional political arena is backed by the political force of its citizen-constituents. this requires the state to be able to claim to both national political actors and its own citizens that it represents its citizens' prefer­ ences or best interests.224 [vol. 9:1 it is impossible for the states to be "credible political institutions" ·· when judicial standards leave the federal government to exert control over state regulatory infrastructure and use the threat of monetary drawbacks to force states to undertake the administration of this regulatory scheme. in turn, the anti-commandeering rule should be applied in a manner that articulates the values promoted by the federalist design of the constitu­ tion. this will better gauge the constitutionality of government action than setting thresholds on congress's enumerated powers. specifically, the anti­ commandeering rule should "invalidate congressional legislation that treats the states as puppets."225 that is to say, commandeering should be defined not just as a limit on congress's ability to force states to pass certain laws, but also as a limit on congress's ability to use its enumerated powers to coerce the states into acting as administrators of federal law. this rule would not invalidate generally applicable federal law, administered and en­ forced by the federal government. congress could still directly regulate an industry under the commerce clause, for instance, so long as it did not re­ quire the states to enforce its laws through specific regulatory programs. that is, federal law would still preempt state law under the supremacy clause, but congress could not force the states to implement specific regu­ latory schemes or outlaw similar state programs that are not inconsistent with the new federal law. this would fulfill the value of inter-state compe­ tition by allowing existing state programs to continue, while also promoting the federalist value of a strong general government. congress would be left free to set general regulatory priorities on issues of national import, while the states would be left free to implement those priorities in an efficient manner that best represents the preferences of its constituencies. where deemed appropriate, congress could establish federal programs that redirect federal funding from similar state programs or state adminis­ tered federal programs, so long as they are fully administered by the federal government. where state programs are preempted or otherwise made on­ competitive by the new federal scheme, the states could enter agreements with the federal government to participate in such programs, volunteering a portion of state resources and regulatory infrastructure to gain local admin­ istration of the federal program. congress could not, however, make laws 224. id. at 1327. 225. id. at 1316. 2012] challenges to the patient protection and affordable care act 347 which require states to establish and administer a specific regulatory scheme, and provide that failure to comply with that requirement will result in a loss of federal funding and the assumption of all related regulatory bur­ dens by the federal government. with regards to this restriction on congressional lawmaking, it is im­ portant to note that it is unlikely that the federal government actually has the political or logistical capacity to implement most nation-wide federal programs (e.g., medicaid) without extensive state participation. to com­ pensate for the lack of regulatory capacity, congress often passes laws which require states to administer the resulting regulatory scheme or to lose access to related federal funds and all political relevance in the regulated area. 226 because state governments do not want to deprive constituents of important services offered through state administered federal programs, they accept the funds along with the attached conditions.227 under an ex­ pressive jurisprudence, congress would not be allowed to use its spending power in this way. as discussed above, constitutional governance requires that the states serve as legitimate political counterbalances to the federal government. 228 where the courts allow congress to pass laws that put the states in the position of a bureaucratic agent or unruly dependent, it sends the message that the political structures of state government exist to serve federal priorities.229 further, if congress is prohibited from passing laws which assume and even detail state participation, and use congress's great­ er access to tax revenue as the carrot and stick for state obedience, then congress would have to pass laws which account for the specific regulatory capacity of the federal government, and which are politically popular enough to garner the support of state leaders. in turn, congress would pro­ duce better public policy under an expressive federalist jurisprudence, be­ cause under an expressive theory congress would not pass a law without first considering whether the federal government has the capacity to carry out the resulting regulatory scheme independently, or without otherwise ensuring that the law has sufficient political support to garner voluntary state cooperation. congress would not necessarily sacrifice substantive lawmaking pow­ ers under the expressive reading of the constitution outlined in this note. under an expressive view of federalist jurisprudence congress could pass nearly all the substantive regulations in the patient protection and afforda226. see, e.g .• second amended complaint, supra note 69, at 1 39-41, 68, 73 (outlin­ ing state participation in the medicaid program. and the consequences of the state withdraw­ ing from participation). 227. ld. 168. 228. see, e.g., infra note 201-203 (citing cox, supra note 3, at 1324) (discussing the states' role as counterbalances to the federal government and the need to recognize state sovereignty to empower the states to fill this role). 229. see, e.g., cox, supra note 3, at 1324-1325. 348 indiana health law review [vol. 9:1 ble care act. congress could not, however, use the act to place the states in a subservient position to the federal government, by requiring them to establish and administer a specific regulatory scheme, and to sacrifice criti­ cal federal funding or otherwise implement specific changes to state medi­ caid programs that essentially eliminate the ability of the states to operate the federal program in a manner that accounts for local preferences and in­ dividual circumstances.230 how the expressive· rule specifically applies to the patient protection and affordable care act will be addressed more thoroughly in the following section. v. analysis this section will apply the expressive rule discussed here to different provisions of the patient protection and affordable care act. the out­ comes will demonstrate how expressive principles can be used to draw thresholds on federal power that do not depend on epidemiological inquiry into the precise words of the enumerated power exercised. applying a legal test based on ''values" always runs the risk of political bias. the rule pre­ sented here is strictly based on federalist concepts of state and federal pow­ er underlying the text of the constitution. it uses a holistic reading of that text to draw a picture of the resulting form of government and to decipher the political values enforced by that form of government. the first example will demonstrate how an expressive federalism would not necessarily en­ hance the power of the states, or limit the regulatory sovereignty of con­ gress, but rather· would limit the ability of congress to use its enumerated powers in a way that ignores and detracts from state regulatory autonomy. as will be shown, congress would still have the power to regulate areas it currently regulates, but cotigress could not create policy based on using the states as administrative agents. provisions of the patient protection and affordable care act that in­ troduce direct federal regulation into intrastate insurance industries would be found constitutional under an expressive theory of federalism. contrary to traditional views,231 the federal government has the power to regulate the insurance industry.232 hal s. scott explains that insurance companies are now largely owned and operated by nation-wide financial companies and in 230. see second amended complaint, supra note 69,, 53-60 (outlining the regulatory burdens placed on the states through the act, and explaining bow these burdens, along with the act's medicaid reforms, restrict the states' ability to regulate insurance and administer related health service programs in a manner that accounts for local demographics, and the need for state government to address other priorities). 231. see, e.g., mccarran-ferguson act, 15 u.s.c. § loll (2011) (limiting congress's regulation of the insurance industry by protecting state insurance regulation ftom federal preemption). 232.· see adler, supra note 135, at 207 (arguing that congress has "ample power to regulate health care and health insurance markets''). 2012] challenges to the patillntprotection and .affordable care act 349 tum integrated into an industry currently under the auspices of federal con­ tro1.233 further, current limits on federal regulation of insurance are statuto­ ry, not constitutional, and the mccarran-ferguson act allows federal law to preempt conflicting state insurance law where the federal law "specifically relates to the business of insurance."234 under the mccarran-ferguson re­ gime, insurance transactions have been artificially confined to intrastate markets, as each state was left to create separate rules and regulations gov­ erning the sale of insurance policies. where access to insurance markets is restricted by the multifariousness of state-level regulation, the passage of federal law to remove these barriers to market entry should be deemed an appropriate exercise of congress's preemptive authority under the com­ merce clause. this regulatory authority could be extended to establish the minimum health benefits an insurance policy may offer as a condition on participation in the industry. such regulatory efforts would fit within congress's au­ thority to establish laws necessary and proper for the execution of a plenary power, in this case the regulation of interstate commerce.235 congress's commerce power includes the authority to "facilitate. interstate commerce by eliminating potential obstructions, and to restrict it by eliminating poten­ tial stimulants."236 in this vein, the federal government makes a convincing argument that "decisions about how to pay for health care in the aggregate shift tens of billions of dollars of health care costs each year,, from the unin­ sured, who frequently are unable to pay for the medical services they re­ ceive, onto other participants in the health care market. "237 if insurance companies are forced to sell a minimum set of benefits for a reasonable rate it would encourage participation in insurance markets and decrease the number of uninsured. in tum, such rules would be "appropriate" and "plainly adapted" to executing commerce clause power.238 along this same line of reasoning, congress's commerce clause power extends to the act's effort to make insurance markets more accessible by prohibiting in233. scott, supra note 6, at 139. 234. 15 u.s.c. § l012(b) (2011); see, e.g., pallozi v. allstate life ins. co., 198 f3d 28 (1999) (applying 1012(b) to uphold federal regulation of the underwriting practices of insur­ ance companies). 235. see, e.g., gonzales v. raich, 545 u.s. 1, 34 (2005) (arguing that congress may use the necessary and proper clause to regulate non-commercial activities to ensure the success of larger regulatory schemes carried out under the commerce clause). 236. /d. at 35 (citing nlrb v. jones & laughlin steel corp., 301 u.s. 1, 36-37 (1937) (defining two circumstances where regulation of interstate commerce may be necessary and proper)). 237. reply in support of defendant's motion for summary judgment at 7, florida ex rei. mccollum v. u.s. dept't of health & human servs., 780 f. supp. 2d 1256 (n.d. fla. 2011). 238. gonzales v. raich, 545 u.s. l, 60 (2005) (scalia, j., concurring) (stating that an exercise of the necessary and proper clause is valid where "congress [selects a means of regulation] that is 'appropriate' and 'plainly adapted' to executing an enumerated power"). 350 indiana health law review [vol. 9:1 surers from denying coverage or setting premium prices based on an appli­ cant's pre-existing condition. this removes further obstacles from entry into insurance markets. the reforms guarantee that individuals who cannot access coverage under the current system will be able to purchase insurance in every state market at a reasonable price. congress's power to regulate underwriting practices is supported by pallozi v. allstate life insurance co., where the court upheld provisions of the americans with disabilities act that prohibited insurers from denying applicants based on a disabil­ ity_239 these industry regulations promote the federalist value of a strong general government fit to pursue the general welfare of the people. where a problem has national implications which cannot be appropriately resolved by the independent regulatory efforts of the states, the need for a strong na­ tional government is greatest, and federal action is most valuable. health care is an issue that has taken on an ever-greater national dimension. medi­ caid has grown significantly and has an important presence in every state insurance market.240 medicaid funding is shared by every state and of course derived from the taxes paid by the citizens of each state. the more money hospitals lose rendering uncompensated and undercompensated care to the uninsured and indigent, the more health care costs will rise. since health care costs are shared nationally, both through federal insurance pro­ grams and the mj.llti-state operations of insurers, it is reasonable to look for a national solution. the act's industry regulations that are geared toward opening insurance markets are therefore in line with the critical purpose citied by james madison for abandoning the articles of confederation in favor of creating a federal constitution defined by a strong central govern­ ment endowed with powers "adequate to the exigencies of government and the preservation of the union."241 the nature of regulable subject matter within congress's article 1, section 8 powers, is likewise limited to activi­ ties that inherently entail issues of national import, and which cannot be effectively addressed by the legislative efforts of the several states.z42 to conclude, an expressive theory of law would endorse congress's efforts to address the national problems of uninsurance and rising health care costs by using its article 1, section 8 powers to make intrastate insurance markets accessible to all state citizens. however, the resulting laws would have to be administered by the federal government, and would still need the support 239. pallozi v. allstate life ins. co., 198 f3d 28 (2d cir. 1999). 240. see, e.g., second amended complaint, supra note 69, 1f 51 (outlining the effect of the medicaid program on florida's health insurance market and explaining that "even before passage of the act, the medicaid program imposed a heavy cost on florida, consuming 26 percent of its annual budget. for fiscal year 2009-2010 alone, florida [spent] more than $18 billion on medicaid, servicing more than 2. 7 million persons."). 241. federalist no. 40, at 102 (james madison) (saul k. padover ed., 1953). 242. see generally cooter, supra note 157. 2012] challenges tothepatientprotectionandaffordablecareact 351 of the people to remain in force.243 this latter observation will be expanded on later. unlike the act's general regulation of the insurance industry, the indi­ vidual mandate provision would be held invalid under an expressive view of federalism. since the states have sovereign authority over the exercise of all powers not enumerated to the federal government, any expansion of those enumerated powers necessarily means a contraction of state sover­ eignty.244 since the individual mandate exceeds congress's commerce clause power, or at least expands its scope to allow for the regulation of decisions not to enter interstate commerce, its validation would represent an expansion of federal authority.245 by expanding the scope of the commerce clause, the courts would allow congress to regulate any number of activi­ ties or passive decisions so long as they have a substantial impact on na­ tional commerce. allowing congress to regulate beyond the scope of its textual power detracts from the states • ability to check federal power by using the courts to enforce the textual bounds of the constitution. this is offensive to tyranny prevention. it is also offensive to the values of effi­ ciency and experimentation. allowing congress to regulate new types of activities under the commerce clause infringes on the tenth amendment's reservation of state sovereignty over such activities. this means there are fewer circumstances in which the states can adopt independent policy measures, and facilitate competition among these approaches. it also means the states are less able to make policy that meets the preferences of their individual constituents, and the people are in turn less able to affect policy preferences using the state political process. 246 as an alternative to the mandate, congress could establish a single­ payer insurance system in which every individual pays a tax and in turn re­ ceives health benefits from the federal government. since congress can regulate insurance under the commerce clause, and since there is no forced purchase, the single payer system would not violate or expand congress's enumerated powers. the states would not be commandeered to implement individual insurance exchanges, and the people would not be forced to un­ dertake a commercial activity involuntarily (although their choice in regards to the purchase of health insurance would be obliterated). under the tax 243. see generally cox. supra note 3, at 1326 (arguing that federalism prohibits federal law that treats the states as administrative puppets, and argues that where the people perceive their state government as ineffective to protect their political interests, they will participate directly in the political process rather than the state). 244. u.s. const. amend. x. 245. memorandum opinion (cross motions for summary judgment), 728 f. supp. 2d 768, 782 (b.d. va. 2010) (concluding that the decision not to purchase insurance is not a commercial "activity" regulated under existing understandings of the commerce clause). 246. adler, supra note 135, at 202 (arguing that the federal government should not pass legislation that attempts to offer a "single right answer" to a problem that evokes a variety of policy preferences). 352 indiana health law review [vol. 9:1 and spend power, congress could institute a tax on every individual and use it to. fund a federal health plan. in this way, much like social security, hold­ ing a health insurance plan would simply be a product of paying taxes. while this approach appears to be a greater exertion of federal control then the regulatory scheme established by the act, and would not be attractive to an advocate of small government or individual economic freedom, it does not violate the constitution's political order, nor the values underlying a well-enforced federalist government. a federal single payer system would simply replace the act's state-exchange system with a single federal ex­ change, which would assume the full administrative burden for distributing government insurance policies. this would fulfill the value of a strong general government, capable of instituting unitary solutions to national problems. while it would contradict the value of experimentation, it would further the value of efficiency, as in instances of national necessity a single policy answer is preferable to multiple state approaches. this conclusion is not an endorsement of a single-payer system. con­ gress could create such a regulatory regime, but will only do so if it has the political capital to do so. herein lies one of the most important checks on the federal government-the political process. elections give the people the ultimate check on congress's ability, and willingness, to regulate. state sovereignty only prevents the federal government from exceeding its plena­ ry powers, and cannot check independent federal regulation of activities within those plenary powers. it is ultimately up to the people to use the po­ litical process to decide which activities the federal government will regu­ late with its enumerated powers. it is that much more important, therefore, that the courts enforce state sovereignty and restrict the manner in which the federal government regulates. otherwise the people's check on the activi­ ties regulated by congress will not be reinforced by constitutional limits on congress's regulatory authority. the act's requirement that states establish an american health bene­ fit exchange would be invalidated under a value-centered theory of federal­ ism. this requirement damages the political legitimacy of the states and treats them as "puppets."247 further, it hinders the value of competition by dictating to the states how to regulate intrastate insurance transactions. dic­ tating regulatory process also limits the states' ability to respond to the preferences of their constituents. where congress at once preempts state regulation and simultaneously requires the states to enforce the correspond­ ing reforms, congress furthers the value of having strong central govern­ ment, but violates the constitutional autonomy of the states. the act does offer the opportunity for the states to apply for a waiver of its provisions?48 247. see cox, supra note 3, at 1330-31; see also new york v. united states, 505 us 144, 188 (1992). 248. patient protection and affordable care act§ 1332, 42 u.s.c § 18052 (2011 ). 2012) challenges to the patient protection and affordable care act 353 however, the waiver requires that the state regulatory plan include the es­ tablishment of an exchange under the definition of the act.249 it requires coverage offered through such an exchange to meet the requirements of the essential benefits package.250 the waiver provisions do not allow the states to retain regulatory autonomy. ultimately, the states may opt out of the exchange requirement and allow the federal government to assume the act's full regulatory burden on the state's behalf.251 congress probably assumes that this option will scarcely be exercised. if every state opted out of participation and instead left the act's full regulatory burden to the fed­ eral government, it is unlikely the act's provisions could ever be fully im­ plemented.252 the exchange provision is also important for its expressive implica­ tions on federalism. by allowing congress to treat the states as "adminis­ trative agencies" of the federal government, the court sends the message that the states are not counterbalances, nor political alternatives to the fed­ eral goveriunent, but rather its administrative arms.253 this gives the people the perception that the states are not viable means to further their interests and discourages state-level participation. this of course impacts the ability of the states to facilitate the collective rebuke of federal policy.254 both of these outcomes harm the values of tyranny prevention and the enhancement of democracy. as for the .commandeering claims related to medicaid,255 the most harmful provisions for the values of federalism are those that dictate how the states can administer the medicaid program.256 this harms the value of competition by limiting state flexibility to administer the medicaid program in different ways, thereby finding the best policies by. trial and error.· fur­ ther, it destroys the ability of individuals to choose the state that best meets their policy preferences. this is not to say that congress cannot set mini­ mum standards for state medicaid programs, but only. that these standards should not reach the point where they compromise the role of the states in the federalist balance of power.257 249. id. 250. id 251. patient protection and affordable care act§ 1321, 42 u.s.c. § 18041 (2011) .. 252. see, e.g., second amended complaint, supra note 69, 1 53-60 (explaining the regulatory burden placed on the states by the act and the difficulties posed to state imple­ mentation). the fact that state governments with established regulatory infrastructures are struggling to implement the act's regulatory program for theit individual jurisdictions, raises questions as to how the federal government would be able to implement that program from scratch for all 50 state jurisdictions. 253. new york v. united states, 505 u.s. 144, 188 (1992) (arguing that congress cannot force states to adopt federal regulatory programs). 254. cox, supra note 3, at 1324-1325. 255. see second amended complaint, supra note 69, 1 83-86. 256. see the patient protection and affordable care act,§ 2001,42 u.s.c. 1396a. 257. see adler, supra note 135, at 208 (citing gonzales v. oregon 546 u.s. 243, 271 354 indiana health law review [vol. 9:1 this threshold is breached where federal control over state administra­ tion preempts all state efforts to account for local circumstances in operat­ ing the program. as mentioned above, the patient protection and affordable care act curtails state efforts to keep the costs of medicaid down by prohibiting restrictions on eligibility and requiring states to pro­ vide medicaid participants with .an extensive set of health benefits.258 it further eliminates state discretion in how the program is administered by putting in place comprehensive instructions for how the medicaid program is to be operated and presented to citizens.259 where, as with medicaid, the states enter into a regulatory ''partnership" with the federal government, through which services are provided to citizens that neither the states nor federal government could alone offer, the sovereignty of the states should be enough to invalidate federal legislative efforts to transform the regulato­ ry partnership into a set of federal dictates carried out by quietly compliant state governments. when the states lose all regulatory discretion, and as­ sume the role of passive administrators, the federal-state partnership ceases to further the value of state participation in the program. 260 as such, con­ gress should either allow the states to administer medicaid in a way that acknowledges state autonomy, or else assume complete control of adminis­ . tering the program. by threatening to take away medicaid funding from states that do not comply with the reforms discussed above, the act again compromises the political legitimacy of the states. it does so by hindering the states' ability to create policy that satisfies the needs of constituents. federal funding for medicaid makes up a large portion of the funds spent by states to provide health care to the indigent and elderly. 261 some scholars argue that medi­ caid has evolved into a de facto "obligatory'' program for the states to oper­ . ate,· because it so important to their citizens.262 because the. federal government has access to more revenue through its general taxing power (2006) (explaining that congress may set "uniform national standards" in the area of health care but commandeering state policy in this area is "off the table'')). 258. see patient protection and affordable care act§ 2702,42 u.s.c. § 300gg-l(a)(l) (2010); second amended complaint, supra note 69, at 1 52-54 (explaining the impact of new eligibility requirements on state capacity to administer medicaid). 259. see generally patient protection and affordable care act, § 1943(b)(a)(a), 42 u.s.c. § 1396w-3(b)(1)(a) (2011); § 1943(b)(a)(a), 42 u.s.c. § 1396w-3(b)(1)(a); § 1302, 42 u.s.c. § 18022 (requiring secretary to establish standards for essential benefits plan re­ quired for medicaid policies);§ 2002, 42 u.s.c. l396a(e)(14). 260. see, e.g., patient protection and affordable care act § 1311, 42 u.s.c. § 18031(d)(4)(b) (2011) (requiring the states to create a phone line citizens can call for infor­ mation about insurance provided by the state-exchange). this provision restricts the state's ability to administer the act's underlying program in a manner that best responds to local needs. 261. memorandum in support ofplaintiff's motion for summary judgment, supra note 123, at 44 (arguing that state residents would lose out on health benefit programs if federal funding stopped). 262. adler, supra note 135, at 215 (citing the argument that "medicaid has a political 'lock-in effect' that limits the ability of states to opt out of the program"). 20 12] challenges to the patient protection and affordable care act 355 and nation-wide tax base, it is an abuse of this power to use it to coerce states to comply with federal dictates, particularly where the funding is di­ rected toward such an important program. this is especially so since the states granted congress its monopoly over tax revenue through their ratifi­ cation of the sixteenth amendment, which they most likely would not have done with the expectation that congress would use the resulting revenue to further impinge on state legislative autonomy.263 beyond these expressive limitations, congress's spending power is textually limited to providing for the national defense and general welfare. where a state is denied access to federal health service funding based on its failure to administer the medicaid program to exact federal specifications, congress is not using its spending power to promote the "general welfare" because needy citizens of the de-funded state would be denied access to federal benefits enjoyed by similarly situated citizens domiciled in compli­ ant states. with conditional spending, congress can never promote the general welfare because the spending will only promote the welfare of citi­ zens residing in compliant states. as for the states, congress's use of its spending power to dictate federal priorities into state law does not promote the "general welfare" of the nation. while the specific dollars may ulti­ mately promote the general welfare of state citizens, the use of the spending power initially as a pivot for leveraging federal policy preferences against state regulatory autonomy in fact detracts from the general welfare by hin­ dering the realization of political values attributable to the proper operation of federalist government. however, conditioning the receipt of federal funds on the states' use of those funds to implement a general regulatory scheme aimed toward providing state citizens with needed services may be · constitutionally acceptable. requiring states to use federal funds to provide a service to its citizens promotes the general welfare. but in all circum­ stances, the amount of funds distributed by congress to an individual state should be determined by state population or relative programmatic need, and not the degree to which the state implements specific, non-substantive federal dictates. in this way, congress can address a national issue that in­ dividual states cannot afford to deal with alone by providing states with the requisite funds and a regulatory roadmap. this promotes the value of a strong central government while leaving state autonomy intact. from an expressive perspective, this type of federal funding regime would appropri­ ately portray congress's superior capacity to address national issues, and also further the concept of a cooperative federalism, in which mutual re­ spect for the sovereignty of the states and the federal government is consti­ tutionally enforced. 263. baker. supra note 191, at 212-14 (explaining tbat the states gave congress their monopoly on revenue voluntarily through the ratification of the 16th amendment, and it is used to impinge on state autonomy). 356 indiana health law review [vol. 9:1 to conclude, the constitution's textual limitations on congress's spending power fulfill the federalist purpose of creating a strong central government particularly suited to act on issues of national importance. congress's power to act is deliberately tailored to national issues, specifi­ cally the national defense and general welfare. with this in mind, the courts' endorsement of the modern conditional spending regime appears intellectually irreconcilable with the spending power's text and the federal­ ist principles it furthers. a common justification used to ignore such feder­ alist directives in the text of the constitution, is that over time the states have granted the federal government the authority it currently wields, and have consented to their diminished role in the political order. conditional spending is· one example of this phenomenon, as scholars argue that when the states agreed to take federal funds they consented to meet any regulatory conditions congress might attach to those funds. t his argument will be addressed in the following section. vi. an important counterargument one may argue that the states have consented to the expansion of fed­ eral power discussed in this note, and in tum knowingly sacrificed their regulatory autonomy.264 specifically, article v gives states the ultimate control over the fate of constitutional amendments.265 by ratifying the six­ teenth amendment, the states voluntarily created a federal monopoly over tax revenue.266 the states have further tied their own hands by restricting their tax power in state constitutions.267 through these actions, it can be argued that the states have voluntarily submitted themselves to conditional spending by the federal government, and in tum given up their expectation of regulatory autonomy.268 if the states tie their own hands in terms of rev­ enue generation, they cannot reasonably expect to regulate completely in­ dependent of federal handouts. and in tum, the federal government cannot be expected to make monetary grants to the states for no consideration. 269 264. see michael b. rappaport, reconciling textualism and federalism: the proper textual basis of the supreme court's tenth and eleventh amendment decisions, 93 nw. u. l. rev. 819, 864 (1999) (arguing that amendments have created a new constitutional order that reflects new risks to state sovereignty). 265. u.s. const. art. v. 266. baker, supra note 191, at 214 (citing lino a. graglia, from federal union to national monolith: mileposts in the demise of american federalism, 16 harv. j.l. & pub. pol'y 129, 130-31 (1993)} (arguing that the states voluntarily gave the federal government a monopoly on tax revenue and this bas been used to further diminish their regulatory autono­ my). 267. jd. at 212 (citing a few examples of state's limiting their taxing power by constitu­ tional amendment). 268. jd at 212-218 (outlining the practice of conditional spending imd its implications on state regulatory sovereignty). 269. ld at 212 (explaining that the states must submit to federal regulations in order to 2012] challenges to the patient protection and .affordable care act 357 giving up access to revenue is thus defined. as constructive consent to fed­ eral control of state lawmaking. likewise, the states sacrificed a portion of their political sovereignty by ratifying the seventeenth amendment thus leaving the election of sena­ tors to the people.270 without the ability to elect senators, it is argued that states cannot adequately protect themselves from coercive exercises of fed­ eral power.271 in this way, it is argued that by consenting to give up control over the election of senators, the states voluntarily submitted to the regula­ tory control of the federal government. this interpretation of the 17th amendment's effect does not consider the context in which it was drafted, or the constitutional values underlying the states' decision to ratify. in fact, the amendment was not a means to weaken states, but to decrease the time it takes to elect senators and eliminate corruption linked to the states' selec­ tion of senators. 272 these two purposes promote the federalist values of enhanced democracy and prevention of tyranny. democracy is enhanced by giving the people the choice of their representatives, while the preven­ tion of tyranny is promoted by eliminating corruption and also by removing a state control over the make-up of the federal government, thus fostering a more cooperative dual federalism. in this context it is hard to say that the seventeenth amendment should be construed as a limit on state sovereign­ ty, as the transfer of power made by the states served the purpose of pro­ moting inherent federalist values. even with the seventeenth amendment the states still maintain some constitutional control over the shape of the federal government through the electoral college established under article i, section 1, clause 2, and the article i, section 4, clause 1 power of the state legislatures to set the time, place, and manner for holding congressional elections.273 further, state governors must approve senate judicial ap­ pointments, giving the political apparatus of the state continued supervision of congressional activity which has a direct effect on the formation and operation of state law. returning to the sixteenth amendment, while the states undoubtedly consented to the transfer of taxing power to the federal government, this transfer of power cannot be expanded beyond those police powers the states expected to sacrifice in ratifying the amendment. nor can it be construed to reset the constitutional order created by the document's remaining provi­ sions. that is, this single transfer of power cannot be construed to comreceive funds, and where they do not like the federal policy they must decide whether to enforce the policy and take the money, or decline to enforce the policy and lose the attached funds). 270. rappaport, supra note 264, at 866 (explaining that the federalist dynamic has changed with the ratification of the seventeenth amendment). 271. id. at 866. 272. vikram david amar, indirect effects of direct election: a structural examina­ tion of the seventeenth amendment, 49 v and. l. rev. 1347, 1353 (1996). 273. see u.s. const. art. ii.§ l, cl. 2; u.s. const. art 1, § 4, cl. l. 358 indiana health law review [vol. 9:1 pletely reframe the institutional design of the constitution.274 this is espe­ cially true since the amendment was passed in 1913 at a time when nowhere near the degree of government regulation existed as exists today. the func­ tions served by state government in 1913 did not require the level of fund­ ing needed for state-provided services now considered to be essential. nor did the states expect the federal government to assume the regulatory role it serves today. in fact, at that time the supreme court considered the states to have tax immunity, and held that states could not be made to enforce fed­ erallaw.275 in turn, it is not reasonable to assume that when the sixteenth amendment was ratified, the states expected to sacrifice accesses to needed tax revenue, or to make themselves dependent on federal funding for regu­ latory activities they had not yet imagined. to argue otherwise requires the transposal of modem political circumstances onto decisions made by states governments ninety-eight years ago. in conclusion, consent justifications for increased federal control must be limited by an examination of the constitutional context in which the states • transfer of power was made, the reasons it was made, and the effect of the new amendment within the resulting constitutional order. where the states sacrificed a power to promote a federalist value, or at a time when the sacrifice of that power had a limited effect on its sovereignty due to existing legal conditions, it should not be assumed that the ratification of the amendment conferred the states' consent to serve a lesser role within the constitutional order. the argument that the states consented to serving a lesser role in the modem political order cannot be justified by reference to their ratification of amendments ninety-eight years ago, at a time when the federal government's exercise of such powers did not pose a threat to state sovereignty. vll. summary the patient protection and affordable care act expands the role of the federal government in the regulation ofhealth care. the act establishes a regulatory scheme and gives the states a hobson's choice to enforce its provisions or to sacrifice their participation in the regulation of health in­ surance. however, current federalist jurisprudence is inadequate to pro­ mote the values that underlie constitutional order. in particular, the anti­ commandeering rule does not accomplish its stated purpose to protect the regulatory autonomy of the states and prevent the federal government from 274. rappaport, supra note 264, at 866-867 (arguing thlrt it is possible to find immuni­ ties for states against conditional spending and commandeering even with the sixteenth and seventeenth amendments). 275. /d. at 866 n.150 (1999) (citing collector v. day, 78 u.s. 113 (1870) (holding that states were tax immune); kentucky v. dennison. 65 u.s. 66 (1860) (holding that states could not be compelled to enforce federal law)). 2012] challenges to the patient protection and affordable care act 359 treating the states like administrative puppets. in order to maintain the form of federalist government required by the constitution, the anti­ commandeering rule must be applied in a manner that treats the states as independent sovereigns. this can be accomplished by framing the thresh­ old of constitutional validity for a given exercise of federal authority, as the manner in which the action furthers the political values the constitution's federalist structure was created to promote. where federal regulatory ef­ forts disregard the sovereignty of the states and hinder their ability to act as viable political alternatives to federal authority, the corresponding law may be unconstitutional if it does not otherwise promote a value inherent to the federalist structure of constitutional governance. the value of a strong gen­ eral government capable of addressing national issues, for example, will outweigh the loss of other federalist values where congress assumes regula­ tory control over an activity within the reach of its enumerated powers but previously regulated by the states, so long as it does not unduly infringe on state sovereignty in the process. without a strong judicial rule to protect regulatory sovereignty, states have little recourse to federal action. they depend instead on federal politi­ cal institutions to create changes on behalf of constituents. this is not an efficient form of recourse, nor does it fulfill the states' role in tyranny pre­ vention. the proceedings against the patient protection and affordable care act give the courts the opportunity to establish such a rule. the states cite federalist arguments in support of their commandeering claims,276 as wells as in support of their arguments against the individual mandate.277 while the courts have acknowledged this position, each ultimately declined to use federalist principles as dispositive factors in determining the constitu­ tionality of the federallaw.278 even though the florida district court found the entire act void, this was based solely on its finding that the individual mandate is unconstitutional and non-severable from the reaming provisions. the act's challenged medicaid reforms and programmatic mandates were found constitutional by the florida court, while the constitutional deficiency of the individual mandate had nothing to do with the appropriate role of congress in federalist design of the constitution.z79 instead, the mandate was voided on syntactical grounds, supported by the premise that congress 276. see, e.g., second amended complaint. supra note 69,, 86 and 88 (arguing that medicaid reforms and health insurance mandates placed on the states deprive them of their sovereignty in dereliction of the 9th and loth amendments). 277. see, e.g., id. , 60 (arguing that the individual mandate acts to confer a general police power on the federal government, which is properly reserved to the states by the 1oth amendment). 278. see, e.g., florida ex rei atty. gen. v. united states dep't. of health & human servs., 780 f. supp. 2d 1256, 1306 (n.d. fla. 2011) (concluding that while the act clearly reverses traditional concepts of federalism, precedent does not allow the court to appropri­ ately address these issues). 279. see generally id. 360 indiana health law review [vol. 9:1 may only regu~te commercial "activity'' under the commerce clause, and the decision not to purchase insurance could not properly be defined as an "activity.'o280 what is worse, the eleventh circuit court of appeals con­ cluc:jed that the individual mandate was severable from the. remaining act, leaving the most constitutionally offensive provisions in place. under a value ... based application of the anti...commandeering rule, all of these provi­ sions would be unconstitutional because they undermine the federalist val­ ues of regulatory competition, enhancement of democracy, and prevention oftyranny. this alternative outcome would endorse the importance of such values and condemn political efforts to contravene the constitution's textu­ al mandates .. · by taking the narrower syntactical approach, the court has failed to fulfill its role in the constitutional system and has further degraded the already decaying rule of law. however, the supreme court still has the opportunity to invalldate the entire patient protection and affordable care act, and in tum strike a victory for constitutional governance. whether the court orien~ such a decision in federalist values or more specific concerns reprding the power of congress, the outcome would serve as a step toward enforcing the· constitution's deliberate limits on federal authority. 280. see, e.g., id. at 23. global healm initiatives and health system development: the historic quest for positive synergies peter j. hammer* & charla m. burill** "the struggle against human oppression is the strug­ . gle between memory and forgetfulness. "1 i. introduction ............................................................................... 568 ii. polffical challenges -the who's positive synergies .campaign ...................................................................................... 571 a. first expert consultation in geneva (may 29--30, 2008) ........ 572 b. second expert consultation in mexico city (august 4-5, 2008) 574 c. 3rd expert consultation in geneva (october 2-3, 2008) ........ 577 d. the lancet article and venice recommendations ................... 582 ill. theoretical challenges-conceptuauzing heal til systems ......................................................................................... 587 a. a team of rivals: 2000 world health report ........................ 587 b. a team no more: differences between the world bank and wh0 ......................................................................................... 592 c. confronting complexity: an introduction to systems thinking597 n. administrative challenges-me global fund's experience with.health systems ................................................................. 603 a. rourids 1-4 (2002-2004): is there any real there, therefor health systems? ........................................................................ 604 b. rounds 5-7 (2005-2007): experimentation, consultation but retrenchment ........................................................................... 609 c. rounds 8-10 (2008-2010): time, persistence and the power of adaptation ................................................................................ 618 v. community challenges-incorporating a role for cnil society .......................................................................................... 626 a. the convergence of civil society, community systems and health systems ..................................................................... 626 * professor of law and director of the damon j. keith center for civil rights, wayne state university law school. ** executive director of the north carolina board of dietetics/nutrition. · l. dr. halfdan mahler, address to the 6lst world health assembly (may 20, 2008) (paraphrasing milan. kundera. book of laughter and forgeti'ing (1978)) (transcript available at http://www.who.intlmediacentrelevents/2008/wha61/hafdan_mahler_speechlenl index.html). 568 indiana health law review [vol. 9:2 b. a functional approach to community systems ....................... 632 1. civil society a su"ogate health service provider ........... 632 2. communities as a bridge to the social-economic determinants of health ..................................................... 634 c. enabling the enabling environment: capacity building and learning ................................................................................... 636 vi. historical challenges-lessons from primary health care and alma-ata ••....••....•..•..•...•.•..........•............................... 643 a. the positive synergies campaign and the pre-history of almaala ......................................... ; .................................................. 644 b. connecting actions to communities-past and present ........... 651 vii. conclusion .................................................................................. 657 epilogue: globalfund'sround 11 cancelation ........................... 658 i. introduction global health initiatives ("ghis") have ushered in revolutionary changes in the international public health architecture. in the late 1990s, we were busy fighting over the price of essential aids drugs, without serious visions of implementing clinically effective hiv i aids treatment world­ wide.2 today, groups such as the global fund to fight aids, tuberculosis and malaria (global fund), the president's emergency plan for aids re­ lief ("pepfar"), the gates foundation and the global alliance for vac­ cines and immunizations ("ga vi") have initiated a wide range of public health programs across the planet that are starting to meaningfully link the global-to-the-national-to-the local. such news is not all good. the more gills try to do, the clearer it be­ comes how much their work is constrained by endemic weaknesses within the existing health systems of most developing countries. worse still, these fragile systems can be damaged by the distorting effects of ghis attempting to work through and sometimes around them. this article is not an effort to resurrect old debates between vertical and horizontal interventions or be­ tween selective and comprehensive primary care.3 rather, it is an effort to 2. peter j. hammer, differential pricing of essential aids drugs: markets, politics and public health, 5 j.int'l econ. l. 883 (2002) (examining efforts to lower the prices of essential aids drugs and broaden the scope of compulsory licensing under the world trade organization's agreement on trade-related aspects of intellectual property rights). 3. tensions between vertical and horizontal interventions are mainstays in debates over global health policy. vertical interventions are structured international programs that target specific diseases or objectives, often to the neglect of other public health problems. horizontal interventions are projects that stress multiple and integrated programs, often with insufficient focus, direction or resources. see generally anne mills, moss campaigns ver­ sus general health services: what have we learned in 40 years about vertical versus hor­ izontal approaches?, 83 bull.world health oro. 315 (2005). similar debates have 2012] global health quest for positive synergies 569 draw attention to the neglected and often invisible infrastructure that lies behind any successful public health intervention. no challenge is more central to the lives of disadvantaged people around the world than the chal­ lenge of constructing a new science of health system development ("hsd"), in real time, as gills continue to design and implement more ef­ fective public health programming. 4 this is the essence of the quest for "positive synergies." the relationship between ghis and hsd presents a range of difficult and complicated puzzles. but, there is good news based on the world health organization's ("who") positive synergies campaign ("psc") elevating the issue of hsd and its relationship to gills to the top of the global health agenda in relatively short order. "positive synergies" seek to define areas where the work of gills and hsd overlap and complement each other, examining how building health systems can further the disease­ specific work of ghis and where the disease-specific work of ghis can further the ends of strengthening the overall public health infrastructure. psc has further forged a political strategy and has begun to outline an intel­ lectual framework that should lead to a better understanding of what future steps should be taken. 5 this article examines these important efforts. complexity is a defin­ ing characteristic of the ghiihsd interface. the psc mantra is that health systems are "complex, context-specific, and changing!.6 as such, hsd is a diffuse and a moving target. moreover, gills and the entire international public health architecture are in a near constant state of flux, which creates expositional as well as organizational challenges. our goal is to give the reader a comprehensive understanding of the current quest for positive synraged between those who advocate selective versus comprehensive approaches to primary health care. see j. a. walsh and k.s. warren, selective primary health care, an interim strategy for disease control in developing countries, 301 new eng. j. med. 967 (1979); oscar gish, selective primary health care: old wine in new bottles, 16 soc. sci. med. 1049 (1982). the focus on "positive synergies" provides a frame that can potentially medi­ ate and perhaps even transcend these tensions. 4. we define health system development ("hsd'') to encompass the entire field of work on health systems, their operations and efforts to improve their performance, with a particular focus on developing countries. health system strengthening (''hss'') is a term of art that has arisen at the intersection of ghi and hsd, focusing on how ghls can work in a manner that enhances the operation of health systems. in our taxonomy, hss is a subset of hsd. 5. psc is a remarkably innovative policy making experiment. with psc, the who is embarking on an on open, process-oriented initiative with a conscious awareness: (1) that the unknowns of the endeavor dominate the knowns; (2} that learning and adaptation must be built into the very dna of the policy making process; and (3) that simultaneous progress must be made on the theoretical·as weu as the empirical front, all while holding together a sometimes fragile international political coalition. this unusual combination of factors alone makes psc an important case study for those interested in policy making processes more generally. 6. world health organization, maximizing positive synergies collaborative group, an assessment of interactions between global health initiatives and country health sys­ tems, 373 lancet 2137,2140 (june 20, 2009) [hereinafter psc lancet article]. 570 indiana health law review [vol. 9:2 ergies, as well as the numerous difficulties such efforts face. that said, it will not be a simple, linear narrative. in examining the relationship be­ tween gills and hsd, we have settled on five interrelated challenges­ political, theoretical, administrative, community and historical challenges.7 understanding these different challenges will provide the reader an appreci­ ation of the multidimensional relationships between ghis and hsd. part ii (political challenges) places the story of the who psc at cen­ ter stage, highlighting its effort to create the political space necessary for effective international cooperation, as well as the intellectual framework needed for future action. psc is an unusual example of an open, process­ oriented experiment in policy making. beyond the political dimensions of the problem, the psc narrative provides the uninitiated reader the back­ ground necessary to understand ghis, hsd and the concept of positive synergies. part iii (theoretical challenges) explores efforts to address the question of what health systems are and how one might develop a concep­ tual framework that could forge better synergies between ghis and hsd. limitations in existing theoretical understandings place serious constraints on future planning and action. part iv (administrative challenges) pro­ vides a comprehensive case study of the difficulties the global fund has encountered in attempting to implement policies that pursue its own objec­ tives, while trying to be sensitive to the needs of hsd. since its inception, the global fund has recognized the significance of hsd. moreover, given its structure and ethos, one would have thought that the fund was ideally situated to combine the efforts of a ghi with the objectives of hsd. de­ spite this, the global fund got off to a slow and unsuccessful start, and is only now beginning to make meaningful progress on the hsd front. part v (community challenges) considers where grassroots organizations and civil society fit within hds. recent efforts at community system strengthening (css), particularly in rural settings, are an essential piece of the overall ghvhsd puzzle. part vi (historical challenges) ends with a cautionary tale of the pri­ mary health care movement, which serves as a counterpoint to part ii's op­ timistic assessment of psc. the late 1960s and early 1970s was another era of ambition and optimism at the who, accompanied by a similar awareness of complexity and the importance of process-oriented policy making to seek new answers to old questions. these efforts faltered, as un7. the various "challenges" are presented as self-contained narratives. as such, the chronologies of a number of the stories overlap. the story of the political challenges (the psc process itself) covers the period 2008--09. the story of theoretical challenges (the con­ ceptual framework for hsd) covers a period from 2000-09. administrative challenges (the case study of the global fund) covers a period from 2002-10. community challenges (new efforts at community system strengthening) covers a period from 2008-10. historical chal­ lenges (the story of the primary health care movement) covers a period from the late 1960s to the mid-1980s. 2012] global health quest for positive synergies 571 derdeveloped notions of primary health care became enshrined in the 1978 declaration of alma-ata.8 the pre-history of alma-ata illustrates how the­ se types of process-oriented policy initiatives are inherently difficult to sus­ tain. history may well prove such efforts to be episodic cycles in the ongoing struggle against human oppression. a brief epilogue examines the implications of the global fund's tragic decision to cancel its latest round of grant funding in the wake of the global financial crisis. ii. political challenges -the who's positive synergies campaign it is easy to forget that global health policy is forged in a highly con• tested political environment. 9 in this sometimes volatile arena, the who psc has pushed the relationship between ghis and hsd to the front of the international health agenda in a campaign that could fundamentally trans.; · form the future of international public health. the who sponsored meet-· ings in may, august and october of 2008. these meetings culminated in the publication of the campaign's work in the june 20, 2009 issue of the lancet, an assessment of the interactions between global health initiatives 8. declaration of alma-ata, international conference on primary health care, alma­ ata, ussr (sept. 6--12, 1978), available at http://www.who.int/hpr/nph/docs/dec1aration_ almaata.pdf. 9. with the dawn of the new century, gins emerged and started to redefine the glob­ al health architecture, challenging the traditional dominance of the who and the world bank. in the years following. both the who and the world bank struggled to redefine their role and mission. significantly, each organization settled upon "health systems" as a central part of their new agendas. in 2007, the world bank published its health nutrition and popu­ lation ("hnp") sector paper, healthy development, arguing that hsd was essential to future · global health programming and advocatirig, based upon its alleged comparative advantage, that the world bank should play the leading role. world bank, healtiiy devewpment: .· the world bank strategy for health, nutrtilon, and population results (2007) . [hereinafter 2007healtiiy devewpment], available at http://siteresources.worldbank.org/ heal thnutritionandpopulation/resources/281627-1154048816360/hnp strat­ egyfinalapril302007.pdf. the year before, alexander shakow, a retired world bank consultant. prepared a report asserting that the global fund should remain narrowly focused . on those aspects ofhsd that were directly related to aids, tuberc::ulosis and malaria (verti­ cal aspects of its ghi mandate), while leaving it to the world bank to specialize in hsd more generally. alexander shak.ow, gwbal fund-world bank hniaids programs comparative advantage snjdy {2006), available at http://siteresources. worldbank.org/intiin aids!re8ourcesl375798-11 03037153392/gfwbreportfinalv er sion.pdf. partially in response to that report, the global fund ended an innovative, one-year experiment where it had independently financed hsd efforts through a separate window •. for further discussion of this episode see infra notes 196--212 and accompanying text. 2007 · was also an important year for the who, with the publication of 2007 everybody'$ busi­ ness: strengthening health systems to improve health outcomes. worid health org., 2007 everybody's business: streng1hening healm systems to improve health ourcomes: who's framework for action (2007) [hereinafter 2007 everybody's business] available at http://www. who.int/healthsystems/strategy/everybodys _business. pdf. 2007 everybody's business similarly proclaimed the importance of hsd, as well as the cen~ tral role it believed the who should play in its advancement.. 572 indiana health law review [vol. 9:2 and country health systems 10 and the subsequent high level dialogue of stakeholders, which produced the venice recommendations. 11 this section examines the evolution of that process and the intricate technical and politi­ cal agendas that psc has developed to guide future action. 12 a. first expert consultation in geneva (may 29-30, 2008) "in may 2008, the world health organization (who) convened a meeting that signaled the beginning of a broad-based, international consul­ tative process for driving forward the rapid development of global guidance on maximizing positive synergies between health systems and global health initiatives (ghis)."13 the first psc meeting was a consensus build­ ing exercise, based, in part, on the common desire to meet the millennium development goals ("moos"). the central motivation for the initiative was the belief that ghis and hsd are both essential to improving public health and that these objectives can be better accomplished through collabo­ rative efforts. ghis, such as the global fund, ga vi and pepf ar, have marshaled unprecedented resources and implemented concrete clinical ef­ forts that would have been thought impossible in past decades. the prob­ lem is that existing health systems are weak, too weak to meet the broad range of health needs that they are being asked to address. the underdeveloped state of health systems makes it difficult and per­ haps impossible for ghis to achieve their disease-specific objectives. at the same time, as ghis seek to work through and sometimes around exist­ ing health systems, there is a substantial possibility that they will distort, damage and further weaken these fragile structures. in sum, in a vicious circle, weak health systems can limit the effectiveness of the global health initiatives and the global health initiatives can place unwar­ ranted stress on already weak systems. this dilemma drives a wedge between health systems strengthening efforts and the work of the global health initiatives and limits the capacity of both to achieve their full po10. psg lancet article, supra note 6. 11. world health org., maximizing positive synergies between health systems and global health initiatives: initial recommendations (world health org., working paper) [herinafter venice recommendations], available at htlp:/lwww.who.int/healthsystems n enice _recommendations.pdf. 12. this is an exercise in storytelling relying principally on the who's own publica­ tions. it is not intended to be an authoritative history. 13. world health org., report on the expert consultation on positive synergies between health system and global health initiatives 1 (2008) [hereinaf­ ter 1st expert consultation), available at www. who.int/healthsystems/hs _ & _ghi.pd£ 2012] global health quest for positive synergffis 573 tential.14 on the positive side, if properly designed, actions taken in furtherance of the objectives of ghis could. also help strengthen domestic health sys­ tems and visa-versa. this is the essence of "positive synergies." the de­ velopment and exploitation of such synergies defines the cooperative framework driving psc. the questions then become "are these synergies being vigorously exploited by all stakeholders to ensl.ire maximum mutual added value? or are new opportunities for improving public health in low­ and middle-income countries being missed?"15 these are complicated questions with both technical and political dimensions. "[s]uccess will de­ mand work on two fronts: technical guidance," as well as "advocacy for a · change of mindset."16 psc's strategy is to push hardest on the technical side first, on the hope and expectation that a better understanding of the problem may increase the opportunities for the political consensus to be · maintained.17 the i st expert consultation outlined an ambitious agenda for building an intellectual framework capable of defining the scope of positive syner­ gies.18 this agenda will require a number of innovations in our understand­ ing of health services research. as much as anything else, psc is significant for its critique of the ability of traditional social science and pol­ icy making epistemologies to address complex global problems. "the re­ search endeavor will need to utilize multiple methodologies in order to capture knowledge wherever it exists. a particular challenge will be to find a methodology that can accommodate the possible disparities between in­ formation which is formally recorded and knowledge of 'the reality' that is only informally shared.''19 often, the practical knowledge of what needs to be done falls outside the frame of traditional "scientific" methods. how will this new technical framework be used? the intent is to cre­ ate an open architecture for policymaking that is capable of adapting itself 14. world health 0rg., maximizing positive synergies between health systems and global health inmatives 4 (2008), available at http://www.who.int/ healthsystems/maximizingpositivesynergies.pdf. 15. 1st expert consultation, supra note 13, at 2. 16. id at9. 17. as examined in greater detail in part iv, infra, gms. like the global fund. are open to being more active on hsd. a large part of the problem is that they simply do not know what to do. how willing gms will be to make substantial changes in their own policies and programs, however, is still an unresolved question. · 18. 1st expert consultation, supra note 13, at 2 (''translating this knowledge into action that is evidence-based demands the urgent development and implementation of a global policy and technical framework. this will serve to guide both health systems. and ghis, to ensure that mutual threats are recognized and avoided and that synergies are identi­ fied and built upon."). part of this process will entail a systematic review of the experiences, good and bad, of past and ongoing initiatives. id. at 3-5. 19. id at6. 574 indiana health law review [vol. 9:2 to different local contexts. "the guidance that is produced should aim to provide a flexible scaffolding from which different countries can draw and build on what is useful and relevant to their particular country situation.'.20 if this were not difficult enough, the policy making process is further in­ tended to be inclusive and participatory. "reaching and engaging key stakeholders, including decision makers, civil society, the private sector and affected communities, must be at the centre of the effort.'m all involved in psc understand.the urgency of the undertaking. there is no time to lose. the current commitment of country leaders, donors and international stakeholders to achieve the health-related mdgs offers a window of opportunity that mu8t not be missed. therefore the timeframe is ambitious. the aim will be to reach agreement on preliminary policy and technical guid:.. ance within approximately 12 months from the date of this expert consultation. 22 tlie label of ambitious for the preliminary psc agenda is a gross under­ statement. b. second expert consultation in mexico city (august 4-5, 2008) psc's dual political and technical tracks structurally defined its work in august 2008. there were two events. one session was a positive syn­ ergies panel at the xvii international aids conference. 23 this was a gath­ ering of some of the most important stakeholders in the ghiihsd debate. the panel discussion worked the political end of the problem, and empha­ sized areas of alleged "growing consensus."24 the other event was the psc's 2nd expert consultation. this consultation focused on further refining the technical aspects of the agenda.25 · the international aids conference panel consisted· of a who's who of global health, with leading representatives from the who, the gates foun20. id. at9. 21. id. 22. id. 23. world health org., the mexico panel on maximizing posmvesynergies between health systems and global health inmatives: a who satellite meeting at the xvii international aids confer:ence, mexico city, 4 august, 2008 (2008) [hereinafter ~co panel], available at http://www.who.intlhealthsystems!ps_mexico pane1report2b.pdf. 24. /d. at4. 25. world health 0rg., report on the 2nd expert consultation on posmve synergies between health systems and global health initiatives, mexico city, 5 aug. 2008 (2008) [hereinafter 2nd expert consultation], available at http://www.wbo. int/healthsystems/possyn2ndexptcons _ hr.pd£ 2012] global health quest for positive synergffis 575 dation, the global fund, unaids, pepf ar, the world bank, academics, and national governments. how does one gain consensus and garner effec­ tive cooperation in such an environment? given the absence of binding international law, the dynamics ofthis problem have more in common with private corporate law than with traditional public law. undertakings like the psc can only succeed if there is a framework in which all actors per­ ceive that cooperation is in their own organizational self-interest. from this perspective, one can appreciate the power and wisdom of 'l>ositive syner­ gies" as a cooperative framework. by definition, if something is a positive synergy, it constitutes one of those rare win-win scenarios, falling within the perceived self-interest of all involved in theory, at least, everyone should be willing to agree to pursue authentic positive synergies. the difficulty is in credibly identifying the scope of real synergies at the ghi-hsd interface. this involves complicated theoretical and empiri­ cal questions. there are a number of conceivable relationships between ghis and hsd: fiqure 1 figure2 figure3 figure4 ghis and hsd could be completely unrelated. ghis could be viewed as a subset ofhsd. hsd could be viewed as a subset ofghis. alterna­ tively, ghis and hsd could be viewed as constituting two separate but in­ tersecting domains. most would agree that separate but intersecting ghis and hsd domains is the most appropriate frame, but this does not reveal the size of the intersection (positive synergies), and, hence, the feasible do­ main of win-win cooperation. figure 1 figure2 figure3 psc's primary gamble is to work the technical side of the equation, hoping that it will credibly demonstrate a large overlapping area of positive synergies, and, hence, a large domain for prospective international coopera­ tion. if this is the strategy, then the short-term political objective is to min­ imize potential disagreements and to hold the coalition together long 576 indiana health law review [vol. 9:2 enough to deliver on the technical mandate. this approach is exactly what psc tried to do. the body of the report summarizing the results of the mexico panel is captioned, ''the mexico panel-a growing consensus.',a6 the document indicates that there is re­ ported consensus on the nature of the problem: "[ w ]ithout properly func­ tioning health systems, neither disease-specific initiatives, nor comprehensive health services can achieve satisfactory and sustainable out­ comes.'m there is reported consensus around the nature of the agreed4o cooperative framework: this is the right time to develop consensus around ev­ idence-based guidance on maximizing positive syner­ gies between health systems and all global health initiatives. . . . the challenge is to generate mutual added value for both health systems and disease­ specific work by ensuring the greatest possible syner· · gy between the different investments. 28 there is further agreement about the nature of the daunting technical chal­ lenges involved in defining positive synergies: health systems are complex, existing data are inadequate and there is no agreed upon conceptual :frame­ work. 29 addressing these issues is the responsibility of the technical track.30 other areas of reported consensus have the overtones of doing what­ ever is necessary to maintain the political coalition while the technical is­ sues are addressed. the report lavishly praises the existing efforts of ghis.31 furthermore, the who makes it clear that psc is. not a trojan horse seeking the reallocation of resources from ghis to hsd.32 finally, the who is trying to ensure that psc does not become a forum to rehash old debates, such as those about vertical versus horizontal initiatives or comprehensive versus selective primary care. the focus must remain on a common future.33 this may be easier said than done. 26. mexico panel, supra note 23, at 4. 27. id 28. id. at6. 29. id at5. 30. one striking and significant aspect of psc is its willingness to acknowledge both what is known and what is unknown. ironically, consciously acknowledging the ''un­ knowns" may actually help create the political space the project needs to proceed­ participants must give the technical process snfficient time to develop a defensible roadmap. 31. see mexico panel, supra note 23, at 4 ("disease-specific initiatives have made a defining impact ... and helped save many lives .... [c]are should be taken not to jeopardize these much needed investments."). 32. id at 5 ("stakeholders can be assured that the objective is to make better use of all the available resources, and to leverage new and additional resources for public health."). 33. id at6. 2012] global health quest for positive synergies 577 the meeting of the 2nd expert consolation focused almost exclusive­ ly on the technical side of the positive synergies mandate. this is a daring gamble-trying to maintain a fragile political coalition, while hoping to make technical progress on a problem that is immensely complicated, if not intractable. the paper outlined a strategy to pursue three simultaneous tracks: (1) an academic track, (2) a civil society track and (3) an implement~ er track composed of those who will have to put any new proposals into practice.34 as a "starting point'' for the conceptual framework, the 2nd ex­ pert consultation adopted the who's preexisting view of health systems­ a series of interconnected building blocks-which was outlined in the 2007 who report, everybody's business.35 c. 3rd expert consultation in geneva (october 2-3, 2008) "in october 2008, the [who] convened the third expert consultation to progress the work on maximizing positive synergies between health sys­ tems and global health initiatives (ghis)."36 the primary focus was on the technical aspects of the ghisihsd challenge. review of the existing evi­ dence revealed that there was a dearth of research that met "conventional" standards. 37 the evidence that did exist suggested that there are unlikely to be any universal, simple or comprehensive solutions. the question of whether greater integration within a health system increases or decreases the possibilities for positive synergies illustrates this point. 38 one reason why generalizations about integration are difficult and dangerous is that local context is important and can have significant and varying impacts.39 i d. arguments that promulgate the view that disease-specific initiatives and health systems strengthening exist in opposition, rather than in harmony, risk becoming counterproductive. if the millennium development goals are to be reached, all those committed to global health must work to­ gether to produce the best possible health outcomes. all parties agree that any emerging divide must be urgently and satisfactorily resolved. 34. 2nd expert consultation, supra note 25, at 2-3. 35. id at 3. the building bloch of a health system consist of: (1) service delivery, (2) health workforce, (3) information, (4) medical products, (5) financing and (6) governance. 2007 everybody's business, supra note 9, at vi. 36. world health oro., report on tile 3rd expert consultation on maximizing positive synergies between health systems and globe health initiatives, who, geneva, 2-3 october 2008, at 1 (2008) [hereinafter 3rd expert consultation] available at http://www. who.intlhealthsystems/possyn3rdexpcons _ hr. pdf. 3 7. id at 2 ("despite the intensity of debate around the integration of programmatic interventions into health systems, the results of a comprehensive systematic review of the existing evidence found very little evidence that was considered sufficient to meet conven­ tional research expectations."). 38. id. at 3 ("it is not possible to reach any firm conclusion on the question of whether an integrated health programme delivers better outcomes than a non-integrated programme because sufficient evidence on causality is not available."). 39. id ("the few published studies that document the integration of programmatic 578 indiana health law review [vol. 9:2 psc's technical challenge is to define new research questions and to devel­ op methodologies to address these types of questions. while it is a bold statement, the report is correct in its assessment that the "longer term agen­ da will, in effect, be about building a new science for health system re­ search. ,,4o the 3rd expert consultation outlines the agenda for the three psc tracks: the academic, civil society and lmplementers panels. the broad research question for the academic panel is straightforward: "[h]ow can ghis and national health systems optimize their interactions to capitalize on positive synergies and minimize negative impacts thereby achieving their common goal of improving health outcomes?'o41 while still somewhat ill-defined, the conceptual framework that will guide the project's initial inquiry is a blend of the traditional who building block understanding of health systems, with recognition of various plus factors such as the im­ portance of interconnectedness and complexity.42 once again, even this is ambitious. openly recognizing complexity raises numerous challenges for conventional methodologies. "[t]he attempt to shed light on complex sys­ tems and relationships is a relatively new field of research and one which neither quantitative nor qualitative research methods alone will capture suf­ ficiently .'.43 how does one go about approaching these research questions? "meet­ ing the challenge presented by the subject matter will require creative ap­ proaches that extend the frontiers of traditional research methodologies.'m the paper provides some specific guidance. first, context is key. the foremost challenge will be to capture the many contextual factors that can impact the interactions be­ tween ghis and health systems. research methodolinterventions with health systems find that the results of integration vary widely depending on the context"). 40. ld. at 11. 41. i d. at 5. more specifically, the academic panel will examine the following issues: jd. at 7. a) identify relationships between ghi-funded progranunes and health systems in varied country contexts; b) understand these relationships by establishing which factors influence the extent and nature of the interaction between ghi-funded progranunes and local health systems; c) understand the impact by identifying the specific system de­ signs and delivery strategies that have led to the most positive impacts and exploring how these designs and delivery structures influence the coverage of targeted and non-targeted interventions and health outcomes. 42. id ("it was stressed that the [building block} framework has limitations and is not being proposed as a health systems framework for any other purpose tha[n] to help organize the current progranune of work."). 43. jd. 44. jd. at5. 2012] global health quest for positive synergies ogies must be sensitive to the fact that health systems are neither homogenous nor static and are subject to a wide range of social and political determinants. the work on positive synergies must show attention to such complexities and strive to produce a robust evi­ dence base that combines context-independent find­ ings that can be generally applicable, and context­ specific examples that can provide inspiration. by doing so, the work will test and challenge some of the thinking that exists and generate validity for best practice.45 579 second, researchers should employ mixed-methods. "there was agreement that a 'mixed-method approach' is an appropriate methodologi­ cal response to the complexities inherent in the research agenda. a 'mixed­ method approach' can encompass quantitative and qualitative research and allow the use of new, alternate and unconventional information sources as well as involving multi-disciplinary teams.'.46 finally, learning and adapta­ tion must be an endogenous aspect of the research and ultimately the im­ plementation process. ''the meeting agreed that the work on positive synergies must strive to achieve a beneficial cycle of action guided by learning, and learning informed by action. "47 the initial research, produc­ tion of preliminary guidelines, and actual implementation must all be part of an open and ongoing process containing multiple feedback mechanisms. the civil society panel faces comparable challenges. psc is innova­ tive, in part, because of its efforts to incorporate civil society in its multiple roles of stakeholder, implementer and research subject.48 if one wants b,> 45. id. at6. 46. id. what does this mean in practice? with respect to the mixed-methods methodologies, the goal is a constant process of triangulation: id. at7. 1. global cross-country quantitative . analysis-will look across many countries for the existence of statistical relationships between ghi investment and the inputs into and outputs from country health systems. 2. country level mixed-methods analysis-a series of studies that will investigate the operational detail of health care delivery and imple­ mentation to begin building theories about why the relationships (as identified in the cross-country analysis) exist. these are mixed methods studies that will use quantitative methods when possible to triangulate with qualitative results. 3. provider unit level analysis-to gather data that will shed light on the impact of different system designs at the point of health care de­ livery. 47. id at6. 48. id. at 8 (civil society actors are engaged in many different roles that have a bearing on the relationships between health systems and ghis, including as service-users, advocates, and serviceproviders. it follows that, while the civil 580 indiana health law review [vol. 9:2 effectively link gills and hsd one must ultimately connect the global with the rural-local. civil society will play an indispensable role in this process, and therefore, must be a critical part of the research agenda. the specific research questions defined by the 3rd expert consultation for the civil so­ ciety panel are as follows: (a) identify how and in what ways civil society participation can assist in maximizing positive synergies between oms and health systems; (b) understand and appreciate the views of civil society on how to maximize positive synergies; (c) increase awareness of the views of civil society on the modifications needed to increase the responsiveness of gills. 49 this, also, will require new types of research methodologies. 50 the civil society track is employing action research where traditional lines between academic and social practices are blurred. it is also another illustration of the need to make learning endogenous to the very process of research and implementation. the lmplementers panel will play a different role from that of the ac­ ademic and the civil society panels. psc's approach is very pragmatic. to be effective, the end results must face real time political and logistical reality checks. "the implementers will not undertake original research but will play an advisory and an advocacy role, particularly in relation to the implementation of the who guidance that results from the work.',s1 while the majority of the report from the 3rd expert consultation fo­ cuses on technical aspects of the ghis!hsd problem,. the political chalsociety partners enjoy valuable insight and access to civil society networks, the work must strive to achieve a balance between a descriptive, analytic and advoca­ cy role.). /d. 49. /d.· 50. id. the paper outlines the following methodologies to be employed: 1. key informant interviews and semi-structured focus group surveys with country implementers, community health workers, advo­ cates, and civil society policy makers (e.g. global fund country coordi­ nation mechanism members). there will be a focus on obtaining · information from grassroots and underrepresented marginalized constituencies. · 2. real-time action learning will create a feedback "loop" between learning and doing. the reseaj'ch will seek to identify where civil society is already using existing opportunities at [the] country level to maximize positive synergies between disease-specific interventions and health systems. such light as can be shed on current good practice and will feed into the development ofwho guidance. 51. id. at 9. the lmplementers panel consists of representatives from oms, recipient countries and non-governmental implementation bodies. one objective is to help ''bridge the gap between research findings, recommendations and implementation by fostering country participation and by ensuring that the reality of country experience is taken into account at all stages." id. 2012] global health quest for positive synergies 581 lenge of maintaining the cooperative framework is an important subtheme. the report's summary of existing evidence is willing to indirectly criticize ghls by stating that "[ d]isease-specific initiatives have not created signifi­ cant additional capacity in health systems."52 the report is careful, howev­ er, not to make any direct criticisms. "despite the emerging evidence of stresses, particularly on the human resource capacity of health systems, there is no conclusive evidence to suggest that hn/aids-specific initia­ tives have produced adverse effects on other areas of health service delivery or health outcomes."53 the claim of no "conclusive evidence" of damage may be correct according to conventional research standards, but it stands in interesting tension with the paper's critique of the inadequate state of extant social science research. in the end, psc is willing to employ different standards in pursuit of its political and technical objectives. this is under­ standable. to be successful, psc must maintain its political consensus. politics and a complete fidelity to the truth are not always compatible ob­ jectives. the psc formula for maintaining political consensus takes more de­ finitive shape in the paper. it can be summarized as follows: first, the pre­ sent moment is no time for blame. 54 second, the positive synergies frame will remain a faithful statement of the underlying cooperative framework. future action will be restricted to win-win options in the perceived self­ interest of all stakeholders. parties will not cheat on the framework and the campaign will not be used as a surreptitious effort at resource realloca­ tion.55 third, parties must avoid rigid, ideological positions. 56 as such, the process should focus on common goals, not areas of disagreement. "reach­ ing the hard-to-reach, including rural and marginalized communities, is now the major challenge facing all those involved in global public health and in disease-specific initiatives and health systems alike. "57 52. ld. at4. 53. ld. (emphasis added). 54. i d. at 11 ("the focus must be on a counter-factual approach that can describe what might be achieved if things are done for the best and draw on this understanding to move forward."). 55. jd. ("it is essential that the work should not lead to any de facto cuts in disease­ specific spending but rather contribute to additional impact and real increases in resources."). jd. 56. jd the debate around the interplay of disease-specific health initiatives and health systems has been characterized in the past by a polarization of views that can prove reductionist and counterproductive. the effort on maximizing positive synergies aims to nurture a new spirit of coopera­ tion and this demands that passionately held positions should be set aside. 57. id. 582 indiana health law review [vol. 9:2 d. the lancet article and yenice recommendations the first phase of psc came to completion with the publication of an assessment of interactions between global health initiatives and country health systems, in the june 20, 2009 issue of the lancer8 and the subse­ quent convening of the high level dialogues held in venice, italy on june 22-23, 2009.59 this is not the pl~ to summarize the substantive findings of the who's year-long examination of the interface between ghis and hsd. for that, one should read the article itself, as well as the final reports of the academic60 and civil society panels.61 instead, this section exam­ ines the conceptual model of health systems underlying the project's analy­ sis, reflects on psc as a novel type of open, process-oriented policy making and considers psc's recommended next steps. any effort to forge potential synergies between ghis and hsd ·re­ quires a conceptual framework that, among other things, defines what a health system is. psc employs what is best thought of as. a building­ blocks-plus framework for understanding health systems.62 the who's building blocks of a health system consist of: (1) service delivery, (2) health workforce, (3) information, (4) medical products, (5) financing and ( 6) governance.63 the plus factors stem from an appreciation that, in isola­ tion, the building blocks provide only a static and rigid framework, one in­ capable of fully capturing a country's health system. which plus factors to · include and how they are described often varies. one factor is a focus on the interconnectedness of the building blocks.64 related factors reflect con­ cerns of complexity, localism (content-specificity) and dynamism. in the psc's phraseology: "health systems are complex, context-specific and changing.'.65 an additional plus-factor is the role that civil society unavoidably plays in the functioning of the health system. 66 . the relationship between the community and the building block as­ pects of health systems is captured in figure one of the lancet article, conceptual framework of the interaction between global health initio58. psc lancet article, supra note 6. 59. venice recommendations, supra note ll. 60. world health or.g., the ma.xjmizinq positive synergies academic consortium, interactions between global health inrnatives and health systems: evidence from countries (2009). 61. world health oro., the maxjmjzing positive ·synergies cml soetety consortium, interactions between global health inrnatives and health systems: evidence from coun'iries (2009) [hereinafter finalreportcml society consortium]. 62. psc lancet article, supra note 6, at 2139-40. 63. ld at2140. . 64. id ("although these building blocks help to clarity the essential :functions of health systems, efforts to address health systems should recognise the interdependence of each part of the health system."). 65. id 66. id 2012] gwbal health quest for positive synergies 583 tives and country health systems.61 in this framework, both ghis and country health systems directly impact the five building blocks of govern­ ance, financing, health workforce, health information systems and sup­ ply management systems, which are then influenced by the community to affect health service delivery. 68 health service delivery, in tum, deter­ mines health outcomes. this is a helpful starting point, but the article acknowledges that the conceptual framework "is not optimal" because it does not adequately capture the various plus factors associated with the health system, nor the fact that the entire health system, as well as individu­ al health outcomes, are influenced by broader "economic, social, political, environmental, and other factors that are not included in our analysis. '.69 critical to the success of future efforts will be their ability to fill in and supplement the components of the building-block-plus framework for hsd. in this process, theories underlying the various plus factors must be developed and integrated· back into the foundational understanding of the role the various building blocks play individually and in combination. the three most importantplusfactors are: (1) context-specificity, (2) intercon­ nectedness, and (3) the role of people and civil society. building-block-plus framework for hsd b ild. bl ks u idg oc pi f ct usa ors governance context-specificity finance (institutional economics) health service delivery interconnectedness health work force (complex adaptive systems) health information system civil society medical products (community system strenf!(henin$!) each plus factor can be associated with. a different set of tools and theories. the tools of institutional economics can assist in understanding issues of context-specificity.70 recent work in complex adaptive systems can be ap­ plied to address issues ofinterconnectedness.71 finally, work on communi­ ty system strengthening (css) can help address the plus factor of civil society.72 without doubt, these are complicated issues, but such complications are an inherent part of any honest effort to address this type of problem. conventional policymaking, social science methods and systems of data 67. /d. fig.l. 68. id 69. id 70. see infra part iii.a. 71. see infra part iii. c. 72. see infra part v. 584 indiana health law review [vol. 9:2 collection often fail to appreciate this fact as a result, conventional tools are frequently of little use in providing credible insight at the interface be­ tween ghis and hsd. what is as refreshing, as it is unusual, is how frank psc is about the nature of these difficulties and how ambitiously it is com­ mitted to trying to transcend the limits of traditional approaches. after spending twenty pages summarizing the findings of its year-long examination of the individual building blocks of the health system, the arti­ cle begins a section captioned what we know and what we do not know. 73 despite the amounts invested and the important part played· by health systems and ghis, investigators do not have appropriate methodst or sufficient incentives (largely as a result of insufficient investment and po­ litical will), to assess the quality and effectiveness of the complex and context-specific interactions between health systems and ghis. the paucity of robust evi­ dence is testament to these methodological and other shortcomings. 74 the complexity ofthe problem, the absence of information and the limits of existing methodologies must affect the very process of future policy mak­ ing. this is a formidable, but exciting undertaking. what is called for is the co-construction of policymaking, theoretical :framing, empirical meth­ odologies, evidence gathering, learning, feedback and adaptation. psc is aware of these challenges. 75 jd no rigorous studies exist in which the effect of ghis on health systems has been prospectively examined. in view of the amounts of resources that are being in­ . vested in health systems, new efforts are needed to improve data gathering, and new methods should be designed to specifically measure and investigate 73. psg lancet article, supra note 6, at 2160. 74. /d. 75. jd. at2161. two points have become clear from our assessment. first, ghis and country health systems are not independent but are inextricably linked. second, the two are dynamic, complex entities, such that examination of their interactions cannot be a simplistic, single variable, linear analysis, therefore raising caution about generalisations. moreover, although the ghis that we have focused on share key features, the many variations that exist between them contribute to the determination of their different effects on country health gystems. 2012] global health quest for positive synergies 585 health systems. 76 this will not be easy. psc ends this ftrst phase of its work with a set of recommendations on how to move forward in this difficult environment. 77 according to the lancet article, the ''purpose of these recommendations is to increase and expedite efforts to address the gaps in knowledge, and to encourage the cre­ ation of a new framework in which the disease-specific and health-systems approaches are mutually interdependent and have a common goal to im­ prove the health of all people."78 the working paper produced by the high level dialogue in venice outlines a complementary set of recommenda­ tions and makes a bold pronouncement.79 "the venice recommendations lay the foundations for a new paradigm in global public health-one in which more consistently productive and constructive interactions between global health initiatives (ghis) and country health systems will mean bet­ ter value for money and better health outcomes.',so the short version ofthe venice recommenda~ions is: (1) be bold; (2) set targets; (3) enhance leadership; (4) engage communities; and (5) im­ prove evidence. being bold entails "[i]nfus[ing] the health systems strengthening agenda with the sense of ambition, the scale, the speed, and the increased resources that have characterized the ghis."81 this is likely to be an ongoing political challenge. despite the undeniable truth that health systems are essential, it is difficult to generate enthusiasm, in any policy setting, for the infrastructure of public action. infrastructure is bor­ ing. directly saving individual lives is exciting. being bold over a long period of time will take effort and creativity. the recommendation of "set­ ting targets" entails agreeing on "clear targets and indicators for health sys­ tem strengthening."82 one of the innovations propagated by ghis has been the use of results-based financing. the difficulty with health systems, how­ ever, is that there are few clear, objective targets or performance measures. while targets are important, it is equally important that those targets be flexible and properly updated with improved understandings. rigid and misguided targets could be worse than no targets at all. there is an interesting difference between how the recommendation of "enhancing leadership" is characterized in the lancet article versus in the venice recommendations. the lancet recommendation is as follows: "(i]mprove alignment of planning processes and resource allocations among 76. /d. 77. /d. at 2161-63. 78. /d. at 2161. 79. venice recommendations, supra note 11, at 2. 80. /d. at2. 81. /d. 82. id. at4. 586 indiana heal til law review [vol. 9:2 ghis, and between ghis and country health systems."83 the venice rec­ ommendations, in contrast, has an almost exclusive in-country focus: "[p ]romote country capacity for strong national planning processes and bet­ ter alignment of resources with national planning processes. ,,34 in fact, both are needed. greater international harmonization is a perennial challenge, a fact acknowledged in the paris declaration. 85 there is also a need for greater leadership (and capacity building) at the national level, country-led processes for defining national priorities concerning health system devel­ opment, better coordination between countries and oms and harmonization amongst ohis themselves. the multiple tiers connecting the-global-to-the­ national-to-the-local must all be kept in mind. the recommendation for "engaging communities" is recognition of the importance of localism and the increasingly significant role of civil so­ ciety in global health. the old adage is that all politics are local. this is even truer with health care. again, many ghis have pioneered efforts to improve community participation in public health governance. given the weaknesses in many national administrative and bureaucratic structures, new forms of collaboration with communities and with civil society will be critical for improving health systems. as recognized by the civil society panel, the interface between a civil society, oids, hsd and the nation-state will require its own new theorizing and intellectual agenda. the last recommendation may be the most important of all: improve evidence. "improve evidence-based decision making in health by building the capacity of countries to generate and u.se knowledge. ,,86 this reflects the need for openness, adaptation and learning in forging policy under con­ ditions of complexity and uncertainty.87 this will not be an easy task to sustain over time. but, this is also what makes the psc so important and unusual from a standpoint of policy studies. · the rest of this article is de83. psc lancet article, supra note 6, at 2162. 84. venice recommendations, supra note 11, at 4. 85. paris declaration on aid effectiveness: ownership, harmonization, alignment, results and mutijal accountability (2005), available at http://www.alliance2015.orglfileadmin/user_upload/paris_declaration_on_aid_effectivenes s_.pdf. i d. 86. venice recommendations, supra note 11, at 6. 87; id. the venice recommendations outline the difficulties: efforts to assess the quality and effectiveness of health systems and of the complex and context-specific interactions between health systems · and gills are challenged, in part. by a lack of appropriate tools for anal­ ysis. evidence generation is also dependent on the collection of good quality data through well-functioning country health information sys­ tems. new approaches to heatth systems strengthening, and to scaling up services for targeted diseases, must be lj.ccompanied by appropriate country-based operational research that can support better evaluation with an emphasis on interactive learning and "learning by doing." 2012] global health quest for positne synergies 587 voted to exploring the challenges inherent in these efforts and what might be done to improve psc's chances of success. iii. theoretical challenges-conceptualizing health systems developing a workable conceptual framework to explain what health systems are and how they operate will be critical to forging positive syner­ gies in the future. the notion of building blocks provides a useful, even if incomplete, foundational set of intuitions. the objective of the building­ block-plus framework is to incorporate additional concerns such as (1) context-specificity, (2) interconnectedness, and (3) civil society. each of these plus factors, in tum, can be associated with a theoretical perspective that can permit its further development. context-specificity can be associ­ ated with theories on institutional economics. interconnectedness can be associated with theories of complex adaptive systems (systems thinking). finally, civil society can be associated with theories of community system strengthening ("css"). significantly, previous work by the who, largely neglected by psc, already exists that sheds important light on the question of context­ specificity and the application of the tools of institutional economics to health systems. this work is the 2000 world health report, health sys­ tems: improving performance ("2000 whr").88 these lessons need to be reexamined and reclaimed. shortly after the psc lancet article was pub­ lished, the who-affiliated alliance for health policy and systems re­ search ("ahpsr") issued a report, systems thinking for health systems strengthening (systems thinking), examining the challenges of intercon­ nectedness and complexity.89 this section traces the development of inter­ national theorizing about health systems from the 2000 whr through systems thinking to sketch the outlines of a viable conceptual framework for hsd. the plus factor of civil society will be examined in part v with an exploration of community system strengthening. a. a team of rivals: 2000 world health report the issue of hsd first emerged on the international radar screen with the publication of the 2000 whr. a little recognized fact, however, is that the 2000 whr was the unusual product of a team of rivals, produced by a 88. world health 0rg., the world health report 2000: health systems: improvjng performance (2000) [hereinafter 2000 whr). 89. alliance for health poucy & systems research & world health 0rg., systems thinking for health systems strengthening world health organization (2009) [hereinafter systems thinking], available at http://whqlibdoc.who.int/publications/ 2009/9789241563895 _ eng.pdf. 588 indiana health law review [vol. 9:2 collection of world bank and who economists and health experts.90 it is an important document in the history of global public health, but unfortu­ nately, it is also a largely forgotten document. understanding its origins helps explain both its significance and subsequent neglect. in opening the report, the reader is in for a number of surprises. while the whr is the flagship publication of the who, the document is clearly written by econ­ omists, not an epistemic community typically associated with the who. furthermore, the brand of economics contained in the report is not that of conventional neoclassical theory; it fits much more comfortably in the do­ main of institutional economics. 91 there is yet another surprise when one looks at the list of principal writers and finds a team heavily comprised of world bank economists. the 2000 whr is a document that the who could not have unilaterally produced, drafted by a group of world bank economists, who probably could not have published the same work at their home institution. it is an exotic hybrid, but as horticulturists are well aware, not all exotic graphs take hold. certain aspects of the report's eco­ nomic reasoning were stillborn inside the who and did not bare fruit after the departure of the world bank economists. at the same time, a number of the lessons of the 2000 whr did take root at the world bank, at least within its health nutrition and population ("hnp") section.92 inside the who, the 2000 whr is largely remembered for initiating the building block framework for understanding health systems.93 what is forgotten, however, is why the 2000 whr was focusing on particular health system functions in the first place. the focus on health system functions 90. 2000 whr, supra note 88, at ii (listing principal writers). 91. the stamp of institutional economics is clear in the 2000 whr. these tools and perspectives are responsible for a number of the report's innovative contributions. the re­ covery of these lost insights will be an important resource for the next phase ofpsc's work, particularly as it wrestles with the context-specific aspects of health systems. institutional economics affords a useful temperament for policy analysis, as well as a flexible set of tools. it should be acknowledged, however, that the tools of institutional economics are seldom definitive in their application. moreover, work in this field is still tentative and like other aspects of the conceptual framework for hsd still require additional development and re­ finement. 92. these lessons are reflected in subsequent world bank publications, such as the 2007 hnp sector paper 2007 healthy development, supra note 9. surprisingly, however, there is not a single citation to healthy development in the psc lancet article or in any of the preceding psc reports or expert consultations. 93. the 2000 whr initially identified only four functions (building blocks): (1) stew­ ardship, (2) financing, (3) creating resources and (4) delivering services. 2000 whr, supra note 88, at 25. in subsequent analyses, the who subdivided the creating resources building block into its labor (workforce) and non-labor (medical supplies) components. 2007 everybody's business, supra note 9, at vi. the last stage of the evolution of the contem­ porary building block framework was the addition of information as a distinct building block for health systems. the significance of information, however, is extensively discussed in the 2000 whr. 2000 whr, supra note 88, at 129-32. this process yielded the six building blocks framework found in the 2007 who publication 2007 everybody's business and sub­ sequently employed in psc. 2012] global health quest for positive synergies 589 was part of a larger argument that the what (functions) in health systems needs to be separated from the how.94 the separation of form and function is one of the most important teachings of institutional economics-many different organizational forms can accomplish the same identical function.95 determining which organizational form is most appropriate depends heavi­ ly upon a country's culture, history and the composition of other prevailing institutions (context).% in deciding which one of two (or more) institutional forms is most ap­ propriate, policy makers need to engage in a process of comparative institu­ tional analysis.97 this consists of a careful, side-by-side examination ofthe strengths and weaknesses of each alternative, based on their likely perfor­ mance under real world conditions. this should be approached as an em­ pirical and not an ideological undertaking. the important consideration is what works, not whether the proposal is consistent with the policy maker's a priori ideological beliefs. furthermore, in designing a workable system, the 2000 whr warns of the dangers of institutional fragmentation98 and stresses a countervailing need to seek institutional coherence,99 or what can also be thought of as intrasystem rationality. 100 at the same time, policy makers need to be modest. few projects will work strictly according to plan. consequently, the capacity for learning and adaptation must be built into the process, sometimes by consciously affording discretion to front-line agents to make changes and alterations as events unfold.101 the 2000 whr warrants careful reevaluation by those seeking posi­ tive synergies between ghis and hsd. the following is intended to simply suggest some of the lessons that need to be reclaimed. first, incentives 94. 2000 who, supra note 88, at 61 (arguing for the need to separate the what from the how). 95. !d. at 45 (providing illustrations of how entire health systems can be organized within a single, integrated governmental organization, to systems with substantial vertical · segmentation, to highly decentralized systems); see also id. at 63 ("health services, like many other forms of production, can be implemented in more dispersed or more concentrat­ ed configurations, or in hybrid arrangements that combine some concentrated with some· dispersed elements."). 96. id at 61 ("both among and within countries there are marked differences in all these features, reflecting the complexity of the production process for health interventions and the variations in culture and tradition."). 97. !d. at 63. 98. !d. at 68, 120 (discussing the dangers of fragmentation). 99. id. at 66, 108, 110, 112 (discussing the importance of coherence and consistency in structural design). 100. peter j. hammer, arrow's analysis of social institutions: entering the market­ place with giving hands?, 26 j. realm pol. pol'v & l. 1081, 1095 (2001) (discussing the importance of intrasystem rationality); peter j. hammer, competition and quality as dy­ namic processes in the balkons of american health care, 31 j. realm pol. pol'y & l. (special issue) 473, 474 (2006) (same). 101. 2000 whr, supra note 88, at 64 (one must "balance the need for broad policy oversight with sufficient flexibility so that managers and providers can innovate and adapt policies to local needs and contexts in adynamic way."). 590 indiana health law review [vol. 9:2 matter and actors will systematically respond to them. different organiza­ tional structures create different types of incentives. in coherent systems, structures, incentives and objectives align in complementary directions.102 in dysfunctional systems, they do not. similarly, policy makers need to be sensitive to the transaction costs associated with different alternatives.103 in this setting, nothing can be taken for granted. governance· (stewardship) not only matters, it comes at a cost.104 those costs should be expressly con­ sidered and built into the system. the same can be said for information. 105 in addition, agents and institutions will act strategically in their own per­ ceived best interest. accounting for such strategic behavior and taking ap­ propriate counter-measures must be part of the initial and ongoing planning process.106 like a good chess player, policy makers must be thinking many moves ahead of the game. these considerations are illustrated at length in the 2000 whr 's dis­ cussion of organizational form as it relates to the function of service deliv­ ery.107 in 1937, ronald coase demonstrated how the same economic functions could be performed by a range of different private organizational forms, ranging from firms to contracts to markets.108 there is a public ana­ logue to coase's theory of the firm. the sanie public function can be per­ formed by different organizational forms. here the· continuum starts with the direct provision of services by the state, then moves to various forms of quasi-public and non-governmental service provision and ends with the provision of services by private markets.109 which organizational form is best depends upon a careful. context-specific exercise of comparative insti­ tutional analysis. "each of these ways to organize health services has its strengths and weaknesses in various contexts and when applied to different types of population-based and clinical services."uo the objective is to identify the dimensions upon which the organizational forms vary and as­ sess what combinations of factors are most important for the underlying policy objectives. for example, one consideration is the affect that organizational forms 102. id. at 69. 103. id at 104 (discussing the role of transaction costs). 104. id at 126. 105. id at 129. 106. id at xvi (discussing how experiments with contracting and decentralization·can trigger behavioral changes that must be accounted for in the planning process). 107. id. at 63--68. 108. ronald coase, the nature of the firm, 4 economica 386 (1937). 109. 2000 whr, supra note 88, at 62 ("health services can be organized in three fun­ damentally different ways-via hierarchical bureaucracies, through long-term contractual arrangements under some degree of nonmarket control, and as direct, short-t!rm market­ based interactions between patients and providers. these arrangements are independent of whether ownership is public or private."). 110. id. at 62. 2012] global health quest for positive synergies 591 can have on incentives.111 to illustrate, the 2000 whr identifies five types of incentives and examines how a range of different organizational forms map on to each of the relevant incentive components. 112 this type of analy­ sis begins to establish a fairly sophisticated framework to assess the strengths and weaknesses of different organizational forms. 113 it is im­ portant to remember, however, that no system is perfect. it is likely that some organizational forms will rate high on some dimensions and not oth­ ers. comparative institutional analysis often serves to highlight the type of stark policy tradeoffs entailed in choosing between different organizational forms. the report continually stresses the importance of designing organi­ zational foj,111s of health service delivery that maintain appropriate levels of coherence114 and avoid the dangers offragmentation.115 the 2000 whr aptly illustrates the tools and tactics of institutional economics as applied to the cause ofhsd. these techniques and methods have been lost in. the international discourse and need to be reclaimed. 111. id. at65. 112. id. at 66 fig. 3.4. the incentives examined include: (1) degree of autonomy (deci­ sion rights); (2) degree of accountability; (3) degree of market exposure; (4) degree of finan­ cial responsibility and (5) degree of unfunded mandates. ld. at 65. the range of organizational forms being considered includes: (1) bureaucratic units; (2) contracted units; and (3) market units. ld. at 66 fig. 3.4. 113. the report engages in a similar detailed institutional economic assessment of the financing building block. the same function (financing) can be accomplished by a range of different organizational forms. again, the what can be separated from the how. some of the different organizational forms include centralized state control through the ministry of health with financing through general tax revenue, to social security type organizations with mandatory work-based contributions, to private health insurance markets. i d. at 108. each of these organizational forms is associated with a different set of strengths and weaknesses. the exercise of comparative institutional analysis entails a mapping exercise of the different organizational forms with the range of factors policy makers deem most relevant to obtain~ ing their objectives. id. at 111-12 (table 5.4 and 5.5). · i d. i d. 114. id. at 66. the coherence of organizational incentives is especially important in the hospital sector because of the central role of these organizations in ser­ vice provision. countries that have introduced consistent objectives and that have aligned the five organizational incentives appear to have been more successful than countries that have ended up with conflicting ob­ jectives and incentives regimes. 115. id. at 68. as organizational units like hospitals or clinics become more autono­ mous, the service delivery system is at risk of becoming fragmented. fragmentation may occur among similar provider configurations (hospi­ tals, ambulatory clinics, or public health programmes) or between differ­ ent levels of care. such fragmentation has negative consequences for both the efficiency and the equity of the referral system unless explicit policies are introduced to ensure some sort of integration among the re­ sulting semi-autonomous service delivery units. 592 indiana health law review [vol. 9:2 they will be instrumental in addressing the "content-specific" aspects ofthe psc challenge as we move forward and fill in an important missing part of the building-block-plus framework. b. a team no more: differences between the world bank and who what was the fate of the 2000 whr when the team of rivals decamped and returned to their home institutions? in 2007, the world bank and the who separately produced reports where health systems and hsd played critical roles. the world bank published its hnp sector paper, health de­ velopment.116 the who published everybody's business.111 this section focuses on how each of these reports addresses the conceptual framework forhsdy 8 it is telling how much the 2000 whr influences the world bank's 2007 sector paper. there is strong intellectual continuity between the two documents, partly due to overlapping personnel. the leader of the healthy development team was also part of the group that generated the 2000 whr. 119 substantively, health systems and the importance of hsd assume central roles in the bank's sector strategy. "'strengthening health systems' may sound abstract and less important than specific-disease control tech­ nology or increased international financing to many people concerned about achieving hnp results. but well-organized and sustainable health systems are necessary to achieve results."120 these and other sentiments expressed in healthy development resonate strongly with what would become core components ofpsc.121 how does the bank understand what a health system is and how it op­ erates? healthy development imports the four-function approach of the 2080 whr. "these key functions are: health services delivery, resource (input) generation (e.g., human resource training, and generation of techno­ logical knowledge for disease control, pharmaceuticals, and medical equipment), and system oversight (stewardship)."122 unfortunately, alt­ hough themes of institutional economics implicitly emerge in the discussion of certain issues, such as health care finance, 123 an express reliance on the 116. 2007 healthy development, supra note 9. 117. 2007 everybody's business, supra note 9. 118. aspects of the external political environment in which these reports were generated will be examined, in part n when the global fund's experience with hsd is addressed. 119. 2000 whr, supra note 88, at ii; 2007 healthy development, supra note 9, at 8. 120. 2007 healthy development, supra note 9, at 14. 121. id at 25 (''there is now consensus that, for the renewed commitments of client countries and the international community to realize their full potential, synergy must be ensured between efforts to strengthen the health system and a focus on priority-disease re­ sults in lics."). not smprisingly, hsd assumes an important role in the world bank's new "strategic directions" outlined in the report. /d at 31. 122. id at 45. 123. /dat51,170. 2012] gwbal heal til quest for positive synergies 593 tools of institutional economics as a means of in-depth, context-specific analysis is missing from the 2007 report.124 healthy development makes two important contributions to the conceptual framework for hsd. the ftrst is to begin to model the health sector as a complex adaptive system. the second is to begin to view hsd in terms of an increasingly disaggre­ gated and stratified framework, where notions of institutional comparative advantage and division of labor can be applied to facilitate more effective cooperation. annex l of healthy development is devoted to the question ''what is a health system?"125 "a 'system' can be understood as an arrangement of parts and their interconnections that come together for a purpose. "126 the paper then explores the complexity of health systems. each of the building blocks can be understood as a sub-system within the larger health system. moreover, the health system itself is influenced by factors external to it.127 the paper proceeds to classify health systems as "open," "complex" and "adaptive. "128 given the purpose, scale, and scope of a country's health system, it is not effectively controlled central­ ly, and changes in a system are not predictable in great detail (even if some parts of the system appear to behave predictably). this is partly because people and organizations innovate, learn, and adapt to change and partly because reorganization occurs continually in health systems in both formal and informal ways.129 like opening pandora's box, this raises difficult challenges.130 neverthe124. see id. at 14. healthy development does, however, maintain many of the sensibili­ ties of the institutional economic approach. stressing the interconnectedness of the building blocks and dynamic concerns. "[i]n practical terms,'' hsd "means putting together the right chain of events (financing, regulatory framework for private-public collaboration, govern­ ance, insurance, logistics, provider payment and incentive mechanisms, information, well­ trained personnel, basic infrastructure, and supplies) to ensure equitable access to effective hnp interventions and a continuum of care to save and improve people's lives." id. in this assessment, it is the sequencing and chain of events that matter. 125. id. at 168-71. 126. id. at 168. 127. id. at 167 ("many factors outside the health system influence people's health, such as poverty, education, infrastructure, and the broader social and political environment."). 128. id. 129. id 130. a building-block-orientation without an appreciation of complexity can lead to unintended and counterproductive results. "in adaptive systems, optimizing one part of the system may lead to poor overall system performance." id at 171. health care presents a web of complex interrelationships. "adaptive systems, on the other hand. have the freedom to respond to different stimuli in different and unpredictable ways and are interconnected with the actions of other parts of a system." id. at 170-71. complexity is also a reminder of 594 indiana heal til law review [vol. 9:2 less, policy makers must begin to pragmatically accommodate the complex . nature of health systems in their planning, without becoming distracted or · . overwhelmed by it.m healthy development's second contribution is to advance a frame­ work for hsd that is increasingly stratified and disaggregated.132 the pa­ per envisions "a collaborative division of.labor with global partners along each organization's comparative adva:ntages.''133 to this end, the paper in­ troduces a new taxonomy of "main health system functions, system activi­ ties, and other determinants of system performance.''134 this taxonomy should be viewed as complimentary to and not a substitute for the building block framework. while neither elegant nor comprehensive, these main · . health system functions identified by the bank are as follows: (a) health fiilancing;135 (b) fiduciary, logistical, and financial management arrangements of the system; (c) . system gove~ance; 136 the importance of context .. "systems exist within systems, and this context niatters, because one part of a system affects another." id. at 171. finally, complexity complicates and there­ fore limits the role of prediction. i d. forecasting and modeling iii health systems can be done to predict ef­ fects on health and poverty, but they are not predictable in detail because the elements and relationships are changeabie and nonlinear, often in creative ways. ·the only way to know what complex adaptive systems will do is to observe them. 131. id. at 168. we will return to healthy development's assessment of the implica­ tions of complexity for policymaking in the next section where the ahpsr's report on sys­ tems thinking for health system strengthening is examined. 132. this analysis was not done in isolation. the bank's work is a direct response to the 2005 paris declaration's call for greater harmonization and the global task team final report's call for a more conscious awareness of the wlderlying comparative advantages of different international organizations as a basis of more rational divisions oflabor. unaids, global task team on improving aids coordination among multilateral instirotions and international donors, final report (2005), available at http://data. wlaids.orglpublications/irc-pub06/jc1125-globaltaskteamreport_ en.pdf. 133. 2007healtiiydevelopment, supranote9, at46. 134. id 135. id ("fwlding policy (level, source, fiscal space); risk-pooling organization (health insurance); insurance regulation; health service purchasing and provider payment mecha­ nisms; design of financing incentive framework for efficient allocation of r&d and human resources ... ). id 136. id at46. accountability arrangements for providers, insurers, and government in health care investments; regulatory framework for private-public collab­ oration in the health sector; decisions on delegation of decision rights and market exposure for public providers; fiduciary arrangements for fiscal resource management in the public and private sectors; linkage of specific hnp sector reforms to cross-sectoral public sector reforms (e.g., civil service reforms to attract practitioners into rural areas). 2012] global health quest for positive synergies 595 (d) positively influencing household demand for effective hnp interventions;137 (e) stewardship (sector oversight);138 (f) organization and management ofproviders;139 (g) technical aspects of disease control; (h) human resource training and creation of medical technologies and advances; 140 and (i) clinical and field research on disease control intervention effec­ tiveness and clinical protocols.141 this taxonomy is not intended to be definitive. what is important is that the typology starts to move beyond simple calls for greater "harmoniza­ tion" and categorical approaches to building blocks. in this process, the taxonomy starts to recognize the multiple distinct levels and combination of functions needed to connect the-global-to-the-national-to-the-local, as well as the highly differentiated nature of the health system itself. for effective planning, harmonization and cooperation to take place, there will need to be an increasingly stratified and differentiated understanding of the gills/hsd interface. once this threshold is passed, basic notions of authentic compar­ ative advantage and divisions of labor will provide appropriate sets of intui­ tions about how cooperation and harmonization might best proceed. the who's 2007 report everybody's business, provides a window in­ to the influence of the 2000 whr on subsequent who thinking about health systems. everybody's business is a slick, nicely produced document that persuasively presents the who's belief in the importance ofhsd and advocates for future change.142 it is certainly more reader friendly than healthy development. while the 2000 whr is a document clearly written by economists, everybody's business is a document that clearly was not. not surprisingly then, the report reveals very little advancement in the who's substantive understanding of health systems in the seven years since the publication of the 2000 whr. the four functions (building blocks) have cosmetically evolved into six building blocks, but little else has changed. indeed, many understandings have atrophied and appeared to 137. id ("demand-side interventions (such as conditional cash transfers, girls' educa­ tion, community~driven development, and voice and choice reforms in health service deliv­ ery)."). 138. jd ("overall sector leadership; sectoral strategic planning; provider regulation; inputs and health service quality control; epidemiological surveillance; identification of health priorities for setting mandatory basic benefits packages."). 139. !d. at 47 ("how to run a clinic, hospital, or provider network; organizing village volunteers; organizing ngo or private for-profit health service delivery."). 140. id. ("human resources; r&d and manufacturing of drugs and supplies (beyond contributing to global financing and incentives for development and production of orphan drugs); r&d and generation of medical technology."). 141. !d. ("defining effective production functions; testing them in the field."). 142. see 2007 everybody's business, supra note 9. 596 indiana health law review [vol. 9:2 have been forgotten. in the 2000 whr, health system functions (building blocks) were separated from organizational form as part of a larger institu­ tional economic argument that deepened the context-specific understanding of health systems.143 this perspective is largely absent in subsequent who publications.144 everybody's business makes the obligatory admonitions that the building blocks cannot be viewed in isolation and that interrelation­ ships between the blocks are important, 145 but the report offers very little in terms of suggesting how one could begin to understanding these dynamic interrelationships. that said, everybody's business contains a number of positive attrib­ utes. more than a group of economists would appreciate the who recog­ nizes the significance of the political and social dimensions of health systems. hsd "requires both technical and political knowledge and ac­ tion."146 this is an important reminder, even for institutional economists who are more open to such concerns than their neoclassical colleagues. "this means health system strengthening requires careful judgment and hard choices. it can be better informed by evidence and by the use of tech­ nical tools, but ultimately it is a political process and reflects societal val­ ues. "147 as such, these processes are best served by ongoing · interdisciplinary dialogue. this is perhaps what was really missing between 2000 and 2007. in the end, the power of the 2000 whr was not the pres­ ence of world bank economists, but the diverse disciplinaty and institu­ tional makeup of its group authorship. fortunately, this ground is reclaimed inpsc.148 143. see discussion supra notes 92-101 and accompanying notes. 144. there is another difference between the 2000 whr and 2007 everybody's busi­ ness reports. rather than advancing economic understanding of health systems, 2007 every­ body's business tries to re-ftame the issue of health systems and hsd within the context of the primary health care movement and the declaration of alma ata. 2007 everybody's business. supra note 9, at 2 ('"the directions set out for who in this document are deter­ . mined by the values and goals enshrined in the alma ata declaration. j; see also id at 5 (box: "what can we learn from the primary health care values and approach?"). this con­ nection is made even stronger in world hea.lrn org., the world hea.lrn report 2008: prlmary hea.lrn care: now more than ever xv, 26 (box 2.1 ), 64 (2008), available at http://www.who.int/whr/2008/whr08_en.pdf. discussion of the wisdom of linking the ghls!hsd agenda with that of alma ata and primary hetdth care will be addressed in part vi of this article. 145. 2007 everybody's business, supra note 9, at v ("while the building blocks pro­ vide a useful way of clarifying essential functions, the challenges facing countries rarely manifest themselves in this way. rather, they require a more integrated response that recog­ nizes the inter-dependence of each part of the health system.''); see also id. at 4 ("a health system. like any other system, is a set of inter-connected parts that must function together to be effective. changes in one area have repercussions elsewhere. improvements in one area cannot be achieved without contributions from the others. interaction between building blocks is essential for achieving better health outcomes.''). 146. id. 147. id at7. 148. the who's everybody's business and the world bank's healthy development 2012] global health quest for positive synergies 597 c. confronting complexity: an introduction to systems thinking the who's psc has made important progress toward improving our conceptual understanding of health systems and hsd. this progress con­ tinues. health systems are '"complex, context-specific and changing."149 the institutional economic approach of the 2000 whr provides guidance on better understanding context-specificity through the tools of institutional economics. the 2007 healthy development paper begins to address the challenge of complexity. the understanding of interconnectedness and complexity is further advanced by the alliance for health policy and sys­ tems research's 2009 report, systems thinkingfor health system strength­ ening (systems thinking). 150 readers are likely to be intimidated by the concept of complexity. in­ deed, the report eschews the term as much as possible, using the rhetoric of "systems" and "systems thinking" rather than the more common references in the literature of complex adaptive systems.151 the report examines what complex systems are and how these characteristics improve our understand­ ing of health systems. properly understood, the logic of complexity is actu­ ally a call for modesty and simplicity. it is a rejection of elaborate meta­ plans in favor of more simple, process-oriented methods of policy for­ mation and implementation. to that end, systems thinking outlines a rela­ tively straightforward ten-step process of policy design and evaluation.152 why is system thinking important in trying to understand health sys­ tems? even the most well-intentioned intervention is likely to fail unless broader systemic implications are taken into account in the design and im­ plementation of the undertakings.153 this has the potential to pile up unin­ tended failure after unintended failure, with these failed interventions embody some important commonalities. both reports acknowledge the lack of a complete understanding of health systems, as well as the need to improve monitoring and evaluation in a manner that facilitates learning and new understanding. healthy development, supra note 9, at 54-55; everybody's business, supra note 9, at 24, 31. both reports are frank about serious weaknesses within each institution in their capacity for effective future action given the complex challenges of hsd. healthy development, supra note 9, at 30; shakow, supra note 9, at 9; everybody's business, supra note 9, at vi, 24, 26-27. both reports outline sets of internal reforms and changes that would be necessary to better enable the respective institutions to undertake future work in the area. healthy development, supra note 9, at 54, 59; sbakow, supra note 9, at 10, 55-56; everybody's business, supra note 9, at 28-30; 35-37. these are honest and fair assessments. as psc makes clear, sub­ stantial changes within every international organization and ghi will be required to make sustained progress in developing positive synergies. 149. psg lancet article, supra note 6, at 2140. 150. see generally systems thinking, supra note 89. 151. id at 40 n.2 ("our definition of 'system' is described in the literature as a 'com­ plex adaptive system' -one that self-organizes, adapts and evolves with time. 'complexity' arises from a system's interconnected parts, and 'adaptivity' from its ability to communicate and change based on experience."). 152. !d. at 54 (box 3.2). 153. id at 19 ("within such unmapped and misunderstood systems, interventions­ even the very simplest-often fail to achieve their goals."). 598 indiana health law review [vol. 9:2 themselves, becoming obstacles to future actions.1s4 the hope is that plan­ ning undertaken from a system's perspective will have a greater chance of success. tss what then is "systems thinking?"1s6 systems thinking is an approach to problem solving that views 'problems' as part of a wider, dynamic sys­ tem. systems thinking involves much more than a re­ action to present outcomes or events. it demands a deeper understanding of the linkages, relationships, interactions and behaviours among the elements that characterize the entire system. 1s7 the foil to systems thinking is what the report terms the "input-blackbox­ output paradigm." ''the systems thinking approach goes beyond this 'in­ put-blackbox-output' paradigm to one that considers inputs, outputs, initial, intermediate and eventual outcomes, and feedback, processes, flows, con­ trol and contexts."158 this is a challenge to much of mainstream social sci­ ence, including neoclassical economics, which treats the firm, the market and the state largely as content-less black boxes. how does this approach relate to the building block orientation that 154. id at 51 ('"a systems perspective can minimize the mess; many oftoday's prob­ lems are because of yesterday's solutions."; (internal quotation marks omitted) (quoting dr. irene akua agyepong, ghana health service ministry ofhealth (2009))). id 155. id. at 19. if we accept that no intervention is simple, and that every act of interven­ ing has effects-intended and unintended-across the system, then it is imperative that we begin to understand the full range of those effects in order to mitigate any negative behaviour and to amplify any possible synergies. we must know the system in order to strengthen it-and from that base we can design better interventions and evaluations, for both health systems strengthening interventions ·and for interventions targeting specific diseases or conditions but with the potential of having system-wide effects. 156. a classic swiss watch or an automobile engine is a complex system, but not an adaptive one. systems thinking lists eight characteristics that are common to complex adap­ tive systems. by understanding these characteristics, one begins to develop a set of intui­ tions for dealing with complex systems. complex adaptive systems are: 1) self-organizing; 2) constantly changing; 3) tightly linked; 4) governed by feedback; 5) non-linear; 6) history dependent; 7) counter-intuitive; and 8) resistant to change. id at 40 (box 2.1 ). 157. !d. at 33. 158. !d. at 34. 2012] global health quest for positive synergies 599 lies at the center of existing conceptual frameworks for health systems? the approaches are relatively easy to meld together. systems thinking deepens the intuition of the building-block-plus framework's notion of interconnectedness. the who building blocks can be reconfigured as sub­ systems within the larger health system. systems are dynamic architectures of interactions and synergies. who's framework of health system build­ ing blocks effectively describes six sub-systems of an overall health system architecture. anticipating how an intervention might flow through, react with, and impinge on these sub-systems is crucial and forms the opportunity to apply systems thinking in a construc­ tive way.159 it must be clear, however, that the individual building blocks cannot be con­ fused with the health system itself. the building blocks alone do not constitute the sys­ tem, any more than a pile of bricks constitutes a func­ tioning building. . • . it is the multiple relationships and interactions among the blocks-how one affects and influences the others, and is in turn affected by them-that convert these blocks into a system.160 in terms of the broader conceptual framework, the report makes an­ other contribution. systems thinking stresses the role of people and com­ munities as essential plus factors. it is critical that the role of people is highlighted, not just as the centre of the system as mediators and the beneficiaries but as actors in driving the system itself. this includes their participation as individuals, civil society organizations, and stakeholder networks, and also as key actors influencing each of the building blocks, as health workers, mangers and policy­ makers.161 as complexity moves to simplicity and the elaborate formal blueprints of the past move to incremental, process-oriented planning, people and partie159. /d. at 19. 160. id. at 31. 161. id at 32. 600 indiana health law review [vol. 9:2 ipation will play central roles.162 while it is important to know what systems thinking is, it is also im­ portant to understand what systems thinking is not. systems thinking is not a promise of easy answers. "systems thinking is not a panacea. its applica­ tion does not mean that resolving problems and weaknesses will come easi­ ly or naturally or without overcoming the inertia of the established way of doing things. but it will identify, with more precision, where some of the true blockages and challenges lie.''163 it offers a new set of tools and tac­ tics. it helps chart a new direction.164 that said, it is also true that existing practices in governments, in academics and in the learned professions are strongly biased in the traditional direction. 165 advocates and policy makers likely will be confronted with significant opposition in efforts to implement new processes of systems thinking and planning. how does one make policy in the domain of complex adaptive sys­ tems? systems thinking advises asking three questions: (1) "how can we anticipate potential effects?"; (2) "how can we conceptualize the actual be­ havior of the intervention?"; and (3) ''how can we redesign a more sophisti­ cated intervention that accounts for those potential effects?"166 the report outlines a pragmatic ten-step process governing the design of the interven­ tion and its evaluation from a systemic perspective.167 substantial attention 162. this challenge is taken up again in part v of the article where the role of commu­ nity systems strengthening and civil society is examined in greater detail. 163. systems thlnkino, supra note 89, at 20. 164. table 2.1 of the report contrasts traditional approaches to understanding and policy making with a systems thinking orientation. id at 43. traditional approaches are static and focus on particular events, often in isolation. systems thinking seeks to frame problems in terms of patterns and behavior over time. traditional approaches see behavior generated by the system as exogenously driven by external forces. systems thinking is open to the reality that many aspects of the systems behavior are seu:.generated and endogenous. traditional approaches focus on the trees and specific, isolated details. systems thinking focuses on the forest and seeks to understand relationships. traditional approaches utilize straight line thinking and direct theories of causation. systems thinking encourages loop thinking and an openness to complex cycles of cause and effect playing out jointly over time. the lesson is not that one approach is good and the other is bad. the lesson is that the orientation must be correctly mapped onto the nature of the problem. different problems require different ap­ proaches. !d. 165. the concept of "non-linearity" can be particularly difficult for traditional policy makers to comprehend and appreciate in practice. "{r]elations within a system cannot be arranged along a simple input-output line. system-level interventions are typically non­ linear and unpredictable, with their effects often disproportional or distantly related to the original actions and interactions." !d. at 41. trying to absorb and incorporate all of these considerations requires a change in traditional frames of thinking. it will be argued in the next section that the global fund's failure to make effective progress in hsd can be at­ tributed, in part, to its failure to approach the problem ofhsd from a systemic perspective. 166. id at 51. 167. id at 20, 54. the ten-step process is as follows: i: "intervention design 1. convene stakeholders 2. collectively brainstorm 3. conceptualize effects 2012] global health quest for positive synergies 601 must be paid to the design phase. the convening of stakeholders and col­ lective brainstorming are indicative of process-oriented methods to incorpo­ rate the plus factor of people and participation.168 this process must be open and inclusive to be effective. 169 ideally, the collective brainstorming process will identity a range of potential implications (traditionally unfore­ seen?), triggered by the interventions' impact on other parts of the system. in what should become an ongoing pattern of adaptation and course adjust­ ments, there is the possibility to redesign the intervention in light of these concerns even before it is slated for implementation. the design phase focuses not only on the structure of the intervention, but on how that intervention will be evaluated once implemented. this is innovative for a number of reasons. oftentimes policies having system­ wide effects are designed and implemented without any efforts at ex post evaluations. if evaluations are undertaken, it may only be as an after­ thought. evaluations conceived of after the intervention has been designed and implemented are seriously constrained in the types of methods they can employ and the data that can be collected. building considerations of eval­ uation into the design process itself is reflective of an attuned, systems thinking orientation that will not only improve the design itself, but will also make for more innovative and effective forms of evaluation. because the focus of the ten-steps is on the design phase, inclusive of planning for evaluations, it does not expressly examine what should be done with the information collected from the evaluations. the logic of sys­ tems thinking makes the answer to this question obvious. there has to be a feedback mechanism built into the policy making and implementation pro­ cess itself, where the results of the evaluations can lead to changes in the design and implementation of the intervention. planning is not an event that ends with design and implementation. planning must become an ongo4. adapt and redesign ii: evaluation design 5. detennine indicators 6. choose methods 7. select design 8. develop plan and timeline 9. set a budget 10. source funding." id. at 54 (box 3.2). this is just one of many possible ways one could envision policy mak­ ing in the context of complexity, but it serves as a useful illustration. rigid concepts and templates are to be avoided. "these steps are less an exact and rigid blueprint and more a conceptualized process. they are flexible and may be adapted to many different situations and possibilities." id. at 54. 168. shifting to a process orientation and incorporating greater stakeholder participation can help make the transition to systems thinking self-sustaining. systems thinking, supra note 89, at 74 ("health system stewards can use the systems thinking perspective to increase local ownership of multi-stakeholder processes and respond to the dynamic of dis­ ease-specific, sometimes donor-driven 'solutions."'). 169. id. at 55 ("at a minimum, at least one knowledgeable representative of each sub­ system (or building block) is required, plus at least one representative of the research com­ munity and one from a funding partner."). 602 indiana health law review [vol. 9:2 ing process with multiple structured occasions for learning, adaptation and change. in what must become a mantra on systems thinking analysis, eval­ uation must be the first step of a larger process oflearning and adaptation. is any of this practical in the real world? "[m]any practitioners still tend to dismiss it as too complicated or unsuited for any practical purpose or application."170 this is an important concern to address. ironically, the primary challenges in implementing systems thinking may stem not from the complexity of the approach, but rather from the difficulties in changing the mindsets of traditional policy mak:ers.l71 it is important to draw the cor­ rect lessons from complexity. the world bank paper healthy development is useful in this regard. ·recognizing complexity is not a call for drawing up and more and more elaborate and detailed plans. this is the fundamental error of mechanistic thinking. a true appreciation of complexity calls for greater simplicity in initial planning, a dramatic change in the processes of policy implementation, a greater use of heuristics in. guiding decision­ making and a commitment to learning and adaption through time. what are the practical implications of viewing health systems as complex adaptive rather than n'lechanical systems? in the first place, giving up a mechanical approach means spending less time on blueprints and detailed plans. it also means tbiu it is less important to search for the "correcf' he8lth financing or organi­ zational approach for a given country or a given con­ text.172 170. id. at 75. 171. id (''the first of the 'fundamental impediments' to the adoption of systems think­ ing is that we're prisoners of our frame of reference.") (quoting barry richmond, systems thinking: four key questions.~02 (1991)). 172. 200711ealtiiy development, supra note 9, at 170. healthy development outlines a number of common sense lessons for future hsd initiatives: • understand the context, look for connections between the parts (e.g., between programs, between demand and supply, across sectors), anticipating downstream consequences and identifying upstream points of leverage. • focus on simple rules to produce complex outcomes. balance three types of rules that: (1) set direction (e.g., leadership and vision); (2) set prohibitions (e.g., regulations and boundary setting); (3) provide permission (e.g., setting incentives or providing resources). • understand how organizational structure influences behavior. how ministries are organized, and how development assistance is pro­ vided matter a great. deal. health workers hired and trained under a cen­ trally managed disease program will work differently from those accountable for all outpatient conditions and hired by a local health ser­ vice organization. • use data to guide decisions. constantly looking at how health systems perform is the best way to see how it is actually behaving and whether a project or.new intervention is making a difference. 2012] global heal til quest for positive synergies 603 an incremental, process-oriented approach to hsd is likely to be less frus­ trating and less complicated than approaching hsd using existing tools and temperaments.173 iv. administrative challenges-the gwbal fund's experience with health systems this may be the most important section in the article, because it high­ lights the serious, but often underappreciated administrative challenges that can prevent ghis from achieving positive synergies in practice. it is not enough for sophisticated, well;..intentioned organizations to make official commitments to hsd. indeed, the need to address disease specific inter­ ventions in a manner that constructively engages health systems is express­ ly recognized in the global fund's framework docume'nt.114 nevertheless, the fund's experience with hsd has been far from an unmitigated success. ultimate success requires a ghi to make hsd a real institutional priority. it further requires a workable theoretical framework for hsd capable of· informing the mundane administrative tasks that guide actions inside a large bureaucracy. countries submitting applications have to know what types of proposals are viable. ghi administrators drafting application forms, writ­ ing guidelines and reviewing proposals have to understand how health sys­ tems function. they must eschew rigid, linear understandings of causation as they relate to positive synergies and embrace the broader notions of mul­ tiple and indirect forms of causation associated with systems thinking. fi­ nally, the ghi itself must maintain receptivity to learning and adaptation in light of its own experiences. to make all these elements coalesce within a complicated bureaucratic structure is not an easy task, but this is the essence of the administrative challenges. a careful case study of the global fund permits us to take a long view of the relatively young field ghi experience with hsd. the global fund · has been wrestling with these issues for nearly a decade. the story of the global fund's work is best told in three chronological chapters. between 2002 and 2010, the global fund issued ten rounds of calls for proposals. hsd in rounds 1-4 (2002-2004) lacked both coherent direction and any identifiable results. this era also marked the beginnings of external com­ plaints about the potential harmful impacts the global fund and other ghis had on hsd. rounds 5-7 (2005-2007) were periods of experimentation, /d. at 170. one can see the many parallels between this advice and the 1 0-step process for designing interactions and evaluations in systems thinking. 173. no one person bas to master all aspects of a complex system. the necessary col­ lective knowledge and collective understanding can be created by convening the right sets of stakeholder groups. 174. framework document, global fund to fight aids, tuberculosis and malaria § iv: scope (f)(l) (2002) [hereinafter framework document], available at http://www.theglobalfund.orgldocuments/corelframework/core _ globalfund _framework_ en /. 604 indiana health law review [vol. 9:2 consultation but ultimate retrenchment. rather than aiming to help build health systems, round 7 called for the demonstration that global fund pro­ jects would at least do no harm to existing structures. rounds 8-10 (20082010) began to demonstrate slow progress and the evolution of new stand­ ards in the grant making process that should place the fund in a construc­ tive. position to partner with future psc efforts. the case study also highlights how the "political," "theoretical," and "administrative" challeng­ es discussed throughout this article unavoidably overlap, in practice, in the quest for positive synergies. a. rounds 1-4 (2002-2004): is there any real there, there for health systems? getting the global fund up and running was a tremendous task and no one should expect perfection in such an undertaking. unfortunately, one area that was neglected in the early years was hsd. this is surprising, be­ cause it was understood at the global fund's inception that hsd was essen­ tial to public health and that no sustainable progress could be made against hiv i aids, tuberculosis and malaria, without an effective public health in­ frastructure. the global fund framework document commits the fund to support programs that "[a ]dress the three diseases in ways that will contrib­ ute to strengthening health systems."m the "core principles" of the framework document further commit the fund to support interventions against these three diseases in an manner that will "strengthen systems for working[] within the health sector; across government departments; and within communities."176 why then did the global fund get off to such an inauspicious start? the fund has completed a number of internal evaluations of its early expe­ rience and is honest about its difficulties in addressing hsd.177 the global fund's five-year evaluation cites the lack of external guidance and con­ ceptual frameworks as one of the explanations for its initial poor perfor­ mance. ''the collective findings on health systems must also be placed within a broader information context that includes a general dearth of both data and validated methods to assess health systems performance global­ ly."178 that said, the global fund could have done more with what intellec­ tual resources were at hand. tellingly, the fund's five-year evaluation 175. ld. § n: scope (f)(i). 176. id. § lll: principles (h)(3). 177. james sherry et al., the five-year evaluation of tile global fund to fight aids, tuberculosis and malaria: syntiiesis of s'iudy areas 1, 2 and 3 (2009) [hereinafter five-year evaluation]. 178. id at 22. even today, the co-construction of a more workable conceptual frame­ work is a necessary part of future action. "'lbese recent developments illustrate increasing demand for more and better assessment of health systems performance, but also an implicit recognition that necessary frameworks. data systems, and methods are not yet in place." id 2012] global health quest for positive synergies 605 arguably misidentifies the date of origin of the who's building block framework. "the who conceptual framework that identifies the six build­ ing blocks of health systems is quite recent (2007)," citing the who's re­ port everybody's business. 179 once again, the 2000 whr is the forgotten stepchild. it is true that everybody's business cosmetically refined the pre­ vious four building blocks (functions) ofthe 2000 wrh, but the core of the idea clearly lay in the earlier document. this is significant because it means that the substantial intellectual resource of the 2000 whr was available at the 2002launching of the global fund. the real truth is that despite commitments in its framework docu­ ment, hsd was simply not a high priority for the fund in the early years. hsd "was not a first-order preoccupation at the time."180 the global fund mistakenly believed that hsd would somehow take care of itself with the simple increase in spending on hiv i aids, tuberculosis and malaria. ''the establishment of the global fund was with the expectation that strength­ ened health systems (including health information systems) . would be an almost inevitable consequence of increased health sector spending."181 this ethos is reflective of a strong and misguided belief in private ordering; the belief that markets and other systems will miraculously self-organize to re._ spond to social needs. even a casual reading of the 2000 whr or an appre­ ciation of its institutional economic underpinnings would have cast substantial doubt on this premise.182 effective governance structures and · well-functioning social institutions are too often the exceptions in human history, not the rule. their creation and cultivation cannot be an after­ thought left to chance.183 179. /d. 180. !d. at 12. 181. id at 11-12; see also id. at 12 ("so while strengthened health systems were broad' ly appreciated as a desirable outcome of greater levels of investment, they were not generally seen as a necessary precondition for those investments."). 182. a true understanding of the institutional economic lessons inherent in the zooo whr-lessons lost on the who itself-would have helped the global fund avoid the mis­ take of not prioritizing hsd and wrongly believing that hsd could somehow take care of. itself. 183. the global fund's retrospective assessment is consistent with contemporaneous documents of the time. while the absence of evidence of careful global fund thinking about · hsd is not necessarily evidence of absence, one cannot help but be disappointed with the global fund's early work product. in 2005, the fund published a document, measuring tile system effects of tile gwbal fund wrrn a focus on addmonalily, p ar1nerships and sustainability. gwbal fund to fight aids, tubercuwsls and malaria, measuring the system effects of tile gwbal fund wrrn a focus on addmonalily, par1nerships and sustainabilily (2005). thinking about domestic health systems piays at best a very minor role in the report. the standard international phrase and acronym, health system strengthening ("hss"), does not even merit an entry on the list of abbrevia­ tions used. this is true despite the fact that the ostensive purpose of the report was to ''better define measurements of the systems effects of{the global fund's] activities." /d. at 5. the factors of additionality, partnerships and sustainability are critical and remain so for future· system-wide action, but hsd is critical as well. the absence of a focus on health system 606 indiana health law review [vol. 9:2 what fills the void of a working conceptual framework for health sys­ tems and a strong commitment to hsd in the early grant making rounds? the answer is in the bureaucratic logic of the global fund process itself. guidelines must be written. application forms must be drafted, filled out and reviewed. just as the 2000 whr is a document clearly written by a particular brand of economists, the stamp of bureaucrats and lawyers clearly marks the global fund's initial efforts to define and implement criteria for hsd. this is a dangerous setting where lengthy and complicated forms can and did trump substance. the global fund's ostensive objective was to draft a set of administra­ tive materials that were consistent with its framework document. the framework document commits the global fund to support programs that "[a ]ddress the three diseases in ways that will contribute to strengthening health systems."184 this language was interpreted-and it is an act of inter­ pretation-to require a clear link between any proposal for hsd and one of the three targeted diseases. but, this proposition too requires further inter­ pretation. what does it mean for a proposal to be "linked" to one of the three diseases? here, the lack of a conceptual framework for hsd becomes critical. notions of linkages and causation should be derived from defensi­ ble theories about what health systems are and how hsd can best be ac­ complished. rather than drawing from lessons of systems thinking with multiple and indirect forms of causation and layers of interconnectedness, the fund reverted to mechanistic, linear modes of thinking and causation. in the wrong setting, these assumptions can be misguided, wrongheaded and even dangerous. such standards will almost unavoidably generate a poor set of hsd proposals that will be considered by an increasingly frus­ trated technical review panel. keeping these dynamics in mind helps ex­ plain much of what is disappointing about the global fund's early experience with hsd. to say that the framework document raises issues of interpretation is not to deny that there are difficulties inherent in trying to square the circle of ghis and hsd. recognition of the critical role of health systems in supporting service delivery gives rise to a complex challenge: how should funding agents such as the gf best target their resources in order to build stronger health systems while retaining a primary focus upon development in this report is in line with the admission that health systems were simply not "a first-order preoccupation at the time." five-year evaluation, supra note 177, at 12. the importance of health systems was only hinted at in the 2005 report. the report makes no effort to define health systems or to develop or discuss potential conceptual frameworks. tellingly, there is no citation to, nor discussion of the who's 2000 wrh. 184. framework document, supra note 174, at§ n: scope (f)(l); see also id. § iii: principles (h)(3). 2012] global health quest for positive synergies 607 ,the diseases which constitute their core mandate?185 this is not an easy task. "according to guidelines for round 1, a proposal 'may include interventions to improve national capacity associated with the delivery and monitoring of programmes but should not have capacity build­ ing as its main focus. "'186 the phraseology in round 3 was slightly more accommodating to hsd, but still required a direct connection between hsd and the covered diseases. "a proposal must address one or more of the three diseases (hn/aids, tuberculosis, or malaria) and may also address system-wide/cross-cutting aspects of these diseases in ways that will con­ tribute to strengthening health systems. "187 according to the global fund, hsd work and the specific diseases must be linked. round 1 guidelines "state any proposed actions must be shown to be linked to achievement of clear, measurable and sustainable hn aids, tb and malaria outputs and outcomes."188 this is contrary to the teachings of complex adaptive systems. requiring direct notions of causation that will produce measurable outcomes with a short timeframe, ultimately rules out a wide-range of legitimate hsd initiatives that would in fact make the global fund's work in hn/aids, tuberculosis and malaria more effective. workforce investments provide one illustration of the prob­ lem. [p]roposals are asked to demonstrate a direct link be­ tween spending on the health workforce and effects on the patient/target population. studies have shown ' this link at the macro level demonstrating a correla­ tion between health outcome indicators (i.e. child 185. kate stillman & sara bennett, systemwide effects of the global fund: interim findings from three country studies 1 (2005) available at http://www. theglobalfund.org/documents/library/library _ iepnadfl96 _report_ en!. the same challenge is described elsewhere as a "tightrope walk." sigrid drager eta!., health work­ force issues and the global fund to fight aids, tuberculosis and malaria: an analytical review, 4(23) hum. resources for health 1, 3 (2006), available at http://www.human­ resources-health.com/content/pd£11478-4491-4-23.pdf. "[t]he global fund has entered a kind of tightrope walk by focusing on its clearly defined goal to fight the three targeted dis­ eases, but at the same time recognizing that adequate capacity of the health system is a pre­ requisite for any successful intervention." !d. 186. drager et al., supra note 185, at 3. 187. sara bennett & alan fairbank, the system-wide effects of the global fund to fight aids, tubercuwsis and malaria: a conceptijal framework 6 (2003), available at http://www.healthsystems2020.org/files/1559 _file_ tech031_ fin. pdf (quoting global fund to fight aids, tuberculosis and malaria, guidelines for proposals 7 (2002)). ' 188. world health 0rg., the global fund strategic approach to health system strengthening: report from who to the global fund secretariat 37 (an­ nex 5) (2007) [hereinafter who-of consultation), available at http://www.who.int/ healthsystems/gf _strategic_approach_%20hs.pdf. 608 indiana health law review mortality) and the density of the health workforce. however, it is quite a different challenge to prove such a direct connection for specific interventions to invest in human resources for. health that are de­ scribed in global fund proposals. one of the main obstacles is certainly the long'time lag, which is typi­ cal for many investments for the health workforce, such as training of health professionals.189 [vol. 9:2 not surprisingly, workforce proposals faired very poorly in the early rounds of global fund review. malawi's proposal in round 1 is an im­ portant illustration. "malawi's gf proposal included comprehensive and crosscutting systems issues such as broad human resources and infrastruc­ ture development, in alignment with a broader national strategy which rec­ ognized the importance of such. issues to the implementation of activities targeted to the focal diseases."190 the rationale for the proposal was high­ lighted in the accompanying cover letter from the principal secretary for health. "priority should be given to systems strengthening in the fll'st year, so that all future expanded support from the fund can be wisely, confident­ ly and effectively directed."191 malawi's broad proposal was rejected. "unfortunately, most health system strengthening elements were removed from the scope of activities approved in the final grant agreement."192 the global fund is committed to results-oriented funding. if one judges the fund by its own standard, hsd performance in the first four rounds was very disappointing. the global fund received a total of ten applications for. all four rounds and funded only one of those ten applica­ tions.193 rounds 1-4 of the grant making process had failed to produce a workable system for identifying and encouraging proposals that contributed tohsd. [f]or the first four grant rounds, proposals were sub­ mitted under different rubrics that responded to the three focal diseases supported by the gf . . . . there 189. drager et al., supra note 185, at4 (citations omitted). 190. stillman & bennett, supra note 185, at 2. 191. id. at 3 (quoting cover letter from dr. r.b. pendame, malawi principal secretary for health, accompanying malawi's round 1 global fund proposal (mar. 2002)). 192. id 193. global fund to fight aids, tuberculosis and malaria, mid-term review of the second voluntary replenishment 200!'r-2010, progress report on health system strengthening 4 {2009) [hereinafter mid-term review 200fr-2010], available at ht1p:/lwww.goo'l).e.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad==rja&sqi=2&ved=o cd8qfjaa&uri=http%3a%2f%2fwww.theglobalfimd.org%2fdocwnentso/o2freplenishment%2 f2()()90/o2freplenishment_ 2009cacereshealtbsystemstrengtheningpros_ report_ eno/o2f&ei= everujydiqrmyqgnxih4aw&usg=afqjcng-ov _zif4usiouradpad dab­ suzjg&sig2=6b7dp3z _ eonteojpgn8kxw. 2012] global heal til quest for positive synergies lacked any guidance from the gf about what types of broader health systems strengthening-if any-could be included in proposals to the gf. thus during early rounds, many country proposals avoided health sys­ tem strengthening interventions, as it was uncertain how acceptable they were.194 609 this is clearly not what the framework document had in mind when it committed the fund to operate in a fashion that contributed to hsd. the promise of the global fund and hsd remained unfulfilled. 195 the lack of a viable conceptual framework played an important role in explaining this failure. 196 b. rounds 5-7 (2005-2007): experimentation, consultation but re­ trenchment in round 5, the global fund introduced a potentially innovating ex­ periment for hsd funding. rather than requiring hsd initiatives to be tied to specific disease proposals, the fund opened a separate window for hsd evaluation.197 this was similar to an experimental approach being intro­ duced by ga vi. 198 the change was welcomed by many as a substantial improvement in hsd strategy. "the of's recent policy shift-including health systems strengthening in its round 5 application process-appears essential to the achievement of its disease-related objectives."199 if one evaluated the substance of the underlying documents, however, the actual contents of the round 5 guidelines were not substantially different from the standards employed in the previous rounds.200 thirty applications were submitted to the round 5 hsd window. on­ ly three proposals, however, were funded, including an application from malawi to address the same workforce concerns that were the subject of their unsuccessful round 1 application?01 in light of its growing experi194. stillman & benneti, supra note 185, at 2 (emphasis in original). 195. id. at 48 ("[t]he contribution of of to health system strengthening to date appears to be small."). 196. id at 49 ("for many elements of the health system, there is no clear vision or agreed strategy for how to strengthen them-this is true both at the global and the country levels."). 197. id. at 3 ("in round 5, the of for the first time included in its call for proposals, a health systems strengthening component in addition to components addressing the three priority diseases.j. 198. who-of consultation, supra note 188, at41. 199. stillman&bennett,supranote 185, atxxi. 200. whq.gf consultation, supra note 188, at 36 (''round 5 introduced a separate 'health systems strengthening' component, to improve upon and clarify the 'integrated' component of round 4. in practice, the guideline definitions for both were very similar.''). 201. eric friedman, guide to using 1he global fund to fight aids, 610 indiana health law review [vol. 9:2 ence, the global fund's technical review panel ("trp") issued a report detailing certain deficiencies with hsd applications, as well as the global fund application process for dealing with health systems. the report in­ cluded the following criticisms: • the definition of hss proposals in the proposal form and guidelines was too vague and too broad, with little guidance to applicants on any specific focus for these proposals. • the proposal form has been designed for the disease specific components, and is largely unsuitable for the submission ofhss proposals. • there has been insufficient consideration given to the impact of inviting separate hss proposals, while insisting that there be a specific linkage to one or more of the three diseases. • applicants were not given any specific guidance on what an ef­ fective linkage between hss and a disease component should or could look like.202 the trp report concluded that the ''gfatm system is not currently set up to generate strong hss proposals, nor to evaluate these effectively."203 in light of these· problems the trp sought advice from the global fund board on the following issues: • whether to retain a separate category of hss proposals, or to re­ integrate these within disease proposals, while making it clear that disease proposals can encompass a broader range of hss elements than was previ­ ously accommodated. • whether or not hss elements are submitted separately, or within disease proposals, the precise range of hss elements that gf a tm wishes to fund should be carefully defined. • depending on the resolutions achieved on the above issues, other important issues such as appropriate ccm composition, content of proposal forms and guidelines, and trp composition, will also need to be ad­ dressed.204 in the wake of the round 5 experience, the global fund was still struggling to define the meaning of hsd in light of its framework document and was gaining very little traction. it is important to read the trp evaluation of the round 5 proposals not as a specific critique of the notion of a separate wintuberculosis and malaria to support healtii systems strengthening in round 6, 11 (2006), available at http://www.equinetafrica.org/biblldocs/friehs.pd£ 202. global fund to fight aids, tuberculosis and malaria, eleventii board meeting: report of tiie technical review panel and tiie secretariat on round five proposals 24-25 (2005) [hereinafter trp report on round five), available at http://www.who.int/hea1thsystems/gf8.pd£ 203. ld at 25. 204. jd 2012] global health quest for positive synergies 611 dow for hsd funding, but rather as a cumulative critique of the global fund's failure to find satisfactory answers to the underlying relationship between the fund and hsd over the first five rounds of its grant making process. the issues raised by the trp are not only technic3lly complicated, but they are politically charged. 205 politics play an important role within the diverse board of the global fund, as well as in the broader international public health architecture. the next two years marked a period of intrigue, external consultations and intense fighting over the global fund's role in hsd. in 2005, factions inside the global fund and the world bank com­ missioned a study of the roles that both institutions should play in the future of international hsd.206 the paper, global fund-world bank hiviaids programs comparative advantage study, was prepared by alexander shakow, a retired world bank consultant. 207 shakow was properly critical of the limitations of the fund's previous ad hoc approaches to hsd. [t]he global fund argues that about half its financing has gone to . support systems development (even be­ fore the fifth round established a special category for this purpose), but what research evidence there is suggests that relatively little disease-specific invest­ ment of this kind actually has a lasting impact on de­ livery systems, unless it is designed with that objective in mind.208 · shakow's primary conclusion, however, was that there should be a new international division of labor where the global fund would limit its activities to an express focus on the three target diseases-hn i aids, tu­ berculosis and malaria. 209 who should take broader responsibility for hsd? shakow asserted that the world bank should play the leading role.210 in practical terms, this implied that the global fund should close 205. shakow, supra note 9, at 27 {"this category was added despite the reluctance of some board members and staff who considered this a dilution of the global fund's core focus on the three diseases."). 206. crr. for global dbv., where 1s the comparative advantage? the global fund and world bank hn/aids programs moving forward 5 (feb. 7, 2006) availa­ ble at http://www.cgdev.org/doc/event%20docsl2.7.06o/o20hn/transcripv'/o202.7.06.pdf (noting that the report was commissioned by christopher benn, director of external rela­ tions of the global fund and jonathan brown, operations advisor, global hn/aids pro­ grams at the world bank). 207. shakow, supra note 9. 208. ld. at 38. 209. id at 47 ( .. its main focus in this regard should be on financing directly the preven­ tion and treatment of the three diseases.''). 210. id at 8 ("[t]he bank should take the lead in this area. this does not mean that the global fund should not be concerned with health system strengthening, but it should mean 612 indiana health law review [vol. 9:2 the round 5 window for hsd. ''the global fund should not include health system strengthening as a separate priority category in its round 6 and fu­ ture requests for proposals. instead, the world bank should take the lead in this area."211 while the world bank sought to return the global fund to a narrow disease-specific focus, the global aids alliance and health gap, with the support of thirty plus experts and at least 300 non-governmental organizations (''ngos"), fought to keep hss interventions as its own cate­ gory in the global fund proposal form.212 to their dismay, in april of 2006, the global fund board adopted a new proposal application which did not include a separate category for hsd interventions.213 a return to the old format did not improve. the quality of the applica­ tions. the trp was as critical of the round 6 applications as it was of the round 5. "[t]he trp was again disappointed and concerned by the low overall quality of the hss elements proposed within many of the round 6 proposals reviewed.'m4 the problems remained largely the same. "many of the weaker hss elements within proposals demonstrated several of the typical problems of other unsuccessful proposals, including being too broad and ambitious, too vague in their objectives and/or proposed activities, and with poor work plans and/or budgets.'.2ts much of the blame had to rest with the lack of a clear vision and guidance on the part of the global fund itself. as noted after round 5, the global fund has yet to clearly define the scope and extent of activities that it is willing to fund under the rubric of hss activities. this leaves the scope and definition of such activities toq vague and broad, and the current proposals there­ fore range widely?16 in the end, the trp concluded that these are policy questions that must be that the lead role in this area should generally be assigned as a matter of policy to the world bank."). 211. id at 50. 212. gorik ooms et al., medicines without doctors: why the global fund must fund salaries of health workers to expand aids treatment, 4 plos medicine (2007), available athttp://www.plosmedicine.orglarticle/infoo/o3adoi%2f10.137l%2fjoumal.pmed.0040128. 213. mid-term review 2008-2010, supra note 193, at 4; who-gf consultation, supra note 188, at 36 ("in round 6, there was no separate component for hss. applications for activities ... could only be included within the disease component for which such activities were deemed necessary."). . 214. global fund to fight aids, tuberculosis and malaria. fourteenth board meeting: report of the technical review panel and the secretariat on round 6 proposals, gf/b 14/10 revision 2 25 (2006) [hereinafter trp report on round 6), avail­ able at http://www.theglobalfund.orgldocumentslboard/14/gf-bm-14_10_trpreport round6.pd£ . 215. id at 26. 216. ld 2012] global health quest for positive synergies 613 resolved by the global fund board.217 the issue was debated at the 15th board meeting in april 2007. this provided another opportunity for proponents of the idea to raise the possi­ bility of funding hss through a separate window. others expressed con­ cern that the who be brought into the consultation process, not just the world bank.218 decision point gfibj 5/dp6 directed the global fund pol­ icy and strategy committee to study and make recommendations to the 16th board meeting on the following questions: • whether the board should continue to fund "health-systems strengthening" (hss) interventions exclusively within disease components or, in addition, establish a separate hss component for proposals to the global fund; • the appropriate parameters for allowable hss activities; • the possible use and nature of conditionality for applying for hss funding; and • the possible use and nature of ceilings for hss funding. 219 furthermore, these recommendations were to be made after seeking consultation with the wh0.220 in response, who convened what it called a "jury consultation" to discuss the broad impact of the global fund's investment strategy, and more narrowly, to brainstorm ideas in response to the four questions posed by the global fund board.221 after surveying the changing landscape be­ tween ghis and hsd and noting the significance of country context and diversity, the who framed its challenge as follows: the question is how to ensure the global fund's in­ vestment approach to hss adequately reflects this [country-specific] diversity; does so in a way that re­ duces uncertainty and is based on clear criteria; has benefits for other health priorities--or at least does no harm, and stays true to its business model of being 217. !d. ("the trp therefore recommends that the board convene a suitable forum which can discuss and attempt to resolve the question of the appropriate scope and definition of acceptable hss activities prior to round 7 ."). 218. global fund to fight aids, tuberculosis and malaria, sixteentii board meeting: report of tile fifteenth board meeting, gf/bl6/2 revision 1 8 (2007), available at http://www.theglobalfundorgldocuments/board/16/gf -bm 16-02-report _ fif­ teenth_ board_ meeting. pdf. 219. jd. at 12. 220. jd. 221. this process generated the who document, the global fund strategic approach to health system strengthening report from who to the global fund secretariat, which was to assist the policy and strategy committee in preparing its hsd recommendations to the sixteenth board meeting. who-gf consultation, supra note 188. 614 indiana health law ~view country led, multi-stakeholder-driven innovative and results foctised.222 [vol. 9:2 this is a tall order. in its efforts to address these issues, one can see the seeds being laid for what, in six months time,· would become the who psc. in response to the question of possible ''parameters for allowable hss activities," the who warned of the dangers ofrigidity.223 what the global fund needed was a process that facilitated systemic, rather than isolated health system interventions and a process that was true to the fund's core business model. the key problem seems to be less the lack of more specific parameters and more that many proposals still contain actions that are vague, and proposed in isolation from the wider health system. this makes it difficult to judge the extent to which the mix of activi• ties proposed constitute or ·are part of a balanced package of interventions that fit with national policy .· and strategy in the country concerned.224 if this is the case, then narrow parameters· are to be avoided. "the parame;.. ters for allowable hss activities should remain broad. . . . [t]here is a strong view that there should be few prescriptions, flexibility is key be­ cause of country diversity, and because it helps encourage innovation."225 the treatment of parameters laid the foundation for the dominant themes of the report. the specific criteria matter less than constructing healthy, open processes and stimulating a more effective, enabling envi­ ronment for generating high quality hsd proposals. the key is to focus on what works.226 the report quotes one participant of the july ~onsultation as stating: ''the global fund should retain the principle of 'give us a good plan and a· good justification and we'll fund it."'227 the challenge then is how does one create the environment that generates sound proposals? the who suggests the following: • better guidance is needed ... but no blueprints • co-operation/coordination among partners is very important to 222. id. at 3. 223. /d. at 4. 224. /d. at 5. 225. id at6. 226. ld at 5 ("a strength of the global fund's business model is that it is prepared to fund technically sound and well-justified proposals. j. 227. id. at 6. 2012] global health quest for positive synergies 615 ensure most effective use of all available funds • funding for t a [technical assistance] for proposal develop­ ment and implementation is essential • partners need to strengthen capacity to deliver relevant ta for health system strengthening-both for proposal development and imple­ mentation. 228 the question of what role "conditions" should play received the same an­ swer as that of parameters. strict conditions should be avoided. "the few­ er conditions the better, but countries need to know what is expected. guidance is needed and wanted."229 the role of ceilings for hss funding raises a different set of questions. in this new, uncertain environment, ceilings could help control organiza­ tional risk and insure against dilution of the global fund's core mandate.230 indeed, while ga vi has maintained a separate window for hss applica­ tions since 2005, it has imposed ceilings on potential expenditures at both the aggregate and the country-specific levels.231 if the underlying problem is uncertainty, however, ceilings have their limitations. ceilings may cap risk, but they do not help manage risk by generating new knowledge and understanding. in the end, the who argues that the underlying risk associ­ ated with hsd should be managed through well-functioning processes, ra­ ther than being arbitrarily capped by ceilings. as a result, the report recommends that the global fund "[a]void ceilings."232 this advice, how­ ever, requires no small leap of faith and substantial trust in the power of well-designed (but still undeveloped) processes. the rest of the report is devoted to making the case that the fund should take such a leap of faith. the specifics of the debate come in the context of whether the global fund should maintain a separate window for hss applications. in a subtle but important point, the report argues that the "question of an hss window is a procedural not a policy question.'.z33 in this sense, heated qebates over whether there should be a separate window for hsd applications may be as unproductive as heated debates over verti­ cal versus horizontal interventions. the report reminds the reader that the global fund's technical review panel was equally critical of round 5 ap­ plications (where there was a separate window) and round 6 applications (where hsd applications were integrated into specific disease compo228. ld. 229. !d. at 7. 230. !d. at 8. 231. !d. at 41 (annex 6) (experiences of the ga vi alliance health system strengthen­ ing investment). 232. !d. at 10. 233. id. at 12. 616 indiana health law review [vol. 9:2 nents).234 for the most part, they were all bad. for the who, the challenge is cultivating well-designed proposals, not the form in which such proposals are submitted. that said, there are ways in which form can make a difference. the report raises a legitimate concern that the disease-specific application re­ quirement may make it more difficult to generate proposals that are holistic and cognizant of the entire health system. the practical problem with having hss within a dis­ ease component application is to do with the process by which proposals are developed. if the process con­ tinues to be seen as largely the province of an indi­ vidual programme and its more disease-focused partners, then few will address health system con­ straints in a truly systemic way, and the risk of unin­ tended, unwanted repercussions on the other programmes and services will be greater.235 conversely, there may be ways in which the frame of a separate win­ dow might be more conducive to systems thinking, and also be more open to the types of causation and interrelationships that characterize complex adaptive systems. the main arguments deployed for having a separate hss component are that there are more opportunities for "integration;" that it is the only way to initiate truly systems-wide action; that it is an additional way of signaling the global fund's support for hss, and might make it eas­ ier to mobilise hss technical support. 236 the report does not make a final recommendation on the question of the separate window for hss support, noting that "opinion remains divided . ..2l7 instead, it concludes with an ar­ gument that if the right "enabling environment" is put into place, then the question of integrated disease-specific proposals for hss verses a separate window really becomes academic. 238 if the proper enabling environment is present, then the significance of what particular application form or process the global fund uses and how they are drafted will start to fade. in response to the who consultation and the recommendations of the fund's policy and strategy committee, the 16th board meeting adopted 234. who-gf consultation, supra note 188, at 10. 235. /d. 236. id at 11. 237. /d. 238. /d. at 12 ("the window question becomes less important if key aspects of the ena­ bling environment are addressed: better access to infonnation; access to the right sort of technical assistance, and procedures that further encourage a 'diagonal approach."'). in retrospect, the significance of developing a workable conceptual framework, generating better empirical evidence and processes that would facilitate learning for hsd should be added to the definition of what constitutes an effective "enabling environment." 2012] global health quest for positive synergies 617 decision point gfib16/dpjo, strategic approach to health system strengthening.239 the global fund renewed its commitment to "provide funding for health systems strengthening (''hss") actions within the overall framework of funding technically sound proposals focused on the three dis­ eases. "240 the principles that it adopted to guide future hss activities are consistent with the spirit of the who consultation. ''the global fund shall allow broad flexibility regarding hss actions eligible for funding, such that they can contribute to system-wide effects and other programs can bene­ fit.'.241 ultimately, the global fund committed itself to develop a robust process to manage the hss grant application process (and control the asso­ ciated risk) rather than adopting a strict regulatory approach. it was willing to take the who's proposed leap of faith and trust process rather than pre­ scription. 242 in a move that disappointed a number of critics, the board did not re­ instate the separate window for hss applications. instead, the board con­ tinued to encourage the integration of ''requests for funding hss actions within the relevant disease component(s).'.243 at the same time, the board did permit certain "cross-cutting hss applications,'' proposals that would affect two or three of the targeted diseases, to be submitted as a distinct part of one of the disease· components. 244 furthermore, the trp would be grant­ ed the discretion of approving the disease-specific and the cross-cutting re­ quests, only the disease•specific component or only the cross-cutting component.245 the subtleties of creating process-oriented reforms can easily be lost on external audiences. moreover, the effectiveness of new processes is an empirical question that can only be judged over time. the symbolic signifi­ cance of the presence or absence of the separate window is what caught public attention, and the board's decision was widely viewed as a retreat by the fund of its commitment to hsd. this impression was reinforced by a change in the round 7 guidelines. "round 7 emphasized for the first time a request for applicants to demonstrate that they had thought through the implications of proposed activities on other health services and had plans for risk mitigation where needed.'.246 239. sixteenth board meeting, decision point gfib16/dpjo, strategic approach to health system strengthening, global fund to fight aids, tuberculosis and malaria (nov. 2007) [hereinafter decision point gfib16/dp1uj, available at http://www.who.int/ healthsystems/round9 _ll.pdf. 240. id. at 1. 241. /d. 242. /d. ("global fund shall develop guidance with few prescriptions for applications for hss funding."). 243. /d. 244. /d. 245. /d. at 1-2. 246. who-of consultation, supra note 188, at 37 (italics omitted). 618 indiana health law review [vol. 9:2 from one perspective, this is a positive development. it stresses the "first do no harm" principle. moreover, it reflects recognition that if the fund is not careful, its programs can damage other aspects of health sys­ tems. from a different perspective, however, particularly in light of the fund's failure to make substantial affirmative progress on the hsd front, the change could be interpreted by external audiences as a devolution of the fund's commitment to hsd-a change from an affirmative commitment to help build health systems to a more modest and less ambitious· pledge of avoiding undue harm. in many respects, 2007 was a low point for the global fund. a de­ cember 2007 article in the l.a. times reflected the critical public mood. 247 according to the article, the global fund had only given one percent of its funds directly to hss.248 in its defense the global fund claimed that almost half of its aids funds went toward training, monitoring, evaluation and administration, and thus a significant amount of money went indirectly to strengthening health systems. 249 nonetheless, the l.a. times article criti­ cized the global fund for its predominately vertical orientation, noting that a narrow focus on its own mandate could have negative effects on health systems as a whole. simply put, "[m]any believe that its [the global fund's] tight remit is increasingly becoming a straitjacket.'.2so ultimately, the article warned that the global fund must not assume that just because it is providing aid, that it was doing no harm. it must question whether the overall effect it is having is indeed positive. . c. rounds 8-10 (2008-2010): time, persistence and the power of adaptation the mark of a successful institution id. a changing environment is its ability to learn and adapt. the core structure of the global fund gives it this potential. its most recent experience with hsd illustrates that capacity. while it is still too early to make a pronouncement on the fund's ultimate effectiveness in hsd (the same can be said of the entire who psc effort), important changes between round 7 and round 10 place the fund on a pos­ itive trajectory. interestingly, in round 8 the changes were associated less with what the global fund said (the governing language changed very lit­ tle) and more with what the fund did. by round 10, there were substantial changes in the language the global fund used to guide its hsd work, as 247. charles piller & doug smith, unintended victims of gates foundation generosi­ ty, donations to fight aids. tb, and malaria in africa have inadvertently put many of those with other basic healthcare needs at risk. l.a. times (dec. 16, 2007), available at http://www.latimes.com/news/nationworldlnation/la-na-gatesl6decl6,0,3743924.story. 248. id. 249. !d. 250. /d. 2012] global health quest for positive synergies 619 well as its actual conduct. the guidelines for round 8 were revised in a manner to implement the 16th board's directives in decision point gfibj6/dpi0.251 in march 2008, the global fund published a fact sheet: the global fund's ap­ proach to health system strengthening, providing a statement that consoli­ dated and synthesized its policies.252 as in the past, the fund still required proof of a direct linkage between proposed hsd activities and improved outcomes for the three targeted diseases.253 how does one establish such linkage? the facts sheet uses buzz words such as "constraints," "weak­ nesses" and "gaps" in characterizing these assessments. "the global fund recognizes the importance of supporting the strengthening of public, private and community health systems where weaknesses and gaps in those sys­ tems constrain the achievement of improved outcomes in reducing the bur­ den of hiv, tuberculosis and malaria!'254 applicants must "clearly articulate how the interventions will address identified health systems con­ straints to improved hiv, tuberculosis and/or malaria outcomes (although [the global fund] recogniz[es] that interventions may benefit other disease outcomes also )."255 ultimately, such demonstrations must be made within the context of some conceptual understanding of what health systems are and how they function. the fact sheet continues to discuss the building block approach developed by the who and specifically cites the 2007 who publication everybody's business. in the context of the global fund's mandate, hss re­ fers to activities and initiatives that improve the un­ derlying health systems of countries in any of the six areas [building blocks] identified above, and/or man­ age interactions between them in ways that achieve more equitable and sustainable health services and health outcomes related to the three diseases.256 251. among other things, the "hss funding framework was refined to integrate re­ quests for hss within a disease proposal or to use a distinct cross-cutting hss section within a disease proposal." mid-term review 2008-2010, supra note 193, at 4. there remained no separate window for hsd applications. 252. global fund to fight aids, tuberculosis and malaria, fact sheet: the global fund's approach to health system strengthening (2008) [hereinafter global fund fact sheet], available at http://www.theglobalfund.orgldocumentslhss/hss_ glob­ alfundapproachtohss _ factsheet _en/. 253. id at 1 ("with a strong focus on ensuring linkages between and outcomes for the three diseases, the global fund remains committed to providing funding for health systems strengthening (hss) within the overall framework of funding technically sound proposals."). 254. id. 255. /d. at 2. 256. id at 1. 620 indiana health law review [vol. 9:2 the building block approach has its limitations and risks static and stilted thinking. the mention of managing potential "interactions" between the functions is the only suggestion in the 2008 fact sheet of possible interrela­ tionships and dynamic interconnections between the separate functions. although the fact sheet makes multiple references to "cross-cutting" pro­ posals, such proposals only envision potential interactions between the pro­ posed intervention and two or more of the targeted fund diseases. this is just a small first step. it is only when one acknowledges the cross-cutting aspects of the diseases, in combination with the cross-cutting aspects of the different health system functions that the true complexity and interconnect­ edness of the problem begins to be appreciated. 257 there are creative ways in which the use of the application process it­ self can transcend the limits of a static framework. in particular, two fund requirements help open the door to more complex and dynamic understand­ ings of health systems, in practice, if not in theory. the fund encourages hss proposals to be consistent with broader in-country assessments and proposals for national hsd.258 in addition, the fund encourages that the proposal be generated by a participatory, multi-stakeholder process (not unlike that advocated in the systems thinking ten-step design process). to support the preparation of strong, appropriate re­ quests for funding for hss cross-cutting interven­ tions, the global fund recommends that health systems and cross-disease focused in-country stake· holders are involved in the ccm and in proposal de­ velopment. in particular, the global fund encourages applicants to include stakeholders who are involved in the planning, budgeting and resource allocation pro­ cesses for the d.ational disease programs and health system reform, and explain the role of these stake­ holders in the proposal that is submitted. 259 these devices provide avenues in which the complex, context-specific and interconnected aspects of health system interventions can begin to be incor­ porated. 257. the language that the global fund uses to establish "linkages" is not very helpful in this regard. "constraints," "weaknesses" and "gaps" resonate more with mechanical sys­ tems and linear notions of causation than they do with complex adaptive systems. that said, there is nothing inherent in these terms or concepts that prevents them from being applied to a more dynamic and adaptive understanding of health systems. if decision makers were so inclined. 258. gwbal fund fact sheet, supra note 252, at 2 ("applicants are also encouraged to draw on recent assessments of health system weaknesses and gaps (which may be broader than the three diseases. where they exist) when preparing their proposals."). 259. id 2012] global health quest for positive synergies 621 furthermore,· grant making processes, particularly within a broad framework that is results-oriented, can create a dynamic and evolutionary' environment that is itself conducive to learning and adaptation. this learn­ ing can be inductive as well as deductive. one method of learning is the accumulation of successful examples and illustrations over time. the global fund guidelines has used this approach. the guidelines for round 1 listed only one example of a potential hss activity, "strengthening of comprehensive commodity management systems at the country level. "260 in round 2, the guidelines included four examples, ranging from increased access to health services, to recruitment and training of community health workers to improved information systems?61 by round 7, there was a di­ verse array of fifteen examples of hss strategic actions?62 in addition to the accumulation of examples in the guidelines, a small cottage industry has been created, which attempts to parse the global fund guidelines and trp reports and to advise countries preparing their applications.263 as part 260. who-gf consultation, supra note 188, at 37. 261. id 262. id 263. physicians for human rights has been one of the most active organizations in this regard. eric friedman, guide to using round 9 of the global fund to fight aids, tubercu­ losis and malaria to support health system strengthening: updated from march 2007 guide developed for round 7, in physicians for human rights, toolkit for using round 9 of the global fund health systems strengthening (2008), available at http://pdf.usaid.gov/pdf_docs!pnad0138.pdf. the grant application and review process is not unlike the common law system for adjudicating disputes. one can distill from the pro­ cess sets of principles that can help explain past conduct and possibly guide future action. physicians for human rights has generated a list of features common in successful applica­ tions: 1. strong links to reducing spread and impact of target diseases 2. strong health system analyses 3. national commitment and strategies 4. strong chance of success 5. pro-poor and pro-marginalized populations 6. support from other development partners 7. discrete focus 8. address major obstacles !d. at 36-37. the who has conducted similar assessments. in advising applicants it stress­ es the importance of the following: 1. the proposed activities clearly respond to constraints ... 2. the proposed activities are required in order to in improve hiv i aids, tb or malaria service delivery ... 3. the proposed activities fit within overall national health policies ... 4. the proposed activities have been defined in consultation with key stakeholders ... 5. proposed activities are clearly defined; of realistic scale, and credibly costed ... 6. returns from investment are possible within a reasonable timeframe ... 7. a small set of credible health systems indicators have been selected for tracking progress .... 622 indiana heal1h law review [vol. 9:2 of an iterative, adaptive process, these considerations can collectively help define an increasingly viable set of effective hss interventions. the grant review process is subject to other influences as well. the broader political climate both inside and outside the global fund has changed in a manner that is more supportive of hsd efforts. early rounds made almost no progress on the hsd front. things started to change by round 5, as illustrated by the case of malawi. commenting on the hss proposal from malawi the trp reflects that although the human resources con­ straints were recognized as crucial in round 1, "at that time the global fund was not keen to fund health system components," indicating that the approach of the panel has undergone some change since the early rounds.264 this trend has continued. whether looking at the number of applications (113 proposals with hss strategic actions (round 7) and 45 proposals with hss components (round 8)) or the amount of funding approved ($364 million (round 7) and $591 million (round 8)), applications in rounds 7 and 8 were substantially more successful than those in previous rounds. 265 as a result of the global fund's cumulative experience and self­ assessments, hsd has become a more active institutional priority. one of the findings of the five-year evaluation was that "[h]ealth systems in most developing countries will need to be greatly strengthened if current levels of services are to be significantly expanded."266 given that most of the pro­ gress the fund has made to date has been in areas that already had some­ what functioning health systems, improving the performance of weak health systems is absolutely essential for future progress.267 "going forward, the weaknesses of existing health systems critically limit the performance po­ tential of the global fund. "268 but if future hsd efforts are targeting weaker health systems, all parties involved must appropriately recalibrate what timeframes, outcomes and results are realistic under such circumthe global fund and health systems strengthening: how to make the case, in a proposal for round 8? (working draft), world health org. 3, available at http://www.who.int/ healthsystems/gf_ hss.pdf. 264. drager et al., supra note 185, at 9 (quoting global fund to fight aids, tuberculosis and malaria, eleventh board meeting: report of the technical review panel and the secretariat on round five proposals (2005), available at http://www.who.int/healthsystems/gf8.pdf). 265. mid-term review2008-2010, supra note 193, at 4. 266. five-year evaluation, supra note 177, at21. 267. !d. at 24 ("study area 3 found that the scale-up of hiv services has primarily occurred thus far in districts with stronger health systems and higher levels of socioeconomic development-so it is likely that health system constraints will become increasingly im­ portant as services roll out to weaker districts in the future."). 268. !d. at 21. 2012] global health quest for positive synergies 623 stances. weaker infrastructures will require a .focus on more basic hsd interventions and will require longer timeframes. "in particular, for coun­ tries with weak health systems and/or high disease burden, grants should either focus more on investing in long-term capacity building, or demon­ strate partner contributions to capacity-building."269 the most significant external event influencing global fund thinking about health systems has been the who psc. psc has helped transform the political and analytic environment for hsd. changes in global fund guidelines governing round 10270 and the recently published information note on the global fund's approach to health system strengthening ("hss"), 271 illustrate the dramatic impact of these developments. while some of the terminology remains the same,272 there have been important changes in the contexts in which this language is applied. first, rather than being neglected as in early rounds, the fund now recognizes hsd as a top priority and as a fundamental prerequisite to accomplishing sustained health outcomes. strong and effective health systems are increasingly considered a prerequisite to effective implementation of disease control interventions. recognizing the crit­ ical importance of the linkages between health sys­ tems strengthening (hss) and outcomes for hn, tb, and malaria (as well as other health outcomes), the global fund is committed to providing funding for hss within the overall framework of funding techni­ cally sound disease proposals.273 this changes the baseline against which hsd proposals are evaluated in a manner that should fundamentally change old notions of linkage and causa­ tion. while applicants still bear the burden of making a persuasive case, the inherent significance of hss to effective action is now the· default value for analysis. in asking "[ w ]hy is it important to address health systems strengthening in funding proposals to the global fund?'' the fund answers 269. !d. 270. guidelines for proposals-round 10 single country applicant, global fund to fight aids, tuberculosis and malaria (2010) [hereinafter round 10 guidelines], avail­ able at http://web.nbnet.co.kelglobalfundnew/images/rl0%20proposal%20guidelines.pdf. 271. global fund to fight aids, tubercolosis and malaria, global fund information note: the global fund's approach to health systems strengthening (hss) (201 0) [hereinafter hss information note]. 272. id. at i (''the global fund recognizes the importance of supporting the strengthen­ ing of public, private and community health systems where weaknesses and gaps in those systems constrain the achievement of improved outcomes in reducing the burden of hiv, tuberculosis and malaria."). 273. id. 624 indiana health law review [vol. 9:2 itself: "{ t] here is a strong link between health systems and the global fund's mission to fight the three diseases.'t274 second, round 10 now expressly recognizes the need to consider complexity and interdependence in its analysis of health systems. the new hss information note makes obligatory reference to the who's building blocks, but there is a stronger appreciation that the building blocks cannot be understood in an isolated or static manner. significantly, the hss infor­ mation note cites the alliance for health policy and systems research's 2009 publication systems thinking for health systems strengthening as one of its two suggested references for further readin!f75 "lessons learned from previous funding rounds underscore the importance of ensuring that appli­ cants provide a holistic consideration of these building blocks when inte­ grating them into a funding request. applicants should pay particular attention to the interdependence of blocks, rather than a fragmented consid­ eration of individual blocks.'m6 in elaborating on the lessons learned from the trp, the document stresses the need to "describe the linkages and interactions present in the health system. "277 the document continues: many applications in previous rounds have often re­ quested a "shopping list" of all theoretical hss needs, without giving thought to longer-term hss program­ matic planning and expected impact. applicants are encouraged to base their hss proposals on an under­ standing of the complex nature of the interactions be­ tween health systems components, functions, institutional and structural elements. in addition to focusing on specific health system components, hss proposed interventions should also consider interac­ tions among the cogronents and the broader context in which they exist.27 one implication is that the global fund calls for a more balanced approach to hss.l79 these changes should create the space for more innovative, far274. id. at 2 (emphasis added). 275. ld. at 5 (citing alliance for iiealih poucy and systems research & world iiealih oro., systems thinking for iiealih systems s1rengihening (2009), available at http:/ /whqhbdoc. who.int/publications/2009/9789241563895 _eng. pdf). for an extensive discussion of systems thinking for health systems strengthening see supra part ill. c. 276. id. at 2. 277. i d. at 4. 278. /d. 279. past rounds, for example, seemed to focus predominately on service delivery, ·often to the neglect of finance and governance. id. at 4-5 ("applicants are thus encouraged to propose more balanced hss interventions based on country needs that cover a range of 2012] global health quest for positive synergies 625 reaching and effective proposals to be considered as part of the global fund's future grant making process. third, in addition to changes in analytic content, round 10 represents an important broadening of the scope of the fund's hsd efforts. signifi­ cantly, the global fund is now willing to consider hsd proposals that will benefit women and children in addition to the three traditionally targeted diseases.280 "the global fund recommends integrated approaches to achieve the following millennium development goals ("mdgs"): 4 (re­ ducing child mortality), 5 (improving maternal health) and 6 (combating hn, malaria and other diseases) and improve health outcomes for women and children. "281 this is an important development that should encourage holistic proposals that approach health systems as a more integrated whole. "countries that fail to take advantage of this miss an important opportunity to develop strong health sector systems which benefit health outcomes be­ yond the three diseases.'.282 finally, round 10 also broadens the scope of hss activities to ex­ pressly embrace communities and civil society as plus factors in the quest for positive synergies. the global fund also recognizes that non­ government organizations, the private sector and communities affected by the disease(s) are each an in­ tegral component of the health system, as is the gov­ ernment sector. likewise, community systems include government, non-government and private ac­ tors working at the community level. health systems and community systems are connected and comple­ mentary to each other?83 the global fund now maintains that building community systems will be an essential part of strengthening health systems. 284 round 10 will support health system components."). 280. jd. at 2 (''the global fund shall however allow broad flexibility regarding hss actions eligible for funding, such that they can contribute to system-wide effects and other programs, particularly those affecting the health of mothers and children, can benefit (not only those addressing the three diseases."). the focus on women and children is part of a call for greater sensitivity to gender issues more generally. "it is important to use a gender sensitive approach to the three diseases. proposals should be based on an assessment of how the diseases impact women and girls differently compared to boys and men, and take actions to respond to these differences." round 10 guidelines, supra note 270, at4. 281. hss information note, supra note 271, at 2. 282. jd. at 4. 283. round 10 guidelines, supra note 270, at 60. 284. global fund to figiit aids, tuberculosis and malaria, global fund information note: communtiy systems strengthening (2010) [hereinafter css information note), available at www.theglobalfund.orgldocuments/rounds/10/rio_ ln­ focss_note_en/ ("community systems are community-led structures and mechanisms used by community members and community based organizations and groups to interact, coordi626 indiana health law review [vol. 9:2 "health and community systems strengthening to improve implementation and service delivery, and in particular, strengthening core institutional ca­ pacity through physical infrastructure development, and organizational and systems strengthening."285 community system strengthening ("css"), like hss, is to be a routine part of the global fund grant making process.286 from 2002 to 2010, the global fund has gone from embracing mis­ guided assumptions that health systems would somehow take care of them­ selves, to taking bold new action where hsd is recognized as essential to its core mission. this vision has now been extended beyond health systems to embrace community systems as a plus factor for hsd. the challenges that this will entail are examined next. v. communi1y challenges-incorporating a role for civil society holistic thinking about hsd has to include a role for people, partici­ pation and civil society. psc and the global fund have both striven to in­ corporate community system strengthening ("css") into their health systems agendas. this section examines these developments and considers how . civil society and community systems fit as plus factors within the broader building-block-plus framework for hsd. the tremendous chang­ es that have taken place just from 2008 to 2010 are a further indication of how far and how fast activities are evolving at the ghvhsd interface in the wakeofpsc. a. the convergence of civil society, community systems and health systems given the inherent locality of health services, sustainable public health intervention must ultimately be rooted in the community. the psc civil society panel explains the rationale: "communities and civil society are at the heart of strong, accountable health systems at the grassroots level, they represent the end users of health services; they are also engaged in imple­ mentation, service delivery, planning and priority setting, advocacy, and monitoring and evaluation (m&e)."287 as with other dimensions of the nate and deliver their responses to the challenges and needs affecting their communities."). 285. round 10 guidelines, supra note 270, at 86. 286. !d. at 61 ("(t]he global fund encourages the applicant to include community sys­ tems strengthening measures on a routine basis in proposals to the global fund."). 287. final report cml society consortium, supra note 61, at 1. active civil socie­ ty participation is the lifeblood of most public health movements. "the crucial contributions of empowered and informed civil society in stimulating community demand, expanding access to health services, extending coverage for marginalized populations, protecting and promoting rights-based approaches to health, and strengthening health systems governance precede and contributed greatly to the recent launch of new global health initiatives (ghls)." !d. 2012] global health quest for positive synergies 627 ghi-hsd interface, we are still, both theoretically and empirically, at the early stages of the learning curve in understanding how civil society can best assist ghis and other local hsd efforts. many important questions remain unanswered. "what are the right roles of civil society in optimizing the interactions between global health initiatives and national health sys­ tems, in order to capitalize on positive synergies and minimize negative impacts?'.288 "what reforms and actions should gills take to be more re­ sponsive to grassroots civil society priorities and health needs?'.289 "how can csos [civil society organizations] work with governments and/or gills to navigate implementation roadblocks? what are csos doing al­ ready?'.m much can be learned from experience in recent decades, but more work still needs to be done. just as there have been profound changes in the global fund's under­ standing of hsd, there have been similar advancements in the global fund's understanding of community-based organizations ("cbos") and css. the primary strength of the fund is its capacity for learning and ad­ aptation. 291 these traits have led the organization to recognize the im­ portance of community systems and make serious commitments to their development. starting with a resolution at the 15th board meeting and first implemented in the round 8 guidelines, the global fund recommend­ ed ''the routine inclusion, in proposals for global fund financing, of re­ quests for funding of relevant measures to strengthen community systems necessary for the effective implementation of global fund grants.'.292 ap­ preciating the complexity of social-health dynamics, css efforts are being taken in tandem with efforts to address the complementary challenges of gender inequality and the needs of other marginalized groups. 293 global fund's understanding of css has progressed substantially even between the march 2008 publication of its first fact sheet: communi288. i d. at 2. 289. ld. at 3. 290. ld 291. global fund to fight aids, tuberculosis and malaria, civil society success on the ground: community systems s'irengthening and dual-track financing: nine illustrative case stijdibs 3 (2008) [hereinafter civil society success on the ground], available at http://www.theglobalfund.otwdocuments/civil_society/ civilsociety _ cssanddualtrackfinancing_ casestudy _en/. !d. many would recognize that the global fund to fight aids, tuberculo­ sis and malaria is a continually developing institution, evolving as a re­ sult of feedback from its key stakeholders. the organization's eighth funding round, launched in march 2008, and its impending round 9 to be launched in october 2008 represent the culmination of a number of mechanisms to harness and enhance the role of civil society in the im­ plementation of global fund grants. 292. ld. at 6. 293. id. at 7. 628 indiana realm law review [vol. 9:2 ty systems strengthenin~ and the may 2010 publication of its updated information note: community systems strengthening295 and accompanying report community systems strengthening framework. 296 the global fund's interest in community systems is very pragmatic. the fund cares about community systems because it believes that community organizations are important to the sustainability and effectiveness of the fund's work.297 as such, communities, community systems and civil society are important pieces to the puzzle ofhsd. theorizing about health systems is a new and quickly evolving field. initial hsd work largely overlooked civil society, leaving the role of com­ munities undervalued and under-analyzed. 298 neglect in conceptualization inevitably leads to neglect in terms of funding.299 upon reflection, howev­ er, it is clear that every hsd framework, including the who building block approach, implicitly incorporates roles for civil society. 300 none of these building blocks exists in social isolation. building on this insight, commu­ nity systems and health systems need to be viewed as overlapping and in294. global fund to fight aids, tuberculosis and malaria, fact sheet: communtiy systems strengniening (2 of 5) (2008). 295. css information note, supra note 284. 296. community systems strengthening framework, global fund to fight aids, tuberculosis and malaria (2010) [hereinafter css framework], available at www. who.int/entity/tb/dots/comm_ hss.pdf. 297. css information note, supra note 284, at 1. community organizations and networks have a unique ability to interact with affected communities, react to community needs and issues and connect with affected and vulnerable groups. they provide direct ser­ vices to communities and advocate for improved programming and poli­ cy environments. this enables them to build community contributions to health, and to influence the development, reach, implementation and oversight of public systems and policies. 298. final report cml society consortium, supra note 61, at 55 ("although ghis have helped to advance new standards of civil society involvement in health service delivery and governance, constituencies focused on health systems strengthening often do not em­ brace a model of the health system that fully integrates civil society involvement at all stag­ es."). 299. css framework, supra note 296, at 11. the report speculates as to the possible reasons for this neglect. id. at 12. lack of clarity in the past has made it difficult to discuss how communi­ ty systems relate to health outcomes and how they link with health sys­ tems. one reason may be that community systems are often more fluid and harder to define than the structured systems of a health or social support service. another reason is that it is difficult to define exactly what the boundaries between health and community systems are, and to identify the links between them. 300. final report civil socmty consortium, supra note 61, at 3 ("who describes six essential building blocks needed for strong health systems .... although not explicit in who's model, civil society and communities cut across each building block, engaging in distinct activities in each category!'). 2012] global health quest for positive synergies 629 terdependentnetworks.301 "this approach by the civil society consortiunr­ of communities at the centre of thriving health systems, and of health sys­ tems strengthening and community systems strengthening as interdependent efforts-complements the conceptual framework of the [psc] academic consortium."302 these understandings are also consistent with incorporat­ ing civil society as a plus factor within the building-block-plus framework developed earlier. but what does css entail? according to the global fund, css is: an approach that promotes the development of in­ formed, ·capable and coordinated communities and community-based organizations, groups and struc­ tures. it involves a broad range of community actors and enables them to contribute to the long-term sus­ tainability of health and other interventions at the community level, including an enabling and respon­ sive environment in which these contributions can be effective.303 developing a more formal framework for understanding the relationship between community systems, health systems and health outcomes is im­ portant. at one level, this will be a necessary underpinning for informed policy making. at another level, it will provide a more rational and inte­ grated superstructure in which the mechanics of grant writing, application review and program evaluation can proceed (administrative challenges). just as with hsd, an effective meta-framework requires the convergence of thinking on the political, theoretical and administrative fronts before effec­ tive policies can be designed, implemented and funded.304 /d. 301. css framework, supra note 296, at 10. through community systems, community actors currently provide sever­ al categories of activities or services that directly or indirectly affect health outcomes. these categories are not mutually exclusive and there are many synergies and overlaps within and between community sys­ tems and health systems, especially within integrated packages of care, support and protection. 302. final report civil society consortium, supra note 61, at 4. 303. css framework, supra note 296, at 7. 304. the global fund requires linkage between css efforts and the three targeted dis­ eases. a workable conceptual framework, therefore, must address the causal relationship between supporting community systems and the likelihood of improving outcomes for aids, tuberculosis and malaria. the fund, however, is adopting more open understandings of causation with css, than it initially did with hsd. indeed, fundable css projects may even lie outside the traditional health sector. in the past, it has been difficult for community actors to explain clearly 630 indiana health law review [vol. 9:2 css efforts are taking a proactive role in this process. in its early days, the fund neglected hsd on the mistaken belief that the strengthening of health systems would naturally follow the development of gill pro­ gramming. this reflected a strong, and ultimately misguided, faith in the powers of private ordering. the difference between this perspective and the css framework parallels that between night and day. in many respects, the css framework is a comprehensive effort to identify the multiple factors that prevent effective forms of private ordering in remote comers across the globe and to develop plans to help facilitate more effective forms of local cooperation. this realization also explains one of the frustrations in reading the css framework document. it is diffuse, multi-layered, and difficult, if not impossible, to summarize in a short, concise manner. two sets of intuitions are useful in making sense of the css frame­ work. the first is derivative of the standard state-market-civil society mod­ el from political science. in robust and effective polities, civic society interacts with the state and with private markets in ways that make each component function more effectively. civil society can be a source of thinking, inspiration and advocacy for public programming. civil society can monitor state and market performance and act as a watchdog. monitor­ ing and advocacy work is an ongoing process to prod, push and lead social policy in directions that better serve the public interest. one objective of css, therefore, is to empower civil society to more effectively serve these traditional functions. the second set of useful css intuitions is derivative of institutional economics. the state (and the market) can only function when they are supported by robust and effective institutional infrastructures. gills have illustrated how these institutional infrastructures are often weak and dys­ functional in many developing countries. the weaknesses of public institu­ tions become more prevalent the greater the geographic and social distance these institutions are from the center of state power. in geographically re­ mote rural areas, the public institutional infrastructure may be nonexistent. the same observation often applies when considering the needs of socially distant and politically disenfranchised subpopulations. often, no effective public institutional infrastructure exists to serve their needs either. one strategy for addressing this problem is to strengthen the public institutional infrastructure from the center-out. much of traditional hsd fits this model. a different strategy is to help build the functional equivalents of the public institutional infrastructure from the periphery in, or from the grassroots up. id at6. the connections between health outcomes and community activities that have potential impacts on health but are not directly related to health service delivery, for example advocacy, social protection and welfare services, home-based care or legal services. the framework provides a structure for addressing this and enabling inclusion of relevant non­ health activities in funding mechanisms and allocations for health. 2012] global health quest for positive synergies 631 this is one ofthe·primary tasks of new css efforts.305 painting with very broad strokes, the global fund's css framework defines six core compo­ nents of community systems. the global fund's objective is to take a complicated, abstract issue like ''the community'' and to break it down func­ tionally into an administrative framework that can be used to guide grant making and subsequent performance evaluation. in listing the components, one can get partial glimpses of the traditional state-market-civil society model and tlie institutional economic model outlined above. the six core components of the css framework are as follows: 1. enabling environments and advocacy-including community engagement and advocacy for improving the policy, legal and govern­ ance environments, and affecting the social determinants of health[;] 2. community networks, linkages, partnerships and coordination enabling effective activities, service delivery and advocacy, maximis­ ing resources and impacts, and coordinated, collaborative working; 3. resources and capacity building--including human resources with appropriate personal, technical & organisational capacities, fi­ nancing (including operational and core funding) and material re­ sources (infrastructure, information and essential commodities, including medical and other products and technologies); 4. community activities and service delivery-accessible to all who need them, evidence-informed and based on community assess­ ments of resources and needs; 5. organisational and leadership strengthening including manage­ ment, accountability and leadership for organisations and community systems; 6. monitoring & evaluation and planning including m&e systems, situation assessment, evidence-building and research, learning, plan­ ning and knowledge management.306 this is an ambitious and expansive list of activities to target for funding. the report proceeds to provide careful descriptions of each component, along with the specification of ten ancmary service delivery areas ("sdas") (discrete domains of community service activities and interven­ tions) associated with the various elements.307 305. this will not be easy. establishing effective forms of local cooperation is part of the defining struggle of human history. attempting to parachute in and stimulate effective forms of self-organization in geographic and socially remote communities that have not pre­ viously come together and worked effectively in a collective manner is a daunting challenge. 306. css framework, supra note 296, at4 (italics omitted). 307. /d. at 8, n.l9 ("programmematic interventions by civil society actors are often called activities; in health systems, interventions are usually called services; the global fund and other agencies use the term service deliyery area to cover the full range of programme­ matic activities and services-this is a key term used in this framework."). 632 indiana health law review [vol. 9:2 b. a functional approach to community systems to illustrate these principles, it 'is helpful to focus on different func­ tional aspects of community systems. these insights help orient one's un­ derstanding of the relationship between health systems and community systems. this section examines two such functional roles. first, communi­ ty systems can perform functions that might otherwise be performed by the state or the market-a surrogate or gap-filling role. second, community systems can be a bridge that connects traditional health systems with the broader social-economic determinates of health. analysis of these two functions is intended to be suggestive and illustrative of css efforts. it is by no means comprehensive. 1. civil society a surrogate health service provider civil society and community-based organizations are often used as a surrogate to· provide health services in otherwise dysfunctional states and markets. 308 it is not surprising that the importance of community systems was re-discovered when ghis experienced serious administrative and logis­ tical constraints in attempts to implement their ambitious agendas. the need for hsd generally is predicated on the weakness of the public health infrastructure in most developing countries. civil society and community­ based organizations· play their most important roles where state apparatuses do not exist or do not function effectively. this can consist of quite a large domain. in many developing countries, the reach of state bureaucratic structures seldom extends beyond major provincial towns.309 administra­ tive structures are particularly anemic in rural areas. as such, substantial portions of the population simply live outside of the shadow of the state's health care infrastructure.310 in these settings, community systems may be the only networks capable of facilitating the ~ of coordinated efforts necessary to take action to advance public health.3 1 308. final report civil society consortium provides a number of case studies and illus­ trations. final report cml society consortium. supra note 61, at 51 ("in the same vein, civil society involvement in programme implementation at community level should be en­ couraged, especially in settings where public health institutions lack capacity."). 309. the same observation can be made about wed-functioning private economic mar­ kets. dysfunctional markets and dysfunctional states, for the most part, go hand in hand. 310. final report cml society consortium. supra note 61, at 6. evidence shows that ghls are investing significant funding through civil society groups, ranging from indigenous community-based groups to large ngos. csos have played a key role in connecting communities to health care services, and helping patients navigate the health system as well as implementing health programming-especially where the health sector is weak, such as in rural areas. 311. while this discussion has focused on geographically remote rural communities, the same analysis applies to marginalized and vulnerable populations who are socially, if not 2012] global health quest for positive synergies 633 again, the tools of institutional economics are useful. one of the main lessons of the 2000 whr was the utility of separating the issue of function from the issue of organizational form. this logic naturally extends from the state to the market to civil society. the same health function can be performed by a continuum of organizational forms ranging from public to quasi-public to non-governmental to private market: [i]t is probably best to distinguish health system in­ terventions from others based on what the interven­ tion is rather than who is providing it. to take an obvious example . . . provision of tb medication is clearly a health system intervention, which may be provided by the national health system, by a faith­ based organisation or another community actor. ex­ amples ... are health-focused, but the best option for delivery at community level may be through function­ ing community systems rather than through the for­ mal public health system. 312 how one decides which organizational form should be used is context­ dependent and best determined by a careful comparative institutional anal­ ysis. in this analysis,. community systems may have a number of potential virtues. [c]ommunity systems may have comparative ad­ vantage with respect to certain health-related activi­ ties. these are specific to local contexts, but may include ensuring that services and support are availa­ ble close to people's homes, using the language skills of trusted, culturally competent community members, ensuring continuity of follow-up for people with chronic diseases, community-level promotion of health literacy, social and psychological support, changing harmful socio-cultural practices, outreach to key affected communities and individuals, and providing respite for home-based careers.313 this list is just suggestive of some of the factors that have to be considered. the role of civil society as a surrogate service provider is incorporated in the css framework.314 in the right settings, cbos can play an important geographically, distant from the state. 312. css framework, supra note 296, at 10-11. 313. ld. 12-13. 314. the fifth core component of the css framework is "community activities and services." id. at24-27. 634 indiana health law review [vol. 9:2 role in providing or assisting in the provision of health services.315 the role of civil society as a surrogate provider of health services is the most obvi­ ous area of overlap between css and hsd. at the same time, the line be­ tween community systems and health systems can be hard to draw and the role of cbos within the health system may shift depending upon local con­ text. given that community systems and health systems are in potential competition with each other as service providers, one should also expect areas of push-back and resistance within traditional health systems, such as perennial opposition by health professionals to community health work­ ers.316 openness and flexibility will be needed from both funders and or­ ganizations experimenting with these changing roles. 2. communities as a bridge to the social-economic determinants of health one of the benefits of a complementary focus on health systems and community systems is the ability to better address the social and economic determinates of health. 317 even amongst those who agree upon the goal of 315. jd. at 25. service delivery area 7, "service availability, use and quality," is associated with this component. specific activities listed within sda 7 include: !d. !d. • identification of populations most at risk and most in need of services; • identification of obstacles to accessing and using available services; • participatory development and implementation of referral sys­ tems to ensure access to and use of services, and referral to community systems for ongoing support; • planning for community based service delivery based on mapping and analysis of needs and gaps; • planning for continuous improvement of quality services through mentoring, updating of skills and information and regular re­ views of service availability, use and quality; • development of integrated service delivery systems to address the range of health, social and related needs in communities ... • development of community support centres providing a range of services such as information, testing & counselling, referrals, peer support, outreach to key affected people and communities, legal support etc .... 316. final report civil society consortium, supra note 61, at 15. community health workers (chws) remain one of the largest resources available to rapidly and effectively respond to health needs. in spite of significant recent improvements, chws and their referrals continue to be inadequately recognized by formal health systems. chws are very often poorly supported and equipped, and the vast majority of them are almost entirely uncompensated. 317. "these determinants affect people's mental and physical health and well-being at many levels. they include, for example: income and social or cultural status; education; physical environment; employment and working conditions; social support networks and 2012] gwbal health quest for positive synergffis 635 improving community health, there are serious debates about the relative importance of medical interventions versus action directed at the broader determinants of health. the css framework suggests ways in which some of these divides might be bridged. the community, by definition, encom­ passes health and non-health factors. as such, efforts to strengthen com­ munity systems may also permit the furtherance of a number of complementary social goals that might also improve health. for better or worse, the "health systems" frame is already burdened with certain implicit medical biases. the possible dynamics of these interactions are illustrated in the css framework. figure 3 of the report portrays community actors and systems and health actors and systems as intersecting circles both operating within a broader context of social, cultural, economic, political and legal envi­ ronments that influence health and the state-market-civil society construct, of which health systems and community systems are a part. 318 health systems are not something · separated from communities. they are key community assets, part of the network of relationships and support that individ­ uals, families and communities are entitled to rely on. clearly, there are synergies as well as overlaps be­ tween health systems, community systems and social welfare systems, but these should be used as a stimu­ lus for creative and innovative approaches to bring community, health and social systems into closer and more complementary partnerships.319 the proper blend of community-based and health-based interventions can help achieve this goal. "community actors are in a unique position to work on these issues alongside health, social welfare and other actors and systems. together, they can achieve the scale, range and sustainability of interventions that will help to realise people's rights and enable them to reach important goals for their health and well-being."320 to improve health, one must help improve the community infrastructure. in order to have real impact on health outcomes, how­ ever, community organisations and actors must have effective and sustainable systems in place to support their activities and services. this includes a strong focus on capacity building, human and financial rewelfare services; genetics, personal behaviour and coping skills; gender." css framework, supra note 296, at 3. 318. id. at 13 fig.3. 319. id. at 13 (footnote omitted). 320. id. at 3 (footnote omitted). 636 indiana health law review sources, with the aim of enabling community actors to play a full and effective role alongside the health, so­ cial welfare, legal and political systems. 321 [vol. 9:2 the css framework places health systems and hsd in a much broader social context.322 it acknowledges the role of multiple actors and multiple causal influences.. while it adds new dimensions of complexity, it also deepens the analysis of factors that might afford real and sustained progress on a range of social-health problems. c. enabling the enabling environment: capacity building and learning in theory, robust civil society and community systems help create an enabling environment that can lead to the more effective functioning of state and market institutions. the importance of creating enabling legal, social, po­ litical and economic environments should not be un­ derestimated. an enabling environment is essential for people to achieve their rights and for communities and community organisations to be engaged and ef­ fective. the contexts of interventions to improve health are always multi-layered, and effectiveness of interventions can be seriously impaired in environ­ ments that are hostile or unsupportive.l23 but what enables the enabling environment? a full appreciation of community systems and css is another example of complex adaptive sys­ tems being applied to health policy making. most diseases are complex, multi-factored medical and social phenomena. consequently, the long­ term effectiveness of ghis requires addressing these problems not only in 321. /d. at v. 322. some of the specific activities that could contribute to the broader determinants of health include: id at 12. • participation in local and national fora for policy change; • nutrition, housing. water, sanitation and other material support to wlnerable children and adults; • livelihood support programmes such as microcredit or savings schemes, training schemes for unemployed adults and youth and for growing food to support families[;] • support for civil rights and access to services, for example civil registration ofbirths and deaths[.] 323. /d. at 8-9. 2012] global health quest for positive synergies 637 the medical context, but also in the social and political arenas.324 to engage these dimensions, it is necessary to focus on the basic building blocks of communities and the constituents of viable manifestations of civil socie­ ty.m what does this mean in practice? the css framework's core com­ ponent 1, enabling environments and advocacy, is associated with two sdas. sda 1 is monitoring and documentation of community and gov­ ernment interventions. 326 the theory is that community organizations are in the best position to access and report critical information. gathering this information outlined in sda 1 is the first step for future advocacy, action and/or shaming that can establish forms of social and political accountabil­ ity. additionally, the information will provide the raw materials (data) that can facilitate more rational forms of planning and learning on the part of governmental and civil society actors.327 sda 2, advocacy, communication and social mobilization, takes the next logical step from monitoring and documentation to political and social action. community based organisations and networks have an important role to play in engaging with govern­ ments and other institutions at all levels (local, na­ tional, regional and global) to use well-informed dialogue and discussion to advocate for improved pol324. !d. at 15-16. the contexts of major diseases such as hn, tuberculosis and malar­ ia (and many others) are always multi-factored, and effectiveness of interventions can be seriously impaired in environments that are unsupportive or hostile. for example: adher­ ence to treatment regimens is always at risk in environments with high levels of stigma and discrimination; prevention and harm reduction interventions may be extremely difficult or impossible to deliver when certain groups of people such as drug users or sex workers are criminalised and/or marginalised. 325. jd. at 9 ("more effective community engagement and stronger partnerships be­ tween community, public and private actors are therefore essential in order to build enabling and supportive environments and to scale up effective responses by community, health and social welfare systems."). id 326. !d. at 16. 327. as such, particular activities associated with sda 1 include: • [p]lans to monitor implementation of public policies and services related to health and social support; • participation of community actors in national consultative forums; • contributing community experience and perspectives to devel­ opment of national strategies, including cross-sectoral and sector-wide approaches; • developing communication materials for specific audiences e.g. children, women, sexual minorities etc .... 638 indiana health law review icies and policy implementation. in order to play this role, community based organisations and networks need support and assistance to create and implement effective communication and advocacy plans, and to develop systems for working . with partners, govern­ ment agencies, media, and broader constituencies. 328 [vol. 9:2 while not specifically focused on the enabling environment, the other core components of the ccs framework are complementary to these ob­ jectives. these other components include building stronger community networks, partnerships and coordination (component 2), improved re­ sources and capacity building for community organizations (component 3) and improved internal organizational and leadership capacity (com­ ponent 5).329 one must approach this endeavor with a heavy dose of skepticism and realism. these ideas sound wonderful in the context of a graduate seminar in political science. the lesson of history, however, is that vibrant forms of civil society and effective frameworks of local cooperation to provide even basic essentials, such as clean water and effective sanitation, are often the exception, not the rule. 330 the global fund css framework may have identified the appropriate set of levers and catalysts for social change, but making it all come together in practice will not be easy. the psc civil so­ ciety consortium suggests some of the challenges that must be overcome. !d. nonetheless, barriers at the countryand ghi-level continue to prevent civil society from acting as equal 328. id. at 17. specific activities associated with sda 2 include: • mobilization of communities and key affected populations to engage actively with decision makers, and represent community issues in major discussion forums relating to health and rights; • mobilization of key affected populations and community networks to engage in campaigns and solidarity movements; • informing and empowering community members to communi­ cate and advocate for change and improving enabling environments at local level; • policy dialogues and advocacy to ensure that issues of key af­ fected populations are reflected in allocation of resources and in national proposals ... ; • documentation of key community level challenges and barri­ ers and development of advocacy messages and campaigns to communi­ cate concerns of affected populations .... 329. id. at 18-26. 330. peter j. hammer, international law and health, in textbook on global child 107, 108 (depak m. kamat and philip r. fischer eds.) (2012) (suggesting that the lack of clean water and sanitation in a community can also be viewed as evidence of the failure of effective forms oflocal cooperation). 2012] global health quest for positive synergies partners in the planning, implementation, oversight arid evaluation of gill-funded programmes. these barriers include marginalization of civil society par­ ticipants in national decision-making bodies; weak accountability of civil society representatives in capi­ tals to their constituencies at community level; lack of transparent mechanisms to participate in some gill planning and implementation efforts, and lack of re­ sources among civil society representatives to partici­ pate in relevant preparatory and planning meetings organized by government and donor partners.331 639 the css framework document lists a comparable set of obstacles. "[i]t is important not to overlook the inequalities, social hierarchies, discrimination and competitiveness that sometimes operate between community organisa­ tions, and between them and government structures. "332 many aspects of the css framework are appropriately targeted at overcoming these barriers, but the task remains formidable. for real change to happen, members of the state, market and civil so­ ciety will have to start changing their own niindsets. the psc civil society consortium final report and global fund css framework contain useful diagrams to help visualize these desired processes and outcomes. the civil society consortium envisions "community mobilization for comprehensive health services," sitting at the center of a number of attributes reflecting the comparative strengths of community-based organizations.333 "these areas of civil society expertise include evidenceand needs-based advocacy, im­ plementation, grassroots community experience regarding what works, ser­ vice delivery for excluded populations, the ability to identify gaps and challenges, and the provision of independent oversight and monitoring. "334 another figure tries to portray a self-reinforcing chain of "community sys­ tem strengthening," "advocacy optimizing gills" and "community led de331. final report civil 8ocmty consortium, supra note 61, at 2-3. the problems cited in kenya are illustrative: id. at22. despite welcome efforts to decentralize health planning, health workers and patients, including plwha at community level reported minimal to non-existent involvement in priority setting. and that current pro­ grammes did not . accurately reflect changing needs at the community level. layers of overlapping bureaucracy, poor coordination and lack of transparency and accountability within public and om-sponsored pro­ grammes has created leilgthy roadblocks and disbursement delays for programmes funded by the global fund, especially for cbos. 332. css framework, supra note 296, at 10. 333. finalreportclvilsocie1yconsortium, supra note 61 at 3, fig. l. 334. id. at 3. 640 lndianahealth law review [vol. 9:2 mand creation."335 the css framework portrays "community actors" and "health actors" developing and managing. "systems" to undertake "activi­ ties/services for communities" that will result in improved "health out­ comes" and "other outcomes.'.j36 · this is a helpful start, but the content and operation of community systems and health systems, while not quite black boxes, remain substantially under-theorized and underdeveloped. all the action in these diagrams takes place within "systems," but these systems are still not well understood. just as an open and evolving understanding of health systems resulting from psc, the logic of the css framework is predicated on a belief in in­ cremental, process-oriented strategies, operating· within overlapping com­ plex adaptive subsystems. the effort to construct an effective enabling environment for state-market-civil society interaction, mediated through a process of community system strengthening, is a daring and exciting exper­ iment. the question of where to begin this challenge is met with the reali­ zation that each of the different css components are important and interconnected. 337 at the. same time, the global fund is appropriately pragmatic about the challenge it is undertaking. all of the core compo­ nents of css may be important, but action can only take place one step at a time. css should always start with an analysis of how sys­ tems are already functioning, how they need to be strengthened and how they can be built into a func­ tional and coherent whole. css is a gradual process and interventions should focus on addressing all the individual components and their combined function­ ing, in order to assure delivery of quality, equitable, . appropriate and sustainable interventions and out­ comes within empowered communities. 338 as such, the css framework provides a roadmap, not a blueprint. i d. global health policy has arrived at an important juncture. the psc 335. ld. at 4 fig. 3. 336. css framework, supra note 296, at 8 fig. 2. 337. /d. at 14 the core components described below are all regarded as essential for building strong community systems. together, they will enable cbos and other community actors to deliver activities and services effectively and sustainably. they also support development of strong links and co­ ordination between different systems and actors working towards the shared goal of improving health. 338. ld. 2012] global health quest for positive synergies 641 civil society consortium identified css as a key future objective.339 the entire global fund's css framework is devoted to that objective. these policies demonstrate an increasing appreciation of the normally invisible infrastructure that underpins action at the community level. recognizing the infrastructure is the first step. taking actions to improve it is these­ cond. significantly, the ccs framework is dedicated to strengthening local capacity through the almost unheard-of provision of unrestricted core fund­ ing for local organizations. community based organisations are rich in experience and close to communities but they are often the most poorly resourced in financial terms. css must there­ fore prioritise adequate and sustainable funding for community actors-not only project funds for specific operational activities and services but, crucially, core funding to ensure organisational stability as a plat­ form for operations and for networking, partnership and coordination with others. unrestricted core fund­ ing, based on agreed structures and procedures, con­ tributes to sustainability by ensuring continuity and allowing an organisation to have the appropriate paid staff, supplies and infrastructure to build up their cho­ sen programmes in response to the needs of the com­ munities they serve.340 this is an important and far-sighted strategy. it is also potentially a very expensive one. core component 3, resources and capacity building, is most directly targeted at this objective.341 the component outlines a strategy for invest­ ing in the human resources, technical and organizational capacities and ma­ terial assets, including the physical and information infrastructures that are necessary for effective community systems. 342 on a related note, core component 5 is targeted at increasing organizational and leadership capaci­ ty.343 leadership is key, but so is accountability. 339. finalreportcivilsocietyconsortium, supra note 61, at 3. 340. css framework, supra note 296, at 9. 341. id. at 19. 342. id. ("funding for core organisational costs and for capacity building are also vital for community actors in order to enable them to provide sustainable and effective responses, as well as funding for implementation of programmes and interventions."). three sdas are constructed around these objectives: sda 4, skills building for service delivery, advocacy and leadership (human resources), id. at 2q-21; sda 5, financial resources, id. at 21-22; and sda 6, material resources-infrastructure, information and essential commodities, id. at 22-23. 343. id at 26-27. 642 indiana heal til law review accountability is an important aspect of strengthening organisations, assuring communities, stakeholders and partners that there is good stewardship of the or­ ganisations's resources .... community organisa­ tions that hold. themselves accountable to their communities will also build their capacity to engage in advocacy for greater transparency and accountabil­ ity of public bodies and governments to communi­ ties.344 [vol. 9:2 in the end, these factors are intertwined and interdependent and must be pursued in a self-reinforcing manner. just as the health system initiative, the css experiment critically de­ pends on building learning and adaptation into the very dna of the pro­ cess. to this end, almost half of the document outlining the css framework is devoted to· developing workable indicators to assess results within each sda. 345 additional research must take place in concert with the initiation of funded projects.346 significantly, even the framework document itself is envisioned as an open and adaptable construct. /d. this first edition of the css framework is a major step in the direction of enhancing community en­ gagement and effectiveness in improving health out­ comes and increasing their collaboration with, and influence on, the public and private sectors in moving towards this goal. experience with implementation of the framework will help to further improve the defi­ nition and scope of ess, which will continue to be revisited and modified in the light of lessons learned in a wide variety of communities, countries and con­ texts.347 rooting ohi action in·diverse communities around the world will not 344. !d. at 26. 345. /d. at 32-70. 346. !d. at 13. much more evidence-building and research is needed on community sys­ tems and the role of community organisations and actors in health sup­ port for vulnerable communities. this applies especially to interventions indirectly related to health (such as those focused on poverty or other health determinants) and for health-related support interventions focused on prevention, access; care and advocacy rather than direct delivery of medical services. 347. ld. at vi. 2012] global health quest for positive synergies 643 be easy, but action not rooted in the community is unlikely to be effective or sustainable. that said, in taking stock of where we are and where we are heading, it is instructive to examine the history of other such efforts. the closest analogy may be the primary health care movement of the 1970s. this movement shared many of the commitments and values of the who psc and global fund css efforts. unfortunately, the drive for primary health care and efforts to ground such action in the community did not bear the fruit its advocates desired. vi. historical challenges-lessons from primary heal1h care and alma-ata one cannot read about communities, civil society, and the global fund's css framework without thinking about how these developments relate to concepts of primary health care and the 1978 declaration of alma­ ata. the ccs framework document acknowledges this heritage.348 this part examines the relationship between the primary health care movement of the 1970s and the contemporary psc and community-based initiatives reflected in the global fund's css framework. two lessons are stressed. first, there are important parallels between psc as an open, process­ oriented policy making experiment and the early days of what became the primary health care movement. many of these more positive attributes, however, got lost in the political dynamics that ultimately produced the declaration of alma-ata. the pre-history of alma-ata serves as a caution­ ary tale as to how fragile process-oriented policy experiments can be. the second lesson is related. at the comtilunity level, the power of the css framework rests in its holistic, evolutionary methodology that seeks to ground action in the community. the declaration of alma-ata 348. id. at iv (footnotes omitted). the concept of community involvement in improving health outcomes is not a new one. it has its roots in the action that communities have al­ ways taken to protect and support their members. modem approaches to community health care are reflected in the alma ata declaration of 1978, the more recent wotk of who on the social determinants of health and the re-launch of the primary health care concept in 2008. id the re-launching of the primary care concept took place in 2008 with the publication of the who world health report primary health care: now more than ever. prlmary health care: now more than ever, supra note 144. in its only direct quotation from the declaration of alma-ata, however, the css frameworlc cites the declaration for its norma­ tive principles. not for its substantive treatment of communities or its approach to primary care. css framework. supra note 296, at 2 (quoting declaration of alma-ata­ international conference of prlmar.y health care 2 {1978)). a further indication of how those defining the contemporary civil society and community systems agenda may be distancing themselves from the traditional primary health care movement is the fact that there is not a single reference to the declaration of alma-ata in the entire final report of the psc civil society consortium. see final report civil socmty consortium, supra note 61. 644 indiana health law review [vol. 9:2 was also holistic, but it was largely devoid of workable mechanisms that could begin to deliver on its promises. instead, the declaration, and the very notion of primary health care that it trumpeted, became quagmires of inaction, statements without direction. just as psc has the potential to transcend old debates between vertical versus horizontal interventions, the css framework has the potential to transcend old debates over selective versus comprehensive primary care. the irony, however, is that if one wants to fulfill the dream of alma-ata, one should draw a direct line be­ tween the early history of the primary health care movement and the global fund's css framework, largely bypassing the 1978 declaration and its legacy. a. the positive synergies campaign and the pre-history of alma-ata the pre-history of alma-ata is as much about a man, who director general halfdan t. mahler, as it is about a time. there are interesting par­ allels between that period and today. early in its existence, the who was preoccupied with vertical campaigns of disease eradication. while boasting a number of important successes, not all health problems are susceptible to this approach. international efforts against malaria, with its heavy reliance on ddt, became a particular sotlrce of disappointment.349 critical of the predominantly vertical nature of the mass campaigns, some factions in the international health community advocated for a greater appreciation of basic health services. others recognized that effective action against the disease-specific targets, such as malaria and tuberculosis, would require both better integration of these efforts with basic health services, as well as policies that challenged the largely medicalist orientation of national and international health policy. there were calls for the who to redefine its mission and objectives in light of these concerns. realistically, however, any such reevaluation would have taken place in the politically charged en­ vironment of the cold war. these dynamics pre-date mahler's directorship (1973-88). mahler was brought into the who's central leadership in 1969 when he was ap­ pointed director of a new project systems analysis unit. a window within the who and international health policy was opening that might permit new visions and new possibilities. the focus on basic health services trans349. socrates litsios, the christian medical commission and the development of the world health organization's primary health care approach, public health then and now, 94 am. j. of pub. health 1884, 1885 (nov. 2004) [hereinafter litsios, cmc]. for more than a decade, the global malaria eradication campaign had been who's leading program. initiated in the mid-1950s, it was a strictly vertical program based on the insecticide power of ddt. only in the 1960s was it acknowledged that a health infrastructure was a prerequi­ site for the success of the program, especially in africa. id 2012] global health quest for positive synergies 645 formed itself into a concern about primary health care.350 but what did the­ se terms mean and how could the who help promote their development? mahler embodied many of the anti-establishment and anti-medicalist positions of the day, but he also held strong affirmative beliefs in the radical possibilities of people-centered processes of change. for mahler, a focus on basic health services, if done right, had the potential to transform health, communities and the who itself. "the image of change that mahler re­ peatedly evoked was change led by enlightened leaders emerging from within the system, preferably at the periphery where those in greatest need reside."351 the problem was that it was not very clear what basic health services or primary health care meant or how change centered on them could be obtained. these facts were viewed as a challenge, not an obstacle. a founding premise of the undertaking was an open acknowledgment that policy makers did not have all, or even most, of the necessary answers. a 1973 who report prepared by kenneth newell's newly created strengthen­ ing of health services division illustrates this point. the report concluded that no single or best pattern existed for developing a health services structure ca­ pable of providing wide coverage and meeting the needs of the population being served: "each country will have to possess the national ability to consider its own position (problems and resources), assess the al­ ternatives available to it, decide upon its resource al­ location and priorities, and implement its own decisions. "352 there was a role for the who, but not in its traditional capacity as the in­ ternational source of technical medical expertise. "who, the report said, should serve as a 'world health conscience,' thereby providing a forum where new ideas could be discussed as well as a 'mechanism which [could] point to directions member states should go. "'353 how does one make policy when one is not certain of what one is do­ ing, or where one is going? in this setting, it is necessary to adopt an in­ cremental, process-oriented approach, where the creation of knowledge 350. marcos cueto, the origins of primary health care and selective primary health care, 94 (11) am. j of pub. health 1864, 1866 (nov. 2004) ("from the late 1960s, there was an increase in who projects related to the development of 'basic health services' (from 85 in 1965 to 156 in 1971). these projects were institutional predecessors to the primary health care programs that would later appear."). 351. socrates litsios, the long and difficult road to alma-ata: a personal reflection, 32 lnt'l j. health services 709, 717 (2002) [hereinafter road to alma-ala]. 352. litsios, cmc, supra note 349, at 1886 (quoting who official records no. 206, annex 11, geneva, 1973, 105). 353. /d. (quoting who official records no. 206, annex 11, geneva, 1973, 105). 646 indiana health law review [vol. 9:2 becomes part of the policy making process itself. mahler acknowledged this fact in his first annual report of the who in 1974. as there were few models to "demonstrate that prima­ ry health care can come out of the villages at a rea­ sonable cost and in a manner that is technically· and socially acceptable," he indicated that it was "an ur­ gent task for who to seek a small number of innova­ tor countries that will be willing and able to set up such systems of primary health care and demonstrate their effectiveness."354 this is not unlike the incubator approach employed by venture capitalists in silicon valley and elsewhere. one needs structured experiments and learn­ ing, but mahler believed that one must also change one's very understand­ ing of what must be learned and how one defines knowledge. "only by becoming their pupil could one hope to serve regions and individual mem­ ber states."355 concrete steps in operationalizing these objectives came in the compi­ lation of two series of case studies of innovative, non-traditional primary health care experiments. the first was the product of the unicef and who joint committee on health policy, alternative approaches to meet­ ing basic health needs in developing countries, published in 1975.356 that year also witnessed the publication of health by the people, a similar compilation edited by newell.357 (the content of these studies will be ex­ amined in greater detail in the next section when the role of communities and community systems is examined in historical context.) if the larger undertaking was going to be successful, one or two volumes of case studies were clearly not enough. experimentation, learning and adaptation must be a continuous and ongoing process. mahler's embryonic vision was tore­ tool the who to support such an evolutionary effort. the who's role would be to help identify, cultivate, refine and propagate successful innova­ tive alternatives. this is an intensely pragmatic and experience-driven ap­ proach. let theoreticians work together with you, if you need 354. socrates litsios, primary health care: not the best of beginnings?, presented at who, at 5 (feb. 19, 2007) [hereinafter litsios, not the best of beginnings], available at http://www. who.int/global_ health_ histories/seminarslpaper06.pdf. 355. litsios, road to alma ata, supra note 351, at 718. 356. unicef-who joint comm. on health policy, alternative approaches to meeting basic health needs in devewping countries (v. djukanovic & e.p. mach eds., 1975). 357. world health oro., health by the people (kenneth w. newell ed.; 1975). 2012] global health quest for positive synergies their support, but do not let them dictate sophisticated methodologies that have not been rigorously tested .. . . the indispensable ingredient for successful health systems research is tough operational discipline com­ bined with the political guts to use information gener­ ated by the research. 358 647 re-working the political environment would be just as important as re-working the methodological orientation of health policy research. mahler went on to identify some of the mechanisms that would be necessary for effective health development a new type·ofministry of health was envisioned .... the advisory council, on which the community and sectors other than health would be represented, was one in which health development in all its intersec­ toral ramifications can be thrashed out and health economics and health ethics can be brought togeth­ er.359 such an advisory council could be a source of legitimacy, transparency and accountability, as well as a functioning mechanism for making the difficult economic, political and ethical trade-offs inherent in resource allocation decisions between competing goods. as indicated, mahler's vision had implications for the who itself. its organization and structure had to be re-oriented. who's headquarter func­ tions could be divided into two categories of tasks: one directed at generat­ ing information/knowledge and the other devoted to facilitating technical cooperation.360 who should become a neutral ground for the absorbing, distilling, synthesizing and disseminating of information that was of practi­ cal value for countries in solving their health problems. "in 1974, mahler was already advocating for a strengthened role for the regional committees and regional offices ... a new who statesmanship ... a new type of who staff members, one who was thoroughly reoriented in modem health man­ agement."361 this was an ambitious vision for how knowledge could be created and disseminated, with a focus on innovation and learning. how does this radical, process-oriented vision of the early 1970's compare to what actually happened? litsios tells a story of how this vision was corrupted and co-opted in what ultimately became the much celebrated conference and declaration of alma-ata. in his parable, the soviet repre358. litsios, road to alma ata, supra note 351, at 722. 359. id. at 722-23. 360. id. at 718. 361. id. at 729. 648 indiana health law review [vol. 9:2 sentative to the who, dr. d. d. venediktov, plays the role of the villain. it is a fact that the soviets were long pushing the concept of basic health ser­ vices at the who and they were the leading advocates for holding an inter­ national conference.362 it is also true that they did everything they could to see that the international conference was held in one of their republics, in this case, alma-ata, the largest city in kazakhstan.363 it should not surprise anyone that the soviets also sought to showcase their own health system as a model of primary health care. whether the soviet model was a good model, however, is a question open for debate. "mahler found the soviet model totally inappropriate. it was heavily centralized with little hope for change from below. it was over-medicalized. there was little to be learned from the soviet system that could be used by the developing world."364 the real objection to holding an international conference at this time, however, goes far deeper than its location or the merits of the soviet health system. if one is committed to an open, process-oriented approach to de­ veloping the meaning of primary health care, then an international confer­ ence risks sending exactly the wrong message. "venediktov thought it was possible to draw up a model of a health service system that all countries would find usefid."365 as it materialized, the conference communicated the misleading message that correct answers were in fact known and that con­ crete blueprints existed that could be readily followed and implemented. the alma-ata paper clearly was saying that enough was known to implement phc. this was a radical shift from the executive board's position paper in 1972, which called for the utilization of trial areas to test methods and means to make sure they are suited to local conditions and will enable the objectives to be attained with the resources available.366 litsios fairly speculates that the world would have been much better off if the alma-ata conference had never taken place and if the initial process­ oriented methodology had been permitted to take root. "had who, jointly with unicef, been able to record and monitor innovations, learn from them, evaluate them, and make their results widely available, an earlier and more impressive start would have been made. "367 it is difficult to argue with the abstract normative principles enshrined 362. id. at 710. 363. /d. at 715. 364. ld at 718. one can only imagine the criticisms mahler would have leveled at the u.s. model. 365. /d. at 713. 366. id at 727. 367. id. at 728. 2012] global health quest for positive synergies 649 in the declaration of alma-ata. because of this, the declaration has at­ tained near mythic status. like most myths, however, it is of little use in dealing with the practical health needs of the world's poorest and most dis­ enfranchised citizens. the notion of primary health care enshrined in the declaration of alma-ata is largely· content-less and devoid of operational meaning.368 proof of this claim lies in primary health care's chameleon­ like capacity to mean all things to all people. equally damning is the fact that the declaration lacks any internal mechanisms to guide its future de­ velopment and implementation. even the seemingly simple questions such as: "what does primary care mean?," "how can primary care be implement­ ed?'' and "where do we begin?," do not have a clear answers. the outstanding problem of how to integrate the vari­ ous vertical components that hitherto had been the pil­ lar of who's programmes was no longer being addressed. did this mean that it was no longer an im­ portant issue? as an aside, one could argue that the quick emergence of selective phc in the 1980s was not only due to external forces imposing that regres­ sive vision on who but to the fact that who had not focused on the question of integration once it started moving towards the concept ofphc.369 there was a similar failure to adopt new methodologies for research and policy planning to meet the challenges of primary health care. but more importantly, the planning tools developed by the organization were largely insensitive to the needs of phc. for example, the systems analysts then present, including myself, had not found the way to incorporate the social orientation of phc into their methodologies. newell seems to have recognized this. in his first draft for the background paper for alma-ata, written in early 1977, . . . [he commented that] ''we had misunderstood the nature of the ques­ tion we were asking and the capabilities of the scienc­ es we were looking to for assistance."370 then, as now, there was the need to develop a new science of hsd. 368. litsois, not the best of beginnings, supra note 354, at 9 ("it is not surprising that many were honestly confused about what phc was all about."). 369. id. at 8. 370. id. at 13. 650 indiana health law review [vol. 9:2 these internal failings, as much as a host of external factors,371 go far in helping to explain why the primary health care vision of·alma-ata was largely stillborn. what might this mean for psc of today? there is good reason to be­ lieve that the external international climate is more receptive today for psc than it ever was for primary health care in the 1970s and 1980s. interna­ tional politics are no longer dominated by cold war competition. there is a shared, results-oriented commitment to the international health objectives • embodied in the mdgs (a common vision). contrary to the late 1970s, the who psc has successfully cobbled together a broad political consensus and cooperative framework (positive synergies) that has brought together the leading stakeholders behind the efforts. perhaps of most significance, is the modem advent of a host of gills themselves. these institutions help provide a global health architecture, as well as funding mechanisms, to help implement the psc vision. it is also significant, that the core vision of psc, embodying its open, process-oriented methodology, has proven fairly robust in its early stages. that said, the pre-history of alma-ata suggests some reasons for con­ cern. psc is asking policy makers to openly acknowledge what most have been professionally and personally trained to deny-the existence of radical uncertainty, the reality of complex adaptive systems and the endemic failure of institutional infrastructures around the world to provide even the most basic health services. these factors are routinely and dogmatically ignored in almost all. policymaking circles (and in most respectable comers of aca­ demia). the dominant illusions ofmodemity are so strong that most tradi­ tional policy makers are largely unaware of the existence of these troubling alternative realities. as such, policy makers persistently act surprised when their well-intentioned and rationally designed models fail to generate the intended results. indeed, what is truly remarkable about psc (and the early work on primary health care) is that the broader truths about the complex real world are not only being recognized, but the appropriate methodologies and policy making processes are being designed to meet their inherent chal­ lenges. the concern is that the relentless operation of traditional politics and planning-the daily grind of business as usual-could still swamp these early efforts in much the same way that the early primary care philosophy was co-opted and corrupted by the policy and politics that resulted in the 371. primary health care faced daunting external threats and opposition. see cueto, supra note 350, at 1868-72; see also david werner, the life and death of primary health care, part of a presentation for the international people's health council at the ngo forum, united nations "global summit," (mar. 7, 1995), available at http://www.healthwrights.org/ hw/content/articles!life _and_ death_ of_phc-global_ summit_ sweden. pdf. even if the initial process-oriented visions had been maintained, one can raise serious question as to whether and in what form that vision would have survived. 2012] global heal til quest for positive synergies 651 declaration of alma-ata. people like certainty. clear, easy answers have a strong allure, no matter how wrong or misguided. funders are impatient. planners like quick results. complexity is not an aesthetically pleasing condition. almost every aspect of human psychology acts to oppose the type of policymaking experiment that lies at the heart of psc. there is no way to resist these forces unless they are expressly acknowledged and guarded against. even then, it will not be an easy task. psc will not result in a single universal victory, or even, likely, a set of statically recognizable successes. psc is initiating an incremental process to help manage a com­ plicated but hopefully not intractable set of vital health concerns. patience and a tolerance of failure will be essential components. b. connecting actions to communities-past and present legitimate enthusiasm about psc and the global fund's css frame­ work needs to be tempered with the realization that we have all been here before. ''the struggle against human oppression .. really is "the struggle between memory and forgetfulness."372 annex 1 of the 1975 alternative approaches to meeting basic health needs began by noting: as early as 1951, at a time when many developing countries were concentrating their efforts on special­ ized mass campaigns for the eradication of diseases, the director-general of the who stated in his annual report that these efforts would have only temporary results if they were not followed by the establishment of permanent health services in . rural areas to deal with the day-to-day work of the control and preven­ tion of disease and the promotion ofhealth.373 few such programs were established. the document laments how little had been accomplished in the intervening twenty years.374 sadly, nearly four decades later, very little seems to have changed. the importance of empowering local communities to take action in furtherance of improving their own health is another largely forgotten truth. a 1975 who paper promotion of national health services argued that "a series of major national efforts to develop primary health care at the com­ munity level is seen as the only way in which health services can develop rapidly and effectively ... 375 the core principles articulated in the 1975 re372. mahler, supra note 1 (internal quotation marks omitted). 373. alternative approaches to meeting basic health needs, supra note 356, at 108 (citing who official records, no. 38, 1952, p2). 374. id. at 110. 375. litsois, not the best of beginnings, supra note 354, at 1 (citing who, documents 652 indiana health law review port resonate strongly with contemporary theories ofcss: (1) for phc to be shaped 'around the life patterns of the population'; (2) for the local population to be in­ volved; (3) for 'maximum reliance on available com­ munity resources' while remaining within cost limitations; (4) for an 'integrated approach of preven­ tive, curative and promotive services for both the community and the individual'; (5) for all interven­ tions to be undertaken 'at the most peripheral practi­ cable level of the health services by the worker most simply trained for this activity'; ( 6) for other echelons of services to be designed in support of the needs of the peripheral level; and (7) for phc services to be 'fully integrated with the services of the other sectors involved in community development. '376 [vol. 9:2 while some of the terminology is different, many of the core values remain the same. these principles were further fleshed out in health by the people and alternative approaches to meeting basic health needs in developing countries.371 in terms of substance and methodology, these documents are direct precursors of the theories motivating contemporary hsd and css efforts. these documents were prepared in response to the realization amongst who leadership that while they knew that basic health services were essential and that such services must be effectively grounded in local communities, there were few good models addressing how this could be done. rejecting the strictures of traditional research methodologies, the documents searched for truth in the form of lived experiences and the power of narratives. "while some data were necessary to put the changes in mean­ ingful perspective, the authors were asked to give especial prominence to the process itself. what was wanted was a series of stories that would give life and colour to the sequence of events and decisions they considered im­ portant."378 the stories that emerged are compelling. what the stories revealed was the power of community action and community actors. there are other similarities between the examples presented. each country or area started with the forfor the 55th session of the eb, jan. 1975, document eb55/9). 376. id (quoting who, documents for the 55th session of the eb," jan. 1975, docu­ ment eb55/9). 377. health by the people, supra note 357; alternative approaches to meeting basic health needs, supra note 356. 378. health by the people, supra note 357, at xi. 2012] global health quest for positive synergies mation, reinforcement, or recognition of a local com­ munity organization. this appeared to have five rele­ vant functions. it laid down the priorities; it orga­ organized community action for problems that could not be resolved by individuals (e.g., water supply or basic sanitation); it 'controlled' the primary health care service by selecting, appointing or 'legitimizing' the primary health worker; it assisted in financing services; and it linked health actions with wider community goals. 379 653 while these commonalities are important, so are the differences. again, context-specificity is a key lesson. ''there appear to be many roads to suc­ cess. indeed, if there is a moral to this book it is that possibilities for change are open to all people but no standard method is applicable to all of them."3so alternative approaches to basic health needs employed a similar methodology, trying to break out of the conventional mold. "clearly the time has come to take a fresh look at the world's priority health problems and at alternative approaches to their solution.'.jst it was hoped that this effort would be just the beginning. 382 this was supposed to mark the be­ ginning of the end ofbusiness as usual. all of this may sound fairly idealistic, but there is nothing naive about the study's assessment of the obstacles that had to be overcome. serving as yet another indication of how little progress has been made, the discussion of various barriers being faced could easily have been written today. some of the problem lies at the national level. the report identifies a "[l]ack of clear national health policies and poor linkage of health service systems with other components of national development.''383 there are problems of planning and coordination. ''the efforts made are fragmentary, not neces­ sarily related to those of other sectors, and not directed at supporting na­ tional growth on a broad scale by fostering human wellbeing and resources."384 the report also cites a lack of "clear priorities," noting that "scant attention is given to the balance between curative, preventative, and· 379. /d. at 193. 380. /d. at xii. 381. alternative approaches to meeting basic health needs, supra note 356, at 7. 382. /d. at 8 ("it is hoped that these discussions will encourage further studies .... the emphasis is not on further development of health services as they are now organized, but rather on new ways of identifying basic health needs and of providing simple preventative and curative measures."). 383. /d. at 14. 384. id at 15. 654 lndianaiiealth law review [vol. 9~2 promotional activities and the division of resources among them. "385 oppo­ sition from the medical community is yet another obstacle. "whatever the motives of these organizations--to defend, their own interests or preserve cherished traditions-this resistance may have serious repercqssions on health plans, programmes, and policies. '.386 other problems lie at the community level. "inadequate community involvement in providing health care" is an obstacle to change .. 387 unfortu­ nately, getting increased community participation on health-related prob­ lems will not be an easy task. the report highlights a number of barriers to community participation: • in some countries a political system that does not encourage lo­ cal self-governance-a prerequisite to local involvement in health devel­ opment in general • the rigid sectoral structur~ and centralized organization of most conventional government health services • competition between the traditional system of health care already existing ~t the local level and the modern system of health care • the system of beliefs (religion, caste, etc.) of communities in peasant societies. 388 • community participation is easy to discuss at a theoretical level, but it is very difficult to implement in practice. in addition to obstacles at the social, cultural and governmental level, serious. challenges exist within the structure and operation of most health service systems themselves. again, it is interesting to note how prevalent these challenges are today. the report notes a general lack of "effective planning machinery."389 385. /d. the biggest . weakness of many health planning en­ deavors is the lack of an overall health policy to guide them, of a political will to provide the resources nec­ essary for implementation, and of an effective struc­ ture to implement the decisions.. . . . often health plans are not so designed that they fit into the coun­ try's socioeconomic development programmes and planning frequently focused on health services and not on meeting health needs. information and effec­ tive machinery for national health planning are often 386. /d. at16. 387. id 388. id at 16-17. 389. /d. at 20. 2012] global health quest for positive synergies lacking. 390 655 in an insightful recognition of the importance of a multi-disciplinary teams and approaches the report observes that "[b ]ehavioural scientists can make a considerable contribution to the planmng and management of health, but their skills are little used.'.j91 anticipating the need for systems thinking the report criticizes the "[w]eak development of the 'total systems' concept.'.j92 "health care deliv­ ery systems-public and private, national and international, curative and preventative, peripheral, intermediate and central-must be considered as a whole. "393 again, the problem is fragmentation and a lack of coherence. "the fragmentation of a· health service into disparate elements, each de­ signed to serve a small section of the population or a single purpose, mili­ tates against the goal of comprehensive and optimal utilization of limited resources. "394 this sentence could have been taken right out of the 2000 whr or the 2009 ahpsr report on systems thinking. · the same can be said of the last obstacle listed: "lack of adequate health information.'.j95 "confusion between 'statistical data' and 'infor­ mation' still reigns, with the result that many statistical services fail to pro­ vide public health administrators with the information they need for sound decision-making. "396 information is critical to any process-oriented reform initiative, but it has to be the right information. the report stresses the sig­ nificance of collecting information in terms of. what is needed to facilitate problem solving. "if national systems are to be geared to solving the real problents ·of communities, a radical reform of objectives and methods of data collection is required.'.j97 the report's recommendation is straightfor.:. ward: "information services should be recast according to the priorities of the health system and should be aimed strictly at problem-solving.''398 the theme about information and problem solving carries forward to the recommendations that the report makes to the governing bodies of the who and unicef. there was a call for the international organizations to institutionalize learning as it relates to the problems of community health and to develop a new methodology to govern a new field of research in the area. who and unicef should study in detail not only 390. id 2~21. 391. /d. at 21. 392. !d. 393. /d. 394. id at 21-22. 395. id at 25. 396. id 397. id 398. id 656 indiana health law review the innovations described in this study but also those that are occurring continuously in different parts of the world under different sponsorship; they should record and monitor them; evaluate them; make their results widely available; assist them when necessary; adapt them; build upon them; and encourage similar endeavors, even though some may present some risk in the sense that favorable outcome is not clearly pre­ dictable. 399 [vol. 9:2 this is in essence a call for the creation of a new field of policy stud­ ies and aptly anticipates much of psc's own methodology. "who and unicef should pursue research on the effects of rural and community de­ velopment of the health of people and on the role that other sectors can play in the delivery of primary health care, develop methodology for application of the findings, and assist in its implementation.'...roo one can draw a direct line between the recommendations of the 1975 alternative approaches to basic health needs and the work ofpsc and the 2010 global fund css framework. tellingly, this line would largely by­ pass the 1978 conference and declaration of alma-ata. sadly, we have lost three-and-a-half more decades. the social problems and research ques­ tions are largely the same. the obstacles and challenges remain. the needs are still pressing. the good news is that we have regained focus on what needs to be done and we have reminded ourselves of the paths that need to betaken. is there any reason to be optimistic that today's efforts under the aus­ pices of psc and the ccs framework will be any more successful than the pre-alma-ata days of the primary health ·care movement? the current agenda is ambitious. it is also going to be more medically driven, at least with respect to the hiv i aids component, than primary health care advo­ cates may have envisioned in the past. perhaps the most significant differ­ ence is the prominent role played today by ghis. these orga.nizations are helping to fill gaps in the global health architecture. they promise to in­ crease the ·capacity to effectively link the-global-to-the-national-to-the­ local. these same organizations bring funding mechanisms that were not imaginable in decade's past. this has positive and negative elements. a central component of the primary health care movement was sustainably working within the resource constraints of the various communities. com­ munities had to be involved if the effort was going to work and communi­ ties had to make hard choices regarding competing directions. while external resources expand the scope of what objectives can be accom399. id at 106. 400. id 2012] global health quest for posmve synergies 657 plished, external resources are often. accompanied by external agendas. keeping community systems authentically grounded in the community will be yet another ongoing challenge. vll. conclusion it is too early to know how the story will end history teaches that the road ahead will not be easy and will be full of unexpected challenges. that said, the roadmap being put into place looks promising. we are at least try­ ing to head in the right direction. recent efforts at health system and com­ munity system development may someday help achieve the primary health care movement's dream of health for all. socrates litsois reminisces that: at some point in the late 1960s i heard mahler put forward the. idea that only when change from below was consistent with the change that was coming from above, would health systems begin to 'swing; one of mahler's favorite terms for describing something good. it sounded good to me, which is no doubt why i remembered it, even though i wasn't quite sme what it meant at the time. the change from below would emerge from community involvement in health ser­ vices and empowerment in development, while that from above would stem from any number of possible reforms as introduced by country health program­ ming, intersectoral coordination, regionalization, health services and manpower planning, to name just a few.401 swing music, like all good jazz, taps into the ability for creative im­ provisation within established musical structures. the same ability to en­ courage improvisation, adaptation and variation within structured policy frameworks may also hold the key for future success in hsd. it is difficult for any constellation of actors to swing when confronting issues as compli­ cated as global public health, but there is reason for optimism. efforts at community system strengthening are starting to orchestrate constructive change from below. the psc is coordinating more effective change from above. a thoughtful focus on health systems and the institutional infra­ structure connecting those above with those below could start the whole system, if not swinging, at least moving step-by-step in a more positive di­ rection. 401. litsois, not the best of beginnings, supra note 354, at 11. 658 indiana health law review [vol. 9:2 epilogue: globalfund'sround 11 cancelation between the submission and publication of this article, some dramatic developments have taken place that will affect future health system devel­ opment efforts. parts n and v tell a positive story of the global fund tak­ ing a new leadership role and demonstrating a significant institutional capacity for learning and adaptation. in funding rounds 8-10, the global fund adopted an increasingly sophisticated approach to hsd. it charted new territory in its willingness to support hsd for child and maternal health in addition to aids, tuberculosis and malaria. finally, it was pio­ neering new approaches to community system strengthening (css). no international organization has been immune from the negative ef­ fects of the global financial crisis starting in 2008. "in the fund's first seven years, donors fulfilled all their commitments, with some giving more than originally pledged. almost 15 percent of donor pledges went unpaid in 2009. a year later, almost a quarter of donor pledges failed to material­ ize."402 counties were in the midst of preparing applications for the fund's eleventh round of grant disbursements when the bad news came down. "in november 2011, facing a deficit of about half a billion dollarsdue to unful­ filled donor pledges, the global fund to fight aids, tb and malaria was forced to cancel round 11 of its funding. '.4°3 according to initial reports, there would be no new funds available unti12014.404 reliable funding is essential if existing beneficiaries will continue to receive lifesaving treatments, such as antiretroviral therapy for aids. new funding rounds are also essential if the global fund's work is to be scaled­ up and expanded. each round, however, represents more than just money. the melding of effective strategies to integrate the work of ghis, hsd and css is being improved in each successive round of grant making. the can­ celation of round 11 cast a shadow of uncertainty over each of these ef­ forts. given the necessity to maintain clinical services, the work on health systems and the extension of new css initiatives may be the most immedi­ ate casualties. 405 402. laura lopez gonzalez, the first to go: how communines are being affected by the global fund crisls 12 (2012) (open society institute), available at http:/ /www.osisa.org/sites/default/files/open _debate_ 4 _-_global_ fund_ crisis_ web. pdf. 403. ld at2. 404. mara kardas-nelson, they say we can "end aids. " but who will pay for it?, nam aidsmap (july 24, 2012), available at http://www.aidsmap.com/they-say-we-can­ end-aids-but-who-will-pay-for-it/page/2448705/. 405. gonzalez, supra note 402 at 3 ("round 11 funding would have also supported community-based ngos to provide treatment literacy and adherence support; lead commu­ nity education, mobilisation and prevention efforts; and address barriers to treatment, care, and support. a new funding window would have allowed countries to fill critical gaps in hiv and tb treatment, diagnostics, and other commodities; scale-up prevention interven­ tions such as prevention of mother-to-child hiv transmission (pmtct) services and medi­ cal male circumcision (mmc); and strengthen health systems."). 2012] global health quest for positive synergies 659 the global fund has made substantial efforts to regroup. "to miti­ gate the impact of funding disruptions before a new funding model is rolled out under the new strategy, the board decided to establish a transitional funding mechanism (tfm), replacing round 11.'.406 unfortunately, during this transitional period "no stand-alone, cross-cutting [health system strengthening] hss requests will be permitted.'.4°7 the fund also intends to make substantial changes in the way it does business. this will include "a sweeping reorganization, focusing on the core business of grant manage­ ment by significantly increasing the number of staff working in that area while streamlining staffing in supporting departments and taking steps to radically improve management. ,.4os on the positive side, the fund forecasts that it will now have an additional $1.6 billion in funds to disburse during the transition period.409 · it is still unclear what the scope of organizational changes at the fund will be and in what ways it may change its fundamental approach to grant making. mark eldon-edington, the global fund director of country pro­ grammes stated that "[w]e'll probably move away from a round-based sys­ tem that comes every two years, to a series of funding windows.'.410 one thing he says will not change is the fund's commitment to civil society. "the global fund remains absolutely committed to civil society, and not solely for ideological reasons but for business reasons. if we are to deliver on our mission, we need to reach the people [that] governments can't or won't reach. civil society is the way to reach those people.'.411 no state­ ments were made about the fate of the fund's ambitious new css efforts or its commitment to hsd. during a financial crisis, it is sometimes easy to be penny wise and pound foolish. whatever organizational changes are made, it is important that key aspects of the fund's original vision and structure be retained. more than almost any other international organization, the fund was struc­ tured in a manner to facilitate its institutional capacity to learn and adapt. 406. global fund to fight aids, tuberculosis and malaria, global fund board establishes a 'transitional funding mechanism to replace round 11 and revises the appl!ca tion and approval process for renewals, announcements (de­ cember 1, 2011 ), available at http://www.theglobalfund.org/en!mediacenter/announcements/ 2011-12-0 1_ global_fund _board_ establishes _a_ transitional_funding_mechanism/. 407. !d. 408. global fund to fight aids, tuberculosis and malaria, global fund forecasts $1.6 billion in available funds for 2012-2014, news release (may 9, 20 12), available at http://www.theglobalfund.org/en!mediacenter/newsreleases/20 12-0509_global_fund_forecasts_usd_l_6_billion_in_available_funds_for_2012_2014_major _shift_retlects_strategic_choices_by_board_renewed_confidence/. 409. id 410. irin, hiv/aids: straight talk with mark eldon-edington, global fund director of country programmes, (july 24, 2012), available at http://www.plus news.org/report/95941/hiv -aids-straight-talk-with-mark-eldon-edington-global-fund­ director-of-country-programmes. 411. id 660 indiana heal1h law review [vol. 9:2 these key features need to be respected and preserved. the global fund has been far from perfect. it took ten rounds of trial and error to forge meaningful understandings of the importance of hsd and css and worka· ble mechanisms as to how these goals could be pursued. for the sake of its own long·term effectiveness, it is important that these lessons not be lost within the reformulated organizational model. not all developments in the past year are troubling. the surprising appointment of dr. jim yong kim as president of the world bank could help sustain the momentum of the who psc and renewed efforts at hsd. "dr. kim is renowned not only for his pioneerin& rights·based health care work for partners in health, but for being one of the driving forces behind the [who's] '3 by 5' initiativea global push to provide 3 million people living with hiv/aids'with antiretroviral treatment (art) by the end of 2005.'.412 kim is the first world bank president ever to appear at the inter· national aids conference. in his address, he focused on the importance of health systems development. "today, in health, the world bank's compar­ . ative advantage is in systems building. our health sector strategy is focused on supporting countries to create health systems that deliver results for the poor and that are sustainable.'.413 kim, however, seeks to join the economic expertise of the world bank with the moral passion of someone who has worked in the trenches of global public health. "i want the bank to lead the world in joining systems knowledge with clear moral values to help coun­ tries solve their toughest problems.'.414 this work must be done in the form of collaborative partnerships. "success in the aids response depends on partnerships. on a very personal level, i am committed to strengthening the world bank's multilateral alliances with unaids and the global fund; our partnerships with un technical agencies, including who and unicef; and our collaboration with pepfar and other bilaterals. moreover, strong partnership with civil society that delivers results for the poor will be a sig­ nature of my presidency.'.4ts the future of global public health remains as uncertain as its past. the cancellation of the global fund's round 11 may have taken efforts one step backwards. it is time to push to take at least two steps forward. 412. kolleen bouchane, we can end aids, buffington post (july 21, 2012), availa­ ble at http://www.huffingtonpost.comlkolleen-bouchane/international-aids-conference _ b _ 1692017 .html. 413. jim kim, ending aids and poverty, world bank group president jim yong kim remarks at the opening plenary of the international aids conference 2012 (july 22, 2012), available at http://www.worldbank.org/en/news/2012/07/22/world-bank­ group-president-jim-yong-kim~remarks-at-the-opening-plenary-international-aids­ conference-2012. 414. !d. 415. id microsoft word 1-volume xii masthead.docx healthcare corporate structure and the aca: a need for mission primacy through a new organizational paradigm? terry l. corbett, mhsa, mba, jd, llm* abstract notwithstanding passage of the affordable care act (aca) in 2010, the debate over the deontological nature of health care in the united states continues. reflecting opposing views on the issue, the provision of private (i.e., non-governmental), institutional health care in this country has evolved into a limited, binary choice of organizational forms: that is, nonprofit hospitals provide care ostensibly in order to maximize the public good; for-profit hospitals provide care as a means to maximize owner profit. over time, however, developments in medical science, technology, and business economics have resulted in increased commercialization of both organizational forms, blurring these traditional distinctions. increasingly, questions are being raised about the appropriateness of continuing to afford tax-exemption to what may be, in many instances, only nominally “nonprofit” business enterprises. the aca is expected to bring a number of systemic changes to the larger health care delivery system in which these organizations operate. among these changes is a significant increase in the number of americans with health insurance. this increase will reduce the need for charity care – the primary rationale for the initial development of nonprofit hospitals and the historical justification for their continued tax-exemption. in addition, the aca contains multiple new imperatives for improving the value, quality, efficiency, and accountability of health care services with systems-based care management applied through integrated * the author wishes to acknowledge and thank the following individuals for their time and assistance in reviewing and commenting on this article: shawn mathis, j.d., l.l.m.; h. barry holt, ph.d., j.d.; susan l. watchman, m.p.h., j.d.; and, professor john d. blum, m.h.s., j.d. http://dx.doi.org/10.18060/18961 104 indiana health law review vol. 12:1 care models. such models necessarily will require greater alignment of, and cooperation between, stakeholders in multiple delivery systems—nonprofit and for-profit alike. collectively, these changes suggest a role for a new organizational paradigm to supplement the traditional binary choice between nonprofit and for-profit corporations as a preferred vehicle for institutional health care delivery. a conceptually-new business entity that can reconcile promotion of the public good with limited profit-seeking – accomplished through a legally-enforceable organizational form that acknowledges the legitimate interests of multiple stakeholders while mandating both mission primacy and fiduciary obligation – may well be better-suited to the modern environment and new imperatives of the aca. i. introduction ..................................................................... 106 ii. the organizational history of the modern american hospital .................................................................................... 108 a. the evolution of the nonprofit tradition ............... 109 1. tax-exemption: from charity care to community benefit ................................................................................ 110 2. who owns the nonprofit hospital? .......................... 114 b. the medical-industrial complex ............................. 116 1. the impact of third-party payment ........................ 120 2. the resurgence of investor-owned, for-profit hospitals ............................................................................ 122 iii. the debate over commercialized medicine ............ 124 a. are nonprofits better, worse, or the same as for-profits? ...................................................................... 126 b. are nonprofits abusing their tax-exempt status? ............................................................................. 130 1. senator grassley’s crusade ....................................... 136 c. the deontology of health care: is it a commodity, a public good, or a right? ................................................. 137 1. the effect of emtala and the aca on americans’ right to health .................................................................. 140 d. can profit-maximization be reconciled with the public good? .................................................................... 142 iv. the affordable care act: changing the focus? .... 145 2015 healthcare corporate structure and the aca 105 a. how will new aca imperatives affect the traditional organizational forms? ................................ 149 1. industry consolidation ............................................... 150 a. the demise of physician-owned, specialty hospitals ......................................................................... 151 2. the growing importance of capital ......................... 152 3. a diminishing need for charity care ...................... 153 a. additional regulatory burdens on nonprofits ....... 155 4. cornerstone themes: quality, value, efficiency, and accountability .................................................................... 157 a. acos: alignment and integration of multiple stakeholders ................................................................... 158 b. is the aca’s focus compatible with commercialized medicine? ......................................................................... 163 v. a new organizational paradigm .................................. 165 a. the need for mission primacy ................................. 166 1. constituency statutes ............................................... 168 b. hybrid legal structures .......................................... 169 1. the flexible purpose corporation ............................ 170 2. the low-profit limited liability company (l3c) .. 171 3. the benefit corporation............................................. 172 c. the fiduciary medicine model ................................. 176 vi. conclusions ..................................................................... 178 foreword1 [t]he future of healthcare policy in the united states will continue to be characterized by tensions among market-driven, entrepreneurial forces, bureaucratic and administrative regulations, and social/ethical concerns over how best to deliver high-quality and cost-efficient medical services to all citizens.2 1 note: throughout this article, all internal footnotes in quoted material have been omitted. 2 joshua e. perry, an obituary for physician-owned specialty hospitals, 23 a.b.a. health law. 24 (2010). 106 indiana health law review vol. 12:1 i. introduction wone need do no more than open a newspaper or turn on one need do no more than open a newspaper or turn on the television to confirm the truth of the above assertion. notwithstanding the signing of the patient protection and affordable care act (the aca) on march 23, 2010, and the supreme court’s resolution of the subsequent constitutional challenge to the aca in june of 2012,3 the debate continues seemingly unabated. reduced to its simplest terms—free of the background din of partisan politics—the central issue revolves around a fundamental and still-unresolved question for the american body politic: what is the nature of health care in the united states? is it simply a “commodity” like any other product of free-market enterprise, to be consumed to the extent that those of sufficient means are able; is it instead some form of “public good” to be provided only to the extent that public agencies and/or their voluntary, private surrogates choose to do so; or, is it a “right” to which all americans have some degree of guaranteed entitlement regardless of their ability to pay? this article will not address the deontological question directly, but will instead focus on the primary mechanism through which most institutional health care in this country has come to be delivered–through what some have referred to as a “binary system”4 of nonprofit and for-profit hospitals.5 arguably, this system itself both reflects and contributes to the lack of agreement on the fundamental nature of health care in the united states. as such, the structure, function, and limitations of this binary system are worthy of examination to better inform the continuing debate and identify the best means of going forward. to this end, section ii of this article reviews the 3 richard kirsch, the politics of obamacare: health care, money, and ideology, 81 fordham l. rev. 1737, 1745 (2013). 4 katherine r. lofft, et al., is a hybrid just what the doctor ordered? evaluating the potential use of alternative company structures by healthcare enterprises, 25 a.b.a health law. 9 (2013). 5 needless to say, not all health care in this country is delivered by or through hospitals. to focus on organizational forms, however, the discussion will be limited to hospitals as the dominant institutional provider of healthcare services. 2015 healthcare corporate structure and the aca 107 organizational history of the modern american hospital through its charitable, nonprofit origins up to and through the impact of third-party medical insurance and the rise of the “medical-industrial complex.” section iii examines the differences between nonprofits and for-profits and a growing concern over nonprofits’ alleged abuse of their tax-exempt status. this concern brings into direct focus the commercialization of health care services and the traditional conflict between the organizational goals of profit seeking and pursuit of the public good. section iv then identifies and describes those provisions of the aca directed to delivery system reform, specifically addressing the act’s new imperatives for improving value, quality, efficiency, and accountability. section v follows up by asking whether these imperatives suggest the need for a new organizational paradigm that focuses on “mission primacy” to better serve the needs of multiple stakeholders in integrated delivery systems. recent efforts trending in this direction are discussed, including “constituency statutes” and various new “hybrid” legal structures. 6 lastly, a proposed “fiduciary medicine model”7 is discussed, which may well serve as an appropriate conceptual underpinning for such a new paradigm. section vi concludes with a specific suggestion for a new organizational form of “healthcare benefit corporation” that could serve to bring pursuit of the public good together with profit-seeking as the explicit and legally-enforceable dual mission of a single business enterprise.8 such proposed new entity may be a desirable supplement to (but not necessarily a replacement for) the traditional nonprofit and for-profit organizational forms—one that is particularly well suited for multi-stakeholder participation in 6 see, e.g., christen clarke, california’s flexible purpose corporation: a step forward, a step back, or no step at all?, 5 j. bus. entrepreneurship & l. 301, 307-309 (2013). 7 see dayna b. matthew, implementing american health care reform: the fiduciary imperative, 59 buff. l. rev. 715, 744-745 (2011). 8 ian kanig, sustainable capitalism through the benefit corporation: enforcing the procedural duty of consideration to protect non-shareholder interests, 64 hastings l.j. 863, 863 (2013). 108 indiana health law review vol. 12:1 development of affordable care organizations (acos) 9 and otherwise meeting the new imperatives of the aca. ii. the organizational history of the modern american hospital before reviewing the history of modern hospital organizations, some background information and a few basic facts are helpful. according to recent data from the american hospital association (aha), in excess of 2,900 of the more than 5,700 u.s. hospitals are private (i.e., nongovernmental), nonprofit facilities.10 moreover, in 2003, 68% of the 630,000 medicare-certified beds were operated by nonprofit community hospitals, 16% by for-profits, and 15% by nonfederal government facilities.11 organizationally, the principal features distinguishing for-profit from nonprofit hospitals can be summarized as follows. for-profit hospitals: are owned by stockholders, are managed by a stockholder-elected board of directors, raise capital by issuing taxable debt and/or selling equity, and either distribute their net earnings as stockholder dividends or reinvest it to increase stock value.12 by contrast, nonprofit hospitals: are not “owned” in the traditional sense,13 are managed by either a membershipselected or self-perpetuating (usually unpaid volunteer) board of directors, raise capital through charitable donations and/or the issuance of tax-exempt debt (assuming 9 see infra section iv.a.4.a. 10 bobby a. courtney, hospital tax-exemption and the community benefit standard: considerations for future policymaking, 8 ind. health l. rev. 365, 367 (2010-2011) (citing steven t. miller, comm'r, tax exempt and gov't entities, internal revenue serv., u.s. dep't of the treasury, remarks before the office of the attorney general of texas 2 (jan. 12, 2009)). 11 id. (citing cong. budget office, 109th cong., pub. no. 2707, nonprofit hospitals and the provision of community benefits 3 (2006), available at http://www.cbo.gov/ftpdocs/76xx/doc7695/12-06nonprofit.pdf.) 12 see theodore r. marmor, et al., a new look at nonprofits: health care policy in a competitive age, 3 yale j. on reg. 313, 314, n. 1 (1986). 13 see infra section ii.a.2. 2015 healthcare corporate structure and the aca 109 they have obtained tax-exempt status), and necessarily retain and reinvest all net earnings (termed the “nondistribution constraint”).14 a. the evolution of the nonprofit tradition it has been said that the modern u.s. nonprofit, taxexempt hospital resulted from a “historical anomaly.”15 that is, hospitals began as donation-supported “alms houses” where volunteers engaged in a purely welfare function – providing refuge for the very sick and dying poor who had no money to have physicians treat them at home.16 in 1880, hospitals even prohibited physicians from charging fees to hospitalized patients.17 most of these early hospitals were nonprofit by virtue of their religious affiliation.18 during this time, hospitals and physicians coexisted, largely independently, with hospitals supported by donations and government subsidies and physicians supported by fees from patients with means.19 this began to change near the end of the nineteenth century, when medical advances increasingly transformed the hospital into a primary treatment setting for the very ill that depended upon the financial support of fee-paying patients.20 many of the distinctions that previously existed between hospitals and physicians now came to distinguish for-profit from nonprofit hospitals.21 that is, for-profit hospitals typically were operated by one or more physicians and served wealthier fee-paying patients; the generally larger nonprofit hospitals continued to rely mostly on philanthropic support, but increasingly came to depend on 14 see marmor, et al., supra note 12, at n. 1. 15 george a. nation iii, non-profit charitable tax-exempt hospitals – wolves in sheep’s clothing: to increase fairness and enhance competition in health care all hospitals should be for-profit and taxable, 42 rutgers l.j. 141, 155 (2010). 16 id. 17 id. at 156. 18 marmor, et al., supra note 12, at 321. 19 id. 20 id. 21 id. 110 indiana health law review vol. 12:1 patient fees to meet the rising costs of their operations.22 by 1900, 60% of all operating hospitals were for-profit, most privately owned by one physician.23 by 1922, patient fees accounted for 65.2% of all hospital revenue, public appropriations for 17.7%, endowments for 3.6%, and donations for 5.7%.24 the period from 1900 to the1950s, however, saw significant growth in the number of nonprofit hospitals as both medical treatment and medical training became more complex, formalized, standardized, and institutionalized.25 the resulting financial pressures favored religiously affiliated nonprofits, with their ability to offer donors tax deductions and informal exemption from increasing government oversight.26 this in turn brought about a convergence of interests between nonprofit hospitals and physicians: by rejecting the for-profit hospital model, physicians lessened the likelihood of corporate control over their authority, improved their ability to control access to the medical profession, and generally enhanced the financial returns from their individual practices.27 as a result, the number of privately owned, for-profit hospitals decreased and the number of tax-exempt, nonprofit hospitals grew.28 the 1946 hospital survey and construction act (the hill-burton act) furthered this trend for the next two decades.29 1. tax-exemption: from charity care to community benefit in order to operate as a nonprofit, hospitals today must 22 see id. 23 see id. at 322. 24 nation iii, supra note 15, at 156. 25 marmor, et al., supra note 12, at 322. 26 id. 27 id. 28 see michael j. deboer, religious hospitals and the federal community benefit standard – counting religious purpose as a taxexemption factor for hospitals, 42 seton hall l. rev. 1549, 1563 (2012). 29 id. 2015 healthcare corporate structure and the aca 111 first be organized as a nonprofit corporation under state law. such status is a necessary, but not sufficient, predicate for the corporation to obtain tax exemption.30 the corporation must also qualify under current tax-exemption standards. these standards have evolved over many years from the original exemptions granted to earlier religious and charitable institutions.31 in the revenue act of 1894, congress first provided income tax exemption for “‘corporations, companies, or associations organized and conducted solely for charitable, religious, or educational purposes, including fraternal beneficiary associations.’”32 the subsequent revenue act of 1909 modified the exemption standard to include “‘any corporation or association organized and operated exclusively for religious, charitable, or education purposes, no part of the net income of which inures to the benefit of any private stockholder or individual.’”33 in 1917, congress passed the war revenue act, establishing an income tax deduction for donations to tax-exempt organizations by individuals.34 this was followed by the revenue act of 1918, in which congress established a similar estate tax deduction.35 in the revenue act of 1934, lobbying by exempt organizations was limited such that “‘no substantial part’” of their activities “could involve ‘propaganda’ or attempt[s] ‘to influence legislation.’”36 the charitable contribution deduction from income tax was extended to corporations by the revenue act of 1936.37 the revenue 30 see jeremy j. schirra, a veil of tax exemption?: a proposal for the continuation of federal tax-exempt status for “nonprofit” hospitals, 21 health matrix 231, 242 (2011). 31 see deboer, supra note 28, at 1559. 32 id. at 1560 (citing revenue act of 1894, ch. 349, § 32, 28 stat. 509, 556 (1894)). 33 id. at 1566 (quoting revenue act of 1909, ch. 6, § 38, 36 stat. 11, 112 (1909)). 34 id. at 1561 (citing war revenue act of 1917, ch. 63, § 1201(2), 40 stat. 300 (1917)). 35 id. (citing revenue act of 1918, ch. 18, § 1309, 40 stat. 1143 (1918)). 36 id. (citing revenue act of 1934, ch. 277, § 23, 48 stat. 680, 690 (1934)). 37 id. (citing revenue act of 1936, ch. 690, § 101(6), 49 stat. 1674 112 indiana health law review vol. 12:1 act of 1943 imposed a requirement that 990 forms38 be filed by tax-exempt organizations, although “publicly supported charitable organizations,” among a few others, were exempted.39 finally, in the revenue act of 1950, congress subjected tax-exempt organizations to a new “unrelated business income tax (ubit),” designed to reduce any financial advantage that such organizations might thereby obtain over their tax-paying competitors when conducting “trades and businesses” not “substantially related” to their exempt purpose.40 today, a hospital’s tax-exempt status depends on its “designation as ‘charitable’ under § 501(c)(3)” of the internal revenue code (irc).41 significantly, congress has never explicitly defined the (1936)). 38 the irs form 990 is an information form that some nonprofits have to file, disclosing such information as potential conflicts of interest, board composition, financial accountability, etc. see joanne fritz, what nonprofits need to know about form 990, about.com, http://perma.cc/9km4-bpzn. 39 see deboer, supra note 28, at 1561 (citing revenue act of 1943, ch. 63, § 117, 58 stat. 21 (1943)). 40 deboer, supra note 28, at 1561-1562 (citing revenue act of 1950, ch. 994, 64 stat. 906 (1950)). 41 courtney, supra note 10, at 368. that section provides: “§ 501. exemption from tax on corporations, certain trusts, etc. (a) exemption from taxation. an organization described in subsection (c) or (d) or section 401(a) [irc sec. 401(a)] shall be exempt from taxation under subtitle [irc sections 1 et seq.] unless such exemption is denied under section 502 or 503. . . . [(c)](3) corporations, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only if no part of its activities involve the provision of athletic facilities or equipment), or for the prevention of cruelty to children or animals, no part of the net earnings of which inures to the benefit of any private shareholder or individual, no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation (except as otherwise provided in subsection (h)), and which does not participate in, or intervene in (including the publishing or distributing of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.” nation iii, supra note 15, at 162-163 (citing i.r.c. § 501(a), (c)(3) (2004)) (emphasis added). 2015 healthcare corporate structure and the aca 113 word “charitable.”42 however, in 1956 the internal revenue service (irs) announced a “substantive rule of charitable purpose” in revenue ruling 56-185.43 this ruling, known as the “financial ability standard,” provided that tax-exempt hospitals “had to provide charity care to the extent of their ability and ‘not exclusively for those who are able and expected to pay.’”44 under this standard, hospitals could demonstrate a charitable purpose only by providing medical services free, or below cost, to the poor.45 the irs eliminated the financial ability standard in 1969, ostensibly because of a significant decrease in the number of poor (i.e., uninsured) following the enactment of medicare and medicaid in 196546 (a situation akin to that expected again under the aca). this action reportedly was prompted by hospital industry concerns over their feared inability to continue meeting irs exemption standards following reduced demand for charity care resulting from the increased availability of private and public health insurance.47 these, then, were the circumstances that led to development of the modern test for hospital tax-exempt status—the so-called “community benefit standard” promulgated by the irs in revenue ruling 69-545 issued in 1969.48 subsequently, revenue ruling 83-157 in 1983 42 courtney, supra note 10, at 368. 43 id. 44 schirra, supra note 30, at 242. 45 see id. at 243. 46 id. 47 courtney, supra note 10, at 369. 48 according to courtney: “the new ruling stated that the general law of charity considered promotion of health a charitable purpose; therefore, ‘[a] nonprofit organization whose purpose and activity are providing hospital care is promoting health and may . . . qualify as organized and operated in furtherance of a charitable purpose.’. . . revenue ruling 69-545 further identified five key factors to be considered when determining whether a hospital qualifies for exemption under section 501(c)(3), namely, does the hospital: (1) operate an emergency room open to all persons regardless of ability to pay; (2) provide care to all persons able to pay directly or through insurance; (3) serve a public interest; (4) maintain an open medical staff; and (5) use surplus revenues to improve the quality of care, facilities, medical 114 indiana health law review vol. 12:1 eliminated the requirement in 69-545 of “an emergency room open to all regardless of ability to pay,” with the result that hospitals today may qualify as charitable, tax-exempt organizations without providing any free or significantly discounted care to the indigent.49 2. who owns the nonprofit hospital? as previously noted, for-profit hospitals are owned by stockholders, whose individual shares of stock represent pro rata portions of ownership of the total net assets of the organization. nonprofit hospitals, in contrast, have no such owners by virtue of the nondistribution constraint legally imposed upon their corporate form. colloquially (and historically), nonprofit assets were often said to be “held in trust for the public good.”50 it is not surprising given nonprofit hospitals’ early philanthropic beginnings, and the subsequent requirement of a charitable purpose for tax-exemption, that the governing body of nonprofit hospitals used to be referred to as the “board of trustees” (in contradistinction to a forprofit’s “board of directors”).51 this was due in part to the fact that those wishing to create new charities would often, at least prior to the nineteenth century, choose to organize as a “charitable trust” rather than a nonprofit corporation.52 accordingly, trust law initially dominated the legal view of nonprofits, including hospitals.53 training, education, and research. determinations were to be made after consideration of ‘all of the relevant facts and circumstances in each case,’ with the absence of particular factors, or the presence of others, not necessarily being determinative.” courtney, supra note 10, at 369 (citing rev. rul. 69-545, 1969-2 c.b. 117) (emphasis added). 49 nation iii, supra note 15, at 170 (emphasis added). 50 w. cole durham & robert smith, converting a nonprofit corporation into a business corporation, religious organizations and the law § 7:29 (2013). 51 see evelyn brody, charity governance: what’s trust law got to do with it?, 80 chi.-kent l. rev. 641, 642 (2005). 52 see id. at 646. 53 see generally brody, supra note 51. “trust law does appropriately dictate specific aspects of the governance of charities, whether trust or corporate. the definition of charity set forth in the restatement of the 2015 healthcare corporate structure and the aca 115 trust law, however, has come to be an uncomfortable fit with today’s increasingly commercial nonprofit hospitals.54 conceptually, nonprofit corporations lack the “identifiable settler, beneficiaries, and trust purpose” traditionally found in charitable trust law.55 moreover, the investment and distribution activities of charitable and private trusts–the principle focus of trust law–differ substantially from “the active operation of public or quasi-public institutions.”56 from all of this, some conclude that the law governing charitable corporations today “remains an amalgam of trust law, corporate law, and tax law.”57 others characterize it simply as “neglected and thoroughly muddled.”58 what is clear is that today’s commercial nonprofit hospitals (arguably just such “quasi-public institutions”) provide a significant percentage of the country’s bed inventory, constituting charitable assets worth billions of dollars.59 the control of these charitable assets—assertedly “public goods”60—became a matter of increasing concern during the 1990s as the revenues of nonprofit hospitals decreased and their capital costs increased, motivating many of them to law of trusts controls across the board, from inheritance disputes to federal tax law. investment activity by corporate charities is easily analogized to that of trusts. when it comes to enforcing restrictions on gifts – even those made to corporate charities – regulators and courts commonly apply charitable trust doctrines. these include the authority of the state attorney general to enforce the restriction, and the application of the judicial powers of cy pres and deviation when a modification of the restriction is sought. indeed, some regulators and courts apply trust doctrine to a corporate charity seeking to change its charitable purpose.” id. at 642. 54 see generally thomas l. greaney & kathleen m. boozang, mission, margin, and trust in the nonprofit health care enterprise, 5 yale j. health pol’y, l. & ethics 1 (2005). 55 see id. at 54. 56 brody, supra note 51, at 650 (quoting edward c. halbach, jr., foreword, symposium issue on the bishop estate controversy, 21 u. haw. l. rev. i, ii (1999)). 57 thomas lee hazen & lisa love hazen, punctilios and nonprofit corporate governance – a comprehensive look at nonprofit directors’ fiduciary duties, 14 u. pa. j. bus. l. 347, 351 (2012). 58 greaney & boozang, supra note 54, at 1. 59 see id. at 3. 60 see hazen and hazen, supra note 57, at 410. 116 indiana health law review vol. 12:1 sell to or merge with for-profit entities.61 this, in turn, caused conflicts in those states where attorneys general were charged with overseeing the preservation or appropriate disposition of such community assets.62 in fact, some commentators contend that many of these transactions were fraught with “undervaluation, laxity, and in some cases, management self-dealing” that caused the loss of community assets worth millions of dollars.63 as a result, by 1998 more than twenty-five states had adopted “nonprofit conversion statutes” specifying requirements for stricter oversight by their attorneys general of such transactions.64 the problem is, while these statutes help ensure that charitable corporation assets continue to serve as public goods, the encumbrance of governmental oversight arguably makes the corporation less attractive to potential buyers or merger partners–thus lessening the commercial value of the very community assets such statutes seek to protect.65 b. the medical-industrial complex at the beginning of the 20th century, the estimated 4,000 general hospitals that had evolved from the 19th century almshouses were transforming into fee charging “business enterprises” that some 61 see generally richard j. zall & brian j. kinsella, going private: navigating state review of nonprofit hospital conversions, ahla connections (august 2013), archived at: http://perma.cc/7kpa-sjf7. 62 see greaney & boozang, supra note 54, at 4. 63 id. at 25 (citing john f. coverdale, preventing insider misappropriation of not-for-profit health care provider assets: a federal tax law prescription, 73 wash. l. rev. 1, 3-6 (1998) (describing conversions and attendant abuses); shelley a. sackett, conversion of not-for-profit health care providers: a proposal for federal guidelines on mandated charitable foundations, 10 stan. l. pol'y rev. 247, 250 (1999) (describing how and why the 1990s saw so many health care conversions); james d. standish, hospital conversion revenue: a critical analysis of present law and future proposals to reform the manner in which revenue generated from hospital conversions is employed, 15 j. contemp. health l. & pol'y 131 (1998) (explaining the impetus for so many conversions). 64 see greaney & boozang, supra note 54, at 47. 65 see greaney & boozang, supra note 54, at 79. 2015 healthcare corporate structure and the aca 117 physicians viewed as competitors to their private practices.66 many physicians responded by embracing this new model of hospital in a uniquely american way–as the proverbial “doctors’ workshop”67— where they could obtain “privileges,” remain self-employed, yet still bill their hospitalized patients for services that were now supported by the hospitals’ staff, equipment, and other resources.68 other physicians who could not or would not obtain hospital staff privileges simply undertook to develop their own hospitals, either individually or with partners, as previously noted.69 in 1912, a well-regarded surgeon and author, dr. james peter warbasse, lamented that physicians had become private tradesmen “engaged in a competitive business for profit.”70 that same year, an ama survey of 6,000 physicians “identified three ways in which entrepreneurial, market place medicine was being practiced,” with (1) surgeons paying kickbacks to general practitioners for patient referrals; (2) pharmacists and surgical device suppliers paying commissions to physicians who prescribed their products or ordered their supplies; and, (3) hospitals paying “secret commissions” of 1520% to physicians for patient referrals to their facilities.71 during the 1930s and 1940s, there were wide reports of physicians who provided no medical services being paid by diagnostic laboratories purely for patient referrals.72 in a 1954 article, fortune magazine noted the surging entrepreneurial medicine movement and labeled it a ‘persistent money mania.’ evidence supporting the claim included documented incidents of ‘clandestine fee splitting,’ the prescribing of ‘expensive but 66 perry, supra note 2, at 24-25. 67 see joshua e. perry, a mortal wound for physician-owned specialty hospitals? the legal and ethical prognosis for marketdriven, entrepreneurial medicine in the wake of 2010 health care insurance reforms, soc. sci. research network (2010) at n.59, archived at http://perma.cc/fbe2-rhyr. 68 see perry, supra note 2, at 25. 69 see id. 70 id. (citing james p. warbasse, what is the matter with medical profession? 6 long island j. med. 271-75 (1912) cited in donald w. light, ironies of success: a new history of the american health care “system,” 45 j. health & soc. behavior 1, 1 (2004)). 71 id. 72 id. http://dx.doi.org/10.2139/ssrn.1607029 118 indiana health law review vol. 12:1 needless shots,’ the taking advantage of ‘blue cross, blue shield, and other insurance plans,’ and ‘the worst abomination of all’ – the private ownership by physicians of ‘profit-making hospitals.’73 it wasn’t until the 1980s, however—the era of reagan deregulation and a time when “doctors and patients” instead became “providers and consumers”—that the public began to take note of a “new medical-industrial complex.”74 this phrase was originally coined by arnold relman, modeled after “president eisenhower’s dreaded military industrial complex of the 1950s.”75 it was frequently used by commentators during the early 1980s to describe a hospital sector expected to become increasingly dominated by a few national organizations characterized by such corporate practices as service diversification and strategic marketing.76 one such commentator was paul starr, who in 1982 published the social transformation of american medicine: the rise of a sovereign profession and the making of a vast industry.77 in his book, starr described five different ways by which hospitals would adopt “integrated control” through larger corporate organizations that were removed from the local community: 1. change from largely public and nonprofit organizations to for-profit; 2. integrate horizontally into multiinstitutional systems, shifting local control to regional and/or national offices; 73 id. (citing herrymon maurer, the md's are off their pedestal, fortune, feb. 1954, at 138). 74 see id. at 26. 75 marmor, et al., supra note 12, at 317 (citing arnold relman, the new medical-industrial complex, 303 new eng. j. med. 963 (1980)). 76 see gloria j. bazzoli, the corporatization of american hospitals, 29 j. health pol. pol’y & l. 885, 887 (2004). 77 paul starr, the social transformation of american medicine: the rise of a sovereign profession and the making of a vast industry (1982). http://dx.doi.org/10.1056/nejm198010233031703 2015 healthcare corporate structure and the aca 119 3. restructure their organizations to accommodate diversification into conglomerated enterprises operating in various health care markets; 4. integrate vertically to provide a continuum of care; and, 5. consolidate with other providers in order to concentrate ownership and control in regional and national markets.78 starr also suggested that nonprofit hospitals increasingly would come to act like for-profits, adopting “standardized management procedures, standardized accounting, and other uniform practices.”79 starr gets credit for foreseeing many important structural changes that did occur during the 1990s and early 2000s: hospitals merged at record rates, with 176 full asset mergers resulting in consolidated ownership between 1990 and 1997. these latter transactions involved nearly four hundred hospitals or about 7.2 percent of the community hospital industry. in addition, about 65 percent of hospitals were involved in some form of multihospital arrangement by 2001–either a health system or a network. in the mid-1990s, hospitals also vertically aligned with physicians through direct purchase of physician practices or contractual relationships, focusing especially on alignment with primary care physicians. many hospitals and their affiliated physicians prepared to assume the clinical and fiscal responsibility for health care delivery by developing the capacity to manage capitated contracts or by 78 id. at 429. 79 id. at 431-32. 120 indiana health law review vol. 12:1 introducing their own provider-sponsored insurance products.80 1. the impact of third-party payment it is not hyperbole to suggest that the sine qua non for the rise of the medical-industrial complex was the development and growth of third-party payment for health care. as marmor et al. have said: “the introduction of medicare and medicaid, together with the growth of private health insurance, sharply increased the flow of funds into the health industry and transformed medicine into a virtual gold-mine for commercial nonprofit as well as for-profit enterprises.”81 it is significant to note that prior to the late 1920s-early 1930s, health insurance as we know it today did not exist.82 before that time, one could only obtain coverage for loss of income due to illness– so-called “sickness insurance.”83 arguably, modern health insurance started in 1929 when a hospital insurance plan was first set up at baylor university hospital by dr. justin ford kimball.84 in the early 1930s, states passed enabling legislation that, with the assistance of the aha, led to the formal establishment of blue cross plans for hospital insurance and blue shield plans for medical insurance (the blues).85 by 1940, 10% of all americans had health insurance.86 the continued growth of the blues reinforced the previously described dominance of nonprofit hospitals during this period, due in part to blue cross’s favoring nonprofits with 80 bazzoli, supra note 76, at 889. 81 marmor, et al., supra note 12, at 328. 82 see eleanor d. kinney, for profit enterprise in health care: can it contribute to health reform?, 36 am. j.l. & med. 405, 407 (2010). 83 id. (citing harry alvin millis, sickness and insurance: a study of the sickness problem and health insurance 28-29 (1937); john e. murray, origins of american health insurance: a history of industrial sickness funds 6 (2007); nat’l indust. conference bd., sickness insurance or sickness prevention?, research report number 6 (1918)). 84 marmor, et al., supra note 12, at n.43. 85 id. at 323. 86 kinney, supra note 82, at 409. 2015 healthcare corporate structure and the aca 121 higher reimbursement rates.87 the nonprofits, and later blue cross, helped mediate physicians’ control over the delivery and financing of medical care.88 by 1946, the number of for-profit hospitals had dropped to less than 10% of total facilities.89 nonetheless, the growing number of feepaying patients brought about by the blues’ expansion of insurance coverage would contribute to an eventual resurgence of for-profit organizations.90 in 1957, the percentage of americans having health insurance had risen to 72%.91 by then, health insurance in the u.s. had largely become a private, employer-based system with two basic benefit plans modeled after the blues’ approach–“one for hospital and extended care facilities, and one for physicians and other providers of outpatient services.”92 when congress adopted the medicare program in 1965,93 it utilized essentially this same model.94 the initial implementation of medicare and medicaid further contributed to a resurgence of for-profit hospitals, as they began increasing their relative market share.95 87 see marmor, et al., supra note 12, at 324. 88 id. 89 id. 90 see id. at 324-325. 91 kinney, supra note 82, at 409. 92 id. 93 marmor, et al., supra note 12, at 325 (citing social security amendments of 1965, pub. l. no. 89-97 §§ 1801-1875, 79 stat. 286 (1965) (current version at 42 u.s.c. §§ 1395-1395zz) (1982 & supp. v 1985) (medicare act providing hospital and medical insurance for the aged, financed by federal payroll taxes); social security amendments of 1965, pub. l. no. 89-97 §§ 1901-1905, 79 stat. 343 (1965) (current version at 42 u.s.c. §§1396-1396q) (1982 & supp. v 1985) (medicaid act establishing federal matching funds for state medical assistance to the indigent)). 94 see kinney, supra note 82, at 409. 95 marmor, et al., supra note 12, at 327 (citing starr, supra note 77, at 434 (“expanding private insurance and medicare gave the financial impetus to proprietary chains.”)). 122 indiana health law review vol. 12:1 2. the resurgence of investor-owned, for-profit hospitals in the three-five year period before the enactment of medicare and medicaid, the market share of for-profit, short-term general hospitals was 5.8%; in the three-five years after the enactment, that market share rose to 6.2%.96 in addition to the rapid growth of both private and public health insurance, the increase likely was attributable to the for-profit hospitals’ more ready access to capital.97 by 1980, for-profit, short-term general hospitals accounted for 8.8% of all services provided, compared to 69.9% for nonprofits and 21.3% for public hospitals.98 significantly, between 1973 and 1982 the number of hospitals organized into forprofit systems doubled, including many that were formerly nonprofits, public hospitals, or physician-owned.99 specifically, by 1982 there were 773 hospitals that were part of 34 for-profit, investor-owned hospital systems.100 adding the additional 282 hospitals that these for-profit chains managed rather than owned at that time gave them control of an estimated 15% of all hospitals in the u.s.101 these hospitals were not randomly distributed, but rather concentrated mainly in the south, southwest, and west of the country – constituting a third to nearly half of the facilities in texas, california, florida, and tennessee.102 by 2011 the aha was reporting that 20% of all u.s. community hospitals were investor-owned.103 some current 96 id. (citing m. schlesinger, public, for-profit and nonprofit enterprises: a study of mixed industries, 76-78, 80 (1984) (unpublished doctoral dissertation, university of wisconsin at madison)). 97 see id at 326. 98 id. at 320 (citing m. schlesinger, public, for-profit and nonprofit enterprises: a study of mixed industries, 76-78, 80 (1984) (unpublished doctoral dissertation, university of wisconsin at madison)). 99 id. at 316. 100 id. at n.7. 101 see bradford h. gray, overview: origins and trends, 61 bull. n.y. acad. med. 7, 11 (1985). 102 id. 103 see thomas p. weil, privatization of hospitals: meeting divergent interests, 38 j. health care fin. 1 (2011) (citing american 2015 healthcare corporate structure and the aca 123 observers predict that–just as with the passage of medicare/medicaid–the aca will once again boost the growth of the for-profit sector104 by adding an estimated 32 million more insureds by 2019, with a corresponding $40 billion increase in hospital revenue.105 finally, it should be noted that there was extensive growth during the 1990s and 2000s in the number of forprofit, physician-owned, “specialty” hospitals.106 these facilities were developed under a broad and technical reading of the “whole hospital exception” of the stark law.107 by 2010, the u.s. house of representatives budget committee noted that approximately 265 such facilities were operating, having essentially “taken a ‘subdivision of a hospital’ and made it a freestanding hospital” in circumvention of stark’s prohibition of physician selfreferrals.108 this rapid growth brought about extensive governmental and academic scrutiny through the mid2000s, resulting in several reports and studies “revealing varying levels of adverse impacts on general community hospitals, utilization patterns, overall systemic costs, patient safety, and the equitable delivery of care to underserved populations.”109 by the end of 2010, calls were hospital association, fast facts on united states hospitals, (2011)). 104 weil, supra note 103, at 7 (noting that the major investor-owned hospital management corporations in the u.s. are “community health systems, health management associates, hospital corporation of america (hca), life point, tenet, universal health services, and vanguard.”) 105 see technical analysis on tenet healthcare and universal health: affordable care act, pr newswire, feb. 8, 2013, archived at http://perma.cc/52zn-se5b (“[f]or-profit hospital stocks . . . rallied after the supreme court upheld the healthcare reform last year.”). 106 see perry, supra note 2, at 27. 107 id. (citing 42 c.f.r. § 411.356 (c)(3)(iii) (2010)) (“this exception permitted physicians to maintain an ownership or investment interest in the facility to which they were referring their medicare patients, as long as the ‘financial interest was in the entire hospital and not merely in a distinct part or department of the hospital.’”). 108 id. (citing h.r. rep. no. 111-443, at 4 (2010)). 109 id. (citing generally u.s. gov’t accountability office, gao03-683r, specialty hospitals: information on national market share, physician ownership, and patients served, 23 (2003)); see also specialty hospital issues, centers for medicare & medicaid 124 indiana health law review vol. 12:1 strong to increase the regulation of these facilities and “reassess the ‘whole hospital exception.’”110 iii. the debate over commercialized medicine in january 1995, cardinal joseph bernadin, archbishop of chicago, said: “i am becoming increasingly concerned that our health care delivery system is rapidly commercializing itself, and in the process is abandoning core values that should always be at the heart of healthcare.”111 such sentiment reflects a continuing debate over the consequences of this country’s remarkable progress in medical science and its effect on the way hospitals (and others) have come to deliver health care services. the diametric poles of the debate can be readily seen in the work of two noted health care academics—george a. nation iii, professor of law and business at lehigh university and jill r. horwitz, assistant professor of law at university of michigan law school. professor nation contends that hospitals are “first and foremost” engaged in the “business of developing and providing health care services.”112 he argues for increased competition between and among hospitals as the surest way to achieve the highest quality health care at the lowest cost.113 he further argues that wholesale adoption of a “forprofit taxable business model” in which hospitals are “accountable to investors” is an important predicate to services, http://www.cms.gov/medicare/fraud-and-abuse /physicianselfreferral/specialty_hospital_issues.html archived at http://perma.cc/k8f4-lzds (highlighting the 18-month billing moratorium imposed on such hospitals under the medicare prescription drug, improvement, and modernization act of 2003 (mma) (pub. l. 108-173)). 110 perry, supra note 2, at 27-28. 111 nancy m. kane, tax-exempt hospitals: what is their charitable responsibility and how should it be defined and reported?, 51 st. louis u. l.j. 459, 464 (2007) (quoting david w. johnson, managing director, citigroup, presentation at harvard school of public health, financing the future: healthcare trends and their impact on capital funding (mar. 18, 2005)). 112 nation iii, supra note 15, at 180 (emphasis added). 113 id. at 207. 2015 healthcare corporate structure and the aca 125 increasing competition.114 as to nonprofits, he opines: in the best case, the mission of a modern taxexempt hospital is to keep their tax exemption and then provide the best health care at the lowest cost. in the worst case, a non-profit taxexempt hospital's mission is to keep its tax exemption in order to maximize profits and use their non-profit structure as camouflage to hide both their profit maximizing activities on behalf of doctors and administrators and/or their elitist, secretive (perhaps fraudulent) cross-subsidization of certain types of healthcare and wealth redistribution.115 by contrast, professor horwitz believes that nonprofits are more than “merely for-profits in disguise[;]” rather, they have their own distinct legal forms and benefits that distinguish their behaviors in meaningful ways from forprofits and governmental facilities:116 despite widespread beliefs to the contrary, nonprofit hospitals are not required to offer undersupplied services, which tend to be unprofitable, but they choose to do so.117 . . . . [n]onprofits prioritize some desirable goals, such as providing the right mix of medical services, over profit-maximization. individual patients, their doctors, and their insurance companies alone cannot contract for the right mix of medical services . . . so they must rely on hospitals to be trustworthy decision makers on their behalf.118 114 id. at 181. 115 id. at 180. 116 see jill r. horwitz, does nonprofit ownership matter?, 24 yale j. on reg. 139, 141 (2007). 117 id. at 191. 118 id. at 193. 126 indiana health law review vol. 12:1 . . . . nonprofits are different than for-profits. they offer different services, meet different needs, and very likely operate out of motivations of which we (and our liberal tax code) would approve.119 a. are nonprofits better, worse, or the same as for-profits? a 2006 meta-analysis conducted by the national bureau of economic research of the then-available literature examining the relationship between hospital ownership and financial performance found inconsistent and sometimes contradictory results.120 such inconsistency was attributed, in many instances, to simple differences in the studies’ theoretical frameworks, chosen variables, and other model specifications.121 another large body of literature on the relationship between hospital ownership and care quality has also yielded conflicting results, further suggesting that observed inconsistencies may derive from simple differences in analytical methods.122 similarly, a study of mediumsized, nonteaching, general hospitals in florida found no essential differences attributable to form of ownership along several measures, including “after-tax profit margins, percentages of medicare and medicaid patient days, and the dollar value of charity care and [bad] [sic] debt adjustments to revenue.”123 while the authors found “some differences 119 id. at 196. 120 see courtney, supra note 10, at 377 (citing karen eggleston et al., hospital ownership and financial performance: a quantitative research review 2 (nat'l bureau of econ. res. working paper no. 11662, 2005), archived at http://perma.cc/l7r6-n7t9). 121 id. 122 see id. at 378 (citing karen eggleston et al., hospital ownership and quality of care: what explains the different results 2 (nat'l bureau of econ. res. working paper no. 12241, 2006), archived at http://perma.cc/w9kd-9epm.) 123 frank a. sloan & robert a. vraciu, investor-owned and notfor-profit hospitals: addressing some issues, health affairs 1983, at 34, archived at http://perma.cc/v35y-87dy (noting that florida has a 33 percent market share of for-profit hospitals). 2015 healthcare corporate structure and the aca 127 in the services offered” by nonprofits versus for-profits, they general found “no pattern with regard to ‘profitable versus nonprofitable services.’”124 notwithstanding these outcomes, several researchers and commentators have reported notable differences between nonprofits and for-profits along a variety of measures. for example, weil describes several studies showing that:125 ▪ nonprofit conversions to for-profit status consistently result in a reduction in the number of employees per occupied bed.126 ▪ from 1990 through 2006, for-profits more frequently shut down emergency departments than did nonprofits.127 ▪ for-profits more frequently readmit initially discharged medicare patients.128 ▪ among rural referral centers, for-profits: treat less complicated cases and report “fewer discharges per available bed,” maintain “newer physical plant and equipment,” and generate higher cash flow margins (19.0% compared to 8.1%) than do nonprofits.129 ▪ for-profit rural referral centers achieve a “greater positive cash position” by focusing on controlling the costs of their labor.130 124 id. 125 weil, supra note 103, at 4. 126 id. (citing tami l. mark, analysis of the rationale for, and consequences of, nonprofit and for-profit ownership conversions, health services research, apr. 1999, at 83-101). 127 id. (citing renee y. hsia, arthur l. kellermann & yu-chu shen, factors associated with closures of emergency departments in the united states, 305 jama 1978 (2011)). 128 id. 129 id. (citing michael j. mccue & preethy nayar, a financial ratio analysis of for-profit and non-profit rural referral centers, 25 j. rural health 314 (2009)). 130 id. (citing michael j. mccue & preethy nayar, a financial ratio analysis of for-profit and non-profit rural referral centers, 25 j. rural health 314 (2009)). http://dx.doi.org/10.1001/jama.2011.952 http://dx.doi.org/10.1111/j.1748-0361.2009.00236.x http://dx.doi.org/10.1111/j.1748-0361.2009.00236.x 128 indiana health law review vol. 12:1 similarly, hellinger cites several articles reporting differences attributable to organizational form:131 ▪ costs and efficiency results predominantly favor nonprofits, particularly “[a]mong the most sophisticated models of technical efficiency.”132 ▪ after “adjusting for potential confounders,” patients in nonprofits have been found to have “uniformly lower probabilities of dying in the hospital” than patients in forprofits.133 ▪ a study by the u.s. prospective payment assessment commission determined that nonprofits provide uncompensated care equivalent to 4.5% of revenues, compared to 4.0% of revenues provided by for-profits.134 ▪ several other studies also found that forprofits provide less uncompensated care than nonprofits.135 ▪ nonprofits are more likely to provide unprofitable services than for-profits.136 131 fred j. hellinger, tax-exempt hospitals and community benefits: a review of state reporting requirements, 34 j. health pol. pol’y & l. 37, 45-47 (2009). 132 id. at 45 (citing mark schlesinger & bradford h. gray, how nonprofits matter in american medicine, and what to do about it. health affairs (july 2006), archived at http://perma.cc/d8j3-jl7x). 133 id. (citing p. j. devereaux et al., a systematic review and metaanalysis of studies comparing mortality rates of private for-profit and private not-for-profit hospitals, 166 canadian med. ass’n j. 1399, 1399-1406 (2002)). 134 id. at 46 (citing u.s. prospective payment assessment comm’n, medicare and the american health care system, report to congress (1996)). 135 id. (citing kamal r. desai et al., public hospitals: privatization and uncompensated care, health affairs (mar./apr. 2000), archived at http://perma.cc/7j46-um7w). 136 id. at 47 (citing mark schlesinger & bradford h. gray, how nonprofits matter in american medicine, and what to do about it, health affairs (july 2006), archived at http://perma.cc/d8j3-jl7x). 2015 healthcare corporate structure and the aca 129 ▪ a congressional budget office (cbo) study found that nonprofits were more likely to provide the following types of specific unprofitable services: labor and delivery services, emergency room care, high-level trauma care, and intensive care for burns.137 notwithstanding the above findings, hellinger also identifies a number of articles reporting no, or at most equivocal, evidence of differences—some in the very same articles, but with regard to different measures.138 the apparent willingness of nonprofits to provide unprofitable services when and where for-profits don’t serves as the primary basis for horwitz to assert that nonprofits are motivated more often to act in the public interest.139 she goes on to suggest that nonprofits accordingly are more likely to consider quality over profit— thereby “providing the mix of services that patients would demand if they could.”140 she sees this provision of services “with variable profits” as strongly supporting an “objectives theory” of hospital behavior.141 that is to say, hospitals behave differently because they have different objectives. it 137 id. (citing u.s. congressional budget office, nonprofit hospitals and the provision of community benefits (2006)). 138 id. at 45-47 (citing frank a. sloan, not-for-profit ownership and hospital behavior, in handbook of health economics, (a. j. culyer & j. p. newhouse eds., 2000); the tax-exempt hospital sector: hearing before the h. comm. on ways and means, 109th cong. 142-155 (2005) (joint statement of mark schlesinger & bradford h. gray, urban institute); citing mark schlesinger & bradford h. gray, how nonprofits matter in american medicine, and what to do about it, health affairs (july 2006), archived at http://perma.cc/d8j3-jl7x; citing emmett b. keeler et al., hospital characteristics and quality of care, 268 jama 1709 (1992); jeannette rogowski et al., hospital competition, managed care, and mortality after hospitalization for medical conditions, 42 health servs. research 682 (2007); u.s. congressional budget office (cbo), nonprofit hospitals and the provision of community benefits (2006), archived at http://perma.cc/gk5x-d5ga). 139 see horwitz, supra note 116, at 139. 140 see id. at 193-194. 141 see id. at 175. http://dx.doi.org/10.1001/jama.1992.03490130097037 130 indiana health law review vol. 12:1 takes no great theoretical reach to conclude that forprofits—motivated primarily by profit-maximization—are more likely to “avoid unprofitable patients” than nonprofits.142 this perception, that nonprofit hospitals are motivated more often to act in the public interest, has resulted in what many commentators refer to as the “halo effect”143—the propensity of people to see nonprofits as more trustworthy than for-profits. a less metaphorical explanation can be found in “information asymmetries theory.” according to this theory, “information asymmetries” exist “when one party to a transaction possesses information that another party does not,” and/or “when the purchaser of a good or service cannot easily ascertain the quality of the good or service.”144 it is clear that in the hospital-patient relationship, both conditions pertain—hence horwitz’s emphasis on the relevance of patient trust. such trust, however, has come under ever more strain as both forms of health care organization display increasingly adverse effects of the industry’s growing commercialization.145 b. are nonprofits abusing their tax-exempt status? according to former irs commissioner mark w. everson: what we have seen since 1969 has been a convergence of practices between the for-profit and nonprofit hospital sectors, rendering it 142 see id. at 157. 143 see peter molk, reforming nonprofit exemption requirements, 17 fordham j. corp. & fin. l. 475, 532 (2012) (citing burton a. weisbrod, the nonprofit economy vii (1988) (noting that some people think certain nonprofits are “safer” than for-profits); see also hearing on gov't waste and tax abuses by gov't and nonprofit entities before the subcomm. on procurement, taxation and tourism of the h. comm. on small business, 103d cong. 1 (1994) (statement of rep. james d. santini, chairman, business coalition for fair competition), reprinted in 94 tax notes today, 117-25 (june 17, 1994) (noting the “halo advantage” nonprofits possess when dealing with the public)). 144 id. at 482-483. 145 see marmor, et al., supra note 12, at 343. 2015 healthcare corporate structure and the aca 131 increasingly difficult to differentiate for-profit from non-profit health care providers. in our review of tax-exempt hospitals, some of the issues we are finding include complex joint ventures with profit-making companies, excessive executive compensation, operating for the benefit of private interest rather than the public good, unrelated business income and employment taxes.146 these commercialization effects are coming under increasing scrutiny and, in some cases, direct attack. numerous studies, reports, and articles have come out over the last ten years documenting various “bad acts” by taxexempt, nonprofit hospitals.147 in most instances, these acts are not illegal, but are rather in the nature of behavior “that falls below broadly held social expectations of charitable hospitals and health systems.”148 moreover, “legal” does not mean “harmless”—it was reported in 2009 that most personal bankruptcies in the united states are caused by medical bills that cannot be paid.149 examples of bad behavior on the part of nonprofit hospitals include: failing to disclose the availability of medicaid and/or institutional free care or charity care programs;150 the use of predatory and aggressive collection tactics;151 charging indigent and uninsured patients more than what the hospital routinely accepts as payment in full 146 hellinger, supra note 131, at 38 (citing, the tax-exempt hospital sector: hearing before the comm. on ways and means u.s. house of representatives, 109th cong., serial no. 109-17, (may 26, 2005) (statement of mark everson, comm’r of the internal revenue serv.). 147 see amanda w. thai, is senator grassley our savior?: the crusade against “charitable” hospitals attacking patients for unpaid bills, 96 iowa l. rev. 761, 771 (2011). 148 kane, supra note 111, at 470. 149 see thai, supra note 147, at 763 (citing catherine arnst, study links medical costs and personal bankruptcy, bus. wk., (june 4, 2009), archived at http://perma.cc/5xbt-fvhx. 150 see id. at 770. 151 id. at 770-771. 132 indiana health law review vol. 12:1 from insurance plans;152 and, arguably worst of all, bringing suit against former patients for bad debt.153 consider two particularly egregious examples: ▪ “in 2002, yale-new haven hospital, the largest charitable healthcare provider in new haven, connecticut, filed 426 lawsuits against patients.”154 ▪ “up until very recently, forty percent of the total judgments in roanoke city general district court—roughly 33,000 judgments since 2003—resulted from claims by southwest-virginian 501(c)(3) carilion clinic. in one year, carilion sued 9888 patients, garnished the wages of 5478 people, and placed liens on 3920 homes.”155 by the mid-2000s approximately seventy federal class action suits alleging excessive charges and overly aggressive collection activities had been brought against individual nonprofits and hospital systems, as well as the american hospital association.156 while these federal suits largely failed,157 many plaintiffs were more successful in state courts proceeding under broad consumer-fraud statutes.158 as a consequence, plaintiffs’ lawyers obtained settlements from major nonprofit hospital systems in several states, 152 see id. at 769-770. 153 see id. at 771. 154 id. (citing conn. ctr. for a new econ., uncharitable care: yale-new haven hospital's charity care and collections practices 19 (2003), archived at http://perma.cc/u92u-43vp.). 155 id. (citing laurence hammack, carilion cases dominate general district docket, roanoke times, (sept. 14, 2008), archived at http://perma.cc/jtp9-jugb). 156 horwitz, supra note 116, at 155. 157 ostensibly because of weak tax-exemption arguments predicated on the idea that “the uninsured were third-party beneficiaries of implied contracts between the hospitals and the federal and state government[s] . . .” id. 158 see joseph goldstein, exerting their patients, a.b.a. j., may 2009. 2015 healthcare corporate structure and the aca 133 including: california, missouri, and illinois.159 further, these successes began motivating state legislatures to propose bills governing hospitals’ billing practices and charity care policies.160 beyond financial harm to individuals, other practices have also raised questions about the appropriateness of nonprofit hospitals’ continued tax-exempt status. one such concern is nonprofit ceo salaries: “a recent study of fourteen tax-exempt hospitals in florida's tampa bay area revealed that the average compensation for chief executives at those hospitals was about $876,000—drastically higher than the national average of $490,000.”161 many believe that such salaries, if justifiable at all, should depend more on hospital executives’ demonstrated ability to meet their communities’ needs rather than their organizations’ success at profit making.162 another concern relates to the accuracy of nonprofit hospitals’ financial reporting of charity care—mandated in response to regulatory pressures against excessive profit.163 for example, after surveying 544 hospitals the irs noted that some facilities apparently overstate their level of uncompensated care by reporting their services at “retail price”164 rather than “cost.”165 a third concern is the perception that many nonprofit 159 id. 160 see kane, supra note 111, at 461. 161 thai, supra note 147, at 782 (citing kris hundley, economic downturn? not for these tampa bay nonprofit hospital chiefs, st. petersburg times, (jan. 31, 2010), archived at http://perma.cc/2ehgyv8m). 162 see id. 163 see peter cram, et al., uncompensated care provided by forprofit, not-for-profit, and government owned hospitals, bmc health services research 2010, 10:90 (2010), available at http://www.biomedcentral.com/1472-6963/10/90. 164 most hospitals establish a price list—the so-called “chargemaster”—which essentially represents “the hospital’s initial bargaining position from which insurers negotiate down.” these are also the prices that some hospitals have charged “indigent and uninsured patients,” as previously noted. see goldstein, supra note 158, at 19. 165 see goldstein, supra note 158, at 20. http://dx.doi.org/10.1186/1472-6963-10-90 134 indiana health law review vol. 12:1 hospitals are taking advantage of their comparatively lower cost of capital through the tax-exempt debt markets “at the expense of community benefit.”166 that is, in a practice called “tax arbitrage,” some nonprofits have financed their capital projects through tax-exempt bond debt instead of using their own available investment assets.167 according to kane: one study found that over half the tax-exempt debt held by hospitals in 1996 could have been eliminated if hospitals had used their ‘endowment assets’ before borrowing. the same study also found that both endowment assets and tax-exempt bonds are concentrated in a minority of hospitals, indicating that tax subsidies are benefiting cash-rich hospitals while not helping those cash-poor hospitals most in need of outside financing.168 finally, the biggest concern is undoubtedly the amount of money that government at all levels is losing in foregone tax revenue. in 2002, the value to u.s. nonprofit hospitals of major federal, state, and local tax exemptions was estimated to be approximately $12.6 billion.169 this included: “$2.5 billion in federal corporate income taxexemptions, $1.8 billion in federal tax-exempt-bond financing, $1.8 billion in charitable contributions (federal), 166 see paula h. song, jeffrey s. mccullough & kristin l. reiter, the role of non-operating income in community benefit provision by not-for-profit hospitals, 39 no. 3 j. health care fin. 59, 60 (2013) (citing congressional budget office, nonprofit hospitals and tax arbitrage (2006), archived at http://perma.cc/ufc7-hxpf). 167 e.g., “unrestricted marketable securities that were earned through unrestricted gifts, investment income, retained earnings, and funded depreciation.” kane, supra note 111, at 466. 168 id. (citing william m. gentry, debt, investment, and endowment accumulation: the case of not-for-profit hospitals, 21 j. of health econ. 845, 871 (2002)). 169 courtney, supra note 10, at 376 (citing cong. budget office, 109th cong., pub. no. 2707, nonprofit hospitals and the provision of community benefits 5 (2006), archived at http://perma.cc/34cevrxt). http://dx.doi.org/10.1016/s0167-6296(02)00056-5 2015 healthcare corporate structure and the aca 135 $500 million in state corporate income tax exemptions, $2.8 billion in state and local sales tax exemptions, and $3.1 billion in local property tax exemptions.”170 hellinger contends that (1) even though there is some evidence that nonprofits provide more unprofitable services and more uncompensated care than for-profits, and (2) even though 80% of nonprofits’ uncompensated care exceeds the value of their tax exemption, these efforts are insufficient to justify such facilities’ continued tax-exempt status.171 as one example reflecting this growing opinion, the supreme court of illinois ruled in march 2010 that provena covenant medical center in urbana had failed to provide charity care sufficient to justify its exemption from state property taxes.172 another example is the current fight between the mayor of pittsburgh and the university of pittsburgh medical center (upmc).173 pointing to upmc’s 2012 ceo compensation exceeding $6 million, and the more than $1 million paid to each of more than twenty other upmc executives that same year, the city has sued the taxexempt nonprofit to force it to pay property and payroll taxes—charging that “the health care system operates more like a for-profit corporation than a charitable organization dedicated to the local community.”174 as a result of a growing number of such examples, several states have passed legislation either requiring or encouraging additional “community benefit reporting” by hospitals.175 170 id. 171 see hellinger, supra note 131, at 55-56. 172 kinney, supra note 82, at 427 (citing provena covenant med. ctr. v. dep't. of revenue, 2010 wl 966858 (ill. mar. 18, 2010), aff'g, 384 ill.app.3d 734, 894 n.e.2d 452 (2009); see also utah county v. intermountain health care, inc., 709 p.2d 265, 269 (utah 1985)). 173 see kate picket, a tax fight in pittsburgh and the future of non-profit hospitals nationwide, time swampland, june 10, 2013, archived at http://perma.cc/tk5x-abs2. 174 id. 175 see courtney, supra note 10, at 372 (citing cal. health & safety code §§ 127350, 127355 (lexisnexis 2010), idaho code ann. § 63-602d (2010); 210 ill. comp. stat. ann. 76/15, 76/20 (lexisnexis 2010); ind. stat. ann. §§ 16-21-9-4-16-21-0-7 (lexisnexis 2010); md. code ann., health-gen. § 19-303 (lexisnexis 2010); n.h. rev. stat. ann. §§ 7:32-e7:32-g (lexisnexis 2010); n.y. pub. health law § 2803-l (consul. 136 indiana health law review vol. 12:1 1. senator grassley’s crusade in 2005, senator charles e. grassley (iowa), chairman of the senate finance committee, and representative bill thomas (california), chairman of the house ways and means committee, began to question whether the value nonprofits receive from their tax-exemption exceeds the benefit communities receive in return.176 specifically, grassley questioned the appropriateness of “hospital executive compensation levels, joint ventures with commercial organizations, and hospital for-profit subsidiaries.”177 in may of that year, senator grassley sent letters to ten large nonprofit hospitals, asking that they “account for their charitable activities.”178 in june 2006, the senator asked the irs to report on its efforts to ensure that nonprofits were complying with federal tax rules.179 the irs subsequently asked more than 550 tax-exempt, nonprofit hospitals to complete a compliance questionnaire.180 in july of that year, grassley “questioned treasury secretary nominee eric solomon about his commitment to regulating tax-exempt hospitals, in particular mandating charity care and community benefit requirements.”181 the senate finance committee considered a number of health care reform policy options distributed by senators 2010)). 176 kane, supra note 111, at 459-460. 177 id. at 460 (citing letter from charles e. grassley, chairman, committee on finance, u.s. senate, to richard j. davidson, president, american hospital association (mar. 8, 2006)). 178 courtney, supra note 10, at 375 (citing press release, grassley asks non-profit hospitals to account for activities related to their tax-exempt status (may 27, 2005), archived at http://perma.cc/jy5at6u7). 179 horwitz, supra note 116, at 154 (citing sen. grassley asks irs to step up oversight of health care nonprofits, 14 health care pol'y rep. (bna) no. 23, at 759 (june 5, 2006)). 180 id. at 154-155 (citing robert pear, i.r.s. checking compliance by tax-exempt hospitals, n.y. times, june 19, 2006, at a15). 181 id. at 155 (citing grassley seeks assurances from solomon on charity hospitals' tax-exempt status, daily tax rep. (bna) no. 136, at g1 (july 17, 2006)). 2015 healthcare corporate structure and the aca 137 grassley and max baucus in may 2009.182 these options were released as proposed legislation entitled “america’s healthy future act of 2009” on september 22, 2009 and included “requirements for community needs assessments, financial assistance policies, charge limitations, collection policies, as well as reporting and disclosure.”183 even though congress never passed this legislation, most of senator grassley’s proposals were later incorporated into the aca, as discussed in section iv(a)(3)(a) infra.184 c. the deontology of health care: is it a commodity, a public good, or a right? if health care is a commodity like all others, then there is no basis for characterizing much of the above-described hospital conduct as bad acts. alternatively, if health care is a public good—in either the generic or economic sense of the word—then the public is justified in expecting better behavior from nonprofits as the equitable quid pro quo for tax-exemption. if, however, health care is a right to which all americans are entitled regardless of their ability to pay, then one can fairly ask whether such services can ever be reliably and ethically provided by any institutional provider that is primarily motivated by profit, regardless of that provider’s nominal organizational form. reflective of the world view that health care is just another commodity are the reported comments of john mcdaniel, executive director of american medical international’s st. jude hospital in new orleans, justifying his organization’s tough collection practices: “grocery stores don't have to provide food to the indigent."185 182 courtney, supra note 10, at 375 (citing s. fin. comm., 111th cong., financing comprehensive health care reform: proposed health system savings and revenue options (comm. print 2009)). 183 id. at 376 (citing america's healthy future act of 2009, s.1796, 111th cong. (2009), available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=111_cong_bills&docid=f:s1796pcs.txt.pdf). 184 thai, supra note 147, at 763 (citing patient protection and affordable care act §§ 9001-9023 (adopting s. 1796 §§ 6000-6023)). 185 see marmor, et al., supra note 12, at 344-345 (citing grady, the cruel price of cutting medical expenses, discover, may, 1986, at 25, 138 indiana health law review vol. 12:1 few scholars of health care today would subscribe to mr. mcdaniel’s view. as marmor, et al. put it: this casual remark is terribly revealing in its acceptance of this business-like aspect of health care. this acceptance reflects a guiltless dismissal of centuries of concern that the care of the sick imposes special obligations on both the givers of care and the community as a whole. of equal concern is the behavior of the nonprofit institutions that carefully nurture reputations for community service while, at the same time, transferring costly cases to the local county hospitals. the relative triumph of commercialism and the long decline of professional authority mark a major shift in the character of american medicine.186 the idea of health care as a public good is often used in two different senses: first, is in the generic sense of “public benefit”—the provision of which is deemed to be the justification for granting nonprofit providers taxexemption;187 second, is in the economic sense of goods that are both “nonrival and nonexcludable.”188 in this context, such terms are taken to mean goods that can be consumed simultaneously by more than one person at the same level (i.e., nonrival), and that cannot be readily excluded from anyone’s consumption (i.e., nonexcludable).189 thus, “once the good is provided, all individuals can consume it regardless of their contribution to the good”—giving rise to the so-called “free-rider problem.”190 these characteristics are said to result “in an inefficiently low observable demand for the good (in terms of who is willing to pay for it), and 40). 186 id. at 345. 187 see hazen & hazen, supra note 57, at 365-366. 188 see horwitz, supra note 116, at 194. 189 see molk, supra note 143, at 480. 190 see id. 2015 healthcare corporate structure and the aca 139 hence a socially suboptimal under-provision of the good.”191 under a “public goods theory,” then, to the extent that government does not provide sufficient quantities of the good, nonprofits arise to do so—again, the arguable justification for their tax-exemption.192 the point can be illustrated by trauma centers: because they are expensive to develop and typically lose a lot of money, they are rarely established by for-profit hospital organizations.193 last is the politically charged idea of health care as a right or entitlement. in view of the complexity of the issue, only a limited number of observations will be offered here. during the 1960s, the united nations (un) developed the international covenant on economic, social and cultural rights (icescr)—an international covenant under the un universal declaration of human rights (udhr), positing in its article 12 a “human right to health” that includes ‘“the enjoyment of the highest attainable standard of physical and mental health.’”194 included in the “core content” of the right to health, as outlined in general comment 14 to the icescr, are “essential primary health care, minimum essential and nutritious food, sanitation, safe and potable water, and essential drugs.”195 similarly, the constitution of the world health organization (who) “states a right to the ‘highest attainable standard of health’ and defines health broadly as ‘a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.’”196 in addition, several other 191 id. at 481 (citing james m. buchanan, collected works of james m. buchanan: the demand and supply of public goods 12-15 (1999)). 192 see id. at 481-482. 193 see horwitz, supra note 116, at 194. 194 eleanor d. kinney, realizing the international human right to health: the challenge of for profit health care, 113 w. va. l. rev. 49, 50 (2010) (citing international covenant on economic, social and cultural rights, g.a. res. 2200 (xxi) a, u.n. doc. a/6316 at 51 (dec. 16, 1966)). 195 id. at 51 (citing the right to health, world health org (nov. 2013), archived at http://perma.cc/f2zx-egpk). 196 id. at 53 (citing constitution of the world health organization, opened for signature, july 22, 1946, 62 stat. 6279, 14 u.n.t.s. 185 (entered into force apr. 7, 1948)). 140 indiana health law review vol. 12:1 international authorities and regional treaties also address a “human right to health” and prohibit conduct by governments detrimental thereto.197 1. the effect of emtala and the aca on americans’ right to health it is obvious that the body politic in the united states continues to debate whether americans have, need, or want a “right to health” as recognized in many other parts of the world. nonetheless, it is instructive to consider the degree to which the emergency medical treatment and active labor act (emtala) and the aca together are moving the country in that direction. in 1986, congress enacted emtala in response to a growing problem with “patient dumping.”198 prior to that time, there was no uniform statutory or common law requirement for hospitals to treat anyone.199 as a result, it was not unusual for hospitals to “dump” patients who presented at the emergency room with no ability to pay by simply refusing to treat them or by transferring them elsewhere.200 this problem appeared to worsen following implementation of the medicare prospective payment system in 1983.201 in response, congress sought to take steps to protect “traditional community responsibilities” and “historic standards.”202 emtala requires those hospitals that have an emergency room and also participate in medicare203 to provide for “appropriate medical screening” of all persons (regardless of their payment status) who present for examination or treatment of a medical condition, 197 id. at 52. 198 alexa e. welzien, balancing emtala’s duty to stabilize hospital inpatients and cms’s regulations in the midst of a struggling hospital industry, 23 no. 6 health law. 21, 21 (2011). 199 see id. at 23. 200 id. at 21. 201 id. at 23. 202 see id. (citing h.r. rep. no. 99-241, at 27 (1985), reprinted in 1986 u.s.c.c.a.n. 579, 605.). 203 id. at 21. medicare participation, as a practical matter, includes virtually all hospitals. 2015 healthcare corporate structure and the aca 141 in order to “determine whether a medical emergency” exists.204 if an emergency medical condition is found, the hospital must provide such further examination and treatment as necessary to stabilize the condition prior to discharging or transferring the patient to an appropriate, alternate facility.205 that is not to say, however, that this treatment is provided for free or that the patient does not remain financially responsible for the costs of the services they receive. thus, while emtala ensures that patients having medical emergencies will not “die on the doorsteps of the hospital,” it does not shield them from some of the harsh collection efforts previously described or prevent them from being forced into bankruptcy over unpaid medical bills. this is where the aca now comes into play in two ways. first, the aca’s “individual mandate”—the requirement that all “applicable individuals” maintain “minimum essential” health insurance coverage206—is expected to add 32 million more insureds by 2019.207 second, the aca’s new “community benefit requirements”208 now prohibit nonprofit hospitals from charging uninsured emergency patients more than they charge insured patients, and engaging in “extraordinary billing and collection actions without first making ‘reasonable efforts to determine whether the individual is eligible for assistance under the [hospital's] financial assistance policy.’”209 the combined effect of emtala and these aca provisions thus goes a long way toward ensuring that all americans can and will receive at least emergency health care services when needed. however, a “human right to health” for everyone that includes ‘“the enjoyment of the highest attainable standard of physical and mental health” remains another matter. 204 see id. at 21 (citing 42 u.s.c. § 1395dd(a) (2014)). 205 see id, (citing 42 u.s.c. § 1395dd(b) (2014)). 206 see 42 u.s.c. § 18091 (2014). 207 see supra section ii(b)(2). 208 see infra detailed discussion in section iv(a)(3)(a). 209 see welzien, supra note 198, at 30 (citing 26 u.s.c. § 501(r)(3)(6) (2014). 142 indiana health law review vol. 12:1 d. can profit-maximization be reconciled with the public good? “no man can serve two masters: for either he will hate the one, and love the other; or else he will hold to the one, and despise the other. ye cannot serve god and mammon.”210 because they do not receive the financial advantages of tax-exemption, for-profit hospitals do not have a reciprocal obligation to provide community benefit. moreover, nonprofits that joint venture with for-profit entities—even if ostensibly done to expand services, increase uncompensated care, or otherwise increase community benefit—actually risk losing their tax-exempt status.211 in fact, prior to the early 1980s the irs viewed all such joint ventures as per se improper.212 in 1983, the irs modified its position by adopting a new two-pronged test: (1) “the ‘charitable purpose’ test,” examining whether or not the venture furthers the nonprofit’s tax-exempt purpose; and, (2) “the ‘private benefit’ test,” evaluating whether the venture operates exclusively for the nonprofit’s charitable purpose and/or “results in more than incidental benefit to the forprofit partner.”213 it is obvious, however, that the irs still perceives an inherent conflict between the pursuit of public good and profit seeking. of course, for-profits can and do provide community benefit. indeed, as previously noted, some commentators maintain that “investor-owned system hospitals and not-for profit hospitals are virtually identical in terms of . . . the dollar value of charity care.”214 be this the case or not, it is clear that many for-profits will engage in community benefit 210 justin blount & kwabena offei-danso, the benefit corporation: a questionable solution to a non-existent problem, 44 st. mary’s l. j. 617, 618 (2013) (citing matthew 6:24 (king james)). 211 see gail rebecca floyd, nonprofit joint ventures and community benefit: a new approach, 58 fed. law. june 2011, at 23, 25 (2011). 212 see id. 213 id. (citing i.r.s., gen. couns. mem. 39,005 (june 28, 1983)). 214 sloan & vraciu, supra note 123 at 25. 2015 healthcare corporate structure and the aca 143 activities, if for no reason other than to promote their informed self-interest—that is, to appear as good corporate citizens and remain competitive in nonprofit-dominated markets. it is equally clear that nonprofits cannot operate in today’s increasingly commercialized health care environment without a steady eye on the financial bottom line. as with many things, it all seems to be a question of degree and thus subject to continuing controversy. 1. the legal duties of hospital governing bodies the controversy is perpetuated in part by the law of corporate governance as it has evolved in this country. kanig describes it well: during the great depression, a famous exchange between adolf augustus berle and edwin merrick dodd on the pages of the harvard law review phrased the question thusly: are corporations solely responsible to private ownership interests, or do they also possess obligations to benefit the general public welfare? lines were drawn in the intellectual sand between berle's ‘shareholder primacy’ theory and dodd's ‘stakeholder theory’ of corporate governance—the former embracing corporations as private property, the latter as an integral component of any comprehensive system of social welfare. the future of corporate law and the culture of american business were at stake. . . . [s]hareholder primacy theory triumphed in the courts, and the ‘shareholder wealth maximization norm,’ which made the promotion of shareholder returns the exclusive mandate of corporate [decision-making] [sic], was unshakably ingrained into the corporate ethos. the effects of this normative choice were enormous.215 215 kanig, supra note 8, at 870 (emphasis added). 144 indiana health law review vol. 12:1 kanig goes on to note that “the victory of shareholder wealth maximization had already been presaged by the seminal decision of dodge v. ford motor company” in 1919, wherein the michigan supreme court held: a business corporation is organized and carried on primarily for the profit of the stockholders. the powers of the directors are to be employed for that end. the discretion of directors is to be exercised in the choice of means to attain that end, and does not extend to a change in the end itself, to the reduction of profits, or to the nondistribution of profits among stockholders in order to devote them to other purposes.216 under the law, as it still exists today, few would question the potential liability of a for-profit director who failed to act in the shareholders’ best interest by not pursing profit on their behalf, or one who otherwise subordinated shareholders’ interests to some other purpose, be it public or private. the primary legal duty of a nonprofit director stands in stark contrast. at the outset and as previously noted, nonprofits have no shareholders whose wealth must be maximized. rather, any profits earned by the charitable, nonprofit corporation must be used only in ways that further the charitable interest of the organization.217 this is the charitable, nonprofit corporation’s raison d’être and the corresponding mandate of such corporation’s directors. it should be noted that all corporate directors—for-profit and nonprofit alike—are subject to certain legally recognized fiduciary duties. these generally include a “duty of care,” a “duty of loyalty,” a “duty of good faith,” and a “duty of obedience.”218 of these, the duty of obedience is 216 id. at 877 (quoting dodge v. ford motor co., 170 n.w. 668, 684 (mich. 1919) (emphasis added)). 217 id. at 884. 218 see hazen & hazen, supra note 57, at 355. 2015 healthcare corporate structure and the aca 145 particularly relevant to nonprofit directors since it specifically involves fealty to the organization’s mission.219 from this, some have argued that charitable, nonprofit directors should be held to even “higher standards of care and loyalty” because their organizations “comprise a public good.”220 moreover, the role of a nonprofit director arguably is more challenging. unlike the straightforward goal of profitmaximization in a for-profit, a nonprofit’s goals are generally more complex, multi-faceted, and frequently ill defined.221 the role of nonprofit directors is said to be more “nuanced,” requiring the reconciliation of both business objectives and mission—what some have termed a “balance of mission and margin.”222 that many believe this balance often has been missed is shown by the actions of senator grassley and the new community benefit requirements recently promulgated under the aca.223 iv. the affordable care act: changing the focus? it goes without saying that the aca224 was expressly designed to address many perceived shortcomings in the u.s. health care delivery system. generally speaking, the current system has been viewed as competitive (in an unhelpful way),225 fragmented, and driven by 219 see id. at 356. 220 see id. at 397. 221 see greaney & boozang, supra note 54, at 36. 222 see id. at 36-39. 223 see infra section iv(a)(3)(a). 224 “on march 23, 2010, congress enacted the patient protection and affordable care act (ppaca). . . . congress, recognizing there were a number of provisions in the ppaca that needed further refinement, enacted the health care and education reconciliation act of 2010 (hcera) on march 30, 2010. together, ppaca and hcera are referred to as the affordable care act. on june 28, 2012, the supreme court upheld the ppaca, holding that it is constitutional.” medicare certified accountable care organizations, in 2013 health law and compliance update 1 (john steiner ed., 2013). 225 “unhelpful” in the sense that physicians have increasingly come to compete with hospitals to provide such things as ambulatory surgery centers and various advanced technologies and diagnostics–resulting in 146 indiana health law review vol. 12:1 counterproductive financial incentives.226 these features have resulted in growing concerns over poor quality, spiraling costs, and rising barriers to access—all issues that have been thoroughly addressed and documented elsewhere. there is seemingly broad consensus, professional and academic if not political, that the solution lies with transition to an “integrated and coordinated care model” that is predicated upon “systems-based care management” that will consistently produce efficient, high quality services through greater collaboration among system participants.227 while this new focus is readily described, it is somewhat more complicated to bring about, constituting what some have called a “battle for the soul of american medicine,”228 as well as the “‘biggest transformation of government since world war ii.’”229 moreover, it involves far more than simply modifying the “broad, complex, and indirect regulatory approaches that inevitably have unintended consequences”230—it involves quite literally reforming the entire health care system.231 although such reform encompasses innumerable individual changes, at least three “cornerstone” themes are usually acknowledged: accountability, efficiency, and quality.232 to “over-utilization, higher complication rates, and escalating charges.” see robin locke nagele, hospital-physician relationships after national health reform: moving from competition to collaboration, 82 pa. b. ass’n. q. 1, 2 (2011). 226 see generally id. at 1-3. 227 see id. at 1-2, 11. 228 see id. at 2. 229 see gary s. davis & michael l. silhol, healthcare reform: the law and its implications, 20101206 ahla seminar papers 24 (2010) at p. 98 (citing jackie calmes, after health care passage, obama pushes to get it rolling, n.y. times, apr. 18, 2010, at a16 (quoting david cutler, harvard economist and president obama's chief campaign adviser of health policy.). 230 for example, fraud and abuse laws and regulations that become significant obstacles to the adoption of “potentially cost-reducing or quality-enhancing innovation.” see kristin madison, rethinking fraud regulation by rethinking the health care system, 32 hamline j. pub. l. & pol’y 411, 415-16 (2011). 231 see id. at 416-17, 427. 232 see anne p. sharamitaro, healthcare reform: impact on hospitals, 4 health capital topics, 1, 1 (2011) archived at 2015 healthcare corporate structure and the aca 147 this can be added the additional theme of value, as discussed further in section iv(a)(4) infra. while it is difficult to summarize legislation that runs to approximately 2,400 pages,233 it is useful to look at the act’s overall framework. at the outset, it should be noted that the aca amends several other existing statutes: the public health service act (phsa), the fair labor standards act (flsa), the social security act (ssa), the internal revenue code (irc), the employee retirement income security act of 1974 (erisa), and the deficit reduction act of 2005 (dra). 234 the aca itself is divided into ten separate titles:235 title i quality, affordable health care for all americans; title ii role of public programs; title iii improving the quality and efficiency of health care; title ivprevention of chronic disease and improving public health; title v health care workforce; title vi transparency and program integrity; title vii improving access to innovative medical therapies; title viii class act;236 title ix revenue provisions; and, title x strengthening quality, affordable health care for all americans. collectively, these titles affect almost every part of the health care system. 237 for the purposes of this article, only those sections most relevant to the issues under discussion are listed and briefly described below: title ix, § 9007 the act adds a new section 501(r) to the irc, including new community benefit requirements that nonprofit hospitals must meet to maintain their tax-exempt status http://perma.cc/tu2p-kkn7. 233 kurt manwaring, how many pages are in the affordable care act? kurt’s perspective (aug. 5, 2011, 10:49 pm), http://kurtsperspective.blogspot.com/2011/08/how-many-pages-are-inaffordable-care.html. 234 davis & silhol, supra note 229, at 99. 235 id. at 99-100. 236 id. at 99 n.7 (“title viii is a voluntary, national long-term care insurance program.”). 237 id. at 99. 148 indiana health law review vol. 12:1 under irc section 501(c)(3).238 (see section iv(a)(3)(a) infra.) title vi, §§ 6001, 6002, 6401, 6402 & 6409; title x, § 10606 several new anti-fraud and payment program initiatives are added by the act, including (among other things) new transparency requirements governing the relationships between and among drug and device companies, physicians, and teaching hospitals.239 significantly, § 6001 has eliminated the “whole hospital exception” of the stark law.240 title i, §§ 1001, 1101, 1201, 1251, 1301 & 1311; title x, §§ 10101 & 10103 hcera,241 §§ 1102 & 1103 these sections collectively reform many aspects of the health insurance market, including: “new requirements related to underwriting, scope of benefits, and rating;” establishing medical loss ratio (mlr) requirements; expansion of coverage to “dependents up to age 26”; “elimination of pre-existing condition exclusions”; and the cost-sharing requirements by health plans for emergency services. of greatest significance, these sections establish the “state-based insurance exchanges” and mandate “guaranteed issue and guaranteed renewal” of coverage in the entire private insurance market.242 title iii, §§ 3001, 3008 & 3025 a major priority of the act is to motivate hospitals to improve quality through medicare payment adjustments in response to various performance measures. to this end, the act establishes new programs covering such things as value-based purchasing, payment adjustments for hospital 238 see id. at 80-81. 239 see id. at 84. 240 see nagele, supra note 226, at 9. 241 the health care and education reconciliation act of 2010. 242 davis & silhol, supra note 229, at 86. 2015 healthcare corporate structure and the aca 149 acquired conditions, and hospital readmissions reduction.243 title i, § 1311; title ii, §§ 2702, 2717 & 2718; title iii, §§ 3001, 3002, 3011, 3012, 3021, 3023, 3501 & 3502; title vi, § 6301 all of these sections deal, in one way or another, with the act’s objective of motivating development of the health information technology (hit) infrastructure necessary to support the coordination of care, quality measurement and reporting, and new payment models. such infrastructure is also seen as essential to the continued progress of biomedical research and the eventual implementation of personalized medicine.244 title ii, §§ 2704, 2705 & 2706; title iii, §§ 3001, 3021, 3022, 3023, 3025, 3027 & 3502; title x, §§ 10307 & 10333 under the act, significant cuts will be made in medicare and medicaid (estimated to be $330 billion). various provisions under the above sections are designed to “shift the payment system from traditional fee-for-service (ffs) to budgeted (e.g., shared savings, bundled payments based on episodes of care, capitation) or value-based (e.g., pay-forperformance) payment models.” a key initiative under this effort is the development of accountable care organizations (acos). (see section iv(a)(4)(a) infra.)245 a. how will new aca imperatives affect the traditional organizational forms? obviously, the above-described imperatives will significantly impact the way all hospitals operate in the future. in some cases, it is clear that the effect will differ depending on the hospital’s organizational form. the most obvious example (discussed in section iv(a)(3)(a) infra) is the new community benefit requirements that apply only to 243 id. at 87-88. 244 id. at 90. 245 id. at 91. 150 indiana health law review vol. 12:1 nonprofits. it is less obvious, or currently speculative, whether other imperatives will differentially impact nonprofit and for-profit organizations. what is clear is that the operating environment is changing, with new demands challenging organizations’ historical attitudes about the sufficiency of their size and market position.246 as davis and silhol have noted: [m]any have recognized that growth and scale are critical to meeting the new cost, quality and reporting obligations that will be imposed upon them. in light of this, an increasingly important aspect of an institution's strategy will be the active consideration of mergers, acquisitions, member substitutions, joint ventures opand clinical affiliations with other hospitals, health systems and academic medical centers.247 the sections that follow attempt to discern how organizational form may affect, and be affected by, these challenges. 1. industry consolidation as discussed in section ii(b) supra, the hospital industry has gone through prior periods of consolidation, largely precipitated by the advent of third-party and governmental payors and the development of both nonprofit and for-profit systems. many experts foresee the aca resulting in yet another period of consolidation.248 in addition to significantly expanding the number of insured patients, the aca will bring new reimbursement models designed to 246 id. at 96. 247 id. (emphasis added). 248 see samuel r. maizel and mary d. lane, the sale of nonprofit hospitals through bankruptcy: what bapcpa wrought, 30 am. bankr. inst. j. 12, 73 (2011) (citing the impact of healthcare reform on hospital consolidation, backer's hospital review (sept. 16, 2010) (“[h]ealthcare reform will affect hospital consolidation in three ways: by decreasing revenues, increasing costs and rewarding integration.”)). 2015 healthcare corporate structure and the aca 151 incentivize the provision of more integrated and coordinated care.249 pressures to consolidate will be particularly acute for financially distressed, unaffiliated hospitals and small systems—most of which are nonprofits.250 for many of these organizations, merger with a larger nonprofit system or sale to a for-profit chain may be the only option to improve their operating margins, ensure continued access to credit and capital, acquire and implement information technology, and otherwise develop necessary efficiencies of scale and coordination—all foreseeably required to meet the new imperatives of the aca.251 a. the demise of physician-owned, specialty hospitals for-profit, physician-owned, specialty hospitals are one type of facility whose fate under the aca is not uncertain. as previously discussed,252 by the year 2010 such facilities were coming under intense criticism for such perceived failings as: having disproportionately higher costs (largely due to compensation mechanisms that promoted overutilization by practicing physician-owners with financial conflicts of interest); failing to care for uninsured, severely ill, or otherwise unprofitable patients; and, jeopardizing patient safety by operating without on-site emergency departments.253 with § 6001 of the aca having eliminated the “whole hospital exception” of the stark law and having placed several new restrictions on currently operating facilities,254 the era of the physician-owned, specialty hospital appears to be over. it remains to be seen whether existing facilities will continue to operate with the new restrictions, or will simply liquidate or sell to other traditional institutional providers. 249 davis & silhol, supra note 229, at 111. 250 see zall & kinsella, supra note 61, at 11. 251 see id. 252 see supra section ii(b)(2). 253 perry, supra note 67, at 1. 254 id. at 40-43. 152 indiana health law review vol. 12:1 2. the growing importance of capital as stewart and smith note: the delivery of 21st century health care services in the united states is an increasingly capital intensive enterprise . . . . the need to replace and renovate aging facilities and a growing demand for new diagnostic and treatment equipment driven by a rapidly advancing medical technology increases demand for capital financing. furthermore, the escalating need for large investments in information technology required to implement fully integrated electronic health records (ehrs) and computerized provider order entry systems (cpoes) also create a demand for significant capital financing.255 since the time that charitable, nonprofit hospitals first became commercial, fee-charging businesses comparable to their for-profit counterparts, it has been debatable which corporate form has better access to necessary capital. a simple analysis begins with consideration of the four commonly used sources of available capital: taxable bonds, tax-exempt bonds, charitable contributions, and stock.256 some believe that charitable nonprofits have the advantage by virtue of their access to tax-exempt bonds and tax-deductible charitable contributions—both of which contribute to a lower “weighted average cost of capital” (wacc).257 moreover, nonprofits have benefited in recent 255 louis j. stewart & pamela c. smith, an examination of contemporary financing practices and the global financial crisis on nonprofit multi-hospital health systems, 37 j. health care fin. 1, 124 (2011). 256 schirra, supra note 30, at 252. 257 wacc is the weighted average of the component costs of capital. it is less for charitable nonprofits because (1) the interest payable on tax-exempt bonds is less (than on taxable bonds) due to the interest received by the bondholder being non-taxable, and (2) donations to taxexempt nonprofits are tax-deductible by the donor. see generally id. at 2015 healthcare corporate structure and the aca 153 years from the previously described practice of tax arbitrage,258 which enables them to retain more of their net earnings for application to capital needs. in addition, nonprofits are more likely to receive governmental grants and private foundation funding.259 the downside of nonprofits’ position, however, is their necessary reliance on tax-exemption for these advantages. clearly, a loss of taxexemption would be disastrous for most nonprofits. others believe that the cost of capital is not as important as access to capital. in this regard, for-profit hospitals have many more ways to raise capital than do nonprofits.260 foremost among them, of course, is the issuance of stock to investors looking for a return on investment from share appreciation (i.e., capital gains) or dividends.261 more broadly speaking, however, for-profits are free to engage in all manner of capital-raising devices foreclosed to nonprofits by the “private inurement doctrine”262—e.g., private bond markets, mortgages, capital leases, secured loans, real estate investment trusts, etc.263 in addition, one can reasonably expect a greater willingness by venture capitalists to work with for-profits, since they do not have to contend with the private inurement constraint. 3. a diminishing need for charity care “if, as a result of health care reform, everyone has health insurance, presumably hospitals should see a steep decline in, or the elimination of, uncompensated care . . . . given 251-253. 258 see supra section iii(b). 259 schirra, supra note 30, at 261. 260 id. at 262. 261 id. 262 “private inurement occurs whenever persons having a personal and private interest in a nonprofit hospital receive benefits disproportionate to their contributions to the entity.” id. at 245 (citing treas reg. § 1.501(a)-1(c) (west 2011)). 263 robert j. cimasi & anne p. sharamitaro, value metrics and capital formation for accountable care organizations, 15 valst 6, 13 (2012). 154 indiana health law review vol. 12:1 this trend, does it make sense to retain taxexemption for hospitals?”264 following the implementation of medicare and medicaid, there was a similar expectation that hospitals would be confronted with less need to provide uncompensated care.265 not surprisingly, arguments very similar to senator grassley’s were likewise raised when the irs subsequently proposed to “transition from a ‘charity care’ standard to a ‘community benefit’ standard under section 501(c)(3).”266 under the aca, it is expected that the need for charity care will be further reduced through two primary mechanisms: (1) implementation of the individual mandate to buy insurance (with available federal subsidies where appropriate) and development of the “health insurance exchanges” (hixs) to facilitate people doing so; and, (2) state expansion of medicaid eligibility to now cover “adults with incomes up to 138% of the federal poverty level (“fpl”).”267 although initially required as part of the aca, state participation in the medicaid expansion was made optional for the states by the u.s. supreme court decision in national federation of independent business v. sebelius.268 according to dorn et al., even if no state participates in medicaid expansion, the aca will still result in a 28% reduction in the number of uninsured by 2022 by means of the act’s “[n]ew subsidies in hixs, individual coverage 264 katie stewart & darren azman, section 501(r) and nonprofit hospital joint ventures, 22 taxation of exempts 9 (citing roundtable discussion on comprehensive healthcare reform: hearing before the s. comm. on fin., 111th cong. 118 (2009) (statement of sen. charles e. grassley)). 265 id. 266 id. (citing staff of the s. comm. on fin., 91st cong., medicare and medicaid: problems, issues, and alternatives 56 (comm. print 1970)). 267 see generally stan dorn, et al., the financial benefit to hospitals from state expansion of medicaid, timely analysis of immediate health policy issues (2013), available at http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2013/rwjf405 040. 268 132 s. ct. 2566 (2012). 2015 healthcare corporate structure and the aca 155 requirements, incentives for employer-sponsored coverage, and streamlined enrollment methods.”269 if all states participate, then the number of uninsured will be reduced by 48%.270 the intuitive fact that the uninsured generate more uncompensated care than the insured has been demonstrated by hadley et al.271 this has been confirmed by the experience in massachusetts, where 2006 health reforms that reduced the number of uninsured resulted in a near 40% reduction in uncompensated care costs in the first year.272 however, as schirra notes, “there will still be approximately fourteen million uninsured americans, not including illegal aliens, after full implementation” of the aca.273 the question becomes whether nonprofits’ current level of tax-exemption can continue to be justified after such a reduction in the need for charity care? a. additional regulatory burdens on nonprofits the new community benefit requirements set forth in aca § 9007 resulted from the many recent criticisms of nonprofits previously discussed, as well as the expected reduction in the need for uncompensated care under the act.274 in fact, the provisions of § 9007 (with one exception) closely follow the may 2009 senate finance committee proposal275 submitted by senators grassley and baucus.276 269 dorn et al., supra note 267, at 4. 270 id. 271 id. (citing hadley j. et. al., covering the uninsured in 2008: current costs, sources of payment, and incremental costs, health affairs, 27(5): w399-w415, 2008). 272 see id. (citing 2009 annual report health safety net, boston: massachusetts division of health care finance and policy; access to health care in massachusetts: results .from the 2008 and 2009 massachusetts health insurance survey, boston: massachusetts division of health care finance and policy, 2009). 273 see schirra, supra note 30, at 274. 274 see michael n. fine & christopher m. jedrey, “show me the money”: maintaining hospital tax-exempt status, 22 taxation of exempts 3 (2010). 275 see supra section iii(b)(1). 276 fine, supra note 274, at 5. (the biggest difference is that the act 156 indiana health law review vol. 12:1 under the aca’s corresponding new § 501(r) of the internal revenue code,277 obtaining or retaining taxexempt status now requires that hospitals: 1. establish written policies regarding patient eligibility for financial assistance and the provision of emergency care; 2. limit the amount charged to patients eligible for financial assistance for emergency or medically necessary care to the amount generally billed for insured patients; 3. refrain from pursuing “extraordinary collection actions” without first inquiring whether a patient is eligible for financial assistance; and, 4. at least once every three years, conduct a “community health needs assessment” and adopt an ‘implementation strategy’ to respond to the needs identified by the assessment.278 doesn’t require a minimum level of charity care. id. at 6). 277 see mary crossley, tax-exempt hospitals, community health needs and addressing disparities, 55 how. l.j. 687, 692 (2012) (citing ppaca, pub. l. no. 111-148, § 9007(a), 124 stat. 119, 855-57 (2010), amended by ppaca, pub. l. no. 111-148, § 10903(a), 124 stat. 119, 1016 (codified at 26 u.s.c. § 501(r) (and re-designating existing § 501(r) as § 501(s))). 278 id at 693. crossley provides a good, concise summary of the specific requirements of the chna: “[a] hospital must conduct a chna . . . taking into account ‘input from persons who represent the broad interests of the community served by the hospital facility, including those with special knowledge of or expertise in public health.’ once the chna has been completed, the hospital must make the assessment ‘widely available to the public.’ then the hospital must adopt an ‘implementation strategy to meet the community health needs identified through such assessment,’ and, finally, it must report to the irs ‘how the organization is addressing the needs identified’ and ‘a description of any such needs that are not being addressed together with the reasons why such needs are not being addressed.’ by establishing this multistep process, the aca seeks to ensure that tax-exempt hospitals are in fact providing community benefits by requiring them first to assess what specific health needs their communities have, then to take steps to 2015 healthcare corporate structure and the aca 157 nonetheless, fine and jedrey note that tax-exempt hospitals are still obliged to “seek payment for services” from non-paying patients or risk “violating certain medicare and medicaid billing requirements.”279 in any event, the breadth and complexity of these new regulatory requirements will clearly add to the burden and compliance cost for tax-exempt, nonprofit hospitals—a burden and cost not imposed on their for-profit counterparts. 4. cornerstone themes: quality, value, efficiency, and accountability as previously noted, while the aca’s systemic reform of health care delivery involves innumerable individual changes, a focus on quality, value, efficiency, and accountability are central to addressing the current system’s acknowledged problems with poor quality, spiraling costs, and rising barriers to access. to this end, more than anything else, federal health care payments will be transitioned from “payment for volume” to “payment for quality.”280 much of this effort will be accomplished through a variety of new programs found in title iii of the act: ▪ the hospital value-based purchasing program (a mandatory program),281 ▪ the payment adjustment for conditions acquired in hospitals (a mandatory program),282 meet those needs, and, finally, to report what they are doing to the irs. a tax-exempt hospital that fails to comply with these requirements will be subject to a $50,000 excise tax.” id. at 693. 279 fine and jedrey, supra note 274, at 6. 280 see christi j. braun & michelle d. johnson, provider alignment for quality and payment: new takes on old ideas (2010). 281 the affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010) (to be codified as amended in scattered sections of 21, 25, 26, 29, and 42 u.s.c.). see also title iii, part 1: linking payment to quality outcomes under the medicare program, § 3001, available at http://www.gpo.gov/fdsys/pkg/plaw-111publ148/pdf/plaw111publ148.pdf. 282 id. at § 3008. 158 indiana health law review vol. 12:1 ▪ the physician quality reporting initiative (a mandatory program),283 ▪ the value-based physician payment modifier (a mandatory program),284 ▪ the hospital readmissions reduction program (a mandatory program),285 ▪ the medicare shared savings program (a voluntary program),286 and ▪ the payment bundling pilot program (a demonstration program).287 while a detailed description of each of these programs is beyond the scope of this article, the focus of most of them is self-evident from their titles. one exception is the hospital value-based purchasing program, wherein participating hospitals will receive incentive payments for meeting or exceeding certain cms-designated performance benchmarks, including metrics of quality, efficiency and patient satisfaction.288 these metrics will initially address treatment and outcomes for such clinical conditions as pneumonia, heart failure, and hospital-acquired infections, with other conditions to be added later.289 another exception that merits further discussion is the development of accountable care organizations (acos) under the medicare shared savings program (mssp), since this program is expected to give rise to new organizational structures.290 a. acos: alignment and integration of multiple stakeholders section 3022 of the affordable care act amends title xviii of the social security act 283 id. at § 3002. 284 id. at § 3007. 285 id. at § 3025. 286 id. at § 3022. 287 id. at § 3023. 288 see sharamitaro, supra note 232. 289 see id. 290 see id. 2015 healthcare corporate structure and the aca 159 (ssa) (42 u.s.c. 1395 et seq.) . . . to establish a medicare shared savings program that promotes accountability for care of medicare beneficiaries, improves the coordination of medicare fee-for-service items and services, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery. under [new] § 1899(b)(1) of the ssa, groups of health care service providers and suppliers that have established a mechanism for shared governance and that meet criteria specified by hhs are eligible to participate as acos under the program.291 acos are among the key strategies under the aca to improve quality and lower cost by promoting organizational structures that will coordinate and integrate the care provided by different service providers in various settings.292 participating providers293 will assume overall responsibility for controlling the quality and cost of care for a defined population of patients.294 the providers will then partner with payors to create incentives for the delivery of care of higher quality and 291 irs notice 2011-20, background on acos and the mssp, at 1, available at: http://www.irs.gov/pub/irs-drop/n-11-20.pdf. 292 see kristin l. reiter & paula h. song, hospital capital budgeting in an era of transformation, 39 j. health care fin. 14 (2013). 293 “[t]he following groups of providers of services and suppliers which have established a mechanism for shared governance are eligible to participate as acos under the program under this section: (a) aco professionals in group practice arrangements. (b) networks of individual practices of aco professionals. (c) partnerships or joint venture arrangements between hospitals and aco professionals. (d) hospitals employing aco professionals. (e) such other groups of providers of services and suppliers as the secretary determines appropriate.” patient protection and affordable care act, pub. l. no. 111148, 124 stat. 119 (2010) (codified in scattered sections of 42 u.s.c.), title iii, part 3 – encouraging development of new patient care models, § 3022. 294 reiter & song, supra note 292, at 14. 160 indiana health law review vol. 12:1 lower cost than customary under fee-for-service, using flexible forms of reimbursement that may include “shared savings programs,” penalties, and various forms of capitation.295 one of the most interesting features of acos is the enhanced involvement of multiple “stakeholders,” including both individual professionals (e.g., physicians) and institutions (e.g., hospitals, group practices, payors, etc.). by design, the aca has not specified any particular legal or organizational form through which these multiple stakeholders are to accomplish the requisite “shared governance” of the aco.296 at present, the aco itself can be a nonprofit corporation, a for-profit 295 id. at 14-15. 296 “section 1899(b)(2) of the ssa establishes the following requirements for an aco to participate in the program: (1) the aco shall be willing to become accountable for the quality, cost, and overall care of the medicare fee-for-service beneficiaries assigned to it. (2) the aco shall enter into an agreement with the hhs secretary to participate in the program for not less than a 3-year period (the mssp agreement period). (3) the aco shall have a formal legal structure that would allow the organization to receive and distribute payments for shared savings under § 1899(d)(2) to participating providers of services and suppliers. (4) the aco shall include primary care aco professionals that are sufficient for the number of medicare fee-for-service beneficiaries assigned to the aco under § 1899(c). at a minimum, the aco shall have at least 5,000 such beneficiaries assigned to it under § 1899(c) in order to be eligible to participate in the mssp. (5) the aco shall provide the hhs secretary with such information regarding aco professionals participating in the aco as the secretary determines necessary to support the assignment of medicare fee-for-service beneficiaries to an aco, the implementation of quality and the other reporting requirements under§ 1899(b)(3), and the determination of payments for shared savings under § 1899(d)(2). (6) the aco shall have in place a leadership and management structure that includes clinical and administrative systems. (7) the aco shall define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care, such as through the use of telehealth, remote patient monitoring, and other such enabling technologies. (8) the aco shall demonstrate to the hhs secretary that it meets patient-centeredness criteria specified by the secretary, such as the use of patient and caregiver assessments or the use of individualized care plans.” irs notice 2011-20, background on acos and the mssp, at 2. 2015 healthcare corporate structure and the aca 161 corporation, some other type of legal business entity (e.g., limited liability company, partnership, etc.), or even some type of contractual joint venture—so long as all other statutory (and eventually regulatory) requirements are met. needless to say, however, if tax-exempt nonprofits participate in an aco, they must be concerned (at least for now) with the possibility that their involvement will run afoul of the private inurement doctrine. in this regard, johnson and moroney have noted: in notice 2011-20 (03/31/11), the irs announced that, under certain conditions,297 it generally would not consider a tax-exempt organization's participation in the mssp through an aco to result in inurement or substantial private benefit. . . . [t]he irs stated its expectation that mssp payments would be derived from activities that are substantially related to the performance of the charitable purpose of lessening the burdens of government within the meaning of treas. reg. 297 “the irs said that due to the centers for medicare and medical services (cms) oversight in the compliance and eligibility for participation of acos in the mssp program [a joint venture aco] [sic] would not ‘generally’ result in prohibited inurement or private benefit if the following guidelines were met: • the term of the tax-exempt organization's participation (including its share of mssp payments) are set forth in advance in writing and negotiated at arm's length. • cms has accepted the aco into the mssp. • the tax-exempt entity's share of economic benefits from the aco is proportional to the benefits or contributions provided to the aco by the tax-exempt entity. if the tax-exempt entity receives an ownership interest in the aco, the amount of its capital contributions must be proportional and equal in value to its ownership interest and distributions must be made in proportion to ownership interests. • the tax-exempt entity' s share of the aco's losses doesn't exceed its share of the economic benefits. • all transactions among the tax-exempt entity and the aco (or its participants) must be fair market value.” milton cerny & barton c. walker, nonprofit healthcare: what does the future hold?, (mcguire woods llp), 2011, at 6., archived at http://perma.cc/89bu-rlwx. 162 indiana health law review vol. 12:1 § 1.501(c)(3)-1(d)(2). . . . ‘congress established the mssp to be conducted through acos in order to promote quality improvements and cost savings, thereby lessening the government's burden associated with providing medicare benefits.’ . . . the irs cautioned, however, that not every activity that promotes health is considered to be a charitable purpose. accordingly, aco arrangements entered into outside the mssp (e.g., with commercial payors) are unlikely to lessen the burdens of government and conceivably may not further any other charitable purposes.298 the last sentence above makes an important point worth emphasizing: while the aca has in a sense “created” the aco under the mssp, the law does not require all acos to participate in the mssp. that is to say, the aca does not prohibit the development of “private” acos, which are free to organize and operate independent of the medicare program. in theory, at least for now, such acos could operate entirely as for-profit enterprises relying solely on reimbursement from non-governmental, third-party payors (which appears to be increasingly happening, with several major insurers partnering with acos to serve purely “commercial” enrollees in markets throughout the u.s.). regardless, all prospective acos at present are confronted with the uncertainty of how the various fraudand-abuse and antitrust regulators299 will react to their efforts to achieve the financial and clinical integration necessary for success.300 one of the ironies of health care reform is the direct conflict between the aca’s focus on 298 tricia m. johnson & linda s. moroney, tax issues for healthcare organizations, 20111002 ahla seminar papers 63, at 29 (2011) (emphasis added). 299 for example, the center for medicare and medicaid services (cms), the office of inspector general (oig), the department of justice (doj) and the federal trade commission (ftc). see nagele, supra note 226, at 2. 300 see nagele, supra note 226, at 1-2. 2015 healthcare corporate structure and the aca 163 integration and coordination of multiple system participants, and the historic prosecution of such activities under the anti-trust, stark and anti-kickback laws. finally, reiter and song identify three particularly significant challenges facing hospitals engaged in aco development: ▪ “managing the priorities of a broad range of stakeholders; ▪ thriving in a payment environment driven by value rather than volume; and ▪ finding sufficient capital to allocate to it.”301 b. is the aca’s focus compatible with commercialized medicine? as perry has noted, the “forces of commercialization” in health care have “coalesced to create a powerful $2.5 trillion industry that, in 2009, constituted greater than 17% of the nation’s economy.”302 these forces of course include more than just doctors and hospitals—they include health insurers, health care manufacturers and suppliers, pharmaceutical companies, all manner of other individual health care professionals who serve patients directly, and other non-health care professionals and industries providing support to the health care sector in general. many if not most of these other participants are for-profit companies, which, in their efforts to maximize profits, also help the economy by providing jobs and exports.303 it is this entire “web” of participants (as well as advances in medical science and technology) that has commercialized health care delivery in the united states. if the aca is to succeed, it will have to do so in this context—a now unalterable fact of modern health care economics. the question therefore is: how does one provide the public good of, or right to, high-quality, high-value health 301 reiter & song, supra note 292, at 20. 302 perry, supra note 2, at 54. 303 see kinney, supra note 82, at 419. 164 indiana health law review vol. 12:1 care in a competitive, free-market economy? the aca’s answer (to the dismay of many) was not through a government-operated, single-payor system. had the aca taken that approach—paying for health care services out of general revenues as a matter of right for all americans—the conflicting objectives and divergent characteristics of nonprofit and for-profit hospitals would likely diminish if not disappear entirely over time: that is, tax-exempt status would become irrelevant since there would be no need for charity care; the problem of nonprofits being too aggressive in mimicking for-profits’ business practices would be a nonissue since all hospitals would ostensibly operate under the same rules to accomplish the same ends; and, “unhelpful” inter-institutional competition would probably lessen since there would be little opportunity to obtain a differential advantage, at least financially. instead, however, the aca took an approach based upon the “managed competition” model of the 1990s as developed by alain enthoven of stanford university.304 that model reflects “a blending of competitive and regulatory strategies that must co-exist in the healthcare industry and which aim to achieve maximum value for both consumers and providers.”305 the model represents a compromise “springing from a belief that healthcare is both a right and an obligation . . . i.e., that people have a right to access and an obligation to pay for their portion.”306 the aca’s framework also follows an approach to health care reform that was developed in massachusetts and enacted there in 2006.307 the framework builds upon what kirsch characterizes as “the four pillars of the current health care coverage system: employer provided coverage, medicaid, medicare, and individually purchased insurance.”308 like the massachusetts legislation, the aca 304 see cimasi and sharamitaro, supra note 263, at 7. 305 id. at 8 (citing enthoven, the history and principals of managed competition, 12 health affairs supp. 24 (1993)). 306 id. (citing morrison, the new american compromise, 61 h&hn 32 (september 2008)) (emphasis in original). 307 see kirsch, supra note 3, at 1741. 308 id. 2015 healthcare corporate structure and the aca 165 incorporates a compromise innovation first promoted by the conservative heritage foundation—an individual mandate to obtain coverage that is provided through a “marketplace” of private health insurance (i.e., the “exchanges”).309 this is clearly a “commercialized” approach, notwithstanding a degree of government involvement. as grogan aptly summarizes it: under the aca . . . the government (state and federal) will (1) determine the basic benefit package that all health insurance plans must provide to participate in the insurance exchange; (2) more heavily regulate private insurance companies, including barring actuarial risk rating when setting premiums; and (3) provide public subsidies for some families to purchase private health insurance on the exchange. in light of these responsibilities, it is clearly farcical to label the new health insurance arrangements predominantly private. but the government is also so completely dependent on private actors—from hospitals, providers, and pharmaceutical companies to private insurance companies—to get the whole thing to work, that one can hardly call the aca a government takeover. it is a two-way dependency.310 v. a new organizational paradigm under the aca approach, delivery system participants remain disparate—some will pursue profit-maximization, others will pursue the public good. yet, as previously noted, the fundamental purpose of the aca is to transform the current fragmented delivery system into an integrated and coordinated care model that consistently produces improved 309 see id. 310 colleen m. grogan, you call it public, i call it private, let’s call the whole thing off?, 36 j. health pol. pol’y & l. 401, 403 (2011) (emphasis added). 166 indiana health law review vol. 12:1 quality, greater accessibility, and lower cost. acos are central to this effort by virtue of their specific intent to effect greater collaboration between and among these disparate system participants. however, such collaboration will necessarily remain hindered by the conflicting organizational objectives inherent in the nonprofit versus for-profit dichotomy. what may be needed now is a new organizational paradigm. a. the need for mission primacy some have argued that the concept of “mission primacy”—a “doctrinal recognition” that a corporation’s “articulated mission” should be its legally-enforceable primary objective (as is profit-maximization for a for-profit corporation)311—should be more strictly applied to taxexempt, nonprofit health care corporations in order to better ensure director fidelity to the organizations’ charitable missions.312 this approach appears warranted in view of the significant evidence that threatened loss of taxexemption is, by itself, insufficient to ensure that nonprofits provide an appropriate and expected level of public benefit.313 as greaney and boozang explain: as a general guiding principle, we suggest that “mission primacy” should be recognized as a central objective of the nonprofit enterprise . . . . this focus would incorporate missioncentered values into interpretations of the traditional fiduciary duties of care and loyalty. at the same time, like the model of “director primacy” advanced for proprietary corporations, it would preserve managerial discretion to balance the various constituents of the nonprofit firm including donors, consumers, and the community. consequently, this standard would accommodate the 311 see discussion, supra section iii(d)(1). 312 see generally, greaney and boozang, supra note 54, at 5. 313 see id. at 6. 2015 healthcare corporate structure and the aca 167 relational imperatives of the modern business environment in health care. . . . finally, mission primacy accounts for the particular circumstances of nonprofit governance because it preserves the central values of trust and volunteerism that are needed to reinforce legal duties.314 the recognition that mission objectives other than pursuit of profit are sufficiently important in health care to justify giving them more formalized legal status finds support in robert g. evans’ concept of a “‘not-only-for-profit’ sector”—a designation referring to “firms ‘in which a legal claimant to profits is well-defined, but profits represent only one among several competing objectives of the firm’s ownership and management.’”315 this designation seems particularly apropos to acos, the acknowledged purpose of which is to improve the value, quality, and efficiency of health care services, as well as accountability for their delivery. pursuit of “profit”—in the sense of residual revenue over expenses necessary to meet ongoing capital needs for replacement and growth—would necessarily remain, but as a secondary rather than sole or even primary objective. because accomplishing an aco’s purpose requires a significant degree of integration of, and collaboration among, different entities (nonprofit and for-profit alike), a new mission-centered form of health care organization specifically designed to serve the diverse objectives of multiple stakeholders makes sense, since the directors of such a new organization would have an explicit, legallyenforceable duty to take all mission considerations into full account in their business decision-making.316 314 id. at 83-84 (emphasis added). 315 see marmor, et al., supra note 12, at 319 (quoting robert evans, strained mercy: the economics of canadian health care at 127 (1984)) (emphasis added). 316 see greaney & boozang, supra note 54, at 84. 168 indiana health law review vol. 12:1 1. constituency statutes similar in purpose to this idea are what have variously been called “constituency,” “stakeholder,” or “nonshareholder” statutes—found (as of 2002) in 33 states.317 these statutes permit, but do not require, directors to make decisions based on considerations other than strictly shareholder interests. 318 the statutes then shield the directors from at least some personal liability for doing so.319 however, while such statutes may be a way to encourage corporations to balance the interests of multiple stakeholders, they have been largely discredited (at least in their current forms) for being discretionary and lacking any clear-cut enforcement mechanisms.320 moreover, they have been used mostly in connection with takeover defenses, serving merely to entrench the interests of existing management rather than to defend the interests of other stakeholders.321 this has prompted jonathan springer, acknowledged to be the preeminent scholar on constituency statutes, to suggest: “[i]f there is any fundamental change in corporate law that will address constituency interests, it will be only as the result of a direct engagement of the legal and economic underpinnings of corporate law.”322 that is, the norm of shareholder wealth maximization must be challenged outright.323 317 briana cummings, benefit corporations: how to enforce a mandate to promote the public interest, 112 colum. l. rev. 578, 587588 (2012) (citing lisa m. fairfax, doing well while doing good: reassessing the scope of directors' fiduciary obligations in for-profit corporations with non-shareholder beneficiaries, 59 wash. & lee l. rev. 409, 460 n.285 (2002) (describing longstanding debate between shareholder and stakeholder theories)). 318 see clarke, supra note 6, at 306-307. 319 id. at 307. 320 id. 321 kanig, supra note 8, at 887. 322 id. (quoting jonathan d. springer, corporate constituency statutes: hollow hopes and false fears, 1999 ann. surv. am. l. 85 (1999)). 323 id. 2015 healthcare corporate structure and the aca 169 b. hybrid legal structures in recent years, a variety of new legal forms have been proposed to do just that. under the general rubric of “hybrid legal structures,” these new forms include “sociallyresponsible business corporations,” “social enterprise” or “social entrepreneurship” organizations, and “not-for-loss corporations.”324 most of these proposals have come from the “social entrepreneurship movement” of recent years that has promoted development of sustainable organizations designed to provide specific solutions to social problems.325 the organizations can take the form of either a businessoriented nonprofit or a mission-oriented for-profit.326 according to clarke, these entities “tread[] against the very essence of the for-profit motive”327 by defining stakeholder benefit as the primary purpose of the organization, in contravention of which the organization may not act. 328 in many ways, this brings the argument full circle and returns to the position of edwin merrick dodd, who advocated for the “stakeholder theory of corporate governance.”329 it is ironic that dodd argued during the “great depression” that “the corporation is a ‘social institution’ . . . the byproduct of a bargain between the state and private actors to construct a vehicle for wealth creation that carries concurrent obligations to parties beyond its direct owners;”330 whereas today, on the heels of the “great recession” and within the context of the ongoing debate over the aca, grogan argues that “the government is . . . so completely dependent on private actors—from hospitals, providers, and pharmaceutical companies to private insurance companies—to get the whole thing to work, that . 324 see generally clarke, supra note 6. 325 see id. at 307. 326 see id. 327 id. (quoting jonathan d. springer, corporate constituency statutes: hollow hopes and false fears, 1999 ann. surv. am. l. 85 (1999).). 328 id. 329 see supra section iii(d)(1). 330 see kanig, supra note 8, at 875. 170 indiana health law review vol. 12:1 . . [i]t is a two-way dependency.”331 as yogi berra said, “[t]his is like déjà vu all over again.” for the necessarily limited purposes of this article, the seemingly endless contours of this discussion will be confined to a brief characterization of the three most currently-prominent forms of hybrid legal structures: the “flexible purpose corporation,” the “low-profit limited liability company,” and the “benefit corporation.” 1. the flexible purpose corporation the flexible purpose corporation (fpc) was introduced in california in early 2010 as senate bill 1463.332 the central feature of an fpc is a requirement that its articles of incorporation “identify at least one special purpose to be considered in determining the best interest of the corporation and its shareholders.”333 in focusing on a “second ‘bottom line,’” in addition to “shareholders’ financial interest,” the directors “will be shielded from potential personal liability for breach of fiduciary duty.”334 this protection goes to the heart of the problem the law’s drafters sought to address—allowing the fpc’s directors to pursue the fpc’s explicitly stated public purpose, even if doing so negatively impacts shareholder wealth.335 although senate bill 1463 did not survive, it was reintroduced as senate bill 2011 in february 2011.336 it was subsequently enacted in october 2011 and became effective on january 1, 2012.337 in view of its recent arrival on the scene, the fpc’s effectiveness in accomplishing its intended objective remains to be seen. 331 see supra section iv(b). 332 clarke, supra note 6, at 318 (citing s.b. 1463, 2010 leg., reg. sess. (cal. 2010) at 1). 333 id. 334 id. at 318 & n.168. 335 see id. at 319. 336 id. at 321. 337 see california flexible purpose and benefit corporations, california business law blog: law office of jonas m. grant, a.p.c. (jan. 1, 2012), archived at http://perma.cc/zhw3-ffmk. 2015 healthcare corporate structure and the aca 171 2. the low-profit limited liability company (l3c) the l3c is not a corporation, as are the fpc and the benefit corporation, but rather is a form of limited liability company (llc).338 the concept was introduced in 2005 by robert lang, “in an effort to increase and diversify capital of organizations pursuing a socially beneficial purpose.” 339 it is considered a nonprofit/for-profit hybrid and has been referred to as “a ‘for-profit entity with a nonprofit soul.’”340 generally speaking, an l3c is required to satisfy three criteria: “(1) it is required to significantly further a ‘charitable’ purpose as defined under the tax law; (2) its significant purposes may not include producing income or appreciating property; and (3) it may not conduct lobbying or political campaign activities.”341 as a new form of legal entity, the l3c was first recognized in vermont in 2008.342 an l3c has a narrower objective than other forms of hybrid legal structures—“to attract capital from ‘private foundations’343 for socially beneficial purposes.”344 that is, private foundation giving for “program related investments” (pris) is often discouraged by complex tax requirements that are expensive and time-consuming to meet.345 l3cs were designed to facilitate compliance with these requirements by incorporating them directly into the entity’s actual legal framework, eliminating (hopefully) the foundation’s need to obtain a legal opinion or irs approval 338 see clarke, supra note 6, at 321. 339 id. at 311. “lang is the ceo of the mary elizabeth and gordon b. mannweiler foundation.” id. at n.97. 340 id. at n.67. 341 lofft et al., supra note 4, at 11 (citation omitted). 342 id. at 10. 343 id. “a private foundation is a specific type of tax-exempt organization that functions generally to make grants to other charitable organizations, like hospitals. the tax law permits private foundations to make certain investments in for-profit ventures that benefit the public and that are generally too risky or provide too low return to entice private investors, known as ‘program related investments’ or ‘pris.’” id. (citing i.r.c. § 4944 (1986)). 344 lofft, et al., supra note 4, at 10. 345 id. 172 indiana health law review vol. 12:1 in advance.346 however, because the irs has yet to officially determine the effectiveness of l3cs in meeting this goal, it remains unclear whether they offer any significant new advantages for pris.347 as of 2013, the l3c was recognized in no more than nine states, with a few others having pending legislation.348 3. the benefit corporation the benefit corporation began as a “project of the nonprofit organization b lab.”349 a white paper discussing the need and rationale for model legislation (and containing the model legislation itself) was drafted by principal authors william h. clark, jr., of drinker, biddle, & reath llp and larry vranka of canonchet group llc.350 kanig provides an excellent, concise summary of this hybrid legal structure: benefit corporations are dual purpose, blended entities, adhering to the mold of dodd's social enterprise theory and the social entrepreneurship movement, with a legal structure that embraces both the pursuit of profit and the material enhancement of the public good. this general legal structure provides a benefit corporation with two distinct advantages over non-profits and traditional corporate entities. first, unlike non-profits, the board of directors may issue dividend payments to shareholders. escaping the non 346 see id. at 10-11. 347 see id. at 11. 348 id. 349 kanig, supra note 8, at 891 (citing the non-profit behind b corps, b corporation, http://www.bcorporation.net/what-are-bcorps/the-non-profit-behind-b-corps (last visited jan. 4, 2014)). 350 william h. clark & larry vranka, the need and rationale for the benefit corporation: why it is the legal form that best addresses the needs of social entrepreneurs, investors, and, ultimately, the public (2013), available at: http://www.benefitcorp.net/storage/documents/benecit_corporation_whi te_paper_1_18_2013.pdf. 2015 healthcare corporate structure and the aca 173 distribution constraint is essential to accessing sufficient financing to compete with traditional corporate entities, while also attracting management talent who desire wealth. second, the benefit corporation also possesses an affirmative statutory mandate to pursue the general public benefit, in addition to any specific public benefits included within the articles of incorporation. this enables benefit corporations to transcend the efforts of corporate social responsibility because they are manifestly enabled to construct positive externalities. the express statutory purpose of the benefit corporation is to distance itself from the shareholder wealth maximization norm that has dominated traditional corporations, to increase transparency in corporate decisionmaking, and to increase accountability for promised social outcomes.351 benefit corporations are said to “remove any lingering doubt left by constituency statutes” regarding director’ liability by protecting directors’ decision-making in both “the ordinary course of business and in the context of takeovers.”352 of perhaps most significance, benefit corporations provide “a framework for ‘mission accountability’—that is, for monitoring and enforcing [their] effective pursuit of their public interest mission.”353 this new corporate form has been described by some as “an entirely new ‘fourth sector,’ joining the ranks of the ‘big three’ sectors of government, business and nonprofits”354 others describe it as “a convergence of the three.”355 as of 2013, twelve states had enacted enabling legislation for benefit corporations, with fourteen 351 kanig, supra note 8, at 891-892 (emphasis added). 352 cummings, supra note 317, at 590. 353 id. 354 cummings, supra note 317, at 582 (citing see david j. siegel, the promise of intersectoral collaboration, in organizing for social partnership 47, 50-51 (2010) (describing “big three” sectors)). 355 id. 174 indiana health law review vol. 12:1 additional states having introduced legislation to do so.356 in most of these states, as well as under the model legislation, benefit corporations are characterized by three principal features: (1) the corporation is required to provide a “general public benefit;” (2) the directors’ fiduciary responsibilities are expanded to include affirmative consideration and pursuit of articulated general and specific purposes beyond simply maximizing shareholder value, and immunity from liability is provided for doing so; and, (3) the corporation is required “to report on its overall social and environmental performance as assessed by a recognized third-party standard that is comprehensive, credible, independent, and transparent.”357 in addition to the reporting requirement described above, most benefit corporation statutes provide a “benefit enforcement proceeding” that allows minority directors and shareholders to bring legal action against the corporation and its majority directors for: ▪ “a failure to pursue the general, or any specific, public benefit purpose of the benefit corporation;” ▪ a director’s violation of an imposed standard of conduct or duty; and/or, ▪ “a failure to deliver or post the annual benefit report.”358 however, because “[t]he true strength of the benefit corporation . . . lies in enforcing . . . the non-shareholder 356 lofft, et al., supra note 4, at 10 (citing benefit corp information center, benefitcorp, http://www.benefitcorp.net/. 357 id. 358 see kanig, supra note 8, at 895. 2015 healthcare corporate structure and the aca 175 interests imposed . . . by the statutes,”359 these enforcement provisions have been criticized for not providing standing to “third-party beneficiaries” (i.e., “non-corporate actors”) who may well include stakeholders with a significant interest in the corporation’s general or specific public benefit purpose(s).360 the tax status of the benefit corporation remains an open question. while the fpc “is essentially a for-profit corporation,”361 the benefit corporation, like the l3c, is “skewed to the side of public benefit rather than profitmaking.”362 nonetheless, despite its arguable advantages in accomplishing both general and specific public benefits, “[t]here are, as yet, no material tax advantages to organizing as a benefit corporation . . . .”363 this may be due in part to the absence of case law in such a newly developing area, and in part to the absence of developed standards for “balancing” the corporation’s public benefit purposes against both each other and the traditional objective of generating some level of profit.364 uncertainties notwithstanding, lofft et al. believe that this hybrid organization offers “some promise in helping bridge the gap that exists between the historic [binary] approach to business structuring in the united states and the reality of the health care market and health care delivery as it exists today.”365 the “forces of change” in health care generally, and the new imperatives of the aca specifically, clearly will: require providers to make substantial upfront investments in new programs, systems, technologies and/or equipment that will deliver efficiencies, improve quality and maximize value over the longer term. they may also 359 see id. at 897. 360 see id. at 896. 361 clarke, supra note 6, at 327. 362 id. 363 see lofft, et al., supra note 4, at 10. 364 see id. 365 see id. at 9. 176 indiana health law review vol. 12:1 require various parties, including insurers, providers, vendors and others, to come together and find new and innovative ways to collaborate and/or integrate—to share knowledge, data and best practices to achieve these objectives. it would seem clear that efforts directed towards improving healthcare quality and maximizing value would have a significant public benefit typical of the public and nonprofit sectors. such efforts and initiatives, however, may require or at least benefit from the involvement, institutional knowledge and capital raising potential of the private sector.366 c. the fiduciary medicine model finally, a recurrent theme throughout this article has been the idea of accountability. accountability is “an obligation or willingness to accept responsibility or to account for one’s actions.”367 the idea is repeatedly found in discussions of the obligations of corporate governance, regardless of corporate form. the relevant point is this: “[f]iduciary law, embodied in common law duties, statutory standards, and equitable principles, is the primary legal mechanism for assuring accountability in american corporations.”368 in this context, “[f]iduciaries are those undertaking a duty to act for the benefit of others as to matters within the scope of their fiduciary relationship:”369 for-profit directors have a fiduciary obligation to maximize shareholder wealth; charitable nonprofit directors have a fiduciary obligation to use the corporation’s assets for the benefit of the community. in health care, the doctor-patient relationship has long 366 see id. (emphasis added). 367 see merriam-webster online dictionary, accountability, http://www.merriamwebster.com/dictionary/accountability ?show=0&t =1385478126. 368 greaney & boozang, supra note 54, at 33 (emphasis added). 369 id. at n.127. 2015 healthcare corporate structure and the aca 177 been recognized as embodying the epitome of fiduciary obligation. this fiduciary obligation derives from “the trust and confidence patients place in physicians to operate in good faith, remain loyal to their patients, and subordinate their own self-interest and the interests of others.”370 moreover, the centrality of this idea in health care reform is obvious—it is imbedded in one of the principal proposed reform mechanisms, the “accountable care organization.” indeed, the very name suggests that this new, integrated, coordinated-care organization itself has a fiduciary obligation to the patients it serves comparable to that historically attributed only to physicians. as rodwin has said: “public policy and market forces are creating pressures for greater physician and provider accountability. and accountability is the core of the fiduciary ideal.”371 this, then, is essentially the “fiduciary medicine model” proposed by dayna b. matthew, vice dean and professor of law at the university of colorado law school.372 matthew’s model embodies a new legal paradigm that she asserts is best suited to “implementing and achieving the goals of the aca”—“to universalize access to health care,” while reshaping the private and public financing markets “and the organizational entities that deliver and control the quality” of health care services.373 the basic idea is to extend those fiduciary obligations (i.e., good faith, loyalty, and due care) that are already well-established in the profession of medicine “to all major participants in the health care industry” who are involved in the direct delivery of health care services to patients.374 such extension is justified by the changes in health care delivery brought about by the development of the “medical industrial complex” and the reality of “new, larger, and more interdependent actors in that medical complex,” 370 matthew, supra note 7, at 726. 371 id. at 737 (citing marc a. rodwin, strains in the fiduciary metaphor: divided physician loyalties and obligations in a changing health care system, 21 am. j.l. & med. 241, 255 (1995)). 372 see generally id. 373 see id. at 718. 374 see id. at 718, 761. 178 indiana health law review vol. 12:1 increasingly engaged in “group-based decision-making” under the new imperatives of the aca.375 vi. conclusions one [question] is whether there is some quality that comes with the nonprofit form that is essential to the field of health care—mission, voluntarism, or something else. in other words, is there something about health care that makes the nonprofit or public form somehow more morally appropriate than the for-profit or investor-owned form? or is an institution's tax status just a means to cope with its environment? but the argument about the rightness or wrongness of entrepreneurial trends is not the only place for us to focus. we should also consider the possibility that the change that is occurring will not reverse. if that is the case, then a real challenge for those interested in health policy is how to assure that the entrepreneurial forces move in directions that will serve the goal of health care for people and that will avoid some of the dangers that we can all recognize are present.376 the deontological status of health care in the united states today lies somewhere between a “public good” and a “right.” it is clear that the aca—by advancing a scheme to provide near-universal access to insurance coverage—is moving the delivery system closer to the “right” end of the continuum. it is equally clear that a significant percentage of the body politic will never subscribe to the idea of health care as a direct, government-provided entitlement. clearly, it was recognition of this fact that led to the compromise position taken by the aca—that americans do have a right to receive health care, but in a free, competitive 375 see id. at 742-743. 376 gray, supra note 101, at 21-22. 2015 healthcare corporate structure and the aca 179 marketplace with a corresponding obligation to pay for it. this obligation to pay for health care departs significantly from the historical tradition of the charitable, nonprofit hospital—a tradition arising from a bygone era when the country’s health care needs could be met wholly through charitable care-giving, institutional or otherwise. such era ended when health care became commercialized as a result of knowledge and technology that exponentially expanded both the complexity and cost of health care services. health care today constitutes a mature “industrial sector,” consisting of a heterogeneous web of participants that includes nonprofit and for-profit service-providers, as well as innumerable sector-supporters. the web is diffuse and disparate, reflecting a high degree of specialization and comprising 17% of the nation’s economy. it is also unwieldy and dysfunctional, and plagued with unintended consequences and counterproductive incentives. the oftensensationalized wayward behavior of some tax-exempt, nonprofit hospitals is but one example of this dysfunction. bad behavior by such hospitals results from misguided efforts to balance the tension between “mission and margin” inherent in the nonprofit form. as senator grassley’s crusade well demonstrates, too many nonprofits have responded to their increasingly competitive, commercialized environment by over-emphasizing margin at the expense of their charitable mission. the traditional threat of losing their tax-exemption has not been an effective deterrent to such conduct. however, to the extent that the aca further reduces the need for charity care by providing broader insurance coverage, the more irrelevant the nonprofits’ traditional mission becomes. it is far from clear, moreover, that the aca’s new community benefit requirements will serve to re-equalize the quid pro quo, further drawing into question the more than $12 billion dollars that nonprofit tax-exemptions cost in foregone governmental revenue. in attempting to address other delivery system dysfunctions, the aca’s new imperatives will further challenge the historical, limited “binary” choice between nonprofit and for-profit organizational forms. that is, the “integrated and coordinated care model” envisioned by the 180 indiana health law review vol. 12:1 aca necessarily will require additional industry consolidation, increased access to capital, closer collaboration between and among system participants, and greater accountability for quality and high-value outcomes. it is for all of these reasons that a new organizational paradigm is here suggested—a specific form of benefit corporation (i.e., a “health care benefit corporation” (hcbc)) expressly designed for health care delivery and predicated upon the concept of mission primacy and the fiduciary medicine model. as a practical matter, the hcbc would be an adjunct to, rather than replacement for, existing nonprofit and for-profit organizations—arguably most appropriate for multi-stakeholder arrangements such as acos. while a complete explication of such a new conceptual entity is beyond this article’s scope, its essential features and advantages can be described.377 first, like all benefit corporations, the hcbc would be a blended, dual-purpose entity having a legal structure that serves to pursue the public good together with profit seeking as the explicit and legally enforceable mission of a single business enterprise. the “public good” in this instance would be unequivocally identified in the corporation’s articles of incorporation as the ongoing and consistent provision of affordable, highquality, high-value, and readily accessible health care services. this would be the organization’s primary mission, which the governing directors and management would (for the first time) have a legally enforceable fiduciary duty to pursue. second, the hcbc would have a subordinate mission of targeted profit seeking and distribution, intended to attract equity investors and management talent, as well as provide access to taxable capital markets. this feature would better facilitate the integration/coordination of the multiple stakeholders needed for successful aco development by, among other things, eliminating the private inurement constraint. third, the organization would receive a modified level of tax benefits appropriate for 377 needless to say, all of these suggested features and characteristics would require the approval of the irs and other relevant regulators. 2015 healthcare corporate structure and the aca 181 its explicitly defined dual mission and more in keeping with the reduced need for charity care expected under the aca. this might, for example, include access to tax-exempt debt markets, as well as continued tax deductions to donors for charitable donations to the hcbc and to the hcbc itself for providing actual “free” care to qualified indigents; but, elimination of “tax-arbitrage” by the hcbc and income (both state and federal), property, sales, and related tax exemptions for the hcbc. it is, perhaps, an idea worth considering. health evolution: (quality equals learning) plus (ethics equals justice) health evolution: (quality = learning) + (ethics = justice) peter j. hammer* introduction ................................ ..... 415 i. the health care (non)system is broken... ...... 416 a. general indictment of health care: cost, quality and access .................................... 417 b. symbolic indictment: medical errors and racial disparities. ................................. 419 1. medical errors ...................... ...... 419 2. racial disparities ..................... ..... 422 ii. what drives the biomedical industrial complex?. 424 a. the balkans of american health care........ .... 424 b. the political economy of health care..... ...... 429 c. the conundrum of asymmetric information............432 d. the limited role law plays in shaping health care ...................................... 434 iii. re-imagining health care quality and ethics ..... 436 a. re-imagining: health care quality = learning......436 b. re-imagining: health care ethics = justice ........... 441 iv. conclusion. ........................... ....... 445 introduction true revolutions are rare. rather, transformative change is often the result of evolutionary processes. unfortunately, there is no guarantee that a system will evolve in positive directions. constructive social evolution requires a complex set of selection mechanisms, feedback loops and built in learning processes. in the absence of an appropriate supportive framework, it is just as likely that a system will stagnate, fracture, disintegrate or grow in maladaptive ways. this essay takes up the challenge to imagine the health care * peter j. hammer is a professor of law and director of the damon j. keith center for civil rights at wayne state university law school in detroit, michigan. indiana health law review "system" in the next quarter century as it relates to issues of quality and ethics and to further explore its implications for law and policy. part i outlines the starting premise that there is, in fact, no functioning health care "system" in america. it is at best a broken system, but may be so lacking in intra-system rationality and coherence as to constitute a non-system or an anti-system. health care in america costs too much, excludes too many and provides insufficient guarantees of safety and quality. the endemic problem of medical errors and patient safety illustrates the high degree of intra-system irrationality and calls for a re-imagining of quality that incorporates notions of learning. persistent health inequalities and racial disparities in health highlight extreme inter-system irrationalities and the failure of biomedical understandings of health to properly interface with notions of public health and the social and economic determinants of health. this crisis calls for a re-imagining of health care ethics that expressly incorporates notions of justice. part ii attempts to better understand the forces that drive the american biomedical industrial complex in an effort to diagnose its systemic failures from an evolutionary perspective. part iii engages in the imaginative exercise of visualizing what health care might look like in a world where quality is associated with learning, ethics is associated with justice and the health care system is consciously approached from an evolutionary perspective. i. the health care (non)system is broken the starting point of analysis in health law must be that if you are looking for the health care system, there is simply no "there" there. merriam-webster's online dictionary defines a system as "a regularly interacting or interdependent group of items forming a unified whole" or "a group of interacting bodies under the influence of related forces <a gravitational system>" or "an assemblage of substances that is in or tends to equilibrium <a thermodynamic system.>"' health care is 1 system definition, merriam-webster online dictionary, http://www.merriam-webster.com/dictionary/system (last visited mar. 18, 416 vol. 10:2 health evolution so lacking in intra-system rationality or coherence that it fails to satisfy the basic characteristics of a unified system.2 moreover, if one imagines how the health care "system" interacts with other systems from a general equilibrium perspective, such as the food system, the job system, the education system, the environmental system and the housing system, one finds a comparable story of inter-system irrationality. biomedical understandings of health stand in isolation from the broader social and economic determinants of health. the biomedical health care system does not even interface effectively with the public health "system," such that there is one. these failures are so well established that they need only be briefly outlined here. a. general lndictment of health care: cost, quality and access the iron triangle of cost, quality and access provides a standard means of evaluating health system performance. boldly stated, the american system fails with regard to each measure. it costs too much. we get too little and we exclude too many. the commonwealth fund has produced a number of comparative studies of organization for economic cooperation and development (oecd) countries in terms of health care costs and outcomes: health care spending in the u.s. in 2008 towered over the comparison countries, both per capita and as a percentage of gross domestic product (gdp). . . . with regard to quality, u.s. performance on a limited set of measures was 2013). 2 peter j. hammer, arrow's analysis of social institutions. entering the marketplace with giving hands., in uncertain times: kenneth arrow and the changing economics of health care 215, 226-27 (peter j. hammer et al. ed., 2003) ("what is more important (and arguably what has been missing in u.s. health policy) is a commitment to intra-system rationality . . . . some of the most important challenges facing u.s. health care policy makers involves the need to impose greater rationality on patterns of clinical practice and processes of technological innovation."). 4172013 indiana health law review variable. five-year survival rates for patients with three types of cancer were relatively high; the u.s. ranked near the middle on in-hospital, case-specific mortality for three conditions within 30 days of admission. the u.s. also had among the highest rates of hospital admissions for five chronic conditions and the greatest number of lower-extremity amputations due to diabetes. these findings suggest that the u.s. health system is not delivering superior results despite being more expensive, indicating opportunities for cross-national learning to improve health system performance. 3 these numbers do not even begin adequately to account for the millions of people who cannot gain access to the health care system. there are more than 50 million uninsured people in the united states. this is the same as the "combined population of oklahoma, connecticut, iowa, mississippi, kansas, kentucky, arkansas, utah, oregon, nevada, new mexico, west virginia, nebraska, idaho, maine, new hampshire, hawaii, rhode island, montana, delaware, north dakota, south dakota, alaska, vermont and wyoming."4 it also points to a troubling reality with the affordable care act (aca). with a broken system that costs too much already for the too few it serves, a health reform strategy that simply increases access without making structural, systemic reforms will not be sustainable. the international data are particularly important because they permit aggregate comparisons of the entire health system's performance. as a system, we deserve a failing grade. no system spends a greater percentage of available gnp on biomedical notions of health care. our performance 3 david a. squires, the u.s. health system in perspective: a comparison of twelve industrialized nations 2 (2011), available at http://www.commonwealthfund.org/-/media/files/publications/issue%20b rief/2011/jul/1532_squiresus_hit sysjcomparison12nations intlbrief v2.pdf. 4 matt miller, gop to the uninsured: drop dead, wash. post (july 10, 2012), http://articles.washingtonpost.com/2012-0710/opinions/ 35488825_1_uninsured-people-uninsured-man-republican-governors. 418 vol. 10:2 health evolution is at best mediocre. at the same time, an unacceptable percentage of americans stand on the outside of the system looking in. just as unfortunate, the system unintentionally harms many of those that it seeks to serve. b. symbolic indictment: medical errors and racial disparities we can go beyond the general indictment and examine two issues that provide deeper insights into systemic failures. these are important substantive issues on their own, but they also have symbolic significance. the first is the endemic problem of medical errors, which highlights issues of intrasystem irrationality. the second concerns racial disparities in health. these categorical health inequities provide a vivid illustration of inter-system irrationalities in health care. 1. medical errors for more than a decade, the problem of medical errors and patient safety has been at the forefront of health policy. the 1999 iom report to err is human reported countless injuries and perhaps nearly 100,000 deaths taking place each year as a result of preventable errors.5 the ensuing decade has witnessed countless public and private initiatives to improve patient safety. nevertheless, few would claim that we have made sufficient progress. 6 5 inst. of medicine, to err is human: building a safer health system 26 (nov. 1999) ("preventable adverse events are a leading cause of death in the united states. when extrapolated to the over 33.6 million admissions to u.s. hospitals in 1997, the results of these two studies imply that at least 44,000 and perhaps as many as 98,000 americans die in hospitals each year as a result of medical errors."). see also inst. of medicine, crossing the quality chasm: a new health system for the 21st century (mar. 2001) (using shortcomings in health care quality to provide a comprehensive critique of medical care in america from a "systems theory" perspective). 6 delos cosgrove et al., a ceo checklist for high value health care 4 (2012), available at http://www.iom.edu/~/media/files/ perspectives-files/2012/discussion-papers/ceohighvaluecheckhst.pdf ("patients are still harmed by medical errors. recent assessments indicate that 10 years after the iom report to err is human estimated that 2013 419 indiana health law review why have we failed to make better progress on this front? it is easy to frame patient safety and medical errors as issues of quality. these issues, however, provide a window into the way the health care system works or fails to work as a cohesive whole.7 medicals errors highlight the dimensions of intra-system irrationality: the fractured nature of the hospital as a health care firm; the hyper-specialization of physician expertise; and the failure to devise effective means of coordination and communication. in addition, medical errors illustrate the lack of the capacity for the existing system to learn and adapt. medical care is becoming increasingly complex. as complexity increases, so does the need to manage resources and information. coordination and cooperation become essential. what is needed in this environment is obvious. the "regularly interacting or interdependent group of items" constituting how health care is organized and financed need to form "a unified whole."8 yet, this is precisely what is so often lacking. its absence, unfortunately, is the cause of countless hospital infections, prescription mishaps and delayed or mis-diagnoses. the lack of system-ness is similarly a major cause of our failure to effectively manage many chronic conditions.9 effective systems, however, do not medical errors cause up to 98,000 deaths in hospitals each year, roughly 15 percent of hospital patients are still being harmed during their stays. poor care coordination places further strain on patients and the system, with roughly 20 percent of discharged elderly patients returning to the hospital within 30 days.") (footnotes omitted). 7 inst. of medicine, to err is human, supra note 5 at 3 ("the decentralized and fragmented nature of the health care delivery system (some would say 'nonsystem') also contributes to unsafe conditions for patients, and serves as an impediment to efforts to improve safety."). indeed the crossing the quality chasm report is organized almost entirely around approaching quality and health reform from the perspective of complex adaptive systems. inst. of medicine, crossing the quality chasm, supra note 5 at 63-67, 309-22. 8 see merriam-webster, supra note 1, for the definition of system. 9 the promotion of "medical homes" is an effort to impose greater systemic cooperation in the treatment of chronic conditions in a system lacking in such cohesiveness. the henry j. kaiser family foundation, focus on health reform: medicaid's new "health home" option (jan 2011), available at http://www.kff.org/medicaid/upload/ 8136.pdf ("many medicaid beneficiaries suffer from multiple or severe chronic conditions vol. 10:2420 health evolution arise accidentally. they require effective organizational structures, regulatory and financial infrastructures, information, incentives and professional socialization. when viewed from this framework, one can start to develop useful intuitions on how particular categories of medical errors suggest deficiencies in particular aspects of system's integrity. coherence, integration and coordination are all important aspects of well-functioning systems. an evolutionary perspective of systems adds one other important consideration the capacity for learning and adaptation. the existence of numerous medical errors highlights the lack of effective system performance. the persistence of medical errors highlights the lack of effective mechanisms for learning, feedback and adaptation. the same errors happen time and time again. different organizational structures have different capacities for learning and adaptation. these are not simple matters. many of the factors impeding effective system performance also forestall the capacity to learn and adapt. the incentive to learn and adapt, for example, is weakened if the reimbursement system provides greater compensation for making a mistake and treating its consequences than fixing it. it is clear, however, that in considering the future of health law in the next quarter century, the capacity for learning and the conditions that facilitate adaptation must become central parts of how we consider health care quality. such re-imagining will necessarily take us further down the road of greater intrasystem rationality. similar lessons could be drawn from the persistence of small area variations in health practices as documented in the dartmouth atlas project. 10 and could potentially benefit from better coordination and management of the health and long-term services they receive, often in a disjointed or fragmented way."). 10 dartmouth atlas of health care, dartmouth atlas project, available at http://www.dartmouthatlas.org/ (last visited mar. 18, 2013) ("for more than 20 years, the dartmouth atlas project has documented glaring variations in how medical resources are distributed and used in the united states."). 4212013 indiana health law review 2 racial disparities medical care is not the only factor contributing to an individual's and a population's level of health. the literature on the social and economic determinants of health demonstrates how income, housing, education, nutrition and the environment influences health outcomes, often in manners more dramatic than one's access to a physician." as a society, we must not only care about how well the health care system functions internally (intra-system rationality or a static equilibrium framework from an economic perspective), we must also care about how the health care system interacts with other sectors that affect health outcomes (inter-system rationality or a general equilibrium framework from an economic perspective). the literature on health inequalities and racial disparities in health provide insight into these issues. health outcomes vary substantially by socioeconomic category and by racial groups, even independent of socioeconomic status.12 as ralph b. everett, president of the joint center for political and economic studies, reminds us: "[not everyone in the united states enjoys the same health opportunities. studies show that minority americans experience poorer than average health outcomes from cradle to the grave. they are much more likely to die as infants, have higher rates of diseases and disabilities, and have 11 world health org. comm'n of soc. determinants of health, closing the gap in a generation: health equity through action of the social determinants of health 1 (2008), available at http://whqlibdoc.who.int/publications/2008/9789241563703_eng.pdf ("the poor health of the poor, the social gradient in health within countries, and the marked health inequities between countries are caused by the unequal distribution of power, income, goods, and services, globally and nationally, the consequent unfairness in the immediate, visible circumstances of people's lives their access to health care, schools, and education, their conditions of work and leisure, their homes, communities, towns, or cities and their chances of leading a flourishing life."). 12 see generally inst. of medicine, unequal treatment: confronting racial and ethnic disparities in health care (2002), available at http://www.iom.edul-/media/files/ report%20files/2003/ unequal-treatment-confronting-racial-and-ethnic-disparities-in-healthcare/disparitiesadmin8pg.pdf. 422 vol. 10:2 health evolution shorter life spans."13 one dramatic illustration of this is the health status of elderly residents in detroit. "detroit area residents age 60-74 are dying at a rate 48% higher than their peers in the rest of the state."14 this is one of the most important civil rights issues of our day, one that will hopefully start receiving the attention it deserves in the next quarter century. unfortunately, the health care system has an incredibly narrow biomedical understanding of the meaning of "health." similarly, the health care system has an incredibly narrow biomedical understanding of "ethics." there needs to be a re-imagining of health care ethics in a manner where the problems of racial disparities in health are viewed first and foremost as ethical concerns. this will require a new medical ethics that expressly incorporates notions of justice. racial disparities in health serve a deeper symbolic function and provide a window into the extreme inter-system irrationality of american health care. 15 if one adopted a general equilibrium perspective and was only concerned about maximizing health outcomes, in equilibrium, the marginal increase in health for every dollar spent in every sector would be the same. assuming we had the metrics to operationalize this "dollar test," how would the health payoff of an extra dollar devoted to the biomedical sector compare with the health payoff of that same dollar devoted to public health, or education, or housing, or food support? if one were to focus on investments in preventative care, at least one study suggests a greater than five-to-one return on investment over a five year period.16 as health care is 13 ralph b. everett, foreword to thomas a. laveist et al, the economic burden of health inequalities in the united states (december 2009), available at http://www.jointcenter.org/hpilsites/all/ files/burdenofhealthfinal_0.pdf. 14 detroit area agency on aging, dying before their time 4 (2003), available at http://www.daaala.org/daaalmedia/dbtt%20 synopsis.pdf. 15 while this article focuses on the socio-economic determinants of health and the need for greater inter-system rationality, serious issues of race and racial inequalities also exist inside the health care system. 16 trust for america's health. prevention for a healthier america. investments in disease prevention yield significant savings, stronger 4232013 indiana health law review trending to consume nearly twenty percent of gnp, if we were only concerned about health, we could achieve better health outcomes by reallocating health dollars outside of the health sector. not only is there deep intra-system irrationality in health care, there is deep inter-system irrationality in health care. the negative effects of this inter-system irrationality fall disproportionately on under-represented minority groups and the poor. as we re-imagine health care in the next quarter century, we need to imagine means to improve the distribution of resources between traditional biomedical and other health-related sectors. we also need to imagine how to better address underlying racial disparities in health. both of these efforts will require a new health ethics better attuned with notions of social justice. ii. what drives the biomedical industrial complex? to imagine the next quarter century, it is necessary to have an idea of where we are now, how we got here and the dynamic processes driving the system. we are starting from the intuition of health care as a dysfunctional system lacking in intraand inter-system rationality, but we need to better understand the interdependent public, private and professional infrastructures that seek to regulate and control the health care system, as well as the internal forces that drive it. to state that a system is dysfunctional is not to say that it lacks power, intensity or drive. it need only be recalled that the essence of cancer is the unregulated growth of cells to appreciate the potential power of dysfunctionality. a. the balkans ofamerican health care the dysfunction of health care has its own geography. balkanization is the antithesis of integration, coherence and synthesis. to balkanize is "to break up (as a region or group) into smaller and often hostile units."17 health law and policy communities, 3 (2008), available at http://healthyamericans.org/reports/ preventiono8/preventiono8.pdf. 17 balkanize defmition, merriam-webster online dictionary, 424 vol. 10:2 health evolution sadly operate in the balkans of american health care.' 8 on the front end, health care finance is divided between public payment and private payment. public payment is further divided between medicare and medicaid. medicare is further divided into parts a, b, c and d. private payment is divided between large-group insurance policies, small-group polices and the absence of payment (the uninsured). on the back end, the balkanization of health finance can be seen in terms of the diverse patients (and therefore payment systems) who may show up in any given physician's waiting room. the dozens of patients seen each day could each pay for a comparable set of services in a completely different manner. the regulation of health care is balkanized through a complex array of state and federal, judicial common law, administrative, statutory and quasi-public professional selfregulatory processes. through traditional state police powers, states control the licensing of health professionals and institutions (to the extent that they do not loosely subdelegate that responsibility to the professions themselves or to professional organizations). states also largely control the regulation of health insurance, unless those regulations affect self-insured employer plans and are therefore subject to federal erisa preemption and almost no regulation at all. by default, the complex rules governing erisa have been ceded to the shifting opinions of the federal courts. the source of federal constitutional authority to act in health care has become a more controversial and momentous question than anyone might have ever anticipated. medicare and medicaid are an outgrowth of the spending power, but also prove that substantial strings come attached to the receipt of federal funds. for example, medicare and medicaid have their own standards for participating organizations and efforts to ensure quality, that run in parallel to state regulations and state common law malpractice suits. furthermore, outdated and ill-suited forms of medicare http://www.merriam-webster.com/dictionary/balkanize (last visited mar. 18, 2013). 18 peter j. hammer, competition and quality as dynamic processes in the balkans of american health care, 31 j. health pol. pol'y & l. 473 (2006). 4252013 indiana health law review reimbursement necessitate byzantine rules governing selfreferrals, kickbacks and false claims, along with tremendous efforts to combat fraud and abuse. a real but often hidden cost of these rules is the extent to which laws fighting fraud and abuse in public payment systems have constrained the evolution of organizational forms and limited economic innovation on the private side of the health care system. the fractured balkans of american health care also includes robust private markets for physician services, hospitals, pharmaceuticals and medical devices. but, sadly, private competition in dysfunctional systems will often (efficiently) produce dysfunctional results. what are the implications of a balkanized anti-system on private organizational forms and economic forces? i have written elsewhere about the puzzle that the traditional nonprofit hospital structure presents from the perspective of coase's theory of the firm. 19 rather than coming under common ownership and control, the human (physician), physical (hospital) and financial (insurance) capital associated with the financing and delivery of health care services has traditionally been broken up and divided into separate economic parts. in essence, the basic units of payment and production became, themselves, mini-balkans. the incentives (good and bad) of this fractured structure can be contrasted with the incentives of a more integrated unit of production where human, physical and financial capital are under unified ownership and control, such as the kaiser health system or the henry ford health system. one can theoretically take an even greater step towards systemic coherence by imagining the integrated unit as a form of mutual insurance, where ownership and control was vested in the insured themselves. 20 the same economic function can be operationalized in many different organizational forms, but specific organizational forms matter because organizational 19 peter j. hammer, medical antitrust reform: arrow, coase and the changing structure of the firm, in the privatization of health care reform 113, 117-18 (gregg bloche ed.) (2003). 20 one further step could envision the same structure unified under public ownership and control in a single payer system where individual preferences were exercised by votes rather than dollars. 426 vol. 10:2 health evolution structure governs individual incentives. differently organized units will have radically different sets of interests and objectives. a corollary lesson is the more divided and balkanized the system, the more difficult it can be to ensure that all costs and benefits are effectively internalized in any faction's decision making. what are the implications of a balkanized anti-system on the evolution of organizational forms? well-functioning private markets can create strong incentives for dynamic efficiency and the evolution of organizational forms and contracting practices that improve welfare. that said, predictions are dangerous. early in my career, based on the coasian logic suggested above, i predicted the evolution of managed care into increasingly tighter forms.21 this did not happen. instead, we have observed patterns of herding and cycling on the private side of the market moving towards and then away from tighter forms of integration. 22 the paradox is partially resolved when one appreciates the many ways that the balkans of american health care can impede normal evolutionary processes. the absolute din of conflicting payment plans reflected in the physician's waiting rooms drowns out the ability of any one set of financial incentives, even medicare's, to drive organizational forms. the medicare rules governing self-referrals and fraud and abuse are designed to remedy defects in medicare's own payment system, but have the unintended side effect of constraining evolutionary paths on the private side of the market. as a result, private evolutionary potential is not realized. one can view current efforts to establish accountable care organizations, (acos) as a romantic hope and a prayer to obtain the end results of rational adaptation and evolutionary processes, without the underlying infrastructure necessary to enable its creation. if one cannot transcend the negative forces of balkanization, the aspirations of acos will not be realized. ironically, if one could transcend the constraints of the balkans, acos would not be necessary. in the absence of rational adaptation, one should expect various forms of maladaptation. if one wants to understand 21 medicalantitrust reform, supra note 19 at 118. 22 balkanization ofamerican health care, supra note 18 at 485-88. 4272013 indiana health law review what is really driving the biomedical industrial complex, one needs to come to terms with two underappreciated phenomena.23 the first concerns how health insurance is radically different from most other forms of insurance. indeed, health insurance is not insurance at all, it has been transformed into a vehicle of health finance. john nyman develops this argument in his article, the value ofinsurance: the access motive.24 traditional insurance serves the function of (1) pooling like risks and (2) shifting risk. individuals use insurance, in essence, to transfer money from healthy states of the world to unhealthy states. they will continue to buy insurance to transfer such money until the marginal rates of substitution are equalized in all possible states of the world. insurance in this traditional framework is subject to the initial budget constraint of the individual insured. traditional insurance cannot create a greater expected value in an insured state than exists in the original state. contrast this with how health insurance works for those lucky enough to be able to access the system. nyman argues that people use health insurance to buy "access" to care they could not otherwise afford.25 he provides an example of an individual earning $50,000 who needs a $300,000 liver transplant that exceeds their income, assets and ability to finance care through traditional commercial means.26 health insurance becomes a vehicle to collectively finance health care, not a vehicle of pooling or shifting risk.27 this has radical implications for the potential economic metastasizing of the biomedical industry. the largest driver of health care cost is technology. at the complex interplay between insurance and technology, sherry glied, has coined the term "dynamic moral hazard."28 there 23 peter j. hammer, diagnosing america ' health care ills: analysis beyond epithet, 15 mich. st. j. med. & l. 337, 338-40 (2011). 24 john nyman, the value o/insurance: the access motive, 18 j. health econ. 141 (1999). 25 id. at 150. 26 id. at 144. 27 id at 150. 28 sherry glied, health insurance and market failure since arrow, in uncertain times: kenneth arrow and the changing economics of health care, 103 (peter hammer, et al., eds. 2003). 428 vol. 10:2 health ievolution are strong access incentives from health insurance, without comparable mechanisms for internalizing the costs of decisions in individual decision makers. consequently, at the front end, insurance creates incentives for additional research and development. at the back end, insurance contains few active means of technology assessment and, in fact, significantly speeds the diffusion and use of new technology, creating additional profit and incentives for future r&d dynamic moral hazard. all the while, insurance contains few individual incentives for cost control. indeed, in a perverse form of bootstrapping self-blackmail, given the rising costs of health care technology, individuals continue to buy insurance to gain accessing to the future technology that they otherwise would be unable to afford. b. the political economy of health care in some respects, the balkans of american health care presents a misleading image. in the actual balkans, the sharp rugged mountains, valleys and coastlines are concrete geographic realities. in the balkans of american health care, these barriers, divisions and obstacles are our own pathdependent creations. what are the forces that enable the cocreation of such structures and how might they change? one can picture the health care system being jointly shaped by (1) political, (2) market and (3) professional processes. figure one a k political fritic. 1 health care system profe -vket(ci so& 4292013 indiana health law review the simultaneous interplay of market, political and professional processes co-create the health care system.29 markets and politics present complementary processes for aggregating social preferences and allocating resources.30 from this perspective, they serve more similar functions than most people realize. health care becomes particularly complicated given the important role of specialized knowledge (physician expertise), the inherently decentralized manner in which health care must be dispensed and the corresponding role of professionalism. 31 an important lesson from institutional economics is that the same social function can be performed though many different public, private and hybrid organizational forms. given this fact, how does one choose between competing forms? here, economic sociology is more helpful in addressing these questions than more popular forms of public choice theory. one needs to engage in a power analysis. actors will rationally manipulate market, political and professional processes to obtain their desired objectives. antitrust law has sensitized us to the ways in which private market power can be exercised to detrimental ends in the private domain. as such, markets have the potential to yield socially desired objectives or to be coopted for private ends. similar observations can be made of political processes. there is an inherent capacity for political processes to be used to pursue desired social objectives, but there is also the capacity to be coopted for private ends. this would suggest the need for potentially greater scrutiny of the substantive results of political processes. it should be remembered that monopolies, at one point, were dispensed by the crown. comparable issues are raised today in the field of economic development. despite the biases of neoclassical economics, well-functioning markets cannot exist without 29 peter j. hammer, the architecture of health care markets economic sociology and antitrust law, 7 hous. j. health l. & pol'y 227, 237-51 (2007) (applying the lessons of economic sociology to health care and stressing the role of politics, markets and professionalism). 30 id. at 229. 31 see id. at 238-39 (discussing the complexities of the health care market). 430 vol. 10:2 health evolution appropriately robust public infrastructures. development is a simultaneous process of state-building and market-building.32 in this process, the market must be protected against the inclinations of a predatory state and institutional constraints must exist to limit the capacity of political processes to expropriate private resources. at the same time, public processes must be protected against cooption by private economic interests. 33 stated differently, comparable institutional constraints must exist to ensure that public action is in fact in the public interest. ironically, pursuant to the "state action" doctrine, american antitrust law largely assumes that state action is in the public interest.34 this is not a concession that antitrust law in developing countries can necessarily make, where the predatory inclinations of the state are sometimes more transparent. the assumption that state action is necessarily in the public interest is also of questionable historical validity as applied to american medical markets, where state laws, driven at the behest of the medical profession, substantially inhibited the growth of pre-paid health plans and the evolution of better functioning health care markets.35 indeed, the robustness of present market forces is in large part the result of the unintended consequences of federal erisa preemption. 36 back to our triangle in figure one, federal erisa preemption limited the ability of medical professionalism to coopt state political processes to restrict the growth of medical markets and managed care in the 1980s and 1990s. the shape of the health care system has been and continues to be the contested product of complicated interplays between market, political and professional processes, the dynamics of which needs to be the subject of more careful study and examination. 32 see generally daron acemoglu & james robinson, why nations fail: the origins of power, prosperity, and poverty (2012) (contrasting politically and economically inclusive institutions that are conducive to economic growth with politically and economically exclusive institutions that restrict economic growth). 33 the architecture of health care markets, supra note 29 at 261-62. 34 id. at 259. 35 id. at 249. 36 id. 4312013 indiana health law review c the conundrum ofasymmetric information while the forces shaping the health care system are difficult to model and largely under-determined, there are aspects of health care that do make it different from other sectors. as acknowledged by kenneth arrow as far back as 1963, one key aspect is the role of asymmetric information.37 asymmetry of information (uncertainty) in health care is real and helps shape the contours of the industry.38 physicians have specialized knowledge that patients lack. patients face fundamental uncertainties about what treatments to choose and the efficacy of the treatments they select. there is no guarantee that the treatment provided will be effective and there is no market to insure against the risk of failed treatment (non-marketability)39. some types of uncertainties are endemic and irresolvable. moreover, when one adopts an evolutionary perspective, yet a new type of uncertainty must be recognized. given the rapid changes in the health care environment, there are additional asymmetries in the capacity to understand and interpret the nature of change itself. it is possible to make some generalizations about the differential effects of asymmetric information for the market, political and professional processes shaping the health care system. significant asymmetries of information tend to disempower market processes, as well as political processes. this is significant. simply transferring a problem laden with uncertainty and asymmetric information from the market realm to the political realm does not necessarily make it easier to address, as acknowledged by mark pauly's nontransformation theorem.40 to paraphrase crassly, an ignorant consumer is also an ignorant voter. the 37 kenneth j. arrow, uncertainty and the welfare economic of medical care, 53 am. econ. rev. 941 (1963). 38 id. at 946. 39 id. at 945, 951-52. 40 mark v. pauly, is health care different., in competition in the health care sector: past, present, and future (warren greenberg, ed., 1978) 11, 24 ("the mere transfer of the locus of choice from the market to the political process does not transform consumers into better judges of quality, nor does it necessarily improve the decisions made."). 432 vol. 10:2 health evolution asymmetries do not get resolved simply by changing the forum. analysis must go deeper to assess the relative abilities of the competing fora to manage and address the underlying uncertainty. this fact leads to the next generalization. asymmetries of information tend to empower parties that can claim legitimacy in interpretation and understanding. historically, this has been the role of the learned professions and a central thesis of paul starr's analysis of the rise of physicians in controlling both markets and politics for most of the twentieth century.41 what might these lessons mean for the future of health care? the endemic nature of asymmetries of information must be examined in combination with the inherently decentralized nature of health care production and consumption. information is intrinsically difficult to translate into a commodity that can be traded on the open market (non-marketability).42 interestingly, the education and licensing of doctors and the historic branding of the profession served as an effective means of bundling and selling information in the form of the individual licensed physician, making the information a marketable commodity. the individual physician as the central unit of production, however, has had its own limits and inefficiencies. as illustrated by the colorful maps of the dartmouth atlas's small area variations, physician-based units of production are not very effective units for scientific learning or the dissemination of best practices. as information systems progress and comparative effectiveness research proceeds, there need to be new and better ways to bundle information that will make the individual physician's role less central. as the unit of health care production moves from an individualbased unit to a health-system-based unit, information will be bundled, branded and sold at the systems level. this is consistent with broader trends that have persistently deprivileged the individual doctor in the production process.43 41 paul starr, the social transformation of american medicine: the rise of a sovereign profession and the making of a vast industry 9-10 (1982). 42 arrow, supra note 38 at 946. 43 see peter j. hammer, how doctors became distributors: a 2013 433 indlana health law review these informational transformations could lay the basis for a complete restructuring of the way health care is organized and delivered (a different solution to arrow's conundrum of the non-marketability of information). the same transformations have political implications as well. as individual physicians lose their role as the authoritative interpreters of medical information, they also lose the political power and legitimacy that being the arbiters of asymmetric information entailed. this, in turn, will lead to further shifts in the market, political and professional processes collectively defining the shape of the health care system. d. the limited role la w plays in shaping health care what role does health law play in shaping the health care system? the role of health law and health lawyers is fairly limited. to begin with, law is constrained by the domain of the issuing regulating authority. there is a simple mantra that to be effective, the scope of the regulatory unit must map onto the scope of the regulatory problem. given the breadth of the health care system and the balkanized nature of federal, state and local authorities, the nature of the health care problem often eludes the scope of any given public entity's ability address the issue. the contested debate over the constitutionality of the affordable care act tragically underscores that reality.44 matching the nature of the regulatory units and the regulatory problems could certainly be done better than it is today, but it will always remain a unique challenge in the united states. those that teach health law understand a related frustration. health law tends to lag the industry, not lead it. the law we teach our students often feels like it is twenty years out of date. i realize that some practitioners will find fabled story of vertical relations, 14 loy. consumer l. rev. 411, 412-13 (2002). 4 see generally nat'l fed'n of indep. bus. v. sebelius, 132 s.ct. 2566 (2012) (rejecting the claim that the affordable care act could be based on federal commerce clause authority, but finding the act to be a legitimate exercise of the federal government's taxing authority). 434 vol. 10-2 h ealth evolution these statements controversial, but the existing tort system does very little to substantially improve patient safety or reduce errors. the tools employed for quality regulation, licensing, accreditation and malpractice, are ad hoc, incomplete and of limited effectiveness. similarly, the theoretical notions underlying traditional approaches to quality are first generational and fairly primitive in light of contemporary advances in health services research. fortunately, the affordable care act makes a number of advancements in this regard.45 the health care industry is changing much more rapidly than the legal environment, which raises interesting questions about the comparative adaptive ability of legal, economic and political processes. why does law tend to lag and not lead? has health law itself been sufficiently nimble and adaptive in a changing economic environment? lawyers and law professors must accept some level of humility. law is often not intended to be innovative. moreover, law is often structured to protect existing power systems. from this perspective, health law tends to descriptively track the superstructure of the biomedical complex itself. it is not on the vanguard of change. moreover, law and lawyers are often called into service to help shore up the weakest and most dysfunctional parts of the system. if one could subject the health care system to a legal equivalent of a magnetic resonance image (mri), areas of high density or concentration of law would often signal likely pathologies. again the rules governing self-referrals and fraud and abuse come to mind. this dense concentration of laws, rules and regulations is intended to remedy dysfunctionalities embedded in the payment system itself. if the system of reimbursement were redesigned in a more rational manner, while one would still need a set of legal rules to police opportunistic and strategic behavior, the density of that set of rules on our imaginary mri would be much lighter. in practice, this means that one will typically observe changes in the evolving structures first and see changes in the legal regime second. 45 see discussion infra notes 53-56. 2013 435 indiana health law review iii. re-imagining health care quality and ethics the task of imagining the next quarter century of health care law is different from trying to predict what the next quarter century of health care law will look like. the task of re-imaging is different still. it calls for deeper creative skills and the visualization of paths open but not yet taken. the difficulty is that we reside in a dysfunctional system. the best and most accurate prediction, given existing power structures and trajectories, suggests that the future will be some maladapted version of the dysfunctional present. standard acts of imagination will likely fall victim to the same problem, if the act of imagining is rooted within the confines of existing systems. an act of re-imagining focuses on the same problem but seeks to creatively address concerns from a perspective that transcends existing structures.46 to be practical, however, it must also be grounded in evolutionary considerations that credibly link the re-imagined world with the one we find today. a. re -imagining: health care quality = learning how can we re-imagine health care quality? the problem of medical errors was used earlier to symbolically highlight problems from inside the health care system. the visualization exercise is to ask: what would patient safety look like in a system designed to foster greater intra-system rationality? a consideration for greater intra-system rationality calls for a greater awareness of and sensitivity to the many ways that elements of the health care system are interconnected. we are trained to see separate parts as separate parts. the structure of the system is often designed to highlight differences and not connections. artificial 46 this is not just fanciful musing. serious people are beginning to give serious attention to the cognitive and social processes necessary to engender systemic transformations. see, e.g., peter senge, et al., presence: an exploration of profound change in people, organizations, and society (2005) (providing a meditation on the cognitive, personal and social processes that are conducive to transformational change). for an application to health care see id. at 15457. 436 vol. 10:2 health evolution barriers in terms of corporate structures, legal status and reimbursement policies are imposed to further increase the divides. when the need for greater system thinking does arise, the answer is to form a new committee or, better yet, to establish a separate department to address the systemic deficiency. the patient safety movement is significant, in part, because the very logic of the movement forces participants in the process to view health care as a system and to engage in deeper systems thinking. this has significant transformative possibilities. at the heart of the environmental movement lay a new awareness of the ecosystem as not just a system, but a complex adaptive system. this awareness highlighted issues of interconnectivity, new understandings of multiple and joint causation, as well as the significance of inflection points and feedback mechanisms. this awareness helped transform environmental law and environmental policy. the patient safety movement has similar radical potential. unfortunately, after highlighting the issue of medical errors and calling for systemic analyses and approaches, the patient safety movement has failed to meet its real potential. part of the problem is structural. while actors can try to change policies within those parts of the balkans they actually influence and control (the coasian-fractured hospital systems in which they operate), they face greater challenges obtaining necessary and complementary changes in other domains, such as reforms in reimbursement policy, medical school training and state malpractice laws that are also part of the systemic problem. in a complex, interrelated system, changes in one subsystem are often insufficient to trigger the meta-level changes that are sought and can sometimes produce unintended negative consequences. in the balkans of american health care, it is often difficult, costly and impolitic to implement the system-wide reforms necessary to advance positive evolutionary change, even when the bases for such change are well developed and well understood in one fractured part of the system. this suggests a related problem. the systems thinking characteristic of the patient safety movement is largely cabined to its own domain. 4372013 indiana health law review unlike the fundamental understanding of ecosystems in environmental policy, systems-thinking does not yet pervade the health care sector. to date, there are also shortcomings within the patient safety movement itself. while it understands the importance of learning and building learning into systems to remedy medical errors, it has yet to effectively operationalize learning processes at individual and organizational levels. it interesting to note how the focus on medical errors in the iom's report to err is human led to a greater appreciation of quality more broadly and the significance of complex adaptive systems in health care writ large in crossing the quality chasm.4 7 awareness of greater systems thinking led to a greater appreciation for the role of learning. citing the work of peter senge, the iom argued that "moving toward the health system of the 21st century will require that health care organizations successfully address the challenge of becoming learning organizations." 48 learning, in turn, requires data and information. "a critical feature of learning organizations is the ability to be aware of their own 'behavior.' in organizational terms, this means having data that allow the organization to track what has happened and what needs to happen-in other words, to assess its performance and use that information to improve."49 learning and awareness can form the catalyst for growth, adaptation and change. however, the challenges to creating effective learning organizations are great. few organizations inside or outside health care are effective in institutionalizing processes of progressive adaptation. as such, this part of the patient safety agenda remains unfulfilled. what is needed is creative re-imagining. what would patient safety look like in a system designed to foster intra-system rationality? what are implications for health law? what changes would be necessary to facilitate this process? what pictures would you draw to highlight new 47 inst. of medicine, crossing the quality chasm, supra note 5 at 63-67. 48 id. at 135 (referencing peter m senge, the fifth discipline: the art and practice of the learning organization (1990)). 49 id. at 136. 438 vol. 10:2 health evolution pathways and interconnections? what are the logical implications for the rest of the health care system? how could these changes be implemented in a manner that progressed the agenda as part of a natural, ongoing evolutionary process? it is clear that greater "systems thinking" must be part of the answer. there is good news in this regard. the health systems thinking reflected in crossing the quality chasm does not stand in isolation. under the rubric of health systems development, there is a growing literature that examines "health systems" as a cohesive unit.50 this particular literature originated from the challenges facing developing countries, particularly as it relates to balancing the objectives of vertically oriented global health initiatives, such as the global fund to fights aids, tuberculosis and malaria, and the local objective of health systems development.51 nevertheless, the international call to create a new science of health system development has direct implications for the systems orientation necessary to transforming the balkans of american health care and to implement a sustainable quality improvement agenda. there are other promising developments on the domestic front in the progressive quality components of the affordable care act (aca). a number of these provisions expressly focus on quality as a learning problem.52 parts of the aca are 50 see world health organization, an assessment of interactions between global health initiatives and country health systems, 373 lancet 2137, 2140 (2009); healthy development: the world bank strategy for health, nutrition, and population results, the world bank 170-71 (apr. 24, 2007) available at http://siteresources.worldbank. org/healthnutritionandpopulation/resources/2816271154048816360/hnpstrategyfinalapril3o2007.pdf, see also world health org., systems thinking for health systems strengthening world health organization, alliance for health policy and systems research & world health organization (2009) available at http://whqlibdoc.who.int/publications/2009/9789241563895eng.pdf. 51 peter j. hammer & charla m. burill, global health initiatives and health system development: the historic quest for positive synergies, 9 ind. h. l. rev. 567 (2012). 52 see, aca provisions with implications for a learning health system, institute of medicine of the national academies, http:// iom.edu/-/media/files/activity%20files/quality/vsrt/summary%20of/20 4392013 indiana health law review devoted to the production of new knowledge through comparative effectiveness research. in addition, the aca plugs into a growing infrastructure to work the quality agenda, such as the center for quality improvement & patient safety.53 this work seeks to be appropriately sensitive to cultural and organizational considerations. the creation of knowledge alone is not enough. knowledge must be used in practice and underlying patterns of behavior must be changed.54 as the patient safety movement has learned, sensitivity to the issue in isolation is not enough. the entire health care system must be oriented to the new objectives, particularly the incentives embedded in reimbursement. positive change is not limited to the aca. the 2009 stimulus package contained numerous provisions to improve information systems and electronic records.55 while the program is far from perfect, it is a significant step in the right direction. asymmetries in information were identified earlier as the most significant challenge to rationally organizing the health care system through either market or political processes. successful efforts to better manage available information flows in health care could prove a more lasting and more effective reform than the collective provisions of the aca. that said, we have still not developed proper understandings on how that information can best be packaged and used by either patients or health care providers. it all comes back to the need to re-imagine health care quality around the theme of learning and adaptation, but building learning organizations is easier in theory than in aca%20impact%20on%20the%201earning%20healthcare%20system.pdf (last visited mar. 19, 2013) (working background document developed by leigh stuckhardt of the iom roundtable on value & science-driven health care that has not been subject to the review processes of the national academies). 53 mission statement: center for quality improvement and patient safety, agency for healthcare research and quality (feb. 2004), http://www.ahrq.gov/legacy/about/cquips/cquipsmiss.htm. 54 mission statement: office of communications and knowledge transfer, agency for healthcare research and quality (mar. 2008) http://www.ahrq.gov/legacy/about/ockt/ocktmiss.htm. 55 see jessica holzer & gerard anderson, increasing hit through the economic stimulus bill, health pol'y monitor (2009), available at http://www.hpm.org/us/bl3/3.pdf. 440 vol. 10:2 health evolution practice. b. re -imagining: health care ethics = justice how can we re-imagine health care ethics? the problem of racial disparities in health was used earlier to symbolically highlight concerns between the health care system and other health-related sectors of the economy. these disparities highlight the significance of the socioeconomic determinants of health and the need for greater inter-system rationality. an appreciation of inter-system rationality calls for a greater sensitivity to the many ways that elements of the health care system are interconnected with other sectors, such as housing, education, food security, transportation and employment. again, we are trained to see separate parts as separate parts. in truth, health is generated from the interaction of numerous forces, of which the biomedical components are just a small part. unfortunately, there is no movement inside the biomedical industrial complex pushing the issue of racial disparities that is comparable to the patient safety movement. even if one looked at the entire resources devoted to public health, let alone the fraction seriously devoted to racial disparities, it constitutes a drop in the bucket compared to the resources that flow through private health care system. the re-imaginative work here is more daunting than that of quality/safety, where most actors are already ostensibly dedicated to the same cause. re-imagining health care ethics will take more energy and educational awareness. the key insight is the need to establish a new understanding within the existing bioethics framework that openly focuses on notions of justice. one can start with the visualization exercise: what would racial inequalities look like in a system designed to foster inter-system rationality? what pictures can you draw to facilitate better understanding of the socioeconomic determinates of health? what are the deeper lessons of the racial disparities in health? what do they teach about issues of injustice in health care and in the rest of society? what enabling environment is necessary to address these concerns 2013 441 indiana health law review and what would be needed to enable the enabling environment? what are implications for health law? what new understandings would be necessary? what changes would be needed to existing doctrines? again, the path forward requires a greater understanding of how complex systems work and how they interact. there are interesting advancements in understanding the mechanics of structural racism that parallel research on health system development. the kirwan institute has published work examining structural racism from the perspective of complex adaptive systems.56 the intersection of these research agendas can be the starting point of developing the tools and methodologies necessary to create greater inter-system rationality in health care and take effective actions to address health inequalities and racial disparities in health. traditional understandings of medical ethics are too narrow and need to be expanded. bioethics typically address the individual, in their personal and not their social context (assuming that the individual is lucky enough to gain access to the biomedical industrial complex at all). moreover, while issues of access and justice are discussed in the health law literature; they are seldom framed expressly as ethical concerns. we need new understandings of ethics that embrace notions of social justice and advocate expressly for an ethics of inclusion. it is striking how sterile and detached existing ethical and professional discourses can become. one illustration concerns scope of practice laws. what is "ethical" quickly gets wrapped up in professional rules and state licensing laws. historically, many of these practices had the dual effects of restricting access to certain types of providers and increasing costs.5 7 sometimes this was done for legitimate technical considerations, sometimes it was done to enhance the profitability of the favored group. what is the appropriate re-imagined ethical frame? in a 56 stephen menedian & caitlin watt, systems primer draft, kirwan institute (dec. 2008) http://kirwaninstitute.osu.edu/docs/ systems-thinking-and race-primerjuly2009.pdf. 57 peter j. hammer, medical code blue or blue light special.' where is the market for indgent care?6 j. l. in society 82, 95 (2005). 442 vol. 10:2 health evolution world where we are unwilling to commit to principles of universal access, limiting the scope of practice necessarily increases the price of health care and decreases access to service.5 8 this has a disproportionate impact on the poor, which include disproportionate numbers of minority groups. those that advocate for expanding scope of practice laws or consciously making available sets of lower cost options for traditionally excluded groups run the risk of being labeled "unethical." at the same time, the existence of 50 million uninsured persons largely excluded from any meaningful health services may broadly be thought of in ethical terms, but not specifically conceived of as an issue of bioethics. there are reasons to be hopeful with the passage of the aca. the aca expands the scope of coverage for many presently uninsured and provides them access to the traditional health care system.59 the aca also aggressively pushes traditional scope of practice laws to permit new combinations of health care workers to provide services. 60 this should benefit under-served communities. in addition, the aca makes a dedicated effort to start collecting and analyzing data on racial disparities in health care and establishes a new administrative infrastructure for future policy action.61 to begin to address the underlying causes of racial disparities in health, however, we have to move substantially beyond the notion of simply increasing access to the biomedical industrial complex. we need to imagine new conceptualizations of health. traditional public health 58 id. at 95-96. 59 states that choose to do so may categorically extend medicaid benefits to those under 1.33% of the federal poverty level. various forms of subsidies to purchase individual and small group policies will be given to those with incomes less than four-times the federal poverty level that purchase their insurance through newly created health exchanges. 60 the future of nursing: focus on scope of practice, institute of medicine (oct. 2010), http://www.iom.edul-/media/files/ report%20files/2010/the-future-of-nursing/nursing%2scope%20of% 20practice%202010%2obrief.pdf. 61 dennis p. andrulis et al., patient protection and affordable care act of 2010: advancing health equality for racially and ethnically diverse populations, 3-5 (july 2010) (joint center for political and economic studies). 2013 443 indiana health law review models are a good starting point and serve as a bridge between the biomedical model and the socioeconomic determinants of health. sadly, the ties between health care and public health are historically weak and frayed; another illustration of the balkanization of health care. before public health can become a bridge, public health institutions must themselves be strengthened. again there is reason to be hopeful. while still mired too deeply in the biomedical model, the aca signals a stronger commitment to public health and preventative care than past reform efforts. 62 these, however, are just small steps forward. much more needs to build from this foundation. on the other side of the bridge, there must be deeper notions of community-based health and recognition of the need to strengthening communities themselves. many underserved communities are in increasingly abandoned urban areas with frayed public infrastructures and weakened civil society institutions. meeting the varied health needs of these communities will require strengthening the communities themselves and empowering them to be meaningful partners in forging their own futures. again, we can find inspiration from abroad. many global health initiatives in developing countries also work in challenging circumstances where public, market and civil society institutions are weak or nonexistent. in this setting, new doctrines of "community system strengthening" have been developed that can be an inspiration to future american efforts to connect the health care systems to the social determinants of health through public health institutions and community system strengthening. 6 3 there is another frame that can help visualize the process. in figure one, the dynamics of health care was portrayed as a triangle with political, market and professional processes 62 see lance gable, the patient protection and affordable care act, public health, and the elusive target of human rights, 39 j. l. med. & ethics 340 (2011). 63 hammer & burill, supra note 52 at 627-31 (detailing the global fund's approach to community system strengthening); see also, global fund, community systems strengthening framework (may 2010) (same), available at www.who.int/entity/tb/dots/comm-hss.pdf. 444 vol. 10:2 health evolution shaping the health care system. in some respects, community system strengthening seeks to wrest control of health away from the elusive domain of the professionals and return it to a more traditional model of state-market-civil society, where professional associations are simply one of many civil society actors. health must become everybody's business. i am a pragmatist, not an idealist. for these re-imagining exercises to be meaningful there must be a defensible pathway plausibly connecting the imagined possible state with the dysfunctional state of affairs observed today. the template necessary to effectively engage the socioeconomic determents of health to address racial health disparities through community system strengthening is similar to the template needed to better address chronic illnesses like diabetes and asthma. the locus of treatment for many chronic illnesses must be moved out of the biomedical industrial complex and re-situated in the community. effective universal cost control for health care will require these types of community-based health interventions and a better understanding of health determinants that would prevent the precipitation of medical episodes. the heightened recognition of this connection, in addition to the justice-based ethics discussed above, can create a credible pathway for future actions on health inequalities and racial disparities in health in our re-imagined world of quality and ethics for the next quarter century. iv. conclusion twenty-five years ago, few could have completely envisioned the range of health law and policy issues we face today. the same will be true twenty-five years from now. that said, creatively re-imagining our approaches to patient safety and to racial disparities will not only address two of the most pressing policy issues we face today, it could also hold the key to systemic transformation. patient safety cannot be improved without an appreciation for organizational learning and intra-system rationality. racial disparities necessitate a focus on an ethics of justice and inter-system rationality. 4452013 indiana health law review both agendas will have to transcend the geography of the balkans and will run head long into the political, market and professional forces that define and defend the biomedical industrial complex. at the same time, even the defenders of the system must acknowledge the dysfunctional and unsustainable state of affairs. what makes the re-imagining exercises in this essay more than fanciful is the desperate need for improving the system itself. from this perspective, progress on patient safety and racial disparities can be instruments triggering cascading evolutionary changes improving the functioning of the entire system. changes in complex adaptive systems are not restricted to discrete, isolated domains, especially when the changes themselves are conceptualized and implemented in a manner that seeks greater intra-system and inter-system rationality. while intraand inter-system rationality have been discussed as distinct principles, it should be clear that these objectives are themselves interrelated. the ultimate imaginative task will be to increasingly merge the agendas of intraand inter-system rationality in an unfolding evolutionary scenario. the path forward for the next quarter century of health law is clear. for the meaningful evolution of the health care system to take place, "quality must equal learning" and "ethics must equal justice." 446 vol. 10:2 your money or your lifestyle!: employers' efforts to contain bealthcare costslifestyle discrimination against dependents of employees? brendan w. miller* table of contents i. introduction ............•............................•....................•.......•............•. 372 ll. the rising cost of healthcare ..................................................... 373 a. trends in employment-related health insurance costs ........... 373 b. effect of rising healthcare costs on employers ....................... 374 c. effect of rising healthcare costs on employees ...................... 375 iii. employer responses to rising healthcare costs ................... 376 a. employers' interests .................................................................. 376 b. make employees pay for their "vices" or do not hire them in the first place ............................................................ 376 1. examples ............................................................................. 377 a. clarian health partners ............................................... 3 77 b. weyco, inc .................................................................... 377 c. cook v. rhode island .................................................... 378 2. requiring employees to bear the costs versus not hiring applicants .............................................................. 379 c. spouses and other dependents of employees .......................... 379 iv. distinction between the employee and the employee's spouse or dependent, with respect to health insurance ..................................................................................... 380 a. the nature of employer-sponsored health insurance ............. 380 b. third party beneficiary law ..................................................... 382 v. employer control of off-duty conductlifestyle discrimination? ........................................................................... 383 a. employer control of off-duty employee conduct .................... 383 b. lifestyle discrimination concerns ............................................ 385 c. extending restrictions on off-duty conduct to spouses and other dependents of employees ....................................... 387 vi. protections against lifestyle discrimination ....................... 387 a. protections for employees ......................................................... 388 1. state protection ................................................................... 388 2. federal protection .............................................................. 389 * j.d. candidate, 2007, indiana university school oflawindianapolis; b.s., 1996, manchester college; m.s.w., 1998, indiana university. 372 indiana health law review [vol. 5:371 a. employee retirement income security act of 1974 ("erisa'') ................................................................... 390 b. health insurance portability and accountability act of 1996 ("hip aa '') .............................................. 390 c. proposed federal legislation ......................................... 393 b. protection for employees' spouses and dependents ................ 396 vii. alternatives for healthcare cost containment •.........•...... 397 a. evolution ofhealthcare plans .................................................. 397 b. alternative cost-cutting strategies ........................................... 399 viii. conclusion .........•........•.............•..............•...........•......................•. 400 i. introduction jack and jill are married and have a daughter named sally. jack works for the smith agency, which provides health insurance coverage for employees and their dependents. jack, jill, and sally are enrolled in the health plan. to encourage healthy lifestyles, the smith agency instituted a wellness program entitled "healthy living." the program includes an array of smoking cessation activities consisting of pamphlets, classes, and support groups. to bolster the efficacy of the smoking cessation component, the smith agency recently insti­ tuted a no-smoking policy under which employees will be subjected to periodic screenings for the presence of nicotine in their systems. empioyees testing pos­ itive for nicotine will be asked to pay a higher premium for their healthcare coverage. having realized some healthcare expenditure savings since institut­ ing the nicotine screenings, the smith agency is now planning to expand the program to encompass non-employees covered under their health plan. faced with the reality ofhigh healthcare costs, employers continue to seek creative ways to curb those costs. the strategy deployed by the smith agency is not dissimilar from strategies being explored and used by many employers. if these strategies are effective for lowering healthcare costs for the employer and for those employees and other beneficiaries who do not engage in "risky'' or ''unhealthy'' behaviors, don't they just make good business sense? what if em­ ployer policies extend to tracking less stigmatized vices than nicotine? if the smith agency were to begin testing to ensure jill was not consuming ''un­ healthy" levels of caffeine and to make sure sally's intake of snacks did not include too many sweets or salty treats-would that be going too far? at what point do the legitimate business interests of the employer give way to concerns about invasion of privacy rights of the employees' dependents covered under the employer's health plan? this note addresses these issues, first, by providing an overview of the rising costs of healthcare and the effect it has on employers and employees. next, notable responses employers have to rising costs are discussed; including not hiring applicants with unhealthy habits or risky behaviors, or making these 2008] your money or your lifestyle! 373 employees pay for their habits or behaviors by shifting more of the cost of healthcare to these employees. the following section compares the status of employees with the status of spouses and other dependents of employees cov­ ered under the same employer health plan to determine how, or if, the two groups are distinguished in any legally significant way with respect to their rights under an employer-sponsored health plan. then, the notion oflifestyle discrimination that results from employers controlling employees' off-duty be­ haviors or habits that may be risky or unhealthy is examined for its applicability to spouses and other dependents of employees. additionally, state and federal protections against lifestyle discrimination are discussed. finally, this note ad­ dresses alternative strategies for employers to cut healthcare costs. ii. the rising cost of healthcare national spending on healthcare continues to rise. nationwide healthcare spending amounted to two trillion dollars in 2005; this amount equates to ap­ proximately $6700 per person 1 and represents nearly one-sixth of the gross do­ mestic product? total health expenditures in 2005 rose by 6.9%, or twice the rate of inflation. 3 spending on healthcare is expected to continue to rise over the next ten years reaching four trillion dollars in 2015, or twenty percent of the gross domestic product. 4 a. trends in employment-related health insurance costs about 158 million non-elderly americans are covered by employer­ sponsored health insurance. 5 in 2007, sixty percent of firms offered health ben­ efits to at least some of their employees. 6 the percentage of firms offering health benefits has fallen since 2000, when sixty-nine percent of firms offered benefits.7 health insurance premiums are on the rise, though at a slower pace than in recent years. in the spring of 2007, premiums for employer-sponsored health insurance had risen by 6.1% over the previous year, a decrease from the 7.7% 1. nat. coal. on health care, health insurance cost 1 (2006) [hereinafter nat. coal. on health care], available at http://www.nchc.org/facts/2007%20updateslcost.pdf (citing a. catlin et al., national health spending in 2005,26 healthaff. 1, 142-53 (2006)). 2. /d. 3. /d. (citing catlin et al., supra note l, at 142-53). 4. !d. (citing c. borger et al., health spending projections through 2015: changes on the horizon, web exclusive, w61 healthaff. 22, (2006)). 5. thek.aiserfam.found.&healthres.&eouc. tr.,employerhealthbenefits: 2007 summary of findings 1 (2007) (citing kaiser comm'n on medicaid & the uninsured, health insurance coverage in america, data update (kaiser fam. found., menlo park, c.a.), 2005), available at http://www .kff.orglinsurance/7672/upload/summary-of-findings-ehbs2007.pdf. 6. id. at4. 7. /d. 374 indiana health law review [vol. 5:371 increase in 2006.8 the 2007 increase is the lowest rate of growth since 1999, when premiums increased by 5 .3%. 9 the changes in premium rates are experi­ enced differently by different workers, though. in 2007, forty-six percent of covered workers worked for firms where premiums increased five percent or less, while ten percent of covered workers worked for firms where premiums increased more than fifteen percent. 10 though the rate by which premiums have increased has slowed, premiums far outpaced overall inflation (2.6%) and wage gains (3.8%). 11 b. effect of rising healthcare costs on employers rising healthcare costs have had a profound effect upon employers. "health insurance expenses are the fastest growing cost component for employ­ ers. unless something changes dramatically, health insurance costs will over­ take profits by 2008."12 the increases in healthcare spending over the last five years has cut into operating margins and reduced the capacity of businesses to grow through investment in research, capital spending, product development, and marketing. 13 high health insurance costs hinder job growth by making it more expensive for companies to add new employees or retain their existing employees.14 between 2000 and 2005, employers' health insurance premiums increased about seventy-three percent, but wages increased only fifteen percent during the same period.15 consequently, american businesses have a competi­ tive disadvantage with foreign competitors that have operations in countries with universal health insurance programs and slower healthcare cost inflation.16 in response, some american businesses have joined together, on a national basis, to develop solutions to the problem of rising healthcare costs. 17 small businesses are disparately affected by rising health care costs. most midsize and large businesses offer health benefits, but thirty-eight percent of workers are employed in smaller businesses, where less than two-thirds of firms 8. !d. at 1. 9. !d. 10. !d. 11. !d. 12. nat.coal.onhealthcare,supranote 1. 13. nat. coal. on health care, the impact of rising health costs on the economy: effects on business operations 2-3 (2006), available at http://www.nchc.org /facts/economy/costs-business%200perations.pdf. 14. !d. (citing henry j. kaiser f am. found., employee heal til benefits: 2005 ann. survey (2005), available at http://www.kff.org/insurance (last visited feb. 20, 2008)). 15. !d. 16. !d. general motors adds over $1500 to every car and truck made because ofhealth­ care costs. julie appleby & sharon silke carly, ailing gm looks to scale back generous health benefits, usa today, june 24,2005, at bl. 17. see generally inst. on healtii care costs & solutions, national business group on healrn, available at http://www.businessgrouphealth.org/healthcarecosts/institute .cfin (on file with the author). 2008] your money or your lifestyle! 375 offer health benefits to their workers. 18 since 2000, high health insurance costs have resulted in 266,000 firms-most of which employ fewer than twenty-five workers-no longer offering health insurance coverage. 19 compelled by pre­ mium increases, many small firms which do continue to offer health insurance have shifted a greater portion of these costs to their employees.20 "employees in small firms who have family coverage contributed nearly $1100 more a year for premiums than their counterparts in larger firms."21 many low-wage work­ ers have elected to do without coverage due to the high costs. 22 c. effect of rising healthcare costs on employees high health insurance premiums have left millions of workers with no health insurance coverage "because many employers cannot afford to provide health benefits."23 even when employers provide health insurance, many work­ ing families cannot afford the employee's portion of the premiums.24 "workers on average pay 27 percent of the premium. "25 the compounding effect of high health insurance costs means that wage growth lags, and employees' gains in take-home pay are substantially reduced. 26 clearly, the magnitude of healthcare costs is impacting employers and employees collectively and as individual groups. the nature of the employment relationship is affected by the trend of rising costs. therefore, employers have been and will continue to develop responses to healthcare costs to maximize their interests. 18. see nat. coal. on health care, the impact of rising health costs on the economy: effects on small businesses 1 (2006), available at http://www.nchc.org/facts/ economy/costs-small%20businesses.pdf( citing u.s. gen. accountability office, private health insurance: small employers continue to face challenges in providing coverage (2001 ), available at http://www.gao.gov/new items/do28.pdf; henry j. kaiserfam. found., the uninsured: a primer, key facts about americans without health insurance (2006), available at http://www.kff.org/uninsured (last visited mar. 14, 2008)). 19. !d. at2-3 (citing henry j. kaiserfam. found., employeehealthbenefits: 2005 ann. survey (2005), available at http://www.kff.org/insurance (last visited mar. 14, 2008)). 20. !d. 21. id. 22. !d. deductibles paid by small firm employees are also significantly higher than de­ ductibles paid by larger firm employees; compared to large firm employees, small firm employ­ ees enrolled in preferred provider organization plans pay deductibles that are one-hundred percent higher when using in-network providers and sixty percent higher for out-of-network providers. !d. 23. nat. coal. onhealthcare, thelmpactofrlsing healthcostsontheeconomy -effects on workers and families 1 (2006), available at http://www.nchc.org/facts/ econ­ omy/costs-workers&families.pdf. 24. ld. at 2 (citing henry j. kaiser fam. found., employee health benefits: 2005 ann. survey (2005), available at http://www.kff.org/insurance (last visited mar. 14, 2008)). 25. !d. 26. !d. (citing council of econ. advisors, econ. update, achievements, and 0bjechvesfornffifuture-a white paper, (2005)). 376 indiana health law review [vol. 5:371 iii. employer responses to rising healthcare costs a. employers' interests given the rising costs of health insurance, employers have incentive to encourage healthy lifestyles in their employees. lost hours of work due to sickness or other reasons take a toll on the employer's bottom line. moreover, some employees are more likely to cause extra expenses for their employers (e.g., employees needing special accommodations related to disabilities or spe­ cial work hours).27 even employees who have legitimate reasons for being ab­ sent from work can, however, cause productivity problems for employers. indeed, if the absence is caused by illness or injury claims can be brought against the employer's health plan as well as claims for paid sick leave.28 addi­ tionally, employee conduct away from the workplace can also impact the work­ place. thus, even activities employees carry out during the normal course of everyday living-eating, drinking, smoking, driving, etc.-may conflict with the interests of the employer.29 b. make employees pay for their "vices" or do not hire them in the first place employers are increasingly seeking to limit their healthcare cost burdens by adjusting their hiring practices and discouraging unhealthy habits.3° for example, employers have implemented non-smoker hiring policies citing the benefits oflimiting healthcare costs, banning workplace smoking, and avoiding the hiring of people who are likely to be absent more than average.31 citing concern for higher healthcare costs, some employers may even use candidates' private eating habits as a factor to disqualify them from employment. 32 27. stephen d. sugarman, "lifestyle" discrimination in employment, 24 berkeley j. emp. & lab. l. 377,383 (2003). 28. id. 29. /d. at 391. 30. see, e.g., joe robinson, light up, lose your job, l.a. times, feb. 19,2006, atm3; shaunti feldhahn & diane glass, do companies have the right to dictate workers' health habits?, buffaw news, feb. 12, 2006; cami reister, clearing the air: companies go to new lengths to stomp out tobacco use, the grand rapids press, sept. 25, 2005, at h 1; shirleen holt, companies increasingly saying smokers need not apply, sea tile times, oct. 10, 2004. 31. sugarman, supra note 27, at 391. 32. /d. at 392. 2008] your money or your lifestyle! 377 1. examples33 description of some particular cases is helpful to illustrate the types of policies being adopted by employers in response to rising healthcare costs: a. clarian health partners clarian health partners, an indiana-based hospital chain, made national headlines in 2007 when it announced a policy aimed at trimming both health­ care costs and the prevalence of overweight workers within its ranks.34 other employers have adopted policies to create incentives for healthy behavior or make overweight employees pay if they do not lose weight. 35 "in one of the boldest moves yet, [clarian health partners] said it decided on the stick rather than the carrot."36 according to its announced policy, beginning in 2009, cla­ rian health partners will charge employees up to thirty dollars every other week unless they meet weight, cholesterol and blood-pressure guidelines set by the company and deemed to be healthy. 37 several weeks after the announcement, however, clarian health partners made some concessions to place more emphasis on the carrot and less on the stick. 38 after listening to feedback from employees, the company now plans to "offer incentives on employees' health insurance premiums for meeting certain parameters for known health risks including smoking, high body mass index (bmi), blood pressure and cholesterol."39 b. weyco, inc. weyco, inc. is a michigan-based company.40 weyco's president, howard weyers, was concerned about healthcare costs related to smoking.41 as are­ sult, prior to 2005 weyers informed his employees they would be charged a 33. limitations on the ability of employers to implement such policies vary by jurisdic­ tion. see text accompanying notes 124-81. 34. daniel costello, workers are told to shape up or pay upto hold down medical costs, some firms are penalizing workers who are overweight or don't meet health guide­ lines, l.a. times, july 29,2007, at al. 35. !d. 36. !d. 37. /d. 38. raquel bahamonde, employees call for change; clarian listens, inside ind. bus., sept. 13, 2007, available at http://www .insideindianabusiness.com/newsitem.asp?id==254 3 5# middle (last visited mar. 14, 2008). 39. !d. 40. nat. workrights inst., lifestyle discrimination: employer control of legal off duty employee activities 5 (2006), available at http://www.workrights.org/issue_life style/ldbrief2.pdf. 41. !d. 378 indiana health law review [vol. 5:371 fifty dollar smoking fee; the fee would be waived for employees who passed a nicotine test or, if they failed, agreed to take a smoking cessation class.42 with assistance from a company-sponsored smoking counselor, about twenty em­ ployees successfully quit smoking. 43 weyers' policy change included an ulti­ matum that employees must quit smoking by january 1, 2005.44 after that date, weyco began mandatory testing for nicotine; employees who failed the test would be fired. 45 weyco's smoking policy raises issues regarding both an employer's abil­ ity to discriminate with respect to an employee's lifestyle choices and the pri­ vacy rights of employees. 46 "with new policies such as weyco' s, which allow an employer to test for the existence of legal products in an employee's sys­ tem-in weyco' s case, tobacco-society must ask itselfhow much discrimina­ tion on the basis of lifestyle is it willing to tolerate from employers?"47 c. cook v. rhode island bonnie cook worked as an attendant at a facility for mentally disabled persons from 1978 to 1980, and again from 1981 to 1986.48 both times she departed voluntarily without blemishes on her work record.49 in 1988, cook reapplied for an identical position.50 at that time, "she stood 5'2" tall and weighed over 320 pounds."51 during a routine pre-hire physical, a facility nurse concluded that, though cook was morbidly obese, her condition did not impinge upon her ability to do the job. 52 although cook passed the physical examination, the facility claimed her obesity would limit her ability to move patients in case of emergency and put her at greater risk of developing serious illness; the facility refused to hire cook. 53 cook won her suit against the facil­ ity under a claim that the facility violated the prohibition against handicap dis­ crimination contained in the rehabilitation act of 1973.54 while these examples do not exhaustively cover the array of employer re­ sponses addressing high healthcare costs, they demonstrate two of the main strategies available to and utilized by employers: (1) avoidance of cost (by not hiring employment candidates who engage in risky or unhealthy behaviors); 42. /d. at6. 43. id. 44. id. 45. id. 46. ann l. rives, note, you're not the boss of me: a call for federal lifestyle discrimination legislation, 74 geo. wash. l. rev. 553, 554 (2006). 47. id. 48. cook v. rhode island, 10 f.3d 17, 20-21 (1st cir. 1993). 49. id. 50. id. 51. id. 52. id. 53. id. 54. cook v. rhode island, 10 f.3d 17,20-21 (1st cir. 1993). 2008] your money or your lifestyle! 379 and (2) limiting cost (by shifting a portion of the higher costs to those employ­ ees who choose to engage in risky or unhealthy behaviors). 2. requiring employees to bear the costs versus not hiring applicants some argue that requiring employees with unhealthy lifestyles to bear the increased health costs associated with their behaviors (e.g., charging employees a higher premium) is preferable to refusing to hire them as employees. 55 this solution still arguably subjects the employee to an invasion of privacy. 56 a smoker, for example, "would still be required to disclose her status as a smoker in order to gain employment."57 this proposed solution also risks subjecting employees to a slippery slope by which employers may use other risky behav­ iors or activities as cause for terminating or reducing the employee's health in­ surance. 58 an employer interested in reducing healthcare costs would have incentive to discover employees' unhealthy habits to gain the benefit of con­ tinuing work product from the employee while reducing health care costs. 59 c. spouses and other dependents of employees as employers look for strategies to reduce healthcare costs, costs associ­ ated with non-employees covered under the employer's health care plan consti­ tute an area of potential savings. weyco, inc. has already expressed interest in extending its cost-cutting strategies to spouses of its employees.60 for example, weyco' s president wants to extend the employee smoking ban to spouses of his employees.61 health-testing of spouses would accompany the smoking ban; if the non-employee spouse smokes, the insurance premium charged to the em­ ployee will be raised significantly. 62 the reality is that non-employees covered under an employer's health plan can incur just as much expense as employees. as employers look for creative solutions to rising costs, other companies are likely to follow the path ofweyco. a key question is how, and whether, non­ employees are distinguishable in any legally significant way from employees covered under the same employer health plan. 55. michele l. tyler, note, blowing smoke: do smokers have a right? limiting the privacy rights of cigarette smokers, 86 geo. l.j. 783, 795 (1998) (citing helen halpin schauffler, health insurance policy and the politics of tobacco, in smoking policy: law, politics, and culture (robert l. rabin & stephen d. sugarman eds., 1993)). 56. tyler, supra note 55, at 795. 57. id. 58. id. 59. id. 60. 60 minutes two (cbs television broadcast, july 16, 2006) (transcript on file with the author). 61. id. 62. severe smoking bans in some workplaces (cnn television broadcast, dec. 9, 2005) (transcript on file with author). 380 indiana health law review [vol. 5:371 iv. distinction between the employee and the employee's spouse or dependent, with respect to health insurance a. the nature of employer-sponsored health insurance most private healthcare coverage is provided through employment, but this reality did not necessarily come about by design. 63 prior to the 1940s, rela­ tively few employers offered health insurance benefits to their employees.64 this changed, though, during world war ii when government-enacted wage controls forced employers to entice employees by providing benefit packages, including health insurance, in lieu of higher wages. 65 this practice became widespread and was even endorsed by the american medical association which had decided that private health insurance was preferable to the national public health insurance alternative being debated at the time. 66 the federal government made changes to the tax code in 1954 to further support employer­ sponsored health insurance; employers' contributions to employees' health in­ surance coverage were deductible by employers and excluded from taxable in­ come for employees. 67 because health insurance was also a legally proper subject for collective bargaining purposes, the ties between health benefits and employment were solidified and an explosion in employment-based health in­ surance was released. 68 in 1940, only twelve million people were enrolled in group hospital insurance plans; by 1955, the number had grown to 101 mil­ lion.69 employer-sponsored health insurance typically takes the form of group in­ surance. some discussion of the basic parameters of group insurance helps put into context the benefits for employees and their spouses or dependents. gen­ erally, group insurance refers to the coverage of a number of individuals through a single, comprehensive policy. 7° contract law defines a group insur63. laura d. hermer, private health insurance in the united states: a proposal for a more functional system, 6 hous. j. healm l. & pol'y i, 10 (2005) (citing thomas boden­ heimer & kevin grumbach, paying for healthcare, 272 jama 634, 636 (1994)). 64. /d. (citing paul starr, social transformation of american medicine 290-334 (1982)). 65. /d. (citing thomas bodenheimer & kevin grumbach, paying for healthcare, 212 lama 634, 636 (1994); paul starr, social transformation of american medicine 311 (1982)). 66. id. (citing thomas bodenheimer & kevin grumbach, paying for healthcare, 212 lama 634, 636 (1994); paul starr, social transformation of american medicine 280-89 (1982)). 67. /d. (citing john g. day, managed care and the medical profession: old issues and old tensionsthe building blocks oftomorrow 's healthcare delivery and financing system, 3 conn.ins. l. j. 1, 15 n.50 (1996)). 68. /d. 69. /d. at 11. (citing thomas bodenheimer & kevin grumbach, paying for healthcare, 272 jama 634,636 (1994)). 70. 44a am. jur. 2d insurance § 1828 (2006) (citing romano v. new eng. mut. life 2008] your money or your lifestyle! 381 ance policy as a contract between an insurer and an entity for the benefit of a group of people with some relationship to that entity. 71 group policies are typi­ cally interpreted as creating an insurance contract "between the employer and the insurer'' intended to benefit individuals employed by the employer.72 employees that obtain coverage through such group policies with their employers may have limited autonomy in choosing the type of coverage they desire.73 the employer has primary responsibility for choosing a plan.74 a 2003 study showed that sixty-eight percent of all firms offering health insur­ ance offered only one plan choice. 75 the smaller the firm's size, the more like­ ly the choice of plans will be limited. while"[ s ]ixty-nine percent of firms with fewer than 200 employees offered only one health insurance plan ... [only] 20% of firms with five thousand or more employees" restricted the choice to only one plan.76 in resonance with the theme of this note, cost is the single largest factor determining which plan(s) an employer chooses to offer.77 the results of one study revealed that eighty percent of all firms surveyed cited cost as "very important" in determining which plan( s) to offer employees. 78 on the other hand, only forty-five percent of firms questioned in another survey con­ sidered employee satisfaction with the plan to be ''very important" in determin­ ing which plan(s) to offer.79 even so, studies suggest employees are more confident in their employer's choice of health plans then they are in choosing a health plan themselves. 80 even with sometimes limited options in health plans, employers typically provide coverage for employees' dependents. the cost of such coverage, though, drives some employees to elect not to take advantage of the available health plans. 81 typically, employers pay the bulk of the individual coverage cost for their employees. 82 however, employers often pay less for the depend­ ent's insurance premiums then it will for the employee. 83 the result is that an employee shoulders a far greater cost for dependent coverage than for her own ins. co., 362 s.e.2d 334, 338 (w. va. 1987)). 71. /d. (citing in re: louisiana health service and idem. co., 749 so. 2d610, 614(la. 1999)). 72. /d. (citing alsup v. travelers ins. co., 268 s.w.2d 90, 94 (tenn. 1954)). 73. henner, supra note 63, at 20. 74. /d. 7 5. /d. (citing employer health benefits: 2003, ann. survey (kaiser fam. found., men­ lo park. cal.), 2003, at 64, available at http://www.kff.org/insurance /ehbs2003-abstract.cfin (last visited mar. 14, 2008)). 76. /d. 77. /d. 78. /d. 79. /d. 80. id. at 21. 81. /d. at 19. 82. /d. at 16-17. 83. /d. at20-21 (citingpaulfronstin,emp. benefits res. inst., sourcesofhealtii insurance and characteristics of the uninsured: analysis of themarch2004 current population survey 14 (2004)). 382 indiana health law review [vol. 5:371 coverage. 84 according to a 2005 study, six percent of all employers offering health insurance paid less than fifty percent of their employees' premiums.85 the cost shifting is even greater with smaller employers; thirty-five percent of employers with fewer than two hundred employees paid less than fifty percent of dependents' premiums.86 b. third party beneficiary law because employer-sponsored group health insurance policies are "con­ strued as creating a contract of insurance between the employer and the insurer, [] for the benefit of the insured employees,"87 third party beneficiary law is im­ plicated in understanding the respective rights of employees and dependents regarding the insurance policy. the restatement of contracts provides that "a promise in a contract creates a duty in the promisor to any intended beneficiary to perform the promise, and the intended beneficiary may enforce the duty.'.s8 the intention of the parties to the contract is determinative; if the parties in­ tended to benefit a third party through the contract, the third-party has rights as an intended beneficiary. 89 so long as the third-party beneficiary is ascertain­ able, the contract need not name the beneficiary specifically. 90 the beneficiary, as a member of a class of persons, may be recognized as a third-party benefici­ ary as long as the class is sufficiently described or designated.91 although the beneficiary must be identified before she has an enforceable right as a third par­ ty beneficiary of a contract, she need not be identified or identifiable at the time the contract is made.92 the respective contractual rights of employees and their dependents, then, depend upon construction of the employer-sponsored healthcare policy. as previously stated, group health policies are usually construed as being a con­ tract between the employer and the insurer for the benefit of the employee. employees are third party beneficiaries of the policies; the construction of the contract clearly indicates that such policies are being interpreted as intended for 84. /d. at 20. 85. /d. (citing thomas bodenheimer & kevin grumbach. paying for healthcare, 272 jama 634, 636 (1994); paul starr, social transformation of american medicine 311 (1982)). 86. /d. 87. 44a am. jur. 2d insurance§ 1828 (2006) (citing alsup v. travelers ins. co., 268 s.w. 2d 90,94 (tenn. 1954)). 88. 17aam. jur. 2d contracts§ 440 (2006)(citingrestatement(second) of contracts§ 304 (1981)). 89. /d. at§ 430 (citing hrusbka v. state, dep't. of pub. works & highways, 381 a.2d 326, 326 (n.h. 1977)). 90. /d. at§ 443 (citingmk w. street co. v. meridienhote1s inc., 184a.d.2d312, 312 (n.y. app. div. 1992)). 91. /d. at § 436. 92. /d. at§ 443 (associated teachers of huntington, inc. v. bd. ofeduc., 306 n.e.2d 791, 791 (n.y. 1973)). 2008] your money or your lifestyle! 383 the benefit of employees. indeed, the historical development of employer­ sponsored health insurance gives witness to the fact that employers intention­ ally entered into contracts with insurers in order to provide health benefits that would entice employees to join their firms. as further enticement to employ­ ees, employers took advantage of the tax code to provide health coverage to employees' dependents. absent specific language in an insurance contract be­ tween the employer and the insurer that states a different intention, employees and their dependents have the same standing with respect to employer­ sponsored health insurance; all are third party beneficiaries. v. employer control of off-duty conductlifestyle discrimination? a. employer control of off-duty employee conduct with the reality of rising health care costs, finding ways to reduce or redis­ tribute the burden of those costs is a legitimate employer interest. making em­ ployees with unhealthy habits or risky behaviors pay higher premiums requires employers to discover those habits and behaviors. employers exert at least in­ direct control over employees' off the job conduct through imposition of a pol­ icy for discovery which discourages employees from engaging in unhealthy habits and risky behaviors. certainly, direct restrictions of employee behavior (e.g., on-duty and off-duty smoking bans) reflect employer control of off-duty employee conduct. most reasonable people will agree that employers should be given latitude in imposing restrictions on employee on-duty behavior, but those same people may disagree as to the degree to which employers' interests should justify control over employees' off-duty behavior.93 employers generally follow two approaches, often used in combination, to control off-duty conduct of employees in advance and to punish what the em­ ployer deems to be unacceptable off-duty conduct upon its occurrence. 94 the first approach is to adopt and give notice of rules that specify what off-duty conduct is forbidden; these rules tend to be based on forecasts that the forbid­ den conduct is likely to lead to financial harm for the employer.95 the second strategy is to develop and utilize a more general policy stating that employees are forbidden from conduct that brings harm to or threatens to bring harm to the employer.96 the general policy statement is usually used to allow employers more discretion to protect their interests against unexpected events that might not be fully accounted for in a narrow rule forbidding specific conduct. 97 93. sugannan, supra note 27, at 380. 94. id. at 398. 95. /d. at 398-99. 96. id. at 399. 97. !d. 384 indiana health law review [vol. 5:371 without practical guidelines that give notice to employees ofhow a vague gen­ eral policy is likely to be applied, it may be difficult for employees to avoid the very conduct about which the employer is concerned.98 the general policy ap­ proach also raises concern that the employer may wield unfettered discretion that risks unfair application of the policy.99 employers may use various methods for discovering off-duty conduct of employees. the first and perhaps least invasive technique is self-reporting­ routinely asking applicants and employees questions about off-duty conduct and/or instructing employees to come forward when certain conduct occurs. 100 if applicants and employees are candid about their conduct, then self-reporting may allow employers to learn what they want to know directly.101 further, if an employee provides false information on his application, the employer will have legitimate grounds for terminating the employee. a second strategy for discov­ ering off-duty conduct is through indirect sources. if employees know disclo­ sure oftheir off-duty conduct may jeopardize their job, they have incentive to not always be forthright. 102 news accounts or tips from other employees or members of the general public provide indirect evidence of off-duty conduct. 103 while the availability of indirect sources of information may seem to be more a matter of chance, employers might encourage the information by rewarding people who provide tips about observed conduct. 104 searching public and pri­ vate records provides a third approach to discovery.105 finally, employers may use systematic investigations to discover off-duty conduct: physical examina­ tions by physicians, "paper and pencil .. tests of propensity for honesty and/or psychological makeup, and blood, urine, saliva, and breath tests to discover drug use, tobacco use, cholesterol level, blood pressure, and other bodily condi­ tions.106 the use of such screening devices brings the risk ofhigh rates of false negatives; employees may be erroneously identified as having undesirable off­ duty conduct.107 yet, employers may believe the risk is justified.108 98. jd. 99. id. consider, for example, the issue of smokers who are re­ fused employment out of employer fears of high health­ care costs. although employee smokers as a group may make higher average claims on the firm's health care plan than would non-smokers hired in their place, a sub100. i d. at 400. 101. jd. 102. jd. 103. ld. 104. jd. 105. jd. at 400-01. 106. jd. at401. 107. jd. 108. jd. 2008) your money or your lifestyle! stantial proportion of employee smokers might not have higher healthcare claims than the average non-smoking employee who is hired instead. indeed, smokers may be neglectful of their health and most may actually use health care services less than average (so long as they don't suffer from a grave illness). at the same time, a few smokers, not readily identifiable in advance, are likely to be very expensive. as a result ... an employer might conclude that the best and cheapest thing to do would [be] to simply tolerate all the false negatives and refuse jobs to all smokers.109 385 clearly, the issues confronting employers seeking to discover the off-duty con­ duct of employees are especially complex when potentially life threatening be­ haviors like smoking are implicated. b. lifestyle discrimination concerns. company policies intended to address rising healthcare costs by refusing to hire or making employees pay for their unhealthy habits or risky behaviors may pose a threat to the privacy and autonomy of american workers. 110 between the hours of nine and five, the average person's life is not her own. her employer can tell her what to do, and when and how to do it. employers do not have to be polite, or fair. even one's rights as an american citizen largely disappear when one goes through the office door. this situation is tolerable because it is limited to work­ ing hours. few would want to live in a society in which they were subjected to employer control twenty-four hours a day. but this is a very real possibility if employers are permit­ ted to regulate off-duty behavior unrelated to job per­ formance because of its health implication. 111 beyond the commonly cited vice of smoking, many other items consumed by workers pose health risks: caffeine, alcohol, red meat, and sugar. 112 recrea­ tional activities such as skiing, scuba diving, motorcycle riding, water sports, 109. !d. 110. lewis l. maltby & bernard j. dushman, whose life is it anywayemployer control of off-duty behavior, 13 st. louis u. pub. l. r:ev. 645, 645-46 (1994). lll. !d. at 646. 112. ld. 386 indiana health law review [vol. 5:371 and others are risky behaviors as well.113 sleeping habits, sexual activity, and the decision to have children all have health implications, too.114 "indeed, there are few aspects of our lives that will be immune from employer control if this precedent is allowed to stand."115 the united states constitution's bill ofrights and, by its extension to the states through the fourteenth amendment, is the basis for privacy rights and the prohibition of unwarranted intrusion.116 employee privacy rights for private sector employers have developed through statute, case law and contract.117 "an employee's right to privacy is not completely suspended while at work, how­ ever, nor is an employer's right to control completely eliminated when an em­ ployee is away from work; rather, there is a shift in the privacy-versus-control balance. "118 a prominent scholar on privacy matters has suggested that those individu­ als favoring priority for employees' privacy rights may be divided into two groups, the fundamentalists and the pragmatists. 119 fundamentalists would support the strong presumption that employees' interests in their personal off­ duty autonomy have priority over employers' economic justifications for re­ strictions on employees' private lives.120 pragmatists take a less absolutist ap­ proach, putting considerable weight on employees' interests to act as they wish during their off-duty time without consequences on the job.121 pragmatists ac­ knowledge employer interests but dislike adverse employer decisions based on off-duty behavior they consider to be insufficiently related to the employee's work.122 113. /d. 114. id. 115. /d. how analogous is lifestyle discrimination to those cate­ gories of employment discrimination that are already widely agreed to be properly forbidden by the law, most importantly, discrimination on the basis of race, sex, na­ tional origin/ancestry, religion, age, and disability? in the end, the key question may be whether we feel strongly enough that employers have an obligation to ac­ commodate the employee's private time autonomy (in 116. paul f. gerhart, employee privacy rights in the united states, 17 comp. lab. l. & pol'y j. 175, 176 (1995). 117. ld. 118. id. at 178. 119. sugarman, supra note 27, at 408 (citing alan f. westin, privacy in the workplace: how well does american law reflect american values?, 72 cm.-kent l. rev. 271, 272-73 (1996)). 120. ld. 121. id. at 409. 122. id. 2008] your money or your lifestyle! the fashion that employers have a duty to accommodate the disabled, that is, even at an extra cost to the em­ ployer). in short, how strongly do we value privacy after all, and how wrong do we think it is for employers to run over this interest ofworkers?123 387 comparing lifestyle discrimination with forbidden categories of employment discrimination is a valid consideration in defining privacy rights. it is not diffi­ cult to see a distinction, though, between a protected status concerning which the employee has no choice (e.g., race, gender, age) and a behavior choice (e.g., smoking). c. extending restrictions on off-duty conduct to spouses and other dependents of employees the same interests that guide an employer to reduce or redistribute health­ care costs through policies that track, restrict, and/or impose penalties for off­ duty conduct of employees give incentive for employers to impose similar poli­ cies targeting unhealthy habits or risky behaviors of spouses and other depend­ ents of employees covered under the same health plan. assuming spouses and dependents of an employee covered under the employer's health plan have the same contractual rights as the employee under the plan, the imposition of re­ strictions or control over the non-employees' behaviors or habits poses similar concerns for lifestyle discrimination as are present for the employee. addition­ ally, employer policies targeting non-employees may present risks of a slippery slope: does the imposition of such policies provide incentive for employers to gain information about non-employees not covered under the health plan (e.g., spouses or dependents who smoke and, therefore, contribute to the covered em­ ployee's health risks related to second-hand smoke)? would such policies cre­ ate incentive for employers to gain broad information about the covered beneficiaries' living environment (e.g., residing in an area that subjects benefi­ ciary to more exposure to allergens or general pollution; residing in a neighbor­ hood that is "less safe" than other neighborhoods)? vi. protections against lifestyle discrimination given the increasing trend of employers controlling off-duty conduct of employees and the pressures facilitating employers' control of health-related conduct of employees' dependents, what protections are in place or could be engaged to prevent discrimination and invasion of privacy? 123. id. at413-16. 388 indiana health law review [vol. 5:371 a. protections for employees 1. state protection there is no uniform consensus among the states as to whether a common­ law right of privacy concerning employer-employee relationships should be acknowledged. 124 but, two torts for invasion of privacy have emerged with re­ spect to the off-duty conduct of employees: (1) unreasonable intrusion upon the seclusion of another and (2) unreasonable publicity given to another's private life.125 discrimination against employees who use tobacco and other lawful products when off-duty has grabbed the attention of a larger group of the states. thirty states and the district of columbia have laws prohibiting discrimination against employees who smoke off-site, and thirteen states outlaw bans on off­ duty alcohol consumption. 126 north carolina and some other states include sta­ tutory exceptions for situations in which the use of these lawful products "ad­ versely affects the employee's job performance or the person's ability to properly fulfill the responsibilities of the position in question or the safety of other employees."127 these statutes reflect a willingness to balance the em­ ployee's right to use legal products against the employer's interest in control­ ling off-duty conduct of employees that could affect the workplace. 128 these statutes provide some protection to employees.129 because the scope of the sta­ tutes is limited to the use of certain products, though, many facets of the em­ ployee's off-duty life remain unprotected.130 four states-colorado, north dakota, california, and new york-have enacted statutes that provide protection for a broader range of off-duty con­ duct.131 each of these statutes has serious limitations, though, on the protec­ tions actually afforded to employees.132 colorado's statute protects "any lawful activity'' of the employee done while off-duty, but the protection extends only to current employees.133 because the statute does not address prospective em­ ployees, the law may facilitate the unintended consequence of promoting dis124. rives, supra note 46, at 556 (citing pauline t. fjm, privacy rights, public policy, and the employment relationship, 51 omo st. l.j. 671, 672 (19%)). 125. id. (quotingmarisaannepagnattaro, what do you do when youarenotatwork?: limiting the use of off-duty conduct as the basis for adverse employment decisions, 6 u. pa. j. lab. & emp. l. 625, 631 {2004)). 126. !d. at 558 (quoting kim norris, his ultimatum: quit smoking or lose job, detroit free press, feb. 15,2005, at 1a). 127. ld. {citing n.c. gen stat.§ 95-28.2(b) {2003)). 128. id. (quoting pagnattaro, supra note 125, at 642). 129. id. 130. id. 131. id. at 559 (quoting pagnattaro, supra note 125, at 646). 132. id. 133. ld. {citing colo. rev. stat.§ 24-34-402.5(1)). 2008] your money or your lifestyle! 389 crimination in hiring decisions. 134 north dakota's statute prohibits discrimina­ tion for an employee or prospective employee's "participation in lawful activity off the employer's premises during nonworking hours which is not in direct conflict with the essential business-related interests of the ernployer."135 but, an employee's lawful activity will not be protected under the statute if the activ­ ity is "contrary to a bona fide occupational qualification that reasonably and rationally relates to employment activities."136 in interpreting north dakota's statute, courts have been troubled by the ambiguous "lawful activity" language of the statute.137 for example, in hougum v. valley memorial homes, the court struggled with the meaning of"lawful."138 in that suit, the plaintiff brought a claim against the residential horne where he worked as a chaplain after he was fired for allegedly masturbating in the stall of a department store restroorn. 139 while the chaplain argued that his conduct was a lawful activity, the court de­ clined to hold whether the activity qualified as "lawful. " 140 in his partially dis­ senting opinion, chief justice vande walle expressed that he did not believe the statute "intended to protect as lawful activity off the employer's premises during nonworking hours sexual activity, alone or with others, in a bathroom in a store in a shopping rnall.''141 the ambiguous language of the statute leaves uncertainty as to the type of conduct for which a north dakota employee can be fired. 142 likewise, the laws enacted in california and new york have also been restricted by narrow construction of statutory language which, on its face, seems to provide broad protections for employee's off-duty conduct.143 2. federal protection while no federal statute explicitly protects employees from employer dis­ cipline for off-duty conduct, several statutes protect facets of employees' per­ sonal lives from undue scrutiny.144 four statutes limit the use of off-duty conduct in connection with adverse employment decisions: the immigration reform and control act; the fair credit reporting act; title vii of the civil rights act; and the employee polygraph protection act. 145 additionally, the 134. !d. (quoting jessica jackson, colorado 's lifestyle discrimination statute: a vast and muddled expansion oftraditional employment law, 67 u. colo. l. rev. 143, 143 n.5 (1996)). 135. !d. at 560 (citing n.d. cent. code§ 14-02.4-01, -03 (2004)). 136. !d. (citing n.d. cent. code§ 14-02.4-08 (2004)). 137. !d. at 561. 138. !d. (citing hougum v. valleymem'l homes, 574 n.w. 2d 812,821-22 (n.d. 1998)). 139. !d. (citing hougum, 574 n.w. 2d at 815). 140. !d. (citing hougum, 574 n.w. 2d at 820-22). 141. !d. (citinghougum, 574 n.w. 2dat 823 (vande walle, c.j., concurring in part and dissenting in part)). 142. !d. 143. !d. at 561-63. 144. pagnattaro, supra note 125, at 670. 145. !d. the immigration and control act prevents the employment of unlawful aliens, but also protects prospective employees who want to restrict employers from delving into their 390 indiana health law review [vol. 5:371 employee retirement income security act and the health insurance portability and accountability act provide protections against employee discrimination, related particularly to the provision of healthcare benefits. a. employee retirement income security act of 1974 ("erisa") under section 510 of erisa, employers are expressly prohibited from disciplining or terminating an erisa employee benefit plan participant "for the purpose of interfering with the attainment of any right to which such participant may become entitled" under an erisa employee benefit plan.146 under this rule, an employer may not terminate a plan participant merely because the em­ ployee incurs higher healthcare costs, relative to other employees, under the employer's health insurance program.147 it is not clear, though, whether erisa protects prospective employees who engage in risky behaviors such as smok­ ing. 148 recent case law suggests that erisa section 510 does not protect job applicants. 149 b. health insurance portability and accountability act of 1996 ("hipaa") the preamble to hlp aa describes that the intent of the act is "to improve portability and continuity of health insurance coverage ... to combat waste, fraud, and abuse in health insurance and healthcare delivery, to promote the use of medical savings accounts, to improve access to long-term care services and coverage, to simplify the administration of health insurance, [etc. ]."150 hip aa added sections to both erisa and the public health service act that prohibit group health plans from discriminating against individual participants or bene­ ficiaries based on any health factor of such participants or beneficiaries. 151 backgrounds beyond what is necessary to comply with the law. id. (citing immigration reform andcontrolactofl986, 8 u.s.c. §§ 1324a(d)(2)(c), (0)(2000)). thefaircreditandreport­ ing act protects current and prospective employees' private lives by requiring employers to comply with notice provisions of the act. pagnattaro, supra note 125, at 670-71 (citing fair credit reporting act ofl996, 15 u.s.c. § 1681 (1993)). title vii protects employees' off-duty associational privacy. pagnattaro, supra note 125, at 671 (citing title vii of the civil rights act of 1964, 42 u.s.c. § 2000e (2003)). the employee polygraph protection act limits the use of polygraph tests to protect employees from employers who might abuse the test to seek infor­ mation beyond the scope of the employment responsibilities. pagnattaro, supra note 125, at 671 (citing employee polygraph protection act, 29 u.s.c. § 2002 (1999)). 146. steven j. friedman & lisa c. chagala, penalizing applicants and employees for smoking: a potential smoking gun?, employment & labor update, sept 2006, available at http:/ /www.lonnan.com/newsletters/article.php?article _id=506&newsletter _ id= 1 09&category _i d=l&topic=lb (citing employee retirement income security act, 29 u.s.c. § 1140 (2004)) (last visited mar. 14, 2008). 147. id. 148. id. 149. /d. 150. health insurance portability and accountability act of 1996, pub. l. no. 104-191, 110 stat. 1936 (codified in scattered sections of26, 29 and 42 u.s.c.). 151. nondiscrimination and wellness programs in health coverage in the group market, 2008] your money or your lifestyle! 391 under regulations released pursuant to hip aa, "health factors" include: health status, medical condition (including both physical and mental illness), claims experience, receipt ofhealthcare, medical history, genetic information, evidence of insurability, and disability.152 notably, the regulation's definition of .. evidence of insurability" incorporates participation in activities such as mo­ torcycling, snowmobiling, all-terrain vehicle riding, horseback riding, and ski­ ing153; thereby, prohibiting discrimination based upon beneficiaries' participation in such activities. "group health plans or issuers are not required to provide coverage for any particular benefit to any group of similarly situated individuals."154 benefits provided and any restrictions on benefits, however, must be applied uniformly to all similarly situated individuals; restrictions must not be directed at individual participants or beneficiaries based on any health factor of the participants or beneficiaries.155 generally, employers offering a group health plan may not require an in­ dividual, as a condition of enrollment or continued enrollment under the plan, to pay a premium or contribution that is greater than the premium or contribu­ tion for a similarly situated individual enrolled in the plan based on any health factor relating to the individual or a dependent of the individual. 156 an impor­ tant exception exists, however, to accommodate wellness programs.157 any program designed to promote health or prevent disease qualifies as a wellness program. 158 many employers encourage participation in wellness programs to drive down health costs by offering rewards to participants, such as reduced healthcare premium contributions. an estimated 30,000 plans covering 1.1 million participants vary employee premium contributions across similarly situ­ ated individuals due to participation in a wellness program that provides re­ wards based on satisfaction of a health factor-related standard. 159 research suggests that well-designed wellness programs can deliver benefits well in ex­ cess oftheir costs. 160 the u.s. centers for disease control and prevention es71 fed. reg. 75,014 (dec. 13, 2006) (to be codified 29 c.f.r. pt. 2590). 152. !d. at 75,038. 153. !d. 154. !d. at 75,014. 155. !d. at 75,014-015. 156. !d. at 75,041. 157. the interim rules and proposed regulations for hip aa referred to programs ofhealth promotion and disease prevention allowed under this exception as "bona fide wellness pro­ grams." !d. at 75,017. the final regulations have dispensed with the term "bona fide" with respect to wellness programs and, in its place have added a description ofwellness programs that do not have to satisfy additional requirements in order to comply with nondiscrimination requirements. !d. comments received from the release of the proposed regulations suggested that the use ofthe term "bona fide" fostered confusion because some programs that are not "bo­ na fide" within the narrow meaning of the proposed rules nonetheless satisfy the hip aa non­ discrimination requirements. /d. the final regulations treat all programs ofhea1th promotion or disease prevention as wellness programs and specify which of those wellness programs must satisfy additional standards to comply with the nondiscrimination requirements. !d. 158. !d. at 75,043. 159. !d. at 75,027. 160. !d. 392 indiana health law review [vol. 5:371 timate that implementation of a proven clinical smoking cessation program can save one year of life for each $2587 invested.161 a wellness program that does not make receipt of a reward conditioned on an individual satisfying a health factor-related standard does not violate hip aa regulations, so long as the program is available to all similarly situated indi­ viduals.162 a wellness program that conditions receipt of a reward on satisfac­ tion of a health factor-related standard is not in violation of hip aa regulations if the program satisfies five requirements: 163 (1) the reward for the wellness pro­ gram may not exceed twenty percent of the cost of coverage under the plan; 164 (2) the program must be reasonably designed to promote health or prevent dis­ ease;165 (3) the program must give eligible individuals the opportunity to qualify 161. !d. (citing j. cromwell et al., cost-effectiveness of the clinical practice recommen­ dations in the ahcpr guideline for smoking cessation, 278 jama 1759, 1759-66 (1997)). 162. id. at75,044. thefollowingexampleprogramswouldnotviolatethehipaaregulations: !d. !d. (i) a program that reimburses all or part of the cost for memberships in a fitness center; (ii) a diagnostic testing program that provides a reward for participation and does not base any part of the reward on outcomes; (iii) a program that encourages preventive care through the waiver of the copay­ ment or deductible requirement under a group health plan for the costs of, for example, prenatal care or well-baby visits; (iv) a program that reim­ burses employees for the costs of smoking cessation programs without re­ gard to whether the employee quits smoking; (v) a program that provides a reward to employees for attending a monthly health education seminar." 163. jd. 164. jd. specifically, the reward for the wellness program, coupled with the reward for other wellness programs with respect to the plan that require satisfaction of a standard related to a health factor, must not exceed twenty percent of the cost of employee-only coverage under the plan. however, if, in addition to employees, any class of dependents (such as spouses or spouses and de­ pendent children) may participate in the wellness program, the reward must not exceed twenty percent of the cost of the coverage in which an employee and any dependents are enrolled. . . . [t]he cost of coverage is determined based on the total amount of employer and employee contributions for the benefit package under which the employee is (or the employee and any de­ pendents are) receiving coverage. a reward can be in the form of a dis­ count or rebate of a premium or contribution, a waiver of all or part of a cost-sharing mechanism (such as deductibles, copayments, or coinsurance), the absence of a surcharge, or the value of a benefit that would otherwise not be provided under the plan. 165. id. the standard does not require scientific proof that the method used promotes wellness; the intent is to allow experimentation in diverse ways of promoting wellness. !d. at 75,018. this standard is met if the program has a reasonable chance of improving the health of or preventing disease in participating individuals, is not overly burdensome, and "is not a sub­ terfuge for discriminating based on a health factor, and is not highly suspect in the method cho­ sen to promote health or prevent disease." id. at 75,044. 2008] your money or your lifestyle! 393 for the reward at least once per year;166 (4) the reward must be available to all similarly situated individuals;167 and (5) the plan or issuer must disclose the availability of a reasonable alternative standard, or the possibility of waiver of the otherwise applicable standard.168 c. proposedfederallegislation some advocates argue that the time has come for new federal legislation to ensure appropriate levels of protection for the off-duty conduct of employees while balancing employers' legitimate interests. state statutes or constitutional amendments that recognize employee privacy rights but are framed in language requiring consistent court interpretation for enforcement provide inadequate protection for employees and leave uncertainties as to the scope of employee privacy rights. 169 in addition, the realities of a global economy and multistate employers make it difficult for employers to develop and implement employ­ ment practices that are compliant with the variable degrees of employee protec­ tion afforded by individual state statutes. 170 166. /d. in the earlier proposed hip aa rules, the requirement that a program give indi­ viduals the opportunity to qualify for the reward at least once per year was deemed indicative that the program was "reasonably designed to promote good health or prevent disease." /d. at 75,018. as proposed, the once per year requirement was intended to establish a bright-line standard for determining the minimum frequency that is consistent with a reasonably designed program. /d. a wide range of factors, however, could affect the reasonableness of the design of a wellness program. a program that imposes an overly burdensome time commitment or are­ quirement to engage in illegal behavior, for example, might not be reasonably designed. /d. 167. /d. at 75,044. a reward is not deemed to be available to all similarly situated indi­ viduals unless the program allows a reasonable alternative standard (or waiver of the otherwise applicable standard) for obtaining the reward: (1) for any individual for whom it is unreasonably difficult due to a medical condition to satisfy the otherwise applicable standard, and (2) for any individual for whom it is medically inadvisable to attempt to satisfy the otherwise applicable standard. /d. the specific alternative standard need not be established prior to commencement of the program; it is sufficient to determine a reasonable alternative standard once a participant gives notice of one ofthe qualifying conditions that prevents satisfaction of the otherwise appli­ cable standard. /d. at 75,019. employers are entitled to seek verification, such as a statement from an individual's physician that a health factor makes it unreasonably difficult or medically inadvisable for the individual to satisfy or attempt to satisfy the otherwise applicable standard. ld. at 75,044. 168. i d. all plan materials describing the terms ofthe program must disclose the availabil­ ity of an alternative standard. /d. however, if the plan materials provide only a general mention that a program is available, without detailing the terms of the program, this disclosure is waived. i d. the following sample language would satisfy this disclosure requirement: /d. if it is unreasonably difficult due to a medical condition for you to achieve the standards for the reward under this program, or if it is medically inad­ visable for you to attempt to achieve the standards for the reward under this program, call us at [insert telephone number] and we will work with you to develop another way to qualify for the reward. 169. rives, supra note 46, at 563-64 (citing pauline t. kim, privacy rights, public pol­ icy, and the employment relationship, 57 ohio st. l.j. 671, 709 (1996)). 170. /d. at 564 (citing laura b. pincus & clayton trotter, the disparity between public 394 indiana health law review [vol. 5:371 at the heart of any effective legislation must be a balancing of employees' rights against legitimate interests of employers. [employers should not] be forced to swallow all of the fmancial costs associated with their employees' off-duty lifestyle choices, such as higher life and health insurance premiums. if an employee chooses to engage in a high­ risk activity, such as smoking, it does not automatically follow that an employer should bear all of the additional financial costs associated with that choice. the division of costs between employer and employee, however, must be set out carefully; an employer should not be able to raise an employee's premiums so high as to make the supposedly protected off-duty activity cost prohibitive.171 the following statute, based in part on new york and north carolina statutes, has been proposed to balance employee rights and employer interests while fill­ ing gaps seen in some state statutes:172 1) unless otherwise provided by law, it shall be unlaw­ ful for any employer or employment agency to refuse to hire, employ or license, or to discharge from employ­ ment or otherwise discriminate against an individual in compensation, promotion or terms, conditions or privi­ leges of employment because of: a) an individual's political activities outside of working hours, off of the employer's premises, and without use of the employer's equipment or other property, if such activities are legal; b) an individual's legal use of consumable products prior to the beginning or after the conclusion of the em­ ployee's work hours, off of the employer's premises, and without use of the employer's equipment or other prop­ erty; c) an individual's legal recreational activities outside of work hours, off of the employer's premises, and without use of the employer's equipment or other property. these activities include but are not limited to: sports, games, hobbies, exercise, reading, and the viewing of television, movies, and similar material; d) an individual's membership in a union; or and private sector employee privacy protections: a call for legitimate privacy rights for private sector workers, 33 am. bus. l.j. 51,54-55 (1995)). 171. !d. 172. !d. 2008] your money or your lifestyle! e) an individual's personal relationships, romantic or otherwise, including those with fellow employees. 2) it is not a violation of this section for an employer to: a) restrict the lawful use of lawful products by em­ ployees during nonworking hours if the restriction re­ lates to a bona fide occupational requirement and is rea­ sonably related to the employment activities. if the restriction reasonably relates to only a particular em­ ployee or group of employees, then the restriction may only lawfully apply to them; b) restrict the lawful use of lawful products by em­ ployees during nonworking hours if the restriction re­ lates to the fundamental objectives of the organization; or c) discharge, discipline, or take any action against an employee because of the employee's failure to comply with the requirements of the employer's substance abuse prevention program or the recommendations of sub­ stance abuse prevention counselors employed or retained by the employer. 3) this section shall not prohibit an employer from of­ fering, imposing, or having in effect a health, disability, or life insurance policy distinguishing between employ­ ees for the type or price of coverage based on the use or nonuse of lawful products if: a) differential rates assessed by employees reflect actu­ arially justified differences in the provision of employee benefits; b) the employer provides written notice to employees setting forth the differential rates imposed by insurance carriers; and c) the employer contributes an equal amount to the in­ surance carrier on behalf of each employee of the em­ ployer.173 395 notably, section 1 of the proposed statute provides broad protection for em­ ployees, while identifying specific categories of rights to serve as guidelines for employers and employees. the reference in section 1 (b) to "consumable prod­ ucts" covers not only the typical alcohol and tobacco products, but also pro­ vides protection for employees against discrimination based on food consumption or its effects, such as obesity.174 but section 2(b) would allow 173. !d. at 564-65. 174. id. at 565-66. 396 indiana health law review [vol. 5:371 employers to restrict employees' consumption of those lawful products if the conduct interfered with the organization's fundamental objectives.175 while this would allow an organization with a fundamental objective of cancer pre­ vention to restrict smoking, the same would not be true of the weyco, inc. ex­ ample used earlier; weyco's objective is to administer healthcare plans, not prevent cancer.176 section three strikes to the heart of the employer strategy of making employees pay for their riskier behaviors or habits to reduce healthcare costs. the statute would not disallow distinctions between employees for their use of lawful products, but the employer would need to justify those distinc­ tions and make equal premium contributions for all employees. b. protection for employees' spouses and dependents the nature of the employer-employee relationship implies important du­ ties and rights between the two that provide a backdrop for protections afforded to the interests of employees. employees covered under an employer's health plan typically give a substantial amount of their waking hours to their responsi­ bilities as an employee. employers invest substantial resources into training and retaining quality workers. the protections that have been put in place for employees arose out of the give-and-take of the employment relationship. the nature of the relationship between the employer and the employees' dependents is not the same. voluntary participation in an employer's health plan may be the only legally significant connection between an employer and the employees' dependents. employers are not required to offer such health coverage, and the participation of employees' dependents is voluntary. while employers need not provide health coverage, once they do they are bound to keep their practices in compliance with existing protections for employees. hip aa provides protection to employees' dependents because they are benefi­ ciaries of an employer health plan. wellness programs provide a logical plat­ form by which employers could invade into information about beneficiaries' health habits. accordingly, hipaa's restrictions on the operation ofwellness programs and their relationship to incentives in health coverage provide some protection for employees and other beneficiaries, alike.177 effective protections for employees and their dependents do not come without an impetus for change. as with all change, civic will must coalesce in order to bring about changes in public policy. specific cases of invasions of privacy that bring the attention of the media and foster public debate can help bring about discussions, but often more is needed.178 to the degree that the labor market allows employers to be pickier about their hiring, employers could use off-work conduct as more of a factor in their hiring and firing of em175. id. at 566. 176. id. 177. see supra notes 151-164 and accompanying text. 178. sugarman, supra note 27, at 437. 2008] your money or your lifestyle! 397 ployees. 179 this, in turn, could draw more attention to employers' focus on what people are doing in their personal lives. loss of privacy in other areas could also prompt people to speak out about employer practices that infringe on the personal lives of employees and their dependents.180 reportedly, many in the human resources field sympathize with the importance of maintaining pri­ vacy; this could make employers who engage in lifestyle discrimination appear to be at odds with dominant social norms. 181 vii. alternatives for heal thcare cost containment employers and employees both have interests in containing the high cost of health insurance. the question is whether the existing framework of health­ care plans provides any alternatives that could contain costs while protecting against invasions of privacy rights. a. evolution of healthcare plans the traditional indemnity health insurance plans of the past have all but disappeared. 182 traditional indemnity health insurance permitted an individual to choose any healthcare provider, and the insurer would cover the majority (usually eighty percent) ofthe provider's fee, with the insured making up the difference out-of-pocket. 183 managed care has been the norm for some time and appears to have played a significant role during the 1990s in curtailing the rise in health insurance premium costs. 184 although managed care plans have been part of common vernacular since at least the late 1980s, a 2001 study found that while about ninety percent of workers who obtained health coverage through employment were enrolled in a managed care plan, about forty-seven percent of those actually enrolled in a managed care plan reported never being in one. 185 managed care organizations ("mcos") bring together the functions of care delivery and care reimbursement in an effort to control costs and health­ care utilization.186 through mcos, coverage is usually granted only for services rendered by a particular group or network of providers.187 reimbursement 179. !d. 180. id. 181. id. 182. henner, supra note 63, at 21 (citing employer health benefits2005, ann. survey (kaiser fam. found., menlo park, cal.), 2005 at 68, available at http://www.kff.org/ insur­ ance/7315/upload/7315 .pdf). 183. id. at 21-22. 184. jd. at 22. 185. !d. (citing managed care confusion, heal til confidence survey (emp. benefit res. lnst., washington, d.c.), oct. 2001, available at: http://www.ebri.org/pdf/surveyslhcs/ 200 1/mncr-fs.pdf). 186. jd. 187. id. 398 indiana health law review [vol. 5:371 for services provided is determined by a scheme devised by the mco and agreed to by the provider, with the intent to encourage cost-effective care.188 integrating care within a network is intended to accomplish two goals: (1) to provide high quality care while reducing incentives to "over-utilize medical services189; and (2) to maximize marketplace forces, such as volume and dis­ counting arrangement with providers and hospitals. 190 because of the perceived efforts ofmcos to interfere with physicians' methods of practicing medicine and their business practices, physicians lobbied fervently-and successfully for many decades-against the creation ofmcos at the state level.191 any substantial barriers to the development ofmcos were overcome, though, when federal government enacted legislation in 1973 to en­ courage the formation ofhealth maintenance organizations ("hmos").192 in response to growing healthcare costs, the legislation preempted state laws that discouraged or prohibited hmo formation. 193 several types of mcos exist: hmos, preferred provider organizations ("ppos"), and point of service ("pos") plans. 194 generally, hmos are organ­ ized as prepaid health care systems delivering health care exclusively through a network of healthcare providers in exchange for monthly premiums or other predetermined payments. 195 hmo subscribers typically choose a primary care physician who serves as a "gatekeeper" for additional services, such as referral to a specialist. 196 the specialist must be in the network for reimbursement; out­ of-network care is generally not covered. 197 additionally, any procedures or hospitalizations must receive preauthorization by the hmo to be eligible for reimbursement. 198 the second mco form is the ppo. ppos can be described as networks ofhealthcare providers who agree to reductions in their usual fee­ for-service rates in exchange for incentives insurers provide to patients to make use of in-network care.199 ppo subscribers receive discounted care, as long as they are seen by a physician within the network?00 unlike hmos, ppos usu­ ally do not require a primary care physician referral for specialist visits, but sub­ scribers may pay higher out-of-pocket expenses due to ppos' reliance on copayments and deductibles. 201 some consumers prefer the flexibility in physi188. /d. (citing day, supra note 67, at 7). 189. /d. (citing day, supra note 67, at 8). 190. /d. at 22-23. (citing day, supra note 67, at 8). 191. /d. at 23. 192. /d. (citing paul starr, social transformation of american medicine 290-334 (1982)). 193. /d. (citing day, supra note 67, at 21). 194. /d. at 24-6. 195. !d. at 24. 196. /d. 197. /d. 198. /d. 199. /d. at 25. 200. /d. 201. /d. 2008] your money or your lifestyle! 399 cian choice and healthcare utilization offered by ppos over hmos, despite the potential for higher out-of-pocket expenses.202 finally, pos plans function much like hmos.203 like in hmos, pos subscribers may see physicians with­ in the managed care provider network, but they may also exercise an option to receive out-of-network care.204 using a provider outside of the network, though, may come at the cost of significantly higher out-of-pocket expenses than the subscriber would have paid for in-network care.205 b. alternative cost-cutting strategies in the wake of criticism for a number of their cost control measures, mcos have embraced several different strategies intended to help reduce costs for employers while keeping their own profits at a healthy level.206 one com­ mentator has identified three such strategies being utilized by mcos: (1) loos­ ening their control over health coverage decisions; (2) creating different levels of coverage (e.g., an enrollee pays less for in-network care and more for out-of­ network care); and (3) offering "consumer-driven health plans," in which em­ ployees are given greater choice in choosing a health plan and assume more financial responsibility (e.g., choosing a high-deductible plan in conjunction with a health savings account option).207 the third strategy, in particular, seems likely to become widespread.208 with the renewed rapid inflation of health insurance costs, the federal government ... has sought new meth­ ods of cost containment, largely in the form of "con­ sumer directed" healthcare. the drafters of recent legislation and rules in this regard appear to have largely subscribed to the theory that, by reducing "moral haz­ ard" in health insurance, we can help reduce healthcare costs. "moral hazard" in the sphere of health insurance refers to the theory that those who are insured tend to in­ cur greater costs with respect to it, due to the very fact that they do not have to pay for those costs out of pocket, or are only responsible for a fraction of them. propo­ nents of consumer directed healthcare therefore assume that, if individuals are made to be more responsible for 202. id. at 25-26 (citing day, supra note 67, at 22-3). 203. id. at 26. 204. id. 205. id. 206. !d. at 40. 207. !d. (citing john v. jacobi, after managed care: gray boxes, tiers and consumer­ ism, 47 st. louis u. l. j. 397, 401-06 (2003)). 208. id. at 4l. 400 indiana health law review the costs of the health care they consume, they will make more prudent choices with respect to it. 209 [vol. 5:371 the strategies being used by mcos may hold potential for impacting healthcare costs for employers, but it is less clear how cost savings would be realized by employees. one expert suggests the employer-based health insur­ ance system is more fundamentally flawed and calls for an economic response to revamp competition among healthcare delivery systems.21° certainly, the potential benefits of plans for universal health coverage have been much de­ bated in political discourse. 211 any plan for cutting healthcare costs must, how­ ever, address a reality of primary importance: [p]atients of all incomes need timely and competent medical attention from both generalists and specialists without having to withstand bureaucratic battles at the same time as they are coping with illness or injury. they need to be able to expect their plan to deal with them in good faith concerning the benefits that their pol­ icies say they are supposed to receive. they also need timely and competent primary care.212 in short, patients must be able to rely on the quality and timeliness of the medi­ cal care provided by their insurance plans. viii. conclusion health insurance costs generally have been on the rise for the last several decades.213 cost escalation is not a new phenomenon. whether by design, or historical accident, employment and access to the healthcare system have be­ come intrinsically linked in the united states. as a result, employers do much more than facilitate industry and provide a forum for workers to establish voca­ tions and earn wages. employers represent the gateway through which count­ less employees and their families access vital healthcare services. for some time, employers have contained costs associated with providing health insurance for employees by avoiding or limiting those costs through se­ lective hiring and shifting costs to employees who engage in unhealthy behav209. !d. 210. see alain c. enthoven,employment-basedhealth insurance is failing: now what?, w3 health aff., web excwsive 237 (may28, 2003), available at: http://content.healthaffairs. org/cgi/reprintlhlthaff. w3 .23 7v 1 ?maxtoshow=&hits= i o&hits= 1 o&resul tformat=&auth or 1 =enthoven&andorexactfulltext=and&searchid= 1 &firstindex =o&resourcetype=hwcit (last visited mar. 14, 2008). 211. see hermer, supra note 63, at 57-82. 212. !d. at 53. 213. id. at 13-16. 2008] your money or your lifestyle! 401 iors. now, employers are looking to realize savings by shifting costs to em­ ployees' dependents that practice unhealthy or risky behaviors. as equal bene­ ficiaries, employees and dependents have the same contractual rights with respect to the employer's health insurance plan. employer practices that restrict or pry into the personal lives of employees and their dependents raise legitimate concern of infringement of privacy rights. in response, limited employee pro­ tections have been put in place at the state and federal levels. the reality is that the employment relationship is unique, different from, and more substantial than the relationship between the employer and the em­ ployees' dependents. until a clarion alarm is raised against employer invasions of the privacy of employees' dependents, the requisite civic will is not likely to be raised to bring about changes in public policy to provide specific protections for this class of beneficiaries. employers, employees, and their dependents all have a vested interest in finding solutions to the problem of making health insurance affordable. alter­ natives that generate savings by simply shifting costs from one side of the equa­ tion to the other are not generating true savings. at the same time, onus must be placed on individuals who knowingly engage in risky or unhealthy behav­ iors; those who take the risks must understand that higher healthcare costs may be a consequence of their actions. fundamental changes to the healthcare sys­ tem, such as efforts to give healthcare consumers more choice-and more re­ sponsibility--or the implementation of universal healthcare coverage could significantly change the nature of employment-based health insurance. in the end, in balancing all of these factors, the critical judgment may boil down to what we place more value on as a society: lower cost healthcare or fewer re­ strictions on personal freedoms. review and evaluation of indiana's inspect system and governing legislation: maximizing potential impact on public health, a a review and evaluation of indiana's inspect system and governing legislation: maximizing potential impact on public health jacob o'brien* i. introduction.................................... 702 ii background .................................... 704 a. the prescription drug problem ................ 704 1. national data .............................. 704 2. indiana data ....................... 708 b. combating the problem.................. ..... 709 1. differences in state programs... ......... 711 2. additional problems in establishing and developing pmps .................. ..... 713 3. attitudes concerning the effectiveness of pmps..................... ........... 714 c. indiana's inspect system ...................... 715 1. coverage ......................... ..... 715 2. authorized users........................716 3. access and accuracy of information... ..... 717 4. responsibilities and liability issues.... .... 718 iii. analysis ............................... .... 719 a. evaluating the inspect system .............. 719 1. detecting and preventing abuse and misuse ... 720 2. promoting proper use.............. ..... 721 3. informing the public ................ ..... 722 4. evaluation of impact................ ..... 723 5. overall ........................... ..... 723 b. evaluation of indiana pmp laws .............. 724 1. some positive aspects........................724 2. some shortcomings in the law ............ 725 c. recommendations for change .......... ....... 727 1. continue to increase number of interoperability agreements ..................... ...... 728 2. develop a more proactive system ........... 729 3. create an independent evaluative entity........730 * j.d. candidate, 2013 indiana university robert h. mckinney school of law; b.s., 2009 indiana university. indiana health law review 4. allow for monitoring non-scheduled substances ......... 731 5. require practitioners to consult the inspect database ......................... ..... 733 d. cost effectiveness ........................... 737 iv. conclusion ....................................... 739 i. introduction over the last couple of decades, the number of americans injured or killed as a result of abuse and misuse of drugs has increased at an alarming rate.' the largest source of this increase has come not from the use of illicit drugs, but, instead, from the abuse and misuse of prescription drugs.2 the vast array of drugs, developed with an intent toward treating the innumerable ailments from which people suffer, appears to have become something of an ailment itself, and the supply of prescription drugs is now as great as it has ever been. 3 in just a relatively short time, prescription drug abuse and misuse has become one of the most pervasive problems facing health care systems across the country. 4 in fact, 1 quickstats, 59 morbidity & mortality wkly. rep. 1009, 1026 (2010), available at http://www.cdc.gov/mmwr/pdf/wk/mm5932.pdf ("from 1999 to 2007, the number of u.s. poisoning deaths involving any opioid analgesic . . . more than tripled," reaching 36% of all poisoning deaths in 2007.). 2 see, e.g., prescription painkiller overdoses in the us, vital signs (cdc, atlanta, ga.), nov. 2011, at 1, 2, available at http://www.cdc.gov/vitalsigns/pdf/2011-11-vitalsigns.pdf (stating that "overdose deaths from prescription painkillers have skyrocketed" in recent years, and overdoses from the use of such drugs are now a "public health epidemic"). 3 id. 4 see, e.g., lisa girion et al., drugs now deadlier than autos; fueled by highly addictive prescription pain medications, fatal overdoses have surpassed traffic deaths nationwide, l.a. times, sept. 18, 2011, at al (noting that the liberalized prescribing of pain drugs that began more than a decade ago may be the cause of the current epidemic). 702 vol. 10:2 indiana's inspect system statistics now show that prescription pain and anxiety drugs are responsible for more deaths than heroin and cocaine combined.5 unsurprisingly, the states have responded. forty-nine of the fifty states now have legislation in place allowing for the collection and supervision of prescription drug related data, with forty-two of those states having functional prescription drug monitoring programs.6 these prescription monitoring programs (pmps) are seen as "highly effective tools utilized by government officials for reducing prescription drug abuse and diversion."7 recognizing the gravity of this issue and the impact felt in its own state, the indiana legislature created a body of law requiring the collection of controlled substance data in the mid-1990's, which led to the development of the inspect system in its current form in 2004.8 although these efforts certainly reflect a movement in the right direction, injuries and deaths due to prescription drugs have continued to rise among indiana citizens.9 while the inspect system certainly appears to be a useful resource in combating the prescription drug problem in indiana, it may be the case that certain aspects of the system itself, and of its governing legislation, are limiting its ability to reach its full potential in this regard. in fact, under the current statutory scheme, there may actually be an incentive for non-dispensing practitioners to simply avoid using the inspect system at all. this paper is aimed at analyzing such shortcomings and exploring the feasibility of addressing them. the ultimate goal of this evaluation is to 5 id. 6 alliance of states with prescription monitoring programs, prescription monitoring frequently asked questions (faq) 1 (2012) [hereinafter prescription monitoring faq], available at http://www.pmpalliance.org/pdf/pmp%20faq%202012/ 20%20finalforprint.pdf. 7 id. 8 see generally ind. code § 35-48-7 (2012). 9 see, e.g., cdc, policy impact: prescription painkiller overdoses (2011), available at http://www.cdc.gov/homeand recreationalsafety/pdf/policylmpact-prescriptionpainkillerod.pdf (depicting death rates due to prescription drugs across the u.s.). 2013 703 indiana health law review promote more widespread use of the inspect system and to maximize the utility of the program. ii. background a. the prescription drug problem 1. national data in recent years, the united states has seen the number of deaths from most major preventable causes of death steadily decline.10 perhaps the biggest and most worrisome exception to this trend has been the category of drug-related deaths. in march of 2011, preliminary data collected by the u.s. center for disease control and prevention showed that at least 37,485 deaths were related to drugs in 2009.11 this number is not only significant because of the sheer number of deaths, but also because it is greater than that of traffic related fatalities12 for the first time since data on drugrelated deaths began to be tracked.13 the preliminary data for 2010 indicated a continued increase in drug-related deaths, and once again the numbers were greater than those related to motor vehicle accidents.14 as mentioned above, the biggest source of what is now being referred to as an epidemic of drug-related injuries and deaths has come from the abuse and misuse of prescription 10 girion, supra note 4. 11 kenneth d. kochanek, deaths: preliminary data for 2009, nat'l vital statistics reps., mar. 16, 2011, at 20, available at http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_04.pdf. 12 id. at 19 (reporting deaths at 36, 284). 13 girion, supra note 4. 14 sherry l. murphy, deaths: preliminary data for 2010, nat'l vital statistics reps., jan. 11, 2012, at 19-20, available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr6oo4.pdf (reporting drug-related deaths at 37,792 and deaths from motor vehicle accidents at 35,080 and explaining that, while the drug-induced death rate declined from 2009 based on preliminary numbers, the actual number of such deaths may be substantially higher because of the delay in obtaining conclusive information about this particular cause of death). 704 vol. 10:2 indiana's inspect system drugs, particularly in the form of prescription painkillers..15 in 2008, the number of deaths resulting from prescription painkiller overdoses alone had more than tripled in the years since 1999.16 in 2009, around 50,000 emergency room visits were related to prescription painkiller use, and the rate of admission to substance abuse treatment programs was nearly five times that in 1999.17 such a surge in this misuse and abuse has led to health insurance providers now spending around $72.5 billion annually on the associated costs.18 if the trend continues to move as it has in recent history, this already staggering amount seems poised to continue to grow at an increasing rate. particularly troubling is the threat that prescription drugs pose to young people. there is data suggesting that teens abuse prescription drugs more than any illegal drug, with the only exception being marijuana. 19 in 2008, more 15 leonard j. paulozzi et al., vital signs: overdoses of prescription opioid pain relievers united states, 1999-2008, early release, morbidity & mortality wkly. rep., nov. 1, 2011, at 1, available at http://www.cdc.gov/mmwr/pdf/wk/mm60e1101.pdf. 16 id. at 5 (demonstrating overdose deaths from opioid pain relievers from 1999-2010). 17 id. from 1999-2008, the death rate from overdoses and the admission rate to substance abuse programs "increased in parallel." id. at 3. additionally, sales of opioid pain relievers in 2010 were four times greater than sales in 1999. id. the statistics clearly demonstrate that although the number of people abusing these drugs has continued to increase significantly, these drugs are as readily available as ever. 18 id. at 6; see also join together, prescription drug abuse leads to higher health care premiums, fraud group says, the partnership at drugfree.org (feb. 27, 2012), http://www.drugfree.org/jointogether/prescription-drugs/prescription-drug-abuse-leads-to-higherhealth-care-premiums-fraud-group-says [hereinafter drugfree.org (explaining that "[m]ost of the cost comes from treatment, in the form of visits to the emergency room, rehabilitation, and associated health problems" and that a single person engaged in "doctor shopping" costs insurers between $10,000 and $15,000). when one considers that amount of people that are abusing these drugs, there is an almost undeniable implication that many of these people have engaged in "doctor shopping" in some way, and the costs that they impose on insurers is enormous. 19 model prescription monitoring program act § 2(d) (nat'l alliance for model state drug laws, 2011) [hereinafter model pmp], available at http://www.namsdl.org/documents/modelpmpact111911 2013 705 indiana health law review than 2.1 million teens aged 12 to 17 reported abusing prescription drugs.20 unlike illegal drugs, young people need not even actively seek such prescription substances out for themselves. in 2010, the largest pharmacy-benefit manager in the u.s., medco health solutions inc., claimed that more than 25 percent of kids and teens take a medication on a chronic basis and almost seven percent of them are taking two or more drugs. 21 additionally troubling is the fact that many of the drugs being taken by these young people are drugs that have been considered appropriate for use only by adults in the past.22 when compounded with the fact that data exists suggesting that "90 percent of prescription drugs addictions start in teenage years," the recent trend becomes particularly alarming.23 considering the amount of resources that the u.s. has spent on efforts to keep drugs out of the hands of children, the fact that such a significant portion of this country's youth has many drugs readily accessible to it is particularly discouraging. children and teens no longer need to seek out a drug dealer, or even raid their parents' medicine cabinet. to gain access to many drugs, young people need only open their own medicine cabinets, or alternatively, simply ask withoutcommentary_001.pdf. a number of other, more general findings are also quite significant. for example, the number of people abusing prescription drugs exceeds the sum total of all people who use cocaine, heroin, hallucinogens, ecstasy, and/or inhalants. id. at § 2(b). the act also finds "little indication that the death toll [from abuse of such drugs] is abating." id. 20 id. (adding that, in 2006, this age group also accounted for onethird of all new prescription drug abusers). 21 anna w. mathews, so young and so many pills, wall st. j., dec. 28, 2010, at dl, available at http//online.wj.com/article' sb10001424052970203731004576046073896475588.html?mod=wsj hppeditorapicks 1 (last visited may 26, 2013) (attributing the increase in prescription drug use among young people to both increased awareness of drugs as an option for kids and a general lack of healthy dietary habits and exercise among young people). 22 id. (identifying statins, diabetes pills, and sleep drugs as examples). 23 legally dead: exploring the epidemic of prescription drug abuse, rehabs.com, (last visited february 19, 2013), http://www. rehabs.com/explore/prescription-drug-abuse-statistics/. 706 vol. 10:2 indiana's inspect system the one in four of their peers with such access to open theirs. adding to the complexity of the prescription drug problem is the propensity for many prescription drugs to interact dangerously with other substances. 24 this includes other types of legal drugs, whether they are over-thecounter or require a prescription. when one considers the number of prescriptions being written in the u.s., the enormous scope of this problem comes into focus. in 2007, the institute for safe medication practices issued a report claiming that two of every three patients that seek out a doctor for care receive at least one prescription as a result.25 with the continued discovery and development of new drugs for a growing number of recognized and treatable ailments, it is likely that this ratio has increased in the years since that report. in addition, the u.s. food and drug administration has stated that the likelihood of an adverse, potentially dangerous drug interaction increases drastically when a patient is taking more than three medications at once. 26 when this is coupled with the fact that around forty percent of the u.s. population has four or more prescriptions, there is an almost undeniable implication that dangerous drug interactions contribute significantly to the prescription drug epidemic in this country.27 24 avoiding drug interactions, archive of consumer updates, fda, http://www.fda.gov/forconsumers/consumerupdates/ucm096386. htm (last visited may 17, 2013). in addition to potentially interacting with different types of drugs, many prescriptions also have the potential to interact adversely with many types of supplements, foods, and drinks. id. 25 id. 26 id. although many drugs are now known to interact adverse-ly when taken together, most of these drugs are not withdrawn from the market. in fact, "market withdrawal of a drug is a fairly drastic measure" and "[m]ore often, fda will issue an alert warning the public and health care providers about risks as the result of drug interactions." id. this makes keeping track of prescription information all the more important. 27 id. 2013 707 indiana health law review 2. indiana data indiana has been no exception to the national prescription drug trend. in november of 2011, the cdc published a report illustrating that 13.2 of every 100,000 hoosiers died from some type of drug overdose in 2008.28 unsurprisingly, the data suggests that as the sales of these drugs increase in indiana, so too does the number of people abusing or misusing them, which in turn increases the incidents of injury and death. 29 as with the national trend, a majority of these deaths and injuries were related to prescription drug use, with opioid painkillers being the largest contributor. 30 but painkillers are not the only prescription drugs being abused. for example, adderall appears to be a drug that is abused and misused with significant frequency, particularly among college students. 31 it is likely that these numbers only begin to reflect the true scope of the problem these institutions face, as only a small sample of students participated in the survey. nevertheless, they demonstrate the continued emergence of prescription drug use in different settings. with respect to cases of innocent or accidental misuse of drugs specific to indiana, there is a very limited amount of data available. this may be due to issues related to the way this type of data is collected. many such incidents are simply classified generally as an overdose, and are not necessarily reported, statistically speaking, with reference to the drug that caused the overdose. what the data that is 28 paulozzi et al., supra note 15, at 4. 29 see id. 30 id. at 1; see also legally dead, rehabs.com, http://www. rehabs.com/explore/prescription-drug-abuse-statistics/ (last visited may 17, 2013) (stating that pain relievers are the cause of or a contributing factor to almost 3 out of 4 prescription drug overdoses). 31 rosemary king & mi kyung jun, indiana collegiate action network, results of the indiana college substance use survey 11 (2011), available at http://www.drugs.indiana.edulpublications/ icsus/icsussurvey_2011.pdf. it is important to note, however, that only 12.6% of students invited to participate in the survey responded. id. at 4. clearly the results of this study are limited, and it is probable that the data collected only reflects the tip of the proverbial iceberg. 708 vol. 10:2 indiana's inspect system available suggests is that when compared to the age adjusted death rate of prescription drug injuries and deaths in other states, indiana is close to the middle of the pack. 32 considering the seriousness and pervasiveness of the prescription drug issue, as illustrated in the discussion above, the problem in indiana is clearly not under control; the indiana legislature and health care practitioners must strive for improvement with regard to these numbers. b. combating the problem in an effort to bring the explosion of the prescription drug problem back under control, the states began developing prescription drug monitoring programs (pmps) as early as 1939 in california. 33 as mentioned above, fortynine of the fifty states now have legislation allowing for the collection of prescription data, and forty-two actually have functional pmps. 34 these programs generally collect data about prescriptions that involve federally controlled substances, and have the general purpose of assisting authorized pmp users in identifying problematic prescriptions in the hopes of deterring and reducing the abuse and misuse of drugs covered by the respective system.35 32 see paulozzi et al., supra note 15 (including data showing that the indiana overdose death rate is about 13.2 per 100,000, which exceeds the national rate of 11.9 per 100,000 by a considerable margin and clearly suggests that further efforts toward combating prescription drug abuse in the state of indiana are warranted). 3 karen blumenschein et al., review of prescription drug monitoring programs in the united states 2 (2010), available at http://chfs.ky.gov/nr/rdonlyres/85989824-1030-4aa6-91e1-7f9e3ef68827/ 0/kasperevaluationpdmpstatusfinalreport6242010.pdf. see also aarron m. gilson et al., time series analysis of california's prescription monitoring program: impact on prescribing and multiple provider episodes, 13 j. of pain 103 (2012), available at http://www. painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/gilson 2012_a% 20time%20series.pdf (describing the characteristics and framework of the earliest monitoring program developed in california). 34 prescription monitoring faq, supra note 6. 35 blumenschein et al., supra note 33. 7092013 indiana health law review one significant goal of these programs is to prevent individuals from obtaining an amount of a given drug that exceeds their actual need through the use of "doctor shopping".36 "doctor shopping" describes a situation in which an individual seeks out multiple prescription providers and dispensers in order to procure as much of a particular drug as possible. this can also allow an individual to obtain prohibited combinations of drugs that may create significant health risks if taken simultaneously. to aid in preventing this phenomenon, many states allow law enforcement to access their pmps in relation to drug investigations. 3 7 additionally, many pmps share prescription data across state lines, further assisting in the detection of doctor shopping. 38 the above information clearly illustrates that the overarching purposes of the pmps in the states that have them are substantially the same. as one would expect, these programs share some essential aspects in attempting to achieve their objectives. however, in spite of these general similarities, there is significant variation in secondary goals and additional means of achieving them across the states. understanding these differences is an important step in attempting to improve upon the effectiveness of any state pmp, especially as many states become increasingly willing 36 id.; see also drugfee.org, supra note 18 (providing a loose definition of the term and discussing the costs that individuals engaging in such activity impose on society). 37 blumenschein et al., supra note 33 (explaining that this allows law enforcement to "more efficiently collect and analyze data that may be useful in identifying those individuals involved in trafficking or misuse of prescription drugs"). 38 see, e.g., nabp pmp interconnect celebrates one year of connecting prescrnption monitoring programs to combat prescription drug abuse, nabp.net, (aug. 16, 2012, 12:34 pm), http://www.nabp. net/news/nabp-pmp-interconnect-celebrates-one-year-of-connectingprescription-monitoring-programs-to-combat-prescriptiondrug-abuse [hereinafter nabp.net (describing not only the general aspects of the program, but also some details into how the program deals with the "unique access and usage requirements" of the various state programs). it is noteworthy that nabp covers all costs associated with developing and operating the program without government funding. id. 710 vol. 10:2 indiana's inspect system and able to share prescription information across state lines. 1. differences in state programs although the fact that the vast majority of states have established pmps is of considerable importance in combating the prescription drug problem, the existence of numerous systems has created problems of its own. each state is charged with the choice of whether and by what means to establish a monitoring program, and not all states take the same approach. 39 considering the doctor shopping efforts of many individuals discussed above, this can become problematic when such individuals cross state lines to obtain drugs. in an attempt to reduce these differences and provide for more uniform programs, the national alliance for model state drug laws (namsdl) developed a model that sets forth the key characteristics of a strong pmp. 4 0 additionally, a growing number of states are making efforts to achieve agreements of "interoperability" between their respective program and the programs of other states, which allow for the sharing of prescription drug data across state lines. 41 despite these efforts, the differences between the programs across the states and their respective pmp laws remain an obstacle in the ability of the states to prevent interstate doctor shopping. existing state pmps differ in a number of respects. for one, many states' programs are run by their respective boards of pharmacy, but some are run by other entities, such as professional state licensing boards or law 39 see generally blumenschein et al., supra note 33, at 6-7 (noting information reflecting some differences in state programs in table 1: prescription drug monitoring program characteristics by state). 40 see generally model laws, national alliance for model state drug laws, http://www.namsdl.org/modellaws.htm (last visited may 17, 2013) (stating that links allow the suggested prescription drug laws pertaining to various issues to be viewed accordingly). 41 see generally blumenschein et al., supra note 33, at 6-7; see also nabp.net, supra note 38. 2013 711 indiana health law review enforcement agencies. 42 these differences may reflect the varying goals of the states, with some appearing to take a punitive approach, and others a more preventative approach. another common difference among pmps can be found in which schedules of controlled substances the programs cover. 43 some states even go so far as to allow for the collection of certain non-scheduled substance data in certain instances.44 additionally, states differ in which groups are allowed to access pmp information.45 for example, a state's pmp laws may allow personnel of certain licensing boards to access the information within their monitoring program, while other states may choose to exclude them.46 the same is true with respect to law enforcement officials. 47 states also differ in how they approach the production of program reports for authorized users, but most programs produce the informational reports on a reactive basis,48 although there is probably a widespread desire for more proactive systems. another crucial difference in state pmps is in the approach to liability issues. some states effectively bar any prescriber or dispenser from liability with regard to referencing prescription data.49 in some instances, this even means 42 blumenschein et al., supra note 33, at 6-7 (demonstrating that, although there are clearly some exceptions, most programs are overseen by the respective state's board of pharmacy). 43 id. 44 id. at 8 (see figure 3). but, in some states, additional regulations may be necessary prior to initiating actual monitoring of non-controlled substances. id at 7. 45 id. at 13-20 (organizing the various approaches states have taken with respect to groups authorized to access pmp information and demonstrating that, while there is significant overlap, distinctions can clearly be made between states). 46 id. 47 id. 48 id. at 20. note that, at the time the report cited was issued, a number of states did not have programs that were at an advanced enough stage to have proactive reports. 49 id. at 9; see also, e.g., ind. code § 35-48-7-11.1 (2012) (currently, indiana does not require non-dispensing practitioners to reference pmp data. however, there was a bill being considered during the drafting of this note that may change this. this is discussed in greater detail below.) 712 vol. 10:2 indiana's inspect system that there is no requirement that such practitioners even reference the program's prescription information at all before issuing a prescription. 5 1 2. additional problems in establishing and developing pmps beyond the differences in pmps and their governing legislation, there are a number of other issues that the states must address in forming their respective programs. one such issue lies in the desire to create a program that produces the most current and reliable prescription data reports possible. many states have expressed a need to develop such a real time program in which data is entered directly into the system and is available for reference immediately, but as of yet, not one state has succeeded in this regard.51 another obvious issue is that of maintaining confidentiality. because these programs collect personal health information of a given individual, significant measures must be taken to ensure that the privacy of such information is protected. these measures can contribute significantly to the complexity in operating the program, as well as the associated costs. 5 2 further problems are sourced in the fact that not everyone agrees that pmps are worth the trouble when it comes to combating prescription drug abuse. many opponents of pmps have expressed concern that such programs lead to prescribers becoming less willing to make prescriptions for drugs covered by the program. 53 this, they 50 id. at 9-10. although non-dispensing practitioners are not currently required to access pmp data in indiana, dispensing practitioners are required to refer to this information, as will be discussed in greater detail below. 51 id. at 13-20 (showing that, currently, even the fastest pro-grams' information may have a lag time of several days to a week). 52 see generally id. at 10-12 (mentioning many factors, all of which can complicate the issue of states making sure that the information contained in their pmp databases remains secure). 53 pilar kraman, drug abuse in america prescription drug diversion, council of state gov'ts 12 (2004), available at http://www.csg.org/knowledgecenter/docs/tao404drugdiversion.pdf 2013 713 indiana health law review argue, has an adverse effect on the overall quality of patient care because some may not receive all, or any, of the drugs that they need.54 such concerns may provide some explanation as to why some states bar liability on practitioners for failure to utilize pmp data. although this argument appears to make logical sense, the fact is that the data being collected regarding the amount of prescriptions given and the number of people consuming them seems to indicate that this "chilling effect" is more of a theory than a reality.55 nevertheless, it is something that certainly must be considered in forming pmps and their respective laws, as overall quality of care should not be threatened or harmed in this process. prescribers must be informed about the purposes of the programs and how to view them as a tool rather than an obstacle to administering care. 3. attitudes concerning the effectiveness of pmps despite the fact that only a few states have conducted an evaluation on the impact of their respective programs in any official manner, the general attitude among states with operating pmps is that the programs have had a positive impact in hindering the ability of individuals to abuse and misuse prescription drugs. 56 for the states that have officially evaluated their programs, the finding has been that doctor shopping has become more identifiable, and thus preventable, thanks to these programs.57 however, in spite (while "[slome reports have suggested that states with pdmps have seen 35 to 50 percent reductions in the prescribing of regulated controlled substances, . . . the overall production of schedules ii and iii narcotics has steadily increased" in recent years.). 54 id. although the argument is certainly worthy of consideration, the continued increase in production and consumption of scheduled substances certainly weighs heavily in favor of continuing to track such information through pmps. as the article suggests, the best remedy for this "chilling effect" is probably education of practitioners, as well as patients. id. 55 id.; see also, e.g., paulozzi, supra note 15. 56 blumenschein et al., supra note 33, at 20. 57 id. at 20-23 (reporting that valuations of the pmps in maine, virginia, and kentucky all indicated the presence and use of the 714 vol. 10:2 indiana's inspect system of this positive response, the fact remains that consumption of controlled drugs has continued to rise, and with it, the number of injuries and deaths from such consumption.58 while this certainly helps to counter the argument of opponents regarding the chilling effects of pmps, it also indicates that perhaps more must be done in states seeking to maximize the impact of these programs. c i2diana ' inspect system the indiana scheduled prescription electronic collection and tracking (inspect) program was created in its current form in 2004 as a means of collecting prescription drug information in accordance with indiana legislation passed in the mid 1990's regarding such data. 59 the expressed goals of the indiana legislature in the operation of the system are to provide patient information storage for health care professionals and provide a resource for controlled substance investigations of law enforcement.60 in addition, the legislature has clearly expressed that in no way is inspect meant to limit doctors in their treatment methods, nor is it meant to compromise privacy rights of indiana citizens in any way.61 1. coverage in 2005, the scope of inspect was expanded from covering only schedule ii substances to covering data on schedules ii, iii, iv, and v.62 indiana is not currently among the states that have provided statutory authority for the collection of non-scheduled substances under any respective state program helped at least to some considerable degree to combat doctor shopping). 58 paulozzi, supra note 15. 59 about inspect in.gov, http://www.in.gov/pla/inspect/ (last visited may 20, 2013); see also ind. code § 25-1-13 (2013). 60 about inspect supra note 59 (adding that considerable measures are taken to "prevent abuse and ensure the confidentiality of patient medical records and other privileged information."). 61 id. 62 see ind. code §§ 35-48-7-2.5 to -10 (2012). 2013 715 indiana health law review circumstances. 6 3 when a substance covered by the inspect system is distributed to a patient, the dispenser must submit certain information pertaining to the transaction into the inspect system, including the name of the individual, the identity of the substance being distributed, and the quantity and number of days supply the individual is receiving. 64 this monitoring is intended to provide authorized viewers with the necessary information to identify situations of potential abuse or misuse of monitored substances. 2. authorized users the operation of the inpsect system is overseen by the indiana board of pharmacy. 65 additionally, there are a number of other groups authorized to access the system's prescription data.66 some groups authorized to access the prescription information include law enforcement, state toxicologists, and certified medicaid representatives. 6 7 with respect to prescribers and dispensers, the law authorizes a "practitioner or practitioner's agent" to access prescription data. 68 included within the definition of "practitioner" are physicians, pharmacists, hospitals, and several other categories of healthcare related individuals. 69 additionally, indiana law allows for inspect data to be shared with pmps of other states with which an agreement of interoperability has been reached. 70 indiana has been among the leading states with respect to interstate sharing of prescription data since it began sharing such information with ohio in 2011.71 now, indiana is sharing its inspect data with numerous other states. as a member of the 63 see id.; see also blumenschein et al., supra note 33, at 8. 64 ind. code § 35-48-7-8.1 (2012). 65 ind. code §§ 35-48-7-8.1, 12.1 (2012); see also ind. code § 3548-1-6 (2012) (defining "board"). 66 see ind. code § 35-48-7-11.1 (2012). 67 id.; see also blumenschein et al., supra note 33, at 14-15. 68 ind. code § 35-48-7-11.1(d)(4) (2012) 69 ind. code § 35-48-7-5.8 (2012). 70 ind. code § 35-48-7-11.1(d)(5) (2012). 71 about inspect supra note 59 (click "inspect at-a-glance"). 716 vol. 10:2 indiana's inspect system national association of boards of pharmacy's (nabp) interconnect program, indiana can now share prescription data with all of the following states: arizona, connecticut, kansas, michigan, north dakota, ohio, south carolina, and virginia. 72 the presence of a growing number of state pmps will place pressure on doctor-shoppers to cross state lines in order to procure their desired drugs, and forming more agreements of interoperability will become crucial in deterring such efforts. although it may seem obvious that individuals should be authorized to access their own inspect report, the legislation regarding authorized users does not directly address this issue. a fairly recent indiana court of appeals decision resolved this, holding that individuals may request access to their personal inspect reports in certain situations. 73 the court in that case basically seemed to say that unless there is a compelling reason for denying an individual access to such information, such access must be allowed.74 3. access and accuracy of information authorized users access the data contained in the inspect system by simply signing into the online database and looking up the name of the individual. information on the patient is then available for viewing immediately, with the only constraint being that there may be up to a seven day lag period for the input of new data.75 this input of new data is communicated to the inspect system by an authorized user simply uploading the data 72 nabp.net, supra note 38 (adding that several other states have indicated an intent to join nabp interconnect, which would bring the total to 22 states sharing data). 73 williams v. state, 959 n.e.2d 360, 367 (ind. ct. app. 2012). 74 id. at 368-369 ("where, as here, a patient seeks to waive those privileges for the purpose of exercising his or her constitutional right to present a complete defense to charges in a criminal case, both the rationale for and the board's interest in keeping the patient's prescription records confidential evaporate."). 75 blumenschein et al., supra note 33, at 14-15. 7172013 indiana health law review onto the database on-line. 76 implicit in the aforementioned information is that inspect only provides a prescription report to an authorized user upon request, making it a reactive system as opposed to a proactive one. although developing a more proactive system is probably desirable, the inspect system is relatively up-to-date and easily accessible. while there are certainly aspects of inspect that can be improved upon, the program is among the best in the country in terms of ease of access and accuracy of information. 4. responsibilities and liability issues there are a number of responsibilities imposed upon dispensers of controlled substances covered by the inspect system.77 as mentioned briefly above, these responsibilities are basically in place to ensure that the data in the system reflects the quantity and identity of the drug a given individual has been prescribed. other requirements imposed on dispensers help to ensure that the prescription data corresponds to the correct individual.78 although clearly the inspect statutory scheme places significant responsibilities on dispensers, the same cannot be said with respect to physicians and other non-dispensing groups. 79 indiana law plainly states that all practitioners are under no obligation to reference the inspect database in writing any prescription to a given patient.80 additionally, all practitioners are immune from civil liability for either consulting or failing to consult inspect information, even where such act or omission has resulted in the injury or death of an individual.8 ' there are three narrow exceptions to this statutory protection. one is that if a practitioner 76 id. 77 see ind. code§ 35-48-7-8.1 (2012). 78 see id. 79 see id.; ind. code § 35-48-7-2.9 (2012); inspect faqs, in.gov, www.in.gov/pla/inspect/2371.htm (last visited may 20, 2013) (demonstrating that only dispensers are required to submit information to inspect, and there is no requirement for non-dispensers to do so). 80 ind. code § 35-48-7-11.1(k) (2012). 81 ind. code § 35-48-7-11.1(1) (2012). 718 vol. 10:2 indiana's inspect system receives direct information from the inspect system and negligently misuses it, there is a possibility for civil liability.82 the other two situations involve incidents of intentional misconduct by a practitioner. 3 such a broad scope of protection provided to practitioners probably indicates a legislative concern for avoiding the chilling effects on prescriptions discussed above. as mentioned, the legislature has made clear its intent to minimize inspect's impact on the treatment methods of practitioners in the state. if a violation of indiana's pmp laws is discovered, the punishment can be quite significant. in the realm of criminal liability, if the board of pharmacy believes that a violation has occurred, they may report relevant information to the appropriate authorities. 84 a knowing or intentional violation of inspect legislation constitutes a class a misdemeanor, 85 which can carry a punishment of up to a year in prison, and up to a five-thousand-dollar fine.86 however, if such a violation has occurred in the context of a good faith disclosure of inspect information to law enforcement authorities, the practitioner is immune from both criminal and civil liability.87 in relaying information to law enforcement, all practitioners benefit from a legal presumption of good faith in their conduct. 88 iii. analysis a. evaluating the inspect system the indiana legislature has expressed two primary goals of the inspect system: providing patient information storage for health care professionals and providing a resource for controlled substance investigations of law 82 id. 83 id. 84 ind. code § 35-48-7-11.1(m). 85 ind. code § 35-48-7-14 (2012). 86 ind. code § 35-50-3-2 (2012). 87 ind. code § 35-48-7-11.1(n) (2012). 88 id. 7192013 indiana health law review enforcement without interfering with practitioners' treatment methods. 89 additionally, the national alliance for model state drug laws (namsdl), an entity focused on unifying state monitoring programs and providing standards that the states may refer to in developing their pmp laws, has articulated further goals that all state pmps should seek to fulfill. 90 examining the inspect system while keeping all of these considerations in mind is an appropriate starting point in evaluating the efforts of the indiana legislature in combating the drug abuse problem in the state. 1. detecting and preventing abuse and misuse the first goal announced by namsdl is that of detecting and preventing abuse and misuse of prescription drugs covered by the pmp of a given state. 91 as can be seen in indiana's pmp laws and the aspects of the inspect system itself, this certainly seems to have been one of if not the central goal of the legislature and the program. 92 although the system is somewhat limited in that it produces reports on a reactive rather than a proactive basis, it still appears to provide enough information for authorized viewers to detect problematic prescriptions. the information that dispensers are required to submit to inspect provides authorized users with a valuable resource in recognizing such cases. 93 additionally, the fact that the information is relatively up to date, with the lag time for such information being no greater than seven days, helps to lessen the impact that the shortcomings of having a reactive system impose. 94 although the desire for even more up to date information is obvious, a maximum lag time 89 about inspect supra note 59. 90 blumenschein et al., supra note 33, at 3-4; see also model pmp, supra note 19. 91 blumenschein et al., supra note 33, at 3. 92 see generally ind. code § 35-48-7 (2012). 93 see ind. code § 35-48-7-8.1 (2012). 94 blumenschein et al., supra note 33, at 14-15. 720 vol. 10:2 indiana's inspect system of just a week makes inspect among the most current in the country. 5 although indiana is among the members of the national association of boards of pharmacy's interconnect program mentioned above, it is still somewhat limited in its ability to share prescription information across state lines.96 obviously, the more states that a given pmp can share information with, the better situation that state's system will be in attempting to deter doctor shoppers crossing state lines. therefore, continuing to achieve interoperability agreements should remain a priority in further developing inspect. 2. promoting proper use the namsdl also emphasizes the importance of states supporting the proper medical use of prescription drugs for which data is collected. 97 this probably reflects the general concern for the chilling effects on physicians' willingness to prescribe drugs covered by pmps for fear of liability. some opponents go so far to say that this potential effect is so significant that it places doubt on whether states should be using them at all. the indiana legislature too has recognized this risk, and as mentioned, has expressly stated that inspect is not meant to interfere with practitioners' abilities to treat patients in any respect.98 as further indication that the inspect system and its related legislation has taken the effects on treatment methods seriously, indiana law completely shields practitioners from any type of liability in all but a few specific instances, clearly lending support to the notion that indiana is attempting to promote the proper use of drugs covered by the system.99 however, when one considers that the incidents of drug abuse and misuse has continued to increase, it may be the case that such chilling effects are no 95 see id. 96 see nabp.net, supra note 38. 97 blumenschein et al., supra note 33, at 3. 98 about inspect supra note 59. 99 ind. code § 35-48-7-11.1(1) (2012). 2013 721 indiana health law review more than a mistaken theory and that such sweeping protection over compensates for them. such overcompensation may in turn limit the overall effectiveness of inspect and indiana pmp laws. 3. informing the public several of the goals announced by the namsdl are related to informing and assisting the public with regard to prescription drug abuse and misuse.100 this generally involves helping persons addicted to monitored substances seek treatment for their addiction, using the data from the system to develop methods of educating the public about the dangers of monitored drugs, and educating the public, as well as practitioners, about pmps and how they operate.101 consistent with this namsdl objective, indiana law allows for inspect data to be shared with certain substance abuse assistance programs.102 additionally, the indiana government has made a wide array of information pertaining to the dangers of prescription drugs, as well as information on the inspect system itself, available to the public through its official website.103 although the information provided is unquestionably useful in achieving the goals related to public education on this issue, the continued prevalence of prescription drug abuse and misuse clearly demonstrates a need for even more effort in bringing this issue to the attention of the public. currently, the information is available, but must be sought out by a given individual. many may be oblivious to, or simply unwilling to utilize the availability of such information, and more must be done to bring this issue to the attention of the public, rather than simply expecting the public to seek such information out independently. the more that people know about the dangers of prescription drug use, and the ability of pmps to detect abuse and 100 blumenschein et al., supra note 33, at 3-4. 101 id. 102 ind. code ann. § 35-48-7-11.1 103 see generally inspect home, in.gov, www.in.gov/pla/inspect/ (last visited may 20, 2013). 722 vol. 10:2 indiana's inspect system misuse, the more likely it is that they will be deterred from such use. therefore, continued efforts in this area are crucial not only in indiana, but nationally as well. 4. evaluation ofimpact the namsdl model laws include a section that promotes the existence of some evaluative entity in an effort to gage the impact that a given pmp is having on battling prescription drug abuse and misuse.10 4 such an entity would make annual findings related to cost-benefits of the program, overall impact on reducing prescription drug abuse, and impact on prescribing practices of practitioners, among other things. 105 indiana has not established such an entity, and no formal evaluation of the inspect program has yet been conducted. establishing an evaluation process would allow inspect officials to identify areas for improvement, as well as areas that appear strong, with greater ease. improving the program through this process would only serve to maximize the impact it has in combating prescription drug problems in indiana. 5. overall in comparing the operation of the inspect system with the goals announced by the namsdl regarding state pmps, it appears as if indiana has held many of the mentioned concerns at the forefront of consideration. that being said, there still appears to be room for improvement. the data that has been collected in recent years indicates that prescription drug injuries and deaths have continued to increase across the country despite the efforts of entities like namsdl and state legislators, including those of indiana, in developing pmp laws. 106 perhaps this suggests that new considerations and approaches must be taken in 104 model pmp, supra note 19, at § 12 (suggesting that reports be submitted to several federal and state "decision makers" for review and the designated state agency produce an annual report for the public). 105 id. 106 see generally paulozzi, supra note 15; girion, supra note 4. 2013 723 indiana health law review maximizing the ability of pmps generally, and inspect specifically, to combat the prescription drug epidemic. b. evaluation of indiana pmp laws despite the relative quality of the inspect system, the full extent of the prescription drug problem in indiana does not appear to be any less than is average among the states, particularly with respect to abuse and overdoses of prescription painkillers.107 this may be indicative of a potential problem in the governing legislation with regard to how the system is being utilized. this section will first examine the positive aspects of the indiana law, and then identify some problematic areas. 1. some positive aspects the measures taken by the indiana legislature ensure that the only groups authorized to view inspect data are those in a position to utilize it in furtherance of legitimate and substantial governmental interests in the area of public health and safety.108 further, authorized groups have strict limitations imposed upon them with respect to whom they may disclose prescription data,109 and violating these limits may carry significant legal consequences. 110 the information that is part of an inspect report is limited to that which is crucial for identifying the individual as well as whether or not there appears to be an issue regarding his or her prescriptions.11 ' having an effective pmp while maintaining confidentiality of patient prescription records is one of the central concerns that namsdl has set forth, and this aspect of the indiana law seems to have been centered on this consideration. 1 12 107 see paulozzi, supra note 10. 108 see ind. code ann. § 35-48-7-11.1 (west 2012). 109 see id. 110 see ind. code ann. § 35-48-7-14 (west 2012). 111 see ind. code ann. § 35-48-7-8.1 (west 2012). 112 see model pmp, supra note 19, at § 8 ("prescription monitoring information submitted to the [designated state agency or entity] 724 vol. 10:2 indiana's inspect system 72 another positive aspect of the inspect legislation is that it encourages practitioners that have reason to believe that an individual may be abusing or misusing prescriptions to take positive action by shielding good faith disclosures to appropriate authorized entities from carrying any type of liability.113 additionally, and as mentioned above, practitioners enjoy a presumption of good faith when such issues arise.114 again, this is consistent with the goals set forth by namsdl and may be the best way to incentivize practitioners to make such disclosures when they believe that an individual is abusing prescription drugs.115 2. some shortcomings in the law although there are clearly areas in which indiana's approach to combating prescription drugs are strong, the fact remains that others require improvement if the effectiveness of inspect is to be maximized. the inspect system has the potential to provide an invaluable resource in combating drug abuse and misuse throughout the state. however, it may be the case that some of the pmp legislation currently in place is preventing the system from reaching the height of such potential. namsdl suggests that state pmp laws should take into account the fact that many non-scheduled prescription substances are dangerous and abused with frequency." 6 aside from the fact that many non-scheduled substances are frequently abused, an additional problem is posed by the considerable risk of adverse drug interactions that many of these substances may create if taken in combination with other drugs, whether scheduled or not. because of these considerations, it is suggested that in the case of many of these non-scheduled prescription drugs, pmp laws should shall be confidential, is not subject to public or open record laws, and is not subject to disclosure or use except as provided in this section."). 113 ind. codeann. § 35-48-7-11.1 (west 2012). 114 id. 115 see blumenschein et al., supra note 32, at 3-4. 116 id. at 3. 2013 725 indiana health law review allow for data to be collected. 117 under its current pmp laws, indiana's inspect program has absolutely no authority to collect data on such substances in any situation. 118 statutory authority to monitor non-scheduled substances in certain situations seems to be completely consistent with the over-arching goal of the state in detecting and preventing prescription drug abuse, so it seems surprising that indiana law does not currently allow for any such data to be collected. additionally, allowing for the monitoring of some non-scheduled substances would provide enhanced protection against innocent misuse of adversely reacting drugs. although some may doubt the extent of the risk that such innocent misuse poses, allowing collection of such data could at the very least provide hard data useful in conclusively resolving the question of how much of an issue such misuse really is. all things considered, a change in indiana pmp legislation allowing for monitoring of certain non-scheduled substances is desirable. perhaps the biggest problem with indiana's current inspect legislation is that it does not impose any requirement that practitioners ever refer to the data stored in the system when writing a prescription. 119 when this is coupled with the fact any type of liability can only attach if inspect data has been accessed in the first place, 120 a glaring flaw in the current scheme comes into view. the scheme of the indiana pmp laws effectively creates an incentive for practitioners to forget or remain oblivious to the fact that such a resource is even available to them. by failing to refer to the prescription data held in the inspect system at all, practitioners can essentially eliminate any prescription related claims against them, which are already extremely limited by the terms of the relevant statute. while it is certainly the case that many if not most prescriptions have potential for damaging side effects to patients and that practitioners should not 117 id. 118 id. at 8; see generally ind. code ann. § 35-48-7 (west 2012). 119 see ind. code ann. § 35-48-7-11.1(k) (west 2012). 120 see ind. code ann. § 35-48-7-11.1(m) (west 2012). 726 vol. 10:2 indiana's inspect system generally be held accountable for such risks, allowing prescribers to make these drugs available to patients without any regard for further dangers is inexcusable, especially considering the ease with which such information can be obtained through the use of the inspect system. as discussed above, protecting practitioners from liability in certain situations is of great importance, not only to the viability of inspect and other pmps, but to healthcare in general. one such situation relevant to inspect information would be the case of a good faith disclosure of prescription data regarding a belief that an individual is abusing or misusing prescription drugs. however, the extent of and approach to protection of practitioners under the current statutory scheme in indiana may be limiting the effectiveness of inspect in achieving its maximum potential impact in combating the prescription drug epidemic in the state. because of these limitations, it must be said that the language of the law is inconsistent with the express goals behind the inspect legislation. not requiring practitioners to reference the inspect database in writing prescriptions creates a reasonable implication that the only real goal of the current pmp laws in indiana is to aid in criminal investigations and prosecutions, and that any goals seemingly related to furthering public health are illusory. c recommendations for change having examined the shortcomings of both the inspect system itself and of its governing legislation, the issue becomes the feasibility of addressing these problems in an effort to maximize the program's effectiveness. below are a number of key changes that can be made in indiana that seem achievable and likely to help the inspect system reach its full potential. 2013 727 indiana health law review 1. continue to increase number oflnteroperabiity agreements as mentioned above, indiana's inspect system is one of a number of leading state pmps in terms of sharing prescription data across state lines. 121 additionally, the official website of inspect has declared that illinois and kentucky will be added to the list of states indiana shares such information with beginning sometime in 2013.122 clearly this is a strong area of indiana's pmp program and its related legislation. however, despite the fact that indiana has made great strides in this area, more must continue to be done to ensure that interoperability can be achieved with as many states as possible. in a sense, this is not so much a recommendation for changes as it is a recommendation to take current efforts in this area even further in order to maximize indiana practitioners' ability to identify cases of doctor shopping across state lines. this in turn will almost certainly cause significant positive impact in reducing prescription drug abuse and misuse throughout the state. obviously, the ideal scenario would allow for the indiana system to exchange prescription data with any state. considering that many states have pmps that are only in the early stages of development, this seems to be a goal that remains out of reach for the immediate future. a much more realistic and achievable goal for the near future would be to reach agreements of interoperability with states that are in close proximity to indiana. the fact that inspect data is already being shared with ohio and michigan, and will begin to be shared with kentucky and illinois in 2013, is obviously an excellent start, as it means that indiana and all bordering states will be sharing prescription drug information in the near future. having this ability to share data will all bordering states creates an enormous obstacle to what would presumably be a majority of potential interstate doctor shoppers who travel to nearby states, rather than distant ones, to obtain the amount of a given 121 nabp.net, supra note 38. 122 about inspect supra note 59 (click "inspect at-a-glance"). 728 vol. 10:2 indiana's inspect system prescription they desire. however, the existence of such an obstacle will only create more incentive for these doctor shoppers to travel additional distances to other nearby states. therefore, continuing to develop such interoperability agreements should remain at the forefront of goals for the further development of inspect moving into the future. if indiana, and all states with operational pmps for that matter, took measures to ensure that prescription information could be shared throughout a given region, this will eventually result in a nation wide web of systems that would severely limit, if not completely eliminate the ability of individuals to doctor shop across state lines. 2. develop a more proactive system as mentioned briefly above, inspect is a reactive system, meaning that it produces reports on an individual patients prescription information only upon request from an authorized user of the system.123 it seems beyond any doubt that a more proactive system would be preferred to the current reactive one. developing a proactive system that is capable of self-analyzing and identifying problematic prescription cases could greatly increase the efficiency of the inspect system. this could take at least part of the element of human error in interpreting a given prescription report produced by the system out of the equation. however, as stated, no state has of yet been able to develop a fully effective proactive system. it may be possible that this could be achieved by implementation of some type of analytical software package or similar technology that identifies and flags suspicious cases and brings them to the attention of authorized users based on certain characteristics frequently indicative of misuse of prescription drugs. this would in turn enhance the already considerable potential of inspect to successfully combat prescription drug abuse and misuse across the state. this certainly seems to be something that at the very least is 123 see generally ind. code ann. § 35-48-7-8.1 (west 2012); see also blumenschein et al., supra note 33 at 14-15. 7292013 indiana health law review worthy of consideration, but because no such system has yet been developed, it poses the question of whether such increase in the sophistication of the program would be cost prohibitive. this is explored below in the section related to cost effectiveness. 3. create an independent evaluative entity as mentioned above, the namsdl recommends the creation of an evaluative entity to measure and report on the impact and effectiveness of pmps on prescription drug abuse and misuse in a given state. 124 while several states require the implementation of some type of advisory committee or other entity, indiana is not currently among them. 125 creation of such an entity in indiana would not only demonstrate the actual impact of inspect in combating the prescription drug problem, but also, it would help bring to light additional shortcomings of both the program and its governing legislation. the evaluative entity would have a number of responsibilities with respect to information related to the inspect system. for one, the entity could collect information from eligible users with an aim toward making the system as accessible and user friendly as possible. additionally, the entity could collect annual data related to both prescription drug related deaths and arrests, and which drugs created the largest source of problems to determine how effective prior efforts had been in combating prescription drugs, and where future efforts should be focused. creating such an entity could be of utmost utility in continuing to develop the inspect program in its ongoing battle against prescription drug abuse and misuse in indiana moving into the future. 124 model pmp, supra note 19, at § 12. 125 nat'l alliance for model state drug laws, states that mandate the use of an advisory committee, council, task force, or working group (july 31, 2012), http://www.namsdl.org/documents/statesthat mandatetheuseofanadvisorycommitteeetco7312012.pdf. it is worth noting that many of the states included on the map are those which indiana shares prescription data with, whether through an independently achieved agreement of interoperability, or through the nabp interconnect program. 730 vol. 10: 2 indiana's inspect system 4. allow for monitoring non -scheduled substances although clearly those scheduled substances which have been identified for their addictive and abusive tendencies pose what is probably the greatest risk to public health, this does not mean that they are the only threat. nine states have legislation in place which allows for monitoring of nonscheduled substances under certain circumstances.1 2 6 included amongst those states are kansas, north dakota, and ohio,127 all states with which indiana shares prescription information. while many of the states that have created such legislative authority have not yet begun to collect such data, the fact that the authority has been created demonstrates both that this is certainly a feasible notion and that this is a serious issue for which many states are seeking a remedy. in fact, it is suggested that the costs related to invasion of personal privacy are outweighed by the interests of monitoring such substances in some situations. accordingly, the indiana legislature should consider what situations might warrant such data collection. there are at least three key situations in which the monitoring of non-scheduled prescription substances should be allowed under indiana law. the first and probably most obvious scenario would be where the non-scheduled drug at issue has a tendency to be addictive or is abused with high frequency. this is consistent with the approach that namsdl recommends.128 a second situation would be one in which the non-scheduled drug at issue has a significant potential for dangerous drug interactions. another alternative to this would be a law that allows for collection of any non-scheduled prescription data on an individual already taking more than 3 prescriptions, as this is the point at which the potential for such dangerous interactions drastically increases.129 the third situation would involve 126 see blumenschein et al. supra note 33, at 8; see also nabp.net, supra note 38. 127 blumenschein et al. supra note 33, at 8. 128 id. at 3. 129 avoiding drug interactions, supra note 24. 7312013 indiana health law review individuals who voluntarily agree to have such information submitted in an attempt to enhance their protection against adverse drug interactions. it is important to note that none of the above suggestions are intended to affect the strict confidentiality and disclosure rules already in place. additionally, the information that would be submitted to inspect under these proposed changes would already be collected for the records of the prescribers and dispensers, meaning any invasion of patient privacy is going to occur regardless of whether that information is then turned over to inspect. the inspect system simply provides a database on a much larger scale. therefore, any further invasion to patient privacy as a result of these changes would be effectively negligible. it should be noted with respect the second and third situations mentioned above that, although traditionally when we think about overdoses, we often assume that one drug is to blame, the reality is that a huge portion of deaths result from accidental drug interactions. 13 0 as discussed above, a considerable percentage of the population in the u.s. takes more than four prescription drugs at any given time, while taking more than three prescriptions is said to drastically increase the chances of dangerous drug interactions. 1 3 1 when one considers that there is ample data and literature illustrating the very real dangers of adverse drug interactions, the true weight of these numbers becomes hard to ignore. a significant portion of citizens in this country are consuming a dangerous amount of prescriptions, many of which we now know to interact adversely with one another. this is clearly an enormous threat to public health and yet it likely only begins to tell the whole story with respect to the dangers of taking so many prescriptions, as many if not most drug interactions are "discovered by accident and entirely too late or are not discovered at all because people may not equate their 130 january w. payne, a dangerous mix, wash. post, feb. 27, 2007, at f01, available at http://www.washingtonpost.com/wp-dyn/ content/article/2007/02/23/ar2007022301780.html. 131 avoidng drug interactions, supra note 24. 732 vol. 10:2 indiana's inspect system symptoms to their medications."13 2 all things considered, until more is done to determine the full extent of the problems such interactions pose, the enormous amount of people taking a dangerous amount of prescriptions justifies making some efforts toward protecting against these risks, whether known or unknown. 5. require practitioners to consult the inspect database perhaps the biggest problem facing inspect in reaching its full potential in terms of impact on the prescription drug problem is simply the fact that it is not being used by enough indiana practitioners on a regular basis. this is largely related to the fact that indiana law places no requirement upon practitioners to reference the system before writing a prescription.13 3 according to the director of inspect, marty allain, only somewhere around thirty-three percent of eligible physicians in the state are even registered to use the system.134 considering that inspect is among the leading pmps in the country and the first program to offer several key features, such as interstate sharing and data integration,135 it is remarkable that such a large percentage of physicians are not even registered to access its contents, let alone use them as an integral tool in the prescribing process. because they are not required to use the information held within the system, 132 joseph mercola, accidental prescription drug deaths spike upward, mercola.com (sept. 22, 2009), http://articles.mercola.com/ sites/articles/archive/2009/09/22/accidental-prescription-drug-deathsspike-upward.aspx. 133 ind. code ann. § 35-48-7-11.1(k) (west 2012). 134 marty allain, oag task force subcommittee update, jan. 7, 2012 (a power point presentation created by mr. allain listing percentages of other types of practitioners registered to use inspect: fifty-four percent of clinical nurse specialists; twenty-eight percent of csr-certified nurse midwives; forty-four percent of csr-osteopathic physicians; thirty-six percent of dentists; forty-six percent of nurse practitioners; twenty-nine percent of pharmacists; forty-one percent of physician assistants; and thirty one percent of podiatrists.) 135 e-mail from marty allain, director, inspect, to jacob o'brien (jan. 28, 2013) (on file with author). 7332013 indiana health law review many practitioners in indiana may not even be aware of exactly what inspect is, let alone what its goals are and how to use it effectively. with such an accessible and valuable resource in combating one of the most pervasive health issues facing indiana, and the entire country, at their disposal, allowing practitioners to continue to approach treatment without ever even considering it is simply unacceptable. although inspect enjoys the support of many of the practitioners who do use the system, many of whom advocate the furtherance of its use, this alone is not enough to implement they system to its full extent. so long as there is no legal requirement to check inspect in writing a prescription, the system will never reach its full potential, and the immense benefits that the indiana legislature aspired to in developing the program will never be realized. there are currently twelve states with legislation in place requiring prescribers and dispensers to access pmp information in certain circumstances. 136 for several of these states, this is a new component of their respective pmp legislation, and will become effective beginning in 2013.137 one approach in such legislation is to require prescribers and dispensers to examine prescription data related to a prior twelve month period before completing such a transaction. 138 interestingly, during the drafting of this note, a bill was introduced before the indiana legislature that would have added indiana to the list of states that require healthcare practitioners to reference pmp data before prescribing, dispensing, or administering a controlled substance. 139 136 nat'l alliance for model state drug laws, states that require prescribers and/or dispensers to access pmp information in certain circumstances (sept. 12, 2012), http://www.namsdl.org/ documents/statesthatrequirepractitionerstoaccessincertaincircum stances09122012.pdf. 137 id. 138 blumenschein et al., supra note 33, at 9 (discussing nevada's approach). 139 h.b. 1465, 118th gen. assemb., reg. sess. (ind. 2013), available at http://www.in.gov/legislative/bills/2013/in/in1465.1.html (as introduced on jan. 22, 2013). 734 vol. 10:2 indiana's inspect system specifically, the bill proposed to require such a practitioner to use inspect prior to taking the given action when the amount of the substance given "exceeds a thirty day supply for treatment of a patient."140 however, the bill did not squarely address the consequences that would follow from a failure to observe this reporting procedure. 141 presumably, the general provisions regarding violation of inspect laws would apply, meaning that failure to comply could have constituted a class a misdemeanor.142 adopting this requirements would obviously have been a huge step towards maximizing the ability of inspect to combat prescription drug abuse and misuse in indiana.143 the inspect system is an enormous resource that can have great impact in combating the public health nightmare that prescription drug abuse has created, and failure to use this information that is so easily and readily accessible is simply unacceptable. holding practitioners accountable for failure to use such a valuable tool would simply be a reflection of the fact that society expects providers of healthcare to make decisions related to individual patients based on all relevant and available information. anything short of that should simply be recognized for what it is: clear neglect of occupational and professional duty. because the inspect system can only be of utility if it is actually being used, i would suggest development of legislation that at the very least requires the approach discussed above regarding states that require practitioners and dispensers to reference pmp information, as well as the bill that is currently being discussed in the indiana legislature. tracking whether a required individual referenced the appropriate data would be as simple as creating an access log within the inspect system that 140 id. 141 [d 142 see ind. code ann. § 35-48-7-11.1 (west 2012); ind. code ann. § 35-50-3-2 (west 2012). 143 while the bill was ultimately enacted, substantial amendments were made during the legislative process that resulted in the removal of the referencing requirement. see h.b. 1465, 118th gen. assemb. reg. sess. (ind. 2013) (enrolled act), available at http://www.in.gov/ legislative/bills/2013/he/he 1465.1 .html. 7352013 indiana health law review would show when such a user accessed the system, and requiring that this information also be included as part of the prescribing transaction and submitted to the inspect system. failure on the part of a practitioner to consult the system should result in subjecting him/her to liability where such failure results in injury or death. immunity should otherwise be preserved as established by current indiana law. in other words, so long as a practitioner consults the system, examines its data in good faith, and does not engage in conduct that would subject him/her to liability under current indiana law, he should be deemed immune from suit. opponents to this approach would likely condemn it as an enhancement of the feared chilling effects that pmps and associated legislation can have, as discussed above. as much of this paper demonstrates, any fear or chilling effects appears to be simply unfounded. more prescription drugs are still being produced every year than in the preceding year, and deaths from prescriptions have continued to rise. the drugs would not be as readily available as necessary for such impact if the supposed chilling effect were having any significant impact on practitioners. another possibility to consider is that enhancing any type of chilling effect on practitioners in how they write prescriptions may not be all bad. as discussed earlier, a substantial portion of people are prescribed a dangerous amount of prescriptions. perhaps forcing practitioners to exercise more discretion before they pull out their prescription pad may be a good thing, and could result in reducing this number. in turn, this would reduce the risk that such drugs pose to patients. the inspect system has the potential to make an enormous impact in combating the prescription drug problem in indiana, but this can only be achieved if the system is actually being put to use by practitioners in the state. the proposed approach is a reasonable and achievable means of helping the utility of the system reach its optimal level. 736 vol. 10: 2 indiana's inspect system d. cost effectiveness obviously, most if not all of the recommendations made above with respect to improving the inspect system and its governing legislation could potentially lead to additional costs in the operation of the system. it is difficult to predict exactly what the extent of these additional costs would be, and such price determinations with respect to those costs are beyond the scope of this note. however, it is also clear that a discussion of the viability of making such improvements to the inspect system cannot be complete without considering such costs, at least to some degree. to begin the discussion of adding additional costs to the operation of inspect, one must first have some idea of the current cost and how it compares with other states. in looking at the normal range of funding costs for pmps, it appears that even the most expensive programs have annual budgets no greater than one million dollars. 144 when one considers the enormity of overall state budgets, it must be said that pmps are operated at relatively low cost. indiana's budget for inspect is around $450,000 annually.145 the average budget for states with a population of three-and-a-half million or greater is $607,000, and the average budget for the states surrounding indiana is $927,350, clearly illustrating that the costs of operating inspect are relatively low when compared with similarly situated state programs.146 additionally, inspect receives significant federal funding from the harold rogers grant program related to assisting states in operating pmps.147 in fact, it appears as if around three fourths of inspect's budget comes from such federal grants.148 this serves to minimize the amount 144 blumenschein et al., supra note 33, at 10; see also marty allain, oag task force subcommittee update, jan. 7, 2012 (a power point presentation created by mr. allain). 145 marty allain, director, inspect, oag task force subcommittee update (jan. 7, 2012). 146 id, 147 about inspect supra note 59. 148 allain, supra note 145. there has been some suggestion during the drafting of this note that the federal funds made available through 7372013 indiana health law review of indiana money that is required for the operation of the system. the remainder of the funding is currently sourced in a percentage of state controlled substance registration fees. 149 however, in the same bill discussed above that would have required practitioners to use inspect, it was proposed that, instead of taking merely a percentage of such controlled substance registration fees, the entire amount would be included in the inspect budget. 150 this portion of the bill survived and becomes effective july 1, 2013.151 these additional funds may allow for such recommendations as laid forth above to become readily achievable without having to create further sources of funding. another important consideration in assessing whether additional costs associated with the operation of inspect would be justified is the enormous cost already being paid related to prescription drug abuse. for example, there is ample data to suggest that abuse rates of prescription drugs are highest in low-income, medicaid-dependent demographics. 152 when one considers that government money is currently being indirectly used to support the addictions to prescriptions of many people, the net effect of broadening the scope of inspect by incorporating the suggestions above might actually be to reduce the overall costs associated with prescription drug abuse and misuse. even if more state funds were to be required, it seems unlikely that the costs would render such improvement of the program unattainable. the potential impact that the harold rogers program may be reduced or eliminated entirely in the not so distant future. if this becomes a reality, then the bill currently being considered would become vital to the continued success and development of the inspect program.) 149 about inspect supra note 59. 150 h.b. 1465, 118th gen. assemb. reg. sess. (ind. 2013), available at http://www.in.gov/legislative/bills/2013/in/in1465.1.html (as introduced on jan. 22, 2013). 151 h.b. 1465, 118th gen. assemb. reg. sess. (ind. 2013) (enrolled act), available at http://www.in.gov/legislative/bills/2013/he/he1465.1. html. 152 ass'n of st. and territorial health officials, prescription drug overdose: state health agencies respond 4 (2008), available athttp://www.cdc.gov/homeandrecreationalsafety/pubs/rxreport-web-a.pdf. 738 vol. 10:2 739indiana's inspect system improving the system in the various ways mentioned above could have on the effectiveness of this already valuable resource may very well justify any additional costs. at the very least, the suggestions made above as well as ways to fund them should continue to be explored moving into the future. iv. conclusion the measures taken by the indiana legislature in developing the inspect system have created a valuable foundation for combating the prescription drug problem in the state. while the system is relatively strong when compared to pmps of other states, there remain a number of shortcomings in both the system itself and its governing legislation. these shortcomings are preventing inspect from reaching its full potential in terms of bringing this problem under control. the suggested changes to indiana pmp legislation made in this paper provide reasonable means of ensuring that inspect continues to advance toward reaching its full utilitarian potential. 2013 microsoft word final for lulu vol. 14 issue 1 final how can collaboration help alleviate harm in the flint water crisis? could interprofessional have prevented the flint water crisis http://doi.org/10.18060/3911.0028 see, e.g. 100 faces of flint residents bring water crisis to life see also flint water crisis, 104 years ago today: general motors was born in flint flint, id. see, e.g. id. flint’s population falls below 100,000 for first time since the 1920s supra id. quick facts, flint city, michigan supra supra et seq. repealed by id. repealed by repealed by repealed by repealed by repealed by see how did we get here? a look back at michigan’s emergency manager law, michigan proposal 1: voters reject measure, repeal controversial emergency manager law see see also some laws shielded from voter referendum flint emergency: timeline of state takeover closing the valve on history: flint cuts water flow from detroit after nearly 50 years last portion of kwa pipeline installed about resolution authorizing approval to enter into a professional engineering serivces contract for the implementation of placing the flint water plant into see also michigan truth squad: who approved awitch to flint river? state’s answers draw fouls upra flint residents should be drinking flint river water by mid-april, officials say new um-flint research shows location of lead pipes in flint why didn’t flint treat its water? an answer, at last see, e.g. city adding more lime to flint river water as resident complaints pour in how gm saved itself from flint water crisis rusting engine blocks flagged big problem, general motors plant won’t use flint water until kwa pipeline complete events that led to flint’s water crisis id. without these whistleblowers, we may never have known the full extent of the flint water crisis virginia tech expert helped expose flint’s water crisis pediatric lead exposure in flint, mi: concerns from the medical community flint reconnects to detroit water, may take 3 weeks to clear all pipes state of emergency declared in the city of flint analysis: how michigan and national reporters covered the flint water crisis https id. see, e.g. flint’s broken trust: ‘i just can’t continue living like this poll: is filtered flint water safe to drink? flint-area's first legionnaire's disease case confirmed for 2016 see, e.g. water crisis demonstration uses 80 cases of bottled water fill kiddie pool flint lives matter overcomes funding challenges to give out more water federal state of emergency over lead-laced water ends in flint, mich. lead removal from flint water making progress, researchers find, see also virginia tech research team says flint water improving, but still unsafe to drink, what can be done to encourage more interprofessional collaboration in health care? see interprofessional collaboration: three best practice models of interprofessional education, a. how can interprofessional collaboration help alleviate further harm in the flint water crisis? interprofessional collaborative practice model, see reducing health disparities in underserved communities via interprofessional collaboration across health care professions flint’s growing mental health crisis http https://doi.org/10.2147/jmdh.s74129 msu-hurley children’s hospital pediatric public health initiative id. addressing the public health crisis in flint id. wayne state research team to evaluate possible link between flint water system and health problems, b. could interprofessional collaboration have prevented the flint water crisis? cdc investigation: blood lead levels higher after switch to flint river water, id. see the heroic professor who helped uncover the flint lead water crisis virginia tech expert exposed flint water crisis the water crisis in flint is ‘an entirely preventable man-made disaster’ see e.g. how to prevent the next flint could what happened in flint happen anywhere? health in all policies: a guide for state and local governments id. beyond flint: in the south, another water crisis has been unfolding for years id. a national water crisis: fixing the water infrastructure is one of the greatest challenges of our time. public health 3.0 public health 3.0: time for an upgrade public health 3.0 see public health 3.0: time for an upgrade see, e.g. lead in the water: the crisis is not solely flint’s see also n indiana city is poised to become the next flint ihlr vol 14 iss. 2.pdf http://doi.org/10.18060/3911.0037 indiana health law review volume9 2012 articles what to do when you can't hear the wbistleblowing: a proposal to protect the public's health by providing wbistleblower protection for issue 1 medical researchers jennifer s. bard the forgotten patient: a health provider's guide to providing comprehensive care for transgender patients nikki burrill & valita fredland extending the fantasy in the supermarket: where unhealthy food promotions meet children and how the government can intervene jennifer l. pomeranz notes the case for pharmacists as legal health care providers erin albert keeping your head on straight: protecting indiana youth athletes from traumatic brain injuries through "return-to-play" legislation andrew w. breck where do treating physicians belong as witnesses in the seventh circuit? courtney e. campbell nurses providing anesthesia not a "laughing" matter: why indiana should not opt out of federal physician supervision of certified nurse anesthetists requirements kyle k. fairchild state challenges to the patient protection and affordable care act: the case for a new federalist jurisprudence christopher b. serak a dose of reality: unintended consequences of penalizing hospital readmissions in the ppaca joel d. swider robert h. mckinney school of law indiana university indianapolis indiana health law review volume9 etlitor-ln-chief courtney campbell execlltive m111111ging editor joel swider executive production editon kate cook alexander berger executive bjisiness editor brienne delaney note development editon erin albert, mba, at1klesediton kyle fairchild macon jones kate shelby 2011-2012 execlltive notes editor lesley brown executive articles editor andrew breck executive sylnposl111n editor lance worland assocltlte editors leeannpels beth pirro ash lee talley pharmd ashley brian kyle johnson alex krouse chris serak ellen wintemheimer gunnar crowell j.b. curry cora davidson brock easton james emerson daniel hageman julia hudson james inman alyssa james fulllty advison jennifer risser kimberly opsahl justin rumer myriam serrano frandy st. louis william starr lindsey stout pervin taleyarkhan kyle wood nicolas p. teny(chair) david orentlicher (chair) eleanor 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of law. virginia marschand, director of administrative and fiscal affairs. b.s., indiana university-kokomo; m.p .a., indiana university purdue university-indianapolis; j.d., indiana university robert h. mckinney school of law. john r. schaibley, iii, executive director of the center for intellectual property law and innovation and adjunct professor of law. b.a., purdue university; j.d., indiana university maurer school of law. sonja rice, director of special projects. b.a., purdue university; j.d., indiana university robert h. mckinney school of law. law anda w. w aiid, director of pro bono and public interest programs. b.a., murray state university; m.a., illinois state university; m.s., old dominion university; j.d., indiana university robert h. mckinney school of law. jacob j. manaloor, associate director for contracts, grants & fundraising. b.s., indiana university purdue university-indianapolis; j.d., indiana university robert h. mckinney school of law. sean soutiiern, associate director, office of professional development. b.a., ball state university; m.a., depaul university; j.d., loyola university chicago school of law. carlota toledo, associate director of student affairs. a.b., university of chicago; j.d., depaul university college of law. susan k. agnew, assistant director of student affairs. clark college. wll.llam j. baker, assistant director of technology services. b.s., purdue university. amanda gau..aga, assistant director of recruitment. b.a., trinity university. susanbushue-russeil,assistant business manager. a.a.s., lakeland college; b.s., eastern illinois university. karen h. miller, assistant director for admissions. midway college. lisa schrage, assistant director for donor relations. b.s., marian college. mel yndiz, assistant director of graduate admissions. ll.b., istanbul bilgi university faculty oflaw; ll.m., indiana university robert h. mckinney school oflaw; j.d. candidate, indiana university robert h. mckinney school of law. faculty cynthia m. adams, clinical professor of law. b.a., kentucky wesleyan college; j.d., indiana university robert h. mckinney school oflaw. judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. cynthia a. baker. clinical associate professor of law and director, program on law and state government. b.a., j.d., valparaiso university. gerald l. bepko,indiana university-purdue university-indianapolis chancellor emeritus, indiana university trustee professor and professor of law. b.s., northern illinois university; j.d., fit/chicago-kent college oflaw; ll.m., yale law school. shawn boyne, associate professor of law, dean's fellow; grimes fellow. b.a., cornell university; m.b.a., university of minnesota; j.d., university of southern california's gould school of law, m.a., ph.d., university of wisconsin; ll.m., justus-liebig-universitll.t. karen e. bravo, professor of law, johns. grimes fellow; dean's fellow. b.a., the university of the west indies; j.d., columbia university school oflaw; ll.m., new york university school of law. robert brookins, professor of law. b.s., university of south florida; j.d., ph.d., cornell university. kenneth d. chestek, clinical professor of law. b.a., pennsylvania state university; j.d., university of pittsburgh school of law. jeffreyo. cooper, associate professor of law. a.b., harvard university; j.d., university of pennsylvania law school. eric r. dannenmaier, associate professor of law, dean's fellow; grimes fellow. b.a., drury college; j.d., boston university; ll.m., columbia university; m. st., oxford university. james d. dimitri, professor of law. b.s., indiana university; j.d., valparaiso university school of law. jennifera. drobac, professoroflaw. b.a., m.a., stanford university; j.d., j.s.d., stanford law school. george e. edwards, carl m. gray professor of law; faculty advisor to the u.m. track in international human rights law (u.m. faculty advisor term ending spring 2011); director, program in international human rights law; john s. grimes fellow. b.a., north carolina state university; j.d., harvard law school. frank emmert, johns. grimes professor of law and executive director, center for international and comparative law. erstes juristisches staatsexamen (j.d.), university ofmunich law school; ll.m., the university ofmichigan law school; ph.d., university of maastricht; diploma. ew"opean university institute. nicholasgeorgakopouws,haroldr. woodardprofessoroflaw. ptyhionnomikis, athens university school of law; ll.m., s.j.d., harvard law school. carrie hagan, clinical associate professor of law. b.a., university of kansas; j.d., university of cincinnati college of law. john lawrence hn.l. professor·of law. b.a., northern lllinois university; j.d., ph.d., georgetown university. linda keu.y hn.l. m dale palmer professor of law. b.a., j.d., university of virginia. maxhuffman,associate professoroflawanddean 's fellow. b.a., cornell university; j.d., university of cincinnati college of law. lawrence a. jegen, iii, thomas f. sheehan professor of tax law and policy. b.a., beloit college; j.d., m.b.a., university ofmichigan; ll.m., new york university school of law. robert a. katz, professor of law. a.b., harvard college; j.d., university of chicago law school. andrewr. klein, paul e. beam professor of law; chief of staff, office of the chancellor of iupui. b.a., university ofwisconsin; j.d., emory university school of law. normanlefstein, professor of law and dean emeritus. ll.b., university oflllinois college of law; ll.m., georgetown university law school. gerard n. maguocca, professor of law and grimes fellow. b.a., stanford university; j.d., yale law school. allison martin, clinical associate professor of law. b.s., j.d., university of illinois. deborah mcgregor, clinical professor of law and assistant director of legal analysis, research and communication. b.a., university of evansville; j.d., georgetown university law center. emu. y morris, associate professor oflaw and dean's fellow. a.b., harvard university; j.d., university of michigan law school. novella nedeff, clinical associate professor of law. b.a., j.d., indiana university. david orentucher, samuel r. rosen professor of law and co-director of the william s. and christine s. hall center for law and health. b.a., brandeis university; j.d., m.d., harvard university. joanne orr, clinical professor of law. b.s., indiana state university; j.d., california western school oflaw. antony page, professor of law and dean's fellow; director, central & eastern european law summer program. b. comm., mcgill university; m.b.a., simon fraser university; j.d., stanford law school. h. kathleen patchel, associate professor of law. a.b., huntington college; j.d., university ofnorth carolina law schoot ll.m., yale law school. michael j. pitts, associate professor of law; dean's fellow and john s. grimes fellow. b.s.j., northwestern university; j.d., georgetown university law center. peter a. prescott, associate professor of law. b.a., augustana college; m.s., the university of chicago; m.p.a., the university of texas at austin; j.d., the university of houston law center. fran quigley, clinical professor of law, health and human rights clinic, indiana university robert h. mckinney school of law; senior advisor, indiana university center for global health. b.a., hanover college; m.a., indiana university; j.d., indiana university robert h. mckinney school of law. florence wagman roisman, william f. harvey professor of law. b.a., university of connecticut; ll.b., harvard law school. joan m. ruhtenberg, clinical professor of law and director of legal analysis, research and communication. b.a., mississippi university for women; j.d., indiana university robert h. mckinney school of law. joel m. schumm, clinical professor of law. b.a., ohio wesleyan university; m.a., university of cincinnati; j.d., indiana university robert h. mckinney school of law. lahnyr. silva, associate professor of law. b.a., m.a., boston university; j.d., university of connecticut school oflaw; ll.m., university ofwisconsin law school. margaret c. tarkington, associate professor of law. b.a., brigham young university; j.d., j. reuben clark law school, brigham young university. carlton mark w aterhouse,associateprofessoroflaw; dean's fellow. b.s., pennsylvania state university; j.d. with honors, howard university school oflaw; m.t.s., emory university, chandler school of theology; ph.d. with honors, emory university. frances watson, clinical professor of law. b.s., ball state university; j.d., indiana university robert h. mckinney school of law. lloyd t. wilson, jr., professor of law; director, joint center for asian law studies; director, chinese law summer program; director, american law for foreign lawyers ll.m program. b.a., wabash college; m.a., duke university; j.d., indiana university maurer school of law. r. george wright, lawrence a. jegen iii professor of law. a.b., university of virginia; ph.d., indiana university; j.d., indiana university robert h. mckinney school of law. emeriti faculty thomas b. allington, professor of law emeritus. b.s., j.d., university ofnebraska; ll.m., new york university school of law. enw ard p. archer, professor of law emeritus. b.m.e., renesselaer polytechnic institute; j.d., ll.m., georgetown university law school. james f. bailey, ill, professor of law emeritus. a.b., j.d., m.a.l.s., the university of michigan. clyde harrison crocketi, professor of law emeritus. a.b., j.d., university of texas; ll.m., university of london (the london school of economics and political science). debra a. f alender, professor of law emerita. a.b., mount holyoke college; ld., indiana university robert h. mckinney school of law. david a. funk, professor of law emeritus. a.b., college of wooster; j.d.,. case western reserve university school of law; m.a., the ohio state university; ll.m., case western reserve university; ll.m., columbia law school. paul j. galanti, professor of law emeritus. a.b., bowdoin college; j.d., university of chicago law school. helen p. garfield, professor of law emerita. b.s.j., northwestern university; j.d., university of colorado school oflaw. harold greenberg, professor of law emeritus. a.b., temple university; j.d., university of pennsylvania law school. jeffrey w. grove, professor of law emeritus. a.b., juniata college; j.d., george washington university law school. wiluam f. harvey, carl m gray professor of law & advocacy emeritus. a.b., university of missouri; j.d., ll.m., georgetown university law school. w. wiluam hodes, professor of law emeritus, a.b., harvard college; j.d., rutgers university school of law-newark. wiluam andrew kerr, professor of law emeritus. a.b., j.d., west virginia university; b.d., duke university; ll.m., harvard law school. eleanordearmanklnney, hall render professoroflaw, co-director of the williams. and christine s. hall center for law and health emerita. b.a., duke university; m.a., university of chicago; j.d., duke university school of law; m.p.h., university of north carolina. wiluam e. marsh, professor of law emeritus. b.s., j.d., university ofnebraska. susanahm. mead, professor of law emerita. b.a., smith college; j.d., indiana university robert h. mckinney school of law. ronald w. polston, professor of law emeritus. b.s., eastern illinois university; ll.b., university of illinois college of law. kenneth m. stroud, professor of law emeritus. a.b., j.d., indiana university­ bloomington. james w. torke, carl m gray professor of law emeritus. b.s., j.d., university of wisconsin. james patrick widte, professor of law emeritus. a.b., university of iowa; j.d., ll.m., george washington university law school. lawrence p. wn.kins, william r. neale professor of law emeritus. b.a., the ohio state university; j.d., capitol university law school; ll.m., university oftexas school of law. mary therese wolf, clinical professor of law emerita. b.a., saint xavier college; j.d., university oflowa college oflaw. ruth luly law library faculty judith ford anspach, professor of law and director, ruth lilly law library. b.s., m.l.s., kent state university; j.d., mississippi college school of law. debra densla w, reference librarian. b.a., franklin college; m.s., university of illinois, urbana-champaign; j.d., valparaiso school oflaw. richard humphrey, reference librarian. a.a., brewton-parker junior college; b.a, georgia southwestern college; m.l.s., university of kentucky. wendell e. johnting, cataloging and government documents librarian. ab., taylor university; m.l.s., indiana university. catherine lemmer, head of information services. b.a., lawrence university; j.d., university of wisconsin; m.s., university of illinois. chris e. long, cataloging librarian. b.a., indiana university; m.a, indiana university; m.l.s., indiana university. stevenr. miller, reference librarian. b.s., lebanon valley college ofpennsylvania; m.a., dominican university; m.s., northwestern university; j.d., the john marshall law school. mahnaz k. moshfegh, serials/acquisitions librarian. b.a., national university of iran; m.s., tehran university; m.a., ball state university; m.l.s., ph.d., indiana university. miriam a. murphy, associate director. b.a., purdue university; j.d., m.l.s., indiana university-bloomington. kiyosm otsu,automated services and media librarian. a.a., parkland college; a.b., m.s., c.a.s., university of illinois. indiana health law review volume9 table of contents articles what to do when you can't hear the whistleblowing: a proposal to protect the public's health by providing whistleblower protection for issue 1 medical researchers ............................................................... jennifer s. bard 1 the forgotten patient: a health provider's guide to providing comprehensive care for transgender patients ........................ nikki burrill & valita fred/and 69 extending the fantasy in the supermarket: where unhealthy food promotions meet children and how the government can intervene ................................................................. jennifer l. pomeranz 117 notes the case for pharmacists as legal health care providers ............ erin albert 187 keeping your head on straight: protecting indiana youth athletes from traumatic brain injuries through "return-to-play" legislation ............................................................................. andrew w. breck 215 where do treating physicians belong as witnesses in the seventh circuit? .......................................................................... courtney e. campbell 247 nurses providing anesthesia not a "laughing" matter: why indiana should not opt out of federal physician supervision of certified nurse anesthetists requirements .......................................... ky/e k. fairchild 281 state challenges to the patient protection and affordable care act: the case for a new federalist jurisprudence ................. christopher b. serak 311 a dose of reality: unintended consequences of penalizing hospital readmissions in the ppaca ..................................................... joel d. swider 361 2012 stark inaccessibility of medical care in rural indiana: judicial and legislative solutions, the the stark inaccessibility of medical care in rural indiana: judicial and legislative solutions thomas f. martin ii' part i ............................................ 833 a. geographic accessibility. hospitals..... ...... 833 b. medically underserved areas and populations in indiana..................................837 c. health professional shortage areas...........839 partii ......................................... 841 a. medical malpractice and its effects .............. 841 b. the conception and history of the locality rule.843 c. the modified locality rule debuts in indiana jurisprudence ....................... ..... 845 d. the modified locality rule as a solution to inaccessibility ................... ............. 849 e. gross negligence as a solution to inaccessibility. 855 part iii .................................... 860 a. existing accessibility programs .............. 860 b. critical access hospitals......... ........... 864 c. geographic accessibility. state-owned and opera ted critical access hospitals and support for the establishment ofacute care and primary care hospitals ......................... ............ 865 d. medical personnel accessibility: the 'pay-to-drive" and the "rural practice benefits program"..........872 e. conclusion........................874 j.d. candidate, 2014, indiana university robert h. mckinney school of law, indianapolis, indiana; b.a., may 2010, indiana university, bloomington, indiana. indiana health law review introduction there is a widespread disparity of accessibility to medical care within indiana. this disparity of access to quality health services in certain areas of indiana is seemingly nothing less than a full blown crisis. while much recent legislative focus and attention have been devoted to medical insurance coverage, a general lack of accessibility to healthcare, especially in rural areas, has remained unsettled. this article outlines the maldistribution of hospitals and healthcare professionals within indiana with a focus on a comparative analysis of rural and urban locales, and it also seeks to explore and offer legal solutions to this humanitarian inequity. in part i of this note, the nature and scope of the inaccessibility to medical facilities and the shortage of medical professionals in rural areas within indiana are highlighted. in particular, the geographic placement of hospitals throughout the state is analyzed. additionally, data on the extent of primary care physician availability in rural areas is reviewed. moreover, in part ii of this note, medical malpractice and the effects thereof are examined in the context of the absence of adequate access to healthcare institutions and the waning number of medical professionals practicing in rural indiana. judicial measures may exist to remedy, to a certain extent, the inaccessibility of medical care in rural areas. principally, two judicial measures will be proposed in part ii of this note. these include adoption of the modified locality rule as the standard of care for rural physicians and alternatively the adoption of gross negligence as the threshold of malpractice liability for rural physicians. additionally, comprehensive legislative measures are also available to combat the inaccessibility of medical care in rural areas. primarily, two legislative measures will be of focus in part iii of this note. these are the establishment of state-funded and operated hospitals and the establishment of a program which would facilitate the 832 vol. 11:2 medical care in rural indiana redistribution of medical professionals from large cities to rural indiana. part i accessibility of medical care within certain areas of indiana is shockingly limited. these areas tend to constitute agrarian locales. in order to accurately portray the current state of accessibility to medical treatment within these non-urban locales, two types of medical care accessibility will be assessed in this note. these are geographic and medical personnel accessibility. geographic accessibility, usually referred to as medically underserved areas or populations, constitutes the availability of medical facilities or services in a certain locale or area. medical personnel accessibility, herein often referred to as health professional shortage areas, means the adequacy or inadequacy of the amount of certain medical professionals given their ratio to the population of a certain geographic area. a. geographic accessibility: hospitals hospitals play a vital role throughout the healthcare infrastructure in delivering many types of health services. hospitals, through their physicians and staff, most notably bear the assumed responsibility of diagnosing a plethora of ailments and diseases, establishing efficient systems for the provision of preventative care, responding to epidemics and other health crises, treating infectious disease, performing complex inpatient and outpatient surgeries, treating severe injuries under extenuating circumstances, and providing means of long term care. these services are indispensable to maintaining the well-being of many americans, and indirectly the availability of these services helps to maintain a thriving society. specifically, proper and robust healthcare delivery intuitively effectuates healthier living. in turn and generally speaking, a healthy population is likely to be more productive than is one that struggles to obtain and maintain 2014 833 indiana health law review good health.' this is due to the straightforward notion that people who suffer inadequate health services are corporally less capable of bearing the demands of activity. in other words, sickness of the human body takes an adverse toll on human happiness and productivity, and thus illness takes priority in everyday living. contrarily, healthy populations are better able to center and focus their energies on endeavors such as education, commerce, philanthropy, and artistic expression, which as a result benefits society as a whole. hospitals act as the foundation of the healthcare delivery system which is integral to societal health and productivity. as of 2010, there are sixteen rural counties in indiana that contain no acute care hospital.2 acute care is defined as medical treatment of a severe and short-lasting injury or disease. 3 acute care hospitals generally provide many important medical services consisting of inpatient and outpatient treatments. most of the counties that lack an acute care facility are found south of indianapolis or in what may be considered southern indiana. 4 southern indiana has historically faced greater economic hardship than other regions of the state. 5 as of 2000, eighteen of indiana's poorest thirty counties were located in southern indiana.6 moreover, the real per capita personal income of twenty-seven indiana counties, fifteen of which are found south of indianapolis, are at least 25 percent 1 terrell zollinger et al., ind. univ. ctr. for health policy, critical shortage of physicians and nurses projected for indiana 4 (marilyn yurk ed., 2008), available at http://www.healthpolicy.iupui.edul pubspdfs/critical%20shortage%200f%20physicians%20and%2onurses.pdf. 2 affiliated serv. providers of ind., inc., ind. state dep't of health, indiana state rural health plan 35 (2011), available at http://www.in.gov/isdhlfiles/indianastateruralhealthplan2o1lfinal.pdf. 3 merriam-webster, medical dictionary (2012), available at http://www.merriam-webster.com/medicallacute%20care (last visited nov. 23, 2012). 4 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 35. 5 scott macgregor, much oflndiana faces more bhght than bloom: metro area's economic upsurge hasn't fanned outward, indianapolis star, may 15, 2002, at al. 6 id. 834 vol. 11:2 medical care in rural indiana below the national personal income average. 7 the disproportionate regional distribution of acute care hospitals reflects the disparate distribution of wealth within the state. based on these facts, it may be that southern indiana counties are fiscally incapable of establishing public hospitals. specifically, the poor economic state of these counties most likely severely weakens the taxation pool on which county governments must rely to establish and maintain public institutions. at the same time, it seems that the private sector has refused to invest in the povertystricken counties for want of an economic incentive. the nonexistence of acute care hospitals within certain indiana counties has the potential to produce devastating results in the context of individual life and also in the wellbeing of the population of those counties. for example, if an individual finds himself severely injured within a county that is without an acute care provider, say in a car accident on the back-roads of crawford county8 , then he must seek treatment in a nearby county. in some accident scenarios, undoubtedly time is of the essence and failure to speedily obtain treatment could result in loss of life or permanent disability. even more striking, it would take at least sixty minutes to reach a level 1-3 trauma center in 8.18 percent of the total geography of indiana. 9 and while 8.18 percent seems insignificant, and it would be in most non-life threatening instances, it is staggering in the context of a life-threatening injury. however, some might argue that such a small percentage (8.18%) of the state, where medical response time is delayed, is confined and affects only a small amount of people. this assertion fails to consider the mobility of the population; in-state and out-of-state travelers, commercial or not, frequently must move across these areas of delayed 7 morton j. marcus, the rich stay rich among indiana s counties, ind. bus. rev., fall 2000, at 1, available at http://www.ibrc.indiana.edu/ ibr/2000/fall00/01.pdf. 8 crawford county is located in south central indiana along the ohio river. 9 univ. of pa., indiana: trauma center lv 1-3 access 2010, traumamaps.org, http://www.traumamaps.org/trauma.aspx (last visited nov. 22, 2012). 2014 835 indiana health law review response, which augments the at-risk population. the existence of these delayed response areas is indicative of the need for the construction of new hospitals. failure to invest in the construction of these hospitals will necessarily result in the continued unreasonable exposure of certain populations, residents and passersby, to a risk of untimely treatment, which could produce negative consequences such as prolonged recovery or sometimes even death. hospitals, besides providing general medical care, also offer many specialty services which range from cardiologic to podiatric services. the importance of certain specialties cannot be overstated. specialists provide an expertise in the diagnosis and treatment of complex ailments and conditions that cannot be matched in general medicine. obstetrics is one of these expert fields and it is a staple in the maintenance of women's overall health. specifically, obstetrics is a field of medicine that pertains to pregnancy and childbirth.' 0 despite its major importance to such a numerous class, there are twelve indiana counties that have no obstetrical services available. 11 the potential consequence of this dearth of obstetrical services in certain indiana counties is palpable and appalling. statistics are incapable of illustrating the disturbing adverse effects of the absence of obstetrical services in these counties. hypothetically, due to the lack of obstetrical services, a pregnant woman residing in crawford county for example, who begins labor, would be required to travel to a neighboring county to receive medical assistance. under these pressing circumstances, it is plausible that the woman could be forced to give birth without assistance, possibly endangering the welfare of both mother and child. some might rightly posit that the above example is conjecturally anecdotal and maybe even extreme. however, it must be remembered that effective legal systems do not only concern themselves with merely remedying definable and 10 merriam-webster, medical dictionary (2012), available at http://www.merriam-webster.com/medicallobstetrics (last visited nov. 23, 2012). 11 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 35. vol. 11:2836 medical care in rural indiana empirically proven problems and imperfections. an effective legal system takes into account potential consequences of an imperfect arrangement of variables, and it intuitively and prophylactically implements measures that reduce or eliminate those consequences. given the current preeminent state of technology and the economic powerhouse status of the united states, it is unthinkable and deplorable that such a set of conditions exists that could lead to a deprivation of medical assistance to such a large class of persons. b. medically underserved areas and populations in indiana the health resources and services administration (hrsa) is an agency within the u.s. department of health and human services.12 the health resources and services administration is responsible for facilitating greater access to health care for underserved populations and suspect classes. 13 at the time of writing this note, according to the hrsa, there are fifty-four medically underserved areas in indiana.14 a medically underserved area is one which lacks adequate personal health services given the population.' 5 medically underserved areas are designated by county, a group of contiguous counties, or in cities by census tracts which are comprised of like economic and demographic characteristics.1 6 also according to hrsa, there are twenty12 u.s. printing office, the united states government manual (2012), available at http://www.usgovernmentmanual.gov/ agency.aspx?entityld=ldrc/ujfjeo=&parenteld=+klubnxgvoo&etype-j y3m4ctkvhy=. 13 id 14 health res. & servs. adin., u.s. dep't of health & human servs., medically underserved areas/populations (mua/p): state summary of designated mua/p 1 (2012), available at http://datawarehouse.hrsa.gov/topics/shortageareas.aspx. 15 health res. & servs. admin., u.s. dep't of health & human servs., shortage designation: health professional shortage areas & medically underserved areas/populations, bhpr.hrsa.gov, http://www.hrsa.gov/ shortage/ (last visited nov. 23, 2012). 16 health res. & servs. admin., u.s. dep't of health & human servs., medically underserved areas/populations: guidelines for mua and mljp 2014 837 indiana health law review four medically underserved populations within indiana. 17 the distinguishing characteristic between medically underserved areas and populations is that the designation of medically underserved populations is focused more narrowly on a demographic group which is impaired from obtaining primary medical services due to economic, cultural, or linguistic misfortunes.' 8 there are several factors that are applied to determine whether a particular area or population qualifies as medically underserved. these factors include the "ratio of primary care physicians to the population, infant mortality rate, percentage of the population which is age 65 or older, and percentage of the population with family income below the poverty level."' 9 based on the severity of these factors, a score is computed for an area. the score for an area is then measured against the national median score, which lies on a scale of 1-100. a score of zero is the lowest possible medically underserved score, and 100 is the highest and best medically served score. if the overall score for a particular area falls below the national median score of sixty-two, then the area is considered medically underserved. 20 despite the failure of certain areas to qualify for the designation of medical underservice, the governor may request that those areas receive the designation due to exceptional circumstances. 21 according to the hrsa, nineteen areas or populations have received this special type of governor designation. 22 in all, a combination of designation, bhpr.hrsa.gov, http://www.hrsa.gov/shortage/ mualindex.html (last updated june, 1995). 17 health res. & servs. advin., u.s. dep't of health & human servs., supra note 14. 18 health res. & servs. admin., u.s. dep't of health & human servs., supra note 15. 19 medically underserved areas and population groups, 41 fed. reg. 45718 (oct. 15, 1976) (codified at 42 c.f.r. § 51c.102(e)(1-4) (2013)). 20 health res. & servs. admin., u.s. dep't of health & human servs., supra note 16. 21 id. 22 health res. & servs. admin., u.s. dep't of health & human servs., state profile: indiana: state in hhs region v 8 (2012), available at http://datawarehouse.hrsa.govhgdwreports/ rt.app.aspx?rpt= sp . 838 vol. 11:2 medical care in rural indiana ninety-seven medically underserved areas and populations exist in indiana.230verall, rural areas and inner cities are more likely to suffer from medical underservice. 24 c. health professional shortage areas many areas and population groups in indiana particularly suffer a shortage of primary care health professionals. the hrsa is also required to designate areas where there is a shortage of health professionals. the health professional shortage area (hpsa) classification contains three fields or services of health care. these are primary care, dental care, and mental health care. 25 additionally, within the primary care hpsa label, there are three distinct subcategory designations which include geographic area (which has a shortage of health professionals), population group, and facility.26 for each of these subcategories of the hpsa designation, there are established criteria which must be satisfied in order that the hpsa designation attach.27 for example, in order for a geographic area to qualify for designation as a primary care health professional shortage area, the geographic area must: be an area where it is logical to provide primary care services, show that the ratio of the area's population to full time primary care physicians is not lower than 3,500 to 1 or not less than 3,000 to 1 if the area displays a uniquely high demand for primary care physicians or an "insufficient capacity of existing primary care providers," and show that primary care physicians in surrounding areas are overworked, far removed, or unable to be reached by the 23 id. 24 zollinger et al., supra note 1. 25 health res. & servs. admin., u.s. dep't of health and human servs., shortage designation: health professional shortage areas (hpsas): designation criteria and guidelines, bhpr.hrsa.gov, http://bhpr.hrsa.gov/ shortage/hpsas/designationcriterialindex.html (last visited nov. 23, 2012). 26 health res. & servs. admin., u.s. dep't of health and human servs., shortage designation: primary medical care hpsa designation overview, bhpr.hrsa.gov, http://bhpr.hrsa.gov/shortage/hpsas/designation criterialprimarycarehpsaoverview.html (last visited nov. 23, 2012). 27 id 2014 839 indiana health law review population of the area. 28 for each criteria listed above, there are guidelines which are determinative of whether the geographic area meets the relevant criterion. for example, one guideline for determining whether a geographic area, which has a population to primary care physicians ratio of more than 3,000 to 1 but less than 3,500 to 1, displays a uniquely high demand for primary care physicians, is that the area suffers an infant death rate of more than 20 per 1,000 births. 29 as of 2012, indiana has received 104 total designations of primary care health professional shortage areas. 30 indiana fairs better than four out of five states listed in its region in regard to the total amount of primary care designations. 31 however, indiana falls behind only illinois in having the greatest number of counties to receive the primary care hpsa designation within its region. 32 as of november 27th, 2012, 1,107, 243 hoosiers live in or are a part of an area, population, or facility which suffers a shortage of primary care health professionals. 33 in indiana's region and as of november 27th, 2012, only ohio, illinois, and michigan have more residents who are living in or are a part of an area, population, or facility which suffers a shortage of primary care health professionals. 34 on average, there are 53.6 primary care physicians per 100,000 hoosiers. 35 the national average amounts to 90.5 28 id.; criteria for designation of areas having shortages of primary medical care professional(s), 42 c.f.r. pt. 5, app. a. (2012). 29 42 c.f.r. pt. 5, app. a. part i(b)(4)(b). 30 health res. & servs. admiin., u.s. dep't of health & human servs., supra note 22, at 9. 31 bureau of clincian recruitment & serv., u.s. dep't of health & human servs., designated health professional shortage areas (hpsa) statistics: primary care 2 (2012). there are five other states in indiana's region. id. 3 2 id s id. 34 id. 35 hannah maxey et al., ind. univ. ctr. for health policy, indiana primary health care: description, distribution, challenges, & strategic recommendation to empowered decision maeing 6 (2012), available at http://www.ic4n.org/wp-content/uploads/2013/03/indianaprimary-health-care.pdf. 840 vol. 11:2 medical care in rural indiana primary care physicians per 100,000. indiana's ratio of primary care physicians per 100,000 is 40 percent below the national average. 36 non-metropolitan indiana counties suffer more acutely from this shortage of primary care physicians as they generally have less primary care physicians per the population than metropolitan counties have. 37 specifically, 98 percent of rural counties in indiana are deficient in primary care specialists, and thus they do not satisfy the u.s. standard ratio of primary care specialists per 100,000. 38 in order to adequately fulfill demand for medical services throughout the state, 5,000 more physicians need to be injected into the workforce.39 in sum, indiana falls behind thirty-four states in the accessibility of physicians who provide primary care. 40 part ii a. medical malpractice and its effects medical errors and the litigation that flows from them have burdened the healthcare industry in the past. 41 the severe and increasing costs of malpractice litigation continue today to plague the healthcare industry. 42 also, medical professionals' perception of a litigious consumer base and legal favoritism to these consumers' cause is remarkably apparent. 43 in the context of rural practice then, the question becomes whether the variables and unique set of conditions of rural practice influence and 36 id. 37 zollinger et al., supra note 1, at 7. 38 id. at 1. 39 id. 40 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 8. 41 alec shelby bayer, looking beyond the easy fix and delving into the roots of the real medical malpractice crisis, 5 hous. j. health l. & pol'y 111, 115-16 (2005). 42 id. at 114-15. 43 see id. at 116; alan g. williams, the cure for what ails: a reahstic remedy for the medical malpractice "crisis" 23 stan. l. & pol'y rev. 477, 487 (2012). 8412014 indiana health law review exacerbate medical professionals' perception and fear of malpractice litigation, resulting in a greater disincentive to practice there. 44 in 2002, one-third of u.s. hospitals experienced a 100 percent increase in medical liability insurance premiums. 45 it is also reported that in response to rising liability premiums, 25 percent of u.s. hospitals have reduced the extent to which they provide or have altogether terminated certain medical services. 46 the rising costs of malpractice litigation have also negatively affected the ability of some all-important trauma centers to feasibly remain in operation.47 additionally due to rising premiums, in some states physicians have closed their doors and moved in search of a more legally favorable place to practice. 48 moreover, some physicians have summarily ended their careers in medicine due to the high costs of malpractice litigation. 49 in 2011, 167 medical malpractice claims resulted in payment in indiana.5 0 these payments amounted to $ 22, 473, 800.51 the payments however do not reflect the total costs of malpractice litigation. defendant physicians or their insurers must also bear the costs of attorney's and expert witness' fees and other transactional costs in preparing for litigation and in defending against malpractice claims. even defendant physicians who are not found to be liable still incur some litigation costs. insurance companies in turn spread these costs across the profession sometimes resulting in higher premiums. as a consequence 44 see williams, supra note 43, at 490. 45 addressing the new health care crisis: reforming the medical litigation system to improve the quality of health care hearing before the s subcomm. on labor, health and human serv. and educ. of the s appropriations comm., 108th cong. (2003) (statement of claude a. allen, deputy sec'y of the dep't of health and human servs.). 46 id. 47 id. 48 id. 49 id. 5o kaiser family found., state health facts: indiana: number of paid medical malpractice claims (2011). 51 kaiser family found., state health facts: indiana: payments on medical malpractice claims (2011). 842 vol. 11:2 medical care in rural indiana of rising premiums, hospitals and physicians raise the price of their services, and ultimately patients or their medical insurers bear the extra costs of far removed malpractice litigation. the indiana legislature enacted the medical malpractice act to combat the increasing cost of malpractice litigation on the medical field.5 2 the malpractice act created a process whereby malpractice claims are submitted to a board of three medical practitioners and a single practicing attorney who oversees the board's legal analysis of each malpractice claim.53 the board of physicians makes a legal determination on each claim of whether the physician in question breached the standard of care. 54 the board's finding in favor of the physician becomes a de facto summary judgment motion in subsequent litigation. 55 additionally, although indiana is a comparative fault jurisdiction, contributory negligence on the part of the patient is a complete bar to recovery in malpractice litigation.56 b. the conception and history of the locality rule the locality rule in the united states owes its existence to the kansas supreme court, which purportedly first adopted the rule in 1870. 57 in the late nineteenth century and before the landmark case of tefft v. wilcox, physicians and surgeons in kansas were required to exercise that level of ordinary care and skill and to possess that level of knowledge which experts in the field of medicine had 52 bruce d. jones, unfair and harsh results of contributory neghgence lives in indana: the indiana medical malpractice system and the indiana comparative fault act, 6 ind. health l. rev. 107, 109-12 (2009). 53 ind. code §§ 34-18-8-4, 34-18-10-1, 3, 19 (2012). 54 § 34-18-8-4. 55 snyder v. cobb, 638 n.e.2d 442, 447 (ind. ct. app. 1994). 56 ind. code § 34-51-2-1(b)(1) (2012). 57 brent r. cohen, the locality rule in colorado: updating the standard of care, 51 u. colo. l. rev. 587, 588 (1980) (exploring the history of the locality rule). 2014 843 indiana health law review espoused and which the profession commonly accepted. 58 tort law at that time thus pronounced the expectation that the skill and expertise of physicians practicing in smaller towns should be of the same quality and nature as the skill and expertise of physicians working in cities.5 9 liability then could be established merely by a showing that a defendant physician's conduct deviated from the commonly accepted mode of treatment, with no attention or analysis being paid to the circumstances and conditions of a particular locale.60 in tefft, plaintiff wilcox brought suit alleging that the defendant physician's treatment of his arm caused him to lose the use of it and his shoulder.6 1 principally, the kansas supreme court focused their inquiry on evidentiary and jury instruction error. 62 however, the court clarified the standard of care for physicians practicing in kansas. in examining circumstances that may affect a physician's ability to comport his skill and knowledge to the established standards of the profession, the kansas supreme court noted that locality of practice constituted an extenuating circumstance of potential permissible deviation.6 3 the court explained that physicians practicing in larger cities usually possessed greater knowledge and skill in medicine, were endowed with better medical facilities, and had more exposure to routine operations and varying maladies. 64 the court reasoned that, due to the fact that physicians practicing in small towns had less access to comprehensive facilities and less experience treating diseases, physicians in smaller towns or in rural areas should be held to a lower standard of care and skill than those physicians operating in cities were held. 65 presumably then, locality with its attendant unique 58 see tefft v. wilcox, 6 kan. 46, 62 (1870) (quoting elwell on malpractice). 59 see id. 60 see id. 61 id. at 54 (quoting elwell on malpractice). 62 id. at 60 (quoting elwell on malpractice). 63 id. at 63 (quoting elwell on malpractice). 64 id. at 63-64 (quoting elwell on malpractice). 65 id. (quoting elwell on malpractice). 844 vol. 11:2 medical care in ruiral indiana conditions would from then onward be instrumental in defining the contours of a physician's standard of care. c. the modified locality rule debuts in indiana jurisprudence in 1877, the indiana supreme court in gramm v. boener held that the trial court did not err in refusing to include an instruction to the jury that emphasized strict locality as the applicable standard of care for physician liability.66 plaintiff boener brought suit alleging that the defendant physician gramm improperly and ineffectively realigned his broken arm and leg which caused a loss of the use of his arm and a deformity in his leg. 67 upon review of the jury instruction, the court ruled that the doctrine of strict locality, which required physicians to only exercise that level of ordinary care and skill that was established in their particular community, was not the applicable law in the state. 68 the gramm court reasoned that it was an unthinkable proposition to allow a handful of physicians in a rural community to dictate the standard of care to which they would be held, because quite poignantly some physicians might be incompetent and others could be phonies of the profession. 69 quite obviously then, the gramm court's motivation for uprooting the strict locality rule was founded upon the possibility that pockets of the profession could essentially and unfairly shield themselves from liability. the new rule then would seek to pierce the so-called shield of malpractice protection. the gramm court ultimately laid down what is known as the modified locality rule. 70 this new version of the doctrine of locality required physicians to 66 gramm v. boener, 56 ind. 497, 500-01 (1877). 67 id. at 497. 68 id. at 500. 69 id. at 501 ('there might be but few practising in the given locality, all of whom might be quacks, ignorant pretenders to knowledge not possessed by them, and it would not do to say, that, because one possessed and exercised as much skill as the others, he could not be chargeable with the want of reasonable skill."). 70 id 2014 845 indiana health law review exercise that level of care and skill that ordinarily careful and skillful physicians of similar localities exercised.71 this slight modification of the locality rule meant that physicians facing malpractice liability could no longer only show, and hence rely on the fact, that their professional conduct comported with the normative conduct of their colleagues practicing in the same town. hence, the modified locality rule seemingly expanded the scope of inquiry into the established standard of care from a single town perspective to a collective perspective of many towns similarly comprised and situated. one hundred years later, in wilson v. sligar, the indiana court of appeals held that the trial court erred in refusing to allow the plaintiff wilson to establish, through expert witness testimony, the national minimum standard of care for orthopedic surgeons because such testimony was permissibly intended to illustrate the nature and wide scope of locality applicable to the facts therein.72 plaintiff wilson sought treatment for a discomfort in her hip, which a surgeon had already operated on in recourse to an injury sustained in a car accident, from defendant sligar who was an orthopedic surgeon. 73 doctor sligar performed noninvasive methods of remediation, but those efforts failed to alleviate wilson's suffering. 74 after further examination of wilson, doctor sligar informed her that a total hip replacement would be necessary. 75 however after consummation of the surgery, plaintiff wilson developed a neurological condition called foot drop. 76 subsequently, doctor sligar applied remedial measures to improve the condition, and he counseled that additional surgery was required.77 plaintiff wilson however rejected the prospect of dr. sligar performing the surgery.78 wilson's surgery to 71 id. 72 wilson v. sligar, 516 n.e.2d 1099, 1102-03 (ind. ct. app. 1987). 73 id. at 1100. 74 id. 75 i~d. 76 id. 77 id. 78 id vol. 11:2846 medical care in rural indiana correct the foot drop was performed by two other surgeons. 79 while performing the surgery, the surgeons noticed some damage to the sciatic nerve and the surgeons came to the conclusion that the damage was a consequence of a retractor applied during doctor sligar's hip replacement surgery.8 0 the plaintiff brought suit alleging negligence on the part of doctor sligar in the performance of the hip surgery.8 1 in ruling on the trial court's refusal to admit evidence establishing the national minimum standard of care for orthopedic surgeons, the sligar court explained that the strict locality rule was premised upon avoiding the unfairness of attaching malpractice liability to rural physicians for conditions outside of their control; the court noted that these historic conditions constituted the difficulties of travel and urban physicians' greater access to education, better medical facilities, and skills training through practice. 82 the court noted that advancements in mobility, increased access to education, equal quality of medical facilities and equipment, and better avenues of acquiring knowledge had seriously weakened the need and usefulness of the strict locality rule. 8 3 ultimately, the sligar court ruled that the plaintiffs questioning of expert witnesses to establish a national minimum standard of care was permissible because the plaintiff sought to lay a requisite foundation for the testimony.84 however, the court ruled that the plaintiff failed to show that the trial court's refusal to admit the testimony amounted to reversible error.85 the sligar court's holding is illustrative of a judicial recognition at the time that national minimum standards of care existed and that these minimum standards were relevant in establishing the scope of locality. specifically, 80 id 81 id 82 id at 1101. 83 id 84 id. at 1102. 85 id. at 1103. 2014 847 indiana health law review this recognition implied that the standard of care established in similar localities did not in fact control in exclusively setting the threshold of liability. contrarily, the sligar court's holding stood for the proposition that national minimum standards of care could, in certain cases, trump any pertinent standard established in similar locales. therefore with the expansion of locality, a defendant physician could no longer solely rely on the fact that her performance was in line with established standards of care in similar locales to avoid liability if it could be shown that national minimum standards existed and the physician's performance failed to meet these standards. just five years after sligar, the indiana supreme court altogether abandoned the modified locality rule in vergara v. doan.86 plaintiff vergaras' son allegedly was injured by the defendant physician's negligent performance of their son's delivery.87 the plaintiffs sought appeal after a jury returned a verdict in favor of dr. doan, and the court of appeals affirmed.88 on appeal to the indiana supreme court, the plaintiffs argued that the modified locality rule should be abandoned in indiana.89 the court agreed with plaintiffs and ruled that, "a physician must exercise that degree of care, skill, and proficiency exercised by reasonably careful, skillful, and prudent practitioners in the same class to which he belongs, acting under the same or similar circumstances."9o the vergara court echoed the court of appeals in sliger on the reasons for the modern day irrelevance of the locality rule. the court observed that advancements in mobility, communications, and increased access to medical education served to vitiate the foundation for applying the locality rule. 91 the court however did not completely eradicate locality from the standard of care for physicians. the court 86 vergara v. doan, 593 n.e.2d 185, 187 (ind. 1992) (adopting a national standard of care for physicians). 87 id. at 186. 88 id 89 id. at 187 (plaintiffs argued that the justifications for the modified locality rule were hollow in the current age). 9 0 id. 91 id. 848 vol. 11:2 medical care in rural indiana explained that locality would no longer be determinative in setting the parameters of the standard of care for physicians. 92 instead, locality would be a factor among others in determining whether the physician complied with the standard of care. 93 in ruling on the reversibility of error, the court held that the lower court's instruction to the jury which emphasized the standard of care of a similar community was harmless error, because an additional instruction informed the jury that the defendant's performance could be held to a national minimum standard of care for his specialty if the evidence sufficiently established such standard.94 the vergara decision represents a legal evolution and response to a culmination of a century long progression in technology and medicine. it is unquestionable that the past century has been marked by riveting breakthroughs in medicine, and it is equally apparent that advancements in communication and travel have helped to widely diffuse these developments to a significant percentage of the population. however, the vergara decision presupposes that this progression has led to equality in the platforms for and nature of delivering medical services. specifically, the court overlooked conditions of rural locales such as high patient-to-doctor ratios, overworked physicians, and subpar medical facilities and equipment. d. the modified locality rule as a solution to inaccessibility there is much valid criticism of the locality and the modified locality rule. critics of the rule argue that unlike today, there was much variation in the standards taught at medical schools in the nineteenth century.95 they also point out that metropolitan physicians in the nineteenth century, 92 id 9 id 94 id at 8. 95 see samuel j. stoia, vergara v. doan: modern medical technology consumes the locality rule, 2 j. pharmacy & l. 107, 108-09 (1993). 2014 849 indiana health law review unlike their rural counterparts at that time, had routine and better access to varying diseases and ailments of which they could gain greater knowledge and expertise through practice and treatment. 96 also, critics rightly posit that impairments of the diffusion of medical knowledge, such as inefficient means of travel and lack of viable forms of communication, do not exist today as they did in the nineteenth century. 97 additionally, those critics suggest that advancements in communications allow rural physicians today to remain up to date in their knowledge of ailments and treatments. 98 however, there might be persisting conditions today, which the critics of the rule underestimate, that give life to the rule.99 fairness still lies at the heart of the justification for application of the modified locality rule, as it did over one hundred years ago. nineteenth century courts recognized that conditions outside the control of physicians in a particular area profoundly affected the quality of performance in the delivery of medical care, and those courts in response rightly crafted a lenient rule with a focus on mitigating the harshness of liability in the absence of true fault while providing recourse for those defendants injured due to inexcusable fault. it is true today that some conditions of the nineteenth century, which were cited by courts to highlight the unfairness of an inflexible rule of malpractice liability, have improved. despite the fact that some reasons for the modified locality rule have waned, it does not follow that a fairness inquiry is completely undermined or inappropriate. fairness still today remains a viable concern in analyzing the national standard of care rule and its application because of its historical role in 96 compare wilson v. sligar, 516 n.e.2d 1099, 1101 (ind. ct. app. 1987), with tefft v. wilcox, 6 kan. 46, 63-64 (1870) (quoting elwell on malpractice). 97 see scott a. behrens, call in houdini: the time has come to be released from the geographic straitjacket known as the locality rule, 56 drake l. rev. 753, 762 (2008);cohen, supra note 57, at 595. 98 behrens, supra note 97, at 763. 99 henry c. karlson & roger d. erwin, medical malpractice: informed consent to the localty rule, 12 ind. l. rev. 653, 665-66 (1979) (quoting william kane, rural health care, 240 j. am. med. ass'n. 2647 (1978)). 850 vol. 11:2 medical care in rural indiana shaping the particular rule at hand and also due to its foundational character in the anglo-american legal system. under this legal framework then, applying the national standard of care to rural physicians might be unfair due to the potential existence of conditions outside the control of rural physicians.100 specifically, holding rural physicians to the same standard of care as metropolitan physicians is inequitable if metropolitan physicians have access to better medical facilities.10 1 also, applying the national standard of care to rural physicians is inequitable if physicians practicing in larger cities have better access to more effective and safer medical technologies. applying the national standard of care to rural physicians is unfair if rural physicians work longer hours or service more patients per physician than metropolitan physicians do. in fact, rural physicians on average work more hours and service more patients than metropolitan physicians do.102 it could be then that the amount of time that a rural physician allocates per patient is more limited and shorter than the amount of time that a metropolitan physician allocates per patient due to the greater number of patients that a rural physician services. if this is true, then rural physicians are most likely exposed to a greater risk of misdiagnosis or inadequate treatment due to having less time to commit per patient. for example, a rural physician may find it necessary to speed the process of a particular patient visit in order to perform check-ups and treat as many rural patients as he is expected. this could result in the rural physician failing to notice a symptom of an underlying disease whereas a metropolitan physician would discover the symptom due to having more time to commit to the particular patient. consequentially, the patient then might bring suit against the rural physician under a theory 100 see id. at 663, 665-66. 101 see id. at 666 (arguing that it would be unfair to hold rural physicians to a higher standard of care if differences in the standard of care between rural and non-rural communities exist). 102 david a. matsa, does malpractice liability keep the doctor away? evidence from tort reform damage caps, 36 j. legal stud. s143, s168 (2007). 2014 851 indiana health law review of negligent inspection and failure to diagnose. if the national standard of care is applied in lieu of the modified locality rule in this instance, then it is almost certain that the plaintiff would seek to show that the rural physician's shorter duration of inspection of the plaintiff breached the customary standard of time for inspection as established by physicians practicing in city hospitals. holding rural physicians to this metropolitan standard would be unfair because the shortage of health professionals in rural areas virtually requires rural physicians to see more patients and consequentially stretches the physicians' performance capacity. moreover, in order to comply with this urban standard, rural physicians would most likely receive fewer patients per day, and in turn this would worsen the state of inaccessibility of medical care in rural areas. however, even if rural physicians are able to spend on average the same amount of time per patient as metropolitan physicians spend, it still remains that rural physicians work more hours per week than metropolitan physicians. working longer hours while treating more patients might place a heavier strain on rural physicians that could result in more professional mistakes being made. this should not imply that stress and strain due to over exertion are per se justifications for denying recovery in a malpractice action. however, the establishment of the standard of care in this instance based on the work place customs of metropolitan physicians could set the expectation of conduct at an unattainable level for rural physicians. in other words, the unique circumstances of rural practice may, to an extent, undermine or even thwart compliance with a standard based on urban custom. adjusting to this metropolitan standard could require rural physicians to work less hours thereby resulting in a decrease in the number of patients treated. as a matter of public policy, this is untenable due to the existing medical underservice of rural areas in indiana. although indiana has enacted pro-physician medical malpractice legislation, the modified locality rule would particularly provide an incentive for physicians to practice in rural areas. physicians, in deliberating about where to 852 vol. 11:2 medical care in rural indiana establish a practice, most likely base their decision on rational considerations. arguably, their decision to practice in a city, in the suburbs, or in the country is largely reached through a cost-benefit analysis. some of these direct costbenefit factors are the amount of compensation, the amount of work hours, the nature and extent of opportunities for professional growth, the nature of the local market, and the nature of legal regimes. comprehensive risk assessment then is invaluable to their ultimate decision. in reaching this professional decision, the fact that the law will impose upon a physician practicing in a rural area the performance expectations of metropolitan physicians, who might have access to better medical facilities, expensive and advanced medical technologies, and more time to devote to each patient, will be a disincentive for the physician to choose to engage in rural practice. the application of the modified locality rule might allow rural physicians to sometimes escape malpractice liability, where under the national standard of care they would otherwise be held liable, and this safety net could potentially curb the cost of maintaining a viable rural practice. therefore, the lowered costs of practicing in a rural area might entice physicians to begin or continue practicing there. research suggests that statutory caps on non-economic damages in malpractice suits have increased physician supply in rural areas. an analysis of the effects of damage caps by matsa shows that caps do not increase physician supply on a statewide level, but they increase physician supply in the "most rural areas" by 3-5 percent.103 moreover, matsa concludes that caps on damages particularly increase the supply of surgical specialists and supporting specialists in the "most rural areas."104 his report indicates that the caps increase surgical specialists by 10 percent and supporting specialists by 12 percent in "most rural areas," respectively. 105 103 id. at s162. 104 id. at s165. 105 id. 2014 853 indiana health law review application of the modified locality rule has the potential to effectuate an even greater increase in the supply of rural physicians. the modified locality rule, unlike damage caps, affects the determination of liability. in essence then, the modified locality rule with its narrower reach of liability may decrease the amount of successful claims of malpractice. a statutory cap on damages however is not determinative in a finding of liability and does not limit the amount of successful malpractice claims. thus, the application of the modified locality rule would altogether eliminate litigation costs (e.g. a judgment) in a given case, whereas liability would not be avoided in the context of a cap on damages and a consequential award for the defendant would only be decreased to the extent of noneconomic damages. if damage caps increase physician supply in rural areas by lowering malpractice litigation costs, then it follows that another legal remedy which entirely eliminates litigation costs could be just as and possibly even more effective in creating a higher supply of rural physicians. however this assertion presumes that the application of modified locality rule would be just as reliable in reducing malpractice costs as a mandated cap on damages. notwithstanding this assumption, the modified locality rule should be considered in the adoption of judicial solutions to combat the inaccessibility of medical care due to its potential to create fairness in malpractice litigation and to make rural practice an attractive and enjoyable endeavor. however, if the critics of the modified locality rule are correct in their argument that the need for the modified locality rule has completely disappeared, then other judicial means of combating the inaccessibility of medical care in rural areas are necessary. the application of gross negligence as the standard of medical malpractice liability for rural physicians may serve as a potential remedy for the inaccessibility to medical care. 854 vol. 11:2 medical care in rural indiana e. gross negligence as a solution to inaccessibility an alternative to implementing and applying the modified locality rule to physicians practicing in rural areas is the adoption of gross negligence as the threshold of medical malpractice liability for rural physicians. adoption of the gross negligence standard might act as an incentive for physicians to practice in rural areas due to its potential effect of decreasing the cost of malpractice liability. the implementation of gross negligence rests almost solely on a utilitarian justification, whereas implementation of the modified locality rule is premised largely on fairness with an underlying objective of creating community benefit. the application of gross negligence would directly benefit physicians by providing a degree of immunity while simultaneously it would thwart the interest of an injured patient to receive compensation. however in utilitarian terms, a rural community would benefit overall even at a single patient's loss of compensation because a degree of physician immunity would incentivize rural practice thereby increasing the supply of physicians and creating greater access to healthcare in the community. the adoption of gross negligence has the potential to attract physicians to rural areas. as mentioned above, the costs of malpractice litigation have been staggering and detrimental to the medical field. 106 lowering the cost of malpractice liability by adopting gross negligence as the threshold of liability for rural physicians may have the effect of incentivizing rural medical practice. while the application of a gross negligence standard to the liability of rural physicians may be deemed grossly unfair to patients and even a radical approach, the goal of eradicating the severe inaccessibility of medical care in rural areas is essential, and it most likely outweighs the temporary costs to quality and consequentially the costs to 106 see daniel eisenberg & maggie sieger-joliet, the doctor won't see you now, time, jun. 09, 2003, at 46, available at http://www.time.com/ time/magazine/article/0,9171,1004970-1,00.html (noting, however, that premiums are more affordable in indiana than they are in other highpremium states); williams, supra note 43, at 480-85. 8552014 indiana health law review some unfortunate patients. several societal benefits will materialize due to greater accessibility of medical care. inefficiencies in providing and gaining access to care will most likely be minimized. specifically, transaction costs of patients and physicians such as time and money spent traveling and seeking out medical resources, medical errors in referencing between doctors,10 7 and higher and inflated malpractice premiums will be reduced. also, application of a gross negligence standard would promote redistribution of medical resources to the locales where they are most needed. instead of allocating resources to areas where they will be over consumed, medical resources will be directed to areas and populations where their true market value can be best exploited. also, with increased access to healthcare in rural areas, the overall health of citizens may improve. with an improvement in overall health, productivity in many areas may be bolstered. in sum and as aforementioned, a healthier population will be able to spend more of its resources on commerce, education, and leisure activities that will greatly benefit society in the long run. the indiana legislature has recognized the need to provide physicians in certain circumstances a degree of civil immunity in order to reap overarching societal benefits. one such high-stakes circumstance in which indiana affords great protection to physicians is when they volunteer their expertise and service to clinics and health facilities that do not require payment for medical services. 108 under this circumstance, malpractice liability cannot attach unless the physician's conduct rises to gross negligence.109 civil immunity in this instance is founded upon the public purpose of facilitating greater access to healthcare for the uninsured and other suspect classes, and this purpose overrides the interest of the injured patient to be economically restored. additionally, it seems that the 107 this would most likely be true if physicians of general medicine were able to refer patients to specialists whom they work alongside. this could potentially reduce errors in communicating the medical history and nature of the disease and treatment of patients. 108 ind. code § 34-30-13-1 (2012). 109 id. §§ 34-30-13-1, 2. 856 vol. 11:2 medical care in rural indiana intent of the legislature is two-fold in heightening protection against liability in this circumstance. firstly, the statute intends to reward physicians for acting on behalf of societal interests. in other words, the statute implies that it would be unfair to expose physicians to a liability based on ordinary negligence due to the fact that the physicians' actions are not performed for the sake of self-interest. more importantly however, the statute intends to promote the continuance of philanthropy in healthcare in order to fulfill the public purpose of expanding access to healthcare. indiana courts should be mindful of public purpose and policy and societal interests in fashioning the particulars of a standard of gross negligence. a standard of gross negligence should be formidable in creating greater access to healthcare for rural citizens. at the same time, the standard must contain checks against potential abuses that would undermine its purpose. a standard of gross negligence that leans too far in favor of physician protection would ignore the public's interest in receiving quality healthcare. a standard that provides too little physician protection against liability would make the effectiveness of the standard hollow. against this backdrop of balancing public purpose and policy with other societal interests, indiana courts should promulgate a workable definition and standard of gross negligence to be applied in cases of rural malpractice. northern indiana public service company v. sharp illustrates the current definition of gross negligence in indiana. in sharp, the plaintiff brought suit under a theory of gross negligence in accordance with the indiana civil defense and disaster law of 1975. 110 on appeal, the indiana supreme court reviewed the court of appeals' decision that the defendant electric company did not owe a duty to a truck driver who was electrocuted by a cable that the electric company operated. 111 the indiana supreme court defined gross negligence as, '[a] conscious, voluntary act or omission in reckless disregard of . . . the 110 northern ind. pub. serv. co. v. sharp, 790 n.e.2d 462, 464 (ind. 2003). 111 id. at 464-65. 8572014 indiana health law review consequences to another party."'112 in further defining gross negligence, the issue precisely becomes what constitutes "reckless disregard." the restatement (second) of torts explains that, "in the construction of statutes which specifically refer to gross negligence, that phrase is sometimes construed as equivalent to reckless disregard." 113 further, the restatement defines recklessness as follows, the actor's conduct is in reckless disregard of the safety of another if he does an act or intentionally fails to do an act which it is his duty to the other to do, knowing or having reason to know of facts which would lead a reasonable man to realize, not only that his conduct creates an unreasonable risk of physical harm to another, but also that such risk is substantially greater than that which is necessary to make his conduct negligent.114 in formulating a legal definition and standard of gross negligence, it is imperative to include measures that will uphold society's interests in the reliability and integrity of the healthcare system. particularly, quality should not be so degraded as to make widened accessibility fruitless and meaningless. a recklessness standard of malpractice, as defined by the restatement, for rural physicians is untenable because such a standard would destroy the quality of care provided by rural physicians. this recklessness standard would permit a rural physician's conduct to greatly surpass the conventional negligence threshold without incurring liability unless the risk created by the rural physician's conduct was substantially greater than a risk created by merely negligent conduct. due to the potentially severe adverse effects of the restatement's recklessness standard on the quality of medical care, indiana courts should adopt a definition of 112 id. at 465. 113 restatement (second) of torts § 282 cmt. e(5) (1965). 114 id. § 500. 858 vol. 11:2 medical care in rural indiana recklessness and a standard of gross negligence as follows: gross negligence constitutes a rural physician's conscious failure to conform his conduct to that of a reasonable physician with ordinary skill, knowledge, and expertise, after the rural physician was supplied with facts which would lead a reasonable physician to appreciate the existence of an unjustifiable risk that is moderately greater than a risk that would result in negligent conduct. thus under this standard, a rural physician's conduct can fall below the conduct of a reasonably skillful, knowledgeable, and prudent physician generally without liability attaching. moreover, even if a rural physician's performance falls below the national standard of care and his conduct creates a minimally greater risk than a risk usually resulting in negligence, no liability would attach because the minimally greater risk is not moderately greater. arguably, under a gross negligence approach, the quality of care provided in rural areas would most likely degrade to a certain extent. some physicians might even take advantage of a relaxed standard of care for whatever reason. 115 other rural physicians might unintentionally and subconsciously perform less effectively than they are capable of performing due to the gross negligence standard. of course, some patients, who would normally recover under a medical malpractice claim, would be barred from recovery due to the heightened burden of proving gross negligence. due to moral, utilitarian, and tort policy justifications supporting compensatory recovery by an injured party from a tortfeasor under traditional malpractice liability, some exceptions to the application of gross negligence in the rural medical malpractice context are appropriate. where a patient dies or is severely and permanently injured or disabled by the alleged malpractice of a rural physician, the standard of gross negligence should not apply. in these two instances, it is quite clear that the purpose of increasing the number of physicians in rural areas to augment access to healthcare would be thwarted because rural individuals would be less likely to seek treatment given the increased 115 it is presumed here that physicians are aware of the law and make decisions in light of it. 8592014 indiana health law review severity of potential injury and the absence of stringent legal constraints on rural physicians' conduct. the promotion of greater accessibility to medical care in rural areas outweighs the costs to quality. providing more individuals with access to care is fundamental. temporary costs to quality must be tolerated in order to maximize longterm societal gain. once inaccessibility is eradicated or under appropriate control, then it will be appropriate to slowly remove the restraints on quality which were originally necessary to augment accessibility. thereafter, it will be advisable to focus more resources towards improving quality of medical service in rural areas. part iii a. existing accessibility programs the federal government has created programs to address the inaccessibility of medical care in rural areas. these include physician scholarship and loan repayment programs, rural health clinical programs, medicare payment programs, a j-1 visa waiver for physicians, and federally qualified health center funding.116 the state of indiana must take advantage of these programs in order to address the demand for physicians in rural areas. without sustained reliance on these federal programs, state initiated alternatives will most likely lack adequate force in remedying the disparate allocation of medical resources. some of these programs will be described below. the public health and services act establishes funding for federally qualified health centers.117 under the act, qualified entities may receive grants to "plan and develop health centers which will serve medically underserved populations." 118 additionally, grants may be awarded to 116 ind. state dep't of health, health professional shortage areas, in.gov, http://www.in.gov/isdh/23471.htm (last visited oct. 14, 2013). 117 health res. & servs. admin., u.s. dep't of health and human servs., about health centers: what is a health center? hrsa.gov, http://bphc.hrsa.gov/about/ (last visited oct. 14, 2013). 118 42 u.s.c. § 254b(c)(1)(a) (2012). 860 vol. 11:2 imedical care in rural indiana health centers to "enable the centers to plan and develop a managed care network or plan . . ." and to "plan and develop practice management networks."119 importantly as well, grants are available to the health centers to aid in meeting operating costs. 120 in order receive the grants above, the entity must be either public or non-profit private and provide primary care and additional services to a medically underserved population. 121 under the j-1 visa waiver program, the indiana state department of health is permitted to submit recommendations to the bureau of citizenship and immigration service of the u.s. department of homeland security for the approval of a waiver for recent foreign graduates of medicine.122 without this waiver, fresh foreign graduates are required to return to their home countries for two years.123 the indiana state department of health may submit approval recommendations for thirty foreign physicians per year. 124 in order to qualify for approval of the waiver, foreign physicians must be willing to practice in a primary care health professional shortage or a medically underserved area or population and practice there for at least three years. 125 this program is engineered to retain foreign physicians in order to fulfill the need for medical professionals. under the state loan repayment program, the federal government provides funding to state governmental agencies to repay student loan obligations of primary care 119 id. § 254b(c)(1)(b)-(c). 120 id. § 254b(e)(1)(a). 121 id. §254b(a)(1)(a)-(b),(c)(1)(a),(e)(1)(a). 122 ind. state dep't of health, programs using shortage desipnations: indiana j-1 visa waiver program guidelines, in.gov, http://www.in.gov/isdh/files/inj-1programguidlines_2012-13d(1).pdf (last visited oct. 27 , 2013). 123 ind. state dep't of health, 1ograms using shortage desgnations, in.gov, http://www.in.gov/isdhl24409.htm (last visited oct. 27, 2013). 124 id. 125 ind. state dep't of health, supra note 122, at 1-2. there are additional requirements that the medical employer must meet. one such requirement makes approval of the waiver conditioned upon the medical employer being able to show that it has attempted to hire a u.s. citizen for the position. id. at 2. 2014 861 indiana health law review physicians who agree to work in health professional shortage areas. 126 however, for a state to take part in the program, it must promise to match each dollar of federal funding. 127 primary care physicians participating in the loan repayment program must agree to work for a public or non-profit entity that provides medical services in a health professional shortage area. 128 currently, indiana has halted its involvement in the state loan repayment program because it is unable to provide the necessary state funding.129 while indiana funds community health centers, these centers are an inadequate means of addressing the disparity of access to healthcare. in indiana, there exist forty-eight community health centers. of the forty-eight community health centers, nineteen are classified as federally qualified health centers.130the state of indiana finances these community health centers through an established tobacco settlement fund.1'1 in order to receive funding as a community health center, the facility must provide primary care services for at least twenty hours per week. 132 while this particular prerequisite to funding is not indicative of the actual amount of time spent providing primary care services, it is nonetheless illustrative of the potential inadequacy of the 126 nat'l health serv. corps, u.s. dep't of health and human servs., slrp grantees: state loan repayment program, nhsc.hrsa.gov, http://nhsc.hrsa.gov/currentmembers/stateloanrepaymentprogram/index.html (last visited oct. 27, 2013). 127 nat'l health serv. corps, u.s. dep't of health and human servs., slrpfunding requirements: cost-shanng requirement, nhsc.hrsa.gov, http://nhsc.hrsa.gov/currentmembers/stateloanrepaymentprogram/fundingli ndex.html (last visited oct. 27, 2013). 128 nat'l health serv. corps, u.s. dep't of health and human servs., slrp ehgibility requirements: elgible sites, nhsc.hrsa.gov, http://nhsc.hrsa.gov/currentmembers/stateloanrepaymentprogramleligibility /index.html (last visited oct. 27, 2013). 129 ind. state dep't of health, supra note 123. 130 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 39. 131 ind. state dep't of health, mapping indiana community health centers, fiscal year 2008 2 (2007). 132 rd. vol. 11:2862 medical care in rural indiana community health centers to broadly service a large percentage of the population which is medically underserved. additionally, notwithstanding the existence of these community health centers, many rural areas remain medically underserved and still suffer a shortage of medical professionals. 13 3 the indiana department of health has partnered with minnesota department of health and the wisconsin department of health services to fund promulgation of an assessment and plan to aid rural medical facilities in recruiting and retaining health professionals. 134 these state departments charged the national rural health resource center ("resource center") and national rural recruitment and retention network ("retention network") to create the assessment and plan, and the resource center and the retention network released its product called the midwest retention toolkit ("the toolkit") in 2012.135 specifically, the toolkit is intended to provide medical facilities that are located in medically underserved areas insightful data and methods to retain physicians practicing in their facilities under the national health services corps loan repayment programs. 136 the toolkit contains sample strategies in the areas of physician orientation and assimilation, physician compensation, mentoring, workplace recognition, and workplace departure of which medical facilities may implement.137 all of the aforementioned federal and state programs are pertinent measures of focusing governmental resources on medical care inaccessibility in rural areas. some of these measures take aim at geographic inaccessibility of medical care while others are designed to foster the medical practice of health professionals in rural areas. some of these measures are more effective than others due to their very 133 health res. & servs. admin., u.s. dept of health & human servs., supra note 22, at 8. 134 the nat'l rural health res. ctr. & the nat'l rural recruitment and retention network, midwest retention toolkit 2012 i, 1 (2012), available at http://www.in.gov/isdh/24409.htm. 135 id. 136 id. at 1. 137 id. at 4-8, 11-55. 2014 863 indiana health law review nature. direct measures, such as the federally qualified health centers, increase accessibility more than indirect measures such as the toolkit mentoring strategies. however, not a single measure alone can bring about a sweeping change in the distribution of medical resources. only all of the above mentioned measures combined and with the addition of some direct, human capital oriented, and financially vigorous legislative measures may begin to accelerate and widen the accessibility of medical care within rural indiana. b. critical access hospitals critical access hospitals ("cahs") are indispensable to the healthcare network in indiana. these hospitals are located strategically in rural areas where other sources of medical care are scarce or wholly absent. the construction of new critical access hospitals is a great starting point to address the inaccessibility of medical care in indiana. under the social security act, any state may submit an application to establish a medicare rural hospital flexibility program ("flex program").138 in taking part in this flex program, a state must designate at least one medical facility as a critical access hospital. 139 in order to receive a critical access designation, a medical facility must meet the following non-exhaustive criteria: i. is a hospital that is located in a county (or equivalent unit of local government) in a rural area (as defined in section 1395ww(d)(2)(d) of this title) or is treated as being located in a rural area pursuant to section 1395ww(d)(8)(e) of this title, and thatii. is located more than a 35-mile drive (or, in the case of mountainous terrain or in areas with only secondary roads available, a 15-mile 138 42 u.s.c. § 1395i-4(a) (2012). 139 id. § 1395i-4(b)(b). 864 vol. 11:2 medical care in rural indiana drive) from a hospital, or another facility described in this subsection; or iii. is certified before january 1, 2006, by the state as being a necessary provider of health care services to residents in the area;140 the hospital must also provide twenty-four hour emergency care services. 141 there are additional requirements that will not be mentioned here.142 states that have submitted an application to establish a flex program may receive grants from the federal government to assist in implementing the program and increasing medical care quality in critical access hospitals. 143 currently, there are thirty-five critical access hospitals operating in indiana. 144 these cahs however suffer a shortage of health professionals. 145 specifically, it is estimated that on average each indiana cah has from one to seven full-time job openings per week. 146 cahs also suffer from an inability to staff part-time positions. 147 moreover, filling these positions could not be completed in less than several months. 148 in order to increase the effectiveness of existing cahs, state recruitment and retention measures of health professionals must be adopted. c. geographic accessibiity state-owned and operated criticalaccess hospitals and support for the establishment ofacute care and primary care hospitals in fiscal year 2009, indiana received the least amount of funding (fiftieth) from the hrsa. 149 in the same year, 140 id. § 1395i-4(c)(2)(b))(i-(ii. 141 id. § 1395i-4(c)(2)(b)(ii). 142 id. § 1395i-4(c)(2)(b)(iii)-(v). 143 id. § 1395i-4(g)(1)(a)-(d). 144 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 33. 145 see id. at 62. 146 id 147 see id. 148 id 2014 865 indiana health law review indiana ranked forty-eighth in the amount of funding received from the center for disease control.15 0 moreover, the state of indiana falls behind forty-six states in funding public health.151 the failure of the state government to acquire federal funding and to adequately provide state funding to strengthen the health of its residents is regrettable. indiana must diligently strive to obtain federal benefits in order to comprehensively fortify the healthcare delivery system and support the health of its residents. if indiana decides to address the inaccessibility to medical care problem, then federal funding must be exploited as much as possible in order to limit the extent to which state monies are diverted from state programs in other areas. due to the recent downturn in the economy, states' budgetary capacities have dwindled. due to this drop in revenues, budget wars have ensued with each political party targeting different expenditure programs for cuts. a failure to rely on federal monies in combination with a continuing reliance on the expenditure of state monies to increase access to healthcare at the state level may exacerbate the targeting of important state or local expenditure programs outside the realm of healthcare. of course, it may be argued that a potential exacerbation of budget cuts could be avoided by deferring reformation of healthcare to more prosperous times. however, this approach is untenable because the consequences of an unhealthy population are detrimental in the short term and in the long run. what is more, if indiana continues to fall behind in acquiring federal funds then the state will shoulder a substantial amount of the costs in reforming the healthcare delivery system. a continued failure to acquire federal funding while implementing accessibility measures at the state level may force the state to unnecessarily increase taxes on hoosiers. while some of the legislative measures proposed below will require an increase in taxation, the increase may be lessened through reliance on federal monies. 149 id. at 14. 150 id. 151 id. vol. 11:2866 medical care in rural indiana while federal initiatives and financial support are needed to resolve the inaccessibility of medical care, the state government is in a better position to understand the shortcomings of the local healthcare system and the complexities therein involved. 152 despite the fact that the federal government has many resources at its disposal, the state government would most likely be better able to evaluate the current state of medical inaccessibility in rural indiana. the state government's scope of evaluation is geographically smaller, whereas the federal government must evaluate the state of healthcare throughout the united states. this large federal scope of evaluation takes resources such as time and money away from indiana. additionally, channels of information sharing at the state level are more easily ascertainable and direct than those at the federal level. the sheer size of the federal government as compared to state governments may create the risks of misdelivery of information and the proliferation of misinformation. valuable information about the nuances of healthcare system and the general state thereof in indiana can be streamlined to the appropriate state agencies. this streamlining of information would allow the indiana legislature to efficiently expend resources toward the heart of the nuanced issue. additionally, the state government must live with the detrimental consequences of an ill-functioning system of healthcare. deprivation of good health in indiana most likely affects the local economy. poor economies have the potential to undermine governments in several ways. continued governmental inaction might maintain or even worsen the substandard performance capacity of rural economies resulting in a continued reliance on social welfare funds, the minimization of taxation sources, and an overall stagnation of progress. it is imperative that the indiana legislature recognize its failure to adequately address the inaccessibility of healthcare in rural areas and seek to remedy the disparity 152 see kristine marietti byrnes, is there a piimary care doctor in the house? the legislation needed to address a national shortage, 25 rutgers l.j. 799, 834-35 (1994). 2014 867 indiana health law review through direct financial support. if left unresolved, the prevalent inaccessibility of healthcare in rural communities could continue to degrade the health of rural citizens and hamper those rural communities from progressing educationally and economically. in order to directly advance accessibility, the indiana legislature should establish some state-owned and operated critical access hospitals and partner with indiana university health or any willing private entity to establish new acute and primary care hospitals in counties where they are nonexistent or highly needed. under the indiana flex program, a statutory transition of small rural hospitals into cahs is one of four objectives. 15 3 while this objective is a positive step toward acquiring more federal funding for indiana's rural healthcare delivery system, it falls short of proactively and directly advancing accessibility in rural communities. specifically, the rural hospitals that are intended for transition already exist. the transition would increase funding, but it would not dramatically expand accessibility. the construction of state-run critical access hospitals on the other hand would immediately expand accessibility in communities where no medical facility exists. it is estimated that it would costs anywhere from 10.8 to 12.1 million dollars to construct a two or three story hospital in washington, indiana. 154 due to the exorbitant costs of constructing and operating hospitals, indiana should plan to construct a minimal number of critical access hospitals in rural areas where they are most needed. another option is to acquire existing buildings and convert them into hospitals. this would most likely be a less expensive route. also, it might be possible for indiana to receive federal funding to aid in meeting the costs of 153 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 51. 154 rsmeans; construction cost estimates for hospital (2-3 story) in washington, indiana, reedconstructiondata.com, http://www.reed constructiondata.com/rsmeans/models/hospitallindianalwashington/ (last visited oct. 18, 2013). washington, indiana was used for the construction cost estimate because of its rural location. vol. 11:2868 medical care in rural indiana construction, acquisition, and operation of these critical access hospitals.15 5 the state-run facilities should be small rural hospitals, much like the other indiana critical access hospitals. they would provide acute care and primary care medical services, including immeasurably important services such as obstetrics. the state of indiana already operates six psychiatric health hospitals.15 6 this operation could act as a model for state-operated acute and primary care hospitals. there are many advantages of state-run hospitals. the establishment of state-run hospitals is the most direct legislative means to facilitating better access to healthcare in rural communities. if strategically placed, the establishment of these state-run hospitals would immediately open the door to medical care access. this establishment would remove barriers to obtaining medical services. in particular, rural residents would no longer be required to drive counties away to see a physician, and also timely treatments could be obtained. moreover, these small hospitals would obviously have a larger operating capacity than existing community health centers, and therefore they could provide more services to many more rural patients. indiana might be able to eventually remove the medical underservice and the professional shortage area designations if it establishes state-operated hospitals and partners with iu health or a private entity to further expand its operations. another advantage is that state-run facilities would not operate on the principal of maximizing profit, but rather their primary goal would be to provide as many health services as needed to the most people as possible. also, 155 42 u.s.c. § 1395i-4(g)(a)-(c) (2012) (whether or not grants may be awarded for construction costs is unclear and this determination revolves around the secretary's interpretation of the statute); id. § 254(b)(c)(1)(a) (authorizing the secretary to award grants to public entities to aid in acquiring buildings and equipment in the establishment of health centers); id. § 254(b)(e)(1-2) (giving discretion to secretary to award grants to health centers to meet operating costs). 156 div. of mental health & addiction, ind. family & social servs. admin., mental health services. state psychiatric hospitals, in.gov, http://www.in.gov/fssaidmha/4325.htm (last visited oct. 18th, 2013). 2014 869 indiana health law review state-run facilities could potentially lessen the burden on non-profit hospitals of providing patient care. additionally, state-run facilities could potentially assume more of the uncompensated patient care expenses of which non-profit hospitals in indiana shoulder the most. 157 lastly, the spending of funds for state-operated hospitals would be more transparent and easily traceable than subsidies given to private institutions. building some state-run hospitals would create jobs in rural areas and would also in turn foster a growth of support industries and businesses around these medical centers. at the start for example, the state would award construction contracts to companies to build the hospitals which would require those companies to hire laborers. this would immediately create ancillary jobs. also, once these new hospitals began operation, they would immediately create demand for health goods. it is estimated that american hospitals spend 702 billion dollars on goods and services. 15 8 these operating expenditures have created a 9.9 million job market outside of the hospital infrastructure.159 there are of course disadvantages of establishing staterun hospitals. the most obvious disadvantage of state-run hospitals is the potential for high and unbearable costs of construction, maintenance, and operation which taxpayers must bear. building the hospitals would require the state to take bids on and pay out construction contracts of ten to twelve million dollars each. 160 paying health care professionals to work in these facilities is not the only operational cost associated with establishing state-run hospitals. additionally, the state would have to purchase expensive medical devices and supplies. the state would 157 david m. walker, u.s. gov't accountability office, gao-05743t, nonprofit, for-profit, and government hosprrals: uncompensated care and other community benefits 11 (2005), available at http://www.gao.gov/new.items/d05743t.pdf. 158 american hosp. ass'n, economic contribution of hospitals often overlooked (2013), available at http://www.aha.org/content/13/ 13brief-econcontrib.pdf. 159 id 160 however the state might be able to obtain federal funding to assist in meeting these costs. 870 vol. 11:2 medical care in rural indiana also be required to staff administrative positions in order to properly operate the facilities. in general, most likely 44 percent of a state-run rural hospital's expenses would be attributable to labor costs.1 6 ' however, the severity of these costs can be mitigated by the adoption of a dualistic operating-model whereby the state government operates some hospitals and a private entity operates others. another potential disadvantage, and one which is oft cited whenever government provided health care is debated, is the claim that government will refuse expensive and important treatment for certain ailments in order to avoid costs. this assertion however unconvincingly presupposes an indifferent governmental predisposition toward the wellbeing of its citizens. this argument is also propounded in terms of demonizing labels, and it usually refers to government involvement in the provision of medical care as socialized medicine. however, it is not proposed here that the state government should assume the role of great arbiter of medical treatment or much less even seek to minimize the involvement of the private sector in the medical industry. all that is proposed here is that state government should provide an important service where the private sector refrains from doing so. even though there are many advantages of state-owned and operated critical access hospitals, it is necessary to contemplate supplementary or alternative measures which are financially more reasonable. thus, a supplement or an alternative to state-owned and operated critical access hospitals is a state funded expansion of iu health into rural areas. under this model, the state government would bear part of the costs of constructing the hospitals. conversely, iu health would operate and maintain the hospitals. iu health therefore would pay medical supply, labor, general operation, and maintenance costs yet it would avoid most of the acquisition or construction costs. another supplementary or alternative approach would be privatization of the expansion of hospitals into rural areas. under this approach, the state government would 161 affiliated serv. providers of ind., inc., ind. state dep't of health, supra note 2, at 37. 8712014 indiana health law review operate a smaller number of rural hospitals, but it also would provide benefits to private healthcare companies who expand and establish healthcare facilities in rural areas. particularly, under this model, in order to incentivize companies to establish small rural hospitals, the state government would create tax incentives. these tax incentives could take the form of qualified excepted income and significant tax credits. of course, these incentives would only be applicable for a defined statutory period. this privatization approach, unlike the aforementioned approaches, significantly decreases the amount of out-going expenditures. however, it also decreases the amount of incoming tax revenue. despite this, this hybrid approach is feasible, viable, and it has the potential to bring better access to medical care to rural areas. d. medical personnel accessibility. the 'pay-to-drive" and the 'rural practice benefits program" the indiana legislature should enact a program which promotes and facilitates metropolitan and out-ofstate physicians to travel to rural communities within indiana to practice for limited duration on a regular basis. this hypothetical program will be referred to as the "pay-todrive" program. this program would pay 40 percent of the traveling physician's compensation per day (of what the physician would have earned working at his principal hospital or facility) when working in a designated health professional shortage area or medically underserved area, and it would also pay traveling expenses. rural hospitals wishing to participate would be required to pay at least 65 percent of the traveling physician's contractual compensation. in all, the traveling physician would earn 105 percent per day of his normal pay. under the program, the state would also provide tax benefits to the principal medical institutions where the traveling physician normally works. these tax benefits would constitute tax credits. these tax benefits conferrable to the traveling physician's principal hospital would act as incentive for metropolitan hospitals to leave room in 872 vol. 11:2 medical care in rural indiana physicians' contracts to allow them to participate in the "pay-to-drive" program. specifically, these tax benefits, by decreasing tax liability, would be a form of compensation for the metropolitan hospitals for their temporary loss of human capital. also, the program would cap the number of days available for qualifying metropolitan physicians to travel to rural areas. this restraint would exist to avoid high costs. additionally, the program would specify the days that physicians practicing at the same principal hospital could participate in order to ensure the principal hospital's capacity to meet the needs of its patients. metropolitan physicians wishing to participate in the program would be required to apply to become a traveling physician. in order to qualify, the metropolitan physician would be required to show that he or she had not been assessed more than two malpractice judgments in the last ten years of practice. this condition of participation would ensure that quality care would be provided to rural patients. after successful participation in the pay-to-drive program for three years, the traveling physician would be permitted to apply to the "rural practice benefits program." successful participation in the pay-to-drive program would constitute no more than one malpractice judgment assessed against the physician in the last three years. also, to gain acceptance into this program, the traveling physician would necessarily have to submit at least two letters of recommendation from two senior (defined as number of years in practice) rural physicians with whom the traveling physician has worked. upon acceptance into the rural practice benefits program, the physician would be placed in a medically underserved rural area or health professional shortage area to work, and the physician would receive at least 100 percent of his former contractual compensation for five years (to be paid wholly by the rural medical institution). additionally, the physician would be allowed to exclude from his income the amount of his compensation on his state return for five years, which would result in tax free compensation. moreover, the physician's principal 8732014 indiana health law review residence would not be assessed a state real property tax for five years. e. conclusion in implementing some of the judicial measures aforementioned, particularly the adoption of gross negligence, the quality of care may be lowered. however, the risk of minimal degradation in quality of care is outweighed by the expansion of accessibility of medical care in rural areas. specifically, it is better for individuals to have access to at least some care rather than to have no access at all. once the inaccessibility of medical care is no longer a devastating problem, more quality measures should then be implemented to bolster sound medical performance. some of the legislative measures proposed here, such as the establishment of some state-run critical access hospitals, would be monetarily burdensome on the state government. however, increasing access to healthcare in rural areas is not a cheap endeavor. the high costs of establishing more hospitals can be lowered through hybrid measures which shift costs to the private sector. however even then, the state government must incur losses in the form of lost revenues due to the provision of tax incentives. due to the high costs of direct state legislative action in this area, existing programs must be heavily relied on. also, new measures such as the ones proposed here should be adopted and implemented lightly and with caution. only after a newly implemented measure is proven to produce outstanding access to healthcare in rural areas should more resources be expended to enlarge its effect. in summary, only a combination of impactful and thoughtful judicial measures can effectively begin to remedy the disparity of accessibility of medical care in indiana. more importantly, judicial solutions alone will probably only result in lackluster results. thus, it is imperative to consolidate judicial remedies with legislative ones in order to provide a comprehensive counterbalance to the inaccessibility of medical care. 874 vol. 11:2 protecting dr. smith while treating the chronic pain of mrs. jones: why the indiana medical licensing board should pass guidelines for using controlled substances for pain treatment macon jones • "the end of law is not to abolish or restrain, but to preserve and enlarge freedom. for in all the states of created beings, capable of laws, where there is no law, there is no freedom. " -john locke1 i. introduction .......................................... ; .................................... 696 ii. background ................................................................................ 699 iii. the current status of interested parties for indiana's policies concerning controlled substance prescribing for pain treatment ........................................................................... 701 a. the patient ............................................................................... 701 b. the prescribing physician ....................................................... 703 1. duty to treat patient pain ................................................ 703 2. interest in perpetuating practice in medicine .................. 704 c. the office of the indiana attorney general ............................. 706 d. the indiana medical licensing board ..................................... 708 iv. the guideline solution ............................................................. 709 a. the model policy ..................................................................... 709 b. the michigan guideline .......................................................... 711 c. indiana's attempt to promulgate a rule for using controlled substances in 4 pain treatment setting ................................... 713 d. how a guideline would operate under indiana's statutory scheme ................................................... -.................................. 715 v. the role of a guideline to achieve and balance all interest ........................................................................................ 716 a. a guideline will clarify the law and create case evaluation criteria ..................................................................................... 717 • j.d. candidate, 2012, indiana university rqbert h. mckinney school of law; b.a., 2005, university ofnorth florida. 1. john locke, the sboond treatise of cml government chap. vi, sec. 57 (1690). 696 indiana health law review · [vol. 9:2 1. the indiana medical licensing board members are not pain management specialists ................... ; .. ; .................... 717 2; the case of david and charles chube ............................. 718 b. clear standards put physicians on notice as to proper prescribing practices ............................................................... 722 1. a guideline will alleviate fear of regulatory scrutiny ... 722 2. a clear guide will enable proper defense ...................... 723 c. the patients will receive better treatment ............................ 725 vi. the case against a guideline .................................................. 725 a. there is no enforceability with a guideline ........................... 725 b. restricts the practice of medicine ........................................... 728 c. specific standards are not necessary to achieve physician discipline ................................................................................. 729 d. patient concern of required documentation .......................... 729 vll. conclusion .................................................................................. 729 i. introduction a war is raging; it is one that includes all members of society: the in­ digent, wealthy, young, old, and all flavors of race, nationality, and gender. it is the war on prescription medication. according to the drug enforce­ ment administration ("dea"), six million americans currently abuse a prescription drug, which is more than abusers of heroin, cocaine, hallucino­ gens, and inhalants combined.2 1.85 million people are estimated to be de­ pendent on or abusing schedule ii controlled substances, also known as opioids.3 in 2009, 1.2 million individuals were treated in an emergency department for conditions involving pharmaceutical drug use, which is a ninety-eight percent increase from 2004.4 this increase is especially star­ tling considering that emergency room treatment involving illicit drugs has remained virtually unchanged over the same period.5 in response, federal and state governments have taken multiple steps to address this serious and growing problem. on september 25, 2010, the dba held its first ''national 2. practitioner's manual, drug enforcement admin. office of diversion control, http://www.deadiversion.usdoj.gov/pubs/manuals/ptact/sectionl.btm (last visited mar. 11, 2012). 3. cynthia gregorian, addiction to painkillers hobbles more patients, stl today (oct. 27; 201 0), http://www.stltoday.comllifestyleslhealth-med-fitlfitnesslarticle _ :ffi777202785b-5703-9319-l7df8d32c29b.html. schedule ii controlled substances are beneficial and effective medications that also have a high potential for abuse and addiction, thus, their use is regulated. 21 u.s.c. § 812(bx2)(201l). 4. abby goodnough, prescription drug abuse sends more people to the hospital, n.y .. times, jan. 5, 2011, http://www;nytimes.com/2011/01/06/bealth/06drugs.html?_ r=2&ref=bealth. 5. id 2012] guidelines for using controlled substances for pain 697 prescription drug take back day" which allowed anyone to return unused prescription medication with no questions asked 6 this activity was moti­ vated by the desire to reduce the amount of unused medication available for diversion.7 further, in recent years the dea has stepped up its investiga­ tions and prosecutions of physicians, especially those who prescribe oxy­ contin, a schedule ii controlled substance and one of the most widely prescribed and abused opioids. 8 indiana has a particularly concerning controlled substance abuse prob­ lem. in the most recent substance abuse and mental health services ad­ ministration ("samhsa") report, indiana ranked among the highest in the country for non-medical ~in reliever use in all age groups except ages twelve through seventeen. however, indiana has also adopted measures to combat prescription drug abuse and diversion, including indiana's con­ trolled substance monitoring program ("inspect" program) created in 2006,10 and the passage by the state legislature of the prescription drug disposal sites house bill 1121,11 which would allow individuals to return unused medications to their pharmacy for proper disposal.12 also, in the past year the office of the indiana attorney general has prosecuted numer­ ous physicians who divert and improperly prescribe prescription drugs.13 prescription drug abuse has become a crisis nationally and in indiana and more safeguards are needed. however, in developing additional safeguards by regulating access to prescription drugs, one must be careful not to unnecessarily restrict access from legitimate users.· while prescription drugs are widely abused, they can also provide life altering relief from pain that cannot otherwise be treated. as a casualty in the war on prescription drug abuse, undertreated pain has quietly become a nationwide epidemic.14 many factors contribute to under6. national take back initiative, drug enforce. admin. office of diversion control, http://www.deadiversion.usdoj.gov/drug_disposalltakeback/ (last visited jan. 17, 2011). 7. ld. 8. ronald t. libby, treating doctors as drug dealers: the dea 's war on prescrip­ tion painkillers, 545 pol. analysis 1, 1 (2005), available at http://www.cato.org/pubs/pas/ pa545.pdf. 9. substance abuse & mental health servs. admin., u.s. dep't of health & human servs.,indiana, states in brief: substance abuse and mental health issues at-a-glance, a short report from the office of applied stijdies (2009), available at http://www.samhsa.gov/statesinbriet72009/indiana_508.pdf. 10. ind. code§ 35-48-7-10.1 (2010). 11. h.b. 1121, 117th gen. assemb., 1st reg. sess. (ind. 2011), available at http:/ /www.in.gov/legislativelbills/2011/pdfihbihb 1121.2.pdf. 12. press release, ind. att'y gen., ag, legislators support bill for safe disposal of prescription drugs (jan. 10, 2011 ), http://www.in.gov/attomeygeneral/2369.htm. 13. see findings of fact, ultimate findings of fact, and order, in the matter of the license of beverly p. edwards, 2009 mlb 0024 (ind. med. licensing bd.,, mar. 30, 2010) [hereinafter edwards, findings offact and order]. 14. ben a. rich, a prescription for the pain: the emerging standard of care for 698 indiana health law review [vol. 9:2 treated pain, but one important influence is physician concern about both law enforcement and regulatory scrutiny: physicians are reluctant to pre­ scribe adequate amounts of controlled substances for pain because of the potential for investigation by the dea and the state medical licensing board.15 as a result, patients indirectly suffer from amped-up efforts to control prescription drug abuse by focusing on physician prescribing prac­ tices. therefore, regulations placed on prescription drugs must consider all interests implicated and fashion a strategy that serves to address prescrip­ tion drug abuse while allowing doctors to adequately treat the pain of their patients. this note will argue that the indiana medical licensing board should pass guidelines for the use of controlled substances for the treatment of pain. guidelines would address the ever-increasing concern over prescrip­ tion drug abuse by creating a standard that would allow physicians to pre­ scribe proper amounts of controlled substances for pain treatment without fear of investigation. in addition, guidelines would provide a method for the office of the indiana attorney general to assess and take appropriate action against physicians who use medicine as a pretext for diversion and ultimately are not prescribing for legitimate medical purposes and give the indiana medical licensing board an evaluation tool to properly scrutinize physician prescribing practices. this note will consider the interests impli­ cated by the adoption of guidelines for controlled substances in the context of pain treatment including patients, physicians, the office of the indiana attorney general, the indiana medical licensing board, and indiana citi­ zens generally. further, this note will consider several disciplinary actions and criminal convictions of indiana physicians who have been disciplined for their prescribing practices and compare indiana law and regulations with the efforts of michigan in the area of pain management using controlled substances. this note concludes that guidelines adopted by the indiana medical licensing board will serve all interests involved and will amelio­ rate prescription drug abuse and diversion while alleviating undertreated pain and physician fear in indiana. pain management, 26 wm. mitchell l. rev. 1, 2 (2000); see also david b. resnik et al., the undertreatment of pain: scientific, clinical, . cultural, and philosophical factors, 4 med. health care phil. 277 (2001) (arguing that undertreatment of pain is due to a faulty philosophical approach to pain management); steven e. stark, bio-ethics and physician liability: the liability effect of developing pain management standards, 14 st. thomas l. rev. 601, 638 (2002) ("there is an increasing perceived inability of the medical profession to deliver adequate pain management and adequate palliation of pain to those with acute or chronic illness and to those with terminal illness."); but see norman miller et al., controlled substance laws: are they meeting the health needs of the public?, 7 mich. st. j. med. & law 81, 83 (2003) ("in the past ten years or so, a growing mood of entitlement of absolute pain relief has obscured decades of hard earned wisdom that narcotic medications contain inherent 'pain' ftom their pharmacological effects, and addictive properties that are not ne­ gated by the presence of pain in an individual.''). 15. aaron gilson, et al., improving state medical board policies: ltifluence of a mod­ el, 31 j.l. men. &ennes 119, 119 (2003). 2012] guidelines for using controlled substances for pain 699 ii. background in indiana, there are two agencies that are involved in regulating the professional practice of physicians~ the office of the indiana attorney general ("ag") is the investigative and prosecutorial arm, 16 and the indiana medical licensing board ( .. board") is the entity that licenses and disci­ plines physician practice.17 any action conducted by these agencies only relates to the physician's license and ability to legally practice medicine in indiana.18 no criminal penalties are imposed, although a finding of unpro­ fessional conduct allows for discipline on the physician's license.19 the process begins when the ag receives allegations of improper physician conduct, which can come from a variety of sources, including patient com­ plaints~ other state disciplinary committees, media outlets, and the board itself.2u after receiving this information, the ag conduc~ an investigation of the alleged conduct, including a response to the allegations by the physician in question.21 after a thorough review of the information available, the ag makes a recommendation of the action to be taken and submits it to a mem­ ber of the board for their comments and impressions. 22 based on the board member's comments and in-house attorney recommendations, the ag will then decide whether to file a formal administrative complaint against the physician or close the matter altogether?3 in the event that the ag decides to take action against the physician's license, they will file a formal admin­ istrative complaint with the board. 24 the complaint will allege that the physician has committed a licensing violation under indiana code ("ic") section 25-1-9-4, 25 which is commonly referred to as the licensing charg· ing statute.26 the physician will then either decide to settle with the ag, subject to the board's approval; or defend the allegations in an administra­ tive hearing before the board.2 the ag serves as the prosecution in the 16. ind. code§ 25-1-7-7 (2010). 17. ind. code § 25-22.5-2-7 (20 1 0). the board is a subset of the indiana professional licensing agency ("ipla") which is the official agency charged with regulating all profes­ sional practices in indiana 1ulder ind. code§ 25-l-5-3 (2gl0). 18. ind. code§. 25-22.5-2-7 (2010). 19. ind. code§ 25-1-94 (2010). 20. see consumer complaints, office of the ind. arr'y general, http://www.in. gov/attomeygeneral/2434.htm (last visited mar. 11, 2012). · 21. interview with gabrielle owens, section chief. licensing enforcement and homeowner protection unit, office of the ind. att'y gen., in indianapolis, ind. (feb. 28, 2011) (on file with author). 22. id. 23. id. 24. !d. 25. id 26. ld. 27. id; see also stipulated findings of fact, stipulated conclusions of law, ultimate conclusions of law, and order, in the matter of the license of michael a. p\ulnett, 2009 700 indiana health law review [vol. 9:2 hearings. 28 the hearing takes place before the board, which is comprised of up to seven members appointed by the govemor?9 six board members are phy-'­ sicians from all over indiana, and at least one physician must be a doctor of osteopathy while the other five must be doctors of medicine. 30 the last member is a consumer member that can be anlt citizen of indiana and serves as a representative of all indiana consumers. 1 the board is charged with regulating physician practice in indiana and protecting consumers from fraud and abuse by licensed physicians. 32 the board primarily consists of physicians because it is believed that they are in the best position to evalu­ ate medical practice. 33 as such, the board promulgates rules for the prac­ tice of medicine, approves physicians for licensure, and disciplines physicians who violate indiana law and the professional standards for the practice of medicine set by the board. 34 the board may discipline the phy­ sician's license by issuing a letter of public reprimand; by taking action on the physician's license, including revocation, suspension, or probation; by imposing fines up to $1,000 for each violation; or by a combination of the penalties listed. 3 in order to impose disciplinary action on a physician's license, the board must find that the physician violated one of the thirteen provisions found under ic 25-1-9-4 ("charging statute").36 such provisions prohibit physician-patient sexual relations, prescription drug diversion, the use of material deception to obtain a license to practice, failure to keep abreast of current professional theory or practice, and others.37 moreover, the board is authorized to promulgate additional rules,38 a violation of which would constitute varying violations of the charging statute. 39 these rules are tai­ lored to address "standards of professional conduct and competent prac­ tice of medicine" and are codified in the indiana administrative code ("lac") title 844, section 5.4° for example, ic 25-1-9-4(a)(4)(b) requires mlb 0032 (ind. med. licensing bd., jun. 30, 2010). 28. ind. code§ 25-1-7-2 (2010). 29. ind. code§ 25-22.5-2-1 (2010). 30. ind. code§ 25-22.5-2-1(1) (2010); ind. code§ 25-22.5-2-1(2) (2010). 31. ind. code§ 25-22.5-2-1(3)(2010). 32. ind. code§ 25-22.5-2-7 {2010). 33. see generally ind. code § 25-22.5-2 (2010). 34. ind. code§ 25-22.5-2-7 (2010). 35. ind. code§ 25-1-9-9 (2010). 36. ind. code§ 25-1-9-9 (2010). this statute recognizes two other specific instances in which the board has authority impose discipline, which are indiana code section 25-1-96.8, "practitioner guidelines before prescribing stimulant medication for a child for treatment of certain disorders," and indiana code section 25-1-9-6.9, ''failing to provide or providing false information to agency." however, these statutes are rarely invoked and the discipline in the scope of this note is covered under the charging statute. 37. ind. code§ 25-1-9-4 (2010). 38. ind. code§ 25-22.5-2-7(2010). 39. see ind. code§ 25-1-9-4 (2010). 40. 8441nd. admin. code 5 (2010). 2012] guidelines for using controlled substances for pain 701 physicians to "keep abreast of current professional theory and practice,'.41 and a violation of 844 lac 5-3-3, which disallows treatment based on on­ line questionnaires,42 would invoke. the charging statute causing the ag complaint to charge the physician with a violation ofic 25-1-9-4(a)(4)(b) to wit, 844 lac 5-3-3, because the board must prosecute for a violation of the charging statute.43 while some of the provisions appear to be criminal in nature, all provisions under the charging statute are licensing violations subject to discipline by the board against the physician's license.<w iii. the current status of interested parties for indiana's policies concerning controlled substance prescribing for pain treatment when statutes, regulations, or policy statements are adopted, passed, and implemented, unintended parties may be affected for good or ill. espe­ cially in the area of health law, where life-saving work is being performed, a careful examination of all implicated parties is necessary to properly bal­ ance the interests and devise an appropriate strategy for accomplishing the desired goal. for the purposes of this note, the interested parties are pa­ tients, prescribing physicians, the ag, the board, and the general public. patients receive pain treatment through appropriate physician prescribing; the physicians prescribe and earn a living through their practice; the ag is· empowered by the state to protect the health and welfare of indiana citizens by bringing complaints against licensed indiana physicians; the board is empowered to protect the health and welfare of indiana citizens by disci­ plining the license of indiana physicians; and, the indiana public has an in­ terest in protection from prescription drug abuse. a. the patient in the context of using controlled substances for pain treatment, the patient's interest is receiving safe and effective pain treatment and relief from suffering.45 patients are the ones who are experiencing pain and are in need of help. generally, three types of pain are recognized: acute, chronic 41. ind. code§ 25-1-9-4(a)(4xb) (2010). 42. 8441nd. admin. code 5-3-3 (201 0). 43. edwards, findings offact and order, supra note 13. 44. for example, indiana code section 25-1-9-4(a)(8)(a) which states "a practitioner has diverted: a legend drug (as defined in ic 16-18-2-199)" is a licensing violation subject to discipline by the board under indiana code section 25-1-9-9, but would also be a viola~ tion of indiana code section 35-48-4-2, "dealing in a schedule i, it, or ill controlled sub­ stance," and subject to criminal prosecution as a class b felony. 45. rich, supra note 14, at 31 ("the suffering at issue is that of the patient with whom he or she has entered into a professional relationship.''). 702 indiana health law review [vol. 9:2 non-cancer pain, and chronic cancer related pain.46 this note will address chronic non-cancer pain because such pain is outside the scope of palliative care and is frequently targeted by guidelines and provisions to prevent abuse and addiction. 47 . · · "chronic non-cancer ~ain is. associated with significant economic, so­ cietal, and health impact.' 8 on the economic front, the cost of uncon-:­ trolled non-cancer chronic pain is extreme. in 1998 it was estimated that total expenditures for back pain was $90.7 billion and, on average, people with back pain cost health care insurance providers sixty percent more than those without back pain.49 "it was estimated [in 1998] that the cost of health care for patients with chronic pain might exceed the combined cost of treating patients with coronary artery disease, cancer, and aids.',so from a societal perspective, undertreated pain directly impacts a patient's quality of life. 51 it is not easy living with unremitted moderate to severe pain, and, in certain cases, excessive pain can lead to depression and even suicide. 52 undertreated pain has been equated and compared to inflicting pain on the suffering patient and, as such, has implicated ethical and judi­ cial/licensing liability concerns. it is argued that "[h]ealth care providers also should not inflict unnecessary pain and suffering .... [a]llowing a patient to experience unnecessary pain and suffering of any form is sub­ standard and unethical medical practice regardless of the nature of the pa­ tient's condition or the goals of medical intervention.',s3 in light of the fact that unrelieved pain is an undue burden on patients, controlled substances in the morphine class known as opioids can be used as safe and effective ways to treat patient pain, especially when the pain is severe. 54 many physicians argue that there is no ceiling on how much one 46. see or. bd. of med. exam'rs. intractable pain and pain management: bme statement of philosophy on pain management (2004), available at http://www.pain policy.wisc.eduldomesticlstates/or/onnbgd2.htm. 47. renata ferrari, michela capraro & marco visentin. risk factors in opioid treat­ ment of chronic non-cancer pain: a multidisciplinary assessment, in pain management~·. culuu!nrlssuesand 0pjnions419, 450 (gabor b. racz and carl e. noe, eds., 2012), avail­ able at http://cdn.intechopen.com/pdfs/26149/lntech-risk_factors_jn_opioid_treatment_of_ chronic _non_ cancer _pain_ a_ multidisciplinary _assessment.pdt: . 48. laxmaiah manchikanti, prescription dnlg abuse: what is being done to address this new dnlg epidemic? testimony before the subcommittee on. criminal justice, dnlg policy and human resources, 9 pain physician 287, 288 (2006). 49. id. 50. id; see also s.h. hernandez & l.s. nelson, prescription drug abuse: insight into the epidemic, 88 clinical pharmacology & therapeutics 307, 310 (2010) (discussing the monetary costs of pain treatment). 51. manchikanti, supra note 47 at 288. 52. see kate scott et al., chronic physical conditions and their association with first onset of suicidal behavior in the world mental health surveys, 72 psychosomatic med. 712 (2010). 53. rich, supra note 14, at 3. 54. amy j. dilcher, damned if they do, damned jfthey don't: the need for a com­ prehensive public policy to address the inadequate management of pain, 13 ann. health 2012] guidelines for using controlled substances for pain 703 may ingest to treat pain asserting that "[a]s long as the dose is [started] low and increased gradually, large doses [may] be taken [and are] limited only by adverse [side] effects .... [o]pioids do not cause damage to major or­ gans. the correct amount, (physicians] argue, is what reduces or eliminates the patient's pain without unacceptable side effects.',s5 therefore, aily re­ striction or regulation on pain patients' access to opioids impacts the pa­ tients' ability to receive powerful solutions to their chronic·and potentially debilitating pain. b. the prescribing physician the physicians implicated in this note are those who prescribe con­ trolled substances to treat their patients' pain. these physicians have a two­ fold interest: their duty to their patients and their interest in perpetuating their practice in medicine. 1. duty to treat patient pain the physician's first interest is in maintaining his duty to properly treat his patients and, in cases of pain management, adequately treating pain.s6 . . when conducting an inquiry into the duties of a phy­ sician, the first step (and sometimes last resort) is to consult the hippocratic oath. however, ... the fact that the oath makes no specific reference to the relief of suffering should not be dispositive of the issue of the physician's duty in that regard. 57 philosopher rem edwards argues that ''there is a broadly based hu­ manistic ethics which applies to the domain of medical care which gives patients· a strong prinul facie right to freedom from unnecessary pain.',s8 further, the world health organization ("who") has recognized pain treatment as a basic human right and has determined that pain treatment is one of the most underestimated health care problems in the world. 59 it is argued that not relieving pain is almost akin to willfully inflicting it, and "[t]he willful infliction of pain is torture, which is foreclosed to the govl. 81, 82 (2003). 55. diane e. hoffinann, treating pain v. reducing drug diversion and abuse: recal­ ibrating the balance in our drug control laws and policies; 1 st. loms u. j. healm l. & pol'y 231, 270(2008). 56. rich, supra note 14, at 2. 57. 1d. at 32-33. 58. jd. at 33. ·59. world health organization supports global effort to relieve chronic pain, world hea.tm oro., oct. 11, 2004, http://www. who.intlmediacentrelnews/releases/2004/pr70/enl. 704 indiana health law review [vol. 9:2 ernment by the eighth amendment to the u.s. constitution, even in the punishment of convicted criminals as 'cruel and unusual. "'60 while the issue of a patient's right to be free from pain is an ethical duty imposed on physicians in indiana, the oregon medical board has dis­ ciplined a physician for under-treated pain and a california jury awarded $1.5 million to the family of a man whose physician failed to provide prop­ er amounts of pain medication before he died of cancer.61 while there is concern that patients can become addicted to powerful opioids prescribed for pain relief,62 especially when a patient has a history of substance abuse, some states have decided that such concerns are no excuse to allow patients to suffer. whether imposed ethically or as a standard of practice, physi­ cians have a duty to adequately address the pain of their patients or at least refer patients for such treatment. 63 2. · interest in perpetuating practice in medicine the physician not only has an interest in relieving his patient's pain on legal and moral grounds, but also has a corresponding interest in maintain­ ing his livelihood. discipline for inappropriate prescribing can lead to the revocation of the physician's license or criminal penalties, thus ending the physician's ability to practice medicine and potentially earn a living.64 the physician must preserve his ability to work. he has a duty to his patients, but maybe a greater one of self-preservation and the continued validity of his license. because of the physician's interest to maintain an unrestricted license, restrictions or lack thereof on opioid prescribing is of major concern to pre­ scribing physicians who are attempting to treat patient pain. considering the war on prescription drug abuse, physicians are often hesitant to aggres­ sively treat patient pain with opioid use out of anticipation that such prac­ tices will draw investigation by state and federal agencies. 65 60. rich, supra note 14, at 49. 61. for the dying and others in pain, doctors rethinking relief, providence j. bulletin,sep. 30,200l,availableat 2001 wlnr4498410. 62. see mich. dep't of cmty. health, survey of physicians 15-16 {2009), availa­ ble· at http:/ lwww.michigan.gov/documentslhealthcareworkforcecenter/2009physicians sur­ veyfinalreport_308082_7.pdf. 63. rich, supra note 14, at 34-35 (2000) ("american doctors regularly refuse to pre­ scribe effective doses of narcotic painkillers to dying patients on the grounds that the patients might become addicted. the treatment of cancer pain, clearly, is still not based solely on scientific fact but draws on ignorance, fear, prejudice, and on an invisible, unacknowledged moral code expressing half-baked notions about the evil of drugs and the duty to bear aftlic­ tion."). 64. edwards, findings of fact and order, supra note 13; beverly p. edwards, 75 fed. reg. 157; 49991-92 (d.b.a. jul. 30, 2010), available at http://www.gpo.gov/fdsyslpkg/fr2010-08-161pdf72010-20193.pdf. 65. rich, supra note 14, at 43 (stating that physicians often have .. opiophobia [which] denotes an unreasonable fear of and resultant reluctance to prescribe, administer, or receive 2012] guidelines for using controlled substances for p a1n [f]ears over the prospect of legal entanglement and potential sanctions may influence doctors to alter their practices in undesirable ways . · ... doctors also fear being subjected to government inquiry or investiga­ tion. the costs of the inquiry or investigation include financial costs, disruption of the practice, damage to reputation, resultant ostracism or termination of nec­ essary business relationships, stress, shame, and other losses that are quite significant. 66 705 in many cases, physicians claim that "bad laws" in the regulatory and legislative system force them to provide futile or poor care because they are more concerned with following the law than adequately treating their pa­ tients.67 the concern here is that unclear or nonexistent law deters physicians from providing proper treatment for their patient's pain because physicians are either scared of government investigation or concerned about following the letter of the law, all to the detriment of the patient. numerous studies have connected fear of regulatory scrutiny and ambiguous standards direct­ ly to incomplete pain treatment. 68 in a 1991 survey of physicians at the american pain society, forty percent of the physicians reported that fear of regulatory scrutiny, and not medical considerations, caused them to pre­ scribe fewer opioids for pain treatment. 69 in a more startling 1993 califor­ nia survey, sixty-nine percent of physicians stated they felt pain treatment was more conservative because of fear of government investigation, and one-third actually believed their patients were suffering from untreated pain. 70 in indiana, there are no statutes, regulations, or standards of prac­ tice specifically tailored to address the use of controlled substances for pain treatment. indiana's "bad law" is the lack of standards by which physicians are evaluated, thus directly contributing to physician fear of regulatory scm­ tiny by promoting ambiguity about the practice of pain management and indirectly preventing indiana citizens from receiving proper pain treatopioid analgesics, even for the relief of severe pain which is unresponsive to other available pain management strategies. while the phenomenon of opiophobia is not unique to ameri­ can culture, the openly declared war on drugs by american politicians and bureaucrats has produced a particularly virulent form of it in this country''); see also amy j. dilcher, damned ifthey do, damned if they don't: the need for a comprehensive public policy to address the inadequate management of pain, 13 .ann. health l. 81, 113-15 (2004). 66. sandra h. johnson, regulating physician behavior: taking doctors' "bad law" claims seriously, 53 st. louis unn. l.j. 973, 1024, 1029 (2009). 67. ld. at 974. 68. diane e. hoffmann & anita j. tarzian, achieving the right balance in oversight of physician opioid prescribing/or pain: the role of state medical boards, 31 j.l. med. & ennes 21,23 (2003). 69. ld. 70. ld 706 indiana health law review [vol. 9:2 ment.71 "until the boundaries between [law and pain treatment] are clari­ fied, physicians will remain reticent to aggressively treat severe intractable pain, and patients will continue to suffer as they struggle to find relief.''72 c. the office of the indiana attorney general as the ag investigates and prosecutes physicians who commit licens­ ing violations, any new or additional regulation will affect that responsibil­ ity, thus impacting its ability to protect indiana citizens. in the context of pain management, there are currently no regulations or standards of practice promulgated by the board, therefore requiring the ag to seek general evi­ dence that a physician's prescribing practice is harmful to the public.73 when prosecuting physicians for prescribing practices under the charging statute, the ag can prosecute for "failure to keep abreast of cur­ rent professional theory or practice,"74 diverting a controlled substance,75 or "except as otherwise provided by law, has knowingly prescribed, sold, or administered any drug classified as a narcotic,. addicting, or dangerous drug to a habitue or addict.''76 ic 25-l-9-4(ax4)(b) ("catch all statute"}, which requires physicians to adhere to current professional theory and practice, is essentially the "catch all" provision used to show that physicians have used substandard care in their practice. however, because of the general language used, the catch all statute must be supplemented by some other source defining the actual conduct that is not professional theory or prac­ tice. generally, violations of the provisions in 844 lac 5, which contains the standards of professional conduct and competent practice of medicine adopted by the board, or other indiana medical statutes are used to invoke a violation of the catch all statute. however, neither 844 lac 5 nor any oth­ er indiana provision addresses prescribing practices for pain treatment, and the ao is left to resort to organizational standards, common knowledge, or expert testimony. 77 in 2010, the ag successfully prosecuted several high profile cases in­ volving prescribing practices, including revocations and fines against the 71. this note recognizes that there are multiple factors contributing to physicians not adequately treating pain. but the burden is on the board to take steps to get patients relief and fear of regulatory scrutiny is something they can directly address. see fed'n. of state med. bds. of the u.s., inc., model poucy for the usb of controlled substances for the treatment of pain (2004), available at http:/lwww.fsmb.org/pdf72004_grpol_con trolled_substances.pdf [hereinafter model poucy] (discussing multiple barriers in pain management including fear of regulatory scrutiny). 72. shannan w. leelyn, failures in pain management: the collision of law and medicine, 27 t. jefferson l. rev. 133, 156 (2004). 73. see 8441nd. admin. code 5-2-5 (2010). 74 •. ind. code§ 25-1-9-4(ax4)(b) (2010). 75. ind. code§ 25-1-9-4(a)(9) (2010). 76. jd. 77. see 8441nd. admin. code 5-2-5 {2010). 2012] guidelines for using controlled substances for pain 707 licenses of dr. beverly edwards, dr. kara benson-rink, and dr. philip fo­ ley. 78 dr. edwards was disciplined under the catch all statute because she prescribed controlled substances to thousands of patients across the country, in violation of 844 iac 5-3, which prohibits internet prescriptions unless the physician physically saw the patient.79 dr. foley was charged under the same statute, but he had written over 96,000 prescriptions over a three-year period, averaging 1.4 prescriptions per minute, and 9 of his patients died from prescription drug overdose.8° further, dr. kara benson-rink was successfully prosecuted under the catch all statute for prescribing vicodin to her husband and a friend without keeping any medical records in viola­ tion ofic 16-39-7-1 and under an expired dea registration.81 in each of these cases, it was clear the physician had prescribed for purposes other than those supported by legitimate medical reasons or in direct violation of a specific statute or regulation, thus invoking the catch all statute and pos­ ing little difficulty for the ag to secure the discipline on their licenses. under the current statutory format, the ag's interest in protecting in­ diana citizens is only served when physicians violate the law in obvious and flagrant ways. however, the interest is not met when physicians keep some form of medical chart, do not prescribe over the internet, or do not prescribe tens of thousands of opioids every month. in more tempered cases where physicians are careless or purposely prescribe for non-medical reasons, the ag lacks adequate tools with which to prosecute. if a physician is purpose­ ly over-prescribing, but maintains semi-proper charts and uses medicine or pain management as a pretext for diversion, the ag can do little under the current statutory scheme. further, where a physician is careless or too trusting of his patients, the ag has a tremendous burden to show the physi­ cian has failed to keep abreast of current theory or practice, especially in an area where addicted patients are unlikely to report such practices. that is because the ag has no standard of practice to support a charge where the physician has ad hoc charts. in such instances, the ag can file a complaint and hope the physician will settle, but, while that might succeed in the latter case, it is unlikely when the physician uses medicine as a pretext for diver­ sion. while the ag has statutory and regulatory backing to prosecute ob­ noxious cases and specific violations, those whose prescribing practices fall 78. findings of fact, conclusions of law, and order, in the matter of the license of philip d. foley, 2009 mlb 0031 (ind. med. licensing bd., apr. 30, 2010) [hereinafter fo­ ley, findings of fact and order]; edwards, findings of fact and order, supra note 13; find­ ings of fact, ultimate findings of fact, and order, in the matter of the license of kara benson-rink, 2009 mlb 0035 (ind. med. licensing bd., apr. 30, 2010) [hereinafter ben­ son-rink, findings of fact and order]. 79. edwards, findings offact and order, supra note 13. 80. foley, findings of fact and order, supra note 77; middletown doctor accused of killing patients with drugs, the herald bulletin, oct 19, 2009, http://heraldbulletin.com/ breakingnews/x546199485/middletown-doctor-accused-of-killing-patients-with-drugs. 81. benson-rink, findings of fact and order, supra note 77. 708 indiana health law review [vol. 9:2 on the borderline pose a much more difficult, if not impossible, challenge. d. the indiana medica/licensing board when the ag prosecutes unlawful physician behavior, the board is the judge, jury, and rule maker. it presides over cases filed by the ag against licensed physicians and d.etetmines discipline with an interest and duty to protect the health and welfare of indiana citizens. 82 that interest is more pronounced considering the war on prescription drug abuse, and the fact that "[t]he largest group of prescription drug abusers is comprised of individuals who abuse opioids."8 empowered by indiana code section 2522.5-2-7{a)(8), the board shall "[a]dopt rules establishing standards for the competent practice ofmedicine, osteopathic medicine, or any other form of practice regulated by a limited license or permit issued under this article.',84 therefore, the board is the gatekeeper as to what rules physicians will abide by in indiana and has the most direct impact. on what rules physicians will follow in their prescribing practices. in its role as judge and jury, the board hears the ag's complaints, evaluates physician conduct, and determines if a licensing violation has oc­ curred under the appropriate statutory and regulatory provisions.85 because there are currently no regulatory policies creating standards for using con­ trolled substances for pain treatment, 86 the board faces the same issues as the ag in determining whether physician conduct is appropriate. while some cases exhibit clear violations by their magnitude or specificity, activi­ ties that toe the line and in the gray areas are difficult to evaluate. because the board is primarily comprised of licensed physicians, they are the most ca~able of determining whether a physician's prescribing practice is prop­ er. 7 however; board members are not necessarily pain management spe82. ind. code § 25·22.5·2 (2010); see also stark, supra note 14, at 607.08 (outlining florida's similar method of regulating physician behavior). 83. manchikanti, supra note 47, at 290; see also norman miller et al., controlled sub­ stance laws: are they meeting the health needs of the public?, 7 mich. st. u. j. med. & l. 81, 94-98 (2003) (discussing high opioid abuse in the united states). 84. ind. code§ 25-22.5-2-7(a)(8)(2010). . 85. ind. code§ 25-22.5; see also rich. supra note 14, at 48 (discussing the customary procedures of state medical boards and its interactions with federal agencies). 86. it is recognized that indiana does have some narrowly tailored provisions such as the indiana uniform controlled substances act of 1973, ind. code § 35-48 (2010), 8441nd. admin. code 5-2-20 (2010) (schedule ii controlled substances for weight reduction), and 8441nd. admin. code 5-3-2 (2010) (evaluation of the patient f~ internet purposes). how­ ever, the scope of this note covers prescribing controlled substances for pain treatment and indiana currently does not have any such statute or regulation. 87. as of april2011, the current board members are stephen huddleston, j.d. (con­ sumer member), bharat h. barai, m.d. (hematology and oncology), donald vennekotter, m.d. (pediatric and general surgery), worthe holt, jr., m.d. (family practice), robert allen, m.d. (urology), lynda smirz, m.d. (obstetrics and gynecology), and kirk masten, d.o. (anesthesiology). list of medical licensing board members as of apri/1011, ind. prof'l 2012] guidelines for using controlled substances for p a1n 709 cialists, and because they are the governor's appointees for finite terms sub­ ject to reappointment, they are subject to pressure from the legislature and the public to protect indiana froid. unlawful physician practices. 88 this pressure is heightened by the fact that indiana is experiencing a crisis in prescription drug abuse and the board, unlike the ag, has the authority and arguably the duty to have appropriate standards by which physicians pre­ scribe opioids. because there are no officially adopted standards of practice when prescribing controlled substances for pain, the board is left to look to other sources to determine whether the physician practice is proper. iv. the guideline solu;rion after review of the interests implicated, it is evident that steps need to be taken to address patient pain treatment, physician prescribing practices, and concern about regulatory scrutiny. in addition, the ag's ability to prosecute and the board's ability to evaluate physicians' prescribing prac­ tices should be examined. the solution is· to implement guidelines that clearly establish a standard of practice for physicians who are prescribing medication to treat pain, but in doing so, retain the flexibility to adjust with changes in acceptable medical practices. while providing an enforcement mechanism to hold physicians accountable. a. the model policy in 1997, the federation ofstate medical boards ("fsmb .. ) develo~d guidelines for the use of controlled substances for the treatment of pain. 89 the guidelines were established in an effort to encourage state medical boards to have a consistent approach to pain treatment when dealing with controlled substances and to provide a standard that would help ensure proper pain treatment. 90 since its initial creation, the guidelines were re­ vised in 2004 and have been titled "model policy for the use of controlled substances for the treatment of pain., ("model policy'').91 this document has been widely distributed and has been· endorsed by the american acad­ emy of pain medicine, the dea, the american pain society, the national association of state controlled substances authorities, and the national association of attorneys general. 92 the model policy is comprised of licensing agency, http://www.in.gov/plal2485.htm. 88. see discipline by state medical boards creates 'domino effect, ' acog today (am. cong. of obstetricians and gynecologists, d.c.), may/june 2005, at 14, available at http://www.acog.org/-/media/acog%20today/acogtoday0505.pdf?dmc=l&ts=20120411 tl551018826. 89. model policy, supra note 71. 90. !d. at2. 91. ld 92. !d. at 1 710 indiana health law review [vol. 9:2 three sections, including the preamble, guidelines, and definitions.93 the preamble states the policy considerations· for the model policy; the guide­ lines reflect the actual actions physicians ·should take in treating patients with opioids; and, definitions simply define· the medical terms used in the document.94 in addition, pain medicine specialist dr. scott fishman has written a guide that fleshe8 out the model policy and explains how to im­ plement it in daily medical practice.95 the purpose of the policy is to en­ courage proper pain treatment in· a time when undertreated pain is becoming a serious problem by outlining practices that are in compliance with federal and state law.96 . the model policy is designed to communicate certain messages to licensees: that the state medical board views pain management to be important and integral to the practice of medicine; that opioid analgesics· may be necessary for the relief of pain; that the use of opioids for other than legitimate medical purposes poses. a .threat to the individual and society; that phy­ sicians have a responsibility to minimize the potential for the abuse and diversion. of controlled. substances; and that physicians will not be sanctioned solely for prescribing opioid . analgesics for .legitimate medical purposes. this. policy is not meant to constrain or dictate medical decision-making. 97 . those messages are shared by each state medical boards that have adopted the model policy or some variation. arguably, the board has a similar attitude. however, without something published or recorded, such sentiment likely has little meaning 01' force with the physician-community. throughout the united states, forty-nine of fifty-one jurisdictions, includ­ ing washington d.c., have adopted some standard for the use of controlled substances for the treatment of pain through legislation, regulations, or reg­ ulatory policy statements.98 many ofthe states with some type of regulato­ ry policy have utilized either the fsmb's model guideline or policy in whole or in part. 99 the only two states that have yet to adopt any pain re93. id 94. id 95. scorr m. fishman, responsmle opioid presclubjng: a physicians guide (2007). 96. model poucy, supra note 71, at 2. 97. /d. 98. see database of state statutes, regulations, and other o.fficial governmental policies, pain & poucy s1udies group, http://www.painpolicy.wisc.edu/matrix.htm (last visited jan. 17, 2011 ). 99. id. 2012] guidelines for using controlled substances for pain 711 lated policy are illinois and lndiana.100 while this note does not formally endorse any specific guidelines or policy currently in existence, the model policy would be an excellent choice considering its wide range of endorse­ ments and the ease at which the board could adopt it. b. the michigan guideline the state of michigan has taken an extensive approach to dealing with pain management and adopted guidelines for the use of controlled sub­ stances for the treatment of pain ("guidelines") in late 2003.101 in addi­ tion to the guidelines, michigan has adopted similar guidelines for nurses and pharmacists, maintains a website dedicated to pain management, sends a quarterly pain management newsletter to all licensed physicians, has dis­ tributed 70,000 copies of dr. scott fishman's prescribing guide, and sur­ veys licensed physicians on multiple areas including pain management practices.102 suffice it to say, pain management is a priority in michigan. while michigan is achieving many positive results in the area of pain management, its clear and unambiguous law is arguably the most important aspect of its pain management policies. michigan's guidelines are virtual~ identical to the model policy, including .the preamble and defmitions.1 further, michigan's pain management policies and law received an a grade from the wisconsin pain and policy studies group ("ppsg")}04 the ppsg grades every state on the balance and clearness .of its pain manage­ ment laws, regulations, and other regulatory policies.105 the grade is based on provisions that enhance pain management versus the provisions that hin­ der pain management, and a grade of a is only possible when a state's rele­ vant policies completely eschew restrictive or ambiguous language.106 for example, the michigan guidelines state, '"[p ]hysicians should not fear dis­ ciplinary action from the board or other state regulatory or enforcement agency for prescribing, dispensing or administering controlled substances, including opioid analgesics,. for a legitimate medical purpose and in the 100. id 101. id 102. bureau of health professions launches pain management newsletter, mipainmgmt. (mich. dept. of community health. lansing. mich.), fall 2010, at 1-2, available at http://www.michigan.gov/documents/mdch/mipain _management_ 330 510_7.pdf. 103. michigan guidelines for the use of controlled substances for the treatment of pain, mich. bd. of med. (2003), available at http://www.michigan.gov/documents/ mdch_mi_guidelines_91795_7.pdt: 104. pain & poucy studies group, achieving balance in federal and state policy: a progress report card 11 (4th ed. 2008) [hereinafter a progress report card]. 105. see pain & poucy studies group, achieving balance in federal and state policy: a guide to evaluation (5th ed. 2008) (hereinafter a guide to evaluation]. 106. aprogressreportcard,supranote 104, at25. 712 indiana health law review · [vol. 9:2 usual course of professional practice."107 under the ppsg evaluation, this provision enhances pain management because it directly addresses physi­ cians' fear of regulatory scrutiny.108 in contrast, an indiana pharmacy regu­ lation states, "[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose in a reasonable quantity by an individual practitioner acting in the usual course of his professional prac­ tice."109 the ppsg deemed this provision as potentially impeding pain management because it is ambiguous and sets an arbitrary standard for le­ gitimate prescribing. 110 because michigan received thirty-seven positive provisions and zero negative provisions, the ppsg graded michigan with an a, one of only five states to receive the grade.111 indiana received a c-plus grade because its policies and law contain only six positive and two restrictive or ambiguous provisions, including the one noted previously.112 michigan has abundant positive provisions and clearly prom9tes the safe and effective use of con­ trolled substances for pain management; while indiana has very few provi­ sions, positive or negative, that relate to pain management and controlled substances.113 · . in addition to michigan's positive report with the ppsg, they con­ ducted a survey in 2009 for the first time on pain management practices in michigan.114 the survey included information on physician attitudes to­ wards chronic pain treatment, physician pain management education, and reasons why physicians are reluctant to prescribe opioids.115 the most in­ teresting discovery was that when asked to define the greatest barrier to ad­ dressing pain, thirty-two percent of respondents answered that they were afraid their patients would become addicted to opioids, and only five per­ cent stated it was fear of regulatory scrutiny.116 considering all of the liter­ ature and reports that cite fear of regulatory scrutiny as a primary barrier to proper pain treatment, it was the sixth of seven reasons stated as the cause of inadequate pain treatment in michigan.117 while michigan respondents were not asked why they felt this way, one can reasonably conclude that the clarity of the law in michigan has significantly lowered its physicians' con107. mich.bd.ofmed.,supranote 102. 108. aoumetoevaluation,supranote 105, at314. 109. 856 ind. admin. code 2-6-j(a) (2010) (emphasis added). 110. a guide to evaluation, supra note 105, at224. 111. ld. at 314. 112. aprooressreportcard,supranote 104, at 11. 113. as noted previously, indiana bas several provisions relating to controlled sub­ stances, however, those provisions do not involve prescribing practices. 114. mich. dep't of cmty. health, survey of physicians (2009), available at http:/lwww.michigan.gov/documentslhealtbcareworkforcecenter/2009physicianssurveyfin alreport _308082_7.pdf. 115. ld at 12-16. 116. id at 16. 117. id 2012] guidelines for using controlled substances for pain 713 cern over regulatory scrutiny. this seems.particularly sensible because the current theory is that clear and unambiguous pain treatment regulations will reduce physician concern. us thus, michigan physicians feel (1) their pa­ tients will become addicted, (2) their patients fail to properly report pain, (3) lack of physician training and knowledge in pain management, ( 4) in­ sufficient time to asses patient pain, and ( 5) lack of effective medicine are all greater barriers to adequate pain treatment than fear of investigation by authorities.119 as such, where fear of regulatory scrutiny is a minor barrier in michigan, the michigan board of medicine ("michigan board") has tak­ en steps to better educate its physicians by maintaining a website dedicated to pain management and sending a quarterly pain management newsletter to all licensed physicians. it has also distributed 70,000 copies of dr. scott fishman's prescribing guide. even though the michigan board has taken numerous steps to ensure that physicians have the tools to properly treat fcain, its initial goal was to clarify the law on acceptable pain treatment.1 0 that was done largely through michigan's adoption of the guidelines for the use of controlled substances for pain treatment in guideline form, thus reducing physician fear of regulatory scrutiny. c. indiana's attempt to promulgate a rule for using controlled substanc­ es in a pain treatment setting in 2006, the board considered and· came very close to adopting the model policy in almost its entirety.121 on june 1, 2005, the board filed a notice of intent to begin the promulgation process on rules concerning pain management and controlled substances.122 in a letter to the board, multiple indiana physician organizations indicated that the reason for promulgation ''was a reaction to requests made by·physicians for clarification on the use . 123 124 of controlled substances for pam management." the board drafted a 118. see leelyn, supra note 71, at 156. 119. mich. dep't of cmty. health, supra note 113, at 16. 120. the michigan board passed its guidelines for the use of controlled substances for the treatment of pain in 2003; this was before it began its other pain management initia­ tives. fed'n state med. bds., pain treatment poucies, legislation and regulations: board-by-board overview 6 (2012), available at http://www.fsmb.org/pdf/grpol_ pain_management.pdf. see also pain and symptom management, mich. dep't. of licensing and regulatory affairs, http://www.michigan.gov/mdch/0,1607,7-13227417 _ 45947--,00.html (last visited mar. 7, 2012). 121. ind. prof'l licensing agency, mlb timbline for pain management rule, feb. 6, 2006 (on file with the dir. of the ind. med. licensing bd.); see also 28 ind. reg. 3344 (aug. 1, 2005). 122. ld. 123. memorandum from am. coli. of emergency physicians, ind. chapter et al., to the ind. med. licensing bd., (nov. 29, 2005) (on file with the director of the indiana medical licensing board). 124. the proposed rule was drafted by the board in conjunction wi.th an ag advisory 714 indiana health law review [vol. 9:2 proposed rule that looked nearly identical to the model policy except it ex­ cluded the preamble section, replacing every "should" with "shall" and essentially codifying in 844 lac 5 a mandatory version of the model policy without the preamble section.125 the reason for the mandatory standard was the advisory division of the ag, which counsels the board on legal matters.126 the advisory division advised the board that only a regulation should be promulgated to ensure enforceability.127 for example, the model policy states, "the medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse."128 the indiana corollary stated, the medical record shall document the following: (a) the nature and intensity of the pain. (b) current and past treatments for pain. (c) underlying or coex­ isting diseases or conditions. (d) the effect of the pain on physical and psychological function. (e) his­ tory of substance abuse. (f) the presence of one (1) or more recognized medical indications for the use of a controlled substance.129 the proposed rule was published in the indiana register on august 1, 2005.130 at the board meeting on august 26, 2005, a representative from the indiana state medical association ("isma") submitted a letter detailing suggested changes, 131 including changing "shall" back to "should.~'132 the reasoning underlying this suggested change was that "[t]he state purpose of the proposed rule is to establish guidelines. the use of 'shall' indicates a mandate or a limit and could potentially hinder a physician from tailoring treatment to the specific, varying needs of his/her patients."133 at the hearing, the board discussed the concerns submitted by the isma and voted to adopt the proposed rule in its "shall" form by a unaniattorney. ind. med. licensing bd., minutes, oct. 27,2005 (on file with the director of the indiana medical licensing board). 125. 28 ind. reg. 3344 (aug. i, 2005). 126. see ind. code§ 4-22-2-22 (2010). 127. interview with mike rinebold, dir. of gov't relations, ind. state med. ass'n (mar. 7, 2011) (on file with author); mr. rinebold was the director of the board during the 2005-06 rule promulgation process. ind. med. licensing bd., minutes, apr. 28, 2005 (on file with the director of the indiana medical licensing board). 128. 28 ind. reg. 3344 (aug. i, 2005) (emphasis added). 129. id. (emphasis added). 130. 28 ind. reg. 3344 (aug. 1, 2005). 131. there were several suggested changes: modify the definition of addiction, modify the definition of chronic pain, and change all instances of "shall" to should." letter from elizabeth eichhorn to the ind. med. licensing bd. (aug. 26, 2005) (on file with the director of the indiana medical licensing board). 132. /d. 133. /d. 2012] guidelines for using controlled substances for pain 715 mous vote.134 however, after the board sent the proposed rule to the ag for. approval on september 8, 2005, the board received multiple letters of concern from physician organizations, including the indiana chapter of the american college of emergency physicians, indiana academy of family physicians, indiana academy of ophthalmology, indiana osteopathic soci­ ety, indiana psychiatric society, indiana society of anesthesiologists, and the isma. in each of the letters, the primary concern was the mandato~ nature of the proposed rule established by the use of "shall" throughout.1 5· as a result of the l~e medical outcry, the board voted to recall the rule on september 23, 2005, 36 and it held an additional meeting on november 30, 2005 to discuss these concerns.137 although the meeting resulted in some consensus between indiana medical organizations, the isma continued to. oppose any standard in rule form and would only support a guideline form, arguing that a mandatory rule in this area would discourage and burden pain management rather than facilitate it.138 without the support of the isma and others, the board decided to abandon the rule promulgation on february 23, 2006.139 . d. how a guideline would operate under indiana's statutory scheme considering the diversity of the fifty states in the united states, and the fact that policies and legislation regulating physician practice is primari­ ly a state level function, every state is different in the way it investigates, prosecutes, and disciplines physician behavior. in indiana, the board may only discipline physicians who violate the charging statute.140 specifically concerning physician prescribing, the catch all statute, requires some other basis to show the physician failed to keep abreast of current professional 134. ind. med. licensing bd., minutes, aug. 26, 2005 (on file with the director of the indiana medical ucensing board). 135. see letter from elizabeth k. cierziniak on behalfofthe ind. soc'y of anesthesi­ ologists to the ind. med. licensing bd. (sep. 22, 2005) (on file with the director of the indi­ ana medical licensing board); memorandum from am. eon. of emergency physicians, supra note 122; letter from am. eon. of emergency physicians, ind. chapter, et al, to the ind. med. licensing bd. (oct. 25, 2005) (on file with the director of the indiana medical licensing board); ind. prof'l licensing agency, mlb timeune for pain management rule, feb. 6, 2006 (on file with the director of the indiana medical licensing board). 136. 29 ind. reg. 549 (nov. 1, 2005). 137. ind. prof'l licensing agency, mlb timeline for pain management rule, feb. 6, 2006 (on file with the director of the indiana medical licensing board). 138. letter from kevin r. burke, m.d., on behalf of the ind. state med. ass'n to the ind. med. licensing bd. (jan. 16, 2006) (on file with the director oftbe indiana medical licensing board); ind. prof'l licensing agency, mlb timeline for pain management rule, feb. 6, 2006 (on file with the director of the indiana medical licensing board). 139. ind. med. licensing bd., minutes, feb. 23, 2006 (on file with the director of the indiana medical licensing board). 140. ind. code§ 25-1-9-9 (2010). 716 indiana health law review [vol. 9:2 theory and practice.141 a formally adopted guideline in this area would simply provide the basis for invoking the catch all statute. for instance, the ag would charge the physician under the catch all statute, citing the guideline and pointing to the specific deviation. the most effective way for the board to enforce and ensure affected physicians follow the guideline would be for the board to codify a closely worded version of the model policy in 844 1.(\c 5, essentially completing the board's attempt in 2006 with a few changes. specifically, the board should write the model policy into a rule under 844 lac 5, leaving all the permissive characteristics, but where the model policy has a list of actions that physicians should adhere to, the board should require that any devia­ tion be documented in the record with a medical justification for the devia­ tion.142 the board's rule under 8441ac 5 would be identical to the model policy but would read, "any deviation ftom this section shall be document­ ed in the medical record with medical justification for the deviation." this addition to the model policy would add enough teeth to properly enforce the guideline, while also giving physicians enough flexibility to meet each patient's need. such a guideline promulgated in rule form would directly address the concern by the advisory division and the medical community because although physicians would be required to document any deviation, the deviation would not automatically require discipline but allow for flexi­ bility and consideration by the board. under a rule promulgated in this fashion, the board would be forced to consider the guideline under 844 lac 5 because physicians would be required to document and thus highlight any deviation. the board could then properly evaluate physician conduct, and in the event of a deviation ftom the ,policy, the board would retain discretion to discipline or accept the deviation as appropriate where the circumstances warrant.143 this would create a clear and unambiguous law concerning prescribing con­ trolled substances for pain treatment, allow the ag to use an enforceable tool to prosecute inappropriate practices, and grant physicians a flexible standard to meet the varying needs of chronic pain patients. v. the role of a guideline to achieve and balance all interest considering the interests stated previously and the positive impact 141. ind. code§ 2s-l-9-4(a)(4)(b) (2010). 142. see ind. code§ 2s-l-9-4(a)(4)(b) (2010). 143. for example, the model policy states that physicians should adhere to certain ac­ tions in their prescribing behavior and the board will not discipline for deviation when rea­ sonable medical justification is documented. therefore, the model policy is a guide to prescribing rather than a rule and its codification in 844 ind. admin. code s would not alter the guide-like nature of the model policy. rather, adoption would simply require the board to consider it and only impose one rule-like provision: documentation in instances of devia­ tion. see model poucy, supra note 71. 2012] guidelines for using controlled substances for pain 717 michigan's guideline is having in reducing fear of regulatory scrutiny,. the board should adopt a guideline for the use of controlled substances for the treatment of pain. such a guideline will serve two direct and beneficial purposes by (1) providing the ag and the board with a standard under which to evaluate physician prescribing practices, thus facilitating prosecu­ tion and discipline for those who use medicine as a pretext for diversion, and (2) clarifying the law and the board's position in using controlled sub­ stances for pain treatment, which will help reduce physician fear of regula­ tory scrutiny and will facilitate the provision for proper treatment of patients with unremitting pain. a. a guideline will clarify the law and create case evaluation criteria the board should adopt a guideline based on a widely accepted stand­ ard of practice for physicians who prescribe controlled substances for pain treatment, such as the fsmb's model policy of 2004. such a formally adopted or codified guideline will provide the board with a foundational source for what has been determined to be proper standards of conduct. rather than hearing arguments and relying on standards from other states, federal agencies, or private organizations, the board would have its own resource to make such hearings more efficient and consistent. the current state of unclear and nonexistent laws or guidelines is unacceptable·and det­ rimental to medical care. a guideline that represents the board's expecta­ tions and establishes case evaluation criteria would define what unprofessional conduct looks like in a pain management setting.144 this need is heightened by the fact that some standard of care concerning using controlled substances for pain treatment has been adopted in every state save for indiana and illinois. i. the indiana medical licensing board members are not pain manage­ ment specialists one of the major reasons for formally adopting standards of practice for pain treatment or any specialized area of medicine is that board mem­ bers are not experts in every area of medicine. moreover, currently no pain management specialists serve on the board.145 a study completed by diane e. hoffinann and anita j. tarzian revealed that numerous state medical board members believed their adoption of a guideline or policy was "a sig144. see stark, supra note 14, at 612-13; see also leelyn, supra note 71, at 153 ("all states must adopt model guidelines, and medical board members, because of their vast power over health care practitioners, must internalize the model provisions and policies, and scru­ pulously apply them in evaluating physicians' prescription practices."). 145. list of medical licensing board members, ind. prof'l licensing agency, available at http://www.in.gov/pla/2485.htm (last updated apr. 2011 ). 718 indiana health law review [vol. 9:2 nificant aid to them in deciding whether to investigate or discipline·a physi­ cian."146 further, when asked what factors their board would use to evalu­ ate prescribing practices, ''most respondents stated that it· was· a matter of judgment, that it was very fact specific, and often subjective."147 "howev­ er, for those that had established pain management policies or guidelines, these appeared key in determining whether to discipline. significant depar­ tures from the policies, in some cases, could be a basis for discipline.''148 moreover, a survey conducted by dr. aaron gilson, senior researcher for the ppsg, discovered that seventy-five percent of state medical board members felt it was very important for. their state ''to have a policy (i.e., regulation, guideline, or policy statement) for licensees regarding pain man­ agement and controlled substances."149 this statement is·further evidenced by the fact that forty-nine of fifty-one u.s. jurisdictions have adopted some form of statement in either their law or adopted policy.150 even more con­ cerning was the revelation of dr. gilson's survey that many board members held misconceptions about clinical issues. for example, only forty-three percent of board members surveyed were aware that federal law had no jim.; its on the amount a physician can prescribe at one time, and twenty-seven percent "either did not know or incorrectly thoumt that physicians could not legally prescribe methadone for chronic p~in. •• 1 medicine is a wide and diverse discipline, much like the practice of law. simply because someone is an attorney does not mean he is an expert or is even knowledgeable about every area of the law. a wills and trusts attorney would likely be lost in a criminal proceeding involving a homicide. similarly, board members who are physicians may not know the proper methods of pain management, and even if there is one, board membership changes with every new appointee. such is the critical need for some guideline to assist the board in evaluating physician prescribing practices. 2. the case of david and charles chube where prescribing controlled substances for pain is a legally complex 146. hoffinann & tarzian, supra note 67, at 36. 147. id. at37. 148. id. 149. aaron gilson, state medical board members' attitudes about the legality of chronic prescribing to patients with noncancer pain: the influence of knowledge and beliefs about pain management, addiction, and opioid prescribing, 40 j. p ajn & symptom mgmt. 599, 603-04 (2010). 150. database of state statutes, regulations, and other official governmental poli­ cies, pain & pol'y studies grp. (dec. 7, 2011), http://www.painpolicy.wisc.edu/matrix.htm (last visited jan. 17, 2011 ). 151. gilson, supra note 148, at 604; see also leelyn. supra note 71, at 142 ("fifty per­ cent of medical board members surveyed erroneously believed prescribing schedule ii drugs violates the law, contrasted with only twelve percent who correctly understood that physi­ cians may lawfully prescribe opioids to patients with chronic, non-malignant pain."). 2012] guidelines for using controlled substances for pain 719 and medically subjective area,· it is evident that the board is in need of some guideline to follow in making decisions on discipline and on general eval­ uation of physician prescribing practices. to· illustrate this point, consider the case of drs. david and charles chube, who are currently serving federal prison sentences for their inappropriate prescribing practices.152 doctors david and charles chube are brothers who· operated multiple family clinics in munster and gary, indiana, where they frequently treated chronic pain patients using controlled -substances.153 in 2001, a patient of the chubes who had been treated with oxycontin was arrested and charged with know­ ingly and intentionally distributing oxycontin pills.154 in return for a re­ duced sentence, the patient agreed to identify his "suppliers" and testify against them, leading dea officials to the chubes.155 the chubes denied all wrongdoing and argued that they had in ~ood faith prescribed controlled substances for legitimate medical reasons.1 at trial, the government pre­ sented ninety-eight patient files, all of which were examined by two expert witnesses who both testified that the doctors' prescribing practices were not for legitimate medical pwposes.157 further, four of the chubes' patients testified that they lied about their pain solely to obtain the drugs.158 although the chubes and the government presented radically different accounts of the prescribing practices, from trying to serve the public and reduce pain to "pill pushers," the jury found david chube guilty of four counts of unlawful distribution and two counts of health care fraud and ch8rles chube guilty of one count of unlawful distribution.1 59 the most relevant part of this case for the pwposes of this note is not what transpired in federal court but rather t)le actions of the board that occurred under the same set of facts. on april 25, 2005, the ag filed a petition for summary suspension, which would have placed the chubes' indiana medical licenses on.emergency suspension for ninety days, arguing that the chubes posed an immediate threat to the public safety and welfare.160 as evidence for the petition, 161 the ag not only looked to the dea reports but also inde152. see don terey, how two respected gary physicians wound up doing a com­ bined 20 years in federal prison, chi. trm., aug. 31, 2008, magazine, at 8, available at 2008 wlnr 16463427; united states v. chube, 538 f.3d 693 (7th cir. 2008). 153. united states v. cbube, 538 f.3d 693,695 (7th cir. 2008). 154. id. 155. id 156. id 157. id at 697. 158. id at696. 159. id. 160. petition for summary suspension, indiana v. charles r. cbube, 2005 mlb 0023 (ind. med. licensing bd., apr. 25, 2005) [hereinafter charles chube, petition for summary suspension]; petition for summary suspension, indiana v. david d. cbube ii, 2005 mlb 0024 (ind. med. licensing bd., apr. 25, 2005). · 161. the petitions for both cbubes filed by the ag are identical; therefore, all material referencing both petitions will be cited to charles cbube's petition. 720 indiana health law review [vol. 9:2 pendently reviewed the patient medical records and concluded that the chubes ·had prescribed multiple patients "[s]chedule ii and [s]chedule iii drugs with no documentation of medical history, physical examination, di­ agnosis or treatment plans."162 essentially, the ag argued that the chube brothers violated the catch all statute because they failed to adhere to gen­ erally accepted standards of medical record keeping when prescribing con­ trolled substances.163 what may have appeared to be a clear case for s~ suspension actually resulted in the board denying the ag's petition.164 then board president dr. bharat barai stated in a subsequent interview that "[t]he charts that were reviewed at random did not find anythin! wrong .... pa­ tients were referred to pain centers when appropriate."1 when the ag filed the formal complaint, the brothers were charged with violations of, among other things, the catch all statute, to wit 844 lac 5-2-5, which re­ quires practitioners to follow "generally accepted scientific principles, methods, [and] treatments."166 the brothers later agreed to indefinite sus­ pension.pending their federal appeal.167 while the ag found evidence that the brothers had no documentation of medical history, physical examina­ tion, diagnosis, or treatment plans, the board did not find them to be an immediate danger to the public. even though the standard for a summary suspension is higher than in a regular hearing on the merits, 168 the ag pointed to specific instances of failure to prescribe in a certain way, which were clear deviations from the model policy.169 without any reference to how physicians should prescribe controlled substances, the board president simply concluded that the randomly reviewed charts revealed nothing wrong. 170 yet, the chubes' conduct was measured simply against the im­ pressions of the board members, who were not pain management special162. charles cbube, petition for summary suspension, supra note 160, at 2. 163. there is no indication of what specific standard the ag referred to in support if its petition, but it can be assumed that be was relying on 844 lac 5-2-5, which requires practi­ tioners to follow "generally accepted scientific principles, methods, [and] treatments," based on the charges in the subsequently filed compliant. see complaint at 3, indiana v. charles r. chube, 2005 mlb 0023 (ind. med. licensing bd., jun. 28, 2006); complaint at 4, indi­ ana v. david d. chube ll, 2005 mlb 0024 (ind. med. licensing bd., jun. 28, 2006). 164. order denying petition for summary suspension, indiana v. charles r. chube, 2005 mlb 0023 (ind. med. licensing bd., jun. 2, 2005); correction of order denying peti­ tion for summary suspension, indiana v. david d. chube ii, 2005 mlb 0024 (ind. med. licensing bd., oct. 6, 2005). 165. seeterry,supranote l51,at8. 166. 8441nd. admin. code 5-2-5 (2010). 167. see indefinite summary suspension order, indiana v. charles r. chube, 2005 mlb 0023 (ind. med. licensing bd., jan. 31, 2007); indefinite summary suspension order, indiana v. david d. chube ii, 2005 mlb 0024 (ind.med. licensing bd., jan. 31, 2007). 168. see ind. code§ 25-1-9-10 (2010). 169. charles chube, petition for summary suspension, supra note 160, at 1-2. 170. id 2012] guidelines for using controlled substances for p aln 721 ists.171 this note does not suggest that the chubes were "common drug deal­ ers" as alleged by the federal government, 172 but it is clear they were not taking appropriate precautions in prescribing oxycontin. physicians cannot prevent patients from lying to them; however, they also cannot prescribe every new patient oxycontin when the patient claims he is in extreme pain, especially when indiana and the united states are experiencing an epidemic in prescription drug abuse. the ag specifically pointed to the flaws in the brothers' practice, all of which are covered by the model policy, and the board unanimously rejected them because they did not "feel comfortable suspending [the chubes'] licenses."173 because the board did not have any reference or framework as to what were appropriate prescribing practices, it allowed two potentially honest, but careless physicians to retain their li­ censes. with a guideline, the board could have easily seen and addressed the deviation, potentially changing the outcome of their determination.174 the chube brothers case illustrates that, without a policy outlining standards of practice, the ag is left to argue under the theory of generally accepted medical principles, and the board has no real way to evaluate bor­ derline prescribing practices.175 the chubes were not linked to any over­ dose deaths; they kept some semblance of a medical records; and, they did not prescribe to family members.176 commenting on the chubes' federal trial and board hearing, dr. rollin m. gallagher, then president-elect of the american academy of pain medicine, stated the problem was that ''there are not clear standards for prosecutors to follow, just like there are not clear guidelines for physicians to follow in easing pain."177 this is the heart of the interest for the board and the ag. clear standards to prosecute and evaluate are not available. such is a disservice to the ag, the board mem­ bers, and the chubes, who might not have known what a medical record should contain to help prevent diversion and abuse. 171. the participating board members for the chube hearing were richard krejsa, d.o. (geriatric medicine and family practice), stacy lankford, m.d. (urology), bharat barai, m.d. (hematology and oncology), ralph stewart. m.d. (ophthalmology), william beeson. m.d. (otolaryngology and cosmetic sw"gel')'), ms. barbara malone (consumer member). ind. men. licensing bd., minutes 17 (apr. 28, 2005). 172. united states v. chube, 538 f.3d 693, 696 (7th cir. 2008). 173. ind. med. ll<;:ensing bd., minutes (apr. 28, 2005). 174. see hoffinann & tarzian, supra note 67, at 17 (a surveyed board member ex­ plained, "we have pain management guidelines that we've published, and it's easy to com· pare a physician's behavior to those guidelines, but i'd say we refer to a pain management expert in about 20 percent of the investigations, but they [also] use our guidelines."). 175. see hoffinann & tarzian, supra note 67, at 12 (surveyed medical board membe(s explicated, "the board's attitude has changed; now we have pain management guidelines and have an established way of determining if a physician is deviating from those guidelines. we're more aware of the need for adequate pain management and how that should be docu­ mented."). 176. see united states v. chube, 538 f.3d 693. 177. terry,supranote 151. 722 indiana ileal til law review [vol. 9:2 b. clear standards put physicians on notice as to proper prescribing practices in addition to a guideline providing an evaluation and prosecution tool for the board and the ag, a clear standard would communicate to physi­ cians what is expected of them when it comes to prescribing opioids for pain treatment. the ability of physicians to know the board's expectations serves two different needs: (1) so the physician may prescribe without fear of state investigation, and (2) so that when there is an investigation, the physician may adequately defend himself. 1. a guideline will alleviate fear of regulatory scrutiny when physicians are aware that their state medical board has a clear and published standard of practice, their concerns about state investigation will likely recede because they will know what the state expects them to do. as noted in the 2009 michigan survey, michigan physicians report that they do not fear regulatory scrutiny, which is directly related, at least in part, to the fact that michigan has clear policies and law on prescribing controlled substances for pain treatment.178 the model policy was developed to "clar­ ify the board's position on pain control, particularly as related to the use of controlled substances, to alleviate physician uncertainty and· to encourage better pain management. "179 physicians who face investigation and charges will potentially pay a high price regardless· of whether discipline is handed down, including fi­ nancial costs, damage to reputation, loss ofbusiness, and other consequenc­ es.180 physicians are aware of the costs, and in an effort to avoid investigation and charges, manr will alter their prescribing or avoid certain types of patients completely.18 a guideline, especially when coupled with broad dissemination and communication activities from the board, can al­ leviate the tension between physicians and the fear that their prescribing practices will lead to damaging scrutiny. if the guideline states that the medical chart should contain a medical history, patient examination, and a medical reason for the prescription, then the physician will know what the board and the ag will be looking for in a chart should a patient complain. further, if one of the provisions is not practical or possible for the specific patient, the physician will be aware of his deviation from the guideline and can document the reasons for such deviation. without knowing the evalua­ tion· criteria used by the board, physicians will continue to undertreat pain 178. mich. dep't of cm1y. health. supra note 113, at 16. 179. modelpolicy,supranote 71. 180. johnson, supra note 65, at 1029. 181. /d. at 1030. 2012] guidelines for using con'irolled substances for pain 723 and refrain from subjecting themselves to unwarranted investigation.182 when physicians have a published guide from the board, they can practice without fear because they will know the parameters of acceptable prescrib­ ing actions and will have a set of expectations with which they can comply. this is the core of barriers to adequate pain management, which the board has the direct and sole ability to address and alleviate.183 2. a clear guide will enable proper defense in addition to alleviating fear of regulatory scrutiny, a guideline will give physicians a clear standard they can use to defend their practices. without a clear standard, physicians are unable to adequately defend them­ selves because there is no clear means under which to defend their actions. they are left to justify their prescribing behaviors under a standard of gen­ erally accepted practice, as is the ag. while the ag is in the same position from an evidentiary perspective, the common outcome is for the physician to settle. on october 30, 2009, the. ag filed a complaint against the license of dr. michael punnett.184 from march 2007 through november 2008, dr. punnett treated a patient for pain using different medication including percocet, a schedule ii controlled substance, lortab, and norco, both schedule iii controlled substances.185 throughout the course of the treat­ ment, the patient would ask for increased doses, decreased doses, early re­ fills, and new medication because the medication had either been lost, stolen, or flushed by his wife.186 on numerous occasions, dr. punnett re­ jected the patient's request for early refills or refused to ~rescribe anything more until the patient underwent another physical exam. 87 however, dr. punnett did prescribe different doses of medication at the patient's request several times-including when he claimed that he had lost his medication with his luggage, or that his wife had flushed them down the toilet .188 in april2008, dr. punnett noted in the patient's medical chart that the patient needed to be seen because of suspicious refill requests. dr. punnet exam­ ined the patient the next day, but there was nothing documented in the med182. shannan w. leelyn, failures in pain management: the collision of law and medicine, 27 t. jefferson l. rev. 133, 154 (2004) (stating "[u]ntil [a] line is drawn and physicians are able to understand the limitations imposed on them by law, physicians will continue to under-treat chronic pain"). 183. gilson et al., supra note 15, at 119. 184. complaint, in the matter of the license of michael a. punnett, 2009·mlb 0032 (ind. med. licensing bd., oct. 30, 2009). 185. ld. 186. id. 187. id 188. id 724 indiana health law review [vol. 9:2 ical record as to what was discussed.189 after being notified by the patient's wife that the patient was lying about losing his medication, dr. punnett conducted a follow-up examination and discovered that the patient was tak­ ing eight to ten itrdrocodone a day and had been admitted to a behavioral health program.1 during the meeting, dr. punnett noted in the medical chart that opioids should not be given and the patient should potentially be discharged from the practice.191 however, dr. punnett prescribed one last dose of norco for the patient, and there was no mention in the medical chart as to a reason.192 the ag charged dr. punnett with multiple violations of prescribing to a known addict, failure to keep abreast of current theory or practice, and failure to take proper precaution to identify and address the patient's addic­ tion.193 rather than take his chances with the board, dr. punnett settled and simply received a letter of reprimand from the board.194 had this case been presented before the board, the outcome is speculative at best. dr. punnett did recognize that there were potential problems with the pa­ tient and brought him in for examination. however, he continued to pre­ scribe for pain for reasons unknown. pain management is a tricky and extremely subjective practice.195 maybe the patient really was in extreme pain, or maybe the patient, when he confessed he had a problem and was in a rehab program, truly needed the prescription in the medical judgment of dr. punnett. the point is, dr. punnett chose not to defend and place him­ self at the mercy of the board. in ,the end, he settled for a potentially lesser discipline and walked away. had there been some guidelines as to what the board considered appropriate practice, dr. punnett would have been able to properly defend his practice and fight the charge before the board while a letter of reprimand does not technically restrict his ability to practice, it is public record, and other physicians may think twice before referring pa­ tients to him-in fearing that they might be implicated should something worse surface in the future. the punnett case illustrates the inability of physicians to adequately defend themselves and the propensity of a physician to settle rather than defend. this is an issue for the ag as well but presents a greater disad­ vantage to physicians because physicians stand to lose much more from an unfavorable outcome than does the ag. a guideline setting out evaluation 189. id. 190. id. 191. id. 192. id 193. id 194. stipulated findings of fact, stipulated conclusions of law, ultimate conclusions of law, and order, in the matter of the license of michael a. punnett, 2009 mlb 0032 (lnd med. licensing bd., june 30, 201 0). 195. jeffrey wishik, chronic pain: medical and legal aspects, 53 r.i. b. j. 23 (2004) {discussing the subjective nature of pain and ways to treat it appropriately). 2012] guidelines for using controlled substances for pain 725 criteria would enable the physician to better evaluate his status under the guideline and thereby avoid an unwanted settlement because he could po­ tentially present his case before the board with the confidence and the knowledge that he followed the board's expectations. had there been a guideline, dr. punnett may have made a special notation as to his medical reasons for prescribing,norco to the patient after he discovered there were problems. without a standard, many cases are too unclear, causing physi­ cians to settle since at least then they have some control over the out­ come!96 c. the patients will receive better treatment when physicians do not fear regulatory scrutiny and can properly de­ fend complaints, patients with chronic pain ultimately are the beneficiaries. patients will now have more confident doctors who can not only aggres­ sively and effectively but also responsibly and safely treat their pain. moreover, the general public benefits from more effective and consistent treatment by physicians prescribing controlled substances for pain treatment because good doctors are duly recognized, and those who contribute to pre­ scription drug abuse are more easily identified and successfully disciplined. vi. the case against a guideline li1 spite of all the benefits to be gained by adopting a guideline for the use of controlled substances for pain treatment, there are those who disap­ prove of the proposal for various reasons. however, despite the arguments, a guideline with an enforceability mechanism is in the best interest for all concerned. a. there is no enforceability with a guideline the argument against a guideline as advocated by the ag's advisory division is that a guideline lacks teeth or enforceability and ultimately will be useless, or even more problematic and confusing to implement. only statutes and regulations which are promulgated by the board can be en­ forced, and a guideline would give a false sense of enforceability, ultimate­ ly meaning nothing when the board actually contemplates discipline for physician conduct. it is important to note that the board would not disci­ pline under the guideline, but rather; it would discipline under the catch all statute citing the guideline as evidence of the physicians' inappropriate 196. hoffmann & tarzian, supra note 67, at 36 ("[standards] serve to reassure physi­ cians that they will not be disciplined for overprescribing opioids to patients with chronic pain if they conform to standards of practice and state pain policies."). 726 indiana health law review [vol. 9:2 practices without proper documented justification. in essence, the guideline would take the place of"generally accepted standards of practice." this argument is the main reason for the board's failed attempt in 2005 and 2006 to adopt a standard because the board and the ao wanted a mandatory regulation, and physician organizations wanted a guideline~ the drafters of the proposed rule, including an ao advisory division attorney, changed all of the "shoulds" to "shalls" to ·create an inflexible practice standard with the force of law. the indiana medical associations complete­ ly opposed this effort, claiming that a hard and fast rule in the area of pain management would restrict medical decision-making and ultimately impair patient pain care.197 the medical associations argued that certain physi­ cians, such as emergency department physicians who use opioids, would fall under the requirements of the proposed rule and would technically be in violation when they did not complete a full medical history or devise a treatment plan.198 · · · despite the advisory division's enforceability concern, the proposed solution that the board should codify a version of the model policy with a requirement for documented deviation, gives the standard teeth. to enforce because physicians would be required to follow·the guideline or document reasons for deviation. that way, the board would be in a position to evalu­ ate the practices against the guideline and decide whether to accept justifi­ cations for deviation as legitimate. this solution creates a mandatory provision with maximum flexibility for physicians to treat pain. as such, medical organizations should accept the permissive nature of this scheme, and those concerned with being able to enforce the standard will have the means to require compliance or documented deviation by physicians. however, even if the board rejects the proposed scheme and adopted a guideline similar to the fsmb's model policy, the ppso has stated, "while guidelines do not have binding legal force,. they may help those reg­ ulated by an :~ency to better understand the regulating agency's standards ofpractice."1 both the indiana medical associations and the ppso's con­ cern is further substantiated by the following statement:· · doctors are asking for reassurance, not more rules or laws. even the best intentioned of them [laws and rules], create only more fears in the minds of doctors trying to do their best, and place more ammunition in the hands of lawyers and regulators! doctors will avoid the treatment of pain, so as not ·to take the 197. see letter from kevin r. burke, m.d. on behalf of the ind. state med. ass'n. to the ind. med. licensing bd. (jan. 16, 2006) (on file with the dir. of the ind. med. licensing bd.). · 198. letter from am. coll. ofemer. ph:ysicians, supra note 134. 199. aguidetoevaluation,supranote 105,at§2. · 2012] guidelines for using controlled substances for pain 727 chance of "not being in compliance" with some minor detail. 200 · if the board fornull.ly adopts a guideline, they are likely to use it when evaluating physician conduct as if it were binding because it has the board's recognition as a standard of practice. representatives of other medical boards that have guidelines or some other standard of practice have stated: . [i]f we don't have good documentation, if it doesn't appear that the physician's following the board's guide~s with respect to prescribing for pain, then we'll investigate ... forthe most part we adhere to [our pain guidelines] ... ,[we've made] a lot of progress ... . we set the minimum standard of care in any· state, documentation, ·informed consent, proper referral, etc., so we look for. that . . . the general policy that was ma.d.e known to physicians is that we leave pre­ scribing and .pain management control issues to their professional judgment, but if there is a complaint, they better have proper. docu:mentation, such as in-. formed consent, history and physical, monitoring, etc_20l .. a purely nwtdatory regulation simply should not be passed in such a subjective area. the board must retain some discretion to evaluate physi­ cian conduct be<,:ause the goal is not to discourage physician conduct, but to encourage it without the restrictions inherent in mandatory standards. moreover, if the board were to adopt the model policy or some variation, it would likely only be a matter of time before indiana medical associations also adopted the guideline as a clinical standard of practice for the profes­ sion. thus, physician deviation, especially absent docw:pented justification, could also become subject to medical malpractice in civil cases?02 in other words, board members are likely to use it to enforce the charging statute, 200. johnson, supra note 65, at 1016. 201. diane e. hoffinann & anita j. tarzian, achieving the right balance in oversight of physician opioid prescribing for pain: the role of state medical boards, 31 j.l. med. & ennes 21, 10 (2003). 202. it is possible that when the board adopts or codifies a guideline or policy for pre­ scribing practices for pain management, other medical associations may do the same as a. result of the boards initial adoption. this is especially true of the model policy because the isma has already given it ~pport, and where such a policy becomes a standard of practice in the medical profession rather than just for the license purposes. an unjustified violation would become subject to civil liability. see memorandum from am. coli. of emer. physi­ cians, supra note 122. 728 indiana health law review [vol. 9:2 and physicians are likely to follow it, particularly when it is considered a standard of practice for the profession. though the proposed solution best meets the enforceability concern. a formally adopted guideline will also garner compliance by the board and medical community. that is all the enforceability that is needed. b. restricts the practice of medicine in any case that a new law or guideline is developed, it will be argued that the practice of medicine will be restricted. this is true. and a guideline will restrict pain management to some degree because physicians will not have unfettered discretion to treat as they see fit "pain management physi­ cians are restricted by these guidelines that the medical specialists claim do not make sense medically and impede the proper treatment of patients' needs regarding pain.'.2°3 however, the degree that it is restricted is only to the extent that the physician has a plan of action. keeps good documentation, and prescribes responsibly. dr. punnett would not be allowed to prescribe to a potential addict without clear documentation as to why, and the chube brothers would have been forced to take better precautions to prevent diversion and abuse. while this may be considered restrictive, it is minimal at worst and necessary to advance societal goals in preventing prescription drug abuse. further, the whole purpose here is that any deviation is a clear deviation from accepted standards, and the guideline will not. automatically impose judgment as a rule would, but would instead allow for deviation where good cause is docuinented. so, if dr. punnett prescribed after he knew of his pa­ tient's abuse problems, he could document that the patient needed the med­ ication to survive his pain through the night and could argue that before the board. a goal that is reinforced by a guideline is to hold physicians account­ able for their practices. the guideline looks for documentation, treatment plans, informed consent, and other items that accomplish accountability. as said before, deviation is allowable with documented justification, and the board still retains discretion to adjudicate subjective physician conduct. moreover, a formally adopted guideline is malleable and can be changed without the rigors of the rule-making process. ·when medical standards evolve, the guideline can be modified. this solution avoids unintended consequences because ambiguous standards and archaic requirements can be remedied more easily than a statute or regulation. even though the pro­ posed solution of codifying a version of the model policy does not strictly 203. bhavani s. reddy, the epidemic of unrelieved pain: the ethical, societal, and regulatory barriers facing opioid prescribing physicians, 21 j. legal med. 427, 438 (2006). 2012] guidelines for using controlled substances for pain 729 fall under this malleability benefit, its requirement for documented justifica­ tion is malleable to the point that the justification can reflect new legitimate advances in pain management practices. c. specific standards are not necessary to achieve physician discipline substandard care in prescribing practices to treat pain with controlled substances is currently established in indiana without guidelines. the ag was able to successfully prosecute dr. edwards, dr. foley, and others in the past year without· guidelines. while that is true, as explained before, the physicians disciplined are either obviously prescribing with substandard care or are violating another specific provision. further, in borderline cases such as those of the chube brothers and dr. punnett, the ag had to rely on a settlement or an agreed order. the concern is whether the discipline will be as accurate, efficient, or consistent as it would be with a clear standard, and whether the ag is able to prosecute borderline cases, including those who are diverting with medicine as a pretext. whether or not a guideline is necessary, it would undoubtedly make the ag's job easier and more effi­ cient to be able to point to specific deviations from a policy than to argue the physician deviated from generally accepted standards of practice. d. patient concern of required documentation in some instances, patients become uncomfortable with restrictions and guidelines under which their doctors require compliance contracts in controlled substance settings. 204 patients feel they are not being trusted and are given an undesirable ultimatum to strictly comply or be dropped by their physician. 205 while this is a complex clinical issue beyond the scope of this note, society's problem with prescription drug abuse is an epidemic in our country. although this concern is legitimate and should be handled with delicacy by the physician, it is not a sufficient enough concern to out­ weigh the benefits to patient care achieved by a guideline. vii. conclusion the board has a duty to protect the citizens of indiana, both from in­ adequate pain management and from diversion and abuse of controlled sub­ stances. adopting or codifying a guideline would create a standard by which physician conduct could be evaluated and properly disciplined. a guideline also would help alleviate a major barrier to effective pain man204. kevin b. o'reilly, pain contracts can undermine patient tnjst, critics say, amednews.com (dec. 27, 2010), bttp://www;ama-assn.orglamednews/2010/12/27/ prsb 1227 .htm. 205. id 730 indiana heal1h law review [vol. 9:2 agement and allow the board to closely evaluate physician practice, which accomplishes both the interests in protecting patients and the public at large. the board is the only entity in indiana with the authority to adopt a guideline and should do so not only because it is its duty, but also to ac­ complish the valuable clinical and regulatory objectives that a guideline is intended to address. cosmetic neurocognitive enhancement and healthcare providers tracy d. gunter m.d.*∗ i.introduction .................................................................. 730 ii. neurocognitive enhancement in health care ..... 732 iii.requests ...................................................................... 737 a. neuromyths facilitating requests .......................... 737 b. direct-to-consumer advertising as a driver of patient requests......................................................... 739 c. so what is it that people do (and do not) want to alter? ............................................................... 741 iv. responses: provider issues ...................................... 745 a. models of provider-patient interactions ................... 746 b. provider attitudes about enhancement .................. 749 c. availability of enhancing drugs (off-label prescribing) ..................................................................... 751 d. currently available enhancing drugs .................... 753 1. schedule ii drugs .................................................. 753 2. schedule iv drugs ................................................. 756 3. otc drugs ............................................................. 758 4. other considerations .............................................. 761 v. recommendations for providers and systems ....... 763 vi. conclusion .................................................................. 767 * associate professor clinical psychiatry, division of forensic psychiatry, department of psychiatry, indiana university school of medicine. adjunct professor of law, indiana university mckinney school of law. the author wishes to thank alexia torke, md, phd and nicolas terry, llm for valuable comments on an earlier draft of this manuscript. http://dx.doi.org/10.18060/3911.0007 730 indiana health law review vol. 12:2 i. introduction cosmetic neurocognitive enhancement is the use of prescription stimulant drugs to enhance cognitive functions such as attention, concentration, and memory beyond normal limits in healthy people. 1 interest in cosmetic neurocognitive enhancement has grown as treatments to improve cognition in individuals who suffer from illnesses that impact cognition have become more prevalent, safe, and effective. 2 painted partly as self-improvement and partly as disease prevention, the idea that a person could be better than well by chemically manipulating the brain captivates the imagination.3 also sometimes called brain doping, 4 cosmetic prescribing, or wish-fulfilling medicine, the prescription medications most commonly requested for cosmetic purposes are stimulant medications regulated as schedule ii controlled substances such as methylphenidate (e.g. ritalin and concerta) and dextroamphetamine (e.g. adderall and the prodrug vyvanse).5 1 tsee leng choya, cognitive-enhancing drugs in the healthy population: fundamental drawbacks and researcher roles, 2 cogent psychol. 1 (feb. 2015), available at http://www.tandfonline.com/ doi/pdf/10.1080/23311908.2015.1011579. 2 anjan chatterjee, cosmetic neurology and cosmetic surgery: parallels, predictions, and challenges, 16 cambridge q. healthcare ethics 129 (2007), available at http://ccn.upenn.edu/chatterjee/ anjan_pdfs/cosmeticneuro_surgechqe2007.pdf [hereinafter chatterjee, cosmetic neurology]. 3 davi johnson thornton, brain culture: neuroscience and popular media (2011). 4 brendan maher, poll results: look who’s doping, nature (apr. 10, 2008), http://www.nature.com/news/2008/080409/full/452674a.html; regula ott et al., neuroenhancement – perspectives of swiss psychiatrists and general providers, 142 swiss med wkly. 1 (nov. 27, 2012). 5 scott ewing & jerrold rosenbaum, phrenotropics: make up for the mind, 2 harvard rev. psychiatry 49 (1994); anjan chatterjee, cosmetic neurology: the controversy over enhancing movement, mentation, and mood, 63 neurology 968 (2004) [hereinafter chatterjee, controversy]; anjan chatterjee, the promise and predicament of cosmetic neurology, 32 j. med. ethics 110 (2006) [hereinafter chatterjee, promise and predicament]; eva asscher et al., http://dx.doi.org/10.1080/23311908.2015.1011579 http://dx.doi.org/10.1017/s0963180107070156 http://dx.doi.org/10.1038/452674a http://dx.doi.org/10.3109/10673229409017116 http://dx.doi.org/10.1212/01.wnl.0000138438.88589.7c http://dx.doi.org/10.1136/jme.2005.013599 2015 cosmetic neurocognitive enhancement 731 the place of cosmetic neurocognitive enhancement in health care is controversial. traditional definitions of health care stress the goals of diagnosis and treatment of the ill. using this definition, cosmetic neurocognitive enhancement would not be considered health care because the requestor is not ill or disabled. however, the world health organization (who) has much broader definitions of health and health care6 that would easily encompass the practice of cosmetic neurocognitive enhancement if the practice may be defined as the prescription of medication for promotion, maintenance, or restoration of the mental or social well being of the individual. similar to professional opinion, popular opinion is divided on the legitimacy of both the request for cosmetic neurocognitive enhancement and the provider response to the request. some seekers of cosmetic neurocognitive enhancement are “early adopters” of a “successful” technology, 7 and portrayed as earnest students trying to weather an educational system that does not meet their individual learning needs.8 a slightly less complimentary term, requestors of neurocognitive enhancement are sometimes referred to as “non-medical” users of highly regulated controlled substances. at the most pejorative end of the spectrum, some authors characterize all users of stimulants for cosmetic neurocognitive enhancement as addicted to the substances and/or guilty of “cheating.” wish-fulfilling medicine in practice: a qualitative study of physician arguments, 38 j med. ethics 327 (2012). 6 health is “the state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity” and health care is “services provided to individuals or communities by health service providers for the purpose of promoting, maintaining, monitoring or restoring health.” who centre for health development, a glossary of terms for community health care and services for older persons, 5 ageing and health technical report (2004), available at http://www.who.int/kobe_centre/ageing/ahp_vol5_glossary.pdf. 7 see, e.g., henry greely et al., towards responsible use of cognitive-enhancing drugs by the healthy, 456 nature 702 (2008). 8 nuffield counsel on bioethics, novel neurotechnologies: intervening in the brain 162-91 (nuffield counsel on bioethics ed., 2013), available at http://nuffieldbioethics.org/wp-content/uploads/ 2013/06/novel_neurotechnologies_report_pdf_web_0.pdf. http://dx.doi.org/10.1136/medethics-2011-100103 http://dx.doi.org/10.1038/456702a 732 indiana health law review vol. 12:2 providers are also portrayed at the extremes in the popular media. providers who do not offer or provide cosmetic neurocognitive enhancement seem unfeeling, egotistical, paternalistic, and rigid. when providers do prescribe medications for cosmetic enhancement purposes (i.e. without clear evidence of illness), commentators characterize them as pawns of drug companies, medicalizing the human plight, ignorant of side effect, overly idealistic about benefits of drugs, and/or contributing to the problems of drug addiction and diversion. in the sections that follow, i argue that the definition and scope of health care allows for the practice of cosmetic neurocognitive enhancement, that there is great variability in the population defined as well, and that sufficient indeterminacy exists so that a more nuanced view of cosmetic neurocognitive enhancement is necessary to inform policy and practice. such a view respects the autonomy of both providers and patients, while balancing provider responsibilities such as beneficence, non-maleficence, and social justice. i then review drivers of patient requests for enhancement and physician experience with requests prior to concluding with a model practice guideline. i constrain the discussion to currently available medication because the assessment of risks and benefits of medication should be driven by the best empiric evidence available.9 ii. neurocognitive enhancement in health care although some definitions of health care revolve around the prevention and treatment of disease,10 the who takes a broader view of health, equating it with optimal well 9 a similar argument is made by smith and farah. m. elizabeth smith & martha j. farah, are prescription stimulants “smart pills”? the epidemiology and cognitive neuroscience of prescription stimulant use by normal healthy individuals, 137(5) psychol. bull. 717 (2011). 10 see, e.g., health, merriam-webster dictionary, http://www.merriam-webster.com/dictionary/health (last visited feb. 13, 2015); francis fukuyama, our posthuman future: consequences of the biotechnology revolution 206 (picador ed., 1st ed. 2002) (“the original purpose of medicine is, after all, to heal the sick, not turn healthy people into gods.”). http://dx.doi.org/10.1037/a0023825 2015 cosmetic neurocognitive enhancement 733 being. 11 with only 17% of individuals functioning optimally,12 health care activities are applicable to 83% of the population. in addition to the correction of abnormal bodily function to relieve symptoms, mental, emotional, and social factors are all considered equally important in this definition. other definitions of health emphasize the capacity of the individual to self-manage and adapt to the environment. 13 cosmetic neurocognitive enhancement represents one way in which an otherwise well individual may choose to adapt to a challenging environment through the use of the services of a health care provider. from an ethical perspective, utility arguments favor cosmetic practices,14 placing high value on the self-maintenance of health, enhancement of self-esteem, and improved social functioning as potential goods meriting inclusion of cosmetic enhancement as a health care activity. from a practical standpoint, the care of the well is far from remote to the practice of health care. medical providers hear patient requests for enhancement in consultation rooms across the united states every day with over half of providers receiving monthly requests for enhancement and more than 10% receiving daily enhancement requests.15 in addition to hearing requests for enhancements, providers offer enhancements to patients. approximately one third of providers offer enhancements to patients on at least a monthly basis and over 7% offer enhancements to patients on a daily basis.16 11 world health org., basic documents 1 (world health organization ed., 48th ed. 2014), available at http://apps.who.int/gb/bd/. 12 u.s. dep’t of health and human servs., mental health: a report of the surgeon general (howard h. goldman et al. eds., 1999), available at http://profiles.nlm.nih.gov/ps/retrieve/ resourcemetadata/nnbbhs. 13 machteld huber et al., how should we define health?, bmj (july 26, 2011), http://www.bmj.com/content/343/bmj.d4163. 14 chatterjee, cosmetic neurology, supra note 2, at 129-37. 15 timothy d. hotze et al.,“doctor, would you prescribe a pill to help me . . . ?” a national survey of physicians on using medicine for human enhancement, 11 am. j. bioethics 3-13 (2011) [hereinafter hotze et al., doctor]. 16 id. http://dx.doi.org/10.1136/bmj.d4163 http://dx.doi.org/10.1080/15265161.2011.534957 734 indiana health law review vol. 12:2 cosmetic surgery is an example of health care offered to the well for the purpose of enhancement. both cosmetic neurocognitive enhancement and cosmetic surgery alter the body of someone without known illness, despite risk of significant side effects.17 both have personal satisfaction as an unclear and difficult-to-measure endpoint. and both involve the use of limited resources for cosmetic enhancement despite significant ongoing need for restorative and rehabilitative services. 18 when effective, both processes tend to confer social advantage and thus potentially widen the gap between the enhanced and unenhanced. similar to cosmetic surgery, third party payment for cosmetic neurocognitive enhancement is unlikely, so the resource is limited to individuals able to pay for it. in some ways, however, the practice of cosmetic neurocognitive enhancement is more complicated and less certain than physical enhancement. individuals requesting cosmetic neurocognitive enhancement are likely to feel stressed and dysphoric at the time of presentation,19 which is a well-known risk factor for poor outcomes following cosmetic procedures. in contrast, individuals usually deemed candidates for cosmetic procedures are “healthy individuals with a positive outlook and realistic expectations.”20 other people at risk for a poor outcome following a cosmetic procedure include those with unrealistic expectations of the intervention, who view altering the body as “fixing” a life problem. in the case of neurocognitive enhancement, all requests involve a perceived need by the requestor to “fix” a mismatch between the cognitive demands imposed by the environment and the 17 cosmetic surgery is the reshaping “of normal structures of the body in order to improve appearance and self-esteem.” cosmetic procedures, am. soc’y plastic surgeons, http://www.plasticsurgery.org /cosmetic-procedures.html, archived at http://perma.cc/n8zd-gqe2 (last visited may 20, 2015). 18 chatterjee, cosmetic neurology, supra note 2, at 129-37. 19 genevieve verdi et al., non-medical prescription stimulant use in graduate students relationship with academic self-efficacy and psychological variables, j. attention disorders (apr. 22, 2014). 20 cosmetic procedures, supra note 14. http://dx.doi.org/10.1177/1087054714529816 2015 cosmetic neurocognitive enhancement 735 resources possessed by the individual. poor outcomes are then more likely because requestors are so focused on the goal that they almost invariably inflate potential benefit and minimize risk.21 the effectiveness of most cosmetic surgery is measurable in physical and objective terms, while satisfaction with that change is more subjective. however, the effectiveness of cosmetic neurocognitive enhancement is only measured by subjective impressions of changes in cognition and the associated sense of satisfaction, all which is highly subjective and reliant upon the mood of the person evaluating the past experience at the time the person is asked to reflect on it. while most cosmetic surgery involves a one-time procedure of greater risk than taking a prescribed stimulant as directed, cosmetic neurocognitive enhancement involves chronic treatment with drugs with unclear chronic effects. the brain is the most poorly understood organ in the body and brain pathways are highly interconnected so unintended effects may occur in an unpredictable fashion. stimulants intended to improve cognition, for example, may also induce mood changes, irritability, anxiety, impulsivity and problems with reality testing. in addition to the direct risks of the individual medications, altering the brain likely also impacts the person’s perception of self, others, and the intervention. at the extreme, the substance may potentiate vulnerability for addiction in the user such that the user values drug effects over social and occupational activities and relationships. strategies to optimize response and reduce risk at the individual level are equally relevant for cosmetic surgery and cosmetic neurocognitive enhancement. these include setting stable healthy habits as a precondition of cosmetic treatment, treating diagnosable conditions before moving to cosmetic enhancements, ensuring sufficient resources to maximize compliance with recommendations, and requiring financial accountability. 21 see, e.g., alan d. desantis & audrey curtis hane, “adderall is definitely not a drug”: justifications for the illegal use of adhd stimulants, 45 substance use & misuse 31 (2010). http://dx.doi.org/10.3109/10826080902858334 736 indiana health law review vol. 12:2 at the societal level, cosmetic neurocognitive enhancement clearly poses more challenges than cosmetic surgery. prescription drug abuse is a major public health problem and problematic use of stimulants is rising in all adult populations.22 personal misuse of medications may result in increased health care utilization and cost due to accidents and other complications in the individual who escalates dose and uses prescribed stimulants with other substances. harm to others may occur when the individual does not properly store or dispose of medications, or diverts them to individuals to whom they were not prescribed. sixty-one percent of college students diagnosed with attention deficit hyperactivity disorder (adhd), a condition typically treated with prescribed stimulant medications, reported diverting stimulant medications.23 diversion may be more common in non-medical users of stimulant medications who require low doses on an intermittent basis in order to achieve the desired effects.24 while the diversion of stimulant medications in the united states is a problem, the united states is by far the leading supplier of stimulants worldwide and it is unlikely that the global amphetamine issue can be addressed while stimulant production and consumption is increasing.25 up to 90% of the amphetamines sold through illicit means for recreational use are products of u.s. pharmaceutical firms, 22 steven m. berman et al., potential adverse effects of amphetamine treatment on brain and behavior: a review, 14 molecular psychiatry 123 (2009). 23 laura m. garnier et al., sharing and selling of prescription medications in a college student sample, 71 j. clinical psychiatry 262 (2010). 24 alan d. desantis et al., illegal college adhd stimulant distributors: characteristics and potential areas of intervention, 48 substance use & misuse 446 (2013). 25 nicolas rasmussen, america’s first amphetamine epidemic 1929–1971: a quantitative and qualitative retrospective with implications for the present, 98 am. j. pub. health 974 (2008). “any effort to deal harshly with methamphetamine users today in the name of epidemic control, without touching medical stimulant production and prescription, is as impossible practically as in 1970—and given historical experience, even more hypocritical.” id. http://dx.doi.org/10.1038/mp.2008.90 http://dx.doi.org/10.1016/s0084-3970(10)79404-4 http://dx.doi.org/10.3109/10826084.2013.778281 10.2105/ajph.2007.110593 2015 cosmetic neurocognitive enhancement 737 and half of the nation’s illicit stimulant users consume pharmaceutical amphetamines only.26 although amphetamines were over the counter medications (otcs) for forty years, and have been increasingly popular prescribed drugs, recognition of harms to public health resulted in an international resolution calling for the development of less risky substances capable of producing the same therapeutic benefit.27 manufacturers have made progress in producing less divertible alternative forms of stimulant medications such as patches and longacting formulations, an effective stimulant medication without some addiction liability does not yet exist. it is therefore incumbent on the provider to use the lowest possible dose, for the shortest possible time, with regular follow-up for the duration of medication provision to mitigate both individual and societal harm. iii. requests the drives for wellness and enhancement are not new.28 human beings have attempted to improve and adapt for centuries. in this section i explore some of the recent drivers for requests for cosmetic neurocognitive enhancement and the expectations of requestors. a. neuromyths facilitating requests there are a number of myths about brain structure and function that facilitate undue faith in cosmetic 26 shaheen e. lakhan & annette kirchgessner, prescription stimulants in individuals with and without attention deficit hyperactivity disorder: misuse, cognitive impact, and adverse effects, 2 brain and behav. 661 (2012). 27 u.n. convention on psychotropic substances, vienna, jan. 11feb. 21, 1971, resolutions adopted by the united nations conference for the adoption of a convention on psychotropic substances, available at http://www.unodc.org/pdf/convention_1971_en.pdf. 28 see, e.g., wayne hall, feeling ‘better than well’, 5 embo rep. 1105-1109 (2004). http://dx.doi.org/10.1002/brb3.78 http://dx.doi.org/10.1038/sj.embor.7400303 738 indiana health law review vol. 12:2 neurocognitive enhancement. 29 people believe that intelligence is innate and immutable;30 consequently, if they evaluate their own performances as suboptimal they use stimulants in the service of changing their destinies. of those who consider that the brain is changeable, many people believe that the brain is a muscle, and that thinking builds brain cells so, the mythical analogy goes, thinking “more” or “faster” must somehow be good for the brain like aerobic exercise is good for the body. then, there is the popular culture belief that the brain is full of unused circuits and that our minds are limitless if we can but access the usually inaccessible areas.31 in addition to the neuromyths mentioned above that are conducive to efficacy beliefs, other neuromyths cause people to minimize risk. some neuromyths, for example, posit that the brain is modular, like a computer, leading people to believe that it is possible to affect one aspect of brain function without affecting others. add to this intuitive appeal the increasing reports in the media that stimulant medications are safe32 and effective in enhancing complex problem solving and overall cognition,33 the increase in demand and use is not surprising. a task for the provider is to identify and correct these misperceptions 29 see generally tracy d. gunter, can we trust consumers with their brains? popular cognitive neuroscience, brain images, self-help and the consumer, 11 ind. health l. rev. 483, 509-10 (2014). 30 male students believed taking performance-enhancing drugs for sports is more unethical than using stimulants to improve grades because of this belief that intelligence is innate. tonya dodge et al., judging cheaters: is substance abuse viewed similarly in the athletic and academic domain?, 26 psychol. addictive behav. 678, 680 (2012), available at www.apa.org/pubs/journals/releases/adb-ofp-dodge.pdf. 31 id.; lucy (europacorp 2014) (film concluding that using 100% of the brain’s capacity freed the protagonist from the continuum of space and time); limitless (relativity media 2011) (film about a writer using an experimental medication with the by line “accessing 100% of your brain is now possible with….”) 32 how do stimulants affect the brain and body, nat’l inst. on drug abuse, (nov. 2014), http://www.drugabuse.gov/publications/ research-reports/prescription-drugs/stimulants/how-do-stimulantsaffect-brain-body, archived at http://perma.cc/2cea-xuae. 33 desantis & hane, supra note 21. http://dx.doi.org/10.1037/a0027872 2015 cosmetic neurocognitive enhancement 739 in individuals requesting cosmetic neurocognitive enhancement. b. direct-to-consumer advertising as a driver of patient requests contributing to neuromyths in popular culture that would make cosmetic neurocognitive enhancement desirable and seemingly attainable, the products used are also familiar to people due to the increasing frequency with which stimulants have been prescribed in recent years. there is not doubt that dtca increases the number of requests for medications that patients bring to their providers and no doubt that the practice results in more prescriptions being written by providers. as the result of successful awareness campaigns and marketing, the use of prescription of stimulants increased exponentially and that increase is associated with increased non-medical use.34 amphetamines and other stimulant drugs have been used for more than 100 years for the treatment of impaired alertness, attention, and concentration. the products were first sold as otc elixirs, and later as prescription products. beginning twenty to thirty years ago, the regulatory environment became favorable for direct-to-consumer advertising (dtca) of prescription products by pharmaceutical companies that, prior to that time, directed most advertising to prescribing providers. in 1999 the pharmaceutical industry launched the first dtca campaign for stimulant drugs to treat children and other stimulant manufacturers followed suit in the two years that followed. the advertisements were typically lifestyle-based advertisements portraying ideal family life with the inference that such was possible if the parent treated the child’s behavioral problems with prescribed substance. soon thereafter the market became increasingly competitive with more companies and claims entering the market place. 34 s.e. mccabe et al., trends in medical use, diversion, and nonmedical use of prescription medications among college students from 2003 to 2013: connecting the dots, 39 addictive behaviors 1176 (2014). http://dx.doi.org/10.1016/j.addbeh.2014.03.008 740 indiana health law review vol. 12:2 in addition to raising awareness of treatable conditions, advertisements sometimes blur the boundaries between symptoms of normal function and those indicative of illness or disease, by emphasizing convenience, minimizing risk, overstating efficacy, and broadening indications, despite significant regulatory prohibitions.35 it was not until 2006 that the fda ordered a black box warning placed on stimulants for cardiovascular risk. this act quelled the dtca of stimulants to some extent. by this time, however, the influence of the advertising in the marketplace had already been felt. importantly, the food and drug administration (fda) cannot require drug companies to submit advertisements for approval prior to marketing. as a result, members of the public may see advertisements that violate regulatory standards for variable periods of time prior to fda review. during this interval, the individual viewing the advertisement will have no assistance in deducing whether the advertisement includes false or misleading information. 36 once a deceptive advertisement is discovered, the fda is empowered to send a letter to the manufacturer requesting that the company remove the advertisement or publish a corrective advertisement. in more egregious cases, the fda has the discretion to issue warning letters, seek an injunction, or bring criminal action against a pharmaceutical company. these actions, however, take time and there is also no particular requirement that the retraction or correction be displayed as prominently as the misleading advertisement. by the time the fda acts, much harm has potentially been done. 35 u.s. dep’t. of health & human servs. guidance for industry internet/social media platforms with character space limitations − presenting risk and benefit information for prescription drugs and medical devices, (june 2014), available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinfor mation/guidances/ucm401087.pdf. 36 see generally prescription drug advertising: questions and answers, u.s. food & drug admin. http://www.fda.gov/drugs/ resourcesforyou/consumers/prescriptiondrugadvertising /ucm076768 (last updated sept. 13, 2012) (answering common questions from consumers regarding direct-to-consumer advertising). 2015 cosmetic neurocognitive enhancement 741 as noted by singh, “the journey of stimulant drug advertising into the public domain has taken the claims of the drug maker from [symptomatic] control, to a blurring of control to normalization, to a clear vision of enhancement.”37 now that vision is a reality and the de facto gatekeeper has become the provider. c. so what is it that people do (and do not) want to alter? in the realm of cosmetic neurocognitive enhancement, people frequently cite goals of performing tasks better, working harder and optimizing personal achievement. though people seeking stimulant medications believe that enhancing attention, concentration and task persistence will lead inevitably to these goals, this is not necessarily the case. 38 some users believe that they suffer from undiagnosed adhd and seek stimulants as the appropriate treatment for their self-diagnosed disorder outside a formal medical evaluation. 39 others believe that because the primary motivation to use stimulants on a cosmetic basis is noble (i.e. to excel and assist others in excelling in the case of distribution) the use is more appropriate than in circumstances in which the primary motivation is to become intoxicated or euphoric.40 individuals requesting cosmetic neurocognitive enhancement generally emphasize autonomy and choice in making decisions about cosmetic neurocognitive enhancement, uniformly rejecting notions of compulsory use. 41 users prefer easily accessible otc drugs to 37 see ilina singh, not just naughty: 50 years of stimulant drug advertising, in medicating modern america: prescription drugs in history 131 (andrea tone & elizabeth siegel watkins eds, 2007). 38 richard j. haier, increased intelligence is a myth (so far), frontiers syss. neuroscience (mar. 12, 2014), http://journal.frontiersin.org/journal/10.3389/fnsys.2014.00034/full, archived at http://perma.cc/ay24-y854. 39 desantis & hane, supra note 21. 40 id. 41 sebastian sattler et al., impact of contextual factors and substance characteristics on perspectives toward cognitive http://dx.doi.org/10.3389/fnsys.2014.00034 742 indiana health law review vol. 12:2 prescription drugs. seekers of cosmetic neurocognitive enhancement favor medications of low risk and low cost, tolerating relatively few uncomfortable side effects and no serious side effects. 42 yet, many users of neurocognitive enhancers underestimate the risks involved in pharmaceuticals because they come through the medical establishment.43 individuals pursuing neurocognitive enhancement are generally not interested in altering traits they view as identifying or core personality characteristics such as mood and self-control as either direct effects or side effects of neurocognitive enhancement. 44 the reality, however, of brain manipulation is that changing one aspect of experience will doubtless change other aspects because the brain has a relatively small number of pathways that are used in different ways at different times for different things. the enterprise of cosmetic neurocognitive enhancement is all about trade offs, and owing to the biological reality of the connectome, will likely remain so for the foreseeable future. 45 for some users the trade off may be more enhancement, 8 plos one e71452 (2013). 42 id.; see also kimberly j. schelle et al., attitudes toward pharmacological cognitive enhancement—a review, 8 frontiers in systems neuroscience (2014). 43 see, e.g., alan schwartz, drowned in a stream of prescriptions, n.y. times, feb. 3, 2013, at a1. 44 laura y. cabrera et al., reasons for comfort and discomfort with pharmacological enhancement of cognitive, affective, and social domains, neuroethics (2014); schelle et al., supra note 43; cynthia forlini & eric racine, added stakeholders, added value(s) to the cognitive enhancement debate: are academic discourse and professional policies sidestepping values of stakeholders? 3 ajob primary res. 33 (2012) [hereinafter forlini, added stakeholders]; philip brey, human enhancement and personal identity, in new waves in philosophy of technology 169 (jan kyrre berg olsen friis et al. eds., 2009). 45 thomas hills & ralph hertwig, why aren’t we smarter already: evolutionary trade-offs and cognitive enhancements, 20 current directions psychol. sci. 373 (2011). http://dx.doi.org/10.1371/journal.pone.0071452 http://dx.doi.org/10.3389/fnsys.2014.00053 http://dx.doi.org/10.1007/s12152-014-9222-3 http://dx.doi.org/10.1080/21507716.2011.645116 http://dx.doi.org/10.1177/0963721411418300 2015 cosmetic neurocognitive enhancement 743 favorable than for others, but users must understand there will be a trade off.46 attempts to distinguish cosmetic neurocognitive enhancement from substance misuse or addiction have largely demonstrated more similarities among, than differences between, stimulant users identifying academic goals and those espousing recreational goals for their use.47 from a personality perspective, users of stimulants for cosmetic neurocognitive enhancement were more impulsive, less prosocial, less empathic, and more strategic and instrumental in their approach to life circumstances compared to individuals that did not use stimulants. 48 those using cosmetic neurocognitive enhancement were more likely to associate stimulant use with recreation, report exaggerated well being, 49 abuse other substances (e.g. alcohol, marijuana, cocaine, ecstasy), and engage in risky activities. 50 users of cosmetic neurocognitive enhancement failed to achieve objective long-term academic benefit despite report of short-term gains in self-perceived 46 hannah maslen et al., pharmacological cognitive enhancement— how neuroscientific research could advance ethical debate, 8 frontiers sys. neuroscience 107 (2014). 47 see eric racine & cynthia forlini, cognitive enhancement, lifestyle choice or misuse of prescription drugs?, 3 neuroethics 1 (2008) (providing a review of this topic) [hereinafter racine, cognitive enhancement]; amelia m. arria & robert l. dupont, nonmedical prescription stimulant use among college students: why we need to do something and what we need to do, 29 journal of addictive diseases 417 (2010); matthias vonmoos et al., differences in selfreported and behavioral measures of impulsivity in recreational and dependent cocaine users 133 drug alcohol dependence 61 (2013); marissa j. maier, pharmacological cognitive enhancement in healthy individuals: a compensation for cognitive deficits or a question of personality? 10 plos one e0129805 (2015). 48 maier, supra note 48. 49 cynthia m. hartung et al., stimulant medication use in college students: comparison of appropriate users, misusers, and nonusers, 27 psychol. addictive behavs. 832 (2013). 50 shaheen e. lakhan & annette kirchgessner, prescription stimulants in individuals with and without attention deficit hyperactivity disorder: misuse, cognitive impact, and adverse effects, 2 brain & behav. 661 (2012); hartung et al., supra note 50. http://dx.doi.org/10.3389/fnsys.2014.00107 http://dx.doi.org/10.1007/s12152-008-9023-7 http://dx.doi.org/10.1080/10550887.2010.509273 http://dx.doi.org/10.1016/j.drugalcdep.2013.05.032 http://dx.doi.org/10.1371/journal.pone.0129805 http://dx.doi.org/10.1037/a0033822 http://dx.doi.org/10.1002/brb3.78 744 indiana health law review vol. 12:2 cognitive ability,51 regardless of whether the individual is identified as healthy or as an individual affected by adhd. 52 it may well be that stimulants exert their primary enhancement effects on the emotions of users, as opposed to the cognition of users.53 the moniker of “smart drug” may in fact conceal the degree to which the alteration sought is a mood alteration clothed in the language of intellect and achievement. purposeful deception of physicians to obtain prescription stimulants may be more common than generally believed,54 but continues to represent a minority of interactions with providers.55 users of stimulants for cosmetic neurocognitive enhancement are more likely to have antisocial features, which may increase the risk for purposeful deception of others. 56 particularly among young adults, males, and individuals at the low and high extremes of income were more likely to report attempts to deceive physicians, as were young people who reported abusing recreational substances and those identified as lesbian-gay-bisexualtransgendered.57 several commentators have observed that prescribers are particularly easy to deceive,58 and symptoms of disorders for which stimulants are prescribed are easy to feign. 59 the tactics identified by individuals deceiving 51 hartung et al., supra note 50. 52 claire advokat & mindy scheithauer, attention-deficit hyperactivity disorder (adhd) stimulant medications as cognitive enhancers, frontiers neuroscience (may 29, 2013), http://journal.frontiersin.org/article/10.3389/fnins.2013.00082/full. 53 scott vrecko, just how cognitive is “cognitive enhancement”? on the significance of emotions in university students’ experiences with study drugs, 4 ajob neuroscience 4 (2013) [hereinafter vrecko, just how cognitive]. 54 john m. stogner et al., deception for drugs: self-reported “doctor shopping” among young adults, 27 j. am. board fam. med. 583 (2014). 55 id. 56 maier, supra note 48. 57 stogner et al., supra note 55. 58 schwartz, supra note 44; trent wolbe, how i hacked my brain with adderall: a cautionary tale, the verge (july 26, 2012, 10:38 am), http://www.theverge.com/2012/7/26/3184496/hacked-brainadderall-cautionary-tale, archived at http://perma.cc/aj6x-n2aa. 59 will oresmus, the new stimulus package, slate (2013) http://dx.doi.org/10.3389/fnins.2013.00082 http://dx.doi.org/10.1080/21507740.2012.740141 http://dx.doi.org/10.3122/jabfm.2014.05.140107 2015 cosmetic neurocognitive enhancement 745 clinicians include memorizing symptoms of adhd and responding in deceptive ways on adhd screening questions, writing things on their hands or displaying other signs of disorganization characteristic of adhd, and complaining of improving but persistent symptoms to accomplish dose escalation that would lead to a sufficient supply of stimulant for the index “patient” and those to whom he or she may divert it.60 iv. responses: provider issues providers have varying levels of comfort with patient requests for enhancement and respond to these requests in a variety ways. many providers grant requests for enhancement and offer patients enhancements, though there is a significant minority that rejects enhancement of any kind as outside the practice of medicine.61 in addition to concerns about legitimacy of enhancement in health care and the goals of the doctor-patient relationship, safety, social factors, and patient-specific factors contributed to provider ambivalence.62 http://www.slate.com/articles/technology/superman/2013/03/adderall_rit alin_vyvanse_do_smart_pills_work_if_you_don_t_have_adhd.html; randy a. sansone & lori a. sansone, faking attention deficit hyperactivity disorder, 8 innovations in clinical neuroscience 10 (2011). 60 scott vrecko, everyday drug diversions: a qualitative study of the illicit exchange and non-medical use of prescription stimulants on a university campus, 131 soc. sci. & med. 297 (2015) [hereinafter vrecko, everyday drug diversions]. 61 timothy d. hotze et al., response to open peer commentaries on “‘doctor, would you prescribe a pill to help me…?’ a national survey of physicians on using medicine for enhancement,” 11 am. j. bioethics w1 (2011) [hereinafter hotze et al., response]. 62 cynthia forlini & eric racine, considering the causes and implications of ambivalence in using medicine for enhancement, 11 am. j. bioethics 15 (2011) [hereinafter forlini, considering the causes]. http://dx.doi.org/10.1016/j.socscimed.2014.10.016 http://dx.doi.org/10.1080/15265161.2011.548195 746 indiana health law review vol. 12:2 a. models of provider-patient interactions how the provider understands the patient relationship is a significant variable in the response to patient requests. the traditional biomedical model is one in which providers rely on paternalism and objective data to guide their interactions with ill patients. in this model, the responsibilities for diagnosis, treatment selection, treatment monitoring, and treatment goals all reside with the beneficent professional acting in his patient’s best interest. the patient, in this model, offers his symptoms to the provider and accepts the treatment prescribed. the assumption in the biomedical model is that the patient and provider share amelioration of illness as the goal and both provider and patient will place high value on the symptomfree state. the biomedical model frequently works well with older, ill, distressed, and less-educated patients,63 pursuing traditional treatments and treatment goals for a mutually identified disease state. traditional biomedical providers typically derive authority from the greater biomedical knowledge they possess and place a high level of confidence in evidencebased practices. evidence-based medicine emphasizes the published literature as the primary source of credible information and authority.64 technical information offered to patients by biomedical providers will be informed by a combination of evidence from the professional literature, professional experience, and personal values. cosmetic neurocognitive enhancement will succeed in the biomedical model typically used by traditional providers only when evidence from groups of similarly situated subjects demonstrates that there is known and discernible benefit that outweighs known risk.65 63 sara l. swenson et al., patient-centered communication: do patients really prefer it? 19 j. gen. internal med. 1069 (2004). 64 see, e.g., laurence greenhill et al., practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults, 41 j. am. acad. child & adolescent psychiatry 26s (2 supp. 2002). 65 hotze et al., doctor, supra note 15. dx.doi.org/10.1111/j.1525-1497.2004.30384.x http://dx.doi.org/10.1097/00004583-200202001-00003 2015 cosmetic neurocognitive enhancement 747 by contrast, most patients who seek cosmetic neurocognitive enhancement will be demographically different from those who prefer a traditional biomedical approach. younger, healthier, and more highly educated patients will tend to prefer provider interactions that fall on the spectrum of informed choice 66 and shared decisionmaking models.67 although perspectives from traditional biomedical, informed choice and shared decision-making models are not mutually exclusive, they do have different centers of control, rely on different sources of authority, and prioritize different outcomes.68 in traditional biomedical models, the provider makes the diagnosis, decides on treatment, and gives the patient information on the treatment and its risks, with some acknowledgment of alternatives. in informed choice models, the provider still sets the goals of treatment, but offers information without a specific recommendation to a more active patient considering treatments. in shared decisionmaking models, the provider offers information specific to the patient’s stated goals and objectives with as little bias as possible and without any particular recommendation. in informed choice and shared decision-making models, the provider’s goal is to understand the patient’s experience, wishes, and needs for the encounter from a broader biopsychosocial perspective, consistent with the definition of health care put forward by the who. the provider focuses on the patient’s subjective need as the indication for the intervention, without relying on the presence of an illness as the threshold for providing a treatment intervention. the provider using a patient-centered frame of reference will likely be more comfortable with using the patient’s opinion of the intervention as a viable justification for the intervention and for the evaluation of the effectiveness of 66 elizabeth murray et al., clinical decision-making: patients’ preferences and experiences, 65 patient educ. & counseling 189 (2007). 67 bernard lo, resolving ethical dilemmas: a guide for clinicians 177-180 (5th ed. 2013). 68 jozien bensing, bridging the gap. the separate worlds of evidence-based medicine and patient-centered medicine, 39 patient educ. & counseling 17 (2000). http://dx.doi.org/10.1016/j.pec.2006.07.007 http://dx.doi.org/10.1016/s0738-3991(99)00087-7 748 indiana health law review vol. 12:2 the intervention. providers operating in this frame may, for instance, go beyond responding to patient requests for cosmetic enhancement to offering the patient a cosmetic enhancement on a regular basis.69 in most studies, patient satisfaction was associated with the more patient-centered approaches to the providerpatient relationship, specifically with provider attention to patient concerns and specific information about patient concerns from the provider. 70 although outcomes among satisfied patients are difficult to assess,71 compliance with provider recommendations appears highest among satisfied patients.72 discord between providerand patient-centric models appears greatest when the provider does not value the patient’s goal, believe that the available evidence supports the patient’s expected benefit, or agree with the patient’s assessment of risk.73 for providers choosing to offer cosmetic neurocognitive enhancement to their patients, a shared decision-making model is most likely to be constructive in both assessing areas of functional change and in maximizing the compliance necessary to minimize individual and societal risks associated cosmetic neurocognitive enhancement. 69 hotze et al., response, supra note 62. 70 linda c. zandbelt et al., satisfaction with the outpatient encounter: a comparison of patients’ and physicians’ views, 19 j. gen. internal med. 1088 (2004). 71 joshua j. fenton, the cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality, 172 archives internal med. 405 (2012); linda brookes, patient satisfaction and quality of care: are they linked?, medscape family med. (2014). 72 kelly b. haskard zolnierek & m. robin dimatteo, physician communication and patient adherence to treatment: a meta-analysis, 47 med. care 826 (2009). 73 tammy c. hoffmann & chris del mar, patients’ expectations of the benefits and harms of treatments, screening, and tests: a systematic review, 175 jama internal med. 274 (2015). http://dx.doi.org/10.1111/j.1525-1497.2004.30420.x http://dx.doi.org/10.1001/archinternmed.2011.1662 http://dx.doi.org/10.1097/mlr.0b013e31819a5acc http://dx.doi.org/10.1001/jamainternmed.2014.6016 2015 cosmetic neurocognitive enhancement 749 b. provider attitudes about enhancement regardless of orientation of the provider to the providerpatient relationship, providers are generally risk-adverse.74 the combination of unclear benefit and significant safety concerns contribute to discomfort in prescribing cosmetic neurocognitive enhancement. 75 providers distrust safety claims about stimulants with good reason. pemoline, for example, was a stimulant medication on the market for twenty-five years before concerns about liver injury became apparent and a black box warning was added to the labeling. it was then removed from the market five years later. 76 as a second example, the health risks of fenfluramine came to light after twenty-five years of market presence, when combined with phentermine (a stimulant) that had been on the market for almost forty years. use of the combination product fen-phen for rapid weight loss has resulted in billions of dollars in litigation costs, medical surveillance, and damage awards.77 after experiences such as these, providers will generally favor identifying an existing target symptom or sign of disability to merit the risk of prescribing stimulant medications. 74 opeyemi c. banjo et al., physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount, plos one (dec. 14, 2010), http://journals.plos.org/ plosone/article?id=10.1371/journal.pone.0014322. 75 forlini, considering the causes, supra note 63. 76 information for healthcare professionals: pemoline tablets and chewable tablets (marketed as cylert), food & drug admin. (oct. 2005), http://www.fda.gov/drugs/drugsafety/postmarketdrugsafety informationforpatientsandproviders/ucm126461.htm, archived at http://perma.cc/r662-66zc. 77 see e. colman, anorectics on trial: a half century of federal regulation of prescription appetite suppressants, 143 ann. intern. med. 380 (2005); $3.75 billion fen-phen settlement now final, associated press, jan. 11, 2002; jef feeley, pfizer asks end to fenphen suits linked to lung ailment, bloomberg news (aug. 23, 2012); food and drug admin., fda announces withdrawal fenfluramine and dexfenfluramine (fen-phen) (1997); food and drug admin., questions and answers about withdrawal of fenfluramine (pondimine) and dexfenfluramine (redux) (2005). http://dx.doi.org/10.1371/journal.pone.0014322 http://dx.doi.org/10.7326/0003-4819-143-5-200509060-00013 750 indiana health law review vol. 12:2 in addition to ambivalence about safety and risk, providers are also ambivalent about access to cosmetic neurocognitive enhancement. most providers believe that enhancement should be equally available to all people, 78 yet providers do not believe that third-party payers should cover enhancements.79 they tend to view younger patients as not needing stimulant drugs and having sufficient nonpharmacological options for obtaining the same goals. 80 providers were most comfortable prescribing to older patients to improve overall health, daily living, and support personal efficacy,81 a finding that is concerning given the rate of misuse among people of advanced age 82 and the potential for drug interactions in those older adults receiving multiple medications. when asked directly about enhancement, providers believed that enhancements could help people be happier, and identified subjective suffering, social pressures, and occupational problems as important factors. higher provider comfort with prescribing enhancement has been 78 see, e.g., cynthia forlini & eric racine, autonomy and coercion in academic “cognitive enhancement” using methylphenidate: perspectives of key stakeholders, 2 neuroethics 163 (2009) [hereinafter forlini, autonomy and coercion]. 79 hotze et al., doctor, supra note 15. 80 banjo et al., supra note 75. 81 id. 82 see j.w. culberson et al., prescription medication use among self neglecting elderly, 22 j. addictions nursing, 63 (2011); comm. on the mental health workforce for geriatric populations, the mental health and substance use workforce for older adults: in whose hands? (jill eden et al., eds., national academies press 2012); raj k. kalapatapu & maria a. sullivan, prescription use disorders in older adults, 19 am. j. addictions 515 (2010); jane carlisle maxwell, the prescription drug epidemic in the united states: a perfect storm, 30 drug & alcohol rev. 264 (2011); laxmaiah manchikanti, prescription drug abuse: what is being done to address this new drug epidemic? testimony before the subcommittee on criminal justice, drug policy and human resources, 9 pain physician 287 (2006); x. laqueille et al., methylphenidate effective in treating amphetamine abusers with no other psychiatric disorder, 20 eur. psychiatry 456 (2005); linda simoni-wastila & huiwen keri yank, psychoactive drug abuse in older adults, 4 am. j. geriatric pharmacotherapy 380 (2006). http://dx.doi.org/10.1007/s12152-009-9043-y http://dx.doi.org/10.3109/10884602.2010.545089 http://dx.doi.org/10.1111/j.1521-0391.2010.00080.x http://dx.doi.org/10.1111/j.1465-3362.2011.00291.x http://dx.doi.org/10.1016/j.eurpsy.2005.03.013 http://dx.doi.org/10.1016/j.amjopharm.2006.10.002 2015 cosmetic neurocognitive enhancement 751 associated with older provider age, male gender, minority race, and high frequencies of patient requests for enhancement.83 recalling that dtca tends to lead to more requests for medications, and applying now the notion that providers who hear more requests tend to be receptive to granting those requests, the impact of stimulant marketing is felt by both providers as well as patients. additionally, some providers will have personal experience with cosmetic neurocognitive enhancement that will likely inform their recommendations to patients. one in five medical students use cosmetic neurocognitive enhancement, 84 and most plan to continue use after graduation.85 the predicted continuation is bourn out by studies of practitioners demonstrating that a similar percentage report using stimulants solely for cognitive enhancement on at least one occasion, usually in association with environmental pressures. 86 these personal experiences may facilitate comfort with the practice of cosmetic neurocognitive enhancement. c. availability of enhancing drugs (off-label prescribing) there are no specific legal or regulatory barriers to the use of prescription drugs for cosmetic neurocognitive enhancement. although the pharmaceutical industry may only promote and advertise drugs for approved uses, 87 83 see haier, supra note 39; stogner, supra note 55. 84 see jadon webb et al., prevalence of stimulant use in a sample of us medical students, 25 annals of clinical psychiatry 27 (2013); paul a. kudlow et al., cognitive enhancement in canadian medical students, 45 j. psychoactive drugs 360 (2013); robyn m. emanuel et al., cognitive enhancement drug use among future physicians: findings from a multi-institutional census of medical students, 28 j. gen. internal med. 1028 (2013). 85 see john b. bossaer et al., the use and misuse of prescription stimulants as "cognitive enhancers" by students at one academic health sciences center, 88 acad. med. 967 (2013). 86 andreas g. franke et al., use of illicit and prescription drugs for cognitive or mood enhancement among surgeons, 11 bmc med. 102 (2013). 87 i.e., approved uses are recognized by the fda as the only legitimate intended uses for the purposes of promotion and labeling. http://dx.doi.org/10.1080/02791072.2013.825033 http://dx.doi.org/10.1007/s11606-012-2249-4 http://dx.doi.org/10.1097/acm.0b013e318294fc7b http://dx.doi.org/10.1186/1741-7015-11-102 752 indiana health law review vol. 12:2 licensed providers are not constrained from using medications for conditions other than those outlined in the fda approved uses. 88 off-label prescribing is common 89 and very much in the mainstream of medical practice. 90 there are, however, some responsibilities incumbent on the provider who undertakes this practice. the provider must base the off-label drug use on sound medical judgment and firm scientific rationale. 91 the provider must also thoroughly document the intervention, and obtain adequate informed consent. even with these necessary steps, liability for off-label prescribing is a provider risk worthy of consideration and management through thorough documentation and peer consultation. proponents of off-label prescribing typically also favor allowing pharmaceutical companies to detail providers on off-label uses. when looking at established interventions and their indications, the professional literature is adequate to inform the provider. however, when either the drug or the indication is novel, the peer-reviewed literature will be lacking. presumably the pharmaceutical company that developed a new agent will have the most data about new products and could make high-quality information from preclinical trials available to providers contemplating offlabel use. this would then allow the provider could discharge his above-mentioned responsibility to have thoroughly researched the agent prior to prescribing it. implicit in this point of view is a high level of confidence in the ability of the provider to differentiate factual 88 judith edersheim, off-label prescribing, psychiatric times (apr. 14, 2009), http://www.psychiatrictimes.com/articles/labelprescribing, archived at http://perma.cc/ye4k-wdvw. 89 id. 90 stephen m. stahl, prescribing off-label in psychopharmacology: is it the exception or the rule?, 1 psyched up 5 (2005). 91 “off-label” and investigational use of marketed drugs, biologics, and medical devices, u.s. food & drug admin., www.fda.gov/regulatoryinformation/guidances/ucm126486.htm, archived at http://perma.cc/98zw-5rga (last updated june 25, 2014); off-label use and the medical standard of care, drug and device law, (nov. 2, 2012) http://druganddevicelaw.blogspot.com/2012/11/offlabel-use-and-medical-standard-of.html archived at http://perma.cc/49j8-rhch. 2015 cosmetic neurocognitive enhancement 753 information from persuasive marketing and this confidence is frequently unmerited.92 one possible way to create new sources of information on which providers could rely would be the establishment of efficacy and side-effect reporting schemes for off-label drug uses. this would provide a way for providers using cosmetic neurocognitive enhancement to communicate with one another and standardize some level of peer consultation. it is a potential way to create a source of information to which providers could turn to learn about novel agents, novel uses of established agents, and side effects from prescribed doses. while there are risks such as bias and incorrect inference inherent in this kind of informal research, access to data beyond the provider’s individual professional experience could combat arguments that off-label prescribing is uniformly uninformed and wasteful.93 d. currently available enhancing drugs 1. schedule ii drugs the most commonly used (and abused) drugs for neurocognitive enhancement are the schedule ii prescription amphetamines and methylphenidate. generic names include methylphenidate, desmethylphenidate, detroamphetamine, and lisdexamphetamine. trade names of some of these drugs include adderall, dexedrine, ritalin, concerta, vyvanse, and focalin. street names include skittles, smarties, crosses, speed, and uppers. sometimes 92 a supposition that is not true. not only are providers influenced by ads, they frequently underestimate the degree to which they are influenced. this literature is reviewed elsewhere. 93 philip m. rosoff & doriane lambelet coleman, the case for legal regulation of physicians’ off-label prescribing, 86 notre dame l. rev. 649, 655 (2011); madeline j. cohen, off-label: combating the dangerous overprescription of amphetamines to children, 82 geo. wash. l. rev. 174 (2013); evelyn pringle, it’s time to sue doctors who prescribe drugs off-label part i, lawyers and settlements (aug. 15, 2007, 12:45 pm), http://www.lawyersandsettlements.com/articles/drugsmedical/off-label-drugs-01288.html archived at http://perma.cc/6thfk4am. 754 indiana health law review vol. 12:2 these medications are erroneously described as universally effective for adult adhd and universally enhancing. in fact, the evidence is decidedly more mixed.94 amphetamines and methylphenidate work by prolonging the action of dopamine and norepinephrine, resulting in activation of nerve cells in reward and executive function pathways, with a net result of improving focus, wakefulness, and concentration. short-term effects of relatively low oral doses include increased energy, alertness, and goal-directed activity, but sometimes come with the cost of increased anxiety and dysphoria with decreased multi-task coordination, cognitive flexibility, selfmonitoring,95 and neural plasticity.96 other side effects associated with stimulant use include an unrealistic optimism, inflated sense of well-being, and inflated sense of ability. 97 those taking non-medical stimulants perceive themselves as performing significantly better than their peers, despite the objective indicators to the contrary.98 as dose increases, affirmative risk taking coupled with decreased risk avoidance appears more prominent. for example, drivers under the influence of 94 see, e.g., samuel kuperman et al., bupropion sr vs. methylphenidate vs. placebo for attention deficit hyperactivity disorder in adults, 13 ann. of clinical psychiatry 129 (2001); katherine sharpe, medication: the smart-pill oversell, 506 nature (2014), available at http://www.nature.com/news/medication-the-smartpill-oversell-1.14701; katherine sharpe, medication: the smart-pill oversell, 506 nature (2014), available at http://www.nature.com/news/medication-the-smart-pill-oversell-1.14701 (evidence is mounting that medication for adhd doesn't make a lasting difference to schoolwork or achievement). 95 anna-katherine brem et al., is neuroenhancement by noninvasive brain stimulation a net zero-sum proposition?, 85 neuroimage 1058 (2013). 96 kimberly r. urban & wen-jun gao, performance enhancement at the cost of potential brain plasticity: neural ramifications of nootropic drugs in the healthy developing brain, 8 frontiers in sys. neuroscience 1(2014). 97 irena p. ilieva & martha j. farah, enhancement stimulants: perceived motivational and cognitive advantages, 7 frontiers in neuroscience (2013), available at http://journal.frontiersin.org/journal/10.3389/fnins.2013.00198/full. 98 bossaer, supra note 86. http://dx.doi.org/10.3109/10401230109148958 http://dx.doi.org/10.1038/506146a http://dx.doi.org/10.1016/j.neuroimage.2013.07.038 http://dx.doi.org/10.3389/fnsys.2014.00038 http://dx.doi.org/10.3389/fnins.2013.00198 2015 cosmetic neurocognitive enhancement 755 stimulants engaged in more speeding, were more impatient, exhibited diminished divided attention, and failed to stop appropriately.99 though these stimulants have complex effects on internal experience and motivation, there is no objective evidence to suggest that critical judgment, wisdom, generalized intelligence, competence, or overall achievement improve when taking stimulants 100 notwithstanding folk psychology and media portrayals.101 there is little evidence to suggest that stimulants exert the same effects in individuals of high intelligence and normal cognitive ability than they do in cognitively impaired populations.102 in a meta-analysis of studies of methylphenidate, the data “provide no consistent evidence for neuroenhancement effects.”103 turning from efficacy to safety, data suggest that users of cosmetic neurocognitive enhancement reported side of effects during non-medical use of stimulants including anorexia (68.2% of non-medical users), insomnia (54.5%), tachycardia (34.1%), anxiety (15.9%), tremor (15.9%), 99 h. schulze et al., driving under the influence of drugs, alcohol and medicines in europe—findings from druid project, european monitoring centre for drugs and drug addiction (emcdda) (2012), www.emcdda.europa.eu/attachements.cfm/att_192773_en_ tdxa12006enn.pdf; c. stough et al., the effects of mdma and methamphetamine on car driving simulator performance, cognitive skills, and mood states, 4 open addiction journal 57 (2011). 100 see fiorlini racine, disagreements with implications: diverging discourses on the ethics of non-medical use of methylphenidate for performance enhancement, 10 bmc medical ethics (2009), available at http://www.biomedcentral.com/1472-6939/10/9. 101 wolbe, supra note 59; will oremus, the new stimulus package: overachievers are popping adderall to get ahead. is that a good idea?, slate, march 27, 2013, http://www.slate.com/articles/technology/ superman/2013/03/adderall_ritalin_vyvanse_do_smart_pills_work_if_yo u_don_t_have_adhd.html, archived at http://perma.cc/at6u-ndvm. 102 shaheen e. lakhan & annette kirchgessner, prescription stimulants in individuals with and without attention deficit hyperactivity disorder: misuse, cognitive impact, and adverse effects, 2 brain behavior 661, 661-667 (2012); maslen, supra note 47. 103 dimitris repantisa et al., modafinil and methylphenidate for neuroenhancement in healthy individuals: a systematic review, 62 pharmacological research 187-206 (2010). http://dx.doi.org/10.1186/1472-6939-10-9 http://dx.doi.org/10.2174/1874941001104010057 http://dx.doi.org/10.1002/brb3.78 http://dx.doi.org/10.1016/j.phrs.2010.04.002 756 indiana health law review vol. 12:2 headache (13.6%), and a sense of dependence on the stimulant for concentration (9.1%).104 in addition to these somewhat obvious side effects, non-obvious physical risks such as sudden death and painful sustained penile erection in boys and men have become more frequent as use of schedule ii amphetamine type stimulant medications has increased. 105 emergency department (ed) visits and mentions have gone up over time, with stimulant related visits rising by 196% between 2004 and 2010.106 of note, the greatest increase in ed mentions involves stimulants among adults.107 this likely parallels the dramatic rise in the prescription of these drugs to adults.108 2. schedule iv drugs the wakefulness agents modafinil (provigil) and armodafinil (nuvigil) have been used for cosmetic neurocognitive enhancement. modafinil has some abuse potential, but less than other prescription stimulants. 109 104 bossaer, supra note 86. 105 fda drug safety communication: fda warns of rare risk of long-lasting erections in males taking methylphenidate adhd medications and has approved label changes, fda (dec. 17, 2013), http://www.fda.gov/drugs/drugsafety/ucm375796.htm#, archived at http://perma.cc/a8rv-eu92. 106 drug abuse warning network, highlights of the 2010 drug abuse warning network (dawn) findings on drug-related emergency department visits, the dawn report, http://www.samhsa.gov/data/2k12/dawn096/sr096edhighlights2010. htm, archived at http://perma.cc/xtr7-8s8l. 107 id. 108 mark olfson et al., trends in office-based treatment of adults with stimulants in the united states, 74 j. clinical psychiatry 43 (2013). 109 see fda warning ltr. re: nda #20-717 provigil (modafinil) tablets from james r. rogers (jan. 14, 2002), www.modafinil.com/fda/, archived at http://perma.cc/9vry-geue; stefan p. kruszewski, euphorigenic and abusive properties of modafinil, letters to the editor, 163 am. j. psychiatry 549 (2006); fda, provigil (modafinil) tablets, detailed view: safety labeling changes approved by fda center for drug evaluation and research (cder), http://www.fda.gov/ safety/medwatch/safetyinformation/ucm233612.htm, archived at http://perma.cc/6222-9g9n. http://dx.doi.org/10.4088/jcp.12m07975 http://dx.doi.org/10.1176/appi.ajp.163.3.549 2015 cosmetic neurocognitive enhancement 757 although indicated only for sleep disorders and phase shift disorders, modafinil has received attention for increasing use for off-label indications. 110 not all studies have demonstrated an effect on cognition111 but faster reaction time, 112 improved working memory, more sustained attention,113 and improved cognitive flexibility were noted among modafinil subjects when compared to similarly sleepdeprived controls.114 effects of modafinil are also similar to amphetamines in non-sleep deprived individuals, particularly at higher doses.115 when compared to amphetamines and caffeine, modafinil exerts similar effects on wakefulness and vigilance, 116 but does not improve complex decisionmaking. 117 although individuals with prior drug abuse report feeling intoxicated, non-sleep deprived individuals without a history of substance abuse did not.118 in the most recent systematic review and meta-analysis of the available data on modafinil, researchers concluded that the literature supported the idea that modafinil improved attention in 110 renée a. peñaloza et al., trends in on-label and off-label modafinil use in a nationally representative sample, 173 jama intern med. 704-06 (2013). 111 delia c. randall et al., modafinil affects mood, but not cognitive function, in healthy young volunteers, 18 hum. psychopharmacology 163, 166-67 (2003). 112 joseph v. baranski et al., effects of modafinil on cognitive and meta-cognitive performance, 19 hum. psychopharmacology clinical & experimental 323, 323-32 (2004). 113 michelle gill et al., cognitive performance following modafinil versus placebo in sleep-deprived emergency physicians: a doubleblind randomized crossover study, 158 13 soc’y for acad. emergency med. 158, 158-65 (2006). 114 colin sugden et al., effect of pharmacological enhancement on the cognitive and clinical psychomotor performance of sleep-deprived doctors: a randomized controlled trial, 255 annals surgery 222, 222-27 (2012). 115 angela p. makris et al., behavioral and subjective effects of damphetamine and modafinil in healthy adults, 15 experimental & clinical psychopharmacology 123, 123-33 (2007). 116 william d. s. killgore et al., gambling when sleep deprived: don't bet on stimulants, 29 chronobiology int’l 43, 43-54 (2012). 117 id. at 43. 118 makris et al., supra note 116, at 131. http://dx.doi.org/10.1001/jamainternmed.2013.2807 http://dx.doi.org/10.1002/hup.456 http://dx.doi.org/10.1002/hup.596 http://dx.doi.org/10.1197/j.aem.2005.08.013 http://dx.doi.org/10.1097/sla.0b013e3182306c99 http://dx.doi.org/10.1037/1064-1297.15.2.123 http://dx.doi.org/10.3109/07420528.2011.635230 758 indiana health law review vol. 12:2 non-sleep deprived individuals but was not associated with improvements in other cognitive abilities such as task accuracy and timing.119 although modafinil is a popular study drug in europe, and has been tested as an alternative to d-amphetamine as a wakefulness-promoting agent,120 use in the united states may be limited by cost and availability. although its effects on neural plasticity are unknown,121 modafinil does have an advantage over schedule ii amphetamines and methylphenidate in abuse liability. modafinil is not dissolvable in water and does not remain stable at high temperature, so it cannot be injected or snorted. these features may make it a viable choice for providers engaging in conversations with patients about cosmetic neurocognitive enhancement. 3. otc drugs a number of otc drugs, nutritional supplements, and foods promising cosmetic neurocognitive enhancement are available to consumers on an increasing basis. the otc drug market is by far the largest drug distribution system in the united states and is steadily growing, providing at least limited access to health care for people who would not otherwise have it.122 in addition to traditional otcs, health care consumers reach for supplements and food products to address cognitive health concerns. herbal supplements have shown steady growth and sales reached 5.6 billion dollars in 2012. 123 the global healthy food market is 119 michael j. minzenberg & cameron s. carter, modafinil: a review of neurochemical actions and effects on cognition, 33 neuropsychopharmacology 1477, 1477-1502 (2008). 120 arthur estrada et al., modafinil as a replacement for dextroamphetamine for sustaining alertness in military helicopter pilots, 83 aviation, space & envtl. med. 556, 556-64 (2012). 121 urban & gao, supra note 97. 122 consumer healthcare products association, the value of otc medicine to the united states 3 (jan. 2012), http://www.chpa.org/valueofotcmeds2012.aspx. 123 hank schultz, herbal supplement sales rose 5.5% in us in 2012, abc says, nutra ingredients-usa (aug. 19, 2013), http://dx.doi.org/10.1038/sj.npp.1301534 http://dx.doi.org/10.3357/asem.3129.2012 2015 cosmetic neurocognitive enhancement 759 growing as well and is predicted to reach one trillion dollars in 2017.124 from magic pills and potions, to super foods, these items are advertised as short cuts to the achieving the benefits of exercise, balanced diet, and healthy lifestyle without putting forth the effort to engage in these activities. information offered about these products in the market place is frequently specious and overblown. apart from advertisements, frequently disguised as health information, people have little information about effectiveness and risk.125 supplements and smart foods are available without consultation with a health care provider and many providers are disinterested in patient use of these compounds because they sometimes erroneously believe the substances to be essentially inert compounds. when compared to modafinil, the herbal agents bacopa and ginseng produced similar effects on wakefulness and a variety of supplements have been associated with liver failure and other significant side effects.126 the makers of these products have successfully crafted language to avoid regulation, by emphasizing promotion of wellness versus claims of treating disease. although there have been calls to hold producers to a higher level of conduct when dealing directly with consumers, there is still little protection for the individual consumer. 127 additionally, advertisements for these products are http://www.nutraingredients-usa.com/markets/herbal-supplementsales-rose-5.5-in-us-in-2012-abc-says, archived at http://perma.cc/22h3-bkrm. 124 shane starling, global healthy foods to hit $1 trillion in 2017: report, nutra ingredients-usa (nov. 26, 2012), http://www.nutraingredients.com/consumer-trends/global-healthyfoods-to-hit-1-trillion-in-2017-report, archived at http://perma.cc/u7hlszwr. 125 for a review see gunter, supra note 29. 126 victor j. navarro et al., liver injury from herbals and dietary supplements in the u.s. drug-induced liver injury network, 60 hepatology 1399 (2014). 127 see generally denise e. delorme et al., the state of public research on over-the-counter drug advertising, 4 int’l j. pharmaceutical and healthcare marketing 208 (2010). http://dx.doi.org/10.1002/hep.27317 http://dx.doi.org/10.1108/17506121011076156 760 indiana health law review vol. 12:2 frequently antagonistic toward pharmaceutical manufacturers, health care providers, and health care systems thus alienating people from the very systems in place to inform and protect them. although abuse potential is recognized as a challenge for otc drugs just as for prescription drugs, 128 some nonamphetamine stimulant medications continue to be available without a prescription including caffeine, ephedrine, phenylpropanolamine, and pseudoephedrine. energy drinks and a variety of supplements may combine one or more of these compounds in the same product to improve wakefulness and energy. these combination agents appear to have both effects (i.e. improved vigilance and wakefulness without a concomitant increase problem solving skills or improving complex decision-making) and risks similar to prescribed stimulants.129 when taken as a whole, the literature on amphetamines, methylphenidate, modafinil, and otc stimulants suggest that measurable improvements in cognition are modest, and generally related to increased wakefulness and arousal. subjective improvements are greater and related to feeling energized, having more motivation, and enjoying tasks more, 130 though these seem to come at the cost of overestimating actual performance on the task in question. importantly for prescribers of stimulants, non-medical stimulant users tend to use many substances 128 “more than one in ten teens (12%) report lifetime use of over-thecounter cough or cold medicines to get high.” prescription for disaster: how teens abuse medicine, dea (2d ed. 2012), available at http://www.justice.gov/dea/pr/multimedialibrary/publications/prescription_for_disaster_english.pdf, archived at http://perma.cc/ac2z-7ll3. otc stimulants comprise over half of the otcs that are abused by teens. michael r. cohen, 10 over-the-counter medicines abused by teens, philly.com (jan. 14, 2013), http://www.philly.com/philly/blogs/healthcare/10-over-the-countermedicines-abused-by-teens.html, archived at http://perma.cc/y55pht9t. 129 fabian sanchis-gomar et al., energy drink overconsumption in adolescents: implications for arrhythmias and other cardiovascular events, 31 canadian j. cardiology 572 (2015). 130 vrecko, just how cognitive, supra note 54. http://dx.doi.org/10.1016/j.cjca.2014.12.019 2015 cosmetic neurocognitive enhancement 761 concomitantly,131 thus increasing the risk of significant side effects. 4. other considerations health care consumers or patients have access to large amounts of health information of varying quality about cosmetic neurocognitive enhancement outside the providerpatient relationship. people also live in an environment shaped by financial factors, social mores, and policies, all of which influence decision-making. these additional factors are of likely equal to greater significance to most health care consumers or patients than provider opinion on the matter. if cosmetic neurocognitive enhancement is not a treatment covered by health insurers or employers then the cost will necessarily fall to the individual. access will be limited to those who can afford to pay for the interventions. this has been a source of ambivalence for providers, who believe that the technologies should be available to consumers as a matter of equality, but who do not believe that enhancement should be covered by third-party payers since they are not medically necessary. the prescription immediate release amphetamines and methylphenidate, which are by far the riskiest of the medications used for neurocognitive enhancement, are also the cheapest and most widely available apart from caffeine. the costs associated with schedule ii drugs are magnified by the 131 sean esteban mccabe et al., non-medical use of prescription stimulants among us college students: prevalence and correlates from a national survey, 100 addiction 96 (2005); laura m. garnierdykstra et al., nonmedical use of prescription stimulants during college: four-year trends in exposure opportunity, use, motives, and sources, 60 j. am. c. health 226 (2012); herman-stahl et al., risk and protective factors for methamphetamine use and nonmedical use of prescription stimulants among young adults aged 18 to 25, 32 addictive behav. 1003 (2007); amelia m. arria et al., nonmedical use of prescription stimulants among college students: associations with adhd and polydrug use, 28 pharmacotherapy 156 (2008); conrad l. woolsey et al., increased energy drink use as a predictor of illicit prescription stimulant use, 13 substance abuse (2014). http://dx.doi.org/10.1111/j.1360-0443.2005.00944.x http://dx.doi.org/10.1080/07448481.2011.589876 http://dx.doi.org/10.1016/j.addbeh.2006.07.010 http://dx.doi.org/10.1592/phco.28.2.156 http://dx.doi.org/10.1080/08897077.2014.969470 762 indiana health law review vol. 12:2 monitoring that many providers will require to prevent harm. health care consumers attempting to make decisions about cosmetic neurocognitive enhancement deserve clear information about benefits and risks. to the extent that cosmetic neurocognitive enhancement is used to navigate difficult social situations, societies are free to make decisions to alter those situations. if educational systems have become so overburdened that classrooms are places of randomness and chaos then a different class structure may be called for, rather than an amphetamine prescription. if there is such a gap between the top schools or workplaces and the next available situation, then it is time to expand the number of favorable educational environments and jobs. if there is recognition that fatigue is associated with significant errors then there could be limits on the numbers of continuous hours that people in high demand and high risk situations are permitted work. and, it might be time to revisit the wisdom of swing shift work. individuals, enhanced or not, should be exposed to a broader range of options that allow for both the ability to make a living and the opportunity to sleep adequately. given that they are not, a place for cosmetic neurocognitive enhancement is a part of the landscape of choices that people have in coping with the less than optimal situations with which they are faced. public policies that discourage drug use in the work or educational environment tend to reduce the number of individuals reaching for cosmetic neurocognitive enhancement by prohibited substances, be they the cosmetic agents specifically or the substances of abuse that may occasion cosmetic use. though some may be over-reaching, these policies are generally because of the significant overlap between non-medical users and individuals with substance use disorders, who tend to escalate dose and use many stimulant substances at the same time, 132 without 132 hartung, supra note 50, at 835-40; nat’l inst. on drug abuse, nat’l inst. of health, u.s. dep’t of health & human serv., research report series: prescription drug abuse 1, available at http://www.drugabuse.gov/publications/research-reports/prescriptiondrugs/stimulants/it-safe-to-use-stimulants-other-medications. 2015 cosmetic neurocognitive enhancement 763 apparent increase in achievement.133 in addition to policies that discourage drug use, effective screening for individuals at risk for substance dependence and time-limited trials of potentially addicting medications are ways to minimize this risk. the increase in u.s. production of amphetamine stimulants has caused worldwide concern for control of illicit amphetamine production and distribution. several commentators have noted that the worldwide amphetamine problem cannot be addressed until the prescription of amphetamine substances is curbed by restricting indications, limiting production, or developing alternatives to amphetamines. though not completely without risk, sustained release and transdermal preparations likely decrease dose escalation and are less attractive agents for diversion. additionally drugs such as modafinil may represent a promising prototype for a non-amphetamine stimulant. over time others will likely be developed, particularly if quotas remain in place or tighten. v. recommendations for providers and systems cosmetic neurocognitive enhancement is not new. human beings have been using substances to this end for centuries, and some of these substances require the participation of a health care provider. since many conditions in neurology and psychiatry are based on self report and subjective disability, the issue at this juncture is not whether or not “normal” individuals receive prescribed products for enhancement but involve the process necessary to use these agents safely and the costs associated with such use.134 neuroscientific advances in delineating likely drug 133 united nations office on drugs and crime, the nonmedical use of prescription drugs: policy direction issues, discussion paper 17 (2011), available at http://www.unodc.org/ documents/drug-prevention-and-treatment/nonmedical-useprescription-drugs.pdf. 134 daniel s. rizzuto & joshua w. fost, transhumanism and cognitive enhancement, in j. w. haag et al., the routledge companion for religion and science 569-77 (j. w. haag et al., eds. 2012). 764 indiana health law review vol. 12:2 effects in given neurobiological systems in various human populations may eventually allow for personalized cosmetic neurocognitive enhancement in which a provider could communicate specific benefits and risks, along with detailed information about trade offs, to the patient or requestor. such advances could also inform policy that would be helpful in defining who should receive cosmetic enhancement, which situations merit cosmetic enhancement, and how patients, consumers, or requestors should access cosmetic neurocognitive enhancement. 135 until such advances occur, individual providers will deal with individual requests in systems with varying standards of practice. given the very wide variability in provider attitudes, beliefs, and practices concerning cosmetic neurocognitive enhancement,136 the health care consumer or patient may receive different answers from different providers about cosmetic neurocognitive enhancement even if the same safety and efficacy data are available to all providers.137 this difference in how the individual provider balances the probabilities that the intervention will meet the patient’s expressed need, will be used as intended, and will not result in unacceptable side effect burden cannot be regulated. this behavior is the practice of medicine. the provider is under no ethical imperative to provide cosmetic neurocognitive, nor is there any legal or ethical bar to doing so.138 there is nothing to suggest that this decision is so qualitatively different from other medical decisions that it merits special training, prohibitions, or rules. while there is not a per se ethical bar to the use of medications for cosmetic neurocognitive enhancement, the risk-benefit 135 maslen, supra note 47. 136 megan brooks, experts clash over cognitive enhancers for healthy people, medscape (dec. 24, 2012), http://www.medscape.com/ viewarticle/776683, archived at http://perma.cc/du28-rknw. 137 hotze et al., doctor, supra note 15, at 3-13; see also c. verster & a a van niekerk, moral perspectives on stimulant use by healthy students, 102 samj 909, 909-11 (2012). 138 dan larriviere et al., responding to requests from adult patients for neuroenhancements: guidance of the ethics, law and humanities committee, 73 neurology 1406 (2009). http://dx.doi.org/10.7196/samj.6090 http://dx.doi.org/10.1212/wnl.0b013e3181beecfe 2015 cosmetic neurocognitive enhancement 765 analysis of currently available technologies should be carefully considered.139 what follows is a proposed practice guideline to inform practice. the process described is time and labor intensive. it will likely also involve the use of a multi-disciplinary team to be efficient and successful. while it is always tempting in busy medical practices to take short cuts, this process relies on meaningful communication between provider and health care consumer or patient. the indeterminacy in the gains and magnitude of the risks involved with cosmetic neurocognitive enhancement are sufficiently high to merit the time, energy, and expense.140 1. listen carefully to the request. explore goals and expectations of treatment. 2. perform a thorough diagnostic evaluation including baseline quantification of attention and concentration, objective personality testing, and screening for otc stimulant use and substance misuse. 3. consider the relative contributions of mismatched expectations, social stresses, and treatable illness to the perception of less than optimal cognition and encourage the individual to address as many of these factors as possible prior to prescribing medications for the purpose of cosmetic neurocognitive enhancement. 139 cynthia forlini et al., should physicians prescribe cognitive enhancers to healthy individuals?, 185 can. med. ass’n j. 1047, 104750 (2013) [hereinafter forlini, should physicians prescribe]; matthis synofzik, ethically justified, clinically applicable criteria for physician decision-making in psychopharmacological enhancement, 2 neuroethics 89, 89-102 (2009). 140 recall that feigning symptoms to secure a prescription for stimulants is more common than previously believed, emergency department mentions are increasing among adults using stimulants, prescription users typically use other substances, family and friends are the most common source of diverted stimulants, and almost two-thirds of students prescribed stimulants for adhd admitted to diverting them. http://dx.doi.org/10.1503/cmaj.121508 http://dx.doi.org/10.1007/s12152-008-9029-1 766 indiana health law review vol. 12:2 4. provide evidence-based education about cognition and cognitive enhancement. the long-term maintenance of wellness (nutrition, sleep, exercise, socialization, education, and avoidance of toxins and trauma) is most associated with optimal cognition and should be a precondition of cosmetic neurocognitive enhancement using prescribed medications. 5. provide education concerning the likely effects and side effects of proposed medications for cosmetic neurocognitive enhancement, as well as the cognitive and emotional tradeoffs likely involved in their use. assess whether requestor expectations align with reasonably foreseeable drug effects. 6. be transparent about the risks and costs of these medications including the expected side effects, need for frequent follow-up and likely out-of-pocket costs for both the medication and the necessary monitoring. 7. be clear with the requestor and third-party payer about the indication for the drug and document thoroughly concerning the offlabel use of the medication for cosmetic enhancement of cognition. 8. plan a short initial trial of medications with monitoring of specific target symptoms before, during, and after the provision of prescribed medications for cosmetic neurocognitive enhancement. review this data with the patient-consumer prior to initiating longer-term treatment at an agreed upon dose and follow-up interval. 9. consider a treatment contract with continued prescription of the stimulant dependent upon use of a single provider, compliance with appointment schedule, optimization of non-medication 2015 cosmetic neurocognitive enhancement 767 interventions, and abstinence from drugs of abuse or dependence as evidenced by a negative urine drug screen. monitor for dose escalation and consider prompt discontinuation if this occurs or if the prescribed substance is combined with other stimulants. 10. avoid the use of immediate release amphetamines and methylphenidate for cosmetic neurocognitive enhancement. individual factors may be sufficient to tip the balance in favor of prescribing sustained release preparations, transdermal preparations and modafinil, all of which come with lower risks of side effects and abuse liability. 11. evaluate each medication and technology purporting to be useful in cosmetic neurocognitive as it emerges and gauge effectiveness against likely placebo effect and non-pharmacologic strategies for enhancement. the provider has a responsibility to act according to his or her professional expertise and conscience in forming interventions for the health care consumer or patient that have the highest probability of success with the lowest risk of harm. vi. conclusion while the practice of cosmetic neurocognitive enhancement is both legally and ethically permissible, the cosmetic use of currently existing prescribed stimulant medications is unlikely to meet the expectations of health care consumers, patients, or providers or to achieve the lofty goals of societal benefit sometimes proffered as justification for the practice. however, sufficient indeterminacy exists in the purpose of health care, definition of disability, and individual circumstances that providers may wish to offer 768 indiana health law review vol. 12:2 cosmetic neurocognitive enhancement to those requesting it. as time goes on, more pharmaceutical products and technologies will enter the marketplace with the goal of cosmetic neurocognitive enhancement. it is incumbent on providers considering the use of these technologies for cosmetic purposes to research the products fully, develop an approach to deliver the service consistently to those requesting it, and discharge the gatekeeper function. i. introduction ii. neurocognitive enhancement in health care iii. requests a. neuromyths facilitating requests b. direct-to-consumer advertising as a driver of patient requests c. so what is it that people do (and do not) want to alter? iv. responses: provider issues a. models of provider-patient interactions b. provider attitudes about enhancement c. availability of enhancing drugs (off-label prescribing) d. currently available enhancing drugs 1. schedule ii drugs 2. schedule iv drugs 3. otc drugs 4. other considerations v. recommendations for providers and systems vi. conclusion http://dx.doi.org/10.18060/3911.0001 exposing the myth of consent jennifer a. drobac* and oliver r. goodenough** 1. introduction ................................................................. 472 a. legal defaults can be useful but need to complement reality ............................................................................. 474 b. goals of this article ................................................... 477 ii. application of the radical neoclassical approach to consent can lead to injustice, ambiguity, and predation .......................................................................... 480 a. consent by teenagers or sexual exploitation? ........ 480 1. doe v. starbucks, inc. ............................................. 482 2. the radical neoclassical approach to “consenting” teenagers .................................................................... 485 b. capacity and consent by elders and disabled persons ......................................................................................... 485 c. “click-through” consent by software users ............ 487 d. the class list goes on and on ................................ 489 iii. justifications and critiques of the radical neoclassical vision of consent .................................... 491 a. morality and philosophy ........................................... 492 b. economic justifications ............................................. 494 c. combining economic and philosophical justifications: a rawlsian exploration ................................................. 500 d. the challenge of “autonomy” ................................... 502 iv. the neuroscience and psychosocial studies of decision making by diverse populations and in a variety of contexts ........................................................ 504 a. neuroscience of decision making .............................. 504 * professor of law, indiana university robert h. mckinney school of law. j.s.d., stanford law school. my sincerest gratitude to miriam murphy, director of the iu mckinney, lilly law library, susan david demaine, research librarian, and jessica april dickson, research assistant for their research assistance. i encourage readers to send their comments to me at jdrobac@iu.edu. ** professor of law, vermont law school, adjunct professor, thayer school of engineering, dartmouth college. my email address is ogoodenough@vermontlaw.edu. 472 indiana health law review vol. 12:2 b. anger and decision making ...................................... 507 c. decision making about organ donation by grieving relatives ......................................................................... 508 d. effects of stress on financial decision making in aging persons ................................................................. 510 e. effects of consumer apathy and other factors regarding click through agreements .......................... 513 f. other studies involving decision making ................ 514 g. the person or the situation: which comes first in the corruption of consent? .................................................. 517 v. addressing the myth of consent with traditional and neurojuridical tools .............................................. 518 a. historical legal approaches to the myth of consent519 1. historical approaches to cognitive incapacity ..... 519 2. historical approaches to volitional incapacity ..... 522 b. traditional tools ........................................................ 524 1. consent enhancers ................................................. 524 2. consent buffers and frames .................................. 526 c. a new neurojuridical tool—legal assent ............... 528 vi. conclusions ................................................................ 530 1. introduction consent is a critical concept for law. private law often rests upon the ability of people to create binding changes of legal status, rights, and obligations. contract, property, and tort law, for instance, all create opportunities for a legal actor to make such changes, whether through binding promises, changes of ownership, or the waiver of claims or defenses. the ability of a particular actor to make such changes is often evaluated in terms of whether consent has been given. that, in turn, depends on the capacity of the actor to give consent. however, our prevailing legal and social conceptions concerning capacity run in tension with reality. on the one hand, an artificial presumption of substantial and un-buffered adult capacity for binding consent is useful for ease of legal administration and social organization. on the other hand, the reality of flawed information, inexperience, a lack of attention, and cognitive 2015 exposing the myth of consent 473 disabilities all too frequently put the lie to that presumption of perfect adult capacity. notwithstanding the plentiful evidence of human limitation, the law makes the most radical vision of unfettered capacity and consent the default rule. we, the authors, believe this vision is better viewed as a special case. a more nuanced view of our actual capacities rests, in part, on the understanding neuroscience provides. this perspective suggests that we should match our rules and jurisprudential approaches to the variable capacities that we all show in different contexts and stages of life. such a view helps jurists to develop and deploy effective enhancers and buffers around consent that reflect a more realistic treatment of capacity. we take a hard look at the myth of consent to add some of the tools and insights of cognitive neuroscience and social psychology to the traditional staples of psychology, economics, politics, and philosophy. and we proffer innovative approaches, such as the framework of legal assent, explored in prior work and summarized in this article.1 1 professor drobac has been exploring the myth of consent with respect to juveniles since 2004. see jennifer a. drobac, sex and the workplace: “consenting” adolescents and a conflict of laws, 79 wash. l. rev. 471, 472 n.4 (2004) [hereinafter sex and the workplace]; jennifer a. drobac, “developing capacity”: adolescent “consent” at the workplace, at law, and in the sciences of the mind, 10 u.c. davis j. juvenile l. & pol’y 1, 3 n.7 (2006) [hereinafter developing capacity]; jennifer a. drobac, a bee line in the wrong direction: science, teenagers, and the sting to “the age of consent”, 20 j.l. & pol’y 63, 65 n.9 (2011) [hereinafter “bee line”]; jennifer a. drobac, wake up and smell the starbucks coffee: how doe v. starbucks confirms the end of the “age of consent” in california and perhaps beyond, 33 b.c. j.l. & soc. just. 1, 2 (2013) [hereinafter wake up]. along with this inquiry came the understanding of the law’s presumption of the “on/off” switch of juvenile capacity and the notion of legal assent. see “bee line” at 113; wake up at 41; jennifer a. drobac & leslie a. hulvershorn, the neurobiology of decision-making in high risk youth & the law of consent to sex, 17 new crim. l. rev. 502, 522 n.57 (summer 2014) [hereinafter the neurobiology of decision-making]; jennifer a. drobac, sexual exploitation of teenagers: adolescent development, discrimination, and consent law (univ. of chi. press forthcoming 2015) [hereinafter sexual exploitation of teenagers]. 474 indiana health law review vol. 12:2 we recognize that our discussion of consent will involve some conflation of not fully equivalent doctrines and modes of analysis. ideas about consent are deeply intertwined with such related topics as the keeping and enforcement of promises, contract formation, waiver of existing rights, and the transfer of property. these related topics are all part of a cognitive cluster around a set of attitudes and assumptions on human agency. the elements in this cluster range from highly formal economics to relatively simplistic “folk psychological” principles. 2 their wide acceptance supports the idea of radical consent as the appropriate “default” approach to the law of binding action. in our discussions, we will take the license that the somewhat diffuse nature of our target provides. we examine elements of this cluster without necessarily parsing the strands of connectivity and the points of comparison and distinction that we would make in a more comprehensive treatment or monograph. a. legal defaults can be useful but need to complement reality we recognize that legal defaults and presumptions have their utility. they reflect political, philosophical, and cultural perspectives and in some cases make the operation of law more efficient. for example, in criminal law, americans assume that the accused is innocent until proven guilty. 3 this default assumption reflects people’s shared perception that the law should give people accused of a crime the benefit of the doubt and assume an original professors drobac and goodenough join together on this project to examine the myth of consent in other contexts and to broaden the application of legal assent. 2 see, e.g., stephen morse, determinism and the death of folk psychology: two challenges to responsibility from neuroscience, 9 minn. j. l. sci. & tech. 1 (2008). in this and other related articles, professor morse explores the folk psychological models of agency and capacity in the context of criminal law, and concludes that these models are “safe” from the challenge of neuroscientifically informed psychology. 3 e.g., coffin v. united states, 156 u.s. 432 (1895). 2015 exposing the myth of consent 475 position of innocence. this default also provides an efficient starting point for all parties such that the prosecution must prove criminal guilt beyond a reasonable doubt.4 criminal law also has default assumptions around the concepts of agency and responsibility that have some correspondence to the questions of civil capacity and consent that we examine here. these criminal law concerns have previously attracted significant attention from scholars applying neuroscientific reasoning to legal doctrine.5 on the whole, however, we feel that the strategic questions governing the application of third party punishment that underlie the criminal doctrines are different from the questions of how people bind themselves by their declarations and actions in the civil context. this paper focuses on civil law, and we will not undertake a review of the criminal law discussions in this context. indeed, the intersection of law and neuroscience has been limited by a predominant attention to questions of criminal law. the symposium that gave rise to this paper and its companions in this issue had a refreshing focus on civil matters. of course, civil law also has its common defaults—and the capacity to consent is one of them. historically, our society has assumed that mature adults have the capacity to give legal consent immediately and permanently, applicable in many contexts under the law. consent, as we use it, refers to the ability of an actor to irrevocably change her position before the law with respect to some aspect of her rights, duties, or status. consent may be explicit or inferred from conduct. thus, legal consent indicates understanding and agreement to a proposed interaction. consequences flow from a breach or action inconsistent with consent. the whole system can produce results as trivial as 4 id. 5 see, e.g., amanda c. pustilnik, violence on the brain: a critique of neuroscience in criminal law, 44 wake forest l. rev. 183 (2009) (critiquing claims concerning the neurobiology of criminal violence and suggesting appropriate using of neuroscience in criminal law). 476 indiana health law review vol. 12:2 the obligation to pay for a bottle of soda or as life changing as the relinquishment of rights worth millions of dollars. a number of reasons justify the recognition and enforcement of such a potentially radical action. for many people, the idea that one’s word is one’s bond is a matter of deeply ingrained cultural or even religious conviction. as such, legal consent reflects our presumption that society can and should hold an adult accountable for her consent, her “word.” at a more theoretically grounded level of justification, neoclassical economists assume that informed, autonomous actors strike welfare-maximizing bargains through free contracting. these actors exchange bargainedfor consent to arrive at efficient, productive deals, often demonstrating “pareto efficiency.”6 the starting assumption that legal actors can bind themselves quickly and permanently reflects a judgment that mature adults are rational actors. adults are capable of gathering and processing information fully and determining their will freely. they so engage with a clear understanding of both short and long term consequences and values. milton freedman—perhaps the archetype of the neoclassical economist—recognized this kind of actor in his declaration: “the possibility of coordination through voluntary cooperation rests on the elementary—yet frequently denied—proposition that both parties to an economic transaction benefit from it, provided the 6 michael j. trebilcock, the limits of freedom of contract 7 (1973); roy weintraub, neoclassical economics, the concise encyclopedia of economics (2007), available at http://www.econlib.org/library/enc1/neoclassicaleconomics.html (last visited apr. 5, 2015); see also vilfredo pareto, manuel d’économie politique (1909); john s. chipman, pareto: manuel of political economy, available at http://www.econ.umn.edu /~jchipman/dalloz5.pdf (last visited apr. 5, 2015). the use of the term “neoclassical economics” throughout this article is a useful, and commonly adopted, shorthand to describe a particular school of thought. neoclassical economics frequently has more nuance than is ascribed in our text. we note that trebilcock makes use of this shorthand description in his important and widely cited work on contractual limits. 2015 exposing the myth of consent 477 transaction is bilaterally voluntary and informed.”7 jurists, in turn, frequently assume this perfect contracting machine as the human baseline for much of our law of consent. arguably, such assumptions have provided us with a predictable and efficient basis for operation in ordering relations between individuals, organizations, and groups, allowing the possibility that freedman invokes. just as arguably, however, these assumptions can result in predation, unfairness, and devastating unintended consequences. a legal tool as powerful as permanently binding consent needs to be nuanced, reality-based, and applied with care. b. goals of this article this article, an introduction to the authors’ broadening research agenda, challenges the legal default of unquestioned human capacity for consent. it posits that legal capacity for consent is not an “on/off” switch. it questions the notion that capacity—our rough filter for the ability to consent—flips on at some relatively arbitrary time that one might, as a matter of tradition, call “the age of consent,” and off again with early onset dementia or alzheimer’s disease. by highlighting that most negotiating parties, in a given moment or context, may possess rather less than legally presumed capacity to consent, this article emphasizes the need for legal reform. rather than radical change, the article recommends systemic application of existing and newly devised tools to establish a more nuanced approach to our recognition of consent. a nuanced approach facilitates interpersonal interactions with much of the same efficiency and rather less of the potential for abuse that exists in more radically absolute ideas of consent. some of these tools are already in use. for example, the “infancy defense” in contract law, which makes contracts voidable by “consenting” minors, has existed for hundreds of 7 milton freedman, capitalism and freedom 13 (1962) (emphasis added); see also trebilcock, supra note 6, at 7. 478 indiana health law review vol. 12:2 years.8 however, jurists have not thought of these legal devices as neurojuridical tools because neuroscientific discoveries have only recently begun to confirm the psychosocial evidence that contradicts common assumptions about consent and capacity. 9 neuroscience shows how juveniles, elders, and many contracting adults may lack specific capabilities while possessing others. when people understand that brain function affects decision making, jurists can use neuroscience to discern better how incomplete functional capacity may influence legal capacity. additionally, neurojuridical tools highlight when jurists may recognize legal consent or when they should identify a new action, legal assent, a legal reform that requires no presumption or existence of legal capacity. part ii begins by setting out a few concrete examples that demonstrate how the more radical “neoclassical approach” to consent disserves many populations, including not only the young and old, but all people, depending on the contexts. for example, healthy adult actors who have less bargaining power or information than their relational partners encounter disadvantages in an un-buffered free market world. this section introduces some of the confusion one finds in the way the law currently addresses capacity and decision-making limitations. part iii explores some of the justifications offered for the wide application of a radical neoclassical vision of consent. it also offers critiques of these justifications and sets out affirmative arguments for a more nuanced approach to issues of consent. in a number of these arguments, we anticipate how neurojuridical tools, based on a better understanding of the cognitive and psychosocial capacities that shape and limit an ability to consent, can help jurists to create better solutions. part iii suggests that in a just society parties maintain a framework of un-waivable duties that they owe each other in order to prevent predation and 8 see restatement (second) of contracts § 12(2)(a) (1981). 9 e.g., michelle baddeley, herding, social influence and economic decision-making: socio-psychological and neuroscientific analyses, 365 phil. trans. r. soc. 281, 286 (2010). see discussion infra part iv. http://dx.doi.org/10.1098/rstb.2009.0169 2015 exposing the myth of consent 479 abuse. in such a society, bounded consent, or perhaps legal assent, can better foster the structure of reliable expectations on which social and economic interactions depend. part iv explores how neuroscience and psychosocial evidence contributes to an understanding of developing, declining, and limited legal capacities that produce mythical consent. in particular, this section examines a few specific studies that explore what might be happening in an actor’s brain that arguably compromises a transaction or taints the legal significance of the consent proffered. part iv demonstrates how scientific evidence can inform an understanding of these fraught bargains. scientific evidence sheds light on the reality of human capacities rather than merely asserting some imagined ideal human actor. part v begins with an analysis of how traditional law has buffered, qualified, or even disregarded, in a fragmented manner, the radical neoclassical consent myth and approach under certain circumstances. examples include coercion, undue influence, discrimination, breach of fiduciary duty, incapacity, and other compromising factors. part v then explores new legal tools for dealing with the relinquishment of rights, duties, and status. in particular, it reviews legal assent, a mechanism that presumes no threshold legal capacity but affords teenagers, the declining elderly, and other adults both autonomous decision-making authority and protection following misguided decisions. in sum, we demonstrate that presumed capacity taints bargains made by at-risk individuals, a class that includes all of us depending on the context. the strategic recognition and use of neurojuridical tools identifies at-risk parties and circumstances and sheds light on the problematic nature of consent offered on some occasions. legal reforms prompted by that enlightenment will facilitate optimum consensual relations and ultimately foster the pareto enhancing goals, now mistakenly linked to a more radical vision of consent. 480 indiana health law review vol. 12:2 ii. application of the radical neoclassical approach to consent can lead to injustice, ambiguity, and predation a neoclassical approach to contract generally assumes that parties have equal bargaining power and access to information. through rational negotiations, these parties arrive at a mutually beneficial pareto optimum. the beauty of this approach to contracting is that the parties exercise their autonomous choices freely to maximize what they respectively value through the bargain. the problem is that the neoclassical model does not always reflect reality. a. consent by teenagers or sexual exploitation? one situation in which the freedom to consent leads to problematic bargains involves adolescent consent to sex with an adult, for example, a teacher or a work supervisor. the radical neoclassical approach assumes equal knowledge, power, and operational freedom. when the actors consent, the neoclassical model affords both actors binding authority. however, teenagers may not have the experience, information, authority, or freedom that their adult consorts enjoy.10 the neoclassical assumptions do not account for such variation. laws treat these teenagers inconsistently. sometimes statutes credit them with adult legal capacity to contract and sometimes laws treat them as infants. for example, 10 for a thorough, detailed, and updated discussion of the neurological and psychosocial development of teenagers, see sexual exploitation of teenagers, supra note 1. see also jennifer a. drobac, consent, teenagers, and (un)civil(ized) consequences, in children, sex and the law (ellen marrus & sacha coupet eds., forthcoming 2015) [hereinafter (un)civil(ized) consequences]; jennifer a. drobac, i can’t to i kant: the sexual harassment of working adolescents, competing theories, and ethical dilemmas, 70 alb. l. rev. 675, 713–17 [hereinafter i can’t to i kant]; see generally developing capacity, supra note 1, at 1. 2015 exposing the myth of consent 481 until a teenager has reached the “age of consent,” 11 statutory rape law may apply to erase any defensive meaning (for the adult perpetrator) that adolescent consent carries.12 thus, consent is no defense and it has no legal influence. even as criminal law may invalidate the legal significance, however, civil law might credit adolescent consent to bar the teenager from recovery for her injuries under tort or antidiscrimination law. 13 has the actual capacity of the minor changed between these two contexts? clearly not. no matter. as between the same actors, acts, and situation, the law gives “consent” multiple meanings. however, none of these separate meanings accurately captures the nuances of the minor’s overall developing 11 the “age of consent” commonly refers to the age at which a minor (someone under eighteen years old) may legally consent to engage in sexual activity with an adult and, thereby, insulate that adult from criminal prosecution. see age of consent, wiktionary, en.wiktionary.org/wiki/age_of_consent (last modified apr. 28, 2015 06:49 pm) (“[age of consent] is used to indicate the age at which it is no longer a crime for someone else to engage in consensual sexual intercourse with the person who is still younger than the age of consent . . . .”) (emphasis omitted). but see donaldson v. dep’t of real estate, 36 cal. rptr. 3d 577, 588–89 (cal. ct. app. 2005) (noting while “age of consent” has often been used by courts “as shorthand for the age below which . . . sexual relations would support a charge for statutory rape,” the phrase may refer to the age at which a minor can legally consent to marry). 12 see, e.g. cal. penal code § 261.5(a) (west supp. 2012) (prohibiting unlawful sex with a minor); ages of consent in north america, wikipedia: the free encyclopedia, http://en.wikipedia.org/wiki/ages_of_consent_in_north_america (last modified apr. 29, 2015, 7:38 pm); worldwide ages of consent, avert, http://www.avert.org/age-of-consent.htm (last visited apr. 5, 2015). 13 for list of states in which state civil and criminal law treatment of adolescent consent conflict, see drobac & hulvershorn, supra note 1, at 525-26; see also npr staff, criminal law says minors can’t consent—but some civil courts disagree, all things considered (nov. 16, 2014), http://www.npr.org/player/v2/mediaplayer.html ?action=1&t=1&islist=false&id=364538087&m=364561418 (interviewing professor drobac about a sexual abuse case involving a student in the los angeles unified school district and the conflicts between california state criminal and civil laws). 482 indiana health law review vol. 12:2 capacity.14 criminal law invalidates her consent; civil law credits her consent. 1. doe v. starbucks, inc. the california matter involving jane doe, timothy horton, and starbucks demonstrates this multiple and conflicting assignment of meaning.15 in 2005, twenty-fouryear-old timothy horton worked as doe’s supervisor at starbucks. they allegedly engaged in sexual activity after horton made “perhaps hundreds” of profane, sexually explicit remarks concerning his sexual interest in this sixteen-year-old subordinate barista.16 doe argued that she had initially spurned his attention but that she finally acquiesced, hoping that he would stop.17 doe explained: [horton] demanded that i perform oral sex on him, which i did. i felt like i had to—that i had no choice. . . . i felt that, because he had given me marijuana and i had smoked it with him, i had to do what he said, because he was my supervisor and i didn’t want to lose my job.18 14 in 2004, professor drobac first introduced the notion of “developing capacity.” sex and the workplace, supra note 1, at 518-19 (distinguishing the concept from “diminished capacity” because “diminished” carries a negative connotation and suggests that capacity should exist or may once have existed, and arguing, “[m]ost teenagers suffer not from impairment but from immaturity—a blameless condition and a natural phase of growth.”) 15 see drobac, wake up, supra note 1, at 29-32. 16 doe v. starbucks, inc., no. sacv 08-0582 ag (cwx), 2009 wl 5183773 *2 (c.d. cal. dec. 18, 2009) (quoting starbucks’s objections to plaintiff’s evidence at 9:9–10:8, doe v. starbucks, inc., no. sacv 080582 ag (cwx), 2009 wl 5183773 (c.d. cal. dec. 18, 2009)). 17 id. at *1, *4 (citing doe declaration ¶ 4, doe v. starbucks, inc., no. sacv 08-0582 ag (cwx), 2009 wl 5183773 (c.d. cal. dec. 18, 2009)). 18 starbucks, 2009 wl 5183773, at *3, *4 (quoting doe declaration ¶ 20, doe v. starbucks, inc., no. sacv 08-0582 ag (cwx), 2009 wl 5183773 (c.d. cal. dec. 18, 2009)). doe and horton engaged in sexual activities regularly through june 2006. id. at *5. in addition to 2015 exposing the myth of consent 483 horton pressured doe to keep their relationship a secret.19 in 2006, however, doe told her mother and quit starbucks to check into a mental health treatment facility.20 california law treated doe’s consent to sex with horton in completely inconsistent ways. “horton pleaded guilty to a criminal charge of unlawful sexual intercourse with a minor under 18.”21 in that criminal case charged under california penal code section 261.5, doe’s consent was no defense to the strict liability offense. presumably, california ignores the minor’s consent because legislators believe that minors do not possess the requisite capacity to consent. 22 doe brought a parallel civil claim against starbucks and horton, however, for sexual harassment and tort claims.23 in the 2009 doe v. starbucks, inc. decision, the california federal trial court determined that doe’s consent to sex with her supervisor merited legal recognition.24 same people, same conduct, same consent, but criminal and civil law dictated different legal treatment. the starbucks court relied on dictum from a 2001 california supreme court incest decision, people v. “‘vaginal intercourse and oral copulation’” at work and offsite, “‘[t]hey ex-changed explicit sexual comments and text messages at work.’” id. (quoting plaintiff’s statement of material facts ¶¶ 20, 25, doe v. starbucks, inc., no. sacv 08-0582 ag(cwx), 2009 wl 5183773 (c.d. cal. dec. 18, 2009)) [hereinafter psmf]. 19 id. at *5. 20 starbucks, 2009 wl 5183773, at *5, *6 (citing doe declaration ¶ 4, doe v. starbucks, inc., no. sacv 08-0582ag (cwx), 2009 wl 5183773 (c.d. cal. dec. 18, 2009) and psmf, supra note 18, ¶ 59). 21 id. at *6 (citing psmf, supra note 18, ¶ 63); see cal. penal code § 261.5(a) (west supp. 2012). 22 see michelle oberman, regulating consensual sex with minors: defining a role for statutory rape, 48 buff. l. rev. 703, 710 (2000); tara l. pennington, doe 1 v. city of murrieta: how the california court of appeal missed the mark on vicarious liability for sexual torts committed by on-duty police officers, 37 u.s.f. l. rev. 1091, 1108 (2003). 23 starbucks, 2009 wl 5183773, at *6. 24 id. at *7–8; see donaldson v. dep’t. of real estate of state of cal., 36 cal. rptr. 3d 577, 589 (2005). 484 indiana health law review vol. 12:2 tobias,25 in making its decision. certainly, doe argued that penal code section 261.5 confirmed that she did not have the capacity to consent.26 the starbucks court disagreed quoting tobias that “in some cases at least, a minor may be capable of giving legal consent to sexual relations.” 27 acknowledging that tobias was a criminal case, the starbucks court opined that its rule had been extended to civil cases by donaldson v. department of real estate of state of california.28 the donaldson court had reasoned that in drafting section 261.5 separate from the rape statute, penal code section 261, the california legislature had abolished statutory rape as a crime. the donaldson court opined, “just as there is no longer any ‘statutory rape’ in this state, so there is no ‘age of consent’ as concerns sexual relations, and references to such a concept can only muddy the analytical waters.”29 thus, in 2005, the same year that horton seduced doe, the donaldson court determined that there was no “age of consent” in california. the starbucks court simply followed established california case law precedent. so much for the “on” switch of legal capacity. did doe have the same information and experience as her twentyfour-year-old supervisor? did she wield the same bargaining power and authority? was theirs a mutually beneficial and efficient bargain? can a minor of any age consent to sex with an adult in california? under tobias, donaldson, and starbucks, presumably so.30 one wonders if a proponent of the neoclassical school would have seen 25 people v. tobias, 21 p.3d 758, 761 (cal. 2001). 26 starbucks, 2009 wl 5183773, at *7. 27 id. (emphasis omitted) (quoting tobias, 21 p.3d at 762). 28 id. 29 donaldson, 36 cal. rptr. 3d at 589. 30 several california legislators have announced plans to sponsor bills to correct this apparent conflict in laws. paul glickman, kpcc report on lausd sex abuse suit sparks 3 bills on sexual consent in civil cases, 89.3 kpcc, nov. 26, 2014, archived at http://perma.cc/8fgm-ah3d; see also teresa watanabe, state bill would clarify that youth under 18 cannot legally consent to sex with adults, l.a. times, dec. 1, 2014, archived at http://perma.cc/ram4e7by. 2015 exposing the myth of consent 485 pareto efficiency in the starbucks result, and if so, which one—the criminal or the civil? 2. the radical neoclassical approach to “consenting” teenagers starting from a neoclassical perspective could lead some to argue that adolescents who consent to sex with an adult deserve—and, indeed, have bargained for—the resulting consequences. positive resulting consequences might include: emotional intimacy, satisfying sex, social prestige, mentoring, and other employment or academic benefits. skeptical analysts may hypothesize that the risks of a harmful bargain and injury for the teenager far outweigh those for the arguably more capable adult. negative consequences might include: unwanted pregnancy (note that california penal code section 261.5 is “the teenage pregnancy prevention act of 1995”), the transmission of sexual diseases, social condemnation, and psychological distress, among other harms. thus, the neoclassical model may not assure an efficient or optimal bargain between an adult and a minor. criminal prosecution and civil liability for personal injuries (in states that permit recovery for civil harms), not to mention social disapproval of sexually active youth, mediate against the efficiency and optimality of an unbounded sexual bargain between a teenager and an adult. b. capacity and consent by elders and disabled persons elders and disabled persons also encounter legal problems concerning their capacity and consent. gerontologists understand, for example, that elders may display reasonable decision-making skills during the day but experience a condition known as “sundowning” as evening approaches. at the end of the day, an elder’s capacity may decline, and the person may become 486 indiana health law review vol. 12:2 disoriented and confused.31 thus, an elder may have the “capacity” to make certain decisions at noon, but not at 9 p.m. legal issues for elders become even thornier after a court adjudges a person incompetent. similarly, disabled persons may have inconsistent capabilities or the ability to engage in some activities but not in others. consider, for example, diane belinky. in 1994, diane belinky suffered a debilitating stroke at the age of fifty-two.32 paralyzed and barely able to speak, she entered the drake center, a nursing care facility.33 her husband of thirty years, barry belinky, visited her daily during visiting hours but then petitioned for overnight visitation. the facility denied his request, asserting that if he sexually molested his wife and she regained capacity, she could sue the nursing facility. despite the fact that mr. belinky sought the opportunity to comfort his wife in the evening, not engage in sexual relations, drake continued to deny his request. noting advice from legal counsel, drake referred to competence, the absence of consent, and rape case law. the appellate court reversed and held, “that a question of fact exists as to whether drake had reasonable rules in effect which would have precluded mr. belinky from visiting overnight.”34 a neoclassicist reviewing the belinky case might conclude that as long as diane could express consent, her husband (or anyone else who wanted to have sex with her) was free to proceed. this perspective arguably puts disabled and elderly persons at risk of exploitation by a 31 see generally alzheimer’s association, sleep issues and sundowning, alz.org, archived at http://perma.cc/6mlx-86uk; donald l. bliwise, what is sundowning?, 42 j. amer. geriatrics soc. 10091011 (sept. 1994). 32 sonja barisic, man fighting to spend nights with disabled wife to comfort her, ap news archive, feb. 22, 1996, archived at http://perma.cc/9fgb-qpam. 33 sonja barisic, judge rejects man’s plea to share bed with his wife, southcoasttoday.com, feb. 22, 1996, archived at http://perma.cc/3rrp-zgdb. 34 belinky v. drake center, inc., 690 n.e.2d 1302, 1308 (ohio ct. app. 1996). http://dx.doi.org/10.1111/j.1532-5415.1994.tb06598.x 2015 exposing the myth of consent 487 wide variety of predators, sexual and financial. this approach also begs the question of whether a person, who cannot speak or demonstrate consent reliably, can enter into bargains or a contractual relationship. a negative answer might strip some persons, who may still have mental capacity or partial capacity, of certain rights. one can imagine a myriad other examples of declining, inconsistent, or impaired capacity. when jurists and other professionals can use neuroscience and psychosocial evidence to determine the limits of a person’s decisionmaking capacity, then society should afford aging persons and the disabled as much autonomy as appropriate for the individual. however, scientific inquiry and medical analysis are not always precise or sophisticated enough to allow for clear individualized classifications regarding capacity. moreover, the law’s awkward demarcations fail to account for the biodiversity that exists. therefore, we suggest adapting law to account for the fact that the “off switch” of legal capacity is more like a dimmer or a strobe. fading or on and off sporadically, or both. the two extremes of the age spectrum and the disabled are not the only populations that would benefit from a more nuanced legal treatment of decision-making capacity. we all might benefit, as demonstrated in a study involving computer “click-through” agreements (ctas). c. “click-through” consent by software users in april 2010, thousands of computer game customers found out that they had made a faustian bargain with the uk-based company game station. as an experiment on consumer inattention, game station had inserted into its standard “click through” license form a clause that transferred the consenting party’s immortal soul to the company. just to further make its point, the company offered a reward of £5 to anyone who opted out of the transaction. reports indicate that eighty-eight percent of 488 indiana health law review vol. 12:2 those agreeing to the click through accepted the transfer of the soul; only twelve percent opted for the £5 instead.35 research by nyu law professor florencia marottawurgler and others suggests that the twelve percent figure represents a particularly vigilant population for a cta. their research followed the clickstream of 47,399 households to eighty-one internet software retailers. they measured whether the person about to enter into an internet contract actually clicked on the terms and conditions along with the time spent looking at the terms from those who did call up the terms. they found that “even with prominent disclosure, readership, as conservatively estimated as including all consumers that access the eula page for at least one second, remains less than 0.5%.”36 the probability is that the vast majority of the persons agreeing to terms in this state of complete ignorance are normal adults—the poster-actors for the radical consent model of knowing consent. can the law really bind people in this kind of negligent agreement? the answer, under u.s. decisions is often yes. the seminal 1996 case procd v. zeidenberg37 considered whether “shrink wrap” terms, inside the box in a physical purchase, could bind the parties. judge easterbrook held it could, declaring, “shrinkwrap licenses are enforceable unless their terms are objectionable on grounds applicable to contracts in general (for example, if they violate a rule of positive law, or if they are unconscionable).”38 this logic has been extended in a number of cases to the now classic cta, provided that the formalities of contract formation are reasonably observed.39 certainly, there are 35 joe martin, game station: “we own your soul,” bitgamer (apr. 15, 2010), archived at http://perma.cc/r6ja-6u6v. 36 florencia marotta-wurgler, does disclosure matter? 168 j. inst. & theoretical econ. 94, 97 (2012), available at http://ssrn.com/abstract=1713860 or http://dx.doi.org/10.2139/ssrn.1713860. 37 procd, inc. v. zeidenberg, 86 f.3d 1447 (7th cir. 1996). 38 id at 1449. 39 see, e.g., groff v. america online, inc., file no. c.a. no. pc 970331, 1998 w l 307001 (r.i. superior ct., may 27, 1998) (affirming the http://dx.doi.org/10.2139/ssrn.1713860 2015 exposing the myth of consent 489 efficiency arguments for the extension of contracting through this kind of means. seller reputation concerns and general principles, such as unconscionability, may provide some protection against outright predation. however, no one can reasonably assert that the click of these “consenting adults” exemplifies the kind of informed understanding presumed by default under the radical model of neoclassical consent. d. the class list goes on and on while these examples amply demonstrate the problems that the law encounters from its traditional treatment of consent, the list of potential targets goes on and on. there are clearly difficulties with consent in the medical procedure area, where even legally mandated disclosure falls short of really meeting the goals of the “informed consent” standard. 40 consent given by those under compulsion, such as prisoners, is classically suspect. 41 validity of a click-wrap agreement); hotmail corporation v. van money pie inc., no. c98-20064, 1998 wl 388389 (n.d. cal., april 16, 1998) (holding that defendants were bound by terms of service as a result of clicking on “i agree”). see also register.com v. verio, 356 f.3d 393 (2d cir. 2004) (affirming binding nature of terms of use in a repeat transaction context). but see schnabel v. trilegiant corp., 697 f.3d 110 (2d cir. 2012) (holding a subsequent email of additional terms does not bind the recipient); specht v. netscape, 306 f.3d 17 (2d cir. 2002) (click through agreement to arbitration not binding if the terms not conspicuous) and dunstan v. comscore, inc., no. 11-cv-05807, 2013 wl 6909514 (n.d. ill. dec. 3, 2013) (click through not enforceable when the contracting information was “obscured”). see generally nathan j. davis, presumed assent: the judicial acceptance of clickwrap, 22 berkeley tech l.j. 577 (2007). 40 e.g., paula walter, the doctrine of informed consent: to inform or not to inform?,71 st. john's l. rev. 543 (1997); jaime s. king & benjamin moulton, rethinking informed consent: the case for shared medical decision-making, 2 am. j.l. & med. 429 (2006). see generally culbertson v. mernitz, 602 n.e.2d 98, 103 (ind. 1992). 41 see, e.g., 45 cfr § 46.305 (additional duties of the institutional review boards where prisoners are involved). see keramet reiter, experimentation on prisoners: persistent dilemmas in rights and regulations, 97 cal. l. rev. 501 (2009); daniel r. mendelsohn, the 490 indiana health law review vol. 12:2 consumer credit agreements are notoriously one-sided, a condition that prompted creation of the consumer financial protection bureau.42 as will be discussed more fully below in the context of existing legal buffers and enhancers, the federal trade commission (ftc) has recognized the frequent use of certain predatory tactics in other consumer transactions as well. 43 employers constantly use their greater experience to put waivers, covenants, and transfers of rights into their contracts with prospective employees. most of these job seekers (and especially those who are desperate in a slow economy) just sign on the dotted line with little concept of what they are giving away.44 even in right to refuse: should prison inmates be allowed to discontinue treatment for incurable, noncommunicable medical conditions?, 71 md. l. rev. 295 (2011). but see, sharona hoffman, beneficial and unusual punishment: an argument in support of prisoner participation in clinical trials, 33 ind. l. rev. 475 (2000); david j. moser et al., coercion and informed consent in research involving prisoners, 45 comprehensive psychiatry 1 (2004). 42 creating the consumer bureau, consumer fin. protection bureau, http://www.consumerfinance.gov/thebureau/creatingthebureau/ (last visited apr. 5, 2015). see about us, consumer fin. protection bureau, http://www.consumerfinance.gov/the-bureau/ (last visited apr. 5, 2015) (describing the mission of the cfpb in the following terms: “above all, this means ensuring that consumers get the information they need to make the financial decisions they believe are best for themselves and their families—that prices are clear up front, that risks are visible, and that nothing is buried in fine print. in a market that works, consumers should be able to make direct comparisons among products and no provider should be able to use unfair, deceptive, or abusive practices.”). 43 see infra notes 145-154 and accompanying text. 44 see, e.g., iskanian v. cls transportation los angeles, llc, no. s204302 (cal. june 23, 2014), available at http://www.courts.ca.gov/ opinions/documents/s204032a.pdf (upholding the waiver of class action rights); viva r. moffat, making non-competes unenforceable, 54 az. l. rev. 939 (2012) (criticizing enforceability of employee agreements not to compete); armendariz v. found. health psychcare serv., inc., 24 cal. 4th 83 (2000) (upholding an employment contract that mandated arbitration and invalidated court action for resolution of employment related disputes). see generally craig r. senn, knowing and voluntary waivers of federal employment claims: replacing the totality of circumstances test with a “waiver certainty” test, 58 fla. l. rev. 305 (2005). http://dx.doi.org/10.1016/j.comppsych.2003.09.009 2015 exposing the myth of consent 491 the relatively rarified world of securities and investment decisions by knowledgeable, wealthy individuals, the standard agreements require investors to consent to dispute resolution procedures which can eviscerate many legally mandated protections. “virtually all brokerage firms include provisions in their standard-form customer agreements requiring arbitration of customers’ disputes in the finra [financial industry regulatory authority] forum.” 45 investors routinely agree to these provisions, often with little understanding of the consequences.46 iii. justifications and critiques of the radical neoclassical vision of consent given the mismatch of theory and reality that these examples demonstrate, why do we accept the radical notions of capacity and consent as the starting point in so much of private law? the justifications for such an unrestricted idea of consent fall into several categories briefly summarized here. as noted above, ideas about consent are deeply intertwined with the enforcement of promises, contract formation, and other statements and actions that create legal obligations. these notions about legal obligations are not always identical in definition or function to any particular formulation of capacity and consent. nevertheless, we believe that these notions, whether or not rooted in fact, are part of a cognitive cluster. this cluster underlies the acceptance of the radical idea of consent as the appropriate “default” approach in private ordering. in our review of these justifications, we also note and offer critiques. many of these criticisms have been explored extensively in other contexts, under labels such as “market failure.” we do not claim originality in setting them out, but we do believe that it is time to offer them again. more 45 barbara black & jill i. gross, investor protection meets the federal arbitration act, 1 stan. j. of complex litig. 1, 4 (2012). 46 id.; s.i. strong, contractual waivers of investment arbitration: wa(i)ve of the future? 29 icsid rev.-foreign investment l.j. 690 (2014). 492 indiana health law review vol. 12:2 importantly, we combine them with the cognitive and neuroscientific evidence of the kind set out in section iv. this combination supports our core argument that american law would benefit from a more nuanced concept of consent. a. morality and philosophy first, theorists offer moral and philosophical justifications to support unrestricted consent. in this regard, consent often translates, in the context of a bargain, to serve as a promise. the concept that “my word is my bond” has deep resonance in everyday morality, and not just in the united states and other european traditions.47 it has application across all segments of society. its latin version, “dictum meum pactum,” has served as the motto of the london stock exchange.48 the stanford encyclopedia of philosophy recognizes, “few moral judgments are more intuitively obvious and more widely shared than that promises ought to be kept.” 49 the faithfulness to a mistakenly given, or even predatorily extracted oath, even in the face of a disastrous cost, often has a heroic status in literature, and is rooted deeply in western cultural history, as evidenced by the saga of the jomsvikings. 50 the religious faithful, including the promise keepers, 51 have built huge movements that view promises as devotions to 47 martin hogg, promises and contract law: comparative perspectives (2011). 48 our history, london stock exchange, http://www.londonstockexchange.com/about-the-exchange/companyoverview/our-history/our-history.htm (last visited apr. 5, 2015). 49 allen habib, promises, stanford encyclopedia of philosophy (mar. 4, 2014), archived at http://perma.cc/epv7-2upv (provides a useful expansion on the necessarily terse summary provided here); see also, hogg, supra note 47. 50 lee m. hollander, the saga of the jomsvikings, (siguður nordal & g. turville-petre eds., n. f. blake trans., 1962), archived at http://perma.cc/t3va-kh7c. 51 what, promise keepers, http://www.promisekeepers.org; see also gustav niebuhr, men crowd stadiums to fulfill their souls, n.y times, aug. 6, 1995, archived at http://perma.cc/vj22-wend. 2015 exposing the myth of consent 493 god, if not as sacraments. this simple moral principle that a promise should be kept is a source of the legal idea of binding consent.52 more developed ethical theory also honors the principle that promises are binding.53 legal scholars have credited the pro-promise keeping elements of aristotle and aquinas with providing the intellectual framework for the synthesis of contract law over the eighteenth and nineteenth centuries.54 the emphasis on a binding exercise of “will” in that philosophical tradition, in particular, may provide the basis for contemporary considerations of autonomy and capacity as key elements in the creation of binding consent. 55 contemporary philosophy also seeks justifications for the importance of making and fulfilling bargains.56 in turn, legal scholars have appropriated those justifications. it should be noted that philosophers have also critiqued promise keeping. hume, for example, reacted sarcastically to religiously based arguments on promise keeping and declared: i shall farther observe, that since every new promise imposes a new obligation of morality on the person who promises, and since this new obligation arises from his will; it is one of the most mysterious and incomprehensible operations that can possibly be imagined, and may even be compared to transubstantiation, or holy 52 see, e.g., e. allan farnsworth, changing your mind: the law of regretted decisions (1998); hogg, supra note 47. 53 see, e.g., habib, supra note 49; james gordley, the philosophical origins of modern contract doctrine (1991). 54 gordley, supra note 53 at 3-29. 55 id. at 7-9. 56 john rawls, two concepts of rules, 64 the philosophical rev. 3 (1955); michael g. pratt, promises and perlocutions, crispp: critical rev. of int’l soc. and pol. phil., jun. 2002, at 93-119; t.m. scanlon, what we owe to each other (1998); david p. gauthier, morals by agreement (1986). http://dx.doi.org/10.2307/2182230 http://dx.doi.org/10.1080/13698230410001702612 494 indiana health law review vol. 12:2 orders, . . . where a certain form of words, along with a certain intention, changes entirely the nature of an external object, and even of a human nature.57 the consequentialist/utilitarian tradition in philosophy moves away from the inherent worthiness of bargain keeping to a view of its functionality. enforceable promises provide a framework within which parties can structure arrangements that have good results. such a utilitarian approach bleeds over into exactly the kind of functionalism that informs economic analysis and the justification of contracts. b. economic justifications as introduced above, the principle of a bargained-for exchange between informed, rational, willing actors is central to neoclassical economics. 58 economists have thoroughly explored this topic and we offer only a rough summary of the economic justifications for enforcing promises. some of the arguments in favor of enforcement and support are non-utilitarian. for instance, some theorists assert that the fulfillment and enforcement of voluntary private bargains support personal liberty and autonomy as a general principle. 59 other validations are directly utilitarian. binding consent supports exchanges that produce pareto superiority, where at least one of the parties benefits and neither is worse off. this result demonstrates utility enhancement clear and simple.60 as trebilcock put it: 57 3 david hume, a treatise of human nature pt. 2, § 5 (1738) (emphasis in the original), available at http://www.gutenberg.org/ files/4705/4705-h/4705-h.htm#link2h_4_0022. 58 friedman, supra note 7. 59 e.g., richard a. epstein, design for liberty: private property, public administration, and the rule of law (2011). 60 e.g., jules coleman, efficiency, utility, and wealth maximization, in markets, morals and the law 95 (1988); see, e.g., 2015 exposing the myth of consent 495 [i]f two parties are to be observed entering into a voluntary private exchange, the presumption must be that both feel the exchange is likely to make them better off, otherwise they would not have entered into it. thus, in most exchanges, the economic presumption is that they make all the parties thereto better off, that is, they are pareto superior.61 we note that not all examples of consent as we have broadly defined it here fit fully with the idea of an “exchange.” nonetheless, we believe that the enthusiasm of neoclassical economics for private exchange rooted in this kind of logic is a powerful element in the radical view of consent. we also note that pareto positive transactions might possibly occur without necessarily invoking the ideas of capacity, consent, and obligation that we are examining here. simultaneous exchange, for instance, does not need any kind of contract with a temporal duration. however, even in the case of simultaneous exchange, the element of voluntariness that maps onto consent is still present as a criterion. any non-simultaneous exchange needs some kind of guaranty of temporally sequential action to overcome the possibility of first-mover exposure to second-mover defection. such a guaranty can be variously instantiated in psychology, a physical contraption such as the dual key lock box or classic soda machine, 62 or cultural expectations. additionally, the availability of enforceable, self-binding rights-creation for others in contract, tort, and property is a powerful tool that opens up space for transactions.63 robert cooter & thomas ulen, law and economics 283 (6th ed. 2012); steven shavell, foundations of economic analysis of law 293 (2004). 61 trebilcock, supra note 6, at 7. 62 e.g., oliver r. goodenough, values, mechanism design, and fairness, in moral markets: the critical role of values in the economy 228 (paul j. zak ed., 2008). 63 id. 496 indiana health law review vol. 12:2 we believe, however, that when the rules for recognizing enforceable bargains incorporate not only the power of legally binding consent, but also the criteria on which that power rests, even greater space for transactions develops. when the rules are modified to require buffered and mitigated consent in light of the human cognitive and informational constraints that underlie transactional reality, vast expanses for creative interaction emerge. the recognized criteria for making utilitarian, pareto enhancing exchanges—the likely outcome of private bargaining—are not trivial. while variously stated and enumerated, the criteria may involve: (1) parties with stable, well ordered preferences; (2) choices that are fully voluntary and unconstrained; (3) relatively equal, and ideally complete, information; (4) relatively equal bargaining power and experience; (5) sufficient cognitive capacity to evaluate the transaction and to exercise voluntary control over the conflicting factors and emotions involved; (6) the absence of monopoly power or other distortions of the market; (7) the presence of good faith and absence of fraud in both parties; and (8) a level of consequence for a mistake that is not disastrous to the party.64 given the many factors that must come together to create the “perfect friedman,” if we may call it such, it seems bizarre that philosophers, scholars, and jurists would celebrate unfettered consent as the default state. one can easily predict the failure to meet all criteria. the likely effect of such failure is that the party with greater knowledge, experience, or power will create exploitative traps for the other party. the bargain becomes partly or fully predatory, and the pareto goal is purposefully not achieved, at least by one party. trebilcock summarized this potential when he wrote, “this presumption [that exchange will result in a pareto superior outcome] is rebuttable by reference to a fairly conventional list of forms 64 this list, while not complete, is a composite of factors drawn from a number of sources. see, e.g., robert cooter & thomas ulen, law and economics 341 (6th ed. 2012); trebilcock, supra note 6, passim; shavell, supra note 60, ch. 13-14. 2015 exposing the myth of consent 497 of market failure or, in a transaction specific context, contracting failure, which neo-classical economists recognize as inconsistent with this presumption, for example, monopoly, externalities, information failures.” 65 the failure to account for these disabling characteristics reflects a deliberate ignorance of reality for many kinds of markets and transaction realities. on the other hand, we believe that there are also many sorts of markets and kinds of transactions where the parties possess a sufficient allocation of “friedman” faculties. when parties possess such faculties, enforcement of the results of unconstrained bargains is sensible, and can be expected, on the whole, to lead to pareto enhancing results. many consumer retail transactions fall into this category. most people will indeed make good decisions on deciding what kind of toothbrush or laundry detergent to buy. even in these transactions, however, the distorting power of advertising gives the manufacturer some advantage in shaping the preferences of the consumer. 66 high dollar value deals between well-informed insiders in structured markets are likely to meet most of the criteria and to give the intended kind of results. examples of this range from the deals between film producers and the key service providers in a production, when all are experienced professionals, to transactions for commodities between a regular producer and an established company adding it to a product. in cases such as these, an un-recallable, fully reliable transfer or release is a critical ingredient in the ability to carry on the business-at-hand expeditiously. in these cases, the most radical version of unfettered consent has a place in a vibrant economy. but even here, the transactions are often, at least partly, structured in advance, through legal defaults, market rules, union minimums, industry expectations, standard forms, etc. even expert deals are generally not created on a “tabula rasa.” furthermore, the 65 trebilcock, supra note 6, at 7. 66 i can’t to i kant, supra note 10, at 729-30 (writing about the possible effects of “aspirational advertising” on youth). 498 indiana health law review vol. 12:2 potential for abuse exists here as well, as the sad tale of transactions such as the bankers trust’s “libor squared” contract of the 1990s demonstrates.67 of course, the real world is often far more “shadowy and lumpy” than the well-illuminated, un-tilted playing field of voluntary interchange imagined by friedman and others and embodied in the simple or expert transactions outlined above. even most neoclassical economists will concede this point, depending on how strongly one characterizes the term “often.” while the extreme view of unfettered autonomy to bind by consent may have a place in certain formal market contexts, cognitive limits and informational and power imbalances make a wide, unexamined application of this system inappropriate. new neuroscientific discoveries and behavioral studies change how we perceive “rational” actors. information relating to developing capacity, declining mental function, sundowning, situational stress, and other factors suggests that even “rational” actors may have trouble accessing knowledge, controlling impulses, and making the synaptic connections that result in optimal bargained-for outcomes. 68 in part, imperfect actors and conditions corrupt consent. welcome to the real world and the behavioral, neuro and heterodox economics that seek to describe what really happens. 69 relational contract theorists and others 67 see david m. rowe, risk management beyond var, 48 edpacs: edp audit, control, & security newsl., no. 1, 2013, at 1-27. one client, gibson greetings, sued bankers trust after its plain-vanilla swap agreements were replaced with a libor-squared variant. for a discussion of the gibson greetings case, see james overdahl & barry schachter, derivatives regulation and financial management: lessons from gibson greetings, fin. mgmt., spring 1995, at 24, 68-78. for legal background on the case, see david m. lynn, enforceability of over-thecounter financial derivatives, 50 bus. law., no. 1, nov. 1994, at 291337. see generally jonathan r. macey, death of corporate reputation: how integrity has been destroyed on wall street (2013). 68 see, e.g., “bee line,” supra note 1, at 66-78. 69 see, e.g., beyond neoclassical economics: heterodox approaches to economic theory (fred e. foldvary ed., 1996). 2015 exposing the myth of consent 499 recognize that imperfect conditions, compromised actors, deceptive or manipulative practices, incomplete information, and myriad other factors lead to inefficient results or bad deals by human (and, therefore, imperfect) actors.70 looking at the challenges, we conclude that the circumstances where pareto outshines predation are better regarded as a special case and not the general case for establishing the power of consent under the law. there is simply too much potential in too many circumstances for a failure of the criteria of a utility enhancing bargain to justify radical consent as the default choice. it is worth recalling that pareto is any “rational” player’s second best outcome, less desirable than one where the transaction deducts value from the other side and adds it to the “rational” player’s account. if the given player can arrange the transaction in such a predatory manner without other negative consequences (such as those that might accrue from social stigma, the law or repeat play concerns), there is all too great a temptation to go for option one to do just that. in such a predatory case, obviously, the pareto enhancing utility goals of adopting unfettered consent as a default principle will not be met. in fact, just the opposite is likely to be the result. to deal with this, the law has carved out a significant number of “exceptions” to the general presumptions of radical consent. these exceptions buffer, constrain, or supplement the process of consent and the attainment of a binding promise. rather than viewing these legal and regulatory interventions as a drag on pareto optimizing processes—as neoclassical economists are wont to do—in many cases we should regard them positively. they become pareto-enhancing cognitive prostheses, rebalancing the 70 see, e.g., ian r. macneil, relational contract theory: challenges and queries, 94 nw. u. l. rev. 877 (2000); ian r. macneil, values in contract: internal and external, 78 nw. u. l. rev. 340 (1983); ian r. macneil, contracts: adjustment of long-term economic relations under classical, neoclassical, and relational contract law, 72 nw. u. l. rev. 854 (1977). 500 indiana health law review vol. 12:2 inequalities of power and information, or otherwise shoring up the failing assumptions on which a pareto transaction needs to rest.71 we argue, therefore, that these “exceptions” should constitute the actual general case. viewed correctly, we believe, the welfare-enhancing goals of neoclassical economics will be best served by a view of consent based in the reality of human cognitive capacity rather than in a myth of omnipotent rationality and capacity. an acceptance that pareto-prostheses have a positive role to play in many instances prompts a balanced inquiry into how the law should treat consent.72 c. combining economic and philosophical justifications: a rawlsian exploration another tradition combines economic and philosophical justifications in a contractarian context: the approach to justice espoused by john rawls. 73 his method involves imagining the rules that would be freely agreed to in advance by parties in the fictional “original position.” a key element in rawls’s analysis is to suppose that human actors will be differently placed in reality with respect to wealth, power, education, information, and cognitive capacity. 74 note how this sounds like both the world we in fact live in and the world that creates problems for the abstracted, neoclassical welfare enhancing transaction. in order to set rules for such a reality that will be fair and just, the players are placed behind a “veil of ignorance,” where they know what the inequities will look like, but are ignorant of where they will fall as individuals in that spread of inequality. sitting in such an original position, the future players are 71 it is possible to regard the rules of property, which are generally recognized by even the most libertarian neoclassicist, as such an intervention. see, e.g., epstein, supra note 59. 72 peter j. richerson & robert boyd, not by genes alone: how culture transformed human evolution 240 (2005). 73 john rawls, a theory of justice (1971). 74 id. at 118 et seq.; see also, nicholas l. georgakopoulos, principles and methods of law and economics: basic tools for normative reasoning 26 (2005). 2015 exposing the myth of consent 501 asked to rationally decide on the rules they want to govern the play once they find themselves in the game. the future players must also choose rules that they themselves cannot waive in the play itself—a step that would defeat the whole exercise. the story of odysseus and the sirens is a useful (if mythical) example of such a binding pre-commitment. the sirens were creatures with magically captivating voices that used their singing to lure sailors toward them and onto hidden rocks that would sink their ships and drown them all. the course which odysseus and his band needed to sail would take them within the sirens’ range. following the advice of circe, odysseus had his crew put wax in their ears to make them deaf to the singing. wishing to hear the beautiful music himself, odysseus did not use the wax, but had himself tied securely to the mast of the ship. he extracted a promise from all his crewmembers not to untie him, no matter how hard he begged or pleaded. in something like the original position, he was creating a rule to protect himself from the mistakes of his will in the heat of the moment. and of course, once the song was in his ears, odysseus begged his crew to set him free—which would have led to their destruction. his crew tied him only tighter. he was protected from himself and they from him.75 the rawlsian approach is, of course, a thought experiment rather than a real undertaking. however, we believe that the construction of the kind of buffered legal pathways to pareto style transactions that we propose here are not only appealing, but also useful. when players do not know whether they will be expert credit card proprietors or non-expert consumers who exist a step away from subsistence, the rules they agree to on credit penalties and bankruptcy will probably involve contract and consent limits embedded in law. they will probably not elect to have rules designed for certain transactions that bind in every circumstance. and when players do not know 75 homer, the odyssey, book 12, (samuel butler trans.) (c. 800 b.c.e.), available at http://classics.mit.edu/homer/odyssey.12.xii.html. 502 indiana health law review vol. 12:2 whether they will be inexperienced and vulnerable adolescent women, their predatory bosses, or the owners of companies that should safeguard workplaces for young workers, those players will make different elections than if they knew in advance. the law of “consent” that limits the right of such young workers to seek damages from the company might look considerably different from that applied in cases like doe v. starbucks. while we have so far examined justifications for consent that focus on particular transactions, the law also needs to take into account other goals in fashioning its approach. complications to such a rule-making exercise arise from the need to let the young learn from experience, the old to keep making the decisions that are within their fraying capacities, and the rest of us to achieve a significant level of self-determination and autonomy in our lives. the “nanny state” has a bad reputation for a reason, and not every opportunity for a binding commitment has a siren song consequence. the “nanny state” is arguably the polar opposite of the “friedman” state, and just as flawed. so how to strike the balance? we have work to do. a system that allows the rich to extract from the poor in one-sided credit transactions and the experienced to predate on youth just learning to manage their sexuality fails from almost any perspective, utilitarian or moral. we need to do better. we must dismiss the myth of radical consent as the starting point for the enforcement of rules about commitment. techniques already present in the law and ones that we can propose as new approaches help us to fortify a system of compensation for the “market failures” that otherwise threaten to defeat pareto. d. the challenge of “autonomy” another source of confusion stems from the idea that radical ideas of capacity and consent are necessary correlates of principles of human autonomy. this presumption sets up a kind of logical trap, in which autonomy is an “all or nothing” property. in such a view, if one wants, for example, adolescents or young adults to have 2015 exposing the myth of consent 503 control of some aspects of their sexuality (e.g. use of birth control or choices over an abortion), one must conclude that they, therefore, have full and binding consensual authority over all aspects of sexuality (e.g. consent to sexual relations with a coercive and deceitful supervisor). such a perspective is needlessly simple-minded. analyzing with greater nuance, one understands that “autonomy” (i.e. the ability to make one’s own choices about life) is always contextual. there is no necessary connection between the legal validation of a young person’s decisions about some aspects of sexuality and her legal protection in other contexts. this contextual approach is particularly important as society seeks to create “learning spaces” within which youth can exercise sexual decision making with a reduced threat of predation. society’s establishment of “learner’s permits” and “junior licenses” for driving recognizes that adolescents do not have an on/off switch for competence behind the wheel. why expect it in other aspects of life? similarly, one can recognize the capacity of the elderly to make certain binding decisions in the moment, and still protect or buffer the decision making of seniors in other contexts. factors such as the import of a matter, time of day, access to advisors, opportunities to change the mind, and physical and mental health can make all the difference in the quality and integrity of a decision. all of us face circumstances in which we need a bit of help or protection in making important decisions. none of that is inconsistent with any but the most simple-minded and absolutist view of autonomy. this understanding of human limitations is not just a common sense observation. cognitive neuroscience is linking up with traditional psychology to provide us with detailed knowledge of decision-making processes in a wide variety of populations that allows jurists and others to take a more nuanced approach. 504 indiana health law review vol. 12:2 iv. the neuroscience and psychosocial studies of decision making by diverse populations and in a variety of contexts a wide variety of influences can affect decision making. science now confirms the effects of certain factors such as age, financial indebtedness, medical condition, and stress. for example, many jurists who advocate for children have used the neurobiological and psychosocial evidence of adolescent development to show how teen decision making is different from that of adults.76 scientists have explored decision making in other situations to show how context affects how people actually make choices, sometimes in ways congruent with the so-called rational actor model and in others divergent. an examination of some of these situations and the related scientific studies sheds light on how people experience altered mental processes and how those processes may influence their decisions. a. neuroscience of decision making neuroscience is that branch of biology that investigates the physical processes of thought and behavior. its fundamental premise is the belief that an understanding of these physical attributes of structure, electrical activity, and chemical interaction will contribute to an understanding of the cognitive outcomes they help to produce. 77 at its best, neuroscience engages in a conversation with the more traditional approaches of psychology, economics, and other social sciences to help confirm some existing knowledge, contradict other elements of received wisdom, and generally illuminate the kind of inquiry we are engaged in here. indeed, the field of neuroeconomics has come into being precisely to integrate these findings into the insights from other branches of 76 see, e.g., the neurobiology of decision-making, supra note 1, at 502. 77 e.g., oliver r. goodenough & micaela tucker, law and cognitive neuroscience, 6 ann. rev. l. soc. sci. 61 (2010). http://dx.doi.org/10.1146/annurev.lawsocsci.093008.131523 2015 exposing the myth of consent 505 economic studies—including those of the neoclassical school. as cambridge neuro-psychologist michelle baddeley expressed it: “[n]euroscientific evidence can help us to understanding the roles played by socio-psychological factors in economic decision-making and—developing ideas from psychology, evolutionary biology and neuroscience— neuroeconomists argue that understanding brain organisation and function can help us to understand economic and financial behaviour.”78 it is not within the scope of this article to summarize or critique the tools and methods of neuroscience. some aspects are broadly accepted as settled science; others are open to greater concern. taken together, however, neuroscientific findings provide significant evidence for a more nuanced model of cognitive capacity than that produced by the simple assumptions of neoclassical economics. as baddeley summarized in the abstract to one of her works: typically, modern economics has steered away from the analysis of sociological and psychological factors and has focused on narrow behavioural assumptions in which expectations are formed on the basis of mathematical algorithms. blending together ideas from the social and behavioural sciences, this paper argues that the behavioural approach adopted in most economic analysis, in its neglect of sociological and psychological forces and its simplistically dichotomous categorization of behaviour as either rational or not rational, is too narrow and stark. . . . in understanding the mechanisms affecting economic and financial decision-making, an interdisciplinary approach is needed which incorporates ideas from a range of disciplines 78 baddeley, supra note 9, at 286. 506 indiana health law review vol. 12:2 including sociology, economic psychology, evolutionary biology and neuroeconomics.79 other neuroscientific reviews of decision making suggest a similar need for nuance of the kind we argue for here.80 factors cited as increasing or diminishing the capacity to make “correct” decisions of the kind anticipated from a “rational” economic actor include the presence of stress,81 emotional arousal,82 and help, training, and experience.83 experience is not just a matter of abstracted knowledge. one widely considered model for certain kinds of decision making suggests that the brain undertakes “neural value computations” 84 comparing the outcomes of taking or refraining from a particular action. the formation of the value assessments which underlie such a comparison, however, have been modeled and observed as iterative processes, built from repeated experience with taking the choice in question.85 such findings support our conclusion that the model of radical consent does disservice to those without experience, such as adolescents in matters of sexuality and most of us in the face of rare and unfamiliar transactions, such as the purchase of automobiles or houses. disclosure, while useful, is not necessarily an antidote to 79 id. at 281. 80 see, e.g., nasir naqvi et al., the role of emotion in decision making: a cognitive neuroscience perspective, 15 current directions in psychol. sci. 260 (2006); michael l. platt & scott a. huettel, risky business: the neuroeconomics of decision making under uncertainty, 11 nature neuroscience 398 (2008); daeyeol lee, decision making: from neuroscience to psychiatry, 78 neuron 233 (2013); christian c. ruff & ernst fehr, the neurobiology of rewards and values in social decision making, 15 nature reviews neuroscience 549 (2014). 81 e.g., katrin starcke & matthias brand, decision making under stress: a selective review 36 neuroscience and biobehavioral reviews 1228 (2012). 82 e.g., nasir naqvi et al., supra note 80. 83 e.g., johannes schiebener et. al., supporting decisions under risk: explicit advice differentially affects people according to their working memory performance and executive functioning, neuroscience of decision making 9 (2013). 84 ruff & fehr, supra note 80, at 549. 85 e.g., id.; lee, supra note 80. http://dx.doi.org/10.1111/j.1467-8721.2006.00448.x http://dx.doi.org/10.1038/nn2062 http://dx.doi.org/10.1016/j.neuron.2013.04.008 http://dx.doi.org/10.1038/nrn3776 http://dx.doi.org/10.1016/j.neubiorev.2012.02.003 http://dx.doi.org/10.2478/ndm-2013-0002 2015 exposing the myth of consent 507 the knowledge that brains seemingly need to acquire through trial and error. as we have argued, law needs to create relatively safe opportunities in which to gain such experience—the “learner’s permit” approach has neurological validity. the remainder of part iv takes a closer look at the results from neuroscientific and psychosocial studies in four specific contexts of decision making: anger, organ donation during times of grieving, stress and the elderly, and consumer acceptance of ctas. while explicitly anecdotal, together they provide a useful sampling of the scientific inquiries that are forcing a reconsideration of the simplified psychology of neoclassical economics. b. anger and decision making criminal law has perhaps always recognized the role of emotions in decision making. the “heat of passion” is a legal phrase that describes the enraged mental state of one accused of a crime. in some criminal cases, emotional rage constitutes a defense to disprove a required mental state, mens rea, such as premeditation. it can, thereby, effectively reduce a charge from, for example, homicide to manslaughter. for the defense to be applicable, however, the perpetrator’s act, the actus reus, must have occurred immediately after the rage prompting event. so, for hundreds of years at least, the law has recognized the influence of anger on “rational” decision making (or the lack thereof). recent psychosocial studies explore the influence of emotion on decision-making behavior. one study explored anger and decision making regarding tortfeasors. 86 86 jennifer lerner et al., sober second thought: the effects of accountability, anger, and authoritarianism on attributions of responsibility, 24 personality & soc. psych. bull. 563-74 (1998), available at http://faculty.haas.berkeley.edu/tetlock/vita/philip%20tetlock/phil%20tet lock/1994-1998/1998%20sober%20second%20thought....pdf (last visited april 5, 2015). http://dx.doi.org/10.1177/0146167298246001 508 indiana health law review vol. 12:2 subjects in a lab viewed an anger-inducing video and then made decisions on unrelated fictional tort claims involving negligence and injury. subjects who viewed the angerinducing video, as predicted, made more punitive attributions about responsibility than did those subjects who viewed a neutral emotion prime.87 researchers found that these results changed when subjects knew that they would be held accountable and were asked to explain their decisions to experts whose views they did not know. when subjects knew they would be held accountable for their decisions in the tort cases, they were better at managing the effects of anger on their decisions. they still felt the anger but subjects judged the tortfeasors less harshly. interestingly, subjects who viewed the neutral prime also made less punitive attributions when they knew they would have to explain their decisions to an expert.88 the results of this study prompted the researchers to conclude, “the punitive carryover might represent a form of misattribution; people apparently do not recognize the true determinants of their judgments.”89 the scientists added, “[p]erhaps the most important implication for affect judgment research is that social/structural relationships moderate the otherwise recursive relationship between blame cognitions and anger.”90 if the knowledge of individual accountability can temper the effect of an anger response on judgments then law arguably has a role to play in the mediation of emotions on decision making generally. c. decision making about organ donation by grieving relatives like anger, grief is another emotion that people recognize has an effect on decision making. rational decision makers might disagree about the decision to donate 87 id. at 568, 570. 88 id. at 568. 89 id. at 570. 90 id. at 572. 2015 exposing the myth of consent 509 a deceased loved one’s organs. religious views, interest in the advancement of science, and other factors influence the decision. however, stress and grief also play a role in this decision-making process. in one study, researchers noted that some family members might opt for organ donation to relieve their pain and suffering. others sought to “buy time” with sustained life support. these individuals retained the hope for their loved one’s recovery or wanted more time to adjust to the death and to say goodbye. those who declined donation might have done so to protest the injustice of their loss. some declined donation in protest or as a refusal to accept the loss of their beloved.91 several factors contributed to affirmative decisions to donate. first, the will of the decedent to donate, sometimes expressed in legal declarations, made the decision easier for grieving loved ones.92 the decedent’s desire did not always control, however. when family members reached consensus, donation was more likely to occur. when family members disagreed, the members who opposed donation tended to prevail. one study’s researchers explained: reasons for nondonation included fear about the reaction of the family . . . and the wish to avoid conflict. . . . some family members regarded responsibility for the decision to donate as theirs alone . . . , whereas others declined donation as they were reluctant to assume total responsibility. . . . compounding family stressors such as multiple losses or communication conflicts also contributed to situations of nondonation . . . .93 91 wendy walker et al., factors influencing bereaved families’ decisions about organ donation: an integrative literature review, 35 west. j. nurs. res. 1339, 1348-49 (2013). 92 id. at 1346. 93 id. at 1349. http://dx.doi.org/10.1177/0193945913484987 510 indiana health law review vol. 12:2 these factors indicate that cooperation and consensus in favor of donation during this stressful period contribute to affirmative donation decisions. this study also suggests that fear and attitudes regarding roles influence choice. one should be cautious in extrapolating from a study focused on organ donation to understand stress in other situations, often not involving issues of life and death so directly. on the other hand, this study is consistent with findings in broader contexts that stress, grief, conflict, fear, and other similar factors influence human decision makers in ways that put the validity of immediate consent into question. the federal trade commission’s decision to target funeral industry practices for particular scrutiny and attention under its funeral industry practices revised rule confirms that decision making in the context of grief over loss of a loved one deserves special treatment.94 d. effects of stress on financial decision making in aging persons a 2013 report confirms that high financial debt leads to stress, depression, and other negative general health indicators.95 the related question that arises is whether stress might reciprocally affect financial decision making. a study published in 2014 examined the influence of stress on financial decision making in persons aged fifty and older. investigators hypothesized that even the stressor of an unfamiliar environment might affect such decisions. choices that interested investigators included “life-changing decisions about debt in the environment of a financial institution, under perceived time pressure, and making decisions about job-offers in the context of welfare 94 16 c.f.r. § 453 (2015); see also ftc, complying with the funeral rule (2012), https://www.ftc.gov/tips-advice/businesscenter/guidance/complying-funeral-rule. 95 elizabeth sweet et al., the high price of debt: household financial debt and its impact on mental and physical health, 91 soc. sci. & med. 94 (2013). http://dx.doi.org/10.1016/j.socscimed.2013.05.009 2015 exposing the myth of consent 511 centers.”96 investigators wondered whether stress “effects are substantial enough to merit a change in core models of economic decision-making and ultimately the design of major policy institutions such as welfare mechanisms and regulatory structures for financial marketing and bankruptcy resolution.”97 in a laboratory setting, subjects responded to two blocks of financial decision tasks. after the first block, researchers randomly divided subjects into three sets, including one control group. the second group received a series of increasingly difficult iq test questions administered to prompt cognitive stress. in the third group, each subject experienced an ice-cold footbath, designed to increase blood pressure and other sympathetic nervous system indicators. subjects then responded to the second block of financial decision tasks. the researchers found: [e]xposure to stress significantly increases the degree of discounting displayed by individuals, and leads to large reductions in the respondents’ willingness to learn about investment options before making their final decision. . . . [s]tress increases monthly discounting rates by about one third, and reduces the average effort made to learn about risky decisions by about 20 percent. . . . [s]tress [also] increases the degree of risk aversion—the observed differences in risk aversion were however not statistically significant.98 lab research confirms that stress does influence decisions and decision-making processes in ways that significantly 96 liam delaney et al., effects of stress on economic decisionmaking: evidence from laboratory experiments, the institute for the study of labor (iza) discussion paper no. 8060, mar. 2014, at 2, available at http://ftp.iza.org/dp8060.pdf. 97 id. 98 id. at 3. 512 indiana health law review vol. 12:2 affect the perception and comparison of the utility of options. stable, well-developed preferences are among the prerequisites of a voluntary, pareto optimizing choice. both cognitive and physiological stressors contribute to the decision task changes.99 other “evidence from lab-based experiments suggests that mood and emotional state can strongly affect individual [financial] decisions in the short run.”100 liam delaney and his team noted that, “the relative weighting of shortversus long-term benefits is critically affected by the physical and mental state of respondents, and strongly influenced by primary impulses such as hunger, thirst and sexual arousal.” 101 scientists also indicated, “[r]ecent work . . . suggests that poverty can impede cognitive function and the quality of decisions—the results presented in this study suggest that physical or cognitive stress could play an important role in this relationship.”102 from the delaney study, researchers proposed, “[m]any real-world financial decisions arguably involve stress at the point of decision and our results clearly suggest that this may lead to fewer exploratory and less future-oriented decisions with clearly negative potential for individual and societal welfare.” 103 ironically, the very importance of certain decisions may make them more cognitively challenging for the non-expert; buffers and enhancers might improve outcomes in these circumstances. 99 id. at 13-14. 100 id. at 4 (citing andreas knapp & margaret s. clark, some detrimental effects of negative mood on individuals’ ability to solve resource dilemmas, 17 personality & soc. psychol. bull. 678-88 (1991)). 101 id. 102 id. at 15 (citing anandi mani et al., poverty impedes cognitive function, 341 sci. 976-80 (2013)). 103 id. http://dx.doi.org/10.1177/0146167291176011 http://dx.doi.org/10.1126/science.1238041 2015 exposing the myth of consent 513 e. effects of consumer apathy and other factors regarding click through agreements another recent study focused on the ctas discussed above in this article.104 in this study, researchers initially examined why consumers routinely fail to read these contracts. 105 they came to several conclusions about consumer beliefs regarding ctas. first, consumers believe that “ctas are too long and that reading them would take too much time and effort.” second, people think that “ctas are offered on a take-it-or-leave-it basis such that consumers have no choice but to accept their terms.” third, nonreaders did not think that ctas were relevant or applied to them. finally, “a significant number of participants explained their lack of readership on the basis of simple apathy, which may also reflect the belief that ctas are irrelevant.”106 having determined many of the reasons why consumers choose not to read ctas, researchers next investigated if they could address these beliefs and prompt response changes. specifically, they tested whether a modified cta might change the default decision not to read or cause readers to spend longer at the task. by counteracting participants’ beliefs, researchers significantly increased their subjects’ willingness to read the agreements. results also indicated that, “participants spent significantly more time reading the cta . . . when it was presented in a manner that suggested it was short and skimmable, that it had different terms, that it was relevant, and that it could be modified.”107 this cta study was limited in that it examined the consent offered by contracting undergraduates in an “online” music website. however, when given the chance to 104 see supra part ii.c. 105 victoria c. plautt & robert p. bartlett, iii, blind consent? a social psychological investigation of non-readership of click-through agreements, 36 law & hum. behav. 293-311 (2012). 106 id. at 299. 107 id. at 305 (emphasis in original). http://dx.doi.org/10.1037/h0093969 514 indiana health law review vol. 12:2 modify these ctas, subjects read more of the contract and “often used the modification option to purchase a more desirable contract.”108 if experimenters can prompt college students to read a cta, one can imagine how law and sociopolitical policy changes might cure or moderate apathy and hopelessness in other contexts to change decisionmaking behavior. f. other studies involving decision making researchers have only begun to explore the variety of factors that can influence “rational actor” decision making. however, as noted, investigators have examined diverse populations and a variety of contexts. in one study of informed consent for clinical research, scientists found “that empathy and emotion are related to subjects’ decisional capacity and informed consent. higher cognitive empathic abilities and good emotion recognition were related to increased decisional capacity and higher refusal rates.”109 a number of studies focus on decision making by alcohol dependents and recreational or addictive drug users. one study of this set determined that alcohol-dependent individuals made comparatively disadvantageous choices on the iowa gambling task (igt)110 and risky choices on the 108 id. at 306. 109 alexander supady et al., how is informed consent related to emotions and empathy? an exploratory neuroethical investigation, 37 j. med. ethics 311-317, 316 (2011). 110 damien brevers et al., impaired decision-making under risk in individuals with alcohol dependence, 38 alcohol clinical & experimental res. 1924, 1924-1931 (2014). researchers described the igt: in the igt, participants sat in front of 4 decks of cards that were identical in appearance, except for their labels a, b, c, and d. they were told that the game involved a long series of pack selections and wagers and that the goal was to earn as much money as possible. participants were informed that each trial would consist of (i) a pack selection and (ii) the turning over of 1 card from the selected pack to reveal the yield. participants were informed that they were free to switch between http://dx.doi.org/10.1136/jme.2010.037937 http://dx.doi.org/10.1111/acer.12447 2015 exposing the myth of consent 515 cups and coin flipping tasks.111 scientists suggested that, “alcohol-dependent individuals may be more prone to taking high-risk choices because of their lowered capacity to decks at any time, and as often as desired. the net outcome of choosing from either decks a or b was a loss of 5 times the average per 10 cards (referred to as disadvantageous decks), and the net outcome of choosing from either decks c or d was a gain of 5 times the average per 10 cards (referred to as advantageous decks). the total number of trials was set at 100 card selections. the dependent measure for advantageous choice was the number of cards picked from the advantageous decks in each block of 20 cards. id. at 1926. 111 the authors described the coin flipping task: participants decided whether to accept or reject mixed gambles that offered a 50/50 chance of either gaining a given amount of money or losing another amount. to encourage participants to reflect on the subjective attractiveness of each gamble rather than to rely on a fixed decision rule, we asked them to indicate 1 of 4 responses to each gamble (strongly accept, weakly accept, weakly reject, and strongly reject). the size of the potential gain and loss was manipulated independently, with gains ranging from €10 to €40 (in increments of €2) and losses ranging from €5 to €20 (in increments of €1), resulting in 256 random trials. the dependent measure of the coin flipping task was the participant’s gamble acceptance for 6 computed win/loss ratio that include trials in which (i) potential gain equal the potential loss, trials where potential gain was maximum (ii) twice, (iii) twice point 5, (iv) thrice, (v) 4 times, or (vi) 8 times the amount of the potential loss.”) id. in a lengthy discussion of the cups task, researchers explained: on each trial, an array of 2, 3, or 5 cups is shown on 1 side of the screen, with the possible gain or loss shown on top. this array is identified as the risky side where selection of 1 cup of the total number of cups will lead to a designated number of euros gained (or lost), whereas a selection of the other cups will lead to no gain (or no loss). after participants made the choice, the gamble was resolved immediately, allowing them to experience the consequence of the risky or safe choice. id. 516 indiana health law review vol. 12:2 manage the interference effects induced by immediate, highly salient information in working memory.”112 their findings demonstrated that results on the igt did not recover over time after abstinence from alcohol consumption.113 other similar decision-making studies include research involving at-risk 114 and pathological 115 gamblers, heroin dependents, 116 and recreational and dependent cocaine users.117 this research on the decision making of substance users and dependents leads to questions about how diet, exercise, and other activities might affect decision-making processes. one study concerning an activity’s influence on decision making found that mindfulness meditation 112 id. at 1929. 113 id. at 1924. 114 jon edgar grant et al., selective decision-making deficits in atrisk gamblers, 189 psychiatry res. 115-120 (2011) (suggesting that selective cognitive dysfunction may be present for decision making by at-risk gamblers, even before psychopathology arises). 115 anja kräplin et al., dysfunctional decision-making in pathological gambling: pattern specificity and the role of impulsivity, 215 psychiatry res. 675–682 (2014) (“pgs [pathological gamblers] exhibited higher risk seeking and an immediate reward focus in the cgt [cambridge gambling task] and, in contrast, comparable strategic planning to the control group. . . . decision-making impairments were related to more severe delay discounting and, specifically, to increased urgency and less premeditation.”); wan-sen yan et al., working memory and affective decision-making in addiction: a neurocognitive comparison between heroin addicts, pathological gamblers and healthy controls, 134 drug and alcohol dependence 194-200 (2014) (“our findings indicate that deficits in affective decision-making shared by heroin dependence and pg putatively represent vulnerabilities to addiction and that working memory deficits detected only in heroin addicts may be identified as heroin-specific harmful effects.”). 116 yan, supra note 115, at 194-200. 117 l. m. hulka et al., altered social and non-social decisionmaking in recreational and dependent cocaine users, 44 psychol. med. 1015–1028 (2014) (finding, in part, that decisions in the social interaction tasks of both cocaine user groups were more self-serving compared with controls given that cocaine users chose higher monetary payoffs for themselves). researchers observed that only dependent cocaine users made riskier choices on the igt. id. at 1024. http://dx.doi.org/10.1016/j.psychres.2011.05.034 http://dx.doi.org/10.1016/j.psychres.2013.12.041 http://dx.doi.org/10.1016/j.drugalcdep.2013.09.027 http://dx.doi.org/10.1017/s0033291713001839 2015 exposing the myth of consent 517 correlated with a reduction of the “sunk cost bias.”118 more specifically, participants who regularly meditated were better able to resist the impulse to continue an endeavor once they had already invested (money, time, or effort) in the task.119 another area of research involves examination of the particular decision-making capacities of elders. one study examined the diurnal cycle of cortisol that researchers believe “to be an indicator of one of the main stress-response systems, the hypothalamic-pituitary-adrenal (hpa) axis.”120 this area of research suggested that chronic stress may accelerate cognitive decline in older adults. g. the person or the situation: which comes first in the corruption of consent? these studies highlight the question of whether context or the actor may influence or corrupt consent. margaret isabel hall discusses the difference between incapacity and impaired consent. she explains, “distinguished from incapacity, equity explains impaired consent with reference to the situation or context, rather than the internally generated and fixed state of the individual (the individual is incapable; the situation is one of undue influence or the transaction is unconscionable).”121 she acknowledges that individual characteristics, including “declining or fluctuating mental processes of early dementia” are relevant 118 andrew c. hafenbrack et al., debiasing the mind through meditation, psychol. sci. 1-8 (2013). 119 id. at 6-7. researchers defined mindfulness meditation as consisting “of focusing on present experience and clearing one’s mind of other thoughts; this is often accomplished by focusing attention on the physical sensations of breathing.” id. at 1. 120 joshua a. weller et al., diurnal cortisol rhythm is associated with increased risky decision-making in older adults, 29 psychol. and aging 271, 272 (2014). 121 margaret i. hall, capacity, vulnerability, risk, and consent: personhood and the law, in decision-making, personhood and dementia (deborah o’connor ed., 2009). http://dx.doi.org/10.1177/0956797613503853 http://dx.doi.org/10.1037/a0036623 518 indiana health law review vol. 12:2 to impaired consent but that “[n]one of these factors are, in themselves, sufficient to establish incapacity.”122 we are agnostic on the point of establishing a legal threshold of incapacity, especially as it pertains to future decision-making autonomy. however, we make two related points. first, certain situations can clearly influence human mental and physiological responses that prompt “consent.” second, the legal result of incapacity and impaired consent are the same: voidability of consent (or a contract). if jurists cannot know whether the stressful situation or the individual’s biochemical-psychological response corrupts capacity does it really matter? evidence concerning individual incapacity and situational forces demonstrates that “radical consent” should not remain the default presumption. v. addressing the myth of consent with traditional and neurojuridical tools we have argued so far that the model of “radical consent,” which prominent legal economists use for establishing rights and obligations under private law, is poorly matched to the task of creating just and optimal results in many cases. we have also advocated for legal rules that create more nuanced frameworks for transactions and other consent-driven interactions. we have explored the contributions that cognitive neuroscience and related areas of psychology can make to help us understand the kinds of problems humans face when giving legally binding consent. here we turn to the kinds of traditional and innovative neurojuridical tools that implement more nuanced strategies in the law. for the young, we can seek training grounds for pareto style optimization. for the elderly, we can design increasing levels of protection that do not depend upon the “on-off switch” of traditional determinations of “capacity.” and for the rest of us, we can fashion domain-specific protections that provide “pareto prostheses” to aid contextually challenged actors in making 122 id. 2015 exposing the myth of consent 519 good choices in a potentially predatory world.123 happily, we are not starting from scratch; jurists have already created and incorporated a significant number of such legal protections. a. historical legal approaches to the myth of consent for hundreds of years, the law has recognized that some persons who benefit from autonomous action may not have the capacity to make sound legal decisions consistently. the law has historically accounted for the myth of legal consent by these persons. it has recognized that their capacity could be developing or compromised. one can find legal catalysts that have operated for hundreds of years to address vulnerable actors. 1. historical approaches to cognitive incapacity two restatements of law have long distinguished legal capacity and consent by minors and others. for example, these restatements implement legal catalysts to facilitate “consent” by minors, while at the same time protecting them from their bad or compromised decisions. according to the second restatement of contracts, section 12 (2), “a natural person who manifests assent to a transaction has full legal capacity to incur contractual duties thereby . . . .”124 this section expresses the legal default. however, it also lists four exceptions, including infants 125 and the mentally ill or defective, 126 who lack the capacity to consent.127 123 see generally oliver r. goodenough, governance for cloud computing: the role of public and private rulemaking in promoting the growth of a new industry, (vermont law school research paper no. 34-13, 2013), available at http://ssrn.com/abstract=2342594 or http://dx.doi.org/10.2139/ssrn.2342594. 124 restatement (second) of contracts § 12(2) (1981). 125 id. § 12(2)(b) (1981). 126 id. § 12(2)(c) (1981). 127 see id. § 12(2)(b) (1981). http://dx.doi.org/10.2139/ssrn.2342594 520 indiana health law review vol. 12:2 minors and those lacking capacity can still make contracts but they are voidable by the minor or the one with the disability. 128 we allow minors and other vulnerable persons to void their contracts because we fear that unscrupulous adults will take legal advantage of children 129 and the disabled. 130 the rescission right operates as a legal catalyst. it protects minors and the disabled from poor contract choices since these persons (or their guardians) can extract themselves from disadvantageous deals. it also serves as notice to their adult contract partners that they do business with minors or the disabled at their risk. the law does not, however, ban contracting between adults and such vulnerable persons. minors, elders, and the disabled enjoy the freedom to exercise their autonomous choices and bargain while still protected by the safety net of rescission. the second restatement of torts, section 892a, similarly addresses capacity and consent. 131 subsection (2)(a) provides that in order to extinguish tort liability, for example, consent must be “by one who has the capacity to consent.” a comment to this subsection provides: 128 see, e.g., cal. family code § 6710 (west 2014) (allowing minors to disaffirm contracts during their minority or within a reasonable time afterwards); jones v. dressel, 623 p.2d 370, 373 (colo. 1981); jeff ferriell, understanding contracts 603-04 (2d ed. 2010); see also restatement (second) of contracts § 14 (1981). 129 “it is the policy of the law to protect infants against their own mistakes or improvidence, and from designs of others, and to discourage adults from contracting with an infant.” ex parte odem, 537 so. 2d 919, 920 (ala. 1988) (quoting 43 c.j.s. infants § 180 (1978)). some states require that a minor return consideration or benefits received. see, e.g., mullen v. tucker, 510 n.e.2d 711 (ind. ct. app. 1987) (finding that return of consideration was required to void the contract but that failure to do so was not a condition precedent to power to avoid). 130 knowlton v. mudd, 775 p.2d 154, 156 (idaho ct. app. 1989) (allowing conservator of a woman who suffered from parkinson’s disease to void a contract amendment because the woman lacked sufficient mental capacity to understand the amendment). 131 restatement (second) of torts § 892a(2)(a) (1979). 2015 exposing the myth of consent 521 if, however, the one who consents is not capable of appreciating the nature, extent or probable consequences of the conduct, the consent is not effective to bar liability unless the parent, guardian, or other person empowered to consent for the incompetent has given consent, in which case the consent of the authorized person will be effective even though the incompetent does not consent . . . .132 this explanatory comment contemplates that children, for example, may not have capacity. it also stresses the cognitive aspects of capacity. the law provides that parents or other empowered persons can consent for the one lacking competence. how one judges whether the minor is capable remains unexplored and highlights the problematic nature of consent by minors in tort law. what this brief consideration of consent by minors and the disabled makes clear is that the law functions to allow autonomous choice by vulnerable persons. arguably, these persons who lack capacity are not truly consenting, hence the myth of legal consent. we permit them to void their consent, however, to minimize the negative consequences of consent that disadvantages them. we can now see how historical approaches to the myth of consent might assist vulnerable actors introduced above. if we permitted jane doe to withdraw her consent to sex, rescind her agreement, she might still sue for sexual harassment or other tort injuries. horton should have been on notice that any agreement struck with doe was voidable by doe. starbucks would have made clear to its agents and supervisory employees that it would not tolerate “consensual” sexual liaisons at work. while the use of the restatement might not protect doe in the first instance, it does offer her some relief for her mistaken bargain. similarly, mrs. belinky can consent to overnights by her husband. however, he proceeds with the understanding 132 id. § 892a cmt. b (emphasis added). 522 indiana health law review vol. 12:2 that she can rescind her consent. what protects the drake center? it can request indemnification by mr. belinky. 2. historical approaches to volitional incapacity some of the parties introduced above suffered not from cognitive impairment but from trouble making choices because of situational stress or a temporary inability to control their behavior. the second restatement of contracts distinguishes between cognitive and volitional incapacity in the context of mental disabilities. section 15(1) provides: a person incurs only voidable contractual duties by entering into a transaction if by reason of mental illness or defect (a) he is unable to understand in a reasonable manner the nature and consequences of the transaction, or (b) he is unable to act in a reasonable manner in relation to the transaction and the other party has reason to know of his condition.133 mirroring the tort guidance of section 892a, subsection (a) focuses on cognitive capacity. subsection (b) concerns volitional incapacity, the inability to regulate one’s responses in a social context. this second subsection anticipates that, even though some actors may understand the nature of a transaction or conduct, these incapacitated individuals may not be able to control their responsive behavior reasonably. comment b. to section 15 notes that various types of mental incompetency exist in varying degrees. it lists several disabilities including “congenital deficiencies in intelligence, the mental deterioration of old age, the effects of brain damage caused by accident or organic disease, and mental illnesses evidenced by such symptoms as delusions, 133 restatement (second) of contracts § 15(1) (1981). 2015 exposing the myth of consent 523 hallucinations, delirium, confusion and depression.”134 in further illustrating volitional incapacity, the comment explains: even though understanding is complete, [an incapacitated man] may lack the ability to control his acts in the way that [a] normal individual can and does control them; in such cases the inability makes the contract voidable only if the other party has reason to know of his condition. where a person has some understanding of a particular transaction which is affected by mental illness or defect, the controlling consideration is whether the transaction in its result is one which a reasonably competent person might have made.135 this passage contemplates that when a transaction partner has reason to know of volitional incapacity, the contract will be voidable. again, a legal tool, rescission, protects individuals who suffer from volitional incapacity. if the partner has reason to know of the disabled condition, he is on notice that he proceeds with the action at his risk. most actors know when they are dealing with elders or disabled individuals. many can ascertain this information by requesting age specifying identification or by the nature of the circumstances. mr. belinky knew that his wife was disabled and was willing to take the risk of accusation just to comfort her. this comment also prompts the question whether some mature and otherwise fully functional adults may suffer from a similar volitional incapacity or “defect.” what about a mourner at a funeral home, a residential consumer buying a vacuum cleaner from a door-to-door salesman, or a 134 restatement (second) of contracts § 15 cmt. b (emphasis added). 135 id. (emphasis added). 524 indiana health law review vol. 12:2 mortgagee who is about to sign loan documents? as discussed below, the law already anticipates all of these cases. this very brief review of capacity and consent highlights that the law (of at least two restatements) anticipates many circumstances in which actors may have developing, diminished, or declining capacity. however, with every mature adult, we assume full legal capacity by default. neuroscientific discoveries relating to developing capacity, declining mental function, sundowning, and situational stress suggest that even rational actors may have trouble accessing knowledge, controlling impulses, and making the synaptic connections that result in optimal bargained-for outcomes. in part, imperfect actors and conditions corrupt consent. the neuroscience and psychosocial evidence not only bolster historical attempts to deal with human frailties, they also highlight the need for more comprehensive legal responses. the necessary steps to reform are as much conceptual as creative: we need to move from viewing these approaches as exceptions to viewing them as readily available elements in the law’s bag of tools. in section b., we proceed with a summary review of a number of the existing tools, not so much to create an exhaustive catalog but to flesh out our argument and prompt further discussion. in section c., we suggest a possible re-framing of consent that may form the basis for a more fundamental change in approach, particularly in the context of a learning period such as adolescence. b. traditional tools the existing tools can, for the most part, be grouped into two large categories: (1) consent “enhancers” and (2) consent “frames” or “buffers.” the enhancers generally aim to balance the information and cognitive capacities of the players. 1. consent enhancers 2015 exposing the myth of consent 525 many professionals strive to inform the more ignorant. disclosure rules operate in many contexts, from cigarette sales136 and drug and medical therapies137 to offerings of investment securities.138 many people question the efficacy of disclosure, at least as it frequently plays out in real world practice. dense legalese, repelling typeface, and other barriers thwart actual engagement and understanding. these hindrances underscore the potential payoffs for transaction players who can induce evaluation failure in their contracting counterparts.139 education about the meaning of information is a related goal. an information processing imbalance can be as damaging for a party as an information access imbalance. enhanced training of players to better evaluate available information might ameliorate processing imbalances. given the possibility for self-protection that educated consumers can muster for themselves, the american educational system’s failure to emphasize financial literacy and related skills is surprising. in a sense, the best way to educate is to create a safe space in which to experiment with decision making for a particular task. we seek to foster this 136 21 c.f.r. §§ 1141.10(a), 1141.12 (2015); see also overview: cigarette health warnings, fda, archived at http://perma.cc/y7haxkgb. see generally andrew c. budzinski, a disclosure-focused approach to compelled commercial speech, 112 mich. l. rev. 1305 (2014). 137 e.g., david g. adams, fda regulation of communications on pharmaceutical products, 24 seton hall l. rev. 1399 (1994). 138 15 u.s.c. §§ 77f, 77g (2014) 139 omri ben-shahar & carl e. schneider, more than you wanted to know: the failure of mandated disclosure (2014); omri ben-shahar & carl e. schneider, the failure of mandated disclosure, 159 u. pa. l. rev. 647 (2011); yannis bakos et al., does anyone read the fine print? consumer attention to standard-form contracts, 43 j. legal stud. 1 (2014); florencia marotta-wurgler, will increased disclosure help? evaluating the recommendations of the ali’s “principles of the law of software contracts,” 78 u. chi. l. rev. 165 (2011); are 'pay now, terms later' contracts worse for buyers? evidence from software license agreements, 38 j. legal stud. 309 (2009); florencia marotta-wurgler, competition and the quality of standard form contracts: the case of software license agreements, 5 j. empirical legal stud. 447 (2008). http://dx.doi.org/10.1086/674424 http://dx.doi.org/10.1086/596040 http://dx.doi.org/10.1111/j.1740-1461.2008.00130.x 526 indiana health law review vol. 12:2 approach in suggesting legal assent, described below. as discussed above, neuroscience studies indicate that simple access to information is no replacement for experience that exercises the cognitive neurobiological tools for effective decision making. “once burned, twice shy” says the proverb, not “once warned, twice shy.” experience builds judgment in a way that neutral information cannot. the provision for or even mandated expert advice is another technique that can help bridge this information gap. the u.s. securities and exchange commission (sec) regulation d adopts this approach in the rule 506 requirement for the participation of a purchaser representative for unsophisticated, non-accredited investors.140 these enhancement techniques and others are intended to move otherwise disadvantaged participants closer to the cognitive and informational ideal on which the benefits of consent are premised. as with many well-intentioned measures, such “fixes” can sometimes have unintended consequences that can make them counterproductive. the cigarette industry, for instance, has been able to successfully assert that the highly visible warnings about the dangers of smoking make the “choice” of smoking a matter of autonomy by the smoker, fending off potential liability for the manufacturer that sells an inherently damaging product.141 2. consent buffers and frames the second major set of responses uses embedded “frames” and “buffers” in the law of obligation and consent itself. one approach involves creating un-waivable (or at least hard to waive) duties on the other party to avoid taking advantage in a context of consent. fiduciary duties are a classic example of this. a trustee is obligated not to engage in predatory practices with the beneficiary of the 140 17 cfr § 230.506(b)(2)(ii) (2014). 141 jack e. henningfield et al., tobacco industry litigation position on addiction: continued dependence on past views, 15 tobacco control iv27 (2006), archived at http://perma.cc/k8kt-9r9e. 2015 exposing the myth of consent 527 trust, or with its corpus. the consent by the beneficiary to any “self-dealing” transaction is hedged around with hardto-satisfy requirements for disclosure and for objective fairness. 142 the law of corporations adopts similar requirements for directors and officers. under classic law, a self-dealing transaction was presumptively void. even under “reformed” practice it remains voidable unless specified standards of disclosure, deliberation, and substantive fairness are met.143 in contract and property law, implied warranties of merchantability, fitness for habitation, and marketable title create duties that buffer against bad decision making and predatory activity.144 other tools for providing contextual granularity to problems of capacity and consent involve rebuttable presumptions, that both protect and provide some flexibility, suitability standards, such as those embodied in sec regulation d for accredited investors,145 and waiting periods and rescission rights, as in real estate mortgages in many states.146 fraud laws provide a general protection against active misrepresentation as a predatory practice. the ftc is a particularly prolific source of traditional “exception” style rules. their regulations create consumer protections in contexts of stress, imbalance of experience, and coercive pressure of the kind we have identified as good candidates for a pareto prosthesis. for example, ftc regulations address cooling off periods for sales made in homes or at other specific locations.147 similarly, another 142 austin w. scott, the fiduciary principle, 37 calif. l. rev. 539 (1949); charles bryan baron, self-dealing trustees and the exoneration clause: can trustees ever profit from transactions involving trust property, 72 st. john’s l. rev. 43 (1998). 143 model bus. corp. act §§ 8.60-8.63 (2008); del. code ann. tit. 8 §144(a)(1)-(3) (2014). 144 hilder v. st. peter, 478 a.2d 202 (vt. 1984); lohmeyer v. bower, 227 p.2d 102 (kan. 1951); u.c.c., §§ 2-315, 2-316 (2013); hogg, supra note 47; wallace sedgwick et al., products liability: implied warranties, 48 marq. l. rev. 139 (1964). 145 17 cfr § 230.501(a) (2014). 146 12 cfr § 226.19 (2014). 147 see, e.g., 16 c.f.r. § 429 (2014). http://dx.doi.org/10.2307/3477686 528 indiana health law review vol. 12:2 ftc regulation addresses deceptive credit practices. 148 another ftc provision deals with funeral home practices and requires disclosures for specific services and prior approval for certain procedures.149 other sections deal with deceptive advertising and labeling of cigarettes,150 used car sales, 151 telephone and mail order sales, 152 and home insulation.153 home insulation is a classic example of an unusual transaction where the consumer has little experience and where the end result will be hard for the consumer to evaluate.154 these regulations clearly anticipate the distorting effects of physiological disabilities (nicotine addiction), stressful sales conditions, and other compromising circumstances. they also foresee the possibility of predation by savvy operators who attempt to exploit grieving, stressed, or otherwise compromised individuals. while we applaud most of these rules, we view them as still being part of a pattern of piecemeal response to context-specific concerns. we think it is time for society and its jurists to modify legal defaults more generally to account for the realities of human decision making. and in doing so, they should take advantage of the contributions that neuroscience can make to policy determination and implementation. the following discussion explores how we might develop a cognitively informed set of tools, moving through and beyond traditional approaches to the myth of consent. c. a new neurojuridical tool—legal assent the law has historically addressed both cognitive and volitional incapacity through rescission. it has also dealt 148 16 c.f.r. § 444 (2014). 149 16 c.f.r. § 453 (2014). 150 16 c.f.r. § 408 (2014). 151 16 c.f.r. § 455 (2014). 152 16 c.f.r. § 435 (2014). 153 16 c.f.r. § 460 (2014). 154 for a general treatment of ftc rules in consumer protection areas, see selected industries, ftc, archived at http://perma.cc/5z45xb6y. 2015 exposing the myth of consent 529 with bargaining imbalances through traditional consent enhancers and buffers. one can envision other catalytic tools, however, to promote efficient bargains and protect vulnerable actors. for example, legal assent offers a new mechanism to advance a bargain through to commitment while still protecting the assenting party. it contests the default approach that assumes highly sophisticated and competently cool, rational actors. legal assent carries no presumption of capacity. society credits assent with legal relevance because it wants to afford frail, immature, and mentally or emotionally disabled persons the independence, autonomy, and opportunity to practice good decision making. legal assent operates as a “temporary permit” for legal authority. legal assent might work for many classes of compromised persons: adolescents, frail elders, grieving persons, and the mentally challenged. as opposed to medical assent, legal assent when offered by an adolescent, for example, does not require associated parental permission or consent. similar to consent by a minor under contract law, assent is voidable by the minor. assent operates slightly differently from traditional, voidable contract consent by a minor, however. as noted, assent presumes no legal capacity. moreover, the minor or assenting party may void assent only with good reason. adult abuse, adult exploitation of an unfair advantage, and breach of a duty owed to the minor or to another assenting person, all justify revocation. additionally, parents cannot void a minor’s assent. although parents may offer their wise guidance, undue influence by a parent or other adult nullifies revocation. if a court determines that the original decision was, borrowing from family law, in the minor’s or the assenting party’s best interests, it can reject the revocation.155 on the other hand, if a minor or assenting party successfully voids her assent, a court cannot admit it into evidence or permit discovery on the matter. a criminal 155 see troxel v. granville, 530 u.s. 57, 69 (2000) (explaining the “presumption that a fit parent will act in the best interest of his or her child”) (citing parham v. j.r., 442 u.s. 584, 602 (1979)). 530 indiana health law review vol. 12:2 prosecutor might still prosecute an adult who has sex with an assenting minor, however, because the assent operates solely to benefit the minor or the assenting party. one can see how assent might change the outcome of several cases discussed above. jane doe could revoke her assent to sex with her starbucks manager. presumably, sex with the manager was not in her best interest. an elderly person who assents to pay for a new roof offered by an unscrupulous door-to-door salesperson may revoke his assent. a grieving person might revoke assent offered for funeral services not needed, beyond the financial wherewithal of the assenter, and extracted in suspicious circumstances. the world of commerce will not come to a screeching halt with the implementation of legal assent. honest adults will not have sex with minors or try to sell unneeded services to the elderly and grieving family members. judges will not permit the abrogation of decisions wisely made in the first instance. the voidability of corporate action in the presence of director self-interest noted above provides a point of comparison for this approach. legal assent operates to allow the assenting party only to correct an error made in the moment of immature, disoriented, or stressed decision making by a compromised individual. it plays a role in a controversy only when the bargaining party with the superior position contests the withdrawal of assent. it evens the playing field. vi. conclusions “mistakes are the usual bridge between inexperience and wisdom.” phyllis theroux, night lights the neoclassical model of radical consent has value for many everyday purchases as well as for sophisticated transactions by savvy, knowledgeable traders and market professionals. however, radical legal consent disadvantages many more common individuals, particularly in unfamiliar or stressful circumstances, and should not serve as the 2015 exposing the myth of consent 531 default legal presumption for most transactional encounters. we all make mistakes. as responsible adult actors, we must suffer the consequences of many of them. however, the law can and already does anticipate when legally binding consent is tainted by immaturity, dementia, or some other biophysical, mental, or emotional disability. this article demonstrates that neuroscience and psychosocial studies provide the supportive evidence for dismantling the radical default of un-buffered legal consent. it begins the conversation about how a reconceptualization of legal consent might benefit from the use of neurojuridical tools. enhancers, frames, and new mechanisms, such as legal assent, work to even playing fields and optimize mutually beneficial transactions. pareto prostheses have existed for hundreds of years in law. we should give them full recognition for the valuable service they do for so many individuals. as youth develop wisdom, as elders and others adjust to their changing capacities, the law can facilitate autonomous or semi-independent participation in commerce and legal transactions. legal capacity is not an on-off switch. it is time to recognize that reality and find new ways to illuminate the field lights for more pareto-seeking legal players. 1. introduction a. legal defaults can be useful but need to complement reality b. goals of this article ii. application of the radical neoclassical approach to consent can lead to injustice, ambiguity, and predation a. consent by teenagers or sexual exploitation? 1. doe v. starbucks, inc. 2. the radical neoclassical approach to “consenting” teenagers b. capacity and consent by elders and disabled persons c. “click-through” consent by software users d. the class list goes on and on iii. justifications and critiques of the radical neoclassical vision of consent a. morality and philosophy b. economic justifications c. combining economic and philosophical justifications: a rawlsian exploration d. the challenge of “autonomy” iv. the neuroscience and psychosocial studies of decision making by diverse populations and in a variety of contexts a. neuroscience of decision making b. anger and decision making c. decision making about organ donation by grieving relatives d. effects of stress on financial decision making in aging persons e. effects of consumer apathy and other factors regarding click through agreements f. other studies involving decision making g. the person or the situation: which comes first in the corruption of consent? v. addressing the myth of consent with traditional and neurojuridical tools a. historical legal approaches to the myth of consent 1. historical approaches to cognitive incapacity 2. historical approaches to volitional incapacity b. traditional tools 1. consent enhancers 2. consent buffers and frames c. a new neurojuridical tool—legal assent vi. conclusions where do treating physicians belong as witnesses in the seventh circuit? courtney e. campbell* i. introduction ...................................................................................... 247 ii. background ...................................................................................... 249 a. case law prior to the 1993 rule 26 amendments ................. 249 b. the 1993 amendments to rule 26(a) ...................................... 250 c. survey of cases in united states federal courts ................... 251 1. failure to disclose may not preclude treating physician from testifying ......................................................................... 252 2. after designation as an expert, should a report be produced? ................................................................................ 253 a. expert report required only when testifying to causation, prognosis, and/or future disability ...................................... 254 b. depends on the extent of the treating physician's testimony .............................................................................. 255 d. seventh circuit's management of treating physicians .......... 26l 1. being retained creates a report requirement .................. 264 2. causation creates a report requirement ........................... 264 3. disclosure depends on how the information was obtained ................................................................................... 266 e. lingering problems ................................................................ 269 iv. suggestedframework .................................................................. 274 a. taking into account the purposes of treating physicians' testimony ..................................................................................... 274 b. balancing test proposition .................................... ; ................ 216 c. when treating physicians are designated experts needing to produce a summary report, what should be included? ......... 277 v. conclusion ........................................................................................ 279 i. introduction within the scope ofrule 26 ofthe federal rules of civil procedure, it has been difficult to determine a role for the treating physician as a witness. the "[amended federal] rules of discovery and evidence have camouflaged the treating physician. the time has come to explore the forest of precedent *j.d. candidate, 2012, indiana university school of law-indianapolis; b.a., 2006, uni­ versity of notre dame. 248 indiana health law review [vol. 9:1 in search of that chameleon."1 whether a physician should be treated as a fact witness or an expert witness in federal courts has been a matter of de­ bate for some time because of their dual roles as both types of witnesses.2 as fact witnesses, treating physicians testify as ''first-hand participants in the diagnosis and treatment of the plaintiff," yet "diagnosis and treatment are almost certainly informed by the physician's specialized training and knowledge."3 in other words, treating doctors are first-hand observers of what has occurred to their patients, but may also be seen as scientific ex­ perts when speaking to complex medical issues.4 before the 1993 amendments to federal rule of civil procedure 26(a), a doctor needed to be disclosed as an expert only when he was testi­ fying as to causation or speaking beyond the scope of his or her treatment of a patient. s whether a witness was an expert depended on the "not status of the witness, but rather on the substance of the testimony.'.6 in addition, experts were not required to produce an expert report. 7 however, the 1993 amendments to rule 26 and subsequent case law changed this process by requiring those who are retained in anticipation of litigation to provide an expert report. 8 rule 26 was amended again in de­ cember 2010 to require a summary report from even those witnesses who are not retained in anticipation of litigation.9 as a result of these developments, the time. is ripe to definitively de­ cide how treating physicians should be categorized in the seventh circuit. this note will generally discuss whether a physician should be treated as a 1. dorothea beane & theodore e. karatinos, catching the chameleon: when is the treating physician an expert?, fed. law., may 2004, at 26. 2. eric s. dreiband, recent developments in disabilities discrimination and litiga­ tion: use of expert witnesses, in employmbnti>iscrimination law and litigation 2010, 291, 295 (pu utig. & admin. practice, course handbook ser. order no. 23389, 2010). 3. id 4. the federal rules of evidence draw a line between expert testimony and fact testimony. fed. r. evid. 701 qualifies lay witness fact testimony as, "limited to those opin­ ions or inferences which are (a) rationally based on the perception of the witness, (b) helpful to a clear understanding of the witness' testimony or the determination of a fact in issue, and (c) not based on scientific, technical. or other specialized knowledge within the scope of rule 702." alternatively, fed. r. evid. 702 describes testimony by experts as when "scien­ tific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue," and such a witness is "qualified as an expert by knowledge, skill, experience, training, or education." 5. fed. r. cn. p. 26 advisory committee's note (1970). see, e.g., canterbury v. spence, 464 f.2d 772, 791-92 (d.c. cir. 1972) ("experts are ordinarily indispensible to identify and elucidate for the ~der the risks of therapy and the co~equences ofleaving existing maladies untreated. they are normally needed on issues as to the cause of any inju~ ry or disability suffered by the patient and, where privileges are asserted, as to the existence of any emergency claimed and the nature and seriousness of any impact upon the patient from risk~disclosure."). 6. patel v. gayes, 984 f.2d 214, 218 (7th cir. 1993). 7. shapardon v. w. beach estates, 172 f.r.d. 415,417 (d. haw. 1997). 8. fed. r. civ. p. 26(ax2)(b) (repealed 2010). 9. fed. r. civ. p. 26(ax2xc). 2012] treating physicians as witnesses 249 fact witness or an expert witness. part ii will examine the historical back­ ground of this issue, including (a) an examination of the case law prior to 1993, (b) the 1993 rule 26 amendments, (c) a survey of methods taken in response to the 1993 rule 26 amendments, (d) a survey of cases in the sev­ enth circuit, and (e) a consideration of the problems lingering from. these strategies. part iii will discuss the new addition to rule 26 and its potential ramifications. part iv will propose a framework for where to place treating physicians within the context of the amended federal rule of civil proce­ dure26. ii. background in order to improve this system, it is important to first understand the history behind it. before the december 2010 rule 26 amendments, there were two other important amendments that affected treating physicians un­ der rule 26,10 occurring first in 1970~ 11 and then in 1993.12 the expert wit­ ness status of treating physicians has drastically changed with each amendment.13 although both amendments set standards for disclosures of experts, each essentially left federal courts to decide on their own how to categorize a plaintiff's treating physician, creating problems that have lin­ gered to present day. a. case law prior to the 1993 rule 26 amendments until 1993, rule 26 did not affect the expert whose information was not obtained in anticipation of litigation "because he was an actor or viewer with respect to transactions or occurrences that are part of the subject matter of the lawsuit."14 these witnesses were instead treated as ordinary witness­ es.15 furthermore, experts did not need to produce reports before the 1993 amendments to rule 26.16 regardless of whether they were obtained in anticipation of litigation, parties were merely given equal opportunity to interview opposing experts through interrogatories.17 in these interrogato­ ries, experts could be asked to "state the subject matter on which the expert 10. see fed. r. civ. p. 26 (1970); fed. r. civ. p. 26 (repeal~ 1993); fed. r. civ. p. 26 (repealed 201 0). 11. fed. r. civ. p. 26(b)(4)(a) (repealed 1993). 12. fed. r. civ. p. 26(b)(4)(a) (repealed 2010). 13. see generally fed. r. civ. p. 26 (1970); fed. r. civ. p. 26 (repealed 1993); fed. r. civ. p. 26 (repealed 2010); fed. r. civ. p. 26. 14. fed.r. civ. p. 26 advisory committee's note (1970). 15. /d. 16. see generally fed. r. civ. p. 26 (repealed 1993). see, e.g., patel v. gayes, 984 f.2d 214,217 (7th cir. 1993); schurr v. niagara mach. & tool works, no. civ. a. no. 895422, 1991 wl 3875, at "'1-2 (b.d. penn. jan. 9, 1991). 17. 8a charles alan wright et al., federal practice & procedure § 2031.2 (3d ed. 2010). 250 indiana health law review [vol. 9:1 is expected to testify, and to state the substance of the facts and opinions to which the expert is expected to testify and a summary of the grounds for each opinion."18 before 1993, the seventh circuit determined whether a treating physi­ cian needed to be disclosed as an expert before trial under rule 26 by "fo­ cus[ing] not on the status of the witness, but rather on the substance of the testimony."19 accordingly, a doctor who was "acquired or developed in anticipation of litigation or for trial" would be more likely considered an expert.2° doctors gave '"classic' expert testimony'' by opining as to "the general medical standard of care within the community," since "[a] witness would formulate such an opinion only when preparing for litigation.'.zt b. the 1993 amendments to rule 26(a) the 1993 rule 26(a) amendments were considered by some to be con­ troversial and the "most sweeping changes since the rules first were adopted in 1938."22 newly amended rule 26(a)(2)(b) provided, unless otherwise stipulated or ordered by the court, this [expert] disclosure must be accompanied by a written report-prepared and signed by the witness­ if the witness is one retained or specially employed to provide expert testimony in the case or one whose du­ ties as the party's employee regularly involve giving expert testimony.23 these changes were quite a departure from the past requirements, as they greatly enhanced the disclosure requirements for retained experts by requiring an "extremely detailed report'' as opposed to "the rather general 18. ld (quoting fed. r. civ. p. 26(b)(4)(a) (1970) (repealed 1993)). see also nelco corp. v. slater elec. inc., 80 f.r.d. 411, 414 (e.d.n.y. 1978) ("[u]nder rule 26(b)(4)(a), a witness sought to be discovered may be an 'expert' as to some matters and an 'actor' as to others.''); patel, 984 f.2d at 218 ("under the federal rules, an expert must be identified if his testimony does not come ftom his personal knowledge of the case, or if his knowledge was acquired or developed in anticipation of litigation or for trial.") (citations omitted); ac­ cordquarantillo v. consol. rail coip., 106 f.r.d. 435,437 (w.d.n.y. 1985). 19. patel, 984 f.2d at 218. see also jenkins v. whittaker corp., 785 f.2d 720, 728 (9th cir. 1986), cert. denied, 419 u.s. 918 (1986); grinnell coip. v. hackett. 70 f.r.d. 326, 331 (d.r.i. 1976); quarantillo, 106 f .r.d. at 437 ("rule 26(b )(4) sets forth restrictions upon discovery of facts known and opinions held by experts that had been acquired or had been developed in anticipation of litigation or for trial. j. 20. patel, 984 f.2d at218 (quoting grinnell coip., 70 f.r.d. at 331). 21. !d. 22. joseph e. stevens, et al., practical aspects of the revisions to the federal rules of civil procedure effective 12/1193, 50 j. mo. b. 341, 341 (quoting randall samborn, bill to stop changes: new discovery rules talce effect, nat'll. j., dec. 6, 1993, at 3). 23. fed. r civ. p. 26(a)(2)(b) (repealed 2010). 2012] treating physicians as wi1nesses 251 interrogatory authorized by the 1970 provisions.'.24 these amendments were generated because under the former rule, "answering interrogatories about the 'substance' of expert testimony was frequently so sketchy and vague that it rarely dispensed with the need to depose the expert and often was even of little help in preparing for a deposition of the witness. "25 in tandem with the revised rule 37(c)(l), the rule 26 amendments also creat­ ed incentives for full disclosure, as "a party [would] not ordinarily be per­ mitted to use on direct examination any expert testimony not so disclosed. '.26 the formal report requirement included the need for his or her opinions, bases for his or her opinions, and all material "considered" by the expert.27 this report preparation requirement was particularly significant be­ cause before the change, experts were rarely asked to prepare an early re­ port, and when they did prepare such a report, it often "lock[ ed] the expert into opinions and subject[ ed] her to limiting cross-examination. "28 yet, the new requirements simultaneously left enormous ambiguity as to when a treating physician was a fact witness and as to when an expert needed to produce a report. c. survey of cases in united states federal courts without much formal guidance as to those witnesses who were not re­ tained in anticipation of litigation, federal courts had difficulty navigating the 1993 changes to rule 26.29 moreover, because the supreme court has not considered the role of treating physicians under rule 26, courts were left to determine what to do with treating physicians. as a result, courts have interpreted rule 26 in various ways. 30 an advisory committee note 24. 8a wright et al., supra note 17. 25. fed. r. civ. p. 26 (repealed 1993). see also meyers v. nat'l r.r. passenger corp. (amtrak), 619 f.3d 729, 734 (7th cir. 2010) ("the purpose of the report is to provide adequate notice of the substance of the expert's forthcoming testimony and to give the op­ posing party time to prepare for a response."). 26. fed. r. civ. p. 26 advisory committee's note (1993). see also meyers v. nat'l r.r. passenger corp. (amtrak), 619 f.3d 729, 734 (7th cir. 2010) (finding that the conse­ quences of not producing a report are also particularly important because failure to do so may result in the exclusion of the expert's testimony pursuant to rule 3 7( c )(1) ). 27. fed. r. civ. p. 26(a)(2)(b) (repealed 2010); eric k. yamamoto & joseph l. dwight, iv, procedural politics and federal rule 26: opting-out of "mandatory" disclo­ sure, 16 u. haw. l. rev. 167, 181 (1994). 28. yamamoto & dwight, supra note 27. 29. lee h. rosenthal, new areas of review by the advisory committee on civil rules, including rules 13, i5, 26(a)(2)(b), 48, and 62.1, and broader civil procedure pro­ jects, including time computation, summary judgment, and notice pleading, in civh.. practice and lmgation techniques in federal and state courts (ali-aba course of study, 2007). 30. see gregory p. joseph, emerging issues under the 1993 amendments to the fed­ eral civil rules, in current developments in federal civh..practice 1999 335, 370-71 252 indiana health law review [vol. 9:1 left some clues, however, stating that a treating physician "can be deposed or called to testify at trial without any requirement for a written report.'m most federal courts do require the disclosure of a treating physician as an expert by a patient.32 however, failure to disclose does not necessarily lead to the exclusion of that doctor.33 moreover, no clear consensus has been reached amongst federal courts on the expert report requirement, re­ sulting in the use of several approaches. 34 1. failure to disclose may not preclude treating physician from testifying for some courts, failure to disclose a treating physician as an expert witness does not necessarily prevent a party from utilizing the physician's factual testimony at trial. 35 courts following a more narrow approach con­ clude that those treating physicians whom parties fail to designate as an ex­ pert witness "generally may only· testify as to the observations they made regarding the plaintiff during the course of treatment."36 for example, in aumand v. dartmouth hitchcock medical center,· the court found that the disclosure of a treating physician was required under rule 26(a)(2)(a) be­ cause "a treating physician's diagnoses, prognoses, or other conclusions as to the patient's condition ... are examples of the physician's 'specialized knowledge,"' which are indicative of expert testimony under federal rule of evidence 702.37 however, those treating physicians who were not dis­ closed under rule 26(a)(2)(a) could still testify as fact witnesses regarding ''what they saw and what they did in the course of caring for a patient. "38 in addition, the court in kirkpatrick v. pfizer, inc. allowed the plain­ tiff's treating phy-sician to testify as to causation even though the plaintiff had failed to disclose the physician as an: expert under rule 26(a)(2)(a)?9 (pli litig. & admin. practice, course handbook ser. no. h0-002m, 1999). 31. fed. r. civ. p. 26 advisory committee's note (1993). 32. johnkimpflenet al., 10 federalprocedurelawyersedmon § 26:50 (201 0). see also lori g. cohen & christiana c. jacxsens, when is an expert not an ex­ pert? rule 26 disclosures of treating physicians, un's prod. liab. l. & strategy, july 2010 ("across jurisdictions, most courts have found that a treating physician may have ex­ pert opinions and should thus be disclosed as an expert witness under rule 26(ax2xa)."). see, e.g., redfoot v. b.f. ascher & co., no. c 05-2045 pjh, 2007 wl 1593239, at *13 (n.d. cal. june 1, 2007) ("treating physicians must be identified as expert witnesses pursu­ ant to rule 26(ax2xa)."). 33. kimpflen et al., supra note 32. 34. cohen & jacxsens, supra note 32. 35. kimpflen et al., supra note 32. see, e.g., noo v. standard tools & equip., co., inc.,·197 f.r.d. 263 (d. md. 2000). 36. dreiband, supra note 2, at 295. 37. aumand v. dartmouth hitchcock med. ctr., 611 f. supp. 2d 78, 88 (d.n.h. 2009). 38. id. 39. kirkpatrick v. pfizer, inc., no. civ.;.()9..92-c, 2009 wl 1290735, at *2-3 (w.d. okla. may 6, 2009). · 2012] treating physicians as witnesses 253 the court found that the plaintiff's expert need not be disclosed as an expert because he was the plaintiff's "long-term, treating physician and his testi­ mony [was] based on that history.'..w however, the court restricted the phy­ sician's testimony to "his treatment of [the plaintiff] and any observations he made during that treatment," as well as "medical testimony to explain his treatment." further, he could "not offer opinions which extend[ed] beyond the scope ofhis treatment of[the] [p]laintifl].'"'1 federal courts following a broader approach allow a treating physi­ cian's fact testimony to encompass ''any testimony based on the physician's care and treatment of the patient," and it is "[o]nly when the treating physi­ cian's proposed testimony goes outside of that broadly defined scope [that] disclosure under rule 26(a) (2)(a) is required.'"'2 for instance, in distin­ guishing whether a treating physician testified as a fact witness or an expert witness, the court in jones v. greyhound lines, inc. concluded that "a phy­ sician who testifies on information and opinions developed and drawn dur­ ing the treatment of the party as a patient is considered to be an ordinary fact witness rather than an expert.'"'3 recognizing that "no single bright line test" existed, the court found that it "must look to whether the medical opinions, conclusions and observations being offered by the treating physi.,. cian necessarily played a role in his or her care and treatment of the plain­ tiff.'.44 accordingly, the court concluded that it could not give the plaintiff "any advance determination" as to the necessity of expert reports. 45 2. after designation as an expert, should a report be produced? after designating the treating physician as an expert, courts also disa­ gree as to whether an expert report needs to be produced.46 some courts require a report only when a treating physician is testifying to causation, prognosis, and future disability.47 other courts find that as long as the treat­ ing physicians' testimonies are based on personal knowledge, there is no need to produce a report.48 one additional approach declares that whether a report needs to be provided depends on the extent of the treating physi40. /d. at *2. 41. id. 42. cohen & jacxsens, supra note 32. 43. jones v. greyhound lines, inc., no. 08-1185-mlb-dwb, 2009 wl 2195760, at *3 (d. k.an. july 22, 2009) (citations omitted). 44. /d. 45. /d. at *4-5 (citations omitted); cohen & jacxsens, supra note 32. 46. rosenthal, supra note 29, at 251 ("[t]bere are widely divergent views within the federal courts on whether a treating physician providing expert testimony is required to pro­ vide an expert report in advance of testifying under rule 26(ax2)(b)."). 47. kimpflen, supra note 32. see, e.g., griffith v. ne.lll. reg'l commuter r.r., 233 f.r.d. 513, 516 (n.d.lll. 2006). 48. kimpflen, supra note 32. see, e.g., hall v. sykes, 164 f.r.d. 46, 48-49 (e.d. va. 1995); salas v. united states, 165 f.r.d. 31,33-34 (w.d.n.y.l995). 254 indiana health law review [vol. 9:1 cian's testimony.49 the issue has even caused splits amongst district courts within the same court ofappeals.50 a. expert report required only when testifying to causation, progno­ sis, and/or future disability some districts only require an expert report when a treating physician opines as to causation, prognosis, or future disability.51 for instance, in upchurch v. hester, the court found that whether a treating physician must provide an expert report depended upon the "substance of the testimony" as opposed to "the status of the witness."52 thus, a treating physician whose testimony "reaches beyond the basic facts learned during the treatment of a patient, and extends to typical opinion testimony," must produce an expert report. 53 in united states v. henderson, the eleventh circuit held that "(a] treating physician is not considered an expert witness if he or she testifies about observations based on personal knowledge, including the treatment of the party."54 however, the role of a treating physician transforms when he begins to answer hypothetically, as the essential difference between expert and lay witnesses is that an expert may be asked hypothetical questions. 55 in bengston v. bazemore, the court found that rule 26 centered "not on the status of the witness, but rather the substance of the testimony."56 a treating physician testifying to his or her opinions concerning "the care and treatment of a patient" does not necessitate an expert report. 57 thus, no re­ port needs to be produced when a treating physician testifies to the exist­ ence or the cause of a patient's injury, but a report is necessary when a treating physician's testimony "extends beyond the facts disclosed during care and treatment of the patient."58 in brooks v. union pacific railroad company, the eighth circuit dis49. see, e.g., thomas v. consol. rail corp., 169 f.r.d. 1, 2 (d. mass. 1996); gonza­ lez v. exec. airlines, inc., 236 f.r.d. 73, 75-79 (d.p.r. 2006). 50. see, e.g., robbins v. ryan's family steak houses e., inc., 223 f.r.d. 448, 453 (s.d. miss. 2004). see also mass. continuing legal eouc., inc., the distrjct court speaks: distrjct of massachusetis § 2.1.1 (6th ed. 2011 ), available at dcs ma-cle 7. 51. see, e.g., upchurch v. hester, no. civa 05-252 jjf, 2006 wl 3020772, at *2 (d. del. oct. 23, 2006) (citation omitted); allen v. parkland sch. dist., 230 fed. app'x. 189, 194 (3rd cir. 2007); united states v. henderson, 409 f.3d 1293, 1299-1301 (11th cir. 2005). 52. upchurch, no. cna 05-252 jjf, 2006 wl 3020772, at *2 (citation omitted). 53. !d. accord allen, 230 fed. app'x. at 194. 54. henderson, 409 f.3d 1293 at 1300 (quoting davoli v. webb, 194 f.3d 1116, 1138 (loth cir.l999)). 55. id. 56. bengston v. bazemore, no. 3:06-cv-569-mef, 2007 wl 3307204, at *2 (m.d. ala. nov. 6, 2007). 57. !d. 58. !d. (citation omitted). 2012] treating physicians as witnesses 255 tinguished between a treating physician testifying "as a lay witness when describing a medical condition," and a treating physician offering an opin­ ion as to causation.59 thus, when a treating physician offered testimony "not merely to explain [the plaintiff's] medical condition" but also "to ex­ plain causation of [the plaintiff's] condition," that causation opinion "brought his testimony within rule 702 and rule 26(a)(2)," and a report was thus required. 60 while this requirement may lead to more certainty as to where to draw the line between those needing to produce expert reports and those that do not, patients may be prejudiced if a doctor who is not thought to initially need to produce an expert report later discovers he or she must testify as to causation. these necessary witnesses may be banned from testifying even when there would be no unfair prejudice to opposing sides. b. depends on the extent of the treating physician's testimony several courts have proposed that whether a treating physician is la­ beled as a fact witness or an expert depends upon the extent of his testimo­ ny.61 in these jurisdictions, the physician's fact testimony is "limited only to the physician's observations and actions in caring for the patient.'.62 consequently, a rule 26(a)(2)(a) disclosure would be necessary "even where the physician would be called upon to explain his or her diagnosis and prognosis for the patient.'.63 for example, in downey v. bob's discount furniture holdings, inc., the first circuit concluded that because an alleged expert's "opinion testimony [arose] not from his enlistment as an expert but, rather, from his ground-level involvement in the events giving rise to the litigation," he fell "outside the compass ofrule 26(a)(2)(b).'..64 in thomas v. consolidated rail corporation, the court found that an expert report was required of a treating physician testifying beyond obser­ vations made during his treatment of a plaintiff because he testified "at least in part, not merely based on observations made during the course of treat­ ment, but on professional expertise going beyond treatment per se.'.65 ac­ cordingly, a treating physician who "formulated opinions going beyond what was necessary to provide appropriate care for the injured party steps 59. brooks v. union pac. r.r. co., 620 f.3d 896, 900 (8th cir. 2010). 60. id at 900. 6 l cohen & jacxsens, supra note 32 (finding that ''to the extent that a treating physi­ cian testifies only to the care and treatment of a patient, the physician is not a 'specially em­ ployed' expert, and is not required to produce a written report prior to the admission of his or her testimony in an action by the patient"). 62. ld. 63. !d. see generally fielden v. csx transp., inc., 482 f.3d 866, 870-72 (6th cir. 2007) (discussing various strategies taken by different federal courts). 64. downeyv. bob's disc. furniture holdings, inc., 633 f.3d 1, 6 (1st cir. 2011). 65. thomas v. consol. rail corp., 169 f.r.d. 1, 2 (d. mass. 1996). 256 indiana health law review [vol. 9:1 into the shoes of a retained expert," thus requiring an expert report. 66 in gonzalez v. executive airlines, inc., the court concluded that a treating doctor was not required to produce an expert report when the phy­ sician testified only to the care and treatment of a patient.67 nevertheless, those opinions that treating physicians developed independently from their examination of the ·patient "constitute[ d] expert opinion testimony and [were] subject to the more stringent requirements of rule 26(b )( 4 )(c). ,,6& while this strategy does create a clear, bright-line standard, it also cre­ ates potential complications. it creates a report requirement for those treat­ ing physicians who testify as to causation or prognosis, even though these doctors may have opined as to causation or prognosis in their course of treatment of a patient. in addition, it may not easily be enforced, as it may be difficult to tell when a doctor goes beyond what was necessary to step into the shoes of a retained expert. c. no need to produce an expert report when treating physician's tes­ timony based upon personal knowledge a number of courts conclude that a treating physician may testify as to causation and prognosis without producing an expert report, provided that his testimony is based on his or her personal knowledge or observations made during the course of care and treatment, and so long as the physician was not "specially retained in connection with the litigation or for trial.',69 however, when the doctor opines "beyond the facts disclosed during the care and treatment of the patient" and "is specifically retained to develop opinion testimony, he or she is subject to the report requirement."70 in salas v. united states, the court concluded that if the physician's opinions were acquired directly through his treatment of the plaintiff, then he was not required to submit a written report.71 accordingly, a treating physician's opinions on causation and permanency do not necessarily ren­ der him or her an expert needing to produce a report simply because he or she "consider[ed] not just the plaintiff's diagnosis and prognosis, but also the cause."72 instead, "[t]he relevant question is whether [the] treating phy­ sicians acquired their opinions as to the cause of the plaintiff's injuries di­ rectly through their treatment of the plaintiff."73 in peck v. hudson city school district, the court found that the rule 66. id. see also goodman v. staples the office superstore, llc, no. 10-15021,2011 u.s. app. lexis 8979, at *19-21 (9th cir. may 3, 2011). 67. gonzalez v. exec. airlines, inc., 236 f.r.d. 73,75-79 (d.p.r. 2006). 68. id at79. 69. kimpflen, supra note 32. 70. id 71. salasv. united states, 165 f.r.d. 31,33 (w.d.n.y. 1995). 72. /d. 73. id. at 33-34. 2012] treating physicians as wllnesses 257 26(a)(2)(b) written report requirement applies when a doctor's opinion tes­ timony stretches "beyond the facts disclosed during care and treatment of the patient, and the doctor is specifically retained to develop opinion testi­ mony."74 however, in so far as a "treating physician testifies only to the care and treatment of the patient," he or she is not deemed "a 'specially em­ ployed' expert and is not subject to the written report requirements of rule 26(a)(2)(b), notwithstanding that the witness may offer opinion testimony under [the federal rules ofevidence]."75 in moore v. mckibbon brothers, inc., the court found that true treat­ ing physicians should not be required to submit an expert report, as the rule 26(a)(2)(b) requirement only implicated those experts who were "specifi­ cally retained" to testify as experts. 76 treating physicians generally "be­ come involved in the matter not as a witness, but in order to treat the plaintiff," because these "[t]reating physicians [were] really fact witnesses whose testimony flow[ ed] from information they learned during the course of their treatment.'m expert reports were not necessary provided that the treating physicians' "testimony relate[ d] to information learned during the scope of their treatment," which "include[ d] observations and opinions about diagnosis, causation, treatment, prognosis, costs of treatment and es­ timates of future such costs."78 in hall v. sykes, the court concluded that a treating physician who ''form[ ed] an opinion of the causation of an injury to a patient and the prog­ nosis of the patient's condition during the treatment," was not required to submit a rule 26(a)(2)(b) report.79 conversely, if that doctor, "even though he may be a treating physician," was "specially retained or employed to render a medical opinion based on factors that were not learned in the course of the treatment of the patient," then an expert report from that phy­ sician would be necessary.80 notably, however, just because a treating phy­ sician is paid a fee does not automatically establish that treating·physician as "a specially retained or employed expert" who must prepare an expert report.81 in davoli v. webb, the tenth circuit found that "[a] treating physician is not considered an expert witness if he or she testifies about observations based on personal knowledge, including the treatment of the party."82 thus, 74. peck v. hudson city sch. dist., 100 f. supp.2d 118, 121 (n.d.n.y. 2000). 75. ld. (citation omitted). 76. moore v. mckibbon bros., inc., 42 fed. r. serv. 3d 751, at *1 (e.d.n.c. 1999). 77. ld. 78. ld. at *2. 79. hall v. sykes, 164 f.r.d. 46, 48 (b.d. va. 1995}. 80. ld. at 46, 48-49. 81. ld. at 48. 82. davoli v. webb, 194f.3d 1116,1138 (lothcir. 1999)(citations omitted). see also weese v. schukman, 98 f.3d 542,550 (loth cir. 1996) (finding that a physician's lay opinions "were based on his experience as a physician and were clearly helpful to an under258 indiana health law review [vol. 9:1 even a treating doctor testifying as a lay witness, "may state 'expert' facts to the jury in order to explain his testimony" and "should be given loose rein to state what are truly facts, even if they are 'expert' facts.,..83 accordingly, under rule 701, each opinion the lay witness doctor gave was "based on his experience as a physician" and was "clearly helpful to an understanding of his decision making process in the situation. "84 in wreath v. united states, the court concluded that treating physi­ cians who testified "only to the care and treatment afforded to a party" were intentionally excluded from the expert report requirement pursuant to fed. r. civ. p. 26(a)(2)(b).85 those treating physicians who testify only ''to the care and treatment of his/her patient," are not considered specially retained experts even though they advance opinion testimony under fed. r. evid. 702, 703, or 705.86 conversely, a doctor whose "proposed opinion testimo­ ny extends beyond the facts made known to him during the course of the care and treatment of the patient," and who is "specially retained to develop specific opinion testimony," must produce a fed. r. civ. p. 26(a)(2)(b) expert report. 87 in farris v. intel corp., the court found that the rule 26(a)(2)(b) re­ port requirement "does not apply to treating physician[s]," because they are "hybrid witness[es],'' who may ''testify to 'fact opinions,"' including "cau­ sation, diagnosis, prognosis, and the extent of plaintiff's disability or injury derived from his observations and treatment.'.s8 however, the extent of a treating physician's opinion testimony is limited, as he or she is "not per­ mitted to provide expert testimony regarding any opinion he [or she] formed based on information learned outside of, and not related to, [the pa­ tient's] treatment" if they do not produce an expert report.89 in hawkins v. grace/and, the sixth circuit held that the necessity of an expert report by a treating physician depended upon ''the substance of the treating physician's testimony rather than his or-her status" and to not classify a treating physician as an expert under rule 26 "simply by virtue of his or her expertise. "90 the physician is thus not categorized as an expert witness '"if he or she testifies about observations based on personal knowledge, including the treatment of the party. "'91 instead, a doctor is only considered an expert subject to the rule 26 requirements when he standing ofhis decision making process in the situation''). 83. id. (citations omitted). 84. id. ( citatiens omitted). 85. wreath v. united states, 161 f.r.d. 448,449 (d. k.an. 1995). 86. !d. at 450. 87. id. 88. farris v. intel corp., 493 f. supp. 2d 1174, 1179-80 (d.n.m. 2007). 89. id. 90. hawkins v. graceland, 210 f.rd. 210, 211 (w.d. tenn. 2002). see also barnes v. cus nashville, llc, no. 3:09-cv-0764, 2011 u.s. dist. lexis 46457, *27-37 (m.d. tenn. apr. 29, 2011). 91. id. (quoting davoli v. webb, 194 f.3d ll16, ll38 (loth cir. 1999)). 2012] treating physicians as witnesses 259 opines "beyond the facts disclosed during care and treatment of the patient," and he or she "is specially retained to develop opinion testimony."92 simi­ larly, in mohney v. usa hockey, inc., the sixth circuit held that when a treating physician testifies as to his or her own personal knowledge, he or she may testify without being designated an expert.93 when the physician uses outside resources to inform him or herself, such as watching a vide­ otape of the incident,94 that doctor must be disclosed as an expert.95 in fielden v. csx transportation, inc., the court did not select a par­ ticular method to determine the status of treating physicians, but the sixth circuit discussed the strategies utilized by other courts.96 the court found that this case was not inconsistent with those jurisdictions that look to fun­ damental fairness of the circumstances because the scope of the testimony was of no surprise to the opposing party.97 the court also concluded that this case was not "inconsistent with those that have focused on the content of the physician's testimony," because both parties were aware of the con­ tent of the physician's testimony. 98 the sixth circuit a4ditionally conclud­ ed that a physician relying only upon his ordinary medical training would not qualify as an expert.99 finally, the court found that it was consistent with other courts who determine the status of experts by "whether a treating physician relies on tests, documents, books, videos, or other sources that the physician did not rely upon during his or her treatment of the patient" be­ cause there was "no evidence that [the physician] based his opinion as to the cause of [the] injury on any source other than his treatment."100 the sixth circuit, therefore, distinguished mohney because evidence existed that the treating physician "reached his conclusion about the cause of [the 92. /d. see also ridder v. city of springfield, 108 f.3d 1377, 1997 wl 117024, at *4 (6th cir. mar. 13, 1997) (upholding an order permitting plaintiff's treating physician to testi­ fy without rule 26(a)(2)(b) expert report disclosures "so long as they do not purport to testi­ fy beyond the scope of their own diagnosis and treatment"); mall v. am. honda motor co., no. 06-12332,2007 wl 1452941, at *1 (e.d. mich. may 17, 2007) (holding that treating physicians who were designated by plaintiff as experts were "not subject to the requirements of fed. r. civ. p .. 26(a)(2)(b) regarding reports"). but cf harville v. vanderbilt univ., inc., 95 f. app'x. 719, 724-725 (6th cir. 2003) (report requirement focused on the "substance of the testimony, rather than the status of the witness," and hinted that testimony regarding the standard of care fell "within the category of expert testimony that is required to be disclosed under rule 26"). 93. mohney v. usa hockey, inc., 138 f. app'x. 804, 811 (6th cir. 2005). 94. id. (concluding that because a treating physician "clearly was opining as to the mauner in which [plaintiff was injured] ... , based in part on his viewing of the video," and there was "no evidence that [the doctor] reached the same conclusions regarding causation at the time he treated [plaintift]," it was reasonable to conclude he was an expert witness sub­ ject to the expert report disclosure requirements). 95. id. at 810-11. 96. fielden v. csx transp., inc., 482 f.3d 866, 870-72 (6th cir. 2007). 97. id. 98. id. at 871-72. 99. id. at 872. 100. id. 260 indiana health law review [vol. 9:1 patient's] injuries at the time of the treatment."101 . this ·standard is more patient-friendly, as it allows more treating phy­ sicians to testify without the burden of an expert report. however, this standard may result in oversimplifications, for requiring a report from these doctors may result in unfair prejudice to patients because a true treating physician may consult outside information in order to more adequately and. efficiently treat his or her patient. on the other hand, opposing parties could argue that unfair prejudice exists because these doctors are technical­ ly providing scientific knowledge described under f .r.e; 702 without pro­ ducing an expert report. d splits within district courts of the same court of appeals and even the same district courts because. the courts of appeals have employed various methods to de­ termine whether a treating physician needs to produce a report, it is not sur­ prising that there are even splits of opinions amongst the district courts within each court of appeal, including the fifth circuit, or even the district courts, such as the district of massachusetts. though the fifth circuit sug­ gested that treating physicians .generally do need to be designated as ex­ perts, 102 some district courts have held that the designation of treating ·physicians .as experts is mandatory,103 while others have held that treating physicians only need to be disclosed when the expert is retained to develop an opinion.104 . for example, in robbins v. ryan's family steak houses east, inc., the court found that in the southern district of mississippi, ''treating physicians must be designated as expert witnesses[,] they must be so designated in a timely manner,"105 and must produce a report.106 conversely, in young v. u.s. the court determined that under rule 26, a treating physician "general­ ly must be considered an ordinary fact witness, and should not be consid­ ered an expert unless the physician has been specifically retained to develop an expert opinion."107 101. ld at 871. 102. hamburger v. state farm mut. auto. ins. co., 361 f.3d 875, 883 (5th cir. 2004) ("hamburger first explains that he tailed to timely designate dr. fitzgerald because his 'counsel did not believe that a treating physician was the type of witness from whom an expert report was necessary.' while this explanation addresses why hamburger did not obtain and serve a written report fi:om dr. fitzgerald pursuant to rule 26(ax2)(b), it does not address why hamburger tailed to timely designate dr. fitzgerald as a testifying expert under rule 26(a)(2xa), and no other explanation is given."). 103; see, e.g., robbins, 223 f.r.d. at 453; bunch v. metro. cas. ins. co., no. 5:10-cv104-dcb-.jmr; 2011 u.s. dist. lexis 40378, at *2-5 (s.d. miss. apr. 6, 2011). 104. see, e.g., youngv. united states, 181 f.r.d. 344,346 (w.d. tex. 1997). 105. robbins, 223 f.r.d. at 453. 106. id. 107: young,l81 f;r.d. at346. 2012] treating physicians as witnesses 261 interview questions posed to judges in the district of massachusetts highlight how prickly this problem can be within the same district court. 108 for example, judge earns "do[es] not require expert reports from treating physicians, only the production of the relevant medical records."109 simi­ larly, judge gorton does not require expert reports to be disclosed for phy­ sicians testifying as both treating physician and expert witness, and judge stearns does not require expert reports so long as it is "made clear by the offering party prior to any deposition that the treating physician will be asked to give expert opinions at trial."110 on the other hand, judges neiman, hillman, gertner, tauro, and o'toole require reports to be dis­ closed for physicians testifying as both treating physician and expert wit­ ness.111 the judges also had varying answers when asked about whether they "strictly limit the scope of expert testimony at trial matters explicitly disclosed in expert reports," or ''where appropriate permit an expert to testi­ fy on matters related to but not specifically described in the reports."112 for instance, judge young assures experts ''very strictly'' stick to their expert reports. 113 on the other hand, judge gorton allows an expert to testify out­ side their reports where appropriate, and judge saris "do[ es] not limit the expert testimony to the report if there has been a deposition."114 ultimately, it is clear that no uniform standard exists amongst the courts of appeals, and there is even. division amongst the district courts within the courts of appeals and their district courts. however, it appears that over the last few years, courts have gravitated towards allowing a treat­ ing physician to testify without producing an expert report, even as to cau­ sation and prognosis, so long as his testimony is based upon the treating physician's course of treatment of the patient.115 d. seventh circuit's management of treating physicians this division and uncertainty also exists in the seventh circuit be108. mass. continuing legal enuc., inc., supra note 50. 109. id 110. id 111. id. 112. id. 113. id 114. id 115. taylor v. union pacific r.r. co., no. 09-123-gpm, 2010 wl 5463132, at *2 (s.d. ill. dec. 29, 2010) (''typically, courts do not require a treating physician to provide an expert report where the physician's testimony about causation, prognosis, and the extent of disability is based on his or her treatment of a party.j. see, e.g., kansky v. showman, no. 3:09cv1863, 2011 u.s. dist. lexis 38814, *13-15 (m.d. penn. apr. 11, 2011); goodman v. staples the office superstore, llc, no. 10-1'5021, 2011 u.s. app. lexis 8979, at *1921 (9th cir. may 3, 2011); barnes v. cus nashville, llc, no. 3:09-cv-0764, 2011 u.s. dist. lexis 46457, *27-37 (m.d. tenn. apr. 29, 2011); bunch v. metro. cas. ins. co., no. 5:10-cv-104-dcb-jmr, 2011 u.s. dist. lexis 40378, at *2-5 (s.d. miss. apr. 6, 2011). 262 indiana health law review [vol. 9:1 cause the court has yet to provide clear guidance on treating physicians, and district courts have thus been forced to elect their own strategies. the lead­ ing seventh circuit opinion decided after the 1993 rule 26 amendment was musser v. gentiva health services. 116 in musser v. gentiva health services, the seventh circuit examined a medical malpractice claim in which a northern district of indiana judge had excluded the plaintiffs' treating physician because the plaintiffs had failed to disclose the treating physician as an expert.117 the plaintiffs had disclosed the treating physicians as fact witnesses, and the defendant pos­ sessed their medical records and had the opportunity to depose the doctors, but the seventh circuit determined that this was not sufficient to allow the treating physicians to testify. 118 instead, the court concluded that a treating physician should be disclosed as an expert when his or her testimony "con­ sists of opinions based on 'scientific, technical, or other specialized knowledge' regardless of whether those opinions were formed during the scope of interaction with a party prior to litigation."119 the court nonethe­ less found that a report is not always required of a treating physician, yet did not provide any further direction on the matter. 120 the seventh circuit simply stated that "some district courts have suggested that if the rule 26(a)(2)(a) testimony exceeds the scope of treatment and ventures into more general expert opinion testimony, a report may be necessary."121 subsequently, in blameuser v. hasenfang, the seventh circuit empha­ sized that it has "never held that treating physicians must file expert re­ ports."122 the court ultimately held that no expert report was required of a treating physician who based his testimony primarily on the medical chart he prepared and his treatment and diagnosis, which he reached during his treatment.123 however, the seventh circuit failed to offer any further sug­ gestions on treating physicians.124 judge easterbrook noted that "[a ]n inter­ esting question is what to do with a treating physician who proposes to testify in the manner of a hired expert, i.e., offering an opinion regarding what might have happened to the patient that does not rely on that physi­ cian's personal treatment of the patient."125 in meyers v. national r.r. passenger corp. (amtrak), the seventh 116. musser v. gentiva health servs., 356 f.3d 751 (7th cir. 2004). 117. jd.at754-55. 118. id. at 757-58 ("formal disclosure of experts is not pointless" because "[k]nowing the identity of the opponent's expert witnesses allows a party to properly prepare for trial[, and the defendants] should not be made to assume that each witness disclosed by the [plain­ tiffs] could be an expert witness at trial."). 119. jd at 757 n.2. 120. id. at 758 n.3. 121. jd 122. blameuser v. hasenfang, 345 f. app'x. 184, 186 (7th cir. 2009). 123. id at 187. 124. id. at 186-87. 125. jd at 187. 2012] treating physicians as witnesses 263 circuit specifically addressed whether a formal report under rule 26(a)(2)(b) was necessary for those treating physicians "[providing] an ex­ pert opinion as to causation . . . when the subject of such opinion was not determined at the time of treatment. "126 the court concluded that a treating physician, who provided expert testimony regarding causation but did not form that position in the course of his or her treatment of plaintiff, should be considered a retained or specially employed expert needing to provide a rule 26(a)(2) expert report.127 because the treating physicians "prepared letters with opinions as to the causation of [the plaintiffs] injuries at the request of [the plaintiffs] attorney, specifically for the purpose of litiga­ tion," and there was no evidence "suggesting that either doctor previously considered or determined the cause of [the plaintiffs] injuries during the course of treatment," the seventh circuit concluded that the plaintiff "was required to provide a proper expert report under rule 26(a)(2)."128 additionally, in banister v. burton, the seventh circuit found that no report was required because the doctor at issue was the treating physician, and he was not retained.129 the court concluded that meyers was distin­ guishable from banister because meyers concerned a physician's opinion "as to the cause of an injury determined for the purpose of litigation," which differs from a judgment "as to the effects of the injury at the time of treatment."130 moreover, the physician at issue "did not formulate his opin­ ion at the request of the [party] as the doctors in meyers had."m he had instead given "the same testimony at the state criminal trial .and when he was deposed by the parties."132 thus, the seventh circuit has left open whether a treating physician is in fact a witness or an expert because it never affirmatively or absolutely held that treating physicians were experts.133 furthermore, the court failed to definitively answer whether a report should be required of a treating phy­ sician who formed his opinion within the course of treatment of the pa­ tient.134 due to the lack of direction from the seventh circuit, there remains 126. meyers v. nat'l r.r,. passenger corp. (amtrak), 619 f.3d 729, 734 (7th cir. 2010). 127. id. at 734-35 (citations omitted). 128. !d. at 735; accord aurand v. norfolk s. ry. co., nos. 3:08-cv-398-pps, 3:08-cv-480-pps, 3:08-cv-485-pps2011, 2011 wl 2938447, at *11-13 (n.d. ind., july 18, 2011). 129. banister v. burton, 636 f.3d 828, 833 (7th cir. 2011). 130. id. 131. id. see also allison v. united states, no. 09-cv-3341, 2011 wl 1627083, at *4 (c.d. ill. apr. 28, 201 1) (concluding that because the expert had formed his opinion "after treatment had concluded, probably at the request of counsel," banister required an expert report). 132. banister, 636 f.3d at 833. 133. blameuser, 345 f. app'x. at 186 (noting that the seventh circuit has "held that in some circumstances, treating physicians must be disclosed as experts pursuant to rule 26(a)(2)(a)" (emphasis added)). 134. musser, 356 f.3d at 757 n.3. see also termini v. bd. of lake cnty. comm'rs, 264 indiana health law review [vol. 9:1 a split amongst the federal district courts within the seventh circuit.135 1. being retained creates a report requirement some district courts in the seventh circuit have held that whether a report is required depends on whether a treating physician was retained. for instance, in osuji v. city of chicago, the court held that "[b]ecause the doctors were not retained or specially employed, plaintiff need not have submitted a report under rule 26(a)(2)(b)."136 in addition, in logan v. illi­ nois central railroad co., the court based its decision to require an expert report partly upon the appearance that the treating physician had been re­ tained.137 2. causation creates a report requirement several judges have held that a treating physician must provide a re­ port when he or she provides testimony beyond his or her observations, di­ agnosis, or treatment and is expected to include opinions on issues such as causation, prognosis, and permanency.138 for example, in tzoumis v. no. 2:09-cv-10-pps-prc, 2010 wl 2674507, at *3 (n.d. ind. june 29, 2010) ("[t]he sev­ enth circuit court of appeals has yet to definitely decide whether a treating physician must provide an expert report under rule 26(a)(2)(b) in order to testify as to causation, future medical care and prognosis, or permanency of injury or disability."). 135. mccloughan v. city of springfield, 208 f.r.d. 236,241-42 (c.d. ill. 2002) (dis­ cussing the different methods utilized by district courts in the seventh circuit). see also eagle servs. corp. v. h20 indus. servs., inc., no. 2:02-cv-36-prc, 2005 wl 5988646, at *2 (n.d. ind. sept. 30, 2005) (discussing the different strategies offederal courts in the sev­ enth circuit). at times, it is unclear which strategy courts are employing. see, e.g., rahoi v. sirin, 252 f.r.d. 464,468-69 (w.d. wis. 2008) (concluding that the testimony from the patient's treating physicians that "might offer outside the scope of their treatment of plaintiff must be barred" because it was likely that the doctors "would be asked to testify as experts about the standard of care for a torn rotator cuff and how plaintiff's treatment in prison relat­ ed to that care;" yet, allowing the treating physicians to testify so long as they did not "pre­ sent testimony outside the scope of his treatment of plaintiff''). 136. osuji v. city of chicago, no. 02 c 4199,2005 wl 1799277, at *6 (n.d. ill. july 26, 2005). 137. logan v. illinois cent. r.r. co., no. 305-cv-902-drh, 2006 wl 3841593, at *4 (s.d. ill. dec. 14, 2006) review denied, order aff'd sub nom. logan v. illinois cent. r. co., inc., no. 05cv0902 drh, 2007 wl 30539 (s.d. ill. jan. 4, 2007) (finding that the plain­ tiffs doctor was a retained expert requiring a rule 26(a)(2)(b) report because the expert disclosure went "beyond medical records, testing, examinations that were performed during the treatment of a plaintiff," because of the physician's "reference to texts, documents, and reference books within her profession; market surveys, job market analyses, government publications"). 138. eagle servs corp., no. 2:02-cv-36-prc, 2005 wl 5988646, at *4. see, e.g., sowell v. burlington n. and santa fe ry. co., no. 03 c 3923, 2004 wl 2812090, at *3 (n.d. ill. dec. 7, 2004); brandon v. village of maywood, 179 f. supp. 2d 847, 859 (n.d. ill. 2001); rebolledo v. herr-voss corp., 101 f. supp. 2d 1034, 1039 (n.d. ill. 2000); bar­ rett v. int'l armaments, inc., no. 95 c 2690, 1999 wl 199253, at *6 {n.d. ill. mar. 31, 1999); murray v. chicago transit auth., no. 97 c 7923, 1999 wl 49355, at *i (n.d. ill. jan. 29, 1999); schoolman v. uarco, inc., no: 94 c 5598, 1999 wl 47124, at *3 (n.d. ill. 2012] treating physicians as witnesses 265 tempel steel co., a northern district of illinois judge held that "[a] treating physician is not automatically an 'expert' witness simply because he is a doctor." even when he is not disclosed as an expert, a treating physician "may still testify regarding his observations made during the course of treatment and on matters in his personal knowledge."139 however, once a physician's testimony "goes beyond his personal observations, treatment, and diagnosis," it "slips over into matters normally considered 'expert' tes­ timony," and hence "may be barred."140 in griffith v. northeast illinois regional commuter r.r., a northern district of illinois judge held that a treating physician was not required to produce a written report under fed r. civ. p. 26 when the physician lim­ ited his testimony to matters dealing with the care and treatment of a pa­ tient.141 however, when the treating physician opines as to causation, prognosis, or future disability, "[h]e is going beyond his personal involve­ ment in the facts of the case and giving an opinion formed because there is a lawsuit" and therefore must comply with the requirements of fed. r. civ. p. 26(a)(2)(b).142 in bell v. columbia st. mary's hosp. milwaukee, inc., the plaintiff ar­ gued that the treating physician's treatment records should suffice instead of a report because ''the defendants [could] effectively prepare for cross examination through reviewing the treating physicians' treatment records and deposing the doctors.''143 however, since the treating physicians were to be "called upon to offer expert testimony regarding their opinions drawn from their treatment of [the patient], the prognosis of bell's injury, and po­ tentially to offer testimony regarding the causation of [the plaintiff's] injury and future disability," an eastern district ofwisconsinjudge required these treating physicians to provide rule 26(a)(2)(b) reports. 144 furthermore, a few northern district of indiana judges have held that treating physicians must be designated as experts, and whether a treating physician needs to produce an expert report depends on the extent of his testimony: if a physician testifies' beyond his scope of treatment to causa­ tion, prognosis, or permanency, he or she will be required to produce an expert report.145 for instance, in eagles services corp. v. h20 industrial jan. 20, 1999); zarecki v. nat'l r.r passenger corp., 914 f. supp. 1566, 1573 (n.d. ill. 1996) (holding that a.treating physician could not testify regarding causation because he was not disclosed as an expert pursuant to rule 26(ax2), and the doctor was "purporting to speak as an expert on these issues based on some unspecified body of professional knowledge"). · 139. tzoumis v. tempel steel co., 168 f. supp. 2d 871, 876 (n.d. ill. 2001). 140. id 141. griffith v. ne. dlinois reg'l commuter rr., 233 f.rd. 513, 516-19 (n.d. dl. 2006). 142. id at 518. 143. bell v. columbia st. mary's hosp. milwaukee, inc., no. 07-cv-81, 2008 wl 163671, at *3 (b.d. wis. jan. 16, 2008). 144. id. 145. matthew king. doctor, cqn i get that in writing?, dtci: testifying physicians must provide written reports for opinions, ind. law., http://www.theindianalawyer.com/ 266 indiana health law review [vol. 9:1 services, inc., the court found "more persuasive the reasoning of those cas­ es ... disallowing causation testimony because [the expert's] testimony would go beyond her knowledge directly related to her involvement with the plaintiff's business prior to the litigation and such opinions would be for the purpose of the litigation."146 3. disclosure depends on how the information was obtained it seems that the majority of district courts within the seventh circuit are moving towards a standard that allows treating physicians to offer opin­ ion testimony on causation, diagnosis, and prognosis of their patients with­ out providing an expert report so long as their testimony is based upon their personal knowledge of the facts surrounding the injuries and treatment of the patient.147 for instance, in mccloughan v. city of springfield, the court found that, plaintiff's treating physicians, who had not filed rule 26 expert­ witness disclosure reports, could offer opinions on causation, diagnosis and prognosis.148 generally, no expert report was required of a treating physi­ cian provided that his or her "planned testimony was acquired, not in prepa­ ration for trial, but rather because he was an actor or viewer with respect to transactions or occurrences that are a part of the subject matter of the lawdoctor-can-i-get-that-in-writing-testifying-physicians-must-provide-written-reports-for­ opinions-beyond-personal-observations-and-treatment!p arams/article/23796 (last visited oct. 30, 2011). 146. eagle servs. corp. v. h20 indus. servs., inc., no. 2:02-cv-36-prc, 2005 wl 5988646, at *5 (n.d. ind. sept. 30, 2005). see also colter v. rockwell automation, inc., no. 3:08-cv-527 nb, 2009 wl 7450978, at *3 (n.d. ind. nov. 18, 2009) (requiring that "treating physicians testi:(ying to causation, prognosis, and permanency file expert reports satisfying the requirements of rule 26(ax2)(b)"). 147. martin v. csx transp., inc., 215 f.rd. 554,556 (s.d. ind. 2003) {"the majority of courts permit physicians to present their opinions formulated during the course of treating a patient."). see also eagle servs. corp., no. 2:02-cv-36-prc, 2005 wl 5988646, at *3; taylorv. union pacific r. co., no. 09-123-gpm, 2010 wl 5463132, at *2 (s.d.lll. dec. 29, 2010); krische1 v. hennessy, 533 f. supp.2d 790, 794-95 (n.d. ill. 2008). see, e.g., denson v. ne. ill. reg'l commuter r.r. corp., no. 00 c 2984, 2003 wl 1732984, at *1 (n.d. lll. mar. 31, 2003) ("there is no indication that any of the three treating physicians from whom plaintiff may elicit expert opinions was retained or specially employed for that purpose," and thus "the report requirement does not apply for their testimony."); zurba v. united states, 202 f.r.d. 590,592 (n.d. ill. 2001) (finding that "[d]eveloping an opinion as to the cause of the patient's injury based on a physical examination ... is 'a necessary part of treatment' and does not make the treating physician an expert," and that the "same may be true regarding the permanency of the plaintiff's condition"); sircher v. city of chicago, no. 97 c 6694, 1999 wl 569568, at *l-2 (n.d. ill. july 28, 1999) ("[pjroposed opinion testi­ mony [coming] from his knowledge acquired as a treating physician, is not someone from whom a rule 26{a)(2xb) formal report is required."); crespo v. city of chicago, no. 96 c 2787, 1997 wl 537343, at *3 (n.d. ill. aug. 22, 1997) (citation omitted) (concluding that treating physicians "may testify as to their personal knowledge of the patient," including "opinion[sj as to the cause of an injury based upon their examination of the patient or to the degree of injury in the future," because "[t]hese opinions are a necessary part of the treat­ ment of the patient ... [and] 4o not make the treating physicians experts"). 148. mccloughan v. city of springfield, 208 f.r.d. 236, 240-42 (c.d. ill. 2002). 2012] treating physicians as wl1nesses 267 suit.u149 the court concluded that "instead of focusing on whether a witness is an 'expert' under the federal ru1es of evidence, the question, in reality, is: whether the witness whose opinion is sought to be elicited is someone from whom a report is required under fed. r. civ. p. ('rule') 26(a)(2)(b),'' or in other words, whether the witness "is retained or specifically employed to provide expert testimony in the case."150 as a resu1t, a treating physician "may offer opinion testimony on causation, diagnosis, and prognosis with­ out the prerequisite of providing a ru1e 26(a)(2)(b) report."151 in gary v. alexander, the court considered whether reports were re­ quired of the plaintiff's treating physicians. 152 even though the court rec­ ognized that "a party must still disclose the treating physician as an expert witness under rule 26(a)(2)(a)," it held that "ru1e 26(a)(2)(b) does not apply to treating physicians who provide opinion testimony formulated in connection with treatment, including opinions on causation, diagnosis, and prognosis.153 similarly, in osterhouse v. grover, the court considered whether plaintiffs' treating physicians shou1d be excluded from testifying because they did not produce expert reports.154 the court concluded that the plain­ tiffs' treating physicians were not retained because they were testifying "based on the medical records, testing, [or] examinations that were per­ formed during the treatment of a plaintiff and not necessarily in anticipation of litigation."155 further, there was no indication that the plaintiffs had "so­ licited the services of any of the doctors s<>lely because they intended to file suit."156 moreover, testimony as to causation or prognoses generally failed to "elevate these doctors" to the status of a retained expert because it is not uncommon for a doctor to obtain information and to develop opinions re­ garding the "processes of an injury" as well as '"the future ramifications of 149. id. at 241 (citations omitted). 150. id (citations omitted). 151. !d. at 242. 152. gary v. alexander, no. 08-3241, 2009 wl 1162387, at *1 (c.d. ill. apr. 24, 2009). 153. id. see also dereak v. don mattox trucking. llc, 69 fed. r. serv. 3d 394, at *7 (c.d. ill. oct. 30, 2007) (concluding that because no expert reports were produced, treating physicians were "limited to the substance and opinions disclosed by plaintiffs in the answers to interrogatories, in each witness's report and his or her records disclosed to defendant, and in each witness's deposition testimony''); ridings v. riverside med. ctr., no. 05-2134, 2006 wl 1084323, at *1 (c.d. ill. apr. 25, 2006). 154. osterhouse v. grover, no. 3:04-cv-93-m.jr. 2006 wl 1388841, at *1 (s.d. ill. may 17, 2006). see also williams v. schram, no. 06-cv-00557-drh, 2008 wl 2691887, at *3 (s.d. ill. june 30, 2008) (finding that treating physicians were only "allowed to testify as to the treatment they have personally provided to plaintiff as a patient in their care," but could not "testify as to their opinions based on their review of any other doctor's treatment or recommendation"). 155. osterhouse, no. 3:04-cv-93-m.jr. 2006 wl 1388841, at *3. 156. id. 268 indiana health law review [vol. 9:1 an injury" during his or her course of treatment of a patient. 157 occasionally, some southern district of indiana judges have allowed treating physicians who were designated as experts to testify regarding cau­ sation, permanency, and prognosis without producing expert reports. 158 moreover, they have permitted treating physicians to opine as to causation, diagnosis, and prognosis without providing a ru1e 26 report. 159 for in­ stance, in martin v. csx transportation, inc., magistrate judge baker wrote that "[i]t is within the normal range of duties for a health care provid­ er to develop opinions regarding causation and prognosis during the ordi­ nary course of an examination," as ''to properly treat and diagnose a patient, the doctor needs to understand the cause of a patient's injuries."160 as a result, a physician "whose proposed opinion testimony will come from his knowledge acquired as a treating physician, is not someone from whom a rule 26(a)(2)(b) report is required."161 similarly, in mcquiston v. helms, the court concluded that a physician "'whose proposed opinion testimony will come from his knowledge ac­ quired as a treating physician, is not someone from whom a ru1e 26(a)(2)(b) report is required."'162 because the physician witness in mcquiston did not rely upon information gathered ex parte from the ex­ pert's treatment of the patient, no expert report was required. 163 without clear or conclusive guidance from the seventh circuit, the district courts have employed varying strategies to· determine whether treat­ ing physicians must produce expert reports. moreover, this lack of guid­ ance has caused many judges within the same district courts to differ in managing the report requirement for treating physicians. however, recently courts appear to be gravitating toward a standard that requires no expert report unless the doctor has testified outside his or her· course of treatment of the plaintiff. 157. ld. 158. king, supra note 145. 159. dale conder, jr., frcp requirements: expert disclosures under rule 26, for the defense (july 2004); see martin v. csx transp., inc., 215 f.r.d. 554,551 (s.d. ind. 2003). 160. martin, 215 f.r.d. at 557. 161. !d. (quoting sircher v. city of chicago, no. 97 c 6694, 1999 wl 569568, at *2 (n.d. ill july 28, 1999) ). see also butterfield v. navistar int'l transp. corp., no. i :06-cv101-rly-wtl, 2007 wl2901693, at *2 (s.d. ind. june 25, 2007) (holding that because the plaintiff had not indicated he was going to offer "any testimony from his physician­ experts beyond the appropriate scope of such testimony," no expert report was necessary). 162. mcquiston v. helms, no. 1:06-cv-1668-ljm-dml, 2009 wl 554101, at *10 (s.d. ind. mar. 4, 2009) (quoting martin v. csx trans., inc., 215 f.r.d. 554, 557 (s.d. ind. 2003)). 163. !d. 2012] treating physicians as witnesses 269 e. lingering problems because of the lack of clear standards, problems have lingered and are likely to continue, notwithstanding the 2010 rule 26 amendments.164 even where courts have annunciated their own uniform standards, it remains dif­ ficult to determine whether a report is required because "[t]he dividing line may be between knowledge that [a] doctor has solely as a result of treating the patient, and analyses or insights the doctor develops at the behest of the patient's lawyer."165 moreover, physician witnesses are often difficult to compartmentalize as lay witnesses or expert witnesses because they often toe the line between retained experts and treating physician witnesses.166 additionally, preparing an expert witness report in accordance with rule 26(b)(2)(b) is time consuming even though counsel is allowed to assist the expert witness because the rule requires that a doctor be "extremely thor­ ough."t67 many attorneys throughout the country are still struggling with these standards.168 questions have been left open in the seventh circuit, includ­ ing determining how far a treating physician may testify without producing an expert report.169 for example, could a treating physician "offer any opinions that are based solely on 'the facts made known to him [or her] dur­ ing the course of the care and treatment,' even if the opinions are not essen­ tial to care and treatment . . . as long as the physician has not been 'specially retained' to develop that opinion?"170 in addition, what does "specially retained ... to provide expert testimony'' mean?m for example, if a patient's back was healthy before an accident but is fractured after the accident, and a doctor diagnoses the fracture and that he knows of no other medical causes that may be relevant to the treatment, would this be an opin­ ion that transforms the doctor into an expert?172 moreover, if a d,octor diag164. see mass. continuing legal educ., inc., supra note 50. 165. sa wrightetal.,supranote 17. 166. see generally jay e. gr.en!g & jeffreys. kinsler. handbook of federal cml discovery and disclosure§ 1:23 (3d ed. 2011). see, e.g., noffsinger v. valspar corp., no. 09 c 916, 2011 wl 9795, at *4 (n.d. dl. jan. 3, 2011) (finding that the doctor's records "show characteristics of both a treating physician and an expert hired to opine about causation"). 167. sa wright et al., supra note 17. 168. see james beck & mark herrman, treating physicians as experts, drug & device l. blog (aug. 25, 2009, 8:00am), http:/ldruganddevicelaw.blogspot.com/2009/08/ treating-physicians-as-experts.html. see generally king, supra note 145. 169. cobble v. wal-mart stores e., l.p., no. 1:10-cv-010, 2010 wl 1088513, at *2 (n.d. ind. mar. 19, 2010) ("[d]istrict courts in the seventh circuit have not adopted a uni­ . fonn approach with respect to treating physicians and the expert report requirements of rule 26(a)(2xb)."). 170. joseph, supra note 30, at 370. 171. ld at 371. 172. this example was conceptualized through discussions with indianapolis-area attorneys. 270 indiana health law review [vol. 9:1 noses lung cancer in a nonsmoker, does the diagnosis qualify as an expert opinion if the doctor concludes that it was caused by workplace expo­ sure?173 this struggle to understand the implications of rule 26 has also en­ couraged the tactical gamesmanship that is utilized by attorneys in an effort to avoid placing the label of expert on their treating physicians.174 exam­ ples of tactics utilized by attorneys include"retaining two experts (one to testify and one as a consultant to do the work and develop the opinion), im­ posing contrived record-keeping practices, and wasting valuable deposition time exploring every communication between a lawyer and expert and eve­ ry change to an expert report."175 as a result, the amendments have had "a chilling effect_ on counsel's interactions with testifying experts," and attor­ neys have employed ''various costly and counterproductive strategies to avoid making disclosures under the rule."176 this issue thus raises practical questions of how to avoid causing prej­ udice to both plaintiffs and defendants. for instance, if treating physicians are labeled fact witnesses or expert witnesses who do not need to produce expert reports, defendants may be prejudiced as a result because plaintiffs could purposefully circumvent full disclosure or use this quasi-loophole as an excuse to add an expert physician at the eleventh hour before a discovery deadline. 177 the lack of a report requirement may even be exploited to sneak in an expert physician after a dead1ine.178 alternatively, labeling a treating physician as an expert required to produce a report may prejudice plaintiffs whose treating physicians lack the time to complete an extensive expert report. 179 moreover, treating physicians themselves may be reluctant to be des173. this example was conceptualized through discussions with indianapolis-area attorneys. 174. joseph, supra note 30, at 372 (noting that the distinction between a true treating physician and the hired gun is "subject to manipulation (since a patient can always start treating with a new, lawyer-suggested doctor)j. 115. stephen g. harvey & angelo a. stio m, amendments to federal rules of civil procedure to takee.ffect on december 1, 2010, pepper hamilton llp client alert, dec. 1, 2010, at 1, available at http://www.pepperlaw.com/publications_update.aspx?articlekey= 1953. 176. david spears & christopher w. dysard, expert testimony in civil and criminal cases in the federal courts, in expert witness 2011, at 39 (pli litig. & admin. practice, course handbook ser. no. 31219,2011). 177. see, e.g., noffsinger v. valspar corp., no. 09 c 916, 2011 wl 9795, at *4-5 (n.d. ill. jan. 3, 2011) (where defendants claimed that patient's reputed treating physician was not actually a treating physician but was solely retained in anticipation, causing the "treatment" to be a fa9ade ). 178. see, e.g., id. (where defendants claimed that patient's reputed treating physician was not actually a treating physician but was solely retained in anticipation, and therefore the "treatment'' was a fa~e). 179. cohen & jacxsens, supra note 32 ("this will aid defense counsel both in develop­ ing strategy regarding their rule 26 disclosures of treating physicians and in capitalizing on the opposing side's errors regarding disclosures of treating physicians."). 2012] treating physicians as witnesses 271 ignated experts, and it is commonly difficult for attorneys to convince treat­ ing doctors to take the time to prepare for trial and to produce a detailed report before the treating physicians are even asked to testify. 180 the report requirement may also negatively affect the health of patients because it takes time away from treatment and patient care.181 these resulting diffi­ culties may affect the ability of patients to bring claims or defenses.182 fur­ thermore, the whole purpose behind rule 26 seems to be defeated if true treating physicians are required to produce experts report because they were not retained in anticipation of litigation, when the 1993 rule 26 advisory committee appeared to purposely exclude expert physicians from this extra burden.183 finally, it is highly problematic that whether an expert report is re­ quired is dependent upon the district court in which the case was filed or the judge to whom it was assigned. 184 thus, courts may be encouraging forum or judge shopping, and, as such, justice may not be meted out equally amongst patients if a court later decides to prevent a treating physician from testifying due to the lack of an expert report. ill. changes to rule 26(a) and its potential ramifications the proposed amendments to rule 26( a) that took effect in december 2010 may change the way courts view treating physicians. as a new addi­ tion to this section, rule 26(a)(2)(c) provides that even an expert who is not required to produce an expert report under rule 26(a)(2)(b) must still provide "a summary of the facts and opinions to which the witness is ex­ pected to testify."185 hence, regardless of whether a treating physician needs to produce an expert report, there must be some cursory information provided by treating physicians to opposing parties. this new obligation is "similar in substance to the pre-1993 version of rule 26(b)(4)(a)," allowing for expert discovery through interrogatories!86 180. fed. r. cn. p. 26 advisory committee's note (1993). see also katherine a. roc­ co, rule 26(a)(2)(b) of the federal rules of civil procedure: in the interest of full disclo­ sure?, 16 fordham l. rev. 2227, 2228-29 (2008). 181. rocco, supra note 180. see also watson v. united states, 485 f.3d 1100, 1107 (loth cir. 2007). 182. fed. r. cn. p. 26 advisory committee's note (1993). 183. id see also 8a wrigiit et al., supra note 17 ("it seemed clear that the treating physician example was one reason why the advisory committee did not impose a report requirement on all testifying experts in 1993. "). 184. spears & dysard, supra note 176, at 40 ("[s]ome courts have required written reports even from exempted expert witnesses (for example, the plaintiff's treating physi­ cian)."). see, e.g., sowell v. burlington n. & santa fe ry. co., no. 03 c 3923, 2004 wl 2812090, at *4 (n.d. ill. dec. 7, 2004). 185. fed. r. cn. p. 26(a)(2)(c). 186. gregory p. joseph, 2010 expert witness rule amendments: the new rules will eliminate much of the need for maneuvers once used to protect communications with experts, prac. lmgator. nov. 2010, at 55. 272 indiana health law review [vol. 9:1 however, the new obligation does not force a complete expert report from any expert witness who was previously exempted under the 1993 version of rule 26(a)(2)(b).187 this added requirement may help "resolve[] a tension that has sometimes prompted courts to require reports under rule 26(a)(2)(b) even from witnesses exempted from the report requirement," and a full report would still only be necessary from an expert described un­ der rule 26(a)(2)(b).188 the 2010 advisory committee note concluded that this report is less burdensome than the export report requirement. 189 however, the committee cautioned courts to guard against making this re­ quirement too onerous, urging them to ••take care against requiring undue detail," and "[to] keep[] in mind that these witnesses have not been special­ ly retained and may not be as responsive to counsel as those who have."190 therefore, as long as these witnesses are identified under rule 26(a)(2)(a) and provide the necessary disclosure under rule 26(a)(2)(c), the witnesses may enjoy their hybrid status as a fact witness and an expert witness with­ out being required to produce a rule 26(a)(2)(b) report. 191 accordingly, this new rule establishes a compromise, requiring a less burdensome expert report to be produced by a patient's treating physician, while concurrently giving the opposing party sufficient notice as to the con­ tent of the doctor's testimony. 192 some further mitigation for patients exists because a treating physician who testifies as both as an expert witness and a fact witness is not required to disclose the facts to which he or she is testify­ ing as a fact witness.193 in other words, the "disclosure obligation does not include facts unrelated to the expert opinions the witness will present."194 potential prejudices exist for both parties due to these 2010 rule 26 amendments. 195 there is now a written summary requirement for doctors who become ensnared in time-consuming litigation purely because of their profession, which requires treatment of patients. this added obligation may make doctors even more reluctant to testify. 196 in addition, patients must 187. 8a wright et al., supra note 17. 188. fed. r. crv. p. 26 advisory committee's notes (2010). 189. id 190. /d. 191. id 192. jessie f. beeber & marisa sarig, recent amendments to rule 26: how the new rules affect the attorney-expert relationship, in expert witness 2011, at 129-30 (pli litig. & admin. practice, course handbook ser. no. 31219,2011). 193. id 194. fed. r. civ. p.26 advisory committee's notes (2010). 195. beeber & sarig, supra note 192, at 130. 196. see proposed amendment to frcp 26what is it and how will it affect litiga­ tion?, nixon peabody llc prod. lias. alert, nov. 5, 2008, at 2, available at http://www .nixonpeabody.com/linked _media/publications/products_ liability_ alert _11_ 05 _ 2008.pdf ("a physician who may be considered a 'lay witness' under rule 26(a)(2)(b}­ testifying to a patient's diagnosis and treatment-may now be considered an 'expert' testify­ ing to all opinions and the basis and reasoning for each. if a physician is considered an 'ex­ pert,' he or she may also have to provide a list of all publications written in the previous 10 2012] treating physicians as witnesses 273 disclose the extent of the physician's expert testimony in this summary statement, and this physician will likely be restricted to testifying to only the information included in this statement.197 consequently, patients suffer· ing from new symptoms or receiving new diagnoses subsequent to the dis .. closure of the summary report may be prejudiced. moreover, this process may be difficult for physicians because they will likely be asked to verify disclosures drafted by attorneys, whereas the physicians had previously drafted their own disclosures or verified their own records.198 there will also be an added expense for whoever formulates this summary report, thereby adding to the potential costs of litigation.199 the summary report requirement may also be more burdensome, particularly in cases where there are several treating physicians.l00 however, the rule 26 amendments simultaneously "may save both time and money associated with retaining experts and discovering their opinions."201 because these requirements are less burdensome than the cur .. rent rule and may be drafted by attorneys, the time and money required· to allow a patient's treating physician to testify will be significantly less.202 further, as opposing parties will have access to the extent of a treating phy .. sician's testimony, less unfair surprises will occur, and "[s]uch summary reports may even eliminate the need for depositions.'.203 party opponents stand to gain much information from this summary statement that they did not receive in the past when a party was determined to avoid producing an expert report. 204 defendants will now be able to ob .. tain a general idea of the extent of a treating physician • s expert testimony, but courts may be more reluctant to designate treating physicians as experts needing to produce a full .. blown expert report. in these cases, defendants in years and a list of cases in which he or she has· testified at trial or deposition in the previous four years."). 197. fed. r. civ. p. 26(a)(2)(c). 198. !d. those covered under this rule will have to communicate to develop the written disclosure, but it does not need to be signed by the witness. id. 199. proposed amendment to frcp 26what is it and how will it affect litigation?, supra note 196. 200. see generally michael a. pollard et al., proposed amendments to federal rule of civil procedure 26 to substantially change expert witness disclosure and discovery re­ quirements, baker & mckenzie client alert, july 2010, available at http:// www .bakermckenzie.com/files/publicationldae4bb76-43bf-40de-9c38-0780543b4166 !presentation!publicationattachment/06375892-844e-4307-b4d9-12c750a7d5d7/al dr __proposedamendmentsfederalrulecivilprocedure _jul1 o.pd£ 201. lance l. shea et al., an lndispensible force of persuasion: navigating expert discovery, for the defense, nov. 2010, at 14. 202. see generally id. 203. proposed amendment to frcp 26what is it and how will it affect litigation?, supra note 196. 204. see proposed amendment to frcp 26what is it and how will it affect litiga­ tion?, supra note 196 ("the opposing party will be in a position to gather additional facts and witnesses as necessary, as they will be aware of potentially harmful or surprising opin­ ions."). 274 indiana health law revjew [vol. 9:1 some jurisdictions may actually have even less access to information. 205 yet, because the new rule 26(a)(2)(c) "draws no distinction between par­ ties, in theory, defendants will have the same ability as plaintiffs to desig­ nate and describe the opinion testimony of plaintiffs' treating physicians. "206 however, questions regarding this process still remain, and much will be left to the discretion of courts.207 for instance, it will likely be difficult to separate 'unrelated' facts from related facts which "could prompt the op­ ponent to challenge, through motion practice, the sufficiency of presenting side's summary disclosures.'o208 overall, it seems that while this new requirement may obviate some of the confusion that was created by the rule 26 (a)(2)(b), the summary report requirement has potentially created new prejudices by different means. ul­ timately, it appears that courts will again have to decipher an unclear stand­ ard in rule 26(a)(2)(c) and create their own schematics. similar to the splits of opinion that occurred after the adoption of rule 26(a)(2)(b), divi­ sions amongst courts and the use of various strategies will likely occur as a result of the new summary report requirement. thus, by attempting to take steps forward through the addition of rule 26(a)(2)(c), courts may actually be taking a step back by not drawing clearer standards. iv. suggested framework a. taking into account the purposes of treating physicians' testimony because there have been conflicting opinions on the need to produce an expert report, now is the time to set the record straight on rule 26(a)(2)(b). when considering which system to adopt, the seventh circuit should consider the pw.poses of the testimony of treating physicians: they "are not retained for purposes of trial," and thus "(t]heir testimony is based upon their personal knowledge of the treatment of the patient and not in­ formation acquired from outside sources for the purpose of giving an opin­ ion in anticipation oftrial.'.209 treating physicians are not chosen as experts by their patients, but instead "are witnesses testifying to the facts of their 205. shea et al., supra note 201; beeber & sarig, supra note 192, at 130 ("although the amendment will imposes [sic] a new, albeit minor, obligation on non-retained experts, the rule might operate to relieve these experts in cases in which the court would otherwise be inclined to order a full report under rule 26(a)(2)(b)."). 206. beeber & sarig, supra note 192, at 130. 207. see generally pollard et al., supra note 200 (discussing the complexities created by this new requirement). 208. /d. 209. christopher dyer, treating physicians: fact witnesses or retained expert wit­ nesses in disguise? finding a place for treating physician opinions in the iowa discovery rules, 48 drake l. rev. 719, 729 (2000). 2012] treating physicians as witnesses 275 examination, diagnosis, and treatment of the patient "210 in conducting his or her duties as a doctor, a treating physician will establish an opinion based on his or her examination of the patient and will often opine as to the pa­ tient's future prognosis. 211 "these opinions are a necessary part of the treatment of the patient.'.zt2 thus, "[a ]fter all is said and done, most treating physicians are not re­ tained by parties as expert witnesses," and just because treating physicians may be considered experts due to their scientific knowledge "does not change this reality.'.213 there is a difference between those experts who are retained in anticipation of litigation and treating physicians, which may jus­ tify treating the two differently. "retained experts are tantamount to em­ ployees of the retaining party, whereas "[m]ost treating physicians ... are related to the party only by virtue of the historical accident of having treated the party's injuries.'.214 in addition, a treating physician's testimony is "of­ ten more relevant, material, and probative, than that of the retained expert who is not only paid for his testimony but often gleans it from a cold rec­ ord.'.2ts moreover, while there are potential prejudices for a party who is una­ ware of the extent of an expert's testimony, this is not often the case with a treating physician, and there are ways that patients can avoid causing any prejudice to opposing parties. ''the federal rules of civil procedure ap­ proved by congress do supply other mechanisms, besides formal reports, for extracting the views of an expert witness,'' and thus "sandbagging is not necessarily inevitable.''216 these mechanisms include a party's rule 26(a)(l)(a) disclosures ofwitnesses, fed. r. civ. p. 26(a)(l)(b)'s require­ ment of producing "all documents, electronically stored information, and tangible things that are in possession, custody, or control of the party and that the disclosing party may use to support its claims or defenses, unless solely for impeachment," depositions, individual document demands, and other discovery the court deems necessary and appropriate.217 even if these protections are not enough, a party may be sanctioned under rule 3 7 for failure to comply with any of the above, and "district courts are empowered to go above and beyond what the rules prescribe" if need be.218 210. /d. 211. id. 212. id. 213. id. at 738. 214. /d. at 738-39. 215. /d. at 739. 216. watson v. united states, 485 f.3d 1100, 1108 (loth cir. 2007). 217. id 218. id 276 indiana health law review [vol. 9:1 b. balancing test proposition the seventh circuit should enunciate a standard that would include balancing a number of factors against the interests ofboth parties. none of these factors are alone sufficient, and they all should be considered when deciding what type of witness the treating physician will be. treating physicians should not always have to be designated experts. there are situations in which treating physicians should remain fact wit­ nesses. when a treating physician's testimony is limited to uncontroversial issues such as a patient's injuries, and both parties will not experience any surprises or prejudice as a result of his or her testimony, then the doctor should be considered a lay witness. for instance, there are times when a treating physician may have learned the underlying facts from personal ob­ servation or experience,219 or everything is available in the "cold record," and a treating physician is simply testifying as to the records that have al­ ready been produced to the other side. situations such as these suggest that a treating physician should not suffer the burden of a summary report for such limited testimony. • courts should consider a number of factors to determine whether a treating physician is an expert who needs to produce a report versus a summary report. these should include: • did the physician ask to review medical records of anoth­ er health care provider in order to develop his opinion testimo­ ny concerning the appropriateness of the care and treatment of the provider?220 similarly, did the treating physician rely upon records, which were produced by his or her counsel or from any other person in order to establish his opinion?221 • did the treating physician provide a great deal of analysis exclusively for trial, and was he compensated for this work?222 • did the client's attorney refer the patient to the physician for treatment? • how was the physician compensated? was his or her compensation determined by their time spent preparing to tes­ tify or testifying at trial?223 • how long has the physician treated the patient? 219. robert e. larsen, navigating the federal trial§ 9:46 (2010 ed.). 220. kirkham v. societe air france, 236 f.r.d. 9, 12-13 (d.d.c. 2006). 22.1. id. 222. john k. rabiej, new areas of review by the advisory committee on civil rules, including rules 13, i5, 26(a)(2)(b), 48, and 62.1, and broader civil procedure projects, including time computation, summary judgment, and notice pleading, in ovil practice and litigation techniques in federal and state courts (all-aba course of study, 2007). 223. kirkham, 236 f.r.d. at 12-13. 2012] treating physicians as witnesses • what is expected to be the depth of the physician's testi­ mony? • was the injury considered by the treating physician known to the patient before the commencement oflitigation? • was the opposing party aware of the extent and scope of the treating physician's treatment? 277 the seventh circuit should generally adhere to the approach that seems to have been embraced by a growing number of courts, including numerous district courts located within the seventh circuit. the primary consideration of a court should be whether the proposed testimony was part of the treating physician's personal knowledge of the facts. then, the rest of the above factors should be considered on the balance of the circum­ stances to determine whether a full-blown expert report is necessary. suppose that an accident occurred where a plaintiff was injured and now sued the defendant for his injuries. if the treating physician were only to testify based upon his medical records and opinions, then courts should allow that treating physician to testify as to causation, prognosis, or perma­ nency of injury or disability without producing an expert report. however, if a treating physician bases his testimony upon outside information provid­ ed by others, courts could reasonably categorize the physician. as an expert witness. accordingly, the treating physician would be required to complete an expert report. by looking to the length of treatment, the date when treatment began, the date the lawsuit was filed, and the date when the pa ... tient became aware of his condition, courts may get a sense of whether this doctor was retained solely for the purposes of litigation. also, a patient that was referred to a physician by his attorney should also cause courts to raise an eyebrow because it is much more likely that doctor was retained as an expert witness for the purposes of the trial. a court should also inquire into the opposing party's knowledge of the treating physician before determining an expert report is required. accord­ ingly, if an opposing party is fully aware of the extent of a treating physi­ cian's testimony, there is less of a need for the production of an expert report. c. when treating physicians are designated experts needing to produce a summary report, what should be included? treating physicians will now likely be forced to produce a summary report even when they are only testifying to their own treatment and obser­ vations of plaintiff if current trends continue, and little guidance is offered as to what an acceptable summary report looks like under new rule 278 indiana healtii law review [vol. 9:1 26{a)(2)(c).224 a mandate requiring summary reports from all treating phy­ sicians is especially concerning, considering that the guidelines for com­ pleting a report are inadequate, thus forcing the parties to guess at what the court will consider acceptable. one judge in the southern district of indi­ ana has suggested that these analyses will be on a ''witness-by-witness ba­ sis,"225 but other district courts in the seventh circuit have thus far not provided significant assessments on the substance of the summary reports by treating physicians. the seventh circuit district courts should be mindful in crafting their own strategies under amended rule 26 that while the new summary re­ quirement eases the burden on those physicians who had previously been automatically required to complete an expert report, other treating physi­ cians who were not in districts that required reports are experiencing a new burden. hence, when determining what is required in this summary report, courts should err on the side of caution in favor of patients. treating physi­ cians are often vitally important to a patient's case and likely form the backbone of the evidence, and hence courts should be more lenient, particu­ larly when opposing parties are aware of the extent of a treating physician's opinions and testimony. moreover, it is more reasonable to allow patients to submit a broader summary report as opposed to a specific report that may subsequently limit the extent of that physician's testimony.226 opposing parties will have ac224. valentine v. csx transp., inc., no. 1:09-cv-01432-jms-mjd, 2011 u.s. dist. lexis 58813, at *10-11 (s.d. ind. may 10, 2011). 225. /d. at *13 n.l. 226. see in re yasmin & yaz ~irenone) mktg., no. 3:09-md-02100-drh-pmf, 2011 u.s. dist. lexis 116575, at *4-6 (s.d. til. oct. 7, 2011) ("[t]he facts the disclosing party is [sic] required to provide are not tied to the witness's opinions. instead, rule c re­ quires a summary of the }acts and opinions to which the witness is expected to testify.' clearly, pursuant to the plain language of rule c (and unlike the express requirement found in rule b), the disclosing party is not required to provide the facts upon which the non­ retained expert relied for his or her opinion. rather, rule c unambiguously states that the 'facts' and 'opinions' which must be provided are two distinct concepts. therefore, ... to satisfy fed. r. civ. p. 26(ax2xc) a party •.. need only disclose a summary of facts and a summary of opinions about which its otherwise non-reporting experts will be testifying. in that way, the requirements of this portion of rule 26 are much less than 26(ax2xb). even if one could suggest that the language in rule c is ambiguous, the recorded proceedings of the committee make it clear that the sqmdard of less disclosure (rather than more) is to be re­ quired by district courts in rule c disclosures."). c.f. crabbs v. wal-mart stores, inc., no. 4:09-cv-00519-raw, 2011 wl 499141 (s.d. iowa feb. 4, 20ll)(limiting a physical ther­ apist's testimony to "the subject matter, facts and opinions incorporated in his evaluation," which constituted his acceptable summary report). see also carrillo v. lowe's hiw, inc., no. 10cv1603-mma (cab), 2011 wl 2580666, at *3 (s.d. cal. june 29, 2011) (plain­ tifrs treating physicians may ... testify as percipient witnesses regarding the treatment they rendered to plaintifl: including the plaintiff's presentment of symptoms, their diagnoses, the treatment they provided plaintiff, and the medical bios incurred for their treatment . . . . [they] are, however, precluded from offering opinions as to causation, and the plaintifrs future medical condition, the reasonableness of the medical expenses incurred, the expenses for future medical treatment, and any other opinions beyond the treatment they rendered to 2012] treating physicians as witnesses 279 cess to the doctor's medical records, will be able to depose the treating phy­ sician, and thus will possess more than adequate notice of a treating physi­ cian's testimony. consequently, opposing parties are unlikely to face unfair prejudice in the wake of a broader type of report so long as they have fair notice of a doctor's opinion testimony and time to prepare for it. by employing a more liberal standard for the summary report re­ quirement, the seventh circuit can even the playing field between patients and opposing parties. treating physicians will be less burdened and less constricted, and opposing parties will still have sufficient notice which will help them avoid unfair prejudice. v. conclusion the need for a clear standard has been apparent since the 1993 rule 26 amendments, and with the addition of rule 26(b)(2)(c), the time is ripe to determine where treating physicians fall within the new schematic. above all, the seventh circuit lacks uniformity in the way it determines the necessity of an expert designation, an expert report requirement, and a summary report requirement. currently, where a treating physician belongs in rule 26 may depend on the district or even the individual judge assigned to the case. when considering whether to impose an expert report requirement, the foremost consideration of seventh circuit courts should be whether the doctor consulted records outside his or her scope of treatment in developing his or her testimony. the usual mark of a retained expert involves his or her use of other physicians' records or other outside information to develop his opinion. this standard is easier to interpret than the strategies of other courts. in addition, it will not be hard to utilize in seventh circuit courts because several courts have already implemented this standard. by addi­ tionally instituting the proposed balancing test, courts will be able to avoid requiring an expert report of those true treating physicians who consulted outside resources simply as a part of their treatment of the patient. determining the extent of the new summary report requirement will not be a simple process, but the seventh circuit should consider the burden that it imposes upon treating physicians and should adopt a broader ap­ proach to these reports unless unfair prejudice or surprise is likely to occur to an opposing party. if the history of the expert report requirement has taught us anything, it is the need for uniformity, and the seventh circuit should therefore adopt a single, clear standard, which leaves little room for manipulation by parties seeking to pass through quasi-loopholes. the issue of treating physicians has been lingering long enough, and plaintiff. such testimony was subject to the disclosure requirements of rule 26(ax2)(c), and having failed to provide defendant with a summary of those opinions and the facts sup­ porting those opinions, defendant would be unduly prejudiced to allow such testimony at trial or in any other proceeding."). 280 indiana health law review [vol. 9:1 the adoption of rule 26(b)(2)(c) has forced the issue. it is time to find a proper·place for treating physicians in the seventh circuit. hcqia does not provide adequate due process protection, improve healthcare quality and is outdated under obama care hcqia does not provide adequate due process protection, improve healthcare quality and is outdated under "obama care" paul k. ho* i. introduction. ............................... ..... 304 ii. peer review background and statutes .... ...... 307 a. history of quality oversight in american hospitals................................. 308 b. hcqia historical background ................. 309 c the statutes involved. ............ ............ 311 1. health care quality improvement act ("hcql4") 311 2. npdb.. ..................................... 312 3. indiana peer review act ............. ....... 313 d. description of the hospital peer review process...... 313 e. illustrative cases under hcqia........... ..... 315 iii. hcqia does not adequately protect the constitutional property and liberty rights of physicians undergoing peer review....................... 318 a. medical licenses and medical staff privileges are protected liberty and property interests for physicians. ............................. .... 318 b. the 'presumption of imm unity"and the 'reasonable belief' standard under hcqia creates an almost insurmountable barrier for defense of targeted physician ' due process rights ................ 320 c vague standards for judging physician competence further compounds the problem ............... 324 1. arbitrary standards and their capricious application .......................... ..... 325 2. are clear standards feasible? ............... 325 d. the punishment does not fit the crime.................. 327 j.d. candidate, 2014, indiana university robert h. mckinney school of law, indianapolis, indiana; m.d., 1977, new york medical college, new york, new york; m.s., 1974, mailman school of public health, columbia university, new york, new york; b.a., 1973, columbia college, columbia university, new york, new york. indiana health law review iv. hcqia does not effectively improve health care quality and is outdated in today's health care environment ...................................... 330 a. whistle blowers are at risk of sanctioning under hcqia ............................ ....... 330 b. customary care is perpetuated under hcqia......... 332 c. present standards under hcqia create risks for hospitals and peer review committees ...... .... 334 d. modern health care systems and "obama care" have made hcqia outdated........ .......... 337 v. proposed solutions ..................... 339 a. improve due process under hcqia to comport with constitutional standards ......... ........ 339 b. use a better-defined standard for judging physician competence ................................ 344 c. rely on a systems aproach to address medical errors and improve health care......................... 345 d. use an independent board for peer review ............. 346 vi. conclusion ...................................... 346 i. introduction dr. thomas wieters, was a surgeon practicing at roper hospital, south carolina, for more than ten years.' a decorated vietnam veteran, he had strong convictions about putting patient care and safety first.2 when the once reputable and storied hospital changed administrations, he noticed the quality of patient care declining, such as medication errors and poor patient monitoring, sometimes with catastrophic consequences. 3 wieters wrote complaints to the administration and requested incident reports be placed in patient charts. displeased, the hospital's 1 steve twedt, the cost of courage: when right can be wrong, pittsburgh post-gazette, oct. 27, 2003, http://www.postgazette.com/stories/news/us/the-cost-of-courage-when-right-can-bewrong-520672/ 2 id. 3 id. 304 vol. 11:1 2014 hcqia does not provide adequate due process administration labeled him disruptive and ordered a peer review investigation on him. 4 wieters was summarily suspended without a hearing, in spite of the department of surgery committee finding that his behavior was explainable and that there were no quality issues in his patient care.5 many colleagues and nurses on staff signed petitions calling for his reinstatement, but to no avail.6 his suspension was reported to the national physician's data bank ("npdb") which has made it impossible for him to work at any major hospital, either locally or in another state.7 in his resulting lawsuit, the united states district court ruled against him, citing that the hospital's immunity under the health care quality improvement act of 1986 ("hcqia") gave it considerable discretion in matters of physician discipline.8 the fourth circuit later affirmed this ruling.9 wieters was subsequently ordered to pay $357,000 in attorneys' fees for the hospital.'0 this judgment, along with his inability to establish a substantial practice due to the npdb listing, has caused him to declare personal bankruptcy and has ruined his career.11 it was of little consolation that his complaints led to an investigation of the hospital by the state inspectors several months after his suspension where issues involving "serious threats to the health and safety of patients" were found. 12 dr. wieters' story is just one example of how peer review under hcqia has led to the unfair treatment of targeted physicians and has not served as an effective tool in improving the quality of health care. peer review is a process where a physician's patient-care and professional behavior in the hospital setting is reviewed 4 id. 5 id. 6 id. 7 id. 8 wieters v. roper hosp., inc., 58 f. app'x 40 (4th cir. 2003). 9 id. at 47. 10 twedt, supra note 1. 11 id. 12 id. 305 indiana health law review by a group of his peers. 13 an adverse decision by the peer review committee can result in limitation or loss of a physician's hospital privileges and listing on the national physician's data bank.14 these types of actions can severely damage a physician's career and result in loss of livelihood. congress enacted the hcqia to provide immunity to peer review committee members and the hospital and, thus, encourage peer review in hopes of improving the quality of health care.'5 however, in the private hospital setting, the lack of mandatory due process procedures and poorly defined standards have led to abuse of the peer review process. 16 the current practice of physician peer review in the private hospital setting under the hcqia shield of immunity is not effective in regulating physician behavior, assuring quality care, or lowering health care cost. additionally, as the institution responsible for review, there are further risks to the hospital in terms of compliance and possible challenges under the false claims act.17 section ii of this article will discuss the peer review and its history in american private hospitals, the origin and elements of hcqia, and recent pertinent case law. section iii will discuss the negative impact hcqia has on both the peer reviewed and reviewing physicians as well as the host hospital. section iv will discuss how hcqia is not meeting 13 katherine van tassel, hospital peer review standards and due process: moving from tort doctrine toward contract principles based on clinical practice guidelines, 36 seton hall l. rev. 1179, 1190 (2006). 14 id. at 2000. 15 see generally eleanor d kinney, hospital peer review of physicians: does statutory 1mm unity risk of unwarranted professional injury? 13 mich. st. l.j. of med. and l. 57, 79 (2009). 16 id. at 60 (citing steve twedt, the cost of courage: how the tables turn on doctors, pittsburgh post gazette, oct. 26, 2003, available at www.postgazette.com/pg/03299/234499.stm (the article is the first article in a series on different occasions of so-called sham peer review and actions against "disruptive" physicians around the country)). 17 bna insights: health law resource center, quality of care, medical necessity, and the peer review process: a compliance risk that every hospital should understand, (sept. 27, 2012), http://www.bna.com. 306 vol. 11:1 2014 hcqia does not provide adequate due process its intended goal of improving patient care and poses risks for all parties involved in the peer review process. section v will discuss potential legislative, judicial and health system remedies to better reach the end goal of balancing patient protection, quality care, the independent interest of hospitals, and the property and liberty interests of physicians. ii. peer review background and statues entry into the profession of medicine is regulated through state licensure boards, which are comprised mostly of physicians. in the united states, physicians practicing in hospitals are organized into a medical staff with medical staff bylaws based on state licensure law and private accreditation standards.18 credentialing and peer review of physicians by hospitals is the primary method of regulating physicians who practice in hospitals, and it is required by accrediting bodies such as the joint commission,19 states as a condition of hospital licensure, 20 as well as medicare and medicaid programs. 21 18 kinney, supra note 15, at 60 (citing paul van grunsven, the physician and state regulations §3.01, health care law desk reference 37-38 (alison barnes, steve fatum, robert gatter & kevin gibson eds., 2001)). 14 id. at 60-61 ("the... (jcaho) is the primary accrediting body for allopathic hospitals in the united states. as such, the jcaho establishes standards for the organization and operation of the hospital medical staff.") (citing joint commission, comprehensive accreditation manual for hospitals: the official handbook, standard ms 1.20-5.10 (2007)). (the jcaho sets standards for medical staff peer review) (see kathy matzka, compliance guide to the jcaho medical staff standards (2006)). 20 states also require that hospitals have medical staffs that conduct peer review as a condition of licensure. see timothy s. jost, the joint commission on accreditation of hospitals: private regulation of health care and the public interest, 24 b.c. l. rev. 835, 841-49 (1983). 21 the medicare and medicaid programs require that hospitals have medical staffs and engage in peer review in order to participate in these programs. 42 c.f.r. § 482.22 (2008). 307 indiana health law review a. history of quality oversight in american hospitals patient care was predominantly outpatient based (either in the physician's office or the patient's home) before the early 1900s. prior to that time, hospitals were perceived to be poorly run, considered mainly as charitable institutions for the poor and insane, and to be avoided if possible due to the periodic bouts of institutional infections. 22 however, with the advances in medicine, hospitals and hospital medical staff appointments began to play an increasingly important role in surgical practices and specialization. 2 3 the number of hospitals grew at a rapid rate, so that by 1930 there were 6719 hospitals. the american college of surgeons ("acs") was formed in 1913 to help standardize hospital care. the acs established the "minimum standard" for safety and performance along with the hospital standardization program ("hsp") to monitor and refine this "minimum standard". the "minimum standard" proposed an organized medical staff to adopt rules and policies for the professional work of the hospital. this led to standardization and minimum requirements for admission to more than 90% of medical staffs by 1935. the joint commission on accreditation of hospitals ("jcah") was formed in 1951 by the joint efforts of the acs, the american hospital association, the american medical association, the american college of physicians and the canadian medical association. 24 in 1952 the hsp was transferred to the jcah which later was later renamed the joint commission on accreditation of healthcare organizations ("jcaho", also known as "the joint commission" or "tjc"). the joint commission is a private, non-profit organization and following its guidelines is optional, however, most hospitals strive to maintain jcaho compliance and accreditation in order to qualify for state medicare payments and to meet many state licensure requirements. jcaho continues to require that all hospitals have an independent, selfgoverning medical staff that is responsible for and 22 van tassel, supra note 13, at 1186-89. 23 id. 24 id. 308 vol. 11:1 2014 hcqia does not provide adequate due process accountable to hospital governing board for the quality of medical care provided by medical staff members. 25 a physician's ability to treat patients at a hospital is contingent on being a member of the medical staff. a physician's "clinical privileges" at a hospital defines the scope of patient treatment he may provide and this is decided by the medical staff, based on the physician's education, license, experience, training, competence, judgment and health.2 6 the medical staff is required to have its own bylaws which establish, among other things: (1) a medical staff executive committee and define its functions; (2) "fairhearing and appellate review mechanisms for medical staff members and other individuals holding clinical privileges"; (3) "mechanisms for corrective action, including indications and procedures for automatic and summary suspension of an individual's medical staff membership or clinical privileges"; (4) "the medical staffs organization, including categories of medical staff membership"; (5) "[a] mechanism designed to provide for effective communication among the medical staff, hospital administration, and governing body"; and (6) "medical staff representation and participation in any hospital deliberation affecting the discharge of medical staff responsibilities."27 b. hcqia historical background a widely publicized supreme court case involving dr. timothy patrick, a surgeon at the only hospital in the small city of astoria, oregon, helped set the stage for hcqia. dr. patrick had decided to set up his own practice, rather than join the main group at the hospital. his competitors initiated peer review proceedings against him and he resigned his staff privileges rather than have them 25 id. 26 id. 27 joint comm'n on accreditation of healthcare orgs., comprehensive accreditation manual for hospitals: the official handbook p ms.1, at ms-2, pp ms.2.3 to ms.2.3.8, at ms-3 to ms-4. (1999) [hereinafter camh]. 309 indiana health law review terminated. 28 a legal battle ensued and dr. patrick was awarded a $2.28 million verdict in a federal antitrust suit, which was reversed by the united states court of appeals for the ninth circuit.29 in 1988, the united states supreme court reversed the ninth circuit ruling in patrick v. burget, and reinstated the verdict holding that medical peer-review associated activities in this case did not meet the requirements for a state action exemption from federal antitrust liability.30 this case and the associated events saw an increase in antitrust suits against hospitals and peer review physicians, which lead to medical and hospital associations to lobby congress for immunity under federal antitrust laws. 31 during the hcqia legislative process, peer review immunity from antitrust laws was vigorously opposed by the federal trade commission; house oversight committees for the federal antitrust laws; and the department of justice, who wrote that antitrust review would encourage quality health care by preventing costeffective and innovative doctors from being excluded from the market.32 however, the hcqia and the npdb were established when congress found the need to control (1) the increasing occurrence of medical malpractice and improve the quality of medical care . . . (2) [and] the ability of incompetent physicians to move from state to state without disclosure [and a need for] (3) effective professional peer review. (4) [without the] the threat of private money damage liability, including treble damage liability 28 patrick v burget, 800 f.2d 1498 (9th cir. 1986). 29 id. 30 486 u.s. 94, 105-06 (1988), rev'g 800 f.2d 1498, (9th cir. 1986). 31 kinney, supra note 15, at 64 (citing john k. iglehart, congress moves to bolster peer review: the health care quality improvement act of 1986, 316 new eng. j. med. 960 (1987); see generally health care quality improvement act of 1986: a legislative history of pub. law no. 99-660 (bernard d. reams ed., 1990)). 32 id. 310 vol. 11:1 2014 hcqia does not provide adequate due process 311 under federal antitrust law . . .33 c. the statutes involved the peer review process is governed by both federal and state statutes. 1. health care quality improvement act ("hcqia") 3 for peer review body members, staff, contractors, and informants to obtain qualified statutory immunity from federal antitrust laws as well as other federal and state legal actions35 42 u.s.c. § 11112(a) states: for purposes of the protection set forth in section 11111(a) of this title, a professional review action must be taken-(1) in the reasonable belief that the action was in the furtherance of quality healthcare, (2) after a reasonable effort to obtain the facts of the matter, (3) after adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances, and (4) in the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain facts and after meeting the requirement of paragraph (3). a professional review action shall be presumed to have met the preceding standards necessary for the protection set out in section 11111(a) of 33 42 u.s.c. § 11101 (2013). 34 42 u.s.c. § 11101-11152 (2013). 35 excepted are actions by state attorneys general (42 u.s.c. § 11111(a)(1)(d) (2013); 15 u.s.c. § 15c (2013)) and for violation of federal rights laws (42 u.s.c. § 11111(a)(1)(d) (2013)). indiana health law review this title unless the presumption is rebutted by a preponderance of the evidence.36 subsection 11112(b) then goes to describe adequate notice and hearing standards but ends the subsection with: "a professional review body's failure to meet the conditions described in this subsection shall not, in itself, constitute failure to meet the standards of subsection (a)(3)."37 thus, although the due process requirements meet the constitutionally mandated standards set in goldberg v. kelly,38 this last provision, by making the requirements optional, has allowed courts to overlook the procedural elements of the peer review protections in considering immunity and effectively eviscerate the due process protections in § 11112(b).39 2. npdb due to concerns about incompetent physicians moving to other parts of the country and restablishing practices without disclosure of previous censures of their performance, congress, through hcqia, authorized the establishment of the national practitioner databank ("npdb"). npdb is maintained by the federal government and most malpractice judgments and settlements and disciplinary actions by hospital peer review committees must be reported to it.40 if a physician is reported to the npdb he has the option to appeal to the secretary of health and human services on the grounds that npdb report is inaccurate or on technical grounds: 41 however, less than 5% of these appeals are successful. 42 36 42 u.s.c. § 11112 (2013). 37 42 u.s.c. § 11112(b) (2013). 38 397 u.s. 254, 255, 262-63 (1970). 39 kinney, supra note 15, at 66. 40 42 u.s.c. § 11101-11115; 42 u.s.c. § 11131-11153 (2013). 41 45 c.f.r. § 60.16 (2013). 42 michael j panella, the legal ramifications under the health care quality improvement act of physicians labeled disruptive for advocating patient quality of care issues, 24 j.l. & com. 281, 288 312 vol. 11:1 2014 hcqia does not provide adequate due process 3. indiana peer review act many states including indiana have further refined hcqia protection. the indiana peer review act provides absolute immunity for civil liability for medical staff peer review committee members.43 indiana's due process protections for the accused physician allow her (a) to see any records accumulated by a peer review committee pertaining to the provider's personal practice. (b) the opportunity to appear before the peer review committee with adequate representation to offer rebuttal information .[which] (c) shall be a part of the record. 44 indiana also specifically excludes from membership on the peer review committee a physician who is in direct economic competition with the targeted physician and provides for committee members outside of the medical staff.4 5 d. description of the hospital peer review process the quality of patient care in the united states is monitored through the state medical malpractice system, the state licensure system, and the hospital peer review system. 46 the state systems are public and provide due process to physician defendants prior to providing a negative report to the npdb. the hospital peer review, aside from government-run hospitals such as a veterans administration ("va") hospital, is private and there is no (2005) (citing steve twedt, a negative data bank listing isn't easy to erase, pittsburgh post-gazette, oct. 27, 2003, http://www.postgazette.com/pg/03300/234532.stm). 43 ind. code § 16-21-2-8 (2013). 44 ind. code 34-30-15-4 (2013) 45 ind. code 34-30-15-5 (2013) 46 kinney, supra note 15, at 79. 313 indiana health law review obligation to provide physicians with due process protections during the hearing process. 47 the hospital medical staff, through either an appointed or elected committee is obligated to ensure the quality of care and treatment provided by practioners it has approved and previleged through the credentialling process. 48 a number of events could trigger a peer review process and potentially result in the imposition of formal sanctions. these events include accusations of substandard clinical competence, physical or mental impairment, disruptive behavior, and loss of license or malpractice insurance, or violations of the medical staff bylaws. 49 in these instances, a peer review process which generally involves investigations and hearings based on the institution's bylaws would be started on the accused physician. if the allegations are substantiated, the physician can be penalized in a variety of ways, including termination of the physician's hospital staff privileges. any adverse actions that affect the privileges of a physician more than 30 days must be reported to the state licensure board, which ultimately must report the action to the npdb.50 hospitals are required to query the npdb data bank prior to granting medical staff privileges to a physician.6 1 once a physician has had a decredentialling listing by the npdb, it is generally felt that he would have significant difficulties in obtaining further staff privileges at any hospital. the inability to obtain hospital privileges can seriously curtail a physician's ability to practice medicine, even with a valid state medical license. 52 47 katherine van tassel, blacklisted. the constitutionality of the federal system for publishing reports of "bad" doctors in the national practitioner data bank, 33 cardozo l. rev. 2031, 2052-2053 (2012). 48 camh, supra note 27, at p ms.1, at ms-2 (2005). (the credentialing process involved gathering, verifying, and evaluating the physician's training, competence and record, either on initial application for staff privileges or on renewal. clinical privileges, which define a physician's scope of practice, are assigned based on the evaluation.). 49 van tassel, supra note 13, at 1191. 50 id. 51 id. 52 van tassel, supra note 47, at 2053-54. 314 vol. 11: 1 2014 hcqia does not provide adequate due process bolstering the list that could trigger peer review and possible adverse action was the "sentinel events alert," issued by jcaho in july 2008, which expanded the list that could trigger peer review and possible adverse action. the "alert" highlighted the impact of disruptive behavior on patient safety and set new standards for institutions to create a code of conduct that defines acceptable and unacceptable behaviors and a formal process for managing unacceptable behavior.53 if the peer review committee follows the hcqia standards for "adequate notice" and "fair" process, the censured physician is unable to sue for damages but can still sue for injunctive and other types of equitable relief.54 however, these legal challenges generally fail due to the vague standards and judicial deference of courts in favor of hospital administrations.5 5 e. illustrative cases under hcqia several cases illustrate the potential for abuse and the frustrations experienced by the targeted physicians under hcqia. dr. poliner was an independent interventional cardiologist who had been in practice for 20 years with a clean record. he was in competition with the major cardiology group at presbyterian hospital. on may 14, 1998, after a preliminary peer review, he was presented with the option of signing a temporary abeyance of his privileges or face summary suspension due to one missed diagnosis from a cardiac catheterization case and some other minor patient care issues raised by his competitor 53 joint commission on the accreditation of healthcare organizations, sentinel event alert: behaviors that undermine a culture of safety, (july 9, 2008), available at http://www.jointcommission.org/assets/1/18/sea_40.pdf 54 van tassel, supra note 13, at 1197. (many state statues provide broader immunity for the hosptial and peer review participants, but unlike hcqia, in most cases, state immunity will not provide protection from federal antitrust actions. see islami v. covenant med. ctr., 822 f. supp. 1361, 1379-80 (n.d. iowa 1992)). 55 id. at 1204-10. 315 indiana health law review cardiologists. he was not given the option of seeking legal counsel or defending his care prior to signing. his privileges were ultimately restored several months later. he subsequently sued the peer reviewers and the hospital and in 2004 a texas jury awarded him $33 million in damages.5 6 this judgment was later reversed by the 5th circuit court of appeals, based on hcqia's articulated "reasonable belief' standard and that congress's grant of "limited immunity from suits for money damages to participants in professional peer review actions"57 , and there is a "presumption that a professional review [action] meets the standards for immunity, unless the presumption is rebutted by a preponderance of the evidence"58 and that the evaluation of evil intent or anticompetitive motives is an objective one, therefore "subjective [anticompetitive] motivations [do not] overcome hcqia immunity".5 9 dr. ulrich had been on the staff of laguna honda hospital for nearly 10 years. when the hospital began to lay off physicians for budgetary reasons, he openly criticized this action,60 but immediately found himself the target of a peer review action. 61 he resigned his staff membership, rather than face peer review. when he found that that resigning in the face of a pending peer review action was reportable to the npdb, he tried to rescind his resignation; the hospital refused and reported him to the npdb anyway. 62 he subsequently sued the hospital and peer review members based on violating of his first amendment rights of free speech and fourteenth amendment right to due process.63 a jury later awarded him $4.3 million.64 56 poliner v. tex. health sys.537 f.3d 368 (5th cir. 2008) 57 id. at 376. 58 id. at 377. 59 id. at 380. 60 ulrich v. city and county of s.f. 308 f.3d 968, 986 (9th cir. 2002) 61 id. 62 id. 63 id. 64 ulrich v. city and county of s.f., no. c-99-05003-teh, 2004 wl 1635542, *1 (n.d. cal. july 12, 2004). 316 vol. 11-1 2014 hcqia does not provide adequate due process dr. kenneth clark was a physiatrist at a reno hospital. when the hospital discovered that he had written letters of complaint about certain hospital policies and substandard care to champus and to jcaho, it instituted peer review proceedings on him and terminated his privileges based on disruptive conduct. 65 in the legal action by dr. clark against the hospital that ensued, the district court granted the hospital summary judgment on the basis of hcqia immunity,6 6 a decision which the nevada supreme court later reversed holding that the hospital was not immune because the revocation of dr. clark's staff privileges was not made with the reasonable belief that it was in furtherance of quality healthcare67 and that whistle blowing is conduct protected as a matter of public policy.68 dr. poliner's case illustrates the difficulty of piercing the shield of immunity afforded by hcqia and its potential abuse by those in a position of power in the private hospital setting. the cases of drs ulrich and clark were unusual in that the censured physicians were successful, but nevertheless illustrate the potential difficulties that a physician speaking out against hospital policies can encounter. the potential for abuse makes the peer review a tool for bullying and potentially defeats the goal of better patient safety and improved health care. physicians who perceive the process as unfair may refrain from complaint about the quality of care issues or disclosing a colleague's insufficiencies. 65 clark v. columbia/hca info. servs, inc., 25 p.3d 215, 219 (nev. 2001). 66 id. 67 id. at 220. 68 id. 317 indiana health law review iii. hcqia does not adequately protect the constitutional property and liberty rights of physicians undergoing peer review a. medical licenses and medical staff privileges are protected liberty and property interests for physicians the fourteenth amendment protects an individual's protected liberty and property interests from state deprivation without procedural due process. 69 a two step inquiry is used to evaluate a due process claim: 1) whether the state has interfered with a protected liberty or property interest and 2) whether the procedures "attendant upon that deprivation were constitutionally sufficient."70 a protected liberty or property interest is one that is ''recognized and protected by state law"; therefore a physician's medical license, which is issued by the state, is a protected property interest. 71 whether the procedures used to deprive those interests were constitutionally sufficient is measured by the three-part test of mathews v eldridge first, the private interest that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute procedural safeguards; and finally, the government's interest, including the function involved and the fiscal and administrative burdens that the 69 chudacoff v. univ. med. ctr of s. nev., 609 f. supp. 2d 1163, 1172 (d. nev. 2009) (citing bd. of regents of state colls. v. roth, 408 u.s. 564, 569 (1972)). 70 id. (citing humphries v. cnty of l. a., 554 f.3d 1170, 1184-85 (9th cir. 2009) (quoting ky. dep't of corr. v. thompson, 490 u.s. 454, 460 (1989)). 71 id. (finding that a state-issued driver's license may not be withdrawn without affording due process (citing paul v. davis, 424 u.s. 693, 710-11 (1976))). 318 vol. 11-1 2014 hcqia does not provide adequate due process additional or substitute procedural requirement would entail.72 professor van tassel has advanced the constitutionality argument that the private hospital peer review process that leads to the listing of physicians on the npdb fails to protect the property and liberty rights of targeted physicians. 73 besides a property interest in her medical license and many states also acknowledge that medical staff privileges standing alone are a property right because loss of staff privileges greatly limits a physician's ability to practice medicine and use her state granted medical license. 74 this is illustrated most clearly in the case of a surgeon who has her privileges terminated at the only hospital in town.75 the termination constitutes a negative peer review, which would have to be reported to the npdb. listing on the npdb could have a career ending effect on the doctor (dr. ullrich's case is an example).76 a negative peer review could also trigger an investigation by the state licensing board and cascade of other events.77 physicians also have a liberty interest in their reputation.7 8 when the federally run npdb sends negative peer reports to a hospital or other health care entity, the state action threshold has been crossed and this give rise to constitutional rights.7 9 due process as measured by the three part test of matthew v eldridge is not available as part of the peer review process.80 thus listing on the npdb unconstitutionally impacts the property and liberty rights of 72 mathews v. eldridge, 424 u.s. 319, 335 (1976). 73 van tassel, supra note 47, at 2033, 2063. 74 id. at 2057-58. 75 id. 76 id. at 2059-60; see also supra note 60 and accompanying text. 77 van tassel, supra note 47, at 2061-62. 7 id. at 2063f. three supreme court cases that support this argument are wisconsin v. constantineau, 400 u.s. 433 (1971); goss v. lopez, 419 u.s. 565 (1975); and paul v. davis, 424 u.s. 693 (1976). 79 van tassel, supra note 47, at 2033, 2062. 80 id. at 2033. 319 indiana health law review targeted physicians because of the lack of due process protection in the peer review process. 81 b. the" presumption of lmm unity" and the" reasonable belief' standard under hcqia creates an almost insurmountable barrier for defense of targeted physician's due process rights in examining the judicial review of adverse peer actions, it appears that although the courts have attempted to strike a balance between the interests of the physician, the hospital, and the public, court decisions have decidedly been in favor of the interests of the public and the hospital by providing a high level of deference to hospital's decisions. "human lives are at stake, and the governing board must be given discretion in its selection so that it can have confidence in the competence and moral commitment of its staff. the evaluation of professional proficiency of doctors is best left to the specialized expertise of their peers, subject only to limited judicial surveillance." 82 courts have generally deferred the factual evaluation of medical competence to the hospital peer review process, and have been more willing to review adverse peer outcomes to ensure that the hospital treated the physician with fundamental fairness and provided appropriate procedural due process. for governmental institutions, this protection has its basis in the constitution, and for private hospitals the due process review is based on contract as stipulated by the medical staff bylaws, fiduciary duty, common law fairness, or statute.083 however, an analysis of physician 81 id. at 2033, 2062. 82 van tassel, supra note 13, at 1201 (quoting sosa v. bd. of managers of the val verde mem'l hosp., 437 f.2d 173, 177 (5th cir. 1971)). 83 id. at 1202 (citing craig w. dallon, understanding judicial review of hospitals' physician credentialing and peer review decisions, 73 temp. l. rev. 597, 678 (2000)). vol. 11:1320 2014 hcqia does not provide adequate due process law suits challenging peer review decisions, 2003-2007 showed decisions were predominately in favor of the hospital and committee. 84 reviewing courts have almost exclusively upheld the presumption of immunity for the hospital and peer review committee members based on the following85 : 1) a reasonable belief that decision was in furtherance of quality care. 2) the burden of proof by plaintiff (targeted physician) is preponderance of the evidence.86 3) hcqia does not require that decision has to be correct, and only a reasonable effort to obtain the facts. 4) courts were generally reluctant to enforce strict due process standards. 5) bad faith is irrelevant to hcqia claims (especially if "breaches of quality were demonstrated"). 6) many mistakes and irregularities by the peer review committees were accepted by the courts.8 7 in fact, judicial review is not permitted for the merits of privilege decisions in most states; however, the courts may assess whether the hospital has followed hospital bylaw procedural requirements in its decisions concerning privileges. but courts will become involved for claims based on gender or race discrimination, penalizing a physician for whistle blowing, or other tortuous acts. therefore, except for certain exceptions of improper application of review standards, whistle blowing activity, and constitutional 84 kinney, supra note 15, at 74-75. 85 id. at 69f. 86 id. at 69 ("[in only 2 cases have federal courts reversed an order of summary judgment based on immunity because the physician demonstrated by a preponderance of the evidence that the board failed to give appropriate fair notice and procedures in accordance with § 11112(a)(3)." (quoting clarke v. columbia/hca info. serv., inc., 25 p.3d 215, 223 (nev. 2001))). 87 id. at 71 (citing meyer v. sunrise hosp., 22 p.3d 1142, 1153-54 (nev. 2001). the meyer v. sunrise hospital ruling upheld the hcqia immunity for a hospital that terminated a physician with record of high quality care due to a single incident, although a death. a concurring justice stated that hcqia can be used "not to improve the quality of medical care, but to leave a doctor who was unfairly treated without any viable remedy. . . unfortunately, this may leave the hospitals and review board members free to abuse the process for their own purposes." see supra poliner case as an example of the difficulty of piercing the shield of immunity provided by hcqia. 321 indiana health law review violations depending on the jurisdiction, courts have been reluctant to find a hospital liable for privilege decisions. given the broad presumption of immunity for a hospital's peer review, federal courts have found mostly in favor of hospitals and peer review members.88 legal scholars, the physician community as well as the media have expressed concerns about the antitrust immunity afforded peer review under hcqia as well as associated abuses. 89 only in the most flagrant improper application of review standards has hcqia immunity been successfully challenged as illustrated by two cases. in brown v. presbyterian healthcare serv., 101 f.3d 1324 (10th cir. 1996), the court held that review of only two patient charts prior to revoking obstetrical privileges in a peer review action did not meet the reasonable effort to obtain the facts of the matter standard, thus the hospital and review board members were not entitled to hcqia immunity. 90 in islami v. covenant med. ctr., the court held that the hospital peer review board breached its contract by not following procedures listed in bylaws, and thus not meeting the fair notice and hearing procedure standard under the hcqia where a surgeon had privileges immediately suspended.9 1 88 panella, supra note 42, at 287-88; see also clark columbia /hca info. servs., 25 p.3d 215, 222 (nev. 2001) (adverse peer review for disruptive behavior involving only whistle blowing conduct is not shielded under hcqia immunity). 89 kinney, supra note 15, at 77; see also gerald weiss, is peer review worth saving? 82 med. econ. 46 (2005); tanya albert & damon adams, peer review under fire: real problems or trumped-up accusations? amnews (oct. 10, 2005), available at http://www.amaassn.org/amednews/2005/10/10/prsalo10.htm.) 90 panella, supra note 42, at 289 (citing brown v. presbyterian healthcare serv., 101 f.3d 1324 (10th cir. 1996). 91 id. at 289-90 (citing islami v. covenant med. ctr., 822 f. supp. 1361, 1365 (n.d. iowa 1992) (in islami the surgeon asserted his right under the bylaws to exclude competitors from the reviewing committee and right to provide additional evidence and testimony, but the court denied summary judgment for the hospital and remanded the case for a jury trial)). 322 vol. 11:1 2014 hcqia does not provide adequate due process one might argue that most physician adverse peer reviews are warranted, and only the very publicized or successfully litigated appear as abusive or malicious. undoubtedly, incompetent and badly behaved physicians are a threat to patient safety and the smooth operation of a hospital, and that the legal immunity is needed to protect the peer reviewers. however, the process of regulation of physician conduct should operate in a fair manner with respect to physicians and also protecting the public. a system that does not cause unnecessary injury to any of the parties involved can only prove beneficial in the long run. courts have also ruled differently on constitutional challenges to hcqia. the court in ulrich v. city and county of san francisco stipulated that a 14th amendment claim of liberty interest of future employment was potentially affected when the hospital filed a npdb report, due to the physician resigning while under peer review investigation, and remanded for lower court to determine if npdb listing was stigmatizing and thus could affect future employment.92 a different approach taken by 4th circuit in freilich v. upper chesapeake health, inc. where it denied a physician's constitutional challenges to hcqia immunity in an adverse peer review decision and held there was no due process or equal protection violation by using rational basis review (hcqia did not burden any fundamental right or draw distinctions based on suspect criteria). the court found that hcqia was rationally related to a legitimate government purpose of quality improvement of the nation's health care system and upheld the reasonable standard that governs the grant of peer review immunity stating that it was not unconstitutionally vague. furthermore, the court held the hcqia did not violate the tenth amendment as congress had authority under the commerce clause to enact statues concerning physician peer review.93 92 id. at 292 (citing ulrich v. city of san francisco, 308 f.3d 968, 986 (9th cir. 2002)). 93 id. at 297 (citing freilich v. upper chesapeake health, inc., 313 f.3d 205, 210 (4th cir. 2002)). 323 indiana health law review the argument can been put forth that in the private institution setting, contract principles apply and fair procedure, not strict due process is necessary.94 however (applying the three prong test of mathews v eldridge), the affected physician's liberty interest is great and without adequate due process, the risk of error and injury is great, and although the government has an interest in improving health care quality, it should also have an interest in protecting the liberty interests of all of its citizens. since mandating the additional safeguard of due process in peer review is a minimal burden, as it is already mandated in government hospitals, it should also be mandated in the private hospital setting. c. vague standards for judging physician competence further compounds the problem in spite of varying degrees of enforcement, most courts are in accord with the procedural due process protections that should be offered to a physician (right to representation, right to have a record made of proceedings, right to examine witnesses and present evidence). however, there is disagreement on the hcqia requirement of "fairness of standards" in peer review. some courts feel that specific criteria can be objectively applied; others feel that objective criteria are not possible.95 standards for judging physican competence have been hard to define, by both hospitals and courts. vague standards not only violate an essential element of due process but have negative implications for all stake holders in the peer review process by: 1) not giving fair notice of expected competency or conduct to the targeted physician, 2) increasing the risk of arbitrary decisions by the peer review committee, thus also increasing the chance of their loss of immunity, 3) and making meaningful judicial review difficult.9 6 many courts have opined that due to the rapid 94 kinney, supra note 15, at 70 (citing goodstein v. cedars-sinai med. ctr., 66 cal. app. 4th 1257 (1998)). 95 van tassel, supra note 13, at 1203-04. 96 id. at 1205-06. 324 vol. 11:1 2014 hcqia does not provide adequate due process advances in medical care, it would be hard to provide objective criteria for judging physician competence, and that these challenges to vagueness have survived in the context of malpractice and medical licensure proceedings. 97 the difficulty with defining competency standards may be the reason courts have focused on enforcing the mechanical portion of due process protections in the peer review setting. but vague standards in the peer review setting haves greater potential for causing harm than in a malpractice action. in the later, the decisions makers are judges, juries, and administrative officials without prior dealings with the targeted physician, whereas in the former, the peer review committee is highly likely to be composed of in-house persons with prior and probably future personal and economic dealings with the targeted physician and who may be influenced by the local hospital politics.98 1. arbitrary standards and their capricious application. one extreme example of the use of arbitrary standards and their capricious application is illustrated in wyatt where the california court of appeals held that a hospital board's requirement that physicians or surgeons admitted to the medical staff are to be those with the "best possible care and professional skill" as judged by the board, set standards which left too much to the whim and caprice of the board to exclude applicants.99 courts, however, have failed to state how to create clearly articulated standards. 100 2. are clear standards feasible? the court in jackson articulated what many courts feel is a very difficult task of setting standards for measuring physician competence: 97 id. at 1184-85. 98 id. 9 wyatt v. tahoe forest hosp. dist., 345 p.2d 93, 97 (cal. ct. app. 1959). 100 van tassel, supra note 13, at 1209-10. 325 indiana health law review in the area of personal fitness for medical staff privileges precise standards are difficult if not impossible to articulate.... the governing board of a hospital must therefore be given great latitude in prescribing the necessary qualifications for potential applicants . . . detailed description of prohibited conduct is concededly impossible, perhaps even undesirable, in view of rapidly shifting standards of medical excellence and the fact that a human life may be and quite often is involved in the ultimate decision of the board.101 standards currently used in evaluating physician competence in peer review fall into one of the following three types: (1) those that rely on the absolute discretion of the decision-makers; (2) those that rely on customary care of the local or a wider community; and (3) those that rely on general negligence standards.1 02 each of these standards is problematic and fails to balance the interest of the stakeholders. the first standard is derived from hospital bylaws with wording such as "the right to remove any member of the medical staff . . . [that] the good of the hospital or the patients may demand"103 or where the level of competence is defined as "best possible care."104 this leaves complete discretion to the peer review decision-makers, provides minimal due process protection for the targeted physician, 101 id. at 1212 (citing jackson v. fulton -dekalb hosp. auth., 423 f. supp. 1000 (n.d. ga. 1976); the author notes that the language that it is "impossible to articulate" standards of medical competence was taken from a case where the court was discussing character qualifications and standing in relation to fitness for medical staff privileges). 102 id. at 1214. 103 id. at 1215 (citing n. broward hosp. dist. v. mizell, 148 so. 2d 1, 2-5 (fla. 1962)). 104 id. (citing wyatt, 345 p.2d at 95). 326 vol. 11:1 2014 hcqia does not provide adequate due process and makes judicial review of the peer review decision very difficult. 105 the second standard relies on what is considered to be customary care. 106 however, there may be disagreement in the local or larger national medical community on what is the proper standard of care, and even when agreed upon, that standard may be detrimental to the quality of patient care. 107 additionally, costly discovery of colleagues' patient records may be required to decide what is customary in a particular hospital.108 the third standard which relies on general negligence standards with bylaws language such as requiring patient care in a "non-negligent manner", may provide slightly more clarity due to influence from malpractice case law but still has inherent problems of vagueness depending whether the "community" or "national rule" standard is used. 109 under any of these standards, there are additional due process concerns when unavoidably the peer review decision-makers have personal and economic dealings with the targeted physician, which has the potential to introduce bias into the process. 110 this is distinctly different from malpractice litigation where the judge or jury has no prior dealings with the defendant.1 this difficulty of judging physician competence due to vague standards makes strict interpretation of due process rights even more important in preventing abuse under hcqia. d. the punishment does not fit the crime in the cases of disputed adverse peer review that have been presented in this note, most involve an accusation of one or more instances of substandard patient care against a backdrop of criticizing hospital policies (drs. ulrich and 105 id. at 1215-16. 106 see discussion infra part iv.b. 107 van tassel, supra note 13, at 1227. 108 id. at 1217-29. 109 id. at 1229-31. 110 id. at 1230. 111 id. at 1229-31. 327 indiana health law review clark) or economic competition (drs. poliner and partrick).112 in no instance has there been an accusation of malice, purposeful patient harm, or necessarily malpractice. however in each case, the hospital and peer review committee were able to deprive the targeted physician of a right and harm his career, as well as remove from the public another choice of a generally capable health care worker. it does not seem the punishment of suspension of hospital privileges fits the crime of having a patient or a few patient complications. this is especially so, in light of the fact that medicine is an art, not a science, and many complications are unavoidable, and every physician has or eventually will have complications from performing treatments. 113 the sanctioning of a physician should be on a graduated scale. depending on the magnitude of the problem, there should be available other, less retaliatory methods of correction, such as education, rehabilitation, monitoring and lessor levels of restriction. 114 a reviewing court should look for evidence of these other corrective attempts in evaluating the reasonableness of an adverse action. one should perhaps take an example from how attorneys are sanctioned within their own profession. disbarment is usually a measure of last resort and a competent lawyer who is negligent and makes a mistake, is generally not subject to professional discipline as well as malpractice liability.115 the npdb is the first time the federal government has engaged in blacklisting since the mccarthy era.116 unlike other forms of blacklisting such as sexual predators, where the risk of harm is much greater, physicians who are serving the community receive far fewer procedural safeguards than those other targeted groups. professor van tassel stated that: 112 kinney, supra note 15, at 58-9, 63. 113 personal communication, frank stinclifield, md, professor of orthopedic surgery, columbia presbyterian medical center, new york, ny, , circa 1983. 114 gunthrie m, guidelines for disciplinary action from peer review. physician executive 35(4): 78-9, 2009. 115 hal r. kuebeman, ethics, lawyer misconduct, and sanctions: the disciplinary committee perspective, c641 al-aba 121, 124 (1991). 116 van tassel, supra note 47, at 2037. 328 vol. 11-1 2014 hcqia does not provide adequate due process in contrast to blacklisting sexual predators, when physician are blacklisted by the federal government, they have not been provided with a procedurally safeguarded opportunity to contest the accuracy of the facts included in the reports that are filed with, and then disseminated by, the npdb ... alleged sexual predators are provided with the additional safeguard of having the highest burden of proof placed on the government to prove the allegations against them. hospitals in peer review only have to establish the allegations against physicians by a preponderance of the evidence. 117 additionally, if we compare other types of black lists such as suspected gang members, suspected terrorists, and no-fly lists; those persons have procedurally safeguarded opportunity to contest the accuracy of alleged membership. in contrast, physicians who are blacklisted, in the vast majority of cases do not have access to the judicial system.118 in hamdi v rumsfeld, the supreme court held that a suspected terrorist's "risk of erroneous deprivation" of his liberty interest was unacceptably high under the government's rule of limiting his due process (the government was concerned about the risk of disclosing of military secrets).119 it is hard to harmonize a rule that guarantees due process for suspected terrorists with one that is denying this protection to physicians who are serving the community.120 117 id. at 2040 (citing conn. dep't of pub safety v doe 538 u.s. 1(2003)). 118 id. at 2041. 119 hamdi v. rumsfeld, 542 u.s. 507, 507-08, 530 (2004). 120 van tassel, supra note 47, at 2094. 329 indiana health law review iv. hcqia does not effectively improve health care quality and is outdated in today's health care environment the lack of well-defined physician competence standards, and the immunity granted under hcqia with subsequent reporting of adverse credentialing actions to the npdb system perpetuate custom-based practices (rather than promoting evidence-based practices). these two elements undermine efforts to improve quality and costs of health care, and are being used to silence physician whistleblowers, which directly also undermine efforts to control the quality and cost of care. 121 a. whistle blowers are at risk of sanctioning under hcqia physicians, because of their training and authority, have a moral responsibility to be strong patient advocates and to voice concerns over inadequate or riskier care, given the patient's relative lack of knowledge especially in today's cost conscious health care environment where the emphasis is on doing more for less. even with this mandate, physicians both historically 22 and presently under the hcqia, can jeopardize their careers in speaking out for patients. the hcqia may actually be hindering the improvement of quality medical care by providing disincentives for physicians to speak out about poor medical care in the hospital setting. 123 hospital peer review could be used to silence a practitioner's disagreement with hospital practices, especially when the criticized activity could affect the hospital's profits, and therefore work against lowering the cost of health care. 124 121 id. at 2032. 122 panella, supra note 42, at 281-82. in the mid 1800's viennese physician dr. semmelweis, was ostracized by the medical community after suggesting that doctors' hand washing could reduce fatal infections arising in new mothers. 123 id. 124 id. at 297. vol. 11:1330 2014 hcqia does not provide adequate due process if a physician is labeled disruptive, a hospital can initiate a peer review proceeding to determine whether the physician's conduct is compromising the quality of the patient care. if the peer review committee finds his behavior to be disruptive, the hospital can institute a variety of corrective measures, including revocation of his hospital privileges. the hospital is protected in this action by a presumption of immunity under the hcqia. if the targeted physician decided to challenge this presumption in court, he is faced with the high evidentiary hurdle imposed by hcqia of showing by a preponderance of the evidence that: 1) the hospital peer review was not based on a reasonable belief that the review was in furtherance of quality health care; 2) reasonable efforts were not used in obtaining the facts surrounding the case; 3) the physician was not afforded adequate notice and hearing procedures; and 4) a reasonable belief did not exist that the review was actually warranted.125 the targeted physician faces two additional problems in avoiding sanctions. first, the hospital has significant power in selecting the hearing officers due to the language of the hcqia which states: hearings can be conducted before an arbitrator mutually acceptable to the physician and hospital, or a hearing officer or panel of individuals, who are appointed by the hospital, provided there is no economic conflict with the physician.126 thus, the hearing officer(s) could be hostile to the physician in non-economic matters. second, the issue of what constitutes "disruptive"ebehavior is not well delineated and can be left to subjective interpretation under the lens of the hospital's politics and finances. for instance, a major economic producer's behavior could be allowed much greater latitude than that of a physician whose economic impact is small.127 the danger of criticizing the hospital and being labeled disruptive is illustrated by the cases of drs. ulrich, clark and wieters who each were sanctioned for complaining 125 42 u.s.c. § 11112 (a) (2012). 126 42 u.s.c. § 11112(b)(3) (2012) (emphasis added). 127 panella, supra note 42, at 286-87. 331 indiana health law review about quality of care issues at their respective hospitals. 128 this potential for being labeled as disruptive and being a target of an adverse peer review action and being blacklisted has a significant chilling effect on physicians speaking out about potential problems with patient care. additionally, if peer review is perceived as unfair then it could make physicians reluctant to speak out or bring their peers into the peer review process thus also compromising quality of care.129 as we become more aware of mistakes being made in patient care, rising health care costs, and a projected looming physician shortage, it becomes increasingly important that the peer review process be perceived as fair and that physicians be protected in expressing their views. b. customary care is perpetuated under hcqia professor van tassel has put forth the argument that peer review as currently practiced relies heavily on customary care, which is based on physician preference, geography, and not on objective, scientific evidence.130 therefore, according to the argument, customary care does not improve the quality or cost of health care: "customary care" is that care which would customarily be given by other physicians under the same or similar circumstances. this practice of providing customary care is also referred to by many as "eminence-based medicine" and it is the normative practice in the united states. unfortunately, a steadily growing number of studies demonstrate that many customary treatment choices have a negative impact on quality of care. another 128 see discussion of cases supra parts i, ii.e. 129 panella, supra note 42, at 281-82. 130 katherine van tassel, harmonizing the affordable cared act with the three main national systems for healthcare quality improvement: the tort, licensure and hospital peer review systems, 78 brook. l. rev. (forthcoming 2013) (manuscript at 4-5), available at http://ssrn.com/abstract=2150825. 332 vol. 11:1 2014 hcqia does not provide adequate due process large group of studies indicate that there is a wide variation in customs across the country and that the choice of customary treatment is more linked to geography than to quality.131 one example is related to the evidence that use of aspirin within the first twenty-four hours after a heart attack increases the rate of survival. but of the hospitals studied in 2004, only a fraction of eligible patients received this simple aspirin treatment. 132 studies also show that patients in idaho falls are twenty times more likely to have lumbar fusions than ones living in bangor, maine and the rate of spinal surgery in bradenton, florida is almost double that in tampa, florida.133 these studies show that customary care is based on the medical culture of a particular area and may well be unrelated to a quality choice for the patient. customary care is also expensive and not cost effective. for example, mcallen, texas has been brought to light nationally as one of the most expensive medical communities and an example of the disconnect between cost and quality. medicare spends twice the national average on medicare enrollees in mcallen as compared to neighboring el paso, a similar community; yet mcallen's hospitals performed worse than el paso's on multiple medicare quality metrics.134 131 id. 132 id. at 6. 133 ctr. for the evaluative clinical sci., dartmouth atlas of health care: studies of surgical variation spine surgery, dartmouth atlas.org, http://www.dartmouthatlas.org/downloads/reports/spine surgery_2006.pdf (last visited jan 3, 2014). 134 atul gawande, the cost conundrum, the new yorker, june 1, 2009, available at http://www.newyorker.com/reporting/2009/06/01/ 090601fa factgawande?currentpage=all. "between 2001 and 2005, critically ill medicare patients received almost fifty percent more specialist visits in mcallen than in el paso. . . they received one-fifth to two-thirds more gall bladder operations, knee replacements, breast biopsies, and bladder scopes. they received two to three times as many pacemakers, implantable defibrillators, cardiac-bypass operations, carotid endarterectomies, and coronary-artery stents. and medicare paid for five times as many home-nurse visits." 333 indiana health law review the hcqia and the advantages that it grants to the hospitals and peer reviewers have the effect of making physicians reluctant to deviate from the customary care standard in their community, and that customary care is not always the best care for the patient. c present standards under hcqia create risks for hospitals and peer review committees on the hospital side, it must navigate the narrow waters of providing quality care by weeding out incompetent physicians who may cause potential medical malpractice liability for the hospital, but in doing so it may expose itself to antitrust liability when denying or limiting a physician's privileges. the peer review process is jcaho mandated and a standard method of health care quality control. mandatory due process protocols, consistent and clearly enunciated standards, as well as a root analysis and rehabilitative approach to medical errors and physician behavior, so that all parties feel fairly treated, would go a long way to avoiding costly litigation. not withstanding the fact that few antitrust cases brought by physicians adversely affected by peer review decisions have been favorable to the plaintiff physician13 , a hospital is still 135 barbara k. miller, note, defending the system. application of the intraenterprise immunity doctrine in physician peer review antitrust cases, 75 tex. l. rev. 409, 411-12 (1996) (citing bcb anesthesia care, 36 f.3d at 667 (staffing and privileges litigation decisions "almost always come to the same conclusion: the staffing decision at a single hospital was not a violation of section 1 of the sherman act"); charity scott, medical peer review, antitrust, and the effect of statutory reform, 50 md. l. rev. 316, 333 (1991) (whether there is really a "need for peer review immunity considering how few physicians succeed on their antitrust allegations"); joe sims & kathryn m. fenton, antitrust defenses to peer review and medical staff privileges claims, in developments in antitrust health care law 15, 15 (phillip a. proger et al. eds., 1990) ("the low success rate for antitrust challenges to medical peer review and staffing decisions [can be] due to the various defenses available to defendants"); tim a. thomas, annotation, denial by hospital of staff privileges or referrals to physician or other health care practitioner as violation of sherman act (15 uscs 1 et seq.), 89 a.l.r. fed. 419, 426 (1988). contra bolt v. vol. 11:1334 2014 hcqia does not provide adequate due process exposed to the expense and time of litigation.13 6 the willingness of targeted physicians to file antitrust law suites is at least partially explained by the economic consequences of hospital privilege denial, as a physician without hospital privileges is severely limited in her ability to care for patients.137 one commonly asserted antitrust allegation in the peer review context is a section 1 violations under the sherman act, that is either that the members of the peer review committee conspired among themselves, andlor that the members of the peer review committee conspired with the hospital to limit the physician's access to the hospital's facilities.138 the three common defenses that a hospital can put forth when it faces a section 1 conspiracy allegation are the state action doctrine, the hcqia, and the intraenterprise immunity doctrine. 139 in summit health v pinhas the supreme court held that actions taken for anticompetitive purposes were not protected under the hcqia and that the hospital's peer review process affected interstate commerce.140 additionally, where a hospital's actions were allegedly taken for the sole purpose of excluding a doctor from performing his opthalmiologic services within a geographic area, hcqia immunity did not apply, and federal jurisdiction under the sherman act was applicable.141 the state action defense doctrine, which was first recognized by the united states supreme court in parker v brown, has effectively become unavailable to private hospitals after the united states supreme court's decision in patrick v. burget 142because most private hospitals are halifax hosp. med. ctr., 891 f.2d 810, 828 (11th cir. 1990) ("reversing the directed verdict awarded to a hospital on charges of antitrust violations regarding the hospital's peer review activities"). 136 miller, supra note 135, at 412. 137 id. at 417 (citing john j. miles, 2 health care & antitrust law: principles and practice § 10:1 (1995)). 138 id. at 412. 139 id. at 417. 140 summit health, ltd. v. pinhas, 500 u.s. 322, 333 (1991). 141 id. 142 patrick v. burget, 486 u.s. 94 (1988). 335 indiana health law review unable to fulfill the two-prong test that was first stated in dealers ass'n v. mideal aluminum, inc.: that "the challenged restraint must be "one clearly articulated and affirmatively expressed as state policy"' and "the policy must be "actively supervised' by the state itself."143 the intraenterprise immunity doctrine has been used as a third area of defense in a section 1 sherman act claim if the defendant hospital can claim that it and the peer review committee acted as a single entity. however the circuit courts are split on the use of this defense. 144 additionally this defense would fail if a personal stake exception exists such as when a peer review member or hospital agent acts for personal gain. 145 therefore following a strict policy of using impartial peer reviewers is mandatory to avoid liability. there have been several cases of multimillion dollar settlements made by hospitals to resolve false claims act liability for unnecessary procedures, where the hospitals were alleged to have been aware of conduct engaged in by its medical staff, but nevertheless, took no action to address the quality of care or medical necessity concerns because the physician was a high producer or the hospital wanted to maintain their profitability. 146 since peer review 143 dealers ass'n v. midcal aluminum, inc., 445 u.s. 97, 105 (1980). 144 miller, supra note 135, at 423-24 (citing copperweld corp. v. independence tube corp, 467 u.s. 752, 770-72 (1984): two conditions if met, make the intraenterprise conspiracy immunity is available -1) the parent and its alleged conspirators have a unity of economic interest, and 2) the parent exerts control over the decisions of its officers, employees, and agents) (the third, fourth, sixth and seventh circuits have held that a hospital is not capable of conspiring with its medical staff, while the eleventh circuit held to the contrary.). 145 id. at 434 (referencing islami v. covenant med. ctr., inc., 822 f. supp. 1361, 1382 (n.d. iowa 1992) where summary judgment was denied on antitrust claims against a hospital and peer review physicians, noting that the personal stake exception exists when evidence indicates that the reviewing physicians "were acting for their own personal benefit."). 146 bna insights: health law resource center, supra note 17 (citing press release, dep't of justice. lafayette general medical center to pay $1.9 million to settle fraud allegations in connection with medically unnecessary cardiology procedures, (jan. 11, 2008), available at http://www.justice.gov/usaollaw/news/wdl20080111.pdf, and 336 vol. 11:1 2014 hcqia does not provide adequate due process frequently operates in its own silo, there is a tremendous risk that information that would trigger compliance concerns will remain sealed within the peer review apparatus and will never be addressed. 147 to avoid these problems, it is advantageous for the hospital to conduct peer review in a manner that will withstand governmental scrutiny. a systematic "random sampling of records" and possible use of outside clinical reviewers would help ensure a non-biased peer review process. it has been recommended that the hospital compliance department should consider regular evaluation of the peer review process.14 8 d. modern health care systems and "obama care" have made hcqia outdated the evolution of health care is quickly making the hcqia an anachronism. in 1986 congress enacted the hcqia under the presumption that adverse outcomes are mainly due to individual carelessness and that by identifying these individuals through the peer review process, and restricting their practice, adverse events would be reduced.149 but modern thinking is that, although individuals do make mistakes, adverse outcomes are largely the product of system-level flaws and simply punishing individuals would not correct the larger problem.150 additionally today, surgeons, anesthesiologists, and other invasive specialists increasingly practice in outpatient centers, and primary care physicians no longer treat hospitalized patients, thus making hospital peer review and the associated npdb reporting inaccurate in identifying incompetent physicians.151 kurt eichenwald, tenet healthcare paying $54 million in fraud settlement, n. y. times aug. 7, 2003, available at http://www.nytimes.com/2003/08/07/business/tenet-healthcare-paying54-million-in-fraud-settlement.html?pagewanted=print&src=pm.) 147 id. 148 id. 149 haavi morreim, moral hazard: the pros and cons of avoiding data bank reports, 4 drexel l. rev. 265, 288-91 (2011). 150 id. at 289. 151 id. at 288-91. 337 indiana health law review with the passage of the patient protection and affordable care act (ppaca) also known as obama care or the aca, and the anticipated creation of accountable care organizations (acos) (with attendant protection from antitrust laws) there will be a greater concentration of physicians in large groups and conglomerates. 152 this leaves the smaller physician practices vulnerable to bullying thru censorship. on the flip side, these large conglomerates, which are closed systems, will eventually encompass a major percentage of available physicians. both these situations create an environment for peer review abuse, thus making stronger due process protection during peer review essential, both to protect the reviewed physician and to preserve patient choice. alternatively, these conglomerates would likely have their own internal policing systems (with a registry of physician quality issues), which make hcqia unnecessary. additionally, the standards used under hcqia are based on customary care which has evolved from a fee-forservice system of health care reimbursement (which encourages more utilization, rather than less).153 the movement towards acos and a quality and outcome based reimbursement system would likely make hcqia, without some modification an anachronism. the centers for medicare and medicaid services (cms) has adopted several initiatives that provide strong financial incentives for quality of care including non payment for "never events," higher payments based on quality measures and patient outcomes under the premier quality initiative for hospitals and the physician quality reporting system (pqrs) for physicians. 154 the aca has created several initiatives for the development of best practices for hospitals and physicians. 155 the aca has also essentially turned private insurers into regulatory agencies of sorts by 152 j. d. harrison, health-care law driving doctors away from small practices, toward hospital employment, wash. post, july 19, 2012, available athttp://www.aaos.org/govern/public/pressreleases/ washpostarticle.asp. 153 van tassel, supra note 13, at 1234. 154 van tassel, supra note 130, at 11-12. 155 id. at 14-15. 338 vol. 11:1 2014 hcqia does not provide adequate due process requiring them, under the health benefit exchanges that have been created, to evaluate providers through the same quality benchmarks that the cms uses under pqrs.158 the quality improvement provisions under the aca and cms together create a powerful health care quality regulatory mechanism that in today's health care environment makes the hcqia shield of immunity an instrument that does more harm than good. v. proposed solutions some legal writers feel that the hcqia provides only a narrowly defined immunity as it only shields monetary damage, but not injunctions, and the hcqia's good faith requirement only protects those situations where the facts could not support an antitrust claim anyways. 157 given that opinion on limited protection and the expressed negative aspects of the hcqia, several scholars have advocated for its repeal. however, repeal may be difficult given that the hcqia is still strongly supported by organized medicine.15 8 several other less dramatic and more easily achievable methods of reform are outlined. a. improve due process under hcql4 to comport with constitutional standards the last sentence of 42 u.s.c. § 11112(b)(3), "a professional review body's failure to meet the conditions described in this subsection shall not, in itself, constitute failure to meet the standards of subsection (a)(3)"159 should be repealed or amended. by removing the hcqia's optional requirement for due process, courts would be required to 156 id. at 15-16. 157 miller, supra note 135, at 420-21 (citing barry r. furrow et al., health law 420-21 (1995)(recognizing that congress "enacted extremely narrow immunity legislation for peer reviewers" when it passed the hcqia)). 158 kinney, supra note 15, at 78, 80 (noting that the american medical association has continued to defend immunity under the hcqia). 159 42 u.s.c. § 11112(b) (2013). 339 indiana health law review review peer review actions under the mathews v eldridge three-prong test.160 analysis of peer review due process under the 3-part balancing test of mathews would go as follows: 161 1) the private interest affected by the official action is great as a physician's medical career hangs on the decisions made. 2) the risk of erroneous deprivation through the procedures used is also significant as reliance on standards of customary care or the discretion of hospital administrators to judge physicians' competency creates a high risk of error, which also makes the npdb data inaccurate and misleading. the evidentiary rules or practices applicable in a formal courtroom setting are not followed, thus allowing for hearsay to factor into the decisions. there is also significant state-tostate disparity in the level of judicial review given to adverse peer review decisions, making the potential for adverse review and unsuccessful judicial appeal more related to geography rather than quality of patient care provided. 162 the "reasonable belief" standard required to qualify for hcqia immunity is presently open to very loose interpretation by the courts, and it should be addressed by congress through amendment of the hcqia or by dhhs through regulation. for example, the standard should be to consider all evidence in the record as a wholelike the united states supreme court 160 mathews v. eldridge, 424 u.s. 319, 335 (1976). 161 kinney, supra note 15, at 82-83; see also van tassel, supra note 47, at 2067-92. 162 van tassel, supra note 47, at 2087. 340 vol. 11:1 2014 hcqia does not provide adequate due process ruling in nlrb v. universal camera corp.163 there should also be effective sanctions against abuse through monitoring by the government (by the npdb), independent quality improvement organizations, or privately by jcaho; as the courts have proven to be ineffective in sanctioning abuse.164 3) the government has an interest in improving quality of care, lowering health costs, and protecting patients from bad doctors. the administrative burdens of additional safeguards are reasonable. the lack of complete due process protection during peer review and the potential for npdb listing prevent those goals from being met. the npdb has not been documented to be clearly effective, is inaccurate, and can be both over inclusive and under inclusive. 65 the threat of a npdb listing and the bullying effects of peer review can prevent physicians from being effective patient advocates in this era as hospitals place increasing importance on profit margins. providing physicians with due process would further these goals and be in the public's interest. congress could amend the hcqia to limit participation in federal health programs to hospitals that follow due process guidelines. these changes should not entail additional cost to the government and should be smooth to implement as government run hospitals like the va are already required to provide due process to physicians in peer review.166 subscribing to these standards would allow 163 kinney, supra note 15, at 83; see also nlrb v. universal camera corp., 340 u.s. 474 (1951). 164 kinney, supra note 15, at 83. 165 morreim, supra note 149, at 278-88. 166 van tassel, supra note 47, at 2094. 341 indiana health law review reviewing courts a baseline to judge the validity of adverse peer review actions. barring congressional legislative action, a higher level of judicial oversight of due process procedures is needed to serve as a check on hospital peer review. for instance, the supreme court of alaska in liester held that in order to establish adequate notice, the hospital must identify both "the objective criteria that the physician has violated and the manner in which the physician violated the criteria."167 a more stringent and similar judicial interpretation of the hcqia language, such as "the reasonable belief' 168 standard, would strengthen the due process protection under peer review. there is motivation for those involved in the peer review process to follow the hcqia standards for "adequate notice" and "fair" process, which if they were adhered to then they would prevent the targeted physician from suing for damages. nevertheless, the targeted physician can still sue for injunctive and other types of equitable relief based on constitutional, common law, or medical staff by-law guarantees of fair process. 169 however, these legal challenges generally fail due to the vague standards (which fail to provide adequate notice to physicians and allow for their arbitrary application) that make the procedural safeguards (which themselves are often loosely followed) minimally protective for the challenging physician. 170 the challenging physician is confronted with the hcqia 167 van tassel, supra note 13, at 1208 (citing kiester v. humana hosp. alaska, inc., 843 p.2d 1219, 1225 (alaska 1992)) ("both the criteria used to judge competency and the violations should be identified with sufficient clarity to allow the physician to prepare a full and fair defense against the claims of the hospital."); see also garrow v. elizabeth gen. hosp. & dispensary, 401 a.2d 533 (n.j. 1979) (citing 148 christenson v mount carmel health, 678 n.e.2d 255, 262-63 (ohio ct. app. 1996)). 168 42 u.s.c. §11112 (2013). 169 van tassel, supra note 13, at 1197 n.96 ("many state statutes provide a much broader immunity for both the individual participants in the peer review process and the hosptial. unlike hcqia, in most cases, the state immunity provisions will not provide immunity from federal antitrust liability.") 170 id. at 1204-10. 342 vol. 11:1 2014 hcqia does not provide adequate due process provision that professional review actions are presumed to have met the statutory standards unless the "presumption is rebutted by a preponderance of the evidence."171 nevertheless, although few and far in between, there have been successful challenges to hcqia immunity. these challenges have been brought under various theories including antitrust, 172 violation of constitutional rights, 173 and public policy protected conduct. 174 in all of these, the plaintiff was able to show malice on the part of the hospital or peer review committee. when reviewing a challenge to an adverse peer review proceeding, courts should look for certain situations that have been identified as indicative of malice in the peer review process and that require heightened review by hospital decision-makers, attorneys and judges, such as: [wlhen the peer review process results in the denial of privileges to an apparently competent physician where (1) complaints are initiated outside of the normal hospital quality assurance channels; (2) actions are taken without affording the doctor due process; (3) due process-notice and opportunity to be heard-is a sham; (4) incompetence is alleged notwithstanding the fact that the doctor's treatment represents an alternative, but recognized, medical school of thought; or (5) the hospital did not consider reeducation, required consultations, monitoring, or 171 kinney, supra note 15, at 66 (citing 42 u.s.c. § 11112(a) (2008);joshi v. st. luke's episcopal-presbyterian hosp., 142 s.w.3d 862, 866 (mo. ct. app. 2004)). 172 summit health, ltd. v. pinhas, 500 u.s. 322, 333 (1991); see also islami v. covenant med. ctr., 822 f. supp. 1361, 1379-80 (n.d. iowa 1992). 173 ulrich v. city and county of san francisco, 308 f.3d 968 (9th cir. 2002) (violation of first amendment right of free speech and fourteenth amendment right of due process). 174 clark v. columbia/hca info. servs., inc., 25 p.3d 215 (nev.2001) (explaining that the revocation of staff privileges was not made with reasonable belief that it was in furtherance of quality health care, and whistle-blowing is conduct protected as a matter of public policy). 343 indiana health law review privilege restrictions as alternatives to a total revocation of privileges.175 any of these should signal possible abuse of the peer review process and warrant more detailed investigation of the facts. b. use a better-defined standard for judging physician competence professor van tassel has proposed the use of a combination of evidence-based medicine (clinical practice guidelines or cpgs) and tort doctrine as a standard to measure physician competence in peer review. 176 clinical practice guidelines, many of which have been developed by private physician organizations such as the american college of physicians and the american academy of pediatrics, are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." 177 local or centralized cpg committees should be formed to review, adopt, or modify the cpgs that have been put forth by the national practice organization, and once adopted, physicians should be expected to comply with them or document the reasons for deviating.178 one advantage of using better defined patient care clinical guidelines is that deviation from care is more readily detectable, allowing earlier and probably less severe remedial measures for the involved caregiver. there would also be minimal need for discovery of other physicians' care in review situations, and this may also help guide courts in 175 pauline martin rosen, medical staff peer review: qualifying the qualified privilege provision, 27 loy. l.a. l. rev. 357, 395-96 (1993) (footnote omitted). 176 van tassel, supra note 13, at 1232. 177 id. at 1242 (citing inst. of med., clinical practice guidelines: directions for a new program 8 (marilyn j. field & kathleen n. lohr eds., 1990)); see also the national guideline clearinghouse, http://www.guideline.gov (lasted visited jan. 2, 2014) (providing access to current clinical guidelines). 178 van tassel, supra note 13, at 1246-48. 344 vol. 11:1 2014 hcqia does not provide adequate due process malpractice cases.'7 9 since cpgs evolve and presently do not cover all medical situations, van tassel proposed using the tort "reasonable care " standard as a back up. 8 0 c. rely on a systems approach to address medical errors and improve health care the modern thinking in regards to most hospital medical errors is that system flaws rather than an individual cause them.181 the 1999 iom landmark study started a national health care movement to improve patient safety, based on an evidence-based systems approach of reducing medical errors, recognizing that "safety is primarily a systems problem."182 a root analysis approach to discover the system defect, rather than finger pointing and blame of specific caregivers, would encourage a culture of openness and possibly lead to more success in improving health care quality and controlling cost. if a physician is discovered to have incompetencies, a more rehabilitative approach, with alternatives such as reeducation, required consultations, monitoring, or privilege restrictions, would be a less retaliatory and more productive method of correcting the problem while still preserving medical manpower. physicians would also be more willing to report on their colleagues' insufficiencies if they know that the review process will be fair and that rehabilitation rather than retaliation will be the end result. reviewing courts should look for these features in any contested peer review action. 179 id. at 1249. 180 id. at 1251. 181 morreim, supra note 149, at 289. 182 brian m. peters & robin locke nagele, promoting quality care & patient safety.' the case for abandoning the joint commission's "selfgoverning" medical staff paradigm, 14 mich. st. u. j. med. & l. 313, 344-45 (2010) (citing lucian l. leape et al., what practices will most improve safety?:. evidence-based medicine meets patient safety, 288 j. am med. ass'n 501, 504 (2002); comm. on quality of health care in am., inst. of med., crossing the quality chasm: a new health system for the 21st century ( national academy press 2001),available at http://www.nap.edulcatalog.php?recordid=10027. 345 indiana health law review d. use an independent board for peer review in 2001 the maryland general assembly appointed a study, which was conducted by the university of baltimore. the study found that there was a high potential for whistle blowing doctors who alienated hospital officials to be labeled disruptive and then suffer hcqia immunity protected adverse peer review actions. the study recommended the formation of a state physician administrative review board that would investigate potential hcqia immunity abuse by hospitals and review boards.183 such an independent board would be free of the inherent biases of a hospital based peer review committee and is an option that should be considered. v. conclusion the hcqia, as presently applied in the private hospital setting, does not appear to serve its intended purpose of improving quality of care and protecting the public. furthermore, because of the lack of enforcement of due process and poorly defined standards in the peer review process, there is a high potential for violating the property and liberty rights of the targeted physicians. the risk of injury makes the the hcqia outdated or unnecessary in the modern health care environment. better defined standards of care, ensuring that due process procedures are followed through either repeal or amendment of hcqia or via stricter judicial interpretation of peer review actions, would help preserve constitutional rights of our physician caretakers and help improve quality of care. other methods of improving health care quality, including a systems approach to medical errors, and a more rehabilitative approach to physician behavior and competence are also suggested. 183 panella, supra note 42, at 296-97(citing steve twedt, the cost of courage: doctor says whistleblowers need more protection, pittsburgh post-gazette, oct. 29, 2003, available at http://www.postgazette.com/pg/03302/235115.stm.). vol. 11:1346 sixteen myths of medicine and medical malpractice norman g. tabler, jr.* myth i: america has the best health care in the world ................................................................... 364 myth ii: you get what you pay for (in health care) ............................................................. 366 myth iii: the best health care is the most expensive health care ........................................ 366 myth iv: more hospital care is better care ............. 367 myth v: we don’t ration health care ........................ 368 myth vi: the tort system should weed out bad doctors .................................................................... 370 myth vii: when a case goes to trial, there is a winner (other than the attorneys) .......................... 371 myth viii: juries award more money than judges .... 372 myth ix: a hospital-acquired infection must be the hospital’s fault ....................................... 373 myth x: unexpected readmission is evidence of poor treatment ......................................................... 374 myth xi: a low cap on damages reduces plaintiff recoveries ...................................................... 375 myth xii: there is such a thing as a never event ..... 376 myth xiii: an insurer should have low administrative costs ............................................. 378 myth xiv: there’s an answer to, “should physicians 379 apologize for medical errors?” ................................... 379 myth xv: an apology necessarily involves admission of liability .................................... 380 myth xvi: apologizing for medical errors is always a mistake ........................................................ 381 conclusion ...................................................................... 383 http://dx.doi.org/10.18060/3911.0020 364 indiana health law review vol. 13:2 good morning. i was delighted and flattered to receive professor terry’s invitation to speak this morning. i was even more delighted when he told me the topic: myths of medicine and medical malpractice. i was delighted because this gives me a rare opportunity to vent in public—to complain about the misconceptions and erroneous beliefs that i have encountered on a daily basis in my forty plus years of representing clients in the health care industry. with your indulgence, i want to start from a thirtythousand-foot view of american health care in general and gradually narrow our focus to the tort system of addressing claims of professional liability. if time allows, i would like to devote a few minutes to a special interest of mine: the role of apologies in resolving professional liability issues. myth i: america has the best health care in the world here is the first myth—one that survives despite mountains of evidence to the contrary. the myth is that the americans have the best health care in the world. you hear and read this myth every day of the week, from the sophisticated and unsophisticated alike. here is the speaker of the united states house of representatives, john boehner, on the july 1, 2012, edition of the cbs sunday morning staple face the nation: “governor romney understands that obamacare will bankrupt our country and ruin the best health care delivery system in the world.”1 and on the senate side of congress, here’s then-senate minority (now majority) leader mitch mcconnell’s take on the matter: the united states has “the finest health care system in the world.” when speaker boehner’s office was asked for evidence to back up the claim, a spokesman observed that “there is no *counsel, faegre baker daniels llp; former senior vice president & general counsel, indiana university health. 1 louis jacobsen, 'best health care delivery system in the world'? john boehner thinks so, politifact.com (jul. 5, 2012, 10:30 am), http://www.politifact.com/truth-o-meter/article/2012/jul/05/best-healthcare-delivery-system-world-john-boehne/ [https://perma.cc/ec66-hrzx] (italics added). 2016 365 sixteen myths of medicine and medical malpractice generally accepted measure for quality of care,” but said that there are several measures by which the united states fares well. for example, in 2004 the commonwealth fund rated the united states the best in four out of five preventive-care categories when compared to four other advanced industrialized countries. and, he went on, the united states has strong survival rates for patients with cancer.2 finally, the speaker’s spokesman invoked the old saw: wealthy foreigners flock to the united states for their care. to me, that’s like saying we know the dominican republic has the best housing in the world because rich people have winter homes there. but let’s pause to analyze this evidence offered on behalf of the speaker. we’ll start with the statement that “there’s no generally accepted measure for quality of care.” there are two glaring problems with that statement. first, it was the speaker who claimed that there is a generally accepted measure: he said that the united states ranks number one by that measure. second, with the apparent exception of the speaker, everyone knows that generally accepted measures of quality do, in fact, exist. and, again with the apparent exception of the speaker, everyone knows what some of the measures are and where to find them. i suggest that the speaker google this phrase: “medicare and quality measures.” he’ll find a lifetime of reading material, all of it focused on generally accepted quality measures. and notice the hasty retreat by the spokesman from the speaker’s sweeping claim to overall superiority to the infinitely narrower and more modest claim of best in four out of five preventive-care categories when compared to four other countries and “strong survival rates” for patients with cancer. those are admirable rankings, if accurate, but they are nowhere near to proving the unqualified overall superiority the speaker claimed. the spokesman cited a 2004 survey by the commonwealth fund. however, the speaker might be interested in a study released by the same organization just last summer. the headline of the press release accompanying sums up the findings nicely: “u.s. health 2 see id. 366 indiana health law review vol. 13:2 system ranks last among eleven countries on measures of access, equity, quality, efficiency, and healthy lives.”3 not best: worst. not first: last. myth ii: you get what you pay for (in health care) the commonwealth fund study provides a great segue to the next myth: that you get what you pay for in health care. that study, while ranking the united states eleventh out of eleven in quality, also ranked us as the most expensive of the eleven countries. and the contest was by no means close. the average annual cost in the united states was over twice the cost in the united kingdom, which, incidentally, ranked first in quality: $8,500 in the united states versus $3,400 in the united kingdom. the study puts the lie to the you-get-what-you-pay-for myth in two different ways. the more obvious of the two is that the worst health care has the highest cost, and the best health care has the lowest cost. the second of the two ways deserves its own section. here it is. myth iii: the best health care is the most expensive health care to the surprise of no one, with the possible exceptions of speaker boehner and senator mcconnell, the 2014 study by the commonwealth fund revealed that the factor that most significantly dragged the united states down in the rankings was a wide-spread lack of access to primary care, especially access by the poor. primary care—almost by definition—is the least expensive care. it is much less expensive than specialty care and, of course, vastly less expensive than hospital care. but the unavailability of that inexpensive primary care has the inevitable result of increasing the need for, and consumption 3 press release, the commonwealth fund, u.s. health system ranks last among eleven countries on measures of access, equity, quality, efficiency, and healthy lives, (jun. 16, 2014), available at http://www.commonwealthfund.org/publications/pressreleases/2014/jun/ us-health-system-ranks-last [https://perma.cc/zxf5-33cv]. 2016 367 sixteen myths of medicine and medical malpractice of, more expensive specialty and hospital care. so the best quality care is the least expensive care. it is primary care. if you ask experts in the relevant fields—say, population management and disease prevention and control—to name the best investments for improving health, they do not cite multi-million dollar robotic equipment or subspecialist physicians in exotic fields. they cite investments that are very—even shockingly—inexpensive. they suggest sending social workers and dental hygienists into the inner city. they suggest sending drivers to assure that people have transportation to their doctors’ offices and clinics. so the best care is not the most expensive. the best care is, relatively speaking, dirt cheap. the myth is not just wrong. it is the precise opposite of the truth. what is more, the myth is harmful because it is so misleading. myth iv: more hospital care is better care somehow this myth survives—the myth that more hospital care is better care. think how often you read about a celebrity who has checked into a hospital because he “needs the rest.” rest? in a hospital? with all the busy nurses and aides working around the clock? with the sounds of carts wheeling through the halls twenty-four hours a day? not to mention the comings and goings of people who are really sick—the ones who are in the hospital because they are sick rather than because they want to rest. if the celebrity wants rest, he would be better off in a ritzcarlton hotel. it would be a lot quieter—a lot more restful. and it would cost only a fraction of a hospital stay. and the ritz-carlton would be safer than a hospital. those of us in the industry or who serve the industry don’t like to acknowledge it in public, but a hospital is not a particularly safe place to be. why? because it is full of sick people. and the acuity—the degree of sickness—increases every year. there is a reason we have a term called “hospitalacquired infections” but not a term called “hotel-acquired infections.” it is because people regularly get sick, or sicker, from exposure to infections present in hospitals. that does not happen in hotels to any significant degree. federal law and some state laws do not seem to take this factor into consideration when they impose mandatory 368 indiana health law review vol. 13:2 minimums on length-of-stay benefits in health insurance plans. the best known of such laws is the newborns’ and mothers’ health protection act of 1996 (the newborns’ act),4 enacted as an amendment to the employee retirement income security act of 1974 (erisa),5 which generally mandates coverage of a minimum of forty-eight and ninetysix hours, respectively, for vaginal and cesarean births, and prohibits incentives that would encourage earlier discharges. there is no doubt that the intentions behind the newborns’ act were entirely benign. (besides, given the name of the act, who would dare oppose it?) but if the mother and child do not need forty-eight or ninety-six hours, is it always a great idea to keep them in the hospital? might it not be better, cheaper, and safer to allow them to spend the last night in the ritz-carlton? or, more realistically, how about providing a home care nurse for a day or two? myth v: we don’t ration health care this is the most fascinating of all the myths: that in america we do not ration health care. it is as though, at birth, every american swears an oath to deny that we ration health care and to agree that rationing health care would be a mortal sin. so, whenever anyone opposes a health care program, he condemns it as a plan to ration health care. it happened with the affordable care act, and it happened with various state medicaid programs, most notable governor john kitzhaber’s oregon health plan.6 but what is even more fascinating is the response of program proponents to the accusation. they do not say, “of course, it’s rationing health care. there’s a limit on how 4 newborns’ and mothers’ health protection act of 1996, pub. l. no. aw104-204 (1996). 5 employee retirement income security act of 1974, pub. l. no. 93406 (1974). 6 for a discussion, see jonathan oberlander, health reform interrupted: the unraveling of the oregon health plan, health aff., (dec. 2006), available at http://content.healthaffairs.org/content/ 26/1/w96.full?sid=5e5f6332-5a32-41a8-adbb-d376bde2b65d [https:// perma.cc/h9xk-ay6p]. 2016 369 sixteen myths of medicine and medical malpractice much we’ll spend on health care. so we ration it. and we try to do it rationally.” instead, they tacitly agree with the premise that rationing health care would be unthinkable. so they defend the program by denying that it involves rationing health care. america has always rationed health care. before the inception of medicare in the mid-sixties, we rationed it primarily through the free market system. providers decided where to locate and not locate and how much to charge. members of the public who had geographic access and financial capability got health care; those without access and capability went without. that’s how we rationed it. of course, even before medicare, there were various governmental assistance programs for the needy. they rationed health care in an even more explicit way than through the free market system. they set budgets and eligibility requirements. then they rationed available health care, within the limits imposed by those budgets and eligibility requirements. medicaid now plays that role, and in a big way. medicaid is the largest health insurance program in the united states. but let’s stick with health care as it applies to those who don’t qualify for medicaid or other programs for the needy. for those tens of millions, medicare is without a doubt the primary force in american health care. interestingly, though, medicare exerts all its power indirectly. how? by setting reimbursement rates and policies that then determine how health care providers (most of them private) deliver (or don’t deliver) care. if medicare rates are high in certain specialties and low in others, the result is an overall increase in the availability of the former specialty care and decrease in the latter. the chronic shortage in primary care is a conspicuous example. remember the commonwealth fund study finding that americans have less access to health care than any other industrialized nation?7 it showed that about 40% of 7 press release, the commonwealth fund, u.s. health system ranks last among eleven countries on measures of access, equity, quality, efficiency, and healthy lives (june 16, 2014), available at http://www.commonwealthfund.org/publications/press370 indiana health law review vol. 13:2 respondents with below-average income reported that during the previous twelve month they had foregone health care due to cost.8 try telling them that we do not ration health care. let’s be clear, though: this may (and probably does) mean that we do a poor job of rationing. but it doesn’t mean that rationing is in itself bad. myth vi: the tort system should weed out bad doctors now let’s narrow our focus to the tort claim system for resolving professional negligence disputes in the medical area. in this context, we often hear the complaint that the tort system is ineffective in weeding out incompetent physicians. and professor hyman has very persuasively demonstrated that the system is, indeed, ineffective in doing that.9 the tort system does not weed out bad doctors. but i’d like to go one step deeper in the analysis and ask, “why should the tort system weed out bad doctors. why should we have that expectation?” i can think of three different ways to address the question, and by all three of them, the answer is the same: we should not rely on the tort system for that purpose. the first of the three comes from professor hyman’s study: such reliance is misplaced because the system is unreliable for that purpose. the second way is by analogy to other industries and other walks of life. imagine that you ask the federal aviation authority how it weeds out bad pilots. the faa responds that if there is a crash and someone sues and proves the cause was pilot negligence, the pilot gets fired. how would you feel about that as a method for weeding out bad pilots? or say you ask a local hospital executive about medical staff credentialing, and he says, “oh, we rely on malpractice releases/2014/jun/us-health-system-ranks-last [https://perma.cc/gp4yh47j]. 8 id. 9 see david a. hyman & charles silver, five myths of medical malpractice, 143 chest j. 222 (jan. 2013), available at http:// www.americanbar.org/content/dam/aba/administrative/medical_liability /five_myths_of_medical_malpractice.authcheckdam.pdf [https:// perma.cc/frs4-4rvl]. http://dx.doi.org/10.1378/chest.12-1916 2016 371 sixteen myths of medicine and medical malpractice case outcomes to weed out the bad doctors.” i assume you would not be checking into that hospital any time soon. or think about your own experience and observations when it comes to driving. we have a tort system for resolving negligence issues arising out of driving automobiles and trucks. does it weed out bad drivers? the third way is by taking a hard look at the reality of the tort system as it applies to medical negligence. the myth appears to envision something like this: doctor commits malpractice, gets sued, loses, makes malpractice insurer pay, becomes uninsurable, and has to leave practice— all in short order. contrast that with reality. if there is any hope for a financial recovery by the patient, all of the following factors must be present: negligence is provable; damage to the patient is provable; the patient has the knowledge and the will to pursue the matter; the patient has a lawyer willing and able to pursue the case; the doctor has insurance; the patient and lawyer have the patience and the financial resources to pursue the matter for what may well be many years; a judge or jury finds negligence and awards damages; and the doctor becomes uninsurable and therefore retires from practice. how likely is all of that? myth vii: when a case goes to trial, there is a winner (other than the attorneys) that parenthetical is not meant to demean the role of attorneys in professional negligence cases. i put it in because i want to focus on the plaintiffs and defendants. we typically talk as though there is a winner and a loser in a negligence trial. even we lawyers use those terms. but i contend that, in practical terms, there generally are not any true winners. let’s start with a plaintiff’s platonic ideal. assume that a patient is damaged by a doctor’s professional negligence, that $1 million is an accurate measure of the damage, that the judge or jury finds liability and awards precisely that amount, that the doctor has insurance or resources to cover the award, and that the plaintiff is promptly paid in full. 372 indiana health law review vol. 13:2 the next morning’s newspaper would report that the patient had “won” the case and was $1 million richer. but is that really the case? let’s look a little deeper. we know that his damage was $1 million, and so was the award. chances are overwhelming that the patient owes his lawyer anywhere from $300,000 to $400,000, plus expenses in the five figures. and the process has likely taken years—maybe as many as ten. so in this best (for the plaintiff) case scenario, the plaintiff has debits of at least $300,000 in legal fees, say $25,000 in costs, and say $60,000 in loss of use of the money (at 6% a year). in other words, in the best case scenario, the so-called winner receives $615,000 in return for a $1 million loss. he can’t afford many more such “wins.” now let’s look at the best case scenario for a doctor. he wasn’t negligent and a judge or jury says so after years of effort, distraction, embarrassment, and anxiety. what does he get at the end of the ordeal other than an end to it? it is true, i will acknowledge, that if a patient takes home more of a damage award than the combined value of his actual damage and the cost of pursuing the matter, he is in a sense a “winner.” conversely, the doctor who is vindicated, regardless of his negligence actually harming a patient, may have won something. although the tort process is in itself a heavy price for a defendant. but the reality is that these extremes rarely occur. the hurdles for plaintiffs are simply too numerous and too high to allow very many instances when they truly come out ahead of the game. and the doctor whose malpractice seriously harms a patient? if the patient pursues a civil action, chances are small that the doctor will survive the ordeal without some finding of liability. if the doctor avoids liability, it’s probably because the patient didn’t—or couldn’t— pursue the matter. if the patient sticks with it, the doctor will in all likelihood be held to some degree of liability. myth viii: juries award more money than judges i have to start discussion of this myth with the acknowledgment that i have no experience and little 2016 373 sixteen myths of medicine and medical malpractice information about medical malpractice awards outside the state of indiana. all i have to say is based on indiana. let’s start by stating the myth. the myth persists that juries generally award more than judges—that juries become enflamed by emotion and outrage and award enormous, jawdropping sums. remember the climactic scene in the verdict, starring paul newman? so enflamed was the jury by the perfidy of the defendant hospital (represented by a sneering james mason) that they asked the judge, “are we allowed to award more than the plaintiff asked for?” that happens in hollywood. it doesn’t happen in indiana. in indiana juries tend to be very conservative—even stingy— in calculating awards. and that’s when they find the malpractice defendant liable. i know of cases where the jury found the doctor or hospital liable and then awarded damages equal to the patient’s medical bill—not a penny more. in cases like that no judge would have awarded less that the jury. that’s why in certain kinds of medical malpractice cases, experienced plaintiffs’ lawyers prefer that a judge rather than a jury calculate the damages. myth ix: a hospital-acquired infection must be the hospital’s fault as we’ve discussed, the term “hospital-acquired infection” is well accepted and well-known. but the term isn’t always well understood. the definition of the term is self-evident. a hospitalacquired infection is an infection that the patient acquired in the hospital. it is distinguished from a community-acquired infection, which is acquired somewhere outside the hospital. hospitals are required to track and report their hospitalacquired infection rates. the rates are published and hospitals are punished financially for high rates. but are hospital-acquired infections always the hospital’s fault? not necessarily. first, let us look at the distinction between hospitaland community-acquired infections. most indiana counties have only one hospital, and that hospital may be among the largest employers in the county. it is not unusual for a hospital cafeteria to be a popular community gathering place at mealtime, especially lunch. when the 374 indiana health law review vol. 13:2 cafeteria is full of local residents at lunchtime, is there a clear difference between the hospital and the community? i am not sure there is. now let us turn to fault. and let us exclude the lunchtime crowd from the calculus. a typical patient has visitors, generally relatives and sometimes others. in pediatric area, it is almost a given that family members will visit a patient, frequently staying around the clock. and especially with the youngest children, the family has a significant role in caring for the child, providing comfort and assisting with eating and toilet needs. if a patient acquires an infection from contact with a family member or other visitor, is it always the hospital’s fault? doesn’t the family member or other visitor share at least some part of the responsibility? myth x: unexpected readmission is evidence of poor treatment this myth not only persists, but gains momentum every day: the myth that the unexpected readmission of a patient to the hospital is proof that the care during his earlier stay must have been inadequate. so in recent years insurance programs, led by medicare, have begun to refuse to pay for the readmission stay. the theory is that the readmission would have been unnecessary if the treatment had been adequate first time around. a hospital suffers from readmissions in two different ways. first, as noted above, it may not get paid for the second stay. second, its readmission rate is published online, and it suffers from the adverse publicity. but let’s examine the myth. it is based on the premise that no factor other than poor hospital treatment could possibly contribute to the need for readmission. that premise defies common sense and general experience. what if the patient did not take the medicine prescribed by the doctor? what if he could not afford it? what if he could not get to the pharmacy? what if he did not keep his incision wound clean? what if he ate or drank things his doctor warned him against? in short, are there not countless factors outside the hospital’s control that might have contributed to the need for readmission? 2016 375 sixteen myths of medicine and medical malpractice you have probably noted that many of these factors outside the hospital’s control are related to a patient’s financial resources—or, more precisely, a patient’s lack of financial resources. so you will not be surprised to learn that studies of the issue invariably reveal that the unexpected readmission rates for hospitals in low-income areas is higher than the rates in high-income areas.10 you might say that in certain areas and with certain population groups, unexpected readmissions are not unexpected. yet the myth persists that an unexpected readmission is proof of poor hospital care. it is a little like saying that an undernourished child is proof of a poor school cafeteria. myth xi: a low cap on damages reduces plaintiff recoveries when we talk about tort reform, we generally make the uncritical assumption that a cap on damages—that is, a legal limitation on the amount—will necessarily result in lower recoveries by plaintiffs. and, of course, it is undeniably true that a cap will result in lower recoveries in some cases. what is a myth, though, is the belief that a cap will result in lower recoveries in all cases. in fact, as we shall see, there is evidence that a cap will actually result in higher recoveries in some cases—and higher average recoveries overall. let’s take a look at indiana’s cap. indiana has long had the lowest cap of all states. that’s what happens when a state elects a physician as its governor, as indiana did in 1972 with the election of dr. otis bowen, later united states secretary of health & human services. indiana’s cap currently limits a health care provider’s liability for an incident of medical malpractice to $250,000; and it limits a plaintiff’s recovery to $1,250,000.11 you are wondering, “if the doctor’s liability is limited to $250,000, how can the plaintiff receive $1,250,000?” the explanation 10 see, e.g., joel s. weissman et al., the impact of patient socioeconomic status & other social factors on readmission: a prospective study in four massachusetts hospitals, 31 jstor 163, 169 (1994). 11 ind. code § 34-18-14-3 (2016). 376 indiana health law review vol. 13:2 lies in the indiana patient compensation fund (“the fund”): a state-run insurance program that can pay the difference between the defendant’s obligation and the $1,250,000 limit. in 1991 professors eleanor kinney and william gronfein published the results of an exhaustive study of the first ten years of experience under the indiana cap on malpractice liability. the results were eye-opening. indiana plaintiff recoveries in large-claims cases (defined back then as $100,000 or more) actually exceeded large-claim recoveries in neighboring ohio and michigan—larger states with no caps.12 what is the explanation? how can a damage cap cause recoveries to go up? the answer appears to be that in largeclaim cases the limit on a provider’s liability (currently $250,000, but only $75,000 at the time of the kinneygronfein study) encourages an insurer to effectively concede liability for an amount up to, or exceeding the limit on, the insured’s liability, leaving the excess for the fund to pay and saving the insurer from further costs of defense. so, paradoxically, a cap can—and does—often increase plaintiff recoveries. myth xii: there is such a thing as a never event most of the myths we are discussing are old. they have been around as long as anyone can remember. this is a new one. it sprang up almost overnight, and it spread like wildfire. in fact, it is still spreading, with more and more events classified as “never events.” the term was introduced in 2001 by ken kizer, m.d., former chief executive officer of the national quality forum.13 the term was meant for truly shocking events— e.g., surgery on the wrong patient—that should never occur. over time, the list of events has expanded. medicare now lists 29 “never events” and often declines to pay for care that 12 eleanor d. kinney & william p. gronfein, indiana’s malpractice system: no-fault by accident?, 54 law & contemp. probs. 169, 182 (1991). 13 see, e.g., never events, agency for healthcare research & quality (dec. 2014), http://psnet.ahrq.gov/primer.aspx?primerid=3 [https://perma.cc/e72t-arah]. http://dx.doi.org/10.2307/1191858 2016 377 sixteen myths of medicine and medical malpractice involves such events.14 other insurance carriers have joined in, also declining to pay for never events. many states have adopted requirements that hospitals report events of the sort that appear on never event lists. there is no doubt that every event on the list is unfortunate and regrettable. none of them should occur, and hospitals should do their utmost to prevent them. but i maintain that it is wrong to claim that all of them are always avoidable or that a good hospital—even an excellent hospital—can always avoid all of them. let us consider a few examples: physical assault of a patient or staff member in the hospital or on the hospital grounds, serious injury of a patient from a fall, certain pressure ulcers acquired in the hospital, and serious injury from a medication error. all of these are regrettable. but can a good hospital always avoid them? let us start with physical assault. if a hospital is open to the public for 24 hours a day, how can it assure that no patient or staff member will ever be physically assaulted in the hospital or on the hospital grounds? if it can, why have all institutions in all industries not taken the same steps? or patient falls. people fall down. old, sick, and medicated people are particularly susceptible to falls. hospitals are forbidden to apply physical restraints to patients. how, then, can all falls be prevented? or pressure ulcers bed sores in common parlance. some studies show that when a mature adult lies motionless for two hours or more skin breakdown starts to occur.15 so what happens when a seventy-year-old lies motionless on an operating table for four or more hours? you guessed it. take a look at the mayo clinic’s published list of factors contributing to bed sores. it describes a large proportion of medicaid and medicare patients who find themselves in the 14 id. 15 see factsheet: skin breakdown and pressure ulcer prevention in persons with sci, rehabilitation research and training center on secondary conditions in the rehabilitation of individuals with spinal cord injury (2012), http://sci-health.org/rrtc/publications/ pdf/skincare-factsheet.pdf [https://perma.cc/zep6-fkdv]. 378 indiana health law review vol. 13:2 hospital: old age, weight loss, poor nutrition, incontinence, smoking, and dry skin.16 let’s complete our review with medication errors. two primary factors assure that even excellent hospitals will experience medication errors. one is the emergency, not-amoment-to-spare, nature of some hospital work. that kind of situation is most likely to occur in the emergency department. it also occurs, however, in inpatient areas when emergencies arise. sometimes hospital personnel need to act first and carefully consider the matter later. that may be unfortunate, but it is reality in a hospital. the other factor contributing to medication errors is the sheer number of times medications are administered. it may simply be impossible for humans to do anything a million times without an error. does a million sound like too high a number? just consider a hospital with 200 beds. assume each of the 200 patients needs medications five times a day. that’s 200 x 365 x 5, or 365,000 doses a year. but that is not the total number. each medication has been prescribed by a doctor, prepared or sent by the pharmacy, delivered from the pharmacy area to the nurses’ station, and administered by a nurse. that is four separate stepswith each involving four or more separate people. if it is four, then we can multiply our initial 365,000 by that number, for a total of nearly 1,500,000. it is hard for human beings to do anything 1,500,000 times a year without a single error. even with 99.9% accuracy, there would still be 1,500 errors. so these events cannot really be never events. they are unfortunate and hospitals should do all they can to avoid them. but they will continue to occur. myth xiii: an insurer should have low administrative costs i apologize in advance for this one. it’s inside baseball. if you look at a performance report on a liability insurance carrier, one of the factors you always see is a comparison of 16 see bedsores (pressure sores), mayo clinic (dec. 13, 2014), http://www.mayoclinic.org/diseases-conditions/bedsores/basics/riskfactors/con-20030848 [https://perma.cc/3krp-uhlf]. 2016 379 sixteen myths of medicine and medical malpractice the amount it pays to resolve liability claims—judgment and settlement payments—to all other expenses, i.e., administrative costs. and the prevailing wisdom is that a high proportion of administrative costs is a bad thing—an indicator of inefficiency. at first glance, this conventional wisdom sounds right. let’s take a closer look. what if a health system operates its own captive insurance program, spends a high amount on risk management and risk reduction strategies, and as a result pays only a very modest amount in claims settlements? the arithmetic would show a high proportion of administrative costs. but would that be a bad thing? i don’t think so. myth xiv: there’s an answer to, “should physicians apologize for medical errors?” i have spoken and published articles on the subject of the role of physician apologies in resolving cases professional negligence. often, in discussions of the subject, people ask me the question posed on the screen: “should physicians apologize for medical errors?” to me, that’s a little like asking, “should parents send a child to a private school?” the only accurate answer is, “it depends.” let’s first discuss why there is not one answer to the question. later i’ll give you my own general view on a matter that is hard to generalize about. why is there not a one, onesize-fits-all answer? first, consider the most basic variables in any one case. was there an error? that is harder to answer than you might think. it’s common for experts to disagree on that fundamental matter when, say, a case is reviewed by a medical review panel. that is, of course, why in indiana we use a panel rather than a single expert. next, does the error really reflect fault? or did the error occur despite the provider’s adherence to the standard of care appropriate to the circumstances? next, was there damage to the patient? it is a fact— fortunately—that most errors in a hospital do not cause any significant harm or any harm at all. most are never even detected. in my earlier hypothetical about the 200-bed hospital, we found 1,500,000 separate actors annually in 380 indiana health law review vol. 13:2 medication administration alone: opportunity for more than a few errors. most of those errors are never discovered. finally, if there was damage, what was the extent of it? did the damage leave the patient disabled for life? dead? or was it a bedsore that healed in two weeks? now, one more difficult and sensitive question: assuming we can answer all the previous questions the way the plaintiff wants them answered, who was responsible? was it really the defendant? remember that in the context of hospital care, medicine is a team sport. if, for example, the incident occurred in surgery, team members might have included one or more surgeons, two or more nurses, an anesthesiologist, maybe one or more residents or fellows, one or more technicians, and that always-present team member, the facility itself. so whose fault was it? or, in terms of the question on the screen, who should do the apologizing? do we really want the surgeon to say to the plaintiff, “i want to apologize for the incompetence of the circulating nurse?” myth xv: an apology necessarily involves admission of liability according to conventional wisdom, a physician can’t apologize for a medical error without admitting responsibility for it. therefore, a physician shouldn’t apologize for an error because doing so would make him liable for the damage to the patient. but, as a linguistic matter, an apology can be separated from an acceptance of responsibility. and interestingly, some states have adopted rules of evidence that turn on that separation. since 2006 our own state, indiana, has distinguished between a “communication of sympathy” and a “statement of fault.” the former is inadmissible in evidence. the latter is not.17 assume, for example, that a surgeon said to a plaintiff, “i am very sorry your husband died on the operating table; i was at fault.” the first independent clause would not be admissible in evidence, but the second one would be admissible. 17 ind. code § 34-43.5-2-4 (2016). 2016 381 sixteen myths of medicine and medical malpractice in contrast to indiana, colorado would make the surgeon’s entire statement inadmissible. the colorado statute says that in a civil action arising out of an “unanticipated outcome of medical care,” all of the following are inadmissible: all statements made by a health care provider “expressing apology, fault, sympathy, commiseration, compassion, or a general sense of benevolence.”18 so in terms of the words on the screen, both states make a distinction between an apology—or at least, an expression of sympathy—and an admission of liability. indiana makes one inadmissible and the other admissible. colorado distinguishes between the two but makes both inadmissible. myth xvi: apologizing for medical errors is always a mistake you have probably guessed from my last couple of points how i feel about the issue on the screen. let me start with my conclusion and then explain how i got there. my conclusion is that there’s no single, one-size-fits-all answer; but sometimes—even often—an apology can actually be a good idea for the physician or the hospital. there is by no means a wealth of evidence on the effects of disclosure and apology for medical errors. but the evidence that exists points to the conclusion that physician apologies decrease both the incidence of lawsuits and size of awards to patients. in 1987, the veterans administration (va) hospital of lexington, kentucky, instituted one of the earliest formal disclosure policies. a study over a seven-year period (1990—96) revealed that, compared to the other 35 va hospitals in the eastern united states, the lexington va hospital was in the top quartile in the number of claims filed but the bottom quartile in the amount of payments.19 in 2002 the university of michigan health system launched a program that, among other things, called for 18 col. rev. stat. § 13-25-135 (2016). 19 steve s. kramer & ginny hamm, risk management: extreme honesty may be the best policy, 131 ann. intern. med. 963, 963 (1999); see also albert w. wu, handling hospital errors: is disclosure the best defense? 131 ann. intern. med. 960 (1999). http://dx.doi.org/10.7326/0003-4819-131-12-199912210-00010 http://dx.doi.org/10.7326/0003-4819-131-12-199912210-00012 382 indiana health law review vol. 13:2 prompt acknowledgement of errors and prompt compensation to patients. from august 2001 through august 2005, the average number of open cases declined from 260 to 114. annual litigation costs dropped from approximately three million dollars to one million dollars.20 we generally assume that the victim of negligence is motivated primarily—even exclusively—by the desire for money. but that’s not what the research shows. according to lucian l. leape, m.d., of the harvard school of public health, what the typical patient most wants—more than money—is that the physician (a) acknowledge the error and explain it, (b) take responsibility and apologize, and (c) discover the underlying cause and take steps to prevent recurrence.21 similarly, professor carol b. liebman of columbia law school, and chris hyman, of the medical mediation group in new york city, report that what patients most want—more than money—are (a) basic information about the incident, (b) an apology, and (c) prevention of recurrence of similar incidents.22 these two studies are consistent with studies of why patients sue their physicians. the primary reasons are (a) the perception that the physician wasn’t honest in addressing the incident, (b) the perception that no one would explain what happened, and (c) the receipt of advice from someone (often another health care provider) to sue.23 now consider the several disclosure requirements that already obligate a physician and a hospital to disclose a medical error to the patient. the american medical association has long held that a physician has an ethical duty to disclose a harmful error to the patient.24 and the joint 20 hillary r. clinton & barack obama, making patient safety the centerpiece of medical liability reform, 354 new eng. j. med 2205 (2006). 21 lucian l. leape, understanding the power of apology: how saying ‘i’m sorry’ helps heal patients and caregivers, 8 focus on patient safety found. 1 (2005). 22 carol b. liebman & chris s. hyman, a mediation model to manage disclosure of errors and adverse events, 23 health aff. 22, 24 (2004). 23 id. see also id. at 23 n. 9, where liebman & hyman identify multiple studies on physician mistakes and subsequent behavior that prompt malpractice claims. 24 am. med. ass'n, principles of medical ethics i-iv (2001); am. med. ass'n, code of medical ethics, opinion 8.12 (2007). http://dx.doi.org/10.1056/nejmp068100 http://dx.doi.org/10.1377/hlthaff.23.4.22 2016 383 sixteen myths of medicine and medical malpractice commission, the major hospital accreditation authority in the united states, has for years required hospitals to disclose harmful medical errors, including the requirement that the disclosure be made by the “responsible physician (or a designee . . .).”25 so i ask you, in light of the apology statutes, results of these studies, and the disclosure requirements that the ama and the joint commission already impose, isn’t it reasonable to conclude that in many cases an apology is the best course of action? conclusion thank you for giving me the opportunity to identify what i regard as medical myths. i’ve been waiting my entire professional life for the chance to complain about them. you’ve given me that chance. 25 see, e.g., the joint comm'n, hospital accreditation standards, ethics, rights, and responsibilities. indiana health law review volume xvi 2018 number 1 note everyone hates going to the dentist! are dental service organizations taking the bite out of managing a dental practice in indiana? karri l. meldrum* i. introduction as with most beautiful summer days at local state fairs, the smells and sounds of celebrating summertime would entice most people to munch on some yummy caramel corn or taste the latest salt-water taffy flavors. upon doing so, one fairgoer in particular regrets the decision to indulge in such tasty delights as they feel a surge of pain shoot through one of their teeth as they bite down. immediately, feeling the injury with their tongue, a portion of their tooth has sheared off and they instantly know–it is time to see their dentist. as the pain sharply increases, the main concern for this unfortunate fairgoer is how quickly they can access a dentist and how much is this going to cost them. after a few phone calls to check appointment availability, the fairgoer strikes gold: a nearby dentist has an opening the same day! soon they are patiently sitting in the waiting room of a nicely decorated dental office, holding an ice pack to their jaw for some temporary relief. upon looking around, the office is organized, extremely clean, and welcoming. the waiting room has a tv with dental education videos playing, free wi-fi, and professionally designed marketing materials. it truly looks like this dentist really knows the business side of owning and operating a dental practice. as the pained patient sits in the waiting room, thoughts of who actually owns this dental practice enter their mind as they are pretty sure they have seen commercials for similarly designed practices. who actually maintains and runs this practice–is it even this dentist? is this practice owned by an entrepreneur who is not a dentist? if a person goes to a fine restaurant, most people do not ask the highly skilled chef if they own the establishment; in fact, most chefs do not, and yet the food is usually amazing; is this the same type of situation? thoughts of quality, safety and the legality of a non-dentist owning a dental practice enter the injured fairgoer’s mind. * j.d. candidate, 2019, indiana university robert h. mckinney school of law; m.b.a., 2011, minnesota school of business; b.s., 2008, minnesota school of business. http://doi.org/10.18060/3911.0058 148 indiana health law review [vol. 16:147 a. the issue the control of the practice of medicine, including dentistry, is wellestablished among lawmakers. volumes of regulation regarding medical and dental graduation requirements, the scope of practice, drug prescribing, and patient privacy laws, just to name a few, are heavily enforced in each state. whatever the deemed area, government agencies are happy to step in and regulate, even if they are not regulating an actual medical or dental function. proposed legislation is at issue for the recent rise of a newer type of business management company, which some states believe falls within the dental scope of practice and therefore must be regulated. this type of business is called a dental service organization (“dso”) and recently has become a controversial issue for many state legislatures. a dso is not a dentist (although dentists can be part of the management team), but rather a group of individuals with business backgrounds and entrepreneurial drive who run the administrative duties of a dental practice.1 dsos contract with dentists to provide business services in their dental practices; the end goal is for the dentist to be able to focus on dental work while the hired dso can focus on the administrative work.2 for example, dsos usually provide such administrative services to the dentist s information technology, marketing, human resource management, supply chain management, financial support, legal team access, and repairs and maintenance, while the dentist focuses on clinical procedures with the patient.3 the issue is if the dentist hires a management company to help them with their business affairs, why is the government and its agencies stepping in and trying to regulate the private management company? this note will argue and delineate between the services a dentist provides, which are and should be regulated, and the services a dso provides, which should not be regulated. another issue to consider is the health and welfare of the patients affected by dsos in states that allow operation of such management companies. if a state legally allows dsos to operate within their borders, are patients better taken care of? customarily, the iron triangle of healthcare—access, cost and quality—is “used to assess healthcare systems of all kinds.”4 this note will thoroughly examine and argue that dsos do improve access for patients, help control costs through leveraged bargaining, and improve the quality of patient care through standardized training practices. 1. about dsos, ass’n dental support orgs., http://theadso.org/about-adso/dso-industry [https://perma.cc/nzt2-5wc8]. 2. id. 3. id. 4. tom godfrey, what is the iron triangle of health care?, penn square post (mar. 3, 2012), http://pennsquarepost.com/what-is-the-iron-triangle-of-health-care/ [https://perma.cc/q9mlfk5q]. 2018] everyone hates going to the dentist! 149 b. roadmap this note discusses the upsurge of the dso in various states and addresses whether they should be government regulated and how some states have treated this recent management style. section ii discusses the background of the corporate practice of medicine and how it applies to dentistry. this section also shows the historical trends of solo dental practices versus dso managed practices and includes arguments for and against dsos. the background section will illuminate the need for this note, as it will show dsos are here to stay and highlight the significant impact dsos are making in the dental market. section iii will discuss a national sampling of how some states have already begun to regulate dsos within their borders. this sampling includes heavily regulated states, states with some regulation, and states with virtually no regulation. section iii will provide an in-depth analysis of the indiana statutory language regulating dsos. section iv will look at the impact of states that already have the presence of dsos within their borders. specifically, looking at the iron triangle, this section analyzes how dsos provide better access to dental care, how costs are lowered, and how quality is improved. section v concludes the note, with a summary and delineation of dentist responsibilities versus dso responsibilities. with the issue being clearer, this note argues throughout that statutory regulation for administrative duties in a dental office is not needed. last, for states that have dsos, regulated or not, the benefits outweigh any proposed negatives, and states need to allow these types of business management companies to function like other business entities within their borders. ii. background of the issue a. the corporate practice of medicine and its application in dentistry for most in the medical community, it makes sense that there are laws limiting the practice of medicine to licensed individuals who graduate from credentialed institutions.5 these types of laws are often codified in state licensing laws or in common law doctrine and are collectively known as the corporate practice of medicine (“cpm”) doctrine.6 in the early 1900s, the cpm doctrine was largely used to prevent companies from hiring physicians to care for workers in factories.7 today, the cpm doctrine still has a profound effect on a corporations’ ability to hire physicians. although there are benefits and efficiencies of medical group practices, “many believe that when corporations entangle themselves in the practice of medicine and are in a position to control 5. jennifer brunkow, 3 steps to navigate through the corporate practice of medicine, becker’s hosp. rev. (mar. 26, 2012), https://www.beckershospitalreview.com/legal-regulatoryissues/3-steps-to-navigate-through-the-corporate-practice-of-medicine.html [http://perma.cc/v44h3eal]. 6. huberfeld et al., the law of american healthcare 507 (2017). 7. id. 150 indiana health law review [vol. 16:147 physicians’ compensation, they may also negatively influence patient care.”8 a state will use its cpm doctrine to regulate four main areas: 1. some states prohibit business entities from employing physicians to provide medical care. 2. certain states require entities that provide medical services be owned and operated by licensed medical doctors. 3. some states prohibit professional fee splitting between licensed medical professionals and non-licensed individuals or business entities. 4. the management fees stated within management services agreements must be set at fair market value.9 in most states, there are a number of exceptions to the cpm doctrine. the most widely known exception is that of hospitals. in the 1997 berlin v. sarah bush lincoln health center case, the supreme court of illinois held that “a dulylicensed hospital possesses legislative authority to practice medicine by means of its staff of licensed physicians and is accepted from the operation of the corporate practice of medicine doctrine.”10 although a common thought today, the concept of hospitals employing doctors was quite a leap from the stoic days of the early 1900s, where no layperson could possibly employ a physician. this leap has also occurred in the dental realm, but in a much quieter fashion. dentistry falls under the umbrella of a state’s cpm doctrine because dentists are considered health care providers. for example, in 2010, the u.s. department of health and human services (“hhs”) released a health insurance portability and accountability act (“hipaa”) information sheet discussing a list of providers who must follow the updated hipaa policy.11 under the section of who must follow the law, the answer was “[m]ost health care providers. . .including most doctors, clinics, hospitals, psychologists, chiropractors. . .and dentists” must follow all new hipaa regulations.12 therefore, given that dsos are not hospitals, it becomes apparent that they are illegal in every state adopting cpm policies. in other words, the law looks bleak for a layperson (a non-dentist) owning and operating a dso. keeping this in mind, how are there mega dsos like heartland, aspen, kool smiles, and pacific dental, just to name a few, operating in states that have a cpm doctrine in place? simply put, some state legislatures have stepped in and added to their existing cpm laws exceptions so that dsos can operate within their boundaries. these exceptions, warranted or not, have been and currently are the controversial issues on many state legislature floors and are further discussed in the statutory analysis section below. 8. brunkow, supra note 5. 9. id. 10. berlin v. sarah bush lincoln health ctr., 179 ill. 2d 1, 19 (1997). 11. what is hipaa?, off. for c.r., u.s. dept. health & human serv., https://medicalboard.iowa.gov/images/pdf/hipaa.pdf [https://perma.cc/q63m-sbxd] (last updated aug., 2010). 12. id. 2018] everyone hates going to the dentist! 151 b. the dental field follows the medical field: a look at consolidation business consolidation is common practice these days: “[c]onsolidation in the general economy is occurring more often . . . lately, the economy has experienced a wave of consolidations in the banking industry, retail sales organizations and in the automobile manufacturing and airline industries.”13 the healthcare sector has also seen consolidations, specifically in the early 1990s with the development of management service organizations (“msos”) for doctors, and then again in the late 2000s with large-scale employment by hospitals.14 medicine leads the way in the health care field and predicts what other health care professionals will be doing ten to twenty years down the road.15 it is common news these days that small and large hospitals are consolidating to ensure future viability.16 in fact, all types of medical facilities are consolidating or already have consolidated to save on costs and improve patient care.17 in october of 2015, the u.s. department of veterans affairs consolidated their medical programs in order to improve access to care.18 in a recent 2015 study, only 17% of today’s physicians are in solo practice, compared to 54% in 1980.19 doctors who described themselves as solo practitioners dropped from 62% in 2008, to the dramatic figure of 35% in 2014.20 physicians who are employed by hospitals or medical groups increased from 38% to 53% over the 2008-2014 period.21 the same type of consolidation is happening now in dentistry.22 solo dental practices are shrinking at an unprecedented rate; “[a]ccording to the american dental association, solo practices represented 68% of all dental practices in the u.s. in 13. albert guay et al., considering large group practices as a vehicle for consolidation in dentistry, am. dental ass’n, 2, (apr. 2016), http://www.ada.org/~/media/ada/science% 20and%20research/hpi/files/ hpibrief_0416_1.pdf [https://perma.cc/643j-aunb]. 14. id. at 3. 15. steven j. holm, the changing face of dentistry, 94 j. ind. dental ass’n 6, 7 (2015), http://www.jida.news/jida2015winter#page=6. 16. indiana health system and hospital complete merger, becker’s hosp. rev. (jan. 7, 2010), https://mail.beckershospitalreview.com/news-analysis/indiana-health-system-and-hospitalcomplete-merger.html [https://perma.cc/sp6q-8wp4]. 17. plan to consolidate programs of department of veterans affairs to improve access to care, u.s. dep’t veterans aff. (oct. 30, 2015), https://www.va.gov/opa/publications/va_ community_care_report_11_03_2015.pdf [https://perma.cc/wn6b-3sdd]. 18. id. 19. richard gunderman, will independent physicians go extinct?, the health care blog (apr. 1, 2015), http://thehealthcareblog.com/blog/2015/04/01/will-independent-physicians-goextinct/ [https://perma.cc/7kw4-lhxe]. 20. id. 21. id. 22. is dental following medical?, planet dds (oct. 28, 2015), https://www. planetdds.com/2015/10/28/is-dental-following-medical/ [https://perma.cc/sr57-qeby]. 152 indiana health law review [vol. 16:147 2014, down from 76% in 2008.”23 dentists are choosing to practice with groups and dsos rather than taking the risk of trying a solo dental practice and “[t]his trend appears to be pronounced among recent dental school graduates who don’t want to deal with the business aspects of running a practice and would prefer to focus exclusively on patient care.”24 in a recent 2017 report, the growth and market share capture of dsos is becoming very obvious.25 according to the american dental association (“ada”), while dsos have an annualized growth rate of 14%, solo practices are becoming less and less common, shrinking at a growth rate of 7% per year.26 in the same report, it is predicted that dsos will continue to grow at 15% annually over the next five years, making market share at 30% by 2021.27 understanding the trends of the medical field, and how the dental field usually follows close behind in these trends, is critical to this note because, legally, one could predict with some degree of accuracy how group practice dentistry—the dso—will be treated. when states first adopted the cpm doctrine, there was a general sense of negativity towards the doctrine.28 then, with the expansion of medical conglomeration, there was also widespread negativity towards corporate medicine.29 over time, and with experience and strategies in place, physicians and state legislatures became friendlier towards the idea and even saw some positive outcomes from consolidation.30 one could then also predict that public opinion will shift in favor of dsos in the dental arena.31 this is a key part of the issue at hand because dental consolidation is newer, and there are those who are opposed to the idea and think regulation is the key.32 dr. steven holm, dds, former president of the indiana dental association, said, “i am not opposed to large group practices…i think there will be a place for both solo practices and large group practices to succeed side by side. first, however we must tear down the fences.”33 dr. mark cooper, dds, shared that, “most dentists and their political organizations are resisting the obvious—that dsos are the future. rather than figuring out how to optimize their values and assets within 23. id. 24. id. 25. marc cooper, why the future is dsos, dpr’s mod. dental network (apr. 19, 2017), http://practicemanagement.dentalproductsreport.com/article/why-future-dsos?page=0,0 [https://perma.cc/n9cg-fseq]. 26. id. 27. id. 28. brunkow, supra note 5. 29. id. 30. id. 31. holm, supra note 15. 32. sound off: the dental community talks ‘corporate dentistry’, dentistry iq (apr. 7, 2016), http://www.dentistryiq.com/articles/apex360/print/volume-3/issue-4/special-focus-corporateden t is t ry-2 -0 / sou n d-of f -t h e -den ta l-com munity-talks-corporate-den t is t ry.h tml [https://perma.cc/7323-zjg9]. 33. holm, supra note 15. 2018] everyone hates going to the dentist! 153 a dso ecology, most dentists are up in arms about dsos, trying to stop their growth and expansion and digging in their heels.”34 dr. holm pleaded in his article, “if you look at history…dentistry always follows medicine—always. bottom line is we need to talk.”35 let the discussion truly begin. c. why states want to regulate dsos as briefly discussed, dsos have non-dental—also known as nonclinical—functions.36 dsos provide “critical business management and support including non-clinical operations.”37 some of these operations include human resource management, information technology services, supply chain management, bill payment and financial services, operation management, and revenue cycle services. these services are provided to the dentist in a few ways. first, a solo-practicing dentist could hire a dso via contract to help manage their practice. second, a group of individuals could form a company and hire dentists as their employees, building and acquiring practices through mergers or new practice build outs. depending on the state laws the company is operating in, the dso may have a professional service agreement with a licensed dentist in that particular state.38 third, in combination of the first two services, a solo practice dentist could sell their non-clinical assets to the dso and become their employee.39 whichever method is chosen, the dso has the same role each time, which is non-clinical management of the practice’s business aspects.40 in contrast, a solo dentist without a dso will perform: patient examinations, treat diagnosed issues, teach prevention, find or attend training for licensure, and perform all the management duties needed to run a successful business.41 dentists will have to “hire, evaluate, promote and fire employees including . . . receptionists, dental hygienists and assistants…order equipment and supplies for the practice . . .check bookkeeping and accounting and handle tax, paycheck and insurance payments, as well as pay for repairs and maintenance of their offices.”42 dentistry has one of the highest suicide rates among professionals.43 one 34. cooper, supra note 25. 35. holm, supra note 15, at 7. 36. about dsos, supra note 1. 37. id. 38. see kevin cain, what you should know about dsos, drbiscuspid.com (june 29, 2015) http://www.drbicuspid.com/index.aspx?sec=ser&sub=def&pag=dis&itemid=318109 [https://perma.cc/jdu8-8q9p]. 39. id. 40. about dsos, supra note 1. 41. irene blake, general dentist’s duties, chron, http://work.chron.com/general-dentistsduties-11094.html [https://perma.cc/g5dp-s67n]. 42. id. 43. top 11 professions with highest suicide rates, mental health daily, http://mentalhealthdaily.com/2015/01/06/top-11-professions-with-highest-suicide-rates/ [https://perma.cc/4mqm-y2yd]. 154 indiana health law review [vol. 16:147 contributing factor may be the balancing act a solo dentist has to do each day trying to administratively run their dental practice yet still focus on the clinical patient side.44 it makes sense that a dentist would want to shed some of this stress by hiring a dso or become an employee of a dso. so what is the real conflict then? similarly, when the medical community started to consolidate, “there [was] a bias among some towards those that work in large group practices, that this business concept is less than ideal.”45 as experts in business, dsos have been accused of focusing on the bottom line rather than the patient in the chair.46 the conflict occurs between a dentist and a dso because dentists are typically paid based on what they produce, so to be paid higher wages, a dentist might feel the pressure “to over diagnose to meet production goals.”47 an example of this type of situation occurred in 2010, when a national chain known as “small smiles centers” was fined $24 million to resolve fraud allegations, which the department of justice said stemmed from medically unnecessary dental services performed on children.48 the company paid the fine, agreed to sign a corporate integrity agreement, and assisted “the government’s continuing investigation of individual dentists.”49 allegations of billing and procedure abuse continued at small smiles centers until the final blow occurred in 2014, when the office of inspector general notified the company they would no longer be allowed to use medicaid, medicare, or other government sponsored health programs.50 in another example, in 2012, indiana’s office of inspector general released a report investigating dentists for questionable medicaid pediatric billing practices, implying many dentists under review were from dental chains.51 no further reports were generated from the office of inspector general’s 2012 initial claim. also, as recent as january 2018, a fine of $23.9 million was announced by the department of justice against kool smiles dental clinics for allegedly submitting false claims.52 with large fines and thousands of patients being affected, questions 44. id. 45. holm, supra note 15. 46. id. 47. id. 48. national dental management company pays $24 million to resolve fraud allegations, u.s. dep’t justice (jan. 20, 2010), https://www.justice.gov/opa/pr/national-dental-managementcompany-pays-24-million-resolve-fraud-allegations [https://perma.cc/pl48-db8d]. 49. id. 50. talesha reynolds, firm that manages dental clinics for kids excluded from medicaid, nbc news (mar. 12, 2014, 12:44 pm et), https://www.nbcnews.com/news/investigations/firmmanages-dental-clinics-kids-excluded-medicaid-n50416 [https://perma.cc/5h7g-t3eu]. 51. dep’t health & human servs., questionable bulling for medicaid pediatric dental services in indiana 12 (2014), https://oig.hhs.gov/oei/reports/oei-02-14-00250.pdf [https://perma.cc/ycn5-ffpr]. 52. doj: kool smiles dental clinics to pay $23.9 million, allegedly submitted false claims, abc15 arizona (jan. 10, 2018, 6:50 p.m.), https://www.abc15.com/news/state/doj-koolsmiles-dental-clinics-ordered-to-pay-239-million-knowingly-submitted-false-claims 2018] everyone hates going to the dentist! 155 about regulations and oversight of large dental groups have certainly been addressed on most state congressional floors. big dollar fines produce big headlines, but that does not mean that all dsos are depraved and all solo dentists operate with full integrity. the dental industry should be regulated to ensure the best patient care possible so that huge headlines, like those discussed above, do not happen. these regulations should apply to all clinically related items because it is the dentist who holds responsibility for clinical decisions—not common business practices found in every industry.53 every state regulates the practice of dentistry differently, but “there exists a demarcation between clinical activities, which are regulated by a state’s dental board (or equivalent state body), and non-clinical activities which are not considered professional matters (and over which the dental board has no authority).”54 some states have done a great job at distinguishing between a clinical area and a normal business management area. a sampling of how various states have handled this type of regulation will be discussed next. iii. state dso regulations a. national sampling of state dso regulations as previously discussed, the conflict between dentist and dso regulation seems to stem from the concern of overbilling and pressures for high production to meet the bottom line.55 state regulation of dental clinical functions is appropriate, but regulation of non-clinical normal business activities, which occur in other industries, is an over-reach of regulators. in sum: state dental boards guard and enforce their existing statutes prohibiting non-licensed individuals from performing or even attempting to perform a clinical function reserved for licensed professionals. what is equally clear is that activities on the nonprofessional side of the clinical/nonclinical line do not involve the practice of dentistry and, as such, do not require a license to practice dentistry to perform. the sanctity of the clinical/non-clinical line also applies in alternative practice arrangements[.]56 states have handled the delineation of clinical dental duties versus non-clinical duties in a variety of ways, but mostly through adding to their own states corporate practice of medicine doctrines. [https://perma.cc/9pxu-eh34]. 53. ass’n dental support orgs., toward a common goal: the role of dental support organizations in an evolving profession 7 (2014), https://www.theadso.org/wpcontent/uploads/2018/04/adso-white-paper.pdf [https://perma.cc/rjl8-cl9m]. 54. id. at 9 (emphasis omitted). 55. holm, supra note 15. 56. ass’n dental support orgs., supra note 53, at 9. 156 indiana health law review [vol. 16:147 1. states with little-to-no dso regulations some states have little regulations regarding the operation of dsos within their borders. states like arizona, mississippi, new mexico, north dakota, ohio, and utah are states that permit full or partial ownership of dental practices by business entities through their corporate practice of medicine laws.57 in utah, for example, the statutory code allows dental practice through a business corporation.58 the utah legislature uses the following language to regulate dental practices: “[a] dentist licensed under this chapter may engage in practice as a dentist, or in the practice of dentistry only as an individual licensee, but as an individual licensee, he may be: . . . a lawfully formed professional corporation . . . a lawfully organized limited liability company . . . a lawfully organized business corporation . . .”59 utah code provides that there are some limitations to a non-licensed dentist to “participate in, or interfere in the licensee’s practice of dentistry.”60 utah’s language is a very good example of how the state has recognized the delineation between the clinical practice of dentistry and the normal business constructs of managing any type of company. in utah, a dentist must focus on the clinical side of dentistry and maintain their license. other business entities, including dsos, are not to interfere with the clinical decisions of the practice but can be hired to help with the day to day non-clinical operations of the practice. ohio law provides definition for occupations and professionals in relation to their cpm doctrine. ohio code provides that “a corporation may be formed under this chapter for the purpose of carrying on the practice of any profession, including, but not limited to, a corporation for the purpose of providing . . . medical and hygienic treatment of patients . . .”61 in ohio, therefore, corporations are allowed for the purpose of providing medical and hygienic services. in ohio’s revenue code, “[n]o person, being a manager, proprietor, operator, or conductor of a place for performing dental operations, shall employ a person who is not a licensed dentist to perform dental operations or shall permit such person to practice dentistry in his office.”62 all states have similar language restricting clinical practice of dentistry to licensed dentists.63 notably, however, this does not restrict a dso from operating within ohio state boundaries. finally, one of the few restrictions ohio statutes have potentially placed on dsos comes with the naming (marketing) of the dental practice. in a recent 2015 language update from 57. martin j. siegel & jim moriarty, survey of state laws governing the corporate practice of dentistry (2012), https://oversight.house.gov/wp-content/uploads/ 2012/04/4-25-12-survey-of-state-laws-governing-the-corporate-practice-of-dentistry.pdf [https://perma.cc/95c7-8pzs]. 58. utah code ann. § 58-69-804 (lexisnexis 2018). 59. utah code ann. § 58-69-804(1) (lexisnexis 2018). 60. utah code ann. § 58-69-804(2) (lexisnexis 2018). 61. ohio rev. code ann. § 1701.03 (lexisnexis 2018). 62. ohio rev. code ann. § 4715.19 (lexisnexis 2017). 63. ass’n dental support orgs., supra note 53. 2018] everyone hates going to the dentist! 157 ohio’s house bill 64, “[a]ny person practicing or offering to practice dentistry or dental surgery shall do so under the person’s name, the name of a professional association, professional partnership, corporation-for-profit, or limited liability company that includes the person’s name.”64 this language states that dentists can name their practice using their name personally or the corporation’s name, but if dentists use the corporation name, then they must also include their personal name on the business registration as well. although this is a small sampling of statutory language from states with littleto-no dso regulations, the sampling of cpm doctrine shows how most state legislatures have still considered the presence of dsos within their borders and solved the delineation issues between a clinical dental provider and a business management provider. 2. states with a moderate level of dso regulation states with moderate regulation typically have some statutory language that restricts dsos in areas that are clearly non-clinical or areas that are typically not regulated in the normal course of business. florida and indiana are good examples of moderate legislation.65 in florida, statutes provide that no person other than a dentist . . . a professional corporation or a limited liability company composed of dentists may employ a dentist or dental hygienist . . . control the use of any dental equipment or material . . . or direct, control or interfere with a dentist’s clinical judgment.66 in florida, if there are any leased dental equipment or materials involved, there must be a provision in the dso contract establishing that the dentist maintains custody and control of the equipment.67 florida code specifically addresses and prevents a non-dentist from influencing a dentist’s “independent professional judgment.”68 florida also lists items that a dso cannot exercise control over, including: selection of treatment for patients, patient records, policies and decisions for pricing, credits, refunds, warranties and advertising, along with decision relating to office personnel and hours of the practice.69 ordinary business decisions in most industries of a non-clinical nature typically include the ability to hire personnel for the office, market for the practice, and select the hours of operation. florida has made these decisions illegal and penalizes such behavior of dso operators with a third-degree felony.70 thus, if a dso in florida sets business hours for a practice from 9:00 a.m. to 5:00 p.m., the non-dentist owners could be liable for a felony in the third degree. this does seem heavy-handed, 64. ohio rev. code ann. § 4715.18(b) (lexisnexis, 2017). 65. noting that indiana will be discussed in-depth later in this note. 66. fla. stat. ann. § 466.0285 (lexisnexis, 2017). 67. id. 68. fla. stat. ann. § 466.0285(2) (lexisnexis 2017). 69. fla. stat. ann. § 466.0285(2)(a-d) (lexisnexis 2017). 70. fla. stat. ann. § 466.0285(3) (lexisnexis 2017). 158 indiana health law review [vol. 16:147 but, in florida, it is the law. 3. states with prohibitions or heavy regulation of dsos states with strict regulation or complete restriction of dsos with their borders are not that common. states that fall under the heavy-handed approach require dsos to register their business with the dental board, give increased power to their state licensing board or prohibit dsos within their borders all together. missouri, wisconsin, texas, and iowa are examples of states with increased regulations against dental management businesses. in missouri, a 2017 house bill proposal includes language that allows the state dental board to regulate dso non-clinical services, such as information technology and billing support.71 in wisconsin, a 2016 amendment prohibits a person from owning or operating a dental practice in wisconsin unless the dental practice is registered by the dental examining board.72 this bill also gives power to the state’s dental board to stop operations of any dso at any time, even if the dso had nothing to do with other events.73 dentists in the state of wisconsin who are opposed to this type of legislation claim the board is given too much unchecked power, stating they “can’t imagine a heart surgeon having to worry about payroll or if the hospitals [sic] quarterly returns are in, they have to stop focusing on patients.”74 proposals similar to wisconsin’s have recently been passed and signed into law in texas.75 as of february 2016, registration of dsos must occur annually and must disclose names, addresses, non-clinical individuals who hold more than ten percent ownership, and all support services that a dso provides to the dentist.76 the requirement of dsos to register “continues the trend in texas 71. ass’n dental support orgs., missouri state profile (2017), http://theadso.org/wpcontent/uploads/2017/05/adso-state-profile.pdf [https://perma.cc/72ar-u4n7]. see also h.b. 815, 99th gen. assemb., 1st reg. sess. (mo. 2017). 72. ass’n dental support orgs., assembly bill 368 relating to: regulation of dental practices: problems presented by assembly substitute amendment 1, http://theadso.org/download/republican-one-pager-on-assembly-bill-368/?wpdmdl=4837 [https://perma.cc/85b7-6xmh]. 73. ass’n dental support orgs., assembly bill 368 relating to: regulation of dental practices: dsos increase access to dental care and lower costs, http://theadso.org/download/democratic-one-pager-assembly-bill-368/?wpdmdl=4832 [https://perma.cc/dhd4-rk9m]. 74. tim quirt, don’t add red tape to my dental practice, wausau daily herald (nov. 10, 2015, 4:50 pm), http://www.wausaudailyherald.com/story/opinion/columnists/2015/11/ 10/don’t-add-red-tape-my-dental-practce/75514290/ [https://perma.cc/3y4s-kt94]. 75. alexis reynolds, texas to require registration of dental support organizations, mcguirewoods (jul. 23, 2015), https://www.mcguirewoods.com/client-resources/alerts/ 2015/7/texas-require-registration-dental-support-organizations.aspx [https://perma.cc/8zlwts38]. 76. id. 2018] everyone hates going to the dentist! 159 toward somewhat tighter regulation of dsos.”77 dsos are non-clinical business management companies.78 these types of services can be performed by business entity and include: bookkeeping, accounting and tax preparation, payroll administration and processing, payor relations, billing and collections, banking and financing, creation and placement of dentist approved advertising, promotion (social media), marketing, information technology, human resources, general office management, property management, housekeeping, risk management: legal and regulatory, compliance, insurance.79 regulating a dso entity to the extreme measures as discussed above, is comparable to mandating anyone southwest airlines contracts with for outside services, registers with the faa for scrutiny. regulation of clinical functions makes complete sense and fulfills the missions of state police powers under the tenth amendment, but to regulate normal industry business behavior in this manner is too intrusive and needlessly drains taxpayers’ money and government time. b. indiana regulations regarding dsos 1. first major cpm case regarding dentist practice ownership in modern times as previously stated, indiana statutory regulations tend to fall into the moderate category of dso regulation. there is both case law and statutory language that govern what a dso can and cannot do within its borders. the first indicator of change for cpm laws and dental practice ownership occurred in a landmark case in 2002, which is still valid law today.80 in the 2001 case orthodontic affiliates p.c. v orthalliance inc., ortho affiliates were a group of orthodontists who merged their professional corporation with the dso orthoalliance.81 some of the doctors became “dismayed because their profits failed to meet projections; the loss of autonomy over certain business decisions bothered others.”82 in order to get out of their practice management agreements with orthoalliance, the orthodontists sued, claiming their service agreements, merged together, violated indiana code §25-14-1-23 of the indiana dental practice act (“idpa”).83 in 2001, this section of the indiana code read: [a] person is practicing dentistry within the meaning of this chapter if the person . . . 77. id. 78. ass’n dental support orgs., supra note 53. 79. id at 9. 80. orthodontic affiliates p.c. v. orthalliance inc., 210 f. supp. 2d 1054 (n.d. ind. 2002). 81. id. at 1056. 82. id. 83. id. at 1058. 160 indiana health law review [vol. 16:147 (13) exercises direction or control over a dentist through a written contract concerning . . . (f) final decisions relating to the employment of dental office personnel.84 ortho affiliates then pointed to seven areas of the service agreement which fell within the provisions of the statute, arguing because orthoalliance practiced medicine without a license, the contract was invalid and unenforceable, releasing the dentist from their obligations thereunder.85 first, the court looked at the contract language between the parties to sort out clinical versus non-clinical duties.86 if the dso had performed clinical duties, the dso would be in violation of indiana law. however, if the dso performed only non-clinical duties, then it would not be within the confines of the cpm law.87 the court ruled that the plain text of the contract was clear: defendant [orthalliance] has the contractual obligation to render business services and provide the business personnel necessary to discharge this duty. moreover, the contractual obligation to render these services is explicitly subject to the regulation of dental practice in indiana. so, if a certain course of conduct constitutes unlawful practice of dentistry under indiana law, the service agreement requires that defendant refrain from engaging in that proscribed conduct.88 the court explained that orthoalliance purposefully refrained itself contractually from performing duties that were contrary to indiana law, meaning performing clinical functions, and found no violation of the law.89 next, the court looked at the actions of orthalliance regarding “staff.”90 ortho affiliates claimed that orthalliance exercised control over employment decisions of “dental office personnel” in opposition of indiana law.91 if “staff” included people who actually worked on patient’s teeth, such as the dental hygienist or dental assistant, there would be a violation as defined by the idpa.92 the parties titled the paragraph “personnel and payroll,” and stated that orthalliance “shall be responsible for the performance of all payroll and payroll accounting functions.”93 further, the term “dental office personnel…refers to person employed to work on patients teeth…staff related to business personnel and thus, the company’s control over the staff pursuant to the service agreement did not 84. id. 85. id. 86. id. at 1060. 87. id. 88. id. 89. id. 90. id. 91. id. 92. id. 93. id. 2018] everyone hates going to the dentist! 161 permit the company to exercise control over employment decisions of ‘dental office personnel’ in contravention of the idpa.”94 the court ruled that payroll services are “clearly not the sort of activity within the purview of dentistry,” and it was ortho affiliates that made statements that the “orthodontists retained exclusive control over the plaintiff’s dental practice.”95 looking at the totality of the claims, the court ruled that the defendant was not practicing dentistry by providing such services.96 last, the court looked at the ability of the defendant, orthalliance, a dso, to employ dentists as employees and compared this act to the cpm doctrine of indiana.97 the plaintiff argued that by entering into an employment agreement with the defendant, a non-dentist, it “constitutes unauthorized practice of dentistry.”98 the court held “even assuming that entering into employment contracts with orthodontists construes unauthorized practice of dentistry, it was [the ortho affiliates] who agreed to engage in the unlawful act.”99 the culpable party was therefore ortho affiliates in this case, “and as a result, it ha[d] no remedy.”100 interestingly, the court pointed out that if anyone had broken the law, it was the dentist who willingly and willfully entered into the contract.101 the court did not state that when a dso employs a dentist, it violates state statute; it stated that even if it did, the culpable party would be the dentist who entered the agreement. in sum, this case ushered in an era where dsos could operate in indiana, as long as the clinical versus non-clinical line was clearly delineated in the contract and in the actions of the parties. regulation of the medical-clinical lines and not regulating normal business practices with the same heightened control shows a proper level of governmental control. this case supports the main argument of this note, that dsos perform normal business management functions of a nonclinical nature and do not need to be regulated by legislation. this case also illuminated several issues that were brought to the forefront about a decade later. 2. proposed changes to indiana cpm dental laws in january 2013,102 the issue of dsos arose once again in indiana with the proposal of new statutory language regarding who can and cannot operate a dental practice.103 in the first regular session of the 118th general assembly, language sponsored by then-senator ryan mishler that would “[p]rohibit a person 94. id at 1054. 95. id. at 1060. 96. id. 97. id. 98. id. 99. id. 100. id. 101. id. 102. s.b. 590, 118th gen. assemb., 1st reg. sess. (ind. 2013). 103. id. 162 indiana health law review [vol. 16:147 other than a licensed dentist from owning, operating, conducting, or maintaining a dental practice, office, or clinic, and makes exceptions” was read on the floor.104 the proposal included changes to indiana code pertaining to cpm doctrine for dentistry, statutory language wanted to add the language “except as provided in subsection (i), owns, operates, conducts, or maintains a dental office, or clinic, or…” to the existing language of “…is the employer of a dentist who is hired to provide dental services.”105 sections (j) and (k) were also proposed, which included language for dsos: (j)(1) to register with the dental board, (j)(2) name an active licensed dentist as dental director responsible for clinical functions, (j)(4) maintain current list of licensed dentists and make these records available to the board upon request, (k)(1) preclusion of any non-licensed entity from ownership tangible assets used in the dental office, (k)(2) employment of services personnel other than licensed dentists, and (k)(3) management in a dental office that are not related to clinical practice of medicine.106 these proposals were not initially accepted, but were then amended favorably and referred to the committee on health and provider services on february 14, 2013.107 in april of the same year, the conference committee report digest for the engrossed senate bill 590 added language to study the “delivery of dental practices by persons other than dentists” further.108 the date for the study to be completed was by december 31, 2013.109 on october 22, 2013 the health and finance commission met and heard testimony from different indiana dentistry representatives regarding the management of dsos.110 this testimony included myths and realities of dsos; dentists who praised the fact that dsos helped them manage their practices administratively; how medicaid services are expanded due to dsos, issues regarding credentialing of dentists via dso management; second opinions for work possibly over diagnosed; and the indiana attorney general’s office requesting clarification on the ambiguity of the current law that should be addressed by statute or the state dental board as regulatory authority.111 the commission ended the meeting and inserted into the final report recommended preliminary drafts of the issues presented that day.112 notably, no preliminary draft recommendations for the management of dsos in indiana were presented by the commission.113 in late november 2013, the health finance commission 104. id. 105. id. at (a)(10). 106. id. at (j)-(k)(3). 107. ind. s.b. 590. 108. common health & provider serv., conf. comm. rep. digest for esb 590, s. 118590, 1st reg. sess., at 1 (ind. 2013). 109. id. at 12. 110. health fin. comm’n, meeting minutes (oct. 22, 2013), http://www.in.gov/ legislative/interim/committee/minutes/hfcogam.pdf [https://perma.cc/jyr2-xser]. 111. id. 112. id. 113. id. 2018] everyone hates going to the dentist! 163 released their final annual report.114 although the october 22, 2013, meeting regarding dsos is recorded, the commission finalized its findings and no recommendations for action were given.115 engrossed senate bill 590 was dead; the state of indiana researched and heard the issues regarding dsos and decided against further government interference and regulations.116 this in-depth discussion of indiana’s consideration of esb 590 (dso legislation) shows that after careful consideration of the issues, the health finance commission did not choose to improve further regulations upon dsos because dsos perform nonclinical functions and do not need to be regulated by the cpm.117 3. current indiana cpm laws for dentistry and recommendations in indiana, the current cpm law allows licensed dentists to have contractual relationships with other business management entities.118 codified in indiana code § 25-14-1-23,119 a person is practicing dentistry within the meaning of this chapter if the person does any of the following: (2) directs and controls the treatment of patients within a place where dental services are performed. (10) is the employer of a dentist who is hired to provide dental services. (11) directs or controls the use of dental equipment or dental material while the equipment or material is being used to provide dental services. however, a person may lease or provide advice or assistance concerning dental equipment or dental material if the person does not restrict or interfere with the custody, control, or use of the equipment or material by the dentist. (12) directs, controls, or interferes with a dentist’s clinical judgment. (13) exercises direction or control over a dentist through a written contract concerning the following areas of dental practice: (a) the selection of a patient’s course of treatment. (b) referrals of patients, except for requiring referrals to be within a specified provider network, subject to the exceptions under ic 2713-36-5. 114. state of ind. legislative servs. agency, ann. rep. of the health fin. comm’n, gen assemb., (2013). 115. id. 116. ind. s.b. 590; see state of ind. legislative servs. agency, ann. rep. of the health fin. comm’n, gen assemb., (2013). 117. state of ind. legislative servs. agency, ann. rep. of the health fin. comm’n, gen assemb., (2013). 118. eric j. yetter, understanding corporate practice of medicine laws by state, physiciansfirst healthcare partners (aug. 25, 2017, 3:10 pm), https://www. physiciansfirsthc.com/blog/corporate-practice-of-medicine-laws-by-state/ [https://perma.cc/65gbj7m3]. 119. ind. code ann. § 25-14-1-23 (lexisnexis, 2017). 164 indiana health law review [vol. 16:147 (c) content of patient records. (d) policies and decisions relating to refunds, if the refund payment would be reportable under federal law to the national practitioner data bank, and warranties. (e) the clinical content of advertising. (f) final decisions relating to the employment of dental office personnel.120 note that all the proposed language in esb 590, previously discussed, is not present in the current indiana code. as discussed in case law, dsos who provide management services and personnel to dentists are not considered practicing dentistry.121 as mentioned, indiana is a moderately legislated state and dsos do not have to register with the dental board like texas, but there are still regulations that cross into the non-clinical aspects of dentistry like advertising and human resource management areas. this note recommends clarification of the language surrounding “dental office personnel” within section 13(f) of indiana code §25-14-1-23.122 the only language indiana currently has concerns the word “staff” from the orthoalliance case and leaves too much gray area to be interpreted.123 dsos should be able to assist the dentist by helping to recruit and manage all dental team members. dentists do not need to be statutorily excluded or purposefully included on the hiring of a dental assistant; for example, if they choose to be directly involved in personnel management, dentists can ensure that detail is added in their contracts. some dentists will not like having time they spend with their patients interrupted in order to attend to an interview or to participate in decision-making meetings as mandated by current legislation, yet some will. the law should not dictate this provision because it should be at the preference of the dentist and contractually bargained for between the parties. next, section 13(e), the “clinical content of advertising,” is also unclear.124 does this mean that a marketing team can design an ad but cannot indicate the current procedural terminology (“cpt”) code for the procedure or even mention it? admittedly, statutory language will not cover all interpretations of possible meanings, nor is it intended to; however, “clinical content” is very ambiguous and adds confusion. further, dental marketing is already covered by state administrative law,125 and service provider agreements already restrict dsos to act in accordance with the state law in which the contract is enacted. section 13(e) clinical content language should be eliminated. 120. id. 121. orthodontic affiliates p.c., 210 f. supp. 2d at 1060. 122. ind. code ann. § 25-14-1-23 (lexisnexis, 2017). 123. orthodontic affiliates p.c., 210 f. supp. 2d at 1054. 124. ind. code ann. § 25-14-1-23 (lexisnexis, 2017). 125. 828 ind. admin. code 1-1-14 (2013), invalidated by ind. prof’l licensing agency v. atcha, 49 n.e.3d 1054 (ind. ct. app. 2016) (holding 14(a) and 14(b) to be unconstitutional). 2018] everyone hates going to the dentist! 165 c. dsos can legally operate in indiana after careful review of the cpm case law in indiana and statutory language regarding practicing dentistry, all indicate that dsos can legally operate within the borders of indiana. there must be a service provider agreement between the dentist and the dso that specifically addresses the statutory language discussed to ensure that clinical and non-clinical areas are well defined. indiana should regulate and create legislation for clinical function in a dental office. indiana must fulfill the policing powers granted to it under the tenth amendment to ensure health, safety, and welfare for its citizens. however, these policing powers should not flow into areas that are customarily non-clinical business management tasks. human resource management and marketing are great examples of normal business operations that are non-clinical. over-regulation leads to vague statutory language, and vagueness hinders the efficiencies of professional business management and can reduce access to healthcare, increase costs, and lower quality. iv. dsos provide increased access, lower cost, and higher quality for patients according to state statutory language and case law, dsos are now able to operate within the border of most states. just because a dso can legally operate within the borders of a state does not mean it is an effective method for delivering healthcare. methods of delivery in healthcare are customarily assessed using the iron triangle of healthcare.126 three areas are assessed and include: access, cost and quality.127 the iron triangle states that access, cost, and quality are like a three legged stool, if you remove one of the legs the entire system becomes unstable and eventually fails.128 however, if a new healthcare initiative improves one or two (or even all three) of these legs, the healthcare initiative becomes more stable and desirable.129 using the iron triangle of healthcare assessment, this section concludes that dsos are improving the health and welfare of patients in states where dsos are operating. a. increased access to dental care rural communities, compared to urban centers, face real challenges in being able to access dental care.130 lack of access to dental care in rural areas results in 126. godfrey, supra note 4. 127. id. 128. id. 129. id. 130. rebecca singer cohen & julie stitzel, improving dental care access in rural america, the pew charitable tr. (nov. 18, 2015), http://www.pewtrusts.org/en/research-andanalysis/blogs/stateline/2015/11/18/improving-dental-care-access-in-rural-america [https://perma.cc/63v8-4ady]. 166 indiana health law review [vol. 16:147 higher rates of cavities and other serious dental issues.131 when a patient does not have access to a dentist, treatment is ignored until the pain becomes so severe that a visit to an already overburdened emergency room is sought.132 although the emergency room visit will temporarily relieve the dental condition, it does not solve the problem long-term because emergency rooms are simply not designed to take care of dental needs.133 in 2012, there were 4,438 total dental health shortage areas, areas in which there is no dentist for miles around.134 in the united states, sixty percent of dental shortage areas are located in rural communities.135 hhs predicts that over the next ten years, every state will face a rural dental shortage.136 in the crisis in rural dentistry report, both the surgeon general and the institute of medicine “call for more dentists in rural locations.”137 possible solutions to increasing access of dental care in rural communities in the crisis report include: admitting more dental students who are likely to have rural practices, providing rural experiences during dental school to attract more dentists post-graduation, and enhancing the ability of rural municipals to recruit dentists through development efforts.138another viable and positive solution is to encourage dsos within states borders.139 with dentists having record high student and practice debt, serving in a mostly rural area is simply not financially feasible.140 dsos are taking the bite out of this huge gap in access to dental care, for rural areas and urban areas too.141 dsos have financial resources and business acumen to be able to operate in smaller markets, “[a]fter all, there is strength in numbers.”142 an example of an effective dso in a rural market can be found in wisconsin, where “[o]ver the past 12 years, the marshfield clinic has opened 10 state-of-theart dental centers to serve the rural poor.”143 in indiana, dsos have dental 131. id. 132. id. 133. id. 134. id. 135. id. 136. id. 137. mark p. doescher, gina a. keppel, susan m. skillman, & roger a. rosenblatt, the crisis in rural dentistry, rural health res. ctr. pol’y brief (apr. 1, 2009), http://depts. washington.edu/uwrhrc/uploads/rural_dentists_pb_2009.pdf [https://perma.cc/tq26-byzp]. 138. id. 139. beth miller, dsos are promoting global dentistry, volunteerism, and philanthropy, group dentistry now (nov. 28, 2017), https://groupdentistrynow.com/dsos-are-promotingglobal-dentistry-volunteerism-and-philanthropy/ [https://perma.cc/q5qv-arxt]. 140. id. 141. id. 142. id. 143. alison kodjak, a good dentist is hard to find in rural america, npr (sept. 12, 2016, 6:50 am), https://www.npr.org/sections/health-shots/2016/09/12/488416888/a-good-dentist-ishard-to-find-in-rural-america [https://perma.cc/4xvl-vkpt]. 2018] everyone hates going to the dentist! 167 practices in smaller rural communities like franklin, frankfort, greenfield, greencastle, logansport, marion, and shelbyville–all underserved rural areas.144 in addition to having dental practices in smaller communities, dsos offer free dental care events, mission trips, community outreach programs, and service days.145 can a solo dentist spend time planning and administrating such events? some can, but for the majority “solo practitioners are more focused on building their practice and paying their bills, including school loans.”146 dsos charitable efforts and small community practices reach “hundreds, or even thousands, of people” all over the united states of america.147 dsos are an excellent way to increase access to dental care and therefore improve the health of citizens overall.148 if states want to solve the increasing shortage of dentists within their borders, they should welcome dsos with open arms, as dsos truly benefit citizen access. access to dental care is only one leg of the stool; how costs affect patients is another area critical to assessing dsos. b. lower costs for patients when patients visit the dentist, the thought of “how much is this going to cost me?” often runs through their minds. the centers for medicare and medicaid services (“cms”) reported healthcare spending of $3.3 trillion or $10,348 per person in 2016.149 on average dental spending consists of approximately 4% of the overall health spending in the united states.150 no wonder cost in dentistry is often overlooked by legislatures, as they consider dental care a non-essential health benefit.151 however, the ada has reported that “cost [is] the number one reason for not visiting the dentist.”152 so what do patients do when they have a dental issue that has become a health priority and there is no access to a dentist or they cannot afford it? they go to the hospital emergency room, a medical 144. supported locations, heartland dental, https://heartland.com/who-wesupport/supported-locations. 145. miller, supra note 139. 146. id. 147. id. 148. oral health in rural communities, rhihub https://www.ruralhealthinfo.org/topics/oralhealth [https://perma.cc/hm8w-q33k] (last updated feb. 15, 2017). 149. national health expenditure data, ctrs. for medicare & medicaid servs., https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andr epor t s /n a t ion a lh ea lth e xpen dd ata /n a t ion a lh ea lth accou n t sh is to r ica l . h tml [https://perma.cc/7za5-mse3] (last modified jan. 8, 2018). 150. marco vujicic, dental spending, dental economics (aug. 21, 2013), http://www. dentaleconomics.com/articles/print/volume-103/issue-8/features/dental-spending.html [https://perma.cc/47lm-295k]. 151. the oral health care system: a state-by-state analysis, am. dental ass’n, https://www.ada.org/~/media/ada/science%20and%20research/hpi/oralhealthcarestatefacts/oral-health-care-system-full-report.pdf?la=en [https://perma.cc/wy8k-gdpk]. 152. id. at 4. 168 indiana health law review [vol. 16:147 facility completely untrained and unqualified as dentists, to get temporary relief from symptoms.153 in 2015, $1.6 billion dollars was spent on emergency room visits related to dental emergencies, equating to two million patient visits.154 most of these dental emergencies could have been addressed earlier and with a better prognosis than a prescription from an emergency room.155 dsos are typically run by individuals with strong business expertise and their companies have lower cost of operations than traditional dental practices by creating operational efficiencies through innovations that lower capital costs like bulk purchases and greater negotiating power.156 a 2012 study, performed by economist arthur laffer, indicates that dsos actually charge about $225 less per patient than non-dso dentists.157 for example, in texas, a non-dso general dentist charged on average $711.54 per patient per year, or $57.41 per procedure.158 dso dentists, however, charged $483.89 per patient per year, or $47.69 per procedure, a significant reduction in actual costs to the patient.159 laffer says these cost-saving results are because “the dso model enables the provision of dental services at a lower cost to consumers of all income levels by taking advantage of economies of scale.”160 in addition to dsos costing patients less, dso practices are more efficient than a solo dental offices, and can even be profitable if they take state medicaid dental programs.161 although, also an argument for access to dental care, dsos who take medicaid are able to afford the pay-gap.162 medicaid dental programs pay less than $0.60 on the dollar, and traditional dental practices lose money without the business acumen to make this kind of a pay model profitable.163 dsos are able to leverage their operational efficiencies to close the medicaid pay-gap and keep costs lower for patients and access continuous.164 if dsos are not allowed or are heavily regulated in a state, there will be increasingly fewer patients seen by 153. cohen & stitzel, supra note 130. 154. id. 155. id. 156. wayne winegarden & donna arduin, dsos empower dentists to serve the underserved, group dentistry now (sept. 9, 2015), https://groupdentistrynow.com/dsos-empower-dentists-toserve-the-underserved/ [https://perma.cc/ws7m-9ytd]. 157. economist finds dental service organizations (dsos) more cost-effective than average independent dentists, dentistryiq (sept 25, 2012), http://www.dentistryiq.com/articles/ 2012/09 /economist-finds-dsos-more-cost-effective-than-independent-den tists .h tml [https://perma.cc/twt4-p9qf]. 158. id. 159. id. 160. id. 161. wayne winegarden, dsos illustrate how the private sector can solve public health problems, forbes (feb. 17, 2016, 2:05 pm), https://www.forbes.com/sites/econostats/2016/ 02/17/dsos-illustrate-how-the-private-sector-can-solve-public-health-problems/#6d7c062e11f5 [https://perma.cc/7ztx-azv7]. 162. id. 163. id. 164. id. 2018] everyone hates going to the dentist! 169 dentists, forcing these patients into hospital emergency rooms, which will increase the already staggering and unnecessary costs in the billions of dollars.165 in sum, taxpayers, consumers, and legislatures should embrace the innovation of the dso that helps to reduce the direct cost to patients.166 c. higher quality for patients quality is the last area of the iron triangle analysis, which will be used to survey the benefits of the dso healthcare system.167 peer review systems are used in the medical community to grant hospital privileges to applying physicians.168 peer reviews are the hospitals internal way of focusing on “quality care (e.g. education, experience, training, board certification, other appointments or affiliations, and references).”169 in indiana, the quality issue is of such significant importance that legislation has codified the duties of a peer review committee in ind. code § 34-6-2-99.170 one of the main responsibilities of a peer review committee is to evaluate the “merits of a complaint against a professional health care provider . . . based on the competence or professional conduct of an individual health care provider.”171 a healthcare professional who is found liable under a peer review committee may be reprimanded, lose his or her privileges at a facility, or lose his or her license.172 in dentistry “[s]tate dental associations conduct peer review programs to settle disputes . . . that may be addressed through peer review involve appropriateness of care, quality of care…”173 it is important to note that peer review, according to the ada, evaluates “appropriateness of care, quality of care and . . . fees.”174 quality, one of the main branches of a state dental board peer review committee, tests the treatment provided by the dentist using standards that are generally accepted with the dental community by those practitioners who regularly perform those procedures.175 oftentimes by the time an offense has reached the peer review committee, the offense is serious and usually repetitive in nature. what dsos are doing to increase quality of care is creating in-house peer-review models, called quality 165. cohen & stitzel, supra note 130. 166. economist finds dental service organizations (dsos) more cost-effective than average independent dentists, supra note 154. 167. godfrey, supra note 4. 168. huberfeld, supra note 6. 169. id. 170. ind. code ann. § 34-6-2-99 (lexisnexis 2017). 171. ind. code ann. § 34-6-2-99(a)(1)(c) (lexisnexis 2017). 172. huberfeld, supra note 6. 173. peer review resources, am. dental ass’n, http://www.ada.org/en/member-center/ member-benefits/practice-resources/peer-review-resources [https://perma.cc/tpr8-vkyk]. 174. ada guidelines for peer-review, am. dental ass’n 10 (2017), https://www.ada.org/~/ media/ada/member%20center/files/2017_ada%20peer_review_manual.pdf?la=en [https://perma.cc/mbc7-3szy]. 175. id. 170 indiana health law review [vol. 16:147 assurance programs, to increase dentist accountability and prevent possible repetitive, low quality behavior.176 this type of in-house measuring tool system monitors the dentists’ failures and success rates, patient satisfaction levels, and treatment plan completion success.177 when a dentist within an organization shows rates outside of normal parameters, the in-house dental peer committee reaches out to the dentist and helps by working with the dentist to correct the issue long before it turns into a habitual problem.178 establishing a clinical quality assurance program is a significant task not well suited for a solo dentist as they are already busy with running their own business.179 among lack of standardized measuring metrics and limited measuring systems,180 solo dentists do not have anyone to self-report to. until the patient formally complains to the state dental peer-review committee, the lack of quality of a solo dentist often goes unnoticed. in a dso, which has a quality assurance program in place, metrics will allow for anomalies to be located sooner and corrective action can be taken quicker. one of the best tools to prevent low quality care and correct dentist behavior is through training programs established by dsos. dsos love to hire experts in various dental fields to train and educate their dentists. a dso dentist will “have access to new equipment, [and] they are provided continuing education” (“c.e.”).181 in 2017, heartland dental, one of the industry’s largest dsos, recently held its annual winter conference where dentists came from all over the country to learn the latest technology, collaborate together, and build skills to better serve their patients.182 heartland boasts that its dentists have access to over 200 hours of continuing education in clinical and leadership training.183 other successful dsos, like pacific dental services, have the same continuing education focus in mind with their dentists, providing hours of free c.e. business 176. sean g. boynes, clinical quality assurance in the dental profession, dental economics (may 15, 2015), http://www.dentaleconomics.com/articles/print/volume-105/issue5 /m acroecon omics /c l in ica l-q u a li t y-assu ran ce-in -th e -den ta l -p r o f e s s ion .h tml [https://perma.cc/ug7u-38gn]. 177. id. 178. id. 179. quality measurement in dentistry: a guidebook, dental quality alliance 24 (2016), https://www.ada.org/en/~/media/ada/science%20and%20research/files/dqa_2016_quality _measurement_in_dentistry_guidebook [https://perma.cc/l4dv-6jab]. 180. id. at 12. 181. holm, supra note 15. 182. globenewswire, heartland dental holds 2017 winter conference event largest dental support organization hosts hundreds of supported dentists for two days of celebration and education, markets insider (dec. 28, 2017), http://markets.businessinsider.com/news/stocks/ heartland-dental-holds-2017-winter-conference-eventlargest-dental-support-organization-hostshundreds-of-supported-dentists-for-two-days-of-celebration-and-education-1012271330 [https://perma.cc/z437-9n4w]. 183. pat bauer, impacts of dsos on the dental industry, heartland dental 42, https://aadgp.org/wp-content/uploads/pat-aadgp-presentation-km.pdf [https://perma.cc/ftw4cphr]. 2018] everyone hates going to the dentist! 171 training, and leadership training.184 dsos know that the nexus between high quality care and long-term standardized appropriateness of care comes from training their dentists. solo dentists can access training, but the costs are higher as attending training usually requires them to temporarily close their practices and have no income. when dsos provide internal peer-review committees and highquality care through extensive training programs for dentists, patients win. v. conclusion as the salt-water taffy injured fairgoer leaves his or her new dental home, feeling great relief from the mornings tooth injury, the fairgoer is impressed with the experience. the location of the office was easy to access, the dental operatory was clean, and the dentist had the latest technology and communicated in a friendly, clear manner. the bill was thoroughly explained by the dental team and was actually less than expected for the level of trauma that occurred early in the day at the fair. the initial concern for how such a beautiful office could be run so well vanished, as the fairgoer had confidence in the clinical and business side of this new dental home. it is possible for more patients to have experiences like the fairgoer, but only if state legislatures are careful not to tread into regulation of non-clinical business management aspects of the dental world. state legislatures do not need to regulate the non-clinical business affairs of a dso. regulation of clinical dental services is within the scope of a state’s policing power. however, it is a slippery slope to enter into the regulation of nonclinical business efforts of a dso, especially when similar business activities are not statutorily regulated in other industries. indiana is a moderately statutory regulated state, but no further legislation is needed to protect the citizens’ dental health. relaxing the statutory language would help foster positive dental care for patients within indiana. when states allow dsos to operate within their borders, dsos actually improve all three areas of the iron triangle. dsos provide increased access to high quality dentists, reduction in costs, and improved dental care quality through peer-review and training. dsos are here to stay and policymakers should realize that “dental service organizations exemplify the types of health care benefits private sector firms can create—but only if the policy environment does not impede their contributions.”185 184. lifelong learning, pacific dental services, http://www.pacificdentalservices.com/ approach/lifelong-learning/ [https://perma.cc/be3d-8yuj]. 185. wayne winegarden & donna arduin, the benefits created by dental service organizations (oct. 2012), https://www.heartland.org/_template-assets/documents/ publications/pri-dsofinal.pdf [https://perma.cc/4uvy-sx5f]. microsoft word 1-volume xii masthead.docx why physicians are fiduciaries for their patients maxwell j. mehlman∗ i. introduction ..................................................................... 2 ii. who gets it wrong and why ........................................ 15 a. mistakes and confusions ............................................ 15 1. restatements and treatises ...................................... 15 2. scholarly articles and monographs ......................... 18 3. cases ......................................................................... 22 b. deliberate attacks ....................................................... 31 iii. self-interest and the bounds of physician loyalty ................................................................................. 39 a. managed care refusals to pay for medically necessary care.................................................................. 45 b. physician behavior under managed care risksharing arrangements ..................................................... 52 iv. why it is especially important for patients at this time for physicians to be fiduciaries ............................ 53 v. why reaffirming their fiduciary status is necessary for physicians ................................................. 57 vi. conclusion .................................................................... 63 * the author is distinguished university professor, arthur e. petersilge, professor of law and professor of biomedical ethics at case western reserve university. he would like to thank the faculty at loyola university chicago school of law and at the robert h. mckinney school of law at indiana university for their helpful suggestions at presentations of earlier versions of this paper; librarians andy dorchak and cheryl cheatham; and most of all, tracy li, cowan post-doctoral fellow at the case western reserve university school of law, for her tireless research assistance. note that citations generally have been omitted in quoted material. http://dx.doi.org/10.18060/18959 2 indiana health law review vol. 12:1 i. introduction that the law should regard physicians as fiduciaries for their patients would seem to be indisputable. fiduciary obligations are imposed in relationships in which one party, the fiduciary, is in a position to take advantage of the other party, called the beneficiary, principal, or “entrustor,”1 and in which the interests of the entrustors that are at stake are important to society and sometimes vital to the entrustors’ welfare.2 if the relationship were at arm’s length, entrustors would be unable to reduce the risk of being taken advantage of except by expending significant resources to monitor the superior party, and those resources would not be available to the entrustors to purchase the welfareenhancing services or property the securing of which is the reason for the relationship. in order to maximize the utility of the relationship to the entrustor by minimizing monitoring costs, the law therefore imposes on the superior party the status of a fiduciary. instead of being free to maximize their own self-interest as they would be in an arm’s-length relationship, fiduciaries are required to further the entrustors’ interests and to make restitution3 and pay punitive damages if they fail to do so.4 the relationship between patients and physicians certainly seems to fit these conditions. good health is essential to patients’ well being and is important to society. physicians are in a position to take advantage of patients 1 there is no generally accepted term for the weaker party in a fiduciary relationship. frankel coined the term “entrustor.” tamar frankel, fiduciary law, 71 calif. l. rev. 795, 800 n. 17 (1983). rodwin proposes “fiducie.” marc a. rodwin, medicine, money, & morals: physicians’ conflicts of interest 181 (1993). for a thorough exploration of the relationship between fiduciary principles and the early common law, see david j. seipp, trust and fiduciary duty in the early common law, 91 b. u. l. rev. 1011 (2011). 2 d. gordon smith calls these interests “critical resources.” d. gordon smith, the critical resource theory of fiduciary law, 55 vand. l. rev. 1399, 1402 (2002). paul miller calls them “significant practical interests.” paul b. miller, justifying fiduciary duties, 58 mcgill l. j. 1014 (2013). 3 see infra note 5, and accompanying text. 4 see infra note 59, and accompanying text. 2015 why physicians are fiduciaries for their patients 3 because they have greater knowledge and experience, and because they often have control over patients, especially when the patients are unconscious or so ill, afraid, or in pain that they cannot adequately fend for themselves. when patients do seek to protect themselves, moreover, the cost of doing so, such as by purchasing “second opinions,” is often very high, consuming resources that otherwise would be available to purchase the health care patients need. it therefore should come as no surprise that numerous courts5 and commentators6 acknowledge the fiduciary 5 see m.a. v. united states, 951 p.2d 851, 854 (alaska 1998) (“we have recognized that the unique nature of the physician-patient relationship confers upon physicians a fiduciary responsibility toward their patients.”); hales v. pittman, 576 p.2d 493, 497 (ariz. 1978) ("however, because of the fiduciary relationship between physician and patient, the scope of the disclosure required can be expanded by the patient's instructions to the physician."); hummel v. state, 196 s.w.2d 594, 595 (ark. 1946) (“there existed a most confidential relationship— that of physician and patient. herzog on medical jurisprudence, § 96 states: ‘fiduciary relationship between physician and patient. it is said that the relation of a physician to his patient is one of the highest trust and that the physician must act with the utmost good faith.’”); moore v. regents of the univ. of cal., 793 p.2d 479 (cal. 1990) (en banc) (“a physician who is seeking a patient's consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient's informed consent, disclose personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment.”); smith v. boyett, 908 p.2d 508, 513 fn. 10 (colo.1995) (“we adopt the rule that the plaintiff may establish knowing concealment by showing that the defendant either made an affirmative misrepresentation or failed to disclose material information that he had a fiduciary duty to disclose.”); gager v. mathewson, 539, 107 a. 1, 2 (conn. 1919) (“religious advisers, guardians, attorneys, and physicians . . . occupy a fiduciary relation to the testator, which requires them to use their influence in his service and not in their own.”); mcknatt v. mcknatt, 393 atl. 367, 370 (del. 1915) (“there is no fixed test to establish a fiduciary relationship. it cannot be defined. it embraces the relation of physician and patient, nurse and patient, and generally all persons who are in any relation of trust and confidence.”); emmett v. eastern dispensary and casualty hosp., 396 f.2d 931, 935 (d.c. cir. 1967) (“we find in the fiducial qualities of that relationship (between physician and patient) the physician's duty to reveal to the patient that which in his best interests it is important that he should know.”); gracey v. eaker, 837 so.2d 348, 354 (fla.2002) (“these cases are also 4 indiana health law review vol. 12:1 persuasive authority and support our conclusion that a psychotherapist who has created a fiduciary relationship with his client owes that client a duty of confidentiality, and that a breach of such duty is actionable in tort.”); cox v. athens reg'l med. ctr., inc., 631 s.e.2d 792, 798 (ga. ct. app. 2006) ("we note that, ordinarily, physicians owe a fiduciary duty to their patients with respect to the care given."); billings v. sisters of mercy, 389 p.2d 224, 228 (idaho 1964) (“it is now generally held that the fiduciary relationship between physician and patient imposes a duty of disclosure, breach of which constitutes fraudulent concealment.”) (internal citation omitted); witherell v. weimer, 85 ill.2d 146, 160, 421 n.e.2d 869, 876 (ill. 1981) (“numerous cases characterize the relationship as a fiduciary one.”); guy v. schuldt, 138 n.e.2d 891, 895 (ind. 1956) (“usually, there must be some active effort on the part of one to be guilty of concealment but where a fiduciary or confidential relationship exists, such as physician-patient, there exists a duty to disclose material information between the parties and a failure to do so results in concealment.”); baines v. blenderman, 223 n.w.2d 199, 202 (iowa 1974) ("a physician owes his patient a fiduciary duty.); natanson v. kline, 350 p.2d 1093, 1101-02 (kan. 1960) (“the courts frequently state that the relation between the physician and his patient is a fiduciary one, and therefore the physician has an obligation to make a full and frank disclosure to the patient of all pertinent facts related to his illness.”); wiseman v. alliant hospitals, inc., 37 s.w.3d 709, 713 (ky.2000) (“the fiduciary relationship between the parties grants a patient the right to rely on the physician's knowledge and skill.”); rajnowski v. st. patrick's hosp., 564 so.2d 671, 681 (la.1990) (barham and tate, jj., concurring in writ denial) (“in law the prevailing view is that the relationship between a physician and patient is a fiduciary one . . . .”) jacobs v. painter, 530 a.2d 231, 239 (me.1987) (“dr. painter's duty to disclose arose, as it always has, from the fiduciary character of the physician-patient relationship.”); sard v. hardy, 367 a.2d 525, 542 (md. app. 1977) (“i am convinced that there are fiducial qualities in the doctor-patient relationship which require the application of principles different from those governing arm's length transactions.”); alberts v. devine, 479 n.e. 2d 113, 120 (mass. 1985), cert. denied, 474 u.s. 1014 (1985) ("this court previously has recognized that the physician-patient relationship possesses fiduciary . . . as well as contractual . . . aspects."); domako v. rowe, 475 n.w.2d 30, 34 (mich. 1991) (“the physician's fiduciary duty to his patient precludes any ex parte conferences with his patient's adversary.”); madden v. rhodes, 626 so.2d 608, 617 (miss.1993) (“this court has for many, many years acknowledged the lawyer/client relationship or doctor/patient relationship as a fiduciary one.”); state ex rel. mccloud v. seier, 567 s.w.2d 127, 128 (mo. 1978) (en banc) (“moreover, as this [fiduciary] duty contemplates the physician's undivided loyalty to his patient, such duty necessarily runs contrary to the dual allegiance that would result if the physician were employed and paid by his patient's adversary.”); toman v. creighton 2015 why physicians are fiduciaries for their patients 5 memorial st. josephs hosp., inc., 217 n.w.2d 484, 489 (neb. 1974) (“‘malpractice’ has been defined by the court as the treatment of a case by a surgeon or physician in a manner contrary to the accepted rules and with injurious results to the patient; hence, any professional misconduct or any unreasonable lack of skill or fidelity in the performance of professional or fiduciary duties.”); hoopes v. hammargren, 725 p.2d 238, 242 (nev. 1986) (“this court has recognized that the physician-patient relationship is ‘fiduciary in nature.’”); stigliano v. connaught lab., inc., 658 a.2d 715, 720 (n.j. 1995) (“the relationship between treating physicians and their patients, sometimes described as fiduciary in nature, gives rise to a duty to testify in judicial proceedings about treatment rendered to the patient.”); kern ex rel. kern v. st. joseph hosp., inc., 697 p.2d 135, 139 (n.m. 1985) (“silence may sometimes constitute fraudulent concealment where a physician breaches his fiduciary duty to disclose material information concerning a patient's treatment.”); miller v. comm’r of health for state of n.y., 270 a.d.2d 584, 585, 703 n.y.s.2d 830 (3d dep't 2000) (“although petitioner was ‘only’ patient b's primary care physician, his treatment of her obviously entailed a fiduciary relationship”); black v. littlejohn, 325 s.e.2d 469, 482 (n.c. 1985) (“the relationship of patient and physician is generally considered a fiduciary one, imposing upon the physician the duty of good faith and fair dealing.”); tehven v. job serv. north dakota, 488 n.w.2d 48, 51 (n.d.1992) (“courts have generally recognized a patient's right to recover damages from a physician for unauthorized disclosure of medical information as . . . [a] breach of the fiduciary relationship between a physician and a patient.”); tracy v. merrell dow pharm., inc., 569 n.e.2d 875, 879 (ohio 1991) (“the physician-patient relationship is a fiduciary one based on trust and confidence and obligating the physician to exercise good faith.”); parris v. limes, 277 p.3d 1259, 1265 n. 3 (okla. 2012) (“oklahoma has long recognized that the relationship between a physician and patient is a fiduciary and confidential relationship”); georgetown realty v. home ins. co., 831 p.2d 7, 14 (ore. 1991) ("the form of action for a claim against a fiduciary for breaching a duty of care arising from the relationship is not materially different from a claim against a physician, a lawyer, or an engineer for breaching a duty of care arising from such a relationship."); cooper v. roberts, 286 a.2d 647, 650 (pa. super. ct. 1971) (“[a] physician's duty to disclose is . . . imposed by law which governs his conduct in the same manner as others in a similar fiduciary relationship.”); mccormick v. england, 494 s.e.2d 431, 436-37 (s.c. ct. app. 1997) (“the jurisdictions that recognize the duty of confidentiality have relied on various theories for the cause of action, including invasion of privacy, breach of implied contract, medical malpractice, and breach of a fiduciary duty or a duty of confidentiality . . . . we find the reasoning of the cases from other jurisdictions persuasive on this issue and today we join the majority and hold that an actionable tort lies for a 6 indiana health law review vol. 12:1 physician's breach of the duty to maintain the confidences of his or her patient in the absence of a compelling public interest or other justification for the disclosure.”); murfreesboro med. clinic, p.a. v. udom, 166 s.w.3d 674, 683 (tenn. 2005) ("in analyzing this issue, we see no practical difference between the practice of law and the practice of medicine . . . . these relationships are consensual, highly fiduciary and peculiarly dependent on the patient's or client's trust and confidence in the physician consulted or attorney retained.'"); nixdorf v. hicken, 612 p.2d 348, 354 (utah 1980) ("the relationship between a doctor and his patient creates a duty in the physician to disclose to his patient any material information concerning the patient's physical condition. this duty to inform stems from the fiduciary nature of the relationship . . . ."); stevenson v. johnson, 32 va. cir. 157, 159 (va. cir. ct.1993) (“it has been held that there is a fiduciary relationship between physician and patient, and that appears to be the general rule.”); lockett v. goodill, 430 p.2d 589, 591 (wash. 1967) ("the relationship of patient and physician is a fiduciary one of the highest degree.”); state ex rel. allen v. bedell, 454 s.e.2d 77, 85 (w. va. 1994) ("recently, we added a physician-patient fiduciary relationship to our jurisprudence”); steinberg v. jensen, 519 n.w.2d 753, 763, 760-61 (ct.app.1994), rev'd on other grounds, 534 n.w.2d 361 (wis. 1995) (“petrillo's public policy rationale is two-fold and is based on preserving the confidential relationship, as well as the fiduciary relationship existing between a physician and client . . . . we are similarly persuaded, and expressly adopt the rationale of petrillo.”); wardell v. mcmillan, 844 p.2d 1052, 1066-67 (wyo. 1992) ("wardell claims that a physician has a fiduciary duty not to act contrary to his patient's best interests . . . . a contrary position would needlessly pit physician against patient, potentially destroying a mutually beneficial relationship."). 6 see tamar frankel, fiduciary law 43 (2011) (“professionals have expertise that most entrustors do not possess. their services may involve entrustment of property, and in most cases—[sic] entrustment of power. thus, surgeons must be entrusted with power over the patient’s body.”); dayna bowen matthew, implementing american health care reform: the fiduciary imperative, 59 buff. l. rev. 715, 719 (2011) (“fiduciary law has defined the duties and obligations owed by individuals and institutional health care providers to patients in a wide variety of cases.”); thomas l. hafemeister and selina spinos, lean on me: a physician’s fiduciary duty to disclose an emergent medical risk to the patient, 86 wash. u. l. rev. 1167, 1187 (2009) (“because patients are so vulnerable and dependent on their physicians, the law imposes a ‘trust’ on doctors – a fiduciary responsibility stemming from the dependence and vulnerability of the patient, and from the disparity between a patient’s and a physician’s knowledge and ability to act.”); thomas l. hafemiester and richard m. gulbrandsen, jr., the fiduciary obligation of physicians to ‘just say no’ if an ‘informed’ 2015 why physicians are fiduciaries for their patients 7 nature of the patient-physician relationship. so does the american medical association (ama), whose principles of medical ethics, while not explicitly using the term “fiduciary,” states that “a physician shall, while caring for a patient, regard responsibility to the patient as paramount.”7 patient demands services that are not medically indicated, 39 seton hall l. rev. 335, 369-370 (2009) (“the physician-patient relationship embodies all three bases [vulnerability, superior knowledge and skills, and trust that physicians will promote their patient’s best interests] routinely cited as the rationale for concluding that a fiduciary duty exists between two parties.”); charity scott, doctors as advocates, lawyers as healers, 29 hamline j. pub. l. & pol’y 331, 335-342 (2007) (“this concept of the physician as fiduciary has become well accepted both in u.s. law and the ethical tenets of american professional medical associations.”); j. c. shepherd, the law of fiduciaries 29 (toronto: carswell co., 1981) (classifying physicians as an “advisor” type of fiduciary) 7 american med. ass’n, council on ethical and judicial affairs, code of ethics, principles of medical ethics (http://www.amaassn.org/ama/pub/physician-resources/medical-ethics/code-medicalethics/principles-medical-ethics.page) (last visited dec. 27, 2013). other official ama pronouncements do, however, explicitly use the term “fiduciary” to describe the patient-physician relationship. see american medical association, council on ethical and judicial affairs, ceja report 11 – a-98, “sexual or romantic relations between physicians and key third parties” (http://www.amaassn.org/resources/doc/ethics/ceja_11a98.pdf) (last visited dec. 27, 2013) (emphasis added) (“because of the impact [the decisions of key third parties such as parents] may have on the health and welfare of the patient, such individuals play an important role in the fiduciary relationship between doctor and patient, and should therefore be accorded a similar respect that is given to patients.”); barry weiss, manual for physicians 15 (2d ed. american medical association 2007) (http://www.ama-assn.org/resources/doc/amafoundation/healthlitclinicians.pdf) (last visited dec. 27, 2013) (“our legal system recognizes the patient-physician relationship as a fiduciary relationship, which is the highest standard of duty implied by law.”); american med. ass’n, report of the council on medical service, “empowering our patients: individually selected, purchased and owned health expense coverage,” cms report 9-a-98 at 16 (http://www.ama-assn.org/resources/doc/cms/a98cms9.doc) (last visited dec. 27, 2013) (emphasis added) (“all health benefit plans should be required to clearly and understandably communicate to enrollees and prospective enrollees in a standard disclosure format those services which they will and will not cover and the extent of coverage for the 8 indiana health law review vol. 12:1 the ama’s council on ethical and judicial affairs, which issues “ethics opinions” elaborating on the organization’s core ethical principles, is even clearer. “under no circumstances,” states ethics opinion e-803, “may physicians place their own financial interests above the welfare of their patients. . . . if a conflict develops between the physician’s financial interest and the physician’s responsibilities to the patient, the conflict must be resolved to the patient’s benefit.”8 former. the information disclosed should include the proportion of plan income devoted to utilization management, marketing, and other administrative costs, and the existence of any review requirements, financial arrangements or other restrictions that may limit services, referral or treatment options, or negatively affect the physician's fiduciary responsibility to his or her patients.”); american med. ass’n, report of the committee on ethical and judicial affairs, “collective action and patient advocacy,” ceja report 9-a-98 at 2 (http://www.ama-assn.org/resources/doc/ethics/ceja_9a98.pdf) (last visited dec. 27, 2013) (“physicians have a fiduciary obligation to hold their patients’ interests paramount.”). kim johnston quotes plato as stating in the republic that “no . . . physician considers his own good in what he prescribes, but the good of his patient; for the true physician is . . . not a mere moneymaker.” kim johnston, patient advocates or patient adversaries? using fiduciary law to compel disclosure of managed care financial incentives, 35 san diego l. rev. 951 (1998). 8 ama code of medical ethics, opinion 8.03, conflicts of interest: guidelines, http://www.ama-assn.org/ama/pub/physicianresources/medical-ethics/code-medical-ethics/opinion803.page? (last visited january 5, 2015). ethical principles adopted by other major physician groups are in accord. see lois snyder, the physician and the patient, 156 annals of internal 73, 75-82 (2012), available at http://annals.org/article.aspx?articleid=1033289#theethicsofpractice (“the patient–physician relationship entails special obligations for the physician to serve the patient's interest because of the specialized knowledge that physicians possess, the confidential nature of the relationship, and the imbalance of power between patient and physician. physicians publicly profess that they will use their skills for the benefit of patients, not their own benefit. physicians must uphold this declaration, as should their professional associations as communities of physicians that put patient welfare first. the physician's primary commitment must always be to the patient's welfare and best interests, whether in preventing or treating illness or helping patients to cope with illness, disability, and death. the physician must respect the dignity of all persons and respect their uniqueness. the interests of the patient should always be promoted regardless of financial http://dx.doi.org/10.7326/0003-4819-156-1-201201031-00001 2015 why physicians are fiduciaries for their patients 9 arrangements; the health care setting; or patient characteristics, such as decision-making capacity, behavior, or social status. although the physician should be fairly compensated for services rendered, a sense of duty to the patient should take precedence over concern about compensation.”); ad hoc committee on medical ethics, american college of physicians ethics manual: part 1: history of medical ethics, the physician and the patient, the physician’s relationship to other physicians, the physician and society, 101 annals internal medicine 129, 134 (1984) (“under the covenant of personal medical care the physician is ordinarily the advocate and champion of his patient, upholding the patient's interest above all others. . . .the physician must avoid any personal commercial conflict of interest that might compromise his loyalty and treatment of the patient.”); american college of surgeons, statements on principles, about acs (sept. 1 2008), http://www.facs.org/fellows_info/statements/stonprin.html (“i pledge to pursue the practice of surgery with honesty and to place the welfare and the rights of my patient above all else. . . .i will take no part in any arrangement or improper financial dealings that induce referral, treatment, or withholding of treatment for reasons other than the patient's welfare.”); american college of occupational and environmental medicine, acoem code of ethics, about acoem (last visited january 5, 2015), http://www.acoem.org/codeofconduct.aspx (“the first value or belief is that the health professional’s role is primarily to do good for the patient. this is referred to as the “principle of beneficence” in the language of bioethics. ... serving the patient’s best interest overrules personal considerations such as business needs, societal expectations, and organizational pressures. this belief dates to ancient codes of medical behavior.”); the american congress of obstetricians and gynecologists committee on ethics, commercial enterprises in america (2007), available at http://www.acog.org/resources_and_publications/committee_opinions/ committee_on_ethics/commercial_enterprises_in_medical_practice (“physicians must not engage in actions that violate or call into question their fiduciary relationship with patients.”); world medical association, duties of physicians to patients, wma international code of medical ethics (last visited january 5, 2015), http://www.wma.net/en/30publications/10policies/c8/ (“a physician shall owe his/her patients complete loyalty and all the scientific resources available to him/her.”). some other statements from the ama are more equivocal, however. see american medical association council of ethical and judicial affairs, gifts from patients to physicians, ceja report4-a-03, (2003). (“first, physicians often are viewed as holding a fiduciary duty that requires them to be dedicated to the well-being of their patients, irrespective of any advantage or gain to themselves”) (emphasis added); american medical association council of ethical and judicial affairs, managing conflicts of interest in the conduct of http://dx.doi.org/10.7326/0003-4819-101-1-129 10 indiana health law review vol. 12:1 what does come as a surprise are the sources that cast doubt on or reject outright the fiduciary nature of the patient-physician relationship. these include judicial opinions9 as well as restatements,10 legal treatises,11 clinical trials, ceja report 3-i-00 (2000) (“many aspect [sic] of the fiduciary relationship exist in the patient-physician relationship, which explains why physicians also have an ethical duty to avoid conflicts between their commitment to heal patients and their economic selfinterest”) (emphasis added). 9 dayna matthew states that only alabama has held that the patient-physician relationship is not fiduciary in nature. dayna bowen matthew, implementing american health care reform: the fiduciary imperative, 59 buff l. rev. 715, 719 n.18 (2011) (citing gunter v. huddle, 724 so. 2d 544, 546 (ala. civ. app. 1998)). the plaintiff in gunter brought an action for medical malpractice and intentional infliction of emotional distress against a physician for an alleged sexual relationship. the appellate court affirmed the lower court’s dismissal of the malpractice claim on the basis that the sexual relationship was outside the scope of the physician’s professional services. gunter, 724 so. 2d at 546. in the process, it stated that “alabama caselaw holds that a physician-patient relationship is not a fiduciary relationship as a matter of law,” id. at 546 (citing mitchell v. harris, 246 so. 2d 648, 651 (ala. 1971)). but two other jurisdictions, delaware and minnesota, also have held that the patient-physician relationship is not fiduciary in nature. mcmahon v. new castle assocs., 532 a.2d 601, 604 (del. ch. 1987) (“one may place trust in a workman of any sort and does place trust in one's physician, but it would hardly be contended that such trust would warrant chancery's assuming jurisdiction over a claim that a workman or physician caused injury by want of due care—although a claim of that very type against a trustee will be entertained in a court of equity.”); carlson v. sala architects, inc., 732 n.w.2d 324, 331 (minn.app.2007) (citing d.a.b. v. brown, 570 n.w.2d 168, 171 minn. app. 1997)) ("minnesota has declined to classify even the physicianpatient relationship as fiduciary.”). in addition, courts in 10 other states have held that, while the patient-physician may be fiduciary, patients have no cause of action against a doctor for breach of that duty, but only a cause of action for medical malpractice. hales v. pittman, 576 p.2d 493, 497 (ariz. 1978) (“additionally, if an undisclosed risk occurs, a patient may pursue a malpractice action premised on a negligence theory. we do not believe that the law in arizona should be extended to recognize a new cause of action based on breach of trust when an adequate remedy for this case already exists. to do otherwise would ignore the underlying premise that the patient controls his own destiny.”); murillo v. millner, no. d055984, 2010 wl 4730396, at *7 (cal.app. 4 dist. nov. 23, 2010) (“murillo's claims for breach of fiduciary duty and negligence are based on the same allegation, to wit: dr. 2015 why physicians are fiduciaries for their patients 11 millner failed to obtain murillo's informed consent prior to the circumcision. . . . therefore, we likewise conclude murillo failed to state sufficient facts to constitute a cause of action for breach of fiduciary duty and the trial court properly sustained the demurrer to murillo's first amended complaint.”); spoor v. serota, 852 p.2d 1292, 1294-95 (colo. app. 1992) (breach of fiduciary duty claim sought to be asserted in amended complaint was merely duplicative of negligence claim in medical malpractice action against plastic surgeon and physician who treated patient's neck ulceration that had allegedly been caused by radiation treatments.); kernke v. menninger clinic, inc., 172 f.supp.2d 1347, 1354 (d. kan. 2001) ("under kansas law, a plaintiff who brings a claim against a doctor or hospital for failure to perform the legal duty to exercise reasonable care, skill and diligence in the treatment of a patient may not also maintain other claims against the doctor or hospital for actions that arise from the same series of events as the underlying malpractice claim. . . . kansas courts will not permit a plaintiff to 'creatively classify' a claim as something other than one for medical malpractice if the substance of the claim concerns the physician-patient relationship.”); colton v. dewey, 321 n.w.2d 913, 917 (neb. 1982) (“therein we stated that any professional misconduct or any unreasonable lack of skill or fidelity in the performance of professional or fiduciary duties is ‘malpractice’ and comes within the professional or malpractice statute of limitations.”); garcia v. coffman, 946 p.2d 216, 223 (n.m. ct. app. 1997) (“it is this affirmative duty of full and fair disclosure that is at the heart of plaintiff's claim of breach of fiduciary duty. however, the failure of a physician to disclose the factors that might influence a patient in his decision is a negligence cause of action that is triable by jury.”); jones v. asheville radiological group, p.a., 518 s.e.2d 528, 532 (n.c. ct. app. 1999) (“[i]n the context of a health care provider's unauthorized disclosure of a patient's confidences, claims of medical malpractice, invasion of privacy, breach of implied contract, and breach of fiduciary duty/confidentiality should all be treated as claims for medical malpractice.”); lykins v. miami valley hosp., 811 n.e.2d 124 (ohio ct. app. 2004) (quoting ratcliffe v. univ. hospitals of cleveland, 61791, 1993 wl 69553 (ohio ct. app. mar. 11, 1993) ("lykins raised a claim for malpractice in count one of her complaint. '[t]herefore, [lykins's] claim for breach of fiduciary duty by a physician is a medical claim under r.c. 2305.11(d)(3).'"); gomez v. diaz, 57 s.w.3d 573, 581 (tex. app. 2001) (“ms. gomez contends that this amounts to a breach of fiduciary duty and unconscionable conduct. again, we hold that these are merely recast health care liability claims.”); hansen v. rogers, 119 wash. app. 1064, *7 (wash. ct. app. 2003) (“a physician owes an actionable fiduciary duty toward a patient.... the misrepresentations alleged here by hansen related directly to dr. rogers' care and treatment of hansen. the alleged 12 indiana health law review vol. 12:1 scholarly articles12 and monographs.13 even the supreme court has muddied the waters.14 misrepresentations do not support a cause of action independent from rcw 7.70.”). 10 restatement (second) of contracts restatement (second) of contracts § 161(d), cmt. f (1981) (“even where a party is not, strictly speaking, a fiduciary, he may stand in such a relation of trust and confidence to the other as to give the other the right to expect disclosure. such a relationship normally exists between members of the same family and may arise, in other situations as, for example, between physician and patient); restatement (third) of trusts § 2 cmt. (b)(1) (2003) (“thus, a confidential relation may exist although there is no fiduciary relation and is particularly likely to arise between family members or close friends or on the basis of the confidence that arises between physician and patient or priest and penitent.”). in contrast, the reporter’s notes to the restatement (third) of agency §8.2 suggest that the patient-physician relationship is fiduciary when it gives “the case of a layman who trusts a doctor” as an example of a relationship that is subject to “an inherent vulnerability” in its discussion of the agent’s fiduciary duty to the principal. restatement (third) of agency § 8.01, reporter’s notes b (2006). 11 see george gleason bogert, et al., the law of trusts and trustees § 482 (3d ed. 2009) (hereinafter “bogert on trusts”) (“on the other hand, a doctor or nurse has been held to have been in a confidential relationship with a patient. . . . ”); austin wakeman scott & william franklin fratcher, the law of trusts §2.5 (4th ed. 1987) (hereinafter “scott on trusts”) (“a fiduciary relation is to be distinguished from a merely confidential relation. . . .a confidential relation may exist although there is no fiduciary relation; it is particularly likely to exist where there is … such a relation of confidence as that which arises between physician and patient or priest and penitent.”). 12 see nan d. hunter, risk governance and deliberative democracy in health care, 97 geo. l.j. 1, 60 (2008) (“marc rodwin has argued that the concept of doctors as fiduciaries for their patients is ‘a dominant metaphor’ in health law, but that courts enforce it in only limited circumstances”); richard s. saver, in tepid defense of population health: physicians and antibiotic resistance, 34 am. j.l. & med. 431, 455 (2008) (“complicating the fiduciary duty analysis is that courts have clearly applied fiduciary duties only to limited aspects of the physician-patient relationship”); charity scott, doctors as advocates, lawyers as healers, 29 hamline j. pub. l. & pol'y 331, 399 (2008) (“although doctors perform fiduciary-like roles and hold themselves out as fiduciaries in their ethical codes, the law holds doctors accountable as fiduciaries only in restricted situations,” (citing marc. a rodwin, strains in the fiduciary metaphor: divided physician loyalties and obligations in a changing health care system, 21 am. j. l. & med. 242, 247-252 2015 why physicians are fiduciaries for their patients 13 (1995) [hereinafter “rodwin, strains”]); joseph h. king, the standard of care for residents and other medical school graduates in training, 55 am. u. l. rev. 683, 751 (2006) (“although physicians think of themselves as fiduciaries and courts sometimes label physicians as fiduciaries, … such legal fiduciary principles have been applied to physicians only in limited instances, such as obtaining patients' informed consent prior to treatment,” (citing rodwin, strains, at 241, 242-46); carl h. coleman, duties to subjects in clinical research, 58 vand. l. rev. 387, 449 (2005) (“rodwin argues that fiduciary law principles have been applied to physicians only for very limited purposes,” (citing rodwin, strains at 241)); mary crossley, infected judgment: legal responses to physician bias, 48 vill. l. rev. 195, 303 (2003) (quoting rodwin, strains at 247-248); d. gordon smith, the critical resource theory of fiduciary duty, 55 vand. l. rev. 1399, 1462-63 (2002) (quoting rodwin, strains at 247-248); e. haavi morreim, another erisa twist: the mysterious case of pegram and the missing fiduciary, 63 u. pitt. l. rev. 235, 239 (2002) (“it is debated whether physicians are fiduciaries in the most technical legal sense,” (citing rodwin, strains, at 247)); michelle oberman, mothers and doctors’ orders: unmasking the doctor’s fiduciary role in maternal-fetal conflicts, 94 nw. u. l. rev. 451, 456 (2000) (“in reality, however, although the fiduciary model accurately describes the doctor-patient relationship, doctors have eschewed the legal regulations that are associated with fiduciary relationships.”); id. at 457 (referring to “the limited version of fiduciary duty applicable to doctors.”); id. at 458-459 (“as professor rodwin concludes in his thorough study of the field, fiduciary law principles have been applied to physicians in only a narrow set of circumstances”); ken marcus gatter, the continued existence and benefit of medicine's autonomous law in today's health care system, 24 u. dayton l. rev. 215, 282 (1999) (“the fiduciary responsibility physicians have for patients has always been limited compared to other fiduciary relationships,” (citing rodwin, strains, at 242-51)); gregory d. jones, primum non nocere: the expanding "honest services" mail fraud statute and the physician-patient fiduciary relationship, 51 vand. l. rev. 139, 182 (1998) (although courts label physicians as fiduciaries, “fiduciary law principles have been applied to physicians for very few purposes,” (citing rodwin, strains at 247)); marc. a rodwin, strains at 242 (“the thesis is that although doctors perform fiduciary-like roles and hold themselves out as fiduciaries in their ethical codes, the law holds doctors accountable as fiduciaries only in restricted circumstances. moreover, private and public groups often expect doctors to work for parties other than patients, and health policy now focuses on the population rather than individual patients.”); id. at 247-248. (“in medicine there is a gap between the fiduciary ideal and practice. physicians often call themselves fiduciaries and courts sometimes label physicians as 14 indiana health law review vol. 12:1 fiduciaries, especially in informed consent cases. still, fiduciary law principles have been applied to physicians only for very limited purposes. these include requiring that physicians not abandon patients, keep information they learn confidential, obtain patients' informed consent to treatment, and in one case, disclose to patients any financial interest in clinical research. aside from these limited circumstances, physicians—as clinicians—are not held to fiduciary standards, especially with respect to financial conflicts of interest. courts and legislatures have not developed comprehensive fiduciary obligations for physicians and do not consistently hold them accountable as such. one health law scholar has even asked whether fiduciary principles should constrain physician behavior.”); e. haavi morreim, blessed be the tie that binds? antitrust perils of physician investment and self-referral, 14 j. legal med. 359, 375-376 (1993) (“not all scholars agree that the relationship is strictly fiduciary. some consider it only a confidential relationship. still, a number of the courts not explicitly dubbing the relationship fiduciary have nevertheless noted that this relationship does have the ‘fiducial qualities’ of trust and confidence, and that physicians have duties that clearly exceeded those of arms-length transactions. in either case, we can at the least agree that the relationship gives rise to certain obligations of fidelity.”); e. haavi morreim, conflicts of interest: profits and problems in physician referrals, 262 jama 390, 390–94 (1989) (not all courts and commentators regard physicians as fiduciaries “in the full legal sense of the term”). 13 rodwin, supra note 1. at one point, he states that “fiduciary law for doctors is now all but nonexistent. id., at 236. elsewhere in the book he states that the fiduciary role of physicians is “very limited.” see id., at 210 (although physicians sometimes call themselves fiduciaries, fiduciary law has been applied to physicians only for very limited purposes. these include requiring that physicians not abandon patients, keep information they learn confidential, and obtain patients’ informed consent to treatment. nevertheless, the roles played by physicians resemble those of professionals considered fiduciaries. they advise patients and act on their behalf. the medical ethos of acting in patients’ interests embodies the fiduciary ideal. the patient-physicians relationship, though unique, poses the same accountability problem as fiduciary relations.”); id., at 184 (“physicians often act as traditional fiduciaries and espouse a fiduciary ethic. in a few situations, courts apply fiduciary law principles to doctors. but aside from these limited circumstances, physicians—as clinicians—are not held to fiduciary standards, especially with respect to financial conflicts of interest. …when behavior is questionable, courts require fiduciaries to prove that they have not violated their trust. such is not the case for physicians. for example, unlike typical fiduciaries, who cannot accept gifts that may influence their professional decisions, doctors frequently accept gifts from pharmaceutical firms and medical suppliers.”). http://dx.doi.org/10.1080/01947649309510922 http://dx.doi.org/10.1001/jama.1989.03430030078038 2015 why physicians are fiduciaries for their patients 15 this article begins by explaining why courts and commentators minimize or reject the fiduciary nature of the patient-physician relationship: a combination of errors; confusions about the difference between common law and equitable remedies; and misguided policy objectives. the article then proposes how physicians should discharge their fiduciary obligations to patients in specific cases. the article concludes by spelling out why reaffirming the fiduciary nature of their relationship is essential for physicians as well as for patients. ii. who gets it wrong and why a. mistakes and confusions errors and misunderstandings about fiduciary doctrine lead some sources to reject or undercut the fiduciary nature of the patient-physician relationship. 1. restatements and treatises the restatement (third) of trusts describes the patientphysician relationship as “confidential” but not fiduciary, while the restatement (second) of contracts agrees that it is not “strictly speaking” fiduciary and instead calls it a relationship of “trust and confidence.”15 while the restatement of trusts gives no support for its position, the reporter’s notes to the restatement of contracts cites to a 1978 article by fleming james jr. and oscar s. gray.16 not only do the authors of that article say no such thing at the given citation, but elsewhere in the article they state that the patient-physician relationship is fiduciary.17 14 see pegram v. herdrich, 530 u.s. 211 (2000), discussed infra notes 43-48 and accompanying text. 15 see supra note 10. 16 restatement (second) of contracts § 161(d) cmt. f , reporter’s notes (1981), (citing fleming james jr. and oscar s. gray, misrepresentation—part ii, 37 md. l. rev. 488, 524-525 (1978)). 17 id. at 541 (“misrepresentation may similarly toll a statute of limitations and, for this purpose, where there is a fiduciary relationship, 16 indiana health law review vol. 12:1 both bogert on trusts and scott on trusts also describe the relationship as “confidential” rather than fiduciary.18 like the authors of the restatement (third) of trusts, scott gives no support for his position.19 bogert does cite six court opinions for the proposition,20 but acknowledges that “there is no uniform practice among courts in their use of the phrases ‘fiduciary relation’ and ‘confidential relation,’ and that the terms are often used as synonyms.”21 bogert cites cases from three of the same six jurisdictions in support of this proposition.22 yet other decisions in all six of these jurisdictions have recognized the patient-physician relationship as “fiduciary.”23 such as that of physician to patient, ‘fraudulent concealment’ sometimes shades into nondisclosure of relevant facts ‘known to the doctor or readily available to him through efficient diagnosis.’”) (emphasis added). 18 see supra note 11. 19 see supra note 11. 20 faulkner v. beatty, 327 p.2d 41 (2d dist. app. cal. 1958); hendrix v. schrecengost, 358 s.e.2d 486 (ga. app. 1987); estate of mcrae, 522 so. 2d 731 (miss. 1988); ostertag v. donovan, 331 p.2d 355 (n.m. 1958); hewitt v. bullard, 128 n.e. 2d 411 (n.c. 1962); hodge v. shea, 168 s.e. 2d 82 (s.c. 1969), cited at bogert on trusts, supra note 11 at 306-307. 21 bogert on trusts, supra note 11 at 278-279. shepherd at one point similarly states that “we come across the term ‘confidential relationship,’ which may mean a type of fiduciary relationship, or alternatively, a class of general relationships, some of which are fiduciary in nature.” shepherd, supra note 6, at 7. later, however, he asserts that “confidential relationships must be a category of fiduciary relationships. id. at 162. 22 id. at n.1. 23 moore v. regents of the univ. of cal., 793 p.2d 479 (cal. 1990) (en banc) (“a physician who is seeking a patient's consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient's informed consent, disclose personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment.”); cox v. athens reg'l med. ctr., inc., 631 s.e.2d 792, 79 n.14 (ga. ct. app. 2006) ("we note that, ordinarily, physicians owe a fiduciary duty to their patients with respect to the care given."); madden v. rhodes, 626 so.2d 608, 618 (miss.1993) (“this court has for many, many years acknowledged the lawyer/client relationship or doctor/patient relationship as a fiduciary one.”); kern ex rel. kern v. st. joseph hosp., inc., 697 p.2d 135, 139 (n.m. 1985) (“silence may sometimes constitute fraudulent concealment where a physician breaches his fiduciary duty to disclose material information concerning 2015 why physicians are fiduciaries for their patients 17 the reasons for denominating the patient-physician relationship as “confidential” or one of “trust and confidence” rather than as fiduciary are unclear.24 however, many sources recognize that the former differs from the latter in the burden of proof placed on plaintiffs. as shepherd states: [a] transaction in which a fiduciary self-deals will, almost without exception, be voidable at the option of the beneficiary. …once the beneficiary determines to avoid the transaction, it is only in the very rare case that the fiduciary will be able to meet the very heavy onus on him to demonstrate that there was no abuse of power.”25 on the other hand, as scott on trusts observes: [i]f one person is in a confidential, but not a fiduciary, relation to another, a transaction between them will not be set aside at the instance of one of them unless he in fact reposed confidence in the other, and the other, by fraud or undue influence or otherwise, a patient's treatment.”); black v. littlejohn, 325 s.e.2d 469, 482 (n.c. 1985) (“the relationship of patient and physician is generally considered a fiduciary one, imposing upon the physician the duty of good faith and fair dealing.”); mccormick v. england, 494 s.e.2d 431, 436-37 (s.c. ct. app. 1997) (“the jurisdictions that recognize the duty of confidentiality have relied on various theories for the cause of action, including invasion of privacy, breach of implied contract, medical malpractice, and breach of a fiduciary duty or a duty of confidentiality. ...we find the reasoning of the cases from other jurisdictions persuasive on this issue and today we join the majority and hold that an actionable tort lies for a physician's breach of the duty to maintain the confidences of his or her patient in the absence of a compelling public interest or other justification for the disclosure.”). 24 they may relate to the fact that the patient-physician relationship was not actually called “fiduciary” until the mid-19th century, while english courts had earlier recognized certain relationships as “confidential.” 25 shepherd, supra note 6, at 159. 18 indiana health law review vol. 12:1 abused the confidence placed in him. . . . the burden of showing an abuse of a confidential relation is on the person seeking to set aside the transaction.26 in short, designating the patient-physician relationship as merely one of confidence significantly weakens the legal protections for patients, and is unjustified in view of the absence of a good reason for doing so. 2. scholarly articles and monographs in an influential 1993 book, professor mark rodwin stated that “fiduciary law for doctors is all but nonexistent,”27 and that “physicians--as clinicians--are not held to any fiduciary standards, especially with respect to 26 scott on trusts, supra note 11, at §2.5. see e. haavi morreim, medicine meets resource limits: restructuring the legal standard of care, 59 u. pitt. l. rev. 1, 72, 71 n.245 (1997) (citing scholarship, cases, and treatises in support of this contention); demers v. gerety, 515 p.2d 645, 655 (n.m. ct. app. 1973) (sutin , j., concurring) (“in a fiduciary relationship, the burden is on the defendant to show scrupulous good faith in obtaining an express written authority to operate or to extend the operation when it conflicts with the unequivocal beliefs of the patient.”). see also the following cases, cited in johnston, supra note 7, at 951, n.65: knaebel v. heiner, 663 p.2d 551, 553 (alaska 1983); smith v. tele-commc’n, inc., 184 cal. rptr. 571, 575 (cal. ct. app. 1982); konover dev. corp. v. zeller, 635 a.2d 798, 810 (conn. 1994); labovitz v. dolan, 545 n.e.2d 304, 311 (ill. app. ct. 1989); sampson v. hunt, 665 p.2d 743, 754 (kan. 1983); gaynier v. ginsberg, 715 s.w.2d 749, 754 (tex. app. 1986); wilkins v. lasater, 733 p.2d 221, 228 (wash. ct. app. 1987). an illustration of the difference between a relation of confidence and a fiduciary relationship is illustrated in the debate in employment law over which status more aptly describes the relationship of employee to employer. see michael sharp, a normbased analysis of employment obligations of confidence and trust, 18 n. zeal. bus. l. q. 341, 346 (2012) (discussing univ. of nottingham v. fishel [2000] icr 1462 (qb) “confidence and trust principles only require a party to take the other party's interests into account rather than have regard to them completely”; v. sims, is employment a fiduciary relationship? univ. of nottingham v. fishel [2000] irlr 471; [2000] icr 1462 (qb), 30 industrial l. j. 101-110 (2001). 27 rodwin, supra note 1, at 236. http://dx.doi.org/10.1093/ilj/30.1.101 2015 why physicians are fiduciaries for their patients 19 financial conflicts of interest.”28 the first assertion had no supporting references, while the reference he gave for the second was, in his words, “an exception” that did not support his point.29 elsewhere in the book rodwin was slightly more nuanced, asserting that “although physicians sometimes call themselves fiduciaries, fiduciary law has been applied to physicians only for very limited purposes.”30 the footnote accompanying this statement also gives no references, but merely says that “one health law scholar has even asked whether fiduciary principles should constrain physicians’ behavior,”31 citing a 1983 book chapter by boston university law professor fran miller. miller, however, says no such thing. on the contrary, she states that: [i]t is generally recognized that the parties to a physician-patient relationship are frequently on unequal footing. . . . the law redresses this kind of imbalance in certain relationships by requiring people who occupy positions of trust, such as physicians, to subordinate self-interest 28 id. at 210. 29 id. at 210 and n.140 (citing moore v. regents of the univ. of cal., 792 p.2d 479 (cal. 1990)). 30 id. at 184. later in the book, he states: “physicians often act as traditional fiduciaries and espouse a fiduciary ethic. in a few situations, courts apply fiduciary law principles to doctors. but aside from these limited circumstances, physicians—as clinicians—are not held to fiduciary standards, especially with respect to financial conflicts of interest. . . . when behavior is questionable, courts require fiduciaries to prove that they have not violated their trust. such is not the case for physicians. for example, unlike typical fiduciaries, who cannot accept gifts that may influence their professional decisions, doctors frequently accept gifts from pharmaceutical firms and medical suppliers.” id. at 210. again, none of the references he cites supports his claims. 31 id. at 356, n. 37, citing frances h. miller, secondary income from recommended treatment: should fiduciary principles constrain physician behavior?, in the new health care for profit: doctors and hospitals in a competitive environment 153, 153–69 (bradford h. gray ed., 1983) (emphasis in rodwin). 20 indiana health law review vol. 12:1 to the well being of their charges. such a relationship is called a fiduciary relationship.32 unfortunately, rodwin’s unsupported claim that the fiduciary role of physicians was limited was accepted uncritically by many health law scholars.33 one reason that rodwin believes that the law regards physicians as fiduciaries at most in a limited sense is that physicians have conflicts of interest with their patients.34 32 id. at 356, n. 37 (citing frances h. miller, secondary income from recommended treatment: should fiduciary principles constrain physician behavior?, in the new health care for profit: doctors and hospitals in a competitive environment 153, 153–69 (bradford h. gray ed., 1983)) (emphasis in rodwin). 33 see supra note 12. 34 see rodwin, strains, supra note 12, at 252-253. rodwin describes the following conflicts: obligations to more than one patient, such as when engaging in triage, considering the needs of other patients in deciding whether to place a patient in intensive care, treating both a dying patient and a patient in need of a transplant organ from that patient, and considering the interests of the fetus when caring for a pregnant woman ; an obligation to protect persons who are not their patients, such as physicians’ duty to institutionalize dangerous patients and warn identified third parties of a risk of harm from a patient and their duty to breach patient confidentiality to alert public health officials to a patient’s contagious disease; owing loyalty to certain organizations as well as to patients, such as sports teams, the military, hospital management, and employers; rationing medical resources on behalf of “providers, insurers, government, or society at large”; and “financial conflicts of interest.” id. at 248. these financial conflicts include accepting gifts from pharmaceutical firms and medical suppliers. id., at 250. rodwin ultimately says that the law should hold physicians to a more expansive fiduciary duty to patients, but that this is a task for legislatures rather than courts; he acknowledges that having conflicts does not preclude physicians from being fiduciaries for patients: “there is ample precedent for balancing competing interests within a fiduciary framework [and] . . . [m]any fiduciaries . . . have to balance the interests of competing individuals or groups. corporate officers must serve the interest of different groups of stockholders . . . . lawyers are expected to be zealous advocates for their clients while serve as officers of the court and protect the integrity of the judicial system.” id. at 255-56. “therefore, the fact that physicians have obligations to third parties does not mean that they cannot be fiduciaries for patients.” id. at 256. 2015 why physicians are fiduciaries for their patients 21 but while fiduciary duties may preclude some conflicts,35 they do not necessarily rule out all; as shepherd observes, “the mainstream of the law of fiduciaries does not punish a fiduciary for having a conflict of interest, but finds him liable only if he actually chooses interests other than those of his beneficiaries.”36 even in the most paradigmatic fiduciary relationship, that between trustees and trust beneficiaries, trustees often face the conflicting interests of different beneficiaries or conflicts between a grantor’s life interest in income-production and a remainderman’s interest in growth assets. this is no less true in the patient-physician relationship than in other fiduciary relationships. haavi morreim, a scholar who has written some of the most thoughtful legal scholarship about the fiduciary aspects of the patient-physician relationship, observes, for example, that physicians “have long faced conflicts of interest, as fee-for-service reimbursement rewarded excessive care.”37 indeed, if the stronger party in a service relationship did not have conflicts of interest with the weaker party, there would be no reason for the law to make the stronger party a fiduciary to begin with.38 35 see julian velasco, fiduciary duties and fiduciary outs, 21 geo. mason l. rev. 157, 162 (2013) (“fiduciaries must avoid conflicts of interest that might tempt them to act against the interests of the beneficiary”); see, e.g., restatement (third) of agency, §§ 801-.05 (2006). 36 j. c. shepherd, the law of fiduciaries 41 (1981), accord kim johnston, patient advocates or patient adversaries? using fiduciary law to compel disclosure of managed care financial incentives, 35 san diego l. rev. 951, 961 (1998) (“it is sometimes said that a fiduciary may not even enter a situation where a conflict of interest could arise. however, it is probably more accurate to say that, when faced with a conflict between duty and self-interest, the fiduciary must act according to the duty.”) 37 e. haavi morreim, cost containment challenging fidelity and justice, hastings cent. rep., dec. 1988, at 20-25. 38 however, morreim argues that physicians who enroll their patients in clinical trials in which the physicians are investigators are no longer fiduciaries for the patients. see e. haavi morreim, the clinical investigator as fiduciary: discarding a misguided idea, 33 j. l., med. & ethics 586 (2005). one reason she gives is that investigators owe their primary loyalty to the research protocol and the future http://dx.doi.org/10.1111/j.1748-720x.2005.tb00521.x 22 indiana health law review vol. 12:1 3. cases courts in three states, alabama, delaware, and minnesota, have declared that the patient-physician relationship is not fiduciary in nature.39 the alabama cases do not give a reason. delaware, unique among united states jurisdictions in retaining the distinction between courts of common law and courts of equity, is concerned that recognizing the relationship as fiduciary and allowing patients to bring actions in equity for breaches of physicians’ fiduciary duty would reduce the ability of its court of chancery to carry out its primary function of resolving corporate disputes.40 minnesota is concerned that patients who may benefit from the results of the investigation, rather than to the subjects. id. at 599. morreim also points out that investigators expose subjects in clinical trials to risks that would be unacceptable in the relationship between physicians and patients, such as the risk of receiving a placebo rather than a potentially beneficial experimental intervention and the risk of harm from experimental procedures. id. at 590. however, fiduciary doctrine does not preclude fiduciaries, including physicians, from subordinating patient welfare to the welfare of third parties in certain carefully circumscribed circumstances. moreover, physicians routinely expose patients to risks from unproven interventions when they prescribe drugs or medical devices “off-label,” that is, in a manner that is not approved by the food and drug administration, and this does not necessarily violate their fiduciary duty to the patients. curiously, morreim does not discuss the core aspect of a physician’s fiduciary duty, namely, the prohibition against sacrificing patient welfare for doctors’ own self-interest. as applied to physician-investigators, the prohibition might seem to preclude physicians from obtaining financial or reputational benefits from enrolling patients as subjects, both of which are standard practice. see, e.g., ctr. for health & pharm. law & policy, seton hall univ. sch. of law, a white paper on conflicts of interest in clinical trial recruitment & enrollment: a call for increased oversight 1 (2009), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1515762 (last visited january 5, 2015). 39 see supra note 9. 40 see mcmahon v. new castle assocs., 532 a.2d 601, 604 (del. ch.1987) (“among the most ancient of headings under which chancery's jurisdiction falls is that of fiduciary relationships . . . . chancery takes jurisdiction over ‘fiduciary’ relationships because equity, not law, is the source of the right asserted. thus, when this court, for example, said ‘a fiduciary relationship is a situation where one person reposes special 2015 why physicians are fiduciaries for their patients 23 patients could assert a cause of action for breach of fiduciary duty to avoid the statute of limitations for medical malpractice and the need to prove actual injury.41 similarly, the united states supreme court and courts in ten other states, while acknowledging or at least not rejecting the fiduciary nature of the relationship, have held that a patient has no cause of action for breach of a physician’s fiduciary duties that is distinct from an action for medical malpractice.42 the supreme court case, trust in and reliance on the judgment of another or where a special duty exists on the part of one person to protect the interests of another,’ [citation omitted], attention must be paid to the word ‘special’ lest the statement be thought to describe too broadly chancery's concerns with relationships where an element of trust, as commonly understood, is present. one may place trust in a workman of any sort and does place trust in one's physician, but it would hardly be contended that such trust would warrant chancery's assuming jurisdiction over a claim that a workman or physician caused injury by want of due care—although a claim of that very type against a trustee will be entertained in a court of equity.”); delaware court of chancery (http://courts.delaware.gov/chancery/ ) (last visited feb. 13, 2014) (“the delaware court of chancery is widely recognized as the nation's preeminent forum for the determination of disputes involving the internal affairs of the thousands upon thousands of delaware corporations and other business entities through which a vast amount of the world's commercial affairs is conducted.”). 41 see d.a.b. v. brown, 570 n.w. 2d 168, 171 (minn. ct. app. 1997). (“we decline to create a new cause of action [for breach of doctors’ fiduciary duty to patients] simply to permit the putative class to avoid showing injury or to circumvent the legislatively mandated statute of limitations.”); e. haavi morreim, high-deductible health plans: new twists on old challenges from tort and contract, 59 vand. l. rev. 1207, 1242 (2006) (discussing courts’ concern about the need for patients to prove actual damages). 42 see hales v. pittman, 576 p.2d 493, 497 (ariz. 1978) (“additionally, if an undisclosed risk occurs, a patient may pursue a malpractice action premised on a negligence theory. we do not believe that the law in arizona should be extended to recognize a new cause of action based on breach of trust when an adequate remedy for this case already exists. to do otherwise would ignore the underlying premise that the patient controls his own destiny.”); murillo v. millner, no. d055984, 2010 wl 4730396, at *7 (cal. app. 4 dist. nov. 23, 2010) (“murillo's claims for breach of fiduciary duty and negligence are based on the same allegation, to wit: dr. millner failed to obtain murillo's informed consent prior to the circumcision . . . . therefore, we likewise 24 indiana health law review vol. 12:1 pegram v. herdrich, involved an employer-sponsored health plan called “carle,” which was a qualified employee health benefit plan under the employee retirement income conclude murillo failed to state sufficient facts to constitute a cause of action for breach of fiduciary duty.”); spoor v. serota, 852 p.2d 1292, 1294-95 (colo.app.1992) (“breach of fiduciary duty claim sought to be asserted in amended complaint was merely duplicative of negligence claim in medical malpractice action against plastic surgeon and physician who treated patient's neck ulceration that had allegedly been caused by radiation treatments.”); kernke v. menninger clinic, inc., 172 f.supp.2d 1347, 1354 (d. kan. 2001) ("under kansas law, a plaintiff who brings a claim against a doctor or hospital for failure to perform the legal duty to exercise reasonable care, skill and diligence in the treatment of a patient may not also maintain other claims against the doctor or hospital for actions that arise from the same series of events as the underlying malpractice claim . . . . kansas courts will not permit a plaintiff to 'creatively classify' a claim as something other than one for medical malpractice if the substance of the claim concerns the physician-patient relationship.”); colton v. dewey, 321 n.w.2d 913, 917 (neb. 1982) (“therein we stated that any professional misconduct or any unreasonable lack of skill or fidelity in the performance of professional or fiduciary duties is ‘malpractice’ and comes within the professional or malpractice statute of limitations.”) (internal citation omitted.); garcia v. coffman, 946 p.2d 216, 223 (n.m. ct. app. 1997) (“it is this affirmative duty of full and fair disclosure that is at the heart of plaintiff's claim of breach of fiduciary duty. however, the failure of a physician to disclose the factors that might influence a patient in his decision is a negligence cause of action that is triable by jury.”); jones v. asheville radiological group, p.a., 518 s.e.2d 528, 532 (n.c. ct. app. 1999) (“in the context of a health care provider's unauthorized disclosure of a patient's confidences, claims of medical malpractice, invasion of privacy, breach of implied contract, and breach of fiduciary duty/confidentiality should all be treated as claims for medical malpractice”); lykins v. miami valley hosp., 811 n.e.2d 124, 141 (2d dist. montgomery county 2004) ("lykins raised a claim for malpractice in count one of her complaint. '[t]herefore, [lykins's] claim for breach of fiduciary duty by a physician is a medical claim under r.c. 2305.11(d)(3).'"); gomez v. diaz, 57 s.w.3d 573, 581 (tex. app.-corpus christi 2001, no pet.) (“ms. gomez contends that this amounts to a breach of fiduciary duty and unconscionable conduct. again, we hold that these are merely recast health care liability claims.”); hansen v. rogers, no. 50259-0-i, 2003 wl 23019948, at *7 (wash. app. ct. dec. 29, 2003) (“a physician owes an actionable fiduciary duty toward a patient . . . . the misrepresentations alleged here by hansen related directly to dr. rogers' care and treatment of hansen. the alleged misrepresentations do not support a cause of action independent from rcw 7.70.”). 2015 why physicians are fiduciaries for their patients 25 security act (erisa).43 carle was owned by physicians who received a bonus at the end of the year if the plan was profitable—in other words, if they collectively spent less on enrollee health care than they collected in premiums and payments. one way to help the bottom line of the plan was to provide medical care only at those hospitals and other facilities that were affiliated with the plan. dr. pegram, one of carle’s owners, examined herdrich, who was complaining of pain in her groin, and found nothing wrong. according to the complaint, “[s]ix days later, dr. pegram discovered a six by eight centimeter inflamed mass in herdrich’s abdomen. despite the noticeable inflammation, dr. pegram did not order an ultrasound diagnostic procedure at a local hospital, but decided that herdrich would have to wait eight more days for an ultrasound, to be performed at a facility staffed by carle more than 50 miles away. before the eight days were over, herdrich’s appendix ruptured, causing peritonitis.”44 herdrich sued dr. pegram alleging that the doctor not only had committed medical malpractice, but also had breached his fiduciary duty to her under erisa, since the bonus feature created an incentive “to make decisions in the physicians’ self-interest, rather than the exclusive interests of plan participants.”45 in a unanimous decision, the court rejected herdrich’s claim on the basis that her allegations did not show that the defendant physicians had been acting as fiduciaries under erisa.46 furthermore, the justices went on to explain in 43 pegram v. herdrich, 530 u.s. 211 (2000). 44 id. at 215. 45 id. at 216. 46 the court’s reasoning, that the physicians were making “mixed eligibility and treatment decisions” and, as such, were not acting as fiduciaries under erisa, 530 u.s. at 229-232, is confused. the court is describing doctors’ decisions about whether a treatment approach was both medically necessary and covered under the erisa health plan. (the court misuses the term “eligibility,” which technically refers to whether the patient was entitled to any benefits from a health plan, to describe a coverage decision, which concerns the specific services that a patient is entitled to.) since the treatment in question, an ultrasound to detect appendicitis, clearly was covered under the plan if it was 26 indiana health law review vol. 12:1 dicta that, if the physicians who owned the plan had been acting as fiduciaries, herdrich still would not be entitled to the relief that she sought: the defense of any hmo would be that its physician did not act out of financial interest but for good medical reasons, the plausibility of which would require reference to standards of reasonable and customary medical practice in like circumstances. that, of course, is the traditional standard of the common law. . . . thus, for all practical purposes, every claim of fiduciary breach by an hmo physician . . . would boil down to a malpractice claim, and the fiduciary standard would be nothing but the malpractice standard traditionally applied in actions against physicians.47 in other words, the court seemed to be saying, physicians acting in their own self-interest at a patient’s expense could be sued only for malpractice and not for a breach of fiduciary duty. since the pegram case involved the fiduciary duties of health benefit plan trustees under erisa,48 the foregoing dicta might not be deemed to extend to the equitable duties generally owed by physicians to their patients. however, a number of other courts have echoed the court’s reasoning in rejecting breach of fiduciary claims in non-erisa cases as duplicating malpractice claims. the same year as pegram, for example, the supreme court of illinois decided neade v. portes,49 in which the plaintiff alleged that her spouse, who had been complaining of chest pain, had died from a heart medically necessary, the only decision the doctors were making was whether or not the ultrasound was medically necessary, which is what the court calls a “treatment” decision, and there was no “mix” about it. see id. at 229-232. 47 id. at 235. 48 erisa states, for example, “a fiduciary with respect to a plan shall not deal with the assets of the plan in his own interest or for his own account.” 29 u.s. code § 1106 (b)(1). 49 739 n.e.2d 496 (ill. 2000). 2015 why physicians are fiduciaries for their patients 27 attack because his physician had refused to order an angiogram. the physician belonged to a group practice that contracted with a health maintenance organization (hmo) to provide care to plan enrollees. the physicians were “globally-capitated,” in that they received a lump sum of $75,000 a year to cover the costs of all referrals and tests by non-plan providers; if costs for these services exceeded that amount, the group would have to pay for them out of its own revenues, but if the costs were less, the group would pocket the difference. the plaintiff alleged that the doctor should have disclosed this financial arrangement, which would have prompted her and her husband to seek a second opinion about the need for an angiogram, and that his failure to make this disclosure was a breach of his fiduciary duty as well as malpractice.50 the court held that, although physicians were fiduciaries for their patients, “illinois courts have never recognized a cause of action for breach of fiduciary duty against a physician”51 and that in any event, citing pegram, “plaintiff's breach of fiduciary duty claim is a re-presentment of her medical negligence claim.”52 courts in ten other states have taken the same approach and refused to recognize breach of fiduciary claims against physicians as distinct from medical malpractice claims.53 of course, a claim that a physician breached a fiduciary duty is not the same as a claim that the physician committed medical malpractice. the former deals with whether or not the physician acted loyally, while the latter deals with whether the physician acted with due care.54 50 id. at 499. 51 id. at 500. 52 id. at 501-502. 53 see cases cited supra in note 42. 54 see shepherd, supra note 6, at 49 (“[t]he duty of care has absolutely no necessary connection with fiduciary relationships. in the instances in which fiduciary relationships have a duty of care attached, we posit that that duty of care rests either in contract (e.g. most agents) or in tort (e.g. some types of advisers).”). there is some overlap between a physician’s fiduciary duty and the duty to provide reasonable care. one aspect of reasonable care, for example, is to continue to care for a patient until care is no longer needed or further care would be futile, known as the “continuous treatment rule,” or until the patient or the 28 indiana health law review vol. 12:1 furthermore, as noted earlier,55 in an action for breach of fiduciary duty, once a plaintiff establishes that a fiduciary had a conflict of interest with the entrustor, the burden shifts to the fiduciary to prove that he or she nevertheless acted loyally;56 in a malpractice action, on the other hand, the plaintiff bears the burden of proving that the defendant failed to meet the applicable standard of care. in addition, the remedies are different. a successful plaintiff in a malpractice action is entitled to the common law remedy of restoration, namely, money damages designed to place the plaintiff as much as possible in the position in which the plaintiff would have been had there been no malpractice. the successful plaintiff in an action physician properly terminates the relationship. a physician can terminate the relationship unilaterally by giving the patient notice and a reasonable opportunity to obtain care elsewhere. improperly terminating the relationship is a type of medical malpractice called abandonment. see payton v. weaver, 131 cal. app. 3d 38, 182 cal. rptr. 225 (1st dist. 1982). in that case, a physician wanted to terminate a relationship with a dialysis patient who was noncompliant and whose bad behavior disrupted treatment for other patients. if the physician had not given the patient adequate notice and an opportunity to find treatment from another dialysis center, the physician would have been liable for abandonment; if another reason for improperly terminating the relationship was the physician’s own self-interest, the physician also would be liable for a breach of fiduciary duty. 55 see shepherd, supra notes 6 and 36 and accompanying text. 56 see e. haavi morreim, the clinical investigator as fiduciary: discarding a misguided idea, 33 j.l. med & ethics 586, 589 (2005) (“ [i]f the entrustor can prove that his fiduciary is in a conflict of interest, the law will presume that the fiduciary abused his power or exploited the entrustor, and thereby will place on the fiduciary the burden of proving he did not.”). see also johnston, supra note 7, at 962-963 (“in light of fiduciary law's protective function, many courts have also created special rules to help plaintiffs in these cases. these special rules recognize the fact that the ‘law watches with the greatest jealousy transactions and dealings between persons occupying a fiduciary relationship.’ for example, courts often reverse the normal rule that the plaintiff has the burden of proof in a civil case and hold that, once the plaintiff has shown that a fiduciary relationship exists, the defendant has the burden of disproving its breach. many courts also hold that the existence of a fiduciary relationship gives rise to a presumption of fraud or undue influence that can only be rebutted by clear and convincing evidence.”). http://dx.doi.org/10.1111/j.1748-720x.2005.tb00521.x 2015 why physicians are fiduciaries for their patients 29 for breach of fiduciary duty, on the other hand, is entitled to an accounting for profits or a constructive trust, designed to place the plaintiff in the position the plaintiff would have been in if the fiduciary had acted loyally.57 in addition, a successful plaintiff may obtain specific performance58 and punitive damages.59 in pegram, for example, the plaintiff asked the court to order the defendants to refund to the plan any profits that they made by acting in their own selfinterest rather than in the interests of their patients, in other words, the remedy of an accounting for profits or constructive trust.60 such a remedy would not be available in a malpractice action; instead, the plaintiff in pegram only would have been entitled to compensation for the losses she sustained as a result of rupturing her appendix.61 57 see frankel, supra note 6, at 249-251 (describing accounting for profits and constructive trusts). see also shepherd, supra note 6, at 116 (“[t]he constructive trust is one of the major remedies in the law of fiduciaries.”). 58 see frankel, supra note 6, at 249-251 (discussing the availability of injunctive relief). 59 see id. at 258--260 (discussing the availability of punitive damages). punitive damages are usually not available for mere medical malpractice. see theodore eisenberg et. al., juries, judges, and punitive damages: an empirical study, 87 cornell l. rev. 743, 745 (2002) (“misperceptions about juries and punitive damages are especially strong. contrary to popular belief, juries rarely award such damages, and award them especially rarely in products liability and medical malpractice cases.”). 60 pegram, 530 u.s. at 233. 61 indeed, one reason the court in neade v. portes gave for rejecting the plaintiff’s fiduciary cause of action was that her lawyers had not asked for any remedy specifically for breach of fiduciary duty: “plaintiff requests $50,000 in addition to costs of the lawsuit in damages under count i [for negligence]. count ii of plaintiff's amended complaint attempts to state a cause of action for dr. portes' breach of fiduciary duty. the damages alleged in count ii are identical to those alleged in count i. here, though attempting to couch the claim in different terms, plaintiff is essentially pleading the same cause of action which caused the same damages.” 739 n.e.2d 496, at 503 (ill. 2000). the patient’s lawyers in moore vs. regents of the university of california, 793 p.2d 479 (cal. 1990), similarly did not correctly appreciate the remedy for a breach of fiduciary duty, and instead brought an action for conversion against physicians who allegedly failed to inform the plaintiff that they intended to transform cancer cells that they were going to remove from http://dx.doi.org/10.2139/ssrn.248419 30 indiana health law review vol. 12:1 finally, although patients alleging breaches of fiduciary duty are likely to have a stronger case if they can show that the physician’s disloyalty was accompanied by malpractice, physicians technically can breach their fiduciary duty even if the care that they provided meets the standard of care for negligence. for example, the physician may have made a mistake that was reasonable but that could have been avoided had the physician not acted out of self-interest.62 alternatively, the physician may have deprived the patient of care that, while reasonable, would have been of even higher quality had the physician not acted selfinterestedly.63 his spleen into a lucrative cell line for use by researchers. in an action for conversion, the plaintiff is entitled to be restored to his property, namely, the handful of cancer cells removed from his spleen, while in an action for breach of fiduciary duty, the plaintiff would have been entitled to the enormous monetary value of the cell line. 62 in lauro v. travelers ins. co., a patient who underwent an unnecessary radical mastectomy brought a malpractice action against the pathologist who misdiagnosed a benign tumor as cancerous. 261 so.2d 261 (la. ct. app. 1972). the majority of the court held that the mistake, although it might have been avoided had the pathologist used state-of-the-art equipment, was nevertheless reasonable. id. at 266. the patient did not allege that the pathologist had used older equipment out of economic self-interest (in fact, the equipment was owned by the hospital where the surgery was performed), but if the patient could show that that in fact was the reason, the plaintiff might have a cause of action against the pathologist for breach of fiduciary duty even though use of the older equipment was still acceptable according to the standard of care at the time. 63 in a 2001 pennsylvania supreme court case, duttry v. patterson, 771 a.2d 1255 (pa. 2001), the plaintiff needed a surgical procedure to remove part of her esophagus and stomach and alleged that the surgeon botched the operation. the plaintiff also alleged that, prior to the operation, she had asked the surgeon how often he had performed the procedure, to which he replied that he did it once a month, but she found out later that he had only done it nine times in the past five years. the plaintiff sued the physician for failing to obtain her informed consent, which in pennsylvania is a battery action. id. at 1258. after dismissing the plaintiff’s cause of action on the ground that pennsylvania law does not require physicians to disclose their experience when they obtain a patient’s informed consent, the court noted that “other causes of action provide avenues for redress to the injured patient. for example, it is conceivable that a physician's lack of experience in performing an operation would support a plaintiff's case in 2015 why physicians are fiduciaries for their patients 31 b. deliberate attacks the previous section described how sources that have rejected the fiduciary nature of the patient-physician relationship have misunderstood fiduciary doctrine. far more troubling, however, are the sources that deliberately subvert the fiduciary nature of the relationship because they believe that physicians should not be loyal to their patients. according to these commentators, it is necessary for doctors covertly to withhold care for their patients in order to reduce health care costs. morreim, for example, states that “it is time to dispose of the naive notion that physicians can offer patients untainted loyalty, unlimited altruism, and boundless professional self-effacement” adding: physicians retain some control over resources because only they are licensed to prescribe medical interventions. therefore, third parties who want to limit their expenditures must either control physicians' decisions (and thereby abridge their clinical autonomy), or influence physicians by placing them under powerful incentives. … loyalty remains an important value in this fiduciary relationship, negligence.” id. at 1259. but in inquiring about the surgeon’s experience, the plaintiff might have been trying not only to avoid being operated on by a surgeon who was incompetent, but to have the surgery performed by the best surgeon in the area. similarly, in moore vs. regents of the university of california, 792 p.2d 479 ( cal. 1990), the california supreme court characterized the duty to obtain a patient’s informed consent as in part fiduciary because the physicians’ failure to obtain informed consent was their failure to disclose “personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment.” 792 p. 2d at 485. by subordinating the plaintiff’s well being to the physicians’ personal interests, the physicians breached their fiduciary duty to the patient as well as their duty of care. 32 indiana health law review vol. 12:1 but it can no longer be a simplistic mandate always to serve the patient above oneself.64 the “third parties” to which morreim is referring are government health programs such as medicare and medicaid and private health plans. in order to control spending, these organizations have adopted various forms of “managed care” aimed at physician decision-making. these include the capitation arrangement for the physicians in the pegram case, a requirement that physicians obtain prior authorization from the plan before it will pay for what they order,65 and financial rewards for physicians who limit hospital admissions and other expensive services for their patients. similarly, when justice souter, writing for the unanimous court in pegram, suggested in dicta that patients could sue physicians only for malpractice and not for acting disloyally, he did so out of concern that allowing patients to sue for disloyal behavior effectively would outlaw efforts by managed care to limit health care spending: [t]he judiciary has no warrant to precipitate the upheaval that would follow a refusal to dismiss herdrich's erisa claim. the fact is that for over 27 years the congress of the united states has promoted the formation of hmo practices. … if congress wishes to restrict its approval of hmo practice to certain preferred forms, it may choose to do so. but the federal judiciary would be acting contrary to the congressional policy of allowing hmo organizations if it were to entertain an erisa fiduciary claim portending wholesale attacks on existing hmos solely because of their 64 e. haavi morreim, redefining quality by reassigning responsibility, 20 am. j. l. & med. 79, 92 (1994). 65 see murray v. unmc physicians, 806 n.w.2d 118 (neb. 2011), discussed infra notes 111-115 and accompanying text. 2015 why physicians are fiduciaries for their patients 33 structure, untethered to claims of concrete harm.66 another highly respected health law scholar, mark hall, is also concerned that allowing patients to sue doctors for violating their fiduciary duty to patients would interfere with efforts to control health care costs. hall wants patients to trust their physicians, acknowledging that trust aids the healing process.67 but he does not want patients to be able to hold doctors legally accountable for breaching that trust, arguing that this would undermine trust by substituting trust in the law for what david mechanic calls “interpersonal trust” in the physicians’ personal integrity. in a commentary accompanying hall’s article, law professor greg bloche claims that hall’s real motive is to enable physicians to withhold costly services from trusting patients who do not suspect that this is happening, and, if they find out, to give them no legal recourse.68 66 pegram, 530 u.s. at 233-234. the last sentence is perplexing since the plaintiff alleged that the physicians’ disloyalty caused her concrete harm in the form of a ruptured appendix and peritonitis. moreover, as hafemiester & bryan observe, “many states do not have either a causation requirement or an actual harm requirement associated with their fiduciary causes of action. this is in part because . . . the breach of loyalty is the harm . . . .”, thomas l. hafemiester & sarah p. bryan, beware those bearing gifts: physicians’ fiduciary duty to avoid pharmaceutical marketing, 57 u. kan. l. rev. 491, 524 (2009). 67 see mark a. hall, law, medicine, and trust, 55 stan. l. rev. 463, 479 (2002) (“the effectiveness of care depends on patients’ confidence in its efficacy”). 68 m. gregg bloche, trust and betrayal in the medical marketplace, 55 stan. l. rev. 919, 949 (2002) (hall “wants physicians to do the heavy lifting of cost control by drawing upon the trust they have accrued through the profession’s commitment to fidelity to patients”). hall professed astonishment at bloche’s accusation, but acknowledged that patients merely need to be informed about managed care incentives for withholding care when they enroll in the plan. mark hall, ideology and trust: a reply to bloche, 55 stan. l. rev. 955, 966-967 (2002) (“the only respect in which i favor hidden rationing is the following: if patients are properly informed when they join and renew with an insurance plan, and perhaps also when they select a physician group, i would not require physicians to remind patients about financial http://dx.doi.org/10.2307/1229596 http://dx.doi.org/10.2307/1229676 http://dx.doi.org/10.2307/1229677 34 indiana health law review vol. 12:1 the practice that hall, the court in pegram, and morreim are advocating is called “bedside rationing.” it is a response to the need to control health care spending based on the recognition that much of the increase in spending is attributable to physician behavior; as the saying goes, the most expensive piece of medical equipment is the physician’s pen.69 the objective of bedside rationing is for doctors, acting in response to economic incentives created by their patients’ health plans, to decline to provide patients with expensive interventions, thereby saving scarce health care resources for other members of the plan and for society in general.70 considerations or resource-based constraints each time the physician makes a treatment decision. i don’t disagree with physicians who want to practice medicine this way, but i argue that failing to adhere to such an ethic should not be the basis for tort liability. instead, i think it is sufficient for legal purposes that physicians be candid about financial considerations when duly informed patients ask questions or express concern about the financial dimension of medical decision making. in short, it should be up to each patient whether to trust or whether to verify.”). the illinois supreme court in neade similarly held that a patient only has the right to receive information about a physician’s conflicts of interest from the plan, and then only if the patient makes a written request. 739 n.e.2d at 503-504. 69 much of the blame has been placed on “fee-for-service” payment systems (“ffs”) that reward physicians economically the more care that they give to their patients. historically, third party payers could withhold payment for services that they considered to be medically unnecessary, but they did so only after the patient had received the service; managed care, on the other hand, has sought to resolve the necessity question before the patient receives the care, so that a refusal to cover the service typically deprives the patient of the health benefit that the physician is seeking to provide. 70 see e. haavi morreim, benefits decisions in erisa plans: diminishing deference to fiduciaries and an emerging problem for provider-sponsored organizations, 65 tenn. l. rev. 511, 524 (1998) (distinguishing between conflicts of interest, involving “a conflict between a fiduciary's duties to beneficiaries and his own personal welfare,” and conflicts of obligation, which “pit the fiduciary's duties to an individual beneficiary against his duties to various other parties,”); id. at 527-528 ( “the fiduciary for a health plan cannot literally have ‘undivided loyalty,’ because his loyalty is necessarily divided among the many beneficiaries whose conflicting needs command his attention. the fiduciary can at most be ‘disinterested’ and ‘impartial,’ in the sense that he looks out for beneficiaries' interests rather than his own, and does 2015 why physicians are fiduciaries for their patients 35 bedside rationing is problematic, however. ideally, the interventions that the doctor withheld would provide only marginal health benefits to the patient, and the doctor deems the benefits to be outweighed by the cost. but as suggested by neade, where the patient allegedly died for lack of a timely diagnostic test, the foregone health benefits may be significant, in that case spelling the difference between life and death. another critical aspect of bedside rationing, as mentioned, is that the patients do not realize that it is taking place. the point is to reduce the social cost of rationing by avoiding contentious public decision-making, such as by the “death panels” excoriated by republicans during the debate over the affordable care act.71 but as the cases seeking to hold the physician liable for breach of fiduciary duty demonstrate, the patients or their families may discover the ruse, in which case they and the physician bear the social costs, and unlike rationing by public rulemaking, the patient now is an expensive “identifiable” rather than a less-expensive “statistical” life.72 moreover, people who are aware of the practice of bedside rationing by word of mouth or from press and internet accounts will try to protect themselves against it by attempting to research not exploit their dependence to promote his personal advantage.”). but see e. haavi morreim, the clinical investigator as fiduciary: discarding a misguided idea, 33 j. l., med. & ethics 586, 589 (2005) (“the fiduciary also must not compromise the entrustor's welfare for the benefit of third parties. as noted by finn, the fiduciary's duty in the ‘service of his beneficiaries' interests’ includes ‘a duty not to act for his own benefit, or for the benefit of any third person.’ of course sometimes it may be impossible to avoid such conflicts of obligation. nevertheless, the fiduciary's presumption is that the entrustor's interests are generally to take priority over third parties' interests as well as the fiduciary's personal benefit.”) (quoting p. d. finn, fiduciary obligations 3 (1977) 71 see bernard w. corn, ending end-of-life phobia—a prescription for enlightened health care reform, 361 n. eng. j. med. e63 (2009) (“the term—introduced on sarah palin's facebook page and subsequently ranked as a finalist on many word-of-the-year lists—has come to connote a theoretical body that determines which patients deserve to live when health care is rationed.”). 72 see lisa heinzerling, the rights of statistical people, 24 harv. envtl. l. rev. 189-207 (2000). http://dx.doi.org/10.1111/j.1748-720x.2005.tb00521.x http://dx.doi.org/10.1056/nejmp0909740 36 indiana health law review vol. 12:1 the medical options themselves, questioning doctors’ recommendations, and seeking second opinions, all of which entail monitoring and other transactions costs that fiduciary relationships are created to minimize. finally, studies of bedside rationing show that physicians are prone to discriminate against poor and minority patients.73 so physicians should not sacrifice the welfare of their patients in order to conserve economic resources for others,74 and doing so should be regarded as a breach of 73 see elizabeth n. chapman et. al., physicians and implicit bias: how doctors may unwittingly perpetuate health care disparities, 28 j. gen. int. med. 1504 (2013) (describing research showing how implicit biases affect clinical decision-making). 74 the ama appeared to endorse the notion that physicians have a duty to conserve scarce health resources for the benefit of patients and society in general. see ama council of ethical and judicial affairs, physician stewardship of health care resources report 1-a-12, 1 (2012) (http://www.ama-assn.org/resources/doc/ethics/ceja-1a12.pdf) (last visited january 22, 2014) (describing report as providing “ethical guidance to support physicians in making fair, prudent, cost-conscious decisions for care that meets the needs of individual patients and to help ensure availability of health care for others.”) (emphasis added). the report went on to state that “physicians’ primary ethical obligation is to promote the well-being of individual patients. physicians also have a long-recognized obligation to patients in general to promote public health and access to care. this obligation requires physicians to be prudent stewards of the shared societal resources with which they are entrusted. managing health care resources responsibly for the benefit of all patients is compatible with physicians’ primary obligation to serve the interests of individual patients.” id. at 5. the report also stated: “arguments that physicians should never allow considerations other than the welfare of the patient before them to influence their professional recommendations and treatment do not mesh with the reality of clinical practice. physicians regularly work with a variety of limits on care: clinical practice guidelines, patient preferences, availability of certain services, the benefits covered by a patient’s insurance plan, and the time physicians and nurses can spend caring for a patient all influence what interventions physicians recommend and what care they provide.” id. at 2. similarly, another ceja report in 2013 stated that “not to be lost in the quest for innovative payment models is the fundamental expectation that physicians have a fiduciary and ethical obligation to their patient and society to use precious health care resources efficiently.” ama, physician payment reform: early innovators share what they have learned at 5 (july 2012) (http://www.ama-assn.org/resources/doc/washington/physician-paymenthttp://dx.doi.org/10.1007/s11606-013-2441-1 2015 why physicians are fiduciaries for their patients 37 their fiduciary duty. decisions to withhold potentially beneficial interventions for reasons of cost should be made instead through an open and public process, the same way these decisions are made in the british national health system.75 precedent for this approach in the united states exists in the form of the system for allocating transplant organs, which is not left to individual physicians or hospitals but governed by a set of rules established by a reform-white-paper.pdf) (last visited dec. 27, 2013). these statements are misleading, however. the first report went on to explain that “the focus of the report is on physicians’ recommendations and decisions in everyday situations that are often overlooked, in which physicians’ choice of one among several reasonable alternatives can affect the availability of resources across the community of patients or the aggregate cost of care in the community. . . . everyday choices are also distinct from “high stakes” decisions about interventions that can mean life or death for patients or forestall extremely poor outcomes, such as decisions to initiate mechanical ventilation in emergent circumstances when the patient’s prognosis is uncertain. arguably, in situations when there is significant risk of harm, cost considerations, if they play a role at all, are better addressed through collectively designed policy than left to individual decisions physicians must grapple with at the bedside.” ceja report 1-a-12, supra, at 1. moreover, in terms of withholding care from patient to preserve resources for others, the report merely advises physicians to “choose the course of action that requires fewer resources when alternative courses of action offer similar likelihood and degree of anticipated benefit compared to anticipated harm for the individual patient, but require different levels of resources . . . .” id. at 7. in other words, physicians should not waste resources, but only in the sense that they should provide patients with the cheaper of two equally beneficial alternatives, which is not bedside rationing. 75 see lestyn williams, institutions, cost-effectiveness analysis and healthcare rationing: the example of healthcare coverage in the english national health service, 41 policy & politics 223 (2013). oregon in the early 1990s attempted to employ a quasi-public rationing process to decide what services should be provided to medicaid patients. the effort ran into numerous roadblocks, but also differs fundamentally from what is being advocated here, in that the oregon decision-makers and public participants were asked what they thought should be covered for others, namely, persons on medicaid, rather than what they thought everyone, including themselves, should be entitled to receive. for an analysis of the oregon program, see maxwell j. mehlman, the oregon medicaid program: is it just?, 1 health matrix 175 (1991). http://dx.doi.org/10.1332/030557312x655477 38 indiana health law review vol. 12:1 national body, the united network for organ sharing.76 these rules exist not in order to save money but because of the shortage of organs. the incompatibility of the physician’s fiduciary duty with bedside rationing, however, does not mean physicians must never place the interests of others above those of their patients. the law recognizes three well-established situations in which this is permissible. one is triage, when there are not enough resources physically available to provide treatment to everyone in immediate need, and where physicians are allowed to bypass certain patients in order to give priority to patients who can be treated most efficiently with what is at hand.77 a second well-recognized exception to the duty of loyalty is when a physician is required to breach patient confidentiality in order to warn an identifiable victim whom the patient is placing in immediate, serious peril.78 the third exception is to protect the public health, when physicians are authorized to act in ways that may be contrary to the interests of the patient, such as breaching confidentiality by reporting them to public health officials, who in turn may order the patient to be quarantined or forcibly treated.79 76 note that the approach to allocating transplant organs, unlike the oregon medicaid approach described in the preceding footnote, determines the allocation rules for everyone, not just patients on medicaid. 77 david g. c. mccann, preparing for the worst: a disaster medicine primer for health care, 30 j. legal med. 329, 342 (2009) (describing triage). 78 see w. jonathan cardi, a pluralistic analysis of the therapist/physician duty to warn third parties, 44 wake forest l. rev. 877 (2009) (discussing physicians’ duty to warn third parties). 79 see physician stewardship of health care resources, ama council of ethical and judicial affairs, 2 (2012) http://www.amaassn.org/resources/doc/ethics/ceja-1a12.pdf (last visited january 22, 2014) (“historically, medicine as a learned profession has been understood to have a social responsibility to use knowledge and skills to enhance the common good, including obligations to protect public health and safety, even if this might require restricting the liberties of individual patients (opinion e-2.25, ‘the use of quarantine and isolation as public health measures’; opinion e-2.24, ‘impaired drivers and their physicians’).”); see lawrence o. gostin, public health http://dx.doi.org/10.1080/01947640903143581 2015 why physicians are fiduciaries for their patients 39 while the physician’s fiduciary duty precludes the physician from subordinating the interests of the patient to the interests of third parties, except in the limited circumstances just discussed, the crux of physicians’ fiduciary duty is to avoid acting in their own self-interest at the patient’s expense. how far must physicians go in sacrificing their own welfare in order to fulfill their fiduciary duty to their patients? iii. self-interest and the bounds of physician loyalty scholars of fiduciary relationships cite justice cardozo’s statement that the degree of loyalty that fiduciaries owe is “not honesty alone, but the punctilio of an honor the most sensitive,”80 and claim that “with respect to the fiduciary relationship, a fiduciary may not act counter to the interests of the beneficiary”81 and that “fiduciaries are not allowed to promote the interests of third parties or themselves.”82 these statements suggest that physicians would violate their fiduciary duty to patients anytime they acted in their own self-interest. but this is misleading, since fiduciaries are entitled to reasonable compensation for their efforts on behalf of entrustors, even though the compensation comes at the entrustors’ expense, as in the form of a charge on the assets of a trust. similarly, a physician clearly is entitled to be paid a reasonable fee by the patient or on the patient’s behalf.83 this makes sense, of course, even in the context of a fiduciary relationship; although patients might prefer if physician’s services were free, patients would not be better off if this were the case because there would be few if any law: power, duty, restraint, 371-460 (2d ed., 2008) (discussing public health interventions). 80 meinhard v. salmon, 164 n.e. 545, 546 (n.y. 1928). 81 velasco, supra note 35, at 162. 82 rodwin, supra note 1, at 183. 83 the ama code of ethics thus only prohibits fees that are “illegal or excessive.” ethics opinion e-605-fees for medical services, ama code of ethics, (1994 update) (http://www.amaassn.org/ama/pub/physician-resources/medical-ethics/code-medicalethics/opinion605.page?) (last visited oct. 13, 2014). 40 indiana health law review vol. 12:1 patient-physician relationships to begin with. as morreim observes: [p]rofessional altruism is the physician’s promise to seek the benefit of the patient and refrain from exploiting his vulnerability to enhance the physician’s own interests. it is a presumption to hold the patient’s interests paramount, but with the caveat that this presumption is sometimes defeasible by powerful overriding considerations. it is selfdenial, even if not self-sacrifice or high devotion.”84 moreover, a physician is only obliged to care for a patient at a reasonable time and in a reasonable place; while an earlier age saw doctors expected to make house calls, even in the middle of the night, this is no longer required and is one of the reasons that some patients pay extra for 24/7 access to doctors in so-called concierge practices.85 at the other extreme, some sources argue that physicians ought to be able to place their own interests ahead of patients’ so long as patients are made aware that 84 e. haavi morreim, cost containment challenging fidelity and justice, 18 hastings ctr. rep., 20, 25 (dec. 1988). shepherd similarly states that “in some cases the rigidity of the fiduciary concept must be tempered by a social policy against restraint of trade.” shepherd, supra note 6, at 136. 85 see james stathopoulos, concierge medicine: quality care for a price, 19 annals health l. 155 (2010) (discussing concierge practices). a disturbing possibility is that a similar sort of concierge practice will emerge in which better-off patients will pay extra to ensure that their physicians will act as fiduciaries for them. see also m. gregg bloche & peter d. jacobson, the supreme court and bedside rationing, 284 jama 2776, 2779 (2000) (“unless congress or the states limit rewards to physicians for withholding care, we may witness not a wholesale abandonment of [fidelity to individual patients], but the socioeconomic stratification of access to professionals who sustain their commitment to it. wealthy americans who insist on their physicians’ loyalty at the bedside will be able to afford health plans that do not undermine it. other consumers may be limited by their buying power to physicians with a conflict of interest.”). http://dx.doi.org/10.1001/jama.284.21.2776 2015 why physicians are fiduciaries for their patients 41 this might happen.86 these sources take a page from the fiduciary relationship between corporate directors and shareholders, in which directors are permitted to self-deal so long as they disclose their intention and receive permission from the rest of the board.87 in fact, most proponents of disclosure as a remedy for physicians acting in their own self-interest do not even propose to give patients that much protection, since they do not want physicians to have to alert patients to an imminent breach of fiduciary duty in the course of providing care.88 instead, 86 in relation to fiduciary doctrine generally, shepherd states, for example, that “if the fiduciary provides effective disclosure, he may reduce his influence over the other party enough to prevent the presumption of undue influence from arising.” shepherd, supra note 6, at 204. 87 see victor brudney, contract and fiduciary duty in corporate law, 38 b.c. l. rev. 595, 665 (1997) (“evolving corporate fiduciary obligations appear to be narrowing the disclosure requirements imposed on directors seeking stockholder consent to depart from the prohibition against self-dealing, but developing conceptions of adhesion, unconscionability or good faith appear to be expanding disclosure requirements for contracting parties seeking comparable consent.”). 88 see johnston, supra note 7, at 986 (“another problem with disclosure is its potential to weaken the doctor-patient relationship.”). but johnston in the end opts for physician disclosure: “even if hmo disclosure were required, there is still a need for physician disclosure.” id. at 988. johnston cites as a benefit of physician disclosure that it would “encouraging patients to challenge their doctors” (id. at 989) and “would also encourage patients to take a more proactive approach to their health. for example, knowledge of financial incentives might make patients question or challenge their doctors' recommendations or insist on getting more information about their diagnosis.” id. at 988. in short, johnston supports “consumer-driven” health care, which expects patients to limit health care spending by making prudent health care choices. she states, for example, that “disclosure would help patients become more meaningfully involved in the debate over managed care by making them more aware of how much health care costs.” id. at 990. morreim also seems to think that physician disclosure is sufficient in some cases to discharge the physician’s fiduciary duty. see e. haavi morreim, the clinical investigator as fiduciary: discarding a misguided idea, 33 j. l., med. & ethics 586, 589 (2005) (“the fiduciary must not exploit the entrustor to promote his own gain. he must not enter into avoidable conflicts of interest that would pit his own welfare against the entrustor's or, when unavoidable, he must disclose such http://dx.doi.org/10.1111/j.1748-720x.2005.tb00521.x 42 indiana health law review vol. 12:1 they only want patients to be warned of the possibility that their physicians may act disloyally when the patient enrolls in a health plan. mark hall, for example, states that “if patients are properly informed when they join and renew with an insurance plan, and perhaps also when they select a physician group, i would not require physicians to remind patients about financial considerations or resource-based constraints each time the physician makes a treatment decision.”89 by the same token, in neade vs. portes, discussed earlier,90 the supreme court of illinois noted that the illinois “legislature has chosen to put the burden of disclosing any financial incentive plans on the hmo, rather than on the physician.”91 conflicts and permit the entrustor to decide whether and how he may handle this transaction, or indeed, continue as fiduciary.”); e. haavi morreim, blessed be the tie that binds? antitrust perils of physician investment and self-referral, 14 j. legal med. 359, 376 (1993) (“a fiduciary … must try to avoid conflicts of interest, but when they cannot be avoided, the fiduciary must make full disclosure and invite the beneficiary to decide what should be done.”). 89 mark hall, ideology and trust: a reply to bloche, 55 stan. l. rev. 955, 966-967 (2002). 90 see the discussion supra notes 50 and 71 and accompany text. 91 739 n.e.2d at 504. ironically, the plaintiff in neade had merely wanted her husband’s physician to disclose that he had a conflict of interest in not recommending a life-saving angiogram. id. at 499. one reason that the court gave for not requiring disclosure by the physician was the burden that this would impose on physicians “to remain cognizant at all times of every patient's particular hmo and that hmo's policies and procedures.” id. at 504 (citing m. hall, a theory of economic informed consent, 31 ga. l. rev. 511, 525-26 (1997) (“[a] typical primary care physician in a metropolitan city may have a dozen or more contracts with managed care networks, while specialists may have several dozen or even a hundred. it is not feasible to ask physicians to keep track of the payment incentives and treatment rules for each of these many different plans, nor is this necessarily good public policy”).). the dissent in neade effectively dismissed this concern: “doctors share generously in the bounty provided by modern medicine, and there is no reason to believe that they cannot manage or afford the administrative tools necessary to keep them fully apprised of the payment incentives affecting a particular patient's care. indeed, there is every reason to believe that payment incentives are one aspect of health care plans that physicians such as dr. portes will have no trouble at all keeping track of. according to the allegations in plaintiff's complaint, which must be taken as true, dr. portes was well aware that the http://dx.doi.org/10.1080/01947649309510922 http://dx.doi.org/10.2307/1229677 2015 why physicians are fiduciaries for their patients 43 disclosure of conflicted behavior may be sufficient for corporate directors in view of the knowledge and sophistication of the other members of the board and the shareholders whom they represent. furthermore, disclosure by physicians before they take a specific action, as opposed to by a health plan at the beginning of the patient’s enrollment, is better than giving patients no fiduciary protection at all since they can avoid having to monitor their physician’s behavior until they receive the warning. but physician disclosure is not adequate. it still requires patients to expend resources that could be devoted instead to the purchase of health care if the patient could trust physician’s to forego taking advantage of the patient’s weaker position. moreover, patients generally can be expected to be far less sophisticated than corporate directors or shareholders and therefore may have more difficulty anticipating the consequences of a physician’s selfinterested behavior, leading the patients to overor underprotect themselves. but the main objection to relying on disclosure to enable patients to protect themselves is simply referral recommended by his associates and needed by plaintiff's husband would reduce the profit he would receive from the health plan. that is exactly why he refused to make the referral, and it is why plaintiff's husband is now dead.” id. at 508 (harrison, c.j., dissenting). see also shea v. esensten, 107 f.3d 625, 629 (8th cir. 1997), cert. denied, 522 u.s. 914 (1997) (“when an hmo's financial incentives discourage a treating doctor from providing essential health care referrals for conditions covered under the plan benefit structure, the incentives must be disclosed and the failure to do so is a breach of erisa's fiduciary duties.”). the california supreme court’s decision in moore vs. regents of the university of california, 792 p.2d 479, 483 (cal. 1990), similarly supported the notion that disclosure fulfills a physician’s duty to avoid acting out of self-interest at the patient’s expense in holding that the physicians failed to obtain the patient’s informed consent to their actions in furtherance of a plan to commercialize cancer cells that they had removed from the patient’s spleen: “(1) a physician must disclose personal interests unrelated to the patient's health, whether research or economic, that may affect the physician's professional judgment; and (2) a physician's failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of fiduciary duty.” 44 indiana health law review vol. 12:1 that many patients will be unable to do so: they may not have sufficient time due to the seriousness of their condition; lack sufficient resources, say, to pay for a second opinion; have inadequate education or sophistication; or be mentally incompetent or in too much pain or fear. for these patients, and undoubtedly there would be many of them, disclosing physician disloyalty would merely cause them needless mental suffering. and even patients who were able to protect themselves would be likely to be emotionally harmed by disclosure when they realized that they were not able to trust their doctors.92 another question is whether there are some conflicts of interest that are so toxic that physicians must avoid them altogether. as shepherd states: [s]ome conflicts of interest presented to the fiduciary may be so dangerous that the fiduciary should not be allowed to make the choice. this may be because the fiduciary would be too tempted by the size of the type of self-interest existing. alternatively, it may be because the fiduciary would not know when his 92 a related issue is whether patients should be able to waive their physician’s fiduciary duties. there is a vigorous debate about this in corporate fiduciary scholarship. see, e.g., larry e. ribstein, are partners fiduciaries?, 2005 u. ill. l. rev. 209, 211, n.11 (2005). assuming that the conditions that cause the patient-physician relationship to be deemed fiduciary in the first place are obtained, it is difficult to understand why waiver would be permitted, or indeed why a patient would ever freely choose to do so. one possibility is that the patient is sufficiently knowledgeable and sophisticated that they do not need fiduciary protections and can obtain some net benefit by a waiver, such as being able to enter into a relationship with a more exclusive physician. an example might be patients who themselves are physicians. but see frankel, supra note 6, at 29 (“the fact that the entrustor is an expert who chooses another expert in the same area does not reduce the entire risk of the relationship. such an expert can choose a better fiduciary, but like all others he must entrust property or power to the fiduciary, or else lose the entire benefit from the relationship.”). frankel gives as an example bernie madoff’s fleecing of sophisticated investors. 2015 why physicians are fiduciaries for their patients 45 self-interest had influenced the use of his fiduciary powers.93 examples of conflicts that have been deemed impermissible for physicians include accepting gifts from drug companies;94 federal laws against referring patients to physician-owned ancillary facilities and accepting kickbacks from non-physician-owned facilities;95 conditioning too great a proportion of physician income on bedside rationing;96 and “gag clauses,” which prohibit physicians from giving patients information that might be adverse to the patient’s health plan.97 with these ground rules in mind, the next section will examine several key cases to determine how physicians should discharge their fiduciary duty to place the patients’ welfare above their own self-interest. a. managed care refusals to pay for medically necessary care in wickline vs. state of california,98 a physician caring for a post-operative patient wanted the patient to remain in the hospital for eight days, but the patient’s health insurer only approved an additional four days. the doctor duly discharged the patient after only four days, following which complications ensued and the patient eventually lost her leg. she thereupon sued the health insurer for negligence. both the plaintiff’s and defendants’ experts agreed that, 93 shepherd, supra note 6, at 151. 94 see hafemeister & bryan, supra note 66. 95 see tim drake, alexandra kanu, & nick silverman, health care fraud, 50 am. crim. l. rev. 1131 (2013) (describing federal fraud-andabuse laws). 96 see 42 c.f.r. § 417.479 (2014) (limiting medicare physician incentive plans to no more than 25% of physician fees). 97 see kristin l. jensen, releasing managed care's chokehold on healthcare providers, 16 annals health l. 141, 149-53 (2007) (discussing efforts to prohibit gag clauses). 98 192 cal. app. 3d 1630 (2nd cir. 1986). the patient was on medicaid, but the issues raised in the case do not differ substantially depending on whether the patient is publicly or privately insured. 46 indiana health law review vol. 12:1 while the patient’s leg would have been saved had she remained the full eight days in the hospital, the discharge after only four days was not negligent, and therefore the health plan was not liable.99 but the appellate court proceeded to consider in dicta what the physician should have done if he had believed that he should not have discharged the patient after only four days, and stated: “the physician who complies without protest with the limitations imposed by a third party payor, when his medical judgment dictates otherwise, cannot avoid his ultimate responsibility for his patient's care. he cannot point to the health care payor as the liability scapegoat when the consequences of his own determinative medical decisions go sour.”100 the dicta in wickline prescribe a key aspect of what physicians must do to be loyal to their patients: they must advocate for them by seeking to persuade managed care plans to pay for the care the physicians think is required. it is important to understand that, in doing so, physicians are placing their patients’ interests ahead of their own. not only does protesting take time and effort, but managed care risk-sharing arrangements may dock a portion of physicians’ remuneration if plans believe that patients are being kept too long in the hospital, and physicians who advocate too aggressively for their patients may find themselves excluded altogether from receiving payment for caring for plan enrollees.101 how much must physicians jeopardize their own selfinterest to fulfill their fiduciary duty to act on behalf of their patients? the physician in the wickline case testified that, “had wickline's condition, in his medical judgment, been critical or in a deteriorating condition on [the fourth day], he would have made some effort to keep her in the hospital 99 the facts of the case provide a good illustration of the distinction between reasonable and optimal care discussed earlier. see supra notes 5, 9, 42, 54 and accompanying text. 100 wickline, 192 ca. app. 3d at 1645. the court proceeded to observe that, “while we recognize, realistically, that cost consciousness has become a permanent feature of the health care system, it is essential that cost limitation programs not be permitted to corrupt medical judgment.” id. at 1647. 101 the euphemism is called being “de-selected.” 2015 why physicians are fiduciaries for their patients 47 beyond that day even if denied authority by medi-cal and even if he had to pay her hospital bill himself.”102 however laudable the sentiment, it clearly exceeds the physician’s fiduciary duty since, as stated earlier, they are entitled to receive a reasonable fee for their services. beyond that, however, there can be no bright-line rule; other than avoiding certain impermissible conflicts as discussed earlier,103 all that can be said is that the more that physicians sacrifice their own self-interest, the less vulnerable they will be to being found liable for acting disloyally. a “the more the better” standard such as this may seem like an unsatisfactory answer, and no doubt physicians may find it disquieting. but the law often must resort to such indefinite rules when, as here, the scope of duty is highly fact-specific. for example, physicians unilaterally may terminate their relationship with patients so long as they give them notice and a reasonable opportunity to obtain care elsewhere,104 but what constitutes a “reasonable opportunity” will vary depending on how sick the patient is, the availability of other caregivers, and so forth. as with fiduciary duties, the most that can be said is that the longer the notice and the greater the assistance in finding alternative providers that physicians give, the less vulnerable they are to being liable for the tort of “abandoning” their patients. a variable rule such as this also is particularly apt when physicians are trying to avoid liability for being unfaithful to their patients. as lawrence mitchell argues, this type of rule “is aspirational and studiously imprecise. the very ambiguity of the language conveys its moral content as the court's refusal to set lines is designed to discourage marginal conduct by making it difficult for a fiduciary to determine the point at which self-serving conduct will be 102 192 ca. app. 3d at 1640 (emphasis added). 103 see the discussion at supra notes 78-80 and accompanying text. 104 see, e.g., payton v. weaver, 131 cal. app. 3d 38 (1st cir. 1982) (discussing how doctors may terminate relationships with patients). 48 indiana health law review vol. 12:1 prohibited, and thus to encourage conduct well within the borders.”105 it is also important to appreciate that fiduciary law gives doctors a powerful weapon against managed care plans and other entities seeking to prevent them from acting on behalf of their patients. a later california case, wilson v. blue cross of california,106 clarified the dicta in wickline to emphasize that, while a physician who does not protest a managed care plan’s denial of payment would be liable for a premature hospital discharge, so too would a managed care plan that unreasonably refused to approve a medically necessary hospital stay.107 in addition, patients may be able to hold managed care plans liable for tortious interference with the physician’s fiduciary duties 108 or aiding and abetting a physician’s infidelity.109 so by advocating for the patient, doctors can claim to be protecting these entities from liability as well as themselves. consider now another case, murray v. unmc physicians,110 decided in 2011 by the supreme court of nebraska. according to the plaintiff’s allegations, his wife was a patient hospitalized with pulmonary arterial hypertension. she was catheterized to confirm her 105 lawrence e. mitchell, the death of fiduciary duty in close corporations, 138 u. pa. l. rev. 1675, 1701 (1990). 106 222 cal. app.3d 660, 271 cal. rptr. 876. 107 id. at 671-674. 108 see rome indus., inc. v. jonsson et al., 415 s.e.2d 651, 652 (ga. ct. app. 1992) (“in this case, rome alleged appellees induced one of its officers to breach his fiduciary duty to rome. in essence, the claim is one for tortious interference with contractual rights. the trial court erred in granting summary judgment to appellees on the ground the allegation fails to state a claim.”). 109 see halo tech holdings, inc. v. cooper, 2008 wl 877156, at *20 (d. conn. mar. 26, 2008) (“to sustain a claim for aiding and abetting a breach of fiduciary duty, a plaintiff must allege that: ‘(1) the party whom the defendant aids must perform a wrongful act that causes an injury; (2) the defendant must be generally aware of his role as part of an overall illegal or tortious activity at the time that he provides the assistance; (3) the defendant must knowingly and substantially assist the principal violation.’”). 110 806 n.w.2d 118 (neb. 2011). http://dx.doi.org/10.2307/3312302 2015 why physicians are fiduciaries for their patients 49 diagnosis and eligibility for treatment with flolan, a vasodilator that, once begun, cannot be stopped without lifethreatening consequences. the doctors confirmed the diagnosis, but since the drug cost approximately $100,000 a year, they delayed the start of treatment while waiting for the patient’s health insurer to agree to pay for it. before they received word back from the insurer, the patient died. the patient’s husband sued the doctors and the hospital for medical malpractice. (he was unable to sue for breach of fiduciary duty because nebraska is one of the ten states that follows the pegram decision and recognizes no cause of action for a fiduciary breach aside from medical malpractice.111) but consider what the outcome should be if the plaintiff had been able to sue for breach of fiduciary duty. the trial judge ruled that delaying care pending assurance of payment was impermissible; the notion that “the standard of care is different for those with money than for those without,” the judge stated, “is neither moral nor just. it is wrong.”112 the supreme court of nebraska overruled the trial judge, however, stating that the physicians did not delay the treatment for economic reasons but because they made a medical determination in the patient’s best interests: this case does not involve a conflict of interest between the physician and patient—there was no evidence, for instance, of a financial incentive for unmc's physicians to control costs. as explained by unmc's witnesses, the decision to defer flolan treatment was not based on its financial effect on unmc, or 111 see discussion supra notes 40-48 and accompanying text. 112 murray, 806 n.w.2d at 121. the trial judge also stated: “this court is of the opinion that, as a matter of law, a medical standard of care cannot be tied to or controlled by an insurance company or the need for payment. the ‘bean counters’ in an insurance office are not physicians. medicine cannot reach the point where an insurance company determines the medical standard of care for the treatment of a patient. nor, can we live in a society where the medical care required is not controlled by the physicians treating the patient.” id. 50 indiana health law review vol. 12:1 subordinating mary's well being to the interests of other patients, or even considering mary's own financial interest. instead, when making its initial value judgment regarding mary's treatment, unmc's physicians were not weighing the risk to mary's health against the risk to her pocketbook, or unmc's budget, or even a general social interest in controlling health care costs. unmc's physicians were weighing the risk to mary's health of delaying treatment against the risk to mary's health of potentially interrupted treatment. stated another way, this was not a case in which a physician refused to provide beneficial care—it was a case in which the physicians determined that the care would not be beneficial if it was later interrupted. in fact, it could be deadly.113 the court’s reasoning is questionable to say the least in assuming that the physicians would have stopped the treatment later if the insurer had refused to pay and in presuming that they could have done so without being liable for the patient’s wrongful death.114 but the case nevertheless raises the question of what the doctors should have done to fulfill their fiduciary duty to the patient. based on the previous discussion of the wickline decision, the doctors in murray clearly were not required to start the patient on the expensive drug and then pay for it out of their own pockets if the patient’s insurer later refused. moreover, as stated earlier, decisions about whether patients in the plaintiff’s circumstances are entitled to such an expensive and potentially only 113 id. at 126 (emphasis in original) (footnotes omitted). 114 the physicians might be able to show that they did not breach their fiduciary duty to the patient if they could prove that they withheld the drug to spare the patient the cost of paying for it out-of-pocket if the insurer declined, especially if they also had been willing to discount their own fee for the service, but there was no indication that this was the case. 2015 why physicians are fiduciaries for their patients 51 marginally effective treatment115 ideally should be made by a public body rather than by physicians at the proverbial bedside. but since the nation has not yet come to accept such an enlightened approach, what should doctors do in the meantime? the answer based on wickline is that the doctors must not just sit back passively and wait for the health insurer to make its coverage determination, but must advocate for the patient. there were a number of ways for them to do this: they could “protest,” in this case making an effort to persuade the insurer to make an especially rapid decision; approach the hospital where the patient was being treated to see if it would agree to cover the cost of the drug as “charitable care”; and appeal to the drug manufacturer to provide the drug at a discount, as the defendants’ own expert testified he would have done.116 there is no indication in the case that her doctors took any of these steps, much less that, pursuant to the “more is better” standard, they did so with sufficient vigor to avoid liability. the lessons from the wickline and murray cases provide guidance for physicians when managed care plans refuse to cover the patient’s care. but plans can create incentives for doctors to take these decisions out of the hands of the plan, that is, to engage in bedside rationing. how should doctors behave under those circumstances in order to discharge their fiduciary duty to their patients? 115 see cheng-huai ruan et al., prostacyclin therapy for pulmonary arterial hypertension, 37 tex. heart inst. j. 391, 396 (2010) (“although this therapy improves physical function and survival, it has significant drawbacks and results in limited improvements in quality of life.”). 116 murray, 806 n.w.2d at 121 (“[a]nother of unmc's experts, william johnson, m.d., explained that the standard of care required finding some source of payment for a patient, but that if insurance was unavailable, it was still usually possible to find some other payment on a ‘compassionate need basis’ within the 12–week timeframe that johnson opined was appropriate for treatment of chronic pulmonary arterial hypertension.”). 52 indiana health law review vol. 12:1 b. physician behavior under managed care risk-sharing arrangements the facts in the neade case discussed earlier provide a context for considering how physicians ought to discharge their fiduciary duty to the patients when the physicians are given financial incentives to withhold care.117 recall that the physicians in neade were alleged to be globallycapitated by the patient’s managed care plan, meaning that they had to pay for any tests provided by non-plan providers out of a $75,000 annual allotment, and that, according to the plaintiff, they declined to order an out-of-plan angiogram for the patient and did not disclose their financial arrangement with the plan to the patient, which would have prompted him to obtain a second opinion about the need for the life-saving test. the court, it will be recalled, followed the dicta in the pegram case and refused to allow the plaintiff to assert a cause of action for breach of fiduciary duty, but what if it had? what should the physicians have done to avoid liability? as the supreme court in pegram demonstrated, courts are not likely to rule that incentive plans that reward physicians for limiting spending are per se violations of their fiduciary duty to their patients. however, given the procedural advantages enjoyed by plaintiffs in breach-offiduciary-duty cases discussed earlier,118 once plaintiffs present evidence demonstrating the existence of such an incentive arrangement, the burden should shift to physicians to prove that they did not act improperly. for example, the physician could show lack of causation, in that any harm or lack of benefit suffered by the patient was unavoidable; that the amount at stake for the physician by virtue of the incentive plan was within the limits of the physicians “reasonable fee” or too small to have affected the doctor’s behavior119; or, per wickline, that the physician had 117 see supra part i(a)(3). 118 id. 119 see e. haavi morreim, benefits decisions in erisa plans: diminishing deference to fiduciaries and an emerging problem for provider-sponsored organizations, 65 tenn. l. rev. 511, 551-552 2015 why physicians are fiduciaries for their patients 53 vigorously advocated for the patient against the plan despite the financial consequences for the physician.120 the cases discussed so far describe a number of ways in which the structure and function of the health care system challenges the fulfillment of physicians’ fiduciary duties. but the health care system is undergoing a period of rapid change. the next section considers whether these changes increase or reduce the patient’s need for physician loyalty. iv. why it is especially important for patients at this time for physicians to be fiduciaries as described earlier, the patient-physician relationship easily fulfills the conditions that justify making one party a fiduciary for another. what is important to understand is how changes taking place in medical practice, delivery, and financing are making fiduciary protections for patients all the more important. medical science is becoming increasingly complex and harder for laypersons to comprehend, making it more imperative for patients to be able to obtain disinterested information from physicians.121 the availability of medical (1998) (“one approach asks the court simply to review the merits of the interpretation to determine whether it is consistent with an exercise of discretion by a fiduciary acting free of the interests that conflict with those of the beneficiaries . . . . if a given decision under a particular contract would be acceptable in the absence of any conflict, then that same decision within that same contract should be acceptable, even if a conflict is present.”). 120 moreover, although as noted earlier it is theoretically possible to establish a breach even if the physician’s actions do not constitute malpractice, the strongest case would be if the physician’s behavior was negligent as well as disloyal. 121 see isaac s. kohane et al., a glimpse of the next 100 years in medicine, 367 new eng. j. med. 2538, 2538 (2012) (“in the decades ahead, the pace of biomedical discovery will accelerate . . . . the size and complexity of this multidimensional characterization of patients will lead to far more complex diagnostic and prognostic categories than are currently in use . . . . the high-technology, information-rich medicine of the future will provide powerful and useful tools for clinical medicine.”); diane swanbrow, u.s. public's knowledge of science still has a long way to go, phys org (feb. 16, 2011), (http://phys.org/news/2011-02http://dx.doi.org/10.1056/nejme1213371 54 indiana health law review vol. 12:1 knowledge on the web is only partially offsetting, since the data may be inaccurate, conflicting, or difficult for readers to evaluate.122 the more vulnerable patients are due to poverty or lack of education, moreover, the less likely they are to have access to the internet or to be able to understand the information that it contains.123 the knowledge-science.html, archived at http://perma.cc/6lv6-racf) (“in 1988, just 10 percent of u.s. adults had sufficient understanding of basic scientific ideas to be able to read the tuesday science section of the new york times, according to jon miller, a researcher at the u-m institute for social research (isr). by 2008, 28 percent of adults scored high enough to understand scientific ideas at that level. despite the improvement, the american public has a long way to go . . . .”). 122 see shawna l mcnally et al., can consumers trust web-based information about celiac disease? accuracy, comprehensiveness, transparency, and readability of information on the internet, 1 interactive j. med. research e1 (2012) (archived at http://perma.cc/p34h-66f4) (“the information on many websites addressing celiac disease was not sufficiently accurate, comprehensive, and transparent, or presented at an appropriate reading grade level, to be considered sufficiently trustworthy and reliable for patients, health care providers, celiac disease support groups, and the general public.”); gretchen k. berland et al., health information on the internet accessibility, quality, and readability in english and spanish, 285 jama 2612 (2001) (“accessing health information using search engines and simple search terms is not efficient. coverage of key information on englishand spanish-language web sites is poor and inconsistent, although the accuracy of the information provided is generally good. high reading levels are required to comprehend web-based health information.”). 123 see namkee g choi & diana m dinitto, the digital divide among low-income homebound older adults: internet use patterns, ehealth literacy, and attitudes toward computer/internet use, 15 j. med. internet research e93 (2013) archived at http://perma.cc/42qdr4yr (“this study is the first to describe in detail low-income disabled and homebound adults' and older adults' internet use. it shows very low rates of internet use compared to the us population . . . .”); emily z kontos et al., barriers and facilitators to home computer and internet use among urban computer users of low socioeconomic position, 9 j. med. internet research e31 (2009): e31, archived at http://perma.cc/5rlc-skcs (“despite the increasing penetration of the internet and amount of online health information, there are significant barriers that limit its widespread adoption as a source of health information. one is the ‘digital divide,’ with people of higher socioeconomic position (sep) demonstrating greater access and usage compared to those from lower sep groups.”). http://dx.doi.org/10.2196/ijmr.2010 http://dx.doi.org/10.1001/jama.285.20.2612 http://dx.doi.org/10.2196/jmir.2645 http://dx.doi.org/10.2196/jmir.9.4.e31 2015 why physicians are fiduciaries for their patients 55 conversion from paper to electronic medical records also can complicate patients’ ability to know and understand their health states, since information that once was available more or less in chronological order in one place may now be arranged in a more confusing manner, and key pieces of data may be available only through links to other records in the provider’s electronic database, which is not likely to be readily accessible to patients.124 in addition, the classic primary care relationship that lasted over time and in which patient visits often were quite lengthy is giving way to fleeting encounters with random clinicians and multiple specialists who may give patients fragmentary or inconsistent information.125 at the same 124 see am. hosp. ass’n, hospitals face challenges using electronic health records to generate clinical quality measures 5-6, available at http://www.aha.org/research/policy/ecqm.shtml (“ehrs are not designed to capture information from other department information systems at the level of detail needed for ecqm reporting . . . ehrs and certification requirements are not designed to support effective and efficient patient care workflows or draw data from them.”); oladimeji farri et al., a qualitative analysis of ehr clinical document synthesis by clinicians, am. medical informatics ass’n annual symposium proceedings archive 1217 (2012) archived at http://perma.cc/dzh4mg2x (“trending of past medical diagnoses, medications, and laboratory values were particularly difficult due to poor alignment of dates or incongruent organization of relevant patient information . . . .”). 125 see susan okie, the evolving primary care physician, 366 new eng. j. med. 1849, 1849, 1850 (2012) (“[i]n recent years, the pressure on physicians to move quickly and accomplish multiple goals during a visit has intensified, mechanic said. in surveys, many patients describe their doctors as hurried and unresponsive.”); ateev mehrotra et al., dropping the baton: specialty referrals in the united states, 89 milbank q. 39, 39 (2011) (“many referrals do not include a transfer of information, either to or from the specialist; and when they do, it often contains insufficient data for medical decision making. care across the primaryspecialty interface is poorly integrated . . . .”); peter k. lindenauer et al., outcomes of care by hospitalists, general internists, and family physicians, 357 new eng. j. med. 2589, 2589 (2007) (“[t]he hospitalist model introduces handoffs at the time of admission and at discharge, transitions during which the risk of errors and adverse events is high.”). efforts to establish “accountable care organizations” and “medical homes” to enable greater coordination of care and centralization of responsibility are a partial response to this fragmentation, but it remains to be seen how effective or widespread they will be. 56 indiana health law review vol. 12:1 time, changes occurring in how medical care is delivered make patients more vulnerable to being harmed by physician disloyalty. increasing numbers of physicians are being employed by hospitals and other health care institutions, for example, creating new conflicts of interest with their patients.126 finally, the push for patients to assume a greater share of the cost of care through higher deductibles, coinsurance, and copayments gives them more at stake and places a greater burden on them to make wise health care decisions.127 in sum, current trends in the delivery of health care make the fiduciary nature of the patient-physician relationship all the more important for patients. patients need to be able to depend on their physicians to act in their interest and give them trustworthy advice in order to try to navigate the increasingly challenging health care environment that they face. but the preceding sections admittedly show that acting loyally toward patients imposes burdens on physicians, some of which can be quite 126 see robert a. berenson et al., hospital-physicians relations: cooperation, competition, or separation?, 26 health aff. w31, w31w33 (2007) (“hospitals and medical staff physicians face growing tensions as a result of physicians’ growing reluctance to take emergency department call and the consequences of hospitalists replacing physicians in the care of inpatients . . . . hospital-physician relations were perceived to be under greater strain in 2005 than in 2000–01.”). 127 see sheila r. reddy et al., impact of a high-deductible health plan on outpatient visits and associated diagnostic tests, 52 med. care 86, 86 (2014) (“the rapid expansion of high-deductible health plans (hdhps) over the last decade is transforming the us insurance marketplace, yet understanding of their impact on access to care remains limited. from 2006 to 2012, the percentage of covered employees enrolled in a plan with at least a $1000 deductible more than tripled from 10% to 34%. among small firms, nearly 50% of workers were enrolled in hdhps in 2012 . . . . hdhps shift costs to members by requiring full out-of-pocket payments for many services until an annual deductible has been met.”) (footnotes omitted); robert s. huckman & mark a. kelley, public reporting, consumerism, and patient empowerment, 369 new eng. j. med. 1875, 1876 (2013) (“once shielded from health care costs, consumers are now seeing those bills eat further into their family budgets. that new awareness may explain why the number of physician visits among privately insured patients fell 17% nationally between 2009 and 2011.”). http://dx.doi.org/10.1377/hlthaff.26.1.w31 http://dx.doi.org/10.1097/mlr.0000000000000008 http://dx.doi.org/10.1056/nejmp1310419 2015 why physicians are fiduciaries for their patients 57 significant, which may lead physicians to demur. as the next and final section explains, however, reaffirming the fiduciary nature of the relationship is as critical for physicians as it is for patients. v. why reaffirming their fiduciary status is necessary for physicians regarding physicians as fiduciaries for their patients is essential not only for patients but for physicians. in order to appreciate why, it is necessary to know the history of the american medical profession. prior to the nineteenth century, medical care was delivered by a highly fragmented and contentious group of providers.128 beginning in the twelfth and thirteenth centuries, a small number of physicians obtained positions at the emerging universities and were regarded, along with university-based men of the law and the clergy who governed the universities, as “learned professionals.”129 but these physicians exclusively treated the aristocracy, on whose patronage they depended.130 “the vast bulk of the population,” explains toby gelfand, “constituted by the rural masses and urban poor, had little access to physicians.”131 instead, their medical care was furnished by a hodge-podge of barber-surgeons, apothecaries, surgeonapothecaries (the forerunners to the modern english “general practitioner”132), midwives, and “specialists” such 128 the discussion that follows pertains to the medical profession in western society. 129 see toby gelfand, the history of the medical profession, in companion encyclopedia of the history of medicine, vol. 2, at 1121 (w. f. bynum & roy porter, eds. 1993) (describing early history of university-based physicians). 130 id. at 1122 (“learned medical professionals drew their clients from among the only members of society who could afford their fees, the narrow segment of upper classes.”). 131 id. 132 edward shorter, the history of the doctor-patient relationship, in companion encyclopedia of the history of medicine, vol. 1, at 784 (w.f. bynum and roy porter, eds. 1993). 58 indiana health law review vol. 12:1 as tooth-drawers.133 some organized themselves into medieval craft guilds,134 which owed their allegiance to the state rather than to their patients.135 another class of healers, the members of “colleges” of physicians, developed in some non-university cities in response to the absence of university-based practitioners.136 with the exception of the university-based and some urban physicians, medical practitioners generally enjoyed relatively low social and economic status. well into the nineteenth century in britain, for example, they were socially inferior to lawyers, clergymen, and the military.137 patients avoided medical providers as much as possible. “for the traditional patient,” explains one historian of medicine, “access to medicine meant really procuring a prescription for some complex purgative the patient could not compound or as a last desperate resort in terminal illness.”138 in the american colonies, the role of physician and surgeon had been merged, but doctors still enjoyed relatively low socio-economic status. as bioethicist and physician edmund pellegrino observes, medicine was characterized by “venal physicians, charlatans, and internecine dissension.”139 133 gelfand, supra note 130, at 1122. 134 id. 135 id. at 1128. in the 18th century, the influence of laissez-faire economics encouraged a more entrepreneurial approach to medicine that undermined the power of the guilds. id. at 1130. 136 id. at 1124. the london college of physicians, for example, was chartered by henry viii in 1518. id. at 1125. baker notes that the colleges were not academic institutions “but rather licensing organizations.” robert baker, before bioethics: a history of american medical ethics from the colonial period to the bioethics revolution 95 (2013) [hereinafter baker, before bioethics] 137 id. at 1135 138 shorter, supra note 132, at 787. 139 edmund d. pellegrino, one hundred fifty years later: the moral status and relevance of the ama code of ethics, in the american medical ethics revolution: how the ama’s code of ethics has transformed physicians’ relationships to patients, professionals, and society 107 (robert b. baker et al. eds. 1999) [hereinafter baker]. 2015 why physicians are fiduciaries for their patients 59 it was only when the ama was formed and adopted its first code of ethics in 1847 that we see the birth of a new conceptualization of the physician: as a professional.140 the code sought to dispel the popular perception that physicians were interested primarily in their own welfare. “the central moral commitment of the code,” states edmund pellegrino, “was its dedication to something other than the physician’s self-interest, that something being the primacy of the welfare of the patient. this was a necessary reaffirmation given the self-serving conduct of the physician at this time.”141 although the code did not use the term “fiduciary” to describe the patient-physician relationship, there was no mistaking its emphasis: the first section states that “physicians should . . . minister to the sick with due impressions of the importance of their office; reflecting that the ease, the health, and the lives of those committed to 140 see baker, before bioethics, supra note 136, at 17 (the ama made a series of decisions “by which it introduced content into the yetto-be-defined concepts of ‘professionalism’ and ‘professional ethics’”). during the eighteenth century, john gregory and thomas percival, professors at edinburgh university, wrote tracts on physician ethics, but they were grounded on gentlemanly virtues rather than professionalism. see chester r. burns, setting the stage: moral philosophy, benjamin rush, and medical ethics in the united states before 1846, in baker, supra note 139, at 7. (“for both gregory and percival, the character of a gentleman determined a physician’s moral propriety.”). baker similarly states that the gentlemanly ethic held sway in the united states until the middle of the nineteenth century. baker, before bioethics, supra note 136 at 53. lawrence mccullough traces the emergence of medical professionalism to gregory, however: “gregory also forged the ethical concept of a professional, i.e., someone who lives primarily according to fiduciary obligations of service to patients rather than primarily according to the dictates of self-interest. gregory thus helped to invent medicine as a fiduciary profession, a legacy that persists into our time. gregory did so in response to the state of disarray in the medicine of his day, a disarray that he meant to set to rights by using the tools of moral philosophy and philosophy of medicine.” lawrence b. mccullough, introduction, in john gregory's writings on medical ethics and philosophy of medicine 1 (laurence b. mccullough ed., 1998). mccullough’s argument is repeated by charity scott. see scott, supra note 6, at 335-337. 141 pellegrino, supra note 139, at 110. 60 indiana health law review vol. 12:1 their charge, depend on their skill, attention and fidelity.”142 as a result of its embrace of professionalism, by the second decade of the twentieth century, the medical profession in the united states had become the most powerful profession in the country.143 the ama controlled medical education and licensure.144 physicians had become highly respected and their earnings began to increase. now consider that the legal concept of a fiduciary has a long pedigree, going back to roman law.145 the term was first used by english authors to describe a trustee in 1640.146 but the first time that a legal opinion used the term “fiduciary” to describe a physician was an american case in 1848, one year after the ama adopted its new code.147 (the first case in britain was in 1858.148) this is 142 code of medical ethics of the american medical association, ch. 1, art, 1, §1 (1847) available at http://www.amaassn.org/resources/doc/ethics/1847code.pdf (emphasis added). much of the code was a revival of hippocratic principles. see pellegrino, supra note 139, at 109. 143 see gelfand, supra note 129, at 1142. 144 id. at 1142; see maxwell j. mehlman, professional power and the standard of care in medicine, 44 ariz. st. l. j. 1165, 1169-1175 (2012) (provides description of the developments in self-regulation). a considerable degree of professional prestige came from the embrace of scientific medicine. shorter, supra note 132, at 789-791. 145 see susan atherton, mark blodgett &charles atherton, 2 j. religion & business ethics art. 5 (2011) archived at http://perma.cc/ptn6-ck78 (describing the roman concept of fiducia). 146 3 william blackstone, commentaries on the laws of england *122 (“the neglect or unskillful management of his physician . . . . breaks the trust which the party has placed in his physician . . . .”). 147 crispell v. dubois, 4 barb. 393, 395-96, 1848 wl 5096 (n.y. gen. term 1848) (“as in this case, the alleged will was prepared by an individual standing in a fiduciary relation to the deceased, and who took a large benefit under the will, more was required than bare proof of the execution . . . .that as the plaintiff had long acted as the agent and confidential adviser of the deceased, and as her physician, and was attending her in that capacity . . . .”). michelle oberman incorrectly asserts that “[w]idespread adoption of fiduciary terminology in reference to doctors and patients began in the 1980s.” michelle oberman, mothers and doctors’ orders: unmasking the doctor’s fiduciary role in maternal-fetal conflicts, 94 nw. u. l. rev. 451, 455 (2000). however, she then acknowledges that “courts have termed the physician-patient relationship a ‘fiduciary’ one since at least the mid-1960s.” id. at 456 2015 why physicians are fiduciaries for their patients 61 not a coincidence. the law conferred the status of a fiduciary on doctors at the very same time that they had begun refashioning themselves into a true profession. in other words, the law was saying that, if physicians want to be professionals, they had to act as fiduciaries for their patients. arguably this works both ways: if doctors are no longer fiduciaries, they are no longer professionals. towards the end of the previous century, there began a substantial erosion of physician power that continues to this day, due in large part to society’s distress at an enormous increase in health care spending attributed in no small part to the economic incentives for physicians created by the traditional fee-for-service payment system. in response, health care increasingly has come to be dominated by nonphysicians. the result for physicians is a loss of independence and self-regulatory authority. a renowned scholar of the professions, eliot freidson, describes current developments that challenge medical professionalism, including that: [p]hysicians now depend for their income on government agencies, large corporate employers, and health insurance companies, and must usually accept the economic terms offered by those organizations; an increasing number of physicians work for a salary or on a (citing hammonds v. aetna cas. & sur. co., 243 f.supp. 793, 799 (n.d. ohio 1965). frankel similarly seems to think that regarding physicians as fiduciaries for their patients is a recent development: “the twentieth century is witnessing an unprecedented expansion and development of the fiduciary law. for example, physicians and psychiatrists have recently become members of the fiduciary group . . . .” frankel, supra note 1, at 796. 148 hoghton v. hoghton (1852) 15 beav. 278, 287-88 (ch.), 51 eng. reprint, 545 (“the rule in cases of fiduciary relations as between trustee and cestui que trust , solicitor and client, guardian and ward, priest and penitent, physician and patient, which throws on the party receiving a benefit the onus of proving the fairness of the transaction, has no application to the present case.”). 62 indiana health law review vol. 12:1 capitation basis in circumstances organized and financed by large for-profit organizations; [and] physicians are being divided into clinical practitioners, on the one hand, and managers or owners of practice organizations, on the other.149 freidson fears that these changes “have the potential to destroy professionalism in medicine and to reduce physicians to technicians.”150 the message then is clear: if physicians want to regain and sustain their status as professionals, it is imperative for them to reaffirm their status as fiduciaries for their patients. as pellegrino states, the challenge is to reassert “the primacy of the patient’s welfare”: together we must insist that no public policy, no practice arrangement, no professional prerogative, no definition of roles that weakens our primary loyalty to the patient can be allowed to dilute that commitment. . . . fidelity to the moral center of medicine is the only antidote to the moral malaise that afflicts our professional today. we do not need a “new” ethic of accommodation to economics, commerce, or the idolatry of the marketplace. even less do our patients need such an ethic.151 physicians may not like being subject to potential legal liability for breaching their fiduciary duties to patients, viewing it as just another attempt by meddlesome lawyers to complicate their lives. but in doing so, they would be making a grave mistake by not appreciating the connection between fiduciary duty and the benefits that accrue to being professionals, especially the professional prerogative of selfregulation. 149 eliot freidson, professionalism and institutional ethics, in baker, supra note 139, at 132. 150 id. 151 pellegrino, in baker, supra note 139, at 120.) 2015 why physicians are fiduciaries for their patients 63 a recommitment to their role as fiduciaries, moreover, would help physicians shield themselves from current efforts to transform medicine from a calling into a mere business enterprise: physicians could point to the threat of legal liability as a reason to avoid arrangements that would pit their interests against those of patients. of particular importance is the suggestion mentioned earlier that entities such as managed care plans and hospitals that placed physicians into and enforced such arrangements might be liable independently for interfering with the physician’s fiduciary duties.152 by reaffirming their fiduciary duty to patients, physicians therefore can point to the fact that they are protecting these entities as well as themselves from potential liability. vi. conclusion if physicians are going to be able to hold onto their hardwon status as professionals, they need to begin acting now to remake the american health care system so that it is compatible with their fiduciary duties to their patients. success will not come easily. the restructuring of medicine according to a business rather than a professional model may have gone too far to be turned back. physicians may have trouble dissuading the public from the impression that they are asserting their fiduciary obligations merely as an excuse to enhance their own self-interest. to save both their patients and their profession, however, physicians have no choice but to try. 152 see supra part ii(a). microsoft word 1-volume xii masthead.docx transformations in health law practice: the intersections of changes in health care and legal workplaces louise g. trubek, barbara zabawa, paula galowitz* i. introduction ..................................................................... 184 ii. background and context for health law practice ..... 185 a. health care system changes .................................... 186 b. legal services in flux ................................................ 188 iii. health law workplace sites ..................................... 191 a. outside and inside: in-house counsel and corporate law firms .................................................................. 191 1. increasing reliance on in-house counsel ................ 194 2. defining the roles of the outside health lawyer ... 197 b. expanding medical-legal partnerships ................... 202 iv. learning from the workplaces: reconstructing lawyers’ professionalism identity ..................................... 209 a. expertise .................................................................... 210 1. legal expertise for improved patient-centered care ................................................................................ 211 2. legal expertise to resolve complaints ................... 212 3. legal expertise to strengthen business decisions ... 213 b. roles: the lawyer as colleague with physicians and other professionals ................................................... 214 c. communities of practice ........................................... 218 v. training for practice ...................................................... 220 vi. conclusion ..................................................................... 225 * louise trubek, clinical professor of law emerita, university of wisconsin law school; barbara zabawa, owner of the center for health law equity, llc; paula galowitz, clinical professor of law emerita, new york university school of law. the authors would like to thank laura green for her invaluable research assistance. also, the authors would like to thank the madison roundtable participants for their insightful comments, including sarah davis (university of wisconsin law school), erika lopez (legal action of wisconsin), paul van den heuvel (mercy health system), christine senty (unity health), christine witherill (wps health insurance), dennis purtell (whyte hirschboeck dudek), and kim shaul (national guardian life insurance). http://dx.doi.org/10.18060/18962 184 indiana health law review vol. 12:1 i. introduction the practice of health law is undergoing radical restructuring in the wake of major changes in the health care system and the reorganization of the legal profession. the health care system is being transformed as the affordable care act (aca) promotes shifts in how health care should be delivered and financed. these shifts come at a time when the legal profession is also undergoing significant transformations. the intersection between health care changes and professional legal services can be examined by focusing on health law workplaces. this paper discusses three workplace sites where lawyers are developing or revising practices that respond to the evolving health care system. these workplace sites are in-house counsel, corporate law firms, and medical-legal partnerships. this paper describes how in-house counsel are growing and incorporating compliance and business advising into their practice. corporate law firms are developing niches where their independent advising is valued. medical-legal partnerships are expanding and using their close interactions with the health system to change their relationships with health care professionals and to provide increased legal expertise to patients. this analysis reveals how the professional identities of the lawyers are evolving as their practices change. this paper discusses three aspects: rethinking how expertise assists clients; the role of lawyer as collaborator with other professionals; and how communities of colleagues in similar practice facilitate the development of revised professional identities. finally, this paper focuses on how training, especially legal education can reflect and adapt to these workplace practices. in this period of re-thinking legal education, perhaps the health practice stories can cast some light and assist in the re-visioning of legal education. 2015 transformations in health law practice 185 ii. background and context for health law practice health law is a significant field of specialization. for example, there are specialized law journals in health law; certificate programs in health law within the juris doctor (jd) curriculum at law schools; joint degree programs with schools of public health; and organized bar committees for health law practitioners.1 recently, the media have identified health law as one of the few growing areas of the legal profession.2 one reason for the predicted growth is the enactment and implementation of the aca. since its enactment in 2010, the aca has been in the news, most recently because of its rocky rollout.3 however, the 1 see e.g., health law journals, findlaw, http://stu.findlaw.com /journals/health.html, archived at http://perma.cc/b2fy-r253 (last visited dec. 27, 2014); formal jd/mph degree programs, law, science & public health program site, http://biotech.law.lsu.edu /courses/ph_courses/jd-mph01.htm, archived at http://perma.cc/z2t2tgax (last visited dec. 27, 2014); health law programs, am. health lawyers ass’n, http://www.healthlawyers.org/hlresources/academics /lawprofessors/pages/healthlawprograms.aspx, archived at http://perma.cc/74e7-2hp2 (last visited dec. 27, 2014); health law section, american bar ass’n, http://www.americanbar.org/groups /health_law.html (last visited dec. 27, 2014); see also am. health lawyers ass’n, http://www.healthlawyers.org/pages/default.aspx, archived at http://perma.cc/8f7m-n7eb (last visited dec. 27, 2014). 2 delece smith-barrow, a changing health industry offers opportunities for lawyers, u.s. news & world report (nov. 25, 2013), http://www.usnews.com/education/best-graduate-schools/top-lawschools/articles/2013/11/25/a-changing-health-industry-offersopportunities-for-lawyers, archived at http://perma.cc/9akg-swwd; see also mike stetz, super hot: health law, 23 the nat’l jurist 8 (2014). 3 see e.g., timothy stoltzfus jost & simon lazarus, obama’s aca delays – breaking the law or making it work? 370 new eng. j. med 1970 (2014). the affordable care act is creating short-term crises that are well publicized. these delays and modifications create confusion for patients, providers, and health care organizations. some of these are the employer mandate delay, 2014 open enrollment period delays, changes in the department of health and human services (dhhs) right to renew existing plans, modifying requirements “encouraging” insurers to allow people flexibility in enrollment, and delay in nondiscrimination provision. these crises are likely to be of short duration, though of significant concern for lawyers and their clients. http://dx.doi.org/10.1056/nejmp1403294 186 indiana health law review vol. 12:1 importance of the legislation is not the short-run delays and confusion; it is the proposed long-term goals for health care. a. health care system changes the aca promotes health care improvements through encouraging seven shifts in how health care is delivered and financed. these shifts include movements toward: 1) patient-centered, collaborative care; 2) value-based and evidence-based care; 3) integrated regional clinics and hospitals; 4) integration of prevention and community medicine; 5) a computerized and benchmarked business model; 6) transparency and information sharing in health care; and 7) universal coverage using public-private systems. the first is the shift from doctor as expert to patientcentered and multiprofessional collaboration. the shift towards patient-centered care places discussion and coordination with the patient and family as a key part of treatment, minimizing unnecessary treatment and adverse reactions.4 multiprofessional collaboration involves members of different health care disciplines and perspectives, working together and supplementing each other’s expertise to determine the best treatment for a patient. the second is the change from volume-based payments to valueand evidence-based treatment. there is a shift from payments based on the amount of treatment the patient receives to payments based on the benefit the patient receives from treatment, and decisions that are based on evidence of effectiveness.5 a value-based model is touted as improving patient outcomes, creating 4 james rickert, patient-centered care: what it means and how to get there, health affairs blog (jan. 24, 2012), http://healthaffairs.org/blog/2012/01/24/patient-centered-care-what-itmeans-and-how-to-get-there/, archived at http://perma.cc/t8np-ublv. 5 gloria n. eldridge & holly korda, value based purchasing: the evidence, am. j. managed care (aug. 9, 2011), available at http://www.ajmc.com/publications/issue/2011/2011-8-vol17n8/ajmc_11aug_eldridge_e310to13/1, archived at http://perma.cc/6utrmmld. 2015 transformations in health law practice 187 accountability, being cost efficient, as well as reducing inequities.6 the third change in health care delivery and evaluation is the dramatic shift from doctors and hospitals as separate legal institutions to integrated regional clinics and hospitals. integrated regional clinics serve as the “one stop shop” for health care, where clinicians from various disciplines will be in the same place. these clinicians work in multidisciplinary teams to ensure the best patient outcome. fourth, instead of public health as a separate field, there is integration of prevention and community medicine with acute care medicine, such as that traditionally provided by hospitals and physician clinics. community medicine focuses on the health care needs of a specific group or population.7 preventive treatment is determined and provided based on that analysis.8 the fifth shift in health care is from the business of health care as small practices and unconnected care to a computerized and benchmarked business model. a benchmark business model creates a set of “best practices” and standards.9 this creates a uniform set of standards and goals to be met by hospitals and practitioners.10 the sixth shift is from health care as an opaque separate world to one of transparency and information sharing. moving towards a system of transparency, consumers will be provided with cost and quality information in order to choose health care providers. consumers taking an active role in health care decisions will lead to increased 6 id. 7 mary a. pittman, as country moves closer to near-universal coverage, community health and prevention must become focus of healthcare, public health institute blog (oct. 1, 2013), https://www.phi.org/news-events/545/as-country-moves-closer-to-nearuniversal-coverage-community-health-and-prevention-must-becomefocus-of-healthcare, archived at https://perma.cc/3eyx-2ugu. 8 id. 9 pietro giorgio lovaglio, benchmarking strategies for measuring the quality of healthcare: problems and prospects, 2012 the scientific world j. 1 (2012). 10 id. http://dx.doi.org/10.1100/2012/606154 188 indiana health law review vol. 12:1 competition and premium savings in the health care system. one way in which transparency is increased is the requirement in the aca that health plans submit information on “cost-sharing and payments with respect to any out-of-network coverage,”11 with periodic disclosure of financial information.12 the last shift in health care delivery and evaluation is the one from uninsured and safety net care to universal coverage using public-private systems. safety net care is providing the uninsured with health care through a variety of different providers, such as free clinics and public hospitals. this safety net system of treatment for the uninsured has become a patchwork system with very little coordination. universal health coverage is accomplished by expanding public and private insurance coverage and care by mandates, subsidies, payment reform encouraging care coordination, and insurance exchanges. b. legal services in flux at the same time that the health care system is struggling to become integrated, transparent, and collaborative, the organization of the delivery of legal services is also undergoing changes. the legal profession is often described as two hemispheres: personal services and business practice. there are changes in the practice of each hemisphere. in the business practice sphere there is the growth of in-house counsel offices. in the personal services sphere, there is increased concern about the lack of access to legal services. according to one legal scholar, large companies continue to increase the number of attorneys employed in-house.13 some legal scholars believe that lawyers on the inside of an 11 42 u.s.c. § 18031(e)(3)(a)(vii) (2015). 12 id. § 18031(e)(3)(a)(i)-(v) (2015); memorandum from laura green, student research assistant, seton hall university school of law, for louise trubek, clinical professor of law emerita, university of wisconsin law school (jan. 6, 2014) (on file with author and recipient). 13 interview with kathleen m. boozang, associate dean and professor of law, seton hall univ. sch. of law (dec. 11, 2013). 2015 transformations in health law practice 189 entity are better equipped to give advice because they understand the company’s business and therefore know which guidance and news is relevant to the company, and which is not.14 in 1980, approximately ten percent of licensed attorneys were practicing in-house.15 by 2000, the amount of licensed, in-house attorneys increased by forty percent.16 in-house attorneys are beginning to do work that was traditionally done by outside counsel.17 according to one survey, about sixty-eight percent of transactions are currently performed in-house.18 moreover, in-house attorneys command greater respect in the legal profession than they once did.19 a key driver behind the surge in number of in-house counsel is that they provide a lower cost alternative to law firm services.20 by moving legal work in-house, a company could avoid large legal fees paid to law firms and avoid duplicative work and miscellaneous expenses.21 however, cost savings is not the only driver behind the increased use of in-house counsel. inside lawyers are in a better position than outside lawyers to “understand the company’s business and to engage in the kind of risk assessment and preventative counseling that managers need to survive in 14 id.; see also david b. wilkins, is the in-house counsel movement going global? a preliminary assessment of the role of internal counsel in emerging economies, 2012 wis. l. rev. 251, 259 (2012). 15 eli wald, in-house myths, 2012 wis. l. rev. 407, 419 (2012) (observing that in-house legal departments do not offer any better shot at gender equality than large law firms) [hereinafter wald, in-house myths]. 16 id. 17 id. 18 jonathan lipson et al., foreword: who's in the house? the changing nature and role of in-house and general counsel, 2012 wis. l. rev. 237, 243 (2012). 19 id. (noting that “[t]oday the [in-house counsel position] attracts well-known partners from elite corporate firms, typically carries a senior title within the corporate hierarchy, and is associated with significant prestige within the legal profession.”). 20 id. at 242. 21 boozang, supra note 13; see also wilkins, supra note 14, at 259. 190 indiana health law review vol. 12:1 an increasingly complex and turbulent legal environment.”22 indeed, a qualitative study of general counsel from the 1990s showed that fifty percent of those sampled saw themselves as “consigliere for senior executives giving advice on matters at the intersection of business and law.”23 surveyed in-house lawyers also saw themselves as entrepreneurs who viewed their legal role as not merely a necessary complement to corporate functions, but as one of a number of ways in which lawyers could further the business interest of the company.24 moreover, in addition to providing effective advice, inside lawyers believe they are able to provide “independent professional judgment” that is essential to a company.25 the traditional corporate law firms are also changing to meet the changing needs of its existing clients and to obtain new clients. instead of training lawyers to be general counsel to corporations, traditional law firms are emphasizing specialization in legal knowledge and fostering niche practice areas in various industries, including health care. this gives rise to different types of large law firms that follow different patterns of growth.26 in the personal service sphere, there is the continued shortage of legal assistance for people without significant resources.27 civil legal assistance for poor and disadvantaged people is provided by legal services offices staffed by federally funded lawyers, law offices staffed by lawyers funded from other sources, and pro bono services provided by programs organized to assist the underserved. in terms of the number of lawyers involved, pro bono is now the largest 22 wilkins, supra note 14, at 259. 23 id. at 261-62. 24 id. at 262. 25 id. at 261. 26 eli wald, smart growth: the large law firm in the twentyfirst century, 80 fordham l. rev. 2867 (2012) [hereinafter wald, smart growth]. 27 see gillian hadfield, the cost of law: promoting access to justice through the corporate practice of law, usc law legal studies paper no. 12-26 (2012), available at http://papers.ssrn.com/ sol3/papers.cfm?abstract_id=2183978, archived at http://perma.cc/u7eb-3zbp. http://dx.doi.org/10.2139/ssrn.2183978 2015 transformations in health law practice 191 component of civil legal assistance.28 partly as a result of the shortage of government funding, there has been the emergence of public/private provision of legal services to the poor and disadvantaged; pro bono attorneys, law students, and non-lawyers can meet these needs.29 this is a period of searching for new ways to provide access to justice. iii. health law workplace sites health care lawyers are caught up in the dual transformations of health care and legal organization as the nature and setting for their practice changes. this paper concentrates on two types of practice: the corporate law sector that serves business and the “access to justice” sector that assists individuals. these practices serve very different clients. these sites might be seen as the far ends of the continuum of legal practice. however, by examining these specific practices, the challenges to health care lawyers caught in the transformation of the nature and setting for their practices is illuminated. the examination of these changes in such different settings highlights how health care lawyers adapt their practices. in the corporate sector, the integration of hospitals and clinics, the incentives for value-based care, and the mandated public reporting on costs and outcomes is changing the relationship between the corporate law firm and its clients. in the access to justice sector, increased emphasis on patient centeredness, integration of acute and public health, and expansion of subsidized coverage makes health law a focus for improving the lives of poor and disadvantaged people. a. outside and inside: in-house counsel and corporate law firms the trend of increasing reliance on in-house counsel can be seen in health care. because health care is a highly 28 rebecca sandefer, lawyers’ pro bono service and americanstyle civil legal assistance, 41 law & soc’y rev. 79 (2007). 29 id. http://dx.doi.org/10.1111/j.1540-5893.2007.00292.x 192 indiana health law review vol. 12:1 regulated industry, and is increasingly so, the need for lawyers pervades.30 although this demand for lawyers includes those who practice in-house as well as in outside law firms,31 the roles of each are shifting to meet the evolving needs of health care organizations. one pronounced shift is the growing role of general counsel inside health care organizations. according to some legal scholars, as discussed earlier in this paper, lawyers on the inside of an entity are better equipped to give advice because they understand the company’s business and therefore know which guidance and news is relevant to the company, and which is not.32 however, the role of the traditional, or “outside” corporate lawyer, is also being revised, particularly in health care. the changes can be summed up as follows: whereas the outside health lawyer once occupied the role of gatekeeper for a health organization’s various legal needs, the growth of in-house counsel in health care organizations has changed the role of the outside health lawyer. this is true with regard to a corporate law firm’s traditional clients, which often include health care systems (both acute and long-term care), practitioners, and health insurance plans. these clients once relied on outside law firms to handle most of the organization’s needs. the firms offered overall knowledge of the health care regulatory landscape and were equipped to handle tax, anti-trust, corporate transactions, employment, and real estate matters. in essence, the outside health lawyer orchestrated general counsel services for the organization. the health sector is increasingly moving the general counsel role in-house for two primary reasons: (1) so that a legal advisor is intimately involved in business operations and strategic planning and (2) due to the exponential growth in regulations leading to rising legal costs. hiring 30 jennifer smith, want a law job? learn the health-care act, wall st. j. (june 16, 2013, 11:40 pm), available at http://online.wsj.com/news/articles/sb1000142412788732404950457854 5460856078702, archived at http://perma.cc/t3bq-5la4. 31 id.; boozang, supra note 13. 32 boozang, supra note 13; see also wilkins, supra note 14. 2015 transformations in health law practice 193 in-house counsel helps health care organizations address regulatory change as part of business strategy and, simultaneously, controls the costs of legal services. despite moving more legal services in-house, health care organizations still rely on outside counsel, albeit for very specific projects. outside health lawyers with highly specialized skills, that in-house offices may need from time to time but cannot staff on a regular basis, are an important component to the health law landscape. furthermore, smaller health care organizations that are unable to afford to hire in-house counsel still need outside health lawyers to guide it through the regulatory land mines that do not discriminate based on an organization’s size. regardless of the organization’s size, health care clients seek to improve their bottom line as well as share a desire to serve patients or enrollees and ultimately improve health, even if such improvement is not the most efficient or cost effective way for society as a whole. the health lawyer may be seen as sympathetic to these dueling goals and, thus, a trusted advisor for health care clients, whether working in-house or in a law firm. the pressing question for health lawyers, whether future, new, or existing, is how they can utilize their skills in-house and in a law firm, especially as health care law continues to evolve. typical health lawyer skills consist of knowledge of the health care regulatory landscape, as well as an understanding of, or at least an appreciation for, the business side of health care. mastering a wide variety of laws such as stark (limitations on physician self-referral of medicare and medicaid patients), anti-kickback, medicare and medicaid reimbursement and conditions of participation, the health insurance portability and accountability act (hipaa), state licensing laws, provider credentialing, employee retirement income security act (erisa), state insurance regulation, and payor contracting principles are staples in health law curricula and practice.33 33 see e.g., fundamentals of health law cle programs, am. health lawyers ass’n (2012), available at https://www.healthlawyers.org/store /pages/product-details.aspx?productid={5a554edf-0235-e411-93b6 194 indiana health law review vol. 12:1 since 2010, many health lawyers are also now expected to know the various provisions of the aca.34 the next two sections examine how health lawyers are applying these skills in-house and in law firms. 1. increasing reliance on in-house counsel health care clients are especially relying on in-house counsel to help navigate the aca’s provisions and strategize about the organization’s future initiatives.35 enforcement delays, along with burgeoning lawsuits challenging various aspects of the law, make it difficult for stakeholders to plan for and implement the aca.36 the level of uncertainty presented by the aca causes companies to bring in-house lawyers into more strategic advising sessions and then to turn to the general counsel for guidance.37 furthermore, inhouse lawyers assist health care organizations in managing increasing consumer expectations.38 unlike the tepid consumer reaction to the roll-out of the hipaa privacy and security regulations, the aca is pushing consumers to be much more savvy and active in their health care and coverage – the commodity sold by health care clients. general counsel have commented that health care consumers are much more sophisticated than in the past and therefore playing a larger role in evaluating health care services and products.39 aca initiatives, such as accountable care organizations (acos) and health 00505692001d}. . 34 id. 35 roundtable discussion, univ. of wis. law school, madison (october 24, 2013) [hereinafter madison roundtable]. 36 see supra note 3. 37 the increasing importance of the in-house counsel appears to be moving from the west of the united states to the east. this is because the integrated health care model started in the west and upper midwest and is just beginning to take hold in the east. as the changes in health care take hold, we can expect to see the growth and shifts in the in-house counsel emerge throughout the country. 38 madison roundtable, supra note 35. 39 id. 2015 transformations in health law practice 195 information exchanges, require greater consumer engagement.40 in addition, the growing trend in transparency to provide health care consumers with greater access to standardized health care quality and cost data, such as that being provided by the wisconsin health information organization,41 will likely lead to provider concerns about liability and marketplace reputation.42 health care organizations will seek legal advice and assistance to traverse potential disputes that arise from performance standardization and enhanced consumer knowledge about the inputs of health care.43 in-house professionals now seek to utilize malpractice claims to locate potential problems within the organization.44 the disputes that derive from disagreements about the use of performance standards and from claims of malpractice are increasingly important. the disputes provide data and information that can be utilized by the in-house counsel to refine the quality and safety systems now required by federal regulation.45 the aca framework has enhanced the need for the skills of the lawyer and the role of the in-house counsel, not only on the business end but also in overseeing the quality dimensions. the move towards value, evidence–based care, 40 id.; see also barbara j. zabawa et al., adopting accountable care through the medicare framework, 42 seton hall l. rev. 1471 (2012). 41 home, wis. health info. org., http://www.wisconsinhealthinfo. org/ (last visited dec. 27, 2014) (the wisconsin health information organization is a voluntary initiative supported by insurance companies, health care providers, major employers, and public agencies that has created “one of the most comprehensive sources of health claims information available anywhere in the united states.”). 42 guy boulton, group seeks medicare data to increase health care efficiency, milwaukee. j. sentinel (jan. 11, 2014), http://www.jsonline.com/business/group-seeks-medicare-data-toincrease-health-care-efficiency-b99181177z1-239783441.html, archived at http://perma.cc/qmh7-9qje. 43 michael d. roth & leonard m. fromer, identifying and resolving disputes in new accountable care settings, am. health lawyers ass’n connections, dec. 2013, at 14-23. 44 joanna c. schwartz, a dose of reality for medical malpractice reform, 88 n.y.u. l. rev. 1224 (2013). 45 id. 196 indiana health law review vol. 12:1 and integration of care makes essential the coordination among audit, safety, compliance and legal counsel sectors within the health care organization. the in-house counsel often serves as the coordinator among staff that works in various areas of corporate compliance, quality and audit. moreover, corporations are seeking lawyers to fill compliance and audit roles once filled by non-lawyers.46 for example, the move toward payment systems tied to high quality and value creates significant potential for legal disputes.47 disputes may arise over shared savings, failure to meet quality benchmarks, or overutilization of high-cost procedures or out-of-network care.48 lawyers who have knowledge about these initiatives as well as the legal system generally can help health care organizations navigate through these potentially expensive and disruptive disputes.49 in addition to using lawyers to perform tasks previously performed by non-lawyers, health care organizations use inhouse counsel for much of the work done previously by outside law firms, such as routine corporate legal paperwork and strategic decision-making in matters such as mergers, acquisitions and larger-scale litigation.50 this is partly due to companies expecting in-house counsel to control spending on outside legal work.51 as a result, inhouse counsels decide what work should be performed inhouse and which firms to use for outsourced work.52 moreover, because hipaa requires “covered entities” such as providers and payers to have a dedicated hipaa privacy officer,53 hipaa compliance, at least in part, must be inhouse. finally, the increasing interest in in-house work relates in part to the gender aspect. balancing work and family is often seen as easier if working as an in-house 46 madison roundtable, supra note 35. 47 roth & fromer, supra note 43. 48 id. 49 id. 50 wald, in-house myths, supra note 15, at 413. 51 lipson, supra note 18, at 242 (noting that controlling spending on outside legal work is a top priority for in-house counsel). 52 id. at 243. 53 45 cfr § 164.530(a)(1) (2014). 2015 transformations in health law practice 197 attorney.54 lawyers may also see that combining social good and economic well-being is easier in the in-house role. 2. defining the roles of the outside health lawyer people do not often associate corporate lawyers as being crucial to improving social goods like health care, but opportunities for such improvement arise in the corporate transactional and regulatory world. it is the corporate lawyer’s role as an advisor, specialist and creative thinker that clients value. the literature suggests that outside health lawyers can provide value to health care clients in two primary ways: through legal opinions independent of solely business interests and through very specialized practice areas.55 the function of the outside lawyer has been shaped in part through increased competition and structural changes in the legal market for corporate legal services.56 increasing numbers of law firms created competition in the market for legal services, causing corporate clients to turn to different law firms to handle various legal needs.57 in addition, rising numbers of in-house legal departments allowed corporate clients to “both handle some of their basic legal and corporate paperwork internally and more effectively manage their overall legal needs, cutting costs and eliminating a significant income source for large law firms.”58 as in-house counsel assumed greater responsibility, the opportunities for outside lawyers to provide regular, general and continuous legal services to 54 better on balance? the corporate counsel work-life report, program on worklife law, am. univ., at 17 (dec. 2003), http://worklifelaw.org/publications/betteronbalance.pdf, archived at http://perma.cc/42ge-texn (last visited dec. 28, 2014). 55 see e.g., robert gordon, the ideal and the actual in the law: fantasies and practices of new york city lawyers, 1870-1910, in the new high priests: lawyers in post-civil war america 51 (gerard w. gawalt ed., 2010); wald, in-house myths, supra note 15; lipson et al., supra note 18. 56 wald, in-house myths, supra note 15, at 414. 57 id. 58 id. 198 indiana health law review vol. 12:1 corporate entities dwindled.59 as a result, outside lawyers were increasingly limited to “ad hoc, high-profile, unique and specialized representations,” under the supervision of in-house counsel.60 it is the ability of the outside lawyer to represent corporate clients, such as health care organizations, in unique, high-profile or specialized matters that creates value for corporate clients. the role of the outside corporate lawyer as an independent voice in a regulatory and political quagmire has early roots in american legal history. as noted by robert w. gordon, who wrote about corporate law practice in the late nineteenth century and early twentieth century, the demand for corporate legal services is at least partially a function of the american political ideologies of liberal individuals and that corporate power must serve the public ends of the common wealth.61 corporate lawyers in the mid-1880s served as legal brokers and intermediaries between large american corporations trying to attract new capital in the process of consolidation or of reorganization after bankruptcy, and the investment banking communities of wall street and europe that supplied most of the capital.62 "[l]awyers invented for themselves liaison roles in building or rebuilding financial structures of american corporations that ensured the prosperity of the largest new york city law firms and came to seem indispensable to their clients."63 thus, outside corporate lawyers may distinguish themselves from in-house counsel by not allowing themselves to "be absorbed by their business clients."64 instead, corporate lawyers exist in independent firms, which allow them to more easily see adverse long-run effects of decisions in the wider social, political, regulatory and business community.65 the outside lawyer can serve as 59 id. at 415. 60 id. 61 gordon, supra note 55. 62 id. 63 id. at 59. 64 id. 65 id. 2015 transformations in health law practice 199 the liaison between corporate management and the greater community. in a more cynical view of the use of outside lawyers, [clients] want lawyers to fend off or neutralize [the community, pro bono benefit] or to invent or lobby for new legal forms that circumvent the restrictions, or, perhaps most important, to find ways of writing the restrictions so as to reassure people that corporate conduct within them is safe and legitimate.66 a legal opinion from an independent, outside lawyer is very valuable in securing reassurance that a particular strategy is permissible. as one general counsel stated recently, in-house counsel go to outside law firms to get a "yes" regarding a plan or strategy desired by management.67 because health care organization management increasingly involves in-house lawyers with strategic planning, in-house counsel seek protection from those strategic decisions by seeking advice and guidance from outside counsel.68 thus, outside corporate law firms are essential in navigating ethical and conflict of interest issues, as well as offering an independent point of view that provides security to various business decisions.69 in addition to an independent legal opinion, recent articles and publications indicate that another use of outside counsel, particularly for health care organizations, involves specialty practice areas that in-house lawyers do not have time to master. "even companies with robust inhouse law departments are increasingly calling on outside lawyers who specialize in the most arcane corners of healthcare law."70 some of those arcane corners of health care law 66 id. 67 madison roundtable, supra note 35. 68 david j. galbenski & david barringer, legal visionaries: how to make their innovations work for you (2013). 69 id. 70 smith, supra note 30. 200 indiana health law review vol. 12:1 include complex hospital mergers, investments in new medical technology, appealing medicare audits, or handling reimbursement disputes.71 other areas in which outside firms are well positioned to help health care clients include "capital markets, private equity, white collar crime and securities enforcement."72 generally speaking, in-house counsel is more likely to outsource, under their supervision and management, representations that are ad hoc, highprofile, unique and specialized.73 the increased need for specialization by health care clients is forcing general health care lawyers to reevaluate their role in the corporate law firm. some outside health lawyers are finding narrower niches in private law practice to thrive and survive. for example, one health lawyer who started out representing small clinics and nursing homes developed a specialty in medicare appeals that earned him a national client base.74 other health care lawyers in private practice may find niche areas in the types of clients they serve, such as alternative health care providers or behavior health specialists, rather than the large health care clients that once were the mainstay of large law firms.75 other general health care lawyers in private practice may find themselves playing the role of client visionary and manager. one in-house general counsel stated recently, “i need lawyers to make important breakthroughs, both large and small.”76 for outside law firms to make those important advances and add value to corporate health care clients, the firm needs collaborative teams of lawyers from different disciplines to strategize about the client’s needs and role for the future. the outside "general" health lawyer may serve as the "glue" for those multidisciplinary teams 71 id. 72 larry ribstein, the death of big law, 2010 wis. l. rev. 749, 775 (2010). 73 wald, in-house myths, supra note 15, at 415; see also lipson et al., supra note 18, at 243 ("corporations typically outsource matters that are large, complex, or specialized."). 74 smith, supra note 30. 75 wald, in-house myths, supra note 15, at 413. 76 galbenski, supra note 68, at 101. 2015 transformations in health law practice 201 and lead those teams, despite having to increasingly rely on lawyers with specialized expertise to fill the void that may exist in the in-house legal department. skilled outside health lawyers will know the direction in which the winds of health industry change are blowing, particularly with regard to forthcoming regulatory changes, and can advise clients accordingly. indeed, in most instances, the regulatory winds blow in the direction of closing monetary loopholes and trying to strengthen the underlying "triple aim" of health care: better health, better care and lower costs. effective corporate health lawyers feed the dueling desires of corporate health care clients with ideas and innovations that strive to provide the best, medically necessary care while generating revenue. for example, as noted earlier, the aca is encouraging merger and consolidation with the growing interest in acos. yet, not all health care practitioners and clients are embracing that trend, while others may feel left out because, for example, the medicare shared savings program only allows certain providers to form a medicare aco (see e.g., 42 cfr 425.102(a)). outside health lawyers can help frame a proud existence for those clients on the fringe of the consolidation trend through legal entities, such as the independent practice associations (ipas),77 that help providers maintain independence while boosting negotiating power in the marketplace. indeed, as more managed, integrated systems continue to move from the west to the east coast across the united states, outside lawyers with specialized knowledge in creating these larger, integrated structures or finding legal alternatives to stay independent will be in high demand.78 77 ipas consist of “a network of physicians who agree to participate in an association to contract with health maintenance organizations (hmos) and other managed care plans. although physicians maintain ownership of their practices and administer their own offices, the ipa serves as a corporate structure for negotiating and administering hmo contracts for its physician members.” k. grumbach et al., independent practice association physician groups in california, 17 health affairs 227, 227 (1998). 78 id. at 227-28 (noting ipas and other physician integrated models are prominent organizational structures in the western states whereas http://dx.doi.org/10.1377/hlthaff.17.3.227 202 indiana health law review vol. 12:1 since the outside health care lawyer is seen as independent from the client, as well as knowledgeable, the lawyer can help advocate and legitimize these legal arrangements and tout his or her effectiveness to not only the client, but the community at large.79 in other words, corporate health lawyers who are intimately familiar with the health care industry are in a position to shape their practice to influence clients and create discursive diffusion around achieving alternative and beneficial ways of providing patient care.80 moreover, the independence of the outside lawyer frees him or her from many of the conflicts of interest that arise in the in-house context and thereby opens up opportunities to work in the community to improve social determinants of health. this community work may be in the form of pro bono representation, such as with medical-legal partnerships (discussed below), board memberships and public representation on committees.81 b. expanding medical-legal partnerships82 one of the sites for practice for improved and patientcentered health care is medical-legal collaborations. the medical-legal partnership (mlp) developed at boston in other regions of america, hmos contract directly with individual physicians); see also boozang, supra note 13. 79 see, e.g., gordon, supra note 55 (“as intermediaries between corporate clients and powerful outsiders – investors, creditors, and stockholders as well as local, national and foreign governments – and as cosmopolitans attuned to popular and foreign public opinion, corporate lawyers were frequently in a position to tell their clients that some proposed action would have adverse [or positive] long-run effects.”). 80 zabawa et al., supra note 40. 81 in-house counsel may also provide community work within the limits of conflicts of interest. 82 some of the materials in this paper on medical-legal partnerships, along with the discussion of lawyers as colleagues with doctors and other professionals, are from an article by paula galowitz, one of the coauthors; that article is paula galowitz, the opportunities and challenges of an interdisciplinary clinic, 18 int’l j. clinical legal educ. 163 (2012). 2015 transformations in health law practice 203 medical center in 1993 was one of the first.83 there are a variety of models for medical-legal collaborations. many, but not all, are listed on the website of the national center for medical-legal partnership (ncmlp).84 according to that website, there are 262 medical-legal partnerships in 36 states, with 135 hospitals, 127 health centers, 35 health schools, 127 legal aid agencies, 46 law schools, and 70 pro bono partners.85 mlps can occur in diverse contexts or be targeted to specific populations, such as children, the elderly, victims of domestic violence, or patients with cancer. typically, mlps have a multidisciplinary,86 holistic and preventive approach to help address the multidimensional problems faced by patients/clients that impact health. legal assistance is integrated into the health care delivery model. the lawyers provide legal advocacy in a medical setting for clients referred by medical professionals. it is a “multidisciplinary model [that] can respond to the myriad needs of those who are poor or marginalized by their social, medical or psychological circumstances.”87 these partnerships can 83 ellen cohen et al., medical-legal partnership: collaborating with lawyers to identify and address health disparities, 25 j. gen. internal med. 136, 138 (2010). 84 the national center, nat’l ctr. for med.-legal p’ship, http://medical-legalpartnership.org/national-center/ (last visited dec. 28, 2014) [hereinafter ncmlp] (the ncmlp was formed in 2006 to guide the expansion of the medical-legal partnership model; in 2013 the national center became a project of what is now called the milken institute school of public health, george washington university). 85 partnerships across the u.s., nat’l ctr. for med.-legal p’ship, http://www.medical-legalpartnership.org/partnerships/ (last visited dec. 28, 2014). 86 the terms “interdisciplinary” and “multidisciplinary” are sometimes used interchangeably but they have different meanings. “multidisciplinary” implies that each discipline approaches issues from its own perspective, staying in its own “silo,” more akin to separate but equal, while “interdisciplinary” implies a more integrated teaming among disciplines. see rebecca l. jessup, interdisciplinary versus multidisciplinary care teams: do we understand the difference, 31 austl. health rev. 330, 331 (2007). 87 stacy l. brustin, legal services provision through multidisciplinary practice—encouraging holistic advocacy while protecting ethical interests, 73 u. colo. l. rev. 787, 792 (2002). http://dx.doi.org/10.1007/s11606-009-1239-7 http://dx.doi.org/10.1071/ah070330 204 indiana health law review vol. 12:1 improve the health and well-being of low-income communities and other vulnerable populations by meeting legal needs of the individuals and helping to alleviate legal barriers to health. many patients and clients have issues in which it can be difficult to separate the legal aspect from that which is typically associated with other disciplines. patients can present with a multitude of psychosocial issues, including family disruption (due to illness, incarceration, violent injury, child abuse and/or neglect), poor housing, unemployment and poverty, domestic violence, lack of access to health care, and immigration problems. some legal-related issues can affect the health of individuals. furthermore, many of the problems that affect the health of children and families have legal remedies. many legalrelated issues can affect the health of the patients, such as asthma triggered by mold from leaky ceilings or rodent infestation; lead poisoning from paint not removed; burns caused by families heating apartments with stoves; and children’s failure to thrive due to lack of sufficient food. many of these partnerships have a three-fold approach: direct legal representation, changes to clinical or institutional policy, and systemic policy changes. the mission of the ncmlp is: to build a healthcare system that deploys the expertise of the country’s existing public and pro bono civil legal aid community to identify, treat and prevent health-harming legal needs as part of basic, quality healthcare at every healthcare institution serving low-income people . . . [t]his transformation is critical to helping the most vulnerable americans get and stay healthy.88 88 2014 medical-legal partnership summit, http://www.cmesam. com/pubcmedetails.aspx?id=7301 (last visited january 5, 2015). 2015 transformations in health law practice 205 the passage of the aca is enabling mlps to enlarge the need for and potentials of medical-legal collaborations.89 the aca has placed population health and prevention as a crucial element in health care, creating incentives for hospitals and health care providers to look outside the walls of the health care institutions to see what can keep patients healthy. lawyers can be part of the team and must be included as the health world moves to interprofessional practice. legal needs of patients that impact health must be included in the broader context of the health world.90 moreover, medical-legal collaborations can serve larger numbers of vulnerable populations in a variety of ways, including through training of health care professionals and innovations in clinical care. one of the critical designs of the aca is the support for community-based care; the act “augment[s] the health care safety net by supporting community health centers, community-based care, and community-health-needs assessments.”91 changes to the internal revenue service (irs) reporting requirements for non-profit hospitals are connected to this element of the act; the hospital must report its community benefits in order to maintain the hospital’s non-profit status.92 in addition, non-profit hospitals have to complete and present a community health 89 see, e.g., joel teitelbaum, obligation and opportunity: medicallegal partnership in the age of health reform, 35 j. legal med. 7 (2014); james teufel et al., rural health systems and legal care: opportunities for initiating and maintaining legal care after the patient protection and affordable care act, 35 j. legal med. 81 (2014); diane m. goffinet et al., medical-legal partnerships in the age of the affordable care act, 47 clearinghouse rev. 265 (2013). 90 “health-harming legal need” has been defined as a “social problem that adversely affects a person’s health or access to health care, and that is better remedied through legal-medical collaboration rather than health care services alone.” joel teitelbaum, the aca and community impacts: the role of medical-legal partnership, nat’l ctr. for med.legal p’ship (april 25, 2013), available at https://uwphi.pophealth.wisc.edu/programs/healthpolicy/ebhpp/events/20130425/teitelbaum.pdf, archived at https://perma.cc/u798-da8u. 91 goffinet, supra note 89, at 267. 92 id. http://dx.doi.org/10.1080/01947648.2014.884429 http://dx.doi.org/10.1080/01947648.2014.884899 206 indiana health law review vol. 12:1 needs assessment in order to be in compliance with nonprofit tax-exempt 501(c)(3) requirements.93 these community benefits include: [p]rograms and services designed to meet community health needs, increase access to health care, and respond to the needs of vulnerable populations. community benefits activities fulfill a health system’s commitment to provide care to those who are unable to pay and those who are members of traditionally vulnerable and underserved groups. community benefits are mission driven, often supplying services or programs with a low or negative profit margin—programs that would likely be discontinued if the decision were solely financially driven. community benefits include uncompensated (charity) care, free and reduced-cost services . . . research, medical education, and other in-kind services.94 these required community needs assessments should encourage medical-legal collaborations since they increase access to health care and respond to the needs of vulnerable populations. moreover, the hospitals can see the mlps as a vehicle for providing the community benefits in a coordinated fashion linked to health outcomes. hospitals can satisfy the community benefits requirement though financial and logistical support for mlps. the aca also aims to reduce health disparities, and medical-legal collaborations are one of the ways to do that. “medical care is only responsible for approximately 10 to 15 percent of what determines health . . . physicians cannot do it all by themselves. they need to work collaboratively with other professional to address the root causes of disease.”95 93 id. 94 id. at 268. 95 interview with david r. williams, professor of public health, harvard school of public health (july 10, 2013) (“a national commitment is needed to eradicate health disparities”). 2015 transformations in health law practice 207 it is well documented that social determinants like housing and income can impact health.96 in addition to the lawyers in the collaborations helping to resolve the legal problems that impact health, the lawyers can help train health care professionals to recognize the legal issues both for the referrals and, in some situations, the health care professionals can help resolve the problems.97 for example, lawyers in a medical-legal collaboration could train the doctor or other health care professional with advocacy tools to challenge the termination of a patient’s utility when the patient’s health is at risk.98 lawyers and health care professionals can also create a standardized order for mold removal in the living conditions of their patients that could be a routine part of the doctor’s protocol, which is completed and submitted by the doctor to the appropriate actors (such as the local agency responsible for enforcement of housing conditions or the owner of the property).99 two other features of the aca highlight the increased need for medical-legal collaborations. one is the emphasis on financing care, which leads to “innovative and integrated methods to change health systems to improve patient and population health”100 such as medical-legal collaborations, which integrate medical and legal care. the other is the focus on promoting population health. examples include penalizing hospitals for readmissions within thirty days of discharge.101 mlps have the 96 ellen m. lawton, integrating healthcare and legal services to optimise health and justice for vulnerable populations: the global opportunity, 2 l. of the future and the future of l., 73 (2012), available at http://www.fichl.org/fileadmin/fichl/documents/lotfs/lotfs_1_web.p df 97 galowitz, supra note 82. 98 goffinet, supra note 89, at 270. 99 telephone interview with ellen lawton, co-principal investigator, nat’l ctr. for med.-legal p’ship (dec. 4, 2013). 100 goffinet, supra note 89, at 271. 101 patient protection and affordable care act, pub. law. no. 111148, § 3025, 124 stat. 119, 408 (2010). 208 indiana health law review vol. 12:1 potential to be part of a strategic plan to develop and implement processes to reduce avoidable emergency department visits and reduce avoidable readmissions. . . . navigating the legal as well as the health care system can help individuals and their families avoid returning unnecessarily to a medical provider for a recurring condition.102 the mlps not only create a framework for providing better health care and outcomes, they can also serve as a linchpin for legal services. a recently created fellowship program designed to build health care expertise in the legal aid community provides training for twenty-four senior level staff in legal aid agencies to deepen their understanding of health care organizations, financing and priorities.103 linking traditional poverty law services to improving health care provides the lawyer with medical colleagues, potential funding and effective client services. it places legal needs in the broad context of the health world. “health justice”104 can also serve as a marketing device for more funding from the health care sector and the corporate sector. mlps are emerging as a dynamic method to deliver legal services to individuals. it links assistance for people with legal needs to health care, a growing sector with public and private funding and delivery. the mlps utilize many of the sectors that deliver legal services for people: legal aid, law school clinics, community centers, and 102 goffinet, supra note 89, at 271. 103 the ncmlp and the national legal aid and defender association (nlada) recently announced new fellowships to build health care expertise in civil legal services. see new fellowship launched to build healthcare expertise among civil legal aid leaders, nlada (march 5, 2014), http://www.nlada100years.org/node/16148, archived at http://perma.cc/rt2l-vkaq [hereinafter nlada]. 104 the medical-legal partnership clinic at loyola university chicago school of law is called the “health justice project.” health justice project, loyola university chicago school of law beazley institute for health law and policy, http://luc.edu/law/centers/healthlaw/hjp/index.html, archived at http://perma.cc/fhj7-c5yz (last visited dec. 28, 2014). 2015 transformations in health law practice 209 pro bono services. while some of the lawyers are practicing pro bono, many of the programs are staffed by legal aid lawyers. the increase and growth in the number of mlps can result in the creation of new jobs.105 in addition to assistance for patients, mlps can be important parts of the health institutions that serve the poor. the federally qualified health centers are important components of service for the poor and disadvantaged and the mlps often provide services for their patients. lawyers can play an integral role as these community based health centers figure out their place in the evolving health care sector.106 iv. learning from the workplaces: reconstructing lawyers’ professionalism identity107 the changing context requires lawyers to adapt at their workplaces. the preceding sections describe how workplaces are adapting and experimenting. each of the sites has distinctive challenges based on the particular way they are interacting with health care patients, providers and institutions. yet, in all three, lawyers are dealing at the workplace with how to reconstruct professional identity.108 these adaptions can be described as creating “bottom-up professionalism,” looking at lawyers’ work from the bottom up, from the perspective of lawyers in a 105 see daniel atkins et al., medical-legal partnership and healthy start: integrating civil legal aid services into public health advocacy, 35 j. legal med. 195, 208 (2014) (“in addition to improving individual and population health and well-being, the mlp model may be a more sustainable method to fund poverty law services due to its value to healthcare partners.”). 106 lawton, supra note 99. 107 we are using “professionalism” to mean "the set of norms, traditions and practices that lawyers have constructed to establish and maintain their identities as professionals and their jurisdiction over legal work.” lawyers’ ideals/lawyers’ practices; transformations in the american legal profession 5 (robert l. nelson et al. eds., 1992). 108 see id. (discussing constructing professionalism at workplace). http://dx.doi.org/10.1080/01947648.2014.885333 210 indiana health law review vol. 12:1 specialized practice, not from the top-down rules.109 one way to look at these adaptations is to place them in three categories: expertise, roles and communities of practice.110 a. expertise the workplace stories demonstrate many changes in the relationship the lawyer has with his or her clients and with health care professionals. the aca encourages health care to move towards collaboration among providers and pay attention to patient engagement. these shifts flatten the traditional hierarchy of relationships. it also encourages more input from various participants that can result in “collaborative intelligence” as the alternative to “professional expertise.” yet when we look at the workplace sites there are examples of lawyer expertise that are valuable in these collaborations and engagement. in this paper, we highlight three areas in which the expertise of the health lawyer is contributing to this recalibrating of relationships in health care. one is that the expertise of the lawyer (and other professionals) is and should be increasingly negotiated with the patient/client,111 which leads to improved health care.112 second, the in-house lawyer’s expertise in navigating disputes is changing the lawyer’s relationship with medical and other types of professionals. third, because of the uncertain regulatory landscape, there is an increased valuation of the lawyer’s 109 lawyers in practice: ethical decision making in context 11 (leslie c. levin and lynn mather eds., 2012). 110 these categories are adapted from the extensive literature that studies the construction of professionalism at the workplace. see philip lewis, aspects of professionalism, in the paradox of professionalism 132-52 (scott cummings ed., 2011). see also lynn mather et al., divorce lawyers at work: varieties of professionalism in practice (2001). 111 this is not a new phenomenon but one that is ever increasing and changing. 112 for a discussion of the importance of doctors and patients participating in mutual sharing of decisions and the barriers to it, see, e.g., a.m. capron, the legacy of jay katz: the abiding relevance of the ‘obligation for conversation’ in the physician-patient relationship, 2 j. health & life sciences l. 1 (2009). 2015 transformations in health law practice 211 expertise by the health care industry in making strategic business decisions. 1. legal expertise for improved patient-centered care a particularly relevant example of how negotiated changes in the lawyer’s expertise affects improved health care is with the issue of informed consent. as noted in a recent article, “significant barriers to effective decisionmaking continue to exist in part due to the medical and legal visions of informed consent as a legal requirement mandating a ritualistic but limited communication between physicians and patients.”113 changes in approaches to informed consent could result in a “more effective patientcentered communication process that invokes shared decision-making among patients, health care providers, family members, and community health workers, all of whom need to be involved in consent for care.”114 to have improved health literacy, which impacts health care dramatically, there need to be changes in the legal rules so there can be shared decision-making. for example, the state of washington has enacted legislation that protects doctors who engage in shared decision-making by creating a legal presumption in favor of the doctor where the patient signed an acknowledgment of shared decision-making; that is prima facie evidence of informed consent that can only be rebutted by clear and convincing evidence.115 changes such as the washington law can help minimize doctor concerns about tort liability for shared decision-making.116 lawyers working within mlps can advocate for laws to facilitate improved patient-centered care. 113 frank mcclellan et al., it takes a village: reforming law to promote health literacy and reduce orthopedic health disparities, 8 j. health & biomedical l. 333, 336 (2013). 114 id. 115 wash. rev. code § 7.70.060 (2015) 116 the possibility of doctor liability is sometimes cited as a barrier to shared decision-making. see mcclellan, supra note 113, at 373. http://dx.doi.org/10.2139/ssrn.2275424 212 indiana health law review vol. 12:1 2. legal expertise to resolve complaints there are similarities at the three sites in the role of the lawyers in the interaction between the lawyer and the medical world. these health law practitioners can bridge gaps in knowledge that health care professionals may have about legal professionals and tear down negative stereotypes. one view health professionals may have of lawyers derives from malpractice actions. some doctors associate lawyers as “ambulance chasers” who sue them in malpractice actions. health lawyers can show doctors and other professionals that the practice of law does not exclusively entail litigation; rather, lawyers provide guidance, create strategies and resolve problems outside the court room. another assumption comes from different views of autonomy of the patient and the client. for most lawyers, the client dictates the result of the relationship. however, for some doctors it is the doctor who advocates as the expert for what the doctor thinks is best for the patient.117 the presence of a lawyer working inside a health care organization can demonstrate alternatives to patient relations. an in-house lawyer’s involvement in mediating disputes between providers and patients is an example of an evolving role of the lawyer as an intermediary between the medical world and the lawyer’s understanding of the utility of disputes. for example, lawyers may use malpractice claims as data for improving care. lawyers can help fashion benchmarks using malpractice data and collaborate with other professionals, such as clinicians and business operations, to help improve an organization’s delivery of health care and thereby reduce patient complaints. as providers move into integrated systems that contain a variety of providers and interests, lawyers can help reconcile differences among those providers to help the integrated system achieve its goals. 117 zabawa et al., supra note 40. 2015 transformations in health law practice 213 3. legal expertise to strengthen business decisions the move toward having the lawyer as part of the business team rather than the autonomous outsider has advantages, especially in the perpetually shifting regulatory landscape since the enactment of the aca. the in-house lawyers have a different set of ethical issues and obligations. these ethical obligations continue to exist despite lawyers working with the business as employees and as part of a multi-disciplinary team. in-house lawyers must preserve their independence and ethical duties while working for the business to develop strategies that are good for the community and bottom line. lawyers who fail to find this balance and gravitate more toward the business goals without sufficient grounding in their role as the company lawyer may be liable for the conduct of the health institution and put themselves at professional risk. nevertheless, it is possible to find the right balance in the business strategy context. for example, in working with a multi-disciplinary team that wishes to take advantage of new federal subsidy programs created through the aca, referenced above, the in-house lawyer can learn about the business reasons for the goal and evaluate those reasons against the backdrop of government regulations. the lawyer is able to use his or her deep knowledge of legal precedent and dispute resolution to find and document answers on which the company can comfortably rely. the corporate law firms who serve as independent interpreters of the law must figure out how to serve as an intermediary between the government regulations and the health care stakeholders. the outside lawyers can play a pivotal role in providing an added layer of reassurance to strategic business decisions that such decisions fall within the legal parameters set by the federal and state governments. 214 indiana health law review vol. 12:1 b. roles: the lawyer as colleague with physicians and other professionals professionals are increasingly aware that working together with other professions can better serve clients and improve outcomes.118 leveraging limited resources can result in improved service for patients/clients, where the professions working together can more effectively address problems than could be done by the professions working separately.119 in addition, there needs to be a “more conscious coordination and integration of delivery of services” to low-income communities.120 according to the ncmlp, preliminary local data indicates the multifaceted impact of these collaborations including improvements in health and well-being; medical homes and institutions; clinical workforce skills; legal services and institutions; and policies, laws and regulations.121 there are benefits for patients and families, benefits for health care staff, and benefits for the community.122 medical-legal collaborations are one of the ways to reduce health disparities. “medical care is only responsible 118 multidisciplinary programs “offer a potentially significant advance in the way legal services are provided to low-income and other marginalized programs.” brustin, supra note 87, at 794. 119 for a discussion of the effective leveraging of limited resources in medical-legal partnerships, see randye retkin et al., medical-legal partnerships: a key strategy for mitigating the negative impacts of the recession, 22 health law 29 (2009). 120 dina schlossberg, an examination of transactional law clinics and interdisciplinary education, 11 wash. u. j.l. & pol’y 195, 210 (2003). 121 ncmlp, supra note 84. 122 see evidence base for medical-legal partnership, ncmlp, http://medical-legalpartnership.org/wpcontent/uploads/2014/03/summary-of-evidence-base-for-medical-legalpartnership.pdf, archived at http://perma.cc/vr3p-dwxt (last visited dec. 28, 2014) (according to the ncmlp, the benefits for patients and families include compliance with health care, treatment of chronic diseases, treatment of asthma and reduction of stress; the benefits for health care staff are improved health care staff knowledge and screening efficacy, and increased health care staff satisfaction; the benefits for the community are the financial savings, public benefits recovery for patients and improved population health). 2015 transformations in health law practice 215 for approximately 10 to 15 percent of what determines health. . . . physicians cannot do it all by themselves. they need to work collaboratively with other professionals to address the root causes of disease.”123 while there are many benefits to the increased collaboration between lawyers and physicians, it is important to acknowledge that there are differences in the professions, which pose challenges for these collaborations to occur and thrive. these differences, which are deepseated and emanate from many sources, include education, training and socialization. there are also differences in the language, customs and norms of the two professions. in addition, the legal and medical professions have their own culture, values and definitions of roles that can impact effective interactions. the variations in role are very broad, including views of role in society and roles in relation to clients/patients. significant sources of the barriers to collaboration between lawyers and health care professionals are the ethical obligations and professional values of the two professions. additionally, the differences in ethical obligations such as confidentiality, conflicts of interest, responsibilities to the client/patient, and the independence of the professional must be addressed. as to the different professional ethics, there are different definitions in a variety of areas, including who is the “client,” confidentiality, conflicts and capacity of the person to make decisions.124 123 david r. williams, a national commitment is needed to eradicate health disparities, robert wood johnson foundation (july 10, 2013), http://www.rwjf.org/en/about-rwjf/newsroom/newsroomcontent/2013/07/a-national-commitment-is-needed-to-eradicate-healthdisparities.html, archived at http://perma.cc/pa3a-9k5u. 124 some literature has discussed some of the ethical issues and professional conflicts in medical-legal collaborations. see, e.g., marcia m. boumil et al., multidisciplinary representation of patients: the potential for ethical issues and professional duty conflicts in the medical-legal partnership model, 13 j. health care l. & pol’y 107, 123 (2010); j. michael norwood & alan paterson, problem-solving in a multi-disciplinary environment? must ethics get in the way of holistic services?, 9 clinical l. rev. 337, 357 (2002); jacqueline st. joan, building bridges, building walls: collaboration between 216 indiana health law review vol. 12:1 the changing roles of the professions highlight the need for multi-disciplinary advocacy. while there has been considerable opposition in the organized bar to lawyers working with other professions, that opposition has primarily been in the private sector between lawyers and financial persons.125 commentators have discussed the different reasons for multidisciplinary practice in public interest practice,126 yet there continues to be resistance to multidisciplinary practice. the changes in health law practice provide another reason to revisit the ethical bans on multidisciplinary practice. a key component of overcoming challenges is for the members of the interaction to have transparent and agreedupon goals and values for the collaboration. there should be a structure that formalizes the relationship and anticipates the possible problem areas.127 moreover, the collaboration needs to use and rely on the knowledge of all of the disciplines and be part of a comprehensive approach to meet the needs of the patients/clients. an additional component is a commitment to the importance of developing creative approaches to assist patients/clients. one important way to improve the methods and outcomes of professional collaboration is to spend sufficient time with the other professionals in planning the professional interaction at the worksite. many of the challenges can be anticipated and addressed beforehand. while dealing with them can be challenging, they are not lawyers and social workers in a domestic violence clinic and issues of client confidentiality, 7 clinical l. rev. 403 (2001). 125 commission on multidisciplinary practice, american bar association, http://www.americanbar.org/groups/professional_responsibility/commiss ion_multidisciplinary_practice.html, archived at http://perma.cc/3p839yxv (last visited dec. 28, 2014). 126 see, e.g., brustin supra note 87. 127 see norwood & paterson, supra note 124 (as stated by the authors in their description of a multidisciplinary practice in which the university of new mexico child advocacy clinic is the legal services provider, the professionals need to work out “an organizational structure that formalizes their relationship and addresses the complexities of responding to ongoing client needs in a manner that both maximizes efficiency of effort and minimizes ethical pitfalls.”). 2015 transformations in health law practice 217 barriers, particularly if the anticipated issues are discussed and addressed amongst the various professionals in the collaboration.128 guidelines and protocols for the anticipated ethical issues (such as what information received from the client can be shared with the other professionals) should be drafted together as part of the development of the collaboration. doctors and lawyers can learn from each other and appreciate the differing professional cultures and skills as well as the problem-solving approaches of the other profession.129 part of that includes learning to understand each other’s language, ethics, professional values, and approaches to our clients/patients. as a result of the interaction, the professionals can learn about the roles, boundaries and limits of each member of the collaboration, as well as gain familiarity with the knowledge base of the other profession. this broadening of perspective can lead to what is described as a higher level of cognitive processing, what some psychologists define as “wisdom.”130 this interaction between the professions can allow for a “window” in which each profession can reconsider their own professional roles and help each of the professions form (and change) their own views of their profession and their roles in it. this “window” may lead to changes in the professional norms of each. for example, lawyers may need to have more flexible work schedules to allow for clients that need 128 see paula galowitz et al., ethical issues in medical-legal partnership in poverty, health and law: readings and cases for medical-legal partnership 157-80 (elizabeth tobin et al., eds. 2011). 129 see boumil et al., supra note 124, at 123. (“with these diverse cultures and problem-solving approaches, collaboration between these professionals [lawyer, doctor, social worker and other professionals in a medical-legal collaboration] results in a formidable team that provides holistic interventions.”). 130 see anita weinberg & carol harding, interdisciplinary teaching and collaboration in higher education: a concept whose time has come, 14 wash. u. j.l. & pol’y 15, 23 (2004) (“it is this higher level of cognitive processing—what some psychologists define as ‘wisdom’—that we see as the ultimate outcome of interdisciplinary higher education.”). 218 indiana health law review vol. 12:1 immediate legal assistance outside of the typical work hours.131 another value of the collaboration amongst professions is that the interaction can also increase satisfaction; the collaboration can be a more satisfying and fulfilling professional and personal experience for all. it can also result in increased comfort in being able to learn from and rely on the other professionals. patients/clients also benefit from interactions by offering more creative and better service for the clients.132 it can result in the professionals being engaged in more creative problem-solving to promote access to justice and health services. the collaboration empowers the professionals to serve their clients/patients in new and better ways. c. communities of practice for lawyers changing their ways of practice, groups of like-minded people can support lawyers’ views of how to behave. these communities can support the lawyers when they create or join workplaces that deviate from the traditional law firm model. typically, lawyers don’t collaborate with other professions, while some of these communities of practice do. the new ways of practice also raise issues of ethical compliance. the workplaces are locations for figuring out how to effectively serve clients in the context of the rules of professional conduct. this can be seen as dealing “bottom-up” with ethical dilemmas.133 131 see lynn hallarman & denise snow, the medical-legal partnership: an alliance between doctors and lawyers in the care of patient-clients with advanced life-limiting illness, 17 n.y. st. bar ass’n health l. j. 1 (2012) (noting that lawyers working in a medicallegal collaboration may need to be available for seriously ill patients at atypical hours). 132 see brustin, supra note 87, at 794 (“an interdisciplinary model also has the potential to encourage lawyers to create innovative programs that not only respond to the perceived needs of client communities but also actively involve clients in bringing about social change.”). 133 see sung hui kim, the ethics of in-house practice, (ucla school of law, law-econ research paper no. 11-12, 2011) available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1919276, archived 2015 transformations in health law practice 219 communities can support lawyers in the creation of an alternative identity and “shape the norms of practice.”134 mlps and in-house counsel have networks of colleagues and local and national associations that provide this support. the mlps have a national partnership that hosts conferences, provides networking for local programs, initiates fundraising, supports legislation to improve their funding, and encourages effectiveness research.135 the ncmlp is instrumental for the dissemination of the model of closely linked legal/medical provision of services to improve health care outcomes. in addition to the ncmlp, there are other support communities in medical-legal collaborations. for example, in new york there is the new york state coalition of medical-legal partnership, which has held conferences, coordinated funding and advocated for the successful passage of the health-related legal services program in the new york state legislature.136 in-house counsels have associations that have been leading the effort for a while to raise the status and position of in-house lawyers. one example is the association of corporate counsel; this group is active in advocating on public issues such as regulating the profession and legal education training.137 the association of corporate counsel hosts educational programs on matters of special interest to in-house counsel, such as lawyer-client privilege and ethical issues facing in-house lawyers.138 both in-house and outside health lawyers benefit from other communities of practice, such as the american health at http://perma.cc/e4xr-2r9d; scott cummings, the accountability problem in public interest practice: old paradigms and new directions, in lawyers in practice: ethical decision making in context 340-64 (lynn mather & leslie levin eds., 2012) 134 mather et al., supra note 110. 135 see ncmlp, supra note 84. 136 n.y. public health law § 22 (mckinney 2012) 137 wilkins, supra note 14. 138 see, e.g., beverly jones & peter tomlinson, presentation for acc america, greater new york chapter, privilege and ethical issues for in-house counsel 2013 (apr. 17, 2013), available at http://www.acc.com/chapters/gny/upload/pbwt-ethics_privilegecle_april-17-2013-2.pdf. 220 indiana health law review vol. 12:1 lawyers association, which hold in-person meetings on a variety of health law topics including medicare and medicaid reimbursement, tax, health information privacy and security, and a special program for in-house counsel.139 collaborative organizations that were born out of the health insurance portability and accountability act (hipaa) privacy and security regulations helps both inhouse and outside lawyers navigate these sticky health law issues. for example, the hipaa collaborative of wisconsin held a roundtable for hipaa privacy professionals to discuss best practices in handling a variety of health information privacy matters.140 these communities of practice mitigate feelings of isolation or frustration that accompany a changing or challenging practice landscape. v. training for practice the health workplace sites demonstrate the need for lawyers today to have competence in new areas in addition to the traditional learning of legal rules and regulations. these lawyers need to master the ability to work in multiprofessional collaborations, have a broad knowledge of substantive areas, understand the complexity of legal roles, and deal with ethical concerns. health lawyers are developing these skills and going beyond the traditional forms of knowledge. while practicing lawyers are coping with these new demands, the law schools lag behind. change has been very rapid and law schools have generally not responded to all the transformations in law and practice. 139 see, e.g., past programs, ahla, http://www.healthlawyers.org/ events/programs/pages/past.aspx, archived at http://perma.cc/9fgwje49; see also wald, in-house myths, supra note 15, at 436 (noting that there is a proliferation of bar associations offering a venue for interacting with lawyers who practice in the same fields of law, or hail from the same or similar backgrounds). 140 see, e.g., dan weissburg, presentation at the hipaa cow 2014 spring conference: pragmatic privacy professionals collaborative roundtable: hearing the heard (apr. 11, 2014) (brochure available at: http://hipaacow.org/event/2014-spring-conference/, archived at http://perma.cc/e733-5hsr). 2015 transformations in health law practice 221 some law schools have specialized programs in health law.141 these programs offer courses on substantive areas of health law, and may offer certificate programs and masters of law in health.142 there are joint degree programs with public health and medical schools.143 a few law schools provide clinics and externships where students are placed in medical and health care settings.144 there are fewer opportunities for collaborative business, health care and law training; law school health law programs for example often do not emphasize business skills.145 it is in the law school that the ethical issues arising from these changing ways of practice can be addressed. the required professional responsibility course can discuss the variety of issues that arise in multidisciplinary collaborations, such as mlps.146 similarly, the complicated ethical issues for in-house counsel and corporate counsel in health law practices, previously discussed in this paper, can and should be incorporated into existing professional responsibility courses. however, the slowness of the law school responses to the transformation leaves the law students lacking information about the health law field and opportunities to develop the new skills it demands. while health law teachers and programs are trying to 141 see formal jd/mph degree programs, supra note 1; health law programs, supra note 1; health law section, supra note 1. 142 id. 143 id. joint degrees can be affordable by using expedited programs and providing placements that provide access to job opportunities. 144 see ncmlp, supra note 84 (the ncmlp website has a listing of law schools with some form of a mlp clinic); see paula galowitz, the opportunities and challenges of an interdisciplinary clinic, 18 int’l j. clinical legal educ. 163 (2012) (discussing the medical-legal advocacy clinic at new york university school of law). 145 see carl j.circo, an educational partnership model for establishing, structuring, and implementing a successful corporate counsel externship, 17 clinical l. rev. 99 (2010) (the article on careers in corporate practice studying the relationship between in-house practice and corporate law firms emphasized that law students need to complement their legal skills with business skills such as strategy, budgeting, value marketing, and leadership). 146 paula galowitz et al., ethical issues in medical-legal partnership, in poverty, health and law: readings and cases for medical legal partnerships (elizabeth tobin tyler et al. eds., 2011). 222 indiana health law review vol. 12:1 accommodate these needs, more must be done by individual teachers and law school programs. one approach is to look to the movement within universities to develop interprofessional education (ipe) as training for the increasingly collaborative health workplaces.147 this is a growing area where “students from two or more professions learn about, from and with each other to enable effective collaboration and improve health outcomes.”148 these ipes can take many forms and directions. in the health care field, the professions engaged in these trainings are primarily medicine, nursing and social work. on-site practice experience and formal education can be linked by providing opportunities to share knowledge both ways. one example is externships where students are in practice sites and participate in a seminar where health care issues are discussed and analyzed.149 in some locations, students from health professions are trained alongside law students. some of these are clinics linked with the mlp network and provide live client experience to learn about collaboration and ethical issues. on the other side, communities of practice such as mlps and corporate counsel groups can join with university ipe programs to discuss ethical dilemmas and collaboration barriers. law schools can take the lead in expanding the range of opportunities, offering more skill-based options, clinics, externships, and information about the changing health care law job market. as mlp clinics continue to be developed in law schools, they can link with ipes and bring legal knowledge to the other professions and vice-versa.150 the shared knowledge 147 see emily benfer, educating the next generation of health leaders: medical-legal partnership and interprofessional graduate education, 35 j. legal med. 113 (2014). 148 id. 149 see e.g., courses by title, skills for health law practice, seton hall law, http://law.shu.edu/students/academics/coursesbytitle.cfm (last visited dec. 28, 2014). 150 benfer, supra note 147; see also robert pettignano et al., the health law partnership: a medical-legal partnership strategically designed to provide a coordinated approach to public health legal http://dx.doi.org/10.1080/01947648.2014.884910 http://dx.doi.org/10.1080/01947648.2014.884892 2015 transformations in health law practice 223 and interaction can provide the skills training with supervision. moreover, it can lead to crosstraining for the faculty teaching the programs. a recent initiative is providing ten faculty fellowships to promote public health law education to “build a learning community among those who teach public health law at professional and graduate schools.”151 the academic training can also be linked with the experiences at the workplaces. for example, guidelines and protocols to aid cross-professional practice are being developed and disseminated at the workplace sites.152 the mlps are an example of how communities of practice develop networks to train and learn together.153 on-site practice experience and formal education can be linked by providing opportunities to share knowledge both ways. one example is externships where students are in practice sites and participate in a seminar where health care issues are discussed and analyzed.154 in some locations, students from health professions are trained alongside law students. on the other side, communities of practice such as mlps and corporate counsel groups can join with university ipe programs to discuss ethical dilemmas and collaboration barriers. in addition to the shared educational opportunities, interprofessional collaborations can lead to the development of proposed protocols and potential legislation.155 ipes can also lead to continued learning post law-school. programs are now available for mutual learning even after law school services, education, advocacy, evaluation, research, and scholarship, 35 j. legal med 57 (2014). 151 ten faculty fellowships awarded to promote public health law education, georgia state center for law, health & society (mar. 4, 2014), http://clhs.law.gsu.edu/2014/03/04/ten-faculty-fellowshipsawarded-promote-public-health-law-education/, archived at http://perma.cc/z5jw-96dk (program funded by the robert wood johnson foundation). 152 see earlier discussion in section (iii)(b). 153 35 journal of legal medicine (2014), available at http://www.tandfonline.com/toc/ulgm20/35/1#.u1mssvldwuj, archived at (a recent edition of the journal of legal medicine devoted an entire edition to eleven articles about mlps). 154 see e.g., courses by title, supra note 149. 155 benfer, supra note 147. 224 indiana health law review vol. 12:1 graduation. for example, cuny school of law many years ago initiated a successful community legal resource network (clrn) where solo practitioners, including health law practitioners, meet together and mentor each other in the law school community.156 similarly, opportunities to link health care expertise with business practices can develop through shared programs with business schools and technology departments.157 these communities can build on shared knowledge to influence policy and practice protocols to implement new laws.158 one example is the hipaa collaboratives that developed after the passage of the act. these state–based networks of private practice lawyers, community advocates, and corporate privacy compliance officers worked together to create documents and procedures to enable implementation of the complex federal statute.159 ethical concerns were also shared and discussed. an extensive textbook on readings and cases for mlps includes a chapter on ethical issues in mlps.160 the association of corporate counsel provides extensive training on ethical issues within its organization to allow the development of interpretations of ethics codes that are adapted to their workplaces.161 this might be called “bottom-up professionalism.” these three training arenas, when integrated, provide advantages for students in addition to learning. they offer both access to networks and experience at workplaces that prove valuable opportunities for employment after 156 community legal resource network, cuny school of law, http://www.law.cuny.edu/clrn.html, archived at http://perma.cc/7txeyf53 (last visited dec. 28, 2014) (discussing information about the clrn program). 157 well-known examples are the joint md/mba and jd/mba degrees. see association of md/mba programs, http://mdmbaprograms.com/5.html, archived at http://perma.cc/x2tcha3f (last visited dec. 28, 2014). 158 the privacy collaboratives developed during the hipaa period are one example. see wendy netter epstein, bottoms up: a toast to the success of health care collaboratives…what can we learn?, 56 admin. l. rev. 739 (2004). 159 id. 160 see supra note 149. 161 see jones & tomlinson supra note 138. 2015 transformations in health law practice 225 graduation.162 networks provide an accessible location to link with others in the field. workplace experience allows students to understand the field and locate mentors. particularly in a time when the job market is more difficult to penetrate, the investment in well-thought out academic programs that provide learning, networks and field experience will be well worth the educational investment.163 vi. conclusion growth in health law practice is shaped and encouraged by the current context of health care and legal careers. the intersection is providing opportunities for rewarding work both in the corporate and personal sectors. there are also challenges as the jobs are reshaped. health law practice provides a template for the new lawyer. the ongoing restructuring of the sites for practice and the ways to practice demonstrates that rewarding work continues to be possible in law. perhaps examination of other areas might reveal similar opportunities. the role of law in complex changing fields is no longer primarily to provide only predictability but rather to assist flexibility, orchestration, problem-solving and social justice. this is also an opportune time to reconsider training. legal education is engaged in a massive re-envisioning partly due to the perceived imbalance in the supply and demand for lawyers. law schools across the country “grapple with fewer applicants and fewer jobs for graduates.”164 paying attention to changing ways of practicing health law and looking to interprofessional 162 lynn wood & justin osofsky, crossing the charles: the experiences, networks and career paths of harvard jd/mba alumni, (aug. 2005) available at http://papers.ssrn.com/sol3/ papers.cfm?abstract_id=812425, archived at http://perma.cc/sp7k-g49d. 163 see karen sloan, legal jobs picture: ‘we’re not going back to 2006’, nat’l l. j. (apr. 10, 2014). 164 ariel kaminer, pace picks ex-taxi chief as its law school dean, n.y. times, feb. 27, 2014, at a25, available at http://www.nytimes.com/2014/02/27/nyregion/pace-law-school-picksyassky-ex-taxi-official-as-dean.html?_r=0, archived at http://perma.cc/458t-z2st. 226 indiana health law review vol. 12:1 education can provide law schools with insights into how to better train their students. a market for human organs: an ethical solution to the organ shortage adam crepelle i. introduction ................................................................. 18 ii. the organ shortage ................................................... 20 iii. possible solutions .................................................... 24 a. technology ................................................................... 25 b. presumed consent ...................................................... 28 c. prevention ................................................................... 30 d. facilitate living donation .......................................... 32 iv. organ market ethical issues ................................... 34 v. money for organs ....................................................... 51 a. black market ............................................................... 52 b. iranian kidney system ............................................... 57 vi. analysis and critique of iran's kidney system ...... 63 vii. an organ market in the united states .................. 69 a. live organ market ...................................................... 69 b. cadaver organ market ............................................... 76 viii. consequences of organ market............................ 77 ix. conclusion ................................................................. 79 * master of public policy, pepperdine university school of public policy 2015. juris doctorate, southern university law center, 2013. bachelor of science in exercise science, university of louisiana at lafayette, 2009. i would like to extend my sincerest thanks to dr. robert kaufman of pepperdine university school of public policy and dr. sigrid fry-revere of the center for ethical solutions. dr. kaufman advised me throughout the writing process. his objective commentary on a thesis that he does not agree with is an example all intellectuals should aspire to. dr. fry-revere's courageous research helped inspire my interest in bioethics. she was also kind enough to comment on my paper. http://dx.doi.org/10.18060/3911.0012 18 indiana health law review vol. 13:1 abstract over 120,000 people are waiting for an organ transplant. twenty-one americans die each day waiting for an organ. this problem is not unique to the united states. although technological advancements will likely end the organ shortage one day, technological solutions to the shortage are likely decades away. an organ market is the only solution currently available to the organ shortage. the human organ market is almost universally condemned for ethical reasons. however, the ethical objections to a market do not withstand scrutiny. only one nation allows individuals to sell their kidneys, and this is the only nation to eliminate its kidney waiting list. moreover, the poor and middle classes have greater access to kidneys in this nation than any other country. this nation is iran. the united states should recognize the success of iran's kidney system and implement an organ market. creating an organ market in the united states only requires a few changes to the current organ procurement system. most importantly, a market will improve health outcomes for those in need of organs and likely reduce healthcare costs as well. i. introduction in the united states, over 30,000 organ transplants were performed in 2015.1 although this is a remarkable number of lives saved, the waiting list for organ transplants is over 120,000 candidates long,2 and the list keeps growing. a name 1 organ procurement and transplantation network, u.s. dep’t. health & human serv., https://optn.transplant.hrsa.gov/news/morethan-30-000-transplants-performed-annually-for-first-time-in-unitedstates/ [https://perma.cc/wha4-3cmn] (last visited jan. 29, 2016]. 2 united network for organ sharing, http://www.unos.org/ [http://perma.cc/375f-ljn3] (last visited nov. 5, 2015). 2016 19 a market for human organs: an ethical solution to the organ shortage is added every twelve minutes.3 consequently, a shortage of organs exists. this shortage results in the death of twentyone americans each day,4 and this figure does not include the number of people who die without being placed in the organ queue.5 since 1980, more americans have died waiting for an organ than in all of the nation's wars combined.6 the dearth of organs is not just an american problem. the world average is four transplantable organs available for every 100 people in need.7 in an attempt to procure an organ, some individuals seek directed donations from living donors. many turn to family and friends. if this option fails, people have solicited strangers to part with their organs using newspaper advertisements, billboards, and websites like jimneedsakidney.com.8 directed donation enables the wouldbe organ recipient to bypass the organ waitlist. however, many are unable to procure an organ through this method. this causes an unknown number of people to turn to the black market in a desperate attempt to save their lives. one nation has solved its kidney shortage. since the dawn of the twenty-first century, the country has not had a 3 facts and myths, am. transplant found., http:// www.americantransplantfoundation.org/ab-transplant/facts-and-myths/ [http://perma.cc/j8te-qc76] (last visited nov. 30, 2015]. 4 id. 5 peter aziz, establishing a free market in human organs: economic reasoning and the perfectly competitive model, 31 univ. la verne l. rev. 67, 77 (2009) (“this number does not take into account all the people who have died without being placed on the waiting list.”). 6 sigrid fry-revere & david donadio, america's organ transplant law is criminally unfair to donors, new republic (oct. 23, 2014), http://www.newrepublic.com/article/119963/us-organ-transplant-lawneeds-reform-let-donors-get-reimbursed [http://perma.cc/6y3y-qxgm]. 7 sigrid fry-revere, what can iran teach us about the kidney shortage?, (tedmed broadcast 2015), available at http://tedmed.com/ talks/show?id=309108 [http://perma.cc/ez7z-8ycu]. 8 eric horng & andrew fies, ads, billboard plead for organ donations, abc news (july 24, 2005), http://abcnews.go.com/wnt/ health/story?id=982806 [http://perma.cc/lmh4-e3fx]. 20 indiana health law review vol. 13:1 waiting list for kidneys.9 technology plays little role in the country's ability to provide organs. in fact, the nation has a small healthcare budget and lacks medical equipment.10 the country is poor and often regarded as backwards. nevertheless, by compensating kidney providers, the country has solved a problem that continues to plague the world. the country is iran. this paper will provide an overview of the organ shortage and consider various solutions to it. arguments for and against the market for human organs will be examined. an analysis of organ procurement on the black market and in iran follows, as they are the only systems currently in operation where organs are exchanged for money. a market for organs in the united states is proposed and the market's probable consequences are considered. a conclusion follows. ii. the organ shortage the organ shortage is a result of medical advancements. the first organ transplant was performed in 1954, and potent anti-rejection drugs were approved in 1983, which greatly expanded the opportunity for successful transplants.11 congress passed the national organ transplant act in 1984 (“nota”) creating a task force to examine “the medical, legal, ethical, economic, and social issues presented by human organ procurement and transplantation.”12 this task force 9 ahad j. ghods & shekoufeh savaj, iranian model of paid and regulated living-unrelated kidney donation, 1 clinical j. am s. nephrology 1136, 1137 (2006) (stating iran's renal transplant waiting list was eliminated in 1999). 10 see ahad j. ghods, renal transplantation in iran, 17 nephrology dialysis transplantation 222, 226 (2002) (discussing why renal transplant survival rates may be lower than survival rates in other countries). 11 organ transplant history, live on ny, http:// www.donatelifeny.org/all-about-transplantation/organ-transplanthistory/ [http://perma.cc/9vnd-yjdy] (last visited nov. 30, 2015]. 12 national organ transplant act [nota], pub. l. no. 98-507, § 101(b)(1)(a), 98 stat. 2339 (1984). http://dx.doi.org/10.2215/cjn.00700206 http://dx.doi.org/10.1093/ndt/17.2.222 2016 21 a market for human organs: an ethical solution to the organ shortage reflects congress’ concern that the poor would feel pressured to exchange their organs for monetary gain.13 accordingly, congress prohibited the interstate transfer of human organs for profit while permitting organ donations.14 although the sale of organs is prohibited, people are allowed to donate their organs. nota created the organ procurement and transplantation network (“optn”) to facilitate organ donation.15 the optn created a list of individuals in need of organs, criteria for donor-recipient pairing, as well as guidelines for organ acquisition and transportation.16 nota requires the optn's functions to be carried out by “a private nonprofit entity.”17 the united network for organ sharing (“unos”) received the initial contract in 1986 and has been the optn's contractor ever since.18 in an effort to increase the supply of organs, the united states department of health and human services (“hhs”) has posted materials on its website to help colleges and hospitals promote organ donation.19 additionally, hhs promotes several national events to encourage organ donation, such as national donor day (february 14th) and the national donor recognition ceremony & workshop.20 13 gwen mayes, buying and selling organs for transplantation in the us: national organ transplant act of 1984 (nota) bans buying and selling, medscape, http://www.medscape.org/viewarticle/465200_2 (last visited nov. 6, 2015). 14 42 u.s.c. § 274e(a) (2015). 15 42 u.s.c. § 274 (2015), available at http://history.nih.gov/research/ downloads/pl98-507.pdf [http://perma.cc/2jjy-uvsn]. 16 nota, pub. l. no. 98-507, § 372(b)(2)(a)(d), 98 stat. 2344 (1984). 17 42 u.s.c. § 274(b)(1)(a) (2015). 18 history & nota, u.s. dep’t. of health and human serv., http://optn.transplant.hrsa.gov/governance/about-the-optn/history-nota/ [http://perma.cc/e28d-f2mf] (last visited nov. 6, 2015). 19 campus partner support materials, organdonor.gov http:// www.organdonor.gov/materialsresources/materialscampussupport.html [http://perma.cc/8y9n-5hu8] (last visited nov. 6, 2015). 20 national events, orgondonor.gov, http://www.organdonor.gov/ materialsresources/materialsntlevents.html [http://perma.cc/gc5gbeql] (last visited nov. 6, 2015). 22 indiana health law review vol. 13:1 the donations sought are secured by having individuals consent to become donors at death. this occurs by agreeing to become a donor when renewing one's driver's license or through a state online registry.21 organs from living donors are also welcomed.22 cadavers are the source of kidneys in about two-thirds of kidney transplants; 23 however, kidneys are the most commonly transplanted organ from live donors.24 live kidney donations are common for two reasons. one is that kidneys are the most demanded organ: over 80% of 121,588 people in need of an organ are seeking a kidney.25 the second reason for the high rate of live kidney donation relative to other organs is that most people have two kidneys, but only need one.26 this makes removing kidneys a fairly simple procedure and involves few postoperative health risks. the university of maryland medical center states, “[c]urrent research indicates that kidney donation does not change life 21 organ donation: the process, organdonor.gov, http:// www.organdonor.gov/about/organdonationprocess.html#process1 [http:// perma.cc/9ptm-e9lg] (last visited nov. 6, 2015). 22 living donation information you need to know, united network for organ sharing (2015), available at http://www.unos.org/ docs/living_donation.pdf [http://perma.cc/8zph-ewkc]. 23 organ donation and transplantation statistics, nat’l kidney found., https://www.kidney.org/news/newsroom/factsheets/organdonation-and-transplantation-stats [http://perma.cc/g3bl-l5lh] (last visited nov. 30, 2015). 24 frequently asked questions about living donation, unos transplant living, http://www.transplantliving.org/living-donation/ facts/frequently-asked-questions/#ld [http://perma.cc/96eu-jx2z] (last visited nov. 6, 2015). 25 data, organ procurement and transplantation network, u.s. dep’t. health & human serv., https://optn.transplant.hrsa.gov/ converge/data/ [https://perma.cc/et4c-uada] (last visited jan. 29, 2016) (follow “national data”; “select report,” then “choose category”, “waiting list”; “candidates”; “step 2”, overall by organ”). 26 living with one kidney, nat’l kidney found., https:// www.kidney.org/atoz/content/onekidney [http://perma.cc/q3kv-rvbk] (last visited nov. 30, 2015). 2016 23 a market for human organs: an ethical solution to the organ shortage expectancy or increase a person’s risks of developing kidney disease or other health problems.”27 livers are the organ with the second highest demand,28 and live liver donations can also be made.29 nevertheless, donating a liver is much more troublesome than donating a kidney. people only have one liver; thus, the donor's liver must be split by the surgeon to provide for the recipient. accordingly, approximately one in 300 liver donors die from surgical complications and 30 percent suffer complications.30 for this reason only about four percent of the liver transplants performed in 2014 used live donors.31 likewise, living heart, lung, and other organ donations are extremely rare, so cadavers are the primary source for these organs.32 the dearth of organs has resulted in the use of low quality organs.33 in fact, the organs of cancer patients have been 27 frequently asked questions, univ. maryland med. ctr., http://umm.edu/programs/transplant/services/kidney/livingdonor/faq#q6 [http://perma.cc/9rjl-3pns] (last visited nov. 6, 2015). 28 data, supra note 25. 29 about living donation, am. transplant found., http:// www.americantransplantfoundation.org/about-transplant/livingdonation/about-living-donation/ [http://perma.cc/f47s-lcdp] (last visited nov 6, 2015). 30 q and a on living donor liver transplantation, univ. maryland med. ctr., http://umm.edu/programs/transplant/services/liver/livingdonor/q-and-a-on-living-donor-liver-transplantation [http://perma.cc/ wv8v-8u6b] (last visited nov. 30, 2015). 31 data, supra note 25. (to find current numbers, follow “national data”, “select report, choose category, transplant”, “choose organ, liver”, “transplants by donor type.”). 32 id. (to find current numbers, follow “national data”, “select report, choose category, transplant”, “choose organ, all”, “transplants by donor type”, “change report, heart, lung, intestine, and pancreas.”). 33 jon diesel, do economists reach a conclusion on organ liberalization?, 7 j. am. inst. econ. res. 320, 322 (sept. 2010) (discussing how the growth of the organ waiting list has resulted in “expanded criteria” for procuring cadaver organs), available at http://econjwatch.org/articles/do-economists-reach-a-conclusion-onorgan-liberalization [http://perma.cc/4yk8-xxvv]. 24 indiana health law review vol. 13:1 used in transplants.34 the recipients of these organs have, in some rare cases, developed cancer as a consequence of receiving the organs.35 another problem caused by the shortage is poor quality genetic matches between the organ and the recipient. a better match, unsurprisingly, decreases the likelihood of the recipient's body rejecting the new organ.36 the organ shortage means people have to linger in the organ queue for an average of three to five years.37 the patient's health is deteriorating during this time and may render a patient ineligible for an organ.38 therefore, an organ alternative or a way to increase the supply of human organs is needed. iii. possible solutions outside of a market for human organs, a few solutions exist to alleviate the organ shortage. technological advances will help alleviate the organ shortage one day. preventative healthcare is another way to reduce the organ shortage. presumed consent is a policy successfully used by some countries to increase the organ supply. addition–ally, donor 34 can i donate my organs if i've had cancer, am. cancer soc’y, http://www.cancer.org/treatment/survivorshipduringandaftertreatment/ can-i-donate-my-organs [http://perma.cc/v7hx-x7ge] (last visited nov. 6, 2015). 35 id. 36 christoph frohn et al., the effect of hla-c matching on acute renal transplant rejection, 16 nephrology dialysis transplantation 355, 355 (2001) (discussing the desirability of immunologically compatible despite the immunosuppressive drugs), available at http://ndt.oxfordjournals.org/content/16/2/355.full [http://perma.cc/ lfu5-hxvx]. 37 the waiting list, kidney link, http://www.kidneylink.org/ thewaitinglist.aspx [http://perma.cc/lrn8-2nh8] (last visited nov. 6, 2015). 38 glossary, organ procurement and transplantation network, http://optn.transplant.hrsa.gov/resources/glossary#a [http://perma.cc/ t6r7-t2hz] (last visited nov. 6, 2015). http://dx.doi.org/10.1093/ndt/16.2.355 2016 25 a market for human organs: an ethical solution to the organ shortage pairing schemes are posited as a way to help reduce the organ shortage. each of these options is discussed below. a. technology stem cells are immature cells and have the ability to become any of the body's specialized cells.39 the ability of stem cells to transform into any of the body's cells leads scientists and medical professionals to believe stem cells may be able to cure a medley of health problems.40 for over twenty years, stem cells have been used in bone marrow transplants to help recipients produce healthy white blood cells.41 in 2013, scientists grew a “mini-kidney.”42 this occurrence was the first time researchers have been able to produce a functioning kidney with stem cells.43 although stem cell research has the potential to solve the organ shortage, the technology is likely over a decade away.44 stem cell research is also controversial; however, most of the debate surrounds embryonic stem cell research. the catholic church has no qualms with stem cells obtained licitly, 39 stem cell basics, nat’l inst. health, http://stemcells.nih.gov/info/ basics/pages/basics1.aspx [http://perma.cc/zw27-pg8m] (last visited nov. 30, 2015). 40 the power of stem cells, california inst. for regenerative med., https://www.cirm.ca.gov/patients/power-stem-cells [https:// perma.cc/f7qz-ub4v] (last updated jan. 2015). 41 theodore moore et. al., bone marrow transplantation, medscape, http://emedicine.medscape.com/article/1014514-overview [https:// perma.cc/sef8-4aws] (last updated nov. 7, 2014). 42 jonathan pearlman, kidney grown from stem cells by australian scientists, the telegraph (dec. 16, 2013, 10:28 am), http:// www.telegraph.co.uk/news/worldnews/australiaandthepacific/australia/ 10520058/kidney-grown-from-stem-cells-by-australian-scientists.html [http://perma.cc/6g7b-advg]. 43 id. 44 the associated press, lab-grown organs might be solution to transplant woes, n. y. daily news (june 17, 2013, 2:22 pm), http://www.nydailynews.com/life-style/health/scientists-work-groworgans-transplants-article-1.1374818 [http://perma.cc/m5p5-2dq5]. 26 indiana health law review vol. 13:1 meaning without destroying human life.45 the issue presented by embryonic stem cell research is the same issue presented by abortion: when does life begin? the vatican's statement on the question is, “from the moment the zygote has formed, [it] demands the unconditional respect that is morally due to the human being in his bodily and spiritual totality.”46 embryonic stem cell research results in the death of embryos, viewed as whole persons by the catholic church and many others.47 opponents believe the benefits that may result are outweighed by the destruction of life caused by the stem cell research.48 cloning has potential to solve the organ shortage but presents many of the same issues as stem cell research. there are a variety of different types of artificial cloning. therapeutic cloning is the type most pertinent to the organ shortage as researchers hope to grow organs to replace diseased ones.49 indeed, in 2014, stem cells were cloned and now offer the prospect for new transplant operations.50 as 45 william card. levada & luis f. ladaria, s.i., congregation for the doctrine of the faith: instruction dignitas personae on certain bioethical questions, the vatican (june 20, 2008), http:// www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfa ith_doc_20081208_dignitas-personae_en.html [http://perma.cc/vb5zhlhn]. 46 id. 47 nancy frazier o’brien, embryonic stem-cell research immoral, unnecessary, bishops say, am. catholic, http:// www.americancatholic.org/news/stemcell/ [https://perma.cc/um3htslg] (last visited feb. 4, 2016). 48 id. see also embryonic stem cell research: an ethical dilemma, eurostemcell, http://www.eurostemcell.org/factsheet/embryonic-stemcell-research-ethical-dilemma [https://perma.cc/y2px-3spe] (last updated nov. 5, 2015). 49 cloning, nat’l human genome research inst., http:// www.genome.gov/25020028#al-3 [http://perma.cc/sbn7-86v7] (last updated june 11, 2015). 50 sarah knapton, breakthrough in human cloning offers new transplant hope, the telegraph (apr. 17, 2014, 8:04 pm), http:// www.telegraph.co.uk/news/science/science2016 27 a market for human organs: an ethical solution to the organ shortage therapeutic cloning involves stem cells, many of the same objections are raised against it. in fact, the vatican condemns therapeutic cloning even more harshly than it reprimands reproductive cloning.51 therapeutic cloning results in the destruction of stem cells, and the vatican asserts, “it is gravely immoral to sacrifice a human life for therapeutic ends.”52 a new technology offering a solution to the organ shortage is bioprinting, a form of 3d printing. to provide a very crude description of bioprinting, the 3d printer uses an “ink” composed of cells and a base, usually a hydrogel but sometimes collagen.53 layers of the designed structure are printed atop one another producing the desired design.54 bioprinting is already being used to create various bone implants.55 although functioning organs have not been produced yet, organ prototypes have been successfully bioprinted.56 the adaptability of stem cells makes their use appealing in bioprinting;57 however, the use of stem cells, as previously stated, presents ethical issues. furthermore, 3d printing functional organs is likely decades away.58 therapeutic cloning is in its early stages, so creating functional organs through this means is also likely many news/10774097/breakthrough-in-human-cloning-offers-new-transplanthope.html [http://perma.cc/4wn9-hdth]. 51 card. levada & ladaria, s.i., supra note 45. 52 id. 53 lyndsey gilpin, 3d ‘bioprinting’: 10 things you should know about how it works, techrepublic (apr. 23, 2014, 4:00 am), http://www.techrepublic.com/article/3d-bioprinting-10-things-youshould-know-about-how-it-works/ [http://perma.cc/fg85-hbn5]. 54 id. 55 sarah butler, medical implants and printable body parts to drive 3d printer growth, the guardian (aug. 24, 2014), http:// www.theguardian.com/business/2014/aug/24/medical-implants-drive-3dprinter-growth [http://perma.cc/vv8k-ktem]. 56 gilpin, supra note 53. 57 id. 58 butler, supra note 55. 28 indiana health law review vol. 13:1 years away.59 a more immediate solution to the organ shortage is needed. b. presumed consent presumed consent involves changing the law to classify a decedent as a potential organ donor unless that individual had manifested opposition to donation prior to death.60 legislation, in favor of presumed consent, will almost certainly increase the number of organs available for transplantation.61 hence, spain, often regarded as the model presumed consent nation, has the highest cadaver organ procurement rate in the world.62 the spanish presumed consent model relies heavily on donor coordinators, of which it has many–at least one in each hospital.63 spanish donor coordinators utilize techniques to identify potential donors then attempt to develop a relationship with the donor's family.64 spain also reimburses hospitals for the organ donors they provide.65 in addition to this, education and advertising are part of the spanish 59 vicki glaser, progress in stem cell pluripotency, gen (jan. 15, 2014), http://www.genengnews.com/gen-articles/progress-in-stem-cellpluripotency/5115/?page=2 [https://perma.cc/96fq-m3l3]. 60 alberto abadie & sebastien gay, the impact of presumed consent legislation on cadaveric organ donation: a cross-country study, 25 j. health & econ. 599, 600 (2006) (defining presumed consent), available at http://www.hks.harvard.edu/fs/aabadie/pconsentp.pdf [http:// perma.cc/bc7d-ynq9]. 61 simon bramhall, presumed consent for organ donation: a case against, 93 ann. r. coll. surg. engl. 268, 272 (2011) (stating presumed consent seems like a sure way to increase the organ supply), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3363073/pdf/rcse9304270.pdf [http://perma.cc/r73n-53td]. 62 rafael matesanz et. al., spanish experience as a leading country: what kind of measures were taken? 24 transplant int’l 333, 334 (2011), available at http://onlinelibrary.wiley.com/doi/10.1111/j.14322277.2010.01204.x/epdf [http://perma.cc/eut9-2dgq]. 63 bramhall, supra note 61, at 270-71. 64 id. at 271. 65 id. http://dx.doi.org/10.1016/j.jhealeco.2006.01.003 http://dx.doi.org/10.1308/rcsann.2011.93.4.270 http://dx.doi.org/10.1111/j.1432-2277.2010.01204.x 2016 29 a market for human organs: an ethical solution to the organ shortage model.66 the spanish model has been replicated with success in italy, implying other nations can adopt the model with similar results.67 presumed consent has a practicality to it. the dead have no use for their organs, and those with disease can benefit tremendously from the organs. presumed consent has a high social utility; however, presumed consent does not always work. sweden has adopted presumed consent but has seen no change in its cadaver organ donation rate.68 moreover, the citizens of brazil and france vehemently opposed the introduction of presumed consent.69 the result of attempted presumed consent legislation was an aversion to organ donation in the two countries.70 although spain is heralded as the exemplar of a presumed consent regime, the spanish model does not rely on presumed consent for its success.71 spanish physicians can legally harvest a decedent's organs without a family's consent, but doctors usually respect the wishes of the family.72 spanish procurement officials are financially rewarded based on the number of donors they recruit,73 and one assumes monetary incentives affect procurement performance regardless of the law. perhaps most importantly, the spanish system offers payments to the decedent's family for funeral expenses.74 despite spain's efforts, the waiting list for kidney transplants in spain has not been substantially reduced since presumed consent was implemented.75 66 id. 67 id. 68 id. 69 id. 70 id. 71 t. randolph beard et al., the global organ shortage 43 (2013). 72 id. 73 id. 74 id. 75 ghods & savaj, supra note 9 at 1144 (discussing the success that the spanish model has had with increasing the number of organs 30 indiana health law review vol. 13:1 presumed consent presents legal and ethical problems for the united states. it implies the government owns people at the moment of their death, and this is antithetical to the common law tradition that an individual's rights exist even after death.76 the government claiming dominion over the bodies of the deceased would likely constitute a taking under the fifth amendment and require just compensation. this raises the issue of whether the government would be violating nota, as it would be providing compensation for the decedent’s body when nota forbids exchanging valuable consideration for human organs.77 first amendment religious liberty issues are also likely to arise if presumed consent is implemented in the united states. in any event, over 99% of deaths do not provide transplantable organs,78 so a different solution to the organ shortage must be sought. c. prevention most people on the organ waiting list are there because of preventable disease. over 80% of americans waiting for an organ are in line for a kidney.79 diabetes is the leading cause of kidney failure in the united states accounting for 43.7% of cases,80 and the vast majority of diabetics have type 2 available, but stating that the increase has done little to reduce the shortage). 76 daniel hannan, inventing freedom 141 (2013). 77 42 u.s.c. § 273e(a) (2015). 78 fry-revere, supra note 7. 79 data, supra note 25. (to see current information, follow “data”, “national data”, “select report, choose category, waiting list”, click “candidates”, and “overall by organ.” divide the kidney total by all organs to arrive at the percentage.) 80 high blood pressure and kidney disease, nat’l inst. diabetes & digestive & kidney diseases, http://kidney.niddk.nih.gov/ kudiseases/pubs/highblood/ [http://perma.cc/j4mq-6up7] (last visited nov. 30, 2015). 2016 31 a market for human organs: an ethical solution to the organ shortage diabetes (roughly 27.85 million of the 29.1 million cases).81 high blood pressure is the second leading cause of kidney disease accounting for 28.4% of kidney disease in the united states.82 diet, exercise, maintaining a healthy bodyweight, limiting alcohol consumption, and not smoking can often prevent high blood pressure and type 2 diabetes.83 following these guidelines can also help prevent the need for liver, heart, and other organ transplants. although the solution is simple, government attempts to promote healthier lifestyles will likely meet with controversy in the united states. the affordable care act (“aca”) requires health insurance plans to cover counseling for obesity84 and a myriad of other “free” preventive health services.85 recent polling data shows a majority of americans disapprove of the aca.86 moreover, the aca's future is uncertain as congressional republicans continue their effort to repeal it.87 81 see statistics about diabetes, am. diabetes ass’n (june 10, 2014), http://www.diabetes.org/diabetes-basics/statistics/ [http://perma.cc/ 5xgc-cugl]. 82 high blood pressure and kidney disease, supra note 80. 83 preventing high blood pressure: healthy living habits, ctr. for disease control & prevention, http://www.cdc.gov/bloodpressure/ healthy_living.htm [http://perma.cc/lv68-nkh8] (last updated july 7, 2014). 84 watch your weight, healthfinder.gov, http://healthfinder.gov/ healthtopics/category/health-conditions-and-diseases/diabetes/watchyour-weight#take-action_5 [http://perma.cc/9zz5-r7w9] (last updated sept. 23, 2015). 85 preventive health services for adults, healthcare.gov, https:// www.healthcare.gov/preventive-care-benefits/ [https://perma.cc/2qllc9mw] (last visited nov. 30, 2015). 86 public approval of health care law, realclear politics, http:// www.realclearpolitics.com/epolls/other/obama_and_democrats_health_c are_plan-1130.html [https://perma.cc/7r4w-w7bl] (last visited feb. 8, 2016). 87 jordan fabian, obama vetoes health bill repeal, the hill (jan. 8, 2016), http://thehill.com/homenews/administration/265078-obamavetoes-healthcare-bill-repeal [https://perma.cc/rx7f-2pmf]. 32 indiana health law review vol. 13:1 the american aversion to the aca is symbolic of americans opposition to government interference with their private health choices. former new york city mayor michael bloomberg's proposed soft drink ban was supported by only 36% of the city's residents.88 first lady michelle obama's campaign to encourage healthier lifestyles prompted high school students to blame her for their unappetizing lunches with the hashtag #thanksmichelleobama.89 ultimately, any public health policy's effectiveness is contingent on its acceptance by the targeted population. americans do not seem eager to change their largely unhealthy lifestyles, so prevention, despite its effectiveness, is an unlikely solution to the organ shortage. d. facilitate living donation one way of facilitating organ donation is through paired organ donation. paired donation works by matching an incompatible donor/recipient pair with another incompatible donor/recipient pair. more than two groups of people can be involved in the exchange. donor exchanges enable patients to get organs their bodies are more likely to accept. as paired donation operates via market mechanism, that is trading an incompatible kidney for a compatible kidney, it raises many of the same ethical questions as monetary purchases of organs.90 congress passed the charlie w. norwood living 88 michael m. grynbaum & marjorie connelly, 60% in city oppose bloomberg's soda ban, poll finds, the n.y. times (aug. 22, 2012), http://www.nytimes.com/2012/08/23/nyregion/most-new-yorkers-opposebloombergs-soda-ban.html [http://perma.cc/as5z-tfqz]. 89 laura mandaro, teens tweet gross lunches, say #thanksmichelleobama, usa today (nov. 22, 2014, 9:52 pm), http:// www.usatoday.com/story/news/nation-now/2014/11/22/ thanksmichelleobama-school-lunches-pictures-twitter/ 19415567/ [http:// perma.cc/t6hp-3a5v]. 90 sam crowe et al., increasing the supply of human organs: three policy proposals, the president's council on bioethics (2007), 2016 33 a market for human organs: an ethical solution to the organ shortage organ donation act in 2007 clarifying that paired donation does not violate nota.91 since the act's passage, the kidney waiting list has grown implying paired donation is not the solution to the organ shortage. this is not surprising because barter is an inefficient method of allocating resources.92 another way of increasing the number of living donors is to make donation less burdensome. traveling and time spent getting evaluated for donation can be expensive. medical professionals recommend eight weeks for recovery post donation.93 during this period, the donor still has to pay rent and other expenses, so even the most willing of donors may not be able to afford to donate. the organ recipient can reimburse donors for some of these expenses; however, only recipients with sufficient wealth can afford to do this.94 a government program, the national living donor assistance center, provides up to $6,000 of pre-transplant expenses for those living with an income of 300% of the poverty level or below.95 insurance or another program may help those with incomes above this level during the pre-transplant phase. aside from medical care, donors receive little help posttransplant. https://bioethicsarchive.georgetown.edu/pcbe/background/increasing_su pply_of_human_organs.html [https://perma.cc/9cfd-qxyq]. 91 charlie w. norwood living organ donation act, pub. l. no. 110144, 121 stat. 1813 (2007). 92 gary s. becker & julio j. elias, cash for kidneys: the case for a market for organs, the wall st. j., http:// www.wsj.com/articles/sb100014240527023041494045793225600048171 76 [http://perma.cc/zgp8-wasa] (last updated jan. 18, 2014, 4:58 pm) [hereinafter cash for kidneys]. 93 faq: living kidney donor, univ. california san francisco med. ctr., http://www.ucsfhealth.org/education/living_kidney_donor/ #24 [http://perma.cc/z3hu-5u2l] (last visited nov. 30, 2015). 94 crowe et al., supra note 90. 95 nat’l living donor assistance ctr., living organ donors: assistance with travel, lodging and meals, available at https:// www.livingdonorassistance.org/documents/nldac_program_brochure. pdf [https://perma.cc/qn2n-tcsr] (last visited nov. 30, 2015). 34 indiana health law review vol. 13:1 enabling charities, private individuals, or the government to provide financial assistance to donors makes sense. the american living organ donor fund (“alodf”) is a private charity that helps donors with postoperative expenses,96 but the alodf is operating in a legal gray area due to nota's prohibition on offering “valuable consideration” in exchange for human organs. over a dozen states provide tax incentives to facilitate donations of organs and marrow; nevertheless, these state tax breaks have not increased donation rates.97 although payment for organs is illegal, donors should not suffer financially in the aftermath of their beneficent act.98 reducing the economic strain of donors will increase donations, but probably will not end the organ waiting list. iv. organ market ethical issues perhaps the most obvious solution to the organ shortage is creating a market for human organs. basic economics states if the price of a good increases more people will be willing to supply the good.99 the concept is so natural that soon after antirejection drugs enabled transplants to occur between diverse peoples an international organ market was proposed.100 under the proposal, americans would be allowed to purchase the organs of impoverished citizens of 96 mission, am. living organ donor fund, http:// www.helplivingdonorssavelives.org/about-us/our-mission/ [http://perma.cc/c2gj-jmaj] (last visited nov. 30. 2015). 97 tax incentives and organ donation, am. transplant found. (nov. 15, 2012), http://www.americantransplantfoundation.org/2012/ 11/15/tax-incentives-and-organ-donation/ [http://perma.cc/6hcn-8nry]. 98 mission, supra note 96. 99 al ehrbar, supply, library econ. & liberty (2008), http://www.econlib.org/library/enc/supply.html [http://perma.cc/3qerwsak]. 100 susan hankin denise, regulating the sale of human organs, 71 va. l. rev. 1015 (1985) (discussing barry jacobs’ proposed organ market). http://dx.doi.org/10.2307/1072918 2016 35 a market for human organs: an ethical solution to the organ shortage the third world.101 public outrage prompted nota, and its prohibition on organ sales.102 virtually every country has banned the organ trade. .103 countless organizations including the united nations,104 american medical association (“ama”),105 and the catholic church106 have condemned the market for human organs. underlying most objections to the organ market are principles of fairness and corruption. the fairness argument is premised on the notion that people are entering the market with unequal bargaining power; therefore, one party has the ability to unduly coerce the other.107 accordingly, true mutual consent cannot be obtained in the transaction.108 for example, the wealth gap between the richest and poorest americans prevents a fair exchange between the groups— especially for something as important an organ. the fairness objection is amplified by the possibility of wealthy citizens 101 id. at 1022. 102 id. at 1023-24. 103 lisanne denneman & marianne mol, organ trade: a win-win situation or exploitation in disguise?, global med. 19 (nov. 2010), http://e.issuu.com/embed.html#10443465/30247857 [http://perma.cc/ 3ajt-b3rj]. 104 arthur caplan et al., trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs, joint council europe/united nations study 30 (2009), http:// www.coe.int/t/dghl/monitoring/trafficking/docs/news/organtrafficking_ study.pdf [http://perma.cc/k97r-sgd5]. 105 opinion 2.15-transplantation of organs from living donors, am. med. ass’n, http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics/opinion215.page [http://perma.cc/3sw5-k2tg] (last updated june 2011). 106 pope john paul ii, address of the holy father john paul ii to the 18th international congress of the transplantation society (aug. 29, 2000), http://w2.vatican.va/content/john-paul-ii/en/speeches/2000/jul-sep/ documents/hf_jp-ii_spe_20000829_transplants.html [http://perma.cc/tp9r-jdsx]. 107 michael j. sandel, what money can't buy: the moral limits of markets, the tanner lectures on human values 112 (may 11-12, 1998), http://tannerlectures.utah.edu/_documents/a-to-z/s/sandel00.pdf [http://perma.cc/3agq-7nkn]. 108 id. 36 indiana health law review vol. 13:1 from around the globe purchasing organs from poor denizens of the world's most impoverished nations. the living standards are so vastly different in some countries that citizens of wealthy countries can basically purchase organs for free.109 if the organ market is legalized, proponents of the fairness argument fear the rich will come to view the poor as organ banks.110 corruption is the other morality-based argument made by organ market opponents. the corruption argument asserts some things should not be commoditized because putting a price on a thing diminishes it.111 human organs are considered by some opponents of an organ market to be outside the commercial sphere and should be treated exclusively as gifts.112 following the kantian tradition, treating organs as commodities diminishes the inherent dignity of human beings by treating people as a means rather 109 gdp per capita, the world bank, http://data.worldbank.org/ indicator/ny.gdp.pcap.cd?order=wbapi_data_value_2014+wbapi_dat a_value+wbapi_data_value-last&sort=asc. gross domestic product per capita can serve as a proxy for average annual income in a country. using united states dollars, world bank data shows malawi had the lowest gdp per capita in 2014 at $255 and luxembourg had the highest gdp per capita at $116,664.3. this means malawi's average gdp per capita is less than one percent of the average luxembourg citizen's gdp per capita. consequently, a wealthy individual from luxembourg can spend less than one percent of her annual income on a kidney from a malawian, and this transaction would result in the malawian exceeding his annual income. this is particularly true if the malawian is poor by the country's standards. 110 brian resnick, living cadavers: how the poor are tricked into selling their organs, the atlantic (mar. 23, 2012), http:// www.theatlantic.com/health/archive/2012/03/living-cadavers-how-thepoor-are-tricked-into-selling-their-organs/254570 [http://perma.cc/ 4gjw-lw4e]. 111 sandel, supra note 107, at 112. 112 julia d. mahoney, altruism, markets, and organ procurement, 72 law & contemp. probs. 17, 17 (2009), available at http:// scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1535&context=lcp [http://perma.cc/qv2a-qmcf]. 2016 37 a market for human organs: an ethical solution to the organ shortage than an end.113 pope john paul ii aligned himself with kant by stating, “any procedure which tends to commercialize human organs or to consider them as items of exchange or trade must be considered morally unacceptable, because to use the body as an ‘object’ is to violate the dignity of the human person.”114 aside from devaluing life, opponents of organ markets assert organ selling violates the medical principle of “do no harm” because extracting an organ harms the provider purely for commercial reasons.115 nonetheless, some who assert that exchanging money for organs is unacceptable would permit certain forms of nonmonetary compensation for donors. suggested nonmonetary rewards for donation include a donor medal-ofhonor and insurance coverage.116 interestingly, reimbursing donors for funeral expenses also constitutes a nonmonetary incentive.117 a small amount, $300, is considered a sign of appreciation and not a payment; plus, the payment is made after the donor's death.118 the difference between these signs of appreciation and money are symbolic, but organ market opponents think symbols matter.119 the distinction between 113 susan m. shell, chapter 13: kant's concept of human dignity as a resource for bioethics in human dignity and bioethics: essays commissioned by the president’s council on bioethics, the president's council on bioethics (mar. 2008), https:// bioethicsarchive.georgetown.edu/pcbe/reports/human_dignity/ chapter13.html [http://perma.cc/pnw9-ljb3]. 114 pope john paul ii, supra note 106. 115 arthur caplan, chapter 28: organ transplantation in from birth to death and bench to clinic: the hastings center bioethics briefing book for journalists, policymakers, and campaigns, the hastings ctr. 131 (2008), http://www.thehastingscenter.org/uploadedfiles/ publications/briefing_book/organ%20transplantation%20chapter.pdf [http://perma.cc/rqb7-fl2y]. 116 francis l. delmonico et al., ethical incentives—not payment— for organ donation, 346 n. engl. j. med. 2002, 2003 (2002), available at http://eml.berkeley.edu/~webfac/held/delmonico.pdf [http://perma.cc/55vv-tcw6]. 117 id. 118 id. 119 id. at 2004. http://dx.doi.org/10.1056/nejmsb013216 38 indiana health law review vol. 13:1 expressing gratitude for an organ and buying the organ is analogous to giving a friend a bottle of wine as thank you versus handing him cash.120 appeals to fairness and corruption neither alleviate the organ shortage, nor do they benefit the people prohibition is supposed to protect. these concerns both hinge in part on the possibility of exploitation of the poor resulting from the coercive purchasing power of the rich. financial pressure affects the poor more than the rich making it unfair, and coercion violates the individual's humanity by disrupting his free will. however, objections based on financial pressure are almost entirely irrelevant in a market for cadaver organs, as the dead cannot be coerced. people vend organs to improve their earthly lives rather than to gain rewards in the afterlife. in the organ market, financial coercion arises from discrepancies in wealth in favor of the buyer. what if the script is flipped and billionaire bill gates wants to sell his kidney to a poor pakistani? similarly, what if people with equivalent levels of wealth want to enter a transaction for a kidney? objections to the organ market premised on monetary coercion are more difficult to sustain when the playing field is leveled or tilted in the other direction. if a market for human organs is legalized, it seems probable that the majority of organ sellers will be poor.121 however, barring an activity is not justified simply because a majority of people participating in the activity are poor. the indigent shine shoes, mine coal, and engage in various other trades that the rich do not because they are poor.122 120 id. 121 gary s. becker & julio jorge elias, introducing incentives in the market for live and cadaveric organ donations, 21 j. econ. perspectives 3, 21 (2007) (discussing criticisms of an organ market), available at http://citeseerx.ist.psu.edu/viewdoc/ download?doi=10.1.1.335.4572&rep=rep1&type=pdf [http://perma.cc/ 5qke-zgaa] (hereinafter introducing incentives). 122 sunny woan, buy me a pound of flesh: china's sale of death row organs on the black market and what americans can learn from it, 47 santa clara l. rev. 413, 439 (2007). http://dx.doi.org/10.1257/jep.21.3.3 2016 39 a market for human organs: an ethical solution to the organ shortage prohibiting opportunities to earn money does not improve the condition of those in poverty. an additional point to consider regarding kidney sales is 3 of 10,000 living kidney donors die during the operation,123 accordingly, death during a kidney removal operation is lower than the risk of death in common occupations like refuse collector (3.58 per 10,000) and roofer (4.62 per 10,000).124 the risk of death during kidney donation is substantially lower than the risk of death in the legal commercial fishing industry, which has an annual fatality rate of 12.4 per 10,000 workers.125 divers and those employed in various other occupations receive additional pay for taking on jobs that pose high risks to their health.126 preventing people from choosing what risks are acceptable in their quest to earn a living is “paternalism in its worst form.”127 although shielding the poor from abuse by the wealthy is a purpose of prohibiting organ sales, prohibition has created the black market.128 a summit representing numerous organizations that oppose the sale of human organs acknowledged that the shortage of organs, caused at least in part by prohibition, has led to undesirable and unethical 123 living donors, nat’l kidney registry, http:// www.kidneyregistry.org/living_donors.php?cookie=1 [http://perma.cc/ u8el-kllf] (last visited nov. 30, 2015). 124 bureau of labor statistics, nat’l census of fatal occupational injuries in 2014 (preliminary results) 4 (sep. 17, 2015), http://www.bls.gov/news.release/pdf/cfoi.pdf [http://perma.cc/ abp8-m7sf]. 125 commercial fishing safety, ctr. disease control & prevention, http://www.cdc.gov/niosh/topics/fishing/ nationaloverview.html [https://perma.cc/5trn-jsde] (last updated oct. 28, 2014). 126 j. savulescu, is the sale of body parts wrong?, 29 j. med. ethics 138, 139 (2003), available at http://jme.bmj.com/content/29/3/ 137.full.pdf+html [http://perma.cc/lnn2-jans]. 127 id. 128 the black market is discussed in greater depth in the following section. the cursory discussion occurring here is simply to an answer an objection to the organ market rather than provide a thorough analysis of the black market. http://dx.doi.org/10.1136/jme.29.3.138 40 indiana health law review vol. 13:1 outcomes such as the black market.129 all of the legal organ market opponents’ worst fears are happening in the underground trade of human organs, and are caused by prohibition.130 people from wealthy countries routinely purchase organs (usually kidneys) from impoverished citizens of the third world.131 black market transactions are often exploitative and make the transplant process itself extra risky.132 seller health erodes substantially after black market operations.133 buyers are at high risk of contracting diseases like hiv and have much lower survival rates than when transplants are performed in a proper medical environment.134 129 the declaration of istanbul on organ trafficking and transplant tourism, the transplantation soc’y & int’l soc’y nephrology 1 (apr. 30-may 2, 2008), http://multivu.prnewswire.com/mnr/ transplantationsociety/33914/docs/33914-declaration_of_istanbullancet.pdf [http://perma.cc/n7c7-xluz]. 130 dominique martin, medical travel and the sale of human biological materials: suggestions for ethical policy development, 10 global soc. pol’y 377, 385 (2010) (noting that prohibition likely causes the ethical problems banning organ sales is supposed to prevent). 131 nancy scheper-hughes, parts unknown: undercover ethnography of the organs-trafficking underworld, 5 ethnography 29, 33 (2004), available at http://www.uky.edu/~tmute2/ geography_methods/readingpdfs/scheper-hughes-partsunknown.pdf [http://perma.cc/jr3k-bbkf] (discussing how transplant technology has spread to the developing world and how the poor have become a source of organs for the privileged). 132 l d de castro, commodification and exploitation: arguments in favour of compensated organ donation, 29 j. med. ethics 142, 145 (2003), available at http://jme.bmj.com/content/29/3/142.full.pdf+html [http://perma.cc/qqw9-wgxx] (discussing how prohibiting organ sales does not protect those who are participating in illegal organ operations). 133 vivekanand jha, paid transplants in india: the grim reality, 19 nephrology dialysis transplantation 541, 542 (2004), available at http://ndt.oxfordjournals.org/content/19/3/541.full.pdf+html [http:// perma.cc/lqg3-r77l]. 134 david b. samadi, consequences of the rise of illegal organ trafficking, fox news (may 30, 2012), http://www.foxnews.com/ health/2012/05/30/consequences-rise-in-illegal-organ-trafficking/ [http://perma.cc/lqg3-r77l]. http://dx.doi.org/10.1177/1468018110379979 http://dx.doi.org/10.1177/1466138104041588 http://dx.doi.org/10.1136/jme.29.3.142 http://dx.doi.org/10.1093/ndt/gfg576 2016 41 a market for human organs: an ethical solution to the organ shortage the ghoulish outcomes produced by the black market are nonexistent in proper clinical settings. parting with a kidney should present the same risk regardless of whether the kidney is available because of charitable or commercial motives, because the procedure is the same regardless of the organ provider's motivation. kidney donation is a fairly safe procedure. in fact, johns hopkins medicine states “donors tend to do as well or better than the general population in regard to long term medical complications.”135 the legality of donation allows donors to receive proper medical care post operation. when things go poorly during donation, the law provides recourse to donors. this grants donors protection from medical mishaps. furthermore, donors must undergo a screening process to legally donate an organ.136 the black market has no such vetting process; hence, the vulnerable are at much greater risk of predation in illicit organ transactions. accordingly, providing a legal framework for organ sales is the best way to prevent unfair transactions that exploit the poverty-stricken.137 fairness may be a stated reason to prevent the organ market, but the impacts of the organ shortage are not fair. minorities are more likely to suffer from kidney disease than 135 karl womer, what kidney donors need to know: before, during, and after donating a kidney, johns hopkins med. comprehensive transplant ctr., http://www.hopkinsmedicine.org/transplant/news_events/media/transcri pts/kidney_pancreas/what_kidney_donors_need_to_know.html [http://perma.cc/aml3-p4sm] (last visited nov. 30, 2015). 136 donor screening and testing, ctr. disease control & prevention, http://www.cdc.gov/transplantsafety/ screening_testing.html [http:// perma.cc/4gvj-34hj] (last updated june 17, 2013). 137 j. radcliffe-richards et al., the case for allowing kidney sales, 351 the lancet 1950, 1951-52 (1998) available at http:// www.thelancet.com/journals/lancet/article/piis0140-6736(97)082111/fulltext [http://perma.cc/2f8m-5svf] (asserting that exploitation is more likely to occur in illegal activities). http://dx.doi.org/10.1016/s0140-6736(97)08211-1 42 indiana health law review vol. 13:1 whites.138 blacks and latinos are less likely to be placed on organ waitlists than whites because doctors do not refer nonwhites to transplant centers as frequently as physicians refer whites.139 even assuming blacks and whites are placed in the kidney queue at the same time, blacks wait an average of 74% longer than whites to receive a kidney.140 interestingly, kidneys are the only organ that matching is a criteria rather than first-in-line status and medical need.141 matching seems like a medically neutral criteria, but it has racially disparate impacts. a federal appellate court noted that people with diverse genes have a tougher time finding genetic matches, such as blacks who often have a “mix of african, caucasian, and native-american genes.”142 in fact, blacks are only one-tenth as likely as whites to find a perfect match.143 kidneys also happen to be the organ that blacks need most disproportionately to whites.144 moreover, research indicates tissue matching is not an accurate predictor of transplant outcomes.145 the organ shortage not only causes treatment discrepancies based on race but also wealth and status. money is not explicitly considered in organ distribution; nevertheless, a person with means has an advantage over those who lack resources.146 the rich can legally purchase 138 race/ethnicity and kidney disease, am. kidney fund, http:// www.kidneyfund.org/are-you-at-risk/risk-factors/race-kidney-disease/ [http://perma.cc/2zcg-wlhc] (last visited nov. 30, 2015). 139 michele goodwin, black markets: the supply and demand of body parts 90-91 (2006). 140 id. at 96. 141 id. at 97. 142 flynn v. holder, 684 f.3d 852, 857 (2011). 143 goodwin, supra note 139, at 103. 144 id. at 97. 145 matching and compatibility, u.c. davis health sys., http://www.ucdmc.ucdavis.edu/transplant/livingdonation/donor_compati ble.html [http://perma.cc/c9lr-xkdp] (last visited nov. 30, 2015). 146 ray hainer, did steve jobs' money buy him a faster liver transplant?, cnn, http://www.cnn.com/2009/health/06/24/ 2016 43 a market for human organs: an ethical solution to the organ shortage billboards and other forms of publicity that the poor cannot, and the ama deems donations resulting from public solicitation ethical.147 advertising increases the advertiser’s odds of receiving a directed organ donation, giving the rich an advantage over the poor in organ procurement. wealthy citizens can also circumvent organ waiting lists by having residences in multiple states, and this enables wealthy individuals to be added to the organ waiting list in multiple jurisdictions.148 this gives the rich an advantage over the poor.149 likewise, the rich can afford to engage in transplant tourism while the poor languish in organ queues because the poor lack the financial wherewithal to purchase organs on the black market.150 regarding status, pennsylvania governor robert casey received a heart and liver transplant simultaneously within 24 hours of being placed on the wait list.151 ethicists determined casey did not receive preferential treatment, but his political office and wealth created the public perception that casey benefitted from his status.152 the belief that the body is sacred and organ sales will corrupt its sanctity is a legitimate position. convincing liver.transplant.priority.lists/index.html?iref=24hours [http://perma.cc/86xy-rgjd] (last updated june 24, 2009, 11:29 am). 147 opinion 2.15-transplantation of organs from living donors, supra note 105. 148 cash for kidneys, supra note 92. 149 judith randal, mantle's transplant raises delicate issues about organ allocation, 88 j. nat’l cancer inst. 484, 484 (1996), available at http://jnci.oxfordjournals.org/content/88/8/484.full.pdf [http://perma.cc/ nqa3-vdvr]. 150 henriette johansen, lebanon’s black market in refugee organs, middle e. monitor (jan. 5, 2014, 8:52 pm), https:// www.middleeastmonitor.com/blogs/lifestyle/9067-lebanons-blackmarket-in-refugee-organs [http://perma.cc/elt3-7dzc] (noting that rich arabs fly to beirut for transplants, even though buying organs is illegal. presumably the poor are not doing this.). 151 claudia coates, casey’s quick transplant renews ethics debate, l.a. times (july 25, 1993), http://articles.latimes.com/1993-07-25/news/ mn-17587_1_heart-transplant [http://perma.cc/qs7l-qqz7]. 152 id. http://dx.doi.org/10.1093/jnci/88.8.484 44 indiana health law review vol. 13:1 someone with this position of the potential benefits of an organ market is unlikely. one assumes this objection is held in good faith; however, it is worth pointing out that opponents of kidney sales have bought organs.153 high minded positions are easy to take when the position holder is not the one suffering and staring death in the face. furthermore, it is most peculiar that the medical personnel who perform the transplant are paid; the site of the transplant charges a fee; the organ recipient is able to exchange money for the gift of life; yet the person who makes the procedure possible–the organ provider–cannot be compensated without corrupting the procedure.154 in fact, current law allows a form of compensation to organ donors because paired organ donation is legal.155 paired donation is not considered corrupting, akin to the wine example above; rather, paired donation is considered altruistic.156 professor richard epstein calls allowing paired donation while prohibiting purchases “baloney” because paired donation is a “market for barter.”157 there is no practical difference between a trade and a cash transaction. the purpose of the organ transaction is to save lives, so a market provides the most efficient mechanism for facilitating lifesaving organ transplants.158 plus, money is provided as a 153 sigrid fry-revere, the kidney sellers 95 (2014). 154 charles a. erin & john harris, an ethical market in human organs, 29 j. med. ethics 137, 137 (2003), available at http:// jme.bmj.com/content/29/3/137.full.pdf [http://perma.cc/8sa2-48ze]. 155 42 u.s.c. § 274e(a) (2015). 156 richard epstein, the economics of organ donations: econtalk transcript, library econ. & liberty (june 5, 2006), http:// www.econlib.org/library/columns/y2006/epsteinkidneys.html [http://perma.cc/rwt6-7vwm]. 157 id. 158 nicholas capaldi, a catholic perspective on organ sales, 6 christian bioethics 139, 145 (2000), available at http:// www.ualberta.ca/~dcl3/ref_2007-aug17/commercialization%20and%20health%20policy%20or%20forecasti ng%20etc/commercialization_body+parts_catholic+perspective.pdf [http://perma.cc/bf74-m7w7]. http://dx.doi.org/10.1136/jme.29.3.139 2016 45 a market for human organs: an ethical solution to the organ shortage gift without denigrating the recipient in various situations such as birthdays, weddings, and baptisms.159 this may be why the ama's council for ethical and judicial affairs has determined there is nothing inherently unethical about an organ market.160 although the law prohibits organ sales, sales occur and little is done to stop them. sending people to jail who would not be alive but for the organ they illegally purchased strikes most people as unjust. likewise, sending organ sellers to jail who have sacrificed their bodies so that another may live is equally deplorable. organ market opponents may object to the market despite the seeming immorality of punishing market participants. nevertheless, prohibiting the organ market is not practical. the law cannot stamp out all unseemly occurrences, so thomas aquinas believed the law should target actions that affect parties who do not consent to the activity like murder and rape.161 aquinas would agree the black market in human organs is repugnant and desire its end. determining an end is only half of the equation– devising a means to practically achieve the objective is the other half.162 the organ market opponent goal of preventing body defilement is best realized by creating a market where the rule of law governs transactions. this may be why pope pius xii left open the possibility of an organ market noting, “[i]t would be going too far to declare immoral every acceptance or every demand of payment.”163 159 l d de castro, supra note 132 (discussing the various situations when money is given as a gift or incentive). 160 deborah josefson, united states starts to consider paying organ donors, 324 brit. med. j. 446, 446 (2002), available at http:// www.ncbi.nlm.nih.gov/pmc/articles/pmc1172054/ [http://perma.cc/ a3gs-n3rs]. 161 thomas aquinas, on law, morality, and politics 62 (william p. baumgarth & richard j. regan, 2d ed. 2002). 162 t. hoffman, aquinas on the nature of prudence, http:// faculty.cua.edu/hoffmann/courses/769_1081/769_summary_2a2ae.47.pdf [http://perma.cc/8eh4-nwnj] (last visited nov. 30, 2015) (discussing prudence in action in 47.8 c summary section). 163 capaldi, supra note 158, at 141. http://dx.doi.org/10.1136/bmj.324.7335.446/c 46 indiana health law review vol. 13:1 arguments based on fairness and corruption do not address the question of whether a market for organs would increase the supply of organs. indeed, some opponents of organ markets assert providing financial compensation for organs would decrease the quantity, as well as the quality, of organs available for transplant. this theory is based largely on richard titmuss's 1971 study of the blood supply in england and the united states.164 during the period of titmuss's observation, blood sales were illegal in the united kingdom but legal in the united states.165 titmuss found the quality and quantity of blood supply in the united kingdom was superior to the blood supply in the united states.166 titmuss concluded the american system leads to higher costs as well as greater risks of contaminated blood and chronic blood shortages.167 this prompted titmuss to conclude americans viewed blood as a commodity, so americans were less likely to donate blood.168 although people were allowed to donate blood in the united states, titmuss theorized donations were crowded out by purchases.169 titmuss believed replacing charity with a market would have deleterious effects on altruism in a 164 amy crawford, the trouble with organ banking, boston globe (june 1, 2014), https://www.bostonglobe.com/ideas/2014/05/31/thetrouble-with-organ-banking/gaugdq7gmnes8mkwissaym/story.html [https://perma.cc/e5kc-a3j3]. see also cynthia b. cohen, public policy and the sale of human organs 12 kennedy inst. of ethics j. 47, 54, available at http://www.hawaii.edu/religion/courses/organsale2.htm [https://perma.cc/sd6r-8nfc] (stating “titmuss's views about the importance of the gift relationship were brought back into public discussion with respect to the sale of kidneys."). 165 s. m. rothman & d. j. rothman, the hidden cost of organ sale, 6 am. j. transplantation 1524, 1525 (2006), available at http:// www.societyandmedicine.columbia.edu/organs_challenge.shtml [http:// perma.cc/hh9t-pbw2]. 166 iain mclean, the gift relationship, policy-network.net, http://www.policy-network.net/publications_download.aspx?id=6839 [http://perma.cc/u2tq-nfky] (last visited nov. 30, 2015). 167 sandel, supra note 107, at 123. 168 id. at 124. 169 id. http://dx.doi.org/10.1353/ken.2002.0002 http://dx.doi.org/10.1111/j.1600-6143.2006.01325.x 2016 47 a market for human organs: an ethical solution to the organ shortage society.170 more recent studies support titmuss's hypothesis. one such study involved an israeli daycare where tardy parents were fined. when fines of $2.50 were imposed, the number of late pickups increased.171 when the fine was removed, the tardiness persisted.172 this implies that placing a price on organs will create a permanent commercial stigma around organs and removal of the price will not necessarily revert social perceptions on organ donations to the way they were pre-commodification. the impact of commercialization on blood quantity and quality has been well rebutted. at the time of titmuss's writing, blood screening tests were not prevalent.173 modern blood testing mitigates titmuss's fear of harvesting the blood of skid row donors infected with hepatitis and other blood borne diseases who are looking for money.174 regarding the effect of money on the quantity of blood, the united states blood supply is obtained almost entirely from altruistic donors.175 however, the united states pays plasma providers.176 blood shortages are chronic in the united states, but the united states has a plasma surplus and is a plasma exporter.177 likewise, organ procurement systems that offer compensation, including spain discussed supra and iran discussed infra, have better organ procurement rates than other systems.178 this trend strongly suggests that financial incentives will increase the organ supply. turning to the altruism claim, multiple motives go into most actions. paying donors may send social signals that contradict the charity motivation.179 nevertheless, the key message from 170 id. 171 rothman & rothman, supra note 165, at 1525. 172 id. 173 beard et al., supra note 71, at 98. 174 id. 175 id. at 184. 176 id. 177 id. at 99. 178 id. 179 id. at 98-99. 48 indiana health law review vol. 13:1 the israeli example is to provide significant compensation or no compensation at all.180 recent research also indicates market incentives may actually increase altruistic behavior.181 putting aside all other arguments, the ability to control what happens to one's own body is a matter of freedom. it seems odd for the government to prevent people from making choices that affect only their own body, and this is the fundamental issue involved in the organ market. one may counter this by pointing out that the same principle applies to prostitution and drug use, yet the government prohibits these activities. however, there is a crucial distinction between the aforementioned activities and the ability to sell one's organs. drug use and prostitution, although they involve only willing participants, are seldom thought to be a social benefit. on the contrary, organ vending has tremendous social value. a life is saved through this consensual transaction, and human suffering is reduced. the vendor stands to benefit from the transaction as well through the receipt of money and the satisfaction of saving a life. if the vendor did not think the transaction was in her best interest, the vendor would not consent to the agreement. a financial incentive does not diminish the nobility of a deed. the salaried firefighter who risks his life by running into a flaming house to rescue a child is not less valiant than a volunteer firefighter. american soldiers are not less brave because they receive pay. a person need not sacrifice everything and be unrewarded to perform a worthy feat. for this reason, professor nicholas capaldi asserts, “[t]he forprofit sale of an organ or the acceptance of recompense does not of itself reduce organ donation to a mere instrumental use of the body; it thus does not in itself render the donation 180 id. at 99. 181 cary deck & erik o. kimbrough, do market incentives crowd out charitable giving?, 47 j. socio-econ. 8 (2013), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3857091/./ [http:// perma.cc/t95f-efau]. http://dx.doi.org/10.1016/j.socec.2013.08.007 2016 49 a market for human organs: an ethical solution to the organ shortage less morally praiseworthy.”182 accordingly, it matters not whether organs are provided to those in need by altruism or a commercial transaction. the organ recipient's life is saved by receiving the organ—not by the method used to procure the organ. people have the right to engage in all sorts of dangerous activities. the government permits cigarette smoking though smoking has no health benefits; in fact, smoking kills 480,000 americans each year.183 not only are people allowed use harmful drugs for recreation, people are allowed to engage in dangerous hobbies. base jumping may be the most dangerous hobby, as it has a fatality rate of 40 per 100,000 jumps;184 therefore, base jumping is statistically more dangerous than donating a kidney. aside from base jumping, people are free to sky dive, hang glide, mountain climb, and engage in numerous other inherently hazardous activities. people can even earn a living performing some these activities.185 if people are allowed to consume cancer sticks and engage in unsafe hobbies, why should competent adults be forbidden from receiving compensation for their organs when the transaction will save a human life? americans have a fundamental right to create life.186 procreation can cost nothing but can also be rather pricey as sperm and eggs can be purchased. in vitro fertilization and surrogate mothers are very expensive. these, especially surrogacy, present similar ethical issues to an organ market, and a powerful argument can be made that the questions 182 capaldi, supra note 158, at 142. 183 health effects infographics, ctr. disease control & prevention (feb. 27, 2015), http://www.cdc.gov/tobacco/data_statistics/ tables/health/attrdeaths/ [http://perma.cc/45ym-yhdf]. 184 k. soreide et al., how dangerous is base jumping? an analysis of adverse events in 20,850 jumps from the kjerag massif, norway, 62 j. trauma 1113 (2007), available at http://www.ncbi.nlm.nih.gov/ pubmed/17495709 [http://perma.cc/mpy6-yewz]. 185 base jumper, inside jobs, http://www.insidejobs.com/careers/ base-jumper [http://perma.cc/9npp-x8v8] (last visited nov. 30, 2015). 186 skinner v. oklahoma, 316 u.s. 535 (1942). http://dx.doi.org/10.1097/01.ta.0000239815.73858.88 50 indiana health law review vol. 13:1 involved in procreation using artificial methods set society on a slope far slipperier than an organ market. organ transplantation is a widely accepted medical procedure, even by organizations that oppose organ selling. the vatican, for example, approves of organ transplants.187 however, the vatican categorically opposes "designer babies" because, "[t]he fact that someone would arrogate to himself the right to determine arbitrarily the genetic characteristics of another person represents a grave offense to the dignity of that person as well as to the fundamental equality of all people."188 yet to exercise the right to procreate, money can be legally used in the united states. why is spending money to create a life acceptable while using money in a mutually beneficial transaction to preserve a life is deemed illicit? american law allows the use of deadly force in selfdefense; indeed, self-defense is often regarded as the first law of nature.189 the united states also allows the use of deadly force to defend another person.190 the life of a viable fetus can be terminated “when it is necessary to preserve the life or health of the mother.”191 in the united states, force or violence can be used to prevent “trespass against property in 187 address of the holy father john paul ii to the 18th international congress of the transplantation society, libreria editrice vaticana (aug. 29, 2000), http://w2.vatican.va/content/john-paul-ii/en/speeches/ 2000/jul-sep/documents/hf_jp-ii_spe_20000829_transplants.html [https:// perma.cc/s8zv-rvfy]. the vatican is not categorically opposed to an organ market. see supra note 158. 188 instruction dignitas personae on certain bioethical questions, congregation for the doctrine of the faith, http:// www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfa ith_doc_20081208_dignitas-personae_en.html [https://perma.cc/2qkgpnc7] (last visited feb. 4, 2016). 189 saul cornell, natural rights, common law, and the english right of self-defense, 14 insights on law and soc’y (2013), available at http://www.americanbar.org/publications/insights_on_law_andsociety/14 /fall-2013/natural-rights--common-law--and-the-english-right-of-selfdefens.html [http://perma.cc/ll4l-q47e]. 190 la. stat. ann. § 14:22 (2015). 191 roe v. wade, 410 u.s. 113 (1973). 2016 51 a market for human organs: an ethical solution to the organ shortage a person's lawful possession . . . .”192 the law allows selfdefense and defense of property even though these claims may be used to protect a criminal.193 similarly, allowing abortions for the health of the mother can, “become a tool for abortions anytime, for any reason.”194 on this basis, professor eugene volokh asserts people have the right to “medical self-defense” when diagnosed with a terminal condition.195 if an individual can legally kill another human being to preserve her life and violently defend property from trespass, surely she should be allowed to enter a consensual commercial transaction to save her life. v. money for organs this section examines the two systems where organ providers are compensated: the black market and the iranian kidney system. the discussion of each market begins with an overview of their history and circumstances leading to their creation. a discussion of how each market operates follows. by nature, the black market has no formal process, so the discussion generalizes how the market operates based upon accounts from various sources. next, the outcomes of each market are examined. as the iranian system has both supporters and detractors, arguments and evidence for each position is weighed. the human organ black market is universally condemned; hence, an analysis its of pros and cons is unnecessary. 192 la. stat. ann. § 14:19 (2015). 193 eugene volokh, medical self-defense, prohibited experimental therapies, and payment for organs, 120 harv. l. rev. 1813, 1817 (2007). 194 kim painter, doctors say abortions do sometimes save women's lives, usa today (oct. 22, 2012), http://www.usatoday.com/ story/news/nation/2012/10/19/abortion-mother-life-walsh/1644839/ [http://perma.cc/87rj-sbx5]. 195 volokh supra note 193, at 1823. 52 indiana health law review vol. 13:1 a. black market the black market for human organs is a global enterprise. the illegal organ trade was spawned because a demand existed and the supply was artificially constrained. legislation cannot stop the law of supply and demand.196 as one economist notes, “every time the propensity to exchange is constrained, individuals try to circumvent the constraints in order to obtain what they perceive as the benefits of exchange.”197 regarding the organ market, individuals diagnosed with organ disease have a tremendous demand for functional organs. for the right price, some people are willing to sell their organs. kidneys are particularly marketable because, as judge guido calabresi says, “we all have too many kidneys; we have two, and we really only need one.”198 although the ingredients for a mutually beneficially exchange are in place, most countries prohibit human organ sales placing a price ceiling of zero on all organs.199 predictably, the price ceiling on human organs has caused a shortage of organs, reduced quality of available organs, and created a black market.200 the demand side of the black organ market consists of wealthy, sick patients.201 patients facing certain death or a 196 l d de castro supra note 132, at 142. 197 pierre lemieux, the underground economy: causes, extent, and approaches, montreal econ. inst. research papers 10 (nov. 2007), http://www.iedm.org/files/cdr_nov07_en.pdf [http://perma.cc/3rxnf68n]. 198 guido calabresi, do we own our bodies?, faculty scholarship series 15 (1991), http://digitalcommons.law.yale.edu/cgi/ viewcontent.cgi?article=3066&context=fss_papers [http://perma.cc/v4wv-mc29]. 199 aziz, supra note 5, at 68. 200 fiona m. scott morton, the problems of price controls, cato inst. (2001), http://www.cato.org/publications/commentary/problemsprice-controls [http://perma.cc/txt3-lak7]. 201 michael shafer & paige comstock cunningham, medical exploitation and black market organs: profiteering and disparities in global medicine, ctr. bioethics & human dignity (nov. 4, 2011), 2016 53 a market for human organs: an ethical solution to the organ shortage debilitating life on dialysis are willing to pay well over six figures for a kidney.202 these patients often travel to foreign countries and in many cases receive poor quality organs that are not proper matches for their body.203 the organs patients receive frequently have hiv and hepatitis c.204 likewise, proper medical protocols do not have to be followed during illegal operations, so post operation complications are common.205 these complications are difficult to treat when the patient returns to her home country because proper records are not kept on the black market.206 black market buyers often arrange their illegal transplant through organ brokers. organ brokers come from all walks of life, from organized crime syndicates to medical professionals.207 although the organ provider is usually lured into the transaction by money, physical force and subterfuge are used as well.208 organ brokers target the desperately poor from impoverished countries because poverty is the primary reason why individuals sell their body parts.209 individuals https://cbhd.org/content/medical-exploitation-and-black-market-organsprofiteering-and-disparities-global-medicine [http://perma.cc/r95cp9wl]. 202 denis campbell & nicola davison, illegal kidney trade booms as new organ is ‘sold every hour’, the guardian (may 27, 2012), http://www.theguardian.com/world/2012/may/27/kidney-trade-illegaloperations-who [http://perma.cc/klp7-5zug]. 203 kristina fiore, physicians must treat 'transplant tourists’, abc news (jan. 30, 2010), http://abcnews.go.com/health/transplant-tourismhidden-risks/story?id=9702948 [http://perma.cc/vs48-6m84]. 204 nancy scheper-hughes, organ trafficking: a protected crime, the conversation (sep. 3, 2013, 1:50 am), http:// theconversation.com/organ-trafficking-a-protected-crime-16178 [http:// perma.cc/8ekq-lxuz]. 205 fiore, supra note 203. 206 id. 207 organs for sale, united nations regional info. centre for western europe, http://www.unric.org/en/human-trafficking/27447organs-for-sale [http://perma.cc/y6nb-9dpg] (last visited oct. 27, 2015). 208 shafer & comstock cunningham, supra note 201. 209 monir moniruzzaman, "living cadavers" in bangladesh: bioviolence in the human organ bazaar, 26 med. anthropology http://dx.doi.org/10.1111/j.1548-1387.2011.01197.x 54 indiana health law review vol. 13:1 who sell their organs are often completely ignorant as to how the organs operate, and this ignorance enables organ brokers to deceive sellers.210 black market kidney providers typically receive around $1,000.211 in addition to the price of their organs, sellers are promised a myriad of other goodies such as jobs, land, and visas.212 sellers are also told the trip to the transplant site will be jolly.213 tragically, sellers do not have a pleasant experience. they often wait for the transplant in a small, dingy, crowded apartment that functions as a prison.214 attempts to back out of the deal are met by violence.215 the surgery is unnecessarily harsh too. kidneys can be removed with a laparoscope.216 laparoscopic nephrectomy enables the patient to recover quicker than other methods and leaves a smaller scar.217 however, black market operators are not willing use laparoscopes because the procedure costs a few hundred dollars more than using a scalpel. 218 sellers are marked with a 20 inch long scar as a result.219 recovery from the operation takes place in the same dank apartment where the seller was held prior to the surgery.220 although the recovery from the surgery takes weeks, sellers are so desperate to escape the apartment that they head quarterly 69, 75 (2012), available at http://news.msu.edu/ media/documents/2012/03/73a832b2-0893-4837-99fb-9ab6d10db302.pdf [http://perma.cc/qzf2-ggml]. 210 id. at 75-76. 211 shafer & comstock cunningham, supra note 201. 212 moniruzzaman, supra note 209, at 77. 213 id. 214 id. at 78. 215 id. 216 laparoscopic nephrectomy, the james buchanan brady urological inst., http://urology.jhu.edu/mis/lap_nephrectomy.php [http://perma.cc/blw8-432j] (last visited oct. 27, 2015). 217 id. 218 moniruzzaman, supra note 209, at 78. 219 id. at 78. 220 id. 2016 55 a market for human organs: an ethical solution to the organ shortage home a few days post operation.221 this prevents surgical wounds from healing properly.222 sellers also lack access to healthcare; hence, sellers struggle with health problems post surgery.223 physical issues resulting from the operation prevent sellers from engaging in physical labor; thus, the dire economic prospects that drove sellers to part with their organs are usually exacerbated by the organ sale.224 once their organs are extracted, sellers are routinely not paid in full or denied payment altogether.225 sellers do receive the agreed upon sum sometimes; however, this does not ensure they will keep the money. for example, a brazilian kidney seller returned home from south africa three days after the operation with the agreed upon amount in his pocket.226 he was robbed soon after landing.227 the seller had no recourse because the money was obtained through an illegal transaction. to make matters worse, sellers are socially ostracized.228 one moldovan kidney seller says kidney sellers are treated worse than prostitutes.229 although organ sales are forbidden in virtually every nation, the illegal organ trade is booming. the primary organ purchasing countries include australia, canada, israel, japan, oman, saudi arabia and the united states.230 these illegal organ purchases result in poor health outcomes for both the buyer and seller.231 moreover, coercion is present at 221 id. 222 id. 223 id. at 78-79. 224 id. at 79. 225 organs for sale, supra note 207. 226 goodwin, supra note 139, at 188. 227 id. at 189. 228 moniruzzaman, supra note 209, at 78. 229 shafer & comstock cunningham, supra note 201. 230 yosuke shimazono, the state of the international organ trade: a provisional picture based on integration of available information, 85 bulletin of the world health organization 901-980 (2007), available at http://www.who.int/bulletin/volumes/85/12/06-039370/en/ [http://perma.cc/d86v-m5nu]. 231 id. http://dx.doi.org/10.2471/blt.06.039370 56 indiana health law review vol. 13:1 both ends of the transactions. sellers are generally penniless and ill informed about the risks of the procedure, and buyers are desperate to preserve their lives. despite the horrors of the black market and its universal condemnation, prosecutions for illegal organ sales are rare and difficult.232 israeli insurers reimbursed citizens for organ transplants performed anywhere in the world until 2008.233 still, israel does not punish organ buyers and sellers because it views these people as victims.234 instead, israeli law directs its wrath at the brokers and insurance companies that facilitate illegal organ operations.235 the united states has only recently convicted the first person under federal law of organ trafficking in 2011.236 the organ broker was released in under three years.237 though an immigrant, he was allowed to remain in the united states because his crime was not one of "moral turpitude."238 perhaps the medical community has reached the same conclusion because it 232 nancy scheper-hughes, human traffic: exposing the brutal organ trade, new internationalist magazine (may 1, 2014), http://newint.org/features/2014/05/01/organ-trafficking-keynote/ [http://perma.cc/33lz-2wzh]. 233 dimitri linde, israel, a leader in transplant tourism, finds a formula for increasing domestic donation, tablet (apr. 10, 2014), http://tabletmag.com/jewish-news-and-politics/164976/israel-organdonation [http://perma.cc/h48x-5hgw]. 234 asif efrat, combating the kidney commerce: civil society against organ trafficking in pakistan and israel, 53 brit. j. criminology 764, 777 (apr. 26, 2013), available at http://bjc.oxfordjournals.org/content/early/2013/04/22/bjc.azt025.full.pdf [http://perma.cc/qs55-7ajn]. 235 id. 236 brooklyn man pleads guilty in first ever federal conviction for brokering illegal kidney transplants for profit, fbi (oct. 27, 2011), http://www.fbi.gov/newark/press-releases/2011/brooklyn-man-pleadsguilty-in-first-ever-federal-conviction-for-brokering-illegal-kidneytransplants-for-profit [http://perma.cc/adt5-4qhk]. 237 david glovin, organ broker skirts expulsion after 'victimless' claim, bloomberg (dec. 23, 2014, 7:39 pm), http:// www.bloomberg.com/news/articles/2014-12-24/organ-broker-skirtsexpulsion-after-victimless-claim [http://perma.cc/5dsb-jl4b]. 238 id. http://dx.doi.org/10.1093/bjc/azt025 2016 57 a market for human organs: an ethical solution to the organ shortage provides care to patients who illegally buy organs.239 this encourages people to enter the black market while it penalizes those who follow the law and wait in the organ queue. black market organ buyers and sellers do so because they have nowhere else to turn.240 punishing such people is tough. b. iranian kidney system iran's organ transplant system began as part of eurotransplant,241 a central registry that stores data from several european countries and uses a compatibility matching system to allocate organs. 242 however, the iranian revolution severed the country's relationship with eurotransplant.243 the iran-iraq war began soon after the revolution. these circumstances left iran isolated and economically impaired; hence, iran struggled to procure dialysis equipment.244 from 1980 through 1985, dialysis patients in need of transplants had to travel abroad for the transplant, and living related donors provided most of the kidneys.245 the iranian government funded the expensive surgery, and the increasing number of patients on the kidney transplant waiting list caused the iranian government to establish kidney transplant centers in 1985.246 the capacity to perform transplants inside iran was only half the battle. 239 fiore, supra note 203. 240 woan, supra note 122, at 428. 241 fry-revere, supra note 153, at 50. 242 welcome on the homepage of etrl, eurotransplant reference laboratory, http://etrl.eurotransplant.org/cms/index.php [http://perma.cc/r643-jxr3] (last visited nov. 6, 2015). 243 fry-revere, supra note 153, at 50. 244 ali nobakht haghighi & nasrollah ghahramani, living unrelated kidney donor transplantation in iran, nature clinical practice nephrology (2006), http://www.nature.com/nrneph/ journal/v2/n12/full/ncpneph0364.html [http://perma.cc/6zjw-w2mq]. 245 ghods and savaj, supra note 9, at 1137. 246 id. http://dx.doi.org/10.1038/ncpneph0364 58 indiana health law review vol. 13:1 as is the case in every nation, the number of iranians in need of a kidney exceeded the supply of living related donors.247 a cadaver organ system was impractical in iran because iran lacked the infrastructure to preserve and transport organs.248 iranians also have a religious taboo against removing organs from the dead.249 thus, iran created "a government-funded, regulated, and -compensated living-unrelated donor renal transplantation program" in 1988.250 creating a kidney market was not iran's goal. the exchanges between kidney providers and recipients occurred naturally. iranian medical personnel simply overlooked the transactions because they did not want their patients to die.251 wanting the best for their patients, the iranian medical community hoped to regulate kidney exchanges.252 medical professionals were interested in screening donors and contract enforcement.253 individuals seeking to purchase a kidney sought to prevent would-be donors from taking a deposit then absconding from the contract as well as paying to screen individuals who fraudulently stated they were healthy enough to donate.254 interestingly, recipients believed the donors deserved higher levels of compensation than recipients were able to provide and wanted to provide donors with health insurance.255 although iran has a compensated donor program, physicians explain to patients the advantages of using a living related kidney donor over an unrelated donor.256 if the patient has no living related donor, or decides against using a living related donor, the patient is referred to a non 247 id. 248 fry-revere, supra note 153, at 50. 249 id. at 134. 250 ghods & savaj, supra note 9, at 1137. 251 fry-revere, supra note 153, at 50. 252 id. 253 id. 254 id. 255 id. at 50-51. 256 ghods & savaj, supra note 9, at 1137. 2016 59 a market for human organs: an ethical solution to the organ shortage governmental organization,257 called an anjoman, also referred to as dialysis and transplant patients associations (datpa). anjomans oversee iran's compensated living unrelated kidney donor program and help locate matching kidneys for patients.258 anjomans serve the same function as brokers do on the black market259 but are much more than benevolent kidney matchmakers.260 anjomans seem to genuinely care about their functions; accordingly, they assist patients medically and socially.261 anjomans attempt to make the donor's experience as positive as possible because a donor that is well taken care of will encourage future donations.262 to accomplish this goal, potential donors are screened by anjoman staff. potential donors are allowed to part with their kidney only if the anjoman believes participating in the transplant can benefit the donor.263 if the anjoman thinks the operation will retrogress a seller, the anjoman forbids the individual from donating her kidney.264 if a kidney provider is approved, anjomans ensure the donor is compensated.265 the desire to help displayed by anjomans is likely a consequence of their volunteer workforce composed of people who have participated in the transplant process.266 the iranian ministry of health began compensating donors in 1987-88, and the iranian parliament formally approved a payment of one million tomans in 1995 with the goal of eliminating price negotiations during kidney sales.267 however, inflation eroded the value of the toman, and the 257 id. 258 fry-revere, supra note 153, at 51. 259 ghods & savaj, supra note 9, at 1137. 260 fry-revere, supra note 153, at 51. 261 id. 262 id. 263 id. at 157. 264 id. at 140. 265 id. at 100. 266 haghighi & ghahramani, supra note 244. 267 id. at 83. 60 indiana health law review vol. 13:1 government did not increase the price.268 consequently, prices are now negotiated.269 kidney donors in 2009 received one million toman from the government plus an additional four to five million toman from the recipient on average.270 inflation makes comparing iranian and american currencies difficult,271 but the average iranian individual income was approximately $3,000 in 2009.272 the average price for a kidney during this period was approximately $5,000.273 when the recipient is poor and unable to afford a kidney, charities compensate the kidney provider.274 aside from donor compensation, other aspects of the transplant process are covered too. recipients of kidneys can purchase immunosuppressive drugs for a low price because the drugs are subsidized.275 charitable organizations provide immunosuppressive drugs for indigent transplant recipients.276 iranian kidney donors also receive one year of health care from the government,277 and in some regions of iran, health insurance for life.278 if male, donors are exempted from iran's mandatory military service.279 kidney recipients commonly give the kidney seller more than the negotiated price. additional compensation can be monetary but may also be in the form of food, clothing, or other goods.280 in nearly half of kidney transactions between living unrelated donors, the provider and recipient develop a mutual friendship.281 268 id. 269 id. 270 id. at 88. 271 id. at 22. 272 id. 273 id. 274 ghods and savaj, supra note 9, at 1138. 275 id. 276 id. 277 fry-revere, supra note 153, at 51. 278 id. at 156. 279 id. at 51. 280 id. at 92. 281 id. at 93. 2016 61 a market for human organs: an ethical solution to the organ shortage organ transplants in iran, despite appearances, are not commercial transactions.282 transplants are performed in government run hospitals at the government's expense.283 any valuable consideration exchanged between the organ provider and recipient is regarded as a token of appreciation.284 iranian law reasons a kidney saves the life of the recipient, and life is priceless.285 no amount of compensation can repay the donor for her sacrifice therefore, emoluments given to the donor are signs of gratitude.286 hence, organ transactions are mutual gifting rather than commercial sales under iranian law.287 under sharia law, agreements to exchange gifts are legally enforceable.288 the gratuitous nature of the transaction means iranians view those who sell their kidneys as "donors."289 to understand this view of the iranian kidney transplant system, the sociological conditions at the time of the system's establishment must be put in context.290 years of ruinous war with iraq had generated a spirit of sacrifice inside iran.291 this inspired the iranian living unrelated donor program where donors are compensated but still regarded as altruistic.292 iranian ayatollah mohaghegh damads asserts, "[t]he qu'ran looks favorably on those who help themselves 282 b. larijani et al., ethical and legal aspects of organ transplantation in iran, 36 transplantation proceedings 1241, 1242 (2004), available at http://ac.els-cdn.com/s0041134504005974/1-s2.0s0041134504005974-main.pdf?_tid=18e6a234-7834-11e5-bb1400000aacb35e&acdnat=1445460265_54a892f6601ca925fbf98821649a10 3d,. 283 id. 284 haghighi & ghahramani, supra note 244. 285 fry-revere, supra note 153, at 99. 286 id. 287 id. at 100. 288 id at 101. 289 haghighi & ghahramani, supra note 244. 290 id. 291 id. 292 id. http://dx.doi.org/10.1016/j.transproceed.2004.05.065 62 indiana health law review vol. 13:1 by helping others."293 thus, personal reward does not diminish the donor's sacrifice nor the good done by providing a kidney. the kidney provider saves a life, and the qu’ran states, "if any saves a life it is as if he saves the lives of all mankind."294 although these are the basics of the iranian system, anjomans operate slightly different in each region.295 in shiraz, using a compensated kidney donor is discouraged.296 donors and recipients are prohibited from "commercializing" the transaction beyond the government-guaranteed one million tomans.297 anjoman personnel in shiraz deny knowledge of recipients providing donors with additional compensation, and no amount agreed upon would be legally binding in shiraz.298 kermanshah's anjoman treat patients less hospitably than anjomans in other regions; nevertheless, kermanshah's anjoman manages to protect the interests of donors.299 iranians must donate in their home province.300 theoretically, an iranian could establish residence in another province if he had relatives there. the cost of travel and medical care related to the surgery, as well as the ability to access nonmedical benefits provided by the anjoman, render travel infeasible for most iranians.301 living unrelated donations are also restricted to individuals of the same nationality, and non-iranian citizens must pay for their own surgery.302 293 fry-revere, supra note 153, at 100. 294 e.x. surat i-maidah 5:32. 295 fry-revere, supra note 153, at 112. 296 id. at 57. 297 id. at 59. 298 id. 299 id. at 187. 300 id. at 60. 301 id. 302 id. at 19. 2016 63 a market for human organs: an ethical solution to the organ shortage vi. analysis and critique of iran's kidney system following this model, iran has not had a kidney waiting list since 1999.303 no other country has been able to eliminate its kidney waiting list.304 in fact, iran's kidney program has produced a surplus of willing kidney providers.305 although having a surplus of willing donors may appear to be a good situation, the number of iranians willing to part with their kidneys gives opponents of organ sales reason to question the iranian system. critics of the iranian system, and organ markets in general, note compensated iranian donors are usually poor, and donors are compelled by their social condition to sell their kidneys.306 a study of compensated iranian kidney donors found 6% of donors were illiterate, 24.4% had only an elementary education, and 63.3% had high school educations, while only 6.3% had attended college.307 the same study found 84% kidney providers were poor and 16% were middle class.308 wealthy iranians do not part with their kidneys for compensation. there are also reports of the screening process failing to catch financially desperate people.309 in the six months prior to the compensated kidney donation, the most 303 ghods & savaj, supra note 9, at 1137. 304 benjamin e. hippen, organ sales and moral travails: lessons from the living kidney vendor program in iran, 614 cato pol’y analysis 1, 4 (mar. 20, 2008), available at http://www.cato.org/sites/ cato.org/files/pubs/pdf/pa-614.pdf [http://perma.cc/8pvf-euhl]. 305 anne griffin, kidneys on demand, 334 brit. m. j. 502, 504 (mar. 10, 2007), available at http://www.ncbi.nlm.nih.gov/pmc/articles/ pmc1819484/pdf/bmj-334-7592-feat-00502.pdf [http://perma.cc/9wfe8alr]. 306 francis l. delmonico, the alternative iranian model of living renal transplantation, 82 kidney int’l. 625 (2012). 307 ghods & savaj, supra note 9, at 1140. 308 id. 309 b. broumand, living donors: the iran experience, 12 nephrology dialysis transplantation 1830, 1831 (1997), available at http:// ndt.oxfordjournals.org/content/12/9/1830.full.pdf [https://perma.cc/ f9hd-pk5f]. http://dx.doi.org/10.1136/bmj.39141.493148.94 http://dx.doi.org/10.1038/ki.2012.247 http://dx.doi.org/10.1093/ndt/12.9.1830 64 indiana health law review vol. 13:1 common life events experienced by donors were increased life expenses, low income, and household duties.310 these events were usually triggered by financial problems, losing one's job, and a family member's death.311 as a majority of compensated donors are poor and not well educated, concerns have been raised about the pretransplant screening process.312 there are reports of kidney providers being rushed through the donation process allowing providers with diseases such as hiv and tuberculosis to donate their kidneys.313 health is a concern after the operation as well because compensated donors showed poor health three months after the surgery.314 most compensated donors are not fully aware of the complications associated with living kidney donation and do not partake in follow up healthcare.315 psychological healthcare is an issue for compensated donors as 51% of compensated donors hated the person who received their kidney.316 three-quarters of kidney providers did not achieve their financial goals after the compensated donation,317 so depression may be a problem among compensated donors. compensated kidney donors also report being socially ostracized.318 additionally, the compensated living unrelated donor program is blamed for 310 ali-akbar nejatisafa et al., quality of life and life events of living unrelated kidney donors in iran: a multicenter study, 86 transplantation 937, 938 (2008), available at https:// www.researchgate.net/publication/23317754_quality_of_life_and_life_ events_of_living_unrelated_kidney_donors_in_iran_a_multicenter_st udy [https://perma.cc/5bz8-x9hw?type=source.] 311 id. 312 e.j. gordon & j.s. gill, where there is smoke there is fire: the iranian system of paid donation, 13 am. j. transplant 3063 (2013). 313 broumand, supra note 309, at 1831. 314 nejatisafa et al., supra note 310, at 940. 315 gordon & gill, supra note 312, at 3064. 316 javaad zargooshi, iranian kidney donors: motivations and relations with recipients, 165 j. urology 386-392 (2001). 317 id. 318 fry-revere, supra note 153, at 88. http://dx.doi.org/10.1097/tp.0b013e318186d945 http://dx.doi.org/10.1111/ajt.12486 http://dx.doi.org/10.1097/00005392-200102000-00008 2016 65 a market for human organs: an ethical solution to the organ shortage impeding the development of iran's cadaver donation program.319 most studies suggest the majority of compensated donors are poor, but some report the preponderance of compensated donors are middle class.320 regarding concerns about exploitation of the iranian poor, it is important to note that the majority of iranian kidney purchasers are poor.321 iranians would rather compensate a live donor and receive a kidney quickly than wait to accept a free kidney from a cadaver .322 if the poor are exploited by the iranian kidney market, afghan refugees in iran are prime candidates for exploitation as these afghans are among the earth's most impoverished people.323 there are no known cases of afghans participating in compensated donation of their kidneys with non-afghans.324 interestingly, approximately 80% of afghans who receive kidney transplants in iran use paid living unrelated donors.325 for this reason, iran's kidney system is credited with providing equal access to kidney care “regardless of gender and economic circumstances.”326 aside from eliminating the kidney waiting list, iran's system has greatly reduced the presence of coercion in kidney transactions.327 the regulated infrastructure prevents the horrors of the black market.328 brokers have incentives to deceive both the patient and organ provider because a 319 gordon & gill, supra note 312, at 3064. 320 fry-revere, what can iran teach us about the kidney shortage?, supra note 7. 321 ghods & savaj, supra note 9, at 1140. 322 fry-revere, supra note 153, at 132-33. 323 ghods & savaj, supra, note 9, at 1141. 324 id. 325 id. 326 behzad einollahi et al., deceased-donor kidney transplantation in iran; trends, barriers, and opportunities, 4 j. med. ethics 70 (2007) available at http://ijme.in/index.php/ijme/article/view/536/1396 [https:// perma.cc/z3q2-8kk8]. 327 id. 328 haghighi & ghahraman, supra note 244. 66 indiana health law review vol. 13:1 broker's payment hinges on the deal going through.329 plus, buyers and sellers have no legal recourse against organ brokers. brokers are not necessary in iran because compensated donors choose to present themselves for the kidney transaction.330 iran's kidney system is governed by nonprofit entities that are staffed by volunteers, so these institutions have no incentive to disenfranchise donors or recipients.331 therefore, providing a legal framework to compensate kidney donors has prevented the exploitation associated with sales on the black market.332 financial coercion is often cited as the reason for preventing organ sales; nevertheless, there are other forms of coercion. family pressure can be even more daunting than financial pressure, and the iranian kidney system prevents familial coercion to donate an organ.333 iranian males must serve in the military.334 however, men can be exempted for medical reasons, to care for elderly relatives, and to pursue an education.335 the iranian parliament considered a proposal allowing men to purchase an exemption, but this proposal was shutdown as discriminatory against the indigent.336 donating a kidney enables men to avoid conscription;337 thus, the ability to choose whether to donate a kidney reduces the government's coercive power over iranian men. although the health of compensated donors was worse three months after the donation than prior to the donation, the health of iranian donors made a full recovery by the end 329 hippen, supra note 304, at 4. 330 id. at 7. 331 id. at 4. 332 haghighi & ghahramani, supra note 244. 333 larijani, supra note 282, at 1242. 334 iran's new military policy could boost birthrates, al-monitor (oct. 12, 2014), http://www.al-monitor.com/pulse/originals/2014/10/iranmilitary-conscription-service.html# [https://perma.cc/4ssh-kgbc]. 335 id. 336 id. 337 fry-revere, supra note 153 at 51. 2016 67 a market for human organs: an ethical solution to the organ shortage of the year.338 the criticism leveled at iran for not following kidney providers post operation is a consequence of limited resources.339 compensated donors often live far from the transplant center and are unable or uninterested in journeying back to the medical facility for a checkup.340 of the donors that were followed, a majority of compensated donors were satisfied with the transaction and suffered no serious health problems.341 the social stigma mentioned by some kidney providers is likely an outcome of compensated donors being perceived as unable to earn money through more conventional methods.342 the account cited supra stating compensated donors are displeased with having donated their kidney was from a sample of 100 iranians taken over 20 years ago.343 moreover, the study was performed in one province, kermanshah.344 dr. sigrid fry-revere's 2008-2009 study examined multiple regions, and she had the lowest regard for the system in kermanshah.345 accounts that blame iran's living donor program for the country's low cadaver donor rate are similarly flawed as each region of the country acts differently. shiraz has been acknowledged by critics of the iranian kidney system as "exemplary" in procuring and performing cadaver transplants.346 since iran legalized 338 nejatisafa et al., supra note 310, at 940. 339 ghods, supra note 10, at 226. 340 id. 341 heidary rouchi et al., compensated living kidney donation in iran: donor's attitude and short-term follow-up, 3 iranian j. of kidney diseases 34, 34-39 (2009), available at http:// applications.emro.who.int/imemrf/ijkd_2009_3_1_34.pdf. 342 fry-revere, supra note 153, at 89. 343 zargooshi supra note 316. 344 id. 345 id. at 178. 346 delmonico supra note 306, at 626. 68 indiana health law review vol. 13:1 cadaver donation in 2000, iran has proceeded with cadaver donation much like other nations.347 iran's kidney system is not perfect. no agency monitors the long-term outcome of kidney donations in iran,348 so conclusions about the system are made with limited information. likewise, physical and mental health services should be provided to kidney providers long after the transaction.349 the iranian system has not completely eliminated the black market either.350 the government payment system has not kept pace with the cost of living, and this has caused would-be recipients and donors to negotiate a price—the very thing the government payment was supposed to prevent.351 nevertheless, iran has eliminated its kidney waiting list. a feat that has yet to be replicated. iran is not a free country.352 the iranian government is a tyranny.353 iran is not an adherent of laissez-faire economics. on the contrary, iran's economy is one of the world's most restricted, ranked 171 out of 178.354 this aversion to freedom has not prevented iran from using market based incentives as a solution to the kidney shortage. other countries should take note. 347 mitra mahdavi-mazdeh et al., renal replacement therapy in iran, 4 urol. j. 66, 67 (2007), available at http://www.sid.ir/en/ vewssid/j_pdf/83020070203.pdf. [http://perma.cc/kwf6-2kyh]. 348 bobak zonnoor, how to sell your kidney: a brief overview of the iranian model for kidney transplantation, in-training (mar. 21, 2014), in-training.org/sell-kidney-brief-overview-iranian-model-kidneytransplantation-5682 [http://perma.cc/4bcc-8n6m]. 349 nejatisafa et al., supra note 310, at 940. 350 zonnoor, supra note 348. 351 fry-revere, supra note 153, at 83. 352 iran, freedom house (2015), https://freedomhouse.org/report/ freedom-world/2015/iran#.vqiww47f8uc [https://perma.cc/we8uvn8d]. 353 behrooz behubudi, iran: 35 years of religious tyranny, the middle east http://www.themiddleeastmagazine.com/wp-mideastmaglive/2014/02/iran-35-years-of-religious-tyranny/ [http://perma.cc/gk2ybuzw] (last visited jan. 2, 2016). 354 country rankings, 2016 index of economic freedom, http://www.heritage.org/index/ranking [https://perma.cc/hm6e-ey66]. 2016 69 a market for human organs: an ethical solution to the organ shortage vii. an organ market in the united states this section sets forth two organ markets. one is a market for live organs, and the other is a cadaver market for all organs. in the live market, kidneys are the focus. this is because kidney extraction is relatively simple compared to other organ extractions but also because kidneys are the organ most in demand. the cadaver market will be for all organs because there is less risk of harm when extracting organs from cadavers. a. live organ market there is only one system where compensating organ providers is legal. accordingly, the best organ purchasing mechanism system is unknown. this does not mean implementing a market for organs is a step into totally foreign terrain. on the contrary, the market for organs could operate just like the current united states' transplant system. organ procurement organizations operate very similar to iranian anjomans.355 unos can act as a monopsony, and a monopsony is the only ethically plausible system for an organ market.356 turning unos into a monopsony allows unos to distribute organs just as it currently does. the method used to pair organ providers and recipients is unaffected by whether the organ is purchased or donated. the same holds true for the medical process. transplant teams will not alter their technique based upon the reason the organ has become available. most aspects of the transplant system will remain the same once payment for organs is allowed, but determining the price and the best method of distributing compensation to organ providers is a task that will require study. experimentation with various aspects of the market should 355 hippen, supra note 304, at 9. 356 beard et al., supra note 71, at 194. 70 indiana health law review vol. 13:1 be allowed to occur.357 a federalist approach to the organ market is well suited for such experimentation. as justice louis brandeis noted, “it is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.”358 allowing states to design their own systems enables the states to account for their own unique populations, cultures, and geographies.359 plus, permitting diverse compensation systems provides empirical data on whether compensation can increase the organ supply, and if so, what is the best method of providing compensation to organ providers.360 although a federalist approach is suggested, the federal government should set certain guidelines for states. the organs will be purchased through a federal monopsony, so the federal government should set the price for organs. the federal amount will serve as the price floor, but states may choose to provide additional compensation to organ providers. such compensation can be in the form of tax breaks, vouchers, employment preferences, or other means the state deems legitimate. calculating organ prices is difficult because organ sales are prohibited virtually everywhere. nevertheless, various methods have been proposed to measure the value of organs. one way to value organs is using tort judgments. tort awards are not appropriate for accessing the price of organs during a sale because the purpose of tort is “making the plaintiff 357 hippen, supra note 304, at 11. 358 new state ice co. v. liebmann, 285 u.s. 262, 311 (1932). (brandeis, j., dissenting). 359 michele goodwin, rethinking federal organ transplantation policy: incentives best implemented by state governments, in when altruism isn't enough: the case for compensating kidney donors 111, 121 (sally satel ed., 2008), available at http://www.aei.org/wpcontent/uploads/2014/07/-when-altruism-isnt-enough_161836373082.pdf [http://perma.cc/rq38-vawb]. 360 id. 2016 71 a market for human organs: an ethical solution to the organ shortage whole.”361 in organ sales, the recipient is being made whole, not the seller. hence, tort awards are not a proper fit to gauge the market price of a kidney. the other means of assessing an organ price is to use information from the available markets. on the black market, organ prices vary widely.362 this is due in part to transactions occurring around the globe and in many currencies. in united states dollars, kidneys have been sold for as little as $650363 and bought for as much as $300,000.364 iran probably provides the best measure of kidney price. the average kidney "price" in iran is approximately twice the mean iranian income when the government, anjoman, and recipient payments are summed.365 in 2013, the united states average per capita income was $28,155.366 accordingly, valuing a kidney at roughly $50,000 seems like a reasonable rate of compensation for an american kidney. this does not mean all kidneys must be sold for the same price though as certain kidneys may be more desirable than others.367 a formula that considers factors such as the 361 jill wieber lens, honest confusion: the purpose of compensatory damages in tort and fraudulent misrepresentation, 59 kan. l. rev. 231, 235 (2010), available at https://law.ku.edu/ sites/law.drupal.ku.edu/files/docs/law_review/v59/02-lens_final.pdf [https://perma.cc/bs2k-k28m]. 362 organ trafficking prices and kidney transplant sales, havocscope, http://www.havocscope.com/black-market-prices/organskidneys/ [https://perma.cc/bc46-6j8j] (last visited feb. 4, 2016). 363 gitonga njeru, kenya: sex-trafficked women and girls also vulnerable to organ trafficking, women news network (sep. 13, 2011), http://womennewsnetwork.net/2011/09/13/kenya-women-girls-organtraffickin/ [http://perma.cc/y4fh-2v6l] (last visited oct. 22, 2015). 364 jason gale & quah chin chin, singapore tycoon to be jailed in cash-for-kidney case, bloomberg (sep. 3, 2008) http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a0vvbzm2 uvzg&refer=asia [http://perma.cc/q683-tvya]. 365 fry-revere, supra note 153, at 220. 366 state & county quickfacts, u.s. census bureau, http://quickfacts.census.gov/qfd/states/00000.html (last updated sept. 30, 2015) [http://perma.cc/u27c-fbm3]. 367 beard et al., supra note 71, at 196. 72 indiana health law review vol. 13:1 seller's age, rarity of blood type, and family medical history would be fair to include in kidney valuation. thus, the price floor for kidneys should be set at a minimum of $50,000. distributing money to sellers presents challenges too. there are two issues to consider in disbursing the funds. one is whether to provide a lump sum or periodic payments. the other issue is whether to provide the payment immediately or defer the payment. states will have the option to choose how to allot the funds and can select one or more methods. below, the four ways to approach the two issues are presented with their potential pros and cons. 1.) immediate lump sum payment: providing sellers with the full price of their kidney upfront probably provides the most powerful incentive for an individual to sell her kidney. the lump sum option enables sellers to improve their lives substantially and quickly. putting $50,000 towards paying off debt, starting a business, or other use can have a sudden and dramatic positive impact on the seller's life. contrarily, placing all of the money in the seller's hands at one time means there is a chance the money can disappear immediately. people who suddenly receive large sums of money at once, such as lottery winners, often squander it.368 organ vendors going into financial ruin soon after the operation is bad for the individual, and the purpose of legalizing the market is to improve the lives of both the organ recipient and provider. plus, news of organ sellers worsening their lives by vending their organs will discourage future sales. the purpose of the market is to increase the supply of organs; hence, it is imperative that sellers have positive experiences. 2.) immediate periodic payments: providing sellers with small periodic payments immediately after selling should minimize the odds of whimsical spending. this reduces the odds of sellers ending up in a worse financial position than 368 the associated press, 'i had to adapt to this new life:' as powerball drawing nears, former lottery winners say hitting the jackpot comes at a price, n.y daily news (nov. 28, 2012) http://www.nydailynews.com/news/national/mega-lottery-winnerssound-advice-article-1.1209336?locallinksenabled=false [http:// perma.cc/xga4-6zts]. 2016 73 a market for human organs: an ethical solution to the organ shortage they were before the sale. it also provides a steady stream of income, even if the payments are only a few hundred dollars per month. stretching the payments can make the money last longer as the amount will collect interest. the downside of periodic payments is the incentive may not be as powerful as the lump sum payment because the periodic payments do not have the instant effect that the lump sum does. accordingly, periodic payments may not result in as many sales as lump sum payments, at least in the short run. 3.) deferred lump sum payment: deferring the payment virtually eliminates the possibility of duress playing a role in the transaction because the seller will receive no immediate benefit from the sale. interest is also accruing on the payment while the sum remains in the bank. however, as the interval between the organ extraction and the payment increases, the number of people interested in selling their organs may decrease. the pain and risks of the operation are instantaneous, so deferring payment may lead people to assume the risk is not worth the reward. on the other hand, people who choose to undergo the procedure for a delayed benefit are more likely to have a plan for how they will use the proceeds of the sale. presumably, such individuals are more likely to use the money prudently than they are to spend it on frolics. 4.) deferred periodic payments: deferred periodic payments operate very much like a pension and could feasibly be fused with a retirement package. the danger of placing payments for an organ in a retirement fund is the retirement fund could go broke. it would be tragic if organ providers exchanged their organs for a sum of money they will never see. for this reason, deferred periodic payments may not be attractive to potential sellers. nevertheless, this option may be appealing to some. knowing a sum of money is guaranteed regardless of how the stock market or their retirement fund performs could be attractive. plus, the sum is generating interest payments during the deferment. regardless of how the states choose to distribute the money, the federal government should ensure states meet certain criteria. the purpose of these criteria is to protect the financial and physical wellbeing of vendors. six safeguards are listed below. 74 indiana health law review vol. 13:1 1.) the live organ market should be limited to kidneys initially. this is because kidney extraction is the safest of the organ extractions,369 and this fact will presumably make a kidney market more palatable to opponents of organ sales. kidneys are also the organs most in demand. eliminating the kidney shortage erases roughly 100,000 names from the organ queue. if the kidney market proves successful, then expanding the market to include other organs will make sense. 2.) organ providers post operative living expenses should be covered. although sellers are compensated for the transaction, providing an organ for transplant currently cost donors an average of $5,000.370 this cost should be made clear to sellers, so they know to subtract $5,000 from the purchase price. health insurers nor the government need necessarily be responsible for the post operative care. charities will likely assist organ providers, both sellers and donors, once doing so is legal.371 currently, the alodf attempts to allay the burden on donors by providing financial support.372 alodf is operating in a legal gray area. if the law clearly allowed organ providers to receive "valuable consideration," one assumes more assistance would be available to donors. 3.) health insurance should be provided to all organ providers. the organ provider is undergoing a risk for the 369 katrina a. bramstedt, living liver donor mortality: where do we stand?, 101 am. j. gastroenterology 1, 4 (2006), available at http://www.clevelandclinic.org/bioethics/documents/liverdonormortalit y.pdf [http://perma.cc/h72d-vc4t]. 370 am. transplant found. & lisa shankar, understanding the barriers to living donation, am. transplant found. http://www.americantransplantfoundation.org/programs/ mentorshipprogram-2/mentor/living-donor-connectors/understanding-the-barriersto-living-donation/ [http://perma.cc/yws3-7jfw] (last visited oct. 22, 2015). 371 hippen, supra note 304, at 9. 372 mission, am. living organ donor fund, http:// www.helplivingdonorssavelives.org/about-us/our-mission/ [http:// perma.cc/cg47-42u3] (last visited oct. 22, 2015). http://dx.doi.org/10.1111/j.1572-0241.2006.00421.x 2016 75 a market for human organs: an ethical solution to the organ shortage purpose of saving a life. protecting the organ provider's health is a logical way to compensate the provider for the risk. health insurance should be provided to donors as well as sellers. congressional republicans continue attempting to repeal the aca,373 but regardless of whether they ever succeed, healthcare can be offered to organ providers through government exchanges, medicaid, medicare, or a fully refundable health insurance tax credit. even the libertarian cato institute is open to providing organ sellers and donors with healthcare.374 4.) minimum organ seller-screening criteria should be established. a goal of legalizing the organ market is to reduce exploitation of the poor and incompetent. setting forth a minimum waiting period prior to selling a kidney reduces the likelihood of a duress-induced sale. similarly, psychological testing should occur to ensure the seller is competent and is aware of the risks of the procedure. 5.) exempt kidneys and all organs, as well the proceeds of organ sales, from seizure. as preventing exploitation of sellers is a motivation for legalizing organ sales, prohibiting creditors from establishing claims to the organs of a debtor is imperative. similarly, creditors should be barred from claims against money received from organ sales. organ sellers have earned this money by sacrificing their bodies to save a life. creditors should not be able to collect money that was earned from organ sales because the purpose of the market is to encourage consensual life saving transactions. 6.) the market should be limited to americans. on the basis of practicality, accessing medical records of americans is easier than accessing the medical records of foreign citizens.375 the organ provider's medical history is highly germane to the transplant procedure. ensuring the organ provider receives adequate post-operative care and healthcare subsequently requires the organ seller to be an american domiciliary.376 restricting the market to americans decreases the likelihood of exploitation of citizens 373 fabian, supra note 87. 374 hippen, supra note 304, at 10. 375 beard et al., supra note 71, et al. at 204. 376 id. 76 indiana health law review vol. 13:1 from impoverished foreign nations though the screening process should detect and remove such people from the market. b. cadaver organ market becoming a cadaver organ seller can occur through the same channels one currently becomes an organ donor postmortem. the complicating factor is having the future organ seller allocate the payment after his death; however, this obstacle is easily overcome. the best solution would be having the seller allocate the money in a testament. in the absence of a written will, the money could be distributed via the laws of intestacy. a voucher for funeral expenses may also be an effective way of compensating organ providers, as demonstrated by spain.377 establishing a price for cadaver organs is complicated for the same reason as establishing a price for live organs: there are not many legal examples. one scholar suggested setting a cadaver price for each major organ at $864.27 in 2008,378 roughly $938, adjusting for inflation.379 although the sale of cadavers is illegal, firms charge to process and store cadavers.380 corpses can be procured for $10,000 and generate up to $200,000 from the tissues.381 therefore, a lump sum payment of $1,000 is a reasonable base rate for 377 see discussion of the spanish system supra. 378 lloyd r. cohen, directions for the disposition of my (and your) vital organs, regulation 33 (fall 2005), http://object.cato.org/ sites/cato.org/files/serials/files/regulation/2005/9/v28n3-1.pdf [http:// perma.cc/xxb2-tpya]. 379 cpi inflation calculator, bureau of labor statistics, http://www.bls.gov/data/inflation_calculator.htm [http://perma.cc/w65pqule] (last visited apr. 8, 2015). 380 kate wilson et al., skin, bones and tissue for sale: how the dead are being used for grisly trade in human body parts (july 18, 2012), http://www.dailymail.co.uk/news/article-2175006/skin-bones-tissue-salehow-dead-used-grisly-trade-human-body-parts [http://perma.cc/7ld4l5qh]. 381 id. 2016 77 a market for human organs: an ethical solution to the organ shortage each cadaver organ. the sum could be even higher as only about one percent of cadaver organs are transplantable. however, there may be bars on payment in some cases. the law should not create an incentive for people to pull the plug on their parents nor commit suicide as a means of bettering their family financially. keeping a brain-dead person alive already costs families, so money is already an issue in the equation. suicide is the more challenging issue, particularly in right to die states. viii.consequences of organ market the intended and presumable consequence of an organ market is an increase in the number and quality of organs available.382 the poor will likely have better access to organs, as evinced by the iranian example; thus, a legal organ market will provide more equitable health outcomes than the current system.383 more organs means less time waiting for the needed organ,384 and less time waiting for organs results in better health outcomes for the organ recipient.385 plus, the increased supply of organs should result in better matches for the recipient's body.386 a greater supply of organs means more transplants can be performed, so more lives will be saved. regarding kidney transplants, the procedure is highly preferable for most patients with end stage renal disease from both economic and health perspectives.387 gary becker 382 andrew v. scott & walter e. block, organ transplant: using the free market solves the problem, 2 j. clinic. res. bioethics 1, 2 (2011), available at http://omicsonline.org/organ-transplant-using-the-freemarket-solves-the-problem-2155-9627.1000111.pdf [http://perma.cc/ gw2x-2276]. 383 capaldi, supra note 158, at 12. 384 cash for kidneys, supra note 92. 385 introducing incentives, supra note 121, at 14-15 386 aziz, supra note 5, at 81. 387 alan langnas & daniel r. salomon, op-ed, remove disincentives to organ donation, the n.y. times (aug. 21, 2014), http:// http://dx.doi.org/10.4172/2155-9627.1000111 78 indiana health law review vol. 13:1 and julio elias write, “most of those on dialysis cannot work, and the annual cost of dialysis averages about $80,000. the total cost over the average 4.5-year waiting period before receiving a kidney transplant is $350,000, which is much larger than the $150,000 cost of the transplant itself.”388 the price of immunosuppressant drugs is much cheaper than dialysis,389 so even factoring drug expenditures, savings are accrued. lower doses of immunosuppressant drugs will be required with better organ matches resulting in further savings.390 providing dialysis patients with timely transplants could save the federal government $200,000 per year per patient.391 the total cost of kidney transplants may decrease as well because the market should reduce kidney procurement costs.392 additionally, the stress on patient families will be ameliorated. similar patient outcomes are expected for those in need of organs other than kidneys because a market for cadaver organs will increase the supply of all organs. aside from saving american lives, legalizing the organ market will damper the horrid happenings of the black market. legalization is the most effective way to destroy underground markets. there is nothing inherently evil involved in giving up a kidney for money. the malevolence associated with black market organ sales germinates in the darkness of the underworld. providing a legal framework www.nytimes.com/roomfordebate/2014/08/21/how-much-for-a-kidney/ remove-disincentives-to-organ-donation [http://perma.cc/7zaa-xzlk]. 388 cash for kidneys, supra note 92. 389 mycophenolate mofetil prices, coupons and patient assistance programs, drugs.com (oct. 23, 2015) http://www.drugs.com/priceguide/mycophenolate-mofetil [http://perma.cc/5298-megr] (showing that mycopheonlate mofetil tablets cost $122.44 for 100 capsules at 500mg). 390 brochure, from me to you—so your relative needs a kidney, renal resource centre, (apr. 8, 2015), http://www.renalresource.com/ brochures/syrnak.php [http://perma.cc/9dv5-e53j]. 391 fry-revere, supra note 153, at 206. 392 cash for kidneys, supra note 92; introducing incentives, supra note 121, at 12. 2016 79 a market for human organs: an ethical solution to the organ shortage offers protection to buyers and sellers. both parties are fully informed of the risks of the operation, and both parties can use the law in their favor. sellers will be ensured they receive their wage. if they do not, the courts offer a legitimate mechanism for righting wrongs occurring during the process. organ recipients have no need to worry about the quality of their surgeon or the organ's quality as proper medical protocol governs the transplant in legal operations. those on transplant waiting lists will have less incentive to explore illegal organ procurement options because more legal organs will be available. likewise, desperate and incompetent people are shielded from exploitation in a legal market. a potential ancillary benefit of legalizing the organ market is improved public health.393 most transplants arise from preventable, obesity related conditions such as type 2 diabetes and hypertension. if only non-obese individuals are allowed to sell their organs, people have an additional reason to control their weight. even people who have no intentions of selling a kidney while alive may be interested in selling their organs postmortem. this incentive does not intrude into peoples' lives and is in no way paternalistic. it simply provides a potential reward for a healthy lifestyle. an improved level of public health would reduce the number of transplants needed. ix.conclusion the american and international organ procurement laws are not designed to increase organ supply; instead, the legal framework hopes to prevent commodification of the body.394 this may be a worthy goal, but it does not save lives. thousands of people waste away on dialysis each year due to the kidney shortage. an unknown number of others forego the wait and take their chances on the black market. unfortunately, this desperate attempt to save their own lives often results in the exploitation of the indigent. 393 scott & block, supra note 382, at 2. 394 mayes, supra note 13, at 2. 80 indiana health law review vol. 13:1 there are two hopes for alleviating the organ shortage. technology holds tremendous promise, but thousands of lives will be lost before technology offers a remedy to the organ shortage. these deaths are unnecessary because there are viable organs available for transplant. however, the owners of these organs lack incentives to part with their organs. altruism, the engine of the current organ procurement model, simply is not enough.395 therefore, a market based approach should be applied to the organ shortage. though some oppose markets, legalizing the organ trade best addresses market opponents concerns. a legal framework protects sellers from the wretched, exploitive practices that are commonplace on the black market. recipients and sellers both receive better care when the procedure is legal because the law offers them quality assurances. furthermore, equitable access to transplants is better ensured under a legal organ market. the same exact organ distribution procedures that are in place at present can continue even if monetary incentives are involved. some may fear creating a market for organs allows humans to buy more life; that is, those with means can keep purchasing replacement parts indefinitely. this concern is irrelevant to an organ market for a few reasons. first of all, a market for organs would simply make a widely accepted medical procedure–organ transplantation–more efficient. legalizing the organ trade does not open any new doors from a medical technology perspective. building off the first objection, the second objection is that it is theoretically possible for an individual to procure an unlimited supply of new body parts already. an individual can legally persuade people to donate their organs; thus, a patient in need of an organ with the oratory ability of clarence darrow may be able to convince multiple people to part with their organs. additionally, a person in need of a transplant with a large squadron of exceptionally generous friends can engage paired donations endlessly essentially enabling a person to obtain an infinite number of organ transplants via barter. a more 395 introducing incentives, supra note 121, at 22. 2016 81 a market for human organs: an ethical solution to the organ shortage likely scenario would be a supremely wealthy individual who keeps purchasing organ transplants on the black market. there are valid concerns about how far science should go in its efforts to save a life. at what point do efforts to preserve life begin to create a frankenstein? for example, should 3d printed organs be better than “natural” human organs? failure of the heart's left main artery causes heart attacks, so researchers are already trying to design hearts with two left main arteries making death by heart attack much less likely.396 genetic engineering presents similar issues and arguably raises more complex ethical challenges. doctors have tried transplanting animal organs into humans, known as xenotransplantation, for over 50 years.397 xenotransplants originally achieved very limited success.398 however, genetic engineering has the potential to transform pig organs into a viable medical option for humans in need of organs.399 these issues are certainly worthy of discussion, but they have little relevance to a market for organs. a market is not a biomedical breakthrough. on the contrary, a market may be the most basic mechanism for allocating resources. only one country has eliminated its kidney shortage. unsurprisingly, this is the only country with a market style incentive for kidney providers. basic economics and experience demonstrate a market for organs can end the organ shortage. legalizing the trade in organs also happens to be the most ethical option at this time. it reduces suffering and death, respects individual autonomy, distributes organs in a socially desirable fashion, saves money, and helps end the maleficent underground organ trade. 396 john graber, report predicts possible ban on bioprinting by 2016, 3d printer world (feb. 14, 2014), www.3dprinterworld.com/ article/report-predicts-possible-ban-bioprinting-2016 [http://perma.cc/ ze85-zas7]. 397 shima benham manesh et al., ethical issues of transplanting organs from transgenic animals into human beings, 16 cell j. 353, 354 (aut. 2014), available at www.ncbi.nlm.nih.gov/pmc/articles/ pmc4204195/pdf/cell-j-16-353.pdf. [http://perma.cc/2lck-redf]. 398 id. 399 id. microsoft word 1-volume xii masthead.docx are bioequivalents really equal?: generic substitution in the context of mental illness jaymes v. fairfax-columbo and david dematteo∗ abstract generic drugs are significantly less expensive than their brand name counterparts, and the use of generic drugs has increased drastically in recent years, representing upwards of 75% of all prescriptions filled in the united states. a large amount of this increase is due to states’ adoptions of generic substitution laws, or laws that allow for the substitution of generic drug formulations in place of their brand name counterparts. theoretically, generic drugs are just as effective as their brand name alternatives; in fact, the fda requires that generic formulations demonstrate “bioequivalence,” meaning that they show absorption rates of active ingredients that are within a range of 80-125% of that of brand name drugs. despite their theoretical equivalence, generic and brand name drugs can produce disparate results and side effects. this is problematic when states employ substitution schemes in which no notification of either the physician or patient is necessary for the pharmacist to substitute, and is especially problematic when these conditions are met and substitution is mandated. this problem may be exacerbated for individuals with chronic mental illness, where reduced effectiveness of generic medications can produce individually and societally detrimental outcomes and where differential side effects might interfere with already poor medication compliance rates. this article examines the effectiveness of generic versus brand name drug formulations in terms of treating mental illness, discusses possible implications of their ∗* jaymes fairfax-columbo is a j.d./ph.d. student in the drexel university school of law and college of arts and sciences; jd expected 2019, phd expected 2020; b.a., swarthmore college. david dematteo, j.d., ph.d., is an associate professor of psychology and law at drexel university, where he is also director of the j.d./ph.d. program in law and psychology. http://dx.doi.org/10.18060/18964 282 indiana health law review vol. 12:1 differential effectiveness, and proposes several solutions for policy change to combat these issues. i. introduction .................................................................. 283 ii. generic drugs and substitution: definition, standards, and approaches ............................................ 287 a. generic drugs: what are they? ................................. 287 b. state approaches to generic substitution ................. 288 iii. scientific issues with generic substitution ........ 290 a. the limits of pharmacokinetic studies ..................... 290 b. bioequivalence: do generic drugs really produce the same effects as brand names? ...................................... 293 iv. generic substitution and mental illness ............. 295 a. how effective are generics at treating mental illness? ............................................................................. 296 1. bipolar disorders ...................................................... 296 2. anxiety disorders ..................................................... 299 3. major depressive disorder ....................................... 302 4. schizophrenia and psychotic disorders ................... 304 b. benefits and detriments of generic substitution of medications for consumers ............................................. 306 c. why should we care? ................................................ 307 1. mental health disorders as chronic disorders ...... 308 2. medication adherence .............................................. 309 3. patient autonomy: the right to medical decision making .......................................................................... 310 4. seemingly overlooked problems: criminal culpability and pharmacist liability .......................... 316 5. limitation of remedies for persons injured by generic psychotropics and competitor liability ........ 319 v. what should we do? ................................................... 322 a. eliminate mandatory generic substitution .............. 322 b. notification and consent ............................................ 322 c. education..................................................................... 323 d. at the very least, employ the above proposals for psychotropic drugs .......................................................... 323 vi. conclusion .................................................................. 324 2015 are bioequivalents really equal? 283 i. introduction in march 2008, andrew richards was sitting in front of his television when he collapsed suddenly, stating that he felt as if he had been hit with a bolt of lightning.1 while richards was indeed felled by electricity, it did not come in the form of lightning; rather, it came in the form of abnormal electrical activity in his brain—in other words, a seizure.2 richards, who suffers from depressive symptoms, contends that his seizure was the result of generic substitution, or the process of his pharmacist switching him from a 300 milligram (mg) prescription of wellbutrin xl, a brand name antidepressant, to a generic version of the drug manufactured by teva pharmaceuticals usa.3 richards indicated that immediately following the switch he began to experience “jolts and jerks,” and that while he and teva came to a settlement in the civil suit that followed his seizure, he still experiences spasms and other lingering effects associated with the episode.4 while richards’ “jolts and jerks” may have been warning signs of an impending seizure, in reality warning signs regarding the potential deleterious effects of teva’s generic had existed for over a year prior to his attack.5 in 1 charles seife & rob garver, no substitute: when a generic drug isn’t what it seems, propublica (apr. 15, 2013, 8:17 am), http://www.propublica.org/article/no-substitute-when-a-generic-drugisnt-what-it-seems, archived at http://perma.cc/va6y-wwt5. 2 id. seizures are caused by abnormal electrical activity in the brain, either on one side of the brain (focal seizure), or on both sides (generalized seizure). u.s. nat’l inst. of health, seizures, nlm/nih, http://www.nlm.nih.gov/medlineplus/seizures.html (last visited mar. 19, 2015). 3 seife & garver, supra note 1. generic substitution is the process by which a generic drug is substituted for a prescribed brand name drug; both the generic drug and the brand name drug have the same active ingredient. john posner & john p. griffin, generic substitution, 72 brit. j. clinical pharmacology 731, 731 (2011). it is possible to switch from one form of a generic medication to another, particularly when patients switch to a pharmacy with a different generic supplier than their previous pharmacy. paul e. greenberg, does generic substitution always make sense?, 11 j. med. econ. 547, 548-49 (2008). 4 seife & garver, supra note 1. 5 id. http://dx.doi.org/10.1111/j.1365-2125.2011.03920.x http://dx.doi.org/10.3111/13696990802371075 284 indiana health law review vol. 12:1 december 2006, the united states food and drug administration (fda) approved the first generic versions of wellbutrin xl.6 the generic came in two strengths, 150 mg and 300 mg.7 within weeks of the release, consumer complaints about diminished effectiveness and negative side effects started pouring in.8 initially, the fda brushed off the complaints, stating its belief that the drugs were equivalent and turning the perceived disparity back on the consumer, indicating that perhaps the consumers’ mental illness was the root of the perceived difference, not the actual effectiveness of the drug itself.9 though the fda gave the 300 mg generic its endorsement, skepticism over the drug’s “equivalence” did not subside.10 alarmed at the sheer number of complaints he was receiving about the generic, people’s pharmacy founder joe graedon reached out to independent testing group consumer lab and asked it to evaluate the equivalence of the generic to wellbutrin xl 300 mg.11 consumer lab’s results indicated that while the active ingredient in the two drugs was identical, the rate at which the ingredient was released differed tremendously.12 within two hours the generic had released 34% of the active ingredient compared to 8% for its brand name counterpart, and within four hours the generic had released almost 50% 6 angel reyes iii, generic wellbutrin xl antidepressant recall, reyes l. blog (jul. 02, 2013), http://reyeslaw.com/blog/genericwellbutrin-xl-antidepressant-recall/, archived at http://perma.cc/xy6xlk7e. 7 id. 8 id. for an example of complaints, see joe graedon & terry graedon, side effects of generic wellbutrin, the people’s pharmacy (apr. 23, 2007), http://www.peoplespharmacy.com/2007/04/23/sideeffects-of/, archived at http://perma.cc/exx7-xsnw. 9 david maris, a drug recall that should frighten us all about the fda, forbes (oct. 10, 2012, 3:00 pm), http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-toserious-problems-at-the-fda/, archived at http://perma.cc/2k68-ml9n. 10 liz neporent, fda asks for voluntary recall of popular generic antidepressant, abc news (oct. 4, 2012), http://abcnews.go.com/health/fda-finds-generic-antidepressantoriginal/story?id=17399399, archived at http://perma.cc/bp2h-kw5v. 11 id. (people’s pharmacy is a popular consumer advocacy group.) 12 id. 2015 are bioequivalents really equal? 285 of the active ingredient versus just 25% for wellbutrin xl.13 in effect, the generic functioned more like an immediaterelease drug as opposed to the extended-release product it was advertised to be.14 armed with these findings, graedon confronted the fda, requesting the generic’s bioequivalence testing data.15 unfortunately, the fda could provide no such information; in fact, it informed graedon that the only bioequivalence testing that generic wellbutrin xl had been subjected to was on its 150 mg dose—the fda had merely extrapolated those results to the 300 mg dose and assumed it was also bioequivalent.16 subsequent to this admission, the fda commissioned a bioequivalence study for the 300 mg dose.17 results were not encouraging, and indicated that compared to the extended-release wellbutrin xl 300 mg, the generic did not deliver the active ingredient at the same rate and to the same extent to be considered bioequivalent.18 on october 3, 2012, approximately five years after the initial complaints started rolling in, the fda issued a press release stating that wellbutrin xl 300 mg and teva’s generic version were not therapeutically equivalent.19 the 13 id. 14 id. 15 id. 16 bob pollock, back in the headlines—fda updates bioequivalence of buproprion extended-release 300mg tables, lachman consultants (oct. 11, 2013), http://www.lachmanconsultants.com/back-in-the-headlines-fda-updatesbioequivalence-of-bupropion-extended-release-300mg-tablets.asp, archived at http://perma.cc/thg4-envs. 17 neporent, supra note 10. 18 questions and answers regarding market withdrawal of budeprion xl 300 mg manufactured by impax and marketed by teva, u.s. food and drug admin., http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinf ormationforpatientsandproviders/ucm322160.htm#q8, archived at http://perma.cc/2jgl-yft8 (last updated oct. 3, 2012). 19 fda update: budeprion xl 300 mg not therapeutically equivalent to wellbutrin xl 300 mg, u.s. food & drug admin. (oct. 10, 2013), http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformatio nforpatientsandproviders/ucm322161.htm, archived at http://perma.cc/57kf-lwbq. as of october 10, 2013, the fda, having 286 indiana health law review vol. 12:1 fda then retracted its approval of the generic, prompting teva to voluntarily withdraw the drug from the market.20 the above example is an extreme case—theoretically, bioequivalence testing before generic drugs enter the market should weed out future similar cases. however, the underlying message is the same: just because drugs feature the same and similar amounts of an active ingredient, it is not necessarily ensured that the drugs will perform equivalently. this article argues that, in general, and at least as regards psychotropic medications, or medications designed to treat and manage the symptoms of mental health disorders, generic substitution schemes that do not provide for notification or consent of either patients or their doctors are misguided. part ii provides an overview of generic substitution and outlines the different ways that states approach it. part iii discusses scientific issues with generic substitution, exploring the limits of pharmacokinetic studies and the theory of bioequivalence. part iv examines the efficacy and effectiveness21 in treating four major categories of mental illness, considers the benefits and detriments of generic substitution for consumers, and discusses treatment and legal issues that are particular to substituting psychotropic medications. lastly, part v proffers several solutions for policy change asked pharmaceutical companies producing generic versions of wellbutrin xl 300mg to carry out bioequivalence studies, has determined that three of the four producers, actavis, inc., mylan, inc., and par pharmaceuticals satisfied bioequivalence standards but one, watson, did not. as a result, watson has withdrawn its product from the market. see update: bupropion hydrochloride extended-release 300 mg bioequivalence studies, u.s. food & drug admin. (oct. 10, 2013), http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationfor patientsandproviders/ucm322161.htm, archived at http://perma.cc/73uljuug. 20 fda update: budeprion xl 300 mg not therapeutically equivalent to wellbutrin xl 300 mg, supra note 19. 21 “efficacy” refers to the performance of an intervention (here, medication) under controlled and ideal circumstances, whereas “effectiveness” refers to the performance of a medication under “real world” conditions. amit. g. singal, a primer on effectiveness and efficacy trials, 5 clinical translational gastroenterology 1, 1 (2014). http://dx.doi.org/10.1038/ctg.2013.13 2015 are bioequivalents really equal? 287 designed to help mitigate the various concerns outlined in the rest of the article, including eliminating mandatory substitution, eliminating substitution without consent, and providing education to allow consumers to make informed decisions about opting for generic medications. ii. generic drugs and substitution: definition, standards, and approaches a. generic drugs: what are they? generic drugs are lower-cost drug alternatives that contain the same active ingredients as their brand name counterparts, but vary in terms of other characteristics, such as drug name, appearance (size, shape, color, etc.), and inactive ingredient makeup.22 generic drugs are regulated by the fda, and must fulfill several requirements as compared to brand name drugs to obtain approval: 1) they must contain the same active ingredients; 2) they must be identical in strength, dosage, form, and route of administration; 3) they must be manufactured according to fda standards for branded drugs; 4) they must have the same intended use; 5) they must meet the same batch requirements for identity, strength, purity, and quality; and 6) they must be “bioequivalent.”23 this article is chiefly concerned with the last requirement. generic drugs must be “bioequivalent” to their brand name counterparts, meaning that they must show similar bioavailability, defined as “the rate of and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action” 22 depression & bipolar support alliance, generic and brand name drugs: understanding the basics 4 (2007), available at http://www.dbsalliance.org/pdfs/genericrx.pdf. 23 what are generic drugs?, u.s. food & drug admin., http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusin gmedicinesafely/understandinggenericdrugs/ucm144456.htm, archived at http://perma.cc/59xm-gvfs (last updated may 12, 2009). 288 indiana health law review vol. 12:1 under experimental conditions.24 the concept of bioequivalence is premised on the assumption that if two drugs have similar concentrations and absorption rates in terms of their shared active ingredient, they will be “similarly safe and effective.”25 a generic is considered to be bioequivalent when bioavailability ranges between 80%125% of the brand-name reference drug with 90% confidence, meaning there is a reasonable certainty that at least 90% of the time the average bioavailability of the generic drug will fall within that range.26 further, bioequivalent drugs exist in two types: pharmaceutical equivalents and pharmaceutical alternatives.27 b. state approaches to generic substitution states consider six factors in formulating their generic substitution laws: 1) whether to require pharmacists to utilize the orange book (an fda publication listing/providing guidelines for which generic medications are considered to be bioequivalent); 2) whether to mandate substitution; 3) whether to create a state drug formulary; 4) 24 jesse c. vivian, generic substitution laws, 33 u.s. pharmacist 30 (2008), available at http://www.uspharmacist.com/content/s/44/c /9787/, archived at http://perma.cc/q2k6-5eqp. 25 pierre blier & diane m. sloan, q & a: generic substitution for psychotropic drugs, 14 cns spectrums 1, 4 (2009), available at http://www.cnsspectrums.com/userdocs/0909cns_q_a_blier.pdf, archived at http://perma.cc/7n3h-9n3p. 26 jaime r. hornecker, generic drugs: history, approval process, and current challenges, 34 u.s. pharmacist 26, 26-30 (2009). in bioavailability trials, the fda is concerned with three things compared to the branded drug: the generic’s area under the curve (auc), cmax, and tmax. auc refers to the mean extent to which a drug’s active ingredient is absorbed by the body. cmax refers to the mean peak concentration that the active ingredient reaches in the body. tmax refers to the mean time it takes for an active ingredient to reach its cmax. scott gavura, generic drugs: are they equivalent?, science-based medicine (jan. 5, 2012), http://www.sciencebasedmedicine.org/genericdrugs-are-they-equivalent/, archived at http://perma.cc/2svl-pg93. 27 vivian, supra note 24. “pharmaceutical equivalents” are generic drugs as they were defined supra part ii(a). “pharmaceutical alternatives” are generic drugs that are “formulated with a different salt, ester, or complex.” id. 2015 are bioequivalents really equal? 289 whether to require consent from either the patient or a physician; 5) whether to require that a generic cost less than the brand name version; and 6) whether to recognize narrow therapeutic index (nti) drugs.28 a majority of states require pharmacist use of the orange book to substitute, but a sizable minority make no reference to the orange book in their substitution laws.29 concerning mandated substitution, the prevailing approach is for states to permissively allow for substitution at the pharmacist’s discretion or in accordance with other regulations, though a minority mandate substitution when a suitable generic is available.30 regarding consent, the 28 id. according to the fda, nti drugs are those “containing certain drug substances that are subject to therapeutic drug concentration and pharmacodynamic monitoring,” u.s. dept. of health and human serv. food and drug admin. ctr. for drug evaluation and research, guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediaterelease solid oral dosage forms based on a biopharmaceutics classification system 9 (2000). nti drugs are dangerous because the ranges at which these drugs produce therapeutic and toxic effects are close together, making it easy to cross one threshold into another. liang et al., illegal “no prescription” internet access to narrow therapeutic index drugs, 35 clinical therapeutics 694, 694 (2013). 29 vivian, supra note 24. 30 see id.; avalere health, llc., state policies regarding generic substitution, 2010 2 (2010); u.s. dep’t of health & human serv., aspe issue brief: expanding the use of generic drugs appendix a (2010). nearly all states allow for physicians to preemptively override substitution by marking prescriptions to be filled with the branded medication only. see avalere health, llc, supra, at 3; u.s. dep’t of health & human serv., supra, at appendix a. however, given the decreasing amount of time that doctors are spending with their patients, sometimes as little as eight minutes for newer doctors, it is unclear how often doctors and patients discuss preferences for brand name medications. see pauline w. chen, for new doctors, 8 minutes per patient, n.y. times well blog (may 30, 2013, 12:01 am), http://well.blogs.nytimes.com/2013/05/30/for-new-doctors-8-minutes-perpatient/?_php=true&_type=blogs&_r=0, archived at http://perma.cc/8yql-5w87; danielle ofri, the doctor will see your electronic medical record now, slate future tense blog (aug. 5, 2013, 12:27 pm), http://www.slate.com/blogs/future_tense/2013/08/05/study_reveals_docto rs_are_spending_even_less_time_with_patients.html, archived at http://perma.cc/yxh4-hges. http://dx.doi.org/10.1016/j.clinthera.2013.03.019 290 indiana health law review vol. 12:1 predominant approach among states is to require patient or physician notification, but a handful require no notification.31 considering the creation of drug formularies, the majority of states have not established them; those that have established formularies did so either by generating a list of drugs that are considered to be interchangeable (positive formulary) or by establishing a list of drugs that are not suitable for substitution (negative formulary).32 additionally, a majority of states employ a cost savings requirement, and only a small minority recognize nti drugs.33 iii. scientific issues with generic substitution though many states favor generics because they cost less than their brand name counterparts and are theoretically equally effective, generic drugs remain controversial due to concerns over the way in which bioequivalence testing is carried out and concerns because generics have differing inactive ingredients from the brand name drug, which can impact drug performance. this section will explore these two drawbacks in detail. a. the limits of pharmacokinetic studies the bioequivalence of generic drugs is typically tested via pharmacokinetic studies in which the test generic and branded reference drugs are compared in terms of how 31 see vivian, supra note 24; avalere health, llc., supra note 30, at 4; u.s. dep’t of health & human serv., supra note 30, at appendix a. as of 2008, four states allowed for mandatory substitution without consent being required: massachusetts, new jersey, rhode island, and washington. seven other states allow for substitution without consent: alabama, arkansas, louisiana, new mexico, north carolina, oregon, and tennessee. vivian, supra note 24. a handful of states approach medicaid patients differently, requiring no patient consent and mandatory substitution: massachusetts, new jersey, new mexico, oregon, rhode island, tennessee, washington, and wyoming. william h. shrank et al., state generic substitution laws can lower drug outlays under medicaid, 29 health affairs 1383, 1386 (2010). 32 vivian, supra note 24. 33 id. 2015 are bioequivalents really equal? 291 quickly the active ingredient in the drugs reaches the absorption site and how much of the active ingredient is absorbed.34 these studies are based on a single-dose administration of the two drugs in a sample of 24 to 36 volunteers.35 however, there are several problems with these pharmacokinetic studies. first, bioequivalence studies typically involve sample groups of healthy adult male volunteers who take no other medications, do not smoke, receive a controlled diet, are of average height and weight, and are between 18 and 55 years old.36 as such, these samples necessarily exclude any investigation of the impact of individual differences in patients that might influence the performance of a medication.37 this is undesirable because it violates a basic premise of statistics: to extrapolate findings to a population, a sample needs to be representative of that population. a sample such as the one described likely is not representative of all the patient populations to which the results of the pharmacokinetic study will be extrapolated, least of all the patient population with the actual illness or disorder that the drug is designed to treat.38 second, the use of a single regulatory acceptance range may be problematic for nti drugs, or “drugs for which a relatively small change in systemic concentration can lead to marked changes in pharmacodynamics response.”39 in fact, a bioavailability difference as small as 3.5% may yield clinical consequences.40 using anticonvulsants as an example, this small difference could result in seizures at the 34 id. 35 id. 36 peter meredith, commentary: bioequivalence and other unresolved issues in generic drug substitution, 25 clinical therapeutics 2875, 2878-79 (2003). 37 id. 38 id. at 2879. 39 id. carbamazepine is an anticonvulsant whose extended-release versions are commonly prescribed to treat bipolar disorders. see carbamazepine, u.s. nat’l inst. of health, http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682237.html, archived at http://perma.cc/mhv4-erzs (last updated mar. 2, 2015). 40 barbara j. zarowitz & todd semla, avoiding potential pitfalls of generic substitution, 30 geriatric nursing 260, 261 (2009). http://dx.doi.org/10.1016/s0149-2918(03)80340-5 http://dx.doi.org/10.1016/j.gerinurse.2009.06.002 292 indiana health law review vol. 12:1 low end or toxicity at the higher end of the bioavailability spectrum.41 third, as bioequivalence is predicated on the assumption that similar bioavailability yields similar treatment results,42 a generic drug does not require a “demonstration of its pharmacokinetics, efficacy, and tolerability in normal and healthy subjects and in the target patient population,” as branded drugs are required to do.43 this undermines the fundamental assumption of bioequivalence, as it is not an established fact that two drugs with similar bioavailability demonstrate equivalent clinical efficacy, only that they demonstrate similar rates and extent of absorption of their active ingredient.44 fourth, bioequivalence studies involve the administration of a single dose of the generic test and branded reference drugs, yet results of these studies are extrapolated to predict the results of use of multiple doses of the drug.45 like the example of the homogenous, nonrepresentative sample described above, this procedure raises generalizability concerns. in actual use, few drugs are administered in single doses; instead, most drugs require maintenance of a steady regimen to achieve the desired therapeutic result.46 the level of drug present in a patient following maintenance of a steady medication regimen is usually substantially higher than the drug levels present with just a single-dose administration, making bioequivalence studies that do not account for this regimen especially problematic.47 also, evidence indicates that the differing inactive ingredients present in generic drugs may influence the metabolism, absorption, and distribution of a drug’s active ingredient when on a steady maintenance regimen in ways that are not observable following a singledose administration.48 lastly, an experiment consisting of a single-dose administration may not properly capture the 41 id. 42 blier & sloan, supra note 25. 43 meredith, supra note 36, at 2878. 44 id. 45 id. at 2879. 46 id. 47 id. 48 id. 2015 are bioequivalents really equal? 293 effects of drugs that have variable pharmacokinetic profiles the way that a multi-dose experiment might.49 b. bioequivalence: do generic drugs really produce the same effects as brand names? although generic drugs are theoretically thought to produce the same results as their brand name counterparts, in reality this may not be true. though generic and brand name drugs share active ingredients, they may differ in terms of their inactive ingredients or the salt form in which the active ingredient is presented.50 these inactive ingredients and differing salt forms can impact the performance of generic drugs in a number of ways. inactive ingredients can influence the effects of a generic drug in two ways. first, and perhaps most obviously, some individuals may be allergic to the inactive ingredients in generic drug formulations, rendering the generic intolerable.51 second, generic and brand name drugs may contain different excipients, or inert substances included in a drug to assist in the process of drug manufacturing, administration, and active ingredient absorption.52 these excipients may trigger, promote, or partake in chemical or physical interactions with a drug’s active ingredient that can jeopardize drug performance and quality.53 chemical interactions between active ingredients and excipients may result in drug intolerability, diminished drug safety, and 49 id. at 2880. 50 meredith, supra note 36, at 2880. a drug’s salt form refers to an “ionisable drug that has been combined with a counter-ion to form a neutral complex.” producing a drug in salt form makes it more chemically stable, allows its pharmacokinetic profile to be manipulated, and allows for easy administration. aateka patel et al., pharmaceutical salts: a formulation trick of a clinical conundrum? 16 brit. j. cardiology 281, 281 (2009). 51 tod cooperman, what you need to know about generic drugs, dr. oz show (apr. 8, 2013), http://www.doctoroz.com/videos/what-youneed-know-about-generic-drugs. 52 patrick krowley & luigi g. martini, drug-excipient interactions, pharmaceutical tech. eur. 26 (mar. 2001) available at http://callumconsultancy.com/articles/drugexcipientinteractions.pdf. 53 id. 294 indiana health law review vol. 12:1 degradation of a drug’s active ingredient.54 physical interactions may impact a drug’s dissolution, its dosage uniformity, or its ease of administration.55 turning next to differing salt forms, the type of salt used to formulate a drug is important, particularly for psychotropic drugs, in that it can influence a drug’s physicochemical properties, such as stability, fluidity, and ability to absorb moisture, as well as a drug’s kinetics and active ingredient absorption rate.56 as previously mentioned, drugs containing different salts of the same active substance are called pharmaceutical alternatives57 and are popular among generic drug makers because they allow for a route around a patent, facilitating earlier entry into the market.58 however, although pharmaceutical alternatives allow for consumers to gain quicker access to generic drug formulations, there are several potential detriments. first, the salt form of a drug’s active ingredient impacts its aqueous solubility, which can lead to disparate in vivo dissolution characteristics between generics and brand names.59 this is important because the dissolution characteristics of a drug determine its active ingredient’s extent and rate of absorption.60 second, differential salt forms of an active ingredient can generate toxicity concerns due to the different conjugate anions or cations used to form the salt compound as well as chemical impurities that may arise during salt formulation.61 third, an active ingredient’s salt form may influence its tolerability, causing undesirable side effects such as stomach irritation or 54 id. 55 id. 56 pawel lewek & przemyslaw kardas, generic drugs: the benefits and risks of making the switch, 59 j. fam. prac. 634, 638 (2010). 57 vivian, supra note 24. 58 r. k. verbeeck et al., generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy, 28 eur. j. of pharmaceutical sci. 1, 1 (2006). 59 id. at 3. 60 id. 61 id. at 3-4. http://dx.doi.org/10.1016/j.ejps.2005.12.001 2015 are bioequivalents really equal? 295 stomach ulcers.62 fourth, salt forms impact polymorphism, or “the ability of a drug substance to exist as two or more crystalline phases that have different arrangements and/or conformations of the molecules in the crystal lattice.”63 polymorphism is important because it impacts equilibrium solubility, a factor in determining the dissolution rate of an active ingredient that can influence bioavailability after oral administration of a medication.64 last, the salt form of an active ingredient can influence its physiochemical properties, which affect a drug’s formulation as well as its large-scale manufacturing by potentially negatively impacting the uniformity, disintegration, and dissolution rate of solid medications.65 two other concerns with generic drug formulations are a drug’s water solubility for nti drugs and the pharmacokinetic profile of modified-release formulations.66 regarding the former, water solubility in nti drugs could lead to concentration differences that can diminish a drug’s effectiveness or render it toxic.67 concerning the latter, active ingredient concentration profiles in modified-release formulations may differ between generics and brand names during the absorption period of an active ingredient, which might impact a drug’s effectiveness despite the fact that the generic drug may technically meet bioequivalence standards.68 iv. generic substitution and mental illness psychotropic medications are drugs targeted at treating and managing the symptoms of mental health disorders.69 they work by adjusting chemical levels in the brain that 62 id. at 4. 63 id. 64 id. 65 id. 66 lewek & kardas, supra note 56, at 638. 67 id. 68 id. 69 nat’l inst. of mental health, mental health medications 1 (2012). 296 indiana health law review vol. 12:1 influence behavior and mood.70 psychotropic medications are used to treat a variety of mental health disorders such as bipolar disorders, anxiety disorders, depressive disorders, and psychotic disorders.71 unfortunately, psychotropic medications are not a cure for mental illness; however, they can be effective in allowing individuals to better function in everyday life.72 this section will provide background on the four major classes of mental health disorders that psychotropic drugs treat, examine the effectiveness of generic psychotropics in treating these disorders, discuss the potential benefits and detriments that consumers may experience if they use generic psychotropics, and outline reasons why we should care about the potential differential effectiveness of these drugs. a. how effective are generics at treating mental illness? 1. bipolar disorders bipolar disorders are mood disorders characterized by the tendency of an individual to vacillate between moods, with the most notable moods being manic (or hypomanic) episodes and major depressive episodes.73 manic episodes are characterized by an extended period of excessive elation or euphoria, often in combination with hyperactivity, decreased need for sleep, and grandiosity; major depressive episodes are characterized by an extended period of severe depression in conjunction with sleep disturbances, decreased interest in and experience of pleasure of 70 enjoli francis, psychotropic drugs: what are they?, abc news health blog (dec. 2, 2011, 5:04 pm), http://abcnews.go.com/blogs/health/2011/12/02/what-you-need-to-knowabout-psychotropic-drugs/, archived at http://perma.cc/4hdb-lza6. 71 nat’l inst. of mental health, supra note 69, at 1. 72 id. 73 am. psychiatric ass’n, diagnostic and statistical manual of mental disorders: dsm-5 123 (5th ed. 2013). bipolar disorder presents in two forms: 1) bipolar i, characterized by the experience of at least one manic episode, and 2) bipolar ii, characterized by at least one major depressive episode and one hypomanic episode. id. at 123-27, 13235. hypomanic episodes are periods of elevated mood that fall between normal mood and manic episodes. id. at 124. 2015 are bioequivalents really equal? 297 previously interesting or pleasurable activities, and feelings of worthlessness.74 bipolar disorders are chronic, often manifesting themselves in adolescence or early adulthood and lasting throughout an individual’s lifetime.75 prevalence rates for bipolar disorders are low, with about .6% of the united states population experiencing bipolar i annually and .8% experiencing bipolar ii annually.76 like some other mood disorders, bipolar is strongly associated with suicide, with some estimates showing that about onethird of individuals with bipolar i or ii attempt suicide at some point during their lifetime.77 this places bipolar individuals at a suicide risk that is at least fifteen times as great as that of individuals without bipolar; further, bipolar individuals may account for up to 25% of suicides.78 most clinicians regard medication to be a necessary component in treating bipolar disorder.79 historically, the most common medications for bipolar disorders were moodstabilizing drugs containing lithium carbonate.80 research has long shown lithium to be a successful treatment for mania,81 being effective in about 50% of patients and providing approximately a 50% reduction in manic symptoms.82 however, despite initial treatment success, 74 id. at 123. 75 id. 76 id. at 130, 136. 77 id. at 138. 78 id. at 131. 79 nat’l alliance on mental illness, bipolar disorder 7 (2011). 80 michael e. thase & timothey denko, pharmacotherapy of mood disorders, 64 ann. rev. clinical psychol. 53, 72 (2008). mood stabilizing drugs are drugs that are generally considered to produce antimanic effects while either not worsening or alleviating depressive symptoms; however, some have proposed a more tailored definition, suggesting that mood stabilizers are those drugs that both alleviate acute manic and depressive symptoms as well as prevent manic and depressive symptoms. see mark s. bauer & landis mitchner, what is a “mood stabilizer”? an evidence-based response, 161 am. j. psychiatry 3, 3 (2004). 81 frederick k. goodman & s. nassir ghaemi, understanding manic-depressive illness, 55 archives gen. psychol. 23, 24 (1998). 82 paul e. keck, jr. & husseini k. manji, current and emerging treatments for acute mania and long-term prophylaxis for bipolar http://dx.doi.org/10.1146/annurev.clinpsy.2.022305.095301 http://dx.doi.org/10.1176/appi.ajp.161.1.3 http://dx.doi.org/10.1001/archpsyc.55.1.23 298 indiana health law review vol. 12:1 relapse rates for individuals on lithium are high, with upwards of 70% of individuals experiencing a relapse within two to five years of commencing the medication.83 further, lithium has serious side effects, as improper dosages can result in poisoning, impaired functioning of the thyroid, significant weight gain, and the development of diabetes insipidus.84 less serious side effects of lithium include sedation, nausea, appetite loss, diarrhea, dizziness, hand tremors, increased thirst, and increased urination.85 these side effects, coupled with the nature of bipolar in general (some individuals enjoy the upswing in mood that occurs during hypomanic episodes or the euphoria associated with mania), often encourage poor medication compliance, significantly increasing individuals’ chances for relapse.86 for those individuals who do not respond to lithium, anticonvulsant drugs, such as those used to treat epilepsy, may help to address manic symptoms; in fact, anticonvulsants—specifically, valproate—have recently overtaken lithium-based medications as the most commonly prescribed medications to treat bipolar disorders.87 anticonvulsants have evidenced similar effectiveness as compared to lithium in managing the symptoms of bipolar; however, while similarly effective at managing bipolar symptoms, anticonvulsants are substantially less effective than lithium at preventing suicide.88 in fact, the rate of disorder, in neuropsychopharmacology: the fifth generation of progress 1109, 1109 (kenneth l. davis et al. eds., 2002). 83 martha sajatovic, bipolar disorder: disease burden, 11 am. j. managed care s80-4 3 supp. (2005), available at http://www.ajmc.com /publications/supplement/2005/2005-06-vol11-n3suppl/jun05-2075ps80 s84/. 84 medications, nat’l alliance on mental illness, http://www.nami.org/template.cfm?section=about_medications&templ ate=/taggedpage/taggedpagedisplay.cfm&tplid=51&contentid=208 20, archived at http://perma.cc/enc4-emep (last visited mar. 18, 2015). 85 id. 86 key points about treatments for bipolar disorder, black dog inst., http://www.blackdoginstitute.org.au/public/bipolardisorder/treatments/bipo lardisorder.cfm, archived at http://perma.cc/v49c-vngq (last visited mar. 18, 2015). 87 thase & denko, supra note 80, at 72. 88 id. 2015 are bioequivalents really equal? 299 completed suicides while taking anticonvulsants is nearly three times as great as the rate for individuals taking lithium.89 though studies examining the effectiveness of generic lithium to branded drugs are extremely scarce, a handful of studies examining the effectiveness of generic versus branded anticonvulsants in the treatment of bipolar disorders exists due to the significant amount of literature on generic versus branded drugs in the treatment of epilepsy that includes bipolar outcomes; a handful of studies have also examined the comparative effectiveness of other antidepressants and mood stabilizers. results from a 1979 study found sub-therapeutic levels of lithium in the blood for generic as opposed to branded lithium-based mood stabilizers.90 regarding anticonvulsants, one study indicates that depressive symptoms and suicidal thoughts worsened upon switching from branded divalproex to generic valproic acid (though this occurred in a patient with schizophrenia), and several studies suggest an increase in gastrointestinal side effects when taking generic versus branded valproic acid.91 several studies have indicated potential deleterious side effects for generic as opposed to branded lamotrigine, with one study observing increases in anxiety, mood swings, dizziness, agitation, headaches, insomnia, and bad taste in the mouth, and another study observing side effects of ataxia, falls, and vertigo.92 2. anxiety disorders anxiety disorders are characterized by persistent feelings of anxiety, apprehension, and tension, usually centered around perceived future misfortune or danger.93 these feelings may manifest themselves emotionally 89 id. 90 julie e. desmarais et al., switching from brand-name to generic psychotropic medications: a literature review, 17 cns neuroscience & therapeutics 750, 751 (2011). 91 id. at 751-53. 92 id. at 753-54. antidepressants and other mood stabilizers are discussed infra section iii(a)(3). 93 am. psychiatric ass’n, supra note 73, at 189. http://dx.doi.org/10.1111/j.1755-5949.2010.00210.x 300 indiana health law review vol. 12:1 (fear/phobias, reliving trauma), physiologically (fight-orflight arousal, muscle tension and panic attacks), behaviorally (facial expressions, fidgeting, avoiding stimuli associated with trauma, repetitive or impulsive behaviors), and cognitively (obsessions/compulsions).94 anxiety disorders are common, with generalized anxiety disorder (gad) estimated to impact .9% of american children, 2.9% of adults annually, and 9% of people within their lifetime;95 panic disorder (pd) affecting 3% of the population annually;96 and posttraumatic stress disorder (ptsd) affecting 8.7% of the population by age 75 and 3.5% annually.97 however, social phobia and specific phobias are more prevalent, affecting an estimated 7-9% of the population every year, though the annual rate of specific phobias is roughly doubled in adolescents.98 obsessivecompulsive disorder (ocd) is more rare by comparison, with prevalence rates of 1.2% annually.99 medication is commonly used to treat anxiety disorders, with several classes of medications demonstrating efficacy. benzodiazepines may be used to treat gad and pd;100 however, benzodiazepines are not recommended for longterm use given that they do not alleviate symptoms for onethird of people, may impair cognition, exhibit potential for abuse and withdrawal, and, in some studies, show no therapeutic benefit past four to six weeks.101 regarding pd, 94 id. at 235. 95 id. at 223. 96 id. at 210. 97 id. at 276. in the dsm-5, ptsd is no longer categorized with the anxiety disorders as in the dsm-iv-tr, but rather with traumaand stressor-related disorders. am. psychiatric ass’n , highlights of changes from dsm-iv-tr to dsm-5 5 (2013), available at http://www.dsm5.org/documents/changes%20from%20dsm-ivtr%20to%20dsm-5.pdf. 98 am. psychiatric ass’n., supra note 73, at 204. 99 id. at 239. in the dsm-5, ocd is no longer categorized with the anxiety disorders as in the dsm-iv-tr, but rather is given its own classification. am. psychiatric ass’n., supra note 97, at 5. 100 joseph rabatin & lynn buckvar keltz, generalized anxiety and panic disorder, 176 w. j. med. 164, 165-67 (2002). 101 jack m. gorman, treating generalized anxiety disorder, 64 j. clinical psychiatry 24, 25 (2 supp. 2003); but see generally vladan http://dx.doi.org/10.1136/ewjm.176.3.164 2015 are bioequivalents really equal? 301 though benzodiazepines have shown therapeutic success, the relapse rate when they are discontinued is quite high, hovering close to 90%.102 two types of antidepressants, selective serotonin reuptake inhibitors (ssris) and serotonin norepinephrine reuptake inhibitors (snris), have shown efficacy for pd;103 however, ssris may cause sexual dysfunction, a side effect that can discourage treatment compliance.104 this is a concern, especially given that the general medication compliance rate is only about 20% across medications.105 concerning ocd, ssris benefit approximately 60% of patients, though relapse is common if use of the medication is discontinued.106 additionally, multiple classes of antidepressants may help to relieve symptoms of social anxiety,107 and ssris may help to relieve symptoms of ptsd.108 although not as extensive as the literature comparing generics and branded drugs for other mental health disorders (though, realistically the literature is thin for all starcevic, the reappraisal of benzodiazepines in the treatment of anxiety and related disorders, 14 expert rev. neurotherapeutics 1275 (2014) (arguing that recent research suggests that benzodiazepines are safe for long-term use and should be considered a first-line, long-term treatment for gad and pd). 102 abby j. fyer et al., discontinuation of alprazolam treatment in panic patients, 144 am. j. psychiatry 303 (1987), available at http://www.benzo.org.uk/alprazolam.htm, archived at http://perma.cc/snl7-7d3a. 103 charles b. pull & cristian damsa, pharmacotherapy of panic disorder, 4 neuropyschiatric disease & treatment 779, 781-785 (2008). 104 deepak prabhakar & richard balon, how do ssris cause sexual dysfunction?: understanding key mechanisms can help improve patient prognosis, adherence, 9 current psychiatry 30, 30 (2010). 105 v. mark durand & david h. barlow, essentials of abnormal psychology: instructor’s edition 132-33 (6th ed. 2013). 106 id. at 155. 107 michael van ameringen et al., pharmacotherapy for social anxiety disorder: an update, 46 israeli j. psychiatry & related sci. 53, 53 (2009). 108 gregory m. asnis et al., ssris versus non-ssris in posttraumatic stress disorder: an update with recommendations, 64 drugs 383, 383-91 (2004). http://dx.doi.org/10.1586/14737175.2014.963057 http://dx.doi.org/10.1176/ajp.144.3.303 http://dx.doi.org/10.2147/ndt.s1224 http://dx.doi.org/10.2165/00003495-200464040-00004 302 indiana health law review vol. 12:1 mental illnesses), a couple case studies exist comparing generic anti-anxiety medications to their brand name counterparts. a 1997 study suggested that generic clonazepam may cause greater levels of sedation and decreased management of anxiety compared to the branded version; additionally, generic clonazepam was associated with side effects of fatigue and dizziness.109 a 1991 case study indicated that a middle-aged woman with severe pd experienced panic attacks when switched from her original generic to generic alprazolam; these attacks were not present with the original generic and disappeared when the original generic was reinstituted.110 3. major depressive disorder major depressive disorder (“mdd”) is characterized by recurrent depressed mood (including the presence of a major depressive episode), cognitive distortions, and impaired physical functioning to the point where it causes significant distress and impairment and interferes with daily functioning.111 common symptoms include feelings of worthlessness, guilt, or indecisiveness; loss of energy; fatigue; diminished interest in once enjoyable activities; psychomotor disturbances; difficulties in thinking and concentrating; significant weight fluctuations; sleep disturbances; and suicidal ideation.112 mdd is quite prevalent, with 16.2% of individuals estimated to experience the disorder at some point in their lifetime and 6.6% experiencing the disorder within any given year; these percentages may be significantly higher in elderly individuals and in women.113 disconcertingly, mdd is associated with a high risk of suicide, with untreated individuals having a lifetime risk of about 20%, and the rate 109 desmarais et al., supra note 90, at 756. 110 id. at 757. 111 am. psychiatric ass’n, supra note 73, at 160. 112 id. at 160-63. 113 derek richards, prevalence and clinical course of depression: a review, 31 clinical psychol. rev. 1117, 1118 (2011). http://dx.doi.org/10.1016/j.cpr.2011.07.004 2015 are bioequivalents really equal? 303 of completed suicides being twenty times higher than that of the general population.114 mdd is often treated with antidepressant medications, which fall into one of four categories: ssris, monoamine oxidase inhibitors (“maoi”), mixed reuptake inhibitors, and tricyclic antidepressants.115 research indicates that all four types of antidepressants, at least initially, are equally efficacious, reducing depressive symptoms in about 50% of patients and achieving remission of depressive symptoms in about 25% of patients.116 however, the drugs differ in terms of their side effects: ssris may produce physical agitation, sexual dysfunction, decreased sex drive, insomnia, and upset stomach; maois, in combination with the consumption of foods and drinks containing tyramine, may cause hypertension or even death; and tricyclic antidepressants may produce vision difficulties, difficulties in waste elimination, dry mouth, drowsiness, sexual dysfunction, and weight gain; all of these side effects may lead to reduced levels of medication adherence.117 further, despite medication use, relapse rates for depression are high, with 50% of patients relapsing if medication use is discontinued too soon after a major depressive episode.118 though branded antidepressants appear to be effective in the treatment of some depressive disorders, generic versions may not perform as well by comparison, as indicated by a handful of studies.119 generic amitriptyline 114 am. ass’n of suicidology, some facts about suicide and depression, am. ass’n. of suicidology, 1, 2 (2010), http://211bigbend.net/pdfs/factsaboutsuicideanddepression.pdf. 115 mayo clinic staff, antidepressants: selecting the one that’s right for you, mayo clinic, (nov. 18, 2014), http://www.mayoclinic.org/diseases-conditions/depression/indepth/antidepressants/art-20046273, archived at http://perma.cc/684a2bhw (also noting that another type of antidepressant, the “atypical” antidepressant, is grouped in a catch-all category because it does not fall neatly into any particular category of antidepressants). 116 durand & barlow, supra note 105, at 227. 117 id. at 227-28. 118 id. at 233. 119 christoph u. correll & maren carbon, branded vs. generic psychotropic medication: is one better than the other?, nwpmd 1 (2012), 304 indiana health law review vol. 12:1 produced worsened depression symptoms, decreased blood levels, and increased agitation compared to the branded version; generic mirtazapine (avanza), desipramine (norpramin), paroxetine (paxil), citalopram (celexa), and fluoxetine (prozac) are also reported to produce worsened depressive/psychiatric symptoms compared to branded versions.120 generic fluoxetine was reported to produce increased anxiety, allergic reactions, relapse of comorbid obsessive-compulsive disorder, and diarrhea; additionally, generic nortiptyline (aventyl) was reported to produce severe intoxication.121 finally, at least one study of generic venlafaxine (efexor) indicates that its bioavailability does not fall within the acceptable 80% to 125% range of its branded reference drug as required by the fda.122 4. schizophrenia and psychotic disorders schizophrenia is a psychotic disorder characterized by a mixture of cognitive, emotional, perceptual, speech, and behavioral disturbances. common symptoms include disorganized speech, displaying inappropriate emotions or flat affect, experiencing hallucinations and/or delusions, paranoia, and catatonic movement.123 schizophrenia affects about .7% of people at some point in their lives, and the disorder can produce numerous deleterious effects for the individuals who suffer from it, as well as cast a significant financial burden on society; it is estimated that the cost of treating schizophrenics may exceed $60 billion annually.124 schizophrenia is a chronic disorder. even with treatment, full and complete recovery is rare; however, psychotic symptoms tend to subside over time.125 as such, the treatment focus for those with schizophrenia is often not on curing the disorder but on managing its symptoms. this is https://www.nwpmd.com/portals/0/gallery/articles/branded%20vs%20g eneric%20psychotropic%20medications%20(printer-friendly).pdf. 120 id. 121 id. 122 id. 123 am. psychiatric ass’n, supra note 73, at 100-01. 124 id. at 102. 125 id. at 102-03. 2015 are bioequivalents really equal? 305 commonly carried out through the administration of antipsychotic medications.126 research regarding medications for schizophrenia reveals some troubling findings. first, although antipsychotics can help to alleviate symptoms of schizophrenia, they only do so in about 60% of individuals.127 second, medication adherence rates for those with schizophrenia are low, with some studies finding that nearly three-quarters of those with schizophrenia stop taking their medications within eighteen months.128 third, antipsychotics can produce a host of uncomfortable side effects, such as grogginess, blurred vision, dry mouth, akinesia, and motor abnormalities, which contribute to the aforementioned low medication adherence rate.129 though the treatment of schizophrenic individuals with branded medications already presents some difficulties, these difficulties can be compounded when generic medications are utilized. although some studies suggest generic and branded first-generation antipsychotics perform equivalently, other studies suggest that patients on generic versions may require increased dosage adjustments and may experience exacerbated side effects, such as unprovoked outbursts and drowsiness.130 similarly, although a handful of studies have demonstrated the efficacy of generic clozapine in treating schizophrenia, another handful have suggested that individuals receiving generic clozapine experience either worsened symptoms or relapse at greater rates than do individuals on branded versions.131 regarding another antipsychotic, risperidone, 126 kiran panesar, schizophrenia: managing symptoms with antipsychotics, 37 u.s. pharmacist (epub.) (nov. 20, 2012), http://www.uspharmacist.com/content/d/web_exclusive/c/37743/. 127 durand & barlow, supra note 105, at 472-73. 128 id. 129 consumer reports best buy drugs, evaluating prescription drugs used to treat schizophrenia and bipolar disorder: comparing effectiveness, safety, and price 8 (2009), available at http://www.consumerreports.org/health/resources/pdf/bestbuy-drugs/antipsychoticsfinal.pdf. 130 desmarais et al., supra note 90, at 755. 131 id. 306 indiana health law review vol. 12:1 at least one study challenged the bioequivalence of generic versions of the drug to the branded risperdal®,132 indicating that the generic’s bioavailability did not fall within the fda’s required 80% to 125% range.133 b. benefits and detriments of generic substitution of medications for consumers the substitution of generic versions of psychotropic medications provides at least one potential benefit to consumers. although inactive ingredients in generic medications may influence the way that drugs are absorbed into the body, this risk is more severe for drugs with narrow therapeutic indexes; the risks of differential effectiveness of generic in comparison to branded drugs is less pronounced for psychotropic drugs with high therapeutic indexes.134 to this end, the cost savings provided by using generic psychotropics may be well worth the small risk of differential effectiveness between generics and brand names for drugs with high therapeutic indexes. for some drugs, the costs savings can be substantial; for example, the branded amphetamine adderall®135 costs approximately $84 for a 30-day supply, whereas generics dexedrine® and dexamphetamine cost over $50 less for the same thirty-day supply.136 similarly, a 60% increase in the dispensing of generic antidepressants decreased medication costs by 9%.137 additionally, this reduction in price may also indirectly impact treatment compliance; lower copays may increase the likelihood that consumers are willing to persist in therapy.138 132 risperdal, registration no. 1830761. 133 desmarais et al., supra note 90, at 755. 134 laura ladue, generic psychotropic medications: issues of costeffectiveness and patient benefit, 104 s. med. j. 711, 712 (2011). see also liang et al., supra note 28, for a refresher regarding the dangers of nti drugs. 135 adderall, registration no. 1908092. 136 ladue, supra note 134, at 712. 137 id. 138 lewek & kardas, supra note 56, at 638. 2015 are bioequivalents really equal? 307 despite the economic benefit for consumers stemming from the substitution of generic drugs for branded versions, consumers may also experience myriad detriments. first, as discussed above, generic psychotropics, at least for some individuals, may not be as effective at treating their mental illness as brand name psychotropics.139 second, the substitution of generic psychotropics, at least under schemes without the requirement of notification or consent of the consumer or doctor, may infringe on individuals’ autonomy in making their own medical decisions.140 third, generic substitution tends not to reflect consumer preferences. in a 2009 survey of 1047 people, researchers found that while a majority of americans support the idea of generic substitution, 10% thought that generics caused a greater number of side effects compared to branded drugs, one-third of individuals expressed some degree of discomfort with generic substitution, and only 38% expressed a personal preference for generics, a result that is contradictory given that a majority reported favoring the idea.141 this suggests that americans may believe that generic drugs are right for others, but not for themselves. this effect is less pronounced in younger, more educated consumers, but is also strongly influenced by the seriousness of the illness being considered, with individuals expressing a greater preference for brand-name drugs for more serious illnesses.142 c. why should we care? though there may be both benefits and detriments to the substitution of generic psychotropics, the detriments outweigh the potential benefits for three reasons. first, some mental illnesses are chronic diseases, meaning that individuals with those disorders who are treated with 139 see supra part iii(a). 140 see infra part iii(c)(3). 141halle håkonsen & else-lydia toverud, a review of patient perspectives on generics substitution: what are the challenges for optimal drug use, 1 generics & biosimilars initiative j. 28, 30 (2012). 142 ladue, supra note 134, at 713. http://dx.doi.org/10.5639/gabij.2012.0101.008 308 indiana health law review vol. 12:1 medications will likely face numerous medication decisions in their lifetime. second, given that medication is a favored treatment for some mental health disorders, medication adherence is a concern and may be negatively impacted by the substitution of generic psychotropics. third, generic substitution of psychotropic medications may lead to several unanticipated problems, such as difficulty in determining criminal liability under both utilitarian and retributivist theories as well as exposing pharmacists to liability for the potential differential impacts that can arise from generic substitution. fourth, the recent united states supreme court ruling in mutual pharmaceutical co., inc. v. bartlett and the court’s holding in pliva, inc. v. mensing limits the ability of individuals injured by a generic drug to seek remedy.143 1. mental health disorders as chronic disorders of the four aforementioned mental disorders, schizophrenia, mdd, and bipolar are viewed as chronic conditions. roughly 75% of individuals afflicted with schizophrenia will experience alternating periods of relapse and remission during the course of their lifetime, with full recovery constrained to under one-fifth of cases.144 regarding bipolar disorders, recent research suggests that bipolar manifests itself in a chronic course “characterized by periods of residual symptoms, emotional dysregulation, sleep and circadian rhythm disturbances, cognitive impairment, and increased risk for psychiatric and medical comorbidity between mood episodes.”145 considering major depressive disorder, research suggests that it is an episodic yet persistent condition, with about three-quarters of individuals who reached clinical levels of depression 143 mut. pharm. co., inc. v. bartlett, 133 s. ct. 2466 (2013); pliva, inc. v. mensing, 131 s. ct. 2567 (2011). see infra part iii(c)(5). 144 alfredo carlo altamura et al., rethinking the role of longacting atypical antipsychotics in the community setting, 27 int’l clinical psychopharmacology 336, 337 (2012). 145 marion leboyer & david j. kupfer, bipolar disorder: new perspectives in health care and prevention, 71 j. clinical psychology 1689, 1689 (2010). http://dx.doi.org/10.1097/yic.0b013e328357727a 2015 are bioequivalents really equal? 309 reporting that they had experienced multiple depressive episodes.146 given that major depressive disorder, bipolar, and schizophrenia are viewed as chronic disorders and that medication plays a key role in the treatment of all three, care should be taken to provide individuals with these disorders the best and most effective medication.147 as indicated previously, for some individuals, generic psychotropic drugs will not fit this bill.148 2. medication adherence given that medication is a key part of treatment for schizophrenia, major depressive disorder, and bipolar, medication adherence is essential. despite its importance, many individuals with mental illness do not comply with their medication regimens; some estimates indicate that as many as half of individuals on medication for psychiatric illness are not fully adherent.149 this is problematic, as non-adherence may lead to poor treatment outcomes such as relapse, weakened treatment benefits, and hospitalization.150 a number of factors may influence non-adherence. some non-adherence is related to characteristics of individuals, such as a lack of insight into their disease, forgetfulness, the severity of the illness, experiencing depressive and psychotic symptoms, low cognitive ability, and substance 146 gavin andrews, education and debate: should depression be managed as a chronic disease?, 322 bmj 419, 419-20 (2001). 147 nat’l alliance on mental illness, major depression fact sheet, nami 1 (2013), http://www.nami.org/factsheets/depression_factsheet.pdf; nat’l alliance on mental illness, bipolar disorder fact sheet, nami 1 (2013), http://www.nami.org/factsheets/bipolardisorder_factsheet.pdf; nat’l alliance on mental illness, schizophrenia fact sheet, nami 1 (2013), http://www.nami.org/factsheets/schizophrenia_factsheet.pdf. 148 see supra part ii(a)-(d). 149 boosting medication adherence to psychotropic drugs, mpr (sep. 5, 2013), http://www.empr.com/boosting-medication-adherence-topsychotropic-drugs/article/310444/. 150 alex j. mitchell & thomas selmes, why don’t patients take their medicine? reasons and solutions in psychiatry, 13 advances in psychiatric treatment 336, 338 (2007). http://dx.doi.org/10.1136/bmj.322.7283.419 http://dx.doi.org/10.1192/apt.bp.106.003194 310 indiana health law review vol. 12:1 dependency.151 some non-adherence stems from the therapeutic alliance, with individuals who perceive their doctor as helpful, trustworthy, and collaborative more likely to be adherent than those who do not perceive their doctor in those ways.152 still other non-adherence may be influenced by external factors, such as stigma, cost, and availability.153 however, most important to this article is that some non-adherence stems from factors having to do with the medications themselves. research indicates that individuals are less likely to be adherent when they experience adverse side effects from a medication, such as weight gain or sexual dysfunction.154 research also indicates that individuals are more likely to be adherent to a brand name as opposed to a generic medication.155 additionally, medication switching influences adherence— individuals who notice repeated changes to the shape, color, or packaging of their medications are less likely to be adherent to a medication regimen than those who do not experience such changes.156 this influence may be magnified for individuals with psychotic symptoms, who may perceive such changes to be indicative of maltreatment.157 given the many reasons individuals may not be adherent to their medication, including brand name medications, it seems foolhardy to compound these reasons by introducing the possible detrimental effects of switching individuals from a brand name to a generic without their consent. 3. patient autonomy: the right to medical decision making in addition to presenting scientific and treatment concerns, generic substitution may present a legal concern 151 id. 152 id. at 339. 153 id. at 338. 154 id. 155 id. 156 correll & carbon, supra note 119. 157 id. 2015 are bioequivalents really equal? 311 by detrimentally impacting patient autonomy. the right to medical decision making has long been considered a fundamental right, as evidenced in the united states supreme court cases of griswold v. connecticut,158 roe v. wade,159 and cruzan v. director, missouri department of health.160 in griswold, the court established a penumbral right to privacy that included an inability of the government to restrict a couple’s access to contraceptives.161 in roe, a case in which a woman’s right to an abortion was disputed, the court held that abortion was a private medical decision and a fundamental right under the due process clause.162 158 381 u.s. 479 (1965). 159 410 u.s. 113 (1973). 160 497 u.s. 261 (1990). a fundamental right is one which is “deeply rooted in [the] nation’s history and tradition” such that it is “implicit in the concept of ordered liberty” and that “neither liberty nor justice would exist if they were sacrificed.” washington v. glucksburg, 521 u.s. 702, 721 (1997) (quoting respectively moore v. east cleveland, 431 u.s. 494, 503 (1977) (plurality opinion); palko v. connecticut, 302 u.s. 319, 325-26 (1937)). fundamental rights can only be restricted when a jurisdiction has a compelling purpose to do so and its scheme is narrowly tailored to the purpose. reno v. flores, 507 u.s. 292, 302 (1993). 161 griswold, 381 u.s. at 484-86. in griswold, plaintiffs griswold (executive director of planned parenthood league of connecticut) and buxton (medical director of the planned parenthood league of connecticut) were arrested for providing contraceptive counseling to married couples in violation of a connecticut statute preventing contraception by medical means. id. at 480. the court held the law to be unconstitutional, reasoning that it “operate[d] directly on an intimate relation of husband and wife and their physician’s role in one aspect of that relation,” that such a relationship fell within the penumbral right to privacy emanating from the first, third, fourth, fifth, and ninth amendments, and that the law, in prohibiting the use of contraceptives, swept too broadly and exacted “the maximum destructive impact upon that relationship.” id. at 481-87. 162 roe, 410 u.s. at 162-67. roe involved plaintiff jane roe (pseudonym), a pregnant woman who desired a legal abortion to terminate her pregnancy. id. at 120. at the time, abortion was illegal in her home state of texas unless it was necessary to protect the life of the mother. id. at 119. roe argued that texas’s blanket prohibition of abortion in all other instances amounted to an invasion of her penumbral privacy rights stemming from the first, third, fourth, fifth, ninth, and fourteenth amendments, and as such was unconstitutional. id. at 120. the court agreed, holding the right to an abortion to be a 312 indiana health law review vol. 12:1 in cruzan, a case in which a vegetative woman’s right to refuse life support was at issue, the court held that competent individuals have a right to refuse medical treatment if they so choose.163 extending these holdings to generic substitution, taking prescription medication is a private medical decision, much like abortion or contraception. additionally, much like cruzan, competent individuals should have the ability to refuse medical treatment, meaning that individuals should have an opportunity to dissent to the substitution of a generic in place of a brand name medication—this is not possible under generic substitution schemes that require no notification or consent. as such, the right of individuals to confer with their doctor and choose which medications they would like to be prescribed should be a fundamental right fundamental right and that while texas had some compelling reasons for restricting abortions, such as protecting health and potential life, a blanket prohibition was broad enough that it exceeded the bounds of those compelling interests. id. at 162-67. the court held similarly in a lesser-recognized companion case to roe, doe v. bolton. doe v. bolton, 410 u.s. 179 (1973). doe involved plaintiff mary doe (pseudonym), a married woman who desired the ability to obtain a legal abortion in her home state of georgia. id. at 185. at the time, georgia law prohibited abortion except in cases where it was necessary to save the life of the mother, where the pregnancy was the result of rape, or where the child was at risk of being born with a serious defect or disability; additionally, the statute contained a host of procedural restrictions. id. at 182-84. doe alleged that georgia’s prohibition of abortion in all cases not involving these exceptions violated her penumbral privacy rights emanating from the first, third, fourth, fifth, ninth, and fourteenth amendments. id. at 184-86. utilizing similar reasoning to roe, the court reaffirmed its roe holding that abortion for women was a fundamental but not absolute right and that numerous of the procedural restrictions on abortion were invalid as being overly broad. id. at 189-202. 163 cruzan, 497 u.s. at 278. cruzan involved the case of nancy cruzan, a woman who had fallen into a vegetative state as a result of injuries sustained in a car accident. id. at 265-66. cruzan’s parents wanted her removed from life support, but hospital staff refused to do so absent a court order. id. at 267-68. although the court held that individuals did have a fundamental right to refuse life-saving medical treatment, it also upheld a missouri standard requiring clear and convincing evidence of an incompetent individual’s desire to refuse this treatment. id. at 277-86. 2015 are bioequivalents really equal? 313 with which the government, by way of using a pharmacist as a proxy, should not be able to interfere. in addition to considering the right to medical decision making to be a fundamental right, the court has held that persons with mental illness have a right not to be coerced into treatment or into taking a medication, as illustrated in the landmark cases of o’connor v. donaldson164 and washington v. harper,165 as well as subsequent decisions such as perry v. louisiana,166 riggins v. nevada,167 and sell v. united states.168 in o’connor v. donaldson, the court held that it was unconstitutional to forcibly confine a nondangerous individual with mental illness for the purposes of treatment when he was capable of living in the community either on his own or with assistance.169 in washington v. harper, the court ruled that the state could forcibly medicate an inmate with antipsychotics, but restricted such forcible medication to situations in which the state had sufficiently shown that the inmate constituted a danger to himself or others and that the medication prescribed was in his best medical interest, indicating a right of nondangerous individuals not to be medicated against their will.170 164 422 u.s. 563 (1975). 165 494 u.s. 210 (1990). 166 498 u.s. 38 (1990). 167 504 u.s. 127 (1992). 168 539 u.s. 166 (2003). 169 donaldson, 422 u.s. at 576. o’connor v. donaldson involved the case of kenneth donaldson, a florida man who had been civilly committed to a mental hospital due to paranoid schizophrenia. id. at 564-66. though he posed no danger to himself or to others, j.b. connor, the hospital superintendent, refused to release donaldson, deeming that he would be unable to adjust to deinstitutionalized life. id. at 566-67. however, trial testimony indicated that donaldson was capable of securing employment outside the hospital setting, and that he had the support of numerous individuals willing to assist him upon his release. id. at 568. 170 harper, 494 u.s. at 233-36. harper involved the case of walter harper, a washington man convicted of robbery. id. at 213. while imprisoned, he initially consented to be treated with antipsychotic drugs to treat symptoms of schizophrenia; however, he later withdrew that consent and was medicated against his will. id. at 214-15. in an earlier case, vitek v. jones, the court held that the involuntary transfer of an 314 indiana health law review vol. 12:1 in perry v. louisiana, the court per curiam vacated a ruling of the louisiana supreme court that authorized the forcible medication of an inmate for the purpose of declaring the inmate competent for execution.171 riggins v. nevada concerned the right of an inmate to refuse medication that would render him competent to stand trial; the court held that forcible medication for this purpose was unconstitutional under the due process clause unless the state could show that such forcible medication was medically appropriate and that competence could not be restored through less intrusive means.172 last, following the framework set by riggins, in sell v. united states the supreme court held it to be unconstitutional to forcibly medicate a prisoner for the sake of restoring competence to stand trial unless the medication was in furtherance of an important government interest (to be decided on a case-bycase basis); substantial certainty existed to believe that the medication would render the individual competent without the substantial risk of detrimental side effects; less intrusive alternative measures that could restore competency did not exist; and, that the administration of medication was “medically appropriate.”173 inmate to a state mental hospital for treatment of a mental or disease or defect, absent notice and a hearing, violated a prisoner’s fourteenth amendment right to due process. 445 u.s. 480, 492-93 (1980). 171 perry, 498 u.s. 38 (1995). 172 riggins, 504 u.s. at 133-36. riggins involved the case of david riggins, a nevada man accused of robbery and murder. id. at 129. while awaiting trial, riggins complained that he was having auditory hallucinations and was having trouble sleeping, and was prescribed antipsychotics. id. at 129. riggins moved for a determination of his competence to stand trial and was found competent; upon this finding, riggins argued that he wanted to assert an insanity defense against trial, and it was a violation of his due process rights to medicate him as it (1) would not allow him to show his natural state at trial and (2) the drug’s negative impacts on him would impede his ability to contribute to his defense. id. at 129-30. the prosecution argued that, since taking him off antipsychotics would render riggins incompetent to stand trial and nevada law prohibited the trial of incompetent individuals, riggins could be compelled to take antipsychotics. id. at 130. 173 sell, 539 u.s. at 180-186. “medically appropriate” means that, in light of the individual’s medical condition, the administration of drugs is in his best medical interests. id. at 181. 2015 are bioequivalents really equal? 315 in applying these holdings to the issue of generic substitution, the supreme court has made it clear that, at least regarding prisoners with mental illness, forcible treatment and medication is to be considered a measure of last resort. this is interesting in light of the court’s holding in turner v. safley, which indicated that, given reduced individual liberty and security concerns in prisons, prisons should be given deference in the restriction of prisoners’ rights provided that such restrictions were “reasonably related to legitimate penological interests.”174 if prisoners, whom the court has recognized as being subject to liberty and rights restrictions not imposed upon everyday citizens, are not subject to medication against their will except under a strict set of circumstances, why then would it be fair or constitutional to allow individuals who are mentally ill to have a generic drug substituted for a brand name drug when their will regarding such substitution is not known, as in generic substitution schemes that do not involve a consumer’s or doctor’s notification or consent? third, generic substitution may constitute a battery under tort law. most jurisdictions provide for battery actions for patients who did not consent to a medical treatment.175 a majority of jurisdictions allow for patients to recover when they consent to a medical treatment but the physician deliberately deviates from the patient’s wishes; additionally, some jurisdictions hold that physicians will be held liable if they provide medical treatment to which a patient has not given express or implied consent.176 an argument can be made that this conception of medical battery should apply to generic substitution, at least in the abstract. first, although pharmacists are not physicians, they play a role in the treatment process as the gatekeepers of medications. second, under permissive substitution schemes, pharmacists can exercise their discretion in choosing to fill a patient’s prescriptions with a generic, effectively allowing them to make a treatment 174 482 u.s. 78, 89 (1987). 175 nancy j. moore, intent and consent in the tort of battery: confusion and controversy, 61 am. u. l. rev. 1585, 1646 (2012). 176 id. at 1648. 316 indiana health law review vol. 12:1 decision for a patient. third, under a scheme that is both permissive and does not require patient or doctor notification, a pharmacist might ostensibly make a treatment decision but never need to inform the patient, thus never providing the patient an opportunity to render either express or implied consent to the pharmacist. given the fact that generic substitution may allow for pharmacists to facilitate administration of a treatment without obtaining consent, a pharmacist who decides to substitute a generic drug that has differential effectiveness or detrimental side effects compared to a brand name drug should be liable for battery, at least from a theoretical perspective. all three of the above issues illustrate potential concerns that may arise when considering the impact of generic substitution on patients’ rights to have a voice in their medical treatment. the supreme court has long recognized the privacy of individuals’ medical decisions with their doctors and the right of individuals not to be medicated without their consent. ostensibly, tort law should allow for patient recovery if consumers are provided with medication for which they did not consent. although not all generic substitution schemes are subject to these problems, schemes involving no notification arguably are, and as such should be viewed as a violation of a consumer’s right to autonomy in medical decision making. 4. seemingly overlooked problems: criminal culpability and pharmacist liability another legal reason for concern regarding generic substitution stems from the seemingly overlooked problems of criminal culpability and pharmacist liability. considering criminal culpability, so-called “psychotropic defenses” are gaining popularity, as evidenced in both news reports177 and in the 2013 film side effects.178 the defense 177 dan childs & lauren cox, did the drugs make him do it? the zoloft defense, abc news (june 4, 2009), http://abcnews.go.com/health/sleep/drugs-make-zoloftdefense/story?id=7750816, archived at http://perma.cc/af6t-cp7f; colin poitras, judge accepts prozac defense, the courant, feb. 25, 2015 are bioequivalents really equal? 317 is predicated on controversial research, which indicates that some psychotropic drugs may spur an adverse reaction in the form of violent behavior.179 although controversial, adverse reactions to psychotropic drugs should diminish culpability, at least theoretically. under the american system of justice, punishment is justified under two main theories: utilitarianism and retributivism.180 utilitarianism is predicated on the idea that punishment can function as a social good, helping to protect society and offenders through general and specific deterrence, rehabilitation, and isolation.181 retributivism, on the other hand, has its foundation in morality—for justice to be served, a wrongdoer must be punished for his actions.182 applying the principles of punishment to the psychotropic defenses, at least in the context of substitution that requires no notification, under utilitarian rationales individuals’ behavior cannot be deterred if it is not a function of their personality but rather a byproduct of a reaction to a medication people did not know that they were taking. additionally, punishment of an individual claiming a psychotropic defense would not serve the purposes of rehabilitation and isolation—proper rehabilitation in this instance would not be punishment but rather would be switching the individual back to a medication regimen that was tolerable and did not produce the adverse effects that precipitated a crime, thus rendering no need for isolation. similarly, under a retributivist rationale in which moral wrongdoing is punished, it is hard to see how justice might be served by punishing individuals whose volition may have 2000, http://articles.courant.com/2000-02-25/news/0002250027_1_lymebank-robbery-mental-health, archived at http://perma.cc/am4-mppk. 178 side effects (open road films 2013). for a plot summary of the movie, see side effects, imdb, http://www.imdb.com/title/tt2053463/, archived at http://perma.cc/ec4l-9vhn. 179 michael welner et al., psychotropic medications and crime: the seasoning of the prozac defense, in handbook of drug interactions: a clinical and forensic guide 635-37 (ashraf mozayani & lionel p. raymon eds., 2004). 180 albin eser, the nature and rationale of punishment, 28 cardozo l. rev. 2427, 2427-29 (2007). 181 id. 182 id. 318 indiana health law review vol. 12:1 been impaired by a drug they did not know they were taking, negating any intention to do wrong. another controversial defense that generic substitution may engender is involuntary intoxication. under common law, a defense of involuntary intoxication may arise when a defendant ingests a substance that induces an adverse reaction that triggers criminal activity, and that substance was ingested due to the negligence or malpractice of a physician or the malevolent intentions of another person.183 though an involuntary intoxication defense usually stems from the ingestion of alcohol or an illegal drug, some courts recognize the defense when the criminal action is precipitated by a wrongly administered medication or by a medication administered correctly but that produced an unexpected effect.184 extended to the example of generic substitution, a medication may be interpreted to be wrongly administered when consumers thought they were taking a brand name medication but in reality were taking a generic. this can also happen when consumers experience adverse reactions to a medication that they did not expect based on their understanding of the brand name medication that they thought they were taking. a second unanticipated concern is pharmacist liability. considering that the ability for pharmacists to substitute is granted by the state and states have an incentive to keep drug costs down, it might seem intuitive that pharmacists would be shielded from liability in the event that a generic produced differential effects than associated with a brand name drug. in reality, this is not the case. in a survey of its closed pharmacist liability cases in the united states during a ten-year window from january 1, 2002 to december 31, 2011, the insurance provider cna/healthcare providers service organization (hpso) found that 1.9% of its wrong drug dispensation cases involved the failure of a pharmacist to verify the equivalency of a generic prior to substitution and that 3% of its medication mismanagement cases involved the failure of a pharmacist to inform a 183 welner, supra note 171, at 635-37. 184 id. 2015 are bioequivalents really equal? 319 consumer of the change to a generic form of a drug.185 although not constituting a substantial portion of cna/hpso closed pharmacist liability cases, these cases indicate that pharmacists do not enjoy absolute immunity from lawsuits and that they should not be surprised if an injured individual takes action against them for the substitution of a generic drug. 5. limitation of remedies for persons injured by generic psychotropics and competitor liability a final legal cause for concern regarding generic psychotropics is the lack of a path to recovery for individuals injured by them.186 two recent supreme court cases have obscured this path: pliva, inc. v. mensing187 and mutual pharmaceutical co., inc. v. bartlett.188 mensing arose when two individuals filed suit when they developed tardive dyskinesia after receiving a generic version of reglan by way of substitution starting in 2001 and 2002.189 the two individuals sought recovery under a theory of failure to warn, claiming that the generic version of reglan that they were provided did not provide warning that taking the drug for longer could cause tardive dyskinesia.190 in 2004, subsequent to respondents’ 185 cna/health providers service organization, 2013 pharmacist liability: a ten-year analysis, can/hpso 29, 59-60 (2013), https://www.hpso.com/pdfs/db/pharmacist_claim_report_2013.pdf?filen ame=pharmacist_claim_report_2013.pdf&folder=pdfs/db&islivestr=y, archived at http://perma.cc/4rbm-725p (last visited nov. 23, 2014) (explaining that wrong drug dispensation is a legal claim and medication mismanagement is an ethical claim). 186 maren carbon & christoph u. correll, rational use of generic psychotropic drugs, 27 cns drugs 353, 355 (2013). 187 131 s. ct. 2567 (2011). 188 133 s. ct. 2466 (2013). 189 mensing, 131 s. ct. at 2573. reglan is a drug used to treat digestive tract problems; tardive dyskinesia is a severe neurological disorder that impacts movement. td ctr., reglan – side effects and withdrawal symptoms, td ctr. (last visited nov. 23, 2014), http://www.tardivedyskinesia.com/reglan/risk-factors/side-effects.php, archived at http://perma.cc/yq68-zs3c. 190 mensing, 131 s. ct. at 2573. http://dx.doi.org/10.1007/s40263-013-0045-2 320 indiana health law review vol. 12:1 development of tardive dyskinesia, branded reglan’s manufacturer requested approval from the fda to change the drug’s warning label to indicate that treatment should not exceed twelve weeks in length.191 ruling on the basis of preemption, the court held that respondents could not recover under state tort law because for pliva to be in compliance with state tort law, it would have to be out of compliance with federal regulations that required generic medications to utilize the same warning labels as their branded counterparts.192 in essence, pliva did not fail to warn—rather, it was unable to warn.193 similarly, mutual pharmaceutical co., inc. v. bartlett arose when respondent received a prescription for brand name clinoril to treat shoulder pain, but instead was dispensed a generic version.194 shortly after receiving the generic, respondent, a resident of new hampshire, became afflicted with an acute case of toxic epidermal necrolysis that disfigured, disabled, and nearly blinded her.195 at the time, clinoril did not have a warning label apprising consumers of the possibility of toxic epidermal necrolysis.196 respondent filed suit under theories of design-defect and failure to warn, claiming that new hampshire law required drug manufacturers to ensure the safety of the design of their product, which could be established by way of adequate warning about a drug’s potential hazardous effects.197 relying on its holding in mensing, the court again held that federal regulations requiring generic drugs to employ the same warning labels as their branded counterparts preempted stated law, and that mutual could not have changed its warning labels to address the 191 id. at 2572-73. 192 id. at 2577-78. 193 id. 194 mut. pharm. co., inc. v. bartlett, 133 s. ct. 2466, 2472 (2013). clinoril is a non-steroidal anti-inflammatory (nsaid). merck & co., inc., tablets: clinoril®(sulindac), merck, https://www.merck.com/product/usa/pi_circulars/c/clinoril/clinoril_pi.pdf (last visited nov. 23, 2014), archived at http://perma.cc/hg4a-2wz9. 195 bartlett, 133 s. ct. at 2472. 196 id. 197 id. 2015 are bioequivalents really equal? 321 possibility of toxic epidermal necrolysis and still be in compliance with federal regulations.198 mensing and bartlett effectively barred injured consumers from asserting a failure to warn claim against a generic drug manufacturer as the generic manufacturer is reliant upon branded drug manufacturers in terms of what can be put on a warning label; this bar significantly limits the paths to recovery for individuals harmed by generics.199 however, a potential – though controversial – route around the preemption issue could be to sue the branded company when a consumer is injured by a generic drug under competitor liability. 200 applied in this context, competitor liability asserts that brand name manufacturers should be held liable for adverse reactions to generic versions of the drug under theories of negligent misrepresentation and fraud, arguing that due to federal labeling regulations, it is “eminently foreseeable” that a physician may prescribe a generic version of a medication while relying on the warning label of a branded medication.201 though this is a very small minority approach,202 it is indicative of savvy lawyers potentially raising the issue in the future as a way to navigate around mensing and bartlett when clients are injured by psychotropic medications. 198 id. at 2479. 199 carbon & correll, supra note 184, at 355. 200 victor e. schwartz et al., warning: shifting liability to manufacturers of brand-name medicines when the harm was allegedly caused by generic drugs has severe side effects, 81 fordham l. rev. 1835, 1849-53 (2013). 201 id. at 1851. 202 though a very small minority approach, several jurisdictions have allowed a plaintiff to succeed under a theory of duty due to foreseeability: california (conte v. wyeth, inc.), the united states court for the district of vermont (kellogg v. wyeth), and the united states court for the northern district of illinois (dolin v. smithkline beecham corp.). conte v. wyeth, inc., 85 cal. rptr. 3d 299, 320-21 (cal. ct. app., 2008); kellogg v. wyeth, 762 f. supp. 2d 694, 708-09 (d. vt., 2010); dolin v. smithkline beecham corp., no. 12 c 6403, 2014 u.s. dist. lexis 26219, at *16-20 (n.d. ill., feb. 28, 2014). 322 indiana health law review vol. 12:1 v. what should we do? the previous three sections established that generic substitution is a prevalent practice, that generic psychotropics may not always perform equivalently to branded drugs, and that there are a host of legitimate reasons to be concerned about generic substitution schemes as they apply to people in general and specifically to individuals with mental illness. it would be impractical to think that generic substitution could be abolished. as such, this section will provide several brief suggestions for reform to mitigate some of the issues surrounding generic substitution of psychotropic medications. a. eliminate mandatory generic substitution mandatory generic substitution is the most coercive form of substitution in that it does not allow for discretion on the part of pharmacists, physicians, or consumers. this is exacerbated in a scheme that provides for both mandatory substitution and does not require consent or notification—in these instances, consumers do not even realistically have a choice to not take the drug as they may have no knowledge that they have been switched to a generic until they experiences some type of adverse consequence. by allowing for at least the discretion of pharmacists who could face liability if they do not verify the equivalence of a generic to a branded drug, at least one (albeit limited) safeguard is placed against the dispensation of a potentially less effective or even harmful generic psychotropic drug. b. notification and consent another potential solution is to require that all substitution schemes require either consent or notification of patients or their physicians before substitution can take place. in permissive schemes, obtaining consent from either patients or physicians places autonomy back in the hands of patients and their doctors by allowing them to choose if they are comfortable with substitution, consistent with 2015 are bioequivalents really equal? 323 aforementioned constitutional and common law ideals regarding medical decision making.203 while requiring notification does not return the same degree of autonomy to a patient as consent, it does at least allow a doctor to cancel or change a prescription or for a patient to consult with her doctor or decide against taking the generic. c. education in conjunction with the above, educating consumers about generic drugs may help consumers to make informed decisions about whether they are comfortable taking a generic drug. further, education may help dispel myths and alleviate anxiety about taking generic drugs, which is desirable in maintaining similar levels of generic substitution as the ones that currently exist. in a study on the effect of patient education intervention on the acceptance of generic drugs, john-antoni valles and his research team found that over 98% of patients exposed to an education intervention later agreed to receive a generic formulation as compared to a branded one.204 further, the intervention merely consisted of verbal information and handout materials about the advantages and disadvantages of both generic and branded drugs, suggesting that the acceptance of generic drugs can be obtained with relatively little effort.205 d. at the very least, employ the above proposals for psychotropic drugs though the above solutions would be preferable as they would impact all consumers, in the event that the above proposals prove undesirable for the general population, they should at least be provided to individuals taking psychotropic medications, given the specialized concerns of 203 see supra part iii(c)(3). 204 joan-antoni vallès et al., a prospective multicenter study of the effect of patient education on acceptability of generic prescribing in general practice, 65 health pol’y 269, 272 (2003). 205 id. http://dx.doi.org/10.1016/s0168-8510(03)00018-6 324 indiana health law review vol. 12:1 generic substitution with a mentally ill population illustrated in part ii of this article. vi. conclusion every state provides for generic substitution either permissively at a pharmacist’s discretion or as mandated by law. though states approach the concept of generic substitution in a variety of ways, mandating the substitution of generic for brand name drugs and lacking a requirement for patient/physician consent are particularly deleterious approaches. an approach utilizing both of these schemes seems paternalistic. although generic substitution provides an economic benefit to consumers, it is scientifically misguided. though numerous generic versions of medications exist, and though these generics are considered to be “bioequivalent,” the concept of bioequivalence is predicated upon a faulty assumption that similar bioavailability between generic and branded drugs yields similar treatment outcomes. further, the pharmacokinetic studies by which bioequivalence is determined are inherently flawed. these studies utilize homogenous samples of healthy, young males who are likely not representative of the population the test generic is supposed to serve, and employ a single-dose administration that is not reflective of the way that medications are taken in the real world. generic substitution may also give rise to specialized concerns regarding the treatment of mental health disorders. research suggests that for bioequivalent psychotropic medications, though some generic formulations may prove to be similarly effective to brand name medications, many generic formulations of psychotropic medications exhibit inferior performance in comparison to their branded counterparts as well as produce uncomfortable or hazardous side effects that may discourage medication adherence, an integral facet in the treatment of mental illness. this is especially alarming given that rates of treatment compliance for individuals with mental illnesses are already low, and that relapse 2015 are bioequivalents really equal? 325 rates for this population are high. further, though failed treatments for both physical and mental illness may cast a financial burden on society, failed treatment of mental disorders may elicit some unforeseen problems, such as determining culpability for individuals who commit crime while unwittingly taking a generic as opposed to a more effective branded medication, as well as determining tort liability in cases where failed psychotropic medications injure consumers. generic substitution also undermines consumer autonomy. first, it can disrupt patients’ right to make their own medical decisions, a right reflected by the tort concept of medical battery as well as a right championed in such supreme court cases as: cruzan v. director, missouri department of health, griswold v. connecticut, roe v. wade, o’connor v. donaldson, perry v. louisiana, riggins v. nevada, sell v. united states, and washington v. harper.206 second, it may undermine patient autonomy by not reflecting the medication preferences of the american public. although it favors the general concept of generic substitution, it does not endorse a personal preference for generic medications. to respect patient autonomy in medical decision making, ensure the maximum effectiveness of psychotropic medications, and manage deleterious social behaviors by individuals with mental illnesses, mandatory generic substitution of psychotropic drugs should be prohibited. additionally, though generics may be substituted permissively, pharmacists should always be required to obtain patient consent before substituting, and patients should be educated about the similarities and differences 206 see supra part ii(c)(3). it isn’t crazy: why indiana should re-evaluate its mental health related bar exam application questions bailey l. box* i. introduction ............................................................... 473 a. the issue .................................................................... 476 b. roadmap ..................................................................... 478 ii. background ............................................................... 479 a. bar exam applications: character and fitness requirement ...................................................... 479 b. the americans with disabilities act ........................ 482 c. public policy ............................................................... 485 d. indiana: then ............................................................. 486 e. indiana: now .............................................................. 490 f. department of justice’s stance on mental health inquiries ............................................................. 492 g. the national conference of bar examiners’ response ...................................................... 497 iii. analysis .................................................................... 499 a. a look at indiana’s current questions ................... 499 1. question 25 ............................................................ 499 2. question 26 ............................................................. 503 3. question 27 ............................................................. 506 b. summary .................................................................... 507 iv. conclusion ............................................................... 507 * j.d. candidate, 2016, indiana university robert h. mckinney school of law; m.b.a. candidate, 2016, indiana university kelley school of business; b.a., 2012, miami university. for her exemplary work on this note, bailey l. box received the indiana health law review’s best note award for volume xii. http://dx.doi.org/10.18060/3911.0024 2016 473 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions i. introduction any aspiring law student that has asked practicing attorneys what he or she could expect from the practice of law has likely been met with many of the same answers: high stress, long hours, demanding work environments, and tedious work projects. however, despite being aware of some of the less than ideal demands of the legal profession, students continue to go to law school. although law schools have seen a decline in admissions since the recession, as of april 2016, 51,000 students had applied to american law schools for fall 2016 admission.1 while the stressful and tedious aspects of the legal profession certainly do not apply to every attorney at every firm or in every organization, these generalizations are widespread enough, and perhaps for good reason. attorneys “are 3.6 times more likely to suffer from depression than” non-attorneys.2 however, this problem does not just affect practicing attorneys, nor are the terms “high stress,” “demanding,” and “tedious” ones that apply solely to the practice of law – they are prevalent in the law school culture as well. the first year of law school is often a shock to students, because for many it is their first experience with the socratic method of teaching. rather than merely attending a lecture, students are expected to be prepared to be called upon to answer any number of questions about an assigned case or a tangential hypothetical.3 while some professors are much more demanding than others, the adjustment to this method 1 elizabeth olson, minnesota law school, facing waning interest, cuts admissions, n. y. times (may 12, 2016), available at http://www.nytimes.com/2016/05/13/business/dealbook/minnesota-lawschool-facing-waning-interest-cuts-admissions.html [https://perma.cc/ 6e3r-ma2p]. 2 rosa flores & rose marie arce, why are lawyers killing themselves?, cnn u.s. (jan. 20, 2014, 2:42 pm), http:// www.cnn.com/2014/01/19/us/lawyer-suicides/ [https://perma.cc/82f8zx4q]. 3 see generally robert j. rhee, the socratic method and the mathematical heuristic of george pólya, 81 st. john’s l. rev. 881 (2007) (discussing the socratic method). 474 indiana health law review vol. 13:2 of teaching is one that is often met with sweaty palms and a nervous stomach.4 further, the realization that each fellow classmate is your competition – thanks to grading on a strict bell curve – can lead to tense academic environments, and in extreme situations, an unwillingness of students to help one another with coursework. add to this adjustment the pressure of meeting expectations, staying on top of reading assignments, and landing internships that will ideally lead to gainful employment after graduation, it is unsurprising that by the time law students reach the end of their third – which for many is their final – year of law school, 40% of them suffer from signs and symptoms of depression.5 these rates may be even higher at certain institutions, as a recent study conducted at yale law school revealed that 70% of students surveyed reported experiencing mental health challenges during law school.6 unfortunately, students that feel depressed, anxiety ridden, or overly stressed by the pressures of law school may be inclined to think twice before seeking professional treatment for these symptoms.7 in order to be admitted to the bar in any state, graduated law students must not only 4 christopher j. yianilos, the law school breakthrough: graduate in the top 10% of your class, even if you’re not a firstrate student 38 (gina m. cheselka, ed., 2005). 5 g. andrew h. benjamin, reclaim your practice, reclaim your life, trial, dec. 2008, at 30, available at http:// www.lawyerswithdepression.com/wp-content/uploads/2015/02/ trail.howstressandanxietybeccomedepression.december.2008-1.pdf [https://perma.cc/m6up-z9fz]; see also g. andrew h. benjamin et al., the role of legal education in producing psychological distress amount law students and lawyers, 1986 am. b. found. res. j. 225; stephen b. shanfield & g. andrew h. benjamin, psychiatric distress in law students, 35 j. legal educ. 65 (1985); kate mayer mangan, law school quadruples the chances of depression for tens of thousands: some changes that might help, huffington post (aug. 8, 2014) www.huffingtonpost.com/kate-mayer-mangan/law-school-quadruplesdep_b_5713337.html [https://perma.cc/s5we-4aga]. 6 yale law school mental health alliance, falling through the cracks: a report on mental health at yale law school 3 (2014), available at www.scribd.com/doc/252727812/falling-throughthe-cracks#scribd [https://perma.cc/8dhc-6afk]. 7 laura rothstein, law students and lawyers with mental health and substance abuse problems: protecting the public and the individual, 69 u. pitt l. rev. 531, 533 (2008). http://dx.doi.org/10.1086/492145 http://dx.doi.org/10.5195/lawreview.2008.106 2016 475 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions pass the state’s bar exam, 8 but in order to sit for the examination, the student must also pass the state’s character and fitness application.9 the national conference of bar examiners (“ncbe”) provides a set of model character and fitness questions that many states use on their bar applications verbatim.10 taking into account the heightened rate of attorneys who experience depression and the often high-stress nature of both law school and the practice of law, it is not surprising that a majority of states inquire into bar exam applicants’ mental health histories. however, for the applicants that are required to disclose information regarding their mental health histories to the state’s board of examiners, the outcomes that those applicants may face range greatly. in some instances, no additional actions are taken.11 however, there is the possibility that the state bar will request additional information, such as medical records, from the applicant; that it will only allow the applicant to be admitted to the bar on a conditional basis; or the most extreme outcome: a complete denial of admission to the state’s bar.12 8 there is one exception to the requirement that an individual must have successfully passed the bar exam in order to practice law within the state. in wisconsin, students that graduate from the university of wisconsin law school and marquette university law school are admitted to the practice of law by having the school certify their legal compliance and having the board of examiners certify their character and fitness. elizabeth olson, bar exam, the standard to become a lawyer comes under fire, n. y. times (mar. 19, 2015), available at http://www.nytimes.com/2015/03/20/business/dealbook/bar-exam-thestandard-to-become-a-lawyer-comes-under-fire.html?_r=0 [https://perma.cc/65ka-s4d9]. 9 clark v. va. bd. of bar exam’rs, 880 f. supp. 430, 438 (e.d. va. 1995). 10 nat’l conf.of bar exam’rs, request for preparation of a character report 13-14, available at www.ncbex.org/dmsdocument/134 [https://perma.cc/4kb3-yebz]. 11 melody moezzi, lawyers of sound mind?, n.y. times (aug. 5, 2013), available at http://www.nytimes.com/2013/08/06/opinion/lawyersof-sound-mind.html?_r=0. [https://perma.cc/5lv4-5cme]. 12 id. 476 indiana health law review vol. 13:2 a. the issue because of the sensitive nature of questions regarding applicants’ mental health histories, the way in which these inquiries take place has been, and continues to be, a subject of great debate. many bar exam applicants and legal scholars believe that inquiring into bar exam applicants’ mental health histories is not only an unnecessary invasion of an applicant’s privacy, but also a violation of the americans with disabilities act (“ada”).13 in 2011, the southern district of indiana found in the case of aclu of indiana v. individual members of the indiana state board of law examiners that out of the four indiana bar exam application questions regarding applicants’ mental health, only one question – which asked bar applicants to disclose any mental, emotional, or nervous disorders they may have had from age sixteen to present – was a violation of the ada. 14 however, the three remaining questions, which also took a broad look into applicants’ mental health histories, were allowed to stand.15 while the court took a step in the right direction by eliminating one question that looked too expansively into applicants’ mental health histories, it was not a big enough step to ensure indiana’s compliance with title ii of the ada, and to ensure that such inquiries meet the intended goals. in 2016, the indiana board of law examiners asked the following questions of indiana bar exam applicants: 25. within the past five (5) years have you been diagnosed with or have you been treated for bi 13 see, e.g., marian alikhan, the ada is narrowing mental health inquiries on bar applications: looking to the medical profession to decide where to go from here, 14 geo. j. legal ethics 159 (2000); alex b. long, reasonable accommodations as professional responsibility, reasonable accommodation as professionalism, 47 u.c. davis l. rev. 1753 (2014); jon bauer, the character of the questions and the fitness of the process: mental health, bar admissions, and the americans with disabilities act, 49 ucla l. rev. 93 (2001). 14 aclu of ind. v. individual members of the ind. state bd. of law exam’rs, no. 1:09-cv-824-twp-mjd, 2011 wl 4387470, at *13 (s.d. ind. sept. 20, 2011). 15 id. 2016 477 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions polar disorder, depression, or other emotional disorder, schizophrenia, paranoia, or any other psychotic disorder?16 26a. do you have any condition or impairment (including but not limited to, substance abuse, alcohol abuse, or a mental, emotional, or nervous disorder or condition) which in any way currently affects, or if untreated could affect, your ability to practice law in a competent manner?17 26b. are the limitations or impairments caused by your mental health condition or substance abuse problem reduced or ameliorated because you receive ongoing treatment (with or without medication) or because you participate in a monitoring program?18 27. have you ever raised the issue of consumption of drugs or alcohol or the issue of a mental, emotional, nervous, or behavioral disorder or condition as a defense, mitigation, or an explanation for your actions in the course of any administrative or judicial proceeding or investigation, any inquiry or other proceeding, or any proposed termination by any educational institution, employer, government agency, professional organization or licensing authority?19 as they stand, not all of the indiana state bar exam application questions pertaining to applicants’ mental health focus on the applicants’ behavior or conduct that could impact their ability to practice law. instead, the questions posed to bar exam applicants focus solely on their mental health conditions. the expansive scope of these questions may also 16 ind. supreme court bd. of law exam’rs, character & fitness questionnaire, application information (2016), available at https://myble.courts.in.gov/browseapplication.action?id=9 (select “browse form” beside “character and fitness questionnaire,” then click “general questions” in the dropdown bar) (last visited apr. 20, 2016). 17 id. 18 id. (to see the text of this question, respond “yes” to question 26a). 19 id. 478 indiana health law review vol. 13:2 serve as a deterrent for individuals with symptoms of mental illness to seek help during their law school years, or as a deterrent for those who have been diagnosed with mental illness from truthfully disclosing information related to their mental health histories. the negative ramifications of not having properly tailored questions regarding applicants’ mental health histories not only have the potential to impact the applicants themselves, but also the applicants’ coworkers, clients, and the indiana legal community as a whole. b. roadmap although the questions posed to indiana bar exam applicants regarding their mental health histories are far less intrusive than they were prior to the court’s holding in aclu of indiana, as they are currently written, the questions are still too broad and risk infringing upon the privacy afforded to each applicant under title ii of the ada. this note will address the importance of the indiana board of law examiners re-evaluating the way in which indiana looks into bar exam applicants’ mental health histories, and shifting its inquiry to one that is more focused on the conduct of the applicants rather than solely on their conditions. first, this note will provide background on the character and fitness requirements that bar exam applicants must meet, title ii of the ada, and why many character and fitness questions related to mental health are challenged as a violation of title ii of the ada. the evolution of indiana’s character and fitness questions related to mental health will be reviewed, and a february 5, 2014 letter from the united states department of justice (“doj”) in regard to its stance on states’ inquiries into applicants’ mental health histories will be discussed. next, current questions that the indiana board of law examiners is posing to its applicants will be analyzed to determine how well applicants are being protected under the rights afforded to them by title ii of the ada. finally, this note will focus on the ways in which the indiana bar and its applicants may benefit from a reevaluation of the current character and fitness questions related to mental health. 2016 479 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions ii. background a. bar exam applications: character and fitness requirement while the academic requirements a bar exam applicant must meet to become licensed in any given state in america have evolved over the years, the prerequisite that an applicant be one of virtue has been a constant.20 however in today’s society, boards of law examiners are looking for far more than virtue alone in the applicants hoping to become licensed attorneys. rather, these licensing boards are looking for a thorough assessment of an individual’s character and fitness.21 the importance in ensuring that an attorney meets requisite character and fitness standards lies in both “protecting the public” and in “preserving professionalism.”22 if an attorney is affected by an untreated mental or emotional illness, he or she may pose a possible risk to clients, colleagues, and the public, because some mental illnesses, if not properly treated, can negatively impact an individual’s ability to competently and skillfully practice law.23 state bar authorities require applicants to meet certain character and fitness criteria in order to sit for the state’s bar examination.24 however, states’ definitions of “fitness” are not unanimous, and the criteria upon which they use to 20 deborah l. rhode, moral character as a professional credential, 94 yale l.j. 491, 496 (1985). 21 aaron m. clemens, facing the klieg lights: understanding the “good moral character” examination for bar applicants, 40 akron l. rev. 255, 257 (2007) (discussing that state bar examiners often look into several aspects of an applicant’s past to determine whether the applicant has good moral character, such as his or her “financial [responsibility], past criminal history, mental illness and treatment, substance abuse, lack of academic integrity, and failure to cooperate with bar examiners. . . .”). 22 rhode, supra note 20, at 507-512. 23 jennifer mcpherson hughes, suffering in silence: questions regarding an applicant’s mental health on bar applications and their effect on law students needing treatment, 28 j. legal prof. 187, 188 (2004). 24 marcus ratcliff, the good character requirement: a proposal for a uniform national standard, 36 tulsa l.j. 487, 492 (2000). http://dx.doi.org/10.2307/796236 480 indiana health law review vol. 13:2 evaluate applicants to determine whether they meet the established definition vary widely on a state-by-state basis.25 although the criteria and questions posed to applicants may vary, the methods in which these questions are posed are relatively similar. in most states, the character investigation takes place through a questionnaire completed by each applicant; however, some states have an added step requiring each candidate to undergo an in-person interview.26 for an individual to be admitted to practice law in indiana, the applicant has the “burden of proving that he or she possesses the requisite good moral character and fitness to practice law.” 27 in indiana, “[t]he term ‘good moral character’ includes, but is not limited to, the qualities of honesty, fairness, candor, trustworthiness, observance of fiduciary responsibility, and of the laws of this state and of the united states, and a respect for the rights of other persons and things, and the judicial process.”28 the term “fitness” relates to the “physical and mental suitability of the applicant to practice law. . . .”29 in addition to completing the character and fitness questionnaire, every indiana bar exam applicant must undergo an in-person character interview by a member of the committee or a member designated by the board of law examiners.30 in clark v. virginia board of bar examiners, an action brought by a 1993 graduate of george mason university law school against the virginia board of bar examiners, the united states district court in the eastern district of virginia examined how states asked bar exam applicants about their mental health histories.31 the court explained that states handled mental health inquiries in the following ways: (1) not looking into applicants’ mental health histories, (2) asking only about hospitalization or institutionalization 25 id. 26 id. 27 in. st. admis. and disc. r. 12 § 2 (2014). 28 id. 29 id. 30 id. § 4. 31 clark v. va bd. of bar exam’rs, 880 f.supp. 430, 438-440 (e.d. va. 1995). 2016 481 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions for mental illness, and (3) inquiring broadly into applicants’ treatment and/or counseling for mental and emotional disorders or illnesses.32 due to the vast differences in how states question applicants about their mental health histories, passing muster for one state’s character and fitness examination does not mean that an applicant will subsequently be able to meet the standards of another state, even if he or she has been proven competent to practice. in one instance, a harvard law school graduate, who had been diagnosed with bipolar disorder as a law student, was admitted to practice in both new york and massachusetts.33 however, when she applied to the connecticut bar in the mid-1990s, she disclosed her mental illness and was not recommended for admission.34 it took a lengthy judicial process for her to gain conditional admission to the connecticut bar.35 in order to maintain her conditional admission status, she was required to provide the connecticut bar examining committee with a “doctor’s report and affidavit” twice a year to affirm that she was fit for the practice of law in connecticut. 36 the conditional admission status placed on this applicant, who had been previously admitted to bars in two different states, lasted for nine years.37 the individual that endured nine years of being only conditionally admitted to practice in the state of connecticut is kathleen flaherty.38 after the tragic shooting that took place at sandy hook elementary school in newton, connecticut in 2013,39 ms. flaherty was appointed to the 32 id. 33 moezzi, supra note 11; debra cassens weiss, lawyer says her experience with bipolar disorder is reason for appointment to sandy hook commission, aba j. (jan. 15, 2013, 6:11 pm), http:// www.abajournal.com/news/article/lawyer_says_her_experience_with_bip olar_disorder_is_reason_for_appointment_/ [http://perma.cc/sbl9ur85]. 34 moezzi, supra note 11. 35 id. 36 id. 37 id. 38 id. 39 on december 14, 2012, 20-year old adam lanza entered sandy hook elementary school and killed 20 children and six adult school 482 indiana health law review vol. 13:2 sandy hook advisory commission by connecticut’s governor, dannel p. malloy. 40 ms. flaherty credits her personal experience with bipolar disorder as to why she was personally asked to serve on the commission.41 instances such as these raise the question as to whether there is a correct way to ask applicants about their mental health histories, or if they should be inquired into at all. had ms. flaherty been deterred from seeking admission to connecticut’s bar based upon her history of mental health related issues, or had she been unwilling to meet the extra requirements placed upon her to maintain her conditional admittance status that lasted for almost a decade, the state of connecticut likely would not have benefitted from her knowledge, experience, and expertise in the wake of an unspeakable tragedy that stemmed from one individual’s struggle with mental illness.42 the line between adequately screening for individuals that may be a harm to themselves or to others based upon their mental health histories and violating the rights afforded to applicants under title ii of the ada is a fine one. thus, it is of the utmost importance for indiana to take an objective look at the impact that the mental health inquiries on the character and fitness portion of its application are having on the individuals seeking admittance to the indiana bar. b. the americans with disabilities act the ada, enacted in 1990, was created “to provide a clear and comprehensive national mandate for the elimination of employees. see james barron, nation reels after gunman massacres 20 children at school in connecticut, n.y. times (dec. 14, 2012) http://www.nytimes.com/2012/12/15/nyregion/shooting-reported-atconnecticut-elementary-school.html [perma.cc/e5r4-h288]. 40 id. 41 weiss, supra note 33. 42 alison leigh cowan, adam lanza’s mental problems ‘completely untreated’ before newton shootings, report says, n.y. times (nov. 21, 2014), http://www.nytimes.com/2014/11/22/nyregion/before-newtownshootings-adam-lanzas-mental-problems-completely-untreated-reportsays.html [perma.cc/3m7v-y6hu] (discussing that adam lanza went untreated for “psychiatric and physical ailments like anxiety and obsessive-compulsive disorder”). 2016 483 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions discrimination against individuals with disabilities.”43 prior to its enactment, individuals that were discriminated against based upon their disabilities were not afforded the same federal protection against discrimination that individuals who experienced discrimination based upon their “race, sex, religion, national origin, and age had.”44 since the ada went into effect over twenty-five years ago, numerous federal and state court decisions have discussed the interplay between the ada and state bar examiners’ inquiries into applicants’ mental health histories.45 the ada serves to protect individuals with disabilities. the act defines “disability,” with respect to an individual, as (1) “a physical or mental impairment that substantially limits one or more major life activities of such individual;” (2) “a record of such an impairment;” or (3) “being regarded as having such an impairment.” 46 title ii of the ada was enacted to prohibit discrimination against individuals by public entities, as it states that “no qualified individual with a disability shall, by reason of such disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of a public entity, or be subjected to discrimination by any such entity.” 47 “public entity” is defined as “any state or local government” or “any department, agency, special purpose district, or other instrumentality of a state or states or local government. . . .”48 regulations, such as those discussed below, were put into place to “indicate that coverage extends to the activities of the state judicial branch and to state licensing programs.”49 state bar examiners are widely considered to act as an arm of the state judiciary, and thus are covered by the 43 42 u.s.c. § 12101(b)(1) (2016). 44 cary lacheen, using title ii of the americans with disabilities act on behalf of clients in tanf programs, 8 geo. j. on poverty l. & pol’y 1, 37 (2001). 45 bauer, supra note 13, at 125-126. 46 42 u.s.c. § 12102(1) (2016). 47 id. § 12132. 48 id. § 12131(1). 49 bauer, supra note 13, at 128. 484 indiana health law review vol. 13:2 requirements in title ii.50 more specifically, the ada has been held to apply to questions asked to applicants by legal licensing boards.51 the ada clearly states that a public entity may not “directly or through contractual or other arrangements, utilize criteria or methods of administration . . . [t]hat have the effect of subjecting qualified individuals with disabilities to discrimination on the basis of disability.”52 in specific reference to licensing, “[a] public entity may not administer a licensing or certification program in a manner that subjects qualified individuals with disabilities to discrimination on the basis of a disability.”53 further, in the course of administering such licensing or certification programs, “a public entity shall not impose or apply eligibility criteria that screen out or tend to screen out an individual with a disability or any class of individuals with disabilities from fully and equally enjoying any service, program, or activity, unless such criteria can be shown to be necessary.”54 although a public entity is allowed to put in place certain safety requirements to ensure “safe operation of its services, programs, or activities,” such requirements must be “based 50 id.; see also aclu of ind. v. individual members of the ind. state bd. of law exam’rs, no. 1:09-cv-824-twp-mjd, 2011 wl 4387470, at *5 (s.d. ind. sept. 20, 2011); ware v. wyo. bd. of law exam’rs, 973 f.supp 1339, 1352 (d. wyo. 1997); ellen s. v. fla. bd. of bar exam’rs, 859 f. supp. 1489, 1493 n. 4 (s.d. fla. 1994). 51 see, e.g., clark v. va. bd. of law exam’rs, 880 f. supp. 430, 446 (e.d. va. 1995) (holding that a question inquiring into applicants’ mental health was too broadly worded and discriminated against disabled applicants); ellen s., 859 f. supp. at 1493-94 (holding that florida’s bar exam application questions pertaining to mental health discriminate against plaintiffs by placing additional burdens on them because of their disability); application of underwood, no. bar-93-21, 1993 wl 649283, at *112 (me. dec. 7, 1993) (holding that requirement that maine bar applicants answer mental health questions “discriminates on the basis of disability and imposes eligibility criteria that unnecessarily screen out individuals with disabilities.”). 52 28 c.f.r. § 35.130(b)(3)–(b)(3)(i) (2016). 53 id. § 35.130(b)(6). 54 id. § 35.130(b)(8). 2016 485 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions on actual risks, not on mere speculation, stereotypes, or generalizations about individuals with disabilities.”55 if bar exam applicants feel that they have been discriminated against in violation of the ada, there are several remedies available to them. first, the applicant may file an administrative complaint within 180 days of the discrimination occurring.56 such complaint may be filed with an agency enumerated within the title ii regulations or with the department of justice.57 alternatively, an applicant may file a lawsuit.58 thus, if states’ board of law examiners do not take it upon themselves to ensure that the methods being used to inquire into applicants’ mental health histories are compliant with title ii of the ada, it will be left for a court of law to determine, such as it was in aclu of indiana, and in several other jurisdictions throughout the country.59 c. public policy because of the number of law students and attorneys that experience depressive symptoms and mental health related issues, the public policy reasons behind many states inquiring into applicants’ mental health histories are well taken. safeguards need to be put in place that will ensure indiana bar applicants are mentally fit to practice law, both for their own safety and wellbeing, and for the protection of those that they represent and interact with in a professional capacity. however, the way in which the indiana board of law examiners chooses to screen applicants is crucial, both to reduce the number of false positives – applicants that are incorrectly flagged as being potentially unfit to practice law – during an application cycle and to protect the rights afforded to each applicant through title ii of the ada. this 55 id. § 35.130(h). 56 id. § 35.170(b). 57 id. § 35.170(c). 58 id. § 35.172(d). 59 see, e.g., clark v. va. bd. of law exam’rs, 880 f. supp. 430, 446 (e.d. va. 1995); ellen s. v. fla. bd. of bar exam’rs, 859 f. supp. 1489, 1493 n. 4 (s.d. fla. 1994); application of underwood, no. bar-93-21, 1993 wl 649283, at *1 (me. dec. 7, 1993). 486 indiana health law review vol. 13:2 will not only be beneficial for the applicants, but will also preserve the board of law examiners’ time and resources during the application cycle. if there is a more effective set of questions in place, the time and resources spent evaluating applicants that have been falsely identified as being unfit for the practice of law will be greatly reduced. additionally, apart from the benefits that the indiana board of law examiners will experience from indiana revisiting its mental health related inquiries, there are also benefits for the applicants themselves. the broad nature of indiana’s current questions may deter individuals from attending law school out of fear of having to disclose their mental health status. it may deter law students who are experiencing mental health related symptoms from seeking treatment. moreover, indiana’s current questions may cause students who have been diagnosed with or are being treated for mental illness from being truthful in their disclosures on the bar exam application. d. indiana: then in 2009, plaintiffs – students at what is now robert h. mckinney school of law in indianapolis indiana, and a 2007 valparaiso university school of law graduate – filed a complaint against the indiana board of law examiners over four bar exam questions that they believed were too broad.60 amanda perdue, the original sole plaintiff to this case, was an illinois attorney who hoped to sit for the bar exam in indiana.61 perdue had been diagnosed with anxiety disorder and posttraumatic stress disorder and she had undergone professional treatment for these conditions.62 upon applying to sit for the indiana bar exam in 2008, perdue, like all applicants, completed the character and fitness portion of the application.63 because of her mental health history, perdue 60 aclu of ind. v. individual members of the ind. state bd. of law exam’rs, no. 1:09-cv-824-twp-mjd, 2011 wl 4387470 (s.d. ind. sept. 20, 2011). 61 perdue v. individual members of ind. state bd. of law exam’rs, 266 f.r.d. 215, 217 (s.d. ind. 2010). 62 id. 63 id. 2016 487 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions responded “yes” to question 23, which inquired into whether she had been diagnosed or treated for any type of emotional, mental, or nervous disorder from the age of 16 to present.64 perdue’s affirmative response triggered the indiana board of law examiners to request additional information regarding her mental health conditions and to refer perdue to the judges and lawyers assistance program (“jlap”).65 jlap is a program that was created in 1997 to provide help to judges, attorneys, and law students who experience physical or mental disabilities that result from disease, chemical dependency, mental health problems, or age, which may impair these individuals’ ability to practice in a competent and professional manner.66 jlap provides assistance to indiana attorneys and law students in several ways, including providing them with information and connecting them to resources that can help organize an intervention.67 the indiana board of law examiners has the ability to refer any applicant to jlap if it is concerned about the applicant’s mental fitness.68 in determining whether it will refer an applicant to the program, many factors are taken into consideration, including: “how recent the mental health issue was; whether it’s episodic; whether it required continuing treatment; whether it resulted in hospitalization or arrest; and whether it resulted in loss of employment or licensing.”69 however, while the indiana board of law examiners has the ability to refer any individual to jlap that it deems in need of jlap’s services, the individuals are not required to oblige. perdue declined to consent to the requests and referral to jlap.70 instead, she subsequently withdrew her application and filed suit against the indiana board of law 64 aclu of ind., 2011 wl 4387470 at *4. 65 perdue, 266 f.r.d. at 217. 66 about jlap, courts.in.gov, https://secure.in.gov/judiciary/ijlap/ 2361.htm [perma.cc/ud77-jtkb] (last visited apr. 20, 2016). 67 id. 68 aclu of ind., 2011 wl 4387470, at *3. 69 id. 70 perdue, 266 f.r.d. at 217. 488 indiana health law review vol. 13:2 examiners.71 the lawsuit, which was initially brought by perdue, eventually became a class action with the american civil liberties union (“aclu”) being appointed as the class representative.72 at the time perdue filed her original complaint against the indiana board of law examiners, applicants applying for admission to the indiana bar were asked the following four questions regarding their mental health histories: 22. have you been diagnosed with or have you ever been treated for bi-polar disorder, schizophrenia, paranoia or any other psychotic disorder? 23. from the age of 16 years to the present, have you been diagnosed or treated for any mental, emotional, or nervous disorders? 24. do you have any condition or impairment (including, but not limited to, substance abuse, alcohol abuse, or a mental, emotional, or nervous disorder or condition) which in any way currently affects, or if left untreated could affect, your ability to practice law in a competent and professional manner? 25. if your answer to question 24 is affirmative, are the limitations or impairments caused by your mental health condition or substance abuse problem reduced or ameliorated because you receive ongoing treatment (with or without medication) or because you participate in a monitoring program?73 if an applicant answered affirmatively to questions 22-25, he or she was required to complete a b-1 form, which sought more information about the applicant’s condition, diagnosis, 71 id. 72 id. 73 aclu of ind., 2011 wl 4387470, at *2. 2016 489 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions treatment, and providers. 74 these applicants were also required to sign a general release of information.75 the court summarized its duty in this case as “[resolving] whether the challenged questions are ‘necessary’ to determine whether the bar applicant poses a ‘direct threat’” to the health and safety of themselves and of others. 76 ultimately, the court held that only one of these questions was in violation of the ada – question 23 – which the court called “possibly the most expansive bar application question in the country.”77 it was reasoned to be too broad, to lead to too many false positives, and to have chosen an arbitrary time frame that was not a good indicator of an individual’s current mental fitness to practice law.78 the other three questions – question 22, which asked about applicants’ histories of bi-polar disorder, schizophrenia, paranoia, or other psychotic disorders, and questions 24 and 25, which asked applicants about any condition or impairment that “currently affects,” or if “left untreated could affect,” his or her ability to practice law competently and professionally – however, were allowed to stand.79 question 22, although it had no temporal limitation, was reasoned to involve “serious” mental illnesses that could be recurring in nature.80 because of the likelihood that these enumerated conditions could reappear during an applicant’s lifetime, its broad nature was not found to violate the ada.81 questions 24 and 25 were not considered to violate the ada because the court considered them “narrowly focused on the current time period” and focused on “the applicant’s current ability to practice law.”82 however, in its opinion, the court looked at each question and considered its compliance with the ada in depth. ultimately, although it only struck down one question as 74 id. at *3. 75 id. 76 id.at *8. 77 id. at *9. 78 id. at *9. 79 id. at *8-13. 80 id. at *7. 81 id. at *9. 82 id. at *10. 490 indiana health law review vol. 13:2 being too broad to comply with the ada and allowed the remaining three questions to stand, the court did note that possibly no set of bar exam questions could perfectly meet both the need to screen problematic bar applicants and to “[respect] applicants’ privacy.”83 the court is likely correct in its stance that there may never be a perfectly tailored set of questions that precisely meets each need that the character and fitness portion of states’ bar exam applications are intended to serve. even the most compliant set of questions will not perfectly screen all applicants, nor will all applicants necessarily respond truthfully to each question. even so, this should not serve as a rationale for states to rest on their laurels and not re-evaluate the mental health related questions posed to bar exam applicants on a consistent basis. thus, although the court struck one extremely broad question, indiana should continually evaluate the questions it asks its bar exam applicants, as such re-evaluation is beneficial for the state, applicants themselves, and the clients and colleagues the applicants will work with. e. indiana: now as discussed supra, the indiana board of law examiners currently asks indiana bar exam applicants the following questions, which have slightly changed since the court’s decision in aclu of indiana: 25. within the past five (5) years have you been diagnosed with or have you been treated for bipolar disorder, depression, or other emotional disorder, schizophrenia, paranoia, or any other psychotic disorder?84 26a. do you have any condition or impairment (including but not limited to, substance abuse, alcohol abuse, or a mental, emotional, or nervous disorder or condition) which in any way currently affects, or if untreated could affect, 83 id. at *13. 84 ind. supreme court bd. of law exam’rs, supra note 16. 2016 491 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions your ability to practice law in a competent and professional manner?85 26b. are the limitations or impairments caused by your mental health condition or substance abuse problem reduced or ameliorated because you receive ongoing treatment (with or without medication) or because you participate in a monitoring program?86 27. have you ever raised the issue of consumption of drugs or alcohol or the issue of a mental, emotional, nervous, or behavioral disorder or condition as a defense, mitigation, or an explanation for your actions in the course of any administrative or judicial proceeding or investigation, any inquiry or other proceeding, or any proposed termination by an educational institution, employer, government agency, professional organization or licensing authority?87 comparing these questions to those that were challenged in aclu of indiana, it is clear that some adjustments have been made. of course, former question 23, which asked whether an applicant had been diagnosed with or treated for any mental, emotional, or nervous disorders – which was ultimately struck down in aclu of indiana – is no longer posed to applicants. 88 additionally, current question 25 places temporal limitations on former question 22 by only requiring applicants to disclose whether they have been diagnosed with or treated for the enumerated disorders within the past five years. 89 question 26a remains substantively identical to former question 24. further, indiana has added question 27, which asks whether 85 id. 86 id. 87 id. 88 aclu of ind. v. individual members of the ind. state bd. of law exam’rs, no. 1:09-cv-824-twp-mjd, 2011 wl 4387470, at *13 (s.d. ind. sept. 20, 2011). 89 ind. supreme court bd. of law exam’rs, supra note 16. 492 indiana health law review vol. 13:2 applicants have ever, among other things, used their mental, emotional, nervous, or behavioral disorders as an explanation or defense in one or more of several settings, such as judicial proceedings or investigations.90 as seen above, the indiana board of law examiners has amended its questions over and above the standard the court in aclu of indiana determined would bring the questions into compliance with the ada. however, as they stand, indiana’s questions still place additional criteria upon applicants based on their mental health histories. while placing additional criteria upon applicants alone is not a violation of the ada, it must be shown that such criteria are necessary to the board of law examiners’ licensing function and are not merely additional criteria placed on individuals based on “mere speculation, stereotypes, or generalizations.”91 f. department of justice’s stance on mental health inquiries in 2011, the bazelon center for mental health law92 filed complaints against the louisiana bar examiners.93 these complaints were made on behalf of two louisiana attorneys who applied for admission to the louisiana bar; however, because of their mental health histories, diagnoses, and treatments, these individuals were not granted full access to the louisiana bar but instead were admitted only on a 90 id. 91 28 c.f.r. § 35.130 (h) (2016). 92 the judge david l. bazelon center for mental health law is a national legal-advocacy organization representing people with mental disabilities. who we are, judge david l. bazelon center for mental health, http://www.bazelon.org/who-we-are.aspx [https://perma.cc/ p5f2-wrta] (last visited apr. 20, 2016). 93 letter from jocelyn samuels, acting assistant attorney general, to bernette j. johnson, louisiana supreme court chief justice, elizabeth s. schell, executive director of louisiana supreme court committee on bar admissions, and charles b. plattsmier, chief disciplinary counsel of the louisiana attorney disciplinary board (feb. 5, 2014) [hereinafter letter from jocelyn samuels], available at http://www.bazelon.org/linkclick.aspx?fileticket=7fvthyxzawm%3d&t abid=698 [https:// perma.cc/dw6z-yuyn]. 2016 493 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions “conditional” basis.94 in response to the complaints filed on behalf of these individuals, the doj launched an investigation of louisiana’s attorney licensure system to determine whether it was compliant with title ii of the ada.95 at the time of this investigation, the louisiana bar examiners required each prospective applicant to request that the ncbe prepare a character report.96 to obtain an ncbe character report, a prospective applicant must, among other things, answer twenty-eight questions – four of which deal with an applicant’s mental health.97 at the time, the ncbe posed the following questions to each applicant regarding his or her mental health histories: 25. within the past five years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder? 26a. do you currently have any condition or impairment (including, but not limited to, substance abuse, alcohol abuse, or a mental, emotional, or nervous disorder or condition) which in any way currently affects, or if untreated could affect, your ability to practice law in a competent and professional manner? 26b. if your answer to question 26(a) is yes, are the limitations caused by your mental health condition. . . reduced or ameliorated because you receive ongoing treatment (with or without medication) or because you participate in a monitoring program? 27. within the past five years, have you ever raised the issue of consumption of drugs or alcohol or the issue of a mental, emotional, nervous, or behavioral disorder or condition as a defense, mitigation, or explanation for your actions in the course of any administrative or 94 id. at 3. 95 id. 96 id. 97 id. at 4-5. 494 indiana health law review vol. 13:2 judicial proceeding or investigation; any inquiry or other proceeding; or any proposed termination by an educational institution, employer, government agency, professional organization, or licensing authority?98 when applicants responded affirmatively to questions 25 or 26 of the ncbe character report, they were required to complete a form authorizing each of their treatment providers to release information relating to their mental illness, including copies of medical records.99 additionally, the applicants that responded affirmatively to these questions were required to provide detailed information about the condition and any treatment they had received for it.100 applicants that responded affirmatively to question 27 were required to thoroughly explain the situation through a supplement to the application; however, an affirmative response to question 27 did not result in additional forms requiring treating professionals’ authorizations or a description of the condition.101 at the conclusion of its investigation into the louisiana bar examiners’ methods for inquiring into applicants’ mental health histories, the doj concluded that the four questions asked by the louisiana bar examiners via the ncbe questions were in violation of title ii of the ada.102 the doj deemed questions 25, 26a, 26b and 27 of the ncbe request for preparation of a character report to be a violation of the ada because they did not serve the purported goal of screening out applicants that may not be mentally fit for the practice of law.103 instead, the doj stated that these questions served as “eligibility criteria that screen out or tend to screen out individuals with disabilities based on stereotypes and assumptions about their disabilities and are not necessary to assess the applicants’ fitness to practice 98 id. at 5. 99 id. at 6. 100 id. 101 id. 102 id. at 18. 103 id. 2016 495 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions law.”104 it also found that the following additional “forms of discrimination flow from the use of [these questions]”: 1) imposing additional burdens on applicants with disabilities who were required to provide additional reports and/or medical records; 2) making admissions recommendations on the existence of a mental health disability as opposed to conduct; 3) placing burdensome condition upon an applicants’ legal licenses because of a mental health diagnosis and/or treatment; 4) imposing additional financial burdens on applicants and attorneys with disabilities, and 5) failing to protect the conditional medical information of applicants with disabilities.105 in recommending ways to move forward and bring its questions regarding applicants’ mental health histories into compliance with title ii of the ada, the doj, among other things, urged louisiana to discontinue its use of “[q]uestions 25 – 27 of the ncbe request for preparation of a character report as the questions were currently written.”106 the doj also called for a modification of the louisiana supreme court rules to allow for the louisiana bar examiners to screen applicants using conduct-based methods. 107 the doj reasoned that a conduct-based method of inquiry, which would focus on specific behaviors that applicants had exhibited, would more successfully ensure that an individual’s mental health diagnosis or treatment was not the basis for being referred for an additional evaluation during the application process.108 104 id. 105 id. 106 id. at 31. 107 id. at 22. 108 id. 496 indiana health law review vol. 13:2 the louisiana supreme court and the doj entered into a settlement agreement in august 2014.109 the settlement agreement clearly stated that the louisiana supreme court disagreed with the conclusions reached by the doj in its letter.110 the louisiana supreme court also denied that any applicants for licensure or conditionally admitted attorneys were discriminated against. 111 however, the statement affirmed that the louisiana supreme court was willing to work with the doj to ensure that its questions were in complete compliance and to ensure a fair application process for applicants.112 despite its explicit disagreement with the doj’s stance on its questions, louisiana agreed to cease using the standard ncbe questions 25 – 27 as they were written at the time that the questions were challenged.113 additionally, it was agreed that individuals involved in admissions to the louisiana bar will “[n]ot recommend or impose conditional admission solely on the basis of mental health diagnosis or treatment.”114 however, it is important to note that the doj is an executive department of the united states government.115 while it has power over all criminal prosecutions and civil suits in which the united states has an interest, 116 its opinion on louisiana’s bar exam questions does not bind state supreme courts or state agencies that choose character and fitness questions. although the doj deemed the ncbe questions, as they were written at the time, a violation of title ii of the ada, and an agreement was entered to cease use of those questions, states that continue to use them are not in violation of the law. for the questions to be deemed a violation of the ada in a particular state, it will take an 109 press release, settlement agreement between the united states of america and the louisiana supreme court under the americans with disabilities act (aug. 15, 2014), available at http:// www.ada.gov/louisiana-supreme-court_sa.htm [perma.cc/un6n-p4tb]. 110 id. 111 id. 112 id. 113 id. 114 id. 115 about doj, u. s. dep’t. of just.; available at https:// www.justice.gov/about [https://perma.cc/5lzk-yd8t] (last visited apr. 20, 2016). 116 id. 2016 497 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions applicant to that state’s bar who feels he or she has been discriminated against to bring action in court, and for the court to hold that the questions run afoul of the law. therefore, because states vary greatly in how they inquire into applicants’ mental health histories, even if an applicant challenges a state’s questions in a court of law, the decisions rendered by that jurisdiction regarding whether the questions are compliant with title ii of the ada may differ between jurisdictions, even if the two states use essentially the same questions. because of this, it is unlikely that there will be a uniform standard of questions on a state-by-state basis related to applicants’ mental health histories until such case reaches the u.s. supreme court. g. the national conference of bar examiners’ response the ncbe amended questions 25 – 27 to the following: 25. within the past five years, have you exhibited any conduct or behavior that could call into question your ability to practice law in a competent, ethical, and professional manner? 26a. do you currently have any condition or impairment (including, but not limited to, substance abuse, alcohol abuse, or a mental, emotional, or nervous disorder or condition) that in any way affects your ability to practice law in a competent, ethical, and professional manner? 26b. if your answer to 26(a) is yes, are the limitations caused by your condition or impairment reduced or ameliorated because you receive ongoing treatment or because you participate in a monitoring or support program? 27. within the past five years, have you asserted any condition or impairment as a defense, in mitigation, or as an explanation for your conduct in the course of any inquiry, any investigation, or any administrative or judicial proceeding by an educational institution, government agency, professional organization, or licensing authority, or in connection with an 498 indiana health law review vol. 13:2 employment disciplinary or termination procedure?117 if an applicant answers “yes” to either questions 26(a) or (b), the applicant must also complete a separate form 7 and 8 for each service provider who has treated the applicant.118 form 7 is an authorization to release medical information – without limitation – in relation to mental illness and the use of drugs and alcohol to the ncbe.119 form 8 requires a description of the condition or impairment, any treatment “program that includes monitoring or support,” and contact information for attending physicians, counselors, and hospitals or institutions.120 the ncbe altered questions 25 and 26 to a conduct-based inquiry. instead of asking whether the applicant has been diagnosed with or treated for bipolar disorder, schizophrenia, paranoia, or another psychotic disorder within the past five years,121 question 25 now asks whether any such diagnosis affects the applicant’s ability to competently, ethically, and responsibly practice law.122 additionally, the ncbe removed the “or if left untreated” language from question 26, which allows the question to now focus solely on the current impact that an applicant’s mental, emotional, or nervous disorder or condition is having on his or her ability to practice law competently and professionally.123 it is clear, as question 27 remains unchanged, that the ncbe did not fully amend its questions to follow the doj’s opinions. the doj considers question 27 to be unnecessary and in violation of the ada. however, because the doj’s opinions in the louisiana matter are not binding authority, there was no duty for the ncbe to do so. 117 nat’l conf. of bar exam’rs, supra note 10. 118 id. at 14. 119 id. at 28. 120 id. at 29. 121 letter from jocelyn samuels, supra note 93. 122 nat’l conf. of bar exam’rs, supra note 10. 123 id. 2016 499 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions iii. analysis although as a whole indiana’s bar exam application questions related to applicants’ mental health histories are not as broad as they were prior to the aclu of indiana decision, they are still too broad to afford applicants the protections they are provided under title ii of the ada. while the doj has made its stance clear and the ncbe has amended its own questions to be more conduct-focused, it is up to each state to decide whether or not to adopt these questions and how to interpret them. ultimately, it is the indiana supreme court that is responsible for ensuring the state’s licensing practices do not violate the ada. however, for a court of law to intervene and scrutinize a state’s licensing practices, it first takes an individual with the belief that he or she has suffered discrimination by the state bar examiner on the basis of disability to bring suit. it is likely that this decision is not one that will be made lightly by such applicant, as it takes an extreme determination and in some instances, such as in the case of kathleen flaherty, a willingness to allow an in depth look into the applicant’s mental health records, to challenge the way in which a state is screening its bar exam applicants. a prudent state should constantly review its own questions and procedures to determine if it is best meeting its own needs and the needs of applicants rather than waiting for a discriminated individual to bring suit in a court of law. however, unfortunately, it does not seem that this is the approach that indiana has taken. the ncbe amended its model questions to be more conduct-focused; however, as discussed supra, although these questions do not necessarily fully comply with the stance taken by the doj, it shows progress. indiana, however, continues to use the former ncbe model questions – those which the doj has opined are a violation of the ada – to screen its applicants. a. a look at indiana’s current questions 1. question 25 indiana’s current question 25 – which is similar in wording to the former question 22 – now requires individuals 500 indiana health law review vol. 13:2 who have been diagnosed with or have been treated for what the court in aclu of indiana deemed a “serious condition” to only disclose that information if such diagnosis or treatment has occurred within the past five years. the court in aclu of indiana allowed former question 22 to stand as it was written, despite the fact that it had no temporal limit because the types of conditions being asked about were those that were likely to recur throughout an applicant’s lifetime.124 placing a temporal limit on the question makes it seem that the indiana board of law examiners has taken it upon itself to further limit its inquiries into applicants’ mental health histories; however, this is not necessarily so. although there is now a five-year limit within which an applicant must disclose whether he or she has been diagnosed or treated for a “serious condition,” current question 25 now includes language requiring an applicant to disclose any “other emotional disorder” or “any other psychotic disorder.”125 no definition is provided for what constitutes an emotional disorder or a psychotic disorder, so these categories have the potential to serve as a catchall, encompassing almost an endless number of conditions that an applicant would be required to disclose on his or her character and fitness application. the “emotional” or “psychotic” disorder language of question 25 is also similar to the language of a question posed by the virginia bar that was ultimately held to be a violation of title ii of the ada.126 in clark v. virginia board of bar examiners, an applicant seeking admission to the virginia bar challenged the application questions asked regarding her mental health as being in violation of the ada. 127 the applicant, julie ann clark, was a graduate of george mason university law school and “suffers from a condition that was previously diagnosed as ‘major depression, recurrent.’”128 124 aclu of ind. v. individual members of the ind. state bd. of law exam’rs, no. 1:09-cv-824-twp-mjd, 2011 wl 4387470, at *2 (s.d. ind. sept. 20, 2011). 125 ind. supreme court bd. of law exam’rs, supra note 16. 126 see clark v. va. bd. of bar exam’rs, 880 f. supp 430, 437-438 (e.d. va. 1995). 127 id. at 433. 128 id. at 432. 2016 501 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions on her bar application, ms. clark was asked to answer a question that stated, “[h]ave you within the past five (5) years, been treated or counseled for a mental, emotional, or nervous disorders?”129 she declined to answer this question, which if responded to in the affirmative would have required her to provide the “dates of treatment or counseling,” contact information for her health care provider, hospital, or institution, and a complete description of the diagnosis and treatment.130 although “pursuant to agreement of counsel,” the virginia board of bar examiners allowed ms. clark to sit for the virginia bar exam without answering the question and providing the requisite information, it would not grant her a license until she did so.131 ultimately, the court found that the question subjected applicants to discrimination based on their disability, as additional eligibility criteria was imposed on individuals with disabilities.132 thus, in order for the question at issue to comply with title ii of the ada, it would have to be necessary to the performance of the virginia board of bar examiners’ licensing function. however, the court did not find that the question was necessary.133 instead, it found that the question was not a strong indicator of identifying unfit applicants and that it had a strong deterrent effect on applicants.134 this same logic and reasoning can be applied to indiana’s question 25. the question places additional eligibility criteria on indiana bar exam applicants without being necessary to the indiana board of law examiners’ licensing function – the power it has to grant licenses to individuals to practice law within the state. the extremely broad scope of the listed conditions in which an individual is required to disclose a diagnosis or treatment is likely to have a deterrent effect on applicants from either seeking treatment or from being forthcoming on the application, which is completely adverse to the aim that the question is intended to serve. 129 id. at 433. 130 id. 131 id. 132 id. at 442. 133 id. at 446. 134 id. at 446. 502 indiana health law review vol. 13:2 these concerns are of the utmost importance, as “[a]pproximately 1 in 4 people have a mental health problem.”135 however, in the united states and europe, up to 75% of these people will not receive treatment, in part because of the stigma associated with receiving treatment for mental health related issues, which perpetuates individuals’ fear of having to disclose a mental health condition.136 although the scope of indiana’s question 25 is limited to five years, there remains no focus on an applicant’s behavior or specific conduct that he or she has exhibited within the past five years. instead, the question solely focuses on an applicant’s diagnosis and/or treatment. this type of inquiry is likely to result in false positives, as “there is simply no empirical evidence that applicants’ mental health histories are significantly predictive of future misconduct or malpractice as an attorney.”137 apart from question 25 being in violation of title ii of the ada because of the additional eligibility criteria that it places on applicants that respond affirmatively, and because it is not necessary to the indiana board of law examiners’ licensing function, it also raises valid public policy concerns. one of the main issues surrounding the states’ inquiries into applicants’ mental health histories is whether or not such inquiries will deter individuals who wish to seek treatment or speak with a counselor because individuals fear receiving a diagnosis they must disclose on the character and fitness application. additional concerns arise when applicants decide to get treatment, but are not fully forthcoming about their symptoms with their physicians out of fear that they will be required to disclose any diagnosis they receive. 138 because 135 stigma ‘key deterrent’ in accessing mental health care, kings c. london news (feb. 26, 2014), http://www.kcl.ac.uk/ioppn/news/ records/2014/february/stigma-key-deterrent-in-accessing-mentalhealth-care.aspx/[https://perma.cc/2lxk-w8mx]. 136 id. 137 bauer, supra note 13, at 141. 138 see, e.g., clark v. va. bd. of bar exam’rs, 880 f. supp 430, 44546 (e.d. va. 1995); hughes, supra note 23, at 189-190. see also chris iliades, are you telling your doctor the truth about your depression?, everyday health (jan. 2016 503 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions any successful patient-physician relationship rests on full disclosure from the patient, any treating physician with less than complete understanding of a patient’s condition will not be able to provide the best care for the patient.139 patients’ ability to feel comfortable with their physician often is synonymous with them being candid with their treating physicians. this candidness is especially imperative in instances of mental illness. providing an abridged version of symptoms and feelings may result in a misdiagnosis, which may result in the prescription of medication when medication is not needed, a wrong dosage of a medication, or a prescription for the wrong type of medication. one or a combination of these events could worsen an individual’s symptoms or not help at all, which could further inhibit his or her desire to seek help. 2. question 26 question 26a, which asks whether an applicant has a condition or impairment that in any way currently affects, or if untreated could affect, his or her ability to practice law is seemingly identical to former question 24, which the court in aclu of indiana allowed to stand because of its focus on the current time period and of an individual’s current ability to practice law.140 however, it does not appear that the entire question is truly focused on an individual’s current ability to practice law and therefore, it may be considered to run afoul of title ii of the ada. the first portion of the question is focused on whether an applicant has a condition or impairment that is currently affecting him or her in a way that would impede upon the applicant’s ability to practice law. because this focuses on an applicant’s current behavior as a result of his or her mental fitness, it is likely suitable under the ada. by inquiring into the conduct of the applicant, this question is not stereotyping based upon the applicant’s disability, which is what title ii 23, 2013), http://www.everydayhealth.com/health-report/ majordepression/telling-psychiatrist-the-truth.aspx [perma.cc/x4dy-8whk]. 139 clark, 880 f. supp. at 438-440. 140 aclu of ind. v. individual members of the ind. state bd. of law exam’rs, no. 1:09-cv-824-twp-mjd, 2011 wl 4387470, at *13 (s.d. ind. sept. 20, 2011). 504 indiana health law review vol. 13:2 of the ada seeks to prohibit. although – to an extent – question 26a does impose additional eligibility criteria on an applicant based upon his or her disability, for it to be considered a violation of title ii of the ada, it would have to be shown that the question was unnecessary to the indiana board of law examiners’ licensing function. this question has a more direct relation to the board’s goals of inquiring into an applicant’s mental health history – to screen out applicants that may pose a risk to themselves or others in the course of the practice of law. it requires applicants to disclose a condition only if it is currently affecting them in a way that may conflict with their ability to practice law in a competent manner, not solely because an applicant has been diagnosed with a certain disorder or is receiving treatment for a disorder. thus, the burden it places on applicants is not an undue burden, but it is rather seeking to inquire into specific conduct and behaviors that may pose an actual risk to the applicant’s ability to effectively engage in the practice of law. although there are certainly valid arguments as to why the first part of question 26a is necessary to the indiana board of law examiners’ licensing function, the question as a whole is overly broad, which may have negative implications. because of the question’s broad nature, it may deter applicants from applying to the bar, or deter those who do apply from responding truthfully to the question. additionally, applicants may not consider the type of behavior they are exhibiting to be the type of condition or impairment that needs to be disclosed. in sum, the first portion of question 26a makes a more conduct-focused inquiry, which is the type of question that the doj opines is compliant with title ii of the ada. as such, it is much more suitable to providing applicants’ the rights they are afforded under the ada. however, because of the broad nature of the question, it is possible that this question will not truly assist the indiana board of law examiners in screening out the applicants that may pose a threat. apart from the public policy concerns that the question may deter applicants from applying to the bar, or if they do apply, from providing full disclosure, question 26a seems to be a well-suited question both to protect the rights and privacy of applicants afforded to them under title ii of the 2016 505 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions ada. however, the ‘if untreated could affect’ language bears no connection to an applicant’s current mental fitness. rather, it is solely hypothetical in nature. by including this portion of the question, far more applicants will be required to respond affirmatively and will be required to complete a form b-1. form b-1 requires the applicant to list dates of treatment, the name and contact information of his or her provider(s), and a detailed description of the “type of problem, condition, impairment, diagnosis, treatment, and/or monitoring program.”141 additionally, if an applicant responds in the affirmative to question 26a, he or she must answer 26b, which asks whether the limitations or impairments resulting from the applicant’s mental health condition are reduced or improved because of treatment. if an applicant is undergoing treatment that improves the condition, and thus answers question 26b affirmatively, the applicant is required to fill out another form b-1 detailing information about that treatment and the contact information for his or her provider. overall, the second prong of question 26a weakens the arguments that asking applicants this question is necessary to the indiana board of law examiners’ licensing function. as a whole, question 26a places additional eligibility criteria upon applicants regarding their mental health status and requires them to opine on the types of behavior that they would exhibit if their conditions were left untreated. this forces applicants who are, and have always been, treated for their condition to determine whether they would behave in a way that was not competent or ethical in the practice of law if they were not being treated. further, the “if left untreated” language of question 26a requires a greater number of individuals to respond affirmatively to this question. as it is asked, individuals who have a condition or impairment that is under control and would not affect their ability to practice law in a competent manner would not be required to respond affirmatively. 141 ind. supreme court bd. of law exam’rs, character & fitness questionnaire form b-1, application information (2016), available at https://myble.courts.in.gov/browseapplication.action?id=9 (last visited apr. 20, 2016) (select “browse form” beside “character and fitness questionnaire,” click “general questions” in the dropdown bar, select “yes” under question 26a). 506 indiana health law review vol. 13:2 however, the second prong of the question may require such individuals to have to disclose their condition anyway if the untreated condition would affect their behavior. like the “other emotional” or “psychotic” disorder language in question 25, inquiring into the hypothetical behavior of an applicant is too broad of a reach, and does not effectively protect the rights and privacy of applicants. 3. question 27 indiana’s question 27, which seeks information regarding whether a mental health condition has been used as a defense, mitigating factor, or explanation for an applicant’s actions, once again fails to focus on the current conduct or behavior of an applicant. this question is extremely similar to the ncbe’s question 27 both prior to and after the changes it made to questions 25 and 26. the indiana bar exam application thoroughly investigates applicants’ experiences with civil and criminal litigation, employment history and educational history by asking specific, direct questions. therefore, there is ample opportunity to question applicants on such events, including any such defenses, which if answered affirmatively, will allow for the applicant to be further questioned or for additional information to be obtained. thus, it may be argued, as it was by the doj, that such question is unnecessary.142 because many of the types of behavior and conduct that this question asks about are thoroughly covered by other sections of the indiana bar exam, there is a chance that this may be considered placing additional criteria upon applicants based upon their disability. however, if whether a question focuses on an applicants’ current conduct and/or behavior is used as the sole yardstick to determine compliance with title ii of the ada, question 27, to the extent it reveals such current conduct or behavior, may be considered compliant. 142 letter from jocelyn samuels, supra note 93, at 23. 2016 507 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions b. summary the similarities between indiana’s current questions relating to mental health and the former ncbe questions, which the doj opined are in violation of title ii of the ada, should not be ignored. for these mental health related inquiries to comply with title ii of the ada, it must be shown that despite the additional eligibility criteria that the questions place on applicants based on their mental health status, the questions are necessary to the indiana board of law examiners’ licensing function. however, as it has been demonstrated, it is unlikely that indiana’s questions, as currently written, are truly necessary. thus, the questions should be re-evaluated to ensure that applicants are being afforded the full protections provided to them under title ii of the ada. while the simple solution may be to amend all mental health-related questions to conduct-based questions in order to comply with what the doj deems ada appropriate questions, it may not truly remedy all of the issues associated with inquiring into applicants’ mental health histories. thus, although bringing indiana’s questions into full compliance with title ii of the ada is surely a positive step to rectifying the issues posed by inquiring into applicants’ mental health histories, the only way to truly remedy the deterrent effect caused by such inquiry is to begin to work toward removing the stigma surrounding mental illness. iv. conclusion the high rates of depression and mental illness among both law students and practicing attorneys in the united states make states’ interest in ensuring applicants’ mental fitness one of high importance. by having a screening process in place to determine whether bar exam applicants are mentally fit to practice law, states are ensuring safety not only for the attorneys themselves, but also for the attorneys’ colleagues and clients. indiana made adjustments to the ways in which it questions applicants regarding their mental health histories following the aclu of indiana decision. however, the measures taken were not enough to bring indiana’s mental 508 indiana health law review vol. 13:2 health related questions in compliance with title ii of the ada. indiana’s current approach delves too deeply into the generalities of an applicant’s mental health history instead of inquiring into how any such conditions have impacted the behavior and conduct of the applicant. this places additional eligibility criteria on these applicants based upon the stereotypes and generalizations associated with their mental health condition that are not necessary to the board of law examiners’ licensing function – a violation of title ii of the ada. amending bar exam questions to be more behavior and conduct focused will bring indiana’s mental health related questions into compliance with title ii of the ada. inquiring into specific behaviors that may interfere with an applicant’s ability to practice law would still place additional criteria upon those applicants with mental conditions who, based upon their responses to the questions, would be required to disclose additional information. however, these additional criteria are placed upon the applicants because they have exhibited behaviors that may impact their effectiveness to practice law, not solely because they have been diagnosed with or are receiving treatment for a mental health condition. additionally, amending indiana’s mental health related questions to conduct-specific inquiries would likely lessen the number of false positives during an application cycle. this would reduce the extra attention required of the indiana board of law examiners during an application cycle, as it would no longer be expending time and resources to further inquire into perfectly fit applicants’ character and fitness eligibility. while designing questions that comply with title ii of the ada is important to protect applicants’ privacies and rights afforded to them by the law, there are far greater issues underlying how indiana questions its applicants’ mental health histories. ultimately, the stigma surrounding mental health related issues is the main cause for concern. until this stigma is removed, zealous advocates that are passionate about the law will be deterred from pursuing careers in law solely because of the fear of having to disclose their mental health status. current law school students who are experiencing concerning symptoms will be hesitant to get help for fear of being flagged during the bar application 2016 509 it isn’t crazy: why indiana should reevaluate its mental health related bar exam application questions process, of conditional admission, or of being referred to jlap. students that have been diagnosed with and are being treated for mental health related issues may be hesitant to be fully candid with their treating physicians or to be truthful in their disclosures on the bar exam application, which only hinders those individuals themselves from getting the best care. in both the law school and legal profession cultures, more discussion needs to be had regarding mental illness. the topic needs to be de-stigmatized and cease being considered taboo. it needs to be more than a pamphlet handed out at 1l orientation or a topic subtly mentioned at firm in-service meetings. until the stigma surrounding mental illness is removed, any set of questions inquiring into bar exam applicants’ mental health histories will not fully suffice, regardless of whether they are compliant with title ii of the ada. only by changing the way in which the legal profession views and discusses mental illness will it become possible to create the illusive set of questions that “[strikes] the perfect balance between detecting problematic bar applicants and respecting applicants’ privacy” that the court in aclu of indiana alluded to.143 143 aclu of ind., 2011 wl 4387470, at *13. causing conflict: indiana's mandatory reporting laws in the context of juvenile defense causing conflict: indiana's mandatory reporting laws in the context of juvenile defense megan m. smith* i. introduction. ............................... .... 440 ii. the history of child abuse and mandatory reporting laws. .......................... ....... 442 iii. the legal rules at issue ....................... 446 a. attorney-client privilege ............. ........ 446 b. duty of confidentiality .......................... 448 c. indiana's mandatory reporting laws . ........... 450 d. how indiana addressed the conflict between the duty of confidentiality/attorney-client privilege and its broad mandatory reporting la ws ....... ....... 451 iv. why attorneys should not be mandatory reporters ........................................ 453 a. mandatory reporting does not deliver its intended effect. ................................. .... 453 b. mandatory reporting undermines attorney-client privilege................................... 455 c. indiana legislature did not intend to abrogate the attorney-client privilege ................. ..... 457 d. mandatory reporting could violate the sixth amendment ................................... 459 1. constructive denial........................ 462 2. conflict of interest ......................... 466 v. how other states have addressed the attorney as a mandatory reporter ........... ............ 470 vi. what indiana could do to rectify the problem... 473 a. permissive reporting............ 473 b. exceptions to mandatory reporting... ......... 475 c. exclusion ofa ttorneys as mandated reporters........ 475 1. full exclusion ........................ ..... 475 2. limited exclusion ..................... ...... 477 j.d., 2013, indiana university robert h. mckinney school of law, indianapolis, indiana; b.s., 2004, indiana state university, terre haute, indiana. indiana health law review vii. conclusion ................................... 478 i. introduction child abuse has occurred since the dawn of time; however, it was not recognized as a social problem until the early 1960s.1 today, most people recognize the need to criminalize child abuse and protect children from this repugnant act. however, many still fail to recognize children's rights within the legal system.2 this polarization between protecting children and preserving children's rights could lead to a consequential clash within our legal system. the supreme court has established that children, like adults, have a constitutional right to counsel, which implicitly includes attorney-client privilege.3 the importance of a juvenile client's ability to speak honestly and frankly with his or her attorney cannot be overstated. juveniles have the same right as adults to fully participate in and direct their representation;4 they should not be stunted in their defenses by laws that were created to protect them. each state throughout the united states has enacted what have become known as mandatory reporting statutes. these laws can, and certainly do in some states, have a direct effect on the attorney-client privilege. these laws have the ability to diminish, undermine, or remove the attorney-client privilege in certain contexts, particularly in the context of juvenile defense. while commentators agree the attorney-client privilege has never been afforded constitutional protection,5 there could also be sixth 1 ellen marrus, please keep my secret: child abuse reporting statutes, confidentiality, and juvenile delinquency, 11 geo. j. legal ethics 509, 514 (1998). 2 marvin r. ventrell, rights & duties: an overview of the attorney-child client relationshp, 26 loy. u. chi. l.j. 259 (1995). 3 in re gault, 387 u.s. 1, 4 (1967). 4 see generally id. 5 camile glasscock dubose & cathy 0. morris, the attorney as mandatory reporter, 68 tex. b.j. 208, 211 (2005); see also upjohn co. 440 vol. 11:1 causing conflict amendment implications for abused or neglected juvenile clients if the fear of that abuse or neglect being reported prevents them from fully communicating to their attorney everything necessary for effective representation. without the benefit of the whole truth, the attorney may be unable to provide the client with a complete defense. one of the most disconcerting aspects of mandatory reporting statutes, in general, is that they may "force attorneys to breach their clients' trust and confidence . . . or to face criminal liability."6 the inherent conflict contained in mandatory reporting statutes is evident. on one hand, attorneys are prevented by the attorney-client privilege from revealing their client's confidences. on the other hand, however, public policy dictates that children must be kept safe from harm.7 the point at which attorneys are permitted or required to break a client's confidence by reporting child abuse or neglect will depend upon the language of the state statute where the attorney is located. indiana requires that any person must report suspicions or knowledge of abuse or neglect.8 the juvenile code in indiana contains specific statutes abrogating certain communicative privileges for the purpose of complying with the mandatory reporting laws.9 however, these statutes do not specifically abrogate the attorney-client privilege, causing a conflict between the privilege and the duty to report.'0 by not excluding attorneys as mandated reporters, indiana's mandatory reporting laws fail to take into account the negative ramifications of attorneys reporting the abuse of their clients, especially if the clients do not want the v. united states, 449 u.s. 383, 389 (1981) (quoting the federal rules of evidence that "the privilege of a witness . . . shall be governed by the principles of the common law.. ."). 6 katharyn i. christian, comment, putting legal doctrines to the test: the inclusion of attorneys as mandatory reporters of child abuse, 32 j. legal prof. 215, 216 (2008). 7 id. at 217. 8 ind. code § 31-33-5-1 (2013) (emphasis added). 9 frances g. hill & derelle watson-duvall, chins deskbook 2001, at 4-2 (2001 ed. 2001), available at www.kidsvoicein.org/programs/ clcilchins/deskbook/2001/ch_4.shtml, see also § 31-32-11-1. 10 hill & watson-duvall, supra note 9, at 4-2 to 4-3. 2014 441 indiana health law review abuse reported. the inclusion of attorneys as mandated reporters undermines the attorney-client privilege between a juvenile client and his or her defense attorney while possibly violating his or her sixth amendment right to counsel. this note discusses how the conflict created by indiana's mandatory reporting laws undermines the attorney-client privilege and possibly violates the sixth amendment right to counsel when the physical and sexual abuse or neglect of a juvenile is discovered by attorneys representing the victims. part ii of this note looks at the history of child abuse and the subsequent development of mandatory reporting laws in the united states. part iii examines the laws and legal rules entwined with indiana's mandatory reporting laws, and how indiana addressed the conflict between them. part iv of this note discusses why attorneys, particularly those engaged in juvenile defense, should not be mandated reporters, while part v explores how, and whether, other states have addressed this issue. finally, part vi argues that in order to alleviate these problems for juveniles and their defense attorneys, indiana should amend its mandatory reporting laws to provide for permissive reporting for all attorneys or include an exception for defense attorneys. ii. the history of child abuse and mandatory reporting laws the first recorded case of child abuse occurred in new york city in 1874 when mary ellen wilson was removed from her adoptive mother due to extensive physical abuse.11 at the time of her removal from the home, mary ellen had bruises and scars covering her body and gashes over one eye and on her cheek. 12 although neighbors knew mary ellen was severely mistreated, even the authorities were reluctant to act until elbridge t. gerry, the attorney for the 11 thomas l. hafemeister, castles made of sand? rediscovering child abuse and society's response, 36 ohio n.u. l. rev. 819, 832 (2010). 12 id. at 833. 442 vol. 11:1 causing conflict american society for the prevention of cruelty to animals, intervened as a private citizen on behalf of mary ellen after receiving word of her story. 13 the publicity that stemmed from this case prompted the institution of charitable organizations aimed at preventing child abuse, including mr. gerry, who established the new york society for the prevention of cruelty to children.14 even after the case of mary ellen wilson, child abuse was still not a matter of much concern until dr. c. henry kempe published an article in the journal of the american medical association in 1962.15 his article, the battered child syndrome, became the catalyst for identifying and researching the effects of child abuse; within three years of its publication, over 300 scientific articles were published on child abuse.16 until publication of the battered child syndrome, child abuse had largely been relegated to "disadvantaged families," and considered rare even in those circumstances.1 7 this article brought child abuse and the need to address its devastating effects to the forefront of the medical and legal communities. however, as the title suggests, dr. kempe's article focused mainly on the physical abuse of children. child abuse now encompasses a varying array of behaviors or omissions.18 in order to combat child abuse, states began enacting what have become known as "mandatory reporting laws." after the publication of the battered child syndrome, reporting statutes began emerging in states throughout the country; by 1967, every state had at least some variation of a reporting statute.19 because of dr. kempe's article, these statutes were originally aimed at medical professionals and 13 id. at 832-33. 14 id. at 833. 15 marrus, supra note 1, at 514; see also c. henry kempe et al., the battered-child syndrome, 9 child abuse and neglect 143 (1985) (reprinted with permission of the american medical association and first published in the journal of american medical association). 16 hafemeister, supra note 11, at 838. 17 id. at 837-38. 18 see ind. code § 31-9-2-133 (2013). 19 marrus, supra note 1, at 514. 2014 443 indiana health law review serious physical or non-accidental injuries. 20 as the statutes developed, they began to follow one of two formats: (1) various professionals were listed as mandatory reporters, or (2) a catch-all provision required "any person," "all persons," or "any other person," to report child abuse.21 overtime, however, these statutes have transformed into broad, wide-ranging statutes. some statutes, like indiana's statute, still require "anyone" or "all persons" to report. other states only require a report to be made if there are suspicions of possible abuse. the federal government became involved in 1974 when congress passed the child abuse prevention and treatment act (the "act"), which requires each state to enact some type of mandatory child abuse reporting statute in order to be eligible for federal funding. 22 the act, however, did little to encourage uniformity of reporting statutes amongst the states. as such, child abuse reporting statutes vary widely from state to state, especially in regard to the professionals who adhere to confidentiality privileges; some states impose mandatory reporting requirements while others allow for permissive reporting.23 mandatory reporting laws regularly conflict with other professional obligations, such as the attorney-client privilege and the duty of confidentiality for doctors, clergy, and lawyers. most states have created an exception to the rule of doctorpatient confidentiality, while the duties of confidentiality for clergy and lawyers are still widely debated. the protection of children is the primary purpose of mandatory reporting laws. 24 most of the time, the abuser is 20 see alison beyea, competing liabilities: responding to evidence of child abuse that surfaces during the attorney-client relationship, 51 me. l. rev. 269, 272 (1999). 21 christian, supra note 6, at 218-19. 22 child abuse prevention and treatment act, 42 u.s.c. §§ 51015107 (2013); see also ventrell, supra note 2, at 267; brooke albrandt, turning in the client: mandatory child abuse reporting requirements and the criminal defense of battered women, 81 tex l. rev. 655, 656 (2002). 23 dubose & morris, supra note 5, at 210. 24 beyea, supra note 20, at 288. vol. 11-1444 causing conflict the child's parent or primary caregiver, 25 resulting in the victim being dependent on the abuser for support and care. 26 if the victim is dependent on the abuser, it is unlikely he or she would be willing to leave or report the abuse of his or her own accord. these mandatory reporting statutes were intended to resolve this struggle. unfortunately, many of these statutes have simply replaced one conflict with another. the indiana legislature expressed that the purposes of its mandatory reporting statute are to (1) encourage effective reporting of suspected or known incidents of child abuse or neglect; (2) provide effective child services to quickly investigate reports of child abuse or neglect; (3) provide protection for an abused or a neglected child from further abuse or neglect; (4) provide rehabilitative services for an abused or a neglected child and the child's parent, guardian, or custodian; and (5) establish a centralized statewide child abuse registry and an automated child protection system. 27 the indiana court of appeals clarified that the purpose of the state's mandatory reporting laws was to identify children in need of immediate attention, not to provide a mechanism for prosecuting offenders. 28 the seventh circuit explained that the rationale behind enacting statutes that require individuals to report suspected or known child abuse stems from the characteristics special to abused children. 29 25 see hafemeister, supra note 11, at 824-28. 26 beyea, supra note 20, at 275. 27 ind. code § 31-33-1-1 (2013); see also anonymous hosp. v. a.k., 920 n.e.2d 704, 709 (ind. ct. app. 2010). 28 daymude v. state, 540 n.e.2d 1263, 1266 (ind. ct. app. 1989). 29 aylward v. bamberg, no. 98-2119, 1999 wl 515203, at *2 (7th cir. july 6, 1999). the seventh circuit listed the characteristics special to abused children as the inability to recognize their own abuse or 2014 445 indiana health law review mandatory reporting laws, understandably, arose in order to combat the prevalence of child abuse, a notable and necessary objective that could hardly be discouraged. however, regardless of the rationale or purpose stated to support a state's mandatory reporting statute, the substance of this type of law has a widespread effect on other areas of the law. which areas of the law and how much they are affected will depend upon the specific language of each state's mandatory reporting statutes. iii. the legal rules at issue indiana's mandatory reporting laws have implications far outside the statute itself. mandatory reporting by attorneys in indiana creates an interaction of three types of legal rules: the attorney-client privilege, the rules of professional conduct, and the state reporting statutes. in order to determine whether attorneys in indiana are required to report child abuse under the mandatory reporting laws, one must read all three types of legal rules together. a. attorney-client privilege the attorney-client privilege protects against judicially compelled disclosure of confidential communications made by a client to an attorney in order to procure legal advice or legal services.30 it is generally recognized as the oldest existing common law privilege.3 ' the importance of this privilege is evinced by its codification into state statutes, rules of professional conduct, and rules of evidence. 32 the attorney-client privilege has one major exception, which is commonly known as "the crime-fraud exception." injury, the inability to report abuse due to age or fear of retaliation, the difficulty of third parties to detect the effects of abuse, the likelihood of physical and emotional scarring, and the limited ability of children to choose their own course of action. 30 colman v. heidenrich, 381 n.e.2d 866, 868-69 (ind. 1978). 31 see upjohn co. v. united states, 449 u.s. 383, 389 (1981); marrus, supra note 1, at 521. 32 marrus, supra note 1, at 522. 446 vol. 11:1 causing conflict essentially, the attorney-client privilege is void if the communication between lawyer and client is in furtherance of ongoing or future criminal or fraudulent conduct.3 3 this exception is aimed at public fairness; by ensuring that only communications made for the purposes of abiding by the law and receiving effective representation, it prevents criminals from hiding behind the veil of attorney-client privilege.34 this exception is not applicable where attorneys have garnered suspicions of abuse through the defense representation of juvenile clients. while it is possible that the abuse is ongoing and would meet the ongoing crime element, the juvenile is the victim, not the perpetrator of the crime; therefore, the attorney-client privilege should remain intact. one possible exception to this exception would be an attorney learning that the juvenile client was abusing another child and the attorney's communications were intended to further the abuse.35 in this instance the crime-fraud exception would attach and the attorney-client privilege would no longer exist. however, any communications that took place after the abuse, and not in furtherance of, would remain privileged. the attorney-client privilege was designed to "encourage full and frank communication between attorneys and their clients."36 the supreme court stressed the need for the lawyer, as advocate and counselor, to know all information that relates to the client's representation in order to provide the appropriate, professional representation. 37 the court furthered that "the privilege exists to protect not only the giving of professional advice . . . but also the giving of 33 developments in the law privileged communications: attorney-client privilege, 98 harv. l. rev. 1501, 1510 (1985). 34 id. 35 while unlikely, it is possible that a consultation with a juvenile client could consist of strategies or tips on how to continue the abuse while avoiding detection. in this situation, the crime-fraud exception would apply, and the communication between the attorney and client would not be privileged. 36 upjohn, 449 u.s. at 389. 37 id. at 390. 2014 447 indiana health law review information to the lawyer to enable him to give sound and informed advice. the first step in the resolution of any legal problem is ascertaining the factual background . . ."38 the public is also served when an attorney is able to provide thorough legal advice and counsel, but this is dependent upon the attorney being fully informed by the client.39 indiana has established the attorney-client privilege throughout its rules and statutes. one source of the attorney-client privilege in indiana is found in indiana code section 34-46-3-1 which provides in part that "except as otherwise provided by statute, the following persons shall not be required to testify regarding the following communications: (1) attorneys, as to confidential communications made to them in the course of their professional business, and as to advice given in such cases."4 0 another source for the attorney-client privilege is found in the indiana rules of evidence, providing that information subject to the attorney-client privilege retains its privileged character until the holder of the privilege (client) has waived said privilege by consenting to disclosure. 41 b. duty of confidentiality the duty of confidentiality provides an outline for attorneys' ethical obligations regarding their clients' confidences. 42 while often used interchangeably with attorney-client privilege, the duty of confidentiality encompasses a broader category of communications and information, including information that would not be covered under the attorney-client privilege. 43 the major difference between the duty of confidentiality and the attorney-client privilege is that any information learned 38 id. at 390-91. 39 id. at 389. 40 ind. code § 34-46-3-1 (2013). 41 see ind. evid. r. 501, 502. 42 see ind. prof. cond. r. 1.6. 43 adrienne jennings lockie, salt in the wounds: why attorneys should not be mandated reporters of child abuse, 36 n.m. l. rev. 125, 133 (2006). 448 vol. 11:1 causing conflict through the course of representation, regardless of the source, which includes information discovered from third persons or information learned during conversations occurring in front of a third party is protected;44 whereas the attorney-client privilege applies only to information received from the client. comment 3 to rule 1.6 explains that the rule of client confidentiality applies outside the context of evidence seeking and that it is applicable to all information relating to representation and not just information received from the client. 45 every state has developed its own set of ethical guidelines to provide attorneys with guidance in their practice of the law. these rules are largely modeled after the american bar association's (the "aba") model code of professional responsibility ("model code") or model rules of professional conduct ("model rules").46 in 1987, indiana enacted its rules of professional conduct which included rule 1.6 confidentiality of information ("rule 1.6").47 as of 2005, rule 1.6 prohibited a lawyer from revealing information relating to representation of a client unless the client gave informed consent, the disclosure was impliedly authorized in order to carry out the representation, or the disclosure was within one of the exceptions to rule 1.6.48 only two of the six exceptions listed under rule 1.6 are likely to become applicable regarding mandatory reporting statutes. a lawyer may reveal information to prevent reasonably certain death or substantial bodily harm or to comply with other laws or court orders. 49 c. indiana's mandatory reporting laws under indiana's mandatory reporting laws, any individual that has reason to believe that a child is a victim 44 see id.; beyea, supra note 20, at 280. 45 see ind. prof. cond. r. 1.6 cmt. 3. 46 see model code of prof'l responsibility canon 2 (1980); model rules of prof'l conduct (1983). 47 see ind. prof. cond. r. 1.6. 48 id. at 1.6(a). 9 id. at 1.6(b). 2014 449 indiana health law review of child abuse or neglect shall make a report.50 the duty to report is absolute and applies to all persons.5 ' for the purposes of this statute, "reason to believe" is defined as evidence that, if presented to individuals of similar background and training, would cause the individuals to believe that a child was abused or neglected. 52 the failure to make a report when required constitutes a class b misdemeanor and may result in criminal sanctions. 53 under this statute, any person who makes a report, in good faith, is immune from criminal and civil liability. 54 however, immunity will not attach and liability will be imposed if the report was made with malice or bad faith.55 in order to encourage reporting, the legislature imputed a presumption of good faith in all reporters. 56 indiana's mandatory reporting laws do not exclude lawyers from the reporting mandate.57 in 1998, indiana amended its mandatory reporting laws to remove the chapter abrogating evidentiary privileges; however, it retained a provision elsewhere in the juvenile code that prohibits certain privileged communications from being excluded as evidence in "any judicial proceeding resulting from a report of a child who may be a victim of child abuse or neglect . . . or failing to report as required by i.c. 3133."58 since "there is no statutory provision abrogating the attorney-client privilege for the purpose of reporting child abuse or neglect," such a report may constitute a violation of the attorney-client privilege.59 50 ind. code § 31-33-5-1 (2013) (emphasis added). 51 aylward v. bamberg, no. 98-2119, 1999 wl 515203, at *3 (7th cir. july 6, 1999). 52 § 31-9-2-101. 53 id. § 31-33-22-1. 5 id. § 31-33-6-1. 55 id. § 31-33-6-1, 2. 56 id. § 31-33-6-3; see kinder v. doe, 540 n.e.2d 111, 115 (ind. ct. app. 1989). 57 hill & watson-duvall, supra note 9, at 4-5. 58 donald r. lundberg, mandatory child abuse reporting by lawyers, res gestae, dec. 2011, at 31, 32 (quoting ind. code § 31-3211-1 (2011)). 59 hill & watson-duvall, supra note 9, at 4-5. 450 vol. 11:1 causing conflict d. how indiana addressed the conflict between the duty of confidentiality/attorney-client privilege and its broad mandatory reporting la ws there is little indiana case law on this issue to help attorneys resolve possible conflicts and problems that arise in the course of representation.6 0 the indiana court of appeals made clear in daymude, that attorneys who represent clients in cases involving child abuse will not be required to report any further information received from their clients about the alleged abuse. 61 the court stated that where the purpose of the reporting statue (to protect children from abuse) had already been met, there was no longer any justification for abrogating privilege.62 while mandatory reporting laws inherently conflict with the principles underlying the duty of confidentiality, the resolution to this conflict could be drawn from the notion that the ethical rules do not supersede statutes.63 indiana also established an abrogation statute and an exception to the duty of confidentiality. indiana has provided exceptions to rule 1.6 that allow an attorney to reveal confidential information under certain circumstances. the relevant exceptions allow an attorney to reveal confidential information to the extent the attorney reasonably believes it is necessary (1) to prevent reasonably certain death or substantial bodily harm or (2) to comply with other law or a court order.64 comment 12 refused to state equivocally when the other law would supersede rule 1.6.65 based on a plain language reading of theses exceptions, it appears that an attorney would be excepted from keeping confidential information pertaining to the abuse of a child 60 lundberg, supra note 58, at 34. 61 daymude v. state, 540 n.e.2d 1263 (ind. ct. app. 1989). 62 id. at 1266 (abrogating privilege in the physician-patient context). 63 lockie, supra note 43, at 133; see also ind. prof. cond. r. 1.6 cmt. 2. 64 ind. prof. cond. r. 1.6(b). 65 see id. at 1.6 cmt. 12. 2014 451 indiana health law review because child abuse is a crime that could result in death or substantial bodily harm, and the mandatory reporting laws requiring any individual to report meet the exception for complying with another law. because the communications provided for in the duty of confidentiality encompass the communications of the attorney-client privilege, one could argue that, by excepting the duty of confidentiality, indiana automatically carved out an exception to the attorney-client privilege. indiana has also codified immunity from civil or criminal liability that might occur as a result of reporting child abuse or neglect. 66 the seventh circuit concluded that when the immunity statute is combined with the mandatory reporting laws, any person, even if he or she is subject to privileged communications, is required to make a report of reasonably suspected child abuse.67 several different rationales have been put forth for the inclusion of attorneys as mandated reporters. specifically, because other professionals who have a recognized privilege similar to the attorney-client privilege are mandatory reporters, attorneys should also be included. 68 another rationale is that attorneys are officers of the court who owe a duty to society to protect it from imminent serious harm or death,69 and if they are not included as mandated reporters of child abuse then this duty is somehow violated. most of the discussion surrounding the concept of lawyers as mandated reporters revolves around the idea that the abuse will be discovered while the attorney is representing the child's parent or abuser. 70 this rationale is supported by the argument that attorney-client privilege does not apply in cases of ongoing or future crimes, which include 66 see ind. code § 31-33-6-1 (2013); aylward v. bamberg, no. 982119, 1999 wl 515203, at *3 (7th cir. july 6, 1999). 67 aylward, 1999 wl 515203, at *3. 68 marrus, supra note 1, at 538. 69 albrandt, supra note 22, at 660. 70 see generally dubose & morris, supra note 5; beyea, supra note 20; albrandt, supra note 22; lockie, supra note 43; lundberg, supra note 58; robert p. mosteller, child abuse reporting laws and attorenyclient confidences: the reality and the specter of lawyer as informant, 42 duke l.j. 203 (1992). vol. 11:1452 causing conflict child abuse because it is rarely limited to isolated incidents.7 1 iv. why attorneys should not be mandated reporters a. mandatory reporting does not deliver its in tended effect the hard-line mandatory reporting laws in indiana provide little flexibility to attorneys representing juvenile clients. while these laws seem to have little downside, they can result in negative ramifications for the children in which they were designed to protect. a study conducted by the united states department of health and human services found that in 2009 over sixty-four percent of all alleged cases of child abuse were unsubstantiated. 72 it may be inferred from these results that mandatory reporting statutes do not provide a significant tool in the fight to combat child abuse. such a large number of unsubstantiated reports indicates that mandatory reporting laws, in general, are written too broadly. this broad scope results in people reporting instances of non-abuse as abuse out of the fear of liability because the open language of the statute technically required a report. states are then wasting time and resources investigating tenuous reports instead of focusing that attention on the children and families who need it. forcing a juvenile defense attorney who suspects possible abuse or neglect to choose between complying with the mandatory reporting laws and their client's instruction is particularly problematic when the suspicions are minimal and such a high volume of unfounded abuse reports already exists. the ensuing investigation and possible removal of the juvenile from the family home could have negative consequences not considered by the indiana legislature 71 albrandt, supra note 22, at 660. 72 children's bureau, u.s. dep't of health & human servs., child maltreatment 2009, 7-8 (2010), available at http://archive.acf.hhs.gov/programs/cb/pubs/cm9/cmo9.pdf. 2014 453 indiana health law review when enacting mandatory reporting laws with such expansive language, especially if the allegations are determined to be unsubstantiated. a 2005 study on child maltreatment and juvenile delinquency found that abused children who are removed from the familial home are twice as likely to be subject to future delinquency petitions as children who remain in the family home.73 the results of this study also suggested that while placement increased the risk of delinquency in both male and females, repeated placements further increase the risk for males. 74 the authors opine that removal from the family home and placement into substitute care weakens the social attachments and social controls of these children, which increases the risk of delinquency.75 because removal is not always in the child's best interests, the juvenile client-victim, and his or her family, would likely benefit more from the attorney negotiating for alternative services in sentencing. alternative services vary depending on the juvenile's need, but can include counseling, continued education, community service, shortterm residential placement, substance abuse treatment, job training and placement, and mentoring programs.76 even though the majority of the reported cases are not substantiated, as the number of reported cases of child abuse continues to increase, fewer children are receiving subsequent services.77 if an attorney reports possible child abuse discovered during the course of representing a 73 joseph p. ryan & mark f. testa, child maltreatment and juvenile delinquency: investigating the role of placement and placement instability, 27 child. and youth servs. rev. 227, 241 (2005). 74 id. at 243. 75 id. at 244. 76 see generally jerome r. price, birthing out delinquents: alternative treatment options for juvenile delinquents, 4 crim. l. brief 51 (2009) (arguing for an increased use of alternative treatments to lower the frequency of juvenile delinquency); stephen a. campbell, alternatives in the treatment of juvenile offenders: current options and thends, 19 j. juv. l. 318 (1998) (analyzing the alternative options for treating juvenile offenders). 77 see children's bureau, supra note 72, at 84-85; hafemeister, supra note 11, at 824. vol. 11:1454 causing conflict juvenile client, there is no guarantee that the juvenile will receive services. therefore, by negotiating for alternative sentencing options, an attorney may be in a better position to help the juvenile than social services. when situations such as this arise, one can hardly argue that indiana's mandatory reporting laws afford the protection they were designed to provide. additionally, the acknowledgment of a juvenile's individual autonomy can foster self-confidence and cultivate a sense of responsibility.7 8 it is incongruous that a juvenile defendant is considered to have the capacity to stand trial and be adjudicated a delinquent or criminal while at the same time being told by mandatory reporting laws that he or she does not have the capacity to determine if his or her attorney may reveal private, confidential information. the goal of mandatory reporting laws is to protect and foster children, yet those laws too often function in a contrary manner. b. mandatory reporting undermines attorney-client privilege attorney mandated reporting "would deny any discretion not to report abuse, would significantly and detrimentally alter the attorney-client relationship. it might also have the effect of thwarting the very goal of such legislation; namely the protection of children."79 victims of child abuse are more likely to engage in delinquent behaviors than the general population, therefore, it is highly likely that a juvenile defendant in delinquency proceedings will be the victim of some form of abuse.80 the attorney-client privilege is "an essential component of our advocacy system and plays just as important a role in juvenile legal proceedings."81 78 rhonda gay hartman, adolescent autonomy: clarifying an ageless conundrum, 51 hastings l.j. 1265, 1268 (2000). 79 beyea, supra note 20, at 275. 80 see ryan & testa, supra note 73. 81 marrus, supra note 1, at 520. 4552014 indiana health law review one of the most notable hallmarks of the attorney-client relationship is the fundamental principle that without the client's authorization, the attorney will keep his confidences. 82 it is this trust that allows clients to communicate fully and frankly with their attorney, providing the attorney with the information necessary to provide effective legal representation and advice. 83 a lawyer's need for the truth does not always revolve around the defense; the truth is necessary for the negotiation of settlements and services that are often involved in juvenile cases. as discussed above, many times a juvenile suffering from abuse could benefit substantially more from services negotiated for by defense counsel than from the subsequent actions of the state after a child abuse report. unfortunately, indiana's mandatory reporting laws fail to address this important situation. mandated reporting by attorneys could have a "chilling effect" on the interaction and communication between a juvenile client and his or her attorney.84 if attorneys notify their juvenile clients of an attorney's duty under the exceptions to the duty of confidentiality, one of two scenarios is likely to occur.85 the juvenile client does not comprehend the exception; the attorney reports abuse; and the client feels betrayed. 86 in the second scenario, the juvenile client understands the exception; the client does not trust the attorney; and consequentially withholds information from the attorney.8 7 neither scenario provides the juvenile client with the quality of representation to which they are entitled. because the development of trust between an attorney and client is so important to the attorney-client relationship, if a juvenile does not trust his or her attorney then he will be less likely to confide in the attorney. the lack of trust affects the quality of the representation, the 82 see ind. prof. cond. r. 1.6 cmt. 2. 83 see id. 84 marrus, supra note 1, at 527. 85 i~d. 86 id. 87 id. 456 vol. 11:1 causing conflict juvenile's dissatisfaction with the results, and his or her ultimate view of the legal system. once a juvenile has developed a negative impression of the legal system, he or she is less likely to respect and abide by the laws implemented by that system. if the attorney is uncomfortable with the juvenile's refusal to consent to disclosure, the attorney could withdraw from the case. however, this has the potential of leading to a revolving door of attorneys. eventually, the juvenile would learn that if he or she wants to keep an attorney then he or she should not discuss the abuse, which will ultimately prevent the full and frank disclosure intended by the attorney-client privilege. c. indiana legislature did not intend to abrogate the attorney-client privilege the legislature has the power to abrogate or modify common law rights.88 indiana statutes permit the inclusion of privileged communications as evidence in judicial proceedings when those proceedings are a result of a report of child abuse or a failure to report child abuse.89 this provision, however, does not list the attorney-client privilege among the privileges that have been abrogated; therefore, it appears the legislature intended to preserve the attorney-client privilege over the duty to report child abuse.90 this statute reveals the intent of the legislature to specifically include professionals who will be most likely to have significant contact with children.91 while some attorneys may have significant contact with children, particularly those engaged in family law, the majority of attorneys will not. this is especially true when compared with the professions whose privilege has been expressly 88 kinder v. doe, 540 n.e.2d 111, 114 (ind. ct. app. 1989). 89 ind. code § 31-32-11-1 (2013). 90 lundberg, supra note 58, at 32 (citing ind. code § 31-32-11-1 (2013)). 91 § 31-32-11-1 (including healthcare providers and mental health professionals). 2014 457 indiana health law review abrogated, which are most notably the medical and mental health professionals. "[pirivilege[s] [are] unavailable in circumstances under which the privileged communication is abrogated under indiana law."92 in jb. v. e.b., the indiana court of appeals specified that the statute abrogated the enumerated privileges. 93 the court further expounded that the abrogation statute was "designed to reconcile the operation of various privileges with indiana's reporting statute."94 attorney-client privilege is not listed among those privileges abrogated by the statute. if the legislature has the power to abrogate the attorney-client privilege and it took the time to enumerate nine other privileges, then it would have included the attorney-client privilege if it had intended for attorneys to be mandated reporters. additionally, the legislature knew the purpose of the abrogation statute was to resolve the conflict created by indiana's mandatory reporting laws and other communicative privileges, nevertheless it still chose to exclude the attorney-client privilege from those privileges abrogated under the statute. d. mandatory reporting could violate the sixth amendment the inability of an attorney to provide effective legal representation to a juvenile client due to the mandatory reporting laws could possibly violate the sixth amendment. in certain situations, mandatory reporting laws constrain the ability of attorneys to provide juvenile clients with complete and effective assistance; specifically, when the juvenile cannot supply the attorney with adequate information without the fear of reporting. a statute limiting the scope or effectiveness of representation can violate the sixth amendment. indiana's mandatory reporting laws can create a constructive denial of the right 92 j.b. v. e.b., 935 n.e.2d 296, 300 (ind. ct. app. 2010). 93 id. 94 d. 458 vol. 11:1 causing conflict to effective assistance of counsel and an irreparable conflict of interest. the sixth amendment provides that the accused in all criminal prosecutions "shall enjoy the right ... to have the assistance of counsel for his defense."95 the supreme court affirmed this provision of the sixth amendment was incorporated to apply to the states by the fourteenth amendment.9 6 the supreme court has also extended certain constitutional guarantees, including the right to assistance of counsel, to juveniles in delinquency proceedings, reasoning that juveniles need the assistance of counsel to "cope with problems of law, to make skilled inquiry into the facts, to insist upon regularity of the proceedings, and to ascertain whether he has a defense and to prepare and submit it.""9 the gault court was clear that juveniles were entitled to the protections under the bill of rights and the fourteenth amendment.9 8 although the sixth amendment does not say anything about effective counsel, it is implicit in the right to counsel that such counsel must provide effective assistance; otherwise the guarantee would be moot. the skill and knowledge of defense counsel create a critical role necessary to ensure the adversarial system produces just and fair results. 99 "for that reason, the court has recognized that the right to counsel is the right to the effective assistance of counsel."100 while an adult's right to effective assistance of counsel is based on the sixth amendment, a juvenile's constitutional right to the same is rooted in the due process clause of the fourteenth amendment. 101 generally this distinction would narrow the scope of the right to effective 95 u.s. const. amend. vi. 96 gideon v. wainwright, 372 u.s. 335 (1963). 97 in re gault, 387 u.s. 1, 36 (1967). 98 id. at 13. 9 strickland v. washington, 466 u.s. 668, 685 (1984). 100 id. at 686 (quoting mcmann v. richardson, 397 u.s. 759, 771 (1970)). 101 in re gault, 387 u.s. at 4. 2014 459 indiana health law review counsel in the juvenile context; however, this distinction has become "a distinction without a difference."10 2 indiana has expressly codified a juvenile's right to counsel when charged with a delinquent act.103 courts have supported a juvenile's right to counsel on both a statutory and case law basis. in nm v. indiana, the indiana court of appeals recognized the juvenile defendant's right to counsel under the sixth amendment, the state statute, and prior court decisions.104 indiana has demonstrated a heightened importance for the right to counsel in juvenile delinquency proceedings by including additional requirements necessary for a juvenile to waive the right to counsel. 05 the indiana court of appeals has acknowledged the magnitude of the right to counsel by both expressly and impliedly recognizing a juvenile's right to effective assistance of counsel in delinquency proceedings. 0 6 the supreme court has consistently discussed the significant value of the right to counsel guarantee in both the adult and juvenile contexts. "of all the rights that an accused person has, the right to be represented by counsel is by far the most persuasive for it affects his ability to assert any other right he may have." 07 the report by the president's commission on law enforcement and administration of justice, quoted at length by the court in gault, specifically emphasized the importance of a juvenile's right to counsel stating that "no single action holds more potential for achieving procedural justice for the child in the juvenile court than the provision of counsel" because independent counsel "is the keystone of the whole structure 102 gilliam v. state, 808 s.w.2d 738, 739 (ark. 1991) (quoting in re smith, 573 a.2d 1077, 1079 (pa. 1990)). 103 ind. code § 31-32-4-1(2013). 104 n.m. v. state, 791 n.e.2d 802, 805 (ind. ct. app. 2003). 105 see r.w. v. state, 901 n.e.2d 539, 544-45 (ind. ct. app. 2009) (requiring the additional showing of an actual consultation with parent or guardian before a juvenile's right to counsel can be waived). 106 see perkins v. state, 718 n.e.2d 790 (ind. ct. app. 1999); s.e. v. state, 744 n.e.2d 536 (ind. ct. app. 2001). 107 united states v. cronic, 466 u.s. 648, 654 (1984) (emphasis added) (quoting walter v. shaefer, federalism and state criminal procedure, 70 harv. l. rev. 1, 8 (1956)). 460 vol. 11.1 causing conflict of guarantees that a minimum system of procedural justice requires." 0 8 the vulnerability of juveniles combined with their lack of knowledge of the justice system further enhances the importance and need of the right to counsel for juvenile defendants, especially when the right to counsel invokes other state and constitutional rights. in strickland v. washington, the supreme court established the two-pronged test to be used in analyzing a defendant's effective assistance of counsel claim.109 the court said a defendant must show that counsel's performance was deficient and that the deficiency prejudiced the defense. 10 in order to prove counsel's performance was deficient, the defendant must show that counsel's representation fell below an objective standard of reasonableness, which will be determined by the prevailing professional norms of the legal profession.11' the supreme court, however, has affirmed that prejudice is presumed in certain contexts, and it need not be shown. prejudice is presumed when there is an actual or constructive denial of the assistance of counsel,112 and when an actual conflict of interest adversely affects counsel's performance.113 due to the "near identity of interests" of defendants in criminal proceedings and juveniles in delinquency proceedings, the same standards used to determine the ineffectiveness for adults should be used for juveniles.114 108 in re gault, 387 u.s. 1, 38 (1967); see also in re smith, 573 a.2d 1077, 1078 (pa. super. ct. 1990). the report enumerated certain rights that will only have a substantial meaning if the juvenile is also provided with competent counsel who can invoke those rights effectively; specifically these rights include: the right to confront one's accusers, to cross-examine witnesses, to present evidence and testimony of one's own, to be unaffected by prejudicial and unreliable evidence, to participate meaningfully in the dispositional decision, and to make an appeal. 109 strickland v. washington, 466 u.s. 668 (1984). 110 id. at 687. 111 id. at 687-88. 112 id. at 692. 113 see woods v. state, 701 n.e.2d 1208, 1223 (ind. ct. app. 1998). 114 in re smith, 573 a.2d 1077, 1081 (pa. super. ct. 1990). 2014 461 indiana health law review 1. constructive denial sixth amendment claims may be based on actual or constructive denial of the assistance of counsel altogether, as well as claims based on state interference with the ability of counsel to render effective assistance to the accused.115 "any such set of rules would interfere with the constitutionally protected independence of counsel and restrict the wide latitude counsel must have in making tactical decision."116 indiana's mandatory reporting laws close off many of the options available for negotiation and settlement of a case, thereby reducing the amount of tactical decisions, and sometimes even removing the decision altogether, that an attorney may have otherwise made in the situation. the "[glovernment violates the right to effective assistance of counsel when it interferes . . . with the ability of counsel to make independent decisions about how to conduct the defense."1 7 juveniles "require the guiding hand of counsel at every step in the proceedings against [them]."118 indiana's mandatory reporting laws inhibit and limit the guidance and effect counsel is able to provide by removing the attorneys' ability to make an independent assessment of their clients' needs and to determine the most beneficial defense therefrom. this ability is removed because indiana's mandatory reporting laws give attorneys only one option when suspicions or knowledge of abuse arise; they must report. attorneys are not given the option of evaluating the circumstances surrounding the situation and proceeding therefrom, nor are the attorneys given the option of determining what is in the best interest of clients or following their clients' wish that the abuse not be reported. 115 see strickland, 466 u.s. at 684; see also united states v. cronic, 466 u.s. 648, 656 (1984). 116 strickland, 466 u.s. at 689. 117 id. at 686. 118 in re gault, 387 u.s. 1, 36 (1967); see also in re smith, 573 a.2d at 1081; gilliam v. state, 305 ark. 438, 439 (1991). 462 vol. 11:1 causing conflict the right to counsel is the most important tool for achieving accuracy; it is the glue that holds the criminal process together. 119 mandating that attorneys reveal privileged information about their clients during the course of defense does not further any of the goals of the right to counsel guarantee, but significantly interferes with the process of defense. indiana's mandatory reporting laws force some juveniles to choose whether they receive effective counsel and an accurate outcome or the free-flowing exchange of information intended by the attorney-client privilege. the supreme court has determined on several occasions there was a constructive denial of the right to effective assistance of counsel where the state had impaired defense counsel's ability to independently direct the defense.120 particularly, in geders v. united states, the court held that a judicial order preventing the defendant from consulting with his attorney during a seventeen hour overnight, occurring between his direct and cross examinations, denied him the right to counsel. 121 the court said that preventing a defendant from conferring with his counsel, when an accused would normally confer with counsel, impinged his sixth amendment right to the assistance of counsel.122 the court did, however, acknowledge the legitimate motive behind the order of preventing improper coaching prior to the prosecution's cross-examination.123 119 joshua dressler & george c. thomas iii, criminal procedure: prosecuting crime 1070 (west 4th ed. 2010). 120 see herring v. new york, 422 u.s. 853, 864-65 (1975) (holding a statute that allowed a judge to deny summation at bench trial denied a defendant, whose counsel was denied the right to be heard, the assistance of counsel under the sixth amendment); brooks v. tennessee, 406 u.s. 605, 613 (1972) (holding that a statutory requirement that defendant be the first defense witness to testify violated due process by restricting defense counsel in the planning of its case); ferguson v. georgia, 365 u.s. 570, 596 (1961) (holding that a statute rendering defendants incompetent to testify in their own defense denied defendants the right to be heard by counsel). 121 geders v. united states, 425 u.s. 80, 91 (1976). 122 d. at 91. 123 id. 2014 463 indiana health law review similar to the order in geders, indiana's mandatory reporting laws are based on a valid purpose that may result in an unlawful violation of rights; protecting children may ultimately prevent certain juvenile defendants from conferring with their attorney. this roadblock to conferring with counsel created by indiana's mandatory reporting laws has a deeper impact on the two things the conference was designed to encourage: confidentiality and attorney-client privilege.124 encouraging a juvenile client to keep information about child abuse secret from his or her attorney obstructs the right to counsel "because the candor and quality of representation are hindered."125 the court in geders determined that a conflict between a valid basis for the order and the defendant's right to consult his attorney must be resolved in favor of the sixth amendment right to counsel.126 the general principles adopted by the majority in geders are applicable to the analysis of any order barring communication between a defendant and his attorney.127 the implicit nature of the barrier caused by indiana's mandatory reporting laws should not affect the analysis of the conflict this statute causes, nor should it affect the conclusion that the conflict should be resolved in favor of the juvenile's right to counsel. "counsel's actions are usually based, quite properly, on informed strategic choices made by the defendant and on information supplied by the defendant."128 the right to effective assistance of counsel has been interpreted to "protect the confidentiality of communications between an accused and his attorney,"129 which substantially departs from the requirement of indiana's mandatory reporting laws. the current version of indiana's mandatory reporting laws may prevent a juvenile client from revealing all information necessary to effectuate a reasonable or 124 see upjohn co. v. united states, 449 u.s. 383, 389-91 (1981). 125 see albrandt, supra note 22, at 668. 126 geders, 425 u.s. at 91. 127 id. at 92 (marshall, j., concurring). 128 strickland v. washington, 466 u.s. 668, 691 (1984). 129 see united states v. henry, 447 u.s. 264, 295 (1980) (rehnquist, j., dissenting); see also dubose & morris, supra note 5, at 210. vol. 11:1464 causing conflict appropriate defense under the circumstances. when this occurs, the attorney's ability to make an informed strategic choice is significantly inhibited. if defense attorneys are constructively prevented from providing their juvenile clients with effective representation due to the current language of indiana's mandatory reporting laws, then the juvenile clients' right to effective assistance of counsel under the sixth amendment is violated. "the adversarial process protected by the sixth amendment requires that the accused have counsel acting in the role of an advocate." 130 "to satisfy the constitution, counsel must function as an advocate for the defendant, as opposed to a friend of the court."131 one of the vital elements of effective representation is the ability of defense counsel to "act independently of the government."132 while this advocacy is required, counsel is still prohibited from engaging in unethical behavior in order to provide a defense.133 this is where indiana's mandatory reporting laws create yet another conflict. while defense counsel is required to behave ethically and comport with other laws,134 like indiana's mandatory reporting laws, counsel must also advocate on behalf of his or her client. however, when these mandatory reporting laws require defense counsel to act in a manner that contradicts or conflicts with the advocacy of his or her juvenile client, these laws create a constructive denial of effective assistance of counsel. "from counsel's function as assistant to the defendant derives the overarching duty to advocate the defendant's cause and the more particular duties to consult with the defendant on important decisions and to keep the defendant informed of important developments in the course of the prosecution."135 when indiana's mandatory reporting laws 130 united states v. cronic, 466 u.s. 648, 656 (1984) (quoting anders v. california, 386 u.s. 738, 743 (1967)). 131 jones v barnes, 463 u.s. 745, 758 (1983) (brennan, j., dissenting). 132 ferri v. ackerman, 444 u.s. 193, 204 (1979). 133 cronic, 466 u.s. at 657. 134 model rules of prof'l conduct r. 1.6 (2003). 135 strickland v. washington, 466 u.s. 668 (1984). 2014 465 indiana health law review require a juvenile defense attorney to disregard his or her client's request and report suspicions of abuse, counsel ceases being an assistant or advocate of the client and becomes a "friend of the state." when such a situation arises the function and meaning behind the right to counsel guarantee disappear. a breakdown in the adversarial process occurs when a statute requires defense counsel to act as a friend of the state in a manner which conflicts with the client's wishes, discretion, and advocacy.136 2. conflict of interest indiana's mandatory reporting laws can also create a conflict of interest between defense counsel's own interest in complying with those laws and the defendant's interests. when attorneys have to make a subjective determination about whether to report suspicions of abuse or to fully advocate on behalf of their clients, the attorneys are faced with a decision about whether to protect their client's interests or their own. the attorneys' interests may include comporting with the mandatory reporting laws, avoiding criminal sanctions, or retaining their license to practice law. when the juvenile's interest is in preserving his or her secret, for whatever reason, a conflict arises. representing conflicting interests becomes suspect "because of what it tends to prevent the attorney from doing."13 7 the broad language of indiana's mandatory reporting laws can prevent attorneys from complying with their clients' direction and from effectively advocating for the clients' wishes. when a juvenile client refuses to consent to his or her attorney revealing instances of abuse or neglect, unless the attorney violates the indiana mandatory reporting laws, the attorney is prevented from complying with the client's direction. furthermore, when 136 see generally cronic, 466 u.s. at 657 (stating the defense representation did not constitute a violation of the right to effective assistance of counsel because there was no breakdown in the adversarial process). 137 id. at 661 n.28 (quoting holloway v. arkansas, 435 u.s. 475, 489-90 (1978)). vol. 11:1466 causing conflict the juvenile defense attorney merely suspects abuse or neglect, the attorney may be forced to choose between complying with indiana's mandatory reporting laws and effectively advocating on behalf of the client. representing defendants in criminal and delinquency cases requires counsel to adhere to certain basic duties, including the duty to assist the defendant, to consult with the defendant on important decisions, and to keep the defendant informed of significant developments in the case.138 the duty to assist the defendant carries with it a duty of loyalty and a duty to avoid conflicts of interest.139 both the indiana court of appeals and the united states supreme court have recognized that the right to effective assistance of counsel includes the right to have representation free from conflicts of interest. 140 there is a presumption of ineffectiveness when counsel "actively represent[s] conflicting interests."141 in cuyler v. sullivan, the supreme court determined that in order to establish that a defendant's sixth amendment right to effective counsel has been violated by a conflict of interests, the defendant must demonstrate that an actual conflict existed, and that conflict adversely affected his or her attorney's performance.142 an actual conflict exists if, during the course of representation, the defendant's interests deviate in regards to the course of representation.14 3 an adverse impact based on conflicts of interests must structurally infect the rest of the proceedings.1 44 if attorneys are conflicted between their own interests and their clients' interests, this conflict inherently spreads throughout the representation. an adverse impact may be demonstrated by showing an inconsistency between a strategy or tactic and counsel's 138 strickland, 466 u.s. at 688. 139 id 140 see woods v. state, 701 n.e.2d 1208, 1223 (ind. ct. app. 1998); wood v. georgia, 450 u.s. 261 (1981). 141 cuyler v. sullivan, 446 u.s. 335, 350 (1980). 142 id. at 350-51. 143 id. at 356. 144 woods, 701 n.e.2d at 1224. 2014 467 indiana health law review other loyalties or that an alternative strategy or tactic was not undertaken due to the conflict. 145 while some courts have rejected the two-part test established in cuyler v. sullivan, indiana courts continue to follow the formation. 146 in tate v. state, the indiana court of appeals was careful to identify the distinction between the two prongs of cuyler. the "actual conflict of interests" component refers to the competing interest arising from the representation, whereas the "adversely impacted performance" component refers to defense counsel's conduct.147 even though the analyses conducted in cuyler and tate were in regards to conflict of interests caused by the joint representation of more than one defendant, their analyses may be easily applied to the conflict caused by the over-arching language of indiana's mandatory reporting laws. indiana's mandatory reporting laws have great potential for creating a clear example of an actual conflict. when the mandatory reporting laws require an attorney to report his or her knowledge or suspicions of abuse or neglect and the attorney knows or has reason to know that the juvenile client does not want the attorney to make such a report, there develops an obvious divergence in the interests between the attorney and client in the course of representation. given the conflicting interests between the attorney and client in this scenario, counsel is inevitably placed in a situation where he or she cannot represent the interests of himself or the client without impairing the interests of the other.148 therefore, when the attorney chooses to protect his or her own interests, it can only be done at the impairment of the client's interests, causing an adverse effect and resulting in the presumption of prejudice. because a juvenile's right to counsel is rooted in the due process clause of the fourteenth amendment, due process must also be considered when assessing a juvenile's right to counsel. "due process of law is the primary and 145 id. at 1223. 146 tate v. state, 515 n.e.2d 1145, 1147 (ind. ct. app. 1987). 147 id. 148 id. 468 vol. 11:1 causing conflict indispensable foundation of individual freedom. it is the basic and essential term in the social compact which defines the rights of the individual and delimits the powers which the state may exercise."149 neither the 'civil' label given to delinquency proceedings nor the rehabilitative, as opposed to punitive, goal of the juvenile justice system shall be .a justification for refusing to provide due process protections to minors.o50 both the civil label and rehabilitative goal of the juvenile court system are means of protecting juveniles, similar to indiana's mandatory reporting laws. therefore, based on the language of the courts, protecting minors should not be a valid reason for denying them due process rights, including the right to effective assistance of counsel. "departures from established principles of due process have frequently resulted not in enlightened procedure, but in arbitrariness."15 1 indiana should not ignore the infringement its mandatory reporting laws have on the due process of juvenile defendants. the right to counsel is essential to ensuring the due process rights of juvenile defendants, maybe even more so than for adults.152 removing or limiting a juvenile's right to counsel, even under an umbrella of protection, creates injuries to the juvenile defendant that cannot be detected through the naked eye. "juvenile court history has again demonstrated that unbridled discretion, however benevolently motivated, is frequently a poor substitute for principle and procedure." 153 v. how other states have addressed the attorney as a mandatory reporter every state currently has its own variation of a child abuse reporting statute; however, these statutes vary 149 in re gault, 387 u.s. 1, 20 (1967). 150 in re kevin s., 113 cal. app. 4th 97, 109 (2003). 151 in re gault, 387 u.s. at 18-19. 152 see generally id. at 38 (using the report by the president's commission on law enforcement and administration of justice to emphasize the additional impact that counsel has in juvenile cases). 153 id. at 18. 2014 469 indiana health law review widely from state to state.154 the majority of states have taken a combination approach to their mandatory reporting statutes and combine professionally mandated reporting with permissive reporting. thirty-five states require persons in certain professions to report their suspicions of abuse or neglect.155 these persons are referred to as professionally mandated reporters because the duty to report occurs through their occupation. generally, these occupations include those professions that are likely to have regular contact with children; often this includes social workers, teachers and other school personnel, physicians and other health-care workers, mental health professionals, child care providers, medical examiners or coroners, and law enforcement officers. 156 of those thirty-five states, twenty-six states also include permissive reporting statutes which provide that anyone who is not a professionally 154 see dubose & morris, supra note 5, at 210; albrandt, supra note 22, at 658. 155 see ala. code § 26-14-3 (2013); alaska stat. § 47.17.020 (2013); ariz. rev. stat. ann. § 13-3620 (2013); ark. code ann. § 12-18-401 (2013); cal. penal code § 11166 (west 2013); colo. rev. stat. § 19-3304 (2013); conn. gen. stat. ann. § 17a-101a (2013); ga. code ann. §19-7-5 (2013); haw. rev. stat. ann. § 350-1.1 (west 2013); idaho code ann. § 16-1605 (2013); 325 ill. comp. stat. 5/4 (2013); iowa code ann. § 232.69 (west 2013); kan. stat. ann. § 38-2223 (2012); la. child. code ann. art. 603, 609 (2012); me. rev. stat. ann. tit. 22, § 4011-a (2013); md. code ann. fam. law § 5-704 (2013); mass. gen. laws ann. ch. 119, § 51a (west 2013); mich. comp. laws ann. § 722.624 (west 2013); minn. stat. ann. § 626.556 (west 2013); miss. code ann. § 43-21-353 (west 2013); mo. rev. stat. § 210.115 (2013); mont. code ann. § 41-3201 (west 2013); nev. rev. stat. ann. § 432b.220 (west 2013); n.y. soc. serv. law § 413 (mckinney 2013); n.d. cent. code ann. § 50-25.1-03 (west 2013); ohio rev. code ann. § 2151.421 (west 2013); or. rev. stat. ann. § 419b.010 (west 2013); 23 pa. cons.stat. ann. § 6311 (west 2013); s.c. code ann. § 63-7-310 (2013); s.d. codified laws § 26-8a-3 (2013); vt. stat. ann. tit. 33, § 4913 (2013); va. code ann. § 63.2-1509 (2013); wash. rev. code § 26.44.030 (2013); w. va. code ann. § 49-6a-2 (west 2013); wis. stat. § 48.981 (2013). 156 children's bureau , u.s. dep't of health and human servs., child welfare information gateway: mandatory reporters of child abuse and neglect (2012), available at https://www.childwelfare.gov/systemwidellawspolicies/statutes/manda. cfm. 470 vol. 11:1 causing conflict mandated reporter may report suspected abuse;15 7 six states specifically include attorneys as mandated reporters,15 8 but two of those include only prosecuting or district attorneys. 159 wisconsin stands alone by expressly allowing permissive reporting for attorneys.160 on the other hand, fifteen states have enacted statutes similar to indiana's and require that any or all individuals shall or must make such reports.161 of these fifteen states, six states specifically exempt communications covered by the attorney-client privilege,162 while two specifically 157 see ala. code § 26-14-4 (2013); alaska. stat. § 47.17.020 (2013); ariz. rev. stat. ann. § 13-3620 (2013); ark. code ann. § 12-18401 (2013); cal. penal code § 11166 (west 2013); colo. rev. stat. § 19-3-304 (2013); conn. gen. stat. ann. § 17a-103 (west 2013); ga. code ann. §19-7-5 (2013); haw. rev. stat. ann. § 350-1.3 (west 2013); iowa code ann. § 232.69 (west 2013); kan. stat. ann. § 38-2223 (2012); la. child. code ann. art. 603, 609 (2012); mich. comp. laws ann. § 722.624 (west 2013); minn. stat. ann. § 626.556 (west 2013); mont. code ann. § 41-3-201 (2013); nev. rev. stat. § 432b.220 (2013); n.y. soc. serv. law § 414 (mckinney 2013); n.d. cent. code ann. § 50-25.103 (west 2013); 23 pa.cons.stat. ann. § 6312 (west 2013); s.d. codified laws § 26-8a-3 (2013); vt. stat. ann. tit. 33, § 4913 (2013); va. code ann. § 63.2-1510 (west 2013); wash. rev. code § 26.44.030 (2013); w. va. code ann. § 49-6a-2 (west 2013); wis. stat. § 48.981 (2013). 158 see ark. code ann. § 12-18-402 (2013); miss. code ann. § 4321-353 (2013); nev. rev. stat. § 432b.220 (2013); n.y. soc. serv. law § 413 (mckinney 2013); n.c. gen. stat. § 7b-310 (2013); ohio. rev. code ann. § 2151.421 (west 2013). 159 ark. code ann. § 12-18-402 (2013); n.y. soc. serv. law § 413 (mckinney 2013). 160 wis. stat. § 48.981 (2013). 161 see del. code ann. tit. 16, § 903 (2013); fla. stat. § 39.201 (2013); ind. code § 31-33-5-1 (2013); ky. rev. stat. ann. § 620.030 (west 2013); neb. rev. stat. § 28-711 (2012); n.h. rev. stat. ann. § 169-c:29 ( 2013); n.j. stat. ann. § 9:6-8.10 (west 2013); n.m. stat. ann. § 32a-4-3 (west 2013); n.c. gen. stat. § 7b-301 (2012); okla. stat. ann. tit.10, § 1-2-101 (west 2013); r.i. gen. laws § 40-11-3 (2013); tenn. code ann. § 37-1-403 (2013); tex. fam. code ann. § 261.101 (west 2013); utah code ann. § 62a-4a-403 (west 2013); wyo. stat. ann. §14-3-205 (2013). 162 see del. code ann. tit. 16, § 909 (2013); fla. stat. ann. § 39.204 (west 2013); ky. rev. stat. ann. § 620.030 (west 2013); neb. 2014 471 indiana health law review abrogate the attorney-client privilege.163 in total, sixteen states exclude communication covered by attorney-client privilege from the reach of their mandatory reporting laws; however, nevada and north carolina only uphold the attorney-client privilege under limited circumstances.164 the nevada statute provides that an attorney is required to make a report unless the attorney has acquired the knowledge of the abuse or neglect from a client who is or may be accused of the abuse or neglect. 165 while prohibiting the use of any privilege as a reason for failure to make a report under its mandatory reporting laws, north carolina still retains the attorney-client privilege in any judicial proceeding where a juvenile's abuse, neglect, or dependency is in issue or in any judicial proceeding resulting from a report submitted in compliance with the mandatory reporting statute.166 it could be argued that an additional six states have excluded attorneys through implication. 167 these states have expressly abrogated similar communicative privileges that exist for professions other than attorneys, but they have chosen not to include the attorney-client privilege among those privileges that may not be used in order to prevent reporting. it can be inferred that if these states had wanted to ensure attorneys were included as mandatory reporters, they would have abrogated the attorney-client privilege when they abrogated the other privileges. examining the mandatory reporting laws of other states does not provide indiana with a precise path to follow. rev. stat. § 28-711 (2012); n.h. rev. stat. ann. § 169-c:32 (2013); r.i. gen. laws § 40-11-3 (201387 u.s 3). 163 okla. stat. tit. 10, § 1-2-101 (2013); wyo. stat. ann. § 14-3-210 (2013). 164 nev. rev. stat. ann. § 432b.220(4)(i) (west 2013); n.c. gen. stat. ann. § 7b-310 (west 2012). 165 nev. rev. stat. ann. § 432b.220 (west 2013). 166 n.c. gen. stat. ann. § 7b-310 (west 2013). 167 alaska. stat. § 47.17.20 (2013); colo. rev. stat. § 19-3-304 (2013); me. rev. stat. ann. tit. 22, § 4011-a (2013); minn. stat. ann. § 626.556 (west 2013); s.d. codified laws § 26-8a-15 (2013); tenn. code ann. § 37-1-403 (2013). 472 vol. 11:1 causing conflict nonetheless, it does open the door for possibilities to refine the language of indiana's mandatory reporting laws. vi. what indiana could do to rectify the problem based on the review and discussion of how mandatory reporting laws have been addressed in other states, indiana has several options for relieving the conflict caused by the current statute while still retaining strict and effective mandatory reporting laws. among the options are permissive reporting, exceptions to mandatory reporting, and the exclusion of attorneys as mandated reporters. these options all narrow, in varying degrees, the sweeping language of the current indiana statute. a. permissive reporting instead of requiring that any individual shall make a report,16 8 indiana could amend its child abuse reporting statute to simply allow persons who have reason to believe a child is being abused to make a report. by stating that individuals may report suspected abuse, indiana would diminish the confusion surrounding its current mandatory reporting statute and permit attorneys to use their discretion when instances of abuse are revealed during the course of representation. permissive reporting appears to be the most relaxed approach to mandatory reporting; however, this approach has several benefits aside from resolving the confusion surrounding the current statute. first, it would allow attorneys to use their discretion to determine how best to cope with their client's circumstances. the attorney may use his or her judgment to evaluate the situation and determine whether or not to make a report based on the client's age and maturity level; the type, severity, and frequency of the abuse; and the client's reasons for not wanting the abuse reported (e.g. the client may be protecting a parent or sibling from being abused also). this also permits the attorney time to counsel 168 see ind. code § 31-33-5-1 (2013). 4732014 indiana health law review the client to reveal the abusive situation on his or her own or consent to the attorney reporting it to the proper authorities. attorneys would also be able to engage in negotiations with the prosecutor for alternative sentencing options that could benefit the client and/or his or her family. this approach also helps to preserve the trust between the attorney and the juvenile client, and it gives the juvenile a positive view of attorneys, the law, and the justice system. fostering a positive outlook towards the juvenile justice system in juveniles is more likely to result in children who respect the laws of society and are less likely to commit crimes.169 permissive reporting encourages the open communication between the attorney and juvenile client intended by the attorney-client privilege. this open communication helps empower juveniles within the delinquency system. 170 giving a juvenile client, who is the victim of abuse, power over his or her situation and legal decisions is more likely to have a positive impact; empowering victims of abuse may help reduce future incidents of abuse.171 "empowered children are . . . more likely to stand up for themselves and remove themselves from an abusive situation,"172 leading to the ultimate goal of the mandatory reporting laws: removing children from abusive or neglectful situations. b. exceptions to mandatory reporting another possibility for indiana would be to provide exceptions to its mandatory reporting laws for situations that may not necessarily further the statutes' goals, specifically when abuse is uncovered during the defense representation of a juvenile client who does not want the abuse reported. this approach also alleviates the confusion created by indiana's current statute because it creates the 169 marrus, supra note 1, at 541, 544. 170 id. at 541. 171 see id. at 541-44. 172 id. at 544-45. 474 vol. 11-1 causing conflict enumeration of the specific situations in which an attorney will not be required to make a report under the statute; providing specific exceptions to the mandatory reporting laws has the benefit of providing clarity to indiana's attorneys. this objective approach removes the attorney discretion allowed for in the permissive reporting approach; either the attorney/client situation meets one of the enumerated exceptions or it does not. this approach, however, has the downside of requiring the legislature to make subjective determinations about a multitude of situations in which the mandatory reporting statute may not be wholly beneficial. it is possible, even likely, that the legislature would not be able to include all possible scenarios which should be excluded. permissive reporting would be the less painstaking way of accomplishing this goal; nevertheless, if permissive reporting seems insufficient, the legislature has the option of excluding attorneys from the mandatory reporting laws. c. exclusion ofattorneys as mandated reporters 1. full exclusion the most commonly used form of attorney exclusion appears to be the express preservation of the attorney-client privilege; most states excluding attorneys either expressly retain or prohibit the exclusion of the attorney-client privilege from those privileges abrogated under the mandatory reporting statute.173 this approach works with most mandatory reporting statutes, whether they contain professionally mandated reporters or not. even those states 13 see ala. code § 26-14-10 (2013); ariz. rev. stat. ann. § 133620 (2013); del. code ann. tit. 16, § 909 (2013); fla. stat. ann. § 39.201 (west 2013); ky. rev. stat. ann. § 620.030 (west 2013); mich. comp. laws ann. § 722.631 (west 2013); mo. rev. stat. § 210.140 (2013); mont. code ann. § 41-3-201 (2013); neb. rev. stat. § 28-711 (2013); n.h. rev. stat. ann. § 169-c:32 (2013); n.d. cent. code ann. § 50-25.1-10 (west 2013); or. rev. stat. § 419b.040 (2013); 23 pa. cons. stat. § 6311 (2013); r.i. gen. laws ann. § 40-11-3 (west 2013); s.c. code ann. § 63-7-420 (2013); w. va. code ann. § 49-6a-7 (west 2013). 4752014 indiana health law review that do not include professionally mandated reporters, like indiana, often include an abrogation provision in their statutes where certain professional privileges may be retained or abolished.174 the full exclusion of attorneys as mandated reporters allows indiana to retain its narrow mandatory reporting laws while affirmatively eliminating the confusion caused by the current version of the statute. by retaining the any individual shall report language of the statute, indiana's laws would remain more stringent than its permissive counterparts. however, by explicitly preserving the attorney-client privilege, indiana will have effectively reconciled the conflict created by its current version. maintaining the attorney-client privilege with a juvenile client will present many of the benefits discussed with permissive. reporting: preserving the trust between the attorney and the juvenile client, giving the juvenile a positive view of those in the justice system, giving a juvenile client power and control over his or her situation, and permitting the attorney time to counsel his or her client to reveal the abusive situation on his own. 2. limited exclusion if the first three options reveal to be too narrow for the indiana legislature, it could follow in the footsteps of arkansas and new york to maximize the amount of appropriate mandated reporters and still prevent the confusion and conflicts arising from the current mandatory reporting laws. the state of arkansas provides a list of professionally mandated reporters who are required to report suspected child maltreatment. 175 this statute specifically proscribes prosecuting attorneys as professionally mandated reporters, but does not include defense attorneys among those required to report.176 174 see ind. code § 31-33-5-1 (2013); id. § 31-32-11-1. 175 ark. code ann. § 12-18-402 (2013). 176 id. § 12-18-402. 476 vol. 11:1 causing conflict however, anyone not listed as a professionally mandated reporter mayreport suspicions of child abuse.177 the state of new york has enacted a similar statute, including district attorneys or assistant district attorneys among its list of professionally mandated reporters. 78 while neither statute specifically excludes defense attorneys, that is the implication from the inclusion of the "prosecuting" language. like arkansas, new york also allows for permissive reporting for any other person who has reason to believe a child is being abused or neglected.179 because indiana's current statute currently does not contain an express list of professionally mandated reporters in which to include only prosecuting or district attorneys, indiana could accomplish this same goal by expressly excluding defense attorneys from the mandatory reporting laws. this type of approach has the benefit of removing the possible conflicts incurred by defense attorneys, while still retaining a significant portion of the legal profession under the mandatory reporting laws. vii. conclusion child abuse and neglect are serious societal problems that should not be taken lightly. children should be afforded as many protections as society can muster, but not at the expense of their constitutional rights or by undermining the attorney-client privilege. when this occurs, we may injure the children whom we are trying to protect. indiana is in the minority when it comes to the treatment of its mandatory reporting laws. the goal of protecting children should not dissuade us from reevaluating and adjusting laws that no longer function as intended. "[tihe claimed benefits of the juvenile process should be candidly appraised. neither sentiment nor folklore should cause us to shut our eyes. .. ."180 177 id. § 12-18-401. 178 n.y. soc. serv. law § 413 (mckinney 2013). 179 id. § 414. 180 in re gault, 387 u.s. 1, 21 (1967). 2014 477 indiana health law review as the oldest of the privileges for confidential communications known to the common law, the attorneyclient privilege should not be so easily annulled as it has been done in indiana's mandatory reporting laws. as a privilege "founded upon the necessity, [and] in the interest and administration of justice,"18 1 the attorney-client privilege should be preserved but for a showing of a heavy burden. indiana's mandatory reporting laws could not meet such a burden because the intended goals would continue to be met even if the attorney-client privilege was expressly retained with the statutes. "lawyers in criminal cases are necessities, not luxuries."182 juveniles, like adults, have the right to have their attorney advocate to their fullest benefit. the presence of defense attorneys is so essential because they are the means through which all other rights of the juvenile are secured.183 the juvenile defense attorney should be free to weigh the consequences of disclosure against the need for agency intervention, and determine the path most likely to benefit the client; these benefits can include the juvenile developing a positive outlook towards the criminal justice system, the juvenile receiving much needed treatment to which he or she otherwise would not have been exposed, and reducing the amount of minors who return to the juvenile or criminal justice system. in order to alleviate confusion and resolve the conflict surrounding its mandatory reporting laws, indiana should amend the current statute to reinforce the attorney-client privilege and avoid possible sixth amendment violations. "[good intentions do not themselves obviate the need for criminal due process safeguards in juvenile courts." 184 the good intentions of indiana's mandatory reporting laws do not negate the necessity of a juvenile's constitutional rights or the historic importance of the attorney-client privilege. 181 upjohn co. v. united states, 449 u.s. 383, 389 (1981) (quoting hunt v. blackburn, 128 u.s. 464, 470 (1888)). 182 united states v. cronic, 466 u.s. 648, 653 (1984) (quoting gideon v. wainwright, 372 u.s. 335, 344 (1963)). 183 id. 184 in re winship, 397 u.s. 358, 365-66 (1970). 478 vol. 11:1 microsoft word 1-volume xii masthead.docx rethinking the tort liability system and patient safety: from the conventional wisdom to learning from litigation chih-ming liang, s.j.d.∗ i. introduction .................................................................. 328 ii. regulating patient safety in the era of the affordable care act ....................................................... 332 iii. the conventional wisdom on tort and patient safety ................................................................................. 340 a. inability to deter and compensate ............................ 344 b. discouraging systemic learning .............................. 346 iv. from conventional wisdom to learning from litigation ........................................................................... 349 a. how providers learn from litigation ....................... 350 1. strengthening reporting systems ......................... 350 2. finding the root cause of individual incidents .... 352 3. identifying the patterns and trends of errors ...... 354 b. the changing culture of healthcare organizations .. 358 c. disclosure, apology, and communication-andresolution ........................................................................ 360 v. tort reform in the age of learning from litigation: early resolution via communication-and-resolution programs as a foundation for the future .................. 367 a. overcoming barriers against early resolution ....... 370 b. reforming the tort litigation system ...................... 372 c. incorporating crp ideas into the pre-trial settlement process ............................................................................. 377 vi. conclusion .................................................................. 380 *∗assistant professor, graduate institute of health and biotechnology law, taipei medical university. the article was first presented at the law and society 2014 conference with the title litigation and patient safety: how malpractice claims help healthcare organizations learn from mistakes. i would like to express my sincere gratitude to louise trubek for offering critical suggestions. i also owe debt to elizabeth mertz and pilar ossorio for helping me obtain irb approval for the interview. in addition, i thank the editors of the indiana health law review for editorial assistance. http://dx.doi.org/10.18060/18965 328 indiana health law review vol. 12:1 i. introduction this paper examines the relationship between the current tort-based medical liability system and patient safety. the predominant view, which critics refer to as the conventional wisdom, suggests that tort litigation hinders the pursuit of patient safety.1 the core rationale for the conventional view is that the threat of litigation discourages medical professionals from being open and transparent about their mistakes.2 without openness and transparency, it is difficult to develop a culture of patient safety in which providers actively learn from mistakes and improve upon them.3 however, the validity of this assumption has been challenged in recent years. 1 see generally david hyman & charles silver, the poor state of health care quality in the us: is malpractice liability part of the problem or part of the solution, 90 cornell l. rev. 893 (2005) (arguing that the conventional wisdom has never been proven and the tort liability system may actually contribute to the pursuit of patient safety by internalizing the cost of preventable medical errors and in this way generating economic pressure on providers to change their behaviors). see also joanna c. schwartz, a dose of reality for medical malpractice reform, 88 n.y.u. l. rev. 1224, 1239-43 (2013) (outlining the underlying concerns of the conventional wisdom that tort litigation prevents transparency and communication in the healthcare system). 2 see schwartz, supra note 1. “to err is human,” for example, mentioned that “[p]atient safety is also hindered through the liability system and the threat of malpractice, which discourages the disclosure of errors. the discoverability of data under legal proceedings encourages silence about errors committed or observed. most errors and safety issues go undetected and unreported, both externally and within health care organizations.” inst. of med., to err is human: building a safer health system 43 (1999) [hereinafter to err is human]. also, david studdert, michelle mello, and troyen brennan in their article, medical malpractice, indicated that “[t]here is a deep-seated tension between the malpractice system and the goals and initiatives of the patient-safety movement. at its root, the problem is one of conflicting cultures: trial attorneys believe that the threat of litigation makes doctors practice more safely, but the punitive, individualistic, adversarial approach of tort law is antithetical to the nonpunitive, systems-oriented, cooperative strategies promoted by leaders of the patient-safety movement.” david m. studdert et al., medical malpractice, 350 new eng. j. med. 283, 286 (2004). 3 id. http://dx.doi.org/10.1056/nejmhpr035470 2015 rethinking the tort liability system and patient safety 329 david hyman and charles silver criticized the conventional wisdom as unproven in their 2005 article, the poor state of health care quality in the us: is malpractice liability part of the problem or part of the solution (hereinafter the poor state).4 rather, evidence suggests that patient safety can actually benefit from the tort liability system.5 in particular, hyman and silver pointed 4 see hyman & silver, supra note 1, at 914-17 (arguing that the conventional wisdom had been widely embraced only due to its seeming plausibility). 5 in the poor state, hyman and silver outlined several pieces of evidence challenging the conventional wisdom. examples of these pieces of evidence include the following. first, the famous harvard medical practice study found an inverse relationship, though statistically insignificant, between “the magnitude of the malpractice risk and the rate of negligent injuries.” second, anesthesia, traditionally viewed as one of the most risky specialties, has successfully overcome rising malpractice costs by making the practice safer and more reliable. in addition, hyman and silver indicated that recent improvements in safety and quality achieved by veteran affairs hospitals could in part be attributed to the external pressure of malpractice litigation. also, there had been no conclusive evidence on the existence of defensive medicine, and the medical community, despite the lack of tort reform in recent years, has continued to disclose information to patients and investigate adverse incidents. id. at 916-23, 933-47. see generally troyen brennan et al., incidence of adverse events and negligence in hospitalized patients: results of the harvard medical practice study i., 324 new eng. j. med. 370 (1991) (commonly referred to as the harvard medical practice study) (estimating that 3.7% of hospitalizations in the studied population developed adverse events, 26% of which were the result of substandard care). other observers have also increasingly cautioned that the fear of lawsuits may be blown out of proportion. see marlynn wei, doctors, apologies, and the law: an analysis and critique of apology laws, student scholarship papers, 36 (2006), available at http://digitalcommons.law.yale.edu/student_papers/30 (last visited jan. 12, 2015) (noting that physicians tend to overestimate the risk of litigation). lucian leape also argues that “[t]he fear of litigation may also be overblown.” lucian leape, patient safety: reporting of adverse events, 347 new eng. j. med. 1633, 1635 (2002). see also, bernard s. black et al., stability, not crisis: medical malpractice claim outcomes in texas, 1988-2002, 2 j. emp. l. stud. 207 (2005) (arguing that the frequency of malpractice claims and the amount of jury awards were actually stable during the research period); catherine cravens and jo anne l. earp, disclosure and apology: patient-centered approaches to the public health problem of medical error, 70 n.c. med. j. 140, 142 http://dx.doi.org/10.1056/nejm199102073240604 http://dx.doi.org/10.1056/nejmnejmhpr011493 http://dx.doi.org/10.1111/j.1740-1461.2005.00050.x 330 indiana health law review vol. 12:1 to stories of the anesthesia profession, which transformed itself into one of the safest medical specialties in response to rising malpractice costs in the 1980s, as proof that the external pressure of malpractice costs can lead to safety and quality improvement.6 in her 2013 article, a dose of reality for medical malpractice reform (hereinafter a dose of reality), joanna schwartz also criticized the conventional wisdom as not reflecting the reality of medical practice. 7 schwartz presented the result of a combined interview/survey study on healthcare providers’ attitudes toward medical malpractice.8 the results suggested a changing industry in which healthcare providers increasingly embrace the value of transparency and utilize the process of malpractice dispute resolution to identify and strengthen weak spots of the delivery system.9 this discovery lent further credence to hyman and silver’s critique of the conventional wisdom, as it supports the idea that the pressure of litigation may have prompted providers to engage in safety and quality improvement activities. this paper refers to the trend discovered by schwartz, where providers increasingly view litigation as an opportunity to improve patient safety, as the phenomenon of learning from litigation (lfl). 10 the paper then reviews literature related to this emerging phenomenon, and outlines how healthcare organizations actually turn litigation into safety lessons. examples of these specific learning activities include using claim data to: 1) strengthen (mar./apr. 2009) (observing that “[p]erhaps the greatest barrier to full disclosure is the fear of legal repercussions, including medical malpractice suits. to date, however, we could find no evidence to suggest that full disclosure increases the risk of negative consequences for physicians.”). 6 hyman & silver, supra note 1, at 917-23. 7 see generally schwartz, supra note 1 (observing that tort litigation today may actually be playing a productive role in revealing valuable information about patient safety). 8 for the study methodology, see id. at 1246-51. 9 id. 10 joanna c. schwartz, leaning from litigation, n.y. times (mar. 16, 2013). 2015 rethinking the tort liability system and patient safety 331 error reporting systems; 2) identify causes and develop solutions to individual adverse events; and 3) combine individual claim data into larger datasets that can be used to identify the patterns and trends of error.11 by outlining these learning activities, this paper attempts to shed new light on the current tort reform debate and proposes a new reform direction that emphasizes making the tort system a more conducive vehicle to encourage these activities. this paper consists of the following: section ii sets the stage for the debate over the conventional wisdom by embedding the concept of patient safety in the broader context of the patient safety movement (psm) and the patient protection and affordable care act (aca).12 the discussion is followed by section iii, which points out that the aca adopts an indirect approach to tort reform that encourages state demonstration projects to identify alternatives to the current tort liability system.13 the paper argues that such an indirect approach is a logical extension of the conventional wisdom that believes tort litigation actually harms patient safety. section iii then outlines the underlying arguments that are commonly used to support the conventional wisdom.14 section iv explores the phenomenon of lfl as a counterargument to the conventional wisdom. in particular, it highlights the role of the campaign to promote disclosures and apologies as one of the driving forces behind the growing trend of lfl.15 a central focus of this campaign is the communication-and-resolution program (crp). the communication-and-resolution program refers to a claim management model pioneered by healthcare organizations such as the university of michigan health system (umhs). 16 the model typically consists of four basic elements: 1) immediate disclosure of harm; 2) timely 11 see infra part iv.a. 12 patient protection and affordable care act, pub. l. no. 111–148, 124 stat. 119 (2010). 13 see infra part iii. 14 see infra part iii.a and iii.b. 15 see infra part iv.c. 16 see infra part iv.c. 332 indiana health law review vol. 12:1 expression of sympathy and apology; 3) commitment to investigation and prevention efforts; and 4) a quick offer of compensation if negligence is discovered during investigation.17 pioneers of crps saw not only the number of claims and payouts reduced, but also an improvement in the adverse event investigation process.18 based on these findings, the final section of the paper argues that in the era of lfl, the best approach to reforming the medical liability litigation system is actually to encourage early resolution via crps to prevent disputes from developing into legal claims. the paper argues that such a strategy has multiple advantages over other tort reform proposals. it is relatively politically feasible, it has the potential to reduce providers’ financial burdens, and expand the pool of patients eligible for compensation. most importantly, the strategy helps create a better culture of safety in which providers are motivated to learn from errors and disputes. the proposed approach, in turn, can be assisted by policies that: 1) reward providers’ commitment to patient safety and lower the cost of litigation discovery; 2) help overcome the cultural, legal, economical barriers against the idea of early resolution; and 3) incorporate crp ideas into the pre-trial settlement negotiation process. ii. regulating patient safety in the era of the affordable care act today, the pursuit of patient safety has become one of the guiding principles for modern healthcare management.19 the growing significance of patient safety 17 see infra part iv.c. 18 thomas gallagher et al., disclosing harmful medical errors to patients, 356 n. engl. j. med. 2713, 2716 (2007) (discussing that the university of michigan health system, in particular, saw “the cost and frequency of litigation decreased substantially in the 5 years after the implementation of an open-disclosure program, with annual litigation expenses reduced from $3 million to $1 million and the number of claims decreasing by more than 50%.”). 19 see to err is human, supra note 2, at 18 (identifying the three domains of healthcare quality as: (1) safe care; (2) “practice that is consistent with current medical knowledge;” and (3) customization); http://dx.doi.org/10.1056/nejmra070568 2015 rethinking the tort liability system and patient safety 333 can be traced back to the groundbreaking 1999 institute of medicine report, to err is human.20 the report defined patient safety as “freedom from accidental injury,”21 and indicated that between 44,000 and 98,000 people die from preventable medical errors every year. 22 such haunting statistics helped raise public awareness of the preventable error pandemic, and the influential patient safety movement was born. as the catalyst for the movement, to err is human and its sequel, crossing the quality chasm, 23 outlined some basic ideas of the psm, many of which are still being pursued today. the cornerstone for these ideas is a different understanding of why errors occur. 24 human inst. of med., crossing the quality chasm: a new health system for the 21st century (2001) [hereinafter crossing the quality chasm] (stating that its predecessor, to err is human, focused on the specific quality concern of patient safety, whereas the 2001 report “focuse[d] more broadly on how the healthcare delivery system can be designed to innovate and improve care”). 20 see generally to err is human, supra note 2 (exposing the severity and prevalence of preventable medical errors and advocating a systematic approach to these errors). 21 id. at 4, 18. 22 id. at 1, 26. 23 see generally crossing the quality chasm, supra note 19 (outlining recommendations to redesign the healthcare system in ways that encourage innovation and improve healthcare quality). 24 “to err is human” explored the complex dynamics behind medical errors and arguing that “preventing errors and improving safety for patients require a systems approach in order to modify the conditions that contribute to errors (emphasis added).” to err is human, supra note 2, at 49-68. to do so, “to err is human” made a distinction between active and latent errors. active errors refer to incidents that “occur at the level of the frontline operator, and their effects are felt almost immediately.” latent errors, conversely, “tend to be removed from the direct control of the operator and include things such as poor design, incorrect installation, faulty maintenance, bad management decisions, and poorly structured organizations.” to err is human, supra note 2, at 55 (taking air traffic accident as an example and stating that “[t]he active error is that the pilot crashed the plane […, while] the latent error is that a previously caused the plane to roll unexpectedly in a way the pilot could not control and the plane crashed”). with this distinction, “to err is human” proposed a system approach to medical errors, which gives priority to identifying and 334 indiana health law review vol. 12:1 nature typically attributes errors to individual negligence. however, to err is human stresses that errors are often the consequence of flawed system design instead of purely individual misbehavior.25 hence there is a limitation on how much blaming individuals can benefit the pursuit of patient safety. 26 therefore, a more efficient strategy to achieve real and sustainable reductions in error rates is to utilize preventable errors as opportunities to identify the hidden system factors that are the root cause of the eradicating latent errors that are caused by ill-designed system over punishing individuals who commit visible active errors. the report argued that in a complex setting such as the healthcare system, individuals, no matter how professional they are, have only limited control over the whole process. however, the dominant responses to medical errors tend to focus on preventing recurrence of the active error by punishing people who commit that specific mistake. although punitive measures are necessary in situations such as intentional misconduct, punishment alone often is unable to prevent recurrence. countering this human instinct, the report declared that “[b]laming an individual does not change these factors and the same error is likely to recur.” also, “[p]eople working in health care are among the most educated and dedicated workforce in any industry. the problem is not bad people; the problem is that the system needs to be made safer.” to err is human, supra note 2, at 49. the reason why punishing individuals has limited impact on safety and quality is because large system breakdowns often result from different latent errors coming together and compounding each other in specific and often unexpected circumstances. “since the same mix of factors is unlikely to occur again, efforts to prevent specific active errors are not likely to make the system any safer.” from this perspective, it is the latent errors that are greater threats to patient safety, because they can, in unexpected scenarios, result in other active errors. the report therefore concluded that “[d]iscovering and fixing latent failures, and decreasing their duration, are likely to have a greater effect on building safer systems than efforts to minimize active errors at the point at which they occur.” to err is human, supra note 2, at 56. 25 id. 26 id. 2015 rethinking the tort liability system and patient safety 335 mistakes.27 it is these lessons, psm activists believe, that will lead to real reform of the current system.28 this paper refers to such a strategy as systemic learning, and the million-dollar question for psm activists has long been how to institutionalize learning within healthcare organizations. the historical—and still widely used— mechanisms for learning from prior mistakes in healthcare organizations have been morbidity and mortality conferences (m&m) as well as clinical peer review. however, neither was viewed as sufficiently effective at the dawn of the psm.29 as a result, psm activists initially turned their attention to error reporting systems as a promising alternative.30 the idea behind this proposal is to replicate the success of the aviation safety reporting system (asrs), a voluntary and no-blame system that many believe helps 27 id. at 49 (“preventing errors and improving safety for patients require[s] a systems approach in order to modify the conditions that contribute to errors.”) (emphasis added); see also crossing the quality chasm, supra note 19, at 4, 8, 62, 78-79 (promoting the idea that safety and quality are a systemic property). 28 id. 29 the major critique of m&m meetings has been that they are often conducted in ways that avoid tough issues. the reason for such avoidance is to reduce interpersonal confrontations that may result from publicly discussing the potential role of a colleague in an adverse event. see jay d. orlander et al., the morbidity and mortality conference: the delicate nature of learning from error, 77 academic med. 1001, 1004 (2002) (observing that in m&m meetings, “[t]he ‘tough issues’ are often avoided because it is inherently difficult to face mistakes”). the clinical peer review, on the other hand, has often been conducted following a paradigm called quality assurance that emphasizes punishing individuals. critics believe this paradigm actually pushes medical professionals away from the ideal of ensuring better safety in the healthcare delivery system. see marc t. edwards et al., a longitudinal study of clinical peer review’s impact on quality and safety in u.s. hospitals, 58 j. health mgmt. 369 (2013) (examining whether hospitals in the us have been shifting away from the quality assurance model of peer review for the past 30 years, and moving toward the quality improvement model that is more consistent with the systemic approach to medical error). 30 to err is human, supra note 2, at 8-10 (recommending the establishment of a nationwide mandatory reporting system and encouraging the development of voluntary reporting efforts). http://dx.doi.org/10.1097/00001888-200210000-00011 336 indiana health law review vol. 12:1 make aviation the safest mode of transportation today.31 since it was established, the asrs has been widely credited for successfully bringing down the accident rate in the aviation industry.32 following the example of the asrs, to err is human recommended the federal government establish a national mandatory reporting system that targets serious events, while in the meantime encourages the establishment of multiple voluntary reporting systems that focus on less serious incidents and “near misses,” events that involve human errors but do not lead to injuries or other consequences.33 however, the federal government did not follow the recommendation to establish a national mandatory reporting system. the federal government largely leaves states and the private sector to take the initiative. today, there are four major types of reporting systems that co-exist in the us, with each covering different categories of events and offering different degrees of legal protection for reported information:34 1) intra-organizational systems; 2) state-run systems, most of which require mandatory reporting of listed events;35 3) nationwide voluntary systems, the most famous example of which is the sentinel event report system (sers) run by the joint commission for 31 the aviation safety reporting system, http://asrs.arc.nasa.gov/index.html (last visited feb. 12, 2015). see also, stephen c. redhead, cong. research serv., rl31983, health care quality: improving patient safety by promoting medical errors reporting 12 (2005). 32 stephen c. redhead, supra note 31, at 9-10; to err is human, supra note 2, at 95-97. 33 to err is human, supra note 2, at 9-10, 87. 34 stephen c. redhead, supra note 31, at 4-9. 35 see, jill rosenthal & mary takach, nat'l acad. for state health policy, state health policy survey report: 2007 guide to state adverse event reporting systems 7 (2007), archived at http://perma.cc/v2gs-447f (discussing that as of 2007, there have been twenty-seven state run adverse-event reporting systems in place. among them, only one chose a voluntary system. the other twenty-five states and the district of columbia all have mandatory reporting requirements. furthermore, twenty-three of all these systems are supported by heightened legal protections against unwanted disclosure of reported information in the courts.). 2015 rethinking the tort liability system and patient safety 337 accreditation of health care organizations (jacho);36 and finally 4) voluntary systems run by patient safety organizations certified under the patient safety and quality improvement act of 2005 (psqia).37 for psm activists, error-reporting systems are simply the starting point for a comprehensive strategy for patient safety and healthcare quality. productive and continuous systemic learning is predicated on the ability to compare healthcare outcomes and identify trends and patterns of error. these comparisons and identifications are often made possible by using analytical tools such as advanced statistics.38 to facilitate rigorous statistical analysis, it is 36 sentinel event, the joint commission, archived at http://perma.cc/qyy7-hv7l (defining sentinel event as unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof”); see also, stephen c. redhead, supra note 31, at 1213. 37 public law no. 109-41, 119 stat. 424 (codified at 42 u.s.c. § 299 et. seq.). 38 the reliance of the patient safety movement on statistics reflects the movement’s deep intellectual connection with the philosophy of the total quality movement/continues quality improvement (tqm/cqi), a line of industrial engineering ideas that errors in production processes are often attributes of system design rather than individual misbehaviors. the origin of the tqm/cqi can be traced back to the 1920s. at the time, walter shewhart, who many credit as the pioneer of tqm/cqi, first discovered that statistical tools could be used to detect the existence and causes of unnecessary variations in product quality. shewhart observed that quality measures such as defect rates often remain relatively constant over time. this suggested that “[t]he statistical distribution of defect rates was often a highly predictable characteristic of the process of production itself,” and the existence of defects cannot always be attributed to specific causes like individual misbehaviors. troyen a. brennan & donald m. berwick, new rules: regulation, markets, and the quality of american health care 127-30 (1996); curtis mclaughlin & arnold kaluzny, defining quality improvement, in continuous quality improvement in health care: theory, implementations, and applications 21, 127 (curtis mclaughlin & arnold kaluzny eds., 3rd ed., 2006). in the field of healthcare, however, the power of statistical tools was not taken seriously until the emergence of the outcome research movement in the 1970s. a leading figure in this movement was john e. wennberg, a prominent professor at dartmouth college. wennberg was one of the pioneers in studying the phenomenon of small area variations, or the differences in the use of healthcare procedures between localities that 338 indiana health law review vol. 12:1 essential to generate and distribute large amounts of quantifiable performance data on different aspects of the healthcare delivery process. the results of these analyses, often coming in the form of clinical guidelines or best practices, will also need to be properly distributed and implemented by individual providers to yield real impact on patient safety.39 consequently, the psm is also commonly associated with the following policy items: 1) wider adoption of health information technology (hit) to modernize the documentation and sharing of medical data; 2) more cannot be justified by medical or scientific reasons. recognizing the power of statistical tools, wennberg was able to achieve “a level of precision and a sophistication of statistical adjustment in the study of these variations that left no doubt about the extraordinary pervasiveness and the lack of epidemiologic explanation for these ‘small area variations’ in the use of medical resources.” troyen a. brennan & donald m. berwick, at 117. also, see generally john e. wennberg and a. gittelsohn, small area variations in healthcare delivery: a population-based health information system can guide planning and regulatory decision-making, 182 sci. 1102 (1973) (arguing that “[e]xperience with a population-based health data system in vermont reveals that there are wide variations in resource input, utilization of services, and expenditures among neighboring communities”). wennberg’s scholarship later inspired the evidence-based medicine (ebm) movement. the central component of this movement is the promulgation and distribution of clinical practice guidelines (cpgs) that are supported by scientific research to have higher comparative effectiveness. these guidelines are often produced through systematic reviews of randomized controlled trials (rcts), a method of experimentation in which statistical analyses are conducted to examine the data and draw conclusion. see inst. of med., clinical practice guidelines we can trust 31-34 (2011) (discussing rcts as the scientific basis for ebm and cpgs). the legacy of both outcome research and ebm were later inherited by the patient safety movement, and many of their key ideas, including the reliance on statistical analyses, are still clearly visible today. 39 crossing the quality chasm, supra note 19, at ix (outlining a series of changes that will be explored in the report for achieving a better healthcare systems, which included “setting national priorities for improvement, creating better methods for disseminating and applying knowledge to practice, fostering the use of information technology in clinical care, crating payment policies that encourage innovation and reward improvement in performance, and enhancing educational programs to strengthen the healthcare workforce”). http://dx.doi.org/10.1126/science.182.4117.1102 2015 rethinking the tort liability system and patient safety 339 investment on research that measures performance and outcomes of healthcare delivery (i.e., outcome or comparative effectiveness research); 3) better utilization of the result of outcome or comparative effectiveness research to develop and disseminate clinical guidelines or best practices; and 4) reform of payment mechanisms (i.e., payfor-performance) to incentivize providers to follow these guidelines or practices developed through rigorous scientific research.40 all these policy proposals have become national policies since the passage of the american recovery and reinvestment act of 2009 (arra),41 the so-called “stimulus package,” and the patient protection and affordable care act of 2010. 42 the $19 billion arra funding for implementing electronic health records represents one of the largest it investments in us history.43 the legislation also supported comparative effectiveness research,44 a policy continued by the aca that establishes the patient-centered outcomes research institute (pcori) to oversee federal investment in such research. 45 the aca also provides various alternative performance-based payment models for providers to experiment with, the most famous one being the accountable care organization model.46 last, but not 40 id. 41 american recovery and reinvestment act of 2009, pub. l. no. 111-5, 123 stat 115 (2009). 42 patient protection and affordable care act, pub. l. no. 111–148, 124 stat. 119 (2010). 43 electronic medical records, massachusetts medical society, archived at http://perma.cc/6s9t-husw. 44 american recovery and reinvestment act of 2009, pub. l. no. 111-5, § 804, 123 stat 115, 187, 42 usc 299b–8 (2009) (establishing a federal coordinating council for comparative effectiveness research); american recovery and reinvestment act of 2009, pub. l. no. 111-5, 123 stat 115, 176-77 (appropriating funding for the agency for healthcare research and quality to support comparative effectiveness research). 45 patient protection and affordable care act, public law 111-148, § 6301, 124 stat. 119, 727, 42 u.s.c. § 1320e. 46 the essential idea of the aco model is to combine quality benchmarking with the global budget system, a system in which providers operate under the constraint of a pre-determined expenditure target. in other words, if a provider saves money by reducing the cost 340 indiana health law review vol. 12:1 least, the massive legislation creates “four streams of pressure that converge toward measurable and specific standards of care in practices.” 47 the four streams of pressure include: 1) the research and development of outcome measures; 2) the research and development of best practices; 3) the development and dissemination of clinical practice guidelines based on these research findings; and finally 4) all these findings, including research on outcomes, best practices and guidelines, are required to be quickly disseminated to practice settings.48 iii. the conventional wisdom on tort and patient safety compared with other policy proposals of the psm, one policy field where there has been a lack of clear national direction is tort law. the aca does not contain provisions to make national policies of traditional tort reform proposals, which continue to be popular at the state level.49 many of while meeting certain quality standards, the provider may keep some of the savings as a reward. for additional information on various attempts under the aca, including the aco model, to increase the integration and coordination of healthcare and their implication on malpractice liability, see barry furrow et al., health care reform supplement materials 97-101 (2012 ed.). 47 barry furrow, regulating patient safety: the patient protection and affordable care act, 159 u. pa. l. rev. 1727, 1770 (2011). 48 id. at 1770-71. 49 observers typically divide various tort reform proposals into two generations. see generally eleanor d. kinney, malpractice reform in the 1990s: past disappointments, future success?, 20 j. health pol. pol’y & l. 99 (1995) (introducing different approaches under the two generations of reforms and indicating that, while the second generation reforms seem to hold greater promise, the federal and state legislation has centered on the first generation reforms and been reluctant to pursue 2nd generation policies). see also rogan kersh, medical malpractice and the new politics of health care, in medical malpractice and the u.s. health care system 44-49 (william sage & rogan kersh ed., 2006) (introducing the historical context of the malpractice reform debate, including its relation with the political landscape in the state and federal level). the first generation reforms mostly follow the example of state responses, in particular that of the state of california, to the sudden spike in malpractice insurance premiums in the 1970s, also known as 2015 rethinking the tort liability system and patient safety 341 these proposals are modeled on california’s medical injury compensation reform act of 1975 (micra). 50 these proposals, most notably caps on non-economic and/or punitive damages, typically “aim to change the behavior of litigants…by making it more difficult for claimants to sue or try to control the frequency or severity of claims.”51 instead of making these proposals national policy, the aca adopts an indirect approach to tort reform. the main aca provision regarding tort reform, section 10607, encourages the states to find viable alternatives to the the first malpractice crisis. the second-generation reforms emerged primarily in the late 1980s and early 1990s. eleanor kinney observed that “[t]his generation includes proposals developed by scholars and interested constituencies that are explicitly intended to make the malpractice adjudication and compensation systems more rational and efficient without necessarily controlling claim frequency or severity (emphasis added).” kinney, supra note 49, at 100. examples include proposals like: (1) use of medical practice guidelines to set the standard of care; (2) enterprise liability; (3) mandatory alternative dispute resolution mechanisms; and (4) various no-fault approaches. kinney, supra note 49, at 103 (figure 2). the current status of malpractice reform can be summarized by the following observations. first, compared with the state governments, the federal government is relatively silent on malpractice reform. rogan kersh wrote in 2006 that “[s]ince malpractice first appeared on political agendas in the 1960s, congress and successive administrations have been unable to decisively address the issue.” kersh, supra note 49, at 43. the second observation is that policy makers tend to favor the firstgeneration reforms over the second-generation ones. kinney pointed out that “nearly all states adopted some first-generation reforms in the 1970s and 1980s, and they continue to do so in the 1990s.” kinney, supra note 49, at 110. at the same time, state implementation of secondgeneration reforms, such as the use of guidelines to establish the standard of care and the no-failure compensation systems, has either been delayed by legal challenges or failed to produce promised results. kinney, supra note 49, at 110-12. these developments led to a reform approach that heavily relies on state-led efforts, with the emphasis on first-generation reforms aiming at controlling the frequency or severity of tort compensation claims. the results of such an approach have been disappointing, as empirical studies indicated that first-generation reform legislations generally had an insignificant impact on malpractice insurance premium levels. kersh, supra note 49, at 46. 50 cal. civ. code §§ 3333.1, 3333.2. 51 kinney, supra note 49, at 101. 342 indiana health law review vol. 12:1 existing tort-based medical liability system.52 section 10607 of the aca is titled state demonstration programs to evaluate alternatives to current medical tort litigation.53 the provision authorizes the secretary of the department of health and human services (dhhs) to “award demonstration grants to states for the development, implementation, and evaluation of alternatives to current tort litigation for resolving disputes over injuries allegedly caused by health care providers or health care organizations.”54 there are two popular narratives to explain the indirect approach of section 10607: the interest group politics narrative and the patient safety movement narrative. during the legislative fight for the aca, the narrative of interest group politics dominated public discourse.55 under this narrative, section 10607 is viewed by critics as a political gesture by the ruling democratic party to pretend they are committed to the important issue of tort reform, while in reality their real goal was shielding trial lawyers, a powerful political ally of the democratic party, from republican attempts to limit patients’ access to litigation, a position supported by physician groups.56 while the narrative may have captured the political reality to a certain extent, the interest group politics narrative overlooks the important fact that section 10607 52 patient protection and affordable care act, public law 111–148, § 10607, § 399v-4, 124 stat. 119, 1009 (codified as amended in scattered sections of 42 usc 280g et seq.). 53 id. 54 id. 55 see philip k. howard, why medical malpractice is off limits, wall st. j., oct. 15, 2009, http://online.wsj.com/article/ sb10001424052970204488304574432853190155972.html (arguing that the political power of trial lawyers limited the democratic party from considering the idea of tort reforms); see also 2012 republican party platform and “tort reform”, med. malpractice lawyers (aug. 31, 2012, 11:50 am), http://medicalmalpracticelawyers.com/blog/medicalmalpractice-lawyers/2012-republican-party-platform-and-tort-reform/ (challenging the republican position that “[f]rivolous medical malpractice lawsuits have ballooned the cost of healthcare for the average american”). 56 id. 2015 rethinking the tort liability system and patient safety 343 also has its intellectual root in the psm. the effort to find alternatives to tort litigation is a logical extension of the psm idea that the tort liability system actually hurts the pursuit of patient safety.57 scholars often refer to this view as the conventional wisdom.58 at its core, the conventional wisdom is that the threat of litigation makes medical professionals hesitant to embrace openness and transparency, which in turn are the key preconditions for encouraging systemic learning.59 the following section of this paper outlines two lines of critique that support the conventional wisdom. the first line of critique is a general discussion on the inability of the tort system to achieve its institutional goals of compensation and deterrence. the second highlights specific institutional weaknesses of the litigation process that makes the tort system ill suited for learning from preventable errors. examples of these institutional weaknesses include hindsight biases and the narrow focus of causation. as a result, many psm activists believe the tort system as currently constructed reinforces the dominant medical culture that prioritizes secrecy over transparency in order to minimize the potential exposure to litigation. 57 hyman & silver, supra note 1. influenced by the conventional wisdom, many psm activists advocate for the no-trial approach to medical malpractice. the core idea of the approach is to move medical dispute resolution away from the court to ensure transparency and openness. proponents of this no-trial approach often call for state demonstration projects to experiment alternatives to the current tort liability system; see, fostering rapid advances in health care: learning from system demonstrations, inst. of med., (2002) (advocating for state demonstration projects that “would create injury compensation systems outside of the courtroom that are patientcentered and focused on safety.”); see also public law 111–148, § 10607, § 399v-4, 124 stat. 119, 1009 (codified as amended in scattered sections of 42 usc 280g et seq.) (authorizing “demonstration grants to states for the development, implementation, and evaluation of alternatives to current tort litigation for resolving disputes over injuries allegedly caused by health care providers or health care organizations.”). 58 hyman & silver, supra note 1. 59 schwartz, supra note 2. 344 indiana health law review vol. 12:1 a. inability to deter and compensate tort law has long been viewed as having two major institutional goals: 1) providing fair compensation to injured persons; and 2) deterring similar negligent behaviors from reoccurring in the future. 60 in recent years, a growing number of scholars have come to the conclusion that, in the context of medical malpractice, the tort system is simply not designed to successfully achieve these goals.61 numerous empirical studies have shown that only a very small percentage of injured patients choose to file a claim, and there is a lack of evidence supporting the claim that the tort system actually deters negligent behaviors and improves overall healthcare quality.62 on the compensation side, michelle m. mello and david m. studdert argue that the current medical liability system “does not perform well either in compensating eligible patients or in avoiding claims by those who are not eligible.”63 the seminal harvard medical practice study (hmps), for example, found that “the fraction of medical negligence that leads to claims is probably under 2 percent.”64 also, “only about a sixth of the claims that were filed involved both negligence and a cognizable injury.”65 a similar conclusion was reached by another influential report that examined medical errors in the states of utah and colorado commonly known as the utah-colorado medical 60 see michelle m. mello & david m. studdert, the medical malpractice system: structure and performance, medical malpractice and the us health care system: new century, different issues, 15-23 (outlining a list of criteria for evaluating the performance of the medical liability system which includes compensation, deterrence, corrective justice, and efficiency; and then evaluating the performance of the current tort-based medical liability system against the four criteria outlined.). 61 id. 62 id. at 18. 63 id. at 17. 64 russell localio et al., relation between malpractice claims and adverse events due to negligence—results of the harvard medical practice study iii, 325 new eng. j. med. 245, 249 (1991). 65 mello & studdert, supra note 60, at 16. http://dx.doi.org/10.1056/nejm199107253250405 2015 rethinking the tort liability system and patient safety 345 practice study.66 it revealed that only 2.5% of those injured due to negligence actually chose to bring a claim.67 there are also troubling signs that courts may not have the ability to consistently distinguish meritorious from nonmeritorious claims. troyen brennan et al., found that “the severity of the patient’s disability, not the occurrence of an adverse event or an adverse event due to negligence, was predictive of payment to the plaintiff.”68 overall, empirical studies often show that a significant portion of meritorious claims is left uncompensated, whereas non-meritorious ones received unjustified payment.69 combining this with the fact that only a small percentage of eligible patients file claims, mello and studdert concluded that “the weight of the evidence points to a liability system that is deeply flawed in terms of its ability to direct compensation to its intended beneficiaries.”70 the low percentage of injured patients who actually file lawsuits compromises the other institutional goal of the tort liability system: deterrence. as mello and studdert pointed out, “[t]he overall picture that emerges from the existing studies of the relationship between malpractice claims experience and medical errors is that evidence of a 66 eric j. thomas et al., incidence and types of adverse events and negligent care in utah and colorado, 38 med. care 261 (2000). 67 david m. studdert et al., negligent care and malpractice claiming behavior in utah and colorado, 38 med. care 250 (2000). 68 troyen brennan et al., relation between negligent adverse events and the outcomes of medical-malpractice litigation, 335 new eng. j. med. 1963 (1996). 69 mello & studdert, supra note 60, at 17 (arguing that the current medical liability system “does not perform well either in compensating eligible patients or in avoiding claims by those who are not eligible.”). a similar study conducted by studdert and colleagues also showed that “only a small fraction of claims lacked documented injuries. however, approximately one third of claims were without merit in the sense that the alleged adverse outcomes were not attributable to error. claims without merit were generally resolved appropriately: only one in four resulted in payment. when close calls were excluded, claims without evidence of injury or error accounted for 13 percent of total litigation costs.” david m. studdert et al., claims, errors, and compensation payments in medical malpractice litigation, 354 new eng. j. med. 2024, 2029 (2006). 70 mello & studdert, supra note 60, at 17. http://dx.doi.org/10.1097/00005650-200003000-00002 http://dx.doi.org/10.1097/00005650-200003000-00003 http://dx.doi.org/10.1056/nejm199612263352606 http://dx.doi.org/10.1056/nejmsa054479 346 indiana health law review vol. 12:1 deterrent effect is (1) limited and (2) vulnerable to methodological criticism.”71 several factors may contribute to this phenomenon. first, the legal standard of care often looks unclear to physicians, which may confuse them about what they should do to avoid medical liability.72 second, the market of malpractice insurance is rarely experience-based, which limits the economic power of insurance premiums to alter physician behaviors. 73 in addition, only a small portion of the costs associated with medical errors are internalized by providers. instead, public and private medical insurers as well as patients absorb much of the burden.74 the lack of cost internalization further weakens the connection between tort liability and physicians’ behavioral change. b. discouraging systemic learning the second line of criticism that supports the conventional wisdom relates to the inability of the tort system to facilitate systemic learning. specifically, the tort system often contains hindsight bias75 and applies a narrow understanding of causation.76 hindsight bias is a human tendency to treat incidents that involve high risk and uncertainty at the time as destined to happen and easily avoidable.77 to err is human suggests that such biases may “mislead” a reviewer into simplifying the causes of an accident, highlighting a single element as the cause and overlooking multiple contributing factors.”78 as a system that retroactively assigns responsibility and liability to 71 id. at 19-20. 72 id. at 20. 73 id. 74 id. at 20-21. 75 to err is human, supra note 2, at 53-54 (referring to hindsight bias as “things that were not seen or understood at the time of the accident [which] seem obvious in retrospect”). 76 see sydney dekker, just culture: balancing safety and accountability 108-09 (2nd ed. 2012) (discussing how legal professionals narrow down related facts and stories to create truth relevant to legal claims). 77 to err is human, supra note 2, at 53-54 78 id. 2015 rethinking the tort liability system and patient safety 347 actions that already occurred, the tort liability system inevitably implies the risk of hindsight biases. such a risk, in turn, may help explain the questionable performance of the tort system to distinguish legitimate claims from illegitimate ones.79 another institutional weakness of the tort system that hinders systemic learning is its narrow understanding of causation. the causal relationship established in the courts is often focused on the direct or proximate connection between the visible, so-called sharp-end, error and the individual who committed that particular error. 80 this conceptualization of causation runs against the premise of the psm that visible errors often are just symptoms, rather than the root cause, of larger systemic problems. under such a narrow conceptualization, however, factors related to latent errors but unrelated to the particular legal claim may be seen as being irrelevant and out of the equation. both weaknesses reflect a deeper structural issue of the us adversarial system. in the adversarial system, information is treated as a weapon to win the litigation battle rather than a resource that, when shared, can help develop real solutions to real life problems.81 in order to win the battle of litigation, it is critical for each party to ensure that their opponent has as few weapons at their disposal as possible. sharing information, therefore, is inherently against the self-interest of both parties. a critical function of depositions, particularly those of expert witnesses, is hence to determine what information can and 79 studdert et al., supra note 69 . 80 medical malpractice cases follow the general rule of tort law that requires meeting four elements to establish negligence liability: duty, breach of duty, causation, and damages. richard a. epstein, cases and materials on torts 145-6 (10th ed. 2012). among these four elements, causation is further divided into causation in fact and proximate causation, and the latter is often interpreted by using the but-for rule, i.e., whether the damages would have happened ‘but for’ the alleged negligence. national medical consultants, p.c., medical malpractice: an overview, http://www.nationalmedicalconsultants.com/ (follow “resources” hyperlink; then follow “medical malpractice: an overview” hyperlink) (last visited april 19, 2015). 81 see studdert et al., supra note 2. 348 indiana health law review vol. 12:1 cannot be included as evidence. as a result, information being presented to the court inevitably becomes piecemeal, and the final decision on the question of fact has to be determined within the confines of this fragmented information.82 collectively, these structural weaknesses fuel medical professionals’ animosity against the tort liability system. medical professionals often have the impression that the legal system treats the medical profession unfairly and does not respect or is unwilling to understand the nuances of medical science. as a result, many providers, when encountering medical errors, passively rely on legal teams to manage their exposure to legal risk, or choose to keep total silence in the hope that the incident will eventually go away without triggering litigation. 83 these common strategies thus create a cultural barrier against openness and transparency, 84 commonly known as the code-ofsilence.85 the code-of-silence is not a new phenomenon. rather, it has been passed down from one generation of medical professionals to another via the implicit influence of both the medical school education and acculturation in the working environment. some describe this influence as the hidden curriculum, which refers to the phenomenon that new generations of medical professionals learn how to deal with medical errors by imitating their predecessors whose main, if not only, approach to these incidents is to not talk 82 see daniel shuman, expertise in law, medicine and healthcare, 26 j. health pol. pol’y & l. 267, 270 (2006) (noting that one critique of the adversary system is that “the information presented to the courts by privately retained experts is biased because attorneys seek out experts who will best assist their case and not necessarily because the experts represent mainstream science”). 83 see wei, supra note 5, at 16-34 (arguing that the medical community shares a culture of silence against not only disclosure to patients, but to colleagues and external error reporting systems). 84 see studdert et al., supra note 2. 85 see lucinda e. jesson & peter b. knapp, my lawyer told me to say i'm sorry: lawyers, doctors, and medical apologies, 35 wm. mitchell l. rev. 1410, 1413-18 (2009) (discussing the medical culture that follows the code of silence and the recent actions taken by actors in the healthcare system to change that culture). 2015 rethinking the tort liability system and patient safety 349 about them at all.86 today, the fear that admitting errors will bring significant legal, financial, professional, and emotional consequences remains very real.87 fair or not, this fear has continued to be cited as the main reason for the medical community’s resistance to many patient safety initiatives.88 iv. from conventional wisdom to learning from litigation since the beginning of the psm, the conventional wisdom that tort hinders the pursuit of patient safety has been widely embraced. 89 in recent years, however, an emerging body of literature has challenged this conventional view.90 the literature indicates a healthcare system where providers increasingly treat the litigation process as a useful source of information for various safety and quality improvement activities.91 this paper terms this nascent phenomenon as learning from litigation (lfl).92 the following section offers a brief description of the phenomenon by discussing: 1) examples of tort-facilitated learning activities; 2) the cultural change in healthcare organizations that underlies the emergence of learning from litigation; and 3) the campaign to promote disclosure 86 see nancy berlinger, after harm: medical error and the ethics of forgiveness 24-26 (2005) (arguing that each generation of medical students, by observing their predecessors, learn that the proper way to deal with mistakes is to keep them secret, a hidden curriculum which prevents them from sharing information with patients). 87 such a mentality is often the result of a medical culture that views physicians as experts that never make mistakes. physicians therefore often fear that admitting errors might lead to legal liability, financial burdens, and even endangerment of their careers. see lucian l. leape, error in medicine, 272 jama 1851, 1851-52 (1994) (criticizing the concept of infallibility that permeates the culture of medical practice and motivates physicians to be dishonest and cover up their mistakes). 88 see supra notes 2 and 5 and accompanying text. 89 to err is human, supra note 2, at 43; studdert el al., supra note 2, at 286. 90 schwartz, supra note 1, at 1239-43. 91 id. at 1246-51. 92 schwartz, supra note 10. http://dx.doi.org/10.1001/jama.1994.03520230061039 350 indiana health law review vol. 12:1 and apology, which is one of the driving forces behind this cultural change in healthcare organizations. a. how providers learn from litigation at the core of lfl is the growing awareness that the malpractice litigation process actually produces many byproducts that contain useful information for the purpose of safety and quality improvement. examples of these byproducts include: 1) potential claim files, i.e., documents prepared by risk management personnel in anticipation of potential litigation; 2) actual notices of claims and legal complaints that are filed by injured patients against the providers; 3) closed claim files, which typically are maintained by hospitals themselves or their liability insurance companies; and 4) litigation discovery, where expert witnesses are tasked with analyzing files and documents pertaining to the disputed incidents.93 these valuable sources of information in turn allow providers to engage in various systemic learning activities to identify weaknesses in their delivery systems. these analytical and learning activities, which produce specific knowledge on what went wrong and how to fix it, hold the key to materializing the potential of the tort liability system to improve patient safety. the following section explores three notable examples of these activities, including: 1) filling the gaps in error reporting systems; 2) identifying causes to individual adverse events and their solutions; and 3) turning individual claim data into broader datasets for statistical analysis to identify the hidden patterns and trends of preventable errors. 1. strengthening reporting systems the information collected through potential claims, actual claims, closed claims, and litigation discovery often exposes the gaps in error reporting systems. here, “gap” refers to the underreporting of incidents that are due to either flaws in the reporting system’s design or problems in 93 schwartz, supra note 1, at 1267-75. 2015 rethinking the tort liability system and patient safety 351 its implementation; malpractice claims help combat both in several ways. 94 first, malpractice claims help capture errors with delayed manifestation; that is, mistakes that cause injuries which develop overtime. most reporting systems are designed to capture errors that immediately or quickly lead to visible injuries. 95 errors with delayed manifestation, in particular those involving delayed diagnoses, missed diagnoses, and treatment errors, can often evade reporting systems.96 these errors are often disproportionately brought to healthcare organizations’ notice by legal claims.97 a recent study of brigham and women’s hospital, for instance, compared what the hospital learns from various data sources, 98 including error reporting systems, internal reports to risk management, walk arounds, patient complaints, and actual malpractice claims. 99 the study observed that 24.3% of actual malpractice claims contained allegations that physicians committed errors of clinical judgment, a category that covers various types of errors with delayed manifestation.100 in comparison, only 12.3% of patient complaints, 7.3% of risk management reports, and 1.1% of hospital’s incident reporting database contained such information.101 secondly, there is often poor coordination between hospitals’ internal reporting systems and other internal databases for patient complaints and occurrence reports, i.e., the reports commonly filed by nurses to risk managers to 94 id. at 1277-83. 95 id. at 1279. 96 id. at 1279-80. 97 id. at 1280-81. 98 see generally osnat levtzion-korach et al., integrating incident data from five reporting systems to assess patient safety: making sense of the elephant, 36 joint comm’n j. on quality & patient safety 402, 405-06 (2010) (discussing that each of the five reporting systems studied had its own patient safety issues, which lead to the conclusion that “hospitals should use a broad portfolio of approaches and then synthesize the messages from all individual approaches into a collated and cohesive whole”). 99 id. at 403-04. 100 id. at 405-06. 101 id. 352 indiana health law review vol. 12:1 notify the occurrence of unusual events, many of which involve injuries. 102 malpractice claims, therefore, often become the first time when hospitals learn of many errors that should have been brought to their attention through other internal channels. lori andrews, in her 2005 ethnographic study of how errors are discussed in hospitals, reported that only 13.49% of patients in the study who filed a lawsuit were documented in an occurrence report. 103 there is also a weak connection between hospitals’ reporting systems and other error-detecting mechanisms such as walk arounds and morbidity and mortality meetings. in her study, andrews further discovered that many errors discussed in walk arounds and morbidity and mortality meetings do not get forwarded to error reporting systems and hospital management.104 as a result of this disconnect, healthcare organizations, particularly larger ones with more layers of bureaucracy, must often rely on litigation claims to broaden their monitoring web of medical errors. 2. finding the root cause of individual incidents information obtained from litigation also allows healthcare organizations to unearth the real causes of specific events and develop solutions to address them. this particular learning activity can be done in various ways. for example, risk managers nowadays often review closed claims for safety lessons and action plans, and then forward obtained lessons to safety and quality departments for correction and improvement.105 also, it has increasingly become a common practice to feed information obtained during discovery back to healthcare organizations for potential safety lessons.106 in smaller hospitals, the feedback process may occur more quickly and smoothly since the same people and offices might oversee legal representation, claims management, as well as 102 lori andrews, studying medical error in situ: implications for malpractice law and policy, 54 depaul l. rev. 357, 368-69 (2005). 103 id. at 369. 104 id. at 367-68. 105 joanna schwartz, supra note 1, at 1272. 106 id. at 1270-72. 2015 rethinking the tort liability system and patient safety 353 safety and quality improvement. 107 in larger hospitals, however, people who actually participate in litigation need to develop ways to communicate the information back to the organization. 108 such a communication can be done informally between defense attorneys and risk managers.109 in some organizations, there are regular meetings where defense attorneys representing hospital personnel present what they learned in discovery.110 in addition, potential and actual claims often expose providers to events previously unknown.111 these events can then become the subject of internal error-reviewing mechanisms such as morbidity and mortality conferences, clinical peer review, and root cause analysis (rca), or be further reported to external reporting systems that include rca as part of standard procedure. among the various internal error-reviewing mechanisms, rca is often hailed by the psm as an effective way to turn errors into safety lessons.112 root cause analysis refers to a structured method to identify underlying latent factors that contribute to the occurrence of visible sharp-end errors. the agency for healthcare research policy (ahrq) describes the process of rca as follows: rcas should generally follow a prespecified protocol that begins with data collection and reconstruction of the event in question through record review and participant interviews. a multidisciplinary team should then analyze the sequence of events leading to the error, with the goals of identifying how the event occurred (through identification of active errors) and why the event occurred (through systematic identification and analysis of latent errors).113 107 id. at 1270. 108 id. 109 id. at 1271. 110 id. 111 see discussion supra part iv.a. 112 see agency for healthcare research and quality, patient safety primers: root cause analysis, (2014). 113 id. 354 indiana health law review vol. 12:1 root cause analyses can be initiated by healthcare organizations themselves, or be triggered by external error reporting systems. for example, the joint commission’s sentinel event reporting system requires reporting facilities to submit rca reports and develop action plans.114 some state-run and nationwide systems include a similar requirement. 115 systems run by many patient safety organizations (psos), on the other hand, may conduct root cause analysis for the reporting facilities and provide them with safety improvement recommendations.116 many psos later also aggregate rca reports, which are analyses of individual events, into larger databases to facilitate another type of litigation-facilitated learning activities: the identification of the patterns and trends of preventable errors.117 3. identifying the patterns and trends of errors another way for providers to utilize the information collected through litigation is to identify the patterns and trends of medical errors. there are multiple ways to produce this information. one common practice is to review the aggregated pool of notices of claims and legal complaints to search for troublesome trends. 118 a dose of reality 114 id. although the decision to report to the sers is voluntary, in situations where the joint commission discovers the existence of sentinel events, the organization is still required to provide a rca report as well as an action plan. if, after review, the analysis and plan are viewed as unacceptable, the organization may be placed on the watch list regarding its accreditation status until an acceptable plan is submitted. 115 see generally editorial staff, a national survey of medical error reporting laws, 9 yale j. health pol’y l. & ethics 201, 218 (2008) (reporting the result of a national survey conducted to catalogue the statutes and regulations related to error reporting systems in each of the twenty-seven states). 116 see center for assessment of radiological sciences, patient safety work product (pswp), radiotherapy incident reporting & analysis system, http://carspso.org/patient_safety_work_product.aspx (last visited feb. 20, 2015). 117 agency for healthcare research and quality, supra note 112. 118 schwartz, supra note 1, at 1269. 2015 rethinking the tort liability system and patient safety 355 reported that eighty-six percent of respondents replied that they either often or sometimes review trends across notices of claims and legal complaints to acquire performance and safety lessons.119 another productive method to extract useful information from malpractice claims is to analyze closed claims. files of closed claims may include data and records prepared and maintained by attorneys, hospitals, and liability insurers.120 this paper refers to such examinations as closed claims analyses (ccas). a dose of reality reported seventy-six percent of respondents either often or sometimes review closed claims for safety and quality improvement purposes.121 a dose of reality also reported that closed claims are commonly used for educational and training purposes.122 individual providers can conduct ccas in collaboration with their malpractice insurers. in certain specialties, ccas are being done at a large scale via collaborations between professional organizations, malpractice insurers, and volunteer physicians. 123 the most successful attempt to conduct a large scale cca has been within the specialty of anesthesiology. the inception of this effort can be traced back to 1984, when the anesthesia closed claims project (accp) was put into practice. 124 the accp is a multidisciplinary project aimed at “identify[ing] safety concerns in anesthesia, patterns of injury, and develop[ing] 119 id. 120 id. at 1272. 121 id. 122 id. at 1272-73. 123 see generally frederick w. cheney et al., standard of care and anesthesia liability, 261 jama 1599 (1989) (examining and evaluating the experience of the american society of anesthesiologists in studying closed malpractice claims in order to learn from mistakes and reduce anesthesia-related injuries). 124 frederick w. cheney, the american society of anesthesiologists closed claims project: what have we learned, how has it affected practice, and how will it affect practice in the future?, 91 anesthesiology 552, 552 (1999); see also anesthesia closed claims project, welcome to the anesthesia closed claims project and its registries, http://depts.washington.edu/asaccp/ (last visited feb. 20, 2015). http://dx.doi.org/10.1001/jama.1989.03420110075027 http://dx.doi.org/10.1097/00000542-199908000-00030 356 indiana health law review vol. 12:1 strategies for prevention in order to improve patient safety.”125 the beginning of the accp coincided with a period of time when anesthesiology was widely considered to have the highest liability risk among specialties. liability insurance premiums skyrocketed as a result, which motivated stakeholders in anesthesia to get behind the accp initiative. the idea was that once the overall practice of anesthesia become safer, the legal and financial risk would correspondingly drop due to fewer incidents.126 the accp functions by trained anesthesiologists reviewing and ultimately turning closed claim files provided by malpractice insurance companies into standardized summaries.127 currently, the project has more than 10,000 claims for events from 1970-2012. there are twenty to twenty-five reviewers who spend fifty to sixty days annually reviewing claim files. twenty-one insurance companies, insuring approximately 13,000 anesthesiologists, currently participate.128 the data collected is then turned into detailed case summaries that become available for research, particularly in the area of statistical analysis. information contained in these standardized summaries may include “patient information, surgical procedure and positioning, anesthetic evaluation and technique, events leading to the injury or claim, type and severity of injury, outcome of litigation, and 125 anesthesia closed claims project, supra note 124. 126 see cheney, supra note 124, at 552 (suggesting that the perception that reducing errors will lead to lower litigation risk is the motivation behind the accp project); karen l. posner, closed claims project shows safety evolution, anesthesia patient safety found., available at http://www.apsf.org/newsletters/html/2001/fall/02closedclaims.htm (last visited feb. 20, 2015) (stating that the motivation behind the project was the awareness that “[i]f anesthesia became safer and patient injuries were reduced, malpractice premiums should follow suit.”). 127 anesthesia closed claims project, anesthesia closed claims project, http://depts.washington.edu/asaccp/projects/anesthesia-closedclaims-project (last visited feb. 20, 2015). 128 anesthesia quality institute, http://www.aqihq.org/ closedclaims.aspx (last visited feb. 20, 2015). 2015 rethinking the tort liability system and patient safety 357 physician evaluations of potential for prevention and appropriateness of anesthesia care.”129 due to the fact that most minor incidents claims are resolved early without in-depth investigation, files of these incidents tend to lack detailed information. the accp database therefore has a strong bias toward severe injuries.130 the bias is consistent with the nature of the current tort system. due to the high financial cost to file a lawsuit, claims involving severe injuries are more likely to progress further into litigation due to the higher probability of obtaining a large jury award to justify the investment.131 the bias toward severe injuries has both positive and negative implications. on the negative side, this bias means that other means are necessary to capture safety concerns associated with less severe injuries. 132 on the positive side, however, the severe injury bias also allows researchers to tackle issues with serious consequence first.133 severe incidents typically occur very rarely and are unfit for statistical study. by compiling data of individual events into a larger database, the accp allows researchers to apply statistical methodology to the studies of these incidents.134 the results of the accp have been presented at meetings and conferences, and distributed via publications of the american society of anesthesiologists (asa). since 1984, the project has produced fifty peer-reviewed journal publications, seventy asa newsletter articles, and numerous presentations and training sessions. 135 these studies have helped the anesthesiology specialty to identify weaknesses in anesthesia practice, as well as the changing profile of anesthesia liability.136 over the years, anesthesia 129 anesthesia closed claims project, projects, http://depts.washington.edu/asaccp/projects (last visited aug. 20, 2014). 130 posner, supra note 126. 131 id. 132 id. 133 id. 134 id. 135 anesthesia closed claims project, supra note 124. 136 see posner, supra note 126. for more journal articles and newsletters on the closed claims project, see anesthesia closed 358 indiana health law review vol. 12:1 mortality rates have dropped from two deaths every 10,000 anesthetics administered to around one death every 200,000–300,000 anesthetics administered, an achievement noted in to err is human as an example for other members of the healthcare system to follow.137 b. the changing culture of healthcare organizations ultimately, the trend toward broader utilization of information obtained from tort litigation is supported by gradual but fundamental changes in hospitals’ organizational culture. in a dose of reality, joanna schwartz outlined three major changes: 1) changing selfperception of risk managers; 2) growing transparency within hospitals; and 3) increasing transparency with patients and their families.138 risk managers are positions traditionally held by lawyers. they report to the general counsel, and have long viewed themselves as responsible only for handling legal risks.139 influenced by the patient safety movement, the self-perception of risk managers has changed. today, risk managers increasingly view their work as being connected with the broader effort to improve safety and quality.140 this changing perception coincides with the overall shift of healthcare organizations’ attitudes toward transparency.141 claims project, supra note 124 (follow “publications” hyperlink; then follow “closed claims project overview” hyperlink). meghan f. macrae, however, cautions that it is important to recognize that malpractice claims as a sample do not reflect the actual composition of medical errors. it is therefore necessary not to overstate the effect of closed claims analysis in calculating risks and predicting trends in anesthesia errors. cf. generally, meghan f. macrae, closed claims studies in anesthesia: literature review and implications for practice, 75 am. ass’n nurse anesthetists j. 267 (2007), available at http://www.aana.com/newsandjournal/documents/macraep267-275.pdf (last visited apr. 19, 2015). 137 to err is human, supra note 2, at 144-45. 138 see schwartz, supra note 1, at 1251-66. 139 id. at 1261. 140 id. at 1251-66. 141 id. at 1254-66. 2015 rethinking the tort liability system and patient safety 359 joanna schwartz indicated that a high percentage of the risk managers she interviewed were receptive to the ideal of transparency. 142 this growing receptiveness to transparency applies to disclosures to patients and information-sharing within healthcare organizations.143 in particular, there is increasing communication and collaboration between risk management and safety and quality improvement personnel.144 the sentiment remains strong even in states with weaker apology law protections.145 such a change echoes the broader shift in the role played by legal professionals in healthcare organizations. in the past, the role of legal professionals in healthcare organizations was viewed simply as setting boundaries for physicians as to what legally can and cannot be done, even when such things may be convenient or effective from a medical or managerial perspective. in an era when healthcare has become one of the most highly regulated industries, lawyers have increasingly been relied upon to offer strategic advice related to the direction of the organization’s future development.146 142 id. at 1254-55. 143 id. at 1254-66. the increasing transparency with patients coincides with the growing interest in the communication-andresolution programs (crp) in the healthcare industry. for the historical background and current status of crp programs, see discussion infra part iv(c). 144 typically it is physicians and nurses who serve as safety/quality improvement personnel. while risk managers often report to the office of general council, safety/quality personnel often report to the medical department, or in some cases to offices specifically designated to monitor safety/quality related efforts. 145 see schwartz, supra note 1, at 1260. 146 see louise g. trubek et al., transformations in health law practice: the intersections of changes in healthcare and legal workplaces, 12 ind. health l. rev. __ (2015) (describing the changing landscape post-aca for health law practice, in which health lawyers, including both those practice in-house or in corporate law firms, are increasingly relied upon to deal with quality improvement, regulatory compliance, and strategic planning issues, and assume greater involvement in shaping the direction of healthcare organizations’ development). 360 indiana health law review vol. 12:1 the shifting role of legal professionals in healthcare organizations adds an additional dimension to the debate over the relationship between tort and patient safety. with the changing perception of their role, legal professionals today are playing an active role in encouraging healthcare organizations to learn from litigation by using information gathered from lawsuits to improve patient safety. in serving such a function, legal professionals may help gradually alleviate the strong animosity between trial lawyers and patients on one hand and the medical community on the other. moreover, these legal professionals may also help to transform the aforementioned litigation-induced learning activities into standardized policy packages that can be applied more broadly, or even allow them to be institutionalized as legal or regulatory policies. c. disclosure, apology, and communication-and-resolution one of the driving forces behind the changing medical culture, in which providers increasingly embrace the value of tort litigation for patient safety, is the campaign to promote full disclosure and apology in medical dispute resolution, which began to gain popularity in the early 2000s.147 the campaign has been a multi-prong effort. in 2001, for example, the joint commission added a requirement to disclose adverse outcomes to patients to their accreditation process. 148 also, in the past decade, scholars, policymakers, and non-profit organizations (most famously the sorry works! coalition) have continued to promote the idea of “apology laws.”149 apology laws are statutes that shield disclosed information and apologetic or 147 see schwartz, supra note 1, at 1256-58 (citing the growing awareness of the benefits of disclosure and apology as one of the major reasons for the trend toward transparency with patients). 148 id. at 1255-56; doug wojcieszak et al., the sorry works! coalition: making the case for full disclosure, 32 joint comm’n j. on quality & patient safety 344, 344 (2006) (discussing the new accreditation requirement). 149 sorry works!, http://sorryworkssite.bondwaresite.com (last visited feb. 20, 2015). 2015 rethinking the tort liability system and patient safety 361 sympathetic remarks made by medical professionals following the incidence of adverse events from being used as evidence against the medical professional in any later litigation. 150 today, thirty-six states provide such protections to various degrees.151 by offering these legal protections, it is hoped that medical professionals will become more inclined to disclose their mistakes, offer sympathy, and apologize when necessary.152 against the broader backdrop of the campaign to promote full disclosure and apology, one specific initiative has stood out as the most promising and has garnered increasing attention: communication-and-resolution programs (crp). in addition to the crp, other labels such as disclosure-and-offer or early settlement programs are also commonly used to describe these initiatives.153 the crp typically refers to a comprehensive claims management model pioneered by the university of michigan health system (umhs).154 in 2001, the umhs 150 sorry works!, apology laws, http://sorryworkssite. bondwaresite.com/apology-laws-cms-143 (last visited feb. 20, 2015). 151 id. 152 cf. william m. sage et al., how policy makers can smooth the way for communication-and-resolution progress, 33 health aff. 11, 14 (2014) (stating that apology laws “seem more important to the adoption of new crps than to the operation of existing ones”). 153 see generally, michelle m. mello et al., communication-andresolution programs: the challenges and lessons learned from six early adopters, 33 health aff. 20 (2014) [hereinafter lessons learned from six early adopters] (discussing communication-and-resolution programs); michelle m. mello et al., implementing hospital-based communication-and-resolution programs: lessons learned in new york city, 33 health aff. 30 (2014) [hereinafter lessons learned in new york city] (discussing communication-and-resolution programs); allen kachalia & michelle m. mello, new directions in medical liability reform, 364 new. eng. j. med. 1564, 1569 (2011) (referring to four demonstration projects funded by the agency for healthcare research and quality “testing expansions of the disclosure-and-offer approach championed by the university of michigan health system”); kevin sack, doctors start to say ‘i’m sorry’ long before ‘see you in court’, n.y. times, may 18, 2008, at 1 (discussing the positive impact of a disclosure and apology policy adopted by the university of illinois medical center in 2006). 154 health system: university of michigan, http://www.uofmhealth.org/ (last visited feb. 20, 2015); see also, mike http://dx.doi.org/10.1056/nejmhpr1012821 362 indiana health law review vol. 12:1 launched a new dispute resolution model, which consisted of four basic elements: 1) immediate disclosure of harm; 2) timely expression of sympathy and apology; 3) commitment to investigation and prevention efforts to identify and address the root cause of the incident; and 4) a quick offer of compensation if investigation demonstrates potential negligence.155 by bundling the four elements, the crp constitutes a unique and increasingly popular approach to implementing full disclosure and apology. the uniqueness comes in at least two fronts: first, the crp is predicated on the willingness of health systems to make a quick offer of compensation when negligence is involved.156 second, by including investigation and prevention efforts in the package, the crp has the potential to encourage providers to incorporate systemic learning into the medical dispute resolution process. 157 the commitment to the crp mitka, disclosing medical errors does not mean greater liability costs, new study finds, 304 jama 1656, 1657 (2010) (discussing the disclosure policy of the umhs, under which “the institution admits fault and offers compensation when an internal investigation uncovers medical error”); hillary r. clinton & barack obama, making patient safety the centerpiece of medical liability reform, 354 new eng. j. med. 2205, 2207 (2006) (citing the reduced time and money spent on resolving malpractice claims under the umhs model). another often cited pioneer of this type of policy is the veteran affairs hospital in lexington, kentucky. for discussion on the va story, see e.g., steve s. kraman & ginny hamm, risk management: extreme honesty may be the best policy, 131 annals intern. med. 963, 964 (1999); jennifer k. robbennolt, apologies and medical error, 467 clin. orthop. relat. res. 376, 380 (2009). 155 health system: university of michigan, supra note 154. 156 this element is often the most difficult for providers to embrace. see, lessons learned in new york city, supra note 153, at 35 (2014) (evaluating the performance of a new york state demonstration project funded by the federal agency for healthcare quality and research to implement the umhs model and reporting that, while participants improve their commitment to internal investigation of adverse events and external communication with patients, most participants are reluctant to make quick compensation in fear that, among other things, doing so may actually increase their liability exposure). 157 the emphasis, if properly implemented, has the potential to move hospital culture towards transparency and self-learning. id. at 34 (citing increasing communication with patients and better tracking of http://dx.doi.org/10.1001/jama.2010.1422 http://dx.doi.org/10.1056/nejmp068100 http://dx.doi.org/10.7326/0003-4819-131-12-199912210-00010 http://dx.doi.org/10.1007/s11999-008-0580-1 2015 rethinking the tort liability system and patient safety 363 approach is often supported by the awareness that early resolution, without disputes developing into legal claims, is the future of medical malpractice reform. 158 early resolution, in turn, can best be achieved when providers are committed to honest investigation, sincere apology, and information transparency. to a certain extent, the uniqueness of the crp limits its application. whereas most hospitals today have disclosure policies in place as required by the joint commission, the implementation of such policies varies significantly from organization to organization and there are only a small number of hospitals that fully implement all four elements of the crp.159 in particular, many healthcare organizations are quite hesitant to make early settlement offers, unless adverse events as areas of success in the new york state demonstration project). 158 the author interviewed a risk management director of a large urban wisconsin hospital that employs a disclosure policy similar to the michigan model. when asked about whether the hospital has policies similar the crps in place, the director replied: “we do have a disclosure policy. we expect any sentinel event to be fully disclosed to the patient and family and the medical record documentation to include the relevant facts of the discussion. our malpractice climate is so different from chicago or michigan, but if we have a situation where we have clear liability, we work with the family. we won’t make them hire an attorney but let them know that it is certainly their right to do so if they choose. we feel very strongly that disclosure and early resolution is best practice.” when asked about when the shift toward early resolution started taking place, the director responded that “i would say over the past five to seven years more healthcare organizations have adopted the philosophy that early disclosure and apology is the way to go.” interview with risk management director, large urban wisconsin hospital (august 20, 2014). 159 in addition to the umhs and the va-lexington, other so-called “early adopters” of policies akin to the umhs model include the stanford university medical indemnity and trust insurance company (sumit) and the university of illinois medical center at chicago (uimcc). see generally lessons learned from six early adopters, supra note 153; kachalia & mello, supra note 153 (discussing that in 2010, the federal agency for healthcare quality and research funded a series of state demonstration projects to “test[] expansions of the disclosure-and-offer approach championed by the university of michigan health system.”). 364 indiana health law review vol. 12:1 they are in situations where there is nothing to lose.160 hospitals often fear that making early offers may actually heighten their exposure to litigation and monetary compensation.161 another common fear is that early offers may not be welcomed by liability insurance companies, many of which prefer the providers to take a strong and adversarial stance against claimants.162 therefore, early offers in these scenarios may lead to conflicts between the insurer and the insured.163 despite its limited application, the impressive financial benefits of the umhs policy quickly turned the crp into an attractive policy option that psm activists are eager to apply elsewhere. in the five years after the implementation of its claims management model, the umhs observed a sharp decrease in the cost and frequency of litigation.164 specifically, the annual expenses on litigation reduced from three million dollars to one million dollars, while the number of malpractice claims dropped by more than half.165 thus, it is no surprise that the basic framework of the crp was later repeated in various health policy proposals. the 2005 white paper of the joint commission on the accreditation of healthcare organizations (jcaho), for example, envisioned that a well-functioning liability system would include the following components: (1) prompt disclosure of errors; (2) apology when necessary; (3) preventive efforts; (4) early compensation; and (5) 160 lessons learned in new york city, supra note 153, at 35 (discussing the dynamic between providers and their insurance companies that may lead providers to be hesitant in making settlement offers); see also, interview with risk management director, large urban wisconsin hospital (august 20, 2014) (acknowledging that “sometimes insurance companies would drive [provider] posture”). in certain situations, admitting errors may even void the contract with the insurance company. 161 lessons learned in new york city, supra note 153, at 35 (“hospitals, insurers, and surgeons all reportedly worried that early settlement offers might heighten their liability exposure”). 162 id. 163 id. 164 thomas h. gallagher et al., disclosing harmful medical errors to patients, 356 n. engl. j. med. 2713, 2716 (2007) 165 id. http://dx.doi.org/10.1056/nejmra070568 2015 rethinking the tort liability system and patient safety 365 alternative dispute resolution mechanisms that resolves the dispute in a swift and fair manner.166 the umhs story further inspired legislative efforts at the federal level to make the crp national policy. in 2006, then united states senator for illinois, barack obama teamed up with hillary clinton, then united states senator for new york, to introduce a bill titled the national medical error disclosure and compensation (medic) act.167 the bill specifically referred to the umhs experience as its inspiration. its main provisions provided financial incentives and legal protections to encourage doctors, hospitals, and health systems to participate in the medic program, which essentially replicates the umhs model.168 the medic bill eventually failed to pass in congress in 2006. president obama’s election in 2008, however, injected new energy into the effort at the national level to promote the crp. heeding the call of president obama in a speech delivered before a joint session of congress in the fall of 2009, the federal agency for healthcare research and quality (ahrq) in 2010 awarded seven state demonstration projects to develop alternatives to the current tort liability system.169 among the seven state demonstration projects, five incorporated elements of the crp.170 an important function of these ahrq projects is to provide research opportunities to examine whether the implementation of the crp can help create a better culture of safety and encourage providers to learn from errors and litigation; with preliminary evidence showing positive signs. as one of the seven demonstration projects funded by ahrq in 2010, the new york state (nys) project included a cooperative agreement with a research team led by michelle mello of the harvard law school to evaluate the 166 william m. sage, malpractice reform as a health policy problem, in medical malpractice and the u.s. health care system 41-42 (william m. sage & rogan kersh eds., 2006). 167 s. 1784, 109th cong. (2005) 168 clinton & obama, supra note 154, at 2206. 169 agency for healthcare research and quality, medical liability reform and patient safety initiative progress report 3-7, archived at http://perma.cc/733p-f8a9. 170 id. 366 indiana health law review vol. 12:1 performance of the project. 171 the evaluation was conducted by, among other methods, interviewing key participants, and the result was published in health affairs in early 2014.172 the article reported that, among the four crp components, participating hospitals underachieved in their commitment to making early settlement offers.173 also, the article identified several areas for improvement for future implementation of the crp, such as leadership support, physician buy-in, and more financial and personnel resources.174 the overall experience of the project, however, displayed that the crp can help change the culture of participating hospitals in the following ways. first, participating hospitals show better communication with patients. 175 more importantly, the experience of implementing the crp often pushes risk managers and safety/quality personnel to track and monitor adverse events more thoroughly and systemically. resources and procedures such as additional staff, electronic systems, and regular meetings are being added to review and follow adverse incidents. 176 these efforts may lead to better coordination of various players involved in the dispute resolution process, and a more streamlined investigation process.177 171 grant proposal, new york state medical liability reform and patient safety model 15-20, archived at http://perma.cc/d2phl3fl. for the results of this research collaboration, see harvard school of public health, http://www.hsph.harvard.edu/michellemello/ (last visited mar. 28, 2015). 172 harvard school of public health, supra note 170; william m. sage et al., supra note 152; lessons learned from six early adopters, supra note 153; lessons learned in new york city, supra note 153. 173 lessons learned in new york city, supra note 153 at 35. 174 id. at 35-37 (citing the necessity to obtain physician and leadership support as critical lessons learned from the nys project). 175 id. at 34-35 (citing improved communication with patients and between clinicians and risk management as two areas of success of the nys project). 176 id. (reporting that participating hospitals in the nys project see improved tracking of events, which allow timely communication with patient and more rigorous analysis of potential problems). 177 id. (arguing that “hospitals’ improvements in disclosure, reporting, and follow-up are important elements of ‘enabling’ a climate and culture of patient safety,” in which “clinicians felt they could speak 2015 rethinking the tort liability system and patient safety 367 v. tort reform in the age of learning from litigation: early resolution via communication-and-resolution programs as a foundation for the future the emerging phenomenon of lfl sheds new light on the tort reform debate. it is increasingly clear that conventional wisdom does not capture the full reality.178 today, healthcare organizations have the capacity and choice to respond to the external pressure of tort liability by decreasing error rates and improving performance. such improvement, in turn, can be achieved by engaging in systemic learning activities outlined in the previous section, with many providers having already chosen to commit to these activities. 179 the commitment to these learning activities holds the key to unlocking the previously underdeveloped potential in tort law to deter future mistakes.180 therefore, any serious tort reform proposal aiming to promote patient safety should focus on systemically connecting the dispute resolution process with these analytical and learning activities. a major question that remains is how this goal can be achieved in a sustainable fashion. despite the fact that medical malpractice reform is one of the most politically sensitive subjects, the answer to this question seems surprisingly simple. in the era of psm and lfl, there is a growing recognition that the best approach to reforming the tort litigation system is actually to encourage early resolution via the crp to prevent disputes from ever openly about adverse events, and it bolstered a shared perception of the value of the safetyenhancing practices of disclosure and reporting”) (footnotes omitted). 178 what it does is reflect a popular sentiment among medical professionals that the liability system is a game rigged against them. the sentiment, provable or not, remains strong and prevalent today, and needs to be understood and empathized when having serious health policy debates. 179 this development seems to support hyman and silver’s argument that tort law can actually help make a business case for quality to providers by adding the cost of preventable errors into hospitals’ financial consideration. see hyman & silver, supra note 1, at 957-63. 180 supra note 60. 368 indiana health law review vol. 12:1 evolving into legal claims.181 the crp, along with closed claims analysis projects such as the anesthesia closed claims project, are two patient safety initiatives that have proven to be both productive and cost-efficient in turning medical disputes into patient safety lessons. 182 unlike traditional tort reform proposals that focus on controlling the severity and frequency of claims,183 initiatives like the crp more directly aim to control the severity and frequency of errors. 184 specifically, as mentioned above, the implementation of the crp often pushes providers to reform their internal adverse events investigation processes, hence creating a better safety culture and working environment that enables providers to more effectively learn from mistakes and past litigation.185 in addition to the patient safety potential, the crp also has two notable strengths compared to other tort reform proposals. the first strength is that the crp is often less politically sensitive than other proposals. the implementation of the crp, which is essentially a dispute resolution policy at the individual organizational level, typically requires minimal legislative action.186 the limited 181 supra note 158. 182 supra note 137 and gallagher et al. supra note 165. 183 supra note 49. 184 see generally richard c. boothman et al., a better approach to medical malpractice claims? the university of michigan experience, 2 j. health & life sci. l. 125 (2009) (arguing that the michigan model, which emphasizes honesty and transparency, is superior to the traditional approach in that it attacks the underlying driver of medical malpractice). cf. michael d. greenberg et al., rand institute for civil justice, is better patient safety associated with less malpractice activity? evidence from california 15 (2010), available at http://www.rand.org/pubs/technical_reports/tr824.html (last visited mar. 28, 2015) (investigating, by using administrative data and measures, the relationship between patient safety outcome and malpractice claims filed against hospitals in california, and suggesting that “county-level safety performance in california . . . is significantly associated with changes in the volume of malpractice claims occurring in the same counties during the same years”). 185 see supra part iv.c. 186 the nys project, for example, was initially a response to an earlier failed attempt to enact tort reform in 2009 in the state. michelle m. mello et al., implementing hospital-based communication-and2015 rethinking the tort liability system and patient safety 369 legislative involvement not only makes it easier to initiate a crp experiment and accumulate practical experience, but also shields the crp away from unnecessary partisan politics. 187 in addition, the crp also yields significant financial benefits for providers and patients. in the current tort litigation system, very few claimants, typically only those with severe injuries, can obtain compensation via litigation. 188 encouraging providers to reach early settlement with patients may broaden the pool of patients able to receive fair compensation. this is achieved by allowing those with lesser means or those only modestly injured to also receive monetary payment or other types of support. together, these comparative strengths make the crp a solid foundation for tort reform in the era of lfl. the ahrq, for example, has signaled its intention to disseminate the crp to the whole nation.189 despite these potential benefits, broader pursuit of early resolution will face at least two challenges. first, there are various institutional barriers that must be overcome to increase providers’ receptiveness toward the idea of early resolution via the crp. second, it is simply unrealistic to expect that the crp can capture all medical disputes. it is thus critical to contemplate how the tort litigation process can be reformed in ways that facilitate, rather than discourage, the efforts to promote early resolution. in this last section, the paper discusses these two challenges. in particular, the paper argues that there are two different approaches to reforming the litigation process that are consistent with the broader ideal of patient safety. the first is to change the structure of the tort litigation system to (1) reward providers’ effort to pursue patient safety; and (2) reduce the cost of litigation discovery. the second is to incorporate crp ideas into the litigation process, in resolution programs: lessons learned in new york city, supra note 153, at 31. 187 id. 188 see discussion supra part iii.a. 189 lessons learned in new york city, supra note 153, at 37 (“ahrq has signaled interest in moving toward nationwide dissemination of the crp approach”). 370 indiana health law review vol. 12:1 particular during the pre-trial settlement negotiation stage. specifically, such a goal can be achieved by applying ideas such as collaborative law and judge-directed negotiation to the process.190 a. overcoming barriers against early resolution although individual providers can decide to follow the example of the umhs and pursue the crp at their own initiative, large-scale implementation of these programs still requires government involvement to help overcome numerous institutional obstacles. examples of these barriers include: (1) malpractice reporting requirements, (2) the structure of liability insurance, and (3) the contingency fee system. in addition to overcoming these barriers, policies such as apology laws and pre-suit notification laws also have the potential to ease the resistance against early resolution. apology laws play an important role in building physicians’ confidence in adopting new crps,191 while presuit notification laws provide a cooling-off period in which alternative methods of dispute resolution such as the crp may be employed. 192 physicians often cite the legal requirement to report any settlement payment to the national practice data base and state licensing boards as a major hurdle that affects their willingness to settle.193 the fear is that such records will affect their reputation and career development. some providers are looking for ways to circumvent these requirements. for example, settlement payments can be made under the name of the healthcare organization instead of individual physician. also, in some cases compensation can take the form of a fee waiver or care support in order to avoid being reported.194 in the long run, 190 see discussion infra part v.c. 191 supra note 152. 192 sage et al., supra note 152, at 13 (discussing that pre-suit notification laws “create cooling-off periods intended to give both parties time to resolve their dispute in other ways, and . . . can help maintain the spirit of cooperation needed for crps to operate well”). 193 id. at 16. 194 id. 2015 rethinking the tort liability system and patient safety 371 however, it will likely be necessary to enact policies to allow settlement payments reached through procedures such as the crp to be exempt from these reporting requirements. the second obstacle involves the role of liability insurers. the support of medical malpractice liability insurers is critical to successfully implementing the crp. in the case of the umhs, an academic hospital, the umhs directly employs its physicians as university faculty and provides them liability coverage by a captive insurance company of the healthcare organization.195 the hospital thus has more leeway in using its insurance coverage as an incentive to encourage physicians’ to embrace the culture of transparency. 196 in hospitals that have different employment structures, however, there may be multiple liability insurers involved in the same dispute. 197 each insurer may have different financial arrangements with the insured, and their interests may conflict with other insurers or even with the provider whose liability they are supposed to cover.198 this factor adds another layer of complexity to the already delicate dynamic of settlement negotiations.199 195 mitka, supra note 154, at 1657 (mentioning that the medical staff at umhs “comprises faculty members employed by the university of michigan medical school; the system and its employees have professional liability coverage provided by an established captive insurance company”). 196 lessons learned from six early adopters, supra note 153, at 26 (suggesting that having a captive insurer is an advantage in implementing crps, as such arrangements yield hospitals “a relatively high degree of control over their hospital’s medical staff, since the same institution both employed and provided medical malpractice liability insurance to these physicians.”). 197 id. at 27 (suggesting that “in cases involving multiple insurers, each insurer may seek to shift financial responsibility to others” and “may have different philosophies about settlement”). 198 for example, several participating hospitals in the nys project have the same organization, offering both risk and claim management and liability insurance. participants in crps in these hospitals reported that they were reluctant to make early settlement offers in fear that doing so would run against the interests of this outside risk management organization. see lessons learned in new york city, supra note 153, at 35; see also supra note 160. 199 id. 372 indiana health law review vol. 12:1 finally, the contingency fee system may also spell trouble for early settlements. it should be reasonable to surmise that, in some situations, plaintiff attorneys may be disinterested in negotiating early settlement under the contingency fee system. this is either because the amount of compensation is usually significantly smaller than what may otherwise be obtained in adjudication, or due to the patient’s unwillingness to pay a significant portion of the settlement for legal representation since the offer is already on the table and less legal work is involved.200 to encourage more trial lawyers to pursue early settlement would require the participation of attorneys who are willing to charge hourly fees.201 such a change may also open the door for experimenting with collaborative law practices in the area of medical malpractice.202 b. reforming the tort litigation system despite the various benefits of early resolution, the crp will not resolve all disputes. eventually, many disputes will fail to reach early resolution and enter litigation, and it is often these remaining disputes that are the most costly and tough on the parties. reforming the litigation process itself will continue to be a critical part of the tort reform discussion. the existing tort reform proposals often focus on controlling the input (i.e., access to justice) and output (i.e., amount of compensation) of the litigation process.203 often 200 sage et al., supra note 152, at 15; lessons learned in new york city, supra note 153, at 38. 201 sage et al., supra note 152, at 15; lessons learned in new york city, supra note 153, at 38. in particular, sage et al. referred to the ahrq project in washington state where the possibility for a system of hourly legal representation has been examined by an official task force comprised of patient advocates, attorneys, and risk management experts. 202 collaborative law attorneys typically work on hourly fees. 203 many suggest that these reforms, in particular damages caps, can help produce a malpractice environment more favorable to crps by lowering the fear and financial burden of litigation on providers. cf. sage et al., supra note 152, at 12-13 (pointing out that crps can and have been successfully implemented in states without damage caps). 2015 rethinking the tort liability system and patient safety 373 overlooked by these proposals, however, are two issues that may have an even greater potential to change the relationship between tort and patient safety. these issues are: (1) how to reward providers’ efforts to pursue patient safety; and (2) how to reduce the cost of acquiring information. since the beginning of the movement, psm activists have long searched for realistic ways to channel the pressure of tort liability to incentivize the pursuit of patient safety. there are three potential approaches to achieve this goal. the first is to adopt the widely embraced yet rarely implemented proposal of enterprise liability.204 the second is the idea of a safety bonus, that is, to reward providers with good safety track records by modifying the standard of care or reducing the amount of compensation. in the poor state of health care quality, for example, hyman and silver advocated the use of limitations on non-economic damages as carrots to encourage providers to improve error reporting and error reduction. 205 another widely discussed proposal to incentivize the pursuit of patient safety is the idea of using evidence-based medicine, often in the form of clinical practice guidelines (cpgs),206 as either evidence to establish a standard of care or defense against liability.207 the idea behind the proposal 204 enterprise liability is part of the second wave tort reform efforts. supra note 49; see lawrence o. gostin & peter jacobson, law and the health system 460-61 (2006) (discusses literature on the proposal of enterprise liability); see also kinney, supra note 49, at 101-10; studdert et al., supra note 2, at 287-90 (details enterprise liability within the context of different waves of tort reform). 205 hyman & silver, supra note 1, at 985-87. 206 institute of medicine, guidelines for clinical practice: directions for a new program 8 (marilyn j. field & kathleen n. lohr eds., 1990) (defining cpgs as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”). 207 hyman & silver, supra note 1, at 990 (arguing for the use of evidence-based medicine as an absolute against legal liability). in actual legal practice, cpgs have been used in courts by plaintiffs and defendants for both exculpatory and inculpatory purposes. see, mello, supra note 28, at 648, 666-67. the inculpatory use typically involves plaintiffs introducing cpgs as evidence to establish the 374 indiana health law review vol. 12:1 is that, since cpgs are produced using up-to-date scientific research, having medical practices adhere to these behavioral guidelines should improve the overall quality of healthcare delivery. however, the past experiences of using the cpgs as a legal defense have failed to live up to that promise. 208 critics often attribute the failure to the inconsistency of the quality of the cpgs, as well as the vagueness of their language.209 the vagueness of the cpgs standard of care. id. at 677-94. the exculpatory use, on the other hand, often relates to so-called safe-harbor legislation, which are state statutes designed to allow physicians to apply cpgs as affirmative defenses, but block a plaintiff ’s rights to use similar guidelines as support for their claims. id. at 695-707. overall, michelle mello criticized both exculpatory and inculpatory uses of cpgs, as cpgs are often too vague to yield a definite answer and are untrustworthy due to the numerous and unregulated sources of these guidelines. see generally michelle m. mello, of swords and shields, the role of clinical practice guidelines in medical malpractice litigation, 149 u. pa. l. rev. 645 (2001) (suggesting that “the best course of action, at least at this point in time, is to restrict their use by both plaintiffs and defendants”). 208 see generally swords and shields, supra note 207. 209 id. a 2011 institute of medicine report also concluded that, although it is encouraging that there is significant advancement in this field, the cpgs still “suffer from shortcomings in the guideline development process, often compounding limitations inherent in their scientific evidentiary bases.” to address these concerns, the report recommended reforming the process of cpg generation to alleviate the concern over conflicts of interest and make these guidelines more credible to medical professionals. institute of medicine, clinical practice guidelines we can trust 2 (2011). see also barry furrow et al., health care reform supplement materials 78-79 (2012) (discussing the continuing legal debate over the trustworthiness of cpgs). in addition, one of the pioneers of the cpg movement, dr. david eddy, cautions that medical science might have entered the terrain of individualized cpgs based on human genome technology. as a result, the traditional population-based cpgs, which can only offer broad instructions because they have to apply to a broad population, might no longer represent the best possible care. david m. eddy et al., individualized guidelines: the potential for increasing quality and reducing costs, 154 med. & pub. issues 627, 633 (2011) (arguing that the availability of more personalized genomic data enables the development of “a new generation of guidelines that are more clinically realistic and that may deliver higher quality at lower cost than has been possible in the past”). http://dx.doi.org/10.2307/3312867 2015 rethinking the tort liability system and patient safety 375 reduces their usefulness in the courts, as legal answers often demand a clear degree of certainty. for the proposal to serve a meaningful function, the process of generating the cpgs will need to be reevaluated and improved, which is an issue that has also been addressed by the aca.210 the second often-overlooked issue involves the cost of obtaining information in the litigation process. a major contributor to the costliness of tort litigation is the expense of acquiring expert testimony. the contingency fee system, however, only allows trial lawyers to recoup these sunken costs after winning a case. these factors thus generate a strong bias toward cases with serious injury, as these cases have the potential for greater amounts of compensation which justify these risky investments. changing the cost structure of tort litigation by reducing the cost of expert testimony has the potential, at least theoretically, to alter lawyers’ attitudes toward tort litigation in at least two ways. first, trial lawyers may be more willing to take less serious cases if the investment becomes smaller, which may help broaden the pool of patients with access to compensation. second, lawyers may be less insistent on obtaining adjudication and more receptive to earlier and smaller settlements, which opens the door for broader adoption of the crp or even collaborative law practice. this paper argues that there are two possible ways to reduce the cost of acquiring expert testimony. the first is the broader involvement of judges, possibly through assigning their own experts, in assessing the validity of evidence. this proposal is consistent with the famous supreme court case daubert v. merrell dow pharmaceuticals,211 in which the court noted that “[f]aced with a proffer of expert scientific testimony . . . the trial judge must determine at the outset . . . whether the expert 210 for example, section 10303(c) of the aca requires the secretary of the department of health and human services to identify existing and new clinical practice guidelines. the patient protection and affordable care act of 2010, public law 111–148, § 6301, 124 stat. 119, 728, 42 u.s.c. § 1320e(c). it remains uncertain, however, how much impact this provision can have on the quality and trustworthy of cpgs. 211 daubert v. merrell dow pharms., 509 u.s. 579 (1993). 376 indiana health law review vol. 12:1 is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue.” 212 such a duty in turn requires the trial judge to conduct “a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.”213 specifically, the assessment should include consideration of testability, peer review and publication, and known or potential error rates of the scientific knowledge or technique.214 most trial judges, however, have generally not followed the daubert test. 215 a common explanation for this reluctance is that american judges typically have profound faith in both the competence of the jury system and the democratic values represented by such a system. 216 american judges, therefore, have been generally very reluctant to tinker with parties’ access to evidence unless under extreme circumstances. 217 a possible, and maybe only feasible, alternative is for the medical community and trial lawyers bar associations to work together. the idea is to create a system to identify experts that can be trusted by both sides. the availability of this information may indirectly reduce the cost of discovery by limiting the number of experts that are needed for both sides to prove their cases. 212 id. at 592. 213 id. at 592-93. 214 id. at 593-94. 215 see generally daniel shuman, expertise in law, medicine and healthcare, 26 j. health pol. pol’y & l. 267 (2001) (discussing the factors behind trial judges and lawyers’ resistance to the principles laid out in daubert). 216 id. at 271. 217 for example, the use of judge-appointed experts has been very rare. id. at 270. 2015 rethinking the tort liability system and patient safety 377 c. incorporating crp ideas into the pre-trial settlement process this paper further argues that, in situations where disputes fail to reach early resolution and enter litigation, the four components of the crp (i.e., disclosure, apology, investigation, and quick offer) can be incorporated and replicated in the litigation process to make the process more conducive for the pursuit of patient safety. this goal can be achieved by applying different approaches to settlement negotiations that occur after the lawsuits are filed. examples of these approaches include collaborative law and judge-directed negotiation (jdn). collaborative law refers to a growing style of practice in family law.218 the approach uses the settlement process as a venue to pool resources together and develop solutions that better fit the family situation. collaborative law attorneys work with the other side with the shared goal of reaching a settlement agreement.219 outside experts, such as psychologists and social workers, are often brought in to provide professional help. 220 if a settlement cannot be reached, these attorneys are forbidden by signed agreement to take the case to trial; which is a key feature of the collaborative law practice.221 this paper suggests that the same style of practice can be applied to the area of medical malpractice. by attorneys 218 pauline tesler is often credited as pioneering the collaborative law practice. see generally pauline h. tesler, collaborative law: achieving effective resolution in divorce without litigation (2nd ed. 2008) (offering a comprehensive introduction to the collaborative model, including the necessary skill sets, proper mentality, documents and forms, and other legal issues); see, e.g., william h. schwab, collaborative lawyering: a closer look at an emerging practice, 4 pepp. disp. resol. l. j. 351 (2004); james k. l. lawrence, collaborative lawyering: a new development in conflict resolution, 17 ohio st. j. on disp. resol. 431 (2002); john lande, possibilities for collaborative law: ethics and practice of lawyer disqualification and process control in a new model of lawyering, 64 ohio st. l. j. 1315 (2003). 219 tesler, supra note 218. 220 id. 221 id. 378 indiana health law review vol. 12:1 concentrating on reaching settlement agreement and promising not to bring the dispute to trial, a space for dialogue can be created where both sides can have an open and less confrontational conversation. ideally, providers during this process should follow the principles of crp; that is, they should be transparent about their records and investigation results, and a settlement offer should be made if negligence is discovered by the investigation. outside experts trusted by both parties can also be brought in to analyze the evidence and allow claimants to assess the prospect of their case. there are, of course, significant barriers to transplanting the collaborative law approach from family law to medical malpractice. for example, people may fear that the lack of trust and relationship between defense and plaintiff attorneys in this area of law makes the cooperation between them enormously difficult. also, collaborative law attorneys typically charge hourly fees, and there will be an issue of whether trial lawyers in medical malpractice cases would be interested in this kind of payment system. these obstacles will need to be sufficiently addressed before attorneys on both sides can seriously consider the possibility of engaging in collaborative law practice. another possible approach that is already being experimented with is the jdn approach. judge directed negotiation refers to a program pioneered by bronx county, new york judge douglas mckeon. 222 since its implementation, the program has been credited with producing speedier resolutions and lower costs for malpractice disputes in the experimental regime.223 as a result, the program was later incorporated into the demonstration project of the nys project, which expanded 222 new york state medical liability reform and patient safety model, supra note 171, at 5. 223 id. (stating that the number of open claims where the jdn was initially being experimented dropped from 1400 in the year 2003 to slightly over 1000 in the year 2009. the program also achieved savings of up to $50 million every year in costs associated with medical malpractice disputes resolution.). 2015 rethinking the tort liability system and patient safety 379 jdn to manhattan, brooklyn, and later erie county, where buffalo is located.224 in the nys project, the jdn program is implemented to catch claims that cannot be resolved through the crp, which the project calls the disclosure and early settlement program. 225 the jdn program features, among other things, specially trained judges to guide parties all the way through the settlement negotiation process. 226 these designated judges are assisted by a medical advisor/program coordinator, who are often registered nurses, and their main duty is to coordinate and moderate regular meetings between attorneys and the parties themselves.227 these meetings typically begin early in the litigation process before the plaintiff’s attorney develops a strong commitment, both financially and otherwise, to the case.228 the program also encourages the designated judge, to the extent it does not violate the parties’ trust, to share his or her preliminary assessment on the case, so as to allow litigants to evaluate the realistic prospect of their case.229 since its launch, both the plaintiff and defense bar associations have endorsed the program.230 the main goal of the jdn program is to facilitate early resolution of disputes, not to encourage systemic learning. the participation of the medical advisor/program coordinator, however, has great potential on that front. these registered nurses are familiar with how healthcare organizations handle mistakes and claims. with proper training, they have the potential to serve the role of outside coordinators who observe or even nudge providers to thoroughly investigate the event and properly communicate 224 id.; see also medical liability reform and patient safety initiative progress report, supra note 169, at 6. 225 new york state medical liability reform and patient safety model, supra note 171, at 7-14. 226 id. at 12. 227 id. 228 id. 229 id. at 13. 230 new york state shows benefits of crp demonstration project, bulletin of the american college of surgeons, archived at http://perma.cc/99ka-47w5. 380 indiana health law review vol. 12:1 with patients. in addition, having specifically trained judges allows them to become repeat players in medical malpractice cases. 231 such experience may give them greater awareness of the psm ideas and allow them to play the role of a champion and advocate for patient safety. vi. conclusion this paper examined the changing landscape of the debate over the relationship between tort law and patient safety. in doing so, the paper explains that in recent years there has been a growing trend among providers to utilize claim and litigation data as opportunities to improve the performance of the delivery system, a trend referred to by this paper as the phenomenon of learning from litigation. by exploring this phenomenon, in particular how healthcare providers actually turn malpractice litigation into safety lessons; this paper argues that the best approach to tort reform in the age of learning from litigation is to encourage early resolution via communication-andresolution programs. this approach not only has financial benefits in the form of reduced claims and payouts from providers and an expanded pool of patients eligible for compensation, but also yields patient safety benefits by shaping a more transparent and safer medical culture. the proposed approach, in turn, can be supported by policies that reward providers’ commitment to patient safety; reduce the cost of discovery; and help overcome the cultural, legal, and economical barriers against early resolution. the proposed reform approach that focuses on early resolution can be further supported by encouraging another relatively easy, cheap, and uncontroversial patient safety initiative: closed claims analyses. due to its focus on claims that have already been resolved, rather than open claims that are still being litigated, ccas are rarely treated as a serious tort reform proposal. the successful experience of the anesthesia closed claims project, 232 however, shows 231 new york state medical liability reform and patient safety model, supra note 171, at 13. 232 see discussion infra part 4.a. 2015 rethinking the tort liability system and patient safety 381 that ccas may actually have great potential to indirectly alleviate the malpractice crisis by making medical practice safer without having to substantially alter the existing legal framework of tort law. also, similar to the crp, ccas do not require prior legislative authorization, and can be conducted by healthcare organizations on their own initiative. eventually, the pursuit of early resolution of medical disputes via the crp demands a new type of attorney, that is, one that views each case as a problem to solve rather than adversarial battles to win. these “new lawyers” must also be willing to work with the other side to develop solutions if necessary, and must be open to a different type of payment mechanism such as an hourly charge.233 in addition, there are also legally trained individuals working within healthcare organizations, such as in-house counsel and risk managers, who play instrumental roles in turning litigation data into safety improvement lessons. the collaboration between these legal professionals, as well as with other types of professionals in healthcare organizations, plays a critical role in making learning from litigation possible. 233 this demand echoes the gradual emergence, highlighted by julie macfarlane, of an alternative conception of advocacy referred to by macfarlane as ‘conflict resolution advocacy.’ the new lawyer, macfarlane argued, “will conceive of her advocacy role more deeply and broadly than simply fighting on her client’s behalf. this role comprehends both a different relationship with the client—closer to a working partnership . . . and a different orientation toward conflict.” conflict resolution advocacy, therefore, means “working with clients to anticipate, raise, strategize, and negotiate over conflict and, if possible, to implement jointly agreed outcomes.” see julie macfarlane, the new lawyer: how settlement is transforming the practice of law 109 (2008). works of eleanor d. kinney susan david demaine* eleanor d. kinney was a prolific scholar throughout her thirty-five years as a professor at indiana university robert h. mckinney school of law. she authored or co-authored more than seventy-five journal articles, publishing in numerous peer-reviewed medical and health journals, as well as law reviews. she wrote three books, edited a fourth, and published nine book chapters. professor kinney’s work has been cited in at least ten court opinions. her work has garnered more than 700 citations in law review articles, and nearly 200 in medical and health policy journals. the influence of her work places her within the top 1,000 most cited legal scholars.1 although a scholar of many aspects of health care law, professor kinney’s work on medicare and medicaid was particularly influential. her 1990 report to the administrative conference of the united states, reprinted in the ohio state law journal under the title rule and policy making for the medicaid program: a challenge to federalism, helped establish her national reputation as an expert in the field. just over a decade later, her guide to medicare coverage decision-making and appeals, became an essential tool for those practicing in administrative health law. after her retirement, she continued to publish in this area, with additional books appearing in 2015 and 2017. professor kinney also developed an interest in health law at the international level when the idea of an “international human right to health” attracted notice. several of her most cited articles address this right, and she went on to write about related subjects such as global responses to health crises, comparisons between various national constitutions’ provisions regarding health and health care, and the differences in laws regarding information for consumers. she also wrote about the development of international administrative law more generally. medical malpractice and its reform were other areas of interest and influence for professor kinney. over the course of her career, she published more than a dozen articles and book chapters in this area, and her 2002 book protecting american health care consumers added a discussion of medical malpractice concerns to the conversation, ongoing at the time, about patient protection and reforms in policymaking. in protecting american health care consumers, she also looked closely at procedural reform and uninsured health care consumers, describing the impending crisis as a “thunderhead on the horizon.” prior to professor kinney’s work, patient protection discussions largely ignored the uninsured. not * associate director, ruth lilly law library, and lecturer in law, indiana university robert h. mckinney school of law. j.d. 1999, university of kentucky; m.s.l.s. 1995, university of kentucky. 1. according to heinonline’s author report, prof. kinney ranks 964 for “cited by articles,” 729 for “cited by articles (past 10 years),” 248 for “cited by articles (previous year +ytd)”, and 254 for “cited by cases.” all of these numbers reflect only those citations appearing in heinonline’s databases, which include most law reviews but not many journals in other fields such as health policy or medical ethics. as a result, her rankings may be artificially somewhat low. 10 indiana health law review [vol. 17:9 surprisingly, when the affordable care act (aca) was passed in 2010 to address the crisis and make insurance available to everyone, professor kinney’s scholarship kept up with the changes; although retired as a faculty member, she published the affordable care act and medicare in comparative context with cambridge university press as well as multiple law review articles on the aca. her last article, published in 2018, was written in response to the 21st century cures act of 2016. her interest in health law and her productivity simply never flagged. the following bibliography is a nearly exhaustive list of professor kinney’s publications, excluding only the many short updates (a few paragraphs each) she wrote for the american hospital association’s health law vigil newsletter when she worked in the aha’s office of legal and regulatory affairs in the early 1980s. publications books eleanor d. kinney, protecting american health care consumers (duke university press, 2002). aba section of antitrust law, guide to medicare coverage decisionmaking and appeals (eleanor d. kinney, eds., 2002). eleanor d. kinney, administrative law of health care in a nutshell (west academic, 2017). eleanor d. kinney, the affordable care act and medicare in comparative context (cambridge university press, 2015). articles in peer-reviewed medical ethics and health policy journals jason t. eberl, eleanor d. kinney, & matthew j. williams, foundation for a natural right to health care, 36 j. med. & phil. 537 (2011). lance gable, brooke courtney, robert gatter, & eleanor d. kinney, global public health legal responses to h1n1, 39 j.l. med. & ethics 46 (2011). heather a. mccabe & eleanor d. kinney, medical legal partnerships: a key strategy for addressing social determinants of health, 25 j. gen. internal med., supp. 2 s200 (2010). eleanor d. kinney, realization of the international human right to health in an economically integrated north america, 37 j.l. med. & ethics 807 (2009). 2020] works of eleanor d. kinney 11 ulla connor, miguel f. ruiz-garrido, william rozycki, elizabeth goering, eleanor d. kinney & julia m. koehler, patient-directed medicine labeling: text differences between the united states and spain, 5 comm. & med. 117 (2008). eleanor d. kinney, the corporate transformation of medical specialty care: the exemplary case of neonatology, 36 j.l. med. & ethics 790 (2008). eleanor d. kinney, the origins and promise of medical standards of care, 6 virtual mentor 574 (2004). eleanor d. kinney, an empirical and critical look at the current medical liability crisis, 20 frontiers health serv. mgmt. 31 (2003). eleanor d. kinney, john kennedy, cynthia a. loveland cook, jay a. freedman, kathleen a. lane & siu l. hui, a randomized trial of two quality improvement strategies implemented in a statewide public community based, long-term care program. 41 med. care 1048 (2003). eleanor d. kinney, administrative law and the public’s health, 30 j.l. med. & ethics 212 (2002). eleanor d. kinney, the brave new world of medical standards of care, 29 j.l. med. & ethics 323 (2001). tom l. beauchamp, bruce jennings, eleanor d. kinney & robert j. levine, pharmaceutical research involving the homeless, 27 j. med. & phil. 547 (2002). nancy l. swigonski, eleanor d. kinney, deborah a. freund & thomas kniesner, unfinished business: inadequate health coverage for privately insured seriously ill children, 30 child. health care 219 (2001). kevin t. stroupe, eleanor d. kinney & thomas kniesner, chronic illness and health insurance-related job lock, 20 j. pol’y analysis & mgmt. 525 (2001). kevin t. stroupe, eleanor d. kinney & thomas kniesner, does chronic illness affect the adequacy of health insurance coverage? 25 j. health pol. pol’y & l. 309 (2000). eleanor d. kinney, ming tai-seale, james y. greene, rilla murray & william tierney, three political realities in expanding coverage for the working poor: one state’s experience, 18 health aff. 188 (1999). eleanor d. kinney, deborah a. freund, mary elizabeth camp, karen a. jordan & marion christopher mayfield, serious illness and private health coverage: a unique problem calling for unique solutions 25 j.l. med. & ethics 190 (1997). 12 indiana health law review [vol. 17:9 eleanor d. kinney, tom robison, jay a freedman & cynthia a. loveland cook, automating assessment for community-based, long-term care: indiana’s experience, 21 generations 62 (1997). jay a. freedman, cynthia a. loveland cook, tom robison & eleanor d. kinney, collaborative quality improvement in community-based, long-term care, 21 joint commission j. on quality improvement 701 (1995). eleanor d. kinney, malpractice reform in the 1990s: past disappointments, future success? 20 j. health pol. pol’y & l. 99 (1995). william p. gronfein & eleanor d. kinney, bringing the patient back in: the rhetoric of victimization and medical malpractice, 6 persp. on soc. probs. 47 (1994). eleanor d. kinney & suzanne k. steinmetz, notes from the insurance underground: how the chronically ill cope, 19 j. health pol’y pol. & l. 633 (1994). charles m. clark & eleanor d. kinney, the potential role of diabetes guidelines in the reduction of medical injury and medical malpractice claims involving diabetes, 17 diabetes care 155 (1994). charles m. clark & eleanor d. kinney, standards for the care of diabetes: origins, uses and implications for third-party payment, 15 diabetes care supp. 1 10 (march 1992). william p. gronfein & eleanor d. kinney, controlling large medical malpractice claims: the unexpected impact of damage caps, 16 j. health pol. pol’y & l. 441 (1991). eleanor d. kinney & bob lefkowitz, capital cost reimbursement to community hospitals under federal health insurance programs, 7 j. health pol. pol’y & l. 648 (1982). law review articles eleanor d. kinney, 21st century cures act and medical device regulation departure from principles or catching the wave, 44 am. j.l. & med. 269 (2018). eleanor d. kinney, the accidental administrative law of the medicare program, 15 yale j. health pol’y l. & ethics 111 (2015). 2020] works of eleanor d. kinney 13 eleanor d. kinney, the affordable care act and the medicare program: the engines of true health reform, 13 yale j. health pol’y l. & ethics 253 (2013). eleanor d. kinney, the potential of captive medical liability insurance carriers and damage caps for malpractice reform, 46 new eng. l. rev. 489 (2012). eleanor d. kinney, prospects for comparative effectiveness research under federal health reform, 21 annals health l. 79 (2012). eleanor d. kinney, the real truth about death panels: comparative effectiveness research and the health reform legislation, 36 okla. city l. rev. 667 (2011). eleanor d. kinney, comparative effectiveness research under the patient protection and affordable care act: can new bottles accommodate old wine?, 37 am. j.l. & med. 522 (2011). eleanor d. kinney, administrative law protections in coverage expansions for consumers under health reform, 7 j. health & biomed. l. 33 (2011). eleanor d. kinney, realizing the international human right to health for noncitizens in the united states, 1 notre dame j. int’l comp. & human rts. l. 94 (2011). eleanor d. kinney, realizing the international human right to health: the challenge of for-profit health care, 113 w. va. l. rev. 49 (2010). eleanor d. kinney, for-profit enterprise in health care: can it contribute to health reform?, 36 am. j.l. & med. 405 (2010). eleanor d. kinney, heather a. mccabe, amy lewis gilbert, & janna jo shishler, altered standards of care for health care providers in the pandemic influenza, 6 ind. health l. rev. 1 (2009). eleanor d. kinney, health care financing and delivery in the us, mexico and canada: finding and establishing intentional principles for sound integration, 26 wis. int’l l.j. 934 (2009). eleanor d. kinney, hospital peer review of physicians: does statutory immunity increase risk of unwarranted professional injury? 13 mich. st. u.j. med. & l. 57 (2009). eleanor d. kinney & william m. sage, dances with elephants: administrative resolution of medical injury claims by medicare beneficiaries, 5 ind. health l. rev. 1 (2008). 14 indiana health law review [vol. 17:9 eleanor d. kinney, recognition of the international human right to health and health care in the united states, 60 rutgers l. rev. 335 (2008). eleanor d. kinney, can the medicare, medicaid and schip programs meet the challenges of public health emergencies, 58 admin. l. rev. 559 (2006). eleanor d. kinney & william m. sage, resolving medical malpractice claims in the medicare program: can it be done? 12 u. conn. j. ins. l. 77 (2006). eleanor d. kinney, administrative law approaches to medical malpractice reform, 49 st. louis u.l.j. 45 (2005). eleanor d. kinney & brian alexander clark, provisions for health and health care in the constitutions of the countries of the world, 37 cornell int’l l. rev. 285 (2004). eleanor d. kinney, the new medicare coverage decision-making and appeal procedures: can process meet the challenge of new medical technology?, 60 wash.& lee l. rev. 1461 (2003). eleanor d. kinney, the emerging field of international administrative law: its content and potential, 54 admin. l. rev. 1139 (2002). eleanor d. kinney, the international human right to health: what does it mean for our nation and world, 34 ind. l. rev. 1457 (2001). eleanor d. kinney, tapping and resolving consumer concerns about health care, 26 am. j.l. & med. 335 (2000). eleanor d. kinney, clearing the way for an effective federal-state partnership in health reform, 32 mich. j.l. reform 899 (1999). jana k. strain & eleanor d. kinney, the road paved with good intentions: problems and potential for employer-sponsored health insurance under erisa, 31 loy. u. chi. l. rev. 29 (1999). eleanor d. kinney, introduction (symposium: the independent counsel statute), 51 admin. l. rev. 627 (1999). eleanor d. kinney, behind the veil where the action is: private policy making and american health care, 50 admin. l. rev. 145 (1999). eleanor d. kinney, indiana’s medical malpractice reform revisited: a limited constitutional challenge, 31 ind. l. rev. 1043 (1998). 2020] works of eleanor d. kinney 15 eleanor d. kinney & myra c. selby, history and jurisprudence of the patientphysician relation in indiana, 30 ind. l. rev. 263 (1996). eleanor d. kinney, procedural protections for patients in capitated health plans, 22 am. j.l. & med. 301 (1996). eleanor d. kinney, medicare managed care from the beneficiary’s perspective, 24 seton hall l. rev. 101 (1996). eleanor d. kinney, resolving consumer grievances in a managed care environment, 6 health matrix 147 (1996). eleanor d. kinney, lisa clark copp, & marcia gonzales, the merits of state action antitrust immunity to promote hospital collaboration: a good idea for indiana?, 28 ind. l. rev. 1169 (1995). eleanor d. kinney, rule and policy making under health reform, 47 admin. l. rev. 403 (1995). eleanor d. kinney, protecting consumers and providers under health reform: an overview of the major administrative law issues, 5 health matrix: j. l. med. 83 (1995). eleanor d. kinney, jay a. freedman & cynthia a. loveland cook, quality improvement in community-based, long-term care: theory and reality, 20 am. j.l. & med. 59 (1994). eleanor d. kinney, private accreditation as a substitute for direct government regulation in public health insurance programs: when is it appropriate?, 57 l. & contemp. probs. 47 (1994). vaneeta m. kumar & eleanor d. kinney, indiana lawmakers face national health policy issues, 25 ind. l. rev. 1271 (1992). eleanor d. kinney, the role of judicial review in medicare and medicaid program policy: past experience and future expectations, 35 st. louis u.l.j. 759 (1991). eleanor d. kinney & william p. gronfein, indiana’s malpractice system: no fault by accident?, 54 l. & contemp. probs. 169 (1991). eleanor d. kinney, william p. gronfein, & thomas p. gannon, indiana’s medical malpractice act: results of a three year study, 24 ind. l. rev. 1275 (1991). eleanor d. kinney, legal and ethical issues in mental health care delivery: does corporate form make a difference?, 28 hous. l. rev. 175 (1991). 16 indiana health law review [vol. 17:9 eleanor d. kinney, rule and policy-making for the medicaid program: a challenge to federalism, 51 ohio st. l.j. 855 (1990) (republication of report prepared by request of the administrative conference of the united states, nov. 1990). eleanor d. kinney, in search of bureaucratic justice in the medicare program: adjudicating medicare home health benefits in the 1980s, 42 admin. l. rev. 251 (1990). eleanor d. kinney, setting limits: a realistic assignment for the medicare program? 33 st. louis u.l.j. 631 (1989). eleanor d. kinney & marilyn m. wilder, medical standard setting in the current malpractice environment: problems and possibilities, 22 u.c. davis l. rev. 421 (1989). eleanor d. kinney, national coverage policy under the medicare program: problems and proposals for change, 32 st. louis u.l.j. 869 (1988). eleanor d. kinney, the medicare appeals system for coverage and payment disputes: achieving fairness in a time of constraint, 1 admin. l.j. 1 (1987). eleanor d. kinney, coordinating rate setting and planning in states with mandatory hospital rate regulation: what makes a difference? 8 j. legal med. 397 (1987). eleanor d. kinney, making hard choices under the medicare prospective payment system: one administrative model for allocating medical resources under a government health insurance program, 19 ind. l. rev. 1151 (1986). eleanor d. kinney, medicare payment to hospitals for a return on capital: the influence of federal budget policy on judicial decision-making, 11 j. contemp. l. 453 (1985). eleanor d. kinney, comment, “the know your customer” rule of the nyse: liability of broker-dealers under the ucc and federal securities laws, 1973 duke l.j. 489. articles in foreign journals eleanor d. kinney, derecho administrativo de los ee.uu.: desafíos para los estados con las nuevas responsabilidades del derecho administrativo, 22 revista argentina del régimen de la administración pública 9 (2000). 2020] works of eleanor d. kinney 17 eleanor d. kinney, análisis crítico de los sistemas de salud en los ee.uu. y en la argentina: lecciones para su reforma, 6 aportes para la integracion latinamericana 67 (2000). book chapters eleanor d. kinney, heather a. mccabe, & r. hall, hays v. sebelius, in top 20 food and drug cases, 2009 & cases to watch (john reiss, ed., food & drug law institute, 2010). eleanor d. kinney, the international human right to health in domestic constitutional and statutory law, in law and ethics in rationing access to care in a high-cost global economy (wendy k. mariner & paula lobato de faria, eds., luso-american foundation, 2008). william m. sage & eleanor d. kinney, a malpractice system for medicare, in medical malpractice reform in the united states: new century, different issues (william m. sage & rogan kersh, eds., cambridge university press, 2006). eleanor d. kinney, medicare beneficiary appeals, in guide to medicare coverage decision-making and appeals (eleanor d. kinney, ed., american bar ass’n, 2002). eleanor d. kinney, a case study of indiana, in medicaid and state budgets: an overview of five states’ experiences in 2001 (kaiser comm’n on medicaid & the uninsured 2002). eleanor d. kinney, administrative law issues in professional regulation, in regulation of the healthcare professions (t. jost, ed., health admin. press 1997). eleanor d. kinney, medical practice guidelines: evolutionary trends and future implications, in health care delivery and tort: systems on a collision course? (e. rolph, ed., rand inst. for civ. just. 1991). eleanor d. kinney & bob lefkowitz, chapter ii: legislative history, and chapter viii: implications for hospitals, in health planning: lessons for the future (b. lefkowitz, ed., aspen 1983). robert c. maynard & eleanor d. kinney, the statute of limitations in medical malpractice law, in defense of medical malpractice cases (d. hirsch, ed., defense research institute, inc. 1977). 18 indiana health law review [vol. 17:9 book reviews eleanor d. kinney, health care choices: private contracts as instruments of health reform by clark c. havighurst, 17 j. legal med. 331 (1996). eleanor d. kinney, murders and madness: medicine, law and society in the fin de siècle by ruth harris, 14 legal stud. f. 435 (1990). miscellaneous publications heather a. mccabe & eleanor d. kinney, health care funding, in the child: an encyclopedic companion (richard a. shweder, ed., u. chicago press 2009). eleanor d. kinney, administrative law: proposing reforms to administrative procedure act, nat’l l.j., aug. 1, 2005, at s3. eleanor d. kinney, changes in the adjudication of medicare beneficiary appeals in the new medicare prescription drug legislation: reform or retreat?, 29 admin. & reg. l. news 6 (2004). eleanor d. kinney, would a single payer system provide universal health coverage in the united states?, l. & bioethics rep. 5 (2003). eleanor d. kinney, congress enacts sweeping changes in medicare procedures, 26 admin. & reg. l. news 7 (2001). eleanor d. kinney, consumer grievance and appeal procedures in managed care plans, 10 health law. 17 (1998). eleanor d. kinney, health insurance coverage in indiana: is there a problem, 1 in-roads 8 (1996). eleanor d. kinney, new standards for the standard of care, legal times, nov. 18, 1991, at supp. 29. eleanor d. kinney, elderly health care: for many, insurance an empty promise, legal times, jul. 25, 1988, at 16. same article in other papers: medicare, is it fulfilling its promise? the recorder, aug. 1, 1988, at 6; shedding light on medicare: decisions on coverage need more input from public, fulton cty. daily rep., jul. 27, 1988, at 2; government must stop making rules on medicare coverage behind closed doors, manhattan l., aug. 2-8, 1988, at 14. 2020] works of eleanor d. kinney 19 eleanor d. kinney, better safe than sorry: federal antitrust laws have a major impact on payment, efficiency, and expansion activities, 1 multies (1983). eleanor d. kinney, federal policy on hospital capital investment: review and outlook, 55 hospitals 75 (1981). extending the fantasy in the supermarket: where unhealthy food promotions meet children and how the government can intervene jennifer l. pomeranz, id, mph* i. introduction ...................................................................................... 118 ii. theretailenvironment ................................................................. 119 a. background and definitions ................................................... 119 b. food promotions directed at children .................................. 121 c. industry self regulatory pledges and nutritional quality of food promoted to youth .......................................................... 123 ill. research on effectiveness of child-targeted promotions .126 a. in-store promotions ................................................................ l27 b. packaging and packaging promotions ................................... i31 i. licensed characters and company spokescharacters ....... 132 2. other package promotion techniques ............................... 135 c. summary ................................................................................. 137 iv. regulating in-store and package promotions to protect children .................................................................................................. 137 a. government's role in the protection of children .................. 139 b. regulating the food retail environment ................................ l44 v. food and beverage packaging ..................................................... 145 a. central hudson overview ....................................................... 146 b. government restrictions on the use of characters on products ....................................................................................... 152 1. characters are deceptive and misleading under prong one of central hudson ............................................................ 152 2. refuting industry responses ............................................... 157 3. character restrictions should pass the central hudson test ........................................................................................... 159 c. other package restrictions .................................................... 164 vi. regulation of in-store promotions and placement .............. 166 a. in-store advertising restrictions ............................................ 166 b. in-store regulations ofconduct ............................................. 168 i. non-expressive and expressive conduct ............................ 168 2. other standards to regulate conduct ................................ 173 c. constitutional analysis of the in-store regulations ............... 175 1. regulating product location based on nutritional criteria ............................................ ......................................... 175 2. regulating product location based on nutritional • director of legal initiatives at rudd center for food policy & obesity, yale; mph, 2006, harvard school of public health; j.d., 2000, cornell law school. 118 indiana health law review [vol. 9:1 criteria and character use ................................................. .... 177 a. analysis under 0 'brien .................................................. 179 b. o'brien inquiry continued .............................................. 184 vii. conclusion ..................................................................................... 185 i. introduction the first exposure to the marketplace for most children comes as soon as they become a passenger in a shopping car at the grocery store.1 alt­ hough they do not yet know it, they are being marketed to by the food and beverage industry through packages, promotions, and displays surrounding them during this shopping experience. the marketing of unhealthful foods to children is a significant contributor to the epidemic of childhood obesity.2 the ftc found that in 2006, food and beverage companies expended $195 million, second only to the amount spent on television advertising, on pack­ aging and in-store displays targeted to children and adolescents. since then marketing within retail establishments has grown rapidly. almost all of the products marketed to children in retail establishments are for food of low nutritional value and tend to be high in salt, sugar, or fat.3 industry self­ regulatory pledges do not apply to this environment, and researchers have recently begun to systematically look at the retail environment and its rela­ tionship to children's nutrition-related beliefs and behaviors.4 the primary means of in-store marketing are front-of-package design (especially the depiction of characters popular with children) and the strate­ gic placement of the products within the store (e.g., placement in check-out aisles and free standing displays). packaging and displays are particularly important to capture the interest of young children who have limited ability to read.5 in fact, food companies use trained psychologists to create posi1. deborah john, consumer socialization of children: a retrospective look at twenty-five years of research, 26 j. consumer. res. 183, 192 (1999). 2. cynthia ogden et al., high body mass index for age among u.s. children and adolescents, 2003-2006,299 jama2401 (2008). 3. see, e.g., jonathan lynn, who recommends food marketing curbs for child obesity, reurers, jan. 21, 2011, available at http:llwww.reuters.com/article/2011/01/21/us­ food-safety-idustre70k4fu20110121; see also stacy finz. front labels on food for children called deceptive, s.f. chron., jan. 20, 2011, at a-1, available at http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/20 ll/01/20/mnjm1hbice.dtl. 4. see, e.g., jennifer l. harris et al., marketing foods to children and adolescents: licensed characters and other promotions on packaged foods in the supermarket, 13 pub. healtiinutrition 409 (2009). 5. billur ulger, packages with cartoon trade characters versus advertising: an empirical examination of preschoolers' food preferences, 15 j. fooo products marketing 104 (2009). 2012] government intervention in unhealthy food promotions 119 tive reactions in children upon seeing their products.6 the majority of foods marketed to children in retail stores feature characters on the packaging, which has been shown to manipulate children's food related beliefs and in­ duces them to request these products to their parents. 7 this promotional method undermines the parents' role as "nutritional gatekeeper'' and has been shown to strain parent-child interactions. 8 from the industry's perspective, "point-of-purchase materials" are "intended to lure young fans" of a popular character, movie or the like to the food product bearing the character, such as for pokemon cereal.9 for example, at the inception of barbie cereal, when 95% of girls ages three to ten owned at least one barbie, industry representatives explained that the product would be part of the ••exciting and glamorous world of barbie" and "extends the fantasy" for "little girls who •play barbie. "'10 this paper summarizes research concerning the extent of in-store marketing of foods to children and the effects of such marketing. next it identifies several different ways that the federal and state or local govern­ ments might regulate in-store and package-based marketing and industry arguments against such regulations. finally, it analyzes how courts would likely scrutinize the constitutionality of such regulations· to identify which approaches are most likely to make a positive impact on public health and succeed if challenged in court. ii. the retail environment a. background and definitions marketing within food retail establishment has been ·increasing and projections state that this is the "fastest-growing area of marketing invest­ ment for packaged-goods marketers. "11 the most recent industry reports indicate that 83% of food, beverage and consumer product marketers plan to increase investments into what the industry terms, "shopper market­ ing. " 12 shopper marketing is defined as, "the employment of any marketing 6. brian wilcox et al., report of the ap a task force on advertising and cmldren 20 (2004). 7. see part id.b., infra. 8. faq about the book, m:indlesseatlno.org, http://mindlesseating.org/faq.php (last visited oct. 30, 2011). 9. stephanie thompson, kellogg's new cereal goes pokemon, advertising age, mar. 13, 2000, at 6, available at http://adage.com/article/newslk:ellogg-s-cereal­ pokemonl59084/. 10. cyndee miller, cereal maker to kids: eat breakfast with barbie, marketing news, sept. 25, 1989, at 10 (internal quotation marks omitted). 11. jack ne~ shopper marketing trumps digital in spending plans for cpg mar­ keters, advertising age, nov. 9, 2010, available at http://adage.com/article/newslshopper­ marketing-trumps-digital-spending-plan~gll46959/. 12. sarah mahoney, shopper marketing grows faster than digital, social, 120 indiana heal til law review [vol. 9:1 stimuli, developed based on a deep understanding of shopper behavior, de­ signed to build brand equity, engage the shopper (i.e., an individual in "shopping mode"), and lead him/her to make a purchase."13 a study by the grocery manufacturers association (''gma'') and deloitte explained the premise behind shopper marketing: [m]anufacturers and retailers can together create a more engaging shopper experience, influencing shop­ pers at the point of purchase where they make most final buying decisions. shopper marketing is about using insights, . . . to deliver the right environment, right products, right packaging, right prices, and right marketing communication-combined to satisfy the shopper in a way that was not traditionally possible. 14 shopper marketing studies typically analyze shoppers in general so promotional techniques intended directly for children are not often reported separately. one exception is the technique termed, the "nag factor," defined as "an indirect path beginning with promotional activities influencing chil­ dren, who then request that their parent(s) buy the product, followed by the parent(s) making the decision and/or purchase."1s the retail environment is a concern for public health and child advocates because the majority of food targeted to youth in this venue is of poor nutritional value, and promotions encourage children to request (and prefer) these unhealthy products. the "bread and butter" of shopper marketing is considered to be prod­ uct packaging and in-store displays, ads, and promotions.16 this manu­ script will focus on the two main areas of shopper marketing: packaging and in-store promotions and displays, while touching on related tools. the defmitions used by the federal trade commission ("ftc") when it ordered forty-four food and beverage companies to disclose information on their marketing expenditures directed at children and adolescents (collectively ''youth") are helpful.17 mediapost pub. (nov. 9, 2010, 5:00 am), http://www.mediapost.com/publications/article/ 139107/. 13. gma & deloi'ite, shopper marketing sruov: deliver1ng the promise of shopper marketing 8 (2008). available at http://www.deloitte.com/assets/dcom­ unitedstates/localo/o20assetsidocuments/us -'cb _ cpg_ deloittegma _shopper _mkt _report_ 200810.pdf. 14. ld. 15. eileen bridges & richard briesch, the 'nag factor' & children's product cate­ gories, 251nt'lj.adver. 157,157-58 (2006). 16. gma sales comm. & booz & co., shopper marketing 4.0: building scalable playbooks tiiat drive results 5 (2010), available at http://www.gmaonline.orgldownloadslresearch-and-reports/shopper_ marketing_ 4.0.pdf. 17. for all ftc definitions, children were categorized as younger than twelve years and adolescents twelve to seventeen years old. see, e.g., fed. trade comm'n, marketing food to children and adolescents: a r.imew of industry expenditures, activities, 2012] governmentinterventioninunhealthyfoodpromotions 121 packaging includes all product packaging·and labeling (including all words and images) for any of the company's food products designed to ap­ peal to youth.18 according to federal law, written. printed, or graphic mat­ ter accompanying the product is considered part of the label, such as a shelf tag with a character promoting the product placed on the accompanying shelf.19 influential features on packaging were also independently measured by the ftc including the use of character licensing, toy co-branding, celeb­ rity endorsements, and cross-promotions-the linking of a food or beverage to a licensed character, a new movie, or a popular television program.20 in addition, the use of premiums was individually measured,· and premiums are defined as non-food· specialty items distributed in· connection with the product within food packages or by sale or the redemption of coupons, codes, or proofs ofpurohase.21 ln'-store advertising and promotions include "advertising displays and promotions at a retail site, including the offering of free samples and allowances paid to facilitate shelf placement or mer­ chandise displays" designed to appeal to youth.22 ·b. food promotions directed at children the ftc's food marketing report found that food and beverage and self-regulation 1 (2008) (hereinafter marketing food 10 children and adolescents], available at www.ftc.gov/os/2008/07/p064504foodmktingreport.pdf. 18. this includes: prominently featured youth-oriented licensed characters, celebrity endorsers, models or characters who are or appear to be· younger than· age ·eighteen, lan­ guage, such as "kid," "child," "tween," "adolescent," ~'teen," "teenager," or similar words, or youth-oriented themes, activities, incentives, products, or media. federal trade comm'n, marketing food ro children & adolescents: a review of industry expenditures, activities, & self-regulation: appendices b-16, b-30 (2008) (hereinafter marketing food 10 children and adolescents: appendices], available at http://www.ftc.gov/ os/2008/07/p064504fuodmktingreportappendices.pdf 19. the federal food, drug and cosmetic act defines label to mean "a display of written, printed, or graphic matter upon the immediate container of any article," 21 u.s.c. § 321 (k) (2009), and the term "labeling" means "all labels and other written, printed, or graph­ ic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article," 21 u.s.c. § 321(m) (2009). the supreme court found that the definition of labeling covered a pamphlet with literature about the product that was shipped with the product but also interpreted it to include the pamphlet if it was available separately. kordel v. united states, 335 u.s. 345, 347-50 (1948). in a case more on point, a district court re­ lied on this precedent to find that in-store statement: "vitamins + water = what's in your hand" that "accompanied the sale" of the beverage vitaminwater constituted labeling. ackerman v. coca-cola company, 2010 u.s. dist. lexis 73156, at *16, *25-26 (e.d.n.y. july 21, 201 0) (the court was not explicit but likely the statement was on a shelf-tag.). 20. marketing food to children and adolescents: appendices, supra note 14, at b-20, b-23-24, b-34-35, b-37-38. 21. id at b-18--19, b-32-33. 22. such design elements may involve the height of placement or display to reach youth, and the use of licensed characters, images of youth, and language such as "kid," "child," "adolescent" ''teen," "teenager," or similar words. marketing food to children and adolescents: appendices, supra note 14, at b-18, b-32. 122 indiana health law review [vol. 9:1 companies spent $195 million on packaging and in-store display materials to reach children and adolescents. 23 this represents 12% of all reported youth marketing expenditures and is second only to television advertising. 24 the products marketed to youth in this manner included in decreasing order of expenditures: snacks, breakfast cereals, carbonated beverages and can­ dy/frozen desserts, and juice and non-carbonated beverages.25 nearly $90 million ( 46% of all youth-directed expenditures for packaging and in-store marketing) was spent on teen-directed marketing of carbonated beverages alone.26 studies show that young children as well as teens are influenced by teen-directed marketing in the retail environment?7 the ftc found that integrated advertising campaigns, which combine several marketing techniques and often involve cross-promotions, dominate today' s landscape of food marketing to youth. cross-promotions are used in many media venues (e.g., television, packaging, internet), account for 13% of all reported youth-directed marketing expenditures, and involve the use of licensed characters spokescharacters, games, contests, sweepstakes, movie and television tie-ins, toys, and entertainment events.28 finally, the companies reported spending $67 million to reach youth through premiums, which accounted for 4% of all marketing expenditures. child-targeted breakfast cereals accounted for 93% of all expenditures on premiums (approximately $40 million).29 it is important to note that this does not represent all premiums directed at youth because the companies reported that cross-promotional partners often covered the cost of premi23. study of food industry marketing to children and adolescents; orders to file special report, ftc matter no.: p094511, fed. trade comm'n, http://www.ftc.gov/ os/6b_orders/foodmktg6b/p094511/index.shtm (last modified aug. 27, 2010) (in 2010, the ftc subpoenaed forty-eight food and beverage companies gain information advertising expenditures and methods for the year 2009 and to determine whether self-regulation was having the appropriate impact on marketing to children. some companies of the original forty-four were left off the new list and twelve new companies were subpoenaed); see also rich thomaselli, ftc subpoenas 48 food companies regarding marketing to kids, advertising age, sept. 1, 2010, available at http://adage.eom/article?article_id=l45675. 24. markering food to children and adolescents, supra note 13, at 8. 25. id 26. id. at 18 (the next largest in store expenditure was $18.2 million for snacks). 27. see phyllis ellickson et al., does alcohol advertising promote adolescent drink­ ing? results from a longitudinal assessment, 100 addiction 235 (2005), available at http://onlinelibrary.wiley.com/doillo.lll1/j.1360-04432005.00974.x/pdf (reporting. that, among other findings, for seventh-grade non-drinkers, exposure to in-store beer displays predicted drinking onset by grade nine); sandy slater et al., the impact of retail cigarette marketing practices on youth smoking uptake, 161 archives of pediatric & adolescent med. 440 (2007), available at http://archpedi.ama-assn.org/cgilreprint/16l/5/440.pdf (find­ ing that cigarette retail marketing practices increase the likelihood of smoking uptake in youth); cf hazelwood sch. dist v. kuhlmeier, 484 u.s. 260, 274-75 (1988) ("it was not unreasonable for the principal to have concluded that such frank talk was inappropriate in a school-sponsored publication distributed to 14-year-old freshmen and presumably taken home to be read by students' even younger brothers and sisters."). 28. marketing food to children and adolescents, supra note 13, at 8. 29. id at 19. 2012] government intervention in unhealthy food promotions 123 ums.3o -in 2005, the institute of medicine ("10m'') found that child-targeted food products are high in total calories, sugars, salt, fat, and low in nutri­ ents.31 the food identified by the ftc study as those most promoted to children in 2006 through packaging, premiums, and in-store marketing are considered non-nutritious by objective nutrition criteria and scientific re­ search: snacks, breakfast cereals, carbonated beverages, candy, frozen des­ serts, and non-carbonated beverages.32 more recent studies have confirmed that this environment has not improved despite the fact that in 2006 the council of better business bureaus and leading food and beverage compa­ nies launched the children's food and beverage advertising initiative ("cfbai'') "to shift the mix of advertising primarily directed to children cchild-directed advertising') to encourage healthier dietary choices and healthy lifestyles."33 c. industry self regulatory pledges and nutritional quality of food pro­ moted to youth fifteen packaged food and beverage manufacturers are members of the cfbai. 34 through their pledges, these companies vowed to restrict their 30. id. partners, such as a toy or media company, often covered the premium costs, such as sweepstakes prizes or dvd rebates. id. 31. comm. on food mktg. and nm diets of children and youth. inst. of med., food marketing to cidldren and youm: threat or 0ppor1unity? 163 (2005). 32. jennifer l. harris et al., yale rudd center for food poucy & obesity, cereal f.a.c.t.s.: evaluating tile nutri110n quality and marketing of cidldren's cereals (2009), available at http://www.cerealfacts.org/media/cereal_f acts_ report.pdf. for example, carbonated beverages and other sugar-sweetened drinks have been determined to be the largest single contributor to obesity and an independent risk factor for diabetes and heart disease. vasanti malik et al., sugar-sweetened beverages, obesity, type 2 diabetes mellitus, and cardiovascular disease risk, 121 circulation 1356 (2010); vasanti malik et al., intake of sugar-sweetened beverages and weight gain: a systematic review, 84 am. j. cunical nu1rition 274 (2006); samara nielsen & barry popkin, changes in beverage intake between 1977 and 2001, 27 am. j. preventive men. 205 (2004); david ludwig et al., relation between consumption of sugar-sweetened drinks and childhood obesity; a prospective, observational analysis, 357 the lancet 505 (2001) (finding that a child's risk ofbecoming obese increases by 60% for each serving of sugar sweetened beverage the child drinks each day). 33. about children's food and beverage advertising initiative, better business bureau, http://www.bbb.org/us/about-children-food-beverage-advertising-initiative/ (last visited feb. 26, 2012). 34. the food companies are: cadbury adams, usa. llc, campbell soup company, the coca-cola company, conagra foods, inc., the dannon company, general mills, inc., the hershey company, kellogg company, kraft foods global, inc., mars, inc., nestle usa. pepsico, inc., post foods. llc, sara lee corp., unilever united states. two restau­ rants are also members but are not included in this analysis: burger king corp., mcdon­ ald's usa. see .karlene lukovitz, industry unveils new marketing-to-kids standards, mediapost pub. (july 15, 2011, 9:29am), http://www.mediapostcom/publicationslarticle/ 154139/industry-unveils-new-marketing-to-kids-standards.html. 124 indiana heal1h law review [vol. 9:1 use of certain marketing practices v>ia specific media to food that meets their own internal nutritional criteria. 35 although each company's pledge is unique, the cfbai announced thatuniform nutrition standards would be launched on december 31, 2013.36 the stated goal of cfbai is to promote and support healthier dietary choices and healthy lifestyle to children under twelve years of age.37 how­ ever, the cfbai core principles statement explains that participants' commitments explicitly exclude point of sale materials, packaging, and the use of company-owned characters.38 no pledge covers in-store marketing and only two companies have a minimal exception· for their products' pack­ aging; kellogg's and general mills restricts their use of third-party child­ directed licensed characters on· packaging according to internal nutrition standards.39 however, both of these companies have a wide variety of well­ established company spokescharacters for their products intended for chil­ dren (e.g., the lucky charms leprechaun, thetrix rabbit, tony the tiger, and snap, crackle and pop) that they use on:their packaging. there are no pledges addressing the use of company spokescharacters on packaging or in-store promotions. child-targeted food product packag;.. ing also bears other promotions including the . use of premiums, cross­ promotions, tie-ins· for movies and television shows, games, puzzles, con­ tests, sweepstakes, special colors, shapes or flavors, and claims or allusions to fun.40 35. core principles statement states that the pledges cover some or all of the follow­ ing media: television, print, radio, internet, video/computer games, dvds, cell phones, pdas, and word of mouth advertising. see be'iter business bureau, children's food & beverage advertising initiative program & core principles statement (201 0), avail­ able at http://www.bbb.orglus/storage/o/shared%20documents/enhancedo/o20core% 20principleso/o20thirdo/o20editiono/o20-o/o20letterhead.pdf. . 36. about children's food and beverage advertising initiative, beiter business bureau, http://www.bbb.org/us/about-children-food-beverage-advertising-initiative/ (last visited feb. 26, 2012). 37. the pledges state that the companies will limit the use of one or all of the follow­ ing: licensed characters, celebrities, athletes and movie-tie-ins, to covered media according to their own internal nutrition criteria. eight of the pledges say they do not advertise to chil­ dren under six years old. see id; see also pre-2010 company pledges, better business bureau, http://www.bbb.org/us/children-food-beverage-advertising-initiative/pledges/ (last visited oct. 1, 2011). 38. better business bureau, supra note 33 (unilever and campbell's soup also explicitly exclude packaging and in-store prolllqtions ftom their pledges), 39. jd. general mills limits its use of third-party child-directed licensed characters to packaging for products that meet its healthy dietary choice criteria and sugar guideline. better business bureau, the children's food & beverage advertising initiative in action: a report on compuance and implementation during 2008 34 (2009), availa­ ble at http://www.bbb.org/us/storage/0/sharedo/o20docunients/:tinalbbbs.pdf. kellogg's limits its use of child-directed licensed characters on the front panels of its packaging and as the basis for its ''food forms," to products that meet its nutrition guidelines. better business bureau, supra note 33, at 4 n.5. 40. charlene elliott, assessing 'fun foods': nutritional content & analysis of su­ permarket foods targeted at children, 9 obesity reviews 368 (2008); marketing food 2012] government intervention in unhealthy food promotions 125 the food retail environment has not improved since the initiation of the cfbai because packaging is not included in the pledges.41 researchers found that from 2006 to 2008, the u.s. supermarket environment has de· clined. only 73 of 397 foods (18.4%) assessed in one study met 10m standards of healthy; thus over 81% of the foods promoted to children were unhealthy according to these objective nutrition criteria.42 further, 790/o of all food package promotions were directed at children under twelve, with 22% directed at preschool·age children and 57% directed at children. 43 from 2006 to 2008, many companies increased their use of promotional methods not covered by the cbbb pledges, for example targeting an older youth audience or tie· ins to non·media partners such as toys and games. 44 a 2008 study of cereals found that those most marketed to children are the least healthy of the companies' products lines.45 children's cereals contain 85% more sugar, 65% less fiber and 60% more sodium compared to adult cereals, but they all meet the companies' self·regulatory pledges.46 in a 2011 study of fifty·eight children's products considered "better-for-you" by members of the cfbai, only nine products met objective nutrient crite­ ria.47 the study revealed that 93% of the cereals, 90% of the snacks and 75% of the beverages were high in sugar according to government nutrition standards.48 further, of the prepared meals, approximately one-third were high in saturated fat, low in fiber, and high in sodium.49 thus, despite the e:x,istence of the cfbai, concerns remain because the pledges are not based on strong nutritional criteria and exclude key to children & adolescents, supra note 13, at 1; harris et al., supra note 4. 41. see rudd center for food poucy and 0bilsity, supra note 28 (for example, in 2008, preschoolers saw 642 cereals ads, children saw 721 cereal ads and 800/o of them had the worst nutrition ratings (85% more sugar, 65% less fiber, and 60% more sodium than those advertised to adults)). 42. harris et al., supra note 4. 43. id. see also elliott, supra note 36. a study of foods targeted to children in a ca­ nadian supermarket (excluding confectionary, soft drinks, and bakery items) found them to be 89% of poor nutritional value. three out of four of the products targeted to children had a cartoon image on the front of the box. it is also noteworthy that 63% of all the foods target­ ed to children had one or more nutrition claims and 62% of the foods of poor nutritional value had one or more nutrition claims. this is problematic because the use of characters, games, colors, etc. are used to attract children to the products while the nutrition claims are used to either attract or appease parents when their children request the product. see also kathy chapman et al., the extent & nature of food promotion directed to children in australian supermarkets, 21 health promotion .int'l 339 (2006), available at http://heapro.oxfordjoumals.org/content/2114/331.full.pdfthtml. for seven food categories in australian supermarkets that were promoted to children (sweet biscuit, snacks, confec­ tionary, chips/savory, cereals, dairy snacks, icchnajd), 82% were unhealthy. 44. harris et al., supra note 4. 45. rudd center for food poucy and obesity, supra note 28. 46. id 47. the prevention institute, claiming health: front-of-package labeling of children's food 6 (2011), available at http://www.preventioninstitute.orglcomponent/ jlibrary/articleldownload/id-593/127 .html. 48. id. 49. id. 126 indiana health law review [vol. 9:1 marketing venues. since the pledges do not cover retail marketing tech­ niques and package promotions (with two minor exceptions), they are not comprehensive enough to protect children in the retail environment. if the government believes it must step in because the cfbai does not adequately regulate companies' marketing of unhealthy products to children, the mem­ bers will have missed their opportunity to self-regulate and may be subject to regulation. 50 iii. research on effectiveness of child-targeted promotions the seminal paper on children's development as consumers is john's analysis of twenty-five years of consumer socialization research on chil­ dren. 51 john found that young children are attracted to perceptually salient features of marketing, regardless of whether it is relevant to the product. 52 this means that young children notice immediate and readily observable perceptual features in the marketplace, such as size or color of a product. 53 children pay little attention to relevant product information and have "rela­ tively undeveloped notions about how prices reflect the valuation of goods and services."54 it is not until early adolescence that youth perceive the full range of connections between product, price, and value. 55 john's review of consumer research found that children under age eight "are seen as an at-risk population for being easily mislead by advertis­ ing" because those children do not understand the persuasive intent of mar50. although the industries are quite different. a similar situation has evolved in to­ bacco retail. in a study of 3 to 6 year olds, researchers found that 90% of the six year olds correctly identified old joe camel as associated with cigarettes (the same percent who rec­ ognized mickey mouse). paul fischer et al., brand logo recognition by children aged 3 to 6 years: mickey mouse and old joe the camel, 266 jama 3145 (1991). this was at a time when tobacco advertising stated that they did not advertise to children and had ceased to advertise on television. therefore. the children's knowledge about cigarette brands came from billboards and in-store promotions. in 1998, tobacco companies entered into the master settlement agreement. agreeing to limit many marketing practices and youth access to to­ bacco. however, this resulted in an increase in tobacco retail marketing and promotions. slater et al., supra note 23. for example, in 2003, 94% of all tobacco industry advertising and promotions were directed at the retail environment. congress passed the family smok­ ing prevention and tobacco control act, directing the fda to issue regulations to address some of these practices. 21 u.s.c. § 387a-1(ax2)(2009). 51. john, supra note l. 52. id. at 198. in one study, children were asked to choose a candy for their friend who likes chocolate and raisins but not peanuts and were shown cards with visual candy ingredients. over two-thirds of the kindergartners chose the candy with the most ingredients on the card, regardless of their relevance to the request. in contrast. almost two-thirds of third grade students used one of the information requests to make the choice. 53. ld.. at 187. 54. id. at 196; see also bridges & briesch, supra note 11, at 169 table 1 ("children are typically unaware of price promotions."). 55. jd.; see also bridges & briesch, supra note 11, at 169 table l. 2012] government intervention in unhealthy food promotions 127 keting. 56 although most of the research is based on television marketing to children, there has been an increase in integrated marketing and it may be difficult to tease out the effect from the diverse and numerous influences. however, the comprehensive nature of marketing makes this less perti­ nent.57 there is a body of research on in-store promotions and packaging reviewed below that reveals efficacy of marketing in the venue and reveals why current self-regulatory pledges that exclude the retail environment are wholly ineffective. a. in-store promotions within the retail environment, in-store displays, ads, and promotions are used to entice shoppers to products. 58 for adults and children alike, in­ store promotions work in two ways: either they directly promote the pur­ chase of a product or reinforce the marketing experienced through other venues prior to entering the store. first, product promotions directly promote purchase by influencing in­ store decisions and impulse purchases.59 the gma reported that 73% of shoppers make at least one impulse purchase in the food and beverage cate­ gory per shopping trip (as compared to 41% and 39% in the household and healthy/beauty categories, respectively).60 further, checkout aisles are lu­ crative venues for impulse purchases; hence, some suppliers pay fees to retailers for shelf space located near checkout registers. 61 in fact, the advent of self-checkout aisles had the unintended consequence for retailers of de56. john, supra note 1, at 190. 57. in its 2006 report, food marketing to children and youth: threat or opportunity, the institute of medicine analysis of the scientific literature led the committee to conclude that "most children ages 8 years and under do not effectively comprehend the persuasive intent of marketing messages, and most children ages 4 years and under cannot consistently discriminate between television advertising and programming." comm. on food mktg. and the diets of cmldren and youth, supra note 27, at 9. experts consider television marketing to these young groups to be deceptive because they cannot differentiate between commercial and non-commercial speech; this is a deceptive way to propose a commercial to them. id. at 309. 58. gmasalescomm.&booz&co.,supranote 12,at5. retail promotions of tobacco and alcohol are correlated with increased youth uptake for those products. see ellickson et al., supra note 23 (among other findings: for seventh-grade non-drinkers, exposure to in-store beer displays predicted drinking onset by grade nine); slater et al., supra note 23 (finding that cigarette retail marketing practices increase the like­ lihood of smoking uptake in youth). 59. ryan hamilton & dipankar chakravarti, symposia summary: new insights in consumer point-of-purchase decision making, 35 aov ances consumer res. 52 (2008). 60. grocery mfr's. ass'n sales comm., shopper marketing 3.0: unleasidng the next wave of value 2009. 61. fed. trade comm'n, slotting allowances in the retail grocery industry: selected case studies in five product categories 57 (2003), available at http://www.ftc.gov/os/2003/lllslottingallowancerpt03ll14.pdf. 128 indiana health law review [vol. 9:1 creasing impulse purchases and reducing profits.62 the president of a retail­ consulting firm dubbed this new system ''the self-checkout diet" after re­ ports surfaced that self-checkout decreased impulse purchases, resulting in a large decrease in food and beverage calories purchased. 63 second, retail promotions reinforce other marketing experiences through integrated marketing campaigns. the gma explained that even when a shopper may know the type of food he or she is going to purchase, 60% of brands are selected in the store. 64 this means that in-store market­ ing is used to "reinforce those preferences and 'close the deal' in the store.'o65 promotions are integrated across marketing strategies so in-store experience supports out of store advertising techniques. for example, at home a consumer may see a commercial for a product that includes a com­ pany spokescharacter and then upon entering the retail establishment, the consumer sees the spokescharacter on the product packaging to reinforce the previous. positive attributes of the product displayed on the commercial. the gma report explained that the goal is to have all out of store market­ ing intersect with in-store promotions. 66 the gma found that the most effective vehicles for product purchase were on and off-shelf displays and advertising, in-store events, and sam­ pling.67 in-store displays that have the greatest impact on sales and impulse purchases were found to be "special displays/' which include end-of-aisle displays, or within-aisle displays such as cardboard platforms, bins or bas­ kets holding the products.68 end-of-aisle displays seem to have a particular­ ly strong impact on sales,69 and industry characterizes them as "ground zero for 'in-store decision making,"' because they are unavoidable and thus, ''the best chance of getting into the passing baskets of harried shoppers.''70 62. evan schuman, self-chec/cout killing impulse items, storefront backtalk (july 25, 2006), http://storeftontbacktalk.com/payment-systems/self-checkout-killing­ impulse-items/. 63. id. (when going through self-check out, purchase of "chips and salty snacks dropped 53 percent," and soda and water, dropped 50 percent. "on average, we believe that self-checkout will save somebody two-and-a-half-pounds a year."). 64. grocery mfr.'s. ass'n sales comm., supra note 61. 65. id 66. id ("[i]n order to unleash the full potential of shopper marketing, it must be inte­ grated with other demand-generation activities all along the path to purchase."). 67. gma sales comm. & booz & co., supra note 12, at 22. 68. j.b. wilkinson et al., assessing the impact of short-term supermarket strategy variables, 19 j. marketing res. 72 (1982) (special displays have a greater impact on sales and impulse purchases than regular or expanded shelf space and are widely used as promo­ tional techniques.). jeffrey inman et al., the interplay among category characteristics, customer characteristics, & customer activities on in-store decision making, 73 j. marketing 19, 19-29 (2009). gma sales comm. & booz & co., supra note 12, at 22. 69. ana valenzuela & pierre chandon. symposium summary: attentional and infer­ ential effects of point-of-purchase marketing, 36 advances consumer res. 100 (2009). 70. brandon copple, shelf-determination, forbes.com (apr. 15, 2002), http:/ /www.forbes.com/forbes/2002/0415/130 _print.html. 2012] government intervention in unhealthy food promotions 129 most publicly available studies on the effect of in-store promotions focus on adults; however, gma publications recognize children are also consumers. 71 there are various promotional techniques employed to attract children to products or to keep them occupied or engaged so parents can shop. these techniques include locating child-targeted food products at their eye level, placing toys and other promotional items near the most mar­ keted foods products, providing free food samples, erecting colorful dis­ plays or attractions with which children can interact, and having kids clubs.72 one study found that shelf placement had a bigger impact on sales than increased shelf space and this was particularly true in the breakfast cereal category, likely "due to the important role that children play in this category."73 for in-store methods to induce children to request products, researchers found that low level shelf placement had a larger impact on children than special displays.74 the former president of harris teeter gro­ cery chain explained that: "eye level equals buy level;" thus, "slower­ moving items are on the top shelves, harder to find, and thus reserved for the 'destination shopper. ,.75 in-store methods to reach children, whether in special displays or on­ shelf displays, have the intended effect of influencing purchases and pur­ chase requests by youth. studies reveal that children make purchase re­ quests in the retail environment by brand name of the foods most promoted to youth: breakfast cereal, snacks and, beverages. 76 71. gma & deloitte, supra note 9, at 7 (marketers and retailers ''recognized that a child (the consumer) and a mother (the shopper) transition from diapers to training pants in a similar way. as the child feels he/she is 'growing up,' the mother also experiences a sense of achievement that the diaper stage is over."). 72. grocery mfr's. ass'n sales comm., supra note 61 {in-store sampling programs are considered "an attractive way to build trial and drive impulse purchases." even if geared towards adult in marketing material, promotional people or those behind bakery or deli coun­ ters offer samples to children.). see also grocers say best place to influence consumers is in store, associated press, aug. 30, 1993, at 7 (grocers hire professional food demonstra­ tors to offer samples, tout the product and gamer customer reaction.). see also jeff cioletti, super marketing: child's play, supermarket bus., july 15, 2001, at 24. 73. xavier dreze et al., shelf management and space elasticity, 70 j. retailing 301, 318 (1994). 74. bridges & briesch, supra note 11, at 178. 75. hank cardello, stuffed: an insider's look at who's {really) making americafat33 (2009). 76. mary story & simone french, food advertising and marketing directed at chil­ dren and adolescents in the u.s., int'l j. behavioral nutrition and·physical activity (feb. 10, 2004), http://ijbnpa.org/eontent/l/113 (finding that children's first in-store requests are often for the brand name of the product: breakfast cereal (47%), followed by snacks and beverages (300/o) and correspond with the products most highly marketed to youth.); comm. on food mktg. and the dmts of children and youth, supra note 27, at 103-04 (in one study observing requests by children aged 3-11 years to their mothers over a 30 day period. the study found that food accounted for 55% of the total requests made, including: snack and dessert foods (24%), candy (17%), cereal (7%), quick serve restaurant foods (4%), and fruit and vegetables (3%).). 130 indiana health law review [vol. 9:1 marketers use promotional activities to influence children to request their parent purchase their products.n this marketing method that encour­ ages children to make purchase requests is referred to as the ''nag factor," 78 "pester power ;m and "kidfluence"80 in the marketing literature. as one marketing researcher explained, the ''young audience does not necessarily understand the purpose of advertising and may trust messages that imply unhealthy foods are good for you.'.s1 the american psychological association's task force on advertising and children ("apa task force") found that marketing companies hire "people trained as child psychologists that specialize in market research on children" to apply "principles in developmental psychology" to the goal of more effectively persuading children to " influence their parents to purchase these products.'.s2 the apa task force found that, "[a]n important side effect of the influence of advertising on children's desire for products is the parent-child conflict that emerges when refusals occur in response to chil­ dren's purchase-influence attempts,'' and this "may place strain on parent­ child interaction. "83 the task force relied on several studies that revealed child disappointment, anger, and arguing were common responses to paren­ tal refusal for food products at the supermarket. 84 the marketing literature confirms this outcome. in an oft-cited study from the journal of marketing, researchers observed 516 parent-child (aged three to twelve) interactions in the cereal aisle.85 they found that 66% of the time, the child initiated the cereal selection ( 46% by demand and 20% by request) and the parent agreed more than half of the time.86 however, in cases where the parent denied the request, conflict emerged 54% of the time and child unhappiness 48% of the time. 87 both conflict and unhappiness 77. bridges & briesch, supra note 11. 78. directing the pitch: do smart marketers to children target kids or their par­ ents?, youth markets alert (factivia, inc.), july l, 1998, at 1 (discussing ''targeting kids with the nag factor"). 79. grilly, punctured neighbour, (oct. 21,2004, 1:14pm), http://grilly.blogspot.com /2004/10/text-from-bemard-matthews-trade-ad-we.html ("over the years we have continual­ ly innovated, successfully harnessing pester power to become the true market leader."). 80. james mcneal, tapping the three kids' markets, am. demograpmcs, apr. 1998, at 37-41 (discussing the "dollar value of the 'kidfluence' market ... about 90% of product requests made by children to a parent are by brand name."); see also anne suther­ land & beth thompson, kldfluence: the marketer's guide to understanding and researching generation y --kids, tweens, and teens (2003). 81. bridges & briesch, supra note 11, at 159. 82. brian wilcox et al., report of tiffi apa task force on advertising and chiwren 20 (2004). 83. see id. at 11. 84. seeid. 85. charles atkin, observation of parent-child interaction in supermarket decision­ making, 42 j. marketing 41 (1978). 86. id 87. /d. 2012] government intervention in unhealthy food promotions 131 occurred most in the 6 to 8 year age range.88 the commercial interest in promoting nagging likely interferes with the parent or guardian's role as the "nutritional gatekeeper." the nutritional gatekeeper is the person in the household who buys and prepares food. 89 former executive director for the usda's center for nutrition policy and promotion, dr. brian wansink, found that this person's purchases control approximately 72% of all of the food decisions of their children and spouse, for the better or for the worse. 90 b. paclmging and paclmging promotions package-based advertising is especially important for children. the product's packaging brings all other advertising and promotional efforts together in one place91 and is considered one of the "most efficient market­ ing tools" for reaching child and adult consumers alike.92 the packaging has been deemed to have the most impact on sales among all shopper mar­ keting methods: packaging plays an integral role and has a major im­ pact on shopper marketing. when a consumer is walking down an aisle and stumbles upon a shelf talker, floor ad or end-aisle display, it is the packag­ ing that will often result in that ftrst moment of truthh h d .. 93 -t e pure ase ectston. further, packaging is considered more important than traditional and new digital media by some marketers. first, packaging has "a longer shelf life" than advertising and "it will be seen by more people" because there is no other vehicle that consumers interact with on a daily basis.94 second, because the "average consumer is bombarded with anywhere from 250 to 5,000 media messages each day,"95 it "has become most challenging to connect with your consumer through any one medium" (e.g., tv, maga88. !d. 89. tara parker-pope, who's cooking? (for health, it matters), n.y. times. (mar. 16, 2009), http://www.nytimes.com/2009/03/17/health/17well.htrnl?_r=2; see also faq about the book, mindlesseating.org, http://mindlesseating.org/faq.php (last visited oct. 30, 2011). 90. f aq about the book, supra note 96. 91. joseph difranza et al., cigarette package design: opportunities for disease prevention, 1 tobacco induced diseases 97, 97-98 (2002). 92. russ napolitano, packaging can be your best investment, in shopper marketing: how to increase purchase decisions at tile point of sale 215, 216 (markus stahlberg et al., eds., 2010). 93. !d. at 221. 94. !d. at 216--17. 95. !d. at 216. 132 indiana health law review [vol. 9:1 zines, newspapers, .billboards, internet, phones, blogs, games, etc.), so the packaging is the most important vehicle to make an impression and induce sales.96 therefore, savvy manufactw'ers are encouraged to make "packag­ ing to entertain, engage and excite" consumers.97 researchers have explained the importance of packages' communica­ tion to promote children's attraction to the products based on their limited cognitive abilities.98 one professor of marketing explained that the age span food marketers target for their packaged food is three to seven years old. 99 this makes sense for a number of reasons. very young children cannot read or recall brand names, so attractive features such as cartoon characters are more important to their desire for a product than other aspects of the package.100 they are also less capable of storing and retrieving in­ formation so even if they enjoy a product commercial, it may not translate into purchase behavior or requests.101 thus, packaging stimuli directed at this young age group can be the most influential to induce desire for the product.102 studies reveal that promotions on and in food packaging are influen­ tial on children's purchase requests, preferences and tastes. certain promo­ tional techniques are particularly effective and others have yet to be studied. a review of this research follows. i. licensed characters and company spolr£scharacters visual recognition of a brand is important to capture young children's interest who have seen ads for the product but have a limited ability to read or recall brand names. 103 children as young as ages two to three years can recognize familiar packaging in the stores and familiar spokescharacters on food products.104 researchers have explained that visual recognition on 96. /d. 97. id. at 217. see also difranza et al., supra note 98 (researchers within the tobacco context explained the impact and purpose of packaging as follows: "the package is the ultimate communication tool, the last step in the promotional process. the package should shape consumer expectations about the product in terms of quality and image. packages are designed to be eye catching and·attractive, to have visual impact both when seen alone, as in use, and when amassed in great quantities. as in large retail displays. when the package is displayed in the store, it is the sum of the ~ the package, and the associated imagery that is purchased by the consumer."). . 98. billur olger, packages with cartoon trade characters versus advertising: an empirical examination of preschoolers' food preferences, 15 j. food products marketing i 04 (2009). 99. dick mizerski,lssues concerning the effects of advertising on children, 24 lm'l j. advertising 399 (2005). 100. olger,supranote 106. i 01. ld; see also bridges & briesch. supra note ii, at 163. 102. olger, supra note 106. 103. ld 104. john, supra note 1, at 189; story & french. supra note 81 (stating that children 2012] government intervention in unhealthy food promotions 133 product packaging induces young children's desire for products even when they do not understand the functional benefit of the product.10s an anec­ dote from the book food fight captures this precisely: a mother recounts shopping in the supermarket with her child aged four who sees betty crocker's disney princess fruit snacks with cinderella, snow white, and the little mermaid on the box. the child says, "i want that." the mother asks "what is it?" and the child responds, "i don't know."106 spokescharacters and licensed characters become important attractive features on product packaging.107 it is thus not surprising that the majority of food marketed to children has some sort of cartoon character on the front of the package.108 very popular licensed characters adorn dozens of differ­ ent types of food products. for example, spongebob squarepants is on products ranging from fast food to cereal to cookies.109 three studies, in particular, of identical food offerings to children, one bearing a licensed character and one without, revealed that the licensed character induces children to prefer the taste of the food and select that item for a snack.110 in a 2005 study by sesame street workshop, researchers first request products at about two years of age and 75% of these requests occur in the su­ permarket). 105. ulger, supra note 106. 106. kelly brownell & kathbr1ne borgen, food fight: the inside story of the food industry, america's obesity crisis, and what we can do about it 106--07 (2004); see also susan linn, remarks in consuming kids: the commercialization of childhood 8 (media education foundation 2008) (transcript on file with author) ("spongebob squarepants was kraft's best selling macaroni & cheese. i personally know a five year old who told her father, in no uncertain terms, that spongebob squarepants maca­ roni &cheese tastes better than any other macaroni & cheese. now, how do you argue with a 5 year old about that? what do you say? you say, 'no it doesn't,' and then she says, 'yeah it does.' ... 'well, have you ever had spongebob squarepants macaroni & cheese?' 'no, but i know that it tastes better.'"). 107. see michael rich, remarks in consuming kids: the commercialization of cmldhood 8-9 (media education foundation 2008) (transcript on file with author) ("grow­ ing up is a very strenuous, difficult, and sometimes bard and scary process for children. one of the things that gives them some stability and continuity in that is their attachment to touchstones in their lives. and among those touchstones are characters: clifford the big red dog, mickey, mouse. these are constants in their lives. these are things that 1hey have figured out, they feel they understand, and that they feel comfortable with, and indeed, in their owil way, love. when you take that, and you leverage that into saying, 'eat this food,' you are basically leveraging that very powerful emotion that the child has-that very power­ ful attachment-to make money."). 108. elliott, supra note 37 (3/4 products: cartoon on box front)~ 109. press release, parents beware: spongebob movie rife with commercialism, campaign for commercial-free childhood (nov. 16, 2004), http://www.oommercialftee childbood.orglpressreleases/spongebob.htm. 110. see also matthew lapierre et at., influence of licensed spokescharacters and health cues on children's ratings of cereal taste, 165 ar.ciuves pediatric & adolescent med. 229, 231-32 (2011) (comparing fourto six-year-olds' taste preference for cereal with or without a character, children liked the same cereal with the character but there was also a difference based on the use of a different name for the cereal); thomas rob­ inson et al., effects of fast food branding on young children's taste preferences, 161(8) archives pediatric & adolescent med. 792, 793-94 (2007) (demonstrating that when researchers gave sixty-three children aged three to five years identical food and beverages in 134 indiana health law review [vol. 9:1 asked children. to choose between broccoli and chocolate; 22% chose the broccoli and 78% of chi1dren chose the chocolate. ill however, when the researchers paired a sticker of a popular sesame street character elmo with the broccoli and an unknown character with the chocolate, 50% of the chil­ dren chose each product. 112 lastly, when researchers put the elmo sticker on the chocolate and the unknown character sticker on the broccoli, 89% chose the chocolate, and 11% chose the broccoli.1 13 this study indicates that popular characters attract children significantly more than no character or an unknown character.114 a 2010 study corroborated the findings above. 115 children aged four to six were presented with two identical samples of one of three different types of foods (gummy bears, graham crackers, and baby carrots), but one sample bore a sticker of one of three characters: scooby doo, dora the ex­ plorer, and shrek.116 the children were asked to taste both samples and say which one tasted better. the majority of the children preferred the taste of the snacks across all 3 food categories that had the licensed-character on the package, with 72.5% choosing the carrots, 85% preferring the gummy bears, and 87.5% choosing the graham crackers with the licensed characters on them. 117 third, an interesting study published in 2009 with turkish children revealed that licensed characters on product packaging had a significantly greater effect on their food preference than seeing a commercial for an al­ most identical product.ll8 researchers divided 144 preschool, six-year-old children into two statistically equivalent groups; both watched approximate­ ly 50 minutes of bugs bunny cartoons with the treatment group also view­ ing 8 commercials inserted between episodes for chocolate wafer .. b." (the commercials were humorous, dynamic and contained child actors. 119) branded mcdonald's packaging or in plain packaging, the study subjects significantly pre­ ferred the taste of the food and beverages in the branded packaging, including carrots, which mcdonald's did not offer at the time of the study). 111. press release, "if elmo eats broccoli, will kids eat it too?" atkins foundation grant to fund further research, sesame workshop (sept. 20, 2005), http://archive. sesa­ meworkshop.org/aboutus/inside_press.php?contentld=l5092302; see also jennifer kotler, healthy habits for life: a great start to a lifetime of good health (2007). 112. "if elmo eats broccoli, will kids eat it too?", supra note 120; see also kotler, supra note 120. 113. kotler. supra note 120. 114. a similar result was seen when comparing the preferences for banana and grapes. see kotler. supra note 120; but see lapierre, supra note 119, at 229-34. in this study of 80 four-to-six-year-olds' subjective taste of cereal from a box bearing a licensed character or no character, only six children did not recognize the character but this did not influence their taste assessment. children who saw the character liked the cereal more than those without the character on it. 115. christina a. roberto et al., influence of licensed characters on children's taste and snack preferences, 126 pediatrics 88, 88 (201 0). 116. jd. at 90. 117. ld. at 91. 118. ulger, supra note 106. 119. id at 110-111. 2012] government intervention in unhealthy food promotions 135 after the viewing, both groups were asked to choose between chocolate wafer "b" that has a plain red package or chocolate wafer "a" that had a disney cartoon character on the red package. the majority of both groups (control group/no commercials 68%; treatment group/with commercials 78%) chose the chocolate wafer with the cartoon character on it.120 the majority of the research is on licensed characters, but company spokescharacters similarly attract children to the product. company spokescharacters have also been shown to produce favorable brand attitudes and increase brand awareness among children.121 marketing researchers found that the most effective marketing campaigns involve spokescharac­ ters and that spokescharacters are more important than verbal communica­ tions in advertising campaigns to promote brand recall and favorable brand attitudes. 122 industry research makes no distinction among characters that appeal to young children or differentiate among different types of characters to induce the "nag factor."123 spokescharacters can either reflect their brand attributes or not. the classic example is snuggle bear is the spokescharacter for snuggle fabric softener and his very being suggests softness. in the food context, buzz, the honey nut cheerio bee, references honey. conversely, tony the tiger does not have any basic relevance to the sugar coated corn flakes cereal, frosted flakes. 124 the latter type of spokescharacters have developed rele­ vancy to the product over time and through advertisements.125 but even perceptually relevant spokescharacters need to develop meaning over time or though integrated marketing campaigns. for example, the energizer bunny was not immediately recognizable as a figure for the energizer brand of batteries as opposed to a competitor's batteries.126 because the company's research found that consumers did not recall which battery brand was associated with the bunny, energizer introduced the bunny onto its product packaging and the association stuck. 127 2. other package promotion techniques the use of characters is the most studied feature ofproducts intended 120. id. at 111-112. 121. judith a. garretson & scot burton. the role ofspokeschracters as advertisement and package cues in integrated marketing communications 69 j. of marketing 118, 118 (2005). see also marketing food to children and adolescents, supra note 13. 122. garretson & burton, supra note 130, at 127. 123. see bridges & briesch, supra note 11, at 158-59. 124. garretson & burton, supra note 130, at 118-19. 125. tony the tiger ftrst appeared on cereal boxes in 1958 and now he is a well known ftgure for the cereal. see company history, kellogg's, http://investor.kelloggs.com lhistory.cfm (last visited mar. 19, 2012). 126. garretson & burton, supra note 130. 127. id. 136 indiana health law review [vol. 9:1 for children; however, research has shown that other tactics also have an effect. premiums have been shown to increase short-term sales of products when children desire the item over the associated food and can also elevate the image of that brand in children's minds.128 in a marketing observational study of parent-child interactions in the cereal aisle, researchers found that 9% of the children ( 6% of 3-5 year olds, 8% of 6-8 year olds and 11% of 912 year olds) explicitly identified the premium as the primary reason for the cereal selection.129 if parents refused, these children expressed "marginally more unhappiness" than children who were not premium-oriented. 130 by preschool, children can recall brand names if they are "associated with salient visual cues such as colors, pictures, or cartoon characters."131 for young children, these visual cues are needed to induce brand memory and recognition. older children are able to recognize that a brand name is a distinct aspect of the product packaging. 132 marketing research explains that these older children's attitudes to a brand "is of the utmost importance" to measure the effectiveness of advertising because "marketers of very simi­ lar products are constantly approaching children with sales messages that are distinguishable only by their brand."133 in the school food context, food service directors note that introducing a brand name food item has measur­ able success for inducing purchase, but when children did not recognize the brand name, it functions like a generic brand and then they focused on the actual qualities ofthe product, i.e., how good it tasted.134 little research on the use of other promotional techniques such as col­ ors or design is publicly available in the food context. it is clear that food companies use color to attract children, such as the case of heinz ez squirt ketchup, which came in colors such as green and purple. 135 reportedly, the 128. story & french, supra note 81, at 10. 129. atkin, supra note 93, at 44. 130. jd.at43. 131. john, supra note 1. 132. gwen b. achenreiner & deborah r. john, the meaning of brand names to chil­ dren: a developmental investigation, 13 j. consumer psychology 205, 207 (2003). 133. claude pecheux & christian derbaix, children and attitude toward the brand: a new measurement scale, j. advertising res., july-aug. 1999, at 19. 134. michael buzalka, this brand is your brand, this brand is 1\zy brand: how on­ site foodservice operators leverage the retail brand equity of major food manufacturers, 39 food mgmt. 24, 33 (2004). in the tobacco context, studies of australian and new zea­ land youths revealed that american branded tobacco packaging genemted positive imagery without additional promotional communications but generic packaging was considered unat­ tractive, not "cool," and undesimble to purchase or carry around. &e difranza et al., supra note 98, at 97 (citing paul c. beede & robert w. lawson, brand image attraction: the promotional impact of cigarette packaging, 18 n. z. fam. physician 175, 175 (1991)); centre for behavioral research in cancer, anti-cancer council of victoria, health warn­ ings and content labeling on tobacco products (1992) (adolescents' reactions to cigarette packs modified to increase extent and impact of health warnings); paul c. beede & robert w. lawson, the effect of plain packages on perception of cigarette health warnings, 106 public health 315,315 (1992). 135. bridges & briesch, supra note 11, at 163. 2012] government intervention in unhealthy food promotions 137 "stores couldn't keep the bottles stocked, so the company followed up with coloured ore-ida fries, and kraft macaroni & cheese also began to be of­ fered in colour."136 further, new innovative packaging designs are emerg­ ing that have not been studied. for example, a new technology was created to make illuminated cereal products, which are powered from the shelf and printed with inductive inks to make the package illuminate.137 another package designer created a package that can be used to play an interactive game using the box and a motion sensing technology, like nintendo wii. 138 c. summary in sum, the food retail environment does not support healthy choices and induces children to request and think they prefer unhealthy food be­ cause of the use of characters and other promotions on packaging and throughout the store. government regulation may be warranted to support public health and create healthy defaults in the retail environment. this is especially the case because the food retail environment is not being ad­ dressed by industry self-regulation and has been getting progressively worse from a public health perspective. n. regulating in-store and package promotions to protect children at the time of this writing, there are no federal, state, or local laws di­ rectly addressing the aspects of the retail environment set forth above. there are also no cases directly on point to determine how a court might consider them if challenged by food and beverage (collectively "food") re­ tailers or manufacturers. government entities considering adopting laws to address food packaging and retail promotions directed at children would want to avoid and succeed in any constitutional challenges brought by in­ dustry. to this end, analogies can be drawn from the case law related to other challenges for products or services deemed problematic. conceptually there are two types of regulations that could be ad136. ld. 137. sam grobart, c.e.s. 2011: diamonds in the rough, n.y. times (jan. 8, 2011), http://video.nytimes.com/video/20 11/0 l/08/business/l248069538616/ces20 11-diamonds-in­ the-rough.html (e.g., general mills; see video at 2:19 minutes). 138. press release, dassault systemes, reinventing packaging with interactive 3d and transform a box of cereal into a new generation game console, available at http://minimoys.3ds.com/presse/nestle3dvia (used by nestle; "player's movements are de­ tected in real time when tilting his cereal box. all children using wiimotes or any other motion sensor material understand very quickly the benefits of interaction between the body and th.e virtual world. the feeling of immersion is further enhanced by the screen image blending real and virtual. the player who seems himself like in a mirror, must collect balls of light to bring the character betameche out of the minimoys world (inside the package) onto the side of the box. this is a new step in the industry of promotions."). 138 indiana health law review [vol. 9:1 vanced to protect children and further public health. the first involves re­ stricting the marketing of certain products to children. the second would be to restrict the location within stores of certain products to create a health­ ier retail environment. both types would likely provoke challenge by the industry claiming that they implicate their first amendment rights of com­ mercial expression.139 however, legally they would be analyzed differently because the first would be viewed as restricting commercial speech, where­ as the second would be viewed as a regulation of conduct. the first amendment's protection for commercial speech is relevant when government attempts to restrict commercial communication intended to induce sales.140 food product labels are generally considered commercial speech protected by the first amendment. 141 in the context of product promotion, the case law primarily addresses restrictions on commercial speech for products only legally purchasable by adults (e.g., alcohol, tobac­ co ).142 even in instances when the government is attempting to protect children from communication about such products, the courts analyze the restrictions based on the rights of companies to communicate with adults and the concurrent right of adults to receive such speech.143 the supreme court has yet to analyze a commercial speech restriction aimed at protect­ ing children from communication directed at them about harmful products they can legally purchase.144 the regulation of conduct invokes a different line of jurisprudence and requires a differentiation between pure and expressive conduct; again, there are no cases directly on point.145 thus, analogies must be made in order to analyze how courts may respond to such regulations. in both contexts it may be appropriate for the government to empha139. see, e.g., commonwealth brands. inc. v. united states, 678 f. supp. 2d 512 (w.d. ky. 2010) (challenging congress' ban on the use of graphics and color on tobacco packaging under the first amendment) affirmed in part and reversed in part by discount tobacco city & lottery, inc. v. united states. nos. 10-5234 & 5235,2012 lexis 5614 (6th cir. march 19, 2012); philip morris usa, inc. v. city & county of s.f., 345 f. app'x 276 (9th cir. 2009) (challenging government's ban on the sale of tobacco in phannacies under the first amendment). 140. bd. oftrs. of the state univ. ofn.y. v. fox, 492 u.s. 469, 482 (1989) ("speech that proposes a commercial transaction"). see also city of cincinnati v. discovery network, inc., 507 u.s. 410,423 (1993) (defining commercial speech "even more narrowly, by char­ acterizing the proposal of a commercial transaction as 'the test for identifying commercial speech.'" (quoting bd. oftrs. of the state univ. ofn.y., 492 u.s. at 473-474.)). 141. see rubin v. coors brewing co., 514 u.s. 476, 481 (1995). 142. see, e.g., id.; lorillard tobacco co. v. reilly, 533 u.s. 525 (2001). 143. see, e.g., lorillard tobacco co., 533 u.s. at 525. 144. but see brown v. entm't merchs. ass'n, 131 s. ct. 2729 (2011) (striking down california law prohibiting the sale or rental of violent video games to/by minors under strict scrutiny test). none of the justices consid­ ered this a commercial speech case. 145. but see lorillard tobacco co. v. reilly, 533 u.s. 525 (2001) (applying the united states v. 0 'brien standard to ban on self-service displays of tobacco). 2012] government intervention in unhealthy food promotions 139 size its elevated interest in protecting children to promote public health. outside the speech context, the court has held that different constitutional protections and rights apply to children than to adults. 146 within the core speech context, the court recently devalued the government's role in pro­ tecting children from harmful core speech. 147 however, in the commercial context, the court has upheld restrictions to protect adults from overreach­ ing by commercial actors and supported federal agencies' function to enact guidelines to protect children. 148 a. government's role in the protection of children outside of the first amendment context, the supreme court has found that children have different rights than adults and that different standards apply to children. this is clear in the juvenile justice system, where the court found that minors' lack of maturity and vulnerability supports differ­ ent sentencing allowances for minors than adults.149 in the context of priva­ cy rights, the supreme court recognized three justifications for concluding that ''the constitutional rights of children cannot be equated with those of adults: the peculiar vulnerability of children; their inability to make critical decisions in an informed, mature manner; and the importance of the paren­ tal role in child rearing!'15° for example, children do not have rights on par with adults to express themselves in school, 151 to purchase obscene materi­ als, 152 to marry, or to vote.153 however, this appreciation has not translated 146. seee.g.,roperv. simmons, 543 u.s. 551 (2005). 147. brown v. entm't merchs. ass'n, 131 s. ct. 2729 (2011). 148. see part iv .a., infra. 149. in perhaps the most vital area where this has been found, the court held that ado­ lescents and adults cannot be treated the same in the criminal justice system due to the inher­ ent differences in the minds of youths. roper v. simmons, 543 u.s. 551,578 (2005). in the context of juvenile offenders, the supreme court recognized three significant differences between minors under eighteen and adults supported by scientific and sociological studies, including: (1) a "lack of maturity and an underdeveloped sense of responsibility'' that "often result in impetuous and ill-considered actions and decisions;" (2) being '<vulnerable or sus­ ceptible to negative influences and outside pressures, including peer pressure," resulting in or due to "less control, or less experience with control, over their own environment"; and (3) the fact that "the character of a juvenile is not as well formed as that of an adult the per­ sonality traits of juveniles are more transitory, less fixed." id at 569-70. see also graham v. florida, 130 s. ct 2011 (2010) (holding the eighth amendment's cruel and unusual punishments clause does not permit a juvenile offender to be sentenced to life in prison without parole for a nonhomicide crime, in part due to the factors recognized in roper v. simmons). 150. bellotti v. baird, 443 u.s. 622.634 (1979). 151. hazelwood sch. dist. v. kuhlmeier, 484 u.s. 260, 272 (1988). 152. ginsberg v. new york. 390 u.s. 629.639-40 (1968). 153. !d. at 649--650 (stewart, j., concurring) ("[a] child-like someone in a captive audience-is not possessed of that full capacity for individual choice which is the presuppo­ sition of first amendment guarantees. it is only upon such a premise. i should suppose, that a state may deprive children of other rights-the right to many, for example. or the right to vote-deprivations that would be constitutionally intolerable for adults."). 140 indiana health law review [vol. 9:1 into the supreme court supporting wide government protections for chil­ dren against potentially harmful core speech. in the area of core expression, the court upheld a restriction on inde­ cent expletives directed at a general audience· (children and adults) on the radio.154 since that 1978 case, the federal communications commission ("fcc") has functioned under the theory that it can restrict indecent exple­ tives on broadcast media; however, the supreme court accepted certiori in a television case to resolve the question of whether the fcc's "current inde­ cency-enforcement regime violates the first or fifth amendment to the united states constitution."155 it is unclear if the court will reverse direc­ tion on this topic. either way, the court commonly strikes down speech restrictions to protect the interests of adults in receiving the speech and the right of the speaker to reach adults.156 historically, the court has upheld restrictions to protect children from obscenity, which is speech depicting "sexual conduct."157 the seminal case on the topic is ginsberg v. new york, where the supreme court sustained a 154. fcc v. pacifica found., 438 u.s. 726, 750-51 (1978). 155. fcc v. fox television stations, inc., 131 s. ct. 3065, 3065 (2011), from fox television stations, inc. v. fcc, 613 f.3d 317 (2d cir. 2010) (vacating the fcc's indecency policy under the first amendment). see also fcc v. fox television stations, inc., 129 s. ct. 1800, 1813 (2009) (this was not a first amendment case but a review of agency authori­ ty to regulate; the court accepted the argument that, "children mimic the behavior they ob­ serve-or at least the behavior that is presented to ~em as normal and appropriate."). it is unclear whether this rationale could hold outside the context of indecent language, but one could argue that repeating unhealthy eating behavior is more harmful than repeating "one­ word indecent expletives." id 156. in catchy but ultimately inconsequential dicta, the court differentiated between adults and children in the context of attorney advertising to reject governmental paternalism for adults by stating: "we reject the paternalistic assumption that the recipients of petition­ er's letterhead are no more discriminating than the audience for children's television." peel v. att'y registration & disciplinary comm'n, 496 u.s. 91, 105 (1990). see also ass'n of nat'l advertisers v. lungren, 44 f.3d 726, 734 (9th cir. 1994). the latter audience is who the food companies are targeting on packaging and in stores. perhaps a court would be swayed by the inverse reference that the audience for children's cartoons warrant paternal­ istic protection precisely because they are not discriminating or knowledgeable about the commercial marketplace. 157. brown v. entm't merchs. ass'n, 131 s. ct 2729 (2011 ). see, e.g., ginsberg, 390 u.s. at 636 (upholding a state law restricting minors' access to sexually explicit material "[b]ecause of the state's exigent interest in preventing distribution to children of objectiona­ ble material, it can exercise its power to protect the health, safety, welfare and morals of its community by barring the distribution to children of books recognized to be suitable for adults."); united states v. am. library ass'n, inc., 539 u.s. 194, 215 (2003) (kennedy, j., concurring) ("the interest in protecting young library users from material inappropriate for minors is legitimate, and even compelling."); denver area educ. telecomm. consortium, inc. v. fcc, 518 u.s. 727, 743 (1996) ("[t]he provision before us comes accompanied with an extremely important justification, one that this court has often found compelling-the need to protect children from exposure to patently offensive sex-related material."); sable commc'ns of cal., inc. v. fcc, 492 u.s. 115, 126 (1989) ("[a] compelling interest in pro­ tecting the physical and psychological well-being of minors ..... extends to shielding mi­ nors from the influence ofliterature that is not obscene by adult standards."). 20 12] government intervention in unhealthy food promotions 141 state ban on the sale of "girlie" magazines to minors under seventeen. 158 the court upheld the law and found that parents "are entitled to the support of laws" to aid them in their "claim to authority in their own household to direct the rearing of their children."159 in what seems to be a departure from the rationale in ginsberg, the supreme court most recently struck down a state law prohibiting minors from buying or renting violent video games in brown v. entertainment merchants association.160 the court considered the ban to be an unconsti­ tutional restriction on core speech {akin to literary and artistic expression) and rejected the similarities between this law and that upheld in ginsberg as sufficient to uphold the video game ban. 161 the court sought to distinguish between the two laws by pointing to the lack of "a longstanding tradition in this country of specially restricting children's access to depictions of vio­ lence," presumably in contrast to obscenity.162 the court gave lip service to the state's legitimate interests in "helping concerned parents control their children."163 however, it found the law "seriously underinclusive" because it "permits a parental or avuncular veto."164 oddly, the court had consid­ ered this aspect of the law in ginsberg pivotal in its constitutionality.165 the brown court similarly found the law to be "seriously overinclusive because it abridges the first amendment rights of young people whose par­ ents {and aunts and uncles) think violent video games are a harmless pas­ time."166 the extent the government can protect children from offensive core speech is unclear. the brown court diverged from the unqualified declara­ tion in ginsberg that the "well-being of its children is of course a subject 158. ginsberg, 390 u.s. at 643. 159. id at 639. see also bellotti v. baird, 443 u.s. 622, 634 (1979) (protecting par­ ents' role in childrearing); fcc v. pacifica found., 438 u.s. 726, 749 (1978) (quoting gins­ berg, 390 u.s. at 639-40 (supporting "'parents' claim to authority in their own household'"). 160. brown, 131 s. ct. at 2742 161. !d. at 2735. california modeled its statute after the law upheld in ginsberg. !d. the majority found california could not show a "direct causal link between violent video games and harm to minors." id. at 2738. justice breyer, dissenting, came to the opposite conclusion. !d. at 2770. justice thomas' dissent found that the majority decision "does not comport with the original public understanding of the first amendment" based on his con­ clusion that the "practices and beliefs of the founding generation establish that 'the freedom of speech,' as originally understood, does not include a right to speak to minors (or a right of minors to access speech) without going through the minors' parents or guardians." id. at 2751 (quoting another source). 162. !d. at 2736. 163. brown v. entm't merchs. ass'n, 131 s. ct. 2729,2741 (2011). 164. !d. at 2742. 165. reno v. aclu, 521 u.s. 844, 865 (1997) (quoting ginsberg, 390 u.s. at 639) (distinguishing the law it struck down from the law upheld in ginsberg because "the prohibi­ tion in ginsberg against sales to minors d[id] not bar parents who so desire[d] from purchas­ ing the magazines for their children," among other aspects including the fact that the new york statute only applied to commercial transactions). 166. brown, 131 s. ct. at 2742. 142 indiana health law review [vol. 9:1 within the state's constitutional power to regulate."167 although the brown majority relied on the historical disapproval of depictions of sexual conduct as a rationale for differentiating between obscenity and violence, it does not seem to be sufficient to justify the recent holding. violent video games have depictions more likely to "corrupt the young or harm their moral de­ velopment" than those at issue in ginsberg.168 by playing the video games children are exposed to sexual depictions, where they can "rape a mother and her daughters" and "rape native american women." in addition the children are able to "reenact the killings carried out by the perpetrators of the murders at columbine high school and virginia tech," and "engage in 'ethnic cleansing' and can choose to gun down african-americans, latinos, or jews."169 the rationale is flawed, and it is now unclear whether the court would have upheld the law at issue in ginsberg if it was presented with such a challenge today. the best way to reconcile this outcome is to take the court at its word that it considered violent video games akin to vio­ lent literature (like grimm's fairy tales),170 and children have the equal right to access books as adults. in the commercial context, the supreme court has sanctioned gov­ ernment restrictions on "forms of aggressive sales practices that have the potential to exert 'undue influence' over consumers."171 this occurs most frequently in the context of attorney advertising. 172 attorney advertising generally has been subject to different standards than advertising for other products and services, 173 but the same underlying concern-protection of persons who are not in the position to protect themselves-is present in the 167. ginsberg, 390 u.s. at 639. 168. brown, 131 s. ct. at 2742 (discussing california's interest in passing the statute). 169. id. at 2749-50 (alito, j., concurring). 170. id. at 2736. 171. 44 liquormart v. rhode island, 517 u.s. 484,498 (1996) (citing bates v. state bar of ariz., 433 u.s. 350, 366 (1977)). "when a state regulates commercial messages to protect consumers from misleading, deceptive, or aggressive sales practices, or requires the disclosure of beneficial consumer information, the purpose of its regulation is consistent with the reasons for according constitutional protection to commercial speech." id at 501. see also, paris adult theater v. slaton, 413 u.s. 49, 64 (1973) ("[securities regulations]are to protect the weak, the uninformed, the unsuspecting, and the gullible from the exercise of their own volition."); cincinnati v. discovery network, 507 u.s. 410, 433 (1993) (blackmun j., concurring) ("[consumers have] little interest in being coerced into a purchas­ ing decision.") (citing ohralik v. ohio state bar ass'n., 436 u.s. 447,457 (1978)). 172. bates v. state bar of ariz., 433 u.s. 350, 366 (1977); see also, fla. bar v. pape, 918 so. 2d. 240,242 (fla. 2005). 173. see, e.g., in repetition of felmeister & isaacs, 104 n.j. 515, 536 (n.j. 1986) ("we do not believe that the constitution requires that the rules governing attorney advertis­ ing be the same as those applicable to beer, automobiles, or casino hotels."); cf zauderer v. office of disciplinary counsel of the sup. ct. of ohio, 471 u.s. 626, 677 (1985) (o'connor, j., concurring in part, concurring in the judgment in part, and dissenting in part) ("the court's commercial speech decisions have repeatedly acknowledged that the differences between professional service and other advertised products may justify distinctive state regu­ lation."). 20 12] government intervention in unhealthy food promotions 143 context of marketing directed at children for products that are not healthy for them. analogies can be drawn when considering protections for chil­ dren against overreaching by commercial actors. in the attorney advertising context, the supreme court has upheld re­ strictions on commercial speech to protect adult consumers from overreach­ ing. the court upheld the state's ability to ban in-person solicitations by lawyers, ''trained in the art of persuasion," of ''vulnerable" accident vic­ tims.174 based on this precedent, the court also upheld a thirty-day re­ striction on targeted direct mail solicitations of accident victims. 175 outside the attorney advertising context, the court agreed that the government's interest in protecting college students from commercial exploitation was substantial.176 and, the court found that athletic recruitment letters mailed to middle school children were a .. hard-sell" tactic and potentially ex­ ploitive. 177 although not yet applied to children in the commercial speech con­ text, this recognition of the state's interest in protecting vulnerable persons from commercial exploitation is particularly important. children are not independent and rational consumers178 who make informed and reliable de­ cisions.179 children have an undeveloped notion of commercial transac­ tions. young children cannot differentiate between commercial and factual speech and do not understand marketing's intent is to get them to desire a product!80 it is not until early adolescence that youth even perceive the full range of connections among products, price, and value.181 governments seeking to protect children from commercial communi­ cations for unhealthy products may want to align its interests with that of the attorney advertising cases. this line of cases supports the rationale that the government can protect vulnerable population from undue commercial 174. ohralik v. ohio state bar ass'n, 436 u.s. 447, 465 (1978); but see edenfield v. fane, 507 u.s. 761 (1993) (declining to extend the holding of ohralik beyond the attorney context to accountants). 175. fla. bar v. went for it, inc., 515 u.s. 618, 635 (1995); see also alexander v. cahill, 598 f.3d 79, 100 (2d cir. 2010). cert. denied, 2010 u.s. lexis 9812 (dec. 13, 2010). 176. bd. oftrs. of state univ. ofn.y. v. fox, 492 u.s. 469,475 (1989). 177. tenn. secondarysch. v. brentwoodacad., 551 u.s. 291, 300(2007). 178. robert post, the constitutional status of commercial speech, 48 ucla l. rev. 1, 41 (2000). 179. ginsberg v. new york. 390 u.s. 629, 636--637 (1968) ("[w]e inquire whether it was constitutionally impermissible for new york, . . . to accord minors under 17 a more restricted right than that assured to adults to judge and determine for themselves what sex material they may read or see. we conclude that we cannot say that the statute invades the area of freedom of expression constitutionally secured to minors. j. 180. soontae an & susannah stem, mitigating the effects of advergames on children, 40 j. of advertising 43,43 (2011) ("results showed that none of the ad breaks helped chil­ dren to clearly detect the commercial nature of the game. also, the presence of the ad break was not linked to children's correct identification of the persuasive agent.j. 181. john, supra note l,at 196. 144 indiana health law review [vol. 9:1 influence. note that the courts have supported the government's interest in pro­ tecting children from the advertisement of products deemed harmful even when children are not the ultimate purchasers of the products. this has oc­ curred in ftc cases for tobacco182 and cereal products183 where the ultimate purchaser is not necessarily the child but the advertising was considered deceptive as to them. b. regulating the food retail environment based on the research outlined above, two areas emerge of particular concern: (1) the use oflicensed characters and spokescharacters on packag­ ing to influence children's request, enjoyment and perceived taste of food products, and (2) tactical placement of unhealthy products in unavoidable locations of a retail environment creating unhealthy defaults and fostering purchase requests by children. there are several options the government could consider to address packaging and the food retail environment to pro­ tect children's health: restrict the use of characters on all products intended for children as deceptive and misleading to them, restrict the use of charac­ ters on products for children that do not meet nutrition guidelines as a commercial speech restriction, or regulate the location of all such products within the retail establishment, according to nutritional guidelines and the use of a character. ·the restriction on the use of a character on packaging implicates commercial speech and the regulation ofthe location of products targets conduct within the retail environment. any regulation could provoke legal challenges by industry; however, there is a constitutional difference between regulating commercial speech and conduct. 184 truthful, non-deceptive labeling, marketing, and advertis­ ing are generally considered commercial speech, protected by the first amendment.185 government restrictions on commercial speech are subject 182. complaint at 1, in the matter of r.j. reynolds tobacco co., no. 9285 (may 28, 1997), available at http://www.ftc.gov/os/1997/05/d9285cmp.htm (con­ firming the perspective that the government has the authority to protect children from products even though they are not the ultimate purchaser of the product­ because they are legally unable to purchase tobacco products). 183. itt continental baking co. inc. v. ffc, 532 f.2d 207, 219 (2d cir. 1976); kel­ logg co., 99 f.t.c. 8, (1982); cf. louise a. heslop & adrian b. ryans, a second look at children and the advertising of premiums, 6 j. of consumer research, 414, 414 {"chil­ dren, especially very young ones, do not generally purchase products on their own. especial­ ly when shopping for 'nontreat' items, their preferences are expressed to a parent who screens their requests."). 184. sorrell v. ims health inc., 131 s. ct. 2653, 2664 (2011) ("it is true that re­ strictions on protected expression are distinct from restrictions on economic activity or, more generally, on nonexpressive conduct. it is also true that the first amendment does not pre­ vent restrictions directed at commerce or conduct from imposing incidental burdens on speech."). 185. rubin v. coors brewing co., 514 u.s. 476, 482 (1995); see lorillard tobacco 2012] government intervention in unhealthy food promotions 145 to scrutiny under the intermediate test developed in the case, central hud­ son v. public service commission of new york. 186 conversely, the first amendment is not implicated when the government regulates pure con­ duct.187 in between pure conduct and speech is expressive conduct, which is conduct that has an expressive component. 188 the court has "assume[ dr' that displaying products in the manner a retailer desires can be considered expressive conduct. 189 restrictions on expressive conduct are analyzed un­ der the test created in the case of united states v. 0 'brien, and later applied to commercial expression in lorillard tobacco co. v. reilly.190 different levels of government are more appropriate to address these diverse aspects of the food environment. the fda has regulatory authority over the labels on food and beverage products.191 the fda is in the best position legally192 and practically to address the use of characters on prod­ ucts sold in interstate commerce.193 conversely, the retail environment is more appropriately within the jurisdiction of state and local governments. states and locales have individual statutes on health codes, building inspec­ tions, and similar topics that can be used to enact further regulations. states and locales can enact zoning ordinances, conditional licensing, and condi­ tional use permits to effectuate change in the retail environment. the following legal analysis of methods to address the food retail en­ vironment is based on this division of jurisdiction over the topics. thus, the fda (or congress) is best equipped to address food packaging, and thus commercial speech, and states and locales are best equipped to address the retail environment, and thus conduct. the legal analysis below attempts to flush out some of the arguments on both sides to determine which regula­ tions would be most effective and legally defensible. v. foodandbeveragepackaging in order to address promotional practices directed at children on food packaging, the fda could consider several options to address the use of co. v. reilly, 533 u.s. 525 (2001). 186. cent. hudson gas & elec. corp. v. pub. service comm'n ofn.y., 447 u.s. 557, 564 (1980). 187. spence v. wash., 418 u.s. 405,409 (1974) (discussing that activity must be "suf­ ficiently imbued with elements of communication to fall within the scope of the first . . . amendment[]."). 188. united states v. o'brien, 391 u.s. 367, 376 (1968) (distinguishing between con­ duct that expresses an idea and conduct that does not). 189. lorillard tobacco co., 533 u.s. at 529. 190. see lorillard tobacco co. v. reilly, 533 u.s. 525 (2001); united states v. o'brien, 391 u.s. 367 (1968). 191. see 21 u.s.c. § 343 (2010). 192. see 21 u.s.c. § 343-1(ax2) (2010). 193. in 2010 the agency began an initiative to address front of package nutrition label­ ing icons directed at adults, but it bas yet to address packaging promotions directed at chil­ dren. see notices, 75 fed. reg. 22602-01 (apr. 29, 2010). 146 indiana health law review [vol. 9:1 characters on packaging. in rubin v. coors brewing co., the supreme court confirmed that truthful information on beer labels is considered commercial speech, 194 and in zauderer v. office of disciplinary counsel, the court found that "illustrations" on advertising directed at adults are pro­ tected to the same extent as other forms of commercial speech; restrictions on such are subject to scrutiny under the central hudson test.195 although a court might strike down a prohibition on the use of images on food prod­ ucts for the general population, the case could be different for food products directed at and marketed to children. the following briefly reviews first amendment jurisprudence related to restricting commercial speech and ap­ plies this intermediate test to a proposed restriction on the use of characters on packaging for food not meeting nutritional guidelines. a. central hudson overview courts analyze commercial speech restrictions under the central hud­ son test, 196 which asks whether: (1) the expression is protected by the first amendment, meaning that it must relate to a lawful activity and not be false, deceptive, or misleading; (2) the government asserted a substantial interest to be achieved by restricting commercial speech; (3) the regulation directly advances this interest; and (4) the restriction is not more extensive than necessary to serve this interest.197 the first inquiry under the central hudson test asks whether the speech in question is protected by the first amendment, and thus, not false, deceptive or misleading.198 the first amendment does not protect such 194. rubin v. coors brewing co., 514 u.s. 476, 481 (1995); see also bad frog brew­ ery, inc. v. n.y. state liquor auth., 134 f.3d 87,96-97 (2d cir. 1998). 195. zauderer v. office of disciplinary counsel of the sup. ct. of ohio, 471 u.s. 626, 647 (1985). 196. rubin v. coors brewing co., 514 u.s. 476,481-82 (1995); lorillard tobacco co. v. reilly, 533 u.s. 525 (2001) (showing industry seeks strict scrutiny over government re­ strictions of commercial speech; however, to date the supreme court has applied this inter­ mediate test although some justices disagree). see id. at 554-555 ("petitioners urge us to reject the central hudson analysis and apply strict scrutiny. they are not the first litigants to do so. admittedly, several members of the court have expressed doubts about the cen­ tral hudson analysis and whether it should apply in particular cases. but here, as in greater new orleans, we see 'no need to break new ground. central hudson, as applied in our more recent commercial speech cases, provides an adequate basis for decision."' (citations omit­ ted)). 197. cent. hudson gas & elec. corp. v. public serv. comm'n ofn.y., 447 u.s. 557, 564(1980). 198. this section focuses on misleading and deceptive advertising but it is important to recognize that speech related to an unlawful activity is not protected by the first amend­ ment. the government may regulate or entirely ban speech proposing an illegal transaction. viii. ofhoffinan estates v. the flipside, 455 u.s. 489,496 (1982) (citing cent. hudson gas & elec. corp., 447 u.s. at 563-564); pittsburgh press co. v. human relations comm'n, 413 u.s. 376, 388 (1973)). therefore, if the government made it illegal for children to purchase certain items, such as soft drinks, the government could also ban speech directed at children 2012] government intervention in unhealthy food promotions 147 speech and "[t]he government may ban forms of communication more like­ ly to deceive the public than to inform it."199 the supreme court uses the terms misleading and deceptive interchangeably and has differentiated among three different categories of misleading speech: inherently, proven in fact, and potentially?00 the government can ban or otherwise restrict speech found to be misleading in fact or inherently misleading, but it can only require increased information disclosures or rewording of the speech if it is found to be potentially misleading; any further restriction on the latter is subject to review under the remaining three prongs of central hudson. 201 the inherently misleading category of speech stems from the 1979 case of friedman v. rogers, where the court analyzed an optometrist's challenge to a state law that prohibited the practice of optometry under an assumed, trade, or corporate name as a violation of his first amendment rights. 202 the court held that the use of trade names is a form of commer­ cial speech but found that because they have "no intrinsic meaning," they can cause deception. 203 although this case was decided prior to central hudson, it is the basis for the inherently misleading category of speech and a viable rationale to find speech to be unprotected under the first prong of central hudson. lower courts tend to only apply the inherently misleading standard when the possibility of deception is "self-evident" 204 or the facts are similar to proposing that transaction. similarly, if the government prohibited promotional toy­ giveaways in food boxes or with fast-food meals, then the marketing of the same could be prohibited. 199. cent. hudson gas & elec. corp., 447 u.s. at 563 (citing friedman v. rogers, 440 u.s. l, 15-16 (1979)). 200. in re r. m. 1., 455 u.s. 191, 203 (1982) ("[w]hen the particular content or method of the advertising suggests that it is inherently misleading or when expe­ rience has proved that in fact such advertising is subject to abuse, the states may impose appropriate restrictions. misleading advertising may be prohibited entirely. but the states may not place an absolute prohibition on certain types of potentially misleading information ... if the information also may be presented in a way that is not deceptive. thus, ... the remedy in the first instance is not necessarily a prohibition but preferably a requirement of disclaimers or explanation."). 201. !d. 202. friedman v. rogers, 440 u.s. 1, 4 (1979). 203. ld at 11-14 ("a trade name conveys no information about the price and nature of the services offered by an optometrist until it acquires meaning over a period of time by associations formed in the minds of the public between the name and some standard of price or quality. because these ill-defined associations of trade names with price and quality in­ formation can be manipulated by the users of trade names, there is a significant possibility that trade names will be used to mislead the public."). 204. n.c. state bar v. culbertson, 627 s.e.2d 644, 648 (n.c. ct. app. 2006) (where an attorney advertised that he was "published" in the federal law reports, which are the official publications of court of appeals and contain court opinions and other court docu­ ments, the court found "the possibility of public deception is self-evident," and thus the de­ fendant's statements were "inherently misleading."); cf zauderer v. office of disciplinary counsel, 471 u.s. 626, 652-53 (1985) ("when the possibility of deception is as self-evident as it is in this case, we need not require the state to 'conduct a survey of the ... public be­ fore it [may] determine that the [advertisement] has a tendency to mislead."' (quoting fed. trade comm'n v. colgate-palmolive co., 380 u.s. 374, 391 (1965)); see also bronco wine 148 indiana health law review [vol. 9:1 that of friedman; i.e., when they find a word to have no intrinsic meaning (for example the word "invoice" in automobile advertising).205 conversely, evidence is necessary for the government to show that speech is actually, or proven in fact to be misleading.206 when "experience has proved that in fact such advertising is subject to abuse, the states may impose appropriate ·restrictions."207 lower courts consistently agree that speech is '"actually misleading' only where the record contains actual evi­ dence of deception. "208 potentially misleading speech is by definition speech that can be pre­ sented in a way that is not deceptive, so courts require such speech to be revised accordingly or allow the government to require disclosures or dis­ claimers to correct any potential misunderstanding. 209 thus, the govern­ ment can only require more speech in this context because potentially misleading speech is protected by the first amendment (unlike inherently and actually misleading speech).210 if a court finds the commercial speech to be truthful and not mislead­ ing or deceptive, it applies the remaining three prongs of the central hud­ son test to the speech restriction. under prong two, courts ask whether the regulation furthers a substantial government interest. 211 courts examine the government's rationale for passing the law to determine whether the gov­ ernment's interest is "substantial" and the problem the law seeks to address is real.212 in the past, the court has recognized that the government has a co. v. jolly, 29 cal. rptr. 3d 462,471-481 (cal. ct. app. 2005) (finding of inherently mis­ leading when company .sought to use a geographic designation in its brand name that did not accurately reflect the origin of its products). 205. joe conte toyota v. la. motor vehicle comm'n, 24 f.3d 754, 757 (5th cir. 1994) (citing barry v. arrow pontiac, inc., 494 a.2d 804 (n.j. 1985); see also adams ford belton, inc. v. mo. motor vehicle comm'n, 946 s.w.2d 199 (mo. 1997) (relying on joe conte toyota to find the term "invoice" to be inherently misleading). 206. peel v. att'y registration & disciplinary comm'n oflll., 496 u.s. 91, 106 (1990) (rejecting the contention that the attorney's letterhead was "actually misleading," given "the complete absence of any evidence of deception in the present case."). 207. in re r. m. j., 455 u.s. 191,203 (1982). 208. piazza's seafood world, llc v. odom, 2004 u.s. dist. lexis 25991, at *13 (e.d. la. dec. 22, 2004) (quoting joe conte toyota, inc. v. la. motor vehicle comm'n, 24 f.3d 754, 756 (5th cir. 1994) (citing peel v. att'y registration & disciplinary comm'n of ill., 496 u.s. 91, 106 (1990)); see also snell v. engineered systems & designs, 669 a.2d 13, 21-22 (del. 1995) (finding evidence presented did not support position that the commercial speech was misleading in fact because, although survey evidence could have been persua­ sive, the survey presented was outdated, from a very different geographic location, and did not ask about the actual words being contested). 209. in re r. m. j., 455 u.s. at 203; see am. acad. of pain mgmt. v. joseph, 353 f.3d 1099, 1107 (9th cir. 2004); see also peel v. att'y registration & disciplinary comm'n of ill., 496 u.s. 91, 109 (1990). without evidence of deception, courts struggle between the inherently and potentially misleading categories, often opting for the latter. 210. in re r. m. j., 455 u.s. at 203. 211. cent. hudson gas & elec. corp. v. public serv. comm'n ofn.y., 447 u.s. 557, 564(1980). 212. edenfield v. fane, 507 u.s. 761, 768 (1993) ("[w]e must identify with care the interests the state itself asserts. unlike rational basis review, the central hudson standard 20 12] government intervention in unhealthy food promotions 149 substantial interest in promoting and protecting the public health, safety, and welfare213 and "preventing commercial exploitation" of young adults.214 the third step of central hudson requires that the state demonstrate that its commercial speech restriction "directly and materially advances the asserted governmental interest."215 while the court once accepted less, it now requires the government to provide empirical evidence to support its position that the commercial speech restriction will alleviate the harms ar­ ticulated by the government to a material degree.216 in lorillard tobacco co. v. reilly the government successfully passed the third prong by proffer­ ing several strong studies conducted by the fda, surgeon general, and the iom.217 based on this record, the court found that the state ''provided am­ ple documentation of the problem with underage [tobacco] use" to "justify" the regulation.218 does not permit us to supplant the precise interests put forward by the state with other sup­ positions. neither will we turn away if it appears that the stated interests are not the actual interests served by the restriction.") (citation omitted). see also sciarrino v. city of .j{ey west, fla., 83 f.3d 364, 367 (11th cir. 1996) ("to find a 'substantial interest,' a court must conclude both that the interest advanced by the state is legitimate in theory, and that that interest is in remedying a problem that exists in fact (or probably would exist, but for the challenged legislation."). 213. see, e.g., rubin v. coors brewing co., 514 u.s. 476, 485 (1995) (finding the government has a significant interest in protecting the health, safety, and welfare of its citi­ zens); see also fla. bar v. went for it inc., 515 u.s. 618, 625 (1995) ("'states have a com­ pelling interest in the practice of professions within their boundaries, and ... as part of their power to protect the public health, safety, and other valid interests they have broad power to establish standards for licensing practitioners and regulating the practice of professions."') (quoting goldfarb v. va. state bar, 421 u.s. 773, 792 (1975)); see also sorrell v. ims health inc., 131 s. ct. 2653, 2682 (2011) (breyer, j. dissenting) ("the protection of public health falls within the traditional scope of a state's police powers."). 214. bd. oftrs. of state univ. ofn.y. v. fox, 492 u.s. 469,475 (1989). 215. greater new orleans broad. ass'n, inc. v. united states, 527 u.s. 173, 188 (1999). 216. fla. bar v. went for it, inc., 515 u.s. 618, 628 (1995) ("in any event, we do not read our case law to require that empirical data come to us accompanied by a surfeit of background information."). it is noteworthy that such a statement was made in the context of an attorney advertising case, which for all intents and purposes is its own line of first amendment jurisprudence. however, the court has since changed its tune in commercial speech cases. see, e.g., 44 liquormart, inc. v. rhode island, 517 u.s. 484, 506 (1996) (stat­ ing that it would not rely on "speculation or conjecture" to uphold a restriction on commer­ cial speech) (quoting edenfield v. fane, 507 u.s. 761, 770 (1993)). the court has since rejected this view and now requires evidence that the regulation will alleviate the harm the government seeks to rectify to a material degree. see lorillard tobacco co. v. reilly, 533 u.s. 525, 558 (2001) (studies and reports relied on by massachusetts were conducted by federal agencies, the surgeon general and the nationally recognized institute of medicine.). see also thompson v. w. states med. ctr., 535 u.s. 357 (2002). in the rare instances where the court appears to require less evidence to support the link between the speech restriction and the harm, the court seems to do this only because it finds that the regulation clearly fails under the fourth prong. 217. lorillard tobacco co., 533 u.s. at 558. 218. /d. at 561. the government sometimes faces difficulty under prong three when the court is faced with a regulatory scheme that includes a commercial speech restriction. if the government includes exceptions to the regulatory scheme that are legitimate from a regu­ latory perspective, and would seem to assist in the fit under prong four (that the restriction is 150 indiana health law review [vol. 9:1 part four of the central hudson test asks whether the restriction is "no more extensive than necessary to further the state's interest:'219 in other words, the court considers whether the regulation suppresses more speech than necessary to address the purported harm at which it is aimed.22° for example, in lorillard tobacco co. v. reilly, the state attempted to restrict outdoor billboards within 1,000 feet of schools or playgrounds, and the court found this indicated a lack of tailoring because in some major urban areas it would result in a near-complete ban on billboard communication to adults.221 restrictions are also more extensive than necessary if they in­ trude on adults' rights to access the speech in an effort to protect chil­ dren.222 no more extensive than necessary to further the state's interest) this can cause it to fail under prong three if it does not also advance the speech restriction. for example, in greater new orleans broad. ass 'n v. united states, the court struck down a statute prohibiting broadcast advertisements for gambling at private casino because the regulation exempted tribal casi­ nos, which the court found undermined the government's stated purpose to reduce the social costs associated with gambling. greater new orleans broad. ass'n, 527 u.s. at 191-92. conversely, the court may find that the regulatory regime alone would have satisfied the government's interests without the speech restriction. in thompson v. w. states med. ctr., the court struck down a commercial speech restriction that was part of a broader regulatory regime, because the majority found the rest of the regime alone was sufficient to further the government's interest. thompson, 535 u.s. at 357. however, the four dissenting justices found the speech restriction was necessary to fulfill the purpose of the consumer protection regulation. /d. at 385-86 (breyer, j., dissenting joined by rehnquist, c.j., stevens, j., gins­ burg, j.) (finding the alternatives suggested by the court not enough without the commercial speech restriction to rectify the safety problems the government sought to address). there is a lack of clarity in applying the central hudson test and this often appears in prongs three and four. 219. cent. hudson gas & electric corp. v. pub. serv. comm'n ofn.y., 447 u.s. 557, 569-70 (1980). 220. one difficulty for the government in part four is to properly address the speech in question but not more extensively than necessary. the speech restrictions struck down in lorillard tobacco co. v. reilly exemplify this point. if the regulation is broad enough. to be effective (e.g., the 1,000 foot rule) it can be found to be too broad and lack tailoring, but if it is narrowly tailored to address one aspect of the problem (e.g., a ban on tobacco ads under five feet high in retail establishments) it can be found to be ineffective. lorillard tobacco co. v. reilly, 533 u.s. 525,562,566 (2001). 221. lorillard tobacco. co., 533 u.s. at 564 (striking the tobacco advertising re­ strictions and explaining that "the governmental interest in protecting children from harmful materials . ·. . does not justify an unnecessarily broad suppression of speech addressed to adults") (quoting reno v. am. civil liberties union, 521 u.s. 844, 875 (1997)). 222. see, e.g., butler v. michigan, 352 u.s. 380, 384 (1957) (invalidating a michigan statute that made it a crime to sell to the general public literature that was inappropriate for minors) (explanation from frankfurter, j.) ("the incidence of this enactment is to reduce the adult population of michigan to reading only what is fit for children . . . . surely, this is to bum the house to roast the pig."); see also bolger v. youngs drug prods. corp., 463 u.s. 60, 73, 75 (1983) ("the level of discourse reaching a mailbox simply cannot be limited to that which would be suitable for a sandbox .... [t]he justifications offered by the government are insufficient to warrant the sweeping prohibition on the mailing of unsolicited contracep­ tive advertisements."}; sable comm'ns of cal., inc. v. fcc, 492 u.s. 115 (1989) (invalidat­ ing the ~ommunications act "dial-a-porn" provision that denied adult access to telephone messages which were indecent but not obscene because it far exceeded that which was nec­ essary to limit access of minors to such messages. the court notes that it was technological­ ly possible to prevent minors from accessing the calls while still permitting adult access). 2012] government intervention in unhealthy food promotions 151 under prong four, the court also considers whether the regulating body considered alternative regulations that do not implicate speech.223 the court is particularly likely to strike down a speech restriction under prong four when non-speech-related means of accomplishing the government's objective exist.224 in rubin v. coors brewing co., the court invalidated a law prohibiting beer labels from displaying alcohol content, basing its rul­ ing in part, on the existence of several alternatives that did not impinge on speech, such as directly limiting the alcohol content ofbeer.225 it is unclear how effective the alternatives must be in comparison to the challenged regulation.226 in 44 liquormart, inc. v. rhode island, the court considered a statute prohibiting advertisement of liquor prices, and the plurality opinion found that the regulation failed prong four because "alternative forms of regulation that would not involve any restriction on speech would be more likely to achieve the state's goal of promoting tem­ perance."227 however, in sorrell v. ims health inc., the majority struck down a statute as unconstitutionally restricting commercial speech despite the dissenting justices conclusion that no "equally effective 'more limited' restriction" was proffered or would be adequate as an alternative to the state's law.228 similarly, in thompson v. w states med. ctr., the majority struck down the speech restriction based on the availability of alternative regulations, but the dissenting justices found that the alternatives did not address the problem the government sought to rectify. and the commercial speech restriction was necessary to effectively protect the safety of consum­ ers.229 the conclusion one can draw is that the supreme court will look to whether the government considered alternatives to restricting speech in or223. see, e.g., greater new orleans broad. ass'n v. united states, 527 u.s. 173, 17680 (1999). the government attempted to prohibit television or radio broadcasts of lottery and casino-gambling advertisements. the court recognized that the regulation did not need to be the least restrictive available, but it found that the regulation "permit[ ed} a variety of speech that poses the same risks the government purports to fear, while banning messages unlikely to cause any harm at all" failing part four. id. at 195. 224. see, e.g., thompson v. w. states med. ctr., 535 u.s. 357, 372-73 (2002). 225. rubin v. coors brewing co., 514 u.s. 476,490-91 (1995). 226. thompson, 535 u.s. at 385-86 (breyer, j., dissenting joined by rehnquist, c.j., stevens, j., ginsburg, j.) (finding the alternatives suggested by the court not enough to recti­ fy the problem the government sought to address). 227. 44 liquormart, inc. v. rhode island, 517 u.s. 484,507 (1996) (emphasis added). 228. sorrell v. ims health inc., 131 s. ct. 2653, 2673 (2011) (breyer, j. dissenting, joined by kagan, j., and ginsburg, j.). "the majority cannot point to any adequately sup­ ported, similarly effective 'more limited restriction.' respondents' alternatives are no more helpful. vermont has thus developed a record that sufficiently shows that its statute mean­ ingfully furthers substantial state interests. neither the majority nor respondents suggests any equally effective 'more limited' restriction." id. at 2683 (citations omitted). 229. thompson, 535 u.s. at 385 (breyer j., dissenting joined by rehnquist. c.j., ste­ vens, j., ginsburg, j.) ("in fact, the fda's compliance policy guide, from which the court draws its first four alternatives, specifically warned that these alternatives alone were insuf­ ficient to successfully distinguish traditional compounding from unacceptable manufactur­ ing."). 152 indiana health law review [vol. 9:1 der to regulate harmful products. as the court has stated: "if the first amendment means anything, it means that regulating speech must be a last­ -not first-resort."230 these alternatives often take the form of regulating .. conduct." b. government restrictions on the use of characters on products 1. characters are deceptive and misleading under prong one of central hudson if the fda seeks to restrict the use of characters on product packag­ ing, a court would likely subject the restriction to scrutiny under the central hudson test. however, the government could initially argue that the use of characters to entice children is deceptive and misleading and thus, not pro­ tected by the first amendment.231 such a restriction on the use of charac­ ters would be aimed at addressing deceptive speech directed at children under prong one of central hudson. in this context the government would rely on the evidence that the use of characters is deceptive and misleading when used to target products to children. the research indicates that the use of characters is not just simply a persuasive advertising tool,232 but rather it actually deceives children to think they prefer the food adorned with them. 233 although tailoring is not technically necessary to meet prong one on 230. !d. at 373. 231. see lorillard tobacco co. v. reilly, 533 u.s. 525, 603 (2001) (stevens, j., con­ curring in part and dissenting in part) ("i note, moreover, that the alleged 'overinclusivity' of the advertising regulations, ... does not 'beli[e]' the claim that tobacco advertising imagery misleads children into believing that smoking is healthy, glamorous, or sophisticated[.] for purposes of summary judgment, the state conceded that the tobacco companies' advertising concerns lawful activity and is not misleading. under the court's disposition of the case today, the state remains free to proffer evidence that the advertising is in fact misleading."). see va. bd. of pharmacy v. va. citizens consumer council, inc., 425 u.s. 748, 771 (1976) ("[m]uch commercial speech is not provably false, or even wholly false, but only deceptive or misleading. we foresee no obstacle to a state's dealing effectively with this problem." (internal citation omitted); cf sorrell, 131 s. ct. at 2672 ('the state nowhere contends that detailing is false or misleading within the meaning of this court's first amendment prece­ dents."). 232. cf sorrell, 131 s. ct. 2653 at 2671 ("(t]he state may not seek to remove a popu­ lar but disfavored product from the marketplace by prohibiting truthful, nonmisleading ad­ vertisements that contain impressive endorsements or catchy jingles."). 233. see rich, supra note 116 ("growing up is a very strenuous, difficult, and some­ times hard and scary process for children. one of the things that gives them some stability and continuity in that is their attachment to touchstones in their lives. and among those touchstones are characters: clifford the big red dog. mickey mouse. these are constants in their lives. these are things that they have figured out, they feel they understand, and that they feel comfortable with, and indeed, in their own way, love. when you take that, and you leverage that into saying, 'eat this food,' you are basically leveraging that very powerful emotion that the child has-that very powerful attachment-to make money."). 2012) government intervention in unhealthy food promotions 153 its own, courts would likely look positively at the government's attempt to address the nutrition-related problems if that is its intent. since judges are swayed by their own notions and consider other elements of a law, the gov­ ernment would be wise to include guidelines on the ban on characters on food packaging. a well-researched and reasoned restriction is also prefera­ ble in case a court does not accept this argument under prong one and the restriction becomes subject to full central hudson scrutiny. therefore the restriction on the use of characters should be defined by the nutritional cri­ terion of the food and also account for adult-only products by excluding those items only purchasable by adults (e.g., beer) from the ban. the court has found that it is acceptable for the government to regu­ late specific "advertising in one industry but not in others, because the risk of fraud (one of the characteristics of commercial speech that justifies de­ priving it of full first amendment protection) is in its. view greater there. "234 here the risk of deception is the characteristic warranting less protection for characters on food products of poor nutritional value directed at children. if challenged in court, the government would argue that the use of characters on unhealthy food is inherently or proven in fact to be deceptive and misleading. the potentially misleading speech category does not ade­ quately capture or address this issue because the cure for potentially mis­ leading speech is more speech, in the form of a disclosure or disclaimer.235 this would not rectify the problem inherent with placing characters on un­ healthy food because children may not be able to comprehend the meaning of a disclaimer. this is true especially in the context of packaging where a disclosure or disclaimer would have to be written words (e.g., "hey kids, this character is trying to sell you something!"). many children for whom such protection is warranted cannot read and even those who can read, there is no evidence that such a statement could cure the deception or otherwise reduce the problems associated with such marketing. children are attracted to cha,racters on product packaging regardless of what food is in the package or words accompany the pictures and courts have recognized that the use of characters can be deceptive and misleading to children.236 one trademark infringement case supports this idea. a fed­ eral district found that the defendant infringed the complainant's trademark based on the similarity of the depiction of a female on the two companies' 234. ra. v. v. city of st. paul, 505 u.s. 377, 388-89 (1992) (internal citations omit­ ted) (citing morales v. trans world airlines, inc., 504 u.s. 374 (1992) (state regulation of airline advertising)); ohralik v. ohio state bar ass'n, 436 u.s. 447 (1978) (state regulation of lawyer advertising). 235. see an & stern, supra note 186, at 56 (one study of 112 girls and boys aged 8-11 tested the effects of "advertising breaks" in advergames and found the breaks did not help children detect the commercial nature of the game or identify the commercial entity's motive was to encourage them to consume the cereal promoted.). 236. john, supra note 1, at 198; brownell&horgen,supranote 115, at 106-107. 154 indiana health law review [vol. 9:1 labels, packages and boxes of chocolate.237 the court emphasized that the words upon the labels and wrappers did not appeal "as strongly to the mind of the consumer as did the picture.',a38 the court pointed out that, "it was through the picture" that the products became "popularly known to many persons, especially to children and others who are unable to read and write." 239 similarly, in an ftc case a company marketed vitamins with an image of spiderman, and the commission found this practice was unfair and de­ ceptive because the use of characters "has the tendency and capacity ... to take advantage of the trust relationship developed between children and the program character.''240 several cases are informative for the government if it attempts to re­ strict the use of characters on food products. in zauderer, the supreme court struck down a state's attempt to prohibit an attorney from using an accurate illustration of the dalkon shield (an intrauterine device subject to products liability lawsuits) in his advertising.z41 the court found the illus­ tration "serves important communicative functions: it attracts the attention of the audience to the advertiser's message, and it may also serve to impart information directly.'.242 it would be difficult to argue that characters on food products impart ''information" to children. 243 clearly they attract con­ sumers to the product, as does all successful marketing.244 however, this does not detract from their misleading nature on unhealthy food marketing directed at children. lower courts have both upheld and struck down government efforts to ban images in advertising for service and products intended for adults. cases where courts analyze attorney advertising to adult consumers, who are considered in need of enhanced protection in that context,245 provide a 237. walter baker & co. v. puritan pure food co., 139 f. 680 (c.c.s.d.n.y. 1905) •. 238. !d. at 683. 239. !d. 240. in re hudson pharmaceutical corp., 89 f.t.c. 82, "'4-5 (1977) (consent order to stop advertising using characters) (the ftc expressed the concern that the use of characters could "induce children to take excessive amounts of vitamin supplements which may cause injury to their health."); see also ackerman v. coca-cola company, 2010 u.s. dist. lexis 73156, at "'16, 25-26 (july21, 20l0); rich,stq)ranote 116. 241. zauderer v. office of disciplinary counsel of the sup. ct. of ohio, 471 u.s. 626, 644, 649 (1985). 242. !d. at647. 243. cf sorrell, 131 s. ct. 2653 at 2671-72 (2011) (discussing how the state cannot burden "information"). 244. cf id at 2671 ("[t]he state may not seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles.j. 245. see, e.g., in re felmeister & isaacs, 104 n.j. 515, 536 (n.j. 1986) (the new jer­ sey supreme court said: "we do not believe that the constitution requires that the rules governing attorney advertising be the same as those applicable to beer, automobiles, or casi­ no hotels."); cf zauderer v. office of disciplinary counsel of the sup. ct. of ohio, 471 u.s. 626, 677 (1985) (o'conner, j., concurring and dissenting) (''the court's commercial speech decisions have repeatedly acknowledged that the differences between professional services 2012] government intervention in unhealthy food promotions 155 compelling example because children are similarly disadvantaged in the context of marketing directed at them. state supreme courts have upheld restrictions on attorney advertising using pictorial depictions such as a car­ toon logo, animation, or drawings. in one attorney advertising case, the supreme court of florida found two attorneys' advertisements violated rules prohibiting "statements de­ scribing or characterizing the quality of the lawyer's services in advertise­ ments" and requiring that "[v]isual or verbal descriptions, depictions, or portrayals of persons, things, or events must be objectively relevant to the selection of an attorney and shall not be deceptive, misleading, or manipula­ tive."246 the court found that the attorneys' use of a logo of the pit bull wearing a spiked collar and the prominent display of the phone number 1800-pit -bull were manipulative and misleading because they did not convey objectively relevant information about the attorneys' practice, but rather conveyed an image about the nature of the lawyers' litigation tactics connoting combativeness and viciousness without providing accurate and objectively verifiable factual information?47 the court found that these representations were inherently deceptive and fell outside the protections of the first amendment.248 courts clearly find adult consumers of attorney services in need of in­ creased protection from misleading and deceptive speech. even if courts would not go as far to protect adults in other contexts, children should be considered worthy of similar protection from overreaching by commercial i and other advertised products may justify distinctive state regulation."). 246. fla. bar v. pape, 918 so.2d 240,242 (fla. 2006). 247. id. 248. jd.; see also in re felmeister & isaacs, 104 n.j. 515 (n.j. 1986) (the supreme court of new jersey revised the attorney advertising rules governing professional conduct and subjected them to first amendment scrutiny under the central hudson test. the rules allow lawyers to advertise services through public media but require all advertisements to be "predominantly informational" and ban "drawings, animations, dramatizations, music, or lyrics" in televised advertising. id. at 553. the court found that the ban met the central hudson test because such images on television would create "undue irrational influence on consumers in their selection of counsel." id. it further explained that, "the danger, in televi­ sion advertising, of such non-rational techniques is so great that even restricting them to the point where the entire ad is 'predominantly informational' is not sufficient protection." id. interestingly the court distinguished the drawings in print advertising because it did not think it had the same influence. the court quoted the iowa supreme court's rationale in the con­ text of a rule banning all television advertising by attorneys: "[e]lectronic media advertising, when contrasted with printed advertising, tolerates much less deliberation by those at whom it is aimed . . . . lost is the opportunity accorded to the reader of printed advertisements to pause, to restudy, and to thoughtfully consider." (quoting comm. on prof! ethics & con­ duct v. humphrey, 377 n.w.2d 643, 646 (iowa 1985)). the dissent believed the regulatory requirement that televised attorney advertisement of legal services must be "predominantly informational" was potentially unconstitutional, against public policy and potentially un­ manageable. the dissent opined that advertising should only be restricted if it is misleading, confusing or false and agreed with the majority that a prohibition against the use of drawing, animations, dramatization, music and lyrics in print and other non-televised media would violate the first amendment. id. at 553-565; see also felmeister v. office of attorney eth­ ics, div. n.j. admin. office of courts, 856 f.2d 529,532 {3d cir. 1988)). 156 indiana health law review [vol. 9:1 entities seeking to sell them unhealthy products. there is also a good argument that promotional tactics directed at young children, who cannot understand their persuasive intent, are inherent­ ly misleading according to the original conception of this category of un­ protected speech. 249 both licensed characters and spokescharacters are not inherently associated with the product or its attributes. for example, spongebob squrepants is on dozens of products ranging from fast food to cereal to cookies.250 and tony the tiger was not associated with cereal or frosted flakes until he acquired such a meaning over time through his ap­ pearance in advertisements and on product packaging. the resulting posi­ tive association between tony and frosted flakes does not necessarily reflect any claim or characteristic of the product promoted, and thus the product itself can be manipulated (e.g., to be less healthy) but the positive association between the character and the brand will remain. this was the basis for the holding in friedman v. rogers, where the court found that: a trade name conveys no information about the price and nature of the services offered by an optometrist until it acquires meaning over a period of time by as­ sociations formed in the minds of the public between the name and some standard of price or quality. be­ cause these ill-defined associations of trade names with price and quality information can be manipulated by the users of trade names, there is a significant pos­ sibility that trade naines will be used to mislead the public.251 similarly, characters convey ''no information;" and their association with a product "acquires meaning over a period of time" and "can be ma­ nipulated" to "mislead" child.ren.252 249. see angela j. campbell, restricting the marketing of junk food to children by product placement and character selling, 39 loy. l.a. l. rev. 447 (2006) (arguing that product placement and licensed character marketing to children is misleading and deceptive and not protected by the first amendment). 250. campaign for commercial-free cmwhood, supra note 119; see also press release, campaign for commercial free childhood. shrek food, http://www.commercialexploitation.org/pressreleases/shrekfood.htm; press release, cam­ paign for commercial free childhood, ccfc to health and human services: fire shrek, (apr. 26, 2007), http://www.commercialexploitation.org/pressreleaseslfireshrek.htm (shrek has b~ associated with at least fifteen different categories of food for dozens of individual products, including cereal, candy, fast food and cookies.). 251. friedman v. rogers, 440 u.s. 1, 12-13 (1979); see also fla. bar v. pape, 918 so.2d 240, 244-49 (fla. 2006) (this was also similar to the supreme court of florida's con­ cern with the pit bull imaging in the attorney advertisements, that it conveyed manipulative and misleading connotations about the services advertised.). 252. friedman, 440 u.s. at 12-13. 2012] government intervention in unhealthy food promotions 157 characters are not "information" in and of themselves (unlike the dalk:on shield in zauderer).253 children are attracted to perceptually salient features of product packaging that are not relevant to the actual product marketed.254 thus, only after time are children able to match product spokescharacters to the product without seeing an advertisement for the ac­ tual product. further, it is likely that young children cannot distinguish be­ tween characters they saw in cartoon programs from those in cartoon commercials when faced with the same characters on product packaging in the retail environment.255 2. refuting industry responses industry would attempt to support the position that the use of charac­ ters should be protected as commercial speech and thus any restriction on their use must pass full central hudson scrutiny. industry could make sev­ eral arguments to advance this position: that the characters are intended for a general audience, are used to propose a commercial transaction to a child, are used to communicate with adults that the products are intended for chil­ dren, or are used to appeal to adults' nostalgia of their childhood. each ar­ gument will be addressed in turn. first, not all characters can reasonably be said to appeal to a general audience. a licensed character such as dora the explorer, who is on nick jr. which is explicitly directed at young pre-school aged children,256 is like­ ly intended to attract very young children to products bearing her likeness. in contrast, a character from the movie avatar may not similarly qualify for restriction because that movie was pg-13 and thus intended for teens and adults. in order to prevent such an industry challenge, the government would want to tailor its restriction to reach the characters directed at youth. the government could use the ftc's definitions to this end. second, the government could argue that even if industry is attempting to propose a commercial transaction with children, it is a deceptive method since children inherently do not understand that the characters are used to 253. see sorrell, 131 s. ct. at 2671 ("'the defect in vermont's law is made clear by the fact that many listeners find detailing instructive. indeed the record demonstrates that some vermont doctors view targeted detailing based on prescriber-identifying information as 'very helpful' because it allows detailers to shape their messages to each doctor's practice."). 254. john, supra note 1. 255. media bureau action: comment dates established for campaign for a commer­ cial-free childhood petition for a declaratory ruling that a program to be aired by nick­ toons violates the children's television act and the fcc's rules and policies, 25 fcc red 13226 (2010) (concerns over this reverse situation bave been expressed to the fcc in a petition to consider whether the makers of sketchers shoes can have a cartoon with the com­ pany's spokescbaracter, zevo-3 as the main character); see also petitioj1 for declaratory ruling filed by campaign for commercial-free childhood (sept. 13, 201 0), http://www.commercialexploitation.orglpdf7skecbersfccpetition.pdf. 256. see generally dora 1hb explorer, http://www.nickjr.com/dora-the-explorer/. 158 indiana health law review [vol. 9:1 manipulate their food-related requests, enjoyment, and behaviors.257 in the studies discussed above in section iii, the presence of a familiar character became unduly influential and manipulated the children's beliefs and be­ haviors with respect to the promoted food product. in addition, every time a child sees the character in a movie or television show, it is essentially an advertisement for the food product bearing the same character.258 this takes unfair advantage of the trust which children place on the character.259 the food product becomes an extension of the cartoon experience and thus the concern exists when a beloved character is smiling at children from the packaging of unhealthy food. recall barbie cereal, a product that "'ex­ tends the fantasy:"' the "doll on the-box and the shapes of the cereal carry on the dream world of barbie. little girls who 'play barbie' can pretend they're sitting down to have breakfast with her."260 the entire purpose of placing a character on the package is to extend the cartoon experience into the commercial realm.261 characters on product packaging are not akin to the daikon shield illustration in zaudere?62 or words (like price or alcohol content) in virginia pharmaci63 and rubin v. coors brewing co.264 some children do not even know they are not real when seen on television. third, industry could use words on the package to communicate with adults that the products are intended for children. industry could also ad­ vertise this fact via other media targeted to adults. characters themselves are not informational to adults or children. fourth, the argument that spokescharacters appeal to adults' nostalgia 257. roberto et al., supra note 124. 258. campbell, supra note 253 (quoting susan linn, consuming kids: the hostile takeover of child-hood 97 (2004)). 259. see in the matter of policies and rules concerning children's television pro­ gramming, 6 fcc red. 5093 (1991) (''host-selling prohibits the use of program talent or other identifiable program characteristics to deliver commercials. it is a special application of our more general policy requiring separation of program and commercial material in order to help children distinguish between the two. host-selling also takes unfair advantage of the trust which children place in program characters. this policy would prohibit, for example, use of a cartoon character depicted in a children's program to sell a product in a commercial aired in close proximity to the program. it would not, however, as trac suggests, prevent an unrelated program host from selling products that are not associated with a preceding or subsequent children's program."). 260. miller, supra note 6. 261. see, e.g., richard mizerski, the relationship between cartoon trade character recognition and attitude toward product category in young children, 59 j. marketing 58 ( 1995) (company spokescharacters have been shown to increase recognition and liking of the associated product by children); see a/so adriana barbaro & jeremy earp, consuming kids: the commercialization of childhood (media education foundation 2008). 262. zauderer v. office of disciplinary counsel of the sup. ct. of ohio, 471 u.s. 626, 648 (1985) (the government failed to present evidence of harm, ''potential abuses," and that the illustrations at issue were "likely to deceive, mislead, or confuse" adult consumers). 263. va. state bd. of pharmacy v. va. citizens consumer council, inc., 425 u.s. 748 (1976). 264. rubin v. coors brewing co., 514 u.s. 476,481 (1995); see also bad frog brew­ ery, inc. v. n.y. state liquor auth., 134 f.3d 87,96-97 (2d cir. 1998). 20 12] government intervention in unhealthy food promotions 159 for their youth is a circular argument because it starts out targeting children in order to appeal to nostalgia for childhood. restricting the use of these spokescharacters on packaging would not interfere with companies' ability to market the product to adults via other media directed at the adult popula­ tion. finally, note that the cfbai does to apply to any company spokes­ characters on packaging, and only two companies marginally restrict the use of licensed characters on their packaging. the companies are likely aware that these characters are influential and effective in attracting chil­ dren to their products, mostly of very poor nutritional value.265 since nothing like this has been litigated under prong one of central hudson, it is unclear how a court would rule on such an argument. the government has a good argument that such practices are inherently mislead­ ing or proven to be misleading through the evidence presented and not pro­ tected by the first amendment. otherwise, a court would subject the restriction to the full central hudson test. 3. character restrictions should pass the central hudson test assuming a court did not find that the use of characters to be decep­ tive and misleading on child targeted products, it would analyze any re­ strictions under the remaining prongs of the central hudson test. the case law provides limited insight into how a court would rule on such a re­ striction; however, the government has a strong argument that a regulation restricting the use of characters based on the nutritional quality of the food should survive review under central hudson scrutiny under the rationale regarding regulation of the attorney advertising and similar cases. 266 most licensed characters and spokescharacters are placed on food products of poor nutritional quality. the goal would be to limit the use of spokescharacters and licensed characters to be present only on actually healthy foods, such as fresh or frozen vegetables, to prevent the exploitation of children and overreaching by commercial actors. assuming a court found the characters are protected commercial speech under prong one, the court would analyze the restriction under the remaining prongs of the central hudson test. in the context of government restrictions on food promotion to children, the government should frame its interests in terms of protecting public health, protecting children from commercial exploitation and overreaching by commercial actors, and ad265. see, e.g., jennifer l. harris et al., yale rudd center for food poltcy & obesity, cereal f.a.c.t.s.: evaluating the nutrition quality and marketing of children's cereals, report summary. available at http:/ /www.cerealfacts.org/media/cereal _facts_ report_ summary.pdf 266. this could be limited to product packaging (and enforced by the fda) or expand­ ed to include commercials (and simultaneously enforced by the ftc). 160 indiana health law review [vol. 9:1 dressing manipulated nutrition-related beliefs and behaviors of children. because prong three of central hudson requires the state to show "not merely that its regulation will advance its interest, but also that it will do so 'to a material degree,".267 a court may not sustain a oommercial speech reg­ ulation '"if it provides only ineffective or remote support for the govern­ ment's purpose.".268 these goals are actually attainable and supported by the evidence. under prong two, the government has a substantial interest in protect­ ing ·public health, protecting children from commercial exploitation and overreaching by commercial actors, and addressing the manipulation of children's nutrition-related beliefs and behaviors. courts recognize the government has a substantial interest in promoting and protecting the public health, safety and welfare.269 the fda has at its core mission to protect public health.270 the government also has an interest in protecting children from over­ reaching by companies seekin~ to make a profit off of them through manip­ ulative commercial practices. 71 in board of trustees v. fox, the court accepted as one of four government interests the . interest in "preventing commercial exploitation of [college] students.'.272 preventing the commer­ cial exploitation of young children is likely more important than for college students. this is part and parcel to the government's interest in rectifying the manipulated nutrition-related beliefs and behaviors of children. this argument is not about addi:essing simple persuasive advertising,273 but ra267. 44 liquormart, inc. v. rhode island, 517 u.s. 484, 505 (1996) (quoting edenfield v. fane, 507 u.s. 761,771 (1980)). 268. id (quoting central hudson gas & elec. corp. v. public serv. comm'n of n.y., 447 u.s. 557, 564 (1980)). . 269. see, e,g., rubin v. coors brewing co., 514 u.s. 476, 485 (1995) (finding the government has a significant interest in protecting the health, safety, and wel~e of its citi­ zens). see also fla. bar v. went for it, inc., 515 u.s. 618, 625 (1995) ("'states have a com­ pelling interest in the practice of professions within their boundaries, and ... as part of their power to protect the public health, safety, and other valid interests they have broad power to establish standards for licensing practitioners and regulating the practice of professions."') (quoting goldfarb v. va. state bar, 421 u.s. 773, 792 (1975)). see also sorrell v. ims health inc., 131 s. ct. 2653, 2681 (2011) (breyer, j., dissenting) (''the protection of public health falls within the traditional scope of a state's police powers.''). 270. fda fundamentals, u.s. food & drug administration (2011), http:/ /www.fda.gov/ aboutfda!fransparency!basicslucml9269s.b.tm ("fda is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines.and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off radiation.''). 271. bd. oftr. of the state univ. ofn.y. v. fox, 492 u.s. 469 (1989). 272. /d. at 475. 273. cj sorrell. 131 s. ct at 2671 ("[1]he state defends the law by insisting that 'pharmaceutical marketing has a· strong influence on doctors• prescribing practices.' brief for petitioners 49-50. this reasoning is incompatible with the first amendment in an at­ tempt to reverse a disfavored trend in public opinion, a state could not ban campaigning with slogans, picketing with signs, or marching during the daytime. likewise the state may not seek to remove a popular but disfavored product from the marketplace by prohibiting truth2012] government intervention in unhealthy food promotions 161 ther rectifying the use of characters to manipulate children to believe the products taste exceptional or to induce children to nag their parents for the­ se unhealthy food products. 274 characters are not a form of commercial information the first amendment has traditionally been interpreted to pro­ tect.275 under prong three,-the government would need to show the restriction directly advances the interests proffered under prong two.276 the govern­ ment would present the evidence reviewed above showing that characters influence children's beliefs and behaviors with respect to the food subject to such promotions. 277 the evidence reveals that children prefer the taste and choose the identical product with licensed characters. further, such charac­ ters are currently on mostly unhealthy food products. this might be con­ sidered "hard sell" tactics inappropriate for children.278 in an attorney advertising case decided prior to central hudson, the court upheld a state ban on in-person direct solicitation of an attorney to accident victims, based on the potential for overreaching, invasion of priva­ cy, and undue influence.279 ln a 2007 case, tennessee secondary school athletic ass'n. v. brentwood academy, a coach violated the school's agreement as part of an athletic association not to recruit "impressionable middle school athletes" by sending a letter about getting involved in foot­ ball early and the plurality found the association's sanctioning of the school did not violate the first am.endment.280 although the plurality opinion did not rely on ohralik, four justices referenced · ohralik to analyze first amendment issues pertinent to a contractual agreement.281 the plurality ful, nomnisleading advertisements that contain impressive endorsements or catchy jingles. that the state finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.''). 274. in the core speech realm, the court recognized (but did not value) the govern­ ment's interest in "helping concerned parents control their children." brown v. entm't merchs. ass'n, 131 s. ct. 2729, 2741 (2011). in the commercial context, the government would be seeking to address in order to assist parents in their role as "nutritional gatekeep­ ers" for the family. bellotti v. baird, 443 u.s. 622,634 (1979) (recognizing ''the importance of the parental role in child rearing"). it is unclear whether this argument is still viable since brown. 275. see sorrell, 131 s. ct. at 2671 ("th.e defect in vermont's law is made.clearby the fact that many listeners find detailing instructive. indeed the record demonstrates that some vermont doctors view targeted detailing based on prescriber-identifying information as 'very helpful' because it allows detailers to shape their messages to each doctor's practice."). 276. cent. hudson gas & electric corp. v. pub. serv. comm'n ofn.y., 447 u.s. 557, 564(1980). 277. roberto et al., supra note 124, at 88-93. 278. see, e.g., tenn. secondary sch. athletic ass'n v. brentwood acad., 551 u.s. 291, 300 (2007). 279. ohralik v. ohio state bar ass'n., 436 u.s. 447 (1978). but see edenfield v. fane, 507 u.s. 761 (1993) (declining to extend ohralik outside the attorney advertising context to accountants). 280. tenn. secondary sch. athletic ass'n v. brentwood acad., 551 u.s. 291, 296 (2007). 281. jd. at 299 (stevens, j.,joined by souter, ginsburg, breyer, jj.); 162 indiana health law review still found that: we need no empirical data to credit tssaa's com­ mon sense conclusion that hard-sell tactics directed at middle school students could lead to exploitation, dis­ tort competition between high school teams, and fos­ ter an environment in which athletics are prized more highly than academics.282 [vol. 9:1 the "hard-sell tactics" that created a concern for exploitation were only the letters addressed to the middle school students. in lorillard tobacco co. v. reilly, the court agreed that product ad­ vertising stimulates demand for products and that suppressing advertising may have the opposite effect?83 in that case, the government successfully presented evidence to pass prong three by submitting reports by govern­ ment agencies and the 10m that established that limiting youth exposure to advertising would decrease underage use of tobacco products. 284 the same type of evidence is available in the food context: the 10m report and pub­ lished studies from reputable institutions and universities. the government should similarly be able to pass prong three here. under prong four, the government can show that the a nutritionally­ based restriction on child-targeted characters that exclude adult-only prod­ ucts is not more extensive than necessary to serve the government's interest in public health and protecting children from manipulation and commercial exploitation.285 first, the use of nutrition and adult-only standards indicates proper tailoring, as does using the ftc definition of targeting youth to de­ termine which foods should be subject to restriction. the regulation like­ wise directly addresses the harm the government seeks to rectify, without restricting speech to adults.286 by tailoring the restriction to child-oriented food, this regulation would not reduce commercial speech intended for or used by adults to make purchase decisions. restricting characters would not be restricting any particular commercial message or commercial speech intended for adults. manufacturers can use words on packaging to indicate that food it intended for children or communicate other infoqnation to adult consumers. when the court has strikes down a commercial speech restriction un282. /d at 300 (emphasis added). 283. lorillard tobacco co. v. reilly, 530 u.s. 525, 557 (2001). 284. id. at 561. 285. cent. hudson gas & electric corp., 447 u.s. at 564. 286. see, e.g., bad frog brewery v. n.y. state liquor auth., 134 f.3d 87, 92 (2d cir. 1998) (the court reminded the parties that other characters have been used to market beer, including the budweiser frogs, spuds mackenzie and the bud-ice penguins and rejected the advertising restrictions.). 20 12] government intervention in unhealthy food promotions 163 der prong four, it often points to regulations of conduct that it deemed via­ ble alternatives to regulating speech that the government should have con­ sidered. in this context, the court has pointed to specific regulations of conduct available to government seeking to protect the public from harmful products, including directly banning the product/87 limiting per capita pur­ chases,288 prohibiting the purchase by minors/89 and implementing specific restrictions on sale such as requiring harmful products to be placed in spe­ cific areas.290 absent a politically and logistically impossible federal law banning the sale of all unhealthy food and beverages, alternative forms of regulation would not achieve the governments' interests under prong four. for exam­ ple, taxation291 of food products packaged with characters would not achieve the governments' interests because manufacturers would likely pass on the cost to consumers and thus the products that induce children to have unhealthy nutrition related beliefs and behaviors would simply be more ex­ pensive, increasing the difficulty parents already face while being nagged for those products. education campaigns directed at adults may help parents to under­ stand that the products are unhealthy, but this again would not diminish the impact on children who do not understand such messages. similarly, media literacy campaigns have not shown to be effective to couiiteract food adver­ tising effects for children.292 consider that children ages two to three years can recognize familiar packages in the stores and familiar spokescharacters on food products; by the time they enter the first grade children are familiar with roughly 200 brands,293 and their food preferences are well established at this point.294 practically, the government would not have jurisdiction to intervene until children enter public elementary school, which is well after their food preferences are established. only older children have the capaci­ ty to understand media literacy education because children under eight years of age cannot comprehend persuasive intent,295 and even for those who can, this has not been proven effective at moderating the influence of 287. 44 liquormart, inc. v. rhode island, 517 u.s. 484, 524 (1996) (thomas, j., con­ curring in part and concurring in judgment). 288. i d. at 507. 289. lorillard tobacco co., 533 u.s. at 586 (thomas, j., concurring in part and concurring in the judgment). 290. id. at 569-70. 291. 44 liquonnart, inc., 517 u.s. at 507. 292. jennifer l. harris & john a. bargh, the relationship between television viewing and unhealthy eating: implications for children and media interventions, in health commun. 660, 660....73 (2009). 293. commfitee on food mar.ketrng and the diets of children and youth, threat or opportunity? 1 03 (j. michael mcginnis, et al. eds., 2006). 294. harris & bargh, supra note 295. 295. commmee on food mar.ketrng and the diets of children and youth, supra note 299, at 327. 164 indiana health law review [vol. 9:1 ad exposure on product preference~ 296 thus, training in the use of powers of discernment requires that youth have reached a certain developmental stage, which only occurs after their food related beliefs and behaviors are estab­ lished.297 ·importantly, increased nutrition knowledge by children has not led to changes in dietary behavior except to result in lower perceived taste for those foods.298 in fact in one study of children ages five to eleven, exposure to a video that explained the purpose of advertising resulted in an increase in the children's preferences for the advertised products?99 even if media literacy actually worked, the government could not afford to match the $1.6 billion spent by industry to market food to children.300 according to the analysis above, the fda has a strong argument that a restriction on the use of characters on unhealthy food and beverage products should withstand scrutiny under the central hudson test. in this context, the court has upheld a federal agency's ability to restrict indecent language on broadcast media and called sports recruitment letters to middle school "hard sell" tactic. cartoon characters on product packaging may seem be­ nevolent, but the resulting poor nutrition related beliefs and behaviors is arguably much more harmful to children than these cases indicate, and par­ ents cannot shield children from them when shopping in the supermarket. this restriction is a potentially viable option to address the negative impact the current retail food environment has on children. c. other package restrictions as indicated in the review of research above, manufacturers use other techniques to market unhealthy food products to children, but there is not the same amount of research on efficacy of these methods as the use of characters. there is no case on point but a recent case in the tobacco con­ text will likely inform future action in this area. the federal government restricted the use of color on tobacco labeling and advertising, including depictions of the package in the advertisement but not the packages them­ selves, based on the theory that color is used to attract children. 301 the to­ bacco· industry challenged the regulations and the district court found that 296. ariel chernin, the relationship between children's knowledge of persuasive in­ tent and persuasion: the case of televised food marketing, (jan. i, 2007) (dissertation, univ. ofpa. ), available at http://repository.upenn.edu/dissertations/ aai32920 15/. 297. commtitee on food marketing and the diets of children and youth, supra note 298, at 327. 298. harris & bargh, supra note 298. 299. chernin, supra note 299. 300. brownell & horoen, supra note 115, at 106. 301. family smoking prevention and tobacco control act of2009, pub. l. no. 11131, 123 stat. 1776 (2009). . 20 12] government intervention in unhealthy food promotions 165 the ban on the use of color was overbroad and unconstitutional. 302 the sixth circuit affirmed this finding, explaining that the government cannot institute a "sweeping ban" on color, but rather must identify and target "on­ ly the speech necessary to effect its purposes. "303 it is noteworthy that the sixth circuit identified as valid the tobacco companies' interests in "simply showing the package" in their advertising in order to "reinforce consumer preference," let customers "know their preferred brand" 304 is sold at a par­ ticular retailer, and grab consumer attention "in a crowded marketplace." 305 lastly, addressing the practice of using premiums for unhealthy food is one additional practice that might be accessible to the fda. this would not be an alternative to regulating the use of characters, but rather a poten­ tial regulation of conduct. the fda could restrict the ability of manufac­ turers to include premiums with foods not meeting strong nutritional guidelines. this would only address one part of the problem with unhealthy food targeted to children (and in essence only for one type of product be­ cause over 90% of the premiums were used for cereal promotion). this regulation could perhaps be part and parcel of a restriction on the use of characters on products. federal courts that have analyzed restrictions on the use of premiums in tobacco products have found that they survive central hudson review or have found them to be valid regulations of conduct.306 in 302. commonwealth tobacco v. united states, 678 f. supp. 2d 512 (w.d. ky. 2010). 303. discount tobacco city & lottery v. united states, nos. 10-5234 & 5235, 2012 lexis 5614, at *89 (6th cir. mar. 19, 2012). 304. the supreme court held that a trade name constitutes commercial speech in friedman v. rogers; and lower courts have found other trade, brand and corporate names to be commercial speech.in subsequent cases. friedman v. rogers, 440 u.s. 1, 11 (1979); piazza's seafood world, llc v. odom, no. 3:02cv458(mrk), 2004 u.s. dist. lexis 25991, at *7 (e.d. la. dec. 23, 2004) ("the parties agree that a trade name constitutes commercial speech, and that regulations on commercial speech are subject to the four-part test articulated by the supreme court in central hudson gas v. public service commission, 447 u.s. 557, 65 l. ed. 2d 341, 100 s. ct. 2343 (1980)); kalman v. cortes, 723 f. supp. 2d 766, at 792-95 (e.d. pa. 2010). trademarks are considered to ''play a significant role in our public discourse" as is other types of commercial speech. alex kozinski (ninth circuit judge), trademarks unplugged, 68 nyu l. rev. 960, 972-973 {1993). accordingly, re­ strictions on their use have been analyzed under the central hudson test. piazza 's seqfood world, llc v. odom, no. 04-690, 2004 u.s. dist. lexis 25991, at *7 (e.d. la. dec. 23, 2004); see also bad frog brewery v. n.y. state liquor auth., 134 f.3d 87, 96-97 (1998) ("bad frog's label attempts to function, like a trademark, to identify the source of the prod­ uct."). the supreme court also held that color alone can meet the standard for trademark protection. qualitex co. v. jacobson products co., 514 u.s. 159, 166 (1995) (green-gold dry cleaning press pads); see also capri sun inc. v. beverage pouch systems inc., no. 97 c 1961, 2000 u.s. dist. lexis 10966, at *2, *14 n.3 (n.d. ill. july 24, 2000) (blue pouch packaging); hershey foods corp. v. mars, inc., 998 f. supp. 500, 507 (m.d. pa. 1998) (or­ ange trade dress). 305. discount tobacco city & lottery v. united states, nos. 10-5234 & 5235, 2012 lexis 5614, at *88 (6th cir. mar. 19, 2012). 306. commonwealth tobacco, 678 f. supp. 2d at 538-539 (finding companies do not "have any first amendment interest in rewarding purchasers of tobacco products with 'priz­ es, such as mp3 players, digital cameras, and prepaid gift cards"'); but see discount tobac­ co city & lottery, inc. v. united states, nos. 10-5234 & 5235,2012 lexis 5614, at *73-74 166 indiana health law review [vol. 9:1 the area of food, there is research indicating that premium offers induce purchase requests by children. there is a good argument that a restriction on the use of premiums should be analyzed as a regulation of conduct, dis­ cussed further below. 307 vi. regulation of in-store promotions and placement local retail establishments are subject to the jurisdiction of state and local (hereinafter state) governments. state governments may seek to regu­ late the techniques directed at children in the food retail environment, in­ cluding on and off shelf displays, ads, and promotions.308 if the government were to address in-store techniques, there are two ways it could address them. the government could attempt to restrict in-store advertisements or it could regulate the location of products, in-store displays, and promotions. there is little case law on restricting in-store advertisements and the latter regulations of conduct provide an alternative to regulating speech. 309 a. in-store advertising restrictions in terms of framing an in-store advertising restriction, the government would need to consider appropriate and inappropriate locations. the ftc's definition of in-store advertising and promotions accounted for the height of the advertising display or promotion to verify whether it was intended to reach youth.310 the primary case relevant to restrictions on in-store adver­ tising directed at children was based on industry challenges to a restriction determined by the height of the advertisement. in lorillard tobacco co. v. reilly, massachusetts sought to prohibit the advertisement of tobacco prod­ ucts from being placed lower than five feet from the floor of any retail es­ tablishment located within 1000 feet of a school or playground.311 the court considered this restriction an attempt to "regulate directly the com­ municative impact of indoor advertising" and found that it failed prongs (6th cir. march 19, 2012) (finding this provision is subject to and survives central hudson scrutiny). but see, jones v. vilsack, 272 f.3d 1030, 1035-1036 (8th cir. 2001) (describing a state law banning the provision of "free articles, products, commodities, gifts, or concessions in any exchange for the purchase of cigarettes or tobacco products" as a restriction on "activities" or "conduct" but fmding the provision preempted by the federal cigarette labeling and advertising act which bars states from regulating the "advertising or promotion of any ciga­ rettes"). 307. atkin, supra note 93, at 41. 308. gma sales comm. & booz & co., shopper marketing 4.0: building scalable playbooks that drive results 5 (nov. 9, 2010), http:/ /www.gmaonline.org/downloadslresearch-and-reports/shopper _marketing_ 4.0.pdf. 309. thompson v. w. states med. ctr., 535 u.s. 357, 373 (2002). 310. marketing food to children and adolescents: appendices, supra note 14, at b-7, b-18, b-32, c-7. 311. lorillard tobacco co. v. reilly, 533 u.s. 525, 566 (2001) (quoting 940 mass. code regs. §§ 21.04(5)(b), 22.06(5)(b) (2000)). 2012] government intervention in unhealthy food promotions 167 three and four of the central hudson test.312 the court did not explicitly analyze the restriction according to each prong of the test but found that the five foot rule did ''not seem to advance" the goal of preventing minors from using tobacco products because "[ n ]ot all children are less than 5 feet tall, and those who are ... [certainly have the ability to] look up and take in their surroundings."313 the court's rationale is broadly stated and focuses on lack of efficacy of the speech restriction. since lorillard addressed in-store advertisements for products chil­ dren are not legally allowed to purchase, the court's rationale, while broad­ ly stated, may not directly apply to targeted marketing of unhealthy products to children. if the government had attempted to ban the adver­ tisement of products purchasable by adults and children, such as candy be­ low five feet, industry would argue that the rationale would equally apply.314 but there are substantial differences. although as a product, to­ bacco is generally considered a greater threat to public health than un­ healthy food, tobacco ads are presumably directed at adults. in-store food 312. ld. at 566-67 (interestingly, in lorillard, the supreme court compared the tobac­ co ads to displays of candy: "massachusetts may wish to target tobacco advertisements and displays that entice children, much like floor-level candy displays in a convenience store, but the blanket height restriction does not constitute a reasonable fit with that goal." the prob­ lem with the court's analogy is that floor level candy displays are not advertising in and of themselves. rather, they are a sales mechanism. regulations of sales practices within retail establishments are not analyzed under central hudson, as indicated later in the lorillard opinion and discussed below. but perhaps the thrust of the statement was to note is that the court was referring to the enticement of the candy display and compared it to the enticement of tobacco advertising. the real issue is that even if we know that the a colorful sign three feet from the floor advertising candy appeals to children more than adults, candy is an item that adults purchase and consume and for which adults have a first amendment right to receive marketing messages. the issue changes, however, when analyzing a restriction on the location of the candy display itself or a restriction on the use of specific marketing tech­ niques on the display such as the use of a licensed character geared towards young consum­ ers.). 313. lorillard tobacco co., 533 u.s. at 566. 314. see id. at 588-89 (thomas, j., concurring in part and concurring in the judgment). (justice thomas compared tobacco with fast food and explained that fast food companies overtly target children with their advertising, there is evidence that they have been successful in changing children's eating behavior, and this is a problem due to both childhood obesity and the fact that eating preferences formed in childhood persist into adulthood. however, he would find that restrictions on fast food advertising to children should similarly fail first amendment scrutiny. he found that tobacco companies "are no different from the purveyors of other harmful products, or the advocates of harmful ideas. when the state seeks to si­ lence them, they are all entitled to the protection of the first amendment."); but see brown v. entm't merchs. ass'n, 131 s. ct. 2729, 2752 (2011) (thomas, j., dissenting) ("the histor­ ical evidence shows that the founding generation believed parents had absolute authority over their minor children and expected parents to use that authority to direct the proper de­ velopment of their children. it would be absurd to suggest that such a society understood 'the freedom of speech' to include a right to speak to minors (or a corresponding right of minors to access speech) without going through the minors' parents. the founding genera­ tion would not have considered it an abridgment of 'the freedom of speech' to support paren­ tal authority by restricting speech that bypasses minors' parents."). 168 indiana health law review [vol. 9:1 advertising often consists of characters targeted only to young children, set­ ting it apart from the tobacco ads. if the government attempted to ban such an advertisement, food retailers and manufacturers would likely argue that it interferes with their ability to communicate with adults (and children) and should fail under the rationale stated in lorillard. the government can make the same arguments as under section iii, above in relation to product packaging about in-store advertisements di­ rected at children. state governments have an interest in protecting children from overreaching by commercial marketers who use "hard sell" tactics to induce the request and purchase of unhealthy products by children. the difference between this argument in relation to in-store advertising and packaging is that package promotions have been studied and proven suc­ cessful, while there is less research on in-store advertising. increased re­ search on in-store advertising tactics would likely benefit state governments that wish to regulate this aspect of the retail environment. in addition, there is little case law on the topic of regulating in-store advertising beyond this section of the lorillard opinion. while this area of research develops, state governments may alterna­ tively seek to regulate the location of products within the retail environ­ ment. the goal of such regulations would be to target conduct instead of speech. regulations of conduct are not subject to central hudson analysis. pure regulations of conduct are not subject to first amendment scrutiny at all, and regulations of conduct with an expressive component are subject to a different intermediate test developed in the case of united states v. o'brien. although both are considered intermediate tests, o'brien has proven easier to pass than central hudson because the first amendment implications are diminished when the government regulates conduct instead of speech.315 b. in-store regulations of conduct in order to address the most problematic aspects of the retail environ­ ment directed at children, there are two regulations of conduct state gov­ ernments could implement. first, the government could regulate the location of products not meeting nutritional guidelines, and second, it could regulate the location of products bearing characters on the packaging and not meeting nutritional guidelines. 1. non-expressive and expressive conduct government regulation of the sale of goods differs from the regulation 315. compare lorillard tobacco co. v. reilly, 533 u.s. 525, 569 (2001), with 44 liq­ uormart, inc. v. rhode island, 517 u.s. 484, 512 (1996). 2012] governmentinterventioninunhealthyfoodpromotions 169 of accurate information about those goods.316 a plurality of the court has stated that: the text of the first amendment makes clear that the constitution presumes that attempts to regulate speech are more dangerous than attempts to regulate conduct .... as a result, the first amendment directs that government may not suppress speech as easily as it may suppress conduct, and that speech restrictions cannot be treated as simply another means that the government may use to achieve its ends.317 this has proven to be true in practice. the court has confirmed that the regulation of conduct with no ex­ pressive component does not implicate the first amendment.318 if it is nec­ essary to explain the meaning of the conduct with speech it would not be considered expressive.319 pure conduct is not protected by the first amendment, and lower courts have found that the basic sale of products does not constitute expressive activity.320 however, the regulation of conduct with an expressive component subjects the restriction to first amendment scrutiny under united states v. 0 'brien.321 a clear cut example of expressive conduct is burning a flag to protest war.322 in lorillard tobacco co. v. reilly, the supreme court analyzed mas­ sachusetts' regulation that banned self-service displays of tobacco and re­ quired that ''tobacco products be placed out of the reach of all consumers in 316. 44 liquonnart, inc., 517u.s. at 512 (plurality opinion). 317. id. (plurality opinion). 318. sorrell v. ims health inc., 131 s. ct. 2653,2664 (2011) ("it is also true that the first amendment does not prevent restrictions directed at commerce or conduct from impos­ ing incidental burdens on speech."); see also arcara v. cloud books, inc., 478 u.s. 697, 706-707 (1986) ("[w]e have subjected such restrictions to scrutiny only where it was con­ duct with a significant expressive element that drew the legal remedy in the first place, as in o'brien, or where a statute based on a nonexpressive activity has the inevitable effect of singling out those engaged in expressive activity, as in minneapolis star. this case involves neither situation, and we conclude the first amendment is not implicated by the enforcement of a public health regulation of general application against the physical premises in which respondents happen to sell books."). 319. see rumsfeld v. forum for academic and institutional rights, inc., 547 u.s. 47, 66 (2006). 320. see philip morris, usa, inc. v. city & cnty. of s.f., no. 08-17649, 345 fed. appx. 276, 2009 u.s. app. lexis 20142, 2009 wl 2873765, at *1 (9th cir. sept. 9, 2009) ("selling cigarettes isn't [protected activity] because it doesn't involve conduct with a 'sig­ nificant expressive element."') (quoting arcara v. cloud books, inc., 478 u.s. 697, 701-02, 706 (1986)). 321. lorillard tobacco co. v. reilly, 533 u.s. 525,569-70 (2001). 322. spence v. washington, 418 u.s. 405 (1974). 170 indiana heal til law review [vol. 9:1 a location accessible only to salespersons.'.j23 the purpose of the regulation was to minimize customer access without proper age verification to prevent minors from obtaining tobacco products. the court found that this. was not a regulation of speech because "massachusetts' sales practices provisions regulate conduct that may have a communicative component, but massa­ chusetts seeks to regulate the placement of tobacco products for reasons unrelated to the communication of ideas."324 however, the court "[a]ssum[ed] that petitioners have a cognizable speech interest in a particu­ lar means of displaying their products,'' and thus analyzed the restriction under the framework for restrictions on expressive conduct developed in united states v. o'brien.325 the.court found that the regulations withstood first amendment scrutiny.326 it is unclear whether massachusetts chal­ lenged the court's assumption that the tobacco companies had a speech in­ terest in displaying their products, but it may be worth challenging this assumption in subsequent cases where the government attempts to regulate the location of products within retail establishments.327 lorillard was the first time the court explicitly applied the 0 'brien test to commercial con­ duct. in the test developed in united states v. 0 'brien, the court laid out the inquiry to analyze government regulations that are unrelated to the sup­ pression of expression but incidentally impinge on speech interests. in this context, the court held that it would find a government regulation is suffi­ ciently justified: if it is within the constitutional power of the govern­ ment; if it furthers an important or substantial gov­ ernmental interest; if the governmental interest is unrelated to the suppression of free expression; and if the incidental restriction on alleged first amendment freedoms is no greater than is essential to the further323. lorillard tobacco co., 533 u.s. at 567 (citing 940 code of mass. regs. §§ 21.04(2)(c)-{d), 22.06(2)(c)-{d) (2000)). 324. ld. at 570 (internal citations omitted). 325. jd. at 569. 326. i d. this was the first time since the advent of the central hudson test that the court expressly applied a standard other than central hudson to commercial expression. in hoffman estates v. flipside, the court found the regulation of commercial conduct (i.e., product location within a store) constitutional. it simply remarked that the conduct fell out of the purview of central hudson, but did not cite o'brien or the time, place, and manner test in its stead. see hoffinan estates v. flipside, 455 u.s. 489, 496 {1982). 327. cf. sorrell, 131 s. ct at 2664 ("it is true that restrictions on protected expression are distinct from restrictions on economic activity or, more generally, on nonexpressive con­ duct it is also true that the first amendment does not prevent restrictions directed at com­ merce or conduct from imposing incidental burdens on speech."). 2012] government intervention in unhealthy food promotions 171 ance of that interest. 328 part one of the 0 'brien inquiry asks whether the enactment of the regulation is within the constitutional powers of the government entity. the ability of states and their political subdivisions to enact public health regu­ lations stems from the traditional police powers allocated to them. 329 this "police power" is recognized in case law dating back to the early 20th cen­ tury as conferring upon state and local governments the ability to enact laws to protect the public's health, safety, and welfare.330 a valid public health rationale will therefore generally pass part one of the 0 'brien test and the court has upheld this justification, explaining: "[t]he first factor of the 0 'brien test is whether the government regulation is within the constitu­ tional power of the government to enact. here, [the city's] efforts to protect public health and safety are clearly within the city's police powers."331 part two of the 0 'brien test seeks to ascertain whether the regulation furthers an important or substantial governmental interest. this part of the "inquiry concerns the fit between the asserted interests and the means cho­ sen to advance them."332 under part two of the o'brien test, the govern­ ment "may employ the means of its choosing" as long as the '"regulation promotes a substantial governmental interest that would be achieved less effectively absent the regulation.'m3 in this context, therefore, the court has held that a government "must be allowed a reasonable opportunity to experiment with solutions to admittedly serious problems.''334 even if a court doubts that the regulation will "greatly'' reduce the problem to be solved,'' 0 'brien requires only that the regulation further the interest" iden­ tified by the govemment.335 it is thus left to the "responsible decisionmak­ er" to determine the "most appropriate method for promoting significant government interests."336 the court's explanation of this second inquiry in o'brien is what affords regulations of conduct more leeway than regula­ tions of speech because strong evidence is required to restrict speech, but 328. united states v. o'brien, 391 u.s. 367, 377 (1968). 329. lawrence 0. gostin, public health law: power, duty, restraint 80-81 (2001). 330. sligh v. kirkwood, 237 u.s. 52, 59 (1915); see also hillsborough cnty. v. auto­ mated mecl. labs, inc., 471 u.s. 707, 719 (1985) ("[t]he regulation of health and safety matters is primarily, and historically, a matter oflocal concern."). 331. city of erie v. pap's a.m., 529 u.s. 277,296 (2000); see also barnes v. glen theatre, inc., 501 u.s. 560, 569 (1991) (the "traditional police power of the states is de­ fined as the authority to provide for the public health, safety, and morals, and we have up­ held such a basis for legislation."). 332. turner broadcasting system v. fcc, 520 u.s. 180,213 (1997). 333. /d. at213-14. 334. city of erie v. pap's a.m., 529 u.s. 277, 301 (2000) (citing renton v. playtime theatres, inc., 475 u.s. at 52). 335. /d 336. turner broadcasting system, 520 u.s. at 218 (quoting united states v. albertini, 472 u.s. 675,689 (1985)). 172 indiana health law review [vol. 9:1 courts are permitted to defer to legislative judgment to regulate conduct. 337 the third requirement for a regulation to pass the 0 'brien test is that the government interest must be unrelated to the suppression of free expres­ sion.338 thus, the regulation must be "content-neutral." this means that the regulation must not target expression according to its content, and the gov­ ernment must also justify the regulation without reference to the content of the regulated speech.339 for example, an ordinance that prohibits the post­ ing of signs on public property regardless of their message is content­ neutral.340 in contrast, a law restricting the transmission of cable television channels dedicated to programming labeled sexually oriented is content­ based. 341 regulations are subject to a stricter analysis than 0 'brien pro­ vides if they are content-based or directed at and restrict speech instead of conduct. 342 (in the commercial speech context, such a restriction would be subject to central hudson analysis.343) 337. see brown v. entm't mercbs. ass'n. 131 s. ct. 2729,2738 (2011) ("rather, rely­ ing upon our decision in turner broadcasting system, inc. v. fcc, 512 u.s. 622 (1994), the state claims that it need not produce such proof because the legislature can make a predic­ tive judgment that such a link exists, based on competing psychological studies. but reliance on turner broadcasting is misplaced. that decision applied intermediate scrutiny to a con­ tent-neutral regulation. id. at 661-662, 114 s. ct. 2445. california's burden is much higher, and because it bears the risk of uncertainty ... ambiguous proof will not suffice."); turner broadcasting system, 512 u.s. at 665 ("we agree that courts must accord substantial defer­ ence to the predictive judgments of congress. sound policymaking often requires legislators to forecast future events and to anticipate the likely impact of these events based on deduc­ tions and inferences for which complete empirical support may be unavailable.") (internal citation omitted); see also lorillard tobacco co. v. reilly, 533 u.s. 525, 558 (2001) (find­ ing the state passed the third prong of central hudson by relying on substantial amount of evidence); 44 liquormart, inc. v. rhode island, 517 u.s. 484, 505 (1996) (government fail­ ing prong three because it did not present evidence that its price-advertising ban would sig­ nificaritly reduce alcohol consumption). 338. united states v. o'brien, 391 u.s. 367, 377 (1968). 339. boos v. barry, 485 u.s. 312, 320 (1988) (citing va pharmacy bd. v. va citizens consumer council, inc., 425 u.s. 748, 771 (1976)). 340. members of the city council of los angeles v. taxpayers for vincent, 466 u.s. 789,805-807 (1984). 341. united states v. playboy, 529 u.s. 803, 813 (2000) (because the act designated cable channels based on the content of the programming, it could not be analyzed under 0 'brien, and instead was subject to strict scrutiny.); see also frisby v. schultz, 487 u.s. 474, 481 (1988) ("for the state to enforce a content-based exclusion it must show that its regula­ tion is necessary to serve a compelling state interest and that it is narrowly drawn to achieve that end.") (quoting perry educ. ass'n. v. perry local educ. ass'n, 460 u.s. 37,45 (1983)). 342. texas v. johnson, 491 u.s. 397 (1989); see also spence v. washington; 418 u.s. 405 (1974). in the realm of traditional political speech, such measures would be subject to strict first amendment scrutiny. see, e.g., texas v. johnson, 491 u.s. 397, 412-14 (1989) (holding that the government may not prohibit expression of an idea merely because it finds the idea offensive; therefore, johnson's conviction for flag burning in a show of political expression and protest must be subject to .. the most exacting scrutiny" rather than 0 'brien's more lenient standard). 343. see, e.g., lorillard tobacco co., 533 u.s. at 567 ("by contrast to justice stevens, we do not believe this regulation can be construed as a mere regulation of conduct under united states v. 0 'brien. to qualify as a regulation of communicative action governed by 20 12] government intervention in unhealthy food promotions 173 the final inquiry under 0 'brien is to determine whether any inci­ dental restrictions on alleged first amendment freedoms are no greater than necessary to further the government's interest. the court confirmed that when it evaluates "a content-neutral regulation which incidentally burdens speech, [it] will not invalidate the preferred remedial scheme because some alternative solution is marginally less intrusive on a speaker's first amendment interests.'.j44 therefore, as long "as the means chosen are not substantially broader than necessary to achieve the government's interest, .. . the regulation will not be invalid simply because a court concludes that the government's interest could be adequately served by some less-speech­ restrictive alternative.''345 the court thus looks to whether the regulation is narrowly tailored to eliminate the harms the government seeks to rectify, without significantly restricting a substantial quantity of speech that does not create the same harms. 346 part four of 0 'brien requires the court to en­ sure that the government properly confined the breadth and burden of the regulation. 347 2. other standards to regulate conduct it is important to note that in lorillard, the supreme court analyzed massachusetts' regulation of self-service displays not only in light of 0 'brien, but also under the standard derived from cases involving the regu­ lation of the ''time, place and manner" of protected speech. prior to lo­ rillard, the court had noted the essential equivalence of the 0 'brien "conduct" test and the time, place, and manner analysis, observing that the two regimes "embody much [of] the same standards."348 the time, place and manner test is often applied to zoning cases349 or cases involving rethe scrutiny outlined in o'brien, the state's regulation must be unrelated to expression. here, massachusetts' height restriction is an attempt to regulate directly the communicative impact of indoor advertising.'') (internal citations omitted). · 344. turner broad. sys., inc. v. fcc, 520 u.s. 180, 217-18 (1997). 345. jd. at 218 (quoting ward v. rock against racism, 491 u.s. 781,800 (1989)). 346. id. at 216. 347. clark v. cmty. for creative non-violence, 468 u.s. 288, 299 (1984); see also ward v. rock against racism, 491 u.s. 781 (1989). 348. barnes v. glen theatre, inc., 501 u.s. 560, 566 (1991); see also clark v. cmty. for creative non-violence, 468 u.s. 288,299 n.8 (1984). 349. the time, place and manner test has also been applied to zoning ordinances, which are a form of content-neutral regulation. in his concurring opinion in lorillard, justice thomas distinguished valid zoning restrictions from those struck down in the case. massa­ chusetts had argued that the 1,000 feet restrictions were "'zoning-type restrictions' that should receive 'the intermediate level of scrutiny traditionally associated with various forms of'time, place, and manner' regulations."' lorillard tobacco co., 533 u.s. at 573 (thomas, j., concurring). however, the court analyzed them under central hudson and found that they failed prong four of that test thomas explained that the regulations could not be con­ sidered valid zoning laws, and should not be analyzed under the time, place, and manner test because they were not content-neutral. id. (thomas, j., concurring) (citing ward v. rock against racism, 491 u.s. 781, 791-96 (1989)). the 1000 feet restriction was based on the billboards' tobacco-based content the cornerstone of valid time, place, and manner regula174 indiana health law review [vol. 9:1 strictions on speech on government property.350 under this test, the gov­ ernment may impose reasonable restrictions "on the time, place, or manner of protected speech, provided the restrictions 'are justified without refer­ ence to the content of the regulated speech, that they are narrowly tailored to serve a significant governmental interest, and that they leave open ample alternative channels for communication of the information. "'351 the court's analysis of the tobacco display regulations drew from principle and precedent in both lines of cases. apart from the ban on self-service displays of tobacco products up­ held in lorillard tobacco co. v. reilly, few cases directly address the regu­ lation of product location within a store in the context of the first amendment. in one of the few, village of hoffman estates v. flipside, hoffman estates, inc., a store called flipside challenged an ordinance regu­ lating the sale of the drug paraphernalia within the proximity of literature about illegal drug use because it wanted to continue placing certain items at the point of purchase for fear of shoplifting. 352 the court held that "insofar as any commercial speech interest is implicated here, it is only the attenuat­ ed interest in displaying and marketing merchandise in the manner that the retailer desires. we doubt that the village's restriction on the manner of marketing appreciably limits flipside's communication of information."353 the court found that the ordinance did not restrict commercial speech, but rather regulated "business behavior,'' and thus it did not subject the ordi­ nance to the central hudson test. 354 although the court did not cite o'brien in flipside, the analysis in the case is similar to that in lorillard. in both cases, the court acknowledged the existence of a potential commercial speech interest. however, in lo­ rillard, the court upheld the ban on self-service displays as a regulation of conduct under o'brien, whereas in flipside, the court simply stated that the law "does not reach constitutionally protected conduct.'.j55 this likely reflects the evolution of the commercial speech doctrine over time. since the inception of the commercial speech doctrine, the court has increasingly interpreted the first amendment to provide more stringent protection to commercial expression over the years. 356 tions is their content-neutrality. 350. clark v. cmty. for creative non-violence, 468 u.s. 288, 293 (1984); see also heffron v. int'l soc'y for krishna consciousness, inc., 452 u.s. 640, 647 (1981); galena v. leo~e, 638 f.3d 186, 199 (3d cir. 2011). 351. ward v. rock against racism, 491 u.s. 781, 791 (1989) (quoting clark v. cmty. for creative non-violence, 468 u.s. 288,293 (1984)). 352. vill. ofhoffinan estates v. flipside, hoffinan estates, inc., 455 u.s. 489 (1982). 353. id at 496 (emphasis omitted). 354. id at 496-499. 355. id at497. 356. see, e.g., sorrell v. ims health inc., 131 s. ct. 2653, 2685 (2011) (breyer, j., dissenting) (refening to lack of precedent for subjecting the type of regulation at issue to the central hudson test and expressing concern that the majority opinion will open "a pandora's box of first amendment challenges to many ordinary regulatory practices that may only 2012] government intervention in unhealthy food promotions 175 c. constitutional analysis of the in-store regulations there are two practical options that can be implemented at a state or local level that the government could consider in addressing in-store pro­ motions: regulate the location of products not meeting nutritional guide­ lines or products bearing characters on the packaging that do not meet nutritional guidelines. 357 within the retail environment, the key locations to consider are shelf level and location, special displays such as end-cap dis­ plays, and check-out aisles. 1. regulating product location based on nutritional criteria the government could determine that it wants to regulate the location of unhealthy food products by designating products solely according to their nutritional profiles. because there is no expressive component to nu­ tritional profiles, it would be difficult for industry to argue that this is a reg­ ulation of commercial expression. the government could enact strong nutritional guidelines for foods to be placed in specific areas such as at the check-out or in the bulk displays located at the end of aisles. the govern­ ment could likewise regulate the location of specific products according to nutritional profile, such as sugar-sweetened beverages, so that they must be placed in destination locations in the back of the store. if the government were to regulate the location of food and beverage products within a retail establishment based solely on nutrition criteria, the government would have a strong argument that this is a pure regulation of conduct, not implicating the first amendment.358 requiring retailers to alter the location of a product within the store based solely on a non­ expressive element such as nutrition criteria should be considered a regula­ tion of pure conduct. the ninth circuit upheld san francisco's ban on pharmacies selling tobacco products, explaining that selling cigarettes is not protected expres­ sive activity because "[i]t doesn't even have 'an expressive component. ".359 incidentally affect a commercial message''). 357. a regulation based only on the use of character would be over-inclusive to address nutrition. characters may be found on healthy products or products· only for adults or non­ food products. cf bad frog brewery, inc. v. n.y. state liquor auth.,134 f.3d 87,92 (2d cir. 1998) (reminding the parties that other characters have been used to market beer, includ­ ing the budweiser frogs, spuds mackenzie and the bud-ice penguins, and rejecting the advertising restrictions). 358. arcara v. cloud books, inc., 478 u.s. 697, 706-707 (1986) ("[w]e have subject­ ed such restrictioti.s to scrutiny only where it was conduct with a significant expressive ele­ ment that drew the legal remedy in the first place, as in 0 'brien, or where a statute based on a nonexpressive activity has the inevitable effect of singling out those engaged in expressive activity, as in minneapolis star. this case involves neither situation. and we conclude the first amendment is not implicated by the enforcement of a public health regulation of gen­ eral application against the physical premises in which respondents happen to sell books."). 359. philip morris usa, inc. v. city and cnty. ofs.f., 345 fed. appx. 276, 277 (9th 176 indiana heal1h law review [vol. 9:1 the ninth circuit held that the sale of an item is pure conduct and not pro­ tected by the first amendment.360 in the context of private litigation, where the court is not analyzing a government restriction on speech under the first amendment, but rather analyzing private parties' .actions implicating another party's communica­ tion interests, courts have found that shelf placement and location within retail environments are not speech. in the antitrust context, courts have found that moving a product to a location a manufacturer deems less ideal does not implicate the company's ability to communicate with consum­ ers.361 in the context of a trademark infringement and false advertising law­ suit, a district court found that a retailer's display of a product under the wrong name and in the incorrect shelf location was not actionable because the display of products in a certain location does not constitute "commercial advertising or promotion.'.362 the eleventh circuit affirmed the district court's opinion, in which the district court explained: [p]roduct placement is not commercial speech .... it is difficult to see how merely displaying products on a store shelf qualifies as speech .... if product place­ ment such as that ·alleged here was sufficient to con­ stitute commercial advertising or promotion, grocery store aisles, with competing products displayed one after another and often inadvertently placed over an cir. 2009) (quoting talk of the town v. dep't of fin. & bus. servs., 343 f.3d 1063, 1069 (9th cir. 2003) (citing arcara, 478 u.s. at 701-02, 706 (1986)); cf. lorillard tobacco co., 533 u.s. at 550. 360. cf. ginsberg v. n.y., 390 u.s. 629, 638 (1968) (although decided under the first amendment, and not as a regulation of conduct, the supreme court noted that governrilent has power "to control the conduct of children" that "reaches beyond the scope of its authori­ ty 9ver adults.''). 361. antitrust lawsuits provide an interesting lens through which to view the food in­ dustry's concerns with respect to shelf location. for example, in r.j. reynolds tobacco co. v. philip mo"is usa, inc., 199 f. supp. 2d 362 (m.d. n.c. 2002), qff'd, 67 fed. appx. 810 (4th cir. 2003), competing tobacco companies sued philip morris ("pm") for anticompeti­ tive behavior under the sherman action. the relevant portions of the complaint alleged that pm was paying retailers for actvantageous signage space and displays of their products, which plaintiffs alleged restricted the tlow of their information to consumers. id. at 380-81. the court found that, although retailers that sign onto pm's program do give more advanta­ geous display and sign space to pm products, plaintiffs were not excluded from posting signs or displaying their products in alternative locations in the store, (or even entering in their own agreements with ret8ilers for more advantageous visibility). the court found as a matter of law that pm's practice .. does not unreasonably deny consumers needed infor­ mation." /d. at 396. importantly, the court concluded that plaintiffs ability to communicate in other places within the swre, other than the most prime visibility locations, did not unrea­ sonably deny consumers commercial information .. see also el aguija food prods., inc. v. gruma corp., 301 f. supp. 2d 612 (s.d. tex. 2003), qff'd, 131 fed. appx. 450 (5th cir. 2005). 362. optimum techs., inc. v. home depot usa, inc ... no. 1:04-cv-3260-twt, 2005 u.s. dist. lexis 34776, at *19-20 (n.d. ga. december 5, 2005), qff'd, 217 fed. appx. 899 (11th cir. 2007). 20 12] government intervention in unhealthy food promotions 177 incorrect store tag, would constitute actionable false advertising. 363 these cases confirm that courts accept the proposition that the place­ ment of products in locations not considered ideal to the manufacturer does not cut off their ability to communicate with customers. this measure is applicable and legally defensible for unhealthy food products to protect children without implicating commercial speech.364 by locating items of poor nutritional value out of checkout aisles or end-cap displays,365 and placing healthier items (or non-food items) in their place, such an ordinance leaves open alternative channels for vendors to sell and convey the same information about their products. likewise, such re­ location does not impede consumers' access to these exact same products because they would be located elsewhere. in the store.366 once outside the purview of the first amendment, the government must only show that the regulation is rationally related to a legitimate gov­ ernment interest. 367 here, this would be a valid regulation of "commercial transactions," 368 or "business behavior,'o369 that rests on a rational basis and should be upheld under this criterion. 2. regulating product location based on nutritional criteria and character use the second method to positively influence the food choices by chil363. id. (internal citations omitted). 364. see also bad frog brewery v. n.y. state liquor auth., 134 f.3d 87, 98-99 (2d cir. 1998). under a discussion of why a commercial speech restriction failed prong four of the central hudson test, the second circuit suggested in store regulation of the location of the product would have been a viable alterative to regulating speech. the second circuit did not analyze its suggestion, but it is worth noting the measure it found was available to the state: ''to whatever extent [the state] is concerned that children will be harmfully exposed to the bad frog labels when wandering without parental supervision around grocery and con­ venience stores where beer is sold, that concern could be less intrusively dealt with by plac­ ing restrictions on the permissible locations where the appellant's products may be displayed within such stores." /d. at 101. 365. gale group. confection detection: creative merchandising works food candy stores-within-a-store concept offer colorful, interactive displays brief article dsn retail­ ing today, june 24, 2002 ("the key to location is realizing candy is an impulse purchase. it reacts more to a display than it does to price.') 366. lorillard tobacco co., 533 u.s. at 569-70. 367. ysursa v. pocatello educ. ass'n, 172 l. ed. 2d 770, 778 (2009) ("given that the state has not infringed the unions' first amendment rights, the state needs only demonstrate a rational basis to justify the [law]. j. 368. sorrell, 131 s. ct. 2653 at 2675 (breyer dissenting) ("'[r]egulatory legislation affecting ordinary commercial transactions js not to be pronounced unconstitutional' if it rests 'upon some rational basis within the knowledge and experience of the legislators."') (quoting united states v. carotene products co., 304 u.s. 144, 152 (1938). 369. flipside, 455 u.s. at 499. 178 indiana health law review [vol. 9:1 dren would be to regulate the location of food products of poor nutritional quality also bearing characters to address the poor nutrition-related beliefs and behaviors of children. by addressing the use of characters on unhealthy food products, the regulation would be directly moving the problem prod­ ucts to make the default choice the healthy choice and allow adults shop­ ping with children to avoid specific areas of the retail environment. this would not be suppressing speech but simply moving it to another location. it would also not address more character use than essential. thus, charac­ ters on healthy products (such as carrots) would not be regulated. 370 the regulation could likewise exclude characters on products only legally pur­ chasable by adults, such as beer, in order to address the harm the govern­ ment seeks to rectify, without restricting speech that does not create the same harm. 371 regulating the location of products according to the nutrition profile and use of characters may spur a legal challenge by retailers and/or manu­ facturers, who would argue that the characters are a form of commercial speech and that the regulation violates their first amendment rights of commercial expression. the first question is whether the use of cartoon characters is a form of commercial speech. section 5.8.1., above, analyzed the use of characters on unhealthy food products under the theory that they are deceptive to children and thus not protected by the first amendment. the government would want to assert the same argument here as well. if a court disagrees, it would find that the characters are a form of commercial expression. the second question is whether regulating the location of the products bearing such characters interferes with the industry's first amendment rights of expression. the government has a valid argument that simply moving products within a store is pure regulation of conduct and could cite the precedent discussed above. however, the industry would argue that designating a product according to the use of characters is content-based. if a court did not agree that this was a pure regulation of conduct, the closest precedent to the proposed regulation here would be the ban on self-service displays upheld in lorillard as a regulation of expressive conduct. 372 like 370. a regulation aimed solely at moving products with illustrations would seem to be ill-tailored because it would implicate healthy products (such the "sun-maid girl" on raisins, or carrots with characters), products for adults, thus not furthering the government's public health interests, so could be considered overbroad. 371. turner broadcasting system v. fcc, 520 u.s. 180, 216 (1997); see, e.g., bad frog brewery, 134 f .3d at 92 (the court reminded the parties that other characters have been used to market beer, including the budweiser frogs, spuds mackenzie and the bud-ice penguins and rejected the advertising restrictions). 372. lorillard tobacco co. v. reilly, 533 u.s. 525, 567 (2001) (citing 940 code of mass. regs. §§ 21.04(2)(c}-{d), 22.06(2)(c}-{d) (2000)) (the regulations' stated purpose was to minimize customer access without proper age verification to prevent minors from obtaining tobacco products.). 2012] government intervention in unhealthy food promotions 179 in lorillard, the state would be seeking to regulate conduct ''that may have a communicative component," but altering the location of the products within the retail establishment "for reasons unrelated to the communication of ideas."373 under this precedent, a court should analyze the retail regula­ tion under o'brien.314 a. analysis under 0 'brien under 0 'brien analysis, a court will first ask if such regulations are within the constitutional power of the government. 375 state and local gov­ ernments can regulate retail establishment to further public health under their traditional police power.376 for example, in the tobacco context, gov­ ernments often require tobacco retailers to be licensed and to agree to cer­ tain conditions, such as not selling cigarettes to children, in order to operate.377 this proposed regulation of the retail environment would be similar public health regulations of retailers enacted as part of the state and local governments' police power. second, courts ask if the regulations will further an important or sub­ stantial governmental interest. 378 in the case of retail food regulations, the government would have several rationales for locating unhealthy items with characters in destination locations. the state has an interest in protecting children from overreaching by commercial entities and correcting children's poor nutrition-related beliefs and behaviors that result from such overreach­ ing. 379 the regulation seeks to support public health by making the loca­ tions most frequented in the store supportive of making healthy choices, thus encouraging healthy default choices. in addition, by requiring un­ healthy products directed at children to be placed in destination locations, this would enable adults to avoid the products when shopping with children, thereby bolstering parents and guardians in their roles as nutritional gate­ keej>ers. 380 the government has a valid argument that these public health and consumer protection rationales will be furth~red by the regulations within retail establishments. in this context, the court has held that under 0 'brien, 373. jd. at 570 (internal citations omitted). 374. /d. at 569. 375. united states v. o'brien, 391 u.s. 367, 377 (1968). 376. city of erie v. pap's a.m., 529 u.s. 277, 296 (2000); gostin, supra note 337, at 282-83. 377. see, e.g., new york laws: new york city administrative code: tobacco product regulationact. §§ 17-616-17-626. 378. o'brien, 391 u.s. at 377. 379. bd. oftrs. of the state univ. ofn.y. v. fox, 492 u.s. 469 (1989). 380. bellotti v. baird. 443 u.s. 622, 634 (1979); fcc v. pacifica foundation, 438 u.s. 726,749 (1978) (quoting ginsberg v. new york. 390 u.s. 629) (the government's interest in "supporting 'parents' claim to authority in their own household'" justifies restricting other­ wise protected expression). 180 indiana health law review [vol. 9:1 a government "must be allowed a reasonable opportunity to experiment with solutions to admittedly serious problems. "'381 even if a court doubts that the regulation will "greatly'' reduce the problem to be solved, "0 'brien requires only that the regulation further the interest" identified by the gov­ ernment. 382 based on the research delineated above, the government can establish that the regulations would further these public health and consum­ er protection interests. third, the court will ask if the governmental interest is unrelated to the suppression of free expression;383 this means that the regulation must not target expression according to its content and the government must also justify the regulation without reference to the content of the regulated speech. 384 industry might argue that the regulation is not content-neutral because it incorporates the use of characters, which it considers to be pro­ tected speech. the government would argue that regulation does not target expression because it is not disagreeing with any message that the manufac­ turer is attempting to convey by using characters on its packaging or any message the retailer may have by locating the products in their originallo. cations. rather, the governtnent would simply be seeking to move these messages to another location within the same retail establishment for the reasons delineated in the second inquiry above, thereby moving any expres­ sive component to a different location-not to suppress the expression it­ self. the industry would likely challenge the content neutrality of the regulation by arguing that designating a product by reference to the use of a cartoon character would be content-based. it is worth analyzing to what extent this is a valid argument under the 0 'brien test. (/) content-neutrality in lorillard the court did not expand on the content-neutrality of the regulation upheld under o'brien. apart from lorillard, the court had not applied 0 'brien to expressive commercial conduct but the closest case on point is flipside v. hoffman estates where the court upheld the city's ordi­ nance which moved the location of commercial products within the retail environment. the ordinance in that case "licenses and regulates the sale of items displayed 'with' or 'within proximity of' 'literature encouraging ille­ gal use of cannabis or illegal drugs, • . . . . [and] drug-related designs or names on cigarette papers may subject those items to regulation." howev381. city of erie v. pap's a.m., 529 u.s. 277, 301 (2000) (citing renton v. playtime theatres, inc., 475 u.s. 41, 52 (1986) (quoting young v. american mini theatres, 427 u.s. 50, 71 (1976) (plurality opinion))). 382. id. . 383. o'brien, 391 u.s. at377. 384. boos v. barry, 485 u.s. 312, 320 (1988) (quoting virginia pharmacy bd. v. vir­ ginia citizens consumer council, inc., 425 u. s. 748, 771 (1976)). 20 12] government intervention in unhealthy food promotions 181 er, the court found that, ''the village does not restrict speech as such, but simply regulates the commercial marketing of items that the labels reveal may be used for an illicit purpose." 385 thus the court recognized that the method to determine which commercial·speech was subject to the ordinance was to look at the content of the label.386 the purpose of the regulation was not to limit the speech but move it to a different location. on this latter point, the court concluded that, ''insofar as any commercial speech interest is implicated here, it is only the attenuated interest in displaying and mar­ keting merchandise in the manner that the retailer desires. we doubt that the village's restriction on the manner of marketing appreciably limits flip­ side's communication ofinformation." 387 based on this case, the government has a good argument that moving the location of items defined through nutrition profile and the use of charac­ ters should withstand first amendment scrutiny. the court's commercial speech jurisprudence has . evolved since flips ide, so a comparison to two cases concerning core speech (which is strictly protected) can also flesh out the concept of content-neutrality. in boos v. barry, the court found the restriction at issue to be content-based. in that case washington, d.c. at­ tempted to prohibit individuals from displaying signs 500 feet from foreign embassies if the sign brought that foreign government into ''public disre­ pute!.j88 the court found this regulation to be content-based because it prohibited political speech based on the content of the speech in a public forum. 389 the court noted that the city attempted to justify the regulation based on the need to protect the "dignity of foreign diplomatic person­ nel. "390 disregarding the forum and political aspect of the speech, the case 385. viii. ofhoffinan estates v. flipside, 455 u.s. 489, 496 (1982). 386. see also hill v. colorado, 530 u.s. 703, 721-22 (2000) ("it is common in the law to examine the content of a communication to determine the speaker'& purpose. whether a particular statement constitutes a threat, blaclnnail, an agreement to fix prices, a copyright violation, a public offering of securities, or an offer to sell goods often depends on the pre­ cise content of the statement. we have never held, or suggested, that it is improper to look at the content of an oral or written &tatement in order to determine whether a rule of law applies to a course of conduct. with respect to the conduct that is the focus of the colorado statute, it is unlikely that there would often be any need to know exactly what words were spoken in order to determine whether 'sidewalk counselors' are engaging in 'oral protest, education, or counseling' rather than pure social or random conversation. theoretically, of course, cases may arise in which it is necessary to review the content of the statements made by a person approaching within eight feet of an unwilling listener to determine whether the approach is covered by the statute. but that review need be no more extensive than a determination of whether a general prohibition of 'picketing' or 'demonstrating' applies to innocuous speech. the regulation of such expressive activities, by definition, does not cover social, random, or other everyday communications .... nevertheless, we have never suggested that the kind of cursory examination that might be required to exclude casual conversation ftom the coverage of a regulation of picketing would be problematic."). 387. viii. ofhoffinan estates, 455 u.s. at496. 388. boos v. barry, 485 u.s. 312,315 (1988). 389. id at 319. 390. /d. at 321. 182 indiana health law review [vol. 9:1 nonetheless addressed a ban on content-based political expression. even in the context of political expression the outcome could have been different if the ordinance just required the protesters with such signs to move to another location outside the embassies. the case of hill v. colorado stands for this propositioji. 391 in hill v. colorado, the court sought to determine the constitutionality of a statute prohibiting people from approaching one another within 100 feet of the entrance to any health care facility to engage in protest or educa­ tion. the principal inquiry in the court's analysis of content-neutrality was to determine "'whether the government has adopted a regulation of speech because of disagreement with the message it conveys. "'392 the court found that the statute was content-neutral because it did not regulate speech, but rather regulated ''the places where some speech may occur;" it was not adopted because the government disagreed "with the message it conveys" because it equally applied to all demonstrators regardless of the view­ point.393 the court specifically stated: "we have never held, or suggested, that it is improper to look at the content of an oral or written statement in order to determine whether a rule of law applies to a course of conduct. "394 in the case of regulation of products within retail environments, the government would likewise not be regulating speech but rather regulating the place where some speech may occur. second, the government does not disagree with a message that a cartoon character may indicate but simply requires a "cursory examination" of the package to identify which packages fall under the ordinance. 395 the regulation would cover all products with a 391. the majority in colorado v. hill noted that the persons going into the health care center would be unwilling listeners and compared them to a captive audience. captive audi­ ence jurisprudence is based on a privacy interest, and in this case it was the access to health care. hill, 530 u.s. at 718. although a similar privacy interest would not likely attach to a supermarket experience, an analogy could be drawn because going into a food store is a necessity to obtain food and further, in order to purchase food. customers must exit through a check-out aisle which is lined with items known to induce impulse purchases. erznoznik v. city of jacksonville, 422 u.s. 205, 209, 210-11 (1975); see also lehman v. city of shaker heights, 418 u.s. 298, 302 (1974). even if a court does not perceive customers to be a cap­ tive audience, this is how retailers view them. restrictions on traditional speech have been upheld when the listener has been considered captive and ooable to avoid offensive speech. in lehman, the court found that riders on the city's public transit system were a captive audience, and the city could reject political advertisements on its vehicles. the court found that the '"streetcar audience is a captive audience. it is there as a matter of necessity, not of choice."' /d. at 302. likewise, a food store is a place one goes out of necessity and the checkout aisle is a place one must enter and cannot avoid in order to purchase food necessi­ ties. in the school context the court has recognized that children are a captive audience and has afforded increased protection from exposure to sexually explicit, indecent, or lewd speech. see bethel sch. dist. v. fraser, 478 u.s. 675,684 (1986). 392. hill, 530 u.s. at 718 (quoting ward v. rock against racism, 491 u.s. 781, 791 (1989)). 393. id at 719-20. 394. !d. at 722. 395. !d. 2012] government intervention in unhealthy food promotions 183 character that do not meet the nutritional guidelines, not differentiating among potential "messages" that the character is cute, funny or "creepy."396 because the character restriction is based. on nutritional guidelines and not on the type of character, the regulation would not be choosing among dif­ ferent types of characters or messages that different characters may be at­ tempting to send from an industry perspective. one purpose behind the ban on self-service displays in lorillard to­ bacco co. v. reilly, was to move tobacco products to areas where children could not access them.397 similarly, the supermarket restrictions would be moving harmful products to different locations so adults accompanied by children can avoid if they so wish. the second circuit suggested this exact measure to protect children in the retail environment from seeing .a "vulgar" character on beer labels: [t]o whatever extent [the state] is concerned that children will be harmfully exposed to the bad frog labels when wandering without parental supervision around grocery and convenience stores where beer is sold, that concern could be less intrusively dealt with by placing restrictions on the permissible locations where the appellant's products may be displayed with­ in such stores. 398 the court's reasoning in tennessee secondary school v. brentwood is also relevant.399 the court recognized the need to protect "impressionable middle school" children from overreaching by a letter from a sports coach, as a "hard-sell tactic.'..wo in the case of a letter, the parent retrieves the mail and could control whether to give the middle school child the letter. in the supermarket, parents cannot similarly shield their children from all food packaging. in brentwood, the letter came from a coach seeking to solicit participation in football-the court found that this "could lead to exploita­ tion, distort competition between high school teams, and foster an environ­ ment in which athletics are prized more highly than academics. "401 in the supermarket, the characters are certainly a hard-sell tactic because they in­ duce purchase requests by children who do not even know what is in the packaging and also influence children to prefer the food with the character. 396. derek thompson, burger king's horrible, creepy ad campaign isn't working, the atlantic, june 22, 2009, http://www.theatlantic.comlbusinesslarchive/2009/06/burger­ kings-horrible-creepy-ad-campaign-isnt-working/19870/. 397. lorillard tobacco co., 533 u.s. at 567. . 398. bad frog brewery v. n.y. state liquor auth., 134 f.3d 87, 101 (2nd cir. 1998). 399. tenn. secondary scb. athletic ass'n v. brentwood acad., 551 u.s. 291 (2007). 400. ld. at 296. 401. tenn. secondary sch. athletic ass'n v. brentwood acad., 551 u.s. 291, 300 (2007). 184 indiana health law review [vol. 9:1 a similar argument can be made that this fosters an environment where packaging is "prized more" than the food contained therein, and especially healthy nutritious food. the government bas a valid argument that the regulation is content-neutral and the court should proceed to the fourth in­ quiry under o'brien b. 0 'brien inquiry continued under the final inquiry under o'brien, the government must show that any incidental restriction on alleged first amendment freedoms is no great­ er than is essential to further that interest.402 even if the manufacturers and retails bad some kind of expressive interest in the original location of the products, by placing the products in the new location within the same retail establishment, any incidental restriction on alleged first amendment free­ doms would be no greater than is essential to further that interest.403 this paper explored several other options in order to address the problem of character marketing on unhealthy food and beverages. these regulations of conduct are the least restrictive available to state governments, while also addressing the problem sought to be rectified. in the food context, the government bas evidence that regulating the location of products does alter consumer behavior. 404 the government has a good argument that the retail establishment regulations are narrowly tai­ lored to eliminate the harms the government seeks to rectify, without signif­ icantly restricting any quantity of speech that does not create the same harms. 405 thus even assuming retailers and manufacturers have a cogniza­ ble speech interest in the original means or location of displaying· their ·products, the ordinances should pass this part of the test because the expressive components are simply being moved to a different location and are not being suppressed.406 given that the retail food environment fosters pur­ chase of foods high in calories and low in nutrients and that some of the worst foods are placed where impulse purchases are most likely, a strong argument can be made that government bas a compelling interest in chang­ ing this environment, particularly as it affects children. 407 402. united states v. o'brien, 391 u.s. 367, 377 (1968). · 403. /d 404. see, e.g., gale grp. confection detection: creative merchandising works -food -candy stores-within-a-store concept coffer coloiful, interactive displaysbrief article dsn retailing today (june 24, 2002), ht1p://findartic1es.comlp/articleslmi_m0fnp /is_12_ 41/ai_87776891/ (''the key to location is realizing candy is an impulse purchase. it reacts more to a display than it does to price. j. 405. turner broad. sys. v. fcc, 520 u.s. 180,216 (1997). 406. lorillard tobacco co. v. reilly, 533 u.s. 525,569 (2001). 407. brown v. entm't merchs. ass'n, 131 s. ct. 2729, 2762 (2011) (breyer j. dissent­ ing) (the "'regulatio[n] of communication addressed to [children] need not conform to the requirements of the [f]irst [a]mendment·in the same way as those applicable to adults."') (quoting ginsberg v. new york. 390 u.s. 629, 638 n.6, (1968) (quoting thomas emerson, 2012] government intervention in unhealthy food promotions 185 vii. conclusion the food retail environment does not support healthy choices and in­ duces children to request and think they prefer unhealthy. food because of the use of characters and other promotions on packaging and throughout the store. the government may determine that it has an interest in addressing this environment based on its interests in advancing public health, protect­ ing children from manipulation and commercial exploitation, and support­ ing parents' role in child-rearing. based on the best science evidence and within the constraints of the first amendment, two viable methods to ad­ dress this environment emerge. the federal government is in the best position to enact a restriction on the use of characters on packaging for food and beverages that do not meet strong nutritional guidelines. the government can argue that the use of characters on unhealthy food is deceptive and misleading as directed at children and thus not protected under the first amendment. if a court does not accept this argument, the government would have a strong argument that a well-defined restriction would survive scrutiny under the full central hudson test. concurrently, or in the absence of federal regulation, state and local governments could regulate the location of such products within retail es­ tablishments that do not meet certain nutrition profiles or regulate the loca­ tion of the same unhealthy products that also bear characters on the packaging. the former should be considered and upheld as a pure regula­ tion of conduct and the latter should be upheld under the test developed in o'brien. government regulation may be warranted in light of the emerging ev­ idence that food retail and package promotions directed at children are pri­ marily for unhealthy food, and this environment is not being addressed by the industry despite self-regulation in other areas. to date government ac­ tion has largely focused on deceptive or misleading claims on food and beverage packaging directed at adult consumers. industry has treated chil­ dren as active consumers for decades and research reveals that this is nega­ tively impacting children's beliefs and behaviors associated with unhealthy food products. public health and government entities should address this environment by responding to the true role children play in the marketplace. in this way, the government can directly address deceptive and misleading practices targeting child-consumers and enact protective measures based on the most recent science. toward a general theory of the first amendment, 72 yale l. j. 877, 939 (1963))). implications of neuroscience advances in tort law: a general overview betsy j. grey * i. intentional acts .......................................................... 673 ii. negligent acts and the reasonable person .......... 678 iii. substantiating emotional harm ............................. 684 iv. the psychotherapist’s duty to warn ..................... 690 v. conclusion ................................................................... 693 if you look at tort decisions in the last couple of decades and ask what role neuroscience had, the answer is almost none. but we are getting closer to the point at which advances in neuroscience will inform various issues involved in tort law. in this essay, i will focus on four issues. the first two examine the broad outlines of judging non-accidental (intentional) and accidental behavior, including the concepts of choice and duty. the second two focus more specifically on two negligence torts – inflicting emotional harm and requiring psychotherapists to report a dangerous patient to others – to illustrate how advances in neuroscience may influence those torts. assuming that science can inform these legal issues, the question remains whether removing or reducing the significance of science or empirical questions will (or should) change the legal landscape in tort law, or whether other values or moral judgments are at stake in the area. the legal issues in tort law are normative ones, addressing how we should regulate our lives in a complex society. as advances occur, we will need to address whether the new neuroscience will shift paradigms in tort law.1 at the very least, a step forward in * professor of law and alan a. matheson fellow, sandra day o’connor college of law at arizona state university. i thank bob dauber, joel nomkin, and mary sigler for their insightful suggestions. i am also grateful to the hall center for law and health, robert h. mckinney school of law at indiana university, where i presented this paper. i thank andrew vribicek for his research assistance. 1 other commentators, such as jean eggen, eric laury and adam kolber, have explored these issues in the context of tort law, and i draw on their work, as well as my own, in raising some of these issues. see http://dx.doi.org/10.18060/3911.0005 672 indiana health law review vol. 12:2 empirical science might enable the law to be clearer about its normative views. we use various theoretical justifications to support tort law, but most trace to two basic ideas: instrumentalist concerns and corrective justice concerns.2 with the former, we try to encourage the most economically efficient way for individuals and entities to behave in a given situation.3 we look beyond the two parties involved in the lawsuit and towards promoting the social good generally.4 with the latter, we try to rectify the inequity resulting from one actor wrongfully harming another.5 justice here means shifting the loss suffered by the injured party to the party responsible for the injury.6 to promote both these goals, we empower individuals or entities to sue another person or entity in a civil suit and receive monetary compensation if they are successful. as is commonly known, tort law divides into three areas of liability: negligence, strict liability and intentional torts. betsy j. grey, neuroscience and emotional harm in tort law: rethinking the american approach to free-standing emotional distress claims, in 13 law and neuroscience, current legal issues 203 (michael freeman ed., oxford u. 2011); betsy j. grey, neuroscience, emotional harm, and emotional distress tort claims, 7 am. j. bioethics 65 (2007); jennifer macchiaroli eggan & eric j. laury, toward a neuroscience model of tort law: how functional neuroimaging will transform tort doctrine, 13 colum. sci. & tech. l. rev. 235 (2012); adam j. kolber, will there be a neurolaw revolution, 89 ind. l.j. 807 (2014). 2 see dan b. dobbs, the law of torts 12-20 (w. academic pub. 2000). 3 see richard a. posner, a theory of negligence, 1 j. legal stud. 29, 32 (1972). 4 mark a. geistfeld, essentials of tort law 68 (aspen 2008) (“[e]fficiency analysis assumes that the objective of tort liability is to minimize the social costs of accidents [which] increases social wealth and . . . welfare”). 5 dobbs, supra note 2, at 15. 6 yale philosophy professor jules l. coleman is a leading proponent of the corrective justice theory of tort law. see e.g., jules l. coleman, tort law and the demands of corrective justice, 67 ind. l.j. 349 (1992); jules l. coleman, the mixed conception of corrective justice, 77 iowa l. rev. 427 (1992); jules l. coleman, justice and reciprocity in tort theory, 14 u. w. ont. l. rev. 105 (1975). http://dx.doi.org/10.1093/acprof:oso/9780199599844.003.0012 http://dx.doi.org/10.1080/15265160701518813 2015 implications of neuroscience advances in tort law 673 these reflect different ways that we judge behavior and our basic theoretical justifications are adjusted depending on the regime under which we are operating. but all are premised on the ability to make a choice with regard to how to behave. tort law determines when to make people accountable for those choices. if neuroscience redefines what we mean by “choice” – if it is much more determined by neural activity in our brains than previously appreciated – we will need to examine how that affects the operation of tort law and its theoretical underpinnings. i turn to examine this question in the context of non-accidental and accidental behavior, the two areas most affected by the determination of “choice.” i. intentional acts only one theory of liability in tort law examines the mental state of the actor – when we judge non-accidental or intentional behavior.7 intentional torts are the closest theory of liability to criminal law and although the two systems have different goals, the law evaluates the state of mind of the actor in a similar fashion. typically, we ask the factfinder to determine the state of mind by using circumstantial evidence – both background information of the actor as well as direct evidence of behavior at the time of the incident. we judge this state of mind differently from criminal law in the sense that we are not looking for mens rea (“guilty mind”).8 in tort law, the defendant does not need to understand that his or her actions were wrong. instead, to determine intent, we look for purpose and knowledge.9 battery, for example, involves purposefully and knowingly – intentionally – acting to make an unconsented to touching 7 see geistfeld, supra note 4, at 114 (“all intentional torts share the common element of intent. . . .”). 8 see dobbs, supra note 2, at 49-50 (“a defendant whose conduct is intentional is not necessarily a defendant who has a bad motive or who is conscious that he is committing a legal wrong”). 9 restatement (third) of torts: phys. and emot. harm § 1 (2010). 674 indiana health law review vol. 12:2 or offensive contact.10 the plaintiff must show that the defendant has the requisite intent – the desire to cause the offensive contact or the understanding that the consequence is substantially certain to occur. we are concerned with the specific aim to carry out an act. this is a subjective test.11 the defendant must have the capacity to form the intent, but mental limitations are not taken into account except at the most extreme levels, constituting legal incapacity.12 similar concerns come into play with regard to the privilege of consent – we examine whether the plaintiff consented to the harmful act and whether the plaintiff had the capacity to consent.13 advances in neuroscience technology may help us to evaluate these states of mind. most relevant here is the study of brain processes that are involved in moral reasoning and judgment. philosophy and legal scholars have been engaged in a heated debate about the application of advances in neuroscience to determining states of mind and responsibility. this stems from a longstanding debate – argument about phrenology goes back centuries – and the debate reflects our continuous efforts to reconcile biology with philosophy. it boils down to asking how much choice we make when we act. most of the debate examines the impact of neuroscience in the courtroom in the context of criminal law, both for guilt and for sentencing. stephen morse has led the argument resisting the notion that behavior is completely determinative, which would be a movement away from the “folk psychology” explanation of human behavior.14 under the folk psychology view, 10 id. at § 5. 11 see dobbs, supra note 2, at 49 (as a state of mind, intent is necessarily subjective). 12 see geistfeld, supra note 4, at 118 (liability can be imposed on persons with mental conditions who had a delusional reason to commit tort). 13 see dobbs, supra note 2, at 224 (individuals who may not be able to give effective consent include minors, persons who are intoxicated or insane). 14 see stephen j. morse, determinism and the death of folk psychology: two challenges to responsibility from neuroscience, 9 2015 implications of neuroscience advances in tort law 675 although biology and sociological factors can play a causal role, mental states are fundamental to a full causal explanation of human action. behavior is explained “in terms of desires, beliefs and intentions”15 and virtually everything is a product of mental causation. only people, not the machinery of a brain, can intend to do wrong under this view. michael gazzaniga similarly argues that moral responsibility is a normative and legal concept that is distinguishable from physical measurements in the brain.16 joshua greene and others support a more determinative view of human behavior, using advances in neuroscience to suggest that the choice or decision to act in a certain way is much more complicated than the law originally understood.17 the argument on neural determinism became sharply focused with the work of benjamin libet in the 1980s.18 libet measured brain activity during voluntary hand minn. j. l. sci. & tech. 1 (2008). morse rejects “hard determinism” (a position which holds determinism is true and therefore necessarily no one can rightly be said to be responsible for their actions), but rather takes the “compatibilist” position, which holds that determinism is not inconsistent but compatible with common notions of agency and responsibility. id. at 15-19. 15 id. at 2-3. 16 see michael s. gazzaniga, the ethical brain 101 (2005); michael s. gazzaniga & megan s. steven, free will in the twenty-first century, a discussion of neuroscience and the law, in neuroscience and the law, brain mind and the scales of justice 51, 66 (brent garland ed., dana press 2004); benedict carey, profiles in science: michael s. gazzaniga, decoding the brain's cacophony, n.y. times, nov. 1, 2011 at d1, available at http://www.nytimes.com/ 2011/11/01/science/telling-the-story-of-the-brains-cacophony-ofcompeting-voices.html?pagewanted=all&_r=0 (gazzaniga views attempts at defining judgment and free will in terms of biological processes as a “fool’s game”). 17 see joshua greene & jonathan cohen, for the law, neuroscience changes nothing and everything, 359 phil. transactions royal soc’y biological sci. 1775 (2004). greene and cohen deem free will “an illusion generated by our cognitive architecture.” id. at 1784. the authors embrace “hard determinism” and, in light of this, suggest retributivist notions of criminal responsibility are misguided and ought give way to consequentialists ones. id. 18 see benjamin libet, mind time: the temporal factor in in consciousness (harv. u. press 2004). http://dx.doi.org/10.1098/rstb.2004.1546 676 indiana health law review vol. 12:2 movements. he found that between 500 and 1000 milliseconds before we actually move our hand there is a wave of brain activity.19 he called this period the readiness potential.20 libet set out to determine the time between that 500 and 1000 milliseconds when we make the conscious decision to move our hand. he found that the time between the readiness potential and the moment of conscious decision making was about 300 milliseconds.21 if the readiness potential of the brain is initiated before we are aware of making the decision to move our hand, it would appear that our brains know our decisions before we ever become conscious of them. studies like libet’s and others that it has spawned show promise in using functional magnetic resonance imaging (“fmri”) technology to indicate the intention to perform a task before the choice to act was finalized by the actor. this may help us understand and perhaps one day document the brain processes involved in choosing one course of conduct over another, which is precisely the issue that intentional torts address. although that day is a long way off, studies of brain processes associated with decision making based on averages potentially could be used to help a jury determine whether an individual has a brain impairment that would interfere with the ability to form the requisite intent or consent even if it does not rise to the level of total incapacity. even more intriguing is the possibility that neuroimaging evidence could be used to show the defendant’s state of mind at a particular level of development. with this evidence, defendants in a civil case potentially could argue that they never had the purpose or knowledge to commit the act in question. in roper v. simmons,22 the supreme court accepted that at least on average persons under the age of eighteen are unable to appreciate the nature of their crimes and take moral 19 benjamin libet et al., time of conscious intention to act in relation to onset of cerebral activity, 106 brain 623 (1983). 20 id. 21 id. at 636. 22 543 u.s. 551 (2005). http://dx.doi.org/10.1093/brain/106.3.623 2015 implications of neuroscience advances in tort law 677 responsibility for their actions, and found that those individuals cannot constitutionally be subjected to the death penalty.23 this holding was partially based on fmri evidence suggesting that adolescents do not have fully developed brains, in particular with regard to the frontal cortex – the area associated with impulse control.24 the same evidence demonstrated that adolescents rely more heavily than adults on the amygdala – the emotional center of the brain – for decision making in certain areas.25 perhaps based on similar evidence, a comparable paradigm shift will occur with regard to intentional torts, even though there is no constitutional overlay. a major obstacle is that the neuroscience evidence must be relevant to the mental processes involved at the time the act was undertaken as opposed to the time the data were collected. this was precisely the problem presented in the semrau case in tennessee.26 there, the defendant was trying to show lack of intent to defraud the medicare system at the time he submitted the paperwork, years before the trial. he wanted to use fmri test results as lie detector/brain fingerprinting evidence to demonstrate his knowledge and intent at the time of the act.27 this was deemed inadmissible.28 the ability of neuroscience to look at brain activity retroactively may always be limited.29 and, even if we had 23 id. at 569. 24 numerous parties filed amicus briefs proffering arguments based on neuroimaging on behalf of respondent, including the american psychological association, the american psychiatric association, and the american medical association. see e.g. brief of the american medical association et al. as amici curiae in support of respondent at 18, roper v. simmons, 543 u.s. 551 (2005) (no. 03-633) 2004 wl 1633549. 25 id. at 11. see richard a. friedman, why teenagers act crazy, sunday review, n.y. times, june 29, 2014, at sr 1 (discussing neurological underpinnings of the greater capacity of the adolescent brain for negative emotion but lesser capacity for rationality). 26 united states v. semrau, 693 f.3d 510 (6th cir. 2012). 27 id. at 515. 28 id. at 516. 29 see, e.g., teneille brown & emily murphy, through a scanner darkly: functional neuroimaging as evidence of a criminal 678 indiana health law review vol. 12:2 some insight into prior brain activity, brains change over time. so if a person were capable of forming intent at one point in time, that showing does not mean that the same capability exists at another point in time.30 further, brain studies are averages, and an individual may vary from the average scan but still be well within some “normal” range.31 improvements in brain fingerprinting technology and brain wave tests may potentially help determine the knowledge of the defendant at the time of the tort, but we are far from this point. although it is unlikely that functional imaging will replace the conventional types of external, circumstantial evidence in determining whether the requisite intentional state has been met, it is entirely plausible that it may at least supplement this evidence. further, even if individualized proof is not possible, or admissible, it may still force us to reexamine the broader implications of tort law in this area based on averages. ii. negligent acts and the reasonable person turning to accidental behavior, the largest area of focus in torts, we judge what we call negligence based on objective defendant’s past mental states, 62 stan. l. rev. 1119, 1167 (2010); owen d. jones et al., brain imaging for legal thinkers: a guide for the perplexed, 2009 stan. tech. l. rev. 5 (2009). aside from establishing the plaintiff’s baseline, other major stumbling blocks with regard to practical applications of neuroimaging persist. extrapolating information gleaned in generalized studies to a specific instance (individuation) will likely remain a difficulty. brown & murphy, supra, at 1149-50. another practical problem is dealing with the different paces at which science will document different disorders. if we can offer neuroscientific support for some claims but not for others, should we disallow the claim for the scientific laggards? 30 as there is no way to recreate an individual’s exact emotional and cognitive state at a given time, it is difficult to draw conclusions about past mental states from images taken in the present. see brown & murphy, supra note 29, at 1167. 31 id. at 1182-83. an “average” brain is an inadequate point of reference for drawing conclusions about a given individual brain. what would be needed is an average brain from a population who share all the relevant characteristics with the individual being studied; perhaps, characteristics such as race, gender, and intelligence, among others. id. 2015 implications of neuroscience advances in tort law 679 and external behavior, in contrast to the subjective state of mind involved in intentional torts. we judge that behavior based on what a reasonable person would do under similar circumstances and call that reasonable or due care.32 the reasonable person’s conduct varies according to the circumstances; it is a situational view. we assume that the reasonable person will take into account certain criteria when deciding how to act, such as the seriousness and likelihood of the risk involved and the burden of taking remedial measures.33 the standards applied to the reasonable person, according to justice holmes, are “standards of general application. the law takes no account of the infinite varieties of temperament, intellect, and education which make the internal character of a given act so different in different men.”34 there are various explanations of why we settled on this objective standard, but the most significant ones are that it offers the ease of application, an accessible translation of community expectations, and the avoidance of arbitrary interpretation.35 if we used a subjective standard instead, and tried to take into account everyone’s individual characteristics and capabilities, then we would be left with no rule at all, since the idea of exercising judgment would vary infinitely among individuals. as a result, tort law takes very few individual characteristics into account – not even mental capacity or old age – when trying to judge accidental behavior.36 a notable exception to this general 32 see dobbs, supra note 2, at § 127. (“the duty owed by all people generally . . . is the duty to exercise the care that would be exercised by a reasonable and prudent person under the same or similar circumstances to avoid or minimize risks of harm to others.”) (footnote omitted) (citations omitted). 33 posner, supra note 3, at 32. 34 oliver wendall holmes, the common law 108 (1881). 35 see dobbs, supra note 2, at 286 (“one justification for objective standards in law generally is that they are essential if the judicial process is to remain accessible and accountable. lawyers and litigants cannot evaluate judges or the legal process itself if judges could decide cases by what they felt in their heart or on the basis of messages from the deity without reference to any standards. . . .”). 36 id. at 284-85. 680 indiana health law review vol. 12:2 rule addresses physical characteristics that we can objectify easily, such as blindness and deafness.37 although physical disabilities may offer an exception to the objective standard, mental disabilities have never been treated the same way.38 this is perhaps in fear of determining who is “normal” or not; out of fairness to the plaintiff, who may not be able to refute defendant’s claim of mental disabilities; or perhaps because once those with mental disabilities are permitted to live in the world, they should be held to conform to reasonable behavior – even without the capacity to do so – or put pressure on their caretakers to increase their supervision of the individual party.39 these same reasons may also account for the way we treat old age, which we generally do not take into account to determine the reasonable person standard. neuroscience advances have begun to give us the ability to objectify mental characteristics, however. if that occurs, these advances will challenge the difference in treatment in negligence for physical and mental characteristics and the reasons for bifurcating treatment of physical and mental capacity may no longer be supportable. we may treat a mental disability like a physical disability and a party’s individual mental capabilities could be taken into account by transforming the test of reasonableness to one that compared the defendant’s actions to a reasonable person with this mental condition. this potentially would create a big inroad into the objective reasonable person standard, or at the very least, it would challenge us to determine whether there are other public policy reasons that drive the distinction between treatment of mental and physical characteristics. we have begun to recognize that physical and mental disabilities may be closely related, such as dementia in old 37 id. at 281-82. 38 restatement (third) of torts: phys. & emot. harm § 11(c)(2010) ([a]n actor’s mental or emotional disability is not considered in determining whether conduct is negligent”). 39 dobbs, supra note 2, at 284-85. 2015 implications of neuroscience advances in tort law 681 age and post-traumatic stress disorder (“ptsd”).40 with this insight, we will need to reexamine how we should treat individuals who are affected in this way – as physically disabled, and thus potentially held to an individual capacity, subjective standard, or as mentally disabled, in which case we would not take it into account in judging the reasonableness of behavior. other policy reasons may be driving the distinction, however. the restatement (third) of torts acknowledges that “many mental disabilities have organic causes” but does not advocate treating mental and physical disabilities the same.41 instead, it points to policy reasons for maintaining the distinction similar to those noted above: the problems of administrability for both less severe and more severe mental disorders; problems with causation determinations; as well as questioning whether the person should be allowed to engage in the normal range of activities within society.42 at the same time, scholars, including myself, have begun to call for an abandonment of the bifurcated rule in tort doctrine as neuroscience closes the gap between the two.43 a very interesting common law exception to the general rule of applying objective criteria to judge negligence is 40 see e.g. li wang et al., performance-based physical function and future dementia in older people, 166(10) archives internal med. 1115 (2006) (finding lower performance on physical tests correlated with greater risk of dementia); lisa shin et al., regional cerebral blood flow in the amygdala and medial prefrontal cortex during traumatic imagery in male and female vietnam veterans with ptsd, 61 archives gen. psychiatry 168 (2004) (documenting physiological changes to brain after experiencing trauma). 41 restatement (third) of torts: phys. & emot. harm § 11 cmt. e (2010). 42 id. 43 see grey, neuroscience and emotional harm in tort law: rethinking the american approach to free-standing emotional distress claims, supra note 1, at 203; see also adam j. kolber, the experiential future of the law, 60 emory l.j. 585, 622 (2011) (“from a theoretical perspective, there are no good grounds for these [additional tests regarding emotional harm claims, i.e., “zone of danger” or “physical impact,” etc.] unless they are understood as inaccurate proxies for the measurement of the intensity of a plaintiff's emotional distress. in the experiential future, such proxies should become less and less important). http://dx.doi.org/10.1001/archinte.166.10.1115 http://dx.doi.org/10.1001/archpsyc.61.2.168 682 indiana health law review vol. 12:2 children. we try to judge the behavior of a child against the standard of an ordinary child of like age, experience and intelligence.44 this is more subjective than the general reasonable person standard; we do take individual capacity into account. it is provocative to explore why we do this – it may be because we have a social view of what children ought to do, what ought to be childhood activities, and so we do not hold children responsible for the consequences of their behavior so long as they exercise ordinary care of a like child. perhaps we assume that others in the community will take care to avoid consequences of children’s activities, like the driver avoiding the child who runs into the road to chase his ball. or perhaps we want to give children eighteen years to develop at their own pace, but after that, they will be held to an objective, community standard. and yet, as noted above, we do not make the same accommodations with regard to age and infirmity when judging behavior. we may think that the pace at which people move from adulthood to old age is less uniform than the pace at which people move from childhood to adulthood. neuroscience advances may confirm or challenge these assumptions. at bottom, we assume that children are less able than adults to exercise reasonable care. as noted previously, the supreme court is willing to acknowledge differences in child development in criminal law and sentencing. neuroscience evidence may make the objective developmental cognitive stage of children more accessible as well as the subjective developmental cognitive stage of the child in question. this will push us to reexamine the standards for children when judging accidental behavior in civil cases. what if neuroscience could tell us that an individual who is eighteen actually has the brain development of a fifteen-year-old? or the fourteen-year-old has the brain development of an eighteen-year-old? these findings would challenge our bright lines of majority and 44 restatement (third) of torts: phys. & emot. harm § 10 cmt. a (“a child’s conduct is negligent if it does not conform to that of a reasonable careful person of the same age, intelligence, and experiences. . . .”) 2015 implications of neuroscience advances in tort law 683 minority, and would force us to adjust our rules to apply developmental tests to both.45 skill is another interesting exception to the objective rule. generally, we hold persons of higher skill to the level of their capacity in determining breach of duty.46 we use external measures to show this. the archetype is doctors: brain surgeons are held to a higher standard of skill when they operate.47 if we could measure the individual capacity for decision making through neuroscience advances, we may as a normative matter expect “better” or more careful decisions from individuals with more developed decisionmaking processes. finally, one potential of neuroscience advances is, instead of individualizing, we can make “community standards” more objective, without needing to rely on the subjective view of a jury of six, eight, or twelve people. we could possibly determine general normative standards of reasonable care. neuroscientists have been studying how people make choices and how brain processes respond to different problem sets involving moral, emotional and utilitarian problems.48 neuroscience is beginning to identify the parts of the brain involved in moral decision making, and finding that emotions play some role.49 some 45 related issues will likely arise in the context of concussive injuries and youth sports. although defendants (potentially sports organizations, schools, or equipment manufacturers) are likely to charge plaintiffs with comparative fault, it may be difficult to determine at what point brain development has been impaired and whether that impact has affected judgment. neuroscience advances may help us determine consent and assumption of risk in those settings. 46 restatement (third) of torts: phys. and emot. harm § 12 (2010) (“if an actor has skills or knowledge that exceed those possessed by most others, these skills or knowledge are circumstances to be taken into account in determining whether the actor has behaved as a reasonably careful person.”). 47 see dobbs, supra note 2, at 290. 48 see joshua d. greene, the cognitive neuroscience of moral judgment, in michael s. gazzaniga, the cognitive neurosciences 987, 990-91 (mit press 4th ed. 2009). greene observed fmri images while participants responded to questions in relation to moral dilemmas such as the “trolley problem.” id. 49 the amygdala is typically implicated in these findings. see id. at 990-94 (offering an overview of the relevant studies). 684 indiana health law review vol. 12:2 scholars criticize this research as suffering from methodological flaws,50 casting doubt on any conclusions drawn from the studies. nevertheless, it is believed these issues can be resolved51 and even critics of the studies are optimistic as to the efficacy of this avenue of research,52 which will presumably lead to better information on the brain processes of the reasonable person. right now, we do not couch our studies in terms of the “reasonable” person, but at some point these averaged results could offer some useful generalized information. two negligence-based torts provide examples of the impact that neuroscience advances may have on specific torts: the tort involving infliction of emotional harm and the duty of a psychotherapist to warn a third party of the dangerous tendencies of his patient. iii. substantiating emotional harm the general rule at common law is that a negligent actor is not responsible for conduct that causes only mental distress.53 slowly, certain exceptions developed to this 50 see g. kahane & n. shackel, methodological issues in the neuroscience of moral judgment, 25 mind & language 561, 565-72 (2010) (criticizing joshua greene’s work [supra note 48] for imprecise question framing in relation to the moral dilemmas, the lack of inquiry into the moral reasoning which lead to the participants responses, and for equating a response to a given moral dilemma to a belief in a certain moral theory generally); j.f. christensen & a. gomila, moral dilemmas in cognitive neuroscience of moral decision-making: a principled review, 36 neuroscience and biobehavioral rev. 1249 (2012) (noting various issues with the formation of the dilemmas and the framing of the corresponding questions in joshua greene’s [supra note 48] and others’ similar studies). 51 see e.g. christensen, supra note 50, at 1262 (suggesting the methodological pitfalls of these studies can be remedied through greater care in identifying and controlling independent variables). 52 see id. (concluding “moral dilemmas in neuroethics has much to contribute to our understanding of human moral psychology. . . . and “are a highly valuable tool for assessing human moral cognition”). 53 restatement (third) of torts: phys. & emot. harm § 47 cmt b (2012) (citing exceptions to general rule that an actor is not liable for negligent conduct that causes only emotional harm); robert j. rhee, a principled solution for negligent infliction of emotional distress http://dx.doi.org/10.1111/j.1468-0017.2010.01401.x http://dx.doi.org/10.1016/j.neubiorev.2012.02.008 2015 implications of neuroscience advances in tort law 685 general rule, but it has never been given equal status with other tort claims. at bottom, this difference in treatment reflects the fundamental belief that the free standing claims of “emotional harm” are “less deserving” than those for physical consequences. courts moved slowly and cautiously for several reasons. validity has always been a primary concern, with the fear that the claim may be untrustworthy.54 in addition, courts expressed concern that the claim was trivial, or might give rise to the proverbial floodgates to claims for money damages, or might provide an easy way to make false claims.55 thus, rather than rely solely on foreseeability of harm as a prerequisite to recover for emotional harm accidentally inflicted, courts developed a series of limiting tests, such as the “physical impact” test, evidence of some physical manifestation of the shock or fright that has occurred, or a showing that the plaintiff was in the “zone of physical danger” by virtue of the defendant’s negligence.56 from an instrumentalist viewpoint, the limitations reflect the concern of opening the floodgates of litigation as well as the related concern of potentially crushing liability. the courts recognized the need to prioritize claims in a pool of limited funds and decided to prioritize physical and property damage claims over emotional harm claims.57 and claims, 36 ariz. st. l. j. 805, 813 (2004) (“ common law did not recognize claims for mental injuries from negligent acts”). 54 john l. diamond et al., understanding torts 146 (lexisnexis 3d ed. 2007) (“because of general skepticism of emotional distress as an injury, and fear that permitting emotional distress recovery will lead to fraudulent claims, much judicial effort has gone toward constraining this cause of action.”); see restatement (third) of torts: phys. & emot. harm § 47 cmt. l (2012) (“the seriousness threshold assists in ensuring that claims are genuine. . . .”). 55 see e.g., john j. kircher, the four faces of tort law: liability for emotional harm, 90 marq. l. rev. 789, 808 (2007). 56 see id. at 810-15 (discussing the history of the “physical impact,” “physical manifestation,” and “zone of danger” requirements and identifying jurisdictions that make use of these gatekeeping tests). 57 see robert l. rabin, emotional distress in tort law: themes of constraint, 44 wake forest l. rev. 1197, 1200 (2009). professor rabin, in reference to asbestos litigation, explains: 686 indiana health law review vol. 12:2 they are also concerned that liability for emotional harms would be disproportionate to the tort involved, since a single tort could cause a large number of people to suffer some degree of distress.58 these themes reflect a commitment to curtail widespread litigation rights. underlying much of this is the assumption that physicians who treat disorders of the body can point to empirical evidence whereas those who treat disorders of the mind cannot. this is true. we cannot point to the underlying biological bases of most psychiatric disorders. we do not understand them as well as we understand disorders of the heart or the stomach. but this is beginning to change. the advances in research with regard to depression provide a good example. we are beginning to understand the outlines of the neural circuit that is involved in depression. dr. helen mayberg is using brain scanning to identify this circuit. her research suggests that two are particularly important: area 25 (the subcallosal cingulate region), which mediates unconscious and motor responses to emotional distress; and the right anterior insula, a region where we experience self-awareness and awareness of others.59 dr. mayberg gave people with diagnosed depression one of two types of treatment: cognitive behavioral therapy, which is a form of psychotherapy; or an antidepressant not too far into the tidal wave of bankruptcies, it became apparent that prioritizing claims was an absolute necessity if depletion of the limited pool of available funds was to reflect fairness considerations, namely, recognizing the compelling claims for ‘most deserving’ on the part of those suffering the most serious physical consequences. id. 58 id. at 1203 (discussing a “fairness concern about disproportionality between responsibility for accidentally imposed harm and ‘stacked claims’—that is, multiple claims by distressed family members in virtually every case of negligently caused serious injury or death of a primary victim”). 59 helen s. mayberg et al., toward a neuroimaging treatment selection biomarker for major depressive disorder, 70(8) jama psychiatry 821 (2013). http://dx.doi.org/10.1001/jamapsychiatry.2013.143 2015 implications of neuroscience advances in tort law 687 medication. she found that people with below-average baseline activity in the right anterior insula responded well to the psychotherapy but did not respond well to the medication.60 people with above average activity in the right anterior insula responded to the medication but not to the psychotherapy.61 she thus found that she could predict a depressed person’s response to specific treatments by their baseline activity in the right anterior insula.62 these results suggest that we can identify measurable specific markers of a mental disorder. and we can use those biomarkers to predict the outcome of two different treatments, psychotherapy and medication. it also suggests that the effects of psychotherapy are biological and detectable and can be measured empirically. that is a very significant advance in the way we look at the biology of mental disorders. another interesting example involves the research on the neural circuit that is involved in ptsd, which is a highly studied area. on a most basic level, it seems that two key structures are involved: the amygdala and prefrontal cortex.63 the amygdala is considered the emotional center of the brain, which stimulates the “arousal system” when trauma and stress are experienced.64 the pre-frontal cortex is considered the controlling mechanism to keep our emotions in check.65 the prefrontal cortex regulates our experience of emotion, and it naturally compensates for aversive events.66 when allowed to 60 id. at 826-27. 61 id. 62 id. at 827. 63 michael koenigs & jordan grafman, post-traumatic stress disorder: the role of medial prefrontal cortex and amygdala, 15 neuroscientist 540, 547 (2009). 64 j.l mcgaugh, memory consolidation and the amygdala: a systems perspective, 25 trends in neuroscience 465 (2002). the basolateral complex of the amygdala is activated by emotional arousal, helping to consolidate emotionally charged experiences into the longterm memory. id. 65 arthur p. shimamura, the role of the prefrontal cortex in dynamic filtering, 28 psychobiology 207, 213 (2000). 66 benno roozendaal et al., stress, memory and the amygdala, 10 nature rev. neuroscience 423, 423 (2009). http://dx.doi.org/10.1177/1073858409333072 http://dx.doi.org/10.1016/s0166-2236(02)02211-7 http://dx.doi.org/10.3758/bf03331979 http://dx.doi.org/10.1038/nrn2651 688 indiana health law review vol. 12:2 function properly the prefrontal cortex facilitates the formation of new connections that overrides the traumatic memory (a process called extinction).67 scientists now believe that anxiety disorders, including ptsd, result when the circuitry between the amygdala and the pre-frontal cortex is disrupted. in other words, acute stress can impair the pre-frontal cortex function. our natural response to dealing with stress and trauma does not occur: the amygdala is not inhibited and continues to be hyperactive. extinction does not occur and we exhibit anxiety symptoms.68 this malfunction or dysregulation leads to alterations in the interpretative processes – more precisely, a threatoriented bias in anxious individuals. this means that individuals with anxiety disorders react with distress and hyperarousal to stimuli that objectively would be interpreted as neutral or only mildly adversive. these individuals attempt to avoid the anxiety-provoking object or situation. eventually, this dysregulation is reflected on a behavioral level when outward symptoms start to present themselves. we view these as clinically significant symptoms. these resulting physiological changes in the brain following a trauma – and the advances in science that allow us to study them in greater and greater depth – provide a basis for the theory that it may be possible to quantify the physical changes in the brain that underlie what we think of as emotional harm. several studies support this theory linking amygdalar dysfunction and anxiety disorders. a 2004 study by lisa shin compared the positron emission tomography (“pet”) scans of seventeen vietnam veterans with diagnosed ptsd to pet scans of nineteen vietnam veterans without ptsd.69 67 id. at 427-31. 68 id. 69 lisa shin et al., supra note 40, at 168. the researchers used script-driven imagery to conduct the study. all of the male participants had served in combat and all of the female participants had served as nurses in vietnam. none of the veterans had a history of head injury, neurological disorders, or other major conditions. id. at 169. 2015 implications of neuroscience advances in tort law 689 results of the study indicated hyperresponsivity of the amygdala and hyporesponsivity of the medial prefrontal regions of those diagnosed with ptsd.70 the more hyperand hypo-active these regions were, respectively, the more severe the symptoms.71 while such a relationship between the amygdala and medial prefrontal regions in clinically diagnosed ptsd patients had been suspected, no previous studies in the literature had documented data in support of such a relationship. a meta-analysis conducted by etkin and wager compared fmri and pet scans of individuals with one of three anxiety disorders, including ptsd, with scans of healthy individuals who had undergone fear conditioning.72 the results indicated that patients with the anxiety disorders showed consistently greater activity in the amygdala and insula.73 the most exaggerated dysregulation was in the neural circuitry of ptsd. these are just two studies, but they indicate that scientists may now begin to document and observe the physiological changes that occur in the brain after experiencing trauma. they suggest that one day we may be able to use biological markers to determine whether and when individuals suffer from emotional harm. suffering distress over time may result in physical symptoms or differences in the brain. in other words, neuroscience may lead us to the principle that our mind and our brain are inseparable, at least with regard to what we think of as emotional harm. at the least, these advances suggest that we should not limit the claim because of failure of proof. they should allow us to move away from the more artificial and arbitrary tests in this area and to redraw the sharp distinction between physical and emotional harms drawn in 70 id. at 174. 71 id. 72 amit etkin & tor d. wager, functional neuroimaging of anxiety: a meta-analysis of emotional processing in ptsd, social anxiety disorder, and specific phobia, 164 am. j. psychiatry 1476 (2007) (the researchers analyzed social anxiety disorder, ptsd, and specific phobia). 73 id. at 1476. http://dx.doi.org/10.1176/appi.ajp.2007.07030504 690 indiana health law review vol. 12:2 the law, or at least clarify our reasons for allowing or disallowing compensation for this harm. iv. the psychotherapist’s duty to warn a second example of how advances in neuroscience may challenge a negligence-based duty involves the duty of psychotherapists. a lot has changed since justice tobriner of the california supreme court wrote the following in 1976 in the seminal case, tarasoff v. regents of the university of california:74 when a therapist determines, or pursuant to the standards of his profession should determine, that his patient presents a serious danger of violence to another, he incurs an obligation to use reasonable care to protect the intended victim against such danger.75 the tarasoff case thus requires psychotherapists sometimes to breach patient confidentiality and move outside their role as care-givers of individual patients, to function as an agent for social protection. almost every state has accepted and some have extended tarasoff, although a few jurisdictions have rejected it.76 some states have adopted it by case law and others by statute.77 new york state enacted legislation in 2013 that moves that state’s law from a permissive to a mandatory duty for mental health professionals to report when they believe that 74 551 p.2d 334 (cal. 1976). 75 id. at 340. 76 marc a. franklin et al., tort law and alternatives: cases and materials 160 n.6 (foundation press 9th ed. 2011) (“most states have accepted and some have extended tarasoff”); peter f. lake, revisiting tarasoff, 58 alb. l. rev. 97, 98 (1994). 77 see e.g., idaho code ann. § 6-1903 (2014); mich. comp. laws § 330.1946 (2015); mont. code ann. § 27-1-1102 (2014); bardoni v. kim, 390 n.w.2d 218, 221-22 (mich. ct. app. 1986); peck v. counseling serv., 499 a.2d 422, 425 (vt. 1985); mcintosh v. milano, 403 a.2d 500, 506-07 (n.j. super. ct. law div. 1979); bradley v. ray, 904 s.w.2d 302, 306-11 (mo. ct. app. 1995). 2015 implications of neuroscience advances in tort law 691 patients may pose a danger to themselves and others, but protects therapists from both civil and criminal liability for failure to report if they act in “good faith.”78 the key question under tarasoff is the psychotherapist’s ability to predict the danger of committing violence to another. given the recent history of mass shootings in our country, we are sharply focused on the ability to predict violence before it happens. in the nearly four decades since tarasoff, the field of violence risk assessment has grown tremendously.79 these developments in risk assessment research – in particular with regard to neuroimaging – have tremendous implications for the professional standards of conduct for psychotherapists and the imposition of the duty to warn. one example of research in this area is that of professor kent kiehl, who has been performing brain imaging scans on incarcerated individuals in the new mexico state prison system.80 in the first three years of his testing, more than 1100 inmates volunteered to participate in the fmri studies, creating a very large database.81 his findings are fascinating: they show a “robust and persistent pattern of abnormal brain function” in the psychopathic population, “namely decreased neural activity in the paralimbic regions 78 n.y. mental hygiene law § 9.46 (mckinney 2015). this provision was written in the context of gun control legislation. 2013 n.y. sess. laws ch. 1 (s. 2230) (mckinney). 79 see jennifer l. skeem & john monahan, current directions in violence risk assessment, 20 current directions psychol. sci. 38, 38 (2011) (noting the increasing development of u.s. law governing the process of violence risk assessment, and discussing the variety of instruments that have recently been published for this task); john monahan, tarasoff at thirty: how developments in science and policy shape the common law, 75 u. cin. l. rev. 497, 497-98 (2006) (describing “vast and vibrant” burgeoning field of violence risk assessment). 80 kent a. kiehl & morris b. hoffman, the criminal psychopath: history, neuroscience, treatment, and economics, 51 jurimetrics j. 355, 384-85 (2011). roughly 20% of the prison population is psychopathic. id. at 381. 81 id. at 385. http://dx.doi.org/10.1177/0963721410397271 692 indiana health law review vol. 12:2 of the brain.”82 his research suggests that the story of the psychopath is largely in the limbic and paralimbic systems rather than the prefrontal cortex.83 kiehl suggests that this finding dovetails with the central paradox of the psychopath, who is completely rational but morally insane.84 if the key to psychopathy lies in these larger regions, then we can understand how the psychopath is able to recruit his higher functions to navigate the world. kiehl also argues that these results suggest that we may be able to diagnose psychopathy through a neurological condition,85 as well as increase our understanding of these traits in ways that might also improve treatment. advances such as these might change the science of violent risk assessment and thus have a profound effect on the duty of the psychotherapist or others86 to breach confidentiality and warn a third party, whether it be the police or an individual. the implications of this are enormous, as we struggle in society to protect individual rights of privacy and treatment with society’s concern with protection against shootings such as those that have occurred in sandy hook, aurora, tucson and the navy shipyard. 82 id. 83 id. at 385-86. 84 id. at 390. kiehl explains: [psychopaths] are certainly rational in the narrow sense of being able to determine their best interest and to navigate in the world to achieve that interest. in fact, in some sense they are hyperrational. they consider only their self-interest and they are masters, at least in the short run, of manipulating the world to those interests. . . . a psychopath would no more hesitate to rob a victim of $20 than you or i would hesitate to pick up $20 dollars sitting on the sidewalk. id. at 370 (emphasis in original). 85 id. at 390. 86 access to neuroimaging that reveals dangerous psychopathy could conceivably occur in other relationships as well, such as exams for professional licenses or insurance coverage, which may engender new reporting duties. 2015 implications of neuroscience advances in tort law 693 v. conclusion neuroscience has not yet reached the point where it enables us to detect prior intent, quantify mental capacity, validate emotional harm claims or predict a tendency to commit violence. yet advances in neuroimaging are real, and it is clear that these questions are not the enigma they once were. these advances challenge our traditional tort doctrine and supporting policy reasons, forcing us to clarify our reasons for allowing or disallowing compensation in various areas. they suggest that it may no longer be sufficient to cling to old doctrines because of failures of proof. we need to rethink whether other policy reasons justify maintaining our traditional doctrines on, for example, determining intent, applying objective standards for negligence, treating emotional harm differently from physical injury, or imposing a civil duty to warn on a psychotherapist. i. intentional acts ii. negligent acts and the reasonable person iii. substantiating emotional harm iv. the psychotherapist’s duty to warn v. conclusion microsoft word 1-volume xii masthead.docx peeking behind the robes: a not-so-flattering look at medicare’s administrative law judges michael barry∗ i. introduction ................................................................... 66 ii. medicare and its appeals process .............................. 67 a. level 3 (alj) appeals–additional details ................. 70 iii. oig report .................................................................... 74 a. methodology ................................................................. 74 b. findings ....................................................................... 75 1. providers filed 85% of alj appeals .......................... 75 2. cms participation in appeals .................................... 76 3. accepting new evidence ............................................. 77 4. additional oig recommendations ............................. 78 iv. major deficiencies with administrative law judges .. 79 a. knowledge, expertise, and competency of aljs ....... 79 1. decisions based on “intent” rather than applicable law .................................................................................... 80 2. difficulty understanding medicare law.................... 82 3. judicial bias ................................................................. 84 4. deficient training ........................................................ 86 b. handling fraud ........................................................... 88 1. obama administration................................................ 90 2. federal law ................................................................. 91 3. fraud-reporting requirements for private entities involved in medicare ........................................................ 94 4. deterrent effect of fraud reporting .......................... 96 c. appeal record .............................................................. 97 1. records forwarded to the medicare appeals council............................................................................... 97 v. conclusion ................................................................... 101 * michael p. barry. b.a., brigham young university, j.d., university of missouri-columbia school of law. my experience includes service as legal counsel, chief compliance officer, and hipaa privacy officer. i have argued dozens of medicare appeals before administrative law judges. all opinions expressed in this article are mine. http://dx.doi.org/10.18060/18960 66 indiana health law review vol. 12:1 i. introduction over forty-nine million elderly and disabled americans currently receive health care coverage through medicare. it is a massive government program that accounted for 14% of the federal budget in 2013.1 in the event that medicare refuses to cover an enrollee’s request for a specific medical treatment, item, or prescription drug, that individual may appeal the decision through a multi-tiered appeals process. the third stage of a medicare appeal involves a hearing before an administrative law judge (alj). these aljs are employed by the office of medicare hearings and appeals (omha), an agency within the u.s. department of health and human services (hhs). aljs have a critical responsibility to take evidence at hearings, serve as a trier of facts, and, ultimately, render a decision on the merits of the appeal. in november 2012, the office of inspector general (oig) of hhs issued a report entitled improvements are needed at the administrative law judge level of medicare appeals.2 the oig report provides an interesting statistical analysis of alj cases, along with ten recommendations from the oig intended to improve the accuracy, efficiency, and reliability of alj decisions. but more importantly, it reveals serious deficiencies by aljs, and their staff, that need to be addressed and remediated above and beyond the oig recommendations. part ii of this article will provide a brief overview of medicare and its appeals process, with an emphasis on the third level of appeals before aljs. part iii will examine the findings and recommendations from the oig. and part iv will provide an in-depth analysis of the major deficiencies and failures of medicare’s aljs. 1 kaiser family foundation, the facts on medicare spending and financing (july 28, 2014), available at http://kff.org/medicare/factsheet/medicare-spending-and-financing-fact-sheet/, archived at http://perma.cc/9fev-5rx5. 2 office of inspector gen., dep’t of health & human servs., oei-02-10-00340, improvements are needed at the administrative law judge level of medicare appeals (2012) [hereinafter oig report]. 2015 peeking behind the robes 67 ii. medicare and its appeals process medicare is a “federally funded medical insurance program for the elderly and disabled.”3 it originally became law in 1965, when it passed as an amendment to the social security act.4 medicare is available to individuals age sixty-five or older and disabled persons entitled to social security disability benefits. individuals younger than sixtyfive who have end-stage renal disease or amyotrophic lateral sclerosis (als)5 are also entitled to participate. the medicare program is administered jointly through hhs and the centers for medicare & medicaid services (cms).6 today medicare is comprised of four parts: a, b, c, and d. part a is known as the hospital insurance (hi) program. it covers inpatient hospital care, post-acute home health care services, short-term care in skilled nursing facilities, and hospice care.7 part b, the supplementary medical insurance (smi) program, helps pay for outpatient medical care from physicians and other medical practitioners, laboratory services, some home health care, physical and occupational therapy, and durable medical equipment (dme) and supplies.8 part c, also known as medicare advantage (ma),9 allows private health insurance plans to contract with the federal government to provide medicare-covered health services under parts a and b, with 3 fischer v. u.s., 529 u.s. 667, 671 (2000). 4 social security amendments of 1965, pub. l. no. 89-97, 79 stat. 286 (1965) (codified at 42 u.s.c. § 1395 et seq. (2014)). 5 als is also known as lou gehrig’s disease. 6 prior to restructuring in 2001, cms was known as the health care financing administration (hcfa). 7 see 42 u.s.c. §§ 1395c-d (2014). 8 see 42 u.s.c. §§ 1395j-k (2014). 9 the part c program was originally known as “medicare+choice,” but the name was changed to “medicare advantage” in december 2003 with the passage of the medicare prescription drug, improvement, and modernization act. see medicare prescription drug, improvement, and modernization act of 2003, pub. l. no. 108-173, 117 stat. 2066 (dec. 8, 2003) [hereinafter mma]. 68 indiana health law review vol. 12:1 some exceptions. 10 and part d provides coverage for prescription drugs, biologicals, and vaccines. 11 part d is offered through prescription drug plans (pdps) and ma plans with drug coverage. medicare’s appeal process is designed to reverse erroneous claim denials and correct mistakes.12 it can only begin after an “initial determination” is made that denies coverage, in whole or in part, for a medicare enrollee.13 the enrollee, an appointed representative, or assignee (i.e., the practitioner or medical supplier who provided the service or item) can then appeal this decision. the appeals process includes five levels, and the appellant must exhaust each level before proceeding to the next level. the five levels are: level 1: for parts a and b, a medicare contractor will make a “redetermination.”14 here the same medicare contractor who made the initial determination will take a second look at the claim, although a different individual will review it. for parts c and d, the ma plan or the pdp will also review and take a second look at the claim.15 there is no minimum amount in controversy for a level 1 appeal. 10 see 42 u.s.c. §§ 1395w-21 et seq. (2014). the balanced budget act created part c in 1997 to encourage wider availability of managed care options in medicare through health maintenance organizations (hmos) and the participation of other types of coordinated care plans. see balanced budget act of 1997, pub. l. no. 105-33, § 4001, 111 stat. 251 (1997). 11 see 42 u.s.c. §§ 1395w-101 to -151 (2014). medicare’s part d program was established pursuant to the mma. see medicare prescription drug, improvement, and modernization act of 2003, pub. l. no. 108-173, §§ 101-11, 117 stat. 2066, 2174-76 (2003). 12 see 42 u.s.c. § 1395ff (2014); 42 c.f.r. §§ 405.900 -.1140 (2014). 13 42 c.f.r. § 405.803(a) (2014); see also 42 c.f.r. § 405.920 (2014). 14 see 42 c.f.r. §§ 405.940-.958 (2014). 15 see 42 c.f.r. §§ 422.578-.590 (2014); 42 c.f.r. §§ 423.580-.590 (2014). 2015 peeking behind the robes 69 level 2: for parts a and b, a “reconsideration”16 will be conducted by a “qualified independent contractor” (qic), a third-party reviewer that is under contract with cms.17 for parts c and d, a review will be conducted by an “independent review entity” (ire), also a thirdparty reviewer contracted by cms.18 level 2 appeals are conducted after a review of evidence in the case file.19 there is no minimum amount in controversy for a level 2 appeal. level 3: review before an alj from the hhs omha. the minimum amount in 16 see 42 c.f.r. § 405.974 (2014). 17 qics are assigned based on the geographic location where the service was rendered. cms has designated qics for the following jurisdictions: part a east jurisdiction – maximus, inc. (maximus); part a west jurisdiction – maximus; part b north jurisdiction – c2c solutions, inc. (c2c); part b south jurisdiction – c2c; and dme jurisdiction – c2c. in 2013 alone, qics processed approximately 1,392,000 reconsiderations. see cms fact sheet, original medicare (fee-for-service) appeals data – 2013, available at http://www.cms.gov/medicare/appeals-andgrievances/orgmedffsappeals/reconsiderationbyaqualifiedindepende ntcontractor.html (accessed by downloading appeals fact sheets). 18 see 42 c.f.r. §§ 422.592-.596 (2014); 42 c.f.r. §§ 423.600-.604 (2014). cms has designated maximus as the ire for part c and part d appeals. in 2013, maximus processed 142,953 reconsiderations. see cms fact sheet, part c reconsideration appeals data – 2013, available at http://www.cms.gov/medicare/appeals-andgrievances/mmcag/ire.html (accessed by downloading fact sheets: part c reconsiderations appeals data). see also cms fact sheet, part d reconsideration appeals data – 2013, available at http://www.cms.gov/medicare/appeals-andgrievances/medprescriptdrugapplgriev/reconsiderations.html (accessed by downloading fact sheets part d reconsideration appeals data). 19 the case file refers to the administrative record, which generally includes claims, medical records, and other evidence. see 42 c.f.r. § 405.1044(b) (2014). 70 indiana health law review vol. 12:1 controversy for a claim at the alj level is $150.20 level 4: review by the medicare appeals council (mac) from the hhs departmental appeals board.21 there is no minimum amount in controversy for an appeal at this level, but the mac may decline to review a case. this is the final administrative review level for medicare appeals. level 5: review by a local federal district court. the minimum amount in controversy is $1,460.22 a. level 3 (alj) appeals–additional details because this article deals primarily with medicare appeals at the alj level, additional details about this appellate level will be discussed. any party dissatisfied with the outcome of a level 2 appeal has the right to request a hearing before an alj.23 alj hearings may be conducted in three ways: (1) in-person, (2) by videoteleconference, or (3) by telephone.24 because omha’s aljs operate out of just four regional offices,25 in-person 20 see medicare appeals: adjustment to the amount in controversy threshold amounts for calendar year 2014, 78 fed. reg. 59702-01, 59703 (sept. 27, 2013). see also 42 c.f.r. § 405.1006(b) (2014). in 2014, the minimum amount in controversy was $140. 21 the mac is located in washington, d.c. 22 see medicare appeals: adjustment to the amount in controversy threshold amounts for calendar year 2014, 78 fed. reg. 59702-01, 59703 (sept. 27, 2013). see also 42 c.f.r. § 405.1006(b) (2011). in 2014, the minimum amount in controversy was $1,430. 23 see 42 c.f.r. §§ 405.1002, 422.600, 423.1970 (2014). 24 see 42 c.f.r. §§ 405.1000(b) (2007), 405.1020(b) (2011); medicare appeals; adjustment to the amount in controversy threshold amounts for calendar year 2013, 77 fed. reg. 59618-01 (sept. 28, 2012). 25 the names and locations of omha’s regional offices are: (1) midatlantic field office in arlington, virginia; (2) southern field office in miami, florida; (3) mid-west field office in cleveland, ohio; and (4) western field office in irvine, california. omha’s central office is 2015 peeking behind the robes 71 hearings are not very common and are provided only in “special or extraordinary circumstances.”26 omha currently has 65 aljs on staff. a denied claim at level 2 can only be appealed to level 3 if it meets the $150 minimum amount in controversy. however, if a single denied claim fails to meet the $150 threshold, an appellant may aggregate claims that involve “common issues of law and fact” in order to reach the required dollar minimum.27 an alj’s review of an appeal is de novo.28 an alj is subject to several types of mandatory and persuasive authority. “all laws and regulations pertaining to the medicare and medicaid programs, including . . . titles xi, xviii, and xix of the social security act and applicable implementing regulations, are binding on aljs.”29 national coverage determinations (ncds) are also “binding,”30 so an alj “may not disregard, set aside, or otherwise review an located in arlington, va. the locations of the regional offices may appear to be quite random. however, hhs selected these locations based on research that considered, among other things, the then-current and projected geographic distribution of medicare claims appeals. see changes to the medicare claims appeal procedures, 74 fed. reg. 65296, 65322 (december 9, 2009). 26 42 c.f.r. § 405.1020 (b) (2) (2014). 27 42 c.f.r. § 405.1006 (e) (2014). for appellants, “common issues of law and fact” means that “the claims sought to be aggregated are denied, or payment is reduced, for similar reasons and arise from a similar fact pattern material to the reason the clams are denied or payment is reduced.” 42 c.f.r. § 405.1006 (a) (1) (2014). 28 see 42 c.f.r. § 405.1000 (d) (2014). in a de novo hearing, the reviewing body considers the “matter anew, giving no deference to a lower court’s findings.” black’s law dictionary 738 (8th ed. 2004). cms states that in a de novo hearing, “[a]djudicators at each level of appeal make a new, independent and thorough evaluation of the claim(s) at issue, and are not bound by the findings and decision made by an adjudicator in a prior determination or decision.” ctrs. for medicare & medicaid servs., medicare claims processing manual, pub. l. no. 100-04, ch. 29, § 110 (2013) [hereinafter mcpm], available at http://www.cms.gov/regulations-andguidance/guidance/manuals/internet-only-manuals-iomsitems/cms018912.html. 29 42 c.f.r. § 405.1063(a) (2014). 30 42 c.f.r. §§ 405.1060(a)(4) (2014). 72 indiana health law review vol. 12:1 ncd.”31 but an alj may review the facts of a particular case to determine whether the ncd has been “applied correctly” to the claim.32 on the other hand, an alj is not bound by local coverage determinations (lcds)33 and cms guidance.34 an alj, however, must “give substantial deference to these policies if they are applicable to a particular case.”35 cms or one of its contractors may elect to participate in an alj hearing as either a participant or a party.36 as a participant, cms can file position papers or “provid[e] testimony to clarify factual or policy issues in a case,” but it may not call or cross-examine witnesses.37 an alj has the option to request that cms, and/or its contractors, participate in a hearing, but the alj does not have authority to mandate cms’ participation.38 if cms elects to participate as a party, it may “file position papers, provide testimony to clarify factual or policy issues, [and] call witnesses or cross-examine the witnesses of other parties.”39 all evidence considered by the alj must have been submitted previously to the qic or ire during the level 2 appeal. with the exception of verbal testimony offered 31 42 c.f.r. § 405.1060(b)(1) (2014). an ncd is “a determination by the [hhs] secretary with respect to whether or not a particular item or service is covered nationally . . . but does not include a determination of what code, if any, is assigned to a particular item or service covered . . . or a determination with respect to the amount of payment made for a particular item or service so covered.” 42 u.s.c. § 1395ff(f)(1)(b) (2014). see also 42 c.f.r. § 405.732(a) (2011). 32 42 c.f.r. §§ 405.732(b)(2), 405.860(b)(2) (2011). 33 an lcd is a decision by a contractor or carrier under medicare part a or part b whether to cover a particular service on a contractorwide basis in accordance with medicare’s “reasonable and necessary” criteria for certain diagnoses/diagnosis codes. 42 c.f.r. § 400.202 (2014). see also information about lcds and lcd challenges, cms.gov, http://www.cms.gov/medicare-coverage-database/. (“medicare contractors develop lcds when there is no ncd, or when there is a need to further define an ncd.”) 34 see 42 c.f.r. § 405.1062(a) (2014). 35 id. 36 see 42 c.f.r. §§ 405.1010(b), 405.1012(a) (2014). 37 42 c.f.r. § 405.1010(c) (2014). 38 42 c.f.r. § 405.1010(a) (2014). 39 42 c.f.r. § 405.1012(c) (2014). 2015 peeking behind the robes 73 during the hearing, 40 any “new evidence” that was not submitted during level 2 “must be accompanied by a statement explaining why the evidence was not previously submitted.”41 the alj will then consider whether “good cause” exists for submitting the evidence for the first time at the alj level.42 if the alj does not find “good cause,” then the evidence must be excluded from the hearing and the alj may not consider it when making his or her determination.43 if “good cause” exists, then the alj may consider the evidence.44 during a hearing the alj may question the parties and other witnesses.45 the parties are also allowed to question witnesses.46 any party to the hearing has the right to “present evidence and to state his or her position.”47 parties may also present written statements to the alj about the facts and the law material to the case.48 these documents must be provided to the other parties at the same time they are filed with the alj.49 following the hearing, the alj must issue a decision in 90 days. otherwise, the appellant can escalate the appeal to the mac.50 40 42 c.f.r. § 405.1018(d) (2014). 41 42 c.f.r. § 405.1018(c) (2014). 42 42 c.f.r. § 405.1028(a) (2014). the applicable medicare regulations inconveniently do not include a definition of “good cause.” however, cms fills in the gaps with its own conditions and examples of good cause for enrollee, providers, and suppliers. see mcpm, supra note 29, at §§ 240.2-.4. 43 42 c.f.r. § 405.1030(e) (2014). see also 42 c.f.r. § 405.1028(c) (2014). 44 42 c.f.r. § 405.1030(d) (2014). 45 see 42 c.f.r. § 405.1030(b) (2014). 46 see 42 c.f.r. § 405.1036(g) (2014). 47 42 c.f.r. § 405.1036(a)(1) (2014). 48 see 42 c.f.r. § 405.1036(c) (2014). 49 id. 50 see 42 c.f.r. §§ 405.1034; 405.1052; 405.1104 (2014). 74 indiana health law review vol. 12:1 iii. oig report a. methodology the oig report is largely based on a statistical analysis of alj appeals that were decided in fiscal year 2010. it is also the result of findings from oig interviews with aljs and their support staff. the oig also interviewed the chief alj, the executive director of omha, the managing alj from each omha field office, 51 and a sample of alj teams. interviews were also conducted with key staff from four of the five qics and the administrative qic, which provides support to qics. finally, the oig reviewed relevant medicare policies, procedures, omha and cms training materials, and other data. it is relevant to note that the scope of the oig’s review was less than comprehensive. the oig failed to interview any administrators of prescription drug plans (pdps) and medicare advantage (ma) plans. it also neglected to interview anyone from maximus, the ire that is heavily involved in level 2 part c and part d appeals. furthermore, the oig did not consult any providers who are regularly involved in the appeals process. 52 the oig also failed to interview any state medicaid agencies that may appeal when questions arise as to whom should pay “for services or items received by individuals covered by both medicare and medicaid.53 as a result, the oig has delivered a report that includes a good analysis of medicare’s aljs, but is nonetheless incomplete. 51 “the managing administrative law judge (malj) is responsible for the administration of the field office, and is charged with ensuring the just, timely, accurate, and professional adjudication of all medicare claims appeals.” 74 fed. reg. 65,296, 65,323 (december 9, 2009). 52 here “provider” refers generally to those who provide medical treatment or medical supplies to medicare enrollees. it therefore includes physicians, clinics, hospitals, provider groups, skilled nursing facilities (snfs), and medical suppliers, such as those who provide durable medical equipment, prosthetics, orthotics, and supplies (dmepos). 53 individuals with coverage under both medicare and medicaid are known as “dual eligibles.” 2015 peeking behind the robes 75 b. findings 1. providers filed 85% of alj appeals for its report, the oig analyzed a total of 40,682 appeals that aljs adjudicated in fiscal year 2010.54 one would naturally expect that the majority of appeals would be filed by medicare members themselves. yet the oig found that 85% of all appeals were filed by providers.55 this is likely explained by the significant financial interest providers have in the outcome of appeals, particularly for medicare patients in need of treatment in acute and post-acute settings. the average provider filed six appeals.56 only 11% of the appeals were filed by actual medicare members.57 some providers filed appeals so frequently that the oig created a special category to identify them. the oig designated providers who filed at least fifty appeals in a fiscal year as “frequent filers.”58 incredibly, ninety-six providers fell into this category,59 and one provider managed to file 1046 appeals in 2010 alone.60 furthermore, frequent filers actually filed an even greater number of appeals since at least some of their appeals were approved at levels 1 or 2 and never reached an alj. the high percentage of appeals filed by providers points to a significant problem with the medicare appeals process. providers with claims lacking true merit have little inducement to accept level 2 denials by qics or ires. alj staff indicated that providers are incented to appeal “every payment denial” since the actual cost of an appeal is minimal, and there is a statistical likelihood of a favorable 54 oig report, supra note 2, at 8. 55 id. 56 id. to round out the total, 3% of the appeals were filed by state medicaid agencies, and around 1% were classified by the oig as “unknown.” id. 57 id. 58 id. 59 id. 60 id. 76 indiana health law review vol. 12:1 decision.61 due to the sheer number of frequent filers, the decision to appeal every treatment denial is likely built into the business model as well as the policies and procedures of many providers. this fact is troubling since appellants with meritless claims or those that lack medical necessity are motivated to appeal denials and game the system until a favorable decision is reached. in essence, the more often these providers dip their buckets into the well of medicare appeals, the greater the likelihood they will come up with medicare dollars. in order to curb this abuse of the appeals process by frequent filers and other providers, the oig recommended that omha seek statutory authority to implement a “modest filing fee” for appellants.62 to make the fee fair and effective, the oig suggested that omha create a scaled fee that is based on the dollar amount at issue in the appeal.63 the oig also noted that the filing fee should not apply to beneficiaries because providers have greater financial resources than the average medicare enrollee. these are excellent proposals by the oig that should, if implemented, counteract the abuse of the appeals process by some providers. 2. cms participation in appeals the oig found that cms participated in 10% of level 3 appeals in 2010.64 cms has the option to participate in alj appeals, and may do so as either a participant or a party. however, cms rarely chose to participate as a party, which would allow it to submit evidence, call or cross-examine witnesses, and appeal to the mac.65 when cms chose to participate, it provided testimony in 61% of appeals and submitted position papers to the aljs in the remaining 61 id. at 9. 62 id. at 19. 63 id. 64 id. at 13. 65 see 42 c.f.r. § 405.1012(c) (2014). 2015 peeking behind the robes 77 39%.66 appellants were 16% less likely to prevail when cms was involved in an appeal.67 alj staff cited several benefits from cms participation in appeals. the primary benefit appears to be an improved relationship between both agencies. alj staff also indicated that cms often provided them with “needed information”68 and helped them understand the importance of including specific detail in decisions and position papers to aljs.69 cms intends to join more appeals as a party, rather than as a participant, to allow cms to better present its position on certain issues being appealed.70 due to the apparent benefits of collaboration, the oig recommended that cms expand its participation in alj appeals.71 the oig also instructed cms to strategically decide which types of appeals most warrant cms participation, such as part a hospital appeals or appeals from frequent filers.72 finally, cms was urged to create formal participation guidelines, including the specific scenarios to determine whether to participate in an appeal as a party or as a participant.73 the author concurs with these oig recommendations. more frequent involvement in appeals by cms will improve the reliability and accuracy of alj decisions. and as i will discuss in section iv.a., infra, it will assist aljs who frequently have difficulty interpreting and applying complex medicare guidelines and regulations. 3. accepting new evidence medicare regulations are clear that aljs may only consider new evidence that was not proffered during level 2 66 oig report, supra note 2, at 13. 67 id. 68 the oig report failed to include any examples of the “needed information” that cms provided. 69 oig report, supra note 2, at 14. 70 id. 71 id. at 19. 72 id. 73 id. at 20. 78 indiana health law review vol. 12:1 if “good cause” exists for submitting the evidence.74 absent good cause, the evidence must be excluded and the alj cannot consider it.75 despite these unambiguous standards, the oig found that aljs typically accepted new evidence whenever it was submitted. the author has also found many aljs to be suspect in their application of the good cause standard. often, over repeated objections, aljs admit new evidence by claiming that the objecting party was not “harmed” by the evidence. to address this issue, the oig charged omha and cms to revise the regulations to “include additional examples as well as factors for aljs to consider when determining good cause.”76 following the oig report, cms revised its claims processing manual in june 2013 to include conditions and examples of good cause for enrollees, providers, and suppliers.77 although this guidance is not in the binding form of regulations, it provides much needed direction to aljs and parties to an appeal. 4. additional oig recommendations the oig issued additional recommendations at the conclusion of its report. first, the oig urged omha and cms to work together to provide “coordinated training” on an annual basis to aljs and qics on medicare policies.78 through this measure, the oig hopes to increase the consistency between level 2 and level 3 appeals.79 one area of focus that the oig identified was part a hospital appeals where aljs reversed qics in nearly three-quarters of appeals.80 second, omha and cms should seek statutory authority to postpone appeals from appellants who are concurrently being investigated for fraud.81 the decision to 74 42 c.f.r. § 405.1028(a) (2014). 75 see 42 c.f.r. §§ 405.1028(c), 405.1030(e) (2014). 76 oig report, supra note 2, at 18. 77 see mcpm, supra note 29, at §§ 240.2-.4. 78 oig report, supra note 2, at 17. 79 id. 80 id. 81 id. at 18. 2015 peeking behind the robes 79 postpone appeals should only be made by omha and cms staff that are not directly responsible for deciding appeals. and third, omha should determine if “specialization” by aljs would improve the efficiency of level 3 appeals.82 but specialization, the oig noted, may complicate the statutory requirement to have appeals assigned randomly among aljs.83 iv. major deficiencies with administrative law judges in the course of conducting this study, the oig was able to unearth several issues with medicare aljs and level 3 appeals that need to be corrected. these problems, as discussed in section iii, have relatively easy solutions. they also do not indicate any systemic issues with aljs or omha. but the oig did manage to identify other alj deficiencies that can be classified as “major” problem areas. the oig failed, however, to explore these deficiencies in depth. section iv will address these issues. a. knowledge, expertise, and competency of aljs the oig found that aljs reversed level 2 decisions by quality independent contractors (qics), and decided fully in favor of appellants, in 56% of appeals.84 and an additional 6% of alj decisions were partially favorable to appellants.85 this overturn rate of a lower adjudicatory body is extremely high. in an analysis of data from civil cases in federal court from 1988-97, for example, only 18% of cases were reversed on appeal.86 a similar analysis of appeals from civil cases in state courts found a reversal rate of just 32.1%.87 the 56% reversal rate by aljs therefore 82 id. at 19. 83 id. 84 id. at 9. 85 id. 86 see theodore eisenberg & michael heise, plaintiphobia in state courts? an empirical study of state court trials on appeal, 38 j. legal stud. 121, 129-30 (2009). 87 id. at 130. http://dx.doi.org/10.1086/529150 80 indiana health law review vol. 12:1 raises numerous questions. the oig found several reasons for this high overturn rate, and they reflect directly on the knowledge, expertise, and competency of the aljs hired, trained, and retained by omha. 1. decisions based on “intent” rather than applicable law both qic and alj staff indicated to the oig that aljs tended to interpret medicare policies “less strictly” than qics.88 alj staff also acknowledged that aljs often decided in favor of appellants when the “intent,” but not the letter, of medicare policy was met.89 qics, on the other hand, based their decisions on strict interpretations of medicare guidance. for instance, the oig found cases where qics denied payment because enrollees met only 9 out of 10 criteria in a local coverage determination (lcd).90 clearly cms’ criteria were not met. yet on appeal aljs reversed the qics and approved coverage since the aljs felt that the appellants “met the broader intent of the policy.”91 one must wonder how these aljs divined the “broader intent” of medicare policy when cms’ standard is to only cover treatments that meet the established criteria. in another example, medicare covers home health services under part a when several specific requirements are met. one criterion is that the member must be “homebound” (i.e., confined to his or her home).92 the oig identified appeals where qics denied home health services for enrollees because they failed to meet the homebound requirement.93 yet aljs reversed the qic determinations 88 oig report, supra note 2, at 10-11. 89 id. at 11. 90 id. 91 id. 92 to qualify for home health services, a member must (1) be homebound; (2) need intermittent skilled nursing care, physical or speech therapy, or continuing occupational therapy; (3) be under the care of a physician; and (4) be under a plan of care that has been established and periodically reviewed by a physician. see 42 u.s.c. § 1395f(a)(2)(c) (2014); 42 c.f.r. § 409.42 (2013). 93 oig report, supra note 2, at 11. 2015 peeking behind the robes 81 in some appeals because they considered the services to be reasonable and necessary, while completely ignoring the homebound requirement the loose interpretation of medicare laws, regulations and cms guidance by aljs seriously undermines the financial integrity of the medicare program. and the laissez-faire approach toward medicare law calls into question the role of many aljs as a decision-maker in appeals. aljs are not delegated discretionary authority to override medicare laws and regulations and base their decisions on their own amorphous standards. nor can aljs unilaterally decide to cover treatments, supplies, or prescription drugs when there is controlling medicare authority that dictates otherwise. in fact, “[a]ll laws and regulations pertaining to the medicare and medicaid programs . . . are binding on aljs.”94 any alj who issues a decision that disregards this binding authority has placed his or her own criteria for coverage above lawmakers, cms regulators, and medical experts who developed the parameters for coverage. most aljs understand this and adjudicate appeals accordingly. nonetheless some aljs have utilized a clever way to sidestep medicare’s mandatory authority when they disagree with it. they accomplish this by manipulating the fact that although medicare laws and regulations are binding, cms manuals are not. instead, aljs must afford “substantial deference” to the manuals when they are applicable.95 when drafting a decision that contravenes binding medicare authority, these aljs will conveniently only cite the applicable cms manual. any skilled alj can easily explain why the particular facts of an appealed case are unique and fall outside of the manual’s criteria. with such judicial machinations, the treatment can be covered pursuant to the alj’s own coverage standards. 94 see 42 c.f.r. § 405.1063(a) (2014) (emphasis added). see also 74 fed. reg. 65296, 65327 (december 9, 2009) (“aljs . . . are bound by the medicare statute, cms regulations, cms rulings, and ncds.”) 95 42 c.f.r. § 405.1062(a); 74 fed. reg. 65,296, 65,311 (december 9, 2009). 82 indiana health law review vol. 12:1 the author is aware of such a scenario from a level 3 appeal involving part c. the appeal pertained to an enrollee’s stay in a skilled nursing facility (snf), and both the medicare advantage (ma) plan and maximus—the independent review entity (ire)—had previously denied the enrollee’s appeal because the stay failed to meet medicare’s four criteria for snf coverage. these criteria are stated in medicare regulations and are therefore binding on aljs.96 but the criteria are also repeated in the cms medicare benefit policy manual.97 for whatever reason, the alj wanted the ma plan to cover the snf stay. in a lengthy written decision that reversed the ire, the alj only referenced the cms manual and determined that the snf should be covered since the alj considered the stay to be medically necessary. 2. difficulty understanding medicare law incredibly, many aljs have demonstrated difficulty understanding medicare law and then applying the law to the specific facts of appealed cases. for instance, the oig found that some aljs struggled interpreting the “vague definitions” contained in some medicare policies.98 other aljs indicated that they found it difficult alternating between appeals involving parts a, b, or d of medicare.99 and many alj staff members blamed the variance in alj decisions on the fact that medicare policies were not written “more narrowly or more clearly.”100 these statements from aljs and their staff are surprising for a couple of reasons. first, aljs are not forced to adjudicate appeals and draft their decisions in 96 see 42 c.f.r. §§ 409.30–.33 (2014). 97 see ctrs. for medicare & medicaid servs., medicare benefit policy manual, pub. no. 100-02, ch. 8, § 30 (2014), available at http://www.cms.gov/regulations-and-guidance/guidance/ manuals/downloads/bp102c08.pdf. 98 oig report, supra note 2, at 11. 99 one alj lamented to the oig that “[i]n a month, i will have 10 part a, 10 part b, 3 part d . . . [going] back and forth between different regulations . . . it’s hard.” id. at 11. 100 id. 2015 peeking behind the robes 83 complete isolation sans support staff. instead, omha provides each alj a support “team” to help them sift through medicare regulations and cms guidance.101 each team is comprised of an alj, an attorney, a paralegal, and a hearing clerk.102 the staff attorneys and paralegals are tasked with providing the following assistance to aljs: (i) research appeals, (ii) review and evaluate case files, (iii) prepare briefs and transcripts, (iv) assist in pre-hearing proceedings, (v) draft decisions, and (vi) provide general “assistance.”103 plus aljs also receive assistance from “hearing clerks”104 and other “administrative support staff.”105 second, the majority of medicare claims and, consequently, the majority of medicare appeals, involve similar types of medical care, such as home health, certain dme supplies, or popular part d drugs. aljs should therefore be extremely well versed in adjudicating appeals that involve these common coverage areas. in addition, each alj decides an average of 1,220 appeals per year, based on 2013 figures.106 it logically follows that due to sheer caseload volume, each alj should be intimately familiar with garden-variety medicare claims, denials, definitions, etc., and many of the nuances associated with medicare appeals. the commonality of claims and caseload volume should presumably lessen the concern some aljs expressed in alternating between the different parts of medicare. 101 see office of medicare hearings & appeals, fy 2012 online performance appendix (2013) [hereinafter omha report], at 5, archived at http://perma.cc/p5la-v7gw. 102 id. 103 70 fed. reg. 36,386-04, 36,487 (june 23, 2005). 104 “hearing clerks are responsible for assisting in the hearings and appeals process.” id. 105 omha’s administrative support staff are required to “provide support services to hearings operations staff, and the aljs.” id. 106 in fiscal year 2013, omha employed 65 aljs, who decided a total of 79,303 appeals. this results in average of 1,220 appeals adjudicated per alj. judge nancy griswold, medicare appellant forum, powerpoint slides 10-11, washington, d.c. (february 12, 2014), [hereinafter alj statistics] archived at http://perma.cc/rw32-zehg. 84 indiana health law review vol. 12:1 granted, there are ambiguities in medicare laws and regulations, and some cms policies lack clarity. due to these issues, the oig recommended that omha and cms coordinate on at least an annual basis to identify policies that are unclear.107 cms can then work, as needed, to develop and clarify these policies. as a final note, although omha provides aljs with support personnel, their staff does not include medical directors or clinicians. level 2 qics and ires, on the other hand, have access to such medical experts. the lack of clinicians on staff certainly adds to the difficulty some aljs may experience adjudicating appeals, particularly when the medical necessity of treatments, drugs, or supplies is at issue.108 it also explains why the oig found that aljs tend to place an over emphasis on “testimony and other evidence from treating physicians.”109 3. judicial bias the most egregious issue surrounding alj performance involves judicial bias. the oig found that many aljs appear to have a pre-disposition to approve or deny appeals regardless of the merits of a claim. for instance, one alj stated to the oig: “some [aljs] pay, some deny.”110 another claimed, “i go towards protecting the medicare trust fund[s].”111 the right to an impartial adjudication is a fundamental aspect of due process, and this right applies as equally in an 107 oig report, supra note 2, at 17. 108 medicare specifically excludes coverage for services that are not “reasonable and necessary . . . [f]or the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” 42 c.f.r. § 411.15(k)(1) (2014). this is generally known as medicare’s “medical necessity” standard. 109 oig report, supra note 2, at 12. 110 id. 111 id. medicare is financed through two trust funds: (1) the federal hospital insurance trust fund (which funds part a), and (2) the federal supplementary medical insurance trust fund (which funds part b and part d). see 42 u.s.c. §§ 1395i(a), 1395t(a) (2006). these trust accounts are held by the u.s. treasury. 2015 peeking behind the robes 85 administrative proceeding as it does in a court of law.112 as relevant background, the administrative procedure act of 1946 created the position of administrative law judge within the federal government.113 the apa was passed to ensure fairness and due process in proceedings that involve adjudications by aljs.114 the apa requires that aljs act “in an impartial manner” when presiding at hearings.115 medicare regulations are also clear on this point: “an alj cannot conduct a hearing if he or she is prejudiced or partial to any party or has any interest in the matter pending for decision.”116 the supreme court held that bias exists when a judge demonstrates “such a high degree of favoritism or antagonism as to make a fair judgment impossible.”117 the oig report indicates that some aljs have met this threshold. because judicial bias impacts the integrity of the medicare appeals process and prevents parties from receiving a full and fair review of their claims, omha must consider disciplinary action against aljs who exhibited bias. the disciplinary action should include removal from omha’s panel of aljs for those who have demonstrated “systematic bias” against certain parties. 118 112 see schweiker v. mcclure, 456 u.s. 188, 195 (1982). 113 administrative procedure act of 1946, pub. l. 79-404, 60 stat. 237 (1946) [hereinafter apa]. when the apa was enacted, aljs were called “hearing examiners.” congress changed the title to “administrative law judges” in 1978 when the apa was amended. see act of mar. 27 1978, pub. l. 95-251, 92 stat. 183 (1978) (amending 5 u.s.c. §§ 554(a)(2) 556(b)(3) 559, 1305, 3344, 4301, 5335, 5362, 7251 (2014)). 114 see 5 u.s.c. §§ 551 et seq (2014). 115 5 u.s.c. § 556(b) (2014). 116 42 c.f.r. § 405.1026(a) (2011). see 74 fed. reg. 65296, 65316 (december 9, 2009) (“aljs conduct impartial de novo hearings and this standard of review has not changed” (emphasis added.)) the social security act also implicitly affirms impartial decisions for benefit applicant claims. see 42 u.s.c. §§ 405(b)(1); 1383(c)(1). 117 liteky v. u.s., 510 u.s. 540, 554 (1994). see also porzillo v. dept’t of health and human serv., 369 fed.appx. 123, 129-30 (fed. cir. 2010). 118 kendrick v. sullivan, 784 f.supp. 94, 102 (s.d.n.y. 1992) (“[a]n administrative law judge may not act in a systematically biased manner 86 indiana health law review vol. 12:1 a major difficulty here, however, is evidentiary. it is simply not easy to prove judicial bias. even if probative evidence of bias exists, omha cannot unilaterally remove aljs. omha must comply with merit system protection board (mspb) procedures, which include the opportunity for a hearing before the mspb.119 4. deficient training one reason for the dubious performance and knowledge gaps demonstrated by aljs is deficient training. as a result of its study, the oig felt compelled to recommend that omha and cms “work together to develop and provide training on medicare policies to alj and qic staff.”120 both agencies were charged to “provide training at least annually and focus on policies that tend to be interpreted differently by aljs and qics or among aljs.”121 omha’s formal, written response to the oig recommendation is puzzling. rather than agree with the oig, judge nancy j. griswold, the current chief administrative law judge for omha, countered that omha already conducts an annual education symposium for all aljs, in addition to “high-quality training” on medicare law and policy for new aljs and attorneys.122 in terms of modifying or supplementing omha’s current alj training protocol, judge griswold noted that omha is in deciding cases. rather, an administrative law judge is required to reach decisions by impartially applying the legal rules to the facts established in each case.”) 119 an in-depth discussion of the disciplinary process of the mspb is beyond the scope of this article. briefly, the apa allows a federal agency to take disciplinary action against an alj for “good cause,” which must be established and determined by the mspb. 5 u.s.c. § 7521(a) (2014). evidence of judicial bias would certainly meet the good cause standard. in cases where bias was evident, disciplinary action against an alj can include removal, suspension, reduction in grade, reduction in pay, or a furlough of 30 days or less. see 5 u.s.c. § 7521(b) (2014). if an alj disagrees with an mspb decision, it can be challenged in federal court. 120 oig report, supra note 2, at 17. 121 id. 122 id. at 27. 2015 peeking behind the robes 87 developing a “comprehensive legal assistant training program,” and that “quarterly policy updates” will be provided to aljs and staff.123 based on judge griswold’s response, the only modification to omha’s current training protocol for aljs is that they will receive quarterly policy updates. given the oig’s findings of alj knowledge gaps and deficiencies, this is surprising. moreover, the chief alj was already on notice about deficient alj training at least two years earlier. in a 2010 report, the u.s. government accountability office (gao) analyzed the hiring process for federal aljs.124 in the gao report, omha noted that many of its newly hired aljs lacked the “specialized knowledge important for adjudicating cases in hhs.”125 in the meantime, omha’s chief alj has been blissfully ignorant of the training gaps at omha. in a 2012 fiscal year report to hhs, for example, judge griswold boasted of the “cadre of knowledgeable aljs” on staff. 126 unfortunately, all the deficiencies that the oig identified (i.e., erroneous decisions, difficulty understanding medicare law, and judicial bias) will likely continue until omha recognizes that alj training and education must be significantly upgraded. 123 id. 124 u.s. gov’t accountability office, gao 10-14, results-oriented cultures: office of personnel management should review administrative law judge program to improve hiring and performance management (2010) [hereinafter gao report]. the gao report was based on an analysis of aljs from the social security administration and hhs. 125 id. at 10. 126 omha report, supra note 102, at 1. cms also apparently believes that the status quo is acceptable for alj training. in a 2009 hhs final rule, cms asserted that aljs receive “significant and comprehensive training” about medicare statutes and regulations after they are hired. 74 fed. reg. 65,296, 65,315-316 (dec. 9, 2009). through this extensive training, cms asserts that aljs are armed with the “knowledge and expertise necessary to address the highly complex and technical issues associated with medicare claims appeals.” id. at 65,136. 88 indiana health law review vol. 12:1 b. handling fraud in the course of processing and adjudicating appeals, aljs and their staff often come across evidence indicating a party may have committed fraud against the government. in fact, nearly all alj staff reported to the oig that they suspected fraudulent activity by parties involved in appeals.127 despite these suspicions, many staff members acknowledged that during their tenure with omha they had never made a single fraud referral.128 others claimed to have made at least one referral. overall, a culture of silence appears to predominate omha offices when employees are faced with the opportunity to report fraud. some staff candidly admitted to the oig that they declined to make fraud referrals because they did not consider it a part of their job duties.129 two quotes from different alj staff members are telling: (1) “[i] never referred and do not want to refer anything . . . [it is] not our business here”; and (2) “[t]here is an unspoken rule not to report fraud.”130 due to this spotty record of fraud reporting, the oig recommended that omha “develop policies to handle suspicions of fraud appropriately and consistently and train staff accordingly.”131 judge griswold, omha’s chief alj, issued a formal response to the oig report and its fraud recommendation. judge griswold countered that: omha has conducted anti-fraud training sessions in conjunction with the oig and cms. omha staff has been informed how to report suspicions of fraud regarding an appeal. omha continues to develop policies aimed at providing guidance to aljs and their staff 127 oig report, supra note 2, at 15. 128 id. omha employees, including aljs and their staff, would generally report medicare fraud to either the hhs office of inspector general (the same oig that conducted the present study of aljs) or the u.s. doj. 129 id. 130 id. 131 id. at 19. 2015 peeking behind the robes 89 with respect to handling suspicions of fraud. . . . omha maintains frequent contact with a designated oig office of investigations contact at the national level and has made several fraud referrals.132 judge griswold’s response is quite remarkable in what it fails to address. first, it includes no indication of whether the anti-fraud training and fraud reporting is mandatory for all omha employees, including aljs. second, judge griswold neglects to indicate the frequency of the training.133 third, there is no mention if omha maintains a verification or certification process to ensure that all employees and aljs attend the training. fourth, judge griswold claims that her entire department has made “several” fraud referrals, with no mention of quantity or timeframe.134 because omha provided no actual figures on how many suspected cases of fraud were reported, one can reasonably assume the number is quite low. finally, judge griswold states that alj staff received anti-fraud training and was informed “how” to report fraud. but as the oig indicated, the problem is not that omha employees do not know where or how to report fraud; the problem is that some staff feel they have no affirmative duty whatsoever to identify and report fraud. omha’s apathetic handling of suspected cases of fraud is clearly lacking. hence the directive from the oig that omha “[d]evelop policies to handle suspicions of fraud appropriately and consistently and train staff 132 id. at 29-30. 133 for example, there is no indication whether the training is required only at the time of hiring (i.e., “one-and-done” training), or if it is an annual, recurring requirement for all employees. 134 judge griswold’s claim here leads to numerous, legitimate questions of the time period involved when the fraud referrals occurred. for instance, did omha make “several” (i.e., more than two) fraud referrals during the same week that judge griswold wrote her letter? or has omha made “several” (i.e., more than two) referrals over the past five years? 90 indiana health law review vol. 12:1 accordingly.”135 furthermore, omha’s shortcomings are significant when one considers (1) the fraud policy of the obama administration; (2) whether the failure to report fraud is grounds for termination of employment; and (3) the fraud-reporting obligations that cms imposes on private entities involved in medicare. this section will address each of these areas. 1. obama administration the checkered fraud-reporting record of aljs and their staff runs counter to the express policy of the obama administration. this policy is evidenced through official statements, an executive order, and legislation. prior to president barack obama’s first inauguration in 2009, for example, the obama-biden transition team emphasized the importance of ethics in the federal government. the transition team stated: often the best source of information about waste, fraud, and abuse in government is an existing government employee committed to public integrity and willing to speak out. such acts of courage and patriotism, which can sometimes save lives and often save taxpayer dollars, should be encouraged rather than stifled. we need to empower federal employees as watchdogs of wrongdoing and partners in performance. barack obama will strengthen whistleblower laws to protect federal workers who expose waste, fraud, and abuse of authority in government. 136 the u.s. department of justice (doj) under president obama has also echoed the refrain that federal employees have an obligation to help root out corruption in government and protect taxpayer dollars. in a 2009 135 oig report, supra note 2, at 19. 136 agenda ethics, change.gov, archived at http://perma.cc/yn43yrar. 2015 peeking behind the robes 91 statement to the house of representatives on proposed whistleblower legislation, the doj noted that “the best source of information about waste, fraud, and abuse in government is often a government employee committed to public integrity and willing to speak out.”137 federal employees, the doj added, should serve as “stewards of accountability due to their unique position to observe fraud against the government.” 138 in harmony with these statements, president obama signed an executive order on ethics on his first full day in office on january 21, 2009.139 the order is titled “ethics commitment by executive branch personnel.”140 in addition to a ban on gift-giving from lobbyists, it requires “every appointee in every executive agency” to sign an “ethics pledge."141 also in november 2012, president obama signed the whistleblower protection enhancement act (wpea).142 the wpea built on previous legislation to strengthen and extend whistleblower protections to federal employees who report “gross mismanagement, a gross waste of funds, [or] an abuse of authority.”143 2. federal law federal law requires employees of the federal government to report fraud. in 1990 president george h. w. bush signed an executive order entitled “principles of ethical conduct for government officers and employees,” which outlined fourteen principles of ethical conduct for 137 protecting the public from waste, fraud, and abuse: h.r. 1507, the whistleblower protection enhancement act of 2009: hearing before the h. comm. on oversight and govt. reform, 111th cong. 1 (2009) (statement of rajesh de, deputy assistant att’y gen., u.s. dep’t of justice). 138 id. at 2. 139 exec. order no. 13,490, 74 fed. reg. 4,673 (january 26, 2009). 140 id. 141 id. at 4,673 142 whistleblower protection enhancement act of 2012, pub. l. no. 112-199, 126 stat. 1465 (2012) [hereinafter wpea]. 143 id. at § 102 92 indiana health law review vol. 12:1 government employees.144 these principles were later issued as regulations by the office of government ethics, and are formally known as the standards of ethical conduct for employees of the executive branch.145 the ethical standards “apply to every employee” in federal government,146 and all employees are required to “respect and adhere” to them.147 three of the fourteen principles are of particular relevance here: no. 8 “employees shall act impartially and not give preferential treatment to any private organization or individual.”148 no. 11 “employees shall disclose waste, fraud, abuse, and corruption to appropriate authorities.”149 no. 14 “employees shall endeavor to avoid any actions creating the appearance that they are violating the law or the ethical standards set forth in this part. whether particular circumstances create an appearance that the law or these standards have been violated shall be determined from the perspective of a reasonable person with knowledge of the relevant facts.”150 144 exec. order no. 12,731, 55 fed. reg. 42,547 (october 19, 1990). 145 basic obligation of public service, 5 c.f.r. § 2635.101 (2014) [hereinafter ethical standards] the ethical standards are based on the notion that “[p]ublic service is a public trust.” id. at § 2635.101(a). 146 5 c.f.r. § 2635.101(b) (2014). 147 5 c.f.r. § 2635.101(a) (2014). 148 5 c.f.r. § 2635.101(b)(8) (2014). 149 5 c.f.r. § 2635.101(b)(11) (2014). pursuant to this provision, the u.s. environmental protection agency states that federal employees are “duty bound to report fraud, waste, abuse, and corruption.” office of inspector gen., epa, fraud, waste and abuse: prevention, detection, and reporting for federal, state, local, and tribal administrators, archived at http://perma.cc/e9pv-w4gl. 150 5 c.f.r. § 2635.101(b)(14) (2014). 2015 peeking behind the robes 93 aljs have not only violated these principles, but many appear to act with a deliberate disregard of their duty to disclose fraud when they become aware or suspicious of it. a violation of any one of the ethical standards is prima facie evidence that an individual has “engaged in conduct unbecoming a federal employee.”151 since 1998, federal employees across several government agencies, including hhs, have been fired or suspended for violating these standards.152 hhs regulations, incidentally, also require hhs employees to immediately report any cases of fraud, waste, or abuse that they become aware of.153 based solely on the oig interviews of alj staff, it is impossible to quantify the percentage of aljs and staff who suspected fraudulent activity but violated the ethical standards by not reporting it. but in a government agency with approximately 514 employees154 and that processed 79,303 appeals in 2013,155 it is certainly reasonable to assume that minimally dozens of omha employees were exposed to fraudulent activity by parties involved in appeals. yet despite a legal and ethical obligation to report medicare fraud, it is not occurring. 151 see schifano v. dep’t of veterans affairs, 70 m.s.p.b. 275, 281 (1996). 152 see, e.g., u.s. v. project on gov’t oversight, 839 f.supp.2d 330 (d.d.c. 2012); u.s. v. safavian, 451 f.supp.2d 232 (d.d.c. 2006); suarez v. dep’t of housing and urban dev., 96 m.s.p.b. 213 (2004), aff’d, 125 fed.appx. 1010 (fed. cir. 2005); and mann v. dep’t of health and human serv., 78 m.s.p.b. 1 (1998). 153 see 45 c.f.r. § 73.735-1302 (2014) (“an employee who has information which he or she reasonably believes indicates . . . mismanagement, a gross waste of funds, or abuse of authority . . . shall immediately report such information to his or her supervisor . . . or directly to the office of inspector general.”) 154 see s. 1284, 113th cong. § 112 (2014) (figure based on 2014 appropriations). 155 see alj statistics, supra note 10. 94 indiana health law review vol. 12:1 3. fraud-reporting requirements for private entities involved in medicare the lax commitment by aljs toward identifying and reporting fraud against the government stands in vivid (as well as ironic) contrast to the standards cms imposes on private companies involved in medicare’s part c (medicare advantage) and part d (prescription drug) programs. both cms and omha are affiliate government agencies that report directly to hhs. cms is responsible for oversight of entities offering medicare advantage and prescription drug plans. in this capacity, cms currently requires every “sponsor” of these plans to implement a medicare “compliance program.”156 in order to pass cms muster, a compliance program must minimally include the following components that are related to fraud: • sponsors must report “actual or suspected” cases of fraud;157 156 see 42 c.f.r. §§ 422.503(b)(4)(vi), 423.504(b)(4)(vi) (2014). see also ctrs. for medicare & medicaid servs., u.s. dep’t. of health and human servs., medicare managed care manual, pub. no. 10016, ch. 21 (2013) [hereinafter mmcm], archived at http://perma.cc/wm3w-2z38; medicare & medicaid servs., u.s. dep’t. of health and human servs., prescription drug benefit manual, pub. no. 100-18, ch. 9 (2013) [hereinafter pdbm], archived at http://perma.cc/8c38-zgdw. 157 mmcm, supra note 157, at § 50.3.1; pdbm, supra note 157, at § 50.3.1. cms also mandates that fraud training includes instruction on identifying and reporting “waste” and “abuse.” cms describes “waste” as “the overutilization of services, or other practices that, directly or indirectly, result in unnecessary costs to the medicare program. waste is generally not considered to be caused by criminally negligent actions but rather the misuse of resources.” mmcm, § 20; pdbm, § 20. “abuse” is described as “actions that may, directly or indirectly, result in: unnecessary costs to the medicare program, improper payment, payment for services that fail to meet professionally recognized standards of care, or services that are medically unnecessary. abuse involves payment for items or services when there is no legal entitlement to that payment and the provider has not knowingly and/or intentionally misrepresented the facts to obtain payment.” id. 2015 peeking behind the robes 95 • employees involved in administering part c or part d benefits must receive fraud training within 90 days of initial hire and annually thereafter from plan sponsors. and sponsors must be able to demonstrate to cms that their employees received this training through sign-in sheets, employee attestations, or electronic certification;158 • sponsors must provide fraud training directly to entities that provide treatment to medicare enrollees, such as hospitals, physicians, or skilled nursing facilities;159 otherwise sponsors can provide fraud training materials to these entities; • written policies and procedures that require their employees and corporate officers to report “suspected or actual” fraud violations and compliance concerns;160 • whistleblower protection that apply to any employee who reports fraud “in good faith”;161 and • sponsors must maintain a tracking system to follow any reports of “suspected or detected” incidents of fraud.162 all of these standards are issued as mandates from cms. failure to implement an adequate compliance program can result in cms fines, sanctions, or even a ban or prohibition on offering a medicare program. with such 158 mmcm, supra note 157, at § 50.3.2; pdbm, supra note 157, at § 50.3.2. see also 42 c.f.r. § 422.503(b)(4)(vi)(c) (2014). 159 mmcm, supra note 157, at § 50.3.2; pdbm, supra note 157, at § 50.3.2. (cms also requires training on other federal laws, such as the health insurance portability and accountability act, the false claims act, the anti-kickback statute, and the physician self-referral law). 160 mmcm, supra note 157, at § 50.4.2; pdbm, supra note 157, at § 50.4.2. 161 mmcm, supra note 157, at § 50.4.2; pdbm, supra note 157, at § 50.4.2. 162 mmcm, supra note 157, at § 50.4.2; pdbm, supra note 157, at § 50.4.2. 96 indiana health law review vol. 12:1 robust fraud-reporting requirements for employees of medicare advantage and part d plans, it is nonsensical that omha does not impose such affirmative obligations on its aljs and staff. in fact, cms even requires its own adjudicators of redeterminations to “deny or reduce payment” when they believe items or services were not rendered or were not rendered as billed.163 4. deterrent effect of fraud reporting perhaps lost in this discussion of the failure by aljs and their staff to report fraud is consideration of the deterrent effect of fraud reporting. health care fraud is a national dilemma. it is estimated that medicare fraud alone costs the program between $60 billion and $90 billion each year.164 medical providers and suppliers who are attempting to game the system with fraudulent claims will be less likely to appeal denials if they are aware that aljs and their staff will diligently report any cases of suspected fraud. millions of dollars could potentially be saved if providers stopped pushing bogus medical claims through the appeals system because they realized they were likely to be reported. in fiscal year 2012 alone, the federal government won or negotiated over $3 billion in health care fraud judgments and settlements.165 from these recoveries, $2.4 billion dollars were transferred back into the medicare trust funds.166 aljs can and must play a greater role in deterring medicare fraud by fulfilling their reporting obligations. 163 see mcpm, supra note 29, at § 280.4. 164 jim suhr, report: health care fraud cases hit high last year, yahoo (jan. 15, 2014), http://perma.cc/28q9-fm64. 165 u.s. dep’t of health & human servs. & dep’t of justice, health care fraud and abuse control program: annual report for fiscal year 2012 1 (2013), archived at http://perma.cc/s53l-x6tq. 166 id. at 8. 2015 peeking behind the robes 97 c. appeal record during the course of an appeal in any adjudicatory proceeding, it is critical that an appeal record be logically compiled and organized for the parties and the adjudicator. from its study, the oig found that alj staff often received “incomplete or disorganized” appeal files from qualified independent contractors (qics) during level 2 appeals.167 deficient appeal files, in turn, led to delays and “inefficiencies” in the appeals process since aljs were forced to remand the appeals to qics, request additional information, or reorganize the case files.168 one major weakness with medicare’s appeals process is that qic appeal files are organized and processed electronically, while omha’s aljs only accept paper files. the process for qics to convert electronic files to a paper format is resource intensive and prone to error. to remediate this problem, the oig recommended that omha and cms make case files “more consistent” through the various medicare appellate levels.169 the oig felt this could be accomplished by finalizing and enforcing a memorandum of understanding (mou) between the two departments that specifies how case files are organized.170 the oig also recommended that omha “accelerate” an initiative to transition from paper to electronic files.171 1. records forwarded to the medicare appeals council poorly-managed case files are a major problem for aljs. but the oig report did not fully explore the depth and breadth of this issue. the oig focused primarily on the condition of the appeal record that aljs receive from qics. but a similar, if not greater, problem exists with the content and organization of the appeal files that aljs forward to the level 4 medicare appeals council (mac). as evidence, 167 oig report, supra note 2, at 14. 168 id. 169 id. at 18. 170 id. 171 id. 98 indiana health law review vol. 12:1 one can access countless cases that were appealed to the mac, but that could not be adjudicated due to the utter disarray of alj appeal files. the appeal record is of critical importance during a level 4 appeal since the mac must decide each appeal “on the record” (i.e., without a hearing).172 a snapshot of this problem is found in a 2009 mac case that involved a rather straightforward issue of whether a physician who had been excluded from federal health care program participation was eligible to be reimbursed by medicare.173 the appeal record that the alj forwarded in this case to the mac was so deficient that the mac was precluded from making any specific citation to the appeal record. the alj essentially forwarded an appeal record that appeared to be a quick dump of a case file. the mac’s description of the appeal record is comical: [t]he record in this case is in disarray. in its current state, the record consists of ten large manila folders, secured only by rubber bands, containing unbound documents neither paginated nor more than generically indexed. the documentation itself includes pages which are in no apparent sequential order, folded, upside down, and/or blank side up, envelopes, parts of envelopes as well as a diskette in an unsecured envelope purporting, based on the writing on the diskette, to be a ‘qic copy’ of a ‘correction to letter.’ the alj’s reference to the exhibits in his order is no clearer, simply consisting of twenty-three footnote citations to ‘exhs. appendix a.’174 172 there are some limited exceptions, however. the mac will permit hearings for appeals that raise important issues of law, policy, or facts that can’t be determined solely from the record. see 42 c.f.r. § 405.1124 (2014). 173 see in re breton morgan, m.d., 2009 wl 5764312 (m.a.c. nov. 5, 2009). 174 id. at *4 (footnote omitted). 2015 peeking behind the robes 99 due to the shoddy and cluttered state of the appeal record, the mac remanded the case to the alj, along with detailed instructions on how to organize the record. the mac felt compelled to instruct the alj to “[c]hronologically organize, secure, paginate and index all exhibits admitted as evidence in the record”; and to “[i]dentify, organize, secure, paginate and index the documentation submitted with the appellant’s request for an alj hearing, which the alj directed should be excluded.”175 one would not expect these elementary instructions from the mac to be necessary. but this case was not an anomaly. in a 2010 appeal, for example, the mac was precluded from adjudicating an appeal because it was unable to retrieve a complete appeal record from the alj.176 specifically, “exhibit 7” was missing from the record. the mac’s narrative of the situation borders on the absurd: the alj’s exhibit list identifies exh. 7 as a ‘binder.’ there is no binder in any of the exhibit boxes provided to the council. in an effort to obtain the missing exhibit, the office contacted [omha] and was informed that exh. 7 may have been recorded on multiple cds. while the record contains a single cd identified only as ‘alj # 1-474904598***’ with ‘advancemed corporation’ on the right side of the disk, it is not marked as exhibit 7 nor does it contain multiple cds. . . . this cd was provided to the council after the remainder of the case record was received. in any event, in attempting to review the contents of the cd, a message appeared indicating that the disk was encrypted; the message stated the name of the person at advancemed to contact for the password. efforts were made to obtain the password from the appellant, but this office 175 id. at *5-6. 176 see felicia sankey, m.d., no. m-10-856, 2010 wl 7342938 (m.a.c. dec. 17, 2010). 100 indiana health law review vol. 12:1 was informed that the contact person was no longer employed by the appellant and that no one else would have that information. thus, the council has not been able to ascertain whether the information on this cd consists of part or all of exhibit 7.177 the ineptitude demonstrated by aljs and staff when compiling and forwarding the appeal record is certainly not limited to these two cases. a westlaw query yields a seemingly endless number of remands to the alj because the mac could not view or retrieve the appeal record.178 due to the frequency of these remands, the mac uses cutand-paste boilerplate in its orders indicating that a deficient appeal record prevented them from issuing a decision. organized and comprehensive appeal records are clearly critical to ensure that parties have appeals decided in a timely manner. the oig therefore overlooked a significant 177 id. at *1, n. 1 (citation omitted). 178 see, e.g., robert w. levin, m.d., no. m-12-433, 2012 wl 3067972 (m.a.c. may 16, 2012); a fitting experience mastectomy shoppe, no. m-12-1222, 2012 wl 4482710 (m.a.c. aug. 23, 2012); jewish hospital & st. mary’s healthcare, no. m-12-960, 2012 wl 4482737 (m.a.c. aug. 24, 2012); masshealth & n.y. office of medicaid inspector gen., no. m-12-1108, 2012 wl 6066035 (m.a.c. sept. 7, 2012); gordian medical, inc., no. m-11-2723, 2012 wl 4358991 (m.a.c. aug. 10, 2012); prima care medical group, m-11-567, 2012 wl 1980616 (m.a.c. mar. 23, 2012); advance diabetes treatment centers, no. m10-1376, 2012 wl 1793277 (m.a.c. mar. 5, 2012); int’l rehabilitative scis., inc., no. m-11-1220, 2012 wl 3164410 (m.a.c. may 31, 2012); kingston of ashland, no. m-11-765, 2011 wl 6960310 (m.a.c. may 20, 2011); sunrise family foot care ctr., no. m-11-976, 2011 wl 6025971 (m.a.c. mar. 7, 2011); m.a.b., no. m-10-1206, 2011 wl 5080370 (m.a.c. feb. 10, 2011); bionicare med. techs., inc., no. m-09-414, 2011 wl 7102455 (m.a.c. sept. 7, 2011); mane med. equip. & supplies, inc., no. m-10-1425, 2011 wl 3668258 (m.a.c. jan. 13, 2011); h.r., no. m11-1867, 2011 wl 7145355 (m.a.c. oct. 11, 2011); west universal rehab, no. m-11-221, 2011 wl 6968104 (m.a.c. july 8, 2011); l.j.k., no. m-10-1745, 2010 wl 7342928 (m.a.c. dec. 17, 2010); j.a.c., no. m10-1386, 2010 wl 7209415 (m.a.c. nov. 17, 2010); kinetic concepts, inc., no. m-2009-884, 2010 wl 2831009 (m.a.c. feb. 25, 2010); int’l rehabilitation scis., inc., no. m-10-1970, 2010 wl 7342932 (m.a.c. dec. 17, 2010). 2015 peeking behind the robes 101 issue that requires remediation when it failed to analyze the appeal records that aljs forward to the mac. v. conclusion the oig was successful in identifying numerous deficiencies with medicare’s aljs and the third level of medicare appeals. but the oig report failed to adequately address the magnitude of the deficiencies and the appropriate remedial action necessary to correct them. the core problem involves the competency and performance of the aljs themselves. omha’s panel of aljs includes judges who are simply not fit to hold hearings and adjudicate appeals. if aljs exhibit bias, disregard binding authority, or have (with any modicum of experience) difficulty understanding medicare laws and regulations, then those individuals should simply not serve as triers of fact and decision-makers. part of the problem lies at the feet of the office of personnel management (opm). opm should not send alj candidates to ohma who have little, if any, prior experience with medicare. but omha merits a greater amount of culpability for providing substandard training and follow-up for the aljs who are already on staff, and omha must accept responsibility for keeping aljs on panel who have demonstrated bias against specific types of individuals or parties. omha must attempt to identify these aljs, and then initiate the appropriate process with the merit systems protection board to discipline or remove them.179 medicare enrollees, plan sponsors, providers and suppliers deserve nothing less than fair and impartial adjudications. omha must also develop better fraud training and require aljs and staff to attend training at the time of hire and at least annually thereafter. many aljs simply do not understand nor accept their fraud-reporting obligations. as employees of hhs, they must recognize that they are stewards of the medicare trust funds, and they must be 179 see 5 u.s.c. § 556(b) (2014). 102 indiana health law review vol. 12:1 perceptive of individuals who are depleting these funds through fraudulent and abusive schemes. finally, omha must assist with, rather than hinder, the efficiency of medicare’s appeals process. this can be accomplished by improving its internal controls and forwarding only formatted and complete appeal records to the medicare appeals council (mac). help that hurts: how dol’s home care rule harms people with disabilities and caregivers emily munson, jd, ma* i. home care workers and the flsa ........................... 435 ii. challenges to the companionship exemption ....... 436 a. legislative challenges .............................................. 437 b. challenges through litigation ................................. 439 c. administrative challenges ....................................... 444 d. home care association challenge ........................... 448 iii. effects for recipients of care .............................. 451 a. delivery of services ................................................... 451 b. state implementation ............................................... 453 c. harms to recipients of care ..................................... 455 iv. consequences for home care workers ................ 460 a. home care worker representation ......................... 461 b. pragmatic effects for home care workers .............. 466 v. conclusion ................................................................. 470 people with disabilities and their caregivers work together every day. in addition to the obvious—caregivers assisting clients with disabilities in performing activities of daily living—the two groups have frequently come together in support of a cohesive policy agenda.1 in 2011, when the department of labor (dol) issued a notice of proposed *ll.m. candidate, 2016, indiana university robert h. mckinney school of law. i would like to thank melissa l. keyes, j.d., m.s., for her diligent editing. of course, any errors that remain are my own. 1 adapt disability rights activists and seiu home care attendants tell congress: community choice is a right, pr newswire (apr. 29, 2009), http://www.prnewswire.com/news-releases/adaptdisability-rights-activists-and-seiu-home-care-attendants-tell-congresscommunity-choice-is-a-right-62029822.html [http://perma.cc/g5qpxqlu]; edgar walters, conservatives join push to pay care workers more, tex. trib. (mar. 3, 2015), http://www.texastribune.org/2015/ 03/03/among-conservatives-push-pay-attendants-more/ [http://perma.cc/ vgq7-awfm]. http://dx.doi.org/10.18060/3911.0023 434 indiana health law review vol 13:2 rulemaking to limit the companionship exemption to the fair labor standards act (flsa), the two groups’ interests diverged. advocacy groups for home care workers, as well as lobbying groups for the minorities that comprise a significant portion of the home care worker pool, had been clamoring for minimum wage and overtime protections for years. to these groups, the denial of flsa protections to workers constituted an injustice.2 however, disability rights groups were concerned that the recipients of care–also historically marginalized–lacked the resources, both individually and governmentally, to cover the benefits home care workers desired, as congress itself recognized when debating the companionship exemption.3 the disability community argued that the dol’s failure to first ensure adequate infrastructure to support flsa protections for workers jeopardized those receiving care.4 part i of this paper begins by exploring how the federal government has classified domestic workers since the inception of the flsa. part ii explores the genesis of the companionship exemption, as well as the challenges it has faced from the legislative, judicial, and administrative branches of government. finally, the most recent challenge to the dol’s interpretation of the home care rule, home care ass’n of america v. weil,5 is discussed. subsequent parts of the paper focus on the harm that will result from implementation of the new home care rule. part iii describes why the well-being of people with disabilities is jeopardized by implementation of the rule, and details how states are grappling with the new regulatory requirements. 2 nelp applauds historic decision to uphold minimum wage and overtime rights for home care workers, nelp (aug. 21, 2015), http://www.nelp.org/news-releases/nelp-applauds-historic-decision-touphold-minimum-wage-overtime-rights-for-home-care-workers/ [http://perma.cc/8tv7-dvgt]. 3 see 119 cong. rec. 24,797 (1973) (statement of sen. dominick); id. at 24,789 (statement of sen. johnston). 4 dol proposes changes to companionship exemption hurt people with disabilities!, adapt, http://www.adapt.org/main/dol [http:// perma.cc/m2a3-3zch] (last visited apr. 11, 2016). 5 home care ass’n. of am. v. weil, 78 f. supp. 3d 123, 128 (d.d.c.), rev'd sub nom., 799 f.3d 1084 (d.c. cir. 2015). 2016 435 help that hurts: how dol’s home care rule harms people with disabilities and caregivers part iv explains why the rule will not actually benefit home care workers, and even may leave some worse off than before. i. home care workers and the flsa in 1938, congress enacted the flsa.6 the flsa was deemed necessary to address “labor conditions detrimental to the maintenance of the minimum standard of living necessary for health, efficiency, and general well-being of workers.”7 its protections included minimum wage and overtime standards.8 however, not all employees benefited.9 flsa excluded from its minimum wage and overtime protections certain classes of worker, including domestics and other workers traditionally performing services in the home.10 as such, those workers providing care for the elderly and disabled were not protected by the flsa at its inception. in 1961 and 1966, the flsa was amended to provide coverage to certain additional employees through “enterprise coverage.”11 for the first time, workers would receive minimum wage and overtime protections based on the size of their employer, as opposed to the specific nature of their individual work. thus, if a domestic worker was employed by an agency (or other enterprise) with gross annual sales of $250,000 or more, she was entitled to receive the minimum wage and additional compensation for overtime.12 however, these protections were short-lived. less than a decade later, in 1974, congress explicitly exempted several categories of domestic employees from 6 codified as amended at 29 u.s.c. § 201 et seq. (2016). 7 codified at 29 u.s.c. § 202(a) (2016). 8 29 u.s.c. §§ 206-207 (2016). 9 in fact, only about one-fifth of the american labor force was covered by flsa. jonathan grossman, fair labor standards act of 1938: maximum struggle for a minimum wage, u.s. dep’t lab., http://www.dol.gov/oasam/programs/history/flsa1938.htm [http:// perma.cc/a5d3-qcmj] (last visited apr. 11, 2016). 10 see 29 u.s.c. §§ 201-219 (2016). 11 see 29 u.s.c. § 203(r) ̶ (s) (2016). 12 see fair labor standards amendments of 1966, pub. l. no. 89601, 80 stat. 830, 836 (1966) (current version at 29 u.s.c. § 203(s)(1) (2016) (current limit is $500,000)). 436 indiana health law review vol 13:2 flsa coverage by implementing the “companionship exemption.” exempted companions included “any employee employed on a casual basis . . . to provide babysitting services,”13 as well as those “employed . . . to provide companionship services for individuals who (because of age or infirmity) are unable to care for themselves.”14 the secretary of labor was left to define the specifics.15 in 1975, the dol reported receiving a variety of comments in response to its proposed implementing regulations, from groups as diverse as law firms to working mothers.16 based on these comments, the dol amended the final rule to: clarify that individuals engaged in a home business are not domestic service employees, simplify recordkeeping mandates for live-in caregivers, and describe timekeeping methods.17 perhaps most controversial, wage and hour division administrator betty murphy determined that third parties could avail themselves of the companionship exemption since the exemption applies to “any employee.”18 this meant that domestic service workers affiliated with agencies constituting enterprises under the flsa would no longer be entitled to overtime and minimum wage protections. ii. challenges to the companionship exemption the companionship exemption has subsequently been challenged through multiple channels. while no congressional proposals have yet been successful in amending the exemption, that has not stopped senators and representatives from offering proposed amendments. other challenges have come from home care workers seeking flsa protection through litigation, as well as through administrative rulemaking efforts. this section provides a brief summary of how the exemption has been challenged since 1975. 13 29 u.s.c. § 213(a)(15) (2016). 14 id. 15 id. 16 extension to domestic service employees, 40 fed. reg. 7404 (feb. 20, 1975) (codified at 29 c.f.r. pts. 516, 552). 17 id. at 7405. 18 id. 2016 437 help that hurts: how dol’s home care rule harms people with disabilities and caregivers a. legislative challenges most recently, efforts to amend the flsa to cover home care workers have come in the form of proposed legislative amendments. in 2007, representative lynn woolsey introduced the fair home health care act in the house (house bill 3582).19 the short bill defined “casual basis” domestic service employment as “irregular or intermittent” and provided that it is neither performed by an individual whose vocation is the provision of companionship services, nor may it exceed an aggregate twenty hours per week.20 senator tom harkin introduced a similar bill in the senate.21 both bills were referred to committees, where they remained.22 senator robert casey and representative linda sanchez introduced the direct care workforce empowerment act in 2010 where, again, the bills’ primary purpose was limiting the companionship exemption by narrowing the scope of casual basis employment. 23 specifically, the bills would require casual employment to be “irregular or intermittent,” and disallowed such employment from being performed by an individual in a vocational capacity.24 the bills further provided that “[e]mployment is not on a casual basis, whether performed for one or more family or household employers, if such employment for all such employers exceeds [twenty] hours per week in the aggregate.”25 the bills also directed the secretary of health and human services to create a data 19 h.r. 3582, 110th cong. § 2 (2007). 20 id. § 2. 21 s. 2061, 110th cong. (2007). notably, cosponsors of this bill included senators clinton and obama. as will be discussed, the clinton and obama administrations also attempted to limit the companionship exemption through administrative action. 22 h.r. 3582fair home health care act, congress.gov, https://www.congress.gov/bill/110th-congress/house-bill/3582 (last visited feb. 27, 2016); s.2061 -fair home health care act of 2007 , congress.gov, https://www.congress.gov/bill/110th-congress/senatebill/2061 (last visited feb. 27, 2016). 23 s. 3696, 111th cong. (2010); h.r. 5902, 111th cong. (2010). 24 s. 3696, 111th cong. (2010); h.r. 5902, 111th cong. (2010). 25 s. 3696, 111th cong. (2010); h.r. 5902, 111th cong. (2010). 438 indiana health law review vol 13:2 collection and monitoring program, national advisory council on the direct care workforce, and three-year grant program designed to improve recruitment, retention, and education of the direct care workforce.26 neither bill made it out of committee.27 the following june, senator casey and representative sanchez tried again, introducing the direct care job quality improvement act of 2011 into their respective houses.28 these bills sought to clarify that the term “casual basis in domestic service employment to provide companionship services” means intermittent employment that is “not performed by an individual – (1) whose vocation is the provision of companionship services; or (2) who is employed by an employer or agency other than the family or household using their services.”29 in the event that a caregiver works for a family or individual more than five hours per week or for more than twelve weeks per year, the caregiver would not be considered to be working on a casual basis.30 in addition to flsa amendments, the bills also called for the creation of a workforce monitoring program, a data sharing program, reports on the adequacy of long-term care support for medicaid purposes, and multiple grant programs.31 again, the bills were stuck after being referred to committee.32 in response to dol’s proposed narrowing of the companionship exemption, representative lee terry introduced the companionship exemption protection act.33 26 s. 3696, 111th cong. (2010) §§ 4-5; h.r. 5902, 111th cong. (2010) §§ 4-5. 27 h.r. 5902direct care workforce empowerment act, congress.gov, https://www.congress.gov/bill/111th-congress/housebill/5902 (last visited feb. 27, 2016); s.3969 -direct care workforce empowerment act, congress.gov, https://www.congress.gov/bill/111thcongress/senate-bill/3696/text (last visited feb. 27, 2016). 28 h.r. 2341, 112th cong. (2011); s. 1273, 112th cong. (2011). 29 h.r. 2341, § 3. 30 id.; s. 1273, § 3. 31 id. §§ 4-6; id. §§ 4-6. 32 h.r. 2341-direct care job quality improvement act of 2011, congress.gov, https://www.congress.gov/bill/112th-congress/housebill/2341/text (last visited feb. 27, 2016); s.1273 -direct care job quality improvement act of 2011, congress.gov, https://www.congress.gov/bill/ 112th-congress/senate-bill/1273/related-bills (last visited feb. 27, 2016). 33 h.r. 3066, 112th cong. (2011). 2016 439 help that hurts: how dol’s home care rule harms people with disabilities and caregivers the act proposed stripping the secretary of labor of the authority to define and delimit the exemption.34 a similar bill was introduced in the senate by senator mike johanns.35 ultimately, neither was successful. b. challenges through litigation as individuals with disabilities began leaving institutions for group homes, ambiguity remained as to whether the companionship exemption applied to community-based settings that were not necessarily private homes (e.g., group homes owned by a provider and largely funded by the state). even before the supreme court’s seminal olmstead decision,36 courts had begun providing greater clarity regarding the companionship exemption’s applicability. one of the first cases to address the issue was lott v. rigby.37 there, house parents at stephens county independent group residence for the mentally retarded petitioned the court for overtime compensation. however, the court determined that the companionship exemption only applied to those services provided in a private home.38 because the residence was publicly funded, the house parents could not be domestic service employees.39 numerous cases followed. in linn v. developmental services of tulsa, inc., the court held that to determine whether a home was private, the court should focus on the elements of control, such as whether the service provider furnished the residence, maintained a set of keys, and paid rent, as well as whether residents were related and were offered a setting similar to an institution.40 in madison v. resources for human development, inc., the court deemed the fact that clients did not live in the home prior to becoming clients of the service provider a significant factor in 34 id. 35 s. 3280, 112th cong. (2012). 36 olmstead v. l. c. ex rel. zimring, 527 u.s. 581 (1999). 37 lott v. rigby, 746 f. supp. 1084 (n.d. ga. 1990). 38 id. at 1088. 39 id. 40 see linn v. developmental servs. of tulsa, inc., 891 f. supp. 574 (n.d. okla. 1995). 440 indiana health law review vol 13:2 determining whether the home was private.41 in johnston v. volunteers of america, inc., the tenth circuit ruled that the employer bears the burden of proving that its employees meet the exemption.42 in 2004, the tenth circuit revisited the issue in welding v. bios corp.43 there, a group of caregivers for individuals with developmental disabilities in multiple homes alleged that their employer violated flsa by improperly availing itself of the companionship exemption. the court determined that housing units are part of a “continuum,” and “key inquiries” in determining where on that continuum the unit lies “are who has ultimate management control of the living unit and whether the living unit is maintained primarily to facilitate the provision of assistive services.”44 factors to be addressed are: whether the recipient of care lived in the home prior to becoming a client of the provider; who owns the home, which “is significant because it evidences control”; who maintains the home by paying the mortgage, utilities, and food; whether the recipients of care would continue living in the home if you no longer received services from the provider; the difference in the relative values of services provided and the total cost of the living unit; and whether the provider uses any part of the home for business purposes.45 “[n]o single factor is dispositive, [though] some may be more important than others.”46 two years later, the dol adopted the welding factors as its own.47 a second area of litigation involving the companionship exemption challenged the notion that certain home care workers were untrained personnel. in mccune v. oregon senior services division, a group of live-in caregivers alleged that, as certified nursing assistants (cnas), they met the 41 see madison v. res. for human dev., inc., 39 f. supp.2d 542 (e.d. pa. 1999). 42 see johnston v. volunteers of am., inc., 213 f.3d. 559 (10th cir. 2000). 43 welding v. bios corp., 353 f.3d. 1214 (10th cir. 2004). 44 id. at 1219. 45 id. at 1219-20. 46 id. at 1219. 47 rebecca m. fowler, home healthcare workers and the fair labor standards act, 1 j. health & life sci. l. 107, 122 (2008). 2016 441 help that hurts: how dol’s home care rule harms people with disabilities and caregivers companionship exemption exception for trained personnel.48 the appellants had received 60 hours of training in order to achieve cna certification.49 appellants further requested that the court consider crediting them with additional training that had been received directly from the physicians of those receiving care.50 like the district court, the ninth circuit rejected this argument because, under oregon law, the tasks that physicians trained the cnas in were outside the scope of cna competence and were instead the duties of a licensed nurse.51 the court determined that it would be inappropriate to reward appellants for acting outside the scope of their authority.52 moreover, it recognized that asking the state to account for on-the-job training and constantly reassess their employees for development would be “an administrative nightmare.”53 the seventh circuit faced a similar challenge from a home health aide in cox v. acme health services, inc.54 the appellant had received 105 hours of training to become certified as a cna, and completed additional training to achieve certification as a home health aide.55 maintaining home health aide certification required a minimum of 12 hours continuing training each year.56 in bringing her claim for unpaid overtime wages, cox argued “her training and duties as a home health aide were akin to the training and duties of a registered or practical nurse within the meaning of the exception to the flsa’s exemption for ‘companionship services.’”57 the court opined that cox had “received only a fraction of the training received by registered or practical 48 mccune v. or. senior servs. div., 894 f.2d 1107 (9th cir. 1989). the group also alleged that because they provide general housekeeping services to clients, essentially performing the collective duties of cooks, maids, nurses, and other workers entitled to flsa coverage, they, too, should be covered by the flsa. id. at 1109. 49 id. at 1113. 50 id. at 1111. 51 id. 52 id. 53 id. 54 cox v. acme health servs. inc., 55 f.3d 1304 (7th cir. 1995). 55 id. at 1307. 56 id. at 1306. 57 id. at 1308. 442 indiana health law review vol 13:2 nurses.”58 additionally, the requirements for becoming a registered or practical nurse were more stringent, and included statutorily-mandated training in areas from biological sciences to nursing theory.59 although cox had obtained training beyond the mandatory seventy-five hours necessary to be a home health aide in indiana, it was “of no consequence” because the tasks she was performing did not require the additional training.60 the court held that to avail oneself of the trained personnel exception, “a domestic service employee must not only perform services requiring the training of a registered or practical nurse, but must in fact have obtained training comparable in scope and duration to that of a registered or practical nurse.”61 only one case involving the companionship exemption made its way to the supreme court, long island care at home, ltd. v. coke.62 at issue was whether the dol’s regulation permitting third-party employers to avail themselves of the companionship exemption was valid.63 coke was a caregiver that regularly worked seventy hours per week,64 and she sought minimum wages and overtime pay from her employer, a home care agency, and its owner.65 coke argued that third-party employers should not benefit from the companionship exemption for three reasons. first, coke claimed that domestic service employment is an activity limited to those employed by the recipients of care. in support of her argument, coke argued that the social security act defines “domestic service employment” as activity conducted in the home of the employer.66 she further argued that domestic service workers used to be covered through enterprise coverage.67 the court deemed this 58 id. at 1309. 59 id. at 1310. 60 id. 61 id. (emphasis omitted). 62 long island care at home, ltd. v. coke, 551 u.s. 158 (2007). 63 id. at 162. 64 elizabeth riordan, where the heart is: amending the fair labor standards act to provide wage and overtime pay protection to agencyemployed home health aides, 85 st. john's l. rev. 837 (2011). 65 long island care at home, ltd., 551 u.s. at 164. 66 id. at 166. 67 id. at 165. 2016 443 help that hurts: how dol’s home care rule harms people with disabilities and caregivers argument unconvincing, noting that flsa “expressly instructs the agency to work out the details of those broad definitions [of ‘domestic service employment’ and ‘companionship services’]. . . . [w]hether to include workers paid by third parties within the scope of the definitions is one of those details.”68 next, coke argued that the plain language of the thirdparty regulation conflicts with the definition of “domestic service employment,” in that the latter requires the worker to be in the home of the person by whom he or she is employed.69 the court agreed that conflict exists, but determined that the third-party regulation governs.70 from a practical perspective, the court did not believe it made sense for the exemption to hinge on whether the payor resided in the same household as the individual receiving care. if the conflict was resolved as coke desired, then family members would not be able to avail themselves of the exemption if they lived in a different household than the individual receiving care. such was not the intent of congress.71 from a legal perspective, “normally the specific governs the general,” meaning that the third-party regulation, the sole purpose of which is to address the issue of third-party payors, should trump the more general definitional regulation.72 finally, coke took issue with the way the regulation was promulgated.73 she argued that the third-party regulation was interpretive, and interpretive regulations cannot be used to bindingly fill a statutory gap, but are more appropriately deemed persuasive materials.74 however, the court found this reasoning unconvincing.75 the dol used formal notice and comment procedures, suggesting the regulation was meant to be as binding as any other.76 moreover, the regulation was within the scope of the dol's authority and 68 id. at 167. 69 id. at 168. 70 id. at 169. 71 id. at 170. 72 id. 73 id. at 171-72. 74 id. at 172. 75 id. 76 id. at 173. 444 indiana health law review vol 13:2 was reasonable.77 coke argued that promulgation procedures were defective because notice and explanation of the regulation were inadequate.78 the court found that dol complied with its legal promulgation duties.79 therefore, the new law of the land permitted third parties to avail themselves of the companionship exemption. c. administrative challenges in 1993, the first attempt to limit use of the companionship exemption was attempted by the clinton administration.80 specifically, the dol published its intent to forbid third-party employers from using the companionship and live-in exemption, except for those circumstances in which the employer had a joint employment relationship with the recipient of care.81 the rule was proposed as a mere clarification, based on the dol's belief that the issue “may be susceptible of misinterpretation.”82 in 1995, the dol reopened the comment period for those rules proposed in 1993.83 although only seven comments were received in response to the 1993 notice of proposed rulemaking, they caused the dol to consider the potential effect the proposed rule would have on state and local governments responsible for funding companionship services.84 thus, the dol specifically sought comments on permitting government entities, along with recipients of care and their family members, to avail themselves of the companionship exemption.85 77 id. 78 id. at 174. 79 id. at 175. 80 application of the fair labor standards act to domestic service, 58 fed. reg. 69,310 (dec. 30, 1993) (to be codified at 29 c.f.r. pt. 552). 81 id. 82 id. at 69,311. 83 application of the fair labor standards act to domestic service, 60 fed. reg. 46,797 (sept. 8, 1995) (to be codified at 29 c.f.r. pt. 552). 84 id. at 46,797-98. 85 id. at 46,798. 2016 445 help that hurts: how dol’s home care rule harms people with disabilities and caregivers a second, more comprehensive effort to amend the companionship exemption occurred in 2001.86 the notice of proposed rulemaking stated that the home care industry had experienced “significant changes” since 1975, such that home care workers were “performing types of duties and working in situations that were not envisioned when the companionship services regulations were promulgated.”87 finding that the exemption no longer matched congress’s intent, the dol again proposed excluding third-party employers from utilizing the companionship and live-in exemption.88 the dol also proposed redefining “companionship services” and amending qualification criteria for “trained personnel.”89 the bush administration withdrew the proposed rule in 2002.90 the dol under president clinton stated that the proposed rule would not have a significant economic impact.91 however, this assertion was “seriously called into question” by commenters, including the small business administration and the department of health and human services.92 the companionship exemption remained untouched until 2011, when the obama administration decided to revive the clinton proposals and introduce further amendments. as in 1993, the dol cited changes in the home care industry, including “growing demand for long-term in-home care,” the “rising cost of traditional institutional care,” the “availability of funding assistance for in-home care under medicare and medicaid,” and a “significant increase in our aging 86 application of the fair labor standards act to domestic service, 66 fed. reg. 5481 (jan. 19, 2001) (to be codified at 29 c.f.r. pt. 552). 87 id. at 5482. 88 id. at 5485. 89 id. at 5483-84. 90 application of the fair labor standards act to domestic service, 67 fed. reg. 16,668 (apr. 8, 2002) (to be codified at 29 c.f.r. pt. 552). 91 application of the fair labor standards act to domestic service, 58 fed. reg. 69,310, 69,311 (dec. 30, 1993) (to be codified at 29 c.f.r. pt. 552). 92 application of the fair labor standards act to domestic service, 67 fed. reg. at 16,668. 446 indiana health law review vol 13:2 population.”93 according to the dol, these factors contribute to a different workforce then that intended by congress.94 today’s companions are often employed by third-party agencies rather than directly by the recipient of care,95 and many of the companions rely on the job as their primary source of income.96 the dol asserted that narrowing the companionship exemption would more accurately reflect congressional intent.97 first, the dol proposed broadening section 552.6, defining “companionship services,” into four paragraphs.98 paragraph (a) defines “companionship services” as “the provision of fellowship and protection for a person who, because of advanced age or physical or mental infirmity, is unable to care for themselves,” and goes on to define “fellowship” and “protection.”99 paragraph (b) provides that “companionship” includes the provision of care, so long as that care is incidental in nature.100 incidental services constituting companionship, per the dol, include using public transportation, going to appointments, and attending social events.101 other services may be deemed incidental only after a fact-intensive inquiry. for example, the dol expects that recipients of care can schedule their bathing routines to be outside of a companion’s hours.102 therefore, assisting a client with a bath or shower is outside the scope of companionship. however, if there is “an imminent need” for “cleansing,” the dol consider it “a reasonable but limited exception[]” and permit assistance from a companion.103 93 application of the fair labor standards act to domestic service, 76 fed. reg. 81,190, 81,190-91 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). 94 id. at 81,192. 95 id. at 81,193. 96 id. at 81,197. 97 id. at 81,192. 98 id. 99 id. at 81,193. 100 id. at 81,192. 101 id. at 81,193. 102 id. 103 id. 2016 447 help that hurts: how dol’s home care rule harms people with disabilities and caregivers paragraph (c) further limits the scope of incidental duties, excluding “[g]eneral household work . . . such as vacuuming, washing windows, and dusting” from the definition of companionship.104 because congress offered flsa protection to domestic service workers such as maids, the dol believes tasks traditionally performed by these workers should not be included within a flsa coverage exemption.105 as such, companions can no longer assist their clients with light housework. paragraph (d) eliminates from companionship services “medical care that is typically provided by personnel with specialized training.”106 the list of excluded activities is broad. some tasks, such as blood sugar screening and the provision of physical therapy, clearly require training or direction. yet other activities, such as “routine foot, skin, and back care”107 appear to be just that–routine activities that require nothing more than common sense and an able body. nevertheless, companions may not provide such assistance. further, the dol eradicated the third-party companionship exemption for all parties, except “for the individual, family, or household” receiving care.108 this means that states and other government entities involved in funding homecare may be on the hook to pay minimum wage and overtime. it is also important to note that individuals and families receiving care are not completely isolated from the rule’s reach. recall that the scope of “companionship services” was limited.109 thus, if a companion fails to qualify for the exemption and the individual or family receiving care can be considered a sole or joint employer, the individual or family will be required to pay minimum wage and overtime, regardless of any previously negotiated contract. if a recipient of care needs help going to the bathroom an extra time one day, this extra care could potentially trigger the 20 percent threshold and require that individual to pay 104 id. at 81,195. 105 id. 106 id. 107 id. 108 id. at 81,198. 109 see supra section ic. 448 indiana health law review vol 13:2 minimum wage and overtime. if a recipient of care eats with a feeding tube, that individual will automatically be liable for minimum wage and overtime, as assisting him triggers the medically related services provision. finally, the dol withdrew permission for live-in aides and employers to negotiate an employment contract in lieu of keeping a log of hours worked.110 in fact, the proposed regulation puts complete responsibility on the employer “for making, keeping, and preserving records of hours worked and ensuring the accuracy” thereof.111 d. home care association challenge despite the dol “anticipat[ing] that the proposed rule will have relatively little effect on the provision of companionship services,”112 concerns were immediately raised by home care agencies and recipients of home care services. the home care association of america, the international franchise association, and national association for home care and hospice quickly brought an action under the administrative procedures act, arguing that the proposed rules constituted an arbitrary and capricious endeavor, clearly contrary to congressional intent and delegated authority.113 they requested an injunction, in order to continue utilizing the third-party provisions of the companionship exemption.114 the d.c. circuit court held that the regulations conflict with both the legislative history and plain language of the flsa.115 in step i of the chevron analysis, the court must address whether congress directly spoke to the question at issue.116 if the answer is “no”, chevron step ii requires the 110 application of the fair labor standards act to domestic service, 76 fed. reg. at 81,198. 111 id. at 81,199. 112 id. at 81,223. 113 complaint for declaratory and injunctive relief, home care ass’n of am. v. weil, 76 f. supp. 3d 138 (d.c. cir. 2014) (no. 1:14-cv-00967). 114 id. 115 home care ass'n of am. v. weil, 76 f. supp. 3d 138, 147-48 (d.d.c. 2014), rev'd sub nom., 799 f.3d 1084 (d.c. cir. 2015). 116 id. at 143. 2016 449 help that hurts: how dol’s home care rule harms people with disabilities and caregivers court to determine whether congress delegated authority to the executive agency to implement statute or fill a gap.117 judge leon found that “congress surely did not delegate to the department of labor here the authority to issue a regulation that transforms defining statutory terms into drawing policy lines based on who cut the check rather than what work is being performed.”118 although congress did leave some gaps to be filled by the dol, including the definition of companionship services, once the “gaps were filled. . . , the statutory loop was closed.”119 ultimately, by implementing regulations that congress declined to implement by statute, the dol engaged in “yet another thinly-veiled effort to do through regulation what could not be done through legislation. such conduct bespeaks an arrogance to not only disregard congress’s intent, but seize unprecedented authority to impose overtime and minimum wage obligations in defiance of the plain language of section 213.”120 once leon vacated the third-party employment regulation, the trade associations gained standing. the associations petitioned for emergency injunctive relief to prevent the enforcement of the proposed regulations. the petition resulted in a memorandum decision from the dc circuit court, again written by judge leon. in this second decision, judge leon found that while congress did explicitly delegate to the dol the power to define “companionship services,” that delegation did “not grant it a blank check to do so in a way that contradicts the act itself.”121 more specifically, the flsa references companionship services in a way that makes clear such services are to be provided to individuals that cannot care for themselves.122 yet, the dol's proposed regulations remove that essential care from the definition.123 congress revisited 117 id. at 143-44. 118 id. at 144. 119 id. at 145. 120 id. at 147-48. 121 home care ass’n. of am. v. weil, 78 f. supp. 3d 123, 128 (d.d.c.), rev'd sub nom., 799 f.3d 1084 (d.c. cir. 2015). 122 id. 123 id. 450 indiana health law review vol 13:2 the companionship provisions of the flsa on numerous occasions since 1974, but never amended those provisions.124 therefore, the dol, in offering regulations on a topic in which congress has already spoken and made its intent clear, acted outside the scope of its authority.125 the inquiry stops at step i of the chevron analysis.126 the dol appealed, arguing that the supreme court's decision in coke precludes the analysis ending at step i.127 the u.s. court of appeals agreed.128 judge srinivasan opined that coke placed within the dol a “broad grant of authority” to decide whether companions employed by third parties fall within the scope of the companionship exemption.129 while the d.c. circuit court was incorrect to look to unpassed legislation as evidence of congressional intent, the supreme court already determined that, when it comes to the inclusion of third-party employers, “the full range of potential outcomes lay within the agency’s discretion.”130 home care association asserted that the dol's interpretation was arbitrary, but the court found that the proposed regulations were “entirely reasonable.”131 particularly, the dol was attempting to bring flsa protections to those employees “whose vocation is domestic service.”132 moreover, the court determined that the heightened standard home care association wanted imposed with regard to a justification for reversing forty years of contrary interpretation was inappropriate.133 the dol provided “a reasoned explanation” for limiting the exemption, which meets its legal burden.134 124 id. at 130. 125 id. 126 id. at 128. 127 corrected reply brief for appellants, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-5018), 2015 wl 1602118. 128 home care ass'n of am. v. weil, 799 f.3d 1084, 1087 (d.c. cir. 2015). 129 id. at 1092 (internal quotation marks omitted). 130 id. (internal citation omitted). 131 id. at 1093. 132 id. at 1094 (internal citation omitted) (emphasis original). 133 id. 134 id. at 1094-95. 2016 451 help that hurts: how dol’s home care rule harms people with disabilities and caregivers ultimately, the court reversed and granted summary judgment to the dol.135 on september 24, 2015, the trade associations petitioned supreme court chief justice john roberts to stay the rule, pending disposition of a petition for certiorari.136 justice roberts denied the petition on october 6, 2015. iii. effects for recipients of care the 2010 census revealed that 56.7 million, or about one in five, people have a disability.137 more than half of them consider their disability to be severe.138 almost 10 million noninstitutionalized people indicated the need for assistance with one or more activities of daily living.139 these activities include tasks like dressing, toileting, and preparing meals. thus, there is a great need for the services of home care workers. indeed, given the reliance of people with disabilities on their caregivers, the home care rule has the potential to negatively affect them. a. delivery of services in order to understand how the home care rule will affect the quality and amount of care received by people with disabilities, it is necessary to examine the methods through which these services are delivered. home care is funded through a variety of sources, including private pay by individuals and families and via government insurance programs. approximately three-quarters of home care expenditures are paid by medicare and medicaid.140 135 id. at 1097. 136 application for a stay of mandate pending the timely disposition of a petition for a writ of certiorari, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-a-326). 137 nearly 1 in 5 people have a disability in the u.s., u.s. census bureau (july 25, 2012), https://www.census.gov/newsroom/releases/ archives/miscellaneous/cb12-134.html [http://perma.cc/fj79-trjt]. 138 id. 139 id. 140 application of the fair labor standards act to domestic service, 76 fed. reg. 81,190, 81,223 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). medicaid funds the bulk of home care, paying for approximately 452 indiana health law review vol 13:2 medicaid is not required to cover home health care,141 though most states have chosen to fund home care through a variety of methods.142 traditionally, medicaid beneficiaries receiving personal care in community settings have received services from a third-party home health agency that manages their care.143 under this system, the agency is responsible for hiring and firing caregivers, seeking payment, and addressing any problems that arise.144 the state provides payment to the agency for this service. in self-directed care programs, also known as consumerdirected care, the recipient of care is responsible for taking on many of the tasks historically performed by home care agencies.145 payment of these caregivers depends on the type of system the state has adopted.146 sometimes, the recipient of care is responsible for paying their caregiver and completing taxes.147 other times, the state will contract with a fiscal intermediary that handles payroll and taxes.148 regardless of the program’s particulars, consumer-directed care is growing. since 2001, almost all states have implemented at least one consumer-directed care program.149 41% of the yearly home care expenditures. medicare pays approximately 35% of these expenditures. 141 medicaid long-term care services, u.s. dep’t health & hum. resources, http://longtermcare.gov/medicare-medicaid-more/medicaid /medicaid-long-term-care-services/ [http://perma.cc/64jj-fd9n] (last visited apr. 11, 2016). however, medicaid is required to pay for care in institutional settings. 142 id. 143 robert newcomer et al., consumer-directed personal care: comparing aged and non-aged adult recipient health-related outcomes among those with paid family versus non-relative providers, 30 home health care servs. q. 178, 179 (2011). 144 id. 145 teresa scherzer et al., financial management services in consumer-directed programs, 26 home health care servs. q. 29, 30 (2007). 146 id. 147 id. 148 id. at 33. 149 id. at 30. http://dx.doi.org/10.1080/01621424.2011.622245 http://dx.doi.org/10.1300/j027v26n01_03 2016 453 help that hurts: how dol’s home care rule harms people with disabilities and caregivers b. state implementation many states are unprepared to comply with the new home care rule. fiscal year budgets are already in place for 2016, and 2017 budgets are already well-developed in many states.150 this means that even if states were willing to bolster already-stretched medicaid budgets, in order to cover the additional costs of minimum wage and overtime, it is too late. it is unlikely that agencies will be reimbursed beyond current medicaid reimbursement rates for the foreseeable future. this means home health agencies will be required to eat the cost of the rule’s new burdens or cease medicaid participation. the situation is even more complex for states offering medicaid beneficiaries the opportunity to participate in consumer-directed services. states will be required to conduct an analysis to determine whether managed care organizations and fiscal intermediaries participating in these programs constitute a joint employment relationship. the dol issued guidance on joint employment relationships, indicating that an economic realities analysis must be conducted.151 elements of this analysis include “whether the potential employer has the power to hire and fire the employees, supervise and control the employees’ work, determine the rate of payment, maintain employment records, and control where the work is performed.”152 150 bazelon center for mental health law et al., action steps for consumers and advocates regarding the dol home care rule: how to prevent service cuts and protect consumer-directed programs 4-5 (2015), available at http://www.bazelon.org/ linkclick.aspx?fileticket=u0rrebo3ady%3d&tabid=40 [https:// perma.cc/jap3-9fxq]. 151 wage and hour division, fact sheet #79e: joint employment in domestic service employment under the fair labor standards act (flsa), u.s. dept. of labor, (last updated june 2014) https:// www.dol.gov/whd/regs/compliance/whdfs79e.htm [https://perma.cc/96zt8qkr]. 152 cindy mann, cmcs informational bulletin: self-direction program options for medicaid payments in the implementation of the fair labor standards act regulation changes 2 (2014), available at http://www.medicaid.gov/federal-policy-guidance/ downloads/cib-07-03-2014.pdf. 454 indiana health law review vol 13:2 in the event that the relationship constitutes joint employment, a state must be vigilant not only of how many hours an employee works for each medicaid beneficiary, but also whether the cumulative hours of each medicaid beneficiary served by the employee will trigger minimum wage and overtime protection. even if an employee provides caregiving services for less than 40 hours per week to multiple medicaid beneficiaries, states must also calculate travel time between beneficiaries’ homes and include it in the worker’s hours.153 given the parameters of existing budgets, states are trying to develop creative solutions for implementing the rule. unfortunately, these solutions may come at the expense of the recipients of care, as discussed in the sections below. the department of health and human services (dhhs) has released documents “strongly urg[ing] states to ensure that overtime or travel costs beyond an individual's control not be deducted from the individual’s self-directed budget.”154 that is, a recipient of care should not be forced to forgo services while a caregiver is driving to or from their home. the dhhs and the department of justice also released a joint “dear colleague letter” reminding states of their obligation under title ii of the americans with disabilities act (ada) to provide those services that permit individual with disabilities to live in the least restrictive environment.155 in particular, the agencies recognized that states are planning to put a 40-hour cap on the amount of services that can be provided by any given worker. they warned that “implementation of across-the-board caps risks violating the ada if the caps do not account for the needs of individuals with disabilities and consequently places them at serious risk of institutionalization or segregation.”156 153 see application of the fair labor standards act to domestic service, 76 fed. reg. 81,190, 81,219 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). 154 mann, supra note 153, at 3. 155 vanita gupta & jocelyn samuels, olmstead dear colleague letter on flsa home care rule, dep’t health & hum. servs. (dec. 15, 2014), http://www.hhs.gov/sites/default/files/2014hhsdojdearcolleagueletter.pdf [http://perma.cc/mc2p-wg69]. 156 id. at 3. 2016 455 help that hurts: how dol’s home care rule harms people with disabilities and caregivers nevertheless, states will be faced with difficult choices. unfortunately, institutionalization, as well as increased safety risks, appear to be very real natural consequences of the rule’s implementation at the state level.157 c. harms to recipients of care from the beginning, the dol has failed to recognize the magnitude of the changes it has mandated. the notice of proposed rulemaking anticipated “that the proposed rule will have relatively little effect on the provision of companionship services.”158 yet, it admits that there is “almost no data . . . that can directly be used to model the market for companionship services.”159 additionally, “[d]ue to the sometimes informal nature of the consumer-directed employment arrangements, there are no data on the total number of customers under this model, and there is limited information on the total number of providers.”160 instead of conducting a thorough market analysis, the dol concluded that, because 14 states currently provide some type of minimum wage or overtime protection to companions, “objections raised in the past regarding the feasibility and expense of prohibiting third parties from claiming the companionship and live-in worker exemptions” are negated.161 this fact is misleading because not all fourteen states provide the complete protection mandated under the new rule.162 it also ignores the fact that those 157 this is especially ironic considering that the expenses of olmstead litigation, and even institutionalized care itself, are greater financial burdens for states than the provision of a good homeand communitybased care system. see charlene harrington et al., do medicaid home and community based service waivers save money?, 30 home health care servs. q. 198, 210 (2011). 158 application of the fair labor standards act to domestic service, 76 fed. reg. at 81,223. 159 id. 160 id. at 81,208. 161 id. at 81,197. these states are: colorado, hawaii, illinois, maryland, massachusetts, michigan, minnesota, montana, nevada, new jersey, new york, pennsylvania, washington, and wisconsin. 162 id. at 81,204-06. http://dx.doi.org/10.1080/01621424.2011.622249 456 indiana health law review vol 13:2 states chose to implement the protections, and consequently had the opportunity prepare for implementation.163 the dol, while perhaps not aware of the severity of changes, was aware that home care agencies will need to make significant changes in order to comply with the new regulation. it offered three operational choices to these agencies: first, the agency might manage existing staff to reduce overtime hours while managing the same caseload and staffing levels. . . . second, as suggested in the city of new york's amicus brief, agencies might choose not to allow staff to exceed 40 hours per week. . . . the third scenario comprises a mix of the first and second approach. neither of those approaches is costless to agencies, therefore, agencies will weigh the costs of hiring additional workers with the cost of paying overtime to existing workers to determine the optimal mix of overtime a new hires approximate to their circumstances.164 easier said than done. in an amici brief, multiple states argued that “the operational viability” of the medicaid program has been threatened, “both in letter and spirit.”165 how have states reacted thus far? by the time adapt and the national council on independent living submitted their joint brief, arkansas had proposed placing a forty-hour per week cap on 163 dol did not release fact sheet #79e, regarding the homecare rule’s effect on states, until june 2014. see u.s. dep’t of labor, fact sheet #79e: joint employment in domestic service employment under the fair labor standards act (flsa) (2014), available at http://www.dol.gov/whd/regs/compliance/whdfs79e.pdf. 164 application of the fair labor standards act to domestic service, 76 fed. reg. at 81,218. 165 brief of the states of kansas, arizona, georgia, michigan, nevada, north dakota, tennessee, texas and wisconsin in support of affirming the district court at 2, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-5018), 2015 wl 1534373, at *2. 2016 457 help that hurts: how dol’s home care rule harms people with disabilities and caregivers companionship hours.166 virginia proposed a fifty-six hour cap and requiring providers of companionship services to have a single employer.167 illinois, massachusetts, new mexico, and new york–a few of the states the dol looks to as proof that the home care rule will be effective–openly acknowledge capping hours.168 individuals receiving care will not simply stop needing to go to the bathroom after receiving 40 hours of care. rather– and assuming they are provided the extra assistance–these individuals will have to invite more strangers into their homes. as disability rights activists maintain: “[p]ersonal autonomy and bodily integrity are fundamental human rights. our courts have upheld these rights in a variety of situations where others have sought to regulate an individual’s body.”169 likewise, laws against assault and battery “protect individuals from experiencing unwanted touching from another person. however, under the new rule, disabled people will be forced to allow unwanted touching by new attendants if they want to live in the community.”170 legal scholars brush over this argument. molly biklen writes, “[t]he commodification of caregiving and the growth of the home healthcare industry suggest that there is no longer a core of intimate personal services to be protected by an exemption.”171 tell that to the elderly woman who needs help cleaning up after she could not quite make it to the restroom on time. tell the transgendered man who needs assistance changing his clothes that it is no big deal who sees his surgical scars.172 try keeping a straight face, knowing 166 corrected brief for adapt and the national council on independent living as amici curiae supporting appellees at 10, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-5018), 2015 wl 1534374, at *10. 167 id. at 11. 168 id. 169 id. at 22. 170 id. at 25. 171 molly biklen, healthcare in the home: reexamining the companionship services exemption to the fair labor standards act, 35 colum. hum. rts. l. rev. 113, 150 (2003). 172 see corrected brief for adapt and the national council on independent living as amici curiae supporting appellees, supra note 162, at 23-24. 458 indiana health law review vol 13:2 that individuals with disabilities have a dramatically higher rate of suffering violent crime than non-disabled individuals.173 lack of respecting one’s preference is a particularly salient issue for participants in consumer-directed care programs. people choose to participate in such programs for the very purpose of controlling their care. as new york’s consumer directed personal assistance program (cdpap) attempted to persuade in its amicus brief: the cdpap is the gem of the medicaid program. it is quintessentially american. it is about liberty. in the cdpap, the individual, not the agency, decides when to get up, when to take a bath, when to get dressed, and when to go to bed. the individual decides who to let into his or her own home. the individual decides how services are delivered. the individual decides who can touch his or her body. the individual is in charge of his or her own life.174 if a fiscal intermediary is forced to cap caregiver hours under the new rule, participants will lose vital autonomy. in certain situations, individuals may lose caregivers altogether. consider arkansas again, which has considered forbidding caregivers from serving more than one client with a disability.175 these caregivers, in order to make a living, are going to seek out those clients that need a number of 173 violent crime rate in 2013 against persons with disabilities was more than double the age-adjusted rate for persons without disabilities, bureau of justice statistics (may 21, 2015, 10:00 am), http://ojp.gov/newsroom/pressreleases/2015/ojpapr05212015.pdf [http://perma.cc/7k5u-pfet]. 174 amicus curiae brief of the consumer directed personal assistance association of new york state submitted in support of the plaintiffs/appellees at 10, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-5018), 2015 wl 1544793, at *10. 175 corrected brief for adapt and the national council on independent living as amici curiae supporting appellees, supra note 162, at 18. 2016 459 help that hurts: how dol’s home care rule harms people with disabilities and caregivers hours of service as close to the maximum as possible.176 yet many people with disabilities only need–or have only been approved for–as few as two or three hours of service per day. services received during these hours are often crucial, entailing, for example, getting out of bed in the morning or getting transported to work. but, unless these individuals find caregivers willing to earn minimum wage for fifteen hours per week, they may be stuck in bed.177 the dol answered advocates’ concerns by advancing the position that continuity of care is already diminished because “low wages, poor or nonexistent benefits, and erratic and unpredictable hours” result in high caregiver turnover.178 it claims that, in some locations, the turnover rate is 100%.179 these extreme statistics are questionable on their face. disability advocacy groups furthermore recognize that, in gathering turnover rate data, the dol combined post-acute, long-term, and consumer-directed care statistics.180 this amalgam is improper because post-acute care is, by its nature, not designed to be sustained.181 regardless of whether continuity of care is already poor, the home care rule threatens to exacerbate the problem. kansas told the court that it has a shortage of home care workers available in its rural communities.182 other states lack a sufficient number of caregivers to assist recipients of care for whom spoken english is not the primary language.183 individuals requiring care in these situations are already at 176 presumably, this maximum will be 40 hours per week. 177 or, of course, get forced into an institution. 178 application of the fair labor standards act to domestic service, 76 fed. reg. 81,190, 81,229 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). 179 id. 180 corrected brief for adapt and the national council on independent living as amici curiae supporting appellees, supra note 162, at 17. 181 id. 182 brief for the states of kansas, arizona, georgia, michigan, nevada, north dakota, tennessee, texas and wisconsin at 4, home care association of am. v. weil, 799 f.3d 1084 23, (d.c. cir. 2015) (no. 155018). 183 corrected brief for adapt and the national council on independent living as amici curiae supporting appellees, supra note 162, at 20. 460 indiana health law review vol 13:2 extreme risk of being institutionalized. limiting the pool of available care by placing a limit on the number of hours that each caregiver may work is dangerous for people who need the care and is also against the interests of the caregivers themselves. iv. consequences for home care workers the home care rule was promulgated for the benefit of those who have devoted their career to caregiving. the dol cited “significant changes in the home health care industry over the last 35 years” as justification for the amendments.184 advocates for the inclusion of domestic service workers into flsa’s protective fold argue that the work is “at the very least, thankless,” and, at best, “despised and low class.”185 by offering caregivers flsa protection, by recognizing their job duties as valuable, and by treating them like other professionals, advocates argue, caregiver status is improved. but is this actually the case? both the dol and labor advocates fail to recognize the role of the caregiver as unique. caregivers are valued by those for whom they care. indeed, without assistance from a caregiver, many individuals with disabilities would not be able to get out of bed in the morning. that an individual with a disability is so dependent upon a caregiver to provide necessary assistance with intimate activities of daily living creates a relationship beyond the typical employer-employee exchange. caregivers do more than assist their employers routine job duties; instead, they assist them in living life. it is crucial that any regulations affecting home care take this dynamic into account. moreover, although the home care rule may sound good to some labor advocates in theory, the regulations do not guarantee that caregivers will actually receive higher wages. as discussed in part iii, the dol actually provides employers with workarounds to avoid paying caregivers 184 application of the fair labor standards act to domestic service, 76 fed. reg. at 81,190. 185 lisa diaz-ordaz, real work: domestic workers’ exclusion from the protections of labor laws, 19 buff. j. gender l. & soc. pol’y 10708 (2001). 2016 461 help that hurts: how dol’s home care rule harms people with disabilities and caregivers increased wages.186 lessons from states currently attempting to implement the home care rule demonstrate that caregivers may actually have decreased wages and autonomy, as explored in section b. a. home care worker representation it is not evident why the obama administration believed amending the regulations was appropriate. although it cited a growing demand for care, as well as increased government funding, the dol failed to make a case that the actual nature of home care has changed. as congress members opposing the changes noted, [w]e may have made many technological advances . . . but no one has yet found a viable everyday substitute for eating, dressing, or bathing. an elderly or infirm person incapable of caring for himself or herself in 1974 needed the same type of assistance that . . . person needs today.187 instead, the motivation for the rule appears political; supporters have certainly cast it in such terms. secretary perez stated: “the pie is growing; american workers helped bake it, but most of them aren’t getting a bigger slice.”188 scholars refer to the companionship exemption as 186 application of the fair labor standards act to domestic service, 76 fed. reg. at 81,218. 187 brief for amici curiae members of congress at 20, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-5018). those represented by the brief include senators mitch mcconnell, pat roberts, lamar alexander, roy blunt, john boozman, mike enzi, johnny isakson, and marco rubio, as well as representatives tim walberg and lynn jenkins. 188 thomas e. perez, the fair labor standards act at seventy-seven: still “far-reaching, far-sighted”, 30 aba j. lab. & emp. l. 299, 300 (2015). 462 indiana health law review vol 13:2 “shortchanging workers,”189 promoting “a legal fiction,”190 or a codification of “the legacy of slavery.”191 it is true that many home care workers fit within at least one category typically viewed as marginalized. per dol statistics, the average caregiver is a female in her mid-40s.192 there is approximately a 40% chance that she is africanamerican or hispanic, and, in some regions, a fair chance that she is foreign-born.193 these statistics also mean there is a great chance that many of these caregivers voted for obama.194 indeed, the service employees international union (seiu) was a top contributor to the obama campaign, raising more money for democratic candidates in 2012 then obama's biggest political action committee.195 189 julia lippitt, protecting the protectors: a call for fair working conditions for home health care workers, 19 elder l.j. 219, 236 (2011). 190 biklen, supra note 167, at 146. 191 brief of women’s rights, civil rights, and human rights organizations and scholars as amici curiae in support of defendantsappellants seeking reversal at 5, home care ass’n of am. v. weil, 799 f.3d 1084 (d.c. cir. 2015) (no. 15-5018). those represented by the brief include the american civil liberties union, the asian american legal defense and education fund, eileen boris, jennifer klein, students in the health and human rights clinic at indiana university mckinney school of law, latina/latino critical legal theory, inc., national law center on homelessness and poverty, national center for law and economic justice, national council of la raza, national hispanic leadership agenda, national women's law center, northwest arkansas workers’ justice center, santa clara university school of law international human rights clinic, the u.s. human rights network, frank askin, karl klare, william p. quigley, and deborah m. weissman. 192 application of the fair labor standards act to domestic service, 76 fed. reg. 81,190, 81,211 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). 193 id. at 81,212. 194 united states elections: how groups voted in 2012, roper center., http://ropercenter.cornell.edu/polls/us-elections/how-groupsvoted/how-groups-voted-2012/ [http://perma.cc/9tqq-p5w9] (last visited apr. 11, 2016). 195 melanie trottman & brody mullins, union is top spender for democrats, wall st. j., http://www.wsj.com/articles/ sb10001424052970204707104578091030386721670 [http://perma.cc/ 2flz-j9b5] (last updated nov. 1, 2012). 2016 463 help that hurts: how dol’s home care rule harms people with disabilities and caregivers home care workers began organizing in the mid-1980s.196 the first states to organize were oregon, washington, illinois, and massachusetts.197 maryland, missouri, connecticut, vermont, and minnesota were next.198 through collective bargaining, home care workers in these states were able to negotiate some combination of healthcare, training, paid time off, grievance procedures, transportation, and benefits.199 for example, in some california counties, a home care worker receives healthcare, training, free use of public transportation, and the opportunity to grieve about adverse employment determinations.200 however, these benefits come with a cost, sometimes to the recipient of care. the demands of organized labor are often at odds with the consumer-directed care model. not only does an individual receiving care need to work with strangers in completing activities of daily living, but, in organized states, they are forced to invite yet another strange party into their private sphere. each additional group that receives a voice in the care delivery discussion diminishes autonomy available to the recipient of care. although the seiu may believe caregivers should have the right to appeal terminations, that means individuals receiving care may be stuck working with a caregiver that was terminated for an egregious error. perhaps an omission caused the caregiver to injure her client. surely, the injured party should not be forced to maintain such a dangerous situation. granted, a consumer-directed care employer may terminate a caregiver for reasons unrelated to poor conduct, and possibly even for reasons over which the caregiver has no fault. but, recall that the recipient of care needs to feel comfortable with the individual assisting him or her with the most personal of tasks. 196 seiu local 503, overview of homecare collective bargaining, seiu local 503.org (dec. 13, 2013), http://www.seiu503.org/ 2013/12/overview-of-homecare-collective-bargaining/ [http://perma.cc/ gm9w-nawx]. 197 id. 198 id. 199 id. 200 id. 464 indiana health law review vol 13:2 similarly, labor scholar peggie smith complains that the occupational safety and health act does not adequately protect employees engaged in the provision of consumerdirected care.201 she argues that home care workers have “no protection from various hazards including dangerous household objects, exposure to blood or other infectious material, and injuries occasioned by lifting and moving clients.”202 yet going into homes and touching disabled, elderly, and potentially ailing bodies are essential functions of home care work. smith appears to prefer that homes be treated as office buildings, and that clients subscribe to a strict union-approved protocol. whether or not a hoyer lift is a pain in the butt–or literally causes pain–for recipients of care is inconsequential, as long as protocols are in place. union activity also has costs for employees. part of this cost comes from the collection of dues. until the supreme court issued its 2014 decision in harris v. quinn, unions were collecting fair share dues from caregivers that had no desire to join.203 in less than 18 months, approximately 30,000 home care workers ended their membership in seiu healthcare illinois, indiana, missouri, and kansas.204 this mass exodus from the union’s rolls suggests that perhaps seiu was not speaking for most home care workers. indeed, union contracts have cost some home care workers wage-earning hours. in early 2015, seiu negotiated with the state of minnesota to set a $10.75 minimum wage for personal care attendants.205 minnesota resident scott price explained that he would have to cut back hours of care 201 peggie r. smith, home sweet home? workplace casualties of consumer-directed home care for the elderly, 21 notre dame j.l. ethics & pub. pol’y 537, 549-50 (2007). 202 id. at 550. 203 harris v. quinn, 134 s. ct. 2618 (2014). 204 sean higgins, caregivers leave midwest union in droves one year after harris v. quinn, wash. examiner (nov. 1, 2015, 1:01 am), http://www.washingtonexaminer.com/caregivers-leave-midwest-unionin-droves-one-year-after-harris-v.-quinn/article/2575406 [http:// perma.cc/6tgy-2v77]. 205 j. patrick coolican, seiu contract kicks in for 27,000 home care aides in minnesota, star trib. (june 30, 2015, 11:06 pm), http://www.startribune.com/seiu-contract-kicks-in-for-27-000-homecare-aides-in-state/311086561/ [http://perma.cc/xp24-g4sy]. 2016 465 help that hurts: how dol’s home care rule harms people with disabilities and caregivers received by his daughter, a 23-year-old with cerebral palsy, because he could not afford to pay the higher minimum wage for those hours she was asleep.206 as he explained, “the burden falls back on the family in terms of caring for a child with a disability[.]”207 the prices are not alone; few families are in a position to afford the $94,170 price tag that now comes with a year of 24-hour care in minnesota. the situation in minnesota is illuminating for two reasons. first, as mr. price states, despite claims about increased professionalization of the caregiving workforce, much of the responsibility for caregiving falls to family members.208 some of this care is unpaid. however, consumer-directed care provides a unique opportunity for family members to receive payment for caring for a loved one with a disability. the dol, for example, notes that california “has a high percentage of caregivers who are paid family members.”209 in michigan, approximately half of the independent providers are related to recipients of care.210 that many caregivers are related to their employer diminishes the validity of accusations that these workers are treated deplorably. it also means that many of these workers feel intruded upon by increased regulatory and professional oversight, just as their employers do. they do not want union members to come to their homes and conduct inspections.211 nor are such workers interested in being trained regarding the care of a loved one.212 additionally, many of these 206 id. 207 id. 208 id. 209 application of the fair labor standards act to domestic service, 76 fed. reg. 81,190, 81,212 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). 210 pamela doty et al., consumer choice and the frontline worker, 18 generations 65 (1994), available at http://aspe.hhs.gov/sites/ default/files/pdf/73936/frntlnwk.pdf [http://perma.cc/l65e-cll4]. 211 sean higgins, big labor trickery on display in effort to unionize home care, wash. examiner (oct. 31, 2015, 12:01 am), http://www.washingtonexaminer.com/big-labor-trickery-on-display-ineffort-to-unionize-home-care/article/2575302 [http://perma.cc/4b7ecqfn]. 212 paul kersey, union recruiters have been relentless in making sure that caregivers get to hear the union pitch, ill. pol’y (nov. 18, 466 indiana health law review vol 13:2 workers are not interested in having their personal information divulged to third parties, per union directives.213 second, as illustrated by the prices, many employers lack the resources to continue paying caregivers for the same amount of hours if wages are increased. while the care that is received by people with disabilities is often essential, the realities of today’s economy mean that demand is not unceasingly elastic. sometimes families, like the prices, will provide uncompensated care themselves. others will not have this capacity, leaving the person in need of care to simply suffer without it. either way, the home care worker loses the ability to earn a portion of income previously attained. thus, while unions have played an increasing role in home care over the preceding decades, this involvement has not been unanimously embraced. union victories have sometimes been championed at the expense of workers. the home care rule, which can be construed as another union victory, similarly brings negative consequences for the workers who have been heralded as its beneficiaries. b. pragmatic effects for home care workers certainly, the dol is correct to recognize that caregiving is an important job and caregivers deserve decent wages. as discussed, caregivers enable people with disabilities to perform activities of daily living. this, in turn, enables people with disabilities to contribute to their communities through community engagement, employment, and family life. although this author is unwilling to describe home care work as necessarily “strenuous”214 or “physically demanding 2014), http://www.illinoispolicy.org/proposed-law-force-parents-attendunion-led-training/ [http://perma.cc/vdt4-sh54]. 213 mike dennison, governor, union want in-home health worker info public; bill would keep it private, missoulian (apr. 9. 2015), http://missoulian.com/business/local/governor-union-want-in-homehealth-worker-info-public-bill/article_d77a143a-d327-5b10-b9dba749e3b25ecc.html [http://perma.cc/cy4z-uqzk]. 214 brief of women’s rights, civil rights, and human rights organizations and scholars as amici curiae in support of defendantsappellants seeking reversal supra note 187, at 22. 2016 467 help that hurts: how dol’s home care rule harms people with disabilities and caregivers and emotionally draining,”215 it does take patience, diligence, and compassion. not everyone can succeed as a caregiver, but those that do should receive fair compensation. unfortunately, those providing home care services are often paid too little. in 2015, the median pay rate for a home health aide was $10.54.216 a personal care aide could expect to receive even less, on average, with a 2015 median hourly pay rate of $10.09 per hour.217 in promulgating the home care rule, the dol specifically looked at these two occupational categories and stated that the low income associated with these jobs is problematic.218 nevertheless, it is not clear that the home care rule will actually benefit these employees. however, the dol recognizes “very few [home care workers] work overtime” when employed by agencies.219 thus, few stand to benefit from the new overtime provisions. even so, the few workers who may be eligible for overtime under the new regulations are unlikely to receive it. the dol actually notes: “there is no reason to believe the agencies will simply continue current staffing patterns and pay workers overtime for any hours exceeding 40 per week.”220 instead, agencies will cut hours, potentially reducing the total income home care workers received under the previous regulations. in fact, in the notice of proposed rulemaking, the dol offers agencies the option to “choose not to allow staff to exceed 40 work hours per week.”221 215 peggie r. smith, aging and caring in the home: regulating paid domesticity in the twenty-first century, 92 iowa l. rev. 1835, 1849 (2007). 216 occupational outlook handbook, bureau of labor statistics (dec. 17, 2015), http://www.bls.gov/ooh/healthcare/home-healthaides.htm [http://perma.cc/jxv3-ftt6]. 217 id. 218 application of the fair labor standards act to domestic service, 76 fed. reg. 81,192, 81,212 (dec. 27, 2011) (to be codified at 29 c.f.r. pt. 552). 219 id. at 81,213. the dol further admits that it does not have particularly robust or reliable information regarding how employees provide services through consumer-directed care employment relationships. id. at 81,208. 220 id. at 81,220. 221 id. at 81,218. 468 indiana health law review vol 13:2 trapped in pre-allocated budgets, and unwilling to take on the administrative burden of more closely managing the hours of each home care worker, states are planning to implement similar, and sometimes more draconian, measures. arkansas not only proposed a forty-hour weekly cap on the number of hours an attendant care worker may work each week, but also proposed limiting workers to providing assistance for only one medicaid beneficiary.222 if a caregiver works forty hours a week with multiple clients (e.g., ten hours each week with john and thirty hours each week with nancy), she will need to choose which client with which she wants to continue working. no matter her choice, she faces a reduction in total hours worked. unless she can find a private pay client, she also likely faces a reduction in income. ohio proposed eliminating its independent provider program entirely.223 the proposal would require over 13,000 home care workers to find work with a home care agency in order to continue providing services.224 in addition to being detrimental to recipients of care, the elimination of the independent provider program is also injurious to providers. caregivers would be required to find new jobs. even if a caregiver manages to get hired by the agency that serves her current clients, she no longer works directly with them, but must be supervised by an agency middleman. indeed, serving as an independent provider offers caregivers the opportunity to partake in benefits that the traditional agency model does not offer. consider that 85% of workers in consumer-directed care programs felt as though 222 arkansas department of human services division of medical services, alternatives for adults with physical disabilities waiver (oct. 31, 2014), http://170.94.37.152/regs/016.06.14-026p-14580.pdf [http:// perma.cc/l63m-m4gs]. 223 governor proposes changes affecting independent providers of home care, disability rights ohio (mar. 5, 2015), http:// www.disabilityrightsohio.org/news/governor-proposes-changes-affectingindependent-providers-home-care [http://perma.cc/3aab-5235]. 224 gov. john kasich’s budget to phase out independent health worker option, ohio.com, http://www.ohio.com/news/break-news/govjohn-kasich-s-budget-to-phase-out-independent-health-worker-option1.565510 [http://perma.cc/fy4a-53tz] (last updated feb. 10, 2015, 1:29 pm). 2016 469 help that hurts: how dol’s home care rule harms people with disabilities and caregivers they had close relationships with their employers, while only 55% of caregivers from agencies felt close to the recipients of their care.225 additionally, despite the poor pay, “about 45% of directly hired workers reported being very satisfied with their wages and benefits. . . . in contrast, 22% of agency workers report being very satisfied . . . .”226 as such, there is evidence that working outside of the agency model offers caregivers increased job satisfaction and overall well-being. the new regulations jeopardize the continuance of these agreeable conditions, and fail to recognize that a job is more than a mere paycheck. nonetheless, it is critical to note that the paychecks of some independent caregivers may also be completely at risk. other states are exploring whether it is appropriate to maintain consumer-directed care programs in the wake of the new rule.227 over 800,000 participants may be affected.228 of the participating providers, many are family members of care recipients. when given the option, many receiving consumer-directed care prefer hiring relatives.229 these caregivers are unlikely to work for other clients, and are more likely to continue caring for their relative without any compensation. after all, this is what many had done before becoming an independent provider was possible.230 therefore, if the rule forces states to eliminate or shrink jobs for independent providers, these providers may leave the labor force entirely. 225 stacy dale et al., how do hired workers fare under consumerdirected personal care?, 45 the gerontologist 583, 588 (2005). 226 id. 227 e-mail from allison barkoff, dir. of advocacy, bazelon ctr. for mental health law, to emily munson (oct. 8, 2015, 8:35 pm est) (on file with author). 228 medicaid offering participant-directed long-term care services, ahc media (mar. 1, 2011) http://www.ahcmedia.com/articles/129911medicaid-offering-participant-directed-long-term-care-services [http:// perm.cc/8lbr-f9ky]. 229 newcomer, supra, at 140. 230 kathryn g. kietzman et al., whose choice? self-determination and the motivations of paid family and friend caregivers, 44 j. of comp. fam. stud. 519, 531 (2013). http://dx.doi.org/10.1093/geront/45.5.583 470 indiana health law review vol 13:2 v. conclusion home care workers deserve wages that reflect the importance and value of their work. people with disabilities deserve choice in how their activities of daily living are conducted and who provides assistance, as well as possess the right to live in the community. rather than working with both of these groups to develop a feasible solution honoring the interests of those directly involved in home-based caregiving, the dol took it upon itself to act.231 perhaps the dol was acting with the best of intentions. nevertheless, those within the beltway especially should know where good intentions lead. people with disabilities are at risk of perishing in hell on earth232–nursing homes and other institutional placements. even if they manage to stay in their homes, access to the community will be limited, continuity of care will be diminished, and respect for privacy and personal autonomy will fade away. those providing care will not fare better. as states experiment with home care methods, some will lose their jobs, others will merely lose the autonomy gained by serving as independent providers. job satisfaction will diminish, as workers are torn away from their favorite clients and limited in the types of assistance they can provide, despite their own desires to help. disability advocates and home care workers must come together with a coherent strategy. first, and most quickly, congress could once again attempt to remove regulatory power over domestic service provisions of the flsa from the executive branch. this legislation would result in decisionmakers being accountable to voters. second, the doj must 231 letter from cathy cranston and david wittie to senator harry reid, senator mitch mcconnell, and speaker john boehner (nov. 11, 2014), available at https://view.officeapps.live.com/op/view.aspx?src= http%3a%2f%2fwww.ancor.org%2fsites%2fdefault%2ffiles%2fnews %2fadapt_-_dol_congress_letter.doc [http://perma.cc/e5ct-b8qy]. although the dol spoke with union officials while developing the proposed regulations, people with disabilities were excluded from the discussion. id. 232 real life nursing home horror stories, adapt, http://www.adapt.org/cca.rlnhhs [http://perma.cc/3q9r-4ewl] (last visited apr. 11, 2016). 2016 471 help that hurts: how dol’s home care rule harms people with disabilities and caregivers be vigilant of olmstead violations and repeatedly remind states of their responsibility to place individuals with disabilities in the least restrictive environment. longer-term solutions must also be considered. congress must develop a comprehensive strategy for the provision of long-term care. although the patient protection and affordable care act is a start, its more inclusive provisions were removed prior to passage.233 the 2016 election will be a good opportunity for candidates to introduce and discuss their plans for amending the healthcare delivery system, including methods of delivering long-term care. additionally, emphasis must also be placed on raising medicare reimbursement rates, which may drive individual states to similarly raise medicaid reimbursement rates. if advocates had started there, perhaps the home care rule would not be the threat that it is today. 233 associated press, house votes to repeal class act, politico (feb. 1, 2012, 11:46 pm), http://www.politico.com/story/2012/02/housevotes-to-repeal-class-act-072353 [http://perma.cc/xvd5-dch2]. the community living assistance services and supports (class) act would have permitted individuals, including those with disabilities, to participate in a voluntary long-term care insurance program. in the event that a participant would become disabled and need long-term care, they would receive a daily cash allowance to pay for care. thus, the individual would be free to make their own care arrangements, free from medicaid or medicare restrictions. is anyone listening? the legal marginalization of hearing disabilities brendan w. williams* hearing impairment is a common disability. according to the national institute on deafness and other communication disorders, as many as 3 babies out of 1,000 born in the united states have detectable hearing loss.1 as one ages, the chances of hearing loss increase.2 roughly 2% of those aged forty-five to fifty-four have a disabling hearing loss, a rate that grows to 8.5% of those aged fifty-five to sixty-four; almost one-quarter of those aged sixty-five to seventyfour; and half of those seventy-five and older.3 yet for the millions of americans who might benefit from hearing aids–28.8 million adults, as of a 2016 calculation–relatively few will use them.4 that includes only 16% of those aged twenty to sixty-nine who could benefit.5 in most states, health insurance is not required to cover hearing aids, or even hearing exams. those states that do have hearing aid insurance mandates tend to confine them to children.6 twenty-two states have such a requirement.7 only four states–arkansas, connecticut, new hampshire, and rhode island–require coverage for hearing aids for both children and adults.8 hearing aids are very expensive, ranging from $900 to $3,500 or more per ear.9 without insurance, that cost must be born out-of-pocket. yet, according to a may 2018 report from the federal reserve, “[f]our in ten adults, if faced with an unexpected expense of $400, would either not be able to cover it or would cover it by selling something or borrowing money.”10 given the correlation between aging and hearing loss, one might expect * attorney brendan williams is a nationally-published writer on health care and civil rights issues. m.a., washington state university; j.d., university of washington school of law. this article is dedicated to audiologists, overwhelmingly-women, who are too often as marginalized as their patients. 1. nat’l inst. on deafness & other comms. disorders, quick statistics about hearing, nat’l insts. health (dec. 15, 2016), https://www.nidcd.nih.gov/health/statistics/quick-statisticshearing [https://perma.cc/5ckx-u453]. 2. id. 3. id. 4. id. 5. id. 6. state insurance mandates for hearing aids, am. speech-language-hearing ass’n, https://www.asha.org/advocacy/state/issues/ha_reimbursement/ [https://perma.cc/6leu-4ulp]. 7. id. wisconsin also requires that health plans cover children’s cochlear implants. id. 8. id. 9. karen weintraub, why are hearing aids so expensive?, n.y. times (oct. 20, 2017), https://www.nytimes.com/2017/10/20/well/live/why-are-hearing-aids-so-expensive.html [https://perma.cc/xv7z-juf4]. 10. federal reserve board issues report on the economic well-being of u.s. households, federal reserve (may 22, 2018), https://www.federalreserve.gov/newsevents/pressreleases/ other20180522a.htm [https://perma.cc/gm4q-b39u]. http://doi.org/10.18060/3911.0057 134 indiana health law review [vol. 16:133 medicare to cover hearing aids. it does not. indeed, medicare does not even proactively cover hearing exams, although bipartisan legislation has been introduced in the u.s. senate to require at least that much through allowing selfreferred visits to audiologists.11 the consequences of untreated hearing disabilities for the elderly can be severe. as one article notes, “[l]osing the ability to hear well doesn’t just mean people have to turn the volume way up on their favorite tv shows. hearing loss is associated with depression, social isolation and an increased risk for cognitive decline and dementia in older adults.”12 that might create significant additional costs. as one study reported in 2014 found: although the brain becomes smaller with age, the shrinkage seems to be fast-tracked in older adults with hearing loss, according to the results of a study by researchers from johns hopkins and the national institute on aging. the findings add to a growing list of health consequences associated with hearing loss, including increased risk of dementia, falls, hospitalizations, and diminished physical and mental health overall.13 united states representative debbie dingell (d., mich.) has sponsored a bill requiring medicare to cover hearing aids, but the medicare hearing aid coverage act of 2017, with only eight democratic co-sponsors, had received no committee hearing through july 2018.14 the rate of bankruptcy among those 65-and-older is at an all-time high, and, according to a study of those filing for bankruptcy, “[a]bout three in five said unmanageable medical expenses played a role.”15 faced with financial exigency, 11. michelle andrews, can you hear me now? senate bill aims to broaden access to hearing services., kaiser health news (apr. 10, 2018), https://khn.org/news/can-you-hear-menow-senate-bill-on-hearing-aids-may-make-the-answer-yes/ [https://perma.cc/y5zt-9y8f]. 12. id. 13. hearing loss linked to accelerated brain tissue loss, john hopkins med. (jan. 22, 2014), https://www.hopkinsmedicine.org/news/media/releases/hearing_loss_linked_to_accelerated_ brain_tissue_loss_ [https://perma.cc/4fgr-xlt9]. 14. see medicare hearing aid coverage act of 2017, h.r. 3426, 115th cong. (2017). in a 2012 column, one woman wrote, “it came as a shock to me and i’m sure millions of others to realize that the extremely common need for hearing aids wasn’t being met by the safety net for seniors.” ann brenoff, why medicare should pay for hearing aids, huffington post (oct. 23, 2012, 1:49 pm), https://www.huffingtonpost.com/ann-brenoff/say-what-aboutmedicare_b_1954229.html [https://perma.cc/a8wb-v4l2]. of her then 77-year-old husband, she stated: i can only speak from example when i say: no single health issue has impacted my family’s life as much as my husband’s loss of hearing. nope, not even his heart attack and open heart surgery—which, while terrifying at the time, were the wakeup call we needed to launch a healthier lifestyle that includes diet and exercise. id. 15. tara siegel barnard, ‘too little too late’: bankruptcy booms among older americans, 2018] is anyone listening? 135 many seniors will obviously choose to forgo the out-of-pocket cost of hearing aids. the cost of adding hearing aid coverage to medicare is also unlikely to appeal to fiscal hawks, especially with some, including outgoing house speaker paul ryan (r., wis.), blaming “entitlement programs”–not tax cuts–for the federal deficit.16 what is especially incongruous is that medicare’s parsimony regarding hearing aids does not apply to all durable medical equipment, including, most notoriously, the motorized scooters and wheelchairs that have been at the center of fraud claims. as a 2014 washington post investigation reported, “[s]ince 1999, medicare has spent $8.2 billion to procure power wheelchairs and ‘scooters’ for 2.7 million people. today, the government cannot even guess at how much of that money was paid out to scammers.”17 compare this to the fact that a 2018 commonwealth fund report found that “[a]mong medicare beneficiaries, 75 percent of people who needed a hearing aid did not have one.”18 at the state level, the challenge is overcoming the health insurance lobby, which loathes insurance mandates (if not, ironically, the former federal mandate that one have insurance).19 in a national review column, kevin williamson n.y. times (aug. 5, 2018), https://www.nytimes.com/2018/08/05/business/bankruptcy-olderamericans.html [https://perma.cc/t7s7-blca]. 16. see, e.g., nathaniel weixel, ryan eyes push for ‘entitlement reform’ in 2018, the hill (dec. 6, 2017, 5:24 pm), http://thehill.com/homenews/house/363642-ryan-pledges-entitlementreform-in-2018 [https://perma.cc/4pml-8869]. 17. david fahrenthold, a medicare scam that just kept rolling, wash. post (aug. 16, 2014), https://www.washingtonpost.com/sf/national/2014/08/16/a-medicare-scam-that-just-keptrolling/?utm_term=.263b2ab7da43 [https://perma.cc/y98g-hbaz]. though, in other instances where people have needed wheelchairs, insurers have refused to provide them. see jason clayton, iowa medicaid company forced to provide special wheelchairs to disabled clients, des moines reg. (aug. 20, 2018, 6:48 pm), https://www.desmoinesregister.com/story/news/investigations/ 2018/08/20/provide-them-wheelchairs-judges-tell-iowa-medicaid-company/976986002/ [https://perma.cc/th6h-csdf] (explaining that “appeals by unitedhealthcare—each involving a severely disabled iowan who can’t walk independently—lingered for more than a year while the managed care provider denied doctor and state orders that it pay for the specialized equipment.”). 18. amber willink et al., how medicare could provide dental, vision, and hearing care for beneficiaries, commonwealth fund, jan. 18, 2018, at 1, https://www.commonwealthfund. org/publications/issue-briefs/2018/jan/how-medicare-could-provide-dental-vision-and-hearing-care [https://perma.cc/g9kj-qp5l]. 19. a 1997 brief from the conservative heritage foundation asserts, “[b]y singling out mastectomies or maternity care, politicians grant favored status to those suffering from a particular disease or disability, often responding to organized pressure rather than to medical priorities”. carrie gavora, how health insurance mandates misdiagnose the disease, heritage foundation (1997), https://www.heritage.org/health-care-reform/report/how-health-insurancemandates-misdiagnose-the-disease [https://perma.cc/b6dc-bp7y]. 136 indiana health law review [vol. 16:133 argued against a 2017 proposal in texas to mandate insurance coverage of children’s hearing aids: “[i]n the case of an insurance company, the expense of a new mandate might be passed along in the form of higher monthly premiums, or it might be passed along in the form of less generous coverage for other expenses.”20 his opposition was in vain.21 an extreme example of deference to the insurance lobby occurred in the progressive state of washington. there a republican state senator, barbara bailey, introduced a bill to require hearing aid coverage for state employees and those on medicaid.22 it passed into law in 2018.23 according to a press release from the new law’s prime sponsor: “medicaid stopped covering hearing aids in 2011, and this is a longoverdue fix,” said bailey, r-oak harbor. “this is about access and affordability for those suffering from hearing loss, which can mean all the difference. this law will not only help aging populations who are hard of hearing, but also low-income adults and children who may be struggling to succeed in class without access to hearing aids.”24 yet the new law creates a paradox, in that those who have private insurance have no statutory right to hearing aids, or even hearing exams. a senate floor amendment offered to the bill during its 2017 consideration would have rectified this for children on private health insurance: each health benefit plan entered into, or renewed on or after january 1, 2018, shall include coverage for hearing aids for children under the age of eighteen when medically necessary. coverage must include a new hearing aid every five years, a new hearing aid when alterations to the existing hearing aid cannot meet the needs of the child, and services and supplies such as the initial assessment, fitting, adjustment, and auditory training.25 20. kevin d. williamson, mandates are government benefits in disguise, nat’l rev. (mar. 14, 2017, 6:10 pm), https://www.nationalreview.com/corner/there-no-such-thing-free-hearing-aideven-texas/ [https://perma.cc/uk52-3r9p] (statement of rep. rodney anderson) (illustrating that “if we are going to use government, then, by all means, let’s use government in the most honest, transparent, and straightforward way we can. forget the insurance mandate and just write the check.” id. but should that argument apply to all state insurance mandates; e.g., mammograms?). 21. see rep. rodney anderson, a win for texas children: children’s hearing aid bill signed into law, tex. house representatives (june 15, 2017), https://house.texas.gov/ news/press-releases/?id=6315 [https://perma.cc/uxw6-4x5c]. 22. s.b. 5179, 65th leg., reg. sess. (wash. 2017). 23. 2018 wash. sess. laws 827. 24. governor signs duo of bailey health-care bills into law, senator barbara bailey – republican whip (mar. 22, 2018), http://barbarabailey.src.wastateleg.org/governor-signs-duobailey-health-care-bills-law/ [https://perma.cc/np3c-xdv3]. 25. wash. s. amend. 79 to 2s.s.b. 5179 (not adopted mar. 6, 2017), http://lawfilesext. leg.wa.gov/biennium/2017-18/pdf/amendments/senate/5179-s2%20ams%20vand% 2018] is anyone listening? 137 the amendment was defeated on a 25-24 vote, and no effort was made to reintroduce the amendment during the bill’s successful 2018 passage.26 why are we balking at requiring insurers to pay for hearing aids? for a comparison, though obesity is largely preventable, state insurance regulators require health insurers to cover a host of costs related to it. and those costs are not inconsiderable. for example, as one 2015 study notes, “[w]hile not every overweight/obese individual has diabetes, some 80% of those with diabetes are overweight/obese.”27 the study estimates that roughly 21% of all health care expenditures in the united states are obesity-related.28 another study, published in 2016, relates that “[i]n addition to the health consequences of obesity, the yearly economic impact of adult obesity in the u.s. has been estimated at over $315 billion in direct medical costs alone.”29 yet we are doing little to prevent this epidemic. instead, one article relates: “more sugary chocolate milk, fewer whole grains, and around 300 extra milligrams of salt — these are just some of the ways the trump administration has relaxed school-lunch nutrition rules put in place during the obama administration.”30 this deregulation has occurred despite the fact that “[m]ore than half of us children in school today are on track to be obese by age 35.”31 no responsible policymaker is suggesting that health insurance not cover the costs associated with obesity. indeed, obesity has given rise to a common insurance mandate. according to a 2016 analysis from the national conference of state legislatures, “23 states now have a specific health benefit requirement to cover bariatric or gastric bypass surgery, which reduces the physical size of a patient’s stomach and the urge to over-eat.”32 the federal tax bill signed into law in december 2017 provided a major tax cut for alcohol producers – a cut that the leading democrat on the senate finance 20need%20221.pdf [https://perma.cc/hs9e-ezf2]. 26. see roll calls on a bill, s.b. 5179, s. reg. sess. (wash. 2017), http://app.leg.wa.gov/ dlr/rollcall/rollcall.aspx?bienid=24&legnum=5179 [https://perma.cc/338q-mrd8]. 27. adela hruby & frank b. hu, the epidemiology of obesity: a big picture, 33 pharmacoeconomics 7, 10 (2015). 28. id. at 12. 29. julie j. kim et al., asmbs updated position statement on insurance mandated preoperative weight loss requirements, 12 surgery for obesity and related diseases 955, 955 (apr. 18, 2016). 30. hilary brueck, kids are eating less whole grains and more sugary milk in school lunches this year, business insider (jan. 11, 2018, 1:54 pm), https://www.businessinsider. com/trump-administration-relax-school-lunch-rules-2018-1#since-the-2014-2015-school-yearcafeterias-across-the-country-were-required-to-serve-kids-whole-grain-rich-meals-but-notanymore-1 [https://perma.cc/xa2w-2pv2]. 31. id. 32. richard cauchi, most states have expanded health insurance coverage for treatment of obesity; some target obesity, nat’l conf. of st. legis. (mar. 1, 2016), http://www.ncsl.org/ research/health/aca-and-health-mandates-for-obesity.aspx [https://perma.cc/ua3s-v75t]. 138 indiana health law review [vol. 16:133 committee is pushing to make permanent.33 consider the costs of this bipartisanship. an estimated 88,000 americans a year die from excessive drinking.34 one study found that in the united states, “[c]irrhosis-related deaths increased by 65 percent from 1999 to 2016, and deaths from liver cancer doubled, the study said. the rise in death rates was driven predominantly by alcoholinduced disease, the report said.”35 no responsible policymaker is suggesting that health insurance not cover the costs associated with alcohol misuse. so why are the costs associated with hearing disability not worth socializing? in a 2009 report, the council for affordable health insurance, an organization comprised of many insurance company members and organizations representing those providing employer-subsidized health insurance,36 took issue with insurance mandates and offered many of the traditional arguments against them.37 the authors wrote: mandating benefits is like saying to someone in the market for a new car, if you can’t afford a cadillac loaded with options, you have to walk. having that cadillac would be nice, as would having a health insurance policy that covers everything one might want. but drivers with less money can find many other affordable car options; whereas when the price of health insurance soars, few other options exist.38 they stated, “[t]he question that every legislator needs to ask is: when does one person’s or group’s need to have some new or traditionally uncovered procedure or therapy paid for by health insurance outweigh the majority’s need to keep premiums affordable?”39 however, even they quantified the cost of 33. naomi jagoda, alcohol industry pushes lawmakers to uncork excise tax relief, the hill (may 16, 2018), http://thehill.com/business-a-lobbying/387874-alcohol-industry-pusheslawmakers-to-uncork-excise-tax-relief [https://perma.cc/zhh3-lted]. 34. joel achenbach, a huge clinical trial collapses, and research on alcohol remains befuddling, the wash. post (aug. 5, 2018), https://www.washingtonpost.com/national/healthscience/a-huge-clinical-trial-collapses-and-research-on-alcohol-remains-befuddling/ 2018/08/03/d5205bd8-749a-11e8-805c-4b67019fcfe4_story.html?utm_term=.246aa281e47a [https://perma.cc/j4c4-wuyu]. 35. kate furby, alcohol-related liver deaths have increased sharply, the wash. post (july 18, 2018), https://www.washingtonpost.com/news/to-your-health/wp/2018/07/18/alcoholrelated-liver-deaths-have-increased-sharply/?utm_term=.381dc791cc37 [https://perma.cc/29snu82g]. 36. see our members, council for affordable health coverage, https://www.cahc. net/our-members [https://perma.cc/z3cp-6jg9]. 37. see victoria craig bunce & jp wieske, health insurance mandates in the states 2009, council for affordable health ins. (2009), https://www2.cbia.com/ieb/ag/costofcare/ risingcosts/cahi_healthinsurancemandates2009.pdf [https://perma.cc/8c5l-npp4]. 38. id. at 1. 39. id. at 3. 2018] is anyone listening? 139 hearing aid coverage for minors as negligible–less than 1% of premium cost.40 to be sure, some caution with respect to insurance mandates is not unreasonable. for example, in 2011 the washington senate passed a bill innocently entitled “an act relating to insurance coverage of tobacco cessation treatment in the preventative benefit required under the federal law.”41 not so innocently, the bill was pushed by pfizer inc.,42 which makes the drug chantix – a drug known at the time to have the serious side effect of suicidal ideation.43 pfizer went on to pay over $300 million in lawsuit settlements.44 and pfizer itself reported in 2018 that chantix was ineffective in smoking cessation efforts aimed at adolescents.45 yet the science behind the efficacy of hearing aids would appear to be incontrovertible. evidence shows that children with even unilateral (one ear) uncorrected hearing loss “had lower language and verbal iq scores than their siblings with normal hearing.”46 they “are at risk for delays in speech-language development, cognition, and behavioral problems that can affect functioning at school.”47 the most recent states to enact hearing aid insurance mandates were georgia and texas in 2017. reporting on the debate over the two bills is instructive. in georgia, the law is formally known as “the hearing aid coverage for children act.”48 more informally, it is known as “jack’s law,” named—according to a news article—after “georgia teen jack mcconnell, 15, who was the first georgia baby identified with hearing loss after the passage of newborn hearing legislation in 1999.”49 according to that article, children were 40. see id. at 5. 41. s.b 5039, 62nd leg., reg. sess. (wash. 2011). 42. see state of washington, s. comm. health & long-term care, s.b. rep. s.b. 5039, at 3 (feb. 7, 2011). 43. see lilly fowler, quitting smoking can be dangerous to your health, mother jones (dec. 15, 2010, 11:00 am), https://www.motherjones.com/politics/2010/12/quit-smoking-chantixsuicide-pfizer-fda [https://perma.cc/xyd9-ye43]. 44. todd c. frankel, pill that quashes tobacco urge found in plain sight, the wash. post (may 15, 2015), https://www.washingtonpost.com/business/economy/pill-promises-a-safercheaper-way-than-chantix-to-quit-smoking/2015/05/15 /8ce5590c-f830-11e4-9030b4732caefe81_story.html?utm_term=.36c0aa4e67d7 [https://perma.cc/x3lt-nve2]. 45. pfizer’s quit-smoking chantix fails study in adolescent smokers, reuters (mar. 23, 2018, 8:29 am), https://www.reuters.com/article/us-pfizer-chantix/pfizers-quit-smoking-chantixfails-study-in-adolescent-smokers-iduskbn1gz1r9 [https://perma.cc/m7s5-frw4]. 46. j. e. c. lieu, unilateral hearing loss in children: speech-language and school performance (apr. 1, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4382076/ [https:// perma.cc/45ne-jn62]. 47. id. 48. ga. code ann. § 33-24-59.21(2018). 49. jennifer leslie, children’s hearing aid bill becomes law in georgia, 11alive.com (may 9, 2017, 6:11 am) https://www.11alive.com/article/news/childrens-hearing-aid-bill-becomeslaw-in-georgia/438035286 [https://perma.cc/la94-vxly]. 140 indiana health law review [vol. 16:133 “already covered by medicaid and were added to the state health benefit plan, which covers 650,000 state employees, in 2015.”50 the expense turned out to be far less than anticipated, and, based upon this cost experience, a parent advocating the new hearing aid mandate stated it would “cost less than 3-cents per insured individual per month.”51 the georgia’s law’s intent section takes note of the science of hearing aids: the general assembly finds and declares that: (1) the language development of children with partial or total hearing loss may be impaired due hearing loss. children learn the concept of spoken language through auditory stimuli, and the language skills of children who have hearing loss improve when they are provided with hearing aids and access to visual language upon the discovery of hearing loss; and (2) providing hearing aids to children with hearing loss will reduce the costs borne by this state, including special education, alternative treatments that would otherwise be necessary if a hearing aid were not provided, and other costs associated with such hearing loss.52 the law also expressly addresses the issue of cost associated with hearing aids, exempting from the mandate any insurer for which actuarial analysis certifies, to satisfaction of the state’s insurance commissioner, that the costs associated with coverage of children’s hearing aids required under this code section, and not covered as of january 1, 2019, exceeded 1 percent of the premiums charged over the experience period by the insurer, corporation, or health maintenance organization; and (b) such costs solely would lead to an insurance in average premiums charged of more than 1 percent for all insurance policies, subscription contracts, or health care plans commencing on inception or the next renewal date, based on the premium rating methodology and practices the insurer, corporation, health maintenance organization, or governmental entity employs[.]53 based upon the council for affordable health insurance analysis,54 those cost triggers would not appear to be at risk. georgia’s law is one of the nation’s most generous, providing “coverage for the billed charges of one hearing aid per hearing impaired ear not to exceed 50. id. 51. id. 52. ga. code ann. § 33-24-59.21(b) (2018). 53. id. 54. bunce & wieske supra note 37. 2018] is anyone listening? 141 $3,000.00 per hearing aid for covered individuals 18 years and under.”55 these can be replaced every four years at insurer cost.56 georgia is even progressive enough to provide hearing aids to those children who are uninsured and not covered by medicaid. a february 2018 article reported: so if your child isn’t insured through private insurance and you don’t qualify for medicaid where do you go? if you’re caught in the middle here, well, the state has you covered. the vice chair over at the public service commission says new rules mean more children and adults will have access to hearing aids through the state’s hearing aid distribution program.57 in texas, the prime sponsor of the 2017 children’s hearing mandate had previously introduced such legislation in 2015. at that time a mother’s advocacy was reported: “progressive hearing loss means he will continue to lose little hearing, and eventually he’ll be deaf,” chrystal smith said about her 6-year-old son daniel. and keeping up with a bag full of supplies can add up. by the time daniel is 18, she expects to pay more than $40,000 out of pocket. “that doesn’t include the equipment, the battery, the cleaning, the audiologist, the ent, the speech therapy, and all of that,” said smith. texas does not require her insurance to cover hearing aids, like it does for glasses. “we should be saving for college, we’re saving for hearing aids,” said smith.58 of the prime sponsor, representative rodney anderson, the dallas morning news editorialized: “during the 2017 legislative session in austin, the title insurance executive from grand prairie impressively rallied support to change the insurance code to stop insurance companies from denying coverage for hearing aids and cochlear implants to children.”59 the republican’s bill was 55. ga. code ann. § 33-24-59.21(d) (2018). 56. id. 57. dana fowle, state expands hearing aid distribution program, fox5atlanta (feb. 13, 2018, 5:54 pm), http://www.fox5atlanta.com/news/i-team/state-expands-hearing-aiddistribution-program [https://perma.cc/3c5k-n2b6]. 58. phil prazan, texas lawmakers debate coverage for child hearing aids, kxan (may 5, 2015, 6:37 pm), https://www.kxan.com/news/texas-lawmakers-debate-coverage-for-child-hearingaids_20180316011616777/1049568887 [https://perma.cc/d9bu-brkf]. 59. we recommend rodney anderson in the gop primary for state house district 105, 142 indiana health law review [vol. 16:133 opposed by a conservative organization, empower texas, which scored it as antitaxpayer.60 despite this opposition, it still passed the republican house by almost a 6-to1 margin.61 the most generous prescribed insurance mandate is that of oregon, which applies to children under 18, and up to the age of 25 (if “enrolled in a secondary school or an accredited educational institution”), with a cost of up to $4,000 “for one hearing aid per hearing impaired ear” required under statute before inflationadjustment upward began in 2010.62 insurers are required to cover replacements every four years.63 in contrast, connecticut law limited the benefit to $1,000 every two years to children twelve and younger.64 in a 2015 bulletin, the connecticut insurance department deemed the age limit discriminatory; “the insurance department has reviewed the age limit of 12 and under and has determined hearing aids may be clinically effective for all ages, and is therefore requiring carriers to remove the age limits on hearing aid benefits for policies issued or renewed on or after january 1, 2016.”65 although this determination was based upon the affordable care act,66 no other state insurance regulator has followed suit. arkansas law is perhaps the most generous with respect to coverage of hearing aids for both children and adults, mandating coverage of hearing aids of up to $1,400 cost per ear, every three years.67 in contrast, for children and adults, new hampshire mandates coverage of hearing aids of up to $1,500 cost per ear, but only every five years,68 while rhode island mandates coverage for hearing aids of up to $1,500 cost per ear for children up to nineteen-years-old, every three years, but only up to $700 for adults per ear, every three years.69 there would appear to be no political cost to siding with children in requiring dallas morning news (jan. 21, 2018), https://www.dallasnews.com/opinion/editorials/2018/ 01/21/recommend-rodney-anderson-gop-primary-state-housedistrict-105 [https://perma.cc/b7939fmb]. 60. see hb 490: creating a new hearing aid/cochlear implant insurance mandate, empowertexans, https://index.empowertexans.com/votes/2017-house-vote-rv385, [https://perma.cc/rt2f-havx]. 61. id. the texas insurance mandate for children’s hearing aids does not specify a dollar limit, though it expressly does allow for “deductibles” and “coinsurance” payments out-of-pocket. see tex. ins. code ann. § 1367.253(d) (2018). 62. or. rev. stat § 743a.141 (2017). 63. see id. 64. conn. gen. stat. § 38a-490b (2018). 65. state of conn. ins. dep’t, bulletin hc-102, health insurance coverage for hearing aids—conn. gen. stat. § 38a-490b and § 38a-516b (2015), https://www.ct.gov/ cid/lib/cid/hc-102.pdf [https://perma.cc/bxs2-uxyj]. 66. see id. 67. ark. code ann. § 23-79-1402 (2018). 68. n.h. rev. stat. ann. § 415:6-p (2018). 69. 27 r.i. gen. laws § 18-60 (2018). 2018] is anyone listening? 143 insurance companies to cover hearing impairment. in tennessee, a republican state senator, after successfully pushing a hearing aid mandate for children into law, was attacked in his 2012 re-election campaign by a primary challenger who accused him of “‘raising the cost of health insurance by millions of dollars statewide.’”70 the incumbent, who had also supported unsuccessful bariatric surgery mandates, responded: i think what it reflects was just pennies on premiums. ... once they have hearing aids, these children can go to school and keep up with their classmates and graduate high school with their cohort. what we are talking about is improving children’s lives and helping to make them productive citizens.71 the attacks were unsuccessful.72 the greater risk would appear to be a loss of political contributions from health insurance companies. fear of riling the insurance industry can lead to odd results, like washington’s new hearing aid law conferring rights upon children on medicaid, and children of state employees, that children on private insurance do not enjoy. for the 2016 election in the state of washington, for example, premera blue cross gave $241,320 between political candidates for state office and committees.73 in the face of such giving, kids are not much of a barrier. in opposing a 70. joel davis, hughes: overbey dishonest on voting record, daily times (june 26, 2012), h t t ps :/ /w w w . th eda ilyt im es . com /n ews/h u gh es-overbey-d i s h o n e s t -o n -v o t in grecord/article_560c9d5c-db80-514f-9e9c-f793ec3e7659.html [https://perma.cc/vwk2-a4pb]. 71. id. 72. in 2017, the mandate’s prime sponsor, david overbey, still a state senator, was unanimously confirmed by the u.s. senate as a u.s. attorney. see overbey follows proud tradition of united states attorneys, daily times (nov. 12, 2017), https://www.thedailytimes. c o m / o p in io n / ou r_ voice /overbey-fo l lo w s -p r o u d t r a d i t io n -o f -u n i t e d -s t a t e s attorneys/article_9c0f149e-2d5d-54bd-b8c0-eb402b45a669.html [https://perma.cc/gq4r-s3m8]. 73. see contributions, pub. disclosure commission, https://www.pdc.wa.gov/browse/ more-ways-to-follow-the-money/advanced-search/contributions?category=advanced%20search (enter “premera” in contributor data field and “2016” in election year data field) (last visited oct. 6, 2018). as a story in the puget sound business journal once related, “on the chessboard of olympia politics, premera is a queen: nimbly moving in every direction, knowing when to strike and outmaneuvering opponents of all kinds.” valerie bauman, premera’s power politics, puget sound bus. j. (apr. 4, 2014), https://stateofreform.com/wp-content/uploads/2014/07/premerapower-politics.pdf [https://perma.cc/3rff-za6x]. e-mail from sheila tallman, senior manager, premera blue cross, to christine rolfes, senator, washington senate (jan. 21, 2016, 20:54 pst) (on file with author). in washington, the state’s elected insurance commissioner did not require insurers to provide autism benefits to children until a unanimous washington supreme court decision; in a suit brought against an insurer, the court directed the commissioner to do so under the plain meaning of long-existing statute. see o.s.t. ex rel. v. blueshield, 335 p.3d 416, 421 n.9 (wash. 2014) (“regence blueshield’s exclusion was contrary to the plain language of the mental health parity act, and oic’s action (or inaction) is irrelevant.”). 144 indiana health law review [vol. 16:133 previous, stand-alone hearing aid mandate effort, premera had argued, “in wa state, hearing aids are not specifically included in the essential health benefits categories and not included in the benchmark plan.” in other words, benefits should not exceed the “floor” promulgated under the affordable care act.74 pediatric hearing mandate legislation has died even in california, known as a bastion of liberalism,75 after insurance company opposition. most recently, assembly bill 1601,76 introduced in 2017, had the support of a range of groups, including the california children’s hospital association, the california teachers association, and others.77 fatefully, however, ab 1601 was opposed by the insurance industry; according to a summary of their opposition “health benefit mandates stifle the use of innovative, evidence-based medicine.”78 prior mandate legislation introduced by the same house prime sponsor had been killed in 2016 in the senate, and similar bills had been introduced as far back as 2004, according to committee analysis.79 as one article on the bill noted: all newborns in california receive a hearing status screening through the california newborn hearing screening program. yet upon finding out their child’s hearing status, parents are often stunned to find out that interventions and related services are not covered by their health insurance. 74. e-mail from sheila tallman, senior manager, premera blue cross, to christine rolfes, senator, washington senate (jan. 21, 2016, 20:54 pst) (on file with author). in washington, the state’s elected insurance commissioner did not require insurers to provide autism benefits to children until a unanimous washington supreme court decision; in a suit brought against an insurer, the court directed the commissioner to do so under the plain meaning of long-existing statute. see o.s.t. ex rel. v. blueshield, 335 p.3d 416, 421 n.9 (wash. 2014) (“regence blueshield’s exclusion was contrary to the plain language of the mental health parity act, and oic’s action (or inaction) is irrelevant.”). 75. see, e.g., scott wilson, think california politics is on the far-left fringe? just wait for the next elections., wash. post (feb. 3, 2018), https://www.washingtonpost.com/national/thinkcalifornia-politics-is-on-the-far-left-fringe-just-wait-for-the-next-elections/2018/02/04/80e679c205e5-11e8-8777-2a059f168dd2_story.html?noredirect=on&utm_term=.de82a9aa99d1 [https://perma.cc/f2zu-93ut] (“here in the self-labeled ‘state of resistance,’ the political debate is being pushed further left without any sign of a republican renaissance to serve as a check on spending and social policy ambitions.”). 76. assemb. b. 1601, 2017 leg., reg. sess. (cal. 2017). 77. see assembly bill policy committee analysis: hearing on assemb. b. 1601 before the assemb. comm. on health, 2017 leg., reg. sess. (cal. 2017) (statement of kristene mapile, member, assemb. comm. on health). 78. id. at 6. an organization called health access california made its support conditional upon the bill being “amended to extend coverage of hearing aids to adults. according to health access, this bill is contrary to the anti-discrimination provision of the aca based on age.”. id. 79. see id. at 6-7. 2018] is anyone listening? 145 one in ten children in privately funded plans has coverage for hearing aids and hearing aid services, leaving more than 8,000 children without any kind of health insurance coverage for their devices.80 california assembly fiscal staff calculated that passage of the bill would result in no cost to medicaid, which already covered hearing aids for children, but would produce an increase in “employer-funded premium costs in the private insurance market of approximately $13 million” and an increase in “premium expenditures by employees and individuals purchasing insurance of $6 million, and reduced out-of-pocket expenses of $15.5 million . . . .”81 the bill was killed in the assembly appropriations committee.82 conservative idaho might be poised to go in a more progressive direction, based upon a house concurrent resolution that passed in 2018, noting that although medicaid covered hearing aids for idaho children, private insurance did not.83 as the resolution noted, “a child’s inability to obtain these devices is not only detrimental to the child’s success but also costly to idaho schools, which must supply special programming to support the learning needs of children who are deaf or hard of hearing[.]”84 accordingly, the idaho department of insurance was directed to consult with insurers on devising a mandate.85 as was earlier documented for seniors, untreated hearing disabilities can lead to other costs for children. representative anderson, the prime sponsor of the texas insurance mandate, noted it “will allow children with hearing disabilities to develop at the same pace as their peers and will give them the opportunity to attend traditional classrooms instead of special education classrooms.”86 for seniors, as rep. dingell wrote, “[t]he average american may think medicare provides for long-term care, but it has real limitations. they would also be shocked to know medicare does not cover a number of basic needs, such as 80. bloom’s hearing aid bill passes assembly committee, park labrea news & beverly press (may 4, 2017), https://beverlypress.com/2017/05/blooms-hearing-aid-bill-passes-assemblycommittee/ [https://perma.cc/db7c-76xl]. 81. assembly bill policy committee analysis: hearing on assemb. b. 1601 before the assemb. comm. on appropriations, 2017 leg., reg. sess. (cal. 2017) (statement of lisa murawski, member, assemb. comm. on appropriations). 82. bill history, assemb. b. 1601, 2017 leg., reg. sess. (cal. 2017), https://leginfo. legislature.ca.gov/faces/billhistoryclient.xhtml?bill_id=201720180ab1601 [https://perma.cc/ ydz6-urtp]. it was another good session for health insurers. the california assembly speaker had also killed “single-payer” legislation. see, e.g., alexei kosoff, california nurses and anthony rendon are still sparring over single-payer bill, sacramento bee (jan. 17, 2018, 5:45 am), https://www.sacbee.com/news/politics-government/capitol-alert/article195025409.html [https://perma.cc/7hpv-vrtz]. 83. house concurrent res. 45, 64th leg., 2d reg. sess. (idaho 2018). 84. id. 85. id. 86. anderson, supra note 21. 146 indiana health law review [vol. 16:133 hearing aids, glasses, foot care or basic dental.”87 those denied access to hearing aids risk being “cut off from community because you cannot hear.”88 as i wrote once, “[i]magine a treatable disability that afflicts tens of millions of americans and yet is generally uncovered by insurance or medicare. you would think it would prompt a civil rights uprising.”89 over a quarter-century ago, the americans with disabilities act declared that “the nation’s proper goals regarding individuals with disabilities are to assure equality of opportunity, full participation, independent living, and economic selfsufficiency for such individual[.]”90 regrettably, these lofty ideals have not worked out for most who are hearing-impaired.91 are policymakers listening? 87. debbie dingell, aging with dignity out of reach for many in america, detroit free press (july 11, 2015), https://www.freep.com/story/opinion/contributors/2015/07/10/retirementlong-term-care/29998343/ [https://perma.cc/9j8j-ksa5]. 88. id. 89. brendan williams, why are hearing disabilities not covered by insurance and medicare?, the hill, (aug. 5, 2015, 8:00 am), https://thehill.com/blogs/congress-blog/healthcare/ 250195-why-are-hearing-disabilities-not-covered-by-insurance-and [https://perma.cc/eg8aueh2]. 90. americans with disabilities act, 42 u.s.c. § 12101(a)(7) (2018). 91. see kathleen e. bainbridge & virginia ramachandran, hearing aid use among older united states adults: the national health and nutrition examination survey, 2005–2006 and 2009–2010, nat’l health inst. pub. access (2015), https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc3999213/pdf/nihms541764.pdf [https://perma.cc/9xlx-ssdl]. there are other discriminatory dimensions too. the low-income and ethnic minorities are particularly disadvantaged. from the study of adults 70-year-and-older, the authors found, for example, that “[t]he proportion of hearing aid use among non-hispanic white people was over twice that of nonhispanic black, hispanic, or other (including multiracial) people . . . .” id. at 5. ihlr vol 14 iss. 2.pdf http://doi.org/10.18060/3911.0039 https://doi.org/10.1016/j.ijlp.2008.06.004 https://doi.org/10.1037/a0027931 http://doi.org/10.2105/ajph.2013.301680 https://doi.org/10.1176/appi.ps.201300451 have your cake and eat it, too: how states could leverage data on quality to promote health care transparency & patient privacy within consumer-driven health care initiatives have your cake and eat it, too: how states could leverage data on quality to promote health care transparency & patient privacy within consumer-driven health care initiatives julia hudson* abstract....................................... 663 i. consumer-driven health care..................664 a. background ............................... 664 b. cdhc initiatives ...................... ..... 668 1. public ............................. ...... 669 2. private ............................ ...... 674 c. accumulation of health data............. ..... 677 ii. privacy & security concerns .................. 678 a. cdhc & hipaa ....................... ..... 679 1. regulatory framework ............... ...... 679 2. application to cdhc .................. ..... 682 b. re-identification of health data ............... 684 iii. state action to promote transparency and protect privacy ....................................... 687 a. apcds for quality transparency .............. 688 1. apcd legislation. ..................... .... 688 2. focus on quality measures .................. 689 b. incentivize secondary use stewardship... ...... 693 1. market demand for quality information ....... 693 2. stewardship policies .................. ..... 695 iv. strengths & limitations. ......... ............ 697 abstract under the auspices of consumer-driven health care, employers, health insurance companies, and governments are promoting the use of health insurance claims data to j.d. candidate, 2013 indiana university robert h. mckinney school of law; m.p.h. candidate, 2013 indiana university richard m. fairbanks school of public health; b.s., economics, sociology, 2008 creighton university. indiana health law review support informed health care decision-making among consumers. the hope among stakeholders is that consumers will use this information to make efficient health care choices, ultimately driving down health care spending. however, the rich databases derived in the course of these initiatives may also be used in ways that threaten the patient privacy rights envisioned under the health insurance portability and accountability act. part i of this paper addresses how consumer-driven health care currently facilitates commercial practices related to the "secondary use" of health data. part ii describes the nature of the privacy threat, and, finally, part iii suggests specific stateaction that may be taken to allow the public to enjoy the best of both worlds: effective transparency initiatives and stewardship of health data. i. consumer-driven health care a. background the role of the discriminating consumer is central to a well-functioning market economy.' comparisons of price and quality should lead to higher-value purchases by consumers, as well as overall market gains as sellers respond to consumers' behaviors. 2 the wide variation in medical prices in the u.s. suggests that engaged consumers have an opportunity to impact the health care market.3 with health care costs rising independent of improvements in health care outcomes, 4 many see an empowered 1 paul b. ginsburg, shopping for price in medical care, 26 health aff. w208, w209 (2007). 2 id 3 anna d. sinaiko & meredith b. rosenthal, increased price transparency in health care-challenges and potential effects, 364 new eng. j. med. 891, 891 (2011). 4 see dartmouth inst. for health policy & clinical practice, improving quality and curbing health care spending: opportunities for the congress and the obama administration 2 (2008) (describing research findings that expensive, resource-intensive care does not correlate to improved outcomes); see generally ezekiel j. emanuel, it costs more, but is it worth more?, n.y. times 664 vol. 10:2 health care transparency consumer role as an important tool to controlling health care costs.5 under consumer-driven health care (cdhc), consumers are expected to compare cost and quality of care across providers and use this information to make efficient choices about what providers to use and what services to obtain.6 however, when services are covered by insurance, the value of price information to consumers hinges largely on their plan's benefit structure.7 to sensitive consumers to the cost of medical care, cdhc embraces the utilization of highdeductible health plans (hdhps),8 which pair catastrophic insurance coverage with large deductibles. 9 consumerdirected health plans (cdhps) are hdhps that include a tax-advantaged account consumers can use to pay for copayments, coinsurance, and other eligible expenses that are not covered under the health plan. 10 cdhps may be coupled with a health savings account (hsa) or flexible savings account (fsa).11 employers may also offer cdhps based on a health reimbursement arrangement (hra), opinionator blog (jan. 2, 2012, 10:18 pm), http://opinionator.blogs. nytimes.com/2012/01/02/it-costs-more-but-is-it-worth-more/; ezekiel j. emanuel, spending more doesn't make us healthier, n.y. times opinionator blog (oct. 27, 2011, 12:53 pm), http://opinionator.blogs. nytimes.com/2011/10/27/spending-more-doesnt-make-us-healthier/. 5 ginsburg, supra note 1. 6 id. 7 id. at w211. 8 hdhps are defined as "a private health plan with an annual deductible of not less than $1,200 for self-only coverage or $2,400 for family coverage." michael e. martinez & robin a. cohen, health insurance coverage: early release of estimates from the national health interview survey 29 (2011), available at http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201109.pdf. 9 nicolas p. terry, personal health records: directing more costs and risks to consumers., 1 drexel l. rev. 216, 230 (2009), available at http://www.earlemacklaw.drexel.edu/-/media/files/aw/law%20review/ terry.ashx. 10 government accountability office, consumer-directed health plans: health status, spending, and utilization of enrollees in plans based on health reimbursement arrangements 6 (2010) [hereinafter health plans], available at http://www.gao.gov/new.items/d10616.pdf. 11 martinez & cohen, supra note 8. 6652013 indiana health law review which is a type of account that reimburses employees for certain medical expenses. 12 because consumers are financially responsible for a larger share of their health care expenses, they are supposed to be motivated to seek out high-quality, low-cost health care services.13 cdhc is affecting an increasing number of americans through their enrollment in hdhps and other forms of cost sharing.14 between 2006 and 2011, for example, the percentage of americans enrolled in employer-sponsored hdhps increased from 10 percent15 to 27 percent. 16 over 52 percent of individuals who purchase their own health insurance were enrolled in a hdhp in 2011.17 as of january 2012, enrollment in a hdhp with a hsa, in particular, reached 13.5 million americans.' 8 with greater proportions of the nation's health care consumers facing significant financial implications from health care purchasing decisions, the need for transparent cost and quality information is growing.19 more specifically, americans need price and quality information that is easy to access and "actionable." consumers' ease of access to price and quality information is a foremost determinate of the success of cdhc as a 12 health plans, supra note 10, at 7. 13 ann tynan, allison liebhaber & paul b. ginsburg, a health plan work in progress: hospital-physician price and quality transpareny 1 (2008) [hereinafter tynan]. 14 see martinez & cohen, supra note 8, at 6 ("hdhps con-stitute a growing share of both employment-based and directly purchased health plans."). 15 government accountability office, health care price transparency: meaningful price information is difficult for consumers to obtain prior to receiving care 1 (2011) [hereinafter price transparency], available at http://www.gao.gov/new.items/ d11791.pdf. 16 martinez & cohen, supra note 8, at 6. 17 id. 18 ahip center for policy research, january 2012 census shows 13.5 million people covered by health savings account/high-deductible health plan (hsa/hdhps) 1 (2012), available at www.ahip.org/hsa2012/. 19 denise love et al., all-payer claims databases: state initiatives to improve health care transparency 1 (2010). 666 vol. 10:2 health care transparency reform tool. 2 0 historically, however, consumers (and other stakeholders)21 have faced significant, if not impenetrable, barriers to obtaining price information for health care services.22 obviously, consumers cannot use information that they do not have. consumers are also unable to use information that is not meaningful to them. price information must be presented in a meaningful way in order for it to effectively enable consumers. 23 "actionable" price information must (1) enable comparisons between different providers and different treatment options, (2) include the complete cost to the consumer, and (3) be linked to quality data.24 a consumer's complete health care cost should total all costs associated with a given episode of care (including, for instance, lab fees and physician services typically billed separately); reflect any negotiated insurance discounts; and identify the consumer's direct, out-of-pocket expense. 25 quality of care information provides consumers with a context in which to evaluate price differences and apportion health care value. 26 overall, consumers "require credible and accessible information on a wide range of issues, from evidence on what diagnostic and therapeutic strategies are effective to 20 terry, supra note 9, at 229. 21 anne b. claiborne et al., legal impediments to implementing value-based purchasing in healthcare, 35 am. j.l. & med. 442, 477 (2009) ("as a result, consumers (and payors and employer purchasers) often do not understand what they are paying for their healthcare and cannot link cost to quality to derive the overall value of their healthcare."); see also, e.g., shawn leavitt, employers need healthcare price transparency, the hill's congress blog (jan. 31, 2012, 11:37 am), http://thehill.com/blogs/congress-blog/healthcare/207631-shawn-leavittvice-president-global-compensation-and-benefits-at-carlson (last visited may 8, 2013). 22 see generally price transparency, supra note 15, at 12. 23 ginsburg, supra note 1, at w211. 24 california healthcare foundation, making health care costs more transparent to consumers: a summary for policymakers 1 (susan b. kanaan ed., 2008). 25 price transparency, supra note 15, at 2. 26 id. at 9. 2013 667 indiana health law review how providers compare on dimensions of cost and quality"27 in order to function effectively within cdhc. b. cdhc initiatives many health care stakeholders agree that transparency in health care is essential for a higher performing health care system. 28 supporting cost-conscious health care "shopping" through transparency initiatives generally enjoys bipartisan support among policymakers, 29 because of the potential to reduce health care costs without disrupting current payment and delivery systems. 30 among the private sector, the health care opinion leaders survey commissioned by the commonwealth fund in 2007 found that 84 percent of business leaders consider increased transparency in the quality and price of health care services to be important. 31 reflecting this interest, various efforts have been initiated in recent years within the public and private sectors to make health care information available to consumers. between 2010 and 2011, the government accountability office (gao) performed a study of select price transparency initiatives around the country. 32 the gao defined "price transparency initiative" to include "initiatives that make 27 price and quality transparency of medical services: hearing on making health care work for american families' saving money, saving lives, 111th cong. 3 (2009) (statement of paul b. ginsburg, president, center for studying health system change) [hereinafter hearing], available at http://democrats.energycommerce.house.gov/ press_11 1/20090402/testimony-ginsburg.pdf. 28 kristoof stremikis et al., health care opinion leaders' views on transparency and pricing 3 (2010) (finding more than nine out of ten opinion leaders think public access to information on clinical quality, cost, and patient experience is either important or very important), available at http://www.commonwealthfund.org/surveys/ view-all.aspx; but see hearing, supra note 27 ("i continue to be concerned that the promise of transparency is being oversold and overhyped .... ). 29 hearing, supra note 27. 30 ginsburg, supra note 1, at 893. 31 stremikis et al., supra note 28. 32 see generally price transparency, supra note 15. 668 vol. 10:2 health care transparency provider-specific price information on a specific health care service available to consumers and other interested parties."33 the gao found that the information provided by these initiatives varies based on the available data, and that few are able to provide estimates of consumers' complete costs due to limited data and "other obstacles."34 overall, the initiatives tend to provide information about a limited set of hospital or surgical services that are common, comparable, or planned in advance, such as knee replacement or a diagnostic test.35 most of the initiatives also provide a wide range of nonprice information, such as quality of care measures or patient volume. 36 the availability of information on physician quality is less common than hospital quality reporting, "probably because of the difficulty of developing and collecting meaningful statistical quality measures when each physician sees relatively few patients."37 this section will expand upon certain leading public and private transparency initiatives and their emergence in the market. 1. public government-funded transparency initiatives are being conducted at both federal and state levels. in 2001, the centers for medicare and medicaid services (cms) launched the quality initiative to empower consumers with quality of care information and encourage providers to improve the quality of care they deliver.38 this initiative 33 id. at 5. 34 id at 17 (referring to various legal factors cited among respondents as being a barrier). 35 id. at 1. 36 id. at 22. 37 kristin madison, the law and policy of health care quality reporting, 31 campbell l. rev. 215, 219 (2009). 38 centers for medicare & medicaid services, hospital quality initiative overview (2008), available at https://www.cms.gov/ medicare/quality-initiatives-patient-assessment-instruments/hospital qualitylnits/downloads/hospitaloverview.pdf. 2013 669 indiana health law review has developed substantially since then.39 now, consumers can compare hospitals based on quality information, patient satisfaction survey information, and pricing information for specific procedures40 using cms's hospital compare online platform.41 consumers can also access information and make comparisons, to varying degrees, about nursing homes, physicians, home health providers, dialysis facilities, and medicare supplemental insurance plans. 42 however, even cms's more robust hospital comparison measures do not provide specific price information, let alone information about the complete cost to a particular consumer. instead, prices are presented as either higher or lower than the national average and do not reflect beneficiary's cost-sharing obligations.43 because of this and many other limitations to the effective use of compare data, this initiative does not fit within the focus of this paper and will not be discussed further. however, it is worth mentioning that, pursuant to section 10332 of the affordable care act, cms now makes available standardized extracts of medicare claims data to qualified entities for purposes of measuring provider performance. 44 as medicare claims data represent a substantial portion of health care utilization, cost, and outcomes that is otherwise challenging if not impossible to collect, 45 meaningful access to this information could significantly improve the comprehensiveness of transparency initiatives. state governments are responding to cdhc by taking action to gather and make available robust information 39 see generally about hospital compare data, medicare.gov, http://www.medicare.gov/hospitalcompare/data/aboutdata/about.aspx (last visited may 3, 2013). 4 0 id. 41 see hospital compare, medicare.gov, http://www.medicare. gov/hospitalcompare/ (last visited may 3, 2013). 4 2 id. 43 see medicare payment, medicare.gov, http://www.medicare. gov/hospitalcompare/about/hosinfolmedicare-payment. aspx (lastvisited may 3, 2013). 44 see medicare program: availability of medicare data for performance measurement, 76 fed. reg. 76541 (dec. 7, 2011). 45 love et al., supra note 19, at 3. 670 vol. 10:2 health care transparency about the cost and performance of health care providers operating in their state.46 the current data systems in many states leave critical gaps in information. 47 for instance, although almost every state has a hospital discharge data reporting program that includes all patient data for inpatient hospital stays, this data does not include the actual amount of payment made to the facility. 48 nearly twenty states are also missing data from the majority of ambulatory care and pharmacy services, which account for a majority of health care expenditures. 49 to supplement existing reporting requirements and achieve a system-wide view of health care cost and quality, many states are developing all payer claims databases (apcds).50 apcds are "databases, created by state mandate, that typically include data derived from medical claims, pharmacy claims, eligibility files, provider files, and dental claims from private and public payers. in states without a legislative mandate, there may be voluntary reporting of these data."5 1 in other words, apcds contain 'service-level' information based on valid claims processed by health payers, which include data on diagnoses, procedures, care locations, providers, provider payments, and patient demographics. 52 health insurance plans routinely aggregate claims data into their own administrative databases, and apcds combine the data from all payers in a state. 53 as a result, apcds contain the information needed to derive a deeper understanding of costs, quality, and utilization patterns. 54 46 id.at1. 47 see id. at 3 -4. 48 id. at 3. 49 id. 50 id. at 4. 51 id. at 2. 52 nat'l conference of state legislators, pub, collecting health data: all-payer claims databases 1 (2010) [hereinafter ncsl]. 53 love et al., supra note 19, at 2. 54 id. at 2. 2013 671 indiana health law review while voluntary reporting occurs in some states, broad legislative authority appears necessary for the on-going collection and publication of complete, state-wide information.5 5 among other barriers, privacy laws may make it difficult for health plans to release detailed patient data without express legal authority.56 pursuing legislation to ensure participation across the entire spectrum of health care payers is worthwhile because of the capabilities that this level of transparency makes possible: with transparency comes access, for a wide variety of stakeholders, to information that has never before been available, thus creating the ability for actionable and accountable measures. for providers, apcds have the potential to promote quality improvement. payers have information to reward the delivery of high value efficient care. and, consumers have information to make rational choices based on cost and quality information.57 consumers, providers, purchasers, policymakers, and other health care stakeholders are currently using apcds in eight states: kansas, maine, massachusetts, maryland, minnesota, new hampshire, utah, and vermont.5 8 soon, these databases will also be available in colorado, oregon, and tennessee. 59 using data from their apcds, several states have developed websites to communicate cost 55 id. at 2-3, 7-8 (reporting that most voluntary apcd initia-tives cover a limited geographic area or subset of claims data or were established for one-time claims aggregation, and later explaining that voluntary reporting may pose challenges to the public release of comparative reports). 56 id. at 8. 57 denise love et al., all-payer claims databases: an overview for policymakers 6 (2010) [hereinafter love et al. 21. 58 love et al., supra note 19, at 2 (adding that limited, voluntary initiatives have been established in louisiana, wisconsin, and washington state). 59 id. (adding that limited, voluntary initiatives have been established in louisiana, wisconsin, and washington state). 672 vol. 10:2 health care transparency information to consumers. massachusetts,6 0 maine, 61 and new hampshire 62 offer websites that allow consumers to view quality ratings and/or compare pricing of certain medical procedures by health care provider."8 among these states, new hampshire is leading the use of apcd data to further cdhc. in 2003, new hampshire passed a law to create the new hampshire comprehensive health information system (chis).64 health carriers and third party administrators are required to disclose claims data to the state for aggregation into chis.6 5 the data are then to be made "available as a resource for insurers, employers, providers, purchasers of health care, and state agencies . .. to enhance the ability of new hampshire consumers and employers to make informed and cost-effective health care choices." 66 towards this end, new hampshire has created a consumerfocused 67 website, new hampshire healthcost,68 which uses chis data to provide consumers with comparative information about the median total cost 69 a hospital, surgery center, physician or other health care professional receives for its services. 70 insured individuals can input information about their health benefits coverage, and healthcost will calculate their out-of-pocket cost as well as a total cost that is inclusive of any negotiated discounts on 60 see myhealthcareoptions, http://hcqcc.hcf.state.ma.us/default. aspx (last visited may 3, 2013). 61 see mainehealth, http://www.mainehealth.org/mhbody.cfm? id=6536 (last visited may 3, 2013). 62 see nh healthcost, http://www.nhhealthcost.org/ (last visited may 3, 2013). 63 love et al. 2, supra note 57. 64 n.h. rev. stat. § 420-g:11; see generally new hampshire comprehensive health care information system, http://www.nhchis. org/ (last visited may 3, 2013). 65 n.h. rev. stat. § 420-g:11. 66 n.h. rev. stat. § 420-g:11. 67 love et al. 2, supra note 57, at 5-6. 68 nh healthcost, supra note 62. 69 health cost for consumers methodology, nh healthcost, http://www.nhhealthcost.org/method.aspx (last visited may 3, 2013). 70 ncsl, supra note 52, at 2. 6732013 indiana health law review providers' billed charge.71 thus, healthcost provides consumers with an estimate of the complete health care cost for a given service. 72 new hampshire has also been able to use chis data to create a tiered-network insurance product for the small group marketplace. 73 overall, having access to claims data has allowed new hampshire to produce health care cost and quality information relevant to a wide range of stakeholders. 74 2. priva te in contrast to many public transparency initiatives, private sector transparency initiatives have been established voluntarily in response to demand in the marketplace from a variety of sources. 75 more individuals enrolled in hdhps means that more consumers need help accessing and using price and quality information.76 many health plans, especially national insurers, are providing this information to enrollees in an effort to serve as a valued intermediary and gain competitive advantage.77 a strength of the transparency initiatives developed by health plans is that they provide consumers with even more thoroughly tailored information. for example, aetna's price transparency website incorporates, in real-time, an enrollee's partially exhausted deductible into calculations of out-of-pocket costs.7 8 ultimately, health plans are hoping 71 price transparency, supra note 15, at 25. 72 id, 73 love et al. 2, supra note 57, at 1. 74 see, e.g., id. (allowing employers to compare variations in the cost and utilization of services by geographic area and provider setting); ncsl, supra note 52, at 2 (allowing employers to compare health plan premiums and benefits across health insurance carriers). 75 price transparency, supra note 15, at 10. 76 tynan, supra note 13, at 7. 77 id.; see, e.g., press release: wellpoint announces new suite of online tools to support consumer-driven health, wellpoint (sept. 21, 2005), http://ir.wellpoint.com/phoenix.zhtml?c= 130104&p=irol-news article&id=759332&highlight= (last visited may 8, 2013) ("subimo is delighted to expand our relationship with wellpoint as they look to lead in consumer-driven health care."). 78 price transparency, supra note 15, at 25. 674 vol. 10:2 health care transparency that enrollees with access to provider price and quality information will be more likely to use physicians and hospitals that provide efficient, high-value health care services. 79 many of the benefits to consumers from transparency initiatives also apply to employers, particularly those offering cdhps.80 large employers realize that a broad consumerism strategy, where employees are taking more responsibility for health care costs and treatment decisions, requires the availability of price and quality information.81 the pressure by large employers for health plans to provide price and quality information has been a significant factor in spurring the developing of transparency initiatives.82 thus, embracing transparency has been one way for health plans to create new value for employer clients, as well. 8 3 similarly, financial institutions may develop transparency initiatives in response to the steady increase in the number of individuals enrolled in cdhps.84 financial institutions are related to cdhc in their capacity as administrators of hsas, fsas, and hras. many employers who offer cdhps with these types of accounts provide employees with a health benefit card, which is essentially a debit card pre-loaded with the funds contributed to the employee's hsa, fsa, or hra account.85 for example, since at least 2006, u.s. bank has been providing cost and quality information to the bank's institutional clients' employees and retail customers. 8 6 in addition, many large, self-insured employers are interested in providing transparency tools for their 7 tynan, supra note 13. so love et al. 2, supra note 57, at 6. 81 tynan, supra note 13. 82 id. at 2. 83 id. at 2. 84 karen krebsbach, hsas: us. bank, subimo to share platform, american banker (feb. 1, 2006, 2:00 am), http://www.americanbanker. com/magazine/116_2/-270255-1.html?zkprintable=true (last visited may 3, 2013). 85 card holders, sigis, http://www.sig-is.org/card-holders (last visited may 3, 2013). 86 krebsbach, supra note 84. 2013 675 indiana health law review employees directly.87 however, these employers may be challenged by the fact that they have employees enrolled under multiple health plans, making it necessary to aggregate claims across payer systems. for example, ems, a hopkins, massachusetts-based company, realized it had employee claims scattered across thirty-eight different health plans when it began to plan its own transparency initiative. 88 furthermore, such employers may want to adopt consumer platforms that not only provide employees with price and quality information, but also enable employees to manage health data in personal health records in an effort to realize greater cost savings by encouraging employees to take responsibility for lifestyle choices as well as treatment decisions.89 needless to say, these initiatives are a significant undertaking for employers, financial institutions, and insurers, alike. to address the technology issues associated with cdhc initiatives, employers, health plans, and financial institutions are turning to health information and application vendors.90 in the gao's study of transparency initiatives, it found that most health plans use a vendor to aggregate or manage all of the measures and data sources necessary for their transparency initiatives, with subimo, which was actually acquired by webmd in 2006,91 being the 87 bill roberts, modeling better health care: online tools help employees make wiser health care decisions, 51 hr magazine 93, 94 (2006). 88 joanne wojcik, emc creates data warehouse to analyze health costs. effort produces data-rich phrs for employees, business insurance (june 26, 2011, 6:00 am), http://www. businessinsurance.com/article/20110626/issueo3/306269988 (last visited may 8, 2013). 89 kenneth d. mandl & isaac s. kohane, tectonic shifts in the health information economy, sounding board, 358 new eng. j. med. 1732, 1732 (2008); see, e.g., wojcik, supra note 88. 90 kate ackerman, consumers tap online tools to better man -age their health, ihealthbeat (jan. 29, 2008), http://www.ihealthbeat. org/features/2008/consumers-tap-online-tools-to-better-manage-theirhealth.aspx (last visited may 3, 2013). 91 see eric wicklund, webmd to acquire subimo, healthcare it news (nov. 2, 2006), http://www.healthcareitnews.com/news/webmdacquire-subimo (last visited may 8, 2013). 676 vol. 10:2 health care transparency most common vendor used.92 however, a number of other vendors also offer consumer-focused platforms and data management services, including castlight health, 93 optuminsight, 94 and compass healthcare advisors. 9 5 overall, the technology companies supplying the backbone to cdhc initiatives are taking an integral and transformative role in the management of health care information. c. accumulation of health data the result of all this activity around cdhc may be "the largest, richest, and most up-to-date body of health data on a group of individuals."96 collecting a large body of claims into one data system permits a longitudinal view on the health status and health care utilization of individual patients. 97 the comprehensive nature of this data and its related ability to reveal utilization patterns makes it immeasurably more valuable for commercial uses. 98 furthermore, the consumer-driven model of data aggregation has the effect of significantly enhancing data liquidity. 99 in effect, "the potential for abuse is immense. 00 the desirability of this data is significant because organizations with health data often sell it.101 typically, 92 tynan, supra note 13, at 5. 93 castlight health, http://www.castlighthealth.com/ (last visited may 3, 2013). 94 optuminsight, http://www.optuminsight.com/ (last visited may 3, 2013). 95 smartshopper, https://www.compasssmartshopper.com/ (last visited may 3, 2013). 96 mandl & kohane, supra note 89, at 1734. 97 see nicolas p. terry, what's wrong with health privacy?, 5 j. health & biomedical l. 1, 20 (2009) [hereinafter health privacy] (consolidating information silos creates longitudinal patient data). 98 id. at 23. 99 mandl & kohane, supra note 89, at 1733. 100 health privacy, supra note 97, at 23. 101 marc a. rodwin, patient data: property, privacy, & the public interest, 36 am. j.l. & med. 586, 588 (2010). the unsettled issues surrounding patient data ownership are important but outside the scope of this paper. 6772013 indiana health law review this data is first anonymizedl 02 and then sold to entities like commercial aggregators or data miners. 103 the term "medical information organization" refers to the specialized firms that broker the buying and selling of medical data.104 the commercial collection, compilation, and manipulation of health information are "secondary uses" of health data, a term which may be applied to any use of health data that is not for treatment, payment, or health care operations. 05 concerns have been mounting that the growing market for secondary uses of longitudinal patient data and the development of new technologies for manipulating these databases presents a significant threat to the patient confidentiality regime envisioned under hipaa.106 ii. privacy & security concerns assessing the privacy threat posed by the secondary use of data derived through cdhc transparency initiatives requires understanding the ways in which hipaa does and does not regulate health information and the entities that possess it. 102 id. 103 c. christine porter, de-identified data and third party da-ta mining the risk of re-identfication of personal information, 5 shidler j.l. com. & tech. 3, at para. 2 (2008), available at http:/ digital.law.washington.eduldspace-law/bitstream/handle/1773.1/417/vol5 nol_art3.pdf. 104 rodwin, supra note 101, at 590. 105 nat'l comm. on vital health statistics, enhanced protections for uses of health data: a stewardship framework for "secondary uses" of electronically collected and transmitted health data 11 (2007), available at http://www.ncvhs.hhs.gov/ 0712211t.pdf. 106 see nicolas p. terry, legal issues related to data access, pooling, and use, in clinical data as the basic staple of health learning: creating and protecting a public good 151, 159-161 (claudia grossmann et al., eds., 2010). 678 vol. 10:2 health care transparency a. cdhc & hipaa 1. regulatory framework the health insurance portability and accountability act of 1996 (hipaa) was enacted to effectuate standards for the electronic exchange, privacy, and security of certain health information.107 the hipaa privacy rule108 (privacy rule) establishes national standards governing the use and disclosure of individuals' medical records and other personal health information. 109 these standards are operationalized into specific safeguards under the hipaa security rule 10 (security rule)."' collectively, these rules are intended to protect patient privacy without hindering the delivery of medical treatment or public health and well-being. 112 hipaa's privacy and security standards apply to protected health information held by covered entities1 13 and their business associates. 114 "protected health information" (phi) includes individually identifiable health information transmitted or maintained in electronic form. 15 "individually identifiable health information" includes information that "relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual" if such information identifies the individual or one could reasonably believe that the 107 dep't health & human servs., ocr privacy brief, sum-mary of the hipaa privacy rule 1 (2003). 108 see 45 c.f.r. § 160 (2012); 45 c.f.r. § 164(a-e) (2012). 109 ocr privacy brief, supra note 107. 110 see 45 c.f.r. § 160 (2012); 45 c.f.r. § 164(a, c) (2012). 111 summary of the hipaa security rule, hhs.gov, http://www. hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html (last visited may 3, 2013). 112 ocr privacy brief, supra note 107 (describing a "major goal" of the privacy rule); summary of the hipaa security rule, supra note 111 (describing a "major goal" of the security rule). 113 45 c.f.r. §§ 164.302; 164.500 (2012). 114 42 u.s.c. §§ 17931; 17934. 115 45 c.f.r. § 160.103 (2012). 6792013 indiana health law review information could be used to identify the individual. 116 thus, hipaa attempts to protect only a subset of health data. 117 similarly, only certain custodians of "individually identifiable health information" are subject to the privacy rule and security rule. 118 these "covered entities" are health plans, health care clearinghouses, and health care providers who engage in hipaa electronic transactions. 119 third party vendors are also subject to hipaa in their capacity as a "business associate" of a covered entity. a "business associate" performs a function or activity or provides a service on behalf of a covered entity that requires the use or disclosure of personally identifiable health information.120 hipaa requires that covered entities establish written agreements commonly referred to as "business associate agreements" (baas) in order to disclose the necessary1 21 phi to a business associate. 122 baas must "establish the permitted and required uses and disclosures of [phi] by the business associate,"123 and "may not authorize the business associate to use or further 116 id. 117 see 45 c.f.r. § 160.103 (2012) (stating that "individually identifiable health information is information that is a subset of health information"). 118 hipaa privacy rule & public health: guidance from cdc and us. department of health & human services, cdc (apr. 11, 2003), http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e41lal.htm (last visited may 8, 2013) [hereinafter guidance from odc} (pointing out that other entities who regularly use, disclose, or store "individually identifiable health information," like auto or life insurers, are not subject to the privacy rule). 119 45 c.f.r. § 160.103 (2012). 120 id. 121 "when using or disclosing protected health information . . . , a covered entity must make reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose .. . ." 45 c.f.r. § 164.502(b)(1). 122 45 c.f.r. § 164.502(e)(1) (2012) ("a covered entity may dis-close [phi] to a business associate and may allow a business associate to create or receive [phi] on its behalf, if the covered entity obtains satisfactory assurance that the business associate will appropriately safeguard the information."). 123 45 c.f.r. § 164.504(e)(2)(i) (2012). 680 vol. 10:2 health care transparency disclose the information in a manner that would violate [the privacy rule], if done by the covered entity . . . ."124 in effect, baas bind business associates to the same restrictions and limitations on the use and disclosure of phi that apply to the covered entity.125 beyond contractual obligations, business associates are also directly accountable for compliance with certain provisions in the privacy rule and security rule. first, the "health information technology for economic and clinical health" (hitech) act, title xiii of the american recovery and reinvestment act of 2009, extends the application of civil and criminal penalties permitted under hipaa to include business associates who use or disclose phi in violation of their baa.126 second, hitech makes business associates directly subject to certain provisions in the security rule and related civil and criminal penalties. 127 in these respects, business associates are regulated under hipaa as if a covered entity. hipaa requires covered entities (and, thus, their business associates) to ensure the confidentiality of electronic phi and protect against reasonably anticipated threats to the security of such information or uses or disclosures prohibited under the privacy rule.128 the privacy rule effectively prohibits all uses or disclosures of phi that are not expressly permitted or required under its terms.129 generally, covered entities are permitted to use or disclose phi to carry out treatment, payment, or health care operations (tpo).130 the privacy rule also permits covered entities to use or disclose phi as necessary for certain public health activities 131 or to comply with a law,132 124 45 c.f.r. § 164.504(e)(2)(i) (2012). 125 thomas d. bixby & deborah marine, hitech act changes to hipaa: what they mean for health plans 2-3 (2009), available at http://www.healthlawyers.org/events/programs/materials/documents/ ppmc09/bixby-marine.pdf. 126 42 u.s.c. § 17934(c) (2012). 127 42 u.s.c. § 17931(a) (2012). 128 45 c.f.r. §§ 164.306(a); 164.512 (2012). 129 45 c.f.r. § 164.502(a) (2012). 130 45 c.f.r. § 164.506(a) (2012). 131 45 c.f.r. § 164.512(b) (2012). 6812013 indiana health law review including state and local reporting laws and regulations. 133 another permitted use of phi is to create health information that is not "individually identifiable health information." 134 covered entities may disclose phi to business associates for that purpose, as well, regardless of whether or not de-identification is on behalf of the covered entity.135 in other words, business associates are permitted to de-identify phi for their own, independent purposes. covered entities or business associates must follow one of two "implementation specifications" for de-identification of phi:136 statistical de-identification or the safe harbor method. 137 statistical de-identification requires a qualified statistician to conclude that the risk of the information being used, alone or in combination with other information, to identify the individual to whom the information pertains is "very small."13 8 more commonly, de-identification occurs by removing seventeen specified identifiers, as well as any other unique identifying code. 139 health information that has been de-identified in accordance with these specifications is no longer "individually identifiable health information,"140 or, therefore, phi. once individually identifiable health information has been de-identified, "it requires no individual privacy protections" and may be used or disclosed without regard to the privacy rule.141 2. application to cdhc whether the privacy rule and security rule are relevant to cdhc initiatives depends initially on whether 132 45 c.f.r. § 164.512(a) (2012). 133 guidance from cdc, supra note 118, at 2. 134 45 c.f.r. § 164.502(d)(1) (2012). 135 id. ("a covered entity may . . . disclose protected health information only to a business associate for such purpose, whether or not the de-identified information is to be used by the covered entity."). 136 45 c.f.r. §§ 164.502(d)(2); 164.514(b) (2012). 137 guidance from cdc, supra note 118. 138 45 c.f.r. § 164.514(b)(1) (2012). 139 45 c.f.r. § 164.514(b)(2) (2012). 140 45 c.f.r. § 164.502(d)(2) (2012). 141 guidance from cdc, supra note 118. 682 vol. 10: 2 health care transparency claims data is phi and whether entities engaged in transparency initiatives are "covered entities" or "business associates." claims data are generated for billing purposes, and therefore necessarily contain identifying information related to an individual's health condition and/or treatment(s) received. in other words, claims data contain "individually identifiable health information." in addition, the entities engaged in transparency initiatives are "covered entities" or "business associates." first, state agencies managing apcds probably meet the definition of a covered entity as a healthcare clearing house, 142 but data privacy and security is typically addressed by the enabling legislation or implementing regulations. 143 second, health plans, including those offered by large, self-insured employers, are specifically identified as a covered entity.14 4 a financial institution is a "business associate" when it administers hsas, fsas, or health benefit cards on behalf of a health plan.145 generally, financial institutions146 are exempt from hipaa regulations when using or disclosing information for payment administration services for health plan premiums or health care when payment is made by "any means, including a credit, debit, or other payment card . . . ."147 however, the term "other payment cards" was not intended to include health benefit cards, which are used for identification of individual, plan, and benefits. 148 thus, financial institutions engaged in cdhc initiatives are subject to hipaa. finally, technology companies that serve as health information and application vendors for these entities are 142 45 c.f.r. § 160.103 (2012). 143 ncsl, supra note 52, at 3. 144 45 c.f.r. § 160.103 (2012). 145 jan hertzberg & cindy davis, what health care legislation means for financial institutions, currency, feb. 2010, at 2. 146 see definition of "financial institution" at 12 u.s.c. § 3401(1). 147 42 u.s.c. § 1320d-8 (2012). 148 standards for privacy of individually identifiable health information, 65 fed. reg. 82,462, 82,617 (dec. 28, 2000) (part ii. section-by-section description of rule provisions), available at https:// federalregister.gov/a/00-32678 (last visited apr. 22, 2013). 2013 683 indiana health law review performing a function for covered entities requiring the use of phi, and thus are business associates under hipaa. baas must be established in order for financial institutions, employers, and health plans to disclose phi to companies like webmd for purposes related to cdhc initiatives. however, in practice, baas often do not specifically describe the permitted uses of phi.149 instead, these contracts include vague statements such as, "the contract covers use and disclose of protected health information only as permitted or required or as otherwise required by law."1 50 without explicit enumeration of the extent and nature of a business associate's use of phi, baas only require compliance with hipaa. thus, technology companies assisting in transparency initiatives may de-identify phi in accordance with hipaa standards. as de-identified data is not protected under hipaa, technology companies and their agents may then use deidentified data without regard to the baa. 151 b. re-identification of healtl2 data like many, if not most, companies that collect personal information, 152 technology companies engaged in cdhc initiatives assure customers that their information will be released only in an anonymous or "patient de-identified" form. 1 53 the underlying assumption, present here as well as within hipaa's regulatory framework, is that what constitutes "identifiable patient information" is a fixed set of attributes, like name and address. 154 remove these 149 nat'l comm. on vital health statistics, supra note 105, at 18. 150 id 151 id. at 28. 152 arvind narayanan & vitaly shmatikov, myths & fallacies of 'personally identifiable information," 53 commc'n acm 24, 25 (2010), available athttp://www.cs.utexas.edu/-shmat/shmatcacm10.pdf. 153 see castlight health privacy policy, castlight health (june 10, 2011), http://www.castlighthealth.com/privacy-policy-2011/ (last visited apr. 22, 2013). 154 narayanan & shmatikov, supra note 152. 684 vol. 10:2 health cahi transparency identifiers, and there is complete anonymity to the individual data subjects.15 5 in contrast, the ability to re-identify health data, even after applying the hipaa definition of de-identification, was noted by the national committee on vital and health statistics (ncvhs) as an area of concern in 2007.156 reidentification is the linkage of de-identified personal information with an overt identifier that belongs or is assigned to an individual. 15 7 re-identification is a growing concern because of the vast amounts of personal information available online and in off-line records systems, as well as new technological abilities158 that challenge the notion of "identifiable" as a binary state.159 a major challenge for de-identification is that the amount of information available about individuals is huge.160 any information that distinguishes among individuals can be used to re-identify de-identified information.161 increasingly, consumers are submitting health information into internet websites like webmd and social network sites, which maintain this information in combination with other personal information.162 the ncvhs's concern about re-identification was particularly pronounced in regards to data stored in these types of merged databases.163 the more personal data that is 155 robert gellman, the deidentification dilemma: a legisla-tive and contractual proposal, 21 fordham intell. prop. media & ent. l.j. 33, 38 (2010). 156 letter from simon p. cohn, chairman, nat'l comm. on vital and health statistics to michael 0. leavitt, secretary, dep't of health & human servs. (dec. 21, 2007), available at http://www.ncvhs.hhs.gov/ 0712211t.pdf. 157 gellman, supra note 155, at 34. 158 paul m. schwartz & daniel j. solove, the piiproblem: privacy and a new concept of personally identifiable information, 86 n.y.u.l. rev. 1814, 1846 (2011). 159 gellman, supra note 155, at 40. 160 id. at 36. 161 narayanan & shmatikov, supra note 152. 162 see gellman, supra note 155, at 36-37. 163 nat'l comm. on vital health statistics, supra note 105, at 5. 2013 685 indiana health law review available, the easier it becomes to trace de-identified information to its data subject. 164 in addition, technology increasingly enables the combination of seemingly non-identifiable information to produce identifiable information.165 researchers have demonstrated the potential for advanced algorithms to reidentify de-identified data.166 however, it should be noted that in most instances when re-identification is known to have occurred, health data was not involved.167 furthermore, the health data was often not de-identified according to hipaa standards.168 when it was, the success rate was very low (.013% of records re-identified).169 on the other hand, most published instances of re-identification were conducted by researchers as demonstration projects.170 it is reasonable to suspect that successful re-identification efforts by other parties are not brought to the public's attention, making it difficult to assess the actual threat posed by re-identification based on the published literature. what is known, however, is that organizations do acquire health data by purchasing hipaa de-identified data.171 some of these organizations then link the data to provider databases to market to providers, or use the data to market to a circumscribed population that is likely to include a population of interest to the organization.172 164 geilman, supra note 155, at 36. 165 schwartz & solove, supra note 158, at 1842. 166 for examples of various exercises conducted by researchers to demonstrate the ease and/or possibility of re-identification see gellman, supra note 155, at 37-39. 167 khaled el emam et al., a systematic review of reidentification attacks on health data, 6 plos one, dec. 2, 2011, at 4, available at http://www.plosone.org/article/info%3adoi%2f10.1371%2f journal.pone.0028071 (finding six of fourteen re-identification attacks involved health data) (last visited apr. 22, 2013). 168 id. at 6 (finding five out of six involved health data not fully deidentified). 169 id. at 9. 170 id. at 5. 171 nat'l comm. on vital health statistics, supra note 105, at 22. 172 id 686 vol. 10:2 health care transparency given the high value americans place on privacy173 and the potential harm from an erosion of trust in the confidentiality within which one's personal health information is supposed to be held within the health care system, 74 the issue of re-identification merits a closer look. as robert gellman puts it: there will always be a tradeoff of some sort, involving the degree of identifiability of the data, the usability of the data, the privacy of the data subjects, and the cost of the deidentification process... what legislation can do, however, is establish a statutory framework that will allow the data disclosers and the data recipients to agree voluntarily on externally enforceable terms that provide privacy protections for the data subjects.175 iii. state action to promote transparency and protect privacy cdhc is a priority among many health care stakeholders. the resulting accumulation of health information has the potential to effectuate improved health care decision making and quality of care. however, the potential secondary uses of such valuable patient information threaten the integrity of the patient privacy rights envisioned under hipaa. this section proposes that states respond to this issue with a two-step approach 173 institute of medicine, beyond the hipaa privacy rule: enhancing privacy, improving health through research 78 (sharyl j. nass et al. eds., 2009). 174 see nat'l comm. on vital health statistics, supra note 105, at 5 (describing the negative impacts that may result from an erosion of trust). 175 gellman, supra note 155, at 47. gellman's proposal is generally consistent with the proposal described in this paper, but the author fails to provide any basis on which to realistically expect (or understand why) data disclosers and data recipients would voluntarily subject themselves to data use limitations and potential criminal penalties and sanctions. 2013 687 indiana health law review designed to support cdhc transparency initiatives as well as patient privacy. a. apcds for quality transparency the first step of the two-step approach is for states to pass laws to create apcds, but to use the databases to promote quality transparency rather than creating consumer platforms for price comparisons. 1. apcd legislation apcds are most likely to be successful when authorized through legislation.176 although voluntary efforts are underway, they typically do not capture all claims in the state. for example, the wisconsin health information organization is a private nonprofit organization incorporated in 2006 by insurers, employers, and providers. however, the initiative only captures no more than half of the health care claims in the state.177 to be effective, apcd legislation should confer broad legal authority for the collection of data from all relevant sources, including health plans, pharmacy benefit managers (pbms), and third-party administrators (tpas).178 specific legal authority is particularly important for ensuring reporting by pbms and tpas.179 in addition, legislation should include or authorize enforcement provisions that penalize these entities for failing to comply with data reporting requirements. 80 states that enact broad and meaningful legislative authority are in a stronger position to enforce reporting compliance and maintain a robust apcd.181 establishing apcds through legislation also reduces barriers imposed by the hipaa privacy rule, which may 176 love et al., supra note 19, at 7. 177 national conference of state legislators, supra note 52, at 3. 178 love et al., supra note 19, at 7. 179 id 180 id 181 id 688 vol. 10:2 health care transparency otherwise make it difficult for private entities to share detailed patient data. 8 2 the majority of apcd legislation authorizes a state agency to collect, manage, and disseminate the data.183 thus, disclosure of phi by health plans and other covered entities to the particular state agency is permitted under hipaa to the extent "required by law."s 4 some states also contract with a private vendor to provide this service, subject to oversight by the authorized state agency.185 furthermore, it may be advantageous for state agencies to partner with an academic organization to perform the data analysis and reports.186 guidance on the hipaa privacy rule suggests that, once disclosure has been exempted as "required by law," the state agency may then share or subcontract their research mandate and related phi to affiliated organizations. 87 2. focus on quality measures however, future initiatives should differ from existing apcds in two ways. first, state reporting requirements should not include price information. second, states should not expend resources developing online consumer platforms for price comparisons. instead, the focus of state efforts should be on using apcds to develop valid quality measures across health care providers. such a change in direction is justified because apcd initiatives have not been effective, primarily attributed to a lack of valid and reliable quality information. although the empirical evidence is limited, research does not suggest that public price transparency initiatives are effective at reducing prices or price variation. first, the california hospital price transparency initiative has been found to have caused a negligible, if any, effect on hospital 182 id. at 8. 183 idat 7. 184 45 c.f.r. § 164.512(a) (2012). 185 love et al., supra note 19, at 7. 186 id 187 claiborne et al., supra note 21, at 503. 2013 689 indiana health law review prices. 188 this finding is not surprising because california's initiative was the public disclosure of hospitals' chargemaster data,189 which is not "actionable" consumer information. however, the gold-standard for apcd initiatives does not appear to be successful, either. a study of the effect of new hampshire's initiative was not able to find a decrease in price variation for 30 (mostly imaging or outpatient surgical) procedures one year after pricing information was made available. 190 why haven't these initiatives been successful? one reason may be that the efforts necessary to temper concerns about the release of insurers' proprietary information and potential for anticompetitive behavior among providers result in price information that is less meaningful to consumers. when the gao interviewed insurance companies about sharing negotiated rates for transparency initiatives, insurers repeatedly raised concerns about the disclosure of proprietary information.191 for instance, one official from an insurer association cited the uniform trade secrets act as prohibiting insurers from sharing their negotiated rates.192 irrespective of the legal merits of such concerns, insurers' resistance to apcd initiatives can be a significant barrier. in florida, officials have not been able to follow through with their legislative authority to collect claims data in part because of the challenges posed by the proprietary concerns of insurers and providers.193 the general lack of competition in many health care markets also raises concerns that the public disclosure of negotiated prices between providers and health plans could support anticompetitive behavior that may actually lead to 188 d. andrew austin & jane g. gravelle, congressional research service, pub. no. rl34101, does price transparency improve market efficiency? implications of empirical evidence in other markets for the health sector crs 26 (2008). 189 id. (referring to the effect of legislation requiring hospitals to make chargemaster data public). 190 sinaiko & rosenthal, supra note 3, at 893. 191 government accountability office, supra note 15, at 15-16. 192 id 193 id. at 27. 690 vol. 10:2 health care transparency higher, not lower, prices.194 pricing information could result in higher prices by facilitating collusion among competing providers, or by simply changing providers' assumptions about how competitors would respond if they decided to reduce prices for an insurer.195 indeed, a lack of competition among providers was cited as the reason why new hampshire's initiative has not been effective. 196 but price transparency may also result in anticompetitive behavior by insurers, who also could collectively agree to exclude certain providers from their networks.197 considering that antitrust analysis is highly fact-specific, any risk of challenge under the antitrust laws may be sufficient to deter providers and insurers from supporting price transparency initiatives.198 to temper these concerns, transparency initiatives make efforts to mask specific rates paid to individual providers for particular services.199 for example, price information may be presented as a range or as the median price paid for the service. consumers may also be given a price aggregated across all health plans. while these efforts address concerns about the release of proprietary information and anticompetitive behavior, pricing information becomes less representative of the cost that consumers will actually pay, making it less meaningful to consumers. consumers tend not to act on information that is not perceived as useful.200 one of the greatest fears associated with transparency initiatives is that consumer misinterpretation of pricing information will lead to greater health care costs. 2 01 the concern is that, in the absence of useful quality information, consumers will interpret high price as being indicative of 194 ginsburg, supra note 1, at w214. 195 id. 196 sinaiko & rosenthal, supra note 3, at 893. 197 claiborne et al., supra note 21, at 479. 198 id. at 479-480. 199 see government accountability office, supra note 15, at 21 (describing various methods of presenting price information). 200 madison, supra note 37, at 227. 201 tynan, supra note 13, at 6. 2013 691 indiana health law review high quality and seek out higher-cost providers. 202 while transparency initiatives typically provide some sort of quality indicator alongside pricing information, consumers may be reluctant to rely on this information for a variety of reasons. first, quality information often regards hospital care, an area in which consumers typically have little discretion.203 in addition, the lack of independent information on clinical quality measures may lead consumers to question their validity, and rely instead on traditional sources of information word of mouth or physician recommendation. 204 the validity of quality measures is, in fact, a concern shared by health care providers, researchers, policymakers, and other health care stakeholders. 2 0 5 consumers need meaningful information about quality alongside prices in order to make the comparisons that are necessary for high-value health care decisions.206 ultimately, many of the challenges posed by apcds are due to the public disclosure of payment information.207 both providers' and insurers' are resistant to reporting these payments, and they are capable of posing significant challenges to states that attempt to undertake price transparency initiatives. 208 at the same time, insurers have shown that they are fully capable of facilitating price transparency on their own, by delivering meaningful price information through consumer-friendly online platforms.209 given that state initiatives have not demonstrated effectiveness and the understanding that transparency initiatives, in general, are limited by the unavailability of 202 id.; sinaiko & rosenthal, supra note 3, at 892 (citing re-search that found that higher prices cause a placebo effect that improves patients' response to treatments). 203 see madison, supra note 37, at 227-228 (explaining that hospital admissions are rare, usually guided by referring physicians, and generally limited to the local geographic area). 204 sinaiko & rosenthal, supra note 2, at 892. 205 madison, supra note 37, at 233. 206 sinaiko & rosenthal, supra note 2, at 893. 207 love et al., supra note 57, at 9. 208 government accountability office, supra note 15, at 27. 209 see ginsburg, supra note 1, at w215. 692 vol. 10:2 health care transparency useful quality information, states should focus on forming apcds in order to develop valid and reliable quality information for cdhc initiatives. b. incentivize secondary use stewardship the second step of the two-step approach is for states to leverage access to the resulting quality information as an incentive for the voluntary adoption of secondary use stewardship policies. 1. market demand for quality information persuading private entities involved in transparency initiatives to limit their commercial use of health information will require offering a powerful incentive.210 these entities have invested significant amounts in their transparency initiatives. 211 however, they nonetheless face several significant impediments to measuring and publishing information about quality.212 if states focus on producing quality information for use by the various private entities engaged in cdhc, states will be filling a critical gap and providing significant value to transparency initiatives. the potential for apcds to yield meaningful quality measures is therefore critical to the adoption of a stewardship policy. many health plans view the ability to provide quality information as an important competitive advantage. 213 at present, however, most plans are merely conduits for the 210 cf william crown, characteristics of the marketplace for medical care data, in clinical data as the basic staple of health learning: creating and protecting a public good: workshop summary 143, 150 (claudia grossmann et al., eds., the national academies press 2010), available at http://www.nap.edulopenbook. php?recordid=12212&page=139 (describing the hesitation of data aggregators to contribute towards a pooled database unless they are able to recoup a value on par with the investment into constructing their database). 211 id. 212 claiborne et al., supra note 21, at 466. 213 tynan, supra note 13, at 6. 6932013 indiana health law review generalized quality information that is publicly available from governments and other third-party sources. 214 as mentioned previously, this information is seriously lacking in physician quality measures. 215 some health plans use their own claims data systems to derive quality and utilization reports that they share with physicians and enrollees.216 this capability is limited by the fact that a single insurer's database is often not large enough to yield statistically significant results at the individual physician level,217 especially if the insurer has a small market share.218 as a result, only a few plans are able to offer substantial quality information on physicians. 219 despite limitations to available quality measures, many health plans have pursued the creation of "highperformance networks" or other performance rating programs for physicians. 220 these networks restructure benefit designs so that consumers are directly incentivized to choose low-price, high-quality providers. 221 but, with each insurer using only its own claims data to develop its quality measures, these efforts are typically not perceived as credible222 and may damage relationships with physicians. 223 rating and tiering programs have faced legal challenges and public scrutiny due to concerns about the validity of the measures used, the accuracy of the underlying data, and the conflation of quality and cost criteria. 224 thus, there is an interest among payers to get access to "invaluable physician quality performance metrics," as evidenced by the recent partnership between 214 id. at 8. 215 madison, supra note 37, at 227-28. 216 love et al., supra note 57, at 7. 217 id. 218 tynan, supra note 13, at 5-6. 219 [d 220 id. at 6. 221 claiborne et al., supra note 21, at 474-75. 222 hearing, supra note 27, at 5. 223 madison, supra note 37, at 236-37. 224 id. at 239; see claiborne et al., supra note 21, at 481-83 (discussing potential legal challenges and public scrutiny by new york attorney general). 694 vol. 10:2 health care transparency castlight health and minnesota community measurement.225 reliable and uniform third-party quality that can assist health plans in improving both the perception and effectiveness of tiering programs 226 would have significant commercial value. 2. ste wardshii policies by offering an attractive trade, entities involved in cdhc initiatives may be very willing to adopt data stewardship practices. health data stewardship refers to the responsibility to safeguard the appropriate use of data derived from individuals' health information. 227 health data stewardship may be accomplished by strengthening accountability through practices that apply to all entities who collect, view, store, exchange, aggregate, analyze, and use22 8 both identified and de-identified data.22 9 ncvhs suggests the following general recommendations for enhanced protections of health data (1) build upon existing legislation and regulation when possible, (2) reduce excessive administrative burden (2) enable improvements in the healthcare delivery system, and (4) maintain or strengthen individual's health information privacy.230 this proposal aims to meet these recommendations through the addition of fairly simple and straightforward language in baas. the stewardship policy advocated here involves two primary dimensions. first, consistent with a 225 press release, castlight health, castlight health and minnesota community measurement partner to deliver vital physician quality data to users (feb. 27, 2012), available at http-//www. healthcareitnews.com/press-release/castlight-health-andminnesotacommunitymeasurement-partner-deliver-vital-physician-q. 226 madison, supra note 37, at 238. 227 national committee on vital health statistics, health data stewardship: what, why, who, how 4 (2009), available at http://www.ncvhs.hhs.gov/0909301t.pdf. 228 id. at 1. 229 id. at 4. 230 see nat'l comm. on vital health statistics, supra note 105, at 26. 6952013 indiana health law review recommendation of the ncvhs, covered entities should be specific in the terms of their baas and what phi maybe used and for what purpose, by both the business associate and any additional contracting agents. 231 these specifications should include the particular purposes for which phi may be de-identified. second, baas should expressly prohibit de-identification if any purpose of the deidentification is to sell the de-identified data to one or more third parties for direct or indirect remuneration. this prohibition builds on existing hipaa regulations to stop the further flow of de-identified data away from the covered entity with minimal additional administrative burden. the adoption of this stewardship policy will enable improvements in the healthcare delivery system because the state agency will serve as the source for de-identified claims data. although the policy limits availability of deidentified data critical to realizing health system improvements, it limits access to potential sources of the information, not access to the data itself. entities desiring this information for legitimate public purposes (i.e., health improvement and/or research activities) will have access to the data through the state's apcd. admittedly, determining what data and information will be released, and to whom, has been "the most sensitive aspect" of apcd implementation. 23 2 as in new hampshire, apcd enabling legislation should provide that, "[tlo the extent allowed by hipaa, the data shall be available as a resource for insurers, employers, providers, purchasers of health care, and state agencies to continuously review health care utilization, expenditures, and performance."233 the authorized state agency must then establish regulations234 that take care to ensure that data access and release policies permit the many beneficial uses of apcd data. in this way, data stewardship will protect individual privacy from the risk of re-identification without inhibiting the legitimate use of de-identified health information. 231 see id at 7. 232 love et al., supra note 19, at 10. 233 n.h. rev. stat. ann. § 420-g:11-a (2012). 234 love et al., supra note 19, at 10. 696 vol. 10:2 health care transparency iv. strengths & limitations the proposal presented in this paper is subject to two primary limitations, related to information technology and financial sustainability. first, the implementation of apcds requires states to resolve numerous technical challenges related to the development of large-scale information systems. 235 typically, data aggregation is challenging because of the lack of a standardized format across provider and/or organizational information systems.236 this factor may be less of a barrier to the development of apcds because the claims have all been developed for billing purposes. other issues that will need to be addressed include the varying capacity of payer information systems to report the data and problematic data fields like the national provider identifier. 237 accurately identifying providers has been a major challenge for states with apcds.238 mapping the national provider identifier to other data elements, such as state license number or physician name, can be difficult and expensive. 239 moreover, states need to be cognizant of the administrative burden on national health plans as more states implement apcds.240 efforts to establish uniform reporting specifications across states would reduce this administrative burden as well as improve the comparability of data from state to state.241 securing adequate funding to sustain apcds will also be a challenge for many states. like all information systems, start-up and maintenance costs are significant. 242 for 235 id. at 7. 236 steven waldren, large health database aggregation, in clinical data as the basic staple of health learning: creating and protecting a public good 122, 124 (claudia grossmann et al., eds., national academies press 2010), available at http://www.nap.edul openbook.php?recordid= 122 12&page= 122. 237 love et al., supra note 19, at 7. 238 id. at 12. 239 id 240 id. at 11. 241 [d 242 love et al., supra note 57, at 9. 6972013 indiana health law review example, vermont estimated that implementing its apcd would cost approximately $500,000 in 2009. utah's apcd was appropriated $625,000 in 2008, and annual expenses are estimated at $1 million. however, unlike other state information systems, apcds are typically are not supported through federal funding.243 where apcds have been established through legislation, funding often comes from general state funds or mandatory fees from providers and insurers. 244 in addition, it should be noted that many states are planning to rely on funding from data product sales.2 4 5 while not all data sales would be discouraged under the proposal presented here, greater scrutiny may be applied, which could limit data sales as a potential source of revenue. funding is a crucial issue, as the inability to pay for the costs of collecting and storing the claims data has prevented at least one state from following through with apcd legislative authority.246 at the same time, apcds have the potential to yield substantial value for the health care system through cdhc initiatives. while out-of-pocket costs for primary care physicians tend to be similar among insured individuals, 247 these physicians are often patients' initial points of entry into the health care system, 248 and their referral behaviors may have a significant impact on health care costs across time. cdhc initiatives would benefit from access to robust, longitudinal information which enable more meaningful distinctions regarding physician performance than simple price information would permit. health care transparency initiatives could be more effective overall when information is used to identify an efficient primary care provider or a delivery system that patients can use on a regular basis, rather than the present focus on 'a la carte' shopping for individual services.249 while it may never be possible to 243 id. 244 id. 245 id. 246 government accountability office, supra note 15, at 27 (describing florida's experience). 247 tynan, supra note 13, at 4. 248 madison, supra note 37, at 251. 249 ginsburg, supra note 1, at w215. 698 vol. 10:2 2013 health care transparency 699 eliminate the risk for re-identification generated by cdhc initiatives, negative externalities can be reduced through state action to incentivize data stewardship while simultaneously promoting improved transparency and accountability in the health care system. microsoft word final for lulu vol. 14 issue 1 final incorporating lawyers on the team to promote health and health equity health care disparities begin to get the attention of the federal government lawyers not seen on the health team a. progress on the iom’s recommendations to address health disparities b. shift in mindset: the socioeconomic determinants of health. lack of progress in eliminating health disparities institutional and structural barriers to reducing health disparities health (and health equity) in all policies promising directions for legal interventions to promote health and health equity professional and graduate education for the future progress within the health professions next steps: incorporating the legal profession disclosure: the future of health law education http://doi.org/10.18060/3911.0029 the lawyerization of medicine health professionals for a new century: transforming education to strengthen health systems in an interdependent world see also primary care and public health: exploring integration to improve population health primary care https://doi.org/10.1215/03616878-26-5-1179 https://doi.org/10.1016/s0140-6736(10)61854-5 a. health care disparities begin to get the attention of the federal government thirty years later, the “heckler report” continues to influence efforts to improve minority health supra id. id. id. id. id. figure 1. life expectancy at birth, according to race and sex: united states, 1950 – 1983.11 id. id. id. id id id. id. id. id see infra id. id. id. id. id. the id. , supra id. id. section 1557 of the affordable care act: civil rights, health reform, race, and equity b. lawyers not seen on the health care or public health teams see supra allies not adversaries: teaching collaboration to the next generation of doctors and lawyers to address social inequality ee public health law program: about us see see see infra help receives outstanding mlp award, see the health law partnership: a medical-legal partnership strategically designed to provide a coordinated approach to public health legal services, education, advocacy, evaluation, research, and scholarship https://doi.org/10.1080/01947648.2014.884892 see also health law partnership (help) , ebony progress on the iom’s recommendations to address health care disparities see generally about david satcher the 10 biggest killers of blacks postscript see spotlight: examining the impact of law and policy on health outcomes see supra the affordable care act and beyond: opportunities for advancing health equity and social justice evidence, social psychology, and health care: health injustice and justice in health: the role of law and public policy in generating, perpetuating, and responding to racial and ethnic health disparities before and after the affordable care act less talk, more action: accelerating innovative strategies to eliminate racial and ethnic disparities supra about the office of minority health see office of minority health resource center offices of minority health at hhs: hhs office of minority health and establishment of federal offices of minority health about nimhd hhs agency offices of minority health center for quality improvement and patient safety (cquips) see also national healthcare quality & disparities reports see offices of minority health at hhs healthy people 2020 see priority populations about cdc’s office of minority health & health equity (“omhhe”) see offices of minority health at hhs supra about cms office of minority health minority health office of health equity behavioral health equity, state offices of minority health and related state information healthy people 2020 framework: the vision, mission, and goals of healthy people 2020 national stakeholder strategy for achieving health equity npa stakeholder strategy hhs disparities action plan to reduce racial and ethnic health disparities: a nation free of disparities in health and health care hhs disparities action plan see also hhs action plan to reduce racial and ethnic health disparities: implementation progress report 2011-2014 hhs disparities action plan progress report npa national stakeholder strategy supra hhs disparities action plan supra healthy people 2020 grants and grant programs how we work: building a culture of health see also what shapes health? closing socioeconomic gaps in health see, e.g. health equity see also disparities policy see also research network on ses & health see also racial equity unnatural causes: is inequality making us sick innovations in health equity and health philanthropy equity of care: toolkit for eliminating health care disparities unnatural causes: is inequality making us sick? supra supra supra hhs disparities action plan supra npa stakeholder strategy supra health disparities: state laws see generally shift in mindset: the socioeconomic determinants of health health disparities: state laws supra see also review of state legislative approaches to eliminating racial and ethnic health disparities, 2002–2011 beyond health care—socioeconomic status and health the association between income and life expectancy in the united states, 2001-2014 https://doi.org/10.2105/ajph.2015.302590 https://doi.org/10.1056/nejme0802773 https://doi.org/10.1001/jama.2016.4226 our approach in pursuit of health equity: comparing u.s. and eu approaches to eliminating disparities the relative contribution of multiple determinants to health outcomes the case for more active policy attention to health promotion actual causes of death in the united states the good life: working together to promote opportunity and improve population health and well-being differences in life expectancy due to race and educational differences are widening, and many may not catch up ee also the social determinants of health: it’s time to consider the causes of the causes https://doi.org/10.1377/hlthaff.21.2.78 https://doi.org/10.1001/jama.1993.03510180077038 https://doi.org/10.1001/jama.2016.4263 https://doi.org/10.1377/hlthaff.2011.0746 https://doi.org/10.1177/00333549141291s206 supra see, e.g. all figure 2. race and ethnicity-adjusted life expectancy for 40-year-olds by household income percentile, 2001–2014.82 supra id. supra . on death and money: history, facts, and explanations https://doi.org/10.1001/jama.2016.4072 id. see also measuring recent apparent declines in longevity: the role of increasing educational attainment supra contribution of major diseases to disparities in mortality understanding the relationship between education and health: a review of the evidence and an examination of community perspectives in educational attainment and adult health: under what conditions is the association causal https://doi.org/10.1377/hlthaff.2015.0481 https://doi.org/10.1056/nejmsa012979 https://doi.org/10.1016/j.socscimed.2014.12.029 figure 3. socioeconomic gradients in poor/fair health among adults aged 25 to 74 years within racial/ethnic groups in the u.s., 2008-2010.88 supra see also trends and group differences in the association between educational attainment and u.s. adult mortality: implications for understanding education’s causal influence supra social determinants of health and crime in post-katrina orleans parish in maps to #closehealthgaps; life expectancy map: atlanta https://doi.org/10.1016/j.socscimed.2014.11.024 where health disparities begin: the role of social and economic determinants–and why current policies may make matters worse see also supra 2016 county health rankings: key findings report supra addressing health disparities is a placebased issue https://doi.org/10.1377/hlthaff.2011.0685 https://doi.org/10.2105/ajph.2016.303077 healthy people 2020 lack of progress on eliminating health disparities supra see also effects of proximity to supermarkets on a randomized trial studying interventions for obesity disparities and access to healthy food in the united states: a review of food deserts literature supra see also air pollution and early deaths in the united states, part i: quantifying the impact of major sectors in 2005 zoning, equity, and public health social determinants of health see supra https://doi.org/10.2105/ajph.2015.302986 https://doi.org/10.1016/j.healthplace.2010.04.013 https://doi.org/10.1016/j.atmosenv.2013.05.081 https://doi.org/10.2105/ajph.91.7.1033 remarks to the committee on community based solutions to promote health equity in the united states hhs disparities action plan supra see also progress toward the healthy people 2010 goals and objectives hhs disparities action plan supra hhs disparities action plan progress report supra healthy people 2010: final review supra id. ee also supra https://doi.org/10.1146/annurev.publhealth.012809.103613 id. supra ee also id. id. minor health month: making progress on health disparities supra supra id. institutional and structural barriers to reducing health disparities [i]nstitutionalized racism supra see generally sick and tired of being sick and tired: putting an end to separate and unequal health care in the united states 50 years after the civil rights act of 1964 supra id. see also health inequalities by class and race in the us: what can we learn from the patterns?, https://doi.org/10.1016/j.socscimed.2011.12.009 levels of racism: a theoretic framework and a gardener’s tale toward a structural theory of implicit racial and ethnic bias in health care understanding racial-ethnic disparities in health: sociological contributions see also separate and unequal: racial segregation and disparities across u.s. nursing homes the toxic trap: how a disastrous chain of events corroded flint’s water system elevated blood lead levels in children associated with the flint drinking water crisis: a spatial analysis of risk and public health response https://doi.org/10.2105/ajph.90.8.1212 https://doi.org/10.1177/0022146510383838 https://doi.org/10.1377/hlthaff.26.5.1448 https://doi.org/10.2105/ajph.2015.303003 health (and health equity) in all policies supra class–the ignored determinant of the nation’s health ee also educational status and active life expectancy among older blacks and whites see supra health disparities by race and class: why both matter ee also supra https://doi.org/10.1056/nejmsb040329 https://doi.org/10.1056/nejm199307083290208 https://doi.org/10.1377/hlthaff.24.2.343 supra ee also health in all policies: a guide for state and local governments supra supra ee also health impact project supra id. ee also ee also supra see also supra see generally obesity and public policy: a roadmap for reform ee also supra combating obesity through the built environment: is there a clear path to success? https://doi.org/10.1111/j.1748-720x.2011.00608.x supra supra supra health impact assessment policy approaches to advancing health equity supra ee also supra supra id. https://doi.org/10.1097/phh.0000000000000365 a. promising directions for legal interventions to promote health and health equity ee also supra ee social conditions, health equity, and human rights see supra supra see supra id. investing in place ee generally supra racial and ethnic approaches to community health reach 2014 our commitment to eliminate racial and ethnic health disparities the individual mandate: implications for public health law see legal innovations to advance a culture of health https://doi.org/10.1111/j.1748-720x.2011.00610.x http://doi.org/10.1111/jlme.12328 supra id. ee generally paying people to act in their own interests: incentives versus rationalization in public health e.g., see also paying people to act in their own interests: incentives versus rationalization in public health ee also “i did it for the money”: incentives, rationalizations and health see generally medical-legal partnerships: collaborating to transform healthcare for vulnerable patients https://doi.org/10.1093/phe/phu035 https://doi.org/10.1093/phe/phu034 supra did you know?, why compton?, id. holding schools responsible for addressing childhood trauma, , taking a broader view of health: with less need for charity care, hospitals focus on community health improvement ee also can hospitals help create healthy neighborhoods hospital community benefit: how partnerships can support healthy communities id see also id id id see generally id id id outcomes motives id https://doi.org/10.1001/jama.2015.16749 b. professional and graduate education for the future 1. progress within the health professions id see, e.g., see also supra ee also infra supra see see generally national standards for culturally and linguistically appropriate services in healthcare: final report see generally national culturally and linguistically appropriate services standards think cultural health: clas legislation map supra ee also supra a framework for educating health professionals to address the social determinants of health, 15 http://www.nationalacademies.org id id id. see supra supra 2. next steps: incorporating the legal profession the future of public health law education journal of law, medicine & ethics supra see transforming the future of public health law education through a faculty fellowship program innovation in higher education: lessons learned from creating a faculty fellowship program see best practices for teaching public health law: two online resource libraries http://doi.org/10.1177/1073110516644215 http://doi.org/10.1177/1073110516644239 http://doi.org/10.1177/1073110516644237 tearing down the silos: an interdisciplinary, practicebased approach to graduate school education combining accreditation and education: an interdisciplinary public health law course building a public health law and policy curriculum to promote skills and community engagement expanding interdisciplinary learning opportunities on a shoestring through a medical-legal partnership teaching prevention: an interdisciplinary approach to improving population health through law and policy seminar in public health law and policy in an interprofessional setting: preparing practitioners for collaborative practice at the macro level http://doi.org/10.1177/1073110516644232 http://doi.org/10.1177/1073110516644217 http://doi.org/10.1177/1073110516644224 http://doi.org/10.1177/1073110516644228 http://doi.org/10.1177/1073110516644230 http://doi.org/10.1177/1073110516644229 teaching population health outcomes research, advocacy, and the population health perspective in public health law, public health law as a way to explore and develop professional identity, promoting diversity in public health law through online education, educating the new public health law professional the importance of including the deans reflections on mentoring http://doi.org/10.1177/1073110516644226 http://doi.org/10.1177/1073110516644227 http://doi.org/10.1177/1073110516644223 http://doi.org/10.1177/1073110516644225 http://doi.org/10.1177/1073110516644234 http://doi.org/10.1177/1073110516644233 polishing the apple: a holistic approach to developing public health law educators as leaders of change supra supra http://doi.org/10.1177/1073110516644235 id. black americans see gains in life expectancy white americans are dying younger as drug and alcohol abuse rises see also rising morbidity and mortality in midlife among white and non-hispanic americans in the 21st century http://doi.org/10.1073/pnas.1518393112 the future of public health law education ihlr vol 14 iss. 2.pdf http://doi.org/10.18060/3911.0038 https://doi.org/10.1056/nejmp1507252 https://doi.org/10.3109/10826089509104419 https://doi.org/10.2105/ajph.2005.065961 https://doi.org/10.2105/ajph.2011.300595 https://doi.org/10.1111/j.1360-0443.2008.02465.x https://doi.org/10.1016/j.drugpo.2007.09.002 https://doi.org/10.1007/s10461-015-1143-6 ip ads, iphones, androids, and smartphones: fda regulation of mobile phone applications as medical devices alex krouse* i. introduction ............................................................................... 731 ii. background ................................................................................ 733 a. what are mobile applications? ............................................... 733 b. mobile applications: a brief history ...................................... 733 c. mobile application uses and complexities ............................. 735 iii. mobile health ............................................................................ 737 a. mobile health industry ............................................................ 737 iv. mobile health applications .................................................... 741 a. introduction to mobile health applications ............................ 741 b. informational mobile health applications .............................. 741 c. diagnosing mobile health applications .................................. 743 v. regulation of medical devices .............................................. 7 45 a. medical device definition by fda .......................................... 745 b. classes of medical devices under the fda ............................ 746 c. component vs. accessory regulation ...................................... 748 vi. are mobile applications medical devices? ......................... 749 a. fda regulation ofsoftware .................................................... 749 b. bearing the burden of regulation ........................................... 752 c. current fda approved mobile applications .......................... 753 vii. regulatory solutions for mobile health applications .. 755 a. defining non-regulated mobile health applications ............. 756 b. defining regulated mobile health applications ..................... 757 c. current fda position on medical device review .................. 757 viii. fast track solution for mobile health .............................. 760 a. european model summary ...................................................... 761 b. benefits of separate regulatory scheme ................................. 762 c. a test model for mobile health applications ......................... 762 ix. conclusion .................................................................................. 764 i. introduction a person diagnosed with a form of arrhythmia, or abnormal electrical activity in the heart, decides to download the application instant heart rate for their mobile smartphone. the person, knowing they have this condition, *alex krouse, j.d., 2012, indiana university robert h. mckinney school of law; m.h.a., 2012, indiana university school of medicine; b.a., 2008, depauw university. 732 indiana health law review [vol. 9:2 would like to monitor their heart rate to make sure nothing is wrong. after discovering he or she can use their phone to check his or her heart rate, the person is thrilled. however, after using the application for a few weeks the person notices considerable differences between the phone application and other heart rate monitors. luckily, this person noticed these differences because it is likely that without accurate readings, the person could put his or herself at risk of suffering a heart attack. to date, the instant heart rate application has over 4 million downloads and has been rated by over 60,000.1 mobile phone applications, or mobile applications,2 such as the one described above are becoming more prevalent every day. in particular, mo­ bile health applications are seeing an increasing usage among smartphone3 users. people who carry smartphones can access information ranging from the local news to vital health and treatment facts. in addition, these applica­ tions do much more than simply allow the person to read information. for example, the instant heart rate application for android phones tells the user to "place the tip of your finger on the camera lens so it completely co­ vers the lens. hold your phone steady.',.. then, your current heart rate will be shown on the display. 5 a user simply needs to download the application, and they will have a tool to monitor their heart rate. this might appear to be a minor advancement, but it highlights that mobile phone users are now beginning to rely on their smartphones for health purposes. this note addresses the major crossroads of regulation that mobile health applications are currently facing from the food and drug admin­ istration ("fda"). first, the mobile health industry is growing at an im­ pressive rate, placing useful health applications at the fingertips of users daily.6 second, the fda has begun regulating mobile health applications as l. instant heart rate, appbrain, http://www.appbrain.com/app/instant-heart­ rate/si.modula.android.instantheartrate (last visited jan. 16, 2011). 2. a mobile phone application is "a term used to describe internet applications that run on smartphones and other mobile devices. mobile applications usually help users by connecting them to internet services more commonly accessed on desktop or notebook com­ puters, or help them by making it easier to use the internet on their portable devices." mo­ bile application, webopedia, http:/ /www.webopedia.comfi'ermim/mobile _application. html (last visited feb. 28, 2012). 3. smartphone is defined as: "a cellular telephone with built-in applications and internet access. smartphones provide digital voice service as well as text messaging, e-mail, web browsing, still and video cameras, mp3 player, video viewing and often video calling. in addition to their built-in functions, smartphones can run myriad applications, turning the once single-minded cellphone into a mobile computer." definition of smartphone, pcmao.com, http://www.pcmag.com/encyclopedia_term/0,2542,t=smartphone&i=51537, oo.asp (last visited feb. 28, 2012). 4. appbrain, supra note l. 5. ld 6. see, e.g., chris gullo, health apps already a bigger market than remote moni­ toring, mobihealthnews (jan. 6, 2012), http://mobihealthnews.coplf15646/health-apps­ already-a-bigger-market-than-remote-monitoring/. 20 12] fda regulations of mobile phone apps as medical devices 733 medical devices.7 however, current fda regulations for medical devices lack clarity regarding this new technology. finally, due to the lack of clari­ ty, the fda must look to improve the regulatory structure to maintain a balance between product safety and innovation for mobile health applica­ tions. the increasing regularity ofmobile device and mobile application use throughout society demonstrates the pressing importance of this issue. by implementing a separate regulatory scheme for mobile health applica­ tions, the fda can address these concerns. ii. background a. what are mobile applications? a mobile application is· a piece of software that is contained within a phone for a particular purpose or use. the purpose of mobile applications varies from providing information to actual interaction with the user. es~ sentially, the main goal for all mobile applications is to provide a service that can be used on cell phones rather than an actual computer. although mobile applications are complex and serve various purposes, all share the ability of allowing the user to access information through this mobile device or cell phone. 8 b. mobile applications: a brief history mobile applications are a recent phenomenon, however not quite as recent as one may think. although the mobile application industry has seen an increase since the advent of smartphones, mobile applications for mobile devices were developed as early as 1992.9 examples of some early applica­ tions developed include calendars, lists, and other task oriented applica­ tions. generally, these applications allowed users to keep track of information with their mobile phones. this increased mobility of infor­ mation allowed users to save time, money, and confusion by providing ac­ cess to the information at all times. however, the true potential of mobile phone applications was not evident until the recently. due to technological innovations, mobile devices10 are now able to 7. draft guidance for industry and food and drug administration staffmobile medical applications, u.s. food & drug admin. (july 21, 2011), http://www.fda.gov/ medicaldevices/deviceregulationandguidance/guidancedocumentslucm263280.htm. 8. webopedia, supra note 2. 9. smartphone: access or excess, arlingtonian.com (oct. 6, 2010), http://www.arlingtonian.com/archives/2628; see also john schneidawind, poindexter putting finger on pc bugs, usa today, nov. 23, 1992, at 2b. . 10. a mobile device is defined as: a .computing device that is typically smaller than a computer, however still has the capability to contain a keyboard or touchscreen for user in­ put. examples include the iphone, ipad, blackberry devices, android devices; and tablet 734 indiana health law review [vol. 9:2 view websites and data through the various cellular networks. these inno­ vations allow developers of software to build programs specified for mobile devices. initially, the need for various applications was quite low. the smartphone market only truly began in 1997 with the ericsson gs88.11 in addition, the widely popular blackberry phone did not attain widespread popularity until the early 21st century. 12 the true advent of mobile applica­ tions occurred shortly after apple inc. developed the iphone, which· was released in the summer of2007.13 that summer, apple stated that the iph­ one could support applications built by third parties.14 this development led to the use of online application stores which further enabled users to use mobile applications on their cellular devices. the increased use of mobile applications is the result of an increase in mobile device use and the development of online application stores. the online application stores create an environment for third party develo~ to sell their applications which can then be used on mobile devices that use the appropriate operating system. 15 these stores have now become common­ place across mobile phone networks. they have been created by apple for the iphone, blackberry for blackberry devices, and android for mobile phones using the android operating system. , one of the most popular online stores is the apple app store. .with the development of the iphone, the application store allowed the masses to develop applications. currently, over 350,000 applications are available through the apple app store. 16 another. influential online application store is called the android market. this online store is developed on the google operating system known as android, where the applications are compatible with android operating mobile devices. currently the store contains over 100,000 applications.17 finally, the blackberry app world is another store online designed for application sales. the blackberry app world contained computers. see priya viswanatban, what is a mobile device?, about.com, http://mobiledevices.about.com/odlgloss8jy/g/what-ls-a-mobile-device.htm (last visited mar. 10, 2012). 11. history, stockholm smartphone, http://www.stockholmsmartphone.org/history/ (last visited feb. 28, 2012). . 12. the history of the blackberry, bbgeek.s (apr. 15, 2008), http://www.bbgeeks. comlblackberry-guides/the-history-of-the-b1ackberry-88296/. · · 13. iphone 2g history, lphonehlstory, http://www.iphonehistory.com/iphone-2g/ (last visited feb. 28, 2012). 14. press release, apple inc., iphone to support third-party web 2.0 applications (jan. 11, 2007), http://www.apple.com/prllibrary/2007/06/11iphone.html. 15. operating system is defined as: "software that controls the execution of computer programs and may provide various services." definition of operating system, wordnet search-3.1, http://wordnetweb.princeton.edu/perllwebwn (last visited mar. 10, 2012) (type "operating system" in box labeled "word to search for;" then click "search wordnet"). 16. christian zibreg, when will android people pay for quality?, 9to5mac (mar. 10, 2011, 12:20 pm), http://www.9to5mac.com/55273/when-will-android-peop1e-pay-for­ quality/. 17. edwin kee, google android hits 100,000 application milestone on android mar.­ ket, ubergizmo (oct. 25, 2010, 9:41 pm), http://www.ubergizmo.comt15/archives/2010/ 1 0/google _android_ hits_l 00000 _application_ milestone_ on_ android_ market.html~ 2012) fda regulations of mobile phone apps as medical devices 735 over 10,000 applications as of september 2010.18 all of these application stores have allowed users the ultimate access to data through their mobile devices. the most important innovation in the development of the mobile ap­ plication industry is that the applications can be used on multiple devices beyond cellular telephones. for example, an application downloaded off of the apple app store likely works on not only the iphone but also the ipad tablet and the itouch mp3 player. this is due to the fact that the applica­ tions are built on the specific operating platforms that are used by individu­ al mobile devices. this also occurs with both android and blackberry devices. the latter two companies have their operating systems on tablets similar to the ipad, which is important because like apple inc. these appli­ cations are not only able to be used on cellular devices but also other mo­ bile devices that are not used as cell phones. the transferability of these applications makes regulating mobile applications a growing problem. c. mobile application uses and complexities mobile phone applications have created a new industry within the world. for the first time, consumers are able to use their phones as more than a telephone. also,· because these applications can be used across mul­ tiple devices, the technology industry has developed mobile phones that are similar to· computers and computers that are similar to mobile phones. a prime example of this is the ipad. the overall purpose of these applications cannot be easily defined; however, it is necessary to understand the true complexities. some simply allow the user to read information, while others almost perform a task for the user that could not be otherwise done without the application. · the most effective way to understand mobile applications is through examples. first, there are some common mobile applications that allow a user to use the internet easier or to help read information from a mobile de­ vice. a prime example is the mobile browser skyfire. this application allows users to download the software onto their device and read webpages similarly to the way one would read or use a website on their computer. 19 because it is tough to read or view an entire webpage from a mobile phone, skyfire is an application that makes this transition easier for the user by 18. donald melanson, blackberry app world crosses the 10,000 mark, engadget (sept. 8, 2010, 10:53 pm), http://www.engadget.com/2010/09/08/blackbeny-app-world­ crosses-the-1 0-000-app-mark/. 19. skyfire mobile browser improves the mobile internet experience by allowing users to read webpages in a similar format to computers. not all webpages transition easily to smaller screens used on mobile devices, and this application makes this transition to smaller screens. see cloud solutions for mobility, skyfire.com, http://www.skyfire.com/ (last vis­ ited feb. 20, 2012). 736 indiana health law review [vol. 9:2 running the webpage on a server and relaying it to the end user.20 however, applications such as skyfrre are just the beginning. considering the number of applications available, this is not surprising. another example is the ap­ plication google maps, developed by google inc., which allows users to obtain directions or even locate their specific position within the map.21 the user, if other friends have the same application, can even see the loca­ tion of a friend within the map and get directions specifically to the location ofthe other person's device.22 mobile applications are also used for different purposes beyond loca­ tion· and making one's device more efficient for internet use, such as the shop savvy application, which allows the user to download the application for the purpose of shopping. 23 the application gives the user the ability to scan barcodes of products in stores·and compare prices to other stores in the area or online.24 obviously, without the application shoppers would need to scan the barcode at the register within the store to find the price. this is one example of a common application, offering a complex yet new way to shop and save time. thus far, the applications discussed have involved common applica­ tions . that are geared towards the general public. however, there are a growing number of applications geared toward specific industries and pro­ fessionals, including medicine. these types of applications highlight the complexities involved in developing mobile applications. industry specific applications are not reaching out to the general pub­ lic but are specifying their application for the needs of enterprises or corpo­ rations. 25 this category would also include applications for individuals within specific professions or jobs. these types of applications are com­ plex in a different way: they offer professional knowledge to professionals in a given field if downloaded and used. an industry specific application includes the concrete calc, which allows users to find the cubic yards of 20. id 21. see google maps for mobile, gooole mobile. http://www.google.com/mobilel maps/ (last visited feb. 20, 2012). 22. see google latitude, gooole mobile, http://www.google.com/mobile/latitudel (last visited feb. 20, 2012). 23. see shop ~ (barcode scanner and qr code reader), itunes preview, http://itunes.apple.com/us/app/shop-savvy-barcode-scanner/id338828953?mt=8 (last visited feb. 20, 2012). 24. id. 25. industry specific applications are currently being built for corporations to make their own internal processes easier. one example is a company called rehabcare, which uses mobile applications to facilitate its therapy services. nancy gohring, cloud services spur mobile enterprise apps, pcworid, http://www.pcworld.com/iuticle/209072/ cloud_services_spur_mobile_enterprise_apps.html (last visited feb. 20, 2012). "the thera­ pists use the app to view their schedules, look up patient information and start and stop their time clocks. by the end of the year, rehabcare hopes to have deployed 8,000 ipod touches so that therapists can use the application." !d. 2012] fda regulations of mobile phone apps as medical devices 737 concrete needed for a specific job.26 although it appears to be a basic cal­ culator, the application page explains that it is "good for building, construc­ tion or diy.'m this description highlights that the application developer intends this calculator to be used for building on a novice to expert level. another example of a more complex industry specific mobile applica­ tion is the cadtouch r2 .. this application "allows users to draw floorplans, land surfaces (and calculate area and perimeter), facades, [and] mechanical or structural parts.'.28 applications such as these are geared towards con­ struction managers, engineers, and other builders. obviously the applica­ tion provides an easier method to figure out complex problems with construction. finally, ihydrate, developed by mobile sports inc., is geared towards coaches or even parents of athletes.29 the application allows the user to see the current temperature at their location, displays the risk of heat illness, and allows the user to schedule hydration reminders.30 by understanding some examples of industry specific applications, it becomes easier to see what developers are trying to do with mobile applica­ tions for devices. developers are attempting to bring the. resources that consumers have at a computer to handheld devices at all times, which has many consequences for the health care industry. some applications can be developed strictly for professionals, while others can be easily accessed by the general public. because mobile applications are being developed for health care providers every day, numerous issues regarding to regulation are created. these applications might be solely informational, but many are also geared towards diagnosing and treating patients, which highlights the ultimate risk. 31 lli. mobile heal1h a. mobile health industry mhealth, also known as mobile health, is a term used for "the delivery 26. see concrete calc, itunbs preview, http://itunes.apple.com/us/applconcrete­ calculator/id317133083?mt=8 (last visited feb. 20, 2012). 27. ld. 28. houston neal, the best construction management apps for the iphone and ipad, software advice, http:/lwww.softwareadvice.com/articles/construction/the-best-constr uction-management-apps-for-the-iphone-and-ipad-1 082510/ (last visited feb. 20, 2012). 29. iphone app helps keep athletes well hydrated, avoid heat-related illness, momsteam, http://www.momsteam.com/bealth-safety/ibydrate-application-helps-athletes­ stay-hydrated (last visited feb. 20, 2012). 30. ld. 31. resolutionmd mobile allows doctors to send images to other mobile devices such as the iphone or android smartphone for viewing and diagnostic purposes. see cindy wax­ er, how mayo clinic doctors use smartphones to diagnose patients, itworid (oct. 28, 2010, 8:43 pm), http://www.itworld.com/software/125744/bow-mayo-clinic-doctors-use­ smartpbones-diagnose-patients. 738 indiana health law review [vol. 9:2 ofhealthcare services via mobile communication devices."32 there are oth­ er definitions, but, overall, mhealth is a term used for the practice of clini­ cal medicine and public health supported by mobile devices.33 mobile health applications play a pivotal role in the mhealth movement because mhealth relies on providers' use of these applications when servicing pa­ tients. this creates a dilemma that has not been seen since the development of computers. providers have been using software to aid their medical deci­ sions for some time, but now providers can also use their mobile devices to help them make actual diagnoses. in addition, m.health is offering solutions directly to the consumer. while in developing countries this mobility is seen as a major innovation, in highly regulated countries, such as the united states, this can create problems. even though the industry is still in its in­ fancy, statistics show that mhealth is growing exponentially. the data discussed previously highlights the influence of mobile. ap­ plications as a whole; however, recent information also shows that mobile applications are transitioning into the health care industry. according to a survey by ctia and harris interactive, seventy-eight percent of the united states is interested in mobile health solutions. 34 it is important to under­ stand the general industry and movement in order to understand how im­ portant regulation of this industry may· be. to highlight this, twenty-three percent of the responders believed that mobile health could replace doctor visits altogether.35 if consumers will use mobile health applications in lieu of medical professional visits, the need for regulation is apparent. this need is ultimately in a grey area. which needs to be addressed. the grey area that has developed creates unprecedented consumer and professional access to mobile applications, some of which should be used strictly by professionals. access to wireless health solutions in the united states is' impressive. currently, almost ninety percent of the u.s. popula. tion has a mobile phone. 36 in addition, close to nineteen percent of people have smartphones that are capable of using the most current mobile health applications.37 obviously consumers have access to mobile applications; but, medical professionals themselves are extremely important to delivering care through technology. this creates a dilemma between increasing access to mobile health solutions and the risk of consumers using these applica­ tions for diagnosing and treatment. providers themselves are contributing to this dilemma because there 32. carol torgan, the mllealth summit: local&: global converge, kinetics (nov. 6, 2009), http://www.caroltorgan.com/mhealth-summit/. 33. see id. 34. mobihealthnews, wireless health: state of the industry 2009 year end report l, 2 (2009), available at http:l/mobihealthnews.com/wp-content/reports/2009 stateofthelndustry.pdf. 35. /d. at 2-3. 36. /d. at4. 37. /d. at5. 20 12] fda regulations of mobile phone apps as medical devices 739 are definite cost, time and effort benefits created through this new mobile health industry. "manhattan research found that 64 percent of physicians use a smartphone today. that's 20 percent more physicians than in 2008. by 2013, 81 percent of physicians will use smartphones. "38 while the in­ dustry has not yet fully adjusted to the influx of these applications, the fu­ ture statistics highlight that mobile health capabilities will increase exponentially. physicians and nurses will be able to make decisions in a faster and more efficient manner. nonetheless, the costs savings possible show the dilemma regulatory agencies have regarding mobile applications. during a time when the united states spends 16.7% of its gdp on health care, the use of mobile health has the potential to be a tool in reduc­ ing cost and promoting efficiencies in health care delivery.39 in 1990, the united states spent $714 billion on health care, but by 2008 the united states had spent over $2.3 trillion on health care.40 these startling statistics demonstrate the need for more effective use of technology to promote effi­ ciencies and cost savings. as an example of the cost saving potential, veri­ zon wireless estimates that their mobile broadband solutions saved nearly $6.9 billion through improved productivity, and "[t]hat figure is expected to increase to $27.2 billion by 2016!"'1 although this is one example, the pos­ sibilities resulting from increased technological access to hospitals and medical providers are endless. the overall mobile health application industry has been expanding be­ cause of these catalysts. according to mobihealthnews: as of march 2010, there were 6000 mobile health applications available online with nearly thirty percent intended for use by healthcare professionals. 42 that means almost 2000 applications are being directly marketed towards medical pro­ fessionals.43 some of these applications cost as much as 299 dollars.44 with numerous options in the industry's infancy, medical providers already have unprecedented access to mobile applications. despite the mobile health application industry being in its infancy, medical providers have un­ precedented access to mobile applications. not only are there many mobile health applications currently available on the online stores, their numbers are increasing at a rapid pace. as of september 2010, mobile health applications on the apple appstore have 38. id. 39. u.s. health care costs, kaiseredu.org, http://www.kaiseredu.org/lssuemodules!us-health-care-costs/background-briet:aspx (last visited oct. 31, 20 l 0). 40. id. 41. mobihealthnews, supra note 38; at 5. 42. brian dolan, 3 million downloads for android health apps, mob:ihealthnews (mar. 11, 2010), http:/lmobihealthnews.com/6908/3-million-downloads-for-android-health­ apps/. 43. ld. 44. id. 740 indiana health law review [vol. 9:2 grown by 66.6% within a 7-month timeframe.45 during the same period, the number of mobile health applications available on the android market grew by 156.6% and by 141.4% in the blackberry app world.46 recognizing the increasing amount of mobile health applications available for download, it is necessary to analyze whether physicians are actually us~ng applications for medical purposes. a report conducted by sdi found that ninety-five percent of the physicians who used mobile de­ vices or smartphones utilize mobile health applications to access medical information.47 because physicians are already using different forms of ap. plications, the increase of applications will only increase their ability to uti­ lize mobile application technology. another factor increasing the prevalence of mobile health applications has been the actions of large corporations targeting health care providers for this new technology, highlighting. the need for more regulation of these mo­ bile health applications. for example, at&t recently created an entire di­ vision devoted toward targeting the health care industry.48 one of their initial offerings is an "'intelligent pill-bottle cap[]"' that sends a text mes­ sage to caregivers when it is not opened on a daily basis.49 although this is not. an application itself developed by a third party, it does show that corpo­ rations are recognizing the strong need for mobile health solutions. other large companies have also invested heavily in mobile health technology. v erizon wireless recently announced a· deal with bl healthcare for health applications that will work on bl's wireless devices. 5° additionally, verizon has promoted applications for home health care workers and mobile video consultations. 51 even more interesting is apple inc.'s showcas.ing of medical applications to be used with their iphone to physicians during workshops at its stores. 52 additionally, apple has a des­ ignated space for medicine on their website which includes many of their technologies. 53 . these examples emphasize the need for further regulation because the 45. dolan, supra note 45. 46. !d. 47. sdi reports: nearly a third of physicians use handheld and smartphone devic­ es to access medical information, prweb (mar. 4, 2010), http://www.prweb.com/releases/ sdi/socialmediastudy/prweb3681704.htm. . 48. peter svensson, at&t sets up division to target health care, wireless week (nov. 5, 201 0), http:/lwww. wirelessweek.com/news/20 1 0/11/policy-and-industry-a 'it­ division-target-healthcarel. 49. !d. 50. brian dolan, mobile health 20/20: verizon, google, glowcap, mobihealthnews (aug. 11, 2010). http:l/mobihealthnews.com/8605/mobile-health-2020verizon-google-glowcap/. 51. !d. 52. dtifat husain, apple is actively recruiting health care providers at their retail stores, imedicalapps (may 6, 2010), http:llwww.imedicalapps.com/2010/05/apple­ healthcare-providerselectronic-medical-records-ipad-iphonel. 53. !d. 20 12] fda regulations of mobile phone apps as medical devices 741 industry can and will expand into every facet of medical practice. corpo­ rate movement into the arena of mobile health has spurred the development of applications, and as discussed above, some companies are even promot­ ing the use of these applications. as mentioned previously, some applica­ tions are merely informational while others are extremely complex. only by analyzing current mobile health applications is it possible to understand the dividing line of what applications should be regulated. however, a bal­ ance between innovation and regulation needs to be struck because of the extensive investment in the industry by mobile phone companies, third par­ ty developers, and medical providers. iv. mobile health appucations a. introduction to mobile health applications understanding the mobile health application industry is important in recognizing the delicate nature of these new innovations. on one hand, an entire new industry is being developed for people who have mobile devices or smartphones. yet on the other hand, mobile health applications are giv­ ing unprecedented access to health diagnosis, treatment, and decision­ making software to everyone with access. in order to fully understand the amount of regulation needed though, it is necessary to consider the types of applications offered and the level of medical intervention they provide. mobile health applications are surprisingly innovative and have truly amazing capabilities. there appear to be two main types of mobile health applications: information-based and diagnostic. when a mobile health ap­ plication acts simply as an informational source, it provides little more than a website or a book; however, as the function of an application becomes more diagnostic the need for regulation becomes more realistic. by analyz­ ing the currently developed models, a more firm dividing line can be dis­ cerned to decide what level of regulation is necessary for each individual mobile health application. b. informational mobile health applications informational applications allow the user to read, input their own data, and gather resources to make decisions. applications such as these have been used for quite some time, but they have mostly been utilized by medi­ cal professionals. one prime example of an information health application is epocrates, which is an application built for iphones, ipods, blackberrys, and androids among others. 54 epocrates software allows the user to look 54. mobile products, epocrates inc., http://www.epocrates.com/mobile (last visited mar. 3, 2012). 742 indiana health law review [vol. 9:2 up drug information, coding references, and medical dictionary terms. 55 as of 2010, epocrates had one million users, including forty percent of physi­ cians in the united states. 56 this information is used by the physician to make medical decisions based on his or her own knowledge. however, use of this application provides a reference on hand at all times. although this application is geared towards medical providers, anyone can download and use the application. with the current application explosion, informational applications are becoming more useful for the everyday user in addition to medical providers. the medscape app for the iphone or ipod touch is another application that allows the user to reference drugs, check drug interactions, find disease references, and view step by step instructions for clinical procedures.57 medscape is similar to epocrates in that its main purpose is for information rather than an actual medical procedure. nonetheless, these two examples highlight informational mobile health applications predominately targeted towards medical providers, although consumers can still easily download these products. in addition, other mobile health applications have been developed for the common consumer rather than a health care provider. an example of this type of mobile health application is the let's move it application. the let's move it mobile health application, developed by cleveland clinic wellness enterprise, is an application that allows the user to track steps tak­ en, calories burned, weight loss, and allows the user to set goals for activi­ ty. 58 this application is available for download on apple devices as well as android devices59 it provides information and feedback on the user's activ­ ity but is merely informational for the user, as it only offers a data tracking system.60 . another example of a consumer focused mobile health application is the cures a-z application. although this application is marketed toward the general consumer rather than a medical provider, the application devel­ oped by plum amazing purports to be a ''free comprehensive medicine specialist in your pocket. '.61 the actual application contains a complete list of health conditions and their treatments in order for users to manage an 55. id. 56. epocrates files to raise up to $75m in /po, s.f. bus. times {july 16, 2010), http://www.bizjournals.com/sanfrancisco/stories/2010/07/12/daily88.html. 57. medscape mobile, meoscape, http://www.medscape.com/public/iphone?src=ppc_ google&ef_id=:20101104145047:s (last visited nov. 4, 2010). 58. let's move it, itunes preview, http://itunes.apple.com/uslapp/lets-moveit/id396874560?mt=8 (last visited mar. 10, 2012). 59. /d. 60. see id 61. cures a-z, itunes preview, http://itunes.apple.com/us/app/cures-a-z/id29764 8638?mt=8 (last visited mar. 10, 2012). · 2012] fda regulations of mobile phone apps as medical devices 743 illness.62 additionally, the application can teach the user about nutrition and the benefits of living a healthy lifestyle. 63 although this application is informational, it does purport to act as a medical professional in one's pocket.64 the two previous examples demonstrate that mobile health applica­ tions once were more informational although some very noticeable grey areas existed. for example, with certain applications users can provide their own treatments. the user is given the information not just for his or her own knowledge but to actually diagnose his or her problem in hopes of finding treatment. however, obviously the information provided is similar to a website rather than an actual medical tool used for diagnosis. nonethe­ less, these forms of applications are numerous and the dividing line be­ tween an informational application, and an application for diagnosis is hardly noticeable at all times. c. diagnosing mobile health applications mobile health applications that are used in diagnosis and treatment are of the utmost concern because some allow decision processes normally handled by medical professionals to now be entirely dependent on the soft­ ware. the technology used for mobile health applications is complex and the applications normally allow the user to solve an illness or act to give the user information regarding their illness. currently, these mobile health ap­ plications are geared towards medical providers; however, there are many that everyday consumers could use for their own purposes. although the­ se applications are in their infancy, the industry has made impressive strides in developing mobile health applications that act beyond informational pur­ poses. a prime example of a diagnosing mobile health application is instant heart rate. instant heart rate is an application built for the iphone and android devices.65 the application can take the user's heart rate by allow­ ing the user to place his or her finger over the camera for ten seconds. 66 the developer explains that "it works by tracking the color changes in the light that passes through your finger" and acts "as a medical pulse oximeter but without a dedicated light source.'o67 bear in mind, the fda has drafted guidance on fda approval of pulse oximeters.68 this is an example of a 62. see id. ·63. see id. 64. /d. 65. instant heart rate, azumio, http://www.instantheartrate.com/android.jsp (last visited mar. 10, 2012). 66. /d. 67. /d. 68. see draft guidance for industry and fda staffpulse oximeters premarket notification submissions [510(/c)s], u.s. food & dr.uo admin., http://www.fda.gov/medical 744 indiana heal til law review [vol. 9:2 mobile health application that is geared towards the general consumer rather than medical providers. another example that is still in development will allow users to give themselves eye exams with their own mobile devices. netra, a software and add-on developed by researchers at the massachusetts institute of technol­ ogy ("mit"), is an application that can provide eye exams from consumers' phones.69 the application requires an add-on piece that allows the user to look through it and will indicate if the user is nearsighted, farsighted, or has astigmatism. 70 the developers explained that the add-on costs only two dollars. they are looking to obtain fda approval for the application. 71 this example proves that companies are already aware of the possibility of regulations and are preemptively looking for approval. nevertheless, there are many applications that have yet to seek approval likely because there is little guidance on the topic from the proper authorities. resolutionmd mobile by calgary scientific is another mobile appli­ cation marketed toward medical providers. the application allows users to view radiology images on their mobile device and will also provide capabil­ ity for video consults. 72 the medical professional can view ct and mr images through their device. the fda has approved the mobile software for the iphone and ipad but is still seeking clearance for android devices. 73 in addition, health canada has approved the mobile application for diag­ nostic use. 74 this example is unique because it has already been approved. nonetheless, this highlights a major dividing line with mobile health appli­ cations: the software offers the ability to diagnose, yet there are many ap­ plications that are just as complex, but their developers are unsure of the need for fda approval. one example of such an application is the istethoscope. the istetho­ scope pro, developed by undercover scientist software, is an application used on the iphone marketed towards the consumer.75 the user can take the iphone, place it on their chest, and the user can record their heartbeat.76 the phone can show a phonocardiograph display of your information.77 in addi­ tion, the phone can send the recording and images of the readings to anyone devices/deviceregulationandguidance/guidancedocuments/ucm07136l.htm (last updated feb. 9, 2012). 69. eye exam? there's an app for that: think of device as 'thermometer for the eye', thedenverchannel.com (oct. 4, 201 0), http://www.thedenverchannel.com/health/ 25277124/detail.html. 70. ld. 71. id. 72. resolutionmd mobile, calgary scientific inc., http://www.calgaryscientific. com/index.php?id=5 (last visited nov. 4, 201 0). 73. id. 74. jd. 15. see istethoscope, ffi.jnes preview, http://itunes.apple.com/us/app/istethoscope­ pro/id322110006?mt=8# (last visited nov. 4, 2010). 76. id. 77. seeid. 2012] fda regulations of mobile phone apps as medical devices 745 else through email.78 this type of application functions much like a stetho-· scope yet has not received any regulation of its uses. the one capability that each of the above examples have in common is the ability to diagnose a medical purpose. on one hand, these applications could help service the world, yet these applications also represent a signifi­ cant risk to the user. consumers could download these applications and use them on their own in lieu of a medical provider at the risk that the infor­ mation the consumer receives from an application might be faulty or incor­ rect. the bottom line is that these applications will only increase in their complexities and uses over time. therefore, the fda needs to issue strict guidelines that balance regulation and innovation needs. v. regulation of medical devices mobile health applications and mobile applications in general have very little oversight. the process of bringing technology to the consumer is an issue of time. the first software developer to bring the application to market reaps the benefits of being the innovative genius that developed such an application. up until this point, mobile applications have stayed on this path of little, if any regulation. however, with the increases in technol­ ogy and innovation, applications have become more prone to regulation. in particular, mobile health applications are now being viewed and regulated as medical devices. it is necessary to take a moment to analyze the current fda methods when evaluating what constitutes a medical device and how it should be regulated. a. medical device definition by fda normally, ifa product meets the fda definition of a medical device, then the product is subject to pre and post marketing regulations by the fda. the definition of a medical device is as follows: an instrument, apparatus, implement, machine, con­ trivance, implant, in vitro reagent, or other similar or related article, including a component part, or acces­ sory which is: recognized in the official national formulary, or the united states pharmacopoeia, or any supplement to them, intended for use in the diag­ nosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and 78. seeid. 746 indiana health law review which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not de­ pendent upon being metabolized for the achievement of any of its primary intended purposes. 79 [vol. 9:2 examples of medical devices regulated by the fda include tongue depressors, bedpans, laser surgical devices, and x-ray machines. 80 the def­ inition itself is broad for the purposes of regulating many different devices. the fda's definition of a medical device is extremely broad in that it describes a medical device as "an instrument ... intended for use in diagno­ sis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals."81 likely many of the ap­ plications discussed previously in this note are covered under such a broad definition. for example, some of the informational applications could be used to prevent disease or to diagnose. however, one of the most important guidelines when deciding whether these applications need fda approval is looking to the purpose ofthe application. many of the mobile health appli­ cations discussed have various intended uses, but this all depends on the particular facts of each piece of software. overall the most fundamental aspect to understand is that the fda has a broad definition for a purpose. the purpose requirement is to maintain safety for consumers who use these devices and to make sure that there is regulatory control in cases of defec­ tive products. b. classes of medical devices under the fda medical devices under the fda are broken into different classes: class i, class ii or class iii. these classes designate what amount of regu­ latory control is needed on the different· types of medical devices. each category represents different risks associated with the product as well as covering the varying timelines for when an application can be brought to market. class i devices have the least regulatory control. in most cases, these devices have a small potential for harm for the user and are simpler in de­ sign. examples of class i devices include bandages, examination gloves, and certain surgical instruments.82 these devices are subject to general 79. is the product a medical device?, u.s. food & drug admin., http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyour device/ucm05l512.htm (last visited feb. 29, 2012); 21 u.s.c. § 321(h) (2010). 80. !d. 81. !d. 82. general and special controls, u.s. food & drug admin., http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/genemlands 2012] fda regulations of mobh..e phone apps as medical devices 747 controls that include: registration of the company, device registration, and tracking of the activities of company. moreover, devices must be manufac­ tured under the good manufacturing practices, the devices must be labeled in accordance with regulations, and the device must be submitted to pre­ market notification before the device can be marketed.83 however, accord­ ing to the fda, "[ m]ost class i devices are exempt from the premarket notification and/or good manufacturing practices regulation.'.84 the second class of device is a class ii medical device. "class ii de­ vices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances."85 because class ii devices require more regulation, products are subject to the general controls of class i devices but also special con­ trols. "special controls may include special labeling requirements, manda­ tory performance standards, and postmarket surveillance.''86 class ii devices include products such as a powered wheelchair, infusion pumps, or surgical drapes. 87 this type of classification requires more time and in­ vestment on the part of the software developer or manufacturer. class iii devices are the most regulated devices under fda controls. "class iii devices are those for which insufficient information exists to as­ sure safety and effectiveness solely through general or special controls. •>m class iii devices usually sustain human life or prevent injuries or they could allow an unreasonable risk of injury. 89 because of the risks involved with these products, class iii devices require premarket approval which includes actual scientific· evidence that the device is safe and effective for the prod­ ucts use.9° class iii devices that require this stringent approval fall into the following categories: "(1) regulated as new drugs prior to may 28, 1976, also called transitional devices; (2) devices found not substantially equiva­ lent to devices marketed prior to may 28, 1976; (3) class iii preamendment devices which, by regulation in 21 cfr, require a premarket approval ap­ plication.'091 examples include implantable pacemaker pulse generators and endosseous implants.92 these are the three levels of regulation that a mobile health applica­ tion might receive depending on whether it is found to be a medical device. obviously all three categories require different regulation. nevertheless, what type of regulation mobile health applications will face is still unpecialcontrols/default.htm (last visited feb. 29, 2012). 83. /d. 84. /d. 85. !d. 86. /d. 87. /d. 88. /d. 89. /d. 90. /d. 91. u.s. foon&drugadmin.,supranote 89. 92. /d. 748 indiana health law review [vol. 9:2 known. to complicate matters, the fda regulates software differently de­ pending on whether it is deemed a component or an accessory. both defini­ tions change how the application: is regulated and who is responsible for bearing the risk of the device through the fda regulation process: c. component vs. accessory regulation understanding if an application is a component or an accessory changes the regulation imposed by the fda. the difference between the two can impact companies in numerous ways, and it is paramount for health software developers to understand the difference. bradley merril thomp­ son,. a shareholder with the law firm epstein becker & green, explains that "[i]n the area of mobile health technology, it's important to understand that an accessory or a component of a medical device is itself a regulated medi­ cal device."93 regardless of recognition, both are regulated medical devic­ es. companies must look toward who is purchasing the application to decide whether the device is a component or accessory. thompson puts it simply. "end-users buy accessories, while manu­ facturers buy components.'094 of course a more in depth analysis needs to be taken, however this is a strong guidepost for analyzing this issue. the fda wants to protect the end-user as much as possible but in the most effi­ cient manner. the ultimate question technology companies must answer is whether the differences in components or .accessories will impact their own design process. first, the component/accessory distinction will affect the manufacturer design process. depending on what the device is determined to be, ulti­ mately the regulations will rest with fda oversight or the manufacturer. · thompson explains that "[c]omponents are exempt from most fda regula­ tory requirements, with the regulatory burdens being borne by the finished device manufacturer."95 "accessories, on the other hand, since they go right to the end user, must meet the fda requirements before they leave the hands of the accessory manufacturer.'.% these two requirements push the burden to different parties related to the device. the tension is between the manufacturer of the phone and the devel­ oper of the web application. for example, if the phone manufacturer were to bear the burden of the fda regulations, developers would not have to worry about the regulations. however, the manufacturer would likely cre­ ate standards to maintain fda regulations within their own processes. on 93. bradley merr1l thompson, fda regulation of mobile healm 3 (2010), available at http://mobihealthnews.com/wp-contentlpdf7fda_ regulation_ of_ mobile_ health. pdf. 94. !d. 95. id. 96. !d. 2012] fda regulations of mobile phone apps as medical devices 749 the other hand, if the application developer were required to bear the bur­ den, then the manufacturer would not have to develop those protocols. these are the current dilemmas facing developers and manufacturers of mobile devices. nevertheless, analysis of the current mobile health applica­ tions can help explain how some applications are classified as medical de­ vices and whether all mobile health applications should be classified as medical devices. vi. are mobile applications medical devices? many developers are aware of potential fda regulations regarding their applications. however, there is very little guidance on what mobile health applications fall into the category of medical devices. some mobile health applications have already applied for fda approval, yet there are many developers unsure as to whether their application is applicable to the same regulatory standards. the different types of mobile health applica­ tions were discussed earlier, but this number is only increasing. due to this problem the fda needs to submit detailed guidance regarding the use and development of mobile health applications. a. fda regulation of software to add some guidance to these issues, understanding the fda guide­ lines regarding software in medical devices is required. the fda has dealt with software contained in medical devices for at least a decade. through the years the fda has changed these guidelines in numerous ways as the agency learns more about the interaction between software and medical de­ vices. as a result, the fda has attempted to create guidelines that take "the least burdensome approach. "97 but, there are still substantial issues that must be dealt with when developing software for a medical device. the fda submitted guidelines for most software in medical devices, which includes firmware, stand-alone software applications, and accessories to medical devices.98 the fda explains that the software referred to in its regulation of devices are those that "contain one or more software compo­ nents, parts, or accessories, or are composed solely of software. "99 as a result, this definition could very likely apply to mobile health applications. even the fda explains that these guidelines apply to "software devices re­ gardless of the means by which the software is delivered to the end user."100 97. guidance for the content of premarket submissions for software contained in medical devices, u.s. food & drug admin., http://www.fda.gov/medicaldevices/device regulationandguidance/guidancedocuments/ucm089543.htm (last updated may 18, 2011). 98. /d. 99. /d. 100. /d. 750 indiana heal til law review [vol. 9:2 the particular suggestions by the fda regarding medical devices con­ taining software are numerous. first, software should be labeled major, moderate, or minor. 101 a major label is a software enabled device that "could directly result in death or serious injury to the patient or operator."102 a moderate label applies to a software device that could result in a minor injury.103 lastly, a minor label applies a software device that is unlikely to cause an injury. 104 · the above regulations are only one method of regulating software un• der the level of concern method. another method is through regulation of the software's inherent risk and intended use. according to the mhealth regulatory coalition, "intended uses of mhealth software can b~ broken into four categories: l) display and storage; 2) transmission; 3) collection; and 4) analysis."105 then, the software is broken down into one of five dif­ ferent categories of inherent risk. 106 by categorizing software into intended uses and inherent risk, the amount of fda regulatory oversight can be ascertained. generally, though, defining the point at which software becomes a medical device is not easy. in fact, applications that do similar actions and allow access to similar in:­ formation might be regulated differently. the mhealth regulatory coali-. tion explains that: [a] scale that displays an individual's weight has an extremely low inherent risk if the individual is merely using the data for personal wellness purposes, yet the same display of the same data may have a moderate or high inherent risk if the patient is required to notify a healthcare provider when their weight reaches a cer­ tain point.107 finally, in 2011 the fda issued a final rule creating a new category for software called medical device data systems ("mdds"). 108 the fda defines a mdds as a device ''that is intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data ... [which] acts only as the mechanism by which med101. id 102. u.s. food & drug admin., supra note 186. 103. id 104. jd. 105. bradley merrill thompson et al., a call for clarity: open questions on the scope of fda regulation of mhealth 37 (2010), available at http://mhealth regula­ torycoalition.org/wp-contentlup1oads/201 0/12/mrcwhitefinal12221 o.pdf. 106. id. 107. id. at 38. 108. medical devices; medical device data systems, 76 fed. reg. at 8637-8638 (feb. 15, 2011) (to be codified at 21 c.f.r. pt. 880) .. 20 12] fda regulations of mobile phone apps as medical devices 751 ical device data can be transferred, stored. converted, or displayed."109 ac­ cording to this definition, it appears the fda is limiting mddss to all sys­ tems or software that transfers, stores, or converts medical device data without changing the function of the connected medical device itself. although this definition appears clear, it does create some substantial issues· for mobile health. first, if the purpose of the rule is to classify the mdds as a class i device, the device will be exempt from premarket noti­ fication. however, if a company is not aware its software falls under the mdds rule, these companies will likely now be subject to registration with the fda aild other reporting and quality requirements. this assumes that the company recognizes it was subject to the mdds rule previously or is now subject to the current standard. nevertheless, the consequences for falling outside the mdds ·classification are substantial. for companies that were not previously subject to the mdds classifi­ cation, they may be now. this creates two distinct problems. first, a com­ pany may discover that it is no longer within the definition and is not subject to fda class i requirements. second, a company may find out that it is outside the mdds classification but still subject to fda regulations. in short, this means that previously unregulated software may now be clas­ sified as a class it or class id medical device. from a larger perspective, the mdds rule enlarged the category while also limiting the category to class i devices. practically speaking, the mdds regulation creates common issues for providers, practitioners, and developers. first, the data itself can go through multiple sources before reaching a mdds device. a medical device can send data to device a, b, c, d, and finally reach the mdds device in ques­ tion and still be regulated. second, health record management may fall un­ der this classification. for example, software used for the transfer of health records to multiple healthcare organizations could be regulated. however, it is important to note that manually entered data is not considered medical device data under this rule. no furthermore, the mdds classification ap­ plies to the software creator as well as manufacturers, providers, and health care organizations that choose to create their own software. the differences between premarket approval and premarket notifica­ tion are considerable from a costs perspective. for example, the fees for premarket notification in 2012 will be $4717, whereas the costs for submit­ ting a device for premarket approval "can reach $1,000,000, plus user fees of an additional $185,000 in fy 2008, increasing to $256,384 in 2012."111 nonetheless, these three methods of defining when software must be regu109. medical devices; medical device data system, 76 fed. reg. at 8638. 110. medical devices; medical device data system, 76 fed. reg. at 8639. 111. devices: general hospital and personal use devices; reclassification of medical device data system, 73 fed. reg. at 7502 (feb. 8, 2008) (to be codified at 21 c.f.r. pt. 880). 752 indiana health law revmw [vol. 9:2 lated as a medical device creates difficulties with new mhealth companies developing mobile applications. the three fda software guidance docu­ ments still leave considerable questions as to whether an application re­ quires regulation and if so, what regulation is necessary. b. bearing the burden of regulation as discussed earlier, there are many questions regarding what compa­ ny is responsible for the regulations that the fda imposes on mobile health applications. for example, the iphone appstore and the android market both have medical application categories. 112 if apple, for example, begins marketing their iphones or ipads to physicians, this might trigger an intend­ ed use regulation for the manufacturer.113 in fact, apple has apparently staged presentations for physicians regarding the uses of their ipad and iph­ one for medical purposes.114 however, since android is an open source software, it has not directly marketed its products to physicians simply be­ cause android does not manufacture the phones themselves. another prime example is with the carriers themselves, such as at&t or verizon. the mhealth regulatory coalition highlights the possibility of a triggering of the accessory rule. "a loss of service may implicate at&t, which provides wireless communication for all iphone users."115 if this happened, at&t could become a regulated entity under the accessory rule due to the transmission of medical data.116 there are competing arguments on all sides. for instance, although apple or motorola manufactures the devices, it is the actual applications themselves performing the medical pro­ cesses. additionally, although the developers create the applications, they are merely components of the actual devices intended purposes.117 finally, the communication companies providing wireless connectivity are already regulated devices that use the network at their own regulatory risks. nevertheless, apple has already established its own way of avoiding these complex issues. as of 2009, apple has included in their developer agreement for applications a section labeled "regulatory compliance for health, medical and related apps."118 in part, the clause states that the 112. medical category, itunes preview, http://itunes.apple.com/us/genre/ios­ medicallid6020?mt=8 (last visited oct. 31, 2010); imedicalapps, google officially launch­ es medical category for android apps (dec. 23, 2010), http://www.imedicalapps.com/ 201 0/12/google-medical-android-apps/. 113. u.s.fooo&drugadmin., supmnote88. 114. husain, supra note 57. 115. bradley merrill thompsonetal.,supranote 115, at32. 116. !d. 117. see generally id. 118. brian dolan, apple puts onus of fda clearance on iphone developers, mobihealthnews (jun. 9, 2009), http://mobihealthnews.com/264llapple-puts-onus-of-fda­ cleamnce-on-iphone-developers/. 2012] fda regulations of mobile phone apps as medical devices 753 developer: will fulfill any applicable regulatory requirements, in­ cluding full compliance with all applicable laws, regulations, and policies related to the manufacturing, marketing, sale and distribution of your application in the united states, and in particular the require­ ments of the u.s. food and drug administration ("fda"), and the laws, regulations and policies of any other applicable regulatory bodies in any coun­ tries or territories where you use or make your ap­ plication available. 119 nonetheless it is necessary to understand the competing interests at s.take regarding mhealth. for now, though, the fda is viewing the devel­ opers of the applications as the ones responsible for bearing this burden. c. current fda approved mobile applications although there is little guidance strictly regarding mobile health ap­ plications, the fda has approved mobile health applications through their current processes. one of the earliest mobile health applications to be ap­ proved was the airstrip ob developed by airstrip.120 the application al­ lows physicians to remotely monitor data from the mother and child for use by ob physicians.121 the type of viewable information includes heart rates, contraction patters, as well as exam information performed by the physi­ cian.122 however, on the apple app store, a disclaiiner explains that the application "is intended for use by obstetricians who deliver babies."123 according to the fda approval letter, the application is considered a class ii medical device and is categorized in pennatal monitoring system and ac­ cessories.124 the fda categorizes medical devices into classifications because they must be substantially equivalent to other regulated medical devices.125 119. id 120. fda approves airstrip's iphone application, san antonio bus. j. (apr. 6, 2009), http://www.bizjournals.com/sanantonio/stories/2009/04/06/daily8.htjnl. 121. id. 122. id. 123. airstrip ob, itunes preview, http://itunes.apple.com/us/app/airstripob/id309381240?mt=8 (last visited dec. 31, 2010). 124. letter :from janine m. morris, acting director, division of reproductive, ab­ dominal, and radiological devices, u.s. food & drug admin., to mark job, responsible third party, regulatory technology services, llc (jan. 23, 2009), available at http://www.accessdata,fda.gov/cdrh_docs/pdf9/k09006l.pdf. 125. u.s. food & drug admin., supra note 91. 754 indiana health law review [vol. 9:2 however, if there is no similar regulated device currently available, the de­ veloper must go through premarket approval rather than premarket notifica­ tion.126 here, airstrip ob was found to be substantially equivalent to perinatal monitoring systems and accessories under 21 c.f .r. § 884.2740.127 although the airstrip ob was able to find a predicate or simi­ lar medical device already classified, many mobile health applications are so new that no other device can currently perform the same processes. one example of not having a predicate device has been with the developer of mimvista. mimvista, the developer of the mobile mim application, received a letter from the fda explaining that they were required to take their mobile application off the appstore.128 mark cain, cto of mimvista, explains that the purpose of the application is to offer "full-resolution medical imag­ es, like ct, mr, or x-rays, with easy-to-use image controls such as win­ dow/level, zoom, and pan."129 on january 29, 2010 mimvista received a letter stating that the "device has new technological characteristics that could adversely affect safety and effectiveness and raise new types of safety and effectiveness questions .... therefore, this device is classitied by stat­ ute into class iii."130 because the application was defined as a class iii medical device, the fda requires pma approval or premarket approval. 131 the pma process will require clinical trials and consistent research for the application to be fda approved. this example highlights the regulatory issues negatively impacting technological innovation. however, in february of 2011 mimvista was given fda 510(k) clearance. 132 the fda explained that "the application is the first cleared by the fda for viewing images and making medical diagnoses based on com­ puted tomography (ct), magnetic resonance imaging (mri), and nuclear 126. !d. 127. 21 c.f.r. § 884.2740 (2012). 128. brian dolan, interview: the iphone medical app denied 510(k), mobihealthnews (mar. 15, 2010}, http:l/mobihealthnews.com/6932/interview-the-iphone­ medical-app-denied-51 olc/5/. 129. !d. 130. greg freiherr, fda fires warning shot over smart phone bow, diagnostic imaging (mar. 31, 2010), http://www.diagnosticimaging.com/news!display/article/113619/ 1547114. 131. premarket approval (pma) is the fda process of scientific and regulatory review to evaluate the safety and effectiveness of class iii medical devices. class iii devices are those that support or sustain human life, are of substantial importance in preventing impair­ ment of human health, or which present a potential, unreasonable risk of illness or injury. see premarket approval (pma), u.s. food & drug admin., http://www.fda.gov/ medi­ caldevic­ es/deviceregulationandguidancelhowtomarketyourdevice/premarketsubmissions!premarketap provalpmaldefault.htm (last updated jan. 24, 2012). 132. brian dolan, fda clears first diagnostic radiology app, mobile mim, mobihealthnews (feb. 4, 20ii), http://mobihealthnews.com/10173/fda-clears-first­ diagnostic-radiology-app-mobile-mim/. 20 12] fda regulations of mobile phone apps as medical devices 755 medicine technology, such as positron emission tomography (pet)."133 however, the fda was quick to point out that "[i]t is not intended tore­ place full workstations and is indicated for use only when there is no access to a workstation."134 this is just one recent issue developing with the clear­ ances of mobile health applications and the manner in which they are used. nonetheless, the fda also changed their opinion on the device being a class ill. to gain 510(k) clearance the device must be classified as a class ii device. although the device has been cleared, the clearance itself raises substantial questions of use and classification. current fda regulated mobile health applications demonstrate the need for some form of regulation. however, many software developers have never had to deal with the process and have little if any information regarding their applications. for example, cain explained that as of march 2010 it had been two years since their mobilemim application was devel­ oped and that "[f]or tech-minded people like us, that's an incredibly long time."135 currently mobilemim's application is available in india, austral­ ia, hong kong, singapore, and the united kingdom. 136 if the united states wants to become a world leader in a whole new industry, the fda must develop clear guidelines to balance the interests of safety and innovation in mobile technology. in conclusion, the fda should create cohesive guide­ lines to foster innovation and safety among the new mhealth industry. vii. regulatory solutions for mobile healm applications although there is a myriad of issues involved with fda regulation of mobile health applications, it is necessary to focus on the most important questions. it is equally as important to remember that mobile health appli­ cations represent a considerable risk to users, patients, and physicians. this risk cannot go unnoticed, and the technology industry needs to recognize that regulation is not only inevitable but necessary. a balance can be reached between innovation and regulation by more clearly defining a regu­ latory scheme for mobile health applications. first, is it possible to define what mobile health applications should be regulated and what applications should not be regulated? the answer is yes and no; it will ~hange significantly with the types of innovations yet to be seen in the future. for example, twenty years ago it was tough to imagine a future where cell phones could carry and operate as mobile health assis­ tants. now, however, cell phones and tablets have the possibility to offer health solutions to people with very little access to health care. to begin, it is necessary to discuss what types of applications should not be regulated. 133. id 134. /d. 135. dolan, supra note 138. 136. ld. 756 indiana health law review [vol. 9:2 a. defining non-regulated mobile health applications there are two forms of mobile health applications that will help define a line between what types of applications should be regulated and what ap­ plications should not be. one example is a form of application that is mere­ ly informational. informational applications are similar to websites in that they convey information that is readily available from other sources. these other sources could include print media, or online resources such as webmd. although information health applications can pose a risk to the patient or consumer, the information is to educate rather than to diagnose. consumers may use this information for personal diagnoses, but that is not the intended use of the application. another form of mobile health applications that should not be regulat­ ed is lifestyle monitoring applications. lifestyle monitoring applications include applications used for diets, weight tracking, cardiovascular logging, or even merely calorie counting. these applications allow the user to input their own person information such as height, weight, and sex to customize the results of the application. for example, myfitnesspal, an application for tracking weight loss and fitness, is designed to be customized to the us­ er's personal needs.137 once the user inputs his or her height, weight, sex, and goal weight, the application returns the amount of calories needed to be consumed per day to lose that weight.138 although applications such as the­ se use patient information for health related reasons, they are not intended for use as a diagnosing tool but rather as a tracking tool. most applications in this category simply allow the user to track their own data. although the differences in mobile health applications are subtle, to create clarity within the process, the subtleties must be analyzed. first, an application can be categorized based on the actual purposes of the applica­ tion. this bridges the gap between a new method of analyzing these appli­ cations and the current method used by the fda.139 second, the application can then be properly placed within .one of these two categories (informa­ tional or diagnostic), if the purpose matches. for example, the purpose of a mobile health application might be for inputting your health information and then the application displays medical advice. the purpose is informa­ tional; therefore, the application can then be placed within the informational category. above all, the pertinent issue is that clarity needs to be brought to the process to spur development within this new industry. however, under­ standing what applications should not be regulated helps hone in on what applications should be regulated. 137. myfitnesspal, http://www.myfitnesspal.com/ (last visited mar. 11, 2011). 138. ld. 139. see generally u.s. food & drug admin., supra note 88. 2012] fda regulations of mobll..e phone apps as medical devices 757 b. defining regulated mobile health applications now that certain applications can be categorized as non-regulated, the key question is whether it is possible to clearly define what mobile health applications should be regulated as medical devices. although. there is no doubt that there should be differing levels such as class i or class ill devic­ es, the answer is one of simplicity. to have a strict definition is not as im­ portant, at this point, as having a definition that helps developers understand when their application should be regulated as a medical device. the key answer is that any mobile health application that is not informational or lifestyle monitoring should be regulated. however simple this may be, simplicity has its benefits. in general, with this definition comes more clarity. right now there is no dividing line, yet, if this guideline is taken seriously, there is a definite line of what should be regulated and what should not be. for example, an application where the user inputs their height, weight, and other medical information would be characterized as lifestyle monitoring. however, an application that uses mobile technology to take your heart rate would be more than that and would need to be regulated.140 although some form of a gray area will always exist, this at the very least creates a dividing line for developers. the end goal for the fda, companies, and developers should be to create a more predictable regulatory process. by simplifying the process, the fda could create a system that is clear and predictable for developers. additionally, the fda would not have to risk missing certain mobile health applications simply because there is little clarity in the current process. for example, the heart monitoring application is being marketed right now but arguably could be marketed as a medical device.141 this general method of defining what mobile health applications should be regulated will allow developers to have a bright line definition to help them understand that they are not allowed to market their applications until they are approved. unfor­ tunately, the current fda process and new methods have not addressed the­ se concerns. c. current fda position on medical device review the fda has faced increased scrutiny over the 501(k) medical device review process throughout the years.142 nonetheless, recently the fda has 140. see appbrain, supra note l. 141. see id 142. jaimie oh, house hears arguments over fda's medical device approval pro­ cess, becker's asc review (feb. 23, 2011 ), bttp:/lwww.beckersasc.com/asc-supply-cbain­ materials-managementlbouse-bears-arguments-over-fdas-medical-device-approval­ process.html. 758 indiana health law review [vol. 9:2 implemented programs to make the approval process run more efficiently in hopes ofbringing medical devices to market at a faster pace while maintain­ ing safety procedures.143 the fact that the fda has made changes to im­ prove the process shows that there has been and still are substantial issues impeding the medical device industry in the united states.144 . because of these issues, in 2011 the fda released draft guidance for mobile medical applications.145 . in february of 2011, the fda announced the launch of the medical device innovation initiative;146 the director of the fda's center for de­ vices and radiological health, dr. jeffrey shuren, explained that the review program cover devices "that demonstrate the potential to revolutionize dis­ ease treatment, diagnosis, or health care delivery and that target unmet med­ ical needs."147 the fda labels the initiative as the innovation pathway, which gives priority to the newest medical technology and devices.148 alt­ hough the fda has not finalized the program, the fda has outlined several aspects to help the public understand the. new program. first, the new innovation pathway program itself is not drastically dif­ ferent than the current 51 o(k) or pma regulatory paths. in fact, the fda explained that ''the innovation pathway is not a new regulatory pathway," but "it is a special program that gets cdrh involved earlier in the device development process."149 at first glance, the program appears to be a new­ er and quicker review process, but the fda explains that "enrollment in the innovation pathway would not change the scientific or regulatory standards that cdrh would use to evaluate device submissions."150 nevertheless, the program does purport to offer more timely and efficient reviews of medical device products.151 .the fda believes that the process will reduce review times from 300 days to approximately 150 days.152 this is significant, re­ gardless of whether this is a new regulatory path. nonetheless, there are still questions regarding what devices will be eligible. 143. kathryn foxhall, fda offers simpler path for new medical devices, government health it (feb. 9, 2()11), http://www.govhealthit.com/newsitem.aspx?nid= 76196. 144. chris kaiser, fda and industry square off over approval process, cardiovascularbusiness (feb. 24, 2011), http://www.cardiovascularbusiness.com/ in­ dex.php?option=com_articles&view=article&id=26490&division=cvb. 145. draft guidance for industry and food and drug administration staffmobile medical applications, u.s. food & drug admin. {july 21, 2011 }, http://www.fda.gov/ medicaldevices/deviceregulationandouidance/ouidancedocuments/ucm263280.htm. 146. foxhall, supra note 153. 147. !d. 148. u.s. food & drug admin., questions and answers about the medical device innovation initiative (feb. 8, 2011), http://www.fda.gov/aboutfda/centersoffices/ of­ ficeotmedicalproductsandtobacco/cdrh/cdrhinnovationlucm242068.htm. 149. !d. 150. /d. 151. !d. 152. !d. 20 12] fda regulations of mobile phone apps as medical devices 759 the fda is attempting to implement this process due to the drastic changes in medical device technology. currently, the devices that would reviewed within this process are devices that "would be radically different from any legally marketed medical device in the united states in their un­ derlying technology or manner of use. ,.153 additionally the device must significantly improve current treatments or diagnosis for life-threatening conditions.154 this includes a device for which there is no approved alter-. native treatment, a device that addresses an unmet public health need, or a device that addresses a national security issue.155 the requirements are broad, and likely to change, but it does not appear that mobile health appli­ cations would fit into these requirements. although mobile health applications contain drastically different tech­ nology, the only additional category that appears to fit would be public health. for many mobile health applications, the application addresses a need where many people do not have access to medical care. additionally, most mobile health applications that should be regulated might not fit into that category because the technology is drastically different. unfortunately, until the fda chooses to address the technological changes with mobile health, the problem of clarity will not be resolved. in order to address this issue, the fda must simplify the process for mobile health applications. in an attempt to further clarify the categorization of mobile health ap­ plications, the fda released draft guidance on the regulation of mobile medical applications in july of2011.156 the document itself leaves much to be understood. nevertheless, it appears that the fda intends to regulate mobile medical applications when u8ed as ari accessory to a medical de­ vice.m the document explains that "[a] mobile medical app that simply supports the intended use of a regulated medical device could be classified as [a] class r• device.158 notably, the mobile application must not change the intended use of the medical device to which it is connected. 159 in addition, the fda intends to classify a mobile medical application in the same class as the connected medical device if the medical device "ex­ tends the intended use of the connected device ... 160 this example would be prevalent when a mobile application is used as an accessory to a connected medical device yet uses more detailed analysis than the connected medical device itself. in a sense, this might occur if the application is used more as a data analysis tool rather than purely informational tool. unfortunately, if 153. id 154. id 155. id 156. !d. 157. !d. 158. !d. 159. !d. 160. !d. 760 indiana health law review [vol. 9:2 a mobile medical application extends the use of a class ii medical device, it would be subject to the same regulatory review. moreover, a mobile medical application may be subject to more strin­ gent regulatory controls if that application creates a new intended use than that of the connected medical device.161 for example, a mobile medical application may provide diagnostic support based off of its connection to a medical device. if the connected medical device was not intended to pro­ vide that support, the fda may regulate these applications in any class de­ pending on the "risk posed to patient safety by the new intended use."162 finally, mobile medical applications that allow the user to input patient specific information which is processed to "aid a clinician in making a di­ agnosis" will also be regulated.163 although this guidance does provide much needed information to the industry, major issues still remain. one major issue is that, according to the fda, all mobile medical applications belong in one category. the fda appears to not differentiate between mobile medical applications that in­ volve humans and those that do not. another major issues is that, as previ­ ously discussed, intended use can be a difficult definition to pursue. both intended use and practitioner professional use need to be evaluated for clari­ ty in the industry. nevertheless, one thing that is clear is that wellness mo­ bile apps will not be subject to fda regulation. these include apps that allow users to input diet or exercise information. unfortunately, the fda's current stance is limited to this document, providing little transition from the current burdensome medical device approval process. viii. fast track solution for mobile health the current process, although in the midst of changes, is not a process that has ever been very amenable to the medical device industry. although safety standards are at some of the highest levels, the industry leaders main­ tain that the process is hurting the industry. for example, start-up compa­ nies in the medical device sector have dropped by thirty-seven percent since 2007.164 although this drop can be attributed to multiple issues, there is no doubt that the current regulatory scheme plays a role in this drop. addi­ tionally, biosensors international, a californian medical device company shut down its united states company last year.165 the ceo, jeffrey b. jump, explained that biosensors international left because of the regulatory process and would rather spend their money abroad where processes are 161. id. 162. !d. 163. !d. 164. andrew pollack, medical treatment, out of reach, n.y. times (feb. 9, 2011), http:/ /www.nytimes.com/20 11/02/1 0/business/1 odevice.html?pagewanted=all. 165. id. \ 2012] fda regulations of mobile phone apps as medical devices 761 easier. 166 knowing this, the fda has the opportunity to test a new model on technology, such as mobile health applications, that is a hybrid between the european system and the current fda regulatory processes. a. european model summary in order to understand this hybrid model, it is helpful to analyze the european· approval process in summary. the european approach and the approach in the united states have many differences. 167 although these differences bring about many issues of quality and safety, recent studies have shown smaller differences than anticipated with regards to the safety of medical devices brought to market.168 nonetheless, the process is differ­ ent and has resulted in products coming to market at a faster pace. for ex­ ample, heart valves for open-heart surgery have been available in europe since 2007, yet they will not be available in the united states until2011 at best. 169 this example is one of many that highlight the positives of the eu­ ropean process. currently, the european process is directed by the medical device di­ rective, the in-vitro diagnostic directive, and the active implantable med­ ical device directive.170 however, each individual country has its own competent authority that certifies different for-profit notified bodies that are authorized to certify medical devices.171 in europe, there are over sev­ enty notified bodies that can authorize the use of certain medical devic­ es.172 once a medical device manufacturer wants to bring their device to market, they choose a notified body to send materials such as clinical data or literature reviews for the notified body to review.173 the notified body then performs quality assessments on the manufacturing process, and upon approval, the device has access to the european market.174 although the process is extremely decentralized, it has resulted in similar outcomes as the fda process with faster approval. a recent study analyzed the recall data that is available in both the united states and europe, finding that the numbers of recalls were identical and the types of recall were similar.175 for example, in the united states 166. /d. 167. scott davis et al., eu medical device approval safety assessment (2011 ), available at http://www.advamed.org/nr/rdonlyres/061a4ac8-d6a3-4960-826b-672214 aoa623/0ireportbcgeuropeanussafetyfinal.pdf. 168. /d. at 1. 169. pollack, supra note 174. 170. davis et al., supra note 177. 171. /d. 172. id 173. /d. 174. id 175. !d. at 1. 762 indiana health law review [vol. 9:2 both the recall rates for pre-market and post-market issues were nearly iden­ tical within the study. 176 generally though, the results of the study "suggest little difference between absolute number of serious recalls between the us and eu regulatory systems."177 the study even explained that "given the expectation that the eu approves more devices than the us it is likely that the eu recall rate may actually be slightly lower than the us rate."178 in conclusion, the study suggests that the overall safety argument against the european system is hindered by this data and that results are similar. b. benefits of separate regulatory scheme to propose an entirely new model for regulation would consume an­ other complete article, but certain guidelines should be followed to help the transition of mobile health technology. for mobile health applications, a separate regulatory system is necessary and beneficial to the industry, con­ sumers, and the government. there are a few important points to keep in mind regarding mobile health applications. first, mobile technology itself moves at an extremely quick pace. 179 this creates problems with a regula­ tory process because inherently, the process itself slows the innovation re­ lated to mobile technologies more so than most other types of medical devices. second, access to mobile health applications is constantly at the fin­ gertips of any person with a mobile phone. issues with access can hardly be prevented with mobile technologies, whereas actual medical devices are rarely accessible to the consumer. for example, by 2015, it is estimated that 500 million people will have mobile health applications on their smartphones.18° finally, the current model does little to differentiate what mobile health applications are subject to regulatory approval. however, these issues can become catalysts for improving and implementing a new hybrid model for regulating mobile health applications as medical devices. it is because of these very issues that certain guideposts should be followed by the fda in future implementations of regulatory schemes. c. a test model for mobile health applications the fda has the opportunity to drastically change its approach to 176. id. at 7. 177. /d. at 10. 178. !d. 179. brett miller, constantly changing technologies: what's a software developer to do?, mashable (dec. 20, 2010), http://mashable.com/2010/12/20/constantly-changing­ technologies/. 180. egle mikalajunaite, 500m people will be using healthcare mobile applications in 2015, research2guidance (nov. 10, 2010), http://www.research2guidance.com/500m­ people-will-be-using-healthcare-mobile-applications-in-2015/. 20 12] fda regulations of mobile phone apps as medical devices 763 medical device regulations with an industry that is still in its infancy. the proposed changes should include the following suggestions to help improve the system as a whole. in fact, the fda needs to implement an entirely dif­ ferent regulatory scheme for mobile health applications. while regulating these applications as medical devices under the pma or 501(k) process can be done more easily since the process is not changing, it is less advanta­ geous to the industry as a whole. by maintaining the same outdated regula­ tory scheme, these applications and the industry are being held back. the process was not developed for such quick evolving and accessible technol­ ogies but for technologies that were evolving at a slower rate and less ac­ cessible directly to the consumer. second, unless the mobile health application is informational or life­ style monitoring, the application should be regulated. if a mobile health application does not fit into one of those categories, then it must go through the regulatory process. the main reason technology companies and devel­ opers are having problems with the current process is because very little clarity exists. developers are struggling to even understand the process.181 here though, the definition is simple yet efficient. if an application merely relays information much like a public website, then it needs no regulatory approval from the fda. likewise, lifestyle monitoring applications merely allow the user to input their own information to understand how healthy they are or certain tests that may be needed. mobile health applications beyond these two categories must face approval. by moving to a less com­ plex definition, the fda can bring clarity to the process. third, like europe, the fda should take a decentralized for profit ap­ proach to mobile health application approval. one of the major problems with such quick paced technology is that it is tough for even experienced developers themselves to keep pace with the changing technologies.182 the only plausible method to keep up with these changes is to leave it to private companies who are incentivized to stay up to date on the newest technolo­ gies. as mentioned previously, this decentralized method in europe has resulted in similar recalls as have occurred the united states medical device system.183 for profit entities could register with the fda to operate under fda guidelines to approve these products. generally, a similar approach can be taken to the european process. this would solve industry concerns of needing updated regulatory schemes for constantly changing technology and safety issues by allowing incentivized developers analyze and approve the products. finally, the fda can require developers, companies, and application stores to prevent mobile health applications to market themselves unless 181. miller, supra note 189. 182. !d. 183. davis et al., supra note 177, at 10. 764 indiana health law review [vol. 9:2 approved. there is a current need for some restraint considering the analyt­ ical depth of some of these applications that are currently available for download to a consumer's phone. as mentioned earlier, if the application is merely informational or lifestyle monitoring, then it would be able to be marketed immediately. currently, because of the lack of clarity, developers and companies are marketing these applications without knowing that they are subject to regulation. by creating penalties, application stores will be more vigilant and aware of the regulatory scheme. this will in turn influ­ ence the access factor. right now, access is at a maximum whereas this would create a balance to safely transition consumers to use these applica­ tions. however, most applications beyond the informational and lifestyle monitoring will likely be used by practitioners. although these are merely guidelines and suggestions, the fda should take this opportunity to transition into a more efficient model. by testing a new regulatory scheme on mobile health applications, the fda will be able to balance safety and innovation properly. the fda can solve the clarity, access, and efficiency problems merely by offering a more de­ centralized process for newer technologies. however, it should be noted, this note is not advocating a complete shift in the entire process of medical devices, but offers a new model for mobile technologies. although the mo­ bile technology industry is just beginning, the fda could follow these guidelines to implement a safe, efficient, and innovative regulatory policy for the united states mobile technology industry. ix. conclusion regardless of the outcome, the fda must address this issue because the mobile application industry is expanding at an alarming rate. for the united states to remain competitive, the process needs to be more stream­ lined so that developers within the industry know where they stand. alt­ hough there are many issues surrounding the approval of medical devices in the united states, the fda is at a crossroads of opportunity. on one hand is the opportunity to help in the expansion of a new industry within the united states, yet on the other hand is the chance to further fuel the prob­ lems that have plagued the fda medical device regulatory scheme. the purpose of this note is not to propose a new standard model for fda ap­ proval of mobile health applications. instead this note seeks to start a meaningful conversation which will hopefully result in advantageous re­ sults for both consumers and the industry. racial disparities in mental health treatment: how indiana misses the mark in providing accessible and quality treatment amidst the coronavirus pandemic allyson crane* i. introduction doctors, organizations, and citizens have expressed the importance of mental health, equating its significance to physical health.1 despite the numerous conversations about mental health, treatment continues to fall short.2 this is especially the case for people of color.3 people of color are at a significant disadvantage in terms of access to quality mental health treatment.4 living in poverty, lacking access to health insurance coverage, and discrimination by providers are just a few examples of how people of color struggle to receive quality mental health treatment.5 the coronavirus pandemic has exacerbated people of color’s limited access to mental health care.6 while some providers have offered telemedicine as an alternative to in-person mental health treatment,7 this is not an accessible option for everyone.8 those living in low-income households may lack the required technology to access telemedicine,9 or the providers within a person’s community * j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.s. 2015, indiana university. 1. see nicole spector, mental health: how we’ve improved and where we need to do better in 2020, nbc news (jan. 10, 2020, 3:53 pm), https://www.nbcnews.com/better/lifestyle/ mental-health-how-we-ve-improved-where-we-need-do-ncna1108721 [https://perma.cc/kf42dm2h]. 2. id. 3. person of color, merriam-webster, https://www.merriam-webster.com/dictionary/ person%20of%20color [https://perma.cc/dqd2-a2lb] (last visited mar. 28, 2021) (“a person whose skin pigmentation is other than and especially darker than what is considered characteristic of people typically defined as white; a person who is of a race other than white or who is of mixed race.”). 4. see racism and mental health, mental health am., https://www.mhanational.org/ racism-and-mental-health#_ftn4 [https://perma.cc/46ka-29xd] (last visited jan. 30, 2021). 5. id. 6. nirmita panchal et al., the implications of covid-19 for mental health and substance use, kaiser fam. found. (feb. 10, 2021), https://www.kff.org/coronavirus-covid-19/issuebrief/the-implications-of-covid-19-for-mental-health-and-substance-use/ [https://perma.cc/rwq4nrtf]. 7. id. 8. id. 9. underserved populations least likely to use telehealth options, gwtoday (dec. 3, 2018), https://gwtoday.gwu.edu/underserved-populations-least-likely-use-telehealth-options [https://perma.cc/2mxs-m66z]. 428 indiana health law review [vol. 19:427 or health care network may not offer virtual mental health appointments.10 as a result, many people of color are developing mental health conditions as a result of social isolation and other stressors brought on by the coronavirus pandemic and are unable to receive mental health treatment.11 it is imperative that health care providers and government officials review current legislation regarding mental health treatment to address inaccessibility, with an emphasis on inaccessibility for people of color. from there, legislation should be proposed that will better protect people of color and allow them easier access to quality mental health treatment. programs that address accessibility and quality of mental health care for people of color should also be enacted to help increase the number of individuals who seek treatment. not only will more people of color be seeking treatment, but they will also experience quality treatment that produces positive outcomes. a. issue: racial disparities in mental health treatment while white people experience reasonable accessibility and good quality mental health care, people of color still face great disparity in accessibility and quality.12 these disparities include being discriminated against by providers, limited access to mental health resources due to being disproportionately poor and experiencing higher rates of persistent and chronic mental health conditions.13 the coronavirus pandemic has helped to intensify these disparities.14 1. racial discrimination by providers discrimination by providers against people of color significantly contributes to the disparities in mental health treatment.15 many providers have racial bias and are unable to properly treat a person of color in a non-discriminatory manner.16 placing time constraints on when a person of color may receive mental health services or limiting the mental health resources for a person of color are just two ways in which providers choose to discriminate against people of color when they are seeking mental health services.17 10. id. 11. see dennis thompson, mental health ‘epidemic’ threatens communities of color amid covid-19, u.s. news (feb. 26, 2021), https://www.usnews.com/news/health-news/articles/202102-26 /mental-health -ep idem ic-th rea t en s-com m u n it ie s -of -color-amid-covid-19 [https://perma.cc/a8rb-58jv]. 12. racism and mental health, supra note 4. 13. id. 14. panchal et al., supra note 6. 15. susan fiske, stereotyping, prejudice, and discrimination, in 2 the handbook of social psychology 357, 357 (mcgraw-hill 4th ed., 1998). 16. id. 17. see brian d. smedley, the lived experience of race and its health consequences, 102 am. j. pub. health 933 (2012). 2022] racial disparities in mental health treatment 429 cultural competence plays a pivotal role in racial discrimination.18 people of color are less likely to experience discrimination when seeking mental health treatment from culturally competent providers.19 cultural competence allows providers to treat patients who are people of color based on their values and needs.20 culturally incompetent providers are unable to tailor services to a patient of color’s needs, likely minimizing the positive effects of mental health treatment.21 2. people of color are limited in their access to mental health due to being disproportionately poor accessibility to mental health services is limited for people of color.22 the poverty rate for people of color is much higher than it is for white people.23 over 21% of black people and 17% of hispanic people live in poverty, compared to 9% of white people.24 people of color living in poverty often do not have access to health insurance, or to other resources that would make mental health treatment a feasible option for their household.25 racial and ethnic minorities may not have access to health services, may have to wait a long time to receive services, or may not receive the correct services that would create a positive mental health outcome.26 people of color cannot benefit from receiving quality mental health care if they cannot access it.27 3. people of color are more likely to suffer from mental health illnesses a person of color’s mental health is greatly affected by provider discrimination and their limited access to mental health care. research has found that black people experience higher rates of anxiety and depression as a result of provider discrimination, living in poverty, and their limited access to mental health care.28 also, people of color have higher rates of suicide than white 18. fiske, supra note 15, at 360. 19. racism and mental health, supra note 4. 20. id. 21. id. 22. id. 23. poverty rate by race/ethnicity, kaiser fam. found, https://www.kff.org/other/stateindicator/poverty-rate-by-raceethnicity/?currenttimeframe=0&sortmodel=%7b%22colid%22:% 22location%22,%22sort%22:%22asc%22%7d [https://perma.cc/lh2n-kruc] (last visited feb. 5, 2021). 24. id. 25. smedley, supra note 17, at 933. 26. id. at 934. 27. see id. 28. thomas a. vance, addressing mental health in the black community, colum. univ. dep’t psychiatry (feb. 8, 2019), https://www.columbiapsychiatry.org/news/addressing-mental430 indiana health law review [vol. 19:427 people.29 mental health conditions among people of color tend to be more persistent and the severity of the conditions increase over time.30 in order to address the higher rates of mental health problems with people of color, the issues of discrimination, lack of access, and the numerous other barriers people of color face in mental health care must be resolved.31 4. covid-19 has exacerbated racial disparities in mental health treatment covid-19 disproportionately affects people of color.32 the “essential” workforce is mainly comprised of people of color, and people of color are more likely to become unemployed as a result of the pandemic.33 as a result, many people of color either lack the time or the income to seek mental health treatment.34 despite the heightened levels of anxiety and stress in individuals in the u.s. due to the pandemic,35 people of color continue to experience racial disparities in mental health care.36 not only is their physical health in danger, due to the higher rates of being exposed, but their mental health is at risk as well.37 b. indiana’s lack of legislation and how the state compares to others in 2020, indiana enacted legislation that requires the behavioral health commission to release a report each year that evaluates access to mental health treatment, funding, mental health providers, and makes a comparison to other state and national programs.38 since this is new legislation, a report has yet to be released. indiana offers no other legislation on racial disparities in mental health care, especially legislation that actively works on diminishing racial disparities in mental health treatment. the purpose of the behavioral health commission is to evaluate access to treatment, but it is not specified whether they will offer health-black-community [https://perma.cc/3zjy-q8eq]. 29. david r. williams, stress and the mental health of populations of color: advancing our understanding of race-related stressors, 59 j. health soc. behav. 466, 479 (2018). 30. id. at 466. 31. see id. 32. see double jeopardy: covid-19 and behavioral health disparities for black and latino communities in the u.s., substance abuse & mental health servs. admin. 1, https://www.samhsa.gov/sites/default/files/covid19-behavioral-health-disparities-black-latinocommunities.pdf [https://perma.cc/8qgc-rzb6] (last visited feb. 15, 2021). 33. jeanna smialek & jim tankersley, black workers, already lagging, face big economic risks, n.y. times (june 2, 2020), https://www.nytimes.com/2020/06/01/business/economy/blackworkers-inequality-economic-risks.html [https://perma.cc/6jlm-3gbl]. 34. id. 35. id. 36. double jeopardy, supra note 32. 37. id. 38. ind. code § 12-21-7-1 (2020). 2022] racial disparities in mental health treatment 431 strategies or solutions to access barriers.39 due to the statute’s enaction being so recent, it is likely that it will take several years for it to be effective, if it proves to be effective at all.40 in comparison, many other states have drafted, proposed, and passed legislation relating to mental health care.41 most of these bills recognized the existence of racial disparities and emphasized the rampant provider discrimination present in the mental health care system.42 the federal government has also attempted to enact legislation to improve mental health and limit the disparities in treatment that people of color experience.43 despite these attempts, few were enacted into law.44 those that were codified often did not produce the results intended.45 in order for states, including indiana, to improve the quality and access to mental health treatment, the federal government needs to take the necessary measures to address it.46 c. the coronavirus pandemic and its role in the shift toward telemedicine covid-19 has had a significant effect on access to mental health care.47 providers are shifting to the use of telemedicine to ensure that individuals still have access to healthcare.48 “telemedicine involves the use of electronic communications and software to provide clinical services to patients without an in-person visit.”49 however, many providers use telemedicine for patients to use for appointments related to their physical health.50 fewer telemedicine appointments are available for mental health treatment.51 people of color are at a significant disadvantage in accessing quality mental health care through the means of telehealth.52 people of color disproportionately live in poverty and low-income areas, and often lack technology for telehealth to 39. id. 40. id. 41. the federal and state role in mental health, mental health am., https://www. mhanational.org/issues/federal-and-state-role-mental-health [https://perma.cc/e942-sw3q] (last visited mar. 28, 2021). 42. id. 43. id. 44. id. 45. id. 46. id. 47. panchal et al., supra note 6. 48. id. 49. what is telemedicine?, chiron health, https://chironhealth.com/telemedicine/what-istelemedicine/ [https://perma.cc/g8hm-m5tu] (last visited sept. 30, 2020). 50. id. 51. id. 52. underserved populations least likely to use telehealth options, supra note 9. 432 indiana health law review [vol. 19:427 even be an option.53 providers within these communities or healthcare network also did not offer virtual mental health appointments.54 since many mental health care providers did not offer telemedicine as a means of receiving treatment, people of color were left to cope with their mental health conditions on their own.55 the coronavirus pandemic has limited access to mental health services for people of color even though those services were severely limited prior to the pandemic.56 ii. background a. the growing importance of access to mental health treatment mental health treatment in the u.s. has increased over the last decade as more of the u.s. population has recognized the importance of mental health and access to mental health care.57 before this, people only acknowledged and spoke of mental health when referring to severe mental illnesses.58 federal and state laws were enacted that recognize the importance of mental health and attempt to “[put] mental health on the same level as physical health.”59 one piece of legislation is the mental health parity and addiction equity act of 2008 (“mhpaea”).60 mhpaea prohibits health insurance plans and networks from limiting mental health benefits more than medical benefits for physical health.61 another example of legislation that recognizes the importance of mental health is the affordable care act of 2010 (“aca”).62 the aca discusses mental health in numerous aspects, including recognizing it as an “essential health benefit.”63 in the last decade, the united states has seen tremendous growth in recognizing mental health as an essential health service and is reflected in their inclusion of it in legislation.64 the aca has expanded medicaid coverage to over 37 million individuals.65 yet, this expansion did not improve the accessibility to 53. id. 54. see celeste campo-castillo & denise anthony, racial and ethnic differences in selfreported telehealth use during the covid-19 pandemic: a secondary analysis of a us survey of internet users from late march, 48 j. am. med. informatics assn. 119 (2020). 55. double jeopardy, supra note 32. 56. id. 57. spector, supra note 1. 58. id. 59. id. 60. h.r. 6983, 110th cong. (2008). 61. id. 62. see patient protection and affordable care act of 2010, pub. l. no. 111-148, 124 stat. 119 (2010) (codified as amended 42 u.s.c. § 18001). 63. h.r. 6983. 64. the federal and state role in mental health, supra note 41. 65. see patient protection and affordable care act of 2010. 2022] racial disparities in mental health treatment 433 mental health services.66 people of color continue to struggle in accessing mental care treatment that will prove to be successful and is covered through their insurance.67 this is an even more pressing issue for the people of color who were unable to retain health insurance and remain uninsured.68 legislation is not the only area in which mental health treatment is recognized. social media has “played a positive role here as have influential people who are starting to speak more about their mental health, which helps to reduce the stigma.”69 through the sharing of personal mental health stories, other people have been able to understand and accept common mental health conditions.70 the recognition and acceptance of mental health conditions by society also encourages those with mental health conditions to seek mental health services.71 it subsides their fear of being ridiculed for seeking help and allows them to relate to others in society who may be in the same or similar situation.72 this is especially important for people of color, as there is often a stigma around seeking mental health treatment.73 society also has much influence over addressing racism.74 people of color have been advocating for equal rights for decades.75 while progress has been made, many organizations and groups continue to fight against racism and educate others on the subject76 racial trauma is a significant factor in a person of color’s mental health.77 the eradication of racial violence and discrimination will significantly reduce the racial trauma people of color experience.78 the discrimination people of color experience exists within mental health services, as providers racially discriminate against their patients of color.79 by eliminating or greatly diminishing racism, society will also be significantly reducing racial disparities in mental health care.80 66. id. 67. williams, supra note 29. 68. id. 69. spector, supra note 1. 70. id. 71. id. 72. id. 73. id. 74. see alex pieterse & shantel powell, a theoretical overview of the impact of racism on people of color, in the cost of racism for people of color: contextualizing experiences of discrimination 11 (alvin n. alvarez et al. eds., 2016). 75. id. 76. id. 77. monnica t. williams, uncovering the trauma of racism, am. psych. ass’n (feb. 13, 2019), https://www.apa.org/pubs/highlights/spotlight/issue-128 [https://perma.cc/7hyt-uaqv]. 78. id. 79. fiske, supra note 15. 80. id. 434 indiana health law review [vol. 19:427 b. history of discrimination in mental health treatment people of color have experienced discrimination in health care treatment for decades.81 as such, this reflects the outcomes people of color receive from their mental health treatment.82 “experiences of discrimination in healthcare settings may contribute to disparities in mental health outcomes for blacks and latinos.”83 because discrimination in mental health treatment is so prominent, the accessibility of mental health care is just the first of many obstacles people of color must face when they are in need of mental health treatment.84 “even when blacks and latinos do receive mental health/substance abuse services, they are more likely than whites to obtain inappropriate diagnoses, drop out of treatment early, report less satisfaction with treatment, and receive inadequate or substandard care.”85 studies have shown that there are several factors that contribute to people of color not receiving quality mental health treatment.86 these factors include lack of insurance, difficulty finding services that can be provided in their native language, and a sense of distrust toward healthcare professionals due to the “historical mistreatment in health care settings.”87 multiple studies show how disparate mental health treatment is between white people and people of color, that the disparities have worsened, and little progress is being made to correct these disparities.88 in 2015, only 31% of black and hispanic people received mental health services, compared to 48% of white people.89 factors contributing to the access to treatment include lack of insurance, stigma around mental illness, lack of mental health providers who are people of color, culturally incompetent providers, and distrust in the health care system due to misdiagnosis.90 one study found that black men are over diagnosed with schizophrenia, as they four times more likely than white men to be diagnosed.91 yet, they are underdiagnosed with posttraumatic stress disorder and mood 81. see vickie m. mays et al., perceived discrimination in healthcare and mental health/substance abuse treatment among blacks, latinos, and whites, 55 med. care 173 (2017). 82. id. 83. id. 84. id. 85. id. 86. id. 87. id. 88. see thomas g. mcguire & jeanne miranda, racial and ethnic disparities in mental health care: evidence and policy implications, 27 health aff. 393 (2008). 89. mental health disparities: diverse populations, am. psychiatric ass’n, https://www. psychiatry.org/psych iatr ists/cu ltu ral-competency/education /mental-health -facts [https://perma.cc/c8n7-vr7h] (last visited jan. 30, 2021). 90. id. 91. tahmi perzichilli, the historical roots of racial disparities in the mental health system, counseling today (may 7, 2020), https://ct.counseling.org/2020/05/the-historical-rootsof-racial-disparities-in-the-mental-health-system/ [https://perma.cc/l7aq-ybz]. 2022] racial disparities in mental health treatment 435 disorders.92 when people of color are diagnosed with a mental illness or disorder, they receive medication or therapy at a lower rate than white people.93 another study suggests that white mental health professionals, who make up 86% of licensed psychologists, are often culturally incompetent, leading to misdiagnosis of mental illness in people of color.94 cultural incompetence creates barriers, such as language differences or cultural presentations of symptoms, that limit a provider’s ability to identify an explanation for misdiagnosis or from preventing a misdiagnosis.95 as a result, “black and african american people are more likely to experience chronic and persistent, rather than episodic, mental health conditions.”96 c. telemedicine and its growing presence telemedicine is “the use of technology (computers, video, phone, messaging) by a medical professional to diagnose and treat patients in a remote location.”97 there has been an increase in the use of telemedicine for mental health care in recent years.98 this is due to the development of technology and the push to streamline delivering health care services and making the health care system more efficient.99 providers are able to treat more patients through telemedicine and can reach patients who are unable to travel to a provider’s office.100 despite the rapid development of telemedicine, not all providers offer telemedicine or have plans to incorporate it into their practice of medicine.101 however, more mental health services are being offered through telemedicine due to the coronavirus pandemic.102 “the federal government and many states governments have expanded coverage of telemedicine and relaxed certain regulations to alleviate the impact of business closures and social distancing on access to needed care.”103 the coronavirus aid, relief, and economic security 92. id. 93. see racial/ethnic differences in mental health services among adults, substance abuse & mental health servs. admin. 1 (feb. 2015), https://www.samhsa.gov/data/ sites/default/files/mhservicesuseamongadults/mhservicesuseamongadults.pdf [https://perma.cc/f2eh-8jdf]. 94. see perzichilli, supra note 91. 95. see id. 96. black and african american communities and mental health, mental health am., https://www.mhanational.org/issues/black-and-african-american-communities-and-mental-health [https://perma.cc/km43-lp39] (last visited jan. 30, 2021). 97. what is telemedicine?, supra note 49. 98. panchal et al., supra note 6. 99. id. 100. id. 101. id. 102. id. 103. id. 436 indiana health law review [vol. 19:427 act (“cares act”) appropriated $425 million to the substance abuse and mental health services administration (“samhsa”).104 this funding helps alleviate the costs associated with offering telemedicine as a means for receiving mental health services.105 by offering these funds to mental health care providers, the government is encouraging providers to use telemedicine to effectively treat patients and offer quality mental health resources amidst a pandemic where inperson visits are virtually impossible.106 despite the increase in use of telemedicine as a result of the coronavirus pandemic, telemedicine is still not accessible for everyone.107 this is especially the case for people of color in lowincome areas.108 those who are unable to obtain mental health resources for their mental health conditions must cope with the additional stressors that derive from the coronavirus pandemic, such as social isolation, lack of income, and fear of contracting or contracting covid-19.109 iii. analysis a. racial disparities in mental health treatment several racial disparities in mental health care severely limit a person of color’s ability to obtain quality, accessible mental health treatment.110 the disparities are closely related, leaving it nearly impossible to solve one without addressing the others.111 without addressing the disparities people of color experience, such as racial discrimination, being disproportionately poor, higher rates of chronic mental health conditions, and the exacerbation of disparities due to the coronavirus pandemic, the mental health of people of color will continue to deteriorate.112 1. racial discrimination by providers nearly 86% of licensed psychologists are white.113 of those, research suggests that many have racial biases and stereotype their patients.114 “many minority patients receive a lower quality of health care than whites, even when 104. see coronavirus aid, relief, and economic security act, pub. l no. 116-136, 134 stat. 281 (2020). 105. id. 106. id. 107. campo-castillo & anthony, supra note 54. 108. id. 109. id. 110. perzichilli, supra note 91. 111. id. 112. id. 113. id. 114. id. 2022] racial disparities in mental health treatment 437 access-related factors are controlled.”115 the bias and stereotyping of these providers create a sense of fear and mistrust among people of color.116 this may deter people of color from seeking treatment completely or may prevent a person of color from taking a provider’s advice. racism has been institutionalized in white people since before the founding of the united states.117 with this came scientific racism.118 samuel cartwright, an american physician in the nineteenth century, defined the word “drapetomania” as a mental illness that black people suffered from, causing them to seek freedom.119 along with coining this term, cartwright claimed that any black person who was free experienced mental illness at a higher rate than those who remained enslaved.120 even with a lack of evidence to support this claim, the u.s. census supported this claim, using it as “a political weapon against abolitionists.”121 as years progressed, people of color were subject to various medical experimentation and the mislabeling of their behavior.122 people of color, particularly black people, were viewed as angry, unwell, and hostile.123 rather than being provided with quality mental health treatment, black people were often incarcerated or institutionalized in state psychiatric hospitals.124 this history of mental health treatment, or lack thereof, for people of color provides an explanation for why racial disparities in mental health care remain prominent presently. years of people of color being ignored and mislabeled has contributed to the cultural incompetence of mental health providers, greatly inhibiting the dismantling of institutional racism and discrimination. the cultural incompetence of mental health providers limits their ability to properly treat people of color. a provider must be able to “recognize and understand the role of culture . . . and the ability to adapt the treatment to meet the client’s needs within their cultural framework.”125 mental health providers can educate themselves and become well-versed in treating people of color and those who belong to different cultures by recognizing what they do not know and proceeding to ask questions.126 by asking questions, mental health providers can then ensure they are meeting their client’s needs as well as future clients with similar concerns. if more mental health providers become culturally competent 115. smedley, supra note 17. 116. black and african american communities and mental health, supra note 96. 117. perzichilli, supra note 91. 118. id. 119. id. 120. id. 121. id. 122. id. 123. id. 124. id. 125. vance, supra note 28. 126. see mona shattell & paula brown, racism, white privilege, and diversity in mental health, 55 j. psychosocial nursing & mental health servs. 2 (2017). 438 indiana health law review [vol. 19:427 when treating clients, it will greatly decrease the discrimination of people of color when seeking mental health treatment. psychiatrists and psychologists associations, such as the american psychological association have acknowledged the issue of racism in mental health treatment and developed guidelines to address it but have failed to offer solutions.127 the guidelines include being aware of racial issues, adapting to the needs of people of color to properly address their concerns, and include an approach in treatment that addresses racism-related issues people of color experience.128 for example, there is a stigma that seeking help for mental health issues is a sign of weakness.129 it is imperative that mental health providers help dismantle this stigma and encourage those in need to seek help and put in the work to help improve their mental health.130 2. people of color are limited in their access to mental health due to being disproportionately poor 21% of black people and 17% of latinx are living in poverty in the u.s., compared to only 9% of white and asian people.131 based on these statistics, people of color are more likely to be poor than white people. lack of access to resources and experiencing additional stressors are two examples of how people of color who live in poverty experience disparities in mental health treatment. those living in poverty often lack the resources to access quality mental health care. low-income people are less likely to have health insurance.132 only 31% of low-income workers receive employer health care plans, compared to 58% of high-income workers.133 when employers do not offer their low-income employees health care benefits, low-income workers are forced to receive healthcare elsewhere, leaving nearly 26% of low-income workers uninsured.134 people of color are disproportionately affected by this since they are nearly twice as likely to live in poverty than white people are.135 black people are 1.5 times more likely and hispanic people are 2.5 times more likely to be uninsured than white people.136 uninsured people of color living in poverty experience several 127. see jude mary cénat, how to provide anti-racist mental health care, 7 lancet psychiatry 929 (2020). 128. id. 129. shattell & brown, supra note 126. 130. id. 131. poverty rate by race/ethnicity, supra note 23. 132. see ronald m. andersen et al., access to medical care for low-income persons: how do communities make a difference?, 59 med. care rsch. & rev. 384 (2002). 133. alanna williamson et al., aca coverage expansions and low-income workers, kaiser fam. found. (june 10, 2016), https://www.kff.org/report-section/aca-coverage-expansions-andlow-income-workers-issue-brief/ [https://perma.cc/du4m-cjqz]. 134. id. 135. poverty rate by race/ethnicity, supra note 23. 136. samantha artiga et al., changes in health coverage by race and ethnicity since the 2022] racial disparities in mental health treatment 439 barriers in access mental health care.137 with no health insurance, they are forced to pay for most, if not all, medical expenses out of pocket.138 many choose to forego seeking any health treatment, including mental health care.139 people of color living in poverty lack the necessary income to afford physical health care, not to mention mental health care.140 those who do choose to seek mental health care often receive care of lesser quality than those who are considered highincome.141 reasons for this include racial discrimination and lack of coverage from their group or employee insurance plan.142 while some still choose to seek mental health care despite these reasons, others may be deterred from seeking treatment.143 quality mental health care is difficult to obtain if you are a person of color living in poverty, a glaring disparity in mental health treatment.144 low-income people of color have higher rates of behavioral and environmental factors to cope with.145 studies have shown that living in poverty can trigger depressive episodes, as people in poverty often experience more stressful situations than someone who lives above the poverty level.146 lowincome americans also experience higher rates of smoking, obesity, substance use, and chronic stress than higher income americans.147 with these additional stressors, low-income people of color are likely to experience higher rates of mental health issues.148 despite coping with mental health issues at a higher rate, low-income people of color face the difficulty in receiving quality mental health care, or mental health care at all. aca, 2010-2018, kaiser fam. found. (mar. 5, 2020), https://www.kff.org/racial-equity-andhealth-policy/issue-brief/changes-in-health-coverage-by-race-and-ethnicity-since-the-aca-20102018/ [https://perma.cc/xwm7-a543]. 137. jennifer tolbert et al., key facts about the uninsured population, kaiser fam. found. (nov. 6, 2020), https://www.kff.org/uninsured/issue-brief/key-facts-about-the-uninsured-population/ [https://perma.cc/qrg4-hs8y]. 138. id. 139. id. 140. id. 141. andersen et al., supra note 132. 142. id. 143. id. 144. id. 145. dhruv khullar & dave chokski, health, income, & poverty: where we are & what could help, health aff. (oct. 4, 2018), https://www.healthaffairs.org/do/10.1377/hpb20180817. 901935/full/ [https://perma.cc/2uwm-qfmz]. 146. see krysia n. mossakowski, is the duration of poverty and unemployment a risk factor for heavy drinking? 67 soc. sci. & med. 947 (2008). 147. khullar & chokski, supra note 145. 148. see jennifer robinette et al., neighborhood features and physiological risk: an examination of allostatic load, 41 health & place 110, 110 (2016). 440 indiana health law review [vol. 19:427 3. people of color suffer more from mental illness mental health conditions occur in people of color at about the same rate as white people.149 however, cases of mental illness in black people and latinx are often more severe and tend to last longer than other race groups.150 in addition, people of color living in poverty are two times as likely to experience psychological distress than those living above the poverty level.151 provider discrimination and living in poverty are both detrimental to a person of color’s health and must be addressed in order to improve the severity and frequency of mental health illnesses among people of color. black people experience higher rates of anxiety and depression,152 and people of color have higher rates of suicide than white people.153 the rate of people of color suffering from a serious mental illness has continued to rise from 2008 to 2018.154 there are numerous reasons that contribute to the higher rates of chronic mental illnesses among people of color. racial trauma significantly contributes to mental health conditions among people of color.155 people of color are subject to microaggressions, racial violence, and oppression which all leave an effect on their mental health.156 people of color are subjected to these actions frequently, making the mental health effects persistent. living in poverty, which people of color experience at a higher rate than white people, is another factor that creates additional stressors for people of color.157 there are many other factors that people of color subject to that create a lasting effect on their mental health.158 despite these numerous factors that have been identified, people of color continue to suffer with poorer mental health at an increasing rate and are limited in their treatment plan due to other racial disparities in mental health care. 4. covid-related racial disparities the coronavirus pandemic has created further mental health disparities for people of color. on a global scale, people are reporting higher levels of stress, 149. black and african american communities and mental health, supra note 96. 150. williams, supra note 29. 151. see serious psychological distress in the past 30 days among adults aged 18 and over, by selected characteristics: united states, average annual, selected years 1997-1998 through 2015-2016, ctr. disease control & prevention (2017), https://www.cdc.gov/nchs/data/hus/ 2017/046.pdf [https://perma.cc/cc4e-msrk]. 152. vance, supra note 28. 153. williams, supra note 29. 154. black and african american communities and mental health, supra note 96. 155. kristen rogers, people of color face significant barriers to mental health services, cent. news network (oct. 10, 2020), https://www.cnn.com/interactive/2020/10/health/mentalhealth-people-of-color-wellness/ [https://perma.cc/a9yt-zkyc]. 156. id. 157. poverty rate by race/ethnicity, supra note 23. 158. see generally williams, supra note 29. 2022] racial disparities in mental health treatment 441 anxiety, and other mental health disorders.159 there are several factors that contribute to the increase in mental health illnesses, specifically for people of color. first, an individual who has been exposed to covid-19 or has had a close family member or friend exposed to covid-19, often will experience a rise in stress or anxiety as a result.160 second, people of color make up a large proportion of the “essential” workforce, leaving them at a greater risk of exposure and less time to seek mental health treatment.161 30% of the confirmed cases of covid-19 are black individuals, and another 14% are those who identify with multiple backgrounds.162 black people make up nearly 13% of the u.s. population, but make up 25% of covid-19 deaths.163 “the latest overall covid-19 mortality rate for black americans is 2 times as high as the rate for whites and 2.2 times as high as the rate for asians.”164 this is partially due to a higher risk of chronic illnesses among people of color.165 due to the increased risk of contracting covid-19, people of color are already disproportionately impacted by the covid-19 pandemic.166 this coupled with being deemed an “essential” worker or being furloughed, and the limited access and racial discrimination experienced when seeking mental health treatment, people of color’s mental health is likely to suffer more. being deemed as an “essential” worker amidst a pandemic is dangerous to one’s mental health. since many of the essential workers are people of color, they are especially at risk for developing mental health disorders.167 not only do they have to cope with the fear of contracting covid-19 but are often forced to cope in isolation to avoid putting their family and close friends at risk for exposure.168 quarantining and maintaining social distancing are two of the main ways to 159. maria cohut, covid-19: the mental health impact on people of color and minority groups, med. news today (may 18, 2020), https://www.medicalnewstoday.com/articles/covid19-mental-health-impact-on-people-of-color-and-minority-groups [https://perma.cc/s68f-ma8e]. 160. id. 161. smialek & tankersley, supra note 33. 162. double jeopardy, supra note 32. 163. id. 164. the color of coronavirus: covid-19 deaths by race and ethnicity in the u.s., am. pub. media rsch. lab, https://www.apmresearchlab.org/covid/deaths-by-race [https://perma. cc/359t-wbwk] (last updated feb. 4, 2021). 165. see shikha garg et al., hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019, 69 morbidity & mortality wkly. rep. 458 (apr. 17, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm?s_cid=mm691 5e3_w#suggestedcitation [https://perma.cc/n7ah-u87g]. 166. bipoc communities and covid-19, mental health am., https://mhanational.org/ bipoc-communities-and-covid-19#_edn10 [https://perma.cc/x2xv-ab8w] (last visited feb. 15, 2021). 167. see id. 168. id. 442 indiana health law review [vol. 19:427 minimize being exposed to covid-19.169 while 29.9% of white people report that they are able to work from home, only 19.7% of black workers and 16.2% of hispanic workers are able to do so.170 more people of color are forced to go to work with the fear of being exposed to covid-19 and are not provided adequate resources to cope with such stress. not to mention, many people of color who are essential workers do not have time or funds to seek mental health treatment on their own.171 if not deemed as an “essential” worker, people of color are at greater risk of becoming unemployed.172 with no job, people of color often lack health insurance and an income to afford mental health care. additionally, the shift to telemedicine for mental health care treatment has disproportionately affected people of color who live in poverty.173 the coronavirus pandemic has greatly exacerbated the racial disparities in mental health care, despite the lives of people of color being at such a heightened risk. b. indiana’s legislation on addressing the disparities in mental health treatment indiana code section 12-21-7-2 created the behavioral health commission to draft and share reports on behavioral health in indiana.174 the first report was due october 1, 2020.175 the purpose of this commission is to “conduct an assessment of behavioral health in indiana,”176 as well as “[e]valuate barriers to mental health and substance use disorder treatment in indiana…[which] must include an evaluation of the following: (a) mental health systems. (b) access to mental health systems. (c) mental health providers. (d) funding for mental health systems and providers.”177 an assessment of these areas of mental health care allows officials to identify where indiana’s mental health care systems fails in providing accessible, quality mental health care to all who need it.178 the commission’s report will also determine how these failures specifically affect people of color.179 the goal of the commission is also to “assess how age, race, and geographic location affect access to behavioral and mental health treatment.”180 indiana offers no other legislation that aims to improve people of color’s 169. id. 170. tiana rogers et al., racial disparities in covid-19 mortality among essential workers in the united states, world med. & health pol’y 1, 2 (2020). 171. id. 172. smialek & tankersley, supra note 33. 173. campo-castillo & anthony, supra note 54. 174. ind. code § 12-21-7-2 (2020). 175. ind. code § 12-21-7-4(a)(1) (2020). 176. ind. code § 12-21-7-4(c)(1) (2020). 177. ind. code § 12-21-7-4(c)(2) (2020). 178. see ind. code § 12-21-7-4 (2020). 179. id. 180. ind. code § 12-21-7-4(f)(6) (2020). 2022] racial disparities in mental health treatment 443 access to quality mental health care. since the behavioral health commission was enacted in early 2020, the commission has been unable to prove its effectiveness.181 not to mention, the commission is in place to assess areas of behavioral health and to offer recommendations on how to improve or evolve the mental health care system, indiana code section 12-21-7-4 does not require the behavioral health commission to enact any policies or laws that would require these improvements or developments be required. recognizing disparities in mental health treatment is merely the first step in ensuring that all hoosiers have access to mental health care and that the treatment they are receiving is quality care that will promote successful outcomes regardless of race. the state has failed to enact legislation that not only promotes, but requires equitable, accessible, and quality treatment to people of color. c. how indiana compares to other states’ and federal legislation indiana is not the only state that has proposed mental health legislation. “during the 2017 legislative sessions, legislators in at least 19 states considered 74 bills related to behavioral health disparities.”182 the “vast majority of bills focused on raising awareness of behavioral health disparities or promoting cultural competency among providers or services.”183 for example, massachusetts considered h.b. 495, which “focused on quality improvements and also tied hospital reimbursement rates to their ability to reduce racial and ethnic disparities in health care.”184 while this legislation was only proposed and not enacted, massachusetts took a step in the right direction by acknowledging that providers do not provide the same mental health care to people of color as they do to white people and proposed legislation that would incentivize them. in pennsylvania, the state adopted h.r. 141, “which focuses on mental health issues in the black community.”185 pennsylvania is acknowledging that mental health is prevalent in black communities and that racial disparities limit the access to mental health care or hinder the quality of it. the federal government has also attempted to enact legislation that will identify and address racial disparities in mental health by drafting h.r. 6637, the health equity and accountability act of 2020.186 h.r. 6637 has not been passed since it was introduced in the house on april 28, 2020.187 unfortunately, it is unlikely that this bill will ever become law since it has been left untouched for so 181. ind. code § 12-21-7-2. 182. the costs and consequences of disparities in behavioral health care, nat’l conf. state legislatures (feb. 2018), https://www.ncsl.org/portals/1/html_largereports/disparities behhealth_final.htm [https://perma.cc/ydt3-4b6e]. 183. id. 184. id. 185. id. 186. h.r. 6637, 116th cong. (2020). 187. id. 444 indiana health law review [vol. 19:427 long. this bill would have been beneficial for eliminating disparities in the health care system, including mental health care.188 the bill included multiple sections on mental health and the racial disparities currently present.189 section 604 of the h.r. 6637 discusses racial mental health disparities and how there are gaps in the studies pertaining to those disparities.190 this section would have required the identification of where the research on racial mental health disparities is nonexistent or how research in certain areas of mental health may differ.191 by identifying these gaps, the federal government could have then determined a course of action for filling in those gaps to ensure that the racial disparities in mental health care are being properly researched and identified in their entirety.192 h.r. 6637 further addresses racial mental health disparities in section 605.193 section 605 identifies the competency level of health professionals and their ability to properly address the racial and ethnic disparities in mental health care.194 this would allow the federal government to see whether health professionals are working to solve the racial disparities or working against it.195 comparatively, indiana fails to identify and address racial mental health disparities at the same level as other states’ as well as the federal government.196 the enactment of indiana code section 12-21-7-1 is a step in the right direction in terms of addressing racial disparities in mental health treatment.197 however, more legislation and awareness are needed to ensure that the disparities identified by the behavioral health commission are resolved in a manner that is beneficial to people of color.198 d. coronavirus, the increased presence of telehealth and its effect on access and quality to mental health treatment the emergence of the coronavirus pandemic drastically affected the everyday life of the world population.199 the risk of transmitting covid-19 and the severity of the illness forced many countries to issue stay-at-home orders and 188. id. 189. id. 190. id. 191. id. 192. id. 193. id. 194. id. 195. id. 196. id. 197. ind. code § 12-21-7-1 (2020). 198. id. 199. covid-19 overview and infection prevention and control priorities in non-us healthcare settings, ctr. disease control & prevention, https://www.cdc.gov/coronavirus/ 2019-ncov/hcp/non-us-settings/overview/index.html [https://perma.cc/9xpr-fbyy] (last updated aug. 12, 2020). 2022] racial disparities in mental health treatment 445 implement safety procedures.200 in indiana, governor eric holcomb issued executive order no. 20-08, directive for hoosiers to stay at home.201 this executive order ordered indiana residents to stay at home beginning on march 24, 2020, and ending on april 6, 2020.202 as covid-19 continued to rapidly spread, governor holcomb extended the stay-at-home order under executive order no. 20-08 to april 20, 2020.203 he then issued another executive order that ordered hoosiers to stay at home until may 1, 2020.204 as fewer cases were being reported, governor holcomb released “back on track indiana,” a roadmap to reopen the state following the stay-at-home orders.205 covid-19 cases continue to rise across the country, greatly affecting access to health care.206 the issuance of the stay-at-home orders forced many businesses to close, including many healthcare services.207 people were unable to obtain access to health care services that they needed, including mental health care.208 for people of color, gaining access to mental health care was already difficult.209 those living in poverty may lack technology for telehealth to even be an option.210 or providers within their community or healthcare network did not offer virtual mental health appointments.211 in fact, “[o]nly 38 percent of community health centers – major health service providers for underserved populations – offered telehealth,” as a way for patients to receive health care services.212 the coronavirus pandemic made access even more difficult.213 “limited access to mental health care and substance use treatment is in part due to a current shortage of mental health professionals, which will likely be exacerbated by the covid19 pandemic.”214 the coronavirus pandemic also created a higher demand for mental health services.215 “people who were sheltering in place (47%) reported negative mental health effects resulting from worry or stress related to coronavirus among those 200. id. 201. ind. exec. order no. 20-08 (2020). 202. id. 203. id. 204. id. 205. what’s open, what’s closed?, in.gov, https://backontrack.in.gov/2348.htm [https:// perma.cc/ 255l-8chm] (last visited nov. 7, 2020). 206. covid-19 overview and infection prevention and control priorities in non-us healthcare settings, supra note 199. 207. panchal et al., supra note 6. 208. id. 209. id. 210. underserved populations least likely to use telehealth options, supra note 9. 211. id. 212. id. 213. panchal et al., supra note 6. 214. id. 215. id. 446 indiana health law review [vol. 19:427 not sheltering-in-place (37%).”216 “more than one in three adults in the u.s. have reports symptoms of anxiety or depressive disorder during the pandemic.”217 with a higher demand and limited access to mental health services, many people were unable to obtain proper mental health care for their mental health conditions that were either brought on or exacerbated by the coronavirus pandemic.218 many of those who were fortunate to obtain mental health care, received such care through telemedicine.219 the united states saw an increased use of telemedicine due to the stay-athome orders issued across the country.220 prior to this, telemedicine was not used as a common alternative to in-person health care services.221 “however, recent policy changes during the covid-19 pandemic have reduced barriers to telehealth access and have promoted the use of telehealth as a way to deliver acute, chronic, primary and specialty care.”222 this included authorizing insurance providers to provide coverage for telemedicine.223 in indiana, there are “staggering increases in the number of people seeking help for mental health and addiction during the coronavirus pandemic, state officials are encouraging hoosiers to utilize telehealth.”224 to ensure that patients can obtain insurance coverage for mental health services through telemedicine, the state passed indiana code section 27-8-34-6.225 this statute provides that “a policy must provide coverage for telemedicine services in accordance with the same clinical criteria as the policy provides coverage for the same health care services delivered in person.”226 telemedicine services for the purposes of this statute include behavioral health.227 however, there are troubling limitations to telemedicine insurance coverage in indiana.228 coverage may not be provided if the provider should deem the services as inappropriate.229 and for those with medicaid coverage, “prior authorization is required for telehealth/telemedicine 216. id. 217. id. 218. id. 219. id. 220. using telehealth to expand access to essential health services during the covid-19 pandemic, ctr. disease control & prevention, https://www.cdc.gov/coronavirus/2019ncov/hcp/telehealth.html [https://perma.cc/xfs9-bb6f] (last updated june 10, 2020). 221. id. 222. id. 223. id. 224. elizabeth depompei, virtual therapy is booming during the pandemic. here’s what it’s like, indystar (apr. 8, 2020, 6:00 am), https://www.indystar.com/story/news/health/2020/04/08/ what-you-need-know-telehealth-therapy-during-coronavirus-pandemic/5078096002/ [https://perma.cc/28y3-ud9e] 225. ind. code § 27-8-34-6 (2015). 226. id. 227. ind. code § 27-8-34-5 (2015). 228. ind. code § 27-8-34-7 (2015); § 27-8-34-6. 229. § 27-8-34-7. 2022] racial disparities in mental health treatment 447 services provided to medicaid covered members.”230 accessibility to telemedicine was the first obstacle health care providers and government officials had to face.231 they then had to ensure that the mental health care and other health care services patients would receive through telemedicine would be quality care.232 “further action by policymakers and public health decision-makers is needed to build on these initiatives and supports the provision of telemental health services, throughout this crisis and beyond.”233 mental health care should not be of lesser quality simply because it is being administered through telemedicine rather than in-person. e. solutions to ending racial disparities in mental health treatment 1. legislation enacting legislation that ensures access to mental health care and requires providers to provide quality mental health treatment to people of color is one of the easiest ways in which the united states to greatly reduce or even eliminate racial disparities in mental health treatment.234 very few states, including indiana, have enacted legislation that does this, as well as the federal government.235 should the federal government propose and enact legislation that works toward solving racial disparities in mental health care, states may feel the pressure to do so as well.236 while there is currently legislation that calls for research on and identifying racial disparities in the health care system, they offer no requirements or calls to action to eliminate such disparities.237 the enactment of the affordable care act (“aca”) expanded the number of people eligible for medicaid, as well as declared mental health services and substance abuse care as essential health benefits.238 over 37 million americans who were uninsured were able to gain medicaid coverage as a result of the aca.239 this included people in indiana, as the state chose to accept the medicaid expansion.240 many of these individuals were low-income and people 230. § 27-8-34-6. 231. see emile whaibeh et al., telemental health in the context of a pandemic: the covid19 experience, 7 current treatment options psychiatry 198 (2020). 232. id. 233. id. 234. artiga et al., supra note 136. 235. the federal and state role in mental health, supra note 41. 236. id. 237. id. 238. patient protection and affordable care act of 2010, pub. l. no. 111-148, 124 stat. 119 (2010). 239. id. 240. status of state action on the medicaid expansion decision, kaiser fam. found. (feb. 12, 2021), https://www.kff.org/health-reform/state-indicator/state-activity-around-expanding448 indiana health law review [vol. 19:427 of color.241 many legislators believed that by expanding the number of individuals eligible for medicaid, the racial disparities associated with access to health care would dissipate.242 by ensuring that mental health services and substance use treatment were an essential health benefit that had to be provided within a health insurance plan, legislators expected mental health care to be easily accessible for people of color.243 despite this expansion in 2010, mental health services did not become more accessible for people of color.244 accessibility to insurance coverage does not alter the racial discrimination by providers.245 white patients are twice as likely than black patients to receive follow-up care after being discharged from an inpatient facility.246 additionally, people of color who live in poverty may not have as many services available to them near their residence who accept their insurance plan.247 expanding those who are eligible for medicaid and other health insurance coverage did not eliminate racial disparities people of color experience in mental health care. 248 the aca failed to properly address accessibility to mental health care for people of color as it intended.249 legislators must amend the aca to address accessibility to mental health care, specifically for people of color. enacting programs that help tailor the services to the patient is one way in making quality mental health accessible.250 this includes locations for facilities251. not all people of color, especially those who are uninsured and in poverty, live near facilities that offer mental health services.252 offering mobile mental health services or providing resources for telemedicine are two programs that can help ensure populations receive treatment without having to travel to the closest facility.253 the aca should also emphasize the importance of tailoring services to the patient’s preferences.254 it can do this by requiring mental health providers to collect data on each patient’s mental health needs, their preferred treatment medicaid-under-the-affordable-care-act/?currenttimeframe=0&sortmodel=%7b%22colid%22:% 22location%22,%22sort%22:%22asc%22%7d [https://perma.cc/65cc-9m48]. 241. see margarita alegria et al., removing obstacles to eliminate racial and ethnic disparities in behavioral health care, 35 health affairs 991 (2016). 242. id. 243. id. 244. id. 245. id. 246. see nicholas j. carson et al., quality of follow-up after hospitalization for mental illness among patients from racial-ethnic minority groups, 65 psychiatry serv. 888 (2014). 247. alegria et al., supra note 241. 248. id. 249. id. 250. id. 251. id. 252. id. 253. id. 254. id. 2022] racial disparities in mental health treatment 449 options, and the barriers they face when seeking mental health treatment.255 this requirement would help ensure that people of color receive accessible, quality mental health care.256 treatment options that are more tailored to the patient will help diminish the persistent mental health conditions that disproportionately affect people of color, as well as provider discrimination.257 by the federal government taking action and amending the aca, they are encouraging other states to do so as well.258 many states have adopted the aca expansions thus far.259 rather than drafting their own legislation, states can easily adopt the specific programs and initiatives enacted in the aca. since indiana has adopted the medicaid expansions in the aca, they will likely codify these recommended programs should the federal government enact them.260 people of color residing in indiana can then experience mental health services with easier accessibility that is tailored to their specific needs, greatly reducing the disparities they currently experience.261 2. pressure from the public racism is very much prevalent in american society, but there has been an increase in demanding the recognition of racial injustices and elimination the discrimination people of color experience in their everyday life. one prime example of this is the black lives matter movement.262 the black lives matter movement was created to put an end to violence and discrimination on black people, as well as ensuring equal accessibility.263 americans continue to advocate for black people and ensuring that they are valued as much as white people are valued in society. as the movement continues to exponentially grow, it includes advocating for access to mental health care and demanding that the treatment they receive is of utmost quality.264 society has caused for a push in recognizing the importance of mental health as well as normalizing seeking mental health treatment.265 because of this, mental health has become an overwhelmingly important topic in american society.266 more american citizens are seeking mental health treatment and are therefore 255. id. 256. id. 257. id. 258. the federal and state role in mental health, supra note 41. 259. status of state action on the medicaid expansion decision, supra note 240. 260. id. 261. id. 262. black lives matter, https://blacklivesmatter.com/ [https://perma.cc/bv95-ljzy] (last visited oct. 4, 2020). 263. id. 264. uncovering the trauma of racism, supra note 77. 265. underserved populations least likely to use telehealth options, supra note 9. 266. id. 450 indiana health law review [vol. 19:427 more likely to see positive mental health outcomes.267 mental health care has made great progress in terms of accessibility and quality as a result of the overwhelming discussions that occurred throughout the years in society.268 society has great influence in dictating what should be made available to the people and how it is being delivered.269 american society is more than capable of pushing for the elimination of racial disparities in the mental health care system.270 educating the public on the racial disparities that are actively occurring in the mental health care system may be beneficial in pressuring in governmental officials and health care providers to ensure that these racial disparities are immediately addressed.271 in order to eradicate racial violence and discrimination, including in mental health care, the people must support it.272 the public has the power to significantly reduce racial disparities in mental health treatment in several ways.273 the eradication of racial violence will decrease the number of people of color who experience racial trauma.274 racial trauma contributes to the increased rates of mental health conditions.275 people of color will experience lower rates of chronic mental health conditions, which will likely decrease the amount of treatment they need to receive.276 addressing racism will also address the disproportionate number of people of color who are considered low-income.277 more people of color will likely gain access to affordable housing and higher paying jobs, as their opportunities will be the same as white people.278 access to affordable housing and better job opportunities offers better insurance coverage and better mental health programs.279 better mental health programs offer services tailored to a person of color’s needs by a culturally competent provider.280 none of these solutions are plausible without society pressuring legislators to enact laws that discuss these programs in-depth.281 267. id. 268. id. 269. id. 270. id. 271. alegria et al., supra note 241. 272. michael p. jaycox, the black lives matter movement: justice and health equity, health progress (nov.-dec. 2016), https://www.chausa.org/publications/health-progress/article/ t h e -common-good/the-black-lives-matter-movem en t -ju s t ice -an d-h ea lth -eq u ity [https://perma.cc/4n2z-6mvt]. 273. id. 274. uncovering the trauma of racism, supra note 77. 275. id. 276. id. 277. jaycox, supra note 272. 278. id. 279. id. 280. id. 281. alegria et al., supra note 241. 2022] racial disparities in mental health treatment 451 3. improvements in accessibility to mental health care the quality of mental health care does not matter if it is not accessible.282 on the local and state level, officials and community members can actively work toward improving accessibility to mental health care for people of color in addition to eradicating racism.283 this can include providing adequate resources to people of color and ensuring that people of color are being made aware of the resources that are available to them.284 this is especially necessary in low-income areas.285 many households who lack insurance coverage and the financial resources to obtain mental health services may not be aware of free or low-cost mental health services.286 many americans are also not made aware of the telemedicine services that are available amidst the coronavirus pandemic.287 local and state officials and community members should be broadcasting telemedicine as an option for receiving mental health services, as well as encourage providers to use telemedicine within their practice. establishing and advertising free or low-cost mental health care facilities in communities where people of color lack the resources to seek mental health treatment is one way in which the accessibility of mental health care can be improved.288 there are currently clinics located across the u.s. that offer health services at little to no cost for individuals who are not eligible for medicare and medicaid and have no health coverage.289 however, not all of these clinics offer mental health services.290 it is imperative that more of the free to low-cost facilities be established in areas where people of color would typically not have access to such resources. these facilities should also be required to offer mental health services. the aca recognizes mental health care and substance use treatment as an essential health benefit and should be accessible to any person who is in need of it, regardless of health insurance coverage.291 success has been seen in communities that have offered mental health services within programs that also offer housing and employment.292 low-income people, which are predominately people of color, “are more likely to adhere to behavioral interventions when these are combined with community resources that 282. id. 283. the federal and state role in mental health, supra note 41. 284. alegria et al., supra note 241. 285. khullar & chokski, supra note 145. 286. id. 287. campo-castillo & anthony, supra note 54. 288. see paying for care, mental health am., https://www.mhanational.org/paying-care [https://perma.cc/lcj7-7sud] (last visited feb.17, 2021). 289. id. 290. id. 291. patient protection and affordable care act of 2010, pub. l. no. 111-148, 124 stat. 119 (2010). 292. alegria et al., supra note 241. 452 indiana health law review [vol. 19:427 attend to basic social needs.”293 people of color do not only lack accessibility to mental health care, but also accessibility to other social programs, such as housing, employment, and other health care services.294 more people of color will seek out these programs if they are all available at the same place rather than having to take the time to seek out each service individually.295 not to mention, there is a stigma around seeking mental health treatment among people of color.296 by seeing these resources readily available with other programs that do not have a stigma around them could encourage people of color to seek mental health treatment that they normally would not pursue.297 providers, as well as community leaders should be encouraging their patients and residents to seek mental health care. many people of color, especially those living in poverty, are unaware of the mental health resources that are available to them.298 eliminating provider discrimination will not have an effect if they are not treating patients who are people of color.299 along with the proper discrimination training, providers should also be educated on how to effectively reach people of color and successfully persuading them to seek mental health care.300 one recommendation to increase the number of people of color who seek mental health treatment is to establish patient and family boards.301 these boards should include a diverse group of members who can report feedback on initiatives that are in place to reduce disparities and offer solutions to resolve any remaining disparities.302 people of color who see that their disparities are being acknowledged and are in the process of being solved by a diverse board of members are more likely to seek treatment from those facilities.303 iv. conclusion mental health care has grown exponentially in recent decades.304 more people are seeking treatment and society is recognizing mental health conditions and the importance of accessible mental health care.305 more insurance providers are providing coverage for mental health services, and government officials are actively working toward making mental health services accessible for all.306 293. id. at 8. 294. id. 295. id. 296. id. 297. id. 298. id. 299. id. 300. id. 301. id. 302. id. 303. id. 304. underserved populations least likely to use telehealth options, supra note 9. 305. id. 306. the federal and state role in mental health, supra note 41. 2022] racial disparities in mental health treatment 453 however, there are many racial disparities in mental health treatment, which have been aggravated by the coronavirus pandemic.307 mental health services are not as accessible due to stay-at-home orders and business closures, and more people are suffering from mental health conditions due to stressors brought on by covid-19.308 mental health care providers continue to discriminate against people of color when administering treatment, greatly affecting the outcomes.309 the united states has failed to eliminate the racial mental health disparities and has offered very little legislation to work toward doing so.310 indiana, like many other states, has failed as well.311 indiana offers one piece of legislation about racial mental health disparities, with no requirements to improve or develop policies to eradicate the disparities.312 legislation, pressure from the public, and educating people of color on the resources currently available are imperative in solving the issue of racial disparities in mental health treatment.313 it will be a long process to resolve the decades of systematic racism that has been instilled in the u.s., but there are many solutions that have been recommended that need to be implemented to begin the process.314 307. racism and mental health, supra note 4. 308. panchal et al., supra note 6. 309. fiske, supra note 15. 310. the federal and state role in mental health, supra note 41. 311. id. 312. ind. code § 12-21-7-1 (2020). 313. alegria et al., supra note 241. 314. id. indiana health law review volume xv 2018 number 1 articles the new health care federalism on the ground abbe r. gluck & nicole huberfeld * i. introduction the central question posed by this symposium concerns the methods of evaluating health policy. our empirical work on that topic centers on american health care federalism, the relationship between the federal and state governments in the realm of u.s. health care policy and regulation. we recently completed a five-year study tracking implementation of the patient protection and affordable care act (aca) from 2012-2017. the study focused on the two key pillars of1 the aca, which also happen to be the most state-centered aspects of the law. those pillars are the expansion of medicaid—the u.s. health insurance program for low-income individuals, originally established in 1965—and the implementation of the aca’s new insurance marketplaces, known as “health insurance exchanges.” our results shed light on what we call the “new health care federalism”—federalism in the modern era of nationally enacted health laws that preserve key roles for state leadership. at the same time, our study reveals the theoretical and empirical challenges of quantitatively evaluating health care federalism at all. what is it really? does it exist? it is successful? why do we choose federalism-oriented models in the first place? the full study and its implications are presented in a forthcoming article in the stanford law review . our purpose here is to offer a more accessible2 snapshot; to discuss the methodological challenges we faced; and to offer in more detail than the longer article one aspect of our methodology: interviews of approximately twenty high ranking former state and federal officials who were at the forefront of the first years of aca implementation. what we heard from * professor of law and faculty director, solomon center for health law and policy, yale law school; professor of health law, ethics & human rights, boston university school of public health & professor of law, boston university school of law. we are deeply thankful to our interviewees for their insights, candor, and time, and to our colleagues in the indiana health law program for the invitation. 1. we began the work of studying implementation with colleagues at the university of pennsylvania, tom baker and theodore ruger, in a project we detail in the stanford law review. we are indebted to them for their contributions. 2. abbe r. gluck & nicole huberfeld, what is federalism in health care for?, 70 stan. l. rev. _ (forthcoming 2018). http://doi.org/10.18060/3911.0041 2 indiana health law review [vol. 15:1 those officials corroborates our empirical data and substantiates our conclusions about the defining characteristics, from a federalism perspective, of the aca’s implementation in the states. of course, implementation is ongoing and the aca’s politics remain in flux. much of what we observed in our study continues to apply to the current context. the implementation process in the states has been 1) dynamic; 2) pragmatic; 3) negotiated; and 4) and marked by intrastate politics. there have been waves of engagement and estrangement between states and the federal government, and state decisions to participate in the aca’s programs have not been binary, on/off choices. states have moved surprisingly fluidly between models of implementation, and some engaged only partially. states and the federal department of health and human services (hhs) have each been extremely creative, devising new ways—some not contemplated by the statute’s drafters—to regulate together in a manner that would be politically palatable for republican governors who concluded that implementing the aca was in the state’s best interest but at the same time did not wish to appear treasonous to their party by “cooperating” with president obama. intergovernmental negotiations have been constant: states have watched other states extract concessions and generous deals from the federal government, then piggybacked on and one-upped those state efforts in their own negotiations. intrastate politics have also been a central feature throughout, as have state-to-state differences that are often glossed over by federalism theorists who discuss the states as monolithic blocs. governors often had different (usually more pro-aca) policy objectives than state legislators. state insurance commissioners also worked around resistant state officials, including some governors, to implement the statute. at the same time, the aca’s implementation raises deeper questions about health care federalism itself—questions that relate to the methodological question posed by this symposium about evaluating health policy. what, exactly, is health care federalism for? in the context of the aca, it sometimes appears that health care federalism is not about improving health outcomes at all but rather is “federalism for federalism’s sake”—federalism to advance political or constitutional values, such as reserving power to the states in the interest of sovereignty and balance of power—regardless of the effect on health care coverage, cost, quality, or other standard measures of health care policy success. we cannot evaluate federalism—whether it exists, whether it is working—without knowing what its goals are. as it turns out, we were unable to achieve our goal of quantifying the extent of federalism under the aca precisely because of this theoretical haziness. we tried, for instance, to measure how “cooperative” the states were—in line with federalism scholars’ preoccupation with the idea of “cooperative federalism”—only to find that concept largely meaningless in this complex context. some states tried to be dutiful soldiers of the aca but failed to run their own programs; other states rebelled and refused to run their own programs from the beginning. the federal government stepped in for both. were such states equally “cooperative”? were they equally “autonomous”? the same challenges appeared in the context of other metrics, like sovereignty. were the states that accepted federal funds and expanded medicaid more or less sovereign than states 2018] the new health care federalism on the ground 3 that refused? were the states that bargained for innovative waivers to expand medicaid in new ways—for instance, privatizing some of the program—more sovereign than both, or were they weaker capitulators than the states that resisted completely? these questions, we discovered, were impossible to answer. we were left with the sense that federalism functions as both means and end in health care. but tension exists between those functions. we can say more assuredly that the aca’s federalism served state power than we can say that its federalism produced better health policy outcomes, which was corroborated by our interviewees’ insights. the aca’s implementation, like other federal programs before it, reveals that traditional federalism policy goals—like policy diversity and experimentation—can be served as easily by nationalist governance structures as by state-centered ones. consistent with the focus of this symposium3 on “measuring” health care, we believe our study poses a major challenge for the4 field: what is health care federalism for, and on what metrics should its success be evaluated? ii. background both by virtue of its statutory design and the way it has been interpreted by courts and administrators, the aca’s implementation has been a joint effort between the federal government and states. the aca as drafted had many aims, but its primary goal was universal health insurance coverage. it aimed to accomplish that goal through two key mechanisms: expansion of medicaid eligibility to childless adults and creation of more robust individual insurance markets through newly-created exchanges. a. the aca’s federalism design the aca adopts a federalism-oriented structure in its two main components, namely medicaid and the exchanges. but the federalism design of each of those pillars is not the same. and it looks different today than it did when the statute was drafted. medicaid, the public health care program for low-income individuals that is jointly run by states and the federal government, has always been held out as a quintessential example of federalism in administration. medicaid is a centerpiece of the aca and was supposed to be significantly expanded by it to address the absence of health insurance options for low income individuals. as drafted, the aca modified medicaid’s limited enrollment for the “deserving poor” (which in many states, at the time the aca passed, did not include low-income childless adults) by expanding eligibility to all adults under age sixty-five with income up 3. see abbe r. gluck, federalism from federal statutes: health reform, medicaid, and the old-fashioned federalists’ gamble, 81 fordham l. rev. 1749 (2013) (collecting sources on how experimentation has come more easily from state programs within federal law than outside it). 4. indiana health law review symposium: ideology meets reality: what works and what doesn’t work in health law and policy (oct. 21, 2016). 4 indiana health law review [vol. 15:1 to 138% of the federal poverty level (fpl). 5 with respect to the exchanges, these new marketplaces were designed to be state-run. states were given the right of first refusal to operate their own exchanges—something conservative senators demanded—and the federal government was to be a fallback for states that did not do so. the exchanges serve several functions for the private side of the market, particularly, individuals who do not receive insurance at work but rather must find it for themselves. these new marketplaces act as health insurance clearinghouses. they make the sale of insurance more transparent and efficient, allowing individuals and small groups to compare and purchase health plans that all meet certain basic coverage and quality criteria. they also administer federal tax credits to subsidize the purchase of insurance for individuals earning between 100-400% of the fpl. 6 as implemented, however, the aca did not fully effectuate the policy goals of its federalism design. the supreme court’s 2012 ruling on the constitutional challenges to the aca, nfib v. sebelius, largely upheld the law but took issue with the mandatory nature of the medicaid expansion. finding the expansion unconstitutionally coercive for states, the court reinterpreted the expansion as optional. the decision dramatically changed the federalism dynamics of7 medicaid implementation, giving states enormous leverage to negotiate for concessions with a federal administration eager to expand the medicaid program’s eligibility so as to achieve the goal of universal insurance coverage.8 exchange implementation also did not proceed as envisioned from a federalism perspective. the statutory design of the insurance exchange provisions was supposed to be the mirror image of the medicaid expansion. the medicaid expansion was drafted to be universal, a significant federal intervention in historic state choices regarding medicaid eligibility. the exchange provisions, on the9 5. patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 § 2001(a)(1) (2010) (noting that the hcera added a 5% income disregard to the 133% of fpl income level delineated in the aca, raising eligibility to 138% of fpl). see also health care and education reconciliation act, pub. l. no. 111-152, 124 stat. 1029 § 1004(b) (2010)). 6. see pub. l. no. 111-148, tit. ii. 7. nat’l fed’n of indep. bus. v. sebelius, 132 s. ct. 2566 (2012). most of the public focus during the case was on the challenge to the insurance mandate—the requirement in the aca that all individuals become insured or pay a tax. the mandate, which at the time this article went to press had been repealed by the 2017 tax bill, helped to sustain private insurance markets in the face of the aca’s new requirements for the insurance industry. the aca requires insurers to cover individuals at essentially equal rates and regardless of medical risk. these and other major changes to the industry’s business model required a source of new funding, as the industry could no longer profit by discriminating on the basis of health and betting on individual risk. the mandate’s purpose was to add new healthy customers to the insurance risk pool. in nfib, the court upheld the mandate as a valid exercise of the tax power. 8. in reality “near universal” because undocumented immigrants were deliberately excluded from the law’s insurance coverage reforms. nicole huberfeld, the universality of medicaid at fifty, 15 yale j. of health policy, l. & ethics 67, 68 n. 7 (2015). 9. nicole huberfeld, federalizing medicaid, 14 u. pa. j. const. l. 431, 444 (2011). 2018] the new health care federalism on the ground 5 other hand, were designed to be state-led. in the name of federalism, as noted, senate conservatives had rejected the house’s preference for a new nationally-run exchange, and the aca enacted the senate’s preference for state-led exchanges.10 it was widely expected that most states—especially republican states—would run their own exchanges, rather than allow the federal government to take over their insurance markets. the aca provided a fallback if they did not: the federal government would operate the exchanges in those states. as in the case of the medicaid expansion, however, the aca as implemented saw a dramatic change to the expected federalism structure of the exchanges. the republican party intensely politicized aca implementation in ways unforeseen at the time of the enactment. as relevant to the exchanges, refusing to implement a state exchange became an act of political resistance to the obama administration and a litmus test for party loyalty. the ironic result was that the very states that had worried most about federal takeover of insurance markets were the same states that refused to implement the law, thereby triggering the federal fallback provisions, and allowing the creation of a national, federally-run exchange in those states. thus, whereas the aca was intended to strengthen the federal role in medicaid and minimize it in the private insurance context, the actual implementation flipped this structure on its head. the court’s decision in nfib reinvigorated state power to determine whether and how they would participate in medicaid, and that attitude bled into the exchange implementation. the aca built states into its structure for many reasons. some were at least partly political. for example, giving the states leadership over the exchanges made the aca’s federal intrusion into the realm of insurance (traditionally a state function) more politically palatable to senate conservatives. some reasons were more pragmatic, not least that the federal government did not have the capacity to implement the aca alone and had an expert body of health administrators waiting in the states, which long have controlled most aspects of health care and insurance regulation. some reasons were ostensibly policy driven, including a belief in the benefit of local policy variation and experimentation. the flipped federalism dynamics that emerged in implementation complicated these matters and enabled the fluid, negotiated federalism that ultimately has characterized the law. b. measurement methodology we devised a three-track strategy in our effort to measure the aca’s federalism. first, we collaborated with colleagues at the university of pennsylvania who were developing a quantitative database to track the development of the aca’s insurance markets. we added a series of criteria on the medicaid expansion to that project, as well as a series of new federalism10. compare america’s affordable health choices act of 2009, h.r. 3200, 111th cong. tit. ii.a. (as reported by house, oct. 14, 2009), with patient protection and affordable care act, h.r. 3590, 111th cong. tit. i.d.ii. (as passed by senate, dec. 24, 2009). 6 indiana health law review [vol. 15:1 related questions in the insurance arena. second, using publicly available11 sources, including government materials and media, we independently catalogued the details of the implementation of medicaid and the exchanges across the states. we tracked factors ranging from program design, to political party in office, to the legal means—law, executive order, etc.—by which the new programs were implemented in any individual state. finally, to corroborate that the federalism implications we drew from the data were also perceived in the “real world,” we interviewed the implementers themselves—current and former state and federal officials who ranged from state governors to insurance commissioners to highranking members of the obama administration. we also interviewed leaders in major healthcare nonprofit and trade groups that were known to be working closely with state and federal officials on implementation. all interviews took place in 2016, were confidential, and were conducted by phone over the course of an hour. as noted, our efforts to quantify “federalism” as part of the university of pennsylvania project were unsuccessful. but those failures were illuminating themselves, and in large part were the result of observations we drew from our qualitative work. we found ourselves unable to quantitatively measure, for example, the extent to which states retained sovereignty because, in looking at aca implementation, it became clear that so many different potential weights of sovereignty might be used. take for instance, the importance of state law. the centrality of the state lawmaking apparatus is a key feature of state sovereignty. our qualitative study illustrates that states passed tens, if not hundreds, of state laws and regulations to implement the aca. in contrast, states that resisted implementation simultaneously invited in the federal government to use federal law to design and implement the insurance markets within those states. which one of these is more sovereign? how can numerical weights be assigned? we faced the same challenges when we attempted to assign weights for “cooperative federalism.” for example, texas refused to operate its own insurance exchange. oregon tried to operate its own but failed due to technological challenges and fell back on the federal government. as a result, both states have national exchanges—exchanges that are identical from the standpoint of federalism structure—even though oregon tried to be a cooperative partner with the federal government. would both measure equally on a scale of cooperative federalism? could federalism possibly be just a matter of attitude? thus, realizing the terrain was nuanced and lacking in defined parameters, the interviews helped to substantiate the descriptive story. we asked the interviewees questions on topics ranging from how much autonomy the aca gives states, to questions about differences between state and federally run structures; policy variations; state interactions with hhs; and state interactions with one another. 11. hix projects, penn ldi (last visited sept. 24, 2017), https://ldi.upenn.edu/hix/projects [https://perma.cc/rp33-e54g]. the upenn hix 2.0 project, which is no longer active, aimed to construct quantitatively coded datasets to support research on the impact of variations in state health law and policy choices on changes in outcome measures of significance, such as the rate of uninsured citizens, the number of insurers active in a state market, and health insurance prices. 2018] the new health care federalism on the ground 7 our interviewees consistently told us that the topics about which we inquired were central to their experience implementing the law. as one very high-level former federal official said during our interview: “federalism is everything i did.”12 iii. key themes made tangible our forthcoming longer article details the four major themes that emerged from our study of aca implementation. in brief, we found the aca’s federalism to be 1) dynamic; 2) pragmatic; 3) negotiated; and 4) marked by intrastate politics. it does not operate as an on/off switch. states have moved between state and federal exchange models. many announced initial resistance to medicaid expansion only to opt in down the line. these moves, especially in the medicaid context, were marked by states watching and leveraging the successes of other states for their own gains in negotiations with the federal government. implementation across both medicaid and the exchanges also was marked by dramatic state-federal creativity in developing hybrid implementation models that the aca itself did not envision and that we have not seen theorized before. for example, hhs facilitated exchange models that were neither state based nor fully federal in order to accommodate states that wished to retain control over their insurance market without looking like cooperative traitors to the republican party. hhs also conceded on medicaid waivers more than could have been foreseen, for example allowing states to privatize more of the medicaid market or to adopt punitive measures to prevent emergency department misuse, to convince reticent states to expand. the implementation details also underscore the importance of intrastate governance, even within a robust federal statutory structure. each state is a republic of its own, yet “the states” often are discussed as if they are a bloc. state actors have different goals. governors have different positions from legislators, whose ideas are different from state medicaid and insurance commissioners, even when they are all of the same political party. the aca implementation prompted some governors to buck legislators in their own party to take advantage of the medicaid expansion for their citizens, underscoring state officials’ diverse priorities. in the insurance context, some state insurance commissioners, convinced that keeping the exchanges in the state rather than ceding control to the federal government, worked directly with hhs to get around their own governors’ resistance to operating aca insurance markets. these workarounds offer a perfect example of the famous concept of “picket fence federalism” on the ground: state and federal administrators in the same area working together on shared goals, often skipping over the preferences of generalist (including more senior) members of their own governments. 12. telephone interview with former executive branch federal health care official #5 (oct. 6, 2016 11:00 a.m.). 8 indiana health law review [vol. 15:1 a. federalism as the central consideration as one of the most important officials in the obama administration on medicaid policy told us: “federalism is central to how medicaid works, it is not off to the side..” all of the officials we spoke with made clear how dramatically13 the nfib decision had changed the dynamics of implementation. as one state official put it, whereas the “aca was designed to be an incremental federalization of health care” —in the sense that it was intended to be a federal14 (national and universal) expansion of medicaid and enlargement of federal control over state insurance markets—nfib and the aca’s politics made state negotiations a much more central dynamic of implementation. even as initially drafted, the officials told us, the federal government knew that the aca could not have been effectively implemented without the states. as one federal official said: if the legislation was purely federal and federally funded [it] would absolutely have been easier; but the way it played out was more complicated than it had to be because of the supreme court decision about medicaid. that really complicated everything, created extra work and complexity for the federal government. the fact that so many states opted out was not expected in legislation or by the agency, and it produced one of most complicated programs we ever worked on.15 the state policy makers we interviewed consistently praised two key obama administration officials, hhs secretary kathleen sebelius and medicaid director cindy mann, for their state-centered mindsets. “cindy mann was a unique leader,” one told us, “she engaged states and moved them with her; she established state operation calls, she reached out to states to get people talking.”16 another reported: “cindy mann was doggedly determined to protect the medicaid program to make sure it was strong and flourished. she understood the back and forth and the need to let states be as autonomous as she could. it was political and financial realities balanced with [the] highest possible standards.”17 we heard similar praise for secretary sebelius. for example: “sebelius was a governor and really understood the governors’ frustrations. the state legislators’ misunderstandings were clear to her. . . . i was awed at how sebelius treated every state relationship as so important. negotiations on waivers were taken so seriously.” one former governor put it this way:18 sebelius is a hero, she did what she could to get the aca done. her background as a governor made it so she knew what states were dealing 13. id. 14. telephone interview with state policy organization officers #1, 2, 3 & 4 (june 6, 2016, 1:00 p.m.). 15. telephone interview with former executive branch federal health care official #1 (june 21, 2016, 10:00 a.m.). 16. telephone interview, supra note 14. 17. id. 18. telephone interview, supra note 15. 2018] the new health care federalism on the ground 9 with every day. she was very attuned to how states function, we had a great working relationship. that attitude of cooperation filtered down to her underlings.19 b. medicaid we detail in our longer article what we observed, through our tracking data, to be four distinct waves of medicaid expansion, each marked by different features. the most eager states made moves toward expansion before nfib interrupted the aca’s implementation. after nfib, states began a period of watching and waiting. some states wanted to implement beyond the aca’s baseline; others wanted to negotiate their own version of expansion; but all wanted to see what hhs would allow given the aca's still-existing statutory parameters. many prominent negotiations centered on states’ efforts to obtain section 1115 demonstration waiver approvals, through which hhs permits states to deviate from the medicaid act so long as the purposes of the act are furthered and the proposed plan appears budget neutral. demonstration waivers are20 unique to the proposing state and can facilitate—especially in aca-resistant states—a sense that “obamacare” is being rejected and the state has instead implemented its own version of health care reform. 21 1. a primary goal of entrenchment: negotiations and horizontal federalism the interviews confirmed our observations about the four waves of medicaid expansion. they also confirmed the observation we drew from our data about the tension between the federal governments’ motivation to expand medicaid and the substance of what that expansion would look like. the federal officials we interviewed emphasized the pull of the aca’s “goal of universal coverage” on the one hand, and the pragmatic view, on the other, on the part of the federal implementers that the critical short-term goal was to get expansion under way. the view was that short-term malleability would serve the long term goal of universality of health care coverage. in retrospect, it seems those officials were22 correct. as of fall 2017, the entrenchment of the medicaid expansion (in whatever form) and its importance to low-income and vulnerable populations across many red states has proved a powerful barrier against republican efforts under the trump administration to “repeal and replace” the aca. this is not to say the obama administration drew no lines. as detailed in the longer article, while more concessions were made in terms of allowing privatization of the medicaid market and other medicaid features than would have been predicted, the obama administration never capitulated to allow work requirements (something that changed as this article went to press).23 19. telephone interview with former governor (aug. 4, 2016, 12:00 p.m.). 20. 42 u.s.c. § 1315 (2014). 21. telephone interview with former federal executive branch health care officials #2, 3 & 4 (aug. 5, 2016, 12:30 p.m.). 22. huberfeld, the universality of medicaid at fifty, supra note 8. 23. see, e.g., thomas price & seema verma, letter to states, dep’t of health & hum. 10 indiana health law review [vol. 15:1 the key theme here, in addition to policy entrenchment, was negotiation. “medicaid waiver negotiations were intensely a federalism-in-action kind of discussion,” one official said. “they became very one on one, governor versus cms as to what they wanted, needed, and what the guardrails are.” several24 interviewees substantiated our perception that the federal government was under intense pressure to make these deals. “everyone was watching,” one official told us, adding that federal negotiators felt they “could not fail.” 25 other officials emphasized the ways in which states were watching one another, eager to piggyback on concessions received by earlier states and to do better for themselves. our data confirm this account. for example, in a post-nfib wave of medicaid expansion through demonstration waiver, arkansas, iowa, michigan, and pennsylvania negotiated with hhs to expand in rapid succession. the pattern of following one another’s successes is not hard to discern: arkansas openly promoted its negotiations with hhs, which involved the first premium assistance expansion model. iowa announced interest in a waiver soon after26 arkansas did and benefited from arkansas’s application by negotiating for27 servs., (march 2017), https://www.hhs.gov/sites/default/files/sec-price-admin-verma-ltr.pdf [https://perma.cc/27pb-brst]; about section 1115 demonstrations, medicaid.gov, ht tps: / /www.medicaid.gov/medicaid/sect ion-1115-demo/about-1115/index.html [https://perma.cc/jn8s-lxmq] (last visited dec. 14, 2017) (describing cms’s new goal to “[s]upport coordinated strategies to address certain health determinants that promote upward mobility, greater independence, and improved quality of life among individuals”, which translates to work requirements); letter from brian neale, director of the center for medicaid & chip services, department of health and human services, smd: 18-002 re: opportunities to promote work and community engagement among medicaid beneficiaries (jan. 11, 2018), at h t tps : / /www.medicaid .gov/ federal -po l icy-gu idance/downlo ad s / smd 1 8 00 2 .pdf [https://perma.cc/tfp3-v5xg]. 24. telephone interview, supra note 12. 25. telephone interview, supra note 15. 26. see robert pear, states urged to expand medicaid with private insurance, n.y. times (mar. 21, 2013), http://www.nytimes.com/2013/03/22/us/politics/states-urged-to-expand-medicaidwith-private-insurance.html?pagewanted=all&module=search&mabreward=relbias% 3ar%2c%7b%222%22%3a%22ri%3a16%22%2c%221%22%3a%22ri%3a7%22%7d [http://perma.cc/ruv6-dxgy]. 27. iowa announced openness to negotiating a waiver on february 26, 2013, see rod boshart, branstad to seek federal iowacare waiver, sioux city journal (feb. 26, 2013), http://siouxcityjournal.com/news/state-and-regional/iowa/branstad-to-seek-federal-iowacarewaiver/article_a5a6b879-66b8-5850-81b7-f6e1364d1296.html [https://perma.cc/b8pa-yxzz]; and intent to pursue a waiver on march 4, 2013, see mike wiser, branstad releases medicaid expansion alternative, sioux city journal (mar. 4, 2013), http://siouxcityjournal.com/ news/local/state-and-regional/branstad-releases-medicaid-expansion-alternative/article_c0ab2c08c443-5f0f-9135-79058fc88bcb.html [https://perma.cc/e2rp-djgc]. arkansas publicized successful conversations with hhs to seek a waiver on february 26, 2013. see david ramsey, update medicaid game-changer, ark. times (feb. 26, 2013), https://m.arktimes.com/arkansas/ blogs/post?basename=medicaid-game-changer-feds-approve-putting-entire-expansion-population2018] the new health care federalism on the ground 11 premium assistance plus other concessions, including enforceable premium payments for individuals earning more than 100% of the federal poverty level, healthy behavior rewards, and copayments for non-emergency use of the emergency department, all of which hhs approved. michigan initiated28 expansion waiver negotiations shortly before arkansas’s waiver was formalized, and like iowa, it sought concessions for cost sharing and healthy behavior incentives, which hhs approved. michigan also created health savings accounts for enrollees’ cost sharing requirements, which arkansas later proposed in an29 amendment to its original waiver. hhs approved michigan’s waiver application30 a few weeks after approving iowa’s. soon thereafter, pennsylvania engaged in negotiations with hhs, originally seeking an arkansas-style premium assistance expansion but later switching to use managed care networks for the newly eligible population—like iowa’s waiver. as one official said:31 states absolutely said i want that plus, or with a variation, just approve my waiver. anything you give to another state you have to assume the next state will come in and ask for that and more. there was a sense on-exchange&day=26&id=arkansasblog&month=02&year=2013 [https://perma.cc/hw4p-v3j7]. 28. see the henry j. kaiser family found., medicaid expansion in iowa (nov. 20, 2015), http://kff.org/medicaid/fact-sheet/medicaid-expansion-in-iowa/ [http://perma.cc/b6dz94nz] (explaining that, although iowa initially required people earning 101-138% of fpl to enroll in its exchange, low insurer participation led the state to offer an option for premium assistance rather than require it). 29. letter from cms admin. marilyn tavenner, to stephen finton, dir. of michigan medical services admin. (dec. 30, 2013) (approving waiver request and state plan amendment for medicaid expansion, including cost sharing for beneficiaries over 100% of fpl and mi health accounts for maintaining cost sharing funds), http://www.michigan.gov/documents/snyder/ heal thy_mich igan _ 1 1 1 5 _ demo n st r a t i on_approval_12302013_443466_7.pdf [http://perma.cc/v4an-pmb6]. 30. michelle andrews, arkansas weighs plan to make some medicaid enrollees fund savings accounts, kaiser health news (july 22, 2014), http://www.kaiserhealthnews.org/ stories/2014/july/22/michelle-andrews-on-arkansas-plan-for-medicaid-savingsaccounts.aspx?utm_campaign=khn%3a+daily+health+policy+report&utm_source=hs_emai l & u t m _ m e d i u m = e m a i l & u t m _ c o n t e n t = 1 3 5 4 3 0 0 6 & _ h s e n c = p 2 a n q t z 9 j f n e w 3 t 7 j y v r m t w h 3 f z 4 r n s m x k 2 9 1 2 7 m l 9 z x m a b 1 0 v e k l 4 w c 5 l k q eamm1opjjgjjdvnwibedtsodynr7cpwdxvsdw&_hsmi=13543006 [http://perma.cc/6qwrcjxg]. see also ark. st. leg., 2015 changes to arkansas’s private option: independence accounts and cost sharing, (june 17, 2014), http://www.arkleg.state.ar.us/assembly/2013/ meeting%20attachments/830/i12552/exh%20%20d%20-privateoption-2015.pdf. [http://perma.cc/bex5-wz5c]. 31. under a new governor (tom wolf), pennsylvania abandoned its expansion waiver instead using expansion envisioned by the aca. see letter from marilyn tavenner, to beverly mackereth, sec’y, pa. dep’t of pub. welfare, approving pennsylvania’s application for a five-year demonstration project (aug. 28, 2014), https://11042-presscdn-0-63-pagely.netdna-ssl.com/wpcontent/uploads/indres/082814healthypaapproval.pdf [http://perma.cc/53x3-kfqa]. 12 indiana health law review [vol. 15:1 among states that the administration was so eager that it was best to be last in line.32 from the state perspective, we heard: “on expansion, the biggest question is what the feds will allow. this played out in arkansas, pennsylvania, etc. states are finding out how much they can get. . . . cost sharing is expensive to administer,” continued the official. “there is no evidence that jobs will make any difference. but there is a political need to drive for these things.” a state official agreed:33 because of the supreme court, the obama administration bent over backward to get states to expand medicaid, permitting demonstrations in some states that may not be beneficial to beneficiaries but that allowed some republican governors to expand when they would not have otherwise . . . [hhs secretaries] burwell and sebelius had the attitude to cover people, even with certain limitations.34 the horizontal state dynamic was not only about one-upping earlier states that had won concessions. we were told that governors share tactics with one another in places where they can talk behind closed doors, such as the national governors’ association meeting, and learned from each other’s successes and failures in implementing the aca. other interviewees noted that the officials35 in charge of the arkansas medicaid expansion were very open in sharing their negotiating tactics with other states. even federal officials were part of the36 horizontal dynamic. cindy mann was singled out by our interviewees for establishing mechanisms for states to share information about medicaid expansion. non-government organizations played critical roles, too, in helping to share information across states. horizontal federalism suffused the medicaid expansion. 2. accountability: pragmatic solutions, masking cooperation, and intrastate dynamics differences across and within states emerged as another key theme that shaped the implementation. states have different mechanisms for implementing a program like medicaid, which also drove how each implemented the aca. as one federal administrator deeply involved in waiver negotiations observed: “state expansion decisions reflect huge interaction with internal state rules; there are glaring institutional differences between states.” 37 while differences between states are important, intrastate differences are just as important, and these kinds of differences have been seriously underplayed in the federalism literature. the aca’s story makes clear how important it is to 32. telephone interview, supra note 12. 33. telephone interview with health policy nonprofit officer #1 (a former state official) (aug. 1, 2016, 10:00 a.m.). 34. telephone interview, supra note 19. 35. id. 36. telephone interview, supra note 33. 37. telephone interview, supra note 21. 2018] the new health care federalism on the ground 13 understand the differences across intrastate actors and how those differences shape interaction with the federal government. governors of both political parties emerged as key partners of the federal government when it came to medicaid expansion. recognizing the impact of resisting the medicaid expansion on state budgets, citizens, and health care businesses, many governors moved to expand even where legislatures of the same party refused. as one former governor put it: the governor represents the entire state and is there to put a vision out for the state and to implement it and to propose legislation to implement. the legislator is from a small district and we can’t get them all going in same direction. the governor has to be the leader of the state, he has to be the one to advocate for a vision for moving a state forward. the legislature is a more reactionary type of body, each legislator comes forth with his own bills but usually on small topics rather than big policy measures.38 a member of a key nonprofit group that assisted with implementation agreed, noting: “the big change was the sense that whatever happens in dc, governors have to run a state and are more practically minded. they have to do a budget, people need coverage, hospitals need money, etc.”39 in some instances, these realignments were fraught. for instance, kentucky governor steve beshear implemented medicaid expansion through an existing kentucky law that commanded medicaid funds to be maximized. the40 legislature argued he could not expand in this manner (administratively and without additional legislative action), but state courts sided with the governor, allowing expansion to proceed. similarly, ohio governor john kasich asked the state controlling board (a state commission that facilitates use of federal funds outside the legislative budgeting process) to approve use of available federal funds for medicaid expansion. the ohio legislature had refused to pass a budget41 that included expansion but was bypassed by the controlling board in conjunction with the governor, and state courts upheld the expansion. in arizona, governor jan brewer would not approve the termination of the legislature’s session until it approved medicaid expansion, strong-arming rather than working around the legislature. and in maine, the legislature continuously passed42 medicaid expansion legislation, only to be thwarted by governor lepage’s vetoes, until the state became the first to expand it by voter referendum. 43 38. telephone interview, supra note 19. 39. telephone interview, supra note 33. 40. ky. rev. stat. ann. § 205.520(3). 41. meeting minutes of the controlling board, ohio office of budget and management (oct. 21, 2013), https://ecb.ohio.gov/public/meetingsandagendas.aspx [https://perma.cc/2anh38ap]. 42. see mary k. reinhart, brewer signs into law arizona’s medicaid program, the republic/azcentral.com (june 18, 2013), http://www.azcentral.com/news/politics/articles/ 20130617brewer-signs-law-arizona-medicaid-program.html [https://perma.cc/46j9-6msh]. 43. patrick whittle, maine oks medicaid expansion in first-of-its-kind referendum, ap 14 indiana health law review [vol. 15:1 at the same time, even governors who pushed implementation—in both parties—were not always eager to take the credit for cooperating with the obama administration. what emerged was a fascinating story about accountability that becomes especially salient in the exchange context, which we detail below. we were told time and again that governors were under pressure to execute waiver deals and come up with versions of medicaid that did not look like “obamacare,” which, we were told, was a “curse word.” further to that point has been the44 practice of renaming and rebranding the state’s version of medicaid with stateassociated names like “tenncare” or “husky health.” states have long used such names for their medicaid programs; they both highlight how state-centered medicaid is, but also conveniently mask these programs’ status as participants in a major federal program.45 one former federal official closely involved with the medicaid expansion described it as follows: “the idea was obamacare is a bad word, we’re not doing obamacare, it’s ‘healthy blank,’ with the state name inserted. this involved rebranding medicaid. charging premiums also falls in this category: it looks more like private coverage, but offers political cover.” another agreed: “there is a46 political dynamic to the desirability of 1115 [waivers]. it makes governors’ offices sound like they are doing something different and has unique political appeal. states love to say they want to evaluate the waiver to sound innovative.”47 this accountability story is interesting for at least two related reasons. on one hand, the rebranding and ownership of state versions of medicaid as programs that the public views as associated with the states and not the federal government contributes to a story of how state implementation of federal statutes can further state autonomy and a sense of state sovereignty. on the other hand, these kinds of efforts can confuse the public and mask political responsibility when programs fail or are undesirable. the seven justices who voted to strike down the mandatory medicaid expansion in nfib focused especially on this argument about obfuscated accountability. we return to this topic in the next part.48 c. exchanges most of the same themes that developed in the medicaid context played out in parallel when it came to the exchanges. as noted, the exchanges developed quite differently from what was expected when the aca was passed. as with other statutes that give states the “right of first refusal” to implement a federal (nov. 8, 2017), https://www.apnews.com/cf007502a8dc421990c4d8dfcde19235/maine-oksmedicaid-expansion-in-first-of-its-kind-referendum [https://perma.cc/zar8-ze2c]. 44. telephone interview, supra note 19. 45. see, e.g., sarah kliff, kentuckians only hate obamacare if you call it obamacare, vox (may 12, 2014), https://www.vox.com/2014/5/12/5709866/kentuckians-only-hate-obamacare-ifyou-call-it-obamacare [https://perma.cc/4bs6-sy4d]. 46. telephone interview, supra note 21. 47. id. 48. nat’l fed’n of indep. bus. v. sebelius, 567 u.s. 519 (2012). 2018] the new health care federalism on the ground 15 program at the state level, the aca’s drafters assumed many states would prefer to run their own exchanges. motivation for doing so includes the federalism value of local variation—being able to tailor the program to the needs of the particular state—but also the view that a federal statute encroaches less on state domains when states control statutory implementation of a federal law. this point was49 emphasized by republicans early in the aca implementation; one republican official said letting the federal government operate a state’s insurance exchange was a “trojan horse” that would pave the way to a full-scale federal takeover.50 but the hot politics of the aca reversed the usual pattern. the paradoxical result was that the most anti-aca states were the same states inviting the federal government to take over their insurance markets. and yet, the story on the ground is much more nuanced. simultaneous with the public resistance and in direct tension with it, many red states quietly have worked under the radar to maintain some policy control, even where the federal government was running the exchange platform in those states. as we detail below, many states have kept these decisions purposefully secret to avoid looking like traitors to the republican party. moreover, whereas on the surface a blue state/red state divide seems to exist in counting which states created their own exchanges, in reality the state-versusfederal-exchange choice has been a landscape as dynamic and adaptive as the medicaid expansion. for example, idaho started as a federal exchange because of difficulties with launching an exchange but soon transitioned to a state-based exchange by piggybacking on efforts of leader states. maryland nearly failed in51 its effort to roll out a state exchange but managed to remain a state-based exchange rather than moving to the federal platform by adopting a state-based platform developed by other states, including connecticut, which was actively trying to sell its model to other states. oregon, as noted, started with its own52 exchange but moved to a federally-supported platform due to technical difficulties. utah split its exchange, putting individuals on a federal exchange and the small group market on a state-based exchange. kentucky was rhetorically opposed to the aca at the national political level and yet implemented one of the most successful state-run exchanges under governor beshear, until his53 49. see generally abbe r. gluck, intrastatutory federalism and statutory interpretation: state implementation of federal law in health reform and beyond, 121 yale l. j. 534 (2011). 50. douglas holtz-eakin, yes to state exchanges, nat’l review (dec. 6, 2012, 12:00 pm), http://www.nationalreview.com/article/334956/yes-state-exchanges-douglas-holtz-eakin [https://perma.cc/d3uw-2wvt]. 51. louise norris, idaho health insurance marketplace: history and news of the state’s exchange, healthinsurance.org (dec. 15, 2017), https://www.healthinsurance.org/idaho-statehealth-insurance-exchange/ [https://perma.cc/3vng-vrc9]. 52. jenna johnson, maryland looks to connecticut for health exchange answers, wash. post (may 31, 2014), https://www.washingtonpost.com/local/md-politics/maryland-looks-toconnecticut-for-health-exchange-answers/2014/05/31/481a7b9c-db83-11e3-800971de85b9c527_story.html [https://perma.cc/hfs9-tfd3]. 53. see, e.g., glenn kessler, what did mitch mcconnell mean when he suggested the 16 indiana health law review [vol. 15:1 successor closed the state-run exchange and switched to the federal platform. one official emphasized how difficult it was to tell the extent of state cooperation merely from the formal structure it had adopted: “across the 25 pure [federal-exchange] states it looks pretty much the same, almost completely the same from the outside, but behind the scenes decisions are more shared than it might appear. like how much plan management is done by the insurance department; it is not obvious that a state is doing plan management from looking at it from the pure federal exchange level.” states had great flexibility in both54 types of exchanges. but “autonomy is not quite the word,” said one of the more senior federal officials responsible for exchange implementation. “the aca set55 up new relationships with states.” another official thought that state-run56 exchanges did indeed have “a lot of autonomy.”57 as in the case of the medicaid expansion, there was enormous pressure on the federal administrators not to fail, to do whatever was needed to get the exchanges up and running, regardless of structure, as was detailed by a senior federal official: the perception was that hhs really wanted states to succeed but it was also dealing with its own extreme challenges. the relationship with all states was critical, many people up to highest level held painstaking negotiations with almost every state, but there were different sets of sensitivities and resources for each state, so it was enormously complex. we were blindsided by so many states refusing to establish their own exchanges. every day we were negotiating with a state trying to help, to make them come along. some states might have been hostile publically but not necessarily behind the scenes. hhs was trying to treat each state as an autonomous entity with a unique situation. hhs tried to be flexible.58 we also saw the theme of horizontality emerge in the context of the exchange implementation but differently than in the medicaid context. states here were not trying to one-up one another’s victories; rather, they worked together and learned from one another. some of this cooperation was facilitated by formal networks empowered within the aca itself, such as the national association of insurance kentucky state exchange was ‘unconnected’ to obamacare?, wash. post (may 29, 2014), https://www.washingtonpost.com/news/fact-checker/wp/2014/05/29/what-did-mitch-mcconnellmean -wh en-h esugges t ed th e-ken tu cky-s t a t e -exch an ge-was-unconnectedto obamacare/?utm_term=.00de39db49d3 [https://perma.cc/7cyc-2np3]; say again, senator, aca unkynected?, lexington herald-leader (may 28, 2014) http://www.kentucky.com/opinion/ editorials/article44490792.html [https://perma.cc/bjp3-dmnm]. 54. telephone interviews, supra note 14. 55. telephone interview, supra note 15. 56. id. 57. telephone interview with health policy nonprofit officer #1 (a former state official) and #2 (aug. 1, 2016, 10:00 a.m.). 58. telephone interview, supra note 12. 2018] the new health care federalism on the ground 17 commissioners, which was given an explicit role in the statute. others were59 more informal, such as a technical assistance network facilitated by the robert wood johnson foundation, commonwealth fund, and milbank. a high level60 official from another major health care nonprofit said she essentially “was running a state to state technical assistance program.” 61 still other forms of horizontal cooperation emerged from the early appearance of “leader states”—states that had successfully implemented exchanges and were serving as models for others. connecticut’s entrepreneurial exchange leader told us that connecticut officials “realized they had invented a better mousetrap,” and that they could “package their services and expertise and make them available to other states.” connecticut exchange leaders promoted their system as giving62 other states “the benefits of a state-based marketplace without the headaches of building or staffing it,” and argued that they can “package [their] services and expertise and make them available to other states, promoting collaboration and avoiding a duplication of effort.” perhaps most interestingly, serious horizontal63 state networking was facilitated by the federal government itself. state and federal officials we interviewed commended cms for facilitating “learning collaboratives” to enable state success in implementation. these collaboratives,64 which have helped states avoid the unnecessary cost and time that would be involved with reinventing the wheel, were not written into the aca but rather are a pragmatic invention by its administrators. 1. accountability and creativity redux: intrastate politics and hybrids as in the case of the medicaid expansion, conflicts among intrastate actors were major obstacles to the establishment of some state-based exchanges. three states’ executives—kentucky, new york, and rhode island—worked an end run around recalcitrant legislatures and created state-based exchanges through executive authority. in other states, governors and insurance commissioners,65 eager to retain control over insurance but facing the wrath of their political party, sought creative workarounds to mask their cooperation with the federal government. hhs was an active partner in these pragmatic negotiations. hhs produced two new insurance-exchange structures not initially envisioned by the 59. see patient protection and affordable care act of 2010, pub. l. 111–148, § 1311(c)(1)(f), 1321(a)(2), 1333(a)(1), 1341(b)(1). see also christine h. monahan, safeguarding state interests in health insurance exchange establishment, 21 conn. ins. l. j. 376 (2015) (describing some of the naic’s efforts). 60. see, e.g., st. health reform assistance network, robert wood johnson found., http://statenetwork.org/ [https://perma.cc/p927-ng7m] (last visited oct. 11, 2017). 61. telephone interview, supra note 58. 62. kevin counihan, ceo, access health ct, panelist at the yale law school health insurance exchange implementation conference, cooperative federalism panel (feb. 8, 2014). 63. robert pear, connecticut plans to market health exchange expertise, n.y. times, (feb. 24, 2014), http://www.nytimes.com/2014/02/25/us/connecticut-plans-to-market-health-exchangeexpertise.html [https://perma.cc/fj26-d9gf]. 64. telephone interview, supra note 12. 65. id. 18 indiana health law review [vol. 15:1 law to accommodate states seeking cover for cooperation. hhs developed these new concepts in administrative guidance documents, calling them “hybrid” and “partnership” exchanges. 66 these new types of exchanges blend state and federal management functions and come in many different forms. as one high-level federal interviewee told us, hhs was able to get seven states—arkansas, delaware, illinois, iowa, michigan, new hampshire, and west virginia—to come on board by giving them more than the binary state-versus-federal choice set forth in the aca. these states wanted to remain in control over policy but still use the federal government for as much technical and practical support as necessary. in our longer article, we call these hybrids “federalism by necessity.” some states needed more political cover. one problem was rhetorical. the original version of the blended exchange model was called “partnership,” and some states did not want to appear to be in “partnership” with the obama administration. another problem was the intrastate political arena. some67 insurance commissioners and other lower state officials wanted to retain control over state insurance markets, even as some governors and legislatures insisted on public resistance. seven states could not adopt the hybrid model for that reason.68 hhs adapted in response by announcing a new hybrid option called state “plan management” (ditching the politically toxic term “partnership”), which the seven holdout states adopted. plan management exchanges do not require formal gubernatorial approval but rather require only informal communications between the federal government and state insurance commissioners, thereby allowing state insurance officials to get around resistant state capitols. as one former federal official said: policies developed because things were not working as the legislation intended. the sense with exchanges was that [hhs] had to be flexible and pragmatic. it was let’s do what we have to do to make this work. if that meant that the exchange got done, then that was far better than having a state give up. we had to make exchanges and the whole system 66. see timothy jost, implementing health reform: moving forward on exchanges, health aff. blog (jan. 4, 2013), https://www.healthaffairs.org/action/showdopubsecure?doi= 10.1377%2fhblog20130104.026901&format=full [https://perma.cc/s9sa-l6qj] (explaining partnership exchange guidance issued by hhs); see also ctr. for consumer info. & ins. oversight, regulations & guidance, ctrs. for medicare & medicaid servs., https://www.cms.gov/cciio/resources/regulations-and-guidance/index.html#health insurance marketplaces [https://perma.cc/hjg6-hm58] (last visited 12/14/17). 67. cf. elizabeth weeks leonard, rhetorical federalism: the value of state-based dissent to federal health reform, 39 hofstra l. rev. 111, 162 (2011) (“[r]hetorical federalism acknowledges that federalism arguments have political salience aside from earnest concerns about the federal structure.”). 68. kansas, maine, montana, nebraska, ohio, south dakota, and virginia were in this group. see christine h. monahan, safeguarding state interests in health insurance exchange establishment, 21 conn. ins. l. j. 376, 423–24 (2015). 2018] the new health care federalism on the ground 19 work. it was not going to work if certain states or insurers weren’t playing.69 the same official continued: “if a state was publicly anti-aca, behind the scenes they might ask for help. even members of congress who were publically opposed asked the secretary for help.” a former state official observed:70 “administrators’ overarching goals may be different than political goals.”71 scholars of federalism will recognize in this story the phenomenon of “picket fence federalism.” that term is used to describe when administrators at different levels of government may more closely identify with one another in furtherance of their policy goals than they do with their particular sovereign.72 the accountability implications of this story are fascinating. in some cases, state actors were evading accountability for their decisions from even superior state actors, not to mention the public. one former state official told us that similar issues abounded with the federally run exchanges, noting that states were making decisions “behind the scenes” even in exchanges where states had73 ostensibly ceded control to the federal government. 2. the “secret boyfriend” model of state-federal relations the workarounds were pervasive. one senior obama administration official offered the most colorful metaphor for the relationship that emerged from them that we heard—“the secret boyfriend.” political cover is a real thing. . . . we internally joked that some health insurance exchanges were the secret boyfriend model. they couldn’t show it in public that the state partnered with the feds. it is happening in medicaid too, some governors want to use special terminology to gain political cover for medicaid expansion.74 the “secret-boyfriend” model of federal-state relations suggests a relationship one covets but is afraid to show publicly. we suspect this model appears in other domains of law, not just health care. but we have never seen it detailed before, or so aptly described. in the context of the aca, the secret-boyfriend model was an important development that gave states a path to participate in the aca without appearing to do so, allowing them to save face while also helping their citizenry. iv. conclusions our interviewees’ answers were so consistent that we felt no need to interview more key players after a certain point. no matter which person, which 69. telephone interview, supra note 15. 70. id. 71. telephone interview, supra note 33. 72. see roderick m. hills, jr., the eleventh amendment as curb on bureaucratic power, 53 stan. l. rev. 1225, 1227-28 (2001). 73. telephone interview, supra note 14. 74. telephone interview, supra note 21. https://doi.org/10.2307/1229541 20 indiana health law review [vol. 15:1 affiliation, or which role they played, our interviewees corroborated our observations that federalism was the focal point of the implementation of the aca and that the aca’s federalism implementation has been marked by dynamism, creativity, pragmatism, negotiations, and horizontality. and yet, the aca’s implementation also reveals how difficult it is to “measure” federalism. it seems to be everywhere, but it is hard to pinpoint exactly what it is, what it is for, and if it has been successful. in large part, that difficultly stems from the fact that many of the conventional federalism metrics and values are far too simplistic for a modern federal statutory scheme that invites state participation for a variety of purposes. as we detail in the longer article, the most commonly-touted federalism values—cooperation, autonomy, sovereignty, and even policy variation—can be seen in the aca across all of the different kinds of structures, whether state or federal-led. policy variation, for instance, occurred as much within federally-run exchanges as within state-run exchanges. autonomy was exercised as much in medicaid expanding states, as in medicaid waiverseeking states, as in medicaid-resisting states. cooperation, as we have shown, is a meaningless concept. so, to the question posed by this symposium about evaluating policy in health care, with respect to federalism what we can say is: “it depends.” it seems much clearer to us, as elaborated in the longer piece, that the aca’s federalism design has advanced state power than that it has achieved good health policy outcomes. if federalism is best understood as a constitutional/structural value—state power as an end in itself—the aca, especially as implemented, seems to advance it. but a different way we commonly understand federalism is as a means to an end; in other words, why protect and advance state power if it does not serve the public good? when it comes to that perspective, it is not clear that the aca’s state-75 centered components were necessary to achieve good health policy, or even beneficial for it. after all, leaving the medicaid expansion to the states has been at least partially responsible for preventing the goal of universal coverage from being achieved. state-run exchanges did not necessarily do better, in terms of access, choice or cost, than federally run exchanges. when we asked interviewees whether they thought outright national control would be simpler, the answer was often yes. but when we asked them if it could76 be possible, the answer was usually no, for both political and practical reasons. and among state officials, regardless of party, a strong sense exists that state 75. see james madison, the federalist papers no. 45 (c. rossiter ed., 1961) (“it is too early for politicians to presume on our forgetting that the public good, the real welfare of the great body of the people, is the supreme object to be pursued; and that no form of government whatever has any other value than as it may be fitted for the attainment of this object. were the plan of the convention adverse to the public happiness, my voice would be, reject the plan. were the union itself inconsistent with the public happiness, it would be, abolish the union. in like manner, as far as the sovereignty of the states cannot be reconciled to the happiness of the people, the voice of every good citizen must be, let the former be sacrificed to the latter.”) 76. telephone interview, supra note 12; telephone interview, supra note 15; telephone interview, supra note 57. 2018] the new health care federalism on the ground 21 control over health policy is a good thing that needs to be maintained—not only for structural reasons but because they are convinced local control leads to better outcomes, a conclusion our study calls into question and about which we think further empirical work is sorely needed. and so, federalism continues to be baked into health care reform, both as an end and as a means, even as those two inputs often conflict.. as one former federal official observed: “it’s not an accident that we keep coming back to cooperative federalism.”77 our challenge to the health law and policy academy, including ourselves, is to tackle this question of what role federalism is supposed to play in health care and whether it is actually playing that role. federalism scholarship is often criticized for its tendency toward the theoretical, floating free of real-world detail. health law scholarship, on the other hand, tends toward “real world” research—a level of gritty detail often unappealing to constitutional theorists—that nods at federalism but does not deeply evaluate its role in health care. we have attempted to join the two worlds through the interviews relayed in this essay and in our other work. the two vectors of federalism and health policy can work at cross purposes. but we also found that the new health care federalism can make a reform effort work—indeed, make it deeply resilient—even in the face of wholly unexpected political and legal hurdles. 77. telephone interview, supra note 21. mental disabilities and duty in negligence law: will neuroscience reform tort doctrine? jean macchiaroli eggen∗ © 2015 “there is no doubt that in many cases a man may be insane, and yet perfectly capable of taking the precautions, and of being influenced by the motives, which the circumstances demand. but if insanity of a pronounced type exists, manifestly incapacitating the sufferer from complying with the rule which he has broken, good sense would require it to be admitted as an excuse.” oliver wendell holmes, 18811 i. introduction .......................................................... 593 ii. the basics of mental disabilities in tort law .................................................................................... 597 a. intentional torts ........................................................ 598 b. the law of negligence ............................................... 602 c. judicial exceptions to the bifurcated rule ............... 613 iii. mental disability in tort doctrine: is there a role for neuroscience? ....................... 617 a. a very brief look at the advantages and weaknesses of functional neuroimaging ........................................... 618 b. stigma and stereotypes ............................................. 627 c. is tort law ready for neuroscience?: revisiting the policies of the bifurcated rule ....................................... 629 ∗* distinguished professor of law, widener university delaware law school. the author wishes to thank dean andrew klein and professors nicolas terry and jennifer drobac of the robert h. mckinney school of law of indiana university, professor tracy gunter of indiana university school of medicine, and the many others involved in the planning of the symposium on “neuroscience and law: injury, capacity and illness” for bringing her into the fold of the neurolaw community and for providing a stimulating environment for the interdisciplinary exchange of ideas. the author also wishes to thank holly frey for her research assistance. 1 oliver wendell holmes, the common law 109 (1881). http://dx.doi.org/10.18060/3911.0003 592 indiana health law review vol. 12:2 iv. the evidentiary challenges of applying neuroscience to tort law .................................... 633 a. the intersection of law and science ......................... 634 b. neuroethics and the search for truth in the courtroom ......................................................................................... 635 c. is neuroscience ready for tort law?: moving from the laboratory to the courtroom ......................................... 638 v. a modest proposal with caveats .................. 643 a. a framework for commencing the discourse .......... 644 1. the duty rule for adults with mental disabilities should be consistent with the rule for physical disabilities. ................................................................... 644 2. the unified subjective rule should expressly recognize that many mental disabilities are organic in nature. 644 3. to be considered in determining liability, the mental disability must be “significant and objectively verifiable.” .................................................................... 645 4. all expert evidence of mental disabilities, including all neuroscience evidence, will be subject to the applicable rules of evidence. ....................................... 645 5. there should be no new defense for persons with mental disabilities. ...................................................... 646 6. existing privileges and defenses that involve mental conditions should remain in effect. ............................. 646 b. some caveats ............................................................. 647 1. courts should be cognizant of the limitations of the technology. ................................................................... 647 2. courts should take care to apply the same evidentiary scrutiny to neuroscientific evidence as to other expert evidence, no more and no less. ............... 648 vi. conclusion ............................................................. 649 2015 will neuroscience reform tort doctrine? 593 i. introduction tort doctrine is replete with mental states, some of which represent arbitrary policy decisions on complex matters, including mental disabilities.2 the traditional premise for tort liability is fault, or “blameworthiness” in the words of holmes,3 and the broadest categories of torts— intentional torts and negligence—define fault in the context of mental states. thus, for a defendant to be at fault, the defendant must make a decision to act in a certain manner that creates a specific risk of harm to the plaintiff’s person or property. generally, tort doctrine imposes the same set of rules on all actors, but allows subjective consideration of certain characteristics of the actor, such as physical disabilities or the age of a child, to be applied when determining liability. one conspicuous exception is mental disabilities in negligence law, on which torts doctrine imposes an objective standard, holding persons with mental disabilities to the same duty standard as persons without such disabilities. some defendants, however, may not have the mental ability to act in a way that constitutes legally cognizable “fault.” developments in neuroscience4 over the past two decades have inspired much speculation about the ability of 2 the americans with disabilities act (ada) defines “disability” as “a physical or mental impairment that substantially limits one or more major life activities of such individual.” 42 u.s.c. § 12102(1)(a) (2014). among the activities the ada identifies—in a nonexclusive list—as “major life activities” are “learning, reading, concentrating, thinking, [and] communicating.” id. § 12102(2)(a). this article will use the term “mental disability” in broadly the same way as the ada and, unless otherwise indicated, without reference to the specific cause of the mental disability. this article does not intend, however, to use the term in a way that is consistent in all ways with the ada and the cases that construe it. 3 see brown v. kendall, 60 mass. (6 cush.) 292 (1850); holmes, supra note 1, at 108. 4 this article uses the term “neuroscience” for the broad category of brain science, including the technologies of structural and functional neuroimaging. occasionally, “neuroimaging” or “structural” or “functional” neuroimaging will be used to designate more specific 594 indiana health law review vol. 12:2 neuroscience to identify and understand the brain pathways associated with human behavior and the utility of that information for making normative legal decisions about fault. as a result, neuroscience has become an increasingly seductive adjunct to the law, offering the promise of explaining actors’ decisions, actions, emotions, moral positions, and motivations. tort law, based as it is on human behavior, is an especially fertile area for interest in these developments. commentators have warned, however, that the science is nascent, its utility problematic, and its application to the law conjectural.5 although advancements in functional neuroimaging have accessed the brain in ways previously unimagined and offered data on activity in the brain in real time, it is unclear at present whether neuroscience will be capable of fulfilling the inflated promises. what is apparent, however, is that notwithstanding these concerns neuroscience may have much to offer tort law, both in individual cases and in the reform of tort doctrine. the criminal justice system has begun to take notice of neuroscience in all aspects of the adjudicatory process, from pre-trial through post-conviction,6 but the civil justice system has been slower to embrace the possibilities of neuroscience. the u.s. supreme court in several recent technologies. see generally infra notes 104-09 and accompanying text (identifying the technologies). 5 see, e.g., owen d. jones et al., law and neuroscience, 33 j. neurosci. 17624, 17624-25 (2013) (stating that some of the possible uses of neuroscience in the law are “more theoretical than current,” but recognizing that neuroscience can make important contributions to the law). one writer has stated that using neuroimaging to help resolve legal issues may allow courts “to directly inspect people’s brains and to bypass the filter of their own and other people’s agendas.” nicole a. vincent, neuroimaging and responsibility assessments, 4 neuroethics 35, 38 (2011). 6 see scott t. grafton, has neuroscience already appeared in the courtroom?, in a judge’s guide to neuroscience: a concise introduction 54, 55 (law & neuroscience project & sage ctr. for the study of mind 2011). grafton has referred to the introduction of mitigating evidence in capital cases as the “front line” for testing neuroscience evidence in the courtroom because of the courts’ willingness to admit more evidence for that purpose. see id. http://dx.doi.org/10.1523/jneurosci.3254-13.2013 http://dx.doi.org/10.1007/s12152-008-9030-8 2015 will neuroscience reform tort doctrine? 595 decisions has taken note of advancements in neuroscience to shape criminal law doctrine on the punishment of juveniles. the court referred to the developmental immaturity of the brains of juveniles in these decisions.7 in contrast, tort law follows a splintered and inconsistent approach to mental states, including mental disabilities. although mental disability is a factor in determining the liability of adults and children for intentional torts, it is only considered for children under the law of negligence. furthermore, negligence law imposes a bifurcated rule for adult tortfeasors, according to which physical disabilities of adults are considered in determining liability, but mental disabilities are ignored. this rule continues to be the majority rule despite regular criticism over many decades, not because it is a good rule but because it is a familiar and convenient rule. as a result, there is a longstanding tradition of mixed messages in tort law, created by an illogical set of policy-laden rules. for decades commentators have noted that the bifurcated rule does not comport with modern medical understanding and psychiatric views of mental illness and other mental disabilities.8 neuroscience adds a new dimension to these voices, as new developments in neuroimaging may provide greater insight into the relationship between organic brain function and human behavior. developments in neuroscience invite a fresh examination of the bifurcated 7 see, e.g., alabama v. miller, 132 u.s. 2455 (2012). the court noted that “‘brain science continues to show fundamental differences between juvenile and adult minds,’” and held that mandatory life imprisonment without parole for persons under the age of eighteen was unconstitutional. id. at 2464-65; see also roper v. simmons, 543 u.s. 551, 578 (2005) (referencing neuroscientific studies and holding that the death penalty for persons under the age of eighteen at the time of the capital crime is unconstitutional). 8 see, e.g., robert m. ague, jr., the liability of insane persons in tort actions, 60 dick. l. rev. 211 (1956); william b. hornblower, insanity and the law of negligence, 5 colum. l. rev. 278 (1905); henry j.f. korrell, the liability of mentally disabled tort defendants, 19 l. & psychology rev. 1 (1995); david e. seidelson, reasonable expectations and subjective standards in negligence law: the minor, the mentally impaired, and the mentally incompetent, 50 geo. wash. l. rev. 17 (1981). http://dx.doi.org/10.2307/1108937 596 indiana health law review vol. 12:2 rule to determine whether an alternative rule better serves parties and society in general. tort law is entrenched in the tradition of the common law and has been slow to reflect contemporary advancements and social patterns. thus, resistance to change is to be expected, and change can only come about jurisdiction by jurisdiction and issue by issue. this article takes the position that it is time to begin a reasoned discourse about the possibility of integrating new developments in neuroscience into tort law in ways that can ameliorate, augment, and ultimately transform tort doctrine. the bifurcated rule presents a logical point to initiate this discourse. as neuroscience provides increasing information about the basis of mental illness and other causes of mental disabilities, the traditional bifurcated rule has become an anachronism. ongoing advancements in neuroscience may have the ability to clarify the factual bases underlying the traditional rule and determine whether the rule continues to be justified. in this way, neuroscience may be a useful tool to influence the development of substantive tort doctrine.9 this article begins in part ii with an overview of the role of mental states in intentional torts and negligence. this section first discusses the basic asymmetry between intentional torts and negligence, with intentional torts employing a subjective mental state rule for all adults and children, but with the law of negligence imposing an objective rule for adults with mental disabilities while maintaining a subjective rule for children. this section proceeds to focus on the bifurcated rule in negligence, which establishes a subjective rule for persons with physical disabilities but an objective rule for those with mental disabilities. attention is given to some judicial exceptions that suggest a path toward transforming the traditional 9 for a broad overview of the tort doctrines, the science, and the potential uses of and likely challenges to the introduction of neuroscience in tort cases, see jean macchiaroli eggen & eric j. laury, toward a neuroscience model of tort law: how functional neuroimaging will transform tort doctrine, 13 colum. sci. & tech. l. rev. 235 (2012). 2015 will neuroscience reform tort doctrine? 597 doctrine. part iii then examines the role that neuroscience may be able to play in understanding mental disabilities and, ultimately, duty in tort law. part iv takes a closer look at some of the global challenges to using neuroscience in tort actions and as a vehicle for transforming tort doctrine. this part focuses separately on the law-science distinction, the ethical considerations of using neuroscience in the law, and the evidentiary challenges of moving neuroscience into the courtroom. finally, in part v this article offers a modest proposal for understanding how neuroscience may contribute to eliminating the bifurcated rule in tort law. this proposal is intended as a means to initiate a broader discourse about neuroscience and other aspects of tort doctrine. this article concludes that on balance the bifurcated rule is no longer tenable in the era of neuroscience, and that with appropriate caution neuroscience may play a key role in transforming tort doctrine to allow mental disabilities of all people to be a factor in determining tort liability. ii. the basics of mental disabilities in tort law the long-standing rule in tort law has been that a defendant may not rely on his or her insanity or diminished mental state to escape liability in tort.10 in the early case of williams v. hays, the new york court of appeals held that “[t]he general rule is that an insane person is just as responsible for his torts as a sane person, and the rule applies to all torts,” with specific limited exceptions.11 this rule, the court said, was grounded in several policies. first, as between two innocent parties, the loss must be borne by 10 the second restatement of torts notes that “[t]he rule that a mentally deficient adult is liable for his torts is an old one, dating back at least to 1616 . . . .” restatement (second) of torts § 283b, cmt. b (1965). 11 williams v. hays, 38 n.e. 449, 450 (n.y. 1894). the court indicated that an exception would apply in torts “in which malice, and therefore intention, actual or imputed, is a necessary ingredient, like libel, slander, and malicious prosecution.” id. 598 indiana health law review vol. 12:2 the person who caused the injury.12 second, public policy favors a rule that will encourage the persons with an interest in the estate of a mentally ill person to take measures to prevent the person from harming others.13 and third, such a rule discourages persons from feigning mental illness so as to avoid liability for their tortious conduct.14 although more than a century has transpired since the williams decision, the basic doctrine has not changed.15 indeed, both the second and third restatements of torts reaffirmed its prevalence along with the underlying policy justifications.16 while mental disability is not a defense to or excuse from tort liability in a general sense, courts have sometimes allowed mental disabilities to be considered as one factor among many in determining liability for both intentional torts and negligence. the result, however, has been an arbitrary and fragmented set of rules. a. intentional torts for intentional torts, a plaintiff must show that the defendant satisfies the requirement of intent, which the third restatement of torts defines as a mental state in which “the person acts with the purpose of producing that consequence; or the person acts knowing that the consequence is substantially certain to result.”17 both parts of this definition could be in play when the mental ability of the defendant is an issue. the basic rule, which is subjective in nature, incorporates the need to show that the 12 id. 13 id. 14 id. 15 see, e.g., delahanty v. hinckley, 799 f. supp. 184, 186 (d.d.c. 1992) (“an insane person is liable for compensatory damages for his torts where express malice or evil intent is not a necessary element of the tort. . . . the primary purpose of such a rule is to compensate the victims for their loss.”). 16 see restatement (third) of torts: liab. for physical and emotional harm § 11 (2010); restatement (second) of torts § 283b (1965). 17 restatement (third) of torts: liab. for physical and emotional harm § 1 (2010). 2015 will neuroscience reform tort doctrine? 599 defendant had the mental capability to know that a particular result was substantially certain to occur. a defendant who is mentally ill or otherwise mentally disabled at the time of the tortious act may be held liable, provided that he or she was capable of forming the requisite intent for the particular tort.18 this rule became ingrained in tort law early. in the 1887 case of mcintyre v. sholty, the illinois supreme court held that the mentally ill defendant could be liable in tort under the traditional rule,19 while acknowledging that criticisms of the rule had some legitimacy. the court relied on the weight of the majority rule and stated: “however justly this doctrine may have been originally subject to criticism, on the grounds of reason and principle, it is now too firmly supported by the weight of authority to be disturbed.”20 the court emphasized that because the remedy in tort is “mere compensation,” and not criminal punishment, holding the mentally ill defendant liable would be fair.21 the court also relied on the standard public-policy justifications that would be echoed in williams and in numerous cases for more than a century.22 18 this traditional rule dates back (at least) to the case of weaver v. ward, (1616) 80 eng.rep. 284 (k.b.). see francis h. bohlen, liability in tort of infants and insane persons, 23 mich. l. rev. 9, 31-32 (192425). 19 mcintyre v. sholty, 13 n.e. 239, 240 (ill. 1887) (“it is well settled that, though a lunatic is not punishable criminally, he is liable in a civil action for any tort he may commit.”). 20 id. 21 see id. the court stated: “there certainly can be nothing wrong or unjust in a verdict which merely gives compensation for the actual loss resulting from an injury inflicted by a lunatic.” id. 22 see id.; see also williams v. hays, 38 n.e. 449, 450 (n.y. 1894). these policies included: (1) encouraging family members (i.e. “those interested in his estate”) to be vigilant in supervising the mentally ill person; (2) shifting compensation to the person responsible for the injury rather than burdening the innocent injured person; (3) encouraging appropriate guardianship processes for the mentally ill who may pose a danger to others; and (4) discouraging tortfeasors from fabricating symptoms to avoid liability. mcintyre, 13 n.e. at 240; see restatement (second) of torts § 283b cmt. b (1965). http://dx.doi.org/10.2307/1278950 600 indiana health law review vol. 12:2 because the concept of intent in tort law differs from mens rea in criminal law, the traditional rule may lead to a different result in a tort action than in a criminal prosecution based upon the same incident. this distinction is well-illustrated by polmatier v. russ,23 in which the defendant had been charged in a criminal proceeding with the death of his father-in-law, but was adjudicated not guilty by reason of insanity. in the subsequent civil wrongful death action for the torts of assault and battery, the defendant’s attorney argued that the defendant had been incapable of forming the requisite intent to commit the intentional torts alleged.24 the evidence in both the criminal and civil actions showed that the defendant had been suffering from severe paranoid schizophrenia at the time of the incident.25 the connecticut supreme court applied the traditional subjective rule for intentional torts and held that the record demonstrated sufficient evidence of intent for the defendant to be held liable under the basic rule, stating that “it is not necessary for a defendant’s reasons and motives for forming his intention to be rational in order for him to have the intent to invade the interests of another.”26 the court so ruled notwithstanding the evidence that the defendant had offered various and conflicting irrational reasons for his attack on the decedent.27 as cases such as polmatier demonstrate—and the persistence of the traditional rule in the restatements of torts confirms—the majority rule has held fast. the same rule of intent applies to children. the frequently studied case of garratt v. dailey28 illustrates this rule as it applied to a five-year-old child who had moved a lawn chair just at the moment when the plaintiff attempted 23 537 a.2d 468 (conn. 1988). 24 id. at 469. 25 id. 26 id. at 473. 27 see id. at 472. the court emphasized that the evidence showed that the defendant had made statements to law enforcement and medical authorities “that he intended to punish polmatier and to kill him,” thereby establishing the ability to formulate the intent to commit the torts of assault and battery. id. at 473. 28 garratt v. dailey, 279 p.2d 1091 (wash. 1955). 2015 will neuroscience reform tort doctrine? 601 to sit on it. as a result, the plaintiff suffered serious injuries and brought a battery action against the child defendant. the court defined the main issue in the case as whether the defendant knew with substantial certainty that the plaintiff had been in the act of sitting at the time he moved the chair, thereby having the requisite knowledge that the plaintiff would make contact with the ground.29 the court emphasized that “[t]he only circumstance where [the defendant’s] age is of any consequence is in determining what he knew, and there his experience, capacity, and understanding are of course material.”30 thus, a subjective standard is routinely applied to children in intentional tort cases. the consent privilege may invoke similar issues when the plaintiff argues that he or she was incapable of consenting to an act because of a mental disability. a valid defense of consent has the effect of negating the intent of the defendant to commit the intentional tort.31 as a general rule, for the plaintiff’s consent to bar liability for intentional torts, the plaintiff must only have consented to the act.32 no requirement exists that the plaintiff consent to the resulting harm.33 the mental disability or other incapacity of the plaintiff may render consent ineffective, however. the rules of consent for both adults and children who lack capacity, including intoxicated persons, are similar to the subjective rule for intent. thus, if the plaintiff was capable of understanding the act to which he or she consented and its likely consequences, consent will be legally effective.34 29 id. at 1093. 30 id. at 1094. because the trial court’s findings were not clear, the court remanded for clarification of the findings. id. 31 see dan b. dobbs et al., dobbs’ law of torts § 106 (2d ed. 2014) (discussing the various ways that consent may be manifested by the plaintiff). 32 see hellriegel v. tholl, 417 p.2d 362, 367 (wash. 1966); dobbs et al., supra note 31, § 105. 33 dobbs et al., supra note 31, § 105. 34 see restatement (second) of torts § 892a cmt. b (1979); dobbs et al., supra note 31, § 109 (stating that “mental limitations are not equivalent to incapacity”). the second restatement notes: “if the person consenting is a child or one of deficient mental capacity, the 602 indiana health law review vol. 12:2 in addition, the defendant must have known, or had reason to know, of the plaintiff’s incapacity.35 this rule raises an additional mental state question—the defendant’s actual or constructive knowledge of the incapacity of the plaintiff. whether the defendant should have known could become a complex question, requiring the defendant to be capable of understanding subtle nuances of behavior. b. the law of negligence in contrast to intentional torts, negligence doctrine contains more complex and fragmented rules regarding persons with mental disabilities. although defendants36 have a duty to exercise reasonable care to avoid injury to the plaintiff,37 the parameters of the duty in a particular case are set by the factual circumstances. moreover, certain subjective characteristics of the defendant may be factors in determining duty and breach. both mental and physical disabilities are considered when the actor is a child, along with the child’s age and experience. with regard to adults a bifurcated rule applies, however, according to which consent may still be effective if he is capable of appreciating the nature, extent and probable consequences of the conduct consented to . . . .” restatement (second) of torts § 892a cmt. b (1979). where a law has been enacted to protect children from the harmful effects of consent—such as statutory rape laws—consent will not be effective as a matter of law. see id. 35 see reavis v. slominski, 551 n.w.2d 528, 538 (neb. 1996). in situations where the defendant had no reason to know of the existence of the incapacity, the reasonable appearance of consent, coupled with the defendant’s reasonable belief that the plaintiff consented, suffices to render the consent legally effective. restatement (second) of torts § 892a(2) (1979). 36 this article primarily uses the designations “defendant” or “tortfeasor” when referring to the duty rules in negligence. these terms are intended to encompass the plaintiff when the plaintiff’s contributory or comparative negligence is at issue in the case. generally, the duty of the plaintiff to avoid causing injury to herself parallels the duty of the defendant to avoid causing injury to a third person (the plaintiff). see restatement (third) of torts: liab. for physical and emotional harm § 3 cmt. b (2010). 37 id. § 7 (noting that in exceptional cases a court may impose a noduty rule). 2015 will neuroscience reform tort doctrine? 603 physical disabilities, but not mental disabilities, may be considered in determining duty and breach. the same bifurcated rule applies to plaintiffs who are alleged to have been contributorily negligent in causing their own injuries.38 the bifurcated rule has had a long and dubious pedigree in negligence law.39 in johnson v. lambotte,40 the adult defendant, a hospital inpatient, had been treated without improvement for chronic paranoid schizophrenia. at the time of the accident, and on the date in question in the case, she was receiving frequent high doses of thorazine.41 upon leaving the hospital without being properly discharged, she walked eight blocks, entered an empty car with the motor running, and began driving, whereupon she collided with the plaintiff’s car. she continued on, and another accident occurred in which she was injured.42 in the plaintiff’s 38 id. § 3 cmt. b (“the definition of negligence set forth in this section applies whether the issue is the negligence of the defendant or the contributory negligence of the plaintiff.”). the third restatement of torts: apportionment of liability posits the adoption of comparative negligence principles for intentional torts, with apportionment of liability between parties found to be at fault, including the plaintiff. see restatement (third) of torts: apportionment of liab. § 1 cmt. c (2000). comment c states: “although some courts have held that a plaintiff's negligence may serve as a comparative defense to an intentional tort, most have not. this restatement takes no position on that issue.” id. although the restatement explicitly acknowledges the complexity of the issues involved in allowing the plaintiff’s negligence to reduce her recovery for an intentional tort, it does not attempt to fully analyze or solve those issues. id. for the moment, there does not appear to be a trend toward allowing the comparative negligence of the plaintiff to reduce recovery in an intentional tort case. the third restatement reporters state that most jurisdictions allowing comparative negligence principles for apportionment of fault in intentional tort cases do so only among defendants, not as between the plaintiff and the defendant. id. reporters’ note to cmt. c & cases cited therein. allowing evidence of the plaintiff’s negligence to impact the plaintiff’s recovery in an intentional tort action would likely invoke the rules of duty discussed in this article and would raise the potential for a conflicting set of rules when the plaintiff is mentally disabled. 39 see williams v. hays, 38 n.e. 449, 450 (n.y. 1894). 40 363 p.2d 165, 165 (colo. 1961). 41 id. 42 id. at 166. 604 indiana health law review vol. 12:2 personal injury action, the defendant argued that she should not be held liable because she had no ability to distinguish between right and wrong at the time of the accident and because she had not acted negligently. at trial, the plaintiff recovered a judgment.43 applying the general rule, the colorado supreme court held that the plaintiff could be held liable for her torts regardless of her mental condition and that the standard of care to which she must be held under the law of negligence was the same as a person without her mental condition.44 cases such as johnson impose an objective standard—the reasonable person without mental disabilities—on adults with mental disabilities. the second restatement articulated the reasons for the tenacity of this prevailing rule and cemented its underlying rationales.45 the second restatement relied on four familiar policies in sustaining the viability of the historical rule: (1) the difficulty of distinguishing “mental deficiency” from lesser “variations of temperament, intellect, and emotional balance;” (2) the concern that—and “ease with which”—parties could fabricate symptoms of mental illness for the purpose of escaping liability; (3) requiring persons with mental conditions to compensate the persons they injure if they “are to live in the world;” and (4) encouraging caretakers to prevent mentally challenged family members from doing harm to others.46 43 id. 44 id. 45 section 283b of the second restatement stated: “unless the actor is a child, his insanity or other mental deficiency does not relieve the actor from liability for conduct which does not conform to the standard of a reasonable man under like circumstances.” restatement (second) of torts § 283b (1965). 46 the second restatement’s language reflects outmoded attitudes toward mentally ill or otherwise mentally challenged persons. the rule contains such terms as “mental defectives.” see id. cmt. b(3). and the tone of the language is sometimes insensitive and reflects negative stereotypes. for example, in stating the fourth policy noted in the text, the restatement states: “the belief that their liability will mean that those who have charge of them or their estates will be stimulated to look after them, keep them in order, and see that they do not do harm.” id. cmt. b(4). 2015 will neuroscience reform tort doctrine? 605 this objective rule for adults with mental disabilities contrasts sharply with the subjective rule for persons with physical disabilities. the third restatement states: “the conduct of an actor with a physical disability is negligent only if the conduct does not conform to that of a reasonably careful person with the same disability.”47 this subjective standard allows the particular defendant’s physical disability to be a factor in determining some important aspects of negligence—the nature of the duty owed, the amount of care required under the circumstances, and whether the duty was breached under the circumstances of the case. comment a indicates that for a physical disability to be considered it must be “significant and objectively verifiable.”48 while old age is not in itself a physical disability and would not fit the basic rule, age-related physical disabilities would be treated as any other physical disability under the rule.49 the third restatement continues to espouse the majority bifurcated rule, however, which imposes an objective standard on adults with mental disabilities.50 47 restatement (third) of torts: liab. for physical and emotional harm § 11(a) (2010). 48 id. § 11, cmt. a. 49 id. cmt. c. 50 id. § 11(c) (“an actor’s mental or emotional disability is not considered in determining whether conduct is negligent, unless the actor is a child.”). the rule for mentally disabled persons is also applied to involuntarily intoxicated persons. see id. § 12 cmt c. a person who is involuntarily intoxicated is one who has not been drugged against his or her will. dobbs et al., supra note 31, § 133 n.1. this rule also applies to persons who have not previously engaged in the particular activity involved in the tort, and to persons with poor memories. in contrast, special skills or training are factors that should be considered in determining how the reasonable person with such skills or training would have acted under the circumstances. persons with special skills or training are held to exercise the care that a reasonable person with those skills would exercise—in other words, specialized care which often would mean more care than a person without those skills would exercise. the third restatement states: “if an actor has skills or knowledge that exceed those possessed by most others, these skills or knowledge are circumstances to be taken into account in determining whether the actor has behaved as a reasonably careful person.” restatement (third) of torts: liab. for physical and emotional 606 indiana health law review vol. 12:2 although comment e recognizes the flaws in this traditional rule, the restatement continues to embrace it because of perceived difficulties applying a rule that allows mental disabilities to be a factor. the comment states that “limited or moderate mental disorders” should not be taken into consideration because such conditions do not generally account for a person’s actions and because of the difficulties of evaluating the impact of these conditions on the person’s behavior under the relevant circumstances.51 the american law institute (ali) does not dispute that the more severe mental conditions may have behavioral ramifications, but expresses the opinion that administrative difficulties—such as the “awkwardness experienced by the criminal-justice system in attempting to litigate the insanity defense”— support retaining the bifurcated rule.52 the ali also cites difficulties in determining whether there was a causal connection between the condition and the conduct of the person. finally, the comment emphasizes the deterrent value of holding liable persons within the entire range of mental and emotional disabilities. liability, at least theoretically, would raise questions about the person’s ability “to engage in the normal range of society’s activities.” recognizing that modern social policy favors deinstitutionalization of persons with mental disabilities, making available compensation for their injured victims becomes a preferred goal.53 harm § 12 (2010). clearly the restatement contemplates the exercise of more care—or at least more specialized care—by such persons, not less care. in contrast, the third restatement notes the refusal to allow below-average skills or knowledge to be considered when determining the duty owed. for one thing, “the acquisition of knowledge and skills is a process that is generally within a person’s control.” id. cmt. b. 51 restatement (third) of torts: liab. for physical and emotional harm § 11 cmt. e (2010). 52 id. 53 the comment states: [t]here is nothing especially harsh in at least holding such a person responsible for those harms that the person’s clearly substandard conduct causes. the theory of deinstitutionalization implies that even persons with severe mental disorders can adequately comply with society’s norms; while reality may fall short 2015 will neuroscience reform tort doctrine? 607 more importantly, the third restatement acknowledges the known organic basis for many mental conditions, yet chooses to disregard that fact in endorsing the bifurcated rule. comment e to section 11 states: “to be sure, modern society is increasingly inclined to treat physical disabilities and mental disabilities similarly, and this inclination is supported by the recognition that many mental disabilities have organic causes.”54 nonetheless, the restatement and the courts have reached the perverse conclusion that the legal duties of persons with mental disabilities under negligence law should be different from those of persons with physical disabilities. burch v. american family mutual insurance co.55 is a classic illustration of the bifurcated rule’s contradictions. in burch, the plaintiff was the father of the mentally challenged minor defendant. the plaintiff was injured when he left the defendant sitting in the front seat of his pickup truck with the engine off and the key in the ignition. when the plaintiff was behind the truck, the truck lurched backward, allegedly by a negligent act of the defendant, injuring the plaintiff.56 in the court’s words, the fifteenyear-old defendant was born with “cerebral palsy and mental retardation with autistic tendencies and function[ed] at the cognitive level of a preschooler.”57 the wisconsin supreme court held that the traditional rule barring consideration of the defendant’s mental condition applied in the case.58 the court observed that the of theory, deinstitutionalization becomes more socially acceptable if innocent victims are at least assured of opportunity for compensation when they suffer injury. id. 54 id. 55 543 n.w.2d 277 (wis. 1996). 56 id. at 278-79. 57 id. at 278. 58 id. at 280. the court distinguished a simultaneously issued decision which held that under certain circumstances an institutionalized mentally disabled person will not be held liable in tort to a paid caretaker. see gould v. am. family mut. ins. co., 543 n.w.3d 277, 283 (wis. 1996) (holding that “an individual institutionalized, as here, with a mental disability, and who does not have the capacity to 608 indiana health law review vol. 12:2 defendant’s mental conditions were “physical/organic in nature and have been present since her birth.”59 nevertheless, the court held that the defendant’s mental condition could not be considered in determining whether she breached a duty of care.60 the court noted, however, that the defendant’s mental condition, and her father’s knowledge of the condition, could be taken into consideration in determining whether the plaintiff was contributorily negligent in leaving his daughter in the car with the key in the ignition.61 thus, the court’s application of the traditional rule was doubly perverse in the burch case. first, the court acknowledged the “physical/organic” basis of the defendant’s mental condition, yet steadfastly refused to allow the mental disability to be treated like a physical disability when determining duty and breach of duty. second, the court turned around and allowed the mental condition of the defendant to be considered for purposes of determining whether the plaintiff was contributorily negligent. notwithstanding such inconsistencies, courts often state that they adhere to the bifurcated rule because allowing mental disabilities to be considered would be “one-sided” and would invariably result in a lesser standard of care as a matter of law—and therefore fewer instances of liability— for persons with mental conditions than those with physical conditions.62 physical disabilities may require the actor to exercise more care or less care depending upon the disability and the circumstances. in roberts v. state, a blind defendant collided with the plaintiff in the lobby of a post office.63 the defendant, who operated a concession control or appreciate his or her conduct cannot be liable for injuries caused to caretakers who are employed for financial compensation”); infra notes 94-102 and accompanying text. 59 burch, 543 n.w.3d at 281. 60 this rule was especially harsh considering that the defendant was a minor. 61 burch, 543 n.w.3d at 280 n.4. 62 see restatement (third) of torts: liab. for physical and emotional harm § 11 cmt. e (2010). 63 roberts v. state, 396 so.2d 566, 566 (la. ct. app.), aff’d, 404 so.2d 1221 (la. 1981). 2015 will neuroscience reform tort doctrine? 609 stand in the lobby, was walking down the hall toward the restroom without the use of a cane and without holding his hand in front of him. the plaintiff claimed that the defendant was negligent in failing to use a cane, even though he had the cane available at his concession stand.64 the court upheld the trial court’s dismissal of the action.65 noting that “it is not uncommon for blind people to rely on other techniques when moving around in a familiar setting,”66 the court did not require a blind defendant to use a cane as a matter of law. the record showed that the defendant had undertaken mobility training and had testified that on this particular occasion he relied on his “facial sense” without a cane, which he frequently used in moving around familiar surroundings. the reasonableness of this technique was supported by the testimony of witnesses from the division of blind services.67 the court concluded that he “was acting as a reasonably prudent blind person would under these particular circumstances.”68 roberts suggests, however, that in other circumstances reasonableness would require a blind defendant to use a cane. the reasonableness of the physically disabled person is generally a question of fact for the jury, and the outcome will depend on the detailed interaction of the nature and extent of the individual party’s physical condition compared to the circumstances of the case.69 thus, the presence of a 64 id. at 567. 65 id. at 569. 66 id. at 568. 67 id. at 567-68. 68 id. at 567. 69 see shepherd v. gardner wholesale, inc., 256 so.2d 877 (ala. 1972). the plaintiff in shepherd tripped and fell on a public sidewalk abutting the defendant’s business. id. at 878. the question was the contributory negligence of the plaintiff, a person with a vision impairment due to cataracts. the court stated: while the law requires a pedestrian to make reasonable use of his sense of sight, a person with impaired vision is not required to see what a person with normal vision could see. . . . a person laboring under a physical disability such as defective vision is not required to exercise a higher degree of care to avoid injury than is required of a person under no disability. 610 indiana health law review vol. 12:2 physical disability may in some circumstances require more care than would be required in the absence of the disability, depending upon what the particular physical limitation allows. the third restatement reflects cases such as roberts: “physical disability can both advantage and disadvantage actors at trial . . . . it can advantage the actor by establishing that the actor neither knew nor should have known of dangers that would have been known by others.”70 on the other hand, “persons with particular disabilities can appreciate that some conduct on their part will foreseeably entail a greater risk than the same conduct engaged in by able-bodied persons.”71 when such risks are foreseeable, a person “can be found negligent for not adopting special precautions that can reasonably reduce the special dangers that the actor’s conduct involves.”72 persons with physical id. at 882. the third restatement expands upon this point: with physical disabilities . . . tort law tailors the negligence standard to acknowledge the individual situation of the actor. to this extent, tort law employs what can be called a subjective rather than a fully objective standard of care. of course, the weight to be attached to the subjective fact of disability depends on the contents of the particular claim of negligence. restatement (third) of torts: liab. for physical and emotional harm § 11 cmt.b (2010). this is substantively different from the treatment of mentally challenged persons. 70 restatement (third) of torts: liab. for physical and emotional harm § 11 cmt.b (2010). 71 id. 72 id. the example presented in the third restatement is that of a blind person who is incapable of seeing certain hazards. he or she would not be required to avoid the unseen hazard in the same manner as a fully sighted person. in contrast, a blind person may be required to exercise a greater amount of care under some circumstances, such as traversing unfamiliar territory. see id; see also hosmer v. distler, 541 n.y.s.2d 650 (n.y. app. div. 1989). the hosmer case involved an injured pedestrian hit by a motorist who at the time of the accident was wearing bifocals, wore a left leg prosthesis, and was taking medication for various ailments, including diabetes. the court stated that because he “chose to drive with full knowledge of his disabilities he is to be held to the standard of a reasonable licensed driver [and that he] had the 2015 will neuroscience reform tort doctrine? 611 disabilities are expected only to adopt appropriate safety precautions given the increased risks associated with their physical conditions.73 persons with mental disabilities, by contrast, must adopt any and all safety precautions expected of a person without their mental conditions. a special rule applies to children. when the mentally disabled person is a child, the applicable rule is a fully subjective one whereby the mental disability will be a factor in the duty analysis.74 the second and third restatements of torts are consistent on the duty of children: “a child’s conduct is negligent if it does not conform to that of a reasonably careful person of the same age, intelligence, and experience.”75 very young children are generally deemed to be incapable of negligence.76 logical reasons exist for the additional responsibility of exercising caution to compensate for any increased hazard occasioned by his known disabilities.” id. at 652. 73 restatement (third) of torts: liab. for physical and emotional harm § 11 cmt.b (2010) (“while it is sometimes said that an actor with a disability must adopt precautions that “compensate” for that disability, obviously complete compensation is often impracticable; what is required is the adoption of reasonable precautions such that their safety advantages outbalance their disadvantages and inconveniences.”). 74 see id. § 11(c). section 11(c) provides: “an actor’s mental or emotional disability is not considered in determining whether conduct is negligent, unless the actor is a child.” 75 id. § 10(a); see sherry v. asing, 531 p.2d 648, 661 (haw. 1975) (stating that “[t]he rule in this and a clear majority of jurisdictions is that a minor is required to exercise care appropriate to his age, experience and mental capacity”); restatement (second) of torts § 283a (1965). 76 restatement (third) of torts: liab. for physical and emotional harm § 10(b) (2010) (“a child less than five years of age is incapable of negligence.”); see, e.g., taylor v. armiger, 358 a.2d 883, 889 (md. 1976); mathis v. massachusetts elec. co., 565 n.e.2d 1180, 1184 (mass. 1991). children approaching the age of majority may present a special challenge. in dorais v. paquin, a case involving the question of the contributory negligence of a 17-year-old child, the new hampshire supreme court applied the subjective standard for children on the ground that “[c]hildren generally do not have the same capacity to perceive, appreciate and avoid dangerous situations which is possessed by the ordinary, prudent adult.” dorais v. paquin, 304 a.2d 369, 371 (n.h. 1973). because of the near-majority age of the child in the case, however, the court held that the plaintiff child’s duty to avoid injury 612 indiana health law review vol. 12:2 subjective rule, including that “children are less able than adults to understand risks, to appreciate alternative courses of conduct with respect to risks, and to make appropriate choices from among those alternatives.”77 this rule, along with its underlying policies, applies equally to children of all mental capabilities.78 once the circumstances are proved, the child must demonstrate conformity with the judgment of a reasonable person with the particular mental condition.79 a universally recognized and common exception involves a child engaged in an adult activity, in which case the child will be held to the standard of an adult engaged in that activity.80 an example of the application of the subjective rule to a child is lafayette parish school board v. cormier ex rel. cormier.81 the school board brought suit against the mother of an eleven-year-old special education student, claiming that the student had caused a teaching assistant to suffer emotional distress by pointing a toy gun at her and yelling “bang.”82 the court agreed with the trial court that the student had not breached the applicable duty of care, which was that of “‘a reasonably prudent 11-year-old boy was the same as an adult. the court noted that “[t]he closer a child comes to majority, and the more common and obvious the risk . . . the more likely it is that the youth will be held to the adult standard of care.” id. at 372 (internal citation omitted). but cf. alabama v. miller, 132 u.s. 2455, 2464-65 (2012) (stating that fundamental differences exists between juvenile and adult minds so as to preclude mandatory life imprisonment without parole for persons under the age of eighteen); roper v. simmons, 543 u.s. 551, 578 (2005) (referencing neuroscientific studies in holding that the death penalty for persons under the age of eighteen at the time of the capital crime is unconstitutional). 77 restatement (third) of torts: liab. for physical and emotional harm § 10 cmt. b (2010). 78 id. § 10(a) & cmt c (stating that “any evidence of mental or emotional deficit can be considered”). 79 restatement (second) of torts § 283a cmt. b (1965). 80 see dellwo v. pearson, 107 n.w.2d 859, 863 (minn. 1961); restatement (second) of torts § 283a cmt.c (1965). 81 lafayette parish school bd. v. cormier ex rel. cormier, 901 so. 2d 1197 (la. ct. app. 2005). 82 id. at 1198-99. the record indicated that the student’s challenges were “emotional disturbance” and “impulsive and aggressive behavior.” id. at 1199. 2015 will neuroscience reform tort doctrine? 613 who has the same exceptionalities’” as the student whose conduct was at issue in the case.83 in young v. grant, the subjective standard cut the other way, however. in young, the plaintiffs’ minor daughter was injured riding her bicycle when she was struck by a car driven by the defendant.84 the defendant alleged the contributory negligence of the minor plaintiff, who was ten years old and mentally challenged. the court stated that although questions of fact may have existed, “all of the evidence in the record (and particularly the testimony of her mother . . .) supports the conclusion that she was a competent cyclist and that she appreciated the dangers of city traffic.”85 accordingly, it was not error to conclude, as had the trial court, that she had not exercised the judgment of a reasonable child of her age, intelligence, and experience and was therefore contributorily negligent in the accident.86 the restatement explains that the special rule for children is justified by public concern for their safety and welfare. moreover, the restatement notes that understanding the behavior of children of all ages, experience, and mental ability is within the apprehension of the general public.87 but could not the same arguments be made to justify applying the subjective rule to adults with mental disabilities? the variations in abilities and temperaments of adults with mental disabilities are surely no greater than among children. and predicting the behavior of children with mental disabilities is outside the basic understanding of most members of the public. c. judicial exceptions to the bifurcated rule 83 id., at 1203 (quoting the trial court). 84 young v. grant, 290 so. 2d 706, 707 (la. ct. app. 1974). 85 id. at 710-11. the court stated further that the record indicated that “this child, ten years of age, and having about six years’ experience in handling a bicycle was of sufficient capacity to realize the obvious danger of turning her bicycle into the path of an oncoming automobile only ten feet away from her despite her mentally retarded condition.” id. at 710. 86 id. at 711. 87 restatement (second) of torts § 283a cmt. b (1965). 614 indiana health law review vol. 12:2 some courts have recognized that the bifurcated rule for adults achieves anomalous or unfair results under certain circumstances and have developed exceptions on public policy grounds. the supreme court of wisconsin has been especially active in this respect. in breunig v. american family insurance co.,88 the wisconsin supreme court expanded the “sudden incapacitation” defense in negligence law to encompass at least some mental conditions. in so doing, the court departed from the majority rule which the third restatement states as follows: “the conduct of an actor during a period of sudden incapacitation or loss of consciousness resulting from physical illness is negligent only if the sudden incapacitation or loss of consciousness was reasonably foreseeable to the actor.”89 the defense as so stated applies only when the sudden incapacitation is due to “physical illness,” not mental illness. and liability is foreclosed only if the party could not have reasonably foreseen the onset of the incapacitation. the wisconsin supreme court, however, broadened the rule to encompass sudden mental incapacitation. breunig involved a motor vehicle accident in which the alleged tortfeasor’s insurer argued that its insured could not be found negligent because “just prior to the collision she suddenly and without warning was seized with a mental aberration or delusion which rendered her unable to operate the automobile with her conscious mind.”90 extending the traditional rule, the court held that the jury should have been allowed to consider the evidence of the insured’s mental illness.91 the court stated this broader rule as follows: 88 173 n.w.2d 619 (wis. 1970). 89 restatement (third) of torts: liab. for physical and emotional harm § 11(b) (2010). 90 breunig, 173 n.w.2d at 621-22. 91 on appeal from a jury verdict for the plaintiff, the wisconsin supreme court began its opinion by stating that at the time of the accident, the insured was in the throes of “an insane delusion” that interfered with her ability to drive the automobile as a reasonably prudent person would. id. at 622. the conclusion was supported by the testimony of the insured’s treating psychiatrist, who stated that at the time of the accident she suffered from acute paranoid schizophrenia and 2015 will neuroscience reform tort doctrine? 615 the effect of the mental illness or mental hallucinations or disorder must be such as to affect the person’s ability to understand and appreciate the duty which rests upon him to drive his car with ordinary care, or . . . it must affect his ability to control his car in an ordinarily prudent manner.92 the court saw no valid legal distinction between physical and mental incapacitation that would merit a different result, provided that the incapacitation was unforeseeable.93 this rule implicitly acknowledges that, at least in some tort contexts, a distinction between the mentally disabled person and the physically disabled person is unwarranted. it also suggests that a subjective standard for adult defendants is workable, regardless of whether the disability is physical or mental. gould v. american family mutual insurance co. presented a different set of circumstances that warranted treating mental and physical disabilities the same under the law of negligence. gould involved a plaintiff who was the head nurse of a dementia unit in a health care facility and who was injured by the defendant’s insured, an alzheimer’s patient in the facility.94 the trial court refused to give an instruction that would have required the jury to consider the insured’s mental state, and the jury found the insured one hundred percent negligent.95 the wisconsin had no advance warning that she would be overtaken by a delusion to the extent that she could not operate her automobile. id. at 622-23. the opinion contained nothing that would suggest that the psychiatrist’s testimony included any overt discussion of the physical basis of the insured’s mental illness. 92 id. at 623. 93 one reason the court may have been willing to go the distance in applying the sudden incapacitation defense to a sudden mental disability was that the circumstances logically ruled out the possibility that the insured would have feigned her condition to avoid liability. 94 gould v. am. family mut. ins. co., 543 n.w.2d 282, 283 (wis. 1996). 95 id. at 284. 616 indiana health law review vol. 12:2 supreme court held, however, that where the alleged tortfeasor is institutionalized for a mental disability, and the plaintiff is his or her professional caretaker,96 the defendant’s mental disability must be considered.97 the gould court reasoned that three of the most often invoked policies to support the bifurcated rule failed in the caretaker context.98 first, the court noted that this was not a case between two “innocent” parties requiring that the loss shift to the defendant. rather, the plaintiff could not be considered “innocent” because she was employed as a caretaker, had professional training and held a supervisory position, and was familiar with the insured’s propensity for violent outbursts related to his mental condition.99 second, the threat of liability would have no further deterrent value on those who may be interested in his estate, as his family had already made the ultimate decision to place him in a secure dementia facility.100 third, the notion that a person would feign the symptoms of alzheimer’s disease and undergo institutionalization simply to avoid the possibility of tort liability in the future was “incredible.”101 courts in several other jurisdictions have created a similar exception 96 alternatively, the doctrine of primary assumption of the risk has been successfully invoked in some cases addressing similar factual circumstances. for example, in gregory v. cott, 152 cal. rptr. 3d 304 (cal. ct. app. 2013), aff’d, 331 p.3d 179 (cal. 2014), a claim brought by an in-home caregiver against an alzheimer’s patient was dismissed on summary judgment based upon the defense of assumption of the risk. the court stated the general rule that recovery will be denied to a plaintiff when “‘the nature of the activity involved and the parties’ relationship to the activity [establishes that] the defendant owed the plaintiff no duty of care.’” id. at 307 (quoting neighbarger v. irwin indus., inc., 882 p.2d 347, 351 (cal. 1994)). the court then concluded that a person hired to care for an alzheimer’s patient, whether in the patient’s home or in a care facility, has assumed the risk of injury from the dangerous propensities of the patient. id. at 310. 97 gould, 543 n.w.2d 282 at 287. 98 the court stated: “[w]e conclude that this rule does not apply in this case because the circumstances totally negate the rationale behind the rule and would place an unreasonable burden on the negligent institutionalized mentally disabled.” id. 99 id. at 286-87. 100 id. at 287. 101 id. 2015 will neuroscience reform tort doctrine? 617 to the traditional bifurcated duty rule for the circumstances presented in the gould case.102 such exceptions represent significant, if small, steps toward relieving persons with mental disabilities from the strictures of a bifurcated rule that no longer fits most situations. these exceptions favor a case-by-case analysis of whether the circumstances of an individual case serve the policies underlying the traditional rule. thus, the nature and extent of the alleged tortfeasor’s disability would be a factor or circumstance—along with all the other relevant circumstances—in determining the nature of the duty owed, if any, to the plaintiff. if rejection of the objective standard for persons with mental disabilities is appropriate in some situations, it is reasonable to ask whether the bifurcated rule has any continued viability. does an objective standard for persons with mental disabilities continue to make sense in an era in which neuroscientific technologies are capable of providing more information than ever about the link between the brain and behavior? would a subjective standard—and a unified one for all torts—better serve the interests of mentally disabled parties and society in general? the remainder of this article explores the role that neuroscience may play in answering these questions. iii. mental disability in tort doctrine: is there a role for neuroscience? this article argues that neuroscience provides crucial support for reforming negligence doctrine so as to create a subjective standard for mentally disabled parties in tort actions. neuroscience evidence, when appropriately admitted, may reduce guessing in the courtroom about the relationship between the person’s mental condition and his 102 see colman v. notre dame convalescent home, inc., 968 f. supp. 809, 814 (d. conn. 1997); mujica v. turner, 582 so. 2d 24, 25 (fla. dist. ct. app. 1991); anicet v. gant, 580 so. 2d 273, 275 (fla. dist. ct. app. 1991) (stating that the same rule and exception apply to intentional torts and negligence); creasy v. rusk, 730 n.e.2d 659, 667 (ind. 2000); berberian v. lynn, 845 a.2d 122, 123 (n.j. 2004). 618 indiana health law review vol. 12:2 or her behavior in the circumstances of the case. neuroscience may also play a role in correcting inaccurate stereotypes of the mentally disabled. most importantly, applying a subjective standard that allows neuroscientific evidence to demonstrate mental states would force courts to take a hard look at the policies underlying the bifurcated rule. courts likely will find that information obtained from neuroimaging could eschew an outmoded doctrine based upon obsolete or ineffectual policies. but is neuroscience ready for legal prime time? this is a vigorously debated question. many experts tout the value of neuroimaging studies while cautioning against an overly enthusiastic espousal of studies that may promise more than they can deliver.103 a. a very brief look at the advantages and weaknesses of functional neuroimaging mental disability in tort cases may be explained by both traditional psychiatric diagnosis or by psychiatric diagnosis combined with information obtained from structural and functional neuroimaging. structural neuroimaging, such as the well-known techniques of magnetic resonance imaging (mri) and computed tomography (ct) scans, and neurophysiological techniques such as the electroencephalogram (eeg) have been mainstays in identifying brain abnormalities.104 more recently, functional neuroimaging techniques have been able to provide psychiatrists with additional information about 103 see geoffrey k. aguirre, functional neuroimaging: technical, logical, and social perspectives, in special report: interpreting neuroimages: an introduction to the technology and its limits, hastings ctr. rpt. s8, s8 (mar.-apr. 2014). professor aguirre expressed concern for the use of neuroimaging outside its home discipline: “during its rapid growth, however, neuroimaging has made multiple lateral moves to new areas of intellectual investigation. a feature of this ‘imaging colonization’ is that the method has moved more quickly than the hard-won cautionary experience would recommend.” id. the law is one such new area requiring caution. 104 see generally nancy c. andreasen & donald w. black, introductory textbook of psychiatry 101-15 (3d ed. 2001). 2015 will neuroscience reform tort doctrine? 619 brain function and dysfunction in persons with mental illnesses.105 functional neuroimaging incorporates technologies such as positron emission tomography (pet) scans,106 single photon emission computed tomography (spect) scans,107 and functional magnetic resonance imaging (fmri)108 to observe brain function under certain controlled stimuli.109 105 id. at 116 (“through the extensive application of these functional imaging techniques . . . we have learned a great deal about dysfunctions in neural circuitry that occur in mental illnesses.”). 106 the pet scan involves the use of small amounts of radioactive chemicals that are injected into the subject which allow the technician to observe brain function by detecting the collection of radioactivity in various parts of the brain. the technician then analyzes this activity over time in a series of static images. owen d. jones et al., brain imaging for legal thinkers: a guide for the perplexed, 2009 stan. tech. l. rev. 5, ¶ 14 (2009). 107 the spect scan combines the technology of the cranial computed tomography (ct) scan and the radioactive feature of the pet scan. ct scans use a combination of x-rays and dyes to detect physiological anomalies in the brain. see henry t. greely & anthony d. wagner, reference guide on neuroscience, in reference manual on scientific evidence 747, 762-63 (fed. judicial ctr. & nat’l research council of the nat’l acads eds., 3d ed. 2011). the spect process allows visualization of the flow of blood through the brain’s blood vessels to observe brain function. see id. at 765. like the ct scan, a computer creates cross-sectional images of the brain, which may then be assembled into three-dimensional images. 108 fmri is a variation of the widely used magnetic resonance (mri) technology, which uses a strong magnet and radio waves to obtain detailed structural images of the brain. see what is fmri?: imaging brain activity, u.c. san diego sch. of med., http://fmri.ucsd.edu/research/whatisfmri.html (last visited may 18, 2015). fmri technology examines brain function in real time. the technician determines blood oxygen levels in part of the brain by detecting the activity of iron atoms in the blood. certain distortions in the magnetic field may indicate changes in the brain associated with the particular task in which the subject is engaged. see jones et al., supra note 106, ¶ 18. the underlying physiological principle is that whenever a particular part of the brain becomes active, the small blood vessels in that region dilate, causing more oxygenated blood to rush in. see michael d. fox & marcus e. raichle, spontaneous fluctuations in brain activity observed with functional magnetic resonance imaging, 8 nature revs. neurosci. 700, 701 (2007) (stating that the term “active” refers to the detected oxygen level in a particular region of the http://dx.doi.org/10.1038/nrn2201 620 indiana health law review vol. 12:2 what applicability may these techniques have to tort actions? their potential is substantial. diagnosis of a mental illness or other mental condition has traditionally been made by a psychiatrist who interprets the symptoms presented by the patient in conjunction with any clinical medical tests and determines whether they fall within the accepted professional parameters of a known condition.110 although diagnoses serve a valuable purpose in the law— particularly in medical malpractice litigation111 and in assessment of injury—diagnosis generally is not a prerequisite to a finding of tortious conduct.112 some experts have suggested that functional neuroimaging may provide better information on behavior than reliance solely on psychiatric diagnosis.113 both the psychiatric analysis of mental conditions and the physiological observation of functional brain systems may be applicable to a particular tortfeasor’s conduct. tort law—and much of law brain in response to various stimuli). the analytical process used to detect this function is known as blood oxygen level dependent (bold) contrast. daniel d. langleben et al., true lies: delusions and liedetection technology, 34 j. psychiatry & l. 351, 359 (2006). 109 see andreasen & black, supra note 104, at 115-21. 110 id. at 22-23. 111 id. at 29. 112 see paul s. applebaum, reference guide on mental health evidence, in reference manual on scientific evidence 813, 819 (fed. judicial ctr. & nat’l research council of the nat’l acads. eds., 3d ed. 2011). speaking generally about both civil and criminal law, dr. applebaum stated: “a diagnosis of mental disorder per se will almost never settle the legal question in a case in which mental health evidence is presented. however, a diagnosis may play a role in determining whether a claim or proceeding can go forward.” id. yet, there are studies that have demonstrated a connection between organic brain damage or other brain condition and sociopathic behavior. see dean mobbs et al., law, responsibility, and the brain, 5 plos biol. 0693 (2007), available at http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.0050 103. 113 see lisa t. eyler et al., brain response correlates of decisional capacity in schizophrenia: a preliminary fmri study, 19 j. neuropsychiatry & clinical neurosci. 137, 138 (2007) (stating that “functional imaging may be a better tool for examining sources of variability in decisional capacity than neuropsychological measures alone”). http://dx.doi.org/10.1371/journal.pbio.0050103 http://dx.doi.org/10.1176/appi.neuropsych.19.2.137 2015 will neuroscience reform tort doctrine? 621 generally—focuses on the ability of persons to function in a variety of social situations, both in terms of their capacity to make decisions and their ability to behave in socially and legally acceptable ways.114 thus, theoretically at least, tort law could benefit from information obtained through the techniques of neuroimaging. neuroscience evidence has appeared steadily in criminal law cases in recent decades at all phases of criminal adjudication—pre-trial, guilt, sentencing, and postconviction.115 in state v. marshall, for example, the defendant moved to withdraw his guilty plea to aggravated first degree murder on the ground of incompetency, arguing that the trial court had erroneously declined to convene a competency hearing.116 the court held that the record showed sufficient evidence to call into question the competency of the defendant when he sought to withdraw the plea because there was proof of “long-standing brain dysfunction, with significant atrophy in the temporal and frontal lobes.”117 the neuroscientific evidence included an mri, a spect scan, and an eeg, all of which revealed abnormalities that experts opined were associated with impaired cognitive abilities.118 the court vacated the plea and remanded the case.119 in matters related to sentencing, the u.s. supreme court has weighed in on the value it attaches to neuroscience studies, at least with regard to brain development in juveniles. in roper v. simmons, the supreme court ruled that the eighth and fourteenth amendments to the u.s. constitution prohibit the death penalty for a person under the age of eighteen at the time of 114 see applebaum, supra note 112, at 820. 115 see grafton, supra note 6, at 55. 116 state v. marshall, 27 p.3d 192, 198 (wash. 2001). 117 id. at 199. 118 id. at 197. 119 id. at 200. but see united states v. hammer, 404 f. supp. 2d 676, 723 (m.d. pa. 2005). in hammer, although the court allowed neuroscientific data obtained from mri and pet scans to be considered on the issue of the defendant’s competence, the court ruled that the plaintiff’s expert’s opinion that the defendant was incompetent was not credible. id. at 792-93. 622 indiana health law review vol. 12:2 the capital crime for which he or she was convicted.120 in its opinion, the court favorably referenced the amicus brief of the american medical association, the american psychiatric association, and other professional organizations, which discussed neuroscience studies, including those conducted using fmri, on adolescent brain development. the amicus brief stated: “to a degree never before understood, scientists can now demonstrate that adolescents are immature not only to the observer’s naked eye, but in the very fibers of their brains.”121 the court adopted this view of the juvenile brain and concluded that it rendered the death penalty unconstitutional for juveniles.122 by contrast, neuroscientific evidence in tort cases is scarce, except to prove damages.123 one reason for this may be practical. tort law does not involve incarceration or capital punishment, and thus there is less urgency to obtain and introduce evidence from new technologies which may be 120 roper v. simmons, 543 u.s. 551, 578 (2005). 121 brief for the american medical association et al. as amici curiae supporting respondent, roper v. simmons, 543 u.s. 551 (2005) (no. 03633), at 10. 122 roper, 543 u.s. at 568. more recently, in miller v. alabama, 132 s. ct. 2455 (2012), the court once again gave its attention to the neuroscience of the juvenile brain. the court held that mandatory life imprisonment without parole for persons under the age of eighteen violated the eighth amendment’s prohibition of cruel and unusual punishment, noting that “‘brain science continue[s] to show fundamental differences between juvenile and adult minds.’” id. at 2464 (quoting graham v. florida, 560 u.s. 48, 68 (2010)). referencing the line of cases about punishment of juveniles, the court declared: “our decisions rested not only on common sense—on what ‘any parent knows’—but on science and social science as well.” id. 123 clearly brain scans of various sorts prove useful in tort cases, mostly to identify structural problems, such as fractures, bleeding, or other anomalies. what is more difficult is the task of determining the extent to which a plaintiff may be experiencing pain. see generally adam j. kolber, the experiential future of the law, 60 emory l.j. 585, 608-13 (2011) (discussing the potential role of neuroimaging in compensation for pain in tort); adam j. kolber, pain detection and the privacy of subjective experience, 33 am. j.l. & med. 433, 443-49 (2007) (discussing using neuroimaging techniques to measure pain and suffering). 2015 will neuroscience reform tort doctrine? 623 expensive.124 another reason may be that neuroscience— and any other area of scientific endeavor that seeks to provide a complete explanation of human behavior—may be viewed as antithetical to the social norms inherent in tort law. professor stephen j. morse has stated that criminal law is based on “folk psychology,” which views humans as rational beings and not “mechanical forces of nature.”125 this same general concept lies at the foundation of tort law, and courts resist any model of tort law that views persons as acting without this element of reason and choice.126 but neuroscience need not be so viewed.127 rather, neuroscience may be a means to advance the goals of tort law. this article urges courts to expand their notion of the traditional model of tort law to allow neuroscience to facilitate the accurate resolution of disputes and reform outmoded doctrines. 124 cf. stephen j. morse, neuroimaging evidence in law: a plea for modesty and relevance, in neuroimaging in forensic psychiatry: from the clinic to the courtroom 341, 342 (joseph r. simpson ed., 2012) (stating that the use of neuroimaging in criminal cases appears to be scarce (though precise estimates of its use are difficult because of the propensity for criminal cases to end in plea bargains), in part because of the expense of the technology). 125 see stephen j. morse, determinism and the death of folk psychology: two challenges to responsibility from neuroscience, 9 minn. j.l. sci. & tech. 1, 4 (2008). morse focuses his discussion on responsibility in criminal law, but many of his points ring true for tort law as well. 126 even in the areas of tort law governed by strict liability, defendants have voluntarily chosen to engage in the activity, such as blasting (strict liability for an abnormally dangerous activity), knowing the risk of tort liability. see, e.g., sterling v. velsicol chem. co., 647 f. supp. 303, 315-16 (w.d. tenn. 1986) (strict liability for disposing of toxic waste), aff’d in part, rev’d in part and remanded 855 f.2d 1188 (6th cir. 1988). 127 in speaking of the relevance that neuroscience may have to the law (and to criminal law in particular) professor morse has stated: “the question is whether the new neuroscience is legally relevant because it makes a proposition about responsibility or competence more or less likely to be true. any legal criterion must be established independently, and biological evidence must be translated into the criminal law’s folkpsychological criteria.” stephen j. morse, avoiding irrational neurolaw exuberance: a plea for neuromodesty, 62 mercer l. rev. 837, 841 (2011). 624 indiana health law review vol. 12:2 but courts must also exercise caution. commentators are not in agreement about either the meaning of the information obtained from neuroimaging or the utility of neuroscientific information in determining legal issues.128 indeed, disagreement exists within the neuroscience community on the interpretation of neuroimaging studies.129 one source of skepticism has been the fact that many brain functions are recruited to process the information relevant to the particular task a study subject is engaged in; accordingly, identification of the precise brain processes involved may be speculative. this is particularly relevant to the kinds of normative judgments that the law makes.130 moreover, individual results may vary from the averages employed in interpreting scan data.131 concerns abound over the problems of reproducing results,132 and commentators have warned that the technology of brain imaging has all the hallmarks of an emerging science that has not yet achieved full reliability.133 translating clinical 128 see teneille brown & emily murphy, through a scanner darkly: functional neuroimaging as evidence of a criminal defendant’s past mental states, 62 stan. l. rev. 1119, 1162 (2010); greely & wagner, supra note 107, at 782. 129 see, e.g., brown & murphy, supra note 128, at 1140-41 (stating that in fmri studies there lacks scientific consensus on how to interpret the relationship between the observable bold response and conclusions about the brain activity or mental states of subjects). 130 see oliver r. goodenough & kristin prehn, a neuroscientific approach to normative judgment in law and justice, 359 phil. trans. r. soc’y lond. series b, biol. sci. 1709, 1717 (2005). 131 jones et al., supra note 106, ¶ 33. professors greely and iles have pointed out: “it is . . . possible that two independent subjects will show different patterns of [brain] activation while their behavioral performances are comparable. although subjects perform the same behavioral task, they might employ different strategies, thereby recruiting different neural networks, resulting in different patterns of activation.” henry t. greely & judy illes, neuroscience-based lie detection: the urgent need for regulation, 33 am. j.l. & med. 377, 382 (2007). 132 see william r. uttal, neuroscience in the courtroom: what every lawyer should know about the mind and the brain 55-61 (2009). 133 morse, supra note 124, at 344 (stating that the “neuroscience of cognition and interpersonal behavior is largely in its infancy”); see eggen & laury, supra note 9, at 302-03 (noting that courts are likely to http://dx.doi.org/10.1098/rstb.2004.1552 2015 will neuroscience reform tort doctrine? 625 studies conducted under artificial circumstances may not yet provide optimal—or even minimal—information on the real-world situations that tort cases address. in addition to the problem of reliably applying neuroscientific data to real-world human interactions, neuroscience is incapable of demonstrating what a person was thinking or planning at the time of the alleged tort.134 this historical problem—i.e. the inability of neuroimaging to provide information about brain activity retrospectively— does not mean that neuroscience is useless in tort law, however. a narrowly circumscribed example is the information gleaned from the studies of informed consent among persons diagnosed with schizophrenia.135 those studies focused on the brain activity of the subjects when confronted with a task at the time of the clinical study. because all subjects shared the same mental diagnosis, these studies could yield (1) current and prospective insight into the ability of schizophrenics, in general, to understand informed consent as well as (2) retrospective insight into how the subjects, and others similarly situated, may have acted in the past, provided that evidence of schizophrenia existed at the relevant point in time. but here, too, caution is paramount. any attempt to generalize about a specific treat neuroimaging evidence used in new and unprecedented ways as novel evidence, thereby making admissibility more problematic). 134 see greely & wagner, supra note 107, at 797. the authors offer a somewhat pessimistic view of the utility of neuroscience data in the legal context: [t]he best [neuroscience] may be able to do is to say that, based on your current mental condition or state, as shown by the current structure or functioning of your brain, you are more or less likely than average to have had a particular mental state or condition at the time of the relevant event. id.; cf. elizabeth ford & neil aggarwal, neuroethics of functional neuroimaging in the courtroom, in neuroimaging in forensic psychiatry: from the clinic to the courtroom 325, 327 (joseph r. simpson ed., 2012) (stating that “neuroscientists can explain the neural processes of behavior, but not the presence of intentionality during a criminal act”). 135 see eyler et al., supra note 113, at 141-43. 626 indiana health law review vol. 12:2 event in the past would require expert extrapolation, which may or may not be admissible in court.136 thus, even from the perspective of a nonscientist, it is clear that neuroimaging is not ready to answer many behavioral questions with certainty. efforts to use neuroscience for such varied concepts as lie detection,137 product marketing,138 and emotional distress damages139 are more aspirational than factual at the present time. but this does not mean that neuroscience has no use in the courtroom generally or in tort law specifically. professor martha j. farah has called for a balanced approach to the shortcomings and vulnerabilities of neuroimaging studies. she has pointed to issues in cognitive psychology that neuroimaging studies have in fact been useful in answering.140 she notes—as this article explains more fully in part iv—that concerns about the accurate statistical analyses of brain imaging data are generally no different than concerns about statistical information in other 136 researchers have also noted that human brains simply change over time, and an fmri scan conducted at some point in time after the event under scrutiny (such as a criminal act) does not necessarily allow for a conclusion that the same results would have been seen at the earlier date. jones et al., supra note 106, ¶ 39. 137 see, e.g., daniel d. langleben, detection of deception with fmri: are we there yet?, 13 legal & criminological psychol. 1 (2008); jane campbell moriarty, visions of deception: neuroimages and the search for truth, 42 akron l. rev. 739 (2009); frederick schauer, neuroscience, lie-detection, and the law, 14 trends in cognitive sci. 101 (2010); joseph r. simpson, functional mri lie detection: too good to be true?, 36 j. am. acad. psychiatry & l. 491 (2008). 138 see maggie fox, now scientists read your mind better than you can, reuters (june 22, 2010, 5:00 pm), http://www.reuters.com/article/2010/06/22/brain-readingidusn2214937420100622 (reporting a study showing that fmri scans predicted consumer choices 75% of the time, while consumers consciously predicted their behavior only 50% of the time). 139 see greely & wagner, supra note 107, at 810 (suggesting that such research could become useful in cases involving emotional distress, but noting that the accuracy of current studies in unknown). 140 martha j. farah, brain images, babies, and bathwater: critiquing critiques of functional neuroimaging, in special report: interpreting neuroimages: an introduction to the technology and its limits, hastings ctr. rpt. s19, s23 (mar.-apr. 2014). http://dx.doi.org/10.1348/135532507x251641 http://dx.doi.org/10.2139/ssrn.2165391 2015 will neuroscience reform tort doctrine? 627 disciplines.141 nevertheless close scrutiny of neuroscience, especially when used in non-scientific disciplines such as the law, remains warranted. b. stigma and stereotypes the law is a function of its time and place. tort law has been especially slow to relinquish older concepts of human behavior, which may contribute to lingering and misleading views of persons with mental disabilities. public perceptions of mental illness and other mental disorders often contain negative stereotypes, which may include low intelligence, lack of control, and violent behavior.142 such stereotypes have created a legal stigma that is difficult to overcome. in a study published in 1999, the researchers observed that their results “reflect an underlying negative attitude [of the general public] toward persons with mental health problems, an exaggeration of the impairments or ‘threat’ associated with these disorders, and a startling negativity toward individuals with substance dependence problems.”143 tort law incorporates and perpetuates such stereotypes in subtle and not-so-subtle ways by clinging to legal doctrines such as the bifurcated rule of duty. although public education about the realities of mental disabilities is the primary vehicle for correcting negative stereotypes, it is not unreasonable to ask the law to do its part and reject the adherence to negative stereotypes. neuroscientific evidence of mental conditions could be a step toward correcting inaccurate assumptions and 141 id. at s24. professor farah also cautioned: “as we apply such scrutiny, it is important to distinguish between specific criticisms of particular applications or specific studies and wholesale criticisms of the entire enterprise of functional neuroimaging.” id. at s28. 142 see bernice a. pescosolido et al., the public’s view of the competence, dangerousness, and need for legal coercion of persons with mental health problems, 89 am. j. pub. health 1339, 1339 (1999) (noting, among other things, that mental health law in the united states is based on an assumption that “mental disorders may place a person at increased risk of physically harming himself or herself or others”). 143 id. at 1345. http://dx.doi.org/10.2105/ajph.89.9.1339 628 indiana health law review vol. 12:2 stereotypes about mental illness. the existing legal decisions are replete with archaic and negative terminology about mentally challenged parties.144 neuroscience is poised to provide courts—and by extension the general public—with more accurate information about mental conditions, thereby leading to more accurate results in individual cases. one commentator has suggested, however, that allowing mental health evidence in the courtroom could actually perpetuate the stigma associated with mental conditions, rather than erase it. professor paul s. appelbaum has observed: diagnoses of mental disorders often are perceived to be less reliable and more subjective than diagnoses of other medical conditions. symptoms of mental disorders may be seen as reflections of moral weakness or lack of will, and the impact of disorders on functional abilities may not be recognized, or occasionally may be exaggerated. the potential impact and limits of current treatments are not widely understood. indeed, even the various types of mental health professionals are frequently confused.145 these observations raise the question whether tort law should delve into the mental conditions of alleged tortfeasors at all. would establishing a subjective rule for 144 the language employed in many cases and the restatements contains extreme terminology, such as referring to a mentally disabled person as a “lunatic,” see, e.g., mcintyre v. sholty, 13 n.e. 239, 240 (ill. 1887); or “insane,” see, e.g., johnson v. lambotte, 363 p.2d 165, 166 (colo. 1961). the restatement has grouped all mental conditions under the label “mental defectives.” see restatement (second) of torts § 283b cmt. b(3) (1965). given the age of some of these sources—or the fact that legal doctrines contain similar language, such as the insanity defense in criminal law—some of these terms could be viewed as archaic terminology. but what is not appropriate is that they represent negative stereotypes that have persisted in substantive legal doctrine. 145 appelbaum, supra note 112, at 821 (footnotes omitted). 2015 will neuroscience reform tort doctrine? 629 mentally challenged adult defendants in negligence actions ingrain in the tort system the notion that all persons with mental conditions lack control, harm others and themselves, or worse? would the rule erase stigma or increase stigma? this article has taken the position that more information is superior to mere conjecture and that, on balance, reforming the bifurcated rule to treat mentally disabled adults the same as other adults and children is the better course in the age of neuroscience. c. is tort law ready for neuroscience?: revisiting the policies of the bifurcated rule social policy driven rules always represent a balance of various goals, all of which are beneficial but some of which may conflict in particular circumstances. in tort law, which is heavily driven by social policy, courts are forced to decide which goals to favor over the others. in considering the bifurcated rule in relation to neuroscience, it is appropriate at this juncture to revisit the traditional policy justifications for the rule and reconsider that balance.146 one policy justification for the bifurcated rule has been that if mentally disabled persons are to “live in the world”— i.e. the prevailing social policy in favor of deinstitutionalization—they should compensate those whom they injure.147 those who favor an objective standard for persons with mental disabilities have argued that an objective rule not only protects members of the community but also encourages equal treatment of the mentally 146 in the 20th century, several commentators examined in detail the policies underlying the bifurcated rule and concluded that they are not justified in modern society. see, e.g., korrell, supra note 8, at 27-46; see also other articles cited supra note 8. accordingly, this article will not undertake that level of detailed policy analysis, but instead will add the neuroscience component to the policy discussion. 147 see creasy v. rusk, 730 n.e.2d 659, 664 (ind. 2000) (stating: “it is clear . . . that contemporary public policy has rejected institutionalization and confinement for a ‘strong professional consensus in favor of . . . community treatment . . . and integration into the least restrictive . . . environment.’”). 630 indiana health law review vol. 12:2 disabled in the community.148 there is little proof, however, that tort law’s treatment of mentally disabled persons differently from persons with physical disabilities achieves any of the goals of full assimilation into society.149 indeed, a rule that treats the mentally disabled differently from the physically disabled or children identifies them as different and threatens to prolong the stigma and accentuate the negative stereotypes experienced by them. a second and related policy rationale for the bifurcated rule is the fundamental premise of tort law that the cost of losses should be shifted from the injured party to the person who caused the injury. in many cases, this policy is expressed as the notion that as between two “innocent” parties, the person who caused the injury should pay. a more accurate statement of this policy, and one that is more consistent with tort doctrine, is that the person whose fault caused the injury should pay. the corollary to this statement is that a person incapable of being deemed at fault, whether because of physical or mental disabilities, should not be required to pay for the injury he or she caused.150 although modern tort doctrine incorporates pockets of strict liability,151 the broad categories of intentional torts and negligence are firmly fault-based aspects of tort law. the bifurcated rule ignores the fault basis of tort law for a segment of the population. third, courts have expressed concern that a subjective rule for persons with mental disabilities would encourage others to feign the symptoms of mental disabilities to escape their own tort liability. this policy rationale may have had some force in an era when psychiatric diagnosis functioned without the assistance of technology.152 with the evolution 148 see stephanie i. splane, note, tort liability of the mentally ill in negligence actions, 93 yale l.j. 153, 163-64 (1983). 149 korrell, supra note 8, at 40-41. 150 see holmes, supra note 1, at 109. 151 see, e.g., dyer v. maine drilling & blasting, inc., 984 a.2d 210, 219 (me. 2009) (strict liability for abnormally dangerous activities); burley v. kytec innovative sports equip., inc., 737 n.w.2d 397, 408-09 (s.d. 2007) (strict liability for a product manufacturing defect). 152 see generally andreasen & black, supra note 104, at 7-19 (providing a brief history of scientific psychiatry). http://dx.doi.org/10.2307/796248 2015 will neuroscience reform tort doctrine? 631 of technologies that examine the brain both structurally and functionally and that may be used as diagnostic tools to identify functional impairments in the brain, the possibility of widespread fabrication of symptoms is diminished, though not eliminated. fourth, as the second restatement stated, courts continue to disregard the mental disabilities of adult tort defendants because of the courts’ own difficulties distinguishing clinical mental conditions from “variations in temperament, intellect, and emotional balance.”153 this concern is coupled with a concern for the “unsatisfactory character of the evidence of mental deficiency in many cases” which could lead to inaccuracies.154 in contrast, courts do not express the same concerns about distinguishing variations in physical abilities. modern developments in mental diagnosis and functional neuroimaging are making this distinction increasingly difficult to sustain for mental disabilities. indeed, one value of using functional neuroimaging in conjunction with traditional psychiatric diagnosis may be to achieve more accurate diagnoses and treatments and greater predictability of behavioral abnormalities.155 finally, the restatement has expressed strong concern that abrogating the bifurcated rule will lead to relief from liability for all mentally disabled adults as a matter of law, creating an inequity between physically and mentally disabled persons. the third restatement articulates this rationale: [t]o recognize mental disability as a factor bearing on findings of negligence would be onesided in a way that recognizing physical disability is not. . . . [w]hen the disability is mental or emotional, the disability directly affects the person’s rationality and judgment; because of this, it frequently will be the case 153 restatement (second) of torts § 283b cmt. b(1) (1965). 154 id. cmt. b(2). 155 see andreasen & black, supra note 104, at 116. 632 indiana health law review vol. 12:2 that the law cannot expect the person wisely and appropriately to moderate conduct choices so as to take the person’s disability into account. therefore, in mental-disability cases the law is often unable to implement the balanced approach that it applies to problems of physical disability.156 it is inescapable that application of a subjective rule of duty to mentally disabled persons would result in non-liability more often than use of the same rule for physically disabled persons. the restatement correctly postulates that to the extent that a proven mental disability interferes with the person’s ability to make a reasoned choice to act, he or she would likely not be liable under a subjective rule. this article argues that accepting this result is preferable to the current practice of imposing a version of strict liability on mentally disabled adults by ignoring their mental conditions in negligence cases. implicit in the restatement’s comment is the concern that use of a subjective rule would lead to a doctrinal change—a lesser duty of care for mentally challenged persons that would evolve into an absolute defense upon the mere proof of the mental condition. this feared doctrinal shift is not inevitable, however. in the context of physical disabilities, the third restatement emphasizes that only “significant and objectively verifiable” conditions would warrant consideration in the duty analysis. minor conditions would not be taken into consideration.157 the 156 restatement (third) of torts: liab. for physical and emotional harm § 11 cmt. e (2010). 157 comment a provides: the physical disabilities this section takes into account generally need to be significant and objectively verifiable. for reasons relating to convenience of administration, it is not worthwhile to attempt to take into account disabilities that are minor or not susceptible to objective verification. thus, a person’s claim of being born clumsy would not be regarded as relevant. id. cmt. a. 2015 will neuroscience reform tort doctrine? 633 restatement also emphasizes that “physical disability is neither a ‘justification’ nor an ‘excuse’ for what is otherwise negligent conduct,” but rather “an actor’s significant physical disability should be taken into account in determining whether the actor’s conduct lacks reasonable care.”158 these same qualifications could and should be applied to mental disabilities. with neuroscientific evidence, greater accuracy of diagnosis and understanding of the behavioral implications of a mental condition would become available. accordingly, what is “significant and objectively verifiable” is a standard that could be met with appropriate evidence. thus, the policies advanced in favor of the bifurcated rule do not fully hold up in the era of neuroscience. reforming the bifurcated rule also requires an understanding of the limitations of the evidence—both how it can assist and what it cannot show. the next part addresses the challenges of using neuroscientific information as evidence in a tort action. iv. the evidentiary challenges of applying neuroscience to tort law courts are in the process of expanding their understanding of the mental health and neuroscience evidence presented to them in all types of cases. one indication of this transformation is that both subject areas have been included in the third edition of the reference manual on scientific evidence published by the federal judicial center and the national research council of the national academies.159 still, common sense cautions against allowing the “wow factor” of neuroscience—a series of state-of-the-art technologies with the ability to dazzle courts and juries with colorful images and exciting information—to overtake the legal system.160 undeniably, 158 id. at cmt. b. 159 see appelbaum, supra note 112; greely & wagner, supra note 107. 160 see michael s. gazzaniga, who’s in charge: free will and the science of the brain 190 (2011) (“many neuroscientists worry 634 indiana health law review vol. 12:2 developing an effective interface between the systems of law and science is not an easy task. nevertheless, it is not an impossible task if undertaken incrementally and for constructive reasons, not simply for the sake of seizing the next new idea. if the law proceeds with caution, neuroscience—just as any other area of scientific or technological endeavor—offers great promise for resolving issues in tort law.161 a. the intersection of law and science the integration of science into legal doctrine has been slow to develop because of the seeming incongruity of the two disciplines. science is process based, while the law demands finality. incorporating neuroscientific developments into substantive tort law to explain human behavior necessarily requires an overlay of normative judgments on the ever-evolving background of scientific knowledge and theories.162 the u.s. supreme court has said that “it would be unreasonable to conclude that the subject of scientific testimony must be ‘known’ to a certainty; arguably, there are no certainties in science.”163 science in general, and the scientific method in particular, constitutes “‘a process for proposing and refining theoretical explanations about the world that are subject to further that a scientist who walks into a courtroom, shows a series of brain scans, and says this is why the defendant shouldn’t be held responsible, is overly influential.”); ford & aggarwal, supra note 134, at 332. 161 professor martha j. farah has recently reviewed some of the critiques of the broad use of neuroscience, including those that argue that neuroscience evidence is “overly convincing” and “overly appealing.” she concluded that “[n]one of the criticisms reviewed here constitute reasons to reject or even drastically curtail the use of neuroimaging.” farah, supra note 140, at s28; see also morse, supra note 124, at 345 (“for now, however, the potential of undue influence of images does not seem sufficient to weigh strongly against admissibility.”). 162 see generally goodenough & prehn, supra note 130, at 1710-13 (discussing the philosophical and historical basis of normative thinking in the law). 163 daubert v. merrell dow pharms., inc., 509 u.s. 579, 590 (1993). 2015 will neuroscience reform tort doctrine? 635 testing and refinement.’”164 accordingly, scientific investigation is progressive, and scientific fact is not finite fact, even when consensus is reached. in the words of the supreme court, “[s]cientific conclusions are subject to perpetual revision.”165 as tort law examines human behavior to determine which behaviors are outside the bounds of acceptable norms, thereby leading to tort liability, there is no current consensus about the precise relationship between the structure and function of the brain and normative choices.166 but that does not mean that the brain could not or should not enter the legal conversation. as previously stated, the law accepts the premise that a person’s choices of action are driven by multiple factors, some of which may be due to neural connections and others that are influenced by genes expressing themselves during a person’s lifetime or by the cumulative impact of an individual’s experiences. thus, mere diagnosis of a mental disorder will never be sufficient without biological, experiential, and circumstantial context. layered over these factors are legal norms. courts, and the experts offering evidence, will continue to have difficulty correlating functional imaging findings with actual functional impairment. information about a person’s brain may help to explain the person’s actions, but it does not answer the legal question of liability.167 that is the domain of tort law and its varied rules. b. neuroethics and the search for truth in the courtroom this article has addressed the question whether the existing bifurcated tort rule should be changed. even 164 id. (quoting the brief for the american association for the advancement of science et al. as amici curiae at 7–8). 165 id. at 597. 166 see goodenough & prehn, supra note 130, at 1717; stephen j. morse, brain overclaim syndrome and criminal responsibility: a diagnostic note, 3 ohio st. j. crim. l. 397, 405 (2006). 167 see michael s. gazzaniga, the ethical brain 89-90 (2005) (stating that “ultimately we must realize that even if the cause of an act (criminal or otherwise) is explainable in terms of brain function, this does not mean that the person who carries out the act is exculpable”). 636 indiana health law review vol. 12:2 assuming that the brain will eventually be found to explain all human behavior, neuroethicists have stressed the need for legal institutions to use that information in an ethical way.168 if there is such a concept as neurological determinism, it does not follow that legal determinism or absolute legal rules would or should ensue.169 as neuroscience moves closer to explaining all human perception and behavior in biological terms, it is nevertheless unlikely that the law will relinquish notions of the “self” or the “mind”—in other words human reason and choice.170 tort law is firmly wedded to the latter concepts. the ways in which neuroscience could be used and abused in the legal system are no different from the ways other types of technological and expert evidence may be used and misused. does this mean the legal system should place an absolute bar on neuroscience? this is essentially a moot question because “the genie is already out of the bottle” due to the extensive exposure developments in neuroscience have received beyond the medical 168 martha j. farah, neuroethics: the practical and the philosophical, 9 trends in cognitive sci. 34, 38-39 (2005), available at http://dx.doi.org/10.1016/j.tics.2004.12.001. 169 see gazzaniga, supra note 167, at 101. 170 see morse, supra note 127, at 841. professor morse observed: for the foreseeable future, . . . the law will be based on the folk-psychological model of the person and behavior . . . . until and unless scientific discoveries convince us that our view of ourselves is radically wrong, the basic explanatory apparatus of folk psychology will remain central. it is vital that we not lose sight of this model lest we fall into confusion when various claims based on neuroscience are made. id. some commentators have stated that neuroscience is not incompatible with the notion of free will, but rather will lead to a different understanding of the relationship between the neuroscientific view of the brain and traditional notions of intuition and legal responsibility. see, e.g., adina roskies, neuroscientific challenges to free will and responsibility, 10 trends in cognitive sci. 419, 423 (2006); cf. read montague, how is neuroscience likely to impact law in the near future?, in a judge’s guide to neuroscience: a concise introduction 60, 61 (law and neuroscience project & sage ctr. for the study of the mind eds., 2011) (stating that the gap between cognitive variables and fmri data is “a crucially underdeveloped area of human neuroscience”). http://dx.doi.org/10.1016/j.tics.2004.12.001 http://dx.doi.org/10.1016/j.tics.2006.07.011 2015 will neuroscience reform tort doctrine? 637 community.171 professor martha j. farah has summed up society’s dilemma, stating that the influx of neuroscience information may forge “a more understanding and humane society, as people’s behavior is seen as part of the larger picture of causal forces surrounding them and acting through them. but it could also reduce us to machines in each other’s eyes, mere clockwork devoid of moral agency and moral value.”172 tort law already involves traditional ethical notions of responsibility and fairness,173 making tort law well-positioned to address the need for balance between the organic bases of human behavioral choices and the traditional notions of self and the mind.174 171 see martha j. farah, neuroscience and neuroethics in the 21st century, in the oxford handbook of neuroethics (judy illes & barbara j. sahakian eds., 2011) 761, 771 (stating that “[a]n across-theboard moratorium on non-medical applications of neuroscience would be unfeasible given that the genie is already out of the bottle”). 172 martha j. farah, neuroethics: an introduction with readings 8 (2010). 173 see generally id. at 7 (stating: “it remains to be seen how these developments [in neuroscience] will intersect with our strongly held beliefs about the value of privacy, freedom, fairness, and responsibility. one of the main tasks of neuroethics is to assess the likely impact of neuroscience on these and other moral and cultural ideals.”). 174 the classic example of balancing notions of responsibility against potential adverse outcomes in negligence law was stated by judge learned hand in united states v. carroll towing, 159 f.2d 169, 173 (2d cir. 1947), in which he set forth his famous balancing test for liability, which “depends upon whether b [the burden of taking precautions] is less than l [the injury] multiplied by p [the probability of l occurring]: i.e., whether b less than pl.” professor morse has discussed the need for balance in relation to criminal law: in general, the hope is that over time there will be feedback between the folk-psychological criteria and the neuroscientific data. each might inform the other. conceptual work on mental states might suggest new neuroscientific studies, for example, and the neuroscientific studies might help refine the folkpsychological categories. the ultimate goal would be a reflective, conceptual-empirical equilibrium. morse, supra note 127, at 857. 638 indiana health law review vol. 12:2 c. is neuroscience ready for tort law?: moving from the laboratory to the courtroom the short answer to this question is that courts are not yet ready for a wholesale barrage of neuroimaging and other neuroscience evidence. numerous commentators, both scientists and legal analysts, have expressed this same view.175 this opinion is not just a function of the limitations of neuroscientific data interpretation, but reflects the realities of legal evidence in the courtroom. american courts require that expert evidence, of whatever type, be both reliable and relevant to be admissible. these requirements, regardless of the legal test that applies, are quite rigorous. in the federal courts and other jurisdictions176 that follow the rule of daubert v. merrell dow pharmaceuticals, inc.177 and its progeny,178 technological evidence such as neuroscience must be held reliable under a flexible multi-factored test: whether the technique has been tested, presumably through replication under the rubric of the scientific method; whether the study has been published or otherwise peer reviewed; the known rate of error of the technique; and whether the methodology has been generally accepted in its field.179 although 175 see, e.g., jones et al., supra note 106, ¶ 47; stephen j. morse, the future of neuroscientific evidence, in the future of evidence 137, 142 (carol henderson & jules epstein eds., 2011); marcus raichle, what is an fmri?, in a judge’s guide to neuroscience: a concise introduction 5, 12 (law and neuroscience project & sage ctr. for the study of the mind eds., 2011). 176 see, e.g., e.i. du pont de nemours & co. v. robinson, 923 s.w.2d 549 (tex. 1995). 177 509 u.s. 579 (1993). 178 see kumho tire co. v. carmichael, 526 u.s. 137 (1999) (applying the federal rules of evidence and daubert to all types of expert evidence); gen. elec. co. v. joiner, 522 u.s. 136 (1997) (explaining the relevancy arm of the daubert test). 179 the flexible daubert rule has been codified in the federal rules of evidence, which provide: a witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: 2015 will neuroscience reform tort doctrine? 639 reliability is based on scientific knowledge, the u.s. supreme court has said that the subject of the expert’s testimony need not be known to a certainty.180 other jurisdictions espouse the older frye rule of reliability, requiring more rigidly that the technique must be generally accepted in the relevant field.181 under either test, reliability is a stringent standard.182 the expert evidence must also be legally relevant. as the federal rules of evidence set forth, even evidence otherwise deemed relevant may be excluded if “its probative value is substantially outweighed by a danger of . . . unfair prejudice, confusing the issues, [or] misleading the jury.”183 the supreme court addressed relevance in the context of expert scientific evidence in general electric company v. joiner,184 in which the court stressed that the expert’s opinion must provide a close “fit” to the specific issues in the (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case. fed. r. evid. 702. the advisory committee note adds several factors to this test, including, among other factors: (1) whether the evidence was developed for the specific litigation for which it was offered; (2) whether too much of an analytical gap exists between the data and the expert’s conclusion; and (3) whether the expert considered other theories. fed. r. evid. 702 advisory committee’s note. 180 daubert, 509 u.s at 590. 181 see frye v. united states, 293 f. 1013, 1014 (d.c. cir. 1923). some states continue to follow the frye rule. see, e.g., slay v. keller indus., inc., 823 so.2d 623 (ala. 2001); people v. leahy, 882 p.2d 321 (cal. 1994); blackwell v. wyeth, 971 a.2d 235 (md. 2009); goeb v. tharaldson, 615 n.w.2d 800 (minn. 2000). 182 see jean macchiaroli eggen, clinical medical evidence of causation in toxic tort cases: into the crucible of daubert, 38 hous. l. rev. 369, 375-88 (2001) (discussing daubert and its progeny); jean macchiaroli eggen, toxic torts, causation, and scientific evidence after daubert, 55 u. pitt. l. rev. 889, 909-31 (1994) (discussing frye and daubert). 183 fed. r. evid. 403. 184 522 u.s. 136 (1997). 640 indiana health law review vol. 12:2 case. acknowledging that experts necessarily must extrapolate from data, the court issued a warning that the expert evidence will be inadmissible if it “is connected to existing data only by the ipse dixit of the expert.”185 when the “analytical gap” between the data and the expert’s conclusions is too great, the evidence will not be allowed.186 thus, relevance is not met by merely offering reliable evidence that relates to an issue in the case. the standard is much higher, requiring a direct nexus between the underlying data and the expert’s conclusion and then again between the conclusion and the narrow issue for which it is offered. turning to mental disabilities in tort law, all expert neuroscience evidence offered in support of the positions of the parties to the lawsuit must satisfy the reliability and relevance standards, or it will not see the light of day in the courtroom. these requirements are no different from those applied to any other expert evidence offered in support of an issue in a tort case.187 what exactly does the law expect from neuroscience? this article proposes that the law should expect nothing more from neuroscience than it expects in any case involving expert evidence. to that extent, courts should be open to the introduction of neuroscience evidence. that neuroscience is an emerging technology is no reason to view it as less promising and potentially informative than other types of newer 185 id. at 146. an expert may rely on studies generated by others if the studies are the type reasonably relied upon in the field. fed. r. evid. 703. 186 joiner, 522 u.s. at 146. in joiner, the analytical gap was too great and the evidence had properly been excluded by the trial court. see id. at 145-46; see also o’conner v. commonwealth edison co., 13 f.3d 1090, 1106–07 (7th cir. 1994) (excluding expert testimony that radiation was the cause of the plaintiff’s cataracts because the opinion was merely subjective and did not have a sufficient scientific basis); chikovsky v. ortho pharmaceutical corp., 832 f. supp. 341, 346 (s.d. fla. 1993) (excluding expert testimony that the mother’s use of an acne medication caused the plaintiff’s birth defects because the opinion relied on studies conducted on a drug similar, but not identical, to the drug involved in the case). 187 kumho tire co. v. carmichael, 526 u.s. 137, 147-48 (1999) 2015 will neuroscience reform tort doctrine? 641 technologies, such as dna analysis.188 nevertheless, courts should be attuned to the substantive difference in what is actually known from neuroscience and what the parties merely hope neuroscience can show. from an evidentiary perspective neuroscience evidence will face some formidable challenges in individual cases regardless of the evidentiary standard applicable in the specific jurisdiction.189 neuroscience evidence may be loosely categorized as generalized or specific. generalized evidence may be illustrated by hypothesizing a diagnosed mental condition, such as schizophrenia.190 a diagnosis of schizophrenia in the defendant may provide sufficient information to allow an expert to state that a correlation exists between diagnosed schizophrenics and the type of behavior in issue in the case.191 but this information, without more, does not provide a specific causal connection between the diagnosed mental condition and the behavior of the defendant at the time of the tortious act. in addition to generalized evidence, the party must offer specific evidence, such as structural or functional neuroimaging studies 188 cf. daubert, 509 u.s. at 592 n.11 (stating that “well-established propositions are less likely to be challenged than those that are novel, and they are more handily defended”); greely & wagner, supra note 107, at 787 (noting that neuroscience has not yet “undergone the kind of standardization seen, for example, in forensic dna analysis”). 189 see hon. jed s. rakoff, guilty vs. guiltiness responses: science and the law: uncomfortable bedfellows, 38 seton hall l. rev. 1379, 1392 (2008). 190 generalized neuroscience evidence—or group data—is the kind of information that captured the attention of the u.s. supreme court in juvenile sentencing cases. see, e.g. alabama v. miller, 132 s. ct. 2455, 2464-65 (2012). 191 professor farah has suggested that where an observable organic phenomenon exists in a person’s brain, we are more likely to associate that phenomenon with behavior. see farah, supra note 168, at 38. she pointed to the well-known case of phineas gage, the railway worker who suffered traumatic brain injury and experienced a personality change. professor farah stated that “we are not inclined to blame phineas gage for his bad behavior” because of the apparent organic basis. id. she noted that neuroscience is uncovering “the more subtle and gradual ways” that organic changes in the brain may influence behavior. id. these will present the law with more difficult challenges. 642 indiana health law review vol. 12:2 conducted on the party herself. even when such individualized studies indicate a clinical brain condition, the relationship between the condition and the behavior in question in the case will still require complex expert extrapolation. moreover, tort cases typically focus intently on subjective and historical issues—what the parties understood at a particular moment in the past. because many of the studies using functional neuroimaging report the results by group averages, at best these studies provide generalized information about the group. at least at the current stage of neuroscience technology and research, this evidence would result in too large an analytical gap for the evidence to be admissible without additional specific evidence. still, these averaged group studies could be a useful starting point for specific individuals or may provide more acceptable information in combination with a variety of other more individualized psychiatric or neurological evidence. how the experts interpret the information and apply it to the issues of a particular tort case must then pass legal muster under the rules of evidence for reliability and relevance. to date, proponents of neuroimaging studies have had difficulty meeting evidentiary standards.192 difficult evidentiary issues should not, by themselves, prohibit neuroscience from being used in the courtroom. courts have no rational basis for rejecting evidence of mental disabilities simply because the issues are complex or because the fact questions present administrative difficulties. on the other hand, courts must subject neuroscience evidence to the same systematic scrutiny that applies to other expert evidence and should resist being lured by the excitement of what it promises. the next part 192 see, e.g., united states v. semrau, no. 07-10074 mi/p, 2010 wl 6845092 (w.d. tenn. june 1, 2010). in semrau, the magistrate judge discussed at length fmri evidence, proffered on the issue of veracity, in relation to the daubert test, concluding that “[a]lthough [the expert] is qualified to offer an opinion, the court nevertheless concludes that his testimony should be excluded because, at least at this early stage in its development, fmri based lie detection does not satisfy the requirements of rule 702.” id. at *10. 2015 will neuroscience reform tort doctrine? 643 proposes a cautionary way to begin the discourse about envisioning a constructive role for neuroscience in the longoverdue reformation of the bifurcated rule. v. a modest proposal with caveats in an earlier article, eric j. laury and i proposed a broad process-based model for involving neuroscience in tort law.193 our proposal served as a kind of prolegomena to a fuller process of integrating information obtained from neuroscience, and neuroimaging in particular, into tort doctrine. it was based on the notion that a better understanding of the brain can help us to determine the validity of the premises on which tort doctrine is based. the proposal was “sufficiently broad and flexible to accommodate both the rapidly evolving science and tort law’s resistance to change.”194 as the technologies grow in reliability and inform the issues frequently raised in tort cases, neuroscience may add a valuable dimension to tort issues and help to shape tort doctrine in the future. this article begins the process of applying that model. for the model to be effectively implemented, neuroscience must be introduced in tort cases incrementally on an issue-by-issue basis. this task presupposes identifying a doctrinal issue that needs correcting, supplementing, or reforming. the bifurcated negligence rule of physical and mental disabilities is just such an issue. accordingly, this rule may provide an effective doctrinal “laboratory” for using the neuroscience to reform an aspect of tort law that is outmoded. this issue is a logical and appropriate place to begin the analysis for several reasons. first, the essence of the bifurcated rule is disparate treatment of adults with mental disabilities, which directly implicates neuroscience. indeed, some techniques and theories related to the organic basis of mental conditions and symptomatology already have wide acceptance in the neuroscience and psychiatric communities and are regularly 193 see eggen & laury, supra note 9, at 284-86. 194 id. at 284. 644 indiana health law review vol. 12:2 used in the courts. second, most of the policies asserted to justify the bifurcated rule no longer hold up in an era in which more detailed information is known about mental diagnoses and about brain structure and function.195 third, the bifurcated rule has perennially been the subject of much criticism over the years, even before neuroscience began to make inroads into the law,196 and neuroscience can serve as the tipping point to finally abrogate the objective rule for mentally disabled adults. a. a framework for commencing the discourse with these matters in mind, this article proposes the following modest framework for employing neuroscience to reform the bifurcated rule in tort doctrine. 1. the duty rule for adults with mental disabilities should be consistent with the rule for physical disabilities. the bifurcated rule should be replaced with a single subjective duty rule for adults with disabilities, whether physical or mental. a single rule would not only establish a single duty standard for adults with disabilities in negligence actions. it would also bring negligence law into agreement with intentional torts on matters related to mental disabilities and would be consistent with the negligence standard for children. 2. the unified subjective rule should expressly recognize that many mental disabilities are organic in nature. the third restatement explicitly recognized that “many mental disabilities have organic causes,” but opted to retain the traditional bifurcated rule for policy reasons, including administrative convenience.197 those mental disabilities without currently known organic causes will not necessarily 195 see supra notes 146-58 and accompanying text. 196 see articles cited supra note 8. 197 restatement (third) of torts: liab. for physical and emotional harm § 11 cmt. e (2010). 2015 will neuroscience reform tort doctrine? 645 be excluded from consideration in a negligence case under the unified subjective rule, though it may be more difficult for the party to establish the existence of the disability. recognizing the organic basis of mental disabilities, courts would no longer be required to place certain mental conditions on one side or the other of an artificial line between physical and mental. for example, old age dementia, whether resulting from a vascular condition, alzheimer’s, or an unknown operation of the aging process on the brain would be considered a disability and treated the same. 3. to be considered in determining liability, the mental disability must be “significant and objectively verifiable.”198 this limitation would eliminate minor variations in temperament from being considered, and would require proof of the disability. structural and functional neuroimaging, if available, would be allowable, provided that the proof is independently admissible under the rules of evidence. the requirement that the disability be “significant and objectively verifiable” is already the standard for physical disabilities.199 this proposal does not limit the rule to “organic disabilities” because of concern that such a rule would be underinclusive. some “significant and objectively verifiable” mental disabilities may not be detectable as organic changes in the brain or other bodily organs. thus, this proposal would not require neuroscience evidence as a prerequisite; rather, other types of psychiatric evidence and other clinical medical evidence may be sufficient in some cases. 4. all expert evidence of mental disabilities, including all neuroscience evidence, will be subject to the applicable rules of evidence. 198 id. § 11 cmt. a (2010) (discussing physical disabilities only). 199 id. 646 indiana health law review vol. 12:2 neuroscience evidence should be treated the same as any other scientific, technological, or other expert evidence. it should not be held to a higher standard for admissibility, nor should it be held to a lesser standard because of its novelty. accordingly, any neuroscience evidence and other evidence offered to prove the mental disability and its causal relevance to the tort would be required to meet the applicable evidentiary standards in the jurisdiction, whether that standard conforms to daubert, frye, or a hybrid rule. 5. there should be no new defense for persons with mental disabilities. in this article, the concepts of intent in intentional torts and duty/breach in negligence law have been singled out as specific elements that could benefit from emerging information obtained from neuroscience. this article does not suggest that a legal defense should be created that would relieve a mentally disabled defendant of liability for his or her conduct in the same sense as the insanity defense operates in criminal law. no new defense should be created where one did not exist for persons with physical disabilities.200 6. existing privileges and defenses that involve mental conditions should remain in effect. thus, in an intentional tort action in which the defendant asserts the privilege of consent, a plaintiff asserting that he or she did not consent because of lack of capacity due to a mental disability would still be required to demonstrate both the existence of the incapacity and that the defendant knew of the incapacity. in jurisdictions such as wisconsin, where sudden mental incapacitation is recognized as a defense to a negligence claim according to 200 the third restatement states: “under this section, physical disability is neither a ‘justification’ nor an ‘excuse’ for what is otherwise negligent conduct.” id. at cmt. b. 2015 will neuroscience reform tort doctrine? 647 the same rules as sudden physical incapacitation201—i.e. proof of the incapacitation along with lack of foreseeability—no change in the applicable rules would occur for this narrow set of circumstances. b. some caveats this article has emphasized the need for caution in moving toward a beneficial amalgamation of neuroscience and tort law. neuroscience is not a talisman that provides an immediate answer to all human behavioral questions. and it will never, by itself, provide definitive answers to the normative questions inherent in tort law. the proposal in this article demonstrates that neuroscience has much to contribute to tort law, however, both in resolving individual cases and reforming an anachronistic tort doctrine to reflect contemporary knowledge and values. two broad caveats accompany this cautionary approach. 1. courts should be cognizant of the limitations of the technology. this article has mentioned only a few of the technical limitations of neuroimaging that may impact tort law, and others exist.202 in general, and for the foreseeable future, neuroimaging is interpretive.203 it will continue to progress and improve in sophistication, accuracy, and interpretive consistency, and as it does so it will become more useful in tort cases. hardware, software, statistical programs, and the human factor—involving both the researchers and the subjects—will continue to create challenges to 201 breunig v. am. family ins. co., 173 n.w.2d 619, 622 (wis. 1970). 202 see supra notes 124-36 and accompanying text. for a brief summary of many of these technical limitations from the perspective of a lawyer, see morse, supra note 124, at 343-45. 203 see brown & murphy, supra note 128, at 1162-63 (stating that “we are at present a considerable distance away from the precise mapping of complex mental state onto unique brain activation patterns”). 648 indiana health law review vol. 12:2 understanding and using the data that are compiled. determining what is “normal” or “abnormal” is a complex matter of interpretation of the data.204 translating those data into a legal standard, such as “reasonableness” or “intent,” is even more difficult. 2. courts should take care to apply the same evidentiary scrutiny to neuroscientific evidence as to other expert evidence, no more and no less. as neuroscience moves into the courtroom, the transition will not be smooth. for scientists, observations and conclusions depend solely on the validity of the methodology.205 in contrast, the law asks experts to extrapolate from their observations to answer normative questions generated by the law applicable to the particular case. instead of viewing this as a disconnect that is unresolvable, lawmakers and neuroscientists should come together for a closer understanding of what is scientifically known and unknown and the ways that science can inform the law.206 that process has already begun. should the law 204 see grafton, supra note 6, at 57. 205 see david l. faigman et al., 1 modern scientific evidence: the law and science of expert testimony § 4:2, at 137 (2005–2006). the scientists’ view may be stated as follows: to real scientists a finding of fact is only as good as the methods used to find it. scientific method is the logic by which the observations are made. well designed methods permit observations that lead to valid, useful, informative answers to the questions that had been framed by the researcher. for scientists, the key word in the phrase “scientific method” is method. methodology—the logic of research design, measures, and procedures—is the engine that generates knowledge that is scientific. id. lawyers, by contrast, ask a different set of questions. the fit between the product of scientific inquiry and the product of legal inquiry, particularly in the courtroom, is not a close or natural one. rather, it is forced and artificial. yet the system must find a way to accommodate both approaches. 206 commentators have been quick to remind us that it was not all that long ago that phrenology—the study of the anatomical terrain of the human skull—was believed to provide answers to the sources of 2015 will neuroscience reform tort doctrine? 649 remain stagnant while science progresses? this epistemological question is intrinsic to any effort to use science to shape the law. as the courts attempt to resolve this tension, many evidentiary challenges will arise. courts should be vigilant in applying admissibility standards, recognizing that there is no precise method for translating scientific knowledge into legal certainty or factual truth in the courtroom. vi. conclusion neuroscience has the potential to be a tsunami wave that will soon bear down upon the courts with copious amounts of data and no dearth of opinions about what the data mean. should tort law run from it or face it head-on? neuroscience will only become more prevalent and more sophisticated, not less so. the law should be prepared to address the relentless advance of new techniques, theories, and philosophical questions that neuroscience brings with it. although neuroscience may be considered an emerging field, tort law has much to gain from what neuroscience has to offer. this is most true when considering the ways in which tort doctrine treats alleged adult tortfeasors who are mentally disabled. in negligence law, the traditional bifurcated rule of duty—which refuses to consider the mental disabilities of adults in negligence actions but considers physical disabilities—has remained virtually unchanged for centuries and is based upon outmoded assumptions and negative stereotypes. this rule is a logical place to begin a reasoned discourse about how new developments in neuroscience can play a role in reforming human behavior. see stacey a. tovino, imaging body structure and mapping brain function: a historical approach, 33 am. j.l. & med. 193, 195-207 (2007). some might argue that phrenology was a direct precursor to what we consider the new neuroscience. see id. at 207 (“although phrenology ultimately failed as a science, it left behind a formalized concept of cerebral localization and the idea that science, perhaps a science not too different from the pseudoscience of phrenology, could be used to investigate the functions of different regions of the brain.” (footnote omitted)). 650 indiana health law review vol. 12:2 tort doctrine to meet the realities of the twenty-first century. i. introduction ii. the basics of mental disabilities in tort law a. intentional torts b. the law of negligence c. judicial exceptions to the bifurcated rule iii. mental disability in tort doctrine: is there a role for neuroscience? a. a very brief look at the advantages and weaknesses of functional neuroimaging b. stigma and stereotypes c. is tort law ready for neuroscience?: revisiting the policies of the bifurcated rule iv. the evidentiary challenges of applying neuroscience to tort law a. the intersection of law and science b. neuroethics and the search for truth in the courtroom c. is neuroscience ready for tort law?: moving from the laboratory to the courtroom v. a modest proposal with caveats a. a framework for commencing the discourse 1. the duty rule for adults with mental disabilities should be consistent with the rule for physical disabilities. 2. the unified subjective rule should expressly recognize that many mental disabilities are organic in nature. 3. to be considered in determining liability, the mental disability must be “significant and objectively verifiable.”198f 4. all expert evidence of mental disabilities, including all neuroscience evidence, will be subject to the applicable rules of evidence. 5. there should be no new defense for persons with mental disabilities. 6. existing privileges and defenses that involve mental conditions should remain in effect. b. some caveats 1. courts should be cognizant of the limitations of the technology. 2. courts should take care to apply the same evidentiary scrutiny to neuroscientific evidence as to other expert evidence, no more and no less. vi. conclusion yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members maggie c. little* i. introduction ................................................................ 234 a. the issues................................................................... 238 b. roadmap .................................................................... 241 ii. background ................................................................. 242 a. the fda’s proposed changes to the nutrition ....... 242 facts label ...................................................................... 242 b. added sugar disclosure ............................................ 244 c. first amendment protected speech ........................ 245 d. central hudson standard introduction .................. 247 e. r.j. reynolds tobacco co. under central hudson . 247 f. trans fatty acids under central hudson ............... 249 g. zauderer standard introduction .............................. 250 h. international dairy foods association under zauderer .......................................................................... 251 i. american meat institute under zauderer ................ 252 iii. analysis .................................................................... 255 a. commercial speech analysis ................................... 255 b. zauderer or central hudson .................................... 255 1. central hudson standard analysis .......................... 256 2. zauderer standard ....................................................... 257 * j.d. candidate, 2016, indiana university robert h. mckinney school of law; m.h.s.a., 2013, university of evansville; b.s., 2013, university of evansville. http://dx.doi.org/10.18060/3911.0016 234 indiana health law review vol. 13:1 c. zauderer first amendment analysis ...................... 258 1. purely factual ............................................................... 259 2. uncontroversial ............................................................. 259 3. legitimate government interest ............................... 261 4. disclosure must be reasonably related ................. 264 5. disclosure is not unjustified or unduly burdensome ......................................................................... 267 d. final policy reasons for implementing the proposed rule ................................................................. 269 iv. conclusion .................................................................. 270 i. introduction in recent years, consumers have become increasingly concerned about the ingredients and overall nutritional content of foods they are eating. such concerns often stem from weight-loss programs, food allergies, and environmental concerns. the nation has seen a number of movements in this direction ranging from calorie counting via mobile apps,1 and “gluten free”2 diets to the overall “clean eating”3 concept. 1 kathy niedler, self tracking fitness, review of popular myfitnesspal app, imedical apps: medpage today, (nov. 12, 2012) http://www.imedicalapps.com/2012/11/review-popular-myfitnesspal-appfitness/ [http://perma.cc/wfp7-t4tz] myfitnesspal is a mobile app that allows users to track daily intake of calories and nutrients by selecting foods from a database or by manually entering the information from the nutrition facts label. 2 mayo clinic staff, gluten-free diet, the mayo clinic http://www.mayoclinic.org/healthy-living/nutrition-and-healthy-eating/ in-depth/gluten-free-diet/art-20048530 [http://perma.cc/b7c9-qwdr] (last updated nov. 25, 2014). a gluten free diet is a diet that excludes the protein gluten and is typically followed by those with celiac disease, although the diet has more recently become popular among non-celiac disease sufferers. id. 3 lauren torrisi, what the heck is clean eating? abc news (apr. 5, 2013), http://abcnews.go.com/blogs/lifestyle/2013/04/what-the-heck-isclean-eating [http://perma.cc/n4el-jwy9]. (stating that “clean eating” is the concept that the shorter the ingredient list of a food, the better. the http://perma.cc/wfp7-t4tz http://perma.cc/n4el-jwy9 2016 235 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members the fda has stepped in with an attempt to assist consumers with understanding the nutritional content of foods in response to consumer interest to learn more about the nutrients in common foods. the fda made such an attempt by a proposal to add more detailed nutrition information to nutrition facts labels, as well as a proposal for a restructured label to make the label easier for consumers to read and understand.4 in addition to assisting the individuals who are following strict diets, the fda recognized the need to improve the accessibility of nutrition information for all consumers due to the current obesity epidemic throughout the united states.5 to address various health concerns, such as obesity and the chronic conditions associated with obesity, the fda proposed updates to the nutrition facts labels of packaged food products to provide consumers with the necessary and important information to make healthy food choices.6 among the updated information, the fda hopes to implement a requirement of the disclosure of the amount of added sugar on the nutrition facts label as part of a major overhaul to the nutrition facts label.7 as support for the added sugar disclosure, the fda asserted all the proposed changes to the nutrition facts label are necessary and impactful because recent studies have shown that the number of consumers that use the information on the nutrition facts label has grown since 2002,8 which is not surprising due to calorie counting, clean eating and gluten free trends.9 further, the fda concluded the new added idea focuses on eating whole foods that lack artificial preservatives, sugars, and other additives.). 4 proposed changes to the nutrition facts label, fda, http://www.fda.gov/food/guidanceregulation/guidancedocumentsregul atoryinformation/labelingnutrition/ucm385663.htm [http://perma.cc/ 9vpe-3aep] (last updated july 27, 2015) [hereinafter “proposed changes”]. 5 id. 6 id. 7 id. 8 id. 9 gluten-free diet appeals to 30percent of adults, survey says, huffington post (mar. 6, 2013), http://www.huffingtonpost.com/2013/ 03/06/gluten-free-diet_n_2818954.html [http://perma.cc/7v4p-gctr] http://perma.cc/7v4p-gctr 236 indiana health law review vol. 13:1 sugar disclosure requirement will encourage food manufacturers to reformulate products to include less overall added sugar.10 the necessity of such updates to the nutrition facts label was identified before the fda stepped in with the proposed rule in 2014. in 2010, the center for science in the public interest (“cspi”) released a report that called for the reform of food labeling legislation.11 cspi called for eight specific updates to the nutrition facts label in its report, largely because the label has not been updated since the passage of the nutrition labeling and education act of 1990 (“nlea”).12 further, cspi asserted the updates to the label are essential because the current label from nlea was not designed to prevent or reduce obesity.13 the fda included some form of most of the changes recommended by cpsi in the proposed rule.14 cspi recommended an update to the design of the nutrition facts label by increasing the font size of the word “calories,” as well as changing the “amount per serving” statement.15 the organization also recommended a modification to the serving size for foods that are reasonably likely to be consumed by one person in a single sitting.16 additionally, cspi recommended an update to the serving size of foods to more closely reflect the larger portion sizes consumed today.17 (reporting that “[t]hirty percent of adults are interested in avoiding or cutting down in gluten in their diets.”); announcing 75 million myfitnesspal users, hello healthy, myfitnesspal updates (dec. 9, 2014), http://blog.myfitnesspal.com/announcing-75-million-myfitnesspalusers/ [http://perma.cc/epq6-8fr9]. myfitnesspal claims to have 75 million registered users of the app worldwide as of 2014. 10 proposed changes, supra note 4. 11 bruce silverglade & ilene ringel heller, food labeling chaos: the case for reform, the ctr. for science in the pub. interest 1 (mar. 2010), http://www.cspinet.org/new/pdf/food_labeling_chaos_report.pdf. [http://perma.cc/l7n6-nb3x]. 12 id. at i-1. 13 id. 14 see generally, food labeling: revision of the nutrition and supplement facts label, 79 fed. reg. 11880 (mar. 3, 2014) (to be codified at 21 c.f.r. 101) [hereinafter “food labeling”] 15 id. at i-2. 16 id. 17 silverglade & ringel heller, supra note 11, at ii-3. http://perma.cc/epq6-8fr9 2016 237 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members cspi also proposed including the amount of added sugar to the label, as well as the creation of a recommended daily value for added sugar.18 nearly four years after cspi published the report highlighting the recommended updates to the nutrition facts label, the fda published the proposed rule, “food labeling: revision of the nutrition and supplement facts label” in the federal register on march 3, 2014.19 additionally, the fda published revisions to the 2014 proposed rule on july 17, 2015.20 first lady michelle obama also expressed her support for an updated nutrition facts label with an endorsement of the fda’s proposed rule during an event for her “let’s move!” campaign.21 during the event she emphasized the importance of labels that are easier for consumers, who have little or no nutrition knowledge to understand.22 she noted that consumer-friendly labels would help consumers make informed and healthy decisions based on the information provided in the new label.23 the first lady also specifically applauded the added sugar disclosure by stating “[y]ou’ll also learn where sugar in food comes from—if sugar in yogurt is added during processing or comes from fruits. this is a huge deal.”24 the campaign for the updated nutrition facts label also follows the passage of the front of package label requirements.25 once food manufacturers started using front 18 id. at ii-1. 19. food labeling, supra note 14. 20 food labeling: revision of the nutrition and supplement facts label: supplemental proposed rule to solicit comment on limited additional provisions, 80 fed. reg. 44303 (july 17, 2015) (to be codified at 21 c.f.r. 101) [hereinafter “supplemental proposed rule”]. 21 sabrina tavernise, new fda nutrition labels would make serving sizes reflect actual servings, n.y. times (feb. 27, 2014), http://www.nytimes.com/2014/02/27/health/new-fda-nutrition-labels would-make-serving-sizes-reflect-actual-servings.html?_r=1., [http:// perma.cc/7znw-ebbt]. 22 id. 23 id. 24 id. 25 kathryn e. hayes, front of package nutrition claims: trustworthy facts or deceptive marketing? closing the loopholes in labeling, 19 cardozo j.l. & gender 545, 550 (2013); see also background 238 indiana health law review vol. 13:1 of package labels, the government recognized a need for easier to understand nutrition facts labels because many consumers could not properly understand the nutrition facts labels and therefore relied on sometimes misleading front of package labels.26 fruit snacks often appear to be a healthy snack choice for children based on the front of package label that boasts, “made with real fruit.”27 however, after a proper examination of the ingredients label, these seemingly healthy fruit snacks are filled with corn syrup—a form of added sugar that increases the calories in the snack.28 if the consumer had been able to find the high amount of added sugar conveniently located on the nutrition facts label, the mistake of consuming a snack high in added sugar that claims to be “made with real fruit” could have been avoided.29 a. the issues despite the urgent need for updated nutrition facts labels with an added sugar disclosure, the fda faces pushback from food manufacturers. the fda was required by law to allow time for comments from the public after the 2014 proposed rule was published, and must consider and evaluate all comments before promulgating a final rule.30 information on point of purchase labeling, fda (oct. 2009) http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutriti on/ucm187320.htm [http://perma.cc/s9uj-4ecq] [hereinafter point of purchase labeling]. (front of package (“fop”) labels often include nutritional information in addition to health or nutrient content claims and the fop labels may also be in the form of graphics that indicate the food is a “healthy choice,” although evidence suggests that the graphics can give the products an “overrated” view of healthiness). 26 hayes, supra note 25, at 550. 27 id. at 564. 28 id. at 565. 29 id. 30 administrative procedures act, 5 u.s.c §553 (2015) (“…the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments”). food labeling, supra note 14 at 11880 (initially, the comment period was open for 90 days after the proposed rule was published on march 3, 2014). food labeling: revision of the nutrition and supplement facts labels; extension of comment period, 79 fed. reg. 30055 (may 27, 2014). (the fda extended the comment period to august 1, 2014 in response to many 2016 239 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members further, the 2015 supplemental proposed rule reopened the comment period in order to solicit additional comments for a limited number of provisions that were revised based on new evidence and some of the public comments.31 in many of the public comments that opposed the 2014 proposed rule, there was an assertion that the mandatory disclosure of added sugar infringes on first amendment rights to free speech, specifically the right to “refrain from speaking.”32 ocean spray cranberries, inc. asserted in their comment that the added sugar disclosure will fail first amendment scrutiny.33 in addition to alleging first amendment violations, food industry members also claimed the disclosure is unwarranted and misleading.34 based on such comments, it seems fair to assume challenges may be brought against the disclosure because some food industry members consider it controversial.35 the food industry had similar comments and concerns when the mandatory disclosure of trans fats was introduced in 2003.36 the requests for the extension because the 90-day period was not sufficient time to develop thoughtful comments and suggestions). 31 supplemental proposed rule supra note 20, at 44311. 32 glenn g. lammi, fda’s “added sugar” labeling proposal: more information isn’t always better (or legal), forbes (sept. 8, 2014), http://www.forbes.com/sites/wlf/2014/09/08/fdas-added-sugar-labelingproposal-more-information-isnt-always-better-or-legal/ [http://perma.cc/ u3kt-zauj]. 33 public comment from ocean spray cranberries, inc. on proposed rule: food labeling: revision of the nutrition and supplement facts labels (aug. 1, 2014), available at http://www.regulations.gov/ #!documentdetail;d=fda-2012-n-1210-0388 [http://perma.cc/7s772yk7]. 34 public comment from decas cranberry products on proposed rule: food labeling: revision of the nutrition and supplement facts labels (aug. 1, 2014), available at http://www.regulations.gov/ #!documentdetail;d=fda-2012-n-1210-0085 [http://perma.cc/7zpa36mp] (“…the inclusion of ‘added sugar’ as a separate item within the nutrition facts panel, is scientifically unwarranted, and will create confusion with consumers as to the healthful properties of cranberry products.”). 35 tavernise, supra note 21. 36 food labeling: trans fatty acids in nutrition labeling, nutrient content claims, and health claims, 68 fed. reg. 41434, 41439 (july 11, 2003) [hereinafter “trans fatty acids”]. (“several general comments 240 indiana health law review vol. 13:1 previous comments on the trans fat disclosure support the likelihood of formal first amendment challenges to the added sugar disclosure. the first issue with respect to the added sugar disclosure that must be resolved is whether it would survive such first amendment challenges. the resolution of such a challenge requires that a court first determine whether the labeling disclosure is commercial speech37. once the disclosure is regarded as commercial speech, the court must determine the appropriate standard to apply in analyzing the disclosure.38 similar commercial speech challenges, such as warning labels on tobacco products, were held under the standard created in central hudson gas & electric corp. v. public service commissioner. however, recent litigation regarding meat product labeling was held to the more lenient standard created in zauderer v. office of disciplinary counsel of supreme court. in the 2014 d.c. circuit case, american meat institute v. usda, the challenged country-of-origin disclosure on meat products was held to the reasonable relationship zauderer standard, discussed in further detail later in this note.39 the decision was declared to be a “win for public health” because it opened the possibility of holding future food labeling challenges to the same standard.40 were received asserting that the agency’s action to mandate labeling is subject to review under the first amendment”). 37 see lucien j. dhooge, the first amendment and disclosure regulations: compelled speech or corporate opportunism?, 51 am. bus. l.j. 599 (2014). 38 courts have historically analyzed commercial speech first amendment challenges under the standard created in central hudson or zauderer, discussed in further detail later in this note. 39 jonathan h. adler, en banc d.c. circuit upholds usda countryof-origin labeling rule, volokh conspiracy (july 30, 2014), http://www.washingtonpost.com/news/volokh-conspiracy/wp/2014/07/30/ en-banc-d-c-circuit-upholds-usda-country-of-origin-labeling-rule/ [http:// perma.cc/8man-mmvd]. 40 kerry cork, court decision on “mandatory disclosure” could be a big win for public health, network for public health law blog (aug. 6, 2014, 11:40 am), https://www.networkforphl.org/ the_network_blog/2014/08/06/480/court_decision_on_mandatory_disclos ure_could_be_a_big_win_for_public_health, [http://perma.cc/w2uv7h5g]. http://dx.doi.org/10.1111/ablj.12034 2016 241 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members even though some food industry members asserted the added sugar disclosure should be held to the central hudson standard,41 a court would likely hold the fda’s proposed added sugar disclosure to the zauderer standard because of the american meat institute analysis. through the application of the reasonable relationship test from zauderer, a court would likely find the added sugar disclosure to survive first amendment challenges due to the many legitimate government interests for providing information about the amount of added sugar in a product for consumers. b. roadmap this note will begin by exploring the fda’s proposed rule, “food labeling: revision of the nutrition and supplement facts labels,”42 with an emphasis on the added sugar disclosure. next, the note will transition into an examination of first amendment standards in the context of commercial speech and an evaluation of the standards that courts have used when examining such disclosures. as a continuation of the first amendment evaluation, the note will also discuss some of the most recent food labeling litigation and provide an analysis of the court’s review under the respective standard applied by the court. after evaluating recent case law regarding food labeling, a determination of whether the central hudson or zauderer standard should apply to the disclosure will be made. finally, the note will analyze the added sugar disclosure requirement under the five-prong reasonable relationship test from zauderer and explain the reasons why the disclosure will withstand first amendment challenges under this standard. the final section will also provide a few supporting policy reasons for the proposed rule and explain 41 public comment from the corn refiner’s association on proposed rule: food labeling: revision of the nutrition and supplement facts labels (aug. 1, 2014),) available at http://www.regulations.gov/ #!documentdetail;d=fda-2012-n-1210-0455 [http://perma.cc/rz4grbyb] (asserting the added sugar disclosure would fail first amendment scrutiny under the four prong test from central hudson). 42 food labeling, supra note 14, at 11880. 242 indiana health law review vol. 13:1 why the fda should move forward with a final rule, regardless of potential first amendment challenges. ii. background the fda published an initial proposed rule, “food labeling: revision of the nutrition and supplement facts label” in the federal register on march 3, 2014 and published revisions to the initial proposed rule on july 17, 2015.43 the fda’s main goal of the proposed rule was to update the regulations to better assist consumers in maintaining healthy eating practices by improving “how the information is presented to consumers.”44 the fda aimed to achieve such a goal with three major categories of proposed changes to the nutrition facts label. a. the fda’s proposed changes to the nutrition facts label the first major category of changes is designed to create a “greater understanding of nutrition science45 by adding the amount of added sugar to the label, an update to the “percentage of daily value” for some nutrients, and removal of the line “calories from fat.”46 by modifying the label, the fda hopes to provide consumers with the necessary information to understand the link between the nutrients and calories consumed and obesity.47 in addition, the update to the percentage of daily values for some nutrients, such as sodium, dietary fiber, and vitamin d, will help consumers understand the role the nutrients play in their overall daily diet.48 43 id.; supplemental proposed rule, supra note 20, at 44303. 44 food labeling, supra note 14, at 11880. 45 proposed changes, supra note 4. 46 see id.; nutrition facts label: proposed changes aim to better inform food choices fda (feb. 2014), http://www.fda.gov/downloads/ forconsumers/consumerupdates/ucm395422.pdf [http://perma.cc/ tk6p-elrn].2x3x-pak5]. (the fda has proposed the removal of “calories from fat” because evidence shows the type of fat is more important than the total amount of fat). 47 proposed changes, supra note 4. 48 id. 2016 243 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members the second major category of changes to the nutrition facts label is intended to update the “serving size requirements.”49 one update calls for “new labeling requirements for certain package sizes,”50 including modifying serving sizes for food and drinks typically consumed in one sitting.51 currently, a twenty-ounce bottle of soda is labeled as more than one serving.52 with the proposed changes to the nutrition facts label, the soda would be labeled as one single serving because it is most often consumed in one sitting, by one consumer.53 additionally, the serving sizes of certain foods and drinks will be updated to reflect the larger portions americans consume today.54 for example, a pint of ice cream is currently labeled as four servings—about half a cup per serving.55 the fda proposed a change to the number of servings in a pint of ice cream to two servings in order to more accurately represent the larger portions consumed by americans.56 finally, the last category of proposed changes to the nutrition facts label is intended to create a “refreshed design”57 with more emphasis on the serving size and calorie content of the label.58 serving size and calorie content are essential pieces of information for consumers to understand in order to make healthy choices to prevent obesity and other chronic conditions.59 the new label would also relocate the percentage of daily value, another important piece of information used to make healthy choices, to the left of the nutrients so that it will also quickly attract consumer attention.60 49 id. 50 id. 51 id. 52 id. 53 id. 54 id. 55 id. 56 id. 57 id. at 4. 58 id. 59 id. 60 id. 244 indiana health law review vol. 13:1 b. added sugar disclosure based on a review of the public comments to the 2014 proposed rule, it appears the added sugar disclosure sparked the most conversation and will therefore be reviewed with the most detail in this note. the fda proposed the amount of added sugar in a food should be included in the nutrition facts label, indented under the line where “sugar” is currently listed.61 the fda proposed the disclosure based on the updated recommendation to reduce the number of calories consumed from excess solid fat and added sugars,62 as well as a recommendation of the amount of energy intake that should come from added sugars.63 currently, the institute of medicine (“iom”) dietary reference intake report recommends a maximum of twenty-five percent of energy intake from added sugars,64 based on evidence that a high intake of added sugars decreases the intake of other more important nutrient dense foods.65 along with the updated dietary recommendations, the fda also cited consumer awareness as a major support for the added sugar disclosure.66 the fda asserted that without the declaration of added sugars, consumers are unable to compare the amount of non-naturally occurring sugar in foods, such as fruit juices and yogurt.67 forms of added sugar are often listed in the ingredients section of food labels under complex chemical names that many consumers do not understand or recognize as a form of sugar.68 finally, the fda provided four additional reasons to include the disclosure of added sugars on the nutrition facts label to improve consumer awareness, including: 61 id. 62 food labeling, supra note 14, at 11903. (“…to meet nutrient needs within an individual’s calorie limits, a key recommendation of the 2010 dga is to reduce the intake of calories from solid fats and added sugars”). 63 id. at 11902. 64 id. 65 id. 66 id. at 11904. 67 id. 68 i d. 2016 245 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members (1) the variability in ingredients used, (2) the need for consumers to have a consistent basis on which to compare products, (3) the need for consumers to identify the presence or absence of added sugars, and (4) when added sugars are present, the need for consumers to identify the amount of added sugars added to the food.69 additionally, one of the revisions contained in the 2015 supplemental rule would also require a daily recommended value (“drv”) for added sugars to be displayed on the nutrition facts label.70 the fda initially rejected this idea in the 2014 proposed rule based on a lack of evidence for the establishment of a drv.71 however, the 2015 dietary guidelines advisory committee performed additional updated research and suggested the label should include a declaration of a percent of daily value for added sugars.72 c. first amendment protected speech after establishing a foundation for why the fda believes the added sugar disclosure on the nutrition facts label is necessary, it is essential to establish the foundation of the challenges that may be brought against the disclosure. a discussion of the types of first amendment protected speech and how they are distinguished is necessary to understand why the food industry opposes the disclosure. a first amendment challenge brought by the food industry to protect its right to not speak or right to not disclose information would fall under the context of commercial speech. the supreme court classifies commercial speech as “speech which does no more than propose a commercial transaction,”73 and later extended the definition to include speech “related solely to the economic 69 id. 70 supplemental proposed rule, supra note 20, at 44308. 71 food labeling, supra note 14, at 11902. 72 supplemental proposed rule, supra note 20, at 44307. 73 dhooge, supra note 37, at 606-07 (quoting pittsburgh press co. v. pittsburg comm’n on human relations, 413 u.s. 376, 386 (1973)). 246 indiana health law review vol. 13:1 interests of the speaker and its audience.”74 the court also included speech in which the transaction was “the core notion of commercial speech.”75 commercial speech is afforded a different type of protection than individual speech and can be restricted in ways that individual speech cannot be restricted.76 such restriction may be in the form of a disclosure of additional information, warnings and any disclaimers that would be helpful in preventing deception in consumers.77 the idea of different restrictions for commercial speech is based on the theory that the government has an interest in ensuring “the flow of truthful and legitimate commercial information is unimpaired.”78 commercial speech can also be considered compelled speech, subject to government restrictions and requirements.79 in a corporate or commercial context, compelled speech can be generally categorized as speech the government requires of the corporation.80 two standards developed by the supreme court are typically used for evaluating whether commercial speech is protected under the first amendment. in recent years, courts appear to be split in deciding the standard to apply to the different types of commercial speech, which has led to controversy over the issue. both standards, the stricter from the 1980 case, central hudson gas & electric corporation v. public service commissioner, and the more lenient from the 1985 case, zauderer v. office of the disciplinary counsel of supreme court, may be applied to speech restrictions or compelled speech. 74 id. at 607 (quoting cent. hudson gas & elec. corp. v. pub. serv. comm’n, 447 u.s. 557, 561 (1980)). 75 id. (quoting bolger v. youngs drug prods. corp., 463 u.s. 60, 66 (1983)). 76 id. at 606. 77 id. 78 id. (quoting va. state bd. of pharmacy v. va. citizens consumer council, inc., 425 u.s. 748, 771 n.24 (1976)). 79 id. at 611. 80 id. at 609–611. 2016 247 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members d. central hudson standard introduction the standard from central hudson has been used for commercial speech cases related to compelled speech in the form of labeling, however there is concern as to whether it is the appropriate standard to apply in such a situation.81 the standard was most recently and notably applied to the compelled speech of graphic warning labels on cigarette packaging in r.j. reynolds tobacco company v. fda, discussed further in this section.82 additionally, the fda also included a brief first amendment analysis of the mandatory trans fat disclosure on the nutrition facts label under the central hudson standard when it published the final rule in 2003.83 in the central hudson decision, the supreme court developed a four-part intermediate scrutiny test used to analyze commercial speech.84 the four-part test begins with a determination of whether the speech concerns “lawful activity” that “must not be misleading.”85 next, the government interest in restricting the speech must be substantial.86 third, the means used to restrict or compel the speech must directly advance the substantial government interest, and finally, the means must not be “more extensive than necessary to serve that interest.”87 e. r.j. reynolds tobacco co. under central hudson the proposed graphic warning labels for tobacco products in r.j. reynolds tobacco failed the first amendment intermediate scrutiny test under the central hudson 81 id. at 618–619. 82 r.j. reynolds tobacco co. v. fda, 696 f.3d. 1205, 1209 (d.c. cir. 2012) (the graphic warnings contained a graphic photo depicting the negative effects of tobacco use, as well as the phone number for the “national cancer institute’s network of tobacco cessation quitlines”). 83 trans fatty acids, supra note 36, at 41439. 84 dhooge, supra note 37, at 616. 85 cent. hudson gas & elec. corp. v. pub. serv. comm’n, 447 u.s. 557, 566 (1980). 86 id. 87 id. 248 indiana health law review vol. 13:1 standard.88 in 2012, the family smoking and tobacco prevention act directed new regulations to be issued by the fda that required new textual, as well as graphic warnings on all tobacco product packaging.89 the graphic warning labels contained “color graphics depicting the negative health consequences of smoking.”90 the fda’s primary goal in implementing such graphic warnings was “to effectively convey the negative health consequences of smoking on cigarette packages and in advertisements.”91 once the fda implemented a final rule, “big tobacco” filed suit, alleging first amendment violations.92 before addressing the specific first amendment challenges, the court determined that the central hudson standard was the appropriate level of scrutiny to apply to the graphic warnings.93 the court’s determination rested on the finding that the warnings were not purely factual and uncontroversial, nor were the warnings intended to correct false or misleading claims made by the tobacco companies.94 the court evaluated the warnings under the central hudson standard and found the fda was able to show the purported interest of the graphic labels in reducing smoking rates was substantial.95 however, the analysis ended at the next prong because the fda was unable to produce a “shred of evidence” that the graphic warnings would directly advance the substantial interest.96 upon failing to provide substantial evidence that the graphic warnings would directly advance the substantial interest as required by the administrative procedure act, the fda’s graphic warnings failed intermediate scrutiny under central hudson.97 in the dissenting opinion of the decision, circuit judge rodgers argued the warnings should have been held to the lesser standard from zauderer because the court failed to 88 dhooge, supra note 37, at 620. 89 r.j. reynolds, 696 f.3d. at 1208 (d.c. cir. 2012). 90 id. 91 id. at 1210. 92 id. at 1211. 93 id. at 1216. 94 id. 95 id. at 1218. 96 id. at 1219. 97 dhooge, supra note 37, at 621. 2016 249 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members consider the tobacco companies’ history of deceptive marketing.98 judge rodgers also asserted the warnings should have been held to the zauderer standard because they contained “factually accurate information and addressed misleading speech.”99 f. trans fatty acids under central hudson although there was no litigation regarding the mandatory disclosure of trans fatty acids on the nutrition facts label, the fda still engaged in a brief first amendment analysis under the intermediate scrutiny standard from central hudson in the final rule, published on july 11, 2003. the fda issued a proposed rule on november 17, 1999 that called for the amount of trans fats to be disclosed on the nutrition facts label.100 the fda based the proposal for the trans fats disclosure on the label on recent evidence that showed the “consumption of diets containing trans fatty acids…resulted in increased serum low-density lipoprotein cholesterol, [ldl-c] a major risk factor for [coronary heart disease].”101 in response to the many comments claiming the mandatory disclosure of trans fat on the nutrition facts label violated the first amendment, the fda included a brief analysis of how the disclosure would pass a first amendment challenge under the central hudson standard in the final rule. the disclosure was related to lawful activity and not misleading and therefore passed the first prong of the standard.102 according to the fda, the disclosure also satisfied the second prong because the fda’s interest in requiring the amount of trans fat on the label was clearly substantial.103 98 r.j. reynolds tobacco, 696 f.3d. at 1222 (rodgers, j., dissenting). 99 id. 100 trans fatty acids, supra note 36, at 41435. 101 id. 102 id. at 41439. 103 id. (“[the] fda’s interest is substantial for at least two reasons….substantial interest in protecting and promoting public health and in preventing consumer deception by ensuring accuracy and completeness of trans fat information in labeling.”). 250 indiana health law review vol. 13:1 the fda asserted the mandatory disclosure would pass the third prong as well because it directly advanced the government interest when consumers relied on the information in the nutrition facts label in order to maintain healthy dietary practices.104 finally, the trans fat disclosure passed the fourth prong of central hudson because it was not more extensive than necessary to serve the fda’s interest.105 the fda asserted the disclosure was not extensive because it contained “truthful, factual, noncontroversial information about the presence or absence and amount of trans fat in food” that would assist consumers with choosing foods that will lower their risk of coronary heart disease.106 the fda claimed that the trans fat disclosure would pass intermediate scrutiny under central hudson, but also stated that it was likely not even necessary for the disclosure to satisfy the test.107 the fda claimed the trans fat disclosure should not have to pass the central hudson standard because it is compelled commercial speech rather than a prohibition on speech in which central hudson typically applies.108 the fda’s assertion that the mandatory disclosure should not be held to the strict standard of central hudson may provide insight into which standard will apply to the fda’s proposed added sugar disclosure. g. zauderer standard introduction in addition to the central hudson standard, courts have also used the more lenient standard from zauderer to analyze commercial speech cases. zauderer was decided after central hudson and provides an easier path for the government to pass when requiring a disclosure of additional information.109 the supreme court developed a reasonable relationship test in zauderer based on the theory that “rights are adequately protected as long as [the] disclosure requirements are reasonably related to the state’s interest in 104 id. at 41440. 105 id. 106 id. 107 id. 108 id. 109 see dhooge, supra note 37, at 621. 2016 251 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members preventing deception of consumers.”110 the reasonable relationship test consists of five prongs used to determine whether government compelled speech violates first amendment protection for commercial speech.111 the first two prongs of the reasonable relationship test require the compelled speech to be “purely factual” and “uncontroversial.”112 speech that contains “accurate factual information” has been found to satisfy the first two prongs.113 the third prong mandates a "legitimate government interest" for requiring the speech or disclosure.114 the fourth prong requires the compelled speech or disclosure to also be “reasonably related” to the legitimate interests, and finally, the compelled speech or disclosure must not be “unjustified or unduly burdensome” in order to satisfy the fifth prong.115 h. international dairy foods association under zauderer international dairy foods v. boggs is a 2010 sixth circuit case involving composition claims and label disclosures on dairy products. the ohio department of agriculture developed regulations to address the claims of “rbst free” used on dairy products that contained milk from cows not treated with rbst. 116 the department required a disclosure that addressed the fda’s findings of no significant difference between milk from cows treated with rbst and milk from cows not treated with the hormone.117 while the court 110 zauderer v. office of disciplinary counsel, 471 u.s. 626, 651 (1985). 111 dhooge, supra note 37, at 624. 112 id. 113 id. 114 id. 115 id. 116 int’l dairy foods ass’n v. boggs, 622 f.3d. 628, 640 (6th cir. 2010) (rbst is a genetically engineered hormone sometimes given to cows to increase milk production. dairy producers were using the phrase “rbst free” on labels and the fda required them to disclose that there has been no evidence that shows a compositional difference between milk from treated and untreated cows). 117 id. at 632. (the department recommended a disclosure that stated, “the fda has determined that no significant difference has been 252 indiana health law review vol. 13:1 evaluated the compensation claim under the central hudson standard, it evaluated the disclosure claim under the zauderer standard.118 the court determined the disclosure was reasonably related to the agency’s interest in preventing consumer deception because some commentators pointed out that consumers were confused about what substances are or are not in the dairy products they purchased.119 although the court concluded the actual disclosure was reasonably related to the interest, it found that the required placement and format of the disclosure lacked rational basis.120 the court also addressed whether the disclosure was unduly burdensome. in addressing the last prong of zauderer, the court found the disclosure was not unduly burdensome because it would be identical to disclosures used by other states once the ban on the use of asterisks in the disclosure was lifted.121 although the disclosure from international dairy foods does not explicitly pass the zauderer standard, it serves as an excellent example of how courts apply this standard to government compelled speech. i. american meat institute under zauderer american meat institute v. usda is the most recent food labeling case that could serve as a guide for any future litigation related to the fda’s required disclosure of added sugar on the nutrition facts label. american meat institute involved a first amendment challenge by members of the american meat institute (“ami”) against the usda for the implementation of a rule that required the country-of-origin shown between milk derived from rbst-supplemented and non-rbstsupplemented cows.”). 118 id. at 641. (“there are material differences between purely factual and uncontroversial disclosure requirements and outright prohibitions on speech”). 119 id. at 642. 120 id. at 643. (the disclosure was required to be in the exact font, case, style, color and at least half the size as the production claim and not linked to an asterisk after the claim). 121 id. 2016 253 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members of certain meat products to be disclosed on the label.122 the district court applied the zauderer reasonable relationship test to the country-of-origin disclosure and the d.c. circuit affirmed the use of zauderer for the disclosure.123 in an attempt to reject the standard applied by the district court, plaintiffs asserted that zauderer could not apply outside of government interests to prevent consumer deception.124 the plaintiffs instead asserted the stricter standard of central hudson should have applied to the mandatory disclosure.125 the d.c. circuit rejected the plaintiffs’ contention and instead held “[t]o the extent that other cases in this circuit may be read as holding to the contrary and limiting zauderer to cases in which the government points to an interest in correcting deception, we now overrule them.”126 when applying the reasonable relationship test from zauderer, the court first evaluated whether the government had a substantial interest in requiring the country-of-origin disclosure.127 throughout the evaluation, the court found several substantial government interests, even though zauderer only requires legitimate interests based on consumer choice, consumer interest, and consumer health concerns; therefore, the disclosure was reasonably related to such legitimate interests.128 the court then added that the country-of-origin disclosure was purely factual and uncontroversial.129 absent any allegations by ami that the disclosure would be unduly burdensome, the court held the disclosure was not unduly 122 am. meat inst. v. united states dep’t of agric., 760 f.3d. 18, 20 (d.c. cir. 2014). 123 id. 124 id. 125 id. 126 id. 127 id. at 23. 128 id. 129 id. at 27. (ami did not contest that the disclosure was not purely factual, but did assert it was controversial. the court rejected ami’s controversial assertion because it is not of the category of facts that are so one-sided or incomplete that they could not be uncontroversial). 254 indiana health law review vol. 13:1 burdensome.130 the country of origin disclosure therefore survived first amendment challenges under zauderer. to demonstrate how american meat institute would serve as a guide for any litigation involving the added sugar disclosure, it is important to note the government interests for requiring the country-of-origin disclosure are similar to the government interests for requiring the added sugar disclosure. the two interests will be compared later in the note, but a brief introduction to the government interests of country of origin labeling appropriately follows. as noted above, the government interests in requiring country of origin labeling were based on consumer choice, interest and health concerns. first, the more detailed label with the disclosure gives consumers the power to choose american made products.131 the government has an interest in providing consumers with the necessary information to be aware of where the food came from, especially when this expectation has been long required of other non-food products.132 finally, the government has an interest in providing consumers with the information necessary to choose meat from countries of their choice, based on individual health concerns and concerns related to food-borne illness.133 the central hudson and zauderer standards developed by the supreme court are still used by courts for compelled speech cases today as shown by r.j. reynolds tobacco, international dairy and american meat institute.134 although r.j. reynolds used the central hudson standard, american meat institute is evidence that courts are moving toward applying the more lenient zauderer standard to government compelled speech situations, possibly changing the outcome of commercial speech cases. 130 id. at 23. 131 id. at 23. 132 am. meat inst., 760 f.3d. at 23. (“…country-of-origin label mandates indeed have a long history. congress has been imposing similar mandates since 1890, giving such rules a run just short of 125 years.”). 133 id. 134 dhooge, supra note 37, at 620. 2016 255 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members iii. analysis in order to determine whether the fda’s proposed added sugar disclosure would survive a first amendment challenge brought by food industry members, it is essential to first determine how a court would analyze such a challenge. however, the analysis of whether the central hudson or zauderer standard would apply to the added sugar disclosure cannot begin without first determining whether the disclosure is considered commercial speech. a. commercial speech analysis to determine if speech is commercial speech, a court will consider three factors: “(1) whether the speech is an advertisement; (2) whether it refers to a specific product; and (3) whether the speaker has an economic motivation for speaking.”135 the three factors do not only apply to situations that involve actual speech.136 the sixth circuit found disclosures on food labels to be commercial speech in the 2010 international dairy decision.137 food labels typically present a commercial transaction for purchase and even when the label contains a disclosure, courts have considered them to be commercial speech.138 the nutrition facts label presents a commercial transaction for purchase; therefore even if it contains the added sugar disclosure, it is likely commercial speech. b. zauderer or central hudson after the determination that the added sugar disclosure is commercial speech, the next step is to evaluate whether the test from zauderer or central hudson should apply to a 135 melissa m. card, america, you are digging your grave with your spoon—should the fda tell you that on food labels?, 68 food & drug l.j. 309, 313 (2013). 136 id. 137 see int’l dairy foods ass’n v. boggs, 622 f.3d. 628, 635 (6th cir. 2010); see also card, supra note 135, at 314. 138 card, supra note 135, at 314. 256 indiana health law review vol. 13:1 first amendment challenge in this context. the determination is best made after quickly reviewing the recent case law involving commercial speech litigation discussed earlier. currently, courts are split as to which standard should be applied to commercial speech cases that involve labels of products regulated by the fda.139 1. central hudson standard analysis the central hudson standard was the most widely used standard for commercial speech cases in the past, but appears to have been used less often in recent cases. as previously discussed, the d.c. circuit applied the intermediate scrutiny test from central hudson to r.j. reynolds tobacco co. in 2012 to evaluate the fda’s proposed use of graphic warnings on the labels of tobacco products.140 under the central hudson standard, the d.c. circuit found the fda could not require this compelled speech in the form of graphic warnings on the labels.141 further, the court rejected using the zauderer standard because the graphic warnings were not “purely factual and uncontroversial.”142 when the fda promulgated the final rule for adding the disclosure of trans fats to the nutrition facts label, it included a brief central hudson analysis in response to many public comments that asserted the disclosure would not pass the intermediate scrutiny test.143 in the analysis, the fda claimed the disclosure would pass the first prong because the disclosure of trans fats is related to lawful activity and is not misleading.144 the disclosure also passed the second and third prongs because the mandatory trans fat disclosure directly advanced the substantial interests of protecting and promoting public health, as well as preventing consumer deception.145 139 id. 140 see generally r.j. reynolds tobacco co. v. fda, 696 f.3d. 1205 (d.c. cir. 2012). 141 id. 142 id. 143 trans fatty acids, supra note 36, at 41439. 144 id. 145 id. at 41439-41440. 2016 257 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members 2. zauderer standard contrary to r.j. reynolds tobacco, the d.c. circuit held american meat institute v. usda to the zauderer standard in the summer of 2014.146 the court’s decision shifted from the use of central hudson by finding that zauderer can apply to speech beyond situations of deception.147 the court also found that zauderer could be extended to disclosures that are required to serve government interests other than preventing deception.148 finally, the d.c. circuit made a point to state that it now overrules the cases where zauderer is read to only apply to disclosures where the government’s interest is correcting deception.149 the sixth circuit also applied zauderer to commercial speech cases that involve compelled speech through label disclosures. in international dairy, the court evaluated a disclosure requirement on dairy products that claimed to be “rbst free” under zauderer in 2010.150 the sixth circuit found zauderer to be the appropriate standard because it is applicable to disclosures that are required based on the government’s interest to correct potentially misleading speech and not just inherently misleading speech.151 because litigation arising from compelled disclosures on food labels has most recently been decided under zauderer, it appears that a court would hold the added sugar disclosure to the same standard. the court’s effort in american meat institute that overruled the cases that only apply zauderer to cases to correct deception is dispositive in the determination of which standard a court would apply to the added sugar disclosure, even though the fda previously used the central hudson standard to self evaluate a mandatory disclosure. further, the fda even stated in their self-evaluation of the trans fat disclosure that the disclosure 146 am. meat inst., v. united states dep’t of agric., 760 f.3d. 18, at 20 (d.c. cir. 2014). 147 id. 148 id. at 21. 149 id. at 22. 150 int’l dairy foods ass’n v. boggs, 622 f.3d. 628, 640 (6th cir. 2010). 151 id. at 641. 258 indiana health law review vol. 13:1 likely did not need to be analyzed under the intermediate scrutiny test from central hudson.152 additionally, judge rodgers expressed his dissatisfaction with the use of central hudson in his dissent in r.j. reynolds tobacco, stating that zauderer should have applied instead.153 rodgers’ assertion that central hudson was not appropriate to evaluate the graphic warning labels supports a finding that zauderer is the correct standard for analyzing the less dramatic added sugar disclosure proposed by the fda. further, the fact that the public comments asserted central hudson as the standard to be applied to the disclosure does not weigh on the analysis in this note.154 the added sugar disclosure is purely factual and uncontroversial and even though the government’s interest in the disclosure may be beyond correcting deception, american meat institute opened the door for zauderer to be extended to government interests beyond correcting deception. c. zauderer first amendment analysis after establishing zauderer as the appropriate standard to evaluate the added sugar disclosure, each of the five factors of the reasonable relationship test should be applied to the added sugar disclosure. 152 trans fatty acids, supra note 36, at 41440. 153 r.j. reynolds tobacco co. v. fda, 696 f.3d. 1205, 1222 (d.c. cir. 2012) (rodgers, j., dissenting) (“[i]n affirming the grant of summary judgment to the tobacco companies, the court applies the wrong level of scrutiny”). 154 public comment from the corn refiner’s association on proposed rule: food labeling: revision of the nutrition and supplement facts labels (aug. 1, 2014), available at http://www.regulations.gov/ #!documentdetail;d=fda-2012-n-1210-0455 [http://perma.cc/8lk6y3h2]v9l2-xq6y]. the association attempts to claim that the added sugar disclosure would fail on all four prongs of the central hudson test and zauderer cannot apply because the fda has failed to show any value the disclosure of added sugar would provide for consumers. 2016 259 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members 1. purely factual the first prong of the zauderer test is to determine whether the disclosure is purely factual.155 zauderer demonstrates that disclosures or speech that contain accurate, factual information are considered to be purely factual.156 based on this description of purely factual, it appears the added sugar disclosure passes the first prong. the fda’s proposed disclosure requires a statement of the amount of sugar the food manufacturer has contributed to the product, which is simple, factual information.157 a comparison of the added sugar disclosure with the country-of-origin disclosure provides further support for the fda’s purely factual argument. the two disclosures appear to be comparable because of the similar basic structure of each disclosure. the country-of-origin disclosure was an undisputed simple, accurate statement regarding the location of origin of a meat product, held by the court to be purely factual.158 the added sugar disclosure is the same type of simple, accurate information as the country-of-origin disclosure and should therefore also be considered purely factual. the added sugar disclosure should also be considered purely factual when compared to the graphic warning labels on tobacco products that judge rodgers claimed to be factual in his dissent.159 2. uncontroversial the second prong in the zauderer reasonable relationship test is to determine whether the disclosure or speech is uncontroversial.160 the fda may have the most difficultly 155 dhooge, supra note 37, at 624. 156 id. 157 food labeling, supra note 14, at 11884. 158 am. meat inst. v. united states dep’t of agric., 760 f.3d. at 18, 20 (d.c. cir. 2014). 159 r.j. reynolds tobacco co. v. fda, 696 f.3d. 1205, 1222 (d.c. cir. 2012) (rodgers, j., dissenting). 160 dhooge, supra note 37, at 624. 260 indiana health law review vol. 13:1 passing this prong because many food industry members strongly oppose the added sugar disclosure as highly controversial in the public comments. the fda relied on scientific evidence that “many foods and beverages that are major sources of added sugars have low levels of nutrients, such as vitamins” to support its assertion that the added sugar disclosure is uncontroversial.161 the fda asserted the added sugar disclosure is uncontroversial because consumers may incorrectly believe foods to be full of vitamins and nutrients that are in fact diminished when the sugar was added to the food.162 although the fda relied on scientific evidence to support the disclosure as uncontroversial, the opponents argue there is a lack of evidence to support the added sugar disclosure. the sugar association, one of the major opponents of the disclosure, claimed that when the dietary guidelines for americans council made their determination that added sugars contribute to obesity, weight gain, and heart disease in 2010, there was no strong or conclusive evidence to support the findings.163 however, a 2015 scientific report released by the dietary guidelines advisory committee provided evidence “suggesting a strong association between a dietary pattern of intake characterized, in part, by a reduced intake of added sugars and a reduced risk of cardiovascular disease.”164 further, some opponents claimed there was a lack of evidence to show the body processes added sugar any differently than natural sugars—an assertion the fda did 161 proposed nutrition facts label changes are based on science and research, u.s. food and drug administration, available at http://www.fda.gov/forconsumers/consumerupdates/ucm387164.htm [http://perma.cc/q4pk-bcl7] (last updated sept. 1, 2015) [hereinafter “science and research”]. 162 id. 163 the sugar association calls for withdrawal of ‘added sugars’ labeling proposal in comments filed to fda, the sugar association (jul. 31, 2014), http://www.sugar.org/sugar-association-calls-withdrawaladded-sugars-labeling-proposal-comments-filed-fda/ [http://perma.cc/9lc8-cbue] [hereinafter “sugar association”]. 164 supplemental proposed rule, supra note 20, at 44303. 2016 261 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members not dispute when it published the proposed rule.165 although the fda conceded on this issue, supporters of the added sugar disclosure countered the argument with an assertion that even if there is “no differing physiological effect for added versus naturally present sugar,” lack of differing effects is not a relevant point to the required disclosure.166 instead, supporters asserted the main point of the disclosure is to bring attention to the overconsumption of sugar among consumers.167 if such an assertion is accepted as true, the disclosure is not controversial when used to encourage consumer awareness.168 the similar country-of-origin disclosure was considered uncontroversial because there was no dispute over the truth of the facts contained in the disclosure. 169 it does not appear that the opposition to the added sugar disclosure disputes the truthfulness of the amount of added sugar in a product; therefore the added sugar disclosure is uncontroversial as well. further, the added sugar disclosure is much less radical than the proposed graphic warning label that tobacco companies found to be very controversial. 3. legitimate government interest the third prong of the reasonable relationship test from zauderer requires a legitimate government interest for compelling the disclosure.170 the fda asserted several interests to support the added sugar disclosure, but perhaps the most legitimate was to improve consumer health and 165 food labeling, supra note 14, at 11905 (noting “[w]e continue to recognize the lack of a physiological distinction between added and naturally occurring sugars.”). 166 gretchen goldman, five things sugar interests get wrong about fda added sugars labeling, food safety news (jul. 3, 2014), http://www.foodsafetynews.com/2014/07/goldman-contributed/#.vfpky_ nf-nf [http://perma.cc/3wxd-jppu]. 167 id. 168 id. 169 see am. meat inst., v. united states dep’t of agric., 760 f.3d. at 27 (d.c. cir. 2014). 170 dhooge, supra note 37, at 624. 262 indiana health law review vol. 13:1 access to healthy food choices.171 americans are facing a health crisis with the rise of the obesity epidemic, despite the government’s efforts to alleviate the crisis. current data reveals about sixty-eight percent of adults are overweight or obese172—which in turns leads to high rates of other chronic diseases, such as heart disease, type ii diabetes and even some types of cancer.173 the chronic diseases typically caused as a result of obesity are currently the leading causes of death in the united states.174 society as a whole has an interest in reducing the obesity rate. the fda has set out to take part in reducing the obesity rate through the update of a nutrition facts label to “help consumers make informed food choices to consume a nutritionally adequate diet while monitoring calorie intake and lowering their risk of some chronic diseases.”175 consumers are in need of additional information in order to efficiently make healthy choices for a healthy lifestyle. the additional information is most efficient if it is available to consumers on the labels, and therefore the government has a legitimate interest in requiring the disclosure of added sugar.176 the interest of improving consumer health through availability of necessary information on added sugar is supported by evidence from the dietary guidelines for americans council that revealed “added sugars . . . make[s] up a significant percentage of the american diet and are a source of excess calories.”177 the government asserted a similar interest in providing the necessary tools for consumers to make informed and healthy choices by implementing the country-of-origin disclosure. there was a legitimate government interest to provide consumers with information that would give them 171 food labeling, supra note 14, at 11881. 172 id. at 11885. 173 id. (“an estimated 37 percent of americans suffer from cardiovascular disease (cvd), 11.3 percent of the population 20 years and older has diabetes, 35 percent of adults has pre-diabetes, and 41 percent of the population is predicted to be diagnosed with cancer during their lifetime.”). 174 id. 175 id. 176 id. 177 id. at 11904. 2016 263 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members the opportunity to choose to purchase american raised meat through a disclosure similar to the added sugar disclosure.178 in addition to improving consumer health and increasing access to healthier food choices, the government has an interest in encouraging changes in food processing, a change endorsed by supporters such as the obesity society.179 the food industry has continually made changes to the way food is produced and manufactured since the introduction of the nutrition facts label through the nlea.180 with the rise in the obesity epidemic, it is important to continue to make the necessary changes to the make-up of food, and as the past has shown, disclosure of unhealthy ingredients is a good motivator of change for the food industry.181 the fda has an additional legitimate interest for requiring the disclosure of added sugars; the improvement of consumer awareness. as consumers become interested in reducing caloric intake and increasing the amount of nutrient dense foods, the government has a legitimate interest in supporting consumer interest through the added sugar disclosure.182 without including added sugar on the nutrition facts label, many consumers are unable to determine which foods are high in unnatural sugars and which are not—a consideration that strengthens the fda’s interest in promoting awareness.183 finally, the fda may have a legitimate government interest in preventing consumer deception. although 178 am. meat inst., v. united states dep’t of agric., 760 f.3d. at 18, 23 (d.c. cir. 2014) (the “context and long history of country of origin disclosures to enable consumers to choose american made products.”). 179 the obesity society supports all proposed changes to food nutrition facts labels and commends the u.s. food & drug administration for the much-needed update, the obesity society (may 15, 2014), http://www.obesity.org/proposed-major-revision-to-foodnutrition-facts-labels.htm [http://perma.cc/7wrg-hghn] [hereinafter obesity society]. 180 proposed changes, supra note 4. 181 id. an example of a disclosure that led to an improved formulation of food products is when the fda began requiring the amount of trans fats on the nutrition facts label, the amount food manufacturers used decreased. 182 food labeling, supra note 14, at 11905. 183 id. at 11904. 264 indiana health law review vol. 13:1 american meat institute allows disclosures that are not aimed at preventing or correcting deception to be held to the zauderer standard,184 it may still be one of the fda’s purposes for requiring the added sugar disclosure. as discussed earlier, consumers may incorrectly assume that a food does not contain added sugar because of a front of package label that categorizes the food as healthy.185 the added sugar disclosure allows consumers to correctly identify foods that contain added sugar versus natural sugar, and avoid mistaking a food as healthy when it actually contains a high amount of added sugar. in summary, there is a legitimate government interest in requiring the disclosure of added sugar on the nutrition facts label because of the need to improve consumer health and access to healthier food choices. additionally, there is a legitimate interest in improving the way food is manufactured, as well as improving consumer awareness of the ingredients in food through the disclosure of added sugar. finally, the fda has an interest in preventing potential consumer deception. 4. disclosure must be reasonably related the fourth prong of the reasonable relationship test from zauderer requires the added sugar disclosure to be reasonably related to the legitimate government interests asserted in the third prong.186 first, the added sugar disclosure is reasonably related to the government interest of improving consumer awareness because evidence reveals that many consumers actually read and use the nutrition facts label.187 in fact, the number of consumers that report reading the nutrition facts labels increased ten percent in 184 am. meat inst. v. united states dep’t of agric., 760 f.3d. 18, 20 (d.c. cir. 2014). 185 point of package labeling, supra note 25. 186 dhooge, supra note 37, at 624. 187 see food labeling, supra note 14, at 11887. 2016 265 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members six years.188 the increase is confirmation that the disclosure will affect more consumers than the food industry believes.189 further, the added sugar disclosure on the nutrition facts label is reasonably related to the government interest of improving consumer awareness because the flow of information is an important method of creating awareness. without the amount of added sugar on the nutrition facts label, the consumer would not be able to discern between naturally and unnaturally occurring sugars in a food product, thus hindering their ability to make informed decisions when searching for healthy food choices.190 the added sugar disclosure is reasonably related to the government interest of changing the way food is processed. by improving the way food is processed, more healthy food options with less added sugar will be available for consumers. the increased availability of healthy foods will improve access to healthy choices, as well as improve overall consumer health.191 in addition to improving access and health, history has shown that requiring the disclosure of an unhealthy ingredient is related to altering the way some foods are produced. when the fda began requiring the disclosure of trans fats in 2003, the amount of trans fats that food manufacturers used lowered dramatically and in some cases was completely removed from foods.192 before declaring the disclosure reasonably related to the legitimate interests, it is important to consider the opposition’s reasoning for why the disclosure is not reasonably related to the government interest. the opposition attacks the fda’s main interest of improving consumer health because the disclosure is not reasonably related to improving health through a reduction of excess calorie consumption due to added sugar intake.193 the sugar 188 see id. (“the percentage of consumers reporting that they often read a food label the first time they purchase a food product rose from 44 percent in 2002 to 54 percent in 2008.”). 189 id. 190 food labeling, supra note 14, at 11904. 191 proposed changes, supra note 4. 192 goldman, supra note 166. 193 sugar association, supra note 163. 266 indiana health law review vol. 13:1 association highlights there is no official recommendation for the amount of added sugar individuals should consume.194 further, they assert the “average american consumes 300 calories of added sugar per day”195 and therefore the disclosure will only affect a small number of consumers and is not reasonably related to the government interests.196 however, the 2015 scientific report of the dietary guidelines advisory committee made a recommendation to limit added sugar intake to less than ten percent of overall caloric intake.197 although the opposition provides valid arguments to consider, the arguments do not outweigh the support that the disclosure is reasonably related to the government interests. the fda also has support for their argument from the d.c. circuit’s finding that the country-of-origin disclosure was reasonably related to the legitimate government interests.198 the d.c. circuit pointed out the disclosures were reasonably related to legitimate interests when they provided “purely factual and uncontroversial information about attributes of the product or service being offered.”199 because the added sugar disclosure is similar to the country of origin disclosure and has already been determined to be purely factual and uncontroversial, the added sugar disclosure is reasonably related to the fda’s legitimate interests. the added sugar disclosure is reasonably related to the legitimate interests of improving consumer health through enhancing awareness of food content and access to healthy food options, as well as encouraging change in the way food is produced and manufactured. accordingly, the disclosure will move on to the fifth and final prong of the reasonable relationship test. 194 id. 195 tavernise, supra note 21. 196 id. 197 supplemental proposed rule supra note 20, at 44308. 198 see am. meat inst. v. united states dep’t of agric., 760 f.3d. 18, 26 (d.c. cir. 2014). 199 id. (the court also stated that a disclosure will usually be reasonably related to the government interests, “absent a showing that the disclosure is ‘unduly burdensome’ in a way that ‘chill[s] protected commercial speech,’”) (quoting edenfeld v. fane, 507 u.s. 761, 651 (1993)). 2016 267 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members 5. disclosure is not unjustified or unduly burdensome the fifth and final prong of the reasonable relationship test from zauderer requires that the disclosure is not unjustified or unduly burdensome. to determine whether or not the added sugar disclosure is unjustified or unduly burdensome, the analysis begins by examining some of the reasons why opponents argue the disclosure is unjustified or unduly burdensome. first, opponents asserted there is no analytical method to distinguish between added and naturally occurring sugars in a food.200 the same opponents also raised the argument that there is no analytical method to distinguish between the two types of sugars, therefore disclosure would require “unprecedented record keeping,” that would be unduly burdensome on food manufacturers.201 the fda and supporters of the added sugar disclosure reject the sugar association’s claims with several points. first, the fda and supporters assert that since manufacturers are responsible for adding the extra sugar to the food products, they should have an idea of how much sugar is added during processing.202 if manufacturers have knowledge of the amount of added sugar they are adding during processing, there is no need for analytical methods that would lead to burdensome record keeping.203 the fda also asserted that the alleged lack of analytical methods should not preclude the promulgation of a final rule because the fda could achieve the record keeping through maintenance and record review.204 further, the fda has required similar record keeping in the past for food products, 200 sugar association, supra note 163. 201 id. the sugar association asserts the disclosure cannot be enforced without such “unprecedented record keeping and inspection requirements.” 202 goldman, supra note 166. 203 id. 204 food labeling, supra note 14 at 11905. (the fda has requested the review of records for values of dietary fiber, folate, and vitamin e under certain circumstances, implying the records will not be used solely for review of added sugars.) 268 indiana health law review vol. 13:1 which rejects the opponents’ idea that the record keeping would be unprecedented.205 in addition to the sugar association’s burdensome record keeping argument, other opponents of the disclosure claimed it is unjustified because it may deceive consumers into purchasing foods that may be lower in added sugar but are actually higher in calories and fat.206 the opponents also alleged that the extra line for added sugar on the label would confuse consumers because they may add the two lines of sugar together.207 if consumers add both sugar lines together, they may be misled into believing a product contains more sugar than it actually does.208 the fda conceded on the issue of initial confusion, but instead asserted the lack of consumer understanding about how to read the two sugar lines will be resolved with consumer education over time.209 the fda’s idea for such education is through consumer studies in the form of questionnaires on the understanding of the use of the added sugar disclosure.210 the fda maintained that the consumer studies would be referred to for future actions related to the added sugar disclosure.211 as support for resolving the consumer confusion, the fda’s consumer studies were completed before the publishing of the 2015 revisions and revealed that the majority of consumers were able to correctly identify the amount of total sugar and added sugar when both were listed separately on the label.212 finally, the fda asserted the disclosure is not unjustified or unduly burdensome because of the generous amount of 205 id. (requiring record keeping with respect to the aeration to reduce fat in foods). 206 sugar association, supra note 163. 207 lammi, supra note 32. 208 id. 209 food labeling, supra note 14, at 11905. (the fda has previously used explanatory footnotes on labels, such as describing the amount of calories the daily value percentage is based on. additionally, the fda emphasizes that the two sugar lines are independent of each other and are necessary for consumers to compare the amount of added sugar in different foods.). 210 id. at 11905. 211 id. 212 supplemental proposed rule supra note 20, at 44306. 2016 269 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members time being allotted for food industry members to become compliant with a final rule.213 the time for implementation for the proposed rule, including the added sugar disclosure is two years from the date of the implementation of a final rule.214 the disclosure of added sugar on the nutrition facts label passes the final prong of the reasonable relationship test because it is not unjustified or unduly burdensome. food manufacturers should be able to record the amount of added sugar included in food products during processing because the fda has required similar record keeping requirements in the past related to food labeling. additionally, the disclosure is not unjustified or unduly burdensome because the fda plans to address the possible consumer confusion with educational pieces to describe how to read the new nutrition facts label. finally, the fda has granted a generous amount of time for food manufacturers to become compliant with the final rule.215 in conclusion, the disclosure is not unjustified or unduly burdensome. d. final policy reasons for implementing the proposed rule despite the threat of first amendment litigation from food industry members and regardless of the standard used to analyze the added sugar mandatory disclosure in anticipation litigation, there are a number of policy reasons for why the fda should promulgate a final rule. the need for updated nutrition facts labels is essential to public health. commentators point out that americans have the “sweetest diet in the world” and the added sugar disclosure is necessary to make consumers aware of this diet.216 additionally, one of the fda’s goals behind the updated label is to empower consumers to make healthy choices, 213 id. at 11882. 214 id. 215 food labeling, supra note 14, at 11959 (manufacturers have two years from the effective date of a final rule to be in compliance with the regulations.). 216 tavernise, supra note 21. 270 indiana health law review vol. 13:1 rather than explicitly telling consumers what they should eat.217 in a society that is constantly seeking transparency from the government, consumers should have the opportunity to make an educated decision on whether or not to consume a glass of apple juice if it contains ten grams of added sugar. further, consumers should be able to make such educated decisions without a complex educational background in nutrition science.218 the update to the nutrition facts label provides a simplified label that allows consumers to determine whether the sugar in fruit juice came from the fruit itself, without having to interpret scientific names for sugar in the ingredients list. finally, food labeling practices and policies should be updated every so often in order to remain effective. as technology changes and more is learned about the way certain foods affect individual health, the information that is presented to consumers must also be updated.219 as consumer lifestyles and food consumption trends change, the information provided to the consumer must reflect these changes.220 the policy reasons for including the added sugar disclosure provide further support for the fda to march on with a final rule implementing the disclosure, along with the rest of the proposed changes to the nutrition facts label. iv. conclusion the added sugar disclosure on the nutrition facts label, as proposed in “food labeling: revision of the nutrition and supplement facts label,” will be analyzed under the more lenient reasonable relationship test created in zauderer.221 american meat institute frames the standard so that it can 217 obesity society, supra note 179. 218 tavernise, supra note 21. (first lady michelle obama emphasized the importance of enabling consumers to be able to look at products at the grocery store and quickly determine whether it is a healthy choice). 219 see science and research supra note 161. 220 id. 221 see id. 2016 271 yes, the fda can make you say that: why the fda’s proposed nutrition facts label changes will withstand first amendment challenges from food industry members be applied in cases where the government has an interest beyond preventing consumer deception through purely factual information,222 such as the added sugar disclosure. while the opponents of the added sugar disclosure may have some compelling arguments, the fda’s proposed rule will still withstand first amendment challenges because it passes the five prongs of the reasonable relationship test from zauderer. the disclosure is purely factual and uncontroversial and the government has a legitimate interest in mandating the disclosure. the added sugar disclosure is reasonably related to the legitimate interests and finally, the disclosure is not unjustified or unduly burdensome. in addition to passing the zauderer test, it is apparent the updated nutrition facts label is necessary as one of many steps to help combat the obesity crisis the united states is currently facing. even without a first amendment analysis under either standard, the fda should press on with a final rule, based on the strong policy reasons. with such a frightening obesity crisis, even the slightest chance that the updated nutrition facts label will motivate consumer change should be enough to move forward with the rule. finally, the fda could take the same cautious step it took when promulgating the trans fat disclosure by including a zauderer analysis in the published final rule. such an analysis would be in response to the public comments that assert first amendment violations. however, even without such an analysis in the final rule, the added sugar disclosure will likely withstand first amendment challenges because of the legitimate public health need for the disclosure.223 222 am. meat inst., v. united states dep’t of agric., 760 f.3d. 18, at 22 (d.c. cir. 2014). 223 tavernise, supra note 21 (referring to president george bush’s statement that the proposed changes are “one of the most important public health upgrades in this decade”). a dose of reality: unintended consequences of penalizing hospital readmissions in the ppaca joel d. swider* i. introduction ....................................................................................... 361 ii. roadmap ........................................................... ; .................................. 362 iii. overview of problem ...................................................................... 362 a. decrease in care quality ....................................................... 363 b. decrease in minority access to care ... : ................................ ;.363 c. increased hospital financial distress ............................ ; ..•.... 364 n. background ................................................ :: .. : ................................. 366 v. statute ................................................................ ; ............................ ~.368 vi. intended consequences .......................................... ;; ..................... 373 vii. unintended consequences ........................................................... 375 · viii. proposed solutions to readmissions-what is a provider to do? ........................................................................................ 377 ix. policy implications of readmissions reduction ...................... 381 x. proposed solutions .......................................................................... 385 xi. conclusion ....................................................................................... 388 i. introduction empirical evidence indicates that the hospital readmissions reduction provision of the patient protection and affordable care act of 20101 ("ppaca" or "affordable care act'} will likely reduce medicare costs over the long term.2 however, this provision also will likely lead to unin­ tended increases in hospital bankruptcies, decreases in quality of care, and decreases in access to care for minority populations. *j.d. candidate, 2012, indiana university robert h. mckinney school of law; b.a., 2008, university of virginia. the author wishes to thank his wife victoria for her patience and support; bruce jones, j.d., for his insightful tutelage and meticulous revisions; and john clark. m.d., j.d., for sharing his wealth ofknowledge and practical expertise. i. patient protection and affordable care act of 2010, pub. l. no. ll1-148, 124 stat. 119 (2010). 2. letter from douglas w. ell)lendorf, dir., congressional budget office, to nancy pelosi, speaker, u.s. house of representatives, providing a final cost estimate of the direct spending and revenue effects of the patient protection and affordable care act 26 (mar. 20, 20 l 0), available at http://www.cbo.gov/ftpdocs/113xx/docll379/ amendreconprop.pdf. 362 indiana health law review [vol. 9:1 ii. roadmap this note will first provide a definition for what constitutes hospital "readmissions" under the affordable care act. next, it will highlight the economic harm readmissions pose to federal spending and reining in the budget deficit. third, this note will explain congress' proposed solution to this problem-namely, the hospital readmissions reduction program­ and its intended outcome of reducing medicare costs. the majority of this note will then consist in analyzing the unintended consequences on hospi­ tals and patients, both directly and indirectly, using interviews with indiana hospital administrators and published data regarding the successful read­ missions reduction efforts of various states and hospitals.3 the note will conclude by offering possible improvements on the current state of the hospital readmissions reduction program. iii. overview of problem the phenomenon of hospital readmissions is a prevalent and costly one. according to a 2009 study in the new england journal of medicine, almost one-fifth (19.6%) ofhospitalized medicare patients are readmitted to a hospital within 30 days of their initial stay.4 in 2004, unplanned rehospi­ talizations cost taxpayers roughly $17.4 billion of the total $102.6 billion the government disbursed for medicare. 5 all told, nearly seventeen percent of the medicare budget was spent on unplanned readmissions.6 congress attempted to address this problem as part of the recently passed affordable care act.7 the particular provision, the so-called "hos­ pital readmissions reduction program'.s ("hrrp" or "program") goes into effect october 1, 2012, and stipulates that the government will begin tore­ duce the amount it pays to hospitals with "excess readmissions"9 of pa­ tients. the congressional budget office ("cbo") predicts that this program 3. see state health watch, colorado medicaid set to save millions on readmis­ sions, pharmacy choice (july 1, 2010), http://www.pharmacychoice.com/news/article. cfm? article_ 10=605072. 4. stephen f. jencks et al., rehospitalizations among patients in the medicare fee­ for-service program, 360 new eng. j. med. 1418, 1426 (2009). 5. ann carms, health reform takes aim at hospital readmission rates, us news & worw report (july 21, 2010), http://health.usnews.com/health-newslbest-hospitals/ articles/201 0/07/21/health-reform-takes-aim-at-hospital-readmission-rates.html. 6. 17.4 + 102.6 = 16.96%. 7. patient protection and affordable care act of2010, pub. l. no. 111-148, 124 stat. 119 (2010). 8. patient protection and affordable care act of2010, pub. l. no. 111-148, § 3025, 124 stat. 119, 408 (2010) amended by § 10309, 124 stat. 119, 942 (2010) (codified as amended at 42 u.s.c. § 1395ww(q) (2010)). 9. seegenerally42 u.s.c. § 1395ww(q)(4)(c)(2010). 2012] consequences of penalizing hospital readmissions 363 alone will save medicare an aggregate $7.1 billion by fiscal year 2019.10 however, the measure may have at least three unintended consequences: (a) a decrease in quality of care; (b) a decrease in access to care for minori­ ties; and (c) an increase in hospital financial distress, including increased prevalence of bankruptcy. a. decrease in care quality cash-strapped hospitals will need to conserve as much federal money as they can, which may create a conflict of interest between quality of care delivered and hospital bottom lines. in an interview with the national law journal, anna grizzle, a partner at bass, berry, and sims in nashville, tennessee, who represents health care providers, explained that cost-cutting will be "crucial" to the survival of publicly funded hospitals in the era of the affordable care act. u she anticipates that hospitals will be faced with more difficult dilemmas as to who should receive care and under what con­ ditions: "[f]or example, a patient who comes in with a heart attack, is that person readmitted for care?"12 the humanitarian in us hopes so; however, under the affordable care act, the hospital will be penalized for this read­ mission. therefore, hospitals will "need to look for ways to ensure those patients are not readmitted.''13 this may create a kind of race to the bottom in which hospitals are forced to cut back on services in order to remain via­ ble. indeed, a new england journal of medicine study published in de­ cember 2011 found, somewhat paradoxically, that there was "a substantial association" between "overall [hospital] admission rates" and "rates of re­ hospitalization."14 the study indicated that "lower utilization of hospital services might be more successful in reducing readmissions"15 than other methods tried to date. b. decrease in minority access to care beyond the problem of care quality lies the troubling fact that read­ missions tend to be higher in hospitals that treat a greater proportion of af10. letter from douglas w. elmendorf, dir., congressional budget office, to nancy pelosi, speaker, u.s. house of representatives, providing a final cost estimate of the direct spending and revenue effects of the patient protection and affordable care act 26 (mar. 20, 2010), available at http://www.cbo.gov/ftpdocs/ll3xx/docl1379/amendreconprop.pdf. 11. amanda bronstad, suit over hospital's closure could be a harbinger, nat'l l.j. (aug. 23, 2010), http://www.law.com/jsp/nlj/pubarticlenu.jsp?id=1202470936728& sire­ turn= 1&hbxlogin'"' 1 #. 12. /d. 13. /d. 14. arnold m. epstein et al., the relationship between hospital admission rates and rehospitalizations, 365 new eng. j. med. 2287,2287 (2011). 15. /d. 364 indiana health law review [vol. 9:1 rican-americans and needy patients.16 this situation makes sense consider­ ing the direct correlation between inferior socio-economic conditions and poor population health.17 in addition, patients who are beneficiaries ofboth medicare and medicaid-a status known as dual-eligibility-are monitored on a yearly basis, rather than a simple thirty-day cycle.18 thus, hospitals treating dual-eligible patients have an entire yearlong period during which to worry about preventing readmissions. dual-eligible patients also tend to be sicker than the average medicare enrollee.19 add to this the fact that more than half of public hospital patients are racial and ethnic minorities, 20 and it becomes· readily apparent that the hospitals that have the most to lose are those with higher minority and poor patient populations. if a communi­ ty hospital is experiencing increased pressure to cut patient services, then the entire community suffers. thus, the program may stand to dispropor­ tionately penalize public hospitals that are the most tasked with treating mi­ norities and the poor. c. increasedhospital financial distress · finally, in recent years, an increasing number of hospitals throughout the country have filed for bankmptcy.21 according to anna grizzle and 16. karen e. joynt et al., thirty-day readmission rates for medicare beneficiaries by race and site pf care, 305 jama 675, 675 (2011 ); richard cooper, hospital readmis­ sion policy flawed, action for better healrncare bloo (aug. 13,. 2010), http://actionforbetterhealthcare.com/?p=l067; see also roxana guilford-blake, medicaid status, race linked with hospital readmissions, healrnleaders media, oct. 15, 2010, http://v.ww.liealthleadersmedia.com/content!led-257766/medicaid-status-race-linked­ with-hospital-readmissions (finding that, after adjustments for other variables, being afri­ can-american raises risk of readmission by forty-three percent and being a medicaid benefi­ ciary raises risk of readmission by fifteen percent); but see lena m. chen et al., hospital cost of care, quality of care, and readmission rates: penny-wise and pound-foolish?, 170 archives internal med. 340, 340 (2010) (finding limited evidence to support the "penny-wise and pound-foolish" hypothesis: that low-cost hospitals discharge patients earli­ er but have higher readmission rates and greater downstream inpatient costs). 17. for an analysis of the relationship between poverty and ill-health, see adam wagstaff, poverty and health sector inequalities, 80(2) bull. world healrn org. 97, 97100 (2002), available at http://www.who.int/docstore/bulletin/pdf/2002/bul-2-e-2002/80% 282o/o2997-1 05.pdf. 18. telephone interview with john clark, medical director of clinical informatics, indiana university health (feb. 2, 2011 ). 19. medicare payment advisory comm'n, report to 1he congress: medicare and 1he healrn care delivery system 123 (2011), available at http://www.medpac.gov/ documents/jun11_entirereport.pdf, telephone interview with john clark, medical director of clinical informatics, indiana university health (feb. 2, 2011). 20. marsha regenstein & donna sickler, nat'l ass'n of pub. hosp. & heal1h sys., race, bthnicity, and language of patients: hospital practices regarding collection of information to address disparitles in healrn care ix (2006), available at http://www.naph.org/main-menu-category/our-work/health-care-disparities/race eth­ nicityandlanguageofpatients.aspx?ft=.pdf. 21. bronstad, supra note 11. 2012] consequences of penalizing hospital readmissions 365 others, this is due to mounting and unsustainable pressures on hospitals to cut costs.22 these pressures include growing costs, decreasing revenues, and unsustainable debt loads.23 a new york city hospital executive was quoted as saying, if you've accumulated any reserve over time, the first thing you do is eat it up.· then you cut costs on staff­ ing and support services, sometimes below levels you know are safe. then you stop spending money to keep your physical plant and equipment up to date ... . then, when there's nothing else you can do, you de­ clare bankruptcy?~ the danger then becomes that "[r]emaining hospitals, struggling to cope with the costs imposed by an influx of new, mostly poor patients left behind by the places that shut down, will increasingly be overcrowded and understaffed. services will be curtailed. facilities will be degraded. long waits and uneven care could become the norm. "25 grizzle likewise predicts that pressures such as these are set to intensify with the implementation of the hrrp?6 although lawmakers may have been unaware of these unintended consequences at the time the affordable care act was passed,27 many of these same criticisms were brought before the centers for medicare and medicaid services ("cms") during the notice-and-comment period28 prior to publishing its final rule29 regarding the hrrp. since cms changed al­ most nothing about the program between issuing the proposed rule and the 22. !d. 23. mark levine, st. vincent's is the lehman brothers of hospitals, n.y. mag., oct. 17, 2010, available at http://nymag.com/news/features/68991!. 24. jd 25. ld 26. bronstad, supra note 11. 27. see, e.g., jordan fabian, key senate democrat suggests that he didn't read en­ tire healthcare reform bill, 1he hill's blog briefing room (aug. 25, 2010, 09:40am), http://thehill.com/blogs/blog-brieting-roornlnews/115749-sen-baucus-suggests-he-did-not­ read-entire-health-bill; david freddoso, pelosi on health care: 'we have to pass the bill so you can find out what is in it ... ', wash. exam'r (mar. 9, 2010, 4:00 am), http://washingtonexaminer.com/blogslbeltway-confidentiallpelosi-health-care-039we-have­ pass-bill-so-you-can-find-out-what-it039. 28. see medicare program; proposed changes to the hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system and fiscal year 2012 rates, 76 fed. reg. 25,788 (proposed may 5, 2011) (to be codified at42 c.f.r. pts. 412,413, 476). 29. medicare program; hospital inpatient prospective payment systems fo.acute care hospitals and the long-term care hospital prospective payment system and fy 2012 rates; hospitals' fte resident caps for graduate medical education payment, 76 fed. reg. 51,476 (aug. 18, 2011) [hereinafter cms final rule] (to be codified at 42 c.f.r. pts. 412, 413, 476). 366 indiana health law review [vol. 9:1 final rule, lawmakers should amend the affordable care act to address the­ se issues in light of new research and other critical analyses. n. background the concept of hospital readmission (also called rehospitalization) is relatively simple and also relatively broad-a patient, upon discharge from a hospital, is soon thereafter readmitted to the same or a different hospital for the same or a different condition.30 the main problem with readmitting patients is that this "sometimes indicate[s] poor care or missed opportuni­ ties to better coordinate ca:re,.u1 especially if a readmission is unplanned and is related to the patient's original condition. research has indicated that excessive readmissions can be avoided through better communication between caregivers. and patients and better coordination of care following discharge.32 in its june 2007 report to congress, the medicare payment advisory commission (''medp ac") noted that medicare has not previously rewarded hospitals' efforts to reduce readmissions.33 to the contrary, medicare "pays for all admissions based on the patient's diagnosis regardless of whether it is an initial stay or a readmission for the same or a related condition.'.34 as a result, there is no incentive for hospitals to cut down on readmission rates. in fact, with its system of "case-based payments that reward hospitals for shorter lengths of stay,"35 hospitals are perhaps even "more likely to dis­ charge patients earlier," regardless of any increased risk of readmission. 36 this is a prevalent problem. in 2005, 6.2% of hospitalizations among medicare beneficiaries resulted in readmission within seven days, and 17.6% of hospitaliiations resulted. in readmission within thirty days. 37 a study in the new england journal of medicine pegged the rate of medicare beneficiaries requiring readmission· within thirty days of initial discharge even higher, at 19.6%, or almost one-fifth of patients.38 furthermore, 67.1% of patients discharged following a hospitalization related to a medi­ cal condition and 51.5% of those discharged after surgical procedures were 30. hospital readmissions meanlres, u.s. dep't of hbalm & human ser.vs., http://www.hospitalcompare.hhs.gov/staticpages/for-consumerslooc/readmission­ measures.aspx (last visited jan. 27, 2012). 31. medicare payment advisory comm'n, report to me congress: promoting greater efficiency in medicare 105 (2007), available at http://www.medpac.gov /documents/jun07 _ entirereport.pdf. 32. id 33. id 34. /d. 35. id. 36. id. at 105-6. 37. id at 107. 38 .. stephen f. jencks et al., rehospitalizations among patients in the medicare fee­ for-service program, 360 new eng. j. men. 1418, 1420 (2009). 2012] consequences of penalizing hospital readmissions 367 rehospitalized or died within a year. 39 this is also a very costly problem. in 2005, the average medicare payment for a ''potentially preventable readmission" was $7,200.40 re­ searchers have estimated that the aggregate medicare cost of unplanned rehospitalizations in 2004 was $17.4 billion.41 nonetheless, as evidenced by hospitals with comparatively lower rates of readmission, this problem is potentially a solvable one. for example, 2005 data shows that the fifteen-day readmission rate ranges from six per­ cent for hospitals in the top tenth percentile to double that, or twelve per­ cent, for hospitals in the ninetieth percentile.42 it should also be noted that readmission rates are affected in large part by the mix of cases a particular hospital sees.43 in light of this problem and its lack of a clear market-based solution, medp ac provided the framework for a two-step policy meant to address the problem of excessive readmissions through financial incentives that re­ ward hospitals for reducing their readmission numbers.44 the first prong of the suggested strategy is to collect and publicize data regarding hospital­ specific readmission rates for certain medical conditions.45 ''this will en­ sure that hospitals know their rates and how they compare with those of their peers and will allow beneficiaries and other providers to use this in­ formation when they make health care decisions or admit patients.'.46 as the second prong, medp ac recommends that, "[ a]fter a year or two, public disclosure could be complemented by a change in payment rates, so that hospitals with high risk-adjusted rates of readmission receive lower average per case payments.'o47 medpac declined to give any guidance as to how or at what rate these lower average case payments were to be meted out.48 medp ac also pointed out that holding each provider along the continuum49 accountable would be an "important parallel policy" to encourage decreas­ ing readmissions, since ultimate success in reducing readmission rates and attendant costs depends upon efficiency and coordination among all mem­ bers of the provider chain. 50 finally, medpac advocated payment incen39. /d. at 1421. 40. medicare payment advisory comm'n, supra note 31, at 108. 41. jencks et al., supra note 38, at 1426. 42. medicare payment advisory comm'n, supra note 31, at 108-9. 43. /d. at 109. 44. /d. at 103, 114. 45. /d. at 114. 46. /d. 47. /d. 48. id at 261. 49. the "continuum" of care encompasses the comprehensive array of health service professionals who see a given patient for treatment. this includes physicians, skilled nurs­ ing facilities, home health providers, and other providers. see medicare payment advisory comm'n, supra note 31, at 114. 50. medicare payment advisory comm'n, supra note 31, at 114. 368 indiana health law review [vol. 9:1 tives to reward quality care. 51 prior to passage of the affordable care act, cms began implement­ ing the first prong of the medp ac strategy. beginning in 2002, in associa­ tion with the hospital quality alliance, cms began collecting data from hospitals on a voluntary basis for the purpose of making "important infor­ mation about hospital performance accessible to the public and to inform and invigorate efforts to improve quality.'.s2 with passage of the afforda­ ble care act, cms began requiring hospitals that treat medicare patients to submit readmissions data, 53 specifically regarding three conditions: acute myocardial infarction (heart attack), congestive heart failure, and pneumo­ nia.54 this data is available on the cms "hospital compare" internet web­ site. 55 the website also includes a comparison of each hospital's statistics to national averages. while patients and potential patients have undoubted­ ly benefited through greater transparency and a larger volume of data to compare in making hospital decisions, the program lacked any real mecha­ nism to encourage hospitals to reduce readmissions until passage of the af­ fordable care act. v. statute heeding medpac's advice, 56 in 2010, congress attempted to address some of the problems with the state of hospital readmissions through pas­ sage of the affordable care act. 57 in particular, section 3025,58 as amended by section 1 030959-the "hospital readmissions reduction program•.60_ provides as follows: (1) in general. [b]eginning on or after october 1, 2012, in order to account for excess readmissions in 51. id. at 77, 114. 52. medicare hospital compare ,glossary, u.s. dep't of healtii and human servs., http:/lwww.hospitalcompare.hhs.gov/staticpageslhelplhospital-glossary.aspx?choice =h (last visited jan. 21, 2012). 53. 42 u.s.c. § 1395ww(q)(8)(b) (2010). 54. see changes to the hospital inpatient prospective payment systems and fiscal year 2009 rates, 73 fed. reg. 48,434,48,602 (aug. 19, 2008). 55. hospital compare, u.s. dep't of heal til and human servs., http://www. hos­ pitalcompare.hhs.gov/ (last updated jan. 26, 2012). 56. cms final rule, 76 fed. reg. 51,476, 51,778 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412, 413, 476); see generally medicare payment advisory comm'n, supra note31. 57. patient protection and affordable care act of 2010, pub. l. no. 111-148, 124 stat. 119 (2010). 58. patient protection and affordable care act o£2010, pub. l. no. 111-148, § 3025, 124 stat. 119 (2010) (codified as amended at 42 u.s.c. § 1395ww(q) (2010)). 59. patient protection and affordable care act of 2010, pub. l. no. 111-148, § 10309, 124 stat. 119 (2010)(codified as amended at 42 u.s.c. § 1395ww(q) (2010)). 60. 42 u.s.c. § 1395ww(q) (2010). 2012] consequences of penalizing hospital readmissions the hospital, the secretary shall make payments ... in an amount equal to the product of(a) the base operating drg payment amount ... for the discharge; and (b) the adjustment factor ... for the hospital for the fiscal year. (2) base operating drg ["diagnosis related group"] payment amount defined. (a) in general. [t]he term ''base operating drg payment amount" means, with respect to a hospital for a fiscal year-(i) the payment amount that would otherwise be made ... for discharge if this subsection did not apply · (3) adjustment factor. (b) ratio. the ratio described in this subpara­ graph for a hospital for an applicable period is equal to 1 minus the ratio of-(i) the aggregate payments for excess readmis· sions ... and (ii) the aggregate payments for all discharges .. (4) aggregate payments, excess readmission ratio de­ fined. for purposes of this subsection: (a) [t]he term "aggregate payments for excess re­ admissions" means, for a hospital for an applicable period, the sum, for applicable conditions ... , of the product, for each applicable condition, of-(i) the base operating drg payment amount for such hospital for such applicable period for such con­ dition; (ii) the number of admissions for such condi­ tion for such hospital for such applicable period; and (iii) the excess readmissions ratio . . . for such hospital for such applicable period minus l. (b) [t]he term "aggregate payments for all dis­ charges" means, for a hospital for an applicable peri­ od, the sum of the base operating drg payment amounts for all discharges for all conditions from such hospital for such applicable period. (c) excess readmission ratio. (i) [t]he term "excess readmissions ratio" means, with respect to an applicable condition for a hospital for an applicable 369 370 indiana health law review period, the ratio (but not less than 1.0) of(1) the risk adjusted readmissions based on actual readmissions ... for an applicable hospital for such condition with respect to such appli­ cable period; to (ii) the risk adjusted expected readmissions . . . for such hospital for such condition with respect to · such applicable period.61 [vol. 9:1 in other words, starting in fiscal year 2013, the typical, prospective di:­ agnosis related group ("drg") payment that medicare makes to a hospital will be reduced based on the number of readmissions at that hospital above the national average readmission rate62 for a particular condition. this payment reduction will apply to all medicare discharges for that condition, even those that did not result in a readmission.63 thus, once the threshold is met, the hospital is penalized whether or not it later curtails readmissions for the rest of that year. presently, drg payments are issued prospectively based on the phy­ sician's documentation of a patient's diagnosis.64 the u.s. department of health and human services ("hhs") also takes into account such things as prevailing wage rates in the hospital's geographic region.65 but these base amounts are always multiplied by the drg ''weight" as an adjustment fac­ tor, which varies depending on the national average standardized cost per case for a specific type of diagnosis. 66 the weights are generalized based on diagnosis because they are· intended to account for cost variations be­ tween different treatments for the same condition; some patients may re~ quire more costly care (for example, a longer-than-average hospital stay) while some patients may respond extremely well to less expensive treat61. /d. 62. there is actually nothing in the statute that mentions national averages per se, but drg payments are currently calculated based on such a scheme, and medpac's jun~ 2007 report to tlle congress, from which many of tlle ideas for tlle pp aca's readmissions reduc­ tion provision came, calculated expected rates as based on ''the average rate of readmission across all hospitals, controlling for all patient refined diagnosis related group and severity class of patients." presumably, tlle term "risk adjusted expected readmissions" takes into account a national average. see medicare payment advisory comm'n, supra note 31, at 111-12. 63. see 42 u.s.c. § 1395ww(q)(4xa) (2010) for tlle precise calculation. 64. social security act§ 1886(d), 42 u.s.c. § 1395ww(d) (2010); paul gottlobbr et al., u.s. dep't of health & human sbrvs., medicare hospital prospective payment system: how drg rates are calculated and updated 1, 5 (2001), available at http://oig.hhs.gov/oei/reports/oei-09-00-00200.pdt: · 65. paul gottlobbr et al., u.s. dep't of health and human sbrvs., medicare hospital prospective payment system: how drg rates are calculated and updated 6-7 (2001 ), available at http://oig.hhs.gov/oei/reports/oei-09-00-00200.pdt: 66. /d. at8. 2012] consequences of penalizing hospital readmissions 371 ment. 67 in the end, these payments should average out to properly reim­ burse the hospital for its costs of care. thus, the "excess readmissions ratio" limits the base operating drg payments in an amount equal to the ratio of actual readmissions to "ex­ pected readmissions.'.68 the statute does not give a definition of how ex­ pected readmissions should be calculated, but the cms final rule states that expected readmissions are the sum of ''the probability of readmission for each patient at an average hospital. ,.69 the probability of readmission is calculated using "[t]he intercept term for the model (the same for all hospi­ tals ... )" and "[t]he increase or decrease in the probability of readmission contributed by each of the patient's risk factors (risk adjustment coefficients multiplied by the patient's risk factors ... ).''70 the statute defines a "re­ admission" as, "in the case of an individual who is discharged from an ap­ plicable hospital, the admission of the individual to the same or another applicable hospital within a time period specified by the secretary from the date of such discharge.'.n the final rule provided that ''the time period specified ... is 30 days.'m within the three categories of so-called "endorsed measures,'m con­ gress carved out "exclusions for readmissions that are unrelated to the prior discharge (such as a planned readmission or transfer to another applicable hospital)."74 however, in 2015, the hhs secretary shall, to the extent prac­ ticable, expand the applicable conditions beyond the 3 conditions for which measures have been endorsed . . . to the additional 4 conditions that have been identified by the medicare payment advisory commission in its re­ port to congress in june 2007 and to other conditions and procedures as determined appropriate by the secretary. 75 these other ·~appropriate" conditions will be updated by the secretary of health and human services through regulations/6 but cms indicated that it initially still "plan[ s] to consider the remaining four conditions'm contemplated by medpac.78 these conditions include chronic obstructive 67. see generally id 68. 42 u.s.c. § 1395ww(q)(4)(c)(i)(2010). 69. cms final rule, 76 fed. reg. 51.476, 51,675 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412,413, 476). 70. /d. 71. 42 u.s.c. § 1395ww(q)(5)(e) (2010) (emphasis added). 72. cms final rule, 76 fed. reg. 51,476, 51,666 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412,413, 476). 73. 42 u.s.c. § 1395ww(q)(5)(a)(ii)(ll) (2010). the three endorsed measures are acute myocardial infarction, congestive hearhaihrre, and pneumonia. u.s. dep't of healm & human servs., supra note 55. 74. 42 u.s. c. § 1395ww(q)(5)(a)(ii)(ii) (2010). 75. 42 u.s. c. § 1395ww(q)(5)(b) (2010). 76. cms final rule, 76 fed. reg. 51,476, 51,664 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412,413, 476). 77. /d. 78. see medicare payment advisory comm'n, supra note 31. 372 indiana health law review [vol. 9:1 pulmonary disease (copd), coronary artery bypass graft surgery (cabg), percutaneous transluminal coronary angioplasty (ptca), and "other vascu­ lar" surgery admissions. 79 there are certain limited exemptions to the readmissions payment re­ duction for "sole community hospitals" and for "medicare-dependent, small rural hospitals.'.so hospitals which treat ''fewer than a minimum number (as determined by the secretary) of discharges for such applicable condition for the applicable period'.s1 are also exempt from the payment reduction. ap­ parently congress thought that the importance of maintaining access to the­ se hospitals outweighed the risk of possible service cutbacks or financial decline as a result of the program. finally, the affordable care act's hrrp82 includes a "floor adjust­ ment factor," which cannot be lower than 0.99 for fiscal year 2013, 0.98 for fiscal year 2014, or 0.97 for fiscal years 2015 and later.83 this means that the largest potential payment reduction a hospital could receive would be 1% in fiscal year 2013, 2% in fiscal year 2014, and 3% in fiscal years 2015 and beyond. 84 this "phased-in approach'.s5 allows hospitals some time to ease into the program and make adjustments before the full penalty kicks into effect. other provisions within the affordable care act require that, by march 2012, the hhs secretary develop ''reporting requirements" for use by health plans to "implement activities to prevent hospital readmissions through a comprehensive program for hospital discharge that includes pa­ tient-centered education and counseling, comprehensive discharge planning, and f,st discharge reinforcement by an appropriate health care profession­ al."8 some may say these reporting and concrete program implementation requirements should sugpiant, rather than augment, any requirement for total readmission rates. nonetheless, congress apparently saw both as important as it ultimately required both. there still exist some uncertainties regarding the exact details of the hrrp. although the cms regulations issued in august 2011 comprise a ''final rule,'.s8 there are a number of decisions the hhs secretary still must 79. ld at 116. 80. 42 u.s.c. § 1395ww(q)(2)(bxi) (2010). 81. 42 u.s.c. § 1395ww(q)(4xc)(ii) (2010). 82. see 42 u.s.c. § 1395ww(q) (2010). 83. 42 u.s.c. § 1395ww(q)(3)(c)(i)-(iii) (2010). 84. see sharon burnett, mo. hosp. ass'n, hospital readmissions reduction program 1 (2010), available at http://web.mbanet.com/userdocs/hospital_readmissions_ reduction_ program. pdf. 85. cms final rule, 76 fed. reg. 51,476, 51,662 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412,413, 476). 86. patient protection and affordable care act of 2010, pub. l. no. 111-148, § 2717(a)(1)(b), 124 stat. 119, 135 (2010). 87. see infra part x. 88. cms final rule, 76 fed. reg. 51,476, 51,664 (aug. 18, 2011) (to be codified at 2012] consequences of penalizing hospital readmissions 373 make in order to flesh out the program entirely. most momentous among these include: precise calculations of the base operating drg payment amount, including policies for sole community hospitals and medicare­ dependent, small rural hospitals; both the ratio and floor adjustment factors; calculations of aggregate payments for excess readmissions; and the defini­ tion of an "applicable hospital.'.s9 although a thirty-day post-discharge pe­ riod was selected as the basis for examining readmission rates, cms also mentioned its intent to ''revisit the episode length in future rulemaking as we gain more experience."90 moreover, cms listed stroke and total hip and total knee arthroplasty (replacement) readmission data as possible future measures for the inpatient quality reporting ("iqr") program.91 although this does not necessarily indicate that these quality measures would become part of the program, iqr data are reported on the hhs hospital compare website, which currently includes only the three initial measures used in the program. 92 finally, cms stated that it would consider, in future rulemak­ ing, implementation of an appeals process for hospitals unsatisfied with their calculated expected readmissions ratios93 as well as ''the benefits of publicly reporting the patient mix characteristics and the preand post­ patient-mix adjusted hcahps [(hospital consumer assessment of healthcare providers and systems)] scores of participating hospitals."94 vi. intended consequences "in the middle of difficulty lies opportunity. " -albert einstein95 while decreasing readmissions will not happen overnight, there are several. positive indications that rates may be controllable. interestingly, thirty-day rehospitalization rates during fiscal year 2004 ranged from 13.3% 42 c.f.r. pts. 412,413, 476). 89. /d. at 51,663. 90. id. at51,619. seealsoitifi'apartx. 91. cms final rule, 76 fed. reg. 51,476, 51,637 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412, 413, 476). the iqr program was designed to provide health care con­ sumers with more information regarding acute-care hospital performance in order to increase consumer choice while also giving hospitals a greater incentive to improve outcomes. hos­ pital participation in the iqr program is optional, but hospitals that do not participate re­ ceive an automatic two-percent deduction in their annual reimbursement rates. hospital inpatient quality reporting (iqr) program overview, qualitynet, http://qualitynetorg/ dcs/contentserver?c=page&pagename=qnetpublico/o2fpage%2fqnettier2&cid= 11381159 87129 (last visited feb. 3, 2012). 92. hospital compare, u.s. dep't of health & human servs., http://www.hospital compare.hhs.gov/ (last updated jan. 26, 2012) .. 93. cms final rule, 76 fed. reg. 51,476, 51,673 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412,413, 476). 94. id. at 51,660. 95. albert einstein, the ultimate quotable einstein 480 (alice calaprice ed., 2011). 374 indiana health law review [vol. 9:1 (in idaho) to 23.2% (in the district of columbia).96 the rehospitalization rate was wholly 45% higher in the five states that had the highest rates than in the five states that had the lowest rates.97 generally, the western states (with the exceptions of california and arizona) had the lowest readmission rates while the eastern and midwestern states had the highest rates.98 while regional differences in physician mentality or patient compliance may ac­ count for some of these differences, it cannot adequately explain, for exam­ ple, why lllinois had a 21.7% readmission rate while just to the north, wisconsin had only 17.00/o; or why kentucky had a 21.2% readmission rate while neighboring indiana had only a 17.7% rate.99 while these differences may be baffling, they tend to point toward an important reality: readmission rates may be, more or less, within a provider's control. perhaps, then, tex­ as (19.4% readmissionsi00 could learn something from new mexico (16.3% readmissions),101 and hospitals nationwide could learn something from idaho, with its nation-low 13.3% readmission rate.102 medp ac and cms have also indicated their conviction that readmis­ sions are a controllable problem.103 in its june 2007 report to congress/04 medp ac offered several solutions to help ease the growing readmission problem. these are discussed in part viti, above. according to a march 2010 cbo report, the hospital readmissions reduction program should save $100 million in fiscal year 2013; $300 million in 2014; $1.1 billion in 2015; $1.3 billion in 2016 and 2017; $1.4 billion in 2018; and $1.5 billion in 2019.105 all told, this provision alone could thus save at least $7.1 billion by 2019.106 since the payment reduction factor is determined as a ratio of excess readmissions compared to overall discharges, it seems that hospitals whose numbers are lagging compared to their peers might remedy this predicament by choosing to see more total patients. this would increase the denomina­ tor and thereby lower excess readmissions as a portion of overall readmis96. jencks et at., supra note 38, at 1424. 97. id at 1423. 98. ld at 1424. 99. id 100. jd 101. id 102. id 103. see cms final rule, 76 fed. reg. 51,476,51,660 (aug. 18, 2011) (to be codified at 42 c.p.r. pts. 412, 413, 476) (''many studies have demonstrated ... that hospitals and their partners have the ability to lower readmission rates."). 104. medicare payment advisory comm'n, supra note 31. 105. letter from douglas w. elmendorf: director, cong. budget office, to nancy pelosi, speaker, u.s. house of representatives, providing a final cost estimate of the direct spending and revenue effects of the patient protection and affordable care act, tbl. 5, at 4 (mar. 20, 2010), available at http://www.cbo.gov/ftpdocs/113xx/d<ic11379/amendrecon prop. pdf. 106. id 2012] consequences of penalizing hospital readmissions 375 sions.107 setting up the system to facilitate this type of competitive jockey­ ing could actually have a net positive effect on health care overall, as it would mean a larger number of medicare patients would be receiving treatment within a given month. however, for already overcrowded public hospitals, this may prove to be the proverbial straw that breaks the camel's back. 108 vll. unintended consequences even with the price floor in place, the proposed cuts would have an extremely detrimental economic impact on hospitals. john clark, m.d., j.d., medical director of clinical informatics at indiana university ("iu") health, said that member methodist hospital in indianapolis, indiana, had year-to-date admissions topping 80,000 by september of 2010.109 dr. clark pointed out that for an extensive, high-volume health system like iu health, even a one percent pay cut would mean ''millions of dollars per year'' in lost reimbursements.11° faced with bankruptcy, hospitals that cannot compete in the readmissions game will simply choose to offer fewer services, or gravitate away from treating patients with the sanctioned diagnoses. "if you can't adapt, you have to cut back services," said clark.m this is not a threat unique to indiana hospitals. hospitals across the country are feeling the economic pinch even prior to implementation of the affordable care act and the hospital readmissions reduction program. "faced with mounting debt and looming costs from the new federal health­ care law, many local governments are leaving the hospital business, shed­ ding public facilities that can be the caregiver of last resort."112 moody's investors service has predicted, "many standalone hospitals won't have the resources to invest in information technology or manage bundled payments wel1."113 what is more, "many nonprofits have bad credit ratings and in a tight credit market cannot borrow money, either."114 107. for example, if a hospital had 50 readmissions for 100 patients, they might decide to expand services and accept 100 more patients in hopes that their readmissions ratio would decrease (i.e. :from 501100 or 500.41 to 50/200 or 25%). cms makes a similar acknowledge­ ment in the final rule. cms final rule, 76 fed reg. 51,476,51,675 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412, 413, 476). cf. arnold m. epstein et al., the relationship between hospital admission rates and rehospitalizations, 365 new eng. j. men. 2287, 2294 (2011) (finding a "substantial association" between regional readmission rates and overall hospital admission rates). 108. see, e.g., levine, supra note 23; see also irifra part vii. 109. interview with john clark, medical director of clinical informatics. indiana university health, in indianapolis, ind. (sept. 17, 20 i 0). 110. id. 111. /d. 112. suzanne sataline, cosh-poor governments ditching public hospitals, wall st. j., aug. 29, 2010 (health industry section). 113. quoted in id. 114. ld. 376 indiana health law review [vol. 9:1 although the individual health care mandate,us which penalizes indi­ viduals who do not obtain health care coverage, may ease pressures on hos­ pitals that treat higher numbers of uninsured patients, due to the affordable care act's concomitant reduction in disproportionate share hospital ("dsh'') payments, 116 the effects of the mandate may be negligible on hos­ pital bottom lines. prior to the affordable care act, dsh payments were structured such that hospitals which provided care to a large number oflow­ income patients, such as those with medicaid and the uninsured, could be at least partially compensated for their efforts.117 dsh payments are calculat­ ed based on a number of factors, but they are designed to compensate hos­ pitals in proportion to· the number of uninsured and indigent patients the particular hospital serves.118 under the affordable care act, however, hhs will reduce dsh pay­ ments to hospitals by seventy-five percent beginning in fiscal year 2015.119 since readmissions tend to be higher in hospitals that treat more indi­ gents, 120 these hospitals will be hit doubly hard--losing reimbursements for readmissions while no longer. getting the dsh payments to which they are accustomed. by misplacing provider incentives, this sort of reimbursement scheme will tend to .have a disproportionate impact on the very hospitals providing the most benefit to society• s most vulnerable members. again, the impact of this. reduction may be eased by the individual health care mandate, but the mandate itself allows for individuals to pay a fee to opt out of health care coverage, 121 and violators may be difficult to track or bring to justice for a number of years because the irs and hhs must work together to reconcile their records in order to catch freeloaders. related is the issue of what types of conditions the hospital readmis­ sions reduction program includes in its payment reduction. with the in­ creasing number of specialty hospitals, those that are not in the business of treating patients with one of the three specified conditions122 will get off nearly scot-free while specialty heart hospitals which treat a disproportion115 •. patient protection and affordable care act, pub. l. no. 111-148, §§ 1501, 10106, 124 stat. i19, 242,907 (2010). 116. patient protection and affordable care act, pub. l. no. 111-148, § 2551, 124 stat 119, 312-15 (2010) (codified as amended at 42 u.s.c. § 1396r-4(f)) (reducing pay­ ments to disproportionate share hospitals). 117. christie provost peters, nat'l health policy forum, the basics: medicaid disproportionatb share hospital (dsh) payments 1 (2009), available at http://www.nhpf.org/library/the-basics/basics _dsh _ 06-1s-09.pdf. 118. id. at 3. 119. patientprotection and affordable care act, pub. l. ll1-148, § 3133(r)(1), 124 stat. 119 (2010) (codified at 42 u.s.c. § 1395ww(d)(5)(f)(i) (2010)). 120. richard cooper, hospital readmission policy flawed, action for bettbr healthcare (aug. 13, 2010), ht1p://actionforbetterhealthcare.coml'!p=1067. 121. patient protection and affordable care act, pub. l. no. 111~148, §§ 1501, 10106, 124 stat. 119, 242, 907 (2010). 122. the three conditions are heart attack, heart failure, and pneumonia. u.s. dep't of health and human servs., supra note 55. 2012] consequences of penalizing hospital readmissions 377 ately high number of patients with congestive heart failure or heart attack will stand to be unfairly penalized. or worse, these specialty hospitals may opt not to treat medicare patients at all, placing an ever-increasing burden of the sickest and oldest patients (who generally cannot afford private in­ surance) on medicare hospitals.123 a journal of hospital medicine study showed that when providers were more proactive with heart failure patient follow-up, including visit reminders, education, and regular feedback, 124 they actually tended to see higher twelve-month readmission rates ( 490/o compared to 36% for the baseline group125), but lower mortality rates (24% compared to 30% for the baseline121. a similar study published in the archives of internal medicine compared readmission rates and mortality rates in patients who were part of a multidisciplinary, post-discharge heart failure management program and patients who received the usual follow-up care.127 here, the participants in the special post-discharge program experienced "significantly decrease[ d]" hospital readmissions, but no affect on mortality rates.128 these studies expose a potential inconsistency between the desired outcome of the hospital readmissions reduction program (better long .. term health) and the likely result of the provision (immediate cost savings, but worse long-term health), indicating a misplaced incentive. it may be more appropriate to place the incentive on reducing mortality rates-which could be said to be the end goal of any medical care--rather than on read­ missions, which may or may not indicate a failure of care quality. in· one of the studies referenced above, the patients who were readmitted with less :frequency actually died sooner than those who were readmitted more readi­ ly.129 this demonstrates what could be a significant problem ·with the hrrp. viii. proposed solutions to readmissions-what is a provider to· do? there are several commonly attempted solutions to the readmission problem. dr. john clark stated130 that hospitals are trying a number of 123. levine, supra note 23. 124. alison mudge et al., the paradox of readmission: effect of a quality improve­ ment program in hospitalized patients with heart failure, 5 j. hosp. med. 148, 149 (2010). 125. id at 151. 126. id 127. femida h. gwadry-sridhar et al., a systematic review and meta-analysis of stud­ ies comparing readmission rates and mortality rates in patients with heart failure, 164 archives internalmed. 2315,2315 (2004). 128. /d. 129. mudge et al.,supranote 124, at 151. 130. interview with john clark. medical director of clinical informatics, indiana uni­ versity health, in indianapolis, ind. (sept. 17, 2010). 378 indiana health law review [vol. 9:1 methods, including telemonitoring, 131 home health care, 132 discharge fol­ low-up,133 or simple medication reconciliation.134 however, clark was hesitant to say that one method will work in all cases or that some combina­ tion of methods would not be more efficacious. so perhaps the state­ specific readmissions data cited above135 might ultimately be less portable than it appears. the problem with any of the methods mentioned by dr. clark; however, is that they are all very expensive to implement and moni­ tor. beyond the huge initial cost of an electronic device for a patient, for example, lies the latent costs of monitoring, data gathering, and data storage for scores of targeted patients, all of which would be necessary for such a program to work properly and have any hope of achieving its desired result. certain studies have seemed to bolster some of the aforementioned methods. for example, one study of philadelphia hospitals found· that re­ admissions could be reduced by forty-five percent over a twenty-four-week period by having nurses meet repeatedly with high-risk patients.136 other studies have shown the effectiveness of prompt telephone follow-up137 or hiring a ''transition coach" to ease elderly patients' passage from hospital to home.138 one model that has proven successful is the re-engineered discharge program, dubbed "project red.''139 developed at boston university medi­ cal center, project red utilizes specially trained registered nurses called "discharge advocates" to help with eleven essential components of the dis­ charge and handoff process: (1) educating patients about their condition, (2) mak­ ing appointments for clinician follow-up and post­ discharge testing, (3) discussing tests and studies with patients, (4) organizing post-discharge services, (5) confirming medication plans, ( 6) reconciling dis­ charge plans with national guidelines, (7) teaching pa­ tients to identify and deal with emergency medical situations, (8) expediting the transmission of the dis131. this entails equipping the patient with a pda or other electronic device that au­ tomatically sends health data back to the physician. 132. this typically involves a nurse or other practitioner who administers care at the patient's home. 133. a process which would include making telephone contact with the patient, espe­ cially within the crucial first few days after a discharge. 134. in other words, making sure the patient's medicines are not hindering each other's efficacy or causing other side effects due to interaction. 135. jencks et al., supra note 38, at 1424. 136. medicare payment advisory comm'n,supranote 31. 137. /d. 138. /d 139. u.s. cono. research serv., r40972, medicare hospital readmissions: issues and policy options 18 (2009). 2012] consequences of penalizing hospital readmissions charge summaries to outpatient physicians, (9) asking patients to explain their care plans to assess patient's degree of understanding, (1 0) giving patients written discharge plans at the time of discharge, and ( 11) providing telephone support shortly after discharge to reinforce the patient's discharge plan.140 379 in one study involving project red, the 370 patients enrolled in the program were one-third less likely to be readmitted to the hospital than the control group, who did not participate in the program. more than ninety percent of program participants received some form of follow-up within twenty-four hours ofleaving the hospital.141 the fact that more than half of rehospitalized patients have not seen a physician between discharge and readmission 142 seems easily remedied, but the costs of doing so for the hundreds of thousands of patients a large hospi­ tal might see per year would be staggering. the economic harm is especial­ ly great given that there is no reward under the hospital readmissions reduction program for reducing readmissions, only a penalty for not doing so.l43 another promising solution, currently underway at selected kaiser permanente hospitals in california, is the use of handheld video cameras to monitor chronically ill patients readmitted within thirty days.144 kaiser's so-called "video ethnography" program involves arming caregivers and so­ cial scientists with video cameras in order to record interviews with pa­ tients.145 the team accompanies patients home to see how medications are being managed and to interview aides and family members in order to es­ tablish a sense of how well the patient is managing his or her medication regimen. 146 they also interview pharmacists, home health providers, nurs­ es, and other physicians in an effort to get an accurate (and intimate) overall picture of how the patient is managing his or her condition.147 these videos 140. id. 141. id. 142. peter r. orszag & ezekiel j. emanuel, health care reform and cost control, 363 new eng. j. med. 601,602 (2010). 143. this predicament is discussed in more depth in janice simmons, reducing read­ missions: are quality payments a carrot or stick? healthleaders media (jan. 28, 2010), http://www.healthleadersmedia.com/page-1/qua-245642/reducing-readmissions-are­ quality-payments-a-carrot-or-stick ("with the rates of readmissions initially higher for poorer population groups, hospitals treating them will be penalized even when they try to bring these readmissions down from a high level." (quoting richard cooper, m.d.)). 144. see cheryl clark, readmissions reduction effort at kaiser involves cameras, healthleaders media (dec. 16, 2010), http://www.healthleadersmedia.com/content/qua260274/readmissions-reduction-effort-at-kaiser-involves-cameras. 145. see id. 146. see id. 147. see id. 380 indiana heal1h law review [vol. 9:1 ·are then shared and reviewed by providers at the hospital, who may then spot areas for improvement.148 kaiser found the process extremely helpful in combatting a common problem with patient self-reporting: .. [w]hat peo­ ple say they do and what they actually do are sometimes different," said kaiser's director of field studies, estee neuwirth.149 in a recent six-month period, kaiser permanente's south bay medical center in harbor city, near los angeles, was able to-reduce readmissions from 15.7% to 9%.150 a final example of a successful readmission reduction effort is the in­ tegrated· community approach to health care taken by the community of grand·junction, colorado.151 the community includes a mixture of medi­ careand medicaid-eligible individuals, ljut the dominant payer in the re­ gion is a non-profit health maintenance organization ( .. hmo"), rocky mountain health plans.152 the success of this model is largely attributed to the hmo's great influence over all providers in its network.153 examples of rocky mountain health plans' influence include "requiring providers to serve all lines of business; paying for medical review across settings to im­ prove care coordination; reinvesting profits in community priorities, such as an electronic information exchange; and providing mobile and web-based clinical support tools and generic drug samples to individual providers."154 this was complemented by"mature" health care services and practices such as "information exchange, equitable payment arrangements, shared support of the clinic for the poor, and expectations of regular exchanges of site vis­ its among members of the medical community."iss this integrated system allowed the community's dominant provider, st. mary's hospital, to achieve significantly lower rehospitalization rates and post-hospitalization mortality rates as compared with twenty comparison hospitals.156 the ma­ jor drawback with a managed care approach like grand junction's is that it seems better suited for smaller communities with only one or two major providers, but may be substantially more difficult to implement in a larger city with a more complicated provider network. iri short, while some hospitals and health systems have found ways of reducing readmissions-at least in the near term-the above case studies also reveal an important reality confronting hospitals as they seek to navi­ gate the hospital readmissions reduction program: there are as just as 148. /d. 149. quoted in id 150. clark,supranote 144. 151. marsha thorson et al., grand junction, colorado: how a community drew on its values to shape a superior health system, 29 health aff. 1678 (2010). 152. /d. 153. /d. 154. /d. at 1684. 155. /d. 156. /d 2012] consequences of penalizing hospital readmissions 381 many solutions to higher readmissions as there are apparent causes.157 even if certain populations have predictably higher readmissions than others, 158 a practical, universal solution for providers has yet to be proposed. this is where congress should step in and revise the statute, or cms should alter its interpretation of the hrrp. ix. policy implications of readmissions reduction while readmissions are decidedly undesirable, as demonstrated above, decreasing readmissions may be an elusive problem to fix. former director of the white house office of management and budget, peter orszag, ph.d., who played a prominent role in the health care overhaul that culmi­ nated in passage of the affordable care act, cited a study in the journal of the american medical association ("jama")159 to assert that early follow­ up is the key to reducing readmissions.160 but richard cooper, md, pro­ fessor of medicine and senior fellow at the leonard davis institute of health economics at the university of pennsylvania, begged to differ.161 having read the same jama report, cooper surmised that the data shows, even as early physician follow-up visits increased, the percent of readmis­ sions stayed constant. 162 in other words, according to cooper, there is no correlation between early follow-up and a reduction in hospital readmission rates. but perhaps orszag and cooper are both putting the cart before the horse. a study by medical researchers at the cleveland clinic suggests that readmissions may not even be an accurate measure of long-term patient outcomes. 163 although the conventional wisdom is that a patient being re157. it seems congress may have been aware of the nebulous nature of the problem, as the hospital readmissions reduction program includes a provision exempting "sole com­ munity hospitals" and "medicare-dependent, small rural hospitals" from its payment penal­ ties. apparently, even congress was afraid some hospitals would not be able to lower readmissions rates on their own. see 42 u.s.c. § 1395ww(q)(2)(b)(i) (2010). 158. see, e.g., mudge et al, supra note 124, at 61-67 (finding that chronic disease, depressive symptoms, and being underweight put patients at higher risk for readmission); roxana guilford-blake, medicaid status, race linked with hospital readmissions, healthleaders media, oct. 15, 2010, http://www.healthleadersmedia.com/contentjled257766/medicaid-status-race-linked-with-hospital-readmissions (finding that, after ad­ justments for other variables, being african-american raises risk of readmission by forty­ three percent and being a medicaid beneficiary raises risk of readmission by fifteen percent). 159. adrian f. hernandez et al., relationship between early physician follow-up and 30-day readmission among medicare beneficiaries hospitalized for heart failure, 303 jama 1716, 1716-22(2010). 160. peter r. orszag & ezekiel j. emanuel, health care reform and cost control, 363 new eng. j. med. 601,602 (2010). 161. richard cooper, hospital readmission policy flawed, action for betier healthcare (aug. 13, 201 0), http://actionforbetterhealthcare.com/?p= 1 067. 162. !d. 163. karen pallarito, high readmission rates may not mean worse hospital care, u.s. news & world rep. (july 14, 2010), http://health.usnews.com/health-newslfamily382 indiana health law review [vol. 9:1 admitted to the hospital within thirty days of an initial stay is a wasteful use of resources and a sign of poor-quality care generally, the study observed that, at least in the case of heart failure patients, being readmitted to the hospital after an inpatient stay may actually preserve a patient's life.164 in an analysis of newly available government data for 3857 hospitals, the re­ searchers discovered that higher readmission rates following an initial hos­ pitalization for heart failure actually correlated with a lower risk-adjusted, thirty-day death rate.165 in 2000, a survey of some nineteen readmission studies carried out over the previous ten years concluded starkly, "[m]ost readmissions seem to be caused by unmodifiable causes, and ... pending an agreed-on method to adjust for confounders, global readmission rates are not a useful indicator of quality of care."166 perhaps, then, penalizing read­ missions is not the soundest way of reducing medicare costs after all. ra­ ther, "[t]his needs to be investigated further and we need to improve it"167 in order to avoid unnecessarily decreasing care quality in the name of cost­ cutting. 168 although the hospital readmissions reduction program is a start, it is far from perfect. the major problem with the program is that it attempts to do too much in one fell swoop. the program simultaneously gathers uni­ form data among hospitals, publicizes those results, and metes out mone­ tary penalties. this may lead to an overextension of hhs resources, especially given the relatively short timeframe in which providers must comply. while gathering more data on the issue is undoubtedly a key to appro­ priately and intelligently tackling the problem of excess readmissions, the fact that hospital readmission data will become public serves to doubly pe­ nalize hospitals that take a bit longer to find a workable remedial mecha­ nism. since there are so many plausible solutions but no one-size-fits-all choice, congress or cms should consider implementing the two phases of the program at different times: first, implementing the standards and con­ ducting data-gathering, and second, penalizing for persistently high read­ mission rates. health/heart/articles/20 i 0/07 /14/high-readmission-rates-may-not-mean-worse-hospital­ care.html. 164. id 165. id. 166. jochanan benbassat & mark taragin, hospital readmissions as a measure of quality of health care: advantages and limitations, 160 archives internal med. 1074, 1074 (2000). 167. pallarito, supra note 163 (quoting denise love, executive director of the nation­ al association of health data organizations). 168. another new england journal of medicine study concluded that, with the uncer­ tain exception of heart failure patients, early follow-up and coordination of support with home caregivers did nothing or were unreliable in reducing readmissions. the study con­ cluded, "better discharge practices are necessary but not sufficient." amy e. boutwell et al., discharge planning and rates of readmissions, 362 new eng. j. med. 1244, 1244 (2010), availableathttp:/lwww.nejm.orgldoilpdfi'io.l056inejmcl00113l. 2012] consequences of penalizing hospital readmissions 383 admittedly, this approach may not save as much money as originally devised. however, one major point of suspicion in the government's logic is the cbo budget estimates on which the program relies. the cbo's budget estimates continue to increase at a near-perfect linear rate even for the four years after the floor atljustment factor has reached its peak in 2015.169 perhaps the rates are predicted to level off soon thereafter (the cbo estimate runs only through 20 19), but it is highly dubious that the amount of money saved from the program would continue to increase even after the highest reduction in reimbursements has leveled out and hospitals have presumably adapted to the new measures the affordable care act has put in place. another major weakness of the hrrp is a lack of clear goals, as demonstrated by incorrect or vague definitions of important terminology. as one example, cms has neglected to exclude unrelated readmissions in its assessment of penalties to hospitals. when confronted with concerns over the fairness of this practice and asked to exclude readmissions related to random events, cms responded, "in our view, readmissions that are truly unrelated to the hospitalization should not affect some hospitals more than others, because these readmissions should have the same probability of oc­ curring for similarly situated patients, regardless of where the patient was initially hospitalized."17° conceding that the measure is inadequate but yet will produce no prejudice due to uniform application amounts to a shirking of cms' important responsibilities. consistently employing a misguided standard does not magically transform it into a sensible one. the fact is cms was presented with a logical and viable second op­ tion in crafting its standard for potentially preventable readmissions. in 2008, several doctors and medical researchers with 3m health information systems created a method for determining whether a readmission is "poten­ tially preventable."171 using "computerized discharge abstract data,"172 the system employs a mathematical formula "based on the relationship between the reason for the original admission and the reason for the readmission. "173 doctors and researchers developed over 98,000 admission-readmission di­ agnosis pairs for the computerized system and categorized them according 169. see letter from douglas w. elmendort director, cong. budget office. to nancy pelosi, speaker. u.s. house of representatives. providing a final cost estimate of the direct spending and revenue effects of the patient protection and affordable care act 26 (mar. 20, 2010). available at ht1p://www.cbo.gov/ftpdocs/113xxldoc11379/amendreconprop.pdf. it should be noted that this data is calculated only through fiscal year 2019. 170. cms final rule, 76 fed. reg. 51,476,51,668 (aug. 18, 2011) (to be codified at 42 c.p.r. pts. 412,413, 476). 171. see generally norbert i. goldfield et al .• identifying potentially preventable re­ admissions, 30 health care fin. rev. 75, 75-91 (2008). 172. /d. at 76. 173. id. 384 indiana health law review [vol. 9:1 to whether or not they were clinically related and therefore preventable.174 clinical diagnoses from over five million hospital admissions in florida between 2004 and 2005 were used as raw data, which, after accounting for cases that could not be used (for example, cases in which the patient died), left over three million admissions as valid data points.175 the results of the study show how few readmissions are truly related to their initial diagrioses. for example, even the two medical and surgical diagnoses with the largest percentage of potentially preventable readmissions barely reached the twen­ ty percent threshold for rate of readmissions being potentially preventa­ ble.176 thus, according to this detailed study, at least eighty percent of readmissions are completely unrelated to their initial diagnoses. the 3m method recognizes the reality that any "analysis of hospital readmissions is complicated by the fact that not all readmissions are pre­ ventable, even with optimal care."177 cms, on the other hand, ignores this fact and simply resigns itself to reasoning that if a measurement applies equally across all parties involved, it must be fair. the 3m study shows that, under cms' structuring of the hrrp, hospital readmission results will be attributable solely to fortune (or lack thereof) about eighty percent of the time. this is unacceptable in a system designed to pay for performance. cms' s reason for rejecting the 3m study was that it "did not accurately specify what is related or unrelated simply by looking at the diagnoses for the admission and the readmission"178 and that the idea of excluding unre­ lated readmissions "could be subjective and prohibitively complex."179 in­ stead, cms adopted an approach that examines readmissions, the sample size for each qualifying hospital, and "[p]atient-risk factors, including age, and chronic medical conditions"180 to calculate a ''risk-standardized read­ mission ratio for each hospital."181 this risk-standardized readmission ratio is ''then multiplied by the national crude rate of readmission for the given condition to produce a risk-standardized readmission rate."182 somehow, cms reasons that this system will be less subjective and complex than the carefully crafted 3m computer program. moreover, the 3m study made clear distinctions between related, preventable readmissions and unrelated, unpreventable readmissions; whereas, as applied in the statute and regula­ tions, the term ''potentially preventable" is never even examined or truly defmed in a way that makes it a functional benchmark for hospitals to use 174. id at 78. 175. id at 79. 176. ld. at 84. 177. /dat75. 178. cms final rule, 76 fed. reg. 51,476, 51,669 (aug. 18, 2011) (to be codified at 42 c.f.r. pts. 412,413, 476). 179. /dat51,621. 180. id 181. ld. 182. id 2012] consequences of penalizjng hospital readmissions 385 in improving readmission numbers. one final weakness of the hrrp is that it provides that other "appli­ cable conditions"183 may be chosen by the secretary of hhs. this would happen through regulations rather than via statute, circumventing congress' deliberative processes and the certainty that is provided through clear rules set out in advance. x. proposed solutions while the problems with the hospital readmissions reduction pro­ gram are various, the solutions may be equally so. although each hospital is, at present, left to fend for itself against the imminent threat of possible payment reductions due to excess readmissions, struggling hospitals would do well to take note of some of the successful models in place at other hos­ pitals explained above. since there appears to be no panacea, perhaps it is best that neither congress nor hhs has yet mandated a specific readmission reduction regimen as part of its hospital readmissions reduction program. allowing hospitals to self-determine their game plans at least retains a measure of competition between providers that allows the savvy to survive and prosper. even among the two-thirds of urban u.s. hospitals operating as nonprofits, 184 most of which are tax-exempt and must therefore reinvest net income and abide by certain other governmental restrictions/85 there is a great degree of latitude in terms of operational decisionmaking. 186 still, there are certain actions congress should take to amend the aff-ordable care act, which will allow it to be more effective in easing readmissions and more realistic in incentivizing hospitals to help out in the effort. perhaps congress' principal oversight in drafting the hospital read­ missions reduction program is that readmissions are not the best measure of hospital quality.187 even so, reducing readmissions is a worthy endeavor, as it leads to cost savings and greater satisfaction among patients, payers, and providers. 188 another major policy problem with the program is that it attempts to do too much all at once. by simultaneously gathering uniform 183. 42 u.s.c. § 1395ww(q)(5)(b) (2010). 184. the remaining third is split between for-profit and government ownership. jill r. horwitz, making profits and providing care: comparing nonprofit, for-profit, and gov­ ernment hospitals, 24 realm aff. 790, 790 (2005), available at http://content. healthaf­ fairs.org/content/24/3n90.full.pdf. 185. see 26 u.s.c. § 501(c)(3) (2011) ("[n]o part of the net earnings [may] inured to the benefit of any private shareholder or individual .... "). 186. telephone interview with john clark. medical director of clinical informatics, indiana university health (feb. 2, 2011); see also 26 u.s.c. § 501(c)(3) (2011) ("[n]o part of the net earnings [may] inured to the benefit of any private shareholder or individual ... . "). 187. see supra part ix. 188. see jenny minoti, reducing hospital readmissions 9 (2008), available at http://www.academyhealth.org/fileslpublications!reducing_ hospital_ readmissions. pdf. 386 indiana health law review [vol. 9:1 data among hospitals, publicizing those results, and meting out monetary penalties, the program may handicap hospitals before they have a chance to react to the novelty of the scheme. furthermore, the wide-ranging imple­ mentation of the affordable care act will be nearly in full swing by fiscal year 2013,189 and it will undoubtedly have hospitals reeling from regulatory overload. thus, the first major change to the legislation should be to lengthen the timetable in implementing the hospital readmissions reduc­ tion program. delaying commencement of the program until 2014 or later would give congress time to revise and improve the program while allow­ ing hospitals a sufficient period to research and address their individual plans of action before putting their federal reimbursement dollars on the line. second, the terms "potentially preventable" and "excess" readmis­ sions need to be better defined in order to make them useful benchmarks for hospitals to use in improving their readmissions numbers. by the time the final rule regarding the hrrp was published in august 2011, hospitals were given barely more than a year to create and implement a successful program reducing readmissions before potentially losing millions of dollars a year in reimbursement payment reductions. section 3011 of the afforda­ ble care act required the secretary of hhs to develop and submit to con­ gress, no later than january 1, 2011, a national strategy to improve the delivery of health care services, patient health outcomes and population health.190 on march 21, 2011, the secretary submitted such a report.191 however, readmissions were mentioned only twice in the twenty-seven page report, and the only tangible measures of readmissions were the thirty­ day all-cause readmission rate and the "[p]ercentage of providers who pro­ vide a summary record of care for transitions and referrals."192 the clock is ticking for hospitals, but they have yet to receive any meaningful guidance from the government on how they will be adjudicated in their quest to re­ duce readmissions. third, congress or cms should tweak the criteria on which hospitals will be evaluated to be more objective and less capricious. the program should take into account the processes and safeguards hospitals have im­ plemented rather than looking purely at final readmissions figures and as­ sessing penalties based on outcomes that may or may not be within the hospital's control. dr. john clark of iu health said that, in his estimation, 189. see generally patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010). 190. patient protection and affordable care act, pub. l. no. 111-148, § 3011, 124 stat. 119, 378 (2010) (codified as amended at 42 u.s.c. § 241 et seq.). 191. see u.s. dep't of healtii and human ser.vs., national strategy for quality improvement ln healtii care (2011), available at http:/ /www.healthcare.gov/law/resourceslreportslnationalqualitystrategy0320 1l.pdf. 192. id. at 24. 2012] consequences of penalizing hospital readmissions 387 hospitals would prefer to be judged on quality of discharge and quality of handoff.193 "are we doing everything we can?" is the important question. "if so, then there may be an intervening cause that1s out of our hands."194 clark's point is that hospitals may be trying everything they can to ensure a patient receives quality care and appropriate and timely follow-up, but sometimes there are factors entirely outside of the provider's control that cause a patient to be readmitted unexpectedly. accidents happen, and for­ getful or obstinate patients do not always follow physician instructions to the letter, or at all. objectifying and standardizing the benchmarks for pro­ gress195 will give hospitals concrete goals instead of leaving them fishing in the dark for a solution to lower readmissions. at the very least, adoption of a more realistic readmission measure-such as 3m's approach of penalizing only readmissions that were somehow related to the initial discharge196would be of assistance to hospitals struggling to comply. this change should be a priority for cms if the hospital readmissions reduction pro­ gram is to effectuate its desired outcome within its desired timeframe. fourth, the hospital readmissions reduction program should not do away with dsh payments at this time. dsh payments are a major boon for increasing and preserving minority and impoverished access to care, as they compensate hospitals that treat indigent populations.197 therefore, eliminat­ ing dsh payments creates incentive for hospitals to alter their array of ser­ vices to those more profitable and less commonly utilized by needy patients. as hospitals seek to diversify and economize, less profitable ser­ vices, such as prevention and screening, 198 will be curtailed.199 the reason for such cutbacks is that hospitals need to be able to anticipate their cash flows in advance.200 even though screening might increase a patient's health and reduce his or her lifetime medical expenses, network hospitals do business on a yearly basis; consequently, anything that can be pushed back until the following year would tend to be overlooked. this again cre­ ates a skewed incentive. instead, the affordable care act should encourage proactive screenings and prophylactic treatments. this would likely do far more to stem rising health care costs, as patients' medical problems could be detected and treated before they ballooned into much more serious-and 193. telephone interview with john clark, medical director of clinical informatics, indiana university health (feb. 2, 2011). 194. id. 195. this could be done by simply giving a list of best practices and requiring that hospitals follow most or all of them in order to receive full medicare funding. 196. see goldfield et al., supra note 171, at 75. 197. see peters, supra note 117, at 3. 198. this would include social work services, colonoscopies, and mammograms, among many others. telephone interview with john clark, medical director of clinical informatics, indiana university health (feb. 2, 2011). 199. id. 200. id. 388 indiana health law review [vol. 9:1 more expensive--maladies. 201 xi. conclusion in summary. while the hospital readmissions reduction program is aimed at an important and costly problem. congress may have utilized too much "stick" and not enough ''carrot" to induce hospitals to adequately comply with the provision. the overbroad language and underwhelming specificity of the statute not only keep hospitals guessing as to how to best comply with its terms, the program also stands to create real problems in public health care in america: namely, a decrease in health care quality. a decrease in minority access to care, and an increase in hospital financial difficulties. with clarification of certain terms and redirection of a few in­ centives, the hospital readmissions reduction program could make a posi­ tive and notable impact on the united states' budgef02 and on public health care quality in general. 201. but see pub. l. no. 111-148, § 2713, 124 stat. 119 (2010) (codified at 42 u.s.c. § 300gg-13 (2010)) (providing that private insurers are mandated to cover screening services and preventive treatments which have been given a recommendation of "a" or "b" by the u.s. preventive services task force); uspstf a and b recommendations, u.s. preventive servs. task force, http:/tww\v .uspreventiveservicestaskforce.org/uspstf/ uspsabrecs.htm (last updated august 2010). it should be noted, however, that although in­ surers must cover such procedures, hospitals are not required or incentivized to administer them; therefore, macro-level improvements may still be slow or remain unrealized. 202. letter :from douglas w. elmendort: director, cong. budget office, to nancy pelosi, speaker, u.s. house of representatives. providing a final cost estimate of the direct spending and revenue effects of the patient protection and affordable care act 26 (mar. 20, 201 0), available at http://www.cbo.gov/ftpdocs/113xxldoc11379/ amendreconprop.pdf. charity scott charity scott, jd, mscm, is the catherine c. henson professor of law at georgia state university's college of law, with a joint appointment in the j. mack robinson college of business, institute of health administration. she is also the director of the center for law, health & society at the col­ lege of law. professor scott teaches various courses on health law and pol­ icy, bioethics, tort law, and negotiation, and has written on a range of health law and policy topics, most recently about conflict resolution in health care. she is a member of the american law institute. she was the 2010 recipient of the "heroes in healthcare" award of the healthcare ethics consortium of georgia, and the 2006 recipient of the jay healey distinguished health law teacher award, presented by the american society of law, medicine & ethics. scott currently serves on the governing council of the aba health law section, and has previously served on the aba's special committee on bioethics and the law, and as chair of the aba health law section's interest group on medical research, biotechnology, and clinical ethics. she has also served as chair of the health law section of the state bar of georgia. she received her ab from stanford university in compara­ tive literature; jd from harvard law school; and mscm from kennesaw state university. collaborating with the real world: opportunities for developing skills and values in law teaching charity scott· i. challenges in law teaching ................................................... 412 ii. opportunities to extend and improve learning in the real world ........................................................................................... 414 iii. which skills and values? ........................................................ 415 iv. clinical collaborations ......................................................... 421 v. externship collaborations ..................................................... 425 vi. working with government ...................................................... 427 a. working with federal government ........................................... 427 b. working with state government ............................................... 429 c. working with local government .............................................. 430 vii. academic interdisciplinary partnerships ............................ 432 viii. partnerships with other interdisciplinary stakeholders433 a. hospitals ................................................................................... 433 b. public health professionals ...................................................... 435 ix. real-world research collaborations with stijdents .... .436 x. field trips .................................................................................... 440 xi. bringing the real-world inside the classroom: guest speakers and skills projects .................................................. 441 xii. extracurricular activities .................................................... 443 a. activities outside of a particular class .................................... 444 b. moot court and mock trial ...................................................... 445 c. pro bono activities ................................................................... 447 xiii. collaborating with national bar and professional associations ................................................................................ 448 *charity scott, jd, mscm, catherine c. henson professor of law and director, center for law, health & society, georgia state university college of law. i am deeply indebted to all of the lfiw faculty mentioned in this article for their willingness to be teaching innovators and for the opportunity to collect and share their experiences. on the georgia state law faculty, sincerest thanks goes to professors roberta berry, lisa bliss, sylvia caley, yaniv heled, jessica gabel, randall hughes, paul lombardo, emily suski, jonathan todres, and leslie wolf for sharing with me their real-world collaborations and the skills, values, and attributes that they hoped law students would develop from them. to all of the faculty across the country who have contributed essays for a column on health law teaching that i edit for the journal of law, medicine & ethics, i am very grateful for the opportunity to learn about your teaching innovations and am inspired by your work-many of your real­ world collaborations are discussed in this article. sincerest thanks also goes to pamela brannon, faculty services librarian at georgia state law, for all her incredible research assis­ tance on this and so many other projects, and to our dean, steven kaminshine, for his con­ tinuous support of our faculty in exploring innovations in teaching at the law school. any errors are my own. 412 indiana health law review [vol. 9:2 xiv. partnerships with the local practicing bar ..•...•••...•..•...••• 449 a. one-time opportunities for students ....................................... 449 b. setting up recurring opportunities .......................................... 451 c. mentoring programs ................................................................ 451 "xy. conclusion .................................................................................. 452 i. challenges in law teaching law professors know and teach the law. law students, however, need to learn more than just the law. to be successful lawyers, they need to learn how to keep learning the law for the rest of their professional careers, which is a self-reflective skill that law professors generally do not teach in their classrooms. law students also need to learn a broad range of practical interpersonal and behavioral skills that are essential for good counseling and representation of clients. in addition, they need to internalize habits, values, and attitudes about professional work that will sustain both the qual­ ity of their work and their satisfaction with their professional lives in the future. many law professors who teach doctrinal law classes assume that their students will get an introduction to these skills and attributes of good pro­ fessional practice through a clinic or externship experience in law school, or else that their students will just figure it out as they go along in their ca­ reers, as perhaps the law professors themselves did after graduation. tradi­ tionally, classroom law professors1 have focused on improving students' knowledge of the law, their cognitive skills in analyzing its application to new contexts, their ability to think quickly and argue orally in the socratic classroom, and to a lesser extent, their skills in writing. despite decades of calls for legal education reform, 2 classroom law professors have not thought 1. professors who teach doctrinal courses--as opposed to clinic-based courses-have been variously called "doctrinal," "traditional," "classroom," "podium," "classic," or "non­ clinical" professors. i am using the phrase "classroom professor" in this article to refer to professors who predominantly teach doctrinal law courses and whose pedagogical focus is largely on developing knowledge and analytical skills in standard law school domains (e.g., traditional first-year courses, subjects covered in bar exams, and upper-level electives in mainstay legal subjects). 2. twenty years ago, the american bar association issued an in-depth report that described a vision of the lawyering skills and professional values that new lawyers should seek to acquire and called on law schools to help develop them. am. bar ass'n, section of legal education and admissions to tiffi bar, legal education and professional development-an educational curriculum; report of tiffi task force on law schools and tiffi profession: narrowing tiffi gap (1992) [hereinafter maccrate report after the chairperson of the task force, robert macerate). a more recent yet simi­ lar report was issued by the carnegie foundation for the advancement of teaching under its preparation for the professions series. william m. sullivan et al., educating lawyers: preparation for tiffi profession of law (2007), available at http:/ /www.carnegiefoundation.org/sites/default/files/elibrary!educatinglawyers _summary. 2012] developing skills and values in law teaching 413 it their responsibility to offer opportunities for their students to learn the wide set of skills, values, and attributes that good lawyers exemplify. as a result, law students have mostly learned how to be and think like law students. they have not learned how to be, think, and act like lawyers. 3 even if this state of affairs in legal education worked satisfactorily for· law school graduates in the past, it is not working well now in times of eco­ nomic downturn, and it will not work well for the future given the changing global environment oflaw practice. increasingly, clients are refusing to pay for young associates to learn these skills and values on the job, and employ­ ers are deciding to hire only lateral attorneys who have managed to learn them at someone else's billable expense.4 pdf [hereinafter carnegie report]. a project of the clinical legal education association came to similar conclusions and provides a comprehensive set of recommendations for im­ proving legal education. roy s1uckey et al., best practices for legal education: a vision and a road map (2007) [hereinafter best practices report]. see also erwin chemerinsky, why not clinical education?, 16 clinical l. rev. 35, 37 (2009) (citing pre­ vious calls for legal education refonn dating back to 1921 and observing that the "carnegie commission report, for all the attention that it has received, is just the latest in a series that makes the same basic points about the need for more training in practical skills and more experiential learning"); john lande & jean r. sternlight, the potential contribution of adr to an integrated curriculum: preparing law students for real world lawyering, 25 omo st. j. on disp. re~ol. 247, 256-59 (2010) (discussing curricular refonn proposals to en-. hance the teaching oflawyering skills dating back to 1914); amy deen westbrook, learning from wall street: a venture in transactional legal education, 27 qu!nnipiac l. rev. 227, 244-62 (2009) (discussing calls for refonn dating back to the time of christopher columbus langdell, dean of harvard law school in the late 1880s and the founder of the now­ traditional socratic, appellate case-method approach oflegal education). 3. the carnegie report identified two major limitations in legal education: (1) most law schools give only casual attention to teaching students how to use legal thinking in the complexity of actual law practice. "unlike other professional education, most notably medi­ cal school, legal education typically pays relatively little attention to direct training in pro­ fessional practice. the result is to prolong and reinforce the habits of thinking like a student rather than an apprentice practitioner, thus conveying the impression that lawyers are more like competitive scholars than attorneys engaged with the problems of clients"; and (2) "law schools failo to complement the focus on skill in legal analysis with effective support for developing ethical and social dimensions of the profession. students need opportunities to learn about, reflect on, and practice the responsibilities of legal professionals. despite pro­ gress in making legal ethics a part of the curriculum, law schools rarely pay consistent atten­ tion to the social and cultural contexts of legal institutions and the varied forms of legal practice." carnegie report, supra note 2, at 188. see also david segal, what they don't teach law students: lawyering, n.y. times, nov. 11, 2011, at ai (first-year associate tak­ ing four-month intensive training on cotparate law at law finn observed: ''what they taught us at this law finn is how to be a lawyer .... what they taught us at law school is how to graduate from law school."). 4. see, e.g., jeanne graham, new associate hires drop 13 percent, tex. law., oct. 31, 2011, at i; annie johnson, nashville firms hiring more experienced lawyers over recent grads, nashville bus. j., may 20, 2011, available at http://www.bizjoumals.com/ nashville/print-edition/2011/05/20/lawyers-needed-for-nashville-firms.html?page==alll; · ash­ by jones & joseph palazzolo, what's a first-year lawyer worth?, wall st. j., oct. i7, 2011, at bl (answering title question in subtitle, ''not much, say a growing nrimber of corporate clients who refuse to pay"); steven lichtman, pro/con: to go to law school or not?: the rise of "dr. no", 34 pa. law. 18 (jan./feb. 2012); joe palazzolo, first-year associates: are they worth it?, wall st. j. l. bloo (oct. 17, 2011, 9:59 am), http://blogs. wsj.com/law/20 11/1 0/17/first-year-associates-are-they-worth-it/. a 2010 survey 414 indiana health law review [vol. 9:2 ii. opportunities to extend and improve learning in the real world the good news is that classroom law professors can help their students learn the skills, values, and attributes of good professional practice by sup· plementing what they already are teaching well with opportunities to learn the law in real-world contexts. classroom professors do not need to be­ come clinical professors or start teaching lawyering skills courses. instead, they can collaborate with clinical professors, practicing lawyers, and other professionals outside their classrooms in settings that relate to their doctri­ nal fields. such collaborations can effectively draw on others' expertise and skills to extend and deepen their students' learning and thereby better prepare them for real-world practice. "learning in context" is the most effective way to engender long­ lasting learning and genuine understanding.5 the collaborations discussed in this article offer real-world contexts that promote this deeper engagement in learning. in addition, they allow the integration of the three domains (or "apprenticeships") of professional competency and identity that the carne­ gie report advocated be integrated in legal education: (1) knowledge (in­ cluding cognitive and analytical skills); (2) interactive behavioral skills (including problem-solving, client-oriented, and communication skills); and (3) professional values and ethics.6 these three domains reflect what com­ petent lawyers should know and how they think, what they should be ~;tble to do, and how they should act as professionals. real-world collaborations help to integrate the three carnegie apprenticeships in one course, rather by the american lawyer reported that 47% of law-firm respondents said that clients had refused to pay for work by firstor second-year associates. amlaw 's law firm leaders survey finds recession-prompted internal changes are here to stay and may be the rea­ son for biglaw optimism, law librarian bldg (dec. 7, 2010), http://lawprofessors.type pad. com/law _librarian_ blog/201 0/12/amlaws-law-firm-leaders-survey-finds-recession­ prompted-changes.html. see generally robert l rhee, on legal education and reform.' one view formed from diverse perspectives, 70 md. l. rev. 310 (2011) (describing the dynamically changing landscape of the legal profession and the disconnection between law practice and legal education). 5. the best practices report emphasizes the importance of context-based education: "context helps students understand what they are learning, provides anchor points so they can recall what they learn, and shows them how to transfer what they learn in the classroom to lawyers' tasks in practice. adult learning theory suggests that our students will learn best if they have context for what they are learning." best practices report, supra note 2, at 14l-42 (quoting deborah maranville, infosing passion and context into the traditional law curriculum through experiential learning, 51 j. legal enuc. 51 (200 1) (citations and internal quotation marks omitted)). see generally id. at 141-57. 6. carnegie report, supra note 2, at 27-28, 145-47. the carnegie report identi­ fied three "apprenticeships" in legal education: (1) "the first apprenticeship, which we call intellectual or cognitive, focuses the student on the knowledge and way of thinking of the profession." (2) "the students' second apprenticeship is to the forms of expert practice shared by competent practitioners." (3) "the third apprenticeship, which we call the appren­ ticeship of identity and purpose, introduces students to the purposes and attitudes that are guided by the values for which the professional community is responsible." id. at 28. 2012] developing skills and values in law teachjng 415 than keep them siloed in different courses.7 this article describes a broad range of teaching innovations and op­ portunities that classroom law professors can take advantage of in their own backyards. they are examples of real-world engagement by faculty across the country. while they are drawn largely from health law settings-which is my doctrinal area of expertise8 and is relevant to this article's placement in a symposium on health law teaching-these examples are nonetheless readily translatable to any other field of law. all it takes is a bit of creative thinking as to what opportunities might exist in your own doctrinal field and in your own locale. if you are used to teaching in a predominately doctrinal classroom, adopting one or more of these innovations may take some extra time and effort on your part to establish those collaborative connections, though the amount of time depends on how much you want to undertake. these teach­ ing innovations vary in the intensity of faculty engagement, and they can take anywhere from an hour to a day to a week or even a year or more to implement. by exploring a broad range of innovative options, this article is intended to serve as inspiration to consider experimenting in your own clas­ ses in large or small ways, depending on your interests, time, and resources as well as on the skills and values that you want your students to develop. ill. which skills and values? the skills, values, and attributes of professional practice that this arti­ cle explores through real-world collaborations with law professors are those that the macerate, carnegie, and best practices reports9 and other calls for reform have discussed as being under-developed in law school. while there is general consensus that law schools do a good job educating law students in legal knowledge and cognitive analytical skills, these reports and others have called on law schools to increase education in the other lawyering 7. the carnegie report called for an integrative, rather than additive, strategy for developing competency in the three apprenticeships. the traditional approach to legal edu­ cation reform has been additive-reforming the curriculum by adding new courses and leav­ ing the existing ones unchanged. by contrast, "[t]he core insight behind the integrative strategy is that effective educational efforts must be understood in holistic rather than atom­ istic terms. for law schools, this means that, far from remaining uncontaminated by each other, each aspect of the legal apprenticeship-the cognitive, the practical, and the ethical­ social-takes on part of its character from the kind of relationship it has with the others." !d. at 191. 8. i began teaching health law courses at georgia state law in 1987. my experience as director of our center for law, health & society since 2004 gives me one perch from which to view the teaching innovations across our georgia state law faculty, many of which are described here. my experience as editor of a column on teaching health law since 2007 for the journal of law, medicine & ethics is a second perch from which i have learned about teaching innovations in health law throughout the country, many of which are also described here. 9. see supra note 2. 416 indiana health law review [vol. 9:2 skills and professional values and attributes. while not all-inclusive, the lawyering skills and professional values that are generally agreed-upon as important for lawyer competency and effectiveness are listed in figure 1.10 10. the traits in column l and 2 of figure 1 are taken from the macerate report, and they continue to be considered important lawyering skills and professional values in the carnegie and best practices reports. column 3 identifies underlying skills and characteris­ tics that support or are needed for developing the skills and values in the first two columns. they are attributes for success in any employment setting, and they reflect personality traits and qualities that many employers, including legal employers, are increasingly looking and even testing for in new employees. see infra note 16 and accompanying text. recent schol­ arship has attempted to identify and measure key skills and values for effective lawyering practice. see marjorie m. shultz & sheldon zedeck, predicting lawyer effectiveness: broadening the basis for law &hool admissions decisions, 36 law & soc. inquiry 620 (20 11) (identifying twenty-six factors important to lawyer effectiveness and seven personali­ ty traits predictive of work performance). the twenty-six factors are, by category: (i) intel­ lectual and cognitive--analysis and reasoning; creativity/innovation; problem solving; practical judgment; (2) research and information gathering-researching the law; fact find­ ing; questioning and interviewing; (3) communications-influencing and advocating; writ­ ing; speaking; listening; (4) planning and organizing-strategic planning, organizing and managing one's own work; organizing and managing others; conflict resolution­ negotiation skills; ability to see world through the eyes of others; (5) client and business development-networking and business development; advising clients; (6) working with others-developing relationships within the legal profession; evaluation, development, and mentoring; and (7) character-passion and engagement; diligence; integrity/honesty; stress management; community involvement and service; self-development. id at 630 (table 1) and 651-53 (table 8). the seven personality traits (based on the hogan personality invento­ ry and correlated with the "big five" personality factors) have been used to predict work performance. the seven traits are: adjustment, ambition (leadership, achievement-oriented), sociability, interpersonal sensitivity, prudence, inquisitiveness, and enjoyment of education for own its own sake. id at 634 (table 2). for information on the hogan personality inven­ tory in the context of the lawyer personality, see jeff foster et al., understanding lawyers: why we do the things we do (2010), available at http://www .hoganassessments.cornlsites/defaultlfiles!lawyer _personality _l2.l_l.pdf. for information about the "big five" personality factors (openness, conscientiousness, extraver­ sion, agreeableness, and emotional stability) and testing, see the big five personality test, http://www.outofservice.com/bigfive/info/ (last visited june 6, 2012). see also best practices report, supra note 2, at 65-91 (identifying the attributes of effective, responsi­ ble lawyers as (1) self-reflection and life-long learning skills; (2) intellectual and analytical skills, including practical judgment and self-efficacy; (3) core knowledge of the law; (4) core understanding of the law; ( 5) professional skills, including communication. ability to resolve ethical dilemmas, client relationship management, advocacy, self-awareness, workload man­ agement, and ability to work in team; and (6) professionalism, including integrity, commit­ ment to justice, respect for rule oflaw, honor, integrity, fair play, truthfulness, candor, ability to deal effectively and sensitively with diverse people, and ability to nurture quality of life); stephen gerst & gerald hess, professional skills and values in legal education, 43 val. u. l. rev. 513, 520-30 (2009) (discussing surveys oflawyers to identify essential lawyering skills and the authors' choice of thirteen specific professional skills to concentrate on in a new course on general practice skills, and emphasizing professional values in the new course, including integrity and honesty, reliability, competence, treating people with respect, creativity and innovation, tolerance, patience, and empathy); janet weinstein & linda mor­ ton, interdisciplinary problem solving courses as a context for nurturing intrinsic values, 13 clinical l. rev, 839, 843 (2007) (discussing the skills, values, and attitudes that the authors hav:e designed their interdisciplinary educational collaborations to promote, which are, by category: (1) expanding approaches to problem solving-broad vision, considera­ tions of justice, systems thinking, and creative thinking; (2) working with others-consensus 2012] developing skills and values in law teaching 417 figure 1. lawyering skills, professional values, and other attributes that can be developed through real-world collaborations and that are de­ sired by organizations, agencies, and firms that employ lawyers. practical lawyering v aloes, ethics, and interpersonal and behavsldlls11 other professional ioral sldlls, habits, attitudes, qualities and and frames of mind needed traits12 for or supporting the practical lawyering sldlls and professional values in the other two columns13 • problem solving • providing com• creativity • legal analysis petent represen• practical judgment and reasoning tation • listening and observing • legal research • striving to • questioning (asking the • factual investipromote jusright questions; appreciagation commutice, fairness, tive inquiry) nication (oral and morality • strategic thinkand written) • striving to iminglplanning • counseling prove the pro• empathy (ability to see • negotiation fession world through others' • ability to en• professional eyes) gage in litigation self• building trust and relaprocesses development tionships • ability to en• networking gage in alterna• mentoring and developtive dispute ment of others resolution pro• self-awareness and selfbuilding, teamwork. respect for others, respect for differences, and communication skills; (3) focusing on community-compassion, serving others, and unselfishness; ( 4) developing sense of self-building self-esteem and self-confidence, self-governance and autonomy); lande & sternlight, supra note 2, at 262-63 (discussing how integrating adr across the legal curriculum could help law students develop the skills and values need to be effective in important lawyer roles, including the roles of interviewer, counselor, process selection advi­ sor, negotiator, advocate, and transactional problem-solver). see also the problem-solving skills, attitudes, values, and methods discussed by morton, infra notes 60-63. 11. this list of practical lawyering skills is adapted from the ten "fundamental lawyer­ ing skills" identified in the macerate report, supra note 2, at 141-207. 12. this list of values is adapted from the four ''fundamental values of the profession" identified in the macerate report, supra note 2, at 207-21. 13. many of the attributes in this column are drawn from marjorie m. shultz & shel­ don zedeck, predicting lawyer effectiveness: broadening the &uis for law school admis­ sion decisions, 36 law & soc. inquiry 620, 624-25 (2011) (discussing twenty-six factors identified as important to lawyering effectiveness and seven personality and behavioral fac­ tors predictive of workplace performance effectiveness). a number of these lawyering ef­ fectiveness factors identified by shultz and zedeck are also covered in the other two columns. see supra note 10 and accompanying text for other sources and references regard­ ing the underlying skills, habits, and attitudes listed in this column. 418 indiana health law review [vol. 9:2 cesses reflection • organization • self-motivation and selfand managedevelopment ment of legal • stress management and work ability to take care of self • recognizing and • emotional stability resolving ethical • resiliency dilemmas • passion and engagement • diligence, conscientiousness • integrity and honesty • flexibility and adaptability • collaboration and teamwork • open-mindedness • curiosity • a voidance of premature judgments • independence • tolerance/respect for differences • ability to cope with conflict • self-confidence • initiative, leadership_ for each example of real-world collaboration discussed in this article, i attempt to identify some of the key skills, values, and attributes that can be promoted by adopting it. when our health law facu1ty at georgia state convened a group of highly respected health law attorneys in atlanta in the fall of 2011 to advise us as we considered revisions to our health law curriculum, the attorneys uniformly and repeatedly encouraged us to offer more skills opportunities. they echoed in concrete terms what the carnegie report and other reform proposals have been advocating. for example, with respect to developing communication skills, they said: "we want to hire attorneys who can talk effectively to different kinds of people. this includes our staff, our clients, other attorneys, board members, hospital administrators, various kinds of clinical practitioners such as doctors, nurses, and emergency room techni­ cians, and anyone else who works with the organizations we represent." they also wanted attorneys who understand how to communicate in differ­ ent forums-who can facilitate meetings, be as effective in informal con­ versations as in formal powerpoint presentations, negotiate comfortably, as well as conduct the formal oral advocacy that law schools have traditionally 2012] developing skills and valves in law teaching 419 focused on. above all, they wanted attorneys who can solve real-world problems, who can manage their time and their projects, and who have the interpersonal skills to collaborate, work in teams, and cope with conflict. these attorneys also emphasized that in their hiring decisions, they are looking for other attributes, values, and traits of effective lawyers. for ex­ ample, do the candidates have a strong work ethic? do they have both ini­ tiative and follow-through ("can they take a project from start to finish")? do they have independence and maturity ("or do they need their hands held")? do they understand the professional environment ("do they know how to dress and behave")? as one attorney commented, "people are hired for their technical traits. they are fired for their personal traits." law pro­ fessors should realize that they are helping better prepare their students for employment and practice when they do not limit their students' educational exposure to technical (doctrinal) knowledge and analytical skills, and give them in addition broader opportunities to develop other essential attributes of being a good professional. moreover, for these attorneys, knowledge about the industry regulated by laws was as important for students to gain as doctrinal knowledge of the laws themselves. in this article i call this kind of knowledge "domain knowledge" (as opposed to doctrinal knowledge) or "cultural literacy": it is familiarity with the range of key players and stakeholders in a field or in­ dustry; a sense of the practical business, financial, social, political, and ethi­ cal challenges they face; and an understanding of the professional cultures they operate in-in short, knowing "how the system works" in the field or industry. for example, professor randall hughes, a faculty fellow at georgia state law and a distinguished atlanta attorney from private prac­ tice who has taught our health care business regulation course for a number of years, has long felt strongly that without such knowledge about the health care industry itself, students could never really appreciate what the health care laws and regulations were concerned with or how they applied to different transactions.14 the real-world collaborations described in this 14. randall h. hughes has been an adjunct professor and is currently a faculty fel­ low with our health law program. he believed that it is so important for students to have this kind of domain knowledge (understanding of the health care industry, how it is financed, and how health care is delivered) that he encouraged the creation of our joint-degree programs with the institute of health administration at georgia state's j. mack robinson college of business. we now offer opportunities for joint jd-msha (master of science in health ad­ ministration) and jd-mba-mha (master of business administration/master of health admin­ istration) degrees. as the well-respected former head of a health law practice group at powell goldstein (now of counsel with bryan cave, llp), hughes provides real-world context for the many of the topics in his regulation course through his own extensive experi­ ence, guest speakers, and technological innovations. see hughes creates a virtual law office setting for health law students, ga. st. univ. coll. law (feb. 22, 2011), http:l!law.gsu.edu/clhs/6586.html. hughes also is an extraordinary role model for our stu­ dents in pro bono service to the community. see hughes drafted as 2011 atlanta falcons community quarterback, ga. st. univ. coll. law (dec. 5, 2011), http://law.gsu.edu/ . 420 indiana healrn law review [vol. 9:2 article provide direcf opportunities for students to gain such domain knowledge and a ''big picture" understanding of how the health care indus­ try works. who the players and stakeholders· are. how they are organized and interact. and how their professional cultures influence behavior. such cultural literacy is essential for effective client counseling and representa­ tion.15 what our focus group of attorneys said about what they were looking for in hiring reflects national trends. increasingly. law firms are going be­ yond reviewing a transcript. resume, and writing samples and are using per­ sonality testing and other behavioral interviewing techniques before deciding whom to hire. 16 in recruiting, law firms across the country are looking for such attributes as intellectual curiosity, initiative, resiliency, ability to work in a team, communication and interpersonal skills, leader­ ship, and maturity.17 clbs/7456.html; hughes receives h. sol clark award, ga. st. univ. coll. law (feb. 11, 2011), http://law.gsu.edu/clhs/6598.html; lifetime commitmen( to legal services award honors hughes, ga. st. univ. coll. law (jan. 27, 2011), http://law.gsu.edu/clhs/ 6622.html. hughes has also written about teaching as an adjunct faculty member. see paul frisch, randall l. hughes, & joan b. killgore, the perspectives of three adjunct profes­ sors, 36 j.l. men. & ennes 179 (2008). fully exploring how to develop real-world collabo­ rations with professional practitioners like hughes through hiring adjunct faculty, faculty fellows, professors of the practice, and resident practitioners is unfortunately beyond the scope of this article. 15. see stephen j. friedman, why can't law students be more like lawyers?, 37 u. tol. l. rev. 81, 91 (2005) ("a lawyer cannot be successful or of real use to clients if his or her understanding extends only to basic concepts, even if it is those concepts that are at stake in a case on which he or she is working. it is only when a young lawyer has a broad under­ standing of the way the individual or corporate tax system works, or of the regulation of the issuance of securities, or of international trade, that he or she really begins to think like a lawyer."). 16. see, e.g., vivia chen, mckenna long's recruiting couch, careerist (jan. 25, 2011, 6:44am) (discussing law firm's use of psychological test as part of job callbacks), http://thecareerist.typepad.com/thecareerist/20 11/0 1/should-firms-use-psyche-test-in­ hiring.html; katy hopkins, law firms dig deeper in new interviews, u.s. news & world report (may 17, 2011), http://www.usnews.com/educationlbest-graduate-schools/top-law­ schools/articles/2011/05/17 /law-firms-dig-deeper-in-new-interviews (discussing interactive, probing interviews that give a law firm "a chance to evaluate a student's analytical and communication skills ... as well as their abilities to listen artd work as part of a team"); gina passarella, in recruiting, behavioral interviewing gains momentum, 242 legal intelligencer 1, aug. 23, 2010 (discussing increasing use of behavioral interviewing tech­ niques to assess character traits such as resiliency. ability to cope with adversity, and flexi­ bility to deal with new situations); larry richard, herding cats: the lawyer personality revealed, report to legal management, aug. 2002, available at http://www.managing partnerforum.org/tasks/sites!mpf7assets/image/mpf%20-o/o20website%20%20article%20-%20herding%20catso/o20-o/o20richards1.pdf(discussing the use in law firms and corporate law departments of the caliper profile for making hiring decisions as well as for coaching, development, and leadership training; test measures such traits as skep­ ticism. urgency, sociability, resilience, and autonomy). 17. vivia chen, pau~ weiss wants fun intellectuals, careerist (sept. 26,2011, 1:41 pm), http:l/thecareerist.typepad.com/thecareerist/2011/09/paul-weiss-hiring-partner.html ("we look for someone who's smart, personable, and interesting-someone who has intel­ lectual curiosity that goes beyond the mundane. [w]e also look for nonlegal achievement­ what their greater interests are, leadership roles they've had. j; vivia chen, kramer levin's 2012] developing skills and values in law teaching 421 this article progresses from the most timeand resource-intensive re­ al-world collaborations to those that would not take much more than a phone call and a few hours of your time. for each teaching innovation, the article highlights and discusses some of the core skills, values, and qualities that can be cultivated by it, as well as how relevant domain knowledge is conveyed by it. whenever adopting a new teaching strategy, we professors should be clear about which core competencies we are hoping to foster. being as transparent as possible with our students about what we hope they learn helps them to learn it. iv. clinical collaborations our law school is relatively young, and we have only two clinics: in tax law and health law. 18 with resources going to other educational en­ deavors in our law school's early years, it fell to the classroom faculty in these two doctrinal fields to initiate these clinics. setting up a clinic is the most timeand resource-intensive undertaking discussed in this article for creating opportunities to develop students' skills and professional values. starting in the early 1990s, i worked with our then-alumna, now­ professor sylvia caley to find community partners who might be willing to collaborate in providing legal services to low-income patients at a hospital that would allow lawyers set up an office on its premises. the idea that hospitals and lawyers might work together to improve the health of low­ income communities was a novelty at the time. it met with considerable resistance from health care providers who suspected we would instead be trolling for potential malpractice plaintiffs. by 2004, after a series of unsuccessful attempts and proposals, caley litmus test-are you presentable to clients?, careerist (july 15, 2011, 2:23 pm), http:/ /thecareerist.typepad.com/thecareerist/20 11/071kramer-levin-hp.html (observing that the finn's practice "requires someone who's flexible. you need to be self-directed here and take control of your career at an early stage, ... [we're looking for] [i}nterest that goes be­ yond oneself-like doing tutoring, something that involves the community. something that shows that the person is thoughtful and well-rounded."); vivia chen, baker botts hunts for 1-ls, careerist (jan. 18, 2011, 6:20 am), http://thecareerist.typepad.com/thecareerist/ 20ll/ollqa-baker-botts-hp.html ("the interview is tied to our associate attributes model. we expect people to be well-spoken, tactful, and able to communicate with different audi­ ences."); vivia chen, vinson & elkins hiring partner spills the beans, careerist (june 3, 2010, 1:31 pm), http://thecareerist.typepad.com/thecareerist/201 0/06/vinson-elkins-hiring­ partner-spills-the-beans.html ("the folks who do best are self-starters, they tend to be a bit entrepreneurial."); passarella, supra note 16 ("morgan lewis is looking for team orientation, client service potential and communication and interpersonal skills .... [w]e've taken to heart the comments that we've received from clients that they want a certain level of maturi­ ty and experience from people that are doing their work."). 18. both are poverty law clinics representing low-income clients in their respective fields. for infonnation about the help legal services clinic discussed here, see help le­ gal services clinic, ga. st. univ. colt. law, http://law.gsu.edu/helpcliniclindex.html (last visited may 4, 2012). for infonnation about the low-income taxpayer clinic, see low­ income taxpayer clinic, ga. st. univ. coll. law, http://law.gsu.edu!taxclinic/index.html (last visited may 4, 2012). 422 indiana health law revffiw [vol. 9:2 and i finally found a hospital whose legal counsel was willing to adopt this project on a pilot basis. the result was the health law partnership (help), which is a community collaboration among our law school, the atlanta le­ gal aid society, and children's healthcare of atlanta.19 while it was a sig­ nificant accomplishment after so many years of effort/0 setting up help offices with legal aid attorneys at children's hospitals was just the first step in reaching our long-term educational goals. help would be the platform from which we would be able to offer interdisciplinary education in real­ world settings for law students. still to be worked out was creating the help legal services clinic at the law school next steps included gaining law school administration and faculty ap­ proval for a new educational clinic, securing the initial funding for it, over­ seeing the hiring of its clinical faculty and other foundational matters, and negotiating its long-term funding at the university. the first law students enrolled in the help legal services clinic in 2007. since then, our excep­ tionally talented and dedicated help clinic faculti1 have significantly ex­ panded interdisciplinary educational opportunities for our law students. 19. the health law partnership (help) seeks to reduce health inequities in the atlan­ ta community by addressing some of the toughest underlying root causes of health dispari­ ties-the social, economic, and environmental determinants of health. by working in teams with health professionals, help attorneys and students can address a wide variety challeng­ es-such as substandard housing conditions, employment problems, lack of access to insur­ ance or appropriate educational resources, and family instability-that can adversely impact the health and well-being of low-income children. only families at 200% of the federal poverty level and under are eligible to receive help's services. see help health law par1nership, http://www.healthlawpartnership.orgl (last visited may 4, 2012). 20. dale hetzler, jd, mscm, was the innovative and invaluable general counsel and vice president for legal affairs at children's healthcare who was responsible for persuad­ ing children's healthcare to create the project at the hospitals in the first place. steve gottlieb, jd, executive director of the atlanta legal aid society (alas), had the foresight and vision to appreciate how establishing legal aid offices on hospital premises could im­ prove access to legal services for the low-income communities alas serves. robert pet­ tignano, md, faap, fccm, mba, is help's "medical champion" and has worked tirelessly and effectively to maintain help's presence at children's healthcare. dr. pet­ tignano is director of medical affairs, children's healthcare of atlanta at hughes spalding, and associate professor of pediatrics at emory university school of medicine. 21. the help clinic faculty now includes lisa bliss, associate clinical professor and co-director of the help legal services clinic; sylvia caley, help director, associate clinical professor, and co-director of the help legal services clinic; and emily suski, clinical supervising attorney. while i served as the initial help clinic director for five years for continuity and accreditation purposes, i never intended to teach in the clinic my­ self; i had my teaching hands full with more traditional classroom courses. i also knew we could find much more talented faculty who understood clinical education and wanted to engage with it full time. instead, my role was limited to establishing a foundation for launching the clinic through fund-raising and organization; hiring the initial faculty; over­ seeing its first years; and ultimately engaging in research and scholarship about the project. my overall involvement has always been aimed at facilitating this opportunity for our stu­ dents to learn the kinds oflawyering skills and values that come with clinical education, and to do so in a fully interdisciplinary setting that provided them with opportunities to collabo­ rate closely with health professionals. 2012) developing skills and values in law teaching 423 the clinic classes and representation of clients now incorporate graduate students in social wor~2 and public health23 from georgia state university, medical students from morehouse school of medicine,24 and medical resi­ dents from emory school ofmedicine?5 fortunately today, law faculty who may be interested in setting up this kind of real-world collaboration do not have to start from scratch. interdis­ ciplinary law and health-related partnerships are gaining momentum across the country.26 more than forty law schools have set up interdisciplinary clinics, courses, and externships that engage legal and health professionals in educational and service collaborations. 27 there are now plenty of models and resources to enable any law school to undertake this kind of innovation. but why go to all this effort in the first place? what do students get from learning to solve clients' problems in this interdisciplinary context? certainly they are gaining doctrinal knowledge (poverty law) and domain knowledge (about the health care system and low-income communities), as well as acquiring practical lawyering skills (such as interviewing, counsel­ ing, negotiation, and advocacy). they are also given the opportunity to de­ velop the skills of self-refection, self-critique, and self-awareness through reflective journaling and mentoring by the clinical faculty. equally important, the students are learning the values of respect for other professional perspectives and differences, the benefits of collaborative lawyering and building rapport and trust with clients, and the need to col22. help clinic adds social work student to interdisciplinary collaboration, ga. st. univ. coll. law (sept. 26, 2011), http://law.gsu.edulclhs/7652.html. 23. new mph student in help clinic focuses on health disparities, ga. st. univ. coll. law (oct. 6, 2011), http://law.gsu.edulclhs/7430.html?id=570. 24. see, e.g., paul mello, medicine meets law: a medical student's reflections, ga. st. univ. coll. law (mar. 22, 2011), http://1aw.gsu.edulclhs/6566.html?id=543; a medical student's reflections on working with law students, ga. st. univ. coll. law (dec. 1, 2009) http://law.gsu.edulclhs/6675.html?id=452. 25. a deep commitment to working collaboratively across the legal and health profes~ sions is a hallmark of all of help's partners. see, e.g., help holds annual retreat, ga. st. univ. coll. law (mar. 30, 2011), http://law.gsu.edulclhs/6551.html?id=550. 26. since 1993, boston medical center has provided leadership to promote the crea­ tion of medical-legal partnerships (mlps) across the country, establishing in 2009 a national center for medical-legal partnership. see history, nat'l ctr. for medical-legal p'shjp, http://www.medical-legalpartnership.orglabout-uslhistory (last visited may 13, 2012). in september 2011, a senate bill was introduced to provide funding for model mlp projects. see mlp for health act, nat'l ctr. for medical-legal p'ship, http://www.medical~ 1egalpartnership.orglnational-center/health-act (last visited may 13, 2012). an annual na­ tional conference ofmlps as well as abundant resources on the national center's web site offer tools, advice, and information for getting a project developed in a new community. see build a partnership, nat'l ctr. for medical-legal p'ship, http://www.medical­ legalpartnership;orglstart-a-partnershiplbuild-a-partnership (last visited may 13, 2012). see also elizabeth tobin tyler et al., poverty, health and law: readings and cases for medical-legal partnership (20 11 ). 27. see law schools, nat'l ctr. for medical-legal p'ship, http://www.medical­ legalpartnership.orglmlp-network!law-schools#law _schools_ and_ mlp (last visited may 13, 2012). 424 indiana health law review [vol. 9:2 laborate with other professionals to better advance client interests. 28 suc­ cessful representation of clients through interdisciplinary teamwork with other graduate and professional students develops our law students' self­ confidence and independence as well as their professional judgment and instincts. working outside the law school with the clients and help's community partners (health care providers and legal aid attorneys) also gives students a sense of their broader community, which can foster their appreciation of the role of law and lawyers in promoting justice generauy and health equity in particular. this exposure can be key to promoting a professional commitment to providing pro bono services and strengthening their communities after graduation, even while their careers may diverge in very different directions. "working with the help legal services clinic has been the most pro­ found experience that i have had in law school," wrote a recent law student. "i came into the clinic with a highly theoretical idea of how to practice law, and i am now a better legal researcher, writer, and advocate."29 beyond improving these lawyering skills, the student also appreciated the oppor­ tunity to engage directly with core professional values. "making a concrete difference in the lives of two medically fragile children reminded me of why i came to law school in the first place: to address social problems such as poverty and health disparities by using the law to help underserved and marginalized individuals. ''30 even if you as a classroom professor have no intention of doing clini­ cal work yourself, or do not have the time to engage with the fund-raising and administrative tasks to start a new clinic, you could consider working with an already established health-related clinic at your law school to ex­ tend its interdisciplinary reach.31 if you have contacts with local health providers, for example, you could pave the way for your school's clinic to have a physical presence on the provider's premises, so that students can do direct client intake and collaborate with other health professionals in that 28. see, e.g.. collaboration between law and medical students benefits teenager with a disability, ga. st. univ. coll. law (apr. 7, 2011), http://law.gsu.edu/ clhs/6547.html?id=552; lessons learned from partnership, ga. st. un!v. coll. law (jan. 1, 2010), http://law.gsu.edu/clhs/6663.html?id=488. 29. jena jolissaint, help clinic award recipient reflects on public interest law in action, ga. st. univ. coll. law (apr. 19, 2011), http://law.gsu.edu/clhs/6539.html?id=556. 30. !d. 3l. a "health-related" clinic is a broad concept: it can include obviously health­ related subjects-like hiv i aids, disability, and mental health-as well as clinics whose clients face repetitive health-related challenges, such clinics focusing on domestic violence, elder law, or children's rights. the key question to ask when considering adding an interdis­ ciplinary dimension to an already-existing clinic is whether the addition of a health-related professional to the legal team-such as professionals in medicine, nursing, social work, psy­ chology, public health, or health administration-would improve client counseling and rep­ resentation. if yes, you can help your clinical faculty strategize about how to collaborate with such professionals. 2012] developing skills and valves in law teaching 425 setting. aside from all the professional skills and traits that are nurtured in any law school clinic, the interdisciplinary clinic extends students' domain knowledge through direct experience of another professional setting, devel­ ops their skills in teamwork and tolerance, and deepens the values of under­ standing and respecting other professional expertise and cultures. 32 v. externship collaborations like clinics, externship placements give students opportunities for de­ veloping lawyering skills and professional values in the context of a real., world workplace. classroom teachers can help provide these opportunities by identifying potential placements in their doctrinal fields, making the connections for their law schools, and recommending their adoption in the school's externship program. 33 this effort certainly takes less time than setting up an in-house clinic, and still similarly benefits students by opening up new opportunities for learning in the context of an industry and doctrinal field oflaw. faculty collaboration with the extemship placement supervisors can also benefit the faculty member's own teaching. for example, for over a decade i have been working with professionals at the centers for disease control and prevention (cdc) in atlanta, in particular the people who first established cdc's public health law program and attorneys with cdc's office of the general council.34 through these collaborations, we estab32. see, e.g., shannon mcnulty, doctors are like lawyers, ga. st. univ. coll. law (jan. 10, 2010), http://law.gsu.edu/clhs/666lhtml?id=489. 33. in addition to promoting new extemships in your field, and in light of the seam­ less-web nature of legal fields with much overlap across them, you may discover that your law school already has extemships related to your field which you (and the students) might not initially connect as related to or useful in your legal field. our health law program cate­ gorizes as "health-related" extemships broadly to include: public health law extemships with the centers for disease control and prevention; business administrative law externship with the hhs office of the general counsel; health legislation and litigation with the geor­ gia dept. of community health; regulation externship with the georgia hospital associa­ tion; elder law extemship with the senior citizens law project of the atlanta legal aid society; domestic violence law and juvenile law externship with the atlanta volunteers foundation; environmental law extemship with the federal epa; and alternative dispute resolution extemship with the fulton county state court. 34. georgia state law students have benefitted enormously from the collaboration between cdc and the law school over the years. the cdc colleagues with whom we have worked closely are the former co-directors of the cdc's public health law program, rich­ ard a. goodman, md, jd, mph, and anthony moulton, phd, as well as cdc's legal coun­ sel, former legal advisor gene w. matthews and paula kocher, current deputy associate general counsel, cdc branch of the hhs office of the general counsel. gene matthews was our first faculty fellow at georgia state law, and among other projects, he worked with professor sylvia caley and law students in her health legislation and advocacy class (see infra notes 44-49 and accompanying text) on obtaining passage of the post-katrina corporate good samaritan act, which is designed to encourage businesses and nonprofits to coordinate relief efforts with state agencies during public emergencies. see students ' class work becomes law, ctr. for law, health & soc'y newsl. (ga. st. univ. coil. law, 426 indiana health law review [vol. 9:2 lished new extemships at cdc, a new class on public health law at the law school taught by these professionals, and public educational programming on public health law. while we were creating these new educational oppor­ tunities for our students, i deepened significantly my own understanding of critical issues in public health law. diane hoffmann, professor of law and director of the law and health care program at the university of maryland's francis king carey school of law (um carey law), has developed an exciting innovation in extemship-related teaching. she has created a health law practice workshop that bridges the school's many health law extemships though a weekly classroom experience that all health law externship students attend.35 the goal of the workshop is to help law students make the transition from school to the legal workplace. because the approximately fifteen students . in the workshop are engaged in distinctly different practice settings, what the workshop provides that is missing from typical doctrinal courses is the opportunity to gain a broad perspective on the wide variety of potential em­ ployment settings and career options in health law beyond the traditional law fltttl, as well as the opportunity to appreciate the role of lawyers in different settings and how that affects the work they do. 36 . for two credits, students who are currently, or who were in the previ­ ous semester, in a health law externship meet weekly to discuss a variety of substantive law, professional ethics, personal values, political, and practical issues that have been raised in the context of real-world case studies devel­ oped by practitioners (who may be the extemship supervisors). students are also encouraged to engage in self-reflection about the work they are do­ ing, their own work style and values, the quality of the supervision they are receiving, and the culture of the organization they are working in. while the students gain domain and substantive knowledge and prac­ tical lawyering skills in the context of their own individual extemship placements, the workshop lets students learn what goes on in the other ones. students are also given writing assignments that incorporate an array of le­ gal resources familiar to health lawyers but not generally to law students.37 atlanta, ga.), fall 2008, at 8, available at http://www.law.gsu.edu/clbslpdf7newsletters/ fall_2008_newsletter.pdf. 35. diane e. hoffmann, a health law practice workshop: bridging externship placements and the classroom, 37 j.l. med. & etihcs 513 (2009). this kind of classroom workshop that brings students together from many externships to "compare notes" could easily be adapted to other legal fields. 36. id at 513. taking advantage of partnerships in its local community, um carey law has over a dozen health law externships, "including placements with in-house counsel offices at local hospitals; federal health agencies such as cms, fda, and nih; the u.s. attorney's office; the office of the maryland attorney general worlcing with the state health occupation boards or the medicaid fraud control unit; not-for-profit advocacy organ­ izations such as families usa; trade associations such as bio (representing biotech compa­ nies); and health committees or subcommittees on capitol hiu." id. · 37. this includes "oig fraud alerts and opinions, cms manuals, state medicaid plans, state attorney general opinions, and other agency guidance docunients." id at 517. 2012] developing skills and values in law teaching 427 the workshop encourages students how to think like a lawyer, which in­ cludes strategic thinking, big-picture problem solving, and the habits of self-reflection and self-learning. it also teaches students how to think like an employee-about how you get things done, about where you go for help, about the strengths and weaknesses of your supervisor, about how to juggle multiple assignments from multiple su­ pervisors, about the structure and goals· of the organi­ zation in which they are working, and how the lawyers help or hinder the organization to reach those goals.38 hoffi:nann hopes that her students are more ready for practice than she was when she graduated from law school. she designed the workshop to prepare students not only to tackle their first substantive work assignment, but also to help them to determine what kind of work they want to do, what kind of organizational culture they want to work iti that aligns with their personal goals and values, and how to function professionally and success­ fully in that setting. vi. working witii government a. working with federal government. hoffi:nann's colleague at um carey law, professor and former dean karen rothenberg, has undertaken a different kind of teaching innovation, which gives students real-world experiences to engage in actual policy mak­ ing. rothenberg has collaborated with benjamin berkman, deputy direc­ tor of the bioethics core at the national human genome research institute (a part of the national institutes of health (nih)), an agency that is being asked to provide ethical and legal guidance in the rapidly evolving field of genomic science. scientists and institutional review boards (irbs) across the country are grappling with how to design research protocols involving human subjects and next-generation genomic sequencing technology. ethi­ cal, legal, and policy issues abound, such as how to manage incidental or secondary findings arising from the research. berkman and rothenberg saw that a new collaboration between um carey law and the nih could create an opportunity to engage law students who were interested in combining science and law by "doing health poli­ cy," yet who often have little understanding what that means or how to do 38. /d. at 516. 428 indiana healtii law review [vol. 9:2 it.39 working in the policy arena themselves, they found that "[c]lassroom education, and its emphasis on legal theory, is insufficient to prepare law students with an interest in health and science policy for future careers in this field. ,.4o they decided to develop a workshop that would expose law students to some of the real-world, cutting-edge legal, ethical, regulatory, and scien­ tific policy questions facing the nih. over the course of the five-credit workshop, the students interviewed legal, scientific, and policy experts. they engaged in fieldwork observing and critiquing irbs and undertaking a qualitative study of irb members' attitudes. students wrote individual papers that analyzed-and offered concrete proposals for addressing­ specific policy issues. collaboratively, they created a consensus document that synthesized their individual research and that they presented to twenty high-level agency leaders and policy makers. berkman and rothenberg wanted students to experience all the chal­ lenges and steps involved in the policy-making process, including research, politics, deadlines, negotiation, conflict, and presentation of proposals. they also wanted to expose law students to the tools. and methodologies needed to use and interpret empirical data. and like hoffinann, they want­ ed to broaden their students' vision as to possible directions their careers could take beyond the traditional law firm setting. this pedagogical exper­ iment gave these professors "a unique opportunity to explore what might happen when legal educators push law students beyond their comfort zones.'.41 beyond the knowledge gained in researching their specific policy is­ sues, the students gained domain knowledge about the real-world workings of scientific research and government agencies. they learned the skills of getting up to speed quickly in a new field. they learned how write and speak so that non-lawyers could understand them. they learned about teamwork and resolving conflicts through developing the group's consensus document. they practiced how to translate thirty-page research papers (some of which the faculty hope will be publishable) into five-minute sum­ maries. they learned how to frame matters in light of practical politics. because the students were working on important and unsettled questions actually facing the nih, ''they felt that their work might actually influence real policies.'.42 all of these skills and experiences allowed the law students to realize their faculty's ultimate goal: "[to] help them transition from being law students with an interest in health care to being lawyers engaged in the 39. benjamin e. berkman & karen h. rothenberg, teaching law students to be poli· cy-makers: the health and science policy workshop on genomic research, 40 j.l. med. & ennes 147, 147 (2012). 40. id. 41. ld at 151. 42. id 2012] developing skills and values in law teaching 429 making of health and science policy.'"'3 b. working with state government professor sylvia caley at georgia state law offers a year-long (two­ semester) course, called health legislation and advocacy, which gives stu­ dents the opportunity to collaborate with non-profit community organiza;. tions to develop new legislation for potential passage by the georgia general assembly.44 during the fall semester, the law students work in teams of two or three and meet with their community partners to learn (us­ ing the skills of appreciative inquiry and active listening) about the prob­ lems that these community organizations think might be constructively addressed through legislation.45 each student team then researches ·their community partner's issue, devises a possible legislative solution; and drafts a proposed bill and memo explaining it to their partners. the team then meets twice more with their community partner to discuss their bill's feasibility, suggest revisions, identify potential sponsors, and strategize for its introduction in the next legislative session. to give students a big-picture sense of the legislative process, during the fall semester caley brings in community experts to meet with the stu­ dents and discuss the real world of law making. these guest speakers have included legislators from both political parties, other government officials, lobbyists who work for advocacy groups, state budget experts, and media experts who· report on the georgia legislature.46 these guest speakers give students invaluable domain knowledge about the political and economic issues that directly impact how the legislative and executive branches actu­ ally work. said one third-year law school about a class taught by an expert on georgia's budget and revenue: "i had no idea the extent to which geor­ gia • s fiscal policy impacts every aspect of how our government operates. '"'7 during the spring semester-which overlaps with our legislative ses­ sion from january to april each year-the students are down at the capitol they observe up close how the sausage gets made: they work with the leg­ islative sponsor and community partner as the bill is introduced, considered 43. id at 153. 44. students learn first-hand about law-making at the state capitol, ga. st. univ. coll. law (mar. 10, 2011), http://law.gsu.edu/clhs/6572.html?id=540. before introducing this course, caley researched other similar offerings at the university of new mexico (de­ veloped by prof. robert schwartz) and saint louis university (developed by prof. sidney. watson). 45. these community organizations have included the georgia advocacy office, georgians for a healthy future, and children's healthcare of atlanta, the public health division of the former georgia department of human resources, and the barton child law and policy center at emory university school of law. 46. megan daugherty, students learn about health policy and lawmaking from lo­ cal experts, ga. st. univ. coll. law (feb. 3, 2012), http://law.gsu.edu/clhs/7624.html. 47. id 430 indiana health law review [vol. 9:2 and debated in committee, and with luck and perseverance, gets passed they help prepare testimony, floor speeches, and community briefs, and attend committee hearings and track the progress other health-related bills. beyond developing the lawyering skills of research, drafting, memo writing, and interviewing and counseling, the students in this course are also expanding their approaches to problem-solving. they are developing their skills in collaboration and consensus building, strategic and systems thinking, creative thinking, and communicating with diverse people includ­ ing legislators, lobbyists, and legislative staff. they are gaining domain knowledge about the legislative process, who the players and stakeholders are, and what influences outcomes in the process. they are also gaining a broader vision of their community, a sense of what it takes to improve it, and possibly increased motivation to commit to promoting justice in the future through law reform. "working with my community partner was both challenging and re­ warding. no other experience in law school is quite like it," said a law stu­ dent who recently graduated. "while clinics teach you to counsel and advise clients, working with our community partner was instead a collaborative effort with other professionals, each bringing different skills to the table. '"'8 the other interdisciplinary graduate and professional students who participate with the law students in this course similarly benefit. "i saw firsthand the intricate role that community partnerships have in influencing health policy and, for better or worse, the type of political capital that is necessary to effect change," said a morehouse medical student who joined the class during his fourth-year elective rotation. ''this experience infected me with a certain sense of social and political responsibility. for the first time i really felt i grasped what it takes to go past the rhetoric. i might like a seat at the political decision-making table in the future.'o49 c. working with local government every year, professor elizabeth pendo at saint louis university school of law creates a service-learning project for her traditional doctrinal course ondisability discrimination law. 5° one year she created a project for her students that related to the research she had been recently undertaking concerning barriers to health care for people with disabilities. in particular, 48. students learn first-hand about law-moking at the state capitol, supra note 44. 49. paul mello, medicine meets law: a medical student's reflections, ga. st. unn. call. law (mar. 22, 2011), http://law.gsu.edu/clhs/6566.html?id=543. 50. elizabeth pendo, a service learning project: disability, access, and health care, 38 j. l. med. & ennes 154 (2010). for a discussion about incorporating service-learning projects into doctrinal classes as a way to expand opportunities for law students to engage in the third carnegie apprenticeship, see laurie morin & susan waysd~ the service­ learning model in the law school curriculum, 56 n.y.l. sch. l. rev. 561 (2011/2012). 2012] developing skills and valves in law teaching 431 she was looking at accessibility requirements and physical and architectural barriers under the american with disabilities act. she learned that a stretch of the street near her law school was not accessible to people with disabilities because the two of the curbs were not cut. she chose this situa­ tion both to create a real-world learning project for her students and to actu­ ally fix a problem that was right in their neighborhood. pendo had several goals for including a service-learning project in her otherwise largely classroom course on disability law. she wanted her stu­ dents to apply and reinforce their knowledge of doctrinal law issues under the american with disabilities act (ada) in a real-world context. she also wanted to introduce other skills and professionalism issues that had been identified by the carnegie report: i also wanted students to develop lawyering and ad­ vocacy skills, such as working in teams, consulting effectively with experts, gathering evidence and doc­ umenting a case, problem-solving through local and administrative processes, framing effective written requests, and making connections in the community. i hoped it would provide a meaningful context for ex­ ploring issues and tensions underlying disability law and the disability rights movement . . . a project could provide an opportunity . . . to foster a sense of engagement and responsibility central to civic profes­ sionalism. and yes, i did want those curbs cut. 51 the students first had to research the law and guidelines regarding public rights-of-way under the ada. they then went outside and, working with an architect with expertise in designing accessible public spaces, they surveyed the site during class time and identified several accessibility prob­ lems. then they took the matter to city hall, meeting with and drafting a formal request to the commissioner on the disabled for saint louis to cor­ rect these problems. the project ultimately resulted in getting the curbs cut. it also resulted in achieving pendo's other goals for her students. as one of her students later observed, the project "taught me more than just the law of title ii. it taught me how to become an advocate for people living with disabilities in st. louis."52 pendo succeeded in meeting the carnegie report's challenge to connect legal educators, practitioners, and the public they are supposed to serve. as another student said, "if more courses inte­ grated such real life experiences allowing students to touch the world, i be51. pendo, supra note 50, at 154-55. 52. id. at 156 (internal quotation marks omitted). 432 indiana health law review [vol. 9:2 lieve we would see more conscious crops of attorneys being produced."53 vii. academic interdisciplinary partnerships one of the most rewarding teaching experiments for me has been holding joint classes with medical students and law students. my faculty colleagues at emory's school of medicine and center for ethics for many years have held ethics classes for third-year medical students during their clinical rotations at grady memorial hospital, a teaching hospital in down­ town atlanta. for many years, i co-taught with these faculty as a faculty fellow with emory's center for ethics. during some of those years, i brought my law students who were enrolled in a seminar on law and medi­ cal ethics to the classes during the medical students' pediatrics, obstetrics, internal medicine, and psychiatry rotations. the classes were structured around ethical challenges in either hypothetical patient cases or actual cases that the medical students were handling during their rotations. i always thought that the faculty's best teaching during these joint ses­ sions was when we said nothing. teaching with our mouths shut allowed the law students and medical students to talk to each other. we broke them into small groups, with both law and medical students in each group, to dis­ cuss the cases and identify the medical, ethical, legal, and other practical challenges that they presented. among other things, the law students di­ rectly experienced how deeply runs the medical profession's distrust of the legal profession and how to react gracefully to dispel biased assumptions. when they realized the medical students thought they were legal experts, they had to explain in understandable, non-legalese ''what the law says," in all its grayness, and how it might be applied in any given case. they gained appreciation and respect for how uncertain medical practice is, and they developed sympathy for the professional complexities facing their counter­ parts in medical school. for their part, the medical students were surprised to learn that there were law students who were studying law not in order to sue physicians, but rather to work with them in a transactional practice or on the defense side of medical malpractice litigation. the medical students experienced how un­ certain the law can be, and began to appreciate why "it depends" may be the correct even if undesired answer-and to develop a willingness and pa­ tience for discussing all the factors that a resolution may depend on. they had to communicate sufficient medical background in non-medicalese so that the interdisciplinary groups could collaborate on resolving the ethical issues· that were at the intersection of the medical and legal aspects of a case. the students came away with increased respect for their sibling pro53. id at 157 (internal quotation marks omitted). 2012] developing skills and values in law teaching 433 fessionals. they gained insight that there may be ·more complexity and fewer clear-cut answers in the professional practice of their counterparts than they had initially assumed. they experienced that while they can begin to tackle a problem with the seemingly-obvious starting assumptions, perspectives, and approaches of their own profession, there are other pro­ fessionals who can just as sincerely begin from diametrically opposed start­ ing points. since there will likely not be initial consensus on which is the ''best" way to begin attacking a problem, all students had the opportunity to learn how to listen more appreciatively and with a more open mind, and to withhold judgment for a time until they have heard more before concluding what the right thing to do would be. many important real-world skills and values can be developed through interdisciplinary partnerships, even while being undertaken in an academic classroom· setting. beyond increased domain knowledge about their coun­ terpart profession, both groups of students had the opportunity to practice the real-world skills of listening, communicating, avoiding premature judgment, flexibility, openness to hearing other perspectives, collaboration, and tolerance and respect for (if not complete agreement with) other disci­ plines and professional cultures. my law students also engaged in self­ reflection about what they experienced and learned in the joint sessions through short essays that they wrote immediately after the classes. other law professors have written about the rich learning environment provided by an interdisciplinary class of professional students, giving abun­ dant examples and illustrations for the benefits and challenges of develop­ ing interdisciplinary academic partnerships. 54 vill. partnerships with orner interdisciplinary stakeholders a. hospitals professor paul a. lombardo at georgia state law recently developed a two-credit independent study project for two law students to work with the medical ethicist, jason lesandrini, at grady health system in down54. for medical-legal teaching examples, see, e.g., susan b. apel, teaching law and medicine on the interdisciplinary cutting edge: assisted reproductive technologies, 38 j. l. med. & ennes 420 (2010); jennifer s. bard. what we in law can leamfrom our col­ leagues in medicine about teaching students how to practice their chosen profession, 36 j. l. med. & ennes 841 (2008); marshall b. kapp, health law teaching in medical schools: balancing the different roles, 38 j. l. med. & ennes 863 (201 0); elizabeth tobin tyler, teaching social justice and-health: professionalism, ethics, and problem-solving in the medical-legal classroom, 38 j. l. med. & ennes 701 (2010). for a reflection on teach­ ing law and public health students, see peter d. jacobson, personal reflections on teaching health law in a school of public health, 39 j. l. med. & ennes 285 (2011 ). for an educa­ tional innovation with law, medical, engineering, policy, and public health students, see roberta m. berry, problem-based leaming regarding "fractious problems" in health law: reflections on an educational experiment, 39 j.l. med. & ennes 694 (2011 ). 434 indiana health law review [vol. 9:2 town atlanta. 55 the students had the opportunity to go on hospital rounds in the neurology intensive care unit with the health care team, attend ethics committee meetings, and undertake data inputting and analysis for a project examining the ethics committee's workload and outcomes. the students did background legal research, found other resources, and generally provid­ ed support to grady's ethics service. they also created a research project related to their interests. while this project was an experimental pilot pro­ ject as of this writing (it was undertaken in spring semester 2012), it has provided an extraordinary opportunity for law students to experience the real world of a hospital ethics service and hospital life from the perspective of the health care team. any attorney who represents hospitals knows how critical it is to have this understanding of the real world of health care pro­ fessionals in order to counsel them well. by going on medical rounds to the patients' bedsides, these law stu­ dents had the opportunity to shadow the health professionals as they went about their daily work. through shadowing, students developed domain knowledge and an understanding of the culture of health care institutions and professionals simply by being with them as they did their work. the bioethics committee members at grady come from many disciplines, in­ cluding medicine, nursing, social work, chaplaincy, and administration, and lesandrini has a philosophy background. thrown into this highly interdis­ ciplinary ring, the law·students learned about contributing their legal exper­ tise as part of a team, and learned to accept how different professionals' expertise contributes to solving a problem. sometimes, if this is someone's first exposure to the inner workings of a hospital, particularly an icu, gain­ ing such cultural literacy can be disorienting and create some culture shock, which itself is something good to learn to cope with. the law students were also involved in individual ethics case consul­ tations. in this context they were learning the skills of listening and observ­ ing, asking the right questions, and reserving judgment until more is known and understood. lesandrini emphasized the importance of listening skills and relationship-building in bioethics consultation services: it is both a listening "to" and a listening "for." there is so much to take in within each consultation that i often ask the students to listen "for" what the patients, families, and staff members say and don't say. it's al­ so important to listen "to" them, to make sure that the parties feel you are connected with them in the mo55. jason lesandrini, ph.d., in progress (health care ethics), m.a. (philosophy), has been grady's medical ethicist since 2008, and is also adjunct faculty at mercer university. for more information and to read the reflections of the two law students on their experiences during their semester at grady, see law students shadow grady health system medical ethicist, ga. st. univ. coll. law (july 12, 2012), http://law.gsu.edu/clhs/8032.html. 2012] developing skills and values in law teaching ment and truly care about what they have to say. (this assumes you actually do care--the parties will be able to tell right away if you don't care.)56 435 lesandrini and lombardo hope the students have developed some of the core competencies in bioethics consultation that have been identified by the american society of bioethics and humanities. 57 the students identi­ fied the particular competencies they wanted to focus on during the semes­ ter, and wrote reflective journals and undertook self-assessments on their experiences and progress. this project thus aimed both to extend domain knowledge about hospital workings through rounding and observation and to develop in the students the actual skills and character traits needed to be a successful part of a health care ethics service. b. public health professionals professor linda morton at california western school of law has de­ veloped a course called "problem solving and prevention in health care. "58 she partners with health professionals (several doctors and a public health professional) who have identified many public health problems in the san diego area. she groups her law students into teams, and tells them to imag­ ine that these health professionals are paying them as consultants to resolve some of these public health problems. in the past, the students' projects have addressed problems of alcoholism in the community, lack of school nurses to administer insulin injections, the mental health of children who witness domestic violence, the availability of unhealthy foods in vending machines at schools, and misallocation of vision-therapy resources for school children. 59 morton uses these real public health problems to teach law students the skills,60 attitudes,61 values,62 and methods63 of problem solving. in her 56. e-mail from jason lesandrini, re: law students at grady witii jason this semester (jan. 23, 2012, 9:25pm edt) (on file with the author). 57. am. soc'y of bioethics & human., core competencies for iiealtiicare etiiics consultation (2011). three categories of core skids competencies for healthcare ethics consultation are identified: (1) ethical assessment and analysis skills, (2) process skills (for conducting consultations and operating a healthcare ethics service), and (3) interpersonal and communication skills. jd at 22-24. also identified are core knowledge competencies and the key attributes, attitudes, and behaviors of ethics consultants. jd at 26-33. 58. linda morton, a new approach to health care adr: training law students to be problem solvers in the health care context, 21 ga. sr. u. l. rev. 965 (2005). more in­ formation about this course can be found in linda morton et al, teaching interdisciplinary collaboration: theory, practice, and assessment, 13 qunoopiac healm l.j. 175 (2010). see also linda morton, teaching creative problem solving: a paradigmatic approach, 34 cal. w. l. rev. 375 (1998) (discussing the creative problem-solving methodology she teaches). 59. morton, a new approach to health care adr. supra note 58, at 990. 60. jd. at 970 ("problem solving skills include listening, collaborating, empathizing, 436 indiana health law review [vol. 9:2 experience, students "learn problem solving best through a continuing, ex­ periential, real-world context.'.m less interested in their gaining a lot of substantive knowledge about health care law, she teaches problem-solving skills, attitudes, and values predominantly by allowing the students directly to experience them and self-consciously to reflect on them as they work on their team projects throughout the semester. morton has an initial intensive fourteen-hour training workshop in which she explicitly teaches some of these skills, including problem-solving methodology, listening, and creative thinking. for the rest of the semester, she reinforces other values (such as openness to critique, self-awareness, self-reflection, empathy, respect for differences, and respect for others' knowledge, opinions, and culture), skills, and attitudes (such as "giving up control, withholding judgment, asking the right questions, being persistent, being willing to change course, and looking at the big picture") during class discussion of each team's work and through students' oral and written re­ flections on self-learning and the group process. 65 another professional attitude that morton thinks is important to devel­ op in law students is self-confidence. all of the students in her course suc­ cessfully proposed options for resolving their issues in collaboration with their community stakeholders. in reflecting on her class, she believes her students gained in self-confidence and self-learning through this opportuni­ ty to tackle a messy problem, experience frustration and setbacks, and work together to resolve it.66 ix. real-world research collaborations with students government and non-government agencies, legislative bodies, and other policy makers can offer law faculty opportunities to engage in realworking in teams, seeing the big picture, fact-finding, communicating, consensus building, making good judgments, creative thinking, assessing needs, working with other disciplines, and asking the right questions."). 61. id at 97(}-71 (''problem solving attitudes involve being open-minded, resilient, persistent, non-judgmental, humble, respectful, curious, trusting, aware of one's perspective and bias, able to accept criticism, willing to change, willing to deal with ambiguity, and will­ ing to explore and stretch one's limits.''). 62. id at 971 ("values, which certainly overlap with skills and attitudes, include re­ spect for relationships, respect for differences, respect for culture, respect for others' knowledge, appreciation for decentralized decision-making, willingness to admit one's limi­ tations, inclusiveness, creativity, self-awareness, and self-reflection."). professor morton later expanded on the intrinsic values she hopes that students develop in her colleague's and her own courses on interdisciplinary, collaborative problem solving. see weinstein & mor­ ton, supra note 10. 63. id at 970 (''problem solving methods include those we associate with adr: dia­ logue, negotiation, appreciative inquiry, mediation, facilitation, arbitration, ombudding, sys­ tems design, and most importantly, any combination of the above processes.j. 64. id. at 972. 65. id at 977-79. 66. id. at 985. 2012] developing skills and values in law teaching 437 world advising, research, and the preparation of white papers, reports, presentations, and publications. such task forces or study committees can offer great opportunities for students to become involved as well. some­ times, as with government-funded research, there can be funding lines for graduate students participating in the research. students can become deeply engaged in these projects when they know they will have real-world impact. a good example is the nlli-funded research that professor leslie e. wolf at georgia state law has undertaken with duke university faculty on assessing the use and understanding of certificates of confidentiality in hu­ man subject research.67 in addition to background legal research, the pro­ ject surveyed and interviewed ir.b chairs and interviewed legal counsel on their use and understanding of these certificates. working as a team for two years, her three law student research assistants met weekly or bi-weekly with wolf to report on their progress, discuss strategy, and identify addi­ tional avenues to be explored. along with preparing written memos, the students drafted a section of a law review article to be published after the research findings are officially reported. they also provided short summar­ ies (strict word limits are imposed) and input into the presentation on pre­ liminary findings that wolf gave to the nlli. she also took the students with her when she presented at a regional conference, and had them spend a day with their duke counterparts to dis­ cuss the findings and next steps for dissemination.68 "despite how much we knew about the project from our work, meeting with the whole team for an entire day really opened our eyes to the direction the project was headed and put our work in context with the overall goals and aims," said one stu­ dent.69 an unusual (for law students) aspect of the research was the need to prepare for and evaluate the interviews in a scientific, systematic way. wolf involved the students in developing a coding guide for the interview transcripts based on important legal questions their research had identified. while new to the law students, the skills they learned are readily translata­ ble to legal practice. wolf observed, ''for example, the process of going through the transcripts, coding them, and looking for common themes is analogous to what lawyers do in going through discovery, sifting through the documents, answers to interrogatories, and deposition transcripts to build a case."70 a second student noted: "my friends who work in public health have been impressed that i am learning skills like qualitative coding 67. wolf presents at research ethics conference, ga. st. univ. coll. law (feb. 1, 20 12}, http:lllaw.gsu.edulclhs/7626.html?id=590. 68. gra 's work on nih project culminates in road trip, ga. st. unjv. coll. law (june 4, 2012), http://law.gsu.edu/clhs/7958.html. 69. id 70. e-mail from leslie e. wolt: re: happy new year-and a question about your research (jan. 3, 2012, 10:09 am ed'i) (on file with the author). 438 indiana health law review [vol. 9:2 in law school."71 beyond building research and writing skills in a substantive field, wolfhopes··the students learned three overall lessons from this project: (i) that strong collaboration skills are important for lawyers to develop to suc­ ceed on a complex project; (2) how important written documentation is to allow everyone on the team to be able pick up the project where someone else who may be unavailable has left off; and (3) that lawyers need to be able to write for different audiences for different purposes-in this case, readers and reviewers from legal, scientific, research, and government backgrounds. when they traveled with her to see the results of their work formally presented and met with their duke collaborators, the students were also developing professional identity and self-esteem as they saw that their work had real-world impact. a third student observed: "it was fascinating to participate in the meeting and see the collaboration at work. we tend to think of writing as solitary, but we saw proof that working together can lead to better work."72 another good example of real-world research with students is georgia state law professor jonathan todres's collaboration with four law students on a project on international human trafficking. the united nations inter­ agency project on human trafficking invited todres to contribute to its reach initiative.73 this initiative seeks to better understand human traf­ ficking from asia to other regions around the world in order to improve assistance to victims and prevent this exploitation. the research undertaken by todres and the students involved the trafficking of people from the greater mekong sub-region to the united states. 74 todres and his students produced several reports and final recommen­ dations for the reach initiative. their research examined sex and labor trafficking in the united states as well as. responses to trafficking by gov­ ernment and non-governmental agencies. in addition to research and writ­ ing skills, the students developed skills in problem-solving, creative brainstorming, working as a team, and coping with complexity. todres ob­ served that they also learned: the value of interdisciplinary approaches and the way in which law can work effectively with other fields to address human rights violations and other social prob­ lems. students also gained an appreciation of the im­ portance of understanding the context in which legal 71. gra 's work, supra note 68. 72. jd. 73. see also united nations lnter:.agency project on human trafficking, http://www.no-trafficking.org/ (last visited jan. 28, 2012). 74. todres and students collaborate on international trafftcking research, ga. st. univ. coll. law (feb. 10, 2012), http:lilaw.gsu.edu/clhs/6602.html?id=527. 2012] developing skills and values in law teaching issues arise and how that context shapes strategic de­ cisions and options developed in response to such problems. given the nature of the harm inflicted on victims of human trafficking, students were chal­ lenged at times to handle sensitive information. this provided students opportunity to develop profession­ ally and reflect on their values and how ultimately they want to use their legal training in the future. 75 439 acknowledging the complexity and challenges in undertaking traffick­ ing research, the students were undeterred and felt fortunate to be able to contribute to world-wide efforts addressing trafficking. said one student of his sense of contributing to the betterment of the global community, "this was one of the most rewarding projects that i have worked on in law school."76 a third illustration of real-world faculty-student research collabora­ tions involves georgia state law professor jessica gabel. she had eight law students in her forensic science class undertake research to present at the first annual world congress of forensics in dalian, china. by invita­ tion from the conference organizers, they designed a half-day session that explored the evolution, strengths, and challenges of various forensic disci­ plines, including arson, handwriting, firearms, fingerprints, digital foren­ sics, forensic anthropology, media forensics, and medical-legal death investigations. these students developed a sense of professional pride as pioneers: they were the only student group who had been invited to present a program at the conference, and theirs was the only law--oriented session. the stu­ dents developed skills in communicating with a range of professionals in other disciplines, as their program was one of the most highly attended at a conference that attracted over 400 forensic medicine, scientific, and crime experts. according to gabel, "our students engaged very well with the au­ dience, fielding questions from the world's top forensic scientists and law enforcement personnel. ,m under gabel's guidance, the students had thoroughly prepared their powerpoint slides to ensure·tbat their presentations were clear, direct, un­ derstandable, and accessible to the interdisciplinary audience that included many non-native english speakers. beyond research, writing, and presenta­ tion skills, the students also developed their sense of professionalism and professional identity. as the legal experts at the conference, they felt ac­ countable for the quality of their work. and they learned how to comport 75. e-mail from jonathan todres, re: research collaborationsyour team's reach project (jan. 26, 2012, 8:19am edt) (on file with the author). 76. id. 77. ld. 440 indiana health law review [vol. 9:2 themselves professionally in a professional setting, which is the best setting possible for learning professional behavior. among the many benefits that these research collaborations offer is the opportunity for law students to connect professionally and personally with their own faculty. one of the most influential factors in student learn­ ing is faculty-student interaction. this is particularly true with respect to students' developing a sense of professional ethics and values.78 x. field trips you have to admit it-field trips are fun. you can perk up any group of students by announcing that today, we're heading to the morgue. profes­ sor jessica gabel took law students in her forensic medicine class on a half­ day field trip to the dekalb county medical examiner's office, where they received technical training and observed autopsies. the students saw griev­ ing families and met hardened investigators and technicians. "it gave them a perspective on life and death that does not come through from the case book, and how forensics is more than just a medical report," said gabel.79 for her forensic evidence class, gabel has planned a student field trip to the u.s. army criminal investigation lab to tour the crime lab and look at the actual tests being performed. in the past, she has taken her students to the georgia bureau of investigation for a tour of the crime lab facilities to get a hands-on look at what goes into generating a lab report. why take field trips into the real world? they serve to build students' domain knowledge: their understanding of the institutional and profession­ al players in the industry impacted by the laws being studied in the class78. law school survey of student engagement, 2010 annual survey results, student engagement in law school: in class and beyond 9, available at http://lssse.iub.edu/pdf72010/2010_lssse_annual_survey_results.pdf (discussing the strong correlation between interaction with faculty and student gains in professionalism). see also law school survey of student engagement, 2006 annual survey results, engaging legal education: moving beyond the status quo 11, available at http:/ /lssse.iub.edu/2006 _annual_ report/pdf7lssse _ 2006 _annual_ report.pdf ("student­ faculty interaction was more strongly related to students' self-reported gains in analytical ability than time spent studying, cocurricular activities, or even the amount of academic effort they put forth . . . . in terms of developing a sense of professional ethics (defined as developing a personal code of values and ethics and contributing to the welfare of the com­ munity), the single most influential activity was student-faculty interaction. this includes talking about assignments, discussing ideas outside of class, email exchanges, and getting prompt feedback. in fact, student-faculty contact was more important to the ethical dimen­ sions of the practice of law than participating in such activities as pro bono work. intern­ ships, moot court, and law school organizations or the student's area of specialization or intended practice area."). 79. e-mail from jessica gabel, re: happy new year-and a question about your "field trips" with students (jan 3., 2012, 8:56am edt) (on file with the author). 2012] developing skills and values in law teaching 441 room. 80 they provide the critical context for learning legal concepts. stu­ dents can begin to think like lawyers when they understand the way the sys­ tem works for their potential clients-be it the health care system, law­ enforcement system, securities or tax systems, or any other regulated indus­ try or field. 81 deeper and more lasting learning takes place when legal con­ cepts and cases can be understood within the larger legal regime of the institutions and stakeholders who are regulated by them. acquiring such domain knowledg~ultural literacy and an under­ standing of what is really going on out there-may make students uncom­ fortable. professor michele goodwin has told about the time she took her students to a health law symposium in chicago spanning two days. on the first day, the symposium took place at a large law firm, and the students enjoyed the wealthy and privileged surroundings. on the second day, they went to the south side of chicago and heard congressional representatives and civil rights leaders such as the rev. jesse jackson discuss health in the context of poverty and disadvantage. some students did not enjoy the se­ cond day and complained to goodwin. recognizing that it had been an un­ settling learning experience, goodwin "advocates getting students out of their comfort zone to engage them in learning about difficult legal and so­ cial problems that arise in the context of people's health and access to health care,'.s2 especially if those are issues they are not otherwise inclined to learn about. as i have observed before, "[r]eal learning can go on whether the students like it or not.'.s3 xi. 8rjnging the real-world inside the classroom: guest speakers and skills projects in my early years of teaching, i viewed guest speakers, with their war stories about their glory days, as largely a waste of students' time. i was focused on the students learning the law and advancing the intellectual, ana­ lytical ball. i thought real-world partnerships in the classroom would be a distraction from that goal. also, because i was inexperienced in selecting and preparing my guest speakers, sometimes having them did not just waste time; their presence actually backfired. one doctor i invited to a health law class many years ago so alienated and offended the law students that i had to take time out from the next class to dispel the negative generalizations about the medical profession that the law students had drawn from his re­ marks. 80. see friedman, supra note 15. 81. see friedman, supra note 15, and accompanying text for a discussion of domain knowledge and culfuralliteracy. 82. charity scott, how well do we engage our students?, 35 j. l. mbd. & ennes 739,741 (2007). 83. ld. 442 indiana health law review [vol. 9:2 today, i see guest speakers as offering the potential, when carefully selected and prepared, to develop the students' understanding of excellent professional practice. excellent legal practitioners can be great role models for setting a high bar for lawyering skills, professionalism and ethics, and pro bono service to the community. as such, they can be invaluable teach­ ing aids for developing domain knowledge and real-world skills and val­ ues.84 i am less interested in having practicing lawyers teach substantive as­ pects of health law than in having them serve as role models for how excel­ lent lawyers practice law. role modeling can occur in a variety of contexts, such as discussing how they handled a recent or current case (when client confidentiality is not a problem); how they think about and deal with the law, their clients, and their opposing counsel; their philosophy of good law­ yering; and how they manage their personal and professional lives. i am amazed at how impactful good guest speakers can be. i recently learned from a law graduate of ours that after she heard two guest speakers from the centers for disease control and prevention in her public health law class, she decided to redirect her career path into the public health field. when i teach negotiation, i have invited two weu.:.respected attorneys who take a collaborative problem-solving approach to negotiation. they dramat­ ically help to reinforce for skeptical third-year law students that there is in­ deed room for win-win approaches in real-world lawyering, and that good client representation does not always depend on advocacy skills and an ad­ versarial approach that presupposes only win-lose outcomes. 85 there is no reason to limit to guests' participation to speaking or role modeling. my younger colleagues are developing innovative ways to in­ corporate guest speakers into their classes. an advocate of bringing the real world into her classroom through guest speakers, professor jessica gabel has developed her forensic evidence class as a "law lab" where students get case files and prepare them as if for trial. actual medical examiners and forensic analysts testify as witnesses in class in mock direct and cross­ examination settings. the students on the defense team get their own ex­ pert to serve as consultant while still in the classroom and in the context of mock trial conditions, the students get exposure to how forensic scien­ tists and investigators approach real cases, what matters to them and why, and how to apply legal concepts to the kinds of problems that arise in real­ world settings. georgia state law professor y aniv heled has developed a new semi­ nar on law and emerging technologies which featured six guest speakers who have legal, scientific, business, and engineering backgrounds and who 84. for an example of such positive role-modeling. see articles about professor hughes, supra note 14. 85. speakers discuss new models of negotiation practice, ga. st. univ. coll. law (mar. 18,2011 ), http://law.gsu.edu/clhs/6568.html?id=542. 2012] developing skills and values in law teaching 443 have been closely involved with developing new technologies. the speak­ ers introduced the students to a different new technology every week. at a minimum, this exposure developed students' domain knowledge about the real world of technology-saturated areas oflegal practice. heled's main goal was to develop their skills in writing and analysis (they were required to prepare a position paper in advance of each talk), asking the right questions, especially when dealing with experts (they were required to prepare questions in advance and engage in discussion with speakers), and developing flexibility and independence. on this last point, because technology changes so rapidly, heled hoped that the array of speakers would allow "students to gain mind-flexibility to enable them to approach new technological subject matters in practice with relative ease and without the typical neophobia/technophobia.'.86 even if you decide you do not have the time or inclination to find real­ world collaborators to work with you to help develop skills and values in your classroom, you can decide to begin looking for exercises and problems that students can work on in class.87 such problem-based learning can be better than traditional langdellian, case-method teaching in any event.88 although socratic dialogue may be more effective for learning than straight lecturing, educational reformers are calling for less talking by the professor and more student engagement in solving problems during class time. 89 xii. extracurricular activities while students should be doing most of the work in pursuing their ex86. e-mail from yaniv heled. re: your speaker series (jan. 22, 2012, 12:36 pm edt) (on file with the author). see also confronting the challenges of disruptive technologies, ga. st. univ. coll. law (june 7, 2012), http:lllaw.gsu.edulclhs/7960.html (heled observed that "[i]ntroducing the students to novel technologies is fun, but the real benefit for the students from this course is the development of the ability to hit the ground running when encountering new technologies in their practice."). 87. see, e.g., jonathan todres, beyond the case method: teaching transactional law skills in the classroom, 37 j.l. med. & ethics 375 (2009) (discussing how.to incorporate exercises and problems to teach four kinds of transactional law skills: (l) thinking ex ante, (2) risk assessment and allocation, (3) drafting, and (4) negotiation). 88. alan m. lerner, using our brains: what cognitive science and social psycholo­ gy teach us about teaching law students to make ethical, professionally responsible, choices, 23 quinnipiac l. rev. 643, 695-705 (2004) (describing the use of problem-based learning in law schools); westbrook, supra note 2, at 261 ("for lawyers in transactional practices, the langdellian model is particularly out of touch for the simple reason that trans~ actionallawyers rarely have much to do v.ith appellate cases."). 89. see, e.g., emily hanford, physicists seek to lose the lecture as teaching tool, npr (jan. 1, 2012), http://www.npr.org/2012/0l/01/144550920/physicists-seek-to-lose-the­ lecture-as-teaching-tool (discussing the need to shift the professorial ·role from being the "sage on the stage" to being the "guide on the side" for their students); see also claudia dreifus, a conversation with eric mazur: using the "beauties of physics" to conquer sci­ ence illiteracy, n.y. times, july 17, 2007, at f2, available at http://www.nytimes.com/ 2007/07/17 /sciencell7conv.html?pagewanted=all. 444 indiana health law review [vol. 9:2 tracurricular activities, faculty can have input in making professional con­ nections for them and pointing them in constructive directions. a. activities outside of a particular class developing extracurricular activities in real-world settings can help students gain important domain knowledge about the complex social, busi­ ness, regulatory, economic, and ethical challenges that the players in an in­ dustry face every day. classroom faculty who have contacts with these industry players are in a good position to make a connection for their stu­ dents that will allow them at least a glimpse into that world. it may only take a few phone calls on your part to set up something up, and the benefits for your students can be enormous. lawyers and executives are often de­ lighted to be asked to share some of their experience with aspiring students, particularly if the students will come to them (which is even better for cap­ turing the reality of the setting, and to which students may not otherwise not be able to gain access). for example, a number of our alumni work at cdc in atlanta, and one of them recently offered to arrange an afternoon workshop for current law students next semester. the alumni will discuss the wide variety of work they do--from the more traditional law practice setting of the office of the general counsel to the work done in the public health law program to the diverse kinds of policy work undertaken by those with law degrees across the cdc campus.90 the workshop will take place at cdc, with the opportunity to visit some of the facilities, including the emergency opera­ tions center al\d the cdc museum. because of the limited exposure students are usually given in law school classes to the types of work that real lawyers do, they often cannot imagine there could be opportunities for them in any setting other than a law firm or in-house counsel office. this opportunity-in the real-world cdc setting-gives law students a chance to imagine different career routes, as well as to network in a friendly and supportive professional envi­ ronment with graduates of their law school. ·another example of faculty helping to create extracurricular opportu­ nities for students comes from the beazley institute for health law and policy at loyola university chicago school of law. a few years ago, their faculty undertook to reexamine their health law curriculum in light of car­ negie principles and with the goal of better preparing their graduates for the challenges of 21st-century health law practice. this review entailed con90. for a discussion of the wide variety of work these alumni do at cdc, see generally crr.. for law, iieal1h & soc'y newsl. center briefings special edmon (ga. st. univ. coli. law, atlanta, ga.), spring 2012, available at http://law.gsu.edu/clhs/files/ cdc_newsletter_web.pdf: for a discussion of the wide variety of work georgia state uni­ versity college of law alumni do at cdc. 2012) developing skills and values in law teaching 445 sidering how to develop both substantive knowledge and lawyering skills in health law, as well as how to give students opportunities to apply their knowledge and skills in real-world contexts.91 the faculty specifically considered what extracurricular activities out­ side the classroom might enhance their students' knowledge of the health care industry and their practical skills. according to lawrence singer, di­ rector of the beazley institute, "[c]arefully crafted extracurricular events can re-emphasize the balance of substantive and practical skills learned in the classroom.'.n they arranged for students to take a tour of loyola uni­ versity medical center and to attend a meeting with the general counsel and other key officials. the experience was so well received that it was repeated the next year. this field trip-undertaken outside of a particular class, and open to any interested law student-immersed the students in considering the busi­ ness management aspects of health care. basic day-to-day concerns, such as staffing issues and charity care, introduced students to the real world of health administration and health administrators.93 these people are the kinds of industry players who become clients after the students graduate. understanding their practical concerns and challenges can help students appreciate what their future clients will want from them: context-sensitive legal counsel and advice. b. moot court and mock trial beyond encouraging students to enter regional or national moot court competitions in the relevant doctrinal field,94 classroom teachers can volun­ teer to bench a few practice sessions while their school's teams are prepar­ ing for the competition. such faculty participation provides an opportunity for direct faculty-student involvement outside of the classroom, which has been demonstrated to be key to students' engagement during law school and their development of professionalism and professional identity.95 in addi­ tion, classroom faculty can put the students in touch with practicing attor­ neys in the relevant legal discipline to help bench the students. we have done this for our students competing in the national health law competi­ tion, for example, and the students benefit from ''upping the ante" in their preparation by going to law firms and practicing their arguments before 91. lawrence e. singer & megan bess, combining pedagogy and practice: creating a 21st century health law curriculum, 31 j. l. med. & ennes 852 (2009). 92. id. at 855. 93. id. 94. see national health law moot court competition, s. ill. univ. sch. of law, http://www.law.siu.edu/healthlaw/healthlawmootcourt%20.php (last visited feb. 4, 2012), for an example of an annual health law moot court competition. 95. see e-mail from jessica gabel to author, supra note 79. 446 indiana health law review [vol. 9:2 health law attorneys and litigators.96 going a step further, a classroom teacher can collaborate with a litiga­ tion professor or practicing attorney and with faculty from another graduate or professional school to put on a mock trial with law students and other professional students. for example, some law schools have partnered with medical schools to put on mock medical malpractice trials.97 other profes­ sional programs (e.g., health administration, psychiatry) have partnered with lawyers and have used mock trials to deepen. their own students' and professionals' appreciation of the legal system, the importance of documen­ tation, and development of professional skills.98 interdisciplinary mock trials typically place law students in the roles of attorneys, and the other professional students in the roles of the parties or experts. the benefits include increasing the real-world feel and intensity to the simulation. "[t]he law students get to match wits with a real doctor, rather than another law student. reading from a script," said a surgeon who helped to put such a program together at the university of pittsburgh.99 · said a law student who cross-examined a medical resident serving as an expert witness in this recent mock trial: ''to have an actual doctor who knows what they are talking about, who you can't bully into saying what you want them to say, who knows more than you-that's a valuable experi­ ence to have early on so you know what you're getting yourself into."100 another benefit is the opportunity to deepen each profession's appre­ ciation for the expertise and perspectives of the other and to open lines of 96. see students compete in national moot court competition, ga. st. univ. coll. law (jan. 31, 2012), http://law.gsu.edu/clhs/7614.html?id=586; see also two teams advo­ cated in national moot court competition, ga. st. univ. coll. law (mar. 10, 2011), http://law.gsu.edu/clhs/6578.html?id=537. 97. taryn luna, pitt mock trial pits those studying law against those studying medicine, pitisburgh post-gazette, http://www.post-gazette.com/pg/11339/1194147499-0.stm (last updated mar. 12, 2012) (describing mock trial with university of pittsburgh law students and medical residents); see also students try moot case with medical resi­ dents, penn st. law (mar. 28, 2010), http://law.psu.edu/news/treating_medical_errors_moot (describing mock trial with penn state law school students and pediatric residents ftom penn state hershey children's hospital). 98. randall carter jenkins & christy harris lemak, innovative teaching for health law: a case study of a hospital medical malpractice lawsuit simulation, 24 j. health admin. enuc. 43, 44 (2007) ("the goal of the [semester-long medical malpractice lawsuit] simulation is not only to help increase participants' awareness of the legal system but also to improve their job performance by highlighting how the legal system scrutinizes a variety of treatment decisions, from documentation to policy implementation, made daily by healthcare professionals."); see also stewart levine & henry pinsker, the mock trial in psychiatric staff education, 22 bull. am. acad. psychiatry law 127 (1994), available at http://www.jaapl.org/content/22/11127.full.pdf ("the mock trial [program for students and interdisciplinary staff of the department of psychiatry at beth israel medical center] is not only an excellent strategy for teaching about the interface between psychiatry and the law, but also for teaching about malpractice, documentation, and medical reasoning."). 99. luna, supra note 97. 100. id 2012] developing skills and values in law teaching 447 interdisciplinary communication. "today, two honorable professions communicated better to understand each other's views, both in general and to the specific question of remedying medical error," said professor gary gildin, who helped to organize a mock trial with law students and medical residents at penn state.101 "we do not have all of the answers, but an event like this gives us the process for asking questions."102 while the mock trials are simulations, the collaboration with non-law professionals brings reality into them by exposing the differing real-world concerns and perspectives of the other professions. professors at the uni­ versity of lllinois have undertaken a number of interdisciplinary simula­ tions, including one for law students, medical students, and physicians involving a simulated patient complaint against a physician and regulatory investigation. they have found that the interdisciplinary component signif­ icantly improves the students' learning: the aura of reality introduced by having outsiders participate in legal skills role plays has had a counter­ intuitive effect-it seems to help our students focus on the fundamentals in ways that simulations involv­ ing only law students do not. that is, we find that the introduction of complexity to the exercises by adding role-playing clients from other disciplines advances the acquisition of fundamental skills, rather than dis­ tracting from them . . . . we believe that adding the cross-disciplinary dimension to our simulation exer­ cises deepens and richens the learning experience and also helps the students more effectively envision themselves as professionals. 103 c. pro bono activities extracurricular activities can also foster many core professional values and professionalism traits identified by the macerate and carnegie reports, including the development of professional identity, leadership skills, and commitment to community betterment and pro bono service. faculty can play a role in visibly encouraging students to engage in pro bono activities in their community and by helping to facilitate community connections where the faculty may already have contacts. in my experience, the current generation of law students is highly motivated to give back to their commu­ nities, and all it takes is pointing them in a productive direction related to i 01. students try moot case with medical residents, supra note 97. 102. id 103. c. k. gunsalus & j. steven beckett, playing doctor, playing lawyer: interdisci­ plinary simulations, 14 clin. l. rev. 439,441-42,445 (2008). 448 indiana health law review [vol. 9:2 the legal field they are intere~ted in. for example, our student health law association (shla) engages in a mentoring program for atlanta high-school students at carver high school, which has a focused program for students interested in health sci­ ences and research. for the past two years, shla members and carver students have participated in a program called journey through justice, a mock trial program for high school students developed by the state bar of georgia. reflecting on the value of pro bono service for developing profes­ sional values in law students, one law student said: "the law students get as much from the [mentoring] program as do the high school students."104 our health law students also volunteer .in other community activities that are related to health promotion and support health-related non-profit organizations, such as fun runs, 105 fund-raising, 106 ·and blood drives.107 ·when our health law faculty were considering a proposal for a new certifi­ cate in health law at the law school, the student reviewers felt so strongly that such activities supported the core professional values competencies identified in the proposal that they advocated for making participation in extracurricular activities mandatory in order to receive the certificate. xiii. collaborating witii national :sar and professional associations most legal disciplines have professional associations and societies that promote the interests of their membership, usually practicing attorneys. in the health law field, two of the largest are the american health lawyers association. and the american bar association's health law section. classroom professors may prefer to engage with academic associations and not feel the need personally to engage with such professional societies. they can easily recommend them to their students, however. . these organizations have many resources that can be valuable to stu­ dents in developing their skills and professionalism. these resources in­ clude opportunities for g8ining substantive legal knowledge, such as 104. students mentor carver high school students, ga. st. unn. coll. law (feb. 4, 2011), http://law.gsu.edu/clhs/6606.html?id=525. see also taking carver high school stu­ dents on a journey, ga. st. unn. coll. law (nov. 11, 2011), http://law.gsu.edu/ clhs/7448.html?id=580. 105. see, e.g., shla cheers on runners at children's fun run, ga. st. unn. coll. law (oct. 7, 2011), http://law.gsu.edu/clhs/7434.html?id=572. 106. see, e.g., students hold benefit to aid ugandan children, cir. for law, health & soc'y newsl. (ga. st. univ. coli. law, atlanta, ga.), fall 2008, at 5, available at http://law.gsu.edu/clhslpdf/newsletters/fall_ 2008 _ newsletter.pdf ("[the student-held bene­ fit supporting the education of children in uganda is] a great example of taking classroom learning and applying it to help make an impact here and abroad."). 107. see, e.g.; students kick-off shla co-sponsored blood drive by discussing the fda ban on all sexually active gay donors, ga. sr. unn. coll. law (feb. 9, 2012), http://law.gsu.edu/clhs/7630.html. 2012] developing skills and values in law teaching 449 through podcasts, webinars, conferences, and journals. they also represent opportunities for students to develop lawyering skills, such as through writ­ ing competitions and writing short articles for the organization's publica­ tions. these associations also offer opportunities to network and develop professional connections. i serve on the governing council of the aba health law section, and we have made efforts over the years to reach out to law students in the cities where our annual conference is to take place and to invite them to parts of the conference free of charge (or at substan­ tially discounted rates), as well as to receptions. the section also responds to student requests for attorney speakers in their locale on topics of student interest. partnering with these national societies can also create unexpected projects that can develop the skills and qualities of the successful practicing professional. for example, a current law student and i collaborate~ for over eight months with the staff of the aba to completely revamp the health law section's student membership website to make it more accessible to (and more accessed by) law students across the country.108 while not a tra­ ditional assignment, this law student learned valuable professional lessons like how to work with staff, ask the right questions, not assume that some­ one else has all the answers, think creatively and strategically, lead confer­ ence call discussions, engage in drafting and editing, clarify understanding both orally and in writing, move a project forward, be persistent as well as flexible (especially when the project takes so much more time than one thought it would at the outset), and be gracious and positive even if frustrat­ ed or overwhelmed. these are real-world skills and qualities that, while not usually developed in the classroom or through more traditional research projects, will stand her in good stead in professional practice. it is relatively easy to connect law students to national bar associations (as well as to state and local bar associations). all it takes is the willingness to think outside the classroom, peruse the websites to learn about their re­ sources, and pick up the phone. the professional societies are very inter­ ested in working with law students, who represent their future membership. xiv. partnerships with the local practicing bar a. one-time opportunities for students even if you are not admitted to practice in the state where you teach, you might still consider joining your state or local bar association for the 108. see generally welcome law students, am. bar ass'n, http://www.american bar.org/groups/health _law/membership/law_ students_ welcome.html (last visited may 8, 2012) (launched feb. 3, 2012). 450 indiana health law review [vol. 9:2 professional connections you could make for yourself and for your students. bar and other professional associations often allow faculty a courtesy membership (if willing to pay dues). for example, i am a member of the georgia hospital association, and thereby of the georgia academy of healthcare attorneys, even though i am not employed by or representing a hospital.109 the professional relationships you develop with local practicing attor­ neys can inure to your benefit, both in opportunities to find guest speakers for your classroom as well as for collaboration in scholarship. for your students, your connections to the bar can offer any number of serendipitous opportunities to learn the skills and values of professional practice. some­ times attorneys need some quick help on a one-time project, like a cle presentation or bar journal article. these opportunities may or may not be for pay and may or may not tum into future employment opportunities, but they do offer a short-term immersion in professional work. atlanta attorneys have reached out to me to inquire whether i knew a student who could help them out on such a project, and i have always been happy to oblige. beyond developing the research and writing skills that students typically use in such projects, there can be significant benefits in developing professional qualities and traits. students learn adaptability ("i need this yesterday"), independence and problem-solving ("here's what i ·want to know-~-can you figure it out?"), how to ask the right questions (ap­ . preciative inquiry and active listening), and persistence (to keep the project . within the deadline). they also get a glimpse into professional culture (domain knowledge), which can be missing from the academic classroom. such experiences can also build self-confidence and professionalism. one of my students recently helped an attorney on a cle presentation. when the work was done, the attorney's firm paid for the student's admis. sion to the conference. the. attorney openly gave the student credit for her work, and the audience gave her a big round of applause. rubbing shoul­ ders with. practicing attorneys, who came up to congratulate the student at the break, may have been as important to this student on her road to devel­ ophtg as a professional. as the research and writing skills she honed. and all it took was a telephone call to get the ball rolling. 109. i am a member of the state bar of georgia, with a license to practice in georgia, although i do notpractice. in the 1990s, i was part ofthe original group of attorneys who established the health law section of the bar, and served in various capacities over the years, including chair of the section. . although i am not as active in the section as i once . was, the professional relationships that i established through such bar work both have en­ riched my teaching and research and have occasionally offered opportunities for my students to "get a foot in the door." 2012] developjng skills and values ln law teachjng 451 b. setting up recurring opportunities the loyola university chicago health law faculty has also hosted a saturday morning workshop with respected chicago attorneys, which fo­ cuses on the analysis of a transactional case study from the attorneys' own practice.110 a collaborative workshop between students and the practicing bar not only enhances analytical skills, it also gives students insight into the mindsets of problem-solving attorneys and an appreciation of how the cul­ ture and features of a particular industry can impact the way clients are counseled. the workshop was so popular that it became an annual event. 111 setting up this kind of recurring opportunity for students outside the classroom does take both advance organizational time and the time to im­ plement it. if undertaken on a yearly basis, however, the start-up costs are minimized with each successive year, while the benefits fully accrue for each new crop of students. among these benefits is the development of professional identity that comes with working directly on a real case with respected practitioners. c. mentoring programs just as students enjoy out-of-classroom connections with their faculty, they also want to build relationships with practicing attorneys who can mentor them. what does mentoring offer? with respect to domain knowledge, student mentees begin to become acculturated to the legal pro­ fession and how real lawyers think (about their work, careers, clients, col­ leagues, work-family balance, and other aspects of professional life). good mentors model the good habits of successful practice, including ways of dressing, conversing, respecting boundaries, prioritizing time, and keeping commitments. through mentoring, students can develop their professional identity and learn professional values. mentoring programs can be formal or informal. the most formal is the american inns of court, whose mission "is to foster excellence in pro­ fessionalism, ethics, civility, and legal skills."112 gaining momentum since the 1980s, this national organization adapts the english model of appren­ ticeship. there are four membership groups in each inn: masters of the bench (law professors, judges, and experienced lawyers); barristers (less experienced lawyers than masters); associates (less experienced lawyers than barristers); and pupils (law students).113 with about 80 members, an 110. singer & bess, supra note 91, at 855. 111. jd. 112. am. inns of court found., creating an american inn of court iii (2008), available at http://www.innsofcourt.org/content/default.aspx?id=s (search "creating an inn of court;" then follow hyperlink under "creating an inn of court booklet"). 113. ld. at 2. 452 indiana health law review [vol. 9:2 inn divides into "pupillage teams" with a few members from each catego­ ry.114 from september to may, each team is responsible for planning one of the inn's monthly programs, which generally includes an opportunity to "break bread" as a group and discuss a topic on ethics, professionalism, and legal practice.115 law students and newer attorneys are mentored through this exchange of ideas and experiences with more senior practitioners.116 the goal of such mentoring is to foster the ideals of civility, ethics, and pro­ fessionalism.117 any law school can create one or more inns of court. traditionally, the orientation of such inns has been on civil or criminal litigation practice. this is changing, and there are now inns specializing in administrative law, environmental law, family law, intellectual property law, labor and em­ ployment law, pro bono, tax law, transactional law, and other legal fields. 118 while there is not yet a health law inn of court, there is no reason you could not establish one at your law school. at georgia state, we are cur­ rently exploring with the national organization whether we can set up an interdisciplinary inn of court related to health law. less formally, you can establish a mentoring network among your graduates who work in health law and your students who are interested in health law. your students may well be motivated to help with the organiza­ tional process. our student health law association has set up social events to entice our graduates to get involved in the mentoring program.119 at the very least, you can pair one student you know with one graduate you know-presto, a mentoring program. xv. conclusion this article has offered a continuum of opportunities for developing students' lawyering skills and professional values and attributes in real­ world contexts. they vary in complexity and the amount of a professor's time and attention needed to accomplish it. "but most of these innovations will take too much time," some law professors may object, who are worried about their scholarship and service obligations. true, it does take time to collaborate and to alter one's teach­ ing approach, but how much time really depends on you. it can take an hour, a day, a week, a semester, or a couple of decades to implement some of these innovations described above. if you are enthused about a prospec114. /d. 115. id. 116. /d. 117. /datl. ll8. id. at 4. 119. see, e.g., shla hosts mentor-mentee maer, ga. st. univ. coll. law (nov. 28, 2011 ), http://law.gsu.edu/clhs/7454.html?id=583. 2012] developing sk.ll..ls and values in law teaching 453 tive collaboration but worried that it will adversely impact your other re­ sponsibilities, talk to your administration and strategize about how to mini­ mize the conflict. there may be incentives and accommodations (e.g., course release, committee release, summer grant for teaching improvement that "counts" for promotion and tenure, etc.) which deans may be willing to make-at least, those deans who are listening to the on-going calls for legal education reform. those deans may even be gratified when they learn about your interest in innovative teaching and your responsiveness to car­ negie concerns. "but i can't afford to sacrifice the doctrinal coverage in my class," others may object. actually, you can. the good news is that doctrinal knowledge is diminishing in importance for legal employers while our stu­ dents' competency in skills and other professional qualities is increasing in importance.120 when our health law faculty convened a group of highly respected health law attorneys in atlanta to advise us as we considered revi­ sions to our health law curriculum, the attorneys uniformly and repeatedly encouraged us to offer more skills opportunities. swprisingly (to us), they were so concerned about our fostering the skills and values competencies of good lawyers that it was hard to get them to focus on the knowledge com­ petencies in health law that we had worked so hard to identify and come to consensus on. the emphasis of potential employers on our students' skill sets beyond doctrinal knowledge and. case-based legal analysis should feel liberating for classroom professors. while it may take time away from doc­ trinal coverage, shifting to more collaborative and real-world learning will not impair the students' education. rather, it will enrich it and make it more relevant to their professional lives. this article has taken an expansive view of the "real world." the real world consists of real people who engage in or are impacted by the laws we are teaching our students. the real world of health law is situated in differ­ ent settings (corporate, law frrm, non-profit, government, advocacy, policy, laboratory, etc.) and in different disciplines (public health, bioethics, medi­ cal, nursing, business, life sciences, etc.). an experience counts as "real world" if it exposes students to models of working and being in the profes­ sional world. collaborating with real-world professionals from legal and other disciplines that lawyers routinely work with, even in a classroom sim120. the diminishing importance of specific technical knowledge and skills for entry­ level positions is true across employment settings. daniel goleman has written generally about "emotional intelligence" being more important to career success than technical skills and knowledge. he reports that the qualities employers want in their new hires are the abil­ ity to learn on the job; listening and oral communication; adaptability and creative responses to setbacks and obstacles; personal management, confidence, and motivation; group and interpersonal effectiveness, including teamwork and ability to negotiate conflicts; and organ­ izational effectiveness and leadership. only one of the seven desired employee traits was academic: competence in reading. writing, and math. daniel goleman, working with emotional intelligence 12-13 (1998). 454 indiana health law review [vol. 9:2 ulation, can help to place the topics in context. such context-based learning helps students integrate understanding the legal subject matter with devel­ oping other skills and values. at a minimum, real-world collaborations can mix up the law class­ room routine and get students' attention, a first step in improving their learning. 121 when students see real problems or real people, their motiva­ tion to engage with them constructively is significantly enhanced.122 real­ world collaborations also offer authentic learning opportunities, which can deepen learning and make it lasting.123 students are not the only ones who benefit from such collaborations: they can promote your own professional engagement and development and may even further your law school's mis­ sion. 124 aside from all these benefits, i encourage you to consider incorpo­ rating real-world collaboration in your teaching just for the sheer fun of it. 121. see scott, supra note 82. 122. gunsalus & beckett, supra note 103, at 462 (observing that "(m]otivation is a central element of learning ... and the research shows that '[!]earners of all ages are more motivated when they can see the usefulness of what they are learning and when they can use that information to do something that has an impact on others."' (quoting comm. on devs. in the sci. of learning, nat'l research council, how people learn: brain, mind, experience, and school 49 (john d. bransford et al., eds., 1999))). 123. see melissa manwaring, bobbi mcadoo & sandra cheldelin, orientation and disorientation: two approaches to designing "authentic" negotiation learning activities, 31 hamline j. pub. l. & pol'y 483, 485, 498 (2010) ('"[a)uthentic activities' -or learning activities that re-create as closely as possible the context (key dynamics, challenges, emo­ tions, etc.) of real-world activities-are critical to making learning relevant and transfera­ ble," and advocate for increased educational use of "adventure learning" activities, which "typically comprise direct, active, authentic, engaging, and collaborative experiences that take place outside traditional classroom settings, involve some element of real or perceived risk, and involve the whole person (not just the cognitive)."). 124. for example, elizabeth pendo observed that through working with her students on their service-learning project, she deepened her own knowledge about an area of law and formed community relationships that resulted in the formation of a disability issues working group in st. louis. pendo, supra note 50, at 157. the project was also consistent with the law school's public service mission, ''which includes the expectation that our graduates will be 'legal professionals who use their knowledge to serve others.'" /d. at 154. ihlr vol 14 iss. 2.pdf http://doi.org/10.18060/3911.0040 https://doi.org/10.1111/cts.12255 https://doi.org/10.1001/jama.2015.7691 http://doi.org/10.1200/jco.2014.60.6004 marshall b. kapp marshall b. kapp was educated at johns hopkins university (b.a.), george washington university law school (j.d. with honors), and har­ vard university school of public health (m.p.h.). he is the director of the florida state university center for innovative collaboration in medicine and law, with faculty appointments as professor, department of geriatrics, fsu college of medicine, and professor of medicine and law in the fsu college of law. he also is affiliated with the fsu pepper institute on ag­ ing and public policy. he is editor emeritus of the journal of legal medi­ cine, a fellow of the gerontological society of america and the american college of legal medicine, and a recipient of gsa's kent award. a collaborative center in medicine and law: lessons from a disruptive innovation marshall b. kapp • i. introduction ............................................................................... 457 ii. developing a portfolio ............................................................ 458 a. basic principles ........................................................................ 458 b. examples of projects ................................................................. 460 1. polst ................................................................................. 460 2. the humanizing risk management education project ...... 462 3. summer student projects .................................................... 464 4. florida health policy center ............................................. 465 ill. lessons learned/challenges remaining .............................. 467 n. conclusion .................................................................................. 470 i. introduction when i arrived at florida state university in 2010 to launch a new ac­ ademic enterprise, i inherited a name for that .undertaking that encapsulated the vision of the planning committee-the center for innovative collabora­ tion in medicine and law (the ''medicine-law center''). this name has engendered many comments. observers have expressed a mixture of curi­ osity and admiration regarding the center's stated mission.1 a number of people have suggested that the medicine-law center's title may be redun­ dant since, given the sorry history of pervasive tension generally found be­ tween medical and legal professionals in the united states/ any sort of * director, florida state university center for innovative collaboration in medicine & law; professor, fsu college of medicine department of geriatrics; professor of medicine and law, fsu college of law. l l11,11yjdzictcry p:qg(/or( ~./ott~ ~ m medicine 4ntif-aw, fla. state tj'nlv: col£. ot mw·· bttp:/tmed.fstt~~ollaboration.home (last~~ 15, 2().2) ~ meclicine-y.w.' qent«~s .idissi9tj· ~~:identify 81)4f@ilitate (tbro\lgh wucati~ :the c;qjducf lli1d di~.ti9jl·{>fscbd~·arid }'jelf~ee of ser­ vice activities) :o~if:ies. f'ot ~ ot' the ~calatsd lepj f)n>fessioj18, fworking togelbetq.nd;w{tjt~·:to~·~·lit·ihequaliijt offi~eaj!lyecjby:~yiduals and't()pl'olliotejnlblk heaj.ti.m flo'ijtta, ..,. · · ~ aa4 j .. y; ~center ~tores educationat,~md)~avenoes: ...•.•.. · ·~:am!~~ the medical andteglilprofessiimsiqn belialfof:tb!' ~.,being of~ who are ixlth physicians'·pati~ts81:td atto~· ~-~"">~ · · · · · · 2. regarding that histoty of pervasive interprofessional tension, see, e.g., marshall b. kapp, our hands are tied: legal tensions and medical ennes (1998); allen ka­ chalia et al., physician responses to the malpractice crisis: from defense to offense, 33 j. l. med. & ennes 416 (2005); robert a. burt, doctors vs. lawyers: the perils of perfec­ tionism, 53 st. louis u. l.j. 1177 (2009).· 458 indiana health law review [vol. 9:2 collaboration the medicine-law center might facilitate between medicine and law would have to be "innovative." with a few notable exceptions,3 those who have quipped about the medicine-law center's official name are correct that successful medical­ legal collaborations have not been abundant. in a quest to change that situa­ tion, the medicine-law center has since its inception tried to operationalize its mission by slowly developing, on a trial-and-error basis, a portfolio of activities with real world connotations that is intended to capitalize on po­ tential areas of shared interests and values between physicians and attor­ neys. the next section briefly describes a sample of the medicine-law center's early activities helping to give tangible form to its planners' vi­ sion. the ensuing section discusses key lessons learned and challenges to be overcome by academic centers in their quest to exert a positive impact on actual people. ii. developing a portfouo moving from ideas to action in the progression of an academic center requires development of a portfolio of tangible activities that are both con­ sistent with the center's mission and financially feasible to implement. the development of such a portfolio for the medicine-law center over the first couple of years of its life has been guided by several basic principles. a. basic principles first, in keeping with the medicine-law center's title and mission, any teaching, scholarly, or service activities undertaken obviously must be interprofessional in nature. "interdisciplinary" or "interprofessional" collabora­ tions involve members of different professions who work together on a problem ''with intention, mutual respect, and commitment." the process "facilitates the achievement of goals that cannot be reached when individual professionals act on their own." collabora3. the most notable exception is the medical-legal partnership (mlp) movement, embodied in more than ninety collaborative programs. the mlp idea in both theory and practice has been well-chronicled elsewhere. ·eljzabe111 tobin tyler et. al., poverty, heal1h and law: readings and cases for medical-legal par1nership (2011), re­ viewed in marshall b. k.app, medical problems, legal responses, 40 j.l. med. & e1hics (2012). florida state university's mlp program, which brings together students and faculty from the college of law and college of medicine in the context of a neighborhood health clinic, is described at public interest law center, fla. state coll. of law, http:/naw.fsu.edulacademic_programs/jd_program/ca.c/index.html (last visited may 17, 2012). 2012] collaborative center in medicine and law tion consists of the following. elements: a common purpose, separate professional contributions, and a process of cooperative joint thinking and communica­ tion. ultimately, "[a ]n interprofessional approach does not blur the distinctiveness of each profession, but it does break through the extreme role specializa­ tion that fails to appreciate the kind of balance and in­ tegration that a holistic orientation requires.',.. 459 thus, an interprofessional focus goes beyond merely multidisciplinary exercises (although they may be very important in their own right), which consist of gathering members of different professions around the same table and having them each represent their respective, differing perspectives dur­ ing the discussion. second, while different particular projects are likely to concentrate on a single leg, or at inost a combination of two legs,5 of the tripartite academic stool of teaching, scholarship, and service, the medicine-law center's port­ folio as a whole strives for a balance of all of these kinds of activity. the realm of service is interpreted broadly, to include the university, society (including particular patients/clients), and the respective relevant profes­ sions as potential beneficiaries. third, specific projects fall into one or the other of two categories of project ownership. some projects are owned by the medicine-law center itself, in the sense of the center functioning as the main player in originat­ ing the idea of, obtaining funding for, and conducting, managing, and dis­ seminating results of the project, while involving affiliated faculty6 and others as collaborators. by contrast, there are projects that are initiated and owned by other faculty (individually or in groups) or professional or com­ munity organizations for which medicine-law center involvement in some form is invited. growing this latter portion of the portfolio depends upon the medicine-law center methodically enhancing its profile within the uni­ versity and community as a valuable repository of expertise and a useful resource to be tapped for synergistic collaboration. 4. linda morton et al., teaching interdisciplinary collaboration: theory, practice, and assessment, 13 qulnnipiac health l.j. 175, 176-77 (201 0)( citing gary l. harbaugh, assumptions of interprofessional collaboration: interrelatedness and wholeness, in r. michael casto & maria c. juua, lnterprofessional care .and collaborative practice 20 (1994)). 5. service learning initiatives fall into this category. see susan r. jones & shirley j. jones. innovative approaches to public service through institutionalized action research: reflections from law and social work. 33 u. ark. lrm.e rock l. rev. 377, 387-91 (2011). 6. the center for innovative collaboration in medicine & law has put into place a structure of faculty associates and affiliates. see faculty and affiliates, fla. state univ. coll. of med., http://med.fsu.edu/index.cfm?page=innovativecollaboration.faculty affili· ates (last visited may 15, 2012). 460 indiana health law review [vol. 9:2 b. examples of 'projects a small sample of projects undertaken or contemplated by the medi­ cine-law center is briefly described. these projects illustrate the medi­ cine-law center's mission in action. 1. polst every state has enacted laws intended to help critically ill medical pa­ tients maintain a degree of personal autonomy or self-determination regard­ ing decisions about the initiation, continuation, withholding, or withdrawal of various medical interventions, even at a time when the patient lacks suf­ ficient cognitive or emotional capacity to rationally make and communicate his or her own choices. however, experience with advance directives over the last couple of decades has led to the identification of significant prob­ lems. 7 the most salient of these include: the reluctance of many people to use the available legal tools in a timely fashion; the paucity of practical guidance, or confusing guidance, provided by advance directive forms for patients filling them out and medical professionals trying to apply them in clinical scenarios; patients' goals and preferences often changing over time; the frequent ignorance of the health care agent regarding the real care pref­ erences of the patient; and the fact ·that, even when providers know that an advance directive exists (and such knowledge cannot always be assumed), the advance directive frequently does not alter the patient's course of treat­ ment8 or may even exacerbate the clinical situation.9 growing frustration with the inherent limitations of existing instru­ ments for promoting the prospective autonomy of critically ill patients who become decisionally incapacitated has led many attorneys, 10 health care providers, and commentators to advocate as the next step in the evolution of health care advance planning law the use of polst (physician orders for life-sustaining treatment)11 forms. unlike a traditional advance directive executed by a patient while still decisionally capable, polst entails a med­ ical order written by a physician (with the concurrence of the patient or sur7. see dorothy d. nachman. living wills: is it time to pull the plug? 18 j. elder l. 289,299-301 (2011). 8. see charles p. sabatino, the evolution of health care advance planning law and policy, 88 milbank q. 211, 221-24 (2010); keith e. sonderling, polst: a cure for the common advance directive-it's just what the doctor ordered, 33 nova l. rev. 451, 470-76 (2009). 9. lesley s. castillo et. al., lost in translation: the unintended consequences of advance directive law on clinical care, 154 .annals intern. men. 121 (2011). 10. see, e.g., kathryn tucker, elder law: counseling clients who are terminally ill, 37 wm. mitchell l. rev. 117, 124-25 (2010). 11. some states vary the terminology slightly, e.g., molst (medical order for life sustaining treatment), post (physician order for scope of treatment), most (medical order for scope oftreatment), or colst (clinical order for life-sustaining treatment). 2012] collaborative center in medicine and law 461 rogate) instructing other health care providers, such as emergency medical squads, about the treatment of the critically ill patient under specific factual situations. approximately fourteen states have formally implemented the polst paradigm. 12 many more states are in the process of developing their own versions ofpolst.13 there is an array of legal impediments to successful adoption and ful­ fillment of the polst paradigm. 14 in florida, an informal working group of interested attorneys, health care and human services providers, profes­ sional associations, and academics has come together under the coordinat­ ing umbrella of the medicine-law center to identify and explore possible strategies for pushing forward acceptance and implementation of the polst paradigm in this jurisdiction. this is an excellent mission-driven project for the medicine-law center because, generally, the medical and legal professions concur in principle that patients in end-of-life situations ought to have their treatment preferences honored and that the law should facilitate, rather than impede, policy and practice designed to effectuate the · ethical obligation to promote patient autonomy in this context. getting the · polst paradigm implemented in policy and practice in florida will re­ quire the active collaboration of the medical and legal professions (along with other interest groups with special experience and expertise), and the expected result of that collaboration will enhance public (including pa­ tients' /clients' and their families') well-being. one component of the medicine-law center's polst paradigm ini­ tiative was the sponsorship of a summer 2011 research project done collab­ oratively by a medical student and a law student. under medicine-law center supervision, these florida state university students worked together to research and review relevant medical, legal, ethical, and policy literature on polst and to jointly conduct conversations with a convenience sample of family members who had recently personally lived through end-of-life scenarios with loved ones, as well as conversations with several practicing physicians, other· health care professionals, and attorneys. besides greatly benefitting the two involved students educationally, this project produced a poster presentation that educated attendees of both the florida medical as­ sociation's 2011 annual meeting15 and the florida medical directors 2011 12. physician orders for life-sustaining treatment paradigm, polst, http://www.ohsu.edu/polst (last visited may 15, 2012). · 13. charles p. sabatino & naomi karp, improving advance illness care: the evolution of state polst programs, no. 2011-01 (2011), available at http://assets.aarp.org/rgcenter/ppi/cons-prot/polst -report-04-11.pdf. 14. susan e. hickman et. al., the polst (physician orders for life-sustaining treatment) paradigm to improve end-of-life care: potential state legal barriers to im­ plementation, 36 j.l. men. & ennes 119, 119 (2008). 15. brittany lamb & sarah catherine spillers, is the polstmodel desirable for florida?, poster presented at the annual meeting of the florida medical association, or­ lando, fla. (july 28, 2011 ). 462 indiana health law review [vol. 9:2 annual meeting, 16 in addition to a published paper that will support the center's polst advocacy efforts.17 2. the humanizing risk management education project another center project has revolved around the fact that medical stu­ dents hear a lot about the law, but unfortunately very little of what they hear is told to them by knowledgeable attorneys. instead, throughout the course oftheir medical education, future physicians are exposed to comments from their physician faculty mentors about the legal risks they are likely to en­ counter in their professional lives. these comments may engender legal apprehensions among medical students and may be accompanied by advice from faculty _that tends to encourage future clinical behavior inconsistent with the best humanistic care of patients. the frequently destructive rela­ tionship between physicians' negative perceptions of their legal climate, on one hand, and the humanistic character of the patient care that ought to be provided by physicians, on the other, has long been acknowledged.18 the fifteen-month (october 1, 2010 through december 31, 2011) humanizing risk management education project sought to develop, demonstrate, and evaluate one strategy for improving the education of med­ ical students regarding the relationship between legal risk management and humanistic patient care.19 "the centerpiece of this strategy ... consists of a· series of educational interventions with the ... college of medicine's ... clinical faculty members who are the primary source of medical student perceptions about the legal environment within which those students will later practice as physicians.'.w the educational intervention in this project utilized the mechanism of college of medicine faculty development program21 to plan and conduct a 16. brittany lamb & sarah catherine spillers. is the polst model desirable for florida?, poster presented at the annual meeting of the florida medical directors associa­ tion, lake buena vista, fla. (oct. 21, 2011 ). 17. sarah catherine spillers & brittany lamb, is the polst desirable for florida?, 8 fla. pub. healmrev. 80 (2011). 18. see, e.g., brenda e. sirovich, steven woloshin, & lisa m. schwartz, too little? too much? primary care physicians' views on us health care, 171 arch. intern. med. 1582, 1583 (2011) ("almost half(42%) ofus primary care physicians believed that patients within their own practice were receiving too much medical care .... more than one-quarter (28%) said they themselves were practicing more aggressively (i.e., ordering more tests and referrals) than they would ideally like to be." regarding the major factors causing them to practice medicine too aggressively, 76% of surveyed physicians identified malpractice con­ cerns in the top three.). 19. this project was supported by a grant from the arnold p. gold found., http://humanism-in-medicine.org (last visited may 17, 2012). 20. much of this project's description is taken from marshall b. kapp et al., teaching medical students how to reconcile law and ethics in practice: a faculty development model, 21 annals healm l. 271,272-73 (2012). 21. office of facul'iy dev., fla. state univ. coll. of med., www.med.fsu.edu/ 2012] collaborative center in medicine and law 463 two-hour faculty development educational session at each of the six college of medicine regional campuses. 22 these educational sessions were devot­ ed initially to reviewing years 3 and 4 students' exposure to information from clerkship faculty regarding physicians' legal risks and their manage­ ment. the sessions then explored and emphasized strategies for clerkship faculty to use in providing students with accurate information in this arena in a manner that encourages future physician behavior consistent with pa­ tient-centered,23 humanistic medicine. it was hypothesized that, as a result, clerkship faculty would be better able to teach students to practice human­ istic risk management. following a brief introduction (largely didactic but eliciting some au­ dience comments) by the author describing the project's background, hy­ potheses, and anticipated outcomes, the bulk of each workshop was devoted to a facilitated group discussion of hypothetical cases prepared for this pro­ ject. the cases were designed specifically to highlight potential tensions between physicians' legal risk management concerns, on the one hand, and the practice of good ethical clinical medicine, on the other. during the last several minutes of each workshop, participants were asked to collectively reflect upon the case discussions that had just unfolded. they were asked to do so with an eye toward formulating specific strategies or guidelines they could implement in teaching medical students about ways to effective­ ly reconcile the perceived potential tensions between their apprehensions about potential litigation and legal liability (and the consequent imperative to practice defensively), on the one hand, and the ethical (as well as legal) imperative to provide ethically and clinically sound patient care, on the oth­ er. among the most consistent of the strategies and guidelines enunciated, and endorsed by consensus, through this process were the following: • i will try to describe explicitly my thought processes involv­ ing legal and ethical considerations when students are present. • i will teach the student that ethics, common sense, and fo­ cusing on proper care of the patient are the best guides for managing legal risks. • i will be mindful of the signals i send to the student and will be more open and candid in discussions about taking the best ethical care of my patients. • i will spend time elaborating to the student the need to communicate with patients and to document what we are doing and why we are doing it. facultydevelopment (last visited may 15, 2012). 22. fla. state univ. coll. of med., www.med.fsu.edu/regional. 23. educating and developing future physicians who will "practice patient-centered health care" is a key component of the mission statement of the florida state university college of medicine, fla. state univ. coll. of med., college of medicine overview, http://med.fsu.edu/index.cfm?page=comaboutus.overview (last visited may 15, 2012). 464 indiana health law review [vol. 9:2 • i will explain explicitly to the student the legal and ethical implications of patient care recommendations and the resulting acceptance or refusal of that care by the patient • i will challenge the student to evaluate situations that might entail ethical and legal issues or ramifications. this project was a pilot attempt. in future, expanded projects building on the insights gained through this pilot, follow-up activities will attempt to evaluate the effectiveness of the faculty development workshops in improv­ ing the quality of teaching delivered by participating faculty physicians and the quality of learning reaped by medical students. more particularly, the project managers will try to assess whether, as a consequence (at least in part) of this type of educational intervention, clerkship faculty are more likely to signal to their students affirmative messages about the ability of physicians to successfully reconcile ethical obligations, precepts of good evidence-based clinical care, and their own legal risk-management interests. in other words, we will ask whether faculty can convey to students an ethos of positive rather than negative defensive medicine. this project implicates opportunities for the sort of interprofessional collaboration that is relevant to both the teaching and research legs of the academic stool. a substantial public service component also comes into play because the ultimate objective of these faculty development workshops is to enhance the quality of medical care received ten and twenty years from now by the future patients of the students who are presently being accultur­ ated into the medical profession by the faculty mentors who participated in these workshops. 3. summer student projects one 2011 summer student project comprising collaboration between a medical student and a law student was described above in the context of the larger polst paradigm effort.24 in the summer of2010, the medicine-law center leveraged funds available through the college of medicine's de­ partment of geriatrics to sponsor a different medical student-law student research team. a noteworthy aspect of this project is that the topic did not originate with the abstract intellectual ruminations of faculty or students, but rather arose from a real world problem perceived by health care provid­ ers, as expressed to the medicine-law center director by a trade associa­ tion official representing the troubled providers .. specifically, a number of florida long-term care personnel had been expressing concern regarding the impracticality and administrative burden imposed on them by state re­ quirements pertaining to the formal declaration of death for residents of 24. see lamb & spillers, supra notes 15-17, and accompanying text. 2012] collaborative center in medicine and law 465 long-term care facilities. the medical student-law student research team surveyed available literature and applicable statutory and regulatory provi­ sions, as well as interviewed a number of practicing long-term care physi­ cians, nurses, and administrators. the interprofessional student team concluded with useful suggestions for conforming clinical practice and state policy in long-term care, and also for improving clinical practice in the sphere of death certification more generally.25 in its future sponsorship and supervision of student research projects, the center will continue to both follow the model of forced interprofessional collaboration and look to prac­ titioners and policy makers in the field for topic ideas that address actual, unresolved problems that are receiving inadequate attention from academic investigators. 4. florida health policy center one final project description will illustrate how the medicine-law center intends to pursue its mission to improve the public's quality of life. over the course of2010 and early 2011, the medicine-law center (in col­ laboration with the college of medicine's division of health affairsi6 pre­ pared various iterations of a proposal to develop a three-year business plan for creation and implementation of a florida health policy center ("fhpc") at florida state university. the goal of the fhpc would be to advance the health of floridians by providing policymakers with infor­ mation and analytical skills necessary to make knowledgeable decisions · about health policy issues. the fhpc proposed to: create and deliver a multi-part educational curriculum on the basics of health care financing and delivery, drawing on the combined expertise of physicians, other health care professionals, and attorneys; provide interprofessional technical assistance and consultation in response to specific requests; conduct periodic briefings, roundtables, and continuing· education programs in which both medical and legal perspec­ tives were represented; and (through private contracts or grants) conduct or collaborate across professions in research projects and produce reports on specific health policy topics. the targeted audiences for these activities would include florida legislators, legislative staff, candidates for legislative offices, county commissioners, cabinet officials and senior personnel in florida executive branch agencies dealing with health issues, private organ­ izations who participate in the public policy making process (for example, foundations and professional associations), the general public, and the me25. leah williams, hayley dewey, & marshall b. kapp, long-term complication: florida's death certification process and long-term care, 23 int.'l j. risk & safety med. 139 (2011). 26. see fla. state univ. coll. of med., div. of heallb affairs, http://med.fsu. edulindex.cfm?page=healthaffairs.home (last visited may 15, 2012). 466 indiana health law review [vol. 9:2 dia. through these activities, the fhpc would serve as an ongoing, inde­ pendently funded, interprofessional nqllpartisan source of education, infor­ mation, and analysis regarding health policy issues in florida. the medicine-law center would not take on the role of actively advocating for or against particular legislative or regulatory proposals or approaches; in­ stead, through its interprofessional resources, it would provide objective, unbiased informational support to equip its target audiences to make deci­ sions based on timely and sound familiarity with, and understanding of, all relevant considerations. the rationale for. creating a fhpc is that florida faces significant health care challenges, most immediately a critical budget shortfall, rising health care costs (including escalating medicaid expenditures), and there­ quirement of state compliance with the federal patient protection and af­ fordable care act ("ppaca").27 it is imperative that public policy decisions made and implemented in anticipation of, and response to, these challenges be based on timely, comprehensive, accurate information and analysis. this need is underscored by florida's legal term limit restrictions for legislators, which have the unintended consequence of endangering leg­ islators' accumulated. institutional knowledge about key health programs and policy issues. florida public policy makers currently do not have access to a reliable, objective source of information and analysis to assist them in making diffi­ cult choices regarding health programs and policies,28 and they certainly lack access to sources that take advantage of the cross-pollinated perspec­ tives of different pertinent professions. there are many organizations that participate usefully in public policy discussions regarding health issues in florida, but each of them has some particular personal stake in the outcome of the policy making process that, in reality and/or appearance, colors its objectivity and therefore the value of its information and advice to policy makers. the absence of a reliable, objective, interprofessional source of information and analysis to assist florida policy makers in making difficult choices regarding health programs and policies thus leaves an important void that the fhpc could fill. the proposal ·to create a fhpc is presently dormant, as there is unre­ solved disagreement about mundane but significant administrative and gov­ ernance details among the several private folllidations that had originally contemplated coming together fu a consortium to jointly fund this .project. 27. pub. l. no. 111-148, 124 stat. 119 (2010), amended by health care and reconcil­ iation act of2010, pub~ l. no. 111-152, 124 stat. 1029 (2010). 28. this is a national situation. commentators have noted that "state legislators, par­ ticillarly part-time legislators, have few resources for in-depth study of health issues." james colgrove et al., hpv vaccination mandates-lawmaking amid political and scientific con­ . troversy, 363 new eng. j. med. 785, 791 (2010). 2012] collaborative center in medicine and law 467 nonetheless, even if the fhpc never materializes exactly in its currently contemplated form, preparation of the proposal constituted an excellent op­ portunity for serious thinking and planning about interprofessional collabo­ ration as a strategy for educating the state's health policy makers in a manner that would benefit the public while creating multiple potential spin­ otis for scholarship and teaching ofboth law and medical students iii. lessons learned/challenges remaining the florida state university medicine-law center is a young enter­ prise, so it might be presumptuous for the author to suggest too authorita­ tively useful lessons to be drawn from the enterprise's limited experience.29 however, if mistakes are a good teacher, then i have learned a great deal over the past two years in working to build from the ground floor this new academic entity with its uncommon, indeed uncharted, mission. this espe­ cially includes lessons about recognizing challenges to be confronted in this particular kind of institution-building endeavor. first, garnering general philosophical agreement about the virtues of medical-legal collaboration among academic colleagues (selling attitudes and platitudes that cost nothing to endorse) is easy, but actually convincing faculty (particularly law faculty)30 to peak out of their busy, over­ committed, disciplinary comfort zones or silos is exceedingly difficult moving faculty from vague interest and no obligation support of the curious notion of interprofessional collaboration to a point of tangibly, affirmatively engaging in collaboration is a challenge. this journey is definitely facilitat­ ed by the development of individual, concrete projects about which one is able to ask particular faculty colleagues to collaborate in defined ways, such that those colleagues can better calculate relative opportunity costs threat­ ened and rewards offered in taking on a new, collaborative project. in the medicine-law center's earliest days, significant time was unavoidably de­ voted to general introductions, "schmoozing," and amorphous suggestions that "we all must get together and be friends because we all believe in inter­ professional collaboration." however, it was not until the medicine-law 29. law professors often travel in presumptuous company. see, e.g., joseph a. dick­ enson. understanding the socratic method in law school teaching after the carnegie foundation's educating lawyers, 31 w. new eng. l. rev. 97 n.14 (2009) (quoting profes­ sor brian leiter); pmrr.e schlag, the enchantment of reason 91 (1998). 30. see, e.g., margaret e. montoya & francisco valdes, latinaslos and the politics of knowledge production: latcrit scholarship and academic activism as social justice action, 831nd. lj. 1197, 1217 n.56 (2008) (quoting angela harris' comment "on the hurt and cra­ ziness that we are all exposed to, and sometimes contaminated by, in the seductive imperial fog of the competitive, high status, atomized silos called law schools''). but see toni m. massaro, dean's welcome, 50 ariz. l. rev. 1, 8 {2008) ("law professors today are less guild-like, less operating within an intellectual silo transparent only to lawyers than in dec­ ades past"). 468 indiana health law review [vol. 9:2 center began to generate some tangible projects of the sort discussed in the previous section that faculty colleagues could really be given an opportuni­ ty to ''put up or shut up" in terms of their personal commitment to promot­ ing activities consistent with the center's mission. second, in dealing with the outside world, we must convert the com­ mon accusation that university faculty are shielded by an "ivory tower''31 into a positive asset. as discussed above in the context of the florida health policy center that has yet to come to fruition, policy makers and the public need objective, unbiased information and advice from a source that-unlike other advisors who are trying to influence policy making in a specific direction-does not have a financial or ideological "dog in the fight.'.j2 an entity like the medicine-law center located in an academic institution is ideally situated to add value (that is, to fill a need by doing what others cannot credibly do) to problem solving by purposefully taking on an honest broker, convener, or mediator type of role. this recommendation is likely to be controversial. i have consciously and expressly eschewed pursuing a political activism or advocacy role for the academic center i have been involved in developing. in fact, many fac­ ulty members promote political activism and advocacy as a central role for academic centers to play,33 especially in the health care policy arena. this position may be correct regarding law school clinics that are created pre­ cisely for that purpose.34 outside of the legal clinic arena, though, main­ taining both the appearance and reality of financial and political disinterestedness or ivory towerism enhances the credibility of an academ­ ic center and the palatability of its work product with the broadest range of possible audience members, and thus in the long run enhances the influence the center may be able to exert over policy formulation and evaluation. third, flexibility and nimbleness within the broad confines of one's declared mission are key virtues. as louis pasteur noted, "fortune favors 31. bruce a. green. the market for bad legal scholarship: william h. simon's ex­ periment in professional regulatkm, 60 stan. l. rev. 1605, 1625 (2008) ("one's academic affiliation, without more, may actually be a liability because many assume that academics live in 'ivory towers,' removed from real-world practice.''). . 32. see generally stan bernstein et al., the empowerment of bankruptcy courts in addressing financial expert testimony, 80 am. bankr. l.j. 377, 432 (2006) ("an expert who has a 'financial dog in the fight' cannot be objective; his opinion will be swayed by his financial stake and, thus, be inherently unreliable.''). 33. see, e.g., margaret chon, remembering and repairing: the error before us, in our presence, 8 seattle j. soc. just. 643, 644 (2010) (describing an academic center's ''pillars" as "advocacy, education, and researchj. 34. margaret m. jackson & daniel m. schiffzin, preaching to the trier: why judicial understanding of law school clinics is essential to continued progress in legal educa­ tion, 17 clinicall. rev. 515,523 (2011); matthewr. krell, the ivory tower under siege: a constitutional basis for academic freedom, 21 geo. mason u. c.r. l.j. 259, 282-83 (2011). medical-legal partnerships are likely to fall into this category. see tyler et. al., supra note 3. 2012] collaborative center in medicine and law 469 the prepared mind."35 the ability to act expediently, expeditiously, and op­ portunistically when funding and collaboration opportunities arise, while at the same time maintaining consistency with one's organizational mission, is laudatory and in a competitive environment absolutely necessary. the medicine-law center is trying to have several "shovel ready" projects in a constant state of readiness in case good "fortune" chooses to favor it; at the same time, the center stays alert to new projects undertaken by others at the university that might be appropriate for glomping36 onto by the center. fourth, real world relevance requires listening sincerely to the real world experiences, complaints, frustrations, and suggestions of real world people who represent the various constituencies with which we might want to partner and whom we might choose to serve. in fashioning its portfolio of projects, the medicine-law center is trying to carefully concentrate on matters of urgency to attorneys and physicians who actually deliver profes­ sional services to client/patient populations, rather than selecting agenda issues based solely on their inherent interestingness to the potentially in­ volved faculty members. at the same time, though, an academic center is not a private consultancy shop.37 while particular projects ought to be in­ formed by the input of parties who can bring a real world perspective to the table, it is imperative that a center maintain strict control of the content, high academic standards, integrity, and product dissemination modes of its portfolio. fifth, new academic entities (especially those that are innovative and therefore disruptive of the status quo) need to be established in their forma­ tive period through the cultivation of personal, one-on-one relationships. the goal at florida state university is to establish a permanent institutional presence representing the intersection of medicine and law that will be af­ forded credibility and respect regardless of which individuals happen to be employed in any specific job by the medicine-law center at any particular moment in time. nonetheless, the people from whom such credibility and respect must be earned will, at least at first, afford it only to other particular people whom they trust, and not to the center qua center .• consequently, substantial time and other resources must be devoted at the launching of an institutional medicine-law entity to meeting individually with potential col­ laborators on the faculty and in the larger community, and selling them on a 35. wikiquote, louis pasteur. http://en.wikiquote.org/wikillouis_pasteur (last visit­ ed may 15, 2012). 36. wiktionary, glomp, http://en.wiktionary.orgfwiki/glomp (last visited may 15, 2012). (to .. glomp" is «to embrace enthusiastically; to pounce on and hug, oftenfrom a running start.") (emphasis added). the center is attempting to achieve a steady running-or at the least jogging-start in a number of areas of possible collaboration with others. 37. of course, a private, proprietary consultancy arm could be set up as a separate entity, subject to applicable university rules. cf. stephen n. dunham, government regula­ tion of higher education: the elephant in the middle of the room, 36 j.c. & u.l. 749, 764 (20 1 0) (referring to the faculty "day a week" consulting policy common in universities). 470 indiana health law review [vol. 9:2 retail, rather than wholesale, basis about the value of the center concept and particular projects being contemplated as additions to the center's activities portfolio. finally (although this list by no means purports to be comprehensive), one would be sorely remiss to fail to mention the fundamental role of mon­ ey in the "making it real" equation. a new academic center in any sphere, and certainly one hinging. on innovative interprofessional collaboration, needs to have a financial endowment to ensure not just generic survival in the modem resource deprived university environment, but growth and pros­ perity in filling an important gap on a long term basis. the leadership of such a new center probably will have to devote enormous time and effort in working closely with development personnel in building that endowment. once obtained, though, an adequate, permanent financial underpinning should enable a center to construct a teaching, scholarship, and service port­ folio true to its distinctive mission rather than being forced to continually engage in chasing any temporarily available pots of grant dollars,· whether or not the projects thus undertaken are really central to the center's an­ nounced mission. money equals freedom in many different respects, and an endowment is essential for a center to set its own course. iv. conclusion there is an important role for txaditjonal academic health law centers such as those thatalready exist at many fine law schools.3g· however, that is not the role adopted by the relatively new center for innovative collabora­ tion in medicine & law at florida state university. operationalizing with­ in an academic center an active, ongoing, synergistic interaction between the medical and legal professions is a challenge, but one whose ultimate objectives-for both the . public and members of the respective profes­ sions-are well worth the necessary investment of time, treasure, and ener­ gy. 38. see u.s. news and world report, healthcarb law-best law schools (2012), available at http://grad-schools.usnews.rankingsandreviews.comlbest-graduate­ schools/top-law-schools/clinical-healthcare-law-rankings. “and if your friends jumped off a bridge, would you do it too?”: how developmental neuroscience can inform legal regimes governing adolescents michael n. tennison* & amanda c. pustilnik** i. introduction ................................................................. 534 ii. legal regimes constraining adolescent autonomy: a typology ........................................................................ 543 a. recent supreme court holdings recognize juvenile developmental difference .............................................. 543 b. a typology of legal approaches to adolescent autonomy and responsibility ........................................ 546 1. total denials of autonomy ..................................... 546 2. delegated autonomy ............................................... 548 3. graduated autonomy .............................................. 550 4. total autonomy ....................................................... 552 5. censure-based responsibility ................................ 553 c. the result—multiple regimes lead to inconsistent outcomes ........................................................................ 555 iii. how – and why – adolescents are different ....... 556 a. the brain’s adolescence ............................................ 556 b. developmental disparity between pfc and limbic system ............................................................................. 562 c. emotional control and reactivity ............................. 563 d. reward and impulsivity ............................................ 565 iv. three cases of juvenile law analyzed via neurodevelopmental criteria ...................................... 566 a. the case of tattooing ................................................ 567 b. the case of alcohol, tobacco, and other addictive substances ...................................................................... 571 * j.d., m.a. [bioethics]. research fellow, university of maryland thurgood marshall law library. ** professor of law, university of maryland; faculty member, center for law, brain, and behavior, massachusetts general hospital. michael tennison and i are grateful to jennifer drobac and the indiana university robert h. mckinney school of law, hall center for law & health for convening this symposium. http://dx.doi.org/10.18060/3911.0002 534 indiana health law review vol. 12:2 c. intentional violence ................................................... 578 1. scenario a: vulnerable to violence ....................... 580 2. scenario b: deliberate violence ............................. 584 v. recommendations & conclusion ............................... 585 i. introduction on september 17, 2014, a teen boy riding in the front seat of an suv on the highway at night had a brilliant idea: if he set the driver’s armpit hair on fire, it might impress the girls in the back. it did not turn out quite the way he planned. “teen setting underarm hair on fire causes rollover crash,” reported news outlets the next day.1 the suv ran into a ditch, flipped over, and threw three of the five occupants—all teenagers, none of whom were wearing seat belts—out onto the highway. miraculously, no one was killed.2 this story is humorous and serious all at once. humorous, because it embodies a head-shaking truth long acknowledged in our and other cultures about the crazy things kids do. serious, because the thoughtless yet typical action of one boy could have seriously hurt or killed these four children and possibly other people on the highway that night. and it has a serious message: teens are different from adults, on average, particularly in ways that relate to the overvaluation of present rewards and sensations, the undervaluation of negative risk, the tremendous salience of their desire for peer approval, and their tendency to act in 1 deputies: teen setting armpit hair on fire causes rollover crash, khou.com (sept. 18, 2014, 5:36 am), http://www.khou.com/story/news/weird/2014/09/18/deputies-teensetting-armpit-hair-on-fire-causes-rollover-crash/15815971/. see also jason molinet, lighting driver’s armpit hair on fire caused idaho rollover crash: cops, new york daily news (sept. 17, 2014, 11:10 pm), http://www.nydailynews.com/news/national/armpit-hair-firecaused-idaho-rollover-crash-cops-article-1.1943702; ashton edwards, burned armpit hair prank ends in teens rolling suv, fox13 salt lake city (sept. 18, 2014, 12:40 pm), http://fox13now.com/2014/09/18/ burned-armpit-hair-prank-ends-in-teens-rolling-suv/. 2 see id. 2015 535 how developmental neuroscience can inform legal regimes governing adolescents even more risky and thoughtless ways when they are together in groups.3 we do not need neuroscience to tell us adolescents are different. cultures have recognized adolescent differences for a long time in a variety of ways.4 our laws already recognize that adolescents are different from adults, limiting their autonomy or modifying their responsibility in myriad ways.5 yet, we may benefit from new findings in the field of juvenile developmental neuroscience to help us understand exactly how and why teens are different from adults, and how our laws might do a better job of determining where to grant or limit autonomy and where to impose or mitigate responsibility. the ways our laws account for juvenile differences are highly inconsistent. in some areas, the law allows juveniles dramatically less autonomy than adults, but in other areas the law imposes adult-equivalent punishment and responsibility.6 contradictions between bodies of law are not in themselves necessarily problematic: different branches of law have different aims and normative underpinnings, and may balance the interests of different sets of stakeholders; accordingly, provided a body of law is internally consistent, varying or conflicting constructs across bodies of law may result from their different purposes.7 however, these contradictions do become 3 see infra part ii. 4 see, e.g., richard m. dunham & jeannie s. kidwell, rites of passage at adolescence: a ritual process paradigm, 1 j. adolescent research 139 (1986) (exploring how rites of passage facilitate the transition from adolescence to adulthood). 5 see infra part i (explaining how different legal regimes carve out different forms of treatment for minors). 6 see infra part i.b. (contrasting how the law totally denies adolescent autonomy in some areas, such as voting, but attributes full adult responsibility to other adolescent actions, such as the commission of certain crimes). 7 consider again voting in contrast with adolescent crime. the different legal treatment of minors and adults with respect to voting serves the societal interest in informed decision-making, and the law plausibly draws a bright line at the age of majority. in the case of adolescents tried as adults in criminal cases, the law serves an entirely different purpose: to punish offenders and deter potential offenders. http://dx.doi.org/10.1177/074355488612001 536 indiana health law review vol. 12:2 problematic when they arise, or are claimed to arise, from the same source. if each domain of law that governs juveniles differently from adults purports to do so based upon juveniles’ different capacities, and then those domains embody different or contradictory notions of adolescent capacities, then they are in conflict.8 the law acknowledges the liminal developmental status of adolescents in a variety of ways. the criminal law incorporates a notion of developing responsibility, providing for no criminal responsibility for infants and toddlers children, an intermediate level of sanction for young children, a higher but non-adult level of penalty for young adolescents and teens who commit less serious crimes and, often, full adult responsibility for teens who commit serious crimes.9 this criminal law approach implies a linear model of development: youth start out with little or no capacity for responsibility and gain it gradually but globally as they mature; if they engage in serious or adult-like crime, however, then they must be capable of experiencing adultlike consequences.10 in contrast to the criminal law’s linear continuum model, other areas of law afford autonomy or ascribe responsibility using an on-off toggle of age, based on a bright-line age cutoff. minors under eighteen may enter into but may electively void contracts, a regime that allows the minor to exercise autonomy but protects him or her from some of the commensurate responsibility.11 other well-known on-off “toggle” laws prohibit individuals under eighteen from voting and buying tobacco and those under 8 since, for example, voting laws and criminal laws both account for the fact that adolescents suffer from a kind of impaired decision-making by virtue of being adolescents, and yet they come to contradictory conclusions, these legal regimes are in conflict. 9 see 2 subst. crim. l. § 9.6 (2d ed.). 10 see infra part i.a. 11 see restatement (second) of contracts § 14 (1981) (“unless a statute provides otherwise, a natural person has the capacity to incur only voidable contractual duties until the beginning of the day before the person’s eighteenth birthday.”). 2015 537 how developmental neuroscience can inform legal regimes governing adolescents twenty-one from consuming alcohol.12 the patchwork of laws across the country shows lawmakers’ disagreement, ambivalence, or confusion about juvenile autonomy and responsibility, as well as about the underlying actions being regulated. thus, not only do the current legal models of adolescent decision-making capacity appear inconsistent across legal domains, they also produce apparently inconsistent results within a given legal sphere. this essay first introduces a descriptive framework that creates a typology of existing state laws relating to the regulation of adolescent autonomy and responsibility.13 we categorize existing legal approaches to juveniles as consisting of total denials of autonomy, delegated autonomy, graduated autonomy or responsibility, revocable autonomy, and total autonomy.14 this typology is necessarily imperfect because the underlying material it describes is internally muddled, resisting neat categorization. it is also imperfect because of the interplay of the concepts—and the facts—of autonomy and responsibility.15 this categorization attempt, though, reflects some genuine differences between various bodies of law and may help to show with some greater clarity the variety of approaches that the law employs when regulating adolescent autonomy and responsibility. in criminal law, there is theoretically a continuum of responsibility based on age and the harm caused—so the younger the juvenile, the less responsible.16 in reality, however, the law tends to toggle responsibility on or off based on the magnitude of harm, or, in other words, “adult time for an adult crime.”17 this emerged as part of the tough on crime movement during the 1980s that 12 see, e.g., your rights and responsibilities as a minor, tenn. comm’n on children and youth, https://www.tn.gov/assets/entities/ tccy/attachments/om-rr-14.pdf (last visited aug. 12, 2015). 13 see infra part i. 14 see infra part i.b. 15 see infra part i.b. 16 see supra note 9. 17 see david l hudson jr., adult time for adult crimes, aba journal (nov. 2, 2009) http://www.abajournal.com/magazine/ article/adult_time_for_adult_crimes/. 538 indiana health law review vol. 12:2 significantly reformed juvenile law.18 so rather than doing a close examination of whether a particular juvenile is mature to a particular degree, criminal law looks mostly at the external factor—the crime committed. if a juvenile causes serious harm, the reasoning holds that what we have is a hardened, adult-like criminal in a child’s body, not a significantly flawed, juvenile thought process, such as not understanding risk or making good risk/reward calculations.19 not understanding risk leads to the kind of bad judgment that causes you to light your friend’s armpit hair on fire while he is driving a 2000-pound suv on the highway at night. a closer look at the empirical difference between adolescents and adults could produce a more coherent paradigm of juvenile decision-making capacity and responsibility. the rapidly advancing field of developmental neuroscience has produced a wealth of knowledge that, when evaluated in relation to the interests of relevant stakeholders, could help legal scholars and lawmakers rethink areas of law pertaining to juveniles.20 responsibility entails a bundle of cognitive and social capacities that cannot be reduced to a simple continuum that runs from childhood nonresponsibility through to adult responsibility.21 juveniles do not simply become more neurologically and socially adult-like across the board as they get older. instead, different parts of the brain and various decision-making capacities develop at different rates, and frequently may not develop in a linear fashion.22 18 see, e.g., juvenile justice history, ctr. on juvenile and criminal justice, http://www.cjcj.org/education1/juvenile-justicehistory.html (last visited aug. 11, 2015). 19 see infra part ii. 20 see, e.g., jennifer h. pfeifer & sarah-jayne blakemore, adolescent social cognitive and affective neuroscience: past, present, and future, 7 social cognitive and affective neuroscience 1 (2012) (evidencing the range of neuroscientific interest in the adolescent brain). 21 see, e.g., leah h. somerville & b.j. casey, developmental neurobiology of cognitive control and motivational systems, 20 current opinion in neurobiology 236, 236 (2010). 22 see infra part ii. http://dx.doi.org/10.1093/scan/nsr099 http://dx.doi.org/10.1016/j.conb.2010.01.006 2015 539 how developmental neuroscience can inform legal regimes governing adolescents adolescents may be more prone to certain risks and influences than adults, yet display other cognitive abilities that are on average equal to those of adults.23 adolescents’ particular deficits include susceptibility to peer influence, overvaluation of emotional information, a predilection for novelty, and poor impulse control.24 on the other hand, they appear to function equivalently to adults on many cognitive tasks.25 adolescents may even outperform adults in some areas related to speed of cognitive or computational processing.26 adolescents vary from each other, just as all individuals do. certain adolescents, like certain adults, may be unusually responsible or unusually impulsive.27 different adolescents vary, too, in their degree of education, supervision, mentorship, and life experience. all of these factors contribute to whether any individual adolescent is a better or worse decision-maker. however, across the age group, the differences identified above are persistent, although in degree they may vary. these differences in capacities and 23 linda s. gottfredson, the general intelligence factor, sci. amer. presents: human intelligence 24, 29 (1998), https://www.udel.edu/educ/gottfredson/reprints/1998generalintelligencef actor.pdf (“individual iq levels tend to remain unchanged from adolescence onward, and despite strenuous efforts over the past half a century, attempts to raise g permanently through adoption or educational means have failed.”). 24 see infra part ii. 25 see gottfredson, supra note 23. 26 see, e.g., joseph j. thompson et al., over the hill at 24: persistent age-related cognitive-motor decline in reaction times in an ecologically valid video game task begins in early adulthood, 9 plos one e94215 (apr. 9, 2014), available at http://www.plosone.org/ article/fetchobject.action?uri=info:doi/10.1371/journal.pone.0094215&re presentation=pdf. 27 rhoshel k. lenroot & jay n. giedd, brain development in children and adolescents: insights from anatomical magnetic resonance imaging, 30 neurosci. & biobehavioral rev. 718, 718–29 (2006) (noting significant individual variability in development, including significant overlap in developmental trajectories between typically and psychiatrically abnormal adolescents; this work suggests that conclusions about abnormalcy versus typicality should not be made based on brain scans alone and conclusions should be reserved until relatively developmentally late in the life course). http://dx.doi.org/10.1371/journal.pone.0094215 http://dx.doi.org/10.1016/j.neubiorev.2006.06.001 540 indiana health law review vol. 12:2 abilities emerge from adolescents’ particular stage of neurological and psycho-social development, combined with adolescents’ necessarily more limited life experience.28 this mosaic of adolescent differences and similarities to adults suggests, first, that a uniform legal autonomy and responsibility discount—say, a regime that would relieve adolescents of all forms of responsibility and of personal agency, equally—would be inappropriate. it similarly suggests that the ways in which bodies of law currently modify responsibility and punishment regimes for juveniles may be inaccurately or incompletely drawn: in most areas, the law focuses on factors peculiar to the legal context, such as the importance of the right in question, like the right to bodily integrity, or the severity of the harm that the adolescent caused, as in a crime of violence.29 an emphasis on the importance of the legal right or the extent of the social harm is important, but such concerns are external to and independent of whether an adolescent has appropriate decisional capacity in that context.30 legal regimes need to consider both together: it is the combination of the features of the relevant legal context and of the particular developmental capacities and vulnerabilities that ought to shape legal regimes relating adolescents. at its worst, current law relative to adolescents is an inconsistent and internally contradictory patchwork. at its best, the law operates with an implicit idea of linear development, a continuum that suggests that juveniles mature at an even rate, gradually gaining autonomy and responsibility as they age.31 even this continuum, however, is problematic in light of how juveniles mature and the very 28 see id. 29 see, e.g., laurence steinberg, should the science of adolescent brain development inform public policy?, 28 issues 3 (2012), available at http://issues.org/28-3/steinberg/ (discussing a fact-specific analysis of juvenile responsibility in a case of felony murder). 30 see id. (contextualizing the severe effect of felony murder—the death of an innocent person—with neuroscientific evidence of adolescent impulsivity, vulnerability to peer pressure, and short sightedness). 31 see infra part i.b.3. (describing how some legal regimes, such as those governing drivers licensing, may allow for several stages of increasing autonomy as the adolescent matures). 2015 541 how developmental neuroscience can inform legal regimes governing adolescents different practical and social considerations that operate across different legal contexts.32 in the place of the patchwork and the continuum, we propose a matrix. a matrix permits lawmakers to appropriately consider the interrelationships between juvenile developmental neurobiology, the interests of other stakeholders, the institutional capacities implicated in particular legal regimes, and the relevant social norms. we suggest that lawmakers think of the relationship between juvenile neurodevelopmental factors, legal and social norms, stakeholder interests, and institutional considerations, as relating in the following way: imagine a set of juvenile capacities and vulnerabilities on one axis of a matrix. the other axes of the matrix consist of the interests of other stakeholders, the capacities of institutions, the presence of important or controlling social norms, and the signaling function of the law. like the neurodevelopmental information itself, the matrix does not determine the particular outcome. rather, it allows for clarity about the choices and trade-offs within any particular legal regime. although the matrix concept may at first appear complex, it would provide a very simple tool for lawmakers who want to generate socially and normatively appropriate yet neurobiologically informed legal regimes. even binary regimes can be compatible with this matrix concept. take for example the context of alcohol consumption: alcohol is immediately gratifying, is frequently highly socially influenced, enhances impulsivity, and creates great and harmful externalities.33 the right output from the matrix would be “no alcohol consumption until 21” (or later), an age at which the peculiar deficits of adolescence are less salient and, socially, the intense peer environments of high school and college are behind the typical young person. 32 see steinberg, supra note 29 (explaining that the adolescent brain does not simply become more adult-like as the teenager ages: intellectual maturity arrives far sooner than emotional maturity). 33 see, e.g., david j. nutt et al., drug harms in the uk: a multicriteria decision analysis, 376 lancet 1558, 1561 (2010) (ranking the harms to self and to others of common drugs of abuse). http://dx.doi.org/10.1016/s0140-6736(10)61462-6 542 indiana health law review vol. 12:2 this idea of an adolescent responsibility matrix is not meant to suggest the individualization of justice based on each adolescent’s particular maturity. such individualization—even if it were possible, which it is not— would not only be prohibitively expensive and inefficient, but would create excessive uncertainty in the law.34 an adolescent has to know, or at least be able to know, the operation of the law in advance so that he or she can plan and act appropriately.35 any fully individualized regime would require an adolescent—or any party dealing with an adolescent—to gamble in advance on what some legal maturity determination might show down the line, which would be impractical at best and dangerous at worst. this can and should inform legal notions of responsibility, and accordingly, responsibility should be conceived of in a matrix rather than a one-dimensional continuum. by matching developmentally disparate brain regions and their associated decision-making functions with various relevant areas of law, the matrix provides a higher resolution approach to specific legal situations while retaining the clarity of bright line rules for each area. part i of this paper illustrates the diversity of legal approaches to adolescent autonomy and responsibility, showing inconsistencies in the legal limitations placed on adolescents’ behaviors and the punishment for adolescents’ transgressions. part ii explores the neuroscientific state of the art with respect to adolescent brain development. part iii maps this empirical data onto a few selected cases of adolescent behaviors of interest, exploring the relationship between brain development, behavior, and existing legal regulation. part iv proposes the idea of a matrix that could help lawmakers evaluate whether or how to use neuroscientific information in conjunction with their assessments of other stakeholder and institutional 34 see, e.g., john hagan et al., ceremonial justice: crime and punishment in a loosely coupled system, 58 social forces 506, 510 (1979) (explaining the tension between judicial efficiency and individualized justice). 35 see, e.g., planned parenthood v. casey, 505 u.s. 833, 844 (1992) (explaining that liberty cannot flourish without legal stability). http://dx.doi.org/10.2307/2577603 2015 543 how developmental neuroscience can inform legal regimes governing adolescents interests, and normative and policy concerns, to create laws that are best designed to effectuate their intended purposes. ii. legal regimes constraining adolescent autonomy: a typology legal treatment of adolescence varies across and within legal domains. this creates an unintuitive and often inconsistent framework for granting autonomy and attributing legal responsibility to adolescent actions. recent supreme court opinions have turned to neuroscience to justify different punishments for juveniles than adults, for the same crimes.36 the court has held that punishing juveniles equally to adults by imposing either the death penalty or life in prison without parole for nonhomicide crimes constitutes a violation of the eight amendment’s prohibition on cruel and unusual punishment.37 although the supreme court’s jurisprudence on juvenile difference rests as much on evolving social norms as on neuroscientific findings, these recent opinions are exemplary in showing the ways in which social norms and scientific findings may interact to inform legal decision-making.38 a. recent supreme court holdings recognize juvenile developmental difference in roper v. simmons, the supreme court held that imposing capital punishment on individuals who committed crimes as minors violates the eighth amendment prohibition of cruel and unusual punishments as applied to states by the fourteenth amendment.39 in the majority 36 see infra part i.a. (discussing roper v. simmons and graham v. florida). 37 see infra note 39. 38 see infra part i.a. 39 543 u.s. 551 (2005) (overruling the prior standard that allowed for capital punishment for offenders sixteen years of age and older) (citing u.s. const. amend. viii (“excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.”)). 544 indiana health law review vol. 12:2 opinion, justice kennedy noted that constitutional jurisprudence, rooted in “history, tradition, and precedent,” must be balanced with “the evolving standards of decency that mark the progress of a maturing society.”40 kennedy looked to the prevalence of states’ rejection of the death penalty for juveniles to determine whether “our society views juveniles . . . as categorically less culpable than the average criminal,”41 and found that most states had indeed rejected such capital punishment.42 confirming this reasoning, kennedy cited empirical findings linking youth with poor decision-making, recklessness, vulnerability to peer influence, and underdeveloped character, which together preclude juveniles from having the extraordinary moral culpability required for the death penalty.43 the amicus brief from the american psychological association stated that adolescence involves increased risk-taking and an undervaluation of future consequences, undermining traditional justifications for the death penalty.44 the opinion noted that moral responsibility does not simply emerge across the board at a particular age, but that drawing a bright line at age eighteen instead of sixteen would better accommodate the vulnerabilities of juveniles and align other areas of law that recognize adulthood at age eighteen.45 picking up where roper left off, the supreme court held in graham v. florida that, for non-homicide crimes committed when the offender was a minor, the sentence of life without parole likewise violates the eighth amendment.46 as in roper, the court in graham first looked to “objective indicia of national consensus” on such 40 id. at 560-61 (citation omitted). 41 id. at 567 (citation omitted). 42 id. at 568. 43 id. at 569 (explaining that the primary purposes of capital punishment, retribution and deterrence cannot justify the death penalty for juveniles as they can for adults). 44 brief for the am. psychological ass’n, and the mo. psychological ass’n as amici curiae supporting respondent at 4-13, roper v. simmons, 543 u.s. 551 (2005) (no. 03-633), 2004 wl 1636447. 45 roper, 543 u.s. at 574. 46 560 u.s. 48, 82 (2010). 2015 545 how developmental neuroscience can inform legal regimes governing adolescents sentencing for juveniles and found a national consensus against it.47 second, the court turned to empirical evidence about the differences between juveniles and adults. this time, the court relied more explicitly on the emerging neuroscientific data amici first put before the court in roper.48 validating its reliance on sociological and scientific studies in roper, the court found that “developments in psychology and brain science continue to show fundamental differences between juvenile and adult minds,” such as a lack of fully-developed behavioral control and continuing character formation in juveniles.49 the court also argued that, excluding homicide crimes, the severity of a crime committed by a juvenile cannot on its own establish the criminal’s settled and confirmed “moral depravity” required for a punishment as harsh as life without parole.50 because of the unique vulnerabilities of juveniles, the court held that life without parole cannot be justified by any of the traditional purposes of criminal punishment—retribution, deterrence, incapacitation, and rehabilitation—and therefore the sentence constitutes cruel and unusual punishment.51 roper and graham illustrate the supreme court’s recent translations of empirical evidence, including neuroscience, into normative legal standards. such translations are not limited to the supreme court, nor are they limited to criminal law. 47 id. at 62-66. 48 id. at 68. 49 id. 50 id. at 69-70 (explaining that life without parole is “the second most severe penalty permitted by law,” one that permanently deprives the convict of liberty, like the death penalty, without regard for the possibility of moral rehabilitation). 51 id. at 71-74 (explaining that the case for retribution categorically diminishes for non-homicide crimes and for juveniles; that since juveniles are necessarily prone to rash decisions, they are unlikely—or even unable—to be deterred by harsh penalties; that juveniles are more capable of character development so they pose a lower risk of recidivism and need not be incapacitated for life; and that life without parole precludes the benefits of rehabilitation because the convict will never be allowed to reenter society). 546 indiana health law review vol. 12:2 b. a typology of legal approaches to adolescent autonomy and responsibility the law takes several approaches to differentiating the legal status of decisions made by adults from those made by juveniles. with respect to adolescents, approaches include total denials of autonomy, delegated autonomy, graduated recognition of autonomy, revocable autonomy, and total autonomy. 1. total denials of autonomy the legal category we describe as total denial of autonomy encompasses activities totally prohibited until the decision-maker reaches a certain age, often the age of majority. this means that the minor individual cannot engage in the activity, even with parental consent or under extraordinary circumstances. some total denials of autonomy are uniform across the fifty states. youth may not vote in federal elections until they reach age eighteen;52 some states and localities, however, establish a slightly lower minimum voting age for certain elections.53 in all fifty states, consistent with federal policy, persons under twenty-one may not buy alcohol.54 in all states, minors may not buy tobacco products.55 state practices vary more in other areas. in some states, minors categorically cannot get a tattoo, even with parental permission; in other states, 52 u.s. const. amend. xxvi. note that this amendment prohibits the federal or state denial of suffrage to individuals eighteen and older, but states are permitted to establish lower voting ages. 53 see, e.g., annys shin, takoma park 16-year-old savors his history-making moment at the polls, the washington post (nov. 3, 2013) http://www.washingtonpost.com/local/takoma-park-16-year-oldsavors-his-history-making-moment-at-the-polls/2013/11/03/89f00962425c-11e3-b028-de922d7a3f47_story.html. 54 see consumer information: alcohol laws by state, fed. trade comm’n (sept. 2013), https://www.consumer.ftc.gov/articles/0388alcohol-laws-state. 55 see slati overview data, am. lung ass’n, http://www.lungusa2.org/slati/slatioverview.php (last visited may 17, 2015). 2015 547 how developmental neuroscience can inform legal regimes governing adolescents parental permission allows the minor to exercise limited autonomy in this area.56 total denials of autonomy are not unique to legal regimes governing minors. the law categorically prohibits certain behaviors, even to fully competent adults. most of these prohibitions relate to preventing harm to others: we are not free to injure, to force, to take without consent.57 these prohibitions are basically other-regarding.58 a smaller category of prohibitions relates to limiting individuals’ autonomy relative to their own bodies.59 we are not free to consume illegal drugs, to sell our sexual services or parts of our bodies, or to consent to certain extreme forms of self-mutilation.60 some private sexual behaviors remain illegal, even when engaged in by the proverbial “consenting adults.”61 the theoretical justification for these limitations is murkier and certainly is not unitary. justifications for the prohibition of drug use and prostitution, for example, range from utilitarian considerations about the negative externalities of these behaviors on communities and societies, particularly the 56 see tattoo and body piercing: state laws, statutes and regulations, nat’l conference of state leg. (2009), http://www.ncsl.org/research/health/tattooing-and-body-piercing.aspx. 57 see, e.g., 1 subst. crim. l. § 1.2 (2d ed.) (explaining the role of criminal law in prohibiting harmful conduct). 58 see, e.g., bruce j. winick, on autonomy: legal and psychological perspectives, 37 vill. l. rev. 1705, 1713 (1992) (explaining how mill’s harm principle underlies and justifies other-regarding legal restrictions on autonomy). 59 see, e.g., joel feinberg, legal paternalism, 1 canadian j. philosophy 105, 105 (1971) (“the principle of legal paternalism justifies state coercion to protect individuals from self-inflicted harm, or in its extreme version, to guide them, whether they like it or not, toward their own good.”). 60 see, .e.g, thaddeus mason pope, is public health paternalism really never justified? a response to joel feinberg, 30 okla. city u. l. rev. 121, 122 (2005) (exploring paternalism as a justification for restricting self-regarding behaviors). 61 see, e.g., danielle augustson & alyssa george, prostitution and sex work, 16 geo. j. gender & l. 229, 230 (2015) (noting the illegality of consensual prostitution in most states). 548 indiana health law review vol. 12:2 risks of violence and organized crime,62 to dignitary and paternalistic considerations.63 prohibitions on certain private sexual behaviors, which, though antiquated, remain in many jurisdictions, are grounded in the notion of law as a form of public morality—and perhaps a residual sense of disgust.64 these, though, are the minority: legal denials of autonomy to adults primarily occur in those domains where harm to others not only would be likely but is the purpose of the action itself—like rape or battery.65 these, then, in contrast to the majority of legal regimes that deny autonomy to juveniles, reflect not a balancing of stakeholder interests, a utilitarian calculus, or paternalism, but the law’s core public protective function. 2. delegated autonomy in some domains, the law prohibits minors from engaging in certain behaviors that would be lawful for adults. yet, rather than a total or categorical prohibition, it delegates to a parent or guardian the responsibility of authorizing the juvenile to engage in the action (or not). we call this category of laws “delegated autonomy,” although it could also be conceived of as “delegated denials of autonomy.” delegated autonomy is common in the medical decision-making arena. generally, adolescents cannot obtain medical care of even the simplest kinds without 62 see, e.g., james m. cole, guidance regarding marijuana enforcement, memorandum for all united states attorneys, u.s. dep’t of justice 1-2 (aug. 29, 2013) (listing federal priorities for enforcing marijuana prohibition, including sales to minors, criminal enterprises, diversion to prohibition states, pretext for trafficking other drugs, violence and firearms, drugged driving, cultivation on public lands, and use on federal property). 63 see, e.g., kevin s. toll, the ninth amendment and america's unconstitutional war on drugs, 84 u. det. mercy l. rev. 417, 443-44 (2007) (explaining and rejecting paternalistic and moralistic legal restrictions on autonomy with respect to drug use). 64 see augustson & george, supra note 61; see also leon kass, the wisdom of repugnance: why we should ban the cloning of humans, 216 new repub. 17, 19 (1997) (arguing that disgust forms a valid basis for ethics and regulation). 65 see supra note 57. 2015 549 how developmental neuroscience can inform legal regimes governing adolescents express authorization from a parent or guardian.66 typically, a student cannot even get an aspirin or tylenol from a school nurse without advance parental permission.67 in more medically serious situations, a minor cannot obtain treatment at a hospital emergency department without appropriate adult consent unless the medical need is so urgent that consent cannot be obtained in time to avoid a life-or-death situation.68 nor can teens opt into voluntary medical procedures, such as cosmetic surgery. however, in all these cases, the adolescent can obtain the medical services—including cosmetic interventions—with the consent of the parent or guardian, a delegation of autonomy.69 and, adolescents retain some individual autonomy in this arena. even though they cannot independently consent to medical treatment, they have the freedom to give or withhold their assent.70 assent is willingness; if the adolescent is unwilling to go through with a treatment directed by or consented to by the parent or guardian, it can constitute a violation of medical ethics (if not law) for the medical professional to go forward over the adolescent’s objections.71 delegated autonomy regimes arise in a few areas apart from medical decision-making; a minor generally cannot marry but may, in some states, be 66 minors and the right to consent to health care, 3 guttmacher report on pub. policy (2000), available at http://www.guttmacher.org/ pubs/tgr/03/4/gr030404.html. 67 see, e.g., school health services, sch. dist. of pickens cty., available at http://www.pickens.k12.sc.us/pages/parents/handbook/ school-health-services.aspx (“no aspirin and/or products containing aspirin will be given at school without physician and parent permission.”). 68 see minor consent to medical treatment laws, nat’l dist. attorneys ass’n (jan. 2013), http://www.ndaa.org/pdf /minor%20consent%20to%20medical%20treatment%20%282%29.pdf. 69 see plastic surgery for teenagers briefing paper, am. soc’y of plastic surgeons, available at http://www.plasticsurgery.org /news/briefing-papers/plastic-surgery-for-teenagers.html (“as with any surgery, parental consent is required for all plastic surgery procedures performed on teens younger than 18 years old.”). 70 see committee on bioethics, informed consent, parental permission, and assent in pediatric practice, 95 pediatrics 314, 315 (1995). 71 see id. at 316. 550 indiana health law review vol. 12:2 permitted to marry if he or she has parental consent.72 further, minors cannot join the military but may do so with the permission of a parent.73 3. graduated autonomy laws that operate on delegated autonomy require parental or guardian permission; they are binary, on/off regimes. some laws relating to adolescents are less categorical; rather, they provide for gradual, or graduated, autonomy for minors. this approach permits teens to exercise partial autonomy and achieve full capacity based on age, without parental consent. graduated autonomy regimes may be found in range of legal domains. increasingly, states are experimenting with graduated autonomy regimes for licensure of drivers, permitting limited driving hours and distances to younger drivers and requiring adult supervision for early driving, then gradually—based on hours driven and the age of the driver—permitting full driving privileges.74 similarly, teens can enter into employment without the consent of a parent or guardian, but the law retains a protective function by limiting the hours, types of work, and working conditions of minors.75 in the area of sexual relations, the law, too, provides for graduated autonomy.76 sexual self-expression 72 see teens/minors marriage license laws, us marriage laws (2014), http://www.usmarriagelaws.com/search/united_states /teen_marriage_laws/. 73 10 u.s.c. § 505 (2015). 74 see graduated driver licensing (gdl) laws, governors highway safety ass’n (may 2015), http://www.ghsa.org /html/stateinfo/laws/license_laws.html. 75 see child labor provisions for nonagricultural occupations under the fair labor standards act, child labor bulletin 101, wh1330, u.s. dep’t labor wage & hour div. (feb. 2013), http://www.dol.gov/whd/regs/compliance/childlabor101.pdf. 76 in indiana, for example, if one partner is underage, the law allows a defense to prosecution if the couple are in an ongoing relationship and not more than four years apart in age. see ind. code ann. § 35-42-4-9. 2015 551 how developmental neuroscience can inform legal regimes governing adolescents is a core area of autonomy and identity formation,77 yet can be fraught with risk. states vary considerably but the general trend is toward allowing adolescents the same autonomy to engage in sexual relations with each other that adults enjoy, but protecting them from sexual advances and potential sexual exploitation by adults.78 hence, most states have statutory rape laws that criminalize adult sexual conduct with teens yet also have “romeo and juliet” exceptions that ensure sexual relationships between same or similar-aged teens are not construed as criminal exploitation, or that teen-to-teen sexting is not charged as child pornography.79 we conceive of this as a “graduated autonomy” regime because it allows juveniles to experience their developing sexual autonomy in a limited or quasiprotected way while precluding certain sexual relationships that are more likely to be damaging or exploitative; in this way, it is somewhat analogous to graduated driving regimes. it is difficult to identify a principled distinction between subject matters governed by delegated autonomy versus graduated autonomy regimes. in areas characterized by graduated autonomy, generally the activities governed are individually and socially beneficial but carry risks of various kinds and require the exercise of judgment.80 accordingly, allowing young people to gain some experience while protecting them—and others—from the risks of unlimited autonomy seems reasonable. however, the same may be said of the activities typically governed by a delegated 77 see lawrence v. texas, 539 u.s. 558 (2003) (“liberty presumes an autonomy of self that includes freedom of thought, belief, expression, and certain intimate conduct.”). 78 see supra note 76. 79 see summary of current state laws: statutory rape – criminal offenses, assistant sec’y planning & evaluation, dep’t health & human serv., http://aspe.hhs.gov/hsp/08/sr/statelaws/summary.shtml (last visited may 17, 2015). 80 consider driving, a ubiquitous activity integral to autonomous decision-making and that connects individuals with society through recreational activities, education, and employment. driving can have serious health consequences to the driver as well as third parties, but the importance of the activity warrants graduated autonomy. 552 indiana health law review vol. 12:2 autonomy regime: medical decision making and sexual decision making both fundamentally relate to the body of the young person in question, both require certain maturity and understanding of risks to self and others. indeed, medical decision making may appear to be less likely to involve the risky and impulsive decision making almost inherent in sexual exploration. holding aside problems of administrability, a principled argument could be made for switching these two regimes. we are not seriously advancing such a proposal, but we raise the point to highlight the lack of consistency that underlies many of the legal choices relating to the degrees of adolescent autonomy in particular contexts. 4. total autonomy in some areas, the law provides adolescents with autonomy—at least front-end autonomy—equal to that enjoyed by adults, unrestricted by considerations of age or maturity.81 but this is not because, in these selected areas, youth are as mature as adults; rather, these categories consist of a heterogeneous set of practical and policy considerations that have led to isolated autonomy carveouts. these include, non-exhaustively, adolescents’ ability to admit themselves without parental consent for medical treatment for substance misuse or mental health disorders;82 in some states, to obtain an abortion without parental or guardian notification or consent;83 to obtain medical advice and services related to contraception;84 to marry, if the female is pregnant.85 adolescents may also 81 “front-end autonomy” refers to the fact that the law treats adolescents the same as adults with respect to taking particular actions, though it may later intervene to protect adolescents from, or punish them for, the consequences of those actions. 82 see supra note 66. 83 see state policies in brief: an overview of minors’ consent law, guttmacher inst. (may 1, 2015), http://www.guttmacher.org /statecenter/spibs/spib_omcl.pdf 84 id. 85 see marriage laws of the fifty states, district of columbia and puerto rico, cornell legal information inst., 2015 553 how developmental neuroscience can inform legal regimes governing adolescents enter into contracts with the same front-end autonomy as adults but, as with adults who suffer from various forms of diminished capacity, may later revoke the contract.86 5. censure-based responsibility the criminal law embodies both a protective and a punitive attitude toward juveniles.87 the juvenile justice system is popularly believed to set up a continuum of responsibility based on age and the harm caused.88 so, the younger the juvenile, the less responsible; the older the juvenile, the more responsible—a linear continuum on which responsibility increases gradually with age and maturity. in practice, however, various legislative efforts to respond to sensational—or sensationalized—cases of violence have led to a much harsher and less developmentally informed juvenile criminal system.89 despite historical efforts to establish a legal continuum of criminal responsibility, with lesser responsibility for younger individuals, contemporary state criminal law instead has a set of statutory rules that direct some juveniles into the adult system and others into the juvenile system, even where the juvenile offenders are the same age.90 the determinations generally are made on the basis https://www.law.cornell.edu/wex/table_marriage (last visited aug. 12, 2015). 86 see supra note 11. 87 see supra note 9. 88 see, e.g., simona ghetti & allison d. redlich, reactions to youth crime: perceptions of accountability and competency, 19 behav. sci. law 33, 45 (2001) (finding that people perceive an increase in blameworthiness and accountability for criminal actions perpetrated by juveniles in accordance with their age). 89 see, e.g., brenda gordon, a criminal's justice or a child's injustice? trends in the waiver of juvenile court jurisdiction and the flaws in the arizona response, 41 ariz. l. rev. 193, 194 (1999) (“nationally, state policymakers, responding to public outrage and fears about increasing juvenile crime, are advocating ‘get tough’ policies in an apparent attempt to incapacitate specific juvenile criminals and to deter violent juvenile crime.”). 90 juvenile age of jurisdiction and transfer to adult courts, nat’l conference of state leg. (oct. 1, 2014), http://dx.doi.org/10.1002/bsl.426 554 indiana health law review vol. 12:2 of the harm the juvenile caused, not his or her age (much less his or her individual degree of maturity).91 the prevalence of adult penalties, and even incarceration in adult prisons for young adolescents, grew out of a tough on crime movement during the 1980s that resulted in significant reform in juvenile law.92 the mantra of the day, driven by fear of a new generation of crack-baby “superpredators,” was “adult time for adult crime.”93 instead of a close examination of a particular juvenile’s degree of maturity, criminal law generally looks to the external factor—the crime committed. the reasoning that underlies these laws is that if a juvenile causes serious harm, then he or she is not truly a child but rather an adult-like criminal in a child’s body.94 we call this “censure-based” responsibility because the degree of penalty and the form of punishment focus on the degree of censure that is appropriate to the harm itself, rather than to any determination about the personal culpability of the offender who caused the harm. these laws generally do not provide prosecutors or judges with the discretion to consider the alternative explanation: that the juvenile’s actions, and the resulting harm, could flow from a flawed thought process characteristic of juveniles, such as not understanding risk, or not making good risk/reward calculations, or being unduly prone to poor decision-making in the peer context—much like the teens in the armpit-firehighway-rollover accident.95 that case, which opened this article, is a perfect example of where stereotypically poor teen decision-making caused an accident—an accident that could have been charged as an adult crime if, through sheer http://www.ncsl.org/research/civil-and-criminal-justice/juvenile-age-ofjurisdiction-and-transfer-to-adult-court-laws.aspx. 91 see supra note 9. 92 see supra note 18. 93 see hudson, supra note 17. 94 see gordon, supra note 89, at 225 (explaining that flawed systems treat juvenile offenders as “’criminals who happen to be young, not children who happen to be criminals.’”) (quoting alfred s. regnery, getting away with murder: why the juvenile justice system needs an overhaul, 34 pol'y rev. 65 (1985)). 95 see supra note 1. 2015 555 how developmental neuroscience can inform legal regimes governing adolescents moral luck, the outcome had been worse than in fact it was. given the uneven nature of juvenile development, we might ask whether such a continuum would be the appropriate way of accounting for juvenile difference in any event. we turn to this question in parts iii and iv, and instead propose that a matrix of considerations replace the model of the continuum. c. the result—multiple regimes lead to inconsistent outcomes these multiple regimes lead to legal outcomes that are internally inconsistent and even counterintuitive. in some ways, juveniles are entrusted with significant, even lifeand-death responsibilities. in other ways, they are denied basic autonomy in even minor decisions. a fifteen-year-old girl can legally work thirty hours a week at wal-mart, consent to sex with the same aged boyfriend, get married if pregnant, and check herself into drug rehab without parental consent.96 with parental consent, she can get a nose job and breast implants.97 but she cannot get an aspirin at school without parental consent,98 and she cannot vote, get a tattoo, drink, or smoke.99 in some jurisdictions, she cannot legally drive without an adult in the car.100 and yet, if her reckless driving kills somebody, she can be waived into the adult criminal justice system and be sentenced as an adult to decades in prison.101 do these different legal regimes make any sense or do they just comprise a historically contingent pastiche? in parts iii and iv, we argue that it is bit of both: some of these legal choices about the degree of autonomy to grant, or responsibility to impose upon, adolescents make more sense, both as a matter of law and of developmental biology, than they seem to on the surface—while others fly in the 96 see supra part i.b. 97 see supra note 69. 98 see supra note 67. 99 see supra notes 52, 56; see 21 u.s.c. § 387f. 100 see supra note 74. 101 see supra part i.b.5. 556 indiana health law review vol. 12:2 face of the principles of both sets of systems. the disparate legal approaches to adolescent decision making may be perfectly appropriate in certain circumstances. but they also may produce peculiar and inconsistent results. not only do some of the conflicts in legal regimes that govern and constrain juvenile behavior appear to be counterintuitive, they do not accord with the psychological and biological differences between juveniles and adults. increasing understanding of the brain may now enable more sophisticated consideration of the relationships between the biology of adolescence and the law’s normative underpinnings and policy goals. iii. how – and why – adolescents are different a. the brain’s adolescence the adolescent brain has pronounced strengths and weaknesses.102 to the extent that there is validity to the idea of general intelligence, or “g,” teens are as smart as they ever will be.103 general intelligence measures of performance on tasks such as cognitive speed and the ability to coordinate cognitive and motor performance increase through adolescence, peak at about age twentyfour—the exact age at which the brain is said to be “adult” and “mature”—and decline from there.104 in important ways, late adolescents are mental athletes who are at their peak.105 colloquially, we may say that teens are “dumb” but they most assuredly are not—or at least not more dumb 102 for an excellent overview of adolescent brain development, see generally ronald e. dahl, adolescent brain development: vulnerabilities and opportunities, 1021 annals n.y. acad. sciences 1 (2004). 103 see gottfredson, supra note 23. 104 see joseph j. thompson et al., over the hill at 24: persistent age-related cognitive-motor decline in reaction times in an ecologically valid video game task begins in early adulthood, 9 plos one e94215 (2014). 105 see j.p. rushton & c.d. ankney, whole brain size and general mental ability: a review, 119 int. j. neurosci. 692-732 (2009) (showing that adult brains shrink about two grams per year and lose corresponding degrees of function). http://dx.doi.org/10.1196/annals.1308.001 http://dx.doi.org/10.1371/journal.pone.0094215 http://dx.doi.org/10.1080/00207450802325843 2015 557 how developmental neuroscience can inform legal regimes governing adolescents on average than adults. when we say that teens are “dumb,” what we mean is: they predictably do dumb things.106 they take bad risks and make bad bets.107 they engage in actions for the wrong reasons, and to impress the wrong people.108 and, when making decisions, they frequently fail to bring to bear relevant facts or information that they already know—but that they cannot seem to make use of in the moment.109 this juxtaposition of ordinary, adequate intelligence and sub-par decision making indicates a disconnect. indeed, there are literal disconnects: as different regions of the adolescent brain mature at different rates, and develop connections to each other only during and through the maturation process, it is possible for an adolescent to know something with one part of his or her brain but not with another—or to be less able than an adult to mediate between conflicting mental processes and arrive at an integrated decision.110 in particular, adolescents suffer relative to adults in their capacities to assess what is a good versus a bad risk, to inhibit impulses, and to silence the inner roar of concerns about what their peers think of them.111 this short section will first define adolescence and then look at the developmental neuroscience findings that help explain these deficits. “adolescence” denotes the time between childhood and adulthood, typically defined as beginning with the 106 see, e.g., supra note 1. 107 see leah h. somerville & b. j. casey, developmental neurobiology of cognitive control and motivational systems, 20 current opinion in neurobiology 236, 236 (2010). 108 see leah h. somerville et al., the medial prefrontal cortex and the emergence of self-conscious emotion in adolescence, 24 psychological science 1554, 1554 (2013) (explaining the neurological role of peer influence on adolescent decision making). 109 see somerville & casey, supra note 107, at 237 (describing how adolescents overvalue immediate rewards to the detriment of goaloriented behavior). 110 see steinberg, supra note 29 (explaining that the adult brain distributes decision making process across multiple structures, integrating such functions as risk evaluation and planning ahead, whereas in adolescents, “[i]t’s as if the brain’s accelerator is pressed to the floor before a good braking system is in place.”). 111 see generally somerville & casey, supra note 107. http://dx.doi.org/10.1016/j.conb.2010.01.006 http://dx.doi.org/10.1177/0956797613475633 558 indiana health law review vol. 12:2 physiological onset of puberty, between ages eleven and thirteen, and ending with early adulthood, by or before age twenty-four.112 these physical changes correlate with the acquisition of new responsibilities and social roles, placing adolescents in the midst of a struggle to form their identities while managing peer pressure and heightened emotional reactivity—a characteristic recipe for risky behavior and “sensation seeking.”113 in addition to these social and cultural changes, adolescents experience rapid physical changes from growth spurts to hormone swells.114 adolescents thus inhabit a cacophony of physical transformation, social experimentation, and expansion of responsibilities, a sensitive period for social and identity formation.115 spurred by the onset of puberty typically around age eleven or twelve for girls and twelve to thirteen for boys, secondary sexual characteristics and reproductive capacity develop, largely initiated by the release of hormones from the hypothalamus and pituitary gland.116 the brain’s overall size has already peaked a year or two before puberty begins,117 but maturity comes with the selective pruning of unneeded brain connections and the strengthening of the remaining connections among brain regions throughout adolescence.118 112 see, e.g., pfeifer & blakemore, supra note 20, at 1; see also thompson et al., supra note 104 (establishing 24 as the age of neurological adulthood). what constitutes “adulthood” is not exactly clear, and can refer to the maturation of physiological and psychological capacities for independence and self-regulation, a legal determination of adulthood, and/or a cultural affirmation of adulthood. 113 see leah h. somerville et al., a time of change: behavioral and neural correlates of adolescent sensitivity to appetitive and aversive environmental cues, 72 brain and cognition 124, 125 (2010). 114 see, e.g., pfeifer & blakemore, supra note 20, at 3. 115 see generally id. 116 see, e.g., puberty, the patient educ. inst., inc. (2012), available at http://online.mufasser.com/modules_v3/ peditrcs/pdfp01a1/pdfp0101/pdfp0101.pdf. 117 see jay n. geidd, the teen brain: insights from neuroimaging, 42 j. adolescent health 335, 336 (2008). 118 see b.j. casey et al., the adolescent brain, 28 developmental review 62, 67 (2008). http://dx.doi.org/10.1016/j.bandc.2009.07.003 http://dx.doi.org/10.1016/j.jadohealth.2008.01.007 http://dx.doi.org/10.1016/j.dr.2007.08.003 2015 559 how developmental neuroscience can inform legal regimes governing adolescents along with social and physical changes, the adolescent brain undergoes significant structural and functional transformations. animal studies demonstrate that puberty catalyzes a spike in axon and synapse production, ultimately pruned back late in adolescence.119 fiber density between the amygdala and prefrontal cortex (pfc) continues to increase into the early stages of adulthood.120 white matter accrues through adolescence and into early adulthood, caused by myelination, the insulation of fibers with cholesterol, which improves their electrical efficiency.121 pruning removes unnecessary neurological connections, and persists throughout adolescence more significantly in the pfc than the accumbens, suggesting an earlier maturation of the accumbens.122 the increased development and interconnection among these brain regions temporally correlates with the new roles, interests, and responsibilities of adolescents, but the brain’s uneven maturation renders adolescents somewhat unequipped to handle these experiences. in addition to these structural changes, adolescence involves changes to neurotransmitter systems in both cortical and subcortical areas of the brain.123 dopamine regulates excitatory and inhibitory communications among the accumbens, amygdala, and pfc and its expression peaks differentially in these areas over time.124 dopamine receptors proliferate along the pathways connecting the limbic systems and the pfc more early in adolescence than 119 see id. at 336-37. 120 see somerville et al., supra note 113, at 128. 121 vincent j. schmithorst & weihong yuan, white matter development during adolescence as shown by diffusion mri, 72 brain & cognition 16, 16–25 (2010). 122 see somerville et al., supra note 113, at 127. 123 see b.j. casey et al., the adolescent brain, 1124 annals n.y. acad. sciences 111, 113 (2008). 124 id. (“dopamine projections to the prefrontal cortex continue to develop into early adulthood, with dopamine levels peaking in the prefrontal cortex during adolescence versus earlier or later in life in nonhuman primates and in rats. dopamine receptor expression is highest in the accumbens during early adolescence.”). http://dx.doi.org/10.1196/annals.1440.010 http://dx.doi.org/10.1016/j.bandc.2009.06.005 560 indiana health law review vol. 12:2 later on.125 this evidence produces a complex map of structural, connective, and communicative changes involving subcortical and cortical areas of the brain, which can help shed light on the formative years of adolescence.126 verifying this data in human studies involves the use of magnetic resonance imaging (mri) technologies such as structural mri, diffusion tensor imaging (dti), and functional mri.127 these devices enable scientists to study neurological structures and connections, as well as the realtime functioning of subjects’ brains as subjects perform various tasks or respond to stimuli.128 mri studies have produced important data about the size and composition of brain regions during development. the prefrontal cortex takes a particularly long time to mature, and the subcortical basal ganglia undergo significant changes.129 these subcortical ganglia are implicated in numerous functions, but for purposes of understanding adolescent behavior, we can focus on their role in behavior selection (e.g., “between these several options, what would be the right thing to do now?”)130 and cognitive coordination (“i have several different thoughts and impulses. how do i align my thoughts, feelings, and behaviors at this moment?”).131 michael gazzaniga, the founder of the field of cognitive neuroscience, has called the pfc the seat of “free won’t”— because of its role in overriding emotional impulses.132 related executive functions include planning, sequencing, organization, inhibition, problem solving, and behavior 125 see adriana galvan, adolescent development of the reward system, 4 frontiers in human neuroscience 1, 2 (2010). 126 see casey et al., supra note 123, at 114. 127 see casey et al., supra note 118, at 65. 128 see id. at 65-70. 129 see casey et al., supra note 123, at 114. 130 v.s. chakravarthy et al., what do the basal ganglia do? a modeling perspective, 103 biological cybernetics 237, 244-49 (2010). 131 andrea stocco et al., conditional routing of information to the cortex: a model of the basal ganglia's role in cognitive coordination, 117 psychol. rev. 541 (2010). 132 see michael s. gazzaniga, the ethical brain: the science of our moral dilemmas 95-96 (2006). http://dx.doi.org/10.3389/neuro.09.006.2010 http://dx.doi.org/10.1007/s00422-010-0401-y http://dx.doi.org/10.1037/a0019077 2015 561 how developmental neuroscience can inform legal regimes governing adolescents control,133 and can be measured with neuropsychological tests, such as the go/no-go task of inhibitory control.134 the relatively late development of the pfc and maturation of its connections to impulse-generating and emotion-generating regions of the brain may help explain the relative impulsivity and risk-preferring nature of adolescents—even when they “know better.”135 dti shows promise in providing a finer grained analysis of how the brain strengthens some connections and prunes back others.136 white matter connections between the pfc and other areas have been associated with working memory and impulse control.137 again, connections among different areas develop at different rates and times during adolescence.138 enabling researchers to look at function in addition to structure, fmri studies have confirmed the role of the pfc in the development of cognitive control and decision-making.139 task performance studies show that adult brains specialize particular prefrontal regions for certain tasks, whereas children’s prefrontal areas function more diffusely, suggesting that neurological development involves both changes within brain regions and among their connections.140 133 see, e.g., akira miyake et al., the unity and diversity of executive functions and their contributions to complex “frontal lobe” tasks: a latent variable analysis, 41 cognitive psychology 49, 53-59 (2000). 134 see, e.g., kurt p. schulz et al., does the emotional go/no-go task really measure behavioral inhibition? convergence with measures on a non-emotional analog, 22 archives of clinical neuropsychology 151(2007) (supporting the incorporation of emotionally-salient stimuli into a traditional behavioral inhibition test). 135 see casey et al., supra note 123, at 116-17. 136 id. at 115. 137 id. (noting that prefrontal-parietal connections pertain to working memory and prefrontal-basal ganglia connections correlate with impulse control). 138 id. at 116-17. 139 id. at 115. 140 id. (referring to “flanker, stroop, and go/no-go” tasks). http://dx.doi.org/10.1006/cogp.1999.0734 http://dx.doi.org/10.1016/j.acn.2006.12.001 562 indiana health law review vol. 12:2 b. developmental disparity between pfc and limbic system adapting to new roles and responsibilities, adolescents navigate unfamiliar territory by trial and error, seeking novelty, excitement, and reward.141 this often manifests itself as risky behavior as adolescents develop an experiential base to understand their newfound impulses and relationships.142 uneven and disparate neurological development underlies these suboptimal behaviors. prefrontal regions of the brain, which enable executive functions such as “top down,” inhibitory control over impulses, develop along with white matter at a relatively even, linear rate throughout adolescence.143 by correlating a steady increase in performance on impulse control tasks, such as resisting immediate rewards, with prefrontal brain regions of increasingly aged subjects, scientists have theorized that the development of top-down neurological control of impulses follows a linear trajectory.144 this means that not only do the prefrontal regions themselves develop slowly, but that their long-range connections to other parts of the brain develop slowly as well, and the cognitive capacities they facilitate do not mature until late in adolescence.145 by contrast, the subcortical regions, including the amygdala, hippocampus, and thalamus—correlated with emotion, motivation, and reward—develop rapidly during early adolescence in terms of both structure and function, outpacing the slower maturation of the prefrontal regions.146 since interactions between the cortex and subcortical regions play a major role in producing behavior, the disparity between the emotional and intellectual 141 see, e.g., galvan, supra note 125, at 6-7. 142 id. 143 see b.j. casey et al., the storm and stress of adolescence: insights from human imaging and mouse genetics, 52 developmental psychobiology 225, 226 (2010). 144 see somerville & casey, supra note 21, at 238. 145 id. at 239. 146 see b.j. casey et al., braking and accelerating of the adolescent brain, 21 j. research on adolescence 21, 22 (2011). http://dx.doi.org/10.1002/dev.20447 http://dx.doi.org/10.1111/j.1532-7795.2010.00712.x 2015 563 how developmental neuroscience can inform legal regimes governing adolescents components of decision making create various decisionmaking biases and vulnerabilities.147 c. emotional control and reactivity manifesting itself as an overvaluation of emotional information, this developmental disparity often leads to poor decisions when emotional and intellectual evaluations conflict.148 an adolescent may “know better” than to take a particular, emotionally salient course of action, but poor cognitive control biases the individual in favor of emotional reactivity.149 with an insufficiently developed capacity for “free won’t,” adolescents have trouble inhibiting impulsive, risky, or aggressive inclinations.150 logical calculations of risk and reward take a back seat to emotional significance and immediate reward.151 this may be related to weak connections between emotional processing regions of the brain and more cognitive, intellectual regions. it may also be related to heightened activity in the nucleus accumbens, a brain region associated with reward processing. the amygdala assigns emotional significance to information determined to be salient, prioritizing it for translation into behavior.152 the amygdalae of adolescents tend to show larger responses than in adults and correlate with a poor ability to control emotional responses related to 147 id. 148 id. at 22 (“[i]n emotionally salient situations, subcortical systems will win out (accelerator) over control systems (brakes) given their maturity relative to the prefrontal control system.”). 149 see casey et al., supra note 123, at 116-17 (“[w]hen a poor decision is made in an emotional context, the adolescent may know better, but the salience of the emotional context biases his or her behavior in opposite direction of the optimal action.”). 150 see id. at 112. 151 see id. 152 see geidd, supra note 117, at 338; see also somerville et al., supra note 113, at 126 (“the amygdaloid complex, a cluster of nuclei situated in the medial temporal lobe, plays a critical role in processing information of biological significance, including emotionally evocative stimuli, potential threats, and cues depicting the emotional states of others.”). 564 indiana health law review vol. 12:2 aggressive behaviors and mood problems.153 prefrontal areas regulate this process based on environmental feedback.154 a major antecedent of adolescent emotional reactivity lies in the individual’s emergent task of fitting into new social groups.155 as children enter adolescence, they develop new social roles and experience heightened sensitivity to peer approval.156 fmri studies of adolescents engaged in the game of “cyberball,” simulating experiences of social inclusion and exclusion, show that the ventral anterior cingulate cortex and insula respond to exclusion and that the ventrolateral pfc activates less in adolescents than adults.157 another task simulating internet chatting demonstrated insula activation during acceptance, not rejection, suggests that the number of peers involved and the subject’s interest in the approval of each of those peers, affects the neurological response to acceptance or rejection.158 these and other studies of peer influence show that social acceptance and rejection implicate affective responses in the brain, significantly affecting adolescent decision-making by playing into their characteristic overvaluation of affective information.159 153 see somerville et al., supra note 113, at 125 (“[a]dolescents’ negative emotional states are not only frequent but their emotional responses also tend to be more intense, variable and subject to extremes relative to adults.”). 154 see derek g.v. mitchell, the nexus between decision making and emotion regulation: a review of convergent neurocognitive substrates, 217 behavioural brain research 215, 226 (2011) (“[c]ommon functional computations underlie adaptive decision making and emotional regulation; furthermore, these computations are likely governed by overlapping areas of prefrontal cortex.”). 155 leah h. somerville, the teenage brain: sensitivity to social evaluation, 22 current directions in psychological science 121, 121 (2011). 156 see pfeifer & blakemore, supra note 20, at 5-6 (“compared with children, adolescents are more sociable, form more complex and hierarchical peer relationships and are more sensitive to acceptance and rejection by peers.”). 157 id. at 6. 158 id. 159 id. at 7 (“[peer interactions of various types are highly likely to arouse an affective response in adolescents….”). http://dx.doi.org/10.1016/j.bbr.2010.10.030 http://dx.doi.org/10.1177/0963721413476512 2015 565 how developmental neuroscience can inform legal regimes governing adolescents none of this is to suggest that emotion only contributes negatively to decision-making. the constructionist approach to neurobiological psychology holds that emotion and rational cognition are both types of attention, each with a proper role in decision-making.160 d. reward and impulsivity the lack of prefrontal development in combination with heightened limbic activity (specifically in the accumbens) correlates with an overvaluation of rewards and short-term gains.161 scientists differ on how to model adolescents’ uniquely impaired processing of incentives: some suggest that an under-recruitment of relevant brain regions renders modest rewards unappealing, leading adolescents to be disproportionately motivated by expectations and desires of high reward.162 others believe that neurological overactivity inflates sensitivity to reward, causing adolescents to seek novelty and sensation.163 some studies suggest that these models may be reconciled by noting that they correlate with different phases of reward processing. the under-activity model emerged from studies of anticipating rewards, whereas the over-activity model correlates with receiving rewards.164 reward overvaluation can also be modeled interconnectively; the “triadic” model suggests that limitations in prefrontal executive control and amygdalamediated harm avoidance allow the overactive ventral striatum to control the translation of overvalued incentives into behavior.165 160 kristen a. lundquist et al., the brain basis of emotion: a metaanalytic review, 35 behavioral and brain sci. 121, 142 (2012) (discussing the constructionist approach to emotion, which holds that “affect, conceptualization, and executive attention (and perhaps other psychological operations) cooperate to realize a behavioral outcome.”). 161 see somerville & casey, supra note 21, at 237. 162 see galvan, supra note 125, at 1. 163 id. 164 see charles geier & beatriz luna, the maturation of incentive processing and cognitive control, 93 pharmacological biochemistry and behavior 212, 218 (2009). 165 id. at 213. http://dx.doi.org/10.1017/s0140525x11000446 http://dx.doi.org/10.1016/j.pbb.2009.01.021 566 indiana health law review vol. 12:2 a similar model holds that underdeveloped aspects of cognitive control, such as inhibition and working memory, combine with reward overvaluation to result in risky behavior.166 response inhibition enables individuals to consider behavioral alternatives and choose appropriate actions; deficiencies in this system can bias a decisionmaker in favor of short-term gains.167 concomitant deficiencies in working memory hinder comparisons of incentive information associated with multiple alternatives.168 in other words, a certain amount of cognitive control is required to process and compare expected features of different behavioral options, such as estimations of reward value, the likelihood of actually getting the reward, and one’s experiential history related to that reward.169 importantly, studies show that adolescents are not necessarily bad at evaluating the risks of behaviors, but they have trouble integrating that information with other salient factors, which may be overvalued themselves, such as peer influence and affective information.170 the developmental lacuna between prefrontal and limbic systems represents not only the evolutionary process of seeking novelty, pleasure, and independence, but also an imbalance between these emotional, short-sighted adolescent drives and the “self-regulatory competence” expected of adults.171 iv. three cases of juvenile law analyzed via neurodevelopmental criteria adolescents are not uniformly disadvantaged relative to adults. some legally relevant contexts play into these 166 id. at 217-18. 167 id. at 217. 168 id. at 217-18. 169 id. 170 kerstin konrad et al., brain development during adolescence: neuroscientific insights into this developmental period, 110 deutsches ärzteblatt int’l 425, 428 (2013). 171 see somerville et al., supra note 113 (quoting laurence steinberg, risk taking in adolescence: what changes, and why?, annals n.y. acad. sci. 51 (2004)). http://dx.doi.org/10.3238/arztebl.2013.0425 http://dx.doi.org/10.1196/annals.1308.005 2015 567 how developmental neuroscience can inform legal regimes governing adolescents disadvantages and vulnerabilities, to greater or lesser extents, while others do not. surges in novelty-seeking behavior and sensitivity to peer influence, combined with the slower maturation of impulse control, lead to characteristically emotional decision-making and poor risk/reward evaluations.172 with this knowledge in hand, policymakers can have a more accurate starting point to map the particular vulnerabilities of adolescents onto legally significant behaviors. this can inform in more nuanced and precise ways the analysis of where the law ought, or ought not, to limit the autonomy it extends and the responsibility it imposes on adolescents. this part will examine three cases relating specifically to adolescents: the case of tattooing; the case of alcohol and tobacco regulation; and the case of criminal responsibility for intentional violence. it will then evaluate those topics in light of juvenile developmental neuroscience, the interests of other stakeholders, and the institutional considerations that frame them. the purpose is to use these cases as models for how lawmakers might analyze juvenile developmental neuroscience in behavioral, legal, and social context to inform lawmaking. the conclusions of these case studies inform the proposal that we make, for a formalized analytical matrix, in part iv. a. the case of tattooing tattooing presents an interesting case relative to the regulation of adolescent behavior. it seems serious and unserious at the same time. on the one hand, a tattoo is a life-long commitment.173 on the other hand, it is just body art; unlike drinking, driving, or using drugs, tattoos carry little to no risk of harming or killing oneself, and no such 172 see supra part ii. 173 see, e.g., olga khazan, the secret to a tattoo’s permanence: the immune system, the atlantic health (july 22, 2014), http://www.theatlantic.com/health/archive/2014/07/the-real-reasontattoos-are-permanent/374825/ (explaining why tattoos last a lifetime). 568 indiana health law review vol. 12:2 risk to others.174 does it make sense to have an absolute prohibition against adolescent tattooing, while permitting adolescents to check themselves into a drug treatment center or obtain an abortion—decisions that seem more momentous and weighty? examining the case of tattooing, it seems that the law makes sense on one view of what it is that law is supposed to do. but a closer examination shows that, despite the unfortunate relationship between tattooing and adolescent vulnerabilities in decision making, various extra-neuroscientific factors, including legal norms, social norms, and institutional considerations, must combine with judgments about adolescents to justify legal regimes relating to the practice. neurodevelopmental biology suggests that teens may need to be protected from making a bad decision relative to this activity more than relative to other kinds of activities, but the enactment of a legal prohibition still rests on a sort of aesthetic paternalism, a social choice that is certainly contestable and not required by particular scientific findings.175 tattooing seems to fit in with all major forms of adolescent psycho-social difference. tattooing is often related to significant peer influence.176 one need only look at the massively increased popularity of tattoos in the last 174 but see think before you ink: are tattoos safe?, fda consumer health information (october 2009), http://www.fda.gov/downloads/forconsumers/consumerupdates/ucm1 43401.pdf (explaining that tattoo needles and inks carry some risk of infection, allergic reaction, scarring, granulomas, and mri complications). 175 see feinberg, supra note 59, at 116 (“the state might even be justified in using its taxing, regulatory, and persuasive powers to make [a potentially risky activity] more difficult or less attractive; but to prohibit it outright for everyone would be to tell the voluntary risk-taker that even his informed judgments of what is worthwhile are less reasonable than those of the state, and that therefore, he may not act on them…. as a principle of public policy, it has an acrid moral flavor, and creates serious risks of governmental tyranny.”). query, however, whether adolescent neurological vulnerabilities justify a paternalistic approach. are teens—subject to their limited decision making capacities—voluntary risk-takers making informed judgments? 176 see, e.g., alden e. roberts & jerome r. koch, correlates of tattoos and reference groups, 99 psychological reports 933 (2006). http://dx.doi.org/10.2466/pr0.99.7.933-934 2015 569 how developmental neuroscience can inform legal regimes governing adolescents decade to see that, since it is socially acceptable or even desirable, more people do it.177 despite its popularity, it remains perceived as a risky or transgressive thing to do, because it can be accepted by one’s peer group but frowned upon by one’s parents’ generation; thus, it can mark both fitting in and rebelling, an irresistible combination for teen identity formation.178 it is also a sensation-seeking activity, as one might wonder what it feels like to get a tattoo or to walk around having one.179 and it may be the product of extreme temporal discounting: “i love this so much now that i cannot imagine being unhappy with it in the future. i will always want my favorite band’s name tattooed on my face.”180 given tattooing’s remarkable fit with each of the major vulnerabilities in average adolescent decision making, does this suggest that laws categorically barring juveniles from obtaining tattoos (even with parental consent), are blessed by biology? can we derive the right legal regime relative to tattoos from this analysis of the relationship between juvenile developmental biology and the social signification of the practice of tattooing? not quite: whether there is a role for the legal regulation of this behavior still depends on a normative account of what the law is supposed to do. barring tattooing is paternalistic and limits autonomy. tattooing does not have any significant negative externalities. if an individual gets a stupid tattoo, he or she alone suffers; it is not like drinking and driving, which presents significant risk to others. we might also ask whether the type of harm that an individual suffers from getting a regretted tattoo is the kind of harm from which the law is supposed to protect individuals. the kind of harm here is not like the harm of smoking, which can lead to disease and death, or the harm of unsupervised driving, which can lead to the deaths of 177 see, e.g., samantha braverman, one in five u.s. adults now has a tattoo, the harris poll (feb. 23, 2012). 178 see id. (showing that despite the increasing prevalence of tattoos, they are still largely seen as a sign of rebelliousness). 179 see somerville et al., supra note 113. 180 see geier & luna, supra note 164, at 217. 570 indiana health law review vol. 12:2 others. here, the harms (if any) are emotional and aesthetic. ought the law to be engaging in aesthetic paternalism? if so, should the law, on the same grounds, require a fortyeight-hour waiting period before a teen can get an unfortunate but trendy hair cut? if the aim of the laws categorically barring tattoos is to save juveniles from the long-term emotional regret of a bad decision, then should the law require that teens, e.g., receive judicial permission before breaking up with that really nice boy or girl who may be “the one”? on a libertarian view of the law, we could say “why is it a matter of concern for the state if somebody gets a horrible tattoo at seventeen that affects his or her professional and romantic prospects?” the law’s paternalism toward adolescents is the only justification for this legal regime.181 one might object that an adolescent deciding to get a tattoo interferes with the parent’s rights over the adolescent;182 but in that case, if the parent is the stakeholder whom the law aims to protect, the appropriate legal regime would be to permit tattoos with parental consent—or to allow parents to tattoo their children even without the child’s assent, which is prohibited. calling the law paternalistic not is intended to be pejorative here; we merely are making clear the role that the law is playing relative to adolescents in this context. in the case of tattooing, even though it implicates every teen vulnerability, there is no necessary outcome for the law. the law does tell us, though, that if we are concerned about the kinds of problems that do activate teen decisionmaking vulnerabilities and that have long-term negative consequences (even if emotional or aesthetic), then these are the kinds of features of a decision where law may have a case for getting involved. if one believes that there is an 181 see hodgson v. minnesota, 497 u.s. 417, 444 (1990) (“the state has a strong and legitimate interest in the welfare of its young citizens, whose immaturity, inexperience, and lack of judgment may sometimes impair their ability to exercise their rights wisely.”). 182 wisconsin v. yoder, 406 u.s. 205, 232-33 (1972) (explaining the traditional and fundamental right of parents to direct the upbringing of their children). 2015 571 how developmental neuroscience can inform legal regimes governing adolescents appropriate role for some graduated autonomy in the law, even in areas where there are no significant externalities, tattooing would be the paradigmatic example. b. the case of alcohol, tobacco, and other addictive substances just like getting a tattoo, vulnerability to misuse of alcohol, tobacco, and drugs of abuse arises from the combination of impulsivity, noveltyand sensation-seeking, overvaluation of affective information, and peer influence.183 the misuse of these substances can have particularly negative consequences on the developing brain.184 and, unlike tattooing, teens’ misuse of these substances and potential addiction to them can result in life-long harm or even death to the individual, and may lead to the deaths of others.185 thus, legal regimes that intend to consider the relationship between developmental neurobiology and the subject of regulation should attend to these factors in designing regulatory regimes. indeed, tobacco regulation has been a model in this area: following tobacco companies’ own insights that addicting children and young adolescents creates life-long customers, regulators have aggressively worked to limit juvenile access to all tobacco products.186 adolescence is itself a risk factor for the use of tobacco, alcohol, and drugs of abuse, and for the development of 183 see supra part ii; see also sunita bava & susan f. tapert, adolescent brain development and the risk for alcohol and other drug problems, 20 neuropsychol. rev. 398, 403 (2010) (finding that the “[p]redilection for risk-taking and sensation seeking during adolescence is associated with increased substance use and the potential for longterm health problems.”). 184 see bava & tapert, supra note 183, at 403-06 (explaining that adolescent substance use has detrimental effects on the brain’s structure and function, affecting cognitive capacities related to “attention, speeded information processing, spatial skills, learning and memory, and complex behaviors ….”). 185 see bharath chakravarthy et al., adolescent drug abuse – awareness & prevention, 137 indian j. med. res. 1021, 1021 (2013). 186 see, e.g., 21 c.f.r. § 1140 (2014) (prohibiting the sale and distribution of tobacco products to persons younger than 18). http://dx.doi.org/10.1007/s11065-010-9146-6 572 indiana health law review vol. 12:2 dependencies thereon.187 during the teen years, there is a sharp escalation in the use of alcohol, the most prevalent intoxicant.188 rates of substance use also jump in the early teen years and rise dramatically throughout adolescence.189 these behaviors provide substantial short-term rewards at the expense of long-term risks, implicating adolescents’ overvaluation of immediacy, pleasure, and recent experience relative to their limited ability to consider their future selves or the long-term implications that their actions may have on others.190 further, “[m]ost risky behaviors in humans—including alcohol abuse—occur in social situations,” implicating adolescents’ susceptibility to peer influence.191 adolescents are not the only people who use alcohol as a social lubricant, of course, or who leverage its well-known power to make one feel less awkward or to make others seem more interesting.192 however, adolescence is a “sensitive period” for social development, in which teens learn how to be social in the ways of their own 187 see b. j. casey & rebecca m. jones, neurobiology of the adolescent brain and behavior: implications for substance use disorders, 49 j. am. acad. child & adolescent psychiatry 1189, 1197 (2010) (“this imbalance between these developing systems [rapidly developing “bottom-up” motivational systems and slowly maturing “topdown” cognitive control systems] during adolescence may lead to heightened vulnerability to risk-taking behaviors and an increased susceptibility to the motivational properties of substances of abuse.”); see also substance abuse and mental health services administration, results from the 2012 national survey on drug use and health: summary of national findings, samhsa.gov (sept. 2013), http://www.samhsa.gov/data/nsduh/2012summnatfinddettables/nat ionalfindings/nsduhresults2012.pdf. 188 see bava & tapert, supra note 183, at 403. 189 see id. 190 valerie f. reyna & frank farley, risk and rationality in adolescent decision making: implications for theory, practice, and public policy, 7 psychol. science in the pub. interest 1, 13 (2006). 191 see casey & jones, supra note 187, at 1197. 192 ernest hemingway reportedly said, “i drink to make other people interesting,” but literary and social history does not lack for examples of similar sentiments. http://dx.doi.org/10.1016/j.jaac.2010.08.017 http://dx.doi.org/10.1111/j.1529-1006.2006.00026.x 2015 573 how developmental neuroscience can inform legal regimes governing adolescents society;193 reliance on alcohol instead of on developing social skills can impair them long into adulthood from learning how to be. use of such substances increase physical and social risks for the adolescent, and also can increase the risks that the adolescent poses to others.194 adolescent drug and alcohol use risks harm to “brain functioning, cognition, and behavior.”195 adolescents may be more vulnerable to the addictive and neurotoxic effects of alcohol.196 the developing brain may be negatively influenced by alcohol and marijuana, with “studies showing diminutions in neurocognitive functioning, especially attention, visuospatial functioning, and learning and retrieval of verbal and nonverbal information[.]”197 these functional impairments mimic the changes found in older patients with mild cognitive impairment or early stages of dementia.198 further, the brains of adolescents who use alcohol or marijuana heavily also show changes at more fundamental levels, including “morphological changes; anisotropic differences in white matter; and a more distributed functional network and recruitment of alternate brain regions.”199 the full meaning of some of these observations remains to be elucidated in future studies but general import of these changes is to suggest that the brain is functioning in less efficient ways. 193 see melissa dahl, age 12 is like a second toddlerhood, nymag science of us (march 12, 2015), http://nymag.com/scienceofus /2015/03/age-12-is-like-a-second-toddlerhood.html. 194 see, e.g., teens: alcohol and other drugs, amm acad. of child & adolescent psychiatry (july 2013), https://www.aacap.org /app_themes/aacap/docs/facts_for_families/03_teens_alcohol_and_oth er_drugs.pdf. 195 bava & tapert, supra note 183, at 403. 196 see casey & jones, supra note 187, at 1196. 197 bava & tapert, supra note 183, at 403 (internal citations omitted). 198 see, e.g., stella karantzoulis & james e. galvin, distinguishing alzheimer’s disease from other major forms of dementia, 11 expert rev. neurotherapeutics 1579 (2011) (describing visuospatial deficits in early dementia and alzheimer’s disease). 199 bava & tapert, supra note 183, at 403 (internal citations omitted). http://dx.doi.org/10.1586/ern.11.155 574 indiana health law review vol. 12:2 adolescent substance use likely implicates neurological proclivity for risky behavior, poor risk/reward evaluation, and an overvaluation of affective information.200 studies of adolescent binge drinkers showed that subjects performed worse on a common negative learning paradigm, known as the iowa gambling task (igt), than non-drinkers.201 the igt measures how effectively a person can learn from a negative experience and modify his or her subsequent behavior.202 fmri data revealed heightened activity in the drinkers’ left amygdala, suggesting increased sensitivity to affective information, and heightened activity in the insula, correlating with impulsivity and risky decision-making.203 no difference in cognitive control areas204 was observed, but the scientists hypothesized that this could result from a lack of study power or the limited research subject sample.205 overall, this study suggested that many of the primary decision-making difficulties faced by adolescents correlate with binge drinking. the results studies suggest that the relationship between comparatively poor decision-making and alcohol consumption run in both directions: adolescents who initially scored lower than their peers on several dimensions of emotional control, but who were not yet binge drinkers, were more likely to report subsequent binge drinking.206 200 see id. at 406. 201 see lin xiao et al., abnormal affective decision making revealed in adolescent binge drinkers using a functional magnetic resonance imaging study, psychology of addictive behaviors 1, 7 (2012). 202 the igt is used to assess deficits in a variety of clinical populations, ranging from subjects that are addicted to those suffering from lesion injuries, traumatic brain injuries, and mental illnesses. julie a. suhr & melissa t. buelow, construct validity of the iowa gambling task, 19 neuropsychol. rev. 102, 102 (2009). 203 xiao et al., supra note 201, at 8. 204 including the orbitofrontal cortex (ofc) and ventromedial prefrontal cortex (vmpc). 205 see xiao et al., supra note 201, at 9. 206 c. anderson johnson et al., affective decision-making deficits, linked to a dysfunctional ventromedial prefrontal cortex, revealed in 10th grade chinese adolescent binge drinkers, 46 neuropsychol. 714, 721-22 (2008). http://dx.doi.org/10.1037/a0027892 http://dx.doi.org/10.1007/s11065-009-9083-4 http://dx.doi.org/10.1016/j.neuropsychologia.2007.09.012 2015 575 how developmental neuroscience can inform legal regimes governing adolescents conversely, adolescents who engaged in binge drinking performed more poorly on tests of emotional regulation.207 this suggests that the relationship between adolescence and binge drinking is not entirely age-dependent. some adolescents have relatively greater or lesser emotional selfregulation, and relatively greater or lesser susceptibility to temporal discounting and sensation-seeking. in other words, adolescents are individuals, too; it is not the case that all adolescents are equally at risk.208 however, since these vulnerabilities are more common in adolescents, and since the maturation process typically resolves these vulnerabilities in most normal individuals, a blanket prohibition on activities that key into and exacerbate them would appear to be indicated. is this an instance where we can move from a factual “is” to a policy “ought”? that is, do the set of biological and social facts about juvenile developmental vulnerabilities in relation to substance misuse tell us that we ought not to have a rehabilitation-focused regime rather than a deterrence-focused criminal regime? the relationship between adolescent vulnerabilities to substance misuse, and the significant internal and external harms of substance misuse, raises more provocative questions for law than does the case of tattooing. it is still the case that no one role for law is dictated by the biological findings and social facts of adolescent substance misuse; yet, the biological and social facts suggest that certain legal regimes would be more prudent and more efficient than others in achieving the normative goals of harm reduction. there may be a dual role for law: strong regimes of prohibition on the front end, followed by—perhaps counterintuitively—lenient or rehabilitation-focused regimes on the back-end. as teens are particularly susceptible to the negative effects of alcohol and drugs of abuse, they similarly have less control over whether they become addicted to these substances and over the ways in 207 see id. at 722-23. 208 casey & jones, supra note 187, at 1197 (discussing how variable factors like alcohol dependence in the family can affect an individual adolescent’s risk profile). 576 indiana health law review vol. 12:2 which these substances affect their behavior. this suggests that strongly punitive regimes aimed at deterrence will be costly for the state, yet achieve little; teens are less likely to weigh the prospect of future punishment relative to immediate reward.209 the vulnerabilities of impulsivity and temporal discounting that make them more likely to make bad initial choices around alcohol and drugs, and to become addicted to alcohol or drugs, are the same vulnerabilities that make them relatively punishment-insensitive. the typical teen is even less likely than the typical adult to weigh the prospect of future punishment against immediate reward and be deterred by it.210 we similarly might expect even poorer judgment and self-control from an addicted teen than from an addicted adult, irrespective of punishment regimes.211 thus, punitive deterrence regimes aimed at teens in this arena are likely to result in high spending by the state for little impact, while producing significantly negative secondary effects as teens are processed through the criminal justice system.212 and, although they are more vulnerable to the negative effects of these substances, they are more susceptible to rehabilitation.213 in considering whether juveniles should be dealt with via criminal justice system or via diversionary and treatment programs, there is a strong case that addicted juveniles need diversionary interventions to protect their developing brains from the further effects of alcohol and drugs of abuse.214 209 see supra part ii.d. 210 see reyna & farley, supra note 190. 211 see bava & tapert, supra note 183, at 405-06 (explaining that drug and alcohol abuse damages cognitive capacities integral to decision making above and beyond the neurological challenges adolescents already face). 212 see, e.g., jasmine l. tyler et al., cost effective corrections: the fiscal architecture of rational juvenile justice systems, the justice pol’y inst. (2006), available at http://www.justicepolicy.org/uploads /justicepolicy/documents/06-03_rep_costeffective_jj.pdf. 213 see 560 u.s. 48, 74 (2010) (describing adolescent offenders as “most in need of and receptive to rehabilitation.”). 214 see david gottesman & susan wile schwarz, juvenile justice in the u.s.: facts for policymakers, nat’l ctr. for children in poverty 4 (2011), available at http://www.nccp.org/publications 2015 577 how developmental neuroscience can inform legal regimes governing adolescents drinking and drug use hit many of the same vulnerabilities as tattooing. among them are sensation seeking, impulsivity, temporal discounting, peer influence, and the ability both to fit in and rebel.215 but the differences with drinking and drug use are that they can alter the structure and function of the developing brain, can make a person more prone to substance misuse disorders in adulthood, and can exacerbate the mood swings and depression to which teens already are prone.216 do these factors in themselves argue for legal intervention and prohibition? not necessarily. one could take the libertarian position (presented above, with tattooing) that these problems are the concern of the individual affected but are not properly the concern of the state.217 the key difference, however, between the case of tattooing and the case of addictive substances is that the case for legal prohibition need not rest on aesthetic paternalism alone. rather, unlike tattooing, substance misuse and abuse by adolescents can create significant, harmful externalities,218 and provide a clear role for law in protecting adolescents and other social stakeholders. thus, here, neurodevelopmental information provides more guidance to the law than it does in the case of tattooing: prohibiting tattooing is a paternalistic and aesthetic choice on the part of the law. we understand that teens are more vulnerable to making bad decisions about tattooing, but they may be at risk of making bad decisions in many areas; whether to regulate any one versus any other stems in part from the permanence of tattoos but largely from the residual social stigma that hangs over them. with addictive substances, the forms of harm present a stronger case for regulation under most dominant views of what the law is intended to accomplish: drug abuse can /pdf/text_1038.pdf (explaining that community-based services, such as rehabilitation, better serve the needs of adolescents and society than other forms of juvenile incarceration). 215 see supra part ii. 216 see bava & tapert, supra note 183, at 403, 405-06. 217 see supra note 175. 218 see supra note 184. 578 indiana health law review vol. 12:2 lead to long-term developmental harm for the youth, there is little or no socially positive or expressive value to the activity (unlike tattooing, which can be a form of artistic self-expression, protected by the first amendment), it creates externalities relating to the harms that the adolescent or future adult addicts can cause, and it can create long term costs to the state, including healthcare cases and heightened risks of future incarceration. c. intentional violence the case of intentional violence by adolescents presents different challenges for the law than the cases of tattooing and of addictive substances like tobacco and alcohol. although tattooing and the use of addictive substances can present risks to the individual and create negative externalities, they are not all necessarily negative in themselves: alcohol219 or marijuana220 can be used moderately for pleasure and recreation; tattoos can have self-expressive meaning.221 intentional violence, however, is a core form of criminal behavior that necessarily inflicts harms on others. also, unlike experimentation with alcohol or other moderately risky behaviors, engaging in intentional violence—particularly serious intentional violence—is not a typical developmental experience for adolescents.222 this short section considers what, if anything, developmental 219 see alcohol use: if you drink, keep it moderate, mayo clinic (feb. 11, 2014), http://www.mayoclinic.org/healthy-lifestyle/nutritionand-healthy-eating/in-depth/alcohol/art-20044551. 220 see dirk w. lachenmeier & jurgen rehm, comparative risk assessment of alcohol, tobacco, cannabis, and other illicit drugs using the margin of exposure approach, 5 scientific reports 1 (2015) (showing that cannabis poses a low risk of toxicity when comparing typical human dosages with dosages shown to be fatal in animal studies). 221 see mark b. stephens, behavioral risks associated with tattooing, 35 fam. medicine 52, 52 (2003). 222 see adolescence, brain development and legal culpability, aba juvenile justice ctr. 3 (2004) (explaining that childhood exposure to trauma is predictive of violence in adolescence. this suggests that adolescent violence arises in the wake of external, environmental factors, not as a natural part of brain development.). http://dx.doi.org/10.1038/srep08126 2015 579 how developmental neuroscience can inform legal regimes governing adolescents neurobiology can tell us relative to adolescents’ commission of intentional violence. we do not attempt to treat this important subject thoroughly here; instead, we are using the case of intentional violence to consider the relationship between developmental neurobiology and various contexts in which intentional violence could occur, for the purpose of showing how the conduct that may appear superficially the same can have very different implications relative to developmental maturity and the ability to engage in empathy, judgment, and self-control. in this section, we contrast two cases of intentional violence to demonstrate the ways in which an approach informed by developmental neurobiology would differ from current criminal law. both cases present scenarios of a fifteen-year-old boy committing a battery that results in serious bodily harm. under existing criminal law, the perpetrators in both cases likely would be waived into the adult system and tried as adults based on the nature of the crime and the level of harm that they caused. however, in the first case, the adolescent is in a context that implicates many adolescent vulnerabilities, while in the second, the adolescent has the opportunity to exercise more considered and adult-like judgment. if law aims or intends to discriminate between juvenile and adult conduct, and to provide some mitigation for adolescents based on their vulnerabilities, then the law ought to treat the perpetrators in these two scenarios differently. we conclude that the law currently overvalues the nature of act itself and the harm caused by the act when weighing the criminal consequences that a juvenile should face. it is in the criminal area that the law most crudely and inappropriately divides juvenile from adult responsibility, by imposing adult liability on adolescents based on whether their actions caused great harm rather than by evaluating whether the actions were the product of mental processes that could be called “responsible” by an adult standard.223 indeed, the ways in which the law draws the responsibility line between juveniles and adults is 223 see hudson, supra note 17. 580 indiana health law review vol. 12:2 frequently by reference to inappropriate or even irrelevant criteria. instead, we argue that the law ought to consider the nature of the act relative whether the context in which it occurred triggered or implicated adolescent vulnerabilities. a juvenile is neither necessarily responsible nor necessarily nonresponsible for an act of violence; the real question, we suggest is: “could we expect the typical adolescent to act with sufficient maturity and judgment in the context in which the act occurred such that he or she could be considered the equivalent of an adult under the circumstances?” 1. scenario a: vulnerable to violence consider a fifteen-year-old teenager who lives in a gangridden neighborhood and is pressured to join a gang. joining the gang presents some dangers—but so does refusing to join. initiation requires “shanking”—or stabbing—a member of a rival gang. egged on by friends and senior gang members, he stabs another boy in the leg. the blade hits the femoral artery and the victim nearly dies, but is saved by timely medical assistance. in most jurisdictions, this adolescent would be waived into the adult system and tried as an adult—possibly for attempted murder but at least for aggravated battery.224 his gang membership may even be an aggravating factor in his charging and sentencing. but should that be the case? youth participation in gang activity has increased dramatically in the united states over the last twenty-five 224 issue brief 3: less guilty by reason of adolescence, macarthur found. research network on adolescent development and juvenile justice, http://www.adjj.org/downloads/6093issue_brief_3.pdf (last visited may 17, 2015); issue brief 5: the changing borders of juvenile justice: transfer of adolescents to the adult criminal court, macarthur found. research network on adolescent development and juvenile justice, http://www.adjj.org/downloads/3582issue_brief_5.pdf (last visited aug. 12, 2015). 2015 581 how developmental neuroscience can inform legal regimes governing adolescents years.225 youth gangs comprise loosely connected social networks and have a high turnover;226 most teens remain in a gang for only a year or two.227 experts disagree over how to define gangs; some focus on the fundamental role of crime in group identity228 whereas others look to “shared identity, solidarity and identified territory” as defining characteristics.229 still others rely on self-reported gang membership to determine when an association constitutes a gang.230 youth gang membership is strongly correlated with violent, criminal activity.231 studies show that adolescents commit substantially more violent crimes during gang membership than before and after,232 supporting the “facilitation” model of transient gang membership.233 the facilitation model holds that gangs promote criminal behavior as opposed to attracting and selecting individuals 225 kate o’brien, et al., youth gang affiliation, violence, and criminal activities: a review of motivational, risk, and protective factors, 18 aggression violent behav. 417, 418 (2013). 226 id. at 419. (explaining the contrast between reality and the stereotype of highly organized, stable gangs: “research suggests that while this may be true for some, in most street gangs ‘leadership is ephemeral, turnover is often high, and cohesiveness only moderate and many street gangs are more a loose connection of cliques or social networks than a single, coherent whole.’”) (citations omitted). 227 id. (“most youth who identify themselves as gang members report remaining in gangs for less than 4 years, with most being members for between 1 and 2 years.”) (citations omitted). 228 see malcolm w. klein & cheryl l. maxson, street gang patterns and policies 4-10 (2006). 229 o’brien et al., supra note 225, at 418. (citation omitted). 230 id. 231 id. (explaining that the extent to which an individual reports being associated with a gang correlates with the level of criminal activity that individual participates in. for example, self-identified current gang members participate in more crime than individuals who have friends in gangs, and individuals not associated with gangs at all participate in even less crime). 232 terence p. thornberry et al., the role of juvenile gangs in facilitating delinquent behavior, 30 j. res. crime & delinquency 55 (1993). 233 o’brien, supra note 225, at 419-20. http://dx.doi.org/10.1016/j.avb.2013.05.001 http://dx.doi.org/10.1177/0022427893030001005 582 indiana health law review vol. 12:2 already prone to delinquency.234 risk factors in numerous domains (individual, family, peer, school, and community) predict an adolescent’s eventual gang membership and violent criminal activity.235 these domains overlap with the unique vulnerabilities of the developing brain, especially with respect to peer influence and identity formation. peer groups like gangs strongly influence teenage beliefs and values through repeated exposure to the group’s accepted normative structures and by reducing exposure to alternative models.236 acceptance and approval within a group plays into teens’ overvaluation of affective information, and social alienation has been found to be a risk factor for gang membership and violence.237 thus gangs can provide a source of social status, respect, and friendship, especially for individuals in socioeconomic life situations that lack structured, pro-social group activities.238 at the individual level, gang membership and youth violence have been correlated with emotional reactivity, impulsivity, sensation-seeking, and risk taking.239 studies show that youth tend to leave gangs as they age and 234 marvin d. krohn & terence p. thornberry, longitudinal perspectives on adolescent street gangs, in the long view of crime: a synthesis of longitudinal research 128-60 (akiva m. liberman ed., 2008); but cf. rachel a. gordon et al., antisocial behavior and youth gang membership: selection and socialization, 42 criminology 55 (2004) (suggesting that a synthesis of facilitation and selection governs gang membership, based on data showing that prior to joining a gang, youth often already engage in criminal activity, which increased during gang membership.). 235 o’brien, supra note 225, at 420. 236 see klein & maxson, supra note 228, at 4; david c. pyrooz et al., continuity and change in gang membership and gang embeddedness, 50 j. res. crime & delinquency 239 (2012). 237 o’brien, supra note 225, at 421. 238 see also emma alleyne & jane l. wood, gang involvement: social and environmental factors, 60 crime & delinquency 547 (2014); nat’l research council of the nat’l acads., reforming juvenile justice: a developmental approach 105-06 (2013). 239 see klein & maxson, supra note 228, at 4; o’brien, supra note 225, at 421. http://dx.doi.org/10.1111/j.1745-9125.2004.tb00513.x http://dx.doi.org/10.1177/0022427811434830 http://dx.doi.org/10.1177/0011128711398029 2015 583 how developmental neuroscience can inform legal regimes governing adolescents mature,240 supporting the notion that the neurological vulnerabilities that dissipate as a teenager grows out of adolescence predispose youth to gang membership. our hypothetical teen lives in a perfect storm of neurological and socioeconomic risk factors for gang membership and associated violence. gangs are peer pressure mechanisms. they play into all of the age-typical adolescent neurological vulnerabilities: temporal discounting or the “short future”; impulsivity; poor risk/reward calculations that overvalue positive (even if unlikely) payoffs; discounting negative outcomes, even highly likely negative outcomes; the need for peer approval; and the use of the social group for identity formation.241 gang membership provides companionship and status as well as exciting, if short-sighted, opportunities for gaining recognition and respect in the community.242 adolescents who experience poor-quality or absent parental modeling, poverty, and low quality schools are especially at risk.243 they may also be violently pressured to join gangs or know that they will be the gang’s victims if they are not its members.244 under the pressure of peer influence and the lack of alternatives (or lack of ability to perceive and access alternatives), joining and participating in a gang could feel inexorable. nonetheless, the consequences of his initiatory act of violence are severe. the victim was seriously injured and could have died. additionally, the teen now faces severe legal penalties that may change the course of his life. under the principle of “adult crime, adult time,” a juvenile can be waived into the adult criminal justice system when he causes a certain level of harm.245 accordingly, penalties 240 ross hastings et al., leaving criminal youth gangs: exit strategies and programs (2011). 241 see supra part ii. 242 see o’brien, supra note 225, at 422. 243 see id. at 421. 244 see straight talk about youth gangs: facts for educators, nat’l crime prevention council 1, http://www.ncpc.org /programs/teens-crime-and-the-community/publications-1/adult2-pdf (last visited aug. 12, 2015). 245 see hudson, supra note 17. 584 indiana health law review vol. 12:2 can include life without parole and, until the 2011 roper decision, even the death penalty.246 should these policies take into consideration the unique neurological deficiencies of adolescents? in graham, the supreme court found that for non-homicide crimes, the purposes of punishment do not apply as strongly to juveniles: impulsivity and poor risk-reward calculations make deterrence likely to fail; that since juveniles are still developing, rehabilitation is a real possibility and they need not be incapacitated for life; and that retribution simply does not support life without parole for juveniles.247 2. scenario b: deliberate violence now consider a same-age adolescent who lives in an affluent suburb and goes to a prosperous public high school. he begins dealing marijuana and prescription drugs at his school, making thousands of dollars a month. he learns that another boy in his class plans to turn him into the school principal. to prevent the other boy from turning him in, and to make a statement to any other students who might do the same, he stabs this boy in the leg – hitting the femoral artery and nearly killing him, but for timely medical intervention. this situation involves a serious, violent homicide crime, just like the first scenario. but it does not implicate the same adolescent neurological vulnerabilities. unlike the peer pressure involved in joining and participating in a gang, this adolescent acted independently. he neither had peers directly pressuring him to engage in violence nor would his identity in his community be placed at risk if he failed to commit a violent act, particularly since he lives in a community that does not valorize (or require) violence. his act was not impulsive: he deliberately planned the attack for the rational purpose of preserving his business. moreover, the act is not one that is rewarding in itself (for typical individuals), so the typical teen overvaluation of positive reward also is not operative here. some typical 246 see supra part i.a. 247 see 560 u.s. 48 (2010); see supra part i.a. 2015 585 how developmental neuroscience can inform legal regimes governing adolescents adolescent vulnerabilities may have contributed to his decision; temporal discounting may be at work, as he may not appreciate the impact his act could have on his own— and his victim’s—future. he also has a teen’s typical psychosocial and experiential limitations, and a teen’s (average) greater ability to be rehabilitated. nevertheless, his decision and action did not arise in a context that causes the typical adolescent to make poor decisions. plausible arguments for mitigation based on his age could be made, but here the weight of neurobiological factors would suggest that, in this context and on these facts, the adolescent is not significantly different from the adult. v. recommendations & conclusion what we see in the various regimes governing adolescent conduct are a set of approaches to balancing stakeholder interests but that share a feature in common: the notion that adolescents lack judgment generally.248 in some areas, adolescents are allowed to exercise limited or conditional autonomy, but often less because the law deems them to be responsible decision-makers than for reasons of social expedience: allowing adolescents to work, for example, is historically rooted in traditional agrarian practices and remains important to the economic wellbeing of many families today.249 where adolescents are endowed by law with adult-like responsibility, the law may do so without considering the qualities of the adolescent; rather, the law considers the culture’s overall normative judgment about the act. to be more clear: the criminal law imposes adult responsibility on adolescents when adolescents cause significant harm—harm that mandates, normatively, strong moral condemnation, which we conventionally express through criminal punishment.250 we engage in motivated 248 see supra part ii (describing the adolescent brain’s neurological limitations on decision making). 249 see david h. wegman et al., protecting youth at work: health, safety, and development of working children and adolescents in the united states, nat’l academies press 146, 151 (1998). 250 see hudson, supra note 17. 586 indiana health law review vol. 12:2 reasoning about whether the juvenile was acting as a juvenile or as an adult, reasoning that supports our intuitive desire to allow or to punish particular activities, not our rational assessment of the degree of the juvenile’s ability to engage in mature reasoning and conduct relative to the particular domain under consideration. but adolescents are not uniformly lacking judgment across the board. nor are they more responsible and mature in the areas in which the law imposes adult-like responsibility or culpability upon them. instead, juveniles mature in uneven ways.251 they have particular strengths and particular disabilities. these strengths and disabilities may be entirely independent of whether the adolescents cause harm to themselves or others. indeed, juveniles may be particularly nonresponsible—in a developmental sense— relative to the actions that have the capacity to cause the greatest harm. teens are, by virtue of age and immaturity, most likely to engage in reckless driving, reckless drinking, reckless sex, and reckless use of violence. these are all areas in which adult like responsibility may be imposed on them—from freedom to marry, to freedom to drive, to full adult criminal responsibility for causing serious bodily harm or death. in tandem with the findings of juvenile developmental neurobiology, legal regimes should balance the interests of other stakeholders and the capacities of the various institutions that are implicated in particular legal regimes. we suggest that lawmakers can impose some discipline on the process of making laws for juveniles and balancing the interests of stakeholders and the capacities of institutions by adopting an explicit use of a matrix. we suggest that lawmakers think of the relationship between juvenile neurodevelopmental factors, legal and social norms, stakeholder interests, and institutional considerations, as relating in the following way: imagine a set of juvenile capacities and vulnerabilities on one axis of a matrix. the other axes of the matrix consist of the interests of other stakeholders, the capacities of institutions, the presence of 251 see supra part ii (describing how the subcortical and cognitive control systems mature at different times and rates). 2015 587 how developmental neuroscience can inform legal regimes governing adolescents important or controlling social norms, and the signaling function of the law. like the neurodevelopmental information itself, the matrix does not determine the particular outcome. rather, it allows for clarity about the choices and trade-offs within any particular legal regime. this moves us away from an insufficiently granular, and often unproductive, discourse about whether juveniles are, or are not, sufficiently responsible to have a particular legal form of autonomy or responsibility. instead, there can be a multidimensional assessment of juvenile capacities in relation to the needs and rights of other stakeholders and the broader societal norms and concerns that animate the need or desire for a legal regime in the first place. we do not purport to construct here the definitive matrix of all the legal, social, and stakeholder concerns that lawmakers or policymakers might analyze. the neurodevelopmental criteria are the clearest. these are provided by the science of juvenile brain development, and include the various juvenile vulnerabilities discussed throughout this paper. the legal and normative criteria are less definite and more contingent, but several criteria on each dimension may be relatively uncontroversial and shared across legal and social contexts. on the dimensions of stakeholder interests and institutional capacities, a decision matrix might include, e.g., whether the issue implicates a parent’s right to determine the child’s upbringing; whether a parent or institution could suffer civil or criminal liability for the juvenile’s action; and whether an institution has an interest in controlling the behavior in question for purposes of maintaining order (as in a school setting). on the normative dimension, a decision matrix might include factors such as, e.g., whether the behavior creates significant externalities or risks to others; social or conventional moral attitudes toward the behavior; the importance of the liberty or privacy interests implicated by the activity; or any of numerous other potential normative concerns. the strongest case for prohibitive or protective regulation would exist where the action or behavior that would be regulated by law: 588 indiana health law review vol. 12:2 • significantly implicates one or more typical adolescent neurodevelopmental vulnerabilities; • creates significant costs or risks for other stakeholders; • impinges on a parent’s right to direct the upbringing of the child to a greater degree than it allows for the adolescent to engage in expressive autonomy or self-creation, and/or does not have significant expressive autonomy meaning for the adolescent; and • is normatively undesirable in itself. the weakest cases for prohibitive or protective regulation would exist where the action or behavior that could be regulated by law: • does not significantly implicate one or more typical adolescent neurodevelopmental vulnerabilities because, for example, it concerns an area where the teen is not subject to peer influence or where there is not positive risk-taking or positive reward that is unduly attractive; • has minimal impact for other stakeholders; • does not impinge, or only limitedly impinges, on a parent’s right to direct the upbringing of the child; • the activity or behavior may be an important component of self-development, autonomy, or identity formation; and • is at least normatively neutral. taking this idea of the matrix, we can re-evaluate the several cases discussed in the part above and ask whether the structure of the legal regimes and the related legal outcomes should be different. with each of these cases— and, indeed, with any legal issue—we can ask not just “are juveniles sufficiently responsible to engage in, or to be punished for, for x activity?” instead, we can disaggregate what “responsibility” means and ask, “does this activity implicate the particular vulnerabilities of juveniles, 2015 589 how developmental neuroscience can inform legal regimes governing adolescents suggesting a role for legal limits? if so, what are the other relevant normative and institutional considerations that may shape whether the activity is regulated and the form that the regulation takes?” after analyzing the target behavior on a matrix that allows us to cross-evaluate neurodevelopmental, legal, and normative considerations, a result might emerge that some form of legal control or regulation would be prudent. the question then remains, “what should the law do?” there are, generally, three choices: the law may prohibit, protect, or punish. the law may prohibit juveniles from smoking tobacco (and punish those who sell it to juveniles, not punish juveniles themselves for smoking). the law may protect juveniles from working more than a certain number of hours, or may protect them from the sexual advances of adults. and the law may punish juveniles for breaking criminal laws and causing harm to others, either less than or the same as it punishes adults. our proposed matrix (we suggest) indicates where legal regulation may be called-for. normative criteria, not neurodevelopmental ones, set the agenda for whether the law will protect, prohibit, or punish. considering neurodevelopmental factors in tandem with the law’s normative purposes, though, can nevertheless help determine whether a particular legal regime is consonant with its stated purposes or whether it inadvertently works at cross-purposes with its own aims. juveniles’ capacities, their strengths and weaknesses, can inform the law to create regimes that are tailored to better effectuating the law’s purposes. developmental neurobiology is one, and only one, aspect of creating legal regimes that are appropriate to how adolescents really are—how they are in their bodies and brains and social experience. all areas in which some aspect of the law rests upon assumptions about what humans are like—how mature we are, how responsible we are, what kinds of decision-makers we are, what capacities we have—can be informed, although not determined, by neuroscientific information. using neurodevelopmental information to help craft legal regimes for adolescents is a model or microcosm for how more generally to craft regimes that integrate 590 indiana health law review vol. 12:2 neurodevelopmental and neuroscientific information. neither juveniles, nor any other subject of the law, exist in isolation; all are components of webs of relationships and of sets of stakeholder and institutional interests, each of which should be understood with clarity so that the law as it exists is aligned with its purposes. i. introduction ii. legal regimes constraining adolescent autonomy: a typology a. recent supreme court holdings recognize juvenile developmental difference b. a typology of legal approaches to adolescent autonomy and responsibility 1. total denials of autonomy 2. delegated autonomy 3. graduated autonomy 4. total autonomy 5. censure-based responsibility c. the result—multiple regimes lead to inconsistent outcomes iii. how – and why – adolescents are different a. the brain’s adolescence b. developmental disparity between pfc and limbic system c. emotional control and reactivity d. reward and impulsivity iv. three cases of juvenile law analyzed via neurodevelopmental criteria a. the case of tattooing b. the case of alcohol, tobacco, and other addictive substances c. intentional violence 1. scenario a: vulnerable to violence 2. scenario b: deliberate violence v. recommendations & conclusion accountability partners: legislated collaboration for health reform accountability partners: legislated collaboration for health reform mark t. morrell and alex t. krouse' i. introduction .................................... 226 ii. patient accountability ................... ...... 236 a. shifting role ofphysician-patient rela tionshio....... 237 b. accountability for rising patient care costs............ 239 c models of cost containment before the affordable care act ............................. ...... 241 d. accountability to patients for cost containment under affordable care act....................... 244 e. toward patient-centered medicine and consumer driven choices ........................ ..... 245 f patient-centered medical home model..... ..... 247 g. patient-centered outcomes research institute ....... 248 h. promoting accountability in personal healthcare decisions ............................ ...... 249 iii. community accountability....................... 252 a. community health centers ................... 254 b. transitioning patients from hospitals back to the community . ........................ ......... 259 c. accountability of exempt hospitals to their communities............................... 263 iv. accountability to government .................. 268 a. health insurer accountability............ ............. 269 b. fraud and abuse promoting accountability ............. 275 c physician accountability and conflicts of interest ... 280 v. accountability among providers ................ 284 a. a brief history-u s. health system as a fragmented 1 mark t. morrell is a healthcare attorney in franklin, tennessee. mr. morrell graduated from ball state university with a degree in finance (1997), and from regent law school with a juris doctor (2001). he is licensed to practice law in indiana, virginia and washington, d.c. alex t. krouse is a healthcare attorney with the firm of krieg devault, llp, located in mishawaka, indiana. mr. krouse graduated from depauw university with a degree in history (2008) and from indiana university with both a juris doctor and a master in health administration (2012). indiana health law review model. ............................ ...... 284 b. promoting accountability among providers ............. 288 c. strengthening 'primary care"........ .......... 289 d. payment models promoting accountability among providers............................... 293 e. organizational accountability ........... ..... 295 vi. conclusion .......................... ....... 300 i. introduction the term "accountability partner" carries various meanings, depending on the context. it is sometimes associated with weight loss and fitness, as depicted on the reality television show the biggest loser.2 in financial planning, the term means someone who is responsible for overseeing the spending of another.3 the term can refer to an individual who is assigned to assist a prisoner before the prisoner's release back into the general population. 4 in its 2 in 2013, nbc included the biggest loser in its lineup for its fourteenth season in primetime television. see the biggest loser all bios, nbc, http://www.nbc.com/the-biggest-loser/about/ (last visited dec. 26, 2013). as a spinoff to the television show, the website http://www.biggestloser.com/ provides tips for sustaining weight loss, including use of accountability partners. see also amy parham, 10 lessons from a former fat girl 41 (2010) (former contestant on the biggest loser discussing use of an accountability partner). for other examples of accountability in weight loss and fitness, see heather caliendo, tulsa tough founder peddles ftness, j. rec. (jan. 23, 2009), http://journalrecord.com/2009/01/23/tulsa-tough-founder-peddlesfitness/; diane carbonell, weight loss tracker program, livestrong.com, http://www.livestrong.com/article/295435-weight-losstracker-program/#ixzz1ddn1w9ik (last updated oct. 21, 2013). 3 see, e.g., myriam digiovanni, forum basks in success of saveltup program and gears up for next year, credit union times (nov. 18, 2009), http://www.cutimes.com/2009/11/18/forum-basks-insuccess-of-saveitup-program-and-gears-up-for-next-year. 4 see, e.g., lynn s. branham, the mess we're in: fyve steps towards the transformation of prison cultures, 44 ind. l. rev. 703, 724 (2011). 226 vol. 11:1 accountability partners most general sense, the term "accountability partner"5 means a person who agrees to accept responsibility and account for another's actions with the purpose of achieving specific, identifiable behavioral goals such as abstinence, temperance, financial stewardship, or avoidance of addictions.6 following enactment of the patient protection and affordable care act (the "affordable care act") in march 6 our description of the term "accountability partner" incorporates a portion of the dictionary definition of the word "accountability." accountability definition, merriam-webster, http://www.merriam-webster.com/dictionary/accountability (last visited august 15, 2013) ("the quality or state of being accountable; especially: an obligation or willingness to accept responsibility or to account for one's actions."). 6 carol sanger, infant safe haven laws: legislating in the culture of life, 106 colum. l. rev. 753, 816-817 (2006) ("[m]embers wear silver rings 396 and exchange pledges of abstinence with "accountability partners."); karen crouse, the clean and sober batting champion, n.y. times, oct. 30, 2010, at d1 (discussing josh hamilton's battle with temptation regarding drugs and alcohol and his reliance on "a great accountability partner on the road"); john leland, the other porn addicts, n.y. times, may 3, 2010, at a13 (use of a workbook that "emphasizes prayer, christian fellowship and the use of 'accountability partners' to hold the users to high standards of abstinence"); michelle singletary, sink your teeth into a fast, a financial fast, that isthree weeks of buying what you need but forgoing the things you merely want, wash. post, jan. 3, 2010, at g01, ("men and women who are good stewards over their personal finances become accountability partners for members who are struggling"); stephanie simon, learning to write their love, l.a. times, nov. 24, 2005, at al ("many congregations assign men "accountability partners" to keep them on track in love and life."); jill sundby, state bar news: at the annual meeting: mcshane's helping montana lawyers tune up their lives' anthems, 26 mont. law. oct. 2000, at 18, 20 ("set up a timeline and have an accountability partner to see that you do it."); michael staver, nine good ways to avoid burnout, principal's rep., may 2006, at 9, 9 ("get an 'accountability partner' to help you stay focused."); ben g. pender ii, symposium: financial compliance, regulation, and risk management: invigorating the role of the in-house legal advisor as steward in ethical culture and governance at clienthusiness organizations: from 21st century failures to true calling, 12 duq. bus. l.j. 91, 124 (2009) ("the legal advisor as truth-teller is not the pejorative tattletaler/whistleblower. rather, such a counsel is a trusted advisor, team player, and accountability partner."). 2014 227 indiana health law review 2010,7 the popular discussions and attention-grabbing headlines8 contained within the 400,000 words and 900 pages9 of laws and regulations centered around a few repeated, contested issues. pundits and politicians debated the merits of the "individual mandate," which requires individuals to purchase health insurance and threatens financial penalties for those who refuse.10 americans were (and continue to be) philosophically divided about whether individual consumers should be required to obtain health insurance." many question whether the government has 7 patient protection and affordable care act of 2010, pub. l. no. 111-148, 124 stat. 119-1025 (2010) (amending title xviii of the social security act, 42 u.s.c. § 1395 et seq., by adding new § 1899) was amended by the health care and education reconciliation act of 2010, pub. l. 111-152, 124 stat. 1029-84 (2010). the final amended legislation will be referenced throughout this article as the "affordable care act." 8 see, e.g., edward zelinsky, the individual mandate won't work, huff post politics: the blog (july 3, 2012, 1:16 pm), http://www.huffingtonpost.com/edward-zelinsky/the-individualmandate-wo b_1646791.html; nina owcharenko, the case against obamacare: health care policy series for the 112th congress, heritage found. (nov. 9, 2010), http://thf media.s3.amazonaws.coml 201 1/pdflthecaseagainstobamacare.pdflee sheppard, the unconstitutional individual mandate, forbes (sept. 30, 2010, 4:00 pm), http://www.forbes.com/2010/09/30/health-care-mandate-opinionscolumnists-lee-sheppard.html; but see, e.g., laura chapin, republicans are hypocrites on healthcare individual mandate, u.s. news: news opinion (dec. 17, 2010), http://www.usnews.com/opinion/blogs/laurachapin/2010/12/17/republicans-are-hypocrites-on-healthcare-invidualmandate. 9 varying public reports about the length of the affordable care act ranged from 900 to 2700 pages and from 300,000 to 420,000 words. see, e.g., tom giffey, is 'obamacare' really that long?, leadertelegram (july 17, 2012, 2:01 pm), http://www.leadertelegram.com/blogs/tom__giffey/articlec9flfa54-d04111el-9d01-0019bb2963f4.html. 10 26 u.s.c. § 5000a (2013). subtitle f of the affordable care act is aptly titled in common accountability terms: "shared responsibility for health care." 11 in two separate 2012 gallup polls, approximately half of americans supported the affordable care act, and approximately half would like to see it overturned. see lydia saad, americans issue split decision on healthcare ruling, gallup politics (june 29, 2012), 228 vol. 11:1 accountability partners the constitutional authority to require an american to buy health insurance. 12 when the united states supreme court effectively upheld the individual mandate under the federal government's authority to enact a tax, it affirmed that americans would be held accountable for obtaining their own health insurance.13 the supreme court decided that although the individual mandate is impermissible under the constitution's necessary and proper clause,14 the requirement for nearly all americans to secure insurance beginning in 2014 is permissible under congress's taxing authority.1s despite the finality of the supreme court's decision, the ruling did not eliminate the ongoing debate about the merits of the affordable care act or the constitutionality of the individual mandate.' 6 the http://www.gallup.com/poll/155447/americans-issue-split-decisionhealthcare-ruling.aspx?utmsource=alert&utmmedium=email& utmcampaign=syndication&utmcontent=morelink&utmterm=all%20 gallup%20headlines%20-%2opolitics; jeffrey m jones americans divided on repeal of 2010 healthcare law, gallup politics (feb. 27, 2012), http://www.gallup.com/poll/152969/americans-divided-repeal2010-healthcare-law.aspx. 12 see e.g., terence p. jeffrey, sen. hatch questions constitutionality of obamacare: if feds can force us to buy health insurance 'then there's literally nothing the federal government can't force us to do,' cnsnews.com (nov. 1, 2009), http://cnsnews.com/node/56447. id.; see also william dunkelberg, the supremes deal a blow to small business, forbes (june 28, 2012, 5:48 pm), http://www.forbes.com/sites/groupthink/2012/06/28/the-supremesdeal-a-blow-to-small-business/. 13 nat'l fed'n of indep. bus. v. sebelius, 132 s. ct. 2566 (2012). 14 id. at 2592 ("[tlhe individual mandate cannot be sustained under the necessary and proper clause as an essential component of the insurance reforms. each of our prior cases upholding laws under that clause involved exercises of authority derivative of, and in service to, a granted power.)" 15 id. at 2600 ("the affordable care act's requirement that certain individuals pay a financial penalty for not obtaining health insurance may reasonably be characterized as a tax. because the constitution permits such a tax, it is not our role to forbid it, or to pass upon its wisdom or fairness.") 16 see, e.g., jason fodeman, the new health law: bad for doctors, awful for patients, institute for healthcare consumerism, http://www.theihcc.com/en/communities/policylegislation/the-new2014 229 indiana health law review continued existence or possible repeal of the affordable care act was central to the 2012 presidential election.17 in connection with the individual mandate, the affordable care act established a federal healthcare insurance exchange to be a marketplace for making low-cost insurance available to all.18 in other words, those who are being held accountable for buying insurance coverage would be offered the opportunity to obtain insurance from these exchanges at an affordable rate. in this way, the government is holding itself accountable to the uninsured consumer. the insurance exchanges, which must be operating in states by january 1, 2014, are expected to be a primary way that the previously uninsured will be able to access affordable insurance coverage to comply with the individual mandate.' 9 while the exchanges will be a major way that as many as thirty million people will obtain health-law-bad-for-doctors-awful-for-patie gnl7yolk.html (last visited dec. 27, 2013). 17 ezra klein, the most important issue of this election: obamacare, wash. post: wonkblog (oct. 26, 2012, 11:13 am), http://www.washingtonpost.com/blogs/wonkblog/wp/2012/10/26/themost-important-issue-of-this-election-health-reform/ ("a vote for obama is a vote for the law to take effect and for 30 million americans to get health insurance they won't get otherwise. a vote for romney is a vote for the law-and its spending and its taxes-to be repealed. there are few elections in which the stakes are so clear."); sara r. collins et al, health care in the 2012 presidential election, commonwealth fund 9 (2012), http://www.commonwealthfund.org/~/media/files/publications/ fund%20report/2012/oct/1636_collins-hlt-care_2012-presidentialelec tionfinalcpirevised_10_02_2012.pdf ("with each candidate offering fundamentally different visions for the nation's health care system, this fall's presidential election provides a stark choice for u.s. voters."). 18 the insurance exchange legislation is found at subtitle d, part ii, § 1311 of the affordable care act. the title to part ii of subtitle d acknowledges the accountability of insurance cost savings "consumer choices and insurance competition through health benefit exchanges." 19 see generally joel m. hamme et al., health insurance exchanges under the affordable care act: a primer, 6 j. health & life scl. l., june 2013, at 35. 230 vol. 11:1 accountability partners insurance, 20 the majority of people overall will continue to get coverage from their employers. 21 two kinds of insurance exchanges are authorized under the affordable care act: (i) exchanges for individuals and (ii) small business health options program ("shop") exchanges for small business owners. 22 states have authority to decide whether to operate a single exchange to cover both types of services, or to operate interstate exchanges, or to operate exchanges in coordination with the federal government. 23 if a state elects not to establish an exchange or is unable to have an operational exchange by january 1, 2014, the federal government will operate an exchange for that state. all plans featured on the exchange must cover an 'essential' minimum benefits package that must include ten categories of benefits specified in the affordable care act. 2 4 "in a sense, the exchanges are designed to function as a marketplace for health insurance where individuals and small businesses can comparison shop and have ready access to pricing and coverage information."25 similarly divisive was the requirement that large employers offer insurance to their employees or pay a 20 cbo's analysis of the major health care legislation enacted in march 2010 before the h. subcomm. on health, 112th cong. 17 (2011) (statement of douglas w. elmendorf, director), available at www.cbo.gov/sites/default/files/cbofiles/ftpdocs/121xx/docl2119/03-30healthcarelegislation.pdf. 21 alberto r. gonzales & donald b. stuart, what implications will the supreme court's taxing power decision have on the goals of the affordable care act and healthcares 6 j. health & life sci. l. (special issue) 189 (2013) ("for many americans, the mandate likely will have little impact, as most people will have health insurance from their employer or be covered under a government or public program. ultimately, about 1 in 10 americans subject to the mandate will need to decide whether to obtain health insurance coverage or pay the penalty."). 22 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 1311(b), 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 18031(b) (2013)). 23 id. § 1311 (codified as amended at 42 u.s.c. § 18031 (2013)). 24 id. § 1302. 25 hamme, supra note 19, at 35. 2312014 indiana health law review penalty, known as the so-called "employer mandate."26 because health insurance coverage is provided by employers for most individuals, and because larger employers are able to negotiate better insurance prices and spread risks more broadly than individuals, the employer mandate was developed as an accountability tool to discourage employers from sending their employees into the newly-formed health insurance exchanges. employers with more than fifty employees will pay a penalty if an employee receives a federal subsidy to purchase insurance through a health insurance exchange. 27 opponents of the employer mandate have suggested that such a requirement will have substantial effects upon employment.28 after ongoing debate about the employer mandate, on july 1, 2013, the obama administration announced that it is delaying a major provision in the healthcare overhaul, putting off until 2015 a requirement that many employers offer health insurance.29 26 patient protection and affordable care act of 2010 §§ 1511-15 (codified as amended at 29 u.s.c. § 218a-b (2013), 26 u.s.c. §§ 125, 4980h, 6056, 6724 (2013)). 27 patient protection and affordable care act of 2010 § 1513 (codified as amended at 26 u.s.c. § 4980h (2013)). 28 see, e.g., nadia masri & sharon f. fountain, health care reform: what the employer mandate means, 31 tax mgmt. wkly. rep. 897 (2012); james a.j. revels, what effect will health reform law have on businesses and the us. economy, physicians news dig. (aug. 21, 2012, 8:38 am), http://www.physiciansnews.com/2012/08/21/ what-effect-will-health-reform-law-have-on-businesses-and-the-u-seconomy/; mark trumbull, health-care reform lawhow supreme court ruling affects families, christian scl. monitor (june 27, 2012), http://www.csmonitor.com/usa/dc-decoder/2012/0627/health-carereform-law-howsupremecourt-ruling-affects-families (last visited dec. 27, 2013). 29 internal revenue serv., dep't of the treasury, notice 2013-45, transition relief for 2014 under §§ 6055 (§ 6055 information reporting), 6056 (§ 6056 information reporting) and 4980h (employer shared responsibility provisions) (2013); see also, e.g., janemarie mulvey et al., r43150, delay in implementation of potential employer penalties under aca, cong. research serv. (july 22, 2013), http://www.fas.org/sgp/crs/misc/r43150.pdf, avik roy, white house to delay obamacare's employer mandate until 2015, far-reaching 232 vol. 11: 1 accountability partners amidst the headlines and debates about the individual mandate, insurance exchanges, the employer mandate and other publicized aspects of healthcare reform such as medicaid expansion,30 a significant element of the reform legislation involves less-discussed and less publicly disputed (but perhaps no less contentious) provisions. many of the provisions in the affordable care act receiving less public scrutiny focused on the systemic goal of providing better healthcare more efficiently, often referred to generally as "accountable care." 31 conceptually, there is generally less debate about this goal because there is more agreement about the goal of improving healthcare and reducing overall costs, which is the commonly understood goal of accountable care. while party lines are drawn primarily upon the more newsworthy elements of the affordable care act, the daily issues facing healthcare providers and patients directly involve many of these lesser-known, and sometimes lesser understood provisions. 32 many of these less-publicized implications for the private health insurance market, forbes (july 2, 2013, 6:21 pm), http://www.forbes.com/sites/theapothecary/2013/07/02/ white-house-to-delay-obamacares-employer-mandate-until-2015-farreaching-implications-for-the-private-health-insurance-market/. but even the delay of the effective date of the provision has been subject to debate. see fred lucas, congress debates if obama could unilaterally delay employer mandate, cnsnews.com (july 24, 2013, 9:09 am), http://www.cnsnews.com/news/article/congress-debates-if-obama-couldunilaterally-delay-employer-mandate#sthash. qro5l8jb.dpuf. 30 where the states stand on medicaid expansion, advisory board company (nov. 6, 2013, 5:02), http://www.advisory.com/dailybriefing/resources/primers/medicaidmap. 31 see, e.g., mark shields, from clinical integration to accountable care, 20 annals health l. 151 (2011); elliott s. fisher et al., fostering accountable health care, 28 health aff. 169, 219 (2009). 32 some of the less-publicized (and generally less controversial) examples in the affordable care act beyond the individual mandate and insurance coverage provisions include, for example, § 1003 (authorizing the secretary of the department of health and human services to review insurance premiums for unreasonable increases); § 2601 (caring for persons eligible for "dual eligibles' who are able to receive both medicare and medicaid); § 2702 (prohibiting payments for inappropriate diagnoses and treatment); §§ 2704-2706 (projects to test bundled payments, global payment systems, and pediatric accountable care 2014 233 indiana health law review topics surround the notion of accountability. often, these "accountability" provisions engender wider support from a spectrum of political parties. nearly everyone agrees that the healthcare system needs to be "fixed," but they disagree on the mechanism or method to "fix" it. the affordable care act offered several controversial proposals to revise the system, but also contained within the affordable care act are a large number of other provisions that promote greater accountability for all participants within the system. in its common meaning, accountability is an optional activity desired by the one seeking to be held responsible. in other words, the person being held accountable has made a choice to participate. however, under the affordable care act, some accountability is optional, but much of the accountability is in the form of legislated accountability. a form of accountability will occur, or the refusing parties will face a penalty. the parties enter into the accountability partnerships willingly at times and, sometimes, unwillingly. either way, legislated accountability under the reform regime will drive care in the twenty-first century in the united states. this article discusses how the affordable care act promotes, in some respects, requires physicians, hospitals, organizations); § 3001 (value-based purchasing of services from hospitals that meet performance standards); § 3006 (authorizing valuebased payments to skilled nursing facilities, home health agencies, and ambulatory surgical centers); § 3007 (payments adjusted based on cost and quality of care); § 3008 (reducing payments for hospital-acquired medical conditions); § 3022 (shared savings for accountable care organizations that meet quality and cost benchmarks); § 3023 (pilot program for bundled payments); § 3024 (testing payment incentives and service delivery models for primary care); § 3025 (reducing payments for hospital readmissions of certain conditions); § 3140 (authorizing demonstration projects of hospice program models); § 3403 (forming a medicare payment advisory board to "reduce the per capita rate of growth in medicare spending"); §§ 5001-5701 (incentives offered to students who enter primary care, nursing, geriatrics, public health, and allied health professions); § 6001 (tightening limitations on physician self-referrals); § 6301 (creating an independent patient-centered outcomes research institute to study the effectiveness of medical care); § 10606 (increasing penalties for health care fraud). vol. 11-1234 accountability partners ancillary providers, patients, and managed care providers to become accountability partners, often with each other, sometimes with their communities, the government, and their patients. depending on the context, the accountability partners change. however, in the grand scheme of healthcare, accountability is expected and is the method for pursuing the intention of the affordable care act. 3 3 attempts have been taken by other authors in the united states and internationally to discuss accountability prior to the affordable care act in the context of healthcare. 34 this article cannot, and is not intended to be, a comprehensive description of every way in which various parties are "accountability partners" under the affordable care act. rather, the goal of this article is to provide an overview of the manner in which legislated accountability (particularly the less-publicized provisions of the affordable care act) will be the method by which the united states healthcare system collectively will pursue the triple aims that donald berwick notably identified during his stint as chief of the center for medicare and medicaid services: 1. improving healthcare for individuals; 2. improving healthcare for populations; and 3. reducing per-capita cost of healthcare.35 33 see daniel r. levinson, a new era of medicare oversight, 15 j. health care l. & pol'y, 249, 262 (2012) ("as medicare adjusts to the new landscape, it will be critical for program officials and providers to place a sharp focus on ensuring accountability and transparency in the design and operation of these new programs."). 34 see, e.g., patrick j. monahan, chaoulli v. quebec and the future of canadian health care: patient accountability as the "sixth principle" of the canada health act, c.d. howe inst. (nov. 29, 2006), http://www.cdhowe.org/pdf/benefactorslecture_2006.pdf, k j woods, a critical appraisal of accountability structures in integrated health care systems, scottish health servs. pol'y f. (sept. 2002); ezekial j. emmanuel & linda l. emmanuel, what is accountability in health care., annals internal med., jan. 15, 1996, at 229. 35 see, e.g., donald m. berwick et al., the triple aim: care, health, and cost, 27 health aff., may 2008, at 759, available at http://content.healthaffairs.org/content/27/3/759.full.pdf. 2014 235 indiana health law review the triple aims have been identified as the systemic goal of healthcare in the united states. this article considers how the method of bringing about systemic changes to the entire healthcare delivery system will be accomplished through various constituencies working together as "accountability partners." there will be familiar accountability partners under the affordable care act, along with some new partners who have not worked together often previously. and these accountability partners, working together through legislatively-mandated relationships, will determine the ultimate success or failure of healthcare reform in the twenty-first century. part ii will review how the affordable care act requires accountability of providers to patients and of patients for their own care. part iii will discuss how the affordable care act promotes community accountability. part iv will discuss financial accountability of providers to the government and third party payors. part v will discuss accountability of providers among each other. ii. patient accountability the public, as well as most patients, are familiar with the notion that a physician's first obligation is to "do no harm."3 6 this basic premise suggests that a healthcare provider must use advanced education, knowledge and skill for the benefit of another party, the patient, without adding risk to the patient's condition. under this model historically, physicians were assumed by most patients to be delivering medically appropriate care, and patients entered into a relationship of trust and vulnerability that placed the healthcare provider in an immense position of power and 36 hippocrates, the corpus, 1-2 (conrad fischer ed., 2008); see also karen h. rothenberg & lynn w. bush, manipulating fate: medical innovations, ethical implications, theatrical illuminations, 13 hous. j. health l. & pol'y 1, 8 (2012) (quoting hippocrates, supra) ("whereas the hippocratic oath espoused the paradigm 'to do good or to do no harm' and percival's 1803 medical ethics expanded on professional virtues to gain public trust, theatre often dramatizes the potential of the disequilibrium in the power relationship between physician-scientists and patient-participants."). 236 vol. 11:1 accountability partners responsibility. 37 indeed, because the physician-patient relationship requires the patient to place confidence and trust in the physician, some courts "apply fiduciary principles to enforce duties involving disclosure and informed consent, patient confidences, and not withholding or fraudulently concealing information patients or related third parties are entitled to receive."38 even if the healthcare provider is in a special relationship to the patient, what level of accountability should the provider have for the patient's health outcome? at what cost should a provider be held accountable for the individual health outcome of individuals and populations? should a provider offer the best possible outcome to every patient, every time, regardless of cost? and from the opposing viewpoint, what role do individual patients have in terms of their own health, particularly when making lifestyle decisions involving tobacco use, alcohol use, diet and exercise? how do these viewpoints work together? patient accountability cuts several ways. first, providers are incentivized under the affordable care act to be accountable to patients for clinical outcomes and cost savings. a number of patient-centered efforts have also been initiated to give the patient a more central role in the process. however, patients are also now more accountable for their own care efforts. collectively, patient accountability is central to the outcomes sought under the affordable care act. a. shifting role of physician -pa tien t rela tionship in recent decades, culminating with the affordable care act, the paradigm for the physician-patient relationship has shifted. for example, a patient is no longer just a patient 3 see generally dayna bowen matthew, implementing american health care reform: the fiduciary imperative, 59 buff. l. rev. 715, 746 (2011) ("the resulting vulnerability the patient accepts by placing herself at the mercy of the physicians' exercise of discretion and power contrasts sharply with the superiority of medical knowledge and information the physician has."). 38 id. at 727. 2014 237 indiana health law review subject to the instructions of a physician who must be trusted and whose medical decisions are determinative of patient care. an emerging model of physician-patient interaction is affected significantly by the way healthcare is paid, an approach which "turn[s] patients into consumers by placing them, rather than physicians, insurers, or the government, in the driver's seat for making medical spending decisions."39 this gradual shift in orientationfrom physician-centered care to patient-centered care-has been well-documented. 40 the new model of patient care is to put the patient front and center. in fact, the very title of this type of care is known as "patient-centered" care. this is because "[t]he medical profession . . . is undergoing a profound transformation with the imperative to deliver more patient-centered care to individuals and populations, improve quality, and reduce unnecessary costs and waste."41 while a primary goal of patient-centered care is to improve clinical outcomes for patients, another equally important purpose of patient-centered care is to achieve greater cost savings on a macro level by developing a system 39 see generally mark a. hall, the legal and historical foundations of patients as medical consumers, 96 geo. l.j. 583, 587 (2008) ("this consumer characterization is the emerging centerpiece of health care policy. informed by their doctors or by their own research, and activated by their own financial interest, people with consumerdriven health insurance are expected to determine which items of health care are worth the cost and which are not, at each point of purchase in the health care delivery system."). 40 see, e.g., austin s. baldwin et al., preferences for a patientcentered role orientation: association with patient-informationseeking behavior and clinical markers of health, 35 annals behav. med. 80, 80-81 (2008) (studying patient preferences for patient-centered care); klea d. bertakis et al., patient-centered communication in primary care: physician and patient gender and gender concordance, 18 j. women's health 539, 539-40 (2009) (stating that the main methodologies for measuring patient-centeredness are "self-reported assessments . . . of the medical encounter and direct observation of the clinical encounter"). 41 paul v. miles et al., physician professionalism and accountability: the role of collaborative improvement networks, pediatrics, 131 am. acad. pediatrics (supplement) s204 (june 1, 2013), available athttp://pediatrics.aappublications.org/content/131/ supplement_4/s204.full.pdf. vol. 11:1238 accountability partners whereby patients are accountable for their own care and physicians are accountable to patients for the outcomes and for the costs of their care. b. accountability for rising patient care costs the dominant model for healthcare payment historically in the united states is a "fee-for-service" model, whereby physicians care for their patients, and, then, bill according to the volume of services provided. 42 bills are then payable by the patient, by a third-party commercial payor, or by a governmental program, and sometimes bills are not paid at all and are written off as charity care. 43 under this system, the more services provided by a physician, the greater the revenue (and the bigger the bill). providers are, therefore, incentivized to increase their volume of services as a way to earn greater financial rewards. this model of fee-for-service payment has been challenged as lacking accountability to patients and to the overall system. 44 the exponential growth rate in healthcare costs in the united states has reached historic proportions. 45 the rate 42 medicare payment advisory comm'n, report to the congress: promoting greater efficiency in medicare 63-70 (2007), available at http://medpac.gov/documents/jun07_entirereport.pdf. 43 see thomas l. hafemeister & joshua hinckley porter, don't let go of the rope: reducing readmissions by recognizing hospitals' 1duciary duties to their discharged patients, 62 am. u. l. rev. 513, 576 n.31 (2013) ("traditionally in a fee-for-service payment system, a perverse incentive exists for hospitals to not assist recently discharged patients, as hospitals can receive greater overall compensation if discharged patients relapse and return requiring more services."); see generally ann marie marciarillet, healing medicare hospital recidivism: causes and cures, 37 am. j. l. and med. 41, 72-73 (2011). 44 see generally glen cheng, the national residency exchange: a proposal to restore primary care in an age of microspecialization, 38 am. j.l. & med. 158, 160 (2012) ("the problems inherent in a fee-forservice reimbursement system, including the lack of quality control and the unbridled ability of providers to determine their own salary, were a significant factor in the rise of managed care organizations and the era of regulated healthcare expenditures."). 45 mark a. hal & carl e. schneider, when patients say no (to save money): an essay on the tectonics of health law, 41 conn. l. 2014 239 indiana health law review of growth is higher than both the rate of inflation and the growth rate for national income.46 between 1998 and 2009, the spending on healthcare doubled, and the numbers are so large that they are difficult to conceptualize. 4 7 although the affordable care act was designed to reduce the exponential increase in healthcare costs, calculations prior to the enactment of the affordable care act suggested that the amount of spending in 2019 is expected to double the spending level for 2008.48 one of the concerns with the rising cost of care is that cost does not equal quality. studies indicate that patients do not always get what they pay for because increasing healthcare costs "do not appear to be correlated with better quality."49 in fact, compared with other countries, the rev. 743, 747 (2009) ("medical spending has outstripped inflation for decades, and for decades, attempts to restrain those costs haveessentially-failed."); see also ctrs. for medicare and medicaid servs., dep't of health & human servs., national health expenditures aggregate, per capita amounts, percent distribution, and average annual percent growth, by source of funds: selected calendar years 1960-2009 tbl.1 (2009), available at http://www.cms.gov/nationalhealthexpenddata/downloads/tables.pdf, eric kimbuende et al., us. health care costs: background brief henry j. kaiser fam. found., available at http://www.losangelesdebtresource.com/files/2011/05/www.kaiseredu.org _health-care-costs.pdf (noting that healthcare expenditures have outpaced inflation and income growth). 46 ctrs. for medicare & medicaid servs., dep't of health & human servs., national health expenditure projections 20092019 tbl.1 (2009), available athttp://www.cms.gov/ nationalhealthexpenddatadownloads/proj2009.pdf. 4 7 id. 48 id. at tbl.2. 49 medicare payment advisory comm'n, report to the congress: improving incentives in the medicare program 49, 53 (2009), available athttp://www.medpac.gov/documents/ jun09_entirereport.pdf see generally christopher smith, between the scylla and charybdis: physicians and the clash of liability standards and cost cutting goals within accountable care organizations, 20 annals health l. 165, 167-69 (2011); david a. squires, explaining high health care spending in the united states: an international comparison of supply, utilization, prices, and quality, 10 commonwealth fund, issues in international health policy, may 2012, at 1, http://www.commonwealthfund.org/~/media/files/ 240 vol. 11:1 accountability partners united states spends more of its gdp on healthcare than many other nations, with questionable results in terms of whether better quality outcomes are achieved.so a recurring question when examining various efforts or payment models is whether higher quality of patient care can lead to both higher quality and can also be delivered at a lower cost. "whether viewed at the macroor microeconomic level, healthcare costs are high and getting higher, and the burden on individuals and employers is becoming increasingly heavy. these pressures serve as the genesis for the many of the cost containment efforts within the health care sector."51 c. models of cost containment before the affordable care act central to the debate about the merits of healthcare reform is whether a provider can lower cost and still provide the same quality healthcare, which is a fundamental premise of the affordable care act. even before the enactment of the affordable care act, healthcare providers were developing models of payment to promote high quality and more efficiently priced care. these models typically involved prepaid health plans, where the provider accepted financial risk for the medical outcomes of its enrollees. the concept of prepaid medical plans dates back as early as the nineteenth century, when similarly-situated groups of workers arranged to address the healthcare needs of their groups, such as the mining or railroad workers. 52 publications/issue%2obrief/2012/may/1 595_squires-explainingjhighhl t_carespendingintljbrief.pdf. 50 karen davis et al., mirror, mirror on the wall. how the performance of the us. health care system compares internationally, 2010 update, commonwealth fund, june 2010, at 2, http://www.commonwealthfund.org/-/media/files/publications/fund%20 report/2010/jun/1400_davismirrormirroronthe wall_2010.pdf. 51 smith, supra note 49, at 169. 52 a brief history of managed care, tufts managed care institute (1998), www.thci.org/downloads/briefhist.pdf (last visited july 18, 2013). 2014 241 indiana health law review more formal prepaid group plans emerged after world war i, followed by the formation of a recognizable health maintenance organization 53 in the 1940s, when industrialist henry j. kaiser opened his plans to the public after world war ii (better known as kaiser permanente).54 the american medical association ("ama") fought back against the emergence of hmos, rejecting anything resembling the corporate practice of medicine.5 5 as a result of the pushback against the new plans, the ama was convicted of violating the sherman antitrust act.5 6 in the 1980s hmo membership soared, when employers-the primary funding source for most private insurance in the united states-attempted to reduce the cost of their employees' healthcare.57 employers often continued to offer healthcare benefits but switched to hmos or other forms of prepaid care because they were considered more cost efficient than traditional fee-for-service care.58 the model of prepaid health plans began to change in the late 1990s and early 2000s as more americans were enrolled in preferred provider organizations ("ppos"). the medicare modernization act of 200359 and similar policy changes that facilitate consumer-directed health plans 53 an hmo is "a healthcare system that assumes or shares both the financial risks and the delivery risks associated with providing comprehensive medical services to a voluntarily enrolled population in a particular geographic area, usually in return for a fixed, prepaid fee." glossory: h, bluecross blueshield ass'n, http://www.bcbs.com/ glossary/?firstlet=h (last visited dec. 27, 2013). 54 tufts managed care institute, supra note 52. 55 id. 56 sherman antitrust act, 26 stat. 209 (1890) (codified as amended at 15 u.s.c. §§ 1-7 (2013)); am. med. ass'n. v. united states, 317 u.s. 519 (1943). 57 see martin markovich, the rise of hmos, rand corp., http://www.rand.org/content/dam/rand/pubs/rgs-dissertations/rgsd172 /rgsd172.chl.pdf. 58 tufts managed care institute, supra note 52. 59 medicare modernization act of 2003, pub. l. 108-173, 117 stat. 2066 (2003) (codified as amended at 26 u.s.c. §§ 6103, 7213 (2013), 45 u.s.c. § 231f (2013), and scattered sections of 42 u.s.c.). 242 vol. 11:1 accountability partners ("cdhp")60-including health savings accounts6 ("hsa") and health reimbursement accounts62 ("hra")-have caused employers to switch from hmos to ppos. just as employers switched from traditional indemnity plans in the 1980s and early 1990s, some scholars consider the move into cdhp as the first wave of consumerism in the twentyfirst century. 63 cdhc appears to fix the problems left from hmos: consumers under cdhcs are incentivized to be costsensitive and shop for high-value services, while not subjecting them to the financial risk of catastrophic illness. cdhcs allow consumers to be their own healthcare managers, which is designed to control costs and improve quality. out of this history of lowering costs and improving quality, the accountable care organization" (or "aco") developed, a model that is attributed to dr. elliot fisher, director of the center for health policy research at dartmouth medical school.64 the concept of an aco 60 the cdhp has a higher deductible, and the policy is based on either a hsa or a hra, in which individuals set aside pretax dollars designated to cover routine care. 61 hsas are tax-advantaged employee-owned savings accounts that may be used to pay for qualified medical expenses (hsas must be paired with a high deductible health plan). 62 health reimbursement accounts ("hras") are similar to hsas, but they are owned and funded by employers and do not need to be coupled with a high-deductible plan (but often are). 63 melinda b. buntin et al., consumer-directed health care: early evidence about effects on cost and quality, 25 health aff. w516 (2006), http://content.healthaffairs.org/content/25/6/w516.full.pdf. 64 kip sullivan, the history and definition of the 'accountable care organizations" physicians for nat'l health program cal. (oct. 2010), http://pnhpcalifornia.org/2010/10/the-history-and-definitionof-the-"accountable-care-organization"/. although the concept of accountable care had been around for quite some time, acos did not gain attention until 2006 and rapidly gained popularity with the publishing of a number of articles by dr. fisher and others. the buzz around acos reached its peak in 2009 with the term being used in all of the draft healthcare reform bills proposed by president obama. jenny gold, accountable care organizations, explained, kaiser health news & npr (jan 18, 2011, 8:21 am), http://www.kaiserhealthnews.org/stories/2011/january/13/acoaccountable-care-organization-faq.aspx. 2432014 indiana health law review developed in response to the steadily increasing healthcare costs and the desire to improve medicare and other private/public insurance programs. 65 d. accountability to patients for cost containment under affordable care act the affordable care act included a medicare shared savings program, authorizing contracts with acos.66 acos are intended to coordinate patient care and improve clinical outcomes by linking providers who are accountable to the patients (and to each other) for achieving the goal of collaborative, efficient, cost-effective care. shared savings will be available to providers if they meet certain criteria, including standards relating to quality, reporting, and governing structure. the ultimate goals of acos are to improve total cost, quality, and patient satisfaction. 67 acos are designed to keep patients healthy and out of intensive care settings, while basing reimbursements on top performance goals that drive improved outcomes and cost effectiveness.68 acos also hold providers accountable to one another for outcomes and cost containment, and this topic is explored further in part v below. 65 fisher et al., supra note 31, 219-31. 66 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 3022, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 1395jjj (2013)). 67 see jordan t. cohen, a guide to accountable care organizations, and their role in the senate's health reform bill, health reform watch (mar. 11, 2010), http://www.healthreformwatch.com/2010/03/11/a-guide-to-accountablecare-organizations-and-their-role-in-the-senates-health-reform-bill/. 68 jon leibowitz, chairman, fed. trade comm'n, remarks of ftc chairman joe leibowitz (as prepared for delivery), antitrust in healthcare conference, are titanic health care costs sinking us? what the ftc is doing to keep patients afloat, fed. trade comm'n 6-7 (may 3, 2012), www.ftc.gov/speeches/leibowitz/ 120503antitrusthealthcare.pdf 244 vol. 11:1 accountability partners e. toward patient-centered medicine and consumerdriven choices the transition from a physician-patient relationship where the physician is the center of the relationship, to a patient-centered approach where the patient is a consumer who has a number of choices and personal autonomy, has resulted in a number of other shifts. for example, "the relationship between patients and physicians was largely unmediated before the end of the twentieth century"69, but now patients have become consumers of healthcare services and health plans. 70 the doctrine of informed consent recognizes the change in patient power as well.7 1 patients have also progressed to become clients of their caregivers and not merely wards or subjects. 72 this subtle shift in the way patients are perceived offers an increase of power in the relationship because "medical care is a service, like any other, and . . . patients are consumers who can 69 see janet l. dolgin, the evolution of the "patient": shifts in attitudes about consent, genetic information, and commercialization in health care, 34 hofstra l. rev. 137, 140, 175-79 (2005). see generally mark a. hall, the legal and historical foundations of patients as medical consumers, 96 geo. l.j. 583, 587 (2008) (stating that healthcare initiatives "are meant to turn patients into consumers by placing them, rather than physicians, insurers, or the government, in the driver's seat for making medical spending decisions"). 70 michael j. ramdass et al., question of patients' versus 'clients,' 21 j. quality clinical prac. 14, 14 (2001) (using the term "client" instead of "patient"); see generally glen cheng, the national residency exchange: a proposal to restore primary care in an age of microspecialization, 38 am. j.l. & med. 158 (2012); mark a. hall, rethinking health law: the history and future of health care law: an essentialist view, 41 wake forest l. rev. 347, 359 (2006). 71 orna rabinovich-einy, see you out of court? the role ofadr in health care: escaping the shadow of malpractice law, 74 law & contemp. probs. 241, 247 n.19 (2011) ("in terms of patient rights, in the 1970s, a series of court decisions made way for a new approach enshrining patients' right to make informed medical decisions and to view and correct their medical records, and delineated the care team's corresponding duties.") 72 see, e.g., kristen madison, patients as 'regulators"?: patients' evolving influence over health care delivery, 31 j. legal med. 9, 1521 (2010); dolgin, supra note 69, at 175-79. 2014 245 indiana health law review choose who should provide medical services and even what kind of services to purchase."73 in this way, patientcentered care: suggests that patients' experiences as patients are important and should be taken into account, and that the law should recognize the vulnerability and suffering that illness can create and the dependency of the patient on others for knowledge, skill, or care. this in turn suggests that greater attention should be paid to the needs of the patient (beneficence) instead of merely the values of the patient (autonomy).74 with the increase of power, patients as consumers have expressed a desire to have more choices in terms of healthcare providers, insurance products, and election of procedures.75 and with more choices, patients become more accountable for their own care. in connection with offering patients more choices, the affordable care act emphasized the role of primary care and reduced reliance on specialty and emergency care. 76 73 marc a. rodwin, patient accountability and quality of care: lessons from medical consumerism and the patients' rights, women' health and disability rights movements, 20 am. j.l. & med. 147, 15357 (1994). 7 lois shepherd, different ways to understand patient-centered health law, 45 wake forest l. rev. 1469, 1470 (2010). 75 see generally troy j. oechsner & magda schaler-haynes, keepingit simple: health plan benefit standardization and regulatory choice under the affordable care act, 74 alb. l. rev. 241 (2011); deborah haas-wilson, arrow and the information market failure in health care: the changing content and sources of health care information, 26 j. health, pol., pol'y. & litig. 1031, 1034 (2001) ("when no information on quality is available prior to purchase, quality deteriorates to the lowest level in the market a serious market failure since mutually advantageous trades involving higher quality products do not take place."). 76 karen davis et al., how the affordable care act will strengthen the nation's primary care foundation, 26 j. gen. internal med. 1201 (2011), available at http://www.ncbi.nlm.nih.gov/pmc/ articles/pmc3181291/pdf/116062011_article_172o.pdf. 246 vol. 11:1 accountability partners the affordable care act contains several important provisions in this regard, including availability for increased payments to primary care providers, incentives to develop modes of primary care delivery with medical homes, increased funding for primary care residency programs, opportunities for primary care providers to qualify for federal loans and loan forgiveness, and expanded coverage of preventive care services.77 f patient-centered medical home model the patient-centered medical home ("medical home") is a care delivery model that has emerged as a method for addressing the various considerations discussed above.78 developed in concept by the american academy of pediatrics, the medical home is broadly defined as primary care that is "accessible, continuous, comprehensive, familycentered, coordinated, compassionate, and culturally effective."79 medical homes offer patients greater input and choice and involve patients in the decisions about their own care.80 a medical home is designed to promote the coordination of patient care by a family physician, who is responsible for managing overall patient wellness. the patient's personal physician is familiar with the care for the patient and, along with the patient's family and a team of 77 see generally cheng, supra note 70, at 158. 78 see melinda k. abrams et al., can patient-centered medical homes transform health care delivery, commonwealth fund (mar. 27, 2009), http://www.commonwealthfund.org/content/from-thepresident/2009/can-patient-centered-medical-homes-transformhealth-care-delivery.aspx; see also daniel fields et al., driving quality gains and cost savings through adoption of medical homes, 29 health aff. 819, 823-25 (2010), available at http://trinity.edu/ departments/healthcare/content/fa10%20mccaughrin%20articles/fiel ds,%20d..pdf. 79 see abrams et al., supra note 78; ad hoc task force on definition of the medical home, am. acad. of pediatrics, the medical home, 90 pediatrics 774 (1992), available at http://pediatrics.aappublications.org/content/90/5/774.full.pdf. 80 see generally lawrence g. smith & megan anderson, new directions in american health care, 39 hofstra l. rev. 23 (2010). 2472014 indiana health law review practitioners, works to coordinate access and referrals across medical specialties, hospitals, and nursing homes. the affordable care act includes grants to encourage specialists to provide support services for primary care providers operating within medical homes.8 1 the grants available under the affordable care act are designed to provide support for medical homes that deliver preventive care services, assist in managing chronic diseases, and promote the development of patient care plans in collaboration with specialists and primary care physicians.82 the primary care providers are expected to meet regularly with the care team, provide a plan of coordinated care for each patient, and provide access to the patient's records as necessary for coordinated treatment.83 g. patient-centered outcomes research institute the affordable care act established a new, nonprofit corporation, known as the patient-centered outcomes research institute (the "institute"), to conduct comparative effectiveness research on medical interventions. 84 the purpose of the institute is to assist patients to make informed healthcare decisions in collaboration with clinicians, purchasers, and policy-makers. the institute was established to further the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, 81 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 3502(a), 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 256a-1 (2013)); see generally stephen zuckerman et al., incremental cost estimates for the patient-centered medical home, 1325 commonwealth fund 7-10 (2009), http://www.commonwealthfund.org/-/media/files/publications/fund%20 report/2009/oct/1325_zuckermanincrementalcost_1019.pdf. 82 patient protection and affordable care act of 2010 § 3502(c) (codified as amended at 42 u.s.c. § 256a-1 (2013)). 83 id. § 3502(d)(1)-(3) (codified as amended at 42 u.s.c. § 256a-1 (2013)). 84 id. § 6301 (codified as amended at 42 u.s.c. § 1420e (2013)). 248 vol. 11:1 accountability partners and managed through research that considers variations in patient subpopulations.8 5 congress intended for the comparative effectiveness research initiative to develop hard information about the comparative effectiveness of different medical products and services. this initiative is one of a long line of federal initiatives to address the rising costs of healthcare, as well as obtain better value for healthcare expenditures. the key question is whether the governance and design features of the institute that ppaca created to oversee the initiative will enable it to succeed where other federal efforts have faltered.86 this research is designed for patient-centered outcomes and helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options.8 7 the structure of the institute is unique as a private, non-profit entity governed by a board of directors appointed by the comptroller general. the statute specifically provides that the institute is "neither an agency nor establishment of the united states government" and is organized under the district of columbia nonprofit corporation act.8 8 h promoting accountability in personal healthcare decisions notwithstanding any of the other changes to the nation's healthcare system under the affordable care act, 85 id. § 6301(d) (codified as amended at 42 u.s.c. § 1420e (2013)). 86 eleanor d. kinney, comparative effectiveness research under the patient protection and affordable care act: can new bottles accommodate old wine, 37 am. j.l. & med. 522, 524 (2011). 87 see patient-centered outcomes research, patient-centered outcomes res. inst., http://www.pcori.org/research-we-support/pcor/ (last updated nov. 7, 2013). s8 id. 2014 249 indiana health law review individual responsibility remains a key to success. an individual's willingness and ability to follow through on annual physicals, participate in preventative wellness activities including appropriate screenings, and following physician-recommended treatments are essential to reduce healthcare costs and improve the nation's overall health.8 9 consider this in light of the fact that 75% of all healthcare costs can be attributed to chronic, preventable conditions and diseases that are significantly affected by lifestyle choices such as tobacco use, alcohol abuse, poor eating habits, and physical inactivity.90 in the context of determining how to hold a patient accountable for care, many other considerations must be confronted and addressed. for example, are all patients equally accountable, or are some patients held to a different standard because of their respective personal, social, economic, or other factors? what about patients. who genuinely cannot understand the healthcare instructions of their providers?91 also, how does the system address those populations that historically have experienced higher rates of healthcare problems than others? for example, studies show that "racial and ethnic minorities tend to experience disproportionately high rates of mortality, chronic and debilitating illnesses, and infectious diseases, and they are less likely to receive certain kinds of diagnostic testing, medical procedures, and medication than non-minorities."92 and, "[t]he strange 89 see generally smith & anderson, supra note 80, at 23. 90 dep't health & human servs., prevention makes common "cents" 1 (2003), http://aspe.hhs.gov/health/prevention/prevention.pdf. 91 brietta clark, using law to fight a silent epidemic: the role of health literacy in health care access, quality, & cost, 20 annals health l. 253, 306 (2011) ("while it is certainly unfair to punish a physician for a bad result brought about by a patient's disregard of the physician's instructions, it seems equally troubling to hold patients accountable for information that is often not communicated in a clear or understandable way. to what extent can or should health literacy be relevant in helping courts make this distinction?"). 92 inst. med., unequal treatment: confronting racial and ethnic disparities in health care 2-3 (brian d. smedley et al., eds. 2003), available at http://books.nap.edu/openbook.php?recordid=10260; see also clark, supra note 91, at 317. 250 vol. 11:1 accountability partners history of race and class intersecting in u.s. medicine dates back to the antebellum period with medical experiments on enslaved women,"93 as well as "medical experimentation on vulnerable and often uninformed patients, including illiterate men, children, and prisoners."94 preventative care is a means by which patients are responsible for proactively addressing potential health concerns before they are able to become major issues. given the various considerations with respect to accountability of individual health decisions, the affordable care act provides generally for the creation of a national prevention, health promotion, and public health council (the "council") to coordinate federal agencies and initiatives for preventative wellness and public health.95 the council is headed by the surgeon general and is responsible for submitting an annual report to the president and to congress containing "a list of national priorities on health promotion and disease prevention to address lifestyle behavior modification (smoking cessation, proper nutrition, appropriate exercise, mental health, behavioral health, substance use disorder, and domestic violence screenings) and the prevention measures for the 5 leading disease killers in the united states."96 the affordable care act encourages preventative wellness by mandating that insurance companies offer a free annual wellness visit and complete coverage, without coinsurance, of services recommended in an insured's "personalized prevention plan" created by his or her 93 michele goodwin & l. song richardson, patient negligence, 72 l. & contemp. probs. 223, 230 (2009). 94 id. 95 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 4001, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 300u-10 (2013)). 96 id.; see generally nat'l prevention, health promotion and pub. health council, national prevention strategy: america's plan for better health and wellness (2011), available at http://www.surgeongeneral.gov/initiatives/prevention/strategy/report.pd f. 2014 251 indiana health law review primary care provider. 97 in addition, many preventive services now are required to waive any coinsurance payments that were previously required.98 for example, the affordable care act requires health insurers to cover 100% of the costs of immunizations, pediatric preventive care services, and grade a or b preventive services recommended by the united states preventive services task force without imposing any cost-sharing obligations on their insured.99 the goal of patient accountability is twofold: holding providers accountable for the health outcomes (and costs) of patients and holding patients accountable for their own care. 100 as the perception of the physician-patient relationship shifts, and as patients become more involved in their own health through preventative care and lifestyle choices, providers will also be expected to be accountable to populations of patients for health outcomes. together, this mutual accountability is expected to create a systemic change. iii. community accountability the affordable care act is designed to promote community accountability. indeed, several methods for. impacting care delivery in communities are part of the affordable care act. for example, community health centers are being funded to offer community infrastructure with the goal of addressing local healthcare needs, particularly for the poor and underserved. programs for reducing hospital readmissions and assisting in transitioning patients from an acute care provider to a postacute care provider are expected to aid in a patient's transition from hospital to community. also, exempt 97 patient protection and affordable care act of 2010 § 4103(a) (codified as amended at 42 u.s.c. § 1395x (2013)). 98 id. § 10406 (codified as amended at 42 u.s.c. § 1395](2013)). 99 id. 100 see generally, julie a. muroff, policing willpower: obesity as a test case for state empowerment of integrated health care, 11 hous. j. health l. & pol'y 47 (2011). 252 vol. 11: 1 accountability partners hospitals are now held accountable to monitor local health needs and report their activities to address these needs, or face financial penalties. at the heart of the notion of community accountability are more fundamental considerations: how can individuals and organizations be held accountable to their communities? does the standard of accountability include the entire community, or should access to care be available only to those who can afford it? what burden should insurance companies, healthcare providers, and employers carry with regard to the community's health? what about caring for underserved populations? and perhaps most controversially, what role does the government have in filling in the natural gaps that have arisen as a result of the way healthcare has been delivered, financed and utilized over recent decades in the united states? some would argue that the role of serving the needs of healthcare in communities should be upon a variety of sources rather than the federal government, including for example, individuals, non-profit organizations, hospitals, and emergency rooms.101 others would prefer that the federal government take a more aggressive role in regulating these areas.102 regardless of ideology, however, 101 see, e.g, paul ryan, costs, ethics & the law: essay: health care reform: the way forward, 25 notre dame j. l. ethics & pub. pol'y 337, 340 (2011) (discussing the government's growing role in health care and arguing against the affordable care act); elizabeth weeks leonard, new directions in american health care: innovations from home and abroad, article: rhetorical federalism: the value of state-based dissent to federal health reform, 39 hofstra l. rev. 111 (2010) (arguing for the repeal of the affordable care act); michael d. tanner, commentary: universal health care not best option, cato inst. (feb. 23, 2009), http://www.cato.org/publications/commentary/ universal-health-care-not-best-option (reviewing the high cost of universal health care). 102 see, e.g., len m. nichols, making health markets work better through targeted doses of competition, regulation, and collaboration, 5 st. louis u. j. health l. & pol'y 7 (2011) (arguing the benefits of "structured competition" and collaboration in health care reform); julie e. kass & john s. linehan, note, fostering healthcare reform through a bifurcated model of fraud and abuse regulation, 5 j. 2014 253 indiana health law review the role of the community in the provision, delivery and receipt of care is at the heart of the solution on both ends of the spectrum because most experts agree that home-based and community-based care can lead to better health outcomes. 103 the affordable care act is designed to generate such accountability, with the hope that a dramatic shift in the way care is delivered will occur, that the quality of care improves and that the overall cost of care will decrease. 104 a. comm unity health centers the affordable care act identified federally-qualified health centers, also known as "community health centers" as a primary way to impact local communities. 05 although community health centers ("chc") have been health & life sci. l. 75 (2012) (arguing for the government's increased regulatory role in limiting fraud and abuse for health care costs). 103 see, e.g., home the best place for health care, a positioning statement from the joint commission on the state of the home care industry, joint comm'n (oct. 18, 2011), http://www.jointcommission.org/assets/1/18/homecare-position-paper 4_5_11.pdf ("just about everyone agrees: the home is the best setting for providing health care to increasing numbers of patients"); best care at lower cost, the path to continuously learning health care in america, recommendations, inst. med. (sept. 2012), http://www.iom.edul-/media/files/report%20files/2012/best-care/ best%20care%20at%2olower%2ocostrecs.pdf (including a recommendation about the importance of community accountability). 104 aligning forces for quality, improving health & health care in communities across america, robert wood johnson found. (may 2011), http://forces4quality.org/sites/default/files/ af4qbrochurem4webmay2011.pdf, pamela mitchell et al., core principles & values of effective team -based health care, inst. med. nat'l acads. (oct. 2012), https://www.nationalahec.org/pdfs/vsrtteam-based-care-principles-values.pdf. 105 public health service act, pub. l. no. 78-410, § 330, 58 stat. 682 (1944) (codified as amended at 42 u.s.c. § 254b (2013)), amended by patient protection and affordable care act of 2010, pub. l. no. 111148, § 10406, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 254b-2 (2013)), amended by healthcare and education reconciliation act, pub. l. 111-152, 124 stat. 1029-84 (2010). vol. 11:1254 accountability partners part of community care delivery since 1965,106 the affordable care act made a deliberate economic investment in the growth and expansion of these facilities.10 7 as part of this effort, the affordable care act established funding to provide $11 billion over a five-year period for the operation, expansion, and construction of community health centers nationwide. 108 the purpose of the funding is to prepare community health centers for what is expected to be an increase in patients who are seeking care with their new insurance coverage. 109 106 kathleen sebelius, op-ed, aca gets care to those in most need, albuquerque j. (sept. 19, 2012), http://www.hhs.gov/secretary/about/opeds/acacaretothose.html ("first established in 1965, today there are more than 8,500 community health center sites across the country. . . ."); roger wilson, community health centers: optometric care within the public health community, old post pub. (2009), available at http://webpages.charter.net/ oldpostpublishing/oldpostpublishing/section%203,%2ogovernmental%2 orole%20in%2ohealth%2ocare/sect%203,%20community%2ohealth% 20centers%20by%2owilson.pdf (describing history and impact of community health centers); sara rosenbaum et al., community health centers in an era of health system reform and economic downturn: prospects and challenges, henry j. kaiser fam. found. 2 (mar. 2009), http://www.kff.org/uninsured/upload/7876.pdf ("in 2007, more than 1,200 health center grantees working in nearly 7,200 delivery sites throughout the nation furnished care to more than 16 million patients."). 107 carolyn mcclanahan, community health centers -providing a base of care, forbes (july 16, 2012, 10:08 am), http://www.forbes.com/sites/carolynmcclanahan/2012/07/16/communityhealth-centers-providing-a-base-of-care (describing community health centers as "hope for the newly insured"). 108 health res. and servs. admin., dep't health and human servs., the affordable care act and health centers, http://bphc.hrsa.gov/about/healthcenterfactsheet.pdf; health reform faqs for health centers, nat'l ass'n cmty. of health ctrs., http://www.nache.com/client/health%20reform%20faqs%20final%20for%20web.pdf. 109 expanding health centers under health reform: doubling patient capacity and bringing down costs, nat'l ass'n cmty. health ctrs. (june 2010), http://www.nachc.com/client/ hcrnewpatientsfinal.pdf [hereinafter nat'l ass'n cmty. health ctrs., expanding health centers]; leighton ku et al., policy brief no. 19: using primary care to bend the curve: the effect of national 2014 255 indiana health law review funding of community health centers is not solely a product of the affordable care act or of democratic politics. indeed, president george w. bush doubled financing for these organizations during his presidency. 110 the increased focus on, and patient visits to community health centers is undisputed and dramatic.11 ' the obama administration also has targeted community health centers as a way to emphasize primary and preventive services in a model with unique characteristics.112 for example, these organizations serve populations and communities with primary healthcare services, offering sliding fee scales based on patients' ability to pay.113 the target population for community health centers is those individuals located in rural areas, as well as the poor and underserved populations.114 sometimes, logistical issues such as cultural difference or language barriers can limit the overall health reform on health center expansions, geiger gibson / rchn cmty. health found. res. collaborative (june 30, 2010). 110 kevin sack, community health clinics increased during bush years, n.y. times (dec. 26, 2008), http://www.nytimes.com/2008/12/26/ world/americas/26iht-bush.1.18936658.html?_r=0 ("as governor of texas, bush came to admire the missionary zeal and cost-efficiency of the not-for-profit community health centers, which qualify for federal operating grants by being located in designated underserved areas and treating patients regardless of their ability to pay. he pledged support for the program while campaigning for president in 2000 on a platform of 'compassionate conservatism."'). ni irwin redlener & roy grant, america's safety net and health care reform-what lies ahead? 361 new. england j. med. 2201, 2203 (2009) (stating that during the time period between "june 2008 and june 2009, visits to community health centers increased by 14%, and visits by uninsured patients by 21%"). 112 the obama administration and community health centers, whitehouse.gov, http://www.whitehouse.gov/sites/default/files/05-0112community-healthcenter-report.pdf. 113 sara rosenbaum et al., community health centers in an era of health system reform and economic downturn: prospects and challenges, henry j. kaiser fam. found. 2 (mar. 1, 2009), http://www.kff.org/uninsuredl/uploadl/7876.pdf. 114 id.; see generally nachc principles for national health reform, nat'l ass'n cmty. health ctrs., http://www.nachc.com/client/ nachc%20principles%20for%2onational%2ohealth%2oreform.pdf. 256 vol. 11:1 accountability partners effectiveness of care. 1 15 however, the goal of a community health center is to provide a continuum of care approach that includes physicians, nurse practitioners, physician assistants, nurses, dental providers, midwives, behavioral healthcare providers, social workers, health educators, and many others.1 16 one of the expected shifts in the way care is delivered is a decrease in the number of charity care patients at hospitals and emergency rooms and an increase in the number of previously uninsured who will be able to access medical care through community health centers, which will now be able to get reimbursed for their expenditures rather than exist solely on meager fundraising efforts and small government grants.117 under the affordable care act, the estimated capacity in community health centers is expected to "increase considerably, helping to meet the new 115 see generally efrat shadmi, quality of hospital to community care transitions: the experience of minority patients, 25 int'l j. quality health care 255 (2013), http://intqhc.oxfordjournals.org/ content/early/2013/04/08/intqhc. mzt03 1.abstract (last visited dec. 28, 2013); paul m. schyve, language differences as a barrier to quality and safety in health care: the joint commission perspective, 22 j. gen. internal med. 360, 360-61 (2007), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2078554/pdf/11606_2007 article_365.pdf. 116 see, e.g., kathy poppitt & sheryl tatar dacso, federally quahifed health centers: a healthcare delivery model for a newly reformed health system, 23 health law. 1, 3 (2010). 117 rick cohen, community health centers respond to impending aca changes, nonprofit q. (apr. 8, 2013, 2:25 pm), http://www.nonprofitquarterly.org/policysocial-context/22098community-health-centers-respond-to-impending-aca-changes.html; andrea kovach & rachel gielau, the great medicaid expansion of2014 what it is and how to make it succeed, 45 clearinghouse rev. 388, 395 (2012) ("community health care providers will be vital to effective outreach because, even when adults are uninsured, they are likely to seek care at a community health center, hospital emergency room, or drug treatment center. other avenues for outreach are unemployment offices, job-training centers or career fairs, community colleges, food stamp offices, the social security administration's supplemental security income offices, charity care organizations such as food banks and domestic violence shelters, and local businesses."). 2014 257 indiana health law review demands for primary health care that are expected once more people have health insurance coverage." 118 a predictable response to the increased funding of community health centers follows: "this sounds great! but what is it going to cost? and who is going to pay for it?" according to the national association of community health centers, "research studies demonstrate that health centers yield substantial cost savings to the health care system by reducing emergency department visits, hospitalizations, and other avoidable, costly care."119 the study relied upon by the national association of community health centers suggests that the increased funding of community health centers will actually result in long-term savings to the federal healthcare program and offer ways to address the increased demand for healthcare under the affordable care act: our findings indicate that the expansion of community health centers will play an essential role in addressing two of the longterm challenges of health reform: curbing the growth of overall health care expenditures and bolstering the capacity of the primary care system to meet the needs of the millions of newly insured americans. 120 indeed, this study further concludes that the role of community health centers is so crucial to effectively managing healthcare costs for populations, that "the expansion of health centers can reduce both federal and state medicaid expenditures." 12 1 the expansion of community health centers will also result in the creation 118 ku et al., supra note 109, at 6. 119 see nat'l ass'n cmty. health ctrs., expanding health centers, supra note 109; see generally ku et al., supra note 109. 120 ku et al., supra note 109, at 9. 121 id. 258 vol. 11:1 accountability partners of jobs for providers and other workforce at these facilities.122 while opposition remains to the increased emphasis in community health centers, 123 the affordable care act has targeted these organizations as a fundamental way that care will be delivered in the twenty-first century. by focusing on local entities that provide care to the poor and underserved, the affordable care act is intentionally requiring community accountability. b. transitioning patients from hospitals back to the community another problem facing communities is the difficult transition for inpatients from hospital care to another stage of post-acute care. when a patient is transferred from one healthcare provider to another, the likelihood for readmission or need for additional inpatient care remains a costly scenario for many patients and providers.124 studies suggest that between 18-20% of medicare patients who are admitted to acute care hospitals are later readmitted within thirty days of discharge, at an estimated annual cost of as 122 see community health centers lead the primary care revolution, nat'l ass'n cmty. health ctrs. (aug. 2010), http://www.nachc.com/client/documents/primarycarerevolutionfina 1_8_16.pdf. 123 see generally dan hawkins & dashawn groves, the future role of community health centers in a changing health care landscape, 34 j. ambulatory care manage 91 (2011) (describing "often-powerful political opposition"); bonnie lefkowitz, community health centers: a movement and the people who made it happen 12 (2007). 124 marciarillet, supra note 43, at 44 ("it turns out that medicare hospitalization recidivism is not one problem but a constellation of interlocking problems: primarily those of the failure to provide ongoing care for the chronically ill, the problem of medically inappropriate primary hospitalizations and rehospitalizations, and the failure to effectively plan and deliver the services necessary for successful community re-entry upon acute care hospital discharge. combine these with our systemic problems of failure to deliver primary care and the standardless provision of health care and the recipe is complete."). 2592014 indiana health law review much as $26 billion.125 worse, within ninety days of discharge, the readmission percentage rises to 34%.126 this means that statistically, one out of every three patients who are transitioned out of a hospital will be back again within three months, and this is a considerable concern and financial burden for communities. accountability for transitioning care in a way that reduces readmissions is a responsibility facing a number of participants in the process. 127 the affordable care act attempts to address the frequency of readmission in several ways. for example, the affordable care act created a new center for medicare and medicaid innovation that will be tasked with identifying local models that address a defined population with poor clinical outcomes or avoidable expenditures, and then expanding solutions nationwide.128 the affordable care act also funded research for, among other things, practical methods for reducing preventable hospital admissions and readmissions.12 9 the affordable care act also established a national pilot program on bundling beginning in 2013, which establishes a national, voluntary five-year pilot program on bundling payments to providers around ten conditions. 130 125 see stephen f. jencks et al., rehospitalizations among patients in the medicare fee-for-service program, 360 new eng. j. med. 1418, 1421 (2009), available athttp://www.nejm.org/doi/pdf/10.1056/ nejmsa08o3563; see also laura landro, keeping patients from landing back in hospital, wall st. j. (dec. 12, 2007, 12:01 am), http://online.wsj.com/article/sb119741713239122065.html; see also marciarillet, supra note 43, at 44-45, 80, n.17. 126 jencks et al., supra note 125, at 1421. 127 douglas mccarthy et al., recasting readmissions by placing the hospital role in community context, 309 jama 351 (2013). 128 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 3021, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 300jj-51 (2013)). 129 id. § 3501 (codified as amended at 42 u.s.c. § 299b-33 (2013)). 130 id. § 3023 (codified as amended at 42 u.s.c. § 1395cc-4 (2013)). the secretary of the department of health and human services selects the ten conditions to be included in the pilot program based upon a combination of chronic and acute conditions, surgical, and medical conditions, and conditions where providers are able to improve quality 260 vol. 11:1 accountability partners the affordable care act established the hospital readmissions reduction program, which is designed to offer hospitals a financial disincentive for readmissions.131 beginning in 2013, hospitals that have higher than expected readmissions based on the thirty-day readmission measures for heart attack, heart failure, and pneumonia will have their medicare reimbursement decreased for all medicare discharged patients. 132 as a way to assist hospitals with high readmission rates, the affordable care act also implemented programs for patient safety organizations to assist hospitals in the reduction of these readmissions. 133 these programs are focused upon hospitals' efforts to address the care transition problem, because hospitals are able to focus on those components that they are directly responsible for, including the quality of care during the hospitalization and their role in the patient discharge process. however, there are multiple factors along the care continuum that impact readmissions, and focusing accountability on the actions of post-acute care providers, as well as the patients themselves are also important parts of the equation. hospitals are not the sole cause of readmissions because "[certain conditions at discharge are disproportionately represented in unplanned medicare rehospitalizations."13 4 while reducing costs, that are able to be bundled across a spectrum of care. 131 id. § 3025 (codified as amended at 42 u.s.c. § 1395ww (2013)). 132 see corrections to final rules relating to medicare, hospitals, and other healthcare providers, 78 fed. reg. 15,822 (mar. 13, 2013) (codified at scattered parts of 42 c.f.r.), see also readmissions reduction program, ctr. for medicare & medicaid servs. http://www.cms.gov/medicare/medicare-fee-for-service-payment/ acutelnpatientpps/readmissions-reduction-program.html (last visited dec. 28, 2013). 133 patient protection and affordable care act of 2010 § 399kk (codified as amended at 42 u.s.c. § 280j-3 (2013)). 134 marciarillet, supra note 43, at 46-47 ("the top five medical conditions generating the most readmissions concern: heart failure, pneumonia, chronic obstructive pulmonary disease, psychoses, and gastrointestinal problems."). 2014 261 indiana health law review recognizing the varying roles of hospitals, patients, and post-acute care providers in the transition process, the affordable care act also established a community-based care transitions program ("cctp)135 for improving care transitions from the hospital to other settings and reducing readmissions for high-risk medicare beneficiaries. the cctp is particularly notable in its design as a deliberate way for hospitals and community organizations to become accountable to one another. the cctp is also part of a public-private partnership, partnership for patients, 136 offering yet another program for encouraging community accountability to improve quality, reduce cost, and improve patient experience. the cctp, launched in 2011, will run for five years with up to $500 million in funding available. 137 the goals of the cctp are to improve transitions from the inpatient hospital setting to other care settings to improve quality of care, to reduce readmissions for high risk beneficiaries, and to document measurable savings to the medicare program. 138 the cctp proposes to coordinate the efforts of local, community-based organizations ("cbos") to manage medicare patients' transitions out of hospitals and into the community.13 9 collectively, these efforts attempt to provide ways in which individuals and organizations can held accountable to their communities. the affordable care act's emphasis on community accountability focuses specifically on ways that the poor and underserved are able to access care. 135 cctp was created by patient protection and affordable care act of 2010 § 3026 (codified as amended at 42 u.s.c. § 1395b-1 (2013)). 136 see partnership for patients, ctrs. for medicare & medicaid servs., http://innovation.cms.gov/initiatives/partnership-for-patients/ index.html (last visited dec. 28, 2013). 137 community-based care transitions program, ctrs. for medicare and medicaid servs., http://innovation.cms.gov/initiatives/ cctp/ (last visited dec. 28, 2013). 138 id 139 id. 262 vol. 11:1 accountability partners c. accountability of exempt hospitals to their comm unities the affordable care act also addressed a growing concern that tax-exempt hospitals are not held accountable to their communities.140 the concern derives from the perception that some non-profit hospitals operate and make decisions like any for-profit business and yet receive a significant tax break in their operations.141 for the past several years, 501(c)(3) hospitals have been at the focus of senate finance committee's charles grassley's call for accountability. 14 2 senator grassley, a republican, identified a need for exempt hospitals to show that they deserve their exemption.143 in a similar type of accountability dispute, provena covenant medical center 140 thomas lee hazen & lisa love hazen, punctilios and nonprofit corporate governance -a comprehensive look at nonprofit directors' fiduciary duties, 14 u. pa. j. bus. l. 347, 353 (2012) ("a specific example of the debate surrounding the federal tax exemption is the concern in recent years that nonprofit hospitals are really disguised for-profit enterprises with an undeserved tax advantage."); see also scott allen & marcella bombardieri, much is given by hospitals, more is asked, nonprofits reaping more in tax breaks than they report in charity work. some say that must change, bos. globe, may 31, 2009, at 1; lynnore seaton & beth c. koob, tax-exempt hospitals and community benefit, health law., june 2009, at 37, 38 (stating that there is "no clear guidance in the law as to what congress considered to be charitable, or what the motivations were for exempting charitable organizations from taxation."). 141 lynnore seaton & beth c. koob, supra note 140, at 38. 142 memorandum from the u.s. committee on finance to reporters and editors, grassley: gao finds troubling nonprofit hospitals' executive compensations (july 28, 2006), available at http://www.finance.senate.gov/newsroom/chairman/release/?id=b43c8ad 4-5201-410c-860d-b63ab8ec92d3 (last visited dec. 28, 2013); see also lisa kinney helvin, note, caring for the uninsured. are not-for-profit hospitals doing their share?, 8 yale j. health pol'y l. & ethics 421, 449 (detailing senator grassley's various inquiries into hospital exemption). 143 press release, senator chuck grassley, grassley's provisions for tax-exempt hospital accountability included in new health care law (mar. 24, 2010), available at http://www.grassley.senate.gov/news/ article.cfm?customel datapageidj 502=25912 (last visited dec. 28, 2013). 2014 263 indiana health law review lost its state property tax exemption because it did not demonstrate that it offered a substantial amount of medical services to the poor.144 nationwide, about 2900 hospitals (60% of hospitals) are non-profit, and the value of tax-exemption collectively for these hospitals is more than $12.6 billion.145 in response, communities expect accountability from their local nonprofit hospitals in the form of services in addition to traditional fee-for-service medical care. for example these services may include providing, below-cost medical services for the poor, the availability of emergency room services and other medical services, access to free clinics and preventative care, education of the public on medical matters, and involvement and financial support of local charities.146 exempt hospitals are "organized and operated exclusively for . . . charitable . . . purposes" 14 7 and receive the benefit of their exempt status in part based upon the perceived "community benefit" that they provide to their localities.148 prior to the affordable care act and beginning with the 2009 tax year, the internal revenue service ("irs") introduced a revised form 990, which sets up a 144 provena covenant med. ctr. v. dep't of revenue, 925 n.e.2d 1131, 1144 (ill. 2010). 145 nonprofit hospitals and the provision of community benefits, cong. budget office 3, 5 (2006), available at http://www.cbo.gov/sites/ default/files/cbofiles/ftpdocs/76xx/doc7695/12-06-nonprofit.pdf; see also what's new with community benefit., robert wood johnson found. (oct. 2012), http://www.rwjf.org/content/dam/farm/reports/issuebriefs/ 2012/rwjf402124. 146 jim doyle, nonprofit hospitals' huge tax breaks under increasing scrutiny, st. louis post-dispatch (oct. 23, 2011, 11:00 pm), http://www.stltoday.com/business/local/article4a0dcdl7-40b3-589fb0e7-c3dc14b62804.html. 147 exemption from tax on corporations, certain trusts, etc., 26 u.s.c. § 501(c)(3) (2013). 148 rev. rul. 69-545, 1969-2 c.b. 117, available at http://www.irs.gov/pub/irs-tege/rr69-545.pdf see generally internal revenue serv., irs exempt organizations (te/ge) hospital compliance project final report (2009), available at http://www.irs.gov/pub/irs-tege/frepthospproj.pdf. 264 vol. 11:1 accountability partners required and standardized method for all nonprofit hospitals to report financial information. 149 the affordable care act includes specific public reporting obligations for hospitals to hold them accountable to their communities and to ensure that their exempt status is deserved. 150 the affordable care act creates a new § 501(r) of the internal revenue code, 151 detailing new requirements for hospitals, which include the following: 1. conduct a "community health needs assessment" ("chna") at least once every three years and adopt a strategy to respond to the needs identified by the assessment; 2. establish written financial assistance policies addressing patient eligibility for financial assistance and emergency care; 3. limit the amount charged to patients eligible for financial assistance for emergency or medically necessary care to the amount generally billed for insured patients; and 4. refrain from pursuing "extraordinary collection actions" without first inquiring whether a patient is eligible for financial assistance. 152 irs published a proposed rule titled community health needs assessments for charitable hospitals, detailing reporting obligations for hospitals as part of the affordable care act and clarifying the consequences for failing to meet these and other requirements for charitable hospital 149 internal revenue serv., dep't treasury, omb no. 15450047, irs form 990, return of organization exempt from income tax (2012), available at http://www.irs.gov/pub/irs-pdf/f990.pdf. 150 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 9007, 124 stat. 119-1025 (2010) (codified as amended at scattered sections of 26 u.s.c.). 151 exemption from tax on corporations, certain trusts, etc., 26 u.s.c. § 501(r) (2013). 152 id.; patient protection and affordable care act of 2010 § 9007 (codified as amended at scattered sections of 26 u.s.c.). 2014 265 indiana health law review organizations.153 at the heart of these new requirements for exempt hospitals is a standard of accountability that requires hospitals to demonstrate tangible, identifiable community benefits in exchange for their tax exemption. the chna requirement holds hospitals accountable, at least once every three years, for soliciting input from community representatives. 154 once hospitals complete the chna, they must make the assessment "widely available to the public."155 hospitals must adopt an implementation strategy to meet the community health needs identified in the health needs assessment must report to the internal revenue service how the organization is addressing the needs identified. 5 6 hospitals must now adopt written financial assistance policies that establish clear criteria for how patients will receive financial assistance. the written financial assistance policy must include (i) eligibility criteria for financial assistance and whether such assistance includes free or discounted care, (ii) the basis for calculating amounts charged to patients, (iii) the method for applying for financial assistance, (iv) in the case of an organization which does not have a separate billing and collections policy, the actions the organization may take in the event of nonpayment, including collections action and reporting to credit agencies, and (v) measures to widely publicize the policy within the community to be served by the organization.157 hospitals must also refrain from engaging in extraordinary collection efforts before making reasonable efforts to determine whether the individual from whom 153 community health needs assessments for charitable hospitals, 78 fed. reg. 20,523 (proposed april 5, 2013) (to be codified at 26 c.f.r. pts. 1, 53). 154 exemption from tax on corporations, certain trusts, etc., 26 u.s.c. § 501(r)(3)(b)(i). 155 exemption from tax on corporations, certain trusts, etc., 26 u.s.c. § 501(r)(3)(b)(ii). 156 patient protection and affordable care act of 2010 § 9007(d) (codified as amended at 26 u.s.c. § 6033 (2013)). 157 patient protection and affordable care act of 2010 sec. 9007(a)(4), § 501(r)(4) (codified as amended at 26 u.s.c. § 501(r)(4) (2013)). 266 vol. 11:1 accountability partners collection is sought would be eligible for assistance under the financial assistance policy.' 58 of all the community accountability standards established by the affordable care act, the hospital requirements are perhaps the most comprehensive. a major goal of this provision is to hold hospitals accountable for addressing any disparities in healthcare that exist among populations. 59 in response to years of questioning whether hospitals deserve their tax-exempt status, the affordable care act requires tax-exempt hospitals to demonstrate on an ongoing basis that they are in fact providing community benefits. hospitals will assess what specific health needs their communities have, implement ways to meet those needs, and will then report what they are doing to the irs. any tax-exempt hospital that fails to comply with these requirements will be subject to a $ 50,000 excise tax.160 the affordable care act offers several methods for impacting care delivery in communities. community health centers address care for the poor and underserved, while other programs are designed to assist the transition from an acute care provider to a post-acute care provider. non-profit hospitals are now held accountable to monitor local health needs and report their activities to address these needs, or they will face financial penalties. the role of various healthcare providers within the community in connection with the provision, delivery and receipt of care is at the heart of the solution on both ends of the spectrum. community-based care is at the heart of community accountability, with the hope that a dramatic shift in the way care is delivered will occur, that the quality of care improves and that the overall cost of care will decrease. 158 patient protection and affordable care act of 2010 sec. 9007(a)(6), § 501(r)(6) (codified as amended at 26 u.s.c. § 501(r)(6) (2013)). 159 mary crossley, tax-exempt hospitals, community health needs and addressing disparities, 55 how. l.j. 687, 701 (2012). 160 patient protection and affordable care act of 2010 § 9007(b) (codified as amended at 26 u.s.c. § 4959 (2013)). 2014 267 indiana health law review iv. accountability to government under the affordable care act, regulators are now given broader enforcement authority to hold providers, practitioners, and patients accountable for the healthcare that is delivered and healthcare services that are sought. various mechanisms under the affordable care act focus squarely on improving quality, efficiency, transparency and integrity of the provision of healthcare in the united states.161 this increased accountability towards transparency and integrity among providers and practitioners works to ensure that, when the government is paying for a service, it can hold these constituencies responsible for the care provided and the level of transparency necessary to promote a more efficient healthcare system. because the federal government finances a considerable portion of healthcare in the united states, it is necessary for the government to 'get its money's worth' by holding participants accountable for the way monies are applied.162 yet the manner of accountability is complicated. how can the federal government provide necessary incentives to health insurance companies to ensure that they are focusing on patient needs rather than emphasizing profitability at the patients' expense? what level of accountability is necessary to ensure practitioners, patients, and providers do not abuse the reimbursement that is available from the federal government? has the affordable care act implemented mechanisms to ensure accountability is consistent and fair? 161 see, e.g., howard k. koh & kathleen g. sebelius, promoting prevention through the affordable care act, 363 new eng. j. med. 1286 (2010); robert p. kocher & eli y. adashi, hospital readmissions and the affordable care act: paying for coordinated quality care, 306 jama 1794 (2011); tom baker, health insurance, risk, and responsibility after the patient protection and affordable care act, 159 u. pa. l. rev. 1577 (2011). 162 see generally alyene senger, federal spending on health care doubles in the next decade, heritage found. (feb. 1, 2012, 3:18 pm), also available at http:/i/blog.heritage.org/2012/02/01/federal-spending-onhealth-care-doubles-in-the-next-decade/. vol. 11:1268 accountability partners although there are numerous ways in which the affordable care act generates greater accountability, the government is holding health insurers, healthcare entities, physicians, and other providers accountable to create a more transparent healthcare system. first, the affordable care act focuses on several matters that directly change the way that health insurance companies can do business. 163 these provisions aim to ensure that health insurers are first and foremost accountable to their enrollees rather than their investors. second, the affordable care act implemented general fraud and abuse standards that impact many different healthcare actors who interact with federal healthcare programs. these new laws, funding, and programs act as general mechanisms to ensure healthcare participants are being compliant with the laws and making decisions that are in the best interest of all healthcare participants. finally, the affordable care act specifically implements laws and programs in which physicians are targeted. ultimately, these laws aim to develop fewer conflicts and more transparency among physicians' decisions. a. health insurer accountability under the affordable care act, the federal government is in the process of implementing sweeping changes, which may yield a considerably higher level of transparency and integrity between the federal government and health insurance companies. 164 the need for accountability arises 163 see e.g., guaranteed availability of individual health insurance coverage to certain individuals with prior group coverage, 42 u.s.c. § 300gg-41(a)(1) (2013); group health plans and health insurance issuers relating to coverage of preventive services under the patient protection and affordable care act, 77 fed. reg. 8725 (feb. 15, 2012); patient protection and affordable care act of 2010 § 10406 (codified as amended at 42 u.s.c. § 13951(2013)); patient protection and affordable care act of 2010 § 2719 (codified as amended at 42 u.s.c. § 300gg-19 (2013)); patient protection and affordable care act of 2010 § 1331 (codified as amended at 42 u.s.c. § 18051 (2013)). 164 see e.g., jeffrey t. kul1gren et al., a census of state health care price transparency websites, 309 jama 2437 (2013); anne weiss, 2014 269 indiana health law review within insurer functions such as pricing, communication with enrollees, communication with providers, coverage issues, and a multitude of other instances. for example, health insurers, prior to the affordable care act, used various tactics to deny coverage for an episode of care. this meant that a patient who was enrolled with a specific health insurer and who required an expensive form of care (which the insurer should cover) was denied coverage for the specific episode of care. previously, the appeals process for such denials was not defined by federal law, but this has changed under the affordable care act. another example of transparency and integrity is the concept of minimum coverage for insurance policies. health insurance packages varied among insurers and products, and many times high-cost care would be covered by a basic policy but basic preventive care would not be covered. in some cases, an individual may assume that a routine checkup was covered, but the individual learned when the bill arrived that the basic preventative checkup was not covered under the policy. variations on these types of problems have created a multitude of situations in which health insurance companies needed to be more transparent and accountable. health insurance pre-affordable care act operated in ways in which it was not as necessary for the consumer to be actually involved in the financing process because employers generally shouldered this burden. 165 in fact, as of 2004, approximately 60% of the u.s. population received health insurance coverage through their employers. 166 transforming care through transparency, health aff. blog (oct. 5, 2012), http://healthaffairs.org/blog/2012/10/05/transforming-carethrough-transparency/; u.s. govt accountability off., gao-11-791, report to congressional requesters: health care price transparency: meaningful price information is difficult for consumers to obtain prior to receiving care (2011), available at http://www.gao.gov/new.items/d11791.pdf. 165 thomas bodenheimer & kevin grumbach, paying for health care, 272 jama 634, 635-36 (1994). 166 paul fronstin, uninsured unchanged in 2004, but employmentbased health coverage declined, 26 emp. benefit res. inst. notes 2 (2005). vol. 11:1270 accountability partners however, individuals seeking to purchase insurance on the open market without the benefit of employer-sponsored coverage have long faced problems.16 7 for example, insurers often used the mechanism of preexisting conditions to refuse coverage to consumers on the individual market because those conditions increase the likelihood of claims.168 this resulted in a health insurance system in which consumers relied heavily on employers because they would be covered even with preexisting conditions169, while consumers in individual markets would not. this obstacle along with price transparency helped to develop a health insurance system in which there was little accountability between the government, insurers, and consumers. to remedy the problem facing consumers seeking to purchase non-employer sponsored insurance coverage, the affordable care act implemented several strategies that help curb this lack of accountability among the government, insurers, and consumers. first, the affordable care act added several consumer protections for when consumers 167 michelle m. doty et al., failure to protect: why the individual insurance market is not a viable option for most us. families, 63 commonwealth fund 1 (2009), http://www.commonwealthfund.org/-/ media/files/publications/issue%20brief/2009/jul/failure%20to%2oprot ect/1300_doty-failure-to-protectindividualinsmarketibv2.pdf, mary mahon et al., new report: individual health insurance market failing consumers, commonwealth fund (july 21, 2009), http://www.commonwealthfund.org/-/media/files/news/news%20releas es/2009/jul/failure%20to%2oprotect%20pr%20final%2072109%20re v2.pdf. ("seventy-three percent of people who tried to buy insurance on their own in the last three years did not purchase a policy, primarily because premiums were too high. in addition, among adults with individual coverage or who tried to buy coverage in the past three years, 57 percent said it was very difficult or impossible to find coverage they could afford, 47 percent said it was very difficult or impossible to find a plan with the coverage they needed, and 36 percent were denied coverage or charged more because of a pre-existing condition, or had the condition excluded from their coverage."). 168 james p. baker, equal benefits for equal work? the law of domestic partner benefits, 14 lab. law. 23, 45 (1998). 169 guaranteed availability of individual health insurance coverage to certain individuals with prior group coverage, 42 u.s.c. § 300gg-41(a)(1) (2013). 2014 271 indiana health law review deal with the insurance industry.170 in particular, there are now prohibitions on placing lifetime limits on coverage and on rescinding coverage once the limit has been met, which avoids the problem of loss of coverage for a high-cost health issue.171 for example, a toddler in need of a heart transplant exhausted her $1 million lifetime maximum on her insurance policy after three weeks.172 as another example, a teenager diagnosed with a form of leukemia in 2007 reached his maximum limit in less than a year and was left with the option of a $600,000 deposit or $500,000 payment for a bone marrow transplant. 173 although the family raised the necessary amount of funds, the young man died before he could receive the transplant.174 this problem is not an anomaly, because according to the henry j. kaiser family foundation, 22% of employees have caps of less than $2 million. 75 next, with respect to the coverage of preventive benefits, the affordable care act operates to hold more insurers accountable for covering the basic needs of individuals.176 according to a study performed by northwestern university faculty and students in 2008, "many insurers choose not to cover preventive care and other treatments that have high 170 patient protection and affordable care act: preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections, t.d. 9491, 75 fed. reg. 37,188 (june 28, 2010) (codified at 26 c.f.r. pts. 54, 602, 29 c.f.r. pt. 2590, 45 c.f.r. pts. 144, 146, 147). 171 id. 172 tom murphy, patients struggle with health insurance caps, l.a. times (july 14, 2008), http://articles.latimes.com/2008/jul/14/ business/fi-lowcaps14. 173 health insurance caps leave patients stranded, nbcnews.com, http://www.nbenews.com/id/25644309/ns/healthhealthcare/t/health-insurance-caps-leave-patientsstranded/#. ugfbnzk2m64 (last updated july 13, 2008, 1:29:36 pm). 174 id. 175 id. 176 group health plans and health insurance issuers relating to coverage of preventive services under the patient protection and affordable care act, 77 fed. reg. 8725, 8726 (feb. 15, 2012). 272 vol. 11:1 accountability partners up-front costs."177 beginning on september 23, 2010, health insurance companies are now required to provide minimum coverage that includes preventive care.178 in addition, many preventive services now are required to waive any coinsurance payments that were previously required.179 as of 2013, the affordable care act has extended free preventive care to 71 million americans. 80 another additional consumer protection promoting accountability relates to insurance coverage appeals processes.181 in particular, group health plan and health insurance issuers are now required to implement effective appeals processes allowing the enrollee notice and the chance to review their file.182 a 2008 study by the american medical association found that between 2.65% and 6.8% of claims were denied;183 however such denials often lacked any sort of notification or appeals process, which often led to reversals.184 177 pat vaughan tremmel, study seeks win-win for insurance coverage for preventive care, nw. univ. newscenter (jan. 15, 2008), http://www.northwestern.edu/newscenter/stories/2008/01/ insuranceprev.html. 178 see key features of the affordable care act by year, u.s. dep't health & human servs., http://www.hhs.gov/healthcare/facts/timeline/ timeline-text.html (last visited jan. 13, 2014). 179 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 10406, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 13951(2013)). 180 press release, dep't health & human servs., affordable care act extended free preventive care to 71 million americans with private health insurance (mar. 18, 2013), available at http://www.hhs.gov/news/press/2013pres/03/20130318a.html (last revised aug. 5, 2013). 181 patient protection and affordable care act of 2010 § 2719 (codified as amended at 42 u.s.c. § 300gg-19 (2013)). 182 guaranteed availability of individual health insurance coverage to certain individuals with prior group coverage , 42 u.s.c. 300gg-19. 183 tv ad overstates health insurance denials, politifact.com (sept. 18, 2009, 3:57 pm), http://www.politifact.com/truth-ometer/statements/2009/sep/18/health-care-america-now/ty-adoverstates-health-insurance-denials/. 184 see generally u.s. gov't accountability off., gao-11-268, report to the secretary of health and human services and the 2014 273 indiana health law review the claim denial process was a problem because it left many individuals with little options but to pay for their care out-of-pocket. for example, a school administrator was denied coverage for her arthroscopic surgery when she underwent the surgery for bone spurs. 85 the total bill for the surgery was $21,225.186 although the patient was eventually able to settle with the insurance company for less than the total cost, claim denial processes are a substantial issue with 100 million claims being initially denied per year.187 the affordable care act implemented the minimum medical loss ratio for insurers to avoid perceived money grabs by insurance companies.188 in particular, this requires health plans to report the proportion of premiums spent on services for enrollees and providing a rebates to enrollees if the share of the premium spent on services is less than 85%. 189 the primary goal of this provision is to allow enrollees benefits, or rebates, when the services that were provided were less than 85% of the premiums paid. this requirement allows the government to provide additional accountability on health insurers to spend premiums'9 0 on services to enrollees rather than corporate or shareholder benefits. although this issue is controversial secretary of labor: private health insurance data on application and coverage denials (2011), available at http://www.gao.gov/new.items/d11268.pdf. 185 walecia konrad, fighting denied claims requires perseverance, n.y. times (feb. 5, 2010), http://www.nytimes.com/ 2010/02/06/health/06patient.html?pagewanted=all&_r=0. 186 id. 187 id. 188 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 1331, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 18051 (2013)). 189 42 u.s.c. 18051 (2013). 190 see generally obamacare in three words: saving people money, whitehouse.gov (july 18, 2013), http://www.whitehouse.gov/share/ health-care-rebate ($500,000,000 in rebates were provided back to enrollees during 2012). 274 vol. 11:1 accountability partners to some,191 the end goal is to create a more accountable and transparent health insurance system. b. fraud and abuse promoting accountability the affordable care act implemented several programs and laws in which the focus was on high-risk areas of fraud and abuse within healthcare. for fiscal year 2011, the office of inspector general was responsible for $4.1 billion in recoveries, a global number that may not seem significant but its impact on individual providers can be substantial.192 fraud and abuse has been a primary issue for the federal government over the past twenty years; 93 however the affordable care act implemented new efforts for increased enforcement and laws in which high-risk areas are further deterred from.194 with respect to the high-risk areas, the affordable care act implemented several laws in which durable medical 191 robert book, obama touts false benefits of health insurance rebates, forbes (july 18, 2013, 7:19 pm), http://www.forbes.com/sites/ theapothecary/2013/07/18/obama-touts-false-benefits-of-healthinsurance-rebates/ (explaining that the rebates are "not really savings because the mlr, perhaps unintentionally, actually encourages insures to increase premiums"). 192 dep't of health and human servs. & dep't of justice, health care fraud and abuse control program annual report for fiscal year 2011 (2012), available athttp://oig.hhs.gov/ publications/docs/hcfac/hcfacreport201l1.pdf. 19s see generally jennifer staman, cong. research serv., rs22743, health care fraud and abuse laws affecting medicare and medicaid: an overview (2010) ("a number of federal statutes aim to combat fraud and abuse in federally funded health care programs such as medicare and medicaid. using these statutes, the federal government has been able to recover billions of dollars lost due to fraudulent activities."), available at http://www.adea.org/documents/ sectionl/(1.3. 1)-anti-kickback-statute.pdf see also aaron m. altschuler et. al., health care fraud, 35 am. crim. l. rev. 841, 843 (1998); ann w. morrison, an analysis of anti-kickback and self-referral law in modern health care, 21 j. leg. med. 351, 354 (2000). 194 t.r. goldman, eliminating fraud and abuse, health aff. (july 31, 2012), http://healthaffairs.org/healthpolicybriefs/briefpdfs/ healthpolicybrief_72.pdf. 2752014 indiana health law review equipment ("dme") is curbed. 195 dme is reimbursed through medicare part b and includes such items as diabetic testing strips, canes, crutches, hospital beds, suction pumps, and many other types of equipment used to aid in an individual's care. 196 this is a high-visibility area in terms of potential fraud, as medicare spent more than $10 billion in 2009 on dme, and more than half was improperly spent.197 home healthcare is similarly ripe with opportunities for fraud and abuse. 198 other high-risk areas focused on were hospice fraud and nursing home fraud. by focusing on these high-risk areas, the affordable care act deliberately operates to hold organizations accountable for necessary, but proper, care and to further the idea of transparency in healthcare. in particular, the affordable care act is designed to inhibit providers and companies from committing fraudulent acts at the outset. one way to accomplish this goal is to require more 'face-to-face' encounters at the beginning of a patient relationship. previously, there were many ways in which fraud would occur in situations where face-to-face encounters were not a prerequisite to payment. fraud occurred when dme companies provided dme to 'patients' who had died, or when dme suppliers provided equipment that was never requested. 199 as recently as july 2013, the justice department charged a dme supplier for medicare fraud in relation to over $11 million in fraudulent billings.200 195 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 6407, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. §§ 1395f, 1395m, 1395n (2013)). 196 your medicare coverage: durable medical equipment (dme) coverage, medicare.gov, http://www.medicare.gov/coverage/durablemedical-equipment-coverage.html (last visited dec. 28, 2013). 197 durable medical equipment fraud, neb. dep't of health and human servs., http://dhhs.ne.gov/medicaid/documents/ factsheetdmefraud.pdf. 198 patient protection and affordable care act of 2010 § 6407 (codified as amended at 42 u.s.c. §§ 1395f, 1395m, 1395n (2013)). 199 id. 200 press release, 13-840, u.s. dep't of justice, owner of california medical equipment supply company found guilty of $11 million medicare fraud scheme (july 24, 2013), available at 276 vol. 11:1 accountability partners however, now, in order for an individual to receive dme, the individual must have a face-to-face encounter with a physician, nurse practitioner, clinical nurse specialist, or a physician assistant.201 such a simple requirement eliminates opportunities to provide dme to dead patients or to patients who never wanted the dme at all. this law also applies to home health services in which an individual must receive orders for home health services from a physician.202 in hospice facilities, the affordable care act implemented a required visit pursuant to which a practitioner must certify that the resident is eligible for hospice through a face-toface meeting.203 finally, the affordable care act also brought about changes intended to reduce opportunities for fraud in nursing homes. in particular, skilled nursing facilities must now operate a compliance program, and background checks are required for direct patient access employees. 204 although these high-risk areas required changes to address accountability and transparency among healthcare entities, the affordable care act also brought about changes geared toward all providers and practitioners that interact with federal healthcare programs. with respect to funding to enforce fraud and abuse laws, the affordable care act has increased funding to identify and prosecute potential fraudulent activity. one of the primary mechanisms is an increase in funding for fraud enforcement efforts for the decade following enactment.205 between 2011 and 2020, the affordable care act has http://www.justice.gov/opa/pr/2013/july/13-crm-840.html (last visited dec. 28, 2013) ("the trial evidence showed that [the defendants] submitted more than $11 million in fraudulent claims from ibon and bonfee to medicare for expensive, high-end power wheelchairs, hospital beds, braces and other dme that customers either did not need or receive.") 201 patient protection and affordable care act of 2010 § 6407 (codified as amended at 42 u.s.c. §§ 1395f, 1395m, 1395n (2013)). 202 id. 203 id. § 3132 (codified as amended at 42 u.s.c. § 1395f (2013)). 204 id. § 6201 (codified as amended at 42 u.s.c. § 1320a-7](2013)). 205 id. § 6402 (codified as amended at 5 u.s.c. § 552a (2013) and scattered sections of 42 u.s.c.). 2014 277 indiana health law review increased funding by $10 million annually. 206 in addition, the affordable care act provided mandatory appropriations of $1.7 billion in both 2010 and 2011 to fund fraud enforcement through various agencies. 207 these actions have greatly increased the enforcement mechanisms to catch fraud and abuse in federal healthcare programs. what is the goal of all of this spending? recovery of additional funds to help pay for portions of the affordable care act. 20 8 in addition to funding, additional laws were created with respect to anti-kickback violations. the anti-kickback statute is a powerful fraud enforcement mechanism because it relates to knowing violations in which people or organizations are seeking to commit fraud against federal healthcare programs. 209 the statute prohibits knowingly and willfully paying or receiving payments for any service or treatment when the payment is made by a federally funded healthcare program such as medicare or 206 id. 207 hearing on efforts to combat health care fraud and abuse before the subcomm. on labor, health and human servs., education, and related agencies h comm. on appropriations, 111th cong. (2010) (statement of william corr, deputy secretary, u.s. department of health and human services.), available at http://www.hhs.gov/asl/testify/2010/03/t20100304a.html (last revised june 18, 2013). 208 see id. ("the obama administration is focused on reducing all improper payments in federal programs, whether the result of criminal intent, greed or inefficiencies. so the fiscal year (fy) 2011 budget request to the congress covers all types of fraud and abuse, as well as other categories of improper payments. with this funding request, we will be adding resources to law enforcement and program oversight, as well as to program integrity operations in the centers for medicare & medicaid services (cms). to demonstrate our commitment, the fy 2011 budget includes a record $1.7 billion to fight waste, fraud, and other improper payments. this includes $561 million in discretionary funding, a $250 million increase over fy 2010. projecting this discretionary investment over 10 years, together with new program authorities and administrative actions proposed in the budget, will save nearly $25 billion in medicare and medicaid expenditures over 10 years."). 209 see generally criminal penalties for acts involving federal health care programs, 42 u.s.c. § 1320a-7b(b) (2013). 278 vol. 11:1 accountability partners medicaid. 210 this criminal act can result in a conviction if the defendant knowingly and willfully, solicits or receives remuneration in return for a referral. 211 because this is a criminal penalty, the penalties consist of $25,000 and imprisonment for up to five years for each offense. 212 like many of these laws, there are many safe harbor provisions covering a variety of arrangements, including investment interests, sales of practices, malpractice insurance, contracts for space or equipment, advertisements and promotions, and many others. 213 however, even the antikickback statute can be tough to enforce because of the requirement to show knowing or willful violations. the affordable care act added a slight change to how the anti-kickback statute applies, resulting in an easier road to establishing anti-kickback claims. in particular, the affordable care act amends the anti-kickback statute to provide that "a claim that includes items or services resulting from a violation constitutes a false or fraudulent claim for purposes of the" false claims act. 2 14 any violation of the anti-kickback statute will now transform into a false claim under the false claims act. this is important because it opens up the door to whistleblower provisions provided under the false claims act in which individuals may bring actions on behalf of the government (and share in any monetary recovery).215 to put the importance of this into perspective, the federal government 210 id. 211 id. 212 id. 213 exceptions, 42 c.f.r. § 1001.952(a) (2013). 214 patient protection and affordable care act of 2010, pub. l. 111148, § 6402, 124 stat. 119-1025 (2010) (codified as amended at 5 u.s.c. § 552a (2013) and scattered sections of 42 u.s.c.). 215 false claims act, 31 u.s.c. §§ 3729-33 (2013). see generally geneva campbell, comment: snitch or savior? how the modern cultural acceptance of pharmaceutical company employee external whistleblowing is reflected in dodd-frank and the affordable care act, 15 u. pa. j. bus. l. 565 (2013); timothy stoltzfus jost, optimizing qui tam litigation and minimizing fraud and abuse: a comment on christopher alexion's open the door, not the floodgates, 69 wash. & lee l. rev. 419 (2012). 2014 279 indiana health law review has recovered nearly $22 billion under the false claims act between 1987 and 2008.216 not only did the affordable care act expand the ease in which a violation of the antikickback statute may constitute a false claim, but the affordable care act creates a stronger enforcement vehicle under the false claims act to pursue potential overpayments as well. under the false claims act pre-affordable care act, the public disclosure bar prohibited individuals from filing suits based on fraudulent activity unless that individual was the original source of the information that provided the foundation of the suit.217 under the affordable care act, this concept was narrowed. in particular, these types of suits are barred now only when the same allegations were already publicly disclosed in a federal criminal, administrative, or civil hearing, or another form of federal hearing or investigation, or by the media.218 in addition, the original source definition was broadened to include any individual who has knowledge that is "independent and materially adds to the publicly disclosed allegations or transactions and who voluntarily provided the information to the government."219 by widening the road for whistleblowers, the affordable care act will broaden the scope of claims brought under the false claims act. c. physician accountability and conflicts ofinterest in addition to the focus on health insurers, high-risk areas, and general fraud and abuse provisions, the affordable care act has extended the focus of accountability and transparency to physicians. this expansion centers upon physician-owned hospitals, physician investment interests, disclosure requirements regarding the stark law, 216 u.s. dep't of justice, fraud statistics 1986-2008, available at http://www.justice.gov/opalpr/2008/november/fraud-statisticsl9862008.htm (last visited dec. 29, 2013). 217 31 u.s.c. §§ 3729-33. 218 patient protection and affordable care act of 2010 § 10104(j)(2) (codified as amended at 31 u.s.c. § 3730 (2013)). 219 31 u.s.c. § 3730. 280 vol. 11:1 accountability partners and prescription drug samples. 220 these provisions focus on a higher level of transparency within the practice of medicine, and an attempt to limit conflicts of interest. although other laws such as the stark law and the antikickback statute work to curb such abuses, these additional provisions provide substantial movement forward in a more transparent and accountable system. with respect to physician-owned hospitals, these facilities expanded rapidly from 2002 to 2010.221 specifically, there were forty-six physician-owned hospitals in 2002, and that number ballooned to 265 by 2010.222 "for years critics have complained that when doctors invest in hospitals, conflicts of interest arise that could endanger patients and threaten the survival of general hospitals."2 23 the issue is divisive, and others argue that physician-owned hospitals provide valuable tax revenue to the government. the physician hospitals of american reported that each physician-owned hospital paid $3 million per year in taxes.224 although the issue of whether physicians should own hospitals has many critics on both sides, congress, in passing the affordable care act, effectively decided that physicians could no longer own hospitals.225 under the affordable care act, new physician-owned hospitals are forbidden, and existing physician-owned hospitals generally can no longer expand their facility capacity; however, hospitals may still be owned even after the law if they have a provider agreement prior to february 220 see generally patient protection and affordable care act of 2010 §§ 6001-05 (codified as amended at 42 u.s.c. §§ 1395nn, 1320a-7h, 1320a-7i, 1320b-23 (2013)). 221 medicare payment advisory comm'n, report to the congress: physician-owned specialty hospitals revisited 3-4 (2006), available athttp://www.medpac.gov/documents/ aug06_specialtyhospital-mandated-report.pdf. 222 id at 6. 223 should doctors own hospitals?, bloomberg bus. wk. (feb. 19, 2006), http://www.businessweek.com/stories/2006-0219/should-doctorsown-hospitals. 224 id. at 7. 225 patient protection and affordable care act of 2010 § 6001 (codified as amended at 42 u.s.c. § 1395nn (2013)). 2014 281 indiana health law review 2010.226 this prohibition on the expansion or ownership of physician-owned hospitals largely dealt with conflict of interest issues. 227 in addition to prohibiting physician-owned hospitals, the government has also attempted to deter conflicts of interests with respect to physicians' investment interests. 228 this includes additional reporting requirements for physicians regarding their investment and ownership interests because physicians receive different forms of remuneration that may create conflicts of interest from medical device and pharmaceutical companies. 229 medical device and pharmaceutical companies must now report annually any investment and ownership interests a physician might have. 230 the affordable care act also requires that any gifts from medical device and pharmaceutical companies to physicians must be reported.231 this largely is meant to curb any conflicts that may arise when gifts may create an allegiance to a specific provider even though such supplies and services may not be medically necessary. 232 physician accountability and transparency is also targeted with respect to medical imaging services. under the affordable care act, disclosure is required for physicians regarding medical imaging services that are excluded from the stark in-office ancillary services 226 id. 227 see generally joshua e. perry, physician-owned specialty hospitals and the patient protection and affordable care act: health care reform at the intersection of law and ethics, 49 am. bus. l.j. 369 (2012). 228 patient protection and affordable care act of 2010 § 6002 (codified as amended at 42 u.s.c. § 1320a-7h (2013)). 229 id. 230 id. 231 id. § 6004 (codified as amended at 42 u.s.c. § 1320a-7i (2013)). 232 see generally inst. of med., conflict of interest in medical research, education, and practice (bernard lo & marilyn j. field, eds., 2009); medicare payment advisory comm'n, report to the congress: reforming the delivery system (2008), available at http://www.medpac.gov/documents/jun08_entirereport.pdf. 282 vol. 11:1 accountability partners exception. 233 now, physicians that have ownership interests in these services must notify referred patients in writing of that interest. 234 these provisions regarding physicians have many different aims. first, physicians ultimately control the services patients require. although there is a substantial amount of trust with physicians, the affordable care act acts to curb any forms of conflict that may arise. ultimately, by limiting potential conflicts, the government is attempting to create more accountability by these decision-makers. second, the government recognized that steps such as these may be necessary to' create a more transparent healthcare system. in part, these laws force physicians and other providers to make decisions dependent on whether a procedure is medically necessary rather than whether there are questions of allegiance, investment, or ownership interests. finally, the ultimate goal is to develop a system in which patients, the government, and insurers can rely on physicians to make the right decisions. under the affordable care act, third party payors, physicians, and many parties that interact with the healthcare system are now being held more accountable by the federal government. with respect to health insurance companies, the programs and laws implemented under the affordable care act have far reaching implications for accountability and transparency within the insurance industry. in addition, the affordable care act has also strengthened many of the existing fraud and abuse laws and added additional funding to curb healthcare fraud across the spectrum of healthcare participants. finally, the focus on physicians is aimed at developing a transparent decision making process based on the best decision for the patient with the hope of eliminating conflicts. by creating transparency among insurers and physicians, and by strengthening the fraud abuse enforcement mechanisms, the federal government is now able to hold all healthcare 233 patient protection and affordable care act of 2010 § 6003 (codified as amended at 42 u.s.c. § 1395nn (2013)). 234 id. 2014 283 indiana health law review participants more accountable for their decisions in hopes of a more transparent and efficient system. v. accountability among providers a. a brief history-us. health system as a fragmented model the affordable care act's idea of accountability encourages collaboration and requires providers to share in the costs and risks associated with health outcomes of a community of patients. however, the idea of an accountable group or large organization was less systematic and coordinated prior to the enactment and roll out of the affordable care act.23 5 the story of the american healthcare system is one of many actors attempting to deliver care to patients throughout the country with little coordination. 2 36 the united states healthcare system prior 235 arthur garson, jr., the us healthcare system 2010, 101 j. am. heart ass'n 2015 (2000), available at http://circ.ahajournals.org/content /101/16/2015.full.pdf+html ("ten years ago, the us healthcare system was declared 'broken,' and it has not improved. fixes promised by managed care have not materialized. premiums are rising. hassles for patients and physicians abound. nearly 45 million americans are uninsured."). 236 cathy schoen et al., us. health system performance: a national scorecard, 25 health aff. 457 (2006), available at http://content.healthaffairs.org/content/25/6/w457.full.pdf. the authors explain that "[cloordination of care is particularly critical during transitions following hospital discharge. yet hospitalized patients in the united states are less likely to have medications reviewed when discharged than is the case in several other countries. across the united states, patients discharged from the hospital with chf receive written discharge instructions only 50 percent of the time, on average, and there is an eighty-percentage-point spread between the top and bottom 10 percent of hospitals and a forty-percentage-point spread between the top and bottom 10 percent of states (64 percent versus 26 percent, data not shown). patients hospitalized for mental health conditions often do not receive follow-up care within thirty days of discharge. on both chf and mental illness indicators, there is a gap of twenty to thirty percentage points between national averages and rates achieved by the top group of hospitals or health plans. these shortcomings put patients at risk for complications and readmissions and raise the cost of care." id. 284 vol. 11: 1 accountability partners to the affordable care act was disjointed and lacked these coordination and systematic accountability components. this lack of accountability and coordination reached to all providers, including hospitals, physicians, nurse practitioners, physician assistants and other healthcare providers. under the model of healthcare delivery pre-affordable care act, the healthcare system created many inefficiencies and complexities. 23 7 for example, in some areas of the country, medicare spending was lower at the same time that a higher quality of care and better outcomes were achieved. 238 largely, these differences in geographic areas led some to argue that additional spending in higher cost regions was a product of greater use of hospitals, more frequent referrals and greater use of testing and minor procedures. 239 in addition to the inefficiencies in overall costs regionally, u.s. healthcare spending highlights levels of waste in areas in which better coordination and accountability can reduce spending.240 estimates suggest that up to $520 billion in savings are possible due to hospital inefficiencies, unnecessary care, uncoordinated care, and avoidable care. 241 in a study developed by the centers for disease control and prevention, it was estimated that the healthcare system lacked focus on serious preventive care services, which could prevent heart 237 e.a. mcglynn et al., the quality of health care delivered to adults in the united states, 348 new eng. j. med. 2635 (2003) (acknowledging the complex fragmented healthcare delivery system). 238 katherine baicker & amitabh chandra, medicare spending, the physician workforce, and beneficiaries' quality of care, 23 health aff. w184 (2004), available at http://content.healthaffairs.org/content/ early/2004/04/07/hlthaff.w4.184.full.pdf. 239 cong. budget office, geographic variation in health care spending (2008). 240 waste measurements, economist (june 17, 2011, 3:02 pm), http://www.economist.com/blogs/dailychart/2011/06/us-health-carespending. 241 id. 2014 285 indiana health law review disease and increased cancer risk.2 42 the overall lack of focus on preventive care, increasing accountability, and decreasing inefficiencies has resulted in many of the problems that compelled the clamoring for greater reform. however, one of the largest problems with the pre-health reform delivery system related to the responsibility and accountability of individual providers to each other. for example, according to the medical group management association, nearly 70% of physicians were in their own practices rather than in hospitals in 2005.243 physicians often preferred the independence associated with their own practices rather than to be subject to the oversight of the large local hospital, which increasingly is a subsidiary organization to a much larger health system entity. independence and collaboration are often at a crossroads. this lack of collaboration may have been to the detriment of coordinated care, but collaboration and cost containment may not carry the link that was assumed. consolidation of physician practices has yet to yield lower costs. 244 in fact, in many areas, consolidation may be increasing coordination of care but also increasing the costs of healthcare. 245 another day-to-day operational issue among providers is the necessary collaboration between physicians, nurse practitioners, and physician assistants. 246 with an additional 30 to 33 million newly-insured people seeking 242 ctrs. for disease control and prevention, use of selected clinical preventive services among adults united states, 20072010, (2012), available at http://www.cdc.gov/mmwr/pdflother/su6102. pdf. 243 gardiner harris, more doctors giving up private practices, n.y. times (mar. 25, 2010), http://www.nytimes.com/2010/03/26/ healthlpolicy/26dos.html?pagewanted=all&_r=0. 244 id. 245 robert a. berenson et al., unchecked provider clout in california foreshadows challenges to health reform, 29 health aff. 1, (2010), available at http://content.healthaffairs.org/content/early/ 2010/02/25/hlthaff.2009.0715.full.pdf. 246 lora hine, nurse practitioners help ill critical shortage of health care professionals, chron (june 21, 2013), available at http://www.chron.com/health/article/nurse-practitioners-help-fillcritical-shortage-4614372.php (last updated june 21, 2013, 11:34 am). 286 vol. 11:1 accountability partners care once the affordable care act is fully implemented in 2016, more people will be sitting in waiting rooms of doctor's offices for appointments. 24 7 with this increase in patients, physician groups and other trade organizations have also analyzed their ability to provide care. 24 8 according to the association of american medical colleges, there will be a shortage of 91,500 physicians by 2020, resulting in various practitioners needing to work together to service communities. 249 overall, the affordable care act has impacted a system in which nurse practitioners and physician assistants previously had less autonomy. but the new populations seeking care will require these nonphysician practitioners to work and collaborate with physicians. passage of the affordable care act means that millions more people are covered, but will there be enough providers to take care of these additional patients? 250 do we expand the scope of practice for other practitioners such as physician assistants or nurse practitioners? do we change reimbursement models to include other providers as primary care providers? should physicians lead the specialists in the delivery of care? these questions each have divisive answers from all sides. the affordable care act charged through these roadblocks and acted as an impetus to ensure that these different providers work together to better coordinate care for millions across the country. 247 see rachel nardin et al., the uninsured after implementation of the affordable care act: a demographic and geographic analysis, health aff. blog (june 6, 2013), http://healthaffairs.org/blog/2013/06/ 06/the-uninsured-after-implementation-of-the-affordable-care-act-ademographic-and-geographic-analysis/. 248 physician shortages to worsen without increases in residency raining, am. ass'n med. cs., https://www.aamc.org/download/286592/ data/. 249 id. 250 david troxel, op-ed., doctor shortage looms in health care reform, livescience (june 14, 2013, 6:14 pm), http://www.livescience.com/37468-doctor-shortage.html. 2872014 indiana health law review b. promoting accountability among providers the enactment of the affordable care act has resulted in several areas that impact, either directly or indirectly, the accountability of providers and practitioners. directly, the affordable care act works to strengthen primary care for the communities that providers serve. the impact on primary care requires providers to be accountable for preventing healthcare events rather than simply treating illnesses and events once they occur. also, by strengthening primary care, the affordable care act has brought to the forefront delivery models in which providers must work together to care for patients through patient centered medical homes. finally, the affordable care act implemented incentives for physicians, nurse practitioners, and other providers to choose primary care rather than other higher paying specialties addressing the current fragmentation among provider specialties. with respect to patient care models, the affordable care act strengthens cooperation and collaboration among providers by incentivizing teamwork and accountability. one of the primary examples of these types of models includes increased funding for community health centers. 251 in many community health centers, providers are reimbursed at the same rates, unlike in other settings, and teamwork, accountability, and collaboration are the only effective means in which these organizations can service their communities. finally, one of the largest and most well-known changes that impacts the accountability and collaboration of providers relates to the implementation of accountable care organizations. 2 52 in these organizations, the goals is to align incentives so that providers can share 251 public health service act, pub. l. no. 78-410, § 330, 58 stat. 682 (1944) (codified as amended at 42 u.s.c. § 254b (2013)), amended by patient protection and affordable care act of 2010, pub. l. no. 111148, § 10406, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 254b-2 (2013)), amended by healthcare and education reconciliation act, pub. l. 111-152, 124 stat. 1029-84 (2010). 252 patient protection and affordable care act of 2010 § 3022 (codified as amended at 42 u.s.c. § 1395jjj (2013)). 288 vol. 11.1 accountability partners in the savings brought about by higher quality and more coordinated care. c. strengthening 'primary care" the affordable care act has instituted collaboration and accountability among providers and practitioners through various incentive programs that strengthen primary care. by strengthening primary care services in the healthcare system, the affordable care act implemented a standard of services that will provide substantial benefits to facilitating coordination across the continuum of care. through the funding of patient centered medical homes, new payment models and additional funding for the training of many different practitioners, the affordable care act acts to reach these goals. "primary care" is a term often misunderstood by the public, although most patients commonly experience it whenever they receive treatment from a family physician. if someone has ever sought treatment for symptoms of the flu, needed routine tests, or required education regarding his or her healthcare, he or she has likely experienced "primary care." one definition is that "primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community."253 however, other definitions are much more expansive, such as the definition from the american academy of family physicians: primary care is that care provided by physicians specifically trained for and skilled 253 comm. on the future of health care workforce for older ams., inst. med. of the nat'l academies, retooling for an aging america: building the health care workforce 27 (2008), available at http://www.iom.edu/-/media/files/report%20files/2008/retooling-foran-aging-america-building-the-healthcare-workforce/ reportbriefretoolingforanagingamericabuildingthehealthcareworkfo rce.pdf. 2014 289 indiana health law review in comprehensive first contact and continuing care for persons with any undiagnosed sign, symptom, or health concern (the "undifferentiated" patient) not limited by problem origin (biological, behavioral, or social), organ system, or diagnosis. primary care includes health promotion, disease prevention, health maintenance, counseling, patient education, diagnosis and treatment of acute and chronic illnesses in a variety of health care settings (e.g., office, inpatient, critical care, long-term care, home care, day care, etc.). primary care is performed and managed by a personal physician often collaborating with other health professionals, and utilizing consultation or referral as appropriate. primary care provides patient advocacy in the health care system to accomplish cost-effective care by coordination of health care services. primary care promotes effective communication with patients and encourages the role of the patient as a partner in health care.2 54 here, this definition specifically refers to the role of physicians. however, the role of primary care and the various types of healthcare providers delivering that care is substantially changing. the affordable care act's first method of strengthening primary care and accountability of providers deals with the implementation and support of patient-centered medical homes. the affordable care act established a center for medicaid and medicare innovation to develop care models "promoting broad payment and practice reform in primary care, including the patient-centered medical home 254 primary care, am. acad. fam. physicians, http://www.aafp.org/online/en/home/policy/policies/p/primarycare.html (last visited dec. 29, 2013). 290 vol. 11:1 accountability partners models."255 this promotes models in which "a close relationship between care coordinators, primary care practitioners, specialist physicians, community-based organizations, and other providers of services and suppliers" can work together. 256 in particular, patient-centered medical homes "include enhanced patient access to a regular source of primary care, stable and ongoing relationships with a personal clinician who directs a care team, and timely, well-organized health services that emphasize prevention and chronic care management."257 this concept, although fluid in its process and delivery, has been estimated to reduce spending by an estimated $175 billion through 2020.258 generally though, the patient-centered medical home concept develops strong accountability and collaboration between various providers. one of the first patient-centered medical home practice sites was set in the state of washington. 259 the journal of ambulatory care management published a case study about the implementation of such a concept. 260 the model was spread to a set of twenty-six primary care practices in fourteen months, reaching more than 600,000 patients and ranging to both urban and rural settings.261 the various clinics implemented staffing changes, which increased the roles of physician assistants, nurse practitioners, registered 255 patient protection and affordable care act of 2010§ 3021(a) (codified as amended at 42 u.s.c. § 1315a (2013)). 256 id. 257 karen davis et al., supra note 76, at 1201-03. 258 the path to a high performance us. health system: a 2020 vision and the policies to pave the way, commonwealth fund comm'n on high performance health sys. (2009), http://www.commonwealthfund.org/~/media/files/publications/fund%20 report/2009/feb/the%2opath%20to%20a%2ohigh%20performance%20 us%20health%2system/1237commission-path-highperformus-h t_syswebrev_03052009.pdf. 259 clarissa hsu et al., spreading a patient-centered medical home model, 35 j. ambulatory care mgmt. 99, available at https://primarycare.hms.harvard.edulsites/default/files/j%2amb%20ca re%20mgmt%202012%2ocase%2study-1.pdf (last visited july 18, 2013). 260 id. 261 id. at 100-01. 2014 291 indiana health law review nurses, and pharmacists, in general nearly doubling their numbers in practices led by physicians. 262 in another report analyzing the results of a patientcentered medical home, the commonwealth fund formulated a report discussing a pilot project in pennsylvania. 26 3 after one year of the study, impressive improvements showed a 20% reduction in hospital admissions and a 12% reduction in readmission rates. 264 one impediment to the establishment of such homes is that of collaboration 265 among providers; however the amount of collaboration and accountability among providers has increased substantially, and, under the guidance of the affordable care act, this accountability among providers has yielded impressive results. another avenue in which the affordable care act has both strengthened primary care and instituted accountability among providers is through incentives to multiple types of primary care practitioners. first, the affordable care act instituted accountability among providers by defining "primary care provider" in professionneutral terms (i.e., not only physicians). under the affordable care act, a "primary care provider" means: a clinician who provides integrated, accessible health care services and who is accountable for addressing a large majority of personal health care needs, including providing preventive and health promotion services for men, women, and children of all ages, developing a sustained partnership with patients, and practicing in the context of family and 262 id. at 101-05. 263 hearing on 'person -centered care: reforming services and bringing older citizens back to the heart of society" before the special s. comm. on aging, 110th cong. (2008) (invited testimony by melinda k. abrams, assistant vice president, the commonwealth fund). 264 id. 265 see andis robeznieks, sore subject: nurses react as aafp report backs doctor-led medical homes, modernhealthcare.com (oct. 6, 2012), http://www.modernhealthcare.com/article/20121006/ magazine/310069966. 292 vol. 11:1 accountability partners community, as recognized by a state licensing or regulatory authority, unless otherwise specified in this section. 266 this is significant because one step in developing a system in which providers and practitioners work together relates to defining those providers. d. payment models promoting accountability among providers however, payment models also impact the ways in which providers will work together to strengthen primary care and develop more accountability among their team. the affordable care act created the incentive payment program for primary care services. 267 this payment incentive applies to primary care physicians specializing in family medicine, internal medicine, geriatric medicine, or pediatric medicine. 268 it also applies to nurse practitioners, clinical nurse specialists, and physician assistants who provide at least 60% of their charges in primary care.26 9 in other words, physicians and non-physicians are targeted for the incentive. the payment incentive provides a 10% increase in payment for primary care practitioners for allowable primary care services. 270 by aligning incentives among various providers, the implementation of payment incentive programs ultimately requires various practitioners to be accountable to one another in the provision of primary care services. in addition to increased reimbursements that incentivize provider cooperation and collaboration, the affordable care 266 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 5405, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 280g-12(a)(3)(b) (2013)) (emphasis added). 267 id. § 5501(a) (codified as amended at 42 u.s.c. §§ 13951, 1395m, 1395w-4 (2013)). 268 id. 269 id. 270 id. 2932014 indiana health law review act implemented various funding opportunities for increasing the healthcare workforce.271 first, funding for the national health service corps was permanently authorized. 272 in particular, the funding allows student loan repayments for physicians, dentists, nurse practitioners, midwives, and physician assistants whom agree to serve in designated health professional shortage areas. 273 these areas include both rural and underserved areas in which providers are accountable to one another for maintaining the health of communities in which health services are scarce. 274 also, the affordable care act implemented funding for primary care training programs for physicians, nurse practitioners, and physician assistants.275 first, the affordable care act authorized grants to support training programs to create academic units to enhance interdisciplinary training for both physicians and physician assistants. 276 these training programs apply to medical schools and physician assistant training programs associated with academic institutions.277 also, the affordable care act specifically included funding for nurse practitioner training programs to increase nurse practitioners in the workforce. 278 the goal is two-fold. first, this inevitable relates to increasing the workforce, but more importantly the affordable care act addresses that 271 c. stephen redhead et al., cong. research serv., r41390, discretionary funding in the patient protection and affordable care act (2011), available at http://www.ncsl.org/documents/health/ disfundingaca.pdf. 272 patient protection and affordable care act of 2010 § 5207 (codified as amended at 42 u.s.c. § 254q (2013)). 273 id. 274 see generally shortage designation: health professional shortage areas & medically underserved areas/populations, health res. & servs. admin., u.s. dep't health & hum. servs., http://www.hrsa.gov/shortage/ (last visited dec. 29, 2013). 275 patient protection and affordable care act of 2010 §§ 5301, 5312 (codified as amended at 42 u.s.c. §§ 293k, 298d (2013)). 276 id. § 5301 (codified as amended at 42 u.s.c. § 293k (2013)). 277 id 278 id. § 5312 (codified as amended at 42 u.s.c. § 298d (2013)). 294 vol. 11:1 accountability partners multiple providers must be trained in primary care to service communities together. finally, the affordable care act authorized family nurse practitioner demonstration programs.2 79 under these demonstration programs, nurse practitioners will be trained as primary care providers in federally qualified health centers and nurse-managed health clinics. 280 the health resources and services administration explained that this support in nurse-managed health clinics will "improve access to primary care . . . [and] serve as primary care access points in areas where primary care providers are in short supply."281 these demonstration programs further highlight the affordable care act's incentives to create accountability among various practitioners. e. organizational accountability in addition to the affordable care act incentivizing teamwork and accountability among practitioners through payment models and training programs, the affordable care act also addresses accountability through incentivizing organizations to challenge practitioners to collaborate and provide care more efficiently with one another. in particular, the affordable care act focused efforts on organizational change to promote accountability not only between individual practitioners and their employers, but also between the practitioners themselves. the affordable care act does this in two important ways. first, the affordable care act has instituted change through additional funding for chcs. second, the affordable care act has developed new methods of care delivery through the creation of acos. 279 id. § 5316 (codified as amended at scattered sections of 42 u.s.c.). 280 id. 281 see nurse managed health clinics (nmhc), health res. & servs. admin., u.s. dep't health & hum. servs., http://bhpr.hrsa.gov/nursing/grants/nmhc.html (last visited dec. 29, 2013). 2014 295 indiana health law review according to the health resources and services administration, chc's "have become the essential primary care medical home for millions of americans including some of the nation's most vulnerable populations." 282 specifically, the affordable care act authorizes operating grants to chcs throughout the united states to furnish comprehensive primary care services to patients, regardless of their ability to pay.28 3 facilities such as these offer a substantial opportunity to facilitate change in the ways in which practitioners interact and provide accountability to one another. for example, according to the center for studying health system change, fqhcs support this interaction "especially through their primary care teams of physicians and midlevel providers, such as nurse practitioners and ppaca provisions will likely support their continued role."284 finally, the affordable care act institutionalized a care model that requires practitioners and providers to be accountable to one another. this care model is known as an aco developed under the medicare shared savings program. 285 indeed, the word "accountable" itself is embedded within the very name of this model. this is notable because it highlights the level of focus placed on accountability. the goal of acos in the medicare shared savings program is for "groups of providers of services and suppliers meeting criteria specified by the secretary [to] work together to manage and coordinate care for medicare feefor-service beneficiaries through an accountable care 282 the affordable care act and health centers, health res. & servs. admin., u.s. dep't health & hum. servs., http://bphc.hrsa.gov/about/healthcenterfactsheet.pdf. 283 patient protection and affordable care act of 2010, pub. l. no. 111-148, § 5601, 124 stat. 119-1025 (2010) (codified as amended at 42 u.s.c. § 254b (2013)). 284 aaron katz et al., a long winding roadfederally qualified health centers, community variation and prospects under reform, 21 center for studying health sys. change: res. brief 1, (2011), available at http://www.hschange.com/content/1257/1257.pdf. 285 patient protection and affordable care act of 2010 § 3022 (codified as amended at 42 u.s.c. § 1395jjj (2013)). 296 vol. 11: 1 accountability partners organization."286 however, the definition of an aco is a fluid concept in that there are multiple approaches. generally, though, according to the national institute for health care reform, "acos will constitute groups of providers-physicians, other clinicians, hospitals or other providers-that together provide care and share accountability for the cost and quality of care for a population of patients."287 some associate the aco model with current business models in different industries. harold miller, president and ceo of the network for regional healthcare improvement and executive director of the center for healthcare quality & payment reform in pittsburgh, explains that we should "think of it as buying a television" in that: a tv manufacturer like sony may contract with many suppliers to build sets. like sony does for tvs . . . an aco would bring together the different component parts of care for the patient primary care, specialists, hospitals, home health care, etc.2 88 however, miller notes, "acos will need to prove that the overall health care product they're creating does work better and costs less in order to encourage patients and payers to buy it."289 the aco model is unique in that it provides "financial incentives for broad cost containment and quality 286 id. 287 timothy k. lake et al., lessons from the field: making accountable care organizations real, nat'l inst. for health care reform (jan. 2011), available at http://www.niher.org/accountablecare-organizations.html. 288 jenny gold, faq on acos: accountable care organizations, explained, kaiser health news (aug. 23, 2013), http://www.kaiserhealthnews.org/stories/2011/january/13/acoaccountable-care-organization-faq.aspx. 289 id. 2014 297 indiana health law review performance across multiple sites of care."2 90 thus there is now a financial incentive for primary care providers, specialists, and hospitals to work in a more integrated and cost-effective way. this includes new payment approaches aimed at sharing the cost between multiple providers ending in one common billing approach.291 generally, an aco will share responsibility for treating a group of patients. these shared and collective approaches create a system built on changing the way healthcare is delivered in the united states. the national institute for health care reform analyzed seven healthcare organizations developing as acos. in this study, the organizations included "three integrated delivery systems, one physician-hospital organization (pho), two medical groups one large and one small group owned by a hospital and one management services organization (mso) affiliated with four independent practice associations."292 the study itself analyzed some of the major challenges that current systems are facing when attempting to transition to the aco model. however, it is important to note that each of these organizations are quite different from one another, highlighting the flexibility needed when transitioning to an aco model. nonetheless, the study resulted in four major challenges to these changes. first, funding was a major issue for each of these systems. 293 the main problem is that the "improvements required substantial investment, both in time and money. many funded these activities through existing reserves, while others . . . applied for and received grant funding."294 this creates a risk where certain systems do not have the capital to make these changes, and where others have utilized grant allocation to the maximum possible degree. second, these organizations experienced a 290 marsha gold, accountable care organizations. will they deliver., mathematica pol'y res., inc. 1 (2010), available at http://www.mathematica-mpr.com/publications/pdfs/health/ account-care-orgs brief.pdf. 291 id. 292 lake et al., supra note 287. 293 id. 294 id. 298 vol. 11:1 accountability partners huge amount of resistance to change.295 generally, this is an internal issue that is challenging within any organization that is changing. however, the model itself necessitates change. other challenges facing the transition were potential disruptions to productivity and limited infrastructure to pursue these changes. 296 the issue of disruptions to productivity was a major issue because the process required changes in workflow and different staff responsibilities. 2 97 additionally, infrastructure issues were fueled by the lack of ability to measure and track performance. 298 systems explained that it was necessary to use reliable data at all times; however, privacy issues required legal advice to continue with the transition. 299 nonetheless, throughout united states healthcare history, there have been varying models aimed at minimizing costs. this current model represents a major transition and the first step towards reaching the goal of accountability among providers, practitioners, and organizations. a more recent report regarding the pioneer aco program described the successes and pitfalls of some of the first acos organized under the affordable care act. 300 under the pioneer aco program, thirty-two acos were formed to provide care for more than 669,000 beneficiaries. 3 01 overall, under these acos, costs grew by 0.3% in 2012 compared to 0.8 for similar beneficiaries. 3 02 these acos earned over $76 million for their efforts in cost 295 id. 296 id. 297 id. 298 id. 299 id. soo press release, ctrs. for medicare & medicaid servs., details for yytle: pioneer accountable care organizations succeed in improving care, lowering costs (july 16, 2013) [hereinafter press release, cmms], available at http://www.cms.gov/newsroom/ mediareleasedatabase/press-releases/2013-press-releases-items/201307-16.html (last visited dec. 29, 2013). 301 id.; lake et al., supra note 287. 302 press release, cmms, supra note 301; lake et al., supra note 287. 2014 299 indiana health law review savings; however two acos shared losses totaling $4.0 million.303 although the fragmented united states healthcare systems continues to experience change, the affordable care act helped institute more accountability among the many players in the healthcare service industry. the affordable care act implemented laws that impact the way teams of providers work together to provide care. in addition, primary care has been a focus point within the legislation that further allows providers the ability to work together and remain accountable to each other. finally, the affordable care act provides the proper incentive through payment models and organizational accountability to influence drastic changes in the ways in which providers, practitioners, and organizations interact. vi. conclusion the public's perception of the affordable care act centered around the "hot button" issues. these included the "individual mandate," whether the federal government had the constitutional authority to require citizens to purchase health insurance, issues of health insurance exchanges and employer participation in health insurance. aside from these more public topics, the subtle shift toward an accountable system designed to lower cost and improve quality appears to be lost in this debate, or at the very least muffled. also missing in this conversation is the very word in which the legislation was designed to symbolize: "accountability." in many ways, the affordable care act's aims are more about requiring accountability among healthcare participants than about the publicly-discussed issues in which talk shows have developed sound bytes and political parties have been divided. of all of the changes effectuated under the affordable care act, accountability will become the benchmark for evaluating whether providers, patients, and the federal government have pursued the proper course 303 press release, c1ims, supra note 301; lake et al., supra note 287. 300 vol. 11: 1 2014 accountability partners 301 in the twenty-first century. it is these lesser-known "accountability" provisions that offer the hope of shifting the healthcare system into a more efficient and accountable organism. the need for decreasing costs, increasing quality, and expanding access can only be met with accountability because, without groups partnering together, patients holding their providers accountable, and the government ensuring a more transparent system, the integrity of the healthcare system cannot be maintained. the hope of an improved, sustainable healthcare delivery system, where improved healthcare is available for individuals and larger populations at a per-capita lower cost, is built upon a sustainable foundation: accountability. “standing on the shoulders of a giant” nicolas p. terry* it was a great honor when eleanor passed me the keys to the william s. and christine s. hall center for law and health. her handoff of the center was generous. i also was first treated to meals at her favorite breakfast and lunch places in downtown indianapolis” the hall center was established in 1987 and in 2003 the first edition of the indiana health law review was published. by 2011, the hall center was a vibrant place. the core components of a leading health law program were already in place: a strong health law curriculum; a national ranking; interdisciplinary links across campus to public health, bioethics, and social work via then colleagues eric wright and eric meslin, and our current valued colleague heather mccabe; a strong relationship with our friends at hall render; and, of course, a reputation for excellent health law research and scholarship. these days i would be viewed by health law professors as having been brought up on the wrong side of the tracks. i came from a background of medical malpractice and products liability, with the occasional sprinkling of bioethics and third-party insurance. when i first met eleanor, heard her talk, and read her scholarship, i experienced a very different branch of health law—the doctrine rooted in administrative law and the policy rotating around health care financing. this was the immense contribution eleanor and a small group of like-minded folks brought to the then-fledgling health law academy in the 80s and early 90s. of course, eleanor’s instincts and passions were accurate. today, when i teach my health law and policy course, torts and bioethics issues are shuffled to the last three weeks of the semester, and the vast majority of the course is dominated by the issues eleanor championed—health care financing, public and private health insurance, and inevitably, administrative rule-making. her scholarly output was extraordinary—even in retirement. i counted half a dozen books, twenty-six articles in refereed journals, over fifty articles in law reviews, and another thirty book chapters, book reviews, and so on. i didn’t have the energy to count all her conference presentations. the foundations for this scholarship are not hard to discern; her years at the department of health and human services and, previously named the american hospital association, must have been extraordinary. just imagine being there as healthcare and medicaid started to gain a civil rights lens or being a party to the earliest proposals for major health law reform. even a cursory look at some of the titles of eleanor’s work show the cutting edge, even prescience of her scholarship: hard choices under the medicare prospective payment system from 1986;1 national coverage policy under the * hall render professor of law, executive director, hall center for law and health, indiana university robert h. mckinney school of law. email: npterry@iupui.edu. my thanks to anthony singer, jd/mph candidate for his editorial assistance. 1. eleanor d. kinney, making hard choices under the medicare prospective payment system: one administrative model for allocating medical resources under a government health insurance program, 19 ind. l. rev. 1151 (1986). 8 indiana health law review [vol. 17:7 medicare program: problems and proposals for change from 1988;2 rule and policy-making under the medicaid program: a challenge to federalism in 1990.3 all of these topics could be torn from the headlines on today’s health policy blogs! also, there was her teaching and the tremendous regard in which she was held by her health law students. surely, it’s impossible to overestimate her impact on her students in the early 1980s; a brilliant woman as scholar, teacher, and mentor. those of us in the health academy today should ponder the words of isaac newton in a letter to his robert hooke, in 1676: “what descartes did was a good step. you have added much several ways, and especially in taking the colours of thin plates into philosophical consideration. if i have seen a little further it is by standing on the shoulders of giants.” eleanor was a health law giant. for that i thank her, iu mckinney school of law thanks her, the hall center thanks her, and her countless health law students loudly shout their appreciation! 2. eleanor d. kinney, national coverage policy under the medicare program: problems and proposals for change, 32 st. louis u.l.j. 869 (1988). 3. eleanor d. kinney, rule and policy-making under the medicaid program: a challenge to federalism, 51 ohio st. l.j. 855 (1990). microsoft word final for lulu vol. 14 issue 1 final population health b. growth of programs working towards increased collaboration between public health and law course: seminar in public health law and policy in an interprofessional setting a. research question b. research design. study participants measures a. individual group evaluations b. data collection and analysisx a. interprofessional collaborative competencies attainment survey (“iccas”) 1. theme 1: professional hegemony exists between the professional students 2. theme 2: students perceive professional content expertise as the most important knowledge http://doi.org/10.18060/3911.0030 3. theme 3: learning collaborative skills needs to be intentional and does not occur effectively simply by working together b. challenges to interprofessional collaboration among students keywords a. population health the future of public health core competencies for interprofessional collaborative practice framework for action on interprofessional education & collaborative practice, interprofessional education and teamwork, see also advancing partners and practice through public health supra id. the future of the public’s health in the 21st century, b. growth of programs working towards increased collaboration between public health and law closing the gap in a generation: health equity through action on the social determinants of health , a theory and definition of public health law the strengths model: a recovery-oriented approach to mental health services see also social work expertise: an overlooked opportunity for cutting-edge system design under the patient protection and affordable care act see also https://doi.org/10.1093/bjsw/bcr193 https://doi.org/10.1093/hsw/hlv005 advancing health law & social justice in the clinic, the classroom, and the community figure id. id. teaching law students to practice social justice: an interdisciplinary search for help through social work's empowerment approach. medical-legal partnership logic model medical-legal partnership and healthy start: integrating civil legal aid services into public health advocacy https://doi.org/10.1080/01947648.2014.885333 c. course: seminar in public health law and policy in an interprofessional setting a. research question b. research design c. study participants table 1 interprofessional students groups* d. measures see a. individual group evaluations table 2 individual group evaluation questions b. data collection and analysis validation of the interprofessional collaborative competency attainment survey (“iccas”) id. see critical discourse analysis: an overview supra are we all on the same page? a discourse analysis of interprofessional collaboration, academic medicine, 88 supra table 3. critical discourse analysis building tasks and nodes* a. interprofessional collaborative competencies attainment survey (“iccas”) t p client m sd m sd m sd table 4 iccas subscales pre-test and post-test* see id. 1. theme 1: professional hegemony exists between the professional students 2. theme 2: students perceive professional content expertise as the most important knowledge supra see table 5 course goals and student perspectives* 3. theme 3: learning collaborative skills needs to be intentional and does not occur effectively simply by working together b. challenges to interprofessional collaboration among students supra id. see public health law & equal access to justice in rural america biomarkers for alzheimer’s disease and end-of-life decision-making a fate worse than death? how biomarkers for alzheimer’s disease could affect end-of-life choices rebecca dresser, jd* i. introduction ................................................................. 651 ii. research on ad biomarkers ..................................... 653 iii. potential responses to biomarker test results . 657 a. pre-emptive suicide................................................... 657 b. advance treatment refusals ..................................... 659 c. advance refusals of food and water ........................ 662 d. advance requests for physician-assisted death ..... 665 iv. policy responses ........................................................ 667 i. introduction for many years, scientists have searched for biological markers of the brain deterioration associated with the cognitive impairments characterizing alzheimer’s disease (ad). although the search for useful biomarkers is ongoing, there is increasing evidence that certain brain changes indicate that a person is at relatively high risk of developing full-blown ad. much of the research on ad biomarkers is motivated by the belief that successful treatment will require very early intervention in the disease process. unfortunately, by the time people develop the memory and other behavioral problems that are associated with ad, significant brain damage has already occurred. biomarker tests could give patients and clinicians the opportunity to start drug and other treatments early, with the goal of slowing or stopping the deterioration that can eventually produce the clinical symptoms of ad.1 * daniel noyes kirby professor of law, professor of ethics in medicine, washington university in st. louis. 1 greg miller, stopping alzheimer’s before it starts, 337 science 790 (2012). http://dx.doi.org/10.18060/3911.0004 http://dx.doi.org/10.1126/science.337.6096.790 652 indiana health law review vol. 12:2 we can all hope that the medical promise of ad biomarkers becomes a reality. but it will take years to determine whether biomarker testing and early intervention produce clear health benefits. currently available ad treatments are largely ineffective, and early therapeutic intervention remains unproven. before effective treatment becomes available, many people tested for biomarkers could learn that they are at higher-thanaverage risk of developing ad. some people will appreciate this early warning, for it will give them an opportunity to get their affairs in order, take a long-desired vacation, and “have the kind of heartfelt talks with their children that that people often put off.”2 but for most people, the early warning will be disturbing news. indeed, a few recent surveys suggest that ad is replacing cancer as the most-feared disease among americans.3 as i discuss below, people alarmed at the possibility of losing their mental abilities might act to avoid a future with ad. some people might resort to pre-emptive suicide after receiving their biomarker test results. others might make advance treatment directives refusing all life-sustaining interventions and even ordinary food and water if they become cognitively impaired and unable to make their own medical choices. people living in places that permit physician-assisted suicide and active euthanasia might seek medical assistance in dying, either right away or later, through an advance directive requesting death when they exhibit certain ad symptoms. in short, ad biomarkers create new end-of-life issues for individuals, medical professionals, and policy makers. in part i of this essay, i describe current research findings on ad biomarkers and their implications for end-of-life 2 id. at 792. 3 see, e.g., help for alzheimer’s families, americans rank alzheimer’s as most feared disease (nov. 13, 2012), http://www.helpforalzheimersfamilies.com/alzheimers-dementia-careservices/alzheimers_feared_disease/; mario garrett, fear of dementia (may 11, 2013), http://www.psychologytoday.com/blog/iage/201305/feardementia. 2015 a fate worse than death? 653 practices. part ii considers potential end-of-life responses to biomarker test findings and examines ethical and legal issues raised by those responses. part iii concludes with recommendations for clinicians and policy makers addressing the potential end-of-life impact of biomarker test findings. ii. research on ad biomarkers scientists have not yet definitively established the causes of ad. most experts trace the condition to a peptide called beta-amyloid and a protein called tau. the brains of people with symptomatic ad have pathological changes called “senile plaques,” which are linked to beta-amyloid, and “neurofibrillary tangles,” which are linked to tau.4 one major biomarker test involves measuring beta-amyloid and tau levels in a person’s spinal fluid.5 the other major test uses magnetic resonance and positron emission tomography (pet) imaging to assess structural changes and the presence of beta-amyloid in the brain.6 4 bruno dubois et al., revising the definition of alzheimer’s disease: a new lexicon, 9 lancet neurology 1118, 1119 (2010). alzheimer’s disease is a subset of the broader disease category called dementia. the biomarker tests i describe in this article apply to ad alone, not to all forms of dementia. 5 stephanie vos et al., preclinical alzheimer’s disease and its outcome: a longitudinal cohort study, 12 lancet neurology 957 (2013). 6 rahul desikan et al., an expanded role for neuroimaging in the evaluation of memory impairment, 34 am. j. neuroradiology 2075 (2013). more ad biomarker tests will probably be developed in the future. a research group recently published study results showing that a blood test could predict onset of mild cognitive impairment or alzheimer’s disease with ninety percent accuracy. the study followed 525 cognitively normal adults aged seventy and older for five years. mark mapstone et al., plasma phospholipids identify antecedent memory impairment in older adults, 20 nature medicine 415 (2014). as the researchers noted, however, the blood test will require additional evaluation before experts can determine whether it is sufficiently accurate for clinical use. id. at 418. because such a test would probably be relatively inexpensive and simple to perform, it could make biomarker test results widely available to healthy older people interested in determining their ad risk. see dena davis, a blood test http://dx.doi.org/10.1016/s1474-4422(10)70223-4 http://dx.doi.org/10.1016/s1474-4422(13)70194-7 http://dx.doi.org/10.3174/ajnr.a3644 http://dx.doi.org/10.1038/nm.3466 654 indiana health law review vol. 12:2 scientists currently “lack … a clear understanding of the relation between the neuropathological pattern of [alzheimer’s] disease and its clinical occurrence.”7 although most experts believe that the plaques and tangles associated with beta-amyloid and tau underlie ad symptoms, autopsies of cognitively normal older people reveal that many have plaques and tangles in their brains.8 this means that they either die of other causes before the brain pathology produces symptoms, or that other protective factors involving genes, environmental conditions, or brain or cognitive “reserve” prevent the brain pathology from affecting their thinking.9 the ongoing evaluation of ad research findings has generated new diagnostic classifications. many experts use a classification called mild cognitive impairment to refer to people who have episodic memory impairment, but not the more severe deficits required for a diagnosis of ad.10 a second classification, preclinical ad, covers people who have a positive biomarker test but no detected memory impairment.11 a third diagnostic classification, sometimes called “prodromal ad” covers people who have both episodic memory impairment and a positive biomarker test.12 these to predict alzheimer’s disease: what’s the elephant in the room? bioethics forum (apr. 7, 2014), http://thehastingscenter.org/bioethicsforum/post.aspx?id=6858&blogid= 140. 7 dubois et al., supra note 4, at 1121. 8 lon schneider, organising the language of alzheimer’s disease in light of biomarkers, 9 lancet neurology 1044 (2010). 9 reisa sperling et al., toward defining the preclinical stages of alzheimer’s disease: recommendations from the national institute on aging-alzheimer’s association workgroups on diagnostic guidelines for alzheimer’s disease, 7 alzheimer’s & dementia 280, 287 (2011). see also kenneth covinsky, caution on diagnosing preclinical alzheimer’s disease (july 15, 2011), bioethics forum, http://www.thehastingscenter.org/bioethicsforum/post.aspx?id=5454&bl ogid=140 (noting that “autopsy finding[s] suggestive of alzheimer’s disease are commonly found in people who never had symptoms”). 10 sperling et al., supra note 9, at 281. 11 schneider, supra note 8, at 1044. 12 see dubois et al., supra note 4, at 1122-23; schneider, supra note 8, at 1044. the term “prodromal” means a precursor indicating the onset of a disease process. http://dx.doi.org/10.1016/s1474-4422(10)70246-5 http://dx.doi.org/10.1016/j.jalz.2011.03.003 2015 a fate worse than death? 655 three labels are applied to people who could eventually develop ad symptoms, but could also live for many years and perhaps the rest of their lives without doing so. a study published in 2013 illustrates the situation.13 in this study, researchers evaluated 311 study participants sixty-five years or older over a five-year period. eleven percent of the participants who scored within the normal range on cognitive testing, but had abnormal levels of betaamyloid, developed measurable cognitive decline five years after the test. twenty-six percent of the participants with normal cognitive function, but abnormal levels of both betaamyloid and tau, showed some mental decline during the five-year period. these progression rates were much higher than the progression rates of participants in the control group, who were cognitively normal people with normal amyloid and tau levels. just two percent of the participants in that group showed some mental decline after five years.14 although study participants with positive biomarker tests and normal cognitive test scores were found to be at higher risk of developing ad, most of these participants scored within the normal range on cognitive assessments five years after biomarker testing. the results were markedly different for study participants who initially had both abnormal beta-amyloid and tau levels and subtle mental decline. after five years, fifty-six percent of participants in that group received cognitive test scores consistent with ad.15 although the expert community is divided, there is increasing support for the use of biomarkers as a diagnostic aid when people are also exhibiting the cognitive symptoms characterizing ad.16 but many experts believe that because 13 vos et al., supra note 5. 14 id. at 960. 15 id. 16 see, e.g., keith johnson et al., appropriate use criteria for amyloid pet: a report of the amyloid imaging task force, the society of nuclear medicine and molecular imaging, and the alzheimer’s association, 9 alzheimer’s & dementia e1-e16 (2013). but lack of insurance coverage for such testing has so far limited its use. see judith graham, debate over brain scans and alzheimer’s, n.y. times (feb. 12, 2013), http://newoldage.blogs.nytimes.com/2013/02/12/debatehttp://dx.doi.org/10.1016/j.jalz.2013.01.002 656 indiana health law review vol. 12:2 biomarker tests for presymptomatic ad remain unproven, they should be performed only in a research context.17 at the same time, many cognitively normal and mildly impaired research participants, joined by individuals who are not participating in research, say they want access to the results of their biomarker tests.18 and a 2013 survey suggests that researchers may be moving to support return of test results to participants in ad biomarker research.19 despite current uncertainty about the value of biomarker test results, more people are likely to learn their results in the coming years. some researchers and physicians are likely to accede to research participants’ and patients’ requests to provide biomarker test results. individuals obtaining their test results will receive probabilistic information. although biomarker test results can indicate that a person is at relatively high risk of developing ad, people diagnosed with preclinical ad, mild cognitive impairment, and prodromal ad may never over-brain-scans-and-alzheimers (reporting on medicare decision declining to cover brain scans for diagnostic purposes, based on lack of evidence showing adequate health benefit). medicare will cover one scan for individuals participating in clinical studies, however. center for medicare services, decision memo for beta amyloid positron emission tomography in dementia and neurodegenerative disease (cag-00431n) (sept. 27, 2013), available at http://www.cms.gov/ medicare-coverage-database/details/nca-decisionmemo.aspx?ncaid=265. 17 e.g., albert et al., the diagnosis of mild cognitive impairment due to alzheimer’s disease: recommendations from the national institute on aging-alzheimer’s association workgroups on diagnostic guidelines for alzheimer’s disease, 7 alzheimer’s & dementia 270, 271 (2011); guy mckhann, changing concepts of alzheimer disease, 305 jama 2458, 2459 (2011). 18 see j. scott roberts et al., amyloid imaging, risk disclosure, and alzheimer’s disease, 3 neurodegenerative disease mgmt. 219, 223 (2013); melanie shulman et al., using ad biomarker research results for clinical care: a survey of adni investigators, 81 neurology1114 (2013); susan gilbert, support for returning results of alzheimer’s disease biomarker research, bioethics forum (aug. 28, 2013), http://thehastingscenter.org/bioethicsforum/post.aspx?id=6487&amp;bl ogid=140&terms=biomarker+and+%23filename+*.html. 19 shulman et al., supra note 18. http://dx.doi.org/10.1016/j.jalz.2011.03.008 http://dx.doi.org/10.1001/jama.2011.810 http://dx.doi.org/10.2217/nmt.13.25 http://dx.doi.org/10.1212/wnl.0b013e3182a55f4a 2015 a fate worse than death? 657 develop the symptoms they fear. i turn now to the impact that ad biomarkers could have on end-of-life choices. iii. potential responses to biomarker test results a. pre-emptive suicide pre-emptive suicide is one potential response to biomarker test results suggesting a high relative risk of ad.20 in a 2014 journal of medical ethics article, bioethicist dena davis described and defended such a response.21 she gave several reasons why someone might prefer suicide over a probable future with ad. people might want their assets to go to relatives or charitable organizations, rather than to the workers and facilities that provide dementia care. people might also want to protect their loved ones from the burdens that ad can impose on others.22 people who see life with mental impairment as a “loss of self”23 and an affront to their dignity may prefer death in the near future over longer survival with the prospect of ad.24 davis also pointed out that unlike people diagnosed with other serious diseases like cancer or hiv, people with positive ad biomarker tests cannot postpone suicide until they actually experience unwanted symptoms. suicide 20 see richard caselli et al., public perceptions of presymptomatic testing for alzheimer disease, mayo clin. proceedings (2014), http://dx.doi.org/10.1016/j.mayocp.2014.05.016 (in online survey of people interested in ad research, 10.2 percent would seriously consider suicide if had biomarker evidence of ad). see also brian draper et al., early dementia diagnosis and risk of suicide and euthanasia, 6 alzheimer’s & dementia 75 (2010) (discussing suicide possibility). 21 dena davis, alzheimer disease and pre-emptive suicide, 40 j. med. ethics 543 (2014). 22 of course, a person’s decision to commit pre-emptive suicide could impose burdens on families, too. 23 stephen post, physician-assisted suicide in alzheimer’s disease, 45 j. am. geriatrics soc’y 647 (1997). 24 indeed, one philosopher has argued that the “soon-to-be demented” have a duty to commit suicide before losing their dignity as moral agents. dennis cooley, a kantian moral duty for the soon-to-bedemented to commit suicide, 7 am. j. bioethics 37 (2007). http://dx.doi.org/10.1016/j.mayocp.2014.05.016 http://dx.doi.org/10.1016/j.jalz.2009.04.1229 http://dx.doi.org/10.1136/medethics-2012-101022 http://dx.doi.org/10.1111/j.1532-5415.1997.tb03106.x http://dx.doi.org/10.1080/15265160701347478 658 indiana health law review vol. 12:2 takes relatively sophisticated planning, as well as a strong commitment. by the time ad symptoms develop, people are often unable to carry out a successful suicide; they may also lose interest in doing so.25 davis observed that biomarker testing could enable more people to commit suicide before ad deprives them of the opportunity. in a commentary on davis’s paper,26 i noted that currently available tests cannot give people definitive information about their futures. as i said earlier, many people with positive biomarker tests fail to progress to symptomatic ad. will people be willing to end their lives based on an eleven percent or twenty-six percent possibility of ad in five years? moreover, by the time people experience even mild mental decline (when the odds of progressing to ad become greater), they may no longer have the mental ability or the motivation to commit suicide. and even people who are able and willing to end their lives may have second thoughts about the wisdom of pre-emptive suicide once the choice becomes a real one. at that point, a life facing potential ad may seem to them preferable to no life at all.27 25 see peter rabins, can suicide be a rational and ethical act in persons with early or pre-dementia? 7 am. j. bioethics 47 (2007) (noting that lack of distress may be related to person’s mental condition). 26 rebecca dresser, pre-emptive suicide, precedent autonomy and preclinical alzheimer disease, 40 j. med. ethics 550 (2014). 27 people with life-threatening conditions are known to reevaluate their judgments about what constitutes a life worth living as their conditions advance, becoming more accepting of situations they previously thought would be unacceptable. people change their minds over time “because they cannot accurately imagine what they will want and how much they can endure in a condition they have not experienced.” jerome groopman & pamela hartzband, advance directives are the beginning of care, not the end, acp internist (july/aug., 2012), available at http://www.acpinternist.org/archives/2012/07/gray.htm, archived at http://perma.cc/4v7f-nunn. see also sara goering, what makes suffering “unbearable and hopeless”? advance directives, dementia, and disability, 7 am. j. bioethics 62 (2007) (noting that “our anticipatory beliefs fail to recognize our ability to adapt as well as how much the circumstances of impairment affect our ability to flourish”). http://dx.doi.org/10.1080/15265160701347494 http://dx.doi.org/10.1136/medethics-2013-101615 http://dx.doi.org/10.1080/15265160701221145 2015 a fate worse than death? 659 nevertheless, i agree with davis’s claim that biomarker tests could lead some people to commit suicide to avoid a future with ad. there is some evidence suggesting that receiving an actual ad diagnosis raises the risk of suicide, although it appears that many of those suicides occur in people who are also clinically depressed.28 in my view, legal measures to completely prevent pre-emptive suicide would be morally unjustified, as well as impractical. such measures would involve unacceptable and unworkable deprivations of liberty, such as confinement or continuous monitoring of individuals at risk for ad. at the same time, however, certain policy measures could discourage impulsive and uninformed suicide attempts based on ad biomarker results. in the concluding part of this essay, i describe such measures. b. advance treatment refusals advance treatment directives refusing all life-sustaining interventions are another potential response to ad biomarker testing. through an advance directive, mentally competent individuals can make choices about the future treatment they want to receive as incompetent patients. they can, for example, give instructions that they should not receive any treatment for life-threatening medical conditions if they develop ad and can no longer make contemporaneous treatment decisions. positive biomarker test results could provoke some people to make advance directives refusing any treatment that could extend their lives with ad. since the 1990s, there has been a lively discussion about the ethical issues raised by this kind of advance directive. according to some scholars, such as ronald dworkin, directives like this should be followed, even if they conflict with a patient’s contemporaneous best interests.29 dworkin argued that the competent person’s values and preferences have greater 28 see draper et al., supra note 20, at 79-80 for a review of the literature. 29 ronald dworkin, life’s dominion: an argument about abortion, euthanasia, and individual freedom 231 (1993). 660 indiana health law review vol. 12:2 moral weight than do the welfare interests of a mentally incapacitated individual.30 thus, he wrote, the law should permit people “who are repelled by the idea of living demented, totally dependent lives, speaking gibberish” to direct that “if they become permanently and seriously demented and then develop a serious illness, they should not be given medical treatment except to avoid pain.”31 in defending this view, dworkin gave an example of a case in which such a directive should be followed. the case involved a patient named margo. margo had been the subject of an article by a medical student, andrew firlik, who had come to know margo in the course of his training.32 margo appeared to enjoy music and art therapy classes; she also seemed pleased when firlik visited, although she never called him by name. although she had lost much of her memory and needed assistance with many activities, firlik concluded that margo was “undeniably one of the happiest people i have known.”33 dworkin asked readers to imagine that margo had previously prepared an advance directive stating that if she developed ad, “she should not receive treatment for any other serious life-threatening disease she might contract.”34 that directive should govern margo’s care, dworkin declared, even if she was currently living a life that gave her satisfaction and pleasure.35 her wishes as a competent person should take priority over her current interests as an incompetent dementia patient, he argued.36 in contrast, a second group of scholars supports limiting the power that advance directives have over ad patient 30 id. 31 id. the quotation suggests that pain avoidance was the one welfare interest of dementia patients that dworkin believed should be protected. for analyses similar to dworkin’s, see dena davis, supra note 21; norman cantor, prospective autonomy: on the limits of shaping one’s postcompetence medical fate, 8 j. contemp. health l. & pol’y 13 (1992). 32 andrew firlik, margo’s logo, 265 j. am. med. ass’n 201 (1991). 33 id. 34 dworkin, supra note 29, at 226. 35 id. 36 id. http://dx.doi.org/10.1001/jama.1991.03460020055013 2015 a fate worse than death? 661 care. this group acknowledges that advance directives can be useful in addressing treatment questions, for directives often refuse treatment that would not serve the patient’s current welfare interests. for example, advance directives refusing burdensome interventions like chemotherapy and surgery often promote an ad patient’s welfare, because such interventions impose pain and distress on a person who cannot understand or remember why they are being done. but sometimes a minimally burdensome treatment, such as an oral antibiotic, can allow an ad patient like margo to continue a life of apparent contentment. such patients no longer remember the values that led them to refuse treatment in this situation, and they remain able to engage in activities and interactions that they enjoy.37 i and others are unconvinced that an individual’s former wish to avoid such a state should always take priority over her current interests in continuing a life that she appears to value.38 in other contexts, law and policy recognize that people with mental disabilities can have lives of meaning and worth. the legal and ethical question is whether the rules governing advance directives should incorporate, or reject, this moral judgment. should competent people have absolute authority over the future care they receive as ad 37 philosopher agnieszka jaworska developed the concept of “capacity to value” to describe some ad patients’ retention of a basic capacity for autonomy. jaworska believes that such patients’ contemporaneous preferences and interests are a form of autonomy that deserves respect. see agnieszka jaworska, respecting the margins of agency: alzheimer’s patients and the capacity to value, 28 phil. & pub. aff. 105 (1999). 38 see rebecca dresser, dworkin on dementia: elegant theory, questionable policy, 25 hastings center rep. 32 (nov.-dec. 1992). for other accounts defending limits on advance directives in cases involving some conscious ad patients, see jaworska, supra note 37; allen buchanan, advance directives and the personal identity problem, 17 phil. & pub. aff. 277 (1988). for a middle-ground position, see paul menzel & bonnie steinbock, advance directives, dementia, and physician-assisted death, 41 j. l. med. ethics 484, at 498 (arguing for similar judgments regarding advance directives for physician-assisted death and refusal of life-sustaining treatment in dementia). http://dx.doi.org/10.1111/j.1088-4963.1999.00105.x http://dx.doi.org/10.1111/jlme.12057 662 indiana health law review vol. 12:2 patients, or should legal rules and professional standards set limits on that authority? to date, courts and other authorities have not directly addressed the issue i have described. relatively few people make advance treatment directives containing precise instructions for future treatment, and i have not heard or read about an actual directive like the one dworkin described.39 a few courts have mandated medical nutrition and hydration for conscious incapacitated patients who previously made informal remarks suggesting that they would oppose such treatment. but none of these cases involved a formal advance directive refusing all lifesustaining measures as an incapacitated patient.40 in the coming years, clinicians and courts are likely to encounter advance directives presenting conflicts between a dementia patient’s past wishes and current interests. the baby boom generation is aging, and many in this group are both insistent on controlling their future medical care and terrified by the prospect of dementia. the results of ad biomarker tests could lead some of them to make a directive like the one dworkin envisioned. c. advance refusals of food and water people disturbed by their ad biomarker test results might also look to a new form of advance directive to avoid life with dementia. in a recent article, paul menzel and collette chandler-cramer argue that clinicians and legal authorities should recognize advance refusals of not only life-prolonging medical interventions, but also of spoonfeeding and other assistance with ordinary eating and 39 see generally muriel gillick, reversing the code status of advance directives? 362 new engl. j. med. 1239 (2010) (reviewing shortcomings of advance directives and suggesting reforms). 40 see rebecca dresser, the conscious incompetent patient, 32 hastings cent. rep. 9 (may-june 2002); rebecca dresser, still troubled: in re martin, 26 hastings cent. rep. 21 (july-aug. 1996) (describing two representative cases). http://dx.doi.org/10.1056/nejme1000136 2015 a fate worse than death? 663 drinking.41 this advance directive would be a valuable tool for individuals seeking to avoid a lingering death with dementia, they say. the directive menzel and chandler-cramer propose would apply only to patients in the late stages of ad, when patients require assistance with nearly every activity, including eating and drinking. these authors see advanced dementia as the final stage of life. by the time patients become “indifferent” to food, they are unable to walk, converse, or recognize their loved ones. at that point, menzel and chandler-cramer contend, the patients’ interests in survival are small enough that the decision to withhold food and water fails to present a threat to their welfare. menzel and chandler-cramer offer several justifications for their proposal. besides arguing that the law should respect the competent individual’s interest in controlling future care, they describe evidence indicating that death due to lack of nutrition and hydration is relatively comfortable. the law permits competent patients to hasten death by refusing to eat and drink, they observe, so why not allow people to do so in advance? i agree that such a directive would be appealing to people intent on avoiding the lengthy decline and severe incapacities that characterize late-stage dementia. but in a commentary on the proposal, i raised questions about its legality.42 although the law permits competent patients to refuse ordinary food and water, no statute or court decision recognizes the competent person’s right to make an advance directive refusing assistance with eating and drinking.43 imposing tube feeding on an objecting competent patient is a clear and massive intrusion on that person’s liberty and bodily integrity. in contrast, giving a dementia patient help 41 paul menzel & colette chandler-cramer, advance directives, dementia, and withholding food and water by mouth, 44 hastings center rep. 23 (may-june 2014). 42 rebecca dresser, toward a humane death with dementia, 44 hastings center rep. 38 (may-june 2014). 43 see thaddeus pope & amanda west, legal briefing: voluntarily stopping eating and drinking, 25 j. clin. ethics 68 (2014). 664 indiana health law review vol. 12:2 with ordinary eating and drinking fails to constitute such a serious intrusion, even if the individual previously refused such help. it is not clear that legal authorities will equate advance refusals of assistance with eating and drinking with competent patients’ contemporaneous refusals of food and water. the proposal also raises ethical concerns, for it could compromise the welfare of some dementia patients. menzel and chandler-cramer describe a patient named shari as one candidate for their approach. before she was diagnosed with ad, shari made an advance directive refusing assisted feeding as an advanced ad patient. shari now has advanced ad, is incontinent, and cannot “walk, feed herself, or chew and swallow.”44 with spoon-feeding and encouragement, however, she swallows nutritional smoothies. and shari “occasionally appears to get pleasure from the smoothies and she seldom expresses distress or discomfort.”45 despite that fact that shari accepts nourishment, menzel and chandler-cramer believe that nourishment should be withheld based on her advance directive. my concern is that a patient like shari could experience distress and discomfort if no one offers her the smoothies she is accustomed to receiving. shari is not an ad patient who resists eating or experiences choking or other distressing effects when she tries to swallow. withholding food and water from such a patient is defensible on grounds that it maintains the patient’s comfort. but that defense doesn’t apply in cases like shari’s. before allowing withholding in such cases, it will be necessary to examine the burdens withholding could impose on a patient like shari. despite these concerns, people with positive ad biomarker test results could advocate for the right to make directives like the one menzel and chandler-cramer propose. with the availability of biomarker test results, clinicians and policy makers could face increased pressure to permit and enforce such directives. 44 menzel & chandler-cramer, supra note 41, at 23. 45 id. 2015 a fate worse than death? 665 d. advance requests for physician-assisted death requests for physician-assisted death are an additional potential response to ad biomarker testing. legal authorities in the united states have not recognized a right to medically assisted death for anyone at risk of or diagnosed with ad. a few states have legalized physicianassisted suicide, but only for terminally ill competent patients with six months or less to live.46 it is a different story in the netherlands, however. that nation has a liberal law governing access to medically assisted death, one that permits physician-assisted suicide and active euthanasia in a wide range of situations. two requirements in the dutch law would appear to disqualify ad patients from eligibility for assisted death. the law permits physicians to respond only to requests that are “voluntary and well considered” made by people experiencing “the situation as ‘unbearable’ and one of ‘hopeless suffering.’”47 studies have found that most dutch physicians are unwilling to follow advance directives requesting euthanasia for ad, citing “difficulty determining the suffering of the patient and determining the exact moment” to carry out the advance directive.48 coping mechanisms lead many early ad patients to downplay the problems they are experiencing, and as the disease progresses, people become completely unaware of those problems. as one group of dutch clinicians put it, in the typical patient, “the realization of having dementia is 46 see erik eckholm, ‘aid in dying’ movement takes hold in some states, n.y times, feb. 7, 2014, http://www.nytimes.com/2014 /02/08/us/easing-terminal-patients-path-to-death-legally.html#. 47 see cees m. p. m. hertogh et al., would we rather lose our life than lose our self? lessons from the dutch debate on euthanasia for patients with dementia, 7 am. j. bioethics 48, 49 (2007) (describing dutch law). 48 see id. at 50-51; marike e. de boer et al., advance directives for euthanasia in dementia: do law-based opportunities lead to more euthanasia? 98 health pol’y 256, 260-61 (2010). see also ron l. p. berghmans, ethics of end-of-life decisions in cases of dementia: views of the royal dutch medical association with some critical comments, 13 alzheimer’s disease & associated disorders 91 (1999) (discussing these problems). http://dx.doi.org/10.1080/15265160701220881 http://dx.doi.org/10.1016/j.healthpol.2010.06.024 http://dx.doi.org/10.1097/00002093-199904000-00006 666 indiana health law review vol. 12:2 progressively lacking from the patient’s subjective experience and hence it is impossible for someone in an advanced stage of dementia to appreciate the situation as ‘unbearable and hopeless.’”49 nevertheless, dutch physicians have performed euthanasia for people in the early stages of ad.50 and in 2011, a woman with advanced ad was euthanized based on a request contained in her advance directive, a directive that was made five years after her ad diagnosis.51 officials approved euthanasia in these cases, despite doubts about the decision-making capacity of the ad patients and questions about whether the patients were actually experiencing unbearable suffering.52 in light of this nation’s conservative position on assisted death, u.s. clinicians and officials are unlikely to face these issues in the near future. but given the “alzheimerphobia”53 that also exists in this country, u.s. clinicians and officials may eventually confront demands to allow medically assisted death for people with early-stage ad, as well as for people in later stages of the disease based on their requests contained in advance directives.54 the 49 hertogh et al., supra note 43, at 51. 50 see tony sheldon, dementia patient’s suicide was lawful, say dutch authorities, 343 bmj d7510 (2011) [hereinafter sheldon, dementia patient’s suicide]; tony sheldon, dutch committee approves euthanasia for a patient with alzheimer’s disease, 330 bmj 1041 (2005) [hereinafter sheldon, dutch committee]. 51 see dementia patient’s suicide, supra note 51. 52 see assisted dying in alzheimer’s disease: the dutch experience, 4 lancet neurology 389, 389 (2005) (raising these questions). 53 draper et al., supra note 20, at 76. 54 see, e.g., menzel & steinbock, supra note 38, at 484; janice schuster, invitation to a dialogue: legalizing aid in dying, n.y. times, mar. 25, 2013, http://www.nytimes.com/2013/03/27/opinion/invitation-toa-dialogue-legalizing-aid-in-dying.html (discussing possibility of assisted death for dementia patients). janet adkins, the first person committing suicide with the assistance of michigan doctor jack kevorkian, had been recently diagnosed with ad. see timothy egan, as memory and music faded, oregon woman chose death, n.y. times, june 7, 1990, http://www.nytimes.com/1990/06/07/us/as-memory-andmusic-faded-oregon-woman-chose-death.html. http://dx.doi.org/10.1136/bmj.d7510 http://dx.doi.org/10.1136/bmj.330.7499.1041-a http://dx.doi.org/10.1016/s1474-4422(05)70101-0 2015 a fate worse than death? 667 availability of ad biomarker tests could increase public support for such measures. iv. policy responses as i noted earlier, researchers and clinicians have in the past failed to disclose biomarker test results to research participants and patients, citing the uncertain meaning of the results. but this approach is under attack by people who have had or are interested in having the tests, and by health professionals who believe that test results are sufficiently informative to support disclosure. researchers and clinicians are becoming more open to disclosing results to people who want to know their ad biomarker status.55 the next step is for researchers, clinicians, and policy makers to develop an adequate approach to disclosure of biomarker test results. potential recipients of test results must understand the risks and burdens, anticipated benefits, and alternatives to biomarker testing.56 they must understand, for example, the risk that a positive biomarker test result in their medical record would expose them to workplace or insurance discrimination.57 two features of biomarker test results are particularly important, yet challenging, to address in the disclosure process. health professionals must teach people about the limited predictive power of biomarker test results, and about the significant possibility that people with positive test results will not progress to ad for a many years, if ever.58 this education is necessary to prevent people from making uninformed end-of-life decisions based on their test results. health professionals must also address the fears people have about ad. one expert group has commented that “the lived experience of dementia differs from the imagined 55 see infra pp. 5-6. 56 see draper et al., supra note 20, at 81; jason karlawish, addressing the ethical, policy, and social challenge of preclinical alzheimer disease, 77 neurology 1487, 1489 (2011). 57 see roberts, supra note 18, at 224. 58 id. http://dx.doi.org/10.1212/wnl.0b013e318232ac1a 668 indiana health law review vol. 12:2 experience.”59 according to another expert who has worked with ad patients for thirty years, people who say they would not want to live with dementia are “overestimating the importance of cognition in their lives and underestimating the importance of interpersonal relationships.”60 other experts have made similar observations, 61 with some noting that patients’ families are often more distressed than are the patients themselves.62 indeed, empirical evidence suggests that many people with ad report and appear to have a good quality of life.63 as a group of dutch researchers noted, “[f]urther exploration of the lived experience of dementia is urgently needed to counterbalance the natural, but nonetheless one-sided ideas of elderly people who are scared of dementia.”64 at the same time, depression and anxiety are not uncommon among people with ad.65 although certain ad patients don’t appear to have a good quality of life, their burdens can be lessened when they receive care that is tailored to their needs. british psychologist tom kitwood pioneered a person-centered approach to dementia care that is now being adopted in some dementia care settings.66 the 59 draper et al., supra note 20, at 77. 60 rabins, supra note 25, at 49. 61 see, e.g., alan jacques & graham jackson, understanding dementia 197-99 (3d ed. 2000) (patients unlikely to be aware of changes in their abilities or humiliated by their dependence). 62 see, e.g., diane meier & christine cassel, nursing home placement and the demented patient, 104 annals internal med. 98, 102 (noting that families’ distress can often exceed that of patients; patients “can appear to be at peace and secure in a safe familiar environment”). 63 see draper et al., supra note 20, at 77 (summarizing findings on ad patients’ quality of life). see also goering, supra note 27, at 62 (noting that stigma and fear can distort views of what life with dementia and disability is really like). 64 hertogh et al., supra note 47, at 54. 65 see draper et al., supra note 20, at 77. 66 see, e.g., tom kitwood & kathleen bredin, towards a theory of dementia care: personhood and well-being, 12 ageing & society 269 (1992). see also steven sabat, voices of alzheimer’s disease sufferers: a call for treatment based on personhood, 9 j. clinical ethics 35 (1998) (presenting similar view). for a description of how the approach http://dx.doi.org/10.7326/0003-4819-104-1-98 http://dx.doi.org/10.1017/s0144686x0000502x 2015 a fate worse than death? 669 approach asks others to value what people with dementia are able to do, such as live in the moment and respond to others with an honesty unseen among cognitively “normal” people.67 by trying to see the world through the eyes of a person with ad, caregivers seek to provide an environment that is pleasant and comfortable for that person.68 people with positive biomarker tests need an accurate picture of what life with ad involves before they make endof-life choices based on their test results. although ad is a frightening prospect, some of that fear is based on a lack of understanding of what life can be like for people with ad. implementing kitwood’s patient-centered care approach is part of a broader national and worldwide task: to respond to the growing population of people affected by ad and other forms of dementia. this demographic development presents immense ethical, medical, financial, legal, and social challenges, in this country and the rest of the world.69 determining the proper role of ad biomarkers in end-of-life choices will be one of these challenges. works in practice, see rebecca mead, the sense of an ending, new yorker, may 20, 2013. 67 see nuffield council on bioethics, dementia: ethical issues (2009), http://nuffieldbioethics.org/dementia (describing community’s ethical obligation to accept people with dementia and provide services adapted to their needs). see also sarah walker-robinson, let’s talk (some more) about dementia, june 17, 2014, http://blog.nuffieldbioethics.org/?p=1279 (describing efforts to make society more “dementia-friendly”). 68 see jacques & jackson, supra note 61, at 200-01; mead, supra note 66. 69 see michael hurd et al., monetary costs of dementia in the united states, 368 new eng. j med. 1326 (2013); thomas montine & eric larson, late-life dementias: does this unyielding global challenge require a broader view? 302 j. am. med. ass’n 2539 (2009). http://dx.doi.org/10.1056/nejmc1305541 http://dx.doi.org/10.1001/jama.2009.1863 i. introduction ii. research on ad biomarkers iii. potential responses to biomarker test results a. pre-emptive suicide b. advance treatment refusals c. advance refusals of food and water d. advance requests for physician-assisted death iv. policy responses neal f. eggeson, jr. neal f. eggeson earned his b.a. from butler university in 1995, graduat­ ing cum laude with high departmental honors after only six semesters. thereafter, mr. eggeson earned his j.d. from cornell university where he served on the cornell international law review, won the 1998 cornell moot court winter cup, earned the ralston r. irvine award for legal writ­ ing, and pursued additional graduate studies in philosophy. since returning to indiana, mr. eggeson has focused exclusively on civil jury trial and appellate practice. after devoting many years to insurance defense litigation, mr. ~ggeson opened his own law frrm which provides legal research and writing services to attorneys throughout the state. mr. eggeson's writings on negligence law have appeared in the indiana law encyclopedia, the indiana lawyer, and res gestae, and he is the 2006 run­ ner-up for the harrison legal writing award from the indiana state bar association. mr. eggeson has argued and/or briefed appeals in the indiana supreme court, the indiana court of appeals, the sixth and seventh circuit courts of appeals, and the united states supreme court. mr. eggeson has earned the designation of "master advocate" from the national institute of trial advocacy, and he is a member of mensa. in his free time, mr. eggeson volunteers with the hamilton county guardi­ an ad litem program, and he teaches legal analysis, research & commu­ nication as an adjunct clinical professor of law at the indiana university school of law indianapolis. snatching confusion from the jaws of clarity: the puzzling evolution of the discovery rule vis-a-vis indiana's medical malpractice statute of limitations neal f. eggeson, jr.' i. introduction ................................................................................. 98 ii. the medical malpractice statute of limitations and the development of the discovery rule .............................. 100 a. the origins of the medical malpractice statute of limitations ............................................................................... 100 b. creation of the discovery rule ................................................ 102 1. does the "discovery of malpractice" rule apply only to medical conditions with long latency periods? ........... 104 2. what types of facts will satisfy the standard? .................. i05 3. what does "reasonable diligence" mean? ...................... 106 4. when is the trigger date determination a question of fact, and when is it a question of law? ....................... 106 5. who resolves the questions of factthe court or the jury? ............................................................................. 107 c. developing the standard (1999-2005) ..................................... 107 d. the supreme court re-enters the fray (2005) ........................ 112 e. the 2008 trio of supreme court decisions ............................. 115 1. brinkman v. bueter ............................................................. 115 2. overton v. grillo ................................................................. 117 3. herron v. anigbo ................................................................ 120 ill. synthesis: the state of the law as of 2008 ......................... 122 a. the objective standard remains unchanged ......................... 122 b. questions of fact vs. questions oflaw ................................... 123 c. how the discovery date affects the limitations period ......... 124 d. analysis not limited to conditions with long latency periods ..................................................................................... 125 e. lay suspicion is irrelevant ...................................................... 126 f. worsening symptoms vs. physician notification of probable malpractice .............................................................. 127 g. discovery of injury and receipt of correct diagnosis insufficient (usually) ............................................................... 128 h. fraudulent concealment remains a viable, yet impotent, doctrine ................................................................................... 129 * neal f. eggeson, jr. (j.d., cornell law school 1998; b.a., butler university 1995) is a clinical adjunct professor law at the indiana university school of lawindian­ apolis, where he has taught legal analysis, research & communication from 2006-2010. 98 indiana health law review [vol. 8:95 i. "reasonable diligence" requires investigation, not complete inactivity .................................................................... 131 iv. the indiana court of appeals careens off the tracks •... 132 a. the facts .................................................................................. 132 b. the court's analysis ................................................................ 134 c. dissecting the court's rationale ............................................. 135 1. rationale #1: non-latency ................................................. 135 2. rationale #2: correct diagnosis ........................................ 136 3. rationale #3: worsening symptoms ................................... 136 4. rationale #4: lay suspicion ............................................... 137 v. conclusion .•..........•....••..•••••..•••...••....•••.•••••..•••..•.••...•••.....•.•........ 140 abstract for medical malpractice actions in indiana, a frequently contradictory and always-confusing pool of jurisprudence has swelled around the statute of limitations. with its announcement of an accrual-based standard in 1999, the indiana supreme court imposed a seemingly-impossible chal­ lenge on indiana patients, attorneys, and judges: divine the factor(s) are­ viewing court will deem sufficient to trigger the statute of limitations in a given medical malpractice case. for some litigants, this confounding exer­ cise means filing a lawsuit solely to protect the statute of limitations even before the patient or her attorney knows that a claim exists, leaving the liti­ gant to hope that her suspicions of negligence will find support in the evi­ dence. for the more dutiful litigant, any investigation designed to detect or confirm negligence risks a post hoc evaluation of past symptoms, test re­ sults, conversations, or diagnoses which, in retrospect, should have led to the discovery of the malpractice. and each time an indiana court dares at­ tempt to create unity out of the impossibly-inconsistent precedent that came before, a subsequent court tears down the transitory edifice of consensus as quickly as it had been built. this frustrating pattern culminated in late 2009 when the indiana court of appeals forced medical malpractice litigants back to square one on nearly every principle of discovery rule jurisprudence established over the prior decade. this article tracks the common law evo­ lution of the discovery rule in indiana's medical malpractice jurisprudence, synthesizes the common law history into a workable framework for future applications of the accrual-based standard, and then explores the indiana court of appeals' unilateral destruction of that framework in the 2009 case ofwilliams v. adelsperger. i. introduction for the medical patient suffering the consequences of a physician's er­ ror, the world of medicine appears impossibly complex. facing a field overrun with hyper-technical diagnostic tools and increasingly expensive 2011] snatching confusion from nib jaws of clarity 99 treatment options, the average layperson has little chance of gauging whether a poor treatment result stems from physician error or some other aspect of treatment. on the one hand. the cautious patient will wish to re­ main vigilant against unrealistic expectations. on the other hand. to assume infallibility on the part of one's physician discounts one's own suffering while inviting similar harms to the physician's future patients. thus, the patient must navigate between the scylla and charybdis: either act on po­ tentially unfounded suspicion, or risk allowing an act of negligence to go uncompensated and. thus, unpunished. complicating this choice, most states have enacted discovery-based statutes of limitations for medical malpractice actions. these statutes are triggered on the date a plaintiff knew, or should have known of, or in other words, discovered the injury and its negligent cause.1 in indiana, this standard found voice not in statute itself but in judicial construction. in the landmark case of vandusen v. stotts, the indiana supreme court construed indiana's medical malpractice act to permit medical malpractice victims ''to file their claims within two years of the date when they discover the malpractice and the resulting injury or facts that, in the exercise of reasona­ ble diligence, should lead to the discovery of the malpractice and the result­ ing injury.',2 with this pronouncement, the indiana supreme court transmuted an occurrence-based statute of limitations into an accrual-based standard. this accrual-based standard asserted by the indiana supreme court imposed a seemingly impossible challenge on indiana patients, attorneys, and judges: determine the factor(s) a reviewing court will deem sufficient to trigger the statute of limitations in a given case. for some, this confounding exercise might mean filing a lawsuit solely to protect the statute of limita­ tions even before the patient or her attorney knows that a claim exists, leav­ ing the litigant to hope that her suspicions of negligence will find support in the evidence. for the more dutiful litigant, any investigation (including collection and review of medical records or consultation with other physi­ cians) designed to detect or confirm negligence risks a post hoc evaluation of past symptoms, test results, conversations, or diagnoses which, in retro­ spect, should have led to the discovery of the malpractice. now, nearly twelve years after the indiana supreme court announced the accrual-based standard, the waters are no clearer for those maneuvering the medical malpractice shores. each time an indiana court attempts to cre­ ate unity out of the impossibly inconsistent precedent that came before, a subsequent court tears down the transitory edifice of consensus as quickly as it had been built. this frustrating pattern culminated in late 2009 when 1. nancy smith, discovery date in medical malpractice litigation, in 26 am. jur. 3d proof of facts§ 185 (1994). 2. vandusen v. stotts, 712 n.e.2d 491,497 (ind. 1999) (emphasis added). 100 indiana health law review [vol. 8:95 the indiana court of appeals forced ii!edical malpractice litigants back to square one on nearly every principle of discovery rule jurisprudence estab­ lished over the prior decade. part ii of this article tracks the common law evolution of the discovery of malpractice rule as it pertains to indiana's medical malpractice statute of limitations. part iii synthesizes the common law history into a workable framework for future applications of the accrual-based standard. part n explores the indiana court of appeals' unilateral departure from and reimagining of the discovery of malpractice rule in the 2009 case of wil­ liams v. adelsperger.3 ii. the medical malpractice statute of limitations and the devewpment of the discovery rule a. the origins of the medical malpractice statute of limitations in 1975, indiana became the first state4 to pass statutory reform measures to deal with a perceived "health care crisis'.s of rising malpractice insurance costs6 resulting in reduced availability of services. 7 this crisis allegedly brought on by excessive and unjustifiable malpractice judgments and settlements, a failure to identify habitually negligent health care provid­ ers, very large attorney fees, and prolonged time limitations for bringing malpractice actions, 8 prompted the indiana general assembly to pass the medical malpractice act.9 among the five major provisions contained therein, 10 the medical malpractice act (''the act") created a two year statute of limitations applicable to all medical malpractice actions: ''no claim, whether in contract or tort, may be brought against a health care provider based upon professional services or health care rendered or that should have been rendered unless filed within two (2) years from the date of the alleged 3. williams v. adelsperger, 918 n.e.2d 440,442 (ind. ct. app. 2009), trans. denied, 929 n.e.2d 788 (ind. 2010). 4. eleanor d. kinney & william p. gronfein, indiana's malpractice system: no­ fault by accident?, 54 law & contemp. probs. 169, 169 (1991 ). 5. in re stephens, 867 n.e.2d 148, 150-51 (ind. 2007). 6. h.r. 1460 §l(b), 99th gen. assemb., reg. sess. (ind. 1975) (''the effect of[in­ creasing] judgments and settlements, base[ d] frequently on legal precedents, have caused the insurance coverage to uniformly and substantially increase the cost of such insurance cover­ age."). 7. johnson v. st. vincent hosp., inc., 404 n.e.2d 585,589 (ind.1980), abrogated by collins v. day, 644 n.e.2d 72 (ind. 1994), overruled by in re stephens, 867 n.e.2d 148. 8. id. at 590; james r. fisher & debra h. miller, 23 ind. practice series: ind. personal inrjry law & practice § 11:1 (201 0), available at westlaw inprac. 9. 1975 ind. acts 146 (formerly codified at ind. code §16-9.5-1-1); see ind. code§ 34-18 for similar current provisions. 10. bruce d. jones, unfair and harsh results of contributory negligence lives in indiana: the indiana medical malpractice system and tire indiana comparative fault act, 6 ind. health l. rev. 107, 111 (2009). 2011] snatching confusion from the jaws of clarity 101 . . l ,u act, omtsston, or neg ect .... before the passage of the act, the medical malpractice statute of limi­ tations was treated as "occurrence based" by indiana courts. this occur­ rence-based interpretation meant that the occurrence of a negligent act, rather than the discovery of the malpractice and resulting injury, triggered the two-year period. 12 indeed, the occurrence-based interpretation had pre­ vailed in indiana since 1941,13 and subsequent courts continued to apply this approach to the new act. 14 in 1990, the indiana supreme court con­ firmed and formally adopted the occurrence-based standard for the act's statute of limitations. 15 under the occurrence-based standard, a malpractice victim blind to her physician's malpractice, or the resulting injury, enjoyed only one refuge from the harsh effect of the act's statute of limitations. the sole refuge was protection in equity from the physician who intentionally concealed, or failed to disclose, relevant information in an effort to hide either the mal­ practice and/or injury from the patient.16 in these circumstances, equitable estoppel for fraud would preclude the defendant from asserting the statute of limitations as a defense until the termination of the physician-patient re­ lationship in the case of constructive concealment, 17 or when the "patient learns of the malpractice, or discovers information which would lead to dis­ covery of the malpractice if the patient exercises reasonable diligence," in the case of active concealment, whichever came first. 18 yet, to be protected in equity under the narrowly-drawn courtesy of fraud protection demanded a near-herculean showing from the aggrieved victim including: proof of intentional concealment19 or failure to disclose by the defendant,20 reliance 11. ind. code§ 16-9.5-3-1(a) (1971 & supp. 1976) (repealed 1993) (the current statute of limitations is codified in ind. code § 34-18-7-1 (b)( 1998). ). 12. hosp. corp. of am. v. hiland, 547 n.e.2d 869, 872 (ind. ct. app. 1989), adopted in cacdac v. hiland, 561 n.e.2d 758 (ind. 1990); see also toth v. lenk:, 330 n.e.2d 336, 338 (ind. ct. app. 1975)(discussing former ind. code §34-1-2-5 (1971)). 13. martin v. richey, 711 n.e.2d 1273, 1278 n. 6 (lnd 1999). 14. hosp. corp. of am., 547 n.e.2d 869; cyrus v. nero, 546 n.e.2d 328 (ind. ct. app. 1989); jones v. cloyd, 534 n.e.2d 257 (ind. ct. app. 1989); guinn v. light, 531 n.e.2d 534 (ind. ct. app. 1988); ferrell v. geisler, 505 n.e.2d 137 (ind. ct. app. 1987), trans. denied; martin v. rinck, 501 n.e.2d 1086 (ind. ct. app. 1986); spoljaric v. pangan, 466 n.e.2d 37 (ind. ct. app. 1984), trans. denied; colbert v. waitt, 445 n.e.2d 1000 (ind. ct. app. 1982). 15. cacdac, 561 n.e.2d at 759. 16. guy v. schuldt, 138 n.e.2d 891, 894-95 (ind. 1956); toth, 330 n.e.2d at 339. 17. hughes v. glaese, 659 n.e.2d 516, 519 (ind. 1995); guy, 138 n.e.2d at 895; toth, 330 n.e.2d at 339; ostojic v. brueckmann, 405 f.2d 302 (7th cir. 1968). 18. hughes, 659 n.e.2d at 519 (quoting hosp. corp. of am., 547 n.e.2d at 873); toth, 330 n.e.2d at 339-40. 19. guy, 138 n.e.2d at 894 ("before the doctrine of estoppel may be used ... the fraud must be of such character as to prevent inquiry, or to elude investigation, or to mislead the party who claims the cause of action."). 20. !d. at 895 ("usually, there must be some active effort on the part of one to be guilty of concealment but where a fiduciary or confidential relationship exists, such as phy102 indiana heal til law review [vol. 8:95 by the plaintiff, ignorance of the fraud by the plaintiff, and an inability to discover the fraud in the exercise of diligence,21 which required absolute ignorance of any harm or injury and of the malpractice itself.22 moreover, a finding of fraudulent concealment would not extend the statute of limita­ tions two full years from the plaintiff's discovery of the malpractice, but rather, would allow the plaintiff only a ''reasonable" time thereafter in which to initiate suit. 23 even under subsequent amendments and codifications24 of the act's statute of limitations, the occurrence-based standard, with its narrow "fraudulent concealment" exception, prevailed until july 1999. b. creation of the discovery rule in two separate cases decided on july 8, 1999, the indiana supreme court pronounced its departure from the occurrence-based standard. first/5 in martin v. richey,26 the defendant physician failed to correctly diagnose the plaintiff's breast cancer following a needle aspiration, and the defendant further failed to notify the plaintiff that she needed a follow-up excisional biopsy following the needle aspiration?' three years later, the plaintiff ex­ perienced increased pain from the lump in her breast, and a subsequent bi­ opsy revealed adenocarcinoma requiring a radial mastectomy and chemotherapy.28 the indiana supreme court found the medical malprac­ tice statute of limitations unconstitutional as applied to the plaintiff. first, the statute violated the indiana constitution's privileges and immunities sician-patient, there exists a duty to disclose material information between the parties and a failure to do so results in concealment"). 21. toth, 330 n.e.2d at 339. 22. id at 341 (citing withers v. sterling drug, inc., 319 f .supp. 878 (s.d. ind. 1970)) ("it is knowledge of the condition or •injury' rather than its reason that destroys the estoppel and permits the statute to operate."). 23. hughes, 659 n.e.2d at 519; cacdac v. hiland, 561 n.e.2d 758, 759 (ind. 1990). 24. in 1998, the general assembly amended and recodified the statute of limitations. ind. code §34-18-7-1(b) (1998) ("a claim, whether in contract or tort, may not be brought against a health care provider based upon professional services or health care that was pro­ vided or that should have been provided unless the claim is filed within two (2) years after the date of the alleged act, omission, or neglect .... "). in substance, this version (which remains current as of this writing) is identical to the act's original formulation. martin v. richey, 711 n.e.2d 1273, 1278 n. 6 (ind. 1999). 25. though decided the same day, the supreme court considered martin v. richey "the lead case" decided that day. vandusen v. stotts, 712 n.e.2d 491, 493 (ind. 1999). furthermore, justice sullivan cited martin for stare decisis purposes in his van dusen con­ currence and van dusen appears in a later volume of the north eastern reporter 2d than does martin. /d. at 500 (sullivan, j., concurring). but for these facts, one wonders if the martin opinion was necessary at all. see william f. harvey, two cases, two statutes of limitations, a 'new' indiana constitution and one more case pending decision, res gestae, nov. 1999, at 32, 37. 26. martin, 711 n.e.2d at 1273. 27. ld. at 1275-76. 28. id. at 1277. 2011] snatching confusion from the jaws of clarity 103 clause29 "because it is not 'uniformly applicable' to all medical malpractice victims .... " 30 that is, "the statute precludes [the victim] from pursuing a claim against her doctor because she has a disease which has a long latency period and which may not manifest significant pain or symptoms until sev­ eral years after the asserted malpractice."31 second, the statute violated the open courts clause32 "because it requires plaintiff to file a claim before she is able to discover the alleged malpractice and her resulting injury, and, therefore, it imposes an impossible condition on her access to the courts and pursuit of her tort remedy."33 from these rulings, the court did not find that the statute of limitations for medical malpractice claims was unconstitution­ al in general; rather the court declared the statute of limitations unconstitu­ tional as applied to the plaintiff's situation in which she ''was unaware that she had a malignancy and that the cancer had spread to her lymph nodes" until three years after the negligent failure to diagnose?4 that same day, in vandusen v. stotts,35 the indiana supreme court expounded upon martin by purporting to create a framework "to determine how generally to construe or reconstrue the statute of limitations to avoid its unconstitutional application in this case and in future cases."36 in van dusen, the defendant physician "badly misread" a prostate biopsy.37 more than two years later, the plaintiff began experiencing swelling and pain in his groin and lower back.38 follow-up tests revealed incurable prostate cancer.39 looking to its line of fraudulent concealment cases, as well as cases construing the general tort and product liability statutes of limitation, the court construed the act to permit medical malpractice victims ''to file their claims within two years of the date when they discover the malpractice and the resulting injury or facts that, in the exercise of reasonable diligence, should lead to the discovery of the malpractice and the resulting injury.'o4° the indiana supreme court pronounced three principles to help guide the application of this standard. first, "the question of when a plaintiff discov­ ered facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical malpractice and resulting injury, is often a ques­ tion offact.'o41 second, "a plaintiff's lay suspicion that there may have been malpractice is not sufficient to trigger the two-year period[,]" though, "[a ]t 29. ind. const. art. i, § 23. 30. martin, 711 n.e.2d at 1279. 31. martin, 711 n.e.2d at 1279. 32. ind. const. art. i,§ 12. 33. martin, 711 n.e.2d at 1279. 34. id. at 1284-85. 35. vandusen v. stotts, 712 n.e.2d 491 (ind. 1999). 36. id. at 493. 37. id. at 494 (emphasis added). 38. id. 39. id. 40. id. at497. 41. id. at499. 104 indiana health law review [vol. 8:95 the same time, a plaintiff need not know with certainty that malpractice caused his injury, to trigger the running of the statutory time period." 42 finally, "the question may become one of law" where "it is undisputed that plaintiff's doctor has expressly informed a plaintiff that he has a specific injury and that there is a reasonable possibility, if not a probability, that the specific injury was caused by a specific act at a specific time . . ." and in such circumstances, the date the plaintiff receives this information "is the date upon which the two-year period begins to run.'"'3 relying on these principles to choose its "trigger date," the court held that the two-year stat­ ute of limitations began to run on the date the plaintiff's doctor opined that the biopsy slides might have been misread.44 1. does the "discovery of malpractice" rule apply only to medical conditions with long latency periods? in announcing its new construction of the act's statute of limitations in the martin and vandusen cases, the indiana supreme court exposed a litany of questions, the answers to which the court offered only clues. one such question is whether the discovery rule applies only to medical condi­ tions with long latency periods. undeniably, martin and van dusen each dealt with a plaintiff battling "a disease which has a long latency period and which may not manifest significant pain or symptoms until several years after the asserted malpractice.'"'5 yet, the court's analysis in martin leaves room for the interpretation that the martin/van dusen standard should ap­ ply to all medical conditions, not merely the ones with a long latency peri­ od. specifically, in discussing the privileges and immunities clause, the martin court is explicit in its concern over diseases with long latency peri­ ods by defining the subclass of citizens subject to disparate treatment as those with "a disease which may not manifest significant pain or debilitat­ ing symptoms until several years after the initial diagnosis or misdiagno­ sis.'"'6 yet, the discussion in martin ofthe open courts clause invokes no such reliance on long latency periods or the manifestation of pain or symp­ toms. instead, this portion of the court's analysis seems to apply more broadly, emphasizing the ''plaintiff[who] has no meaningful opportunity to file an otherwise valid tort claim within the specified statutory time period because, given the nature of the asserted malpractice and the resulting inju­ ry or medical condition, plaintiff is unable to discover that she has a cause 42. ld at 499. 43. id. 44. id. at 499-500. 45. martin v. richey, 711 n.e.2d 1273, 1279 (ind. 1999) (stating that breast cancer was a medical condition with a long latency period); see also vandusen, 712 n.e.2d at 497 (asserting that prostate cancer was a medical condition with a long latency period). 46. martin, 711 n.e.2d at 1282. 2011] snatching confusion from tile jaws of clarity 105 of action.',..7 by eschewing language of latency, the court implicitly acknowledges· the broader class of medical conditions beyond those with long latency periods.48 in addition, though vandusen explicitly invoked "long latency periods" in establishing its framework, 49 there seems no rea­ sonable basis for limiting use of that :framework only to plaintiffs seeking relief under the privileges and immunities clause but not those seeking re­ lief under the open courts clause. 2. what types of facts will satisfy the standard? another question arising from the martin and vandusen cases in­ volves the facts necessary to satisfy the standards therein. the martin and vandusen opinions offer little guidance as to what facts "in the exercise of reasonable diligence, should lead to the discovery of the medical malprac­ tice and resulting injury." though vandusen highlights the outer bounda­ ries of the inquiry (i.e., that mere lay suspicion of malpractice definitely is not sufficient to trigger the statute of limitations50 but a physician telling a plaintiff that malpractice may have occurred definitely is sufficient51), liti­ gants were left to wonder how to define the middle ground. both martin and van dusen seem to suggest that the appearance or worsening of symp­ toms would not serve as a trigger. the martin court chose to emphasize the 47.. ld. at 1284. 48. summarizing its holding in martin, the van dusen court again highlighted the distinction between those medical malpractice victims protected by the open courts clause versus those. protected by the privileges and immunities clause and invoking long "latency periods" only with regards to the latter: specifically, we held in martin 1hat, under [the open courts clause], the two-year occurrence-based statute of limitations may not constitutionally be applied to preclude the filing of a claim before a plaintiff either knows of the malpractice and resulting injury, or discovers facts, which in the exercise of reasonable diligence. should lead to the discovery of the malpractice and the resulting injury. to do so would be to impose an impossible condition on her access to the courts and pursuit of her tort remedy. we also held that [the privileges and immunities clause] ... requires 1hat the statute of limitations be "uniformly applicable" to all medical malpractice victims, and that, therefore, the statute could not be applied to preclude a plaintiff from filing a claim simply because she bas a disease which bas a long latency period and which may not manifest significant pain or debilitating symptoms until several years after the as­ serted misdiagnosis. vandusen, 712 n.e.2d at 493 (emphasis added). 49. id at497. 50. id at 498 (discussing evenson v. osmose wood preserving co. of america, 899 f.2d 701, 705 (7th cir. 1990)) ("[p]laintiff's mere suspicions regarding the cause of her medical problems in february of 1985 did not trigger the time period .... "). 51. id. at 499 (discussing degussa corp. v. mullens, 695 n.e2d 172, 178 (ind. ct. app. 1998), trans. granted, vacated, 106 n.e.2d 178 (ind. 1998)) ("[t]he statute began to run when her doctor informed her of the possible causal link and the need to investigate fur­ ther."). 106 indiana health law review [vol. 8:95 date of the plaintiff's actual knowledge rather than the date on which the plaintiff "experienced increased pain from the lump in her breast and under her right arm,"52 and the van dusen court chose not to select the date on which plaintiff experienced pain and swelling in the affected area or the date on which the plaintiff realized pain medication was not improving his symptoms. 53 likewise, van dusen seems to suggest that in a failure-to­ diagnose case, the date of a correct diagnosis from a subsequent physician would not serve as a trigger date. of the multiple events that occurred on the trigger date in vandusen, the court did not rely on it being the date a doctor told the plaintiff he had incurable prostate cancer; nor did the court rely on it being the date plaintiff suspected malpractice such that he asked if the biopsy slides had been misread.54 beyond these (vague) clues, however, litigants would have to wait for further explanation and guidance. 3. what does "reasonable diligence" mean? another question brought about by and not answered by the martin and van dusen decisions is the definition of ''reasonable diligence." is "in the exercise of reasonable diligence"55 intended as a hypothetical construct (i.e., the court can envision a hypothetical scenario in which a plaintiff might discover the malpractice and resulting injury after conducting an im­ aginary investigation), or does this clause create a separate requirement of diligent investigation for plaintiffs? if the latter, then what of the plaintiff who does conduct an investigation yet still fails to discover the malpractice and resulting injury? the court provided no standard for what type of in­ vestigation would be diligent and what factors would make an investigation fall short ofbeing diligent. 4. when is the trigger date determination a question of fact, and when is it a question of law? in announcing that ''the question of when a plaintiff discovered facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical malpractice and resulting injury, is often a question of fact,"56 the vandusen court offered little guidance or explanation as to what "often" means, aside from a declaration that the trigger date inquiry "may become one of law" where physician input reveals "a reasonable pos­ sibility, if not a probability, that the specific injury was caused by a specific 52. martin, 711 n.e.2d at 1277. 53. vandusen, 712 n.e.2d at 494. 54. !d. 55. !d. at 493. 56. !d. at 499. 2011] snatching confusion from 1he jaws of clarity 107 act at a specific time .... "51 5. who resolves the questions of factthe court or the jury? related to the prior questio~ the martin and van dusen courts offered no guidance or explanation as to how the questions of fact surrounding the trigger date should be resolved. likewise, these decisions did not clarify whether the determination of what .. reasonable diligence" should uncover was to be made by a court or by a fact-finder. litigants would have to wait almost a full decade before receiving an answer to this question. 58 c. developing the standard (1999-2005) the indiana supreme court's next three pronouncements offered little guidance on how to apply the martin/van dusen standard. only two months after the martin and van dusen decisions, the court, in harris v. raymond,59 ruled that a plaintiff's malpractice action filed after the statuto­ ry period against a dentist for "failure to warn" had been timely. in so hold­ ing, though it did not specify a precise event, the court implied that the trigger date occurred during a two-month window when the plaintiff con­ sulted a doctor for bleeding in her ear, had a piece of the defective implant removed from her head, discovered that the implant had shattered, and dis­ covered that the fda had issued a safety alert regarding the implant.60 of particular interest is the fact that, though the court expressly invoked martin as the basis for its result, the court neither mentioned nor discussed whether a defective implant qualified as a condition with a .. long latency period." instead, the harris court observed that the plaintiff "could not have discov­ ered the alleged negligence within the statutory period, and to apply the statute of limitations would force her to bring a claim before she knew or reasonably could have known of the existence of such claim.'o61 thereafter in halbe v. weinberg,62 a plurality of the indiana supreme court determined that even though the plaintiff ''may have suspected some­ thing was amiss" when she experienced nipple discharge, she did not have .. any reason whatsoever to suspect she bad a cause of action against her doctor" prior to collecting her own medical records and discovering that her implants contained silicone rather than saline. 63 the court appeared to place no significance on the four-year interval between manifestation of 57. ld. (emphasis added). 58. see infra part i.e. 59. harris v. redmond, 715 n.e.2d 388 (ind. 1999), reh 'g denied. 60. id. at 396. 61. ld. at 392. 62. halbe v. weinberg, 717 n.e2d 876 (ind. 1999), reh 'g denied. 63. id. at 882. 108 indiana health law review [vol. 8:95 symptoms and the plaintiff's investigation into her medical records,64 and the court again omitted any discussion of whether breast implants causing nipple discharge qualify as a condition with a "long latency period." inter­ estingly, the plurality seemed to acknowledge (without holding or deciding) that the equitable remedy available for fraudulent concealment remained available to medical malpractice litigants,65 a curious supposition given that the discovery rule would seem to subsume any need for separate inquiry into fraudulent concealment.66 the following year, the indiana supreme court, in boggs v. tri-state radiology, inc., 61 addressed a situation where the trigger date occurred thir­ teen months after the date of malpractice, yet the plaintiff waited another twenty-two and one-half months before initiating suit.68 in a 3-2 majority opinion, the court upheld the trial court's dismissal of the action, holding that an eleven-month window (between the trigger and the expiration of the limitations period two years after the act of malpractice) did not shorten the limitations period "so unreasonably that it is impractical for a plaintiff to file a claim at all.'o69 though the majority opinion appeared to equate the date of a biopsy revealing malignancy with the plaintiff's "knowledge of facts that led to the discovery of alleged malpractice,"70 the court neither discussed nor analyzed its reasons for selecting that particular trigger date, and only a bare-bones factual background is given bereft of reference to that plaintiff's manifestation of symptoms, suspicions, or conversations with physicians. 71 over the next two years, the court of appeals applied the martin/van dusen standard to determine trigger dates in several cases, each time wres­ tling with unanswered questions left by the martin and van dusen courts. 64. id 65. /d. at 881. the two concurring justices would have decided the case on the basis of fraudulent concealment rather than by resort to constitutional challenge. /d. at 882-83 (sullivan, j., concurring). 66. see infra part ll.h. 67. boggs v. tri-state radiology, inc., 730 n.e.2d 692 (ind. 2000). 68. /d. at 694, 699. 69. /d. at 697. 70. /d. at 699. 71. /d. at 694. five years later the court appeared to discount boggs' treatment of the trigger date inquiry: [t]he discussion in boggs summarily referred to a plaintiff's discovery of injury without any specific reference to the discovery of the malprac­ tice itself, or facts that in the exercise of reasonable diligence should lead to the discovery of the malpractice. this observation, however, did not represent a retreat from the rule of martin and van dusen that the dis­ covery date is triggered when a plaintiff either (l) knows of the malprac­ tice and resulting injury or (2) learns of facts that, in the exercise of reasonable diligence, should lead to the discovery of the malpractice and the resulting injury. booth v. wiley, 839 n.e2d 1168, 1172 (ind. 2005). 2011] snatching confusion from tile jaws of clarity 109 for example, in three separate cases decided during this span, the court of appeals selected trigger dates based on the date a plaintiff learned (from a subsequent physician) of a prior misdiagnosis, not the date on which symp­ toms first appeared or worsened.72 likewise, these decisions implicitly re­ ject trigger dates based upon the mere receipt of a correct diagnosis unless that diagnosis is combined with additional information signaling prior er­ ror.73 furthermore, the court of appeals emphasized repeatedly that mere knowledge of the ultimate injury, standing alone, is insufficient to trigger a discovery date.74 in its 2001 rogers v. mendel decision, the court of ap­ peals announced for the first time that where the facts surrounding a trigger date determination are in dispute, ''the judge will be required to resolve dis­ puted facts through pre-trial motion practice ... :m moreover, in shah v. harris, the court of appeals explicitly rejected any suggestion that the mar­ tin/van dusen standard applied only in the context of conditions with "long latency" periods. 76 in early 2002, however, two court of appeals decisions appeared to signal a partial retreat from these prior cases by emphasizing symptomatol­ ogy over physician input. in johnson v. gupta, the court of appeals reinter­ preted martin and van dusen to apply only where a plaintiff suffers no discernible symptoms within two years of the date of malpractice. 77 yet even under this new interpretation, the court of appeals did not select as its trigger the date on which johnson first "knew there was something wrong,'' 72. see rogers v. mendel, 758 n.e.2d 946,948,952 (ind. ct. app. 2001) (concluding that trigger occurred when the second physician diagnosed plaintiff with metastatic cancer, not when plaintiff experienced symptoms of abdominal cramping that led to diagnosis); shah v. harris, 758 n.e.2d 953, 959 (ind. ct. app .. 2001) (holding the statute oflimitations un­ constitutional as applied-two-year period did not begin to run until the date harris "learned that his illness may have been misdiagnosed seven years earlier."); coffer v. arndt, 732 n.e.2d 815, 818, 822 (lnd ct. app. 2000) (concluding that the date plaintiff"learned [from subsequent physician] that he had glaucoma and that he had had it for a long time" served as discovery date, both for purposes of statute of limitations and fraudulent concealment analy­ sis, and the date of temporary blindness did not). 73. rogers, 158 n.e.2d at 948-52 (mentioning that cancer had metastasized already by date of correct diagnosis); shah, 758 n.e.2d at 954, 959 (holding that trigger was satis­ fied by a diagnosis ofb-12 deficiency combined with input from physician .. that [plaintiff's] illness may have been misdiagnosed seven years earlier."); coffer, 732 n.e.2d at 822 (stat­ ing that diagnosis of glaucoma combined with physician input .. that he had had it for a long time" was sufficient trigger''). 74. cf. hopster v. burgeson, 750 n.e.2d 841, 856 (lnd ct. app. 2001) (declining to rule as matter oflaw that patient's death itself was a sufficient trigger; remanding for factual determination as to when personal representative discovered the malpractice); ling v. still­ well, 732 n.e.2d 1270, 1275 (ind. ct. app. 2000) (concluding that though son was "techni­ cally aware of [her] ultimate injury, her death," he had no way of knowing that it might have resulted from malpractice until two years later). 75. rogers, 758 n.e.2d at 952. 76. shah, 758 n.e.2d at 958 (''we find no case law that would support the restriction of the analysis announced in martin and van dusen to specific types of diseases, nor do we discern any public policy or common sense reason for doing so."). 77. johnson v. gupta, 762 n.e.2d 1280, 1283 (ind. ct. app. 2002). 110 indiana health law review [vol. 8:95 the date she first experienced fecal incontinence, or even the date she decid­ ed to seek a second opinion;78 rather, the court of appeals selected the date on which a subsequent doctor told her "that her incontinence was caused by a complete lack of rectal tone."79 as the supreme court would later ex­ plain, "the gupta court expressly recognized that the occurrence-based stat­ ute of limitations does not apply 'in cases where the patient does not suffer symptoms that put the patient on notice that something may have gone wrong in the course of medical treatment "'80 the following month, langman v. milos again mentioned worsening symptoms while (arguably) relying on other factors. 81 in langman, the plaintiff suffered increased pain following podiatric surgery, and be opined to his physician that the surgery bad made his condition worse.82 neverthe­ less, the plaintiff discontinued treatment, and refused to follow any recom­ mendations or referrals prescribed by another physician. 83 rather, the plaintiff abstained from all medical treatment for two and a half years de­ spite worsening symptoms. 84 from this, the court of appeals concluded (without selecting a specific trigger and without identifying a dispositive factor) that "[w]ithin two years of his surgery, and clearly within two years of his last visit to [his physician]," the plaintiff "had enough information that a reasonably diligent person should have discovered the alleged mal­ practice claim .... "8s though langman might be read for the proposition that worsening symptomatology alone may be sufficient to serve as a trig­ ger, it seems equally, if not more, plausible to read langman as the first post-martin/van dusen examination of "reasonable diligence," i.e., that "reasonable diligence" is absent as a matter of law where a plaintiff aban­ dons medical treatment altogether for two and a half years despite worsen­ ing symptoms. just three months later, a different panel of the court of appeals re­ turned to the pre-gupta/langman line of thought in the 2002 case of ja­ cobs v. manhart,86 defendants reported two pap smears as normal.87 in june 1999, the plaintiffbegan to experience bleeding, and adjustment of her medications over the next two months did not improve her symptoms. 88 78. ld. at 1282. 79. id. at 1283. 80. booth v. wiley, 839n.e.2d 1168, 1175 (ind. 2005), quoting johnson, 762 n.e.2d at 1283 (emphasis added by booth). 81. langman v. milos, 765 n.e.2d 227 (ind. ct. app. 2002), abrogated by herron v. anigbo, 897 n.e.2d 444 (ind. 2008). 82. id. at 232, 235. 83. id at 235. 84. id at 235-36. 85. id at 236. 86. jacobs v. manhart. 770 n.e.2d 344 (ind. ct. app. 2002), reh 'g denied, abrogated on other grounds by herron, 897 n.e.2d 444 (ind. 2008). 87. id at 347. 88. /d. 2011] snatching confusion from the jaws of clarity 111 thereafter, an august ·1999 ultrasound revealed a large malignant tumor at which time plaintiff was diagnosed with cervical cancer and, as a result, underwent a radical hysterectomy. 89 following the surgery, plaintiff be­ came curious as to why the results of her previous pap smears had been negative given how quickly her tumor had developed. after collecting her own medical records, she asked a cytotechnologist to review the slides from the prior pap smears "to see if anything may have been missed. "90 the cytotechnologist indicated that some of the slides might have been mis­ read-a conclusion confirmed by a pathologist in april2000.91 in a confusing opinion, the jacobs court initially flirted with the idea that the plaintiff's august 1999 diagnosis of cervical cancer should act as the appropriate trigger, presumably because that was the ''trigger date" ar­ rived at by the trial court. 92 the court of appeals eventually concluded that even assuming this earliest possible trigger date, the six months remaining in the initial two-year statute of limitations was insufficient as a matter of law to afford plaintiff a meaningful opportunity to pursue her malpractice claim. 93 yet, before reaching that conclusion, the court of appeals estab­ lished a range of time in which the actual trigger would have occurred. painting the earliest possible edge of the range, the court of appeals ob­ served that "[ o ]nly after being diagnosed with cervical cancer and learning of the advanced stage of the disease did [the plaintift] possess information which would even give rise to the 'suspicion or speculation of malpractice by a plaintiff who is without technical or medical knowledge"'-a "suspi­ cion or speculation" which the court of appeals acknowledged would be insufficient by itself to serve as a triggering event. 94 locating the latest possible edge of the range, the court of appeals noted that the april 2000 pathologisfs report gave the plaintiffs "more information than they needed to put them on notice that there was a reasonable possibility [of malprac­ tice] and that there was a need to investigate :further."95 apparently settling on the latter date as the appropriate trigger, the court of appeals observed: 89. /d. 90. /d. 91. id. unlike van dusen, where the plaintiff's doctor ad­ vised the plaintiff that there was a reasonable possibil­ ity, if not a probability, that the specific injury was caused by a specific act at a specific time, here there was no such advice. rather, ms. manhart had to first hear the diagnosis of tumor and advanced stage can92. /d. at 352-53 & n.9, 354. 93. /d. at 355. 94. id at 354. 95. id 112 indiana health law review cer, wait for the confirmation, and undergo a radical hysterectomy and the attendant recovery. she then acted with the appropriate dispatch in seeking first an informal opinion and then a formal medical opinion.96 [vol. 8:95 note that in accordance with its 2000-2001 line of cases, the court of ap­ peals in jacobs did not choose as its earliest possible trigger the date on which the plaintiff first began experiencing symptoms, the date on which she first sought medical assistance for her symptoms, or the date she real­ ized her symptoms were not improving under conservative care. thereafter, from 2003 to 2005, the court of appeals bounced back­ and-forth between physician-input-as-trigger and worsening-symptoms-as­ trigger in its application of the martin/van dusen standard. most decisions during this span continued to select trigger dates based upon suggestions of malpractice received from physicians rather than based upon a plaintiffs lay suspicion or symptomatology.97 yet, on two occasions, majority opin­ ions by the court of appeals again relied on symptomatology as a trigger.98 d. the supreme court re-enters the fray (2005) in december 2005, the indiana supreme court for the first time exam­ ined in detail the facts necessary to trigger a discovery date. in booth v. 96. id. 97. see burns v. hatchett, 786 n.e.2d 1178, 1181 & n.2 (ind. ct. app. 2003), trans. denied (assuming without deciding that date subsequent physician "told [plaintiff] she had tmj and that she had a 'clear case of malpractice' against [defendant]" served as trigger); donnan v. osmose, inc., 782 n.e.2d 463, 467-69 (ind. ct. app. 2003), trans. denied (plain­ tiff's lay suspicion combined with ongoing symptoms of swelling and pain over four years insufficient-statute did not begin to nm until physician report connecting illness to treated wood). cf levy v. newell, 822 n.e.2d 234, 238-39 (ind. ct. app. 2005), reh 'g denied (plaintiffs possessed sufficient knowledge when their attorney sent demand letter indicating "strong belief' of malpractice--court did not select date three days after surgery when pa­ tient "began having indications that something was wrong," date of diagnostic test revealing duct injury, or date of admission to hospital for repair of injury). 98. e.g., gyn-ob consultants, llc v. schopp, 780 n.e.2d 1206, 1210-11 & n.5 (ind. ct. app. 2003), trans. denied. relying heavily on johnson v. gupta, 762 n.e.2d 1280, 1283 (ind. ct. app. 2002), the court of appeals held that vaginal swelling and discomfort almost immediately after surgery was sufficient to serve as a trigger in the fraudulent con­ cealment context. in dissent, judge vaidik rejected the symptoms-as-trigger approach and instead concluded that the plaintiff "did not have adequate infonnation that would have led to the discovery of the malpractice" until she collected her own medical records and learned that her physician had operated on the affected area. schopp, 780 n.e.2d at 1212 (vaidik, j., dissenting). thereafter, two justices on the supreme court voted in favor of transfer. 792 n.e.2d 44 (table) (ind. 2003). see also garneau v. bush, 838 n.e.2d 1134, 1142 (ind. ct. app. 2005), trans. denied. the court of appeals held that the trigger occurred after "lise had experienced almost 20 months of pain and extreme difficulty abducting her hip, had spent some eight months in a nursing home, and had been advised by an orthopedic surgeon to have a new bipolar hip prosthesis installed." again, two justices on the supreme court vot­ ed in favor of transfer. garneau, 855 n.e.2d i 004 (table) (ind. 2006). 2011] snatching confusion from the jaws of clarity 113 wiley, defendants recommended and performed lasik surgery on a patient with a history of glaucoma and cataracts.99 the surgery required multiple revisions and eventually resulted in permanent vision loss.100 because plaintiff suffered from problems almost immediately following the surger­ ies, defendants argued that the plaintiff should have discovered the malprac­ tice within two years.101 reversing the trial court's grant of summary judgment, the supreme court first synthesized its prior holdings into a methodology to guide application of the act's statute of limitations: initially, a court must determine the date the alleged malpractice occurred and determine the discovery date--the date when the claimant discovered the al­ leged malpractice and resulting injury, or possessed enough information that would have led a reasonably diligent person to make such discovery. if the dis­ covery date is more than two years beyond the date the malpractice occurred, the claimant has two years after discovery within which to initiate a malpractice action. but if the discovery date is within two years following the occurrence of the alleged malpractice, the statutory limitation period applies and the action must be initiated before the period expires, unless it is not reasonably possible for the claimant to present the claim in the time remaining after discovery and before the end of the statutory period. 102 turning next to the facts of the case at bar, the booth court distinguished between knowledge of injury and knowledge of potential malpractice in selecting a trigger date: while the facts stressed by the defendants in the pre­ sent case demonstrate that mr. booth had knowledge within the period prescribed by the statute of limita­ tions that he had serious vision problems and proba­ ble permanent vision impairment, they do not necessarily establish as an undisputed issue of fact that this amounts to discovery of "facts which, in the exercise of reasonable diligence, should lead to the 99. booth v. wiley, 839 n.e.2d 1168, 1173 (ind 2005). 100. !d. at 1173-74. 101. !d. at 1174. 102. id at 1172. 114 indiana healm law review [vol. 8:95 discovery of the medical malpractice.''103 instead, the court selected as its trigger the date when another physician advised the plaintiff"that the lasik surgery should not have been performed because of his preexisting cataracts and glaucoma."104 in so holding, the booth majority implicitly confirmed the importance of physician input in selecting a trigger date, while, at the same time, discounting the significance of symptom manifestation. yet, the court cautioned against reading its de­ cision as "holding that an expert's advice is always required to put a patient on notice that problems may be due to malpractice."105 instead, the majori­ ty opined (without further explanation or example) that the requisite facts might in some circumstances "arise from a patient's ordinary experiences and observations ... .''106 following the booth court's implicit affirmation that "symptoms aren't enough," the court of appeals again fell in line, reaffirming the im­ portance of physician input in calculating a trigger.107 for example, in the 2006 battema v. booth decision, the court of appeals reversed the trial court's grant of summary judgment. rejecting the contention that post­ surgical scarring was a sufficient trigger, the court instead emphasized the fact that no subsequent physician had opined to plaintiff that her procedure had been performed negligently.108 instead, "battema was aware of an 'un­ fortunate result' shortly after the procedure performed by dr. sally, but she was not necessarily aware that the scarring could have been caused by mal­ practice until she found out that dr. sally was a recovering narcotics addict and had experienced a relapse around the time of the procedure."109 likewise, in palmer v. gorecki, 110 the defendant physician misread the plaintiff's echocardiogram, erroneously diagnosed the plaintiff with en­ docarditis, and initiated a course of antibiotic treatment that resulted in nau­ sea, dizziness, imbalance, and eventual hospitalization.111 the court of appeals held that the plaintiff in that case "reasonably should have known 103. id. at 1175 (quoting vandusen v. stotts, 712 n.e.2d 491,497 (ind. 1999)). 104. id. at 1176. 105. /d. 106. id at 1178-79 (sullivan, j., dissenting) (questioning whether a scenario could exist when expert opinion would not be required under the majority's reasoning.). see also id at 1178 (shepard, c.j., dissenting) (bemoaning that knowledge of injury (without knowledge of associated malpractice) was no longer sufficient to trigger the statute of limita­ tions under the majority's rationale.). 107. battema v. booth, 853 n.e.2d 1014 (ind ct. app. 2006), trans. denied. 108. id at 1020. 109. id see also moyer v. three unnamed physicians, 845 n.e.2d 252, 257-59 (ind. ct app. 2006) (trigger occurred when physician informed plaintiff of possible link between accutane and heart disease-court rejected earlier dates of heart disease diagnosis and open-heart surgery). 110. palmer v. gorecki, 844 n.e.2d 149 (ind ct. app. 2006), reh'g denied, trans. denied. 111. id. at 152. 2011] snatching confusion from the jaws of clarity 115 of the alleged malpractice" eight months after the misreading of the echo­ cardiogram, when a subsequent physician informed him "'there was no cur­ rent evidence for active endocarditis. "'112 the court of appeals did not select the date the plaintiff first experienced adverse symptoms from the antibiotic treatments, the date of his hospitalization from those symptoms, or even the date another physician concluded that the plaintiff's "symptoms were directly related to toxic effects of the antibiotic therapy," and correctly diagnosed the plaintiff with vestibular toxicity.113 e. the 2008 trio ofsupreme court decisions in 2008, the supreme court issued three separate decisions, one by unanimous decision, and two by plurality, which both clarified and (poten­ tially) destroyed many of the principles solidified by the prior nine years of appellate court decisions. yet, before the dust from this upheaval could settle, the court managed to resolve the issues in each of the three cases without necessitating any significant departure from precedent. 1. brinkman v. bueter in brinkman v. bueter,114 the plaintiff suffered from significant head­ aches and seizures that required emergency hospitalization in the days fol­ lowing the birth of plaintiff's first child. 115 plaintiff's obstetrician diagnosed her with preeclampsia, a pregnancy-related medical condition, which, if left untreated, could develop into eclampsia with associated con­ vulsions and eventual coma. 116 though preeclampsia typically develops after the twentieth week of pregnancy,117 the defendant obstetrician con­ vinced plaintiff that her situation was "atypical ... in that [plaintiff] [had] not show[n] [any] signs of preeclampsia until four days after delivery."118 the obstetrician then advised the plaintiff that any future pregnancies would put plaintiff's life at risk and that she should consider sterilization.119 yet, . when plaintiff accidentally became pregnant again five years later, her new obstetrician notified plaintiff that in truth, plaintiff had shown signs of preeclampsia during her first pregnancy that had gone unnoticed and un­ treated. 120 almost immediately, the brinkman court signaled (either intentional112. /d. at 155. 113. /d. at 152. 114. brinkman v. bueter, 879 n.e.2d 549 (ind. 2008). 115. /d. at 550-51. 116. /d. at 551 n.3. 117. /d. at550n.l. 118. /d. at 551. 119. /d. 120. id. at 552. 116 indiana health law review [vol. 8:95 ly or by poor word choice) wholesale changes to the martin/van dusen standard and its nine-year progeny. before examining the facts before it, the brinkman court first summarized its holdings in martin and vandusen as "the statutory period does not begin to run until either the correct diagno­ sis is made or the patient has sufficient facts to make it possible to discover the alleged injury."121 though the court offered no further explanation or justification for the summary, this single sentence could be read to revolu­ tionize discovery rule jurisprudence in indiana. specifically, the court's off-handed proclamation first suggests that the mere receipt of a correct di­ agnosis is itself sufficient to serve as a trigger under the martin/van dusen standard, a curious reimagining which would seem to conflict with the long string of prior cases requiring more. 122 next, this sentence suggests that the martin/van dusen standard allows for triggers based upon the mere possi­ bility of discovery, an inquiry which completely obviates any need for dis­ cussion of "reasonable diligence" or whether certain facts "should lead to the discovery of the medical malpractice and resulting injury."123 and third, this sentence implies that discovery of injury alone (without reference to discovery of malpractice) is the operative trigger, a conclusion which directly contradicts both the van dusen court's original formulation of the discovery rule, 124 and the court's analysis in booth just three years prior. 125 immediately after its off-handed reimagining of the martin/van dusen 121. !d. at 554. 122. see, e.g., burns v. hatchett, 786 n.e.2d 1178, 1181 & n.2 (ind. ct. app. 2003), trans. denied (combining diagnosis of tmj with opinion from subsequent physician that plaintiff had a "'clear case of malpractice' against [defendant]"); jacobs v. manhart, 770 n.e.2d 344, 354 (ind. ct. app. 2002), reh 'g denied, abrogated on other grounds by herron v. anigbo, 897 n.e.2d 444 (ind. 2008) (suggesting that diagnosis of cervical cancer, even when combined with knowledge of the advanced stage of the disease, insufficient to serve as trigger); shah v. harris, 758 n.e.2d 953, 959 (ind. ct. app. 2001) (diagnosis ofb-12 defi­ ciency combined with input from physician ''that [plaintiff's] illness may have been misdi­ agnosed seven years earlier"); rogers v. mendel, 758 n.e.2d 946, 948-52 (ind. ct. app. 2001) (mentioning that cancer had metastasized already by date of correct diagnosis); coffer v. arndt, 732 n.e.2d 815, 822 (ind. ct. app. 2000) (diagnosis of glaucoma combined with physician input "that he had had it for a long time."). cf palmer v. gorecki, 844 n.e.2d at 152, 155 (declining to select date plaintiff correctly diagnosed with vestibular toxicity as trigger); levy v. newell, 822 n.e.2d 234, 238-39 (ind. ct. app. 2005) (not selecting date of diagnostic test revealing duct injury as trigger). 123. vandusen v. stotts, 712 n.e.2d 491,499 (ind. 1999) (emphasis added). 124. !d. at 497 (requiring plaintiffs "to file their claims within two years of the date when they discover the malpractice and the resulting injury or facts that, in the exercise of reasonable diligence, should lead to the discovery of the malpractice and the resulting inju­ ry") (emphasis added). 125. see booth v. wiley, 839 n.e.2d 1168, 1175 (ind. 2005) (distinguishing between knowledge of injury and knowledge of potential malpractice in selecting a trigger date: "while the facts stressed by the defendants in the present case demonstrate that mr. booth had knowledge within the period prescribed by the statute of limitations that he had serious vision problems and probable permanent vision impairment, they do not necessarily establish as an undisputed issue of fact that this amounts to discovery of 'facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical malpractice."'). 2011] snatching confusion from the jaws of clarity 117 standard, the brinkman court continued its onslaught on precedent by re­ viving the debate as to whether the objective standard should apply only in cases involving asymptomatic latency periods. noting that both martin and vandusen involved the failure to diagnose cancer and the impossibility of plaintiffs bringing such claims "before they know they are suffering from the disease,"126 the court stopped short of issuing any declaration regarding the latency issue, noting only that "[t]he brinkmans did not face this chal­ lenge."127 instead, the brinkman court found that the plaintiff should have been aware of the negligent failure to diagnose preeclampsia as soon as she "suf­ fered eclamptic seizures" and ''was immediately diagnosed with and treated for eclampsia."128 by itself, this conclusion implies that the onset of symp­ toms, either alone or combined with the receipt of a correct diagnosis, is sufficient to serve as a discovery date trigger. but rather than concede that brinkman damages the long line of prior cases (including, once again, booth) which rejected the symptoms-as-trigger approach, a more nuanced reading suggests that in actuality, symptomatology did not inform the court's decision. note that the court selected the date of the seizure, hospi­ talization, and diagnosis as its discovery date, rather than the eight-day­ prior hospitalization for severe headaches "unlike any headache in the past," the three-day-prior development of neck pain, the two-day-prior re­ currence of headaches, or the recurrence of nausea and vomiting without any relief from medication. 129 thus, notwithstanding the dicta contained therein and, assuming the court did not intend a distinction between various types of symptoms (e.g., those which require hospitalization and those which do not), the result in brinkman could be read as consistent with mar­ tin, van dusen, booth, and the numerous court of appeals decisions inter­ preting those cases. therefore, the brinkman decision could be interpreted to hold that the appearance or progression of symptoms is not sufficient to serve as a discovery date trigger unless accompanied by a specific diagno­ sis, one which by itself signals the likely presence of a prior, undiagnosed condition. 130 2. overton v. grillo implicitly confirming this reading of brinkman, the indiana supreme 126. brinkman v. bueter, 879 n.e.2d 549, 554 (ind. 2008). 127. id. at 554. 128. id. at 554-55. 129. id at 550-51. 130. the brinkman court emphasized that "preeclampsia is simply a precursor to ec­ lampsia." !d. at 555 n.7. thus, just as metastasis necessarily implies the prior presence of cancer, so too eclampsia necessarily implies the prior presence of preeclampsia. whether a plaintiff in the exercise of reasonable diligence should have known about this relationship, of course, is another question. 118 indiana health law review [vol. 8:95 court again considered ''trigger dates" in overton v. grillo131 wherein the plurality132 addressed yet another case of a plaintiff discovering metasta­ sized cancer shortly after a misread mammogram. in overton, the plaintiff discovered a lump in her right breast fifteen months after the defendant physician reported plaintiff's mammogram as normal.133 an ultrasound and biopsy performed the following week revealed carcinoma of the right breast that had metastasized to the lymph nodes.134 following radiation and chemotherapy, the plaintiff first learned of the possibility of malpractice in a meeting with her attorney one year after discovering the lump in her breast.135 perhaps following brinkman's lead, the plurality crafted another opin­ ion that, if taken at face value, would rewrite the entirety of discovery rule jurisprudence since the incipiency of the martin/van dusen standard. writ­ ing for the plurality, justice boehm first compared overton to the court's 2000 decision in boggs.136 from this comparison, justice boehm conclud­ ed that "[b ]oth mrs. boggs and mrs. overton knew of their condition and that they had not been previously diagnosed. that is enough to put the plaintiff on inquiry notice of the possibility of malpractice .... " 137 this statement appears to impose an "inquiry notice" requirement on medical malpractice victims based on nothing more than the mere receipt of a diag­ nosis. in dissent, justices dickson and rucker correctly observed that "[a ]n injured plaintiff is not required to suspect, investigate, or commence litiga­ tion unless the facts known are sufficiently significant as to create a reason­ able probability that malpractice had occurred."138 the dissenting justices further cautioned against any rule of law which would hinge on "inquiry notice ofthe possibility of malpractice" as any such·rule would "impose on injured patients an obligation of suspicious investigation never envisioned by booth, and [would be] contrary to its express holding. "139 yet in the following paragraph, the overton plurality offers a further explanation for its decision, which appears to rescue both overton and 131. overton v. grillo, 896 n.e.2d 499 (ind. 2008). 132. both overton, 896 n.e.2d 499 and herron v. anigbo, 897 n.e.2d 444 (ind. 2008), reh 'g denied (see discussion ilifra part ii.e.3) are plurality decisions. in each, chief justice shepard concurred in the result without joining in the plurality opinion. 133. overton, 896 n.e.2d at 501. 134. /d. 135. id 136. id at 503 (citing boggs v. tri-state radiology, inc., 730 n.e.2d 692 (ind. 2000). 137. id 138. /d. at 504-05 (dickson, j., dissenting). 139. /d. at 505 (dickson, j., dissenting). the fact that justices dickson and rucker explicitly reject any insinuation of "inquiry notice" or language of "possibility'' into the martin/van dusen standard should inform one's reading of brinkman. as justices dickson and rucker each signed on to the brinlcman opinion just ten months prior to their overton dissent, it seems unlikely that these justices intended to validate brinkman's (careless) word­ ing of the standard to allow triggers based upon the ~ possibility of discovery and, fur­ ther, to allow triggers based upon discovery of injury alone. see supra part ii.e.l. 2011] snatching confusion from tile jaws of clarity 119 brinkman from accusations of rewriting the martin/van dusen standard. comparing its holding with brinkman, the plurality observed that the brink:mans' claim "was untimely because the eclampsia brought to light the potential of the preeclampsia" and, concomitantly, "although no profession­ al had advised the overtons of possible· malpractice, the metastasized can­ cer brought to light the potential that the earlier mammogram had been misread."140 as suggested above,141 this observation allows for a reading of brinkman (and now overton) which is consistent with martin, van dusen, booth, and the numerous court of appeals decisions interpreting those cases, that is, the mere receipt of a diagnosis is not sufficient to serve as a discov­ ery date trigger unless that diagnosis itself signals the likely presence of a prior, undiagnosed condition}42 finally, in an interesting act of jurisprudential acrobatics, the overton plurality attempts a single-sentence reconciliation of overton with booth. implicitly recognizing the conflict with booth (which stressed the im­ portance·of physician input in assigning a trigger date),143 justice boehm offered the following: any potential link between [mrs. overton's] 1999 mammogram and her cancer was not obscured by al­ ternative explanations. see booth v. wiley, 839 n.e.2d 1168, 1174-76 (ind 2005) (holding that trig­ ger date not when plaintiff began having eye prob­ lems because his doctors "continued to present other explanations for the vision difficulties" without men­ tioning the alleged act of malpractice as a potential cause).144 of course, the discerning reader will recall that no such emphasis on "alter­ native explanations" appeared in the booth majority opinion.145 in fact, the quotation offered by justice boehm actually comes from a summary of the plaintiff's argument on transfer and not from any analysis by the booth ma­ jority.146 nevertheless, justice boehm's rewriting of precedent arguably invites an "alternative explanations" exception to the discovery rule, one that is similar in substance and effect to the doctrine of fraudulent conceal­ ment yet requiring no evidence of fraudulent intent. 140. id at 504. 141. see supra part ii.e.l. 142. see supra note 130. again, just as eclampsia necessarily implies the prior pres­ ence of preeclampsia in brinkman, so too metastasis necessarily implies the prior presence of cancer in overton and boggs. 143. see booth v. wiley, 839 n.e.2d 1168, 1176 (ind. 2005). 144. overton, 896 n.e.2d at 504. 145. see supra part ii.d. 146. booth, 839 n.e.2d at 1176. 120 indiana health law revffiw [vol. 8:95 3. herron v. anigbo the same day147 as its decision in overton, the same plurality of the supreme court in herron v. anigbo148 attempted to synthesize the state of the law regarding trigger dates. in herron, the plaintiff sustained a fall at his home that rendered him quadriplegic.149 the following day, the defend­ ant physician performed spinal surgery including placement of a bone graft and plate for purposes of a failed cervical fusion. 150 thereafter, the plaintiff remained in hospitals and care facilities during which he had difficulty speaking, suffered from infection and pulmonary difficulties, and even re­ quired the use of a ventilator for nine months.151 fifteen months later, a subsequent physician notified plaintiff that he "may well require revision surgery" and recommended more tests. 152 five months thereafter, another physician notified plaintiff that his deteriorating condition was likely caused by negligent follow-up care. 153 following another surgery and hospital stay during which he was confmed to a halo, the plaintiff initiated suit against the defendant physician on december 7, 2004, a full thirty-three months after his initial surgery.154 after reciting the objective standard and reiterating the distinction be­ tween triggers that occur before and after the initial two-year window clos­ es, the herron plurality, again led by justice boehm, examined "reasonable diligence."155 noting that ''the critical issue is what reasonable diligence requires, not when the claim accrues or is discovered," justice boehm ex­ plained: "[r]easonable diligence requires more than inaction by a patient who, before the statute has expired, does or should know of both the injury or disease and the treatment that either caused or failed to identify or im­ prove it, even if there is no reason to suspect malpractice."156 note justice boehm's subtle expansion of the discovery rule, announcing for the first time, with neither discussion nor citation to authority, that the knowledge­ of-malpractice prong may be satisfied by mere awareness that one's medi­ cal treatment has failed to improve a medical condition.157 the plurality 147. as it had done with the release of its martin and vandusen opinions, the su­ preme court issued overton and herron on the same day. yet, as with vandusen nine years before, herron appears in a later volume of the north eastern reporter second than its companion decision. see supra note 25. 148. herron v. anigbo, 897 n.e.2d 444, 452 (ind. 2008), reh g denied 149. ld at 447. 150. ld. 151. id. 152. /d. 153. /d. 154. ld. 155. id. at444,448-49. 156. id. at 449. 157. justice boehm appears to ground this addition to the martin/van dusen standard in a reimagining of booth v. wiley, describing the malpractice in that case as "failure to ar2011] snatching confusion from the jaws of clarity 121 then summarized its rationale in brinkman as ''[t]he eclampsia brought to light the potential of the preeclampsia,"158 and it was stated in martin that '"the limitations period started when breast cancer was identified, because the patient was in a position to uncover the failure to identify it in an earlier mammogram .... "159 with that, the herron plurality then turned to the question of whether «reasonable diligence" is to be decided as a question of law or a question of fact. 160 the plurality concluded that the '<trigger date will be tolled as a matter of law when the alleged malpractice was not reasonably discoverable within the limitations period" such as where ''[t]he disease or injury remains latent for an extended period after the alleged malpractice."161 absent such circumstances however, "factual issues relating to the running of the limita­ tions period, such as the date on which the plaintiff first learns of the injury, are to be resolved by the trier of fact at trial."162 the plurality identified "[r]eliance on a medical professional's words or actions that deflect inquiry into potential malpractice" and .. explicit or implicit denial of causation [by a physician]" as examples of such factual issues requiring resolution at tri­ al.163 likewise, .. [t]he physical incapacity of the plaintiff can in limited cir­ cumstances constitute [another] ground for tolling the statute of limitations period,"164 a situation which, like reliance on a medical professional who deflects inquiry, .. ultimately turns on an issue of fact."165 then, in a depar­ ture from at least three prior court of appeals decisions, 166 the herron plu­ rality announced that "factual issues relating to the running of the limitations period, such as the date on which the plaintiff first learns of the injury, are to be resolved by the trier of fact at trial."167 with the foregoing framework established, the herron plurality conrest or cure a known progressive condition such as the degenerative eye condition in booth." !d. at 448. the ad hoc revisions to the booth holding seem to stem more from an aversion to overruling precedent than from fealty to the actual text of the decision. see booth v. wiley, 839 n.e.2d 1168, 1173-74 (malpractice was performance ofill-advised lasik surgery on a less-than-ideal candidate with preexisting conditions which resulted in permanent vision loss, not failure to improve a progressive condition.). 158. herron, 897 n.e.2d at 450 (citing brinkman v. bueter, 879 n.e.2d 549, 555 (fud. 2008)). 159. ld. (citing martin v. richey, 711 n.e.2d 1273, 1275 (fud. 1999)). 160. ld. at 444. 161. ld. at 450-51. 162. id. at 452. 163. id. at 451 (again, justice boehm cites booth v. wiley for this proposition, thereby echoing and compounding the misinterpretation originated in justice boehm's plurality opin­ ion in overton). see also supra part i.e.2. 164. id. 165. id. 166. see rogers v. mendel, 758 n.e.2d 946 (fud ct app. 2001) (requiring factual disputes to be resolved by pre-trial motion practice); jacobs v. manhart, 770 n.e.2d 344 (ind. ct app. 2002), reh 'g denied, abrogated on other grounds by herron, 897 n.e.2d 444; langman v. milos, 765 n.e.2d 227 (fud ct. app. 2002), abrogated by herron, 897 n.e.2d 444. 167. herron, 897 n .e.2d at 452 (collecting extra-jurisdictional cases). 122 indiana health law review [vol. 8:95 eluded that because the plaintiff remained hospitalized following his cervi­ cal fusion surgery and the only evidence offered regarding his failure to investigate for potential malpractice was that the "extent of injuries was not made known to me at that time,"168 the plaintiff's claim, filed thirty-three months post-surgery, was untimely.169 as in overton, justices dickson and rucker dissented, cautioning against watering-down the long-established martin/van dusen/booth standard.170 lll. synthesis: the state of the law as of 2008 from the foregoing history, the following principles emerge: a. the objective standard remains unchanged notwithstanding the potential damage inflicted on the martin/van dusen standard by careless wording and dicta in the indiana supreme court's 2008 trio of decisions, the core of the objective standard remains intact: [w]here the constitutionality of the occurrence-based limitations period as applied to a given case is in is­ sue, the ultimate question becomes the time at which a patient "either (1) knows of the malpractice andre­ sulting injury or (2) learns of facts that, in the exercise of reasonable diligence, should lead to the discovery of the malpractice and the resulting injury."171 for each of these two scenarios, discovery of the "malpractice" and discov­ ery of the "resulting injury'' remain dual requirements stated in the conjunc­ tive. though the brinkman court phrased the standard as to imply that discovery of an injury alone, without reference to discovery of malpractice, is the operative trigger, such an interpretation would directly contradict both the vandusen court's original formulation of the discovery rule172 and the court's analysis in booth just three years prior.173 because of this, it ap168. id 169. id at 453. 170. /d. at 454-56 (dickson, j., dissenting). 171. id at 448-49 (quoting booth v. w'tley, 839 n.e.2d 1168, 1172 (ind. 2005)). 172. vandusen v. stotts, 712 n.e.2d 491, 497 (ind. 1999) (requiring plaintiffs "to file their claims within two years of the date when they discover the malpractice and the result­ ing injury or facts that, in the exercise of reasonable diligence, should lead to the discovery of the malpractice and the resulting injury") (emphasis added). 173. see booth, 839 n.e.2d at 1175 (distinguishing between knowledge of injury and knowledge of potential malpractice in selecting a trigger date: ''while the facts stressed by 2011] snatching confusion from 1he jaws of clarity 123 pears likely that any challenge to the objective standard implicit in the brinkman decision stems from poor word choice rather than the intent of the opinion's signatories. moreover, the inquiry into whether certain facts should lead to discov­ ery, as opposed to whether those facts raise the mere possibility of discov­ ery, remains inviolate. of the three cases potentially challenging this interpretation, two cases, overton and herron, are non-precedential plurali­ ty decisions.174 as for the third case, brinkman, the court's declaration that the statutory period will begin to run when ''the patient has sufficient facts to make it possible to discover the alleged injury''175 is, as before, more like­ ly the product of careless wording than an intent to overhaul the martin/van dusen standard, particularly in light of justices rucker's and dickson's vehement opposition to any rule of law which would hinge on "inquiry no­ tice of the possibility ofmalpractice."176 b. questions of fact vs. questions of law combining the indiana supreme court's reasoning in vandusen v. stotts and herron v. anigbo, the following approach to this issue emerges: "[t]he question of when a plaintiff discovered facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical mal­ practice and resulting injury, is often a question of fact."177 examples of "issues of fact" include ''the date on which the plaintiff first learns of the injury;"178 "[r]eliance on a medical professional's words or actions that de­ flect inquiry into potential malpractice;"179 ''explicit or implicit denial of causation [by a physician];"180 and "[t]he physical incapacity of the plain­ tiff."181 examples of "questions of law" include situations where "it is un­ disputed that plaintiff's doctor has expressly informed a plaintiff that he has a specific injury and that there is a reasonable possibility, if not a probabil­ ity, that the specific injury was caused by a specific act at a specific time .. the defendants in the present case demonstrate that mr. booth had knowledge within the period prescribed by the statute of limitations that he had serious vision problems and proba­ ble permanent vision impairment, they do not necessarily establish as an undisputed issue of fact that this amounts to discovery of 'facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical malpractice."'). 174. "[a] plurality decision is of no precedential value and is not binding upon either the trial court or [the court of appeals]." robinson v. century personnel, inc., 678 n.e.2d 1268, 1271 n.2 {ind. ct app. 1997) (collecting authorities including 20 am. jur. 2d courts, §159 (1995)). 175. brinkman v. bueter, 879 n.e.2d 549, 554 (ind. 2008) (emphasis in original). 176. overton v. grillo, 896 n.e.2d 499, 505 (ind. 2008) (dickson, j., dissenting); see also herron, 897 n.e.2d at 454-56; supra note 139. 177. vandusen, 712n.e.2dat499. 178. herron, 897 n.e.2d at 452. 179. id. at451. 180. id. 181. ld. 124 indiana heal til law review [vol. 8:95 •• ";182 and ''when the alleged malpractice was not reasonably discoverable within the limitations period" such as where "the disease or injury remains latent for an extended period after the alleged malpractice."183 moreover, "factual issues relating to the running of the limitations period ... are to be resolved by the trier of fact at trial,''184 instead of by resort to pre-trial mo­ tion practice.185 c. how the discovery date affects the limitations period if the trigger date falls after the original two-year period expires, be­ ginning from the date of malpractice, then the plaintiff has two years from the trigger date in which to initiate his or her action.186 if the trigger date falls within the original two-year period, then the plaintiff must initiate suit before the expiration of the original two-year period if reasonable in the exercise of due diligence.187 if inadequate time remains in the original two­ year period to initiate suit, then the plaintiff is afforded "reasonable time" after the trigger date to proceed.188 the amount of time that qualifies as ad­ equate or reasonable remains undefined, but a plurality of the indiana su­ preme court has held four months to be "sufficient time to get a claim on file ...... 189 182. vandusen, 712n.e.2dat499. 183. herron, 897 n.e.2d at450-51. 184. /d. at 452. 185. this latter approach had been suggested in at least three court of appeals decisions before the indiana supreme court's resolution of this issue. see rogers v. mendel, 758 n.e.2d 946 (ind. ct. app. 2001) (requiring factual disputes to be resolved by pre-trial mo­ tion practice); jacobs v. manhart, 770 n.e.2d 344 (ind. ct. app. 2002), reh 'g denied, abro­ gated on other grounds by herron, 897 n.e.2d 444; langman v. milos, 765 n.e.2d 227 (ind. ct. app. 2002), abrogated by herron, 897 n.e.2d 444. 186. herron, 897n.e.2dat449. 187. boggs v. tri-state radiology, inc., 730 n.e.2d 692, 697 (ind. 2000). 188. booth v. wiley, 839 n.e.2d 1168, 1172 (ind. 2005). 189. herron, 897 n.e.2d at 453; see also boggs, 730 n.e.2d at 697 (finding eleven month window before expiration of original two-year period did not unreasonably shorten the limitations period); palmer v. gorecki, 844 n.e.2d 149, 155 (ind. ct. app. 2006), reh 'g denied, trans. denied (finding sixteen month window adequate); garneau v. bush, 838 n.e.2d 1134, 1142 (ind. ct. app. 2005), trans. denied (finding four month window ade­ quate); levy v. newell, 822 n.e.2d 234, 239 (ind. ct. app. 2005), reh'g denied (finding fourteen month window adequate); rogers, 758 n.e.2d at 952 (finding ten month window adequate); coffer v. arndt, 732 n.e.2d 815, 822 (ind. ct. app. 2000) (finding twenty-two month window adequate). but see jacobs, 770 n.e.2d at 355 (finding six month window created ''practical impossibility'' of asserting claim before expiration of original two-year period); moyer v. three unnamed physicians from marion county and delaware county, 845 n.e.2d 252, 259 (ind. ct. app. 2006) (finding eleven day window inadequate, but eight­ een month delay between trigger and filing unreasonable). 2011] snatching confusion from lhe jaws of clarity d. analysis not limited to conditions with long latency periods 125 the martin court's analysis leaves room for the interpretation that the martin/van dusen standard should apply to all medical conditions, not merely the ones with a long latency period. rather than dividing the act's statute of limitations into two separate statutes (i.e., one that applies to con­ ditions with long latency periods and one that applies to all other medical conditions)/90 subsequent courts implicitly sided with the all-inclusive in­ terpretation by applying the martin/van dusen standard, though not always in a plaintiff's favor, in cases where plaintiffs suffered ongoing and persis­ tent symptoms from glaucoma, 191 a vitamin b-12 deficiency, 192 immediate post-surgical complications, 193 tmj dysfunction syndrome, 194 and vestibu­ lar toxicity.195 however, the court's decision did not always come out in favor or the plaintiff. amidst all of these decisions, only the court of ap­ peals' opinion in shah addresses the issue head-on: "we find no case law that would support the restriction of the analysis announced in martin and vandusen to specific types of diseases, nor do we discern any public poli­ cy or common sense reason for doing so. nl% though the brinkman court flirted with re-opening this issue in 2008, it stopped short of issuing any declaration regarding the latency issue, not­ ing only that "[t]he brinkmans did not face this challenge [of a condition with a long latency period]."197 had this been its final pronouncement on the issue, the court's restraint should have been sufficient to leave intact the prior nine years of precedent. further bolstering this conclusion, the plurality in herron implicitly confirmed that the trigger date analysis may take place absent a medical condition with a long latency period. supplementing the guidelines as to what qualifies determination as a matter of law, the herron opinion con­ cluded that the ''trigger date will be tolled as a matter of law when the al190. at least one commentator raised this concern at the time the court released the martin and van dusen decisions. see harvey, supra note 25, at 3 7. 191. coffer, 732 n.e.2d 815. 192. shah v. harris, 758 n.e.2d 953 (ind ct. app. 2001). 193. booth, 839 n.e.2d 1168; battema v. booth. 853 n.e.2d 1014 (ind. ct. app. 2006), trans. denied; garneau, 838 n.e.2d 1134; levy, 822 n.e.2d 234; gyn-ob consult­ ants, llc v. schopp, 780 n.e.2d 1206, 1210-11 & n.5 (ind. ct. app. 2003), trans. denied; langman v. milos, 765 n.e.2d 227 (ind ct. app. 2002), abrogated by herron, 897 n.e.2d 444. 194. burns v. hatchett, 786 n.e.2d 1178 (ind ct. app. 2003), trans. denied. 195. palmer v. gorecki, 844 n.e.2d 149 (ind. ct. app. 2006), reh'g denied, trans. denied. 196. shah, 758 n.e.2d at 958. but see &hopp, 780 n.e.2d at 1210 n.5 (analyzing case under fraudulent concealment doctrine rather than under martin/van dusen standard because "the type of latent injury addressed in martin and halbe [v. weinberg} includes situations where the patient does not experience any symptoms that might indicate malpractice."). 197. brinkman v. bueter, 879 n.e.2d 549, 554 (ind 2008). 126 indiana health law review [vol. 8:95 leged malpractice was not reasonably discoverable within the limitations period," such as where a "disease or injury remains latent for an extended period after the malpractice;" and absent such circumstances, ''factual issues relating to the running of the limitations period, such as the date on which a plaintiff first learns of the injury, are to be resolved by the trier of fact at trial."198 in other words, the herron plurality confirms that latency is but one situation where a trigger date may be tolled as a matter of law. if all applications of the martin/van dusen standard required latency as a pre­ condition, then there would be no reason to make room for other situations where a trigger date may be tolled as a matter of law, and there would be no reason to invite factual determinations in other circumstances because there could be no other circumstances. in short, until further comment from the indiana supreme court, latency cannot be viewed as a precondition to ap­ plication of the martin/van dusen standard e. lay suspicion is irrelevant as the indiana supreme court declared during its first pronouncement of the discovery rule, "a plaintiffs lay suspicion that there may have been malpractice is not sufficient to trigger the two-year period."199 following this guidance, not once from the years 1999 through 2008 did any indiana court place any weight on a plaintiff's lay suspicion regarding the possibil­ ity of malpractice when determining a trigger date. indeed, this result is unsurprising given the conceptual disconnect between a plaintiff's subjec­ tive thoughts, feelings, or beliefs, and the inherently objective inquiry at the heart of the martin/van dusen standard 200 moreover, the herron plurality, perhaps unintentionally, indirectly confirmed that lay suspicion cannot serve as a trigger. in herron, the indi­ ana supreme court implies that the language of "reasonable diligence" in the martin/van dusen standard actually creates. a separate requirement of diligent investigation for plaintiffs.2°1 if this is the case, then it becomes a 198. herron, 897 n.e.2d at450-52. 199. vandusen v. stotts. 712 n.e.2d491, 499 (ind. 1999). 200. the seventh circuit court of appeals explained the distinction as it applied to the federal tort claims act: our question, then, is whether the running of the statute of limitations depends on the plaintiffs' personal knowledge and reactions or whether it depends on the reactions of the objective, "reasonable" man. the an­ swer is the latter, an answer reflected in the formula .. knew or should have known". [sic] the first part is actual knowledge, the second is an objective inquiry. a person "should have known" enough when a rea­ sonable man"a reasonably diligent person (in the tort claimant's posi­ tion)" ... would have known enough. nemmers v. u.s., 795 f.2d 628,631 (7th cir. 1986) (internal citation omitted). 201. herron, 891 n.e.2d at 449-50. 2011] snatching confusion from the jaws of clarity 127 logical impossibility for lay suspicion to play any role in the trigger date analysis. consider, in order for a plaintiff to conduct an investigation into whether her physician might have committed malpractice, that plaintiff must harbor some suspicion that her physician has done something wrong. without suspicion, there is no reason to investigate, and to require diligent investigation absent suspicion is to put the proverbial cart before the horse. yet, if suspicion is to serve as a trigger, then the added "reasonable dili­ gence" requirement becomes meaningless. once the suspicion triggers the statute of limitations, there is nothing to be gained by inquiring into whether the plaintiff engaged in a diligent investigation; the bell has already been rung. therefore, "lay suspicion" and "reasonable diligence" cannot coexist logically in the trigger date inquiry. when the indiana supreme court de­ crees the latter, it necessarily vitiates the former. f. worsening symptoms vs. physician notification of probable malpractice from the years 1999 through 2007, the indiana court of appeals and indiana supreme court repeatedly reaff'mned the importance of physician input in calculating a trigger date and routinely rejected any attempt to base a trigger date on manifestation or worsening of symptoms. 202 indeed, even those decisions that purported to rely on symptomatology in selecting a trigger date actually required more. 203 202. see supra part i.c, discussing moyer v. three unnamed physicians from marion county, 845 n.e.2d 252, 257-59 (ind. ct. app. 2006) (trigger occurred when physician in­ formed plaintiff of possible link between accutane and heart disease-court rejected earlier dates of heart disease diagnosis and open-heart surgery); burns v. hatchett, 786 n.e.2d 1178, 1181 & n. 2 (ind. ct. app. 2003), trans. denied (assuming that date the subsequent physician "told [plaintifi] she had tmj and that she had a 'clear case of malpractice' against [defendant]" served as trigger); dorman v. osmose, inc., 782 n.e.2d 463, 467-69 (ind. ct. app. 2003), trans. denied (plaintiff's lay suspicion combined with ongoing symptoms over four years insufficient; statute did not begin to run until physician report connecting illness to treated wood); jacobs v. manhart, 770 n.e.2d 344, 347 & 354 (ind. ct. app. 2002), reh'g denied, abrogated on other grounds by herron, 897 n.e.2d 444 (date pathologist confirmed that some slides had been misread chosen as "trigger"). see also booth v. wiley, 839 n.e.2d 1168, 1175 (ind. 2005) (knowledge of"serious vision problems and probable perma­ nent vision impairment" insufficient; rather, date physician opined ''that the lasik surgery should not have been performed because of his preexisting cataracts and glaucoma" served as trigger); van dusen, 712 n.e.2d at 494, 499-500 (of multiple events which occurred on trigger date, court did not rely on it being date doctor diagnosed incurable prostate cancer; nor did court rely on it being date plaintiff voiced suspicion of malpractice; rather, court relied on it being date on which doctor opined that biopsy slides may have been misread). 203. see supra part i.c, discussing langman v. milos, 765 n.e.2d 227, 236 (ind. ct. app. 2002), abrogated by herron, 891 n.e.2d 444 (emphasizing plaintiff's lack of reasona­ ble diligence); johnson v. gupta, 762 n.e.2d 1280, 1282-83 (ind. ct. app. 2002) (selecting date of physician input as trigger rather than date plaintiff first "knew there was something wrong," date she first experienced fecal incontinence, or even the date she decided to seek a second opinion). 128 indiana health law review [vol. 8:95 finally resolving the issue in the year 2005, the indiana supreme court in booth confirmed the disconnect between knowledge of serious or worsening symptoms and knowledge of"facts which, in the exercise of rea­ sonable diligence, should lead to the discovery of the medical malprac­ tice."204 though the booth court cautioned against reading its decision as "holding that an expert's advice is always required to put a patient on notice that problems may be due to malpractice," the court offered no guidance as to when "a patient's ordinary experiences and observations" might supply the necessary information for a malpractice claim. 205 indeed, this emphasis on physician input persists under the indiana supreme court's subsequent attempts tore-frame the standards from the martin and vandusen cases.206 g. discovery of injury and receipt of correct diagnosis insufficient (usually) the vandusen court's original formulation of the discovery rule207 and the court's analysis in boot~08 combine to confmn that discovery of injury is but one prong of a two-pronged standard. knowledge of injury alone is insufficient to serve as a discovery date trigger. however, because of imprecise language in boggs,209 one might per­ ceive an exception carved out of this rule specific to failure-to-diagnose cases-that the mere receipt of a correct diagnosis, standing alone, could be a discovery date trigger. though the indiana supreme court explicitly re­ jected such a reading,210 later opinions by the court might be read to fuel the fire started by boggs?11 thus, the medical malpractice litigant in indiana is left to ponder the effect of these later indiana supreme court decisions: did the court intend to carve out an exception to the two-pronged standard spe­ cific to failure-to-diagnose cases (and in direct opposition to its rejection of 204. booth, at 839 n.e.2d at 1177. 205. id. at 1176. 206. see herron, 897 n.e.2d at 453 (assuming "trigger date" when plaintiff "was in­ formed of the potential of malpractice" by subsequent physician). 207. vandusen v. stotts, 712 n.e.2d 491, 497 (ind. 1999) (requiring plaintiffs "to file their claims within two years of the date when they discover the malpractice and the result­ ing injury or facts that, in the exercise of reasonable diligence, should lead to the discovery of the malpractice and the resulting injury'') (emphasis added). 208. see booth, 839 n.e.2d at 1175 (distinguishing between knowledge of injury and knowledge of potential malpractice in selecting a trigger date). 209. see discussion supra part i.c; see also supra note 71 (discussing boggs v. tri­ state radiology, inc., 730 n.e.2d 692 (ind. 2000)). 210. booth, 839 n.e.2d at 1172. 211. see overton v. grillo, 896 n.e.2d 499, 503 (ind. 2008) (suggesting that knowledge of metastasized cancer combined with absence of prior diagnosis sufficient to put plaintiff on "inquiry notice" of failure to diagnose cancer); brinkman v. bueter, 879 n.e.2d 549, 554-55 (ind. 2008) (implying that onset of symptoms, either standing alone or com­ bined with diagnosis of eclampsia, is a sufficient trigger for failure to diagnose preeclamp­ sia). 2011] snatching confusion from the jaws of clarity 129 such an approach a mere three years prior), or is there some way to recon­ cile the court's decisions with vandusen and booth? as for the ftrst of these two options, the logical basis of such an ex­ ception would seem dubious in that it assumes an unrealistic level of so­ phisticated knowledge on the part of laypersons. when presented with a diagnosis, what ordinary person is going to recognize and distinguish be­ tween idiopathic and iatrogenic conditions? the average reasonable layper­ son will assume spontaneous emergence of a given medical condition and not fault a medical professional for failing to discover the condition before it existed. by way of example, a layperson diagnosed with a cavity has no reason to suspect that her dentist committed malpractice in failing to diag­ nose the cavity earlier. most reasonable persons would assume that cavity to be idiopathic, unless given reason to doubt its spontaneity. to assume, and therefore require, greater precision in the medical knowledge of layper­ sons is to invite absurdity. as for the latter option, a palatable reconcilia­ tion presents itself. as argued above,212 one might read boggs, brinkman, and overton as acknowledging that certain medical conditions are by their very nature coexistent with other medical conditions. thus, where one di­ agnosis is so inextricably intertwined with another diagnosis (e.g., metasta­ sis with cancer;213 eclampsia with prior preeclampsia214), the mere presence of one impels investigation into the other.215 h. fraudulent concealment remains a viable, yet impotent, doctrine repeatedly, the fraudulent concealment doctrine continues to rear its head in post-martin/van dusen medical malpractice cases.216 nevertheless, 212. see supra part i.e.1-2. 213. see, e.g., overton, 896 n.e.2d 499; boggs, 730 n.e.2d 692. 214. brinkman, 879n.e.2d at555 n.7. 215. at least one medical malpractice litigant in indiana has suggested a second theory of reconciliation (i.e., that a trigger may occur where a subsequent diagnosis necessarily calls into question the interpretation of a prior objective test). see overton, 896 n.e.2d at 501 (mammogram and biopsy revealed advanced cancer metastasized to lymph nodes, thus call­ ing into question why mammogram 15 months prior had been normal). see also boggs, 730 n.e.2d at 694-95 (plaintiff "became aware of her injury'' when biopsy revealed advanced cancer metastasized to liver, thus calling into question why prior year's mammogram had revealed nothing); conway v. schneider, no. 49a02-0906-cv-513, 2010 wl 653004, at *5 (ind. ct. app. feb. 24, 2010) (mri revealing rotator cuff tear brought to light potential that mri two years prior had been misread); rogers v. mendel, 758 n.e.2d 946, 952 (ind. ct. app. 2001) (trigger occurred when diagnosed with metastatic endometrial cancer, thus call­ ing into question why post-hysterectomy tests 14 months prior had revealed nothing). nev­ ertheless, such a reconciliation obviously fails to account for the result in brinkman. 216. see, e.g., boggs, 730 n.e.2d at 699 (even assuming fraudulent concealment, stat­ ute not tolled beyond original discovery date); halbe v. weinberg, 717 n.e.2d 876, 882-83 (ind. 1999) (acknowledging but declining to discuss fraudulent concealment in light of dis­ position, with justices sullivan & boehm concurring on grounds of fraudulent concealment); 130 indiana health law review [vol. 8:95 the fraudulent concealment doctrine has devolved into irrelevance in the medical malpractice context in two ways: (1) the doctrine is unnecessary as a practical matter; and (2) the doctrine is superfluous under the martin/van /jtlsen standard. first, the fraudulent concealment doctrine became unnecessary with the court's pronouncement of the discovery rule in martin/van dusen. consider: for the fraudulent concealment doctrine to apply, one must envi­ sion a scenario where a plaintiff discovers some fact x which should lead to discovery of the malpractice and resulting injury, and yet, because of fraud by the defendant physician, plaintiff fails to uncover the malpractice. in this scenario, one wonders if any qualitative distinction can be drawn be­ tween saying, "x should lead to discovery but,· under these circumstances, did not," and saying "under the circumstances, x might not lead to discov­ ery." if the fact-finder is allowed to take into account the defendant's con­ duct when assessing whether x should lead to discovery of malpractice, then fraudulent concealment is no longer needed as an independent doctrine. if the fact-finder is not allowed to take into account the defendant's conduct when assessing whether x should lead to discovery of malpractice, then one wonders what (if anything) is to be gained by forcing the fact-finder to dis­ regard the defendant's conduct until after assessing the hypothetical signifi­ cance of x in a vacuum. at best, fraudulent concealment persists only as a contrived exercise. yet even if one could justify divorcing the examination of what x might or might not reveal (after a hypothetical "diligent" investigation) from the surrounding circumstances (i.e., the physician's fraudulent con­ cealment), a more fundamental problem emerges, one that calls into ques­ tion the continued viability of fraudulent concealment as an independent doctrine. recall that under the pre-act fraudulent concealment doctrine, the defendant was estopped from asserting the statute of limitations until the earlier of the termination of the physician-patient relationship, or the date at which "the patient learn[ed] of the malpractice or learn[ed] information which would lead to discovery of the malpractice if the patient exercised palmer v. gorecki, 844 n.e.2d 149, 155-56 (ind. ct. app. 2006) (finding no fraudulent con­ cealment where plaintiffs failed to establish that "concealment of material information somehow prevented them from inquiring into or investigating [victim]'s condition, thus pre­ venting them from discovering a potential cause of action."); battema v. booth, 853 n.e.2d 1014, 1021 (ind. ct. app. 2006) (fact issue as to whether fraudulent concealment present where physician lied to patients about cause of physician's eye injury and failed to disclose physician's narcotics addiction); garneau v. bush, 838 n.e.2d 1134, 1143 (ind. ct. app. 2005) (fraudulent concealment inapplicable where no evidence of concealment); gyn-ob consultants, llc v. schopp, 780 n.e.2d 1206, 1210-11 (ind. ct. app. 2003) ("despite the evidence of concealment," statute not tolled beyond date patient "experienced discernible symptoms."); burns v. hatchett, 786 n.e.2d 1178, 1185 (ind. ct. app. 2003) (no fraudulent concealment where no evidence of actual knowledge or intentional conduct by physician); coffer v. arndt, 732 n.e.2d 815, 821-22 (ind. ct. app. 2000) (even assuming fraudulent concealment, statute not tolled beyond original discovery date). 2011] snatching confusion from the jaws of clarity 131 diligence ... .'m7 note that this latter category is merely a reiteration of the discovery rule. in other words, if fraudulent concealment remains viable, then logically there can never be a situation where fraudulent concealment could extend the trigger date beyond that mandated by the martin/van dusen standard; as a practical matter, fraudulent concealment becomes ir­ relevant under any accrual-based statute oflimitations.218 perhaps recognizing the doctrine's overlap with the martin/van ditsen standard, the court of appeals in gyn-ob consultants, llc v. schopp at­ tempted to resurrect the doctrine with a creative reimagining.219 conclud­ ing that the martin/van dusen standard applies only where the plaintiff suffers from a latent, asymptomatic condition, the schopp majority pro­ ceeded to apply the discovery rule anyway under the rubric of fraudulent concealment. 220 in so doing, the schopp court implied that fraudulent con­ cealment should be perceived as an alternative to the martin/van dusen standard rather than as a complement to it, while at the same time, tacitly acknowledging that the analyses are cot~ous.221 no other indiana court has adopted this approach, however. given the problematic assumption on which the court of appeals relied in invoking the doctrine,222 it seems im­ probable that future indiana courts will mimic the schopp approach. l "reasonable diligence" requires investigation, not complete inactivity of all the questions left unanswered by martin and van dusen, the 217. see toth v. lenk. 330 n.e.2d 336, 339-40 {1975); supra part i.a. see also hughes v. glaese, 659 n.e.2d 516, 519 {ind. 1995); guy v. schuldt, 138 n.e.2d 891, 895 {ind. 1956). 218. see, e.g., conway, 2010 wl 653004, at *6 (even assuming fraudulent conceal­ ment, statute not tolled beyond date of physician's last opportunity to diagnose, which fell even before discovery date); &hopp, 780 n.e.2d at 1210-11 ("despite the evidence of con­ cealment," statute not tolled beyond date patient "experienced discernible symptoms."); coffer, 732 n.e.2d at 821-22 (even assuming fraudulent concealment, statute not tolled be­ yond original discovery date). the supreme court flirted with this realization in boggs, abandoning the discussion just before stepping off the precipice: even if discovery were to establish that the physician-patient relation­ ship [continued until the august 12, 1992 trigger date] . . • or that tri­ state's radiologist had information he should have disclosed to carolyn, the statute of limitations would not be tolled beyond august 12, 1992, the date of carolyn's biopsy and knowledge of facts that led to discovery of the alleged malpractice. thus, under any of these theories, carolyn would have only a reasonable time beyond august 1992 to file her claim. boggs, 730 n.e.2d at 699. 219. schopp, 780 n.e.2d 1206. 220. /d. at 1210-ll. 221. id. at 1210 n.5 ("we accordingly believe the patient's claim is more usefully ex­ amined as one of concealment rather than as a constitutional question."). 222. see supra part ll.d. 132 indiana health law review [vol. 8:95 meaning of "reasonable diligence" has received the least treatment. though no case prior to herron spoke directly to the meaning of "reasonable dili­ gence," most decisions seemed to treat it as an invitation to engage in thought-experiments (i.e., whether the court can envision a hypothetical scenario in which a plaintiff might discover the malpractice and resulting injury after conducting an imaginary investigation) and yet, with herron, the supreme court implies that "reasonable diligence" actually creates a separate requirement of diligent investigation for plaintiffs.223 thus, a plaintiff who engages in no investigation whatsoever during the initial two­ year period, because he does not understand the extent of his injuries, will not be excused from the harsh result of the occurrence-based statute of limi­ tations;224 nor does the discovery rule save the plaintiff who buries his head in the sand and eschews all medical treatment for two-and-a-half years de­ spite worsening symptoms.225 left unanswered by herron, however, is whether a plaintiff can investigate with ''reasonable diligence" yet still fail to uncover facts necessary for a trigger date. iv. the indiana court of appeals careens off the tracks with its trio of decisions in 2008, the indiana supreme court threat­ ened to tear asunder the few areas of clarity established during the previous decade in the jurisprudence surrounding the act's statute of limitations. in december 2009, the indiana court of appeals attempted to make good on this threat by singlehandedly undermining most (if not all) of those areas of clarity. a. thefacts in june 1999, ten-year-old anna williams needed braces.226 anna be­ gan orthodontic treatment with the defendant physician, dr. adelsperger.227 after more than two years of orthodontic treatment, anna began to experi­ ence pain in her jaw.228 when pain medication failed to ameliorate anna's symptoms, dr. adelsperger dismissed the complaints as related to the de­ velopment of wisdom teeth.229 x-rays of anna's jaw revealed that anna's left condyle had "flattened," a preliminary indicator of temporomandibular 223. herron v. anigbo, 897 n.e.2d 444, 449-50 (lnd 2008). 224. /d. at 453. 225. langman v. milos, 765 n.e.2d 227, 235-36 (ind. ct. app. 2002), abrogated by herron, 897 n.e.2d 444. 226. williams v. adelsperger, 918 n.e.2d 440, 442 (ind ct. app. 2009), trans. denied, 929 n.e.2d 788 (ind 2010). 227. id 228. id 229. id 2011] snatching confusion from 1he jaws of clarity 133 joint dysfunction ("tmj"}.230 nevertheless, dr. adelsperger continued treating anna with braces. 231 by mid-2002, anna was experiencing pain on both sides of her jaw, a locking sensation, and "clicking and popping" in her jaw, yet another indi­ cator oftmj.232 though she suspected tmj, dr. adelsperger chose not to refer anna to a tmj specialist.233 instead, dr. adelsperger questioned an­ na about possibly grinding her teeth, instructed her to take painkillers, and fitted anna with a soft mouth guard, a treatment known to exacerbate many types of tmj?34 as anna's symptoms continued to worsen, dr. adelsper­ ger told anna's mother that anna had a muscle problem, not a joint prob­ lem, and implied that anna was exaggerating her complaints. 235 eventually, dr. adelsperger referred anna to dr. heidi crow, a col­ league and former teacher of dr. adelsperger's.236 dr. crow told anna's family that the symptoms were psychosomatic or that anna might have lu­ pus, but ''that anna definitely was not suffering from tmj syndrome[. ]"237 disagreeing with dr. crow's diagnoses, anna next sought treatment from a pain management specialist.238 the pain management specialist di­ agnosed anna with tmj syndrome and referred anna to a tmj special­ ist.239 nevertheless, when anna's mother phoned dr. adelsperger to discuss the diagnosis, dr. adelsperger again assured her that anna was not suffering from tmj, and she further advised against taking anna to the spe­ cialist because the specialist was "money hungry."240 after requesting a second referral from the pain management specialist, anna's mother again spoke to dr. adelsperger; this time, dr. adelsperger insisted that the se­ cond specialist was "not the right person" to treat anna.241 based on this advice, anna never saw the tmj specialists. 242 in december 2002, anna's family took her to a new orthodontist.243 on the intake questionnaire, anna's mother wrote "referral-prior insuffi­ cient care" and "suspected tmj-splints made-exasperated [sic] prob­ lem. "244 after several months of orthotic treatment, an mri that revealed tmj damage, and two surgeries, anna became pain-free by february 230. /d. at 442-43. 231. /d. at 443. 232. /d. 233. /d. 234. /d. 235. id 236. /d. at 443 & n.5. 237. /d. at 443 & n.6. 238. id at 443-44. 239. /d. at 444. 240. /d. 241. id 242. /d. 243. /d. 244. /d. 134 indiana health law review [vol. 8:95 2005.245 because of the mri results, anna's father met with dr. adelsperger in september of 2003.246 during this meeting, dr. adelsperger assured an­ na's father that "her treatment had been appropriate and she had met the standard of care in" her treatment of anna.247 suspecting negligence, an­ na's father asked the indiana dental association to evaluate the case. 248 the association concluded its review in december 2003 without finding negligence against dr. adelsperger.249 nevertheless, anna's family initiat­ ed suit in december 2004.250 b. the court's analysis affirming the trial court's grant of summary judgment to dr. ad­ elsperger, the court of appeals in williams v. ade/sperger adopted a scatter­ shot approach to judicial review by blindly throwing several justifications for its decision against the wall in the hopes that one or more might stick. unfortunately for future medical malpractice litigants in indiana, none do. after summarizing the factual background, the standard of review for grants of summary judgment, the act's statute of limitations, and some of the case law developing the martin/van dusen standard/51 the court of ap­ peals began its analysis with its conclusion: "williams had ample infor­ mation during the limitations period that, in the exercise of reasonable diligence, should have led to the discovery of the malpractice she alleg­ es."252 with that, the unanimous panel announced its reasoning: 245. id 246. id 247. id 248. id. 249. id. 250. id. unlike [the plaintiffs tumor in van dusen] wil­ liams's disorder was not latent-the symptoms were obvious and williams's parents knew they had wors­ ened under the doctor's care. nor was williams without a correct diagnosis until after the limitations period had run, as was [the plaintiff in shah v.] har­ ris. by october of2002, dr. liu had diagnosed tmj. in july 2003, doctors sondhi and biggs noted they had begun orthotic therapy in an effort to resolve wil­ liams's "symptoms of clicking and pain in the right and left temporomandibular joints." they noted there 251. id. at 442-46. 252. id. at446-47. 2011] snatching confusion from 1he jaws of clarity had been some improvement, but it was "unlikely that continuation of orthotic therapy beyond this point will result in any further improvement." in september 2003, about a year after williams's last treatment by the doctor, dr. buttram told williams's parents she had, among other conditions, tmj. williams brought her action too late, even though no doctor had explicitly indicated there had been mal­ practice, because the trigger to action may occur when symptoms develop or worsen during or after a medical treatment and accordingly put a plaintiff on notice of potential mistreatment or improper care .... [discussion of the pre-booth v. wiley case of levy v. newelf53]. similarly, williams believed early on that the doc­ tor's treatment had caused or exacerbated her condi­ tion. one doctor had diagnosed tmj about two months after williams' last treatment by the doctor, and another diagnosed tmj less than a year after that, when about eleven months remained in the limitations period. williams had sufficient information and time within which to bring her claim. we cannot say summary judgment for the doctor was error, and we accordingly affirm.254 c. dissecting the court's rationale 135 without belaboring the haphazard manner in which the court of ap­ peals presented its reasoning, the above analysis is even more unsatisfying for its substantive shortcomings. each rationale that might be gleaned from the foregoing analysis conflicts with principles firmly established by mar­ tin, vandusen, booth, and their progeny. 1. rationale #1: non-latency rationale: "unlike [the plaintiff's tumor in vandusen], williams's disorder was not latent-the symptoms were obvious and williams's parents knew they had worsened under the doctor's care.'ass 253. levy v. newell, 822 n.e.2d 234 (ind. ct. app. 2005), reh g denied (finding four­ teen month window adequate). 254. williams, 918 n.e.2d at 447-48 (citations omitted). 255. !d. at447. 136 indiana health law review [vol. 8:95 court's error: by stressing the distinction between latent and non­ latent conditions, the court of appeals takes the final step the brinkman court had been unwilling to take. before williams, the court of appeals had rejected, both implicitly and explicitly, the invitation to divide the act's statute of limitations into two separate statutes (i.e., one that applies to con­ ditions with long latency periods and one that applies to all other medical conditions).z56 though the supreme court in brinkman flirted with re­ opening the latent vs. non-latent debate, it stopped short of issuing any dec­ laration regarding the latency issue, thereby leaving intact the prior nine years of precedent. by addressing the issue itself (rather than awaiting a pronouncement from the indiana supreme court), the williams court makes it impossible for future litigants, attorneys, and trial judges to predict whether a given panel of the court of appeals will rely on the latent vs. non­ latent distinction in any given case.257 2. rationale #2: correct diagnosis rationale: ''nor was williams without a correct diagnosis until after the limitations period had run, as was harris.'.258 · court's error: here, the court of appeals leaves indiana litigants with the impression that the statute of limitations in a failure-to-diagnose case is triggered as a matter of law as soon as the plaintiff receives a correct diag­ nosis from a subsequent physician. as explained above/59 this position collapses under the weight of both logic and precedent. williams did not involve a situation where one diagnosis is inextricably intertwined with an­ other; the diagnosis of tmj did not call into question the interpretation of a prior objective test; nor does the court of appeals offer any reason why the plaintiff should have doubted that her tmj was idiopathic. again, the court of appeals charts a new course, thereby leaving future litigants, attorneys, and trial judges without a reliable guide. 3. rationale #3: worsening symptoms rationale: "williams brought her action too late, even though no doc­ tor had explicitly indicated there had been malpractice, because the trigger to action may occur when symptoms develop or worsen during or after a medical treatment and accordingly put a plaintiff on notice of potential mis256. see supra part ii.d. 257. see also conway v. schneider, no. 49a02-0906-cv-513, 2010 wl 653004, at *6 (ind. ct. app. feb. 24, 2010) (repeating the error of the williams court when stating "nancy was not suffering from a latent or undiscovered condition, as she knew from the time of the fall that she was experiencing significant pain."). 258. williams, 918 n.e.2d at 447. 259. see supra part ii. g. 2011] snatching confusion from the jaws of clarity 137 treatment or improper care."260 court's error: with this statement, the court of appeals leaves indi­ ana litigants with the impression that worsening symptoms is pertinent to the tri~er date inquiry, a position put to rest by the supreme court in 2005.2 1 to borrow language from booth, though the williams plaintiffs knew that anna suffered from worsening jaw problems and probable jaw damage, this "do[ es] not necessarily establish as an undisputed issue of fact that this· amounts to discovery of 'facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical malpractice. "'262 in­ deed, even under justice boehm's strained re-examination of booth in overton,263 both dr. adelsperger and a subsequent physician provided plaintiffs with multiple alternative explanations for the worsening symp­ toms, including grinding, emergence of wisdom teeth, muscle problems, symptom exaggeration, lupus, and that anna's symptoms were psychoso­ matic. 264 in short, one is hard-pressed to invent any means of reconciling the above rationale with booth. yet as support for its departure from booth, the williams court relies on the pre-booth case of levy.265 a closer reading of levy, however, re­ veals that even in that case, the court of appeals did not select as its trigger the date three days after surgery when the patient "began having indications that something was wrong"; it did not select the date of the diagnostic test revealing the duct injury; and it did not select the date of the patient's ad­ mission to the hospital for repair of that injury.266 rather, the levy court selected as its trigger the date the plaintiffs consulted with an attorney who then sent a demand letter indicating a '"strong' belief' of malpractice.267 thus, even relying on outdated and irrelevant precedent, the williams court misfires. to suggest that levy placed any weight whatsoever on the mani­ festation or worsening of symptoms is, at best, confusing. 4. rationale #4: lay suspicion rationale: "similarly, williams believed early on that the doctor's treatment had caused or exacerbated her condition.'.268 court's error: here, the court of appeals invites the interpretation 260. williams, 918 n.e.2d at 447. 261. see supra part ii.f. 262. booth v. wiley, 839 n.e.2d 1168, 1175 (ind. 2005) (quoting vandusen v. stotts, 712 n.e.2d 491, 497 (ind. 1999)). 263. see supra part i.e.2. 264. williams, 918 n.e.2d at442-43. 265. /d. at 447-48 (citing levy v. neweu, 822 n.e.2d 234, 238-39 (ind. ct app. 2005)). 266. levy, 822 n.e.2d at 238-39. 267. /d. at 239 . . 268. williams, 918 n.e.2d at 448. 138 indiana health law review [vol. 8:95 that lay suspicion is pertinent to the trigger date inquiry. as explained above,269 not once in the ten-year span from 1999-2008 did any indiana court place any weight whatsoever on a plaintiffs lay suspicion regarding the possibility of malpractice when determining a trigger date, and the su­ preme court implicitly confirmed the irrelevance of lay suspicion in her­ ron.210 once again, the williams court charts its own course. · yet even setting aside. the precedent-ignoring flaws in its reasoning, the court of appeals wrought further havoc by deciding implicitly one of the few questions left open by herron.211 by creating a separate requirement of diligent investigation for plaintiffs,272 herron left open the question of whether a plaintiff can investigate with "reasonable diligence" yet still fail to uncover facts necessary for a trigger date. without even addressing the issue, the court of appeals in williams appears to answer this question in the negative. when he first suspected negligence, anna's father confronted the de­ fendant physician with his suspicions.273 dr. adelsperger denied any wrongdoing and assured anna's father that her treatment of anna had been appropriate and she had met the standard of care.274 thereafter, anna's fa­ ther asked the indiana dental association to review the case. 275 the asso­ ciation concluded its review in december 2003 without finding negligence against dr. adelsperger.276 thus, not only did the plaintiff's father exercise "reasonable diligence" by confronting dr. adelsperger with his suspicions of negligence, the ''reasonable diligence" continued with his initiation of an administrative review. yet each step of the way, his suspicions were re­ buffed. in other words, it would appear that the williams plaintiff did exer­ cise "reasonable diligence," yet his diligent investigation led to (1) a defendant who actively attempted to convince the plaintiff that no malprac­ tice had occurred; and (2) an administrative review panel that declined to find negligence on the part of the defendant. thus, williams invites future courts to substitute their own suppositions as to what the "exercise of rea­ sonable diligence" might have uncovered when faced with evidence that a plaintiff did exercise reasonable diligence yet still failed to discover facts which would lead a reasonable person to discover the malpractice. finally, it appears plain that the court of appeals in williams ignored explicit direction from the indiana supreme court as to what does and does not qualify for determination as a matter of law. one cannot overlook the 269. see supra part ii.e. 270. see supra part ii.e. 271. herron v. anigbo, 897 n.e.2d444, (ind. 2008). 272. id. at 449-50. 273. williams, 918 n.e.2d at 444. 274. id 275. id 276. id 2011] snatching confusion from the jaws of clarity 139 fact that all of the determinations in williams were made as a matter of law without any input from a fact-finder. as explained above,277 "the question of when a plaintiff discovered facts which, in the exercise of reasonable diligence, should lead to the discovery of the medical malpractice and re­ sulting injury'' is to be treated as a question of fact, 278 absent two very spe­ cific circumstances, i.e., (1) where "it is undisputed that plaintiff's doctor has expressly informed a plaintiff that he has a specific injury and that there is a reasonable possibility, if not a probability, that the specific injury was caused by a specific act at a specific time .... ";279 and (2) ''when the al­ leged malpractice was not reasonably discoverable within the limitations period" such as where a "disease or injury remains latent for an extended period after the alleged malpractice .• .2so "reliance on a medical profession­ al's words or actions that deflect inquiry into potential malpractice" and "explicit or implicit denial of causation [by a physician]" are examples of factual issues requiring resolution at trial.281 using these guidelines, it is clear that williams should have been re­ manded for factual assessment. neither of the circumstances identified by the supreme court requiring determination as a matter of law were present in williams, and the record in williams is littered with evidence of "[r]eliance on a medical professional's words or actions that deflect inquiry into potential malpractice" and "explicit or implicit denial of causation,'.282 including repeated assurance from the defendant that anna's complaints were nothing more than muscle, wisdom tooth, and (later) psychosomatic pain;283 diagnosis from the defendant's colleague and teacher that anna's complaints were either psychosomatic or related to lupus;284 successful ef­ forts by the defendant to convince anna's family to reject the diagnosis of tmj by a subsequent physician;285 successful efforts by the defendant to convince anna's family not to consult with the tmj specialists recom­ mended by a subsequent physician;286 and an explicit denial of negligence by the defendant.287 yet rather than adhere to the supreme court's guid­ ance by turning these facts over to a jury, the williams court chose to weigh (and ultimately disregard) these facts in the jury's stead. 277. see supra part ll.b. 278. vandusen v. stotts, 712 n.e.2d 491, 499 (ind. 1999). 279. id 280. herron v. anigbo, 897 n.e.2d 444, 450-51 (ind. 2008). 281. id at 451. 282. /d. 283. williams v. adelsperger, 918 n.e.2d 440, 442-43 (ind. ct. app. 2009), trans. denied, 929 n.e.2d 788 (ind. 2010). 284. /d. at 443-44 nn.5-6. 285. /d at 444. 286. id 287. /d. 140 indiana health law review [vol. 8:95 v. conclusion taken with the aforementioned departures from precedent, the indiana court of appeals' refusal to remand for factual assessment supplies the fin­ ishing stroke to the masterpiece of activist reinvention that is williams. not one of the principles established over the prior decade remains unsullied by williams,288 and litigants, attorneys, and trial judges are left with no idea how to proceed in future medical malpractice cases. as indiana courts chart a new course, those navigating the murky waters are as likely to need an oracle as they are a compass. 288. as if to leave no stone unturned, the williams court addressed fraudulent con­ cealment, as well. implying that fraudulent concealment remains a viable doctrine, the court of appeals concluded that fraudulent concealment only applies where the physician has pre­ vented the plaintiff :from "inquiring into or investigating her condition ...• [here], williams was able to, and did, inquire into and investigate her condition within the limitations period." id at 442 n.l. the case for pharmacists as legal health care providers erin albert• i. introduction ................................................................................ 188 ii. background ................................................................................. 191 a. the state of pharmacy without provider status .................... 191 b. legislative history and the scope of pharmacy practice expanding ..................................................................................... 193 c. possible model for pharmacists to obtain provider status: the nurse practitioner ..................................................... 195 ill. analysis ........................................................................................ 197 a. pharmacists are already providing health care .................. 197 i. provision of immunizations ................................................ 197 2. medication therapy management (mtm) .......................... 200 3. the medical home and collaborative practice agreements ................................................................ 205 4. emergency preparedness and response ............................. 207 b. pros and cons of pharmacists as legal health care providers ............................................................................. 209 1. physicians' and professional organizations' opinions on pharmacists as legal health care providers .................... 209 2. pharmacist professional societies and support of pharmacists as legal providers .............................................. 211 3. liability and provider status .............................................. 212 iv. conclusion .................................................................................. 213 v. addendum ...................................................................................... 213 *j.d. candidate, 2012, indiana university robert h. mckinney school of law; phann.d., 2005, shenandoah university; m.b.a., 2001, concordia university wisconsin; b.s., 1994, butler university, and certified immunizing pharmacist, apha. the author would like to thank the following for their mentoring assistance on this project: prof. joseph l. fink iii, bspharm., j.d., michael mcmains, r.ph., esq., and pro£ missy blue, r.ph, esq. this note received the 2011 indiana state bar association health law section's distinguished writ­ ing award. 188 indiana health law review [vol. 9:1 i. introduction the u.s. health care system is broken. the percentage of the unin­ sured has grown in the united states from 15.6 percent in 20031 to 16.7 percent in 200<y. the number one cause of bankruptcy in the united states, over sixty percent of all bankruptcies in 2007, was medical debt.3 accord­ ing to the world health organization's rankings of global health care sys­ tems, the u.s. health care system is thirty-seventh overall in terms of performance, while at the same time, it also is the most expensive health care system in the entire world.4 in 2005, researchers calculated that nearly 45,000 americans aged eighteen to sixty-four died due to a lack of health care insurance. 5 the total health care expenditure relative to total gross domestic product ("gdp," or $14.3 trillion6), according to the centers for medicare and medicaid services ("cms") in 2009, was 17.3%, up 1.1% from the previous year, and the highest annual increase since the year 1960.7 furthermore, the coming tsunami of baby boomers becoming senior citizens will double the elderly population by 2030, known as the "2030 problem,''8 and the country is also potentially facing a 150,000-physician shortage by 2025.9 the american academy offamily physicians reports a fifty percent decline in the past decade of medical students entering primary care.10 all this seemingly adds up to a daunting environment for americans 1. cannen denavas-walt et al., u.s. census bureau, income, poverty, and health insurance coverage in the united states: 2003, at 16 (2004), available at http://www.census.gov/prod/2004pubs/p60-226.pdf. 2. press release, u.s. census bureau, income, poverty and health insurance cover­ age in the united states: 2009 (sept. 16, 2010), available at http://www.census.gov /newsroom/releases/archives/income_ wealth/cb 1 0-144.html. 3. david u. himmelstein et al., medical bankruptcy in the united states, 2007: results of a national study, 122 am. j. med., 741, 741 (2009). 4. press release, world health organization, world health organization assesses the world's health systems (june 21, 2000), available at http://www.who.int/whr/2000/ media_ centre/press _release/en/. see also sue stock, pharmacists embrace expanding med­ ical role, standard-examiner, oct. 27, 2010, at 2, http://www.standard.net/topics /medical/20 l 0/10/27 /phannacies-embrace-expanding-medical-role ("a 2007 study from the new england healthcare institute estimated that 13 percent of total health care expenditures more than $290 billion a year arise because people don't take medications as pre­ scribed."). 5. andrew w. wilper et al., health insurance and mortality in u.s. adults, 99 am. j. pub. health 2289, 2292 (2009). 6. cia, 1he world factbook, https://www.cia.gov/library/publications/the-world­ factbook/geos/us.html (last modified nov. 17, 2011). 7. christopher j. truffer et al., health spending projections through 2019: the recession's impact continues, 29 health aff. 522, 522 (2010). 8. james r. knickman & emily k. snell, the 2030 problem: caring for aging baby boomers, 37 health servs. res. 849, 849 (2002). 9. suzanne sataline & shirley s. wang, medical schools can't keep up, wall st. j. (apr. 12, 2010), http://online.wsj.com/article/sb10001424052702304506904575180331 528424238.html. 10. press release, american academy of family physicians, fewer medical students 2012] pharmacists as legal health care providers 189 seeking primary care. however, problems are often disguised as opportunities. one bright spot of hope for health care is that of the profession of pharmacy. in 2009, the gallup organization's annual honesty and ethics poll found pharmacists the second most highly trusted professionals ( 66% ), only behind nurses (83% ). 11 also, pharmacists are the easiest professionals to access within the health care system.12 currently, there are 268,030 pharmacists in the unit­ ed states, 13 and the sole degree for entry as of 2004 is a minimum six-year doctor of pharmacy (pharm.d.) degree.14 pharmacists also have the options of residencies15 after their formal educational training, therapeutic specialty board certifications, 16 and certificates in providing immunizations, 11 medi­ cation therapy management,18 diabetes education/9 and asthma education.20 choose family medicine in 2009 match (mar. 19, 2009), available at http://www.aafp.orglonline/en/home/publications/news/news-now/resident-student­ focus/20090319match.html. see also nat'l ass'n of chain drug stores, pharmacies: improving health, reducing costs (20 1 0), http://www.nacds.org/user-assets/pdfs/20 11/ principlesothealthcare.pdf. 11. lydia saad, honesty and ethics poll finds congress' image tarnished, gallup (dec. 9, 2009), http://www.gallup.com/poll/124625/honesty-ethics-poll-finds-congress­ image-tarnished.aspx. 12. nat'l ass'n of chain drug stores, supra note 10. see also barry l. carter & william j. elliott, editorial, the role of pharmacists in the detection, management, and control of hypertension: a national call to action, 20 pharmacotherapy 119, 120 (2000) ("the public visits a community pharmacy nearly once a month-more than any other health care facility."). 13. u.s. bureau of lab. statistics, occupation emp't & wages, may 2010:291051 pharmacists, table 1, available at http://www .bls.gov/oes/current/oes291 051.htrn. 14. accreditation council for pharmacy enuc., accreditation standards and guidelines for the professional progmm in pharmacy leading to the doctor of pharmacy degree: preamble (adopted: jan. 15, 2006), available at http://www.acpe­ accredit.org/pdf/acpe_revised_pharmd_standards_adopted_jan152006.pdf. see also jennifer m. patton et al., am lost page: the doctor of pharmacy (pharmd) degree, 85 acad. mbd. 566, 566 (2010) (some schools require three pre-professional years before the four-year professional program, and forty-three percent of students entering the professional phase of pharmacy programs already earned a baccalaureate degree.). 15. directory of residencies, fellowships, and graduate programs, am. coll. of clinical pharmacy, http://www.accp.com/resandfev (last visited sept. 19, 2011 ). 16. current specialties, bo. of pharmacy specialties, http://www.bpsweb.org/ specialties/specialties.cfm (last visited dec. 20, 2011 ). 17. pharmacy-based immunization delivery, am. pharmacists ass'n, http$://www. pharmacist. com/ am/template.cfin?section=pharmacy _based_ immunization_ delivery (last visited dec. 20, 2011). 18. training in medication therapy management, am. pharmacists ass'n, http://www.pharmacist.com/ am/template.cfm?section=medication_ therapy_management _services_mtms_ (last visited dec. 19, 2011). see also mi'm central, am. pharmacists ass'n, http://www.pharmacist.com/am/temp1ate.cfin?section=mtm#nogo (medication therapy management (mtm) has been a service defined as the following, "as defined in a consensus definition adopted by the pharmacy profession in 2004, medication therapy man­ agement is a service or group of services that optimize therapeutic outcomes for individual patients. medication therapy management services include medication therapy reviews, phannacotherapy consults, anticoagulation management, immunizations, health and wellness programs and many other clinical services. pharmacists provide medication therapy man­ agement to help patients get the best benefits from their medications by actively managing 190 indiana health law review [vol. 9:1 "as a result of the evolution in pharmacy education, pharmacists are now trained with a focus and level of expertise in medication therapy manage­ ment that exceeds any _other health care provider's."21 furthermore, ''the focus of the profession [of pharmacy] has shifted from quietly dispensing medications to patient-focused practice in which pharmacists discuss with patients how to take their medications, help with medication selection, monitor therapeutic effects and drug-related outcomes, and make medication adjustments."22 yet, in the eyes of the law, both at the federal and indiana state levels, pharmacists are not legally "providers" of health care. under title xviii of the social security act, pharmacists are not included as health care "pro­ viders.'.23 health care providers are also defined under state law. in indi­ ana, pharmacists are not considered health care providers under the indiana medical malpractice act.24 although the scope of practice for the pharma­ cist has potentially widened with the advent of congress passing the patient protection and affordable care act ("ppaca") of 201025 along with the health care education and reconciliation act ("hcera") of 2010/6 the lack of provider status presents several challenges in delivering patient care by pharmacists-namely billing and liability issues. the objectives of this note are to present evidence and ultimately aver that it is time for pharmacists to be legally considered health care providers both at the federal level under the social security act and at the state level under the indiana medical malpractice act. the frrst section provides a background on the current state of pharmacy-including the challenges as­ sociated with pharmacists having no provider_status, and the history of what has been done to date regarding gaining provider status in other professions, such as nurse practitioners .. the second section provides a framework for how pharmacists are in fact already providing health care through programs such as administration of immunizations, providing medication therapy management {mtm), participating in the medical home, and leading emer­ gency preparedness programs. the third section will discuss the pros and drug therapy and by identifying, preventing and resolving medication-related problems."). i9. eligibility requirements, nat'l certification bd. for diabetes educators http://www.ncbde.org/eligibility.cfm (last visited sept. 19, 20 ii). 20. nat'l asthma educator certification bd., http:/lwww.naecb.org/ (last visited sept. i9, 2011). 21. jon c. schommer et al., pharmacist contributions to the u.s. health care sys­ tem, 1 innovations in pharmacy 1, 2 (2010), citing james a. owen & anne burns, the pharmacist in public health: education, applications, and opportunities (2010). 22. marie a. chisholm-burns et al., pharmacy management, leadership, marketing, and finance 50 (marie a. chisholm-bums et al. eds., 1st ed. 2011). 23. 42 u.s.c. § 1395 (2011). 24. ind. code§ 34-18-2-14 (2011). 25. patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 through 1025 (2010). 26. health care and education reconciliation act of 2010, pub. l. no. 111-152, 124 stat. 1029 through 1084 (2010). 2012] pharmacists as legal health care providers 191 cons of achieving provider status as phannacists and will explore different stakeholder interests and positions of pharmacists increasing their scope of care. ii. background a. the state of pharmacy without provider status pharmacists without legal provider status are presented with two equally precarious issues: (1) a lack of priority in reimbursement from third party payers for selling their products and services and (2) increased poten­ tial risk of liability while not possessing provider status under the indiana medical malpractice act. the first problem is best demonstrated by a re­ cent true story of tom miller, an dlinois independent pharmacist and phar­ macy owner of miller's phannacy in rural marion, illinois.27 on july 19, 2010, mr. miller not only had to close his pharmacy, but he also had to file bankruptcy for his pharmacy business.28 he also may have to file bankrupt­ cy personally because he took out personal loans for the business to keep the pharmacy running. 29 while a notable recession is occurring in dlinois and around the country, the reason for mr. miller's demise was courtesy of the state of illinois reimbursing him as a third party payer for his medicaid patients?0 because the majority of mr. miller's patients were medicaid recipients, he relied upon the state to reimburse him in a timely fashion­ ideally within forty-five days.31 however, his payments were taking much longer to arrive. in fact, the state oflllinois takes an average of 153 days to reimburse pharmacists. 32 "while the stimulus package33 requires states to pay other health care providers quickly, it has no such protections for phar­ macies. "34 as a result, independent and other rural pharinacies like mr. miller's who have a large medicaid patient population are either closing their doors and laying off their employees, or worse for patients, no longer accepting patients who have medicaid as their third party insurance payer.35 this is an example of the problem for pharmacists who do not have provid­ er status and the damage it can do to pharmacists and their patients. this story represents the plight of the phannacist when billing and suf27. daniel c. vock, in illinois, late payments fray the safety net, stateline (oct. 19, 201 0), http://www.stateline.org/live/details/story?contentld=521562. 28. id. 29. !d. 30. id 31. id. 32. id 33. american recovery and reinvestment act of 2009, pub. l. no. 111-5, 123 stat. 115 (2010). 34. vock, supra note 27. 35. id 192 indiana health law review [vol. 9:1 fering from a lack of status as a legal health care provider. while the medi­ care prescription drug, improvement, and modernization act of 200336 provided pharmacists the opportunity for the first time ever to bill for med­ ication therapy management services, by providing independent billing codes (named current procedural technology or cpt codes) to perform clinical medication therapy review services under medicare part d, insur­ ance companies and third party payers, including the federal government, nonetheless rely upon the provider status definition of medicare part b to discern who can be paid directly for their services (legal providers), and who is paid indirectly. incident to physician providers (not legal provid­ ers).37 pharmacists struggle to bill for their services directly and inde­ pendently. says one indiana clinical pharmacist, "this limited billing ability prevents pharmacists from being hired at physician offices, since they ·cannot earn their salary with reimbursement from patient services alone. "38 therefore, while the federal government has opened the door to pharmacists being potentially reinibursed for providing cognitive services, the lack of legal provider status limits the methods and levels of reim­ bursement. "a major priority ... is to foster expanded patient access to the clinical services of pharmacists. one of the most important tactics for achieving this objective is to obtain, incrementally, payer-specific provider status for pharmacists."39 pharmacists currently do not have independent, legal provider status; provider status is critical to obtain, because status is also linked to reimbursement and payment. the second major challenge for pharmacists, after billing and reim­ bursement in indiana, is ihat of a lack of protection for pharmacists as pro­ viders under the indiana medical malpractice act. indiana code section 34-18-2-14, or the medical malpractice act of 1975, was established to de­ crease "exposure to malpractice claims and lessen the alleged difficulty of obtaining malpractice insurance" for health care providers.40 in kroger co. v. estate· of hinders, the indiana court of appeals held that pharmacists were not providers in indiana, and furthermore, ''the [indiana medical mal­ practice statutes] clearly do not protect pharmacists and pharmacies.'.41 36. pub. l. no. 108-173, 117 stat 2066 (2003). 37. am. pharmacists ass'n, bll.ling for mtm services: tips for pharmacists (2008), available at http://www.phannacist.com/am!femplateredirectcfm?template=/cm/ contentdisplay.cfm&contentiif24120. 38. e-mail from emily papineau, assistant professor ofpharmacy, butler university, to erin albert, assistant professor of pharmacy, butler university (july 26, 2010, 04:07 est) (on file with author). 39. lisa daigle & david chen, ashp policy analysis: pharmacist provider status in 11 state health programs, am. soc'y healrn-svs. pharmacists (2008), available at http://www.ashp.org/doclibrary/advocacy/provideistatusprograms.asp. 40. kroger co. v. estate of hinders. 773 n.e.2d 303, 307 (ind. ct. app. 2002). see also winona mem. found. v. lomax, 465 n.e.2d 731 (ind. ct. app. 1984); see also warrick hosp. v. wallace, 435 n.e.2d 263 (ind. ct. app. 1982). 41. kroger co., 773 n.e.2d at 307. 2012] pharmacists as legal health care providers 193 lastly, under indiana code section 34-11-2-3, there is a two-year statute of limitations for tort claims against ''physicians, dentists, surgeons, hospitals, sanitariums, or others.'.42 however, the kroger court stated that this law did not apply because pharmacists are not included in this definition, nor are they included as ''others . ..4j thus, the second challenge in lack of pro­ vider status in indiana opens the pharmacist up to potentially wider liability because pharmacists have no protection under the indiana medical mal­ practice act. other states have also concluded that pharmacies are not cov­ ered under similar medical professional liability acts. for example, in phillips v. larry's drive-in pharmacy, inc., the west virginia supreme court overturned the lower circuit court's holding that a pharmacy was in­ cluded as a health care provider44 under the west virginia medical profes­ sional liability act;45 thus, the limits enjoyed by health care providers under the act were not included for pharmacies. b. legislative history and the scope of pharmacy practice expanding because of these challenges, and as the scope of the practice of phar­ macy has evolved, so has the movement to gain legal provider status among the profession. in the 1960s, the role of the clinical pharmacist, particularly in hospitals, became the genesis of clinical practice.46 in 1976, the board of pharmaceutical specialties ("bps") was established to recognize and de­ velop board certifications for pharmacists.47 during 1988, eighty percent of state statutes contained some· form of definition of pharmacy practice. 48 in 1990, the federal omnibus budget reconciliation act49 was passed, requir­ ing pharmacists to counsel patients and perf-orm drug utilization review ("our"), a review of all of a patient's medications. 5° also, the national association of boards of pharmacy (''nabp") developed a model state pharmacy act, along with model rules, including a definition of the prac­ tice of pharmacy, which is the following: the "practice of pharmacy" means the interpretation, 42. ind. code§ 34-ll-2-3 (2010). 43. kroger co., 773 n.e.2d at 308. 44. phillips v. larry's drive-in pharmacy, inc., 647 s.e.2d 920 (2007). see also joseph l. fink ill, is a pharmacy a .. health care provider"?, pharmacy times, dec. 2007, at46. 45. w.va. code§§ 55-7b-2-(g)(20ll). 46. henri r. manasse, jr. & marilyn k. speedie, pharmacists, pharmaceuticals, and policy issues shaping the work force in pharmacy, 64 am. j. healrn-sys. pharmacists e30, e33 (2007). 47. johanna l. keely, position paper: pharmacist scope of practice, 136 ann. intern. med. 79 (2002). 48. manasse, jr. & speedie, supra note 46, at e34. 49. pub. l. no. 101-508, 104 stat. 1388 (2010). 50. manasse, jr. & speedie, supra note 46, at e34. 194 indiana health law review evaluation, and implementation of medical orders; the dispensing of prescription drug orders; participa­ tion in drug and device selection; drug administra­ tion; drug utilization review (dur); the practice of telepharmacy within and across state lines; drug or drug-related research; the provision of patient coun­ seling; the provision of those acts or services neces­ sary to provide pharmacist care in all areas of patient care, including primary care, medication therapy management, collaborative pharmacy practice, the ordering, conducting, and interpretation of appropri­ ate tests, and the recommendation and administration of immunizations; and the responsibility for com­ pounding and labeling of drugs and devices . . . , proper and safe storage of drugs and devices, and maintenance of required records. 51 [vol. 9:1 two key watershed events occurred in 1994 relative to pharmacists and administration of immunizations: (1) secretary donna shalala of the u.s. department of health and hwnan services ("hhs") asked the ameri­ can pharmacists association ("apha") to develop the role of pharmacy in immunizations for children,52 and (2) the washington state pharmacy as­ sociation teamed up with georgia pharmacist, entrepreneur, and pioneer of providing vaccines in community practice, michael reagan, to provide the first organized vaccine administration training program for pharmacists in seattle.53 in 1995, two pharmacists went to local physicians in washington state and contracted into collaborative practice agreements ("cpas") in order to administer influenza vaccines. 54 in 2001, two pharmacist organiza­ tions (the american society of health-system pharmacists ("ashp") and the american college of clinical pharmacy ("accp")) joined forces to work on the provider movement,55 and in 2002, a group of pharmacy organ­ izations formed the pharmacist provider coalition, with the "goal of achiev51. nat'l ass'n of bds. of pharmacy, model state pharmacy act and model rules of the national association of boards of pharmacy § 104 (august 2011), available at http://www.nabp.net/publications/assets/modelact.doc. 52. michael d. hogue et al., pharmacist involvement with immunizations: a decade of professional advancement, 46 j. am. pharmacists ass'n 168, 169 (2006). 53. /d. at 170. 54. id. at 169. see also l.a. ferro et al., collaborative practice agreements between pharmacists and physicians, 38 j. am. pharmacists ass'n 655, 655 (1998) (a collaborative practice agreement between pharmacists and physicians "enable[ s] pharmacists to monitor and manage a patient's drug therapy, usually within the parameters of an agreed-upon treat­ ment protocol."). 55. press release, medscape today, provider status for pharmacists needed, alliance says, medscape medical news (apr. 5, 2001), available at http://www.medscape.com/viewarticle/411270. 2012] pharmacists as legal health care providers 195 ing recognition and payment for pharmacist services under part b of the medicare program."56 in 2003, the medicare prescription drug, improve­ ment, and modernization acr7 ("mma") was passed by congress to add a drug benefit to medicare recipients, medicare part d.58 unfortunately, while mma did provide pharmacists the codes to bill for cognitive ser­ vices, it did not recognize pharmacists as legal providers of health care un­ der part b. representative richard burr of north carolina introduced the medicare clinical pharmacist practitioner services coverage act of 2004;59 however, it never passed.60 the american recovery and reinvestment act of 2009 included in title xxx under health information technology and quality, included pharmacists and pharmacies as health care providers.61 in 2010, the patient protection and affordable care act passed, and it encour­ aged primary care practice in the form of medical homes, and the independ­ ence at home medical practice included physicians, nurses, physician assistants and pharmacists, among others, to provide home-based primary care services. 62 the movement forward towards pharmacists as providers under the social security act has been decades in .the making; however, it remains elusive. provider status is important, as it is the standard by which insurance carriers and third parties identify as professionals who can be re­ imbursed directly at the federal level and who can be protected by malprac­ tice limits from tort actions under medical malpractice acts at the state level. c. possible model for pharmacists to obtain provider status: the nurse practitioner the elusive provider status has been achieved by other professions, namely nursing. nurse practitioners gained provider status under the bal­ anced budget act of 1997,63 but this did not come overnight; it took several decades of diligence, evolution of the profession, and lobbying before pro­ vider status became a reality; [t]he key strategies that contributed to this victory were (1) gaining recognition that nursing had the po­ tential to expand its role, (2) documenting nurse prac56. manasse, jr. & speedie, supra note 46, at e35. 57. pub. l. no. 101-508, 104 stat 1388 (2010). 58. ctr. for medicare & medicaid servs. (cms), overview: prescription drug coverage general information, available at http://www.cms.gov/prescriptiondrug covgenln/01_0verview.asp. 59. h.r. 4724, 108th cong. (2004). 60. manasse, jr. & speedie, supra note 46, at e35. 61. american recovery and reinvestment act of2009, pub. l. no. 111-5 (2009). 62. patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 through 1025 (2010) (emphasis added). 63. balanced budget act of 1997. pub. l. 105-33, 111 stat. 296. 196 indiana health law review titioners value, {3) establishing standards in education and credentialing, {4) using professional organizations to empower individuals, and { 5) being willing to ac­ cept small, incremental gains over time. 64 [vol. 9:1 the first nurse practitioner training program began in 1965, due to the shortage of physicians and primary care services.6s despite pushback from physician groups, the nurse practitioners supported their role with evidence­ based medicine, research, publications, and cost-effective delivery of pri­ mary care. 66 voluntary certifications then evolved for the nurse practition­ er, along with advanced education.67 in 1977, the rural health clinic act gave some nurse practitioners reimbursement if they were serving rural are­ as, and it mandated fifty percent of funded rural health services be provided "by nurse practitioners, certified nurse-midwives, and physician assis­ tants.'.68 this practice settings' data was then leveraged to demonstrate to managed care and third party payers that the services were cost effective; but then the nurse practitioners realized that they would need to begin an aggressive lobbying campaign, which would last for twenty years, in order to gain provider status. 69 they encouraged and had nurses in key policy and fellowship positions in order to increase their presence on capitol hill, established positions on a physician payment review committee, and trained nurses to communicate with policyand law-makers as health care professionals.70 this work culminated in a leadership summit in 1993 and a published position statement, along with formation of the national nurse practitioner coalition {''nnpc"), a lobbying group. 71 this lobbying group morphed into the american college of nurse practitioners {"acnp"), and acnp members barraged their federal representatives with "calls, faxes, e­ mails that applied the pressure on congress to get the job done."72 64. john m. o'brien. how nurse practitioners obtained provider status: lessons for pharmacists, 60 am. j. liealm-svs. pharmacists i, i (2003), available at http://www. medscape.com/viewarticle/464663 _print 65. id at2. 66. id 67. id. 68. id. at 3-4. see also rural health clinic act of 1977, pub. l. no. 95-210. 69. o'brien, supra note 64, at 3. 70. id at5. 71. id. at2. 72. press release, american college of nurse practitioners, nurse practitioners vic­ torious in budget bill, acnp grassroots effort pays off (aug. 13, 1997), available at http://www.acnpweb.org/i4a/pages(mdex.cfin?pageid=3357. 2012] pharmacists as legal health care providers 197 ill. analysis a. pharmacists are already providing health care in reality, pharmacists are in fact already providers of health care. through the evolution of the education of a pharmacist from a four-year professional degree to a rigorous six-year doctor of pharmacy degree), to residencies, board certifications, and therapeutic and professional continu­ ing professional development certifications, pharmacists have been widen­ ing their scope of practice in order to meet the challenges of primary care, immunizations, public health, rural health, and indigent population health by stepping up to the plate and providing services to these professional are­ as and populations. there are four general areas to be explored relative to pharmacists providing health care in the united states that support and demonstrate the need for provider status of pharmacists: administration of immunizations; providing medication therapy management ("mtm"); sup­ porting and practicing within the medical home as part of the health care provider team, and with that, contracting with physicians under collabora­ tive practice agreements; and providing health care when and if disaster strikes under emergency preparedness. 1. provision of immunizations on average, 36,000 people die needlessly from influenza complica­ tions or the seasonal flu each year; of those, ninety percent are people aged sixty-five and older.73 in adults, diseases such as tetanus, diphtheria, per­ tussis, measles, mumps, rubella, varicella, pneumococcal diseases, hepa­ titis a and b, meningococcal diseases, herpes zoster, and human papillomavirus ("hpv") can all be prevented with vaccines (also known as vaccine-preventable diseases, or "vpds").74 the u.s. adult immunization schedule strongly suggests fourteen vaccinations for adults against infec­ tious diseases. 75 while childhood immunizations are at all-time highs, the opposite is true of adult immunizations, with only seventy percent of adults 73. nat'l found. for infectious diseases, facts about adult immunization, available at http://www.nfid.orglpdf/factsheets/adultfact.pdf. 74. karen k. o'brien, pharmacists' role in preventing vaccine-preventable diseas­ es, 34 u.s. pharmacist 39 (2009), available at http://www.uspharmacist.com/content/d/ feature/i/783/c/1450l/. see also ctrs. for disease control & prevention, advisory committee on immunization practices (acip), recommendations, available at http://www .cdc.gov/vaccineslrecs/acip/default.htm. 75. the nat'l found. for infectious diseases, national survey on adult vaccination reports low consumer awareness of vaccines and tile risks of vaccine-preventable diseases, available at http://www.nfid.org/pdf/factsheets /survey.pd£ 198 indiana health law review [vol. 9:1 obtaining the influenza vaccination.76 barriers to receiving a vaccine in a survey by the national foundation for infectious diseases included adults reporting being too busy to get a vaccine (13%), believing vaccines do not work (14%), reporting they would not obtain a vaccine because they had to pay for it (22% ), reporting vaccines are too expensive to obtain (26% ), and reporting that vaccines are not safe (35%).77 furthermore, there are signifi­ cant costs-indirect and direct--associated with infectious disease. for example, a global resurgence of measles from 1989-91 occurred, "resulting in more than 55,000 cases, 11,000 hospitalizations, 120 deaths, and $100 million in direct medical care costs."78 since the first vaccination procedure in 1796 by edward jenner/9 pharmacists have been working with and supporting vaccination campaigns. pharmacists not only dispense vaccinations, but they can also educate in order to eradicate most if not all of the barriers that adult patients perceive with vaccinations. the expansion of pharmacists administering vaccines came in 1994 when. the first vaccination training program was offered to pharmacists.80 by 2008, over 30,000 pharmacists had been formally trained on how to administer vaccinations,81 and as of october 2010, the number of pharmacists who had completed the american pharmacists association cer­ tificate training program on pharmacy-based immunization delivery was 140,000,82 or over 60% of the 220,000 licensed pharmacists in the united states.83 pharmacists in all fifty states had some legal capacity to provide vaccinations as of september 12, 2009;84 although, there is wide variability as to whom pharmacists may vaccinate, such as adults, but not children, and under a prescription, under a protocol without, or all of the above.85 view­ ing the most recent pandemic, or potential pandemic-the 2009 hlnl in­ fluenza outbreak-writers of, the 2009 hjnj influenza vaccination 76. alan r. hinman and walter a. orenstein, adult immunization: what can we learn from the childhood immunization program?, 44 cu.nical infectious diseases 1532, 1532, available at http://cid.oxfordjoumals.org/content/44/l2/1532.full. 77. the nat'l found. for infectious diseases, supra note 75, at 2. 78. ctrs. for disease control & prevention, healthy people 2010: 14: immunization and infections diseases, 1, 4, available at http://www.healthypeople.gov/ documentlhtrnl/volume l/14immunization.htm. 79. hogue et al., supra note 52, at 169. 80. /d. 81. o'brien, supra note 74, at 41. 82. e-mail from misty l. robling, certificate program coordinator, american phar­ macists association, to erin albert, assistant professor of pharmacy, butler university (oct. 28,2010, 10:41 est) (on file with author). 83. o'brien, supra note 74, at 41 (the percentage calculation in this sentence is based upon 220,000 licensed pharmacists in the u.s. the actual percentage is 63.63% as of oct. 28, 2010.). 84. kate traynor, with maine on board, pharmacists in all 50 states can vaccinate, am. soc'y health-sys. pharmacists (nov. l, 2009), http://www.ashp.org/menu!news/ pharmacynews/newsarticle.aspx?id=3199 (last visited oct. 30, 2010). 85. /d. see also o'brien, supra note 74, at 41. 2012] pharmacists as legal health care providers 199 campaign: summary of a workshop series, clare stroud and others, stated the following regarding pharmacies: many arguments can be given for the use of retail pharmacies in administering vaccine, but the most compelling is availability; large numbers of immuniz­ ers are ready and available to administer vaccine. for example, walgreens, as of the t4ne of the workshops, had trained 85 percent of its pharmacists as immuniz­ ers, with a goal to increase that to l 00. percent. pharmacies know their markets; they are in the com­ munity and have established relationships with local, state, and national public health. distribution net­ works are already in place and easily accessed by high-risk individuals. also, pharmacies are open dur­ ing evening, weekend, and holiday hours, when pub­ lic health clinics and doctors' offices may be closed. retail clinics located inside pharmacies also provided 2009 hlnl vaccinations .... opening up vaccina­ tion through retail pharmacies increases the number of access points the population has to receive vac­ cine.86 the story of patti veliotes is a final, real-world example of why pharmacists are immunizing patients, preventing illness, and already providing health care.87 patti, a seventy-six-year-old woman, had friends who were getting shingles, and she wanted to get an immunization to pre­ vent shingles in herself. 88 she went to her doctor to obtain one, but her doc­ tor did not have the vaccine in his office.89 why? two reasons: (1) the shingles vaccine must be stored frozen, and (2) because, "increasingly, doc­ tors are opting not to provide these vaccines because reimbursement from private insurance and medicare is often inadequate."90 dr. kenneth schmader, chief of geriatric medicme at duke university medical school, goes on to state in regard to pharmacists providing immunizations the fol­ lowing: "i think it's a good idea from a public health perspective .... we try to remove as many barriers as we can to vaccination; having as many 86. clare stroud et al., the 2009 hlnl infwenza vaccination campaign: summary of a workshop series 44-45 (2009), available at http://www.nap.edu/catalog/ 12992.html. 87. patti neighmond, many pharmacists now administer vaccinations, nat'l pub. radio (oct. 18, 2007), http://www.npr.orgltemplates/story/story.php?storyld=15380907. 88. ld. 89. id 90. id 200 indiana health law review [vol. 9:1 providers as possible to give a vaccine is a good thing, and that includes pharmacists."91 if doctors who are legal providers of health care opt out of offering their patients health care in the form of immunizations, who will step up and offer them instead? pharmacists. if pharmacists are willing to provide this care, they should be legal providers as well, and should be re­ imbursed at levels of other legal providers of health care. 2. medication therapy management (ml'm) under mma of 2003, ppaca of 2010, and hcera of 2010, phar­ macists are given larger opportunities and potential responsibilities to per­ form drug optimization management in the form of medication therapy management, or mtm. mtm is: as defined in a consensus definition adopted by the pharmacy profession in 2004, medication therapy management is a service or group of services that op­ timize therapeutic outcomes for individual patients. medication therapy management services include mediation therapy reviews, pharmacotherapy con­ sults, anticoagulation management, immunizations, health and wellness programs and many other clini­ cal services. pharmacists provide medication therapy management to help patients get the best benefits from their medications by actively managing drug therapy and by identifying, preventing and resolving medication-related problems. 92 through the mma of 2003, cms required each health insurance company providing medicare part d plans with drug coverage to also pro­ vide mtm services for eligible patients,93 which must include the ability to "optimize therapeutic outcomes through improved medication use and re­ duce the risk of adverse events, including adverse drug reactions."94 while other health care providers could deliver these services, only pharmacists 9l. /d. (emphasis added). 92. am. pharmacists ass 'n, supra note 18. 93. djenane ramalho de oliveira et al., medication therapy management: 10 years of experience in a large integrated health care system, 16 j. managed care pharmacy 185, 186 (2010), available at http://www.cms.gov/prescriptiondrugcovcontra/082_mtm.asp (quoting medicare part d medication therapy management (ml'm) programs, ctrs. for medicare and medicaid servs. (2010), available at http://www.cms.gov/prescription drugcovcontra/082 _ mtm.asp ). 94. /d. (quoting medicare part d medication therapy management (ml'm) pro­ grams, ctrs. for medicare and medicaid servs. (2010), available at http:// www.cms.gov/prescriptiondrugcovcontra/082 _ mtm.asp ). 2012] pharmacists as legal health care providers 201 were specifically mentioned as providers of these services.95 mtm services can also vary from pharmacy to pharmacy, can be targeted for specific dis­ ease management states, such as diabetes, and can be described as pharma­ ceutical care,96 and can include even brown bag sessions, where patients bring all of their medications to one pharmacist for review live or telephon­ ically.97 providing this service allows a pharmacy to expand its pharma­ cists' scope of practice and "to be reimbursed for direct patient care services."98 however, pharmacists were already previously providing vari­ ous forms ofmtm services prior to mma 2003. the classic mtm exper­ iment, and one of the first to the pharmacy world, occurred in asheville, north carolina, and is otherwise know as the asheville project. the ashe­ ville project was a collaborative mtm program dealing with two specific disease states-diabetes mellitus99 and asthma. 100 this was a collaborative project for the employees of the city of asheville. asheville was a self­ insured entity, covering 1030 patients within its plan. 101 the city identified sixty city employees or dependents who suffered from diabetes.102 to those diabetic patients, the city offered an opportunity: if they would agree to see a pharmacist to learn how to better manage their disease, they would re­ ceive a waiver of their co-pays on drugs and supplies for monitoring diabe­ tes as an extra incentive to enroll in this project. 103 furthermore, the city of asheville paid pharmacists for their time while consulting these patients­ $75 for an initial consultation, $45-65 for intermediate assessments lasting 30-45 minutes, and $20 for follow-up visits. 104 the total cost of the pro­ gram, including compensation for the pharmacists, was around $14,000 for the city. 105 the director of risk management for the city saw positive out­ comes as early as six months into the program.106 patients were taking bet95. id. 96. id. 97. see generally alan nathan et al., 'brown bag' medication reviews as a means of optimizing patients' use of medication and of identifying potential clinical problems, 16 fam. prac. 278 (1999). 98. ramalho de oliveira et al., supra note 93. 99. daniel g. garrett, the answer to how is when: the genesis of the asheville pro­ ject, pharmacy times, oct. 1998, at 4, available at http://www.pharmacytimes.com/files/ articlefilesffheashevilleproject.pdf. 100. barry a. bunting & carole w. cranor, the asheville project: long-term clini­ cal, humanistic and economic outcomes of a community-based medication therapy man­ agement program for asthma, 46 j. am. pharmacists ass'n 133 (2006). 101. john miall, jr., an investment in health offers a high return for all, pharmacy times, oct. 1998, at 28, available at http://www.pharmacytimes.com/files/articlefiles! theashevilleproject.pdf. 102. id. 103. id. 104. id. at 29. 105. id. 106. id. 202 indiana health law review [vol. 9:1 ter care of themselves, according to the plan nurse.107 the primary meas­ urement, control of hemoglobin ai c for diabetic patients, showed that eighty-five percent of the patient population in the program at fourteen months had at least some improvement. 108 also, insurance claims on inpa­ tient and outpatient services decreased by $20,246 during the one-year treatment period, despite compensating pharmacists for their time in provid­ ing cognitive services.109 said one endocrinologist of the program: a chronic illness like diabetes requires a lot of self­ management. pharmacists educated and trained to assist in the management of that specific health prob­ lem can make a difference by monitoring people with diabetes and encouraging them to follow through on self-care and with other providers .... this type of program works best as a team effort, with primary care physicians, endocrinologists, pharmacists, educa­ tors, case managers, data managers, and hospital ad­ ministrators working together.110 an asthma program yielded similar positive results as part of the asheville project.111 therapeutic outcomes in forced expiratory volumes ("fev 1 ") improved and were sustained, 99% of patients bad an asthma ac­ tion plan, emergency department visits decreased from nearly 10% to 1.3%, hospitalizations due to asthma decreased, and both indirect cost savings of $1230/patient/year and direct cost savings of $725/patient/year were real­ ized over the course of the 5-year study.112 interestingly, patients at base­ line who were seeing a primary care doctor bad a severity score of 3.3 on .a 4-point severity scale, and those seeing a specialist bad a baseline score of 3.0, but both groups improved their severity scores down to a 2.5, and both were statistically significant from baseline.113 this result demonstrates that pharmacist education and intervention, regardless of whether the patient was seeing a primary care provider or a specialist, provided a benefit to the patient through pharmaceutical care or mtm by the pharmacist. 107. id 108. carole w. cranor, outcomes of the asheville diabetes care project, pharmacy times, oct. 1998, at 19, 21, available at http://www.pbarmacytimes.com/fi1es/articlefi1es/ theashevilleproject.pdf. · 109. !d. at 19, 22. 110. paul martin, working together to improve patient care, pharmacy times, oct. 1998, at 26, available at http:/lwww.pbarmacytimes.com/files/articlefiles/theashevillepro­ ject.pdf. 111. bunting & cranor, supra note 100. 112. !d. 113. !d. at 138 (the authors of this paper did not state there was equal benefit relative to the outcome of the 4-point severity scale in this paper; they merely presented the data.). 2012) pharmacists as legal health care providers 203 there are other studies that demonstrate economic, therapeutic, and patient satisfaction and outcome data supporting the idea that what pharma­ cists do in mtm makes a significant difference in the lives of patients. the diabetes ten city challenge reduced total health care costs by $1079 per patient per year compared to projected costs using community-based phar­ macist disease state coaching. 114 hemoglobin al c had statistically signifi­ cant decreases for the managed patient population, along with statistically significant, clinically positive outcomes on decreasing ldl cholesterol and systolic blood pressure.115 influenza vaccination rates in the patient popula­ tion doubled, foot examinations more than doubled, and eye examinations increased from fifty-seven percent to eighty-one percent.116 pharmacists are already providing health care services through mtm. some of the challenges moving forward, while considering the former chal­ lenges faced by nurse practitioners gaining provider status, include the fol­ lowing for the profession of pharmacy to consider: (1) standardizing quality and consistency, through mtm certification and training programs; (2) harmonizing billing platforms and health care information technology (hit) standards; and (3) consistently demonstrating value---both clinical and economic~f mtm services to the public and other health care part­ ners. the american pharmacists association along with eighteen addition­ al organizations are already providing mtm certification programs as continuing professional development for pharmacists. 117 this allows for efficient and effective training standards for the profession relative to mtm. 118 second, there are currently thirty u.s. health care insurance plans that support pharmacists providing mtm services.119 several information technology platforms by which pharmacists may bill for mtm services also exist-outcomes, nexdose, medication pathfinder, medication manage­ ment systems, inc., community mtm, clinical support services, 120 and mirixa,121 to name a few. outcomes, one of the platforms, reported finding over one million medication therapy problems alone through its targeted 114. toni fera et al., diabetes ten city challenge: final economic and clinical results, 49 j. am. pharmacists ass'n 383, 383 (2009). 115. ld 116. /d. 117. harold n. godwin, president, am. pharmacists ass'n, inaugural speech at the annual meeting: setting the vision for a stronger tomorrow (mar. 14, 2000) (transcript available at http://www.pharmacist.com/ am!template.cfin?section=mtm&contentid= 23153&templa te=/cm/contentdisplay.cfin). 118. delivering medication therapy management services in the community, am. pharmacists ass 'n, http://www .pharmacist. com/ am!template.cfin?section =delivering_medication_therapy_management_in_the_community (last visited dec. 25, 2011). 119. godwin, supra note 117. 120. pharmacy marketplace, ml'm (medication therapy management), pharmacy choice, http://www.pharmacychoice.com/marketplace/category.cfinllisting/mtm medica­ tion_therapy_management (last visited sept. 19, 2011). 121. mirixa, http://www.mirixa.com/ (last visited sept. 19, 2011). 204 indiana health law review [vol. 9:1 intervention program ("tip®").122 during a 2008 consensus meeting of pharmacy leaders to discuss the future path of mtm, one of the strategies identified to take mtm into the future was to "enable billing that is con­ sistent among all payers and that is consistent with billing used by other health care providers."123 last but certainly not least, pharmacy as a profes­ sion, much like nursing, must keep consistently researching and reporting the value of mtm in the literature to support the value of the return on in­ vestment. the asheville project with diabetes124 and asthma,125 the diabe­ tes ten city challenge, 126 and the fairview ten-year dataset from minnesota, 127 are excellent examples of datasets demonstrating the clinical and economic value of pharmacists providing mtm services. over two million patients have accessed the benefits of mtm services thus far and have witnessed firsthand pharmacists providing health care services.128 furthermore, cms estimates that as many as onefourth of medicare part d drug prescription plan patients were eligible for mtm services in 2010, and cms is requiring part d plans. to expand.129 plans currently offering mtm are seeing as much as $4.73 for every dollar spent as the return on investment in mtm.130 also, even some patients with chronic conditions are willing to pay for mtm services; one study demonstrated that patients were willing to pay on average $17.57 for a mtm session.131 through the­ se continued three practices, there is no reason why lawmakers should not give pharmacists provider status at the federal and state levels, if the con­ tinued research, credentialing, and han.ilonization of mtm services contin­ ue. as said recently by an independent pharmacy owner: pharmacists have been filling and dispensing pre­ scription medications, counseling patients (free of charge), and advising in the use of over-the-counter 122. outcomes® detects one million drug therapy problems, business wire (oct. 27, 201 0), http://www. businesswire.com/news/home/20 10 l 027006938/en/outcomes%c2% ae-detects-million-drug-therapy-problems. 123. marsha k. millonig, mapping the route to medication therapy management documentation and billing standardization and interoperability within the health care system: meeting proceedings, 49 j. am. pharmacists ass 'n e41, e50 (2009). 124. miall, jr., supra note 101. 125. bunting & cranor, supra note 100. 126. fera et al., supra note 114. 127. ramalho de oliveira et al., supra note 93 (quoting ctrs. for medicare & medicaid servs., medicare part d medication therapy management (mtm) programs, available at http://www.cms.gov/prescriptiondrugcovcontra/downloads/ mtmfactsheet.pdf). 128. godwin, supra note 117. 129. renee frojo, as cms toughens mtm regs, plans demand more roi data, alshealtii.com (oct. 19, 2010), http://aishealth.com/archive/ndbn100810-03. 130. jd. 131. megan friedrich et al., patients ' needs and interests in a self-pay mediation therapy management service, 50 j. am. pharmacists ass'n 72 (2010). 2012] pharmacists as legal health care providers medications (free again) for years. however, it is the dispensing function that has been almost exclusively the main revenue generator for pharmacists . . . . we need to create and implement cognitive-based func­ tions into pharmacy practice that are viable and reim­ bursable. 132 205 some third-party health care insurers, like blue shield of california, see the value of mtm services and what a pharmacist can bring to the table for patients. said regarding mtm services by dr. andrew halpert, medical director at blue shield, "the pharmacists 'could do as well and better than a physician' for less money."133 3. the medical home and collaborative practice agreements although the concept of the medical home is not new to medicine, the concept of the addition of a pharmacist to the medical home team is a newer concept and increasingly of interest because of the medical home programs mandated by cms in the new health care legislation. the idea or concept of the medical home originated in pediatric medicine,134 where the ameri­ can academy of pediatrics described the model as "a central location for archiving a child's medical record,"135 which also involves coordinating patient care,136 in the form of"accessible, continuous, comprehensive, fami­ ly-centered, coordinated, compassionate, and culturally effective care. "137 the model utilizes a team-based approach to a patient's care, in ~articular for patients being treated for multiple health conditions, with physicians, nurses, pharmacists, social workers, dieticians, and other healthcare provid­ ers.138 pharmacists may be integrated into this model fu one of three ways-either by contracting with the physician's group, by charging for mtm services incident to prescription dispensing, or being hired as a full132. maria y01mg, partnering with pharmacists, pm360, sept. 2010, at 38, 39, avail­ ableathttp://www.pm360online.comlf1_0910 (last visited sept. 15, 2011). 133. reed abelson, pharmacists take larger role on health team, n.y. times, aug. 13,2010, http://www.nytimes.com/2010/08/14/health/14pharmacist.html?emc=etal. 134. charles j. homer et al., a review of the evidence for the medical home for chil­ dren with special health care needs, 122 pediatrics e922, e922 (2008), available at http://www.pediatrics.org/cgilcontent/ful1/122/4/e922. 135. lisa a. daigle & kristin banek, pharmacists' mi'm services key to health care homes' success, am. soc'y healm-sys. pharmacists 1, 2 (mar. 2009), www.ashp.org/ doclibrary/news/health_ care_home.pdf. 136. id. 137. ld. 138. jd; see also marie smith et al., why pharmacists belong in the medical home, 29 healm aff. 906, 906 (2010) ( .. [pharmacists] perform comprehensive therapy reviews of prescribed and self-care medications, resolve medication-related problems, optimize com­ plex regimens, design adherence programs, and recommend cost-effective therapies. phar­ macists should play key roles as team members in medical homes."). 206 indiana health law review [vol. 9:1 time employee by the practice.139 furthermore, pharmacists may contract with physicians under a "collaborative drug therapy management"140 ("cdtm") agreement in order to provide medication and health manage­ ment programs. as of 2008, forty-five states allowed cdtm between doc­ tors and pharmacists. 141 cdtm is authorized at the state level by state boards of pharmacy, and typically utilizes practice protocols, which may or may not allow pharmacists to modify a patient's therapies, order laboratory tests, educate, monitor, and assess therapeutic responses, and actually ad­ minister medication. 142 in indiana, cdtm is only allowed in the institu­ tional setting, such as the veterans health administration ("va") system, and the indian health services ("ihs"). 143 under ihs, a grant gave phar­ macists the opportunity to develop the pharmacist practitioner program, which allowed pharmacists to provide drug therapy management along with physicians, and demonstrated positive results.144 however, indiana is lag­ ging behind over thirty other states, where cdtm is allowed in a variety of settings, beyond acute care and mental health facilities.145 there exists "considerable evidence that clinical pharmacy interventions reduced the frequency of drug-related problems in the elderly."146 ·another private model of the medical home, geisinger health system, found that by aggres­ sively focusing on primary care and managing chronic diseases, the system realized 7% savings in costs and a "200/o reduction in hospital admis­ sions."147 however, while pharmacists have and continue to demonstrate their value in the medical home model, the increasing issue at hand is how pharmacists get paid for providing this health care.148 "[c]are in the outpa­ tient setting and after hospital ·discharge is paid on a fee-for-service basis, and visits to pharmacists are not reimbursed in most states. "149 it is difficult to justify hiring a pharmacist in a medical home without the ability to bill for and be reimbursed by insurance companies and medicare, without pro139. daigle & banek, supra note 135, at 3. 140. id. 141. am. pharmacists ass'n, issue brief: collaborative drug therapy management (mar. 2008), http://www.phannacist.com/am!femplateredirect.cfm?template=/cm /contentdisplay.cfm&contentid= 16882. 142. /d. 143. raymond w. hammond et al., accp position statement: collaborative drug therapy management by pharmacists-2003, 23 pharmacornerapy 1210, 1213 (2003), http:/ /www.pharmacotherapy.org/pd£'free/pharm2309 _ accp-thermgmt.pdf (it is interest­ ing to note that the federal food, drug and cosmetic act ("fdc") of 1938 and durham­ humphrey amendment of 1951 actually led to pharti:lacists being unable to prescribe drugs. prior to this legislation, pharmacists could prescribe.). 144. id 145. am. pharmacists ass'n, supra note 141. 146. david w. bates, role of pharmacists in the medical home, 66 am. j. healrnsvs. pharmacy 1116, 1116 (2009). . 147. /d.at1117. 148. /d.at1116. 149. /d. at 1117. 2012] pharmacists as legal health care providers 207 vider status. in june 2008, the medicare payment advisory commission's report to the congress, reforming the delivery system, suggested that pa­ tient medication reviews should be managed with a pharmacist.150 howev­ er, who will pay for providing these services if pharmacists do not have the ability to bill as providers of health care? indiana, during the 2011legislative session, bas introduced house bill no. 1111, which would expand collaborative practice from hospital settings to any setting where there exists a physician under protocol.151 this "drug therapy management" bill would allow fharmacists with physicians under protocol to adjust medication dosing.15 indiana, along with five other states-lllinois, north dakota, nevada, arizona, and new hampshire­ restricts drug therapy management practices.153 as ofthis writing, it is un­ known whether h.b. 1111 in indiana will receive a hearing by the house public health committee.154 currently, under indiana code section 25-2616-1, hospitals and health facilities can authorize pharmacists via protocol only to adjust drug regimens for patients.155 expanding collaborative prac­ tice from hospital-only settings between pharmacists and physicians to all potential practice settings would advance pharmacists in providing health care to patients and assisting with disease state management programs, in order to help keep rising health care costs from bankrupting the u.s. health care system. 4. emergency preparedness and response last, but certainly not least, pharmacists can get involved in disas­ ter/emergency preparedness and response teams. with the recent examples of natural disasters in haiti and chile internationally, hurricane katrina in the united states, and even the june 2008 flooding of mid-central and southern indiana, 156 pharmacists can play a pivotal role in satisfying the higher demand for primary care during natural disasters. as stated by a physician in the annals of internal medicine writing about response to dis­ aster with health care professional students, ''the need for primary care in­ creased for the many persons deprived of appropriate housing and living in 150. medicare payment advisory comm'n, report to the congress: reforming the delivery system (2008), available at http://www.medpac.gov/documents/ jun08_entirereport.pdf. see also daigle & kristin banek, supra note 135, at 1. 151. h.b. 1111,2011 gen. assemb. lst sess. (ind. 2011). 152. e-mail from mary andritz, dean, butler university college of pharmacy and health sciences, to erin albert, assistant professor, butler university (jan. 28, 2011, 01 :39 est) (on file with author). 153. !d. 154. id. 155. ind. code.§ 25-26-16-1 (2011). 156. eric r. riddle, watershed: service in thew ake of disaster. (1st ed. 2009) (this book chronicles the flooding in june, 2008, in columbus, indiana. in indiana during this flood, there were three disaster areas declared at the federal level.). 208 indiana healtii law review [vol. 9:1 dangerously unsanitary conditions due to the lack of drinking water, elec­ tricity, and safe food."157 internationally, ''pharmacists can contribute to ensure that the disaster victims have timely accessibility to medicinal supply in fulfilling their cur­ rent practice responsibilities as well as expanded roles of first responder, triage, immunization, and first aid administration."158 in the united states, some states are mandating that pharmacists have some specific continuing education in emergency preparedness;159 however, indiana does not yet have this requirement for pharmacists. pharmacists who volunteered in haiti described their work and chal­ lenges, including providing medications, dosing, finding alternative drugs when the first choice was not in stock, and determining drug dosing from medications unavailable in the united states, without assistance of tradi­ tional resources, such as the internet and/or computers.160 pharmacists also can be members of disaster medical assistance teams ("dmats"), and some who were u.s. dmat members went to haiti to help victims of the earthquake as well.161 the dmats in the united states are now being de­ ployed to natural disasters outside the united states.162 a dmat member and emergency room pharmacist in massachusetts, shannon manzi was deployed to haiti and creatively helped with optimizing use of materials, such as syringes, that were not needed for normal use (insulin syringes), but instead figured out how to use them in administering morphine subcutane­ ously.163 she also helped translate.french-made tetanus immune globulin for patients.164 she also responded to all "codes"165 at the facility in which she was deployed. pharmacists can currently work with or voluntarily sign up to serve dmats, their own state boards of pharmacy, metropolitan medical response systems ("mmrs")/66 or with the u.s. department of 157. humberto reyes, students' response to disaster: a lesson for health care pro­ fessional schools, 153 ann. internal men., 658,658 (2010). 158. int'l pharm. fed'n, fip statement of professional standards, the role of the pharmacist in crisis management: including manmade and natural disasters and pandem­ ics (aug. 2006), http://www.fip.org/www/uploads/database_file.php?id=275&table_id=. 159. the univ. of georgia coll. of pharm. continuing educ. & 0u1reach, http://www.rxugace.com/emergency (last visited feb. 14, 2011) (website outlines there­ quirement in georgia for pharmacists to complete at least 3 hours of continuing education in emergency p~ess.). 160. campbell pharmacy graduates volunteer in haiti field hospital, campbell univ., at 2 (may 24, 2010), http://www.campbell.edu/newslitem/campbell-pharmacy-graduates­ volunteer-in-haiti-field-hospital 161. cheryl a. thompson, pharmacist's out-of-the-box thinking helps haitian earthquake victims, am. soc'y healtii-sys. pharmacists (feb. 1, 2010), http:// www.ashp.org/menu/news/phannacynews/newsarticle.aspx?id=3266. 162. /d. at 1. 163. /d. at 2. 164. /d. 165. /d. at 3. 166. laurie l. briceland, pharmqcists and emergency preparedness, mm>scape 2012] pharmacists as legal health care providers 209 health and human services as part of the emergency system for advance registration of volunteer health professionals ("esar-vhp").167 also, after the tragedy of 9/11, pharmacy and public health leaders met to under­ stand the issues facing emergency preparedness relative to the pharmaceuti­ cal supply chain-yet another way to have pharmacists better manage disaster recovery and better manage drug shortages.168 emergency man­ agement and preparedness are yet another way that pharmacists can provide health care in times of need, and in particular, primary care, to patients who may not otherwise receive care. through these various organizations, pharmacists can and have volunteered their time and talent to patients in need and therefore are truly providing care already during natural and hu­ man disasters. b. pros and cons of pharmacists as legal health care providers all new ideas come with skepticism and controversy. there are ar­ guments against pharmacists becoming legal health care providers under the social security act federally, and at the state level, including indiana. there is also strong support of pharmacists as legal health care providers. both viewpoints are detailed below. 1. physicians' and professional organizations' opinions on pharma­ cists as legal health care providers there is resistance on the part of major physician professional socie­ ties for allowing other health care professionals to provide health care. the american academy of family physicians ("aafp") "believes that only licensed doctors of medicine, osteopathy, dentistry, and podiatry should have the statutory authority to prescribe drugs for human consumption"169 and "[p ]harmacists should not alter a prescription written by a physician, except in an integrated practice supervised by a physician or when permit­ ted by state law." however, aafp goes on to state in a position paper on pharmacists that in a collaborative setting, patients treated in a pharmacist-managed clinic had better anticoagulation control, fewer bleeding and. thrombotic complications, fewer hospitalizations and today (oct. 14, 2002), http://www.medscape.com/viewartic1e/442444. 167. u.s. dept. of health & human servs., the emergency system for advance registration of volunteer health professionals: about esar-vhp, faqs (2011), available at http://www.phe.gov/esarvhplpages/faqs.aspx. 168. summary of the executive session on emergency preparedness and the pharma­ ceutical supply chain, 59 am. j. health-sys. pharmacy 247 (2002). 169. drugs, prescribing aafp policies, am. acad. fam. physicians, http:// www.aafp.orglonline/enlhome/policy/policies/dlprescribing.html (last visited dec.· 28, 2011). 210 indiana health law review emergency room visits, and lower health care costs compared to newly anticoagulated patients treated in the standard manner. collaborative programs have demonstrated success in other areas, including hyper­ lipidemia, asthma, diabetes, and hypertension.170 [vol. 9:1 the american medical association ("ama") released the ama scope of practice data series: compendium on pharmacists in september 2009 to policymakers. 171 while the report was not yet publicly released, the doc­ ument was released to leaders of several pharmacy organizations. in a letter signed by leaders of the american pharmacists association, american as­ sociation of colleges of pharmacy, the american college of clinical phar­ macy and four other national pharmacy organizations dated aprill6, 2010 to dr. michael maves, ceo of the american medical association, pharma­ cy leaders voiced "serious concerns about the portrayal within the document of pharmacists' scope of practice, the provision of collaborative drug thera­ py management (cdtm) services, and the education and training of phar­ macists."172 the letter goes on to state, ''the suggestion in the document­ that the evolving scope of practice of pharmacists serves primarily to 'com­ pensate' for increased automation and utilization of pharmacy technicians­ is simply wrong."173 the drafters of the response letter suggested that the inaccuracies be corrected, and concluded that, "pharmacists are filling roles today that were largely unmet and that support the health care team in a pa­ tient centered model."174 interestingly, the ama scope of practice data series: pharmacists has yet to be released to the public. in response to the letter, president of the american pharmacists association, thomas menighan, responded in a follow-up publication that, we [pharmacists] continue to get "good press" from many nonpharmacist organizations that see the value of pharmacists as medication coaches in collaboration with other healthcare professionals and as part of the medical or health home. organizations such as aarp, the patient-centered primary care collabora­ tive, the joint commission, the association of aca­ demic health centers, and the institute of medicine 170. am. acad. f am. physicians, pharmacists (posidon paper) (2006), available at http://www.aafp.org/online/en/home/policy/policies/p/pharmacistspositionpaper.html. 171. ted agres, ama seeks limits to pharmacists· &ope of practice, 37 pharmacy prac. news 5 (may 2010), available at http://www.pharmacypracticenews.com niewarticle.aspx?d _id=51 &a _id= 15162. 172. letter from thomas e. menighan, pres. am. pharmacists ass'n et al. to michael d. maves, ceo, am. medical ass'n (apr. 16, 2010) (on file with author). 173. id 174. /d. 2012] pharmacists as legal healtb care providers have all recognized contributions that pharmacists can make on the healthcare team. 175 211 of course, another way to fix the primary care doctor shortage would be to offer more residencies and increase primary care providers' pay; how­ ever, "there's resistance to these steps because of their costs,"176 according to kaiser health news in a report on health bills in congress not fixing the primary care shortages. legislative attempts at expanding primary care training are not feasible because of a $10 billion price tag over ten years. 177 who, then, will fill the primary care void? 2. pharmacist professional societies and support of pharmacists as legal providers last, there are several organizations, both in and around pharmacy, that support the concept of pharmacists increasing their role on health care teams. donald berwick, physician and head of cms, "strongly agreed that meds are a critical issue and pharmacy is a critical player," at a public con­ ference on community-based care sponsored by cms.178 furthermore, aarp and walgreens partnered on the "aarp iw algreens wellness tour" to recently surpass their two millionth health screening.179 the tour began in april 2009 and health screenings have been free to patients in "more than 3,000 underserved communities throughout the united states and puerto rico."180 stated a. barry rand, ceo of aarp, of the tour, "these screen­ ings [cholesterol levels, blood pressure, bone density, glucose, waist cir­ cumference, and body mass index] by walgreens will go a long way in increasing the chances for early detection of chronic disease and other po­ tential health problems."181 even as far back as 2002, the federal health resources and services administration ("hrsa") partnered via contract with the american pharmacists association ("apha") to establish the 175. thomas e. menighan, pharmacy response to the "ama &ope of practice data series: pharmacists", drug topics (june 15, 2010), available at http://drugtopics. modemmedicine.corn!drugtopics!associations!pharmacy-response-to-the-ama-scope-of­ practice-dati articlestandardl article/detail/673895. 176. phil galewitz, health bills in congress won't fix doctor shortage, kaiser health news (oct. 13, 2009), http://www.kaiserhealthnews.org/stories/2009/0ctober/12/ primary-care-doctor-shortage.aspx. 177. jd. 178. thomas menighan, berwick says pharmacy central to health care team, am. pharmacists ass'n, ceo blog (dec. 3, 2010), http://blog.pharmacist.com/tmenighanl index.php/20 1 0/12/03/berwick-says-pharmacy-central-to-health-care-team/. 179. "aarp!walgreens wellness tour" to administer two millionth free health screening, prnewswlre, nov. 12, 2010, available at http://multivu.pmewswire.com/ mnr/walgreens/47199/. 180. id. 181. /d. 212 indiana health law review [vol. 9:1 pharmacy services support center ("pssc"), which "was created to ad­ dress the needs of pharmacists associated with hrsa grant projects and eligible community health centers to ensure patients have access to pharma­ ceuticals, medication management, and pharmacy services as part of their total health care."182 major patient organizations (aarp), government agencies such as hrsa, and of course pharmacy organizations--both for­ profit (walgreens) and not-for-profit (apha}-all see the value in pharma­ cists playing a role in providing health care to patients. why not then make pharmacists legal health care providers? 3. liability and provider status as the old adage goes, with privilege comes responsibility. pharma­ cists, if given provider status under the eyes of both the federal law as well as indiana state law, must take the privilege along with the heightened level of responsibility-including possible liability. for example, courts in the past have generally held pharmacists and pharmacies strictly liable for as­ surance "of the safety of a manufactured drug and would impose on the re­ tail druggist the obligation to test, at its own expense, new drugs. the costs to society, which needs and values the pharmaceutical products sold by druggists, would be unduly high."183 however, courts in the past have also taken pharmacists out of the equation and released them from a duty to warn relative to drug side effects and safety;184 but would this change if pharmacists were considered a health care provider under federal law and/or indiana state medical malpractice law? .jf pharmacists were included under indiana medical malpractice laws, liability may decrease, rather than increase, for pharmacists. as earlier stat­ ed, there is a two-year statutory window for bringing medical malpractice claims on "providers" in indiana; however, technically, because pharma­ cists are not considered "providers" under that statute, they in theory have no time limits for claims against them. 182. author unknown, the pharmacist as the primary care provider for the medically underserved, 43 j. am. pharmacists ass'n s52, s52 n.5 (2003). 183. ramierz v. richardson-merrell, inc., 628 f.supp. 85, 87 (e.d. pa. 1986); see also jeffery j. carlson, today 's pharmacist: a seller of products or a provider of services?, for the defense, nov. 1987, at 15. 184. ramierz, 628 f.supp. at 87; see also carlson, supra note 183, at 21 (this paper discussed ramierz, in which the court stated, "to impose a duty to warn on the pharmacist .. . would be to place the pharmacist between the physician ... and the patient. such interfer­ ence in the patient-physician relationship can only do more harm than good."). see also ingram v. hook's drugs, inc., 476 n.e.2d 881, 887 (ind. ct. app. 1985) ("the injection of a third-party in the form of a pharmacist into the physician-patient relationship could undercut the effectiveness of the ongoing medical treatment."). 2012] pharmacists as legal health care providers 213 iv. conclusion pharmacists are already giving care to patients in expanded means, beyond mere dispensing of medications. through longer and more thor­ ough education, board certifications, and additional training to provide im­ munizations, medication therapy management, and emergency/disaster relief, pharmacists are becoming more knowledgeable about primary care than ever in order to fill in the gaps where the needs of the rural, urban, and underserved populations are not currently being met. now, more than any time in u.s. history, the people need affordable solutions to their health care needs, and pharmacists are fulfilling those needs in unique and creative ways. the question that remains is: will payers, who are ultimately the federal government, state governments, and employers, finally recognize pharmacists as true health care providers? if pharmacists are already doing the work, they should have already earned provider status. it is time for the law-both federal and state-to match reality and make pharmacists legal health care providers. v. addendum three key events occurred in the past year relative to the movement toward pharmacists becoming legal health care providers. first,. on febru­ ary 3, 2011, the medication therapy management empowerment act of 2011, or s. 274 was introduced by senator kay hagan of north carolina with 15 cosponsors.185 the bill notes that the cost of improperly taking medication for the u.s. is $290 billion annually, andalsocites the asheville project.186 the bill essentially proposes improvements in part d mtm pro­ grams, including increased access for patients to mtm, expansion to other chronic diseases, and performance-based incentive payments for better medication adherence outcomes.187 the bill was read twice and referred to the committee on finance and currently sits in committee.188 second, a report from the u.s. public health service office of the chief pharmacist was written to the u.s. surgeon general. 189 in this report, pharmacists outlined that via evidence-based outcomes, pharmacists are, 185. s. 274, i 12th cong. (2011). 186. /d. at§ 2(3), (6). 187. /d.§ 3. 188. email from whitney zatzkin, policy and advocacy manager, the american as­ sociation of colleges of pharmacy, to erin albert, assistant professor of pharmacy, butler university (jan. 12,2012, 5:21pm) (on file with the author). 189. scorr gilberson et. al, office of the chief pharmacist, u.s. pub. health serv., improving patient and health system outcomes through advanced pharmacy practice. a report to the u.s. surgeon general, dec. 2011, available at http://www. usphs.gov/cotpslinks/pharmacy/comms/pd£12011 advancedpharmacypracticere porttotheussg.pdf. 214 indiana health law review [vol. 9:1 "already integrated into primary care as health care providers. pharmacists unquestionably deliver patient care services in a variety of practice settings through collaborative practice with physicians or as part of a health care team."190 the report also states, ''pharmacists may be the only health pro­ fessionals (who manage disease through medications and provide other patient care services) who are not recognized in national health policy as health care providers or practitioners. "191 one of the leading objectives of this report was to "[o]btain advocacy from the u.s. surgeon general to rec­ ognize pharmacists, who manage disease and deliver many patient care ser­ vices, as health care providers. one such action is advocate to amend the social security act to include pharmacists among health care professionals classifred as 'health care providers. "'192 the u.s. surgeon general, dr. regina benjamin, clearly read there­ port, and on december 14, 2011, issued a letter stating that the report pro­ vided, "a thorough discussion of the comprehensive patient care services that pharmacists are currently providing."193 the letter further stated, that, "recognition of pharmacists as health care providers, clinicians and an es­ sential part of the health care team is appropriate given the level of care they provide in many health care settings."194 thus, the perfect storm for pharmacists as providers under the social security act is documented, im­ minent and palpable. 190. id. at 7. 191. id. at 8 (emphasis added). 192. ld. at 10 (emphasis added). 193. letter from regina benjamin, md, mba, u.s. surgeon general, to radm scott giberson, chief professional officer, pharmacyu.s. assistant surgeon general (dec. 14, 2011 ), available at http://www.uspbs.gov/corpslinkslpharmacy/comms/pdf/2011 support letterfromussg.pdf. 194. ld. at 2. indiana health law review volume xvi 2019 number 2 symposium october 2018—symposium foreword introduction: exploring the intersection of immigration law and health policy aila hoss* on october 26, 2018, indiana university mckinney school of law’s hall center for law and health and indiana health law review cohosted its annual symposium entitled “the intersection of immigration law and health policy.”1 an interdisciplinary event, the symposium brought together colleagues across campus; across disciplines; and across the country. the topic of this symposium was selected during a hall center meeting in may 2018 following a review of recent news articles; journal publications; and conference presentations for emerging issues in health law. at that time, our newsfeed was flooded with reports regarding the trump administration’s newly implemented policies separating accompanied children crossing the border from their families.2 the u.s. department of health and human services was tasked with supervising these 3,000 children.3 organizations across the country and the world denounced this policy as among other things, harmful to the health and welfare of these children and their families.4 * visiting assistant professor, indiana university robert h. mckinney school of law. 1. iu robert h. mckinney school of law, indiana health law review symposium: the intersection of immigration law and health policy, https://mckinneylaw.iu.edu/events/past. html?eid=661. 2. donald j. trump, affording congress an opportunity to address family separation, white house (jun. 20, 2018), https://www.whitehouse.gov/presidential-actions/affordingcongress-opportunity-address-family-separation/.; office of the attorney gen., memorandum for federal prosecutors along the southwest border (april 6, 2018) https://www. justice.gov/opa/press-release/file/1049751/download. 3. admin. for children and families, unaccompanied alien children program, https://www.hhs.gov/sites/default/files/allegations-of-abuse-and-neglect-fact-sheet.pdf. 4. colleen kraft, aap statement on executive order on family separation, american acad. of pediatrics (jun. 20, 2018), https://www.aap.org/en-us/about-the-aap/aap-pressroom/pages/aap-statement-on-executive-order-on-family-separation.aspx.; american civil liberties union, trump’s family separation crisis, https://www.aclu.org/families-belongtogether.; fionnuala ní aoláin, global responses to president trump’s family separation via “zero-tolerance” detention policy, just security (jun. 30, 2018), https://www.justsecurity. 174 indiana health law review [vol. 16:173 months earlier, an underage, unaccompanied, undocumented immigrant sought an abortion that was opposed by the trump administration.5 this juvenile was only able to access pre-abortion medical care and an abortion following court orders.6 this issue continues to be litigated as other young immigrant women seek abortions and challenge the trump administration’s policies opposing them.7 immigration issues only continued to arise following the announcement of the symposium topic. for example, two weeks before the symposium, the trump administration published a notice of proposed rulemaking making aliens that access certain public benefits, including certain health and nutrition benefits, inadmissible for changes to their immigration status.8 tragically, two months following our symposium, two migrant children in custody with the department of state died under their care.9 what role does health law and do health attorneys have in these and other issues? the symposium sought to address this very question. our keynote speaker, professor wendy parmet10 kicked off the symposium with historical account of how immigration issues have been pervasive throughout u.s. history and the use of health policy to advance an immigration agenda has always undermined public health. from a population health perspective, we learned about the health disparities and risk of immigrant populations and debunked the perceived threats to public health with the inclusion of immigrants into our society. our healthcare provider colleagues described the challenges to caring for refugee and immigrant populations including language and transposition issues and, notably, lack of health insurance coverage. we explored case studies on the intersection of immigration and health law in california and canada. despite these jurisdictions’ reputation of being progressive in their health and immigration policies, numerous gaps in health care access among immigrant populations still exist. we also discovered the social justice and human rights perspectives on health care access for immigrants. local org/58783/global-responses-president-trumps-family-separation-zero-tolerance-detention-policy/. 5. scotusblog, azar v. garza, https://www.scotusblog.com/case-files/cases/azar-v-garza/. 6. id. 7. matt stevens, judge temporarily stops u.s. from blocking undocumented teenagers’ abortions, n.y. times (mar. 31, 2018), https://www.nytimes.com/2018/03/31/us/abortionimmigrant-teens.html. 8. fed. register, inadmissibility on public charge grounds (oct. 10, 2018), https://www.federalregister.gov/documents/2018/10/10/2018-21106/inadmissibility-on-publiccharge-grounds. 9. joshua barajas, “a second migrant child died in u.s. custody this month. here’s what we know,” pbs (dec. 26, 2018) https://www.pbs.org/newshour/nation/a-second-migrant-childdied-in-u-s-custody-this-month-heres-what-we-know. 10. matthews distinguished university professor of law and director, center for health policy and law; professor of public policy and urban affairs, northeastern university school of public policy and urban affairs. https://www.scotusblog.com/case-files/cases/azar-v-garza/ 2019] symposium foreword 175 advocates and community organizers discussed the challenges of coordinating campaigns supporting immigrant rights in the current political climate. from a legal practice perspective, we learned that immigration issues are often leading issues facing healthcare systems physician shortages. without immigrant physicians and other providers, many facilities would not be able to meet the demands of their patients and communities. in fact, the immigration practice group is the second largest at hall render, the nation’s largest health law firm. this symposium issue of the indiana health law review offers deeper analysis on the issues discussed during the symposium. in her article, professor parmet argues that when immigration and health policy intersect, it highlights existing divisions in the united states regarding community and solidarity and challenges us to define the purpose and explore the ethics of health law. professor medha makhlouf11 further describes the implications of the proposed public charge rules in her article first outlining the history of the policy and explaining how the recent changes are a significant departure from existing policy. she argues that public health implications should be a factor when developing public charge policies. professor polly price12 discusses the public health harms of argues that the proposed rules increase the risk of infectious disease threats in the united states because it disincentivizes immigrants to seek the very care that would treat and prevent the transmission of disease. she further describes how the rules create an extra burden on state and local health departments – responsible for frontline infectious disease prevention and response – that are already limited in resources. the intersection of immigration and health is a topic that implicates every aspect of health law whether access, public health, or financing. importantly, this symposium demonstrates the practical value of legal scholarship—particularly health law scholarship—on urgent policy issues. 11. assistant professor of law, director, medical-legal partnership clinic, penn state’s dickinson school of law. 12. asa griggs candler professor of law, emory university school of law. section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? spenser g. benge* i. introduction ............................................................... 194 a. a quick breakdown of the aca ............................... 195 1. health insurance exchanges ................................ 196 2. the individual mandate ........................................ 196 3. premium tax credits ............................................ 197 4. the guaranteed issue requirement ..................... 198 5. the community rating requirement ................... 198 b. the post-aca landscape: three insurance practices ........................................................ 198 c. section 1557 of the aca ........................................... 201 d. roadmap ................................................................... 202 ii. the three discriminatory health insurance practices ......................................................................... 202 a. the nature and standard of care for treating hiv/aids ........................................................................ 203 b. the detrimental effects of these three aforementioned practices on individuals with hiv/aids ............................................................... 204 1. high tiering ........................................................... 205 2. step therapy requirements .................................... 207 3. pre-authorization requirements ............................ 208 iii. covered entities under § 1557 ............................... 208 a. “federal financial assistance”................................. 209 b. “program or activity” ................................................ 213 http://dx.doi.org/10.18060/3911.0015 194 indiana health law review vol. 13:1 c. putting it together ................................................... 214 d. a wrinkle? ................................................................ 214 e. other means of § 1557 coverage.............................. 216 iv. high tiering and step-therapy and preauthorization requirements: discriminatory and prohibited under § 1557? ............................................... 217 a. what type of discrimination is prohibited by § 1557? ........................................................................ 217 b. intentional discrimination: prohibited? ................. 218 c. high tiering and step-therapy and pre-authorization requirements: intentional discrimination? .............................................................. 219 1. preliminary question 1: are these three insurance practices discriminatory to begin with? ............................................................. 219 2. preliminary question 2: do insurance companies have autonomy in choosing to adhere to these practices? ......................................... 221 3. are health insurance companies that are adhering to these practices exhibiting intentional discrimination? ....................................... 221 d. disparate impact discrimination: prohibited? ...... 227 e. high tiering and step-therapy and pre-authorization requirements: disparate impact discrimination? .................................................. 228 v. a policy consideration ............................................. 230 vi. conclusion ................................................................ 232 i. introduction before the passage of the affordable care act (“aca”), health insurers either completely refused to provide coverage 2016 195 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? to individuals with a preexisting condition,1 or charged such individuals grossly higher rates for coverage than those without a preexisting condition.2 because hiv/aids qualifies as a preexisting condition,3 these insurance practices have historically applied to individuals with hiv/aids. however, the passage of the aca changed that landscape. but before proceeding further with an explanation of the current landscape, a brief look at some of the key components of the aca is necessary. a. a quick breakdown of the aca the broad purpose of the aca is to expand health insurance to make it accessible to more americans.4 the aca accomplishes this goal with five main mechanisms: (1) health insurance exchanges,5 also referred to as health insurance marketplaces, (2) the individual mandate,6 (3) premium tax credits,7 (4) the guaranteed issue requirement,8 and (5) the community rating requirement.9 * j.d. candidate, 2016, indiana university robert h. mckinney school of law; b.s., 2013, indiana university – bloomington. 1 mark bolin, the affordable care act and people living with hiv/aids: a roadmap to better health outcomes, 23 annals health l. 28, 40-41 (2014); the affordable care act and hiv/aids, aids.gov, https://aids.gov/federal-resources/policies/health-care-reform/ [http:// perma.cc/bg4y-b69q] (last revised mar. 6, 2015). 2 the affordable care act and hiv/aids, supra note 1; bolin, supra note 1; alan i. widess, hiv infection among women of reproductive age, children, and adolescents: to insure or not to insure persons infected with the virus that causes aids, 77 iowa l. rev. 1617, 1680 (1992). 3 the affordable care act and hiv/aids, supra note 1. 4 nat’l fed’n of indep. bus. v. sebelius, 132 s. ct. 2566, 2580 (2012). 5 42 u.s.c. § 18031(b)(1) (2015); 42 u.s.c. § 18041(c)(1) (2015). 6 26 u.s.c. § 5000a (2015). 7 26 u.s.c. § 36b (2015). 8 42 u.s.c. §§ 300gg-300gg–7 (2015). 9 id. 196 indiana health law review vol. 13:1 1. health insurance exchanges the health insurance exchanges are online marketplaces that individuals can utilize to compare and purchase health insurance plans.10 the exchanges are meant to be a sort of one-stop shop for health insurance.11 the idea is that each state’s exchange will provide people that are looking for health insurance with an opportunity to view and compare plans side-by-side; this format was designed to increase competition between health insurers and thus promote better and cheaper health plans.12 the aca also uses the exchanges as a mechanism for regulation. many of the aca’s regulations apply only to plans that are offered and obtained through the exchanges.13 2. the individual mandate the individual mandate, put simply, requires americans to purchase minimum essential coverage health insurance or else pay a tax penalty.14 however, the aca’s unaffordability exemption provides that if the cost of the cheapest plan on a state’s exchange exceeds 8% of an individual’s income, that person is not required to purchase health insurance and is also exempt from the tax penalty that would normally be assessed to persons who do not have health insurance.15 10 health insurance marketplace, healthcare.gov, https:// www.healthcare.gov/glossary/health-insurance-marketplace-glossary/ [http://perma.cc/f5nw-dwsa] (last visited sept. 16, 2015). 11 creating a new competitive health insurance marketplace, cms.gov, http://www.cms.gov/cciio/resources/marketplace-grants/ [http://perma.cc/34qw-5vyj] (last visited sept. 16, 2015). 12 health insurance marketplace, supra note 10. 13 bernadette fernandez, health insurance exchanges under the patient protection and affordable care act (aca), congressional research service (jan. 31, 2013), https://www.fas.org/sgp/crs/misc/ r42663.pdf [https://perma.cc/hkw5-3qmc]. 14 26 u.s.c. § 5000a (2015). 15 26 u.s.c. § 5000a(e)(1)(a); exemptions from the fee for not having health insurance, healthcare.gov, https:// www.healthcare.gov/fees-exemptions/exemptions-from-the-fee/ [http:// perma.cc/457y-58t6] (last visited sept. 16, 2015). https://a.next.westlaw.com/link/document/fulltext?findtype=l&pubnum=1000546&cite=26uscas5000a&originatingdoc=i9246fc2099b611e381b8b0e9e015e69e&reftype=rb&originationcontext=document&transitiontype=documentitem&contextdata=(sc.search)#co_pp_d39300002d0e0 2016 197 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? there are also a number of other exemptions that allow individuals to not purchase health insurance and still avoid the tax penalty, most of which involve circumstances in which an individual is under financial stress.16 however, since the aca expanded medicaid to cover all individuals between the ages of 18 and 65 whose income does not exceed 138% of the federal poverty level, many of the individuals that qualify for these exemptions that stem from a lowincome will still have access to health insurance.17 3. premium tax credits more relevant here are the premium tax credits that the aca provides. these tax credits are provided to lowand middle-income americans to subsidize the premiums of insurance they purchase through the exchanges. because of this function, they are often referred to as premium subsidies.18 premium subsidies are available to individuals and families with an annual income of up to 400% of the federal poverty level.19 these premium subsidies are paid by the federal government directly to a qualifying individual’s insurance provider in order to subsidize the qualifying individual’s premiums under the plan.20 16 exemptions from the fee for not having health insurance, supra note 15. 17 medicaid expansion & what it means for you, healthcare.gov, https://www.healthcare.gov/medicaid-chip/medicaid-expansion-and-you/ [http://perma.cc/eq68-ucj7] (last visited sept. 16, 2015). 18 26 u.s.c. § 36b (2015); premium tax credit, healthcare.gov, https://www.healthcare.gov/glossary/premium-tax-credit/ [http:// perma.cc/6b9u-epq4] (last visited sept. 16, 2014). 19 explaining health care reform: questions about health insurance subsidies, kaiser family found. (oct. 27, 2014), http://kff.org/ healthreform/issue-brief/explaining-health-care-reform-questions-abouthealth/ [http://perma.cc/xm22-p7fk]. 20 42 u.s.c. § 18082 (2015); subsidies: tax credits for eligible consumers, assurant health, http://www.assuranthealth.com/corp/ ah/healthcarereform/premium-subsidy.htm [http://perma.cc/ d4fztplj] (last visited sept. 16, 2015); premium tax credit, supra note 18. 198 indiana health law review vol. 13:1 4. the guaranteed issue requirement also very pertinent to this situation is the aca’s guaranteed issue requirement. this requirement means that health insurers may not deny any individual coverage because that person has a preexisting condition,21 such as hiv/aids.22 5. the community rating requirement the community rating requirement makes it illegal for health insurers to discriminate against individuals with a preexisting condition,23 such as hiv/aids,24 in terms of the price of coverage. this requirement means that health insurers cannot charge individuals with a preexisting condition a higher rate for coverage than individuals without a preexisting condition.25 however, there are a few exceptions. health insurers can still charge higher rates to individuals based on age, tobacco use, and geography.26 this means that rates may be higher for individuals that are older, use tobacco, or live in a geographic region of the u.s. in which medical costs are higher than average.27 b. the post-aca landscape: three insurance practices as has just been briefly explained, the aca has many moving parts that together create an environment that is supposed to bring access to affordable, quality health insurance to everyone, regardless of their health status or history. the guaranteed issue and community rating 21 42 u.s.c. §§ 300gg-300gg–7 (2015). 22 health insurance market reforms: rate restrictions, kaiser family found. (june 2012), http:// kaiserfamilyfoundation. files.wordpress.com/2013/01/8328.pdf [http://perma.cc/27gr-g2z4]; the affordable care act and hiv/aids, supra note 1. 23 42 u.s.c. §§ 300gg-300gg–7 (2015). 24 health insurance market reforms: rate restrictions, supra note 22. 25 id. 26 42 u.s.c. §§ 300gg (2015). 27 health insurance market reforms: rate restrictions, supra note 22. 2016 199 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? requirements are two of the most important of these moving parts. together, they mean that health insurers can no longer refuse to cover individuals with hiv/aids28 or charge such individuals a higher rate for coverage than those without the disease.29 however, some insurers are finding more subtle ways to continue discriminating against individuals with hiv/aids in an attempt to discourage them from enrolling in their plans.30 specifically, these insurers have continued to discriminate in three main ways. first, many insurers are discriminating via the design of their prescription drug formularies.31 these insurers design their formularies with 28 the affordable care act and hiv/aids, supra note 1. 29 42 u.s.c. §§ 300gg, 300gg–2 (2015). 30 michelle andrews, some plans skew drug benefits to drive away patient, advocates warn, kaiser family found. (july 8, 2014), http://www.kaiserhealthnews.org/stories/2014/july/08/some-plans-skewdrug-benefits-to-drive-away-patients-advocates-warn.aspx [http://perma.cc/v2vu-vblg]. 31 letter from thomas d. yates, exec. dir., aids legal council of chi. & john peller, ceo, aids found. of chi., to andrew boron, dir., ill. dep’t of ins., 13 (apr. 1, 2014) (on file with aids found. of chi.), available at http://www.afc.01.thirdwaveweb.com/resources/legacy/images/2014/ alcc_afc_jenner_letter_re_hiv_meds_marketplace_updated_apr_1_ 2014.pdf [http://perma.cc/q9xy-t6ux]; see press release, aids found. of chi., cost of hiv medications in the illinois health insurance marketplace, 1 (mar. 13, 2014) (on file with aids found. of chi.), available at http://www.hivhealthreform.org/wp-content/uploads/2014/ 03/il-hiv-med-coverage-marketplace-march-20-2.pdf [http://perma.cc/ 5w4t-edzv]; letter from robert greenwald, dir., harvard law sch. ctr. for health law & policy innovation, to kathleen sebelius, sec’y of the dep’t of health & human serv. (oct. 21, 2013) (on file with harvard law school center for health law & policy innovation) available at http://www.hivhealthreform.org/wp-content/uploads/2013/10/hhsletter-with-insurer-letter-and-contacts-enclosed.pdf [https://perma.cc/ 84n4-rqgn]; michelle andrews, complaint says insurance plans discriminate against hiv patients, npr (july 8, 2014), http://www.npr.org/blogs/health/2014/07/08/329591574/complaint-saysinsurance-plans-discriminate-against-hiv-patients [http://perma.cc/ 8qbj-4xdy]; andrews, supra note 30; fair pricing coal., health insurance marketplace plans and people living with hiv and/or viral hepatitis: the affordable care act requires fair drug pricing and access, fpc, http://fairpricingcoalition.org/wp-content/ uploads/ 2014/02/fpc-qhp-policy-guide-feb-2014-1.pdf [http://perma.cc/r89mmb68] (last visited sept. 16, 2014). 200 indiana health law review vol. 13:1 all or most of the effective hiv/aids medications on the highest tiers.32 these tiers are characterized by very high cost sharing and deductibles, thus, making the medications placed on these tiers virtually unaffordable.33 for brevity, i will often refer to this practice as “high tiering.” second, many insurers discriminate against individuals with hiv/aids, who take hiv/aids medications, by imposing step-therapy requirements.34 step-therapy requirements force individuals to use less effective drugs in order to prove them to be ineffective before qualifying for the use of effective medications.35 and third, these insurers impose preauthorization requirements for hiv/aids medications.36 pre-authorization requirements force individuals to obtain permission from their insurer before every refill of their medications.37 these three insurance practices undermine the broad goal of the aca and its provisions, that prohibit 32 yates, supra note 31, at 16; see aids found. of chi., supra note 31; greenwald, supra note 31; andrews, supra note 31; andrews, supra note 30; fair pricing coal., supra note 31. 33 yates, supra note 31, at 16; see aids found. of chi., supra note 31; andrews, supra note 30. 34 yates, supra note 31, at 2; aids found. of chi., illinois governor’s office warns aca health insurance plans against hiv/aids discrimination, [hereinafter illinois governor’s office] aidschicago.org (may 27, 2014), http://www.aidschicago.org/illinois-news/891-illinoisgovernors-office-warns-aca-health-insurance-plans-against-hivaidsdiscrimination [http://perma.cc/l3gc-ebur]; letter from the steering comm. of the hiv health care access working group, to the office for civil rights, u.s. dep’t of health & human servs. (sept. 30, 2013) (on file with the steering comm. of the hiv health care access working group), available at http://www.nastad.org/docs/ 123257_ hhcawg%20non%20disc%20rfi%20response%20final.pdf. [http://perma.cc/cx39-heks]. 35 yates, supra note 31, at 2; see also illinois governor’s office, supra note 34; steering comm. of the hiv health care access working group, supra note 34. 36 yates, supra note 31, at 2; see hiv med. ass’n. et. al, doctors & advocates demand better health coverage for hiv & hepatitis, hivandhepatitis.com (feb. 7, 2014), http:// www.hivandhepatitis.com/ hiv-policy-advocacy/4514-medical-experts-and-advocates-urge-betterhealth-coverage-for-people-with-hiv-and-hepatitis [http://perma.cc/ 5ep7-ces4]; see also illinois governor’s office, supra note 34; steering comm.of the hiv health care access working group, supra note 34. 37 yates, supra note 31, at 2; see hiv med. ass’n. et. al, supra note 36; see also illinois governor’s office, supra note 34; steering comm. of the hiv health care access working group, supra note 34. 2016 201 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? discrimination based on preexisting condition, by discriminating against individuals with hiv/aids, discouraging such individuals from enrolling in health plans, and making health insurance less accessible to them. c. section 1557 of the aca fortunately, § 1557 of the aca may be an effective weapon in combating these three discriminatory practices. section 1557 is the aca’s broad nondiscrimination provision. in relevant part, it provides: (a) in general. except as otherwise provided for in this title (or an amendment made by this title), an individual shall not, on the ground prohibited under title vi of the civil rights act of 1964 (42 u.s.c. 2000d et seq.), title ix of the education amendments of 1972 (20 u.s.c. 1681 et seq.), the age discrimination act of 1975 (42 u.s.c. 6101 et seq.), or section 504 of the rehabilitation act of 1973 (29 u.s.c. 794), be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving federal financial assistance, including credits, subsidies, or contracts of insurance, or under any program or activity that is administered by an executive agency or any entity established under this title (or amendments). the enforcement mechanisms provided for and available under such title vi, title ix, section 504, or such age discrimination act shall apply for purposes of violations of this subsection.38 most relevant here is that §1557 prohibits discrimination “on the ground . . . prohibited under section 504 of the 38 patient protection and affordable care act, pub. l. no. 148, § 1557, 124 stat. 119 (2010) (codified as amended at 42 u.s.c. § 18116 (2010)). 202 indiana health law review vol. 13:1 rehabilitation act of 1973,”39 which prohibits discrimination on the basis of disability.40 since hiv/aids has been held by the supreme court—and other courts—to be a disability,41 §1557 through § 504 of the rehabilitation act prohibits discrimination based on hiv/aids. however, the analysis of § 1557 as applied to these three insurance practices does not end there. d. roadmap this note seeks to determine whether § 1557 will be effective at ending, or at least reducing, insurers’ discrimination against individuals with hiv/aids in the form of high tiering, step-therapy and pre-authorization requirements. to make this determination, this note will adhere to the following itinerary. first, this note will explain in more detail the detrimental effects of the three aforementioned health insurance practices on individuals with hiv/aids in order to facilitate an understanding as to why they should be opposed. next, it will examine what entities § 1557 applies to. then, this note will discuss whether § 1557 prohibits intentional discrimination, and if so, whether these three insurance practices constitute such prohibited intentional discrimination. next will be a discussion of whether § 1557 prohibits disparate impact discrimination, and if so, whether such discrimination is present in this case. and finally, a policy consideration for the application of § 1557 will be discussed. ii. the three discriminatory health insurance practices without an understanding of the nature of the hiv/aids virus and the standard of care for treating it, the harmful effects these three aforementioned insurance practices have 39 42 u.s.c. § 18116(a) (2015). 40 29 u.s.c. § 794(a) (2015). 41 e.g., bragdon v. abbott, 524 u.s. 624, 630-47 (1998) (ada); doe v. cnty. of ct., pa, 242 f.3d 437, 447 (3d cir. 2001) (rehabilitation act); chalk v. u.s. dist. ct. c.d. cal., 840 f.2d 701, 705-09 (9th cir. 1988) (rehabilitation act). 2016 203 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? on individuals with hiv/aids cannot be fully appreciated. therefore, a brief overview of hiv/aids is appropriate. a. the nature and standard of care for treating hiv/aids hiv/aids is an extremely complex virus that attacks the human immune system.42 hiv/aids can replicate billions of times per day and has a very error-prone replication process; as a result, it has an extremely high mutation rate.43 because of this, treating hiv/aids is very difficult. in order to effectively manage the virus, multiple hiv/aids medications must be used in unison.44 furthermore, any cessation in an individual taking medication gives the virus the opportunity to replicate, mutate, and become resistant to that medication.45 drug resistant hiv/aids is extremely troubling because not all hiv/aids medications work for a particular individual,46 and many hiv/aids medications have toxic side effects.47 so if a person has a lapse in taking his or her effective medication, and their strain of hiv/aids becomes resistant to that medication as a result, that person cannot continue to take that drug and may have a limited selection of other 42 what is hiv/aids?, aids.gov, http://www.aids.gov/hiv-aidsbasics/hiv-aids-101/what-is-hiv-aids/ [http://perma.cc/x42q-9mkw] (last revised apr. 29, 2014). 43 primer on hiv resistance, stanford university hiv drug resistance database, http://hivdb.stanford.edu/pages/documentpage/ primer.html [http://perma.cc/5r9u-dhas] (last updated sept. 23, 1999). 44 panel on antiretroviral guidelines for adults and adolescents, guidelines for the use of antiretroviral agents in hiv-1-infected adults and adolescents, dep’t of health & hum. services d-1, http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pd f [http://perma.cc/z8x9-dh5b] (last visited sept. 17, 2015). 45 id. at k-1. 46 changing/stopping treatment, aids.gov, https://www.aids.gov/ hiv-aids-basics/just-diagnosed-with-hiv-aids/treatment-options/ changing-stopping-treatment/ [http://perma.cc/qt4m-v39e] (last revised aug. 7, 2009). 47 yates, supra note 31, at 5; antiretroviral drugs side effects, avert, http://www.avert.org/antiretroviral-drugs-side-effects.htm [http://perma.cc/crg3-d84a] (last visited sept. 17, 2015). 204 indiana health law review vol. 13:1 drugs to switch to due to side effects and ineffectiveness. because of this, the medical standard of care for treating hiv/aids provides that a person diagnosed with hiv/aids begin taking medication as soon as possible after being diagnosed and have no lapses in treatment.48 in order to facilitate this, the medical standard of care provides that the most effective way to treat hiv/aids patients is with a single-tablet regimen (str) instead of multiple pills per day49—this increases adherence to treatment, decreasing dangerous interruptions in treatment.50 the medically “preferred regimens” of strs for treating hiv/aids include atripla, truvada-reyataz-norvir, truvada-prezista-norvir, truvada-isentress, stribild, tivicay-epzicom, and tivicaytruvada.51 with a better understanding of how hiv/aids works and is treated, a look into how high tiering, step-therapy, and preauthorization requirements can negatively affect individuals with hiv/aids is now appropriate. b. the detrimental effects of these three aforementioned practices on individuals with hiv/aids the next three subsections will explain how high tiering, step-therapy, and pre-authorization requirements can have harmful consequences for individuals with hiv/aids. 48 panel on antiretroviral guidelines for adults and adolescents, supra note 44, at k-1. 49 liz highleyman, single-tablet regimen improves antiretroviral adherence and reduces hospitalization, aidsmap (sept. 26, 2013), http://www.aidsmap.com/single-tablet-regimen-improves-antiretroviraladherence-and-reduces-hospitalisation/page/2763722/ [http://perma.cc/ x8yw-95bp]. 50 yates, supra note 31, at 17. 51 aids found. of chi., supra note 31, at 3-12. 2016 205 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? 1. high tiering hiv/aids medications are very expensive.52 a 30-day supply of norvir costs $530-$58653; a 30-day supply of prezista costs $1,279-$1,38354; a 30-day supply of reyataz costs $1,288-$1,39355; a 30-day supply of truvada costs $1,309-$1,41156; and generic versions of these drugs are not available in the united states.57 but even drugs that do have generic alternatives available in the united states are expensive.58 for example, a 30-day supply of generic combivir is $172-$375, and a 30-day supply of generic ziagen is $117-$219.59 and remember, it is necessary for an individual with hiv/aids to take not only one of these drugs, but a combination of these drugs in unison.60 but, one might think, the above numbers are the total costs of the drugs; with insurance the drugs are probably cheap enough that people can afford them, right? not when these drugs are placed on the highest cost sharing tiers of a health insurers’ prescription drug formulary.61 in illinois, aetna, coventry, and humana all place most hiv/aids medications, and indeed all of the medically preferred regimens, on the highest tiers of their formularies.62 for example, under the best plan that aetna 52 see kimberly holland & kristeen cherney, the cost of hiv treatment, healthline (april 2, 2015), http:// www.healthline.com/ health/hiv-aids/cost-of-treatment#1 [http://perma.cc/2xey-sshl]; madeline vann, can you afford your hiv treatment?, everyday health, http://www.everydayhealth.com/hiv-aids/can-you-afford-hivtreatment.aspx [http://perma.cc/rz8l-ubuf] (last updated may 13, 2009). 53 holland, supra note 52. 54 id. 55 id. 56 id. 57 id. 58 id. 59 id. 60 panel on antiretroviral guidelines for adults and adolescents, supra note 44. 61 yates, supra note 31, at 16–17; see aids found. of chi., supra note 31; andrews, supra note 30. 62 aids found. of chi., supra note 31. 206 indiana health law review vol. 13:1 offers on the illinois health insurance exchange, the monthly out-of-pocket cost to a plan beneficiary for atripla is about $1,126; for truvada-reyataz-norvir is about $1,541; for truvada-prezista-norvir is about $1,542; for truvadaisentress is about $1,348; for stribild is about $2,830; for tivicay-epzicom is about $654; and for tivicay-truvada is about $783.63 under the best plan that coventry offers on the illinois health insurance exchange, the monthly out-of-pocket cost to a plan beneficiary for atripla is about $676; for truvadareyataz-norvir is about $763; for truvada-prezista-norvir is about $763; for truvada-isentress is about $686; for stribild is about $843; for tivicay-epzicom is about $703; and for tivicay-truvada is about $792.64 and under the best plan that humana offers on the illinois health insurance exchange, the monthly out-ofpocket cost to a plan beneficiary for atripla is about $1,126; for truvada-reyataz-norvir is about $1,541; for truvadaprezista-norvir is about $1,542; for truvada-isentress is about $1,348; for stribild is about $1,405; for tivicayepzicom is about $1,172; and for tivicay-truvada is about $1,321.65 in 2013, the median household, or combined family, income ranged from about $90,000 to about $45,000 per year.66 so if someone with a $60,000 yearly salary were to have the best plan that humana offers through the illinois marketplace and that person had been prescribed atripla, he or she would be spending over 22% of their yearly income on their atripla alone. if someone with a $45,000 yearly salary were to have the best plan that humana offers through the illinois marketplace and that person had been prescribed atripla, he or she would be spending about 30% of their yearly income on their atripla alone. thirty percent of a family’s income is a substantial amount, to say the least. thus, it seems safe to say that when these drugs are placed 63 id. 64 id. 65 id. 66 amanda noss, household income: 2013, american community survey briefs, u.s. census bureau (sept. 2014), http:// www.census.gov/ content/dam/census/library/publications/2014/acs/acsbr13-02.pdf [http:// perma.cc/kg7d-8898]. 2016 207 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? in an insurer’s highest formulary tiers, they are extremely expensive and virtually unaffordable to most lowand middle-income americans. it is apparent that this practice of high tiering by insurers can be financially challenging, or even crippling—depending on an individual’s income. this financial burden by itself imposes great harm to individuals with hiv/aids. however, the harm does not stop at the pocketbook. such a high cost for these drugs can mean that many people with hiv/aids cannot afford their medication every month. what happens when someone cannot afford to pay for his or her medication for a month? answer: they do not take it. this is a lapse in treatment, which can lead to a dangerous strain of drugresistant hiv/aids.67 in sum, this high tiering practice may not only create an extreme financial burden on beneficiaries with hiv/aids, but can also lead to medically dangerous lapses in treatment. 2. step therapy requirements step-therapy requirements force individuals to use less effective drugs in order to prove they are ineffective before qualifying for the use of effective medications.68 the medical standard of care dictates that an individual should begin treatment as soon as possible after being diagnosed with hiv/aids and have no lapses in treatment.69 this keeps the virus at bay from mutation and thus prevents drug resistance.70 step-therapy, by its very nature, violates this standard of care and gives the virus the opportunity to mutate and become drug resistant because either: (1) a person is diagnosed with hiv/aids and enrolls in a plan—or is already enrolled in a plan—with a step-therapy requirement that requires them to take less-than-optimallyeffective drugs for a period of time, which functionally 67 yates, supra note 31, at 4. 68 yates, supra note 31, at 2; see illinois governor’s office, supra note 34; steering comm. of the hiv health care access working group, supra note 34. 69 panel on antiretroviral guidelines for adults and adolescents, supra note 44. 70 see id. 208 indiana health law review vol. 13:1 constitutes a delay in initial treatment; or (2) a person who has had hiv/aids for some time and has been using an effective drug enrolls in a plan that has a step-therapy requirement and must switch to a less effective drug for a period of time, which functionally constitutes a lapse in treatment. it is in this way that step-therapy requirements harm individuals with hiv/aids who are subjected to them. 3. pre-authorization requirements pre-authorization requirements have largely the same effect that step-therapy requirements do: they cause lapses in treatment. this is because pre-authorization requirements mandate that beneficiaries must obtain permission from the insurer before every refill of their medication,71 and due to the large size and bureaucratic nature of insurance companies, that permission can often take longer to obtain than expected.72 this delay in permission from the insurance companies can lead to dangerous lapses of treatment. it is in this way that preauthorization requirements harm individuals with hiv/aids who are subjected to them. it is apparent that these three health insurance practices are acutely detrimental to individuals with hiv/aids who are subject to them. however, § 1557 may be able to neutralize these practices and provide such individuals with relief from this discrimination. an analysis of § 1557 and its possible application to such practices follows. iii. covered entities under § 1557 to determine whether § 1557 of the aca will be effective at ending, or at least reducing, insurers’ practices of high tiering and step-therapy and pre-authorization requirements with hiv/aids medications, it is necessary to determine what entities the provision actually applies to. to be an effective means of combating these health insurance practices, § 1557 must extend to the vast majority of health 71 yates, supra note 31, at 15; see hiv med. ass’n. et. al, supra note 36; see illinois govenor’s office, supra note 34. 72 yates, supra note 31, at 15. 2016 209 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? insurance companies and thus by extension to the health plans they provide. section 1557 applies to “any health program or activity, any part of which is receiving federal financial assistance, including credits, subsidies, or contracts of insurance, or under any program or activity that is administered by an executive agency or any entity established under this title (or amendments).”73 there are two key pieces at work here: “health program or activity” and “federal financial assistance.” therefore, to determine whether § 1557 extends to health insurance companies, these two key pieces must be examined. first, it must be determined what “federal financial assistance” is and whether health insurance companies receive it. and second, it must be determined what a health “program or activity” is and if health insurance companies qualify as such a health “program or activity.” if health insurance companies do qualify as health “programs or activities” and receive “federal financial assistance,” section 1557 will apply to such health insurers. a. “federal financial assistance” what qualifies as “federal financial assistance?” there is a vast array of federal programs that provide various types of assistance. however, the aca’s premium tax credits will be focused on here. this is partly due to the impracticability of exploring every federal program that provides financial assistance and partly due to the importance and prominence of the premium tax credits. the premium tax credits are especially pertinent in the context of § 1557 covered entities because many people will qualify for them.74 so if these credits qualify as “federal financial assistance” then many insurers will receive such federal assistance because they provide coverage to those individuals who qualify for the credits. 73 42 u.s.c. § 18116(a) (2015). 74 state-by-state estimates of the number of people eligible for premium tax credits under the affordable care act, kaiser family foundation (nov. 5, 2013), http://kff.org/report-section/state-by-stateestimates-of-the-number-of-people-eligible-for-premium-tax-creditsunder-the-affordable-care-act-table-1/ [http://perma.cc/x3fm-qztc]. 210 indiana health law review vol. 13:1 section 1557 explicitly provides that “federal financial assistance” includes “credits, subsidies, or contracts of insurance.”75 the “credits” and “subsidies” referred to by § 1557 seemingly refer to—or at least include—the premium tax credits provided pursuant to the aca. this makes sense for two reasons. first, it is logical for § 1557 to refer to and use such a key piece of the act of which it is a part of to effect its specific purpose. as was explained above, the premium tax credits are a key part of the aca. without the premium tax credits, the aca could not stand.76 it makes sense for the aca to use such a key component of itself to be the foundation of this nondiscrimination provision. and second, the premium tax credits are both a “credit”—in that they are literally a tax credit—and a “subsidy”—in that they literally subsidize insurance premiums. furthermore, the premium tax credits are the epitome of “federal financial assistance;” the federal government is literally assisting in the payment of insurance premiums. as the analysis above illustrates that it is likely that premium tax subsidies qualify as “federal financial assistance,” the next inquiry to make here is: will most health insurance companies receive these premium tax subsidies? more and more health insurance companies offer, or will offer, health plans through the exchanges.77 thus, it is very likely that each insurer offering plans through the exchanges will inevitably receive premium subsidies through beneficiaries of some of those plans. this is because the premium subsidies are available for individuals and families with incomes up to 400% of the federal poverty level, which encompasses an extremely large group of people.78 with a 75 42 u.s.c. § 18116(a) (2015). 76 joel e. miller, healthcare reform: the “three-legged stool” of health insurance reform under the aca, amhca (oct. 1, 2013), http://www.amhca.org/?page=advocate20131002 [http://perma.cc/8fa5m9bv]. 77 tami luhby, more health insurers offer obamacare plans, cnn money (sept. 23, 2014 3:58 pm), http://money.cnn.com/2014/09/23/ news/economy/obamacare-more-health-insurers-on-exchanges/ [http:// perma.cc/kd7f-tffd]. 78 explaining health care reform: questions about health insurance subsidies, kaiser family foundation (oct. 27, 2014), http://kff.org/health-reform/issue-brief/explaining-health-care-reform2016 211 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? large, and increasing, number of health insurers offering plans on the exchanges and with a large portion of the population qualifying for premium subsidies, the vast majority of health insurers are likely to receive premium subsidies—“federal financial assistance”—via the beneficiaries of their plans that are sold on the exchanges. however, at first blush, there seems to be a wrinkle here. while the premium subsidy is paid directly to the insurer,79 in actuality it is a premium tax credit of the individual who purchases the plan, and it subsidizes the cost of insurance to the individual. therefore, one might think, the individuals, not the insurers, are receiving the “federal financial assistance.” however, this argument is not consistent with the law. in moreno v. consolidated rail corp., moreno, a terminated employee of the railroad company conrail, filed suit under § 504 of the rehabilitation act alleging that his termination was due to his disability–diabetes.80 in response, conrail maintained that it was not a recipient of federal financial assistance and therefore not subject to § 504 regulation.81 conrail received government money for railroad crossing improvements.82 the improvements were paid to the state of michigan and then subsequently to conrail.83 conrail argued that while it did receive such government money, it was not the “recipient” of federal financial assistance because the ultimate beneficiary was the traveling public, who benefitted from safe railroad crossings.84 the court found this argument unpersuasive, questions-about-health/ [http://perma.cc/ew37-6632]; state-by-state estimates of the number of people eligible for premium tax credits under the affordable care act, supra note 74. 79 42 u.s.c. § 18082 (2015); subsidies: available to eligible consumers, assurant health, http://www.assuranthealth.com/corp/ ah/healthcarereform/premium-subsidy.htm [http://perma.cc/czl57rrc] (last visited sept. 17, 2015); premium tax credit, healthcare.gov, https://www.healthcare.gov/glossary/premium-taxcredit/ [http://perma.cc/5yt4-pmk3] (last visited sept. 17, 2015). 80 moreno v. consol. rail corp., 99 f.3d 782, 784 (6th cir. 1996). 81 id. 82 id. at 785-786. 83 id. 84 id. at 787. 212 indiana health law review vol. 13:1 and further found the fact that conrail received the money from the federal government through the state of michigan as a middle-man to be immaterial.85 the court held conrail to be a recipient of “federal financial assistance.”86 similarly, the supreme court, in grove city college v. bell, spoke on the scope of the coverage of antidiscrimination statutes.87 in grove city college, a college refused to agree to the antidiscrimination terms under title ix of the education amendments of 1972 in order to utilize certain student educational funding.88 the court found that although the students were the ultimate beneficiaries of the student educational funding, the college was a “recipient” of federal financial assistance due to such government funding.89 in addition, the department of health and human services (“hhs”) has issued a regulation which defines a “recipient” under § 504 as “any state . . . or any person to which federal financial assistance is extended directly or through another recipient . . . but excluding the ultimate beneficiary of the assistance.”90 in the current situation, the ultimate beneficiary of the premium subsidies are the individuals who qualify for such premium tax credits. however, the premium subsidies are paid from the federal government directly to the health insurer.91 indeed, this is more direct than in moreno when the state of michigan acted as a middle-man and the court in that case still found conrail to be a recipient of “federal financial assistance.” in addition, the health insurers in the current situation are like conrail in moreno and the college in grove city college: although they are not the true beneficiaries of the federal funds, they still qualify as recipients of “federal financial assistance.” indeed, individuals who qualify for premium tax credits are equivalent to the students in grove city college who 85 moreno v. consolidated rail corp., 99 f.3d at 787-788. 86 id. 87 grove city college v. bell, 465 u.s. 555 (1984). 88 id. at 561. 89 id. at 569–570. 90 45 c.f.r. § 84.3(f) (2015). 91 42 u.s.c. § 18082 (2015); subsidies: tax credits for eligible consumers, supra note 79; premium tax credit, supra note 79. 2016 213 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? qualified for student educational funding. they are the ultimate beneficiaries of the funding, but because the money is paid to the institution handling their affairs, the institution is the recipient of “federal financial assistance” for legal purposes. moreover, the hhs regulations have specifically excluded ultimate beneficiaries, such as the students in grove city college or the plan beneficiaries who qualify for premium tax credits in the current situation, from being the legal recipients of “federal financial assistance” and instead designated the entity that the government money is extended to as the recipient. therefore, health insurance companies become the recipients of “federal financial assistance” when they receive government money in the form of premium tax subsidies. this greatly expands the coverage of § 1557. also keep in mind that there are many other ways that an insurer can receive “federal financial assistance” aside from premium tax subsidies. taking that into consideration, § 1557’s coverage is broader still. therefore, most insurance companies in the united states will likely receive “federal financial assistance.” b. “program or activity” since, in this context, discrimination against individuals with hiv/aids is prohibited by § 1557 through its invocation of § 504 of the rehabilitation act, and because § 1557 does not specifically define “program or activity,” it seems appropriate to use the definition of “program or activity” provided by § 504 of the rehabilitation act. section 504 of the rehabilitation act provides that, among other things, a “program or activity” means all operations of: (3)(a) an entire corporation, partnership, or other private organization, or an entire sole proprietorship—(i) if assistance is extended to such corporation, partnership, private organization, or sole proprietorship as a whole; or (ii) which is principally engaged in the business of providing education, health care, housing, social services, or parks and recreation[.]92 92 29 u.s.c. § 794(b) (2015). 214 indiana health law review vol. 13:1 with this definition, it is now possible to answer the question: do health insurance companies qualify as health “programs or activities?” insurance companies are corporations. however, there are a great many insurance companies in the united states and not all of their corporate structures are the same. this makes a broad analysis of whether health insurers receive assistance “as a whole” overly cumbersome. this point is also moot due to the second portion of the definition of “program or activity” presented above. this is because even if a health insurer does not receive the assistance “as a whole,” they still qualify as a “health program or activity.” the second piece of the definition of health “program or activity” only requires that the corporation be “principally engaged in the business of providing . . . health care.” since insurance companies are “principally engaged in the business of providing” health care, they likely qualify as a “program[] or activit[y].” c. putting it together having explored the two key pieces of § 1557 that describe covered entities, it is now appropriate to put those two key pieces together in regard to health insurance companies— and by extension the health plans such insurers provide. health insurance companies likely qualify as health “programs or activities”; and they will probably receive “federal financial assistance” in one form or another; therefore, they are likely covered entities under § 1557. however, the covered entity analysis does not stop here; there is one important question that must still be answered. d. a wrinkle? if a health insurance company receives federal financial assistance in the form of the aca’s premium subsidies from one plan offered through an exchange, does that company have to make sure that all of the plans it offers, both in and out of the exchanges, comply with § 1557? 2016 215 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? the supreme court, in grove city college v. bell, spoke on the scope of the coverage of antidiscrimination statutes.93 recall that grove city college was the case in which a college did not want to comply with antidiscrimination regulations in order to be able to utilize federal funds for its students.94 the court found that the department of education had the authority to withdraw the student educational funding because grove city college received federal financial assistance through that student funding.95 however, the court noted that only the specific funding program that received the federal financial assistance was subject to regulation and not grove city college as a whole.96 essentially, the court took a very narrow approach to “program or activity.” under this approach, if an institution were to receive “federal financial assistance,” only the specific part of the institution that received that assistance would be subject to antidiscrimination regulations, not the institution as a whole in every aspect of its business. but this narrow reading by the court does not negatively affect the current situation being analyzed. here, a health insurance company receives federal financial assistance through premium subsidies. according to grove city college, the antidiscrimination scrutiny must be “program specific.”97 however, this does not mean scrutiny is extended only to the plan which triggered the premium subsidy but rather that scrutiny is extended to the entire program of the health insurance company which provides health plans. this is so because no case law has taken “program specific” to the extreme of meaning “individually specific.” for example, in u.s. v. baylor university medical center, the court sought to determine whether and to what extent medicare and medicaid payments subjected a hospital to the scrutiny of § 504 of the rehabilitation act.98 the court first determined that medicare and medicaid payments qualified as “federal 93 grove city college v. bell, 465 u.s. 555 (1984). 94 id. at 561. 95 id. at 575-576. 96 id. at 570-571. 97 id. 98 u.s. v. baylor university medical center, 736 f.2d 1039, 1040 (1984). 216 indiana health law review vol. 13:1 financial assistance.”99 then the court sought to determine whether the antidiscrimination scrutiny applied to the hospital as a whole or to just the inpatient emergency room services that led to the medicare and medicaid payments in the first place.100 the court held that the hospital’s inpatient and emergency room services were subject to antidiscrimination scrutiny, but that the entire hospital as a whole was not because of the “program specific” requirement.101 notice that the court did not say that only the specific individuals who caused the medicare and medicaid payments to be made to the hospital were subject to scrutiny, but rather all inpatient and emergency room services. in the current situation, it would not just be the specific, individual plan that will be subject to § 504 – and thus § 1557 – scrutiny, but rather the entire program that deals with insurance plans. so while only some plans will trigger the premium subsidies that make the insurance companies recipients of federal financial assistance, all plans which said company provides will likely be subject to § 1557. e. other means of § 1557 coverage while the premium tax credits system will likely serve as the broadest means by which a health insurance company can be subject to § 1557 regulation, there are other means. first, executive agencies and any other entities established under the aca are subject to § 1557 regulation.102 second, medicare and medicaid payments will also trigger § 1557 regulation.103 and lastly, health insurance companies that do not offer plans through the exchanges can receive “federal financial assistance” in a variety of other ways outside of premium tax subsidy payments, thus making them subject to § 1557 regulation. with all of these various means by which health insurance companies can qualify as covered entities under § 1557, the vast majority of health insurance plans in the united states should be subject to § 1557. 99 id. at 1048-1049. 100 id. at 1049. 101 id. 102 42 u.s.c. § 18116(a) (2015). 103 u.s. v. baylor university medical center, 736 f.2d 1039, 10481049 (1984). 2016 217 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? iv. high tiering and step-therapy and preauthorization requirements: discriminatory and prohibited under § 1557? in order to determine whether § 1557 will be effective at ending health insurers’ practices of high tiering and steptherapy and pre-authorization requirements for individuals with hiv/aids, it must be determined both what type and what mode of discrimination § 1557 prohibits. the “type” of discrimination will refer to what basis discrimination is prohibited on. the “mode” of discrimination will refer to the method of discrimination: either intentional or disparate impact.104 then it must be determined whether high tiering and step-therapy and pre-authorization requirements constitute such prohibited discrimination under § 1557. since § 504 of the rehabilitation act is the relevant antidiscrimination statute invoked by § 1557 in terms of hiv/aids discrimination, this discussion will be based on § 504. a. what type of discrimination is prohibited by § 1557? section 1557 prohibits discrimination “on the ground prohibited under . . . section 504 of the rehabilitation act.”105 section 504 of the rehabilitation act prohibits discrimination on the basis of disability.106 the supreme court has held hiv/aids to be a disability.107 therefore, § 1557 prohibits discrimination on the basis of hiv/aids status. but presently, the aforementioned insurance practices are not explicitly based on the forbidden criterion hiv/aids. while disability is a forbidden criterion on which 104 disparate impact discrimination occurs when “practices that are facially neutral in their treatment of different groups . . . in fact fall more harshly on one group than another.” smith v. city of jackson, 544 u.s. 228, 239 (2005). 105 42 u.s.c. § 18116(a) (2015). 106 29 u.s.c. § 794(a) (1973). 107 e.g., bragdon v. abbott, 524 u.s. 625, 630-647 (1998) (ada); doe v. county of centre, pa., 242 f.3d 437, 447 (3d cir. 2001) (rehabilitation act); chalk v. united states dist. ct., 840 f.2d 701, 704-709 (9th cir. 1988) (rehabilitation act). 218 indiana health law review vol. 13:1 to discriminate and hiv/aids is a disability, high tiering and step-therapy and pre-authorization requirements do not technically apply directly to individuals with hiv/aids but rather apply to the hiv/aids drugs themselves. so the question becomes: is discrimination targeted at hiv/aids medications the same as discrimination against individuals with hiv/aids? in lawrence v. texas, the supreme court held that a same-sex sodomy law discriminated against homosexuals because it targeted conduct that was closely tied with being homosexual.108 the court concluded “there can hardly be more palpable discrimination against a class than [targeting] the conduct that defines that class.”109 here, insurance companies have not targeted conduct that technically defines the class, individuals with the disability of hiv/aids; however, the insurance companies have targeted conduct that is closely tied to the class. indeed, the taking of hiv/aids medications is absolutely necessary for someone with the disease in order to stay alive. however, same-sex sodomy is not absolutely necessary for homosexual individuals to stay alive. so, same-sex sodomy is actually less linked with being a homosexual than taking hiv/aids medications is with being an individual with hiv/aids. therefore, targeting hiv/aids medications seems equivalent to targeting individuals with hiv/aids. in sum, § 1557 prohibits discrimination based on hiv/aids status, and that prohibition extends to discrimination based on hiv/aids medications because of the extremely close link between having hiv/aids and the necessity for taking hiv/aids drugs. b. intentional discrimination: prohibited? in order to determine whether the three aforementioned insurance practices are prohibited by § 1557 as intentional discrimination, it must first be determined whether § 1557 actually prohibits intentional discrimination. the supreme court has spoken as to what discrimination qualifies as a 108 see lawrence v. texas, 539 u.s. 558, 583 (2003). 109 id. 2016 219 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? violation of § 504 of the rehabilitation act. indeed, in alexander v. choate, the supreme court interpreted § 504 of the rehabilitation act.110 the court was not even concerned as to whether § 504 prohibits intentional discrimination; it took that for granted.111 the court used intentional discrimination as a starting point, or a floor, for § 504.112 the issue, in the court’s opinion, was not whether § 504 prohibits intentional discrimination but whether it prohibits disparate impact discrimination.113 from alexander v. choate, it is clear that § 504 prohibits intentional discrimination. indeed, if it did not, the provision would be meaningless. intentional discrimination is the most blatant and most basic form of discrimination. if intentional discrimination is not prohibited by § 504, then no discrimination is prohibited and the law is useless. c. high tiering and step-therapy and pre-authorization requirements: intentional discrimination? 1. preliminary question 1: are these three insurance practices discriminatory to begin with? discrimination is not defined in § 1557. however, courts have traditionally found “discrimination” to mean differential treatment based on a forbidden criterion.114 since it is apparent that individuals with hiv/aids – which is a disability and therefore a forbidden criterion – are being targeted by these practices, it must be determined whether these practices constitute differential treatment. high tiering, step-therapy and pre-authorization requirements seem to constitute differential treatment. these practices deny meaningful coverage to individuals with hiv/aids and do not occur with other individuals. when an insurer places all or most of the effective hiv/aids drugs on the highest cost-sharing tiers of their 110 alexander v. choate, 469 u.s. 287 (1985). 111 id. at 292. 112 id. 113 id. at 292-293. 114 see jackson v. birmingham bd. of educ., 544 u.s. 167, 174 (2005); rene v. mgm grand hotel, inc., 305 f.3d 1061, 1067 (9th cir. 2002). 220 indiana health law review vol. 13:1 prescription drug formularies, it makes those drugs virtually unaffordable.115 this leaves individuals with hiv/aids only able to afford either ineffective or toxic generic hiv/aids medications. if an individual with hiv/aids does still try to go the route of taking the overly expensive hiv/aids on the high tiers, they often cannot afford those medications on a monthly basis, causing the extremely dangerous interruptions in treatment the medical standard of care seeks to avoid.116 step-therapy and pre-authorization requirements only add to the likelihood of treatment interruption. step-therapy requirements require individuals to take less effective and potentially toxic generic drugs before moving on to the brand-name drugs that are actually effective.117 individuals with hiv/aids subjected to steptherapy requirements are really experiencing an interruption in treatment since their hiv/aids is not being effectively treated but allowed to replicate and mutate. finally, pre-authorization requirements also cause interruptions in treatment. since an individual subjected to a pre-authorization requirement must obtain permission from his or her insurer before every refill of their medication, there are often delays in obtaining the refill for the medication, leading to dangerous interruptions in treatment. these insurance practices cause effective hiv/aids drugs to be virtually unaffordable and cause dangerous interruptions in treatment. therefore, these insurance practices cause the plans to be effectively useless to individuals with hiv/aids, as opposed to individuals without the disease. since individuals without hiv/aids do not need hiv/aids medications, these plans would be more favorable for individuals without the disease. this has the effect of discouraging individuals with hiv/aids from enrolling in these plans; but since individuals without hiv/aids do not require hiv/aids medication, these practices have no discouraging effect on individuals without hiv/aids. this is the differential treatment constituting discrimination. 115 yates, supra note 31, at 16; aids found. of chi., supra note 31; andrews, supra note 31. 116 yates, supra note 31, at 15. 117 yates, supra note 31, at 2; see aids found. of chi. supra note 31; hiv health care access working group, supra note 34. 2016 221 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? 2. preliminary question 2: do insurance companies have autonomy in choosing to adhere to these practices? before moving on to inquire as to whether the discrimination was intentional, another important point must be made. it seems obvious that that portion of insurers that adhere to the aforementioned practices do so intentionally. there is no law requiring these practices, and the practices were not written into the plan by accident. each company designs its own prescription drug formularies and decides whether to institute step-therapy and preauthorization requirements for hiv/aids drugs. when an insurer places all or most effective hiv/aids drugs on the highest tiers of a prescription formulary and institutes steptherapy and pre-authorization requirements, it does so intentionally and not by market force. note that it is not being said that these practices are intentionally discriminatory, but merely that they are intentionally put into place. basically, insurance companies cannot say that they have no other choice than to implement these practices; they cannot say that there is no discriminatory intent because they simply did not want to implement these practices in the first place. if they did not want to or intend to implement these practices, they simply would not have done so. 3. are health insurance companies that are adhering to these practices exhibiting intentional discrimination? one can see that these insurance practices are discriminatory and that they are being implemented intentionally, but the big question here is whether this discrimination is intentional. how does one define intentional discrimination? in lovell v. chandler, a group of disabled individuals brought a class action under § 504 of the rehabilitation act against the state of hawaii alleging that they had been declared ineligible for hawaii’s “quest” 222 indiana health law review vol. 13:1 medical coverage solely based on their disabilities.118 in 1994, hawaii developed this “quest” program in order to provide health insurance to more of its low-income citizens.119 hawaii explicitly and categorically excluded individuals who were over 65 years old, blind, or disabled.120 for an award of compensatory damages, the court needed to determine whether the state of hawaii had intentionally discriminated against plaintiffs.121 the court stated that an entity exhibits discriminatory intent – intentional discrimination – when it is “deliberate[ly] indifferen[t].”122 the court went on to say that “[d]eliberate indifference requires both knowledge that a harm to a federally protected right is substantially likely, and a failure to act upon that likelihood.”123 it continued, “the first element is satisfied when the . . . entity has notice that an accommodation is required. the second element is satisfied if the entity’s ‘failure to act [is] a result of conduct that is more than negligent, and involves an element of deliberateness.”124 furthermore, an entity “at the very least” exhibits “deliberate indifference” when facial discrimination is present because “by its very terms, facial discrimination is ‘intentional.’”125 the court reasoned that because hawaii had categorically excluded disabled individuals from the program when it knew that doing so would mean some of those individuals would ultimately go without coverage altogether, it did not act with enough care to protect the rights of its disabled citizens.126 it also stated that hawaii had facially discriminated against disabled individuals in the quest program.127 for these reasons, the court found that hawaii 118 lovell v. chandler, 303 f.3d 1039, 1044 (9th cir. 2002), cert denied, 537 u.s. 1105 (2003). 119 id. at 1045. 120 id. 121 id. at 1056. 122 id. 123 id. (quoting duvall v. cnty. of kitsap, 260 f.3d 1124, 1139 (9th cir. 2001). 124 id. 125 id. at 1057. 126 id. 127 id. 2016 223 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? had exhibited “deliberate indifference” and therefore intentional discrimination in the design of its quest program.128 it appears that the insurance companies that adhere to these practices are exhibiting “deliberate indifference” and are therefore intentionally discriminating. as described above, when discrimination is of the type described as facial discrimination, it is per se deemed to be intentional discrimination. it seems that is the type of discrimination at play here. it is not the case that there is some other criteria that is being used and these drugs are disproportionately affected by it. the companies that adhere to these practices are explicitly designating hiv/aids medications for high tiering and step-therapy and pre-authorization requirements. therefore, this discrimination seems facial and thus intentional. on the other hand, this discrimination might be viewed as not being facial simply because it does target the hiv/aids drugs and not individuals with hiv/aids themselves. however, as was previously explained, targeting hiv/aids drugs is the equivalent of targeting individuals with hiv/aids themselves. so the argument in favor of these practices constituting facial discrimination—and thus intentional discrimination—seems to remain strong. indeed, the present situation is much like that in lovell. just as hawaii had explicitly and categorically provided in its laws that the quest program excluded disabled individuals, some insurance companies are explicitly providing that these overly burdensome practices only apply to hiv/aids medications—thus effectively only to individuals with hiv/aids. if these practices are not considered to be intentional discrimination under this sort of per se facial discrimination standard, they likely will be under the two-pronged “deliberate indifference” test laid out by the court in lovell. recall that “[t]he first element [of deliberate indifference] is satisfied when the . . . entity has notice that an accommodation is required.129 here, all insurance companies 128 id. 129 id. at 1056. 224 indiana health law review vol. 13:1 are undoubtedly aware of the aca’s requirements. therefore, all insurance companies know that the aca makes an accommodation for individuals with a preexisting condition—here, hiv/aids—such that they may not be denied coverage or charged higher rates for such coverage than individuals without the preexisting condition.130 all insurance companies in the united states are aware of this aca requirement. actually, the mere fact that they are allowing individuals with hiv/aids to enroll in their plans and are not charging them higher baseline rates than individuals without a preexisting condition proves they are aware of the accommodation required by the aca. before the aca, insurers would not have let individuals with hiv/aids enroll on their plans. if they did, they would charge them grossly higher baselines rates. these companies must be aware that an accommodation is required. another similarity to lovell arises here. insurance companies are effectively denying individuals with hiv/aids coverage. in lovell, the court stated that the fact that hawaii had discriminated against disabled individuals meant it was charged with notice that federal protection may apply and an accommodation required.131 here, since insurance companies are discriminating against disabled individuals, they are on notice that an accommodation may be required. moving on, recall that “[t]he second element [of deliberate indifference] is satisfied if the entity’s ‘failure to act [is] a result of conduct that is more than negligent, and involves an element of deliberateness.’”132 here, the insurance companies adhering to these practices did not fail to act; rather, they acted affirmatively to deny individuals with hiv/aids the required accommodation. if a “failure to act” beyond that which is negligent constitutes deliberateness, an affirmative action surely qualifies. here, one might think that these insurance companies are actually complying with the aca’s required accommodation because said companies are allowing individuals with hiv/aids to enroll in their plans and are not charging them higher baseline premiums. 130 42 u.s.c. § 300gg-4 (2015). 131 lovell v. chandler, 303 f.3d at 1057 (emphasis added). 132 id. at 1056, (quoting duvall v. county of kitsap, 260 f.3d 1124 (9th cir.2001)). 2016 225 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? this would be true if the insurers had not gone a step further and implemented these three practices. however, high tiering, step-therapy, and pre-authorization requirements effectively deny enrollment, or, at the very least, deny equivalent cost for the plans to individuals with hiv/aids. it is not just the case that these insurance companies’ failure to act caused the denial of the required accommodation; it is the case that their affirmative action caused such a denial. both prongs of the “deliberate indifference” test being fulfilled, and “deliberate indifference” constituting intentional discrimination, insurance companies that adhere to these three practices seem to be exhibiting intentional discrimination as prohibited under § 504 of the rehabilitation act – and thus § 1557 of the aca. that the health insurance companies adhering to these practices are exhibiting intentional discrimination makes sense intuitively as well. for insurance companies to be most profitable, they seek to insure as many low-risk, low-payout people as possible. however, the aca, via the guaranteed issue and community rating requirements, keeps insurers from explicitly discriminating against individuals with hiv/aids in order to keep their groups low-risk, low-payout. nonetheless, insurers still have motive to keep their groups low-risk and low-payout. since hiv/aids patients are highrisk and high-payout, insurers want to insure as few of these individuals as possible. with this motive in mind, and such prohibitive and restrictive practices instituted by insurance companies against individuals with hiv/aids, the discrimination seems likely to be intentional. what other reason would insurance companies have to institute these practices? it is obvious that these practices go against the medical standard of care for treating hiv/aids. furthermore, step-therapy and pre-authorization requirements are not always cost-saving methods for insurance companies. this is because of their aptitude to cause interruptions or delays in treatment. these lapses in treatment allow the virus to grow, mutate, and continue to attack the immune system.133 when this happens, the human immune system is obviously severely weakened; and 133 dep’t of health & human servs., supra note 44, at 188. 226 indiana health law review vol. 13:1 when this happens, individuals often have to be hospitalized.134 such hospitalizations are extremely costly episodes of care.135 the insurer ends up paying for these ineffective drugs, and then also pays—an exorbitant amount—for the hospitalization due to the interruption in effective treatment. it is easy to see how these practices could actually end up being more expensive for insurance companies. the high tiering of hiv/aids drugs on prescription drug formularies is not always costsaving either, for two reasons. first, the interruptions these tierings cost inevitably leads to the proliferation of the hiv/aids virus and subsequent costly hospitalization. second, these formularies often place the individual components of the str drugs – that are on the highest tiers – on the lower tiers in small doses.136 if individuals with hiv/aids choose to go this medicallyunsafe route of purchasing all of the components of the strs separately and in a large quantity—since each component is only on a lower cost-sharing tier in smaller doses—the cost to the insurance company can actually increase as compared to the str on the highest tiers. insurance companies are just that, companies. companies want to maximize profit. so why would they institute these practices that would not be cost-saving or even end up costing them more money? the answer is simple. these practices are actually cost-saving, although not in the way they are claimed to be. they are cost saving in that they discriminate against individuals with hiv/aids. these practices make health plans overly financially burdensome and medically unsafe, which works to discourage individuals with hiv/aids from enrolling in 134 see generally nancy crum, trends and causes of hospitalizations among hiv-infected persons during the late haart era: what is the impact of cd4 counts and haart use?, 54(3) j. acquir. immune defic. syndr. 248 (2010). 135 michael carter, hiv treatment is costly, especially for the sickest patients, aidsmap (sept. 27, 2010), http://www.aidsmap.com/ hiv-treatment-is-costly-especially-for-the-sickest-patients/page/ 1516347, [http://perma.cc/w6v4-acfz]. 136 elizabeth taylor, aca discrimination against people with hiv/aids will not be tolerated, huffington post, (jun. 6, 2014), [http://www.huffingtonpost.com/elizabeth-taylor/aca-discriminationagainst-hiv_b_5511810.html, [http://perma.cc/a5px-5dc]. http://dx.doi.org/10.1097/qai.0b013e3181c8ef22 2016 227 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? them. thus, the insurance companies get what they want: less people with hiv/aids on their plans. they are intentionally discriminating against individuals with hiv/aids to keep such individuals off of their plans, which saves money for the insurer. overall, it seems that if these insurance practices are not found to be intentionally discriminatory under § 504 of the rehabilitation act, and thus § 1557 of the aca, then intentional discrimination is a breathtakingly narrow and rather useless standard. d. disparate impact discrimination: prohibited? in order to determine whether these insurance practices are prohibited by § 1557 as disparate impact discrimination, it must first be determined whether § 504 of the rehabilitation act – which § 1557 invokes – actually prohibits disparate impact discrimination. in alexander v. choate, the state of tennessee planned to reduce the number of inpatient hospital days per year that state medicaid would pay hospitals for a medicaid beneficiary’s hospitalization.137 a group of medicaid recipients filed a class action suit seeking declaratory and injunctive relief.138 plaintiffs alleged that the reduction in days of coverage violated § 504 of the rehabilitation act because it negatively and disproportionately affected the handicapped. the court opined that “much of the conduct that congress sought to alter in passing the rehabilitation act would be difficult if not impossible to reach were the act construed to proscribe only [intentional discrimination].”139 the court refused to hold that § 504 proscribes disparate impact broadly as a general rule in all cases.140 the court’s refusal to do so seemed to be fueled by a fear of a “boundless” and overly broad cause of action in § 504.141 however, the court concluded that § 504 can proscribe disparate impact 137 alexander v. choate, 469 u.s. 287, 289 (1985). 138 id. 139 id. at 296-297. 140 id. at 299. 141 id. 228 indiana health law review vol. 13:1 discrimination in some cases,142 such as when a “[disabled] individual [is not] provided with meaningful access to the benefit that [is] offer[ed].”143 while “fundamental” or “substantial” modifications to the program or benefit are not required, “reasonable” modifications are required.144 in fact, “under some circumstances, a refusal to modify an existing program might become unreasonable and discriminatory.”145 the court found that tennessee’s reduction in coverage days did not violate § 504.146 the court reasoned that the reduction did not disproportionately affect handicapped individuals but affected both handicapped and nonhandicapped individuals equally.147 so although the court did not find disparate impact discrimination to have been present in alexander v. choate, it did recognize that § 504 prohibits disparate impact discrimination in certain cases. e. high tiering and step-therapy and pre-authorization requirements: disparate impact discrimination? with this legal framework in mind, it can now be determined whether high tiering and step-therapy and preauthorization requirements qualify as disparate impact of the kind prohibited under § 504 of the rehabilitation act – and thus § 1557 of the aca. the present situation is different from that in alexander v. choate. in alexander v. choate, the reduction in coverage days was not disparate impact discrimination because it affected both handicapped and non-handicapped individuals equally since both groups of people needed equal access to hospitalization. however, in the current situation, only individuals with hiv/aids need access to hiv/aids medications. therefore, these aforementioned insurance practices that drastically limit access to hiv/aids medications negatively affect individuals with hiv/aids whereas it does not negatively affect those without the 142 id. 143 id. at 301. 144 id. at 300. 145 id. (citing southeastern community college v. davis, 442 u. s. 397 (1979)). 146 id. at 309. 147 id. 2016 229 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? disease; in other words, it disproportionately affects individuals with hiv/aids. this is disparate impact discrimination. so it is clear that disparate impact discrimination is at play here. however, recall that § 1557, through § 504 of the rehabilitation act, does not extend to all disparate impact discrimination, but only such discrimination that denies individuals with a disability “meaningful access” to the benefit offered.148 in this case, that is exactly what is happening. insurance companies are offering the benefit of health insurance coverage for medications. however, because high tiering and step-therapy and pre-authorization requirements cause hiv/aids medications to be unaffordable and cause dangerous interruptions in treatment, they effectively deny individuals with hiv/aids the benefit of insurance coverage for their medications. these practices are such that an individual with hiv/aids cannot effectively manage and treat their condition, causing the plans that subscribe to such practices to be inaccessible to those with hiv/aids. so individuals with hiv/aids are being denied the very benefit that is being offered to them – health insurance coverage for their medications and treatment. such individuals are being denied meaningful access to the benefit at issue. this is precisely the form of disparate impact discrimination that the court in alexander v. choate explained that the law prohibits. furthermore, insurance companies that subscribe to these practices need only modify their plans to a “reasonable” degree; a “substantial” or “fundamental” change in the program is not necessary.149 hiv/aids medications need only be dropped down to lower tiers. while these insurers may argue that this would cost too much money, it is obviously not financially debilitating considering that some insurance companies already have such medications on lower, more affordable tiers.150 surely these other companies 148 id. at 301. 149 id. at 300. 150 see aids found. of chi., cost of hiv medications in the illinois health insurance marketplace (march 13, 2014) (on file with the aids found. of chi.), available at http://www.aidschicago.org/resources/ content/1/4/documents/afc-il-marketplace-hiv-med-coverage-2015.pdf/ [http://perma.cc/t4pk-3l78]. 230 indiana health law review vol. 13:1 are not operating at a loss by putting these hiv/aids mediations on lower tiers; if such a formulary structure were to cause a loss, these companies would not have such formularies. the step-therapy and pre-authorization requirements would need to be completely abolished. while at first blush this may seem to be a “substantial” or “fundamental” modification, it is not. again, this is because other companies do not impose these requirements and they are not operating at a loss. operating without these requirements is feasible and reasonable. furthermore, it is not an unreasonable modification for insurers to alter or even completely dispose of practices whose sole purpose is to discriminate and discourage qualified individuals from enrolling. overall, high tiering, step-therapy, and preauthorization requirements seem to constitute the very sort of disparate impact discrimination that § 504 of the rehabilitation act – and thus § 1557 of the aca – was interpreted by the supreme court to prohibit. v. a policy consideration with such a new, expansive, and unprecedented law as the aca, it is wise to take a step back and at least briefly look at some of the policy considerations that may affect this situation and that courts may factor in to a decision. section 1557 does not exist in vacuo but lives within the broader context of the entire aca and indeed the entire health insurance market. in the introduction to this note the key pieces of the aca were briefly explained. the following is an explanation about how some of those pieces interact to keep the aca afloat. the guaranteed issue and the community rating requirements ensure that everyone, regardless of their health status or history, is functionally able to obtain health insurance at relatively similar rates.151 however, if this were all the aca did, health insurance rates overall would skyrocket because of all of the high-risk people entering the 151 joel e. miller, healthcare reform: the “three-legged stool” of health insurance reform under the aca, amhca (oct. 1, 2013), http://www.amhca.org/news/detail.aspx?articleid=717 [http://perma.cc/ u66c-zjn4]. http://www.amhca.org/news/detail.aspx?articleid=717 2016 231 section 1557 of the affordable care act: an effective means of combatting health insurers’ discrimination against individuals with hiv/aids? market.152 however, the individual mandate, in a sense, forces most americans to buy insurance and thus participate in the health insurance market.153 this brings low-risk individuals into the market to counterbalance the high-risk individuals and thus reduces the cost of insurance.154 finally, the premium tax credits subsidize the cost of the insurance from lowand middle-income individuals so that it is actually feasible for them to afford the health insurance the individual mandate requires them to buy.155 this is the “three-legged stool” of the aca; abolish or damage any one of these provisions and the aca cannot stand.156 we have seen that insurance companies are trying to find ways to keep out high-risk individuals —individuals with a preexisting condition—even though the aca prohibits such practices.157 if these practices, such as high tiering, steptherapy, and pre-authorization requirements, go unchecked, it will functionally undo the key provisions of the aca that provide for the guaranteed issue and the community requirements. without that leg of the stool, the aca will fall.158 one of the aca’s largest purposes will go unfulfilled. therefore, it is imperative that § 1557 be given broad scope and considerable teeth to combat these discriminatory practices and close the back door the health insurance companies have been using to elude the guaranteed issue and community rating requirements. the supreme court has already seemed willing to interpret portions of the aca so that they may stand and have effect, even if not as originally intended, as opposed to completely gutting them.159 so there is some hope that the courts will interpret § 1557 favorably in upcoming cases in order to keep the aca intact and thus keep millions of people insured. 152 id. 153 id. 154 id. 155 id. 156 id. 157 andrews, supra note 30. 158 miller, supra note 151. 159 see nat’l fed’n of indep. bus. v. sebelius, 132 s.ct. 2566, 2580 (2012). 232 indiana health law review vol. 13:1 vi. conclusion most of the health insurance companies in the united states will be covered entities under, and thus be subject to, the regulation of § 1557. section 1557 prohibits intentional and certain forms of disparate impact discrimination against individuals with hiv/aids. the three health insurance practices described in this note likely qualify as the intentional discrimination prohibited by § 1557 and even more likely qualify as the disparate impact discrimination prohibited by § 1557. policy also weighs in favor of § 1557 prohibiting these insurance practices. therefore, § 1557 should serve as an effective means to combat discrimination by health insurance companies against individuals with hiv/aids in the form of the high tiering of hiv/aids medications on prescription drug formularies and steptherapy and pre-authorization requirements. julie d. cantor julie cantor holds ba and ma degrees in psychology from stanford univer­ sity. after graduating from stanford, julie pursued her long-standing interest in medical ethics by serving as research associate at the university of california, san francisco's program in medical ethics. she continued her education at yale law school and the university of california at berkeley's boalt hall school of law, where she received her jd. julie graduated from the yale university school of medicine in may of2005. during her time at yale, she taught two undergraduate seminars that she created as a lecturer at yale college entitled, ''the stork in the 21st century: reproduction, medical ethics, and the law," and "medical ethics, law, and literature." julie has lectured on topics at the intersection of law and medicine at universities around the country, and her writing has appeared in national medical and legal publications. of pills and needles: involuntarily medicating the psychotic inmate when execution looms julie d. cantor, m.d. 'the path i tread will lead me either to madness or to execution .... " don carlos, crown prince of spain, in friedrich schiller's play don carlos1 introducfion on a warmsummereveningin 1979,2 charles laverne singleton walked into york's grocery, a local convenience store in the tiny arkansas town of hamburg,3 with a .25 caliber pistol in hand and robbery in mind.4 owner mary lou york, a 62-year-old mother of four, was minding the store from behind the check-out counter.' singleton walked up to her and asked for some cigarettes. 6 when she moved to grab a pack, singleton took out his gun, announced that he was robbing her and that he wanted all of the money in the cash register. 7 but york was no easy mark. as john frank gibson, the former ashley county prosecutor who tried singleton, recalled, ''she was the type of person who would protect her belongings. she was not going to be pushed around by anybody."8 when york fought back, singleton fired his gun at her.9 he missed.10 undeterred, he took out a rusty knife and attacked again, stabbing york twice 1. friedrich schiller, don carlos and mary s1uart 280 (peter oswald, trans., oxford univ. press 2002) (1787). 2. the mean temperature in north little rock, arlamsas was 72.5 degrees f on june 1, 1979, the day of the murder. the old farmer's almanac, weather: weather history for one day, at http :1/www .almanac.com/weatherhistory/oneday .php? number=723400&day=l&month=6&year=l979 (last visited apr. 17, 2005) (on file with the indiana health law review). singleton v. norris, 319 f .3d 1018, 1020 (8th cir. 2003)(noting that the crime occurred on june 1, 1979 at approximately 7:30p.m.). 3. hamburg's population hovers near 3000. united states city facts, facts about hamburg, arkansas, at http://www.uscityfacts.com/city.htm?state=arkansas&city=hamburg oast visited apr. 17, 2005) (on file with the indiana health law review). 4. dateline nbc: crazy like a fox?; an insane death row inmate becomes the center of a legal debate when he refuses to take his medication to avoid being executed (nbc television broadcast, apr. 5, 1999) [hereinafter dateline nbc: crazy like a fox?]. 5.id. 6.id. 1.ld. 8.ld 9. dateline nbc: crazy like a fox?, supra note 4. io.id. 120 indiana health law review [vol. 2:117 in the neck11 as she screamed, "charles singleton is killing me[!]"12 with a small amount of cash in tow, 13 singleton left his wounded victim behind. police officers soon arrived, and an ambulance scooped up the bleeding york. she .felt that her death was imminent. . as she told one of the officers, "[t]here' s no way i can be all right[;] you know i'm not going to make it. i've losttoo much blood."14 she was right. she died en route to the hospital. it was an inelegant crime, and singleton's culpability was undeniable. damning eyewitness testimony, his own bloodstained clothing, york's excited utterance during the crime and her dying declaration on the way to the hospital were convincing. 15 singleton also led police to the weapons he used that night, and he told them, "i stabbed her. i remember doing it."16 as the arkansas supreme court remarked, ''the evidence of guilt in this case is over­ whelming."17 prosecutor gibson concurred. "with regard to the guilt," he remembered, "it was pretty open and shut."18 a jury convicted singleton of aggravated robbery and felony murder, and the court sentenced him to life imprisonment and death, respectively, for his crimes. the arkansas supreme court affirmed the capital murder convic­ tion and sentence,19 and the state set an execution date for june 4, 1982.20 singleton again appealed and was granted a temporary stay of execution.21 that decision marked the beginning of an epic journey through the appellate court system, from the state courts of arkansas22 to the eighth circuit court of appeals23 to the united states supreme colll'f4 and back again; 25 11. id 12. singleton v. state, 623 s.w.2d 180, 181 {ark. 1981) (detailing facts of the case). 13. singleton stole $69. dateline nbc: crazy like a fox?, supra note 4. 14. singleton, 623 s.w.2d at 181. 15. id 16. dateline nbc: crazy like a fox?, supra note 4. 17. singleton, 623 s.w.2d at 181. 18. dateline nbc: crazy like a fox?, supra note 4. 19. singleton v. state, 623 s.w.2d 180(ark.198l)(affirmingsingleton'sconvictionand sentence for capital felony murder, but setting aside the aggravated robbery conviction on double jeopardy grounds). 20. singleton v. norris, 319 f.3d 1018, 1021 (8th cir. 2003). 21. singleton v. lockhart, 653 f. supp. 1114, 1115 (b.d. ark. 1986), rev'd and remanded, 871 f.2d 1395 (8th cir. 1989) (noting that on "june 1, 1982, this court granted petitioner a stay of execution and petitioner's first petition for writ ofhabeas corpus was filed."). after hearing the case, the district court vacated the death sentence and imposed a penalty oflife without parole. ld at 1138. · the eighth circuit reversed that decision. 22. see, e.g., singleton v. state, 623 s.w.2d 180 (ark. 1981); singleton v. endell, 870 s.w.2d 742 (ark. 1994). 23. see, e.g., singleton v. lockhart, 871 f .2d 1395 (8th cir. 1989)(affirming the district court's denial of a petition for habeas corpus, reversing the portion. of the order that vacated singleton's death sentence, and remanding to reinstate that penalty). 24. singleton v. norris, 506 u.s. 964 (1992)(denyingthe petition for writ of certiorari). · 25. singleton v. norris, 540 u.s. 832 (2003) (denying the petition for writ of certiorari). 2005] involuntarily medicating the psychotic inmate 121 singleton's appeals generally involved issues that fell squarely within the purview of criminal law-the trial judge erred when he failed to excuse prospective jurors for cause;26 the state violated rules of evidence;27 singleton's lawyer was ineffective.28 but by 1998, the issue had changed to one that involved medicine, ethics, and law. 29 a. descent into psychosis the record is clear that at the time of the crime, singleton was not suffering from an appreciable mental illness. in 1979, at the insistence of his attorney, singleton underwent psychological and psychiatric testing at arkansas state hospital. 30 mental health professionals diagnosed him with severe antisocial personality disorder and habitual excessive drinking, and they pegged his iq at eighty-three, placing him in "the dull normal range of intellectual functioning. "31 but, they noted, he was not "overtly psychotic or out of contact with reality at this time'' and "probably was not at the time of the commission of the alleged offense. "32 singleton, they found, understood the proceedings against him and could assist his attorney, and he failed to qualify for an insanity defense. 33 on appeal, he argued that the trial court erred when it allowed him to waive his right to present mitigating evidence at the sentencing phase of his trial, and he lost-the eighth circuit court of appeals found that his mental state at the time of the waiver was adequate. 34 as that court explained, "there is no question but that singleton was not laboring under any mental disability that would call into question his com­ petence to knowingly and intelligently waive his right to present mitigating evidence."35 26. singleton v. state, 623 s.w.2d 180, 181 (ark. 1981). 27. singleton, 623 s.w.2d at 182. 28. singleton v. lockhart, 653 f. supp. 1114, 1116 (e.d. ark. 1986). 29. singleton v. norris, 964 s.w.2d 366 (ark. 1998). 30. singleton v. lockhart. 962 f.2d 1315, 1318 (8th cir. 1992) (discussing the psycho­ logical and psychiatric testing of singleton that occurred at the time of the trial). 31. singleton, 962 f.2d at 1318. 32. id still, when singleton recounted his state of mind at the time of the crime during a 1999 interview, he failed to sound completely rational. his take on killing york and what he would say to her family: that's very difficult. but i'm sorry i took a life, but it was not their mother whose life i was involved with. i was in a different reality and the person i was slaying was mary from the mother of jesus in the bible. that's the reality i was in, because i was in 8-il religious state of mind, something like, you've ever seen that show, 'millennium'? ... it was-it was about religion, but it wasn't reality. dateline nbc: crazy like a fox?, supra note 4. of course, singleton's state of mind at the time of that interview may have colored his recollection of the past. 33. singleton, 962 f.2d at 1317-21 (recounting the trial specifics). 34. id. at 1318. 35. id at 1322. 122 indiana health law review [vol. 2:117 during his incarceration, though, singleton's behavior changed. early on, physicians treated him with medication for anxiety and depression. 36 by 1987, his mental clarity deteriorated and symptoms of severe mental illness emerged. he believed that demons possessed his cell and that "demon blood" stained its walls. he lost weight. he experienced hallucinations ("that his brother would come to his locked prison cell and take him out of it for walks") and. delusions ("that a prison doctor had planted some type of device in his right ear and that his thoughts were being stolen from him when he read the bible"). arkansas correctional facility physicians diagnosed him with para­ noid schizophrenia37 and administered antipsychotic medication to control his symptoms.38 at first, singleton took those medications voluntarily.39 but from time to time, he refused to take them. 40 during those unmedicated 36. singleton v. norris. 319 f.3d 1018, 1030 (8th cir. 2003) (heaney, j., dissenting). the facts recounted in this paragraph that relate to singleton's psychotic behavior are compiled from this dissenting opinion. 37. the diagnostic and statistical manual of mental disorders is the definitive text that lists diagnostic criteria for mental disorders. for a diagnosis of schizophrenia, the patient must first exhibit "[t]wo (or more) of the following. each present for a significant portion of time during a 1-month period (or less if successfully treated): (l) delusions (2) hallucinations (3) disorganized speech (e.g., frequent derailment or incoherence) (4) grossly disorganized or catatonic behavior (5) negative symptoms, i.e., affective flattening, alogia, or avolition." am.psycidatricass'n,diagnosticandstatisticalmanualofmentaldisorders:text revision 298-312 (4th ed. 2000). second, the patient needs to demonstrate social or occupational dysfunction, such as difficulty with work, interpersonal relations, or self-care. these difficulties must persist for at least 6 months. further, the disorder must not be due to a schizoaffective or mood disorder, and it may not stem from medications, street drugs, or other exogenous sources. !d. at 298-312. paranoid schizophrenia is a subtype of the disorder, and the criteria for establishing the diagnosis are: (1) "preoccupation with one or more delusions or frequent auditory hallucinations" and (2) "none of the following is prominent: disorganized speech, disorganized or catatonic behavior, or flat or inappropriate affect." !d. at 313-14. 38. singleton, 319 f.3d at 1030 (heaney, j., dissenting). although antipsychotic medi­ cations and their considerable side effects have been at the core of other cases like riggins v. nevada, 504 u.s. 127 (1992), and sell v. united states, 539 u.s. 166 (2003), the issues in singleton never turned on the medications themselves. consequently, the record fails to identify the exact medications singleton took. in general, though, current medications used to treat schizophrenia include the so-called ''typical" antipsychotics, which include chlorproma­ zine, thioridazine, and haloperidol. these medications tend to decrease positive symptoms of the illness, like delusions and hallucinations, but they have a limited effect on negative symp­ toms, like apathy and loss of affect. the "atypical" antipsychotics, like risperidone, olanzapine, clozapine, may also be part of a medication regimen. their side effects may be severe. for example, clozapine can cause agranulocytosis (a deficiency of white blood cells), which has a death rate of 1 per 10,000 patients. other blood disorders may occur. the side effect profile also includes sedation, weight gain, blood pressure regulation difficulties, and incontinence. for more information about diagnosing and treating schizophrenia, see generally herbert y. meltzer & s. hossein fatemi, &hizophrenia, in current diagnosis & treatment in psycidatry 260, 260-277 (michael h. ebert et al. eds, 2000). 39. singleton, 319 f .3d at 1030 (heaney, j., dissenting) (recounting events that elucidate the extent of singleton's illness). 40. !d. 2005] involuntarily medicating the psychotic inmate 123 periods, singleton invariably lapsed into a psychosis. according to court records, "whenever he was offhis medication, his symptoms wouldresurfaee, and he would again experience hallucinations . . . . [h]e was observed stripping off his clothes and speaking in a strange language. he became paranoid and delusional, and believed that he had already been executed.'"'1 · over the years, his psychosis became more than disturbing--it became dangerous. by 1995, prison psychiatrists heightened their level of concern and said that singleton was a paranoid schizophrenic with a "high •potential for violence. ""'2 at one point, he told a social worker that he was "on a mission from god to kill him and the president.'"'3 in 1997, his psychiatrists discontinued his medications to assess his status without them. he quickly became "very hostile, belligerent, and probably psychotic.',.... he announced that he was "on a mission from god" and that he needed to kill his treating physician and the president. 45 this threat, coupled with another to kill his psychiatrist, led observers to note that his demeanor displayed "lethal hosti­ lity. '"'6 during a three-week period without medications, he continued to dis­ play psychotic behavior: telling staff that he had been "freed by the eighth circuit and the u.s. supreme court," exhibiting poor hygiene, informing the staff that he was "god and the supreme court" and that his sentence had been vacated.47 he was also observed to be "nude and 'zombie-like"' in his cell, to be "almost nonresponsive," to have tom up and flushed his mattress, and to have flooded his cell.48 as singleton's attorney explained, "when he is off his medication, he eventually loses a lot of weight, stops eating, completely loses all control of his hygiene, and essentially goes into wild gesticulations and ... [talks about] whatever word salad pops into his head."49 a clear pattern emerged-singleton was floridly psychotic without psychiatric medi­ cations. prison psychiatrists then created a plan to medicate singleton, with or without his consent, if he became psychotic, dangerous, and refused to participate in his treatment. 50 41. id at 1031. 42. dateline nbc: crazy like a fox?, supra note 4 (quoting arkansas department of corrections psychiatrists' records). 43. !d. 44. singleton v. norris, 319 f.3d 1018, 1031 (8th cir. 2003). 45. !d. 46. dateline nbc: crazy like a fox?, supra note 4. 47. singleton, 319 f.3d at 1031. 48. !d. 49. american morning: two death row inmates scheduled to die tonight in arkansas (cnn television broadcast, jan. 7, 2004). 50. periodically, psychiatrists on the arkansas penitentiary's medication review panel adjusted singleton's medication regimen to keep his symptoms in check. at times, even while medicated, he displayed psychotic symptoms. at one point, he described himself as the victim of a voodoo curse. at another, he suffered ftom "disturbing hallucinations in which his food turned to worms and cigarettes became bones." singleton, 319 f.3d at 1031. 124 indiana health law .revmw [vol. 2:117 by his own admission, singleton preferred his medicated, non-psychotic state. 51 he explained the role ofhis antipsychotic drugs in a 1999 interview with nbc's dateline: "they get me-they put me back in touch with-i'm able tq listen to you and understand what you're talking about without hearing another story."s2 although the medications reduced his symptoms and calmed his hallucinations, they also created a dilemma. they made him sane enough, as the current law defines, for execution. 53 even his longtime attorney jeffrey rosenzweigs" agreed that under the relevant legal standard, singleton was lucid enough to die when medicated.ss but without antipsychotic drugs, he did not meet the essential criteria and, legally, could not face capital punish­ ment. the coalescence of involuntarily administered antipsychotic medications and competency for execution created a novel and controversial issue that became the basis of singleton's final appeal.s6 the arkansas supreme court stated the question succinctly: may the state ''mandatorily medicate [singleton] with antipsychotic drugs in order to keep him from being a danger to himself and others when a cqllateral effect of that medication is to render him competent to understand the nature and reason for his execution[?]"s7 or, as singleton put it, "am i too sane to live, or too insane to die?"58 the cynical view of that question is that singleton was clever and manipulative. like most people, he would do just about anything to forestall his death. the more charitable view is that singleton found an achilles heel in the execution process and physicians' involvement with it, one that created what some physicians consider to be an intolerable dilemma. 51. ld. at 1025. ("the record before us indicates that singleton prefers to take the medication rather than be in an unmedicated and psychotic state."). 52. dateline nbc: crazy like a fox?, supra note 4. 53. see discussion on washington v. harper, 494 u.s. 210 (1990), infra part i.a. 54. paul greenberg, time is running out and so is sanity in the curious case of charles singleton, ark. democrat-gaze'ite, jan. 4, 2004, at 72 (noting that rosenzweig had represented singleton since 1981). 55. kevin drew, arktmsas prepares to execute mentally m inmate, cnn.com, jan. 5, 2004, at http://www.cnn.com/2004/la w /01/05/singleton.death.row/index.html (last visited apr. 17, 2005) (on file with the indiana health law review). 56. this and related issues involving involuntary medication and prisoners have inspired heated debate. see, e.g., broce a arrigo & jeffiey j. tasca, right to refuse treatment, competency to be executed, and therapeutic jurisprudence: toward a systemic analysis, 23 l. & psychol. rev. 1. 1-47 (1999); fred cohen & joel dvoskin, inmates with mental disorders: a guide to law and practice, 16 mental&physicaldisabn.ityl. rep. 339,33946 (1992); kirk heilbmn et al., the debate on treating individuals incompetent for execution, 149 am. j. psychiatry 596, 596-97 (1992); r. andrew shultz-ross, theoretical diffzculties in the treatment of mentally ill prisoners, 38 j. forensic sci. 426, 428 (1993); broce j. winick, competency to be executed: a therapeutic jurisprudence perspective, 10 beha v. sci. &l. 317,317-37 (1992). 57. singleton v. norris, 964 s.w.2d 366,368 (ark. 1998). 58. dateline nbc: crazy like a fox?, supra note 4. 2005] involuntarily medicating the psychotic inmate 125 b. article overview this article argues that the eighth circuit's holding in singleton ·v. norris was correct and that it is ethical and perhaps even required for physi"' cians to medicate psychotic death row inmates. through an analysis thatuses legal, ethical, and policy arguments, this paper analyzes the salient dilemma and discerns the proper role for the physician who cares for a patient like singleton. this approach aims to illuminate the doctor's dilemma, and it speaks to whether a physician who medicates an inmate like singleton violates an ethical duty to the patient or the profession. part i offers historical and contextual background about the rights that individuals with mental illnesses have. secured in both the civil and criminal settings. part n discusses the eighth circuit's opinion in singleton v. norris and analyzes the arguments against and for forcibly medicating singleton. part ill offers principled solu­ tions for physicians who, despite the article's analysis, believe that it was indefensible to medicate singleton. finally, part iv is an epilogue, offering concluding thoughts on the case. i.. mental illness and the legal system discussions about the rights of the mentally ill and advocacy to guaran­ tee those rights by law are relatively new.59 historically, the insane were relegated to society's periphery-ostracized, feared, ignored.60 after world war n, author and journalist albert deutsch investigated the conditions of state-run institutions for the mentally ill, and his book on this subject begins with a discussion of the sad legacy of mental illness. "insanity was once considered a sin or the consequence of sin," he writes.61 "the insane were punished as sinners or imprisoned as criminals ... sent to priests to be exor­ cised of the devils within them ... hanged or burned as witches, particularly during the terrible witchcraft mania that swept through europe and parts of america in the seventeenth century.'162 witch-hunts abated as religious fervor gave way to enlightenment ideals of free thought, and theories about 59. paul s.appeibaum,ai.most arevolufion: mentalhealthlaw and the limits of change 3-16 (1994). 60. see albert deutsch, the shame of the states (gerald n. grob et al. eds., arno press 1973) (1948); edward shorter, a history of psychiatry: from the era of the asylum to the age of prozac (1997); insanity,institutions and society 1800-1914 (joseph melling & bill forsythe, eds., 1999). for a discussion of the history of mental illness and the rise of psychiatry, see roy porter, madness (2002). 61. deutsch, supra note 60, at 9. deutsch visited "scores and perhaps hundreds" of psychiatric institutions. id. at 19. he photographed and chronicled the wretched conditions at prominent institutions like the philadelphia state hospital for mental disease (byberry) and ohio's cleveland state hospital. 62. id. at9. porternotesthat"over200,000people,ma.inlywomen, were executed during the witch craze" in 16th century europe. porter, supra note 60, at 25. 126 indiana health law review [vol. 2:117 demons were replaced with ones about psychopathology.63 as university of york historian anne digby writes about this era in england, "although there was a range of attitudes towards madness, the dominant conception within this spectrum was beginning to change ... madness was seen less as a spiritual disease, in which the mad, possessed by the devil, were sinful or immoral, and more as a secular condition.'om social scapegoats shifted from witches to "beggars, criminals, and vagrants.'>65 by the early nineteenth century, "[t]he great majority of the insane were then housed in local poorhouses and jails and treated as common paupers and criminals.•>66 still, problems abound as the mentally ill were mistreated and tortured, "chained to walls and floors of filthy cells; beaten and whipped; subjected to solitary confinement for years; manacled, camisoled, and cribbed without provocation; driven into hopeless insanity when they might have been cured by prompt and effective treatment or even by simple humane care.'>67 later, democratic principles inspired a new sense of sympathy among the public for ''their defenseless bretbren."68 in 1841 in the united states, dorothea lynde dix, a lifelong advocate for the mentally ill, began her crusade to move the insane to state hospitals. 69 population growth and the industrial revolution contributed to changes in social conditions, which led to creating public institutions to house the mentally iij.1° although a new sense of social responsibility marked an important step towards humane treatment for individuals with mental illness, state-run institutions quickly filled, became overcrowded, and remained problematic well into the twentieth century. as montagu lomax, a physician who treated patients at various european asylums during the early 1900s, noted, "i have no hesitation in saying that ... our present system of asylum administration is a failure."71 around the time of america's baby boom, deutsch found that "not a single state mental hospital in the whole country [ niet] all the minimum standards of care and treatment established twenty years ago by the american psychiatric association."72 the landscape was bleak, at best. 63. porter. supra note60, at 31-32. 64. annedigby,madness,morauty and medicine 1 (1985). 65. porter. supra note 60, at 32. 66. deutsch, supra note 60, at 33-34. 67. /d. but see porter. supra note 60, at 99-100 (discussing the varying quality of asylums and that some "could also be supportivej. 68. deutsch, supra note 60, at 33-34. 69. !d. at 35. 70. id. at 33-34. 71. montagulomax, llmexperiencesofanasyujmdoctor 14(1921). lomax was remarkably prophetic about the nature of mental illness and its basis in neurochemical pathology. he wrote, ''we cannot explore the brain-cells of a madman during an attack of acute mania or melancholia, and say whether they are or are not materially affected. the probability-nay, the certainty-is that they are[.]" id. at 35. 72. deutsch, supra note 60, at 183. 2005] involuntarily medicating 1he psychotic inmate 127 a. civil rights guarantees by the 1960s, change was afoot in mental health law, as it was in so many areas of society.73 it was time for action. incremental changes in and moderate attention to mental health care were not enough. sadly, "the prin­ ciples on which mental health law was based in 1961 were the same ones that prevailed in 1881."74 while advances in pharmacological treatment were critical in improving care on the medical front, 75 legal changes were valuable as well. in the 1964 hospitalization of the mentally lll act, congress codified the right of the confined mentally ill patient to treatment, not just custodial care.76 the act guaranteed that "[a] person hospitalized in a public hospital for a mental illness shall, during his hospitalization, be entitled to medical and psychiatric care and treatment."77 the extensive hearings held while congress crafted this legislation illustrate heightened attention to the plight of people with mental illnesses.78 today, it is hardly debatable that the hospitalized mentally ill patient has a statutory right to and requires psychiatric treatment. the right to refuse treatment is a necessary corollary of that right to treatment. 79 informed consent, which encompasses the right to choose, accept, or refuse medical treatment, is a core tenet of medical ethics. 80 the idea gained legal grounding in justice louis brandeis's olmstead opinion, which discussed the importance of the right ''to be let alone"81 and in justice benjamin cardozo's opinion for the court of appeals of new york in schloendotjf, which established the principle that "[ e ]very human being of adult years and sound mind has a right to determine what shall be done with his own body ... .''82 more recently, the supreme court has recognized the 73. appelbaum, supra note 59, at 4 (discussing the "thoroughgoing overhaul of law applicable to the mentally ill" that took place from the late 1960s to the mid-1980s). 74. ld. at 3 (citing the mentally disabled and nm law (f.t. lindman & d.m. mcintyre, eds., 1961)). 75. see, e.g., w. wolfgangfleiscbhacker,phannacologicaltreatmentofschizophrenia: a review, in schizophrenia 15, 75-76(mariomaj &normansartoriuseds.,1999)(explaining that antipsychotic treatment introduced in the 1950s was a "breakthrough" for the treatment of schizophrenia). 76. 1964 hospitalization of the mentally ill act, § 21-562, 79 stat. 750, 758 (1965) (codified as amended at d.c. code ann.§ 21-562 (2005)). 77. id. 78. to protect the constitutionallughts of the mentally rl: hearing on s. 935 before the subcomm. on constitutional rights of the s. com. on the judiciary 88th cong. 12 (1963). 79. for more on the contours of the right to refuse treatment see generally bruce j. winick, the right to refuse mental healtii'i'rbatmbnt (1997). 80. see generally, ruthfadenet al.,ahlstory andtheoryofinformedconsent (1986). 81. olmstead v. united states. 277 u.s. 438, 478 (1928) (brandeis, j., dissenting); see union pacific railwayv. botsford, 141 u.s. 250,251 (1891) ('~o right is held more sacred, or is more carefully guarded at common law, than the right of every individual to the possession and control of his own person ... 'to be let alone.'"). 82. schloendortfv. society of the n.y. hosp .• 105 n.e. 92, 93 (n.y. 1914). 128 indiana health law review [vol. 2:117 importance of rights to bodily integrity and personal autonomy, both crucial aspects of the consent doctrine. 83 these rights are not absolute. in a few limited situations, informed consent is not required. 84 because a delay in treatment may jeopardize the patient's life or health, and because the patient may be comatose or delirious, consent is not always required in emergency situations.85 physicians may also withhold decision-making information when, in their estimation, such infor­ mation would cause severe distress for the patient. 86 patients may also waive their right to consent. furthermore, patient consent is not required when that individual lacks decision-making capacity; instead, a surrogate's decision is sought.87 clinical standards for decision-making capacity are not identical to legal standards for competence. from a clinical perspective, ethicists explain that physicians should be sure their patient appreciates the nature of their medical situation (understanding the prognosis, the recommended care, alternatives and their risks and benefits). 88 the decision should be stable over time, consistent with the patient's goals and values, and uninfluenced by delusions or hallucinations. 89 from a legal perspective, courts do not always adhere to a uniform standard for determining competence, and one commentator has found that the courts deal with the issue "only in a cursory way.'>90 in the more confined mental health care setting, the parameters of an individual's right to refuse care and the standards for determining his capacity to do so· are less opaque. in his exhaustive treatise on the right to refuse mental health care, university of miami school of law professor bruce j. winick explains that an individual becomes incompetent to make decisions when his "judgment is so affected by his mental illness that he lacks the capacity to make a well-reasoned, willful, and knowing decision concerning treatment.''91 also, patients deemed incompetent to make medical decisions 83. see vacco v. quill, 521 us 793, 798 (1997) ("everyone, regardless of physical condition, is entitled, if competent, to refuse unwanted lifesaving medical treatment[.]"); cruzan v. director, missouri dept. ofhealtb, 497 us 261, 278 (1990) ("the principle that a competent person has a constitutionally protected liberty interest [under the dtle process clause] in refus­ ing unwanted medical treatment may be inferred from our prior decisions." (citations omitted)). 84. bernard lo, resolving enncaldilemmas: a guide for clinicians 31 (1995) (hereinafter ethical dn.emmas]; see also pauls. appelbaum, et al., informed consent: legal theory and clinical pracfice (1987). 85. ethical dilemmas, supra note 84, at 32. 86. /d. 87. /d. 88. /d. at 85. 89. /d. at 32. 90. id at 84 (citing alan meisel, theriohttodie (1995)). 91. w1nick. supra note 79, at 120 (quoting fla. stat. ch. 394.459(3xa) (1995)). 2005] involuntarily medicating the psychotic inmate 129 may not necessarily be universally incompetent.92 a patient may, for example, exhibit uncharacteristic clarity about his finances. decision-making capacity aside, the right to refuse care is limited in psychiatric settings. many mentally ill patients meet clinical standards for in­ competence and thus fall within an exception to informed consent. further­ more, it is widely agreed that patients should not "rot with their rights on. "93 that is, they should not be allowed to make unsound decisions about their care in the name of informed consent and personal rights. while hospitals must obtain consent when possible, either from the patient or his surrogate, they may not meet that ideal at all times. one author offered a dismal indictment of this system: "state hospital patients, whether voluntary or involuntary, are rarely provided an explanation of the presumed benefits and potential risks of drug treatment, are seldom asked for their consent and are often forcibly injected if they resist oral medication."94 of course, that sentiment reflects the research and analysis of one individual, and state hospital practices may have improved over the past decade. although consent from the incompetent patient may not be required for treatment, legal protections apply in common psychiatric situations. state laws protect citizens who face involuntary civil commitment, providing, for example, a right to a prompt hearing on the matter.95 mentally ill inpatients may also be required to take psychotropic medications if they are dangerous or are incompetent. ideally, a surrogate decision-maker or a court-appointed guardian has been consulted about treatment decisions. liberty interests give way, but again, the government and the medical system aim to protect those interests as much as possible. 96 importantly, involuntary medication orders in the civil setting do not universally require a showing of immediate, tangible dangerousness. in new york, after a schizophrenic man who was noncompliant with his antipsychotic medications pushed a woman into an oncoming manhattan subway car and killed her, the state legislature passed a law ''joining nearly 40 other states in adopting a system of assisted outpatient treatment (aot) pursuant to which psychiatric patients unlikely to survive safely in the community without super92. see paul s. appelbaum & thomas g. ouihen,. clinical handbook of psychiatry and the law 220 (williams & wilkins 2d ed. 1994) ("the mere presence of psychosis, dementia, mental retardation, or some other form of mental illness or disability is insufficient in itself to constitute incompetence."). 93. paul s. appelbaum & thomas g. gutheil, "rotting with their rights on": constitutional theory and clinical reality in drug refusal by psychiatric patients, 7 buu.. am. acad. psychiatry & l. 306 (1979). 94. winick, supra note 79, at 77. 95. see, e.g., cal. weiji. & inst. code§ 5250 (deering 2005). 96. see, e.g., addington v. texas, 441 u.s. 418, 433 (1979) (holding that 14th amendment due process protections require "clear, unequivocal and convincing evidence" in a civil commitment proceeding before involuntarily placing an individual in a mental hospital for an indefinite period oftime). 130 indiana health law review [vol. 2:117 vision may avoid hospitalization by complying with court-ordered mental health treatment.'>97 in february 2004, the court of appeals of new york upheld the constitutionality of that law.98 another recent state supreme court case emphasizes that an explicit showing of immediate dangerousness is not required to obtain a court order for treatment. in steele v. hamilton county community mental health board,99 the ohio supreme court held that a paranoid schizophrenic could be involuntarily medicated even though he was not dangerous to himself or others. noting that he was incapable of giving informed consent and outlining the procedural due process required to issue the order for forced medications, the court found that the mentally ill, involuntarily committed patient could be medicated even if dangerousness was not a concern if the court found clear and convincing evidence that (1) the patient lacked capacity to give consent, (2) the medication was in his best interest, and (3) no less intrusive treatment would be as effective. the steele court found authority to override the signi­ ficant liberty interest at stake in the state'sparens patriae power-the state's obligation to care for its citizens, especially those who, because of mental illness, are unable to care for themselves-as long as specified due process protections are met. 100 this distinction is important: whereas the mentally ill criminal may be medicated involuntarily when he meets criteria that include dangerousness, the mentally ill citizen may be medicated without his consent ifhe is seriously disabled, even ifhe is not dangerous. here, as in other situa­ tions, safeguards remain in place. for example, a court-appointed guardian may be asked to review the patient's record to determine if medication is in the patient's best interest. overall, then, patients with mental illness enjoy legal recognition of important treatment rights. although they, like all patients, have a basic right to medical and psychiatric care and a right to refuse those interventions, incompetence may suspend some rights to refuse medical assistance. civil 97. in the matter ofk.l., 806 n.e.2d 480,482 (n.y. 2004). 98. /d. at 483-86 (holding that new york mental hygiene law § 9.60, so-called "kendra's law," does not violate due process or other constitutional rights and is a reasonable exercise of the state's police power). 99. steele v. hamilton county cmty. mental health bd., 736 n.e.2d 10 (ohio 2000). i 00. id at 21. the court explained, we have attempted to craft a decision that acknowledges a person's right to refuse antipsychotic medication, and yet recognizes that mental illness sometimes robs a person of the capacity to make informed treatment decisions. only when a court finds that a person is incompetent to make informed treatment decisions do we permit the state to act in a paternalistic manner, making treatment decisions in the best interest of the patient. /d. both the parens patriae power and the police power have been cited in cases allowing the state to involuntarily medicate civilians. see addington, 441 u.s. at 426 (holding that a state's parens patriae power allows it to care for citizens who are unable to take care of themselves and that the state "has authority under its police power to protect the community from the dangerous tendencies of some who are mentally ill.''). 2005] involuntarily medicating tile psychotic inmate 131 commitment becomes an option, as does involuntarily administered anti­ psychotic medications. the state's parens patriae and police powers override individual liberty and support treatment that others, ideally a surrogate and a psychiatrist, feel to be in the patient's best interests. because both law and ethics recognize the importance of the rights to bodily integrity and autonomy that are necessarily invaded with involuntary psychiatric treatment, states have important due process regulations in place to protect the degree of invasion and guarantee advocacy for the mentally ill patient a guiding principle emerges-civil society values the importance of medical and psychiatric treat­ ment for incompetent, mentally ill individuals. b. criminal rights guarantees criminals remain a vulnerable population, and criminals with mental ill­ nesses are especially at risk. notably, inmates have a constitutionally guaran­ teed right to health care, 101 which includes psychiatric and psychological treatment.102 district of columbia circuit judge david bazelon' s seminal opinion in rouse v. cameron103 was a legal watershed that helped guarantee 101. estelle v. gamble, 429 u.s. 97, 104 (1976) (establishing that prisoners have a basic constitutional right to medical treatment and defining the standard for constitutional violations as "deliberate indifference to serious medical needs"); see also farmer v. brennan, 511 u.s. 825, 839, 847 (1994) (holding that prison officials may be held liable under the eighth amendment for denying humane conditions of confinement only if the official had actual knowledge that inmates faced a substantial risk of serious harm and he disregards that risk by failing to take reasonable measures to abate it that is, the officials must have '"consciously disregard[ ed]' a substantial risk of serious harm" to the prisoners.). /d. 102. see bowring v. godwin, 551 f.2d 44,47-48 (4th cir. 1977). we therefore hold that bowring (or any other prison inmate) is entitled to psychological or psychiatric treatment if a physician or other health care provider, exercising ordinary skill and care at the time of observation, concludes with reasonable medical certainty (1) that the prisoner's symptoms evidence a serious disease or injury; (2) that such disease or injury is curable or may be substantially alleviated; and (3) that the. potential for harm to the prisoner by reason of delay or the denial of care would be substantial. the right to treatment is, of course, limited to that which may be provided upon a reasonable cost and time basis and the essential test is one of medical necessity and not simply that which may be considered merely desirable. 103. rouse v. cameron, 373 f.2d 451 (d.c. cir. 1966). charles c. rouse was involun­ tarily committed to a psychiatric facility after he was found not guilty by reason of insanity of carrying a dangerous weapon, which was a misdemeanor. he filed a habeas corpus petition and lost at the district court level because the court found that its jurisdiction was limited to the question of insanity, not whether the petitioner was receiving psychiatric treatment, as he had argued. on appeal, judge bazelon noted that the ''principal issues raised by this appeal are whether a person involuntarily committed to a mental hospital on being acquitted of an offense by reason of insanity has a right to treatment that is cognizable in habeas corpus, and if so, how violation of this right may be established." /d. at452. that court found that institutionalization without treatment was little different from inciu'cej'ation, and that the period of confinement was significant-it could extend indefinitely. the court also noted that because congress authorized 132 indiana healrn law review [vol. 2:117 rights to such care via statutory interpretation. the rouse court extended the "right to treatment" idea that congress established in its 1964 hospitalization of the mentally ll1 act104 to those who were involuntarily institutionalized per court order in a criminal proceeding. 105 these hard won gains are crucial in the criminal setting because so many individuals entangled with the justice system are mentally ill and inmates cannot seek care on their own. 106 indeed, psychiatric illness and incarceration are familiar bedfellows. 107 it is difficult to know which came first, the illness or the crime, but it is clear (in perhaps a gross understatement) that "[t]he institution itself is not condu­ cive to good mental health. " 108 in 1999, the justice department estimated that sixteen percent of state and federal prisoners suffered from schizophrenia, bipolar disorder and/or major depression.109 in 2000, the american psychia­ tric association estimated that twenty percent of prisoners had a serious mental illness, with up to five percent of those individuals experiencing active psychosis at any particular time."0 a 2004 human rights watch report the 1964 hospitalization of the mentally ill act, which entitled mentally ill individuals hospitalized in public facilities to medical and psychiatric treatment, it could avoid constitu­ tional questions about the right to treatment in all, the court held that a right to treatment existed, and that institutions were required to make a "bona fide effort" to improve and cure the patient. id. at 456. 104. d.c. code ann.§ 21-562 (2005). 105. for general discussion on the inception of this right to treatment, see 1he right to treatment: a symposium (donalds. burris ed., 1969). 106. although prisoners have a right to care, securing a particular right does not necessarily make ita reality. for a detailed analysis of the disturbing nature of incarceration and psychiatric illness, see terry a. kupers, prison madness: 1he mental health crisis behind bars and what we must do about it (1999). kupers, a psychiatric expert who has testified in various class action lawsuits contesting the conditions of confinement and the quality of psychiatric and medical care available in prisons, describes the prison conditions that lead the sane to become insane and the insane to become considerably worse, noting that mental health treatment is "grossly deficient" and that prison conditions are "increasingly harsh." id. at xvi. 107. for an epidemiologic approach to quantifying mental illness in the prison system, see nathanielj.pailone,mentali>jsorderamongprisoners:towardanepidemiologic inventory (1991). 108. curtis prout & robert n. ross, care and punishment: 'ilie dilemmas of prison medicine 216 (1988). ("prison life is enough to drive anyone crazy. the boredom, deprivation, isolation, and alienation make even the simplest forms of gratification difficult. for these reasons all but the most passive inmates are deeply angry.") id. at 208. 109. paula m. ditton, u.s. dep't of justice, ncj 174463, mental health treat­ ment of inmates and probationers (july 1999) (discussing the scope of mental illness in prisons and finding that sixteen percent of state prison inmates, seven percent of federal inmates, and sixteen percent of those in local jails reported either a mental condition or an overnight stay in a mental hospital. the study also provides detailed statistics about mental illness, breaking down the data about crime and incarceration by race, gender and age). 110. fox butterfield, study finds hundreds of thousands of inmates mentally ill, n.y. times, oct. 22, 2003, at a14; see also h. richard lamb & linda e. weinberger, persons with severe mental illness in jails and prisons: a review, 49 psychiatric services 483, 483 (1998) ("clinical studies suggest that six to 15 percent of persons in city and county jails and 10 to 15 percent of persons in state prisons have severe mental illness."). 2005] involuntarh..y medicating the psychotic inmate 133 estimated that "as many as one in five of the 2.1 million americans in jail and prison are seriously mentally ill, far outnumbering the number of mentally ill who are in mental hospitals.'' ill jails and prisons have turned into de facto mental health hospitals, something that no one involved with mental health or the prison system ever wanted. just as the right to refuse medical care follows the right to receive medical care in the civil setting, these rights travel together in the criminal arena as well. interestingly, "a dramatic transformation has occurred in the law pertaining to mental patients and prisoners. in the past 20 years, the battleground has shifted to litigation on behalf of these groups asserting various provisions of the constitution as restrictions on unwanted imposition of treatment:•m clearly, from a constitutional perspective, inmates have a significant due process interest in avoiding unwanted antipsychotic medica­ tion, but that right is not absolute. 113 for example, california recognizes that inmates have "a fundamental right.against enforced interference with their thought processes, states of mind, and patterns of mentation .... " 114 in order to balance that right with the need for psychiatric care, california requires a court order to compel medication, and to receive that order, the health care team must show that the proposed therapy would be beneficial, a compelling state interest supports its administration, no less onerous alternative therapies are available, and the therapy follows accepted medical-psychiatric practice. 115 the constitutional limits on a prisoner's right to refuse antipsychotic medications have been increasingly defined. in washington v. harper, 116 the supreme court held that a state could ''treat a prison inmate who has a serious mental illness with antipsychotic drugs against his will, if the inmate is dangerous to himself or others and the treatment is in the inmate's medical interest. " 117 the harper court found that the need for safety and orderin the prison system, coupled with the state's obligation to provide appropriate medical care for its prisoners, justified invading a prisoner's "significant liberty interest in avoiding the unwanted administration of antipsychotic drugs ••• .''118 notably, the court emphasized deference to the medical profes­ sionals who determine treatment plans because they "possess, as courts do not, the requisite knowledge and expertise to determine whether the drugs should 111. butterfield, supra note 110, at a14 (reporting on human rights watch, ill­ equipped: u.s. prisons and offenders withmentaliilnesses (2003)). 112. winick, supra note 79, at 130. 113. see kansas v. hendricks, 521 u.s. 346, 356 (1997); united states v. salerno, 481 u.s. 739, 750-51 (1987); youngberg v. romeo, 457 u.s. 307, 320 (1982). 114. cal. penal code§§ 2670-2680 (deering 2005). 115. cal. penal code §2679(b) (deering 2005). 116. washington v. harper, 494 u.s. 210 (1990). 117. /d. at 227. 118. /d. at 221; see also riggins v. nevada, 504 u.s. 127, 135(1992) (holding that the state may forcibly administer antipsychotic medication to a prisoner or criminal defendant despite his liberty interest in some circumstances if the medication is medically appropriate, as detennined by a physician). 134 indiana health law review [vol. 2:117 be used in an individual case. "119 the harper inquiry, asking for a finding of both dangerousness and medical appropriateness, has become a standard for the involuntary medication of mentally ill inmates. harper had the concomi­ tant effect of altering physicians' behavior-that is, physicians could follow the standard of care only if the inmate met the test for dangerousness, not if he were simply mentally ill or gravely disabled and incompetent to make healthcare decisions, as in the civil setting. the criminal situation, in that sense, created a higher standard for invading individual liberty interests. however, the supreme court altered the contours of the right to refuse psychotropic medications in a related situation-the trial setting-in sell v. united states. 120 in sell, the court asked whether the constitution allows the governmentto medicate a psychotic defendant involuntarily with psychotropic medications to render him competent to stand trial for nonviolent but serious white collar crimes. the defendant, dr. charles thomas sell, a dentist with a long history of psychosis who was arrested for fraud, initially presented a danger to himself and others during his pretrial detention. medication was felt to be appropriate by his hospital physicians, but he refused to take such drugs. he remained incompetent to stand trial, even after a rather lengthy detention. since the state intended to medicate him so he could stand trial, the case presented a new question about the appropriateness and constitutionality of involuntary medication. after revisiting the weighty liberty interests at stake in the forced medication context, the court held that the constitution allowed the govern­ ment to medicate an individual, in rare circumstances, for the overlapping purposes of treating illness and creating competence to stand trial. the court explained that the exact purpose of the medication was inapposite: a court need not consider whether to allow forced medica­ tion for that kind of purpose [rendering the defendant compe­ tent to stand trial], if forced medication is warranted for a different purpose, such as the purposes set out in harper related to the individual's dangerousness, or purposes related to the individual's own interests where refusal to take drugs puts his health gravely at risk. there are often strong reasons for a court to determine whether forced administration of drugs can be justified on these alternative grounds before turning to the trial competence question. 121 119. harper,494 u.s. at230. 120. sell v. united states, 539 u.s. 166 (2003). for a critique of the sell decision, see megan quinlan, note, forcible medication and personal autonomy: the case of charles thomas sell, 84 b.u. l. rev. 275 (2004). 121. sell, 539 u.s. at 181-82 (citation omitted). 2005] involuntarily medicating the psychotic inmate 135 the court found that ''the constitution permits the government involuntarily to administer antipsychotic drugs to a mentally ill defendant facing serious criminal charges in order to render that defendant competent to stand trial,''122 but the court set strict guidelines that balance government needs. specifi­ cally, medication is allowable "only if the treatment is medically appropriate, is substantially unlikely to have side effects that may undermine the fairness of the trial, and, taking account of less intrusive alternatives, is necessary significantly to further important governmental trial-related interests."123 however, the court held that involuntary medication was not appropriate in the sell circumstance because the lower courts did not consider the trial­ related side effects and risks of the drugs, as well as the lengthy nature of sell's current confinement. hypothetically, though, it is possible to involun­ tarily medicate a non-dangerous defendant with antipsychotic drugs in order to render that individual competent to stand trial, if, along with the other sell factors, such treatment is medically appropriate.124 today, no court has extended sell beyond the competency-for-trial setting. still, the dangerous­ ness requirement regarding forced medication in the criminal context may have been eviscerated, at least when creating competence to stand trial. until sell, the standard for involuntary medication in criminal settings remained distinct from the civil standard, but this case represents a departure from that rule. dangerousness aside, teaching of sell is that an inquiry into the state's or defense's motivation regarding medication is unimportant when the defendant's situation falls under harper or when the defendant "puts his 122. /d. at 179. 123. /d. 124. united states v. gomes, 305 f. supp. 2d 158 (d. conn. 2004) (granting the govern­ ment's request for involuntary antipsychotic treatment of a defendant with a grandiose and persecutory type of delusional disorder to stand trial on the felony charge of possessing a firearm with a felony record). interestingly, the court found that since the sell criteria were met. a defendant who was neither dangerous nor gravely disabled could be medicated in order for him to stand trial. the court did note, as part of its sell analysis, that medication was medically appropriate to treat his delusional disorder, so the decision to medicate essentially turned upon what psychiatrists determined to be appropriate care.). other courts have considered similar situations but have not found the sell criteria to be met. the gravity of the criminal charge seems to be a definitive factor for courts. see. e.g., united states v. dumeny, 295 f. supp. 2d 131, 131-32 (d. me. 2004) (denying the government's request to involuntarily medicate the defendant to restore his competency for trial and finding that the state interest in adjudicating the charge of "possession of firearms by a person previously committed to a mental health institute" was insufficient to overcome the defendant's liberty interests); united states v. miller, 292 f. supp. 2d 163 (d. me. 2003)( denying medication-for-trial request and finding no impor­ tant government interest at stake, an inadequate showing of medical appropriateness, and an inadequate consideration of the side effects of antipsychotic medications); united states v. evans, 293 f. supp. 2d 668 (w.d. va. 2003) (finding that although treatment was medically appropriate, the importance of rendering a defendant competent to stand trial on a charge of forcibly intimidating and interfering with a government employee while she discussed the status of his overdue housing loan did not outweigh this non-dangerous, non-gravely disabled individual's right to be free from antipsychotic medications). 136 indiana healm law review [vol. 2:117 health gravely at risk."125 the question of the state's motivation becomes irrelevant. c. special considerations for death row assuming that mental illness has not preceded incarceration, it is difficult to stay free of symptoms of mental illness in prison, and the uniquely arduous conditions on death row make clinging to clarity extremely challeng­ ing. estimates about the number of insane inmates awaiting execution vary. researchers calculate that roughly forty to seventy percent of death row inmates are psychotic. 126 a 2003 report from the british broadcasting com­ pany on mentally ill death row inmates in america asserts that approximately ''ten percent of the 3,500 prisoners on death row are regarded as insane."127 given the psychological pressure of waiting for one's execution day to arrive coupled with the miserable conditions in many prisons,128 it is somewhat astonishing that the fraction of psychotic inmates does not approach one hundred percent.129 stanley williams, a san quentin death row inmate who has written about life and psychosis at that institution, remarked, "prison is a place where grown men have gone insane. it is a place where men have been 125. sell, 539 u.s. at 182. 126. see robert johnson, deatiiwork: astudyoftiiemodernexecutionprocess 50 (1990) (estimating that seventy percent of death row inmates suffer from mental illnesses); dorothyotnow lewis eta!., neuropsychiatric, psychoeducational, and family characteristics of 14 juveniles condemned to death in the united states, 145 am. j. psychiatry 584 (1988) (fifty percent of juveniles on death row whom the author surveyed suffered from some form of psychosis); dorothy otnow lewis et al., psychiatric, neurological, and psychoeducational characteristics of 15 death row inmates in the united states, 143 am. j. psychiatry 838 ( 1986) (forty percent of surveyed adult death row inmates suffered from chronic psychosis). 127. abc online, foreign correspondent: u.s.a.-death row medication, at http://www.abc.net.aulforeignlstories/s894253.htm (last visited apr. 17, 2005) (on file with the indiana health law review) (providing a synopsis of bbc: u.s.a.-death row medication (bbc television broadcast aug.7, 2003)). 128. see judge orders state to clean death row, chi. trm., may 22, 2003, at 20 (reporting that u.s. magistrate jerry a. davis, in an opinion about death row conditions, berated the government: ''no one in a civilized society should be forced to live under conditions that force exposure to another person's bodily wastes." davis ruled that harsh conditions were contributing to a high rate of mental illness among prisoners and ordered mississippi prisons to reform.). 129. the number of death row prisoners suffering from severe mental illnesses may, in fact, be quite high. see david freedman & david hemenway, precursors of lethal violence: a death row sample, 50 soc. sci. & med. 1757 (2000). the authors surveyed sixteen death row inmates in california and found some degree of impairment in every case, including fourteen with posttraumatic stress disorder, thirteen with severe depression, and twelve with traumatic brain injury. 2005] invowntarily medicating tile psychotic inmate 137 killed and where some have even killed themselves. prison is hell. this i know."130 insanity, as the singleton saga makes clear, can become an obstacle to execution. historically, the common law barred killing the insane.131 the celebrated commentator blackstone argued that such killings were "savage and inhumane" and that they eliminated the possibility that the convicted criminal could assist in advocating for a stay of his own execution.132 sir edward coke advanced humanitarian reasoning as well as concerns about losing the deterrent value of the execution if the state put the insane to death. to coke, the executed prisoner should serve as an example, "but so it is not · when a mad man is executed, but should be a miserable spectacle, both against law, and of extream [sic].inhumanity and cruelty, and can be no example to others."133 other reasons for exempting the insane from execution include the lack of retributive value-if the prisoner fails to connect his crime with his punishment, the punishment becomes meaningless-along with the spiritual need to be aware of one's impending death in order to properly prepare for it. although the prohibition against executing the insane dates back hundreds of years, a constitutional limit on executing prisoners with mental illnesses is relatively new. in 1897, the supreme court held in nobles v. georgia134 that hearings were an unnecessary part of due process protections for a mentally incompetent prisoner. other courts and legislatures responded to that holding with a nod toward the insane by not executing such individuals, finding that there was no legal reason to do so.135 the court revisited ques­ tions of competency and execution in ford v. wainwright, 136 holding that the eighth amendment's bar against cruel and unusual punishment precluded the state from executing an inmate who carried a diagnosis of paranoid schizo­ phrenia and did not understand that he was to die because of his crime. the 130. greg lefevre, inmate nominated/or nobel prize, cnn.com, dec. 7, 2000 (quoting stanley wiwams, life in prison {2001)), at http://www.cnn.com/2000/us/12/02/death. row.nobel/index.html (last visited apr. 17, 2005) (on file with the indiana health law review). for another account of the troubling conditions on death row, see johnson, supra note 126. 131. see, e.g., auson weir, henryvill: 1hb king and his court (2001 ). biographer weir notes that at one point during his reign, king henry vm "had demanded that parliament pass an act making it lawful for him to execute an insane person who had committed treason" in order to execute the extremely distressed lady rochford. id. at 450. the existence of such a request illustrates the apparent illegality of executing the insane. 132. 4 wiwam blackstone, commentaries *24-*25 ("(a)nd if, after judgment, he becomes ofnonsane memory, execution shall be stayed: for peradventure, says the humanity of the english law, had the prisoner been of sound memory, he might have alleged something in stay of judgment or execution."). 133. fordv. wainwright,477u.s. 399,407 (1986)(quotinge.coke, 3 institutes6(6th ed. 1680)). 134. nobles v. georgia, 168 u.s. 399, 409 (1897). 135. bruce a. arrigo & christopher r. williams, law, ideology, and critical inquiry: the case oftreatment refusal for incompetent prisoners awaiting execution, 25 new eng. j. on crim. & civ. confinement 367,367-68 (1999). 136. ford v. wainwright, 477 u.s. 399 (1986). 138 indiana heal til law revibw [vol. 2:117 court reasoned that executing the insane would depart from legal tradition, offend humanity, and fail to meet the state's retributive and deterrence goals. it was unmoved by a singular rationale for this ban, but rather, it noted, "whether its aim be to protect the condemned from fear and pain without comfort of understanding, or to protect the dignity of society itself from the barbarity of exacting mindless vengeance, the restriction finds enforcement in the eighthamendment."137 because no state sanctioned executing the insane, the holding was largely uncontroversial. while the ford majority did not explicitly define how to determine competence for execution, lower courts have looked to justice lewis powell's concurrence in ford for the articulation of a standard. powell culled the standard from existing state statutes that, on the whole, focused on under­ standing the nature and purpose ofthe punishment.138 as justice thurgood marshall noted, "[i]t is no less abhorrent today than it has been for centuries to exact in penance the life of one whose mental illness prevents him from comprehending the reasons for the penalty or its implications."139 powell noted that some states "have more rigorous standards, but none disputes the need to require that those who are executed know the fact of their impending execution and the reason for it."140 he wrote that the constitution forbids the execution "only of those who are unaware of the punishment they are about to suffer and why they are to suffer it."141 powell's test-whether a con­ demned person understands the nature of and reason for his punishment-is the legacy of ford and the standard generally used to determine competence for execution.142 137. ford, 477 u.s. at 410. 138. see, e.g., ga code .ann. § 17-10-60 {2004)( convict must understand the punishment and why it is to be imposed on him). 139. ford, 477 u.s. at417. 140. ford, 477 u.s. at 422 {powell, j., concurring)( footnote omitted). but see ford, 477 u.s. at 435 (rehnquist, j., dissenting) ("i find it unnecessary to 'constitutionalize' the already uniform view that the insane should not be· executed, and inappropriate to 'selectively incorporate' the common-law practice."). 141. ford, 471 u.s. at422 {powell, j., concurring). 142. it has been criticized as a low threshold, one that the court should clarify. see rector v. bryant, 501 u.s. 1239 (marshall, i., dissenting from denial of certioriari). justice marshall explained, in ford v. wainwright, 477 u.s. 399 (1986), this court recognized that ''the eighth amendment prohibits a state from carrying out a sentence of death upon a prisoner who is insane." id at 409-410. the full court, however, did not attempt a comprehensive definition of insanity or incompetence in this setting. this petition presents the question whether a prisoner whose mental incapacity renders him unable to recognize or communicate filets that would make his sentence unlawful or unjust is nonetheless competent to be executed. because ford leaves this question unanswered, and because this is an important and recurring issue in the administration of the death penalty, i would grant the petition. id at 1239 2005] involuntarjlymedicatingthepsychoticinmate 139 before charles singleton's most recent appeal, only louisiana had adjudicated a case where forced antipsychotic medications and the death penalty clashed. in state v. perry, 143 an insane inmate on louisiana's death row challenged whether the state could forcibly medicate him with anti­ psychotics for the sole and explicit purpose of restoring his competence for execution. importantly, the issue of medication arose in the execution context, and the state failed to prove that medication furthered '"both the best medical interest of the prisoner and the state's own interest in prison safety."144 rather, the state aimed to make perry lucid enough to die. the louisiana supreme court held that the state's "medicate-to­ execute" scheme failed to advance a compelling state interest, violated perry's rights to bodily integrity and to refuse medical care, and fell short of the harper requirements. 145 the perry court found that involuntary medication, in this context, violated the cruel and unusual punishment clause of louisiana's state constitution.146 the court stayed the death sentence until perry could become competent without antipsychotic medication. louisiana's rule about antipsychotic medications in the context of executions seems to be that an execution cannot go forth until the prisoner has regained his sanity and is no longer taking antipsychotic medications. 147 143. state v. perry, 610 so. 2d 746 (la. 1992). 144. according to the perry court, "[t]he state in perry's case has made neither showing but seeks forcible medication of a prisoner by court order as an instrument of his execution." id at 751. however, there is some confusion in the case on this issue. justice marcus, in his dissenting opinion, noted that "the trial court found perry to be a danger to others, and the sanity commission was of the opinion that psychotropic medication relieved the symptoms of perry's disorder with minimal side effects and was in his best medical interest" id. at 777 {marcus, j, dissenting). if the majority had agreed with that opinion, perry and singleton would address similar issues. 145. id. at 755. 146. see also singleton v. state, 437 s.e.2d 53, 62 (s.c. 1993) (holding that ·~ustice can never be served by forcing medication on an incompetent inmate for the sole purpose of getting him well enough to execute."). 14 7. the court found perry to suffer from an "incurable schizoaffective disorder," a disease that, according to the court, will never be cured or quelled. perry, 610 so. 2d at 748. further, the court found that involuntary medication in this context undermines the patient's trust in his physician, places the state's goals above patient well-being, which, the court said, creates an incongruous position for physicians, and gives rise to implementing the death penalty in an arbitrary and capricious way. essentially, louisiana would suspend death sentences for anyone with a severe mental illness that requires antipsychotic medications for treatment id. the court also argued that the "aggregate of conditions surrounding the physician's determination of the prisoner's mental capacity at the time of execution does not yield room for well-informed and dispassionate medical judgment." !d. at 753. states obviously differ in their conclusions on this issue. see, e.g., in re emergency amendment to florida rules of criminal procedure (rule 3.811, competency to be executed), 497 so. 2d 643, 644 (fla. 1986) a prisoner who, because of psychotropic medication, has sufficient ability to understand the nature and effect of the death penalty and why it is to be imposed upon him or her shall not be deemed incompetent to be executed simply because his or her satisfactory mental condition is dependent upon such medication. 140 indiana health law review [vol. 2:117 ll. singleton's situation and the psycihatrist's dilemma from the preceding discussion, it is clear that as a matter of constitu­ tionallaw, a psychotic inmate's liberty interest in bodily integrity yields to neuroleptic medication if that inmate both poses a danger to himself or others and medicating him would be in his medical interest.148 it is also clear that individuals must be competent to face execution.149 it is less clear what happens when these rules collide. a. singleton v. norris-where harper meets ford the facts of singleton illustrate its uniqueness in constitutional law. it was the first federal case to link involuntary antipsychotic medications with competence for execution. singleton, a death row inmate who became psy­ chotic during his incarceration, met the harper requirements for involuntary medication and would have been medicated but for his death sentence. because the antipsychotic medications effectively rendered him ford compe­ tent for execution,150 the problem became a syllogism. singleton needed id 148. washington v. harper, 494 u.s. 210 (1990). 149. ford v. wainwright, 477 u.s. 399 (1986). 150. but see singleton v. norris, 319 f .3d l 018, 1034 (heaney, j., dissenting) (recounting psychiatrist dr. mrad's opinion that singleton may not be competent even when medicated.) a psychiatrist who examined singleton said that he might be psychotic even while medicated. according to judge heaney, singleton admitted to having continued hallucinations, and "occasionally referred to himself as god or god-like and on a few occasions referred to himself as the holy spirit." (mrad dep. at 21.) regarding singleton's understanding of his punishment, mrad stated: "i asked him if he was god, how could be be executed, and he slapped his arm and said i've got this. my understanding referring to a body. he could be-he could be executed and that it would-and i think he knew that the reason for the execution would be conviction for the murder ofmary lou york and by that i believed he had a factual understanding. he could recite-basically recite basic facts that he would ~what the sentence was and why he would be given that sentence. the other part of it, the rational understanding i think was-has more to do with does he actually understand what this means, not only can he say it but does he actually understand what this means and what it means as applied to him, and it was not at all clear to me that he did. his thinking was so disorganized. he made these frequent comments about being the holy ghost or holy spirit. he talked about a-some beliefs about a parallel world, about being-an execution just being stopping breathing and then you start up again somewhere else and that-there was some statement made about correctional officers. execution correctional officers stop you from breathing and then the judge can do something to start it up again. id at 1032. he also mentioned that singleton was writing a book per god's request, that he and a particular saint were on a mission against homosexuals, and that "sylvester stallone and arnold 2005] involuntarily medicating die psychotic inmate 141 medications to treat his psychosis. when medicated, he was competent to be executed. yet, death was a fate he wished to avoid for a long period of time since his conviction. therefore, could the state involuntarily medicate singleton, since he was a danger to himself and others, knowing that those medications would have the likely effect of rendering him ford competent for execution?151 in singleton v. norris, 152 a closely divided en bane panel of the eighth circuit court of appeals answered that question in the affinnative. the core issue, the eighth circuit said, was whether neuroleptics were medically appropriate. it explained that: [i]n the circumstances presented in this case, the best medical interests of the prisoner must be determined without regard · to whether there is a pending date of execution. thus we hold that the mandatory medication regime, valid under the pendency of a stay of execution, does not become unconstitu­ tional under harper when an execution date is set.153 in a six-to-five decision, the majority held that the state does not violate the constitution if it executes a prisoner involuntarily medicated under harper, and it may forcibly administer antipsychotic& to a death row inmate who is scheduled for execution. some observers called it a victory for states' rights.154 others saw it as aloss for prisoners' autonomy.m despite its impli­ cations, the united states supreme court declined to hear the case on appeal. 156 because it crystallizes an ongoing controversy in law and medical ethics, singleton presents an important question for physicians and society. schwarzeneggerwere somewhere between this universe and another one and were trying to save him." /d. 151. although singleton presented a novel legal issue, some prescient commentators anticipated it. see arrigo & williams, supra note 135, at 379. arrigo and williams noted: id interestingly [fordj does not guarantee that mentally ill prisoners awaiting execution and asserting a right to refuse treatment would. in all instances, be protected from capital punishment, despite eighth and fourteen amendment safeguards. indeed, consistent with the holding in harper, to the extent that an inmate presented a dangerous risk to other prisoners, to correctional stati: and to himself, forced drug therapy could be constitutionally ordered. this result could follow, notwithstanding an inmate's h"berty interest in refusing involuntary psychiatric treatment and in avoiding mental punishment. this weighty matter has yet to be addressed by the u.s. supreme court. 152. singleton v. norris, 319 f .3d 1018 (8th cir. 2003), cert. denied, 540 u.s. 832 (2003). 153. /d. at 1026. 154. adam liptak, state can make/nmatesaneenough to execute, n.y. times, feb. 11, 2003, ata1. 155. /d. 156. singleton v. norris, 540 u.s. 832 (2003). 142 indiana health law review [vol. 2:117 b. is it legal and ethical to treat singleton? unfortunately, even with the legal advances of the last forty years, adequate mental health care in prison remains elusive. one recent report said it is "almost non-existent:•is7 although singleton turns on the rightto refuse mental health care, this issue and the consequent dilemmas it creates should not overshadow the very real and pressing problems that many inmates face, like substandard mental health care and higher rates of mental illness among female inmates.158 it is a system overwhelmed by need. this article's focus on the right to refuse guaranteed mental health care is somewhat ironic in the context of scarce services. it is but a sliver of the larger picture, and it should not cloud the overwhelming need for psychiatric services facing so many incarcerated individuals. with that disclaimer, the analysis of singleton follows. i. arguments against treatment judge heaney's dissenting opinion in singleton offered an excellent summary of the strongest arguments against involuntary treatment.159 first, he posed an "artificial competence" theory. that is, a medicated inmate will never meet the ford standard for competence because treatment only masks psychotic symptoms. the inmate is never actually cured. as ronald tabak, a new york-based attorney who has represented clients in death penalty cases, says, "ifhe [singleton] is artificially made to be competent, then the situation is an oxymoron."160 according to this argument, antipsychotic medications simply hide the psychosis. the patient is never cured, and his incompetency merely remains ''muted" for the duration of his treatment. under this view, antipsychotics interfere with the individual's ability to think and express himself, potentially implicating first and sixth amendment concerns, and the competency that follows their administration is false. because treatment is not curative, the inmate is never truly competent. 157. butterfield, supra note 110, at a14 (reporting that a justice department investigation found that a wyoming state penitentiary had a psychiatrist on duty only two days a month, and in iowa, three psychiatrists were responsible for more than 8,000 inmates). for a discussion on the complexities of providing medications and medical care to a prison population, see curtis prout&robertn.ross,careandpunishment:thedii.bmmasofprisonmedicine 16268 (1988). 158. ditton, supra note 109, at 3 (finding mental illness among twenty-four percent of female state prison and local jail inmates). 159. of the three dissenting opinions, two disagreed with the majority on procedural grounds; only judge heaney addressed the constitutional claims at length. singleton, 319 f.3d at 1029 (loken, j., concurring in part and dissenting in part); singleton, 319 f.3d at 1030 (heaney, j., dissenting in which bright, j., mcmillian, j., and bye, j.,join). 160. drew, supra note 55. 2005] involuntarily medicating the psychotic inmate 143 second, judge heaney argued that the state's interest in exacting punishment undermined its interest in treatment. this view posits that harper is a convenient excuse to medicate singleton-the government's only real goal is to,carry out the punishment that it had been waiting to mete out for the betterpm;toftwo decades. third, the judge remained unconvinced that forced medical treatment was in singleton's medical interest when it may ultimately facilitate his execution. proponents of this view explain that death is neverin a patient.~s "medical interests," and therefore, forcing singleton to take medi­ cations that will likely render him ford competent fails to meet the second prong of harper. as georgetown university law professor and psychiatrist dr. m. gregg bloche put it, treating singleton represents "a parody of physi­ cians' failure to treat the whole patient. the notion that you can view treat­ ment as medically appropriate when the immediate legal consequence of treat­ ment success is death is out of' alice in wonderland. "'161 it is, he says; the equivalent of saying that the operation was successful even though the patient died.l62 finally, judge heaney rebuked the majority for creating a terrible dilemma for the medical profession-to treat, understanding that execution may resul~ or not treat, knowing that psychosis awaits the inmate. judge heaney concluded that the state's interest in protecting the integrity of the medical profession and alleviating its ethical dilemma argues for a permanent stay of execution. this argument claims that physicians are placed in an impossible bind that betrays their principles of medical ethics. medicating singleton, so the argument goes, conflicts with the medical profession's tenet to do no harm. the physician acts as the executioner's handmaiden. essen­ tially, his actions are the ''but for" cause of the execution, and he kills the patient. as psychiatrist and author paul s. appelbaum explains, "[ o ]rdinarily when a person is suffering from psychosis, our impulse is to treat that person, to try to diminish their symptoms and diminish their suffering."163 in the singleton case, he continued, ''we're in a situation where the very treatment that we render, rather than helping our patients, has the probability ofleading to greater harm, in fact, the ultimate harm of allowing them to be put to death."164 since the physician is now seen as an arm of the government's killing machine, arguments against physician participation in executions may 161. all things considered: legal dispute over whether a state can force a man who is psychotic to take medication to make him legally sane in order to execute him {npr broadcast, feb. 12, 2003). 162. id. 163. nightline: executing the mentally ill (abc television broadcast, may 19, 1998). 164. ld. 144 indiana health law review [vol. 2:117 be invoked. 165 careful analysis reveals that these arguments fail. not only is it legal to medicate singleton, it is also ethically required. 2: arguments for treatment .) a. singleton follows well-established constitutional law· it is hardly debatable that singleton adheres to the clear constitutional law on medicating insane inmates. in terms of the harper inquiry; the record is unequivocal. singleton was dangerous to himself and others in the prison setting when left off his medications. singleton never actually debated this point. as the arkansas supreme court found in singleton's 1998 appeal,"[ a] harper decision was made by a three-person medication review panel on august 18, 1997, that the state did have a legitimate reason to medicate singleton without his consent, and that decision was not appealed by him to circuit court."166 advocates for singleton's position argue that harper's second prong, the medical interests inquiry, fails in hindsight because medica­ tions lead to ford competency-and execution cannot be in his medical interests. because it presents a somewhat circular analysis, the question of medical appropriateness will be addressed in detail below. it is also indisputable that singleton met the ford standard for compe­ tence. a panel of experts, singleton's attorney, and the eighth circuit agree on this point. opponents of this conclusion can only point to the artificial competence argument-an argument that simply proves too much. many individuals live with chronic diseases like hypertension, epilepsy, depression, bipolar disorder, hn, diabetes and asthma. their medications, just like psychotropic medications, do not cure their illness. they only control its symptoms. moreover, society does not consider epileptics who rely on medi­ cation to keep seizures at bay "artificially competent" to work or drive. as the american psychiatric association has argued, "the mental health produced by antipsychotic medication is no different from, no more inauthentic or alien to the patient than, the physical health produced by other medications, such as penicillin for pneumonia."167 medicated citizens do not fall into a separate class with restricted legal privileges and consequences because they rely on pharmaceuticals to create physiologic normalcy. even with emerging psychia­ tric symptoms, it is possible to meet the ford standard. notably, ford does not require a cure or even the disappearance of all psychiatric symptoms. it 165. see, e.g., alfred m. freedman & abraham l. halpern, the erosion of ethics and morality in medicine: physician participation in legal executions in the united states, 41 n.y.l. sch. l. rev. 169 (1996); robert d. truog & troyen a. brennan, sounding board: participation of physicians in capital punishment, 329 new eng. j. med. 1346 (1993). 166. singleton v. norris, 964 s.w.2d 366, 368 (ark. 1998). 167. rigginsv.nevada,504u.s.127, 141 (1992){k.ennedy,j.,concurring)(quotingbrief for american psychiatric association as amicus curiae at 9). 2005] involuntarily medicating the psychotic inmate 145 simply requires that the inmate understand the punishment and why he is to be punished. advocates for singleton also assert that the government's interest in medicating him was impure since it was motivated, at least in part, by the hope of executing him. the eighth circuit explicitly declined to examine the state's reasons for wanting to medicate singleton and instead looked to the motivations of his treating physicians. if it had, it might have found, as the federal: district court did, that .. singleton was not placed on medication to make him competent, so the state could execute him; rather, the court found he was being medicated to meet his medical needs."168 regardless, the supreme court's decision in sell, issued just months after the singleton decision, directly addressed the question of government motivation in involun­ tary medication cases. if the court finds a legitimate reason to medicate a defendant, it is not required to inquire into the state's intent. even assuming the worst, that arkansas purposely aimed to medicate singleton to facilitate his execution, that inquiry becomes irrelevant under sell given the legitimate reasons to medicate him. although sell considered medication in the context of a trial, the holding may apply in other situations. in any event, even if the motivation inquiry were relevant in this case, it is clear that singleton is not perry. singleton does not implicate an explicit, unequivocal medicate-to-execute scheme. as the eighth circuit explicitly noted, there was .. no evidence in this record that the actions and decisions of the medical personnel involved were in any degree motivated by the desire, purpose or intent to make mr. singleton competent so that he could be executed."169 while the government made absolutely no harper showing in perry, the record notes that singleton was medicated with antipsychotic drugs, on and off, for many years. he was dangerous and had been mentally ill long before questions about execution competency became pressing. therefore, accusations that singleton is about using the physician's tools to facilitate an execution are precisely wrong.170 168. singleton, 964 s.w.2d at 370 (glaze, j., dissenting). 169. singleton v. norris, 319 f.3d 1018, 1022 (8th cir. 2003). 170. although the eighth circuit was clear as to the question presented and the consequent holding, the national and international press mischaracterized the key issue. the new york times page one headline said, "state can make inmate sane enough to execute;• and the opening sentence of that article read, ''the federal appeals court in st. louis ruled yesterday that officials in arkansas can force a prisoner on death row to take antipsychotic medication to make him sane enough to execute." liptak, supra note 154, at a1 (emphasis added). for other examples, see dateline nbc: crazy like a fox?, supra note 4. (asking, "but can the state force him to take medication to restore his sanity in order to kill him?''); all things considered, supra note 161 (reporting that "[t]his week, a federal appeals court ruled that the state of arkansas can forcibly medicate a death row inmate to make him sane enough to execute."); a new insanity defence, economist, mar. 1, 2003, at 31 (asking in its subtitle, "can you treat an insane man just so that you can convict or execute him?''); crazy week. ark. democrat-gazetie, jan. 11,2004, at 76 (reportingthattheeighthcircuitcourtofappealshad "decided that [singleton] might be treated in order to be killed"); paul greenberg, time is running out and so is sanity 146 indiana health law review [vol. 2:117 b. treatment is in singleton's "medical interests" before a court may order involuntary therapy, harper's second prong requires that medication support an inmate's "medical interes~," and the singleton case ultimately turned on the definition of that phrase. the singleton court found that ''the best medical interests of the prisoner must be determined without regard to whether there is a pending date of execution."171 that court stood on firm legal ground. case law shows that courts have defined the phrase "medical interests" with an eye toward medical issues, not psychosocial or personal ones. how the inmate feels about medication, whether he would prefer not to continue with the judicial process, what his physician thinks about the judicial process -these questions are inapposite. harper carefully limited its inquiry to medical therapy qua medicine. it did not include other interests the inmate may have had. the court restricted its focus to the side effects of the various in the curious case of charles singleton, ark. democrat-gazette, jan. 4, 2004, at 72 (imploring the governor to halt the execution and reporting that ''the eighth circuit court of appeals agreed that the state of arkansas was within its rights to forcibly medicate said defendant in order to render him sane enough to executed.''). the tone of the reporting conveyed the message that the state's (and its physicians') sole aim was execution, not treatment. this sentiment led to misunderstandings about the case. in the new york times, letters to the editor confused the issues and were generally off point. dr. deborah young said, "we have fallen through the looking glass if it is now considered 'beneficial' to medicate a psychotic prisoner just long enough to declare him or her sane and then proceed to execution, presumably before the medication wears off." deborah young, sanity and execution: a tale worthy of kafka, n.y. times, feb. 14, 2003, at a30. singleton met the standard for involuntary medication, and he would have been medicated even if the drugs failed to restore his competence but only served to make him less dangerous. even the chairman of the american medical association's council on ethical and judicial affairs seemed to misread the case, or else relied solely on the times somewhat misleading report about it. noting the american medical association's code ofmedical ethics decree, that "physicians should not treat the prisoner for the purpose of restoring competence unless a commutation order is issued before treatment," he declared that "no doctor should participate in this process." leonard j. morse, sanity and execution: a tale worthy of kafka, n.y. times, feb. 14,2003, at a30. yet, singleton is not perry, and thus the critique is off base. and from the arkansas democrat-gazette, a letter to the editor was wrong on two counts, asking, "how can our legal system justify medicating back to sanity a person who was mentally ill at the time of a crime just for the purpose of execution?" letters, ark. democrat-gazette, jan. 12, 2004, at 11. singleton was not mentally ill in a legally meaningful way when he murdered york, and competency for execution was a side-effect of the medication, not its raison d' etre. the media outlets mentioned here never clarified the issue. readers deserve accuracy in reporting, especially when the contentiousness of the case turns on an exact reading. amidst the sea of journalists mauling the issues, cnn's brian cabell reported the case correctly: "in february 2003, the 8th u.s. circuit court of appeals ruled that states may forcibly administer anti-psychotic medication to control a prisoner's behavior, even if doing so renders the prisoner eligible for execution.'' brian cabell, arkansas executes mentally ill inmate, cnn .com, jan. 7, 2004, athttp://www.cnn.com/2004/la w/01/06/arkansas.executions/ (last visited apr. 17, 2005) (on file with the indiana health law review). 171. singleton, 319 f .3d at 1026. 2005] involuntarily medicating the psychotic inmate 147 drugs, the standard for treatment of the illness outside of the penal setting, and less intrusive alternatives to quell the inmate's dangerousness. it was uninterested in the tenns ofhis incarceration or what sanity would mean to the prisoner.· ··in sell, the court revisited the "medical interests" question· and offered·further guidance as to the correct definition. it explained that when determining ·the appropriateness of involuntary psychotropic medication orders, "the court must conclude that administration of the drugs is medically appropriate, i.e., in the patient's best medical interest in light of his medical condition. the specific kinds of drugs at issue may matter here as else­ where."172 to date, no court has considered a possible legal ramification of competence, like execution, to be a meaningful aspect of the definition. the majority rule confines the inquiry strictly to clinical issues-looking to physi­ cians' determinations about appropriate treatment, which include balancing the risks of side effects with the benefits of a particular medication.173 it appears, then, that the definition rests on issues that are precisely medical. 172. sed v. united states, 539 u.s. 166, 181 (2003). 173. see united states v. williams. 356 f.3d 1045, 1056 (9th cir. 2004) (looking to "a medically-informed record" for decisions about involuntary antipsychotic medication in prison and during supervised release and noting that the evaluation of medical interests includes ''timely evaluation of the supervise[ e] by a medical professional, including attention to the type of drugs proposed, their dosage, and the expected duration of a person's exposure, as well as an opportunity for the supervisee to challenge the evaluation and offer his or her own medical evidence in response."); dancy v. gee, 51 fed. appx. 906, 908 (4th cir. 2002) (affirming the district court's summary judgment for the government and finding that no violation ora federal inmate's civil or constitutional rights occurred during forced administration of antipsychotic medications because, in terms of the ''medical interests" inquiry, "no medical evidence contradicting the judgments of the medical professionals" was presented. hence, no triable issue of fact existed. here, a paranoid schizophrenic inmate exhibited wildly inappropriate behavior, like throwing urine and feces at others, and was subsequently medicated involuntarily with psychotropic drugs. the treating psychiatrist determined such medications were "clinically appropriate" and "medically necessary'' in light of the clinical situation.); united states v. weston, 206 f.3d 9, 12 (d.c. cir. 2000) (focusing the inquiry around "medical appropriate­ ness" on treating psychiatrists' clinical recommendations); jurasek v. utah state hosp., 158 f.3d 506, 513 (loth cir. 1998) (following harper to determine the constitutional floor for forced mental treatment in a civil context and looking to "medical best interests"); fearance v. scott, 56 f.3d 633,642 (5th cir. 1995) (denyingstayofexecution andhabeasrelieffor a death row inmate taking psychotropic medications for "therapeutic purposes"); united states v. brandon, 158 f.3d 947 (6th cir. 1998) (following strictly medical considerations for the "medical interests" inquiry); ashby v. schneck, no. 94-3354, 1995 u.s. app. lexis 17154 (8th cir. july 17, 1995) (adhering to a psychiatrist's findings about medical interests. which were strictly limited to medical issues); see also united states v. gomes, 305 f. supp. 2d 158, 168 (d. conn. 2004) (looking to medical issues to answer the medical interests query-noting that the evaluating psychiatrists "considered the benefits and potential side effects and concluded that, on balance, treatment with medications was the indicated course of treatment''). but see washington v. harper, 494 u.s. 210, 245 n.11 (1990) (stevens, j., dissenting) (''the qualitative judgment of what is a patient>s best interest cannot be made without reference to his own preferences"). even so, there is no indication from the fuller court that the expanded inquiry must consider the inmate's or civilly committed individual's interest in avoiding legally sanctioned judicial proceedings or punishments. 148 indiana health law review [vol. 2:117 essentially, courts confine their inquiry to what is medically indicated, deferring to doctors' assessment of clinically appropriate treatment, which, in turn, is guided by the standard of care. for acute agitation, the psychiatric course includes antipsychotic and antianxiety medications, like lorazepamand haloperidol, to achieve behavioral control with minimal side effects}:i4 high potencyneuroleptics are also useful, and atypical or typical antipsychotics are important in long-term treatment to prevent relapse. 115 thus, whatis in the patient's ''medical interests" is to follow the standard of care. 176 the standard of care does not change in the criminal setting (and should not change, given the constitutional requirement to provide medical care), and further, failing to follow the standard of care in any other setting would be medical malprac­ tice.177 if physicians would forcibly medicate the individual in question were he in a mental hospital, or if it would be negligent not to treat a patient with an identical presentation in a non-penal setting, it follows that treatment is in the prisoner's "medical interest" clearly, were he not slated for death, singleton would be medicated. and even more tellingly, if the medications helped but did not quite render singleton competent to face execution, he would be medicated. therefore, distilling objections to the holding in singleton down to their essence make it clear that the issue is only about the death penalty itself.178 c. medicating singleton-a question of ethics courts, as explained above, do not consider the totality of the inmate's circumstances when issuing an order for forcible psychotropic medication. i 74. alison fife & jennifer scbreiber,psychiatricemergencies: agitation or aggression, uptodate, at http://patients.uptodate.com/topic.asp?file=psychiat/5564&title=psychiatric+ emergency#2 (last changed july 27, 2004). 175. fleischhacker, supra note 75, at 84-91. 176. united states v. weston, 134 f. supp. 2d 115, 119 (d.c. 2001). psychiatrists howard zonana and· deborah deprato offered expert testimony on the standard of care to inform the court about appropriate treatment for a defendant who was incompetent to stand trial. the court explained that "the overwhelming evidence that antipsychotic medication is the cornerstone of treating weston's illness." ld. at 125. 177. i d. ("dr. zonana stated that the standard treatment for schizophrenia is antipsychotic medication, and not to treat weston with such medication would be medically negligent more­ over, drs. zonana and deprato testified that they were unaware of any hospital in the country that would not treat weston with antipsychotic medication." (internal citations omitted)). 178. judge heaney, a vehement dissenter in singleton, has a long history of adamant opposition to the death penalty. see singleton v. norris, 108 f .3d 872, 874-75 (8th cir. 1997) (concurring, heaney, j.). ld (a]lthough i am bound to uphold the law, i write separately to add my voice to those who oppose the death penalty as violative of the united states constitution. my thirty years' experience on this court have [sic] compelled me to conclude that the imposition of the death penalty is arbitrary and capricious. 2005] involuntarll.. y medicating the psychotic inmate 149 critics argue that whether or not courts weigh the inmate's entire situation, physicians must consider execution as part of their decision-making process. medical ethics demand it. as singleton's attorney, jeffrey rosenzweig, said when he framed the question in singleton's final appeal to the supreme court, "to what extent ... can a government take invasive, involuntary action using medical personnel who are sworn to heal, save and treat when the result of their medical application and experience is not healing, treating and saving but instead has the result of causing execution?"179 this question is curious. medical ethics do not preclude treatment and may in fact require it. (i) legal repercussions should not influence treatment decisions physicians are ethically bound to treat a patient's illness-not what awaits him when he recovers. in sports, team physicians should weigh the player's medical situation when determining treatment options, not what will happen to the team's playoff chances if he misses the big game. similarly, doctors should not develop treatment plans with an eye toward shielding patients from the law or influencing legal outcomes, like scheduling an elective surgery to avoid a tax court appearance, downplaying a worrisome psychiatric history so the patient can have custody ofher children, or creating a diagnosis to meet worker's compensation payment standards. at best, this is an approach unfocused on medical issues; at worst, it is dishonest. medical treatment would become a system of idiosyncratic sympathies for the most persuasive patients. that system would not comport with the ethical precept of justice, which requires that physicians offer similar treatment to patients in similar medical situations, without regard to race, class, gender or even crime, and it would smack oflying, a clear ethical violation. critics of this position argue that treatment decisions must incorporate the context of patients' lives and that physicians always include patients' goals in the calculus of care. of course, it is appropriate and ethical to include patient preferences in recommendations for care. decisions about a course of chemotherapy, for example, must consider the patient's values, balancing a chance for a longer life against the onerous side effects of treatment. although medical decisions cannot be made in a vacuum, considering a patient's lifestyle and personal choices in the context of treatment and illness is vastly different from aiming to evade the justice system and using the physicians' unique powers to do so. execution should not change the goals of care or the obligation to the patient more than any other impending legal consequence.180 179. liptak, supra note 154, at ai. 180. fmthennore, it is clearly inappropriate for physicians to express their displeasure with a social or political reality by using patients as a conduit for their opinions. if a physician abhors the fact that a beloved patient will be incarcerated for a white collar crime, he cannot 150 indiana health law review (vol. 2:ll7 (ii) medical ethics precludes singleton from wallowing in psychosis ·beneficence, another precept of medical ethics, requires that pliysicians act in the best interests of their patients. singleton argued that becaus~execu­ tion was not in his best interests overall~ medication that may tender him competent for execution could not be in his medical interests. it followed, he said, that because physicians who treated him would violate medical ethics, the eighth circuit should stay his execution. assuming that death is not in his best interests, involuntary antipsychotic treatment does not betray benefi­ cence. it is a balancing act. without treatment, singleton suffered horribly, and he actually preferred his medicated state, regardless of any side effects that may have existed. in fact, not treating singleton would violate the ethical principle ofnonmaleficence-do no harm. 181 shirking his medical care, care that he would receive in any other criminal or civil setting, is harmful. when a patient experiences extreme suffering, the unethical course may be to leave him hopelessly sick and dangerously psychotic. 182 again, it is critical to recall that no actor in the singleton situation explicitly aimed to kill him. notably, the singleton court found no evidence that the physicians caring for singleton ''were in any degree motivated by the desire, purpose or intent to make mr. singleton competent so that he could be executed."183 the case does not mirror perry's medicate-to-execute scheme. even if, as the 1982 united nations principles state, "it is a contravention of medical ethics for health personnel, particularly physicians, to be involved in any professional relationships with prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental simply admit that patient to a hospital to help her duck a sentence. physicians are also restricted from discrimination-a pro-life/anti-choice cardiologist should not tum away a patient because she had an abortion years ago. ethics requires that physicians be, quite simply, physicians. 181. a dissenting judge in perry agrees with this analysis and actually would have medicated perry, absent a harper showing. the supporting sentiment: if, in fact, a physician is sworn to do no harm and to act only in the best medical interests of his patients, i fail to see how administering an antipsychotic drug manufactured to alleviate suffering in those for whom it is indicated, i.e., those manifesting overt psychotic symptoms, can reasonably be construed as doing harm or acting against the patient's best medical interests. state v. perry, 610 so.2d 746, 778 (cole, j., dissenting). 182. some critics argue that physicians must preserve life at all costs and that medicating an inmate who may be executed violates that requirement assuming that that assessment is correct, physicians do not myopically preserve life in the usual course of their practice. for example, in many cases, withholding or withdrawing life support may be the most ethical course. see, e.g., t.e. corbett, withholding life-prolonging medical treatment, 256 jama 1263 (1986). 183. singleton v. norris,319 f.3d 1018, 1022 (8th cir. 2003). 2005] involuntarily medicating the psychotic inmate 151 health[,]"184 singleton's physicians aimed to treat his psychosis and danger­ ousness. were singleton simply docile and demented, or if his symptoms were contained but he remained incompetent for execution, or if the standard of care did'not support treatment, then a medication regimen devised solely to facilitate. his death would, in fact, violate the ethical principles of benefi­ cence anclnonmaleficence. the distinction turns on intent. intent· is crucial in both law and ethics. criminal law distinguishes identical acts through the actor's intent, and mens rea is integral to proving a crime. 185 · as the supreme court explained in vacco v. quill, intent creates a distinction with a meaningful difference, one with strong legal and ethical roots: · the law has long used actors' intent or purpose to distinguish between two acts that may have the same result. see, e.g., united states v. bailey, 444 u.s. 394,403-406 (1980) ("the ... common law ofhomicide often distinguishes ... between a person who knows that another person will be killed as the result of his conduct and a person who acts with the specific purpose of taking another's life"); morissette v. united states, 342 u.s. 246, 250 (1952) (distinctions based on intent are "universal and persistent in mature systems oflaw"); m. hale, 1 pleas of the crown 412 (1847) ("ff a., with an intent to prevent gangrene beginning in his hand doth without any advice cut off his hand, by which he dies, he is not thereby felo de se for tho it was a voluntary act, yet it was not with an intent to kill himself'). put differently, the law distinguishes actions taken "because of' a given end from actions taken "in spite of' their unintended but foreseen consequences. pers. adm 'r of massachusetts. v. feeney, 442 u.s. 256, 279 (1979); compassion in dying v. washington, 19 f.3d 790, 858 (9th cir. 1996) (kleinfeld, j., dissenting) ("when general eisenhower ordered american soldiers onto the beaches of normandy, he knew that he was sending many american soldiers to certain death .... his purpose, though, was to ... liberate europe from the nazis"). 186 184. principles of medical ethics, g.a res. 37/194, u.n. gaor, i 11th mtg., u.n. doc. airex/37 /194 (1982). importantly, no court bas been swayed by u.n. principles, and at least one court bas specifically rejected them. see. united states v. weston, 134 f. supp. 2d 115, 126 (d.c. 2001) (citing principles of medical ethics, supra). 185. johnkaplan,et al.,crim1nallaw: cases and materials 181-286 (2000). 186. vaccov. quill, 521 u.s. 793,802-803 (1997). 152 indiana health law review [vol. 2:117 in medical ethics, the intent distinction has developed its own doctrine of "double effect."187 behavior that might be unethical when animated by a particular underlying intent may become acceptable when the physician's aim differs. for example, a physician does not kill a patient when that patient refuses life-sustaining medical treatment. as court explained in vacco, "the distinction comports with fundamental legal principles of causation and intent. first, when a patient refuses life-sustaining medical treatment, he dies from an underlying fatal disease or pathology; but if a patient ingests lethal medication prescribed by a physician, he is killed by that medication."188 the legal system already relies on physicians to differentiate their intent when treating inmates. government physicians must separate treatment from punishment and a duty to the state from a duty to the patient. courts may use physicians as a check on the penal system by assuming that they can focus on the disease itself. the harper court deferred to physicians to detennine the limits of appropriate individual treatment, stating that it ''will not assume that physicians will prescribe these drugs for reasons unrelated to the medical needs of the patients; indeed, the ethics of the medical profession are to the contrary."189 the law expects physicians to act with appropriate intent. the double effect doctrine further posits that physicians may employ a treatment intended to help the patient even if potential harm is foreseeable but unintended. in the palliative care setting, aggressive pain management may hasten death. medical consensus supports such a course as long as pain relief remains the primary goal. as justice stephen breyer explained in his vacco concurrence, "[t]he laws ofnew york and of washington do not prohibit doctors from providing patients with drugs sufficient to control pain despite the risk that those drugs themselves will kill" because the intent is to control pain, even if a foreseeable risk of that treatment is death.190 even those who find the idea unpalatable must acknowledge that it has found a place in ethics and law, and that it is a core teaching of critical care.191 in fact, due to its 187. the birth of double effect has been attributed to thomas aquinas and his predecessors. see tom l. beauchamp & james f. chnl>ress, principles of biomedical ethics 160 (4th ed. 1994). it was originally employed for use in a religious context, allowing catholics to have abortions when the intent was to save the mother's life, not to kill the fetus, and medical ethics has adopted it for its own purposes. 188. vacco, 521 u.s. at 801 (citing people v. kevorkian, 527 n.w. 2d 714, 728 (1994), cert. denied, 514 u.s. 1083 (1995)); matter of conroy, 486 a. 2d 1209, 1226 (1985) (when feeding tube is removed, death "results ... from [the patient's] underlying medical condition"); in re colyer, 660 p. 2d 738, 743 (1983) ("death which occurs after the removal of life sustaining systems is from natural causes"); american medical association, council on ethical and judicial affairs, physician-assisted suicide, 10 issues in law & medicine 91, 92 (1994) ("when a life-sustaining treatment is declined, the patient dies primarily because of an underlying disease.")). 189. washington v. harper, 494 u.s. 210,223 n.8 (1990). 190. vacco, 521 u.s. at 810 (breyer, j., concurring). 191. john m. luce & ann alpers, end-of-life care: what do the american courts say?, 29 critical care men. n40 (2001). 2005] involuntarn.. y medicating the psychotic inmate 153 greater attenuation from the cause of death, double effect may be less objectionable under the facts in singleton than in the classic circumstance of the morphine drip used to treat end-of-life pain. 192 with the aggressive use of opiates, the action that may kill the patient and the action of the physician are the same. in the case of the dangerously psychotic inmate, the physician's action (treating psychosis) and the action that kills the patient (execution) are distinct by time, actor, and intetvention.193 given that reality, it is unclear why the medical community should restrict the principle of double effect and it say that it is inapplicable to treating psychotic death row inmates. if hastening death is an unintended but foreseeable consequence of aggressive pain management at the end of life, then rendering singleton competent for execution can be characterized as an unintended but foreseeable consequence of neuroleptics that treat dangerous psychotic symptoms. 194 it is not an execution preparation regime. as the new york state task force on life and the law has explained, "[m]edical treatment sometimes requires significant trade-offs, and ... acceptance of negative consequences for legitimate medical purposes is not equivalent to causing those consequences for their own sake."195 while the task force was 192. some may argue that double effect has no relevance to singleton's situation. there is no coherent reason why the principle must be limited to one specific situation in medical ethics like physician-assisted suicide, especially when it is more difficult to distinguish intent in the end-of-life context. the principle did not originate in medical ethics, and the field cannot simply borrow it at will, picking and choosing when it is useful. otherwise, the field faces its own double bind-that a core principle can only apply when physicians do not object to the outcome. apparently, directly hastening death at the end-of-life through aggressive pain control is less objectionable than involuntarily medicating an inmate who may become competent for execution. if the double effect is not applicable in this case, the field should reconsider its analysis of intent in physician-assisted suicide as distinct from end-of-life care. it is true that the dying patient does not object to the physician's action and the opiates that may quicken his exit, while singleton objects, at least when he is relatively lucid, to forced medication. but in no other setting do we allow patients to deteriorate into psychosis, object to medication, and leave them in that state. therefore, as i explain infra, the real objection here is to execution itself. 193. again, the causal link is tenuous even though the outcome is foreseeable. for example, assume a law student turns in a final paper late. she fails the class and cannot graduate on time. is the professor to blame? no. the professor did not cause the student to miss graduation even though it was quite foreseeable that if he gave her a failing grade, due to the delinquency of her paper, she would not be wearing a cap and gown that spring. 194. in a letter to the editor of the new york times, a boston lawyer criticized this position, calling it "the worst kind of legal thought." to him, arguing that "(e]ligibility for execution is the only unwanted consequence of the medication," as the singleton majority did, "los[es] sight ofhumanity [and] devalues the entire system of law." jonathan j. margolis, sanity and execution: a tale worthyofkajka,n.y. times, feb. 14, 2003,ata30. but intent­ based reasoning is applicable, and clemency is well within the rights of the governor, who is also an important actor in the legal system. 195. n.y.statetaskforceonlifbandthelaw,n.y.statedep'tofhealth, when deatii is soughi': assisted suicide and euthanasia in the medical context: supplement to report (1997). 154 indiana health law review [vol. 2:117 commenting on pain relief for the dying patient, this sentiment applies with equal force in the death penalty setting. just as the physician in the end of life context intends to ease pain rather than kill the patient (even though the medications may and often do hasten death), the physician intends to alleviate singleton's dangerous psychotic symptoms and relieve the pain of that illness-not to kill him. the former situation is not physician-assisted suicide, and the latter is not physician-sanctioned execution.196 the distinction rests onintettl · the ethical physician will treat singleton because medication relieves his psychosis and because that course follows the prevailing standard of care. it does· not follow that this kind of treatment is equivalent to facilitating execution. but even if it did, staunch opponents of physician involvement in the execution process agree that beneficence is not lost when a dangerous or gravely ill psychotic inmate is treated, even if therapeutic success means certain death. as the american college of physicians has said, "a delusional prisoner's self-mutilating behavior or a severely disorganized psychotic inttlate' s inability to eat invite the judgment that the urgency of relieving agony or forestalling an immediate threat to life outweighs the prospect of execution."197 the american medical association's code of medical ethics concurs: "if the incompetent prisoner is undergoing extreme suffering as a result of psychosis or any other illness, medical intervention intended to mitigate the level of suffering is ethically permissible. " 198 in singleton, the purpose of involuntary medication is to treat a mentally ill man. and when a prisoner, a patient, is so profoundly ill with behaviors and thoughts that make him dangerous and disabled, antipsychotics are required.199 196. thedoubleeffectprinciplemayringhollowforphysicianswhoactuallyorderforcible medication of an inmate with antipsychotics that do, in filet, render that individual competent for execution. to them, it may feel like an impossible bind. like physicians who actively withdraw care from their patients, those involved with forcibly medicating a prisoner awaiting execution may feel that they are killing the patient but according to intent-based logic, they are not 197. am. coil. of physicians et al., breach of trust: physician participation in executionsintheunitedstates41-42(1994)(notingthat"thisexceptionshouldbesharply limited, to cases of extreme suffering or immediate danger to life.'') (emphasis omitted). 198. couns.onethical&jud.aff.,am.medicalass'n,codeofmedicalethics,e2.06 (2002). 199. but see am. coil. ofphysicianset al.,supra note 197, at 42. treatment that restores death row inmates to competence for execution is widely believed to be unethical. however, some prison psychiatrists content that it is ethical so long as it is done for the purpose of relieving the psychiatric symptoms, rather than for the purpose of kiuing the inmate .•. [this] distort[s] the hippocratic commitment into an ethic of indifference to patients as persons. this indifference is underlined by the obviousness of the penal function that such treatment serves. however the treating psychiatrist understands his or her role, ·· the ultimate, public end furthered by clinical "success" is the execution of the condemned. psychiatric treatment that has the effect of restoring competence should thus, as a rule, be regarded as unethical. 2005] involuntarily medicating the psychotic inmate 155 faced with this conclusion, some critics may argue that even if justice, beneficence and nonmaleficence are served, autonomy, the fourth pillar: of medical ethics, undermines the argument to treat.200 i~ does not. impommt liberty interests are implicated in the right to refuse antipsychotic medica~ions, but those rights are not limitless. even if a surrogate decision-maker 9r the individual when competent refuses the medications, the court may still impose treatment. the supreme court in harper specifically considered whether the incompetent prisoner was entitled to have a guardian's substituted judgment regarding the decision. as the weston court recalled, .. [i]n harper, for instance, the inmate reportedly said he 'would rather die than take medication,' but the court approved the treatment as in the inmate's medical interest."201 the harper court found that the state's interests needed tobe part of the analysis, and that the right to avoid unwanted drugs .. must be defined in the context of the inmate's confmement."202 the court also rejected arguments about consent .. out ofhand."203 psychiatry has little quarrel here. 204 in general, psychiatrists and courts are uninfluenced by incompetent patients' refusals, even if they refuse medications during a coherent period for future instances of psychosis and incompetence.205 further, because forcible treatment will not necessarily create competency, we create a clumsy rule when autonomy becomes the over­ riding concern. what if singleton became less psychotic and less dangerous on medications, but he was still found to be incompetent for execution? would forced medication be acceptable? if so, then involuntarily adminis­ tered psychotropics are only problematic when execution follows. a rule that neuroleptics are forbidden only when they lead to competence is overly broad. it could inhibit treatment, abandon a subset of patients, and lead to an unsafe environment for prisoners and personnel. if forced medication is only ld. (emphasis omitted). this position carves out an exception to the intent-based analysis, used throughout medical ethics and criminal law, presumably because its authors are death penalty opponents. as i explain in part lll, there are more appropriate ways to challenge capital punishment than to mold ethical arguments to suit one's political purposes. 200. see beauchamp & cididress, supra note 187 (discussing these core principles of medical ethics). 201. united states v. weston, 255 f.3d 873, 878 n.4 (d.c. cir. 2001) (internal citation omitted). 202. washington v. harper, 494 u.s. 210, 222 (1990). 203. id. at 226. 204. united states v. weston, 134 f. supp. 2d 115, 127 (d.c. 2001) (holding that the government may administer antipsychotic drugs to a pretrial detainee against his will to render him competent to stand trial and holding that, in part because of psychiatry's compliance with the result, "no established ethical barriers render such treatment medically inappropriate for weston at this time.;. 205. see jurasek v. utah state hosp., 158 f.3d 506,515 (loth cir. 1998)(findingthata statute mentioning obtaining a guardian's consent prior to administering medical treatment to an incompetent patient did not create a liberty interests beyond harper and thus was not required). 156 indiana health law review [vol. 2:117 troubling when it makes the inmate sane enough to execute, arguments against it are a rather transparent attack on the death penalty itself. the better rule is that autonomy is not absolute. 206 finally, it is important to explain that medicating singleton is not ''parti­ cipation" in an execution.207 if prescribing medically needed drugs for a death row inmate that may render him competent for execution is "participation," then really any involvement, however tangential, in the justice system could become a "but for" cause of the ultimate result. the american medical association's council on ethical and judicial affairs has defined participation in execution to include actions that directly cause death or help another person directly cause death.208 the action here does not fit that definition. the chain of causation is too attenuated in the singleton situation to plausibly argue that physicians are acting as executioners or government lackeys. if a psychiatrist does not become an agent of the state when medicating a defendant for the sole purpose of making him competent for trial, why does that physician now become the executioner's handmaiden ifhe or she medicates an inmate for the sole purpose of treating the illness, with the acknowledged potential side­ effect that the inmate may become competent to be killed?209 it is illogical to draw a line at the physician who treats the underlying psychosis. that behavior is more tangential than the crime itself, the court's decision on 206. it may help to think of the situation as not one about mental illness, but rather, one that turns on competency. in the vast majority of cases, and certainly on death row, medical protocol is to treat the underlying cause of the delusions or delirium and restore the patient to competence. in singleton's case, the underlying illness is schizophrenia. but incompetence can be brought on by organic problems that affect the brain, like hepatic encephalopathy, where the underlying illness could be liver failure, or a metabolic derangement, where the underlying illness could be diabetic ketoacidosis. today, mental illness is just as treatable, in many cases, as other diseases that lead to incompetence. the acute derangement is reversible. therefore, it merits treatment. 207. even ifit were, physician participation in executions may be ethically acceptable. see kenneth baum, "to comfort always": physician participation in executions, 5 n.y.u. j. legis. & pub. pol'y 4 7 (cogently explaining the parameters of"participation" and arguing that physician participation in executions is ethically permissible). 208. couns. on enncal & juo. aff, supra note 198, at e-2.06. 209. but see george j. annas, moral progress, mental retardation, and the death penalty, 347 new eng. j. med. 1814, 1817 (2002)(''physicians could understandably decline to participate in this way [to determine if an accused is retarded], even before trial, arguing that their participation in any phase of a proceeding that could end in the death penalty lends legitimacy to capital punishment and thus makes medicine complicit in executions."). in 1980, the american psychiatric association "strongly oppose[ d] any participation by psychiatrists in capital punishment, that is, in activities leading directly or . indirectly to the death of a condemned person as a legitimate medical procedure." am. psychiatric ass'n, apadoc. ref. no. 800002, medical particjpation in capital punishment: posmon statement (1980). the apa argued that "[t]he physician's serving the state as an executioner, either directly or indirectly, is a perversion of medical ethics and of his or her role as healer and comforter." jd. this article refutes that position-the physician is treating a patient in desperate need of care instead of letting him wallow in psychosis, just as he would treat any non-death row patient. 2005] involuntarjl y medicating tile psychotic inmate 157 appropriate punishment, the appeals courts' sanction of the death penalty, the supreme court's refusal to hear the case, and the governor's refusal to issue a stay. (iii) physicians should not use "ethics" to inject the austerity of medicine into the justice system courts rely on physicians to remain detached from legal issues and adhere to their role as objective professionals focused on medical treatment. importantly, the legal system, along with the medical community and society itself, expects doctors to treat patients only for a medical purpose, not for a punitive one. as the court said in harper, ''we will not assume that physi­ cians will prescribe these drugs for reasons unrelated to the medical needs of the patients[.]"21° further, in sell, even as the court diluted the harper position on dangerousness, it left medical appropriateness as a crucial part of the test for involuntary treatment. again, the court looked to physicians' judgment. that focus ultimately serves as a check on the government-and an important protection for the inmate-because it assumes that physicians will not advocate for a political or legal position. rather, he or she will prescribe what is medically best for the patient. as the supreme court said in harper, "an inmate's interests are adequately protected, and perhaps better served, by allowing the decision to [involuntarily] medicate [with psycho­ tropic drugs] to be made by medical professionals rather than ajudge."211 in the context of involuntary medication, the legal system defers to physicians. 212 courts rely on physicians' objective clinical judgments. courts seem to assume that doctors will not prescribe medications for punishment since that behavior steps outside the medical profession's role. courts also rely on physicians to refrain from injecting their political views into medical judgments. for example, physicians in the emergency setting must triage and treat patients accused of and even arrested for heinous crimes. they must refrain from judgment and allow the justice system to take its course. similarly, physicians should not betray their responsibility to care for the prison population by allowing their views on the death penalty to color treatment decisions. 213 the legal system believes that a physician-not a 210. washington v. harper, 494 u.s. 210,222 n.8 (1990). 211. /d. at231. 212. /d. at 230 n.12. ("[d]eference •.. is owed to medical professionals who have the full­ time responsibility of caring for mentally ill inmates ... and who possess, as courts do not, the requisite knowledge and expertise to determine whether the drugs should be used in an individual case."). 213. in sell, the court again reiterated the designated and limited role of physicians and why their focus must remain narrowed on treatment the court explained, for one thing, the inquiry into whether medication is permissible, say, to render an individual nondangerous is usually more "objective and manageable" than the inquiry into whether medication is permissible to render a defendant competent. 158 indiana health law review [vol. 2:117 judge or a warden or an advocate-can make a dispassionate decision about ·medical treatment, guided by evidence, that focuses narrowly on the clinical issues involved in the case. the system relies on physicians to·refrain from · expanding their role into politics or policy. it needs doctors to ~ ~ 4octors '-"-not politicians, puppets of the warden, or even death penalty oppqd.ents. it depends on it. (iv) political opinions should be expressed through the democratic process aside from the singleton setting, physicians should not deliberately act to foil the justice system in other contexts. the need to call medicating singleton .. a breach of ethics" highlights the contentiousness: of the death penalty and some physicians' reluctance to be associated with it, even tan. -gentially. however, due process was served at every step in singleton's case, and any discomfort with the outcome becomes a problem with our legal system or the death penalty itself. the way to express disaffection for either the justice process or singleton's punishment is not to retreat into .. ethics," ·nor is it to include the totality of the circumstances in decisions about medical treatment. such approaches fail on legal, ethical, and policy grounds and trump the justice system on a haphazard case-by-case basis. not only is this an unprincipled strategy for expressing resentment towards the death penalty, it is not the appropriate use of physicians' considerable power. we have a democratic system. it may be flawed, but it is not a totali­ tarian government. it is not nazi germany, and any comparison to physicians' roles in that regime is wrong, insulting, and dangerous. that was a system where religion, race, and sexual orientation, among other classifications, served as an excuse to violate individual rights-exactly the kind of prejudices that our constitution aims to protect. our courts have charged physicians with the weighty responsibility of guiding medical care for incompetent inmates. doctors should not reconfigure and expand that role to act as the legislature, the judiciary, or the executive branch of government, creating law, interpret­ ing law, or deciding clemency. it is not their role; it is not their place. we have political venues to challenge the death penalty, and physicians who disagree with it should use those avenues to express their displeasure. but they should not usurp that system, encroach on powers delegated to particular the medical experts may find it easier to provide an informed opinion about whether, given the risk of side effects, particular drugs are medically appropriate and necessary to control a patient's potentially dangerous behavior (or to avoid serious harm to the patient himself) than to try to balance harms and benefits related to the more quintessentially legal questions of trial fairness and competence. sell v. united states, 539 u.s. 166,213 (2003) (internal citation omitted). 2005] involuntarily medicating the psychotic inmate 159 branches of government, work outside of the democratic process and, rather presumptuously, call it medical ethics. ill.· given that the singleton decision is legal and ethical, options for physicians who disagree. law and ethics may allow medicating inmates like singleton, but for many physicians, the onus of that task may be too much to bear. the profes­ sion has long wrestled with the ethics of its association with the death penalty,214 and the singleton controversy likely reveals deep discomfort with capital punishment itself. for physicians who remain wary of treating a patient when successful therapy may mean certain death, alternatives exist. a. optout unless they are on an emergency team, physicians can choose their patients and procedures. a court cannot demand that a surgeon perform surgery, and it cannot order an obstetrician to terminate a pregnancy. similar­ ly, psychiatrists may alleviate any inner conflict by opting out of treating death row inmates. psychiatrists who work for the state should also be allowed to opt out, as the ethics committee of the american psychiatric association has suggested.215 regardless of cogent arguments to the contrary, some physicians may feel that the death penalty demands distinction and that forcibly medicat­ ing an inmate who faces imminent execution makes them complicit in capital punishment. reasonable people disagree about the point where complicity begins and if participation is unethical. physicians who remain uncomfortable with forced medication in cases like singleton can and should decline to care for this class of patient; and they should do so consistently, without regard to a particular crime or personality. of course, if the most conscientious physi­ cians refuse to care for inmates sentenced to death, their dissent may leave prisoners with inferior or absent care. b. rescind ford although ford is grounded in the common law and the opinion of esteemed supreme court justices, it is not truth-incontrovertible and 214. am. psychiatricass'n, supra note 209 (noting that .. in this century heinous crimes by physicians causing death and torture have been documented in germany, russia, and other countries"); see also am. coil. of physicians et al., supra note 197 (detailing the history of physician participation in capital punishment, including their efforts to make execution more humane and less painful). 215. interview with dr. howard zonana, professor of psychiatry and clinical professor (adjunct) oflaw, yale university, in new haven, conn. (feb. 18, 2005). 160 indiana health law review [vol. 2:117 irrefutable. it is opinion bounded by mores of a particular time and place. it may, in fact, be wrong.216 the rationales for not killing the insane may be little more than historical relic. in their book about alvin ford (of the ford competence standard), kent miller and michael radelet explain why our society refrains from killing the mentally i11.217 first, from a humanitarian perspective, the mentally ill deserve special protection. they cannot care for themselves, and their illness is punishment enough. arguably, though, the insane deserve no more protection than anyone else, and although their illness may be unpleasant or even horrifying, it is not what the state meted out. second, killing the insane clouds the image offair play that is crucial to our justice system. since a mentally ill individual cannot assist in his defense, the system takes advantage of him. this argument is less convincing when, like singleton, the defendant becomes ill after the trial. attorneys like jeffrey rosenzweig serve as excellent advocates, with or without their client's input. third, miller and radelet note that retribution is not achieved if the prisoner fails to appreciate his impending fate. yet, even if he fails to understand the reason for his execution, he becomes an example for others, adding to the deterrent value of the punishment, and the family ofhis victim appreciates the retributive nature of his death. further, an argument based in religious conviction says that the insane prisoner awaiting execution is unable to prepare for death. but that is a fate that befalls many non-criminals too. sudden illness or unexpected trauma is tragic. if the issue turns on adequate time to prepare for the afterlife, it becomes just another reason to separate religion from the state. finally, the authors note that society may be horrified by our inability to show mercy to the mentally ill, and that the prisoner's death will be overshadowed by such callousness. if that is so, it is unclear why we fail to show mercy to others with non-mental illnesses. today, we know that mental illnesses like major depression, schizophrenia, and bipolar disorder are examples of neuro­ chemistry gone awry. why is this class of disease any different from other diseases where organs malfunction, like cancer, heart failure, huntington's disease, or cirrhosis? psychiatrists argue that depression is akin to diabetes. it is a medical disease that should be without stigma. but giving special status to mental illnesses supports that stigma. if mental illnesses are no different from any other disease, they should be treated like any other disease. not long ago, the california supreme court wrote that insanity and execution were not mutually exclusive. 216. see, e.g., phyle v. duffy, 208 p.2d 668, 675 (cal. 1949) (traynor, j., concurring) ("taking refuge in insanity as a means of escaping execution is not a constitutional right, but a privilege that the state has conferred as an act of mercy or special dispensation."). 217. kents. miller & michael l. radelet, executing me mentally iu.: the criminal justice system and me case of alvin ford 2 (1993). 2005] involuntarh... y medicating the psychotic inmate a study of the historical background of the cited statutes does not disclose that a convicted person, who may become insane · following his conviction, has any constitutional or inherent right to have the execution of his sentence suspended by reason of such insanity. at common law the granting of an application for such suspension appears to have been discretionary with the court or the executive power in the exercise of [clemency], as a merciful dispensation, an act of grace. in such cases there was no absolute right to a hearing and the ruling of the trial court was not subject to review by appeal.218 161 professor henry weihofen has argued that it may be more humane to execute prisoners while they are insane, to spare them the terror of waiting· for death.219 as he put it, "[t]he real issue is whether it is less humane to execute a guilty criminal while he is insane than it is to postpone the execution until we make sure that he understands what we mean to do to him-and then kill him."22° california's justice traynor asked a compelling question: is it not an inverted humanitarianism that deplores as barbarous the capital punishment of those who have become insane after trial and conviction, but accepts the capital punishment of sane men, a curious reasoning that would free a man from capital punishment only if he is not in full possession ofhis senses?221 but for stare decisis, there is little reason why perspectives like these cannot shape the rule of the day. if ford vanished, physicians' conflict in cases like singleton would also disappear. still, the normative value of ford and its deference to a core standard of human decency remains. c. clarify and heighten the competence standard singleton's state of mind calls into question the usefulness of the ford standard. the bar may be too low. as university of florida levin college of law professor christopher slobogin explained on abc's nightline, "[ s ]orne people can repeat back to one in a rote, parrot-like manner[,] ['y]es, i under­ stand the death penalty means i will die and yes, i understand that's because i killed someone.['] but," he continued, ''unless the person really has a clear 218. people v. riley, 235 p.2d 381,384 (cal. 1951). 219. henry weihofen, a question of justice: trial or execution of an insane defendant, 37 a.b.a. j. 651 (1951). 220. /d. at 652. 221. phyle, 208 p .2d at 676-77 (traynor, j ., concurring). 162 indiana health law review [vol. 2:117 appreciation of why he or she is being executed, then we don't [execute him]. one court put it this way. unless the person quails at the imposition of the death penalty we shouldn't impose it on them."222 states suspend executions until the inmate regains compet~nc~, 223. but the standard could be changed so that inmates with mental illnesses would be immune from execution. inmates, like singleton, who understand the point and nature of execution may suffer from chronic illness: "the voic.es inside charles singleton's head vary, in volume and number, regardless of whether he iuis taken medication for his schizophrenia inside his arkansas cell, he says he can often hear voices that speak of killing him."224 if society is uncomfortable with killing mentally ill inmates, then the competency standard as the threshold for execution may need to be altered. , further, competency determinations may be overly subjective. prof­ essor bruce winick argues that ''the criteria used to define [mental illness] are ... imprecise and their application inevitably involves value judgments, often beyond the professional competence of clinicians.''225 although attempts have been made to make the evaluation objective, it may not be impartial enough.226 even so, the treatable nature of the manifestations of some mental illnesses means that only the most refractory patients will fall outside of competency boundaries. in that case, we may need to become comfortable with executing inmates who have underlying mental illnesses, just as they may have other underlying chronic diseases. d. commute sentences to abolish the death penalty for the insane capital punishment still enjoys wide public support among americans. a gallup poll conduct in october 2003 found that almost two-thirds of americans surveyed supported the death penalty.227 but when asked about executing mentally ill inmates, opinions changed. according to a poll of 1,012 americans taken in may 2002, "75 percent of those surveyed opposed 222. nightline: executing the mentally ill (abc television broadcast, may 19, 1998). professor slobogin is the stephen c. o'connell chair, professor of law, affiliate professor of psychiatry, and associate director, center on children and the law, available at http://www.law.ufl.edu/faculty/sloboginlindex.shtml (last visited apr. 17, 2005) (on file with the indiana health law review). 223. see, e.g., ala. code § 15-16-23 (2005). 224. drew, supra note 55. 225. winick, supra note 79, at 159. . 226. arrigo&williams,supranote135,at374n.28(1999)(listingarticlesondetermining competency); charles patrick ewing, diagnosing and treating "insanity" on death row: legal and ethical perspectives, 5 beha v. sci. & l. 175, 175-85 (1987); patricia a. zapf et al., assessment of competency for execution: professional guidelines and an evaluation checklist, 21 behav. sci. & l. 103, 103-20 (2003) (discussing professionalism issues in psychiatry, creating a checklist towards an "objective assessment of competency for execution"). 227. drew, supra note 55. 2005] involuntarh.. y medicating the psychotic inmate 163 executing mentally ill inmates, while 19 percent supported it. "228 this ambivalence may indicate americans' willingness to move the mentally ill off of death row. courts and legislatures could capitalize on this support to create a bright line rule that commutes death sentences for inmates suffering from mental illnesses. an unequivocal directive protects due process because it puts every­ one on notice about individuals who cannot face execution. it may also be a step toward fairness. perhaps individualized decisions are too whimsical, too uncertain, too dependent on mood and mercy. moreover, it would not be a unique declaration. particular classes of individuals, like the mentally retard­ ed, are immune from capital punishment.229 similarly, we could extend that protection to another group. such a law would also eliminate the psychia­ trist's dilemma, as medication and execution competence would be untangled. perhaps such a rule would make our society more humane. as singleton's attorney has argued, "[i]t offends social standards of decency to execute someone whose competency has been involuntarily obtained. "230 to be sure, a ban on executing prisoners with mental illness would fall in line with international standards. as amnesty international reported, "in 1997, the un special rapporteur on extrajudicial, summary or arbitrary executions stated that governments that continue to use the death penalty 'with respect to minors and the mentally ill are particularly called upon to bring their domestic legislation into conformity with international legal standards."'231 in april 2000, the un commission on human rights urged all states that maintain the death penalty "not to impose it on a person suffering from any form of mental disorder; not to execute any such person."232 according to amnesty inter­ national, imposing capital punishment on individuals with a mental illness "is clearly prohibited by international law. virtually every country in the world prohibits the execution of people with mental illness."233 yet, the rule is not impervious to criticism. it remains unclear why criminals with mental illnesses deserve special treatment ifhe can understand the nature of and reason for his punishment. the rule rewards neurobiology gone awry. in a very real sense, the rule is unfair to those who are not insane as well as those who suffer from a general medical illness. also, prisoners 228. !d. 229. atkins v. virginia, 536 u.s. 304, 321 (2002) (holding that death is an unconstitu­ tionally cruel and unusual punishment for mentally retarded criminals). 230. rachel o'neal, sanity dose approved for inmate court rules state can medicate killer to make him fit for execution, ark. democrat-gazetie, june 18, 1999, at al. 231. amnesty international usa, death penalty facts: the death penalty kills the mentally lll, at http://www.amnestytisa.orglabolish/mental_illness.html (last visited apr. 17, 2005) (on file with the indiana health law review). 232. id. 233. !d. 164 indiana realm law review [vol. 2:117 could attempt to feign mental illness, difficult as that may be, to gain the execution exemption.234 e. physicians who oppose the involuntary medication of inmates like singleton should lobby to eradicate the death penalty attempts to mold principles of medical ethics into a coherent, convinc­ ing argument against medicating singleton seem like anti-death penalty senti­ ment and attempts to hide behind the cloak of''medical ethics" to usurp the legal process surrounding execution. even the american medical associa­ tion's code ofethics concludes that "[i]fthe incompetent prisoner is under­ going extreme suffering as a result of psychosis or any other illness, medical intervention intended to mitigate the level of suffering is ethically permis­ sible."235 the arguments underlying physicians' position against medicating prisoners who truly need psychiatric help mask a gut reaction that execution itself, or executing the mentally ill, just feels wrong. at its core, the debate reveals a deep discomfort with the death penalty. if it is barbaric to execute the insane, unethical to forcibly treat inmates who become competent for execution when medicated, unsavory to let people wallow in psychosis to avoid execution, and unprincipled to commute the sentences of those who have the mixed fortune ofbecoming psychotic, the only consistently fair solu­ tion may be to eliminate the death penalty altogether. physicians, including psychiatrists who side with judge heaney in the eighth circuit's decision in singleton v. norris should take a clear and consistent approach and ask legislatures and courts to abolish capital punishment. psychiatrists would find easy allies. the death penalty itself remains controversial. 236 among the more august and fierce opponents of the death penalty, justice william j. brennan, jr., called capital punishment ''uniquely degrading to human dignity."237 benjamin n. cardozo school of law 234. although mental illness may be difficult to simulate, literary and historic examples illustrate its appeal. the bible's king david. shakespeare's hamlet, and ovid's ulysses all feigned madness to avoid one fate or another, as did russian revolutionary kamo and arabic scientist and mathematician abu ali ibn al-haytham. see margaret macmillan, paris 1919: six months that changed tim world 209 (2001 ); museum victoria australia, scientists & discovery: abu ali ibn al-haytham, at http://www.museum.vic.gov.aulscidiscovery/ scientists/al_haytham.asp (last visited apr. 17, 2005) (on file with the indiana health law review). 235. couns. on etiiical & jun. aff, supra note 198, at e-2.06. 236. stuart taylor, the death penalty debate intensifies, newsweek web excwsive, june 11, 2001 (discussing shifts in public opinion and presidential rationales for the death penalty); see also beyond repair?: .america's death penalty 2 (stephen p. garvey ed., 2003) (discussing trends in support for the death penalty); f'rank g. carrington, neither cruel nor unusual (1978) (defending the death penalty and its necessity in society). 237. glassv. louisiana,471 u.s. l080(1985)(brennan,j., withwhommarshall,j.joins, dissenting from denial of certiorari) (citing furman v. georgia, 408 u.s. 238, 287-91 (1972)) (internal quotations omitted). 2005] involuntarll...y medicating the psychotic inmate 165 professor barry scheck continues to uncover evidence of erroneous convic­ tions of death row inmates through his innocence project.238 in 2000, illinois governor george ryan declared a moratorium on executions in his state after dna evidence exonerated a number of inmates. 239 other professional associations have taken such a stance. the american bar association has concluded that ''the death penalty is administered in an unfair and arbitrary manner'' and the group recommended a moratorium on executions until the system is changed. 240 the american psychiatric association also endorses a moratorium ''until jurisdictions seeking to reform the death penalty implement policies and procedures to assure that capital punishment, if used at all, is administered fairly and impartially in accord with the basic requirements of due process."241 but the association stopped short of adding teeth to its decree: "the statement, prepared by the council on psychiatry and the law, was approved as amended, with the proviso that the language is intended neither as an endorsement nor a statement of disapproval of the death penalty."242 similarly, "[t]he ama has a 'long-standing tradition to remain neutral on matters that are considered to be non-medical. "'243 these groups should take a stand on the death penalty. all physicians should participate in the ongoing debate about the appropriateness of capital punishment. 244 what makes the most sense, though, is to end the system that endorses accidents of biology and protects certain classes from the death penalty, and eliminate the punishment itself. physicians who oppose treating singleton should lobby against the death penalty. while the supreme court holds that capital punishment is constitutional, that position may change. because the court looks to prevailing social norms and public values when considering the 238. hmocenceproject,athttp:/lwww.innocenceproject.org(lastvisitedapr.l7,2005)(on file with the indiana health law review). 239. franco ordonez, death row appeal challenges rule limiting filings, boston globe, feb. 24, 2004, at al (mentioning the lllinois moratorium on executions). of course, governors, like the american population, take varying positions on the issue. minnesota governor tim pawlenty wants to resurrect the death penalty in his state-that state'slegislature repealed the penalty in 1911--but pawlenty wants to implement safeguards like a requirement for dna evidence, a ban on executing minors and the mentally disabled, and a requirement that death may not be imposed if the prosecution based its case on one eyewitness's testimony, an informant's testimony, or uncorroborated accomplice testimony. national briefing, mujwest mmnesota: return of death penalty, n.y. times, jan. 28, 2004, at al9. 240. am. psychiatric ass'n., ap a doc. ref. no. 200006, moratorium on capital punishment in the u.s.: position statement (2000), available at http://www.psych.org/edu/other _ resllib _ archiveslarchives/200006.pd£ 241. id. 242. id. 243. jim ritter, ama opposes scouts' gay ban, chicago sun-times, june 21, 2001, at 14. 244. see annas, supra note 209, at 1817 (discussing physicians' "special ethical responsibility to participate actively in the ongoing debate over capital punishment"). 166 indiana health law review [vol. 2:117 scope of the eighth amendment, 245 professional opinions that critique capital punishment may impact the judiciary. they could also (perhaps more appro­ priately) influence law-making in the legislature. a consensus that the death penalty is cruel and unusual could eliminate capital punishment altogether­ and the dilemma for physicians would disappear. physicians could then medicate individuals who need psychiatric or medical care while they are incompetent without worrying about capital punishment. the white ·coat would remain pristine. anything less is tortured logic masquerading as medical ethics. n. epilogue at the beginning of its october 2003 term, the united states supreme court denied singleton's final writ of certiorari.246 it was the final obstacle between singleton and the executioner's needle. the quest for exoneration, or at least a permanent stay of execution, was over. as the hour of execution approached, singleton's attorney asked arkansas governor mike huckabee for clemency, even though his client "had begged him not to do anything to stop the execution. "247 huckabee denied that request. 248 245. see atkins v. virginia, 536 u.s. 304, 311 (2002) (remarking that constitutionally based judgments about excessive punishment are to be made on the basis of opinions that "currently prevail" and that the court looks to americans' values and national consensus regarding death penalty issues); ford v. wainwright, 477 u.s. 399,406 (1986) ("[t)his court takes into account objective evidence of contemporary values before determining whether a particular punishment comports with the fundamental human dignity that the amendment protects."); trop v. dulles, 356 u.s. 86, 100 (1958) (as chief justice warren explained, "the basic concept underlying the eighth amendment is nothing less than the dignity of man .... the amendment must draw its meaning from the evolving standards of decency that mark the progress of a maturing society."). but see atkins, 536 u.s. at 322 (rehnquist, c.j., dissenting) (declaring his unhappiness with an approach that uses "foreign laws, the views of professional and religious organizations, and opinion polls in reaching its conclusion" rather than legislatures and juries). 246. singleton v. norris, 540 u.s. 832 (2003). 247. traci shurley, singleton dies, ark. democrat-gazette, jan. 7, 2004, at 11. it is ironic that rosenzweig, so opposed to involuntary medication, filed an involuntary appeal. of course, clemency would mean life for singleton, but the involuntariness of the appeal is interesting, nonetheless. 248. ld. shurley reported that the governor's decision "fell in line with a recommendation by the state's post prison transfer board" and reporting that "representatives from the arkansas american civil liberties union and the state office of the national alliance for the mentally lll held a news conference in the state capitol" to pressure the governor's clemency decision. following that event, members of the singleton family tried to meet with the governor to discuss the case. singleton's younger sister, denise hipps, told shurley, "'only god or the governor can stop this .... we're already talking to god, the next step is to talk to [the governor]."' previously, a staff member from the governor's office had spoken with the family, and the governor turned them away-the usual practice regarding meetings with relatives of applicants for clemency. the family had argued that singleton was "incompetenf' and therefore should not be executed. 2005] involuntarily medicating the psychotic inmate 167 unquestionably, singleton remained mentally ill as his execution approached. in an interview with cnn the week before his death, singleton spoke about the voices that haunted him. 249 he explained, "they talk about, for example, '[l]et's hold him and see when his father come. we'll have him and his father.' they talk about ruling the world and finding a way to kill me."250 even his final statement seemed confused or perhaps pious: "the blind think i'm playing a game. they deny me, refusing me existence. but everybody takes the place of another. as it is written, i will come forth as you go."251 as cnn reporter brian cabell explained, "[l]s this man sane as }le approaches his execution? i can tell you, we met with him on death row just week ago, as a matter of fact. he is not like you or me. he rants. he raves. he rambles. he occasionally loses his train ofthought."252 but singleton's ongoing battle with schizophrenia did not preclude him from competence under ford.253 as cabell reported: but on the narrow definition of sanity that applies here, does · he understand what is going to happen to him, does he under­ stand why, the answer would certainly be. yes. he under­ stands that he is going to be executed. he understands it's because he killed a woman some 24 years ago. even his attorney would agree to that. 254 indeed, rosenzweig said that singleton ''was generally in the past several months saner, more stable and more rational than he had been in a long time, as long as i've known him."255 because he understood that he killed mary lou york and that his punishment was death, his execution would be carried out. so the singleton saga reached its inevitable end with fried eggplant, fried green tomatoes, fried sweet potatoes, two double cheese veggie burgers with barbecue baked beans, potato salad and two cokes. 256 it was the first last meal of2004 for arkansas,257 and it was a dinner that the state had been 249. cabell, supra note 170. 250. /d. 251. shurley, supra note 247, at 11. 252. paula zahn now: is america safer?; princess diana's conspiracy theory (cnn television broadcast, jan. 6, 2004). 253. ford v. wainwright, 477 u.s. 399 (1986). 254. paula zahn now, supra note 252. 255. shurley, supra note 247, at 11. 256. id at 11 (detailing singleton's last meal). 257. see death penalty information center, executions in the united states in 2004, at http://www.deathpenaltyinfo.org/article.pbp?scid=8&did=839 (last visited apr. 17, 2005) (on file with indiana health law review). 168 indiana heal til law review [vol. 2:117 waiting to serve for 21 years, six months and two days. 258 it had taken decades, but due process was met, the sentence was constitutional, and the journey would end on january 6, 2004, sometime after dessert-glazed dough­ nuts and two vanilla milkshakes.259 at 8:06p.m. that evening, arkansas finally executed charles laverne singleton, a man who had lived on that state's death row longer than anyone else in its history, by lethal injection.260 singleton came full circle, ending up exactly where he started-in the execu­ tion .chamber. fourteen people watched him die,261 including his attorney rosenzweig and prosecutor john gibson, and, according to those witnesses, singleton went quietly to his death.262 one's perspective necessarily colors the meaning of singleton's execu­ tion. singleton was said to have welcomed death because he was ''tired of this world"263 and, according to rosenzweig, ''tired of living with mental illness."264 that sentiment marked a change for singleton. just a few years ago he told an interviewer, "i don't want to die. i want to live. but i know there's a possibility that i will die."26s rosenzweig, who had represented singleton in all ofhis appeals, "described himself as 'frustrated, disappointed, saddened' by the execution,"266 calling it "a shameful mark on the state of arkansas, because we're talking about the execution of someone who was clearly mentally i11."267 perhaps the york family members found whatever 258. singleton v. lockhart. 653 f. supp. 1114, 1115 (e.d. ark. 1986}(noting singleton's original execution date). 259. shurley, supra note 247, at 11. 260. ld. (''charles singleton, the state's longest-serving death-row inmate, was executed as planned tuesday. he was pronounced dead at 8:06p.m.'"). 261. 14 observe state's execution of singleton, ark.democrat-gazetie, jan. 7, 2004, at 15. the names and affiliations of the witnesses: ld drew baker, arkansas department of correction board member; brett morgan of little rock; gary canda of england; eric walker of the state attorney general's office; john f. gibson jr. of monticello, who prosecuted singleton; thomas smith ofengland; harold pointer ofpine bluff; griffin smith, executive editor, arkansas democrat-gazette; state sen. jimmy jeffi'ess, d-crossett; jeff rosenzweig, singleton's attorney; and gaylon white, singleton's spiritual adviser. members of arkansas media allowed to attend for the purpose of news coverage were: david hammer, the associated press; jason friedman, kark television station, little rock; and warren watkins, ashley county ledger­ menastar. 262. live from . . . :execution debate rages on, (cnn television broadcast, jan. 7, 2004). 263. paula zahn now: interview w'uh senator john kerry and teresa heinz kerry; pete rose admits beuing on baseball (cnn television broadcast, jan. 5, 2004). 264 .. drew, supra note 55. 265. dateline nbc: crazy like a fox?, supra note 4. 266. cabell, supra note 170. 267. live from . .. :execution debate rages on (cnn television broadcast, jan. 7, 2004). other mentally ill inmates have faced execution. according to amnesty international: [a]s recently as january 21, 2000, larry keith robison, diagnosed with 2005] involuntarily medicating the psychotic inmate 169 peace they were looking for as they watched the execution over closed-circuit television. 268 as mary lou york's son charles predicted about the eventual execution, "[i]t would bring closure for my brothers and sisters and i. it destroyed our family bad enough as it is ... 269 for the medical community, the legal system, and the public, the lesson of the case remains in flux. 270 charles singleton died at age 44. his death was shocking and unsur­ prising. after all those years, singleton seemed invincible, out-foxing his opponents at every turn. he could always find another issue to parry and riposte, just one more time. in the context of appeal after appeal after appeal, he had seemingly become the protagonist. singleton versus the state. and in stories of epic legal battles, doesn't the protagonist always win? though the singleton case has ended, its legacy is a paradox. i believe in the arguments set forth here. i believe that psychiatrists have an ethical duty to medicate prisoners in clinical situations like that of charles singleton. i believe that psychotic inmates deserve treatment, the kind of care that they would get in the outside world, and that psychiatrists should not deny that treatment because the inmate may become competent for execution. but that does not mean that i would have cheered at singleton's execution, nor would schizophrenia, was executed by the state oftexas. on june 22, 2000, thomas provenzano, who suffered from severe delusional episodes and believed he was jesus christ, was executed by the state of florida. on august 16, 2000, john satterwhite, who suffered from both mental illness and mental retardation, was executed by the state of texas. others with mental illness who have been executed in the u.s. in violation of international law include: pernell ford (alabama); bert hunter (missouri); and juan soria (texas). amnesty international usa, death penalty facts: the death penalty kills the mentally ill, at http://www.amnestyusa.orglabolish/mental_illness.html(lastvisitedapr.l7,2005)(onfilewith the indiana health law review). presumably, these inmates met the ford standard for competence. 268. 14 observe state's execution of singleton, supra note 261, at 15. york's family members who saw the execution via closed-circuit television were: charles york. victim's son; mildred arrington, victim'sdaughter; jerry pryor, victim'snephew; sherry arrington, victim's granddaughter; and dell arrington, victim's granddaughter. 269. dateline nbc: crazy like a fox?, supra note 4. 270. singleton will not be the last case to present the issue of involuntary medication with the byproduct of competency for execution. see abc online, foreign correspondent: u.s.a-death row medication, at http:/lwww.abc.net.aulforeign/stories/s894253.htm (last visited apr. 17, 2005) (on file with the indiana health law review) (providing a synopsis of bbc: u.s.a.-death row medication (bbc television broadcast aug. 7, 2003)). tim samuels reported that: /d. gregory thompson has been on death row at nashville's riverbend maximum security institution for 17 years, convicted for a brutal murder. he tells samuels that he has written all the popular songs on the radio, and also that he is planning to buy homes in hawaii and new yorlc. he also claims to have made millions from the stock market. thompson's defence lawyer is convinced that he is insane, an assessment supported by an independent psychologist, who tells samuels that when not medicated, thompson refuses to clean himself or eat, and believes he is living on a slave ship. 170 indiana health law review [vol. 2:117 i dance on his grave. the reasons that death penalty opponents cite are con­ vincing-killing singleton will not bring back his victim; execution may not deter future killers; a life sentence is cheaper than the requisite appeals by orders of magnitude; given a different lawyer/skin color/jurisdiction, the out­ come would have been different; and so on. to even the most callous observer, the inconsistencies in the punishment and the innocents exonerated from death rows around the country makes capital punishment seem "irra­ tional, arbitrary, and unfair."271 still, i would have treated charles singleton. and yet i remain troubled by the pointlessness of his crime and uneasy with the manner of his death. 271. singleton v. norris, 108 f.3d 872,876 (8th cir. 1997) (heaney, j., concurring). mhealth and unregulated data: is this farewell to patient privacy? j. frazee, m. finley, & jj rohack, md* i. introduction................................................................ 385 ii. the current regulatory scheme ............................ 386 a. agency regulation ...................................................... 386 b. hipaa and mhealth .................................................. 392 iii. user generated health information .................... 394 a. how consumer data is collected ............................... 394 b. how consumer data is used ..................................... 397 1. use by data brokers ................................................ 397 2. use by other entities .............................................. 399 iv. existing policy is inadequate in the mhealth context ........................................................................... 400 a. the fair information practice principles were drafted before big data ............................................................... 401 1. big data and emerging analytical techniques ..... 402 2. big data weakens de-identification ....................... 405 b. compartmentalizing health data ............................. 406 v. removing uncertainty will provide meaningful choices in the mhealth market .................................................. 408 a. “confidential” label provides a meaningful consumer choice ............................................................................... 409 b. voluntary labeling ..................................................... 411 c. labels create legally enforceable standards .......... 412 1. enforcement ............................................................. 413 2. compliance ............................................................... 413 3. exceptions ................................................................ 413 vi. conclusion ................................................................ 414 http://dx.doi.org/10.18060/3911.0021 2016 385 mhealth and unregulated data: is this farewell to patient privacy? i. introduction mobile health, or mhealth is a rapidly expanding industry. globally, the total number of mhealth applications (“mhealth apps”) on ios and android systems surpassed 100,000 in q1 of 2014.1 market revenue for this industry is projected to reach $26 billion by 20182 and the number of mhealth users is projected to reach 1.7 billion worldwide by 2018.3 mhealth is defined as “medical and public health practice supported by mobile devices,” and it is quickly becoming a defining feature of popular technologies such as “mobile phones,… personal digital assistants,… and other wireless devices.” 4 users of mhealth apps produce volumes of data about their health, and this data is highly revealing. several commentators note that the health data produced by patients’ use of mhealth is more revealing than their electronic health record (ehr).5 despite this reality, the vast majority of mhealth apps are not subject to significant regulation. the current regulatory scheme governing mhealth is narrow and only concerns a small fraction of the mhealth market, even including those apps covered by the *j frazee, ba, university of houston school of law; ma finley, jd, llm, vice president, baylor scott & white center for healthcare policy; jj rohack md, the william r. courtney centennial endowed chair in medical humanities, chief health policy officer, baylor scott & white health. 1 research2guidance, mhealth app developer economics 2014: the state of the art of mhealth app publishing 16 (2014) available at http://www.research2guidance.com/r2g/research2guidance-mhealthapp-developer-economics-2014.pdf [https://perma.cc/gfv4-2j5x]. 2 id. at 7. 3 id. 4 who global observatory for ehealth, mhealth: new horizons for health through mobile technologies, 6 (2011), available at http://www.who.int/goe/publications/goe_mhealth_web.pdf [https://perma.cc/pr83-jrnq] (defining mhealth as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (pdas), and other wireless devices.”). 5 see jane sarasohn-kahn, here’s looking at you: how personal health information is being tracked and used 5 ca healthcare found. (2014). 386 indiana health law review vol. 13:2 health insurance portability and accountability act (hipaa)6. this paper investigates mhealth apps that are not subject to fda oversight or hipaa and the privacy issues involved, and ultimately proposes a united states labeling system intended to ensure consumer confidence and stimulate growth in the mhealth market. ii. the current regulatory scheme there are two significant regulatory questions for any mhealth app: (1) whether the app will be subject to agency regulation; and (2) whether the app will be subject to hipaa. beyond this, no federal laws specifically regulate mhealth applications.7 a. agency regulation multiple agencies share regulatory jurisdiction over the mhealth industry, including: the food and drug administration (fda), the office of the national coordinator for health information technology (onc),8 and the federal communications commission (fcc) (hereinafter referred to collectively as “the agencies”). in 2012, congress directed the agencies, in section 618 of the food and drug administration safety and innovation act (fdasia), public law 112-144, to collaborate and issue a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, 6 health insurance portability and accountability act of 1996, public law 104–191, 110 stat. 1936 (codified as amended in scattered sections of 29 and 42 u.s.c.) 104th cong. (1996). 7 u.s. gov’t accountability office, gao-13-663, information resellers: consumer privacy framework needs to reflect changes in technology and the marketplace 19 (2013) [hereinafter information resellers] available at http:// www.gao.gov/assets/660/658151.pdf [https://perma.cc/ba2t-pwlz]. 8 the onc is an office within the department of health and human services and is not an independent agency. 2016 387 mhealth and unregulated data: is this farewell to patient privacy? protects patient safety, and avoids regulatory duplication.9 in fulfilling this charge, the agencies issued the “fdasia health it report: proposed strategy and recommendations for a risk-based framework,” which explains, in part, that the fda will primarily regulate health it with medical device functionality. 10 health it with medical device functionality is used to diagnose and treat illnesses, as opposed to software that supports administrative functions like scheduling and documentation.11 with respect to mhealth applications, the fda explained its regulatory approach in a guidance document entitled “mobile medical applications: guidance for industry and food and drug administration staff.” 12 the current approach is for the fda to focus on a subset of mhealth apps that the agency refers to as “’\mobile medical applications” or “mobile medical apps.”13 an app is determined to be a “mobile medical app” based on two criteria: the app must transform a mobile device into a medical device within the meaning of section 201(h) of the food, drug, and cosmetic act (“fd&c act”), 14 and the app must be intended for use as 9 u.s. food & drug admin., fdasia health it report: proposed strategy and recommendations for a risk-based framework 3 (2014) [hereinafter fdasia report], available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedica lproductsandtobacco/cdrh/cdrhreports/ucm391521.pdf [https:// perma.cc/9zpn-gg3v]. 10 id. at 12. 11 id. at 11-12. 12 u.s. food and drug admin., mobile medical applications, guidance for industry and food and drug administration staff (2015) [hereinafter fda medical application guidance], available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandgui dance/guidancedocuments/ucm263366.pdf [https://perma.cc/2l654npf]. 13 id. at 7 (“…a ‘mobile medical app’ is a mobile app that meets the definition of device in section 201(h) of the federal food, drug, and cosmetic act (fd&c act); and either is intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.”). 14 federal food, drug, and cosmetic act, 21 u.s.c. § 321(h) (2016). section 201 (h) of the food, drug, and cosmetics act defines device as 388 indiana health law review vol. 13:2 a regulated medical device or as an accessory to a regulated medical device.15 if an app qualifies as a mobile medical app, it will be subject to certain regulatory controls, depending on its risk classification.16 there are three device classes. 17 class i devices are generally considered low risk. these devices are usually exempt from premarket approval, although they must adhere to “general controls.” 18 class ii devices are considered moderate risk or present well-understood risks. these devices are generally required to submit 510(k) premarket notification.19 they are also subject to general controls, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 15 fda medical application guidance, supra note 12. 16 id. at 30. 17 medical device amendments of 1976, pub. l. no. 94-295, 90 stat. 539. (1976). 18 21 cfr §§ 800-98 (1999); fda medical application guidance, supra note 12, at 19, general controls include: establishment registration, and medical device listing (21 cfr part 807); quality system (qs) regulation (21 cfr part 820); labeling requirements (21 cfr part 801); medical device reporting (21 cfr part 803); premarket notification (21 cfr part 807); reporting corrections and removals (21 cfr part 806); and investigational device exemption (ide) requirements for clinical studies of investigational devices (21 cfr part 812). 19 u.s. food & drug admin., fda premarket notification 510(k), fda.gov (sept. 16, 2015), http://www.fda.gov/medicaldevices/ deviceregulationandguidance/howtomarketyourdevice/premarketsub missions/premarketnotification510k/default.htm [https://perma.cc/ 7tus-keg9] (device manufacturers are required to prove that the device to be marketed is “substantially equivalent” to another legally marketed device–meaning the new device is as safe as another device with similar functionality that is already on the market). 2016 389 mhealth and unregulated data: is this farewell to patient privacy? well as “special controls,”20 based on the particular device type. class iii devices are high risk or present risks that are poorly understood. these devices are also subject to general and special controls, as well as premarket approval,21 and certain other regulatory controls. mobile medical apps are a small fraction of the overall mhealth market and the vast majority are class i or class ii devices.22 the fda lists 191 medical mobile apps that have cleared the 510(k) approval process as of february 11, 2016.23 the agency claims that this is not a comprehensive list; however, it exceeds the total listed in a comprehensive analysis compiled at the end of 2013 by the industry research group mobihealthnews, which listed the total of approved mobile medical apps at 103. 24 the fda maintains a database that lists approved mobile medical apps, however these apps are listed alongside other devices that have received 510(k) approval and are not uniquely identified as 20 21 u.s.c. § 360c(a)(1)(b). the secretary of health and human services promulgates special controls when determined to be necessary for the assurance of safety and effectiveness. special controls include: performance standards; post-market surveillance; patient registries, special labeling requirements; premarket data requirements; and guidelines. 21 fda premarket approval (pma) http://www.fda.gov/ medicaldevices/deviceregulationandguidance/howtomarketyourdevice/pr emarketsubmissions/premarketapprovalpma/default.htm [https:// perma.cc/73zd-thlv]. see u.s. food and drug admin., supra note 19 (premarket approval uses scientific evidence to ensure the safety and effectiveness of devices that are particularly risky or present poorly understood risks). 22 christy foreman, dir. office of device evaluation, ctr. for devices and radiological health, health information technologies: administration perspectives on innovation and regulation (mar. 21, 2013), http://energycommerce.house.gov/hearing/health-informationtechnologies-administration-perspectives-innovation-andregulation#video (director foreman testified that there had not been a class iii mobile medical application to date). 23 u.s. food and drug admin., examples of pre-market submissions that include mmas cleared or approved by fda, fda (feb. 11, 2016) http://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplicati ons/ucm368784.htm [https:// perma.cc/e3lf-2dln] [hereinafter premarket mmas] (last updated feb. 11, 2016). 24 103 fda regulated mobile medical apps, mobihealthnews (nov. 25, 2013), available at http://mobihealthnews.com/research/103-fdaregulated-mobile-medical-apps/ [https://perma.cc/w2mm-qn8a]. 390 indiana health law review vol. 13:2 apps.25 as a result, approved apps are not easily searchable and may be difficult to identify as apps rather than any other medical device. given the pace of the fda’s approval of mobile medical apps, it is reasonable to assume that the total number of approved apps is near the listed 191,26a small fraction of the more than 100,000 mhealth apps on the market.27 the fda is pursuing this narrow regulatory framework for a variety of reasons. first, the fda is following a riskbased approach,28 with its primary focus on those apps that pose significant risk to patient safety.29 using the risk-based framework laid out by the medical device amendments of 1976,30 the agency categorizes mobile medical apps by class. apps presenting significant risks are sent to market after obtaining the proper approval. second, congress directed the fda to promote innovation in the mhealth industry31 and 25 pre-market mmas, supra note 23. 26 id. 27 research2guidance, supra note 1 at 7. 28 fda medical application guidance, supra note 12 at 3. 29 id. at 8 (2015), (“…we intend to apply this oversight authority only to those mobile apps whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.”). 30 fdasia report, supra note 9 at 5 n.7. the medical device amendments of 1976 created three device classes. the three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective. class i devices are generally low risk. such devices are for the most part exempt from premarket review and are subject–unless exempt–to the requirements for reporting of adverse events, manufacturing and design controls, registration and listing, and other “general” controls. class ii devices generally present moderate or well-understood risks. such devices are subject to general controls and are usually subject to premarket review. class ii devices are also subject to “special controls” that are closely tailored to the risks of the particular device type. class iii devices generally present high or poorly understood risks. in addition to general controls, class iii devices are subject to premarket approval and certain other regulatory controls. 31 id. at 3. 2016 391 mhealth and unregulated data: is this farewell to patient privacy? has expressed concern that regulation could stifle the industry in its infancy. several bills have been proposed to restrict or limit fda regulation over the mhealth industry, including: the medical electronic data technology enhancement for consumers' health act of 2015 (“medtech act”),32 the preventing regulatory overreach to enhance care technology act of 2014 (“protect act”),33 and the sensible oversight for technology which advances regulatory efficiency act of 2015 (“software act”);34 none have been passed by congress. third, stakeholder comments have emphasized that a flexible regulatory scheme is necessary to allow for the development of new technologies.35 with limited resources and significant pushback from both congress and stakeholders, it is not surprising that the fda is conducting a narrow regulatory framework. however, commentators have expressed concern over the fda’s light touch on the industry,36 citing potential danger to patients, or claiming that unreliable technology will inhibit adoption of mhealth by medical professionals, while others assert that more stringent regulation could provide economic benefit to stakeholders.37 32 medical electronic data technology enhancement for consumers' health (medtech) act, s. 1101, 114th cong. (2015). 33 preventing regulatory overreach to enhance care technology act of 2014, s. 2007, 113th cong. (2014). 34 sensible oversight for technology which advances regulatory efficiency act of 2013, h.r. 2396, 114th cong. (2015). 35 fdasia report, supra note 9, at 9. 36 see generally natalie r. bilbrough, the fda, congress, and mobile health apps: lessons from dshea and the regulation of dietary supplements, 74 md. l. rev. 921 (2015) (proposing an “office of mhealth” within the fda to provide greater expertise and further regulate the industry); alex krouse, ipads, iphones, androids, and smartphones: fda regulation of mobile phone applications as medical devices, 9 ind. health l. rev. 731 (2012) (suggesting a decentralized approval process for mhealth devices); daniel f. schulke, the regulatory arms race: mobile-health applications and agency posturing, 93 b.u. l. rev. 1699 (2013) (analyzing various regulatory models and ultimately suggesting a meta-regulatory approach). 37 mobihealthnews research, fda regulation of mobile health 47 (2nd ed.) (on file with the indiana health law review). 392 indiana health law review vol. 13:2 b. hipaa and mhealth the regulatory efforts of the fda are an important first step for ensuring patient safety and promoting the adoption of mhealth in the healthcare industry. however, the majority of mhealth apps operate unencumbered by significant regulation. beyond the fda’s regulation of mobile medical apps, mhealth apps face one significant regulatory question: when is an mhealth app subject to hipaa? 38 hipaa rules only apply to “covered entities” and their “business associates.” 39 a covered entity is defined as a health plan, healthcare clearinghouse, or healthcare provider.40 a business associate is a person, subcontractor, or organization that receives or transmits “protected health information” on behalf of a covered entity or the business associate. 41 protected health information (phi) means individually identifiable health information.42 an mhealth app is subject to hipaa if it receives or transmits a patient’s phi or is used by a covered entity or business associate.43 phi is created in the context of patient care and apps that store or transmit that information are subject to hipaa. on the other hand, apps that are consumer oriented manage user-generated information that is not hipaa protected, such as the calories in one’s meal or the amount of steps one has taken on a given day. as long as an mhealth app does not deal in phi or communicate with a covered entity or business associate it is not subject to hipaa. additionally, de-identified information is not subject to hipaa protection.44 38 health insurance portability and accountability act of 1996, pub. l. no. 104-191, 104th cong. (1996). 39 45 c.f.r. § 160.103 (2016). 40 id. 41 id. 42 id. 43 adam h. greene, when hipaa applies to mobile applications, mobihealthnews (june 16, 2011), http://mobihealthnews.com/ 11261/when-hipaa-applies-to-mobile-applications/ [https://perma.cc/ z2k5-5dr9]. 44 dept. health & human svcs., guidance regarding methods for deidentification of protected health information in accordance with the health insurance portability and accountability act (hipaa) privacy 2016 393 mhealth and unregulated data: is this farewell to patient privacy? for example, “bob” is concerned that he might be an alcoholic and has been clinically diagnosed with depression. bob uses a blood alcohol content calculator on his smart phone to help moderate his drinking and a mood-tracking app that allows him to enter his mood at a given time and track fluctuations. two recently launched startup companies produced these apps and neither shares information with covered entities. the data collected by these companies is not subject to hipaa, even though both of the companies’ databases identify bob by name and include a listing of his unique mobile identification number. bob’s self-regulation is not going well, so he goes to visit a physician at a nearby clinic. the physician prescribes bob with anti-depression medication. at the physician’s recommendation, bob downloads a hipaa compliant telehealth application that allows bob to video chat with his physician rather than drive in to the clinic on a regular basis. bob consults with his physician using the telehealth app once a month until his condition improves and his treatment ends a year later. the data collected by the telehealth app is subject to hipaa regulation because bob uses the app to consult with a healthcare provider (i.e. a covered entity). bob’s communications with his physician are protected by the hipaa privacy and security rules.45 however, bob’s entries in his smartphone using the blood alcohol content calculator and mood-tracking apps are not protected by such rules. both apps were free to download and bob agreed to their terms and conditions without reading their privacy policies, a common consumer practice.46 the privacy policies for both apps state that data collected will be sold to third parties for marketing purposes. while bob views his past rule (2012), [hereinafter de-identification guidance] http:// www.hhs.gov/hipaa/for-professionals/privacy/special-topics/deidentification/#rationale [https://perma.cc/8htw-j9ly]. 45 see 45 c.f.r. part 160 and part 164, subparts a and 45 c.f.r. §§ 160.101-160.552, 164.102-164.534 (2013). 46 sdl, marketing data and consumer privacy: what your customers really think 3 (feb. 26, 2014), available at http:// www.scribd.com/doc/214108509/sdl-marketing-data-and-consumerprivacy-what-your-customers-really-think [https://perma.cc/j3exmf73]. in a survey of more than 4,000 individuals, 65% of respondents reported that they rarely or never read privacy policies before making online purchases. 394 indiana health law review vol. 13:2 year as a success, he considers both his struggle with alcohol and depression deeply personal. unbeknownst to bob, he has documented both in great detail and his user generated health data can now be sold as a commodity on the open market through a system of data brokers. iii. user generated health information like bob in the above hypothetical, real-world persons are generating volumes of sensitive health data and signing it away as a commodity without fully understanding the implications. while mhealth apps and the services they provide can help users manage personal health, third party exploitation of that data may violate patient privacy and cause a chilling effect on the adoption of this useful technology. a. how consumer data is collected a study by evidon, an analytics firm (now restructured as ghostery, inc.), found that the top twenty mhealth apps sold “information to up to [seventy] third party companies.” 47 another study, conducted by privacy rights clearinghouse, analyzed forty-three popular wellness apps for technical security risk and found that twenty of these apps transferred individually identifiable information about its users to third parties.48 the study also found that approximately half of the apps analyzed published a privacy policy and complied 47 emily steel & april dembosky, worriedwell online have new symptom to fear, cnbc: fin. times, (sept. 1, 2013), available at http://www.cnbc.com/id/101002123 [https://perma.cc/22gd-5w9m]. 48 craig michael lie njie, technical analysis of the data practices and privacy risks of 43 popular mobile health and fitness applications, privacy rights clearinghouse 7 (july 15, 2013) available at https://www.privacyrights.org/sites/privacyrights.org/files/ccpfsmartphonehealthapps-technicalreport-final-july152013%281%29_0.pdf [https://perma.cc/3ygy-q2gc]. the study ranked apps by risk level, indicating that apps with a risk level of 5 or higher transferred individually identifiable information to third parties. the study lists twenty apps at risk level 5 or higher. therefore twenty of the apps studied transferred individually identifiable information to third parties. http://www.cnbc.com/id/101002123 2016 395 mhealth and unregulated data: is this farewell to patient privacy? with it.49 in light of these two studies, the federal trade commission (ftc) decided to run a similar experiment. analyzing twelve mhealth apps, the team found a number of personal details were being transmitted to third parties.50 for example, “22 third parties received additional information about our consumers such as exercise information, meal and diet information, medical symptom search information, zip code, gender, geo-location.”51 these studies point to a broad trend of data sharing, with few limitations on what type of data service providers are willing to sell or share with third parties. a 2015 study mirroring the techniques used by privacy rights clearinghouse and the ftc analyzed several categories of apps and similarly found mhealth apps sharing information with third parties52. however the researchers observed only three of the thirty mhealth apps tested sent medical information to third parties.53 while this finding is significantly lower than the ftc report and privacy rights clearinghouse study, it is unclear why this difference exists.54 alongside this observation, the study notes that on the android platform “health & fitness and communication apps sent sensitive data, mostly [personally identifiable information] data, to more third-party domains than apps in other categories,” while ios apps did not similarly stand out 49 id. at 20. 50 spring privacy series: consumer generated and controlled health data, fed. trade comm’n 26 (2014), available at https://www.ftc.gov/system/files/documents/public_events/195411/2014_ 05_07_consumer-generated-controlled-health-data-final-transcript.pdf [ https://perma.cc/3yh5-bpdn]. 51 id. at 27. 52 jinyan zang et al., who knows what about me? a survey of behind the scenes personal data sharing to third parties by mobile apps, tech. science (oct. 30, 2015), http://techscience.org/a/2015103001 [https://perma.cc/6yhf-bfn8]. 53 id. 54 this anomalous finding may be due to the sample size, the research methods (this research group did not use wireshark or tcpdump to monitor non-tcp traffic, while privacy rights clearinghouse did), or changing attitudes among app developers toward privacy implications. there is no clear explanation for the difference in this study and others that indicate broad sharing of behavioral data. 396 indiana health law review vol. 13:2 by category. 55 among the mhealth apps tested, nearly all shared information with third parties that the researchers deemed sensitive, including personally identifiable information, behavioral data, and location data.56 several commentators note that the data revealed by patients’ digital footprint is more revealing than their ehr.57 a physician is only able to test a finite number of variables during a patient visit, whereas mhealth apps continuously monitor patients’ habits. furthermore, much of the data collected occurs without the user being involved or aware that a data transmission has taken place.58 a qualitative study conducted by the international institute of communications looked into users’ perceptions of data management and found “limited awareness” of the techniques by which user data was collected.59 the study identified two types of data collection: actively collected data and passively collected data. actively collected data is information that is voluntarily revealed to the service provider by the user–for example, entering what one ate that day into a diet tracking app.60 and passively collected data61 is information that is automatically revealed to the service provider and does not require active participation by the user–for example, location metadata 62 being sent to the service provider along with one’s diet entry. the study also distinguishes a subset of passively collected data called inferred data. inferred data is information that is inferred from existing data through analytic models–for example, analyzing a user’s dietary patterns to predict that this 55 jinyan zang et al. supra at note 52. 56 id. 57 jane sarasohn-kahn, here’s looking at you: how personal health information is being tracked and used 5 (2014). 58 personal data management: the user’s perspective, international institute of communications, 12 (2012) (on file with the indiana health law review). 59 see id at 14. 60 id at 12. 61 id. 62 metadata is data that describes other data. for instance, an app may store calorie counts as a series of numbers. metadata could help make sense of this raw data by labeling the numbers as “calorie counts.” 2016 397 mhealth and unregulated data: is this farewell to patient privacy? particular user will likely develop type 2 diabetes. 63 users are aware of actively collected data, because it requires their active participation; but users generally are not aware of passively collected data or inferred data because it occurs without their participation.64 b. how consumer data is used the data produced by mhealth users is stored in a number of places. some information is stored locally on the user’s mobile device, however the bulk of user data is stored on servers. these servers may belong to the company that developed the mhealth app, or, as is more often the case, to a contracted third party that offers server storage as a service. for many users, the chain of storage and data sharing should ideally end here, so that only the key service providers have access to user data. but rarely does the chain of data sharing end here. often, data is shared with or sold to a number of third parties. the primary buyers in the consumer information data market are called data brokers.65 additionally, other entities purchase consumer data for a variety of purposes. 1. use by data brokers in 2014, the ftc released a report titled “data brokers: a call for transparency and accountability.”66 the report examines the products offered by nine prominent data brokers and the types of data they collect, as well as common industry practices.67 the ftc found that these companies collect a great deal of information about consumers–one company, acxiom, reported to have “over 3000 data segments 63 personal data management: the user’s perspective, supra note 58 at 13. 64 id. at 40. 65 fed. trade comm’n, data brokers: a call for transparency and accountability, i (2014) (defining data brokers as “companies that collect consumers’ personal information and resell or share that information with others.”). 66 id. 67 id. at i. 398 indiana health law review vol. 13:2 for nearly every u.s. consumer.”68 while some of the data collected by data brokers is publicly available or seemingly benign, the ftc notes that other information is sensitive, specifically citing health data.69 the report identifies mobile devices as a new source of consumer data that “has dramatically increased the availability, variety, and volume of consumer data.”70 data that is collected is used to create descriptive profiles about consumers, and these profiles include consumers’ health information. for example, a consumer profile may include descriptive elements such as: “ailment and prescription online search propensity”, “buy disability insurance”, “geriatric supplies”, “allergy sufferer”, “tobacco usage”, “purchase history or reported interest in health topics including: allergies, arthritis, medicine preferences, cholesterol, diabetes, dieting, body shaping, alternative medicine, beauty/physical enhancement, disabilities, homeopathic remedies, organic focus, orthopedics, and senior needs”, among other information. 71 additionally, consumers are categorized more generally with labels “such as ‘expectant parent,’ ‘diabetes interest,’ [or] ‘cholesterol focus.’”72 to some degree, such labels provide benefits to consumers. on the other hand, these labels can be used in ways that are adverse to consumer interests. for instance, the report states, “while data brokers have a data category for ‘diabetes interest’ that a manufacturer of sugar-free products could use to offer product discounts, an insurance company could use that same category to classify a consumer as higher risk.”73 consumers are often unaware that data brokers even exist because data brokers do not interact directly with consumers.74 only two of the nine data brokers studied by the ftc required the data sources they contracted with to provide notice to consumers that their information will be 68 id. at 8. 69 id. at v. 70 id. at 5. 71 id. at b-6. 72 id. at 47. 73 id. at vi. 74 id. at i. 2016 399 mhealth and unregulated data: is this farewell to patient privacy? shared with third parties.75 additionally, “seven of the nine data brokers buy from or sell information to each other.”76 the findings of the ftc reiterated those of a separate report issued by the government accountability office (gao) in 2013. 77 the gao similarly identifies the collection of health data as a cause for concern and notes that “mobile devices have enabled even cheaper, faster, and more detailed data collection and sharing among resellers and privatesector companies.”78 additionally, the gao report explains that there is no federal privacy law that specifically addresses mobile applications and technologies,79 nor does federal law generally restrict the methods for data collection or the sources of collection. 80 ultimately, the statutory landscape leaves consumers with “limited legal rights to control what personal information is collected, maintained, used, and shared and how.”81 2. use by other entities new uses for data are being discovered, and while less is known about these practices, it is important to note that health data extends beyond the context of data brokers and the products they offer. on june 26, 2014, bloomberg reported that the largest hospital chains in the carolinas and pennsylvania were using consumer data to identify high-risk patients.82 the chains reportedly use this data to predict when patients might fall ill due to unhealthy habits and intervene before reaching a point that would require more costly care. similarly, a study conducted by a student at the carolina health informatics program of the university of 75 id. at 16. 76 id. at 14. 77 information resellers, supra note 7. 78 id. at 19. 79 id. at 24. 80 id. at 18. 81 id. at 17. 82 shannon pettypiece & jordan robertson, hospitals soon see donuts-to-cigarette charges for health, bloomberg tech. (june 26, 2014, 12:35 pm), http://www.bloomberg.com/news/articles/2014-0626/hospitals-soon-see-donuts-to-cigarette-charges-for-health [https:// perma.cc/zd6k-wjmg]. 400 indiana health law review vol. 13:2 north carolina at chapel hill reveals that mhealth data can be used to improve risk profiling in the insurance industry and track users’ engagement with health and wellness activities.83 while evidence of such use is scant, it is clear that providers and insurers could use mhealth data to monitor and profile patients’ behaviors. used in this manner, mhealth data could provide increased understanding of patient populations, but such use may simultaneously motivate paternalistic practices. in a system where global payments to providers are based on population health, direct intervention may be a more common interaction with patients. for instance, a patient with diabetes mellitus who is not physically active as recommended will have higher blood glucose and increased risk for infections. that patient may receive a phone call or home visit from a care coordinator to motivate them to get into an exercise program as a result. ultimately, patients may be unwilling to use mhealth tools if doing so means that their behaviors will be monitored and judged by providers and insurance companies. iv. existing policy is inadequate in the mhealth context data collection, analysis, and use have been a subject of concern for quite some time. a common reference point for policies governing data practices is the fair information practice principles (fipps).84 these guidelines were initially created by an advisory committee to the secretary of health, education, and welfare and were the basis of the privacy act of 1974,85 which governs federal agencies’ collection and use 83 dave barrett, mhealth at bcbsnc–an evaluation of the collection and usage of mobile health data through existing bcbsnc resources, unc carolina health informatics program, http://miksa2.ils.unc.edu/chip/practicum/files/posters/pdf/dave_barrett.p df [perma.cc/jkw7-sdlc]. 84 u.s. dep’t of health, educ. & welfare, dhew pub. no. (os)7394, records, computer, and the rights of citizens: report of the secretary’s advisory committee on automated personal data systems (1973), available at https://www.justice.gov/opcl/docs/rec-comrights.pdf [https://perma.cc/929m-5xjh]. 85 5 u.s.c. § 552a (1974). https://www.justice.gov/opcl/docs/rec-com-rights.pdf https://www.justice.gov/opcl/docs/rec-com-rights.pdf 2016 401 mhealth and unregulated data: is this farewell to patient privacy? of personal information. in 1980 the fipps were revised by the organisation for economic co-operation and development (oecd) and became an internationally recognized set of privacy principles. 86 the fipps are principles and while they have been used as a reference point for the creation of laws at home and abroad, they do not carry any legal authority themselves. these principles are admirable (e.g., collection limitation, data quality, purpose specification, use limitation, security safeguards, openness, individual participation, accountability87), but they are broad and do not adequately address consumer concerns regarding mhealth privacy on their own. additionally, there are a limited number of torts associated with privacy harms, and those that do exist are ill suited to address the privacy issues involved in large-scale, systematic data collection. 88 furthermore, statutory protections, implemented before the age of cloud computing, are insufficient and broadly permit third party access.89 a. the fair information practice principles were drafted before big data the fipps were created over four decades ago and rest on certain assumptions about data and its usage that must be reevaluated in a new age of computing. these principles continue to serve as meaningful guidelines, but forward thinking policies will require more nuanced considerations. 86 oecd, oecd guidelines on the protection of privacy and transborder flows of personal data (1980), available at http://www.oecd.org/internet/ieconomy/oecdguidelinesontheprotectionofp rivacyandtransborderflowsofpersonaldata.htm [http://perma.cc/p4xfpgqh]. (these guidelines were recently updated in 2013 with additional enforcement and privacy protections). 87 id. 88 president’s council of advisors on science and technology, big data and privacy: a technological perspective 6-7 (2014), available at https://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast/pc ast_big_data_and_privacy_-_may_2014.pdf [https://perma.cc/w79kpk3g]. 89 see electronic communications privacy act, 18 u.s.c. § 2702 (1986) (allowing third party access to customer communications or records with legal consent). https://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast/pcast_big_data_and_privacy_-_may_2014.pdf https://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast/pcast_big_data_and_privacy_-_may_2014.pdf 402 indiana health law review vol. 13:2 in short, “big data” has changed the game. 90 while big data encompasses much more than mhealth, it is necessary to understand the tools and economic forces of big data to see why the fipps are no longer adequate. put simply, exponential growth in computing power is continuously occurring and this growth has altered the ground rules upon which the fipps were built. 1. big data and emerging analytical techniques in january of 2014, president barack obama ordered a comprehensive review of big data technologies by counselor john podesta and the president’s council of advisers on science and technology.91 two workgroups executed this order in a 90-day, simultaneous effort, and produced insightful reports on the technologies and policy implications of big data.92 these reports (hereinafter referred to as the “big data report” and the “pcast report”) supplement one another to explain what big data is, what its benefits and pitfalls may be, and how current and future policy will be affected by big data. big data is commonly thought of as the “3 vs”: volume, variety, and velocity.93 volume refers to the sheer amount, 90 jonathan stuart ward & adam barker, undefined by data: a survey of big data definitions, arxiv.org (sept. 20, 2013, 1:51:18 pm), computer science databases available at arxiv:1309.5821, http://arxiv.org/abs/1309.5821/ [http://perma.cc/m53m-mwz2] (defining big data as “a term describing the storage and analysis of large and or complex data sets using a series of techniques including, but not limited to: nosql, mapreduce and machine learning.”) 91 transcript of president obama’s jan. 17 speech on nsa reforms, washington post (jan. 17, 2014), http://www.washingtonpost.com/ politics/full-text-of-president-obamas-jan-17-speech-on-nsa-reforms/ 2014/01/17/fa33590a-7f8c-11e3-9556-4a4bf7bcbd84_story.html/ [http://perma.cc/hkc4-vche]. 92 john podesta et al., big data: seizing opportunities, preserving values 3-4 (2014), available at https:// www.whitehouse.gov/sites/default/files/docs/big_data_privacy_report_m ay_1_2014.pdf. 93 it glossary, gartner, inc., https://www.gartner.com/it‐ glossary/big‐data/ [http://perma.cc/k8qd-6jq9] (last visited feb. 17, 2016). gartner’s it glossary defines big data as “high-volume, highvelocity and/or high–variety information assets that demand cost2016 403 mhealth and unregulated data: is this farewell to patient privacy? variety refers to the different types, and velocity refers to how quickly it is produced.94 it is “big” because the amount of data sources has grown exponentially in recent years. as stated in the big data report, “[t]he declining cost of collection, storage, and processing of data, combined with new sources of data like sensors, cameras, geospatial and other observational technologies, means that we live in a world of near-ubiquitous data collection.” 95 data can be “born digital”96 or “born analog.”97 data that is born digital is created by users or automated computer proxies for use by a computer system (e.g. entering food one has eaten into a diet tracking application, posting a review of the app, or metadata that is passively collected with a given transaction). 98 data that is born analog comes from the physical world (e.g. a photo of a wound, one’s heartbeat measured by a sensor, or the video content of a sonogram).99 all of this seemingly disparate data can be assembled and analyzed together to reveal unexpected insights about a specified group or individual, a technique known as “data fusion.”100 the results of such assembly and analysis can be useful in healthcare research. for example, one study used data taken from neonatal monitors to find early warning signs of infection that were unobservable to attending physicians. 101 similarly, the hospital systems in the carolinas and pennsylvania, mentioned above, were able to use consumers’ purchase history information to identify patients at risk of hospital effective, innovative forms of information processing for enhanced insight, decision making, and process automation.” 94 podesta et al., supra note 92, at 4. 95 id. at 4. (explaining just how big “big data is,” the report indicates that in 2013 an estimated four zetabytes were produced worldwide–a zetabyte equals 1,000,000,000,000,000,000,000 bytes, or units of information.”). 96 id. at 4. 97 id. 98 id. at 19. 99 id. at 22. 100 id. at 4. 101 ibm, smarter healthcare in canada: redefining value and success 5 (2012) available at https://www.ibm.com/smarterplanet/ global/files/ca__en_us__healthcare__ca_brochure.pdf [https://perma.cc/ zkz8-cn2f]. 404 indiana health law review vol. 13:2 admission due to unhealthy habits.102 while both of these uses of big data analytics provide a benefit, namely fighting infections in premature infants and reducing healthcare costs through early intervention, the second example poses a privacy issue that the first does not. it seems unlikely that parents would object to improved care for their infants. but are patients comfortable with the notion that insurers are monitoring their daily habits? this type of monitoring practice may lower treatment costs and assist behavioral change, but it may also do harm to patients’ perceptions of healthcare institutions and violate basic notions of privacy that people hold.103 such considerations are particularly important in the context of mhealth. users’ data can be combined and analyzed to determine a number of piercing insights. consider the variety of information that mhealth apps collect about a given user. sleep monitoring apps track sleep schedules, motion during sleep, and so-called “sleep debt”; diet tracking apps record what foods the user ate and for which meal, their calorie count, a user’s weight, and nutritional information; fitness apps record calories burned, whether a user does aerobic or anaerobic activities, and the frequency with which one exercises; alcohol tracking apps log how many drinks the user consumes, how frequently, and blood alcohol content; smoking cessation apps record the number and frequency of cigarettes consumed; pregnancy tracking apps record likely conception dates, due dates, and symptoms; mood tracking apps record emotional and psychological information; period trackers record menstruation dates, chart ovulation and fertility, and duration of menstruation and symptom searching apps record symptoms searched.104 this snapshot of mhealth apps 102 see discussion infra part iii.b.2. 103 podesta et al., supra note 92, at 79. professional practices are currently one of the few sectors that enjoy a great deal of public trust with personal data–a finding that may change as public awareness of health surveillance grows. 104 this general list of apps and the types of data they collect was compiled through a search of the ios app store and google play store. it is a small sample of the types of apps offered in mobile app markets and the information they collect. 2016 405 mhealth and unregulated data: is this farewell to patient privacy? and the information they record is far from a complete picture of what is available, but the variety of information is extraordinary. this variety, in and of itself, poses a difficult problem for the protection of individual privacy. 2. big data weakens de-identification under the hipaa privacy rule, patient data may be shared broadly so long as it is de-identified. 105 deidentification works by stripping identifying information about persons from a data set.106 the safe harbor method of the privacy rule requires the removal of eighteen specific fields of information.107 some privacy conscious companies similarly de-identify data they collect before selling or sharing that data with third parties.108 but pcast warns that de-identification as a method of protecting privacy has limited value moving forward, because re-identification methods are becoming highly sophisticated.109 in fact, the big data report states, “[c]ollective investment in the capability to fuse data is many times greater than investment in technologies that will enhance privacy.” 110 data fusion allows seemingly anonymous data to be re 105 de-identification guidance, supra note 44. 106 id. covered entities can satisfy the de-identification standards of the privacy rule by two methods: “1) a formal determination by a qualified expert; or 2) the removal of specified individual identifiers as well as absence of actual knowledge by the covered entity that the remaining information could be used alone or in combination with other information to identify the individual.” 107 id. 108 see, e.g., privacy policy, n. y. times http://www.nytimes.com/ content/help/rights/privacy/policy/privacy-policy.html#e [https:// perma.cc/w7p5-jh8g ] (last updated june 10, 2015) (discussing that they “share information about our audience in aggregate or de-identified form. nothing in this privacy policy is intended to restrict our use or sharing of aggregated or de-identified information in any way.”); see also podesta et al, supra note 92, at 8. 109 president’s council of advisors on science and technology, exec. office of the president: big data and privacy: a technological perspective 44 (2014) [hereinafter big data report] available at https://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast/pc ast_big_data_and_privacy_-_may_2014.pdf [https://perma.cc/f3rbsc5q]. 110 podesta et al., supra note 92, at 54. 406 indiana health law review vol. 13:2 identified.111 efforts to protect the privacy of users through de-identification are increasingly futile as this technique is becoming obsolete.112 additionally, prohibitions on re-identification would be difficult. it is not always obvious which data elements will identify an individual. with a large enough data set, individuals can be identified through the “mosaic effect”, whereby seemingly anonymous and unrelated data create patterns from which identifying information can be inferred. 113 while data fusion paints a seemingly bleak picture for the privacy of health information, the problem is one that can be compartmentalized. b. compartmentalizing health data re-identification poses a real problem for the privacy of health data. but solving the problem for phi is different from 111 k. el emam et al., evaluating the risk of re-identification of patients from hospital prescription records 62 canadian j. of hospital pharmacy 307, 307-319; (2009); g. loukides et al., symposium, the disclosure of diagnosis codes can breach research participants privacy, 17 j. am. med. informatics association 322-327 (2010); b. malin & l. sweeney, how (not) to protect genomic data privacy in a distributed network: using trail re-identification to evaluate and design anonymity protection systems, 37 j. of biomedical informatics, 179-192 (2004); l. sweeney, a presentation at the workshop on the hipaa privacy rule's de-identification standard, data sharing under hipaa: 12 years later, washington, dc. march 89 (2010). 112 big data report, supra note 111, at 38-39. programming languages used by those who manage data typically have commands like “join” that connect data sets based on common data points. to illustrate how easy it is to re-identify data, suppose a company has matrix a with five columns of data and matrix b with five columns of data. suppose matrix a and b overlap on one common data point. a programmer can write a command that “joins” matrix a and b based on their common data point, creating one matrix with 9 columns of data. given the sheer amount of data being produced by users and stored by data brokers, it does not take long to find a consistently unique data point to merge data sets with–like a cell phone’s imei or any other device-specific number. 113 office of mgmt. and budget, exec. office of the president: open data policy—managing information as an asset memorandum for the heads of executive departments and agencies (2013), available at https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m13-13.pdf [https://perma.cc/d73r-xku3]. http://dx.doi.org/10.1136/jamia.2009.002725 http://dx.doi.org/10.4212/cjhp.v62i4.812 http://dx.doi.org/10.1016/j.jbi.2004.04.005 2016 407 mhealth and unregulated data: is this farewell to patient privacy? solving the problem for mhealth data. when phi is deidentified, it is no longer phi and its disclosure is not restricted.114 if that data is re-identified, then it is once again phi and receives all of the legal protections originally prescribed to phi.115 on the other hand, mhealth data, as discussed above, typically does not fall under the auspices of hipaa. 116 there are no requirements to de-identify data from non-hipaa apps (though doing so is encouraged117), and it is often sold to or shared with third parties. currently the only protections afforded to users of mhealth apps not covered by hipaa are those detailed in the privacy policy of the app. privacy policies evolved from the “notice and consent” model prescribed by the fipps.118 but consumers struggle to understand privacy policies, and many do not bother reading them before agreeing to their terms.119 additionally, the technical nature of how data is collected, secured, and shared is difficult to understand as a consumer–particularly when it is embedded in the legal language of a privacy policy. even if consumers do choose to read privacy policies, doing so is not particularly enlightening. privacy policies are written primarily to cover the developing company’s legal notice requirements and not to accurately inform the consumer.120 one study came to the conclusion that, “[t]he only way for a user to know how great a privacy risk an app may be posing is by doing a technical evaluation–something beyond the ability of almost all users.”121 pcast similarly observed, “only in some fantasy 114 de-identification guidance, supra note 44. 115 id. at 9. 116 see infra part ii.b. 117 using consumer health data: some considerations for companies, fed. trade comm’n: business blog (apr. 28, 2015, 9:52 am), https://www.ftc.gov/news-events/blogs/business-blog/2015/04/usingconsumer-health-data-some-considerations-companies [https://perma.cc/ 7rxu-zyeq]. 118 u.s. dep’t of health, educ. & welfare, supra note 86, at xxvi; see also big data report, supra note 109, at 38. 119 sdl, supra note 46 (finding in a survey of more than 4,000 individuals, 65% of respondents reported that they rarely or never read privacy policies before making online purchases). 120 craig michael lie njie, supra note 48, at 20-21. 121 id at 21. the technical evaluation techniques described in this study require users to intercept the internet traffic of their mobile devices 408 indiana health law review vol. 13:2 world do users actually read these notices and understand their implications before clicking to indicate their consent.” 122 under the “notice and consent” model, the consumer is incapable of modifying the privacy policy and is left with a binary choice: agree to the terms or stop participating in digital society. a new system is needed to restore meaningful choices to consumers. v. removing uncertainty will provide meaningful choices in the mhealth market congress deemed health information uniquely private and worth protecting when it passed hipaa’s stringent privacy and security rules. one would expect that user generated data should receive the same protections, but such data presents a unique problem. as noted in the big data report, “[t]he powerful connection between lifestyle and health outcomes means the distinction between personal data and health care data has begun to blur.”123 data one may never think of as health information can be extrapolated and cross-referenced to produce deep insights into an individual’s health. for instance, by cross-referencing purchasing information with additionally purchased consumer data, target was able to identify customers who were in their second trimester of pregnancy. 124 however mhealth applications are uniquely revealing. such apps produce detailed logs of a user’s health information, and do not require costly or difficult analysis. while it is true that data fusion allows some health information to be inferred, inferred data does not provide the level of detail and granularity that mhealth apps effortlessly expose. in particular, devices that measure biometric information through sensors provide data that cannot be inferred to the same level of accuracy. if the unfettered trade of detailed by connecting a “man-in-the-middle, ssl-enabled proxy server”, and decoding their internet traffic through a series of software tools that go far beyond the average user’s understanding of computers. id. at 11. 122 big data report, supra note 109, at xi. 123 id. at 23. 124 charles duhigg, how companies learn your secrets, n. y. times magazine (feb. 16, 2012), http://www.nytimes.com/2012/02/19/ magazine/shopping-habits.html?_r=0 [http://perma.cc/lgg3-ngat]. 2016 409 mhealth and unregulated data: is this farewell to patient privacy? biometric and behavioral data is allowed, hipaa’s privacy protections will become obsolete. additional government intervention is needed, but given the inherent problem in defining or regulating “health data” the government cannot realistically ban the sale of health data. instead, congress should create a simple labeling system. in particular, there is a need for two labels: (1) a label that reads “hipaa compliant”, and (2) a label that reads “confidential.” apps marked hipaa compliant would be just that, compliant with the regulations of hipaa and suitable for use by covered entities and their business associates. 125 apps marked confidential would guarantee that user data is not sold to or shared with third parties. apps with no label will continue under the current notice and consent regulatory scheme. a. “confidential” label provides a meaningful consumer choice the current notice and consent framework of the fipps does not provide consumers with meaningful choices. rather, an unregulated data market incentivizes companies to pursue a single business model: collect and sell as much data as possible.126 as a result, there is little incentive to provide consumers with tools to restrict data collection. industry representatives argue that ubiquitous collection actually provides a benefit to consumers, because the data market subsidizes the true cost of software and provides consumers with free services.127 the premise of this argument is that personal data is a commodity and consumers are trading this commodity in exchange for digital services. if one accepts 125 letter from tom marino & peter defazio, members of congress, (sept. 18, 2014), available at http://actonline.org/wp-content/uploads/ 2014/09/letter-to-secretary-burwell-september-18-2014.pdf [http:// perma.cc/kn7r-9bc6] (representatives marino and defazio have already suggested a “voluntary badge program” to indicate hipaa compliance). 126 big data report, supra note 111, at 54 (referring to this phenomena as a “digital land grab” that has resulted in “structural overcollection”). 127 gov’t accountability office, supra note 7, at 40. 410 indiana health law review vol. 13:2 that personal data is a commodity, then the currencies of the data market become clear. consumers that wish to have their personal data kept from third parties will have to pay the full cost of the software. many consumers already believe that if they pay for the software they are using, then only the service provider will use their data,128 but there is no guarantee that this is the case. in fact, paid mhealth apps have been found to collect and share data only marginally less than free apps. 129 the “confidential” label would unambiguously provide that guarantee. the current "notice and consent" system relies on contractual agreements. consumers are responsible for reading, and accepting or denying, the terms of each service contract. the confidential label is meant to simplify the most important privacy component of the contractual agreement data sharing with third parties. it is intended to bind companies to certain terms. the essential terms of the confidential label are: (1) products with confidentiality labels cannot sell or share consumer data with third parties; (2) products with confidentiality labels cannot revoke the label once it has been adopted;130 (3) if a company offering products with a confidential label goes bankrupt or is sold to a third party, it can only transmit consumer data to the new parent company and cannot sell data to additional third parties.131 the confidential label would serve as a condensed privacy policy that is actually intelligible, with terms enshrined in law and not up to the whims of changing contracts. creating such a label would standardize the terms of data use in the user and service provider relationship. consumers interested in keeping their mhealth data from third parties would not have to wade through extensive privacy policies, 128 international institute of communications, supra note 58, at 12. 129 craig michael lie njie, supra note 48, at 15. 130 this term aims at preventing mid-service changes in privacy policies, so that a service provider cannot simply reorder the terms of their agreement and have users unwittingly agree to retroactive third party access to data. 131 natasha singer & jeremy b. merrill, when a company is put up for sale, in many cases, your personal data is, too, n. y. times, http://www.nytimes.com/2015/06/29/technology/when-a-company-goesup-for-sale-in-many-cases-so-does-your-personal-data.html. 2016 411 mhealth and unregulated data: is this farewell to patient privacy? but instead could look for a product that is marked confidential. for privacy conscious consumers, this label would provide a meaningful choice in a marketplace where currently the only choice is to broadcast health data or live without mhealth tools. b. voluntary labeling these labels should be adopted voluntarily by companies rather than mandated. it is unrealistic, and unwieldy to have an agency determine each and every app that needs to be labeled hipaa compliant or confidential before the app goes to market. there are more than 100,000 apps in the mhealth market,132 but only a fraction of this total enjoys a wide user base. diverting agency resources to regulate unused or underused apps does not address the heart of the problem. mandating that mhealth developers not sell or share data would likely require most companies to restructure code– because data sharing is often automated–contracts, and business models. a number of stakeholders have voiced concerns to congress and federal agencies that costly economic impact will accompany mandatory regulatory compliance. 133 allowing voluntary adoption rather than mandating increased privacy protections would still allow companies to provide free options to consumers while providing privacy conscious consumers with a meaningful choice. this would increase the range of products available to the consumer. furthermore, voluntary adoption allows companies to decide whether their company is compliant with the label’s standards before labeling their product. adopting a hipaa compliant label would not result in any increased regulatory burden to developers–those who are subject to hipaa must be compliant whether they are labeled or not. the benefit of the label is that it would clarify product availability for covered entities and business associates. adopting a confidential label, however, would result in an increased regulatory burden, because the 132 infra part i; jen miller, the future of mhealth goes well beyond fitness apps, cio, (dec. 4, 2014 4:09 am pt) http:// www.cio.com/article/2855047/healthcare/the-future-of-mhealth-goeswell-beyond-fitness-apps.html [http://perma.cc/ka3c-2z2e]. 133 see information resellers, supra note 7, at 29-30, 33, 37, 42-43. 412 indiana health law review vol. 13:2 developer would voluntarily revoke the right to sell consumer data. the benefit of doing so rests on the assumption that consumers value their privacy enough to pay a higher cost upfront to offset developers’ loss in revenue from data sales. personal data has been estimated to be worth as little as $0.0005 per person for general information, such as age, gender, and location, to $0.26 per person for medical information, such as listed conditions like arthritis, high blood pressure, and diabetes.134 developers could calculate the estimated value of the data they collect and charge this cost upfront. it is conceivable that the first confidential products could be marketed for the highest price, while competition would, over time, drive down prices to the benefit of consumers. c. labels create legally enforceable standards these labels could be achieved by amending two existing pieces of legislation. the hipaa compliance label could be added to the hipaa privacy rule, and the confidentiality label could be added to the federal trade commission act (ftc act). 135 the department of health and human services enforces hipaa through the office for civil rights, while the ftc has carried out enforcement actions against non-hipaa mhealth developers for unfair or deceptive practices related to privacy policies.136 similarly, the ftc 134 emily steel et al., how much is your personal data worth?, financial times, (jun. 13, 2013, 8:11 pm), http://www.ft.com/ cms/s/2/927ca86e-d29b-11e2-88ed-00144feab7de.html [http://perma.cc/ 4gc5-2vqg] (select “family & health” tab). 135 the hipaa privacy rule is codified at 45 cfr parts 160 and 164, subparts a and e; the ftc act can be found at 15 u.s.c. §§ 41-58 (2016). 136 u.s. dep’t of health and human services, hipaa enforcement, available at http://www.hhs.gov/hipaa/for-professionals/ compliance-enforcement/; payments md, llc, no. c-4505, f.t.c. (jan. 27, 2015); payments md, llc, no. c-4505. 2015 ftc lexis 24 (f.t.c., jan. 27, 2015); gmr transcription services, inc., no. c-4482, f.t.c. (aug. 14, 2014); gmr transcription services, inc., no. c-4482, 2014 ftc lexis 199 (f.t.c., aug. 14, 2014); accretive health inc., no. c4432, (feb. 5, 2014); accretive health inc., no. c4432, 2014 ftc lexis 30 (f.t.c., feb. 14, 2014). 2016 413 mhealth and unregulated data: is this farewell to patient privacy? has hosted industry workshops that urge mhealth companies to protect user data,137 and is the agency charged with consumer protection. 1. enforcement enforcement mechanisms are already part of hipaa and the ftc act.138 the health and human services’ office of civil rights (ocr) is charged with enforcement of the privacy rule.139 in the ftc act, the ftc is charged with enforcement of consumer protection.140 by piggybacking off of these existing resources and procedures, the labels could be created and enforced at a relatively low cost. 2. compliance companies that choose to adopt a confidential or hipaa compliant label would be responsible for assessing the company’s ability to comply. once a company adopts a label, the ocr and ftc should monitor company actions and receive patient and consumer complaints reporting misuse of data. 3. exceptions in order for the confidentiality label to be technically feasible, a few exceptions to the ban on sharing data would be necessary. mhealth developers must be able to contract for server storage and cloud services. additionally, mhealth developers must be able to analyze user data in order to improve technical performance and offer new services to their customers. it is common to have third parties perform such analysis and provide developers with relevant findings. 137 see spring privacy series: consumer generated and controlled health data, fed. trade comm’n, https://www.ftc.gov/newsevents/events-calendar/2014/05/spring-privacy-series-consumergenerated-controlled-health-data [http://perma.cc/uvx2-zu74]. 138 the hipaa enforcement rule is codified at 45 cfr part 160, subparts c, d, and e; the ftc act can be found at 15 u.s.c. §§ 41-58 (2016). 139 u.s. dep’t of health and human services, supra note 136. 140 the ftc’s enforcement powers are granted in 15 u.s.c. § 57b (2016). 414 indiana health law review vol. 13:2 much like the “business associates” referred to in hipaa, which are granted certain access rights to phi, the business associates of mhealth developers should be granted the ability to access and analyze user data. vi. conclusion while the fda has taken a meaningful first step in regulating mobile medical devices through the fd&c act, apps not currently covered by hipaa are producing volumes of patient data. this user-generated data is being commoditized and sold, and consumers are often unaware of the ramifications. this problem is significant, as data produced by mhealth users can be even more revealing than the person’s medical record. a voluntary labeling system should be put in place that would provide meaningful choices for consumers and protect their data. by focusing on hipaa compliance and standardizing data confidentiality, this labeling system could demystify much of the confusion and ignorance that currently exists for companies and consumers alike. the time has come to address the unregulated data market that silently exists in the u.s. today. in memoriam of eleanor dearman kinney – professor of law william h. thompson, esq.* i am honored to submit this essay in memory of eleanor kinney. what better soul to celebrate than that of professor kinney! professor kinney helped educate and mentor two generations of indiana healthcare lawyers. i had the good fortune of being one of those lawyers. i have to start with how i first met professor kinney. in the early 1980s, i had just finished my master of science in health administration and accepted a position at indiana university hospital. prior to that, i had worked for three years at wishard hospital (now eskenazi health) in several lower-level administrative roles. it was at indiana university hospital that i first contemplated going to law school. john render, then chair of hall render, had taught the health law class in my mha program—john inspired me to go beyond health administration and pursue health law. so, with the help of dean frandsen, i was admitted to the evening program of the indiana university robert h. mckinney school of law in 1983. upon arrival, i was disappointed as to the lack of classes that had much to do with health law. there was law and medicine, taught by professor larry wilkins, a torts class, and not much else. of course, at that time health law was just coming into its own as a recognized sector of the law. enter professor kinney in 1986. wow, what a force! i was immediately impressed with eleanor’s real-world experience. she had worked at the department of health and human services and as a deputy general counsel at the american hospital association—she was a true health lawyer! i gravitated immediately to eleanor as someone i knew could help me pursue a career in health law. eleanor was incredibly receptive to my advances and my neverending questions and eagerness to find classes to help me become a health lawyer. eleanor was always so gracious and genuine. she and her husband, charlie, would invite me to receptions at their beautiful home where out-of-town health law scholars would come to discuss important issues in health law. the conversations were always enlightening. no other professor had extended such an invitation to me, but that was eleanor—no pretense, and always a willingness to include students and to encourage them to learn. when i finished law school in 1987, eleanor was instrumental in helping me obtain an associate position at hall render—hall render is where i wanted to be from the very beginning. eleanor had become a colleague and good friend of bill hall and john render and pointed me in the direction of their firm, for which i am eternally grateful. as an aside, eleanor and bill hall had a special relationship. they were at the opposite ends of the political spectrum, but greatly respected each other’s views. they both believed that access to high quality and affordable healthcare was a basic human right. i had the opportunity to sit in on a number of discussions between bill and eleanor, on far-ranging topics of health policy and law, from the clinton health plan and medicare policy, to the * chair, hall, render, killian, heath & lyman, pc 6 indiana health law review [vol. 17:5 differences in the delivery systems of latin american countries. i never failed to learn something from those discussions, much of which remains relevant in my practice today. in 1986, bill hall and his wife, christine, made a generous contribution to mckinney’s center of law and health. the center was renamed as the “william s. and christine s. hall center for law and health” in recognition of bill and his wife’s remarkable contribution. professor kinney was named the center’s first director. the hall center flourished under eleanor’s guiding hand, and it continues to flourish today under professor terry’s leadership. all of us at hall render are incredibly proud of what the center has accomplished, from its expansive health law curriculum, to its joint degree programs, and to its incredible research on the opioid crisis. the health law program has been recognized as one of the top ten programs in the country, thanks to eleanor’s vision and the strong support of the health law professors and leadership of the indiana university mckinney school of law. the center will forever rest on the spirit of professor kinney. she was truly one of a kind! rest in peace eleanor. disclosure of gamete donation in the united states disclosure of gamete donation in the united states maya sabatello, llb, phd* i. historical background.... ....................... 32 ii. truth-telling...................................42 iii. identity formation.............................56 iv. the genetic tie.................................61 v. medical data....................................65 vi. conclusion ..................................... 78 this article explores whether the united states should follow the international trend in reversing the policy of gamete donors' anonymity. briefing the history of the practice of gamete donation, i scrutinize the four core arguments raised by disclosure proponents: the harmful effect of secrecy in the construction of family relations; the relevance of genetic information for one's identity formation; the significance of one's genetic origin to kinship; and the importance of retrieving one' genetic origin for medical reasons. i suggest that these arguments are not universal facts but mostly a matter of cultural construction of child welfare and 'hest interests, "and that they are unfounded in existing studies based in the united states. the arguments further do not properly consider the interests of all stakeholders, including those of donor-inseminated children, nor stand the test of america's multicultural fabric, preference for non -interventionist governance, and predilection for a free market. the appropriateness of the emerging 'hild's right to know" and the broader implications of such a right are also considered. the article nonetheless suggests that regulating the work of fertility clinics is justified to overcome shortcomings in medical practice in the united states, especially given its unique healthcare system. indiana health law review over the past twenty years, the once unassailable policy of preserving gamete donors' anonymity has been intensely challenged. sweden led the way in removing sperm donors' anonymity in 1985. since then, switzerland; germany; the netherlands; new zealand; the australian states of victoria, western australia, and new south wales; iceland; and the united kingdom have all followed suit. while some differences in the laws of these countries exist, the gist of such disclosure laws is that gamete donors are now required to provide their identifying information and to consent for the release of this information to any resulting donorconceived child, who, upon reaching maturity, may request it and approach the donor. thus, notwithstanding the still prevalent policy of donor anonymity in many countries in the world, the trend towards disclosure of gamete donors' identifying information is visible. demands for the disclosure of gamete donors' identity are commonly grounded in the terminology of children's rights, especially the concepts of child welfare and "best interests" that are enshrined in the convention on the rights of the child ("crc").' in the context of gamete donation, disclosure proponents underscore four main arguments: (1) the harmful effect of secrecy and preference for truth-telling in the construction of family relations; (2) the relevance of genetic information for one's identity formation; (3) the significance of one's genetic origin to kinship; and (4) the importance of genetic information for medical purposes. subsequently, some critics have * postdoctoral research fellow at columbia university's center on research of ethical, legal and social implications of psychiatric, neurologic and behavioral genetics; adjunct assistant professor at nyu's center for global affairs. llb, 1998, hebrew university of jerusalem; phd in political science, 2006, usc; research fellow in medical ethics, 2011-2013, harvard medical school; visiting research fellow, 2012-2013, columbia university law school. previous versions and parts of this article were presented at columbia university's human rights seminar (2011), harvard's medical ethics retreat (2012), and the hastings center (2013), and i want to thank the participants for their useful comments. 1 convention on the rights of the child, ratified nov. 20, 1989, 1577 u.n.t.s. 3 (entered into force sept 2, 1990) [hereinafter crc]. vol. 11-130 disclosure of gamete donation blatantly accused non-disclosing parents of neglecting their child's best interest by selfishly putting their own rights to privacy and reproductive freedom ahead of their child's rights.2 disclosure proponents further suggest that a child's inherent and universal two-tiered 'right to know' is recognized: a right to know about the circumstances of one's conception, and a right to know information about the donor.3 increasingly, calls to adopt a disclosure policy are also being heard in the united states. this is the case despite the fact that assisted reproductive technologies ("arts") are hardly regulated in the united states, nor is the country a party to the crc. nevertheless, disclosure advocates justify their stance on the principles of child's welfare, best interests, and rights, all of which are well enshrined within the american legal system. while recognizing that such a change may negatively affect the number of donors, proponents argue that, "the child's right to know" prevails.4 as the debate continues and more nations adopt policies that allow for disclosure of donor information to recipient parents and children, it is important to take a closer look at the relevance of this debate to the united states. this essay explores whether the rationales that are raised in favor of disclosure stand in the united states. after a brief history of the practice of gamete donation, i scrutinize the four core arguments raised by disclosure proponents. i argue that the implied universality of the rationales in favor of disclosure does not hold. with the exception of the point about medical data, i suggest that these arguments are matters of cultural construction rather 2 olga van den akker, a review of family donor constructs: current research and future directions, 12 human reprod. update 91, 96 (2006). 3 lucy frith, beneath the rhetoric: the role of rights in the practice of non-anonymous gamete donation, 15 bioethics 473, 47484 (2001) [hereinafter frith, beneath the rhetoric]. 4 lucy frith, gamete donation and anonymity: the ethical and legal debate, 16 hum. reprod. 818, 818-24 (2001) [hereinafter frith, gamete donation]; mikki morrissette, behind closed doors: moving beyond secrecy and shame (the donor sibling registry, ed., 2006). 2014 31 indiana health law review than universal facts. the arguments may not stand the test of america's multicultural fabric, its preference for noninterventionist governance, and its predilection for a free market--characteristics that set the united states apart from european and scandinavian countries. moreover, i suggest that-despite the claims of child-centerednessdisclosure does not always correspond with children's best interests. caution is needed as these arguments have been insufficiently documented in existing studies, particularly those based in the united states, and do not necessarily represent the authentic voices of donor-conceived children. the emergence of the so-called "child's right to know" should also be scrutinized; it raises profound questions about what sort of information all children, both donor and naturally conceived, have "a right to know" and what society's obligations are in ensuring that this right is exercisable-an issue that is especially challenging in light of the united states' creeds. the argument about medical data, in contrast, has particular relevance in the united states. while this argument certainly has its own complexities, i highlight shortcomings in medical practice in the united states that are particularly harmful to the interests of donor-conceived children. subsequently, i suggest that while secrecy among family members should remain in the realm of privacy, the interests of donor-conceived children as well as of other stakeholders can be answered by regulating fertility clinics so that they are legally required to obtain and preserve identifying information about the donor and make nonidentifying medical data available to recipient parents and to donor-conceived children at least when the latter experiences a medical condition that may be traced back to the donor. the final section summarizes the conclusions and pinpoints the need for future research. i. historical background the practice of gamete donation for humans has seen dramatic changes in the past century. three interrelated points are particularly salient. the first is the shift from 32 vol. 11:1 disclosure of gamete donation being an esoteric practice to one that is significantly more common than had been previously imagined. historically, the practice of gamete donation was primarily used in married couples where the husband experienced infertility, and sperm donation was used to overcome this condition. the development of in vitro fertilization ("ivf") in 1978, however, gave the practice of gamete donation a significant boost. in this process, the woman's egg is fertilized outside the woman's body and then implanted in the womb. thus, in addition to traditional sperm donation, the practice of ivf later made possible also egg donation and embryo donation. subsequently, towards the end of the twentieth century, gamete donation has increasingly been used not only to assist infertile husbands, but also to achieve pregnancy in couples where the wife or both husband and wife experience infertility.5 furthermore, untraditional families, especially single mothers and same-sex couples, particularly lesbian couples, have become important consumers in this market. 6 indeed, through art, both members of a lesbian couple can now be biologically linked to the child: one partner provides the egg, i.e. the genetic mother, while the other serves as the gestating mother. shifts in societal attitudes towards greater acceptance of the practice of gamete donation were further critical in this development. the highly vocal moral and religious opposition to the practice of gamete donation,7 which historically occupied much of the discourse, started to dwindle in the 1960s. infertility has increasingly been 5 over three million children have been born worldwide as a result of art, with a rate of over 200,000 a year. judith f. daar, accessing reproductive technologies: invisible barriers, indelible harms, 23 berkeley j. gender l. & just. 18, 29-30 (2008). 6 id., at 32-33; see also julie shapiro, a lesbian centered critique of "genetic parenthood" 9 j. gender race & just. 591, 608 (2005). 7 see, e.g., joseph g. schenker, legitimising surrogacy in israel: religious perspectives, in surrogate motherhood: international perspectives 243, 257-58 (rachel cook et al. eds., 2003); mahdi zahraa & shaniza shafie, an islamic perspective on ivf and pgd, with particular reference to zain hashmi and other similar cases, 20 arab l. q., 152, 162-63 (2006). 2014 33 indiana health law review recognized as a medical condition that can be treated and overcome.8 additionally, greater acceptance of untraditional family structures, as well as the rise in concepts of children's rights, led to the ending of the legal entanglement between gamete donation and religious opposition to the practice. thus, while during the first half of the twentieth century courts in the united states and elsewhere viewed gamete donation as adultery and held donor-conceived children as illegitimate, in 1964, georgia became the first state in the united states to pass a statute legitimating donor-conceived children if both husband and wife consented in writing to the donor insemination.9 starting in the 1970s, many other states in the united states and countries around the world adopted similar laws, legalizing sperm donation and treating the husband, and not the sperm donor, as the natural father of the donorconceived child.10 finally, the standards of medical ethics as required in the context of gamete donation have changed. because the practice of gamete donation was historically either condemned or stigmatized, it was performed in secrecy. donors were recruited through personal contacts and were assured anonymity and confidentiality; their records were 8 today, it is estimated that art technologies provide an answer for approximately 95% of infertility cases. see miryam z.wahrman, fruit of the womb: artificial reproductive technologies & jewish law, 9 j. gender race & just. 109, 128 (2005). 9 sonia fader, sperm banking history,, cal. cryobank, http://www.cryobank.com/learning-center/sperm-banking-101/spermbanking-history/ (last visited oct. 27, 2013). 10 see, e.g., 1973 unif. parentage act (amended 2002). the 1973 act was adopted by nineteen states; it was revised in 2000 and once again in 2002 to respond to the technological changes relevant to families, including dna testing and art. only six states adopted the 2000 act, and importantly, it has been criticized for not being responsive to same-sex couples who resort to art. see generally mary p. byrn, from right to wrong. a critique of the 2000 uniform parentage act, 16 ucla women's l.j. 163 (2007). for the united kingdom, see the human fertilisation and embryology act, 1990, c. 37, available at http://www.legislation.gov.uk/ukpgal 1990/37/contents (last visited oct. 27, 2013). the act was revised in 2008. see also elliot n. dorff, matters of life and death: a jewish approach to modern medical ethics 352 (2003). vol. 11:134 disclosure of gamete donation often not kept at all or destroyed after a time period of a few years. recipient parents were recommended to keep it a secret, including from the donor-conceived child. the first reported instance of sperm donation at the jefferson medical college in philadelphia in 1884 is an example. in that case, the physician inseminated the wife of his patient with sperm from one of his students without informing the couple about the procedure. only once the pregnancy was achieved did the physician confide the secret to the husband, who, according to the report, was nonetheless delighted to hold the child as his own.11 today, the regulatory environment surrounding gamete donation is markedly different. although the privacy interests and rights of gamete donors and recipient parents are recognized and gamete donors are legally absolved from any parental responsibility, the informed consent of both donors and recipient parents is required for this medical procedure. while countries differ in their regulations of art, there is a general consensus, especially among western countries, that carrying out an art service without such consent exposes an art service provider to civil tort suits, and possibly also to criminal charges. 12 in countries where gamete donation is allowed,13 recruitment 11 fader, supra note 9. 12 criminal liability arises in cases of battery, referring to harmful touching, including medical treatment, without the consent of the individual at stake or when the consent was obtained as a result of a lie or fraud. 13 some countries explicitly prohibit gamete donation, e.g. italy and austria. in november 2011, the grand chamber of the european court of human rights upheld the austrian law banning egg and sperm donation other than of the spouse. according to the law, egg donation is under all circumstances prohibited, and perm donation is only possible when the sperm is directly placed in the womb of a woman, i.e. in vivo artificial insemination. the grand chamber ruled that although there is an increasing trend among member states towards allowing gamete donation, no clear common ground has been established as yet and that given the moral and ethical dilemmas arising from this practice, austria must be given a wide margin of appreciation as to how to regulate this area. see s.h. v. austria [gc], no. 57813/00, echr, nov. 17, 2011, available at http://hudoc.echr.coe.int/sites/eng/pages/search.aspx?i=001107325. 2014 35 indiana health law review of gamete donors is often carried out in public spaces-from fertility clinics, to campuses, to on-line services. moreover, in the united states-in contrast to most other countriesthe practice itself is viewed as part of a thriving economic market, where gamete donors are financially compensated.14 some fertility clinics recruit egg donors by offering them lucrative sums of money per donation: whereas the average donor receives between $5,000$10,000; there are reports of egg donors receiving up to $50,000 per donation.15 although the financial compensation for sperm donors is significantly lower,' 6 men often donate multiple times in multiple fertility clinics, making it a profitable practice for them as well. the current call to reverse the policy of gamete donors' anonymity and to recognize the child's two-tiered "right to know" are grounded in those historical shifts surrounding art practices including gamete donation. as these practices became more prevalent, some recipient parents, and, in some instances donor-conceived children, have demanded to receive more information about their donors. and while some are satisfied with non-identifying information about the donor, such as personal background and general medical data, others suggest nothing short of full identifying information so as to allow the donorconceived child to meet the donor in the future. it is this latter approach that reflects the current challenge. although the vast majority of countries in the world still retain the policy of anonymity-in israel and france, for 14 in the united kingdom, israel, and france, for instance, gamete donation has to be altruistic. financial compensation of gamete donors is limited to expenses and inconveniences directly associated with the donation. in france, donors are only reimbursed of travel expenses. a review of the hfea's sperm and egg donation policies 2011, human fertilisation and embryology auth. 8, 10, (2011), http://www.hfea.gov.uk/docs/2011-01-13_donationreview-background. pdf. 15 usha rengachary smerdon, crossing bodies, crossing borders international surrogacy between the united states and india, 39 cumb. l. rev. 15, 32 (2008). 16 id. ("donor sperm typically costs $300 on average with "top end" sperm going for $2,950."). 36 vol. 11:1 disclosure of gamete donation instance, it is also explicit in law-demands for full disclosure are being made beyond the individual request and as a matter of public policy. reiterating the aforementioned four arguable harms, disclosure proponents ground their claims in the notions of children's rights. they commonly reference child welfare and the "best interests" stipulated in the crc, as well as to the crc stipulated child's rights "as far as possible, to know and be cared for by his or her parents" and "to preserve his or her identity."17 others suggest that in genetic-related dilemmas, the principle of "the child's right to an open future" should be applied. that is, they propose that children have some "rights-in-trust" that require adult protection so that the child can exercise those rights upon becoming an adult, and that the policies adopted should aim at maximizing the child's possible life choices.' 8 in response, an increasing number of countriesparticularly those in europe and, especially, scandinaviahave reversed the policy of anonymity and required that information about the gamete donors be recorded and, upon request, made available to the donor-conceived child.' 9 for the most part, these disclosure laws establish "passive registries."20 they record some identifying information about the genetic parent, and the expectation is that the donor-conceived child, upon reaching the required age, usually between sixteen and eighteen, be the one to initiate the release of the identifying information. thus, for instance, in sweden, the 1985 law2 1 grants a donor17 crc, supra note 1, at pt. 1, arts. 3 1, pt. 1, art. 7-8. 18 dena s. davis, genetic dilemmas: reproductive technologies, parental choices, and children's future 22-34 (2001). 19 recipient parents can receive some non-identifying information about the donor such as ethnicity, education, age, etc. as part of the art treatment. 20 i. glenn cohen, response: rethinking sperm -donor anonymity: of changed selves, non -identity, and one-night stands, 100 geo. l.j. 431, 445-47 (2012) [hereinafter cohen, rethinking sperm-donor anonymity]. 21 5-6 ch. lag om genetisk integritet [the genetic integrity act], (svensk fbrfattningssamling [sfs] 2006:351) (swed.), available at http://www.smer.se/news/the-genetic-integrity-act-2006351/. 2014 37 indiana health law review conceived child the right to receive information about the donor's physical attributes, profession, and identifying data. although the exact age for requesting access to the donor's information is not specified, the law stipulates that the child should be "sufficiently mature," which has been interpreted to mean "upper teens," and after the child's maturity was evaluated by an expert either at the social welfare agency or at the hospital.22 in new zealand, the human assisted reproductive technology ("hart") act became law in 2004.23 as of august 2005, it set up a comprehensive regime whereby information about donors, donor-conceived children, recipient parents and siblings of donor-conceived children is recorded and maintained via a national register that is organized and monitored through the department of internal affairs. donors' information includes physical attributes, ethnicity, family background and cultural affiliation, and they are required to make themselves available for contact by the donor-conceived child.24 similarly, the 2002 law in the netherlands25 creates a comprehensive central register, controlled by an independent national foundation for donor data ("fdd") created by the government, to regulate art and the possibilities for donor-conceived children to access information about their donors.26 it allows recipient 22 maturity is obtained in sweden at eighteen. claes gottlieb et al., disclosure of donor insemination to the child:' the impact of swedish legislation on couples'attitudes, 15 hum. reprod. 2052, 2052 (2000). 23 human assisted reproductive technology act 2004 (n.z.), available athttp://www.legislation.govt.nz/act/public/2004/0092/latest/ whole.html#dlm319306. 24 m. legge et al., a retrospective study of new zealand case law involving assisted reproduction technology and the social recognition of new'family, 22 hum. reprod. 17, 23 (2007). 25 act containing rules relating to the use of gamete and embryos [the embryos act], stb. 2002, 338 (neth.), available at http://www.minvws.n1/includes/dllopenbestand.asp?file=/images/engem bryowettekst_tcm20-107819.pdf. 26 p.m.w. janssens et al., a new dutch law regulating provision of identifying information of donors to offspring: background, content and impact, hum. 21 reprod. 852, 853 (2006). vol. 11:138 disclosure of gamete donation parents and donor-conceived children at or above age twelve to request access to non-identifying medical information about the donor. a donor-conceived child at or above age sixteen may also request the fdd to access identifying information about the donor. upon receiving such a request, the fdd contacts the donor and asks permission to transfer identifying information. if, however, the donor objects, it is up to the fdd (and possibly the courts) to evaluate the donor's objections; unless there are strong counter-arguments, the request of the donor-conceived child will prevail. in the united kingdom, gamete donors' anonymity has been abolished since 2005. when a donor-conceived child reaches age eighteen, he or she can request the human fertilisation and embryology authority to receive information about the donor, including physical appearance, race, familial history (for instance, whether the donor was adopted or whether he or she has other children), and medical history as well as religion, occupation, interests and skills, and why the donor provided the gamete. gamete donors are required to consent to provide their identifying information to any potential donor-conceived children at the age of legal maturity, i.e. eighteen years old.2 7 the new assisted reproductive treatment act ("arta") of 2008 in victoria, australia, takes this a step further. while previous law had already established a central register to record identifying and non-identifying information about gamete donors and offspring, the new act makes it mandatory to provide identifying information to all donor-conceived children, upon request, at age eighteen. donor-conceived children may also request such information prior to eighteen, and without the consent of the parent or guardian, so long as a counselor has found the donorconceived child to be sufficiently mature to understand the 27 the human fertilisation and embryology authority (disclosure of donor information) regulations 2004, 2004, s.i. 2004/1511 (u.k.), available at http://www.legislation.gov.uk/uksi/2004/1511/pdfs/ uksi_20041511_en.pdf. 2014 39 indiana health law review consequences of the information.28 moreover, birth certificates of donor-conceived children born after january 1, 2010, have an addendum attached stating the circumstances of the child's conception and the availability of information about his or her genetic origin.29 there are currently further calls to extend this law retrospectively. 3 0 in light of these developments, the united states presents an interesting case study to explore. unlike most of these other countries, 31 the united states lacks any comprehensive federal regulations that require fertility clinics to record information about the donors. the food and drug administration ("fda") standards are limited to health-related concerns about the gamete. while the fda require a summary of records for semen donations and screening of donated gametes for an array of inherited and infectious diseases and conditions, there are no further obligations to keep the donor's records indefinitely or to make them available for the donor-conceived child.32 and while the american society of reproductive medicine has issued recommendations to the effect that donors' 28 assisted reproductive treatment act 2008 (vic) pt vi, s.56-61 (austl.); rachel thorpe et al., in the best interests of the child? regulating assisted reproductive technologies and the well-being of offspring in three australian states, 26 int'l j. law pol'y family 259, 262 (2012); see also law reform committee, inquiry into access by donor-conceived people to information about donors, at 19-20 (2012), available at http://www.parliament.vic.gov.aulimages/stories/ committees/lawrefromliadcpiad/dcpfinalreport.pdf. 29 assisted reproductive treatment act 2008 (vic) s 153 (austl.). 30 guido pennings, how to ill gamete donation: retrospective legislation and donor anonymity, 27 hum. reprod. 2881, 2881-85 (2012). 31 an exception is australia where the issue is regulated on state rather than federal level. 32 china r. rosas, a necessary compromise: recognizing the rights of a donated generation to tame the wild wild west of california's sperm banking industry, 37 sw. u. l. rev. 393, 402-03 (2008); vanessa l. pi, regulating sperm donation: why requiring exposed donation is not the answer, 16 duke j. gender l. & pol'y 379, 382 (2009). the fda requires fertility clinics to preserve donated gamete for a period of six months and to retest them before they can be used in order to screen for infectious diseases such as hiv. 40 vol. 11:1 disclosure of gamete donation information should be recorded and kept indefinitely, the organization's lack of legal teeth means that, ultimately, it is in the hands of the individual states to determine how to regulate the activities of private fertility clinics and gamete banks working in their region and how, if at all, to preserve gamete donors information. consequently, although most states regulate the issue of legal parenthood when gamete donation is involved and absolve the donor from parental responsibility, less than half have regulated the operations of sperm banks, and there is inconsistency as to how, whether, and under what conditions, donors' information is obtained, is checked, and can be released. 33 there are also differences in the extent of information provided about sperm and egg donors-the latter commonly requiring more 34-and in price: fertility clinics charge higher rates for non-anonymous donors. 35 in contrast, in july 2011, washington became the first and only state in the united states to adopt a law requiring that gamete donors provide a medical history and identifying information to fertility clinics.36 while this law does not go as far as the law in the united kingdom or other scandinavian countries, it allows donor-conceived-children to access this information once they reach the age of eighteen, with the proviso that the donor can veto the provision of identifying information. should other states in the united states be required to follow suit and regulate gamete donation in the european and scandinavian spirit? in the next sections i consider the four core arguments of disclosure proponents and consider their application given american social and legal characteristics and creeds. 33 pi, supra note 32, at 384-86; rosas, supra note 32, at 404-06. 34 the reason to the difference in information provided about sperm and egg donors may be rooted in the fact that there are more medical practices that can be performed on egg donors and given the practices of recruitment. see andrea m. braverman, how the internet is reshaping assisted reproduction: from donor offspring registries to direct-to-consumer genetic testing, 11 minn. j.l. sol. & tech 477, 482 (2010). 35 rosas, supra note 32, at 415. 36 wash. rev. code § 26.26.750 (2013). 2014 41 indiana health law review ii. truth-telling is truth-telling always preferable over family secrecy? disclosure proponents commonly answer "yes." family secrets, particularly in the context of reproduction, are assumed to be "like time bombs ticking away":37 they create ongoing tensions and taint familial communication to an extent that is psychologically damaging to the child.38 consequently, disclosure proponents argue, the child is always better off knowing the truth, earlier rather than later, and, in fact, it is the child's inherent right to have such information. 39 whether the emotional and psychological strain experienced in families where a child's genetic origin is concealed justifies disclosure is dubious, however, and caution is needed when assessing the impact of familial tension or, conversely, the beneficence of truth-telling on the child. the reality is that familial tensions exist for a variety of reasons; eliminating all family secrets is unrealistic. furthermore, the effects of secrecy vary significantly among family members; knowing beforehand how detrimental such secrecy would be, if at all, is thus impossible. as carol smart stipulates, "both 'telling' and 'not telling' will have consequences and the idea that the keeping of secrets is detrimental, whereas openness is innocuous, is itself problematic."40 additional factors support this latter argument. first, studies have shown that some donor-conceived children raised by heterosexual couples expressed anger and frustration when disclosure occurred during the course of a 37 carol smart, law and the regulation of family secrets, 24 int'l j.l. pol'y & fam. 397, 399 (2010). 38 glenn mcgeel et al., gamete donation and anonymitydisclosure to children conceived with donor gametes should not be optional, 16 hum. reprod. 2033, 2034 (2001). 39 see vardit ravitsky, "knowing where you come from "' the rights of donor-conceived individuals and the meaning of genetic relatedness, 11 minn. j.l. sci. & tech. 665, 670-71, 683 (2010) [hereinafter ravitsky, knowing where you come from]. 40 smart, supra note 37, at 400. 42 vol. 11:1 disclosure of gamete donation traumatic event such as divorce. 41 conversely, no difference in the rates of separation or divorce between disclosing and non-disclosing parents was found.42 it is thus difficult if not impossible to know what part of a child's negative reaction can be attributed to disclosure and what part is due to the distress caused by divorce, or some similarly difficult, lifechanging event. nor are there, to my knowledge, any studies that prove that families with donor-conceived children ("donor-conceived families") have a higher incidence of discord than non-donor-conceived-families. why assume then that donor-conceived children adjust any less to tensions within their families than their non-donorconceived peers? children are born into families with an array of other possible stress-factors, such as economic difficulties, ethnic discrimination, parental discord, or death of a caretaker, and they normally cope with them as a part of their life-story. thus, it is impossible, or at least highly speculative, to distinguish between the relative harms of secrecy versus other stress-factors. most importantly, one clearly cannot use a uniform approach to determine whether or not a specific donor-conceived child would benefit from disclosure; it has to be familyand childspecific. disclosure has other ramifications for recipient parents. although western liberal democracies have recently moved toward greater acceptance of familial pluralism, this shift is not universal. various religious and cultural communities have remained conservative in their approach, and the stigma and social price of barrenness are high. in orthodox jewish and islamic communities, for instance, a husband may be obligated by religious law or by social convention to divorce his wife on the ground of infertility, regardless of 41 akker, supra note 2, at 96; a. mcwhinnie, should offspring from donated gamete continue to be denied knowledge of their origins and antecedents? 16 hum. reprod. 807, 812 (2001). 42 emma lycett et al, offspring created as a result of donor insemination: a study of family relationships, child adjustment, and disclosure, 82 fertility & sterility 172, 175 (2004); susan golombok et al, parenting infants conceived by gamete donation, 18 j. fam. psychol. 443, 450-51 (2004). 2014 43 indiana health law review whether he is actually the one who is infertile.43 a married woman who uses donated sperm may simultaneously be seen as committing infidelity and illegal sexual intercourse. 44 for such couples who decide to use donated gametes anyway, a universal disclosure policy would, in effect, doom them to social isolation. persistent inequalities between genders exacerbate the harm, and, most likely, this social isolation would be principally experienced by women. donor-conceived children are likewise at risk of social exclusion on religious and cultural grounds. in orthodox judaism, because artificial insemination of a married woman with sperm of a jewish donor is considered adultery, a child born in such a way is classified as a bastard.45 this status, which extends also to children born out of incest relationship, holds significant implications; it bars the child from participating in and marrying within the religious community. using non-jewish sperm donors overcomes these religious complexities as halakhic law defines the act of adultery to require that both parties of the illicit sexual intercourse be jewish.46 moreover, because the halakhic construction of relatedness is such that a non-jewish sperm donor is not viewed as establishing any kind of relationship with the child, "children born to different jewish mothers from the same [non-jewish] donor are not considered to be 43 marcia c. inhorn, global infertility and the globalization of new reproductive technologies: illustrations from egypt, 56 soc. sci. & med. 1837, 1842, 1846 (2003). 44 zahra & shafie, supra note 7, at 162-63. 4 susan martha kahn, reproducing jews: a cultural account of assisted conception in israel 96-103 (2000) [hereinafter kahn, reproducing jews]. note that halakhic interpretations make a distinction between artificial insemination, where the sperm is introduced directly into the woman's tract and unequivocally prohibited due to the concern that it constitutes adultery, and ivf fertilization and embryo transfer for which there is no direct prohibition as it is not viewed as violating the biblical teaching that "[tlhou shalt not implant thy seed into thy neighbor's wife." id. at 103-04 (citing leviticus 18:20). still, jewish sperm donor raise some other additional religious difficulties given the prohibition on masturbation and sperm procurement for reasons other than one's fulfilling his own obligation to procreate. id. at 94. 46 id. at 104-05. vol. 11:144 disclosure of gamete donation related in any way" and may even marry.47 subsequently, the question of anonymity also differs: whereas with jewish donors the concern of incest suggests that at least the rabbinical authorities should have access to the donor's identifying information, with respect to non-jewish donors there is "a denial of the need to know" and anonymity of donors is upheld.48 yet still, a non-jewish donor does not remedy all: while such conception would not result in a bastard child or create a risk for incest, the child would still be excluded, deemed as polluting the holiness of the jewish people and their lineage. 49 similar rejection exists also among some muslim groups. for example, although shi'a muslims may allow for egg and sperm donations, the practice is still socially problematic.50 the recipient parents' endorsement of the donor-conceived child as their own does not necessarily translate into acceptance by the child's social kin and extended family of the recipient parents.51 unique characteristics of american society play further into this debate over secrecy. unlike its scandinavian counterparts, the united states is an immigrant, multicultural society comprised of multiple religious and cultural communities. its creed of non-interference in an individual's religious and cultural beliefs and practices is also particularly strong. thus, it is not only questionable whether it is within the law's legitimate role to regulate family secrets, but demanding disclosure would also unduly impose a set of principles that are not universally shared and would unnecessarily burden infertile parents and donor-conceived children. mandatory disclosure would virtually guarantee that members of such religious groups who want to disobey religious restrictions on gamete donation would practically be forced to leave their group, contrary to the non-interventionist spirit. 47 id. at 105. 48 id. at 79, 165-66. 49 id. at 93-107; wahrman, supra note 8, at 131-33. 50 inhorn, supra note 43, at 1847, 1847 n.4. 51 smart, supra note 37, at 401. 2014 45 indiana health law review the claim for universal preference of truth-telling raises two other issues. the first is that it implies that disclosure of the circumstances of one's conception-rather than the donor's identity-is needed to prevent or alleviate familial tension. this point emerges as disclosure proponents advocate, as mentioned above, for a two-tiered "right to know."52 evidently, this construction is aimed at heterosexual couples, who, in contrast to same-sex couples or single mothers, can conceal the fact of gamete donation, particularly if the intended mother carries the pregnancy. indeed, studies show that also in countries where the national law abolished anonymous gamete donation, heterosexual recipient parents do not disclose the donation to their child.53 but what is the scope of this new child's right to know the circumstances of his or her conception? gamete donation would be one extreme, but should we demand from parents to disclose also parental resort to fertility medication (and its type), and information relating to ivf treatment(s)? where do we draw the line between parental privacy and the child's right to know? the prevalence of the practice of art does not mean that parents necessarily want to share such experience with others, including their children. the situation is further complicated by practical policy issues. given that gamete donors' records may have been destroyed, a requirement of disclosure may result in the donor-conceived child experiencing strong frustration and anger towards the recipient parents with no remedy available to either of them to resolve the tension. thus, even if open and candid relationships between parents and children are preferable, 54 it is questionable whether the benefit of knowing the circumstances of one's conception when, practically 52 frith, beneath the rhetoric, supra note 3, at 473. 53 akker, supra note 2, at 96. 54 the practice comm. of the am. soc'y for reprod. med. & the practice comm. of the soc'y for assisted reprod. tech., am. soc'y for reprod. med. and soc'y for assisted reprod. tech., recommendations for gamete and embryo donation a committee opinion, 99 fertility and sterility 47 (2013) (most recent recommendations of disclosure by the asrm). vol. 11:146 disclosure of gamete donation speaking, further information about the donor may not be available, outweighs the harm of not knowing at all. the second issue revolves around the question of, if disclosure of gamete donation is indeed paramount, what sort of responsibility do we as a society owe donor-conceived children to ensure that they know the truth. this is especially so if access to a donor's information is conceptualized as a legal, rather than a moral, right. indeed, one of the most important aspects of a right is that the bearer of rights can exercise it independently. but in the context of gamete donation, the terminology of rights is elusive. as the overwhelming majority of donor-conceived children born to heterosexual couples-including those born in countries that reversed the policy of anonymity-are not told about the circumstances of their conception,5 5 the child's right is practically subjected in its entirety to the discretion of others. thus, if truth-telling in family relations is deemed vital as a societal value and as a right, "active registries" seem to be the ideal solution.56 in the case of active registries, the burden would be on the registry to contact the children once they have reached a certain agreed-upon age to inform them about their genetic origins and provide them with an opportunity to learn about the identity of their genetic parents or parents.57 alternatively, the law could require, for instance, that birth certificates include an addendum stipulating the child's circumstances of conception, as has been adopted in victoria, australia, and considered in the united kingdom and in new south wales, australia.58 55 akker, supra note 2, at 96. 56 cohen, rethinking sperm-donor anonymity, supra note 20, at 445-47. 57 1d. 58 victorian assisted reproductive treatment act 2008, (vic) s 153 (austl.); eric blyth et al., the role of birth certificates in relation to access to biographical and genetic history in donor conception, 17 int'l j. child. rts. 207 (2009); patrick lion, sperm donors' secret details tagged on birth certificates, the daily telegraph (feb. 17, 2012; 12:00 am), http://www.dailytelegraph.com.au/archive/nationalold/sperm-donors-secret-details-tagged-on-birth-certificates/storye2014 47 indiana health law review undoubtedly, such active registries would harmonize the child's right to know and the preference for truth-telling in family relations. but for a legal right to know, active registries are still insufficient. children conceived to mothers after occasional or multiple-partner sexual intercourse may not know their genetic father. 59 other presumed father-child relationships may turn out to be false. physicians facing cases of "misattributed paternity," where the familial relationship is unintentionally refuted during medical diagnosis and treatment, do not necessarily disclose such sensitive information.60 moreover, studies have shown that among traditional heterosexual families, a marked number of fathers-in the united states this is estimated at ten percent 61 ; in the united kingdom it is one 6freuzr-1226273279109; see also ravitsky, knowing w1here you come from, 681-2. 59 cohen, rethinking sperm-donor anonymity, supra note 20, at 443. 60 kenneth prager, professor of clinical med. and chair of the nyp ethics comm., address at the gold foundation ethics for lunch series: ethics for lunch: misattributed paternity (nov. 30, 2010); see also cohen, rethinking sperm -donor anonymity, supra note 20, at 44345 (raising a similar point). 61 jane alfred, flagging non-paternity, 3 nature rev. genetics 161 (2002). it is difficult to know whether this rate is accurate. media reports and organizations dedicated to revealing "paternity fraud" claim that the rate is as low as 14% and up to as high as 30%. paternity fraud rampant in the us., wnd (feb. 18, 2006), http://www.wnd.com/2006/02/34861/ (last visited nov. 13, 2013); see also, paternity fraud ctr., www.paternityfraud.com. conversely, the american association of blood bank, the only organization in the united states to collect information about relationship genetic testing from approved laboratories, suggests in its 2010 annual report, the latest available, that the average exclusion rate of paternal relationships is 20.44% with a standard deviation of 6.62. however, this percentage includes testing following a mother's request to determine who among a few possible men is the father or when the recognized man raises a question of infidelity after which a few other possible men are tested, leading the organization to conclude that "[t]here is no evidence that a large number of the men excluded in the testing were misled into believing they are the biological father of a given child." annual report summary for testingin 2010, aabb 4, http://www.aabb.org/sa/ facilities/documents/rtannrpt10.pdf; see also sally macintyre & anne sooman, non-paternity and prenatal genetic screening, 338 lancet vol. 11:148 disclosure of gamete donation out of seven fathers-may unknowingly raise children that are genetically unrelated to them.62 should a disclosure policy apply to those children as well? if the child's right to know should necessarily prevail, naturally-conceived children should not have any less of a right to know about their genetic origins. it further follows that society at every level, from government agencies to medical professionals who perform the procedure down to the individual, must take appropriate measures to ensure that this right can be exercised. the possibility of such an active registry, or its alternative in the form of birth certificate addendum, is further problematic in the united states context. first, it is doubtful that such an option would withstand the test of privacy law in medical practice or family relations. with regard to the first, the physician-patient relationship generally enjoys the privilege of confidentiality. while it has been suggested that this privacy can be revoked in the context of lethal infectious diseases, for instance, informing the intimate partner of a person who is an hiv/ aids carrier, the general consensus is that it is the patient who should be warned about the risks and encouraged to act upon that risk by warning others. 63 a similar approach has been taken with regard to the diagnosis of genetic disorders among family members. 64 while the possibility that a 869 (1991); kermyt g. anderson, how well does paternity confidence match actual paternity?, 47 curr. anthropology 511, 513 (2006). 62 mcwhinnie, supra note 41, at 814; see also cohen, rethinking sperm-donor anonymity, supra note 20, at 443-45 (raising a similar point). 63 see generally laura lin & bryan a. liang, hv and health law: striking the balance between legal mandates and medical ethics, 7 virtual mentor, oct. 2005, http://virtualmentor.amaassn.org/2005/10/pdf/hlawl-0510.pdf, but see tarasoff v. regents of the univ. of cal., 551 p.2d 334 (cal. 1976) (establishing the legal duty of psychotherapist to warn a third party of foreseeable harm where there was a clearly identified victim). 64 see pate v. threlkel, 661 so. 2d 278 (fla. 1995) ("our holding should not be read to require the physician to warn the patient's children of the disease. in most instances the physician is prohibited from disclosing the patient's medical condition to others except with the patient's permission. . . . moreover, the patient ordinarily can be 2014 49 indiana health law review physician may have a broader duty to take reasonable steps to warn those likely to be affected has been raised,65 in both legal and bioethics scholarship and practice the first interpretation has prevailed. 66 a requirement that the professionals who carried out donor-insemination would have an obligation to report identified patients seeking art67 to other third parties, including nationalor statelevel agencies, in the absence of health risk would thus require a major revolution in medical practice in the united states. this issue is further complicated by considerations of privacy in family relations. the family institution in the united states is commonly awarded significant leverage in its internal affairs; it is seen as almost sacred from public intervention. however, in the lack of a national or expected to pass on the warning. to require the physician to seek out and warn various members of the patient's family would often be difficult or impractical and would place too heavy a burden upon the physician. thus, we emphasize that in any circumstances in which the physician has a duty to warn of a genetically transferable disease, that duty will be satisfied by warning the patient."). 65 safer v. estate of packo, 677 a.2d 1188 (n.j. super. ct. app. div. 1996); see also molloy v. meier, 679 n.w.2d 711, 719 (minn. 2004) (holding that "a physician's duty regarding genetic testing and diagnosis extends beyond the patient to biological parents who foreseeably may be harmed by a breach of that duty."). the specific circumstances of the case are important to note. the physicians were negligent primarily because they did not follow the standard of care of testing for fragile x disorder although they suspected it to be the case and the child clearly exhibited associated developmental delays. molloy, 679 n.w.2d at 716. there is a high probability of genetically transmitting this disorder and a reliable, acceptable and widely available test for it; and further worse, the physicians gave the biological mother the impression that they have tested the child for this genetic disorder and that it was negative whereas in fact, the test was not performed. id. at 719. 66 faith lagay, a physician's role in informing family members of genetic risk, 7 virtual mentor, june 2005, http://virtualmentor.ama-assn.org/2005/06/pdflhlawl-0506.pdf. 67 i distinguish here between reporting on number of (nonidentified) patients who receive treatment and the subsequent number of successful (or unsuccessful) conceptions and births, which may be required for statistic purposes and are legitimate to require, and the provision of identifying information about patients (who received treatment). my concern refers to the latter. 50 vol. 11:1 disclosure of gamete donation comprehensive state-level registry of donor-conceived children in the united states, and if indeed all children have a right to know their genetic origin, the only alternative for the aforementioned active registry or the birth certificate addendum would be to issue birth certificates only once the newborn is tested for genetic compatibility with the putative parents. if the genetic match fails, a note to this affect would be recorded on the child's birth certificate. surely such a measure is highly intrusive to a family's privacy and contrary to american creeds. moreover, while the state has the responsibility of parens patriae to protect its young citizens, also at the cost of familial privacy, this responsibility is generally activated only once the familial environment has failed. it is a measure of last resort, not first. thus, for instance, courts generally support interfering with parental rights and prerogatives only when the child's physical health or safety is in serious danger.68 conversely, when the family is functioning well and the children are age-appropriately developed, the legal parents exercise discretion over how they raise their children and what values they pursue. with no further data about the harmful effects of the secrecy of gamete donation and whether they amount to forms of child neglect and abuse that justify intervention,6 9 establishing an active registry and its alternatives, as would logically be required for a donor-conceived child's legal right to know, may thus be an inappropriate use of governmental power. 68 see, e.g., lori g. beaman, religion and rights. the illusion of freedom and the reality of control, 6 culture & religion 17-29 (2005) (discussing the case of bethany hughes, a minor and a jehovah's witness member who refused a blood transfusion for cancer treatments.) the court in that case dismissed her argument that she should not be forced to receive the treatment on the basis of her right to religious freedom. alberta (director of child welfare) v. b.h., [20021 6 alta. l.r. 4th 34, 11 w.w.r. 752 (can. alta. q.b.). see also, e.g., jehovah's witness v. king cnty. hosp., 278 f. supp. 488 (w.d. wash. 1967), affd, 390 u.s. 598 (1968). 69 maya sabatello, are the kids alright? a child-centred approach to assisted reproductive technologies, 31 neth. q. of hum. rts. 74, 81-87 (2013) (discussing art as a form of child's neglect and abuse). 2014 51 indiana health law review second, the relatively conservative definitions of "family" in the united states, as compared to other western countries, should be borne in mind. as scholars studying the united states judicial system have observed, in cases concerning art-related disputes courts tend to accept the claimant whose familial structure follows the traditional heterosexual one of "one female mother, one male father (both married to each other). "70 furthermore, although some changes in the judicial understanding of family relations, in light of art, have certainly occurred,71 the inclination towards a traditional family structure comprised of only two parents, whether heterosexual or same-sex couples, remained; indeed, this two-parents-only family structure is almost exclusively endorsed also in parentage laws and courts' decisions in the united states.72 this is significantly different from the situation in many other western countries where there has been an increasing legal acceptance of the pluralism of family structures and combinations of family relations, from same-sex couples to cohabiting heterosexual partners to recognition of three 70 janet l. dolgin, defining the family: law technology and reproduction in an uneasy age (1997), cited in legge et al., supra note 24, at 18; see also melanie b. jacobs, wy just two? disaggregating traditional parental rights and responsibilities to recognize multiple parents, j.l. & fam. stud. (forthcoming), available athttp://papers.ssrn.com/sol3/papers.cfm?abstractid=1012333. 71 janet l. dolgin, the fractionalization of 'parent transformations in society and the law, 5 expert rev. obstetrics & gynecology 665 (2010). 72 diane m. goodman, why can't children have three parents?, l.a. law, dec. 2011, at 36 (2011-2012) [hereinafter goodman, why can't children]. see also, e.g., mcdonald v mcdonald, 608 n.y.s.2d 477 (1994) (dismissing the ex-husband challenge of the wife's legal parentage as she used egg donation to conceive); johnson v calvert, 851 p.2d 776 (cal. 1993) (granting the legal parentage to the intended and genetic mother in a case of gestational surrogate, where the surrogate has no genetic tie to the child). more recent cases also determined that two mothers in a same-sex relationship could both be registered as the legal parents. see, e.g., k.m. v. e.g., 117 p.3d 673 (cal. 2005) (revolving around a genetic and gestational mothers); elisa b. v. super. ct., 117 p.3d 660 (cal. 2005) (finding that the two mothers were the legal parents); in re parentage of robinson, 890 a.2d 1036 (n.j. super. ct. ch. div. 2005). 52 vol. 11:1 disclosure of gamete donation legal parents. 73 thus, whereas in victoria, australia, and new zealand, 74 for instance, a requirement for registration 73 the netherlands, belgium, spain, norway, portugal, iceland, sweden, denmark, and canada have all adopted laws recognizing samesex marriages. other countries that recognize civil unions of both same sex couples and unmarried heterosexual couples on the national level include the united kingdom, new zealand and germany. additionally, israel, france and japan recognize same sex marriages performed in other countries. in the united states, in contrast, the law lags behind. in the aftermath of the supreme court's decision in united states v. windsor, 133 s. ct. 2675 (2013), the obama administration has decided to reconsider the status of same-sex couples for immigration and federal tax purposes. however, recognition of same-sex marriages is not nationally required but dependent on the individual states, and currently, most of the states still do not recognize same-sex marriage. further, in stark difference from other western and european countries, cohabitant heterosexual relationship are not recognized as a matter of federal policy for issues such as immigration, taxation, and healthcare benefits. david masci et al., gay marriage around the world, pew res. ctr. (july 9, 2009), http://www.pewforum.org/gay-marriage-andhomosexuality/gay-marriage-around-the-world.aspx; gay marriage legalities worldwide, gay wedding destinations, http://www.gayweddingdestinations.com/information/gay-marriagelegalities-worldwide.aspx (last visited nov. 15, 2013). for multi-parents structures, see, e.g., r.a. and g.d. v. family of bereaved benefits officer delivered by the israeli rishon lezion magistrate court (application 41988-03-11), delivered february 3, 2013 (recognizing the deceased lesbian partner as the surrogate parent of the child, in addition to the child's biological father and mother.) see also susan donaldson james, my three daddies: california eyes multiple parenting law, abc news, july 3, 2012, http://abcnews.go.com/health/ gmahealth/california-considers-bill-multiple-legal-parents/story?id= 16705628. 74 legge et al., supra note 24, at 22-23. see in this regard also the order of district court in new south wales, australia, that the sperm donor is removed from the birth certificate of his daughter with whom he had maintained a relationships and financial support since birth, given the right of the birth mother's former partner to be named on the register. as the law allows for the registration of only two parents, the court ruled in favor of the two mothers, while also suggesting that that "the law should be rethought to allow for three parents to be listed on a birth certificate" given "the inadequacy of laws dealing with multiparent families." oliver timmis, lesbian couple have sperm donor removed from birth certificate, bionews, august 22, 2011, http://www.bionews.org.uk/page_104979.asp; aa v registrar of births 2014 53 indiana health law review of genetic ties on the birth certificate may simply feed into the societal acceptance of the diversity of non-traditional family structures, in the united states it is likely to yield the opposite result. given previous experience, and unless measures are simultaneously taken to broaden the legal acceptance of non-traditional families and the possibility of a "multiparent model" that includes more than two parents, a requirement of registration of donor conception on the birth certificate runs the risk that it would merely exacerbate the stigmatization of such non-heterosexual and non-genetic families and donor-conceived children rather than further their welfare and best interests. in a parenthood dispute between a lesbian couple and sperm donor, for instance, the donor might prevail over lesbian couple simply because of the judicial perception that the same-sex parents do not form an intact family, or because of a conservative belief that a father is essential for the child's well being. 75 finally, adopting an active registry in the united states is problematic also given the phenomenon of reproductive tourism, where individuals and couples travel to receive medical treatment in countries other than their own. although exact data on the scope of the phenomenon in the united states in unavailable, there is no doubt that the united states is an active player in this market. as most industrialized countries prohibit the commercialization of gamete donation, especially egg donation, as well as of other deaths and marriages [20111 nswdc 100, (austl.), available at http://www.caselaw.nsw.gov.aulaction/pjudg?jgmtid=154026. 75 goodman, supra note 72, at 36; see also jhordan c. v. mary k., 224 cal. rptr. 530 (app. 1986) (accepting legal paternity suit of a known sperm donor who established relationship with the child and recognizing the biological mother's partner as de facto parent with visitation rights); but see jacob v. shultz-jacob, 923 a.2d 473 (pa. super. ct. 2007) (determining that a child may have three parents where a former lesbian couple and the sperm donor who established relationship with the resulting children were all held as having some parental duties and rights). note that in those cases the sperm donor was known, the medical procedure was not undertaken by a physician, and while the parties disagreed as to their arrangements for future relationship with the child, in practice, the genetic father had already established such relationship with the child. 54 vol. 11:1 disclosure of gamete donation art-related services (including surrogacy and in some countries gamete donation76), the united states has turned into a leading international destination for couples and individuals from other countries.7 7 should the united states extend its hands to donor-conceived children born to foreigners who come to the united states for gamete donation, sometimes in contravention of their own national laws?7 8 if the child's right to know is universal, as argued, the answer to this question should be positive. this however would significantly hamper the lucrative multibillion per year business in the united states,7 9 while also contravening principles of states' jurisdiction and creating a real challenge to the law's implementation. moreover, the chances are that recipient parents, both foreign coming to the united states and americans who want to circumvent the active registry, will not give up their desire for privacy in establishing a partially biologically related family and will instead travel to other locations to purchase gametes and art services, often without governmental supervision, while others will turn to the black market. both scenarios hold significant health risks to the recipients, the donors, particularly egg donors, and the future donor-conceived child. importantly, these scenarios will also yet again undermine the law's purpose of ensuring that the right of a donor-conceived child to know is upheld. 76 see s.h. v. austria [gc], no. 57813/00, echr, nov. 17, 2011, available at http://hudoc.echr.coe.int/sites/eng/pages/search.aspx?i=001107325. 77 smerdon, supra note 15, at 21-22. 78 egg and sperm donation for ivf are banned in austria and italy; germany and norway allow sperm donation but ban egg donation. maria cheng, strict fertility treatment bans in europe draw criticism, us today news, mar. 4, 2012, http://usatoday30.usatoday.com/news/health/story/2012-04-13/europefertility-bans-limits/54250984/1. 79 hundreds of sperm banks, egg banks, private and independent clinics, surrogacy agencies, and other related services were established in the past few decades around the world and generate billions of dollars per year. michael j. malinowski, creating life, examining the legal, ethical, and medical issues of assisted reproductive technologies: a law-policy proposal to know where babies come from during the reproduction revolution, 9 j. gender race & just. 549 (2006). 2014 55 indiana health law review truth-telling is an important, but not absolute, value. this is especially so in the context of reproduction and gamete donation: the possibility of disclosure has to be balanced with the potentially serious repercussions on the recipient parents, donors, and donor-conceived children that may occur. these repercussions necessitate a clear line between disclosure and inappropriate interference in one's privacy that is not easy to draw. importantly, if truthtelling is the paramount value and a legal right, it should apply to all children, whether conceived naturally or through gamete donation, and would require that we, as a society, consider what measures we are willing to adopt to ensure that the truth is, under all circumstances, being told. such discussions also require that we rethink how family is conceptualized in the united states. moving toward a greater legal and social acceptance of the diversity of nontraditional and non-genetically related familial structures and combinations is certainly more reflective of reality, and, thus, is critically important for families and children who are raised in such familial structures. but making a legal change only in the context of disclosure of gamete donation without a concomitant to broader social changes that accept non-traditional and multiparent families invites backlash especially for donor-conceived-families and the children themselves that are involved. iii. identity formation disclosure proponents raise another argument: the importance of information about genetic origin for the child's identity formation. as vardit ravitski explains, "the development of personal identity requires understanding 'where you came from'. . . it means knowing what the donor is like in ways that would help offspring understand why they are the way they are."8 0 commonly, an analogy is drawn from adoptees, where studies have shown the devastating impact their abandonment and the lack of information about their 80 ravitsky, knowing where you come from, 665, 674. 56 vol. 11:1 disclosure of gamete donation genetic parents have had on their identity development and sense of worth and belonging. 81 disclosure proponents similarly suggest that donor-conceived children face "genealogical bewilderment," poor self-perception and identity crises, and a sense of being an outsider among the family in which he or she is raised.82 they subsequently insist that a disclosure policy, akin to the one currently in place with adoptees, should be implemented. these suppositions are problematic. the argument about the indispensability of knowing one's genetic origin insinuates that genetics is equated with identity. while certain characteristics are influenced by one's genes (e.g., temperament and appearance), such an understanding of identity overemphasizes genetic composition and underestimates other facets of identity. as the feminist movement and, subsequently, the disability rights movement have so fervently emphasized, identity formation is about more than genetics. significantly, one's web of relations is paramount. this is particularly so with regard to children. contrary to the essentialist-genetic notion of identity, studies show that children's identity is fluid; pluralistic; and dependent on their social and familial relationships and ethnic, religious, and cultural backgrounds. 83 this diversity is especially pertinent. unlike in western 'liberal culture, some religious and cultural groups residing in the united states do not hold genetics as establishing any relatedness with the resulting child, especially with respect to the genetic father.8 4 it is thus hard to imagine that members belonging to such groups would nonetheless find knowing one's genetics origin as essential for one's identity formation. 81 frith, beneath the rhetoric, supra note 3, at 47980. 82 akker, supra note 2, at 96; mcwhinnie, supra note 41, at 814; michelle dennison, revealing your sources: the case for nonanonymous gamete donation, 21 j.l. & health 1, 16-17 (2007). 8 maya sabatello, children's bioethics: the international biopolitical discourse on harmful traditional practices and the right of the child to cultural identity 215-20 (2009) [hereinafter sabatello, children's bioethics]. 84 see discussion supra part i (discussing orthodox judaism); see also discussion infra part iii. 2014 57 indiana health law review whether donor-conceived children's process of identity formation differs from that of naturally conceived children is hard to assess. instances of identity crisis have been reported with respect to donor-conceived children raised by same-sex or single-parent families, where the absence of a genetic parent is obvious and no information about the donor is available, or in heterosexual families when disclosures occurred in traumatic circumstances. further, most studies conducted are biased as samples were taken from online registries for recipient parents or donorconceived siblings, who clearly are already invested in learning about their genetic parent. conversely, no studies have established a prevalence of identity crises among the millions of existing donor-conceived children-particularly among those who do not know-and whether it is beyond what all children experience as they mature. and considering that gamete donation commonly remains a secret from the closest family members, including the donor-conceived child, there is little evidence to suppose that the price of anonymity to the donor-conceived child's identity development is as severe as is argued by disclosure advocates. requiring disclosure may thus catalyze invasive interventions in families that are actually thriving with well-developed and satisfied children. before the concomitant policy change is implemented, further studies are needed to determine the correlation of identity development to disclosure and non-disclosure among donorconceived children. for this reason, comparing donor-conceived children to adopted children is inapt: whereas adoptees were, for whatever reason, abandoned by their genetic parents, donor-conceived-children were intended and desired all along. adoptees' anger and frustration may also be influenced by their memories, even if vague, as they may have experienced or witnessed traumatic events that led to their adoption (e.g., child abuse), experiences that donorconceived children do not share. concluding, without appropriate studies, that donor-conceived children necessarily share the complex identities of adoptees is thus vol. 11:158 disclosure of gamete donation erroneous and presumes identity crises where they may not exist. this information-translated-into-identity debate must confront another privacy matter: how much information about one's donor would be required to satisfy the donorconceived-child's sense of identity? besides donors' medical data, recipient parents have begun requesting other details such as childhood and adult pictures and in-depth psychosocial histories, such as a donor's earliest memory; favorite book and movie or other hobbies; whether a donor prefers certain weather; and the ways in which a donor shows his or her love.8 5 such requests suggest that this information is somehow tied with genetic traits or that it is otherwise important to personalize the donor 86 and thus important to enable the donor-conceived child's to develop his or her identity. this latter suggestion, which is at the heart of the information-translated-into-identity debate, is problematic on a few levels, however. if knowing about one's genetic origin and the characteristics of the donor is so crucial to one's identity, making it a legal obligation from donor to provide such information is justified. but what are the limits? for instance, whether the legal requirement of providing other information such as the donor's sexual behavior and other personal crises should be considered. such information is deeply personal and should be protected as a matter of privacy. simultaneously, the factual basis on which this suggestion rests is tenuous at best. not only that, it is not at all clear what is the connection between genetics and such characteristics-for instance, whether weather preference has anything to do with genetics-but it also assumes that there is one "real" identity that the donor-conceived child will develop once the information about the donor is provided. this however is not the case: studies on children's identity have established that children 85 braverman, supra note 34, at 485, 492. 86 id. at 492-93. 2014 59 indiana health law review have their own identities that differ from the identities of their parents.8 7 concurrently, a further question arises: can information rather than an actual relationship ever be enough? indeed, in other countries that made the provision of personal information such as a family tree and whether the donor was adopted a requirement, such as has been the case in new zealand and victoria, australia, the donor-conceived child also has the right to contact the donor and establish an actual relationship with him or her. yet again, in the united states context, this would require a real revolution in the understandings of families, which is unlikely to be endorsed by american society any time soon. it would also require that donors reconceptualize their donation to mean familial relationship rather than an economic transaction;8 8 however, this, too, would be difficult to achieve. studies show that in countries that adopted a disclosure policy, the number of gamete donors dropped significantly.8 9 subsequently, long waiting lists now exist for couples and individuals who resort to gamete donation, whereas those who can afford it travel to the united states and to other destinations where donors' anonymity is upheld.90 thus, 87 judith ackroyd & andrew pilkington, childhood and the construction of ethnic identities in a global age, 6 childhood 445 (1999); see also sabatello, children's bioethics, supra note 83, at 177-82 (discussing the complexities of children's identities). 88 see discussion infra part iii. 89 frith, gamete donation, supra note 4, at 822-23. note that the permanency of this decline has been disputed; however, there is no doubt that the immediate result is greater limitations on the possibilities of recipient parents to create a family and on the ability of fertility clinics, a strong lobby in the united states, to provide services. see i. glenn cohen, the right not to be a genetic parent?, 81 s. cal. l. rev. 1115 (2008) (arguing for a right not to be a genetic parent because of the harm caused by what he terms "attributional parenthood"; that is, the fact that society assigns the status of parent to the provider of genetic material also when the legal system absolves the genetic parent from any parental responsibility). 90 in the netherlands, for instance, the waiting list for sperm donation stands on two years; in the united kingdom recipient parents may wait three to five years for egg donor. new law affects sperm donation in the netherlands, bionews, june 4, 2004, vol. 11:160 disclosure of gamete donation while providing extensive information, and allowing for actual relationships, can be optional, making it obligatory necessitates consideration as to what constitutes a reasonable expectation for information and what the broader implications of such a change are. the issues highlighted here are not intended to dismiss or undermine the feelings of frustration or identity crises expressed by donor-conceived children who know about their conception story but have no recourse, as the information about the gamete donor is unavailable. indeed, recipient parents should take seriously these feelings, especially when gamete donation is obvious or when recipient parents intend all along to tell the child about the circumstances of his or her conception. rather, what this discussion intends to show is that the identity-formation claim is not as absolute or straightforward as suggested by disclosure proponents. it is socially constructed --a point that is further strengthened given that the calls for disclosure do not necessarily represent all recipient parents and their donor-conceived children, and given the number of children unknowingly raised by a biologically unrelated parent whom are seemingly well-developed. more studies about the identity development of donor-conceived children are thus essential before changes in the law are adopted so to ensure that they resonate with children's needs. iv. the genetic tie a third argument that disclosure proponents raise is that genetic ties create an intrinsic emotional attachment; a donor-conceived child, it is so argued, then has a right that this connection be realized through the provision of disclosing identifying information. 91 others have suggested that this right should include access to the donor's full http://www.bionews.org.uk/page_1 1973.asp; a review of the hfea's sperm and egg donation policies 2011, supra note 14, at 3. 91 eric blyth, to be or not to be? a critical appraisal of the welfare of children conceived through new reproductive technologies, 16 int'l j. child. rts. 513 (2008); mcwhinnie, supra note 41, at 815. 2014 61 indiana health law review identity to enable the donor-conceived child to develop a relationship with the genetic parent.92 contrary to this assumption, research has shown that the genetic tie is largely a social construct that is not universally upheld. among african americans, for instance, the notion of the family is often politically, and not genetically, constructed. it is a matter of sisterhood and brotherhood in one's political environment.93 similarly, for religious rationales, orthodox judaism does not hold nonjewish genetic fathers as establishing any paternal relatedness with a child born to a jewish woman.94 likewise, among indigenous groups such as the navajo nation in the united states and the residents of the trobriand islands, new guinea, the genetic bond is associated only with mothers. 95 the father is not viewed as having a direct connection with the child's conception, and the father-child relationship is established only as a matter of marriage, rather than as a matter of biology. and, in fact, also within western culture, parenthood, and particularly fatherhood, was never a natural certainty but a legal fiction to ensure inheritance and lineage rights.9 6 the presumption of genetic tie as creating an intrinsic sense of attachment is also not grounded in reality. numerous children around the world are abandoned each year by one or both of their genetic parents, whether in hospital maternity wards or later on. in some instances, children are deserted in a careless way, without a notice, or thrown into the garbage bin. the adoption of so-called "safe haven laws" in various countries, such as france and germany, and many states in the united states are illustrative of this phenomenon: parents may relinquish 92 ravitsky, knowing where you come from, supra note 39, at 677-79. 93 dorothy e. roberts, the genetic tye, 62 u. chi. l. rev. 209, 232 (1995). 94 kahn, reproducing jews, supra note 45, at 105. 95 cohen, the right not to be a genetic parent., supra note 89, at 1140-41. 96 ellen waldman, the parent trap: uncovering the myth of "coerced parenthood" in frozen embryo disputes, 53 am. u. l. rev. 1021, 1028 (2004). vol. 11:162 disclosure of gamete donation unwanted newborns in certain designated areas or authorities, and they may do so without leaving any identifying information.97 the presence of a genetic link as an indication of attachment has also been repeatedly challenged in the case of gamete donors. studies show that gamete donors, particularly sperm donors, are largely unconcerned with the offspring created from their gametes, have no sense of attachment to the potential offspring, and do not want to meet them in the future.98 additionally, the rationales for gamete donation are often far removed from any desire to create an attachment. donors, particularly men, are often motivated by financial interest, and some view their donations as not so different from blood donation. 99 nor is it clear that children give the same weight to genetic ties as do adults. research shows that for children's sense of familial attachment, genetics is not paramount; rather, it includes household members, pets, a range of relatives, and individuals from other households.100 studies of children born as a result of art to same-sex family structures further reinforce the finding of children's nongenetic sense of kinship. indeed, for these children, parentage is determined not so much by biological connection but by the way they were raised, and especially, the fact that they were planned and wanted all along. 101 97 see, e.g., ana l. partida, the case for "safe haven" laws: choosing the lesser of two evils in a disposable society, 28 new eng. j. on crim. & civ. confinement vol. 61 (2002); carol sanger, infant safe haven laws:legislatingin the culture of life, 106 colum. l. rev. 753 (2006). 98 waldman, supra note 96, at 1049-52. 99 id. at 1050. further note that, if the genetic tie is indeed so intrinsic in creating kinship relationship and merits its classification as a right, it is hard to see why donors who want to receive information about their related donor-conceived-children and even contact them should be prevented from doing so; it should further be questioned whether the power of gamete donors to simply waive such an intrinsic right is acceptable at all. 100 jennifer mason & becky tipper, being related. how children define and create kenshio, 15 childhood 453-56 (2008). 101 dena moyal, & carolyn shelley, future child's rights in new reproductive technology.' thinking outside the tube and maintaining 2014 63 indiana health law review within the limited given data regarding sperm donation, studies show inconclusive results. children younger than four years old in heterosexual families in sweden questioned how they were born but reacted neutrally or not at all to the issue of gamete donation. 102 in another study, over half of children between seven and seventeen years old who were raised by lesbian couples in belgium preferred donor anonymity and roughly 20% were satisfied with nonidentifying information, such as physical appearance and personality. sixty-three percent of these children also expressed no need in having conversations with their mothers about the donor.103 moreover, differences were found also among donor-conceived children raised in the same family, including siblings from the same donor, leading the researchers to conclude that the donor-conceived child's interest in learning about his or her genetic origin is an individual matter.104 conversely, in a study in australia, most adolescents from the general population, including unknown donor-conceived children among them, who were surveyed about their opinion about donor parentage acknowledged the significance of the genetic the connections, 48 fam. ct. rev. 431, 433 (2010); susan golombok et al., families created by the new reproductive technologies: quality of parenting and social and emotional development of children, 66 child dev. 285, 297 (1995); zaira papaligoura & colwyn trevarthen, motherinfant communication can be enhanced after conception by in -vitro fertilization, 22 infant mental health j. 591 (2001); jos6 gabilondo, heterosexuality as a prenatal social problem: why parents and courts have a taste for heterosexuality, in baby markets: money & the new politics of creating families 118, 124, 129, n.43 (michele bratcher goodwin ed., 2010). 102 sara leeb-lundberg et al., helping parents to tell their children about the use of donor insemination (di) and determining their opinions about open-identity sperm donors, 85 acta obstetricia et gynecologica scandinavica 78, 79 (2006). 103 k. vanfranssen et al., an attempt to reconstruct children's donor concept: a comparison between children's and lesbian parents' attitudes towards donor anonymity, 16 hum. reprod. 2019, 2021 (2001). 104 id. vol. 11:164 disclosure of gamete donation connection to the donor but still identified the legal father as the parent. 105 the degree to which these studies can be extended to donor-conceived children in the united states is unclear. the societal fabrics in all of these countries vary dramatically, and, generally, the above-mentioned international studies contain no information about religious and ethnic affiliation. studies in the united states are prone to bias: current studies commonly revolve around donor-conceived-adults-hence after the process of enculturation which endorses the importance of genetics to kinship-and relied heavily on online listserves established especially by donor-conceived families with nontraditional family structure, i.e. single mothers and same-sex couples, to connect and communicate among themselves. 106 without an appropriate mechanism to trace the births of donorconceived children in the united states, future studies will inevitably be biased as well. additionally, no studies appear to have examined whether the importance attributed to the genetic tie by the donor-conceived child differs depending on sperm and egg donation, particularly when the mother carried the pregnancy. american children's views about the significance of a genetic link should thus be further studied if we are to achieve a more accurate understanding of the consequences of disclosure in the united states. v. medical data finally, a principal argument raised by disclosure proponents is that knowing one's genetic origins is important for medical reasons. this issue often arises when donor-conceived children are in the process of or have been diagnosed with disorders that have or are thought to have 105 maggie kirkman et al., families working it out: adolescents' views on communicating about donor-assisted conception, 22 hum. reprod. 2318 (2007). 106 see, e.g., our history and mission, donor sibling registry, https://www.donorsiblingregistry.com/about-dsr/history-and-mission/ (last visited nov. 16, 2013). 2014 65 indiana health law review genetic links.107 disclosure of medical data is thus called for "in order to be aware of health risks, be able to take preventative measures, and have better ability to diagnose conditions as they emerge."108 disclosure proponents raise two other related arguments. the first concerns unwitting incest relations of donor-conceived children with half-siblings. this argument is particularly pertinent in the united states. unlike in other countries, there are no nationalor state-level records on the birth of donor-conceived children or limits on the number of families that can receive donations from the same donor as exists for instance in france, belgium, and the united kingdom. popular donors can thus father multiple children -n one reported case, sperm from one donor resulted in sixty-four children.109 incestuous relationships are socially unacceptable, and important for this discussion, they also increase the risk of genetic disorders if the siblings procreate. 110 the second related argument underscores the issue of reproductive choice: the availability of the donor's medical data may influence the parental decision of whether to use the gamete of the particular donor, not to mention donor-conceived children's own reproductive decisions later in life." a requirement for disclosure of gamete donors' medical information is the strongest among the arguments considered so far. this is not to say that the argument is without a hitch. on the contrary, there are some serious difficulties with the implied suggestion that the importance 107 ravitsky, knowing where you come from, supra note 39, at 671-74; vardit ravitsky, conceived and deceived, 42 hastings ctr. rep. 19 (2012); rosas, supra note 32, at 395-96. 108 ravitsky, knowing where you come from, supra note 39, at 671. 109 donor unknown: adventures in the sperm trade (met film and redbird 2010). 110 in many states in the united states and elsewhere (e.g., australia and the united kingdom) incest relations also constitute a criminal offense. naomi cahn, accidental incest: drawing the line or the curtail? for reproductive technology, 32 harv. j.l. & gender 59, 85-89 (2009). 111 ravitsky, knowing where you come from, supra note 39, at 672. 66 vol. 11:1 disclosure of gamete donation of genetic origins for medical reasons is universal and with proponents' effort to frame access to donor's medical information as a right, rather than simply as a legitimate interest. nevertheless, the argument holds true, especially given existing deficiencies in medical practice that prevent the appropriate and timely diagnosis of donor-conceived children who experience health-related symptoms that may be connected with genetic disorders. the following discussion thus aims to consider both the legal and ethical difficulties arising from the argument on the importance of medical data, ultimately concluding that the benefits of providing donor-conceived children access to such information do, in fact, outweigh the privacy concerns of gamete donors and recipient parents and justify the regulation of the work of fertility clinics in the united states. the relevance of the donor's medical information is certainly of interest for a donor-conceived child who experiences health symptoms and is in the process of a medical diagnosis. this interest can be reasonably extended to other potential recipients and future donorconceived children who may develop the health condition if the same donor is used or who are concerned about the possibility of unintentional incest with half-siblings and the subsequent increased risk of genetic disorders. demanding that gamete banks and fertility clinics perform due diligence in checking potential donors and establishing clear medical screenings of potential donors and guidelines to prevent donors diagnosed with genetic disorders from future donations are thus justified, as is limiting the number of families who use gametes from one donor so that the potential number of children born with genetic disorder that can be traced to the donor is reduced. yet the argument related to the importance of the donor's medical data is more complex than it initially appears. first, contrary to what disclosure proponents commonly imply, establishing causation between a health condition and inherited genetic disorders is not straightforward. many genetic disorders occur as a result of spontaneous mutations that cannot be attributed to the genetic 2014 67 indiana health law review parents 112 or involve complex groups of genes not yet identified (e.g., autism). simultaneously, it is generally agreed upon that human diseases have both genetic and environmental components to them, and that the interaction between these components is not fully known.113 the clinical usefulness of genetic testing may also be lacking. as klitzman denotes, diagnosis does not always translate into an effective treatment, yet patients commonly believe that it does even when told otherwise ("diagnostic misconception").114 concurrently, existing technologies in the fields of genetics and genetic counseling are often sufficient to diagnose donor-conceived children with known genetic mutations, to determine consanguine relationships, and to avoid the transmission of the more common disorders to the next generation through pre-implantation genetic diagnosis. thus, the donor-conceived child's access to a donor's medical, and especially genetic, information is not inherently necessary for diagnosis, nor can it necessarily provide the panacea for all ailments that donor-conceived children may experience. second, it is problematic and erroneous to generalize from cases where a donor-conceived child experiences health symptoms and is in the process of obtaining a medical diagnosis that all donor-conceived children, including especially asymptomatic ones, have a generalright to access the donor's medical and genetic data. children do not normally have a right to access the medical and genetic information of their parents. 115 they may request it when they are sufficiently mature and parents may choose to provide it, but this is not obligatory; indeed, medical secrets are often among the most guarded ones within families.116 classifying it as a right, however, creates donors' direct 112 rosas, supra note 32, at 412 n.172. us mark a. rothstein, gina, the ada, and genetic discrimination in employment, 35 j.l. med. & ethics 756, 838-39 (2008). 114 robert l. klitzman, am i my genes? 40 (2012). 115 see discussion supra (discussing physician's duty of confidentiality to patients and to other relevant third-party beneficiaries). 116 see also klitzman, supra note 114, at 75-116 (discussing disclosure of genetic disorders in families). 68 vol. 11:-1 disclosure of gamete donation duty towards the donor-conceived child to reveal genetic disorders that run in the family or to be tested for genetic disorders. such a proposition raises a few complexities. donors, like other genetic parents, often do not know the details of their genetic makeup," 7 especially with regard to rare genetic disorders that are recessive or with conditions that occur in adulthood (e.g., huntington's disease). concurrently, not everyone wants to know such information beforehand. it depends on personality, family and social circumstances, and, particularly in the united states, fear of discrimination in regard to employment or finding health and life insurance. 118 indeed, discrimination on the basis of one's genetic composition is a real possibility, despite the passage of gina.119 if access to the donor's medical and genetic data is thus framed as a right with parallel obligations on gamete donors to be tested, donors are worse off than traditional parents, and donor-conceived children are granted a power that naturally-conceived children do not have. that is, unless under this emerging universal "child's right to know," similar requirements of disclosure of medical and genetic data will be imposed on all parents and families. the construction of access to donors' and other genetic parents' medical and genetic information as a right further raises complicated questions of parental liability for genetic disorders that are hard-and, possibly, also socially wrong-to resolve. existing legal regulations absolve the genetic parents from responsibility towards the child. these regulations were crafted to protect the privacy of both gamete donors and donor-conceived-families once donation and conception, respectively, were accomplished. changing 117 a distinction in this context between genetic disorders and infectious diseases is in place. with regard to genetic disorders, there are some real questions as to the extent to which one knows about them for reasons i describe above; with regards to infectious diseases such as hiv/aids, on the other hand, there is greater room for expectation that one who was engaged in unsafe sex, drug use, etc "should have known" about the disease. 118 klitzman, supra note 114, at 37-47. 119 anya prince, genetic testing:7 a new civil rights frontier, ability magazine, oct.-nov. 2012, at 56-57. 2014 69 indiana health law review these regulations to allow for gamete donor liability because of genetic disorders, and regardless of the donor's knowledge thereof,120 would shatter this delicate balance. the notion of a right suggests a corresponding duty on the donor that raises the risk that gamete donors and, subsequently, all other parents will be seen as liable for any genetic disorders they may pass along to the child. in return, this opens the possibility that both naturally and donor-conceived children can make legal claims against their parents. under such claims, the duty of the medical profession to beneficence and non-maleficence is extended to parents.121 it suggests that parents have a duty to prevent harmful conditions in their child, including a predisposition to genetic disease, and that children born with genetic disorders can file suit against their parents for failing to fulfill this duty. while courts have so far generally refrained from accepting such cases, demanding liability from gamete donors may give these claims new impetus. some scholars have addressed this issue as a philosophical matter. jeffrey p. kahn, for instance, argues that the general principle of "do no harm" obligates parents to prevent harmful conditions in their child, including a predisposition to genetic diseases that would bring about the child's suffering either at birth or later on in life.122 others suggest that parents can -and have a moral duty to -choose a child without a disability as long as this choice does not risk them not having a child at all.12 3 still others 120 if the donor purposefully conceals a known genetic disorder, liability may be in place-not as a matter of parental duty, however, but because of signing a donation contract not in good faith. see also your legal responsibilities as a sperm, egg, or embryo donor, human fertilisation and embryology authority, http://www.hfea.gov.uk/ 1972.html#7204 (last updated aug. 8, 2012) (stating that under u.k. law, donor-conceived children can sue donors for knowingly concealing a genetic disorder from the fertility clinic). and in california, it is a felony for a person who knows he has hiv or aids to donate sperm. pi, supra note 32, at 384. 121 sabatello, children's bioethics, supra note 83, at 235. 122 jeffrey p. kahn, genetic harm: bitten by the body that keeps you., 5 bioethics 289, 303-06 (1991). 123 richard j. hull, cheap listening? reflections on the concept of wrongful disability, 20 bioethics 55, 59 (2006). 70 vol. 11:1 disclosure of.gamete donation resort to the so-called "non-identity problem" to dismiss the notion of liability on the basis of the child's disability. this argument suggests, "as long as the parental intervention does not produce a child whose 'life is not worth living,' we cannot say the child has been harmed (i.e., that this child is worse off) because a disabled life is better than no life at all."124 this is not a mere philosophical debate, however. on the one hand, to suggest that a child who was harmed will have no legal recourse because he or she would not have otherwise existed not only sets very low the standard of harm,125 but it also seems dismissive of the existing children who believe they were harmed. on the other hand, the suggestion that any arguable parental moral obligation can and should be translated into the child's legal right needs to be taken with caution. disability is a natural phenomenon; it is part and parcel of human fabric, and, in fact, notwithstanding the sensational media reports, there is no study showing that the rate of donor-conceived children with disabilities is any higher than it is in the general population nor is it at all clear how many instances of unknown incest relations following gamete donation actually materialized into a child with disabilities. creating a child's right to be "disability free" is therefore problematic not only as a matter of fact but also on social grounds. it looks at procreation merely as a matter of individual rights parental or child but ignores the interdependency among bearer of rights, especially in the context of reproduction and family relations. it lays down unreasonable expectations for parents, whose decision to procreate or to abort the fetus should be a personal choice. it also sends the wrong message that life with disabilities is not worth living, and it is likely to exacerbate, rather than reduce, the 124 i. glenn cohen, intentional diminishment, the non-identity problem, and legal liability, 60 hastings l.j. 347 (2008); see also in the context of gamete donor's anonymity, cohen, rethinking spermdonor anonymity, supra note 20, at 435. 125 kim m. mutcherson, in defense of future children: a response to cohen's beyond best interests, 96 minn. l. rev. headnotes 55-56 (2012). 2014 71 indiana health law review already rampant discrimination against persons with disabilities. the situation differs when gamete banks and fertility clinics are held liable for any genetic disorders passed along by donors. as the mediators between recipient parents and donors whose business and main interest is profit, gamete banks and fertility clinics are responsible for ensuring that the product that they provide is safe, regardless of whether gamete donation should be viewed as commodity. certainly, caution is needed in this context as well. as many of the tests for various genetic disorders were only recently developed, it is very possible that these diagnostic capabilities were not available at the time of donation. further, it is too demanding to require gamete banks to screen all samples for every possible genetic disorder. 126 indeed, conventional genetic parents who choose to receive genetic counseling are tested only for the most common genetic disorders that may occur given their ethnic background and not for all possible rare disorders. even so, the option of stipulating clear legal requirements from fertility clinics is more responsive to the interests of all stakeholders. as the go-between for gamete donors, recipient parents, and, later on, the donor-conceived child, fertility clinics are in a position to both meet the interest of donor-conceived children to access the medical information about the donor while still upholding the donor's interest of privacy. in fact, this was also the solution provided in the case of johnson v. superior court of los angeles county in 2000, where a child conceived with donated sperm was diagnosed with a severe kidney disease called autosomal dominant polycystic kidney disease ("adpkd") that was traced back to the donor.127 126 rosas, supra note 32, at 413. 127 johnson v. super. ct., 95 cal. rptr. 2d 864 (app. 2000). in this case, the recipient parents along with their minor daughter brought fraud causes of action against cryobank and others alleging that they failed to disclose that the sperm donation they sold to them came from a donor with a history of this kidney disease. the question presented to the court was whether the plaintiffs can compel the donor's deposition and production of documents in order to discover information relevant to their action against cryobank. 72 vol. 11:1 disclosure of gamete donation recognizing the legitimate privacy interests of the sperm donor, the court ruled that while the fertility clinic, california cryobank, inc., ("cryobank") has to provide the medical data relevant to the case at stake, the donor's "identity is to be protected to the fullest extent possible and the identities of his family members are not to be disclosed." put differently, there is no reason why a separation between the responsibility of fertility clinics to record, preserve, and provide medical data about the donor, including follow up with donors when necessary, and the anonymity of the donor in respect with the recipient parents and the donorconceived child cannot be clearly established in law. in this way both the privacy interest of the gamete donor and the interest, but not right, of donor-conceived children in accessing the donor's medical information are being upheld; the legal requirement of disclosure merely preventing fertility clinics-the only party who is in this field for the purpose of financial profit-from hiding behind the veil of donors' anonymity for their financial gain. the shift towards the responsibility of gamete banks and fertility clinics-and the subsequent need to regulate access to the medical information of gamete donors' in the united states-is further strengthened when more systematic deficiencies in medical practice in the united states are considered. specifically, two such deficiencies should be mentioned. the first is that although genetic counseling and existing technologies in the field of genetics are often sufficient to diagnose donor-conceived children with known genetic disorders, to determine consanguine relationships, and to avoid the transmission of a disorder to the next generation through pre-implantation genetic diagnosis on the basis on one's genetic composition alone, such diagnoses are often missed. this is especially so with regard to rare genetic diseases, as primary healthcare providers often lack sufficient knowledge and awareness about the prognoses and testing of such diseases. 128 this is true also for fertility clinics. reports show that when they receive information 128 klitzman, supra note 114, at 34-37. 2014 73 indiana health law review about medical symptoms experienced by a donor-conceived child, they often fail to tie it to the donor and to take necessary steps to avoid the further use of the donor's gamete.129 this barrier is further exacerbated in the united states as its private healthcare system, unique among its western counterparts, operates on referrals to specialists rather than on the appropriate training of primary care providers. additionally, unlike other countries that provide national healthcare, the private insurance companies in the united states may refuse to cover the associated costs of this testing, and, indeed, they do so commonly.130 even though many of these insurance decisions are eventually reversed upon appeal,1'1 much time and money is wasted before the donor-conceived child is diagnosed and treated. it is also for this reason that developments in "personalized medicine," where the "one size fits all" model of medical treatment shifts towards one that "tailors prediction, diagnosis and treatment to the individual,"132 may not necessary yield any better results. this form of medicine still requires highly qualified physicians who are invested in the individual and receptive insurance companies who will cover the bills. second, in the united states, the effort to receive a genetic diagnosis that can be traced to the gamete donor is in many ways tied with the question of fertility clinics' accountability. as the gate-keepers of information about gamete donors, fertility clinics who failed to properly follow up on information about genetic disorders or other medical conditions of the donor and his or her family can, and have, argued that donors' anonymity prevents them from 129 see ayesha ahmad, danish sperm donation law tightened after donor passes on rare genetic disease, bionews (oct. 1, 2012), http://www.bionews.org.uk/page_186023.asp; rosas, supra note 32, at 394-96. 130 klitzman, supra note 114, at 34-37. 131 united states government accountability office, no. gao-11-68, private health insurance: data on application and coverage denials 16-26 (2011), available at http://www.gao.gov/new. items/d11268.pdf. 132 richard tutton, personalizing medicine: futures present and past, 75 soc. scl. & med. 1721 (2012). vol. 11:174 disclosure of gamete donation providing such information to recipient parents. the ability of fertility clinics to evade responsibility is further exacerbated by the lack of comprehensive requirements to preserve the medical information of the gamete donor or to enable follow up with donors who may have passed along genetic disorders. they may simply argue that this information is no longer available. in the lack of national single-payer healthcare or a no-fault system for compensation for medical injuries as exist, for instance, in various scandinavian countries such as sweden, individuals are more likely to sue clinics for negligence to recover the mounting costs. indeed, in the only case in the united states revolving around disclosure of gamete donation for medical reasons, the issue at stake was the fertility clinic's effort to conceal its knowledge about the donor's genetic disorder during the subsequent medical malpractice suit.133 these deficiencies in medical practice will not disappear under the patient protection and affordable care act ("aca").134 the aca extends the group of persons eligible to apply for healthcare insurance including especially those with pre-existing conditions and creates more incentives for insurances to cover the uninsured through the so-called exchange program that requires coverage of essential health benefits to be determined by the government. it does not, 13s johnson v. super. ct., 95 cal. rptr. 2d 864 (app. 2000). disturbingly in this case, however, the superior court of los angeles county ultimately denied the request of the recipient parents and the donor-conceived child that she is entitled to recover general damages or damages for lost earnings. the court stated, "regardless of what petitioners allege with respect to causation, it cannot be said that cryobank, sims and rothman caused brittany's [the child] inherited abnormalities by improperly approving donor no. 276 as a sperm donor. brittany's kidney condition was caused by the gene contained within the sperm provided by donor no. 276." the court thus determined that this request was justly classified by the trial court as a wrongful life case, and that its decision was bound by the decision of the california supreme court in turpin v. sortini, 643 p.2d 954 (cal. 1982) (denying entitlement to recover general damages or damages for lost earnings for a child who was born deaf due to medical malpractice). 134 patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010) (codified as amended in scattered sections of 21, 25, 26, 29, and 42 u.s.c.). 2014 75 indiana health law review however, change the process of insurance decision-making about which treatments are considered medical necessitya threshold for coverage also within the range of those essential health benefits-hence potentially leaving the number of denial of benefits unchanged. the aca also does not change the fault-based, adversarial system that exists in the united states, and, overall, it is unlikely to reform the system of delivering healthcare services in the united states so that it resembles the situation in other countries that provide national healthcare to all. establishing clear medical screenings of potential donors; requiring due diligence from fertility clinics; reexamining existing samples for genetic disorders; follow up with gamete donors to see if they develop disease later when there is an indication, in light of the medical condition of the donor-conceived-child, for possible genetic disorder; and similar measures are thus justified to rectify deficiencies in medical practice, especially in the united states, that significantly impact donor-conceived children. this remains the case even though the number of donorconceived children who are born with genetic disorders, or disabilities generally, is unknown, as is whether this figure exceeds the rate of children born with genetic disorders and disabilities in the general population. as the medical profession and fertility clinics have failed to properly address this issue on their own, the government's use of its parens patria powers is thus grounded in the protection of donor-conceived children who had no say about whether or not they will be born. to be sure, regulating how gamete banks and fertility clinics handle donated gametes will not solve all the dilemmas that arise. one such complex issue is the question of disclosure of genetic disorders. for instance, it is questionable whether young donor-conceived children (as other children-and in fact, also adults) want and can cope with information about one's genetic composition, particularly if they are asymptomatic and given the possible negative repercussions if genetic disorders are diagnosed. the scope of the duty to disclose the donor's genetic disorder is also not as straightforward as it may seem. for instance, vol. 11:176 disclosure of gamete donation if a donor-conceived child is diagnosed with a genetic disorder that can be attributed to the donor, should gamete banks and fertility clinics contact all donor-conceived children from that donor, including asymptomatic ones, to inform them about the disorder? moreover, the extent to which it is possible to protect donor-conceived children in particular from being unintentionally forced to face disclosure of their potential genetic disorders should be considered. with the rise of internet communication, recipient parents or donor-conceived children may post information on online listserves for donor-conceived families about the diagnosis of genetic disorders, thus in effect informing other recipient parents and donor-conceived siblings whom they have never met or have met merely through the online forum about their own possible genetic composition. this is troubling given that the meaning of such information may be unclear and inaccurate, especially if provided by people who are not experts in the field, and, moreover, it is also potentially emotionally devastating. studies on these questions are essential to determine the ethical and legal standards that should apply. what this discussion illustrates is that the distinction between the goal of a donor's medical surveillance and the child's right to know needs to be clarified. as a matter of public health policy, the collection of the donor's medical data is critical. the donor chose to donate gametes; the subsequent collection of medical information, therefore, cannot be regarded as too invasive to his or her right to privacy. as fertility clinics are the most direct mediators of the interests of the various stakeholders in this process, regulating their work is within the legitimate scope of the governmental use power. as the prime bodies who are in the business of making babies and money, they should be held to higher standards of due diligence in their work. yet, the importance of the collection of medical information and its disclosure cannot, and should not, be automatically translated into a right of donor-conceived children to demand that other identifying information be provided to them. access to medical information as an interest should be separated from a discussion about rights, where a true 2014 77 indiana health law review balancing between the arguable rights of recipient parents, gamete donors and donor-conceived-children is practically impossible. vi. conclusion my challenges to disclosure proponents' arguments do not intend to deny that donor-conceived children have an interest in accessing information relating to their donors or to dismiss the frustration they feel when such information is unavailable to them. it is also not intended to endorse family secrets especially in the context of health and reproduction as a preferable option. rather, my criticism lies in the implied universality of proponents' claims, particularly given that only limited data exist and almost none of that which pertains to the united states. moreover, classifying disclosure of one's circumstances of conception and of gamete donor's information as a right is problematic. not every interest one has-as valuable as it may be-can or should be translated into a right. a right should have a moral foundation; it should be universally applicable and empowering, its exercise free from complete control of others. current discussions of the context of disclosure of gamete donation and the child's right to know do not follow these requirements. in short, an interest in a donor's medical and genetic data does not necessarily extend to the provision of other identifying information; it also raises serious questions about the scope of genetic screening, healthcare insurance, and other relevant responsibilities associated with disclosure. as discussed, the claim that all donor-conceived children share a similar interest in disclosure is dubious; it is moreover unclear what role the donor-conceived family structure plays in this interest. religious and other cultural considerations also play pivotal roles in parental decisions to disclose the circumstances of conception to their children, and ignoring these considerations may lead to serious social consequences for all involved. the broader implications of a universal right to know requires balancing the interests of donor-conceived 78 vol. 11:1 disclosure of gamete donation children, donors, and recipient parents; additional debate and study of the role of the state; and clearer understanding of the interplay between law, multiculturalism, western liberalism, and truth-telling in family relations. whether donor-conceived children want to know, if it is in their best interest, and who decides are all critical questions. clearly, further research is needed. the views of donor-conceived children from various familial, ethnic, and religious backgrounds, including, in particular, donorconceived children who do not know, are crucial. this is especially the case with data based in the united states, which, ironically, can only be collected and improved if the field is regulated. given the united state's private healthcare system, preference for non-interventionist governance and predilection for a free market, the implications of disclosure differ significantly from those in other countries that reversed the policy of donors' anonymity. all of these issues need to be carefully considered if viable policies are to be achieved. conceptualizing access to information about one's genetic origin as a right is also erroneous. it positions disclosure as the primary, possibly sole, factor necessary for donor-conceived children and families to prosper and thrive. in no other context is truth-telling granted such absolute power without proper, unbiased studies that justify interference. stipulating a right to know one's genetic sources that is entirely dependent on others for its implementation is insufficient, and adopting measures to ensure one's ability to independently exercise it is essential. moreover, if disclosure is paramount-indeed, a right-it should extend to all children who do not know their story of conception or the identities of their parents. as measures akin to an active registry and imposed genetic testing at birth-measures that undoubtedly stand in stark contrast with the united states principle of privacy and noninterference approach-are not likely to find many supporters, setting appropriate regulations on the work of fertility clinics in performing reproduction through gamete donation would yield better results. 2014 79 indiana health law review gamete donation regulations that focus on fertility banks and clinics can address the most urgent need in this field, that is: the protection and assistance to donorconceived children who are diagnosed or in the process of being diagnosed with genetic disorders. such regulations should require fertility banks and clinics to establish clear medical screenings of potential donors and to record appropriate information about gamete donors so as to allow also for follow-ups and the reexamination of samples for genetic disorders when there is indication for a possible genetic disorder such regulations would also respond to deficiencies in medical practice, which are exacerbated in the united states where the private healthcare system and the need to resort to courts are both unique. simultaneously, allowing the parents the choice of whether to disclose the gamete donation or to keep it a secret is in line with the united states' social and cultural traditions of familial privacy. this is the case even though encouragement of parental disclosure may be promoted (but not imposed). the aforementioned discussion and the recommendations for gamete donation regulations for medical purposes are not set in stone. as a social phenomenon, the field of gamete donation is continuously developing, and in the future, other adjustments and changes might be in place. with the possibility of follow up, fertility clinics and banks might find that donors are not as averse to disclosure of their non-identifying and even identifying information as historically been the case. the availability of information about gamete donors might play a role in the recipient parents' decision to disclose the gamete donation to the donor-conceived child. the availability of such information might additionally reduce the anxiety of some donor-conceived children who know about their circumstances of conception-even if they choose not to access it. then again, another possible development might be that the more society accepts nontraditional, social and non-genetic families and moves towards personalized medicine, the less appealing information about gamete donors would be for donor80 vol. 11:1 2014 disclosure of gamete donation 81 conceived children who, in actuality, might have very little in common with the gamete donor. indeed, ultimately, the solution for complexities arising in the context of gamete donation should be tailored to the needs of specific societies and responsive to the interests of all stakeholders involved. indiana health law review volume xvi 2018 number 1 articles the false claims act and the escobar decision: what is on the horizon for the healthcare industry natasha boyadzieva* i. introduction the federally funded medicare and medicaid health care programs are subject to fraud and abuse by various health care entities due to the opportunity for the entities to receive a great payout. the payout has been expanding over the years and is projected to grow, making the health care system an attractive target for fraud and abuse.1 the false claims act (“fca”) is the primary tool for combating such fraud and abuse.2 in effect, fca provides remedies to the government and individuals, including consumers and taxpayers.3 the fca statute enables the federal government to recover billions of dollars that are lost due to fraudulent activities. in the fiscal year 2017, the government recovered * natasha boyadzieva is an attorney practicing in california. ms. boyadzieva graduated in 2017 with her j.d. with honors degree from the george washington university law school. she would like to thank her family, friends, and the editors of the indiana health law review for their support and guidance. 1. national health expenditure data fact sheet, ctrs. for medicare & medicaid servs., https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andreports/nationalhealthexpenddata/nhe-fact-sheet.html [http://perma.cc/76jq-yfhv] (last modified apr. 17, 2018); see also health care, projections for major health care programs for fy 2018, cong. budget off., https://www.cbo.gov/topics/health-care [http://perma.cc/373p-7bwa]; juliette cubanski & tricia neuman, the facts on medicare spending and financing, kaiser fam. found. (june 22, 2018), http://kff.org/medicare/fact-sheet/medicare-spending-and-financing-factsheet/ [http://perma.cc/t59p-mqlc]. 2. false claims act (fca), 31 u.s.c. §§ 3729–33 (2012). besides civil fca provisions, there are also criminal ones (18 u.s.c. §287 (2012)) that are not the focus of this article. additionally, twenty-nine states and d.c. have enacted their own civil fca provisions similar to the federal fca. see, e.g., la. stat. ann. §438.3 (2018). 3. see generally taxpayers against fraud, www.taf.org [https://perma.cc/7sehm8ql]; the health care fraud and abuse control program protects consumers and taxpayers by combating health care fraud, ctrs. for medicare & medicaid servs. (jan. 18, 2017), https://www.cms.gov/newsroom/mediareleasedatabase/fact-sheets/2017-fact-sheet-items/201701-18-2.html [https://perma.cc/qxp3-4wzz]. http://doi.org/10.18060/3911.0052 2 indiana health law review [vol. 16:1 $2.4 billion as a result of health care fraud judgments, settlements and additional administrative impositions in health care fraud cases and proceedings.4 in 2016, over $3.3 billion was returned to the federal government or paid to private persons.5 the recovered amount represents only a fraction of the actual fraud.6 for many years the lower courts did not demonstrate consistency when deciding under which legal theory fca claims could be brought. some lower courts recognized only the express theory of certification. in 2016, the supreme court’s escobar decision emerged with recognizing the implied certification theory. this article addresses the fca in wake of the escobar decision as well as the implications the decision has on future cases. section ii provides an overview of fca, distinguishes it from medical malpractice, and points to the variations that existed in the lower courts. section iii states the relevant facts and legal issues in escobar. further, section iv discusses the decision, addresses the way escobar redefined the existing judicial tests for assessing materiality, and discusses ways in which escobar opened the door for future prosecution and defense. section v contains additional pleading issues that must be considered. finally, section vi concludes by offering some guidance on what escobar changed as well as what it left unaffected in relation to the fca enforcement. potential effects that could be observed in the lower courts, as a result of escobar, are also stated. ii. fca overview the fca prohibits any person from knowingly submitting a false or fraudulent claim to the united states for payment or approval or knowingly making any false statement material to such a false or fraudulent claim.7 the attorney general may bring actions directly in the name of the united states.8 alternatively, a relator—private person also known as whistleblower—may bring a qui tam action for the person and for the u.s. government.9 if the action brought prevails, the relator would share a portion of the damages received with 4. u.s. dep’t of health & human servs. & dep’t of justice, health care fraud and abuse control program annual report for fiscal year 2017, at 1 (2018), https://oig.hhs. gov/publications/docs/hcfac/fy2017-hcfac.pdf [http://perma.cc/5xe7-uch3]. 5. u.s. dep’t of health & human servs. & dep’t of justice, health care fraud and abuse control program annual report for fiscal year 2016, at 1 (2017), https://oig.hhs.gov/publications/docs/hcfac/fy2016-hcfac.pdf [http://perma.cc/5nl9-sngd]. 6. see, e.g., financial crimes report to the public: fiscal year 2010-2011, fbi, https:/ /www.fbi.gov/stats-services/publications/financial-crimes-report-2010-2011 [http://perma.cc/xg26-d78k] (reports by the federal bureau of investigation estimate that “fraudulent billings to health care programs, both public and private, [represent] between 3 and 10 percent of total health care expenditures.”). 7. 31 u.s.c. § 3729(a) (2009). 8. 31 u.s.c. § 3730(a) (2012). 9. 31 u.s.c. § 3730 (2012). 2018] the false claims act and the escobar decision 3 the government.10 however, fca is not designed to reach every kind of fraud practiced on the government.11 it does not encompass regulatory noncompliance that is irrelevant to the government’s disbursement decision.12 a plaintiff, in violation under section 3729(a)(1) must prove that “(1) the defendant presented or caused to be presented to an agent of the united states a claim for payment; (2) the claim was false or fraudulent; and (3) the defendant knew the claim was false or fraudulent.”13 pointing to a specific claim deemed to be false is significant because the theory of the fca violation is grounded primarily in identifying the false claim submission(s). further, the requisite intent is the knowing presentation, thus the violation would not be actionable under the fca unless it is knowingly committed. as defined by congress, the terms “knowing” and “knowingly” besides actual knowledge also include deliberate ignorance or reckless disregard of the truth or falsity of the information.14 innocent mistakes or negligent conduct are not equivalent to reckless disregard.15 further, if the defendant’s interpretation of the applicable regulations is reasonable, although incorrect, the element of knowingly is not satisfied.16 moreover, the false claim must be material, highlighting that it must have a “natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.”17 for example, a violation of certification of compliance with regulations could not be material if the government is aware of the violation but continues to pay anyways.18 even if unknown to the government, not all noncompliance and violations are material because “to 10. 31 u.s.c. § 3730(d)(1)-(2) (2012). 11. united states v. mcninch, 356 u.s. 595 (1958). 12. united states ex rel. mikes v. straus, 274 f.3d 687 (2d cir. 2001). 13. hutchins v. wilentz, 253 f.3d 176, 182 (3d cir. 2001) (paraphrasing 31 u.s.c. § 3729(a)(1)). 14. 31 u.s.c. § 3729(b)(1)(a) (2012). 15. congress added “reckless disregard” or “deliberate ignorance” to fca in 1986. see false claims amendments act of 1986, pub. l. no. 99-562, 100 stat. 3153 (1986). the senate report that accompanied the change evinced an intent to hold liable “only those who act in gross negligence,” who failed “to make such inquiry as would be reasonable and prudent to conduct under the circumstances.” s. rep. no. 99–345, at 20 (1986). see also hindo v. univ. of health scis., 65 f.3d 608, 613 (7th cir.1995) (stating that negligence is not actionable). 16. united states ex rel. kersulis v. rehabcare grp., inc., 2007 wl 294122 (e.d. ark. jan. 29, 2007) (holding that summary judgment was appropriate for the defendants because cms did not provide any formal guidance regarding the interpretation of the relevant but unclear fca regulations, and there was no evidence to show that the hospital knowingly provided false information or caused false claims to be submitted to the federal government). 17. 31 u.s.c. § 3729(b)(4) (2012) (emphasis added). 18. united states ex rel. stephenson v. archer w. contractors, l.l.c., 548 f. app’x 135, 138 (5th cir. 2013) (defendant provided emails that the government knew the trucks were overweight. the court wondered “[h]ow could such ‘fraud’ be material to payment if the defrauded party knows about it and remains satisfied with the work?”). 4 indiana health law review [vol. 16:1 construe the implied false certification theory in an expansive fashion would improperly broaden the act’s reach.”19 in 2009, the fca amendments stipulated that materiality should be judged objectively focusing on what the impact would be on a “reasonable” agency rather than judging subjectively, and requiring the plaintiff to show an actual effect on the government’s decision to pay.20 the 2009 amendments are seen as expanding the original fca provisions since liability may attach to claims that are submitted to a “contractor, grantee, or other recipient” of federal funds, regardless of whether a false claim was submitted directly to the government.21 in addition to overturning judicial precedents,22 the amendments provided explicit materiality requirement—“knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.”23 generally, the primary purpose of the fca “is to indemnify the governmentthrough its restitutionary penalty provisions-against losses caused by a defendant’s fraud.”24 notably, the civil fca provisions include heavy penalties and treble damages.25 the incentive for a relator to bring an fca claim can also be viewed as huge. for instance, if the government declines to intervene in an action, the relator may proceed independently and be awarded a “reasonable amount”—between 25 and 30 percent—of any proceeds or settlement, along with reasonable costs and attorney’s fees.26 moreover, fca is significant as many fca violations implicate prohibited activity and penalties under other laws, such as the anti-kickback statute or stark law.27 the legal consequences that might 19. united states ex rel. mikes v. straus, 274 f.3d 687 (2d cir. 2001). see also united states ex rel. milam v. regents of the univ. of cal., 912 f. supp. 868 (d. md. 1995) (granting summary judgment for defendants when the plaintiff argued that the defendants’ research was false because it was not conducted in accordance with the scientific method). 20. see fraud enforcement and recovery act of 2009, pub. l. no. 111-21, § 4(a), 123 stat. 1617, 1621 (2009). see also s. rep. no. 111-10, at 4 (2009) (“the effectiveness of the false claims act has recently been undermined by court decisions which limit the scope of the law and, in some cases, allow subcontractors paid with government money to escape responsibility for proven frauds.”) 21. §4(a), 123 stat. at 1623. congress also removed the requirement that a subcontractor act with the specific intent “to get” a false claim paid “by the government.” s. rep. no. 111-10, at 12. as a consequence, it is no longer necessary that an individual or entity act with the specific intent to defraud the government. 22. allison engine co. v. united states ex rel. sanders, 553 u.s. 662 (2008); united states ex rel. totten v. bombardier corp., 380 f.3d 488 (d.c. cir. 2004). 23. 31 u.s.c. § 3729(a)(1)(b) (2012) (emphasis added). 24. united states ex rel. taylor v. gabelli, 345 f. supp. 2d 313, 331 (s.d.n.y. 2004). 25. 31 u.s.c. § 3729(a)(1)(g) (providing that the penalties range from $5,000 to $10,000, “plus 3 times the amount of damages which the government sustains”). 26. § 3730(d)(2). 27. see anti-kickback statute, 42 u.s.c. § 1320a-7b; stark law, 42 u.s.c. § 1395nn (promulgating regulations at c.f.r. §§ 411.350-411.389); see also ebeid ex rel. united states v. lungwitz, 616 f.3d 993, 998 (9th cir. 2010) (stating that stark law and the medicare regulations 2018] the false claims act and the escobar decision 5 follow if fca liability attaches are some of the reasons that congress’ language and intent need to be enforced with great precision. if allowed to proceed forward, baseless suits targeting conduct outside of the fca’s purpose and scope, would also exhaust judicial resources. a. fca framework: falsity initially, fca raises several complex issues regarding the meaning and the scope of a false claim since congress did not define the terms false or fraudulent. while lower courts have attempted to clarify the meaning on numerous occasions, the supreme court has stated that absent other indication, common law terms of fraud should be incorporated.28 the aspect that must be underlined is the required objective falsehood. recently, united states v. aseracare,29 the government argued that medical records of 123 patients did “not contain ‘clinical information and other documentation that support[ed aseracare’s] medical prognosis,’ and thus, aseracare’s claims for those patients were ‘false.’”30 the court granted summary judgment for aseracare holding that an opinion of one medical expert alone is insufficient to support an fca claim alleging false certification of patient eligibility for medicare hospice benefits.31 the court emphasized that “[w]hen hospice certifying physicians and medical experts look at the very same medical records and disagree about whether the medical records support hospice eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.”32 the court was “concerned that allowing a mere difference of opinion among physicians alone to prove falsity would totally eradicate the clinical judgment required of the certifying physicians.”33 consistent with aseracare, recently in united states ex rel. polukoff v. st. mark’s hospital,34 a district court dismissed the relator’s complaint and denied a leave to amend after determining that the relator could not “identify an objectively false representation made by any of the defendants.”35 the relator’s “allegations [were] based on subjective medical opinions that cannot be proven could form the basis for an fca suit if pled properly). 28. sekhar v. united states, 570 u. s. 729 (2013); see also neder v. united states, 527 u.s. 1, 22 (1999) (explaining that the term “actionable ‘fraud’” is one with “a well-settled meaning at common law”). 29. united states v. aseracare, inc., 176 f. supp. 3d 1282 (n.d. ala. 2016) (granting summary judgment for the defendant). 30. id. at 1283. 31. id. at 1286. 32. id. at 1283. 33. id. at 1285. see also united states ex rel. phalp v. lincare holdings, inc., 116 f. supp. 3d 1326, 1360 (s.d. fla. 2015) (“expressions of opinion, scientific judgments, or statements as to conclusions about which reasonable minds may differ cannot be false.”). 34. united states ex rel. polukoff v. st. mark’s hosp., 2017 wl 237615 (d. utah, jan. 17, 2017). 35. id. at *11. 6 indiana health law review [vol. 16:1 to be objectively false.”36 overall, the case law is clear and consistent: “the submission of a false claim is the sine qua non of [an fca] violation.”37 b. distinguishing fca from medical malpractice fca must first be distinguished from medical malpractice. “medical malpractice is defined as any act or omission [done] by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient.”38 fca can be used against providers who provide substandard health care that harms patients when systemic, egregious violations are implicated.39 sanctions under the fca are appropriate only if dereliction has “occurred in a substantial number of cases or the violation [is] especially gross and fragrant…rather than an individual incident of noncompliance.”40 for example, in some cases the health care entity exists for no other purpose than to financially defraud the government. unlike medical malpractice, fca has the scienter requirement of intentional misrepresentation that extends to encompass gross negligence or reckless disregard but not negligence alone.41 furthermore, many health and safety matters are of local concern and are left in the purview of the individual state legislation; they are not appropriate for imposing the federal fca liability.42 c. false certification theory: express and implied certification there are two categories of false claims under the fca: a factually false claim and a legally false claim.43 a claim is factually false when the claimant misrepresents what goods or services it provided to the government while a claim is legally false when the claimant knowingly falsely certifies that it has complied with a statute or regulation the compliance with which is a condition for 36. id. at *9. 37. urquilla-diaz v. kaplan univ., 780 f.3d 1039, 1052 (11th cir. 2015) (citation omitted). 38. b. sonny bal, an introduction to medical malpractice in the united states, 467 clinical orthopaedics & related res. 339, 340 (2009), https://www.ncbi.nlm.nih.gov/ pmc/articles/pmc2628513/pdf/11999_2008_article_636.pdf [https://perma.cc/awa4-pazr]. 39. see united states ex rel. mikes v. straus, 274 f.3d 687 (2nd cir. 2001). 40. id. at 702. 41. 31 u.s.c. § 3729(b)(1)(a) (2018). see also false claims amendments act of 1986, pub. l. no. 99-562, 100 stat. 3153 (1986). 42. michael m. mustokoffet al., the government’s use of the civil false claims act to enforce standards of quality of care: ingenuity or the heavy hand of the 800-pound gorilla, 6 annals health l. 137, 137 (1997), https://pdfs.semanticscholar.org/7d6c/30c7a350c087 10668eb789a2fac20ad62400.pdf [https://perma.cc/4ugd-h4mg] (stating that allowing fca to be used in that way was not “an ingenious exercise of federal power,” but was like “the heavy hand of the 800-pound gorilla”). 43. united states ex rel. conner v. salina reg’l health ctr., inc., 543 f.3d 1211, 1217 (10th cir. 2008) (citing united states ex rel. mikes v. straus, 274 f.3d 687, 695-96 (2d cir. 2001)). 2018] the false claims act and the escobar decision 7 government payment.44 a legally false fca claim is based on the “false certification” theory of liability45 and it is the main focus of this paper. prior to 2016, some courts recognized two types of false certifications: 1) express and 2) implied.46 under the “express false certification” theory, an entity is liable under fca for falsely certifying that it complies with regulations that are prerequisites to government payment in connection with the claim for payment of federal funds.47 there is also an expansive version of the false certification theory called “implied false certification” where liability attaches when a claimant seeks and makes a claim for “payment from the government without disclosing that it violated regulations that affected its eligibility for payment.”48 thus, an implied false certification theory of liability is premised “on the notion that the act of submitting a claim for reimbursement itself implies compliance with governing federal rules that are precondition to payment.”49 “[s]upport for the implied theory [is] found in the congress’ expressly stated purpose that the act include at least some kinds of legally false claims…and in the supreme court’s admonition that the act intends to reach all forms of fraud that might cause financial loss to the government.”50 however, the implied theory did not gain nationwide recognition; the theory was raised repeatedly as basis for liability and defendants in some jurisdictions were successful in challenging it. d. decisions from lower courts prior to escobar until 2016, whether a complaint could survive a motion to dismiss challenge51 depended on whether a specific jurisdiction recognized the two theories of liability or only the express one. many circuits permitted fca claims to proceed under an implied certification theory. united states ex rel. mikes v. straus,52 is a leading case recognizing implied certification as a basis for liability under the fca. however, the second circuit stated that the implied theory should have limited application only in cases where compliance with specific regulations 44. id. 45. see rodriguez v. our lady of lourdes med. ctr., 552 f.3d 297, 303 (3d cir. 2008) (overruled in part on other grounds by united states ex rel. eisenstein v. city of new york, 556 u.s. 928 (2009)). 46. see, e.g., conner, 543 f.3d at 1217; mustokoff et al., supra note 42. 47. rodriguez, 552 f.3d at 303. 48. id. 49. mikes, 274 f.3d at 699; see also united states v. sci. applications int’l corp., 626 f.3d 1257, 1266 (d.c. cir. 2010) (“courts infer implied certifications from silence where certification was a prerequisite to the government action sought.”). 50. mikes, 274 f.3d at 699; see also united states v. neifert-white co., 390 u.s. 228, 232 (1968). 51. fed. r. civ. p. 12(b)(6). a party may assert the following defense by motion: failure to state a claim upon which relief can be granted. 52. mikes, 274 f.3d at 687. 8 indiana health law review [vol. 16:1 or laws was condition to payment.53 in united states ex rel. wilkins v. united health group, inc.,54 the third circuit stated that to plead a claim for relief under an implied certification theory, it is required to allege that the “defendants submitted claims for payment to the government at a time that they knowingly violated a law, rule, or regulation which was a condition for receiving payment from the government.”55 additionally, the tenth circuit explained the difference between conditions of participation and conditions of payment: “conditions of participation…are enforced through administrative mechanisms, and the ultimate sanction for violation of such conditions is removal from the government program,” while conditions of payment are those which, “if the government knew they were not being followed, might cause it to actually refuse payment.”56 many courts followed this distinction.57 however, some conditions of eligibility could be viewed as preconditions to payment, thus it is hard to completely separate the conditions of eligibility from conditions of payment.58 therefore, some courts did not draw lines because those categories “do more to obscure than clarify.”59 while many courts recognized the implied false certification liability,60 other courts rejected it. for example, the 53. united states ex rel. qazi v. bushwick united hous. dev. fund corp., 977 f. supp. 2d 235, 240 (2d cir. 2013) (holding that the fca action is dismissed since the alleged was a condition of participation violation and not conditions of payment, therefore the claim was not actionable); see also united states ex rel. blundell v. dialysis clinic, inc., 2011 u.s. dist. lexis 4862, at *56 (n.d.n.y. jan. 19, 2011). 54. united states ex rel. wilkins v. united health group, inc., 659 f.3d 295, 306 (3d cir. 2011). 55. id. at 313; see also ebeid ex rel. united states v. lungwitz, 616 f.3d 993, 998 (9th cir. 2010). 56. united states ex rel. conner v. salena reg’l ctr., inc., 543 f.3d 1211, 1220 (10th cir. 2008). 57. see, e.g., united states ex rel. wilkins v. united health group, inc., 659 f.3d 295 (3d cir. 2011); united states ex rel. parikh v. citizens med. ctr., 977 f. supp. 2d 654, 677 (s.d. tex. 2013) (holding that failure to comply with a mere condition of participation, rather than a condition of payment is inadequate for fca liability to attach. the court reasoned if contractual language could convert a condition of participation into a condition of payment, it would “drastically expand the role of the courts in policing regulations in an area traditionally governed by administrative agencies.”); united states ex rel. hobbs v. medquest assocs., inc., 711 f.3d 707 (6th cir. 2013). 58. united states ex rel. hendow v. univ. of phoenix, 461 f.3d 1166, 1176 (9th cir. 2006) (holding that a regulation may in some cases be both, a condition of payment and a condition of participation). 59. united states ex rel. hutcheson v. blackstone med., inc., 647 f.3d 377 (1st cir. 2011) (refusing to apply distinctions between factually false and legally false, as well as between express certification and implicit certification). 60. see united states ex rel. mikes v. straus, 274 f.3d 687, 699-700 (2d cir. 2001); united states ex rel. augustine v. century health servs., inc., 289 f.3d 409, 415 (6th cir. 2002); ebeid, 616 f.3d at 996-98; conner, 543 f.3d at 1217-18; but see hutcheson, 647 f.3d at 2018] the false claims act and the escobar decision 9 seventh circuit stated that only express (or affirmative) falsehoods could render a claim “false or fraudulent.”61 in 2016, the supreme court was presented with a unique opportunity62 to decide whether the implied theory could be a viable cause of action. the court aimed to achieve uniformity on a matter that was dividing the lower courts. consistency across the country was required particularly because an enforcement of a federal law with potentially significant penalties was at issue. the supreme court provided guidance on some of the most critical fca aspects.63 iii. universal health services inc. v. united states ex rel. escobar the case came to the supreme court to resolve a circuit split regarding the use of implied certification theory as a basis for asserting that certain claims are false.64 the court focused on whether the theory would be recognized or not as a cause of action, without addressing the merits of the case. therefore, the decision was whether access to the courts would be granted or precluded. yet, it impacted the applicable substantive law since whether the merits were reachable or not depended on the court’s recognition of the implied certification theory. in escobar, it was alleged that arbour, a mental health treatment facility and subsidiary of universal, “knowingly misrepresented its compliance with requirements central to the mental health counseling, [which medicaid] would have refused to pay…had it known of these violations.”65 both sides disagreed if “submitting a claim without disclosing violations of statutory, regulatory, or contractual requirements constitutes…an actionable misrepresentation.”66 the relators and the government argued that submitting a claim for payment means “implicitly represent[ing] that the claimant is legally entitled to payment, and that failing to disclose violations of material legal requirements [makes] the claim misleading.”67 on contrary, universal, as defendant, argued “that submitting a claim involves no [representation]…nondisclosure of legal violations is not actionable absent a special duty…to exercise reasonable care to disclose the matter in question….”68 the district court granted a motion to dismiss, thus initially the 12(b)(6) 380 (declining to employ judicially created categories of express and implied false certification); harrison v. westinghouse savannah river co., 176 f.3d 776, 786 n.8 (4th cir. 1999) (without addressing validity of implied false certification theory, stating that its precedent makes the theory “questionable”). 61. united states v. sanford-brown, ltd., 788 f. 3d 696, 711-12 (7th cir. 2015). 62. universal health servs. inc. v. united states ex rel. escobar, 136 s. ct. 1989 (2016). 63. see id. 64. id. at 1998. 65. id. at 1993. 66. id. at 1999. 67. id. at 2000. 68. id. 10 indiana health law review [vol. 16:1 challenge of failure to state a claim based on the implied theory was successful.69 there was a precedent recognizing implied false certification theory of liability but, “none of the regulations arbour violated was a condition of payment.”70 on appeal, the first circuit reversed in relevant part and remanded.71 the court emphasized that “a statutory, regulatory, or contractual requirement can be a condition of payment either by expressly identifying itself as such or by implication.”72 finally, the supreme court addressed the case and held: that the implied certification theory can be a basis for liability where at least two conditions are satisfied: first, the claim for payment must make specific representations about the goods or services provided, and second, the party’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths.73 iv. escobar analysis a. escobar decision clarifies certain fca aspects escobar is a suitable fca case because systemic and egregious violations committed by the medical center were pervasive: unlicensed and licensed professionals acted outside of their scope of practice, inadequate counseling and supervision was provided, crucial credentials such as ph.d. title were misrepresented, nurses were held out as psychiatrists and prescribed medications, basic licensure and other qualifications when obtaining national provider identification numbers were misrepresented.74 medical malpractice or criminal charges could have been brought and the massachusetts agencies already found violations of multiple state medicaid regulations.75 nonetheless, the conduct went beyond those legal frameworks and created the perfect opportunity for the supreme court to address the express-implied distinction that implicated both fca’s materiality and intent requirement: a defendant can have “actual knowledge” that a condition is material without the government expressly calling it a condition of payment. if the government failed to specify that guns it orders must actually shoot, but the defendant knows that the government routinely rescinds contracts if the guns do not shoot, the defendant has “actual knowledge.” likewise, because a reasonable person would realize the imperative of 69. id. at 1998. 70. id. 71. id. 72. id. 73. id. at 2001. 74. id. at 1997. 75. id. 2018] the false claims act and the escobar decision 11 a functioning firearm, a defendant’s failure to appreciate the materiality of that condition would amount to “deliberate ignorance” or “reckless disregard” of the “truth or falsity of the information” even if the government did not spell this out.76 further, even if there is an express designation as condition of payment, not every violation of such a requirement gives rise to liability.77 what matters is “whether the defendant knowingly violated a requirement that the defendant [knew was] material to the government’s payment decision.”78 the court gives significance to the “must be material” determination with the term material according to the act leading to examining whether the false claim influenced or was capable of influencing the government’s decision.79 materiality is a demanding standard since the complaint must now clearly state how a certain violation is material to the government’s decision to pay. after all, fca is not only about noncompliance, but if and how would that noncompliance influence the government’s reimbursement decision. the parameters provided by the court show that the requirements under the implied theory are not rigid. fca imposes liability on those who present “false or fraudulent claims”80 and after the ruling in escobar, also to certain claims of misrepresentations about express conditions of payment. the ruling may be interpreted as if the court expanded the fca language. courts must interpret legislative intent from the statute as written, not what the legislature might have said or add words that the legislature did not include.81 however, the court in escobar explained that they have not expanded the language because the court saw no restrictions made by congress in the text. the court states that the interpretation it gives exists, implicitly, in the statute.82 at the end the court did not side completely with either party. the case was 76. id. at 2001-02. 77. id. at 2001. 78. id. at 1996 (“must be material”). 79. see 31 u.s.c. § 3729(b)(4) (2012). 80. 31 u.s.c. § 3729(a)(1)(a). 81. see estate of cowart v. nicklos drilling co., 505 u. s. 469, 476 (1992) (stating that the basic and unexceptional rule is that the “courts must give effect to the clear meaning of statutes as written.”). see also larry m. eig, cong. research serv., statutory interpretation: general principles and recent trends (dec. 2011), https://fas.org/sgp/crs/misc/97-589.pdf, [https://perma.cc/x2us-xv67] (“[c]ourts will construe the details of an act in conformity with its dominating general purpose, will read text in the light of context and will interpret the text so far as the meaning of the words fairly permits so as to carry out in particular cases the generally expressed legislative policy.”). 82. if congress does not agree with the supreme court, it can effectively overrule the decision. when fca is at issue, it would not be the first time. see allison engine co. v. united states ex rel. sanders, 553 u.s. 662 (2008), (superseded by statute, fraud enforcement and recovery act (fera) of 2009, pub. l. no. 111-21, 123 stat. 1617 (codified as amended in sections 18 and 31 of u.s.c.)). 12 indiana health law review [vol. 16:1 vacated and remanded for reconsideration of whether there was sufficient pleading of fca.83 it is up to the lower courts to resolve cases in accordance with this ruling and guidance provided by the supreme court. accordingly, tailoring would be necessary since the circumstances of each case might differ drastically and case-by-case analysis is necessary. the court was careful not to make a broad ruling by stating “we need not resolve whether all claims for payment implicitly represent that the billing party is legally entitled to payment.”84 universal unsuccessfully attempted to make a policy argument stating that “liability should be limited to…expressly designated conditions of payment” so that the defendant has fair notice and would not be exposed to open ended liability.85 nevertheless, the court stated that “policy arguments could not supersede the clear statutory text.”86 as for fair notice and open ended liability concern, the court stated that they can be “effectively addressed through strict enforcement of the act’s materiality and scienter requirements.”87 for example, if noncompliance is minor or insubstantial, materiality cannot be found. ultimately, even if universal’s position was accepted, the government might have designated an almost endless list of conditions of payment and accordingly, subject universal and other healthcare entities expressly to even more regulations. such holding would not have helped the defendants and the healthcare industry in the long run because the impact would have been temporary in nature—lasting only until the government adds more to the already existing express conditions of payment. b. escobar clarifies other prior decisions escobar is consistent with mcninch88 in reiterating that fca has an outer boundary—it is not designed to punish every type of fraud committed upon the government. “it was not intended to operate as a stalking horse for enforcement of every statute, rule, or regulation.”89 further, escobar is consistent with mikes in that “a claim cannot be determined to be true or false without consideration of whether the decision maker should pay the claim…a claim is ‘false’ only if the…facts about the misconduct alleged to have occurred were known.”90 the 83. escobar,136 s. ct. at 2004. 84. id. at 2000. 85. id. at 2002. 86. id. (citing kloeckner v. solis, 133 s. ct. 596, 607 n.4 (2012)). 87. id. 88. united states v. mcninch, 356 u.s. 595 (1958). 89. united states ex rel. pogue v. american healthcorp, inc., 914 f. supp. 1507, 1513 (m.d. tenn. 1996). escobar and all the lower courts have highlighted that when a provider fails to comply with a regulation, the claim is not automatically “false” within the meaning of the fca. escobar, 136 s. ct. at 2003. 90. united states ex rel. mikes v. straus, 274 f.3d 687 (2d cir. 2001) (quoting clarence t. kipps, jr. et al., materiality as an element of liability under the false claims act, a.b.a. center for continuing legal educ. nat’l inst. (1998)). 2018] the false claims act and the escobar decision 13 supreme court just like the second circuit saw the statutory language as simply requiring linkage of the wrongful activity to the government’s decision to pay. it should be emphasized that what is relevant is the influence on the government’s disbursement decisions.91 what the second circuit got wrong is “[s]pecifically, implied false certification is appropriately applied only when the underlying statute or regulation upon which the plaintiff relies expressly states the provider must comply in order to be paid.”92 escobar effectively overturns the express requirement. under escobar, there is no need for the payment to be expressly precluded because of some noncompliance by the defendant. additionally, court decisions dismissing claims because relators have not cited to statute or regulations that conditions payment of a claim, are also overturned.93 what matters is what is at the core of the provider’s agreement with the government, the label of express or implied is relevant but not dispositive.94 c. escobar leaves some fca aspects for the lower courts to evaluate the supreme court’s reasoning and analysis in escobar do not simplify nor stabilize the materiality area by providing criteria or firm guidance as there is no clear-cut test on what is material and what is not. additionally, how lower courts interpret escobar over time will point out if the scope established by the supreme court is wide or narrow. how would implied certifications that render a claim “false” be distinguished from those that do not? there is no simple answer, but there is heavy reliance on what the defendant knew about the government’s payment practices and, moreover, what could be shown to influence or is capable of influencing the government’s payment decision.95 further, when stating, “at least in certain circumstances, the implied false certification theory can be a basis for liability,” the court did not attempt to expressly enumerate those “certain circumstances.”96 undoubtedly, it may not be possible for a law aimed at various type of conduct (predominantly in the healthcare and government contracting industry) to be any more specific. there is confidence that the lower courts will know how to adequately assess. 91. see mikes, 274 f.3d at 687; escobar, 136 s. ct. at 1989. 92. mikes, 274 f.3d at 700. 93. united states ex rel. chesbrough v. vpa, p.c., 655 f.3d 461, 469 (6th cir. 2011). 94. escobar, 136 s. ct. at 2001. 95. see escobar, 136 s. ct. at 1989; see also supra notes 17-19. 96. escobar, 136 s. ct. at 1995. the court provided a general guidance regarding those certain circumstances: “[s]pecifically, liability can attach when the defendant submits a claim for payment that makes specific representations about the goods or services provided, but knowingly fails to disclose the defendant’s noncompliance with a statutory, regulatory, or contractual requirement. in these circumstances, liability may attach if the omission renders those representations misleading.” 14 indiana health law review [vol. 16:1 d. implications from escobar favorable to the relators and the government the escobar ruling enables the government and the relators to bring an fca cause of action utilizing the implied certification theory.97 with the recognition of the theory by the supreme court, the fca’s reach is expanded and access to the federal courts is granted anywhere in the united states. prior to escobar, support for the implied theory existed in many, but not all, circuits. the decision was a victory for the government since it is a powerful tool for enforcing variety of fca violations.98 the healthcare entities would not be able to escape liability if there is no express certification, thus there is no longer a clear loophole that was created by the heavy reliance on conditions of payment in some jurisdictions. escobar enables the government to pursue wider range of violations. numerous amicus briefs were filed from various healthcare entities supporting universal as their exposure to liability was also at stake;99 and once the ruling came, the potential liability for all of them significantly increased. a violation could be deemed material even if it is not condition of payment, making fca charge possible. since labels are not dispositive, what is relevant is whether the defendant knowingly violated a requirement that the defendant knew was material to the government’s payment decision.100 however, these aspects may not be necessarily favorable for relators or the government, because it depends on how well intent and materiality can be pleaded and proved. finally, even before escobar, bringing civil fca was advantageous, in comparison to the criminal one for example, as protections afforded under criminal procedure and the constitution, would not be available to the defense.101 e. implications from escobar favorable for the defense as standards, materiality and scienter significantly limit the imposition of fca liability. the government and the relator have the burden to prove that the defendant knowingly violated the requirement that the defendant knew was material to the government’s payment decision. this leaves room for the defense to contend what the defendant knew and did not know. additionally, the complaint must state how the misrepresentation is material to the government’s 97. id. at 1989. 98. id. liability is not limited to the express false certification theory. (“contrary to universal health’s contentions, fca liability for failing to disclose violations of legal requirements does not turn upon whether those requirements were expressly designated as conditions of payment.”) 99. a complete list of brief amici curiae is available. universal health services v. united states ex rel. escobar, scotusblog, http://www.scotusblog.com/case-files/cases/universalhealth-services-v-united-states-ex-rel-escobar/ [https://perma.cc/hjc3-8kcb]. 100. escobar, 136 s. ct. at 2001-02. 101. see criminal cases, u.s. courts, http://www.uscourts.gov/about-federal-courts/typescases/criminal-cases [https://perma.cc/zs5n-mu7u]; see also your basic constitution rights in the criminal justice system, georgialegalaid.org, https://www.georgialegalaid.org/ resource/your-basic-constitutional-rights-in-the-crimi [https://perma.cc/z5u3-d3k5] (brief overview of the basic constitutional rights in a criminal case). 2018] the false claims act and the escobar decision 15 payment decision. moreover, not every contractual term violation (express or implied) gives rise to a cause of action since violations are not automatically material. escobar, just like mikes and all other circuits that recognized the implied theory prior, emphasizes a crucial aspect for the defense—not every regulation is part of the bargain that leads to payment. simple demand for payment without arguing misrepresentation is not actionable. as one author has stated, “[t]he fact that a hospital fails, for example, to have the exact number of florescent lights, as stipulated somewhere in the regulatory regime under which it functions, does not render all its submitted claims ‘false,’ but a claim submitted for an operation performed in the dark might render a bill for that surgery ‘false.’”102 also, after escobar, fca remains unproblematic for the defense if there are no gross deficiencies or systematic practices that lead to improper billing. it is also still an option for the defense to argue that if the government pays a particular claim in full, despite its actual knowledge that certain requirements were violated, that would be a strong evidence that those requirements are not material since the government knew. in the post-escobar decision world, the initial burden is on the government and relators to state how the decision to pay was material. due to this higher bar set for the government, 12(b)(6) motions claiming deficiencies in pleadings or summary judgment motions might increase. further, it can be expected that many defendants in the future will attempt to distinguish their case from escobar claiming that their case is not one of those “certain circumstances” that the supreme court was referring to in escobar. extreme violations were present in escobar: death of a teenager followed from a treatment in a setting where only few employees were licensed to provide mental health counseling or authorized to prescribe medications, and counseling services were provided without adequate supervision.103 a nurse held out as psychiatrist without authority to prescribe medications and twenty-three employees in total lacked licenses to provide services.104 many severe violations occurred: use of payment codes that did not correspond to the actual services provided, the staff members misrepresented their qualifications and licensing status to obtain national provider identification numbers, and used the national provider identification numbers according to specific job titles.105 therefore, the defendants after escobar could state that their violations including the misrepresentations are not as severe and consequently, not analogous so as to make the standards of materiality and scienter clearly met. v. adequacy of the pleadings besides the ruling in escobar, there are other issues that counsel should be aware of when faced with an fca suit. there are frequently observed 102. sara rosenbaum et al., law and the american health care system 1144 (2nd ed. 2016). 103. escobar 136 s. ct. at 1993, 1997. 104. id. at 1997. 105. id. 16 indiana health law review [vol. 16:1 deficiencies in the pleadings that could greatly impact the fca case. for example, once a suit is filed, the defendants could immediately make a motion under rule 12 or rule 56.106 the complaint would be dismissed pursuant to rule 12(b)(6) if the relator and the government, who have the initial burden, are unable to establish the required elements as a matter of law.107 the motion to dismiss tests the legal sufficiency of the fca asserted claim. the defendants would argue that there is insufficiency of the complaint as required by rules 8 and/or 9(b) of civil procedure.108 for rule 8 to be satisfied, the “[f]actual allegations must be enough to raise [the] right to relief above the speculative level [regarding] the assumption that all of the complaint’s allegations are true.”109 the defendant would win the motion to dismiss if the complaint does not contain sufficient facts for a court to draw an inference that the defendant is liable for the alleged conduct.110 vague allegations are insufficient.111 however, the initial challenge in the fca suit is to make sure that there is sufficiency under both, rule 8 and 9(b). deciding the sufficiency of these two requirements is not done in the abstract, it depends on the facts of each case.112 besides motion to dismiss, the defendants might easily move for summary judgment under rule 56 if the record is silent on any important element. for example, the plaintiff must come forward with at least a “single false [or fraudulent] claim” that the defendants submitted to the government for payment.113 many of the fca complaints are very long but the courts closely inspect the stated factual and legal aspects in them. the seventh circuit dismissed a complaint for failure to state a claim that in total had 155 double-spaced pages, 106. see fed. r. civ. p. 12(b)(6); fed. r. civ. p. 56. 107. see united states ex rel. mobin v. desert construction, 87 f.3d 1325 (9th cir. 1996) (the district court may dismiss an action for failure to comply with any order of the court). 108. united states ex rel. wilkins v. united health grp., inc., 659 f.3d 295, 301 (3rd cir. 2011) (the defendant argued that motion to dismiss 12(b)(6) should be granted based on failure to satisfy rule 8, then alternatively argued that it should be granted based on a failure to plead with particularity rule 9(b)). 109. bell atl. corp. v. twombly, 550 u.s. 544, 555 (2007); see also ashcroft v. iqbal, 556 u.s. 662, 677-81 (2009). 110. twombly, 550 u.s. at 555. 111. compare united states ex rel. blundell v. dialysis clinic 2011 wl 167246, 10-12 (n.d.n.y. 2011) (dismissal due to vague allegations of improper documentation, billing, and staffing; no adequate allegation that dialysis provided was worthless), with united states ex rel. landers v. baptist mem’l. health care corp., 525 f. supp. 2d 972, 979-80 (w.d. tenn. 2007) (allegations of improper staffing and sterilization of equipment did not allege that the care rendered was worthless). 112. anchorbank, fsb v. hofer, 649 f.3d 610, 615 (7th cir. 2011); williams v. wmx tech., inc., 112 f.3d 175, 178-179 (5th cir. 1997). 113. united states ex rel. quinn v. omnicare inc., 382 f.3d 432, 440 (3rd cir. 2004) (holding that the district court correctly granted the defendant’s federal rule of civil procedure 56(f) motion for summary judgment based on the plaintiff’s failure to identify a single claim for payment to the government arising from defendant’s alleged medicare fraud). 2018] the false claims act and the escobar decision 17 more than 400 numbered paragraphs and 99 attachments.114 “you’d think that all this paper and ink would be enough to narrate at least one false claim.”115 precision in drafting remains imperative. a. pleading fraud with particularity—9(b) heightened pleading requirement the fca is anti-fraud statute and claims under it are subject to the heightened pleading requirement under rule 9(b).116 satisfying rule 9(b) could be burdensome. the pleading requirements enumerated in rule 9(b) state that “in alleging fraud or mistake, a party must state with particularity the circumstances constituting the fraud or mistake. malice, intent, knowledge, and other conditions of a person’s mind may be alleged generally.”117 in order to satisfy the particularity requirement for pleading a fraud claim, a complaint must specify “the who, what, when, where, and how” of the conduct charged.118 “a pleading is sufficient under 9(b) if it identifies the circumstances constituting fraud so that a defendant can prepare an adequate answer from the allegations.”119 the heightened pleading standard is also designed to prevent “fishing expeditions,” to protect defendants’ reputations from allegations of fraud, and to narrow potentially wide-ranging discovery to relevant matters.120 it should be anticipated that many defendants would make a 9(b) motion and argue that the complaint fails to plead fraud with particularity, drawing attention to what is stated and missing in the fca complaint. while escobar did not change this procedural framework, even more specificity in pleading would be needed after the decision because how the government’s decision to pay was influenced or was capable of being influenced has to be clearly stated. additionally, the specific allegations of the defendant’s knowledge are crucial. b. pleading fraud in fca context courts have provided direction as to how the 9(b) standard should be applied 114. united states ex rel. garst v. lockheed-martin corp., 328 f.3d 374, 376 (7th cir. 2003). 115. id. at 376-77 (length and complexity may doom a complaint by obfuscating the claim’s essence). 116. id. at 376. (rule 9(b) is applicable “because the false claims act condemns fraud but not negligent errors or omissions.”). 117. fed. r. civ. p. 9(b). 118. united states ex rel. cafasso v. gen. dynamics c4 sys., inc., 637 f.3d 1047, 1055 (9th cir. 2011) (quoting ebeid ex rel. united states v. lungwitz, 616 f.3d 993, 998 (9th cir. 2010)). 119. moore v. kayport package express, inc., 885 f.2d 531, 540 (9th cir. 1989). see also semegen v. weidner, 780 f.2d 727, 731 (9th cir. 1985) (stating that a claim for fraud must be “specific enough to give defendants notice of the particular misconduct which is alleged to constitute the fraud charged so that they can defend against the charge and not just deny that they have done anything wrong.”); yuhasz v. brush wellman, inc., 341 f.3d 559, 563 (6th cir. 2003) (“[d]efendants accused of defrauding the federal government have the same protections as defendants sued for fraud in other contexts.”). 120. united states ex rel. snapp, inc. v. ford motor co., 532 f.3d 496, 504 (6th cir. 2008). 18 indiana health law review [vol. 16:1 in the fca context.121 since fca concerns conduct that occurred on systemic or large scale level, it is highly impractical to require the plaintiff to allege each individualized act (time, place and manner) of the fraud. requiring specific citation to each instance of fraudulent conduct is impractical where the violative conduct is repeated frequently over a lengthy period of time.122 the ninth circuit joined the fifth circuit in holding that “it is sufficient to allege ‘particular details of a scheme to submit false claims paired with reliable indicia that lead to a strong inference that claims were actually submitted.’”123 prior to escobar, inferences were permitted. after escobar, there is not much space left for inferences, various connections between the submitted claims and the government’s decision to pay must be directly asserted. one court left open the possibility that a court may apply the requirements of rule 9(b) differently “in circumstances where a relator demonstrates that he cannot allege the specifics of actual false claims that in all likelihood exist, and the reason that the relator cannot produce such allegations is not attributable to the conduct of the relator.”124 hill v. morehouse medical associates, inc. was cited as an example of when this relaxed standard might be appropriate.125 in hill, the relator was a former billing department employee who alleged that she had seen claims with fraudulently altered billing codes submitted to medicare.126 although she could not identify the specific names and dates of the claims, she had personal knowledge that billings were submitted because she had worked in the billing department.127 the eleventh circuit held that her allegation sufficed to “[alert the] defendants to the precise misconduct with which they are charged.”128 the heightened pleading standard for fraud claims is also different 121. see, e.g., united states ex rel. tamanaha v. furukawa america, inc., 445 f. app’x 992, 994 (9th cir. 2011); united states ex rel. grubbs v. kanneganti, 565 f.3d 180, 190 (5th cir. 2009). 122. see united states ex rel. franklin v. parke-davis, warner-lambert co., 147 f. supp. 2d 39, 49 (d. mass. 2001) (where allegations are “complex and far-reaching, pleading every instance of fraud would be extremely ungainly, if not impossible.”); see also in re cardiac devices qui tam litig., 221 f.r.d. 318, 333 (d. conn. 2004) (“[w]here the alleged fraudulent scheme involved numerous transactions that occurred over a long period of time, courts have found it impractical to require the plaintiff to plead the specifics with respect to each and every instance of fraudulent conduct.”); cf. charles alan wright & arthur r. miller, federal practice and procedure § 1298 (3d ed. 2004) (sufficiency of a fraud pleading varies with the complexity and duration of the scheme). 123. ebeid ex rel. united states v. lungwitz, 616 f.3d 993, 998-99 (9th cir. 2010) (quoting united states ex rel. grubbs v. kanneganti, 565 f.3d 180, 190 (5th cir. 2009)). 124. united states ex rel. bledsoe v. cmty. health sys., inc., 501 f.3d 493, 504 n.12 (6th cir. 2007) (“[w]e express no opinion as to the contours or existence of any such exception to the general rule that an allegation of an actual false claim is a necessary element of a fca violation.”). 125. id.; accord hill v. morehouse med. assocs., inc., no. 02-14429, 2003 wl 22019936, at *4 (11th cir. 2003). 126. hill, 2003 wl 22019936, at *1. 127. id. at *4. 128. id. at *5 (quoting ziemba v. cascade intern., inc., 256 f.3d 1194, 1202 (11th cir. 2001)). 2018] the false claims act and the escobar decision 19 where factual information is peculiarly within defendant’s knowledge or control.129 when some of the evidence lies in the defendant’s exclusive possession, it may be difficult for the plaintiff to identify each specific action that was taken in causing the harm but can identify an overwhelming number of them. overall, the escobar ruling did not impact any of the foregoing pleading requirements. nonetheless, the decision states that further specificity in the pleadings is required to demonstrate the materiality and scienter requirements. the supreme court opinion itself reiterated that those fca requirements are demanding and rigorous, making frequent dismissals in the lower courts through either rule 12 or rule 56 motions not surprising. vi. conclusion escobar tested the theories for imposing fca liability and came out with recognizing the implied certification theory. with the enacted fca and the escobar decision, the government is given the opportunity to attach liability to a wider range of violations when various health care systemic abuses are at issue since specified conditions of payment are not determinative. however, it also places a burden on the government and relators to plead the complaint with particularity and to state sufficient facts in order to meet the materiality and scienter requirements. in the court’s view, the implied false certification theory gives effect to congress’ expressly stated purpose that the fca should reach many fraudulent attempts to cause the government to pay out sums of money or to deliver property or services.130 while this approach suggests possible openings for the relators and the government to bring suits, since they are no longer tied to the conditions of payment framework, the escobar decision also raises a number of favorable aspects for the defense. with its elements, the fca has built in mechanisms assuring proper safeguards for the defense. in the interests of consistency and predictability in the current post-escobar period, where the implied theory is no longer automatically rejected by any court,131 the fca materiality and scienter requisites as interpreted by the supreme court allow fairness for both sides. the courts in the future will apply the principles of 129. e & e co., ltd. v. kam hing enters., inc., 429 f. app’x 632, 633 (9th cir. 2011). but see new albany tractor, inc. v. louisville tractor, inc., 650 f.3d 1046, 1050-51 (6th cir. 2011) (“the plaintiff may not use the discovery process to obtain these facts after filing suit.” (stating that plaintiff must allege specific facts even if those facts are only within the head or hands of the defendants.)) 130. universal health servs., inc. v. united states ex rel. escobar, 136 s. ct. 1989, 1996 (2016). 131. but see bruce frederick et al., postescobar circuit challenges, a.b.a. (sept. 27, 2018), https://www.americanbar.org/groups/health_law/publications/aba_health_esource/20162017/november2017/postescobar/ [https://perma.cc/pcy7-erfb] (addressing courts’ inconsistency in the treatment of the two part falsity test) (“courts across the country are inconsistent: a june 2017 law360 review of the 22 cases addressing the issue post-escobar found seven courts holding the test as mandatory, six finding it optional, and nine having ambiguous rulings.”) 20 indiana health law review [vol. 16:1 escobar to those requirements. in the end, however, some of the fatal defects for any fca case remain the same, including many of the above-mentioned issues such as: the lack of identifying objectively false claim, failure to meet the rule 8 and rule 9(b) requirements, the cause of action focuses on insignificant violations or violations more adequate for medical malpractice charges, etc. a hospital-within-a-hospital: good for hospitals, good for patients patricia connelly i. introduction ................................................................ 547 a. the issue ................................................................... 554 b. roadmap .................................................................... 554 ii. background ................................................................. 555 a. medicare reimbursement for hospitals................. 555 within-hospitals ....................................................... 555 b. hospital-within-a-hospital design and operation . 557 1. separateness requirement: basic functions ....... 560 2. separateness requirement: contracts with hospital within-a-hospital no more than fifteen percent of host’s total inpatient operating costs ..................... 561 3. separateness requirement: inpatient population referral ........................................................................ 563 c. alternatives to hospitals-within-hospitals ............ 563 iii. advantages of hospitals-within-hospitals ......... 565 a. a hospital-within-a-hospital increases ................. 565 physician empowerment ......................................... 565 b. reduction in readmission rates .............................. 569 c. specialty hospitals expand access to care ............. 572 d. a unique model of "separateness" ........................... 574 iv. problems associated with a hospital within-a-hospital ............................................................. 581 a. overbilling ................................................................. 581 b. “separateness” as an impediment to ....................... 584 disaster preparedness ............................................. 584 v. conclusion .................................................................. 592  j.d. candidate, 2016, indiana university-robert h. mckinney school of law; b.s., 2011, oklahoma state universiy. http://dx.doi.org/10.18060/3911.0026 2016 547 a hospital-within-a-hospital: good for hospitals, good for patients i. introduction hospitals face constant pressure to achieve both financial health and their mission of promoting health and wellness within the communities they serve. the ever-changing regulatory landscape of the health care industry forces hospitals to constantly adapt to new methods of treating patients while meeting specific quality measures and managing their budgets. hospitals are complex organizations and keeping them afloat operationally is a difficult task, fraught with financial penalties and bad publicity for any missteps. credit rating agencies are forecasting a negative outlook for non-profit healthcare due to credit ratings downgrades, decreases in cash, and the uncertainty that the newly elected 2015 republican-led congress will make changes to the patient protection and affordable care act, also known as the affordable care act (“aca”) or “obamacare.”1 as hospitals adjust to the new regulatory requirements of the affordable care act, like value-based purchasing, more penalties for hospital acquired conditions, and the 1 robin respaut, grim outlook for healthcare, hospital sector in 2015: rating agencies, reuters (dec. 16, 2014, 7:08 pm), http://www.reuters.com/article/2014/12/17/us-healthcare-nonprofitratings-iduskbn0jv00r20141217 [http://perma.cc/ly5c-yzny]. under a republican majority, the house of representatives has held more than 50 votes to either repeal or defund parts of the aca or the entire aca since it became law in 2010. house gop to hold first obamacare repeal vote of new congress, fox news (jan. 27, 2015), http://www.foxnews.com/ politics/2015/01/27/house-gop-to-hold-first obamacare-repeal-vote-new-congress/ [http://perma.cc/357q-zs5m]. 548 indiana health law review vol. 13:2 readmissions reduction program, they are forced to make adjustments. value-based-purchasing is an incentive system that will change the amount hospitals are paid based on their performance. payments to hospitals will be adjusted based “on their performance on 4 domains that reflect hospital quality: the clinical process of care domain, the patient experience of care domain, the outcome domain, and the efficiency domain.”2 the aca mandates “a hospital valuebased purchasing program in medicare to pay hospitals based on performance on quality measures.”3 fee-for-service models of reimbursement, where hospitals charge for each service performed on the patient as opposed to overall outcome, are being supplanted by value-based care. valuebased care is a growing trend among the biggest insurance companies, because insurance companies tend to follow medicare and medicaid trends.4 a shift toward value-based reimbursements has been a major driver of healthcare reform, and united healthcare is not the only commercial payer to signal a major shift toward this strategy. aetna and cigna have been two of the most active private health insurers to create acos and 2 hospital value-based purchasing, medicare.gov, http:// www.medicare.gov/hospitalcompare/data/hospital-vbp.html [http:// perma.cc/a9k8-hcfc] (last visited feb. 12, 2016). 3 summary of the affordable care act, the kaiser fam. found. (apr. 25, 2015), http://kff.org/health-reform/fact-sheet/summary-of-theaffordable-care-act/ [http://perma.cc/5nnp-wckv]. 4 bob herman, united healthcare to double value-based contracts with providers by 2017, becker’s hosp. rev. (july 10, 2013), http://www.beckershospitalreview.com/accountable-care-organizations/ unitedhealthcare-to-double-value-based-contracts-with-providers-by2017.html [http://perma.cc/zk4n-wjyh]. 2016 549 a hospital-within-a-hospital: good for hospitals, good for patients accountable care deals with hospitals and physicians.5 seeking to reduce inefficiencies in care is important to insurers as well.6 value-based care will pressure hospitals and health care providers to shift resources toward improving areas measured by these metrics. beginning in october of 2008, hospitals had to supply information about conditions present on admission (“poa”) and did not “receive additional payment for cases in which one of the selected conditions was not present on admission. that is, the case would be paid as though the secondary diagnosis were not present.”7 basically, the policy is based 5 id. 6 bruce japsen, blue cross’ $65 billion move away from fee-forservice medicine, forbes (july 9, 2014, 11:00 am), http:// www.forbes.com/sites/brucejapsen/2014/07/09/blue-cross-65-billionmove-away-from-fee-for-service-medicine/ [http://perma.cc/xdk5-47tw]. 7 hospital-acquired conditions (present on admission indicator), cms.gov, http://www.cms.gov/medicare/medicare-fee-for-servicepayment/hospitalacqcond/index.html?redirect=/hospitalacqcond/06_ho spital-acquired_conditions.asp [http://perma.cc/9atz-9hu2] (last visited feb. 28, 2016). the details of this program are as follows: on february 8, 2006, the president signed the deficit reduction act (dra) of 2005. section 5001(c) of dra requires the secretary to identify conditions that are: (a) high cost or high volume or both, (b) result in the assignment of a case to a drg that has a higher payment when present as a secondary diagnosis, and (c) could reasonably have been prevented through the application of evidence-based guidelines. section 5001(c) provides that cms can revise the list of conditions from time to time, as long as it contains at least two conditions. id. 550 indiana health law review vol. 13:2 on the idea that the government should not reward hospitals for treating patients for conditions that a patient contracted while at the hospital that could have potentially been avoided by better hospital practices. this payment structure encouraged hospitals to take measures to combat hospital-acquired conditions (“hacs”). additional penalties for hospital-acquired conditions (“hacs”) were implemented by obamacare.8 this program will result in reduced medicare payments to hospitals that do not meet quality metrics involving hospital acquired conditions. a score is created for hospitals based on rank in the worst performing quartile . . . with respect to hospital-acquired conditions . . . . identified by calculating a total hac score which is based on the hospital’s performance on risk adjusted quality measures. hospitals with a total hac score above the 75th percentile of the total hac score distribution may be subject to payment reduction beginning october 1, 2014.9 hospitals must make investments to develop or refine internal processes that prevent patients from acquiring additional illnesses during their stay. established by the affordable care act, the readmissions reduction program also imposes penalties on hospitals.10 the secretary of the health and human services agency 8 hospital-acquired condition reduction program, medicare hosp. compare, http://www.medicare.gov/hospitalcompare/hac-reductionprogram.html [http://perma.cc/t6we-6q35] (last visited mar. 12, 2015). 9 linking quality to payment, medicare hosp. compare, http://www.medicare.gov/hospitalcompare/linking-quality-topayment.html?aspxautodetectcookiesupport=1 [http://perma.cc/3egdcawk] (last visited feb. 28, 2016). 10 id. 2016 551 a hospital-within-a-hospital: good for hospitals, good for patients (“hhs”) is charged with taking excess readmissions into consideration when making payments to hospitals.11 in addition to financial penalties, the readmissions rates will also be posted on the cms website “hospital compare.”12 this will impact hospitals as consumers will have the opportunity to research prices for different procedures before selecting a hospital or outpatient clinic. carrots and sticks like value-based purchasing, the readmissions reductions program, and hac program are “the wave of the future for hospital payments and should be viewed as a cumulative force demanding performance improvement[.]”13 additionally, “[b]y 2017, the combined penalties will put as much as 6% of inpatient medicare reimbursements at risk.”14 this will put pressure on hospitals to react to this new status quo. in march of 2015, the supreme court heard oral arguments on king v. burwell, where it was argued that the subsidies from the federal government for people who purchased health insurance from the federal health insurance exchange were illegal, based on the interpretation of an irs rule.15 the outcome of king v. burwell was to have an impact on whether individuals, in states that only use the federal health insurance exchange market, 11 42 u.s.c. § 1395ww(q) (2016). 12 42 u.s.c. § 1395ww(q)(8)(b) (2016). 13 sabriya rice et al., more hospitals to get bonuses than penalties in 2015 under value-based purchasing, modern healthcare (dec. 18, 2014), http://www.modernhealthcare.com/article/20141218/news/ 141219982 [http://perma.cc/fm58-28t9]. 14 id. 15 king v. burwell, 135 s. ct. 2480, 2482 (2015). 552 indiana health law review vol. 13:2 healthcare.gov,16 would receive subsidies to help them afford health insurance.17 thirty-four states relied on the federal exchange for their insurance market, and roughly six and a half million people stood to lose their subsidies if the supreme court found that the federal health insurance exchange markets were illegal.18 without the subsidies, less patients would have insurance, and the amount of uninsured patients would likely increase. subsidies have made an impact on hospital debt because they result in less uninsured patients whose costs hospitals have to absorb.19 in 2015, there was an increase in the number of indiana residents who enrolled through the federal marketplace.20 enrollment for hoosiers was 132,423 in 2014, and in 2015 it increased to 218,617.21 the increased number of insured patients has resulted in a surge in patient volume, but hospitals are struggling with the costs of increasing staff to handle the patient volume.22 the uncertainty around the king decision made it difficult for hospitals to operate efficiently while they evaluated whether or not they should maintain staff at current levels and proceed as if the number of insured patients will continue to increase or if they need to reduce staff if the pool of insured patients decreases if subsidies are not preserved. although 16 healthcare.gov, http://www.healthcare.gov/ [http://perma.cc/ gv8c-uedt68h4-jnj3] (last visited feb. 12, 2016). 17 king v. burwell, 135 s. ct. 2480, 2482 (2015). 18 the health care supreme court case: who would be affected? n.y. times, http://nytimes.com/interactive/2015/03/03/us/potentialimpact-of-the-supreme-courts-decision-on-health-caresubsidies.html?_r=0 [http://perma.cc/82ce-2kju] (last updated june 22, 2015). 19 caroline humer & bill berkrot, u.s. hospitals optimistic they’ll dodge bullet with obamacare ruling, reuters (mar. 4, 2015, 6:16 pm), http://www.reuters.com/article/2015/03/04/us-usa-court-healthcarehospitals-iduskbn0m02nc20150304 [http://perma.cc/3pu9-c9sr]. 20 barbara brosher, more hoosiers enroll in healthcare coverage for 2015, ind. pub. media (feb. 18, 2015), http:// indianapublicmedia.org/ news/hoosiers-enroll-healthcare-coverage-2015-78383/ [http://perma.cc/ 95dg-eldg]. 21 id. 22 beth kutscher, reform update: hospitals see more paying patients, but there’s a hitch, modern healthcare (aug. 20, 2014), http://www.modernhealthcare.com/article/20140820/news/308209965 [http://perma.cc/wa5a-8skk]. 2016 553 a hospital-within-a-hospital: good for hospitals, good for patients the outcome of king maintained the subsidies, hospitals will continue to face great uncertainty as different aspects of the aca are attacked and reviewed, especially during the upcoming presidential election. the competition among hospitals and the internal pressures within hospitals is fierce. pressure to gain new patients, maintain prowess in the community, achieve financial stability, and provide the best care possible to all patients is intense. as a result of this increasing competitive pressure, it is not uncommon for the public to frequently encounter commercials and billboards advertising shorter wait times in emergency rooms, new specialty centers, and a facility’s latest ranking of varying significance. the inundation of advertisements gives the prospective patient the impression that the hospitals are all trying to shout over one another in an effort to attract the patient’s attention and business. as more people are covered by high-deductible insurance plans, where patients must pay a greater amount out of pocket before their health care costs are covered by their insurance, there is a general sense that patients are interested in greater price transparency. the indiana hospital association created a tool called careinsight for patients to view aggregated hospital price and quality data for the more than 165 hospitals in indiana based on the chargemasters hospitals submit to the indiana state department of insurance.23 while this tool is not a perfect 23 j.k. wall, hoosier hospitals create new tool to help health care shoppers, ind. bus. j. (jan. 5, 2015), http://www.ibj.com/blogs/12-thedose/post/51173-hoosier-hospitals-create-new-tool-to-help-health-careshoppers?utm_source=ibj554 indiana health law review vol. 13:2 way to view all relevant data because it does not include information from all of the different payers who will pay for hospital procedures, the number of all-payer claims databases is likely to grow.24 all-payer claims databases will put pressure on hospitals to incur additional administrative costs in order to maintain this information. there are many pressures on hospitals to be more efficient without sacrificing quality. these challenges present an opportunity for hospitals to create new structures to adjust to this pressure while managing patient satisfaction, quality, and their bottom line. a. the issue as discussed above, the health industry is facing many new regulatory changes that present operational and financial challenges. colocation via the hospital-within-ahospital structure could relieve some of the pressures hospitals must navigate. the unique structure of a hospitalwithin-a-hospital provides a means for hospitals to gain financial efficiencies, and improve patient care by reducing readmission rates by ensuring patients receive better care, and providing a means for catholic hospitals that acquire secular hospitals to address the needs of the communities they serve while adhering to their moral objectives. b. roadmap this note will examine the “hospital-within-a-hospital” structure under the general rules for hospitals excluded from the prospective payment systems25 and analyze the advantages and disadvantages of this structure for hospitals and patients. also analyzed is how the hospital-within-ahospital structure provides a means to ease the impact of daily&utm_medium=newsletter&utm_content=thedose&utm_campaign=2015-01-06 [http://perma.cc/3wnx-wqs2]. 24 id; see also apcd council, the basics of all-payer claims databases: a primer for states, robert wood johnson found. (jan. 2014), http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2014/ rwjf409988 [http://perma.cc/39af-n7xx]. 25 42 c.f.r. § 412.22 (2016). 2016 555 a hospital-within-a-hospital: good for hospitals, good for patients regulatory uncertainty on hospitals and how the type of hospitals, currently allowed to operate hospitals-withinhospitals, should be expanded to include hospitals other than specialty hospitals. part ii of this note will discuss the medicare reimbursement for a hospital-within-a-hospital, the design and operation of the hospital-within-a-hospital, the requirements hospitals must adhere to in order to be compliant with the regulation and therefore receive the appropriate type of medicare reimbursement, and alternatives to hospitals-within-hospitals. part iii of this note will analyze the advantages of the hospital-within-a-hospital including: potential reduction in readmission rates for the host hospital which in turn benefits the patients as consumers of health care, an increase in access to specialty hospitals, and how the separateness of the structure could increase access to certain services. explored in part iv of this note are the disadvantages of the hospital-within-a-hospital, including overbilling, which leads to medicare overpayment, and complications that arise when disaster preparedness is inadequate between the hospital-within-a-hospital and the host hospital. ii. background a. medicare reimbursement for hospitals within-hospitals even though participation is voluntary, hospitals choose to participate in the medicare program for a variety of 556 indiana health law review vol. 13:2 reasons, such as tax exemptions.26 health care providers who want to accept medicare payments must abide by cms regulations. medicare is a health insurance program run by the centers for medicare and medicaid services (“cms”), as the operating agent of the department of health and human services (“hhs”), meant to assist both the elderly and the disabled.27 hospitals agree to provide hospital services to those eligible for medicare when hospitals file their agreement with the secretary of hhs.28 acute care hospitals agree to accept inpatient prospective payment system (“ipps”) payments when they deliver inpatient care to medicare patients.29 medicare pays for acute care hospital operating costs under a system called the prospective payment system (“inpatient pps”), where each discharge is paid for according to a predetermined specific rate.30 the prospective payment system was established for: the operating costs of inpatient hospital services furnished to medicare beneficiaries in cost reporting periods beginning on or after october 1, 1983 and a prospective payment system for the capital-related costs of inpatient hospital services furnished to medicare beneficiaries in 26 underpayment by medicare and medicaid fact sheet, am. hosp. ass’n, 1 (nov. 2009), www.aha.org/content/00100010001000-100010/ 09medicunderpayment.pdf [http://perma.cc/5rfm-dn3r]. 27 select specialty hosp. akron, llc v. sebelius, 820 f. supp. 2d 13, 15-16 (d.d.c. 2011). 28 42 u.s.c. § 1395cc (2016). 29 dept. of health and human svcs. ctrs. for medicare & medicaid svcs., acute care hospital inpatient prospective payment system (apr. 2013), http://www.cms.gov/outreach-and-education/medicare-learningnetwork-mln/mlnproducts/downloads/acutepaymtsysfctsht.pdf [http://perma.cc/y2pn-35xv]. . 30 see select specialty hosp., 820 f. supp. 2d at 17. 2016 557 a hospital-within-a-hospital: good for hospitals, good for patients cost reporting periods beginning on or after october 1, 1991.31 payments made to participating hospitals are made on the basis of prospectively determined rates and applied on a per discharge basis.32 the payment system is not structured in a way to reimburse hospitals for long-term hospital care because the average stay for medicare patients at general acute-care hospitals is roughly six days.33 a hospital-withina-hospital is excluded from this payment system. instead, they are compensated at a level that is often more favorable. b. hospital-within-a-hospital design and operation under 42 c.f.r. § 412.22(e), “excluded hospitals and hospital units: general rules”, a hospital-within-a-hospital is a hospital that operates in the same building as its host hospital or in a building on the same campus as its host hospital.34 this is sometimes referred to as co-location.35 the host hospital is “a general acute care hospital located in the same building or on the same campus as [a long-term-care 31 42 c.f.r. § 412.1(a) (2016). 32 id. 33 see select specialty hosp., 820 f. supp. 2d at 17. 34 42 c.f.r. § 412.22(e) (2016). 35 cherilyn g. murer, separate but related—hospitals within hospitals and the 15 percent inpatient operating costs limitations 1, available at http://murer.com/pdfs/articles/thecolocationequation.pdf [http://perma.cc/6295-z3sh]. 558 indiana health law review vol. 13:2 hospital].”36 colocation is typically arranged through a lease arrangement.37 facilities that meet the requirements for a hospitalwithin-a-hospital are excluded from this medicare inpatient prospective payment system.38 in order to be the type of facility allowed to become a hospital-within-a-hospital, the facility must be licensed as of the several classes of “excluded hospitals.”39 these facilities include: 1. psychiatric hospitals, which must primarily provide psychiatric care, including the diagnosis and treatment of the mentally ill,40 2. rehabilitation hospitals, which must comport with specific requirements,41 3. children’s hospitals, which must have a provider agreement and provide care to patients under eighteen years of age,42 and 4. long-term care hospitals (“ltch”), which are one of the types of specialty hospitals permitted to operate as hospitals-within-hospitals, must have an average length of stay that is greater than twenty-five days.43 because of concerns involving overbilling medicare, a moratorium on all new long-term care hospitals has been established.44 in part, due to concerns about hospitals working together to double bill medicare for the same patient, there are requirements in place for a host hospital and hospital-withina-hospital to qualify for reimbursement under 42 c.f.r. § 412.22(e). maintaining separateness is at the root of the 36 select specialty hosp., 820 f. supp. 2d at 17. 37 murer, supra note 35, at 1. 38 42 c.f.r. § 412.22(e) (2016). 39 42 c.f.r. § 412.22(a) (2016). 40 42 c.f.r. § 412.23(a) (2016). 41 42 c.f.r. § 412.29 (2016). 42 42 c.f.r. § 412.23(d) (2016). 43 42 c.f.r. § 412.23(e) (2016). 44 42 c.f.r. § 412.23(e)(6) (2016). 2016 559 a hospital-within-a-hospital: good for hospitals, good for patients requirements for fulfilling the criteria to qualify as a hospital-within-a-hospital. the operations of both the host hospital and the hospital-within-a-hospital are structured in a way to prevent collusion between the host hospital and the hospital-within-a-hospital. this separateness is often signified in terms of control. control is defined as having “the power, directly or indirectly, significantly to influence or direct the actions or policies of an organization or institution.”45 the governing body of the hospital-within-a-hospital must be separate from the governing body of the host hospital.46 the chief medical officer of the host hospital, who is responsible for the actions of the medical staff, may not be employed by or have a contract with the hospital-within-a-hospital.47 the medical staff must also be separate. this means that the host hospital’s medical staff has nothing to do with the hospitalwithin-a-hospital’s staffing activities, including granting privileges.48 the chief executive officer of the host hospital may not be “employed by or under contract with the hospital occupying space in the same building or on the same campus or any third entity that controls both hospitals.”49 however, in addition to requirements on separate governance and staffing the hospital-within-a-hospital also has to meet one of the three criteria explored in further detail below to establish the separateness of the two hospitals and qualify as a hospital-within-a-hospital: 45 42 c.f.r. § 412.22(g) (2016). 46 42 c.f.r. § 412.22(e)(1)(i) (2016). 47 42 c.f.r. § 412.22(e)(1)(ii) (2016). 48 42 c.f.r. § 412.22(e)(1)(iii) (2016). 49 42 c.f.r. § 412.22 (e)(1)(iv) (2016). 560 indiana health law review vol. 13:2 1. perform “basic functions” without contracting with the host hospital to provide these services,50 2. no more than fifteen percent of the host hospitals’ inpatient operating costs may come from contracts with the hospital-within-a-hospital,51 or 3. seventy-five percent of the hospital-within-a-hospital’s inpatient population must be referred from somewhere besides the host hospital.52 1. separateness requirement: basic functions as the first option to establish separateness between the host hospital and the hospital-within-a-hospital, the hospital-within-a-hospital must perform basic hospital functions “through the use of employees or under contracts or other agreements with entities other than the hospital occupying space in the same building or on the same campus, or a third entity that controls both hospitals.”53 basic functions are defined as: “quality assurance, medical staff services, nursing services, medical record services, pharmaceutical services, radiologic services, laboratory services, utilization review, and infection control.”54 it is permissible for the hospital-within-a-hospital to contract with the host hospital or any third party that controls both hospitals to provide “food and dietetic services and housekeeping, maintenance, and other services necessary to maintain a clean and safe physical environment.”55 one of the issues with this rule is that the host hospital could provide basic functions in the most cost-effective 50 42 c.f.r. § 412.22(e)(1)(v)(a) (2016). 51 42 c.f.r. § 412.22(e)(1)(v)(b) (2016). 52 42 c.f.r. § 412.22(e)(1)(v)(c) (2016). 53 42 c.f.r. § 412.22 (e)(1)(v)(a) (2016). 54 murer, supra note 35, at 2. 55 42 c.f.r. § 412.22(e)(1)(v)(a) (2016). 2016 561 a hospital-within-a-hospital: good for hospitals, good for patients manner for the hospital-within-a-hospital.56 a hospitalwithin-a-hospital that is, for example, only comprised of twenty beds would not see operational efficiencies if it were forced to procure costly assets like radiological or laboratory equipment.57 additionally, it would inconvenience patients and increase costs if the hospital-within-a-hospital needed to call an ambulance any time a patient needed a test that the hospital-within-a-hospital was not equipped to perform and is then obligated to arrange and pay for an ambulance to transport the patient to a facility that did have the equipment.58 this option is still available. however, in response to the concerns about the lack of convenience and cost effectiveness of the basic services rule, cms added two alternatives that a hospital-within-a-hospital could choose to fulfill the idea of separate function while easing the burden of the original rule.59 2. separateness requirement: contracts with hospitalwithin-a-hospital no more than fifteen percent of host’s total inpatient operating costs as another option to establish separateness between the host hospital and the hospital-within-a-hospital, the hospital can ensure that 56 murer, supra note 35, at 2. 57 id. 58 id. 59 id. 562 indiana health law review vol. 13:2 the cost of the services that the hospital obtains under contracts or other agreements with the hospital occupying space in the same building or on the same campus, or with a third entity that controls both hospitals, is no more than 15 percent of the hospital's total inpatient operating costs . . . .60 the fifteen percent of total inpatient operating costs cap on services rule has been described as the most confusing rule for hospitals-within-hospitals because of the difficulty in accounting for which services count towards the fifteen percent.61 however, most hospitals choose to abide by this rule.62 inpatient operating costs include costs for routine services, like the cost of the room and board and nursing, ancillary services including inpatient radiology and laboratory services, and the malpractice insurance costs associated with inpatient care.63 costs that must be included in the fifteen percent maximum a hospital-within-a-hospital may contract with the host for includes equipment and facility repairs and maintenance, cleaning, utilities, and general liability insurance.64 the hospital-within-a-hospital may not contract with the host hospital or an entity that controls the host hospital for pharmacy, nursing services or medical records.65 however, the hospital-within-a-hospital is permitted to attempt to realize cost efficiencies by contracting with the host hospital for “dietetic, housekeeping, and maintenance services.”66 60 42 c.f.r. § 412.22(e)(1)(v)(b) (2016). 61 murer, supra note 35, at 1. 62 id. 63 42 c.f.r. § 412.2(c) (2016). 64 murer, supra note 35, at 4. 65 id. 66 id. 2016 563 a hospital-within-a-hospital: good for hospitals, good for patients 3. separateness requirement: inpatient population referral if a hospital chooses to adhere by the “75% rule,” no more than twenty-five percent of the inpatient population of the hospital-within-a-hospital can be referred by the host hospital.67 this means that seventy-five percent of the referrals to the hospitals must come from a source other than the host hospital.68 if a hospital-within-a-hospital chooses this option as the means to establish separateness from the host hospital, it will deny itself the opportunity to form a mutually beneficial relationship with the host hospital because most hospitals-within-hospitals “receive the bulk of their referrals from the host hospital.”69 c. alternatives to hospitals-within-hospitals it is important to note that the term “hospital-within-ahospital” is used to refer generally to any arrangement that has multiple hospitals in the same physical location, but that does not mean that the facility is a true “hospital-within-ahospital” under the statute. some hospitals market specialty floors as “hospitals-within-hospitals” when in fact they are just remote locations or satellite facilities, subject to other requirements. a satellite facility is a part of a hospital that provides inpatient services in a building also used by another hospital.70 satellite facilities are also restricted to “hosting” 67 42 c.f.r. § 412.22(e)(1)(v)(c) (2016). 68 id. 69 murer, supra note 35, at 3. 70 select specialty hosp., 820 f. supp. 2d at 17. 564 indiana health law review vol. 13:2 only psychiatric, rehabilitation, children’s, and long-term care hospitals.71 satellite facilities are also similar to hospitals-within-hospitals because they may not be controlled by the same board or ceo as the host hospital, “and it furnishes inpatient care through the use of medical personnel who are not under the control of the medical staff or chief medical officer of the hospital in which it is located.”72 hospitals are accredited by surveyors who evaluate whether or not the hospital is complying with medicare’s conditions of participation “for all services, areas and locations covered by the hospital's provider agreement under its cms certification number (ccn).”73 71 42 c.f.r. § 412.22 (h) (2016). 72 42 c.f.r. § 412.22 (h)(2)(iii)(a) (2016). 73 hospitals, cms.gov, http://www.cms.gov/medicare/providerenrollment-and-certification/certificationandcomplianc/hospitals.html [http://perma.cc/5cnh-nzdf] (last visited feb. 28, 2016). 2016 565 a hospital-within-a-hospital: good for hospitals, good for patients the satellite hospital has a “home” facility. the satellite hospital may have the same cms certification number as its originating facility.74 iii. advantages of hospitals-within-hospitals a. a hospital-within-a-hospital increases physician empowerment clinical co-management is the means by which a hospital and an independent physician group (made up of physicians who are not employed by the hospital) form a relationship to 74 the joint commission describes the ccn as: a hospital’s cms’ certification number (ccn), is the hospital’s identification number and is linked to its medicare provider agreement. the ccn is used for cms certification. certain types of health care facilities, including hospitals, seeking to participate in the medicare program are required not only to satisfactorily complete the medicare enrollment application, but also to be certified as meeting the medicare health and safety standards. the ccn is also used for submitting and reviewing the hospital’s cost reports. the ccn number used to be called the "provider number," but with the advent of the statutorily mandated national provider identifier (npi) number for claims processing, the ccn now plays a different role within the medicare program. frequently asked questions about accrediting hospitals in accordance with their cms' certification number (ccn), the joint commission (oct. 15, 2010), http://www.jointcommission.org/faqs_ccn/ [http://perma.cc/vek6-5kbk]. 566 indiana health law review vol. 13:2 work together to manage a particular area of a hospital.75 physicians struggle to maintain control of their independence as “mom and pop” shops are gobbled up by large hospital systems and they are forced to work for a large system. there are several types of relationships physician groups may form with hospitals. these include joint ventures, where the hospital and physician group form a limited liability company or other “joint venture business entity [ ] [that] then contracts with the hospital to provide defined management services and leadership.”76 the physician group then receives payment through “management fees paid by the hospital to the new entity[.]”77 physicians may also create a physician entity that contracts with the hospital, where physicians are reimbursed for “management time and incentive for achieving certain goals.”78 a hospital could “designate[] a few key administrators to sit on a council, or board, with select physicians” and work to “[d]efine[] service line or program goals and initiatives and helps to lead and coordinate hospital resources in achieving the objectives. under the broad definition, hospital leadership and physicians are working collaboratively to achieve mutually beneficial objectives.”79 none of these would compare to the freedom the physicians could have if they ran a specialty hospitalwithin-a-hospital. 75 samuel g. agnew & bryan j. warren, when does clinical comanagement make sense? 8 considerations for selecting the model right for your hospital, becker’s hosp. rev. (feb. 1, 2012), http://www.beckershospitalreview.com/hospital-physician-relationships/ when-does-clinical-co-management-make-sense-8-considerations-forselecting-the-model-right-for-your-hospital.html [http://perma.cc/rrr7zajz]. 76 id. 77 id. 78 id. 79 id. 2016 567 a hospital-within-a-hospital: good for hospitals, good for patients there have been concerns related to physician referral patterns when physicians own health care facilities, specifically that they are “more likely than other physicians to refer well-insured patients to their facilities and route medicaid patients to hospital outpatient clinics.”80 in the case of hospitals-within-hospitals, the physicians are not operating outpatient clinics. rather, they have managerial control at the hospital for which they work. this set-up will not lead to excessive or inappropriate referrals as long as guidelines are in place and physicians and hospitals understand ethical limitations. the hospital-within-a-hospital structure is highlighted as a way for physicians to regain control and be empowered to reduce medical errors. by sell[ing] off operational units to physician specialists. in a sense, hospitals would [break apart] the hospital [into smaller pieces], vesting clinical and operational control to physician owners. such a development follows a natural progression from the joint venture arrangements hospitals have engaged in with specialists in the outpatient area, and that are now seen on the inpatient side, most typically in the creation of “hospitals within” hospitals.81 80 jon r. gabel, et al., where do i send thee? does physicianownership affect referral patterns to ambulatory surgery centers?, 27 health aff. w165 (2008), available at http://content.healthaffairs.org/ content/27/3/w165/suppl/dc2 [http://perma.cc/l98l-dymu]. 81 john d. blum, feng shui and the restructuring of the hospital corporation: a call for change in the face of the medical error epidemic, 14 health matrix j.l. med. 5 (2004). http://dx.doi.org/10.1377/hlthaff.27.3.w165 568 indiana health law review vol. 13:2 any arrangements made by physicians and hospitals must not violate any health care fraud and abuse statutes. the analysis depends on the specific arrangement with the hospital and host hospital, and while the analysis is beyond the scope of this note, it is necessary to draw attention to these two important statutes. the stark law prohibits physician “self-referrals.”82 physicians are not permitted to make referrals for health services classified as “designated health services” (“dhs”).83 the stark law also “prohibits the entity from presenting or causing to be presented claims to medicare (or billing another individual, entity, or third party payer) for those referred services[]” and “[e]stablishes a number of specific exceptions and grants the secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.”84 another ethical minefield that impacts the health care industry and hospitals is what is known as the federal antikickback statute (“aks”).85 this statute calls for criminal penalties for making false statements and also for arranging for or offering illegal remunerations, meaning incentives like a bribe, to take certain actions.86 illegal remunerations are an issue with the hospital-within-a-hospital because the structure could be impermissible if hospitals were involved in schemes to exclusively refer patients to the hospitalwithin-a-hospital. 82 physician self-referral, cms.gov, http://www.cms.gov/medicare/ fraud-and-abuse/physicianselfreferral/index.html?redirect=/ physicianselfreferral/ [http://perma.cc/sl2f-65vj] (last updated jan. 5, 2015, 10:59 am). 83 42 u.s.c. § 1395nn(h)(6) (2016). dhs includes: clinical laboratory services; physical therapy services; occupational therapy services; radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services; radiation therapy services and supplies; durable medical equipment and supplies; parenteral and enteral nutrients, equipment, and supplies; prosthetics, orthotics, and prosthetic devices and supplies; home health services; outpatient prescription drugs; inpatient and outpatient hospital services. id. 84 physician self-referral, supra note 82. 85 42 u.s.c. § 1320a-7b (2016). 86 id. 2016 569 a hospital-within-a-hospital: good for hospitals, good for patients the hospital-within-a-hospital and the host hospital will need to ensure that any arrangements are not in violation of these regulations. b. reduction in readmission rates readmission penalties from the affordable care act make the hospital-within-the-hospital structure attractive as an incentive for hospitals to ensure readmission rates are low and for patients, who understandably do not wish to spend any more time than necessary in the hospital. medicare payments will be reduced as a way to penalize hospitals for readmissions. penalties have been doled out to three-fourths of hospitals that are included in the hospital readmissions program and some have said that the pressure of penalties has encouraged hospitals to improve communications with other health care providers.87 excess readmissions are a focus of the affordable care act, which established the hospital readmissions reduction program. the secretary of hhs was tasked with establishing a program for hospitals to reduce readmission rates for certain conditions.88 the policy defines readmission for certain conditions and a calculation for them.89 cms 87 jordan rau, medicare fines 2,610 hospitals in third round of readmission penalties, kaiser health news (oct. 2, 2014), http://kaiserhealthnews.org/news/medicare-readmissions-penalties2015/ [http://perma.cc/a2fg-gylp]. 88 42 u.s.c. § 280j-3 (2016). 89 readmissions reduction program (hrrp), cms.gov, http:// www.cms.gov/medicare/medicare-fee-for-servicepayment/acuteinpatientpps/readmissions-reduction-program.html 570 indiana health law review vol. 13:2 started adjusting payments to ipps hospitals that are calculated to have excess readmissions on october 1, 2012.90 excess readmissions are calculated by a specific formula through cms.91 [http://perma.cc/rjh2-sxxt] (last modified feb. 4, 2016, 1:55 pm). the policy [d]efined readmission as an admission to a subsection (d) hospital within 30 days of a discharge from the same or another subsection (d) hospital; adopted readmission measures for the applicable conditions of acute myocardial infarction (ami), heart failure (hf) and pneumonia (pn); established a methodology to calculate the excess readmission ratio for each applicable condition, which is used, in part, to calculate the readmission payment adjustment. a hospital’s excess readmission ratio [for ami, hf and pn] is a measure of a hospital’s readmission performance compared to the national average for the hospital’s set of patients with that applicable condition. established a policy of using the risk adjustment methodology endorsed by the national quality forum (nqf) for the readmissions measures [for ami, hf and pn] to calculate the excess readmission ratios, which includes adjustment for factors that are clinically relevant including certain patient demographic characteristics, comorbidities, and patient frailty. established an applicable period of three years of discharge data and the use of a minimum of 25 cases to calculate a hospital’s excess readmission ratio for each applicable condition. id. 90 id. 91 see julimes, health policy brief: medicare hospital readmissions reduction program, health aff. (nov. 12, 2013), available at http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_1 02.pdf [httpshttp://perma.cc/p52m-r55r]. excess readmissions are defined as follows: [f]or purposes of the hrrp, excess readmissions are defined as those that exceed a hospital’s “expected 2016 571 a hospital-within-a-hospital: good for hospitals, good for patients when a patient is discharged from a hospital, it is likely that some sort of follow-up or additional action has been advised, from taking medication on a certain schedule to asking the patient to be sure to check in with their primary care physician. a hospital-within-a-hospital may reduce transitional care issues between the host hospital and the specialty facility. this would benefit both the patient, who will not have to endure another hospital stay, as well as the host hospital, who will not be penalized for a readmission. a 2014 report by kaiser health news, a nonprofit health policy news service, illuminates reasons that cms is increasing its efforts to prevent readmissions.92 according to the report, “[n]early one in five fee-for-service medicare patients returns to the hospital within 30 days of being discharged[.]”93 a high readmission rate is sometimes an readmission rate.” a hospital’s expected readmission rate for each of the hrrp conditions is the national mean readmission rate, risk-adjusted for the demographic characteristics (for example, age and sex) and severity of illness of the hospital’s patients. the penalty is calculated using a complex formula based on the amount of medicare payments received by the hospital for the excess readmissions. the penalties are collected from the hospitals through a percentage reduction in their base medicare inpatient claims payments, up to a cap. the aca set the penalty cap at 1 percent of aggregate ipps base payments for the first year, 2 percent for the second year, and 3 percent for each year thereafter. id. at 3. 92 niall brennan, findings from recent cms research on medicare, cms 28, http://kaiserhealthnews.files.wordpress.com/2014/10/ brennan.pdf [http://perma.cc/l6lz-b774] (last visited feb. 28, 2016). 93 id. at 28. 572 indiana health law review vol. 13:2 “indicator of poor quality care[.]”94 additionally, of the $26 billion that readmissions will cost medicare each year, $17 billion of the costs may be avoidable.95 the hospital-within-a-hospital structure can be an effective tool to prevent excess readmissions, saving patients the hardship of enduring an additional stay at the hospital and saving medicare, and ultimately the taxpayer, the costs related to readmissions. the hospital-within-a-hospital arrangement can alleviate issues with transitional care when a host hospital transfers a patient to the hospital-within-ahospital so that the individual can receive specialized services, which in turn could improve the readmission rates for the host hospital. under the affordable care act, hospitals will face reductions in their medicare payments as a penalty for excessive readmissions.96 this means there is a financial incentive for hospitals to ensure patients receive appropriate transitional treatment. c. specialty hospitals expand access to care there are financial restraints that prevent hospitals from opening up new children’s hospitals in order to capture more business and serve additional populations. construction costs often make new hospitals cost prohibitive. the hospital-within-a-hospital can be a means to create additional profit centers and improve the hospital’s image or reputation. by arranging to lease space in a host hospital, the hospital-within-a-hospital can deliver care in an area where it previously did not make financial sense to set up an entire hospital to serve a smaller number of patients. this can expand access to a specific specialty hospital, like a 94 id. 95 id. 96 id. at 42. 2016 573 a hospital-within-a-hospital: good for hospitals, good for patients children’s hospital establishing a hospital-within-a-hospital in a rural host hospital. in the past decade, there was an increase in specialty hospitals,97 which could lead to improvements in care because of the increased competition. some groups are not in favor of an increase in specialty hospitals because general hospitals are unable to capitalize on these specialty cases the way a specialty hospital can because they cannot pick and choose their patients as easily.98 general hospitals may fail to capture revenue for procedures that would help them finance other low-profit cases.99 hospitals across the country are developing centers geared towards specific health concerns and patients.100 this increase in specialty facilities demonstrates a “simple unifying theme behind this multifaceted array of institutions: specialty medicine.”101 of the specialty endeavors, they “may be housed on separate floors within a hospital, be in separate administrative units (inor outpatient) within a hospital, represent organizations within a hospital but with a distinct managerial structure (“hospital within a hospital”), be an entirely separate specialty hospital, or be physician owned.”102 hospitals-within-hospitals are able to capitalize on the demand for specialty medicine. the hospital-within-ahospital arrangement is advantageous for certain hospitals 97 david shactman, specialty hospitals, ambulatory surgery centers, and general hospitals: charting a wise public policy course, 24 health aff. 868, 868 (2005), available at http:// content.healthaffairs.org/content/24/3/868.full.pdf [http://perma.cc/ 89wh-cmu4]. 98 id. 99 id. 100 robert a. berenson et al., specialty-service lines: salvos in the new medical arms race, 25 health aff. w337, w337-w339 (2006), available at http://content.healthaffairs.org/content/25/5/w337.full.pdf [http://perma.cc/k36f-epn9]. 101 id. at w337. 102 id. at w339. http://dx.doi.org/10.1377/hlthaff.24.3.868 http://dx.doi.org/10.1377/hlthaff.25.w337 574 indiana health law review vol. 13:2 because they can “brand” their specialty and then offer their services at a remote location. d. a unique model of "separateness" although maternity units are not one of the care facilities excluded under the prospective payment system, a careful implementation of the “separateness” requirement could allow hospitals to use the hospital-within-a-hospital structure to facilitate delivery of certain types of health care services while protecting catholic hospitals from violating deeply held convictions over permissible and impermissible health care services. compelled to adhere to the ethical and religious directives for catholic health care services, (“ethical and religious directives”), moral guidelines created by the united states conference of catholic bishops, catholic hospitals usually have policies in place to refuse to provide certain services generally considered standard on moral grounds.103 although individual providers practicing at a catholic hospital may bend these rules at the hospital on an individual level (where they would likely be subject to discipline), or maintain separate offices to perform these services, catholic hospitals typically do not offer reproductive services. reproductive services usually include contraception,104 sterilization, abortion and infertility 103 see united states conference of catholic bishops, ethical and religious directives for catholic health care services (5th ed. 2009), available at http://www.usccb.org/issues-and-action/humanlife-and-dignity/health-care/upload/ethical-religious-directivescatholic-health-care-services-fifth-edition-2009.pdf [perma.cc/9pyg5nc5]. 104 lois uttley & ronnie pawelko, no strings attached: public funding of religiously-sponsored hospitals in the united states (2002), available at http://www.mergerwatch.org/storage/pdf-files/ bp_no_strings_hilights.pdf [http://perma.cc/9j9g-ekek]. this prohibition is of particular interest to some advocacy groups who fear that 2016 575 a hospital-within-a-hospital: good for hospitals, good for patients services, and counseling for safe sex.105 there may also be restrictions on a patient’s end of life choices, as the medical team that handles end of life wishes may be required to follow the patient’s wishes only to the extent that the wishes comport with the ethical and religious directives.106 certain treatments derived from embryonic stem cell research, even those accepted in the wider medical community, may also be prohibited.107 this is because according to the ethical and religious directives, the catholic church “cannot approve medical practices that undermine the biological, psychological, and moral bonds on which the strength of marriage and the family depends.”108 there was a sixteen percent increase in the number of catholic hospitals from 2001 to 2011.109 in light of this increase, the hospital-within-a-hospital structure could be an opportunity to better serve the patient population of a geographic area where people only have convenient access to a catholic hospital.110 for example, a catholic health care system that hosts an independent, secular hospital-within-ahospital could provide treatment that the ethical and religious directives do not allow. this would make additional healthcare services available to the local population and quell fears that the increase in catholic hospital systems merging or acquiring secular hospitals will the refusal to administer emergency contraception, even to victims of rape, will place an unfair and uncontrollable burden on the community served by the catholic hospital. 105 id. 106 id. 107 id. 108 united states conference of catholic bishops, supra note 103, at 23. 109 lois uttley, sheila reynertson, lorraine kenny & louise melling, miscarriage of medicine: the growth of catholic hospitals and the threat to reproductive health care 4 (2013), available at http://www.aclu.org/sites/default/files/field_document/growth-of-catholichospitals-2013.pdf [http://perma.cc/2nr4-crku]. 110 see id. 576 indiana health law review vol. 13:2 lead to a reduction in available health care services for a community. this could also be a business opportunity for a hospital to specialize in operating hospitals-within-hospitals in catholic hospitals. of course, catholic hospitals should not be compelled to participate in or endorse a practice that they find morally objectionable. there are many issues with catholic hospital mergers that are outside the scope of this note, but they include first amendment rights for medical staff that do not wish to compromise their moral beliefs by mandates that they provide certain types of treatments; issues with the providers who do not want a different kind of institutional conscience imposed on what they believe is their right to practice medicine as they see fit; and contentions that hospitals that treat medicare and medicaid patients, who may be elderly, disabled, and impoverished, should offer basic care. a few catholic hospitals have created models with similar "separateness" requirements, and one example is a hospital in austin, texas. this hospital used an arrangement that resembled the “hospital within a hospital” requirements, required by 42 c.f.r. § 412.22, to allow a community "safety net" hospital to survive financially while not depriving members of the community of reproductive services like emergency contraception.111 seton, a catholic hospital that the daughters of charity of st. vincent de-paul owned and managed, entered into a public-private partnership lease agreement with brackenridge hospital, owned and operated by the city of austin, texas, where seton leased buildings from brackenridge.112 brackenridge, the city-owned hospital, was in serious financial trouble and was looking for 111 barbra mann wall, conflict and compromise: catholic and public hospital partnerships, 18 nursing hist. rev. 100 (2010), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2886734/pdf/nihms20484 0.pdf [http://perma.cc/q7xk-4ucm]. 112 id. at 100. http://dx.doi.org/10.1891/1062-8061.18.100 2016 577 a hospital-within-a-hospital: good for hospitals, good for patients a lifeline to prevent its seemingly inevitable closure.113 brackenridge hospital played a crucial role in providing health services to community members of limited means, and its closure would have had a detrimental impact on this population.114 the fact that if brackenridge hospital was forced to shut its doors because of its financial situation, the poor would effectively be denied health care because the only other option was a for-profit hospital that would not provide the same amount of charity care led to the acceptance of this arrangement.115 this risk to the poor served as a powerful impetus to come to an arrangement that would allow seton, as a catholic entity, to serve the health care needs of the poor in the community while not compromising the moral principles to which seton was ethically and morally compelled to adhere.116 initially, the terms of the arrangement were organized so that seton, the catholic hospital, never performed and was never directly involved in care that was designated as morally objectionable by the ethical and religious directives, but these reproductive services forbidden by the ethical and religious directives were allowed to take place at brackenridge.117 this type of compromise was in compliance with the ethical and religious directives at the time due to a number of nuances in the arrangement, 113 id. 114 id. 115 see generally id. 116 id. at 101. 117 id. 578 indiana health law review vol. 13:2 including that brackenridge was not deemed a catholic hospital.118 when the ethical and religious directives were later updated to forbid any type of working arrangement with a group that facilitated services the catholic church perceived as intrinsically evil, the hospitals had to adjust the arrangement, again to fulfill their duty to serve the needs of the poor in the community while still adhering to the highlyregarded ethical and religious directives essential to their operation as a catholic hospital .119 seton paid to create a solution that embodied similar characteristics to the hospital-within-a-hospital authorized by statute and allowed the hospital to continue to meet the medical needs of the poor community while maintaining "separateness." they included remodeling a floor of the hospital so that the secular, separately licensed facility could have “its own pharmacy, medical records area, nursing unit, housekeeping, and separate elevator.”120 this floor of the building was where all sterilization and contraceptive services, services the ethical and religious directives does not support or allow on moral grounds, took place.121 the parties involved believed there were sufficient restrictions on contraceptives provided on an emergency basis that it was morally permissible for the catholic hospital to allow the distribution of emergency contraceptives.122 before transferring a woman in need of emergency contraceptives to the hospital-within-a-hospital “secular” floor, the woman had to be tested to ensure she was not ovulating at the time the medication was administered because otherwise the use of contraceptives would be morally impermissible.123 although this arrangement might even surprise some devout catholics as overly permissive, critics of the compromise said the restrictions interfered with and unnecessarily complicated the care female patients received.124 118 id. at 105-106. 119 id. at 109-110. 120 id. at 111. 121 id. at 110. 122 id. 123 id. at 111. 124 id. at 110-11. 2016 579 a hospital-within-a-hospital: good for hospitals, good for patients as the ethical and religious directives tightened to forbid associations and compromises, this type of arrangement became more difficult, but if the ethical and religious directives are ever modified to allow close relationships between secular and catholic health care providers, the hospital-within-a-hospital structure is a novel framework to structure an arrangement through the separateness requirements, basic function, or the fifteen percent rule. burdett care center in troy, new york is another example of a catholic host hospital with a secular “hospitalwithin-a-hospital” that, like brackenridge and seton, embodies the structure of the hospital-within-a-hospital authorized by statute and shows that if separateness can be established to a level where a catholic institution can share space with a hospital engaging in acts the catholic institution believes is morally wrong, surely the statutory requirements are sufficient for operational separateness.125 samaritan hospital’s parent corporation, northeast hospital, engaged in merger discussions with a catholic hospital system, st. peter’s health care services, regarding a merger with st. mary’s hospital.126 initially, there was alarm that the merger would restrict access to reproductive services.127 as a compromise, the new parent corporation of the two new partners was st. peter’s health partners, where 125 lois uttley, et al., merging catholic and non-sectarian hospitals: new york state models for addressing the ethical challenges, 17 n.y. st. b.a. health l.j. 38, 41 (2012), available at http://static1.1.sqspcdn.com/static/f/816571/23042588/1372882137057/m odels+of+catholic-secular+hospitals+mergers+in+nys.pdf?token= 8wf9c2jenxfin8ct4a4olwniuso%3d/ [http://perma.cc/3pxc-j6qq]. 126 id. 127 id. 580 indiana health law review vol. 13:2 “corporate ‘members’ st. peter’s and seton health retain[ed] their identities as catholic facilities and member northeast health (including samaritan hospital) retain[ed] its identity as a non-sectarian health care system.”128 this arrangement resulted in the creation of burdett care center, a “hospitalwithin-a-hospital” on the second floor of samaritan hospital.129 the burdett care center is a fifteen bed maternity hospital that “preserves services that can no longer be offered by samaritan itself, under the terms of the merger: sterilization procedures, birth control and treatment of certain pregnancy emergencies.”130 in line with the separateness requirements, samaritan provided a five million dollar trust to serve as a “financial buffer” and the burdett care center established a different board and different staff than samaritan.131 it should be noted that while a specific hospital board and the bishop of a catholic diocese who controls whether or not the agreement is allowed may agree to a similar arrangement, the strongly held call to respect and protect life means that many catholics may still find these arrangements objectionable and consider them to be an unconscionable compromise. additionally, changes to the ethical and religious directives could bar this type of arrangement as well, and catholic hospitals should not be compelled to arrangements that violate them. for instance, in november of 2014, the u.s. conference of catholic bishops voted to update the ethical and religious directives as they relate to the relationships of catholic hospitals with secular hospitals.132 specifically, this encompasses “matters such as 128 id. 129 id. 130 id. 131 id. 132 nina martin, catholic bishops vote to revise rules for health care partnerships, propublica (nov. 11, 2014, 10:17 am), 2016 581 a hospital-within-a-hospital: good for hospitals, good for patients decisions of hospital administrators regarding possible cooperative arrangements with non-catholic entities; distinctions between formal and material cooperation with evil; and moral decision-making as it applies to joint actions with partners, boards and other bodies.”133 there is speculation that the revisions will most likely make arrangements more difficult and less compromising. regardless, the separateness and the benefits of the hospitalwithin-a-hospital system are a beneficial solution for the merging of catholic and secular hospitals without compromising the types of services offered to women in the community. these secular-catholic arrangements are examples of how two hospitals with different missions can coexist and serve the diverse needs of a community. iv. problems associated with a hospital within-a-hospital a. overbilling fear of hospitals overbilling or double billing for services is a common reason hospitals-within-hospitals are discouraged or disliked by those charged with protecting tax dollars and evaluating the expenditure of american dollars allocated to health care. concerns that an ltch hospital http://www.propublica.org/article/catholic-bishops-weigh-tighteningrules-for-health-care-partnerships [http://perma.cc/t244-37hz]. 133 bishops to vote on proposal to revise ‘ethical and religious directives for catholic health care services’ at november meeting, united states conference of catholic bishops (oct. 27, 2014), http://www.usccb.org/news/2014/14-171.cfm [http://perma.cc/7ztpygll]. 582 indiana health law review vol. 13:2 within-a-hospital can lead to overbilling of medicare resulted in a moratorium for new ltch hospitals.134 in 2006, these concerns were best articulated by herb b. kuhn, then the director of cms, who said at a hearing that nearly half of ltchs were hospitals-within-hospitals, and over a ten-year period the number of ltch hospitals-within-hospitals grew thirty-five percent.135 kuhn contended that while cms acknowledged that the arrangement can benefit patients and generate many operational efficiencies, “[colocation] also leads to patient shifting from one part of a hospital to another, resulting in two medicare payments for what is essentially one episode of patient care.”136 a common perception of the ltch, and the hospitalwithin-a-hospital in general, is that hospitals-withinhospitals create a mutually beneficial arrangement where the hospital-within-a-hospital is able to lease out an acute care hospital’s extra space and empty beds and use the host hospital as a pipeline for patients.137 the argument is that the host hospital “gets a rent-paying tenant for its formerly unused space, and the ltch saves the cost of building a freestanding facility and gets a steady provider of sick people.”138 134 42 c.f.r. § 412.23(e)(6) (2016). “[f]or the period beginning december 29, 2007 and ending december 28, 2012, [ ] a moratorium applies to the establishment and classification of a long-term care hospital [ ] or a long-term care hospital satellite facility . . . .” id. 135 long term acute care hospitals: hearing before the subcomm. on health of the comm. on ways and means, 109th cong. 2 (2006) (statement of director herb b. kuhn, center for medicare management, ctrs. for medicare and medicaid svcs., u.s. dept. of health and human svcs), available at http://www.gpo.gov/fdsys/pkg/chrg-109hhrg30439/ html/chrg-109hhrg30439.htm [http://perma.cc/74ep-nj7f]. 136 id. 137 josh levin, the other katrina hospital mystery, slate (sept. 4, 2009, 7:03 am), http://www.slate.com/articles/news_and_politics/ prescriptions/2009/09/the_other_katrina_hospital_mystery.single.html [http://perma.cc/9xr5-pxd6]. 138 id. 2016 583 a hospital-within-a-hospital: good for hospitals, good for patients in agreement, concerns have been articulated that “because the relationship between long-term care [hospitals-withinhospitals] and their host hospitals is necessarily close, the two institutions could easily work together to circumvent the cost control intent of medicare’s pps payments.” 139 this concern has also been expressed in case law, where there are concerns that the hospital-within-a-hospital arrangement would tempt the acute care host hospital to abuse the system. for example, [a]n acute care hospital that consistently discharges a higher cost patient to a postacute care setting for the purpose of lowering its costs undercuts the foundation of the ipps drg system, which is based on averages. in this circumstance, the hospital would recoup larger payments from the medicare system than is intended under the drg system because the course of acute treatment has not been completed. at the same time, the patient, still under active treatment for an acute illness, will be admitted to a ltch, thereby generating a second admission and medicare payment that would not have taken place but for the fact of colocation.140 139 susan e. cancelosi, fighting medicare fraud in long-term care hospitals-within-hospitals: oig documents ongoing failures while industry groups complain 2 (unpublished), available at http://www.law.uh.edu/healthlaw/perspectives/(sc)ltchwhrev.pdf [http://perma.cc/38vp-k455]. 140 select specialty hosp., 820 f. supp. 2d 13, at 18 (quoting 69 fed. reg. 28196, 28325 (may 18, 2004)). “since 1983, under 42 u.s.c. § 584 indiana health law review vol. 13:2 in this scenario, medicare pays more than the necessary amount to the host hospital for the same patient. a letter from the office of the inspector general indicated that many ltchs have not notified medicare of their co-located status, which will lead to overpayment by medicare.141 a hospitalwithin-a-hospital structure that benefits from the payment system could be bad for taxpayers and may signal that ltchs need to scrutinize their own adherence to the standards set by medicare. however, careful adherence to permissible billing practices and clear guidelines from medicare will help prevent overbilling. b. “separateness” as an impediment to disaster preparedness beyond payment issues with medicare that give rise to concerns about the hospital-within-a-hospital structure, another significant barrier that the hospital-within-ahospital might face is the effectiveness of their plan of action in the event of an emergency. sharing a physical location while the leadership and staff are independent can lead to difficulties. the pressure of an impending emergency situation can bring internal hospital system failures to the surface, sometimes in tragic ways. the events that took place at a hospital in new orleans when the host hospital and hospital 1395ww(d) the medicare program has paid for an acute care hospital's operating costs in furnishing inpatient services to medicare beneficiaries under a prospective payment system (“inpatient pps” or “ipps”), in which payment is made at a predetermined, specific rate for each discharge.” id. at 17. 141 daniel levinson, vulnerabilities in medicare’s interrupted-stay policy for long-term care hospitals, department health & hum. services 19 (june 2014), http://oig.hhs.gov/oei/reports/oei-04-1200490.pdf [http://perma.cc/489r-dlas]. 2016 585 a hospital-within-a-hospital: good for hospitals, good for patients within-a-hospital, failed to work together in a time of severe crisis brought on by hurricane katrina and her aftermath, to illustrate how deadly serious it is for the host hospital and the hospital-within-a-hospital to maintain separate control but also to be aware of emergency plans and coordinate in a permissible manner. in this case, the hospital-within-a-hospital was an ltch where patients were extremely ill and in need of constant lifesustaining treatment, that makes any evacuation more dangerous to the health and safety of the patient and more complicated on a logistical level. when hurricane katrina struck new orleans in late august of 2005, chaos ensued. on sunday, august 28, 2005, hurricane katrina was a category five storm.142 hospitals should have been well-prepared for the destruction that would occur based on warnings from the national oceanic and atmospheric administration, who warned the public that [m]ost of the area will be uninhabitable for weeks . . . perhaps longer. at least one half of well constructed homes will have roof and wall failure. . . . the majority of industrial buildings will become non functional . . . . airborne debris will be widespread and may include heavy items such as household appliances and even light vehicles. . . . persons, pets, and livestock exposed to the winds will face certain death if struck. power outages will last for weeks. . . 142 14 days a timeline, frontline (nov. 25, 2005), http://www.pbs.org/wgbh/pages/frontline/storm/etc/cron.html [http:// perma.cc/ljy6-k54y]. 586 indiana health law review vol. 13:2 water shortages will make human suffering incredible by modern standards.143 the mayor of new orleans at the time, mayor ray nagin, initiated a mandatory evacuation that resulted in 30,000 people placed in emergency shelter at the superdome.144 the superdome was only stocked with enough emergency provisions to feed half the number of people there for three days.145 due to the severity of the storm, emergency workers were unable to respond to people in need of help.146 once the eye of the storm passed through the city, officials were prepared to begin clean-up efforts.147 however, the city was unprepared for the still-rising floodwaters that resulted after the levees that protect the city from flooding broke.148 by wednesday, august 31, officials estimated that eighty percent of the city was under water, there was rampant looting throughout the city by both opportunistic and desperate individuals, and the focus shifted to evacuating the individuals in the superdome.149 lack of coordination between then-governor of louisiana, kathleen blanco, federal emergency management agency (“fema”) director michael brown, and new orleans mayor ray nagin was blamed for the absence of an appropriate and efficient response to the emergency.150 frustrated by what he saw as an inadequate response, mayor nagin inflamed the public after he spoke on a radio show, with disparaging pronouncements on the action officials had taken.151 michael 143 id. 144 id. 145 id. 146 id. 147 id. 148 id. 149 id. 150 id. 151 id. 2016 587 a hospital-within-a-hospital: good for hospitals, good for patients brown, then-fema director, admitted to misleading the public in order to maintain calm, despite the fact that the fema situation update reported that the situation had escalated to the point where, shockingly, [l]aw and order all but broke down in new orleans over the past few days. storm refugees reported being raped, shot and robbed, gangs of teenagers hijacked boats meant to rescue them, and frustrated hurricane victims menaced outmanned law officers. police chief eddie compass admitted even his own officers had taken food and water from stores. officers were walking off the job by the dozens. . . .152 reflecting the significant coordination problems that federal, state and local officials encountered during hurricane katrina, lifecare, a hospital-within-a-hospital, experienced significant difficulties coordinating an evacuation plan with its host hospital that arguably led to patients being euthanized.153 a contributing factor to the difficulties of the evacuation of this hospital was the lack of understanding about how the two separate hospitals should interact.154 lifecare leased the seventh floor at memorial medical center in new orleans, louisiana.155 lifecare, 152 id. 153 sheri fink, the deadly choices at memorial, n.y. times (aug. 25, 2009), http://www.nytimes.com/2009/08/30/magazine/30doctors.html?pagewant ed=all&_r=0 [http://perma.cc/ys7m-3frq]. 154 id. 155 id. 588 indiana health law review vol. 13:2 which adhered to the separateness tenant required of ltchs in the sense that it credentialed its own staff, worked to keep patients who were elderly or incredibly ill alive with technology that some doctors at memorial believed was too drastic for the patient and a waste of resources.156 this attitude that patients on the lifecare floor were “chronically deathbound” contributed to what some experts say was the euthanasia of patients that hospital workers considered too sick to move.157 lifecare was not invited to the discussions that happened among hospital staff over their plan of evacuation when the situation took a turn for the worse.158 lifecare had an incident commander who was responsible for organizing the evacuation of the lifecare patients and had requested that the lifecare patients be included in memorial’s evacuation plans.159 the incident commander was told that memorial would ask their corporate owner, tenet, for permission to include them in memorial’s evacuation plans.160 tenet claims that lifecare workers rejected an offer of evacuation assistance.161 regardless of which side is right, it is clear there was a breakdown in communication among staff and multiple layers of leadership. in response to the fink article, ellen b. griffith, a spokesperson for cms, said that because it was not clear there was a lifecare physician available on the lifecare floor, it “raises questions about whether the lifecare facility really was a separately certified hospital from memorial medical center or was actually functioning as a unit of memorial.”162 this indicates that disregarding the separateness rule can lead to the hospital-within-a-hospital being taken advantage of by host hospital doctors, in addition to contributing to a dangerous silo where communication does not flow freely. 156 id. 157 id. 158 id. 159 id. 160 id. 161 id. 162 levin, supra note 137. 2016 589 a hospital-within-a-hospital: good for hospitals, good for patients although the issues at memorial demonstrate the devastating effects of a hospital-within-a-hospital that lacks structures and protocols for their own patients and a lack of understanding of how the hospital-within-a-hospital and the host hospital need to interact, there are examples of hospitals-within-hospitals that have successfully managed emergency situations. an example of a hospital-within-ahospital that successfully and smoothly handled an emergency evacuation is triumph hospital. triumph hospital is a long term acute care hospital-within-a-hospital whose host at the time was meritcare hospital.163 in the face of dangerous floods as the nearby red river rose, the health care workers were able to act to prevent threats to patient safety.164 when the “evacuation trigger was pulled at meritcare, patients had been ready to roll for hours, [with] baggies of medicines at their bedsides, checklists on their doors, and bar-coded triage bracelets on their wrists whose colors indicated the type of transport required.”165 the chief clinical officer of triumph said she felt like she was “overly prepared,” a sentiment that the officials at memorial likely did not experience.166 the health care providers said that several factors contributed to their success: “flexibility, days 163 sheri fink, disaster preparedness pays off in north dakota, propublica (mar. 31, 2009, 11:52 am), http://www.propublica.org/ article/disaster-preparedness-pays-off-in-north-dakota-20090331 [http://perma.cc/8lyj-2ygj]. 164 id. 165 id. 166 id. 590 indiana health law review vol. 13:2 of advance planning, and strong collaboration between health facilities and local, state and federal government.”167 other external risks besides natural disasters can present challenges to hospitals-within-hospitals. another risk to both the host hospital and the hospital-within-a-hospital is infection control. as evidenced by the 2014 ebola outbreak, infectious diseases can severely impact the health of the community, as well as the public’s perception of community safety.168 appropriate protocols need to be in place to prevent transferring infections from one institution to another. although the events at memorial care center in new orleans show that a poorly organized plan of action in the face of a disaster can have devastating consequences for patients of a hospital-within-a-hospital, this is something that hospitals-within-hospitals should be able to overcome with careful planning. hospitals-within-hospitals should be able to work with their host hospital in a way that does not endanger the safety of patients in emergency situations but also avoiding impermissible acts of control by one hospital over another. during emergencies, hospitals in a community typically collaborate with each other, even if they are bitter rivals every other day of the year. in the event of a catastrophe, hospitals need to be able to handle the “surge” that occurs during emergencies and need “the ability to respond to mass casualty events and adequately care for a sudden influx of patients with common or unusual medical needs.”169 167 id. 168 see 2014 ebola outbreak in west africa, centers for disease control & prevention, http://www.cdc.gov/vhf/ebola/outbreaks/2014west-africa/ [http://perma.cc/p7wy-savx] (last visited feb. 28, 2016). 169 public health emergency preparedness and response, u.s. gov’t accountability off., http://www.gao.gov/key_issues/ public_health_emergency_preparedness_response/issue_summary [http://perma.cc/bh3v-dkdc] (last visited feb. 28, 2016). 2016 591 a hospital-within-a-hospital: good for hospitals, good for patients a community-wide disaster preparedness committee with all hospital stakeholders represented is an innovative solution to the issue. in indiana, hospitals participate in a public-private coalition called managed emergency surge for healthcare coalition, or mesh.170 mesh “creates a forum for healthcare organizations to collaboratively address issues ranging from operational readiness to reimbursement following a catastrophic disaster.”171 mesh “brings the pieces of the emergency healthcare puzzle together.”172 the mesh coalition provides a forum for hospitals to distribute resources as needed and creates centralized “preparedness functions.”173 currently, mesh is comprised of both public and private members and it includes the marion county public health department and other hospitals.174 this type of community-wide collaboration would be ideal because it would help all health care providers in the event of an emergency. the hospital-within-a-hospital should not be considered under the “control” of its host hospital because it is simply a participating member of a community-wide disaster plan. an organization like mesh would alleviate confusion and would serve to prevent catastrophes like the situation that happened with memorial and lifecare. disaster preparedness concerns should not bar the formation of a hospital-within-a-hospital; rather it is another factor to take into consideration when forming a hospital-within-ahospital. 170 see mesh coalition, http://www.meshcoalition.org [http:// perma.cc/h5cu-dsmd] (last visited jan. 29, 2016). 171 marion county ares, http://www.mcinares.org/mesh-coalition [http://perma.cc/5r2w-8sge] (last visited jan. 29, 2016). 172 mesh coalition, supra note 170. 173 justin mast, fostering community: how one indiana community meshed its resources to improve preparedness, trust for am.’s health (june 4, 2015), http://healthyamericans.org/health-issues/ prevention_story/mesh-community-resilience/ [http://perma.cc/96g5cmte]; see mesh coalition, supra note 170. 174 mesh coalition, supra note 170. 592 indiana health law review vol. 13:2 v. conclusion the hospital-within-a-hospital is a structure that provides opportunities for the host hospital that benefits both hospitals involved and the patients in the geographic area. the hospital-within-a-hospital benefits outweigh the operational difficulties in ensuring adherence to the requirements of the statute, especially the more complicated “separateness” requirement, in addition to concerns about violating the stark law or aks. reduced readmissions through better transitional care benefits both the patient who must endure the difficulty of additional time in the hospital and the hospital that will suffer from financial penalties for excessive readmissions. reduced readmission allows the host hospital to avoid readmission penalties from medicare. the hospital-within-a-hospital is a means for host hospitals to achieve both financial and quality goals, despite payment issues and operational difficulties that arise due to cms constraints on the hospital-within-a-hospital. physicians could use the hospital-within-a-hospital structure to maintain their power and autonomy during an era of physician practices being purchased by large health systems. catholic hospitals, which are growing in number as regulator pressure drives increases in hospital consolidations and mergers, could authorize an arrangement with a hospital-within-a hospital to preserve certain patient services that would otherwise be limited. this could also be effective for other religious hospitals that are guided by moral principles that forbid offering certain treatments. the benefits to patients in terms of convenience and cost efficiency outweigh any potential risks that a hospitalwithin-a-hospital will take advantage of the payment systems and churn bills. disaster preparedness arrangements, like mesh, will alleviate concerns that host hospitals will cross into dangerous territory of making life or death decisions for the hospital-within-a-hospital’s patients. mesh would also alleviate issues of impermissible lack of separation if the host hospital and the hospital-within-a-hospital need to work together to coordinate their emergency response plans. overall, the separateness requirements of the host hospital and the hospital-within-a-hospital ensure that this 2016 593 a hospital-within-a-hospital: good for hospitals, good for patients system will not result in unethical arrangements. the chief medical officer of the host hospital is separate from the hospital-within-a-hospital as well as the medical staff. the ceo is not permitted to be employed by the hospital-withinthe-hospital. these safeguards should allow for the creation of more of these entities to better serve patients and offer more diverse services in areas that need them the most. big data analytics: what can go wrong sharona hoffman * abstract: it is not uncommon to read that long-held beliefs about medical treatments have been dislodged by new studies. for example, there is now doubt as to whether women should undergo annual mammograms, previously a cornerstone of cancer screening. hormone replacement therapy for menopausal women, once considered highly suspect in light of worrisome research findings, is now being reconsidered as a beneficial therapy. these reversals trouble and confuse many americans. this article explores why medical research findings can be erroneous and what can go wrong in the process of designing and conducting research studies. it provides readers with essential analytical tools and scientific vocabulary. the challenges of medical research include data quality deficiencies; selection, confounding, measurement, and confirmation biases; inadequate sample sizes; sampling errors; effect modifiers; and causal interactions, among others. all of these can cause researchers to mistake mere associations for causal relationships and to reach conclusions that are invalid and cannot be replicated in subsequent studies. erroneous research findings can mislead legislators, regulators, and lawyers who use them for purposes of policy-making or litigation. thus, understanding the pitfalls of big data analysis is important not only for scientists but also for anyone working with or reading about research studies, that is, for attorneys, health policy professionals, and the public at large. i. introduction big data analysis can be a valuable addition to the research toolkit and fill many knowledge gaps. it is unclear, however, whether the proliferation of1 research endeavors will consistently advance scientific truths. big data research is relevant to health law and policy because it can be used in litigation by both plaintiffs and defendants. based on studies that reveal2 * edgar a. hahn professor of law and professor of bioethics, co-director of lawmedicine center, case western reserve university school of law; b.a., wellesley college; j.d., harvard law school; ll.m. in health law, university of houston; s.j.d. in health law, case western reserve university. this article is based in part on sharona hoffman & andy podgurski, the use and misuse of biomedical data: is bigger really better?, 39 am. j. l. & med. 497 (2013) and sharona hoffman, medical big data quality and analysis concerns, in electronic health records and medical big data: law and policy (cambridge u. press 2016). 1. sharona hoffman & andy podgurski, the use and misuse of biomedical data: is bigger really better?, 39 am. j. l. & med. 497, 499 (2013). 2. david l. faigman et al., modern scientific evidence: standards, statistics, and research methods 338-42 (student ed., 2008); bernard marr, how big data is disrupting law firms and the legal profession, forbes (jan. 20, 2016), https://www.forbes.com/ sites/bernardmarr/2016/01/20/how-big-data-is-disrupting-law-firms-and-the-legalprofession/#328c59227c23 [https://perma.cc/4mxa-n45s] (stating that lawyers “are starting to http://doi.org/10.18060/3911.0048 228 indiana health law review [vol. 15:227 statistical associations between illnesses and exposure to certain substances, plaintiffs may file tort cases against product manufacturers. for their part, defendants may use different studies to undermine plaintiffs’ claims and argue that something other than their products caused the conditions in question.3 in addition, responsible legislators and policy-makers often rely on research findings for purposes of formulating laws, regulations, and policies. when the studies they review are wrong, government authorities can impose needless burdens on the public or, worse yet, cause harm. 4 two notorious examples illustrate the potential influence of erroneous research outcomes. a 1998 study published in the prestigious journal, lancet, suggested that the measles, mumps, rubella (mmr) vaccination caused autism.5 while the study was later retracted, the belief that vaccinations can lead to6 autism gained traction and still needs to be explicitly rebutted on the centers for7 disease control and prevention’s website. it is not inconceivable that such a8 study could have convinced state legislatures to relax vaccination requirements before it was disavowed. in 2009, the journal of psychiatric research published a study that claimed to have discovered a causal link between abortion and psychiatric disorders. the9 researchers reviewed “national data sets with reproductive history and mental health variables” to formulate their findings. abortion foes widely cited the10 study, and several states in fact enacted laws requiring women who want11 think about how this technology could be applied to the fundamental research and case preparation which is the core of their job.”). 3. faigman et al., supra note 2, at 339-40 (explaining that epidemiological evidence has already played an important role in many mass tort cases); steve c. gold, the more we know, the less intelligent we are? – how genomic information should, and should not, change toxic tort causation doctrine, 34 harv. envtl. l. rev. 369, 412-17 (2010) (discussing genes and other toxins as alternate causes of plaintiffs’ injuries). 4. hoffman & podgurski, supra note 1, at 500-01. 5. andrew j. wakefield et al., ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, 351 lancet 637, 641 (1998). 6. simon h. murch et al., retraction of an interpretation, 363 lancet 750, 750 (2004). 7. jack healy & michael paulson, vaccine critics turn defensive over measles, n.y. times (jan. 30, 2015), https://www.nytimes.com/2015/01/31/us/vaccine-critics-turn-defensiveover-measles.html?mcubz=0 [https://perma.cc/zj32-dwc7]. 8. measles, mumps, and rubella (mmr) vaccine safety studies, cdc, http://www .cdc .gov/ vaccinesafety/ vaccines/ mmr/ mmr.html [https://perma.cc/ft5d-hj54] (last updated aug. 28, 2015). 9. priscilla k. coleman et al., induced abortion and anxiety, mood, and substance abuse disorders: isolating the effects of abortion in the national comorbidity survey, 43 j. psychol. res. 770, 773 (2009). 10. id. 11. sharon begley, journal disavows study touted by u.s. abortion foes, reuters (mar. 7, 2012, 3:15 pm), http://www.reuters.com/article/2012/03/07/us-usa-abortion-psychiatryidustre8261ud20120307 [https://perma.cc/t2wq-u2c8] (stating that the study had been 2018] big data analytics: what can go wrong 229 abortions to receive counseling that warns them of potential long-term mental health problems. the study was discredited in 2012 when scientists found that12 its design was deeply flawed. the original researchers did not compare women13 with unplanned pregnancies who had abortions to those who did not and failed to focus only on mental health problems that manifested after abortions. thus,14 legislative initiatives were based on invalid findings. there are many other examples of research findings that have gained extensive media coverage, but all too frequently, they are later questioned or contradicted. these reversals can be perplexing and frustrating. a 2010 article15 16 in the atlantic bemoaned the phenomenon of conflicting, highly publicized research outcomes: and they sometimes make headlines, as when in recent years large studies or growing consensuses of researchers concluded that mammograms, colonoscopies, and psa tests are far less useful cancerdetection tools than we had been told; or when widely prescribed antidepressants such as prozac, zoloft, and paxil were revealed to be no more effective than a placebo for most cases of depression; or when we learned that staying out of the sun entirely can actually increase cancer risks; or when we were told that the advice to drink lots of water during intense exercise was potentially fatal; or when, last april, we were informed that taking fish oil, exercising, and doing puzzles doesn’t really help fend off alzheimer’s disease, as long claimed. peer-reviewed studies have come to opposite conclusions on whether using cell phones can cause brain cancer, whether sleeping more than eight hours a night is healthful or dangerous, whether taking aspirin every day is more likely to save your life or cut it short, and whether routine angioplasty works better than pills to unclog heart arteries.17 this article explores why medical research findings can be erroneous and “widely cited by legislators and advocates to argue that abortion raises a woman's risk of mental illness and to push for laws requiring providers” to inform women of this danger). 12. counseling and waiting periods for abortion, guttmacher inst.: state policies in brief (2018), http://www.guttmacher.org/statecenter/spibs/spib_mwpa.pdf [https://perma.cc/ 49by-rl9a]. 13. ronald c. kessler & alan f. schatzberg, commentary on abortion studies of steinberg and finer (social science & medicine 2011; 72:72–82) and coleman (journal of psychiatric research 2009;43:770–6 & journal of psychiatric research 2011;45:1133–4), 46 j. psychol. res. 410, 410-411 (2012). 14. id. at 410. 15. david h. freedman, lies, damned lies, and medical science, the atlantic (nov. 2010), https://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medicalscience/308269/ [https://perma.cc/k9lg-ygne]. 16. rebekah h. nagler, adverse outcomes associated with media exposure to contradictory nutrition messages, 19 j. health comm. 24, 24 (2014). 17. freedman, supra note 15. 230 indiana health law review [vol. 15:227 what can go wrong in the process of designing and conducting research studies. it provides readers with essential analytical tools and scientific vocabulary. understanding the pitfalls of big data analysis is important not only for scientists but also for anyone working with or reading about research studies, that is, for attorneys, health policy professionals, and the public at large. big data analysis can face many challenges. first, as discussed in part ii, the data that researchers review can be fraught with errors, incomplete, fragmented, or otherwise flawed. second, part iii analyzes a variety of biases that can distort18 research findings, including selection bias, confounding bias, measurement bias, and confirmation bias. part iv explores additional research obstacles. for19 20 example, sample sizes can be too small to produce reliable research results, sampling errors may exist, treatment effects can vary between individuals because of effect modifiers, and researchers might fail to discover causal interactions among multiple causal factors. as explained in part v, all of these problems can21 cause researchers to mistake mere associations for causation and to reach outcomes that cannot be replicated and confirmed in subsequent studies. thus, research errors and debunked studies are common phenomena. finally, part vi concludes. ii. data quality medical big data analysis often draws upon electronic health records (ehrs). a key hurdle to conducting record-based research is that existing ehrs often contain errors, are incomplete, or suffer from other shortcomings. the information in ehrs is initially collected for medical treatment and billing purposes, so it may be ill-suited for research. moreover, data are often22 contaminated by a myriad of inaccuracies that can compromise research outcomes. though improved data-capture technology may remedy many shortcomings in the future, these deficiencies should be a significant concern to23 contemporary researchers. this section discusses a number of potential data quality problems. a. data can be entered incorrectly clinicians inputting ehr data can mistype words and numbers or copy and paste information from a prior date into a current visit’s entry in order to save time without editing and updating it appropriately. they can also select the wrong ehr codes and menu items or be forced to choose among diagnosis or treatment codes that are not specific or detailed enough to describe the patient’s condition 18. see infra part ii. 19. see infra part iii. 20. see infra part iv. 21. see infra part iv. 22. hoffman & podgurski, supra note 1, at 518-20. 23. id. at 527-30. 2018] big data analytics: what can go wrong 231 accurately. 24 some research suggests that error rates in ehrs are considerably higher than they were in paper records. in one study, researchers examined progress notes25 made between august 2011 and july 2013 at a michigan hospital that implemented an ehr system in 2012. they found an error rate of 24.4 percent26 in ehrs compared to a 4.4 percent error rate in paper records. it is noteworthy,27 however, that the study was conducted when the ehr system was first adopted and staff had to learn the new technology. moreover, the researchers found that28 medical residents, who are presumably more tech-savvy than the prior generation of physicians, had far fewer errors and omissions than their older colleagues, so that error rates might decline appreciably in the future. it is also significant that29 ehrs have largely eliminated the serious problem of illegible handwriting in medical records, unless their contents are transcribed from handwritten notes.30 data inaccuracies can distort research outcomes. even a small error rate, as low as one to five percent, can significantly impact estimates of mortality and adverse events. as incidents of hacking and cybercrimes proliferate, data31 analysts also cannot ignore the possibility that hackers will access ehr medical databases and purposefully alter and taint them.32 24. sharona hoffman & andy podgurski, e-health hazards: provider liability and electronic health record systems, 24 berkeley tech. l. j. 1523, 1544-45 (2009) (discussing input errors); taxiarchis botsis et al., secondary use of ehr: data quality issues and informatics opportunities, amia summits translational sci. proc. 1, 3 (2010); jessica s. ancker et al., root causes underlying challenges to secondary use of data, amia ann. symp. proc. archive 57, 61 (2011); hoffman & podgurski, supra note 1 at 518-20 (discussing coding); fouzia f. ozair, ethical issues in electronic health records: a general overview, 6 persp. clinical res. 73, 7576 (apr-jun 2015). 25. jack mccarthy, doctors make more note-taking mistakes with ehrs than paper records, jamia study finds, healthcare it news (july 8, 2016, 7:58 am), http://www. healthcareitnews.com/news/doctors-make-more-note-taking-mistakes-ehrs-paper-records-jamiastudy-finds [https://perma.cc/w8wg-55ku]. 26. id. 27. id. 28. id. 29. id. (noting that the error rates were 5.3% versus 17.3%, and the omission rates were 16.8% versus 33.9%). 30. win phillips & yang gong, developing a nomenclature for emr errors: proceedings of the 13th international conference on human-computer interaction. part iv: interacting in various application domains 587, 589, 591 (julie a. jacko ed., 2009). 31. george hripcsak et al., bias associated with mining electronic health records, 6 j. biomed. discovery & collaboration 48, 52 (2011); steve gallivan & christina pagel, modelling of errors in databases, 11 health care mgmt. sci. 35, 39 (2008); christina pagel & steve gallivan, exploring potential consequences on mortality estimates of errors in clinical databases, 20 ima j. mgmt. mathematics 385, 391 (2009). 32. sander greenland, multiple bias modelling for analysis of observational data, 168 j. 232 indiana health law review [vol. 15:227 b. data can be incomplete or fragmented if ehr data are incomplete or fragmented among several different records, data analysis will be unreliable. researchers may often find that ehrs do not include all of the information they need for their studies. clinicians collect data33 for treatment and billing purposes and thus they generally do not have research studies in mind. for example, a review of ehr data from the new york-34 presbyterian hospital clinical data warehouse revealed that when patients died of pneumonia in the emergency room, clinicians “spent little time documenting symptoms so that in the electronic health record, the patient appeared to be healthy other than the death.” thus, researchers may find these records to be35 relatively unilluminating and a poor fit for research. data concerning treatment outcomes are particularly likely to be missing because doctors and hospitals often do not follow up with patients. for example,36 a patient who visits an emergency room for a few hours and is discharged may choose not to seek further care or may later go to a doctor with a different ehr system so that the hospital record provides no evidence of how the individual ultimately fared. the absence of information could mean that the emergency room treatment cured the patient or, by contrast, that she did not improve or even deteriorated and sought care elsewhere. data fragmentation often exists because different facilities have ehr systems that are not interoperable. interoperability is “the ability of different information37 technology systems and software applications to communicate, to exchange data accurately, effectively, and consistently, and to use the information that has been exchanged.” patients who are treated at multiple medical centers may have their38 records divided among different ehr systems so that their record cannot easily be put together into an integrated whole. ehr fragmentation is a serious39 royal stat. soc’y: series a 267, 267-68 (2005); craig h. mallinckrodt et al., assessing and interpreting treatment effects in longitudinal clinical trials with missing data, 53 biol. psych. 754, 755 (2003). 33. craig newgard et al., electronic versus manual data processing: evaluating the use of electronic health records in out-of-hospital clinical research, 19 acad. emergency med. 217, 224 (2012). 34. m. alan brookhart et al., confounding control in healthcare database research challenges and potential approaches, 48 (suppl 6) med. care s114, s115 (2010). 35. hripcsak et al., supra note 31, at 50. 36. newgard et al., supra note 33, at 225. 37. julia adler-milstein, moving past the ehr interoperability blame game, nejm catalyst (july 18, 2017), http://catalyst.nejm.org/ehr-interoperability-blame-game/ [https:// perma.cc/lgf7-d9yw]. 38. kevin heubusch, interoperability: what it means, why it matters, 77 ahima 26 (jan. 2006), http://library.ahima.org/doc?oid=60942#.wzxngvggm2w [https://perma.cc/9c8ggyf4]. 39. botsis et al., supra note 24, at 4 (stating that the ehr system that was mined for purposes 2018] big data analytics: what can go wrong 233 obstacle for research because analysts looking at records from a particular institution or database see only pieces of patients’ records, and key medical information may be missing. furthermore, researchers who examine de-identified records from multiple facilities may mistake the records of a single patient for records of several different individuals. c. data can be difficult to extract and lack harmonization as other scholars have noted, “[t]he realities of doing research across different institutions using the ehr, even when working with sites that have an ehr from the same vendor, are daunting.” different entities may use different40 versions of ehrs that collect data in different ways. entities may customize their ehrs to change menu items or terminology, and health care providers have different data documentation policies and habits. these problems and others can41 lead to a lack of semantic harmonization that adversely affects the usability of records for research purposes. semantic harmonization is “the process of collating … data into a singular consistent logical view” so that data are not subject to different interpretations.42 for example, clinicians may be able to choose among a variety of fields in which to document a particular detail, so that researchers expecting to find it in one field may be confused and miss it altogether. likewise, different medical offices use terms, phrases, and abbreviations differently. to illustrate, the abbreviation “ms” can mean “mitral stenosis,” “multiple sclerosis,” “morphine sulfate,” or “magnesium sulfate.” therefore, a reader looking at records from43 different sources might be unable to understand what “ms” means in a particular instance. 44 another challenge is free text narrative in ehrs. ehr systems allow users to enter both coded information in structured fields and natural-language free text of the study did not contain records of patients who were transferred to dedicated cancer centers because of the severity of their disease or who had initially been treated elsewhere). 40. kathryn h. bowles et al., conducting research using the electronic health record across multi-hospital systems: semantic harmonization implications for administrators, 43 j. nursing admin. 355, 356 (2013). 41. id. 42. james a. cunningham et al., nine principles of semantic harmonization, 2016 amia ann. symp. proc. archive 451, 451 (2016). 43. christopher g. chute, medical concept representation, in medical informatics: knowledge management and data mining in biomedicine 170 tbl.6-1 (hsinchun chen et al. eds., 2005). 44. see the clinical cancer genome task team of the global alliance for genomics and health, sharing clinical and genomic data on cancer–the need for global solutions, 376 new. eng. j. med. 2006, 2006 (2017) (stating that “[i]ncompatible data formats and a shortage of interoperable data-harmonizing informatics tools also compromise researchers’ ability to mine multiple data sets” as does “the absence of a single standardized cancer ontology (a machinereadable set of defined descriptors of clinical manifestations)”). 234 indiana health law review [vol. 15:227 notes about patients. important information may appear in free text rather than45 in the structured fields, and information written in narrative form is much more difficult to extract accurately from ehrs for research purposes. as an example,46 a patient’s worsening asthma may be linked to smoking, but researchers may be unaware of this connection if exacerbated asthma is coded, but smoking history is described only in free-text clinical notes. similarly, clinicians may record47 family histories or details about adverse reactions to drugs in narrative form.48 experts may employ natural-language processing tools to extract data from freetext narrative, but these techniques are still developing and are often imperfect.49 diagnoses, measurements or medical histories that are not standardized or are inaccessible because they are not available in structured form, can significantly hinder research efforts. similarly, medical vocabulary that is not harmonized50 may cause analysts to misconstrue or be unable to understand medical records. d. data can be distorted by software glitches defects in software that is used in ehr systems or is used for data analysis may also generate troubling errors. this is particularly likely when scientists or51 their assistants develop complex software without consulting skilled software developers. inexperienced programmers are likely to create incorrect software52 45. s. trent rosenbloom et al., data from clinical notes: a perspective on the tension between structure and flexible documentation, 18 j. am. med. informatics ass’n 181, 181-82 (2011). 46. the clinical cancer genome task team of the global alliance for genomics and health, supra note 44, at 2006 (noting the “lack of effective methods for extracting data from electronic health records”); hilary townsend, natural language processing and clinical outcomes: the promise and progress of nlp for improved care, 84 ahima 44, 44-45 (mar. 2013), http://library.ahima.org/doc?oid=106198#.wo21_qjwa70 [https://perma.cc/b47v-rvwt]. 47. naren ramakrishnan et al., mining electronic health records, 43 computer 95, 97 (2010). 48. isaac s. kohane, using electronic health records to drive discovery in disease genomics, 12 nature rev. gen. 417, 420 (2011). 49. mike miliard, ehr natural language processing isn't perfect, but it’s really useful, healthcare it news (may 18, 2017), http://www.healthcareitnews.com/news/ehr-naturallanguage-processing-isnt-perfect-its-really-useful-tool [http://perma.cc/z46t-vyrs]. 50. andrea l. benin et al., how good are the data? feasible approach to validation of metrics of quality derived from an outpatient electronic health record, 26 am. j. med. quality 441, 441 (2011). 51. mi ok kim et al., problems with health information technology and their effects on care delivery and patient outcomes: a systematic review, 24 j. am. med. informatics ass’n, 246, 250-51 (2017). 52. rebecca sanders & diane kelly, dealing with risk in scientific software development, 25 ieee software 21, 27 (2008); diane f. kelly, a software chasm: software engineering and scientific computing, 24 ieee software 118, 118-20 (2007); les hatton, the chimera of software quality, 40 computer 104, 104 (2007). 2018] big data analytics: what can go wrong 235 and then test it inadequately. however, commercially developed medical53 research software is not immune to software glitches. ideally, scientists should54 closely collaborate with software experts to develop and thoroughly validate software for medical research. iii. the problem of biases even without data blemishes and software defects, analyzing data and drawing correct causal inferences can be extremely challenging. this section analyzes problems of bias affecting big data studies, in particular, selection bias, confounding bias, measurement bias, and confirmation bias. anyone conducting research or interpreting its results must have a deep understanding of these concepts. a. selection bias selection bias relates to the way in which data subjects are selected for study and generally occurs when selection is not randomized. selection bias may arise55 if individuals have the opportunity to opt out of being included in a database or clinical study. the subset of individuals that remain may not be representative56 of the patient population of interest because people of a particular sex, ancestry, or socioeconomic group opted out disproportionately. selection bias can skew57 assessments of measures such as disease prevalence or exposure risk because the study’s conclusions differ systematically from the true values of these measures for the target population. that is, the researchers’ findings will not be generalizable from the study’s particular subjects to the larger population about which analysts wish to draw conclusions.58 53. kelly, a software chasm, supra note 52, at 118. 54. sanders & kelly, supra note 52, at 25; nicole k. henderson-maclennan et al., pathway analysis software: annotation errors and solutions, 101 molecular genetics & metabolism 134, 137-38 (2010). 55. what researchers mean by . . . selection bias, inst. for work & health, https://www.iwh.on.ca/wrmb/selection-bias [https://perma.cc/l355-v84m] (last visited aug. 18, 2017). 56. kenneth j. rothman et al., modern epidemiology 136 (2008); david l. faigman et al., modern scientific evidence: the law and science of expert testimony §5:16 (2011). 57. sharyl j. nass et al., beyond the hipaa privacy rule: enhancing privacy, improving health through research 209 (2009); franklin g. miller, research on medical records without informed consent, 36 j. l. med. & ethics 560, 560 (2008). 58. herbert i. weisberg, bias and causation: models and judgment for valid comparisons 93-94 (2010). 236 indiana health law review [vol. 15:227 b. confounding bias confounding bias can be a significant problem in causal effect studies.59 causal effect studies typically seek to measure a particular treatment’s average beneficial effect on patients or a particular exposure’s average harmful effect on individuals. confounding occurs when there is a common cause of the treatment/exposure variable and the outcome variable. 60 to illustrate confounding, i offer the following hypothetical. assume a physician chooses among different treatment options based on the severity or duration of a patient’s disease, and these factors also influence the outcome of treatment. thus, patients at a later stage of illness receive treatment a and those61 at an earlier stage receive treatment b. at the same time, sicker patients, as a general matter, will not respond as well as healthier patients to treatments because they are frailer or their conditions are more complicated. unless researchers appropriately adjust for the disease stage factor, called a “confounding variable” or “confounder,” during statistical data analysis, the confounder may produce a false association between the treatment variable and the outcome variable, which will distort findings regarding the causal effects of treatments. in other words, researchers’ conclusions regarding how effective the two medications are may be wrong because of the confounding variable: the illness severity of patients receiving the different therapies. treatment a may appear to be inferior to treatment b not because it actually is less effective but because the patients receiving treatment a are in a late stage of the disease and would not thrive no matter what therapy was administered. socioeconomic factors and patient lifestyle choices may also constitute confounders. financially disadvantaged (and underinsured) individuals may select less expensive treatments, even if those are not the best choices for them, because those are the only affordable options. poverty may also separately lead to ill health, e.g. because of poor nutrition, stress, and lack of leisure time for exercise. on the flip side, the benefits of preventive care, such as cholesterollowering medication, might appear to be greater than they truly are because health-conscious individuals who seek the intervention also take care of themselves with exercise, low-fat diets, and other health-promoting behaviors. thus, these patients’ impressive outcomes are associated with a multitude of factors rather than solely with the preventive measure.62 analysts must strive to ascertain, accurately measure, and adjust for all potential confounding variables in order to reduce or eliminate confounding 59. sander greenland, quantifying biases in causal models: classical confounding vs. collider-stratification bias, 14 epidemiology 300, 306 (2003). 60. miguel a. hernan et al., a structural approach to selection bias, 15 epidemiology 615, 618 (2004). 61. bruce m. psaty & david s. siscovick, minimizing bias due to confounding by indication in comparative effectiveness research, 304 j. am. med. ass’n 897, 897 (2010). 62. brookhart et al., supra note 34, at s115. 2018] big data analytics: what can go wrong 237 bias. this is no simple task in medical studies because it is often very difficult63 to discover which variables are potential confounders. medical care often depends on a patchwork of factors relating to the patients’ health care facilities, health insurance, and clinicians, and to the character and circumstances of the patients themselves, so that various influences remain hidden or obscured. 64 in clinical studies, researchers ideally randomize treatment assignment to65 subjects in order to prevent confounding. thus, in my hypothetical, both66 treatment a and treatment b would be given to patients all along the disease severity spectrum to determine their efficacy regardless of disease stage. by contrast, in a record-based study (also called an observational study), analysts cannot control treatment assignment, because the treatments have already been given and recorded in patients’ medical files. researchers must, therefore, strive to identify and obtain the values of confounding variables and adjust for them during data analysis. 67 c. measurement bias study results can be further compromised by measurement biases arising from errors in measurement and data collection. measuring devices might not be calibrated properly or might not be sensitive enough to detect small differences in relevant variables. biological samples might be stored for different lengths68 of time or in different conditions, which can cause measurement bias when they are analyzed. to the extent that research is based on patients’ own accounts and69 memories, outcomes might be distorted because subjects’ responses are influenced by the questioners’ skills, patience, and apparent sympathy or by how important and relevant patients perceive the study’s topic to be. in addition,70 patients’ memories may be impaired, or they may lie in response to questions that they find to be uncomfortable or embarrassing. for example, a study of patients’ use of opioid pain medication may have to 63. rothman et al. supra note 56, at 58. 64. brookhart et al., supra note 34, at s114. 65. in clinical studies, investigators conduct experiments using human subjects. by contrast, observational studies involve review of existing records rather than controlled experiments. sharona hoffman & andy podgurski, balancing privacy, autonomy, and scientific needs in electronic health records research, 65 smu l. rev. 85, 98-102 (2012) (contrasting clinical trials and observational studies) https://ssrn.com/abstract=1923187 [https://perma.cc/9x4w-766q]. 66. jaclyn l.f. bosco et al., a most stubborn bias: no adjustment method fully resolves confounding by indication in observational studies, 63 j. clinical epidemiology 64, 64 (2010) (explaining that “confounding is best controlled by a randomized design”). 67. id. at 64-65. 68. gael p. hammer et al., avoiding bias in observational studies, 106 deutsches ärzteblatt int’l 664, 665 (2009), https://www.aerzteblatt.de/int/archive/article?id=66288& src=search [https://perma.cc/6ruq-bxan]. 69. id. at 665. 70. id. 238 indiana health law review [vol. 15:227 rely on patients’ own reports concerning how many pills they took each day. this is because prescription records will only reveal to researchers how many prescriptions were filled, not how many pills were ingested and how often. yet, patients who are in severe pain may not record or recall the details of their medication intake. in addition, in light of extensive publicity regarding the opioid crisis, individuals may tend to under-estimate or under-report the amount of71 medication they took because they do not want to be considered to be opioid addicts. in fact, the treatment or outcome itself can affect measurement errors. one72 of the side effects of opioid use is cognitive impairment. thus, in the above73 example, patients may misremember how much medication they took in part because the opioids themselves caused them to suffer cognitive deficits. d. confirmation bias confirmation bias can be defined as “an agent’s tendency to seek, interpret and use evidence in a manner biased toward confirming her existing beliefs or hypotheses.” medical researchers are under significant pressure to obtain grant74 funding and publications. academics thus undertake projects with particular75 results in mind, fervently hoping for dramatic findings and headline-grabbing outcomes. these goals, which some consider to be conflicts of interest, can lead76 analysts to make intentional or unconscious errors such as manipulating data, distorting results, or making stronger claims than the true findings justify.77 confirmation bias is also at play when researchers return time and again to a database, testing and retesting data in order to find publishable results. if initial results are not satisfactory, they look for other associations until one emerges.78 71. see, e.g., maya salam, the opioid epidemic: a crisis years in the making, n.y. times, (oct. 26, 2017), https://www.nytimes.com/2017/10/26/us/opioid-crisis-public-healthemergency.html?_r=0 [https://perma.cc/2388-afq8]. 72. rothman et al., supra note 56, at 137-38. 73. donald teater, nat’l safety council, the psychological and physical side effects of pain medications 3 (2017), http://www.nsc.org/rxdrugoverdosedocuments/ 900006497-adv-rx-side-effects-whitepaper.pdf [https://perma.cc/5q79-zy3y]. 74. gary charness & chetan dave, confirmation bias with motivated beliefs, 104 games and econ. behav. 1, 1 (2017). 75. freedman, supra note 15. 76. id. see also sridharan kannan & sivaramakrishnan gowri, contradicting/negative results in clinical research: why (do we get these)? why not (get these published)? where (to publish)?, 5 persp. clinical res. 151, 151 (2014). 77. freedman, supra note 15; alok jha, false positives: fraud and misconduct are threatening scientific research, the guardian (sept. 13, 2012), https://www.theguardian.com/ science/2012/sep/13/scientific-research-fraud-bad-practice [https://perma.cc/7zwv-z4qb]. 78. freedman, supra note 15 (stating that researchers “run everything through the mill, one at a time, and they start finding associations, and eventually conclude that vitamin x lowers the risk of cancer y, or this food helps with the risk of that disease.”). 2018] big data analytics: what can go wrong 239 experts caution researchers who are conducting subgroup analysis that they should develop a small number of hypotheses a priori, before beginning their study. by contrast, testing a large number of subgroup hypotheses, especially79 those developed post hoc, is likely to reveal spurious subgroup differences. for80 example, in one instance, a randomized controlled trial (“rct”) of a treatment for septic patients failed to show that the therapy had a statistically significant81 benefit. a subgroup analysis, however, seemed to demonstrate that the treatment82 was effective for individuals with a particular type of infection. yet, a later,83 large rct failed to reproduce the subgroup result and proved the positive conclusion to be false. the root of the problem was likely that the researchers’84 initial, erroneous subgroup analysis was one of fifteen subgroup hypotheses that they tested. one expert explains the issue as follows: “the odds are that in any large database … there will be a few apparent connections that are in fact merely flukes, not real health effects—it’s a bit like combing through long, random strings of letters and claiming there’s an important message in any words that happen to turn up.”85 iv. other data analysis pitfalls this section focuses on several additional potential research errors. these consist of using a sample size that is too small, ignoring effect modifiers, and disregarding causal interactions. a. sample size researchers must ensure that their sample size is large enough to yield credible results. sample size affects statistical power, that is, “the probability86 that a statistical test will indicate a significant difference when there truly is one.” if the sample size is too small, it is more likely that any observed87 79. xin sun et al., how to use a subgroup analysis: users’ guides to the medical literature, 311 jama 405, 408 (2014) (explaining that subgroup analysis is designed to identify groups of patients that “respond differently to treatment than other groups.”). 80. id. at 408. 81. definition of sepsis, sepsis all. (last visited august 24, 2017), http://www.sepsis.org/ sepsis/definition/ [https://perma.cc/ht9g-p2zt] (defining sepsis as “the body’s overwhelming and life-threatening response to infection that can lead to tissue damage, organ failure, and death.”). 82. xin sun et al., supra note 79, at 408 (stating that the treatment was platelet-activating factor receptor antagonist). 83. id. (stating that the subgroup was individuals with gram-negative bacterial infection). 84. id. 85. freedman, supra note 15. 86. david jean biau et al., statistics in brief: the importance of sample size in the planning and interpretation of medical research, 466 clinical orthopedics & related res. 2282, 2283 (2008). 87. john eng, sample size estimation: how many individuals should be studied?, 227 radiology 309, 310 (2003). 240 indiana health law review [vol. 15:227 differences among subgroups (or other findings) are false and attributable purely to chance. for example, assume that a medication causes severe nausea and88 vomiting for one in ten patients. if researchers look at only ten medical records, it is very possible that they will encounter only patients who tolerated the drug well and will wrongly conclude that the drug does not cause adverse side effects for anyone who takes it. determining the correct sample size for a particular study is a complicated matter, and it behooves analysts to consult statisticians. sample size can be89 particularly challenging for studies targeting rare diseases or rare genetic variations. however, anyone relying on research outcomes for medical or health90 policy purposes should know to scrutinize sample size and question studies that include only a small number of subjects. b. sampling error any sample of data or subjects that researchers study may behave differently or have different characteristics from the larger population from which the sample is drawn because the particular collection of a study participants is just one of many potential groups that researchers could have formed from the population of interest. this can lead to sampling error. sampling error is different from91 92 selection bias because it does not involve systematic bias, such as younger individuals disproportionately opting out of a study; it simply occurs because of random variability of subjects.93 small samples are particularly vulnerable to sampling error. for example,94 assume that investigators wish to determine whether cleveland, ohio has a higher cancer rate than other locations in the united states. assume also that they review a sample of one hundred medical records and determine that ten percent of 88. biau et al., supra note 86, at 2282-83; katherine s. button et al., power failure: why small sample size undermines the reliability of neuroscience, 14 nature reviews neuroscience 365, 365 (2013). 89. see eng supra note 87, at 309-12; mohamad amin pourhoseingholi et al., sample size calculation in medical studies, 6 gastroenterology & hepatology from bed to bench 14, 16 (2013). 90. j.h. van der lee et al., efficient ways exist to obtain the optimal sample size in clinical trials in rare diseases, 61 j. clinical epidemiology 324, 324 (2008); see also seunggeun lee et al., optimal unified approach for rare-variant association testing with application to smallsample case-control whole-exome sequencing studies, 91 am. j. hum. genetics 224, 224 (2012). 91. id.; see miguel a. hernán & james m. robins, causal inference 119 (2017) (ebook). 92. douglas g. altman & j. martin bland, uncertainty and sampling error, 349 bmj 1 (2014), http://www.bmj.com/content/bmj/349/bmj.g7064.full.pdf [https://perma.cc/mz2n-9379]. 93. see hernán & robins, supra note 91, at 119. 94. stephen tyrer & bob heyman, sampling in epidemiological research: issues, hazards and pitfalls, 40 bjpsych bulletin 57, 57 (2016). 2018] big data analytics: what can go wrong 241 patients have cancer. they thus would conclude that cleveland has a cancer rate that is double that of the national average which is approximately five percent.95 the problem is that this very small sample may not tell the investigators anything about the true cancer rate in cleveland. it may just happen by chance that an unusually large portion of the patients whose records were reviewed had cancer. thus, it would be inappropriate to generalize the results of this very limited study to the cleveland population at large. c. effect modifiers research outcomes can be skewed by effect modifiers, which are characteristics of patients or of the study that change treatment effects. thus,96 “the magnitude of the association between an exposure and an outcome varies across strata of some other factor.” to illustrate, the degree to which alcohol97 consumption affects blood pressure varies with age, gender, and smoking status, and therefore these three attributes are effect modifiers. effect modification98 merits study for its own sake. moreover, investigators examining the relationship between alcohol and blood pressure will reach mistaken conclusions if they ignore the effect modifiers and do not address them in their analysis. d. causal interactions causal interactions occur when two or more factors interact to produce an effect. the causal factors do not have to operate at the same time, but they all99 contribute to the outcome at issue. for example, in some cases, smoking and100 alcohol consumption interact to cause head and neck cancers. researchers have101 95. see cancer stat facts: cancer of any site, nat’l cancer inst., https://seer.cancer.gov/ statfacts/html/all.html [https://perma.cc/wet3-lanu] (stating that in “2014, there were an estimated 14,738,719 people living with cancer of any site in the united states”). that same year the u.s. population was approximately 317,000,000. robert schlesinger, the 2014 u.s. and world populations, u.s. news & world rep. (dec. 31, 2013, 3:15 pm), https://www.usnews.com/ opinion/blogs/robert-schlesinger/2013/12/31/us-population-2014-317-million-and-71-billion-in-theworld [https://perma.cc/gqy3-z9qe]. 96. jeroen p. jansen & huseyin naci, is network meta-analysis as valid as standard pairwise meta-analysis? it all depends on the distribution of effect modifiers, 11 bmc med. 159, 159 (2013); see tyler j. vanderweele, on the distinction between interaction and effect modification, 20 epidemiology 863, 863 (2009). 97. david c. bellinger, effect modification in epidemiologic studies of low-level neurotoxicant exposures and health outcomes, 22 neurotoxicology & teratology 133, 133 (2000) (footnote omitted). 98. id. 99. kenneth j. rothman & sander greenland, causation and causal inference in epidemiology, 95 am. j. pub. health s144, s145 (2005); tyler j. vanderweele & mirjam j. knol, a tutorial on interaction, 3 epidemiology methods 33, 33 (2014). 100. rothman & greenland, supra note 99, at s145. 101. id. at s146. 242 indiana health law review [vol. 15:227 found that seventy-five percent of head and neck cancer cases can be attributed to smoking and sixty-seven percent to drinking alcohol among those who engage in both behaviors. while these figures may seem puzzling because they add up102 to more than one-hundred percent, they are accurate because smoking and alcohol consumption can interact together to cause cancer. in fact, cancer is generally caused by a multitude of factors, including diet, smoking, occupational exposures (e.g. asbestos) genetic factors, and others. in addition, there can be synergy103 among the different causal factors such that their interaction amplifies the effect of the separate factors. although either smoking or asbestos exposure can cause104 lung cancer, the risk of lung cancer is much higher for individuals who both smoked and breathed asbestos. researchers focusing on one cause of an105 outcome must be aware of potential interactions and multi-causal triggers. v. the prevalence of research m istakes the pitfalls discussed thus far in the article can lead to invalid findings. how often do researchers reach wrong conclusions? according to some experts, more often than not. dr. john ioannidis, who has dedicated his career to studying the credibility of medical research, estimates that “80 percent of non-randomized studies (by far the most common type) turn out to be wrong, as do 25 percent of supposedly gold-standard randomized trials, and as much as 10 percent of the platinum-standard large randomized trials.” this section probes the prevalence106 of research mistakes. a. association v. causation if researchers succumb to some of the pitfalls described in the article, they may mistake mere association for actual causation. they may identify107 associations between certain exposures and particular outcomes but wrongly conclude that there is an actual causal relationship between them. to illustrate,108 102. id.; see also rothman et al., supra note 56, at 71. 103. rothman & greenland, supra note 99, at s146; vanderweele & knol, supra note 99, at 33. 104. vanderweele & knol, supra note 99, at 35. 105. id. 106. freedman, supra note 15; see also john p. a. ioannidis, why most published research findings are false, 2 plos med. 0696 (2005), http://journals.plos.org/plosmedicine/article?id= 10.1371/journal.pmed.0020124 [https://perma.cc/4gdl-e6fp]. 107. see, e.g., austin bradford hill, the environment and disease: association or causation?, 58 proc. royal soc’y med. 295, 295–300 (1965); arvid sjölander, the language of potential outcomes, in causality: statistical perspectives and applications 6, 9 (carlo berzuini et al. eds., 2012). 108. see stephen choi et al., the power of proxy advisors: myth or reality? 59 emory l.j. 869, 879–85 (2010) (discussing the difference between correlation and causation); csaba p. kovesdy & kamyar kalantar-zadeh, observational studies vs. randomized controlled trials: avenues to causal inference in nephrology, 19 advanced chronic kidney disease 11, 11-12 2018] big data analytics: what can go wrong 243 data analysis may suggest that drinking coffee increases an individual’s risk of lung cancer. the association would likely disappear, however, when analysts109 adjust for the fact that, generally, coffee drinkers are more likely to smoke cigarettes than non-coffee consumers, and it is cigarette smoking that, in truth,110 increases lung cancer risk. researchers who confuse the association between111 coffee and lung cancer for a causal relationship would stumble because of confounding bias. scientists have found that a genetic variant influences both112 caffeine consumption and smoking, which in turn increases the risk of lung cancer, and thus the genetic factor is a confounder. moreover, smoking itself113 may cause individuals to drink more coffee because nicotine increases the metabolism of caffeine, so that smokers lose the stimulating effects of caffeine more quickly. smoking is thus a confounder that causes both increased coffee114 drinking and lung cancer. without awareness of the genetic and smoking confounders, researchers could reach erroneous conclusions about the cause of lung cancer. as a second example, selection bias can cause analysts to mistake association for causation. suppose researchers are interested in the question of whether folic acid, taken during pregnancy, can prevent fetal heart defects. assume too that the investigators include only babies that are born live and exclude from the study fetuses that are miscarried. researchers might conclude that folic acid is linked to a reduction in the number of fetal heart defects. however, no causal link can be assumed because fetuses that were miscarried were not studied. some of115 these fetuses, in fact, may not have survived because of heart defects. researchers who posit that folic acid reduces fetal heart defects based on these results would have failed to establish an actual causal relationship between the treatment and outcome. b. inability to replicate study findings research errors can make it impossible for researchers to replicate studies and confirm results. although it may be far more exciting to make new discoveries,116 (2012). 109. bellinger, supra note 97, at 133. 110. jorien l. treur et al., associations between smoking and caffeine consumption in two european cohorts, 111 addiction 1059, 1059 (2016) (stating that “[t]here appears to be a positive association between smoking and caffeine consumption in the netherlands and the united kingdom”). 111. id. 112. see supra part iii.b. 113. treur et al. supra note 110, at 1066; akshat rathi, there’s a reason why smokers drink more coffee, quartz (mar. 7, 2017), https://qz.com/926328/scientists-can-explain-why-smokersdrink-more-coffee-genetics-metabolism-and-blunted-taste-buds/ [https://perma.cc/9dkm-8cfu]. 114. treur et al. supra note 110, at 1066; rathi, supra note 113. 115. hernán & robins, supra note 91, at 95. 116. michael price, to replicate or not to replicate?, sci. (dec. 2, 2011, 10:00 am), 244 indiana health law review [vol. 15:227 the work of reproducing prior study results is essential to scientific integrity and the validity of research claims. 117 replicability is a very significant problem for both clinical and observational research. to replicate a clinical trial, a new group of investigators conducts the experiment again, and in the case of a record-based study, new analysts examine a different data set and try to obtain the same findings. but if the initial study118 outcome is erroneous because of data quality, biases, and/or the other shortcomings discussed above, it will not be reproducible. on the other hand, if replication studies are themselves tainted by any of these problems, they will fail even if the original results are legitimate. in 2005, dr. john ioannidis published a study in jama, a top medical journal, focusing on forty-nine of the most highly regarded research findings published during the prior thirteen years. of these, forty-five studies claimed to have119 discovered effective interventions, and thirty-four of these findings were retested in order to validate results. astonishingly, upon retesting, fourteen of the claims (forty-one percent) were shown to be incorrect or exaggerated.120 in a highly publicized 2015 article, the journal science featured “a largescale, collaborative effort to obtain an initial estimate of the reproducibility of psychological science.” investigators attempted to reproduce the outcomes of121 one-hundred recent peer-reviewed psychology experiments, but were successful in only thirty-nine cases. 122 commentators bemoan the “replication crisis,” and journalists have written articles with headlines such as “is science broken?” others are less pessimistic123 http://www.sciencemag.org/careers/2011/12/replicate-or-not-replicate [https://perma.cc/l5wtpsgl]; timothy m. errington et al., an open investigation of the reproducibility of cancer biology research, elife , (dec. 10, 2014), https://www.ncbi.nlm.nih.gov/ pmc/articles/pmc4270077/ [https://perma.cc/y2ds-jvdw] (asserting that “careers are made by producing exciting new results at the frontiers of knowledge, not by verifying prior discoveries”). 117. open science collaboration, estimating the reproducibility of psychological science, 349 sci. 943, 943 (2015); matthew c. makel & jonathan a. plucker, facts are more important than novelty: replication in the education sciences, 43 educ. researcher 304, 304 (2014); jens b. asendorpf et al., recommendations for increasing replicability in psychology, 27 eur. j. personality 108, 108 (2013) (“replicability of findings is at the heart of any empirical science.”). 118. makel & plucker, supra note 113, at 304 (emphasizing “the importance of third-party, direct replications in helping education research improve its ability to shape education policy and practice); arturo casadevall & ferric c. fang, reproducible science, 78 infection & immunity 4972, 4972-75 (2010). 119. john p. a. ioannidis, contradicted and initially stronger effects in highly cited clinical research, 294 jama 218, 218 (2005) (“the size of the sample studied is a major determinant of the risk of reporting false-negative findings”). 120. id. 121. open science collaboration, supra note 117, at 943. 122. id. 123. daniel engber, is science broken or is it self correcting?, slate (aug. 21, 2017, 6:00 am ) , h t t p : / / www.s l a t e . co m/ar t i c les /h ea l th _ an d _ sc i ence / sc i en ce /20 1 7 / 0 8 / 2018] big data analytics: what can go wrong 245 about replication failures and state that “[w]e should just be looking at an accumulating evidence paradigm, where we’re getting closer and closer to truth.” still others argue that replications might fail because they themselves124 are flawed, that is, the later studies are not conducted under the same conditions by people with the same level of expertise as the original investigators. 125 nevertheless, repeated replication failures have distressed the scientific community and all who care about the medical research endeavor. many agree that “[r]eplication is central to the progress of science: if others cannot reproduce the evidence backing a scientific claim, then the claim loses status as scientific knowledge.” the internet can enable exchange of data protocols, and software,126 and such data sharing should greatly facilitate replication efforts. researchers should take advantage of these opportunities and also do their utmost to ensure that their studies are free of errors and biases so that they can be duplicated by skilled analysts. vi. conclusion this article has analyzed numerous challenges that researchers face in analyzing big data (and other health information). these include data quality deficiencies; selection, confounding, measurement, and confirmation biases; inadequate sample sizes; sampling errors; effect modifiers; and causal interactions. all of these can cause researchers to mistake mere associations for causal relationships and to reach conclusions that are invalid and cannot be replicated in subsequent studies. erroneous research findings can mislead legislators, regulators, and lawyers, who use them for purposes of policy-making or litigation. formulating solutions for these research obstacles is beyond the scope of this paper, and i have done so in prior work. suffice it to say that well-developed127 science_is_not_self_correcting_science_is_broken.html [https://perma.cc/5hy7-jynn]; joel achenbach, many scientific studies can’t be replicated. that’s a problem, wash. post (aug. 27, 2015), https://www. washingtonpost.com/news/speaking-of-science/wp/2015/08/27/trouble-inscience-massive-effort-to-reproduce-100-experimental-results-succeeds-only-36times/?utm_term=.ab0793214a51 [https://perma.cc/gtt9-6ppl]. 124. christie aschwanden, failure is moving science forward: the replication crisis is a sign that science is working, fivethirtyeight (mar. 24, 2016), https://fivethirtyeight.com/ features/failure-is-moving-science-forward/ [https://perma.cc/zxs6-9pyt]. 125. mina bissell, reproducibility: the risks of the replication drive, nature (nov. 20, 2013), http://www.nature.com/news/reproducibility-the-risks-of-the-replication-drive-1.14184 [https://perma.cc/w5jz-fhy6] (arguing that “[p]eople trying to repeat others' research often do not have the time, funding or resources to gain the same expertise with the experimental protocol as the original authors, who were perhaps operating under a multi-year federal grant and aiming for a high-profile publication.”); errington et al., supra note 116 (discussing whether failure to replicate always means “that the original result was a false positive”). 126. errington et al., supra note 116. 127. see hoffman & podgurski, supra note 1, at 527-38; sharona hoffman, medical big 246 indiana health law review [vol. 15:227 techniques can allow researchers to adjust for biases and identify true causal factors. however, the pitfalls of big data analysis are numerous, and anyone128 conducting, reviewing, or relying upon it must be aware of their existence. we all must know what questions to ask and what potential flaws to scrutinize, whether we be scientists, attorneys, policy-makers, or members of the interested public.129 data quality and analysis concerns, in electronic health records and medical big data: law and policy 160-67 (cambridge u. press 2016). 128. hammer et al., supra note 68, at 667; kovesdy & kalantar-zadeh, supra note 108, at 15. 129. david faraoni & simon thomas schaefer, randomized controlled trials vs. observational studies: why not just live together?, bmc anesthesiology (oct. 21, 2016), ht tps: / /bmcanesthesiol .biomedcentral .com/articles/10.1186/s12871-016-0265-3 [https://perma.cc/5tm5-9cfj] (urging that “it remains our accountability to scrutinize methods, controls and conclusions drawn in all the papers we read”). ihlr vol 14 iss. 2.pdf http://doi.org/10.18060/3911.0034 https://doi.org/10.7326/0003-4819-149-1-200807010-00010 https://doi.org/10.1016/j.jchf.2014.07.016 https://doi.org/10.4103/2229-5151.84800 https://doi.org/10.1089/jpm.2005.8.789 https://doi.org/10.4037/ajcc2012394 http://doi.org/10.1111/jgs.12736 https://doi.org/10.1136/jme.11.4.184 https://doi.org/10.1016/0890-4065(91)90011-g https://doi.org/10.1111/j.1468-0009.2010.00596.x https://doi.org/10.1093/geront/45.2.262 https://doi.org/10.1111/j.1532-5415.2012.04212.x http://doi.org/10.1056/nejmms1611497 https://doi.org/10.1300/j031v09n04_03 indiana health law review volume 11 2014 issue 2 table of contents articles tracy d. gunter can we trust consumers with their brains? popular cognitive neuroscience, brain images, self-help and the consumer............... 483 leonard m. fleck just caring: do the indolent, the inebriated and the irresponsible deserve equal access to needed health care? . . . . . . . . . . . . . . . . . 553 jessica berg the e-health revolution and the necessary evolution of informed consent................ ...................... ...... 589 christopher t. robertson and david v. yokum the burden of deciding for yourself the disutility caused by out-ofpocket healthcare spending ........................ ...... 609 lindsay f. wiley access to health care as an incentive for healthy behavior? an assessment of the affordable care act's personal responsibility for wellness reforms ...................................... 635 notes samuel j. dayton rethinking health app regulation: the case for centralized fda voluntary certification of unregulated non-device mobile health apps ............................................... 713 james b. banister new technology and increased globalization: addressing difficulties presented in the current fda inspection process .............. 751 charlotte fillenwarth beyond the emergency room doors: rejecting patient admittance as satisfaction of hospital obligations under emtala ....... ..... 791 thomas f. martin ii the stark inaccessibility of medical care in rural indiana: judicial and legislative solutions. .............................. ..... 831 indiana health law review editor-in-chief janice pascuzzi executive managing editor samuel dayton executive editor thomas martin executive busin'ess editor jessica dugdale note development editors paul ho charity mansfield james nussbaum executive notes editor nicole sharp executive articles editor james banister executive production editor romy elswerky articles editors christopher anderson charlotte fillenwarth laura sahm note candidates zahra ayoubi samantha chapman whitney dather brandie ecker matthew folz michael hooker james jared jake kolisek matthew lorenzo kristi mcmains cathleen nine-altevogt tyler olson andrew podgorny allison potenza julie riche colby schade van westrum jason sprinkle . julian stephenson robert whitham justin wiser faculty advisors nicolas p. terry (chair) david orentlicher (chair) eleanor d. kinney (adviser emerita) robert a. katz emily morris miriam murphy (research liaison) ben keele (research liaison) volume 11 2013-20142013-2014 indiana health law review (issn 1549-3199) content. the indiana health law review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. the scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. the indiana health law review will be published twice during the 2013-14 academic year. disclaimer. the ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the indiana health law review or indiana university robert h. mckinney school of law. subscriptions. the current subscription rate is $20.00 for two issues (domestic mailing). unless the business office receives notice to the contrary, all subscriptions 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review symposium articles: neuroscience and law: injury, capacity and illness ideology meets reality: what works and what doesn’t in patient exposure to health care costs victor laurion and christopher robertson * summary u.s. policymakers, scholars, and advocates have long displayed an ideological commitment to exposing insured patients to substantial out-of-pocket expenses. these commitments derive from both overt political ideologies, which favor individual responsibility and oppose redistribution of wealth and risks, as well as more-subtle ideological commitments of academic economists, which link observed patterns of consumption to value-claims about welfare. in this symposium contribution, we document those ideological commitments and juxtapose them with a review of the scientific evidence about the actual effects of patient cost-sharing. we find, as economic theory predicts, that patients exposed to healthcare costs consume less healthcare. however, a fair review of the evidence—including the effects on health outcomes, access to care, and financial insecurity—makes it very hard to conclude that substantial and untailored cost-sharing exposure—as we have seen in actual application—is good social policy. we suggest directions for future study and reform. i. an introduction to cost-sharing and underinsurance one key piece of the affordable care act (aca) was its focus on getting more people covered by health insurance. indeed, it succeeded in insuring more than 20 million additional people. but measuring the aca by increases in the numbers of insured overlooks a problem that affects even more americans: incomplete insurance or underinsurance. even for those who enjoy coverage, health insurance in the united states is incomplete, leaving patients exposed to substantial out-of-pocket costs in the forms of deductibles, copays, coinsurance, and reference prices. as an introduction, we briefly review each of these mechanisms. deductible: a deductible is an aggregate, annual sum that must be spent by the patient before the insurance policy “kicks in” or pays its first dollar of benefit. the average annual deductible in 2016 was $1,478, up from $1,318 in the prior year. naturally there are exceptions. depending on the policy, not all of a1 patient's out-of-pocket spending on healthcare may count towards the deductible. also, under the aca, some healthcare, such as preventive services, are covered at the first dollar and not subject to the deductible. 2 * the authors thank john nyman, david orentlicher, and anne royalty for comments on prior drafts. gautam gowarisankaran and keith joiner provided helpful insights as well. our thanks do not imply endorsement of this paper. 1. employer health benefits 2016 annual survey, henry j. kaiser fam. found. & health res. & educ. tr., 4 (sep. 14, 2016), http://files.kff.org/attachment/report-employerhealth-benefits-2016-annual-survey [https://perma.cc/ejq3-r6y7]. 2. 42 u.s.c. § 300gg-13(a)(4) (2010). http://doi.org/10.18060/3911.0043 44 indiana health law review [vol. 15:43 deductibles cause insurance contract payouts to be non-linear, in that a patient’s exposure to costs will sharply change (decrease) after the annual deductible has been met. anecdotally, physicians come to expect a flurry of appointment-making activity near the end of the calendar year as patients who have met their annual deductible seek care in the more favorable cost-sharing structure. patients who are chronically sick almost always exceed their deductible in a given year. for these individuals who are predictably ill, the deductible is more like a second insurance premium they will inevitably pay, which rationally should have no effect on consumption behavior. coinsurance: the coinsurance rate is the percentage of medical costs for which a patient is responsible. this rate generally applies to expenses incurred after the deductible has been met, but before an annual cap on cost-sharing is met. thus, the coinsurance rate before meeting the deductible is effectively 100%, and becomes generally much smaller—10% to 25% thereafter. the average innetwork coinsurance rates in 2016 were 18% for primary care and 19% for specialty care. 3 the coinsurance amount is commonly calculated from the reimbursement amount negotiated between health care providers and insurers, and is often billed to the patient after care is chosen and provided, making it less salient to a patient’s in-the-moment medical decisions. co-payment: a co-payment is the amount a patient must pay out-of-pocket at the time of service. because these payments are set prospectively, they do not reflect the actual cost of services delivered during that medical encounter. average in-network co-payments in 2016 were $24 for primary care office visits and $38 for specialty care office visits. co-payments serve as the chief cost4 sharing mechanism for prescription pharmaceuticals. out-of-pocket maximum: the out-of-pocket maximum limits the aggregate cost-sharing exposure faced by a policyholder over the year-long term of the policy. the aca sets a cap on how high these out of pocket maximums may be. in 2016 that cap was $13,700 for families. in application, however, most caps are much lower. only 18% of workers had out-of-pocket limits over $6,000, and about as many (14%) had limits less than $2,000.5 reference pricing: reference pricing is a dollar-value of reimbursement set by the insurer for a specific medical service or good. one common application is for pharmaceuticals, where a payor will fully reimburse a generic version, but allows consumers to pay extra for a branded version of a drug if they prefer. in6 other domains, the reference price is generally derived by the insurer surveying prices in a locality and setting a reference price near the midpoint of the range. for example, an insurer may set a price for an orthoscopic knee surgery at 3. employer health benefits 2016 annual survey, supra note 1, at 4. 4. id. at 121. 5. id. at 5. 6. see generally joy li-yueh lee, et al., a systematic review of reference pricing: implications for us prescription drug spending, 18 am. j. managed care e429 (2012). 2018] ideology meets reality 45 $18,000. if a covered patient opts for a provider that charges more than the7 reference price, that patient must pay the additional costs incurred above the reference price. if a covered patient selects a provider that delivers care at or below the reference price, the patient will receive coverage with minimal cost sharing. the reference price makes patients completely sensitive to the marginal prices charged above the reference point, and thus may cause competition by providers, driving down prices to capture market share. deductibles, coinsurance, copayments, and reference prices are the several different ways in which health insurance plans leave patients exposed to some of the costs of their healthcare. in this sense, people are not merely insured or uninsured. even among the insured, people are more or less insured, depending on how much risk remains uncovered. putting aside the risk frame, these payments can also be barriers to care: an individual who holds a policy with costsharing provisions will eventually be compelled to make additional payments to access his or her insurance benefit. as evidenced below, this payment structure predictably reduces the use of insurance and, by extension, the use of healthcare. but it is less clear whether such an exposure is good social policy. this paper proceeds as follows. in part ii, we review ideological commitments among economists and politicians, in favor of incomplete insurance. in part iii, we briefly offer a comparative perspective, showing how other countries, without these ideological commitments, have taken other paths. in part iv, we review the evidence about the effects of cost-sharing policies on consumption and, where available, on health outcomes. we then offer conclusions that suggest future directions for research and policy. ii. ideology in this part, we document five decades of ideological commitments of academic economists and politicians, which have together caused u.s. health policy to embrace cost-sharing so systematically. in subsequent parts, we evaluate these ideological commitments in the light of empirical evidence about how health insurance and cost sharing actually work in practice. a. academic economic ideology in a seminal 1963 paper, nobel prize laureate kenneth arrow identified health insurance as a peculiarly-important need, one so imperative that it should (and would) be provided by public means in the event a private market failed to form. his advocacy for health insurance was driven by the significance of the8 risk involved, the unpredictability of a patient’s need for healthcare, and the importance of healthcare services to wellbeing—hallmark traits of a landscape in 7. see james c. robinson & timothy t. brown, increases in consumer cost sharing redirect patient volumes and reduce hospital prices for orthopedic surgery, 32 health aff. 1392 (2013) (utilizing a natural experiment to assess the impact of reference prices). 8. kenneth j. arrow, uncertainty and the welfare economics of medical care, 53 am. econ. rev. 941 (1963). https://doi.org/10.1377/hlthaff.2013.0188 46 indiana health law review [vol. 15:43 need of insurance. in any given year, most people will have little or no healthcare costs, but others will have terrible years, where they may incur many thousands of dollars in medical bills, potentially devastating them financially. it follows that rational consumers would spend a comparatively small percentage of their income every year on insurance to avoid the risk of being wiped out financially if they are unlucky enough to be among the very few who are very sick. this economic point is known as the diminishing marginal utility of money: as income increases (in good years), each additional dollar becomes less important to retain. those dollars have more value if reallocated to bad years, of high medical expenses. contrast the nominal cost of protection with the risk of financial devastation and we start to understand why the payment of health insurance premiums is a worthy expenditure for those with something to lose. nonetheless, arrow foreshadowed a core problem with health insurance in the fact that “the cost of medical care is not completely determined by the illness suffered by the individual but depends on the choice of a doctor and his willingness to use medical services.” here arrow hits upon a complexity that is9 particular to health insurance—the financial beneficiaries of health insurance are in a position to trigger a benefit on their own, in the absence of an external, verifiable event. in this sense, health-related risks are different from other exogenous risks for which we might rationally also buy insurance, such as a house burning down from a lightning strike. in health care, patients and doctors can largely choose what to consume and when to consume it, but the insurer pays. the derived concern—that such an arrangement would lead to inefficient overconsumption on the part of the beneficiaries—came to be known as “moral hazard.” 10 mark pauly developed the problem further in terms of “elastic” demand—that is, how the quantity of healthcare that people demand changes with the price faced by those people. as insurance drives down the price borne by the11 consumer (to zero for full insurance), insurance will also drive up the quantity demanded. pauly advanced the economic doctrine by identifying a collective action problem. “each individual may well recognize that ‘excess’ use of medical care makes the premium he must pay rise. no individual will be motivated to restrain his own use, however, since the incremental benefit to him for excess use is great, while the additional cost of his use is largely spread over other insurance holders, and so he bears only a tiny fraction of the cost of his use.” pauly12 warned that, in aggregate, the loss from excess consumption may eclipse the 9. id. at 961. 10. see generally tom baker, on the genealogy of moral hazard, 75 tex. l. rev. 237 (1996) (describing the concept’s origination with nineteenth-century insurers, and its popularity in the 1900s to “signif[y] the perverse consequences of well-intentioned efforts to share the burdens of life, and it also helps deny that refusing to share those burdens is mean-spirited or selfinterested”). 11. mark v. pauly, the economics of moral hazard: comment, 58 am. econ. rev. 3 (1968). 12. id. at 534. 2018] ideology meets reality 47 utility gain from protecting against uncertain expenses such that “the net change in utility from a compulsory purchase of this ‘insurance’ could well be negative”. that is, if not carefully crafted and deployed, health insurance could13 cause more harm than good to the society it was intended to support. even in these early days of health economics, ideological momentum was gaining: one ought to be skeptical of fulsome insurance coverage. building on the work of arrow and pauly, richard zeckhauser posited that "no practicable market structure will simultaneously produce optimal riskspreading and appropriate incentives for individual action.” insurance will14 inevitably encourage a “perverse incentive toward overexpenditure” as it is confounded by the presence of two elements: (1) “the insureds have substantial influence on the amount that is spent on their own behalf in any particular medical circumstance”; and (2) “the level of reimbursement by the insurance plan is a positively associated function of the expenses incurred by its insureds.” in short, the more that insurance provides risk-protection the more it also induces wasteful spending. in addressing this concern, zeckhauser set out to define parameters for an economic compromise that included “some risk-spreading and some incentive” under varying health conditions. this is the theory of cost-15 sharing, the imperative to make insurance incomplete, to give patients some skinin-the-game. in response to growing national expenditures on healthcare, martin feldstein offered a 1973 paper to demonstrate that “american families are in general overinsured against health expenses.” by this, feldstein meant that the families16 could sustainably bear greater risks themselves, rather than redistributing them to the insurance pool. he contended that the insured society as a whole could increase welfare by increasing the coinsurance rate, and thereby exposing the individual insureds to a greater proportion of the cost. feldstein succinctly17 highlighted an important feedback loop within health insurance: “there is mutually reinforcing behavior: more insurance increases the price of care, and a higher price of care increases the demand for insurance.” as prices rise, it18 becomes all the more foolish to go without insurance, because that would mean exposing oneself to greater risk of huge costs (and exposing oneself to the risk of not getting care at all). as economic evidence grew, feldman and dowd revisited the notion of a welfare loss generated by excess health insurance. in their 1991 paper, the authors comment that “consumers are considerably more risk-averse than feldstein assumed,” yet even when the gain from risk-bearing is considered, “this gain is 13. id. 14. richard zeckhauser, medical insurance: a case study of the tradeoff between risk spreading and appropriate incentives, 2 j. econ. theory 10, 10 (1970). 15. id. 16. martin s. feldstein, the welfare loss of excess health insurance, 81 j. pol. econ. 2, 251 (1973). 17. id. at 251. 18. id. at 276-77. https://doi.org/10.1016/0022-0531(70)90010-4 https://doi.org/10.1086/260027 48 indiana health law review [vol. 15:43 not large enough to outweigh the loss due to excess consumption of medical care.” the feldman and dowd thesis holds that health insurance may actually19 make people worse off overall, because it creates more wasteful spending than the value it delivers by protecting them from risk. on this view, society would want to reduce fulsome health insurance coverage, increasing cost-sharing wherever possible to maintain a working price signal -which is precisely what health insurers have been doing for the last several decades. looking back, we see a generation of economists trained on this doctrine that health insurance creates moral hazard (defined as the rational choice to consume more when the observed cost is artificially low) and that moral hazard is simply wasteful health spending. but how do we know that the extra spending caused by insurance results in welfare loss? economists are remarkably agnostic about value—they have no substantive doctrine that can specify whether a given health intervention (e.g., joint replacement) is worth a given price (e.g., $45,000), and thus are unable to say whether or not such consumption is worthwhile. their ideology does, however, depend on a heuristic for making such evaluations. if we simply adopt, as an archimedian point, the behavior of an uninsured patient (i.e., one using his own wallet to fund all healthcare consumption) and assume that he considers the potential benefits of a treatment and weighs them against the price charged, then his behavior will reveal value. if such an uninsured patient20 declines a given unit of healthcare at a given price, then we can infer that its benefits were outweighed by its price. we can thus infer that, for such a situated patient, that particular sort of healthcare would have been a waste. if a similarly situated insured person, on the other hand, buys this same unit of healthcare, it follows that the consumption was wasteful. the elimination of the price signal is what caused the marginal additional consumption, which apparently was not worth its price. the analytic model is a powerful way to identify healthcare waste, as far as it goes. notably, however, this theory depends on an idealized market transaction—the uninsured individual purchasing healthcare using his or her own wealth—as the normative baseline. in the early 2000s, john a. nyman suggested an alternative to the traditional theory of moral hazard and welfare loss. where economic doctrine had for21 decades assumed that moral hazard was simple waste—entirely inefficient and welfare-degrading, nyman argued that insurance enhances the purchasing power of the insured, specifically the sick insured, by redistributing from the healthy to the ill. yes, insured people buy more healthcare than uninsured people, but some 19. roger feldman & bryan dowd, a new estimate of the welfare loss of excess health insurance, 81 am. econ. rev. 297, 300 (1991). 20. see, e.g., mark v. pauly, medicare drug coverage and moral hazard, 231 health aff. 113 (2004) (making explicit that standard economic theory depends on the uninsured person as the counterfactual situation for making inferences about the value of healthcare interventions, and identifying marginal consumptions by insured persons as “waste”). 21. see generally john a. nyman, the theory of demand for health insurance (2003). https://doi.org/10.1377/hlthaff.23.1.113 2018] ideology meets reality 49 of the uninsured people declined to purchase high-value healthcare simply because they lacked the cash or credit to do so. one cannot infer that spending on healthcare is wasteful just because the uninsured do not consume it. on nyman’s view, the driving motivation (and benefit) for buying health insurance is not just to offset risk, but rather to allow the insured to afford costly medical care that would be otherwise unaffordable. accordingly, a transfer of wealth for such purposes (from the collective insurance pool to the sick individual) may be in fact beneficial and efficient, even if it stimulates spending beyond that which uninsured individuals spend. indeed, that stimulation of consumption is not an unwelcome side effect of insurance. that is a primary purpose of insurance in the first place. to be sure, nyman’s theory does not repudiate moral hazard altogether, nor does it repudiate cost sharing as a policy mechanism. it remains true that insurance may cause some wasteful consumption by disrupting the price signal. however, nyman’s theory makes it much more difficult to identify waste; a simple economic comparison of uninsured behavior to insured behavior does not suffice. “not all moral hazard is welfare decreasing. some moral hazard purchases are efficient and some are inefficient, and the challenge for policy is to distinguish one from the other in order to apply cost sharing only to the inefficient moral hazard.”22 nyman’s work has failed to change the paradigm of health economics.23 young economists are still trained on health economics textbooks, which continue to equate moral hazard with welfare loss and “emphasize” that “only risk-averse individuals demand insurance.” in contrast, on nyman’s plausible24 view, a risk-neutral person with limited wealth may nonetheless rationally buy a health plan that creates access to care that he otherwise couldn’t afford. in a recent review article, kelman and woodward conclude that nyman’s “major challenge” to economic thinking about moral hazard has been largely ignored by economists themselves. 25 health economics may be slow to embrace nyman’s theory because the 22. id. at 165. 23. see thomas kuhn, the structure of scientific revolutions (1962) (describing how scientific domains deal with anomalies, and only rarely change fundamental paradigms). 24. frank a. sloan & chee-ruey hsieh, health econ. 143 (2012); see also id at 512 (describing nyman’s theory in passing, but not in the chapter on demand for healthcare and moral hazard). for a standard description in the field, see frank d. gianfrancesco, the choice among medical insurance plans, 78 am. econ. rev. 277, 278 (1988) (“the welfare loss from moral hazard has two components. the first is due to the excess consumption of medical care caused by the price effect inherent in [conventional insurance]. the second component of welfare loss is due to the cost sharing required to moderate this effect. while cost sharing reduces excess consumption, it also reduces the risk-absorbing benefits of insurance.”). 25. sander kelman & albert woodward, john nyman and the economics of health care moral hazard, 2013 isrn econ. 1 (2013). see also amy finkelstein et al., moral hazard in health insurance (2014) (providing an edited retrospective on arrow’s article and the debate the follows, but completely overlooking nyman’s intervention). https://doi.org/10.1155/2013/603973 50 indiana health law review [vol. 15:43 theory makes it much more difficult for economists to speak to policy-relevant questions. simplistic observations that insurance increases consumption of health care tell us nothing about whether that is a good or a bad thing. instead, to make smart policy we need experts (e.g., physicians) and richer datasets including real health outcomes to identify good and bad healthcare on its own merits. economists are less likely to adopt a theory that effectively undermines their own central role as policy advisors. making matters more complicated, recent work by katherine baicker and colleagues propose a model for mis-utilization to layer atop moral hazard. baicker's model includes “behavioral hazard,” which can cause patients to fail to consume worthwhile healthcare. behavioral hazard accounts for patient biases26 rooted in overweighting salient symptoms (e.g., pain being more salient than hypertension), overweighting the immediate costs of care (e.g., co-payments and short-term effort investments), and making choices based on false beliefs (e.g., faulty mental models, incomplete information, or inattention to the available evidence). in short, behavioral hazard is why patients make choices that appear to go against their own best interests. the authors propose that while co-payments have been the principal moderator of moral hazard in health insurance, nudges—or non-financial instruments such as reminders or framing—can help to mitigate behavioral hazard driving market inefficiency. 27 b. political ideologies the profession of economics has not been alone in its ideological commitments to cost-sharing as a means of reducing waste. for more than 5028 years, at the highest political levels, among both liberal and conservative u.s. presidents, there has been a remarkable ideological consensus about the risk of moral hazard and the importance of cost-sharing in health insurance. in a 1966 meeting with hospital leaders to prepare for the launching of medicare, democratic president lyndon johnson worried that the newly insured would “abuse” their insurance. “there will be some who will demand unnecessary treatment.” president johnson appealed to those at the “grassroots”29 level, closest to the delivery of care, to “stand firm against these abuses.” in a30 statement on the inauguration of medicare, president johnson reiterated that 26. katherine baicker et al., behavioral hazard in health insurance, 131 q.j. econ. 1623 (2015). 27. see generally nudging health: health law and behavioral economics (i. glen cohen et al. eds., johns hopkins univ. press 2016). 28. see generally michael drummond, the use of economic evidence by healthcare decision makers, 2 eur. j. health econ. 2 (2001) (discussing generally the use of economic theory worldwide by healthcare policy decision makers). 29. ctrs. for medicare & medicaid services, cms history project president’s spe e c he s 35, ht tps: / /www.cms.gov/about-cms/agency-information/history/ downloads/cmspresidentsspeeches.pdf [https://perma.cc/cvu6-zbgf]. 30. id. at 36. https://doi.org/10.1093/qje/qjv029 https://doi.org/10.1007/pl00012215 2018] ideology meets reality 51 “medicare will succeed if older patients cooperate in scheduling treatment and do not demand unnecessary hospital and medical services,” closing his thought with: “i have confidence in the commonsense of our older americans.” president31 johnson acknowledged the problem of moral hazard, but thought that folksy common sense and moral exhortation might solve it. nonetheless, medicare also included several cost-sharing features. 32 republican president nixon sought to continue cost-sharing practices in his national health insurance partnership act of 1972. president nixon proposed33 a package that “would include certain deductibles and coinsurance features, which would help keep costs down by encouraging the use of more efficient health care procedures.” 34 republican president ford echoed these cost-sharing sentiments in a 1976 message to the congress regarding medicare, saying: “[a]dditional cost sharing provisions are also needed to encourage economical use of the hospital and medical services included under medicare.” he went on to recommend a 10%35 coinsurance rate for hospital and nursing home charges, and an increase in the existing annual deductible from $60 to $77. 36 democrat president carter, in outlining his 1979 national health plan to congress, emphasized protecting all americans from “catastrophic expenses,” stating that “no american should live in fear that a serious illness or accident will mean bankruptcy or a lifetime of debt.” to this end, he proposed widespread37 caps on out-of-pocket spending with targeted cost-sharing curtailments to only those most vulnerable populations. “today, the elderly also face heavy financial38 burdens because physicians increasingly charge more than the medicare fee,” president carter continued, “under the national health plan, physicians would be prohibited from charging elderly patients more than the allowable fee.”39 president carter also makes special note of cost sharing as it pertains to maternal and infant health, “[e]mployers will provide employees and their families with coverage for prenatal care, delivery, and infant care to age one, without any cost sharing.” his approach to a variable application of cost sharing is a nod to his40 understanding of its significance in the lives of the poorer insured. his approach is also, arguably, a harbinger of the value-based insurance design of our present era in that it selectively applies the tools of cost sharing. republican president reagan, in a 1983 address to congress on health 31. id. at 42. 32. nancy de lew, medicare: 35 years of service, 22 medicare & medicaid res. rev. 75 (2001). 33. ctrs. for medicare & medicaid services, supra note 29, at 73. 34. id. at 60. 35. id. at 82. 36. id. 37. id. at 97. 38. id. at 98. 39. id. 40. id. at 99. 52 indiana health law review [vol. 15:43 reforms, remarked that under the existing coinsurance format there is “no financial incentive for the [medicare] beneficiary to leave a hospital as soon as it is medically advisable to do so.” he proposed changing that policy to include41 more cost sharing in the first 60 days of hospitalization to “encourage beneficiary cost consciousness and the efficient use of health resources.” in addition to42 coinsurance, president reagan also saw increasing the medicare part b deductible as a way to curb spending: [c]urrent law does not provide for future increases in the deductible. as a result, the initial beneficiary liability for medical services will decrease in real terms over time and these costs will be shifted to the federal government. furthermore, the value of the deductible as a deterrent to unnecessary utilization will again diminish.43 he also touched upon the importance of copayments in medicare, channeling academic economists: [f]irst-dollar insurance coverage, such as that which medicaid provides, leaves the consumer with virtually no financial incentive to question the need for services. services that are totally free are likely to be over utilized. if patients share in some of the costs, they and their physicians will reduce unnecessary or marginal utilization.44 from here, democrats picked up the mantle. president clinton made ‘responsibility’ one of the six principles of his 1993 health security act: too many of us have not taken responsibility for our own health care and for our own relations to the health care system. many of us who have had fully paid health care plans have used the system whether we needed it or not without thinking what the costs were.45 president clinton went on to suggest that cost sharing is an effective way to engender responsibility, perhaps as an intrinsic value. there can’t be any something for nothing, and we have to demonstrate that to people. this is not a free system. even small contributions, as small as the $10 co-payment when you visit a doctor, illustrates that this is something of value. there is a cost to it. it is not free.46 in his advocacy for the expansion of health savings accounts, republican president george w. bush emphasized the importance of healthcare consumers responding to financial incentives. 41. id. at 120. 42. id. 43. id. at 124. 44. id. at 125. 45. id. at 153. 46. id. 2018] ideology meets reality 53 under the system that currently exists, consumers really don't know how far their health care dollars are going. you pay the premium and then you just show up and collect the benefits. you have no idea what you're spending money on. they pay a flat rate for insurance, but they really don't know the true costs of medical services they receive . . . when consumers don't have the incentive to get better prices, costs go up.47 in his september 2009 speech to congress introducing his healthcare bill, democrat president barack obama’s proposals for cost sharing had the opposite valence. “we will place a limit on how much you can be charged for out-ofpocket expenses, because in the united states of america, no one should go broke because they get sick.” he also made specific mention of prescription48 drug copayments for medicare beneficiaries. “we can use some of the savings to fill the gap in coverage that forces too many seniors to pay thousands of dollars a year out of their own pockets for prescription drugs.” in an address to the49 nation on march 3, 2010, president obama further appealed to the cost-sensitive healthcare consumer by explaining that if his legislation were to pass, “no longer would they be able to force you to pay unlimited amounts of money out of your own pocket.”50 president donald trump, who ran as a republican, proposed in campaign policy documents to expand consumer cost-sharing through healthcare spending accounts (hsas). trump advocated for tax advantages: “contributions into51 hsas should be tax-free and should be allowed to accumulate.” he also52 proposed that, “these funds can be used by any member of a family without penalty, and passed down to heirs without penalty.” president trump alludes to53 the future healthcare consumer’s exposure to costs when he notes “individuals should be able to shop to find the best prices for procedures, exams or any other medical-related procedure.” president trump also found political leverage in54 existing cost-sharing policy. his proposal to cut payments made by the federal government to insurers that reduce the cost-sharing burdens on low-income individuals—so called “cost-sharing subsidies”—would trigger greater out-ofpocket spending by those beneficiaries. as they stand today, these monthly 47. id. at 305. 48. transcript: obama's health care speech, cbsnews (sep. 9, 2009, 8:14 pm), http://www.cbsnews.com/news/transcript-obamas-health-care-speech/ [perma.cc/w5p8-smwg]. 49. id. 50. remarks by the president on health care reform, the white house: office of the press secretary (mar. 3, 2010, 1:50 pm), https://obamawhitehouse.archives.gov/the-pressoffice/remarks-president-health-care-reform [http://perma.cc/4p78-n652]. 51. donald j. trump, healthcare reform, donald j. trump for president 1, https://assets.donaldjtrump.com/hcreformpaper.pdf [https://perma.cc/jj45-dqjx] (last visited oct. 14, 2017). 52. id. 53. id. 54. id. at 2. 54 indiana health law review [vol. 15:43 payments to insurance companies reduce the copayments and deductibles charged to the low-income insured. such a willingness to discontinue these payments may be a signal of his receptiveness to increased cost sharing. paradoxically,55 however, president trump also called for (unspecified) policies that would feature “much lower deductibles. 56 a common ideological thread runs through many of these policy statements. healthcare waste is driven by over-insured patients demanding more healthcare than they really need, since they lack proper incentives to decline wasteful healthcare. thus, in order to moderate healthcare overuse and cost, the obvious solution has been to impose more costs on insured persons, creating such incentives. less frequent and more recent in this ideological history is the concern that cost-sharing may become so onerous that it impinges on access to care, and thus should be limited. no modern president has challenged the fundamental ideological premises that substantial health spending should be born individually rather than collectively. iii. the evidence on cost-sharing to evaluate this ideology, we briefly examine the experience of other countries, comparing their use of cost-sharing with their aggregate health spending. there is also a wealth of data from a landmark randomized experiment, and subsequent econometric work. finally, a range of studies from other scientific literatures shows that although cost-sharing does reduce some health spending it has onerous effects on poorer persons with chronic illnesses and has little or no effectiveness on the large-dollar care that drives most aggregate health spending. a. comparative data cost-control mechanisms fall into two broad categories: (1) “demand-side” interventions intended to change the behaviors of patients, and (2) “supply-side” interventions intended to change the behaviors of physicians, hospitals, drug manufacturers, and alike. countries generally exhibit a mix of demand-side and supply-side mechanisms, but the latter approach is more prominent outside the united states.57 although other developed countries do employ some patient-cost-sharing 55. alison kodjak, senate to hold bipartisan hearings to stabilize insurance markets, npr (aug. 1, 2017, 5:00 am), http://www.npr.org/sections/health-shots/2017/08/01/ 540656651/trumps-tweets-threaten-to-destabilize-insurance-markets [https://perma.cc/lv4t5ych]. 56. phillip bump, this is not the healthcare bill that trump promised, wash. post (may 4, 2017), https://www.washingtonpost.com/news/politics/wp/2017/05/04/this-is-not-the-healthcare-bill-that-donald-trump-promised/?utm_term=.caf0668bc28f [https://perma.cc/sck8-xf2m]. 57. randall p. ellis et al., comparisons of health insurance systems in developed countries, encyclopedia of health econ. (2014), http://www.bu.edu/law/files/2016/01/ ellispaper.pdf [https://perma.cc/py3x-w8n6]. 2018] ideology meets reality 55 features, they tend to have much lower spending overall and rarely deploy large and blunt cost-sharing mechanisms as are used in the united states. as one report summarizes, “exemptions from cost-sharing, or subsidies to help pay for cost sharing, are typically provided to low-income insurance subscribers, the chronically ill, and children. there are also usually caps or limits on the total outof-pocket expenses that different groups of subscribers can incur as a result of cost sharing.” in this way, cost-sharing is limited and roughly tailored to ability58 to pay. how effective are these comparative approaches to cost control? the commonwealth fund, using 2015 oecd data in conjunction with its own research, provides broad comparisons of the salient statistics and features of international health systems. in figure 1, we plot the total per capita healthcare59 spending for each country against the percentage of such costs that are borne outof-pocket. figure 1 shows that there is no simple relationship between these two60 variables. the horizontal axis shows that the united states is an outlier in terms of its total spending, spending far more than even the second and third-place countries. the vertical axis shows that other countries use as much or more costsharing as a percentage of total health spending, but since their total spending is much smaller, patients outside the u.s. generally pay much less in absolute dollars out of pocket. the overall slope of the data points suggests that greater proportional reliance on out-of-pocket spending is associated with higher health spending overall. we review some of these details for several countries. 58. steven globerman, select cost sharing in universal health care countries, fraser inst. (jan. 21, 2016), https://www.fraserinstitute.org/studies/select-cost-sharing-in-universalhealth-care-countries [https://perma.cc/wg3q-z99z]. 59. elias mossialos et al., 2015 international profiles of health care systems, the c o m m o n w e a l t h f u n d ( j a n . 2 0 1 6 ) , h t t p : / / www. c o mmo n we a l t h fu n d . org/~/media/files/publications/fund-report/2016/jan/1857_mossialos_intl_profiles_2015_v7.pdf. [https://perma.cc/m8k2-q4b8]. 60. id. 56 indiana health law review [vol. 15:43 the united states covers approximately one third of residents via publiclyfinanced programs, leaving roughly two-thirds covered via private insurance. the united states spent 17.1% of its gdp on health care, $9,086 per capita annually. as reviewed above, out-of-pocket spending in the united states takes many forms, generally manifested in deductibles, copayments, and coinsurance charges for both public and private insurance. average annual out-of-pocket health expenditures in the united states were $1,074 per person, or about 12% of the total. canada’s system is publicly-financed with many citizens purchasing supplemental private insurance that pays for upgrades and other benefits excluded from public coverage. it has no cost sharing for publicly-insured services. canada spent 10.7% of its gdp on health care, $4,569 per capita annually; roughly half of the u.s. spend per person. out-of-pocket spending in canada is primarily61 attributed to prescription drugs and nonhospital facilities. average annual out-ofpocket health expenditures in canada were $623 per person; about two-thirds of what the u.s. spends. as merely 14% of the total spending, the canadian proportion is comparable to u.s. out-of-pocket exposure, in these relative terms. germany provides publicly-financed, universal coverage for all legal residents. some choose to supplement or replace public coverage for private health insurance that offers access to more services. germany spent 11.2% of its gdp on health care, $4,920 per capita annually; slightly more than half of what the u.s. spends. out-of-pocket spending in germany is primarily for nursing62 facilities, pharmaceuticals, and home health. nominal copayments are charged for drugs, devices, and visits. average annual out-of-pocket health expenditures in germany were $649 per person; about two-thirds of the u.s. spending, but similar as a proportion (13% of the total spend). 63 france provides publicly-financed, universal health care that is compulsory. private health insurance in france is generally purchased as a complement to the public program. france spent 11.6% of its gdp on health care, $4,361 per capita annually; less than half of what the u.s. spends. the insured are responsible for64 use charges from copayments, coinsurance, and balance billing. coinsurance rates vary by how effective and beneficial the intervention is deemed to be. for example, insulin is not subject to coinsurance. copayments are nominal. average annual out-of-pocket health expenditures in france were $277 per person; less than one-third the u.s. level. 65 switzerland is an outlier in terms of cost-sharing, although it has universal, mandatory, publicly-financed health coverage. the country spent 11.1% of its66 gdp on health care, $6,325 per capita annually; similar to other developed 61. id. 62. id. 63. id. 64. id. 65. id. 66. id. private supplementary policies are available to provide access and choice beyond the statutory coverage. 2018] ideology meets reality 57 european countries and about two-thirds what the u.s. spends. the swiss can67 select between higher-deductible (lower-premium) plans and lower-deductible (higher-premium) plans. coinsurance is charged for all services above the deductible and those insured who choose brand-name drugs when a generic alternative is available are subject to additional charges. copayments are charged for hospital use. unlike most european countries, average annual out-of-pocket health expenditures in switzerland were very substantial, at $1,630 per person; half-again-more than the u.s spends, and more than double (26%) relative to total spending.68 we also have data on how consumers respond to the varying cost-sharing profiles in these countries. one recent survey found that “adults in the u.s. are far more likely than those in [the ten] other countries to go without needed [health] care because of costs.” more specifically, “[o]ne-third (33%) of u.s.69 adults went without recommended care, did not see a doctor when sick, or failed to fill a prescription because of costs.” other countries included in the survey,70 canada and germany as examples, reported markedly lower care avoidance rates—16% and 7% respectively. switzerland was the united states' nearest71 comparable case with 22% avoidance due to cost. this may come as no surprise72 given the swiss commitment to cost sharing. this brief comparative review suggests that, at the level of simply comparing total health spending between developed countries, the united states’ demandside strategy of making health insurance incomplete has not been resoundingly successful as a strategy of overall cost-containment. although in absolute dollars u.s. patients spend more out-of-pocket than twelve other countries (all but switzerland), they also have the highest overall health spending per capita. other countries, such as the netherlands, use cost-sharing for only 5% of total costs, compared to the 12% spent by the u.s., but also spend roughly half as much overall. although a much more granular analysis could examine differences in income and health outcomes, this top-level analysis does not support the73 proposition that increasing patient exposure to costs is generally associated with reductions in health spending overall. 67. id. 68. id. 69. robin osborn et al., in a new survey of 11 countries, u.s. adults still struggle with access to and affordability of health care, commonwealth fund (nov. 16, 2016), http://www.commonwealthfund.org/publications/in-the-literature/2016/nov/2016-internationalhealth-policy-survey-of-adults [https://perma.cc/nkf6-swv4]. 70. id. 71. id. 72. id. 73. see david orentlicher, controlling health care spending: more patient “skin in the game?”, 13 ind. health l. rev. 348, 350 (2016) (reviewing evidence that the united states trails comparable countries on these health indicators). https://doi.org/10.18060/3911.0019 58 indiana health law review [vol. 15:43 b. the rand health insurance experiment the rand health insurance experiment (hie) was a landmark field study in the 1970s that yielded great insight into how patients of that era responded to particular sorts of cost-sharing schemes. it was a remarkable social science74 endeavor. some patients were randomly assigned into a “free care” condition, with no cost-sharing burden. others were randomly assigned to one of several75 conditions with increasing levels of cost sharing up to a condition where the patient bore 95% of the cost-of-care out of pocket, though all were capped at 5% to 15% of household income. while the results of this gold-standard study have76 been scrutinized and recapitulated in a number of different forms over the years, its principal findings have served as lodestar for much of the subsequent work on cost sharing in healthcare. in a 2006 paper for the kaiser family foundation, gruber summarized the hie as finding that, “higher co-insurance rates, with an out-of-pocket limit, can significantly reduce health care use without sacrificing health outcomes for the typical person.” it is hard to overstate the impact of this headline finding on77 decades of health economics and health policy. this conclusion weakens, however, when considering the welfare of the sick and the poor. restating again that, “for individuals who were not already highrisk, there was little benefit to health from free care. for high-risk individuals, however, particularly if they were low income, there were important benefits to health from free care.” in short, the imposition of cost-sharing causes poorer78 patients to not consume healthcare that would have been beneficial to them. cost-sharing hurts sick and poor people. retrospective analyses have focused on the problem that some of the people recruited into the hie refused to participate and others left early, which could potentially bias the results. while nearly 95% of the free-care plan participants completed the experiment, only 84.6% of participants randomized to the highest cost-sharing arm remained in the study for the intended 3to 5-year period. this79 difference in attrition, with those exposed to comparatively higher cost sharing departing early, was statistically significant to the 1% level and driven by participants leaving the experiment voluntarily, not for other reasons such as death, joining the military, or becoming eligible for medicare. refusal rates at80 74. aviva aron-dine et al., the rand health insurance experiment, three decades later, 27 j. eco. persp. 197 (2013). 75. id. 76. id. at 201. 77. jonathan gruber, the role of consumer copayments for health care: lessons from the rand health insurance experiment and beyond 8 (the henry j. kaiser family foundation, 2006) [https://perma.cc/hz4n-dzgp]. 78. id. at 7. 79. aron-dine et al., supra note 74, at 202. 80. joseph p. newhouse, free for all? lessons from the rand health insurance experiment, 19, 24 (harvard univ. press 1996). https://doi.org/10.1257/jep.27.1.197 2018] ideology meets reality 59 the outset were also higher in the plans with cost-sharing. when refusal rates are aggregated with in-study attrition, 88% of the free-care plan participants completed the study compared to 63% in the highest cost-sharing arm. 81 in acknowledging this potential limitation, newhouse explained that “the additional refusal and attrition appear to have been random with respect to the characteristics of the participants, and therefore free of bias,” meaning that posthoc analyses were unable to discern the causes for the differential participation.82 still, the fact that the refusal rates differed so severely across experimental conditions suggests a form of adverse selection, whereby patients acted rationally on their private information, such that those most likely to suffer bad outcomes from cost-sharing would be most likely to refuse or depart from conditions that exposed them to high cost-sharing. if that happened, then the cost-sharing conditions would have unrealistically low estimates of adverse outcomes. other scholars, including john nyman, have argued that the hie was “biased by attrition and that the attrition accounts for the lack of a health effect from the reduction in health care use, especially hospitalizations, among the participants assigned to the cost-sharing arm.” 83 also notable was the hie's scaled cap-on-cost-sharing with a maximum dollar expenditure (mde). out-of-pocket costs ranged from 5, 10, and 15% of family income up to $1,000 in a given 12-month period. hence, no family would ever be responsible for more than $1,000 per year, no matter the study arm, and lower-income individuals faced less exposure than higher-income individuals. this understandable feature, designed to ensure that the randomization would not hurt any study participants, makes it perilous to make inferences about how costsharing works and in particular whether it hurts patients in the real world, where there are not typically income-scaled caps on cost-sharing exposure. this 84 problem of external validity has not, however, prevented scholars and policymakers from basing policy recommendations on the hie’s headline finding that cost-sharing can reduce waste without harming median patients. c. subsequent empirical evidence since the hie, there have been many other studies of cost-sharing, which show that it is much more complicated than economic theory might predict. we sample a few such studies here. in practice, cost-sharing in the u.s. has been linked to complications of the tax law. in particular, high-deductible health plans (hdhps) have been linked to “health savings accounts” (hsas), which can receive pre-tax contributions from employers and employees, and thereby create a corpus to pay non-insured health 81. aron-dine et al., supra note 74, at 202. 82. newhouse, supra note 80, at 366. 83. nyman, supra note 21, at 165. 84. see christopher t. robertson, scaling cost-sharing to wages: how employers can reduce health spending and provide greater economic security, 14 yale j. health pol'y l. & ethics 239 (2015). 60 indiana health law review [vol. 15:43 expenses. as scholars explain, “the tax advantaged account has the potential to buffer consumers from the increased financial liability, but it can undo the incentive to reduce unnecessary care (i.e., moral hazard).” a 2010 study85 examined insurer data for 56,809 enrollees from 2,380 employers in the smallgroup market, to identify the effects of hdhps and hsas on health care spending. the authors found that “the deductible has a predictable negative86 effect on total spending: each additional dollar increase in the deductible is associated with a 55-cent decrease in total spending, which corresponds to an elasticity of 0.23,” in the same ballpark as the rand experiment. on the other87 hand, “an additional dollar in the spending account is associated with a significant increase of $1.20 of total spending,” and these are predominately spent on outpatient visits and pharmaceuticals. when a plan makes equal increases “in88 the deductible and contribution to a spending account will increase total healthcare spending.” the authors speculate that this observation is driven by89 healthy people spending more in the setting of a higher hsa balance, while sicker people, who anticipate exceeding their deductible and exhausting their hsa, are unaffected. 90 most of the recent and compelling evidence on the effects of cost-sharing comes from natural experiments. one paper, followed the employees of a large, self-insured firm (with very highly-paid employees) as it changed from a free care model to a high-deductible health plan. researchers found that when exposed91 to more out-of-pocket risk, employees reduced overall spending by about 12.5%. interestingly, despite this cohort’s relatively high income, level of education, and access to a price-shopping tool, nearly all savings were derived from simple reductions in quantity—not substitution for a more appropriate product, and not via shopping for a more competitive price. employees seemed to reduce their consumption indiscriminately, without consideration for the differences between care that could be described as valuable, such as preventive care, and care that may be wasteful, such as orthopedic (joint) mri. this evidence bodes poorly for achieving dramatic cost savings by empowering patients with more information or the ability to shop. in 2004, another employer, alcoa, changed their healthcare coverage by eliminating cost sharing for preventive care while increasing cost sharing for other services. specifically, for most of alcoa's non-union employees, the92 85. anthony t. lo sasso et al., the effects of consumer-directed health plans on health care spending, 77 j. of risk and insurance 85, 86 (2010). 86. id. at 92. 87. id. at 97. 88. id. 89. id. at 101. 90. id. 91. zarek c. brot-goldberg et al., what does a deductible do? the impact of cost-sharing on health care prices, quantities, and spending dynamics, 132 q. j. of econ. 1261, 1272 (2017). 92. susan h. busch et al., effects of a cost-sharing exemption on use of preventive services at one large employer, 25 health aff. 1529 (2006). https://doi.org/10.1111/j.1539-6975.2009.01346.x https://doi.org/10.1093/qje/qjx013 https://doi.org/10.1377/hlthaff.25.6.1529 2018] ideology meets reality 61 company changed from a $10-$15 copayment to a 10% coinsurance rate, and from a zero deductible to a $1,500 deductible. susan busch and colleagues studied the transformation and found “a 5 percent reduction in total costs among affected enrollees, compared with a 4 percent rise in total costs in the comparison group” [in the first year]. they also observed that the cost-sharing reduction for93 preventative care had “little impact on preventative care use,” suggesting the need for “greater health education campaigns or even stronger financial incentives” to increase the use of these services. this study did not allow researchers to94 investigate whether cost-sharing caused patients to discriminate between high and low value care, nor did it allow observation of the effects on health outcomes. other studies have shown that cost-sharing has a significant impact on preventative care. an analysis of a 1994 survey of insured employees found that cost sharing resulted in lower utilization of clinical preventive services. in95 another study, when an hmo introduced a nominal, $5 copayment for office visits, primary care visits dropped by an estimated 10.9%. these sorts of data96 were influential in causing the affordable care act to mandate free coverage of preventative care services. a 2014 commonwealth fund survey found that “nearly one-quarter of people with high deductibles cited them as the reason they had not gotten a preventative care test, even though by law these tests are excluded from deductibles.” this97 survey also found that copayments and coinsurance had a significant effect on the care sought by the insured, particularly those with low incomes. nearly half (46%) of insured adults with incomes under 200 percent of poverty said that because of their copayments or coinsurance, they had either not filled a prescription, not gone to the doctor when they were sick, skipped a medical test or follow-up visit recommended by a doctor, or not seen a specialist when they or their doctor thought they needed one.98 cost-sharing has a disparate impact on patients with chronic conditions. a 2004 jama paper studied the effect of doubling copayments on the use of prescription drugs. the authors found that many classes of medications were99 93. id. at 1531. 94. id. at 1534. 95. geetesh solanki & helen halpin schauffler, cost-sharing and the utilization of clinical preventive services, 17 am. j. preventive med. 127 (1999). 96. daniel c. cherkin et al., the effect of office visit copayments on utilization in a health maintenance organization, 27 med. care 1036, 1040 (1989). 97. sara r. collins et al., too high a price: out-of-pocket health care costs in the united states, commonwealth fund (nov. 13, 2014), at 1, 8. see also sara r. collins et al., the problem of underinsurance and how rising deductibles will make it worse, commonwealth fund, may 20, 2015, at 1. 98. collins, too high a price: out-of-pocket health care costs in the united states, supra note 97, at 6. 99. dana p. goldman et al., pharmacy benefits and the use of drugs by the chronically ill, https://doi.org/10.1016/s0749-3797(99)00057-4 https://doi.org/10.1097/00005650-198911000-00005 https://doi.org/10.1001/jama.291.19.2344 62 indiana health law review [vol. 15:43 sensitive to increases in out-of-pocket expenses. most notably, “the populations100 most sensitive to price changes were the patients taking long-term medications but who were not receiving ongoing care for the condition.” there was also101 evidence that “copayment increases led to increased use of emergency department visits and hospital days for the sentinel conditions of diabetes, asthma, and gastric acid disorder: predicted annual emergency department visits increased by 17% and hospital days by 10%.” the authors caution that the estimates for increased102 visits are not definitive as they rely on limited data. in this study, the authors103 were not privy to the coverage and benefit plans faced by the participants and, as a result, unable to control for that variation. 104 an analysis by kenneth thorpe shows that cost-sharing for prescription drugs may be counterproductive for patients with chronic conditions. he105 demonstrates that while higher copayments and coinsurance rates reliably reduce spending on the drugs themselves, the effect on overall spending was less reliable. thorpe found that in patients with multiple chronic conditions,106 increased cost sharing led to non-adherence and an overall greater level of spending when these patients eventually sought care in an emergency room, clinic, or hospital for exacerbations of their chronic illnesses. 107 in a similar vein, a 2010 cross-sectional study followed nearly 150,000 type-2 diabetic patients, examining both their cost-sharing exposure and their adherence to insulin and oral antidiabetic medicines. in a second stage, the authors108 examined the association between lack of adherence and complications, including health outcomes such as neuropathy, as well as medical service utilization and workplace productivity. the authors found that a $10 increase in patient cost-109 sharing was associated with a 5-6% reduction in adherence, which then substantially worsened health outcomes and led to emergency room visits.110 another recent study of individuals in high-deductible health plans focused on emergency room visits, and distinguished between appropriate utilization for high-severity incidents and inappropriate utilization for low-severity incidents. the study found that when patients are moved to high-deductible health plans, poorer patients, but not richer patients, dramatically reduce the amount of high291 jama 2344 (2004). 100. id. 101. id. at 2349. 102. id. 103. id. 104. id. 105. kenneth e. thorpe et al., out-of-pocket prescription costs under a typical silver plan are twice as high as they are in the average employer plan, 34 health aff. 1695 (2015). 106. id. 107. id. 108. theresa b. gibson et al., cost sharing, adherence, and health outcomes in patients with diabetes, 8 am. j. managed care 589 (2010). 109. id. 110. id. https://doi.org/10.1377/hlthaff.2015.0323 2018] ideology meets reality 63 severity (appropriate) emergency care they consumed. 111 this evidence, which demonstrates negative effects of cost-sharing, especially among the poor and chronically ill, is consistent with the theory of “underinsurance.” when a person has so much exposure to the financial risk associated with medical problems, the core functions of health insurance are undermined. access to care is denied, and financial distress looms for healthcare consumed. notwithstanding this conceptual framework, it is challenging to operationalize and test for underinsurance in the population. more than 30 years ago, farley used strictly empirical criteria to proposed three alternative definitions for underinsurance. if a person who makes $60,000 a year has a 1% chance of spending $6,000 on health services, that person would be considered underinsured by farley's intermediate definition. more recently, schoen and112 colleagues offer strictly income-based financial inclusion criteria, tallying amongst the underinsured those with out-of-pocket expenses equal to at least 10% of income, low-income respondents (income below 200% of the federal poverty level) with medical expenses equal to at least 5% of income, and those with deductibles equal to at least 5% of income. indicators of underinsurance with113 the most pronounced movement coming from the 10% of income and deductible indicators. these authors concluded that “insurance erosion has spread up the income distribution well into the middle-income range.”114 scholars have raised an intriguing challenge to these definitions of underinsurance, which depend on observed out-of-pocket spending, arguing that they fail to incorporate the increased consumption that would be caused by more generous health insurance coverage, which allowed people to consume the healthcare they truly need. accounting for this problem can dramatically115 increase estimates of underinsurance among populations that have less-generous health insurance policies. for example, although households with small group health plans tend to have less generous insurance compared to those in large group plans, in one dataset, they appeared to be 10% less likely to suffer from underinsurance. when the increased consumption is taken into account, the smallgroup households’ underinsurance rate is actually 33% greater than large-group households, as we might expect. there is also a growing empirical literature showing onerous effects of costsharing on personal finances, which may also impact health. david himmelstein and colleagues studied debtors going through the process of bankruptcy, and 111. j. frank wharam et al., low-socioeconomic-status enrollees in high-deductible plans reduced high-severity emergency care, 32 health aff. 1398 (2013). 112. pamela j. farley, who are the underinsured?, 63 milbank memorial fund q. health & soc’y. 476, 476 (summer 1985). 113. cathy schoen et al., how many are underinsured? trends among u.s. adults, 2003 and 2007, 27 health aff. 646, 647 (2008). 114. id. at w301. 115. jean marie abraham et al., moral hazard matters: measuring relative rates of underinsurance using threshold measures, 45 health servs. res. 806 (2010). https://doi.org/10.1377/hlthaff.2012.1426 https://doi.org/10.2307/3349844 https://doi.org/10.1377/hlthaff.27.4.w298 https://doi.org/10.1111/j.1475-6773.2010.01084.x 64 indiana health law review [vol. 15:43 found that 62% cited medical causes of their financial problems. this work116 evinces the negative feedback loops associated with illness – it is not uncommon for a medical problem to cause a loss of income in the household, because the sick person cannot work and/or another member of the family loses work while caring for them. accordingly, of those medical debtors, over 92% had over $5,000 in medical debt or medical debts exceeding 10% of income. christina cutshaw and colleagues surveyed people going through home foreclosure, and found similar rates of medical causes. they also found that the foreclosure117 process itself had negative impacts on health, as it caused stress, worsened unhealthy behaviors, and disrupted treatment relationships.118 iv. conclusions consumer cost sharing is effectively the absence of insurance. since the advent of medicare, the importance of consumer cost sharing has been a recurring political theme, and was seen as a means for reducing the excess demand that comes along with an insured population. u.s. politicians were motivated by a sentiment that end-users of healthcare must share in the cost to understand there is a cost. these sentiments have pushed this agenda for decades, unlike their counterparts in other countries. this emphasis is understandable, given that academic economists have built contemporary health insurance theory around moral hazard and the alleged welfare loss that results from over-insurance, while largely overlooking the ways that health insurance expands access to high-value healthcare that would otherwise be unaffordable to individuals. the evidence suggests that the classic models do hold some truth. studies like the rand hie and others have shown that healthcare spending is sensitive to out-of-pocket costs. notwithstanding its external validity and selection problems, designers of insurance contracts have keyed-in on consumers’ rand-proven sensitivity to cost and have increasingly sought to reduce health insurance coverage accordingly. a broader literature has shown how greater exposure to cost erodes the value of the insurance contract and, depending on the extent of the cost sharing, can undermine its essential function, creating underinsurance. the data shows consistently that, in response to rises in out-of-pocket costs, consumers cut their spending indiscriminately, seemingly without the ability to discern whether a service or test is of high or low relative value. after all, that function of discernment is what physicians are for. the future of scholarship and policymaking should focus on ways to better tailor this policy tool, so that it achieves its cost-reduction benefits without harming patients. the move towards value-based insurance design--reducing 116. david u. himmelstein, medical bankruptcy in the united states, 2007: results of a national study, 122 am. j. med. 741 (2009). 117. christina a. cutshaw et al., medical causes and consequences of home foreclosures, 46 int’l. j. health servs. 36 (2015). 118. id. https://doi.org/10.1016/j.amjmed.2009.04.012 https://doi.org/10.1177/0020731415614249 2018] ideology meets reality 65 or eliminating copays for high-value care--tries to do exactly that. cost-119 sharing must also respond to patient-heterogeneity, including differences in ability to pay between the rich and the poor, and differences in need for healthcare between those chronically ill versus others. ultimately, as the comparative perspective suggests, cost-sharing cannot be our only tool. scholars and policymakers must do more to align incentives on the supply-side, recognizing that for the high-cost care that drives most health spending, patient cost-sharing can have limited impact. in precisely those domains, the producers have the greatest temptation to drive up costs and prices, unless policymakers do a better job of aligning their incentives with patient health and payor thrift. 119. michael e. chernew et al., value-based insurance design, in 3 encyclopedia health econ. 446 (anthony j. cuyler et. al. eds., 2014). microsoft word 1-volume xii masthead.docx from sars to ebola: legal and ethical considerations for modern quarantine mark a. rothstein∗ i. introduction .................................................................. 227 ii. a brief history of quarantine .................................. 229 iii. quarantine and other social distancing measures ............................................................................ 234 iv. legal authority ......................................................... 239 a. legislation ................................................................... 239 b. case law ..................................................................... 246 v. an ethics framework ................................................ 249 a. necessity, effectiveness, and scientific rationale ... 250 b. proportionality and least infringement ................... 254 c. humane supportive services .................................... 263 d. public justification .................................................... 267 vi. ebola quarantine in liberia ................................... 273 vii. conclusion ............................................................... 278 i. introduction quarantine is the restriction of the movement of asymptomatic persons with possible exposure to a communicable disease during its period of communicability to prevent disease transmission.1 by contrast, isolation is the separation for the period of communicability of known infected persons to prevent the transmission of the infectious agent.2 quarantine is one of the most aggressive ∗ herbert f. boehl chair of law and medicine and director, institute for bioethics, health policy and law, university of louisville school of medicine. nicholas craddock, j.d. 2014, provided excellent research assistance. 1 lawrence o. gostin, public health law: power, duty, restraint 429 (2d ed. 2008). 2 id. http://dx.doi.org/10.18060/18963 228 indiana health law review vol. 12:1 and controversial measures public health officials have at their disposal in attempting to control a disease outbreak, because restricting the movement of potentially large numbers of asymptomatic people raises serious legal and ethical concerns.3 with the notable exceptions of the severe acute respiratory syndrome (sars) outbreak in 20034 and the ebola virus disease outbreak in 2014,5 quarantine has not been used on a large scale since the first half of the twentieth century. nevertheless, quarantine remains an important part of the infectious disease containment strategy of the united states and virtually every country.6 therefore, it is appropriate to reflect on the use of quarantine in the past and to explore the legal and ethical considerations for using quarantine in the twenty-first century. part ii of this article contains a brief history of quarantine. part iii considers various social distancing measures, including voluntary and legally ordered quarantine. part iv discusses the legal authority for quarantine, including constitutional provisions, statutes, and leading cases. part v presents an ethics framework for quarantine, emphasizing the following four considerations: (1) necessity, effectiveness, and scientific rationale; (2) proportionality and least infringement; (3) humane supportive services; and (4) public justification. part vi uses the ebola quarantine in liberia as a case study of the dire consequences that follow from a quarantine that fails to 3 see david p. fidler et al., through the quarantine looking glass: drug-resistant tuberculosis and public health governance, law, and ethics, 35 j.l. med. & ethics 616, 616 (2007). 4 see timeline: sars outbreak, cnn.com (apr. 24, 2003, 8:29 am), archived at http://perma.cc/84tq-79ex. 5 compare world health organization, ebola information, archived at http://perma.cc/p7kw-4lul (stating that fatality rates are 50%) with who ebola response team, ebola virus disease in west africa – the first 9 months of the epidemic and forward projections, 371 new eng. j. med. 1481 (2014) (indicating ebola case fatality rate is 70.8%). 6 see dep’t of health & human servs., hhs pandemic influenza plan (2005), http://www.hhs.gov/pandemicflu/plan/, archived at http://perma.cc/jn59-ygtt/. http://dx.doi.org/10.1111/j.1748-720x.2007.00185.x http://dx.doi.org/10.1056/nejmoa1411100 2015 from sars to ebola 229 address essential ethical considerations. part vii concludes by reiterating the significance of ethical considerations in modern quarantine. ii. a brief history of quarantine the practice of quarantine dates to antiquity. quarantine for leprosy is mentioned in the old testament;7 quarantine for other diseases was discussed by hippocrates and other greek scholars in the fourth century b.c.e.8 in the middle ages, quarantine probably began in venice between the twelfth9 and fourteenth10 centuries, where its name undoubtedly originated. the term “quarantine” is derived from the italian quaranta giorni, meaning forty days, the time within which it was believed people stricken with the plague would either die or recover and become noninfectious.11 thus, ships arriving in the port of venice were required to wait at anchor for forty days before unloading their passengers, crew, and cargo. most experts believe venice established the first quarantine station, or lazaretto (named after st. lazarus), on the island of santa maria di nazareth in the early 1400s, 12 although there is some support for the earlier establishment of quarantine 7 leviticus 14:4-8. 8 howard markel, quarantine! east european jewish immigrants and the new york city epidemic of 1892 2–3 (1997); gian franco gensini et al., the concept of quarantine in history: from plague to sars, 49 j. infection 257, 258 (2004). 9 frank g. clemow, origin of quarantine, 1 brit. med. j. 122, 123 (1929). 10 markel, supra note 8, at 3. but see eugenia tognotti, lessons from the history of quarantine, from plague to influenza a, 19(2) emerging infectious diseases 254, 254 (2013) (asserting that quarantine was first introduced in dubrovnik in 1377). 11 fidler et al., supra note 3, at 619. it is not known why forty days was chosen as the length of time for quarantine. among the theories are that it was derived from hippocratic theories of illness, pythagorean numbers theory, and the biblical account of jesus wandering in the desert for forty years. see tognotti, supra note 10, at 254. see generally oleg p. schepin & waldemar v. yermakov, international quarantine (1991). 12 markel, supra note 8, at 3; gensini et al., supra note 8, at 259. http://dx.doi.org/10.1016/j.jinf.2004.03.002 http://dx.doi.org/10.1136/bmj.1.3564.790-a http://dx.doi.org/10.3201/eid1902.120312 230 indiana health law review vol. 12:1 stations. 13 from its origins along the adriatic coast, quarantine soon became an established public health practice recognized by law throughout europe.14 european legal traditions, as well as diseases, were brought to the american colonies. the earliest law providing for quarantine was enacted by the massachusetts bay colony in 1647 to quarantine ships from the west indies due to the threat of plague.15 the quarantine power was especially important in port cities, such as new york and boston, where the most common health threats were yellow fever and cholera.16 some cities required medical examinations before passengers could enter.17 these local and state quarantine laws predated the drafting of the united states constitution,18 thereby establishing the legal tradition of local and state jurisdiction over matters of public health reflected in the constitution’s reservation of power to the states to regulate public health, safety, and morals.19 initial federal government involvement in quarantine was greatly influenced by the yellow fever epidemic of 1793, which was so virulent and widespread in the then capital of philadelphia that it threatened the survival of the nation.20 the entire city of philadelphia was under quarantine, martial law was declared, and residents were prohibited from traveling to other cities, such as baltimore and new york. 21 in 1796, congress enacted the first federal 13 clemow, supra note 9, at 123. 14 see paul s. sehdev, the origin of quarantine, 35 clinical infectious diseases 1071, 1072 (2002). 15 felice batlan, law in the time of cholera: disease, state power, and quarantine past and future, 80 temp. l. rev. 53, 63 (2007). 16 id. at 64; see also michael les benedict, contagion and the constitution: quarantine agitation from 1859 to 1866, 25 j. hist. med. & allied sci. 177, 178 (1970). 17 batlan, supra note 15, at 64. 18 see id. at 63. 19 gibbons v. ogden, 22 u.s. 1 (1824). 20 see generally jim murphy, an american plague: the true and terrifying story of the yellow fever epidemic of 1793 (2003). 21 see generally j.h. powell, bring out your dead: the great plague of yellow fever in philadelphia in 1793 (1993). http://dx.doi.org/10.1086/344062 http://dx.doi.org/10.1093/jhmas/xxv.2.177 2015 from sars to ebola 231 quarantine law, which authorized the federal government to assist the states with quarantine.22 the federal government sought to expand its quarantine powers after the civil war, but early laws were weak and met with significant resistance from the states.23 in 1878, congress enacted the national quarantine act,24 the first major federal quarantine law, in response to persistent outbreaks of yellow fever along the mississippi river.25 the law created a quarantine division within the marine hospital service and authorized the surgeon general to issue quarantine regulations that did not conflict with state laws. 26 during the next several years federal laws established quarantine stations, required medical examinations of immigrants, and gave financial incentives to states that used federal quarantine facilities.27 in 1944, congress enacted the public health service act,28 which consolidated the federal government’s quarantine powers over the movement of goods and people in interstate and foreign commerce. the centers for disease control and prevention (cdc) has been responsible for federal quarantine since 1967.29 despite its ancient origins, quarantine remains an important tool for public health officials in fighting epidemics.30 during the 1918-1919 spanish flu pandemic, 22 act of may 27, 1796, ch. 31, 1 stat. 474 (repealed 1799). 23 batlan, supra note 15, at 64–65; les benedict, supra note 16, at 190–92. 24 act of june 14, 1879, no. 6, 21 stat. 50 (1879) (current version at 42 u.s.c. § 98 (2012)). 25 history of quarantine, ctrs. for disease control and prevention, http://www.cdc.gov/quarantine/historyquarantine.html, archived at http://perma.cc/2z8z-tzve. 26 batlan, supra note 15, at 65. 27 id. at 66–67. 28 public health service act of 1944, pub. l. no. 78-410, 58 stat. 682 (current version at 42 u.s.c. §§ 201-300hh (2000)). 29 history of quarantine, supra note 25. 30 see, e.g., e. delaporte et al., large measles outbreak in geneva, switzerland, january to august 2011: descriptive epidemiology and demonstration of quarantine effectiveness, 18 euro. surveillance no. 6 (2013), available at http://www.eurosurveillance.org/ viewarticle.aspx?articleid=20395, archived at http://perma.cc/a3dl232 indiana health law review vol. 12:1 “nonpharmaceutical interventions,” including quarantine, were successful in decreasing case fatality rates.31 during the sars epidemic of 2003, quarantine was used extensively in several asian countries and canada. in the absence of a vaccine or effective treatment quarantine played a part in ending the epidemic. similarly, during the ebola epidemic of 2014 in west africa, with no vaccine or widely available treatment, and a mortality rate of approximately seventy percent, 32 social distancing measures, including quarantine, became a primary containment strategy. the social distancing measures included school closures and bans on public gatherings, including sports, shopping, and entertainment. 33 the quarantines were both individually based34 and area-wide (or cordon sanitaire).35 public health challenges also may be created by quarantine, as illustrated during the sars epidemic. with several hundred thousand individuals placed in quarantine and relatively few of them later developing sars, local public health officials later acknowledged that the response was disproportionate to the threat.36 thus, the paradox of quarantine and other social distancing measures is that they may be effective in fighting a disease outbreak, but they can be applied too broadly, resulting in a variety of kcj2/; david m. morens et al., what is a pandemic?, 200 j. infectious diseases 1018, 1019–20 (2009). 31 howard markel et al., nonpharmaceutical interventions implemented by u.s. cities during the 1918–1919 influenza pandemic, 298 jama 644, 644 (2007). 32 see world health organization, supra note 5. 33 lawrence o. gostin et al., the ebola epidemic: a global health emergency, jama, aug. 11, 2014, archived at http://perma.cc/fzq5dzs9. 34 adam nossiter, lax quarantine undercuts ebola fight in africa, n.y. times, aug. 5, 2014, at a1, archived at http://perma.cc/p5znrfg6. 35 donald g. mcneil, jr., using a tactic unseen in a century, countries cordon off ebola-racked areas, n.y. times, aug. 12, 2014, at a10, archived at http://perma.cc/vh6c-fs94. 36 see infra text accompanying notes129-130. http://dx.doi.org/10.1086/644537 http://dx.doi.org/10.1001/jama.298.19.2264-c http://dx.doi.org/10.1001/jama.2014.11176 2015 from sars to ebola 233 social harms, including economic disruption, personal isolation, and even violence.37 historically, quarantine was a measure borne of scientific uncertainty or outright ignorance. the original forty-day period of quarantine to prevent the spread of the plague bears no relation to the period of incubation for either bubonic (two to ten days) or pneumonic (one to two days) plague, 38 and it reflects early experience with the disease process of infected individuals. thus, early social distancing measures often were an ill-defined combination of both quarantine and isolation. today, even when evidence of the effectiveness of quarantine is unclear, public health or elected officials often choose to err on the side of caution and order quarantine. for example, sars involved a previously unknown pathogen with an originally unclear etiology and limited therapeutic options. under these circumstances an aggressive public health response was predictable. “the impulse for aggressive quarantine is, of course, greatest for those contagious diseases whose terms of transmission remain poorly understood. any and all precautions against its spread seem reasonable during such crises.”39 yet, as discussed below, a public health or government official’s “aggressive impulse” sometimes can be counterproductive to 37 norimitsu onishi, clashes erupt as liberia sets a quarantine, n.y. times, aug. 21, 2014 at a1, archived at http://perma.cc/t2tnza5j. 38 markel, supra note 8, at 198 n.10. there are three types of plague: bubonic, pneumonic, and septicemic. all three are caused by the bacterium yersinia pestis. bubonic plague is caused by the bites of fleas that live on small rodents and other animals. the infection enters through the skin and travels through the lymphatic system. pneumonic plague is a rarer and more lethal form of the infection, which may be spread from human-to-human by inhalation of infected droplets. untreated, pneumonic plague causes a respiratory infection with an extremely high mortality rate. septicemic plague, which manifests as a deadly infection of the blood, may be spread through flea bites or handling infected animals. plague, ctrs. for disease control and prevention, www.cdc.gov/plague/symptoms, archived at http://perma.cc/wb2a-xr8b. 39 markel, supra note 8, at 48. 234 indiana health law review vol. 12:1 achieving public health goals in responding to an emergency. this brief excursion into the history of quarantine illustrates three points of continuing importance: (1) quarantine is a long-standing public health intervention that was originally used – and still may be used – when medical countermeasures are unknown, ineffective, or unavailable; (2) in the united states, quarantine began at the local and state level, which is still the practice today, although there is a federal role in coordination, technical support, and prevention of the interstate and international spread of contagion; and (3) although quarantine remains an effective measure, because of its significant implications for civil liberties, economic activity, and social cohesion officials must exercise great care not to overuse their quarantine powers. iii. quarantine and other social distancing measures outbreaks of the most pathogenic infectious diseases, such as the 1918-1919 spanish flu,40 often spread through close contact, 41 and therefore several public health measures have been used to limit such contact. these measures include not only quarantine, but closing public facilities, especially schools, and canceling events attended by groups or large numbers of people.42 “social distancing” is the modern term applied to various mandatory and recommended strategies to limit close contact.43 40 john m. barry, the great influenza: the story of the deadliest pandemic in history 345, 359 (2004). 41 robert j. glass et al., targeted social distancing design for pandemic influenza, 12 emerging infectious diseases 1671, 1671 (2006). 42 see id. at 1675. 43 see id. at 1671. http://dx.doi.org/10.3201/eid1211.060255 2015 from sars to ebola 235 social distancing measures cordon sanitaire (area quarantine): the limitation of entry into or out of a geographic area where a contagious disease exists. these measures have been rarely used in the united states, a notable exception being in chinatown in san francisco in 1900. cordon sanitaire was used more extensively in china during the sars epidemic and in liberia during the ebola epidemic. isolation: the separation, for the period of communicability, of known infected persons to prevent the transmission of the infectious agent. isolation is easier to justify and enforce than quarantine because it usually involves smaller numbers of individuals and people with symptoms are generally willing to be isolated for treatment. quarantine: restricting the activities or movement of asymptomatic individuals who may have been exposed to a communicable disease for the duration of the period of communicability. shelter in place: a generally nonmandatory effort to limit personal exposure in a community by asking individuals to remain in their homes, schools, or work locations while a threat exists. this is also referred to as a “snow day.” work quarantine: an attempt to deal with health care worker staff shortages during epidemics, it asks or perhaps requires health care workers to work in certain hospital units while wearing recommended personal protective equipment. they also should maintain standard quarantine procedures at home and avoid public transportation.44 44 gene w. matthews et al., legal authorities for interventions in public health emergencies, in law in public health practice 272 (richard a. goodman et al. eds., 2d ed. 2007). 236 indiana health law review vol. 12:1 of the social distancing measures, quarantine is the most intrusive upon individual liberty and therefore raises the greatest number of ethical, legal, and policy issues. quarantine may involve large numbers of asymptomatic individuals sequestered in their homes or other locations, either voluntarily or pursuant to a legal order. for the duration of the quarantine, ranging from a few days to a few weeks, quarantined individuals are unable to work, attend school, or maintain their normal social interactions. 45 family members may be separated and individuals may be forced to cope with an extremely stressful situation during the quarantine. furthermore, individuals may have difficulty adjusting after the quarantine has ended. 46 quarantine also can be extraordinarily disruptive on a societal basis, and it may cause, among other things, severe economic disruptions.47 although the impulse of many public health officials is to quarantine every possible at-risk individual, as a scientific matter, it is not necessary to quarantine all or nearly all potentially exposed individuals. the initial purpose of quarantine is to slow the number of new infections to below the total number of deaths plus the total number of people who have recovered in a discrete period of time. to be successful, it is not necessary for a quarantine to eliminate all new cases immediately. thus, even a “leaky quarantine” is valuable and has utility in the public health response to an epidemic.48 moreover, limiting the number of people subject to quarantine minimizes the individual, economic, and societal disruption of the epidemic and furthers the essential policy of maintaining public support for public health measures, as well as fostering social solidarity. quarantine strategy should be flexible and tailored to the specific nature of the public health threat. in the 45 see generally laura hawryluck et al., sars control and psychological effects of quarantine, toronto, canada, 10 emerging infectious diseases 1206 (2004). 46 id. at 1210. 47 see lawrence o. gostin & benjamin e. berkman, pandemic influenza: ethics, law and the public’s health, 59 admin. l. rev. 121, 169 (2007). 48 matthews et al., supra note 44, at 272. http://dx.doi.org/10.3201/eid1007.030703 2015 from sars to ebola 237 context of influenza, dr. martin cetron, director of the cdc's division of global migration and quarantine, and dr. julius landwirth of the yale interdisciplinary center for bioethics, advised: [a]t a stage when transmission of a novel influenza virus is still limited, either abroad or in the area, and local cases are either imported or have clear epidemiological links to other cases, individual quarantine of close contacts may be effective. at a more advanced stage of the pandemic, however, when virus transmission in the area is sustained and epidemiological links to other cases is unclear, limiting quarantine to exposed individuals may be ineffective, and the strategy may need to expand to include community-based interventions that increase social distance. these include school closings, cancellation of public gatherings, encouraging non-essential workers to stay home, and reduced holiday transportation schedules. if these measures are believed to be ineffective, community-wide quarantine may need to be implemented.49 quarantine and other social distancing measures may be voluntary or legally mandated. voluntary quarantine has some important advantages over mandatory quarantine. voluntary measures are less coercive for individuals and families;50 they also place fewer demands on public health agencies, the courts, and law enforcement to obtain and enforce quarantine orders. 51 voluntary quarantine also eliminates possible claims of governmental overreaching or 49 martin cetron & julius landwirth, public health and ethical considerations in planning for quarantine, 78 yale j. biology & med. 325, 326 (2005). 50 ross upshur, the ethics of quarantine, 5 virtual mentor 1, 1– 3 (2003). 51 see lawrence o. gostin et al., quarantine: voluntary or not?, 32 j.l. med. & ethics 83, 83–84 (2004). http://dx.doi.org/10.1001/virtualmentor.2003.5.11.msoc1-0311 http://dx.doi.org/10.1111/j.1748-720x.2004.tb00196.x 238 indiana health law review vol. 12:1 discriminatory enforcement, thereby helping to maintain public support during a time of societal stress or calamity.52 on the other hand, it is not clear whether compliance rates for voluntary quarantine are equivalent to those for mandatory quarantine.53 typically, voluntary quarantine is recommended by an authorized public health official who announces a declaration, guideline, or request that a certain group of individuals (e.g., people in a high-risk group, a certain geographic area, or those with possible disease exposure) remain at home or at designated areas for a specific period of time. the announcement also usually provides information about the symptoms of the disease to be monitored, where to go and what to do if symptoms appear, and what public services are available to aid individuals in quarantine. these services include food, medications, other supplies, and information about control of the disease. by contrast, a mandatory quarantine is more strictly governed by laws and regulations setting out the authority of public health officials and other government authorities. it is more explicit in terms of the procedures and evidence used to reach the decision, the quarantine order’s specific applicability, and its duration. because quarantine often causes hardships and because many americans are distrustful of the government and are prepared to exercise their legal rights, some quarantine orders are likely to be challenged in court. if the orders are challenged, the contested legal issues may include the statutory authority for quarantine, the burden of proof, the court procedures, and the methods authorized to enforce a quarantine order in the event of noncompliance. finally, as noted earlier, quarantine was originally developed as a public health strategy because there was inadequate knowledge about which individuals were exposed to the infectious agent; of those exposed, which individuals were most likely to become infected; and of those infected, which were most likely to recover or to become seriously ill or die. new technologies, especially 52 see upshur, supra note 50, at 1–3. 53 gostin et al., supra note 51, at 83. 2015 from sars to ebola 239 those based on genomics, in the reasonably foreseeable future might provide additional information, such as individual genetic susceptibility to particular infections, likely positive or adverse responses to vaccine, likelihood of infecting other individuals, likely response to possible treatment, and expected severity of illness. 54 these emerging developments in “personalized medicine” raise the prospect of a new, individually based, public health paradigm for resource allocation, prevention, treatment, and containment – including quarantine – to protect the health of the public.55 the further exploration of these issues is beyond the scope of this article. iv. legal authority a. legislation primary responsibility for public health policy, funding, staffing, and enforcement is vested in the states.56 each state has its own public health act authorizing state government officials and health department personnel to take specified measures to protect the health and safety of the public.57 in every state these measures are authorized pursuant to the state’s police powers.58 the actions include quarantine and isolation, vaccination, disease reporting, travel restrictions, contact tracing, medical examination and treatment, and property seizures. in the event of a public health emergency involving a communicable disease, 54 see, e.g., jonathan a. eisen & catriona j. maccallum, genomics of emerging infectious disease: a plos collection, 7 plos biology 1, (oct. 2009), archived at http://perma.cc/e2g5-2zm8/. 55 see, e.g., genetics and public health in the 21st century: using genetic information to improve health and prevent disease (muin j. khoury et al. eds., 2000). 56 gostin, supra note 1, at 91. 57 state quarantine and isolation statutes, nat’l conference of state legislatures, www.ncsl.org/issues-research/health/statequarantine-and-isolation-statutes.aspx, archived at http://perma.cc/9ffz-gzj2. 58 gostin, supra note 1, at 95. see jacobson v. massachusetts, 197 u.s. 11 (1905) (upholding mandatory smallpox vaccination under state police powers). http://dx.doi.org/10.1371/journal.pbio.1000224 240 indiana health law review vol. 12:1 state public health officials working with their local counterparts are responsible for determining whether and how to impose quarantine in accordance with the substantive and procedural requirements of state law. in most states, the authority to use quarantine and similar measures begins when the governor or other public official declares a public health emergency. after the events of september 11, 2001 and the anthrax incidents that followed shortly thereafter, public concern about the country’s vulnerability to bioterrorism provided the impetus to update and revise state public health laws. many of these laws, including their quarantine provisions, were enacted at the turn of the twentieth century. with support from the cdc, professor lawrence gostin of georgetown university law center led the drafting of the model state emergency health powers act (msehpa).59 the msehpa combined provisions from some noteworthy state statutes and supplemented them with measures to address modern emergencies, including bioterrorism. the states responded positively to the msehpa. by 2006, a total of 171 bills or resolutions were introduced into forty-four states and the district of columbia that included provisions based on the msehpa.60 of these bills, sixty-six were enacted in thirty-eight states and the district of columbia.61 because the msehpa was based on provisions of existing state laws it is difficult to say precisely how many provisions were adopted from the msehpa. only louisiana and south carolina made wholesale adoptions of provisions from the model act.62 59 model state emergency health powers act (2001), available at http://www.publichealthlaw.net/resources/modellaws.htm#msehpa, archived at http://perma.cc/22bg-weep/ (last visited feb. 8, 2014). 60 the model state emergency health powers act (msehpa) state legislative activity, ctr. for law & pub. health at georgetown & johns hopkins univs. http://www.publichealthlaw.net/ msehpa/msehpa%20leg%20activity.pdf, archived at http://perma.cc/rqp3-rdc8. 61 id. 62 the model state emergency health powers act summary matrix, the network for pub. health law, https://www.networkforphl.org/_asset/80p3y7/western-region2015 from sars to ebola 241 sections 604 and 605 of the msehpa deal with isolation and quarantine. among other provisions, the msehpa provides that isolation and quarantine “must be by the least restrictive means,”63 for the minimum time necessary,64 and provide “adequate food, clothing, shelter, means of communication with those in isolation or quarantine and outside of those settings, medication, and competent medical care.”65 procedures for isolation and quarantine put an emphasis on responding to public health emergencies quickly. for example, the msehpa permits the isolation and quarantine of individuals without notice for up to ten days pursuant to an administrative directive,66 as well as a court order. 67 notice of a judicial petition for an isolation or quarantine order must be given to affected individuals or groups within twenty-four hours,68 and hearings based on such a petition must be held within five days.69 the judicial procedures of the msehpa demonstrate why voluntary quarantine is much better than an administrative or courtordered quarantine. among the drawbacks to mandatory quarantine are the need for public health departments to devote essential resources to litigation in a time of emergency, the lack of familiarity of trial court judges with the scientific issues in a quarantine petition, the reluctance of many court personnel to attend a hearing involving deadly and communicable pathogens and the lack of procedures or technology for ex parte hearings, the inability of many court systems to process timely appeals, and the nagging issue of how to deal with individuals who fail to comply with a court-ordered quarantine.70 msehpa-states-table-8-10-12.pdf, archived at http://perma.cc/e8yz9vqe/ (last updated june 2012). 63 the model state emergency health powers act § 604(b)(1) (2001). 64 id. § 604(b)(4). 65 id. § 604(b)(6). 66 id. § 605(a). 67 id. § 605(b). 68 id. § 605(b)(3). 69 id. § 605(b)(4). 70 see infra notes 181-183 and accompanying text. 242 indiana health law review vol. 12:1 although the msehpa was designed to provide clearer standards and stronger guarantees of due process, it has been criticized for failing to provide adequate protection for civil liberties and dispensing with the legal rights of some individuals.71 for example, the msehpa grants states the authority to isolate individuals who refuse vaccination during a public health emergency.72 in addition, under the msehpa out-of-state emergency health care providers are immune from liability for damages caused by negligent treatment “unless such damages result from providing or failing to provide, medical care or treatment under circumstances demonstrating a reckless disregard for the consequences so as to affect the life or health of the patient.”73 nevertheless, there have not been any medical malpractice cases arising from volunteer treatment in a public health emergency, and there is little evidence that malpractice immunity is necessary to attract volunteer health care providers.74 finally, the msehpa provides for the courts to use the preponderance of the evidence standard.75 71 george j. annas, blinded by bioterrorism: public health and liberty in the 21st century, 13 health matrix 33, 45–54 (2003); george j. annas, bioterrorism, public health, and civil liberties, 346 new eng. j. med. 1337, 1338-39 (2002); wendy e. parmet, quarantine redux: bioterrorism, aids, and the curtailment of individual liberty in the name of public health, 13 health matrix 85, 86–87 (2003). see also lawrence o. gostin, the model state emergency health powers act: public health and civil liberties in a time of terrorism, 13 health matrix 3, 5 (2003) (“despite its success in many states, the model act has become a lightning rod for criticism from both ends of the political spectrum.”). 72 the model state emergency health powers act § 603(a)(3) (2001). 73 id. § 608(b)(3). 74 see mark a. rothstein, malpractice immunity for volunteer physicians in public health emergencies – adding insult to injury, 38 j.l. med. & ethics 149 (2010) (asserting that dividing patients into paying customers who retain all of their legal rights and indigent customers who lose certain legal rights is unnecessary and further stigmatizes a vulnerable group at a time when social solidarity is of utmost importance to public health). 75 the model state emergency health powers act § 605(e) (2001). notably, the turning point model state public health act http://dx.doi.org/10.1056/nejm200204253461722 http://dx.doi.org/10.1111%2fj.1748-720x.2010.00475.x 2015 from sars to ebola 243 another model law project, this one supported by the robert wood johnson foundation, the turning point model state public health act (tpmspha),76 addressed an even broader array of public health issues, not just those arising in emergencies. article v of the tpmspha dealing with authorities/powers is where the quarantine and isolation provisions appear. the following eight conditions and principles apply to isolation and quarantine: (1) isolation and quarantine must use the least restrictive means necessary; (2) isolated individuals must be kept separately from quarantined individuals; (3) the health status of individuals in isolation and quarantine must be monitored regularly; (4) an individual in quarantine who becomes infected must be removed promptly to isolation; (5) isolation and quarantine must be terminated immediately when an individual no longer poses a substantial risk of transmitting an infection; (6) individuals must be supplied with adequate food, clothing, shelter, a means of communication, and competent medical care; (7) outside premises used for isolation and quarantine must be maintained in a safe and hygienic manner; and (8) to the extent possible, cultural and religious beliefs shall be respected.77 the tpmspha provides for quarantine and isolation with notice78 and without notice.79 quarantine and isolation without notice is permitted only if notice “would significantly jeopardize the agency's ability to prevent or limit the transmission of a contagious or possibly contagious disease to others.”80 the tpmspha provides for prompt hearings; the government must appoint counsel without section 5-108[e](4) uses the “clear and convincing evidence” standard for quarantine orders. see the turning point model state public health act (2003), available at http://www.publichealthlaw.net/modellaws/mspha.php, archived at http://perma.cc/h2ak-msd2. 76 the turning point model state public health act, supra note 75. 77 id. § 5-108[b]. 78 id. § 5-108[e]. 79 id. § 5-108[d]. 80 id. 244 indiana health law review vol. 12:1 charge to those subject to quarantine.81 elements of the tpmspha have been adopted, at least in part, by over half of the states.82 thus, many states have adopted provisions of both the msehpa and the tpmspha. the federal government, specifically the department of health and human services (hhs) and its designated agency, the cdc, also has limited authority to impose quarantine. this authority, pursuant to section 361(b) of the public health service act (phsa), 83 is restricted to preventing communicable diseases from entering the country or crossing state lines.84 to do so, as of 2015, the cdc has twenty quarantine stations at points of entry and land border crossings, which represents a significant increase from the eight stations in place during the sars outbreak of 2003.85 during the ebola epidemic in 2014, cdc personnel at the airport quarantine stations screened international passengers in attempting to prevent the spread of infection. section 361(d) of the phsa also authorizes the surgeon general to isolate individuals with a communicable disease who attempt to cross-state or national borders.86 the phsa lists the following diseases for possible quarantine: cholera, diphtheria, infectious tuberculosis, plague, smallpox, viral hemorrhagic fever, and yellow fever.87 pursuant to executive orders in 2003 and 2005, the following conditions were added: sars and “influenza viruses that are causing, or have the potential to cause, a 81 id. § 5-108[f]. 82 see gostin, supra note 71, at 5. see also james g. hodge, jr., transforming public health law: the turning point model state public health act, 34 j.l. med. & ethics 77 (2006). 83 public health service act of 1944, pub. l. no. 78-410, § 361(b), 58 stat. 682 (codified as amended at 42 u.s.c. § 264(b) (2012)). see 42 c.f.r. parts 70, 71 (2014). 84 42 u.s.c. § 264(b). 85 inst. of med., quarantine stations at ports of entry: protecting the public’s health (laura b. sivitz et al., eds. 2005), available at http://www.nap.edu/openbook.php?record_id=11435 (last visited feb. 17, 2015). 86 public health service act of 1944, pub. l. no. 78-410, § 361(d), 58 stat. 682 (codified as amended at 42 u.s.c. § 264(d)). 87 42 u.s.c. § 264(b) (2014). http://dx.doi.org/10.1111/j.1748-720x.2006.00010.x 2015 from sars to ebola 245 pandemic.”88 on july 31, 2014, president obama amended the executive orders to clarify their applicability. the new language reads as follows: (b) severe acute respiratory syndromes, which are diseases that are associated with fever and signs and symptoms of pneumonia or other respiratory illness, are capable of being transmitted from person to person, and that either are causing, or have the potential to cause, a pandemic, or, upon infection, are highly likely to cause mortality or serious morbidity if not properly controlled. this subsection does not apply to influenza.89 the cdc has separate quarantine regulations for interstate 90 and foreign 91 quarantine. the regulations authorize the detention, isolation, quarantine, or conditional release of individuals for the purpose of preventing the introduction and spread of the communicable diseases listed in the executive orders. 92 besides this limited quarantine authority, the cdc plays an important role in research, education, laboratory services, funding, data gathering, and other matters affecting emergency preparedness and the control of communicable diseases. the decentralized and fragmented nature of american public health law presents great challenges for coordination among federal, state, and local officials as well as among various agencies and private entities. during the 2014 ebola outbreak, the initial handling of thomas eric duncan 88 exec. order no. 13,295, 68 fed. reg. 17,255 (apr. 4, 2003); exec. order no. 13,375, 70 fed. reg. 17,299 (apr. 1, 2005). 89 exec. order no. 13674, 79 fed. reg. 45,671 (jul. 31, 2014) the reason this clarification may be helpful is that the initial symptoms of ebola are influenza-like respiratory involvement. the classic hemorrhagic fever symptoms occur later. see world health organization, supra note 5. 90 42 c.f.r. pt. 70 (2014). 91 42 c.f.r. pt. 71 (2014). 92 42 c.f.r. § 70.6 (2013). 246 indiana health law review vol. 12:1 by texas health presbyterian hospital in dallas is a case in point. at his initial emergency department visit, mr. duncan disclosed that he had recently arrived from liberia, but the information was not received by the examining physicians, who failed to follow-up about his recent travels. this lack of communication or follow-through permitted the index case of ebola in the united states to be misdiagnosed as sinusitis, and mr. duncan was discharged with only a prescription for antibiotics.93 later, the lack of coordination of hazardous waste removal between local public health officials and federal licensing authorities delayed the removal of soiled clothing, bedding, and linens from the apartment where he was staying and where relatives were later quarantined. 94 the enactment of appropriate legislation is only the first step in an effective public health response to infectious disease outbreaks; the laws must be implemented efficiently to achieve the desired results. b. case law the united states supreme court has explicitly upheld the exercise of broad quarantine powers by the states. in the leading case of compagnie francaise de navigation a vapeur v. louisiana state board of health,95 the louisiana board of health imposed a cordon sanitaire on seven parishes in the state, including orleans parish, because of the presence of an unspecified epidemic.96 in theory, the restriction applied to all individuals attempting to enter or leave any of the seven parishes, but it was alleged in the lawsuit challenging the action that the restriction was adopted and applied only to the 408 italian immigrants on the french ship britannia who were attempting to land in new orleans.97 the supreme court upheld the power of the state to enforce quarantine laws in the absence of a contrary federal law, thereby rejecting claims that the state 93 ana campoy et al., u.s. tries to calm public on ebola, wall st. j., oct. 4-5, 2014, at a1, a6. 94 id. 95 186 u.s. 380 (1902). 96 see id. at 381–82. 97 id. at 382. 2015 from sars to ebola 247 of louisiana lacked the authority to regulate international commerce and that the statute violated international treaties.98 perhaps because the case was brought by the steamship company (seeking to recover the cost of caring for the passengers during the quarantine) and not the passengers, neither the majority nor the dissent addressed possible violations of the equal protection clause of the fourteenth amendment in applying the law only to immigrants on one ship.99 because of the severe limitations on individual liberty resulting from quarantine, even the older cases have focused on whether procedural requirements were followed. for example, in state v. kirby,100 an individual who was in quarantine for smallpox left confinement without the permission of the authorities. in a subsequent criminal prosecution for violating quarantine the iowa supreme court noted that the statute required government officials to provide notice of the quarantine to the individual. because there had been no notice the conviction was reversed. in ex parte culver,101 a habeas corpus petition was filed after the defendant was convicted of a misdemeanor in connection with a quarantine. the defendant's niece was in a quarantined premises for diphtheria, and the crime was removing, in the presence of a police officer, the health department placard stating that the premises was subject to quarantine. in affirming the conviction, the california supreme court emphasized the broad powers granted to state officials under the public health act when it held that: there can be no doubt but that . . . the state board of health has power to order the quarantine of persons who have come in contact with cases and carriers of contagious diseases whenever in the judgment of the said 98 id. at 397. 99 see id. at 381. 100 94 n.w. 254 (iowa 1903). 101 202 p. 661 (cal. 1921). 248 indiana health law review vol. 12:1 board such action shall be deemed necessary to protect and preserve the public health.102 more recent state court decisions also have upheld the authority of public health officials to confine individuals to prevent the transmission of infectious disease as long as certain criteria have been met. for example, in greene v. edwards, 103 an individual with “active communicable tuberculosis” was confined in a state hospital pursuant to a state statute. 104 the west virginia supreme court of appeals stayed the individual's confinement, granted the individual a new hearing regarding his confinement, and held that due process guaranteed the individual a hearing with the following procedures: (1) written notice; (2) right to counsel; (3) right to be present, and to cross-examine, confront, and present witnesses; (4) standard of proof of clear, cogent, and convincing evidence; and (5) right to a transcript for purposes of appeal.105 without the timely appointment of counsel, the greene court decided that not all of the constitutional safeguards had been met, and that a new hearing was required.106 it is not clear to what degree these rights would apply to quarantine at home (as opposed to isolation in a state hospital) and possibly larger-scale, but shorter-term confinement rather than for treatment of tuberculosis. other state court decisions have agreed with the rationale of the greene case and upheld state-imposed isolation of individuals with tuberculosis so long as procedural requirements were followed.107 the wording of the state statute authorizing the confinement is very important. in city of milwaukee v. washington, 108 a homeless woman violated a court order to appear for 102 id. at 663. 103 263 s.e.2d 661 (w. va. 1980). 104 id. at 661–62. 105 id. at 662–63. 106 id. at 663–64. 107 see, e.g., levin v. adalberto, 67 cal. rptr. 3d 277, 286 (cal. ct. app. 2007); city of newark v. j.s., 652 a.2d 265, 278 (n.j. super. ct. law div. 1993). 108 735 n.w.2d 111 (wis. 2007). 2015 from sars to ebola 249 treatment and monitoring of her tuberculosis.109 when she was located and sent to a correctional facility for her period of isolation, she objected and said she should be sent to a hospital, instead. 110 the wisconsin supreme court interpreted the relevant state statute providing for use of the “least restrictive” alternative to quarantine or isolation to mean that confinement had to be the least restrictive method of social distancing, not that the confinement had to be in the least restrictive facility. 111 by contrast, in souvannarath v. hadden,112 the court did not allow for the imprisonment of a tuberculosis patient because the applicable california statute expressly provided that individuals quarantined or isolated for tuberculosis “shall not” be placed in a correctional facility.113 v. an ethics framework the ethical basis of public health is utilitarianism.114 efforts to prevent catastrophic diseases and alleviate mass suffering provide a broad justification for infringing on the rights of some members of the public through quarantine, property seizure, vaccination mandates, or other public health measures. utilitarian concerns about maximizing benefits, however, are not a blank check for public health interventions. in the united states, with its strong libertarian tradition and its commitment to autonomy, justice, and procedural due process, the exercise of public health authority always must be preceded by a showing of necessity, minimal infringement on individual rights, and essential procedural due process. in resolving the invariable conflict between utilitarianism and libertarianism, professor james childress and colleagues have suggested there are five 109 id. at 114. 110 id. 111 see id. at 128–29. 112 116 cal. rptr. 2d 7 (cal. ct. app. 2002). 113 id. at 13. 114 antoon hubert & marie kerkhoff, origin of modern public health and preventive medicine, in ethical dilemmas in health promotion (spyros doxiadis, ed. 1987). 250 indiana health law review vol. 12:1 “justificatory conditions” that help determine “whether promoting public health warrants overriding such values as individual liberty or justice in particular cases.” 115 according to this general formulation, the justificatory conditions are effectiveness, proportionality, necessity, least infringement, and public justification.116 although quarantine may be viewed as the paradigmatic case for balancing individual and communal interests, quarantine also can be regarded as sui generis because of the extreme limits it places on liberty. therefore, quarantine requires its own analytical framework. adapting from the typology of childress et al., the following four ethical considerations discussed below should be evaluated in deciding whether to order a quarantine and, if so, the specifics of quarantine. the ethical considerations are: (1) necessity, effectiveness, and scientific rationale; (2) proportionality and least infringement; (3) humane supportive services; and (4) public justification.117 a. necessity, effectiveness, and scientific rationale “necessity” means public health officials ought to impose quarantine only in the face of a demonstrable threat to public health.118 the use of quarantine is based on the assumption that asymptomatic individuals exposed to an infection are capable of transmitting the infection to others, perhaps as efficiently as symptomatic individuals. in addition to individual quarantine, area-wide quarantine may be an effective way of limiting the spread of the 115 james f. childress et al., public health ethics: mapping the terrain, 30 j.l. med. & ethics 170, 172 (2002). see also nancy e. kass, an ethics framework for public health, 91 am. j. pub. health 1776 (2001). 116 id. 117 there are several other formulations of principles for quarantine. many of them have similar emphasis. see, e.g., ross e.g. upshur, principles for the justification of public health intervention, 93 can. j. pub. health 101, 102–03 (2002) (proposing the following principles: (1) necessity, (2) least restrictive means, (3) necessary support services, and (4) communication of reasons). 118 gostin & berkman, supra note 47, at 147. http://dx.doi.org/10.1111/j.1748-720x.2002.tb00384.x http://dx.doi.org/10.2105/ajph.91.11.1776 2015 from sars to ebola 251 disease. the potential effectiveness of quarantine is related to the interval between exposure and the onset of illness. for infections with a short interval, such as the one to four days for influenza, there may be a narrower window to impose quarantine.119 for ebola, with a two to twenty-one day incubation period, a longer quarantine has been used; indeed, the long quarantine period has been associated with many problems in liberia and the united states.120 regardless of the specifics, quarantine has been successful in various settings, from decreasing fatality rates in the spanish flu pandemic121 to reducing transmission of a more recent measles outbreak.122 for sars, there was a presumptive ten-day period between exposure and symptoms.123 although halting the spread of sars justified some quarantine, the relatively low rate of transmissibility of the causative coronavirus by asymptomatic individuals lessened the need for and the efficacy of large-scale quarantine.124 as with any public health measure, quarantine should not be invoked unless the best available scientific evidence indicates it is necessary and likely to be effective in controlling the epidemic. 125 unfortunately, it is rarely possible to make precise calculations of necessity and efficacy in advance of imposing quarantine. thus, social distancing measures should be adopted that balance the degree of coercion with the expected benefit.126 in some 119 lawrence o. gostin, public health strategies for pandemic influenza: ethics and the law, 295 jama 1700, 1703 (2006). 120 see part vi infra. 121 markel, supra note 31, at 644. 122 see delaporte, supra note 30. 123 mark a. rothstein et al., quarantine and isolation: lessons learned from sars: a report to the centers for disease control and prevention 23 (2003), available at http://stacks.cdc.gov/view/cdc/11429, archived at http://perma.cc/x4te-f2pb. 124 see steven riley et al., transmission dynamics of the etiological agent of sars in hong kong: impact of public health interventions, 300 science 1961, 1961 (2003). 125 see upshur, supra note 117, at 102-03. 126 ctrs. for disease control & prevention, ethical guidelines in pandemic influenza 8 (2007); a.m. viens et al., your liberty or http://dx.doi.org/10.1001/jama.295.14.1700 http://dx.doi.org/10.1126/science.1086478 252 indiana health law review vol. 12:1 public health emergencies, however, government leaders and public health officials have ordered quarantines that were unnecessary and unjustified by the scientific evidence. for example, during the sars epidemic, india and thailand quarantined all foreign visitors from countries with sars outbreaks, even if they had no symptoms or known exposures.127 similarly, during the ebola epidemic, north korea imposed a three-week quarantine on travelers entering from every country.128 a glaring overuse of individual quarantine occurred in taiwan during the sars epidemic, when 131,132 people were placed under home quarantine, but only twelve were found to have potential cases of sars, and only two had confirmed cases of sars. 129 such unwarranted public health measures can do more than inconvenience the people placed in quarantine. officials in taiwan subsequently concluded that the aggressive use of quarantine contributed to public panic and thus proved counterproductive to public health. 130 this experience should give pause to public health officials before they recommend sweeping quarantine measures without sufficient evidence of necessity and a compelling scientific rationale. during the ebola epidemic, the government of sierra leone imposed an area-wide quarantine in about one-fourth of the country, affecting over one million people. 131 travelers were permitted to travel through quarantine zones only between the hours of 9 a.m. and 5 p.m., and they were warned not to get out of their vehicles while traveling through these areas.132 these restrictions came only a week your life: reciprocity in the use of restrictive measures in the context of contagion, 6 j. bioethical inquiry 207, 208 (2009). 127 rothstein et al., supra note 123, at 128. 128 choe sang-hun, north korea said to impose ebola quarantine on all travelers, n.y. times, oct. 31, 2014, at a23, archived at http://perma.cc/w6df-vtsh. 129 rothstein et al., supra note 123, at 131. 130 id. 131 adam nossiter, ebola epidemic worsening, sierra leone expands quarantine restrictions, n.y. times, sept. 26, 2014, at a16, archived at https://perma.cc/jh9v-fx9x?type=image. 132 id. http://dx.doi.org/10.1007/s11673-009-9149-2 2015 from sars to ebola 253 after a three-day home quarantine of the entire country, in which 30,000 volunteers went house-to-house to educate the public about ebola and remove the dead. 133 president ernest bai koroma acknowledged that the new quarantine would “definitely pose great difficulties for our people,” but he said there was little choice.134 a poorly devised and implemented quarantine may cause great harm. in sierra leone, some villages set up informal “isolation centers,” with citizens quarantining one another, “an incredibly dangerous ad hoc solution being performed without appropriate protection.” 135 meanwhile, the lack of hospital beds, ambulances, and safe burial practices continued to spread infection. 136 according to anthony banbury, head of the united nations mission for ebola emergency response, up to one-half the deaths in sierra leone were caused by unsafe burial practices.137 to be effective, a quarantine must be part of a scientifically compelling, overall strategy for battling the outbreak of infectious disease. for example, in liberia the escalation in ebola cases was largely due to the lack of hospital space, personal protective equipment, and strict infection control procedures in health care facilities. at the height of the epidemic, only eighteen percent of patients were being cared for in hospitals, well below the seventy percent the cdc estimated would be necessary to prevent 133 adam nossiter, lockdown begins in sierra leone to battle ebola, n.y. times, sept. 20, 2014, at a1, archived at http://perma.cc/8bjh-cj7j; rukmini callimachi, fear of ebola drives mob to kill officials, n.y. times, sept. 19, 2014, at a15, archived at http://perma.cc/jc9f-bpus. 134 nossiter, supra note 131. 135 jeffrey gettleman, despite aid push, ebola is raging in sierra leone, n.y. times, nov. 29, 2014, at a1, a14, archived at http://perma.cc/uy46-p9a6. 136 id. 137 doctor who died of ebola hailed as a hero, daily mail (nov. 29, 2014), archived at http://perma.cc/2q2m-8ywy. see also carrie f. nielsen et al., improving burial practices and cemetary management during an ebola virus disease epidemic -sierra leone, 2014, 64 morbidity & mortality weekly rep. 20 (2015). 254 indiana health law review vol. 12:1 cases from increasing.138 because of a lack of functioning hospitals, most ebola patients were cared for at home by relatives and friends who lacked training and infection control materials, thereby spreading the deadly infection to caregivers. the government provided little or no assistance. according to the son of one victim, “the only thing the government can do is come for the bodies. they are killing us.”139 ebola has been an epidemic overwhelmingly affecting caregivers, both health care workers and family members of patients. according to a study of ebola in sierra leone, the incidence of ebola in health care workers was 103-fold higher than that of all other individuals in the country.140 this study further confirms that the necessity, effectiveness, and scientific rationale of any quarantine are closely related to the epidemiology of the disease outbreak. b. proportionality and least infringement “proportionality” means the public health response is appropriate in light of the threat; in other words, there is a reasonable relationship between the burdens and the expected benefits.141 not all events of infectious disease requiring social distancing measures justify using quarantine, the most coercive and intrusive measure. on the other hand, shelter in place or other measures may be insufficiently aggressive. for example, during the early days of the ebola epidemic in west africa, some governments declared stay-at-home days for “reflection, education, and prayers” as a modest and noncoercive social 138 norimitsu onishi, in liberia, home deaths spread circle of contagion, n.y. times, sept. 25, 2014, at a1, a6, archived at http://perma.cc/fgt7-yxa9. 139 id. at a1. another resident of liberia similarly remarked: “no one comes when we are sick, only when we are dead.” aryn baker, racing ebola: what the world needs to do to stop the deadly virus, time, oct. 13, 2014, at 38, 40. 140 peter h. kilmarx et al., ebola virus disease in health care workers – sierra leone, 2014, 63 morbidity & mortality weekly rep. 1168 (2014). 141 gostin & berkman, supra note 47, at 148. 2015 from sars to ebola 255 distancing measure.142 similarly, guinea closed all schools and universities indefinitely. 143 these measures were ineffective because they were not stringent enough and therefore not proportional to the threat. later, when the epidemic worsened, some of the quarantine measures were overly aggressive and counterproductive to public health and humanitarian objectives. public health officials need to strike the right balance in arriving at “proportionality”— and this is not easy to do. when the initial ebola cases spread to the united states, first in dallas and then in new york city, public fears caused twenty-one states to impose a mandatory twenty-one-day quarantine of all health care workers returning to the united states after treating ebola patients in west africa.144 it is very unlikely that these lowto moderate-risk health care workers with “protected exposures” (i.e., they used personal protective equipment and strict infection control measures) needed to be in quarantine instead of self-monitoring. even assuming some type of social distancing was prudent to prevent transmission of ebola, imposing such a long period was not supported by the science. the mean incubation period for 142 gostin et al., supra note 33. 143 tamba jean-matthew, guinea postpones reopening of schools due to ebola, africa rev., sept. 8, 2014, http:www.africareview.com/ news/guinea-postpones-reopening-of-schools-due-to-ebola/979180/2445502/-/wwb4omz/-/index.html. 144 cdc, interim table of state ebola screening and monitoring policies for asymptomatic individuals, http://www.cdc.gov/phlp/docs/interim-ebolascreening.pdf (last visited feb. 8, 2015); see marc santora, first patient quarantined under strict new policy tests negative for ebola, n.y. times, oct. 25, 2014, at a1, archived at http://perma.cc/bw7p-2759 (discussing case of nurse quarantined in n.j.). 256 indiana health law review vol. 12:1 ebola is eight to ten days,145 and very few people become symptomatic after fourteen days.146 one consequence of states imposing twenty-one day quarantines was that essential health care workers were dissuaded from volunteering to serve in west africa. 147 other important reasons for questioning these ad hoc state policies include possibly undermining the cdc's credibility and confusing the public by having different quarantine policies in each state. a universally applied twenty-one-day quarantine for all individuals who travelled to west africa, including members of the armed forces who merely built health care facilities, was neither scientifically indicated nor proportional to the risk. furthermore, such a long quarantine period increases the burdens on public officials to monitor compliance and to provide food, medicine, and other supportive services. during the ebola outbreak, the cdc did not initially recommend quarantine for asymptomatic contacts of ebola patients whose only exposure to an ebola patient occurred before the patient had symptoms and became contagious.148 the first quarantine order in the united states involving ebola took place on october 2, 2014, when texas health officials served a quarantine order on four close family members of the first ebola case, thomas eric duncan. the order required the family members to remain in their small apartment for an additional seventeen days (for a total of 145 ebola (ebola virus disease) – signs and symptoms, cdc, www.cdc.gov/vhf/ebola/symptoms/index.html (last visited feb. 10, 2015); see also who ebola response team, ebola virus disease in west africa – the first 9 months of the epidemic and forward projections, 371 new eng. j. med. 1481, 1487 (2014) (mean incubation period is 11.4 days). 146 who ebola response team supra note 145; see also cdc, interim u.s. guidance for monitoring and movement of persons with potential ebola virus disease exposure (dec. 24, 2014), archived at http://perma.cc/6896-z4kr/ (stating that “risk falls substantially after 2 weeks”). 147 greg botelho, should health care workers who treat ebola in africa be quarantined?, cnn (oct. 26, 2014) http://www.cnn.com/2014/10/24/health/ebola-travel-policy/, archived at http://perma.cc/w9qr-dysr. 148 cdc, supra note 146. http://dx.doi.org/10.1056/nejmoa1411100 2015 from sars to ebola 257 twenty-one days post exposure), and to comply with blood tests and other monitoring deemed necessary by public health officials. 149 subsequently, the cdc revised its recommendations to provide that all asymptomatic health care workers returning from west africa should be regarded as having “some risk” of ebola and therefore required “direct active monitoring” for twenty-one days, with possible additional restrictions on their right to travel freely to be determined on a case-by-case basis by local public health officials.150 to be effective, any public health response to an infectious disease outbreak depends on the prompt clinical diagnosis of infected persons and the prompt imposition of isolation. in a mere two days, the time between when mr. duncan was mistakenly discharged from the hospital's emergency department and the time he was readmitted and placed in isolation, as many as 100 individuals had possible exposure. counting the contacts of the health care workers who treated him, 177 people in texas were placed in quarantine.151 two of the nurses who treated mr. duncan in the final stages of his illness became infected and, after treatment at other institutions, completely recovered.152 in addition to those quarantined in texas, 164 contacts of one of the nurses who travelled to akron, ohio, were asked to monitor their temperature and symptoms for the twenty-one-day incubation period. of those, twenty contacts who were within a three-foot radius of the patient and in the same enclosed space for more than an hour were 149 amy e. nutt, family of texas ebola patient ordered to stay home, comply with blood tests, wash. post, oct. 2, 2014, archived at http://perma.cc/qn9d-r8lm. 150 see cdc, supra note 146, at 5-6. 151 michelle s. chevalier, ebola virus disease cluster in the united states – dallas county, texas 2014, 63 morbidity & mortality weekly rep. 1087 (2014); manny fernandez, dallas closes the door on its ebola scare, n.y. times, nov. 8, 2014, at a10, archived at http://perma.cc/94dn-5znk. 152 alan blinder, amber joy vinson, dallas nurse treated for ebola, is released from hospital, n.y. times (oct. 28, 2014), available at http://www.nytimes.com/2014/10/29/us/ebola-outbreak-dallas-nurseamber-joy-vinson.html?_r=0, archived at http://perma.cc/23r4-fh77. 258 indiana health law review vol. 12:1 actively monitored through twice daily temperature checks (once in person and once by phone), and three individuals with likely skin-to-skin contact with the patient were placed in quarantine.153 such measures, clearly intended to allay public fears, had the opposite effect and undoubtedly contributed to panic. the entire, unfortunate episode at texas health presbyterian hospital in dallas, where mr. duncan was treated, could and should have been prevented. it was unrealistic for the cdc to expect that every hospital would be able to treat ebola patients without endangering the medical and nursing staff.154 eventually, the cdc changed its policy and certified thirty-five hospitals nationwide as being prepared to treat ebola patients, and most of these hospitals are located within a short distance of the airports where passengers land who originated in west africa and connected in europe.155 at the numerous public health briefings about ebola public health officials mentioned that the illness can be spread only when there is direct contact with the bodily fluids of an infected individual. this statement is true, but imprecise and incomplete. first, although a wide range of bodily fluids may have detectable levels of virus within days after infection, without more, the statement gives the 153 carolyn l. mccarty et al., response to importation of a case of ebola virus disease – ohio, october 2014, 63 morbidity & mortality weekly rep. 1089 (2014). 154 press release, cdc, cdc's surge response to west african ebola outbreak (aug. 6, 2014), available at http://www.cdc.gov/media/releases/2014/p0806-ebola.html, archived at http://perma.cc/f93d-y6n4. nevertheless, a survey by the association for professionals in infection control and epidemiology indicated that only 6% of over 1000 infection control specialists surveyed october 1015, 2014, said that their hospitals were “well-prepared” to receive a patient with ebola. apic ebola readiness poll, association for professionals in infection control and epidemiology (oct. 2014), http://www.apic.org/resource_/tinymcefilemanager/topicspecific/ebola_readiness_poll_results_final.pdf. 155 u.s. names 35 ebola-certified hospitals, nbc news (dec. 2, 2014) http://www.nbcnews.com/storyline/ebola-virus-outbreak/u-snames-35-ebola-certified-hospitals-n259896, archived at http://perma.cc/sef8-q5x6. 2015 from sars to ebola 259 impression that ebola can be spread by having direct contact with any bodily fluid. in fact, contact must be with the highly infectious bodily fluid (i.e., vomit, diarrhea, or blood) of a seriously ill patient. second, the statement fails to mention that there is no evidence of anyone becoming infected with ebola in this epidemic without direct contact with the bodily fluid of an individual whose condition has progressed at least to the gastrointestinal phase of the illness. this phase occurs between three and ten days after the onset of symptoms.156 it should be remembered that the theory behind imposing quarantine is that some asymptomatic individuals may be infectious, and without quarantine they may expose others to the disease. this logic applies well with regard to many of the airborne diseases, such an influenza and sars. it is not the case with ebola, because an asymptomatic individual is not infectious and neither is a patient in the earliest stage of infection when the most noteworthy symptom is the onset of fever. individuals become infectious only when the viral load in their bodily fluids is extremely high, 157 which occurs when the individuals become seriously ill and they release significant amounts of vomit, diarrhea, and blood.158 “we have very strong reason to believe that transmission occurs when the viral load in bodily fluids is high, on the order of millions of virions per microliter.” 159 of crucial importance, fever precedes the infectious stage; it does not indicate the infectious stage.160 156 see daniel s. chertow et al., ebola virus disease in west africa – clinical manifestations and management, 371 new eng. j. med. 2054, 2054 (2014) (reporting that of more than 700 patients treated in liberia “none that we were aware of had contracted disease from an infected contact during the early febrile [0-3 days from onset of symptoms] phase of illness” when the primary symptom is fever). see also donald g. mcneil, jr., fewer ebola cases go unreported than thought, study finds, n.y. times, dec. 16, 2014, at a8, archived at http://perma.cc/l8mb-u4lk (reporting on study that transmission of ebola occurs mostly within families, in hospitals, and at funerals). 157 jeffrey m. drazen et al., ebola and quarantine, 371 new eng. j. med. 2029 (2014). 158 id. see chertow et al., supra note 156. 159 drazen, supra note 157, at 2029. 160 id. http://dx.doi.org/10.1056/nejmp1413084 http://dx.doi.org/10.1056/nejme1413139 260 indiana health law review vol. 12:1 therefore, all individuals with possible ebola exposure, but especially knowledgeable health care workers, who have any initial symptoms of ebola infection, including fever, malaise, fatigue, and body aches, can be expected to seek hospital-based treatment immediately upon onset of any symptoms. even at this stage they are not infectious. individuals who seek treatment promptly can be safely isolated, and they stand the best chance of recovery. in the united states, other than two nurses who treated mr. duncan in dallas, not a single contact of an ebola patient became infected, including mr. duncan's relatives who lived with him in a small apartment after he displayed symptoms of disease. notwithstanding any realistic risk of contagion from asymptomatic health care workers, some health care workers with possible ebola exposure failed to limit their public contact during the twenty-one day period after their last known exposure. this conduct contributed to substantial public anxiety in the united states. although there was no risk of transmission while they were asymptomatic or until days later if they became symptomatic, these brave and selfless health care workers still had an obligation to help prevent the spread of panic. the situation could have been easily averted through selfimposed social distancing and by simply maintaining a more private lifestyle until the end of the incubation period. it is an interesting question of when scientifically unnecessary measures are appropriate to quell irrational public fears or when doing so “out of an abundance of caution” makes matters worse. in retrospect, a modest level of self-restraint would likely have preempted the irrational overreactions by some state and local governments. perhaps in response to some highly publicized incidents of public contacts by possibly exposed health care workers, as well as to preempt additional actions at the state level, the cdc revised its guidance for monitoring of persons with ebola exposure to permit more individualized assessments of risk and more active surveillance of individuals with various degrees of risk. 161 the cdc's revision of its 161 cdc, supra note 146. 2015 from sars to ebola 261 guidance, however, by following more aggressive state policies, may have increased doubts about the adequacy of cdc's initial recommendations, thereby seeming to confirm the wisdom of the expanded quarantine measures imposed by some state governments.162 deciding whether quarantine is necessary and, if so, determining the appropriate length of quarantine, are only the first steps in tailoring quarantine to the specific public health conditions. additional considerations include the type of quarantine (individual or area-wide), whether quarantine should be voluntary or mandatory, how many individuals should be quarantined, the criteria for inclusion or exclusion, and the appropriate locations for quarantine. the overall goal should be to adopt the least burdensome means necessary to accomplish the desired public health objective. using narrowly tailored public health measures also leads to greater public support for the entire range of public health interventions needed in an epidemic.163 quarantine planning should focus on the totality of effects on individuals and society, not merely on the projected effects on infection rates.164 there is an important social element to the means chosen to implement quarantine. for example, in china, during the sars outbreak, the level of compliance with orders directing individuals into quarantine at government facilities was lower than for quarantine at home because many people did not want to abandon their pets.165 thus, proportionality, minimal infringement on liberty, and consideration of the lifestyles of the individuals being placed in quarantine are crucial to promote compliance and public health. in the united states, a commitment to proportionality increasingly has been reflected in public health 162 see lisa rosenbaum, communicating uncertainty – ebola, public health, and the scientific process, 372 new eng. j. med. 7 (2015) (observing that ambiguous messages increase public panic). 163 see sam berger & jonathan d. moreno, public trust, public health, and public safety: a progressive response to bioterrorism, 4 harv. l. & pol'y rev. 295, 316–17 (2010). 164 see wendy e. parmet, j.s. mill and the american law of quarantine, 1 pub. health ethics 210, 210 (2008). 165 rothstein et al., supra note 123, at 25. http://dx.doi.org/10.1056/nejmp1413816 http://dx.doi.org/10.1093/phe/phn029 262 indiana health law review vol. 12:1 preparedness documents, especially those dealing with influenza pandemics. for example, in 2007, the cdc proposed the pandemic severity index (psi), a classification scale for influenza pandemics. 166 based on the saffirsimpson hurricane scale, the psi contains five categories, ranging from 1 to 5, which increase based on the severity of the case-fatality ratio (cfr).167 a category 1 event, such as seasonal influenza, has a cfr of less than 0.1%.168 on the other extreme, a category 5 event, such as the 1918-1919 spanish flu pandemic, has a cfr of 2.0% or higher. 169 along with the new classification scale, the cdc also recommended the following four primary measures for slowing a pandemic: (1) isolation and treatment of people who have suspected or confirmed cases of pandemic influenza; (2) voluntary home quarantine of household contacts of those with suspected or confirmed pandemic influenza; (3) dismissing school classes and closing daycare centers; and (4) changing work schedules and canceling large public gatherings.170 by linking the intrusiveness of the response to the severity of the disease outbreak the psi attempts to implement proportionality in the use of nonpharmaceutical disease-control measures.171 a similar commitment to proportionality is reflected in other public health laws and recommendations. for example, the model state emergency health powers act requires that quarantine or isolation be imposed only if it is the “least restrictive alternative” available to control a public health emergency.172 as evidenced during the ebola 166 dep’t of health and human servs., interim pre-pandemic planning guidance: community strategy for pandemic influenza mitigation in the united states—early, targeted, layered use of nonpharmaceutical interventions 31 (2007), available at http://www.cdc.gov/nonpharmaceutical-interventions/guidance, archived at http://perma.cc/9j3x-vaxf. 167 see id. at 31–32. 168 id. at 32. 169 id. 170 id. at 35. 171 see id. 172 the model state emergency health powers act § 604(b). 2015 from sars to ebola 263 outbreak, however, public and political pressures can lead to revision of previously adopted guidelines and policies. c. humane supportive services quarantine requires substantial logistical support, although the amount of support depends on the size and scope of the quarantine as well as the resources in place at the start of the quarantine. in quarantine at home, food, medicine, and other supplies and services must be provided to people who are unable to leave their homes. public health officials need to be able to monitor the individuals in quarantine, a communication system must be established to connect the individuals in quarantine with health care providers, and a transportation plan is needed to take individuals who become ill to a hospital or other health care facility as soon as possible. in addition, clothing, bedding, and other personal items used by a patient placed in isolation may need to be removed and safely disposed of to prevent the infection of others, including individuals placed in quarantine at the same location.173 in monitoring the health status of the individuals in quarantine, public health officials need to strike a balance between public health and individual liberty. for example, in singapore, during the sars epidemic, all people quarantined at home were required to have a web camera connected at all times and to respond to random checks by the government to verify their presence at home.174 they also were required to check and record their temperatures twice a day, on camera if so directed.175 it is unlikely that such prescriptive and intrusive measures would be as well tolerated in the united states as they were in singapore.176 similarly, in the poor west african countries affected by 173 see greg botelho & michael martinez, frustrated woman quarantined with sheets, towels soiled by ebola patient, cnn.com, oct. 2, 2014, archived at http://perma.cc/avr5-w4ev. 174 rothstein et al., supra note 123, at 89. 175 id. 176 see id. at 131. 264 indiana health law review vol. 12:1 ebola, the use of a web camera is, obviously, out of the question. providing humane supportive services to individuals in quarantine is labor-intensive, but the available supply of service providers may be curtailed by illness, death, quarantine, or refusal to report to work. 177 providing humane supportive services is also more complicated in a pluralistic and heterogeneous society, such as the united states, than in more homogeneous asian countries, such as those affected by sars. 178 among the vulnerable populations that might be affected to a greater extent by quarantine are individuals with disabilities, elderly persons, pregnant women, children, prisoners, economically disadvantaged minorities, people with mental illness or mental retardation, and individuals with language barriers.179 even beyond these groups, a broad quarantine is likely to involve large numbers of individuals with diverse lifestyles. for example, dietary restrictions based on religion, culture, and health conditions 180 mean that a standard food package for home delivery will not be sufficient for diverse individuals in quarantine. nongovernmental organizations, such as the red cross, and governmental social service agencies need to coordinate their efforts and consider the special needs of people in quarantine.181 other populations in quarantine raise additional logistical and policy challenges. if a home-based quarantine is adopted, alternate facilities will be needed for people without homes in the quarantine area, such as students, visitors, transients, and homeless people. government officials will need to decide whether to ignore the lawbreaking status of undocumented aliens, criminal fugitives, and other individuals to encourage them to enter 177 see mcneil, supra note 35. 178 see rothstein et al., supra note 123, at 26. 179 sharona hoffman, preparing for disaster: protecting the most vulnerable in emergencies, 42 u.c. davis l. rev. 1491, 1499 (2009). 180 see generally dennis p. andrulis et al., preparing racially and ethnically diverse communities for public health emergencies, 26 health affairs 1269, 1269 (2007). 181 rothstein et al., supra note 123, at 138. http://dx.doi.org/10.1377/hlthaff.26.5.1269 2015 from sars to ebola 265 quarantine rather than possibly spread disease. immunity from arrest and prosecution were among the measures adopted by singapore during the sars outbreak.182 the quarantine of individuals addicted to illicit drugs poses another policy challenge. a simple admonition by public health officials or even a judicial order to stay at home is unlikely to be obeyed by individuals with a drug addiction, 183 and home delivery of illicit drugs by the government is unlikely to take place for numerous political and logistical reasons. it would be lawful for police to arrest and jail suspected drug addicts for the duration of the quarantine period, but only after they violated a quarantine order. the question of what measures are appropriate for the government to take when there is noncompliance with mandatory quarantine applies to all individuals. once again, it is a matter of proportionality. in particular, guidelines need to be developed for law enforcement personnel who observe individuals violating quarantine. the options for police are to ignore, warn, fine, or arrest and re-quarantine lawbreakers. during the sars epidemic, many police officers that lacked training in infection control and personal protective equipment were reluctant to have close contact with individuals who violated quarantine because they were concerned about their own health. in singapore, anyone violating quarantine had an electric tag put on their leg so they could be monitored.184 during the early days of the ebola epidemic police initially failed to enforce quarantine provisions.185 more aggressive enforcement of the area-wide quarantine in the seaside slum of west point, in liberia's capital of monrovia, led to a violent response.186 in dallas, police were stationed outside the apartment where relatives of thomas eric duncan were quarantined to ensure that they did not 182 id. at 137. 183 id. 184 see rothstein, supra note 123, at 25. 185 see nossiter, supra note 34. 186 see notes 222-248 infra and accompanying text. 266 indiana health law review vol. 12:1 leave.187 similarly, kaci wilcox, an asymptomatic nurse returning from west africa who was placed in quarantine after a single elevated temperature reading, was under constant surveillance by state police when she left her home.188 the financial effect on individuals in quarantine is also an important concern. during the sars epidemic all of the affected countries realized that they needed to enact legislation prohibiting discrimination in employment against individuals in quarantine (and guaranteeing their reemployment) and to supply quarantined individuals with some form of income replacement. without such protections many low-income and self-employed persons who were asymptomatic would feel compelled to violate quarantine and go to work. unfortunately, few, if any, comparable legal protections currently exist in the united states,189 and it is questionable how rapidly such legislation could or would be enacted at either the federal or state level. 190 providing humane supportive services is a government’s moral obligation in a public health emergency. individuals relinquish a degree of liberty in exchange for the government’s actions to preserve public health. the provision of humane supportive services in a public health 187 kevin sack & manny fernandez, delay in dallas ebola cleanup as workers balk at task, n.y. times, oct. 2, 2014, at a1, a14, archived at http://perma.cc/hhq8-kggr. 188 robert gatter, can states force people into quarantine?, here & now—wbur, (oct. 30, 2014) available at http://hereandnow.wbur.org/2014/10/30/hickox-maine-quarantine. 189 mark a. rothstein & meghan k. talbott, job security and income replacement for individuals in quarantine: the need for legislation, 10 j. health care l. & pol’y 239, 243–44 (2007); accord mark a. rothstein & meghan k. talbott, encouraging compliance with quarantine: a proposal to provide job security and income replacement, 97 am. j. public health s49, s49–s52 (2007). see also mark a. rothstein, ebola, quarantine, and the law, 45 hastings ctr. rep. no. 1, at 5 (2015). 190 new york city, however, announced that it was offering job protection and financial guarantees to health care workers traveling to west africa to treat ebola patients. marc santora & anemona hartocollis, in new york, protections offered for medical workers joining ebola fight, n.y. times, oct. 31, 2014, at a23, archived at http://perma.cc/pc6d-q5tw. http://dx.doi.org/10.2105/ajph.2006.097303 2015 from sars to ebola 267 emergency furthers the ethical principles of beneficence, justice, respect for persons, and social solidarity. furthermore, providing humane supportive services also reaffirms the importance of dignity and human rights during times of peril, thereby helping to preserve the social fabric of society that will emerge after the outbreak is contained. internationally, the siracusa principles provide that when a state acts in an emergency it must still respect human dignity and freedom, such as by not acting arbitrarily or discriminatorily and using the least restrictive means. 191 similarly, the world health organization’s (who) global alert and response guiding principles for international outbreak alert and response includes the following: “all network responses will proceed with full respect for ethical standards, human rights, national and local laws, cultural sensitivities and traditions.”192 d. public justification the public’s willingness to comply with public health interventions to combat infectious disease outbreaks lessens the need for governmentally ordered coercive measures and enforcement actions directed at individuals who are noncompliant. among other things, public support requires the government to act with transparency, due process, and fairness. 193 the decision-making process used by public health officials and government leaders should be open, at least to the extent that the rationale for official action is clearly explained to the public. decision makers should marshal the best available scientific evidence and expert opinion on the need for quarantine and then disclose the 191 u.n. econ. & soc. council, status of the international covenants on human rights, u.n. doc. e/cn.4/1985/4 (sept. 28, 1984). 192 world health organization, global alert and response, guiding principles for international outbreak alert and response, www.who.int/csr/outbreaknetwork/guidingprinciples/en/, archived at http://perma.cc/99hv-4r79. 193 margaret p. battin et al., the patient as victim and vector: ethics and infectious disease 385-401 (2009); gostin & berkman, supra note 47, at 170-72. 268 indiana health law review vol. 12:1 information in a timely and understandable manner. 194 good communication with the public may improve voluntary compliance and obviate the need for enforcement.195 in the united states, perhaps the most challenging aspect of public justification would involve convincing individuals to ignore their self-interest in personal liberty to help promote the common good.196 quarantine demands self-sacrifice to benefit society, but america’s public ethos of libertarianism has translated into a historical and pervasive distrust of government, with a strong preference for selfreliance and independence.197 americans are more likely to view health problems as individual rather than community challenges. 198 furthermore, some americans can be expected to resist any government-mandated confinement if they fail to apprehend a direct benefit to themselves or they believe the burden of complying with quarantine would be too great. 199 this would force public health officials to obtain court orders to enforce the public health edicts. although legal challenges of government actions can be viewed as the price for living in a free society governed by the rule of law, excessive litigation during a public health emergency may not be the optimum use of government, including public health, resources. in contrast with the united states, the jurisdictions most affected by sars in asia (china, hong kong, singapore, taiwan, and vietnam), as well as canada, are known for more communitarian values. yet, the responses of individuals in these countries varied during the sars 194 yu wang, the h7n9 influenza virus in china—changes since sars, 368 n. eng. j. med. 2348, 2348 (2013). 195 maxwell j. smith et al., restrictive measures in an influenza pandemic: a qualitative study of public perspectives, can. j. pub. health at e348, e350-51 (july 18, 2012). 196 matthew k. wynia, ethics and public health emergencies: restrictions on liberty, am. j. bioethics 1, 3 (feb. 2007). 197 mark a. rothstein, are traditional public health strategies consistent with contemporary american values?, 77 temp. l. rev. 175, 177 (2004). 198 see id. at 190. 199 see id. at 191. http://dx.doi.org/10.1056/nejmp1305311 http://dx.doi.org/10.1080/15265160701193559 2015 from sars to ebola 269 epidemic. in toronto, there were about 30,000 people in quarantine, and in only twenty-seven cases was a quarantine order required.200 in china, however, despite generally high rates of compliance with various public health measures, tens of thousands of individuals fled from areas when they learned of an impending area-wide quarantine, thereby possibly spreading the epidemic.201 a post-sars survey of residents of hong kong, singapore, taiwan, and the united states indicated substantial concerns about compulsory quarantine, including becoming infected in group quarantine, losing income, and being unable to communicate with family members.202 because rates of noncompliance with quarantine for pandemic influenza or another highly communicable disease could be significant,203 clear public justification and logistical support for individuals in quarantine are essential.204 justice is a primary ethical consideration in quarantine. 205 the burdens and benefits of any public health intervention, especially quarantine, should be equitable in design, application, and effect.206 regrettably, there is a long history in the united states of discriminatory imposition of quarantine, often based on xenophobia and racism. for example, in 1892, after four cases of typhoid fever were discovered in a new york city tenement house among recent russian jewish immigrants who arrived on the ship massilia, city health officials ordered the quarantine of 1200 largely unexposed people who happened to live near the infected passengers. 207 200 rothstein et al., supra note 123, at 58. 201 id. 202 robert j. blendon et al., attitudes toward the use of quarantine in a public health emergency in four countries, 25 health affairs w15, w15–w25 (2006). 203 jason w. sapsin et al., sars and international legal preparedness, 77 temp. l. rev. 155, 164 (2004). 204 id. at 165. 205 see generally daniel markovits, quarantines and distributive justice, 33 j.l. med. & ethics 323 (2005). 206 council on ethical & judicial affairs, the use of quarantine and isolation as public health interventions, 123 pub. health rep. 3 (2008). 207 markel, supra note 8, at 16. http://dx.doi.org/10.1377/hlthaff.25.w15 http://dx.doi.org/10.1111/j.1748-720x.2005.tb00497.x 270 indiana health law review vol. 12:1 similarly, in 1900, to combat the spread of bubonic plague, san francisco enacted an ordinance requiring all chinese residents to receive plague vaccines, and those failing to do so were prohibited from leaving the city.208 because the law expressly applied only to chinese residents, it was declared unconstitutional as violating the equal protection clause of the fourteenth amendment.209 although these infamous incidents are over 100 years old, discrimination in the application of public health policies has taken place in recent times as well. during the sars epidemic there were widespread reports of discrimination against asians in several american cities. in one incident, in vineland, new jersey, a dance troupe from chinatown in new york city was turned away from its annual performances at two middle schools because of fear of sars. one school even sprayed the hallways with the disinfectant lysol® after the troupe left. 210 an unmistakable lesson learned from the aftermath of hurricane katrina in 2005 is that a public health emergency often adversely affects socially and economically vulnerable individuals, and it has the potential to exacerbate existing social inequalities.211 similar disparities existed in the response to the 2009 h1n1 influenza epidemic.212 because the outbreak arose in mexico and spread to the united states, there was substantial mistreatment of and discrimination against latinos, including bullying, stigmatization by health care providers, shops telling mexicans to keep out, and a school denying admission to children uninfected with h1n1, 208 wong wai v. williamson, 103 f. 1, 2-3 (c.c.n.d. cal. 1900); jew ho v. williamson, 103 f. 10, 11-12 (c.c.n.d. cal. 1900). 209 wong wai, 103 f. at 6; jew ho, 103 f. at 23-24. 210 rothstein et al., supra note 123, at 140. 211 see madison powers & ruth faden, social justice: the moral foundations of public health and health policy 3 (2006); lori uscher-pines et al., planning for an influenza pandemic: social justice and disadvantaged groups, 37 hastings ctr. rep. 32, 32 (2007). 212 debra debruin et al., social justice in pandemic preparedness, 102 am. j. pub. health 586, 586 (2012). http://dx.doi.org/10.2105/ajph.2011.300483 2015 from sars to ebola 271 simply because the children had recently emigrated from mexico.213 predictably, during the ebola epidemic, there were many incidents of irrational fear and discrimination. for example, in new jersey, two students from rwanda, which had no ebola cases and is 2800 miles from the affected countries in west africa, were told to stay home.214 similarly, a third grader in connecticut was barred from school because she had attended a family wedding in nigeria, which the who had declared ebola-free.215 in perhaps the most extreme example of irrational fear, a formerly thriving bridal shop in akron, ohio, went out of business because, after it was visited by a presymtomatic, ebola-infected nurse from dallas, it became known as “the ebola store.”216 panic, discrimination, and ostracism have not been limited to the united states. in sierra leone, the fortunate few who survived ebola became literally “untouchable” in many communities.217 in addition, thousands of children who were orphaned by ebola in guinea, liberia, and sierra leone were stigmatized or abandoned by members of their extended family due to irrational fear.218 according to the united nations children's fund (unicef), there may be 10,000 ebola orphans in west africa, many of them languishing in group homes without prospects for 213 monica schoch-spana et al., stigma, health disparities, and the 2009 h1n1 influenza pandemic: how to protect latino farmworkers in future health emergencies, 8 biosecurity & bioterrorism: biodefense strategy, practice, and science 243, 247 (2010). 214 nicholas kristof, how to defeat ebola, n.y. times, oct. 23, 2014, at a35, archived at http://perma.cc/7fds-xzcb. 215 child barred from school; father sues, n.y. times, oct. 29, 2014, at a12, archived at http://perma.cc/w7c4-8l8a. 216 mitch smith, stigma of ebola customer is too much for bridal shop, n.y. times, jan. 9, 2015, at a13, http://perma.cc/9cqx-8xun. 217 adam nossiter, surviving ebola, but untouchable back home, n.y. times, aug. 19, 2014, at a1, http://perma.cc/84m3-blbx. 218 faith karimi, thousands of children orphaned by ebola abandoned, stigmatized, cnn.com, archived at http://perma.cc/m9uq8ef. http://dx.doi.org/10.1089/bsp.2010.0021 272 indiana health law review vol. 12:1 adoption. 219 although there have been some efforts to provide support services 220 and to reintegrate ebola survivors into their communities,221 these efforts have been on a relatively small scale and their effectiveness has not been clearly established. the final aspect of public justification involves the important relations among the government, the media (broadly defined), and the public. the 2009 h1n1 influenza epidemic provides an instructive case study, as it featured the convergence of a new presidential administration in washington, a weak american economy, and a highly skeptical public whose fears and suspicions were stoked by cable news, social media, and a 24/7 news cycle. when the h1n1 influenza strain emerged in 2009, public health officials were quite concerned about a possible 1918-1919type pandemic, inasmuch as the broad h1n1 influenza strain was the same. yet, there were few hard facts or confident predictions available. in attempting to be candid and transparent, however, government admissions of uncertainty seemed to undermine public confidence rather than enhance it. “the result was to heighten public distrust and suspicion of both the government’s credibility and its capacity to provide accurate information.”222 political party affiliation was closely associated not only with trust in the government’s pronouncements, but with the likelihood of taking the h1n1 vaccine. overall, although 80 to 90 million americans received the vaccine, about 70 million doses went unused and had to be destroyed.223 in the future, public health officials should not only make the scientific case for 219 jeffrey gettleman, an ebola orphan's plea: “do you want me?” n.y. times, dec. 14, 2014, at a1, archived at http://perma.cc/c2xwshed. 220 seung hee lee-kwan et al., support services for survivors of ebola virus disease – sierra leone, 2014, 63 morbidity & mortality weekly rep. 1205 (2014). 221 m. allison arwady et al., reintegration of ebola survivors into their communities – firestone district, liberia, 2014, 63 morbidity & mortality weekly rep. 1207 (2014). 222 leslie e. gerwin, the challenge of providing the public with actionable information during a pandemic, 40 j.l. med. & ethics 630, 642 (2012). 223 id. at 648. http://dx.doi.org/10.1111/j.1748-720x.2012.00695.x 2015 from sars to ebola 273 public health action, but they must confront the reality that politicization of public health may undermine public support for any proposed action. 224 vi. ebola quarantine in liberia although various forms of quarantine were used throughout west africa in attempting to control the spread of ebola, the quarantine imposed in liberia is the most troubling and therefore the most instructive. liberia, a country of 4.3 million, had only fifty-one physicians before the ebola epidemic.225 the disease outbreak decimated the existing health care infrastructure and personnel. 226 because most ebola patients were cared for at home by relatives and friends without adequate personal protective equipment, the disease often spread to the caregivers. burial rites, in which family members washed the highly infectious bodies of their loved ones, also caused the spread of infection.227 on august 24, 2014, the government of liberia imposed an area quarantine or cordon sanitaire on the west point section of the capital city, monrovia. 228 west point, a “sprawling slum,” 229 is the home to 60,000 to 120,000 people, who live “crammed into crumbling shacks.”230 the quarantine period of twenty-one days was intended to cover the incubation period for the virus. unsurprisingly, the 224 during the ebola epidemic the public also exhibited a distrust of “experts,” whose motives and reasoning were widely called into question. richard pérez-peña, alarmed by ebola, public isn't calmed by “experts say,” n.y. times, nov. 1, 2014, at a19, archived at http://perma.cc/v7ys-ucub. 225 annette rid & ezekiel j. emanuel, why should high-income countries help combat ebola?, 312 jama 1297 (2014). 226 onishi, supra note 138. 227 nick cumming-bruce, w.h.o. issues new guidelines on safely burying ebola victims, n.y. times, nov. 8, 2014, at a4, archived at http://perma.cc/46un-p4yv. 228 onishi, supra note 37. 229 mcneil, supra note 35. 230 norimitsu onishi, as ebola grips city, quarantine adds to chaos, n.y. times, aug. 29, 2014, at a1, archived at http://perma.cc/8wq2-kmpt. http://dx.doi.org/10.1001/jama.2014.12869 274 indiana health law review vol. 12:1 quarantine proved to be a disaster, and it was ended after ten turbulent days.231 the experience in liberia serves as a case study of the need to apply the four ethical considerations discussed in the previous section of this article. to begin with, it was highly questionable whether the first consideration, “necessity, effectiveness, and scientific rationale,” was even remotely satisfied. liberia's president, ellen johnson sirleaf, who received the nobel peace prize in 2011, 232 reportedly rejected the recommendation of international experts and her own public health officials, and imposed the quarantine at the urging of the army.233 in theory, if the infection could be localized and contained, then it could “burn out” before spreading to the rest of monrovia and beyond. this rationale was unsupported by the conditions of the ebola epidemic, however, as the virus was not localized in west point. furthermore, because people in west point live so close together and formed angry crowds to protest the quarantine, the increase in close human contact actually increased the risk of transmission.234 at the start of the quarantine, dr. martin cetron of the cdc commented that the quarantine “has a lot of potential to go poorly if it's not done with an ethical approach. just letting the disease burn out and considering it [the deaths] the price of controlling it [ebola] – we don't live in that era anymore.”235 231 norimitsu onishi, quarantine for ebola lifted in liberia slum, n.y. times, aug. 30, 2014, at a4, archived at http://perma.cc/smd9rst7. 232 as the first woman leader of an african nation, she was honored for her contributions to freedom and equality, ellen johnson sirleaf – biographical, nobelprize.org, http://www.nobelprize.org/nobel_prizes/peace/laureates/2011/johnson_si rleaf-bio.html, archived at http://perma.cc/znp9-mf6r (last visited feb. 17, 2015). 233 onishi, supra note 231. 234 ebola is spread by contact with infected body fluids, such as blood, vomit, and diarrhea. see world health organization, supra note 5. 235 mcneil, supra note 35. 2015 from sars to ebola 275 according to gregory hartl of the who, during a cordon sanitaire “human rights have to be respected.”236 imposing a cordon sanitaire on such a heavily populated area also fails to satisfy the second consideration of “proportionality and least infringement.” the liberian government failed to use less drastic means of social distancing or other measures to enlist the support of residents in west point or elsewhere in liberia. furthermore, with the twenty-one day period of infectivity, the confinement of such a large population in a small area was almost certain to cause hardship and panic. the lack of “humane supportive services,” the third ethical consideration, doomed the effort from the start. almost immediately after the quarantine was imposed, essential goods, such as food and water, doubled in price.237 one resident remarked at the prospect of the twenty-one day quarantine, “i wouldn't die of ebola but of hunger.”238 many residents worked outside of west point, and they were left with no means of income. there were few health services available for the individuals with malaria and other diseases, and there was little or no medical surveillance to detect new ebola cases and to isolate those individuals. even before the quarantine order, highly infectious dead bodies remained in the streets for hours, sometimes days.239 perhaps the worst mistake of the cordon sanitaire was the lack of “public justification,” the fourth essential ethical consideration. west point was the site of an earlier riot in which residents raided an ebola screening center, accusing the government of bringing sick people from all over monrovia into their neighborhood.240 the lack of public health education was a major contributing factor to spreading the disease from the start of the ebola outbreak, as many individuals did not understand how ebola was 236 id. 237 onishi, supra note 230. 238 onishi, supra note 231. 239 liberian soldiers seal slum to halt ebola, cnn.com, aug. 20, 2014, archived at http://perma.cc/hjg4-qucn. 240 id. 276 indiana health law review vol. 12:1 transmitted and therefore failed to take steps for their own protection. with no public consultation or input from affected citizens, the liberian army suddenly unfurled razor wire to enclose the area. 241 the army and police enforced the restrictions with force. when angry young men hurled rocks and stormed barbed-wire barricades, trying to break out, the police responded by firing live bullets.242 a fifteen year-old boy who was going to buy tea and bread for his aunt was struck by stray bullets and killed. 243 other residents of west point attempted to bribe soldiers to let them out.244 unlike some of the other countries affected by ebola, such as nigeria245 and the democratic republic of congo,246 241 onishi, supra note 231. 242 onishi, supra note 230. 243 id.; norimitsu onishi, inquiry faults liberia force that fired on protesters, n.y. times, nov. 4, 2014, at a4, archived at http://perma.cc/4vl8-azk4. 244 onishi, supra note 230. 245 in contrast to liberia, its wealthier neighbor, nigeria, was able to respond quickly and effectively to its initial ebola cases and limited the death toll to eight. it was critical to stop ebola before it spread, because nigeria is africa's most populous country (177 million, including 21 million in the capital city of lagos). among the resources brought to bear by nigeria were an existing disease operations center, health educators to inform the public, health workers trained in epidemiology to do contact tracing, coordination with nongovernmental entities such as doctors without borders and the international committee for the red cross, isolation rooms at hospitals, air conditioning in hospitals that permitted people wearing personal protective equipment to work longer shifts, laboratories that could perform ebola testing in a matter of hours, and experience in treating lassa fever, cholera, and other infectious diseases. donald g. mcneil, jr., nigeria's actions seem to contain ebola outbreak, n.y. times, oct. 1, 2014, at a1, a12, archived at http://perma.cc/jm6k-x6ev; see also bashir adigun & maria cheng, who: nigeria's ebola outbreak is officially over, newsobserver.com (oct. 20, 2014), http://abcnews.go.com/health/wirestory/nigerias-ebola-outbreakofficially-26316066, archived at http://perma.cc/8pt7-wg95; denise grady, better staffing seen as crucial to close ebola treatment gap, n.y. times, nov. 1, 2014, at a1, archived at http://perma.cc/7qqew7vm; betsy mckay & drew hinshaw, lack of qualified staff in africa hurts effort, wall st. j., oct. 3, 2014, at a6, available at 2015 from sars to ebola 277 liberia lacked the resources to combat the epidemic. in addition to an expanded health care infrastructure, 247 liberia needed public education about ebola; trust building;248 transparency and communication about public health countermeasures; training, personal protective equipment, and hazard pay for health care workers; and precautions against further transmission.249 most of all, it needed more health care workers; if not from africa, then from overseas.250 instead, the most vulnerable citizens in the most vulnerable part of the capital city were trapped by the area quarantine. many residents believed they were confined to die. by contrast, north of monrovia, soldiers http://www.wsj.com/articles/lack-of-qualified-staff-hurts-ebola-fight-inafrica-1412293011, archived at http://perma.cc/f4db-rxmw. 246 the democratic republic of congo (drc), formerly zaire, is the place where the first documented ebola outbreak occurred in 1976. during the most recent ebola epidemic there were sixty-six cases and forty-nine deaths in the drc. after a three-month outbreak, the who has declared the country to be ebola-free. it has been asserted that the relatively mild outbreak in the drc can be attributed to experience dealing with ebola (it was the seventh outbreak in the last 40 years), the remoteness of the country prevented large-scale spread of contagion, and health care workers knew how to diagnose ebola. maggie fox, a tale of two outbreaks: why congo conquered ebola, nbc news (nov. 24, 2014), http://www.nbcnews.com/storyline/ebola-virus-outbreak/taletwo-outbreaks-why-congo-conquered-ebola-n253911, archived at http://perma.cc/47rh-jmq7. 247 andrew s. boozary et al., the ebola outbreak, fragile health systems, and quality as a cure, 312 jama 1859 (2014). 248 according to dr. emmanuel d'harcourt, senior health director for the international rescue committee: “it's trust more than anything that's needed right now. . . . if people don't trust what their governments, the who and aid workers are telling them about how not to spread ebola, it will continue to be spread.” maggie fox, can ebola's deadly rampage in africa be stopped in 2015?, nbc news (dec. 23, 2014), http://www.nbcnews.com/storyline/ebola-virus-outbreak/canebolas-deadly-rampage-africa-be-stopped-2015-n271001, archived at http://perma.cc/qe7a-e5mx. 249 almea matanock et al., ebola virus disease cases among health care workers not working in ebola treatment units – liberia, june-august, 2014 , 63 morbidity & mortality weekly rep. 1077 (2014). 250 grady, supra note 245; betsy mckay & drew hinshaw, lack of qualified staff in africa hurts effort, wall st. j., oct. 3, 2014, at a6, archived at http://perma.cc/6fvk-pvnp. http://dx.doi.org/10.1001/jama.2014.14387 278 indiana health law review vol. 12:1 checked the credentials and temperature of those trying to go in or out.251 only in west point were the people kept separated from the rest of the population by razor wire and bullets. by march 2015, the last ebola patient had been released from a treatment center, and life in liberia was starting to return to normal. president ellen johnson sirleaf, in an interview with the editorial board of the new york times, admitted that the west point quarantine was a terrible mistake. it did not take long to know that it did not work. it created more tension in the society. . . . we went into a security approach. we put the army there. we put the security people there. we closed the borders. . . . now i know that people’s ownership, community participation, works better in a case like this. i think that experience will stay with us.252 vii. conclusion quarantine, one of the first tools of public health for the control of communicable diseases, remains a lawful and valuable public health strategy. quarantine also raises in the starkest possible terms the fundamental ethical conflict of public health—the clash between individual and population rights and interests. in the united states, personal liberty is greatly valued and protected by law, although the supreme court has long held that liberty may be restricted through “reasonable regulation” to protect the public health. 253 consequently, it will be a significant challenge for public officials and public health experts to convince large numbers of asymptomatic people of the necessity and moral imperative of their temporarily 251 mcneil, supra note 35. 252 rick gladstone, liberian leader concedes errors in response to ebola, n.y. times, march 12, 2015, at a6, archived at http://perma.cc/2jqr-plpp. 253 jacobson v. massachusetts, 197 u.s. 11, 25 (1905). 2015 from sars to ebola 279 relinquishing a degree of their liberty for the possible benefit of the public’s health. the federal government has the constitutional authority under the commerce clause to impose quarantine to prevent the international and interstate spread of infection, and this responsibility has been delegated to the cdc. nevertheless, the states maintain primary responsibility for public health, including quarantine. many of the state quarantine laws were originally enacted in the early twentieth century. the anthrax attack in 2001 provided the impetus for updating these laws to modernize and streamline state public health emergency response. although all of the states have updated their laws, at least to some extent, these efforts must be considered works in progress. some of the model laws used as templates for modernization have been criticized for failing to include adequate protections for civil liberties and due process. virtually all of the laws lack key ancillary measures needed for successful quarantine, such as prohibiting employment discrimination against individuals in quarantine and providing for temporary income replacement so that individuals will not be tempted to violate the quarantine and go to work.254 because quarantine is one of the most intrusive and demanding of public health interventions, it tends to expose or magnify the vulnerabilities of a public health system. that is certainly the case with the 2014 ebola outbreak. in west africa, the lack of health care infrastructure, combined with extreme poverty, resulted in a widespread human tragedy. 255 in the united states, due to its complex and decentralized public health system, communication, coordination, calm, and proportionate response quickly emerged as leading concerns when a few ebola cases were diagnosed and treated. 254 see supra note 189 and accompanying text. 255 see maggie fox, ebola hurts more than sick: world bank, nbc news (jan. 12, 2015), http://www.nbcnews.com/storyline/ebola-virusoutbreak/ebola-hurts-more-sick-world-bank-n284421, archived at http://perma.cc/r6q6-svut. 280 indiana health law review vol. 12:1 quarantine procedures can only be as effective as a nation’s overall public health system and its comprehensive approach to controlling an epidemic. besides quarantine, isolation, public education, health care work force development and training, contact tracing, travel restrictions, medical surveillance, vaccine and medication development, clinical interventions, and other public health actions are important. this article has considered only one of the many important and complex aspects of a public health response to an epidemic. indeed, in every affected country an epidemic such as the ebola outbreak of 2014 represents a moral challenge on an individual and societal level.256 to maximize an effective response and to obtain public support for quarantine, public health officials contemplating, devising, or implementing a plan of action should be aware of the centrality of ethical criteria. in particular, four essential considerations for modern quarantine are the following: (1) necessity, effectiveness, and scientific rationale; (2) proportionality and least infringement; (3) humane supportive services; and (4) public justification. thoughtful application of these considerations will increase the likelihood of a successful quarantine, thereby hastening the end of a deadly disease outbreak. of equal importance, these ethical considerations are essential to maintaining the social fabric of a society during the period of quarantine and thereafter. 256 see mark a. rothstein, the moral challenge of ebola, 104 am. j. pub. health 6 (2015). http://dx.doi.org/10.2105/ajph.2014.302413 indiana health law review volume xv 2018 number 2 note once more unto the breach: how the growing threat of ransomware affects hipaa compliance for covered entities connor mclarren* i. introduction imagine you run one of the largest hospital systems on the east coast, serving hundreds of thousands of patients on a yearly basis and providing critical healthcare-related services. your electronic health records, those of every patient you have ever seen, are critical for ensuring proper medical care, treatment, payment, and are necessary for the proper day-to-day functioning of your enterprise on every imaginable level. now imagine that one day, access to your entire computer system is taken away, and put in the hands of unknown hackers. all they leave you is a ransom notice: either pay the equivalent of tens of thousands of dollars in “bitcoin,” or lose your access to this critical data forever. this is the exact experience of the medstar hospital system in the greater washington d.c. area, a five-billion dollar health-care provider with ten hospitals, 250 outpatient centers, and over 30,000 employees.1 for days, its entire system was overtaken by a dangerous and increasingly more common threat to the healthcare infrastructure of the united states: ransomware.2 a. the issue: ransomware challenges traditional notions of hipaa breaches as the healthcare industry has increasingly turned to digital records to store patients’ health records, traditional legislation such as the health insurance portability and accountability act (hipaa) that have aimed at setting standards of security for protected health information (phi) have proven incapable of keeping up with novel or unexpected vulnerabilities in the cybersecurity of * j.d. candidate, 2018, indiana university mckinney school of law; b.s., 2015, samford university 1. john woodrow cox et. al., virus infects medstar health system’s computers, forcing an online shutdown, wash. post (mar. 28, 2016), https://www.washingtonpost.com/local/virusinfects-medstar-health-systems-computers-hospital-officials-say/2016/03/28/480f7d66-f515-11e5a3ce-f06b5ba21f33_story.html [https://perma.cc/6ruu-fjpt]. 2. id. http://doi.org/10.18060/3911.0051 306 indiana health law review [vol. 15:305 healthcare organizations.3 nowhere is this more evident than in the case of “ransomware” attacks. ransomware is malware that is designed to lock hospitals out of their patient records while the responsible party issues a ransom to the hospital with a simple ultimatum: pay up or permanently lose access to all of its patient information.4 the department of health and human services (hhs) defines ransomware as follows: [ransomware is] a type of malware (malicious software) distinct from other malware; its defining characteristic is that it attempts to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker who deployed the malware, until a ransom is paid. after the user’s data is encrypted, the ransomware directs the user to pay the ransom to the hacker (usually in a cryptocurrency, such as bitcoin) in order to receive a decryption key.5 the healthcare industry is now the most common target of ransomware attacks; reports suggest that hospitals were on the receiving end of 88% of all ransomware attacks.6 while ransomware attacks are devastating to hospitals, they have also created a legal quandary: while the malware locks hospitals out of their access to patient health records, determining whether or not that data has actually been breached and accessed by a third-party can be difficult to determine and depends on the variant of ransomware used in the attack.7 thus far, over a million unique variants of ransomware have been discovered.8 b. health and human services reaction to ransomware attacks in july of 2016, the hhs office of civil rights (ocr) announced that “unless the [healthcare provider] or business associate can demonstrate that there is a ‘…low probability that the phi has been compromised,’ based on the factors set forth in the breach notification rule, a breach of phi is presumed to have occurred.”9 in order to demonstrate that there was a low probability of a breach, 3. jonathan litchman, the false promise of hipaa for healthcare cybersecurity, health it security (march 8, 2016), http://healthitsecurity.com/news/the-false-promise-of-hipaa-forhealthcare-cybersecurity [http://perma.cc/j4gx-96e5]. 4. u.s. dep’t. of health & human servs., fact sheet: ransomware and hipaa (2016), https://www.hhs.gov/sites/default/files/ransomwarefactsheet.pdf [http://perma.cc/as48jnrp]. 5. id. 6. max green, hospitals are hit with 88% of all ransomware attacks, health it & cio rev. (july 27, 2016), http://www.beckershospitalreview.com/healthcare-information-technology/ hospitals-are-hit-with-88-of-all-ransomware-attacks.html [http://perma.cc/e5jp-hlwf]. 7. matthew mellen, how to interpret hhs guidance on ransomware as a hipaa breach, health data mgmt. (july 27, 2016, 3:50 pm), http://www.healthdatamanagement.com/opinion/ how-to-interpret-hhs-guidance-on-ransomware-as-a-hipaa-breach [http://perma.cc/h2js-d67q]. 8. id. 9. u.s. dep’t. of health & human servs., supra note 4. 2018] once more unto the breach 307 a hospital must prove the following four factors, as laid out within the breach notification rule: (1) the nature and extent of the phi involved, including the types of identifiers and the likelihood of re-identification; (2) the unauthorized person who used the phi or to whom the disclosure was made; (3) whether the phi was actually acquired or viewed; and (4) the extent to which the risk to the phi has been mitigated.10 these criteria are problematic for several reasons. first, the criteria used to determine whether or not there was a low probability of a breach is highly factspecific,11 and might provide incentive to hospitals not to report a ransomware attack. second, there is no guarantee that total compliance with hipaa guidelines can prevent a breach from occurring,12 and third, even encrypted data can be considered unencrypted by hhs if the ransomware attack also manages to overwrite the electronic protected health information (“ephi”) with its own encryption.13 this note will set out to accomplish three primary goals. first, i will conduct an analysis of what ransomware is, along with other cybersecurity threats facing the healthcare industry today, as well as the steps that are being taken to counter the threat of ransomware in both the private and public sectors. second, i will argue that current legislation and rulings regarding ransomware are inadequate in this matter based on current cybersecurity trends. finally, i will provide two possible alternative routes with which the damage caused by ransomware could be mitigated. i. background & history a. major cybersecurity attacks within the healthcare industry as more and more health records have been made electronic,14 they have 10. id. 11. id. 12. dennis fisher, hhs issues vague guidance on ransomware and hipaa disclosures, on the wire (july 21, 2016), https://www.onthewire.io/hhs-issues-vague-guidance-onransomware-and-hipaa-disclosures/ [http://perma.cc/rs5l-pjzy]. 13. amy gordon et. al., guidance on ransomware attacks under hipaa and state data breach notification laws, national law review (aug. 8, 2016), http://www.natlawreview.com/ article/guidance-ransomware-attacks-under-hipaa-and-state-data-breach-notification-laws [http://perma.cc/4v6u-llzf]. 14. office-based physician electronic health record adoption, office of the nat’l coordinator for health info. tech. (dec. 2016), https://dashboard.healthit.gov/quickstats/ pages/physician-ehr-adoption-trends.php [http://perma.cc/65xs-tsd4] (outlining that the adoption of electronic medical records by doctors within the united states has more than doubled since 2008, from 42% to 87% by the end of 2016). 308 indiana health law review [vol. 15:305 become increasingly exposed to threats from hackers. the first health-care related breaches were reported in 2005, but in 2009 attackers managed to collect over four million health records.15 “between 2012 and 2014, cybercriminals started to ramp up attacks on the healthcare industry, which remarkably suffered more than the business, military, and government sectors. in fact, the number of health care service provider victims has grown almost fourfold in 2014 from when it was first observed in 2005.”16 as time has gone on, attacks have become increasingly sophisticated, to the point that physical contact with hospital computer systems is no longer necessary or even required for a successful cyberattack.17 hackers can now use a combination of more traditional methods such as phishing scams over email, and far more unorthodox and innovative approaches such as making cyberattacks through unprotected medical devices.18 b. why are covered entities such prime targets for ransomware? hospitals have become a popular target because their cybersecurity is generally not as good as other industries and because hospitals require patient data records in order to properly function.19 electronic health records can be sold online for $10 to $50 each, making them an easy and profitable target for hackers to focus on.20 hospitals are easy prey, as the primary focus of hospitals – when it comes to digitalization – is hipaa compliance rather than cybersecurity.21 “you can’t just roll out new software,” explains josephine wolff, a computing security expert at the rochester institute of technology, on why implementing new cybersecurity procedures can be so difficult for covered entities.22 “the medical world is dealing with a very complicated legal and policy regime around medical data and how it has to be handled.”23 15. medical data in the crosshairs: why is healthcare an ideal target?, trend micro (aug. 14, 2015), http://www.trendmicro.com/vinfo/us/security/news/cyber-attacks/medical-data-inthe-crosshairs-why-is-healthcare-an-ideal-target [http://perma.cc/b36g-mqhh]. 16. id. 17. id. 18. kelly j. higgins, hospital medical devices used as weapons in cyberattacks, dark reading (june 8, 2015, 4:00 pm), http://www.darkreading.com/vulnerabilities---threats/hospitalmedical-devices-used-as-weapons-in-cyberattacks/d/d-id/1320751 [http://perma.cc/9brn-bq6a]. 19. annie sneed, the most vulnerable ransomware targets are the institutions we rely on most, sci. am. (mar. 23, 2016), https://www.scientificamerican.com/article/the-most-vulnerableransomware-targets-are-the-institutions-we-rely-on-most/ [https://perma.cc/al7v-dcya]. 20. nate berg, hackers have figured out how easy it is to take down a hospital, splinter (mar. 10, 2016, 4:17 pm), http://splinternews.com/hackers-have-figured-out-how-easy-it-is-to-takedown-a-1793855277 [https://perma.cc/cuu5-8skj]. 21. kim zetter, why hospitals are the perfect targets for ransomware, wired (mar. 30, 2016, 1:31 pm), https://www.wired.com/2016/03/ransomware-why-hospitals-are-the-perfecttargets/ [https://perma.cc/fx2e-dyv5]. 22. sneed, supra note 19. 23. id. 2018] once more unto the breach 309 ransomware is not only a threat to administrative functions: the department of homeland security (dhs) has issued statements of concern regarding the vulnerability of medical devices to ransomware attacks.24 as marty edwards, director of dhs’s industrial control systems cyber emergency response team, succinctly summed up the threat, “it’s only a matter of time before we see some sort of significant type of events that involve patient safety that are cyber enabled[.]”25 he further noted that 2017 could see the first of such ransomware attacks against patient medical devices.26 further complicating this matter is a shortage of security professionals that hospital systems and other covered entities can reliably call upon for assistance.27 c. hipaa and cybersecurity hipaa has been around since the 1990’s and has formed the foundation for protected health records, but only recently has congress acted to reinforce the security of electronic health records. hipaa, of course, governs the usage of phi by covered entities: these entities can range from traditional medical practitioners and providers to medical billing-houses and including, most recently, business associates of healthcare providers who interact with phi.28 essentially, if you interact with identifiable phi, you are a covered entity.29 in 2009, congress passed the health information technology for economic and clinical health (hitech) act, which, in addition to encouraging the adoption of electronic health records and other health information technology, also lays out privacy rules for how to protect electronic phi.30 hitech requires that technologies and policies must comply with hipaa privacy and security laws.31 most notably, the 24. greg slabodkin, ransomware emerging as medical device cybersecurity threat, health data mgmt. (feb. 20, 2017, 6:50 am est), http://www.healthdatamanagement.com/ news/ransomware-emerging-as-medical-device-cybersecurity-threat [https://perma.cc/4xdqjqd7]. 25. id. 26. id. 27. andrea peterson, why hackers are going after health-care providers, the washington post (mar. 28, 2016), https://www.washingtonpost.com/news/the-switch/wp/2016/03/28/whyhackers-are-going-after-health-care-providers/ [https://perma.cc/4yak-n5qz]. 28. hipaa ‘protected health information’: what does phi include?, hipaa.com (sept. 1, 2009), https://www.hipaa.com/hipaa-protected-health-information-what-does-phi-include/ [https://perma.cc/wyx4-sz6a]; see also business associates, u.s. dep’t. of health & human se r v s . , h t tps:/ /www.hhs.gov/hipaa/for-professionals/privacy/guidance/businessassociates/index.html [https://perma.cc/fau6-frxp] (last updated july 26, 2013). 29. id. 30. hitech act enforcement interim final rule, u.s. dep’t. of health & human servs. (june 16, 2017), http://www.hhs.gov/hipaa/for-professionals/special-topics/hitech-actenforcement-interim-final-rule/ [https://perma.cc/zn5f-asd9]. 31. margaret rouse, hitech act (health information technology for economic and clinical health act), techtarget, http://searchhealthit.techtarget.com/definition/hitech-act 310 indiana health law review [vol. 15:305 hitech act requires that any data breach suffered by a covered entity or business associate that affects 500 or more individuals be reported to hhs as well, in certain circumstances, as major media in the area.32 however, as healthcare systems have moved more and more into the electronic realm, the bigger target for hackers they have become: while 2014 saw 68% of healthcare data breaches result from theft or loss of employee devices, in 2015 98% of all breaches of data came from hacking.33 it has been estimated that over the past three years, 40% of all data breaches in the united states came from the healthcare industry.34 additionally, 91% of all health organizations have reported a data breach within the last two years.35 the federal government has repeatedly attempted to halt the rise of cyberattacks on the us healthcare system. in 2013, president obama issued executive order 13636, calling for the development of increased cybersecurity for critical cyber-infrastructure, including the healthcare industry.36 in 2016, the president also issued a factsheet related directly to the issue of cybersecurity that laid out a detailed plan for how to deal with the issue that would include over a three billion dollar information technology modernization stimulus, the creation of more cyber defense teams for dhs, and further investment in cybersecurity education.37 even a congressional bill on cybersecurity included a section dedicated purely to improving cybersecurity standards in the healthcare industry.38 despite increased awareness and guidelines on the issue, cybersecurity continues to be something the healthcare industry as a whole grapples with. in 2015 alone, 113 million electronic health records were compromised, and in 2016, the industry has averaged 4 reportable data breaches per week.39 [https://perma.cc/9e2s-be6g] (last updated dec. 2014). 32. hipaa/hitech enforcement action alert, the nat’l l. rev. (mar. 22, 2012), http://www.natlawreview.com/article/hipaahitech-enforcement-action-alert [https://perma.cc/v9h79t96]. 33. heather landi, hacking accounted for 98 percent of healthcare data breaches in 2015, report says, healthcare informatics (feb. 1, 2016), http://www.healthcareinformatics.com/news-item/hacking-accounted-98-percent-healthcare-data-breaches-2015-reportsays [https://perma.cc/t7fs-rgpb]. 34. addressing gaps in cybersecurity: ocr releases crosswalk between hipaa security rule and nist cybersecurity framework, u.s. dep’t. of health & human servs. (feb. 23, 2016), (http://www.hhs.gov/hipaa/for-professionals/security/nist-security-hipaa-crosswalk/ [https://perma.cc/mzv3-raxm]. 35. id. 36. improving critical cybersecurity infrastructure, 78 fed. reg. 11737 (feb. 12, 2013). 37. office of the press secretary, fact sheet: cybersecurity national action plan (feb. 9, 2016), https://www.whitehouse.gov/the-press-office/2016/02/09/fact-sheetcybersecurity-national-action-plan [https://perma.cc/u5kx-9e5x]. 38. s.754, 114th congr. § 405 (2015). 39. nsikan akpan, has health care hacking become an epidemic?, pbs (mar. 23, 2016, 6:19 pm), http://www.pbs.org/newshour/updates/has-health-care-hacking-become-an-epidemic/ 2018] once more unto the breach 311 d. rise of ransomware as a critical threat ransomware has been around since the 1980’s, but the rise of cyber-currency such as bitcoin has given hackers an anonymous way to receive payment without fear of discovery, and thus has fueled ransomware’s resurgence.40 this is not news to most information technology security firms, who have been warning healthcare organizations of the threat ransomware poses to their information for years now that: “ransomware has been an inconvenient truth for a while, a tried and tested dance where an attack is launched and the ransom is modest, just enough where many organizations pay it to make the problem go away…[b]ut demands for funds are soaring, and the problem is organizations are paying. ransomware will get worse before it gets better.”41 incidents involving ransomware have only grown more prevalent as time has gone on.42 as of 2016, there have been over 4,000 daily ransomware attacks, a 300% increase from 2015.43 it is estimated that by the end of 2016, hackers will have pulled in an estimated one billion dollars using ransomware, making it an incredibly lucrative business.44 hospitals are now one of the most heavily targeted places, with nearly half of all u.s. hospitals reporting at least one ransomware attack in the past year.45 although the fbi has publicly advised hospital systems against paying the ransom,46 it has also admitted that paying the ransom may be a necessity in order to regain access to patient records.47 as one fbi representative cynically summed [https://perma.cc/69tb-d5yd]. 40. sneed, supra note 19. 41. bill siwicki, tips for protecting hospitals from ransomware as cyberattacks surge, healthcare it news (apr. 6, 2016, 6:59 am), http://www.healthcareitnews.com/news/tipsprotecting-hospitals-ransomware-cyber-attacks-surge [https://perma.cc/v768-rqad]. 42. see also stu skouwerman, ransomware on the rise: the evolution of a cyberattack, tech beacon (nov. 5, 2016), http://techbeacon.com/ransomware-rise-evolution-cyberattack [https:// perma.cc/tu9b-4632] (establishing the timeline of ransomware attacks). 43. u.s. dep’t. of health & human servs, supra note 4. 44. danny palmer, the cost of ransomware attacks: $1 billion this year, zd net (sept. 8, 2016, 11:46 gmt), http://www.zdnet.com/article/the-cost-of-ransomware-attacks-1-billion-thisyear/ [https://perma.cc/e8cn-bbkm]. 45. steven d. gravely & erin s. whaley, ransomware in healthcare – a clear and present danger, troutman sanders (july 14, 2016), https://www.troutmansanders.com/ransomware-inhealthcare---a-clear-and-present-danger-07-14-2016/ [https://perma.cc/8f3j-cp6z]. 46. incidents of ransomware on the rise, fed. bureau of investigation (apr. 29, 2016), https://www.fbi.gov/news/stories/incidents-of-ransomware-on-the-rise [https://perma.cc/6unhauly]. 47. fbi’s advice on ransomware? just pay the ransom., the security ledger (oct. 22, 312 indiana health law review [vol. 15:305 up, “to be honest, we often advise people just to pay the ransom.”48 it has been estimated that for every unplanned downed minute away from data centers, a hospital can lose an average of $7,900 per minute, further incentivizing prompt payment.49 this accounts for both direct and indirect costs of downtime away from data, and includes factors such as equipment damage, loss in confidence among consumers, as well as other costs including legal fees and hipaa penalties for a breach.50 even if the hospital goes without paying the ransom, it can still lead to several days’ worth of delays while hospitals attempt to clean out their network, which can compromise patient safety and lead to inefficient treatment.51 it is perhaps no wonder, then, that there is a temptation to pay the ransom in short order: the average incident involving downtime spent as a result of inaccessible data—only 86 minutes—can cost a hospital a total of $690,200.52 so far in 2016, there have been three major, publicized attacks on hospitals that paint a disturbing picture of increased boldness and sophistication by the attackers. the attack on medstar in march, regarded as the most damaging attack of the year, effectively forced 10 hospitals and 250 outpatient centers to shut down their computer network, delay treatments and appointments, and turn away thousands of patients to other hospitals.53 the grim situation that the medical staff faced without the ability to access the medical information of their patients was well encapsulated by the media: “without access to email and computer systems, the medical staff fell back on seldom-used paper records that had to be faxed or hand-delivered. but…[t]hey can be missing vital pieces of patient information: complete medical histories, every drug prescribed, allergies to medicine and treatment plans.”54 medstar personnel were quick to assure that no patient records were illegally accessed by third parties during the crisis.55 evidence later indicated that while the it 2015), https://securityledger.com/2015/10/fbis-advice-on-cryptolocker-just-pay-the-ransom [https://perma.cc/dn6n-yxxe]. 48. id.; see also haley sweetland edwards, a devastating type of hack is costing people big money, time (apr. 21, 2016), http://time.com/4303129/hackers-computer-ransom-ransomware/ [https://perma.cc/x9ew-56r9]. 49. kacy zurkus, the rise of ransomware in healthcare, cso (july 11, 2016, 3:50 am), h ttp:/ /www.csoonline.com/art icle/3091080/security/ t h e -rise-of-ransomware-in healthcare.html#slide4 [https://perma.cc/6vcd-qw55]. 50. see generally yevgeniy sverdlik, one minute of data center downtime costs us$7,900 on average, datacenter dynamics (dec. 4, 2013), http://www.datacenterdynamics.com/ content-tracks/power-cooling/one-minute-of-data-center-downtime-costs-us7900-onaverage/83956.fullarticle [https://perma.cc/6vcd-qw55]. 51. brian contos, ransomware attacks force hospitals to stich up networks, cso (may 19, 2016, 8:24 am), http://www.csoonline.com/article/3072503/backup-recovery/ransomware-attacksforce-hospitals-to-stitch-up-networks.html [https://perma.cc/7gdy-x4bq]. 52. see generally sverdlik, supra note 50. 53. cox, supra note 1. 54. id. 55. id. 2018] once more unto the breach 313 department was not at fault, an improperly installed server likely created a vulnerability in their cybersecurity suite and gave hackers an ability to bypass cybersecurity measures in place.56 in another notable incident, hollywood presbyterian medical center in los angeles was forced to pay approximately seventeen thousand dollars-worth of bitcoins after ransomware locked medical personnel out of its patient records.57 the hospital paid the ransom, viewing it as “the quickest and most efficient way to restore…operations.”, but even after a week of being locked out of their electronic health records while hospital staff attempted to remove the ransomware from their systems,58neglected to inform local or federal law enforcement of the attack until after they had already paid.59 hospital management claims that hospital records were never accessed during the attack, but medical personnel were forced to revert back to pen and paper to continue hospital functions.60 a similar event happened in kansas later in 2016. kansas heart hospital, despite being aware of the looming threat ransomware was posing upon the industry and taking the time to have a plan in place in case they were ever attacked, was hit with ransomware and was still forced to pay a ransom in order to ensure the release of its patient data.61 afterward, rather than unlocking the data, the hackers demanded a second ransom payment of an undisclosed amount.62 the hospital balked at this second demand after outside consultants advised against paying any additional ransom fee.63 while its data was returned shortly thereafter, the attack on kansas heart hospital may portend future additional extortions from attackers against hospitals, even when they pay the ransom.64 until the hhs announcement in summer 2016 specifically regarding ransomware,65 there were concerns that because in many of these situations no technical breach of electronic phi occurs, hospitals would simply pay the ransom 56. sean gallagher, maryland hospital: ransomware success wasn’t it department’s fault, ars technica (apr. 7, 2016, 10:12 am), https://arstechnica.com/security/2016/04/marylandhospital-group-denies-ignored-warnings-allowed-ransomware-attack/ [https://perma.cc/2dsrmyfd]. 57. richard winton, hollywood hospital pays $17,000 in bitcoin to hackers; fbi investigating, l.a. times (feb. 18, 2016), http://www.latimes.com/business/technology/la-me-lnhollywood-hospital-bitcoin-20160217-story.html [http://perma.cc/h5d7-pf2n]. 58. green, supra note 6. 59. winton, supra note 57. 60. id. 61. bill siwicki, ransomware attackers collect ransom from kansas hospital, don’t unlock all the data, then demand more money, healthcare it news (may 23, 2016, 2:58 pm), http://www.healthcareitnews.com/news/kansas-hospital-hit-ransomware-pays-then-attackersdemand-second-ransom [http://perma.cc/9y63-kz6w]. 62. id. 63. id. 64. id. 65. see generally u.s. dep’t. of health & human servs, supra note 4. 314 indiana health law review [vol. 15:305 and not report any breach of patient data.66 e. the u.s. federal government’s response to the growing threat of hipaa data breaches after months of major ransomware attacks across the country, congress pushed to get hhs to recognize ransomware attacks as breaches.67 representatives ted lieu (d, cal.) and will hurd (r, tex.) sent a letter to the ocr requesting that it recognize ransomware attacks as some sort of breach.68 in this letter, both congressmen acknowledged the unusual nature of the threat ransomware poses, wherein ransomware is largely a problem towards patient safety rather than privacy, but requested clarification and guidance from the hhs.69 finally, in the summer of 2016, hhs released a fact sheet for the healthcare industry that outlined how it views ransomware attacks.70 its response provided basic answers regarding ransomware, including how it defines ransomware, how hipaa compliance could help protect covered entities, and what to do if an organization found itself on the receiving end of an attack.71 in addition to that information, hhs also provided some crucial insight as to what it considers a ransomware attack to be in regards to hipaa.72 effectively, hhs considers any successful ransomware attack to be a breach of phi, and therefore requires the covered entity to make a report to hhs under hipaa.73 in several sections throughout the fact sheet, hhs explicitly states that hipaa compliance ¾with measures such as creating and maintaining quality backup copies of data off of the network, emergency disaster recovery and operations planning, and reviewing cybersecurity measures already in place¾is enough to 66. dan munro, is ransomware considered a health data breach under hipaa?, forbes (mar. 29, 2016, 9:26 pm), http://www.forbes.com/sites/danmunro/2016/03/29/is-ransomwareconsidered-a-health-data-breach-under-hipaa/#12b8d5cd597d [http://perma.cc/8hbb-8n44]. 67. elizabeth snell, reps push for stronger healthcare ransomware guidance, health it security (july 7, 2016), http://healthitsecurity.com/news/reps-push-for-stronger-healthcareransomware-guidance [http://perma.cc/mu7a-h7wu]; see also elizabeth snell, senator urges hhs to create healthcare cybersecurity law, health it security (mar. 30, 2016), http://healthitsecurity.com/news/senator-urges-hhs-to-create-healthcare-cybersecurity-law [http://perma.cc/w5hc-8e48]. 68. u.s. representative ted lieu, representatives lieu and hurd urge hhs to hone focus on ransomware guidance, press release (june 28, 2016), https://lieu.house.gov/media-center/press-releases/representatives-lieu-and-hurd-urge-hhs-honefocus-ransomware-guidance [http://perma.cc/3t4a-lx52]. 69. id. 70. see generally u.s. dep’t. of health & human servs., supra note 4. 71. see generally id. 72. see generally id. 73. id.at 5, 6. 2018] once more unto the breach 315 prevent or mitigate a ransomware attack.74 hhs also clarified its stance on how an organization can show that a breach had not occurred even if an attack is successful, but made it clear that its default position would require a fact-specific analysis to prove that no breach has occurred.75 in other words, an attack is to be reported as if it were a breach unless a covered entity can demonstrate a low probability of a breach.76 hhs took several steps to justify this conclusion. hhs considers ransomware to constitute a security incident under hipaa; “[a] security incident is defined as the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.”77 the hipaa breach notification rule defines “breach” as “‘the acquisition, access, use, or disclosure of phi in a manner not permitted under [the hipaa privacy rule] which compromises the security or privacy of the phi.’”78 because a hacker who has used ransomware has technically “acquired” the information, hhs views this as a reportable breach.79 however, the savings clause of this same section also provides that if the covered entity believes the chances of a breach of phi to be low, defined as not something that was defined or given an objective standard other than the four-part test within the hhs ransomware memo,80 they may conduct the following risk assessment test using the guidelines mentioned earlier in this note: (1) the nature and extent of the phi involved, including the types of identifiers and the likelihood of re-identification; (2) the unauthorized person who used the phi or to whom the disclosure was made; (4) whether the phi was actually acquired or viewed; and (5) the extent to which the risk to the phi has been mitigated.81 in addition to the rules laid out in the savings clause, hhs has also outlined three general exceptions to the breach notification rule: the first exception applies to the unintentional acquisition, access, or use of protected health information by a workforce member or person acting under the authority of a covered entity or business associate, if such acquisition, access, or use was made in good faith and within the scope of authority.82 the second exception applies to the inadvertent disclosure 74. id.at 2, 3. 75. id. at 6. 76. id. at 6. 77. id. at 4. 78. id. at 5. 79. id. at 5-6. 80. id. at 6. 81. id. 82. breach notification rule, u.s. dep’t of health & human servs., 316 indiana health law review [vol. 15:305 of protected health information by a person authorized to access protected health information at a covered entity or business associate to another person authorized to access protected health information at the covered entity or business associate, or organized health care arrangement in which the covered entity participates. in both cases, the information cannot be further used or disclosed in a manner not permitted by the privacy rule.83 the final exception applies if the covered entity or business associate has a good faith belief that the unauthorized person to whom the impermissible disclosure was made, would not have been able to retain the information.”84 a reportable breach also opens up a covered entity to mandatory financial penalties under hipaa, which can range anywhere from $100 to $1,500,000 depending on the severity of the breach and the whether the covered entity had “willful[ly] neglect[ed]” to comply with hipaa.85 these penalties can be waived, but it is entirely at the discretion of the ocr, and is otherwise a normal consequence of a breach.86 these exceptions to the breach notification rule create a highly fact-specific examination where hospitals and other covered entities must determine whether or not to notify hhs of a breach based off of whether they believe the patient data in their hands was legitimately compromised or not. whether or not the data has actually been transferred to the responsible party or not depends entirely on the variant of ransomware utilized.87 most variants, as of now, do not actually exfiltrate their data to a third-party.88 instead, they merely lock out users until a ransom has been paid.89 on top of that, determining which variant of ransomware a covered entity has been hit by can be difficult without the right technical support, something the healthcare industry does not currently have at its disposal.90 this is not a workable framework going forward, and must be changed http://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html [https://perma.cc/ng97lslp]. 83. id. 84. id. 85. what are the penalties for hipaa violations? hipaa j. (june 24, 2015), h t tp:/ /www.hipaajournal.com/what-are-the-penalt ies-for-h ipaa-violations-7096/ [https://perma.cc/f9nh-fnhl]. 86. id. 87. see generally mellen, supra note 7 (explaining how hhs requires an analysis of ransomware to determine if data exfiltration has occurred, a capability that is not currently widely available); but see andra zaharia, what is ransomware and 15 easy steps to keep your system protected, heimdal security (july 7, 2016), https://heimdalsecurity.com/blog/what-isransomware-protection/ (describing the many capabilities ransomware can possess, including exfiltration). [https://perma.cc/7ucz-esej]. 88. mellen, supra note 7. 89. id. 90. id. 2018] once more unto the breach 317 to allow for more clarification on when a healthcare provider is required to report instead of allowing for a greater amount of leeway. b. the response of other countries to the growing threat of healthcare-related data breaches 1. the european union countries within the european union have also suffered ransomware attacks in recent years, although nothing as high profile as any of the recent attacks in the united states.91 however, european union nations have also proved more reluctant to pay hackers when they have been directly threatened. despite successful ransomware infections in hospitals throughout the united kingdom, adequate preexisting safety measures allowed hospitals within the united kingdom’s national health service to avoid paying a ransom and to resume normal operations in relatively short order.92 similarly, hospitals in germany have also suffered ransomware attacks, but were able to avoid paying by shutting down their systems and relying on backup data.93 cooperation between private entities and public law enforcement has also helped educate entities within the european union as to how best to combat ransomware.94 unlike the united states, the european union has explicitly enshrined the protection of personal data, including personal health information, in both its treaty on the functioning of the european union as well as its charter of fundamental human rights.95 this has generally led to increases in privacy protection as a result, leaving the european union better prepared to meet threats to patient data protection in the healthcare industry:96 the eu framework begins with the presumption of privacy for sensitive health records. in a sense an electronic health system of collection and sharing must then prove itself to meet those privacy standards. . . . [i]n 91. john leyden, medical superbugs: two germany hospitals hit with ransomware, the register (feb. 26, 2016, 5:08 pm), http://www.theregister.co.uk/2016/02/26/german_hospitals_ ransomware/. [https://perma.cc/2uqe-yl5u]. 92. joseph cox, ransomware targets uk hospitals, but nhs won’t pay up, motherboard (aug. 30, 2016, 8:30 am), http://motherboard.vice.com/read/ransomware-targetsuk-hospitals-but-nhs-wont-pay-up [https://perma.cc/hr99-pmcm]. 93. leyden, supra note 91. 94. no more ransom: law enforcement and it security companies join forces to fight ransomware, europol (july 25, 2016), https://www.europol.europa.eu/newsroom/news/no-moreransom-law-enforcement-and-it-security-companies-join-forces-to-fight-ransomware. [https://perma.cc/4s3g-5cp4]. 95. european commission, data protection in the eu, http://ec.europa.eu/health/data_ collection/data_protection/in_eu/index_en.htm. [https://perma.cc/l9jh-palf]. 96. janine hiller, et. al, privacy and security in the implementation of health information technology (electronic health records): u.s. and eu compared, 17 b.u.j. sci. & tech. l.1 (2011). 318 indiana health law review [vol. 15:305 comparison, the u.s. framework, while making progress in the protection of health information, lacks the historical presumption of privacy[.]97 until recently, the european union’s primary data protection law was based around directive 95/46/ec.98 this directive allowed the individual member-states to create their own data protection legislation, so long as they adhered to the minimum standards laid out by the directive, including adhering to its definition of personal data and the principles by which data was to be protected.99 in an effort to harmonize data protection across the union, european union lawmakers recently passed the general data protection regulation, designed to simultaneously simplify the regulatory environment and provide greater security to personal data.100 it is due to become the law of the land in 2018.101 the sanctions specified in the new regulation are not automatically enforced upon a breach, but can be incredibly punishing for the worst offenders: in the worst cases, an offending corporation may be liable for up to 4% of their total worldwide profit.102 additionally, while the new regulation requires more prompt reporting to the supervisory authorities and affected persons, it does not mandate a public reporting requirement to local media as hipaa does for data breaches in the united states;103 as a result, this may make it more difficult to determine the prevalence of ransomware in european union nations.104 2. australia & new zealand australia and new zealand have also seen a significant spike in ransomware attacks against their healthcare infrastructure as healthcare information has become more digital. despite its more modestly-sized economy and population compared to economic powerhouses such as the united states or european union, australia still suffered 6% of all global ransomware detections in the first quarter of 2015, the second highest number in the world.105 most notably in the 97. id. 98. council directive 95/46 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, 1995 o.j. (l 281), (ec) [hereinafter data protection directive]. 99. id. 100. regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing directive 95/46/ec, 2016 o.j. (l 119) [hereinafter general data protection regulation]. 101. id. at 87. 102. see general data protection regulation, 2016 o.j. l.119, 2016/679. 103. id. 104. see generally laurens cerulus, hackers hold the health care sector ransom, politico (nov. 29, 2016, 5:01 pm cet), http://www.politico.eu/article/ransomware-in-health-care-draft/ (explaining that stricter data breach notification requirements make ransomware a more visible problem in the us than in the european union) [https://perma.cc/7e29-9e5d]. 105. bonnie gardiner, australia records 6 per cent of global ransomware detections, cio (may 21, 2015), http://www.cio.com.au/article/575500/australia-sees-second-highest-numberransomware-attacks-q1-2015/ [https://perma.cc/kh8a-w6zr]. 2018] once more unto the breach 319 healthcare field, the royal melbourne hospital was targeted by cybercriminals in 2016;106 while the strain of malware utilized in the attack did not actually carry ransomware, cyber security experts have warned that this strain is now capable of delivering a ransomware attack if a hacker modifies the malware accordingly.107 despite having a population six times smaller than australia, new zealand also suffered a high-profile ransomware attack in 2016, when the whanganui district health board was targeted by russian cybercriminals.108 despite a brief outage, the health board was able to contain the ransomware virus and paid no ransom to the hackers.109 although both nations have suffered attacks, they also have very strong data protection laws governing the healthcare field. in particular, australia’s privacy act of 1988, their hipaa equivalent, has very stringent terms regarding the security of health information, including a broad definition of health services that includes any entity holding onto health information for the purposes of assessing, maintaining, improving, or managing a person’s health.110 there are, however, some structural reasons why australia and new zealand see a seemingly disproportionate number of attacks in spite of their smaller economies. first, organizations in both countries are the most likely to employ data protection strategies that merely monitor, rather than monitor and block, ransomware incidents, meaning that while initial detection is strong, countermeasures for an actual attack likely come down to the preparation of the individual organization rather than compliance with data protection laws.111 organizations within the united states, in contrast, are the most likely to employ a monitor and block 106. zak khan, healthcare held to ransom: how to protect australian healthcare systems and patients from cybercrime, cso (april 1, 2016), http://www.cso.com.au/article/597125/healthcareheld-ransom-how-protect-australian-healthcare-systems-patien ts-from-cybercrime/ [https://perma.cc/2a6f-bpkd]. 107. see tom spring, qbot malware morphs quickly to evade detection, threat post (apr. 13, 2016, 1:28 pm), https://threatpost.com/qbot-malware-morphs-quickly-to-evade-detection/ 117377/ [https://perma.cc/6mqj-fytg]. 108. sophie ryan, hackers attack hospital system, wanganui chron. (feb. 24, 2016, 8:39 am) , h t t p : / /w w w .n zh era ld . co .n z /w a n g a n u i -c h ron ic le /n ews /a r t ic le . c fm ?c_ id=1503426&objectid=11594628 [https://perma.cc/5pg5-jhgc]. 109. id. 110. health information and medical research, office of the australian info. commissioner (last viewed mar. 15, 2017), https://www.oaic.gov.au/privacy-law/privacyact/health-and-medical-research [https://perma.cc/nk52-zx8l]. 111. shannon williams, ransomware and mobile malware hits peak, healthcare least prepared, security brief nz (sep. 21, 2016), https://securitybrief.co.nz/story/ransomware-andmobile-malware-hits-peak-healthcare-least-prepared/ [https://perma.cc/uv5y-dh2u]; see also grame burton, australian government might force isps to block malware and websites associated with online scams, v3 (apr. 26, 2017), https://www.v3.co.uk/v3-uk/news/3009069/australiangovernment-might-force-isps-to-block-malware-and-websites-associated-with-online-scams [https://perma.cc/x86t-g66a]. 320 indiana health law review [vol. 15:305 strategy.112 additionally, despite how stringent their health information laws are, neither australia nor new zealand currently have any data breach reporting requirements on the books, 113 although both countries are mulling provisions that would make reporting mandatory under certain conditions.114 if passed, these laws could help shed more light on the number of ransomware attacks actually occurring against australia and new zealand, and lead to further measures being taken to bolster cybersecurity laws already in place. 3. canada canada has not been immune to the scourge of ransomware either, suffering over 1,600 ransomware attacks per day in 2015.115 the canadian healthcare system has also been targeted by ransomware attackers, with one high profile attack occurring in ottawa in spring of 2016.116 each ransomware incident costs canadian hospitals approximately $355,117 and it is estimated that health it in the nation is approximately five years behind the it capabilities of other industries.118 on top of that, canadian companies and entities are also more willing to pay the ransom when asked, being 75% more likely to pay the ransom demand than other countries.119 in spite of that, canadians feel more confident in their data protection systems than their american counterparts, with 51% of canadians feeling confident in their ability to stop ransomware despite 72% of canadian companies suffering a ransomware attack in 2015.120 canadian healthcare entities are similar in preparation level to their united 112. id. 113. mandy simpson, healthcare providers face rising cyber security risks in 2017, cyber toa (jan 16, 2017), https://medium.com/cyber-toa/healthcare-providers-face-rising-cyber-securityrisks-in-2017-b8d6ad6c895b [https://perma.cc/294d-fytn]. 114. jeremy kirk, australia, new zealand still milling data breach laws, bank info security (may 24, 2016), http://www.bankinfosecurity.com/australia-new-zealand-still-mullingdata-breach-laws-a-9134 [https://perma.cc/4q5e-e35t]. 115. nicole bogart, ransomware on the rise in canada: how to protect your data, global news (april 17, 2016, 9:00 am) http://globalnews.ca/news/2641249/ransomware-on-the-rise-incanada-how-to-protect-your-data/ [https://perma.cc/anz2-9z9q]. 116. ottawa hospital hit with ransomware, information on four computers locked down, nat’l post (march 13, 2016, 2:10 pm edt), http://news.nationalpost.com/news/canada/ottawah osp it a l-h it -w ith -r an som w are-in form at ion -o n f o u r -c o m p u t e r s -locked-dow n [https://perma.cc/t2tb-dusr]. 117. david masson, protecting patient information in modern health care, huffington post can. (jan. 27, 2017, 4:59 am est), http://www.huffingtonpost.ca/david-masson/protectingpatient-information_b_14419396.html [https://perma.cc/ggv9-7xg7]. 118. christine wong, the unhealthy state of cio influence in canadian health care, it world canada (june 30, 2015), http://www.itworldcanada.com/article/the-unhealthy-state-of-cioinfluence-in-canadian-health-care/375654 [https://perma.cc/3scu-ybup]. 119. nathan kornet, are canadian companies really prepared for ransomware? asigra: blog (feb. 8, 2017) http://www.asigra.com/blog/are-canadian-companies-really-preparedransomware# [https://perma.cc/n8am-24bb]. 120. id. 2018] once more unto the breach 321 states counterparts; 96% of american companies were not very confident in their ability to stop a ransomware attack, and only 9% of canadian organizations out of 103 surveyed were deemed to be highly secure and prepared for any sort of cyberattack.121 canadian laws regulating the private sector in regards to data protection are similar to those found in the european union.122 unlike either the united states or the european union however, canada has only recently passed a bill that would require entities to notify individuals of a breach of their personal health information.123 this new law would also require private entities to keep track of data breaches, even if they would not ordinarily constitute a reportable breach.124 ii. analysis: the decision by hhs does not adequately meet the challenges imposed by ransomware a. reaction to the hhs announcement 1. federal government congress has contemplated passing legislation that would force hhs to recognize ransomware attacks as reportable data breaches,125 as well as legislation that would further criminalize the usage of ransomware and other similar malware attacks.126 thus far, such legislation has stalled. in terms of overall cybersecurity, congress has only passed one major cybersecurity investment package, which took five years to assemble and neglected to include ransomware as a chief threat.127 digital education, or lack thereof, seems to play a key part in why 121. oliva bowden, canadian companies are vulnerable to the increasing risk of cyber attacks, financial post (aug. 29, 2016, 5:00 am est), http://business.financialpost.com/ executive/smart-shift/canadian-companies-are-vulnerable-to-the-increasing-risk-of-cyber-attacks [https://perma.cc/9q9y-w2hq]; see also international study finds nearly 40 percent of enterprises hit by ransomware in the last year, malwarebytes (aug. 3, 2016), https://press.malwarebytes.com/2016/08/03/international-study-finds-nearly-40-percent-ofenterprises-hit-by-ransomware-in-the-last-year/ [https://perma.cc/xpu6-hxpn] (stating that 96% of american organizations are not confident in their ability to prevent ransomware attacks). 122. timothy m. banks & karl schober, data security and cybercrime in canada, lexology (sept. 25, 2016), http://www.lexology.com/library/detail.aspx?g=237135ad-df344e79-87fa-554b3dfdc7fa [https://perma.cc/7eg4-vmaz]. 123. id. 124. id. 125. dennis fisher, ransomware attacks mat trigger breach notifications, on the wire (june 28, 2016), https://www.onthewire.io/ransomware-attacks-may-trigger-breach-notifications/ [https://perma.cc/dhz2-fkrn]. 126. sean lyngaas, with ransomware on the rise, senate botnet bill gets another shot, fcw (may 19, 2016), https://fcw.com/articles/2016/05/19/botnet-whitehouse-bill.aspx [https://perma.cc/ 7zsk-cblc]. 127. cory bennett, congress approves first major cyber bill in years, the hill (dec. 18, 2015, 12:07 pm est), http://thehill.com/policy/cybersecurity/263696-congress-approves-first322 indiana health law review [vol. 15:305 government has been hesitant to tackle this issue more heavily.128 the pell center for international relations and public policy, which authored a report on cybersecurity issues, came to the conclusion that a lack of cyber-education within congress was largely responsible for why more has not been done to provide cybersecurity assistance, stating: most legislators are poorly educated on these issues and very few have taken the time to understand how this helps a state economically or from a security standpoint . . . [w]e see the same issues in state legislatures that we see in the u.s. congress. although it is a bipartisan issue, the reason so many cybersecurity bills are stalling in congress comes down to those who have taken the time to educate themselves and those who haven’t.129 this lack of education has effectively meant that congress only acts when a major cyberattack is in the public spotlight, something that led the executive director of the national association of state chief information officers to remark that, “[i]t often takes a data breach for lawmakers to pass significant legislation around cybersecurity. . . .”130 the high-profile nature and large volume of ransomware attacks, as well as other major cybersecurity breaches, in both the united states and abroad has helped provide more long-standing attention to the situation. this is something that industry analysts hope will prompt congress to take more action: you always want to take advantage of somebody else’s breach to educate. it does bring home the fact that you either invest in front of the problem or you are investing by trying to clean up at the back end of the problem. it is a tough job to find out where that balance is. it is important to me that we don’t spend our tax dollars cleaning up something that could have been avoided.131 in 2015, congress established a temporary cybersecurity task force to consult on cybersecurity threats facing the healthcare industry, which it began working on in 2016.132 the task force reported on its findings to congress in june of major-cyber-bill-in-years [https://perma.cc/g45u-2j5d]; see also sean lyngaas, with ransomware on the rise, senate botnet bill gets another shot, fcw (may 19, 2016), https://fcw.com/articles/ 2016/05/19/botnet-whitehouse-bill.aspx [https://perma.cc/7zsk-cblc]. 128. david raths, legislating cybersecurity: breaches grab lawmakers’ attention, government tech. (oct. 12, 2016), http://www.govtech.com/security/legislating-cybersecuritybreaches-grab-lawmakers-attention.html [https://perma.cc/m6d5-rzfy]. 129. id. 130. id. 131. id. 132. health care industry cybersecurity task force, u.s. dep’t of health & human servs. (last viewed feb. 10, 2017), https://www.phe.gov/preparedness/planning/cybertf/ pages/default.aspx [https://perma.cc/cxc8-svsu]. 2018] once more unto the breach 323 2017.133 2. the healthcare industry thus far, most of the healthcare industry, particularly in the legal field, has largely focused on helping that covered entities comply with the hipaa-based ransomware guidance recommended by hhs.134 part of this awareness and stress for hipaa compliance comes from the potential punishments: covered entities are now effectively on notice that failure to take reasonable precautions to prevent ransomware will lead to hipaa penalties.135 outside of these actions, there are no perceptible changes being done within most covered entities to upgrade their cybersecurity systems, and continued ransomware attacks seem to indicate that this will be a growing problem until fundamental changes are made. b. problems with the hhs response the hhs guidelines certainly illuminate its thoughts on why it has categorized ransomware as causing breaches, and gives covered entities some guidance on how to proceed in the immediate future; however, even with the hhs guidelines and recommendations designed to help hospitals shore up their security systems, current ransomware trends indicate that complying with hipaa will not be enough to thwart future ransomware attacks in the coming years. for one, ransomware software is becoming more and more sophisticated to get around the hhs recommendations regarding “phishing” tactics, or attacks that ask for your personal information.136 for example, a variant of ransomware known as “locky” disguises itself as an email claiming to carry a legitimate office invoice.137 newer variants of ransomware are now being found that target network backups, further negating current strategies to keep an online backup.138 some variants no longer even require an individual to open up a malicious email; ransomware can now be seeded into legitimate websites and take advantage of unpatched software.139 even if a covered entity’s personnel are trained against clicking on suspicious links, there is always the threat that a hacker can access a 133. health care indus. cyberecurity task force, rep. on improving cybersecurity in the health care indus. (2017). 134. see generally hhs issues new guidance on ransomware, ropes & grey (july 19, 2016), https://www.ropesgray.com/newsroom/alerts/2016/july/hhs-issues-new-guidance-onransomware.aspx [https://perma.cc/6xab-qtje] (providing an example of a law firm explaining how covered entities need to treat hhs ransomware guidance). 135. elizabeth snell, hipaa data breaches: what covered entities must know, health it security, http://healthitsecurity.com/features/hipaa-data-breaches-what-covered-entities-mustknow [https://perma.cc/m5md-rvv5] (last visited nov. 5, 2016). 136. fed. trade commission, consumer information: phishing, https://www.consumer. ftc.gov/articles/0003-phishing [https://perma.cc/mfb3-dm2n] (last updated july 2017). 137. zetter, supra note 21. 138. id. 139. fed. bureau of investigation, supra note 46. 324 indiana health law review [vol. 15:305 covered entity’s network through a jump-drive.140 in a recent dhs test, staffers discreetly dropped computer disks and jump drives in various government buildings and parking lots; 60% of those items ended up being plugged into government computers, and the percentage rose to almost 90% when those items had an official logo.141 even the best network defenses can fall prey to human error. secondly, covered entities, specifically hospitals, are already notoriously behind the times in terms of their technology and cybersecurity. hospitals are largely still wired with unprotected wireless access and outdated computer operating systems, which facilitate easy attacks by hackers.142 the plethora of medical devices within a hospital that are largely unprotected also grant an access point to external attackers.143 in essence, a covered entity simply has too many holes in its cybersecurity defenses to effectively cover all of them. even if a covered entity goes above and beyond in complying with hipaa and fully and appropriately encrypts its data, this is no guarantee that a covered entity can presume that there was no breach. the health and human services guidelines themselves serve to indicate that point, stating: because [decryption occurred] and thus [became] “unsecured phi” at the point in time that the ransomware accessed the file, an impermissible disclosure of phi was made and a breach is presumed. under the hipaa breach notification rule, notification in accordance with 45 cfr 164.404 is required unless the entity can demonstrate a low probability of compromise of the phi based on the four-factor risk assessment.144 this proclamation from hhs serves to indicate that even if a covered entity has taken every foreseeable means to protect its data from a ransomware attack, if an attack does occur and successfully overwrites the cybersecurity encryptions of a covered entity’s phi, then a breach has still occurred and will be presumed unless the covered entity in question can prove otherwise. as ransomware overwrites any data encryption with its own encryption,145 this scenario effectively applies to every situation involving ransomware and thus will always mean that a covered entity must conduct a risk assessment. while this policy is very patient-friendly and leans on the side of protecting the health information of the public, it simultaneously creates an unattainable standard for covered entities, 140. siwicki, supra note 41. 141. id; see also lisa vaas, hospitals vulnerable to cyber attacks on just about everything, naked security by sophos (feb. 26, 2016), https://nakedsecurity.sophos.com/2016/02/26/ hospitals-vulnerable-to-cyber-attacks-on-just-about-everything/ [https://perma.cc/xhe6-f644] (describing a similar test involving healthcare facilities). 142. cybersecurity in the healthcare industry, infosec institute (may 23, 2016), h t tp:/ / resources. in fosec in s t i t u t e . com /cybersecurity-in -the-healthcare-industry/ [https://perma.cc/b67v-j5z9]. 143. id. 144. u.s. dep’t. of health & human servs., supra note 4. 145. id. 2018] once more unto the breach 325 who will always be open to financial penalties under hipaa should a breach occur in spite of any efforts taken to go beyond what hipaa currently stipulates. in effect, it indirectly creates a disincentive to strengthen cybersecurity. in addition to the technical difficulties encountered by covered entities, the current hhs position that ransomware is a breach creates too many loopholes for covered entities to avoid reporting breaches, potentially leading to underreporting of an issue that affects every american. the aforementioned four factors that hhs determined must be met in order for a covered entity to determine that no breach had occurred are essential in this task. those four factors are: (1) the nature and extent of the phi involved, including the types of identifiers and the likelihood of re-identification; (2) the unauthorized person who used the phi or to whom the disclosure was made; (3) whether the phi was actually acquired or viewed; and (4) the extent to which the risk to the phi has been mitigated.146 however, hhs has also declared that there are other exceptions to the breach rule, most importantly the “good faith belief” exception. “the final exception applies if the covered entity or business associate has a good faith belief that the unauthorized person to whom the impermissible disclosure was made, would not have been able to retain the information.”147 determining which of the hundreds of variants of ransomware a covered entity was hit by–and consequently whether or not the lost data was actually viewed by a third party–might not be realistic to do. this in turn might incentivize covered entities to claim that there was no breach based on good-faith belief, which would enable them to avoid opening themselves up to hipaa fines and penalties for failure to prevent a breach.148 determining the exact variant of ransomware one is dealing with can be close to impossible; malware data analysis has found and evaluated over a million unique variants of ransomware.149 in essence, if the variant in question does not exfiltrate data, covered entities might instead chose not to report it because no data has actually been lost.150 finally, a successful attack might require a covered entity to pay the ransom in order to protect the health and safety of patients. current policy opens up covered entities to financial penalties under hipaa whenever there is a breach, regardless of whether or not the covered entity pays the ransom or not, and so does not properly act as a deterrent for payment nor provide incentive to upgrade a covered entity’s cybersecurity.151 while the financial penalties alone provide incentive for covered entities to comply with hipaa in ordinary circumstances, 146. 45 c.f.r. § 164.402(2). 147. u.s. dep’t of health & human servs., supra note 82. 148. hipaa j., supra note 85. 149. mellen, supra note 7. 150. id. 151. see generally; hipaa j., supra note 85. 326 indiana health law review [vol. 15:305 ransomware is far from ordinary; the fact that lives are potentially at stake, in conjunction with the knowledge that a penalty is likely forthcoming regardless of whether or not the covered entity does in fact pay, must be taken into account when a covered entity succumbs to the pressure to pay for the return of its information.152 these outcomes serve to render the current guidelines set by hhs wholly inadequate. the guidelines must be changed if ransomware attacks are to be mitigated or stopped outright. the solution to the problems imposed by ransomware must take into account both the technical laxness of covered entities, the problems with current hipaa legislation in regards to ransomware, and the necessity by covered entities to ensure that they are able to meet the needs of their patients. c. solutions to better deal with ransomware 1. solution 1: draft new legislation that directly addresses ransomware even though hhs has now provided key guidance in how covered entities should approach ransomware attacks, it has also created a cumbersome, subjective, and fact-specific determination that does not incentivize covered entities to report attacks.153 congressmen have already acknowledged that ransomware does not fit into the typical definition of a breach.154 congressman ted lieu summed up the paradoxical nature of combating ransomware in an open letter to hhs, stating: however, just because a ransomware attack qualifies as a conventional breach, that does not mean they should be treated the same or subject to the exact same risk assessment . . . in a normal breach, personal health information is either viewed or stolen, infringing the privacy rights of the patient. ransomware, however, denies access to health records or information technology functions that enable the provider to offer health care services.155 any future legislation must deal with the unusual paradox posed by ransomware. therefore, the most immediate solution to dealing with the factspecific ambiguity of whether a ransomware attack constitutes a breach of phi or not is to pass new or updated legislation explicitly making ransomware, regardless of the outcome or facts, to be a reportable event rather than a normal hipaa breach. in essence, while ransomware attacks would still have to be reported by covered entities when they occur, they would not automatically open up said entity to financial penalties under hipaa, and if necessary the disclosure could be private, so as not to alert potential attackers from making additional attempts. 152. snell, supra note 67. 153. u.s. dep’t. of health & human servs., supra note 4. 154. lieu, supra note 68. 155. id. 2018] once more unto the breach 327 such a law would have to strike a careful balance between the interest of patients in ensuring that their data has been secured and the interest of covered entities in ensuring that they are not unduly penalized for ransomware attacks.156 hhs should still have the power to levy fines against egregious failures to comply with hipaa security rules, but that would be the exception and not the rule for reporting ransomware. fines should only be levied when a covered entity has egregiously failed to protect its electronic phi by not properly upgrading their cybersecurity or as a result of catastrophic human error. this would encourage reporting among covered entities and give agencies such as the fbi or the dhs a clearer picture of how widespread the threat of ransomware is. there has already been a strong push in congress to pass sweeping healthcare cybersecurity legislation as more and more cyberattacks have occurred over the year.157 by separating ransomware and its ilk into its own class of cyberattack, congress can make it far more palatable for covered entities to report attacks. 2. solution 2: empower hhs to explicitly deal with ransomware as noted above, congress has had difficulty passing cybersecurity legislation because many of its members have difficulty understanding the complexities of the cyber-world.158 a simple way to avoid any undue delay in protecting critical cyber-infrastructure would be for congress to further empower hhs to deal with cybersecurity requirements, delegating some of their legislative power to that effect. hhs already has a cybersecurity task force in place to work with dhs and national institutes of science and technology to analyze and review the threats facing the healthcare industry and strategies other industries have implemented to deter attacks.159 however, afterwards, the task force only reports their findings to the secretary of health and human services and congress and does not directly create regulations itself, as its mandate will end in march of 2017.160 with such a broad array of experts from both the public and private sectors already assembled, it would make logical sense for congress to extend the task force’s mandate and expand its regulatory power. while its findings would certainly assist congress in creating legislation, by extending the mandate of the cybersecurity task force and granting further regulatory power to health and human services, the us government will be able to better respond to not only ransomware, but to current and future cybersecurity threats that could threaten the healthcare system. current congressional legislative attempts to curb ransomware may fail to account for the exponential growth and threat ransomware can pose, and ransomware is constantly evolving, which may thwart current congressional efforts in unexpected ways.161 members of dhs have already estimated that 156. hipaa j., supra note 85. 157. raths, supra note 128. 158. id. 159. u.s. dep’t of health & human servs., supra note 132. 160. id. 161. see generally tom spring, meet the cryptoworm, the future of ransomware, 328 indiana health law review [vol. 15:305 ransomware could soon start to threaten patient medical devices.162 for legislation and regulations to keep up with the pace of cyberthreats, it is necessary for congress to establish a permanent cybersecurity task force and grant it regulatory power. 3. solution 3: create financial incentives for covered entities to better secure their data the other side of this coin is ensuring that covered entities have better cybersecurity functions, so as to either thwart attacks or present such an unprofitable target as to deter future attackers. to best ensure such an outcome, congress could help by providing financial incentives to covered entities to update and upgrade their cybersecurity systems. congress has used similar means in the past to provide incentive for the healthcare industry to adopt new technologies; the hitech act, for example, provided financial incentives to encourage the adoption of electronic health records (ehr).163 for hitting certain benchmarks in its usage of electronic health records, the government provided incentive payments to hospitals and other healthcare entities in the form of increased funding to medicaid programs; as the program continued to grow, the government later began to levy financial penalties on hospitals and other healthcare systems that were not following suit with the early adopters.164 hhs has reported that it has seen a significant increase in the adoption and use of health it systems among providers and the new data shows the importance of incentives in building an interoperable health it system.165 these incentives have also led to widespread adoption of electronic health records across the united states, and hhs has further noted that “[s]ince the enactment of hitech in 2009, 62 percent of physicians who adopted health it tools identified financial incentives and penalties as a major influence on their decision to adopt, compared threatpost (apr. 12, 2016), https://threatpost.com/meet-the-cryptoworm-the-future-ofransomware/117330/ (discussing the potential next threat ransomware may take in 2017) [https://perma.cc/a8cf-tkx7]. 162. greg slabodkin, supra note 24. 163. financial incentives and ability to exchange clinical information found to be top reasons for ehr adoption, u.s. dep’t. of health & human servs. (dec. 5, 2014), https://wayback.archive-it.org/3926/20170128122615/https://www.hhs.gov/about/news/2014/12/ 05/financial-incentives-and-ability-exchange-clinical-information-found-be-top-reasons-for-ehradoption [https://perma.cc/zb4v-6zcs]. 164. electronic health records (ehr) incentive programs, centers for medicare & medicaid servs. (last modified feb. 8, 2017), https://wayback.archive-it.org/3926/ 20170127160700/h t tps:/ /www.cms.gov/regulat ions-and-guidance/legislat ion / ehrincentiveprograms/index.html?redirect=/ehrincentiveprograms [https://perma.cc/9m9xv6gl]. 165. financial incentives and ability to exchange clinical information found to be top reasons for ehr adoption, u.s. dep’t. of health & human servs. (dec. 5, 2014), https://wayback.archive-it.org/3926/20170128122615/https://www.hhs.gov/about/news/2014/12/05/ financial-incentives-and-ability-exchange-clinical-information-found-be-top-reasons-for-ehradoption [https://perma.cc/zb4v-6zcs]. 2018] once more unto the breach 329 with only 23 percent of physicians who adopted before 2009.”166 the u.s. government has already taken steps to provide federally funded cybersecurity education to covered entities; in 2016, hhs invested $250,000 in creating an information sharing and analysis organization, designed to facilitate information-sharing in the healthcare and public health sectors on current cyber threats, increase general cybersecurity awareness, and begin equipping stakeholders to respond to the information they are provided.167 while this is a good start to better equip the healthcare sector for cyber threats, covered entities will require more incentives in order to undergo fundamental cybersecurity upgrades. similar financial incentives to the hitech act, like providing increased federal funding to it programs within covered entities, providing more funding for traditional healthcare programs such as medicare or medicaid, or even by providing a tax write-off for some or all of the costs incurred by entities attempting to upgrade their cybersecurity systems, combined with the fear of experiencing a ransomware attack, have a strong likelihood of pushing hospitals and other healthcare providers into truly strengthening their cybersecurity systems. iii. conclusion ransomware presents an unusually paradoxical threat to the united states’ healthcare industry. while it does not seize data in the traditional manner that cybersecurity threats have typically gone after electronic phi, it has found a new way to hurt patient safety and care by restricting much-needed access to those files. a focus on hipaa compliance, rather than cutting-edge cybersecurity, has left the healthcare industry critically exposed to the dangers wrought by ransomware attacks. however, as devastating as ransomware attacks have been to the healthcare industry over the past two years, they have also brought a much-needed spotlight to the threat ransomware and other cybersecurity threats pose to both the protection of patient health information and the healthcare infrastructure of the united states. fundamental change is going to be required if we are to protect our health information. the guidance issued by hhs offers a solid stopgap measure and a foundation for change, but it is not enough. ransomware attacks on the healthcare industry will markedly decrease only when legislation that mandates ransomware as a reportable event while simultaneously providing financial incentives for hospitals 166. id. 167. akanksha jayanthi, hhs to fund cybersecurity information sharing organization, health it & cio review (july 26, 2016), http://www.beckershospitalreview.com/healthcarein f o r m a t io n t e c h n o lo g y/ h h s t o f u n d c y b e r s e c u r i t y in f o r m a t io n s h a r in g organization.html[https://perma.cc/ns96-smjz]. 330 indiana health law review [vol. 15:305 to improve their cybersecurity suites. it will take some time for these changes to be implemented, but the sooner congress takes action, the sooner the dreaded specter of ransomware will cease to be a critical threat to the health infrastructure of the united states. justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 samantha j. weichert i. introduction ............................................................... 273 a. the history of organ donation ................................ 273 ii. organ donation in prison systems ......................... 277 a. rights of regular inmates ........................................ 277 b. rights of death row inmates ................................... 280 iii. challenges of passing a bill ................................. 284 a. stigma ....................................................................... 284 b. a physician’s role ..................................................... 287 c. the lethal injection process .................................... 289 d. jury deliberations .................................................... 291 iv. padfield and house bill 41 – a history of pushing for procurement .............................................. 294 a. what happened? ........................................................ 294 b. no legislation since bill 41 in indiana .................... 295 v. overcoming challenges ............................................ 295 a. changing the role of physicians in executions ....... 295 1. exploring the case of brittany maynard .............. 296 2. oregon’s death with dignity act and the hippocratic oath…………………………………… ....... 298 b. changing the nature of lethal injection .................. 304 c. bill reintroduction is a necessity ............................. 307 * j.d. candidate, may 2016, indiana university robert h. mckinney school of law; b.a., 2013, butler university. http://dx.doi.org/10.18060/3911.0017 2016 273 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 i. introduction somewhere in our country a young child is dying in a hospital bed. wires cover her body and the monotonous pang of a heart monitor fills the air. next door, a young man hobbles out of bed. he makes it far enough to look out of his room’s window. each day, for each of these patients, is a gift– for each day is not a given. each patient faces a similar fate. living on the organ waiting list has its travails. it is unlikely that either patient will ever be a recipient. and yet still, somewhere else in our country, two men are exact biological matches for these two patients. they want to donate. they have the medical requisites. however, they are disallowed from doing so. they cannot save the lives of these two patients. this story’s conclusion is an unfortunate one, for at the end, both the patients and the willing donors die. should the patients’ lives have been saved? should the men have been allowed to donate? this cold injustice has happened and will continue to happen. however, what if you were told that these two men, the potential donors, were death row inmates? would that change the injustice of the story? would that change the weight of the patients’ needs? would that change the value of a decision to donate? this is the battle that indiana’s legislative system needs to fight. we need to change the ending to this story. and we can. we can allow death row inmates to donate their organs. by allowing this, not only could we proactively combat the organ shortage but we could also preserve the biological autonomy of those condemned to die. a. the history of organ donation organ donation may seem like a phenomenon brought on only by the recent breakthroughs of the medical community within the last few decades. however, organ donation and transplantation date back to the 18th century when researchers experimented with transplantation on both 274 indiana health law review vol. 13:1 humans and animals.1 since then, the evolution of medicine has come a long way. now more and more tissues and organs are available to be recycled to save lives. anatomically, the organs and tissues available to be used in transplantations are numerous. currently, “[t]he human body has approximately twenty-five transplantable parts, including the heart, nerves, skin, bone marrow, the liver, kidneys, corneas, glands, blood vessels, and tendons.”2 and yet, just because the body has so many different parts that can be donated, does not necessarily mean that, by default, these organs are in fact given to those in need. nonetheless, science has progressed to allow for this possibility. as such, the organ donation process has become quite simplistic. transplantation surgeries are now more common than ever before. in 1869 the first skin transplant was performed.3 years later, doctors were able to successfully transplant a cornea.4 even later, the first successful transplant of a kidney was performed in 1954.5 this was an immense breakthrough. the transplantation of an entire organ, like a kidney, meant that more vital and complex parts of the human body had the potential to be recycled as long as they remained functional. biological science was making leaps and bounds in the mid 1900s with these new technologies that allowed people to both donate and to receive life-saving organs and parts. 1 history, organ procurement and transplantation network, u.s. dept. of health and human serv., http://optn.transplant.hrsa.gov/ learn/about-transplantation/history/ [http://perma.cc/7b44-9q5x ](last visited nov. 20, 2015). 2 laura-hill m. patton, a call for common sense: organ donation and the executed prisoner, 3 va. j. soc. pol’y & l. 387, 388 (1996) (citing to lloyd r. cohen, increasing the supply of transplant organs: the virtues of a futures market, 58 geo. wash. l. rev. 1, 3 (1989)). 3 timeline of historical events significant milestones in organ donation and transplantation, organdonor.gov, http:// www.organdonor.gov/legislation/timeline.html [http://perma.cc/9chvmlha] (last visited oct. 7, 2015). 4 id. 5 history, united network for organ sharing, https:// www.unos.org/transplantation/history/ [http://perma.cc/48kj-qa8h] (last visited oct. 7, 2015). 2016 275 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 thus, due to the increase in the use of these procedures, “the national organ transplant association (nota) [in 1984], called for an organ procurement and transplantation network (optn).”6 optn was to be managed by a private, non-profit group.7 doctors and patients alike could rely on this independent governing body to facilitate each of their needs. organ donation, in practice and in procedure, was rapidly evolving and becoming a highly regulated and structured endeavor. nearly forty years after the first organ transplantation surgery, the first living-donor and living-recipient organ donation procedure was performed in 1998.8 by 2001, there were more living donors than deceased: 6,5281living donors as compared to 6,081 deceased donors. 9 this accomplishment allowed the surplus living donors to achieve a valuable position in the organ donation hierarchy. after successes in dead-donor operations, doctors began conducting procedures involving more essential, non-selfrenewing organs. 10 in one documented case involving a living donor, “dr. joseph e. murray successfully transplanted a healthy kidney from ronald herrick to mr. herrick's identical twin richard, who had been diagnosed with end-stage kidney failure.”11 richard lived many years longer following the life-saving transplant, before suffering a heart attack and dying.12 after dr. murray’s successful kidney transplant procedure, the realm of biological science and operative medicine had been forever changed. to keep pace with the growing evolution of organ transplantation, even more regulation was needed. today, the uniform anatomical gift 6 id. 7 id. 8 id. 9 id. 10 kelly ann keller, the bed of life: a discussion of organ donation, its legal and scientific history, and a recommended “opt-out” solution to organ scarcity, 32 stetson l. rev. 855, 865-66 (2003). 11 id. 12 id. 276 indiana health law review vol. 13:1 act (uaga), the united network for organ sharing (unos), and the national organ transplant act (nota) all serve as entities that regulate various transplant and donation procedures, established to coordinate and regulate organ transplantation. the uaga was established in 1968. 13 this act established protocol that allowed for donation via documented gifts. 14 the act “deemed a person's legal consent to donate before death sufficient under the law . . . .”15 thus, uaga allowed the law to catch up with science. however, despite the breakthroughs in science and the legal underpinnings that proved to be quite simple, a deficit was created. as of january 31, 2016, there were 121,579 individuals waiting for an organ transplant.16 someone is added to the organ wait list every 10 minutes.17 and, although seventy-nine people receive organ transplants each day, 18 on average, it is estimated that twenty-two people die waiting for an organ everyday.19 for those lucky enough to be placed on a waiting list, the process is highly and thoroughly systematic. through the unos organ center, organ donors are matched to waiting recipients all day, every day throughout the year.20 “when an organ becomes available, the local organ procurement 13 selected statutory and regulatory history of organ transplantation, organdonor.gov, http://www.organdonor.gov/ legislation/legislationhistory.html [http://perma.cc/5q2m-9pj2] (last visited nov. 16, 2015). 14 id. 15 id. 16 data, organ procurement and transplantation network, http://optn.transplant.hrsa.gov/converge/data/ [https://perma.cc/rx7enlls] (last visited jan. 31, 2016). 17 the need is real: data, organdonor.gov, http:// www.organdonor.gov/about/data.html [http://perma.cc/8pdc-2ndb] (last visited nov. 16, 2015). 18 id. 19 id. 20 united network for organ sharing, https://www.unos.org [http://perma.cc/p359-amza] (last visited oct. 8, 2015). 2016 277 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 organization (opo) sends medical and genetic information to unos.” 21 unos then generates a list of potential recipients.22 the organ is first offered to the candidate who is the best match.23 organs are distributed locally first, and if no match is found, they are offered regionally and then nationally.24 though there are thousands on the waiting list, many of those people could be helped or saved by just a few donors. “experts say that the organs from one [person] can save or help as many as [fifty] people.”25 with a few simple steps, it’s easy to become a donor. all it takes is signing up for a state’s donor registry. even when updating one’s identification at the dmv, a simple “yes” answer would allow an individual to become a donor. however, despite the seemingly simple processes, not all people are given the right to donate in its entirety. ii. organ donation in prison systems a. rights of regular inmates many are unaware that even in light of the huge demand for organs and tissues, not all people are afforded the right to donate. many cannot participate in live donations and even more striking, others may not be allowed to donate upon death. these people are our nation’s death-row prisoners. many states oppose the idea of allowing condemned prisoner organ donation considering the high-risk population 21 organ transplantation, cleveland clinic: treatment and procedures, https://my.clevelandclinic.org/health/treatments_and_ procedures/hic_organ_donation_and_transplantation [https://perma.cc/ 5kvp-bt5v] (last visited nov. 24, 2015). 22 id. 23 how organs are matched, united network for organ sharing, https://www.unos.org/transplantation/matching-organs/ [http://perma.cc/ 3urr-f84y] (last visited oct. 8, 2015). 24 id. 25 organ donation, u.s. nat’l libr. of med., http:// www.nlm.nih.gov/medlineplus/organdonation.html [http://perma.cc/ ug3z-7kgk] (last updated oct. 2, 2015). 278 indiana health law review vol. 13:1 that comprises prisons in the united states.26 since the 1990s, health-related risks have prevented inmates from being able to donate their organs.27 however, in arizona’s maricopa county, as of 2007, there is a program to allow inmates to donate only certain organs.28 nevertheless, for death row inmates, the official position of unos currently is that until the ethical and legal barriers of condemned prisoner organ donation are overcome, no support can be lent to the movement.29 and yet, in spite of unos’s stance, arizona’s prison organ donation program has proven to be quite effective. 30 in arizona, when criminals are booked into prison, they are given the opportunity to register to be an organ donor.31 26 see lawrence o. gostin, prisoners shouldn’t be allowed to donate their organs, n.y. times (april 26, 2013, 1:18 pm), http:// www.nytimes.com/roomfordebate/2013/04/25/should-prisoners-beallowed-to-donate-their-organs/prisoners-shouldnt-be-allowed-to-donatetheir-organs [https://perma.cc/jpe3-dhry]. 27 martha f. rogers et al., guidelines for preventing transmission of human immunodeficiency virus through transplantation of human tissue and organs, cdc (may 20, 1994), http://www.cdc.gov/ mmwr/preview/mmwrhtml/00031670.htm [http://perma.cc/w2cyhjta]. 28 shannon ross, with organ donations, let prisoners give life to others, n.y. times (apr. 25, 2013), http://www.nytimes.com/ roomfordebate/2013/04/25/should-prisoners-be-allowed-to-donate-theirorgans/with-organ-donations-let-prisoners-give-life-to-others [http:// perma.cc/38bk-4tug]. see also joe arpaio, arpaio’s ‘i do’ program (inmates willing to donate their organs) has them joining national drive, maricopa county news release (apr. 29, 2015) available at http://www.mcso.org/multimedia/pressrelease/organ%20donor.pdf [https://perma.cc/78vh-9g34]. 29 the ethics of organ donation from condemned prisoners, u.s. dep’t of health & human serv., http://optn.transplant.hrsa.gov/ resources/ethics/the-ethics-of-organ-donation-from-condemnedprisoners/ [http://perma.cc/5gwh-3vg5] (last visited oct. 8, 2015). 30 arpaio, supra note 28. 31 kate bennion, kidneys from felons? prisoner organ donation spurs debate, deseret news (april 24, 2013, 11:05 am), http:// www.deseretnews.com/article/865578852/kidneys-from-felons-prisonerorgan-donation-spurs-debate.html?pg=all [http://perma.cc/b2n44qhm]. 2016 279 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 somewhere between frisking and fingerprinting, those who opt in are given access to the state donor registry site . . . . as of [january] 28 of [2013], the office has registered 14,124 inmates for the state organ donor program. those booked into the county jail are pre-sentence and pre-trial detainees or sentenced to a year or less. if they [a]re released, they are no longer considered by the organ registry to be at high risk for health complications – and remain on the state organ donor registry.32 one must keep in mind though, that the various programs that are offered to allow inmates to donate their organs are conditioned upon death within the prison system. many politicians, lawmakers, and ethicists struggle in grappling with the idea of allowing living prisoners to donate non-vital organs like kidneys. the potential risks of coercion, undue persuasion, or even compensation for a decreased prison sentence are worrisome. as an example, “[i]n january 2011, mississippi governor haley barbour freed two sisters from life sentences . . . on the condition that one donate a kidney to the other.” 33 governor barbour granted parole to gladys scott on the condition that she become a donor for her sister, jamie scott, who needed a kidney transplant in order to survive without the imposition of dialysis treatment.34 barbour claimed that his reasoning was based in part on the financial burden of jamie scott’s kidney dialysis treatment on the state. 35 despite the arguably unethical underpinnings of these orders, one must ask how this can be tolerated over death row organ donation, where there may be no coercion or unethical persuasion at play. similar to governor barbour’s order, other state legislators have proposed bills that would shorten sentences 32 id. 33 arthur caplan, the use of prisoners as sources of organs – an ethically dubious practice, 11 am. j. of bioethics 1, 1 (2011), available at http://ldihealtheconomist.com/media/caplan_prisoners_organs.pdf [https://perma.cc/tp72-xuzb]. 34 id. 35 id. http://dx.doi.org/10.1080/15265161.2011.607397 280 indiana health law review vol. 13:1 for inmates who choose to donate organs.36 in 2007, a law was proposed in south carolina that would shorten prison sentences in exchange for kidney or bone marrow donation.37 further, south carolina “state senator ralph anderson proposed bills that would release prisoners [sixty] days early . . . .”38 one bill gave early release for those who donated bone marrow and the other gave “good-behavior credit of up to 180 days, ‘to any inmate who perform[ed] a particularly meritorious or humanitarian act [] includ[ing] living kidney donation.’”39 regulations such as these are completely unethical because they function as bribes. these ethical pitfalls are not givens, and they are not necessarily fundamental to how death row inmate donation could work. realistically, for condemned prisoners, unlike regular inmates, there is no incentive to be had. and so, without any indication of incentivized conditions, even those who wish to be wholly and truly altruistic nonetheless cannot. b. rights of death row inmates utah, in 2013, became the first state to allow any inmate to donate his organs if he were to die while incarcerated.40 this law, while a major breakthrough in the realm of bioethics and the law, still leaves much to be done in other states to follow suit. although strides such as utah’s law have been made to allow prisoners to donate, death row inmates in indiana, and across the nation, are still disallowed access to one of life’s most noble deeds. they are denied the right to donate organs, whether during their lives or upon their deaths. this issue has spurred debate over what rights death row inmates actually possess. some believe that due to their incarceration, prisoners have no rights–not even to their 36 id. 37 id. at 1-2. 38 id. at 1. 39 id. at 2 (citation omitted). 40 utah code ann. 1953 § 64-13-44 (2013). 2016 281 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 bodies. others believe that allowing our nation’s worst criminals to become organ donors, would detract from the retributive nature of the death penalty itself. in other words, if death is the punishment, any act of altruism or act of purification (in this case organ donation) would seemingly purge the sentence of its inherent severity. others may believe the stigma of inmate-donated organs cannot be overcome, or that organs acquired from prisoners are too risky. that is, there may be too many health concerns. and yet, despite these concerns, many states have proposed legislation to allow death row inmates to donate their organs. however, these bills have not survived the wide criticism they encounter. in 2000, florida state representative william f. andrews introduced florida house bill 999 entitled “an act relating to anatomical gifts by capital defendants.”41 this bill, like many of its predecessors and progeny, would have permitted condemned prisoners to donate their organs following their executions. 42 however, this bill saw huge opposition from all facets of the community.43 in 1984, california tried to pass a similar bill, which would have provided for organ donation from death row inmates.44 however, this bill failed to be introduced due to huge opposition and distaste for the idea.45 arizona also tried to allow death row inmates to donate their organs. 46 there, representative bill mcgibbon proposed a system that would allow inmates to have a choice in the method of execution–one where their organs could be harvested and another where a lethal injection was used.47 however, like the others, the bill did not pass.48 41 whitney hinkle, giving until it hurts: prisoners are not the answer to the national organ shortage, ind. l. rev. 593, 599 (2002). 42 id. 43 id. 44 patton, supra note 2, at 432. 45 id. 46 id. 47 hinkle, supra note 41, at 600. 48 id. 282 indiana health law review vol. 13:1 concerning indiana most, though, is the case that began the state’s legislative drive to allow death row inmates to donate their organs.49 gregory scott johnson, a death row inmate who catalyzed the controversy, was sent to prison and sentenced to death for the murder of an 82-year-old woman.50 on may 25, 2005, the headline of an article in the indianapolis star read: “[s]tate executes killer who wanted to donate liver.” 51 johnson had fervently petitioned for clemency in order to become an organ donor. 52 on the tuesday before johnson’s execution, governor mitch daniels rejected johnson’s plea for clemency, which was to determine if he could donate a portion of his liver to his dying sister.53 the indiana parole board did not believe that johnson truly wanted to help his sister.54 then, just twelve hours before johnson was scheduled to die, governor mitch daniels denied a final clemency plea stating that he “found no reasonable grounds to spare johnson’s life.”55 one of the reasons that the indiana parole board denied johnson’s request was due in part to the response from the greater indiana physician network.56 the network advised the parole board “that they did not want to jeopardize [the transplant center’s] compliance with guidelines set by the united network for organ sharing, which has a ‘clear position against allowing condemned prisoners to donate organs.’”57 further, governor daniels was informed by the medical community that johnson, regardless of his status as a 49 johnson v. state, 584 n.e.2d 1092 (ind. 1992). 50 id. at 1096-97. 51 vic ryckaert & kevin corcoran, state executes killer who wanted to donate liver; gregory scott johnson is 3rd inmate indiana has put to death this year, indianapolis star (may 25, 2005) available at http://www.clarkprosecutor.org/html/death/us/johnson970.htm [http://perma.cc/hwm8-8evn]. 52 id. 53 id. 54 id. 55 id. 56 id. 57 id. 2016 283 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 condemned prisoner, was an unsuitable donor.58 the doctors stated that there was “the presence of a hepatitis b antibody in johnson’s system.” 59 this antibody, in addition to johnson’s obesity, rendered him an unsuitable donor.60 despite its setbacks and final result, this case raised the question in indiana concerning the morality of condemned prisoner organ donation. had johnson been a suitable candidate, would it have been likely that he would have been granted a stay in order to harvest a portion of his liver to save his dying sister? based on the medical community’s outcry and their strict deference to the standards set by unos, it is unlikely. further, judging from other states’ failures in their bill passage initiatives, it is unlikely that a stay for johnson would have been granted. in fact, prior to johnson’s execution, a bill was proposed by indiana state representative jon padfield that would have allowed johnson to donate. 61 “[r]epresentative padfield introduced a resolution in 1995 urging indiana’s legislative council to [create a committee to] consider organ [extraction] from condemned prisoners.”62 the bill called “for a study of execution methods that do not destroy human organs.”63 the bill did not pass.64 since then, no bill in indiana has had full support from the legal, political, or medical community–the kind of support required to prevail. it would appear then that indiana’s status is much like that of other states across the country. it will not be until key bioethical dilemmas and legal hurdles are overcome that the state will be able to pursue a bill like this again. until a padfield-like bill is passed, our nation’s organ shortage may only grow larger as this population of willing donors is continually denied access to saving lives. 58 id. 59 id. 60 id. 61 h. res. 41, 109th leg., 1st sess. (ind. 1995) reprinted in state of indiana, journal of the house of representatives, 109th general assembly, first regular session, at 1111 (1995). 62 hinkle, supra note 41 at 599-600 (citation omitted). 63 id. at 600 n.44. 64 id. at 599. 284 indiana health law review vol. 13:1 iii. challenges of passing a bill a. stigma the first place to start in gaining speed with a bill allowing for condemned prisoner organ donation would be to overcome the stigma attached to prisoners–and even more so, to death row prisoners. there is no question that incarcerated individuals are stigmatized, that is, they are stereotyped and deemed to be members of an overall distasteful group. studies have shown that the public’s thoughts and perceptions regarding inmates are generally quite negative.65 it is not hard to imagine then, given that inmates exist as reflections of society’s stigma, that there would be some hesitation with combining a part of an inmate’s body with the body of a non-criminal member of society. this is all to say that some individuals may not like the idea of having a criminal’s organs used within the organ transplantation network. it could be that many do not value the lives of inmates and view organ donation as a perversion of the qualities of retributive justice.66 given the past acts of these condemned prisoners, most of whom are guilty of society’s most heinous crimes, many may feel repulsed by the idea of the potential to somehow be biologically “linked” to them. as dr. david orentlicher, professor of law at robert h. mckinney school of law states in a piece done by the new york times, “people might say, ‘gosh i’m walking around with the organ of a murderer,” – that is, some individuals 65 kelly moore, et. al., jail inmates’ perceived and anticipated stigma: implication for post-release functioning, 12 self and identity: the j. of the int’l soc’y for self and identty, 527-28 (2013) available at http://www.ncbi.nlm.nih.gov/pmc/articles/ pmc4103667/pdf/nihms596010.pdf [https://perma.cc/5qfw-pagk]. 66 rabbi geoffrey a. mitelman, retributive justice and restorative justice, huffington post (may 4, 2011) http://www.huffingtonpost.com/ rabbi-geoffrey-a-mitelman/retributive-justice-and-r_b_857219.html [perma.cc/rw3f-a93q ]. http://dx.doi.org/10.1080/15298868.2012.702425 2016 285 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 may be wary of such a connection, no matter how attenuated, to a condemned prisoner. 67 however, this hypothetical associative stigma should not stand in the way of saving other lives. instead, stigma should be bypassed entirely. christian longo, a man serving his sentence on death row claims, “to be able to save so many lives, that means a lot to me [],”68 for many, this outlook is difficult to understand in light of longo’s history.69 longo was sentenced to die after being found guilty of killing his wife and children and throwing their bodies into an oregon waterway in december 2011.70 in an article discussing longo’s drive to donate, the author acknowledges that this sentiment is hard to hear from a man who went back to work at his job at a local starbucks outlet in the days after the murders before fleeing to mexico, where he told people he was a new york times reporter, went swimming and snorkeling, and struck up a brief romance with a woman, according to court records. when he was caught, he denied the killings.71 but what if this man’s organs could save more lives than he took? perhaps then, justice would still have been served. the horrible histories of condemned prisoners like longo surely can be cast aside when it comes to donating valuable 67 brandi grissom, considering death row for organs, the n. y. times (sept. 8, 2012), http://www.nytimes.com/2012/09/09/us/ considering-the-ethics-of-organ-donations-from-death-row.html [perma: perma.cc/b9rd-7l7u ]. 68 jonel aleccia, killer’s quest: allow organ donation after execution, nbcnews.com (april 21, 2011, 9:33 am), http:// www.nbcnews.com/id/42667886/ns/health-health_care/t/killers-questallow-organ-donation-after-execution/#.vfjmnyvf91y [http://perma.cc// 4yqw-p4dq]. 69 id. 70 id. 71 id. 286 indiana health law review vol. 13:1 and necessary organs. it is not about the pasts of the donors, but rather, the futures of the recipients. while the criminal histories of these potential donors may be a huge stigma to overcome, others may believe that prisoners are “dirty”–that their organs would not be as good as another person’s organs, due to illness or disease.72 this particular sentiment is not without merit. in 2011-12, about 4 in 10 prisoners (41%) . . . reported having a current chronic condition.”73 however, other populations around the nation have much higher rates of conditions including infectious diseases in relation to size. these populations include new york city, miami, and washington d.c.74 and yet, these populations are not scrutinized or barred from organ donation. furthering this logic, the difference between receiving an organ from a young man who had been a methamphetamine addict for ten years versus an inmate who has no access to drugs and is in a more controlled environment is politically negligible, but medically immense. how can a meth addict be allowed to donate his corneas, skin, and bone marrow, while the prisoner cannot? the reason likely does not rest purely with stigma but with the concerns held by the medical community. therefore, the hurdles posed by the medical community are the biggest obstacles to overcome if indiana is ever going to be able to pass a bill like house bill 41, as padfield tried to do. first, we must start with the role of physicians in executions and organ extraction. 72 marcus berzofsky, et. al, medical problems of state and federal prisoners and jail inmates, 2011-2012, bureau of justice statistics, http://www.bjs.gov/index.cfm?ty=pbdetail&iid=5219 [http://perma.cc/cx28-zryk] (last revised feb. 5, 2015). 73 id. at 11. 74 hiv surveillance report, 2008, ctrs. for disease control and prevention (june 2010), http://www.cdc.gov/hiv/pdf/statistics_ 2008_hiv_surveillance_report_vol_20.pdf [perma.cc/82r8-nzp5]. 2016 287 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 b. a physician’s role the tangled web that is the death penalty, and a physician’s role within it, must be unraveled if organ donation from condemned prisoners is ever to be allowed. physicians paired with the lethal injection process equates to a huge ethical challenge. historically, dr. jack kevorkian favored the lethal injection because he initially believed that it would allow inmates to donate their organs.75 he would later champion the idea of physician-assisted suicide. he believed that “only the highest degree of technical competence should be relied upon to insure trouble-free lethal injection, to avert unnecessary suffering, and, even more important, to minimize the potential danger of inadvertent suffocation of the condemned.”76 in other words, he believed that lethal injections should be performed by medical professionals. politicians must have the support from the medical community, and the legal community must have the authority from those medical boards that stand to make and analyze policy in order to gain any ground in passing a bill. however, the american medical association’s medical code of ethics states that physicians should not participate in capital punishment and executions.77 physician involvement in capital punishment is ethically banned because it violates the ethical foundations of the profession as a whole. the world medical association has condemned physician participation in prison executions. 78 75 deborah w. denno, the lethal injection quandary: how medicine has dismantled the death penalty, 76 fordham l. rev. 49, 84 (2007). 76 id., at 85 (quoting jack kevorkian, prescription: medicine, the goodness of planned death 17-99 (1991)) 77 opinion 2.06-capital punishment, am. med. ass’n, available at http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/ code-medical-ethics/opinion206.page? [http://perma.cc/a6xb-b3ux]. 78 wma resolution to reaffirm the wma’s prohibition of physician participation in capital punishment, world med. ass’n (oct. 2012), http://www.wma.net/en/30publications/10policies/c23/ [https://perma.cc/ gx5m-9h66] [hereinafter wma resolution]. 288 indiana health law review vol. 13:1 further, it has been said that, “[d]octors are not executioners. inflicting death is antithetical to their ancient creed.”79 although physician participation in some instances may arguably reduce pain in the execution procedure, there are other reasons some may cite to disallow physician participation. for example, physicians’ presence during executions may serve only to “feign the appearance of humanity.”80 the presence of a physician could be a way of showing compassion during a gruesome act. second, the physician may provide a false showing of medical legitimacy.81 third, the physician would act on behalf of the state as an executioner.82 “in return for possible reduction of pain, the physician, in effect, acts under the control of the state, doing harm,” a seemingly deliberate violation of the world medical association’s prohibition.83 mirroring those three reasons to disallow physician participation, the medical ethics community blatantly condemns physician participation in lethal injection execution; further, two states even statutorily forbid doctors from participating in such executions.84 despite the numerous concerns, ethicists must understand that, “since the inception of capital punishment, physicians have aided in the execution process.” 85 still today, doctors may be used to ensure adequate measures are taken, and that the execution procedures go according to plan. ultimately it may be determined “that a physician's 79 medical ethics and physician involvement, human rights watch (2014) available at https://www.hrw.org/reports/1994/usdp/8.htm [perma.cc/ s9fs-hfhd] (quoting kim thorburn, doctors and executions, 7 am. j. of dermatopathology (1985)). 80 id. 81 id. 82 id. 83 wma resolution, supra note 78. 84 ky. rev. stat. ann. § 431.220(3) (2015); 725 ill. comp. stat. 5/119-5(d-5) (2015). 85 stacy ragnon, a doctor’s dilemma: resolving the conflict between physician participation in execution and the ama’s code of medical ethics, 20 u. dayton l. rev. 975, 976 (1995). 2016 289 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 presence is necessary [for] a responsible execution, [so] physician participation will not be barred.”86 however, physicians who decide to participate in the lethal injection process face harsh consequences like license revocation or other severe consequences. 87 despite these consequences, those physicians who choose to violate the creed and the call to the profession should not face legal consequences if those actions were to ensure that an execution was performed responsibly and successfully. c. the lethal injection process lethal injection is the primary method of execution used in all united states jurisdictions that still retain the death penalty. indiana is among those states.88 however, that was not always the case. the united states supreme court held in furman v. georgia that the statutory imposition of the death penalty in sentencing was unconstitutional because it violated the cruel and unusual punishment clauses of the eighth and fourteenth amendments.89 however, indiana, only one year later, in 1973, “enacted a new death penalty sentencing statute to replace the statute struck down by the u.s. supreme court in furman.” 90 in baze v. rees, the united states supreme court upheld the protocol of injecting the three drug cocktail (the lethal injection) in executions as used by the state of kentucky.91 the court held that there was no evidence to show that kentucky’s lethal injection procedure was “objectively intolerable” and therefore the procedure did not violate the eighth amendment. 92 86 id. (quoting 58 fed. reg. 4898 (jan. 19, 1993)). 87 id. 88 ind. code § 35-38-6-1-(1) (2015); ind. code § 35-50-2-9 (2015). 89 furman v. georgia, 408 u.s. 238, 286 (1972). 90 death penalty facts, indiana public defender council 1, http://www.in.gov/ipdc/public/dp_links/indianadpfactsheet.pdf [http:// perma.cc/6mdy-gdub] (last updated july 8, 2015). 91 baze v. rees, 553 u.s. 35 (2008). 92 id., at 62-63. http://www.in.gov/ipdc/public/dp_links/indianadpfactsheet.pdf 290 indiana health law review vol. 13:1 today in indiana, the condemned are imprisoned until their execution day arrives. upon execution, the lethal injection is the method used. 93 of the states that use lethal injection as the primary means for execution, the overwhelming majority of them “essentially [use] the same three-drug cocktail: 1) sodium thiopental; 2) pancuronium bromide; and 3) potassium chloride.” 94 sodium thiopental is used to anesthetize patients, inducing an unconscious state. 95 once unconscious, mechanical ventilation is required.96 in clinical doses sodium thiopental acts quickly and lasts for a short time only; “however, when used in a massive or superclinical dose, as is the case in an execution, it is capable of reliably produc[ing] prolonged and deep unconsciousness.”97 pancuronium bromide is the next drug injected. pancuronium bromide is a neuromuscular blocking agent.98 in effect, pancuronium bromide stops respiration and ceases involuntary muscle movement. because these drugs have such severe effects, ensuring appropriate dosages, standards, and methods are of the utmost importance one mistake could have disastrous effects. the final drug injected is potassium chloride which is used to stop the heart from beating. 99 this is the most important step in the procedure. not only does this drug lead to cardiac failure, but this is the point at which donation from prisoners becomes much harder. most organ procurement is 93 ind. code § 35-38-6-1. 94 jerry merrill, the past, present, & future of lethal injection: baze v. rees’ effect on the death penalty, 77 umkc l. rev. 161, 162 (2008). 95 id. at 162; see also brief of american society of anesthesiologists as amicus curiae supporting neither party, baze v. rees, 128 s. ct. 1520 (2008) (no. 07-5439), available at https://www.law.berkeley.edu/clinics/ dpclinic/lethalinjection/li/documents/bazebriefs/asa.pdf [https:// perma.cc/59dr-8rh5]. 96 merrill, supra note 94, at 162. 97 id. at 163 (citing brief of american society of anesthesiologists as amicus curiae supporting neither party, supra note 95, at 5). 98 id. 99 id. 2016 291 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 performed following brain death, not cardiac death. therefore, “donation from death row inmates will not be like a typical brain-death donation and thus will have to be a case of controlled dcd (donation after cardiac death).”100 because the heart has stopped beating in cases of dcd, the organs do not get oxygen, meaning there may be a shorter period of time for procurement before the organs become unusable. as such, the procedure to procure organs becomes exceedingly more challenging in the execution setting due to the execution methods used. however, just because the setting is different, does not mean that the tissues sought are somehow different. procedures and methods can change. d. jury deliberations another substantial hurdle in gaining support for a bill to allow for death row organ donation is the risk that juries and judges may be more inclined to hand out death sentences. that is, jurors may believe that criminals should pay back society for their wrongs by giving up their organs (or so the logic would go). juries do not always make decisions based purely on the evidence presented; other variables and stereotypes interfere with jury verdicts as it is. concerns regarding higher incidences of death sentences rest on this basic assumption. furman v. georgia originally addressed the issue of inappropriate death sentences due to bias and prejudice.101 there, the court was concerned that death sentences could be imposed at the unfettered discretion of judges and of jurors – that “people die dependent on the whim of one man or of [twelve].”102 sometimes jury decision-making may not focus entirely on the evidence presented at trial. jurors are not immune from internal psychological impulses no matter how 100 shu lin, lauren rich, jay pal & robert sade, prisoners on death row should be accepted as organ donors (july 3, 2012), http:// www.ncbi.nlm.nih.gov/pmc/articles/pmc3388804/ [http://perma.cc/ s4mn-tfhq]. 101 furman v. georgia, 408 u.s. 238 (1972). 102 id. at 253. http://dx.doi.org/10.1016/j.athoracsur.2012.03.003 292 indiana health law review vol. 13:1 obviously prejudicial these impulses are. it is hard to determine whether organ donation would be analogous to considerations of race, previous convictions, or confidence of a defendant, in jury decision-making paradigms, but it is a genuine concern held by the legal community.103 before the year 2002, a jury’s sentence in death penalty cases in indiana was nothing more than a nonbinding recommendation to the court. in ring v. arizona, the united states supreme court held that a judge, even in determining appropriate sentencing, could not conduct a factual inquiry to find for the presence or absence of aggravating factors that would lead to the imposition of the death penalty; a jury, by the mandate of the sixth amendment must engage in that type of determination. 104 because of the supreme court’s holding in that case, “the 2002 general assembly amended our death penalty statute to provide that if a jury unanimously reaches a recommendation, the trial court must ‘sentence accordingly.’” 105 though the standard for the death penalty is set quite high, unanimous decisions can still be born of both conscious and unconscious bias. stereotypes of groups of people necessarily inform these biases because they “operate as source[s] of expectancies about what a group as a whole is like . . . as well as about what attributes individual group members are likely to possess. . . .” 106 that is, jurors may see a defendant as a member of a group and then apply characteristics to that defendant based on that group’s purported stereotype. stereotypes can affect a “perceiver’s attention to, encoding of, inferences about, and judgments 103 dennis j. devine, et al., jury decision making: 45 years of empirical research on deliberating groups, 7 psychology, pub. pol. & l. 622 (2001). 104 ring v. arizona, 536 u.s. 584, 609 (2002). 105 death penalty facts, supra note 90, at 3. 106 nancy king, postconviction review of jury discrimination: measuring the effects of juror race on jury decisions, 92 mich. l. rev. 63, 77 (1993); david hamilton et al., stereotype-based expectancies: effects on information-processing and social behavior, 46 j. soc. issues, 35, 43 (1990). http://dx.doi.org/10.1037/1076-8971.7.3.622 http://dx.doi.org/10.2307/1289642 http://dx.doi.org/10.1111/j.1540-4560.1990.tb01922.x 2016 293 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 based on that information.”107 resulting cognitions reflect the previous patterns of information received.108 in other words, confirmation bias acts to bring what people see and hear (i.e. what the jurors would see and hear) in line with what people believe or what society has conditioned them to believe about something or someone. this opens the door to bias. in turner v. murray, the united states supreme court determined that juror latitude mixed with prejudice may prove to be too risky a combination to leave unbridled.109 in its opinion, the court stated that “the range of discretion entrusted to a jury in a capital sentencing hearing [poses] a unique opportunity for racial prejudice to operate but remain undetected . . . .”110 thus, the court determined that “a capital defendant accused of an interracial crime is entitled to have prospective jurors informed of the race of the victim and questioned on the issue of racial bias.”111 theoretically, this line of questioning would serve to detect hidden biases present within the juror pool. though evidence points to several accounts of juror decision-making that seem hardly ethical—decisions and sentences based on faulty cognition, racial prejudice, and psychological pull,—we may be able to rule out this hurdle in the realm of death row organ procurement fairly quickly. just as our legislature should not make laws that seek to pierce through unconscious motives—mostly because this would be impossible and because it would be difficult to exact within a statute—laws surrounding the death penalty and organ donation would be unable to circumvent any prejudice that already exists in relation to the death penalty overall. it is not the same to say that jurors are more likely to hand down the death penalty for african american men as it is to say that if someone does not believe in the death penalty suddenly he or she will if death row prisoners were allowed to donate their organs. further, it is not as if the government would force these inmates to donate. moreover, if juror 107 king, supra note 106, at 77. 108 id. 109 turner v. murray, 476 u.s. 28 (1986). 110 id. at 35. 111 id. at 36-37. 294 indiana health law review vol. 13:1 prejudice were a true concern in death penalty cases (where statutorily an inmate could donate), those jurors that would foreseeably pose problems to the defendant’s case could be weeded out just like any other. iv. padfield and house bill 41 – a history of pushing for procurement all legal, ethical, and medical reasons aside, indiana’s representative padfield had the right idea. condemned prisoner donation, while not the end of the organ shortage, is surely a step in the right direction. a bill like house bill 41, would not be without at least some support from constituents of the state. as an example, in an ongoing internet poll on a webpage seeking to gauge opinions on controversial and popular issues, (as of november 17, 2015), 60% of web participants agreed with padfield; that is, that prisoners should be allowed to donate organs. 112 as stated by a condemned prisoner, mimicking one side of the spectrum of sentiments felt by the community, “[w]hy go out and waste your organs when you have the potential to go out and save six to [twelve] lives?” 113 a. what happened? the padfield bill did not pass. it was likely due to the immense stigma (yet likely undisclosed and unvoiced) attached to this topic, the distaste for subtracting from retributive justice, and the impossible battle lawmakers and the medical community would face in establishing protocol. the fight to get these kinds of bills passed is still alive as is the fervor with which proponents of it fight. christian longo still fights for his right to donate, and, similarly, up until his execution, gregory johnson fought for his ability to donate as well. 112 should death row inmates donate their organs, debate.org, http://www.debate.org/opinions/should-death-row-inmates-donate-theirorgans [http://perma.cc/qz32-fd5p ] (last visited nov. 17, 2015). 113 aleccia, supra note 68. 2016 295 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 b. no legislation since bill 41 in indiana legislation of this kind will likely not be brought back to the table in indiana until there is clear evidence that a number of things can change. the method of execution would have to change. though, as aforementioned, donation after cardiac death can be a viable way to harvest healthy organs, the lethal injection process and the hurdles regarding its implementation are too strong to overcome. it is likely that in order for organs to be viable following execution, procedures must preserve the integrity of the organs. tackling a method of execution, however, should not be the first order of business. rather, the role of physicians would have to change. v. overcoming challenges a. changing the role of physicians in executions in order to procure organs from executed prisoners, a physician must be present. though it may see macabre and somewhat voodoo, physicians and death are not strangers. in fact, dr. joseph guillotin was a french physician who developed a method of execution – the guillotine. 114 he believed executions by this method would relieve pain in death; he later faced many critical responses following this invention.115 further, by 1982, there was clear evidence of physician involvement in executions within the united states.116 condemned prisoner charles brooks was set to be executed in 1982 by lethal injection. 117 dr. ralph gray participated in the injection in a limited capacity. “he [] 114 medical ethics and physician involvement, supra note 79. 115 id. at 5. 116 id. 117 id.; see also robert reinhold, technician executes murderer in texas by lethal injection, n.y. times (dec. 7, 1982), http:// www.nytimes.com/1982/12/07/us/technician-executes-murderer-in-texasby-lethal-injection.html [https://perma.cc/5kjf-56uf]. 296 indiana health law review vol. 13:1 examine[d] the prisoner to make sure his veins were large enough to accept the needle . . . .”118 after the injection, dr. gray was ultimately the one to pronounce brooks dead.119 in that case, the physician, dr. gray, did everything but inject the drugs. dr. gray monitored the inmate, assisted the executioner, pronounced death, and oversaw the general sequence of events. this, by some standards, could be seen as a physician-assisted execution. it is hard to grasp that there is room for physicianassisted suicide, but not physician-assisted organ procurement in executions. is there really a difference? many u.s. physicians get requests for assisted death and assisted suicide, and of these physicians receiving requests, roughly six percent have accepted on at least one occasion.120 1. exploring the case of brittany maynard recently in the news was the case of brittany maynard, a woman diagnosed with a terminal form of brain cancer.121 at only twenty-nine years of age, brittany made the decision to end her life.122 facing the prospect of terrible side effects from radiation, and the symptoms of the brain cancer itself, maynard and her husband journeyed to oregon in search of the death with dignity law.123 118 tamar lewin, execution by injection: a dilemma for prison doctors, n.y. times (dec. 12, 1982), http://www.nytimes.com/1982/12/12/ weekinreview/execution-by-injection-a-dilemma-for-prison-doctors.html [https://perma.cc/l47n-uwj7]. 119 patton, supra note 2, at 392. 120 diane e. meier, et al., a national survey of physician-assisted suicide and euthanasia in the united states, 338 new eng. j. med. 1193 (1998), available at http://www.nejm.org/doi/full/10.1056/ nejm199804233381706 [http://perma.cc/bfg9-yddu]. 121 brittany maynard, my right to death with dignity at 29, cnn news, http://www.cnn.com/2014/10/07/opinion/maynard-assistedsuicide-cancer-dignity/ [http://perma.cc/u98c-btkb] (last updated nov. 2, 2014 10:44 pm). 122 id. 123 id. http://www.cnn.com/2014/10/07/opinion/maynard-assisted-suicide-cancer-dignity/ http://www.cnn.com/2014/10/07/opinion/maynard-assisted-suicide-cancer-dignity/ http://dx.doi.org/10.1056/nejm199804233381706 2016 297 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 oregon, in 1994 passed a one-of-a-kind law that allowed terminally ill patients to access physician assisted suicide.124 in effect, the law allowed competent, adult patients to receive a physician-authorized prescription for drugs that would result in death. 125 the law was greeted with scorn and apprehension from many across the nation and especially in oregon. the law barely passed: “[t]he statewide vote was 51% in favor and 49% opposed [in 1994].”126 even after its initial passage, the bill’s enforcement was enjoined, only later to wind up as a hot topic in the united states supreme court. the court held that there was a distinction “between ‘physician-assisted suicide’ and withdrawal of life support or the ‘double effect’ of aggressive palliative care.” 127 in essence, the court did not see oregon’s law as a constitutional issue, but rather one of politics. thus, the law took full effect in 1997.128 maynard took advantage of the passage of this law and moved from california to oregon to seek death with dignity. 129 she passed away after taking her prescribed medication in late 2014.130 many, like maynard, have done the same since oregon’s law has gone into effect. “more than 750 people in oregon used the law to die as of dec[ember] 31, 2013 . . . only six were younger than 35, like maynard.”131 124 or. rev. stat. §§ 127.800-127.897 (2015); see also patrick dunn et al., the oregon death with dignity act: a guidebook for healthcare professionals 4 (2008), available at https:// www.ohsu.edu/xd/education/continuing-education/center-for-ethics/ ethics-outreach/upload/oregon-death-with-dignity-act-guidebook.pdf [http://perma.cc/r8pt-rw7e]. 125 dunn et al., supra note 124. 126 id. at appendix a. 127 id. appendix a, at 113. 128 id. 129 death with dignity advocate brittany maynard ends her life, cbs news (nov. 2, 2014, 10:22 pm), http://www.cbsnews.com/ news/ death-with-dignity-advocate-brittany-maynard-ends-her-life/ [http:// perma.cc/88fa-juzp]. 130 id. 131 id. 298 indiana health law review vol. 13:1 2. oregon’s death with dignity act and the hippocratic oath following the widespread recognition of maynard’s case, a documentary, that was unveiled in 2011, rose in popularity. it was entitled: “how to die in oregon.”132 this documentary explores real life responses to oregon's ‘death with dignity act,’ the first law in the u.s. to allow physicians to prescribe lethal doses of drugs to the terminally ill. a middle-aged woman with terminal liver cancer, prepares to take her own life, while another cancer patient decides to suffer through his illness even though death is just as certain for him. others grapple with choosing their own course of action, and one man decides to hold a ‘death party.’133 the film explores the problems patients encounter when their decision ultimately is to die. for the most part, the film highlights the relief each patient feels for having the opportunity to assert his or her “right to die” under the oregon law. while it is most difficult for the family members who must sit idly by and watch helplessly, the film truly hones in on the power the patient holds in determining his fate. there are two interesting components of the film that must be addressed, especially in relation to the issue of death row organ procurement and the involvement of the medical community. there is no doubt that oregon’s medical community has established many protocols, rules, and guidelines to traverse the confusing realm of its law. as such, 132 how to die in oregon (2011), available at http:// www.imdb.com/title/tt1715802/ [http:/perma.cc/ay9y-lcy4] (last visited oct. 11, 2015). 133 how to die in oregon, movie fone, http://www.moviefone.com/ movie/how-to-die-in-oregon/10054198/main [http://perma.cc/v7pwmrmz] (last visited nov. 17, 2015). 2016 299 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 medical ethicists and legal scholars are especially interested in the safeguards and methods employed in carrying out this law. however, though the statute was passed, and though the procedures have been tried, verified, and found to be adequate, there are potential problems with the processes instituted before the patient ingests the lethal medication. indiana residents, as viewers and as members of a population somewhat detached from this oregon law, must assume that the real-life accounts portrayed in the film are the actual and true ways that the right to die law is carried out. building on this assumption, the analysis of risk can begin. in the film, a volunteer arrives at the patient’s home and speaks with him before the medication is taken. 134 the volunteer tells the patient how to crush the pills, how much water to mix in, what it will taste like, and how long it will take for him to die.135 additionally, the volunteer asks the patient two questions: first, the patient is informed that he has the right to change his mind and if he would like to presently do so; second, the patient is asked if he knows what the medication will do.136 to a politician and to a potential patient, these questions may seem adequate–they probe competency and underscore the possibility for liability. however, once in the position of comparing this process with that of the potential criteria for death row organ procurement, one must employ a deeper, more microscopic analysis. a large potential problem with this procedure is that a volunteer, not a physician or a nurse, is present during the ingestion of the drugs and is present for the death. a volunteer is the one who asks these questions in an effort to categorically determine understanding and competency. why is a volunteer the judge of the mental health and competency of a patient prior to the time of death? why is a volunteer the one overseeing the process? granted, the volunteers are likely adequately trained before engaging in this process, but the risk is ultimately too high regarding 134 how to die in oregon (peter d. richardson, 2011). 135 id. 136 id. 300 indiana health law review vol. 13:1 liability and bioethics to allow anyone other than a medically trained and licensed professional to oversee this process. the potential for mistakes, the questions that could be posed and then incorrectly or ignorantly answered, and the way in which the patient takes the drug, are all potentially catastrophically harmful situations. what would happen if two gulps into the drug cocktail the patient changes his or her mind? how would a volunteer be equipped to handle such a hazardous situation? realistically, the patient’s physician should be there. secondly, that there are so few questions posed moments before the medication is to be ingested raises serious concerns regarding willingness, competency, safety, and liability. these questions only seek to uncover whether the person knows he will die upon taking the drug, and whether he wants to change his mind. this could be troublesome. would the fact that others (for example, family members and friends of the patient) are present for these questions change the answer? would the patient feel compelled to say that he did not want to change his mind? how could a person asking these questions gauge competency invariably? there is no battery of questions, no history of psychological screenings, and no tests – it is just too easy. the process of end-of-life decision-making does not square with that of the lethal injection. each offers the same result: death. and yet, one offers physician-prescriptive help to achieve the result while the other doesn’t. one is established with relatively relaxed bioethical safeguards while the other has heightened ones. as such, oregon’s death with dignity law ties a close knot to the ethics behind organ donation of death row inmates and parallels some key concerns, especially regarding physician involvement. the same concerns held by the medical community when physicians participate in the lethal injection process are highlighted in right to die laws. doctors may not inflict death–to do so would be “antithetical to their ancient creed.”137 this argument is used to prevent physicians from 137 medical ethics and physician involvement, supra note 79 (quoting kim thorburn, doctors and executions, 7 am. j. of dermatopathology (1985)). http://dx.doi.org/10.1097/00000372-198502000-00018 2016 301 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 meddling in the lethal injection process. it is used to prevent physicians from developing ways to procure organs during the “death process,” and it is used to disallow a method of execution that would necessarily entail organ harvest. and yet, this argument is cast aside when it comes to oregon’s death with dignity law. it seems contrived that our medical community and political infrastructure could pick and choose when to employ this reasoning. many may view the difference between physician involvement in lethal injections versus their involvement with right to die patients as an informed consent issue. right to die patients must be deemed competent, and must jump through several hoops before being able to be prescribed the lethal medication. on the other hand, those inmates who must face death do not get the luxury of informed consent for any portion of the process. the state decides. the physician involvement distinction is negligible. despite the fact that there is finer print and more safeguards to acquire informed consent in right to die cases, there could never, ever be such a strict and humanitarian standard for executions. courts, juries, politics, and state governments, in essence, act as the informed consent counselors. just because one form of doctor-induced death operates on a different set of standards does not mean that by default medical rules and ethics apply more so to that one. the hippocratic oath and a doctor’s involvement in death in the most general sense must be a level platform if a medical ethics argument is to be used to prevent incarcerated organ donations. to apply the oath in only some cases would take the vigor out of the standards themselves. in addition to the informed consent and medical standards parallel, residents of indiana should consider right to die laws and ask what the true difference is between physician-prescribed death and physician-assisted death. as stated before, one of the ways to overcome challenges in passing a bill to allow for organ procurement from death row inmates would be to rewrite the role of physician involvement in executions–to either write them out of the process completely, or more effectively, to allow them to participate in organ extraction during a brain death execution as opposed to a cardiac death execution. here, 302 indiana health law review vol. 13:1 dissidents claim that to allow a doctor to do this allows him to be the executioner himself. one would have to ask then, what was the role of the physician who prescribed brittany maynard her lethal prescription? using that logic, is he not the executioner as well? a key question as posed by dr. david waisel, an anesthesiologist with the mayo clinic is: “whether the physician is acting as a tool of the individual to minimize suffering and to further the individual's goals or whether the physician is acting as a tool of the government to ensure a successful execution.”138 if an inmate wishes to donate his organs, in theory, a physician conducting the procurement would be ensuring that this inmate’s wishes are carried out and that his goals are attained, rather than acting as the “hand of death” on behalf of the state. in other words, the goal of the doctor providing comfort and the goal of the state in executing a criminal have aligned139 in a seemingly perverse way. it is hard to draw the line that physician participation in death is fine for patients in oregon, but is inexcusable in the eyes of the medical community for condemned inmates. first, patients who seek oregon’s death with dignity law are invoking their right to their own health autonomy. physicians who assist these patients, in effect are respecting the patient’s autonomy. the argument put forth by proponents of the right to die is that, “[c]ompetent people should have the right to choose the timing and manner of death.”140 physicians tout the importance of respecting this right; competent individuals must never be deprived of their personal and patient autonomy. 141 however, condemned 138 david waisel, physician participation in capital punishment, 82 mayo clinic proceedings 1073, 1076-77 (2007) (discussing the nature of physician involvement in executions). 139 id. at 1077 140 helene starks et al., physician aid-in-dying, ethics in med. u. wash. sch. med. (2013), https://depts.washington.edu/bioethx/topics pad.html [http://perma.cc/v7jy-c88v]. 141 declaration of lisbon on the rights of the patient, world med. ass’n., (reaffirmed april 2015) available at http://www.wma.net/en/ 30publications/10policies/l4/ [perma.cc/ymv5-zlbl]. the third patient http://dx.doi.org/10.4065/82.9.1073 2016 303 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 inmates are denied the right to autonomy in their end of life choices altogether. the denial of this right is stretched to bar choices about the fate of their own organs. nonetheless, respect for autonomy cannot be the end-all be-all of physician involvement arguments. second, there is no distinction between active and passive death either in executions or in physician-prescriptive death.142 brittany maynard’s doctor in oregon prescribed her medication to take.143 there is nothing passive about this kind of death. the medication was deliberately requested and prescribed. similarly, in executions, the method is not passive; it is active. the injections are deliberately administered. therefore, in a very crass sense, an active “killing” exists on both sides of the spectrum; yet, one is tolerated, and the other is not. in washington v. glucksberg, the united states supreme court found that the right to assisted suicide was “not a fundamental liberty interest that is protected by the due process clause.”144 further, the supreme court in vacco v. quill, held that a new york law prohibiting “assist[ed] suicide [did] not violate the equal protection clause.”145 this in effect left it up to each state to decide whether or not to legalize physician-assisted suicide. 146 thus, courts have continually recognized both liberal interpretations of right to die laws while still limiting the enforceability of such broad life-ending rights. oregon’s right to die law raises serious questions about the integrity of medical ethics. while many may not want to agree, the circumstances facing the physicians who choose to participate in patients’ right to die plans, are the same right listed, “right to self-determination,” states: “the patient has the right to self determination, to make free decisions regarding himself/herself.” 142 id. 143 lindsey bever, cancer patient brittany maynard, 29, has scheduled her death for nov. 1, wash. post (oct. 8, 2014), https:// www.washingtonpost.com/news/morning-mix/wp/2014/10/08/terminallyill-brittany-maynard-29-has-scheduled-her-death-for-nov-1/ [https:// perma.cc/3ref-yuqc]. 144 washington v. glucksberg, 521 u.s. 702 (1997). 145 vacco v. quill, 521 u.s. 793 (1997). 146 id. 304 indiana health law review vol. 13:1 circumstances that physicians would be facing in organ extraction executions. the point is this: wavering medical ethics provide no true guiding light to overcoming serious challenges in not only condemned prisoner organ procurement, but in all facets of medical decision-making. therefore, physicians can and should be involved in the execution process. if the legal and medical community cannot come together as they did in establishing oregon’s death with dignity law, perhaps the indiana community can still achieve medical reform to allow for death row organ procurement nonetheless. physicians may not even need to be the ones to do the lethal injection at all. in turn, this would purge them of any ties to the actual death, rendering them capable of procuring the inmate’s organs thereafter. prisons commonly hold required trainings prior to the execution date where participants are educated regarding the process and their responsibilities. as an example highlighted by the state of kentucky, there, the prison implements training sessions regarding the lethal injection process to those individuals who play integral roles. 147 among those involved in the training are emt’s.148 allowing emts or any other health professional to administer an iv (the channel for lethal injection drugs) would overcome the ethical dilemma raised by physician participation. the physician may be in attendance to pronounce death but not to administer the process that ultimately results in death. the physician could then extract organs. here physicians would be fulfilling their roles as caregivers as they would be extracting and procuring organs on behalf of the transplant recipients. b. changing the nature of lethal injection in addition to renegotiating the role of physicians and the staff used for executions, the method of execution could be 147 baze v. rees, 553 u.s. 35, 118 (2008). 148 id. 2016 305 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 altered. the lethal injection may not be the best model for organ procurement purposes. in the clinical setting, organ transplantation surgeries are typically performed on patients whose hearts are still beating, but who have reached brain dead status.149 the goal in harvesting organs from executed prisoners would in theory be to mimic a clinical transplantation as much as possible. therefore, achieving brain death would be ideal in order to procure organs while the person’s heart still beats. to this end, the introduction of anesthesia in “excessive amounts” would lead to death with a still-beating heart in a seemingly simpler process.150 this could be the new lethal injection process. doctors perform organ procurement operations on brain dead, yet heart-beating patients all the time. unlike donation upon cardiac death, brain death donations may yield far greater results due to the fact that the heart is still beating and is still able to provide oxygenated blood to all tissues. changing the lethal injection would not destroy a flawless process. the injection has faced its fair share of problems. botched executions are not entirely uncommon. on january 9, 2014, michael wilson was executed in oklahoma by lethal injection.151 as the drugs were introduced, wilson remarked, “i feel my whole body burning.”152 he was dead shortly after uttering this sentiment.153 the pain he felt during the lethal 149 d.w. mckeown, et. al., management of the heartbeating brain – dead organ donor, 108 british j. anaesthesia 96 (2012) available at http://bja.oxfordjournals.org/content/108/suppl_1/i96.full.pdf+html [https://perma.cc/6bcv-2qm9]. 150 paul kempen, lethal injection, anesthesia, medicine and organ donation – ethical and clinical consideration regarding the pending supreme court case: baze v. rees, 2 open anesthesiology j. 7-9 (2008) http://benthamopen.com/contents/pdf/toatj/toatj2-7.pdf [http://perma.cc/yhk7-xmr8]. 151 graham lee brewer, condemned man’s last words lead to questions about lethal injection ‘cocktail’ in oklahoma, u.s., the oklahoman (feb. 9, 2014), http://newsok.com/article/3932043 [http://perma.cc/v3ap-guvh]. 152 id. 153 id. http://dx.doi.org/10.1093/bja/aer351 http://dx.doi.org/10.2174/1874321800802010007 306 indiana health law review vol. 13:1 injection raised serious concerns regarding the safety and effectiveness of the chemicals used in the process.154 in a separate instance, clayton lockett, after the drug cocktail was administered, moaned and jerked on the gurney. 155 edith shoals, who was present as a victim advocate described the scene as “like a horror movie . . . he kept trying to talk.”156 debate spurred on whether to take lockett to a hospital or not, but lockett died soon after.157 nothing went according to plan. additionally, in 2009, ohio attempted to execute a man named romell broom.158 officials could not find a vein to insert the iv; instead records indicate that officials stuck him eighteen times until the governor finally terminated their efforts.159 other instances perpetuate the need for change in lethal injection procedure. in light of the need for organs, and in light of the rights denied to death row inmates, this change could and should incorporate medical techniques that not only allow for a more humane death, but also for a death that would be conducive to organ procurement. the problems with lethal injection procedure will not fix themselves. and, like any medical complication, medical adjustments, not political ones, will be the best corrective action. the lethal injection is dangerous as it is. if the process of death went from cardiac death to brain death, 154 id. 155 scene at botched oklahoma execution of clayton lockett was a ‘bloody mess,’ theguardian.com, http://www.theguardian.com/ world/2014/dec/13/botched-oklahoma-execution-clayton-lockettbloody-mess [http://perma.cc/h4mh-6jjt] (last visited nov. 18, 2015). 156 id. 157 id. 158 tracy connor, top court will hear rommell broom’s execution do-over appeal, nbc news (june 3, 2014), http:// www.nbcnews.com/storyline/lethal-injection/top-court-will-hearromell-brooms-execution-do-over-appeal-n121366 [http://perma.cc/4j5d-656p]. 159 id. 2016 307 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 many of these botched injections would not have happened. rather, the patients would have eventually “overdosed” on anesthesia160–a relatively peaceful and pain free process. further, allowing for physician involvement would accomplish two things. first, if a medical complication were to arise during the execution, the physician would be there to make the right call. there would be no lengthy debate on whether hospitalization was or was not necessary as was the case for lockett’s execution. second, the physician could be there to do the organ procurement. this would not only ensure that the organ extraction was done in a timely manner, but that it was done with the kind of precision that is required. adjusting simple techniques and restructuring the staffing procedure for executions may provide room to overcome bioethical challenges. performing organ procurement as a means of execution—that is, brain death executions versus cardiac death executions—would not only overcome problems associated with the adverse biological effects of the lethal injection, but would also allow other trained personnel (other than licensed physicians) to be a part of the execution process, circumventing any potential issues that may arise from medical ethics communities regarding physician-involved executions. c. bill reintroduction is a necessity indiana has the potential to turn the dial in advancing the evolution of the field of bioethics and to set precedent in the law. just as oregon made waves in instituting the death with dignity act, so too can the state of indiana make waves. passing a bill to allow for organ procurement from death row inmates will not cure the organ deficit, nor will it change stigma and opposition from certain members of society, but just as oregon’s act was intended to grant justice to those who had no other recourse, a bill to allow death row inmates 160 kempen, supra note 150. 308 indiana health law review vol. 13:1 to donate organs would grant justice to those also without recourse. those inmates condemned to die would have the opportunity to reach for atonement and reveal their humanity – a final act of selflessness and autonomy while incarcerated. ultimately, in truth, the number of organs that would end up viable and transplantable may be miniscule. nonetheless, there is something much greater at play. denying these people—because yes, inmates are people—the right to donate, infringes on a basic tenant of personal autonomy that not even a death sentence can remove. these prisoners seek, in their final hour, to have one last attempt to overcome their pasts. whether to atone or to demonstrate a manifestation of their own humanity, these prisoners continue to pursue organ donation. in light of oregon’s new law, in light of the measures attainable to overcome bioethical barriers, and in light of the methods with which organ procurement within the execution process are possible, there is no reason why another bill like house bill 41 could not be reintroduced and passed. stigma will not perish, nor will resentment from victims’ families and other members of the community. yet, despite trepidation from all fronts of opposition, a new bill should and must be reintroduced. to continue to deny organ transplants to the dying and to deny organ donation to the almost dead seems too great a burden for our state to bear–killing two by denying rights to one. it is time to re-think the system. it is broken and it can be reworked. in his concurrence in cruzan v. director, missouri department of health, justice scalia highlighted the liberty interests at stake in end-of-life decision-making, writing that “[t]he text of the due process clause does not protect individuals against deprivations of liberty . . . . [i]t protects them against deprivations of liberty ‘without due process of law.’”161 while the cruzan case does not delve into the realm of incarcerated individuals, the holding marks an important concept that must be actualized. all people hold the biological 161 cruzan v. director, mo. dep’t of health, 497 u.s. 261, 293 (1990). 2016 309 justice for jailbirds: summoning bioethical liberation for death row and reinventing indiana’s house bill 41 rights to do with their bodies what they wish. under the strength and steadfastness of the law, due process should adequately protect this right, because all people deserve, at the end of their lives, to be the apex of authority for the liberties of their bodies–for in death, everyone is a vulnerable prisoner. microsoft word final for lulu vol. 14 issue 1 final indiana health law review a. inspect – indiana’s pdmp a. trends in opioid dispensations b. doctor-shopping factors associated with inspect use frequency of inspect use change in prescribing practices in the past twelve months http://doi.org/10.18060/3911.0031 vital signs: overdoses of prescription opioid pain relievers—united states, 1999-2008 vital signs: united states 1999-2008 see also prescription drug abuse: insight into the epidemic who uses a prescription drug monitoring program and how? insights from a statewide survey of oregon clinicians https://doi.org/10.1038/clpt.2010.154 https://doi.org/10.1016/j.jpain.2014.04.003 id. abuse of prescription drugs and the risk of addiction economic costs of nonmedical use of prescription opioids prescription opioid overdose data see major increases in opioid analgesic abuse in the united states: concerns and strategies see also prescribing of controlled medications to adolescents and young adults in the united see also opioid prescriptions soar: increase in legitimate use as well as abuse see also therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids see also the prescription drug epidemic in the united states: the perfect storm opioid painkiller prescribing: where you live makes a difference vital signs: united states 1999-2008 supra opioids see generally (melissa h. hargraves et al. eds., (2015). https://doi.org/10.1016/j.drugalcdep.2005.10.020 https://doi.org/10.1097/ajp.0b013e3181ff04ca https://doi.org/10.1016/j.drugalcdep.2005.05.009 https://doi.org/10.1542/peds.2010-0791 https://doi.org/10.1001/jama.297.3.249 https://doi.org/10.1111/j.1465-3362.2011.00291.x estimating the prevalence of opioid diversion by “doctor shoppers” in the united states, see, e.g prevalence and determinants of pharmacy shopping behaviour , a history of being prescribed controlled substances and risk of drug overdose death doctor and pharmacy shopping for controlled substances doctor and pharmacy shopping for controlled substances, supra prescription drug monitoring programs id.; see also pdmp ttac, faqs, pdmp faqs https://doi.org/10.1371/journal.pone.0069241 https://doi.org/10.1111/j.1365-2710.2008.00878.x https://doi.org/10.1111/j.1526-4637.2011.01260.x https://doi.org/10.1097/mlr.0b013e31824ebd81 a. inspect – indiana’s pdmp central repository for controlled substances data about inspect about inspect id. id. id. faqs about inspect supra id. id. a. trends in opioid dispensations inspect about inspect supra see see also supra supra indiana inspect data set—2014 figure 1. trends in opioid dispensations in indiana, 2010-2015 table 1. frequency of most commonly dispensed opioids 35 id id table 2. opioid dispensations by demographic characteristics b. doctor-shopping id id. indiana inspect data set—2014 table 3. comparisons between individuals who were and were not doctor-shoppers in 2014 id. id. id. id. id. id. id. id. id. table 4. composition of inspect survey sample , id. id. id. id. id. id. table 5. knowledge of inspect id. id. id. id. less table 6. use of inspect by professionals who knew of inspect id. id. id. see id. table 7. description of outcome and predictor variables used in analyses a. factors associated with inspect use chi sq. = 587.222, p<.001; nagelkerke r sq. = .303 table 8. binary logistic regression predicting any use of inspect b. frequency of inspect use id. chi sq. = 199.139, p<.001; nagelkerke r sq. = .181 table 9. predictors of frequency of inspect use c. change in prescribing practices in the past twelve months chi sq. = 179.431, p <.001; nagelkerke r sq = .141 table 10. predictors of change in prescribing behavior id. id. prescription drug monitoring programs, a response to doctor-shopping: purpose, effectiveness, and directions for future research https://doi.org/10.3109/01612840.2011.654046 anti-vaccine misinformation and the law: challenges and pitfalls dorit rubinstein reiss partial transcript of the virtual grand rounds summer series lecture* june 25, 2020 professor reiss: thank you for having me, and i am overwhelmed by this introduction. also, like you, i hope that everybody is staying safe. my focus today is: what legal tools do we have to handle outbreaks that can be traced to misinformation? most of my talk will focus on anti-vaccine misinformation because that is where i started looking at this. i will end the talk with some reference to covid-19 misinformation, which is a growing public topic. i want to mention that my family owns some regular stock in gsk, which is a vaccine manufacturer. i am not sure that is related to what i am talking about today, but it is better to have more disclosure than less. imagine the following scene. an anti-vaccine organization puts out misinformation that deters people from vaccinating. this could lead to an outbreak. for example, if you look at the bottom of the slide, this is a graph of cases of measles in the united states over the past decade.1 if you look at it, you will see that over the past few years we have had several large outbreaks that can be traced to anti-vaccine misinformation. this is the kind of harm that can result from misinformation. an unvaccinated child can get sick. the parents may consider suing the people that convinced them not to vaccinate. also, an unvaccinated child can get sick and infect someone else. in this case, the family of the newly infected person may want to sue the organization for promoting this information. moreover, an outbreak can cause colossal harm to a community, and the state public health department may want to remedy the misinformation on behalf of the community. the minnesota measles outbreaks are examples of how vaccine misinformation can harm communities. minnesota had one of the largest somali immigration communities in the united states. when the community came in, they had very high rates of vaccination. in 2004, 92% of somali children were vaccinated against measles, mumps, and rubella with the mmr vaccine. later, a study suggested that autism rates in the community were high. this led to concerns about autism. then, rumors spread around the community that the mmr vaccine created autism. these rumors spread through online research by members of the community and anti-vaccine groups. as a result, the rates of * indiana health law review and the william s. and christine s. hall center for law and health at the indiana university robert h. mckinney school of law give special thanks to professor dorit rubinstein reiss for participating in the virtual grand rounds summer series and providing her perspective on anti-vaccine misinformation. professor reiss is a professor of law at the university of california, hastings college of the law. 1. measles cases and outbreaks, ctr. for disease control & prevention (nov. 5, 2019), https://www.cdc.gov/measles/cases-outbreaks.html [https://perma.cc/zl94-6jlk]. 86 indiana health law review [vol. 18:85 mmr vaccination dropped to 42%. unsurprisingly, outbreaks formed.2 in 2011, the first outbreak happened. a thirty-month-old unvaccinated child traveled to kenya. the child returned with measles and infected twenty other children. seven of these children were too young to vaccinate, and nine others were left unvaccinated by choice.3 further, fourteen of these children were hospitalized, and one of them ended up in the emergency room. nonetheless, the anti-vaccine efforts in the community did not stop. at the time of this outbreak, the rate of mmr vaccination in the community was 54%. it dropped further. in 2017, the second and bigger outbreak happened. an unvaccinated child from the first case infected others. at the end of the day, there were seventy-five cases in this outbreak. sixty-one of them were young somali children. most of these children were unvaccinated. twenty-one of the children, many of them toddlers, were hospitalized.4 at the time when the anti-vaccine groups began speaking to the somali community, there were already a lot of studies asking whether mmr causes autism. a large study in denmark found no difference in rates of autism between children who got the mmr vaccine and children who did not. similarly, a study of over 500,000 children in finland found no link either.5 a smaller study in the united kingdom and a large study in japan also found no link.6 further, a study in canada found no link.7 so, at the point we are talking about, there were already a lot of studies that looked at whether mmr causes autism. even before the 2017 outbreak, a study in the united states looked at 95,000 children and found no link between mmr and autism.8 for completion, i will add that another large study from denmark found no link between the two.9 so, you can say quite reasonably that the claim that mmr causes autism, at that point, was strongly disproved by many cities around the world. however, misinformation was intentionally spread in communities by anti-vaccine groups. as a result, mmr vaccination rates dropped, and outbreaks put children in the hospital. 2. dorit rubinstein reiss & john diamond, measles and misrepresentation in minnesota: can there be liability for anti-vaccine misinformation that causes bodily harm?, 56 san diego l. rev. 531, 532 (2019). 3. id. at 551. 4. id. at 552. 5. annamari ma@kela@ et al., neurologic disorders after measles-mumps-rubella vaccination, 110 pediatrics 957, 957 (2002). 6. brent taylor et al., autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association, 353 lancet 1985, 2026 (1999); hideo honda et al., no effect of mmr withdrawal on the incidence of autism: a total population study, 46 j. child. psychol. psychiatry 561, 572 (2005). 7. eric fombonne et al., pervasive developmental disorders in montreal, quebec, canada: prevalence and links with immunizations, 118 pediatrics e139, e139-40 (2006). 8. anjali jain et al., autism occurrence by mmr vaccine status among us children with older siblings with and without autism, 313 jama 1534, 1534 (2015). 9. anders hviid et al., measles, mumps, rubella vaccination and autism: a nationwide cohort study, 170 annals internal med. 513, 513 (2019). 2021] anti-vaccine misinformation and the law 87 when someone spreads misinformation that can be linked to disease, what can we do? since i am a law professor, i will talk about the legal tools for this. the first tool for responding to misinformation is not a legal tool. it is education, which includes providing correct information and debunking misinformation. law is another set of tools. it is important to have a lot of tools in your toolbox. now, i am going to set out a number of tools that you can use. however, just because you can does not always mean that you should. although we have legal tools available for when misinformation causes an outbreak or a disease, it is not always right to use them. sometimes it will be appropriate, and sometimes it will not. right now, i am going to talk about if we can use legal tools. whether we should is a policy question on the ground for the right case. so, what can we do? what tools do we have? the first potential claim i want to cover is the claim of misrepresentation or fraud.10 intentional misrepresentation or fraud first requires that you show a material misrepresentation, meaning you knew or recklessly disregarded something. reckless disregard does not mean that you just were very negligent. it means that there are grounds to think that you had a suspicion that it was fraud or that you intentionally ignored information that something was wrong. knowledge or reckless disregard as to its truth or falsity is the second requirement. intent to induce reliance is the third requirement. justifiable reliance by the victim is the fourth requirement, and pecuniary damages by the victim are the final requirement. remember, there are two kinds of claims that you can bring here. one is a claim for someone who did not vaccinate or was infected by someone who did not vaccinate for physical harm. the other claim is a claim of costs by the department of health. i want to point out something. many anti-vaccine groups or individuals sincerely believe in the information that they provide. so, many of the people that claimed mmr caused autism probably believed that. they did not know that the information was false. and, while you can say that they were at least negligent for ignoring many studies, they sincerely believed that what they were saying was true. so, this is a tricky claim to make. another issue that i want to point out is whether we have justifiable reliance by the victim. if your doctor tells you that you should vaccinate your child with mmr and an anti-vaccine organization tells you that you should not, is it justifiable to rely on what the anti-vaccine organization said over what your doctor said? not necessarily. finally, another problem with misrepresentation or fraud is that it is focused on financial damages, rather than physical damages. on the other hand, you may ask whether you can use intentional misrepresentation for the costs to the department of health. the department of health is claiming that the anti-vaccine organization misrepresented information. and, as a result, it lost money because it had to put in costs to address the public health issue. this was actually tried by funds for tobacco. as you hopefully know, tobacco companies were shown to misrepresent quite a bit of information. 10. see reiss & diamond, supra note 2. 88 indiana health law review [vol. 18:85 specifically, they hid or misrepresented information about how addictive and harmful cigarettes were. in the 1970s and 1980s, a lot of actors and hedge funds tried to take tobacco companies to court. one such case is new jersey carpenters health fund v. philip morris, inc.11 such was addressed in the district court of new jersey in 1998. in new jersey carpenters health fund, the claim was that the tobacco companies committed intentional misrepresentation against the health fund by misrepresenting information to people who smoked tobacco. the problem with that claim was that the court said that the tort of intentional misrepresentation was to protect the victim from misinformation, not third parties or those who had later costs from misinformation. therefore, the courts routinely rejected these kinds of claims by health funds. so, trying to sue through the department of health using intentional misrepresentation may be unsuccessful. it is important to note that such is not a one-to-one because the health funds were also suing as the health insurer. health departments are not quite in that role. however, the same logic that led courts to say that the health funds were too remote from intentional misrepresentation should lead to the courts saying that the health departments cannot sue for the public cause here. another potential claim, especially relevant to the people who got sick as a result of the anti-vaccine misinformation, is intentional misrepresentation that risks physical harm. this is embodied in section 310 of the restatement (second) of torts.12 it has not been adopted in the restatement (third) of torts yet. nonetheless, the restatement (second) of torts has this option. it says that if you misrepresent something, you can be held liable for physical harm if you intended for your statement to induce reliance, you knew that the statement was false, or you knew that you did not have the knowledge which you professed. on one hand, we are running into the same problem we ran into when we talked about intentional misrepresentation in the economic sphere. anti-vaccine people generally believe what they are saying. so, they do not know that the statement is false. they might know that other things are statements thought, but they do not know that the statement is false. you can ask whether they know that they do not have the knowledge that they profess. however, that can also be tricky to show. for example, if an anti-vaccine activist believes that he knows something that a doctor does not, then he does not know that he lacks the knowledge. remember, this is an intentional tort. you need to have subjective intent, and that will be really hard to show here. another potential claim that does not have the problem of intentional torts is a public nuisance scheme. public nuisance has been used in the public health context in a number of areas.13 it has been used to bring state claims against lead 11. new jersey carpenters health fund v. philip morris, inc., 17 f. supp. 2d 324 (d.n.j. 1998). 12. restatement (second) of torts § 310 (am. law inst. 1965). 13. lindsay f. wiley, rethinking the new public health, 69 wash. & lee l. rev. 207, 238 (2012). 2021] anti-vaccine misinformation and the law 89 paint manufacturers. it has been used to bring claims against tobacco companies. unreasonable interference with something common to the public, such as public health, is at the heart of public nuisance. it is not impossible to think about the health department bringing a claim against a public health organization based on a public nuisance. but there are some barriers. one barrier is that, in the cases where it has been used in the past, public nuisance was used against a company that was creating a product. now, you can say that there is nothing in the tort that is only directed against for-profit companies. that is fair. however, information is not the same as physical products. information is harder to contain. it is closer to the realm of speech than the realm of conduct. therefore, this might be a tricky tool to use for misinformation by itself. that said, we do have a past of using this in the public health context, and that might help. also, public nuisance is now being used in climate change.14 several lawsuits on climate change or the opioid crisis are trying to use public nuisance. this is closer to the product area than misinformation. § earlier we saw section 310 of the restatement second of torts, which was about intentional misrepresentation that causes physical harm. on the other hand, section 311 of the restatement second of torts is about negligent misrepresentation that causes physical harm to another.15 so, you do not have to show that the person promoting the misinformation knew that it was false. for section 311, you first have to have a negligent misrepresentation. in terms of the minnesota outbreak, you would probably have a strong misrepresentation claim since there were many studies that showed that the mmr vaccine was not linked to autism. also, you can probably claim that it was negligent to say given that there was a global consensus that the mmr vaccine did not cause autism. so, you can show negligent misrepresentation. as i said earlier, you have the following question: is it reasonable to rely on misinformation by anti-vaccine groups, rather than on what a doctor says? this is the second element for negligent misrepresentation that causes harm to another. in the minnesota case, there is probably a good argument for reasonable reliance. in that case, you have anti-vaccine people who are very well-educated and wellspoken come in. also, they brought dr. andrew wakefield with them. wakefield was a british gastroenterologist. he lost his license and suffered other consequences after a study he published, which implied that there was a link between the mmr vaccine and autism, was fraudulent. though, his loss of the license was not due to the fraudulent study. it was due to his concealment of conflicts of interests, a couple of untrue statements, and performing invasive tests on children without good cause. nevertheless, when wakefield spoke to the minnesota community, he appeared as a doctor and was well-spoken. therefore, it might be reasonable to rely on him. other speakers in the community also sounded like they knew what 14. see victor flatt & richard o. zerbe, climate change common law nuisance suits, 49 envtl. l. 683 (2019). 15. restatement (second) of torts § 311 (am. law inst. 1965). 90 indiana health law review [vol. 18:85 they were saying. so, when you have a group of people who appear to know what they are saying, it might be reasonable to rely on them. the third element of negligent misrepresentation that causes physical harm is that you have to show physical harm as a result. for the minnesota case, this is easy. the measles outbreak hospitalized many kids. further, the fourth element is that you have to show a duty of care. in that sense, they collapse this tort with regular negligence for the purpose of misinformation. so, you have to show a duty. a duty can be created by your actions or by the relationship between you and the party. accordingly, these cases were looking for a relationship between the speaker and the recipient of information that was closer than the general public just getting information. finally, the courts are also concerned about first amendment limits. this is the fifth and final element. when we are talking about misinformation, we are talking about speech. the first amendment protects freedom of speech, but you do have tort liability for speech offenses in some cases. therefore, in those cases, where do you draw the line? the courts, convincingly, drew the line by saying that there is an area where you have a duty. as a result, the first amendment is probably weakened when you show both the duty and the misrepresentation. basically, we are looking for this overlap. the goal of the courts is not to have too expansive of a tort. there are at least three concerns that they have with this tort. first, there is a first amendment concern. the courts say we would rather err on the side of more speech rather than less. tort liability could chill speech and impose consequences on it. second, courts are worried about expansive liability. generally speaking, negligence is not intent. it is less culpable, and the courts say that we are not going to allow unlimited liability when we are talking about languages. the problem with information is that it is spread easily. so, if you say something that is not true, it can spread very broadly and liability can easily become unmanageable. finally, the courts felt unable to distinguish misinformation from things that are not quite misinformation. so, they are cautious there. in our paper, we suggest two principled ways to allow the tort to operate in some cases but still remain limited so as to not jeopardize the first amendment or lead to unlimited liability. here is our suggestion. we think it is appropriate to impose liability on misinformation that causes harm, including outbreaks in some cases but not in others. the first limit we would impose depends on the relationship. we think it is more justified to impose liability when you have a one-on-one situation or when you are getting near a one-on-one situation. however, you also have mass media. for example, what happens when you are dealing with a small group? let’s say an anti-vaccine group brings in a speaker and has an audience of sixty people. is it a private consult or mass media like the internet? there is some vagueness here and some areas where this will be harder to apply. so, why do we think that this is a good standard? first of all, if you are speaking to someone one-on-one, you kind of see who is relying on you. you expect that the people you are trying to convince will rely on you when you are speaking to them face-to-face. when you are cultivating someone or in a relationship of consultation, you know that they are going to rely on you or at 2021] anti-vaccine misinformation and the law 91 least you hope that they are going to rely on you. therefore, you know who is relying on you. so, it is easier to say that you are liable because you looked them in the eye, told them something that was not true, and they got hurt. on the other hand, when you post on the internet, you do not know who is reading your post. you do not know if there are reasonable grounds to expect that a person will rely on your post. so, you might argue that the person should fact check what you said, even if you think it is true. after all, you are not a doctor. the liabilities for private consults and small groups are well-defined. the same cannot be said for mass media. when you put something on the internet, many people can read it and liability can easily balloon. also, duty is often found when there is a relationship. so, this fits with what we do in other areas, and we do look for consistency in the law. we would like to have a similar approach across all areas. however, there are some problems with this approach. one problem is that, in a sense, you are rewarding the people who reached a larger audience. you are saying that because their misinformation went so broadly, they are off the hook. that is jarring. maybe the person who misled more people should have a higher penalty and not be off the hook? it is also not directly related to the other elements of the tort of misrepresentation and so forth. but still, because we care about freedom of speech and worry about a not overextending liability, this gives us a principled way to draw some lines. when an anti-vaccine organization comes into a community and targets small groups, we are more likely to find liability on them. obviously, the law does not necessarily stop with one line. in imposing liability, in addition to the core continuum here, it is probably reasonable to also consider the level of culpability. if someone was very close to lying intentionally, we can treat them more severely than if it was an unreasonable and understandable error. so, culpability matters and should be taken into account. the second factor is much trickier: how sophisticated is a target? this is trickier because it is very easy to insert bias into this element. when we are talking about very young children, we can say that their lack of sophistication makes us want to protect them more. therefore, we will more easily find liability when children are targeted. however, once you move beside that, there is a danger. the minnesota outbreak shows this danger very well. if we are saying that the somali community was less sophisticated, are we engaging in bias? we probably are to some degree. on the other hand, there is a good argument that, in terms of knowing who to rely on in the country, immigrant communities are more vulnerable than native communities. though, we need to be very cautious in addressing the sophistication of a target. i think it is relevant, but i would be really cautious in applying it. everything i have said so far probably applies to some types of information and not to others. for example, in product liability, we have a tradition of penalizing and imposing liability on bad warnings for instructions. this is speech. however, instructions describe how to use a product. and, when you are describing how to use a product, you are getting closer to conduct and farther away from speech. therefore, we would not be as worried about freedom of speech, and we would be able to impose liability if your instructions were negligent and caused a harm. 92 indiana health law review [vol. 18:85 sponsored activity is even farther away from speech. an example of a sponsored activity is organizing a competition or a course. in a course, you are giving information. however, organizing a course is also an activity. if you manage a course in a way that puts people in danger because of how it is managed, such is closer to activity than speech. moreover, engaging in speech about what is dangerous is where we really want to be cautious and impose a liability in certain circumstances. we do not want to impose liability in all circumstances because a lot of speech can suggest dangers, and we want issues to be debated and exposed to the marketplace of ideas. if we are quick to impose liability, new ideas might face higher barriers. so, negligent misrepresentation that causes harm is a viable option for tort liability in some cases. however, we are going to want to be careful. if somebody gives instructions, we can probably be pretty comfortable in imposing liabilities on instructions that were negligently false. if someone is just talking about riskbenefit, we are probably more likely to impose liability if the context is a consultation and not a mass media context. what else can we do? we could consider reducing the protections for social media companies against liability. right now, under section 230 of the communication decency act, social media companies are protected from liability for civil liability.16 we could reduce that. for example, if facebook put out antivaccine misinformation and someone got hurt, it could be liable. that is a little tricky in two ways. first, it can really limit what social media companies can do. facebook has over a billion users. regulating all of those users is probably not feasible in real-time. there are going to be limits to what facebook can do. also, civil liability may mean that facebook would completely shut down scenarios of discussion. that is not necessarily a good thing. second, we are penalizing facebook for things where other people are more culpable. we are not cutting the promoters of misinformation out. another tool we may want to consider using is no-fault options. in an earlier paper, we wrote about the ability to impose taxes or fees on people who do not vaccinate.17 the logic is that even if we ignore fault, people who choose not to vaccinate are choosing to impose costs on others. requiring them to internalize that cost can change their behavior and lead to a more equitable result as they will cover the costs that they would impose on others. this can include a fee for not vaccinating that would go into a special fund. the fund would cover the costs of people who are infected by unvaccinated individuals or the cost to the health department. this can also include a tax on not vaccinating. similarly, such would go to a fund. further, tax breaks could be offered to people who vaccinate. we can also consider increasing insurance payments. however, there is a legal problem here, which is that the affordable care act limits what you can impose a premium for. so, to allow this to happen, you would actually have to change the affordable care act. alternatively, you can give an insurance 16. 47 u.s.c. § 230 (2020). 17. see charlotte a moser et al., funding the costs of disease outbreaks caused by nonvaccination, 43 j.l. med. & ethics 633 (2015). 2021] anti-vaccine misinformation and the law 93 discount to people who do vaccinate. there is a legal path to do this because the affordable care act does allow the reduction of premiums for wellness plans. the other way to go about using a no-fault issue is after the fact. you can bill or fine people who do not vaccinate if such causes an outbreak. there is nothing unconstitutional or illegal with this approach. in fact, this idea was modeled on an arizona law, which says that the state can bill people if they knowingly go to a flood area, get caught there, and call for help. the same approach can be taken with non-vaccination. however, can you also do this for misinformation – not for the people who do not vaccinate but for the people who spread misinformation? doing this would be a little tricky due to the first amendment. you would be billing these people for the effect of their speech. nonetheless, i think there is a good case for doing this for two reasons. first, if the organization directly discouraged people from vaccinating, such would be an instruction. we penalize people for instructions. this is not a freedom of speech issue because instructions are very close to conduct. on the other hand, if an anti-vaccine advocate says that you can vaccinate your child, but also tells you that horrible things will happen to your child if you do, this is closer to negligent misrepresentation. you would probably be able to bill the antivaccine advocate, and you would be more likely to survive first amendment scrutiny for a one-on-one consultation scenario. now, let’s pull it back to covid-19. so far, my main example has been antivaccine efforts in minnesota. what is going on with covid-19? you have probably noticed that there is a lot of misinformation about covid-19. i want to split that misinformation into two kinds of misinformation. one type of misinformation tries to convince people how to treat covid-19. in the pretty early days, an anti-vaccine group recommended vitamin c, hyperbaric oxygen treatment, and zinc to cure covid-19. similarly, another anti-vaccine group recommended hydroxychloroquine and vitamin c as covid-19 cures. now, remember, the fda recently revoked the emergency-use authorization for hydroxychloroquine because increasing evidence suggests that it does not do anything for covid-19. during the early days, there may have been reason to think that it could have, but now we are at the point where the data does not support that thought. if you promote a cure and someone uses that cure, there can be one of two results. result one, the cure can harm the person. for example, hydroxychloroquine can harm you and cause a heart attack. result two, the cure does not directly hurt you, but it also does not help you. you have been given false hope, which may make you less cautious and less avoiding of covid-19. the first result is probably much easier to address legally than the second. under the first scenario, we are directly harmed by something that someone presented to us as a cure. at the very least, you can say that someone who promoted vitamin c as a cure for covid-19 was acting without evidence, against the expert advice, and probably negligently. hyperbaric oxygen treatment even more so. that is a treatment for people who have deep water sickness and not covid-19. as for the cure not protecting you, that is going to be a lot harder to prove. first, if the issue is “i was not as careful and got covid-19 because i trusted that 94 indiana health law review [vol. 18:85 there was a cure,” well, i could have gotten covid-19 anyway. causation is going to be an issue. second, relying on a magic cure that experts recommend against might be seen as unreasonable reliance. so, that is one set of potential claims and their challenges. i am going to use my last few minutes to address the different types of claims we are hearing about covid-19, including that it is not dangerous or that you do not need to wear a mask. so, candace owens, who is a political activist, suggested that covid-19 deaths are fake. here is one of her tweets. she suggests the number of people dying from covid-19 is false. can you do anything about this? the risk here is that if you convince people that coronavirus is not dangerous, then a person might not be as careful. this would be a hard claim. first of all, even if you are careful, you can still catch covid-19. you could, however, claim that taking more precautions would reduce your risk. though, this is really going to be very heavily fact-dependent. second, is relying on a tweet by a person who is not a doctor reasonable? again, you run into a problem. this is not an instruction. candace owens is not telling you to go out and catch covid19. she is saying that the deaths from covid-19 are fake and that it is not that big of a deal. contrast this with an anti-vaccine leader who is encouraging people to catch covid-19. the anti-vaccine leader has a whole set of claims. he suggests that the people who die from covid-19 smoked, did not eat well, or were not in good health. further, he argues that covid-19 is just a common cold and that people need to go out to catch it. this is different because it is an instruction. the anti-vaccine leader is telling people to seek the virus. if you go out, catch covid-19, and are harmed or infect someone else, then this is a good argument for misrepresentation that caused bodily harm. the only question will be: is it reasonable to rely on an anti-vaccine activist without relevant training? you could argue that he seemed convincing. he spoke with passion. a lot of people listen to him. the argument might be hard, but it is possible. and we will stop here. will neuroscience redefine mental injury? disability benefit law, mental health parity law, and disability discrimination law stacey a. tovino, jd, phd∗ i. introduction .................................................................... 695 ii. disability benefit law ................................................. 697 iii. mental health parity law .......................................... 706 iv. disability discrimination law .................................... 720 v. conclusion ...................................................................... 727 i. introduction within the overlapping fields of neurolaw and neuroethics, scholars have given significant attention to the implications of advances in neuroscience for issues in criminal law,1 criminal procedure,2 constitutional law,3 law and religion,4 tort law,5 evidence law,6 confidentiality and ∗ lehman professor of law and director, health law program, william s. boyd school of law, university of nevada, las vegas. 1 see stephen j. morse & adina l. roskies, a primer on criminal law and neuroscience (2013). 2 see sarah e. stoller & paul root wolpe, emerging neurotechnologies for lie detection and the fifth amendment, 33 am. j.l. & med. 359 (2007). 3 see federico gustavo pizzetti, in quest of constitutional principles of “neurolaw,” 23(3) med. secoli. 963 (2011). 4 see, e.g., steven goldberg, neuroscience and the free exercise of religion, in law and neuroscience: current legal issues (2011). 5 see betsy j. grey, neuroscience and emotional harm in tort law: rethinking the american approach to free-standing emotional distress claims, in law and neuroscience: current legal issues 203 (michael freeman ed., 2011); shaun cassin, eggshell minds and invisible injuries: can neuroscience challenge longstanding treatment of tort injuries? 50 hous. l. rev. 929 (2013). 6 see stephen j. morse, neuroimaging evidence in law: a plea for modesty and relevance, in neuroimaging in forensic psychiatry: from the clinic to the courtroom 341 (joseph r. simpson ed., 2012) http://dx.doi.org/10.18060/3911.0006 696 indiana health law review vol. 12:2 privacy law,7 protection of human subjects,8 and even the regulation of neuroscience-based technologies.9 less attention has been paid, however, to the implications of advances in neuroscience for more traditional civil and regulatory health law issues.10 in this article, based on my presentation made at the indiana university robert h. mckinney school of law, hall center for law and health/indiana health law review symposium titled “will neuroscience redefine mental injury,” i wanted to provide an update regarding the ways in which neuroscience impacts three different areas within civil and regulatory health law, including public and private disability benefit law, federal mental health parity law, and federal and state disability discrimination law.11 because the conference (reviewing evidentiary concepts such as admissibility, relevance, and standards of proof as they relate to the possible uses of neuroimaging findings in legal proceedings”). 7 see stacey a. tovino, functional neuroimaging information: the case for neuroexceptionalism? 34 fla. st. u. l. rev. 415 (2007). 8 see, e.g., james a. anderson et al., neuroethical issues in clinical neuroscience research, in ethical and legal issues in neurology: handbook of clinical neurology series 335 (james l. bernat & richard beresford eds., 2013); stacey a. tovino, a “common” proposal, 50 hous. l. rev. 787 (2013). 9 see henry t. greely, neuroscience-based lie detection: the need for regulation, in using imaging to identify deceit: scientific and ethical questions 46 (emilio bizzi et al. eds., 2009). 10 see stacey a. tovino, neuroscience and health law: an integrative approach? 42 akron l. rev. 469, 472 (2009) (stating, “little attention has been paid, however, to the implications of advances in neuroscience for more traditional civil and regulatory health law issues”; exploring the ways in which neuroscience impacts a range of health, disability, and benefit law issues, including the scope of public and private health insurance benefits, the mental health parity debate, protected status under federal and state disability law, and the distribution of benefits under social security and other benefit programs). 11 my presentation brought together themes and arguments that i have made in a number of prior publications. see, e.g., stacey a. tovino, the dsm-5: implications for health law, 2015 utah l. rev. (forthcoming 2015); stacey a. tovino, lost in the shuffle: how health and disability laws hurt disordered gamblers, 89 tulane l. rev. 191 (2014); stacey a. tovino, insurance and parity laws, in mental health care issues in america: an encyclopedia, vol. i, 350-57 2015 will neuroscience redefine mental injury? 697 organizers asked the speakers to think about how advances in neuroscience provide insights that might challenge the physical-mental dichotomy,12 i particularly wanted to focus on: (1) whether the laws in these three areas provide fewer or otherwise different benefits for individuals with mental versus physical injuries, diseases, and disorders; and, if so (2) whether neuroscience is being used to confront these different benefit sets. ii. disability benefit law the first area on which i wanted to focus is disability benefit law. disability benefits can be public, such as the cash disability benefits provided by the social security administration (ssa) to individuals who meet the ssa’s definition of disability.13 disability benefits can also be private, such as the cash disability benefits provided by (michael shally-jensen ed., 2013); stacey a. tovino, a proposal for comprehensive and specific essential mental health and substance use disorder benefits, 38 american j.l. & med. 471 (2012); stacey a. tovino, all illnesses are (not) created equal: reforming federal mental health insurance law, 49 harv. j. on legis. 1 (2012); stacey a. tovino, further support for mental health parity law and mandatory mental health and substance use disorder benefits, 21 annals health l. 147 (2012); stacey a. tovino, reforming state mental health parity law, 11 houston j. health l. & pol'y 455 (2011); tovino, neuroscience and health law: an integrative approach, supra note 10, at 469; stacey a. tovino, the impact of neuroscience on health law, 1 neuroethics 101 (2008). as such, the discussions of disability benefit law, mental health parity law, and disability discrimination law found in this article are also available in whole or in part in the publications listed above and are taken with permission by the author. 12 events: hall center for law and health conference, will neuroscience redefine mental injury? indiana university robert h. mckinney school of law (oct. 4, 2013) available at http://mckinneylaw.iu.edu/events/current.cfm?eid=162 (stating, “legal systems have traditionally treated physical and mental injuries differently. advances in neuroscience provide insights that challenge this dichotomy. this multidisciplinary half-day conference will examine some of the evolving technologies used to demonstrate mental injury and explore the potential impact of this neuroscientific data in legal decision making.”). 13 see infra notes 15-26. http://dx.doi.org/10.1007/s12152-008-9010-z 698 indiana health law review vol. 12:2 administrators of shortand long-term disability insurance plans to individuals who participate in such plans as a benefit of employment or who purchase such plans on the open insurance market.14 with respect to public disability benefits, title ii of the ssa provides for the payment of federal social security disability insurance (ssdi) benefits to individuals with both physical and mental disabilities.15 indeed, the ssa defines “disability” as the “inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment.”16 an applicant’s impairment or impairments must be “of such severity that he is not only unable to do his previous work but cannot, considering his age, education, and work experience, engage in any other kind of substantial gainful work which exists in the national economy.”17 the applicant’s impairment must last or be expected to last for a continuous period of at least twelve months, or be expected to result in death.18 the commissioner of social security (commissioner) has established a five-step sequential evaluation for determining whether an individual has a disability that qualifies for the receipt of ssdi benefits.19 first, a 14 disability income insurance protects an individual’s income. if an individual becomes unable to work due to a sickness or injury, disability income insurance provides cash benefits that the individual may use to pay for housing, food, clothing, and utilities, among other living expenses. designed to provide financial security until the individual returns to work, disability income insurance typically pays a monthly cash benefit after an initial waiting period that is equivalent to a percentage of the individual’s salary. see, e.g., mass mutual financial group, disability income insurance, https://www.massmutual.com/sem/disabilityinsurance?cm_mmc=google-_-disability_nb-_-ppc-_-60777225-vq16-c (last visited august 11, 2015). 15 see, e.g., locher v. sullivan, 968 f.2d 725, 727 (8th cir. 1992). 16 42 u.s.c. § 423(d)(1)(a) (2013). 17 id. § 423(d)(2)(a). 18 id. § 423(d)(1)(a). 19 20 c.f.r. § 404.1520(a)(4) (2013) (listing the five-step sequential evaluation process); id. § 416.920(a)(4) (explaining the five-step sequential evaluation process); bowen v. yuckert, 482 u.s. 137, 140-42 2015 will neuroscience redefine mental injury? 699 determination is made regarding whether the individual is engaged in “substantial gainful activity.”20 if so, benefits are denied.21 second, if the individual is not engaged in substantial gainful activity, a determination is made regarding whether the individual has a medically severe impairment or combination of impairments.22 if the individual does not have a severe impairment or combination of impairments, benefits are denied.23 third, if the individual has a severe impairment, a determination is made regarding whether the impairment meets or equals one of a number of “listed impairments” in 20 c.f.r. part 404, subpart p, appendix 1. if the impairment meets or equals a “listed impairment,” the individual is conclusively presumed to have a disability.24 fourth, if the impairment does not meet or equal a “listed impairment,” a determination is made regarding whether the impairment prevents the individual from performing past relevant work. if the individual can perform past relevant work, benefits are denied.25 fifth, if the individual cannot perform past relevant work, the burden shifts to the commissioner to show that the individual is able to perform other kinds of work. the individual is entitled to ssdi benefits only if the person is unable to perform other work.26 in addition to public ssdi benefits, private disability income insurers also offer private disability income insurance plans. these plans provide shortand long-term cash benefits to individuals who become disabled. private disability benefits are governed not by the five-step sequential analysis set forth in federal law, above, but by the terms of the plan itself.27 as discussed in more detail (1987) (u.s. supreme court opinion explaining the five-step sequential evaluation process in the context of a particular claimant). 20 20 c.f.r. § 416.920(a)(4)(i) (2013). 21 id. 22 id. § 416.920(a)(4)(ii). 23 id. 24 id. § 416.920(a)(4)(iii). 25 id. § 416.920(a)(4)(iv). 26 id. § 416.920(a)(4)(v). 27 see, e.g., mcdonald v. western-southern life ins. co., 347 f.3d 161, 163 (6th cir. 2003) (interpreting the western and southern life 700 indiana health law review vol. 12:2 below, private disability benefit plans typically provides fewer disability insurance benefits to individuals with mental versus physical disabilities. in addition, litigants with mental disabilities are using neuroscience to confront these different benefits. reid v. metropolitan life insurance co. is a relatively recent case out of the northern district of georgia that may be used to illustrate these principles and findings.28 in reid, defendant metlife administered a long-term disability plan (plan) that distinguished between physical and mental disabilities by providing long-term disability benefits for participants with permanent physical disabilities but only two years of disability benefits for participants with “mental or nervous disorders or diseases.”29 the plan further excluded certain organic mental disorders, such as dementia, from the list of “mental or nervous disorders or diseases” and treated them like physical disabilities, eligible for long-term disability benefits.30 the claimant in the case, ms. reid, began in 2001 experiencing certain behavioral and other changes, including spending too much money on jewelry, difficulty in formulating words and thoughts, difficulty in processing information and making decisions, sleeping problems, and memory problems.31 a former employee of plan sponsor international business machines corporation (ibm), ms. reid filed a claim for long-term disability benefits in 2007.32 metlife approved ms. reid’s disability benefits in 2008, but only for twenty-four months.33 metlife reasoned that ms. insurance company flexible benefits plan’s (plan’s) long-term disability provisions, including the plan’s definition of “long-term disability or long-term disabled” and noting that, pursuant to the terms of the plan, covered employee’s have the obligation to furnish proof of any long-term disabilities). 28 reid v. metropolitan life ins. co., 944 f.supp.2d 1279 (n.d. ga. 2013). 29 id. at 1282. 30 id. 31 id. at 1283-85. 32 id. at 1285. 33 id. at 1289. 2015 will neuroscience redefine mental injury? 701 reid suffered from a mental, not a physical, disability.34 in 2011, ms. reid filed a lawsuit against metlife in the u.s. district court for the northern district of georgia under the employee retirement income security act of 1974 (erisa).35 in the lawsuit, ms. reid sought to recover longterm disability benefits.36 the legal issue before the court was whether ms. reid had a mental diagnosis of bipolar disorder, depression, and/or attention-deficit hyperactivity disorder (adhd), which would limit her to just twenty-four months of disability benefits, or whether her primary diagnosis was dementia, which would make her eligible for long-term disability benefits.37 of course, ms. reid argued that she had dementia, a physical disability.38 metlife took the position that ms. reid had bipolar disorder, a mental disability.39 in a wonderfully detailed, forty-nine page judicial opinion, district judge amy totenberg thoroughly analyzed a number of medical opinions regarding the proper classification of ms. reid’s disability.40 in ms. reid’s earlier medical records, her treating physicians had diagnosed her with bipolar disorder, depression, and/or adhd in light of behaviors such as spending too much money on jewelry.41 in ms. reid’s later medical records, her treating physicians diagnosed her with dementia in light of her significant memory problems, difficulty formulating words and thoughts, and difficulty processing information and making decisions.42 metlife’s three independent physician consultants, each of whom completed a single review of ms. reid’s file and never personally examined ms. reid, reported that ms. reid suffered from bipolar disorder.43 34 id. 35 id. at 1282. 36 id. 37 id. at 1285-98. 38 id. 39 id. at 1298. 40 id. at 1279-1327. 41 id. at 1285. 42 id. at 1292, 1315-16. 43 id. at 1316. 702 indiana health law review vol. 12:2 after carefully reviewing all of ms. reid’s medical records and all of the treating and consulting physician reports, judge totenberg ultimately sided with ms. reid’s later treating physicians and found that ms. reid had dementia, thus making her eligible for long-term disability benefits.44 did neuroscience aid judge totenberg in her decision? the answer is yes. judge totenberg placed remarkable weight on a structural magnetic resonance image (mri) of ms. reid’s brain. in 2007, one of ms. reid’s treating physicians ordered an mri to rule out organic causes of her symptoms.45 according to the physician who interpreted the mri, ms. reid had “moderate to severe cerebral atrophy, worse for the occipital lobes bilaterally.”46 judge totenberg relied on that interpretation; indeed, she stated that ms. reid’s dementia was “confirmed by her neuroimaging results showing cerebral atrophy.”47 judge totenberg ultimately held that metlife’s failure to consider the mri as evidence of dementia was not only de novo wrong but also arbitrary and capricious.48 the reid case is an excellent illustrator of how private disability benefit plans distinguish between physical and mental disabilities and provide fewer benefits for individuals with mental disabilities. the case also illustrates how litigants and judges are using neuroimaging to confront the somewhat artificial distinctions between physical and mental disabilities. i chose the reid case for discussion not only for these reasons, but also because judge totenberg actually addressed the legal distinctions between physical and mental disabilities. indeed, judge totenberg quoted the preface to the american psychiatric association’s (apa) then-current edition of the diagnostic 44 id. at 1315-16. 45 id. at 1285. 46 id. at 1286-87. 47 id. at 1323. 48 id. at 1280, 1315-16 (stating, “the court finds dr. stallings’ opinions, based on an eight-year treating relationship with plaintiff and dr. carstens’s reports, the mri results, and repeated neurological testing results to be far more reliable than the opinions of met-life’s three ipc’s whose opinions were each based on a single file review.”). 2015 will neuroscience redefine mental injury? 703 and statistical manual of mental disorders (dsm-iv) to explain that: [t]he term mental disorder unfortunately implies a distinction between “mental” disorders and “physical” disorders that is a reductionistic anachronism of mind/body dualism. a compelling literature documents that there is much “physical” in “mental” disorders and much “mental” in “physical” disorders. the problem raised by the term “mental” disorders has been much clearer than its solution, and, unfortunately, the term persists in the title of dsm-iv because we have not found an appropriate substitute.49 that is, judge totenberg correctly recognized that the plan was forcing her to make a decision regarding whether ms. reid had a physical or mental disability even though the apa itself believes that there is much physical in mental and much mental in physical and that no definition of “mental disorder” could adequately specify precise boundaries between the physical and mental. i also liked how judge totenberg recognized that a clinical diagnosis of a mental disorder under the dsm-iv generally is not sufficient to establish the existence for legal purposes of a mental disability: when the dsm-iv categories, criteria, and textual descriptions are employed for forensic purposes, there are significant risks that diagnostic information will be misused or misunderstood. these dangers arise because of the imperfect fit between the questions of ultimate concern to the law and the information contained in a clinical diagnosis. in most situations, the clinical diagnosis of a 49 id. at 1305-06. the fifth edition of the diagnostic and statistical manual (“dsm-5”) is the current edition but the dsm-iv was current at the time of the facts giving rise to the reid case. 704 indiana health law review vol. 12:2 dsm-iv mental disorder is not sufficient to establish the existence for legal purposes of a “mental disorder,” “mental disability,” “mental disease,” or “mental defect.” in determining whether an individual meets a specified legal standard (e.g., for competence, criminal responsibility, or disability), additional information is usually required beyond that contained in the dsm-iv diagnosis. this might include information about the individual’s functional impairments and how these impairments affect the particular abilities in questions.50 because the metlife plan at issue defined mental disability entirely in terms of the dsm-iv,51 judge totenberg based her legal decision on whether ms. reid met the manual’s diagnostic criteria for dementia.52 judge totenberg correctly recognized, however, that the apa designed the manual for use by clinicians in the clinic, not for judges and lawyers in the courtroom.53 stated another way, judge totenberg seemed to be suggesting that private disability plans’ heavy reliance on the dsm-iv might be displaced given the different objectives of law and medicine. the reid case involved a claim for private disability benefits. claims for public disability benefits are somewhat different. as discussed above, federal law does not on its face discriminate against claimants with mental disabilities by providing less comprehensive disability income insurance benefits for individuals with mental disabilities compared to 50 id. at 1307. 51 see id. at 1282 (referencing the plan provision stating that “mental or nervous disorder or disease means a medical condition which meets the diagnostic criteria set forth in the most recent edition of the diagnostic and statistical manual of mental disorders as of the date of your disability.”). 52 id. at 1308-11. 53 id. at 1306 (“the diagnostic categories, criteria, and textual descriptions are meant to be employed by individuals with appropriate clinical training and experience in diagnosis. it is important that dsmiv not be applied mechanically by untrained individuals.”). 2015 will neuroscience redefine mental injury? 705 individuals with physical disabilities.54 as applied, however, federal law can make it more difficult for individuals who claim that they have a mental disability to prove that disability because federal law requires the impairment to be “medically determinable.” as one might imagine, historically it has been easier for claimants to use radiologic, laboratory, and other diagnostic tests to prove a physical disability compared to a mental disability.55 for example, a computed tomography (ct) and other brain scans can be used to diagnose certain types of physical (traumatic) brain injuries. on the other hand, individuals with major depression, bipolar disorder, and schizophrenia historically have not had access to a similar radiologic diagnostic tool. however, advances in neuroimaging may be making it slightly easier for individuals to prove their mental disabilities. for example, ssdi claimants are now offering neuroimaging evidence as confirmatory evidence of their mental disabilities and some courts are accepting the confirmation provided by such evidence. for example, one ssdi claimant with alcohol dependence submitted to the ssa a neuroimage that was interpreted to reveal alcoholic cortical atrophy, which correlated with dementia and impaired capacity to work.56 the reviewing court agreed that the neuroimage was confirmatory of the claimant’s mental disability claim and clinically correlated with his abnormal mental status examination, functional incapacity, and neuropsychological testing.57 54 42 u.s.c. § 423(d)(1)(a) (2015) (defining “disability” as the “inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment”) (emphasis added). 55 see, e.g., william b. smith et al., proving the invisible injury: making an impact with video settlement documentaries in traumatic brain injury cases, forum, mar.-apr. 2010, at 27. 56 see joseph r. simpson, neuroimaging in forensic psychiatry: from the clinic to the courtroom 206, fig. 12.4 (joseph r. simpson ed., 2012). 57 id. 706 indiana health law review vol. 12:2 iii. mental health parity law like the private disability plans discussed in part ii, private health insurance policies and plans also (at least historically) have distinguished between physical and mental illnesses and have provided inferior insurance benefits for mental illnesses. that is, private health insurance policies and plans have either completely excluded treatments and services for mental disorders from insurance coverage or have provided less comprehensive health insurance coverage for mental disorders.58 i teach at the william s. boyd school of law at the university of nevada, las vegas (boyd), located a few blocks from the famous las vegas strip, and at boyd we think a lot about the legal rights of individuals with gambling disorders as well as the legal responsibilities of casinos vis-à-vis such individuals. historically, many private health plans have provided no insurance coverage of treatments and services for gambling disorder59 as well as many similar mental disorders.60 in the past two decades, health insurance law has eliminated most, but still not all, of these mental health benefit disparities. after reviewing recent improvements in mental health parity law, i will use the case of gambling disorder to illustrate how advances in neuroscience are being used to confront remaining mental health benefit disparities. 58 see stacey a. tovino, a proposal for comprehensive and specific essential mental health and substance use disorder benefits, 38 am. j.l. & med. 471, 475 (2012); stacey a. tovino, all illnesses are (not) created equal: reforming federal mental health insurance law, 49 harv. j. on legis. 1, 3 (2012). 59 see, e.g., tovino, lost in the shuffle, supra note 11, at nn. 127131 (providing examples of health insurance policies and plans that have provided no or inferior health insurance benefits for individuals with gambling disorder). 60 elsewhere, i detailed how litigants have tried to confront these artificial distinctions in health insurance policies and plans in order to obtain comprehensive health insurance benefits. see, e.g., stacey a. tovino, all illnesses are (not) created equal, 49 harv. j. on legis. 1, 31-5 (2010). 2015 will neuroscience redefine mental injury? 707 the federal government took its first step towards establishing mental health parity on september 26, 1996, when president bill clinton signed the federal mental health parity act (mhpa) into law.61 as originally enacted, mhpa prohibited large group health plans that offered medical and surgical benefits as well as mental health benefits from imposing more stringent lifetime and annual spending limits on their offered mental health benefits.62 for example, mhpa would have prohibited a large group health plan from imposing a $20,000 annual cap or a $100,000 lifetime cap on mental health care if the plan had no annual or lifetime caps for medical and surgical care or if the plan had higher caps, such as a $50,000 annual cap or a $500,000 lifetime cap, for medical and surgical care.63 the problem with mhpa was that its application and scope were very limited. as originally enacted, mhpa only regulated insured and self-insured group health plans of large employers, then defined as those employers that employed an average of fifty-one or more employees.64 mhpa thus did not apply to the group health plans of small employers.65 mhpa also did not apply to individual health plans, the medicare program, medicaid non-managed care plans, or any self-funded, non-federal governmental plan whose sponsor opted out of mhpa.66 finally, mhpa 61 see mental health parity act, pub. l. no. 104-204, 110 stat. 2944 (1996), title vii, § 701 et seq. [hereinafter mhpa] (codified as amended at 29 u.s.c. § 1185a (2006 & supp. iv 2010); 42 u.s.c. § 300gg-26 (2006 & supp. iv 2010)). 62 see id. § 712(a)(1), (2). 63 see id. 64 see id. (applying in each case to “a group health plan (or health insurance coverage offered in connection with such a plan . . .”)). 65 see id. § 712(c)(1)(a), (b) (exempting from mhpa application group health plans of small employers; defining small employers as those who employed an average of at least 2 but not more than fifty employees on business days during the preceding calendar year and who employs at least two employees on the first day of the plan year). 66 see, e.g., 42 u.s.c. § 300gg-21(a)(2)(a) (permitting sponsors of self-insured non-federal governmental health plans to opt out of particular federal requirements); 45 c.f.r. § 146.180(a)(1)(v) (permitting sponsors of self-insured non-federal governmental health plans to opt out of federal mental health parity requirements). 708 indiana health law review vol. 12:2 contained an “increased cost” exemption for covered group health plans or health insurance coverage offered in connection with such plans if the application of mhpa resulted in an increase in the cost under the plan of at least one percent.67 by november 1998, over two years following mhpa’s enactment, only four plans across the united states had obtained exemptions due to cost increases of one percent or more.68 in terms of its substantive provisions, mhpa was neither a mandated offer nor a mandated benefit law; that is, nothing in mhpa required a large group health plan to actually offer or provide any mental health benefits.69 thus, health plans were free after the enactment of mhpa to simply not provide any benefits for gambling disorder or any other mental health condition.70 as originally enacted, mhpa also was not a comprehensive parity law because it expressly excluded from protection individuals with substance use and addictive disorders, such as alcohol use disorder and other drug use disorders.71 (mhpa did not specifically mention gambling disorder one way or another.) in addition, mhpa did not require parity between medical and surgical benefits and mental health benefits in terms of deductibles, copayments, coinsurance, inpatient day limitations, or outpatient visit limitations.72 67 mhpa, supra note 61, at § 712(c)(2). 68 see colleen l. barry, the political evolution of mental health parity, 14 harv. rev. psychiatry 185, 187 (2006) [hereinafter barry, political evolution]. 69 see mhpa, supra note 61, § 712(b)(1) (stating, “nothing in this section shall be construed as requiring a group health plan (or health insurance coverage offered in connection with such a plan) to provide any mental health benefits . . .”). 70 see id. 71 see id. § 712(e)(4) (stating, “the term ‘mental health benefits’ means benefits with respect to mental health services, as defined under the terms of the plan or coverage (as the case may be), but does not include benefits with respect to treatment of substance abuse or chemical dependency.”) 72 see id. § 712(b)(2) (stating, “nothing in this section shall be construed . . . as affecting the terms and conditions (including cost sharing, limits on numbers of visits or days of coverage, and requirements relating to medical necessity) relating to the amount, http://dx.doi.org/10.1080/10673220600883168 2015 will neuroscience redefine mental injury? 709 because of these limitations, president george w. bush expanded mhpa twelve years later by signing into law the paul wellstone and pete domenici mental health parity and addiction equity act of 2008 (mhpaea).73 mhpaea built on mhpa by expressly protecting individuals with substance-related and addictive disorders and by imposing comprehensive parity requirements on large group health plans.74 in particular, mhpaea provided that any financial requirements (including deductibles, copayments, coinsurance, and other out-of-pocket expenses)75 and treatment limitations (including inpatient day and outpatient visit limitations)76 that large group health plans imposed on mental health and substance use disorder benefits must not be any more restrictive than the predominant financial requirements and treatment limitations imposed by the plan on substantially all medical and surgical benefits.77 mhpaea thus would have prohibited large group health plans from imposing higher deductibles, copayments, or coinsurances, or lower inpatient day and outpatient visit maximums, on individuals seeking care for gambling disorder or any other mental health or duration, or scope of mental health benefits under the plan or coverage . . . ”). 73 see mental health parity and addiction equity act of 2008, pub. l. no. 110-343, 122 stat. 3881, title v, subtitle b, §§ 511-512 [hereinafter mhpaea] (codified as amended at 29 u.s.c. § 1185a and 42 u.s.c. § 300gg-26). 74 see id. § 512(a)(4) (adding a new definition of ‘substance use disorder benefits’); id. § 512(a)(1) (regulating the financial requirements and treatment limitations that are applied to both mental health and substance use disorder benefits). 75 see id. § 512(a)(1) (including within the definition of “financial requirements” deductibles, copayments, coinsurance, and out-of-pocket expenses). 76 see id. (including within the definition of “treatment limitations” limits on the frequency of treatment, number of visits, days of coverage, and other similar limits on the scope or duration of treatment). 77 see id. (requiring both financial requirements and treatment limitations applicable to mental health and substance use disorder benefits to be no more restrictive than the predominant financial requirements and treatment limitations applied to substantially all physical health benefits covered by the plan). 710 indiana health law review vol. 12:2 substance use disorder listed in the current edition of the dsm or the international classification of diseases (icd).78 like mhpa, mhpaea’s application and scope were very limited. as originally enacted, mhpaea only regulated insured and self-insured group health plans of large employers, defined as those employers that employ an average of fifty-one or more employees.79 mhpaea, like mhpa, did not apply to small group health plans, individual health plans, the medicare program, medicaid non-managed care plans, or any self-funded, non-federal governmental plans whose sponsors had opted out of mhpaea.80 in terms of its substantive provisions, 78 see, e.g., 78 fed. reg. 68240, 68286 (nov. 13, 2013) (adopting 45 c.f.r. § 146.136, a federal regulation implementing mhpaea that requires a plan’s definition of “mental health benefits” and “substance use disorder benefits” to be “consistent with generally recognized independent standards of current medical practice (for example, the most current version of the diagnostic and statistical manual of mental disorders (dsm), the most current version of the icd, or state guidelines”). 79 mhpaea, supra note 73, § 512(a)(1) (applying only to group health plans or health insurance coverage offered in connection with such plans). 80 see ctrs. for consumer info. & ins. oversight, the mental health parity and addiction equity act, u.s. dep’t health & human servs., (providing, “mhpaea does not apply directly to small group health plans.”); id. (“[medicare, medicaid] are not issuers of health insurance. they are public health plans through which individuals obtain health coverage. . . . medicaid benchmark benefit plans [however] . . . require compliance with certain requirements of mhpaea.”); id. (“non-federal governmental employers that provide self-funded group health plan coverage to their employees (coverage that is not provided through an insurer) may elect to exempt their plan (opt-out) from the requirements of mhpaea . . . .”); colleen l. barry et al., a political history of federal mental health and addiction insurance parity, 88 milbank q. 404, 407 (2010) (explaining that the mhpaea applies to medicare advantage coverage offered through a group health plan, medicaid managed care, the state children’s health insurance program, and state and local government plans, but not medicaid nonmanaged care plans); letter from cindy mann, dir. of the ctr. for medicaid and chip servs. (cmcs), ctrs. for medicare & medicaid servs., dep’t of health & human servs., to state health officials 2 (nov. 4, 2009) (“the mhpaea requirements apply to medicaid only insofar as a state’s medicaid agency contracts with one or more managed care organizations (mcos) or prepaid inpatient health plans http://dx.doi.org/10.1111/j.1468-0009.2010.00605.x 2015 will neuroscience redefine mental injury? 711 mhpaea also was neither a mandated offer nor a mandated benefit law; that is, nothing in mhpaea required a covered group health plan to actually offer or provide any gambling disorder benefits or other mental health benefits.81 like mhpa, mhpaea also contained an “increased cost” exemption for covered group health plans and health insurance coverage offered in connection with such plans, but under mhpaea the amount of the required cost increase increased, at least for the first year.82 that is, a covered plan that could demonstrate a cost increase of at least two percent in the first plan year and one percent in each subsequent plan year of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits would be eligible for an exemption from mhpaea for such year.83 mhpaea required determinations of exemption-qualifying cost increases to be made and certified in writing by a (pihps), to provide medical/surgical benefits as well as mental health or substance use disorder benefits . . . . mhpaea parity requirements do not apply to the medicaid state plan if a state does not use mcos or pihps to provide these benefits.”). 81 see mhpaea, supra note 73, § 512(a)(1) (regulating only those group health plans that offer both physical health and mental health benefits); substance abuse and mental health services administration, implementation of the mental health parity and addiction equity act, (mphaea), u.s. dep’t health & human serv., http://www.samhsa.gov/health-financing/implementation-mentalhealth-parity-addiction-equity-act (noting that “self-insured non-federal government employee plans can opt out of the federal parity law”; further stating that, “the requirements of parity do not apply to … [s]mall employer plans created before march 23, 2010 … ; churchsponsored plans and self-insured plans sponsored by state and local governments; retiree-only plans; tricare; medicare; traditional medicaid (fee-for-service, non-managed care)”; centers for medicare & medicaid services, the ctr. for consumer info. & ins. oversight, the mental health parity and addiction equity act, u.s. dep’t health & human servs., http://cms.hhs.gov/cciio/programs-andinitiatives/other-insurance-protections/mhpaea_factsheet.html (noting the same limitations). 82 see mhpaea, supra note 73, § 512(a)(3) (establishing new cost exemption provisions). 83 id. 712 indiana health law review vol. 12:2 qualified and licensed actuary who in good standing belongs to the american academy of actuaries.84 before president obama signed the health care reform bill into law, then, mental health insurance benefits were regulated by mhpa as expanded by mhpaea as well as by more stringent state law.85 that is, unless a more stringent state law required a health plan to provide gambling disorder benefits or other mental health benefits (which state law usually did not), a health plan was not required to provide such benefits. in late march 2010, president obama responded to this limitation by signing the patient protection and affordable care act (ppaca) and the health care and education reconciliation act (hcera) into law (as consolidated, the affordable care act (aca)).86 best known for its controversial individual health insurance mandate,87 aca has two sets of provisions that relate to mental health parity and mandatory mental health and substance use disorder benefits. upheld by the u.s. supreme court on june 28, 2012,88 these two sets of provisions eliminate some of the limitations of mhpa and mhpaea. the first set of aca provisions extends mhpa’s and mhpaea’s mental health parity provisions to the individual and small group health plans offered on and off 84 id. 85 see stacey a. tovino, reforming state mental health parity law, 11 hous. j. health l. & pol’y 455, at parts i.a.–i.d. (2011) (describing the patchwork of state mental health parity law and providing examples of state laws that are more and less stringent than federal law). 86 see patient protection and affordable care act (aca), pub. l. no. 111-148, 124 stat. 119 (2010), amended by health care and education reconciliation act, pub. l. no. 111-152, 124 stat. 1029 (2010) [hereinafter, aca]. 87 aca § 1501(a) (adding to the internal revenue code: ‘‘an applicable individual shall for each month beginning after 2013 ensure that the individual, and any dependent of the individual who is an applicable individual, is covered under minimum essential coverage for such month.”). 88 nat’l. fed’n. of indep. bus. v. sebelius, 132 s. ct. 2566 (2012). 2015 will neuroscience redefine mental injury? 713 the health insurance exchanges.89 now, many individual and small group health plans that previously discriminated against individuals with gambling disorder and other mental health conditions through higher deductibles, copayments, and coinsurance rates, as well as lower inpatient day and outpatient visit limitations, must comply with mhpa and mhpaea.90 the second set of relevant aca provisions requires certain health plans to actually provide mental health and substance use disorder benefits. that is, aca now requires individual and small group health plans,91 exchange-offered qualified health plans,92 state basic health plans,93 and medicaid benchmark and medicaid benchmark plans94 to offer “mental health and substance use disorder services, including behavioral health treatments” in addition to nine other categories of essential health benefits (ehbs).95 unfortunately, not every individual with health insurance will benefit from these ten required ehb categories because 89 aca, supra note 86, § 1311(j) (entitled, “applicability of mental health parity”) (stating, “[mhpaea] shall apply to qualified health plans in the same manner and to the same extent as such section applies to health insurance issuers and group health plans.”); 42 u.s.c. § 300gg-26 (2015) (entitled “parity in mental health and substance use disorder benefits’); aca, supra note 86, § 1563(c)(4) (identifying the conforming and technical changes that will be made to former 42 u.s.c. 300gg-5 (current 42 u.s.c. § 300gg-26)); historical and statutory notes for former 42 u.s.c. § 300gg-5 (noting that former 42 u.s.c. § 300gg-5 was transferred to 42 u.s.c. § 300gg-26). see also ctr. for consumer info. & ins. oversight, essential health benefits bulletin, u.s. dep’t health & human servs., 1, 12 (dec. 16, 2011) [hereinafter ehb bulletin] (“the affordable care act also specifically extends mhpaea to the individual market.”). 90 see supra note 89. 91 aca, supra note 86, § 1201 (adding new public health service act § 2707(a), codified at 42 u.s.c. § 300gg-6(a)). 92 id. § 1301(a)(1)(b) (adding new 42 u.s.c. § 18021(a)(1)(b)). 93 id. § 1331(e). individuals eligible for state basic health plan coverage include individuals who are not eligible for medicaid and whose household income falls between 133 and 200 percent of the federal poverty line for the family involved as well as low-income legal resident immigrants. aca, supra note 86, § 1331(e). 94 id. § 2001(c)(3) (adding new 42 u.s.c. § 1396u-7(b)(5)). 95 id. § 1302(b)(1)(a)-(j). 714 indiana health law review vol. 12:2 grandfathered health plans, large group health plans, and self-insured health plans are exempt from the requirement to provide the ten ehb categories.96 for those health plans that must provide benefits within the ten ehb categories, the statutory ehb requirements are unclear as to whether particular benefits, such as gambling disorder benefits, are required. as a result, the federal department of health and human services (hhs) issued final regulations implementing aca’s ehb requirements (final regulations) on february 25, 2013.97 these final regulations permit states to select a benchmark plan98 that provides coverage for the ten ehb categories, including mental health and substance use 96 interim final rules for group health plans and health insurance coverage relating to status as a grandfathered health plan under the patient protection and affordable care act, 75 fed. reg. 34538, 34562 (june 17, 2010) [hereinafter, interim final grandfather rules] (adding new 29 c.f.r. § 2590.715–1251(a), which defines ‘grandfathered health plan coverage’ as “coverage provided by a group health plan, or a health insurance issuer, in which an individual was enrolled on march 23, 2010.”); id. at 34559 (explaining that section 2707 of the public health service act does not apply to grandfathered health plans); id. at 34563 (adding new 29 c.f.r. § 2590.715-1251(c)(1) (stating, “[t]he provisions of phs act sections . . . 2707 . . . do not apply to grandfathered health plans.”)); dep’t labor, employee benefits security admin., application of the new health reform provisions of part a of title xxvii of the phs act to grandfathered plans 1 (june 17, 2010) (explaining that aca’s essential benefit package requirement is not applicable to grandfathered plans); see inst. of med., essential health benefits: balancing coverage and cost (2011), at 1-8, 1-9, 1-10 and box 1-2 (listing the health plan settings to which aca’s ehb requirement do not apply); sara rosenbaum et al., the essential health benefits provisions of the affordable care act: implications for people with disabilities, 3 commonwealth fund 1, 3 (mar. 24, 2011) (“the act exempts large-group health plans, as well as self-insured erisa plans and erisa-governed multiemployer welfare arrangements not subject to state insurance law, from the essential benefit requirements.”). 97 patient protection and affordable care act, pub. l. no. 111-148, 124 stat. 119 (2010); standards related to essential health benefits, actuarial value, and accreditation; final rule, 78 fed. reg. 12834 (feb. 25, 2013) [hereinafter final ehb regulations]. 98 final ehb regulations, supra note 97, at 12866 (adopting 45 c.f.r. § 156.100). 2015 will neuroscience redefine mental injury? 715 disorder services,99 that will serve as a reference plan for health plans in the state. according to the final regulations, health plans in the state that are required to provide the ten ehb categories shall provide health benefits that are substantially equal to those provided by the state’s benchmark plan, including the benchmark plan’s covered benefits and excluded benefits.100 thus, the question of whether a particular health insurance policy or plan must provide benefits for a particular mental disorder after the aca requires an analysis of whether the plan is required to provide the ten ehb categories as well as the content of each state’s selected benchmark plan. and this is where neuroscience is coming into play. in an article recently published in the tulane law review, i analyzed whether state benchmark plans, including nevada’s benchmark plan, covered treatments and services for gambling disorder.101 the state of nevada’s benchmark plan is the health plan of nevada point of service group 1 c xv 500 hcr plan.102 if, as written on march 31, 2012, the nevada benchmark plan included gambling disorder benefits, then individual, small group, and other health plans in the state of nevada that are required to provide the ten ehb categories must provide gambling disorder benefits in years 2014 and 2015.103 on the other hand, if the nevada benchmark plan did not include gambling disorder benefits on march 31, 2012, then gambling disorder 99 id. at 12866 (adopting 45 c.f.r. § 156.110(a)(5)). 100 id. at 12867 (adopting 45 c.f.r. § 156.115(a)). 101 tovino, lost in the shuffle, supra note 11. 102 see nevada ehb benchmark plan, ctr. for medicare & medicaid serv., available at http://www.cms.gov/cciio/ resources/data-resources/downloads/nevada-ehb-benchmark-plan.pdf; letter from scott j. kipper, comm’r of ins., div. of ins., state of nev., to sec’y kathleen sebelius, u.s. dep’t of health & human services (dec. 14, 2012), available at http://doi.nv.gov/uploadedfiles/doinvgov/_publicdocuments/healthcare-reform/12.14.12_kipper_letter_re_ehb.pdf (identifying nevada’s benchmark plan selection). 103 see e-mail from glenn shippey, nev. div. of ins., to stacey tovino, lincy professor of law, william s. boyd sch. of law, univ. of nev., las vegas (oct. 2, 2013, 4:12 pm) (on file with author) [hereinafter shippey email] (explaining the application of the ehb requirements in the state of nevada). 716 indiana health law review vol. 12:2 benefits are not essential health benefits in the state of nevada and individuals with gambling disorder will not have gambling disorder benefits in years 2014 and 2015 unless their health plans voluntarily include such benefits104 or unless the states in which they live independently fund gambling disorder treatments and services.105 on march 31, 2012, the nevada benchmark plan included coverage for outpatient and inpatient treatment of certain mental health conditions, including substancerelated conditions (such as alcohol use disorder and the drug use disorders).106 on march 31, 2012, however, the nevada benchmark plan excluded coverage for a class of mental health conditions known as the “impulse control disorders.”107 because the then-current (2012) edition of the dsm—the dsm-iv-tr—classified “pathological gambling” as an impulse control disorder, the result was that the nevada benchmark plan excluded coverage for treatments for gambling disorders for years 2014 through 2016. that is, through the end of 2016, nevada residents will not benefit from any mandatory gambling disorder benefits and will only have benefits to the extent their health plans voluntarily provide gambling disorder benefits or their states independently fund gambling disorder treatments. 104 see essential health benefits (updated), health affairs, health policy briefs (may 2, 2013), http://www.healthaffairs.org/ healthpolicybriefs/brief.php?brief_id=91 (noting that hhs has indicated that the benchmark plan approach may be changed in 2016 and in future years based on evaluation and feedback). 105 see, e.g., bo j. bernhard et al., evaluation of state-funded problem gambling treatment programs in nevada, available at https://www.yumpu.com/en/document/view/35015311/evaluation-ofstate-funded-problem-gambling-treatment-programs(discussing problem gambling treatments that are partially or fully supported by the state of nevada). 106 see ctr. for medicare & medicaid serv., nevada ehb benchmark plan 3, rows 26 and 27, available at http://www.cms.gov/cciio/resources/dataresources/downloads/nevada-ehb-benchmark-plan.pdf. 107 see shippey e-mail, supra note 103 (noting the nevada benchmark plan’s exclusion of “impulse control disorders”). 2015 will neuroscience redefine mental injury? 717 however, due to neuroimaging, the story may be very different for years 2017 and beyond. that is, advances in the neuroscientific understanding of certain mental disorders have resulted in their reclassification in the dsm. let us use gambling disorder as an example. first recognized by the apa in the dsm-iii in 1980,108 a condition then-named “pathological gambling” was classified within the “disorders of impulse control not elsewhere classified.”109 characterized with reference to an individual’s “chronic and progressive failure to resist impulses to gamble and gambling behavior that compromises, disrupts, or damages personal, family, or vocational pursuits,” pathological gambling was believed by the apa to have an adolescent age of onset and to be more common among males than females and more common in the fathers of males and in the mothers of females.110 predisposing factors were thought to include loss of parent by death, separation, divorce, or desertion before the individual turned fifteen years of age; inappropriate parental discipline; exposure to gambling activities as an adolescent; a high family value on material and financial symbols; and lack of family emphasis on saving, planning, and budgeting.111 pathological gambling remained in the “disorders of impulse control not elsewhere classified” 108 the word “gambling” does not appear anywhere in the first or second editions of the dsm. see am. psychiatric ass’n, diagnostic and statistical manual of mental disorders (1952) [hereinafter dsm-i]; am. psychiatric ass’n, diagnostic and statistical manual of mental disorders with special supplement on plans for revision (1965) [hereinafter dsm-i-r]; and am. psychiatric ass’n, diagnostic and statistical manual of mental disorders (2d ed. 1968) [hereinafter dsm-ii]. see also randy stinchfield, reliability, validity, and classification accuracy of a measure of dsm-iv diagnostic criteria for pathological gambling, 160 am. j. psychiatry 180, 180 (2003) (stating, “pathological gambling was formally recognized as a mental disorder by apa in dsm-iii.”). 109 am. psychiatric ass’n, diagnostic and statistical manual of mental disorders 291-93 (3d ed. 1980) [hereinafter dsm-iii]. 110 id. at 292. 111 id. http://dx.doi.org/10.1176/appi.ajp.160.1.180 718 indiana health law review vol. 12:2 sections of the dsm-iii-r (1987), the dsm-iv (1994), and the dsm-iv-tr (2000).112 the dsm-5, published in may 2013,113 took pathological gambling in a new direction. first, the dsm-5 re-named the condition “gambling disorder,”114 reflecting concerns that the adjective “pathological” is pejorative and reinforces the social stigma associated with problem gambling.115 second, the dsm-5 re-classified gambling disorder and placed it as the sole disorder within the “non-substancerelated disorders” section within the larger “substancerelated and addictive disorders” chapter.116 now, gambling disorder follows alcohol use disorder, cannabis use disorder, opioid use disorder, stimulant use disorder, and tobacco use disorder, among other substance-related and addictive disorders.117 the change in gambling disorder’s classification reflected neuroimaging evidence that “gambling behaviors activate [neural] reward systems similar to those activated by drugs of abuse and produce[s] behavioral symptoms that appear comparable to those produced by the substance use disorders.”118 charles o’brien, m.d., who chaired the 112 tovino, lost in the shuffle, supra note 11, at text accompanying notes 20-34. 113 am. psychiatric ass’n, diagnostic and statistical manual of mental disorders 585 (5th ed. 2013) [hereinafter dsm-5]; see nancy m. petry et al., an overview of and rationale for changes proposed for pathological gambling in the dsm-5, 30 j. gambling stud. 493, 495 (2013). 114 see dsm-5, supra note 113. 115 see christine reilly & nathan smith, the evolving definition of pathological gambling in the dsm-5, nat’l ctr. for responsible gaming white paper 4 (may 2013); petry et al., supra note 113, at 406 (“over the past three decades, the term ‘pathological’ has become outdated and pejorative. thus, the name of the disorder will be altered in dsm-5 to ‘gambling disorder.’”). 116 dsm-5, supra note 113, at 481. 117 id. at 483-585; constance holder, behavioral addictions debut in proposed dsm-v, 327 science 935 (feb. 19, 2010) (noting that gambling disorder would be the only disorder in the behavioral, or nonsubstance, portion of the substance-related and addictive disorders category). 118 dsm-5, supra note 113, at 481; see also kenneth blum et al., reward deficiency syndrome: addictive, impulsive and compulsive http://dx.doi.org/10.1007/s10899-013-9370-0 http://dx.doi.org/10.1126/science.327.5968.935 2015 will neuroscience redefine mental injury? 719 substance-related disorders work group for the dsm-5, explained: the idea of a non-substance-related addiction may be new to some people, but those of us who are studying the mechanisms of addiction find strong evidence from animal and human research that addiction is a disorder of the brain reward system, and it doesn’t matter whether the system is repeatedly activated by gambling or alcohol or another substance. . . . in functional brain imaging—whether with gamblers or drug addicts—when they are showed video or photograph cues associated with their addiction, the same brain areas are activated.119 in summary, the current nevada benchmark plan includes coverage for outpatient and inpatient treatment of substance-related and addictive conditions. if this benchmark plan is selected again for years 2017 and beyond,120 the result would be that insurance coverage of substance-related and addictive conditions, now including gambling disorder, would be required by federal law. stated slightly differently, advances in the neuroscientific understanding of gambling disorder will have positively impacted the disorder’s insurance coverage. disorders—including alcoholism, attention-deficit disorder, drug abuse and food bingeing—may have a common genetic basis, 84 american scientist 132, 140 (1996) (noting the affinities between pathological gambling and alcohol and drug abuse). 119 mark moran, gambling disorder to be included in addictions chapter, psychiatric news (oct. 22, 2014), available at http://psychnews.psychiatryonline.org/doi/full/10.1176%2fappi.pn.2013. 4b14, archived at http://perma.cc/95qz-p8z7. 120 see 80 fed. reg. 10750, 10812-13 (feb. 27, 2015) (requiring each state to select a new base-benchmark plan for the 2017 plan year based on a 2014 plan meeting the requirements of 45 c.f.r. § 156.110; explaining, “[w]e are finalizing the re-codification of part of § 156.120 as proposed, as well as our proposal to allow issuers to design a plan that is substantially equal to the newly selected 2014 benchmark plan for the 2017 plan year.”). 720 indiana health law review vol. 12:2 iv. disability discrimination law the final area of the law on which i wanted to focus is disability discrimination law. like public disability benefit law, disability discrimination law does not generally discriminate against individuals with mental disabilities. however, disability discrimination law does except certain conditions, including a handful of mental health conditions, from the definition of disability. although litigants have not yet used advances in neuroscience to confront these exceptions, i predict that they will shortly. as background, a range of anti-discrimination protections and accommodations are available to qualified individuals who have physical and mental disabilities under a variety of federal and state laws. signed into law by president richard nixon on september 26, 1973, section 504 of the rehabilitation act prohibits employers and organizations that receive federal financial assistance from discriminating on the basis of disability against qualified individuals with disabilities.121 the original americans with disabilities act (ada), signed into law by president george h.w. bush on july 26, 1990, prohibits certain employers, state and local government agencies, and places of public accommodation from discriminating on the basis of disability against qualified individuals with disabilities.122 the ada amendments act of 2008 (adaaa), signed into law by president george w. bush on september 25, 2008, clarifies that the ada’s definition of disability should be broadly construed in favor of individuals with physical and mental impairments who seek protection and generally 121 rehabilitation act of 1973, § 504, pub. l. no. 93-112, 87 stat. 355 (sept. 26, 1973) (codified at 29 u.s.c. §§ 701–718) (providing, “no otherwise qualified handicapped individual in the united states . . . solely by reason of his handicap, be excluded from the participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal financial assistance.”). 122 americans with disabilities act of 1990, pub. l. no. 101-336, 104 stat. 327 (july 26, 1990) (codified at 42 u.s.c. §§ 12101–12150 [hereinafter ada]). 2015 will neuroscience redefine mental injury? 721 shall not require extensive analysis.123 state laws such as the california fair housing and employment act also provide individuals with protection from harassment and discrimination in the contexts of housing and employment because of physical or mental disability.124 one theme underlying these federal and state statutes is that it is wrong to discriminate against individuals because of their physical and mental disabilities and that it is right to accommodate them to help them participate more fully in society.125 to determine whether an individual is entitled to protection under one of these statutes, each statute’s definition of “disability” must be examined.126 for example, the original ada defined a disability as, “with respect to an individual -(a) a physical or mental impairment that substantially limits one or more of the major life activities of such individual; (b) a record of such an impairment; or (c) being regarded as having such an impairment.”127 the regulations implementing the original ada defined “physical or mental impairment” to include, in relevant 123 the ada amendments act of 2008, pub. l. no. 110-325, 122 stat. 3553 (sept. 25, 2008) (codified at 42 § u.s.c. 12101) [hereinafter adaaa]. 124 cal. gov’t code § 12940 (west 2015); cal. gov’t code § 12955 (west 2015). 125 see, e.g., timothy p. ward, needing a fix: congress should amend the americans with disabilities act of 1990 to remove a record of addiction as a protected disability, 36 rutgers l.j. 683, 719 (2005) (stating that “[i]mplicit in congress’s legitimate goal of protecting the disabled from discrimination is the idea that discrimination against disabled persons is unfair because it is wrong to treat a person differently based on circumstances or conditions over which he has no control.”). 126 the definitions of “disability” that are used by the ssa and by private disability income insurance benefit insurers, discussed in supra part i, are different than the definitions used by federal and state antidiscrimination laws and are not applicable here. see, e.g., labit v. akzonobel salt, inc., no. 99-30047, 2000 u.s. app. lexis 41195, at *1-4 (5th cir. feb. 7, 2000) (distinguishing social security disability determinations from ada disability determinations and noting, for example, that social security disability determinations do not take into account workplace accommodations). 127 ada § 3(2)(a)-(c) (emphasis added). 722 indiana health law review vol. 12:2 part, “any physiological disorder, or condition, . . . affecting . . . [the] neurological [system]” or “[a]ny mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities.”128 these regulations also defined “major life activities” to include “functions such as caring for oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, and working.”129 note that both the ada and its implementing regulations used the phrase “physical or mental impairment.” like public disability benefit law, then, individuals with mental impairments appear to be expressly included in the ada’s general protections. title i of the ada, relating to employment, prohibited covered entities from “discriminat[ing] against a qualified individual with a disability130 because of the disability of such individual in regard to job application procedures, the hiring, advancement, or discharge of employees, employee compensation, job training, and other terms, conditions, and privileges of employment.”131 several different portions of the original ada’s implementing regulations promulgated by the equal employment opportunity commission (eeoc),132 a lengthy set of interpretive guidelines,133 and 128 29 c.f.r. § 1630.2(h)(1)-(2) (emphasis added) (pre-adaaa regulations establishing the definition of physical or mental impairment); see also equal employment opportunity for individuals with disabilities, 56 fed. reg. 35,726 (july 26, 1991) (codified at 29 c.f.r. § 1630.2(h)(1)-(2)). 129 id. § 1630.2(i)); see also equal employment opportunity for individuals with disabilities, supra note 128. 130 title i of the ada defined a qualified individual with a disability as “an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the employment position that such individual holds or desires.” ada § 101(8). 131 ada § 102(a). 132 see, e.g., 29 c.f.r. § 1630.2(h)(2) (2007) (pre-adaaa regulations clarifying that a protected mental impairment includes “any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities.”). 133 see, e.g., appendix to 29 c.f.r. § 1630 -interpretive guidance on title i of the americans with disabilities act (pre-adaaa 2015 will neuroscience redefine mental injury? 723 hundreds of judicial opinions134 were dedicated to distinguishing the conditions that would and would not result in an individual’s protection under the statute. for example, title i of the original ada clarified that the term “qualified individual with a disability” did not include “any employee or applicant who is currently engaging in the illegal use of drugs, when the covered entity acts on the basis of such use.”135 however, title i of the original ada also clarified that an individual who meets the following criteria must not be excluded from protection: (1) has successfully completed a supervised drug rehabilitation program and is no longer engaging in the illegal use of drugs, or has otherwise been rehabilitated successfully and is no longer engaging in such use; (2) is participating in a supervised rehabilitation program and is no longer engaging in such use; or (3) is erroneously regarded as engaging in such use, but is not engaging in such use . . .”136 importantly, title i of the ada also specifically excluded “compulsive gambling” (as well as kleptomania and pyromania) from the definition of disability.137 the exclusion is complete; that is, individuals who have interpretive guidance providing, “it is important to distinguish between conditions that are impairments and physical, psychological, environmental, cultural, and economic characteristics that are not impairments. . . . the definition, likewise, does not include characteristic predisposition to illness or disease. . . . [similarly,] [t]he definition does not include common personality traits such as poor judgment or a quick temper where these are not symptoms of a mental or psychological disorder. environmental, cultural, or economic disadvantages such as poverty, lack of education or a prison record are not impairments.”). 134 search on westlawnext database returned 1597 cases in the notes of decision section of 42 u.s.c. § 12102 (2015). search conducted on june 2, 2015 (listing cases that distinguish protected disabilities from unprotected conditions). 135 ada § 104(a). 136 id. § 104(b). 137 id. § 511(b)(2). 724 indiana health law review vol. 12:2 successfully completed a gambling rehabilitation program and are no longer engaged in gambling are not excepted from the exclusion (i.e., are not protected) in the same way that individuals who have successfully completed a drug rehabilitation program and are no longer engaged in the use of drugs are excepted. case law interpreting the original ada confirms that individuals with gambling disorder are not protected.138 the ada’s complete exclusion of compulsive gambling from the definition of disability may be due to its original classification as an impulse control disorder. as discussed in part iii of this article, the apa initially classified pathological gambling as an impulse control disorder (alongside kleptomania,139 pyromania,140 and intermittent explosive disorder141) in the dsm-iii (1980). as late as 2000, in the dsm-iv-tr (2000)—ten years after the enactment of the original ada – the apa continued to classify pathological gambling as an impulse control disorder (still alongside kleptomania, pyromania, intermittent explosive disorder, and trichotillomania142).143 138 see, e.g., labit, 2000 u.s. app. lexis 41195, at *2 (stating, “congress specifically excluded compulsive gambling as a disability under the act.”); see also trammell v. raytheon missile systems, 721 f. supp.2d 876, 878-82 (d. ariz. 2010) (stating, “congress expressly excluded compulsive gambling, along with various sexual disorders, kleptomania, pyromania, and psychoactive substance use disorders resulting from current drug use, from the ada’s definition of disability”; and rejecting the plaintiff’s theory that compulsive gambling is synonymous with depression “given the ada’s express exclusion of compulsive gambling as a disability”). 139 kleptomania, according to the dsm-iii, is the recurrent failure to resist impulses to steal objects not for immediate use or their monetary value. dsm-iii, supra note 109, at 293. 140 pyromania, according to the dsm-iii, is the recurrent failure to resist impulses to set fires and intense fascination with setting fires and seeing them burn. id. at 294. 141 intermittent explosive disorder, according to the dsm-iii, is characterized by several discrete episodes of loss of control of aggressive impulses that result in serious assault or destruction of property. id. at 295. 142 trichotillomania, according to the dsm-5, is the recurrent pulling out of one’s hair for pleasure, gratification, or relief of tension that results in noticeable hair loss. dsm-5, supra note 113, at 251. 2015 will neuroscience redefine mental injury? 725 not until may 2013, in the dsm-5, did the apa rename the condition gambling disorder and re-classify it as a “nonsubstance-related disorder” within the “substance-related and addictive disorders.”144 gambling disorder certainly may have suffered in its treatment by congress due to the disorder’s linkage to the other impulse control disorders. that is, stealing, fire setting, and hair-pulling may not have “sounded” in disability as much as other traditional neurological and psychiatric conditions. with respect to other health conditions that were not specifically excluded from protection, the question of whether individuals with such conditions would be protected by the ada required a case-by-case analysis of whether the condition constituted a physical or mental impairment and, if so, whether the impairment substantially limited a major life activity.145 the case law interpreting the original ada made clear that individuals with episodic symptoms, as well as individuals who took medications that controlled their symptoms, were not protected individuals with disabilities. in johnson v. north carolina department of health and human services, for example, the u.s. district court for the middle district of north carolina held that a county social worker with bipolar disorder and migraines was not substantially limited in the major life activity of working and, therefore, did not qualify as an individual with a disability under the 143 see american psychiatric association, diagnostic and statistical manual of mental disorders 674 (4th ed. – text revision 2000) [hereinafter dsm-iv-tr]. 144 dsm-5, supra note 113, at 585. 145 see, e.g., head v. glacier northwest inc., 413 f.3d 1053, 1057-61 (9th cir. 2005) (finding that genuine issues of material fact existed as to whether an employee diagnosed with depression or bipolar disorder was substantially limited in major life activity of interacting with others, due to such things as avoiding crowds and not leaving his house for weeks); mcgeshick v. principi, 357 f.3d 1146, 1150 (10th cir. 2004) (interpreting substantial limitation to mean that the impairment prevents or severely restricts the individual from doing activities that are of central importance to most people’s daily lives and that the impairment’s impact must be permanent or long term). 726 indiana health law review vol. 12:2 ada.146 similarly, in doebele v. sprint/united management company, the u.s. court of appeals for the tenth circuit held that an employee who was diagnosed with bipolar disorder, attention deficit disorder, and hypothyroidism was not significantly limited in her ability to communicate with others and, therefore, did not qualify as an individual with a disability under the ada.147 more broadly, in olson v. general electric astrospace, the u.s. court of appeals for the third circuit clarified that neither multiple personality disorder nor a sleep disorder constituted a disability without proof that the disorder also substantially limited a major life activity.148 by 2008, congress had grown weary of the limitations placed by courts on the classes of individuals eligible to receive protections under the ada.149 on september 25, 2008, president george w. bush signed the adaaa into law.150 the adaaa continued to use a three-prong definition of disability including, with respect to an individual: (1) a physical or mental impairment that substantially limits one or more major life activities of such individual; (2) a record of such an impairment; or (3) being regarded as having such an impairment.151 the adaaa further stated that the definition of disability in the adaaa “shall be construed in favor of broad coverage of individuals . . . to the maximum extent permitted by the terms of [the adaaa].”152 even after the enactment of the adaaa, however, congress continued to exclude certain conditions from the definition of disability. today, the ada as amended continues to exclude “compulsive gambling, kleptomania, or pyromania” from the definition of disability.153 many state 146 johnson v. north carolina dep’t of health & human servs., 454 f. supp.2d 467, 473 (m.d.n.c. 2006). 147 doebele v. sprint/united mgmt. co., 342 f.3d 1117, 1131-35 (10th cir. 2003). 148 101 f.3d 947, 952-53 (3d cir. 1996). 149 adaaa § 2 (a)-(b). 150 id. § 1. 151 id. § 3 (emphasis added). 152 id. 153 see 42 u.s.c. § 12211(b)(2) (2015). 2015 will neuroscience redefine mental injury? 727 laws also continue to exclude individuals with gambling disorder from protected status. for example, the california fair employment and housing act,154 which was designed to “protect and safeguard the right and opportunity of all persons to seek, obtain, and hold employment without discrimination or abridgment on account of” physical disability, mental disability, and other indicators,155 continues to exclude “compulsive gambling” from the definition of both “mental disability”156 and “physical disability.”157 unlike private disability benefit law and health insurance law, in which neuroscience is being used to confront mental disability benefit and mental health insurance disparities, i have not yet seen a lobbyist, litigant, or other stakeholder try to use the current neuroscientific understanding of gambling disorder, discussed at supra part iii, to remove the gambling disorder exclusion in disability discrimination law. however, i do think that a stakeholder could make a good argument that gambling disorder should be treated more like alcohol-use disorder and other substance-use disorders in federal and state disability discrimination law. v. conclusion in summary, private disability benefit law, health insurance law, and certain exceptions within federal and state disability discrimination law do discriminate against individuals with mental health conditions. in addition, it may be more difficult for individuals to prove their mental 154 cal. gov’t code § 12900-12996 (2015). 155 id. at § 12920. 156 id. § 12926(j) (stating, “‘mental disability’ does not include sexual behavior disorders, compulsive gambling, kleptomania, pyromania, or psychoactive substance use disorders resulting from the current unlawful use of controlled substances or other drugs.”). 157 id. § 12926(m)(6) (stating, “‘physical disability’ does not include sexual behavior disorders, compulsive gambling, kleptomania, pyromania, or psychoactive substance use disorders resulting from the current unlawful use of controlled substances or other drugs.”). 728 indiana health law review vol. 12:2 health conditions under public disability benefit law. further, neuroscience is being used to confront distinctions in private disability benefit law and health insurance law, and to help prove mental disabilities in public disability benefit law. stakeholders are not yet using neuroscience to confront exceptions from disability discrimination laws that discriminate against individuals with certain mental health conditions, including gambling disorder. however, i do anticipate that stakeholders may use neuroscience towards this end in the near future. stacey a. tovino, jd, phd0f( i. introduction ii. disability benefit law iii. mental health parity law iv. disability discrimination law v. conclusion international and operational responses to disease control: beyond ebola and epistemological confines dr. andra le roux-kemp * [e]pidemics resemble great warning signs on which the true statesman is able to read that the evolution of his nation has been disturbed to a point which even a careless policy is no longer allowed to overlook…don’t crowd disease point everywhere to deficiencies of society?...abnormal conditions always produce abnormal situations. war, plague and famine condition each other, and we don’t know any period in world history where they did not appear in more or less large measure either simultaneously or following each other. rudolf virchow, report on the typhus epidemic in upper silesia 307 (1848). i. introduction the twentieth major outbreak of ebola virus disease (“evd”) began undetected in december 2013 in guéckédou, guinea. a one-year old boy, emile oumnoouno, died on 28 december 2013, in meliandou, guinea, with symptoms of diarrhea and fever as the first casualty of the current and ongoing evd outbreak. by early 2014, high fatality rates had already sieged three west1 african nations: guinea, liberia and sierra leone. while cholera and lassa2 3 fever were first thought to be the likely cause of the fatalities, laboratory confirmation of evd was received on 23 march 2014; the date on which the4 ministry of health of guinea notified who of its rapidly evolving evd outbreak. from here on, things progressed rapidly and “members of the united5 nations security council expressed ‘their deep concern over the current outbreak of the ebola virus in some countries in west africa’” early in july 2014 as the6 * assistant professor, school of law at the city university of hong kong (hksar) and visiting research fellow, school of law, at the university of the witwatersrand (south africa). 1. kevin sack et al., how ebola roared back, n.y. times (dec. 29, 2014), http://www.nytimes.com/2014/12/30/health/how-ebola-roared-back.html?hp&action=click& pgtype=homepage&module=a-lede-package-region&region=top-news&wt.nav=top-news&_r=2 [https://perma.cc/zj34-ugxf]. 2. ebola virus disease in liberia, who regional off. afr. (mar. 30, 2014), http://www.who.int/csr/don/2014_03_30_ebola_lbr/en/ [https://perma.cc/h8w-56c6]. 3. ebola virus disease west africa—update, who regional off. afr. (may 28, 2014), http://www.who.int/csr/don/2014_05_28_ebola/en/ [https://perma.cc/n4su-npj5]. 4. anna petherick, ebola in west africa: learning the lessons, 385 lancet 591, 591 (2015). 5. ebola virus disease in guinea, who regional off. afr. (mar. 23, 2014), http://www.who.int/csr/don/2014_03_23_ebola/en/ [https://perma.cc/42aa-6p89]. 6. gian luca burci & jakob quirin, ebola, who, and the united nations: convergence http://doi.org/10.18060/3911.0049 248 indiana health law review [vol. 15:247 virus subsequently spread, through human-to-human transmission, to nigeria (22 july 2014). isolated incidences were also reported in senegal (29 august 2014),7 8 the united states of america (“u.s.”) (30 september 2014), mali (30 september9 2014), and the uk (29 december 2014). on 8 august 2014, the world health10 11 organisation (“who”) declared the ebola outbreak to be a public health emergency of international concern (“pheic”) in terms of the international health regulations (“ihr 2005”) and because it was an “extraordinary event with public health risks to other countries.” this pronouncement called into action12 the 194 signatory nations to the who to participate in the prevention, surveillance, control, response, and reporting of the disease which had, by then, already reached epidemic status. and, on 18 september 2014, the united13 nations (“u.n.”) security council unanimously adopted resolution 2177, “determining that the unprecedented extent of the ebola outbreak in africa constitutes a threat to international peace and security.” this meeting was14 described as “historic” by the secretary-general as being the first instance where the security council has considered a disease outbreak to be “a threat to international peace and security” and only the second time that the security15 of global public health and international peace and security, 18 am. soc’y int’l l. 1 (2014). 7. ebola virus disease west africa—update, who regional off. afr. (july 27, 2014), http://www.who.int/csr/don/2014_07_27_ebola/en/ [https://perma.cc/dpe2-9aq8]. 8. ebola virus disease update—senegal, who regional off. afr. (aug. 30, 2014), http://www.who.int/csr/don/2014_08_30_ebola/en/ [https://perma.cc/eg7w-6hls]. 9. ebola virus disease—united states of america, who regional off. afr. (oct. 1, 2014), http://www.who.int/csr/don/01-october-20 14-ebola/en/ [ttps://perma.cc/8ka9-k57m]. to date, have been a total of four cases reported and first diagnosed in the u.s. cases of ebola diagnosed in the united states ctrs. for disease control & prevention, https://www.cdc.gov/ vhf/ebola/outbreaks/2014-west-africa/united-states-imported-case.html [https://perma.cc/m5qaj9sh]. 10. ebola virus disease—mali, who regional off. afr. (oct. 31, 2014), http://www. who.int/csr/don/31-october-20 14-ebola/en/ [https://perma.cc/6jq3-45gz]; john m. drake et al., ebola cases and health system demand in liberia, 13 plosbiology 1, 2 (2015). 11. ebola situation report, world health org. (feb. 4, 2015), http://apps.who.int/ebola/ en/ebola-situation-report/situation-reports/ebola-situation-report-4-february-2015. 12. notes on the interim u.s. guidance for monitoring and movement of persons with potential ebola virus exposure, ctrs. for disease control & prevention, http://www.cdc. gov/vhf/ebola/exposure/monitoring-and-movement-of-persons-with-exposure.html [https://perma.cc/m7p7-qudz] (last updated feb. 19, 2016). 13. an epidemic occurs when a disease affects a greater number of persons than usual for the locality or the disease spreads to areas not usually associated with the disease. a pandemic is an epidemic of world-wide proportions. statement on the meeting of the international health regulations emergency committee regarding the 2014 ebola outbreak in west africa, who regional off. afr. (aug. 8, 2014), http://www.who.int/mediacentre/news/stat ements/2014/ ebola-20140808/en/ [https://perma.cc/p4ke-56sg]; drake et al., supra note 10 at 1. 14. s.c. res. 2177, ¶ 5 (sept. 18, 2014). 15. burci and quirin suggest that resolution 2177 “represents the most cogent recognition 2018] international and operational responses to disease control 249 council has dealt directly with a public health problem—the other being hiv/aids. 16 however, the most recent ebola outbreak will not only be remembered for this “historic” adoption of u.n. security council resolution 2177. the most recent evd outbreak will also be remembered for what has been described as the “criminally late” response of the who in recognising the potential severity of the outbreak and in reacting timeously with the necessary, appropriate, and effective measures. according to the most recent who situation report, a total of over17 18 28,616 reported, confirmed, probable, and suspected cases of evd and over 11,310 deaths have been recorded in the three most affected countries: guinea, liberia, and sierra leone. in the last report in which specific statistics on health19 worker infections were included, it was stated that a total of 881 confirmed health worker infections have been reported in these three countries and that 513 of these health workers had succumbed due to the infection. and, although the20 most recent evd outbreak is now generally regarded as having been contained, it is also important to note that due to widespread under-reporting, the true number of infections and fatalities will never really be known and is widely believed to be considerably higher.21 much has already been written on this most recent evd outbreak—evaluating and dissecting the contributions and failings of the various role-players involved, and considering what can be done differently in future. this article will contribute to this important and ongoing debate and will specifically focus on the international, operational, and national legal frameworks in terms of which large-scale health crises like that of ebola play out. it will be argued that the very culture and architecture of this transnational legal and operational framework for public health emergencies is isolated from the national realities in which it operates and merely offers a hierarchical authority of what legally ought to be done, with little regard to what is actually necessary and to date of the security implications of widespread outbreaks of lethal infectious diseases.” burci & quirin, supra note 6. 16. see s.c. res. 1308 (july 17, 2000); s.c. res. 1983 (june 7, 2011); burci & quirin, supra note 6. 17. marc dubois et al., the ebola response in west africa: exposing the politics and culture of international aid, humanitarian pol’y group (oct. 2015), https://www.odi.org/ sites/odi.org.uk/files/odi-assets/publications-opinion-files/9903.pdf [https://perma.cc/a66l-9dc7]. 18. situation report: ebola virus disease, who regional off. afr. (june 10, 2016), http://apps.who.int/iris/bitstream/10665/208883/1/ebolasitrep_10jun2016_eng.pdf?ua=1 [https://perma.cc/r5es-c4m8]. 19. drake et al., supra note 10, at 8 (noting that the fatality rate for those cases with known clinical outcome is around 70%). 20. ebola situation report–30 september 2015, who regional off. afr. (sept. 16, 2015), http://apps.who.int/ebola/current-situation/ebola-situation-report-30-september-2015 [https://perma.cc/cv6k-qkhz]. 21. drake et al., supra note 10, at 2. 250 indiana health law review [vol. 15:247 possible on the ground. in considering the most recent ebola outbreak, and juxtaposing it with the severe acute respiratory syndrome (“sars”) outbreak of 2003, it will be shown that a more nuanced transnational legal understanding of public health emergencies is indeed needed—a holistic approach that goes beyond biomedical/scientific and legalistic confines in dealing with disease outbreak and control. it is again important to emphasise here, for the sake of clarity, that this article is exclusively focused on the transnational legal and operational framework in which public health emergencies play out. international humanitarian responses, general public health considerations, as well as other national systemic considerations—like those relating to health systems—although important, will not be considered here. a brief interlude on the methodology of this article also deserves a place here. as already indicated above, much literature exists on the ebola outbreak, and with the attention now shifting to the zika virus, it is important to further distinguish the contribution of this article. this article utilizes a primarily transdisciplinary lens in narrating the rise and fall of two notable epidemics of the modern world. a variety of sources, from different disciplines and bases, are used in presenting an easily accessible text that recounts key themes of both epidemics—highlighting similarities and differences, and raising important questions for the future. as with most narrative research methodologies, reliance is also placed on newspaper articles in constructing an account of how the two epidemics played out, each in its own particular time and space. the disease22 narrative ultimately presented in this article, therefore simultaneously serve as a chronical of the two epidemics, while also reflecting why a more nuanced transnational legal understanding of public health emergencies is indeed needed. to facilitate this discussion and analysis, the content of this article is divided into four parts. first, in part ii, the lifecycle of two epidemics will be considered, ebola, and the 2003 sars outbreak. considering these two outbreaks and the international legal responses thereto provides a valuable lens through which the multiple layers of disease outbreaks and control from the past to the present can be observed. in part iii, this paper provides an overview of the international legal and operational framework for public health emergencies, confined to references and examples from the two outbreaks selected for and discussed in part ii. part iv considers the national legal responses of those countries most affected by the recent ebola outbreak and the 2003 sars outbreak. part v discusses the question of whether to quarantine or not. part vi discusses lessons to be learned, and why knowledge production beyond disciplinary confines is necessary. and finally, part vii of this article concludes with a critical analysis of two observed failings of the current international legal and operational framework for public health emergencies. in considering the shortcomings of the current framework it will be argued that a more holistic approach to disease control is required that looks beyond disciplinary confines. 22. jon d. lee, an epidemic of rumors: how stories shape our perceptions of disease 9 (2014). 2018] international and operational responses to disease control 251 ii. ebola and sars as narratives of infection diseases, epidemics, and public health emergencies a. ebola: forty years in the making of an epidemic the unfolding events of the twentieth major global evd outbreak stands in 23 stark contrast to the first recorded outbreak of evd in 1976 in sudan and the democratic republic of congo (then zaire), and not for the obvious reasons. one would imagine that with the advances in medical technology as well as the knowledge gained from the various major and individualized or isolated cases of ebola infection over the past forty years that we would have been well-prepared when the most recent outbreak was confirmed on 23 march 2014. we were not, and considering the collective evd literature available, it seems as though we have made little progress since 1976 with regard to the response to, and management of, this infectious disease. the first outbreak of the acute viral haemorrhagic fever occurred between june and november of 1976 in southern sudan, with a reported 284 people infected and a 53% infected mortality rate (151 people died). the first24 identifiable case in sudan was that of a storekeeper in a cotton factory who became ill on 27 june 1976, and died in hospital on 6 july 1976. patients25 presented with influenza-like symptoms, including fever, headache, and joint and muscle pains, and eventually with diarrhea, vomiting, chest pain, pain and dryness of throat, and a rash. seventy-one percent of the infected patients also had haemorrhagic manifestations. the source town of this outbreak in sudan26 was nzara, which is also believed to have been the source of infection for the outbreak in the bumba zone of zaire, although the link between these two outbreaks could never be established conclusively. 27 the outbreak in zaire raged only a number of weeks, from 1 september28 1976 to 24 october 1976, and was localized in the bumba zone of the equateur region, with most cases recorded within a radius of seventy kilometers of yambuku. three hundred and eighteen cases were reported with thirty-eight serologically confirmed survivors. patient zero in this zaire outbreak was a fortyfour-year-old male instructor from the local mission school who started to show symptoms on 1 september 1976, five days after having received an injection of chloroquine at the outpatient clinic of yambuku mission hospital for 23. there have been at least thirty-five reported incidences of ebola worldwide from 1976 to date. who ebola response team, ebola virus disease in west africa—the first 9 months of the epidemic and forward projections, 1481 new eng. j. med. 371, 1481-95 (2014). 24. who int’l study team, ebola haemorrhagic fever in sudan 1976, 56 bull. who 247, 247 (1978). 25. id. at 248. 26. id. at 247. 27. id. 28. now the democratic republic of congo. 252 indiana health law review [vol. 15:247 presumptive malaria. within one week, several other patients who had received29 treatment at the clinic for various ailments and diseases also reported the same symptoms. the yambuku mission hospital was eventually forced to close down on 3 october 1976 after eleven of its seventeen medical members of staff had died. 30 much clinical data on evd, or acute viral haemorrhagic fever as it was then referred to, was collected during its first outbreak in sudan and zaire. it was documented, for example, that the incubation period and duration of the disease averaged about one week, that patients presented non-specific symptoms after three to four days, and that some of these non-specific symptoms included a progressively severe sore throat, a maculopapular rash, intractable abdominal pain, and eventually also bleeding from multiple sites, principally the gastrointestinal tract. laboratory tests confirmed that this constellation of31 symptoms was caused by a virus morphologically similar to the marburg virus but immunologically distinct, and it was eventually named the ebola virus—the name of a river close to the yambuku village and a word which translates to “black river” in the local language of lingala. the spread of the virus was32 interrupted by, inter alia, isolating patients in their villages, using protective clothing and respirators, and carefully disposing of potentially contaminated excreta. with regard to possible treatments for the disease, it was reported that33 a total of 201 (200–300 ml each) of plasma containing ebola virus antibodies in titres of at least 1:64 were obtained and frozen, and that these units were used to treat a laboratory worker injected with the ebola virus. since the laboratory34 worker recovered, it was generally accepted that the antibodies may have helped therapeutically. ebola virus antibodies were also found in five other persons35 from the area who were not ill and who did not have any contact with the infected villages or the yambuku hospital during the epidemic. an international36 commission consequently stated in their report to the who in 1976 that “this37 suggests that the virus is in fact endemic to the region and [that this] should lead 29. int’l comm’n rep., ebola haemorrhagic fever in zaire 1976, 56(2) bull. who 271, 278 (1978). 30. id. for a chronology of ebola virus disease outbreaks, see outbreaks chronology: ebola virus disease, ctrs. for disease control & prevention, http://www.cdc.gov/vhf/ebola/ outbreaks/history/chronology.html [https://perma.cc/f4ee-2e8c] (last visited feb. 15, 2018). 31. int’l comm’n rep., supra note 29, at 271. 32. it is interesting to note that many such infectious diseases have been named after rivers. a few include: the crimean-congo hemorrhagic fever named after the congo river, the machupo virus which causes bolivian hemorrhagic fever or black typhus named after a bolivian river, and the mosquito-borne ross river virus which is named after a river in northern queensland, australia. 33. int’l comm’n rep., supra note 29 at 272. 34. id. 35. id. 36. id. 37. id. this commission was established on 18 october 1976 and tasked to report on the outbreak to the who. 2018] international and operational responses to disease control 253 to further effort to uncover a viral reservoir in zaire.”38 the zaire commission described this first outbreak of evd as follows: no more dramatic or potentially explosive epidemic of a new acute viral disease has occurred in the world in the past 30 years. the case mortality rate of ebola haemorrhagic fever in zaire of 88% is the highest on record expect for rabies infection. in the circumstances it was not surprising that much desired information was never obtained. delays in recognition, notification to international health agencies, and specific diagnosis of the disease contributed greatly to this outcome. no better example comes to mind to illustrate the need for national disease surveillance and the prompt solicitation of international assistance, nor of the need for the development of international resources, comprising personnel, equipment, transport, communication, and finance, that can be made available in a very few days to cope with such emergencies.39 the sudanese commission, in turn, recommended that the following procedure be followed once a possible ebola case is identified: first, blood specimens must be collected for diagnosis, then a surveillance system must be put in place to identify other cases of influenza-like symptoms with or without haemorrhagic manifestations. medical staff must wear protective clothing including gowns,40 gloves and masks (or better respirators), and must disinfect patients’ excreta with an effective disinfectant like formaldehyde. a follow-up system must also be41 put in place to check on those with whom the infected persons have had contact and their temperature must be taken daily, isolating them immediately if there is any indication of a fever. once a diagnosis is made, convalescent plasma must42 be dispatched to the geographical areas of concern as soon as possible. the43 commission also stated that “[w]ith such a simple system, these diseases can be identified, isolated, and patients properly treated.” and added that [w]ith experience, no doubt, more outbreaks of these diseases will be identified. we shall probably find that large outbreaks are rare and can be prevented with simple precautions. however, if appropriate precautions are not taken early, as was the case with the first outbreak of viral haemorrhagic fever in sudan, these diseases can spread far and wide, and across international borders. the hospital, especially the referral hospital, is the site where such outbreaks can either be recognised and halted, or unrecognized and disseminated. with them rests the 38. id. 39. id. at 288. 40. who int’l study team, supra note 24, at 255. 41. id. 42. id. 43. id. 254 indiana health law review [vol. 15:247 responsibility for stopping the spread of these dangerous diseases.44 the recommendations of the two commissions are still very relevant today because, as in 1976, no vaccine or cure for ebola exists, and the only way in which to curb the spread of this infectious disease is to break the chains of infection. health workers must therefore identify people who are infected and isolate them from society. this is pivotal to ensure that no further infections take place, either by way of direct contact with the patient and his or her bodily fluids (like blood or sweat which contains high concentrations of ebola particles) or by droplet infection. everybody who has been exposed to the virus (had contact45 with an infected person) must furthermore be identified and then monitored for the onset of symptoms. this is pivotal as ebola is extremely infectious. but while this monitoring of such persons at risk is important, draconian measures, like an outright quarantine order, are not necessary as people infected with the ebola virus only become contagious after they had developed a fever and other symptoms like diarrhea, vomiting, or severe headaches. and, ebola is furthermore only contagious when the person is symptomatic and the first symptom is almost always a fever, which makes the modern day temperature screening at airports particularly effective.46 after the first major outbreaks of evd in the democratic republic of congo (then zaire) and sudan, individualised infections were reported in england and zaire in 1976 and 1977, respectively. the virus was also identified and isolated in the philippines in 1989-1990 in a primate facility responsible for exporting animals to the u.s., and in 1989, 1990 and 1996 at facilities in virginia, pennsylvania, and texas receiving monkeys imported from the philippines. a47 recurrent outbreak with a 65% mortality rate was recorded at the same site in48 nzara south sudan in 1979. however, major ebola outbreaks on the african49 continent were only observed again in 1994/1995, approximately twenty years 44. id. 45. when the virus travels inside droplets of fluid released into the air, for example when a person coughs, it is known as droplet infection. airborne transmission refers to when the droplets carrying the virus dry out and the virus remains airborne travelling on dust particles. another common route of entry is thought to be the wet membrane on the inner surface of the eyelid, which a person may touch with a contaminated fingertip. richard preston, the ebola wars, the new yorker (oct. 27, 2014), http://www.newyorker.com/magazine/2014/10/27/ebola-wars [https://perma.cc/7p75-f4rz]. 46. editorial bd., the dangers of quarantines: ebola policies made in panic cause more damage, n.y. times (oct. 27, 2014), http://www.nytimes.com/2014/10/28/opinion/ebola-policiesmade-in-panic-cause-more-damage.html?_r=0 [https://perma.cc/p9gf-nfkn]. 47. also in 1992 at a facility in italy importing primates from the philippines. see, outbreaks chronology: ebola virus disease, ctrs. for disease control & prevention, http://www.cdc.gov/vhf/ebola/outbreaks/history/chronology.html [https://perma.cc/f4ee-2e8c] (last updated july 28, 2017). 48. id. thirty-four people were infected and twenty-two died. 49. id. 2018] international and operational responses to disease control 255 after the first outbreaks in zaire and south sudan. in 1994, a total of fifty-two people were infected, of which thirty-one died at various sites of gold-mining camps deep in the rainforest of gabon. in 1995, another outbreak in the50 democratic republic of congo claimed the lives of 250 people. in this instance,51 the index patient was identified as having worked in the rainforest adjoining the city of kikwit. further outbreaks in gabon occurred in 1996, 1996/1997 and52 53 2001/2002, in the republic of congo in 2001/2002, 2002/2003 and 2003,54 55 56 57 and in the democratic republic of congo in 2007, 2008/2009, and 2012.58 59 60 another african country, uganda, reported its first incidence of ebola in 2000/2001, and had another outbreak in 2007/2008. and the most recent61 62 outbreak of evd in the democratic republic of congo (“drc”) was in august/november 2014 in multiple villages across the drc, an outbreak that was completely unrelated to the ongoing outbreak of ebola in west africa. 63 given the reports and recommendations by the international commissions to zaire and sudan in 1976—both stressing the need for national disease surveillance and the prompt solicitation of international assistance as well as the prophetic warnings that large outbreaks, while imminent and potentially disastrous, can be prevented with simple precautions—the question can rightly be asked how it is even possible for the public health emergency of the most recent ebola outbreak to have come about. given our experience and knowledge of evd over the past forty plus years, how can it be that the most recent outbreak of ebola got so out of control with a death toll of over 28,000? many possible 50. outbreaks chronology: ebola virus disease, ctrs. for disease control & prevention, https://www.cdc.gov/vhf/ebola/outbreaks/history/chronology.html [https://perma. cc/f4ee-2e8c] (last visited 28 march 2018). 51. id. three hundred and fifteen people were infected and twenty died (81% mortality rate). 52. id. thirty-seven people were infected and twenty-one died (57% mortality rate). 53. id. sixty people were infected and forty-five died (74% mortality rate). 54. id. sixty-five people were infected and fifty-three died (82% mortality rate). 55. id. fifty-seven people were infected and forty-three died (75% mortality rate). 56. id. one hundred and forty-three people were infected and one hundred and twenty-eight died (89% mortality rate). 57. id. thirty-five people were infected and twenty-nine died (83% mortality rate). 58. id. two hundred and sixty-four people were infected and eighty-seven died (71% mortality rate). 59. id. thirty-two people were infected and fifteen died (47% mortality rate). 60. id. thirty-six people were infected and thirteen died (36.1% mortality rate). 61. id. four hundred and twenty-five people were infected and two hundred and twenty-four died (53% mortality rate). 62. id. one hundred and forty-nine people were infected and thirty-seven died (25% mortality rate). other isolated incidences in uganda were also reported in may 2011, june-october 2012 and in november 2012 to january 2013. 63. id. in this latest outbreak in the drc, approximately sixty-six people were infected and forty-nine died (74% mortality rate). 256 indiana health law review [vol. 15:247 factors contributing to the dire state of the current situation have been considered, including the negligent contact tracing of those infected and the inadequate provision for following-up on and checking for symptoms of those who had been exposed to the virus. some also blame the responders who had convinced64 themselves too early that a decline in newly reported cases marked the end of the outbreak; yet others blame the poor flow of information between the affected nations about those infected and those exposed to the virus arguing that this was not only responsible for the chain of illnesses and deaths in sierra leone, but also the second-wave outbreak in late may in liberia. what is clear, however, is that65 it is ultimately the absence of a robust and coordinated response that allowed for an invisible epidemic to thrive alongside the one assumed to be contained. 66 b. sars: a new chapter in the history of infectious diseases? in contrast to the protracted and persistent history of the ebola virus, sars is generally regarded as the first new and serious contagious disease of the twenty-first century. it was first reported in november 2002 in the guangdong67 province of china and became almost an instantaneous global threat as it spread along air-travel routes from china and hong kong to 29 other countries, including taiwan, singapore, canada, vietnam, the philippines and the u.s.68 yet, while the ebola virus has been forty years in the making, with many thousands of people having died in its wake, the sars outbreak was comparatively short and less severe. georges benjamin, the executive director of the american public health association, described it as follows: “…sars was not ‘the big one.’ it did, however, cost over usd $40 billion and served as a global wake-up call.”69 contrary to the mass of information available on ebola before its most recent outbreak, scientists from both the developed and less developed countries were equally unaware as to the cause of sars, the ways in which to diagnose it, the treatments, and the precautionary measures that should be taken to prevent its 64. kevin sack et al., how ebola roared back, n.y. times (dec. 29, 2014), http://www.nytimes.com/2014/12/30/health/how-ebola-roared-back.html?hp&action=click& pgtype=homepage&module=a-lede-package-region&region=top-news&wt.nav=top-news&_r=2 [https://perma.cc/z9lb-9txl]. 65. id. 66. id. 67. grace wong, has sars infected the property market? evidence from hong kong, 63 j. urb. econ. 74, 75 (2008); lawrence o. gostin et al., sars and international legal preparedness, 77 temp. l. rev. 155, 155 (2004). 68. matthew rimmer, the race to patent the sars virus: the trips agreement and access to essential medicines, 5 melb. j. int’l l. 335, 336 (2004); lee, supra note 22, at 9. 69. georges c. benjamin, afterword to timothy j. brookes & omar a. khan, behind the mask: how the world survived sars, the first epidemic of the 21 century 235 (am.st pub. health ass’n 2005). 2018] international and operational responses to disease control 257 spread. this lack of scientific knowledge on the disease was further exacerbated70 by the immense secrecy in which the chinese government initially shrouded its occurrence. it was, for example, only on 10 february 2003, that the who learned from the chinese government about the 305 cases of atypical pneumonia that had occurred in the guangdong province since, at least, november 2002. but the71 world was introduced to sars shortly thereafter (21-23 february 2003), when an elderly professor from guangdong travelled to hong kong to attend a wedding, and infected many other guests at the hotel where he was staying. the guests eventually travelled to vietnam, canada, the u.s., and singapore.72 on 12 march 2003, the who issued a global health alert about a new flu-like disease that seemed to be highly contagious, and on 21 march the chinese government formally requested assistance from the who in investigating the outbreak in guangdong. a who multi-centre collaborative network on sars73 aetiology and diagnosis was subsequently established with a network of scientists, doctors and health professionals working around the clock to identify the cause of this new disease, to develop appropriate diagnostic tests, define clinical features, and investigate its modes of transmission. on 14 april 2003,74 canadian scientists successfully sequenced the dna of the then yet unknown coronavirus, and today we know that sars is a form of atypical pneumonia caused by a new strain of the coronavirus, which is generally referred to as the sars virus (“sars-cov”). it is believed that sars-cov is an animal virus75 that crossed the species barrier to humans due to ecological changes and changes in human behavior that increased human exposure to the virus and also fostered virus adaptation ultimately enabling human-to-human transmission. the animal76 reservoir for the sars-cov pathogen is furthermore believed to be vast, and includes wildlife species like the himalayan masked palm civet, the chinese ferret badger, and the raccoon dog, all of which are consumed as delicacies in southern china. domestic cats and ferret have also been found to be infected with, and able to infect other animals with, the sars virus. curiously, patient77 zero for the 2003 sars outbreak is believed to be a shenzhen-based cook who often prepared meals containing meat from animals caught in the wild, and who checked into the futian hospital of chinese medicine on 20 august 2002 after 70. peter k. yu, virotech patents, viropiracy, and viral sovereignty, 45 ariz. st. l.j. 1563, 1590 (2013). 71. lee, supra note 22, at 14. 72. id. 73. id. 74. yu, supra note 70, at 1590-91. 75. rimmer, supra note 68, at 336; lee, supra note 22, at 19. 76. who dep’t of communicable disease surveillance and response, who guidelines for the global surveillance of severe acute respiratory syndrome (sars): updated recommendations, october 2004, at 6 (2004), http://www.who.int/csr/resources/ publications/who_cds_csr_aro_2004_1.pdf?ua=1 [http://perma.cc/5mnx-2fk6]. 77. id. 258 indiana health law review [vol. 15:247 having already infected his wife and two of his sisters.78 the clinical features of sars can range from a severe form of respiratory disease, after which the syndrome was named, to other milder and more atypical (non-specific) flu-like or pneumonia symptoms. a real risk exists for the disease79 not to be correctly diagnosed without supportive epidemiological and laboratory testing; therefore, a high level of awareness about the spectrum of disease caused by sars must always be maintained amongst health professionals, especially in south-east asia where the epidemic originated. sars is transmitted by way of80 respiratory exudates and contaminated surfaces on membranes of the mouth, nose or eyes. the most effective epidemic control measures for this virus is81 therefore—in addition to the early detection, isolation and treatment of those infected—to reduce population contact and promote personal and environmental hygiene.82 the disease is furthermore characterized by rapid transmission and a high mortality rate. for example, in the absence of any control measures, an average83 of two to four people can be infected by each sars patient; in contrast to the ebola virus where the incubation period can be anywhere between two to twentyone days, the incubation period for sars is only ten days. for this reason, the84 potential severity of a sars outbreak should not be under-estimated as the sars virus is sufficiently infectious to cause a very large epidemic if unchecked, but is completely controllable with public health measures such as early detection, quarantine and medical treatment. while much has been learned about the virus,85 knowledge about its epidemiology and ecology remains incomplete; although the most probable sources of infections with sars-cov today would result from exposure in laboratories, the possibility of the re-emergence of sars in epidemic form is not impossible.86 the countries hardest hit by the sars epidemic, which ranged from 1 november 2002 to 11 july 2003, were the people’s republic of china, the87 78. lee, supra note 22, at 18. 79. who dep’t of communicable disease surveillance and response, supra note 76, at 7. 80. id. 81. grace wong bucchianeri, is sars a poor man’s disease? socioeconomic status and risk factors for sars transmission, f. for health econ. & pol’y 1, 4 (2010). 82. id. 83. eugenia tognotti, lessons from the history of quarantine, from plague to influenza, 19 emerging infectious diseases 254, 258 (2013). 84. grant hill-cawthorne & adam kamradt-scott, mandatory ebola quarantine is about politics, not public health, the conversation (oct. 29, 2014), http://theconversation.com/ mandatory-ebola-quarantine-is-about-politics-not-public-health-33531 [http://perma.cc/9w8j3f7r]. 85. bucchianeri, supra note 81, at 4. 86. who dep’t of communicable disease surveillance and response, supra note 76, at 6. 87. cumulative number of reported probable cases of sars, who (july 11, 2003), 2018] international and operational responses to disease control 259 hong kong special administrative region, taiwan, and canada. the who88 89 90 reported that there were 8,437 known cases of sars, with 813 deaths attributable to the sars virus. 91 despite the marked differences in the lifecycle and impact of the 2003 sars outbreak compared to that of the most recent ebola epidemic, remarkable similarities exist. for example, just as the most recent ebola outbreak is still ongoing and is generally described in terms of its failures, the 2003 sars outbreak is far from forgotten and is generally still presented in literature as “a medieval plague, a medical disaster and an economic blight.” similarities also92 exist in the manner in which these two public health emergencies were dealt with. similar to the initial denial of the seriousness of the most recent ebola outbreak by international organisations and national governments alike, there was also a “high-profile denial” by the chinese government, and later also the hong kong authorities about the true nature, seriousness and extent of the spread of sars.93 and to those affected by ebola, residents in hong kong and china were also reported to have felt abandoned and uninformed about the diagnosis, treatment and transmission mechanism of sars, adding to feelings of uncertainty and trepidation in the wake of the disease. 94 by some standards, the sars outbreak was certainly not the most severe of the epidemics that have plagued the world. yet, it reminded us of how real the threat of a global epidemic is, and how vulnerable we still are despite all the medical and technological advances that we have privy to today. the sars outbreak is also noteworthy for another reason; as the first emerging new epidemic of the age of globalization in which we live today, most stakeholders would say that it was contained rather effectively and efficiently in less than four months since its outbreak was announced, which makes the calamity of the most recent ebola outbreak all the more problematic. iii. international and operational legal responses to public health emergencies a. the international legal framework for public health emergencies the first organised institutional responses to disease control date back to the http://www.who.int/csr/sars/country/2003_07_11/en/, [https://perma.cc/n7rw-8rws]. 88. id. 1755 diagnosed cases and 298 deaths. 89. id. 671 diagnosed cases and 84 deaths. 90. id. 250 diagnosed cases and 38 deaths. 91. rimmer, supra note 68, at 336; lee, supra note 22, at 57; cumulative number of reported probable cases of sars, who (july 11, 2003), http://www.who.int/csr/sars/ country/2003_07_11/en/, [https://perma.cc/n7rw-8rws]. 92. rimmer, supra note 68, at 336. 93. wong, supra note 67, at 77. 94. id. 260 indiana health law review [vol. 15:247 plague epidemic of 1347-1352. initially these responses were locally based and95 focused, but as technological advances improved, the available means of transport and drastically decreased travel time, and the establishment of new ports and port cities spurred possibilities for trade. the ensuing mobilisation of people called96 for collaborative networks to regulate and control the spread of disease. the first english quarantine regulations were drafted in 1663, and the english quarantine act was promulgated in 1710 and revised in 1721, 1733, and again in 1743. it97 was also during this time that a system of active surveillance for infectious diseases was established in the major levantine cities and a network for infectious disease control was established with representatives from various countries connecting the great mediterranean ports of western europe.98 with the spread of asiatic cholera to europe, efforts at international health cooperation culminated with the first international sanitary conference in paris on 23 july 1851. the objective of this conference, and the conferences that were99 to follow, was to reach agreement on the measures to be taken to limit the100 spread of epidemic diseases, and it provided a “unique forum for the international exchange of ideas between medical administrators and medical scientists of different nations and cultures.” howard-jones describes the printed records of101 these conferences as constituting “a living history of the different conceptions of the nature of epidemic diseases held during the latter half of the nineteenth century and immediately [there]after.” howard-jones also observed that the102 records show “how scientific knowledge that has been painfully won may be 95. b. mafart & j.l. perret, history of the concept of quarantine [in french], 58 (2 supp.), med trop (mars) 14, 14 (1998). 96. tognotti, supra note 83, at 255. 97. id. 98. id. see generally carlo m. cipolla, fighting the plague in seventeenth-century italy (u. wis. press 1981). 99. the nation states present at this conference included eleven european states—papal, sardinia, tuscany, the two sicilies, austria, great britian, greece, portugal, russia, spain and france—as well as turkey. norman howard-jones, the scientific background of the international sanitary conferences 1851-1938, at 9 (geneva: who 1975). 100. the second conference took place eight years later in 1859 in paris and were followed by conferences in constantinople (1866), vienna (1874), washington (1881), rome (1885), venice (1892), dresden (1893), paris (1894), venice (1897), paris (1903), paris (1911-1912), paris (1926) and paris (1938). see the following sources for a more in-depth overview of the content of each conference and the role that they collectively played in establishing an international health security body, the who. valeska huber, the unification of the globe by disease? the international sanitary conferences on cholera, 1851-1894, 49 hist. j. 453-476 (2006); morton a. kramer et al., international health security in the modern world: the sanitary conventions and the world health organisation, dep’t st. bull. (1947); who, the first ten years of the world health organisation (geneva: who 1958). 101. howard-jones, supra note 99, at 9. 102. id. see generally huber, supra note 100. 2018] international and operational responses to disease control 261 forgotten and, decades later, rediscovered.” for example, while the concepts103 of convalescent cholera carriers, of mild or unapparent infections, and of the gall bladder as a reservoir of cholera vibrios were trumpeted as new discoveries in the 1960s, the records of the conferences actually show that these concepts were already universally accepted “some sixty or more years ago.” this phenomenon104 is also evident from the historical overview on the ebola virus provided above, where it was evident that our experience and knowledge of evd accumulated over the past forty years was easily “forgotten” and did little to ensure appropriate, timeous, and effective action with the most recent outbreak. a case in point is an article published in the lancet on 9 may 2015 in which it is said that “[t]he unfamiliarity of ebola delayed its detection.” this is simply not true.105 for four decades, these “sanitary” conferences failed to produce on its promise of delivering internationally agreed upon standards for the regulation and control of infectious diseases due to the “utter ignorance of the causes of the epidemic diseases . . . [proving] . . . an insuperable barrier to international agreement.” however, “as the etiologies of cholera, then plague, and later106 yellow fever were unraveled, the pace of international health cooperation quickened, leading to the foundation, one after the other, of the pan american sanitary bureau, the office international d’hygiène publique, the health107 organization of the league of nations, and, finally, the world health organization, which incorporated all its predecessors.” the who was108 established in 1948, three decades after the influenza pandemic of 1918—the most deadly pandemic ever recorded.109 the constitution of the who was adopted by the international health 103. howard-jones, supra note 99, at 9. 104. id. 105. lawrence o. gostin & eric a. friedman, a retrospective and prospective analysis of the ebola virus disease epidemic: robust national health systems at the foundation and an empowered who at the apex, 285 lancet 1902, 1902 (2015). 106. howard-jones, supra note 99, at 9. 107. this was the first non-regional international health organization. it was established on 3 december 1907 in rome and had its last session on 21 april 1914, before the first world war. 108. howard-jones, supra note 99, at 9. 109. see jeffery k. taubenberger & david m. morens, influenza: the once and future pandemic, 125 (suppl 3) pub. health rep. 16-26 (2010). it is important to differentiate between an “outbreak,” “epidemic,” and a “pandemic.” when the rate of infections and fatalities associated with a particular disease bypasses the existing control measures, it is often referred to as an outbreak. the term “outbreak” is therefore used to describe the sudden rise in the incidence of a particular disease. an outbreak can often lead to an epidemic, which the u.s. centers for disease control and prevention defines as “[t]he occurrence of more cases of disease than expected in a given area or among a specific group of people over a particular period of time.” a pandemic, in turn, is an extensive epidemic that is rampant in a country, continent or the world. an endemic disease refers to a disease native to a particular group or region, a disease that is regularly or constantly found among people of a specific region. 262 indiana health law review [vol. 15:247 conference with representatives from sixty-one states on 22 july 1946, and entered into force on 7 april 1948. today, the who has 194 signatory nations110 who all accept and agree to the basic principles on which the who is based for the purpose of fostering and enabling co-operation amongst member states in order to promote and protect the health of all peoples. these principles include a commitment to health as a state of complete physical, mental, and social wellbeing, and the enjoyment of the highest attainable standard of this health as a fundamental right of every human being. the objectives of the organization111 are set out in article 2 of its constitution which confirms the who’s coordinating authority and duty to establish and ensure effective collaboration between member states, and to provide technical, normative, material and operational support in all matters related to health, including public health issues in general, and health emergencies specifically. the who has certainly112 developed into a (potentially) powerful institution from its early years with only sixty-one members to today, with its headquarters in geneva, six strategically positioned regional offices, and representation by more than 7,000 people—including medical doctors, public health specialists, scientists and epidemiologists—from over 150 countries, territories and areas.113 with the recent ebola outbreak, the who collaborated with the u.n. mission for ebola emergency response (“unmeer”) and u.n. agency partners like unicef, wfp, ocha, unfpa and undp, as well as other international partners like the african union, the u.s. centers for disease control (“cdc”), msf, the international federation of the red cross (“ifrc”), the international organization for migration (“iom”), unaids, and partners of the global outbreak alert and response network (“goarn”). an ebola response roadmap was also drafted by the who in august 2014, setting out the primary strategy for curbing the ebola outbreak and to provide the basis for a significantly increased response. this was followed by the u.n.’s overview of needs and114 requirements (“onr”) and the stepp strategy which “were designed to assist governments and partners in the revision and resourcing of country-specific operational plans for the ebola response, and to aid the coordination of international support to fully implement those plans.” 115 a particularly important and historic development in terms of the legal 110. constitution of who: principles, who, http://www.who.int/about/mission/en/ [http://perma.cc//557l-58kw] (last visited feb. 16, 2018). 111. who, basic documents: constitution of the world health organization, 48 who 7 (2014), http://apps.who.int/gb/bd/pdf/bd48/basic-documents-48th-edition-en.pdf#page=7 [https://perma.cc/7ccn-75hs]. 112. id. at 8. 113. who, about who: who people and offices, http://www.who.int/about/structure/en/ [https://perma.cc/l9nx-n5az] (last visited feb. 16, 2018). 114. who, 2015 who strategic response plan: west africa ebola outbreak 5 (who 2015), http://apps.who.int/iris/bitstream/10665/163360/1/9789241508698_ eng.pdf?ua=1&ua=1 [https://perma.cc/3qb8-zxm9]. 115. id. 2018] international and operational responses to disease control 263 framework for the regulation of public health emergencies that emerged during the most recent ebola outbreak must again be emphasized here. after the u.n. security council unanimously adopted resolution 2177 on 18 september 2014—“determining that the unprecedented extent of the ebola outbreak in africa constitutes a threat to international peace and security” —the first ever116 u.n. emergency health mission, the unmeer, was established. unmeer117 was established as a temporary measure to meet immediate needs with regard to the ebola outbreak and assumed a coordinating function for u.n. entities that operate in the outbreak area. the unmeer strategy was based on three pillars of action: immediate outbreak response, enhanced coordination and collaboration, and the mobilization of increased human and financial resources. in areas with118 intensive transmission, a “stepp” approach was applied: (1) stop the outbreak; (2) treat the infected; (3) ensure essential services; (4) preserve stability; and (5) prevent further outbreaks. this was supplemented with further targets and119 timelines and given its contemporaneous establishment, unmeer basically had to define itself and its approach in the midst of the full-blown emergency. 120 much more can be said about the coordination bodies and mechanisms that inhabit the top echelons of our international society on matters relating to health, and, for the purpose of this paper, public health emergencies. indeed, some aspects of the international legal framework for public health emergencies will again be considered in part iv below, for now, the remainder of the discussion in part iii will rather focus on the international health regulations (2005); the most important and only existing international legal instrument for the management and coordination of large-scale public health emergencies.121 b. the international health regulations (ihr 2005) article 21 of the constitution of the who empowers the world health assembly—the highest decision-making body of the who—to adopt regulations on matters including those related to “sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease.”122 116. s.c. res 2177 (sept. 18, 2014). see resolution 2177 (2014): adopted by the security council at its 7268 meeting on 18 september 2014 at 1, u.n. security council (2014),th http://www.un.org/en/ga/search/view_doc.asp?symbol=s/res/2177%20 [https://perma.cc/43dpqmcf]. for the who’s response to the adoption of the resolution, see who welcomes decision to establish united nations mission for ebola emergency response, who media ctr. (sept. 19, 2014), http://www.who.int/mediacentre/news/releases/2014/ebola-emergency-response/en/ [https://perma.cc/wl4n-x8ha]. 117. see generally burci & quirin, supra note 6. 118. dubois et al., supra note 17, at 25. 119. id. 120. id. at 27. 121. id. at 28. 122. basic documents: constitution of the world health organization, who 7 (2006), 264 indiana health law review [vol. 15:247 article 22 of the constitution furthermore provides that such regulations will be binding on all who member states unless they advise the director-general of their rejection or reservation. pursuant to these provisions, a series of the123 international sanitary conventions adopted in the second half of the nineteenth century, and which was later consolidated into the 1951 international sanitary regulations was renamed as the international health regulations (“ihr”) in124 1969 and was the first—and only—binding international legal instrument on global disease surveillance and control.125 the ihr (1969) was limited in scope and only dealt with specific diseases, namely, the plague, cholera and yellow fever. the regulations to the ihr126 (1969) set out measures to be taken by the member states to prevent the spread of disease, and it also prescribed minimum standards for sanitation and public health facilities at air and sea ports. provisions were also made for prescribed127 mandatory and permitted health measures as well as maximum measures that must be applied during times of an epidemic. for example, part iv of the ihr (1969) contained provisions on the restrictions to be imposed on inbound and outbound international travel or movement of goods, and article 23 provided for, inter alia, the application and/or prohibition of certain measures under specific circumstances. 128 while this first version of an internationally agreed-upon and binding legal instrument for global disease surveillance and control was indeed a significant development in global health at the time, it also proved to be wholly inadequate and unsatisfactory. the most obvious shortcoming was the limited scope of the ihr (1969) and its regulations. the hiv/aids pandemic, the sars epidemic, and the threat of an influenza pandemic, for example, fell outside the scope and operation of the ihr (1969). states’ compliance with the ihr (1969) were129 poor; given that the who is dependent on notifications and information by states in order for it to fulfill its technical, normative and operational functions, the noncompliance of states rendered it effectively useless. but while member states130 were in agreement that the ihr (1969) had to be revised, the discussion and the consultation processes were protracted—similar to the sanitary conventions discussed in the preceding sections—and it was only after the sars epidemic in 2003 and the growing fears of avian influenza and a possible large-scale influenza http://www.who.int/governance/eb/who_constitution_en.pdf [https://perma.cc/sud2-u7gf]. 123. id. see also barbara von tigerstrom, the revised international health regulations and restraint of national health measures, 13 health l.j. 35, 36 (2005). 124. see infra section ii section for a discussion on the sanitary conventions. 125. von tigerstrom, supra note 123, at 36. 126. international health regulations 1969, who geneva (1983), http://www.who.int/csr/ ihr/ihr1969.pdf [https://perma.cc/gsq3-sa8a]. 127. id. at 14-16. 128. von tigerstrom, supra note 123, at 36-37. 129. id. at 37. 130. id. 2018] international and operational responses to disease control 265 pandemic that the provisions of ihr (2005) were ultimately agreed upon.131 thus, while the most recent ebola outbreak brought us the “historic” pronouncement by the u.n. security council and the establishment of unmeer (although only temporarily), the 2003 sars outbreak was the catalyst for the revised international health regulations (2005) (“ihr (2005)”) that is currently in place and that is described as “one of the most radical and far-reaching changes to international law on public health since the beginning of international health co-operation in the mid-nineteenth century.” as was indicated in part ii above,132 the sars 2003 outbreak was indeed not one of the most severe epidemics that the world has ever had to face, but it is generally regarded as the “first severe and readily transmissible new disease to emerge in the twenty-fist century” and it placed under the spotlight the potentially catastrophic reality of infectious disease in a globalized world.133 after consultations and submissions by member states, the ihr (2005) was adopted in may 2005 and came into force in june 2007. the ihr (2005), as we know it today, constitutes a thorough revision of the previous regulations pertaining to disease control adopted by the world health assembly under article 21 of the who constitution since 1951, and is a legally-binding instrument that 196 countries have since agreed to and signed. interesting134 similarities and differences between the ihr (1969) and the ihr (2005) exist. the stated objective of the revised ihr (2005) is, for example, similar to that of the ihr (1969) and is articulated in article 2; the ihr (2005) is geared towards the prevention, protection against, control and the providing for a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. 135 numerous important differences between the ihr (1969) and the ihr (2005), however, can also be observed. for example, the scope of the ihr (1969) was limited to only three diseases, but the scope of the ihr (2005) is centered on notions of “events” or on a “public health emergency of international concern” which not only applies to the spread of natural diseases, but also to the accidental or intentional release of biological, chemical, or radiological agents if it could lead to the international spread of disease and irrespective of origin or source.136 the range and nature of disease events covered under the ihr (2005) are 131. id. at 38. 132. see david p. fidler, from international sanitary conventions to global health security: the new international health regulations, 4 chinese j. int’l l. 325 (2005). 133. von tigerstrom, supra note 123, at 38. 134. see generally burci & quirin, supra note 6; fidler, supra note 132. 135. wha58.3 revision of the international health regulations, world health assembly (2005), http://www.who.int/ipcs/publications/wha/ihr_resolution.pdf. [https://perma.cc/blq69cq4]; international health regulations, second edition, who, (2008) http://www.who.int/ihr/ publications/9789241596664/en/ [https://perma.cc/2pjz-bedw]. 136. burci & quirin, supra note 6. 266 indiana health law review [vol. 15:247 therefore much broader in scope. member states are required to notify the who of all events that may constitute a pheic based on the decision instrument set out in annex 2 of the ihr (2005). annex 2 presents an algorithm of a series of137 questions and when an affirmative answer exists on any two of these questions the member state must notify the who. the annex also contains a lists of138 diseases to which the algorithm must always be applied, as it is either presumed that these diseases are always potentially of international concern or it is presumed that the occurrence of these diseases is both unusual or unexpected and serious, and should therefore be classified as a pheic. viral haemorrhagic139 fever—a disease under which ebola can be classified and which was discussed in part ii—is one of the diseases listed in annex 2 of the ihr (2005). the authority to determine whether an event constitutes a pheic is vested in the director-general of the who, in terms of article 12 of the ihr (2005), and in consultation with the reporting state as well as the recommendation and advice of an “emergency committee” of public health experts. upon declaring a140 pheic the director-general can issue temporary recommendations of urgent measures to prevent or control the international spread of disease. these temporary recommendations are not binding but present authoritative guidance and enhance accountability by requiring states who do not adhere, to justify their actions.141 key in the ihr (2005) is the translation of the global ethos for health put forward by the who, in terms of the national public health capacities of member states. while the ihr (1969) merely contained a limited set of prescriptions for organization, equipment, facilities, and services required at national ports and airports (part iii of the ihr (1969)), the ihr (2005) also requires of its signatorystates to take a number of measures to prevent, respond, and to control the spread of disease and to implement these obligations within its domestic legal and public health systems. it is particularly important that the ihr obligations are incorporated and implemented in national legal and public health systems as it not only gives effect to the objectives of the ihr, but also provides the much needed “framework (or backbone) for a range of public health activities and specific operational functions.” the core capacities or minimum set of standards for142 137. world health assembly, supra note 135; international health regulations, second edition, supra note 135. 138. world health assembly, supra note 135; international health regulations, second edition, supra note 135. where member states are faced with a potential health situation of international concern it must first ask whether the public health impact of the event is serious. second, whether the event is unusual or unexpected, third whether there is a significant risk of international spread and finally whether there is a significant risk of international travel or trade restrictions. 139. world health assembly, supra note 135; international health regulations, second edition, supra note 135; see von tigerstrom, supra note 123, at 39. 140. burci & quirin, supra note 6. 141. id. 142. ana ayala & tanya baytor, ebola: the global health tragedy of our times and how 2018] international and operational responses to disease control 267 public health surveillance and response that signatory states must incorporate and implement in their national systems include the following: • establishing a specific mechanism to enable timely notification to the who of public health risks that could potentially become an international public health emergency; • making sure that national legislation and policy allow for the implementation of the ihr; • ensuring that funding is available for carrying out all necessary activities; • developing proper surveillance systems and response plans; • establishing laboratory services; and • having the necessary human resources for carrying out activities.143 whether states have implemented, and how states have fared in meeting their obligations in terms of the development of their national public health capacities in terms of the ihr (2005) is an important consideration, especially in light of the contributory nature of the inadequate national health systems of guinea, liberia and sierra leone during the most recent ebola outbreak. it was evident from the discussion in part iii above that the lack of consensus on the biomedical causes of epidemic diseases initially proved an insuperable barrier to international agreement. this is certainly no longer the case today. the ihr (1969), in turn, was limited in scope and completely irrelevant to the 2003 sars outbreak, yet the response to sars is generally considered to be a success story for both the who and the international community at large. however, while the ihr (2005) is described as “unprecedented in the history of the relationship between international law and public health,” and was fully operational during the most recent ebola outbreak, the international response and coordination was found to be wholly inadequate and lacking. 144 iv. national legal responses to public health emergencies there are, of course, many factors that exist locally, at the heart of an epidemic, that contribute directly to the spread (and curb) of infectious diseases and other public health emergencies. some of these factors are related to political regimes and histories, governance, health financing and health systems, or to the availability of essential medicines, supplies and delivery services. yet others relate to human resources, education, and specific social and cultural features of law is essential in preventing public health catastrophes, o’neill inst. for nat’l & global health (apr. 9, 2014), http://www.oneillinstituteblog.org/ebola-global-health-tragedy-times-lawessential-preventing-public-health-catastrophes/?utm_content=bufferdac26&utm_ medium=social&utm_source=twitter.com&utm_campaign=buffer [https://perma.cc/3admyrgm]. 143. id. 144. david fidler & lawrence o. gostin, the new international health regulations: an historic development for international law and public health, 34:1 j. l., med. & ethics 93 (2006). 268 indiana health law review [vol. 15:247 the affected societies. there are also numerous challenges that can obstruct public health interventions in the face of an epidemic, including “fear of stigmatization in the community, delays in seeking treatment, inadequate triage in hcfs, lack of recognition of ebola cases, and incomplete identification and follow-up of some contacts.” moreover, the following motivations for denying ebola145 symptoms and resisting treatment during the most recent outbreak included stigma, fear, mistrust, and low medical literacy.146 while much scholarly research has since been devoted to these and other contributory factors, the contribution of this particular section of the article will be limited to an evaluation of the national legal responses to public health emergencies, and particularly the use of quarantine measures and bylaws as instruments of behavioural change. it will be shown in this section that these national legal responses to public health emergencies are not always properly informed and tailored to meet the needs and circumstances of the communities they are intended to serve, nor are they necessarily warranted in terms of biomedical evidence. national legal responses to public health emergencies are rather often informed by fear and based on distrust, the effects of which move across time, space, and boundaries within and between international and national actors, communities, and individuals. it will be evident from the discussion147 below that actors often leverage scientific uncertainty according to their political interests. 148 a. bylaws as instruments of behavioral change in trying to curb the further spread of evd in sierra leone, the remote149 areas of kailahun, kenema, and koinadugu adopted the central government’s emergency state laws, which were declared on 31 july 2014 and extended twice in combination with district/chiefdom bylaws. these bylaws aimed to bring150 about behavioural change by limiting public movement and association, and by 145. nyenswah tolbert et al., controlling the last known cluster of ebola virus disease – liberia, january-february 2015, ctrs. for disease control & prevention, https://www.cdc. gov/mmwr/preview/mmwrhtml/mm6418a5.htm?s_cid=mm6418a5_w [https://perma.cc/u9g4t4z9]. 146. id. 147. dubois et al., supra note 17, at 31. 148. jonathan e. suk, sound science and the new international health regulations, 1:2 global health governance 1 (2007). 149. nathaniel king, home-grown good practice responses to ebola in sierra leone, (oct. 22, 2014) (unpublished research report). for a summary, see http://www.ebolaanthropology.net/wp-content/uploads/2014/11/homegrown-responses-to-ebola-sierra-leone-29october-2014.pdf [https://perma.cc/ymd9-l8vx]. 150. id. at 9. see generally paul richards et al., village responses to ebola virus disease in rural central sierra leone, njala u. (jan. 12, 2015), https://lists.capalon.com/ pipermail/ebola-anthropology-initiative/attachments/20150121/c7ae55ff/attachment.pdf [https://perma.cc/v3vs-ntkn]. 2018] international and operational responses to disease control 269 prohibiting certain customary and informal practices of local peoples in caring for the sick and dying. examples of the sanctions imposed on breaching these bylaws included the following: a person could incur a fine of up to 200,000le for tending a sick person in their home or a fine of 500,00le for washing the body of a deceased person. it was submitted that “the risk of [such] immediate and151 locally enforced penalties” proved to be effective “even when the threat of severe health consequences for the behavior is not.” yet, it has been observed that152 these bylaws had more force as a deterrent than as punitive instruments.153 generally speaking and for the remote areas of sierra leone specifically, these bylaws proved to be effective to a certain extent in forging behavioural change. its success was ascribed to the following factors: the residents of these areas are accustomed to the passage of informal bylaws by chiefs, and “the psychological frame and infrastructure” of enforcement and the collection of fines already existed before the bylaws came into existence. the district councils,154 local councilors, and paramount chiefs of these districts also collaborated, adopted each other’s best practices, and crafted and implemented the bylaws as a united and legitimate source. the remoteness of these three areas from the155 capital freetown and the reach of central government actors are not only in terms of geography and distance; there is also an emotional distance. many residents in especially the kailahun and koinadugu districts “do not feel the presence of the state in their collective and individual lives.” the state’s legal influence is156 therefore weakest in these areas, making the role and authority of chiefs and local councils officials all the more important. the situation in kenema and kailahun157 was, for example, described in terms of a “siege mentality… [where] the chiefs and the local councils officials performed their way into the collective consciousness of the people in their communities. it was as if the people obeyed the bylaws because they (the bylaws) were creations of the community compatriots who, like them, were helping to fight this disease.”158 what is interesting, however, is that insofar as these bylaws related to changing customary burial practices, effecting behavioural change proved to be more difficult. in fact, it is estimated that up to one half of ebola related deaths 151. king, supra note 149, at ii. 152. id. 153. id. at 5. 154. id. at ii, 4. 155. id. at 10. 156. id. at 5 (noting that a similar distrust in the government and a strong sense of community belonging also exists in certain rural areas of liberia). see generally melissa minor peters, community perceptions of ebola response efforts in liberia: montserrado and nimba counties, oxfam gb (dec. 18, 2014), https://lists.capalon.com/pipermail/ebola-anthropology-initiative/ attachments/20150121/c7ae55ff/attachment-0001.pdf [https://perma.cc/eg3x-etc3]. 157. king, supra note 149, at 5. 158. id. at 5, 9-10. 270 indiana health law review [vol. 15:247 in sierra leone were caused by unsafe burial practices. in an assessment of159 burial practices, cemetery management, and adherences to practices recommended to reduce the risk for ebola virus transmission, the cdc in collaboration with the sierra leone ministry of health and sanitation (“moh”) found, inter alia, that the recommended “safe” burial practices were not well accepted by communities. community and family members were concerned160 about the deceased being buried in unmarked graves or with multiple bodies in the same grave. such practices were considered “undignified and unacceptable to the community.” interviews with community and family members also161 revealed that many people continued to deny that ebola was real and were not aware of the risk for ebola transmission from contact with an infectious dead body. 162 with regard to chinese burial customs in hong kong specifically, it can be noted that the veneration of family ancestors is, similar to many african cultures, also important. however, contrary to the situation in the rural african163 communities described above, the congested landscape of hong kong and the relatively high fees for burial in a private as opposed to a public cemetery, as well as the legally sanctioned and compulsory exhumation of remains buried in public cemeteries after a period of six years, has considerably influenced traditional burial rites. while the support and authority of chiefdom leaders and164 community elders was important in convincing community members of the necessity of deviating from customary practices during the ebola outbreak in 159. mark a. rothstein, from sars to ebola: legal and ethical considerations for modern quarantine, 12(1) ind. health l. rev. 227, 253 (2015). 160. carrie f. nielsen et al., improving burial practices and cemetery management during an ebola virus disease epidemic–sierra leone, 2014, ctrs. for disease control & prevention , https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6401a6.htm?s_ cid=mm6401a6_w [https://perma.cc/tps3-w7jq]. 161. id. 162. id. see generally briefings and guides: management of the dead, ebola response anthropology platform (last visited feb. 26, 2018), http://www.ebolaan th ro p o lo gy.n e t / th eme/man agement-o fth e-dead /?p o s t_ type=key_ messages [https://perma.cc/fj3b-hs7v] (describing detailed anthropological narratives on culture and burial practices in the most recent ebola outbreak). 163. b.d. wilson, chinese burial customs in hong kong, 1 j. royal asiatic soc’y h.k. branch 115 (1961), https://jstor.org/stable/23881299 [https://perma.cc/2qlf-bq5q]; see also choi-king katie ching et al., culture and land use: a study of burial policy in hong kong, u. h.k. (1986), https://hub.hku.hk/r44qnl1u9s/eyjhbgcioijiuzi1niisinr5cci6ikpxvcj9. eyjuyw1lijoinwjimwq1yjeilcjlbwfpbci6ijc5otvmndg2mwu1ogmwymflotcynjg 4mgy2mgm3yiisimhhbmrszsi6ijewnziylzi2mdy1iiwic2vxijoimsisimlhdci6mtuxod c1mti5nswizxhwijoxnte4odm3njk1fq.myqqtkp-i7m3om7er4hsuoocl1kd3qxsxny aqu9jqxi/fulltext.pdf [https://perma.cc/qea8-fhcu]. 164. see generally wilson, supra note 163; h.k. food & envtl. hygiene dep’t, a guide to after death arrangements (2017), http://www.fehd.gov.hk/english/cc/die_todo_e.pdf [https://perma.cc/r53p-2wq8]. 2018] international and operational responses to disease control 271 africa, similar concerns were not as prevalent in hong kong during the sars outbreak. not only is the epidemiology of these two infectious diseases obviously different, but in hong kong, people usually die in hospitals or other care facilities and their remains are removed and taken care of by the assigned public health services or a funeral parlour. thus, a national standard operating procedure165 (“sop”) that takes into account specific customary needs and cultural rituals, and includes—for as far as possible—community and family members in the burial process, was not as significant for hong kong during the sars outbreak as it was in rural africa with the most recent ebola outbreak. yet, each geographical166 territory may offer unique challenges and/or considerations when it comes to the outbreak and control of infectious diseases. in hong kong, for example, the remains of the deceased who had died from a particularly infectious disease and whose remains may still pose some risk upon exhumation can, under certain circumstances, prove pivotal. sylvanus spencer therefore warns that the mere “translation” of biomedical and legal measures into local idioms to effect behavioural change in efforts to control disease outbreaks may not be enough. he submits that a full understanding of “the heterogeneity of social factors and the multiplicity of actors inserting agency in the translation” of intervention measures is ultimately necessary. noteworthy in this regard is that the interdependent self-concepts167 so characteristic of traditional african (and also asian) cultures may have contributed to the relative success of bylaws in effecting behavioural change in the context of the recent ebola outbreak. yet, such an interdependent self-concept that emphasises group goals and the appreciation of communalities with others, stands in stark contrast to the independent self-concepts usually associated with western cultures which places more emphasis on personal goals and recognition of one’s differences from other people. thus, whether the enforcement of state168 emergency regulations as well as the enactment and abidance of more informal regulatory measures by local authoritative figures would be equally effective in effecting behavioural change in the face of a public health emergency in a typical western cultural context, is indeed questionable. v. to quarantine or not to quarantine: a legal or public health question? the first known incidence of a medical quarantine—in terms of which people 165. see wilson, supra note 163, at 116. 166. see generally nielsen et al., supra note 160. 167. sylvanus n. spencer, “invisible enemy”: translating ebola prevention and control measures in sierra leone 2 (dfg priority programme, working paper no. 13 2015), http://www.spp1448.de/fileadmin/media/galleries/spp_administration/working_paper_series/ spp1448_wp13_spencer_upd.pdf [https://perma.cc/3phc-k2qm]. 168. cecilia cheng & aik-kwang ng, psychosocial factors predicting sars-preventive behaviours in four major sars-effected regions, 36 j. applied psychol. 222, 225 (2006). 272 indiana health law review [vol. 15:247 or goods were restrained in their movement because of the risk of contagious disease—was in 539 a.d., when the byzantine emperor justinian enacted a law to isolate individuals coming from plague-infested regions from entering his lands. this mandatory separation of persons, animals, or goods that may have169 been exposed to contagious disease has been the cornerstone of coordinated disease-control strategies since the fourteenth century, during the plague epidemic of 1347-1352. in fact, the word “quarantine” is derived from the italian term170 “quaranta” which means forty; the number of days which ships, during the black death plague epidemic of the seventeenth century had to stay at sea before passengers could disembark. since the late nineteenth century, many have171 believed that the battle against infectious diseases has largely been won in light of medical advances and the availability of vaccines and antibiotics. quarantine172 is therefore often described as “a relic of the past, useless, and damaging to commerce.” however, to date, the centuries-old strategy of quarantine remains173 an important component of the public health response to emerging and reemerging infectious diseases, as well as potential acts of biological terrorism.174 175 the siracusa principles make specific provision, for example, for the limitation of rights in situations of public emergency, and particularly on grounds of public health “in order to allow a state to take measures dealing with a serious threat to the health of the population or individual members of the population. these measures must be specifically aimed at preventing disease or injury or providing care for the sick and injured.” the political, economic, social, and ethical176 169. vidya eswaran, quarantine: ethical and legal battle for human rights during public health emergencies, emergency pub. health (oct. 31, 2014), http://emergencypublichealth.net/ 2014/10/31/quarantine/ [https://perma.cc/gv2t-z62f]. for a brief history of quarantine, see rothstein, supra note 153. 170. tognotti, supra note 83, at 254. 171. it is unclear why the quarantine period was set for forty days exactly. see m.d. grmek, the concept of infection in antiquity and the middle ages, the old social measures against contagious diseases and the foundation of the first quarantine in dubrovnik (1377f) [in french], 348 rad jugoslavenske akademije 9-55 (1980); dorothy porter, health, civilization and the state: a history of public health from ancient to modern times (london: routledge 1999); cipolla, supra note 98. 172. ursula schlipköter & antoine flahault, communicable diseases: achievements and challenges for public health, 32:1 pub. health revs. 90-119 (2010). 173. tognotti, supra note 83, at 256. 174. an example of a re-emerging infectious disease is tuberculosis. see david m. morens et al., the challenge of emerging and re-emerging infectious diseases, 430 nature 242, 245 (2004). 175. tognotti, supra note 83, at 254. 176. comm. on human rights, u.n. siracusa principles on the limitation and derogation provisions in the international covenant on civil and political rights, e/cn.4/1985/4, at 4 (sept. 28, 1984). it is also emphasized in the siracusa principles that where rights are limited on the ground of public health, that that due regard also be had to the international health regulations of the who. 2018] international and operational responses to disease control 273 concerns that have been raised with regard to quarantine in terms of the ebola and sars epidemics will briefly be considered here, for as far as it is relevant to the argument presented in this article. the cdc defines quarantine as the separation of an individual or group reasonably believed to have been exposed to a quarantinable communicable disease but who is not yet ill (not presenting signs or symptoms), from others177 who have not been so exposed, in order to prevent the possible spread of the quarantinable communicable disease. isolation, on the other hand, refers to the178 separation of an individual or group who is reasonably believed to already be infected with a quarantinable communicable disease from those who are not infected, in order to prevent the spread of the particular disease. while both179 quarantine and isolation have at aim to prevent the spread of a quarantinable communicable disease, quarantine applies to individuals or groups who are reasonably believed to have been exposed to a quarantinable communicable disease, and isolation applies to individuals or groups who are reasonably believed to have already been infected with such a disease. controlled movement, in contrast, only limits the movement of people, animals or goods with regard to long distance commercial conveyances (e.g. aircraft, ship, bus or train) and/or other public transportation (e.g. bus or subway).180 with the most recent ebola outbreak, the governments of guinea, liberia and sierra leone imposed quarantines on individual houses, neighbourhoods, villages and even entire administrative districts. on 30 july 2014, liberian president181 johnson sirleaf announced several emergency measures, including quarantines, and ultimately declared a state of emergency on 6 august 2014, citing the need “for extraordinary measures for the very survival of our state.” liberian182 177. in the u.s., the following communicable diseases are subject to federal authorization for isolation and quarantine: cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndromes, and flu that can cause a pandemic. see legal authorities for isolation and quarantine, ctrs. for disease control & prevention (oct. 8, 2014), http://www.cdc.gov/quarantine/aboutlawsregulationsquarantine isolation.html [https://perma.cc/8hew-yfm4]. 178. interim u.s. guidance for monitoring and movement of persons with potential ebola virus exposure, ctrs. for disease control & prevention 3 (nov. 3, 2014), https://www.mainequalitycounts.org/image_upload/interim_guidance_cdc_10-27-14.pdf [https://perma.cc/fp2y-2akf] [hereinafter cdc]. 179. id.; see also gene w. matthews et al., legal authorities for interventions in public health emergencies, in law in public health practice 272 (richard a. goodman et al. eds., 2d ed. 2007). 180. cdc, supra note 178; see also martin cetron & julius landwirth, public health and ethical considerations in planning for quarantine, 78 yale j. biology & med. 325 (2005). 181. west africa: respect rights in ebola response, human rights watch (sept. 15, 2014), ht tp: / /www.hrw.org/news/2014/09/15/west-africa-respect-r ights-ebola-response [https://perma.cc/gf8b-3ek4]. 182. id. 274 indiana health law review [vol. 15:247 security forces were tasked to enforce these security measures. on 20 august183 2014, curfews were extended and the west point slums in monrovia were completely sealed off, leading to violent clashes between security forces and residents of the west point areas. live ammunition was used and dozens were184 injured and one killed. on 30 july 2014 and again on 7 august 2014, president185 koroma from sierra leone announced a state of emergency in terms of section 29(5) of the constitution (1991) and ordered quarantines at all the epicenters of the disease. these quarantines were to be enforced by police and the military.186 187 other measures included the restriction of public meetings and gatherings not related to ebola sensitization and surveillance and house-to-house searches to trace and quarantine ebola victims. this was followed by a three-day shut188 down on 19 september 2014, during which time pedestrians and vehicles were barred from the country’s streets and authorities searched for any ebola cases or deceased. they ultimately discovered 100 bodies and 200 patients, but various humanitarian actors questioned the methods used by security forces to enforce the quarantines. by 25 september 2014, an estimated third of the country’s189 population was under quarantine and, with over one million people in quarantine, food shortages due to lack of labour, trade and commodities continued to escalate throughout december 2014. on 13 august, president condé from guinea also190 declared a public health emergency under the public health code law 97 of 19 june 1997 and established quarantine areas enforced by health workers and security forces. in light of this, neighbouring african countries like cote191 d’ivoire and senegal also imposed restrictions on the movement of people and goods, including border closures during this time.192 the impact of these quarantines in west africa has been extensive. quarantine measures do not only restrict people’s rights to liberty and freedom of movement, but also impact on their livelihood, contributing to food insecurity, 183. id. 184. the assessment capacities project, ebola outbreak in west africa: lessons learned from quarantine–sierra leone and liberia 5 (mar. 19, 2015) [hereinafter acaps]. 185. id. ibrahim al-bakri nyei, beyond the disease: how the ebola epidemic affected the politics and stability of the mano river basin, accord–african centre for the constitutive resolution of disputes (aug. 16, 2016), http://www.accord.org.za/conflict-trends/beyond-thedisease/ [https://perma.cc/at53-5r7k] (last visited 29 march 2018). 186. human rights watch, supra note 181. 187. id. 188. id. 189. acaps, supra note 184, at 1. 190. id.; see also rothstein, supra note 159, at 252-54. 191. human rights watch, supra note 181. 192. amadou sy & amy copley, africa in focus: understanding the economic effects of the 2014 ebola outbreak in west africa, brookings (oct. 1, 2014), http://www.brookings.edu/blogs/ africa-in-focus/posts/2014/10/01-ebola-outbreak-west-africa-sy-copley [https://perma.cc/3qa9wv3y]. 2018] international and operational responses to disease control 275 loss of employment, and access to health care. an oxfam protection assessment193 involving 800 respondents, including community and religious leaders, also indicated that quarantine measures contributed greatly to the stigma and shame of the disease. and, most of these quarantine strategies were not based on194 scientific evidence, but were arbitrarily applied, and overly broad in implementation. the quarantines were not adequately monitored, “making195 them ineffective from a public health perspective and disproportionately impacting people unable to evade the restrictions, including the elderly, the poor, and people with chronic illness or disability.” while it is evident from the196 exposition in part ii of this article, that the isolation of those infected with a quarantinable communicable disease like ebola is pivotal to the public health strategy in curing the spread of contagion, the question about the legality of certain quarantine measures has raised concern and came under specific scrutiny when panic about a possible global spread of ebola took hold. on 8 october 2014, thomas eric duncan, a liberian visitor to the u.s., died from ebola in a dallas hospital. when it later became known that he had197 infected two of the nurses who had cared for him, anxiety about the possible global spread of the west african ebola ensued. a mere two weeks later, craig198 spencer, a medical doctor who had worked with doctors without borders in guinea, was taken to the new york bellevue hospital centre after reporting fever. he tested positive for the virus shortly after. the panic of “a virus on199 200 193. human rights watch, supra note 181. 194. acaps, supra note 184. 195. human rights watch, supra note 181. 196. acaps, supra note 184. 197. greg botelho & jacque wilson, thomas eric duncan: first ebola death in u.s., cnn (oct. 8, 2014, 3:19 pm est), https://www.cnn.com/2014/10/08/health/thomas-eric-duncanebola/index.html [https://perma.cc/fu3f-6hw9]. 198. today, it is generally accepted that the dallas hospital was completely unprepared for dealing with an ebola infection and that the necessary precautionary measures had not been in place, nor were staff issued with adequate protective garb; both nurses survived the infection. see doyle mcmanus, america’s epidemic of fear over ebola, l.a. times (oct. 28, 2014), http://www.latimes.com/opinion/op-ed/la-oe-mcmanus-column-ebola-poltics-20141029column.html [https://perma.cc/6gz9-vkyy]; chico harlan, an epidemic of fear and anxiety hits americans amid ebola outbreak, wash. post (oct. 15, 2014), https://www.washingtonpost. com/business/economy/an-epidemic-of-fear-and-anxiety-hits-americans-amid-ebolaoutbreak/2014/10/15/0760fb96-54a8-11e4-ba4b-f6333e2c0453_story.html?utm_term=. 985efc807b80 [https://perma.cc/z4nz-w8uv]. 199. jonathan cohn, the first case of ebola has been diagnosed in new york. here’s what we know., the new republic (oct. 23, 2014), https://newrepublic.com/article/119971/ebola-newyork-city-craig-spencer-doctor-bowled-and-took-subway [https://perma.cc/e42l-g969]. 200. id. dr. craig spencer also survived evd. see anemona hartocollis, doctor who survived ebola says he was unfairly cast as a hazard and a hero, n.y. times (feb. 25, 2015), https://www.nytimes.com/2015/02/26/nyregion/craig-spencer-new-york-ebola-doctor-speaks276 indiana health law review [vol. 15:247 the loose” spread through new york as it became known that spencer, before reporting to the hospital, had traveled around new york city, went dining, took subways and even went bowling. the governors of three states—chris christie201 of new jersey, andrew cuomo of new york, and paul lepage of maine —fed202 this panic by unveiling a mandatory twenty-one day quarantine—the incubation period of the disease—for any person (including health workers) entering the said states and who may have had contact with ebola sufferers in west africa. this203 policy went far beyond the federal rules set out by the cdc, which required that public health authorities conduct active post-arrival monitoring of travelers204 from liberia, sierra leone, or guinea who arrived at one of the five airports in the u.s. a number of people were subsequently placed under quarantine in205 different parts of the u.s. in terms of these policies. in dallas, for example, the close contacts of thomas eric duncan were placed under quarantine and so were out.html [https://perma.cc/p826-mpjy]. 201. mary harris & tracie hunte, ebola doc craig spencer speaks out, wnyc (jan. 29, 2015), http://www.wnyc.org/story/ebola-doc-speaks-out/ [https://perma.cc/d9cp-av32]. 202. the governors of illinois, ohio, and georgia followed suit while other states like florida, maryland and virginia only required that persons returning from west african countries be monitored depending on their level of risk. see dominic rushe, isolated nurse slams chris christie’s ebola quarantine policy, the guardian (oct. 26, 2014), https://www.theguardian. com/world/2014/oct/26/ebola-christie-quarantine-west-africa-monitor-symptoms-airport [https://perma.cc/r7g9-5e45]; matt flegenheimer, michael d. shear & michael barbaro, under pressure, cuomo says ebola quarantines can be spent at home, n.y. times (oct. 26, 2014), https://www.nytimes.com/2014/10/27/nyregion/ebola-quarantine.html [https://perma.cc/7kpw7ggu]; gail sullivan & abby ohlheiser, maine gov. paul lepage is seeking legal authority to enforce ebola quarantine on nurse, wash. post (oct. 29, 2014), https://www.washingtonpost.com/ news/morning-mix/wp/2014/10/29/after-fight-with-chris-christie-nurse-kaci-hickox-defies-ebolaquarantine-in-maine/?utm_term=.ee77cb99692a [https://perma.cc/n9js-9tsr]; see also mcmanus, supra note 191. 203. the dangers of quarantines: ebola policies made in panic cause more damage, n.y. times (oct. 27, 2014), http://www.nytimes.com/2014/10/28/opinion/ebola-policies-made-in-paniccause-more-damage.html?_r=0 [https://perma.cc/9uwh-ku23] [hereinafter n.y. times] (noting that the mandatory twenty-one day quarantine was announced by the governors on 24 october 2014). 204. cdc, supra note 178 (explaining that active monitoring places an obligation on the state or local public health authority to establish regular contact with potentially exposed individuals, including checking daily to assess for the presence of symptoms, including fever, rather than relying solely on the individuals to self-monitor and report on their symptoms). 205. cetron & landwirth, supra note 180, at 327 (noting that the responsibility for public health matters in the u.s. rests on both the federal and state governments. relevant state laws, regulations and procedures vary widely and the model state emergency health powers act is described by cetron and landwirth as an attempt to promote greater inter-state consistency in response to emergency public health situations. federal powers for quarantine is delegated to the cdc who is empowered to make quarantine regulations in terms of § 361 of the public health service act, usc title 42, chapter 6a, part g). 2018] international and operational responses to disease control 277 three individuals in new york who had close contact with dr. spencer.206 similarly, kaci hickox, a nurse returning from sierra leone where she had worked for doctors without borders, was detained at the newark liberty international airport and placed under strict quarantine in an isolation unit at the university hospital in newark. these state-specific quarantine measures came207 under a barrage of criticism from public health experts who argued that there was no public health justification for such mandatory quarantines. it was submitted208 that the transmission of evd requires “bodily fluid or blood contact, mandatory quarantine of asymptomatic healthcare workers who are expected to comply with active health monitoring by public health authorities provides no substantial benefit and little, if any, theoretical benefit.” it was also argued that such an209 overreaction may further stigmatize the disease and those infected with it, instill fear in the public, encourage people to hide their travel history, and discourage health workers from volunteering to fight ebola in africa. 210 the stringent requirements with regard to the twenty-one-day mandatory quarantine period was eventually relaxed, instead requiring that people returning from west africa be confined to their own homes for twenty-one days (the incubation period of the virus) and that they be checked twice daily by public 206. jill moore, ebola and the law of isolation and quarantine in north carolina, coates’ canons: nc local gov’t l. (oct. 31, 2014), http://canons.sog.unc.edu/?p=7898 [https://perma. cc/397m-vdxa]. 207. dominic rushe, isolated nurse slams chris christie’s ebola quarantine policy, the guardian (oct. 26, 2014), https://www.theguardian.com/world/2014/oct/26/ebola-christiequarantine-west-africa-monitor-symptoms-airport [https://perma.cc/73sh-kgq3]. 208. robert lowes, experts oppose quarantine for returning ebola care workers, medcape medical news (oct. 27, 2014), https://www.medscape.com/viewarticle/833919 [https://perma.cc/9e7w-xwt4]; ellen wulfhorst & david morgan, cdc says returning ebola medical workers should not be quarantined, reuters (oct. 28, 2014), https://www.reuters.com/ article/us-health-ebola-usa-newyork/cdc-says-returning-ebola-medical-workers-should-not-bequarantined-iduskbn0ig12920141028 [https://perma.cc8v39-ywl6]; see also council on ethical and judicial affairs, report of the ceja 1-i-05: the use of quarantine and isolation in public health intervention, pub. heath rep. (nov. 2005), http://www.amaassn.org/ama/pub/about-ama/our-people/ama-councils/council-ethical-judicial-affairs/cejareports.page [https://perma.cc/8kq7-gm77] (noting the 2005 recommendations by the council on ethical and judicial affairs of the american medical association recognizing the tensions between quarantine and isolation as measures to protect public health and the individual rights to liberty and self-determination. in terms of these recommendations quarantine and isolation will only be ethically justified if based on sound scientific considerations). 209. kenneth j. o’dowd, ebola: quarantines may complicate job of u.s. public health officials, the herald (dec. 16, 2014), http://ahherald.com/letters/19027-ebola-quarantines-maycomplicate-job-of-u-s-public-health-officials [https://perma.cc/6x4y-m4ax]. 210. john dean, travel bans and mandatory quarantines: ebola panic calls for clarifying the law, verdict (oct. 31, 2014), https://verdict.justia.com/2014/10/31/travel-bans-mandatoryquarantines [https://perma.cc/c34j-fr9a]; wulfhorst & morgan, supra note 208. 278 indiana health law review [vol. 15:247 health officials for any symptoms. in light of this, hickox was transported to211 her home in maine after having spent three days in an isolation tent. hickox, however, continued to publicly defy the state imposed quarantine period. the212 state went to court but chief district court judge charles c. la verdiere found that “[maine] has not met its burden at this time to prove by clear and convincing evidence that limiting [hickox’s] movements to the degree requested is necessary to protect other individuals from the dangers of infection. [hickox] currently does not show any symptoms of ebola and is therefore not infectious.” hickox never213 showed any symptoms of ebola and it was reported that she intends on “suing christie and other state officials for $250,000, alleging false imprisonment, invasion of privacy and violation of due process, among other claims.” it was214 the escalation of these events that ultimately led to the cdc issuing their revised interim u.s. guidance for monitoring and movement of persons with ebola virus exposure, as well as additional guidelines recommending how people with direct exposure to ebola patients or burials should be dealt with, to avoid further confusion of state-by-state policies. these federal monitoring rules require215 state and local health departments to contact travelers returning from the ebolastricken countries in west africa on a daily basis for twenty-one consecutive days and to check for any symptoms including a high fever. 216 217 the above narrative on the unfolding of quarantine measures in the “groundzero” african countries where the ebola outbreak started, as well as in the u.s. where isolated incidences of infection were recorded, reveals a tale of swift and severe action by state officials in imposing quarantine measures driven by fear and panic, and not necessarily based on sound scientific and medical evidence. again, keeping in mind that different infectious diseases and geographical 211. n.y. times, supra note 203. 212. jessica glenza, kaci hickox defies ‘excessive’ ebola quarantine by taking a bike ride, the guardian (oct. 30, 2014), https://www.theguardian.com/world/2014/oct/30/maine-nursedefies-ebola-quarantine-bike-ride [https://perma.cc/eal8-a25s]. 213. jessica glenza, victory for maine nurse as judge makes u-turn on ebola monitoring order, the guardian (oct. 31, 2014), https://www.theguardian.com/us-news/2014/oct/31/mainenurse-ebola-guidelines-judge-lifts-order [https://perma.cc/3tfa-cncu]. 214. justin wm. moyer, kaci hickox, rebel ebola nurse loathed by conservatives, sues chris christie over quarantine, wash. post (oct. 23, 2015), https://www.washingtonpost.com/ news/morning-mix/wp/2015/10/23/kaci-hickox-rebel-ebola-nurse-loathed-by-conservatives-sueschris-christie-over-quarantine/?utm_term=.64ba697eb546 [https://perma.cc/e3al-cqla]. 215. cdc, supra note 178 (noting that the new monitoring system came into effect on monday 27 october in six states—new york, pennsylvania, maryland, virginia, new jersey and georgia—and was eventually expanded across the country); see also n.y. times, supra note 203 (noting the additional guidelines provided, for example, that a person at a high risk of ebola be strongly advised “and if necessary, even ordered by health authorities . . . to avoid traveling or congregating in public”). 216. n.y. times, supra note 203 (noting twenty-one days is the maximum period for symptoms to develop). 217. id. 2018] international and operational responses to disease control 279 locations may call for different measures, interesting similarities and comparisons can be observed when revisiting the quarantine narratives of the three countries hardest hit by the 2003 sars outbreak. as indicated in part ii of this article, the sars outbreak of 2003 was unexpected and swift in its onset, spread and duration. a marked difference between the ebola outbreak and the sars218 outbreak that is important to repeat here is that much scientific information and literature was already available with the ebola outbreak of 2013, while very little was known about sars when various incidences of infection was reported in quick succession across the globe in 2003. a review of newspaper and other219 reports on the sars outbreak therefore reveals a series of isolation and quarantine actions and recommendations issued by various governments and other role-players. the most important of these measures and recommendations220 will briefly be relayed here. on 14 march 2003, only two days after the who issued a global alert about sars, an infection was reported in toronto, which prompted the who in issuing an emergency travel advisory warning that the new disease was spreading worldwide and asking travelers to be wary of sars symptoms and to report to airport personnel if they or fellow passengers showed any signs of the disease.221 by the end of march 2003, however, “panic and quarantines on a global level” became the legacy of sars. on 23 march, scarborough grace hospital in222 toronto closed temporarily due to an outbreak of sars, and on 26 march a public health emergency was declared in ontario, canada, with “[t]housands of people…ordered into self-quarantine and told not to leave their homes.” after223 a small number of passengers on international flights contracted sars from fellow passengers, the who escalated its initial emergency travel advisory by requesting canada, hong kong, and singapore to screen passengers with sars symptoms. and on the first of april, american airlines flight 128 from tokyo224 was briefly quarantined on the tarmac of san jose international airport in california after five passengers reported sars-like symptoms. with other225 isolated incidences of infection reported in australia, indonesia, malaysia and 218. see supra part ii. 219. yu, supra note 70. 220. for a discussion of some of these isolation and quarantine actions, see david m. bell & who working group on prevention of international and community transmission of sars, public health interventions and sars spread, 2003, 10:11 emerging infectious diseases 190006 (2004); richard schabas, severe acute respiratory syndrome: did quarantine help?, 15:4 can j. infect. dis. med. microbiol. 240 (2004); ying-hen hsieh et al., impact of quarantine on the 2003 sars outbreak: a retrospective modeling study, 224(4) j. theoretical biology 1729-36 (2007). 221. lee, supra note 22, at 14. 222. id. at 15. 223. id. 224. id. at 15-16. 225. id. at 16. 280 indiana health law review [vol. 15:247 singapore, the who declared another travel advisory on 2 april, “asking potential passengers to ‘consider postponing all but essential travel’ to hong kong and guangdong province.” this travel advisory was echoed by the cdc,226 who also added singapore and hanoi to the list of countries. 227 in addition to these travel advisories, quarantine and isolation measures on the ground also progressed rapidly. on 31 march 2003, the hong kong health department issued an isolation order requiring “all residents of an entire apartment block into self-quarantine until april 9.” a day later, however, after228 having found the initial quarantine to be ineffective, all the residents of the apartment block were relocated to an isolation camp. unfortunately, due to the229 secrecy with which the chinese government approached their handling of the sars outbreak, very little is known about quarantine and isolation measures on the chinese mainland. however, reports exist indicating that 10,000 people were quarantined in the eastern chinese city of nanjing, and that more than 15,000 people were quarantined in beijing, where the city’s eighty water reservoirs were sealed off from the public in an effort to prevent the virus from entering the city’s water supply. entertainment venues and schools were closed and recreational230 activities halted in the capitol city of beijing. in toronto, the only city outside231 asia to eventually be included under the who travel advisory (23 april 2003), approximately 7,000 people were quarantined. noteworthy about the canadian quarantine measures, however, is that people who may have been exposed to sars were asked to voluntarily quarantine themselves. and in taiwan,232 131,132 people were placed under home quarantine, of which only twelve were found to be potential cases of sars, and only two were confirmed to have sars. similar to the effects that quarantine and isolation measures had in233 africa with the ebola outbreak, economic losses were also reported worldwide as a result of the measures imposed during the sars outbreak. for example, on 9 april 2003, australia’s qantas airlines cut approximately 3% of its workforce in the wake of the sars outbreak, and various other airlines also reported financial losses as a result of cuts in flights. hong kong’s economy “sputtered234 miserably in the wake of sars” and damning reports by experts like james hughes of the national center for infectious diseases in atlanta, georgia, did not 226. id. at 17. 227. id. 228. id. at 15-16. 229. id. at 17. 230. id. at 25; see also thousands quarantined as sars riots hit china, abc news (may 6, 2003, 3:46 pm), http://www.abc.net.au/news/2003-05-06/thousands-quarantined-as-sars-riots-hitchina/1849078 [https://perma.cc/73r7-d5m7] [hereinafter abc news]. 231. lee, supra note 22 at 25; abc news, supra note 230. 232. lee, supra note 22, at 21; mandatory ebola quarantine is about politics, not public health, the conversation (oct. 28, 2014, 3:07 pm), http://theconversation.com/mandatory-ebolaquarantine-is-about-politics-not-public-health-33531 [https://perma.cc/ff8y-2gt5]. 233. rothstein, supra note 159, at 252. 234. lee, supra note 22, at 18. 2018] international and operational responses to disease control 281 help the situation. hughes was quoted in a newspaper article saying that “[i]t235 would be hard for me to see how [sars] could be eliminated from places like…hong kong at this point…i think it would be prudent to say it’s here to stay.” and in canada, the who travel warning issued on 23 april 2003 had236 an almost immediate effect with store owners reporting “business falling by half overnight, and traffic in shopping malls ground[ing] to a near halt.” 237 another similarity between the quarantine measures of the ebola and sars outbreaks relate to the use of force in effecting the separation and confinement of persons in an effort to control the spread of the disease. in beijing, it was reported that the police cordoned off buildings, organized checkpoints on roads, and even installed web-cameras in private homes. stronger control was238 furthermore exerted over persons in the lower social strata, with village-level governments being empowered, for example, to isolate workers from sarsaffected areas. repressive police-type measures by public health officials were also reported in some areas, and laws were promulgated prescribing “extremely severe punishments (including the death penalty), against those who violated quarantine.” people, in turn, reacted forcefully to these violent measures239 imposed in the name of “public health” and it was reported that in remote areas of china, residents destroyed quarantine centres and attacked government officials. 240 similar incidences of violence were also reported during the recent ebola outbreak, during which the use of military force in effecting quarantines seemed to be prevalent. in monrovia, liberia, fear and resentment after the government placed an entire neighbourhood under strict quarantine, together with general social and political tensions, created an explosive atmosphere that culminated in populist rebellions and uprisings. this ultimately led to the death of a fifteen-241 year-old boy, who was shot, and four other residents wounded, when angry residents clashed with security forces. the appropriateness of using such242 security forces in maintaining quarantines in liberia and sierra leone was questioned when allegations came to the fore that many security officers had been 235. id. 236. rob stein, sars virus seen as long-term threat, wash. post (apr. 21, 2003), https://www.washingtonpost.com/archive/politics/2003/04/21/sars-virus-seen-as-long-termthreat/ab79e918-c782-4994-94f3-9d8370c8b6fc/ [https://perma.cc/tlf9-jczf] (internal quotation marks omitted). 237. lee, supra note 22, at 21. 238. id. at 29; tognotti, supra note 83, at 258. 239. tognotti, supra note 83, at 258. 240. abc news, supra note 230. 241. norimitsu onishi, clashes erupt as liberia sets an ebola quarantine, n.y. times (aug. 20, 2014), http://www.nytimes.com/2014/08/21/world/africa/ebola-outbreak-liberia-quarantine. html?_r=1 [https://perma.cc/wf27-evlq]. 242. human rights watch, supra note 181. 282 indiana health law review [vol. 15:247 accepting bribes from people wanting to leave the quarantined areas. the243 militarization of ebola in western africa reminded some generations of the relatively recent civil war, and yet others of colonial coercion in the name of promoting hygiene. the military presence during the ebola outbreak thus created a heightened sense of uncertainty and distrust, and the need for vigilance (and self-preservation) in communities.244 the appropriateness and effectiveness of quarantine as a public health strategy in curbing the spread of infectious diseases has long been contested: first during the yellow fever outbreak of the eighteenth century, when french revolutionary ideals fostered an affirmation for citizen’s rights and personal freedom, and later by way of the discerning voices of mid-nineteenth century scientists dismissing quarantine as irrelevant in the prevention of cholera.245 quarantine restrains personal liberty, is a method of temporary detention, is an inconvenience, and can be potentially dangerous when healthy-but-suspected disease carriers are quarantined together with the sick. quarantine strategies are often accompanied by an undercurrent of suspicion, distrust, and sometimes also result in riots and other forms of violence, as was evident from the ebola and sars examples referred to above. finally, it must also be noted that,246 unfortunately, quarantine measures have also been abused by governments. for example, in the u.s. in the 1900s, after a court struck down the mandatory order for the inoculation of all chinese americans with an experimental vaccine prior to leaving the city, chinese residents in san francisco were quarantined during an outbreak of the bubonic plague. in 1991, hiv-positive haitian refugees247 were quarantined in guantanamo bay, despite it then already being known that hiv/aids is not casually transmitted. and shortly thereafter, when an248 epidemic of multi-drug resistant tuberculosis (“tb”) emerged in new york and other parts of the u.s., hundreds of so-called non-compliant tb patients were quarantined. such examples of quarantine abuse usually target the most249 vulnerable: the homeless, immigrants, and those who suffer from mental illness and substance abuse.250 243. id. 244. spencer, supra note 167, at 13. 245. tognotti, supra note 83, at 255. 246. id. at 258. 247. wendy e. parmet, quarantines are a blunt instrument in the fight against ebola, brink (nov. 12, 2014), http://www.brinknews.com/quarantines-are-a-blunt-instrument-in-the-fightagainst-ebola/ [https://perma.cc/xt64-qujr]. 248. id. 249. id. 250. see monica schoch-spana et al., stigma, health disparities, and the 2009 h1n1 influenza pandemic: how to protect latino farmworkers in future health emergencies, 8 biosecurity bioterrorism 243, 243-54 (2010) (explaining how minority groups like jews and persons with leprosy were already discriminated against in terms of quarantine policies as early as 1347–1352 with the plague epidemic, when such individuals were denied entry to cities and ports. and in 1836 with the cholera outbreak in naples, prostitutes and beggars were denied free 2018] international and operational responses to disease control 283 michael willrich describes quarantine as “an uncommon public health technology” and as unnecessary and ineffective, particularly when applied on a large scale. quarantine, according to willrich, is also as “an incredibly blunt251 instrument…too easily politicized.” and sophie delaunay, executive director252 of msf-usa médecins sans frontières, in denouncing the recent ebola quarantines in the u.s. stated that “[t]here are other ways to adequately address both public anxiety and health imperatives, and the response to ebola must not be guided primarily by panic in countries not overly affected by the epidemic.”253 yet, fear and panic are the main drivers behind modern day quarantine measures. it is the false sense of security that quarantine inspires and makes governments so reluctant to “abandon the protection of the traditional strategies that provided an antidote to population panic.” because “when a deadly new disease strikes,254 people expect their leaders to take bold and decisive action ‘out of an abundance of caution.’” this caution relates to risk, and risk, according to lawrence255 gostin, is a function of two things: probability that harm will occur and the severity of that harm, should it transpire. gostin further explains that these two256 factors have a roughly inverse relationship: “the more severe the potential harm, the less the probability, or risk, we are willing to assume.” yet, people are not257 always rational actors and people do not always assess reasonably the risk that they pose to others, or the risk that they may subject themselves to in certain situations or under certain circumstances. 258 related to this notion of risk and how “rational” people are expected to act, it must also be noted, as it was in the previous section of this part with regard to the effectiveness of bylaws in bringing about behavioural change, that cultural factors may also play a role. noel brewer from the university of north carolina’s gillings school of global public health, in juxtaposing western american values with that of asian cultures, articulates it as follows: part of the problem is cultural…americans tend to think more about individual than communal rights and are understandably dubious of medical mandates that seem to be always changing. americans also value movement by health officials.); tognotti, supra note 83, at 256. 251. julian cardillo, learning from past epidemics: what can smallpox tell us about ebola? brandeisnow (dec. 2, 2014), http://www.brandeis.edu/now/2014/december/willrich-ebolaqanda.html [https://perma.cc/e5ra-xqrx]. 252. id. 253. eswaran, supra note 169. 254. tognotti, supra note 83, at 256. 255. parmet, supra note 247. 256. n.y. times, ebola outbreak raises ethical issues about spreading disease, sf gate, http://www.sfgate.com/health/article/ebola-outbreak-raises-ethical-issues-about-5884540.php [perma.cc/zv5x-t3gy] (last updated nov. 11, 2014). 257. id. 258. id. 284 indiana health law review [vol. 15:247 toughness and the ability to work through physical adversity without thinking how they might end up weakening other members of a team. contrast this with many asian countries where it’s common to see people wearing surgical masks in public. tellingly, americans tend to assume this is to prevent the mask wearer from getting sick. but it’s actually more often the reverse: the wearer is sick and the mask serves not only to prevent passing germs to others but also to alert people that the wearer is unwell and they should keep their distance.259 thus, to conclude this part on the national legal responses to the public health emergencies posed by the ebola and sars outbreaks, the obvious—which is often forgotten in moments of health panic—needs to be restated: quarantine can undoubtedly—in the absence of effective pharmaceutical interventions, and only if it is the least restrictive means available/necessary to protect public health—serve as an acceptable public health measure to contain infection, to delay the spread of disease, to avert terror and death, and to maintain the infrastructure of society. unfortunately, however, too many examples exist of260 how quarantine strategies have been misused and abused. as a rule of thumb, quarantine strategies may be warranted and effective when it is based on sound scientific and medical information, is the result of a rational decision-making process that takes into consideration the particularities of the specific circumstances and disease, and is implemented and enforced in a manner that promotes trust and certainty, rather than cultivating fear, panic and suspicion. in other words, the restriction on the freedom and liberty of persons in the name of public health or a public emergency must meet the requirements of “legality, evidence-based necessity, and proportionality.” the illusion that safety can be261 assured by keeping those who are dangerous away should be heeded against at all cost, and the duty is ultimately on the state to show that there is no less onerous way to reduce the risk of contagion. 262 vi. lessons to be learnt: why knowledge production beyond disciplinary confines is necessary a. failings of international legal frameworks for and responses to disease control given the history and background of the existing international legal framework for disease control and public health emergencies, two major shortcomings can be identified: the first relates to the ihr (2005) obligations 259. id. 260. see cetron & landwirth, supra note 180, at 325 (providing an exposition of the ethical requirements that must be considered for quarantine to be ethically justified); tognotti, supra note 83, at 258; human rights watch, supra note 181; rothstein, supra note 159, at 231. 261. human rights watch, supra note 181; see also rothstein, supra note 159, at 249-73. 262. human rights watch, supra note 181; rothstein, supra note 159, at 249-73; parmet, supra note 247. 2018] international and operational responses to disease control 285 placed on member states to take a number of measures to prevent, to respond to, and to control the spread of disease and to implement appropriate measures within its domestic legal and public health systems. with the most recent outbreak of ebola, it was now more clear than ever that member states are largely failing to meet these obligations in this regard. for example, the who’s 2012 report on ihr core capacity implementation revealed that only 19% of its signatory states on the african continent have implemented the ihr requirements in their national legal and public health systems. a joint report by the world263 bank, african development bank and european union specifically focusing on the most recent ebola outbreak highlighted the poor pre-ebola implementation of these regulations, noting that “systems for early warning and response were inadequate, lacked necessary accountability and links with or support from national disaster management mechanisms and were not prepared to scale up response to this kind and scale of epidemic.” 264 a second shortcoming, largely stemming from this failure of member states to ensure that the core capacities or minimum set of standards for public health surveillance and response as set out in the ihr (2005) are incorporated in national legal and health systems, is that much of the other international responses to disease control that are dependent on the existence and efficiency of an appropriate national framework also fail. for example, as with the h1n1 influenza outbreak in 2009 and the spread of poliomyelitis in may 2014, the director-general declared the most recent outbreak of ebola to be a pheic in terms of the ihr (2005) and issued temporary recommendations to affected countries. yet, as with the previous two declarations of pheics, the265 compliance of who member states with the director-general’s temporary recommendations has been uneven, especially with regard to the recommendations to avoid generalized border closures and the suspension of commercial flights. and, despite a who review committee calling for266 international collaboration to form an “extensive global public health reserve workforce to counter crises and outbreaks of disease” in the aftermath of the swine flu epidemic of 2010, the world has yet to respond to these recommendations, recommendations that could have made a real difference in the outcome of the recent ebola outbreak had they been in place. 267 263. world health org., summary of 2011 states parties report on ihr core capacity implementation 50 (2012), http://www.who.int/ihr/publications/who_hse_ gcr_2012.10eng/en/ [https://perma.cc/tmz7-kh4y]. 264. united nations dev. programme, recovering from the ebola crisis 44 (lance w. garmer ed., 2015). 265. burci & quirin, supra note 6. 266. id. 267. john lauerman, simeon bennett & makiko kitamura, ebola spread after who’s 2010 warning ignored, agency says, bloomberg (jan. 15, 2015, 1:38 pm), http://www.bloomberg. com/news/articles/2015-01-15/ebola-flourished-after-who-s-2010-warning-ignored-report-says [https://perma.cc/c7pp-cvrd]. 286 indiana health law review [vol. 15:247 suk suggests that these shortcomings may be due to the high stakes involved for nation states in having a pheic declared within their borders. such a status not only mandates the who: to issue both temporary and standing (but non-binding) recommendations for implementations to be adopted by the affected who member state as well as other who member states (articles 15-18)…[but could also]…have immediate economic ramifications for the country in which the disease event is occurring, either through declines in tourism, decreased demand for exports or, worse, trade embargoes.268 evidence of this can be gleaned from both the recent ebola outbreak as well as the 2003 sars outbreak. for example, in 2013, sierra leone and liberia ranked second and sixth among the top ten countries with the highest gdp growth in the world, and guinea had high hopes for its simandou iron ore project on to which numerous international investors had signed. today, the economies of both269 these countries are still recovering in the aftermath of the ebola outbreak. nigeria, in turn, where only twenty cases were reported, witnessed a 40% drop in demand for goods and services in its largest economic hub, lagos. and even270 ghana and cote d’ivoire, where no cases were reported, experienced an economic impact with international conferences being cancelled, reduced flights, and fewer tourists. 271 particularly interesting about the economic impact of the most recent ebola outbreak in africa was the observation that “the largest economic effects of the crisis are not as a result of the direct costs (mortality, morbidity, caregiving, and associated losses to working days) but rather those resulting from aversion behavior driven by fear of contagion.” this fear was stoked by inaccurate and272 implausible claims by international institutions like the who and the cdc. an early example of how data was misleadingly represented was the who statements from april through august 2014 that the death rate from ebola was up to 90%, while the actual death rate from confirmed cases, even in the early days in march 2014 in guinea, was about 70%. both the who and the cdc273 misjudged how the disease would evolve, both overestimated likely cases, and the cdc projected that up to 1.4 million people in liberia and sierra leone could be infected by january 2015, while only 19,140 cases had been reported in both countries by 27 january 2015. in october 2014, the world bank estimated that274 268. suk, supra note 148, at 1. 269. sy & copley, supra note 192. 270. thomas jaye & fiifi edu-afful, ebola: impact and lessons for west africa (2014). 271. id. 272. juliana mercer, the birthplace of disease, pennstate: olead 410: leadership in a global context, cultural leadership blog (apr. 29, 2015), https://sites.psu.edu/global/ 2015/04/29/the-birthplace-of-disease/ [https://perma.cc/4wtr-4cpv]. 273. id. 274. id. 2018] international and operational responses to disease control 287 the total costs associated with ebola for west africa were as high as $32.6 billion, an estimate which was revised in january 2015 to $6 billion at most.275 such inaccurate and implausible claims stoked panic and ultimately had direct and indirect economic consequences for the countries concerned. 276 most vulnerable in the face of such misleading information is the informal economy, where farmers are often unable to organize work teams which in turn affects harvests and lead to food insecurity and women are unable to sell their goods at markets and other public places due to the debilitating effect of fear on people to make use of public transport or to gather in public places. such indirect economic consequences were particularly evident in sierra leone, where no differences were found in labor impacts between quarantined and nonquarantined districts. fear was also the primary determinant of behavior277 curbing economic activity, and is estimated to have contributed as much as 80% to 90% of the total economic impact of the sars epidemic in 2002-2004, an epidemic that cost the world economy a staggering usd $40 billion. 278 the economic repercussions of having a pheic declared within a country’s borders are therefore a real and valid concern. but in the aftermath of the most recent outbreak of an epidemic, and particularly in light of the calamity thereof, we have to consider what this means for forging a robust international response framework for the spread of infectious disease. a project that we seemingly continue to fail at as epidemics continue to overwhelm the international epidemic bulwark. there are no simple solutions to this complex problem, the multifacetedness of which was evident from the transdisciplinary narration of the two health panics described above. the remainder of this part of the article will focus on two identified shortcomings of the international legal and operational framework for public health emergencies and disease control: the first being who the relevant body is that should take primary responsibility in case of an epidemic or other public health emergency, and the second question being how the coordination of such a public health event should be informed and steered. b. who is responsible? from state sovereignty to collective responsibility a possible reason for the inability of the international community to forge a robust international framework for the spread of infectious disease can be found in the very nature of international law, and became apparent early on in the consultation process to the ihr (2005). concerns about state sovereignty were raised in respect of several different aspects of the ihr (2005) and in essence 275. id. 276. sy & copley, supra note 192. 277. ebola hampering household economies across liberia and sierra leone, the world bank (jan. 12, 2015), http://www.worldbank.org/en/news/press-release/2015/01/12/ebolahampering-household-economies-liberia-sierra-leone [https://perma.cc/djv4-d8nc]. 278. sy & copley, supra note 192; jonathan e. suk et al., enhancing public health preparedness: towards an integrated process, 21:3 eurohealth int’l 36, 36 (2015). 288 indiana health law review [vol. 15:247 dealt with the extent of interference by the who within member states’ territory once a pheic is declared, as well as the “excessive” or “additional” obligations placed on member states to take a number of measures to prevent, respond, and to control the spread of disease and to implement appropriate measures within its domestic legal and public health systems. on the one hand, states want to279 protect their sovereignty with regard to the scope of their national regulatory autonomy over all matters related to health. on the other hand, the globalized international community is in need of some form of protection from, and power to intervene and prescribe when, a public health emergency or the risk thereof is imminent. yet, it is important to remember that as with most other international legal instruments, the international legal obligations created are, for the most part, voluntarily assumed and generally rely on the “auto-interpretation—[of]280 each state interpreting and applying norms for itself rather than following the prescriptions of a higher authority.”281 the nation states where disease outbreaks occur therefore remain the primary responsible actors and duty holders under international law and in protecting the health, well-being, and dignity of their population, and ultimately the international community at large. this “responsibility to protect” (“r2p”) was282 endorsed by the general assembly resolution 2177 (2014) and while it is primarily intended as a response to war crimes, genocide, and crimes against humanity, brigit and moore have convincingly argued that it also applies to283 “situations of widespread poverty, malnutrition and outbreaks of infectious diseases.” moore describes the application of r2p in terms of concentric circles284 of responsibility starting with the individual state’s obligation to ensure the well-being of its own people; nested within the collective responsibility of the community of nations to assist individual states in meeting those obligations; in turn encircled by the responsibility of the united nations to respond if necessary to ensure the basic rights of civilians, with 279. von tigerstrom, supra note 123, at 55. 280. see james crawford, brownlie’s principles of public international law 594-97 (8th ed. oxford u. press 2012) (noting the important relevance of the peremptory norms (jus cogens) of international law. the international law commission identified and incorporated these norms in the vienna convention on the law of treaties. thus, “a norm from which no derogation is permitted and which can be modified only by a subsequent norm of general international law having the same character,” is regarded as a peremptory norm. examples of peremptory norms are the prohibition of the use of force contrary to the u.n. charter, the prohibition of crimes under international law such as genocide and crimes against humanity, and the prohibition of slavery.). 281. von tigerstrom, supra note 123, at 57. 282. toebes brigit, the ebola crisis: challenges for global health law, shares (feb. 4, 2015), http://www.sharesproject.nl/the-ebola-crisis-challenges-for-global-health-law/ [https://perma.cc/py7d-53pp]. 283. s.c. res. 2177 (sept. 18, 2014). 284. id. 2018] international and operational responses to disease control 289 military means only contemplated as a last resort, and only with the consent of the security council.285 likewise, international human rights law can also be used to frame the rights of peoples and the obligations of states in a public health emergency. coomans argues that a public health emergency is ultimately a matter relating to the right to health, and signatories to the international covenant on economic, social and cultural rights (“icescr”) are obliged to progressively realize the right of286 people to the enjoyment of the highest attainable standard of physical and mental health under article 12(1). states must therefore progressively realize and287 ensure that a minimum core of a properly functioning health system and infrastructure, as well as adequate health-system capacity, exists for people to gain access to health services. article 12(2) furthermore specifically states that288 the full realization of the right to health include actions relating to the prevention, treatment and control of epidemic, endemic, occupational and other diseases, and the creation of conditions which should ensure to all medical service and medical attention in the event of sickness. 289 in moving beyond the immediate responsibilities of states, the international community also has responsibilities with regard to public health emergencies under international law. the u.n. committee on economic, social and cultural rights has said “given that some diseases are easily transmissible beyond the frontiers of a state, there is a collective responsibility on the international community to address this problem. the economically developed states parties have a special responsibility and interest to assist the poorer developing states in this regard.” and, article 2(1) of the icescr provides that state parties should290 realize the rights in the covenant “individually and through international assistance and co-operation, especially economic and technical.” brigit also291 submits that this international “duty to aid” under human rights law is congruent 285. jennifer moore, the responsibility to protect in the ebola outbreak, oupblog (sept. 22, 2014), http://blog.oup.com/2014/09/responsibility-protect-r2p-west-africa-ebola-outbreak-pil/ [https://perma.cc/7ssn-thje]. 286. international covenant on economic, social and cultural rights, dec. 16, 1966, s. treaty doc. no. 95-19, 6 i.l.m. 360 (1967), 993 u.n.t.s. 3 [hereinafter icescr]. 287. fons coomans, ebola and the human right to health, maastricht l. news & views (oct. 28, 2014), http://law.maastrichtuniversity.nl/newsandviews/author/prof-dr-fons-coomans/ [https://perma.cc/fv95-ehm2]. 288. brigit, supra note 282. 289. coomans, supra note 287. 290. u.n. comm. on econ., soc., and cultural rights (cescr), gen. comment no. 14: the right to the highest attainable standard of health (art. 12) e/c.12/2000/4, at 40 (aug. 11, 2000); see generally maastricht principles on the extraterritorial obligations of states in the area of economic, social and cultural rights, eto consortium (sept. 2013), http://www.etoconsortium. org/en/main-navigation/library/maastricht-principles/ [https://perma.cc/d9df-w37d]. 291. brigit, supra note 282. 290 indiana health law review [vol. 15:247 with the r2p. while non-state actors like civil society organizations,292 humanitarian aid organizations, and the pharmaceutical industry are not directly bound by standards of international or global health law, brigit argues that they have moral duties to comply with human rights standards, including the right to health. this moral duty, brigit argues, is particularly warranted given the influence and power of these non-state actors over the health and well-being of people.293 however, and as was already indicated above, while international legal instruments like the ihr (2005) and the concomitant obligations that it places on member states requires an inevitable compromise between national sovereignty and the collective international good, these obligations remain—like many others in the realm of international law—mere ideals subject to competing claims and intricate political and economic negotiations. in the next section therefore, the discussion will return to the national level, and more specifically to the people directly affected by the outbreak of disease. c. revisiting the ‘how’: knowledge production beyond the boundaries of disciplinary confines article 43(2) of the ihr (2005) requires that all health measures prescribed in the ihr (2005), including how and when a pheic is declared, be informed and directed in terms of bio-medical knowledge. no mention is made, however,294 of the social and cultural contexts in which public health emergencies play out, and how context specific information about the environment, relevant social and cultural factors, and even political considerations, should inform health measures and strategies. moreover, the predominant top-down approach so archetypical of legal and regulatory frameworks does little to foster communication and trust, and essentially sidelines community engagement as a critical operational tool. this295 is not only regrettable but ultimately also counter-intuitive to the public health ideal as community engagement is an essential resource in any public health emergency. it is, for example, through community engagement that people are equipped with the knowledge, capabilities and support to prevent themselves and others from falling prey to an emerging or ongoing epidemic—large-scale fear and resistance to health authorities as well as stigmatisation can be reduced, safe and supportive practices of care for those already infected can be ensured, and safe burial practices promoted. yet, the social and cultural contexts in which296 public health emergencies play out are often ignored and are definitely not considered in terms of the execution and operation of international and national legal frameworks. 292. id. 293. id. 294. for a discussion of the various “sound science” clauses included in the ihr (2005) see suk, supra note 148, at 1-5. 295. dubois et al., supra note 17, at 29. 296. see supra text accompanying note 17. 2018] international and operational responses to disease control 291 international responses to disease outbreaks usually regard local culture as an impediment, and place overt emphasis on a strategy that “places responsibility for disease transmissions on individuals who are expected to reject ‘negative’ behaviours such as communical eating or burial traditions, while failing to provide sufficient resources to those same individuals to enable their ‘appropriate’ management of the disease.” the most recent ebola outbreak is297 a case in point—assumptions about local ignorance and capabilities led to false attributions being made to the indigenous peoples of the affected areas and their culture, while much of the community resistance was not related to indigenous traditions “but [rather] basic issues like people seeing family members taken away and never getting news about where they end up or how they are doing.”298 such stereotypes not only feed paternalism, but the consequences thereof directly impact the international and national legal and regulatory responses to public health emergencies. it has been said, for example, that “[t]he apparent result is a predisposition in the aid system towards control and an inflated sense of its own importance, rather than responses and strategies that engage with and rely on communities, and demand action from them.” 299 a new integrated approach is therefore required for international norm-setting that is holistic, multidisciplinary, and globally oriented. the strictures of disciplinary boundaries, whether biomedical or legalistic, are rigid, hierarchical, and often keep us from effectively responding to health needs and impediments on the ground. this was indeed evident from the most recent ebola outbreak where the troubling gap and powerful potential of community engagement stood glaring in the aftermath of many lives lost. such a call for a more integrated300 approach beyond disciplinary confines is indeed not novel, but was already articulated shortly after the 2003 sars outbreak by arthur kleinman and james watson who said: seen in the context of avian flu and the major outbreaks of flu in the twentieth century—most of which appear to have originated in south china—the sars epidemics must be found. virologists need to work in teams consisting of ecologists, biologists, soil scientists, economists, political scientists, demographers, epidemiologists, anthropologists and ethicists. this is the only way we can hope to understand the intersection of ecological, social, and biological processes that underline emergent infectious diseases. at issue here are the migration of waterfowl, the intensive cultivation of ducks, chickens, and pigs in settings of dense human habitation, trade in and sale of wild animals, the migration of 297. id. 298. kari lydersen, ebola teams need better cultural understanding, anthropologists say, discover mag. (dec. 9, 2014), http://blogs.discovermagazine.com/crux/2014/12/09/ebolacultural-anthropologists/ [https://perma.cc/rn97-rncg]. 299. dubois, supra note 17, at 30. 300. see supra note 17, at 30. 292 indiana health law review [vol. 15:247 workers and the complexities of local cultural practices.301 somewhere between parochialism and cosmopolitanism is a point where the abstract logic of the international and the very real concerns of the local meet. the meeting point does not have to be as belligerent as per dubois and wake, who argue that the most recent ebola outbreak has set the scene for what will be a “battleground between health security, humanitarian health and the authority of transnational institutions” in the future. but the tension between international302 and local concerns can produce a positive outcome, thus contributing to a multifaceted and integrated approach that is not only sensible in terms of diversity of knowledge systems, but also legitimate to a degree not yet experienced. vii. conclusion this article offered a chronicle of the rise and fall of two notable epidemics of the modern world. in utilizing a trans-disciplinary lens in considering the international, operational and national legal frameworks in which these two epidemics ran its course, it is shown that the extent of biomedical knowledge available on a disease, an epidemic, or a public health emergency has little bearing on how successful states and the international community at large will be in effectively responding thereto. the first ebola outbreak occurred in 1976 in sudan and the democratic republic of congo (then zaire) and much of the findings of the zaire and sudan commissions that were established in the immediate aftermath of these outbreaks still hold true today. yet, with the most recent ebola outbreak in which more than 27,200 people were infected and more than 111,000 died, serious questions have been raised about the preparedness of the international community and its representative structures in dealing with public health emergencies. this stands in stark contrast to the 2003 sars outbreak on which no scientific bio-medical information was available at the outset of the epidemic, but the epidemic was successfully contained within months of the first reported case and with only 774 attributable deaths. these two notable public health emergencies remain important in evaluating international and operational responses to disease control as both gave rise to “historic” developments in terms of the international legal regulation of disease. the current legal instrument for the control of the spread of disease, the ihr (2005), is a direct culmination from the 2003 sars outbreak. additionally, the recent ebola outbreak led to the un security council adopting resolution 2177, confirming the ebola outbreak to be a threat to international peace and security and establishing unmeer as a temporary measure to coordinate the work of u.n. entities with other organisations and all governments involved. however, these two outbreaks also confirmed the paradox of being “a global village in a divided world;” as we were again reminded of how increasingly interdependent303 301. arthur kleinman & james l. watson, introduction: sars in social and historical context, in sars: prelude to pandemic? 14, 14 (stan. u. press 2005). 302. dubois, supra note 17, at 40. 303. obijiofor aginam, global health governance: international law and public 2018] international and operational responses to disease control 293 we are, especially in the face of a public health emergency. yet, it is not only the various organisations, structures, and stake-holders at the international and national levels that must continue to work towards an effective international response framework. this will not be enough, because: [u]nlike a tsunami or an earthquake, the impact of an outbreak is insidious: human-to-human transmission is slow to reveal itself, and, most important, the spread and control of a disease epidemic hinges on attitudes and behaviours, many of them determined by how local populations feel about the people who are assigned to care for their health.304 sight must therefore never be lost of the important role that the people most affected by a public health emergency can play in the operational responses to disease control. recognizing people’s agency in this manner has a long-term benefit that goes beyond the mere pragmatic to create new avenues of knowledge production not only for the sake of ending a crisis, but indeed as a function of interdisciplinary and intersectional cooperation. international and operational responses to disease control, historically reactionary in nature, can benefit from a more proactive and interdisciplinary approach that moves to capacitates the local in order to deal with the relentless transnational. health in divided world (u. toronto press 2005). 304. marie-paule kieny, human emotion is the variable in the ebola crisis, aljazeera (may 9, 2015), http://www.aljazeera.com/indepth/opinion/2015/05/human-emotion-variable-ebola-crisis150507114647088.html [https://perma.cc/p9q2-2u4c]. the law, economics, and governance of generation covid-19 long-haul julia puaschunder* & martin gelter** abstract*** the sars-cov-2 novel coronavirus is an external shock to all societies with lasting impacts that have changed individual, political, and corporate decisions profoundly. increasing evidence reveals that an estimated 10-50% of those previously infected with covid-19 face a longer-term or long-term health impact and/or chronic debilitation that in many cases comes and goes in waves. this phenomenon has already been referred to as a pandemic within the pandemic. the broad-based and long-term impact of covid long haulers have also holds the potential to change our world and modern society, lasting through the following three outlined speculative trends: (1) the coronavirus crisis has widened novel and already existing inequalities, of which the rather surprising finance performance versus real economy liquidity constraint gap led to unequal emotional and sociopsychological crisis fallout propensities. corporate governance and political economy power dynamics may shift in the eye of long haulers’ relation to work and a healthy, productive environment. employers will likely face pressure to create a safe and secure working environment but also have rising tort liability risks that may be mitigated by hiring health consulting agents. proactive care for maintaining a healthy workforce and the overall long-term well-being of employees, including preventive care in teams, will become an essential corporate feature to attract qualified labor, whose bargaining power increased in the eye of labor shortages in direct contact industries and positions. (2) long haulers may initiate an artificial intelligence revolution of self* columbia university; the new school, department of economics and the new schools of public engagement. ** fordham university school of law; research member, european corporate governance institute. *** for helpful comments on ideas that led to this article, we thank participants of the 16th annual conference of the italian society for law and economics (side-isle); the united nations unequal world conference: the right to education: transforming the world through inclusive quality education; the research association for interdisciplinary studies (rais) conference; university of ohio, moritz college of law, ohio state business law journal symposium confronting crisis: preparing for the unexpected; the monitoring and evaluation (m&e) collaborative association (meca) 2021 conference; the european commission directorategeneral health and food safety; the comparative private law lecture, universität innsbruck & università degli studi di padova scuola di giurisprudenza; centre for corporate sustainability and environmental finance, department of applied finance, macquarie business school; indian institute of finance international research conference & award summit; council of european studies (ces) 27th annual conference of europeanists, the ecowellness group, and the 6th annual international conference digital czech republic 2021. 48 indiana health law review [vol. 19:47 monitoring and constant health status tracking, but also democratization of healthcare information. artificial intelligence, robotics, and big data offer essential complements to fill in for long-haul attention and productivity deficits that may occur in waves. long haulers have already found themselves in online self-help groups – such as survivor corps – for quick and unbureaucratic information exchange about an emerging group phenomenon. social online media platforms served as an easy remedy during a time when a surge of severe covid cases precluded covid hospitalization. nowadays, covid long-haul patients have become – more than ever before – citizen scientists that bundle decentralized information on their health status and potential remedies in order to inform the medical profession about newly emerging trends. the rise in medical self-help and mutual support will have profound implications for the regulation of the medical profession and will likely stretch the medical remedy spectrum and boost alternative medicine. in the online exchange of sensitive information about one’s health status, citizen scientists are also particularly vulnerable in terms of their privacy, potentially even more susceptible to online marketing campaigns under medically impaired conditions, but also because of their sensitive information having been publicly disclosed online over time. (3) as historical precedents show, generation covid long-haul partially being recognized as a disability may result in increased pressures to reform social, healthcare, and retirement systems. given waves of debilitation, the analysis of macroeconomic aggregates will have to change in order to reflect a more diversified and temporal view of social preferences. future economic policy research may take inspiration from the legal concept of disparate impact. behavioral insights on how to navigate the world with attention deficits and uncertainty may focus on developing an idea of the economic benefits of rest by incorporating preferences for minimalism in a turbulent world longing for recovery. i. introduction the novel coronavirus that first emerged in 2019 is perhaps the most unexpected global shock in the modern era. covid-19 dramatically changed behavioral patterns around the world and will have a lasting impact on society.1 by now, over 250 million recorded infections2 have caused over 5 million 1. see economics in the time of covid-19 (richard baldwin & beatrice weder di mauro eds., 2020), https://cepr.org/sites/default/files/news/covid-19.pdf [https://perma.cc/g3x7qun5] (giving a general overview of the crisis and economic fallout). 2. this figure includes multiple infection counts but excludes those infected, who did not test for a covid-19 infection. 2022] generation covid-19 long-haul 49 documented deaths3 in more than 220 countries and territories around the globe.4 according to estimates, the actual number of infections is four to thirteen times the reported and recorded case numbers.5 without even considering the variants that have emerged, early scientific estimates predicted that about 80% of the world’s population would get infected with the virus at some point, with the greatest impact in densely populated areas.6 with the initial virus being replaced by different variants, epidemiologists increasingly believe that all human beings will have touchpoints with covid at some point in their lives.7 over the course of the spread of the novel coronavirus, people around the world have become aware that taking preventive measures can limit the spread of the deadly and debilitating virus – including social distancing and social contact tracking, collective and individual hygiene, preventive healthcare and foresighted nutrition, as well as vaccination and medication.8 the further the 3. mortality count varies by country, but in general includes all who were tested as infected at the moment of death. the figure does not count for death due to coronavirus externalities, such as suicide without infection, those who died without having covid-19 but did not get medical attention, or help due to hospital capacity constraints or delayed medical attention. 4. see coronavirus cases, worldometer, https://www.worldometers.info/coronavirus/ [https://perma.cc/9bmj-fdkh] (last visited dec. 28, 2021). 5. deidre mcphillips, study estimates us covid-19 infections may be 4 times higher than reported, cnn (jan. 5, 2021, 11:14 am), https://www.cnn.com/world/live-news/ coronavirus-pandemic-vaccine-updates-01-05-21/h_833be27384fd892bf390e72fe3f34b1e [https://perma.cc/2cr7-a52p]; nurith aizenman et al., coronavirus by the numbers: why the pandemic is 10 times worse than you think, npr (feb. 6, 2021, 5:01 am), https://www.npr.org/ sections/health-shots/2021/02/06/964527835/why-the-pandemic-is-10-times-worse-than-you-think [https://perma.cc/wef7-3sb4]; apoorva mandavilli, coronavirus infections much higher than reported cases in parts of u.s., study shows, n.y. times, https://www.nytimes.com/2020/ 07/21/health/coronavirus-infections-us.html [https://perma.cc/2bff-n25q] (last updated aug. 17, 2020). 6. see '50-80% of population' could be affected by coronavirus, bbc news (mar. 2, 2020), https://www.bbc.com/news/av/uk-scotland-51711747 [https://perma.cc/7la9-2s27]; jungsik noh & gaudenz danuser, estimation of the fraction of covid-19 infected people in the u.s. states and countries worldwide. 16 plos one 1 (2021). 7. sarah zhang, the coronavirus is here forever. this is how we live with it, atlantic (aug. 17, 2021), https://www.theatlantic.com/science/archive/2021/08/how-we-live-coronavirusforever/619783/ [https://perma.cc/9u5f-6wjj]. 8. how scientists predict how many people will get covid-19, webmd (apr. 1, 2020), https://www.webmd.com/lung/news/20200401/how-scientists-predict-how-many-people-will-getcovid-19#1 [https://perma.cc/p6gp-rka7]; arielle harrison, 70% of covid long haulers have impaired organs up to 4 months after infection, study finds, kutv (apr. 27, 2021), https://kutv.com/news/local/70-of-long-haulers-have-impaired-organs-up-to-4-months-after-covid19-infection [https://perma.cc/85lf-ajxb]; robert roy britt, new survey identifies 98 longlasting covid symptoms, elemental (aug. 14, 2020), https://elemental.medium.com/new-surveyidentifies-98-long-lasting-covid-symptoms-87935b258a3e [https://perma.cc/6vsu-p5dz]; julia m. puaschunder, generation covid-19 long haulers, scientia moralitas conf. proc., apr. 50 indiana health law review [vol. 19:47 covid-19 healthcare crisis deepened, the more it became apparent that in some previously-infected individuals the virus lingers to the point of debilitation and often changes health conditions long term. from 10% to upwards of 50% of those previously infected with covid develop long-term symptoms of the disease, which are often diffuse, come in waves, and – to this day – are not well understood.9 some of these ongoing long-haul patients seem to recover completely, but simply take more time to do so than the average fourteen-day recovery period. on the other hand, some patients still struggle a long time after their initial infection – potentially due to an immune system reaction and an overactivation of the body’s unspecific immune system and/or an awakening of an autoimmune disease or other previous infections (causing complications such as shingles).10 with this broad-based and long-term impact on the status of health of society in mind as a driver of societal well-being and productivity, and with no direct cure against the long-term implications of covid-19 at hand yet, we can say that covid-19 will be the most impactful external shock triggering lasting change in our lifetimes.11 from the history of humankind and the knowledge about previous diseases, we can draw the inference that crises have always been turning points and ultimate spring feathers of lasting societal development.12 this article argues that 19, 2021, at 99-104; see also rita rubin, as their numbers grow, covid-19 “long haulers” stump experts, 14 j. am. med. ass’n 1381 (2020); jeffrey d. sachs et al., commentary, the lancet covid-19 commission, 396 the lancet 454, 455 (2020). 9. robert hart, long covid has over 200 symptoms and leaves 1 in 5 unable to work, study finds, forbes (july 15, 2021, 9:39 am), https://www.forbes.com/sites/roberthart/2021/07/ 15 /long-covid-has-over-200-symptoms-and-leaves-1-in -5-unable-to-work-studyfinds/?sh=7f71338e5eb2 [https://perma.cc/ff56-l8jc]; linda searing, 50 percent of people who survive covid-19 face lingering symptoms, study finds, wash. post (nov. 15, 2021, 8:00 am), https://www.washingtonpost.com/health/long-covid-50-percent-lingering-symptoms/ 2021/11/12/e6655236-4313-11ec-9ea7-3eb2406a2e24_story.html [https://perma.cc/g9qj-uphk]. 10. drbeen medical lectures, spike proteins in immune cells: dr. bruce patterson discusses covid long haul, youtube (june 24, 2021), https://www.youtube.com/watch?v= jwjjs5zhkji [https://perma.cc/nqz9-e362]; see also célia márcia fernandes maia et al., increased number of herpes zoster cases in brazil related to the covid-19 pandemic, 104 int’l j. infectious diseases 732. 11. justine coleman, cdc study on covid-19 long-haulers: two-thirds of nonhospitalized patients receive new diagnoses, hill (apr. 23, 2021, 12:07 pm), https://thehill.com/ policy/healthcare/549950-cdc-study-on-covid-19-long-haulers-two-thirds-of-non-hospitalizedpatients [https://perma.cc/3l3x-eeb6]; changing places, economist (oct. 8, 2020), https://www. economist.com/special-report/2020/10/08/changing-places [https://perma.cc/6ted-y3la]; postcovid syndrome: researchers are closing in on long covid, economist (apr. 29, 2021), https://www.economist.com/science-and-technology/2021/04/29/researchers-are-closing-in-onlong-covid [https://perma.cc/bv3j-83vk]. 12. see paul schmelzing, staff working paper no. 845: eight centuries of global real interest rates, r-g, and the ‘suprasecular’ decline, 1311-2018, bank eng. 1 (2020); interdisciplinary, multimedia conference on july 14th and 15th, 2020, ecowellness, 2022] generation covid-19 long-haul 51 covid-19 has the potential to dominate future individual, political, and corporate decisions directly or indirectly, but certainly profoundly. the largescale dimension of covid-19 infections around the world is underscored by an estimated 10-50% of those previously infected with covid-19 facing some kind of longer-term or long-term health impact and/or chronic debilitation that is currently not well-understood by the medical profession.13 given the worldwide spread of the virus and that the demographic likelihood to become a covid long hauler peaks in the 30-50 years of age bracket, we can predict a large-scale, long-term and global impetus of covid long-haul induced change. this article argues that the phenomenon of long-haul covid has the potential to transform our world and modern society. with attention to other historical examples – such as the post-world war ii era – we speculate about three potential major developments. the presence of a generation of covid long haulers has the potential to change the law, economics, and governance through the following predictive and debatable trends: (1) in the overall economy, the covid-19 crisis with lockdowns and urgent healthcare needs has produced a major consumption shift that has produced winning and losing industries. the finance world has largely been able to avoid harm by diversifying and flexibly replacing winning for losing industries in wellmanaged portfolios, as well as by shorting and hedging of sectors with a prospective loss during the crisis. at the same time, the real economy has often been hit by bankruptcy and liquidity constraints that played out in harmful choices and negative socio-psychological fallouts. all of this has widened an exacerbating finance performance versus real economy gap. corporate and political power dynamics may shift in light of long haulers’ relation to work and their appreciation of a healthy environment to be productive. employers will likely face pressure to create a safe and secure working environment. employers may also have rising tort liability risks that may be mitigated by hiring health consultants. pro-active care for maintaining a healthy workforce and the overall long-term well-being of employees, including preventive care in teams, will become an essential corporate feature to attract qualified labor, whose bargaining power increases in the eye of labor shortages in human-facing industries and positions.14 https://www.oekowellness.de/laenderuebergreifende-konzerenz-zum-thema-system-change-diechance-der-transformation-des-gesundheitswesens-14-07-2020/ [https://perma.cc/cu74-rj5d] (last visited aug. 12, 2020). 13. hart, supra note 9; searing, supra note 9. 14. teresa ghilarducci, are firms causing people to quit? quits rate increasing to 2.7%, forbes (aug. 14, 2021, 11:32 am), https://www.forbes.com/sites/teresaghilarducci/2021/08/14/ are-firms-causing-people-to-qu it-qu its-rate-increasing-to-27 /?sh=3a18e42d35d0 [https://perma.cc/ly22-8wc3]; robbie whelan, high pay for covid-19 nurses leads to shortages at some hospitals, wall st. j. (aug. 29, 2021, 12:11 pm), https://www.wsj.com/articles/high-payfor-covid-19-nurses-leads-to-shortages-at-some-hospitals-11630253483 [https://perma.cc/rn8cam2v]; bertrand benoit & tom fairless, germany boosts already hefty coronavirus stimulus, wall st. j. (aug. 26, 2020, 7:09 am), https://www.wsj.com/articles/germany-boosts-already52 indiana health law review [vol. 19:47 historically, ancient epidemics were turning points that eventually fostered innovation and mechanization in view of human labor shortage and a reduction of productive capacity. generation covid-19 long-haul will likely turn to digitalization and may erode resistance against artificial intelligence taking over tasks previously performed by humans. (2) artificial intelligence, robotics, and big data offer essential complements and insights to substitute for long-haul attention and productivity deficits that may occur in waves. covid-19 long haulers may embark on an artificial intelligence revolution triggered by medical self-monitoring, constant health status tracking, and real-time scanning of their environment for harmful aerosols with it solutions. the social media instant information exchange may also lead to a democratization of healthcare information without medical professionals as gatekeepers. long covid patients are a self-identified disease group as long haulers have already found themselves in online self-help groups – such as survivor corps – for quick and unbureaucratic information exchange about an emerging group phenomenon. social online media platforms served as easy remedies during a time when a surge of severe covid cases precluded covid hospitalization. the congested situation in intensive care units around the world has driven a trend of covid long-haul patients becoming citizen scientists who bundle decentralized information on their health status and potential remedies in online social media forums in order to inform the medical profession about newly emerging trends. the rise in medical self-help and mutual support will have profound implications for the regulation of the medical profession and will likely boost alternative medicine and over-the-counter drugs. implicit monopolization of pharmaceutical markets and biased subscription favoritism may become harder when access to healthcare information and medication remedy but also side effects become more transparent in the digital age. at the same time, however, in the instant online exchange of sensitive information about one’s health status, citizen scientists are particularly vulnerable in terms of their privacy and potentially susceptible to online marketing campaigns under medically impaired conditions. the legal profession at the forefront, but also regulatory agencies overseeing the market and society at large will have to find solutions to protect long haulers in their public disclosure of sensitive information online over time. (3) with reference to historical precedents of the past, generation covid long-haul partially being recognized as a disability may result in increased pressures to reform social, healthcare and retirement systems on a large scale. especially when considering the relatively young age of covid-19 long-hauling onsets, which is currently estimated to peak around the ages of 30 to 50, the longterm impetus of this usually highly productive part of society being slowed and/or weakened will be substantial when considering the expected decline in tax revenue from this age group’s working income. given that around 70 to 75% of long haulers are currently estimated to be female, but also taking into account that about one third of all long haulers’ hefty-coronavirus-stimulus-11598440184 [https://perma.cc/z35g-vvxa]. 2022] generation covid-19 long-haul 53 symptoms come in waves during debilitating covid long-haul episodes, the future analysis of macroeconomic aggregates and policy impacts is likely to reflect a more diversified gender-sensitive and temporal view of social preferences under unpredictably changing conditions.15 future economic policy research may be inspired by the legal concept of disparate impact, which could help elucidate the aggregate production function calculus as the standard measure of economic growth. it could also inform a more diversified and individual intertemporal discounting function. behavioral insights on navigating a turbulent world with attention deficits and under uncertainty about health status conditions may become fundamental for developing an idea of the economic benefits of rest by incorporating preferences for minimalism in a complex world longing for recovery. speculating about these potential future trends lies at the core of navigating through a turbulent time with vigilance. after all, history offers a vital account of multiple records when crises, upheaval and periods of severe social and economic disruptions and their following recovery periods became essential turning points for lasting societal change and spring feathers of eventual betterment. overall, these consequences allow us to draw larger lessons for law, governance, and economic analysis. in the future, we may see a reconfiguring of institutions in many jurisdictions and a different understanding of health and well-being contributing to a more behaviorally informed economic profession. social and economic phenomena, such as corporate governance, are sometimes analogized to biological evolution.16 as the shock of the pandemic had an immediate effect on all countries around the world, covid-19 long-haul is likely to change the larger economic environment and societal structure of modern democracies for years to come. we can expect covid-19 and a growing pandemic of long-term debilitated to cause substantial changes in corporate governance and related fields that will have a lasting impact for our future to come. thus, as long-haul symptoms persist, we are likely to see direct and indirect persistent effects in the future. taking this net of diverse effects together, the article ends with public policy recommendations and guidance for implementation paying attention to contemporary and anticipated long-haul patterns and trends. in the wake of ambitious bailout and recovery plans, a law and economics view could highlight necessary disparate impact facets of economic fallouts to a common crisis that should be considered when choosing capital transfer targets strategically and driven by fairness mandates and with a 15. rubin, supra note 8. 16. see martin gelter & julia m. puaschunder, covid-19 and comparative corporate governance, 46 j. corp. l. 557 (2021); amitai aviram, evolutionary models of corporate law, rsch. handbook on hist. corp. & co. l. 596, 602-606 (2017); m.b.w. sinclair, the use of evolution theory in law, 64 u. det. l. rev. 451, 451-52 (1987) (noting legal evolution is necessarily lamarckian); simon deakin, evolution for our time: a theory of legal memetics, 55 current legal probs. 1 (2002); simon deakin & fabio carvalho, system and evolution in corporate governance, eur. corp. governance inst. 111 (2010); mark j. roe, commentary, chaos and evolution in law and economics, 109 harv. l. rev. 641, 664 (1996). 54 indiana health law review [vol. 19:47 long-term view in mind to breed harmony within society and between generations.17 as for scientific advancements, generation covid long-haul has the potential to imbue minimalism, rest, and recovery as central axioms around which economic calculus is newly focused. all measures laid out18 point toward fundamental societal changes.19 governments around the globe have therefore set out on a course to avert the negative impetus of the covid-19 pandemic economic shock.20 this article aims to address these major trends and developments that are unique features of the covid-19 crisis to highlight their relevance in determining future-oriented policies and multifaceted recovery aid.21 overall, we argue that the covid-19 pandemic, as the most massive exogenous shock and subsequent policy changes in relation to a drastic long-term health status shift of major parts of the productive workforce and society, has the potential to change many aspects of the individual consumer, the family compound, societal care systems, and economic incentives for market actors and industries. paying attention to anticipated disruption fallouts will aid governments around the world in confronting the crisis but also to reinterpret the way we produce, consume and – most importantly – live our lives productively, healthily, and within a fair society that acts in harmony with the environment. by learning from our history, and in particular from the resilience exposed to previous crises, we will hopefully emerge from covid-19 stronger as a society in the long term and with gifts of better lives for future generations to come.22 this article proceeds as follows. part 2 describes the impact of the external shock of covid-19 on humankind with particular attention to the covid longhaul phenomenon. part 3 explores three long-haul trends. first, section 3.1 discusses governance and political economy power dynamic shifts in view of long haulers’ relation to work, paying attention to an unprecedented demand for a healthy productive workplace environment. next, section 3.2 highlights the potential of artificial intelligence, robotics, and big data to fill in for long-haul 17. julia margarete puaschunder, focusing covid-19 bailout and recovery, ohio state bus. l.j. (forthcoming). 18. see a crisis like no other, an uncertain recovery, int’l monetary fund 1 (2020); lawrence o gostin et al., comment, a global health action agenda for the biden administration, 397 lancet 5, 6 (2021) (“covid-19 has unleashed vast economic, social, and health crises.”). 19. see julia m. puaschunder & dirk beerbaum, healthcare inequality in the digital 21st century: the case for a mandate for equal access to quality medicine for all (sept. 28, 2020) (unpublished manuscript) (on file with author). 20. see, e.g., ziyad cassim et al., the $10 trillion rescue: how governments can deliver impact, mckinsey & co. 1 (2020); press release, president joe biden, president biden announces american rescue plan (jan. 20, 2021), https://www.whitehouse.gov/briefing-room/legislation/ 2021/01/20/president-biden-announces-american-rescue-plan/ [https://perma.cc/w6nc-falp]. 21. princeton bendheim center for finance, a conversation with lawrence h. summers and paul krugman, youtube (feb. 12, 2021), https://www.youtube.com/watch?v=ebz3_lzxs54 [https://perma.cc/7457-udxv]. 22. see markus brunnermeier, the resilient society (2021). 2022] generation covid-19 long-haul 55 attention and productivity gaps but also raises awareness for problems arising in the new emerging democratization of healthcare information online with particular focus on privacy and discrimination concerns of vulnerable populations sharing information openly online. section 3.3 draws from historical examples of the past to outline crises as crucial turning points for system changes and argues that policymakers should pay particular attention to the disparate effect of covid-19 long-haul tails in a world, in which minimalism, rest, and recovery have become essential for moving forward. part 4 discusses science and policy implications before the article ends in part 5 with a conclusion. ii. covid-19 and its long-term impact a. covid-19 the new coronavirus (also referred to as “sars-cov-2,” or “covid-19”) is an infectious disease that was first diagnosed in wuhan, china, in december 2019.23 first in january of 2020, international entities, foremost the world health organization, were alarming about covid-19 and subsequently declared the state of emergency with international relevance. by march 2020, covid-19 was recognized as the outbreak of a global pandemic.24 as of the end of 2021, over 250 million infected cases are known and over 5 million covid-19 induced deaths have been recorded in over 220 countries and national entities in all world health organization territories.25 actual infection rates may be higher, adding from 5% to 30% more infected to the reported numbers.26 covid-19 causes blood vessel changes that affect people in different ways, ranging from no symptoms to mild cases and severe illness and death. symptoms may appear at different times, either immediately or – as most infected report – within several days. incubation time intervals range from 2-14 days or 4-6 days depending on covid-19 variants – but also some mild cases have been reported to cause health impairment a long time after the initial infection. some cases of infection turn out to be relatively mild but tend to exhibit often seemingly unrelated symptoms appearing months after the initial infection. these so-called covid-19 long hauler cases often show widespread and diffuse symptoms coming on and off in waves. to this day, the united states centers for disease control and prevention (“cdc”) continues to update the list of covid-19 induced symptoms and related 23. timeline: who’s covid-19 response, world health org., https://www.who.int/ emergencies/diseases/novel-coronavirus-2019/interactive-timeline [https://perma.cc/94w7-t34l] (last visited dec. 28, 2021). 24. rubin, supra note 8. 25. coronavirus cases, supra note 4. 26. severe undercounting of covid-19 cases in u.s., other countries estimated via model, sciencedaily (feb. 8, 2021), https://www.sciencedaily.com/releases/2021/02/210208142434.htm [https://perma.cc/4hjv-p8uq]. 56 indiana health law review [vol. 19:47 health complications as well as psychological impairments.27 the most common signs of a covid-19 infection are fever, dry cough, and tiredness. other symptoms often noticed include shortness of breath or difficulty breathing, muscle aches, chills, sore throat, running nose, headaches, and chest pain. additional covid-19 impairments include loss of taste or smell, congestion, nausea, vomiting diarrhea, confusion, sleepiness, insomnia, skin, gum, and tongue outbreaks.28 depending on age and pre-existing conditions, covid-19 can lead to acute complications such as organ failure, cytokine storms, blood clots, and septic shock.29 of the over 250 million covid-19 individuals reported to have been infected, 99.4% appeared to have had only mild conditions, and only 0.6% are/were considered seriously and/or critically ill.30 of the reported closed covid-19 infection cases so far, in 2% the covid-19 disease led to death, while 98% of the infected are considered to have recovered from acute symptoms.31 why any particular patient falls into either of these groups of immune responses to covid-19 is yet unclear, but certain disease trajectory propensities seem to depend on gender, age and pre-existing conditions. moreover, the viral load exposure to the virus and other infections influence the course of the disease alongside a range of genetic predispositions and environmental pre-covid episodes.32 the covid-19 fatality rate varies between 2.8% for male and 1.7% for female patients.33 as for the covid-19 fatality rate by comorbidity, pre-existing conditions increase the death rate to 10.5% across cases of cardiovascular diseases, 7.3% for diabetes, 6.3% for chronic respiratory diseases, 6% for hypertension, and 5.6% for cancer.34 underlying conditions and pre-existing health impairments – such as, for instance, diabetes, lung disease, cancer, immunodeficiency, heart diseases, hypertension, asthma, kidney disease, and gi/liver diseases – appear to play a major role in determining the outcome likelihoods of a covid-19 infection.35 nutrition and prevention influence the disease trajectory and sickness outcome, as do precautions and vigilance, such as being vaccinated against covid-19, targeted medication, not getting exposed to a high viral load, and avoiding 27. post-covid conditions: information for healthcare providers, ctrs. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/postcovid-conditions.html [https://perma.cc/un27-mk93] (last updated july 9, 2021). 28. symptoms of covid-19, ctrs. for disease control & prevention, https://www. cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html [https://perma.cc/z5l8-vbed] (last updated feb. 22, 2021). 29. id. 30. coronavirus cases, supra note 4. 31. id. 32. see abdul mannan baig, chronic covid syndrome: need for an appropriate medical terminology for long-covid and covid long-haulers, 93 j. med. virology 2555 (2021). 33. id. 34. interdisciplinary, multimedia conference, supra note 12. 35. coronavirus cases, supra note 4. 2022] generation covid-19 long-haul 57 repetitive exposure to the virus. in addition, the multiple covid variants existent by now impact the transmission likelihood and trajectory of the disease in symptoms and outcome differently.36 b. potential long-haul impact of covid-19 in about 10-50% of those symptomatically or asymptomatically previously infected with sars-cov-2, impairment continues long after the infection – in some cases even after having been tested negative for covid-19.37 long covid, also known as post-covid-19 syndrome, post-acute sequelae of covid-19 (“pasc”), chronic covid syndrome (ccs) and long-haul covid is a persisting convalescence period after a coronavirus disease 2019 infection.38 post-covid conditions comprise a wide range of new, returning and/or ongoing health problems that individuals can experience four or more weeks after the first infection.39 so-called covid-19 long haulers face impairment lasting more than 4-12 weeks after exposure to the virus. the degree, duration and frequency of impairment varies – some face constant issues, while it is estimated that around one third of covid long haulers face recurrent waves of symptoms after their initial infection.40 the range of long covid symptoms is wide and diffuse. survey data collected early on by a self-organized facebook long hauler group called survivor corps consisting of 1567 respondents struggling with long-term covid identified almost 100 long-haul effects that include fatigue (100% previouslycovid-infected survey takers reported it as a recurrent symptom), muscle or body aches (66.8%), shortness of breath or difficulty breathing (65.1%), difficulty concentrating or focusing (59%), inability to exercise or be active (58.5%), headache (57.6%), difficulty sleeping (49.9%), anxiety (47.6%), memory problems (45.6%) and dizziness (41.9%) among the top long-haul symptoms.41 follow-up studies revealed a cluster of symptoms ranging from chest pain and cough, dyspnea and cough, anxiety and tachycardia, abdominal pain and nausea as well as lower back pain or joint pain.42 the list of symptoms is still being updated while the cdc issued guidelines call for empathy with long haulers.43 36. id. 37. hart, supra note 9; searing, supra note 9. 38. baig, supra note 32; post-covid conditions, ctrs. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html [https://perma.cc/ 53d8-3g5h] (last visited aug. 21, 2021). 39. id. 40. harrison, supra note 8. 41. britt, supra note 8. 42. aislinn antrim, study: many long-haul covid-19 patients were asymptomatic during initial infection, pharmacy times (mar. 12, 2021), https://www.pharmacytimes.com/view/studym an y-lon g-h au l-cov id-19-patien ts-were-asymptomatic-during-in it ia lin fec t ion [https://perma.cc/x7yc-t4rg]. 43. post-covid conditions: information for healthcare providers, supra note 27; post58 indiana health law review [vol. 19:47 longer lasting covid-19 symptoms appear to come in waves, can be wideranging, and include – by now – over 200 different symptoms, such as cognitive dysfunction, numbness or tingling, loss of taste, smell and other senses like hearing and vision, muscle pain, tinnitus, heart rate and blood pressure issues, inflammation, joint pain, gastrointestinal discomfort, insomnia, depression and anxiety but also dermatological anomalies mainly in the gum, hands, fingers, feet and toes.44 from the physical but also the psychological standpoint, covid longhaul impairment is reported to be particularly challenging.45 the etiology of covid-19 long haulers currently appears to fall in three major – partially overlapping – groups of health problem clusters: (1) those with strong infection cases and long-term organ or tissue damage, (2) those with initially mild cases that develop waves of obscure symptoms that either resemble inflammatory and/or autoimmune diseases, and/or (3) neurological impairments that bleed into a traumatized psychological state.46 recovery remains unclear but for irreversible damage, such as scars on lungs, and damage to the heart tissue, transplantations appear the most promising longrun remedy. as for remainders of the virus and the immune system still working on clearing all body parts of the previous virus invasion, symptoms will likely be curable over time and may come and go, such as in herpes, shingles, ebola, or malaria. recurrent waves of weakness may persist for a long period of time for this cluster of covid long haulers but appear to have an overall upwards trajectory of recovery.47 for patients with overshooting immune activation, like lyme disease or virologically-triggered rheumatoid arthritis, immunosuppressants may aid but may create long-term disabling conditions if considering the relatively young age of covid long-haul onset. the demographic impact of long-haul covid appears to fall disproportionally heavily on 30-50 years young females with a mean age of around 42 years at the time of their initial infection.48 the average covid long haulers are in their late thirties and early forties, with females making up an covid conditions, supra note 38. 44. alicia ault, are there covid-19-related ‘long-haul’ skin issues?, dermatology news (jan. 28, 2021), https://www.mdedge.com/dermatology/article/235153/coronavirus-updates/ arethere-covid-19-related-long-haul-skin-issues [https://perma.cc/52eq-zuum]; kathleen doheny, neurological symptoms frequent in covid long-haulers, webmd (mar. 23, 2021), https://www. webmd.com/lung/news/20210323/neurologic-symptoms-frequent-covid-long-haul-partients [https://perma.cc/g9er-ws5h]. 45. damian mcnamara, 'long haul' covid recovery worse than cancer rehab for some, webmd (july 12, 2021), https://www.webmd.com/lung/news/20210712/long-haul-covid-recovery [https://perma.cc/w5g3-ezzd]. 46. julia m. puaschunder, generation post-covid-19: the time for anti-economics has come: health, minimalism and rest, scientia moralitas conf. proc. 1, 5 (2021). 47. see hannah e. davis et al., characterizing long covid in an international cohort: 7 months of symptoms and their impact, 38 eclinicalmedicine 1 (2021). 48. rubin, supra note 8. 2022] generation covid-19 long-haul 59 estimated 70-75%.49 most recently, emerging studies report that multi-organ functioning debilitation after covid-19 can also be prevalent in children and young, previously fully healthy and active adults.50 most recent preliminary research findings suggest that at least in some covid long haulers the immune system appears to develop macrophages with protein debris that – a while after the initial infection – start causing harm to the immune system by creating inflammation in different parts of the body that creates or further exacerbates chronic debilitation.51 ongoing research attributes an overshooting autoimmune response and/or early onset of a genetically-predisposed autoimmune disease as causing the disabled state of covd-19 long haulers.52 c. generation covid-19 long-haul a recent study of 6,500 covid long haulers estimated that 10-30% of all infected individuals have the potential to become long haulers suffering from lasting effects of a previous covid infection and continuous disability and/or waves of recurrent symptoms,53 which include fatigue, headaches and breathing problems as well as a set of debilitating memory fog and emotional distress.54 research estimates that from about 10% upwards to up to 50% of those exposed to covid-19 patients will become long haulers, and that 80% of the world population will be infected with covid at a certain point in their lives.55 consequently, the world faces a potential long hauler population ranging from over 600 million to more than three billion long haulers worldwide in the decades to come. by february 2021 the covid-19 pandemic had caused an estimated loss of over 20.5 million human life years globally.56 by november 2021 the estimated 49. id. 50. harrison, supra note 8. 51. drbeen medical lectures, supra note 10. 52. id.; yale study connects long covid with autoantibodies, yale sch. med. (jan 5, 2021), https://medicine.yale.edu/media-player/yale-study-connects-long-covid-with-autoantibodies/ [https://perma.cc/hgf3-kkpu]; see also eric y. wang et al., diverse functional autoantibodies in patients with covid-19, 595 nature 283 (2021). 53. hart, supra note 9. 54. rubin, supra note 8; press release, president joe biden, fact sheet: biden-harris administration marks anniversary of americans with disabilities act and announces resources to support individuals with long covid (july 26, 2021), https://www.whitehouse.gov/briefingroom/statements-releases/2021/07/26/fact-sheet-biden-harris-administration-marks-anniversary-ofamericans-with-disabilities-act-and-announces-resources-to-support-individuals-with-long-covid/ [https://perma.cc/j7q2-u9q5]; chelsea cirruzzo, long covid can be a disability, white house says, u.s. news (july 26, 2021), https://www.usnews.com/news/health-news/articles/2021-0726/long-covid-can-be-a-disability-biden-administration-says. 55. hart, supra note 9; searing, supra note 9. 56. see héctor pifarré i arolas et al., years of life lost to covid-19 in 81 countries, 11 nature sci. rep. 3504 (2021). 60 indiana health law review [vol. 19:47 lost years of life around the globe had risen to 28 million.57 with the potential for a growing body of long-term debilitation in covid-19, and with the lack of a complete cure and/or protection against covid-19 so far, but also the sobering recognition that only a bit over 50% of the world population has been vaccinated against the coronavirus and only 5% in low-income countries and breakthrough cases or cases of long haulers are reported despite being vaccinated leads to the projection that the coronavirus 2019 crisis will have a lasting socio-economic impact on contemporary humankind and generations to come.58 d. generation covid-19 great reset opportunity covid-19 accounts for the most unpredicted and widespread external shock for modern humankind. drastic downturns for trade, human mobility and international service industries demanded unprecedented governmental intervention.59 overall, the covid-19 global recession is estimated to be the deepest since world war ii, with the largest fraction of economies experiencing declines in per capita output since 1870.60 the economic external shock seems to have ended globalization and international exchange if considering the world bank expecting the sharpest decline in remittances in recent history.61 while the 57. andrew jeong, covid study finds some 28 million extra years of life lost in 2020, with u.s. male life expectancy badly hit, wash. post (nov. 4, 2021, 2:11 am), https://www. washingtonpost.com/health/2021/11/04/coronavirus-pandemic-global-years-lost-life/ [https://perma.cc/5dkq-fk6s]; see also nazrul islam et al., effects of covid-19 pandemic on life expectancy and premature mortality in 2020: time series analysis in 37 countries, 375 brit. med. j. 1 (2021). 58. un response to covid-19, united nations, https://www.un.org/en/coronavirus/unresponse [https://perma.cc/x3t8-bkj2] (last visited aug. 29, 2021); coronavirus (covid-19) vaccinations, our world data, https://ourworldindata.org/covid-vaccinations [https://perma.cc/ g78l-hjk5] (last visited aug. 29, 2021). 59. julia m. puaschunder et al., covid-19 shock: considerations on socio-technological, legal, corporate, economic and governance changes and trends, proc. 16th int’l rsch. ass’n for interdisc. stud. conf. on soc. sci. & human. 82, 86 (2020); see generally stefan gössling et al., pandemics, tourism and global change: a rapid assessment of covid-19, 29 j. sustainable tourism 1, 2 (2020); sachs et al., supra note 8; see also how covid-19 is changing the world: a statistical perspective, comm. for coordination stat. activities 1, 14-31 (2020) (demonstrating the economic decline in various industries); global economic prospects: global outlook, world bank grp. 3 (2021). the international monetary fund (“imf”) estimated a drastic drop in global gross domestic production from -3% in april, 2020, to -4.9% by june 2020. a crisis like no other, an uncertain recovery, supra note 18. 60. m. ayhan kose & naotaka sugawara, understanding the depth of the 2020 global recession in 5 charts, world bank (june 15, 2020), https://blogs.worldbank.org/opendata/ understanding-depth-2020-global-recession-5-charts [https://perma.cc/n8lg-5le4]. 61. press release, world bank, world bank predicts sharpest decline of remittances in recent history (apr. 22, 2020), https://www.worldbank.org/en/news/press-release/2020/04/22/ world-bank-predicts-sharpest-decline-of-remittances-in-recent-history [https://perma.cc/43m82022] generation covid-19 long-haul 61 recession did not last as long as originally expected and reverted to growth in 2021, it is still likely to have a persistent worldwide impact when considering the substantial quantitative easing and monetary control the saving of the global world economy has taken.62 the unprecedented size, scope and dimensions of covid-19 rescue and recovery plans have also sparked discourse about the potential negative consequences of inflation and urge to reflect on the disparate negative impacts on marginalized groups. the economic fallout63 is expected to bring about lasting fundamental changes for society.64 yet the crisis also holds enormous potential as governments around the globe have embarked on a course to avert the negative impetus of the covid-19 pandemic economic shock. these measures resulted in long-term international, governance and governmental changes funded by unprecedentedly large rescue packages and recovery aid.65 the short-term impact of covid-19 has triggered massive financial flows of economic rescue and governance recovery aid around the world already. coupled with behavioral changes and abrupt shifts in consumption patterns in addition to governmental legal and governance regulatory innovations, one starts imagining the once-in-a-lifetime potential of covid-19 for a lasting “reset” of the world.66 in the international arena, central banks of all major world economies and the european central bank coordinated to lower the price of usd liquidity swap line arrangements in order to foster the provision of global liquidity.67 the international monetary fund (“imf”) and the world bank68 issued economic vhu2]. 62. business cycle dating committee announcement july 19, 2021, nat’l bureau econ. rsch. (july 19, 2021), https://www.nber.org/news/business-cycle-dating-committee-announcementjuly-19-2021 [https://perma.cc/xl44-4tep] (finding the recession in the u.s. lasted only from february through april 2021); james k. jackson, et al., global economic effects of covid-19, cong. rsch. serv. 1, 30-31 (2021) (reviewing projections for growth in the major economies in 2021). 63. a crisis like no other, an uncertain recovery, supra note 18. 64. puaschunder & beerbaum, supra note 19. 65. cassim et al., supra note 20; press release, president joe biden, supra note 20. 66. adrian monck, the great reset: a unique twin summit to begin 2021, world econ. f. (june 3, 2020), https://www.weforum.org/press/2020/06/the-great-reset-a-unique-twin-summitto-begin-2021 [https://perma.cc/fb8k-l7dt]. 67. gabe alpert, international covid-19 stimulus and relief, investopedia, https://www. investopedia.com/government-stimulus-and-relief-efforts-to-fight-the-covid-19-crisis-5113980 [https://perma.cc/jk5z-fv8n] (last updated sept. 7, 2021); press release, eur. cent. bank, coordinated central bank action to enhance the provision of global us dollar liquidity (mar. 15, 2020), https://www.ecb.europa.eu/press/pr/date/2020/html/ecb.pr200315~1fab6a9f1f. sv.html [https://perma.cc/l4kl-vv4c]; press release, bd. governors fed. rsrv. sys., federal reserve announces the establishment of temporary u.s. dollar liquidity arrangements with other central banks (mar. 19, 2020), https://www.federalreserve.gov/newsevents/pressreleases/monetary 20200319b.htm [https://perma.cc/msk9-ldxr]. 68. alpert, supra note 67; the imf's response to covid-19, int’l monetary fund, 62 indiana health law review [vol. 19:47 stimulus and relief efforts in the range of around 260 billion u.s. dollars, with the majority of relief aid being distributed in the developing world.69 as of may 2021, all major economies responded to the economic fallout of covid-19 in financial terms. in light of the ongoing covid-19 crisis, governments around the world have rolled out economic assistance packages or recovery releases that by mid-2020 already amount to a total of over ten trillion u.s. dollars.70 given the long-term impetus and the recurrent waves of covid outbreaks still ongoing, there is a continuous prospect of renewal and further expansion of economic rescue and recovery aid. across countries, economic stimulus responses to the covid-19 crisis vastly outsize those to the 2008 financial crisis.71 the qualitative and quantitative stimulus, rescue and recovery aid packages have surpassed all other programs of this type in human history.72 the cost of saving the global economy is estimated to have been 834 million u.s. dollars per hour for eighteen months, including almost four trillion rescue funds spent by the united states federal reserve alone.73 economic covid-19 stimulus and relief efforts mainly comprise international fiscal and monetary stimulus and relief efforts but also direct rescue bailout packages. these are often coupled with publicly administered healthcare and labor regulations, such as kurzarbeit schemes limiting the number of work hours per worker in order to keep workers employed.74 https://www.imf.org/en/about/faq/imf-response-to-covid-19 (last visited may 13, 2020); press release, world bank, world bank group announces up to $12 billion immediate support for covid-19 country response (mar. 3, 2020), https://www.worldbank.org/en/news/press-release/ 2020/03/03/world-bank-group-announces-up-to-12-billion-immediate-support-for-covid-19country-response#:~:text=washington%2c%20march%203%2c%202020%20%e2%80%94, impacts%20of%20the%20global%20outbreak [https://perma.cc/2dph-er7w]; press release, world bank, world bank group increases covid-19 response to $14 billion to help sustain economies, protect jobs (mar. 17, 2020), https://www.worldbank.org/en/news/press-release/2020/ 03/17/world-bank-group-increases-covid-19-response-to-14-billion-to-help-sustain-economiesprotect-jobs [https://perma.cc/gqw7-2u3d]. 69. alpert, supra note 67; press release, world bank, world bank group: 100 countries get support in response to covid-19 (coronavirus) (may 19, 2020), https://www.worldbank.org/en/ news/press-release/2020/05/19/world-bank-group-100-countries-get-support-in-response-to-covid19-coronavirus [https://perma.cc/fg8j-mq99]. 70. cassim et al., supra note 20; press release, president joe biden, supra note 20. 71. id. 72. alpert, supra note 67. 73. lynn thomasson & james hirai, the cost of saving global economy: $834 million an hour for 18 months, bus. standard (aug. 21, 2021), https://www.business-standard.com/article/ international/the-cost-of-saving-global-economy-834-million-an-hour-for-18-months121082100048_1.html [https://perma.cc/7w2a-mwgm]. 74. see jackson et al., supra note 62, at 25-27; lora jones et al., coronavirus: how the pandemic has changed the world economy, bbc news (jan. 24, 2021), https://www.bbc.com/ news/business-51706225 [https://perma.cc/nqe3-6jdw]; the peril and the promise, economist 2022] generation covid-19 long-haul 63 the size, scope and dimension of covid-19 rescue and recovery plans account for the historically largest concerted action to avert the negative economic fallout to a worldwide external economic shock. in confronting the crisis and evaluating international and governmental rescue efforts, the size of rescue and recovery aid has gained widespread attention, foremost because of fear of inflationary pressure.75 these unprecedentedly-large amounts of governmental stimulus, economic bailout and rescue funds hold opportunity to finance a great reset.76 in strategically setting economic incentives and stimulating societal advancement in the post-covid era, society is hoped to emerge stronger out of a crisis.77 the remainder of the article will focus on three speculative trends in the wake of the covid-19 crisis with particular attention to covid long haulers and potential legal and public policy implications. the socio-economic trends of our currently forming generation covid-19 long-haul are discussed in the following sections to enhance society’s potential for building resilience vigilantly. iii. covid-19 long-haul trends a. governance and political economy of deurbanization the covid-19 crisis is the most unexpected external shock of our times. starting from the end of 2019, the novel coronavirus caused a dramatic downturn for consumption, trade, human mobility and international service industries.78 (oct. 8, 2020), https://www.economist.com/special-report/2020/10/08/the-peril-and-the-promise [https://perma.cc/9gyg-3zru]; the pandemic has caused the world’s economies to diverge, economist (oct. 8, 2020), https://www.economist.com/leaders/2020/10/08/the-pandemic-hascaused-the-worlds-economies-to-diverge [https://perma.cc/qn7z-l3kv]; economy, eurostat, https://ec.europa.eu/eurostat/web/covid-19/economy [https://perma.cc/sdw7-kbtj] (last visited july 28, 2020); see also ken mayhew & paul anand, covid-19 and the uk labour market, 36 oxford rev. econ. pol’y s215, s217-21 (2020) (surveying furlough schemes in the uk and germany). 75. see brunnermeier, supra note 22. the quantitative dimensions and largesse of governmental financialization of aid has led to star economists lawrence summers and paul krugman arguing over the right size of the governmental intervention in economic stimulus. summers points at the sheer amount of stimulus that could set off inflationary pressures – a concern shared by other economists, such as olivier blanchard, a macroeconomist expert on inflationary pressure. see, e.g., olivier blanchard, in defense of concerns over the $1.9 trillion relief plan, peterson inst. for int’l econ. (feb. 18, 2021, 10:15 am), https://www.piie.com/blogs/realtime-economic-issueswatch/defense-concerns-over-19-trillion-relief-plan [https://perma.cc/8deg-j42u] (defending concerns over the $1.9 trillion relief plan). 76. see, e.g., the great reset, world econ. f. (sept. 24, 2020), https://www.weforum.org/ great-reset/ [https://perma.cc/7mhh-das7]. 77. brunnermeier, supra note 22. 78. puaschunder et al., supra note 59, at 86; see generally gössling et al., supra note 59, at 2; catherine tymkiw, how covid-19 changed our saving and spending habits, investopedia, 64 indiana health law review [vol. 19:47 from april 2020, more than half of the world’s population faced some sort of lockdown and/or consumption constraints and economic shortages, which disrupted economic productivity substantially.79 constraints on human social interaction in all major world economies coupled with a halt of human transport and trade shortages around the globe spilled over into an unprecedented international economic decline.80 the lockdowns led to a slump in general consumption and reduced trade by an estimated 10%.81 during the first two quarters of 2020, global fdis plummeted by 49%, and were even suppressed by around 75% in the developed world.82 the global economy declined by around 3-5% of the general world economic output in 2020, six times the economic magnitude of the 2008-09 world recession.83 the imf estimates that the world economy, as measured by real gross domestic product (“gdp”), shrank by as much as 3.5% in 2020.84 rising poverty levels put an additional 150 million children at risk worldwide.85 the covid-19 global recession is believed to be the deepest since world war ii, with the largest fraction of economies experiencing declines in per capita output since 1870.86 the economic external shock seems to end globalization and to severely limit international exchange when considering that the world bank is expecting the sharpest decline in remittances in recent history.87 the external shock to the world economy, international relations and our all daily lives accounts for the most disruptive lifestyle change factor of modernity.88 never before in the history of economics has the entire world economy contracted by 20% in a matter of weeks and 95% of the world’s economies were suffering.89 across the world hundreds of millions lost their employment.90 long after the https://www.investopedia.com/how-covid-19-changed-our-saving-and-spending-habits-5184327 [https://perma.cc/3t5d-6mps] (last updated sept. 28, 2021). 79. policy responses to covid-19, int’l monetary fund, https://www.imf.org/en/topics/ imf-and-covid19/policy-responses-to-covid-19 (last updated july 2, 2021). 80. see, e.g., sachs et al., supra note 8, at 455; see also how covid-19 is changing the world, supra note 59, at 14-31. 81. changing places, supra note 11. 82. investment trends monitor, united nations conf. on trade & dev. 1, 1 (2020). 83. global economic prospects, supra note 59, at 3. the international monetary fund (imf) outlined a decline in global gross domestic product of -4.9% in june 2020. the imf's response to covid-19, supra note 68. 84. alpert, supra note 67. 85. press release, united nations child. fund, 150 million additional children plunged into poverty due to covid-19, unicef, save the children say (sept. 16, 2020), https://www.unicef. org/press-releases/150-million-additional-children-plunged-poverty-due-covid-19-unicef-savechildren [https://perma.cc/72qs-qd8f]. 86. kose & sugawara, supra note 60. 87. global economic prospects, supra note 59. 88. see adam tooze, shutdown: how covid shook the world’s economy (2021). 89. id. 90. id. 2022] generation covid-19 long-haul 65 onset of crises, the world faces the threat of a majority of the population requiring long-term health, well-being and economic recovery aid.91 all these measures resemble the onset of a lasting economic crisis92 that precipitates fundamental changes in society.93 governments around the globe have set out on a course to avert the negative impetus of the covid-19 pandemic economic shock.94 1. rising inequality the union bank of switzerland (“ubs”) addresses the covid-19 pandemic shock as the biggest economic disparity between modern world economies in at least forty years opened up in the aftermath of the covid outbreak.95 covid-19 creates new but also exacerbates already existing inequality.96 the pandemic heightened economic disparity between countries, sectors, and societal groups. existing inequalities became more accentuated in regards to healthcare and wellbeing but also digitalization productivity.97 covid-19 created enormous health and security threats but also economic costs. at the same time, every situation brings market opportunities.98 industries such as hygiene, medical care, pharmaceutical and medical supply providers, and nutrition and chronic disease specialists actually profited from covid-19 and its long-term impetus.99 in that sense, the covid-19 external shock is 91. id. 92. a crisis like no other, an uncertain recovery, supra note 18. 93. puaschunder & beerbaum, supra note 19. 94. cassim et al., supra note 20; press release, president joe biden, supra note 20. 95. changing places, supra note 11; the pandemic has caused the world’s economies to diverge, supra note 74; the peril and the promise, supra note 74. 96. puaschunder et al., supra note 59; gössling et al., supra note 59, at 1. 97. puaschunder & beerbaum, supra note 19. 98. see julia m. puaschunder et al., alleviating an unequal covid-19 world: globally digital and productively healthy, proc. unequal world conf.: on hum. dev. 1 (2020). 99. sharon lerner, big pharma prepares to profit from the coronavirus, intercept (mar. 13, 2020, 1:46 pm), https://theintercept.com/2020/03/13/big-pharma-drug-pricing-coronavirusprofits [https://perma.cc/nlq3-zfz9]; gaurav agrawal et al., winning against covid-19: the implications for biopharma, mckinsey & co. (apr. 15, 2020), https://www.mckinsey.com/ industries/pharmaceuticals-and-medical-products/our-insights/winning-against-covid-19-theimplications-for-biopharma#the-implications-for-biopharma [https://perma.cc/a2n4-hq5n]; monck, supra note 66; neeraj kumar & danny haydon, industries most and least impacted by covid-19 from a probability of default perspective – march 2020 update, s&p glob. (apr. 7, 2020), https://www.spglobal.com/marketintelligence/en/news-insights/blog/industries-most-andleast-impacted-by-covid-19-from-a-probability-of-default-perspective-march-2020-update [https://perma.cc/umr2-sppb]; darren dodd, covid-19’s corporate casualties, fin. times (june 22, 2020), https://www.ft.com/content/eb6efc36-bf99-4086-a98a-7d121738b4b4 [https:// perma.cc/k925-fupw; jason aravanis, five industries set to outperform due to covid-19, ibisworld (apr. 7, 2020), https://www.ibisworld.com/industry-insider/coronavirus-insights/fiveindustries-set-to-outperform-due-to-covid-19/ [https://perma.cc/lv6m-phm2]; rohit arora, which 66 indiana health law review [vol. 19:47 fundamentally different from previous major recessions inherent to the economic system, which were primarily caused by financial liquidity constraints within the banking sector.100 during the covid-19 fallout, financial markets surprisingly performed relatively well when being compared to real economy constraints. a rather unexpected effect during the recovery from the first economic shock was the blatantly unequal performance of financial markets compared to actual economic performance. this disjunction between financial markets on the one hand, and real economic activities on the other hand, already emerged as a trend in the 1990s, in the united states in particular in the aftermath of financial market deregulation.101 financial performance began to diverge massively from the real economy in 2008/09, but the greatest divergence so far was brought about by the coronavirus crisis, which widened the gap between top performance of financial markets and negative socio-economic fallout in the real economy.102 the finance-real economy gap widened as the finance world could reallocate funds quickly, while the real economy saw liquidity crunches in the wake of lockdowns and consumption drops resulting in closures and bankruptcies echoing in bottlenecks for private households. since the onset of a lasting crisis, the novel coronavirus caused a dramatic downturn for general consumption and service sector industries.103 mobility, trade and tourism including gastronomy plummeted, even though these sectors usually persist during system-inherent downturns as the freshly laid off typically spend novel-won-leisure time on service sector goods, enjoying vacations, lifestyle entertainment, put-off healthcare and well-being.104 yet in the case of the coronavirus crisis, the lockdowns and social distancing put a halt to leisure consumption. in the real economy, covid-19 caused “social volatility” – a collectively companies did well during the coronavirus pandemic?, forbes (june 30, 2020, 8:10 am), https://www.forbes.com/sites/rohitarora/2020/06/30/which-companies-did-well-during-thecoronavirus-pandemic/#17fe6c9b7409 [https://perma.cc/ack6-7ez8]. 100. database on covid-19 trade flows and policies, world bank, https://www. worldbank.org/en/data/interactive/2020/04/02/database-on-coronavirus-covid-19-trade-flows-andpolicies [https://perma.cc/473g-uymr] (last visited july 28, 2020); global economic prospects, supra note 59. 101. see generally branko milanovic, global inequality: a new approach for the age of globalization (2016); thomas piketty, capital in the twenty-first century (arthur goldhammer trans., 2014). see also raj chetty & markus brunnermeier, raj chetty on the economic impacts of covid-19: real-time evidence from private sector data, princeton univ. bendheim ctr. for fin. (june 17, 2020, 12:30 pm), https://bcf.princeton.edu/events/raj-chetty-onthe-economic-impacts-of-covid-19-real-t ime-evidence-from-private-sector-data/ [https://perma.cc/yre3-jas3]. 102. changing places, supra note 11; the pandemic has caused the world’s economies to diverge, supra note 74; the peril and the promise, supra note 74. 103. tymkiw, supra note 78. 104. puaschunder et al., supra note 59, at 86; see generally gössling et al., supra note 59, at 2. 2022] generation covid-19 long-haul 67 depressed mood that largely cut consumption and opportunistic spirit. social distancing led to temporary business closures accompanied by massive layoffs – particularly in the service sector, gastronomy, and tourism industries. unemployment increased up to 70% in the mid-career segment of these industries.105 forty million european workers were switched to short-time schedules to keep them at work.106 this so-called kurzarbeit labor protection plan encourages firms to reduce work hours instead of laying off or furloughing workers.107 the oecd and bloomberg estimate that 19% of workers were furloughed in the uk, 23% in germany, and 41% in france.108 in more marketoriented territories, the impact was more severe.109 for example, in great britain unemployment jumped to 5.4%, and in the united states to 8.9%.110 coupled with individual households being under lockdown, consumption dropped by 46% in china, 97% in germany, and 20% in the united states, as well as 78% in the uk in the early months of the pandemic.111 the financial world is flexible to exchange covid-affected industries – such as petroleum, public transport, and the aviation and leisure sectors, such as international hospitality and gastronomy – for covid-winning industries such as pharmaceuticals and emergency care, digital communication, fintech, online retail, used automotives, and interior design with an emphasis on healthy living.112 to a certain extent, this happens automatically, in particular when badly performing firms drop out of an index (and hence out of index funds) but also in well-maintained sophisticated portfolios. moreover, portfolio managers can diversify risks ex ante, which is why losses from badly performing firms in certain industries will be balanced by gains in winning industries that grew during the pandemic.113 on the individual firm level, financial managers can benefit from losses in firms by shorting their stock and hedging based on derivatives to avoid exposure to possible declines. for the finance world, it is thus possible to turn losses in the real economy into financial gains. finance professionals were in a better position to recover once the crisis hit, and certain consumption propensities became apparent. by contrast, firms operating in the real economy typically need time to adapt to changing conditions as they have long-term investments and obligations that can only be adjusted at a relatively higher cost. just imagine the 105. the peril and the promise, supra note 74. 106. the pandemic has caused the world’s economies to diverge, supra note 74. 107. jones et al., supra note 74 (graphically showing data provided by the international monetary fund). 108. id. (showing data provided by the oecd); see also mayhew & anand, supra note 74 (surveying furlough schemes in the united kingdom and germany). 109. see economy, supra note 74 (tracking several indicia of economic health for several european countries as against the eu as a whole). 110. jones et al., supra note 74; see also covid-19: measuring unemployment, cong. rsch. serv. 1 (2020). 111. jones et al., supra note 74. 112. economics in the time of covid-19, supra note 1. 113. lerner, supra note 99; agrawal et al., supra note 99. 68 indiana health law review [vol. 19:47 difference in capital mobility and liquidity constraints between portfolio investments on the one hand and a small business such as a restaurant, which will have a long-term lease, employees with specific on-the-job training and potentially a set of complex long-term order contracts. different than during the 2008/09 world financial recession, which came from system-inherent finance market constraints, during the covid-19 external shock there was a rapid recovery of financial markets, funds and investment banks. for instance, the financial times stock exchange index, dow jones industrial average, and nikkei plummeted in the first quarter of 2020 drastically.114 at the same time, deutsche bank saw rising earnings after the onset of the coronavirus crisis in europe of even up to 43% or 2.4 billion euros in its investment branch in the third quarter of 2020.115 the standards and poor’s (“s&p”) 500 recovered half of its pre-covid value in only three months after the crisis hit new york and regained pre-pandemic levels by june 2020 to reach all-time highs from august 2020 and is exhibiting continuously rising trends.116 digitalized cryptocurrencies and crowdfunding now also allow investors to further benefit from a crisis of social distancing, bottlenecks, and trade frictions. in all these features, the strong contrasts between covid-19 winners and losers widened an already existing gap between financial markets and the real economy, which will likely exacerbate the longer the covid-19 crisis continues. not only will differences in the infection risk and the possibility to prevent disease and/or a mild sickness between the two sectors determine continuously rising levels of inequality. in addition, the number of individuals suffering from covid long-haul symptoms and their belonging to particular social strata will further exacerbate inequality. deep divides also opened between strongly positive financial market developments and the negative socio-economic fallout performance and increase in harmful lifestyle propensities of the real world. the emotional impact will likely differ depending on whether one can experience the crisis as an opportunity to garner financial gains, or whether one faces liquidity constraints and an increased risk of long-term debilitation. the economic burden 114. id. 115. deutsche bank surprises with high profit, dw (oct. 28, 2020), https://www.dw.com/ de/deutsche-bank-%c3%bcberrascht-mit-hohem-gewinn/a-55417971 [https://perma.cc/9fqsbhts]; elliot smith, deutsche bank swings back to profit in third quarter, beats expectations, cnbc (oct. 28, 2020), https://www.cnbc.com/2020/10/28/deutsche-bank-q3-earnings-2020.html [https://perma.cc/qg3f-yvca]. 116. fundamental chart, ycharts, https://ycharts.com/charts/fundamental_chart/#/? annotations=%5espxtr:::level::max:true,min:true&annualizedreturns=false&calcs=id:level,i nclude:true,,&charttype=interactive&chartview=&correlations=&dateselection=range&displa ydaterange=false&displayticker=false&enddate=06%2f24%2f2020&format=real&legendo nchart=false&note=&partner=basic_2000&quotelegend=false&recessions=false&scaletype=l inear&securities=id:%5espxtr,include:true,,&securitygroup=&securitylistname=&securityli stsecurityid=&source=false&splittype=single&startdate=03%2f01%2f2020&title=&units=fa lse&usecustomcolors&useestimates=false&zoom=custom [https://perma.cc/gcs3-tcm5] (last visited apr. 10, 2021). 2022] generation covid-19 long-haul 69 of long-haul covid may also fall disproportionally heavily on certain countries, and the means to fund recovery and disability payments to long haulers will determine the economic productivity of nations, social classes, and individual household members. in addition to between-country gaps and industry inequality in recovery from the crisis, covid-19 will likely affect power dynamics between employers and employees in light of long-term covid disability and debilitation. when going back in the history of humankind, the 14th century black death great plague caused about one third of the known population to decease. previous pandemics already created labor shortages and drivers of mechanization to replace human labor power. scarce labor increases the bargaining power of workers, but also sets trends to protect human health and replace human capital by mechanization into motion.117 labor relations and political dynamics between employers and employees may also shift because of long haulers’ relation to work. the longer people will be sickened by the virus or experience debilitation after an infection, the more consistently they will avoid contagion risks, for example working in an office with multiple people. the scarcer productive labor power will become, the more likely we will see an appreciation for a healthy productive environment. professions with less infection risk will draw those entering the labor force for the first time. imagine the tough decision to become a nurse or doctor, and contrast this with training to become a lawyer or it expert with the ability to work remotely from home. covid-19 and the fact that young individuals can end up with a lifetime of debilitation even after mild infections at a young age may alter students’ professional preferences and career choices. 2. deurbanization since the onset of the covid-19 pandemic, a deurbanization trend has evolved. a massive flow of people moved from large metropolitan areas to more rural spaces to socially distance and enjoy nature while being productive online.118 covid-19 has triggered the strongest move toward deurbanization in the united states in modern times, which applies both to private sector industries and families.119 given the contagion risk in crowded cities and the technological 117. nikolaus piper, the economy of death, süddeutsche zeitung (apr. 10, 2020, 6:51 pm), https://www.sueddeutsche.de/wirtschaft/pest-coronavirus-wirtschaft-1.4873813 [https:// perma.cc/2kcp-qs4e]. 118. dean donovan, deurbanization rising: covid-19, remote work and electric aviation will reshape living patterns, forbes (nov. 9, 2020), https://www.forbes.com/sites/deandonovan/ 2020/11/09/deurbanization-rising-covid-19-remote-work-and-electric-aviation-will-reshape-livingpatterns/?sh=5e4b53a55e1d [https://perma.cc/2k8q-9akp]; jonathan levin & claire ballentine, cathie wood’s new york exit spotlights overlooked florida region, bnn bloomberg (oct. 7, 2021), https://origin.bnn.ca/cathie-wood-s-new-york-exit-spotlights-overlooked-florida-region1.1663136 [https://perma.cc/w8h7-uymy. 119. see edward glaeser & david cutler, survival of the city: living and thriving in an age of isolation (2021). 70 indiana health law review [vol. 19:47 challenges of air purification in city skyscrapers with closed ventilation and elevators, covid-19 precipitated an outflux of corporate headquarters to the suburbs while granting employees the option to work remotely.120 the longer covid rages, the riskier international supply chains will be reshored, and the more will corporate headquarters be moving away from metropolitan areas.121 while cities are still seen as disadvantaged in controlling the spread of the disease, retail increasingly shifted online to lower the fixed cost of real estate and to mitigate health risks.122 demand for personal cars and bikes 120. somik lall & sameh wahba, cities, crowding, and the coronavirus: predicting contagion risk hotspots, world bank (apr. 23, 2020), https://blogs.worldbank.org/ sustainablecities/cities-crowding-and-coronavirus-predicting-contagion-risk-hotspots [https://perma.cc/vc2p-x34s]; andrew marquardt, we’re finally getting a glimpse of what the covid-safe skyscraper will look like, fortune (feb. 21, 2021, 6:00 pm), https://fortune.com/ 2021/02/21/covid-safe-offices-buildings-skyscrapers/ [https://perma.cc/a5rx-wrdj]; ryan ori, worries about covid-19 spreading through the vents send chicago building owners in search of cleaner air. ‘you can’t put a force field around your property’, chi. trib. (july 27, 2020), https://www.chicagotribune.com/columns/ryan-ori/ct-biz-real-estate-air-quality-coronavirus-ryanori-20200723-sud25stgvrfk5i5x6tkfqm2zkm-story.html [https://perma.cc/ez48-sgw2]; sasha wedekind, covid-19 catapults indoor air quality to top of the list, forbes (june 10, 2021), https://www.forbes.com/sites/pikeresearch/2020/06/10/covid-19-catapults-indoor-air-quality-to-topof-the-list/?sh=151daf5e52cd [https://perma.cc/xq5t-ynjb]; 35.9 million americans have moved. will offices move too?, uber, https://www.uber.com/blog/americans-business-officesmoving/ [https://perma.cc/8pru-ctbz] (last visited sept. 7, 2021); richard florida, the uncertain future of corporate hqs, harv. bus. rev. (sept. 18, 2020), https://hbr.org/2020/09/ the-uncertain-future-of-corporate-hqs [https://perma.cc/5947-27dd]; states and cities you should consider relocating your office to post covid-19, precision glob. consulting, https:// pgcgroup.com/blog/states-and-cities-you-should-you-consider-relocating-your-office-to-post-covid19 [https://perma.cc/nm7q-qrfr] (last visited sept. 7, 2021). 121. tony uphoff, 3 underreported trends that will accelerate reshoring, forbes (aug. 24, 2020), https://www.forbes.com/sites/tonyuphoff/2020/08/24/3-underreported-trends-that-willaccelerate-reshoring/#32ee7fe6668e [https://perma.cc/rw5r-2yv2]. 122. lall & wahba, supra note 120; marquardt, supra note 120; ori, supra note 120; wedekind, supra note 120; joe mcdonald, companies prodded to rely less on china, but few respond, ap news (june 29, 2020), https://apnews.com/bc9f37e67745c046563234d1d2e3fe01 [https://perma.cc/uy3b-u5mz]; shinzo abe, prime minister of japan, statement at council on investments for the future (mar. 5, 2020), https://japan.kantei.go.jp/98_abe/actions/202003/_ 00009.html [https://perma.cc/bhs4-65kx]; eu trade chief urges for more diverse supply chains after crisis, u.s. news (apr. 16, 2020), https://money.usnews.com/investing/news/articles/ 2020-04-16/eu-trade-chief-urges-for-more-diverse-supply-chains-after-crisis; see also vasileios theodeosopoulos, the geopolitics of supply: towards a new eu approach to the security of supply of critical raw materials?, inst. for eur. stud. 1 (2020); robert e. lighthizer, the era of offshoring u.s. jobs is over, n.y. times, (may 11, 2020), https://www.nytimes.com/2020/05/ 11/opinion/coronavirus-jobs-offshoring.html [https://perma.cc/k4fu-hcc8]; andrea shalal et al., u.s. mulls paying companies, tax breaks to pull supply chains from china, reuters (may 18, 2020, 12:03 am), https://www.reuters.com/article/us-usa-china-supply-chains/u-s-mulls-paying2022] generation covid-19 long-haul 71 increased, with the average used car price in june 2021 rising 32.7% compared to 2020.123 art and culture events were outsourced to more rural communities. art was re-curated for socially distanced performances, or even staged in newly emerging virtual luxury worlds.124 gastronomy temporarily shifted toward ordering in and shared virtual eating experiences.125 the sharing economy started to offer workspace closer to nature. covid-19 and the potential long-term negative impetus of a virus infection have not only changed our perception of closeness and close contact with others in dense urban areas, but it has also revolutionized interior design in offices with glass and plastic protection. the trend toward deurbanization is not only fueled by fears of infection in dense areas, but also by cutting on persistently rising living expenses in cities. inflationary pressure appears to rise disproportionally in metropolitan areas as housing and other unavoidable costs increase.126 the so-called “doughnut effect” captures the tendency of urban population moving from large metropolitan areas to the suburbs or even the countryside.127 home ownership booms in less densely populated areas – like arizona, texas, or florida – reflect the peoples’ preference companies-tax-breaks-to-pull-supply-chains-from-china-iduskbn22u0fh [https:// perma.cc/ 9k5d-8m6u]; geoffrey gertz, how to deglobalize, foreign pol’y (july 24, 2020, 4:19 pm), https://foreignpolicy.com/2020/07/24/how-to-deglobalize [https://perma.cc/bvw9-64q2]; the steam has gone out of globalisation, economist (jan. 24, 2019), https://www.economist. com/leaders/2019/01/24/the-steam-has-gone-out-of-globalisation [https://perma.cc/a6tj-lf9e]; multinational companies are adjusting to shorter supply chains, economist (july 11, 2019), https://www.economist.com/special-report/2019/07/11/multinational-companies-are-adjusting-toshorter-supply-chains [https://perma.cc/8ffw-vpha]. 123. mark vaughn, used car prices are going nuts! here are 10 of the biggest price jumps, autoweek (july 30, 2021), https://www.autoweek.com/news/g37149329/used-car-prices-biggestincreases/ [https://perma.cc/3ave-hsqa]; joe mcdonald, companies prodded to rely less on china, but few respond, ap news (june 29, 2020), https://apnews.com/bc9f37e67745c04656 3234d1d2e3fe01 [https://perma.cc/ff2z-evu7]; abe, supra note 122; eu trade chief urges for more diverse supply chains after crisis, supra note 122; theodeosopoulos, supra note 122. 124. see culture shock: covid-19 and the cultural and creative sectors, org. for econ. coop. & dev. 1 (2020); vanessa thorpe, covid-19 forces uk arts to seek virtual venues and online audiences, guardian (mar. 22, 2020), https://www.theguardian.com/culture/2020/mar/22/ cov id-1 9 -forces -a r t s -v ir t ual-venues-on lin e -au dien ces -cu ltu t a ll i f e -sh u tdow n [https://perma.cc/6nbq-u4ar]; laura feinstein, 'beginning of a new era': how culture went virtual in the face of crisis, guardian (apr. 8, 2021), https://www.theguardian.com/culture/ 2020/apr/08/art-virtual-reality-coronavirus-vr [https://perma.cc/r52g-bsxd]. 125. covid-19 era serves up big changes for u.s. restaurants, morgan stanley (july 17, 2020), https://www.morganstanley.com/ideas/coronavirus-restaurant-trends [https://perma.cc/ t7wl-cdpn]. 126. julia margarete puaschunder, supra note 17. 127. arjun ramani & nicholas bloom, the doughnut effect of covid-19 on cities, vox eu (jan. 28, 2021), https://voxeu.org/article/doughnut-effect-covid-19-cities [https://perma.cc/ df9m-52zb]. 72 indiana health law review [vol. 19:47 to escape cities.128 with the biden-harris administration’s decision to recognize long-haul covid as a disability, the general public has become more aware of the longterm impact of a covid infection.129 as long as covid remains a risk and the road to recovery from a long-haul infection looms large, corporations will have to offer options to work from home to retain a productive workforce. fearing litigation risk and public pressure, firms will likely be reluctant to force their employees to remain at a desk in a corporate headquarter housed in a congested power city that remains a hotbed of disease as travelers from around the world keep flying in and out. the doughnut effect is believed to be a lasting trend due to remote work conditions and social distancing preferences.130 deurbanization has already affected market equilibria. for example, the price of used cars rose over the course of the pandemic due to a higher demand in suburban areas and uncertainty about how long people will stay away from large cities.131 supply chain shortages of new cars from international markets, such as asia, contributed to price increases in used vehicles.132 within cities, this massive relocation trend first will continue to drive inequality. relocation quickly to a more pleasant environment and the flexibility to work online appear as prerogatives of the rich, while those left in metropolitan areas are often unable to afford a second country residence. this is true even more so where, for example, unskilled service workers in metropolitan areas are dependent on consumption by the wealthy.133 john maynard keynes’ multiplier effect, which is in this case based on the rich spending money that trickles down to other layers of the economy and society, has been shifting from the city to the suburbs.134 in a longer time perspective, however, deurbanization also raises the hope to alleviate social upward mobility inequality, which appears to be more strongly accentuated in cities. leaving metropolitan areas, in which density and size are 128. nicole friedman, the pandemic ignited a housing boom: but it’s different from the last one, wall st. j. (mar. 15, 2021, 12:09 pm), https://www.wsj.com/articles/the-pandemicignited-a-housing-boombut-its-different-from-the-last-one-11615824558 [https://perma.cc/rtf9nds7]; jeff ostrowski, 5 most and least popular states for americans who moved during covid, bankrate (feb. 12, 2021), https://www.bankrate.com/real-estate/states-growing-mostduring-pandemic/ [https://perma.cc/9tta-b4zs]. 129. rubin, supra note 8; press release, president joe biden, supra note 54; cirruzzo, supra note 54. 130. ramani & bloom, supra note 127. 131. vaughn, supra note 123. 132. ramani & bloom, supra note 127; mcdonald, supra note 122; abe, supra note 122; eu trade chief urges for more diverse supply chains after crisis, supra note 122. 133. princeton bendheim center for finance, markus brunnermeier on covid-19 economic lessons, youtube (dec. 17, 2020), https://www.youtube.com/watch?v=-ubv9vqnfz8 [https:// perma.cc/nby5-cx4j]. 134. john maynard keynes, the general theory of employment, interest, and money (1936). 2022] generation covid-19 long-haul 73 both negatively associated with performance on upward social mobility, may alleviate this effect within society.135 urban density and proximity of city center is negatively correlated with social upward mobility. moving to urban areas may thus help lower generational inequality.136 3. ecowellness in agrohoods in the suburbs or more rural areas, we can observe an ongoing trend to what can be called “ecowellness.”137 pre-existing prevalence, such as obesity and diabetes, as well as the immune system influence the covid disease trajectory. preventive care and whole-rounded lifestyles in harmony with nature thus have gained unprecedented momentum in the wake of covid-19.138 ecowellness sustainable lifestyle innovations concern health and well-being in relation to natural ecological limits.139 agrior agrohoods form in neighborhoods that try to live in harmony with each other and the natural surroundings while also celebrating cultural heritage.140 the remote workforce now builds wellness cocoons that celebrate healthy living embedded in a supportive community and in harmony with nature.141 long covid will drive a search for simplicity. long haulers appear to have an appreciation for minimalistic stimulation at home and live in harmony with nature. people ordering in spend more time at home during lockdowns. in suburbs, home cooking and minimalism have become covid long haul trends. exhausted long-term sufferers are trained to budget their cognitive resources wisely throughout the day and eliminate unnecessary cognitive and harmful influences. the longer covid exists and the more people will become affected, the less complex the working and daily world will have to become. in the private spaces, long haulers are likely prone to eliminate unnecessary items that clog their personal spaces, in which they will likely spend more time during recovery. within their living spaces, covid long haulers will also likely feel close to nature. already now, biophilic architecture that resembles the natural environment at home is booming.142 the fashion world has also introduced 135. see raj chetty et al., the opportunity atlas: mapping the childhood roots of social mobility, nat. bureau econ. rsch. 1 (2018). 136. id. 137. the agrihoods are coming, agritecture (june 17, 2021), https://www.agritecture. com/blog/2021/6/17/the-agrihoods-are-coming [https://perma.cc/t2mj-tm4q]; alli hurley, agrihoods: a new trend in lifestyle living, garden destinations, https://www.garden destinations.com/agrihoods-a-new-trend-in-lifestyle-living/ [https://perma.cc/haa2-8p3c] (last visited sept. 7, 2021) 138. see salzburg european declaration from the gasteinertal: interdisciplinary conference on ‘system change?!, ecowellness group 1 (2021). 139. id. 140. the agrihoods are coming, supra note 137; agrihoods, supra note 137. 141. see salzburg european declaration from the gasteinertal, supra note 138. 142. alex pearlman, living design elements create a serene, multisensory, healing 74 indiana health law review [vol. 19:47 sustainable fabrics recently, which were praised during the united nations conference of the parties (“cop-26”) to promote discuss sustainability.143 fungus clothing has been celebrated as a carbon-negative and organic alternative to fast fashion in the fashion world.144 in public and private spaces alike, cleanliness and hygiene have become monitored and improved as never before. aerosol sprays, air and water monitoring systems, and air purification systems are now studied, scrutinized, and improved upon. hygienic antibacterial surfaces optimized for cleanability and technologically enhanced kitchens became prominent as outdoor dining plummeted. home cooking boomed instead of getting ready to leave the house and spending considerable amounts of time commuting and facing the risk of infection outside.145 attention to healthy nutrition appears to be key for a whole-rounded long covid recovery as it helps bring down unwatned inflammation levels. especially those with gastrointestinal issues and post-viral arthritis appreciate an anti-inflammatory diets, which restrict any intake of too processed foods with additives such as glutamates, histamines, artificial falvors, and preservatives.146 while the motivation to leave cities for more rural areas may vary, it becomes apparent that for generation long haulers incentives to move back to cities have to outweigh the perceived health risks given adequate precautions. the longer and experience, neo life (dec. 24, 2020), https://neo.life/2020/12/biophilic-homes-prove-nature-isthe-best-medicine/ [https://perma.cc/a7kn-ehut]. 143. trends transforming the sustainable clothing industry outlook in 2021, linchpin seo, https://linchpinseo.com/trends-in-the-sustainable-clothing-industry/ [https://perma.cc/6drz-lvjw ] (last updated oct. 10, 2021); vanessa friedman, what was fashion doing at cop26?, wash. post (nov. 17, 2021), https://www.nytimes.com/2021/11/17/style/cop26-fashion-sustainability. html [https://perma.cc/7r3u-ygln]; amy nguyen, fashion industry’s material sourcing under spotlight at cop26 as un fashion industry charter for climate action scales its commitments, forbes (nov. 9, 2021), https://www.forbes.com/sites/amynguyen/2021/11/09/ fashions-materialsou rc in g-u n d er -spot l igh t -a t -cop2 6 -as -u n -fash ion -ch ar t e r -sca les -i t s -c lim a te commitments/?sh=73a367276b1a [https://perma.cc/dcv6-qyrj]; emily chan, how fashion is ramping up its climate efforts at cop26, vogue (nov. 9, 2021), https://www.vogue.com/article/ cop26-un-fashion-charter-climate-change-efforts [https://perma.cc/9dhn-cqfz]; nicky harley, cop26: how fashion industry aims to make sustainability fashionable, nat. news (nov. 8, 2021), https://www.thenationalnews.com/world/uk-news/2021/11/08/cop26-fashion-leaders-callon-firms-to-halve-emissions-by-2030/ [https://perma.cc/u35e-6ym6]; rachel cernansky, the fashion takeaways from cop26, vogue bus. (nov. 18, 2021), https://www.voguebusiness.com/ sustainability/the-fashion-takeaways-from-cop26 [https://perma.cc/e2aq-6y7b]. 144. jessica wolfrom, when fashion is fungal, wash. post (aug. 31, 2020), https://www. washingtonpost.com/climate-solutions/2020/08/31/fashion-musrhooms-mycelium-climate/ [https://perma.cc/u9r6-mvqm]. 145. alina dizik, top interior design trends of 2020: from home offices to two-tone kitchens, wall st. j. (aug. 16, 2020, 12:01 am), https://www.wsj.com/articles/top-interiordesign-trends-2020-11597342299 [https://perma.cc/9693-ked3]. 146. see salzburg european declaration from the gasteinertal, supra note 138. 2022] generation covid-19 long-haul 75 the deeper the life-changing effects of a covid infection appear, the higher the stakes will have to be to attract the skilled labor force to relocate back to cities and to induce workers to pick up their tasks back in their offices. in the eye of the rising concern over climate change and the interconnected environmental impact on covid long haulers’ well-being partially determined by external stressors, future cities may also see ecologic pricing reforms that take into account the trend toward healthy living and environmentalism.147 active cityscape projects may feature forestation to absorb co2 from the atmosphere but also governmental incentives for corporations to induce behavioral changes in their workforce.148 already now we see a trend towards possessing personal cars.149 further behavioral changes will likely force transportation to become more hygienic and individualized. the cities of tomorrow will also have to address intergenerational conscientiousness in protecting elder and low immune system risk groups from contagious diseases.150 corporate settings, industry demands and economic growth will likely stem from attuning to this trend of ecowellness and sustainable lifestyles in the future.151 the resiliency of corporations will increasingly require firms to ensure they work toward developing a healthy workforce.152 corporations are now incentivized to recruit, adopt, and cultivate ‘healthy human capital.’153 they will be more inclined to hire individuals that do not fall into certain risk groups, which could lead to discrimination due to medical pre-conditions.154 corporations will also need to develop practices that avoid contagion of the coronavirus with their work-force long-term to the extent that it still needs to interact physically.155 the respective job determines the degree of human contact, which varies by industry.156 precautionary measures include vaccination mandates, consulting outsourced staff briefings and trainings, long-term health management and prevention in teams, just to name a few advancements of the workplace towards a healthier and more consciously precautious environment.157 home office options and remote working will likely be expanded in light of 147. id. 148. julia m. puaschunder, the green new deal: historical foundations, economic fundamentals and implementation strategies, duke u. sch. l. (oct. 30, 2020), https://sites.law. duke.edu/thefinregblog/author/julia-m-puaschunder/ [https://perma.cc/lr3e-xht4]. 149. vaughn, supra note 123. 150. julia puaschunder, the future of the city after covid-19: digitionalization, preventism and environmentalism, consciens conf. proc., 125, 125 (2020). 151. see salzburg european declaration from the gasteinertal, supra note 138. 152. gelter & puaschunder, supra note 16. 153. id. 154. interdisciplinary, multimedia conference, supra note 12; puaschunder et al., supra note 98. 155. gelter & puaschunder, supra note 16. 156. id. 157. see julia m. puaschunder, from homo oeconomicus to homo praeventicus, proc. 19th rsch. ass’n for interdisc. stud. 153 (2020). 76 indiana health law review [vol. 19:47 covid long-haul risks.158 in new york, only 28% of the workforce have returned to their workspaces.159 a survey of 278 executives conducted by mckinsey found that office space is expected to decline by an average of 30% in the near future.160 this is partly due to employees enjoying working from home as the pew research center found in surveying 5,858 u.s. employees during fall of 2020. 49% of respondents reported having more flexibility while working from home, and 38% found it helped balance work and family responsibilities.161 in fact, 65% of u.s. teleworkers surveyed found online tools – such as video conferencing and instant messaging – as a good substitute for in-person contact.162 business travel is therefore expected to drop by 20%.163 inequality gaps open as low-wage workers are more likely at risk of needing to switch their jobs or be unemployed due to an automatization and artificial intelligence shock.164 in light of the covid long-haul threat and breakthrough cases, employees are expected to continue to work remotely — or at least follow a hybrid model in which only a reduced staff is at the premises concurrently. employees afraid of covid will give employers a hard time finding adequate human-facing labor.165 having experienced a great labor shortage, employers will likely face pressure to create a safe and secure working environment.166 rising tort liability risks for employers can be mitigated by hiring health consulting agents.167 158. chip cutter, remote work may now last for two years, worrying some bosses, wall st. j., (aug. 22, 2021, 5:30am), https://www.wsj.com/articles/remote-work-may-now-last-for-twoyears-worrying-some-bosses-11629624605 [https://perma.cc/g3by-sdvu]. 159. emily walsh, only 28% of new york city workers have returned to the office, according to a new survey, bus. insider (nov. 10, 2021, 2:44 pm), https://www.businessinsider. com/only-28-percent-new-york-city-workers-returned-to-office-2021-11 [https://perma.cc/ra6yyyjl]. 160. the future of work after covid-19, mckinsey & co. (feb. 18, 2021), https://www. mckinsey.com/featured-insigh ts/fu ture-of-work/the-future-of-work-after-covid-19 [https://perma.cc/2acw-uaj8]; brienne walsh, how work life is changing: again, synchrony (july 14, 2021), https://www.synchronybank.com/blog/millie/how-work-life-is-changing/ [https:// perma.cc/9apd-a24t]. 161. kim parker et al., how the coronavirus outbreak has – and hasn’t – changed the way americans work, pew rsch. ctr. (dec. 9, 2020), https://www.pewresearch.org/social-trends/2020/ 12/09/how-the-coronavirus-outbreak-has-and-hasnt-changed-the-way-americans-work/ [https://perma.cc/d5wt-vm9k]; walsh, supra note 160. 162. id. 163. id. 164. id., the future of work after covid-19, supra note 160; walsh, supra note 160. 165. stella yifan xie & liyan qi, chinese factories are having labor pains: ‘we can hardly find any workers’, wall st. j., (aug. 25, 2021, 5:30 am), https://www.wsj.com/articles/ ch inese-factories-are-having-labor-painswe-can-hardly-find-any-workers-1162988 3801?st=n4ymwhvkdlscgp5&reflink=article_email_share https://perma.cc/46ls-496s]. 166. the great american labor shortage, wall st. j. (june 8, 2021), https://www.wsj.com/ articles/the-great-american-labor-shortage-11623191784 [https://perma.cc/4g6v-l64m]. 167. id. 2022] generation covid-19 long-haul 77 already now in germany being infected with covid-19 can be considered a workplace-related accident if the infection happened at the workplace premises and/or a human-contact with co-workers, clients or customers led to it.168 after filing for a workplace accident claim, there is likely an investigation to follow if the employer was offering working conditions in line with governmental regulation with a particular focus on prevention.169 in certain professions, a covid infection is considered an occupational disease due to high exposure to other people. for instance, healthcare and medical examination practitioners, opticians, social services, but also wellness and pedicure professionals can count that they have high risks of exposure to the virus in their work.170 unclear remains the status of professions such as bus and train drivers, logistics and delivery services but also aviation, flight attendants and school and kindergarten teachers.171 recognition of covid infections as workplace-related accidents is an important prerequisite for cost coverage of documentation, treatment and rehabilitation beyond the medical sphere including social factors.172 for instance, in the case of a long covid trajectory, a workplace-related infection can aid in acquiring social service benefits and a potential transition to a different profession or workplace if there is a long-term disability or disabling condition that hinders continuous working.173 besides health and social insurance, also the family is covered in case the infection at the workplace has led to death.174 in order to avoid a covid infection in the corporate sector to begin with, the german präventionsgesetz or prevention act175 allocates governmental funding to corporations for prevention measures and building team sports.176 the covid pandemic has elevated employers to create a healthy and hygienic work environment with thoughtful interaction, constantly tracking workforce safety and requiring health selfand group monitoring. benefits that harness mental health and physical wellbeing take center stage and even outperform financial wellness planning after covid.177 already now, many workers look forward to retiring 168. klaus deuse, corona virus as an accident at work, deutsche welle (may 21, 2021), https://www.msn .com/de-de/finanzen/top-stories/corona-virus-als-arbeitsunfall/araakh9ev?ocid=msedgdhp [https://perma.cc/lq7m-yqy9]. 169. id. 170. id. 171. id. 172. id. 173. id. 174. id. 175. prevention act, bundesministerium fur gesundheit, https://www.bundesgesund heitsministerium.de/service/begriffe-von-a-z/p/praeventionsgesetz.html [https://perma.cc/2xkx8lr4] (last updated aug. 6, 2019). 176. interdisciplinary, multimedia conference, supra note 12. 177. benefits take center stage: the pandemic spotlights the importance of employee benefits now more than ever, union bank switz., https://www.ubs.com/us/en/wealthmanagement/ our-services/ubs-workplace-wealth-solutions/workplace-wealth-solutions-thought78 indiana health law review [vol. 19:47 early, and the covid long haul generation will likely exacerbate this trend.178 those who work enjoy home office flexibility that outsources workplace health risks, while office glass walls in interior designs are being placed for security protection in workplace premises.179 the downside of remote work, however, lies in problems of accountability and stagnation in promotions as there is less oversight of performance in a home office.180 industries that have already established online quality control in place, will likely have a competitive advantage. the coronavirus crisis has highlighted the importance of prevention as a necessary prerequisite for health in general medicine. self-conscious prevention and the general status of the immune system have proven to be decisive prerequisites for whether a covid-19 infection turns out to have a severe or only a mild disease trajectory.181 even when an initial coronavirus infection is mild, among about 10-50% of those previously infected the body becomes symptomatic in the long term, with the immune system becoming unbalanced and/or overshooting.182 the diffuse symptoms of long covid are not yet fully understood, as there may be a complex interplay with genetic predispositions and environmental circumstances. while the waves of symptoms faced and recovery of covid-19 long haulers are still not clear, recent evidence suggests that external and synthetic influences can trigger an overshooting immune reaction that causes harm to one’s own body.183 scholars have therefore suggested that long-haul patients and chronic disease sufferers will become aware of and hypersensitive to their surroundings, resulting in a preference for balance and harmony with the natural environment rising.184 generation covid-19 long-haul will likely shift towards a healthy lifestyle with awareness for environmental balance. attention to protect the environment but also caution to avoid drug residues in the groundwater will spring out from the wish to create a non-stressful surrounding without environmental stressors and/or inflammation triggers. with international trade still being in a downturn and international value chains becoming riskier and more expensive, consumers attuned to their surroundings have developed an interest in shopping locally.185 first attempts to leadership/workplace-voice.html [https://perma.cc/rf4a-kg2l] (last visited sept. 10, 2021). 178. id. 179. walsh, supra note 160. 180. emma harrington & natalia emanuel, 'working' remotely? selection, treatment, and market provision of remote work, harvard, https://scholar.harvard.edu/eharrington/publications/ working-remotely-selection-treatment-and-market-provision-remote-work [https://perma.cc/x9rkmf72] (last updated apr. 9, 2021). 181. salzburg european declaration from the gasteinertal, supra note 138; gelter & puaschunder, supra note 16. 182. hart, supra note 9. 183. drbeen medical lectures, supra note 10. 184. salzburg european declaration from the gasteinertal, supra note 138; gelter & puaschunder, supra note 16. 185. lighthizer, supra note 122; shalal et al., supra note 122; gertz, supra note 122; the 2022] generation covid-19 long-haul 79 eliminate points of contraction in stores include online delivery services, which may in the future be enhanced by drones. with people enjoying time off work in their ecowellness hubs, low-paying service industry jobs with high human touchpoints such as nursing, flight attendants, restaurant waiters, etc. will face massive staffing shortages. labor supply shortages have and will continuously increase labor bargaining power and drive-up worker salaries but may also increase corporate social responsibility pressures to create a positive work-life balance in harmony with nature. 4. socio-psychological evolution impacting labor dynamics speculation about prehistoric situations where humans survived in caves serves as a useful analogy for lockdowns. researchers at the university of vienna study the group dynamic and socio-psychological impact of crises as a driver of human advancement.186 as these researchers outline, seclusion in caves held enormous potential for human and societal development, which may also apply regarding covid.187 during periods when natural disasters made exterior living conditions dangerous, paleolithic humans developed so-called “cave competencies.” these key competencies grew when people had to seclude themselves from society – e.g., during natural disasters, volcanic eruptions, but also during seclusion of later-following pandemics, such as the great plague of the 14th century. historically, crises often became hallmarks of societal advancement after all.188 times of societal pressure often advanced to shock therapies pushing humankind toward social advancement, for some parts due to a stark natural selection effect.189 “cavers” were more likely to estimate risks and imagine future consequences, and they were able to maintain a natural circadian rhythm without being guided by changes in natural light.190 psychologically stronger, more self-reflective and cooperative individuals with better sensitivity to the passage of time, a better ability to discount risk over time, and with better social competencies had a natural advantage when caving together.191 according to this theory, humans in seclusion learned to live by themselves and handle their emotions during stress, but also developed better imagination.192 drawing inferences from the potential rise of “cave competences” during the steam has gone out of globalisation, supra note 122; multinational companies are adjusting to shorter supply chains, supra note 122. 186. see jürgen grimm, conspiracy theories in times of crises: methods and results of an online survey, u. vienna (nov. 2020), https://empcom.univie.ac.at/fileadmin/user_upload/p_ empcom/pdfs/grimm2020_conspiracytheory_researchtalk_6.pdf [https://perma.cc/fj3xggmv]. 187. id. 188. id. 189. id. 190. id. 191. id. 192. id. 80 indiana health law review [vol. 19:47 currently ongoing pandemic, pro-active care for maintaining a healthy workforce will become an essential corporate feature to attract qualified labor, whose bargaining power has already increased because of labor shortages in humanfacing industries and positions.193 the long-haul prospect and prolonged covid pandemic has raised u.s. job openings to historic highs and the share of u.s. corporations not being able to fill positions has increased to 15%, which accounts for a record highest rate ever measured.194 at the same time, more workers are quitting with the job quit rate at an all-time high at 2.7% in june 2021.195 long covid will likely drive this power dynamic shift even further and extend it to other industries, once natural supply-demand dynamics in the labor market kick in. the overall long-term well-being of employees including preventive care in teams will become a key issue and competitive advantage to attract a productive workforce for employers of tomorrow. learning-in-teams to prevent virus contagion will become a new endogenous growth factor when considering the risk of long-term debilitation of trained key personnel after a covid-19 infection.196 future employers will likely naturally but also will have to develop empathy and a holistic understanding of health. in work teams responsible self-care of prevention in harmony with society and the environment will prevail. a shared culture of group prevention efforts will play a key role. salutogenesis funded and supported by the employer nurturing a healthy and ecologically harmonious lifestyle will be a future competitive advantage in the labor market that helps attract scarce labor. working from home will have changed employees to become more independent and sensitive to personal time, but they will also be more focused on the health and well-being of their immediate surroundings.197 in light of growing concerns over covid long-haul risks but also addressing the newest findings about the interaction of environmental influences on longhaul conditions, employers will likely have a pioneering first mover advantage if they pay attention to the holistic expertise for prevention standards. for instance, quick and accurate covid tests, screening of employee healthcare status but also providing a safe and secure work environment will be crucial. this means that the environment will be constantly monitored for harmful influences. 193. whelan, supra note 14. 194. ghilarducci, supra note 14; whelan, supra note 14. 195. id. 196. puaschunder et al., supra note 98. 197. recognizing the duty of the federal government to create a green new deal, h.r. 109, 116th cong. (2019); edward barbier, a global green new deal, united nations, https:// ustainabledevelopment.un.org/index.php?page=view&type=400&nr=670&menu=1515) [https://perma.cc/af4t-y4qf ] (last visited jan. 11, 2021); see also mariana pargendler, the rise of international corporate law, eur. corp. governance inst. 1 (2020) (providing a historical overview of un initiatives relating to esg, particularly climate change); letter from members, earthworks, to representatives, 116th congress (jan. 10, 2019), https://earthworks.org/ publications/group-letter-to-congress-urging-green-new-deal-passage/ [https://perma.cc/a2l3fxma]; puaschunder, supra note 148. 2022] generation covid-19 long-haul 81 standards for safety and security provided by protective masks but also a healthy stable in-house nutrition based on an informed understanding of the individual’s personal dietary needs will become implicit benefits to attract labor and make a difference when scarce labor decides between potential employers.198 certain ecowellness standards even go as far as to regulate the ecological, health and social criteria for nutrition, including vegan products.199 fringe benefits provided by employers may be extended to include holistic preventive care and foresighted vigilance but also insurance coverage for long-term disability after a workplaceinduced covid infection. legal implications, insurance coverage in the entire social compound but also privacy considerations when dealing with sensitive personal health status information in the workforce over time are rising legal, economic, discriminatory, and ethical challenges that may imply risks such as discrimination, litigation and erosion of the social glue. multi-faceted predicaments will likely arise in the shadow of all these novel developments for generation covid long-haul. salutogenic prevention is currently imbued in the work cultures. governmental support in large-scale regulation and subsidies could support prevention and holistic healthcare.200 the non-specific immune system response to covid in long haulers will require workplaces to be in harmony with the environment. long haulers will strive to eliminate stress, which will also require society to limit weather-related problems in light of climate change. current levels of global warming are causing weather extremes, which can exacerbate unnecessary stress levels. all such wide-scale transformation can be guided by the green new deal and the european sustainable taxonomy targeted at stabilizing a favorable climate and livable environment based on classifying industries and policies’ effects on human health and well-being.201 public crowd events will likely also require more precaution and an implicit understanding of care for others’ well-being. civil networks, independent scientists and favorable framework conditions in line with the “green deal” pledge can change entire communities and revive the self-determined idea of health in harmony with the environment during our turbulent time.202 198. salzburg european declaration from the gasteinertal, supra note 138. 199. grimm, supra note 186. 200. id. 201. barbier, supra note 197; see also pargendler, supra note 197 (providing a historical overview of un initiatives relating to esg, particularly climate change); letter from members, earthworks, supra note 197; h.r. 109; a european green deal, eur. comm’n, https://ec. uropa.eu/info/strategy/priorities-2019-2024/european-green-deal_en [https://perma.cc/m36e-h7a9 ] (last visited jan. 11, 2021); puaschunder, supra note 148; the biden plan for a clean energy revolution and environmental justice, biden harris, https://joebiden.com/climate-plan/ [https:// erma.cc/fvu8-ktzt ] (last visited jan. 11, 2021). 202. alexandra samuel, how working from home has changed employees, wall st. j., (june 12, 2021, 8:00 am), https://www.wsj.com/articles/working-from-home-employees-116234 3249 [https://perma.cc/gn7m-skle]. 82 indiana health law review [vol. 19:47 b. digitalization and democratization of healthcare information 1. isolation of generation lockdown and the digitalization boom as discussed in section 3.1.4, in the history of humankind, the ability to use imagination and to innovate often prospered when humans were isolated during times of crises. not to idealize covid lockdowns or envisioning flying to mars these days, the novel coronavirus pandemic has shock-forced generation covid lockdown to socially-distance as never before during modernity.203 as the fear of a virus contagion through human contact led to lockdowns in all major economies around the globe, the power of digitalization became the source of touchpoint-less contact with the social compound during the pandemic. in modern covid ‘caves,’ imagination is currently stimulated in virtual online worlds that reached unprecedented sophistication during the crisis.204 while many covid long haulers locked their doors to keep out aerosols and the actual physical surroundings’ importance faded, laptop windows to the world became the most important ever-open gate to escape, communicate and socialize at any given time of day or night.205 the economic recovery after covid-19 is expected to be digital.206 the longer and riskier a covid infection risk is perceived to prevail, the more will society adjust to digitalized interaction and truly global information exchange.207 covid-19 accelerated an already ongoing digitalization disruption.208 algorithms, robotics, and big data insights have experienced more widespread use and general acceptance within society during the covid-19 crisis.209 digitalization accounts for a booming industry in the wake of the covid-19 pandemic. the workforce is now more than ever before divided on skills relating 203. see preventing a 'lockdown generation' in europe and central asia, united nations child. fund 1 (2020). 204. grimm, supra note 186. 205. tanya basu, covid-19 “long haulers” are organizing online to study themselves, mit tech. rev. (aug. 12, 2020), https://www.technologyreview.com/2020/08/12/1006602/covid-19long-haulers-are-organizing-online-to-study-themselves/ [https://perma.cc/rlc2-dqvr]. 206. id., see also the next normal: the recovery will be digital, mckinsey & co. 1 (2020). 207. alfea jamal, coronavirus pandemic: fear and dread haunt covid-19 ‘long-haulers’ months after infection, hindustan times (sept. 3, 2020), https://www.hindustantimes.com/ health/coronavirus-pandemic-fear-and-dread-haunt-covid-19-long-haulers-months-afterinfection/story-eyw9zl5u3jfrvgs1qaezqn.html [https://perma.cc/wjs8-j6cp]. 208. see generally julia m. puaschunder & martin gelter, the social representations and legal theory of artificial intelligence, robotics and big data in healthcare (june 11, 2020) (unpublished manuscript) (discussing a survey on the intersection of these sectors). 209. see julia m. puaschunder, artificial intelligence market disruption, rsch. ass’n for interdisc. stud. 1 (2019); digi-disruption & new age renaissance, tuthetop alumni club, https://tuthetop-alumni.at/digidisruption/ [https://perma.cc/st3b-lf4n] (last visited dec. 30, 2021). 2022] generation covid-19 long-haul 83 to technology use and human-machine compatibility.210 those with better access to internet connectivity and greater affinity toward technology (i.e., computer and artificial intelligence literacy) have growing competitive advantages. the already pre-pandemic existing gap between e-skilled and e-unskilled workers based on novel technology adoption has widened since the outbreak of covid.211 the worldwide lockdowns, social distancing, and remote work solutions in all major economies increased a worldwide rapid adoption of instant communication tools, social engagement, and entertainment platforms.212 the covid-induced deurbanization described in section 3.1.2. was therefore not comparable to a ruralization. people in the suburbs or in smaller towns did not give up luxuries of metropolitan areas, such as the exchange of goods, services, and ideas in highly specialized markets with diverse market actors. today’s cosmopolitan luxury shifted into virtual online spaces as covid-19 unprecedentedly expanded the reach of the online tech world. physically distant, we became digitally closer. data traffic increased around the world but also in speed.213 an online multitasking workforce gained global reach, while technology reduced bureaucracy.214 digitalization affected all industries and is expected to revolutionize medical care of the future.215 historically, ancient epidemics were turning points that eventually fostered innovation in mechanization given human labor shortages and reductions in productive capacity.216 persistent and recurring covid-19 lockdowns in combination with the potential for reinfection among already traumatized long haulers will likely turn society more and more toward digitalization for purposes of social interaction, information exchange, productivity, and entertainment.217 210. see charles i. jones & paul m. romer, the new kaldor facts: ideas, institutions, population, and human capital, nat’l bureau econ. rsch. 1 (2009). 211. glaeser & cutler, supra note 119; kathryn e. bouskill & scott w. harold, inequality in opportunity to work from home an underlying condition likely aggravated by the pandemic, rand corp. (may 14, 2021), https://www.rand.org/blog/2021/05/inequality-in-opportunity-towork-from-home-an-underlying.html [https://perma.cc/n35f-v24h]; julia m. puaschunder, nudgital: critique of a behavioral political economy, 5 archives bus. rsch. 54, 57-59 (2017). 212. see titus corlatean, risk, discrimination and opportunities for education during the times of covid-19 pandemic, rsch. ass’n for interdisc. stud. 37 (2020). 213. joseph johnson, coronavirus: impact on online usage in the u.s.: statistics & facts, statista (apr. 29, 2021), https://www.statista.com/topics/6241/coronavirus-impact-on-onlineusage-in-the-us/ [https://perma.cc/stp8-m6px]. 214. nina owcharenko schaefer, removing obstacles, cutting red tape, and staying flexible in responding to covid-19, heritage found. (mar. 25, 2020), https://www.heritage.org/publichealth/commentary/removing-obstacles-cutting-red-tape-and-staying-flexible-responding-covid [https://perma.cc/adr8-fjba]. 215. glaeser & cutler, supra note 119. 216. piper, supra note 117. 217. phebe tucker & christopher s. czapla, post-covid stress disorder: another emerging consequence of the global pandemic, psychiatric times (jan. 8, 2021), https://www. psychiatrictimes.com/view/post-covid-stress-disorder-emerging-consequence-global-pandemic 84 indiana health law review [vol. 19:47 remote work solutions influence labor relations and change the bargaining power of capital relative to labor.218 the specific new balance will depend largely on the degree of digitalization of the employee’s job, and on the e-versed specialization of their human capital.219 human capital will become less firmspecific where remote work becomes the norm, given that employers can recruit employees on an international scale with the internet making the whole world labor force available at a mouse click.220 2. artificial intelligence-enhanced medical care and online healthcare information exchange during the pandemic, robotics began to facilitate patient care and hygiene tasks around covid infected. robots have also taken on everyday supply chain tasks, such as self-driving trucks, shelving groceries, administering checkouts or delivering items with drones.221 in the household, robots are becoming useful as cleaning, cooking and household devices. during the pandemic, more and more decision making became outsourced to algorithms. in the future lawyers, doctors, finance professionals and secretary tasks are expected to become more and more replaced by computers and artificial intelligence.222 digitalization could also come in handy in the search for practical disability support for long haulers. artificial intelligence, robotics and big data may offer essential complements to fill in for long-haul attention and productivity deficits gaps that may occur in waves. robotics and automated computer systems promise to help covid long haulers navigate through complex situations of information overload.223 artificial intelligence could offer the opportunity to aid long haulers in dealing with a complex world when waves of fatigue set in unexpectedly and unpredictably. for instance, already now computer programs and algorithms can learn how individuals respond and serve as secretaries to book appointments or [https://perma.cc/q29u-qvxk]. 218. gelter & puaschunder, supra note 16. 219. id. 220. id. 221. scott tong, pandemic innovation: supermarkets invest in robot pickers as online ordering takes off, marketplace (mar. 12, 2021), https://www.marketplace.org/2021/03/12/ pandemic-innovation-supermarkets-invest-in-robot-pickers-as-online-ordering-takes-off/ [https://perma.cc/4lnm-a4uv]; see also zeashan hameed khan et al., robotics utilization for healthcare digitalization in global covid-19 management, 17 int. j. env’t rsch. & pub. health 3819 (2020); sergio d. sierra marín et al., expectations and perceptions of healthcare professionals for robot deployment in hospital environments during the covid-19 pandemic, 8 frontiers robotics & ai 1 (2021); théo schöpfer & reza etemad-sajadi, the clever use of robots during covid-19, ehl insights, https://hospitalityinsights.ehl.edu/robots-during-covid19 [https://perma.cc/7fbn-3e3t] (last visited aug. 26, 2021). 222. see julia m. puaschunder, the legal and international situation of ai, robotics and big data with attention to healthcare, eur. parliament agency 1 (2019). 223. id. 2022] generation covid-19 long-haul 85 structure workflows.224 future advances in digitalization in the medical sector also lie in bundling information for the prevention of pandemics and tracking medical resources.225 the digital age features real-time information recording in combination with unprecedented data storage opportunities and computation power, such as bayesian analytics, and has created the most innovative advancements to improve human lives with digitalization.226 in the medical sector, individual medical information could be interpreted in the context of larger datasets in order to diagnose and predict the individual health status and likely outcomes of covid infections and other medical conditions. to prevent future pandemics, mobile monitoring and digital health resource tracking will play an unprecedented role. thanks to new technologies for self-motivated health monitoring, it is currently possible for everyone to track their health independently and change their lifestyle over a longer time horizon self-determined. individualized health status apps are currently being developed to track body functions and detect virus infections in real-time. big data that is used to obtain objective disease risk and outcome trajectories every person faces can aid in optimizing one’s lifestyle and health to prevent negative lifestyle choice consequences early on.227 currently emerging innovations in this realm include real-time monitoring of the immune system and microchips for tracking biomarkers. big data and the use of bluetooth technology for a cartography of healthcare devices are prospectively used to overcome bottlenecks allocation problems and combat the misuse of resources.228 digitization enables access to medical information worldwide without the risk of corruption by creating telehealth services and allowing users to gather preliminary information in internet forums. insights derived from massive amounts of data can be used for widescale prevention, diagnosis and healing. new technologies can now relate personal symptom prevalence to psycho-social tendencies and general environmental influences and risk factors in order to redefine salutogenesis truly holistically.229 in light of the enormous potential to digitally monitor and track healthcare statuses worldwide and over time, big data offers an enormous potential to detect the outbreak of pandemics early on but also the possibility to capture widespread health trends and group reactions. covid-19 long haulers may trigger large-scale societal trends by initiating a widespread artificial intelligence revolution that will comprise it solutions for medical self-monitoring, constant health status tracking and real-time scanning of the environment for harmful influences. new possibilities for data storage and 224. ivan stevanovic, free appointment scheduling software: our top picks, small biz genius, (dec. 30, 2021), https://www.smallbizgenius.net/free-appointment-scheduling-software/ #gref [https://perma.cc/xj93-hf6w]. 225. interdisciplinary, multimedia conference, supra note 12. 226. id. 227. id. 228. id. 229. id. 86 indiana health law review [vol. 19:47 evaluation open up previously unforeseen ways to allow users of social networks to develop holistic healthy lifestyles and take measures to prevent illness.230 as never before in the history of humankind, individuals are now monitoring their health status in real time and find themselves online to evaluate medical goods and services together. already now during the ongoing pandemic, covid long haulers began to seek fast, easy and truly global access to information about potential remedies for their condition, which are typically not provided by standard medical care.231 long haulers have already found themselves in online self-help groups – such as the facebook survivor corps – or decentralized information exchange – such as the patient research covid-19 platform, a patient-led research collaborative232 – for quick and unbureaucratic information exchange about an emerging group phenomenon. social online media platforms were instrumental in detecting that covid may cause a long-lasting health effect that may kick in with an even longer time lag than the standard incubation time and may show surprising body and psychological changes. social online media captured this trend early on. in digitalized platforms, long haulers gathered information self-determinedly in online surveys during a time when covid emergency hospitalization was precluded by a surge of severe covid cases. in the future, instant information exchange on social media may also lead to a democratization of healthcare information without medical professionals as gatekeepers. fear of attending hospitals or seeking medical aid at potential viral transmission points has already created a wave of telemedicine and online healthcare information exchange. especially in the long hauler segment, where novel, diffuse and often unclarified symptoms appear in waves, laypeople are already turning to fast and easy information exchange in online social media selfhelp groups, such as the facebook long hauler survivor corps groups. these groups serve as open forums to discuss potentially unfamiliar symptoms. as the list of covid long-haul long-term debilitation continues to expand, long haulers are in the search for fast relief online. social media networks provide widespread options for gathering and strategically collecting crowd opinions on long covid remedies but also provide socio-psychological support from fellow sufferers. guided lifestyle monitoring in a social self-help group can strengthen self-confidence and social cohesion in online forums. these long haulers meet online to discuss their pressing symptoms and to crowdsource information on currently evolving trends in medical care in order to then inform scientists based on their amalgamated narrative data.233 in this service, covid long haulers see themselves as citizen scientists who organize 230. id. 231. basu, supra note 205. 232. about the patient-led research collaborative, patient-led rsch. collaborative, https://patientresearchcovid19.com/ [https://perma.cc/trs2-q5tq] (last visited dec. 30, 2021). 233. amy dockser marcus, covid-19 patients are doing their own research, wall st. j. (jan. 30, 2021, 12:01 am), https://www.wsj.com/articles/covid-19-patients-are-doing-their-ownresearch-11611982860 [https://perma.cc/r7ly-jp6l]. 2022] generation covid-19 long-haul 87 information – for example through online surveys – and make their findings available to scientists, industry and government representatives in order to improve the current health system.234 results obtained in simple, unbureaucratic surveys are currently presented to the medical profession and policy makers but also a wide range of media outlets in the quest of finding widespread recognition for covid long-haul symptoms and fast working remedies.235 these covid long haul forums often expand the range of healing methods to more holistic and alternative remedies. this tendency toward bottom-up information gathering is a form of crowdsourcing of information on covid-19 and its unforeseen long-term consequences. these introspective observer positions of self-determined patients sometimes appear in a more informed position than the medical sector. their remaining online not only lifts pressure from currently overwhelmed medical personnel in hospitals. in their fast and unbureaucratic exchange and in their role as informants to government officials responsible for health and well-being, long haulers have become a self-determined and highly engaged crowd information source for fast problem-solving that can relieve the general health system. this trend captures a newly developing online democratization of healthcare information. 3. alternative medicine and ecowellness trends for prevention the rise in medical self-help online and mutual support will have profound implications for the regulation of the medical profession. covid long haulers tend to stretch cure options for alternative medicine solutions that rebalance their stressed immune systems. in online forums and digitalized exchange, long haulers guide a holistic, democratic expansion of the repertoire for healing and prevention.236 the widening of discussion forums about the social representations of covid-19 symptoms could instigate a transformation of the health system. alternative remedies that can restore balance and a natural immune system reset but also harmony with the environment have already been identified as possible cures for long covid. acupuncture, intermittent and therapeutic fasting, herbal alternatives and dietary supplements – such as yogurts for preand pro-biotics – but also yoga and meditation are already booming trends in covid long-haul online internet forums.237 these easily understood alternative means 234. interdisciplinary, multimedia conference, supra note 12. 235. id. 236. id. 237. lauren berlant, cruel optimism (2011); see also jürgen vormann, magnesium: nutrition and homoeostatis. 24 molecular aspects med. 27 (2003); lucy chen & andreas michalsen, management of chronic pain using complementary and integrative medicine, 357 brit. med. j. 1284 (2017); puaschunder, supra note 222; kuno hottenrott et al., exercise training, intermittent fasting and alkaline supplementation as an effective strategy for body weight loss: a 12-week placebo-controlled double-blind intervention with overweight subjects, 10 life 74 (2020). 88 indiana health law review [vol. 19:47 that also include foresighted prevention, nutrition supplements and a healthy antiinflammatory diet are rooted in different incentive mechanisms compared to those set by the pharmaceutical market. for instance, fasting as abstaining from food is often sidelined in the range of options presented to patients. while the reasons for this remain opaque, one can only speculate about the economic incentives of the food and pharmaceutical industry. reducing one’s calorie intake has a different economic impact than a break-through medication that can have extraordinarily high sales margin, as pharmaceuticals are typically on top of the price mark-up range per industry. a healthy diet, yet, also has a lower carbon footprint than the marketing of new drugs, which often require chemicals and trials that may end up as non-excludable debris in the drinking water. dieting may also have less unexpected externalities and risks if done with caution than new drug trials. the lobbying of the pharmaceutical industry and the incentives sometimes set by professional groups may influence the opinion of medical professionals. discussing fast remedies online with similarly affected patients, portrays the information sharing among fellow covid long haulers more innocently and certainly filled with more empathy for fellow sufferers. in the end, covid long haulers are undergoing a shared struggle that is not well understood and sometimes not recognized by professionals as such yet. because long-term covid sufferers are often rather young, long-term medication would not only cause the known side effects, such as collateral organ damage, but also possible psycho-social consequences such as stigmatization and psychological trauma of despair and misunderstanding by the medical profession. alternative medicine and information exchange online appears as an at least considerable option. the projected growing number of chronically long-term disabled covid long haulers and those with autoimmune system imbalances increases the importance and value of preventive medicine with a long-term impact. alternative remedies offer the potential to reset the immune system and create harmony with the environment. preventive and alternative medicine are inclusive alternatives that also integrate the big picture of external environmental conditions. chronic diseases and their therapy can be treated most successfully if the diverse and changing spectrum of health and disease is understood from the point of view of systems biology and with regard to the natural and social environment as a source of calming factors or stressors. big data gathering and crowdsourcing of information enables to integration of a wide-range data in exploratory analysis to understand systems change avenues. holistic processoriented systems also integrate traditional healing methods as well as the humanities, psychosomatics, spirituality, and art.238 the longer the covid pandemic endures, and the deeper the long-haul crisis runs through society, the more alternative solutions shared online are expected to gain ground in the overall spectrum of remedies available to long haulers. the rise in medical self-help and mutual support will have profound implications for the regulation of the medical profession and will likely boost alternative medicine 238. interdisciplinary, multimedia conference, supra note 12. 2022] generation covid-19 long-haul 89 and over-the-counter remedies. implicit monopolization of pharmaceutical markets and biased subscription regimes may become harder when access to healthcare information and medication remedy but also drug performance and side effects become more transparent in crowdsourcing of information on drugs in the digital age. in the future, covid long haulers may shift focus from seeking treatment in emergency situations toward prevention. as long haulers face recurrent flareup episodes of symptoms, they will naturally develop an appreciation for foresighted medical care, hence prevention. we already now experience a trend of covid long haulers being extraordinarily cautious and anxious about getting sick again. promoting prevention and general healthcare in the future in a more decentralized way will likely shift the political economy power dynamics between patients and doctors but also the healthcare framework surrounding medical care. self-determined information exchange about prevention may ennoble humans with feelings of internal self-control. long-haul patients as experts of their own emerging disease, demand to become patients as partners within the medical care.239 a more egalitarian access to preventive health rather than finding oneself debilitated and confronted in an emergency care hierarchy dependent on life-saving support of doctors can build a more informed, rational, and strategic decision-making path.240 preventive protection and general salutogenesis will become features of success for individual lives, families, corporations and whole societies of the future, who may have a more egalitarian access to health and well-being as a common good through online access to medical information.241 4. ethical predicaments in the democratization of healthcare information online in the current formation of ethical standards for artificial intelligence and big data, these novel technologies and the insights derived from them offer enormous benefits for society. at the same time, ethical predicaments arise out of the use of these novel technologies that potentially infringe on laws and human beings and impose risks to societal welfare.242 a stakeholder survey conducted in november 2019 revealed that perceived risks in the use of big data in healthcare include data misuse and leakage leading to privacy infringements, as well as biases and errors. big data insights open gates for differential health care pricing, stigmatization, social stratification, 239. harvard t.h. chan school of public health, understanding long covid: the unseen public health crisis, youtube (nov. 19, 2021), https://www.youtube.com/watch?v=5sjixbvkow [https://perma.cc/e2xt-k8tn]. 240. julia puaschunder, behavioral economics and finance leadership: nudging and winking to make better choices (2020). 241. interdisciplinary, multimedia conference, supra note 12. 242. see jamie harris & jacy reese anthis, the moral consideration of artificial entities: a literature review, 53 sci. & eng’g ethics 1 (2021). 90 indiana health law review [vol. 19:47 discrimination, and market manipulation.243 while big data mining companies are still developing their role in the healthcare industry and seek to extend their market reach, the biggest leaders in the field are still facing an uphill battle, with – for instance – google recently closing its own health division.244 the downsides of crowdsourcing information about health online are novel emerging potential liability risks and unknown legal as well as ethical boundaries. international big data exchange could set standards for future pandemic prevention but should also provide big data privacy protection and legal antidiscrimination means against misuse of sensitive information that leads to stigmatization of vulnerable patients’ exposure of their conditions. instant online exchange of sensitive information about one’s health status makes citizen scientists particularly vulnerable in terms of their privacy and potentially susceptible to online marketing campaigns under medically impaired conditions. but also the long-term impact of publicly disclosed sensitive information that is shared bit-by-bit online over time appears sensitive and not foreseen in humans, especially likely in the impaired.245 in the digital age, it is difficult to estimate what effects the piecemeal sharing of private information will have over time, when, for example, personal health information disseminated in an internet forum is absorbed into large datasets. if information is analyzed and displayed in relation to other individuals’ performance, a combined dataset could open gates for discrimination and stigmatization. the anonymous participation in new virtual realities currently also brings along completely new problems such as cyber-crime, hate postings and social censorship by online mobs, which could be particularly harmful to vulnerable patients seeking remedies online. governments and traditional media have lost control over the public opinion formation in the digital age. legal protection includes privacy in “big data” and the individual “right to be forgotten” online as well as the dignity of conscientious data protection and online privacy protection.246 healthy and informed access to new media needs to address the 243. puaschunder & gelter, supra note 208. 244. ruth reader, with a wearable reportedly in the works, facebook continues a quiet push into health, fast co. (feb. 19, 2021), https://www.fastcompany.com/90606044/facebookhealth-tracker-wearable [https://perma.cc/nxa4-jpmg]; paddy padmanabhan, is healthcare too hard for big tech firms?, healthcare it news (aug. 23, 2021, 3:23 pm), https://www. healthcareitnews.com/blog/healthcare-too-hard-big-tech-firms [https://perma.cc/95r8-2tn2]; donna cusano, breaking: google health shutting down, most employees scattered to other divisions (updated), telehealth & telecare aware (aug. 21, 2021), https://telecareaware. com/breaking-google-health-shutting-down-most-employees-scattered-to-other-divisions/ [https://perma.cc/sd4s-ff8r]. 245. see julia m. puaschunder, data fiduciary in order to alleviate principal-agent problems in the artificial big data age, 46th e. econ. ass’n conf. 1 (2019). 246. julia m. puaschunder, the nudging divide in the digital big data era, 4 int’l j. res. bus., econ. & mgmt. 49, 49 (2017); see also effy vayena et al., machine learning in medicine: addressing ethical challenges, 15 pub. libr. sci. med. 1 (2018) (discussing privacy issues regarding the use of machine learning on medical data). 2022] generation covid-19 long-haul 91 dilemma between the individual benefit from information exchange online versus the human dignity of privacy on the internet.247 on a wider societal scale, the digitalization disruption also brings along novel inequalities.248 inequality in internet connectivity, tech skills and affinity to digitalization leverages artificial intelligence-human-compatibility as a competitive advantage. digital online working conditions that make individual living conditions transparent emphasize social hierarchies in our work-related interactions and may further transpire differences in social status in business and educational settings. new approaches to teaching and learning have highlighted novel inequalities – such as disparities in the private spaces and access to digitalization benefits as well as internet infrastructures and favorable time zones. as access to healthcare and education have become pegged to virtual experiences, we need to rethink the democratization of internet access and online availability. inequality divides opening based on the online access and technology affinity determining the availability of health care, education and emotional well-being should become subject to policy intervention in order to avert societal downfalls that leave behind welfare potential in education and learning. taxing internet generated gains could provide the fiscal space to offset online inequalities in granting access, tools and capabilities for underprivileged segments and train covid long-hauling in conscientiously using new technologies.249 5. online education prospects covid-19 revolutionized the education sector for digital learning and hybrid online solutions.250 with covid-19 requiring social distancing and long covid being a potential debilitation disability for younger population groups, education professionals had to rethink learning operations, teaching methods, and examination standards.251 with most university campuses around the world undergoing a speedy transition to online teaching and remote learning during the pandemic,252 it has become a certainty that hybrid learning and online classwork can be longer-lasting advantages that may also hold innovation potential to alleviate inequality. especially with information rising about the long-term 247. see julia m. puaschunder, dignity and utility of privacy and information sharing in the digital big data age, 5 int’l j. comm. & mgmt. rsch. 62 (2018). 248. andrea korte, new report calls for input from underserved communities in deploying ai for public health, am. ass’n for advancement sci. (sept. 14, 2021), https://www.aaas.org/ news/new-report-calls-inpu t-underserved-communities-deploying-ai-public-health [https://perma.cc/c6zs-qqce]. 249. puaschunder, supra note 246; puaschunder, supra note 148; see also julia m. puaschunder, revising growth theory in the artificial age: putty and clay labor, 8 arch. bus. rsch. 65 (2020). 250. corlatean, supra note 212. 251. id. 252. walsh, supra note 160. 92 indiana health law review [vol. 19:47 impact of covid-19 and variants spreading that are harder on younger populations, education will likely stay – at least in parts – socially distanced. for the education world, the devastating pandemic also brought along enormous innovation, flexibility, and inequality alleviation potential: disruptive technology use adopted in record speed during the pandemic will enable universities in the future to cater education to the whole world at low cost. online learning offers students flexibility without considering their location or timeframe to study in a particular country if no relocation or visa to enter the country to study is required. generation covid-19 lockdown and long-haulers now will likely continuously put pressure on universities to offer hybrid education in larger international network consortia. students from all over the world could thereby flexibly take courses in large international education hubs with participating institutions being far spread out around the world. the actual on-site work of universities and research institutions will likely be focused on research, while learning will more likely happen online in the virtual space. networks that allow sharing resources within a larger consortium of universities around the world and within different industries or governments will likely take over. virtual meetings will provide the luxury of guest speakers granting a truly international outlook. digitalization disruption may also become a vehicle for upward social mobility that opens access to elite education without the need for a visa and the financial means for relocation and housing. without these costs, students will also be free to study longer and put together more diverse curricula over time and across institutions. education of the future could thus become truly global, tailored to individual interests and needs, life-long and catered to current developments. online education can thereby become the great equalizer that international development has been searching for decades.253 future partnerships of the technology sector and universities could extend the spectrum of hybrid teaching in international educational consortia. global access to online education could become an international development transformation game changer. with the currently ongoing digitalization disruption requiring increasingly eskills and the labor market has become truly global in the digital economy, the time for sophisticated and individualized e-education appears to have come.254 access to virtual consortia will enable students to cherry-pick a personalized curriculum based on interests and independent from the physical locations. a new cadre of individualized and highly-specialized graduates could emerge after the pandemic that could select catered studies based on their needs and wants during different stages of their careers. for this model to work, institutional openness to collaborate on a truly global level has to be emphasized. the online teaching option will likely lead to market segmentation between high-end physical learning experiences and low-cost online experiences. the division between these categories will likely depend on the field of study. 253. corey robin, the pandemic is the time to resurrect the public university, new yorker (may 7, 2020), https://www.newyorker.com/culture/cultural-comment/the-pandemic-is-the-time-toresurrect-the-public-university [https://perma.cc/43hm-2ck9]. 254. jones & romer, supra note 210. 2022] generation covid-19 long-haul 93 bundling options could couple hybrid short-term physical learning with online learning.255 with covid long haulers sometimes experiencing waves of symptoms and/or chronic fatigue, our understanding of learning and testing at one moment in time will also have to give way to more flexible, mellow schemes of productivity and success.256 to cater and adjust to covid long haulers, the universities of tomorrow will have to find curricula and evaluation criteria to adjust for weaknesses, rest, recovery, and mental impediments lingering after an infection. disability awareness and compassion will become key elements and qualifications of future successful educational institutions, but also essential social skills one can pick up in flexible learning and testing schemes as a necessary future social skill for a future fruitful career. while the affordability of entering virtual educational spaces could become great equalizer through affordable education around the globe. at the same time, too many students acquiring degrees could lead to an education boom and degree inflation. this may lead – in the long run – to a discreditation of already-existing degrees or at least a two-tier system, in which some gained a real-world education and others fully virtual ones. online education must define the highest quality standards and monitoring control to compensate for the missing real in-person learning and on-campus networking. if students do not need to be physically present on campuses and given the covid long-haul risk, young adults may likely stay longer with their parents. a generation that can miss campus experiences may grow up with a different mindset than those who spent time around people of their own age. it may not be a bad thing to stay longer under the protection of older generations, as children of older parents have a propensity to be successful in educational settings and career-wise. but with generation lockdown, there is the risk of social isolation, heightened levels of depression and a generation scared of social contact in contrast to students who have had the real-world learning experience. lowering the cost of education also holds the potential to lift the educational debt that puts generation internship into a prison of debt from which they often cannot escape even long after graduation. virtual learning experiences may also free students from social-psychological burdens and problems created by peer pressure in an on-campus educational environment. introvert people are expected to actually benefit from virtual settings. in order to take advantage and seize the opportunity of online learning world, but also to avoid problems arising from virtual realities, society together may work towards flourishing virtual spaces that uphold a healthy online exchange grounded in mutual respect. ennobling learning ethics of inclusion will embrace diversity. overall, virtual online education offers to imbue more social upward mobility into education. digitalization holds the key to granting access to affordable education in all corners of the world and can 255. karen feldscher, covid’s future: from pandemic to endemic?, harvard gazette (aug. 12, 2021), https://news.harvard.edu/gazette/story/2021/08/what-will-it-be-like-when-covid19-becomes-endemic/ [https://perma.cc/lzu5-xfeq]. 256. id. 94 indiana health law review [vol. 19:47 become the long-waited-for means to convey the spirit of hope inequality on a global scale. c. social, healthcare and retirement reform 1. recognition of long-haul covid as a disability since the outbreak of covid-19, covid long-haul awareness has been growing steadily. in july 2021, u.s. president joseph biden and vice president kamala harris announced that some impaired long haulers would be recognized as disabled.257 in speedy response to the long covid pandemic, the united states office for civil rights of the department of health and human services in cooperation with the civil rights division of the department of justice have put forward guidance on long covid as a disability.258 joint guidance from the united states departments of health and human services and justice acknowledges that long covid can be considered a disability under the americans with disabilities act. long covid is also recognized as disability in regards to the anti-discrimination provisions in the rehabilitation act and the affordable care act.259 as the u.s. department of health & human services (“hhs”) explains, long covid can be recognized as a disability under titles ii (state and local government) and iii (public accommodations) of the americans with disabilities act (“ada”).260 in addition, section 504 of the rehabilitation act of 1973,261 and section 1557 of the patient protection and affordable care act apply.262 each of these federal laws is intended to protect individuals with disabilities from discrimination.263 these mandatory protections apply even during emergencies and cannot be waived.264 according to the hhs, long covid can be considered as a disability under the sections listed above if an impairment following an infection substantially 257. rubin, supra note 8; press release, president joe biden, supra note 54; cirruzzo, supra note 54. 258. guidance on “long covid” as a disability under the ada, section 504, and section 1557, u.s. dep’t health & hum. serv., https://www.hhs.gov/civil-rights/for-providers/civilrights-covid19/guidance-long-covid-disability/index.html [https://perma.cc/qh9d-qtrb] (last updated july 26, 2021). 259. lydia wheeler, long covid’s catch-22: too sick to work, yet not quite disabled, bloomberg l. (nov. 18, 2021, 4:00 am), https://news.bloomberglaw.com/health-law-andbusiness/long-covids-catch-22-too-sick-to-work-yet-not-quite-disabled [https://perma.cc/h5689lj3]. 260. guidance on “long covid” as a disability, supra note 258; 42 u.s.c. §§ 12101-12103, 12131-12189. 261. 29 u.s.c. § 794. 262. 42 u.s.c. § 18116. 263. guidance on “long covid” as a disability, supra note 258. 264. id. 2022] generation covid-19 long-haul 95 limits one or more major life activities. moreover, individuals with a record of such an impairment and persons regarded as having such an impairment also qualify as disabled.265 relevant major life activities include (but are not limited to) “caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, sitting, reaching, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, writing, communicating, interacting with others, and working. the term also includes the operation of a major bodily function, such as the functions of the immune system, cardiovascular system, neurological system, circulatory system, or the operation of an organ.”266 the hhs further advises that “[t]he term “substantially limits” is construed broadly under these laws and should not demand extensive analysis. the impairment does not need to prevent or significantly restrict an individual from performing a major life activity, and the limitations do not need to be severe, permanent, or long-term. whether an individual with long covid is substantially limited in a major bodily function or other major life activity is determined without the benefit of any medication, treatment, or other measures used by the individual to lessen or compensate for symptoms. even if the impairment comes and goes, it is considered a disability if it would substantially limit a major life activity when the impairment is active.”267 covid-19 long haulers are therefore “entitled to full and equal opportunities to participate in and enjoy all aspects of civic and commercial life.”268 this implies that businesses, state or local governments will have to “operate to accommodate a person’s long covid-related limitations.”269 “for people whose long covid qualifies as a disability, these changes, or ‘reasonable modifications,’ may include” access to goods and services, flexible timing and adjusted testing as well as granted assistance by human, animal, device and technology.270 the hhs guidance addresses only the definition of disability under these laws.271 the recently-issued guidelines do not fully “cover other definitions of disability or eligibility requirements such as those necessary to qualify for federal 265. id. see, e.g., 42 u.s.c. § 12102(1); 29 u.s.c. § 705(9)(b), (20)(b); 28 c.f.r. §§ 35.108, 36.105; 45 c.f.r. § 92.102(c). 266. id. 267. id. 268. id. 269. id. 270. id. 271. id., n.9. 96 indiana health law review [vol. 19:47 benefit programs under social security.”272 the full legal status and policy guidelines on long covid are currently formed and expected to be adjusted and fortified as society learns more about covid-19 and its long-term effect on human health, well-being and productivity. to qualify for social security disability insurance, a condition must meet the agency’s definition of a disability.273 under the ssa’s rules, the disabling condition or symptoms also have to have lasted, or be expected to last, for a year or result in death.274 a person who has limitations resulting from long covid and meets or is expected to meet the duration requirement, “could be found disabled if their limitations equal a medical listing or if the combination of those limitations and vocational factors prevent them from performing substantial gainful activity.”275 already now, literature emerges that claims that some of the covid long haul conditions are hard to prove, and insurers can still set limits on benefits awarded to disabled covid long haulers.276 protection from discrimination and the provision of public accommodations thus still leave many too sick to work without secured financial disability protection.277 to this day, long covid is not on the social security administration’s list of disabling medical conditions.278 so far, the nation’s biggest private long-term disability insurers also tend not to acknowledge that long covid can cause long-term disability.279 it appears problematic that some of the most debilitating symptoms or the infection are still hard to prove and there needs to be an associated functional limitation that impacts the ability to do a particular job or work in general.280 general problems are the relatively low acceptance rate of social security disability benefits claims – on average 66% of the claims were denied in the period between 2009 and 2018.281 it can also take three to five months on average for the social security administration to make a decision about pending claims.282 in addition, even if successful, the social security benefits are in general often economically ‘sticky,’ meaning too slowly valorized to adjust to inflation. in 2020, as the pandemic took hold, u.s. health insurance companies declared they would cover 100% of the costs for covid treatment, waiving copays and expensive deductibles for hospital stays that frequently range into the hundreds of thousands of dollars.283 but then in 2021, insurers have already 272. id., n.9. 273. wheeler, supra note 259. 274. id. 275. id. 276. id. 277. id. 278. id. 279. id. 280. id. 281. id. 282. id. 283. christopher rowland, the days of full covid coverage are over. insurers are 2022] generation covid-19 long-haul 97 started to cancel full covid care coverage during sickness and restore deductibles and copays that leave acute covid patients with enormous medical bills.284 so while large insurance companies waived cost-sharing for coronavirus care in 2020, it has sprung back in 2021 with most insurers having reinstated copays and deductibles for covid patients, in many cases even before vaccines became widely available.285 not only is the time of infection an inequality driver, there is also a lack of uniformity in covid insurance practices between insurers and regions, which opens an uneven burden between patients across the country, varying widely by healthcare plan and geography.286 according to the washington post, patients in the same hospitals and in the same icu units could be facing completely different financial burdens.287 with no federal mandate for insurers to cover all the costs for covid treatment, it remains at the discretion of insurers how much they support covid patients and long haulers.288 and the reintroduction of cost-sharing mainly affects people with private or employerbased insurance.289 private insurance coverage for covid long haulers is also insofar unstable as it can be approved at first but later cut off.290 documentation is also often hard to obtain in an overflowing healthcare system and long waiting periods for poorly understood long haul issues. with reference to historical precedents of the past, generation covid long-haul partially being recognized as a disabled group may result in increased spending pressures and reform needs of the social, healthcare and retirement systems on a large scale. 2. impact on retirement systems and financial markets: historical parallels when considering the relatively young age of the onset long-haul covid-19, which is currently estimated to be most likely during the ages of thirty to fifty with a peak around the early to mid-forties, the long-term impetus of this usually highly productive part of society being slowed and/or weakened will be substantial when considering the dimensions of widespread infections if covid turns endemic and the expected tax revenue from this age group’s working income over time.291 the fact that a significant proportion of the population will restoring deductibles and copays, leaving patients with big bills, wash. post, https://www. seattletimes.com/nation-world/nation/the-days-of-full-covid-coverage-are-over-insurers-arerestoring-deductibles-and-copays-leaving-patients-with-big-bills/ [https://perma.cc/m45x-3kb2] (last updated sept. 22, 2021). 284. id. 285. id. 286. id. 287. id. 288. id. 289. id. 290. wheeler, supra note 259. 291. davis et al., supra note 47; ed yong, long-haulers are redefining covid-19, atlantic (aug. 19, 2020), https://www.theatlantic.com/health/archive/2020/08/long-haulers98 indiana health law review [vol. 19:47 become long haulers and thus be inhibited in their labor force participation will very likely lead to a significant impact on social systems, especially retirement systems, and consequently financial markets. as an analogy for the current situation, there are historical precedents in the first half of the 20th century after world war ii, when social benefits and retirement schemes changed drastically in post-war european social democracies. since the outbreak of the coronavirus comparisons have been made to ‘war economies.’292 it was during the post-world war era that the funding schemes for the current social and pension system were set on a course in many war-struck countries in europe that lasts until today. there are essentially two models for retirement systems (regardless of whether they are public or private), namely the funded model and the pay-as-yougo (“paygo”) model. under the funded model, retirement savings are set aside for the future and typically invested in the capital market.293 in the paygo model, funds are paid out to beneficiaries at the same time as they are collected from the contributions of current workers. a key advantage of the paygo systems – at least from the short-term political perspective – is that funds are immediately available to meet urgent demands of populations, especially after crises or when there is an unexpected surge of population segments being in pressing need for welfare insurance payments. continental european countries – such as germany and france, to give two examples – historically introduced their retirement systems mainly as funded systems that would rely on savings dedicated to retirement. in the german pension system, which was set up in 1889, the funding principle never worked for extended periods. reasons for the failure of the funded system include world covid-19-recognition-support-groups-symptoms/615382/ [https://perma.cc/34pk-7s8z]; francis collins, breakthrough infections in vaccinated people less likely to cause ‘long covid’, (sept. 14, 2021), nat’l inst. health director’s blog, https://directorsblog.nih.gov/tag/long-haulers/ [https://perma.cc/km3j-mqxt]; doheny, supra note 44. 292. john cassidy, the coronavirus calls for wartime economic thinking, new yorker (mar. 16, 2020), https://www.newyorker.com/news/our-columnists/the-coronavirus-calls-forwartime-economic-thinking [https://perma.cc/e5eq-g8zk]; daniel susskind, the pandemic’s economic lessons, atlantic (apr. 6, 2020), https://www.theatlantic.com/international/archive/ 2020/04/lessons-wartime-economics-coronavirus-covid19/609439 [https://perma.cc/p7hf-s8vq] (discussing the analogy to the war economy and the strong interference of the government with private contracts, e.g. with the uk government effectively “underwriting almost the entire private sector through wage guarantees”); gary pinkus & sree ramaswamy, the ‘war’ on covid-19: what real wars do (and don’t) teach us about the economic impact of the pandemic, mckinsey & co. (may 14, 2020), https://www.mckinsey.com/business-functions/strategy-andcorporate-finance/our-insights/the-war-on-covid-19-what-real-wars-do-and-dont-teach-us-aboutthe-economic-impact-of-the-pandemic# [https://perma.cc/qfr4-nbqr]. 293. funded systems could be organized as a “defined benefit” systems, where the investment risk is borne by the system provider (e.g., an employer), or as “defined contribution” systems, where the investment risk is borne by the beneficiary (the employee and future retiree), who may be able to direct the funds in her personal account to specific investments. 2022] generation covid-19 long-haul 99 war i reparation payments after the treaty of versailles in 1919, the destruction of the capital stock by hyperinflation in the 1920s,294 the use of pension assets for public expenditures (especially by the nazis), and the damage inflicted on the german economy by world war ii.295 the 1957 west german reform transformed retirement into a comprehensive social benefit system that provided 60% of a retiree’s previous monthly income.296 thus, it reduced reliance on other financial sources, such as support from the family.297 a major reason for this transition of social welfare funding was that inflation had greatly diminished the value of private savings.298 moreover, the funded system was converted into a paygo system299 over objections, among others, from the financial industry.300 with the change of systems, pensions now came primarily from the contributions of current workers instead from a funded capital stock.301 this was politically advantageous because it allowed payouts to uninsured older workers and a substantial amount of refugees from eastern 294. see peter ahrend, pension financial security in germany, in securing emp.-based pensions 73, 75 (zvi bodie, olivia s. mitchell & john a. turner eds. 1996) (discussing how hyperinflation made retirement benefits important for employees because private savings were wiped out). 295. bert rürup, the german pension system: status quo and reform options, in soc. sec. pension reform eur. 137, 137 (martin feldstein & horst siebert eds. 2002); gordon l. clark, private pensions as partial substitute for public pensions in germany, in pension sec. 21st century 115, 115 (gordon l. clark & noel whiteside eds. 2003); see also peter a. köhler, entwicklungslinien der 100jährigen geschichte der gesetzlichen rentenversicherung: die zeit von 1891-1957, in handbuch der gesetzlichen rentenversicherung 51, 83 (franz ruland ed. 1990) (noting that the german retirement insurance system’s capital had been destroyed three times in 30 years in 1945). it has been suggested that the german system already had become a de facto paygo system because most of its assets were invested in german government bonds during the interwar period. axel boersch-supan & christina b. wilke, the german public pension system: how it was, how it will be, nat. bureau econ. rsch. 1, 4 (2004). 296. bernhard ebbinghaus et al., germany: departing from bismarckian public pensions, in varieties pension governance: pension privatization eur. 119, 125 (bernhard ebbinghaus ed. 2011). 297. hans günter hockerts, sozialpolitische reformbestrebungen in der frühen bundesrepublik, 25 vierteljahreshefte für zeitgeschichte 541, 562 (1977). 298. jens alber, germany, in 2 growth to limits 3, 23 (peter flora ed. 1986). 299. e.g., bernhard ebbinghaus, the changing public–private pension mix in europe: from path dependence to path departure, in varieties pension governance 23, 35 (bernhard ebbinghaus ed. 2011). 300. hans günther hockerts, entwicklungslinien der 100jährigen geschichte der gesetzlichen rentenversicherung, in handbuch der gesetzlichen rentenversicherung 93, 99 (franz ruland ed. 1990) (noting that banks and insurance companies felt strongly threatened); alber, supra note 298, at 106 (discussing opposition by liberals and banks). 301. ebbinghaus et al., supra note 296, at 125; see also boersch-supan & wilke, supra note 295, at 4. 100 indiana health law review [vol. 19:47 europe.302 a major concern was that the new system would obliterate the need for private savings and may even make them impossible because of higher deductions, and because there would no longer be any retirement wealth that needs to be invested.303 the reform may have helped prevent the emergence of a strong capital market in germany, given that funds were no longer available for occupational pension commitments.304 similarly, the funded french system ran into problems in the late 1930s because many new retirees did not have enough funds in their accounts to cover the minimum guaranteed pension.305 a proposal by the government was to reduce allocations to individual accounts in order to be able to pay the amount directly to current retirees.306 inflation and the economic crisis eroded the 1930 system’s funding basis, and the german invasion struck the final blow to funding.307 the vichy regime came to see the system as financially unviable308 and introduced the paygo system in 1941.309 besides the failure of the funded capital stock, the motivation for introducing the new system was, as in the subsequent german 1957 reform, the inclusion of workers who had not made significant contributions to pension accounts.310 the switch to paygo allowed the use of accumulated reserves to pay pensions to old workers.311 reforms after 1945 consolidated the 302. ebbinghaus et al., supra note 296. politically, it apparently also helped to keep west germany attractive as a target for east germans considering a defection to the west. see hockerts, supra note 297, at 571 (quoting chancellor konrad adenauer that “the federal republic should remain attractive for inhabitants of ‘the zone’”). 303. hockerts, supra note 300, at 100. 304. see markus roth, private pensions and corporate governance, soc. sci. rsch. network 1 (2012). 305. see anne reimat, histoire quantitative de la prise en charge de la vieillesse en france xixe – xxe siècles: les régimes de retraites, 35 économies et sociétés 1097, 1157 (2001) (explaining that, in the 1910s and 1920s, the funding principle applied to the contributions, while expenses were financed by the state). 306. f. netter, les retraites en france au cours de la période 1895-1945 (fin), 1965 droit social 514, 517 (1986). 307. yves bouthillier, 2 le drame de vichy 364 (1951) (“the war, the occupation and the loss of value of the franc in comparison to the mark led us rapidly but fatally to a monetary devaluation . . . the devaluation of 1936 should already have provoked the disappearance of the system.”). 308. id. at 364 (former vichy finance minister criticizing the funded pension system in his memoir); marek naczyk & bruno palier, france: promoting funded pensions in bismarckian corporatism?, in varieties pension governance 89, 96 (bernhard ebbinghaus ed. 2011) (discussing the failure of the system). 309. loi du 14 mars 1941 relative à l'allocation aux vieux travailleurs salaries. 310. reimat, supra note 305, at 1178 (attributing the general trend toward paygo in various parts of the french pension system to the inclusion of workers without a significant contribution history). 311. bouthillier, supra note 307, at 364-365; see also paul v. dutton, origins of the french welfare state: the struggle for social reform in france 203-04 (2002) 2022] generation covid-19 long-haul 101 paygo system,312 and prior bad experience with a funded system added to its subsequent popularity.313 in the middle of the 20th century, urgent needs of various crisis-struck population groups compelled both countries to convert their retirement system into paygo. politically significant groups and a large body of young voters had to be met, including relatively young war veterans, those impoverished after industry and economic shocks, stock market crashes and wars. across countries, the nature of these paygo systems meant that relatively few private funds were available for investment in capital markets. stock markets remained small throughout the second half of the 20th century, and firms financed themselves mainly internally through growth or bank loans where external finance was needed. research in political science, law, and finance shows that paygo systems have small capital markets and concentrated ownership structures.314 generation covid long-haul could have a similar impact on financial systems. the longer covid-19 persists and society is figuring out remedies to avoid, mitigate and adapt to the disease, the more people will classify for covid long haulers and the more pressure to provide substantial assistance and integration in society for them will mount. if a significant proportion of the productive population is unable to work, political pressure to find funding to provide a decent standard of living for these groups will invariably develop. organized interest groups of covid long haulers will arise, and this time social online media will likely play a significant role. the covid long-haul cohort spans different socio-economic groups, which means that large proportions of the electorate with different social backgrounds will likely sympathize with their plight. long haulers are typically relatively young and at an age where they will (discussing the vichy regime’s possible intent to gain the support of the working class). 312. ordonnance du 30 décembre 1944, ordonnance du 4 octobre 1945, ordonnance du 19 octobre 1945. 313. anne-marie guillemard, aging and the welfare-state crisis 53, 65 (2000) (quoting a supporter of the paygo as saying “[i]t is therefore absolutely vital to replace this system with a pay-as-you-go plan that allows the real resources to be shared constantly among all members.”); see also anne lavigne, pension funds in france: still a dead end?, 28 geneva papers on risk & ins. 127, 136 (2003) (suggesting the destruction of pension wealth in the 1930s left the french skeptical toward pension funds); kathryn l. moore, lessons from the french funding debate, 65 ohio st. l. j. 5, 25-26 (2004) (describing protests in 2003 to save the paygo system). 314. see marcel tyrell & reinhard h. schmidt, pension systems and financial systems in europe: a comparison from the point of view of complementarity, 47 ifo studien 469 (2001); peter alexis gourevitch & james j. shinn, political power and corporate control: the new global politics of corporate governance 213-21 (2005); martin gelter, the pension system and the rise of shareholder primacy, 43 seton hall l. rev. 909, 963-68 (2013); david s. scharfstein, presidential address: pension policy and the financial system, 63 j. fin. 1463 (2018). 102 indiana health law review [vol. 19:47 normally not yet have been in the position to save considerable amounts for their retirement. long covid is also more likely to occur in females, who account for over 70% of long haulers. like veterans, widows and refugees after world war ii, their decent standard of living will likely have to be provided for and/or substituted by the government out of funds generated by current workers. after world war ii, german economists endorsed the “mackenroth formula,” according to which current economic surpluses must cover all current retirement expenses.315 as the pressure to pay our funds to long haulers increases, this will also mean that fewer funds will be available for saving and investment instead of being transferred and paid out as they are generated. for retirement funding, social systems and financial markets the described potential funding scheme changes likely mean that there will be less saving to cover future expenses. productive, high-income earners will be more highly taxed, or a larger amount of funds will have to be diverted to government-run retirement systems, such as social security in the united states. in consequence, a smaller amount of funds will be available for personal retirement saving for these individuals. on the margin, amounts available for investment in the capital market will diminish, comparable to the situation in countries that opted for a paygo system after world war ii. the funding gap will depend on the number of long haulers in the population that leave the labor force permanently but also on the savings of long haulers. already now, many 401(k) plans contain only woefully inadequate amounts of savings.316 the market impact of covid-19, as well as the fact that many will withdraw money from pension plans early after the disruption of their livelihood,317 will likely mean that the percentage of workers with inadequate retirement savings will increase. females and minorities may be disproportionately negatively affected in the long run, while their savings dissipate in expected inflation and negative interest rate climates.318 in this process, median voter preferences will likely shift away from emphasizing the protection of shareholders.319 315. see hockert, supra note 297. 316. e.g., teresa ghilarducci & tony james, rescuing retirement: a plan to guarantee retirement security for all americans 3, 31-36 (2020); brian anderson, index reveals americans’ heightened worries around retirement, 401k specialist mag., (july 21, 2020), https://401kspecialistmag.com/index-reveals-americans-heightened-worries-around-retirement [https://perma.cc/8zn6-wx27]; gelter & puaschunder, supra note 16. 317. in addition, cares act § 2202 permits early distributions from retirement plans without a tax penalty under certain circumstances. 318. monique morrissey, the state of american retirement savings, econ. pol’y inst. (dec. 10, 2019), https://www.epi.org/publication/the-state-of-american-retirement-savings [https://perma. cc/kb5b-e48j] (noting the majority of black and hispanic families have no retirement savings); gelter & puaschunder, supra note 16. 319. see gelter, supra note 314, at 949 (discussing the political preferences for shareholder primacy of us voters); gelter & puaschunder, supra note 16. 2022] generation covid-19 long-haul 103 3. covid rescue packages and their economic impact a related issue is how funds that could be saved for the future will need to be channeled into present-day use. current governmental and governance covid rescue and recovery aid started since the united states economy fell into recession in february 2020 in the wake of the news over covid-19 and an evolving worldwide pandemic. since the onset of the economic crisis in the fallout of the pandemic, the u.s. federal government responded with extensive fiscal stimulus packages and emergency relief. the u.s. congress passed four special appropriations laws for the federal government to use in relief efforts, of which the largest was the coronavirus aid, relief, and economic security (“cares”) act, which provides approximately 2.08 trillion u.s. dollars in unprecedently highest governmental aid in north american history.320 these funds are directly or indirectly allocated towards industries and institutions that work on the recovery of covid-19 long haulers or re-integration into a newly emerging workforce post-covid-19. future generations are likely to be affected by the economic recovery after the covid-19 external shock – given the large amount of economic post-covid-19 rescue and recovery packages that are funded on debt.321 governmental efforts were coupled with the federal reserve taking monetary stimulus measures to stabilize and boost the economy in incremental interest rate cuts and discount rate drops down to 0.25%, and a federal reserve repurchase agreement interest rate of 0%.322 lending programs, loans and asset purchases were part of a 700 billion usd quantitative easing plan323 with repurchasing options, as well as bonds financing and regulation changes, which are all meant 320. coronavirus aid, relief, and economic security act (cares) act of 2020, pub. l. 116-136, § 4003(c)(2)(e) and (f), (3)(i)(i) and (ii). for a more radical position, see, e.g., matt stoller, five conditions for corporations about to receive coronavirus bailouts, promarket (mar. 17, 2020), https://promarket.org/2020/03/17/five-conditions-for-corporations-about-toreceive-coronavirus-bailouts/ [https://perma.cc/re7t-aaeq] (suggesting firms should no longer be allowed to make buybacks and not pay any dividends for five years). 321. gabe alpert, a breakdown of the fiscal and monetary responses to the pandemic, investopedia, https://www.investopedia.com/government-stimulus-efforts-to-fight-the-covid-19crisis-4799723 [https://perma.cc/8whp-z872] (last updated dec. 30, 2021); us business cycle expansions and contractions, nat’l bureau econ. rsch., https://www.nber.org/research/data/usbusiness-cycle-expansions-and-contractions [https://perma.cc/5h9e-b9d2] (last visited apr. 10, 2021). 322. jeff cox, the federal reserve just pledged asset purchases with no limit to support markets, cnbc (mar. 23, 2020), https://www.cnbc.com/2020/03/23/fed-announces-a-slew-of-newprograms-to-help-markets-including-open-ended-asset-purchases.html [https://perma.cc/s97qm5mp]. 323. jeanna smialek & neil irwin, fed slashes rates to near-zero and unveils sweeping program to aid economy, n.y. times (mar. 15, 2020), https://www.nytimes.com/2020/03/15/ business/economy/federal-reserve-coronavirus.html [https://perma.cc/wm2f-p758]. 104 indiana health law review [vol. 19:47 to stabilize the market and foster liquidity.324 the ongoing direct aid programs sum up trillions of u.s. dollars, of which 2.56 trillion were spent by the u.s. federal government as of march 31, 2021.325 four laws included an estimated 3.92 trillion u.s. dollars funding for credit, loans and loan guarantee programs.326 the cost of saving the global economy is estimated to have been 834 million u.s. dollars per hour for 18 months as of august 2021 alone.327 similar rescue and recovery efforts funded by bonds that will have to be repaid by future generations apply in european countries.328 the european union had a concerted eurozone monetary policy administered by the european central bank that faced constraints due to an already low interest rate regime.329 recovery plans included the pandemic emergency longer-term refinancing operations, currency swaps, increased lending and euro-denominated liquidity for central banks outside the eurozone to provide market stability and financial liquidity partially enacted via bonds in the 128 billion u.s. dollar range.330 the pandemic emergency purchase programme (“pepp”) purchased 800 billion u.s. dollars in 324. alpert, supra note 321; press release, bd. governors fed. rsrv. sys., federal reserve actions to support the flow of credit to households and businesses (mar. 15, 2020), https://www.federalreserve.gov/newsevents/pressreleases/monetary20200315b.htm [https://perma.cc/3h5r-5re6]. 325. usaspending, https://www.usaspending.gov/ [https://perma.cc/td7e-pk5j] (last visited apr. 10, 2021). 326. how is the federal government funding relief efforts for covid-19?, usaspending, https://datalab.usaspending.gov/federal-covid-funding/#fn1 [https://perma.cc/4y7t-x2cb] (last visited apr. 10, 2021). 327. thomasson & hirai, supra note 73. 328. angelo borselli & ignacio farrando miguel, corporate law rules in emergency times across europe, 2020 eur. co. & fin. l. rev. 274, 308-9 (surveying the uk, france, germany, italy, and spain). in addition, bank regulators around the world introduced limits on dividends and buybacks during the pandemic. see patricia kowsmann, european bank dividend ban lifted, but restrictions remain, wall st. j. (dec. 15, 2020), https://www.wsj.com/articles/european-bankdividend-ban-lifted-but-restrictions-remain-11608060995 [https://perma.cc/79yc-nlzh]. 329. alpert, supra note 321; monetary policy decisions, eur. cent. bank, https://www.ecb. europa.eu/press/govcdec/mopo/html/index.en.html [https://perma.cc/6una-c5u6] (last visited may 13, 2020). 330. alpert, supra note 321; press release, eur. cent. bank, ecb announces new pandemic emergency longer-term refinancing operations (apr. 30, 2020), https://www.ecb.europa. eu/press/pr/date/2020/html/ecb.pr200430_1~477f400e39.en.html [https://perma.cc/dvg6-lazl]; press release, eur. cent. bank, new eurosystem repo facility to provide euro liquidity to noneuro area central banks (june 25, 2020), https://www.ecb.europa.eu/press/pr/date/2020/html/ ecb.pr200625~60373986e5.en.html#:~:text=under%20eurep%2c%20the%20eurosystem%2 0will,central%20governments%20and%20supranational%20institutions [https://perma.cc/46dp9uxb]; monetary policy decisions, supra note 329; press release, eur. cent. bank, ecb banking supervision provides temporary capital and operational relief in reaction to coronavirus (mar. 12, 2020), https://www.ecb.europa.eu/press/pr/date/ 2020/html/ecb.pr200312~45417d8643.en.html [https://perma.cc/9ygh-sauq]. 2022] generation covid-19 long-haul 105 bonds and commercial papers throughout the year 2020 that will be expanded up to a total of 1.5 trillion u.s. dollars until the end of june 2021 in order to reach a total target of 2.24 trillion u.s. dollars.331 the european union’s concerted action to avert the economic downturns of the covid-19 pandemic in a common fiscal stimulus proposal funded by eurobonds triggered what experts already call the “next generation eu” that bring member states closer together in a fiscal union and stability solidarity pact.332 in addition to concerted european union action, the national governments of the eurozone countries passed fiscal and monetary policy acts in line with directives from the european central bank. germany enacted the – by far – largest fiscal stimulus and economic stabilization fund within the eurozone with liquidity constraint relief summing to around 950 billion u.s. dollars.333 monetary and fiscal policy measures similar to those conducted by the european central bank were introduced in france, italy, spain, austria and the nordic countries with several subsequent stimulus and relief packages as the covid-19 economic crisis unfolded. in general, european aid tends to strengthen the relatively more public administered healthcare system and union-protected workers throughout europe 331. alpert, supra note 321, monetary policy decisions, supra note 329. 332. alpert, supra note 321; matina stevis-gridneff, e.u. adopts groundbreaking stimulus to fight coronavirus recession, n.y. times (july 20, 2020), https://www.nytimes.com/ 2020/07/20/world/europe/eu-stimulus-coronavirus.html [https://perma.cc/477s-b7km]; shalini nagarajan, the european union's $826 billion stimulus plan to battle the coronavirus is ‘too small and too late,’ analysts say, bus. insider (may 30, 2020), https://www.businessinsider. com/whateu-826-billion-covid-19-stimulus-package-means-2020-5 [https://perma.cc/ggt8-7hjk]; jan strupczewski & kate abnett, eu leaders unblock 1.8 trillion euro budget, recovery fund, eye climate goals, reuters (dec. 9, 2020, 5:06 pm), https://www.reuters.com/article/us-eu-summit/euleaders-unblock-1-8-trillion-euro-budget-recovery-fund-eye-climate-goals-iduskbn28j37l [https://perma.cc/xkt8-hnwa]. 333. alpert, supra note 321; julia anderson et al., the fiscal response to the economic fallout from the coronavirus, bruegel, https://www.bruegel.org/publications/datasets/covidnational-dataset/ [https://perma.cc/rky4-4l89 ] (last updated nov. 24, 2020); press release, minister peter altmaier, minister altmaier: “unprecedented support programme for employees and enterprises” (mar. 27, 2020), https://www.bmwi.de/redaktion/en/pressemitteilungen/2020/ 20200327-altmaier-unprecedented-support-programme-for-employees-and-enterprises.html [https://perma.cc/xv3f-jssx]; press release, fed. ministry of fin., federal government takes large-scale measures to tackle crisis fallout (mar. 23, 2020), https://www.bundesfinanz ministerium.de/content/en/pressemitteilungen/2020/2020-03-23-supplementary-budget.html [https://perma.cc/7kqs-h9jp]; bertrand benoit & tom fairless, germany boosts already hefty coronavirus stimulus, wall st. j. (aug. 26, 2020), https://www.wsj.com/articles/germany-boostsalready-hefty-coronavirus-stimulus-11598440184 [https://perma.cc/jsb3-kcxg]; factbox: germany's stimulus package helps consumers and companies, reuters (june 3, 2020, 6:44 pm), https://www.reuters.com/article/us-health-coronavirus-germany-stimulus-p/factbox-germanysstimulus-package-helps-consumers-and-companies-iduskbn23a3in [https://perma.cc/w6bpnc5y]. 106 indiana health law review [vol. 19:47 – for instance when thinking about the kurzarbeit model that allows for not laying-off workers during the pandemic but instead shortening their working hours.334 employee representation on the boards in germany and other european countries, or at least a structured relationship with unions as it exists in many countries, may have facilitated more conciliatory measures to protect workers while allowing firms to reduce cost by switching to shorter working hours.335 in addition, european governments tend to support households directly in addition to granting liquidity to businesses and social welfare. the united kingdom (“uk”) faced economic turmoil due to brexit and trade re-negotiations during the onset of the pandemic. the bank of england cut its benchmark interest rate twice to 0.1%336 and purchased governmental and nonfinancial, investment corporate bonds in the range of 567 billion u.s. dollars. 337 in addition, the bank of england initiated a scheme where it would extend credit to banks and take the bank’s loans to small and medium-sized enterprises as collaterals, thus creating incentives for banks to lend to such businesses.338 moreover, the british covid corporate financing facility (“ccff”) program sets out to purchase commercial papers from firms that committed to reducing their dividends and share buybacks, and it permitted banks to create a reserve called 334. jones et al., supra note 74 (graphically showing data provided by the international monetary fund). 335. jens dammann & horst eidenmüller, taming the corporate leviathan: codetermination and the democratic state, u. ill. l. rev. 1, 50-52 (forthcoming 2022). 336. alpert, supra note 321; monetary policy summary for the special monetary policy committee meeting on 19 march 2020, bank eng. (mar. 19, 2020), https://www.bankofengland. co.uk/monetary-policy-summary-and-minutes/2020/monetary-policy-summary-for-the-specialmonetary-policy-committee-meeting-on-19-march-2020 [https://perma.cc/d5mk-zudf]; bank of england measures to respond to the economic shock from covid-19, bank eng. (mar. 11, 2020), https://www.bankofengland.co.uk/news/2020/march/boe-measures-to-respond-to-theeconomic-shock-from-covid-19 [https://perma.cc/hwz9-f75q]. 337. alpert, supra note 321; update on the contingent term repo facility (ctrf) market notice 19 june 2020, bank eng. (june 19, 2020), https://www.bankofengland.co.uk/markets/ market-notices/2020/update-on-the-contingent-term-repo-facility [https://perma.cc/vz9v-qw8a]; asset purchase facility (apf): pricing of cbps eligible securities – market notice 5 june 2020, bank eng. (june 5, 2020), https://www.bankofengland.co.uk/markets/market-notices/2020/apfpricing-of-cbps-eligible-securities-june-2020 [https://perma.cc/j9w2-jdh3]; bank rate maintained at 0.1% june 2020, bank eng. (june 18, 2020), https://www.bankofengland.co.uk/monetarypolicy-summary-and-minutes/2020/june-2020 [https://perma.cc/9evk-8jww]; bank rate held at 0.1% and asset purchases increased by £150bn november 2020, bank eng. (nov. 5, 2020), https://www.bankofengland.co.uk/monetary-policy-summary-and-minutes/2020/november-2020 [https://perma.cc/x9gf-nsjb]. 338. alpert, supra note 321; bank of england, term funding scheme with additional incentives for smes (tfsme) – market notice, bank eng. (mar. 11, 2020), https://www. bankofengland.co.uk/markets/market-notices/2020/term-funding-scheme-market-notice-mar-2020 [https://perma.cc/w39z-a2yp]. 2022] generation covid-19 long-haul 107 “counter-cyclical capital buffer”339 to aid liquidity in the banking sector.340 the uk fiscal stimulus comprises six packages totaling up to 18% of the british gdp.341 the size, scope and dimensions of covid-19 rescue and recovery plans are unprecedented and account for the historically largest concerted effort of action to avert the negative economic fallout from an external economic shock.342 in confronting the crisis and evaluating international and governmental rescue packages, the size of rescue and recovery aid has gained widespread attention for potential negative consequences, such as long-term debt and inflation.343 governments around the world that strengthened their position as crisis managers and financial aid planners during the pandemic may now use their newfound powers to address other issues.344 strengthened command-and-control powers after covid-19 may persist beyond the virus crisis. crisis alleviation expertise may be used to combat other societal threats and concerns besides covid-19, such as inequality, social injustice and climate change but also tackling a healthcare crisis in covid long haul sufferers. already now, the iconic governmental coronavirus rescue packages and bailout aids are being used to implement system change towards an arguably more just and environmentally friendly society.345 the covid-19 governmental shock therapy implied that governmental aid is either directly channeled to pro-social causes or targeted at strategically setting positive market incentives. governmental crisis management may also use its regrown authority and the corporate dependency on public emergency funds and rescue bail-out packages to set incentives to implement environmental degrowth 339. alpert, supra note 321; bank of england, hm treasury and the bank of england launch a covid corporate financing facility (ccff), bank eng. (mar. 17, 2020), https://www. bankofengland.co.uk/news/2020/march/hmt-and-boe-launch-a-covid-corporate-financing-facility [https://perma.cc/zfp6-pquf]. 340. alpert, supra note 321; huw jones & david milliken, bank of england cancels stress test of banks over coronavirus, reuters (mar. 20, 2020), https://www.reuters.com/article/ushealth-coronavirus-britain-regulation/bank-of-england-cancels-stress-test-of-banks-overcoronavirus-iduskbn2170qi [https://perma.cc/45v2-a8mv]; press release, bank. eng., hm treasury and bank of england announce temporary extension to ways and means facility (apr. 9, 2020), https://www.bankofengland.co.uk/news/2020/april/hmt-and-boe-announce-temporaryextension-to-ways-and-means-facility [https://perma.cc/62vx-dyh6]. 341. alpert, supra note 321; magdalena szmigiera, value of covid-19 stimulus packages in the g20 as share of gdp 2021, statista (nov. 19, 2021), https://www.statista.com/statistics/ 1107572/covid-19-value-g20-stimulus-packages-share-gdp/ [https://perma.cc/me42-4wdx]. 342. thomasson & hirai, supra note 73. 343. brunnermeier, supra note 22. 344. e.g., nicholas mulder, the coronavirus war economy will change the world, foreign pol’y (mar. 26, 2020, 6:29 am), https://foreignpolicy.com/2020/03/26/the-coronavirus-wareconomy-will-change-the-world/ [https://perma.cc/3mvy-6y93] (among other things, speculating that governments might use their emergency powers to combat climate change). 345. monck, supra note 66. 108 indiana health law review [vol. 19:47 as outlined in the green new deal (“gnd”) or foster a sustainable finance taxonomy as promoted in the european green deal.346 making the governmental grants dependent on certain conditionalities may also allow governments to direct firms to address the climate change challenge.347 the gnd may thereby serve as a broad-based market solution to implement global environmental and pro-social governance as “the sum of the many ways individuals and institutions, public and private, manage their common affairs.”348 the potential focus of bailouts and recovery ranges from an urban-local and national focus to even global and futureoriented beneficiaries, as pursued in public investments promoted in the green new deal or european green deal sustainable finance taxonomy.349 on a shorter time horizon, the massive amount of funding holds enormous potential to alleviate inequality that may stem from or have deepened during the covid-19 crisis, such as in the previously described financial market versus real economy gap. but also, industry-specific inflation patterns as well as urbanversus-rural disposable income differences in the wake of ambitious bailout and recovery plans should be considered when choosing bailout targets wisely to uplift those with a disproportionate burden.350 as blatantly visible among covid long haulers, the remission potential being age-dependent but also the gender propensity to become a covid long hauler being skewed towards females puts a disproportionately heavy burden on specific societal cohorts and gender groups. transfer payments between covid winners and losers but also redirection of funds for those in need based on a legal disparate impact analysis will hopefully be at the core of international covid rescue and recovery. in the evaluation and monitoring of these unprecedentedly large amounts of governmental stimulus, economic bailout and rescue packages, socio-economic attention should also be paid to the intergenerational inequality entailed in leaving a massive wave of debt to future generations.351 the rescue and recovery funds based on bonds funded via debt may also include future welfare targets to steer 346. gelter & puaschunder, supra note 16. 347. these could be used for investments in clean energy innovations, for instance, such as decentralized energy grids enabled via solar panels or ecologically-harmonious infrastructures in the sharing economy. see mariana mazzucato, the entrepreneurial state: debunking public vs. private sector myths (2015); the economics of climate, 56 fin. & dev. 1 (2019); the impact of investing, n.y.c. mun. water fin. auth., https://www1.nyc.gov/site/nyw/ investing-in-nyw-bonds/the-impact-of-investing.page [https://perma.cc/55w5-h5hn] (last visited jan. 11, 2021). 348. gelter & puaschunder, supra note 16, at 616. 349. symposium, confronting crisis: preparing for the unexpected, ohio st. bus. l.j. (2021). 350. julia m. puaschunder, on the social representations of intergenerational equity, 4 oxford j. fin. & risk persp. 4, 78-99 (2015). 351. id.; see also julia m. puaschunder, intergenerational equity: corporate and financial leadership (2019); julia m. puaschunder, global responsible intergenerational leadership: a conceptual framework and implementation guidance for intergenerational fairness (2017). 2022] generation covid-19 long-haul 109 positive market change over time with fruition coming to life after our generation. focus on future beneficiaries lies at the heart of the green new deal and the european green deal. as the social welfare innovation of our times, the middle agers of today longing for rest and recovery may be funded by future generations. in lieu, future world inhabitants may inherit a favorably stable climate thanks to dramatic market changes and lifestyle shifts towards harmony with the environment our generation has taken in the eye of recovering from a global pandemic.352 4. impact on healthcare markets in alleviating the covid-19 long-haul crisis, interdisciplinary viewpoints could also integrate the widespread impact covid-19 will likely have on healthcare. the trend toward vaccinations reducing the risk of severe covid-19 infection trajectories but also information exchange online about long-haul symptoms persisting after mild infections may shift future medical attention to focus on chronic diseases instead of just treating acute consequences. precautious medical intervention through vaccinations focused on a highly complex and fragile individual immune system could also be extended with insights about the unspecific immune system.353 the current societal discussion and policy intervention makes it apparent that society is vulnerable when reducing the potential for diversification.354 in light of the fact that viruses constantly mutate, a wide range of remedies need to be developed in the future, including tools to detect viral loads and precautious interventions in the environmental setting. a symptom-centered approach often does not cure the underlying chronic disease. focusing merely on treating symptoms and/or suppressing the body’s immune response to treat autoimmune diseases, which some long haulers are experiencing, implicitly produces unnecessary suffering.355 individual health, monetary and social costs occur when individuals wait with prevention until symptoms flare up or autoimmune imbalances cause damage to healthy parts of the body. but also, global costs for medication rise as large amounts of co2 and environmental pollution occur because of drug development. medication may also become ineffective if widespread population resistance against its effects builds up. persistent drug use from an early age may also cause organ impairment, drug addiction and a respective number of chemical residues in the groundwater. long-term effects of a novel virus and physical stress impacting chronic 352. see sergey orlov et al., green bonds, transition to a low-carbon economy, and intergenerational fairness: evidence from an extended dice model, int’l inst. for applied sys. analysis 1 (2018); jeffrey d. sachs, climate change and intergenerational well-being, in the oxford handbook of the macroeconomics of global warming 248-259 (lucas bernard & willi semmler eds. 2014). 353. interdisciplinary, multimedia conference, supra note 12. 354. id. 355. id. 110 indiana health law review [vol. 19:47 diseases compounded by rapid climate change will likely lead to a rethinking of medical care. attention will be paid to the environmental impact on health, but also vice versa the effect of healthcare on the environment. holistic salutogenesis could help find a well-rounded understanding of why environmental stressors may cause long-term debilitation in chronic diseases. living in harmony with the external environment could be integrated into the strengthening of recovery medicine in the aftermath of the covid-19 crisis. in all of this, the covid-19 pandemic may herald a legal and regulatory revolution for the general healthcare and well-being of people in line with the biological limits of a fragile planet. in addition to focusing on symptom relief, already now there seems to be an appreciation of emphasizing alternative treatments promoted in long hauler online survivor corps support groups.356 as discussed in section 3.2.4, a trend towards life-long prevention and holistic medical care with respect for the power of a healing harmony with the environment are likely to follow. the next revolution in healthcare may feature a ‘greening’ of lifestyles in healthy nutrition as holistic preventive care that can have faster individual results than large-scale economic greening projects, such as outlined in the united states green new deal and the european green deal.357 governmental approaches that target large-scale industry redefinition or a future planned greening of industries, such as the planned transition from heavy industries to renewables, can thereby be complemented by broad-based individual lifestyle changes that matter not only to individuals becoming free of covid long-haul symptoms caused by external stressors and environmental irritation, but also on its larger dimension in the social compound and over time to future generations.358 for instance, human eating habits and nutrition choices make up an estimated 30-40% of the co2 pollution if the combined regionality, seasonality and food waste are all taken into consideration.359 5. law & economics of rest, recovery, and minimalism as for a scientific system change, the field of economics is dominated by the aim to maximize profits with a focus on financial wealth accumulation. health – as the topic of our time – has gained unprecedented attention that will likely grow as the numbers of long haulers swell. with broad-based infection of an endemic virus and with its long-term impetus, covid-19 could become a means to redefine health and well-being as a primary goal of the economy, ecology and politics.360 356. see yang yang et al., traditional chinese medicine in the treatment of patients infected with 2019 new coronavirus (sars-cov-2): a review and perspective, 16 int’l j. biological sci. 1708 (2020). 357. barbier, supra note 197; pargendler, supra note 197; letter from members, earthworks, supra note 197; a european green deal, supra note 201. 358. interdisciplinary, multimedia conference, supra note 12. 359. id. 360. id. 2022] generation covid-19 long-haul 111 given that the estimated majority of long haulers (around 70-80%) are currently believed to be female, but also taking into account that about one third of all long haulers’ symptoms come in waves during debilitating covid longhaul episodes;361 the future analysis of macroeconomic aggregates and policy impacts is likely to reflect a more diversified, gender-sensitive and temporal view of social preferences under unpredictably changing conditions. in all of these prospective trends, the 21st century may turn out to be an unprecedented time of dis-economics that values everything contrary to the neoclassic idea of economics guiding on productivity, maximization and efficiency striving.362 neoclassical axioms of business, finance and economic research have a limited understanding of health and well-being.363 traditional economic growth theories considered capital and labor as essential push factors for every economy.364 exogenous growth theory is centered on exogenous shocks. new technology innovations or natural crises – such as pandemics – are captured as major drivers or downturns of economic growth. economic theory tries to measure the impact of economic driver triggers and exogenous shocks on capital and labor productivity.365 endogenous growth theory draws attention to dynamic interactions between capital and labor but also endogenous growth derived from ideas, innovation and learning.366 growth concepts were opened up for innovation generated in productive group interaction and learning in teams inside firms, learning-by-doing while performing tasks and learning-by-using of new technology.367 361. davis et al., supra note 47; yong, supra note 291; collins, supra note 291; doheny, supra note 44. 362. puaschunder, supra note 46. 363. id. 364. see evsey d. domar, capital expansion, rate of growth, and employment, 14 econometrica 137 (1946); sir henry roy forbes harrod, an essay in dynamic theory, 49 econ. j. 14 (1939); nicholas kaldor, a model of economic growth, 67 econ. j. 591-624 (1957). 365. nicholas kaldor, capital accumulation and economic growth, in the theory of capital 177 (f.a. lutz & d.c. hague eds. 1961); see also robert m. solow, is the end of the world at hand? 16 challenge 39 (1973); robert m. solow, a contribution to the theory of economic growth, 70 q. j. econ. 65 (1956); robert m. solow, technical change and the aggregate production function, 39 rev. econ. & stat. 312 (1957); trevor w. swan, economic growth and capital accumulation, 32 econ. rec. 334 (1956). 366. see kenneth j. arrow, economic welfare and the allocation of resources for invention, in the rate and direction of inventive activity: economic and social factors (r.r. nelson ed. 1962); robert e. lucas, on the mechanics of economic development, 22 j. monetary econ. 3 (1988); luigi l. pasinetti, structural change and economic growth: a theoretical essay on the dynamics of the wealth of nations (1983); paul m. romer, increasing returns and long-run growth, 94 j. pol. econ. 1002 (1986); paul m. romer, endogenous technological change, 98 j. pol. econ. 71 (1990); hirofumi uzawa, optimum technical change in an aggregative model of economic growth, 6 int’l econ. rev. 18 (1965). 367. see philippe aghion & peter howitt, a model of growth through creative destruction, 60 econometrica 323 (1992); philippe aghion & peter w. howitt, endogenous growth 112 indiana health law review [vol. 19:47 the outbreak of the novel coronavirus heightened attention to hygiene and healthcare. applying exogenous growth theory, the health risk exposure to the exogenous shock of covid-19 differs between employees, firms, industries, environments, and countries. health of labor capital but also a risk-free working culture and environment are expected to become essential features of a vital workplace. precaution, exposure, and long-term health care are also industry specific. all these variables will likely become new determinants of countries’ comparative advantages that overall drives economic growth in a covid-19struck economy.368 in endogenous growth theory terms, team hygiene and group monitoring of the collective health status but also learning-to-preventing holds future economic growth potential.369 applications of growth models adjusted to covid-19 should also include inequality of growth in the digital age, which will likely rise as the covid recovery will be digitalized.370 one can therefore hope for an economic renaissance that will emerge after covid-19 with a focus on the economics of health and well-being. preventive care and productivity will likely become subject areas that gain attention. in light of covid-19 long-haul episodes of rest and recovery as well as debilitation changing erratically and unpredictably, economics could also inform a more diversified and individual intertemporal discounting function. behavioral insights on how to navigate a turbulent world with attention deficits and under uncertainty about health status conditions may become fundamental for developing an idea of the economic benefits of rest.371 preferences for minimalism will likely gain popularity in a turbulent world longing for recovery. in the distribution of covid-19 relief, a system change may be accomplished when being guided by the interdisciplinary insights of ‘law and economics’ that in particular can address the disparate impact of the disease in order to derive targeted inequality alleviation strategies. as interpreted by the federal courts, a violation of title vii of the civil rights act, which prohibits employment discrimination, may be shown by establishing “that an employment practice or policy has a disproportionately adverse effect on members of the theory (1998); neville francis & valerie a. ramey, is the technology-driven real business cycle hypothesis dead? nat’l bureau econ. rsch. 1 (2002); robert e. hall & charles i. jones, why do some countries produce so much more output per worker than others?, 114 q. j. econ. 83 (feb. 1999); siegfried sharma, learning by using: the learning of a new language, rsch. ass’n interdisc. stud. 123 (2020). 368. gelter & puaschunder, supra note 16; david ricardo, on the principles of political economy and taxation (1817). 369. see julia m. puaschunder, economic growth in times of pandemics, proc. consciens conf. on sci. & soc’y 1 (2020). 370. the next normal, supra note 206. 371. oliver burkeman, escaping the efficiency trap—and finding some peace of mind, wall st. j. (aug. 6, 2021, 11:12 am), https://www.wsj.com/articles/escaping-the-efficiencytrapand-finding-some-peace-of-mind-11628262751 [https://perma.cc/zaz8-q9nj]. 2022] generation covid-19 long-haul 113 protected class as compared with nonmembers of the protected class.”372 thus, formally neutral employment policies may be considered discriminatory in effect, even if discrimination is not intended by the employer. with a generation of covid-19 long haulers affecting age and gender groups differently, being more likely occurring in thirty to fifty-year-old females, one could draw inspiration from the concept of disparate impact. while long haulers are not as such a protected class, certain demographic groups, particularly middle-aged females, appear to be more likely affected by covid-19 in the long run. employment policies that affect those afflicted with propensities for developing long haul covid more than others could indirectly violate the disparate impact standard. for instance, if employers order returns to workplaces, this could imply a disproportionate risk and impact on the likelihood to develop covid long haul for middle-aged females. the density and likelihood of being exposed to the virus may also play a role in particular human contact-facing industries. future economic policy research should be informed by legal expertise on the disparate impact, which could open up the black box of the neoclassical aggregate economic functions calculus as a measure of economic growth. the combined expertise of law and economics in their unique interaction may shed light on disparate impacts of disease, public health and economic relief measures. this may lead to an interdisciplinary framework for crisis alleviation through redistribution that in combination can set the course for a better future in a more compassionate and inclusive world. iv. outlook toward future research and policy we have argued that covid-19 as a ‘polycrisis’ results in long-term societal changes that can broadly be summarized in a drive to preventive healthcare and a more whole-rounded recovery spectrum, digitalization aiding to fill human gaps, as well as deurbanization into agro-hoods with closeness to nature. the socio-economic impetus of a long-haul wave on the general healthcare, workforce and the overall societal socio-economic system in the decades to come will likely boost real-time self-monitoring of the personal healthcare status, flourish eco-wellness nutrition lifestyle change trends and require a reorganization of social welfare systems and rethinking of an economic appreciation of deurbanization, rest and calm in corporate conduct and economic calculus. on the legal level, long covid-19 may result in class actions against employers or those responsible for ‘superspreader’ events. disability status claims, as well as healthcare and pension reform needs will arise in light of the relatively young age of long haulers being focused on recovery and rest rather than economic productivity, which may change productivity and tax revenue substantially. artificial intelligence, robotics, and big data insights to fill productivity gaps in humans with brain fog and cognitive impairment that comes and goes in waves are likely coming advancements to well-roundedly aid and 372. e.g., e.e.o.c. v. sambo's of georgia, inc., 530 f. supp. 86, 92 (n.d. ga. 1981). 114 indiana health law review [vol. 19:47 integrate long haulers in society. the rights of vulnerable populations turning to online social forums to discuss their impairment problems will have to be defended in the years to come as these citizen scientists sacrifice privacy and put themselves at risk of manipulation and discrimination. the envisioned future online forums to discuss and interact must be designed with caution, connecting us for collective information exchange fueled by emotional participation in common platforms that uphold dignity in privacy and appreciation for a respective communication culture. the beauty of enjoying lavish network effects and delving into world-wide collective emotional feasts also bears a responsibility to worship our common virtual luxury temples together wisely, conscientiously, and sustainably. big data in the healthcare sector should only be used with caution, such as in targeted information releases, to avoid discrimination. for instance, only anonymized data slices should be made available to the public in order to prevent stigmatization and discrimination based on predictable prevalence propensities within population groups or certain living areas. taxation of data transfer revenues will grant the fiscal space to offset losses and the social costs of market distortions caused by new technologies taking over human tasks and entering the workforce in the medical marketplace. tax revenue would also aid in guiding citizens to become more self-determined, mature, and decisive about healthcare prevention in early-on education programs that sensitize the population about potential downsides of open information exchange online. preventative healthcare measures taken while still in a healthy state are cheaper and preferable to first symptom-centered emergency room treatment. prevention gives people long-term flexibility through self-chosen behavioral changes. the ongoing prevention revolution will also lead to a self-determined democratization of the health system in the global development of humankind. from an economics perspective, firms will have to become resilient to the crisis, and consequently engage in long-term conversations about prevention, health, and precaution with their workforce. the unevenly distributed effects of the crisis and the growing income gap between financial market profit opportunities and real-world payment bottlenecks have increased harmful behavior such as an unhealthy diet, medication abuse and drug consumption as well as socio-psychological suffering in population groups that were already weakened before the crisis. social inequality and the unequal effects of rising inflation and long-term low interest rates reinforce the desire for a fair social compound in harmony with the environment. the existing trends toward attention to inequality, social justice and climate change risk will accelerate the tendency toward a broadening of corporate purpose toward stakeholderism, which has already begun in the past years.373 this will especially come to life in high 373. see catherine c. langlois & bodo b. schlegelmilch, do corporate codes of ethics reflect national character? evidence from europe and the united states, 21 j. int’l bus. stud. 519-28 (1990); abagail mcwilliams & donald siegel, corporate social responsibility and financial performance: correlation or misspecification?, 21 strat. mgmt. j. 603 (2000); julia m. puaschunder, intergenerational climate change burden sharing: an economics of climate stability research agenda proposal, 16 glob. j. mgmt. & bus. 31 (2016); emanuele camiglio 2022] generation covid-19 long-haul 115 contagion risk industries and professions with exposure to masses of people that may spread the virus. the pandemic will change the way individuals consume in line with a more environmentally conscientious lifestyle aiding on sustainability, which will bottom-up influence the corporate world. with the covid-19 crisis having inspired millions of workers to chase meaning in work, the time for ‘passion economies’ has come.374 covid triggered widespread attention to a healthy and consumption-conscientious way of living. this also goes hand-in-hand with sustainability pledges as green food choices often meet the criteria of ecological and co2-friendly production. covid-19 increased the call for firms and institutional investors to pay attention to healthy lifestyles that foster prevention and help reduce the spread of the pandemic.375 with the wider stakeholder community paying attention to ethical considerations of the asset issuing entities, socially responsible investment and divestiture from environmentally-harmful actions will rise.376 corporations may also have to give in to stakeholder pressures advocating for corporations to serve the greater good and wider stakeholder community. socially responsible investment and carbon divestiture are effective corporate strategies against the backdrop of a warming globe. empirical research already found that corporate social engagement was associated with corporate financial performance and positively related to long-term investments via litigation risk minimization, branding and widespread community support.377 corporations that opt for early withdrawal may enjoy first-mover advantages in signaling pro-active ethical leadership in an already ongoing transition to renewable energy. in addition, such firms may qualify to issue climate bonds,378 thus reducing firms’ costs of capital allowing them to use the green finance taxonomy as a strategic, entrepreneurial move.379 further, corporations remaining et al., climate change challenges for central banks and financial regulators, 8 nature climate change 462 (2018). 374. david vallance, my pandemic pivot: how crisis inspired millions to chase meaning in their work, dropbox blog (aug. 31, 2021), https://blog.dropbox.com/topics/work-culture/mypandemic-pivot [https://perma.cc/67g5-rgf8]. 375. supra section 3.2.3. 376. ken little, the complete idiot’s guide to socially responsible investing: put your money where your values are (2008). 377. see tae hee choi & jinchul jung, ethical commitment, financial performance, and valuation: an empirical investigation of korean companies, 81 j. bus. eth. 447 (2008); sandra a. waddock & samuel b. graves, the corporate social performance – financial performance link, 18 strat. mgmt. j. 303 (1997). 378. these could be used for investments in clean energy innovations such as solar power and wind turbines, eco-friendly infrastructure and more research and development in clean energy and green technology. mazzucato, supra note 347; the economics of climate, supra note 347; the impact of investing, supra note 347. 379. julia m. puaschunder, when investors care about politics: a meta-synthesis of political divestiture studies on the capital flight from south africa during apartheid, 5 bus. peace & sustainable dev. 24, 29-52 (2015). 116 indiana health law review [vol. 19:47 in carbon-intensive unstable markets may suffer long-term losses in the wake of an overall economic market decline in carbon industries and may be exposed to future litigation risks for environmental damages that could have been avoided by fossil fuel divestiture. government bailout packages are likely to be financed over the long term by the historically lowest, never-so-long-low key interest rates. low key interest rates will continue to allow the capital market to flourish. but this is based on the cost of a weakening of the potential of the interest rate as a monetary policy tool, which the economist john maynard keynes described as a “liquidity trap.”380 the low interest rate policy brings along long-term external financing of past ideas, which impairs the flexibility of investors to finance future-oriented innovations and may hold back societal progress. low interest rates on savings accounts in the real economy keep people trapped in the debt financing of past dreams. household debt traps are causing massive psychosocial burdens. a so-called ‘deaths of despair’ trend is already noticed in the us for mid-career death spikes induced by alcoholism, drug use and suicide.381 the strong contrasts between covid-19 winners and losers as well as the deep gap between strongly-positive financial market developments and the negative performance of the real economy induced by lockdowns, which is currently exposing the real economy to a wave of private bankruptcies and liquidity bottlenecks, therefore call on governments around the world to reboot financial markets to return to be a service industry – to serve the real economy. in this sense, the generally low interest rate creates a situation that the financial world lives at the expense of the real economy. governance to overcome potential social friction – due to the strong polarization of financial profits sponsored by low key interest rate policy and the real economy financial constraints – points at taxing the covid-profit industries, especially digitization winners, which could create fiscal space for redistributing some of the economic gains to industries that clearly lose from covid-19. taxation of digitalized economic growth during our forced digitalization disruption could provide the necessary redistribution funds to back the liquiditydried real economy, which also faces exposure to liability risks of superspreader infection events and a propensity to higher human touchpoint frequency. governments can also bring back the financial world in the service of improving and stabilizing the real economy in a stricter separation between investment and consumer banks, which already began in the course of the regulations following the 2008/09 recession. central banks could offer diversified interest rates. low key interest rates for driving innovation and economic growth in the financial sector could refund higher interest rates for the real economy savings for consumers in order to avert socio-psychological frictions from individual over-indebtedness in households. online currencies, such as the currently planned european central bank digital currency, could help a transparent use of the currency over time to strictly divert interest rate profits and 380. keynes, supra note 134. 381. anne case & angus deaton, deaths of despair and the future of capitalism (2020). 2022] generation covid-19 long-haul 117 avoid arbitrage or interest rate swapping. mutual collateral insurance between the financial world and the real economy would also be possible in order to spread risk. bonds could be used to enable innovations, while repayments should be redistributed to the real economy. in addition, banks could be encouraged to use the current profits for future large-scale investments that add societal long-term value. for example, large construction projects but also innovation in research and development are valuable macroeconomic multipliers that can benefit society as a whole in the short and especially the long term.382 governments and intergovernmental bodies, as well as the european union as a supranational organization, have the long-term vision and financial freedom to operate on deficits but also the regulatory means to enact large-scale redistribution and long-term wealth creation in grand investments for the future. neoclassical ideas of business, finance and economic research are limited in their understanding of health and well-being. traditional economic growth theories considered capital and labor as essential growth factors for every economy. the outbreak of the novel coronavirus heightened attention to hygiene and healthcare. according to exogenous growth theory, the health risk exposure to the exogenous shock of covid-19 differs between employees, firms, industries, environments, and countries. health of human capital but also a riskfree working culture, environment, industry, and country will permit flourishing and growth in a covid-19-struck economy. in endogenous growth theory terms, team hygiene and group monitoring of the collective health status but also learning-to-preventing hold future economic growth potential. applications of covid-19 adjusted growth models should also include inequality of growth in the digital age. while standard economic cycle theories primarily focus on describing economic correlates of booms and busts, less attention is paid to socio-economic correlates and collective fallouts of inflation expectations and interest rate pressures. inflation has progressively entered the prevailing narrative among the people of our times.383 an expected longer-lasting inflationary pressure within society, corporations and consumers will also mean a long-hauling effect of a disproportionately heavy impact of inflation on the most vulnerable populations.384 further, we are currently experiencing the longest-ever period of a low interest rate regime. this fosters capital flow for innovation in the finance world, while it disincentivizes household savings and decreases private consumers’ resiliency. when it comes to the discussion of inflation induced in the economy by quantitative easing to pay for the rescue of the economy and uphold decent living conditions and social standards for everyone in an inclusive society, we have to acknowledge the differentiated effect of inflation on different social strata and subsequently following propensities of different social groups in order 382. keynes, supra note 134. 383. may research letter: the 3 pillars of inflation, crescat cap. (may 19, 2021), https://www.crescat.net/may-research-letter/ [https://perma.cc/z2s6-t45l]. 384. id. 118 indiana health law review [vol. 19:47 to alleviate the disproportionately heavy burden on marginalized groups.385 studying the multi-faceted influence factors on covid-19 long-haul fallouts may offer invaluable insights on how to avert and alleviate the negative impacts of covid on marginalized groups. the role of socio-economic correlates and socio-psychological fallouts from economic cycles, however, has not gotten enough attention in scholarship. likewise, policy proposals do not yet fully reflect these behavioral dynamics and interactive effects. this information is yet fundamental to understanding the collective moods in society during a crisis and the individual well-being adjacent to it that differs heavily between different social groups. the need to find a collective long-haul solution within the social compound and specific focus on disparate impacts of the crisis and its recovery on certain societal classes have not yet been recognized in the wealth of writings on federal reserve and central bank interventions, which range from fiscal and monetary policies, including interest rates to direct monetary stimulus such as quantitative easing. law and economics scholars and practitioners could fill this gap, which is currently also gaining attention from the covid long hauler survivor corps online. studying the effect of economic correlates to shape decisions about one’s own lifestyle over time and in the eye of prospective longterm life changing effects of covid-19 could be a fundamental impetus for future legal research, jurisprudence, and legal practice. all these endeavors will hopefully provide guidance on how to control future external shocks in humaneled responses that improve the overall well-being of society. in handling the crisis with respect for legal advancement, economic behavioral shifts and disparateimpact conscientious policymaking, this generation can establish a lasting legacy as a gift to future generations in the form of collective knowledge on how to overcome a global crisis wisely with social justice sensitivity and compassion. v. conclusion the novel coronavirus sars-cov-2 is an external shock to all world societies with lasting implications. given the size, scope and impetus of the pandemic that is expected to generate a wave of covid-19 long haulers as implicit agents of change, the crisis holds the potential to affect our world and modern society permanently. this article highlighted three prospective trends that will likely shape our future world to come. speculating about these potential changes lies at the core of navigating through a turbulent time with vigilance. after all, history offers a vital account of multiple records when crises, upheaval and periods of severe social and economic disruptions and their following recovery periods became essential turning points for lasting societal change and spring feathers of eventual betterment and comprehensive social advancement. 385. jacob passy, an inflation storm is coming for the u.s. housing market, marketwatch (july 13, 2021), https://www.msn.com/en-us/money/realestate/an-inflation-storm-is-coming-forthe-u-s-housing-market/ar-aakwtdx?ocid=msedgntp [https://perma.cc/snl8-d2sw]; cassim et al., supra note 20; press release, president joe biden, supra note 20. 2022] generation covid-19 long-haul 119 overall, capturing the contemporary trends and societal tendencies as well as their long-term consequences allows us to draw larger lessons for law, governance, and economic analysis. in the future, we may see a reconfiguration of institutions in many jurisdictions and a different understanding of health and well-being in the larger environmental context contributing to a more behaviorally informed economic profession. aspects of economic development – such as corporate governance – have often been analogized to biological evolution.386 as the shock of the pandemic had an immediate effect on all countries around the world, the long-term covid19 long-haul impact is likely to change the larger legal frameworks and economic environment but also societal structure of modern democracies for years to come. while corporate governance evolved gradually since world war ii in most western jurisdictions,387 covid-19 may trigger leaps in social and economic structures and institutions around the world that create a long run trajectory of system change. as long as long-haul symptoms persist in a growing body of previously infected, we are likely to see direct and indirect persistent effects in the future. in light of the potential of the coronavirus to create an endemic threat and a wave of long-term debilitated covid-19 long haulers, the governance and power dynamics in modern workplaces are expected to shift lastingly. attention to a healthy productive environment as well as long-term prevention and healthcare focus will likely become essential features of tomorrow’s corporate world. employers are already facing pressure to create a safe and secure working environment but are also concerned about liability risks considering potential long-term disability arising from unsafe working conditions. these economic and legal costs may be outsourced to outside agencies – such as insurers, healthcare consultants, the government or intergovernmental bodies, as well as the european union as a supranational organization. city scaping and modern inner architecture will become attuned to these preferences. firms may work closely with government regulators to adapt to changing trends. pro-active care for maintaining a healthy workforce and benefits that target the overall long-term well-being of employees including preventive care in teams, will become an essential corporate feature helping employers to attract qualified labor, whose bargaining power increases in the eye of labor shortages, especially in humanfacing industries and positions exposed to high levels of personal interaction. covid long haulers may help trigger an artificial intelligence revolution featuring self-monitoring and constant health status tracking. artificial intelligence, robotics and big data offer essential complements to fill in for longhaul attention and productivity deficits gaps that may occur in waves. decentralized healthcare information will undergo democratization as online selfhelp groups bundle information on individuals’ health status and discuss potential remedies free from bribery and corruption or market distortions. this trend will likely put patients and medical professionals on a more equal footing when 386. gelter & puaschunder, supra note 16. 387. id. 120 indiana health law review [vol. 19:47 discussing diagnoses and treatment. easier access to information will offer a cheaper alternative than seeking out doctors. decentralized information gathering online with fellow patients will also eliminate the danger of corruption and discrimination in access to medical information. equal access and online transparency will introduce an even greater level of quality control into the medical profession as already existing. crowdsourcing of remedy options will also likely extend the overall range of recovery aid options for both preventative and therapeutic healthcare. at the same time, large-scale online information exchange about medical conditions and potential remedy alternatives are rather novel phenomena and therefore hardly regulated. online crowdsourcing of information also opens gates to critical biases against those publicizing their health status online, as well as a risk of deception and fraud committed to a highly vulnerable population. online sharing of sensitive information opens privacy concerns for a vulnerable and impaired group. this necessitates the creation of legal and regulatory frameworks to prevent abuse of online forums for marketing purposes at the expense of the well-being of susceptible patients and impaired individuals in physical and emotional pain or debilitating conditions. long-term deliberations and hyperbolic discounting should be integrated into academic and political debates in order to protect individuals when innocently sharing medical information and compassionately seeking or extending non-medically trained help. generation covid long-haul partially being recognized as disabled creates pressure to reform social, healthcare and retirement systems. given waves of debilitation in a crisis-struck world, in which larger inequality gaps opened, the time for a disparate impact analysis of public policies has come in order to strategically focus rescue and recovery aid. legal and economic endeavors of the future should establish guidelines for a more diversified reflection of contemporary trends in order to channel governmental rescue and recovery efforts to those in need at the right time. the field of law and economics can provide the necessary interdisciplinary viewpoints and synergy potential to evaluate the disparate impact of the crisis and its remedy efforts within society. public policy recommendations and implementation guidance should particularly emphasize contemporary and anticipated long-haul patterns and trends. in the wake of ambitious bailout and recovery plans, a law and economics view could highlight necessary disparate impact facets of the economic fallouts to a common crisis. the unequally distributed economic gains and losses resulting from the pandemic should become the basis of redistribution efforts. behavioral economics insights could aid in understanding the socio-economic and psychological disparate impetus of the crisis. only a diversified analysis with respect to race, age, gender, heritage, wealth, and income brackets allows choosing capital transfer targets strategically. all analysis and redistribution efforts should be driven by fairness mandates and guided with a long-term view in mind. as for scientific advancements, generation covid long-haul has the potential to imbue minimalism, rest and recovery as central axioms into a refocused economic calculus. behavioral insights and leadership theories may inspire economic theory and policy modelling for attention to well-timed minimalism, rest, and recovery. in the scientific community, there is currently a 2022] generation covid-19 long-haul 121 heightened concern overreaching tipping points and irreversible lock-ins regarding global warming. the direct consequences of climate change, such as severe weather disasters, are additional external stressors for a cohort longing for rest and recovery. both trends are interconnected and will likely be integrated into holistic preventive medicine models of the future. healthy nutrition changes resulting in a greening diet that is anti-inflammatory can also help achieve climate goals better than prolonged human physical suffering in the wake of chronic diseases, economic unproductivity of long-term debilitation and ecological overexploitation by enriching groundwater with excessive drug consumption waste. a humane and environmentally-friendly transformation – through the establishment of agro-hood ecowellness hubs that practice a healthy lifestyle together in a growing community of like-minded individuals will likely continue to thrive in the future. this soft transformation of society could become a more powerful wave than a shock therapy of industry transitioning for the sake of greening the economy that may lead to short-term bottlenecks, unemployment and social frictions on top of taking too long to catch the closing time window to act on climate change. regarding healthcare changes, a cadre of chronically debilitated and sick will lead to a drive to alleviate chronic diseases. already now, the united states congress approved 1.15 billion usd in funding over four years for the united states national institute of health to support research to understand and cure the prolonged health consequences of sars-cov-2 infections.388 among the symptoms investigated by researchers, chronic fatigue, headaches, shortness of breath and memory fog range among the top mentions of chronic covid-19 symptoms. by drawing public attention, the prevalence of these symptoms will likely create pressure to find remedies and generate compassion for those affected in society. immune system related research and attention to the unspecific immune response based on activation levels but also inflammatory misfunctioning in autoimmune diseases will likely gain a greater emphasis in science as well, when considering the current state-of-the-art knowledge on the long-term effects reported by covid long haulers.389 another trend of the post-covid world that will likely persist is the selfmonitoring and self-measurement of body functions. artificial intelligence support in monitoring and self-testing kits has gained unprecedented momentum in record speed during the covid pandemic. with the general population partially being concerned about visiting medical facilities as potential virus transmission points and in some cases having particularly asked to stay away from attending a hospital for care during the pandemic, new online consultation revolutions in telemedicine but also online forums have started, which are likely 388. francis s. collins, nih launches new initiative to study “long covid”, nat’l inst. health (feb. 23, 2021), https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nihlaunches-new-initiative-study-long-covid [https://perma.cc/j6nn-3pya]. 389. gina kolata, you’re missing microbes. but is ‘rewilding’ the way to get them back?, n.y. times, https://www.nytimes.com/2021/07/19/health/human-microbiome-hadzarewilding.html [https://perma.cc/a797-x3a7] (last updated july 22, 2021). 122 indiana health law review [vol. 19:47 to be continued after covid. a wave of long haulers following after patients suffering from acute disease will likely continuously exacerbate these trends. in the end, telemedicine can also spread access to affordable healthcare around the world and could become a game changer for international development. since the onset of the covid-19 pandemic, there has been a trend to relocate from large metropolitan areas to more rural ones for the sake of social distancing. in places closer to nature, people have reconnected with the environment during a crucial time in light of climate change. today, there is a heightened demand for climate stabilization featuring concerted mitigation and adaptation efforts. creative ecowellness communities pursuing a sustainable lifestyle may emerge as innovations of our time by paying tribute to health and well-being within the given natural constraints of our ecological limits. future cities may also see ecological pricing reforms that contribute to the trend toward environmentalism. active cityscape projects may feature strategies such as forestation or commercial plants to absorb co2 from the atmosphere but also behavioral changes.390 already now, we can identify a trend towards individualized cars and further behavioral changes will likely force transportation to become more hygienic and individualized.391 lastly, the cities of tomorrow will likely feature intergenerational conscientiousness in protecting older and low immune system risk groups from contagious diseases, but also protect covid long-haul risk groups among middle-aged females.392 corporate settings, industry demands, and economic growth will likely stem from attuning to these ecowellness trends and sustainable lifestyles in the future. in light of the elevated risk for females to become covid long haulers, employers could voluntarily become more willing to grant females more flexibility for home office workplace solutions and digitalized interaction opportunities, or may be forced to do so by legal action, as they will take into consideration discrimination and long-term risk calculus. all these developments will likely enrich our post-covid society in a sustainable, healthy, and humane390. joão paulo braga et al., it could go like this, zeit (mar. 10, 2020), https://www.zeit.de/ autoren/b/joao-paulo_braga/ [https://perma.cc/r6kk-z8nn]; nikolaj skydsgaard, world's largest plant capturing carbon from air starts in iceland (sept. 8, 2021), https://www.reuters. com/business/environment/worlds-largest-plant-capturing-carbon-air-starts-iceland-2021-09-08/ [https://perma.cc/q6fe-z9yr]; agance france-presse, world’s biggest machine capturing carbon from air turned on in iceland, guardian (sept. 8, 2021), https://www.theguardian.com/ environment/2021/sep/09/worlds-biggest-plant-to-turn-carbon-dioxide-into-rock-opens-in-icelandorca [https://perma.cc/mgx9-tslw]. see also steven mufson, a climate change solution slowly gains ground, wash. post (apr. 19, 2019), https://www.washingtonpost.com/climateenvironment/2019/04/19/climate-change-solution-slowly-gains-ground/ [https://perma.cc/unv8m6bz]; ragnhildur sigurdardottir & akshat rathi, world’s largest carbon-sucking plant starts making tiny dent in emissions, bloomberg (sept. 8, 2021), https://www.bloomberg.com/news/ fea tu res /2 0 2 1 -0 9 -0 8 / in s ide -th e -wor ld-s -la rges t -d irec t -ca r b o n -c a p tu re -p lan t [https://perma.cc/5xgu-sewh]. 391. glaeser & cutler, supra note 119. 392. puaschunder, supra note 351. 2022] generation covid-19 long-haul 123 compassionate way. on a more global macro-economic level, the green new deal and european green deal as post-covid-19 recovery paths forward include sustainability pledges. a sustainable finance taxonomy may also innovatively include healthcare reforms and governmental funding of long-term health pledges in order to cater to a wave of covid-19 long haulers. attention to the integration of artificial intelligence into healthcare and medicine should be coupled with the insights of a cadre of those periodically suffering from long-haul symptoms. novel technologies come in handy in particular for those who wish to track their health in real time and those who have unstable conditions and are facing waves of symptoms and recurring disability. artificial intelligence could be integrated to provide support when patients face difficulty that may set on unpredictably and/or periodically. human-artificial intelligence compatibility will be key in navigating obscure symptoms and complex waves of multi-organ functionality deficiencies. big data insights will enable researchers and physicians to find patterns and clusters in waves of complex symptoms. in the future, the 21st century may well come to be seen as an unprecedented time of anti-economics that valued everything contrary to the neoclassic idea of economics of productivity, maximization, and efficiency. with this generation of covid-19 long haulers, who are around a median age in their 30s, 40s and 50s, a dramatic shift in demand for health, minimalism and rest is predicted to emerge. in particular covid long haulers appear to have a preference for unwinding speed and avoiding mental overload. while standard neoclassical economic theory is based on the belief that efficiency maximization stemming from productivity gains and activation level increases is the ultimate preference of all individuals, covid long haulers may develop – for the first time in economic history – a large-scale demand for attention to disability, rest and relaxation and thereby drive a trend of the economics of unwinding into slowness. in a generation of covid-19 long haulers, a dramatic demand for health, minimalism and rest is predicted to emerge. maximization of productivity driven industries in business, finance and economics do not account for minimalism. there is little appreciation for rest in finance and economics. foremost, behavioral economics started to address cognitive overload and decision-making failures in a too complex world for the human mind bound by cognitive overload. behavioral health efforts could address these trends of attention to health, minimalism and rest and cooperate with the covid-19 long haulers generation that may change society lastingly. legal professionals will address issues resulting from the presence of a growing cohort of long-haul sufferers in the workforce. drawing from behavioral insights, the laws of human productivity after rest will have to be better understood. the same is true for differences in time discounting over life stages. the role of critical life events of a covid infection to lastingly change life perspectives and decision making will need to be better understood and more accurately described by sciences investigating the family, the workforce but also economic variables. with long haulers facing trends of changing health conditions, novel workforce uncertainty will become a topic of discussion for corporate governance and business contingency planning. flexibility and 124 indiana health law review [vol. 19:47 compassion will likely become the essential leadership qualifications in tomorrow’s workplace, in which long haulers are prone to face fast-paced symptoms and work capability changes. the newly imposed obligation of corporations to ensure a healthy work environment will likely remain in place after the pandemic and will be coupled with certain rights of employers to monitor and track the health status of the workforce as well as force vaccination and other prevention and precaution mandates upon workers. corporate management will have to become attuned to the health situation of employees and will likely divide capital into artificial intelligence and a more unpredictable human workforce with an appreciation for rest and relaxation. new activation studies will be needed and will have to be guided by behavioral specialists that identify the right balance between work and rest. these studies will likely be inspired by activation research such as the yerkes-dodson law, which predicts the individual activation level.393 similar research could capture the overall immune system status to determine individual potentials and avoid overstimulation of the immune response leading to potential work deficiencies and quality of life impairments after a covid infection. all these trends in the economics of unwinding, relaxation and rest will likely become major drivers of a new revolution in economics that shifts attention away from profit maximization, productivity, and speed to focus on minimalism, relaxation and rest. previously avoidable states of rest, inaction and unproductivity that were deemed as problematic will be seen as a desired luxury outcome. the maximization of minimalism is likely to become a trend that will change the way society produces, consumes, and gratifies. artificial intelligence and robotics could keep an economic growth level while human beings start focusing on relaxation and letting go. legal scholarship can add to this trend in carving out the borderlines of rest and recovery and establishing social norms in workspaces and protect from discrimination of resting individuals, but also in other contexts, such as public spaces, public transportation, and commercial settings. space for individualized healthcare monitoring and testing has already been demanded and will likely continue to gain further attention as we recover from the pandemic with a growing population that will need to engage in continuous healthcare status tracking. in view of the long-term effects of the coronavirus crisis and the growing climate change threats, a change in values will likely take place in the course of a modern renaissance that tackles the crisis of our lifestyles – if humans feel they have become detached from the environment and in light of our recovering bodies and fellow human longing for long-haul rest and recovery. the interdisciplinary field of law and economics is predestined to play a pioneering role in the governance of changing societal values that can bring about an improvement in social and cultural prosperity via the detour of a global crisis. law and economics of the future can harness a mental rebirth based on novel and exciting opportunities and positive societal advancements that come out of the 393. see robert m. yerkes & john d. dodson, the relation of strength of stimulus to rapidity of habit formation, 18 j. compar. neurology & psych. 459 (1908). 2022] generation covid-19 long-haul 125 crisis – such as preventive medical care, reconnection with nature but also digitalization perks and governance for all in the restructuring of financial markets and social welfare benefits. behavioral changes could include behavioral law and economics leadership in ‘nudges’ and ‘winks’ towards environmentally and intergenerationally-conscientiousness as easily-implementable sources to educate and change people’s choices for betterment without direct enforcement.394 all these developments structured by law and economics expertise can become the ultimately fundamental high culture revitalization that our common world recovering from the largest-ever external shock with long-haul impetus deserves. 394. puaschunder, supra note 240. the forgotten patient: a health provider's guide to providing comprehensive care for transgender patients nikki burrill* & valita fredland•• "{t]imes can blind us to certain truths and later generations can see that laws once thought necessary and proper in fact serve only to oppress. as the constitution endures, persons in every generation can invoke its princi­ ples in their own search for greater freedom. " -lawrence v. texas1 i. introduction ........................................................................................ 70 a. is transgender a mental health disorder? .............................. 71 b. sex, gender, and sexual orientation ........................................ 72 c. patients with intersex condition .............................................. 72 d. underrepresented populations of the transgender community ..................................................................................... 74 1. elderly transgender ............................................................. 74 2. transgender veterans ........................................................... 75 3. incarcerated transgender individuals .................................. 76 ii. the patients' rights in healthcare .............................................. 76 a. patients' rights ......................................................................... 76 b. transgender patients in health care ....................................... 78 ill. an emergency room visit ............................................................... 79 n. the evolution of sex and gender in american courts ........... 81 a. mt. v. j.t. ................................................................................ 81 b. littleton v. prange .................................................................... 82 c. in re heilig ................................................................................ 83 d. kantras v. kantras ....... ............................................................. 85 v. legal implications for transgender healtii care rights ...... 86 a. the federal government's failure to protect transgender patients from discrimination ......................................................... 86 1. americans with disabilities act (ada) ................................ 86 2. title vii of the 1964 civil rights act.. .................................. 87 a. ulane v. eastern airlines .................................................. 89 b. schroer v. billington ......................................................... 89 *j.d. candidate, 2012, indiana university robert h. mckinney school of law; b.a., 2009, indiana university kelley school of business. **adjunct faculty at indiana university robert h. mckinney school of law and associate general counsel and chief privacy officer at indiana university health; m.s., university of virginia, 1992; j.d., cornell university, 1991; b.a., mount holyoke college, 1987. 1. lawrence v. texas, 539 u.s. 558, 579 (2003). 70 indiana health law review [vol. 9:1 b. state laws affecting transgender patients and health care .................................................................................... 92 i. amendment of birth certificates ........................................... 92 2. amendment of medical records ........................................... 93 3. health care consent and advance directives ...................... 95 vi. recommendations for future transgender legal issues .•.•... 96 vii. recommendations for heal1h care providers ••...••...•..••....••... 97 a. adapt your intake forms and intake process .... ~ ...................... 99 b. a healthcare provider's actions and words .......................... 100 i. use of proper pronouns ..................................................... 100 2. a provider's approach before conducting an interview ... 101 3. the interview process ......................................................... 101 c. be knowledgeable on the health needs oftransgender patients ......................................................................................... 102 d. be knowledgeable about non-medical concerns of transgender patients ................................................................... 103 e. attend trainings/seminars dedicated to the needs of transgender patients ................................................................... i 04 f. gain experience working with transgender patients ............ 105 viii. conclusion .................................................................................... 1 06 i. in1roduction the purpose of this article is to provide information regarding the le­ gal context of health concerns for the transgender community and to help healthcare providers create a welcoming environment for their current and future transgender patients. furthermore, this article discusses guaranteed rights to all patients involving their medical treatment and the failures of these guarantees to trans gender patients. part ii discusses patients' rights in health care and the deprivation of these rights for numerous transgender patients when being treated in a health care environment part iii of this article will review the application of laws involved in common experiences by transgender patients in healthcare and evaluate legal issues that arise out of these experiences. some of these legal issues include amending birth certificates to represent identified gender of patients, marriage status of transgender people and surrogate status of a partner in transgender relation­ ships. part n reviews case law particular to the evolution of the definition and interpretation of the terms "sex" and "gender" in the american court system. part v reviews statutes, both federal and state, that are relevant to transgender patients. finally, p~ vi provides recommendations for healthcare providers to provide the same standard of health care to all pa­ tients, including trans gender patients, within the context of laws that do not yet offer equitable rights 2012] providing care for transgender patients 71 a. is transgender a mental health disorder? "'transgender' is an umbrella term that includes anyone whose gender identity and/or gender expression does not match society's expectations of how an individual who was assigned a particular sex at birth should behave in relation to their gender.'.2 the following are included under the transgender umbrella: pre-operative, post-operative, and non-operative transsexuals who may or may not use hormones; intersex individuals; per­ sons exhibiting gender characteristics and identities that are perceived to be inconsistent with their gender at birth, or gender non-conforming; persons perceived to be androgynous; transvestites; cross-dressers; or drag queens or kings. 3 male-to-female (mtf) is a common term used for those born bio­ logically a male and chooses to identify and express themselves as a female. conversely, female-to-male (ftm) is a common term used for those born biologically as a female and chooses to identify and express themselves as a male.4 there is much controversy among mental health professionals and the transgender community on whether transgender should be classified as a mental health disorder.5 according to the american psychology associa­ tion, "[a] psychological state is considered a mental disorder only if it caus­ es significant distress or disability.',(; many transgender people do not feel their gender is distressing or disabling, implying it would not constitute a disorder.7 significant obstacles for these individuals include finding afford­ able resources for counseling, hormone therapy, medical procedures, and finding the social support to feel comfortable expressing their gender pref­ erences, discrimination, lack of acceptance within society, and assault. 8 for payment of a claim, insurance companies such as medicare and medicaid require that a specific disorder be defined or specified by the international classification of diseases (icd) or the diagnostic and statistical manual of mental disorders (dsm-iv).9 gender identity disor­ der (old), also known as "transsexualism," is a medical diagnosis recog2. n.y. comp. codesr&reos. tit. 8, § 101-131 (2006). 3. transgender terminology, nat'l ass'n of 'fransgender equality, http:// transequality.org/resources/ncte_ transterminology.pdf (last visited mar. 28, 2012). 4. samuel lurie, identifying training needs of health-care providers related to treatment and care oftransgendered patients: a qualitative needs assessment conducted in new england, in 'fransgender health and illv prevention: needs assessment studles from transgender communities across the united states 93, 95 (walter bockting & eric avery eds., 2006). 5. answers to your questions about 'j'ransgender people, gender identity, and gen­ der expression, am. psychology ass'n, http://www.apa.org/topics/sexuality/transgender. aspx (last visited mar. 18, 2012). 6. !d. 7. id. 8. id 9. id. 72 indiana health law review [vol. 9:1 nized by dsm-n, which is the american psychiatric association's ency­ clopedia of official diagnoses. not every transgender person experiences gid or considers a medical transition.10 the standard clinically recom­ mended treatment for gid involves some combination of hormone therapy, sex reassignment surgery and real-life experience living in accordance with the patient's gender identity.11 b. sex, gender, and sexual orientation the definitions of sex, gender, and sexual orientation are becoming more commonly understood as distinct.12 sex generally refers to individu­ als' biological sex, determined by "genetic material encoded in chromo­ somes," which typically corresponds . with external genitalia and phenotype.13 in contrast, gender typically denotes social constructions un­ derstood as male or female or masculine or feminine.14 sexual orientation is distinct from both sex and gender, and although no one definition can be offered, it is generally understood as ''the apparent or actual inclination( s) of sexual or affectional interests or desires among humans toward members of the same sex, the other sex, or both sexes,"15 or the "erotic and/or affec­ tional disposition to the same and/or opposite sex."16 although there are literally hundreds of other definitions of sexual orientation in the literature, most of them are distinguished from $ex and gender and include some sort of affectional component, not limited to sexual conduct.17 therefore, not all transgender individuals identify their sexual orientation as gay, lesbian, or bisexual.18 c. patients with intersex condition it is a common assumption to mistakenly believe that a person born 10. transgender rights toolkit: a legal guide for trans people and their advo­ cates, transition·related health care, lambda legal 2, http://www.lambdalegal.org/ sites/default/files/publications/downloadsltrt_transition-related-health-care_1.pdf (last visit­ ed mar. 18, 2012). 11. /d. 12. shawn m. filippi & edward j. reeve, equality or further discrimination? sexu· al orientation nondiscrimination in oregon statutory employment law after law after tan· nerv. ohsu, 3 j. small&emergingbus.l. 269,311, (1999). 13. john c. gonsiorek & james d. weinrich, the definition and scope of sexual orientation, in homosexualrry: research implications for public policy 1 (john c. gonsiorek&jamesd. weinricheds., 1991). 14. francisco valdes, queers, sissies, dykes, and tomboys: deconstructing the con­ jlation of "sex, " "gender, " and "sexual orientation" in euro-american law and society, 83 cal. l. rev. 1, 21 (1995). 15. /d. at 23. 16. gonsiorek & weinrich, supra note 13, at 1. 17. valdes, supra note 14, at 22-23 18. am. psychology ass'n,supra note 5. 2012] providing care for transgender patients 73 interesexed is the same as a transgender individual. this assumption, along with the incorrect assumption that a transgender person is also homosexual, is simply not true. "people who identify as transgender or transsexuals are usually people who are hom with typical male or female anatomies but feel as though they've been born into the 'wrong body. "'19 contrastingly, "[p ]eople who have intersex conditions have anatomy that is not considered typically male or female.'.2o both populations do commonly have similar medical treatments such as hormone therapy or sexual reassignment sur­ gery.21 the medical needs of interesexed individuals and the failure to fit into the binary construct of gender, creates legal gaps for interesexed indi­ viduals that are similar to those of transgender individuals. there are conflicting theories on how to clinically treat intersex ba­ bies. a majority of physicians in the united states believe that the standard practice is to ''normalize" the external genitalia of an intersex baby to con­ form to societal expectations of gender, also called the "concealment­ centered model.'.22 the concealment-centered model allows doctors to decide based on medical tests what gender identity they believe the child will find most comfortable. 23 doctors determine whether the child has a y chromosome and an adequate or ''reconstructable" penis, if so, the child will be assigned a male gender.24 for newborns, the baby must ha:ve a penis of 1 inch or larger to be assigned the male gender.25 if the child has a y chromosome and an inadequate or "unreconstructable" penis according to doctors, the child will be assigned a female gender and surgically "recon­ structed" as such?6 if the child has no y chromosome, it will be assigned the female gender.27 the genitals will be surgically altered to look more like what doctors think female genitals should look like, this may include clitoral reduction surgeries and construction of a "vagina.'.28 certain intersex activists have been promoting a competing treatment theory that states that a majority of procedures performed on intersex babies are for societal purposes and not for medical concems.29 this theory is called the, "patient-centered model. "30 the patient centered model sug19. what's the difference between being transgender or transsexual and having an intersex condition?, intersex soc'y of n. am., http://www.isna.org/faq/transgender (last visited mar. 18, 2012). 20. id. 21. id 22. /d. 23. shifting the paradigm of intersex treatment, intersex soc'y of n. am., http://www.isna.orglcompare (last visited jan. 16, 2012). 24. id. 25. ld. 26. /d. 27. id. 28. /d. 29. /d. 30. /d. 74 indiana health law review [vol. 9:1 gests individuals with intersex condition have a right to self-determination of their own bodies and should not be forced to undergo irreversible surger­ ies or treatments.31 the activists argue that "[d]ecisions regarding more permanent medical creation of sex attributes, including genital surgery, should be delayed until the child is old enough to participate in the decision along with family and medical professionals."32 like intersex individuals, the health care needs of smaller populations within the transgender commu­ nity can fall between the cracks when discussing the overall health care needs of trans gender patients. d. underrepresented populations of the transgender community like any population, the transgender community has segments that have been victims of additional discrimination. three sectors of the trans gender community typically not considered are 1) the elderly transgender, 2) transgender veterans, and 3) the incarcerated transgender. all three of these populations are particularly vulnerable either due to age, capability, limited health care coverage, or limits on freedom. both health care professionals and legal professionals should be cognizant of these un­ derrepresented populations in the transgender community and be responsive to their specific health care needs. 1. elderly transgender the needs of the elderly transgender are similar to those of the elderly non-transgender. these needs arise from the loss or death of a spouse or partner, decreased ability to maintain a private residence, loss of driving ability, transition from independent residence to an assisted living facility, and the loss of personal control.33 in the case of elderly transgender indi­ viduals, these challenges are compounded by issues regarding disclosure, privacy, isolation from transgender peers, specialized health care needs, and the potential for judgment and discrimination from health care profession­ als.34 medically, transgender elders face not only the normative problems of aging, but also, due to their hormone use and other procedures, increased health care needs.35 elderly that transitioned earlier in life have health con­ cerns relating to long term stress from living a significant amount of their 31. id. 32. jennifer rellis, please write 'e' in the box" toward self-ldenfitication and recognition of a third gender: approaches in the united states and india, 14 mich. j. gender & l. 223, 224 (2008). 33. see generally tarynn witten & stephen wittle, transpanthers: the graying of transgender and the law, 9 deakin l. rev. 504 (2006), available at http://www.deakin. edu.aulbuslawllaw/dlr/docs/vol9-iss2/vol9-2-l o.pdf. 34. id 35. /d. at 3. 2012] providing care for transgender patients 75 adult life as their identified gender.36 all of the issues faced by transgender elderly are further exacerbated when they are also a member of other minor­ ities such as race, ethnicity, immigrant, disability and/or having hiv/aids.37 "while living in nursing homes can be stressful for any elderly person, aging gay, lesbian, bisexual, and transgender (lgbt) americans are espe­ cially susceptible to abuse, neglect, and discrimination caused by homo­ phobia."38 "lgbt elders are more vulnerable because they are members of a minority group that is often subjected to emotional and physical hostility and they are often the first targets of abuse, neglect, and discrimination in nursing homes. "39 although case law concerning the discrimination against lgbt individuals in assisted care facilities is scarce, like many other as­ sisted care residents, these residents are still subjected to prevalent neglect and abuse.40 in a recent survey, lgbt respondents to a survey reported the greatest homophobia in nursing homes came from the staff, followed close­ ly by administration and other residents.41 for a majority of the population, an elderly lgbt individual does not come to mind when speaking of the lgbt population.42 therefore, this population of elderly individuals is not visible to the american population and is easily hidden, making them target of abuse and neglect.43 2. transgender veterans unfortunately, the legal road for transgender veterans includes a tur­ bulent history. currently, the veterans' affairs health system does not cover gender reassignment surgery or ''gender alterations for veterans.'m in a 2008 survey, a california research center found that transgender veterans felt they were disrespected and discriminated against while at veterans' affairs medical facilities.45 similar to stories from transgender patients at other medical facilities, transgender veterans were insulted when medical staff would not use the gender-appropriate pronouns while referring to the 36. id at34. 37. ld. at7. 38. jaime e. hovey, note: nursing wounds: why lgbt elders need protection from discrimination and abuse based on sexual orientation and gender identity, 17 elder l.j. 95, 95 (2009). 39. ld. 40. !d. at96 41. id. at 112. 42. id. at 100. 43. id 44. departments of veterans affairs, medical benefits package, 38 c.f .r. § 17.38 (2011). 45. rick maze, study: transgender vets face discrimination, air force times, aug. 25, 2008, available at http://www.airforcetimes.com/news/2008/08/military_ transgender _veterans_ 082508w/. 76 indiana health law review [vol. 9:1 trans gender veteran. 46 "trans gender veterans also complained that their privacy has been violated by medical staff, including one incident in which a nurse pulled a veterans' partner into the hall to ask if the partner knew that the veteran was born a man."47 3. incarcerated transgender individuals in addition to facing difficulties relating to health needs, transgender inmates are commonly targets of sexual, physical, and emotional assault.48 transgender inmates are routinely assigned housing not in accordance with the gender in which they identify.49 occasionally, correctional facilities find it appropriate to leave the transgender inmate in an isolation cell or block, leaving the inmate at a greater risk.ofsexual assault or rape.50 •'the u.s. supreme court has held that every inmate, regardless of gender identi­ ty, is entitled to reasonable medical care.',s1 52 unfortunately, due to tight budgets and the cost of travel for specialized surgeons, trans gender inmates' health care needs are met with high resistance from correctional facility administrations in the united states. currently, great britain and canada provide gender reassignment surgery to their prisoners. 53 refer to exhibit a for nine recommended principles for correctional health professionals to follow in providing for the needs of transgender prisoners made available by the national commission on correctional health care. 54 ii. the patients' rights in heal til care a. patients' rights a patients' bill of rights is a document that lists specific promises by an organization to patients when they receive medical care. in 1973, the american hospital association developed a patient bill of rights to inform patients of what they could reasonably expect while hospitalized and offer a way for hospitals to talk with patients about their care. 55 in 2003, an updat46. id 47. id 48. transgender health care in correctional settings, nat'l comm'n of corr. care, http://www.ncchc.org/resourceslstatements/transgender.html. 49. ally windsor howell, a comparison of the treatment oftransgender persons in the criminal justice systems of ontario, canada, new york and california, 28 buff. pub. int. l. j. 133, 145 (2010). 50. !d. 51. farmer v. brennan, 511 u.s. 825, 832 (1994), 52. howell, supra note 49, at 152. 53. howell,supranote49,at 177·179. 54. nat'l comm'n of corr. care, supra note 48. 55. patient's bill or rights, am. cancer soc'y, http://www.cancer.org!freatment/ findingandpayingfortreatment/understandingfinancialandlegalmatterslpatients-bill-of2012] providing care for transgenderpatients 77 ed version was published by the aha called, ''the patient care partner­ ship." both the 2003 and 1973 documents by the aha are not legally bind­ ing documents but were meant to be used as a guide for health care providers, patients, and organizations.56 some of the general patients' rights listed by the aha and other patients' bill of rights modeled after the aha include, high quality hospital care, a clean and safe environment, pa­ tient's involvement in care, protection of privacy, help with a patient's bill and filing of insurance claims, and preparing the patient and the patient's family for when the patient leaves the hospital.57 more recently updated patients' bill of rights typically include a right for patients to be treated with respect and non-discrimination, meaning patients have a right to be given respectful care from their doctors and other health care providers and to not be discriminated against based on race, ethnicity, national origin, religion, sex, age, mental or physical disability, sexual orientation, genetic infor­ mation, or source of payment. 58 59 after reading a patient's right to non-discrimination, it would be rea­ sonable to deduce that transgender patients would be free from discrimina­ tion based on either their sex or possibly their sexual orientation. this assumption would not be accurate. according to a 2010 survey of about 7,000 people by the national center for transgender equality and the na­ tional gay and lesbian task force called injustice at every turn, twenty­ eight percent of transgender or gender nonconforming people postponed medical care when they were sick or injured due to concerns about discrim­ ination and forty-eight percent of respondent postponed care because of inability to afford care.60 additionally, twenty-eight percent of respondents reported being victims of verbal harassment in a medical setting, and two percent were victims of physical.violence in a doctor's office.61 "many transgender people face a tremendous number of barriers when trying to access the healthcare system for day-to-day issues like a sore throat or a scrape of the knee, issues that somebody ordinarily can go to their doctor for without fear of discrimination or humiliation. '.62 the same survey found that nineteen percent of the participants reported being refused medical care due to their transgender or gender non-conforming status.63 it is important rights (last updated dec. 22, 2011). 56. patient care partnership, am. hosp., ass'n, http://www.aha.orgladvocacyissueslcomm.unicatingpts/pt-care-partnership.sh1ml (last visited jan. 16, 2012). 57. id. 58. am. cancer soc'y, supra note 55. 59. patient rights & responsibilities, indiana univ. health, http://iuhealth.orgl methodist/legal-notices/patient-rights-responsibilities/ (last visited jan. 16, 20 12). 60. jaime m. grant et al., injustice at every turn: a report of the national transgbnder discrjmination survey 6 (2011 ), http://www.thetaskforce.org/downloads/ reports/reportslntds _full. pdf. 61. ld 62. michael silverman, issues in access to l(ealthcare by transgender individuals, 30 women's rts. l. rep. 347, 348 (2009). 63. grant et al., supra note 60. 78 indiana health law review [vol. 9:1 to recognize that discrimination towards· transgender people occms in healthcare facilities, regardless of non-discrimination policies.64 "it is not necessarily intentional discrimination, but rather the result of a system that has never stopped to ask how we can address ·the needs of this popula­ tion.'.65 b. transgender patients in health care . according to transgender legal defense and education fund, a nonprofit organized to end discrimination based upon gender identity,66 many of its transgender clients face real, active hostility in the healthcare system based upon their gender identity. thus, it is not surprising that transgender people feel hesitant to seek help from medical professionals. in addition, a medical professional may diagnose the transgender patient's condition in­ stead of approaching the transgender patient's individual medical needs.67 for example, in the survey conducted in injustice at every turn, onere­ spondent stated, "i was forced to have a pelvic exam by a doctor when i went in for a sore throat. the doctor invited others to look at me while he examined me and talked to them about my genitals.'.68 it is not uncommon that transgender patients "are treated as 'specimens' and become the butt of jokes.'o69 whether intentional or not, healthcare professionals and other pa­ tients can find themselves guilty of offending a transgender patient with inadvertent actions such as leering. furthermore, a healthcare provider may inadvertently offend a transgender patient if the provider is hesitant when answering a patient's question. it is important for providers to be educated on the health needs of transgender patients and the legal context of healthcare for transgender pa­ tients. furthermore, providers, along with legal professionals, need to un­ derstand legal issues that can occur in a transgender patient's life outside of the healthcare environment, as these legal issues may have an impact on the health care provider's ability to provide care or the quality of care for the transgender patient. through cooperation, legal and healthcare profession­ als can help the transgender community achieve total healthcare inclusion. 70 64. /d. 65. silverman, supra note 62. 66. tldef: about tldef, 'i'ransgender legal def. & eouc. fund, http://www.transgenderlegal.org/page.php?id=2 (last visited jan. 16, 2012). 67. anne c. decleene, the reality of gender ambiguity: a rood toward transgender health care inclusion, 16 l. & sex. 123, 135 (2007). 68. grant et al., supra note 60. 69. id 70. /d at 125. 2012] providing care for 'fransgender patients 79 lll. an emergency room visit michelle and leonard have been married for approximately five years. leonard had a previous marriage of twenty-five years that ended in di­ vorce. 71 from that previous marriage, leonard has two adult children. three years after his divorce, leonard met michelle at a fundraiser for a mutual friend. leonard found in michelle a soul mate and best friend. while they were dating, michelle felt it was necessary to explain to leon­ ard her prior history of having been born biologically a male. michelle ex­ plained that throughout her childhood she had felt something was ''wrong" even during pre-puberty. she felt as if she was a girl with a ''birth defect" of penis and testicles. leonard was not concerned about michelle's past and felt they were meant to be together. leonard married michelle six months later. michelle worked as the store manager at a local flower shop. during a valentine's day rush at the flower shop, a man came to the store and opened fire on the employees and patrons. michelle was among two people shot during the incident, and was rushed to the local emergency room. as her husband and emergency contact, leonard was notified of the accident and met michelle at the hospital. the hospital staff met with leonard, who had identified himself as michelle's husband, to speak with him about emergency surgery to remove the bullet. michelle had been treated with pain medications, leading the surgical staff to feel that she was not capable to consent to any care. (note: the law for surrogate health care consent will be further explained later in this article.) leonard felt it was in michelle's best interest to have the surgery and gave his consent to the sur­ gical staff. the surgical staff began the procedure immediately. upon suc­ cessful completion of the procedure, the surgical staff discovered michelle was biologically born a male. the surgical staff was concerned that they were not notified of the patient's history prior to the procedure and became worried about leonard's legal standing to consent to michelle's surgery because the law does not recognize same-sex partner as a legal spouse and thus consequently neither a legal surrogate. meet joanne, a forty-two year old transgender woman, who was bio­ logically born as a male. 72 joanne has three young adult children and a wife named cindy with whom she had been married for fifteen years. joanne was biologically born a male and given the name jon. during childhood, jon was never comfortable with his body. jon always felt he was born the incorrect sex and would occasionally dress in women's clothing in private. jon never told anyone about his feelings because he was scared of his fami71. the following story was loosely based the facts of in re estate of gardiner, 273 kan. 191, 194 (2002) and other research. 72. the following story was inspired by our america with lisa ling: transgender lives (oprah winfrey network television broadcast feb. 22, 2011 ). 80 indiana health law review [vol. 9:1 ly and the community's reaction. furthermore, jon was confused about his feelings because while he felt he was a woman, he was attracted to females. jon felt it was best to ignore his feelings concerning his gender and attempt to grow-up like "any normal kid." in college, jon met his wife cindy dur­ ing his freshman year in their psychiatry class. jon and cindy got married the summer after their college graduation and had their first baby two years later. after raising three beautiful children, jon felt he could no longer ig­ nore his feelings and it was finally time to have a conversation with cindy. when sitting down with cindy, jon was terrified, like many transgender individuals are, when giving this news to a spouse, that cindy would leave him. jon was risking the loss of his wife, children, extended family, and even his job. however, jon felt he had lived over half of his life in discom­ fort and in a lie. as jon had feared, cindy was upset and distraught by the news that her husband had given her. jon told cindy that he was transgender and finally felt it was time for him to start living his life as a woman. after some time and consideration, cindy felt jon was her best friend of over fifteen years. she could not imagine her life without him. she had taken a promise to love and support him through all of their struggles. cin­ dy and jon decided to have a family meeting with their three children and explain to them that their father was transgender. like cindy, the children needed some time to process the new information. ultimately, the children were extremely supportive of their father. jon changed his name to joanne and, with the help of his wife and children, began living publicly as a wornan. after only two years of living publicly as a woman, joanne was in a dreadful car accident that caused her to visit the local emergency room. upon admittance to the emergency room, joanne was a victim of inappro­ priate whispers and leers by the hospital staff. although joanne was scared and in extreme pain, providers forced her to explain her physical appear­ ance by asking her uncomfortable questions during her exam. such unjust practices, although possibly without the intent to discriminate, can have devastating effects on transgender patients' comfort in going to healthcare facilities. strategies on how to avoid this problem in a healthcare facility will be addressed later in the recommendations section [insert section num­ ber]. another problem occurred upon cindy's arrival to the hospital. when cindy arrived in the emergency room and claims to be the wife of the transgender woman patient, do you question the validity of her marriage? what if joanne was unable to give consent to any life saving procedure that is needed, do you accept cindy's consent in substitution for joanne's con­ sent? like the earlier example of a transgender male with a biological fe­ male, joanne and cindy's situation raises many concerning questions about the marital and surrogate rights· of transgender spouses. regrettably, the 2012] providing care for transgender patients 81 answers to these questions are still unclear under the law. n. the evolution of sex and gender in american courts a. mt. v. j.t. the first meaningful precedent specifically referring to a transgender individual was in 1976 in the superior court ofnew jersey in mt. v. j.t. 13 the plaintiff, m. t ., was biologically born a male. 74 the plaintiff met the defendant and told him about his feelings of identifying as a woman her entire life. 75 after living together as a couple, the plaintiff consulted a phy­ sician about options for sexual reassignment surgery.76 the plaintiff even­ tually did undergo sexual reassignment surgery that was funded by the defendant.77 additionally, m.t. amended her birth certificate to demon­ strate her identified gender.78 subsequently, two years after the plaintiff's operation, the defendant decided to leave the plaintiff.79 the plaintiff filed suit for spousal support. 80 the court began its analysis by giving an overview of an english case corbett v. corbett.81 the corbett court found that a transsexual's gender was defined by their biological sex of the person at birth.82 the mt. court respectfully disagreed with corbett, finding there are "several criteria or standards which may be relevant in determining the sex of an individual.'.s3 the m t. court stated that: our departure from the corbett thesis is not a matter of semantics. it stems from a fundamentally different understanding of what is meant by "sex" for marital purposes. the english court apparently felt that sex and gender were disparate phenomena. . . . the evi­ dence and authority which we have examined, how­ ever, show that a person's sex or sexuality embraces an individual's gender, that is, one's self-image, the deep psychological or emotional sense of sexual iden73. m.t. v. j.t., 355 a.2d 204,205 (n.j. super. ct. app. div. 1976). 74. ld 75. ld 76. ld. 77. ld 78. id at 205. 79. jd. 80. jd. 81. id. at 208 (citing corbett v. corbett, (1970) 2 all e.r. 33 (u.k.)). 82. jd. (citing corbett v. corbett, (1970) 2 all e.r 33 (u.k.)). 83. ld. 82 indiana heal til law review [vol. 9:1 tity and character. 84 in a 1966 case brought by a transgender female seeking to obtain a court order to have her birth certificate changed to reflect her new gender, the court reasoned that it was in the public's interest to not allow a trans­ sexual to change her gender on her birth certificate because it protected against fraud. 85 the m t. court agreed with the following statement made by the dissenting trial court judge in weiner, who stated, "[t]he transsexual is not committing a fraud upon the public. in actuality she is doing her ut­ most to remove any false fa~e. "86 the m t. court held that if sexual re­ assignment surgery is successful and a transsexual's psychological gender and genitalia are in harmony, the court did not perceive any legal barrier or ground in public policy to prevent that individual from entering into a mar­ riage. 87 the court in m t. found that the plaintiff was a female at the time of the marriage and the defendant was obligated to pay spousal support to the plaintiff. 88 b. littleton v. prange in 1995, a texas court of appeals disagreed with mtv. j.t. when it heard littleton v. prange.89 in that case, a transsexual female named chris­ tie was born with male genitalia. 90 christie testified that she felt she was a female since she was three to four years old.91 at the age of nineteen and over the next for four years, christie took steps to transition genders includ­ ing the use of hormones, and psychological and psychiatric treatment by a physician.92 finally, christie underwent sexual reassignment slirgery at the age of twenty-three years old93 christie's treatment was conducted by a multi-disciplinary team of physicians that met regularly to interview and care for transsexual patients. 94 two of those physicians testified at trial that christie was medically a woman. 95 christie met a man named mark littleton, with whom she lived until the time of his death in 1996.96 upon littleton's death, christie filed a wrongful death claim against littleton's treating physician, as littleton's 84. ld at 209. 85. anonymous v. weiner, 270 n.y.s.2d 319 (n.y. sup. ct. 1966). 86. ld. at 210. 87. id. at 210-211. 88. jd. at 211. 89. littleton v. prange, 9 s.w.3d223 (tex. 1999). 90. id. at 224. 91. id 92. jd 93. ld 94. ld 95. id. 96. id. at 225. 2012] providing care for transgender patients 83 surviving spouse.97 the defendant filed a motion for summary judgment, claiming that christie, as a biologically born male, could not be the surviv­ ing spouse of littleton because same-sex marriage was not legal in texas.98 in its analysis the court also referred to biological analysis used in the eng­ lish case corbett v. corbett.99 using the corbett analysis, the littleton court found that chromosomes were not changed by use of either hormonal treatments or sexual reassignment surgery. 100 this allowed the court to hold that christie, a post-operative female transsexual, was still biologically a male, and since a male cannot be married to another male under texas law, christie's marriage to jonathon littleton was invalid. consequently, she did not have standing to bring a wrongful death suit as a surviving spouse.101 interestingly, the dissenting opinion in littleton relied on the rules of civil procedure and the burden of proof on the defendant102 to conclude that by permitting christie's birth certificate to lawfully be amended to show a corrected name and gender, texas had allowed for gender inaccuracies to be corrected. 103 the amended birth certificate reflected the original filing date, the original issuance date, and the amended issuance date. 104 "under the rules of civil procedure, a document that has been replaced by an amended document is considered a nullity."105 "[texas rules of civil pro­ cedure] rule 65 provides that the substituted instrument takes the place of the original."106 as a result, the dissent claimed the majority based its deci­ sion on a nullified document that should not have been considered and that summary judgment should not have been granted. 107 c. in re heilig in 2003, a maryland appellate court concluded in in re heilig that gender can be subject to modification or adjustment.108 the petitioner, robert heilig, was born as a biological male in pennsylvania109 and sought an order to change his name and gender in a maryland court to female. 110 attached to her petition were supporting letters from two health care pro97. /d. 98. /d. 99. /d. at 227 (citing corbett v. corbett, (1970) 2 all e.r. 33 (u.k.)). 100. /d. at 230. 101. /d. at231. 102. id at 233. 103. id 104. /d. 105. id 106. id 107. /d. 108. decleene, supra note 67, at 133. 109. in re heilig, 816 a.2d 68,69 (md. 2003). 110. /d. 84 indiana health law review [vol. 9:1 fessionals, an endocrinologist, overseeing heilig's hormone therapy, and a licensed social worker, involved in heilig's psychotherapeutic treatment as a transsexual woman.111 the circuit court of montgomery entered an order to change heilig's name on her birth certificate but refused to correct her gender on· the document, stating that "gender had physical manifestation and was not subject to change."112 the court of special appeals affirmed the decision of the lower court.113 upon appeal, the court of appeals of maryland found· that despite the supporting clinical letters presented by heilig, there was no medical evidence presented to the court regarding heilig's gender.114 more importantly, the court concluded that the lower court "erred in broadly concluding, apparently as a matter of law, that gen­ der was not subject to modification or adjustment. ,m when conducting its own research, the court stated, "[i]n the context before us, the terms 'sex' and 'gender' are not necessarily synonymous for all purposes, and indeed; the perceived distinction between them, to some extent, lies at the core of transsexualism.',116 "the term 'sex' is often used to denote. anatomical or biological sex, whereas 'gender' refers to a person's psychosexual individuality· or identity. "117 additionally, the heilig court recognized that the medical profession generally acknowledges certain clinical factors to determine a person's gender.118 the factors are as fol­ lows: 1) internal morphological sex, 2) external morphological sex, 3) gon­ adal sex, 4) chromosomal sex, 5) hormonal sex, 6) phenotypical sex, and 7) personal sexual identity.h9 the court cautioned that not all seven factors are relevant in all cases.120 the heilig court took the liberty to conduct thorough research on the subject matter of the case before them. after con­ sidering the application of the clinical gender factors, the court went even further, giving an overview of related issues such as sexual ambiguity at birth, intersex individuals, recent studies on transsexualism being related to conditions in the womb, current medical opinion on genitalia, recognition of transsexuals' right to marry in other countries, and birth certificate amendments in other jurisdictions.121 ultimately, the court remanded the case to the trial court to reconsider in light of the notable research by the court.t22 ill. !d. 112. id 113. id 114. id. at 87. 115. /d. 116. id at 72. 117. id 118. /d. at 73. 119. id 120. id 121. /d. at 73-79. 122. !d. at 87. 2012] providing care for transgender patients 85 d. kantras v. kantras in kantras v. kantras, a florida court of appeals in 2004 followed what is called the "common meaning of male and female . . . to refer to immutable traits determined at birth."123 margo kantras was born as a bio­ logical female. 124 margo changed her name to michael and underwent sex­ ual reassignment surgery. michael met linda, who was pregnant at the time by her previous boyfriend.125 linda was aware of michael's past sur­ geries and biological sex. 126 the couple filed for a marriage license, repre­ senting michael as a male. michael filed for adoption of linda's son, representing himself as linda's husband.127 then, linda gave birth to a daughter using artificial insemination and the sperm ofmichaej's brother.128 later, michael filed for dissolution of marriage and custody of both chil­ dren.129 linda answered, claiming the marriage was void, michael's adop­ tion of her son was against florida's ban on homosexual adoption, and linda's daughter was not michael's biological child.130 the trial court found that michael had successfully completed the full process of sexual reassignment and linda was fully aware of his sex reas­ signment at the time of the couple's marriage. 131 the trial court further stated that chromosomes are not the only factor in determining the sex of an individual and do not override gender or self-identity, meaning the marriage of michael and linda was legal. 132 the trial court relied heavily on the australian family court case, in re kevin. 133 134 the trial court had stated that the in re kevin court, "correctly states the law in modem society's ap­ proach to transsexualism."135 the district court of appeal of florida, how­ ever, agreed with kansas, ohio, and texas that an individual's sex is determined at birth.136 the question of whether post-operative transsexuals are authorized to marry a member of their birth sex was a matter left to the florida legislature.137 this holding made the marriage between michael and linda void. 138 the court further remanded the issue of custody to be 123. kantaras v. kantaras, 884 so.2d 155, 161 (fla. dist. ct. app. 2004). 124. !d. at 156. 125. ld. 126. id 127. !d. at 157. 128. ld. 129. id at 156. 130. id. 131. id. at 157. 132. id 133. in re kevin, 28 faro. l.r. 158 (austl. faro. ct. 2003). 134. see kantaras v. kantaras, 884 so.2d 155, 160 (fla. dist. ct. app. 2004}. 135. id. at 160. 136. !d. at 161. 137. !d. 138. id. 86 indiana healm law review [vol. 9:1 determined by the trial court under the determination that the marriage is void.139 as shown, there are conflicting definitions of "sex" and "gender" among the courts. several courts have taken the view of the kantras court by stating it is beyond the powers of the courts to determine the rights of transgender individuals and, rather, is only within the power of the legisla­ ture. courts can only interpret the statutes set out by the legislature. the thorough approach taken by the heilig court to conduct research on recent social studies and medical opinions, allows for legal definitions of "sex" and "gender'' to be in agreement with medically accepted definitions previ­ ously stated. if followed by future courts, the heilig interpretation would not only unite the medical and legal professions, but it would allow for more rights to transgender patients and protections from discrimination. v. legal implications for transgender heal1h care rights law strongly supports the traditional recognition of only "male" and "female" genders.140 yet, as the courts struggle to·define gender, it is clear it is not a straightforward matter.141 similarly, social norms have not yet settled on a commonly accepted way to define or label these individuals as previously assumed.142 such standards of society and the law on sex and gender have created legal implications and pitfalls for transgender individu­ als in a variety ofsettings, (e.g., employment, family law, h~lth care, etc.) and for the friends and family of the transgender individual. a. thf! federal government's failure to protect transgender patients from discrimination 1. americans with disabilities act (ada) the federal government does not protect transsexuals from discrimi­ nation because gender dysphoria and transsexuals are excluded from protec­ tion under the american with disabilities act.143 the ada protects americans from discrimination based on a particular medical condition by a private employer, insurers, and health care providers.144 the ada provides individuals with a claim of action against their employer's insurance com139. /d. 140. decleene, supra note 61, at 129. 141. /d. 142. /d. 143. gary s. mogel, j.d., employment handicap discrimination based on gender dysphoria (i'ranssexualism), 25 am. jur. 3d proof of facts 415 (20 11 ). 144. karl e. hong, categorical exclusions: exploring legal responses to health care discrimination against transsexuals, ii colum. j. gender & l. 88, 89 (2002). 2012] providjng care for transgender patients 87 pany to guarantee the company complies with the anti-discrimination provi­ sions of the ada.145 ''pragmatically-speaking, the ada definition of 'dis­ ability' is the only means by which people canreceive protection from discrimination."146 in the "definitions" section of the ada, the following clause explicitly excludes transgender individuals from protection under the ada: homosexuality and bisexuality-for purpose of the defmition of "disability'' does not include homosexu­ ality, bisexuality, transvestism, transsexualism, pedo­ philia, exhibitionism, voyeurism, gender identity disorders not resulting from physical impairments, or other sexual behavior disorders.147 as discussed earlier, gender identity disorder (gid), also known as transsexualism, has been recognized by the american psychiatric associa­ tion's encyclopedia of official diagnoses. this often leads to the argument made by some individuals that the ada should be altered to define gid or transsexualism as a ''disability."148 this argument is controversial in the lgbt community as transsexual activists have shown concerns~ gid as a disability will be used against them to prevent the transgender community from entering mainstream society as health and therefore equal.149 2. title vii of the 1964 civil rights act the provided case law involving title vii of the 1964 civil rights act and transgender plaintiffs, involve claims by transgender plaintiffs against employers for employment discrimination. typically, the discrimi­ natory action is alleged to have occwred when the transgender employee either decided to transition while currently employed or was discriminated against in the interviewing process.150 there have been successful cases brought by transge'nder employees by arguing that transgender employees are protected from discrimination under title vll of the 1964 ciyil rights act.tst the relevant section of the statute states it is unlawful for an em145. ld. 146. id. 147. americans with disabilities act of 1990, pub. l. no. 101-336, § 511, 1990 stat. 933 (1990). 148. hong, supra note 144, at 104-107. 149. id. 150. equal opportunity for individuals with disabilities, definitions, 42 u.s.c. § 12211(b)(1) (2011). 151. ilana gelfman, because of intersex: intersexuality, title vii, and the reality of discrimination "because of ... [perceived) sex", 34 n.y.u. rev. l. & soc. change 55, 56 (2010). 88 indiana health law review [vol. 9:1 ployer "to fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment, because of such individu­ al's race, color, religion, sex, or national origin."152 the statute [title vii] did not provide guidelines for proving these acts of discrimination; however, the courts, including the supreme court, have developed a large body of case law in the area and created re­ quirements for proving illegal discrimination of vari­ ous types in the workplace. it is the case law, rather than the statute, which sets out how a judge or ju­ ry should determine if discrimination has occurred "because of ... sex."153 recently, courts have begun to apply a more liberal interpretation of title vii's prohibition of sex discrimination with regard to transgender plain­ tiffs.154 title vii cases involving transgender plaintiffs have implications to health care because 1) health care organizations are employers and 2) transgender patients have an increased chance losing their jobs and there­ fore, their health insurance, which could interrupt any current treatments or therapies. first, we've been discussing transgender individuals as patients, but numerous transgender patients are also health care professionals. as transgender health care professionals, these individuals are employees; as such their employment status may be vulnerable if they decide to transition. further, health care organizations, as employers, should be aware of the current case law and trends in interpreting title vii as applied to transgender employees. second, health care professionals should be aware of the life stressors their transgender patients may endure such as losing their employment, and in turn their health care insurance, after beginning the process to transition to their self-identified gender. health care profes­ sionals should be prepared to assist transgender patients in obtaining alter­ native medical insurance or other means of financial support. lastly, the cases brought under title vii demonstrate a recent change by federal courts of interpreting the term "sex" within sexual discrimination claims to include discrimination against transgender employees.155 152. the public and welfare, unlawful employment practices, 42 u.s.c. § 2000e2(a)(l) (2012). 153. gelfinan, supra note 151, at 59--60. 154. see schroer v. billington, 577 f.supp.2d 293 (d.c. 2008); nuskey v. hochberg, 657 f. supp.2d 47 (d.d.c. 2009). 155. see schroer v. billington, 577 f.supp2d 293 (d.c. 2008); nuskey v. hochberg, 657 f. supp. 2d 47 (d.d.c. 2009). 2012] providing care for transgenderpatients 89 a. ulane v. eastern airlines the leading precedent cited by courts in regard· to the narrow interpre­ tation of title vii's prohibition of . sex discrimination, involving a transgender plaintiff, is the 1984 case of ulane v. eastern airlines.156 ulane was a licensed pilot with previous experience flying combat missions in vietnam for the united states army.157 after retiring from the military, ulane worked as a pilot for eastern airlines in 1968.158 ulane began iden­ tifying as a transsexual in 1979 and started a physical transition in 1980 with the use of hormones and sexual reassignment surgery.159 ulane was discharged from her employment with eastern airlines in 1981.160 after being fired, ulane filed a sexual discrimination claim on two counts, first alleging she was discriminated against as a transsexual and second, that she was discriminated against as a female. 161 reversing the trial court's deci­ sion in favor of ulane, the seventh circuit found that title vii does not protect transsexuals.162 the court stated, "a prohibition against discrimina­ tion based on an individuars sex is not synonymous with a prohibition against discrimination based on an individual's sexual identity disorder or discontent with the .sex into which they were born."163 b. schroer v. billington in 2008, the district court of columbia took a different approach by supporting the medical definition of sex and finding for the transgender plaintiff in schroer v. billington.164 the plaintiff, diane schroer, was a male-to-female transsexual.165 schroer applied for a position with the li­ brary of congress that required a security clearance.166 schroer was well qualified for the job as a graduate of the national war college, the army command, the general staff college, a master's degree, and twenty-five years experience in the u.s. army}67 while on duty, schroer held im­ portant staff and command positions in the armored calvary, airborne, special forces and special operations units, and was in combat operations 156. ulane v. e. airlines, inc., 742 f.2d 1081, 1083 (7th cir. 1984). 157. jd. 158. id. 159. /d. 160. id. at 1082. 161. /d. 162. /d. at 1084. 163. /d. at 1085. 164. amanda raflo, evolving protection for transgender employees under title vii's sex discrimination prohibition: a new era where gender is more than chromo­ somes, 2 charlotiel.rev. 217,240 (2010). 165. schroer v. billington, 577 f. supp. 2d 293, 295 (d.d.c. 2008). 166. /d. 167. /d. 90 indiana health law review [vol. 9:1 in haiti and rwanda. 168 before retiring, schroer was a colonel assigned to the special operations command with a top secret, sensitive compart­ mented information security clearance since 1987.169 prior to applying for the position, schroer was diagnosed with gender identity disorder and had been actively working with a licensed clinical so­ cial worker to successfully transition. during the interview process, schroer was given the highest score of all applicants by all eighteen interviewers.170 schroer was unanimously recommended for the position by the selection committee.171 schroer was offered the position, after the employer agreed to increase the salary to be comparable to schroer's current salary.172 schroer then accepted the job offer. 173 however, before the employer had completed and submitted the paperwork, schroer asked one of the inter­ viewers, charlotte preece, to lunch.174 schroer wanted to tell preece of his intention to transition to a fernale. 175 schroer felt the employer should be notified of his transsexuality be­ cause he was at the stage in his 'transition in which he would be presenting himself in public as a woman by wearing women's clothing.176 schroer went further to explain that after a year of presenting himself as woman full-time, he would be using his vacation time to undergo sexual reassign­ ment surgery, but the surgery would not interfere with his job require­ ments.177 after concerns were raised by preece, schroer assured preece that schroer's security clearance would not be influenced by his transition and if preece had any further questions she could refer to a professional provided by schroer.178 additionally, to mitigate any concerns by preece about schroer presenting himself as a woman, schroer showed preece three pic­ tures of schroer in professional women's attire. 179 unfortunately, despite schroer's efforts, preece felt the pictures depicted "a man dressed in wom­ en's clothing," although preece did not say this to schroer at the time.180 immediately following the conversation, preece began to lobby against hir­ ing schroer for the position and ultimately decided not to hire schroer.181 preece testified that she had some concerns about schroer's credibility to 168. jd. 169. jd. 170. jd. at 296. 171. jd. 172. jd. 173. id. 174. ld. 175. id. 176. !d. 177. jd. 178. jd. 179. ld. 180. jd. 181. ld. at 297. 2012] providing care for transgender patients 91 testify in front of congress and ability to maintain his security clearance.182 the court analyzed schroer's claim of improper termination by quot­ ing title vii of the 1964 civil rights act and stating that "the 'ultimate question' in every title vii case is whether the plaintiff has proven that the defendant intentionally discriminated against her because of a protected characteristic."183 the court found, 1) the library's reasons for refusing to hire schroer were "not its 'true reasons, but were ... pretext[ s] for discrim­ ination," and 2) library's conduct was sexual stereotyping or discrimination literally "because of ... sex" and violated title vii.184 the court applied its decision in price waterhouse v. hopldns/85 to determine whether sexual stereotyping had occurred in this case. in price waterhouse v. hopkins, a woman named ann hopkins won a sexual discrimination claim after she was refused admission as partner based on upon her sex and her actions not being in accordance with sexual stereotypes. 186 "[d]iscrimination against a plaintiff who is transsexual-and therefore fails to act and/or identify with his or her gender-is no different from the discrimination directed against ann hopkins in price waterhouse, who, in sex-stereotypical terms, did not act like a woman."187 "sex stereotyping based on a person's gender non­ conforming behavior is impermissible discrimination, irrespective of the cause of that behavior."188 the court further pointed out that discrimination based on sexual stereotyping may look similar to discrimination based on schroer's transsexuality, a condition which has failed to get protection by a majority of federal courts under title vll.189 nevertheless, the court states it did not matter ''whether the library withdrew its offer of employment be­ cause it perceived schroer to be an insufficiently masculine man, an insuffi­ ciently feminine woman, or an inherently gender-nonconforming transsexual."190 further, the schroer court found that schroer was "entitled to judgment based on a sex-based disparate treatment theory, in addition to the price waterhouse 'sex stereotyping' theory."191 "the court accepted schroer's argument that 'because gender identity is a component of sex, discrimination on the basis of gender identity is sex discrimination. "'192 while a majority of jurisdictions have not followed schroer's precedent regarding this interpretation of title vii, it seems to be gaining credibility 182. id. at 297-98. 183. id at 299 (quoting st. mary's honor ctr. v. hicks, 509 u.s. 502,511 (1993)). 184. id. at 300. 185. price waterhouse v. hopkins, 490 u.s. 228,251 (1989). 186. id. 187. schroer v. billington, 577 f. supp. 2d 293, 304 (d.d.c. 2008) (quoting smith v. salem, 378 f.3d 566,574-75 (6th cir. 2004)). 188. id 189. id. at 305. 190. id 191. raflo, supra note 164, at 166 (citing schroer v. billington, 577 f. supp. 2d 293, 305 (d.d.c. 2008)). 192. ld. 92 indiana health law review [vol. 9:1 in recent employment discrimination cases involving transgender plain­ tiffs.193 b. state laws affecting transgender patients and health care most legal issues affecting transgender patients in health care involve state laws such as those addressing amendment of birth certificates, ability of a transgender patient to marry, and surrogate health care decision-making on . behalf of incapacitated partners. these legal issues are significant . to health care because it can directly impact common health care patient inter­ actions such as informed consent. either in a parent-child relationship or a spousal relationship. furthermore, the ability of a transgender patient to amend his birth certificate could affect the accuracy of medical records or future treatment options provided by the healthcare provider. 1. amendment of birth certificates fortunately, courts have given more concrete decisions concerning the ability of transgender individuals to amend their birth certificates. the re­ sponsibility of maintaining birth and death records remains with state or local jurisdiction.194 surgical evidentiary proof has been required by all states that allow for the amendment of birth certificates.195 however, these states do not agree on the level of surgical proof required to amend a birth certificate.196 the varying standards give rise to the concern that one transgender individual would be granted an amended birth certificate in one jurisdiction but denied in another. for example, although not in writing, the state of new york and new york city strictly enforce different standards of surgical procedures.197 the state of new york requires proof that the applicant has undergone penectomy, or hysterectomy and mastectomy. 198 new york city requires that the applicant has undergone either vaginoplas­ ty or phalloplasty.199 the different standard allow, for example, a transgender individual that has undergone a hysterectomy to be recognized as their identifiable gender in one place but not another.200 unfortunately, the transgender individual has no control over what standards are applied in 193. nuskey v. hochberg. 657 f.supp.2d 47, 58 (d.d.c. 2009); glenn v. brumby, 724 f.supp.2d 1284, 1298 (n.d. ga. 2010); glenn v. brumby, 632 f.supp2d 1308, 1315 (n.d. ga. 2009); comm'n on human rights & opportunities v. city of hartford, no. cv094019485s, 2010 wl 4612700, at *9 (conn. super. ct oct. 27, 2010). 194. dean spade, documenting gender, 59 hastings l.j. 731, 765 (2008). 195. /d. at 768. 196. /d. 197. id at 769. 198. /d 199. /d. 200. /d. 2012] providing care for transgender patients 93 his jurisdiction. 201 the applicable standard depends on where the transgender individual was born and, more notably, where their birth certif­ icate was issued.202 states have denied birth certificates amendments based on the states' interests. in in re marriage license for nash, the court claimed that its de­ nial to recognize nash's amended birth certificate and the subsequent void­ ing of his marriage were in accord with ohio's public policy to deny same­ sex marriage.203 additionally, the court claimed that the approval of the marriage in nash would "start us down the slippery slope to judicially legis­ lating same-sex marriages, an area within the purview of the legislature alone.'.204 the court used the legislature's intent to hold that birth certifi­ cates could only be changed in the event of an error or mistake on the origi­ nal birth certificate. 205 in 2011, a class action filed against new york €ity alleged that the "city discriminat[ ed] against transgender people by requir­ ing more of them than .it does of others who wish to correct birth certifi­ cates.''206 a plaintiff in the suit stated that his female birth certificate has caused "humiliating confusion when he applied for health insurance at a new job.''207 in review, it is in the best interest of a health care provider to check with the local laws governing amended birth certificates. if a local statute allows for the modification of birth certificates, the health care provider should focus on the specific requirements to amend, such as surgical re­ quirements. for a summary of states' current policies on modification of gender on birth certificates, refer to exhibit b. 2. amendment of medical records the evolution of a transgender patient's transition or gender identifi­ cation is difficult for a health care organization to record in their medical records, whether electronic or physical. the health care organization has to weigh several important considerations, such as what requirements should be put in place to allow for a change in the medical record and what the re­ percussions of altering the medical record should be. additionally, the healthcare organization must decide whether it would be altering the sex, gender, or both in the transgender patient"s medical record. a health care 201. /d. 202. id at 769-70. 203. in remarriage license for nash, no. 2002-t-0149, 2003 wl 23097095, at *5 (ohio ct app. dec. 31, 2003). 204. id at6. 205. /d. 206. jennifer peltz, transgender people sue to have birth records changed, msnbc.com (mar. 22, 2011), http://www.msnbc.msn.com/id/42220931/nslhealth-health_ care/t/transgender-people-sue-have-birth-records-changedl. 207. /d. 94 indiana heal til law revmw [vol. 9:1 organization's policy for altering a transgender patient's medical record could require the patient's sex to be changed only after a patient's under­ goes certain medical treatment such as sexual reassignment surgery or until the patient has proof on an amended birth certificate. if a health care organization allows for only the sex of a transgender patient to be altered in the medical records this may risk raising red flags to the transgender patient's insurance company of the patient's gender transi­ tion and possibly denial of any future procedures. additionally, the swift change of the patient's sex in the medical record and omission of relevant information regarding the patient's transgender or intersex condition may cause a physician or other healthcare professional to improperly diagnose the transgender patient by not considering their past medical history. fur­ thermore, if a transgender patient is in transition to their identified gender, another health care professional such as a intake coordinator or nurse, may unintentionally offend the transgender patient without knowledge of the transgender patient's transition. if a health care organization allows for only the gender of a transgender patient to be altered in the medical records to reflect the self­ identified gender of the patient, it may allow for too much subjectivity to the medical records. to compensate for the large number of possible iden­ tifications by a transgender patient, the organization can allow for the fol­ lowing categories that have been suggested for transgender friendly patient intake forms: male, female, transgender, transwoman, transmale, mtf, ftm, and transqueer.208 while this type of patient identification is more sensitive to transgender patients, it may be aligned with the legal identifica­ tion of the patient's gender. a healthcare organization needs to keep on file the legal identification of a patient's gender to reconcile any legal docu­ ments,received or submitted involving the patient. currently, the veterans' health administration has taken the position of amending birth certificate to reflect the patient's self-identified gender. 209 to change the patient's name and gender in his/her medical records, the va asks for trans gender patients to submit doctimentation per the vha policies. 210 in indiana, there is no statutory or case law specifically addressing the requirements for a health care provider to alter the gender or sex in a patient's medical rec­ ord 208. patient intake, crn. of excellence for transgender healtii. http://transhealth.ucsf.edu/trans?page=protocol-intake (last visited jan. 19, 2012). 209. veterans health administration transgender healihcare directive, nat'l ctr. for tlansgender equality 4 (june 2011), http://transequality.org/pdfs/vha_trans_ health. pdf. 210. /d. 2012] providing care for transgender patients 95 3. health care consent and advance directives "in general, transgender people should remember that the issuance of a marriage license is not a guarantee that the validity of their marriage will never be challenged in the future."211 as in many states, including indiana, if an individual is unable or incapable to consent to a health care decision and has not appointed a health care representative, the spouse of the may give consent on behalf of the individual. 212 however, if a court finds that a transgender individual is the same-sex as his or her partner, making their marriage void, the transgender individual would not be able to consent for their partner unless otherwise directive by advance directive or other in­ strument. this would give the transgender individual the same options as same-sex couples when trying to give this partner rights to medical deci­ sions. all transgender and lgbt individuals should strongly consider exe­ cuting an advance directive, which give an individual the ability to name his or her partner as health care proxy, insuring that "his or her partner will not be excluded from health care information and decision-making in the event of routine or emergency medical examinations and procedures."213 alt­ hough requirements for advance directives are generally defined by state laws, there is one federal law addressing the advance directives.214 in 1990, congress passed the patients self-determination act, requiring that health care providers receiving medicaid and medicare to provide information to patients concerning their individual rights to make medical decisions under state law and the right to create an advance directive.215 "while some state laws provide for an advance directive that allows one and to express preferences concerning life-sustaining treatment, name an agent to make health care decisions or do both, some states have separate statutes for living wills and durable power of attorney for health care."216 depending on the device executed, same-sex couples, including transgender couples, are given the option to appoint their partner as a surrogate of medi­ cal decisions at all times, including when the patient is incapacitated or un­ able to communicate.217 depending on the jurisdiction, individuals can execute a combination of these legal devices.218 additionally, it is important to note that a conscious clause is available 211. nothing but the truth: busting common myths about transgenderrights, lamda legal (dec. 14, 2007), http://www.lambdalegal.org/publications/nothing-but-the-truth. 212. ind. code§ 16-36-1-5 (2011). 213. shawna s. baker, where conscience meets desire: refusal of health care pro­ viders to honor health care proxies for sexual minorities, 31 women's rts. l. rep. 1 (2009). 214. 102 am. jur. 3d proof of facts § 95 (2008). 215. baker, supra note 213, at 2. 216. 102 am. jur. 3d proof of facts § 95 (2008). 217. baker, supra note 213, at 20. 218. /d. 96 indiana realm law review [vol. 9:1 to health care providers to exercise.219 conscious clauses provide healthcare providers with ''the right to refuse to participate in certain medi­ cal procedures, treatments or services.'.220 a majority of states' conscious clause legislation is narrowly focused on abortion.221 vi. recommendations for futijre transgender legal issues the beginning of this article began by articulating the defmition of pa­ tients' rights and how these rights are not guaranteed for trans gender pa­ tients. while most organizations do provide for a patient bill of rights that may or may not include transgender patients, this is not legally binding or a way to state a claim for a transgender patient. additionally, the consumer bill of rights and responsibilities tfom the 1998 the president's advisory commission on consumer protection and quality in the health care in­ cluded an anti-discrimination that included based on sex or sexual orienta­ tion. the remedy listed under the consumer bill of rights and responsibilities contains only information for the consumer complaint pro­ cess. furthermore, the consumer bill of rights and responsibilities lists public and private health plans procedures for responding to consumer complaints. rec~ntly, the patients' rights listed in the affordable care act does not contain an anti-discrimination clause but relates generally to insurance fraud and coverage despite pre-existing conditions?22 to give transgender federal protection from discrimination, the affordable care act would need to be amended to prohibit discrimination based, on: race, ethnicity, national origin, religion, sex, gender identity, age, mental or physical disability, sex­ ual orientation, genetic information, or source ofpayment.223 until a feder­ al anti-discrimination clause is added to the affordable care act, it is up to health care organization to include and enforce similar ant-discriminatory policies within their organization. 1bis emphasis should be on the en­ forcement of the policy and penalties for violation of the policy. further­ more,· it is essential that all patients, including transgender patients, feel comfortable filing ·complaints of discriminatory treatment with the health care organization. as with any areas of law, the wearisome factor oftransgender legal is­ sues comes from the lack of consistency by courts in interpreting the laws, such as title vii. furthermore, court opinions lack uniformity involving amendment of birth certificates and transgender right to marry. the majori219. /d. at 14. 220. /d. 221. /d. at 15. 222. patient's bill of rights, healmcarb.oov, http://www.healthcare.gov/law /features/rights/bill-of-rights/index.html (last visited jan. 16, 2012). 223. am. cancer soc'y, supra note 55. 2012] providing care for transgender patients 97 ty of court decisions involving transgender individuals involve interpreting the terms sex and gender and applying these terms to the appropriate stat­ ute. several courts follow the precedent set by corbett v. corbett, which improperly interpreted sex and gender to be biologically determined at birth and not subject to modification. modern courts of today should realize that the corbett decision was made in 1970, before the development of modern medical technology; courts did not have any reason to understand and re­ search the legal aspects of gender and sex modifications. instead of following an outdated decision such as corbett, modern courts should look to decisions like in re heilig, in which the court was thorough in its research of medical definitions, treatises, and opinions on gender and sex. from this research, the heilig. court was able to properly define sex and gender in accordance with current medical definitions, which states that gender relates to a person's psychosexual individuality or identi­ ty, while sex refers to a person's anatomical or biological sex.z24 if future courts take the lead of the heilig court, and align their interpretations of these terms with the common medically accepted definition, the legal com­ munity will find the laws more reliable and be able to better represent their transgender clients. legal professionals will be able to bring cases under title vii employment discrimination with a concrete definition of gender to be used in gender discrimination claims involving transgender plaintiffs. furthermore, if the courts begin to consistently define these terms to be in conjunction with the medical definitions, this allows for non-legal professionals, such as medical professionals, transgender patients, employ­ ers, and layman, to better understand the current interpretations of laws re­ lated to transgender. for example, with more consistency, a nurse or physician would be more knowledgeable in assisting transgender patients on their legal rights and remedies for discrimination, consent of a partner, claims against insurance denial, etc. currently, it is a challenge for legal professionals to understand the legal rights and remedies of a transgender patient. it would be an unreasonable task to ask our healthcare profession­ als interpret the conflicting current court opinions concerning transgender patients and to keep up-to-date with any future court opinions. for this rea­ son, the following recommendations are given to make healthcare providers knowledgeable on how to ensure that its medical environment and its healthcare professionals' actions are sensitive to the needs of trans gender patients. vii. recommendations for health care providers "all citizens deserve the right to proper medical treatment regardless 224. in re heilig, 816 a.2d 68, 69 n.4 (md. 2003). 98 indiana health law review [vol. 9:1 of their gender identity.''225 as demonstrated, current federal and state laws have gaps that do not protect transgender patients from discrimination by giving transgender pa­ tients a claim of action. a significant gap relevant to federal statutes, such as title vii, and state statutes, such as birth certificate amendments, and in turn marriage rights, is the interpretation of the terms "sex" and "gender." the discrepancy occurs when courts interpret "sex" and "gender" as synon­ ymous terms that cannot be altered from the sex determined biologically at birth. alternatively, medicine defines "sex" and "gender" as different terms, in which an individual's sex can be altered. until the legal and med­ ical interpretations of these terms are aligned, it is up to the health care community and individual health care organizations to protect transgender patients from discriminatory treatment, and honor their rights as a patient. all healthcare facilities should be adequately prepared to provide competent and compassionate care for transgender patients by becoming familiar with recent research and striving to understand the lived experience of the transgender patient.226 unfortunately, because of uncomfortable en­ counters, many transgender patients avoid health care facilities, leaving them to look for their medical care needs, such as hormones, on black mar­ kets.227 silicone injections are another extremely dangerous procedure un­ dergone by transgender individuals, which are often performed without the assistance of a health care professional.228 silicone injections are used for body modifications such as creating the image of shapely hips or changing other various body parts. 229 "these tragic events occur because people find other ways to get the care that they need because they feel that they can no longer get care in the mainstream healthcare system .• mo a study performed in 2005 by the transgender training project of the new england aids education and training center found that providers had: 1) a desire to treat trans gender patients respectfully but admitted dis­ comfort and lack of tools for specific interviewing/assessments, 2) experi­ ence with transgender patients but lacked information on distinctions among transgender experiences, 3) time constraints that created barriers to developing trusting relationships with their transgender patients, 4) frustra­ tions with the lack of information, research, and guidelines to treat transgender patients, and 5) beliefs that transgender people themselves are an essential teaching resource.231 according to the university of michigan 225. decleene, supra note 67, at 138. 226. sue thomas, competent care of the transgendered patient: nurse as advocates, unjv. of vt. dep't of nursing 2 (2004), http://www.transgendered-soul.comffransition pdf/competentcareoftg4.pdf. 227. silverman, supra note 62. at 350. 228. ld. 229. jd. 230. ld. 231. lurie. supra note 4, at 93-94. 2012] providing care for transgender patients 99 medical school, better care for lgbt patients can be achieved through four simple changes: 1) updating the physical environment of the facility; 2) adding or changing intake and health history form questions; 3) improving provider-patient interviews, and 4) increasing the staff's knowledge about and sensitivity to lgbt patients.232 a. adapt your intake forms and intake process regardless of the training or level of sensitivity of the provider, if the personnel at the front desk unintentionally offend a transgender patient, this can have destructive affects for both the future health of the transgender patient and the reputation of the healthcare provider.233 a common exam­ ple occurs either by the actions of an intake employee towards a transgender patient or when the transgender patient is filling out intake forms during the intake process. several problems can occur here; for example, transgender individuals may have identification such as a driver's license or birth certif­ icate that represents their legal gender, their legal birth name, and their gen­ der presentation prior to their period of gender transition, thus leading to the wrong gender identification in the clinical record. 234 the commonly used intake forms can cause a transgender patient to feel discouraged and mistrust the health care system. first, forms typically ask for sex based on the binary schema by providing two boxes, male and female. a transgender patient may not identify with either male or female, or may feel uncomfortable identifying with either gender. refer to exhibit c for an example of a commonly used intake forms that have been revised to be inclusive of transgender patients. the proposed changes to intake forms include offering the following four options for relationship status: single, married, partnered, and other.235 additionally, the waiting room at­ mosphere can create an unwelcoming or unaccepting atmosphere that may cause a transgender patient to have doubts about the healthcare facility, giv­ ing him or her less incentive to be honest with their treating medical staff. proposed updates to the waiting room include offering at least one unisex restroom, a visible non-discrimination statement, and lgbt specific media including national or local magazines, posters showing racially and ethni­ cally diverse same-sex couples, and brochures about lgbt health con­ cerns.236 as discussed earlier, health care organizations have several competing considerations when determining whether to alter medical records of 232. caring for lesbian, gay, bisexual, and transgender patients, a university of michigan resource guide, univ. of mien. med. sch. 10 (2005). 233. lurie, supra note 4, at 104. 234. silverman, supra note 62, at 348. 235. univ. of mich. med. sch., supra note 232, at 12. 236. !d. at 11. 100 indiana heal til law review [vol. 9:1 transgender patients, electronic or physical. to combat these concerns, health care organizations can allow for the gender of a patient to be changed based on the self-identification of that patient. since statutory guidance is not present for health care organizations on when to alter the sex of a pa­ tient on a medical record, it is would be in best practice for a health care organizations to develop its own policies or keep the biologically born sex of the patient also available on the medical record. for example, if a transgender patient was biologically born female and is currently transition­ ing to a male, but identifies himself as a female to male transgender; it would be reflected in his medical record by having his sex as female and his gender as ftm. this approach allows for the sensitivity of gender identifi­ cation to transgender patients, while keeping the organization legal in com­ pliance. additionally, this notification to a physician, nurse, or other health care professional, such as an intake coordinator, that can assist in treatment, diagnosis, and sensitivity during social interactions. b. a healthcare provider's actions and words health care providers have the responsibility to present their medical care ·· in the best interest of their patients. if a provider is aware that transgender patients often have misgivings about providers, then the pro­ vider is responsible for educating herself on strategies that can help over­ come these doubts. now it is important to note that if a provider lacks the proper training on how to overcome these obstacles with transgender pa­ tients, that does not mean the provider is lacking in ability. regrettably, "[t]ranssexual care is currently seldom taught in medical school, and medi­ cal and endocrinology textbooks are often outdated and misinform read­ ers. "237 thus, it is up to the provider to seek additional resources and knowledge on how to effectively treat transgender patients. transgender individuals often cite providers' actions and choice of words as reasons not to trust them. 1. · use of proper pronouns the biggest mistake by any health care provider or any service pro­ vider is the improper use of pronouns when referring to a transgender indi­ vidual. the proper reference to a transgender individual is to use the pronoun associated with the identified gender of that particular individu­ al. 238 providers should be aware that not all people within the trans gender community identify with the term, "transgender," or are aware of its mean237. decleene, supra note 67, at 138 (citing r. nick gorton et. al., medical therapy & health maintenance for transgender men: a guide for health care providers 9 (2005), available at http://nickgorton.org). 238. lurie, supra note 4, at 97. 2012] providing care for transgender patients 101 in g. 239 providers may be surprised by the increased comfort in trans gender patients when the providers follow just this one important guideline. 2. a provider's approach before conducting an interview while referring to a transgender patient with the proper pronoun is important, it is not the only respect to keep in mind when treating a transgender patient. all providers, like all people, have emotions or thoughts they cannot control. as a health care provider, it is important to not pre-judge a trans gender patient. a provider may have. pre-conceived notions on what he/she believes transgender people do or do not do in their everyday lives. nonetheless, it is extremely important for a medical profes­ sional to approach a transgender patient without any prejudice concerning the choices and lifestyle of that patient. the provider should approach the transgender patient as an individual, while keeping in mind common health care risks association with the transgender population. for example, many physicians tend to over focus on the sexual history of transgender patients. while this is an important health risk for some transgender people, it is not a health risk for all transgender people. this concept is in agreement with a health care provider's respect for patient's autonomy and self determina­ tion. 3. the interview process unintentional discrimination towards a transgender patient by a pro­ vider can occur during the interviewing process. as previously discussed, unless the treating physician feels the sexual history of that particular transgender patient is significant, the provider should avoid dwelling on the sexual history of that transgender patient. transgender patients are often stigmatized as having a promiscuous sexual history. stereotyping a transgender patient by assuming he or she has a complicated sexual history can be another factor that causes the patient to distrust the health care com­ munity. "understanding that there is a power relationship, but also wanting to build rapport, asking questions in an afftrming way and not assuming to know what a patient wants or needs were also seen as essential to effective interviewing. "240 the best way for a provider to avoid stigmatizing a transgender pa­ tient is for the provider to conduct the interview by asking open-ended questions. "providers need to ask open-ended questions that are general in scope" so that "patients can answer as is appropriate to them."241 providers 239. id. at 99. 240. !d. 241. id. 102 indiana health law revmw [vol. 9:1 should use the same language as patients in describing themselves but avoid using any derogatory terms the patient may use to describe themselves. 242 c. be knowledgeable on the health needs oftransgender patients health care professionals have a duty to be better informed about the health needs of the transgender community, just as they have the duty to be informed about any patient. as previously discussed, it is important for a provider to treat a transgender patient as he/she would treat a non­ transgender patient, by asking questions about the patient's family history of high blood pressure, cholesterol, cancer, etc. yet, the provider needs to also keep in mind that equal treatment, or focusing only on the transgender patient's health concern that do not relate to being transgender, can worsen the environment for transgender patients. as a transgender individual, transgender patients have specific need related to being transgender that should not be ignored. unfortunately, transgender patients have had more discriminatory life experiences than most patients. the discrimination that these individuals face in everyday social settings, such as the workplace, is due to their transgender status, which makes their mental health issues de­ serving of special attention.243 "although the neutral posture espoused by providers is intended to 'depathologize' lgbt people, it may divert atten­ tion from the issues of discrimination, stigmatization, and violence, which affect the mental health of sexual and gender minorities in rural settings."244 some of the common health risks cited for trans gender individuals are increased risk of substance abuse, suicide, depression, and other mental health disorders. again, as a provider, these health risks should always be considered when treating a transgender patient but should never be the de­ ciding factor in a diagnosis. providers should be cautious when speaking about these health risks and always remember that for a transgender patient there is a stigmatization attached to many of these health risks. as previ­ ously discussed, transgender patients often lack an adequate support team. providers should keep in mind a transgender patient's current support team when recommending or administering any care. there are numerous medical concerns for providers to keep in mind when treating transgender patients. once again, these suggestions are not true for all transgender patients and a provider should base their medical opinion on the individual transgender patient. the research concerning long-term hormone usage is continually evolving and should be referred to frequently by providers. additionally, a provider should be aware of the interactions of hormones with any other medications used by the 242. unn. of mich. med. sch., supra note 232, at 12. 243. cathleen e. willging et a/., unequal treatment: mental health care for sexual and gender minority groups in a rural state, 57 psychiatric servs. 867, 870 (2006). 244. id. 2012] providing care for transgender patients 103 transgender patients. transgender patients commonly undergo cosmetic procedures as part of their transition. many of these cosmetic procedures have side effects and associated risks procedures. providers should note any past cosmetic procedures undergone by transgender patients when ad­ ministering care. furthermore, providers should always give transgender patients all information regarding a procedure prior to getting consent from the transgender patient to perform the procedure. it is important for health care professionals to understand that not all transgender patients feel the need to have sexual reassignment surgery. for some transgender people, taking on their identified gender with the aid of hormones is satisfactory. d. be knowledgeable about non-medical concerns oftransgender pa­ tients to provide a holistic approach to health care, a provider has a duty to understand the personal experiences of his/her patients and the daily strug­ gles they may face. "whether a ·hospitalization is related to a sex reassign­ ment surgery or a broken bone, a professional level of knowledge combined with sensitive and empathetic care can help reduce needless stress and facil­ itate the healing process. "245 several of the larger problems transgender people are forced to confront have been addressed earlier in this article (e.g., marriage rights, amendment of birth certificates, and recognition of identified gender by the law and society~ and employment discrimination). while these problems are worth recognizing, it is important to keep in mind the daily struggles of a transgender person. from a clinical perspective, a large. struggle for some transgender pa­ tients is the absence of support by family, friends, and co-workers in transi­ tion to their recognized gender. for some, they may have lost members of their support team when they have expressed to the family member or friend that they were transgender. it cannot be doubted that the gender tran­ sition process is mentally, physically, and financially exhausting. it is im­ portant for a healthcare provider to identify members of a transgender patient's personal support team or the lack of a support team for the patient or possibly assist in creating a support team. financial struggles are also a common obstacle for transgender indi­ viduals. a serious strain on the fmancial stability of a transgender · individ­ ual can involve the loss of income from termination of employment. as previously discussed in the cases involving employment issues, transgender individuals are often wrongfully terminated after starting the transition pro­ cess or after undergoing a sexual reassignment surgery. while it is possible for a transgender employee to recover under title vii in some jurisdictions, the costs of legal fees and the loss of income before judgment are often un245. thomas. supra note 226, at 2. 104 indiana health law review [vol.9:1 bearable for most. additionally, the cost of sexual reassignment surgery can create financial obstacles for many transgender patients. the average cost in 2001 for a male-to-female surgery was about $10,400. for a female­ to-male, primary surgery (top surgery) was approximately $8,500; and for a female-to-male, bottom surgery was approximately $9,500.246 because most insurance policies do not cover such procedures, these excessive costs must be paid through out-of-pocket expenses. e. attend trainings/seminars dedicated to the needs oftransgender pa­ tients this article is aimed at informing healthcare providers about transgender patients but in no way should this be the end of a provider's education on transgender patients. instead, this article should provide an overall picture to providers on the current healthcare environment for treat­ ing transgender patients. change must be system wide for a culturally in­ clusive environment to be created.247 "efforts must be made to reform treatment systems by empowering providers through ongoing training and the enforcement of institutional and public policies prohibiting lgbt dis­ crimination. "248 furthermore, for a culturally inclusive environment to be created for transgender patients, the patients should not be asked questions to educate the health care providers for educational purposes. "many transgender people have enough self work to do and enough self stuff going on that the last thing they want to do is train someone on their needs or the needs of the transgender community, so it becomes the provider's responsibility to have that information."249 providers should not feel it is the duty of the transgender patient to educate the provider on their needs.250 instead, it is the duty of the healthcare facility to educate its employees on the needs of trans gender patients by routinely allowing for training in transgender health needs.251 the initiation of a culturally inclusive environment for lgbt patients starts with the revision of current companywide policies and the creation of some new improved policies involving the treatment of diverse patients. in a study conducted by the transgender training project of new england aids education and training center, it was found that providers felt there were five specific issues that were institutionally based: 1) agencies have 246. mary apn horton, the cost of transgender health benefits, transgender at work, sept. 2008, available at http://www.tgender.net/taw/thb!i1fbcost-oe2008.pdf. 247. lurie, supra note 4, at 104. 248. willging et al., supra note 243, at 870. 249. lurie, supra note 4, at 99. 250. decleene, supra note 67, at 138. 251. id 2012] providing care for transgender patients 105 the responsibility to be inclusive and to have policies in place for culturally competent treatment of transgender people; 2) making an agency welcom­ ing should not be up to any one individual; 3) individuals who want change within their agencies may not be empowered to create that change; 4) there is a transphobia and resistance among staff; and 5) training and awareness must be across all levels of stati: including front desk staff.252 company­ wide policies are typically the most time consuming policy changes but can have the largest impact on the reputation of the provider and the treatment of patients. an easier adjustment for a healthcare facility, which should ideally be implemented with the companywide policies, is to establish an educational training program for all employees to attend that focuses on the needs of transgender patients. the following training suggestions have been identi­ fied as training needs for providers: 1) staff at all levels should attend awareness training; 2) transgender people should be trainers; 3) appropriate languages to use in interviews should be provided, including role plays of specific interviewing skills; 4) issues may be better incorporated into broader training on diversity or other topics to overcome the potential issue of attendance by providers; 5) utilize training methods that are already in use such as journals, web pages, in-services, or conferences; and 6) incorpo­ rate training in curriculum for medical students if the providers is associated with an medical school.253 healthcare providers should utilize the transgender trainers by asking any questions they feel would help them identify or better understand their transgender patients. transgender train­ ers can give a face and a voice to the issues transgender people. face in eve­ ryday society and while at a healthcare facility. the interactions with the trainers, and not the transgender patients, should be the educational resource tool made available to healthcare providers for any concerns or issues they may currently be having with their transgender patients~ the training pro­ vided by the healthcare facility does not need to be solely focused on the needs of transgender patients. instead, the available training can be includ­ ed in other culturally competent training concerning the needs of minority patients. f. gain experience working with transgender patients in addition to trainings, all healthcare providers should increase their experience treating transgender patients. ''the lack of experience influ­ ences a sense of discomfort on the part of the providers, and this can then lead to unhelpful or even hostile treatment of the trans client. ,.254 ''this can 252. lurie, supra note 4, at 104. 253. /d. 254. id at 97. 106 indiana health law review [vol. 9:1 be based on lack of knowledge and discomfort.''255 experience working more with transgender patients can relieve any discomfort a healthcare pro­ vider may have when treating a transgender patient. like any skill, experi­ ence is needed to become adept at providing care for transgender patients. with additional experience, providers will develop new questions concern­ ing transgender patients that can be addressed with the transgender trainers, creating a continuing educational environment for the providers. a program designed to educate physicians, nurses, employees, and other healthcare providers through literature, videos and other mediums is not the end of the recommended training that should be made available to health care professionals regarding transgender patients. the mediums pro­ vided in these trainings inform providers about the physical, psychological, emotional, and legal struggles oftransgender patients. however, being ed­ ucated on these struggles enables providers to take the next step in giving comprehensive care to transgender patients, which is the ability to begin giving effective treatment for transgender patients in real-life situations. this next step is stated as only "starting" to treat transgender patients be­ cause like any new situation, it will take time for the health professional to develop the required skills for appropriately treating transgender patient. viii. conclusion the needs of transgender patients are unmet in the healthcare envi­ ronment. the medical struggles faced by transgender individuals are virtu­ ally ignored by the healthcare community, and typically only discussed when speaking about hormone therapy and sexual reassignment surgeries. the life of a transgender patient is not like the life of other patients. transgender patients face daily discrimination and alienation from society and even friends and family. by understanding the many legal, medical, emotional, and societal struggles that transgender patients face, a healthcare provider can empathize and better diagnose these patients. a healthcare provider has the duty to be educated on these possible struggles by attend­ ing training that gives guidance on providing culturally comprehensive treatment to trans gender patients. furthermore, it is the responsibility of a healthcare facility to better educate its support staff and health care profes­ sionals by offering training programs with transgender instructors. the available training could be easily implemented into other culturally compe­ tent trainings that are offered regularly and can yield large results in terms of welcoming transgender patients. it is the responsibility of the healthcare community to bridge the gaps left by the law and protect transgender pa­ tients from discrimination. to accomplish this, health care professionals need to be knowledgeable about transgender patients and their needs. fur255. id 2012] providing care for transgender patients 107 thermore, transgender patients require rights under most patient bill or rights. it is up to the health care community to be accountable and honor these trans gender patients and their rights. 108 indiana health law review [vol. 9:1 exhibit a: 9 recommended principles for correctional health professionals to follow in providing for the needs of transgender prisoners the management of medical (e.g., medically necessary hormone treatment) and surgical (e.g., genital reconstruction) transgender issues should follow accepted standards1 developed by professionals with exper­ tise in transgender health. determination of treatment necessary for transgender patients should be on a case-by-case basis. ideally, correctional health staff should be trained in transgender health care issues. alternative­ ly, they should have access to other professionals with expertise in transgender health care to help determine appropriate management and pro­ vide training in transgenderissues. because inmate-patients may be under different stages of care prior to incarceration, there should be no blanket administrative or other policies that restrict specific medical treatments for transgender people. policies that make treatments available only to those who received them prior to incar­ ceration or that limit gid treatment to psychotherapy should be avoided. policies that attempt to "freeze" gender transition at the stage reached prior to incarceration are inappropriate and out of step with medical standards, and should be avoided. diagnosed transgender patients who received hormone therapy prior to incarceration should have that therapy continued without interruption pending evaluation by a specialist, absent urgent medical reasons to the contrary. transgender inmates who have not received hormone therapy pri­ or to incarceration should be evaluated by a health care provider qualified in the area of trans gender health to determine their treatment needs. when de­ termined to be medically necessary for a particular inmate, hormone thera­ py should be initiated and sex reassigmrient surgery considered on a case­ by-case basis. regular laboratory monitoring should be conducted accord­ ing to community medical stim.dards. treatment for genital self-harm or for complications arising from prior surgery or from self-treatment should be provided when medically neces­ sary. correctional health care providers should provide patient education materials to help transgender patients cope with their diagnosis and treat­ ment. psychotherapy such as "reparative" therapy or attempts to alter gender identity should not be employed. reparative therapy inappropriately por­ trays gid as a mental illness and not a medical condition. 2012] providing care for transgender patients 109 in matters of housing, recreation, and work assignments, custody staff should be aware that transgender people are common targets for violence. accordingly, appropriate safety measures should be taken regardless of whether the person is placed in male or female housing areas. transgender inmates receiving hormone therapy should receive a suf­ ficient supply upon release to last until a community provider assumes care. referrals should be made to community-based organizations with sensitive and inclusive services for transgender people. correctional policies for management of transgender inmates should be developed and implemented in partnership with local transgender com­ munities, particularly current and former inmates, and transgender service providers when possible. exhibit b: list of state statutes regarding amending birth certificates. state amend birth certificates court order proof required statute 110 indiana health law review [vol. 9:1 2012] providing care for 'transgender patients 111 exhibit c: example of intake questionnaire 1. what is your current gender identity? (cheek and/or eirele all that apply)256 omale 0 female 0 transgender femalelfranswoman!mtf 0 genderqueer 0 additional category (please 0 decline to answer 2. what sex were you assigned at birth? (cheek one)257 omale 256. ctr. of excellence for transgender health, supra note 208. 257. id specify): 112 indiana health law review [vol. 9:1 0 female 0 decline to answer 3. what is your current relationship status? (check all that apply)2ss 0 single 0 married 0 partnered 0 other what pronouns do you prefer? __________ 259 exhibit d: lgbt youth rankings of healthcare provider qualities rank 1: is competent (i.e. has good medical skills) is respectful to me is honest with me listens to me -treats gay, lesbian, bisexual and transgender youth the same as other youth makes me feel comfortable is nonjudgmental rank2: is willing to refer me to another provider if they are not able to take care of all my health needs is educated about hiv transmission and prevention is supportive of my total well being is friendly and personable helps me to make decisions about my health care explains everything to me in ~~plain language" knows when to consult with colleagues to get other information/opinions rank3: is educated about gay and lesbian health issues is experienced working with youth is intellectually inquisitive does not rush during the visit rank4: has a good sense of humor has been working in the health field for a long time -is experienced working gay, lesbian, bisexual 258. unn. of mich. med. sch., supra note 232, at 12. 259. ctr. of excellence for 'transgender health, supra note 208. 2012] providing care for transgender patients 113 youth asks me about my ideas for what is wrong· with my health ranks: -uses gay-inclusive language during the interview and on forms i am asked to fill out at the visit rank6: is educated about transgender health issues rank7: is the same gender as me is experienced working with transgender youth rank 8: has the same sexual orientation as i dolt>u exhibit e: lgbt youth rankings of office or health center quali­ ties rank 1: is clean accepts my health insurance ' rank2: has friendly staff offers screening and treatment for sexually transmitted diseases allows me to come without my parent/guardian offers hiv testing provides confidential care for minors ( <18 years old) rank3: has information about referrals to mental health providers experienced with lgbt youth has information about referrals to community agencies for lgbt youth allows the same provider to see me visit to visit makes sure the provider sees me on-time has an easy process for getting appointments has a short waiting time to get appointments offers mental health services 260. neal d. hoffman. m.d., katherine freeman, dr.ph,. & stephanie swann, ph.d., healthcare preferences of lesbian, gay, bisexual, transgender and questioning youth, 45 j. adolescent health 222-229 (2009). 114 indiana healtii law review [vol. 9:1 rank4: offers support groups for youth offer gynecological care has evening hours available is located near to where i live has weekend hours available asks for input from youth about programs/services has sliding fee scale for youth without insurance rank5: displays magazine, health education posterslbrochures/videos for youth displays magazine, health education posters/brochures/videos for lgbt youth rank6: has an e-mail address for correspondence advertises itself as ''trans gender friendly'' rank7: plays good music in the waiting area has a waiting area for youth ranks: -provides care to youth onl~01 exhibit f: lgbt youth rankings ofhealth concerns or problems to dis­ cuss with a health care provider rank 1: 261. !d. at 5. depression medication side effects stds hn/aids -preventative health care (staying healthy) std treatment and transmission issues for partners suicidal feelings taking multiple medications (e.g. chronic illnesses) -nutrition -safe sex family problems risky or unsafe sexual behavior 2012] providing care for transgender patients 115 rank2: holistic and complementary treatments harassment or violence in the community harassment or violence at school or work druguse alcohol abuse all sexual behavior partner/domestic violence other gynecologic problems sexual relationships menstrual problems future goals in personal life -job safety (work-related injuries) -smoking sexual orientation having children/parenting options other male sexual health concerns testicular problems pregnancy prevention body piercing talking to parents/family about being lgbt -tattooing rank3: sexual pleasure taking feminizing or masculinizing hormones being transgender masturbation talking to :rarents/family about being transgende?62 262. id at6. from [a]nthrax to [z]ika: key lessons in public health legal preparedness james g. hodge, jr., jd, llm* lexi c. white, jd** sarah a. wetter, jd*** i. introduction over fifteen years ago, the 2001 terrorist and anthrax attacks in the united states led to seminal law and policy changes in public health planning, preparedness, and response. coextensively, a litany of major public health1 threats and challenges (e.g., west nile virus, hurricane katrina, h1n1, ebola, measles, zika) have emerged. each of these events required real-time responses and solutions among federal, tribal, state, and local actors, as well as private sector partners. these responses pursuant to “legal triage” include significant2 reforms in public health emergency (phe) laws and policies during and after the exigencies. emergency preparedness is a primary focus across all levels of government and throughout health care and other industries. hundreds of billions of dollars have been spent to prepare for and prevent public health events that are unpredictable in their timing, physical and mental health impacts, and costs. hundreds of thousands of public health officials, health care workers (hcws), emergency managers, and others have been educated and trained in preparedness and response efforts. the science of preparedness has revealed innovative approaches to abating negative public health repercussions while minimizing intrusions on individual rights. americans are more knowledgeable and aware of public health risks, though some public health preparedness messages have had limited utility (e.g., colored terrorism level alerts from the department of homeland security (dhs)).3 the field of emergency public health preparedness has been reformed * professor of public health law and ethics; director, center for public health law and policy (cphlp); director, network for public health law – western region office, sandra day o’connor college of law, arizona state university (asu). this article is based in part on my lecture of the same title for the symposium, ideology meets reality: what works and what doesn’t work in health policy, on october 21, 2016, at indiana university robert h. mckinney school of law, indianapolis, indiana. ** fellow, cphlp; consultant, network for public health law – western region office, sandra day o’connor college of law, asu. *** research scholar, cphlp, staff attorney, network for public health law – western region office, sandra day o’connor college of law, asu. 1. james g. hodge, jr., the evolution of law in biopreparedness, 10 biosecurity & bioterrorism 38, 39 (2012). 2. james g. hodge, jr. & evan d. anderson, principles and practice of legal triage during public health emergencies, 64 n.y.u. ann. surv. am. l. 249, 252 (2008). 3. john schwartz, u.s. to drop color-coded terror alerts, n.y. times, nov. 25, 2010, at a24. http://doi.org/10.18060/3911.0042 24 indiana health law review [vol. 15:23 globally and domestically in less than a decade and a half. and now, with multiple events in hindsight, long-term observations and lessons in emergency legal preparedness are coming into sharper focus. fundamental issues of national and regional legal preparedness in the united states are explored below in five premier themes. part ii examines the changing definitions and scope of phes at all levels of government. by no means bootstrapped to initial conceptions of phes immediately following 9/11, phes continue to be declared in response to multifarious events, some of which are warranted, others less so. part iii assesses the pervasive classification of phes as national security threats (nsts) under federal laws and policies. the propensity of the president and other federal actors to tag phes as threats to national security brings public health policy into new realms that may strain federal-state relations in future events. part iv looks closely at newly implemented federal social distancing powers crafted by the centers for disease control and prevention (cdc). moving past decades-old, antiquated notions of federal roles in separating ill and well populations, the cdc revolutionized and expanded its powers, but at what costs? part v dives into the liability “sinkhole” impacting participatory efforts among hcws and volunteers. the potential for emergency responders to be liable for unproven, sometimes chaotic efforts to screen, test, and treat patients has always been a major concern. longstanding debates on how to best address these concerns while assuring injured patients access to justice are finally becoming clearer. finally, part vi describes one of the most important lessons of public health legal preparedness: that its utility is not limited to one-off-ramp emergency events or short-term responses. as illustrated through multiple examples, creating and applying emergency preparedness laws and policies affect routine, day-to-day public health laws and practices. preparedness is not only good for emergencies, but also for regular public health practices. a brief conclusion follows. ii. the scope of public health emergencies for decades, the concept of phe preparedness in the united states was largely unheralded, misunderstood, or ignored by most lawmakers, government officials, hcws, and citizens. the role of law in preparing for a bioterrorism or4 mass casualty event was under-studied, and as a result, underdeveloped. only select lawand policy-makers argued for legal changes or systemic overhauls to address emerging threats, and virtually none foresaw the need for a complete restructuring of government to respond to public health emergencies. 5 4. see james g. hodge, jr., public health emergency legal and ethical preparedness, in oxford handbook of am. health l. 1008 (glenn cohen et al. eds., 2015) (explaining that apathy is hard to understand given multiple and diverse public health threats experienced nationally or regionally leading up to september 11, 2001). 5. cantigny conf., state emergency health powers & the bioterrorism threat (april 2627, 2001), http://www.heart-intl.net/heart/legal/comp/stateemergencypowers.htm [https://perma.cc/uq4w-quly]. 2018] from [a]nthrax to [z]ika 25 the terroristic acts and anthrax attacks in september 2001 changed everything. combatting terrorism in all its forms became a primary, national objective, which continues to modern day as per the expressed goals of defeating terrorist cells espoused by donald j. trump as part of his presidential campaign.6 immediately following the terrorist attacks on 9/11, the nation welcomed major changes ushered in through systemic legal reforms to: (1) rebuild legal response capabilities; (2) newly classify phes; (3) rebalance individual rights with government’s need to protect populations from national or regional public health or security threats; and (4) define emergency roles and responsibilities among public and private actors. during this time, the centers for law and the public’s health drafted and introduced the model state emergency health powers act (msehpa) in december 2001. subject to some criticisms among scholars, civil rights7 advocates, media, and the public, msehpa laid out a structured and cohesive8 menu of model provisions largely for state and local governments considering how to respond to bioterrorism or other public health crises. a primary goal of9 msehpa was to balance individual and communal interests underlying modern responses to a phe, defined as: an occurrence or imminent threat of an illness or health condition that: (1) is believed to be caused by . . . bioterrorism; the appearance of a novel or previously controlled or eradicated infectious agent or biological toxin [or other causes]; . . . and (2) poses a high probability of . . . a large number of deaths in the affected population; a large number of serious or long-term disabilities in the affected population; or widespread exposure to an infectious or toxic agent that poses a significant risk of substantial 6. full text: donald trump’s speech on fighting terrorism, politico (aug. 15, 2016, 3:15 pm), http://www.politico.com/story/2016/08/donald-trump-terrorism-speech-227025 [https://perma.cc/5chr-98aq]. 7. james g. hodge, jr. & lawrence o. gostin, protecting the public’s health in an era of bioterrorism: the model state emergency health powers act, 10 accountability in res. 91 (2003). 8. george j. annas, worst case bioethics: death, disaster, and public health (2010). 9. see u.s. dep’t of health & human servs., emergency system for advance registration of volunteer health professionals (esar-vhp) legal and regulatory issues, (2006), h t tp : / /www.publ ichea l th l aw.net /research /pdf/esar%20vhp%20repor t .pdf [https://perma.cc/4qd9-spde] (explaining that despite some concerns, multiple national public health and policy-making entities supported the premises of the act, including cdc, the american public health association (apha), association of state and territorial health officials (astho), national association of county and city health officials (naccho), national conference of state legislatures (ncsl), national governors association (nga), national association of attorneys general (naag), and american medical association (ama). perhaps the most telling support for msehpa came from legislatures and regulatory agencies across the united states and internationally). https://doi.org/10.1080/08989620300507 26 indiana health law review [vol. 15:23 future harm to a large number of people in the affected population.10 a stateor local phe declaration may be issued by the governor (with recommended input from state health authorities) only when an act of bioterrorism or other public health threat poses a “high probability” of a large number of deaths, disabilities, or exposures to agents that could cause future harms. these definitional limits were intended to confine phe declarations to circumstances where rapid factors militated an efficient and effective public health response that may necessitate differing standards relating to respect for individual rights. soon after national implementation of legal reforms based on msepha, however, the concept and role of phes began to change. as per11 table 1, below, phe declarations arose in response to a variety of differing threats with variable impacts. table 1. public health emergency declarations – select examples date jurisdiction d e c l a r i n g person/entity purpose/ reason brief summary 9/2/05 state of louisiana gov. kathleen b. blanco hurricane katrina declaration of phe to suspend outof-state licensure for medical professionals and personnel. due to statewide shortage of medical professionals and personnel following hurricane katrina. la. exec. order no. kbb 2005-26. 5/6/08 pima county (az) cnty. bd. of supervisors measles outbreak proclamation of the existence of a phe. county resolution ratified the local proclamation made on may 1, 2008. pima cnty. bd. of supervisors res. no. 2008-107. 10. lawrence o. gostin, proposed draft: the model state emergency health powers act § 104(m), the ctr. for law & pub.’s health at georgetown & johns hopkins univ., (dec. 21, 2001) http://www.publichealthlaw.net/msehpa/msehpa.pdf [https://perma.cc/l3hs-nyyk]. 11. the ctr. for law & pub.’s health at georgetown & johns hopkins univ., the model state emergency health powers act (msehpa) state legislative activity 1 (2006) (noting that by 2006, thirty-eight states’ legislatures had passed bills related to the act), h t tp : / /www.pub l ich ea l th l aw.n e t /msehp a/msehp a%2 0 leg%20act ivi ty.pdf [https://perma.cc/j95g-8pd3]; see also network for public health, the model state emergency health powers act summary matrix 7 (2011), https://www.networkforphl.org/ _asset/80p3y7/western-region---msehpa-states-table-8-10-12.pdf [https://perma.cc/nn6tgjyj] (noting that in 2011, the network for public health law reported that 26 states and d.c. had legislatively crafted phes, or like terms, as part of their laws. prior to 2001, virtually no state featured this type of emergency classification). 2018] from [a]nthrax to [z]ika 27 date jurisdiction d e c l a r i n g person/entity purpose/ reason brief summary 4/26/09 united states (u.s.) acting hhs sec’y. charles e. johnson h1n1 outbreak phe determination. phe to address swine influenza declared via the public health service act, 42 u.s.c. §247d. 6/17/09 town of libby (mt) epa admin. lisa p. jackson release & threatened release of amphibol e asbestos determination and findings of phe for the libby asbestos site in lincoln county, montana. declaration made under the comprehensive environmental response, compensation, and li a b i l i t y ac t ( c e r c la) §104(a)(4). 10/5/10 city of oakland (ca) oakland city council shortage of affordable & safe medical cannabis resolution renewing the city council's declaration of a local phe with respect to safe, affordable access to medical cannabis in the city of oakland. oakland city council. res. no. 82994. 2/4/11 marquette county (mi) cnty. health dept. use of designer drugs (bath salts) emergency order to prevent imminent danger to health or lives. marquette cnty. health dep't. order.12 3/9/12 cnty. of hawai'i (hi) council of the cnty. of hawai’i food insecurity emergency ordinance that finds and declares that a phe exists and makes an emergency appropriation of $200,000 to alleviate hunger. cnty. of haw. ordinance no. 1235. 8/9/12 dallas county (tx) judge clay jenkins west nile virus outbreak phe declared to help control mosquito populations and address the crisis. 13 12. see cdc, emergency department visits after use of a drug sold as “bath salts” (may 2 0 , 2 0 1 1 ) h t t p s : / /www.cd c .go v/mmwr/preview/mmwrhtml /mm60 1 9a6 .h tm [https://perma.cc/9svc-ec28]. 13. west nile crisis: public health emergency, a conversation with judge clay jenkins, mosquito control mag., summer 2013, at 8, http://www.town.boxford.ma.us/pages/ boxfordma_boh/mosquitos/mosqcontrolsummer2013.pdf [https://perma.cc/x6ws-w942]. 28 indiana health law review [vol. 15:23 date jurisdiction d e c l a r i n g person/entity purpose/ reason brief summary 1/12/13 state of new york governor andrew m. cuomo severe flu season executive order declaring a disaster emergency in the state of new york and temporarily authorizing pharmacists to immunize children against seasonal influenza. n.y. exec. order no. 90. 3/27/14 commonwealth of massachusetts gov. deval patrick opioid addiction epidemic phe declaration. declaration made to prevent escalation of the epidemic and aid in addict recovery.14 10/7/14 state of connecticut gov. daniel p. malloy ebola phe declared via conn. g. s. § 1 9 a 1 3 1 t o p r o v id e t h e commissioner of public health and other officials with all authorities necessary to prevent any potential transmission of the ebola virus. 3/26/15 scott county (in) gov. mike pence (3/26/15) health comm’r. jerome adams (5/21/15) hiv outbreak executive order declaring a phe. the state health commissioner then declared and extended the phe in scott cnty. together, these declarations allowed the scott cnty. health dept. to administer a needle exchange program to combat hiv. ind. exec. order 15-05. 10/20/15 calaveras and lake counties (ca) ca. dept. of public health sec’y. karen l. smith aftermath of wildfires declaration of health emergency. declaration made pursuant to ca health and safety code § 101080 to address debris and hazardous material in ash resulting from wildfires. 12/15/15 city of flint (mi) mayor karen weaver gov. rick snyder (1/5/16) lead levels in drinking water declaration of state of emergency. the declaration mobilized the national guard to distribute water supplies. 14. press release, deval patrick, governor patrick declares public health emergency, announces actions to address opioid addiction epidemic (mar. 27, 2014) http://archives.lib.state.ma.us/bitstream/handle/2452/207588/ocn795183245-2014-0327b.pdf?sequence=1&isallowed=y [https://perma.cc/ja47-s5mt]. 2018] from [a]nthrax to [z]ika 29 date jurisdiction d e c l a r i n g person/entity purpose/ reason brief summary 2/12/16 state of hawai’i gov. david y. ige dengue fever emergency proclamation to fight dengue fever authorized under hawai'i rev. stat. § 127. 8/12/16 puerto rico hhs sec’y. sylvia m. burwell zika virus determination that a phe exists in puerto rico as a consequence of the zika virus outbreak. at the request of p.r. gov. padilla, hhs secretary declared a phe of national significance. government declarations supported emergency response efforts in natural disasters like hurricanes katrina and rita (2005) and later isaac and sandy (2012). the spread of novel, infectious diseases (an original target of msehpa) also garnered declarations, notably including the 2009/2010 h1n1 pandemic. localized outbreaks of infectious conditions, such as a 2012 uptick in human cases of west nile virus in dallas county, texas, also led to declared states of phe. these sorts of declarations fell within the scope of pre-conceived notions reflected in msehpa as to what constitutes a phe sufficient to enhance local, state, or federal public health powers. however, lawmakers and executive officials also viewed an array of additional conditions or circumstances as phes that were arguably far outside the scope of the originally-crafted definition in msehpa. these include phe declarations in cases of contamination of public water supplies, release of amphibole asbestos, domestic violence, shortages of affordable and safe medical cannabis, severe storms and tornadoes, food insecurity, opiate addiction, and wildfires. though existing routine public health powers may sufficiently authorize response efforts to these public health threats, they were nevertheless classified as phes, potentially implicating civil rights infringements for little to no public health gain. to the extent phe powers should be used only when justified and for limited duration, the invocation of declarations across a swath of conditions or threats reflects a shift in policy over time that may ultimately dilute emergency response efforts. iii. public health emergencies as national security threats on april 1, 2016, former president barack obama proclaimed that public health is the key to national security and well-being at home and abroad. his15 views were not merely aspirational. they are consistent with an emerging trend among federal leaders and agencies to classify phes as threats to national 15. press release, office of the white house press sec’y, presidential proclamation: nat’l pub. health week, 2016 (apr. 1, 2016), https://www.whitehouse.gov/the-pressoffice/2016/04/01/presidential-proclamation-national-public-health-week-2016 [https://perma.cc/9kep-mlc9]. 30 indiana health law review [vol. 15:23 security. federal authorities to address national security are grounded in multiple constitutional provisions, clarified in statutory enactments, and extended well16 17 beyond the president. 18 in the late 1980s nsts began to increasingly include infectious diseases, bioterrorism, and environmental degradation. in january 2000, the central19 intelligence agency (cia) detailed several impacts on national security of infectious diseases, including the potential for a high number of deaths, economic setbacks, delays in political developments, travel restrictions, and heightened probability of domestic attacks. since this report, multiple public health threats20 have garnered some level of national security designation under three common21 16. see u.s. const. art. 1, § 8 (establishing the national defense as an exclusive federal role and authorizing congress to declare war and provide for the common defense); see also u.s. const. art. 2 § 2 (establishing the president as commander in chief); see also u.s. const. art. 4 § 4 (guaranteeing a republican form of government and state protection from invasion). 17. see, e.g., the nat’l sec. strategy archive (last visited aug. 27, 2017), http://nssarchive.us [https://perma.cc/4ksk-b4sl]. the national security act of 1947, 50 u.s.c. § 401 (2012), established the national security council (nsc) and central intelligence agency (cia), and restructured military forces to gather data and contribute to executive responses. nsc is tasked with advising the president on foreign and domestic matters of national security to appropriately coordinate effective plans and responses. the defense production act of 1950, 50 u.s.c. §§ 4501-4568 (2015), empowers the president to protect national security interests by allocating materials, services, and facilities to promote national defense, and controlling market forces in crises. the goldwater-nichols defense department reorganization act of 1986, 50 u.s.c. § 404(a) (2012), requires the president to submit to congress an annual national security strategy report and budget proposal that frames security threat responses, interests, and goals each year. 18. see project bioshield: progress in the war on terror, the white house: president george w. bush (2004), http://georgewbush-whitehouse.archives.gov/infocus/bioshield [https://perma.cc/679l-gqtn]. the foreign assistance act (faa) of 1961, 22 u.s.c.a. § 2151 (1974), authorizes coordinated efforts of nsc and department of defense (dod) to provide humanitarian aid abroad. the project bioshield act in 2004, 42 u.s.c. § 247d-6b (2004), seeks to improve public health infrastructure and medical countermeasures related to chemical, biological, radiological, or nuclear (cbrn) threats and increase bio-surveillance of harmful pathogens. it authorizes dhs’ secretary to issue material threat determinations regarding a cbrn event to fund essential countermeasures. 42 u.s.c. § 247d-6b(c)(2) (2012). in 2004, dhs received $5.6 billion to use over ten years to purchase next-generation countermeasures against anthrax, smallpox, and other biothreats classified as mtds. 19. david p. fidler, public health and national security in the global age: infectious diseases, bioterrorism, and realpolitik, 35 geo. wash. int’l l. rev. 787, 791-92 (2003). 20. the global infectious disease threat and its implications for the united states, nat’l intelligence council, nie 99-17d, 10 (jan. 2000) [hereinafter the global infectious disease threat], http://www.fas.org/irp/threat/nie99-17d.htm [https://perma.cc/8ed9-dkdc]. 21. jennifer brower & peter chalk, the global threat of new and reemerging infectious diseases: reconciling u.s. national security and public health policy, (rand 2003) https://www.rand.org/content/dam/rand/pubs/monograph_reports/ 2018] from [a]nthrax to [z]ika 31 classifications (see table 2). table 2. national security classifications national security threat national security priority material threat determination systemic threat to domestic, regional, or global health or safety, or political, civil, or economic security, requiring significant add i t ional resources, planning, and action by the u.s. (and other nations).22 determination that potential humanitarian, economic, or political losses support a heightened level of national attention by the president, hhs, dhs, nsc, dod, or other federal entity.23 dhs determination that cbrn agent poses a plausible threat to a significant number of american lives, permitting hhs to utilize bioshield reserve funds for necessary countermeasures.24 in 2002, the national intelligence council (nic) projected that hiv/aids would seriously implicate national security interests as the disease spread to more populous countries. president bill clinton initiated federal efforts to25 significantly increase the hiv/aids global prevention budget, accelerate vaccination research, mobilize new resources, and encourage international humanitarian efforts. later, in 2003, president george w. bush created the26 president’s emergency plan for aids relief (pepfar), to fund treatment and mr1602/mr1602.pref.pdf [https://perma.cc/ena8-ns77]. 22. exec. order no. 13,691, 80 fed. reg. 9,349 (feb. 20, 2015). see also press release, the white house office of the press sec’y, remarks by the president after meeting on ebola (oct. 6, 2014), https://www.whitehouse.gov/the-press-office/2014/10/06/remarks-president-after-meetingebola [https://perma.cc/qc74-2c42]. 23. james g. hodge, jr. & kim weidenaar, public health emergencies as threats to national security, 9 j. nat’l security l. & pol’y 81, 86 (2017) http://jnslp.com/wpcontent/uploads/2017/04/public_health_emergencies_as_threats_to_national_security_fina l.pdf [https://perma.cc/pl3v-k87r]. see also tom friedman, executive order issued on one of the most urgent health concerns facing us today, dep’t of health & hum. serv. (sept. 19, 2014), http://www.hhs.gov/blog/2014/09/executive-order-issued-combating-antibiotic-resistantbacteria.html; sylvia mathews burwell, our response to the ebola crisis, dep’t of health & hum. serv. (sept. 17, 2014), http://www.hhs.gov/blog/2014/09/our-response-ebola-crisis.html. 24. staff of h. comm. on homeland security, subcomm. on emergency preparedness, response, & communications, 112th cong. (2011) (testimony of segaran pillai, ph.d., chief med. and sci. advisor, directorate chem. and biological def. div., dep’t of homeland sec.), https://homeland.house.gov/fi les/test imony%20pillai_0.pdf [https://perma.cc/8q8x-87vs]. 25. the next wave of hiv/aids: nigeria, ethiopia, russia, india, and china, nat’l intelligence council, ica 2002-04d (sept. 2002), https://fas.org/irp/nic/hiv-aids.html [https://perma.cc/q97s-awac]. 26. the white house, a national security strategy for a global age (dec. 2000), http://nssarchive.us/nssr/2001.pdf [https://perma.cc/j23k-flh4]. 32 indiana health law review [vol. 15:23 prevention measures for millions of persons largely in african countries. 27 diseases like severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers), multi-drug-resistant tuberculosis (mdr-tb), and pandemic influenzas have equally been classified as national security priorities. president obama identified antibiotic-resistant bacteria as a national security and public health priority in 2014 via an executive order that outlined cross-sector efforts and investments to prevent and control outbreaks. on28 september 22, 2006, dhs issued a material threat determination for ebola viral disease (evd) on grounds of national security. almost a decade later, president29 obama described evd as a nst in october 2014 to support federal aid through30 military health-related operations and funding for research, supplies, and biosurveillance. on february 26, 2016, former secretary of the department of31 health and human services (hhs), sylvia burwell, stated that zika virus has “. . . significant potential to affect national security or the health and security of united states citizens living abroad . . . ,” justifying action by hhs consistent32 with national security implications. 33 despite these and other examples of public health threats labeled under national security nomenclatures, predicting what qualifies as a nst remains difficult given their classified nature. multiple criteria supporting these determinations include the: (1) existence of a potential or current threat to political, economic, and social stability; (2) limitations of civic and social participation stemming from the threat; (3) potential diminutions in military power; (4) capacity of the threat to exceed transnational borders; (5) systemic human rights abuses; and (6) insufficiencies of global public health responses.34 regardless of the justification, classification of phes as nsts has the capacity to change the nature of response efforts by increasingly “federalizing” these events. characterizing phes as nsts constitutionally stops state and local 27. the henry j. kaiser family foundation, the u.s. president’s emergency plan for aids relief (pepfar) (june 2014), https://kaiserfamilyfoundation.files.wordpress.com/ 2014/06/8002-05-the-u-s-presidents-emergency-plan-for-aids-relief-pepfar1.pdf [https://perma.cc/5egc-cjj5], (noting that congressional budget appropriations under pepfar peaked at $6.9 billion under president obama in 2010). 28. exec. order no. 13,676, 79 fed. reg. 56,931 (sept. 18, 2014). 29. declaration regarding emergency use of in vitro diagnostics for detection of ebola virus, 79 fed. reg. 47,141 (aug. 12, 2014). 30. press release, remarks by the president after meeting on ebola, supra note 22. 31. jane evans, pandemics and national security, 1 global sec. stud. 100 (2010), http://globalsecuritystudies.com/evans%20pandemics.pdf [http://perma.cc/392b-tjec]. 32. 81 fed. reg. 10,878, 10,879 (mar. 2, 2016) (emphasis added). 33. sylvia m. burwell, determination that a public health emergency exists in puerto rice as a consequence of the zika virus outbreak, dep’t of health & human sers. (aug. 12, 2016), http://www.phe.gov/emergency/news/healthactions/phe/pages/zika-pr.aspx [http://perma.cc/p4evt3qt] (noting that five months later, on august 12, 2016, hhs’ secretary burwell declared a phe related to the spread of zika virus in puerto rico). 34. see e.g., hodge & weidenaar, supra note 23, at 94. 2018] from [a]nthrax to [z]ika 33 governments from implementing public health efforts that they traditionally might have undertaken, or at least shared with federal authorities previously. in the years ahead, this jurisdictional shift of power promises to change the game regarding national phe management, preparedness, and response. iv. expansion of federal social distancing powers creating social distances between infectious individuals and at-risk communities is a long-standing and essential measure to counter public health repercussions of emerging infectious diseases such as sars (2003), h1n135 (2009), evd (2014), and mers (2014). like the ongoing shift to respond36 37 38 to these types of threats as nsts, federal powers to apprehend, quarantine, and isolate individuals have undergone major revisions following decades of almost archaic notions of their exercise nationally. 39 for decades under the public health service act (phsa), hhs secretary can take measures to prevent infectious agents from entering and spreading across the country. corollary federal regulations authorize cdc to detain, medically40 examine, and release persons travelling into the u.s., or between states, that are reasonably suspected of carrying specific communicable diseases listed via41 federal executive order. though issuance of federal social distancing orders has42 been historically rare, prior examples reveal embedded deficiencies. 43 in 2007, local public health authorities in georgia asked atlanta-based attorney andrew speaker to forgo his planned travels after determining he may be infected with extreme drug resistant tuberculosis (xdr-tb). cdc officials44 35. timeline: sars outbreak, cnn (apr. 24, 2003, 8:29 am), http://www.cnn.com/ 2003/health/04/24/timeline.sars/ [http://perma.cc/k9fs-y6us]. 36. the 2009 h1n1 pandemic: summary highlights, april 2009-april 2010, ctrs. for disease control & prevention (last updated june 16, 2010), https://www.cdc.gov/h1n1flu/ cdcresponse.htm [http://perma.cc/qb4t-4mdv]. 37. ebola: mapping the outbreak, bbc news (jan. 14, 2016), http://www.bbc.com/news/ world-africa-28755033 [http://perma.cc/e7cj-vp86]. 38. press release, cdc announces first case of middle east respiratory syndrome coronavirus infection (mers) in the united states, ctrs. for disease control & prevention (may 2, 2014) [hereinafter cdc announcement], https://www.cdc.gov/media/releases/2014/p0502us-mers.html [http://perma.cc/7rsr-j873]. 39. history of quarantine, ctrs. for disease control & prevention (last updated july 31, 2014), https://www.cdc.gov/quarantine/historyquarantine.html [http://perma.cc/3v3g-x95s]. 40. pub. health serv. act, 42 u.s.c. § 6a (2016). 41. legal authorities for isolation and quarantine, ctrs. for disease control & prevention (aug. 2015), http://www.cdc.gov/quarantine/aboutlawsregulations quarantineisolation.html [https://perma.cc/f29d-kw8c]. 42. exec. order no. 13,295, 68 fed. reg. 68 (apr. 4, 2003). 43. quarantine stations, ctrs. for disease control & prevention (last updated jan. 15, 2014), https://www.cdc.gov/quarantine/quarantinestations.html [https://perma.cc/s3he-pzj6]. 44. vikki valentine, a timeline of andrew speaker’s infection, npr (june 6, 2007), http://www.npr.org/news/specials/tb/ [https://perma.cc/m6rk-lm3z]. 34 indiana health law review [vol. 15:23 stepped in when speaker rebuffed local requests and travelled to several european countries for his honeymoon over a lengthy period of days. amidst a barrage of international publicity, speaker eventually flew to canada, was apprehended by cdc agents after crossing the u.s. border into new york, and was flown and isolated at a denver hospital for several weeks where he was treated for what was ultimately determined to be less serious form of drugresistant tb. speaker’s case illustrated the limits of federal authorities, working in concert with local health officials, in cdc’s own backyard. federal social distancing powers have been more prominently exercised in widespread outbreaks constituting phes. in 2014, an international outbreak of mers reached the u.s. when two infected individuals returned from abroad.45 their conditions went undetected for several days, ultimately entailing case investigations of over 700 close contacts and costing over $250,000. later that46 year, evd reached the u.s. after spreading rapidly from west africa through major international transportation hubs. an infected liberian, thomas eric duncan, went undetected through international travels to visit family in dallas, texas. he later died at a texas hospital where two of his treating nurses also47 became infected with evd. subsequently, over 35,000 travelers underwent health screenings at u.s. airports between october 2014 and the end of the outbreak. despite enormous costs of such long-term screenings, no incoming evd cases were actually detected through these routes.48 increased societal mobilization meshed with complex infectious diseases with little to no effective treatments (at least initially) necessitated modernization of cdc’s social distancing powers. the agency attempted for years to reform its provisions. in 2005, it proposed the detainment of individuals up to three business days pending issuance of a federal social distancing order. extensive public49 concerns grounded in enforcement and monitoring responsibilities for airlines and civil liberties infringements led to the abandonment of this proposal. in 2012, cdc broadened several of its existing regulations’ definitions without substantively upgrading its authority.50 following months of regulatory process beginning in 2015, including a major overhaul of an initial draft circulated in august 2016 (see table 3), hhs/cdc51 45. cdc announcement, supra note 38. 46. control of communicable diseases, 81 fed. reg. 54,229 (proposed aug. 15, 2016). 47. greg botelho & jacque wilson, thomas eric duncan: first ebola death in u.s., cnn (oct. 8, 2014), http://www.cnn.com/2014/10/08/health/thomas-eric-duncan-ebola/ [https://perma.cc/9wzf-uzv3]. 48. james g. hodge, jr. et al., federal powers to control communicable conditions: call for reforms to assure national preparedness and promote global security, 15 health security 123 (2017). 49. control of communicable diseases, 70 fed. reg. 71,892, 71,895 (proposed nov. 30, 2005). 50. control of communicable diseases: interstate; scope and definitions, 77 fed. reg. 75,936, 75,937 (proposed dec. 26, 2012). 51. see ctrs. for disease control & prevention, supra note 43. https://doi.org/10.1089/hs.2016.0114 2018] from [a]nthrax to [z]ika 35 issued its final rule to modernize regulations on january 19, 2017, just one day52 prior to the inauguration of president trump. the final rule authorizes federal public health prevention measures at transportation hubs (e.g., airports, seaports, railway stations, and bus terminals). travelers may be subject to prevention53 measures, and asked to provide contact, travel, and health information. in54 general, infected individuals may not engage in interstate or international travel without a federal travel permit.55 “ill person” is defined broadly in the rule to include virtually anyone with signs or symptoms of a communicable disease. cdc officials can apprehend,56 isolate, quarantine, or conditionally release any individual upon “reasonable beliefs” that the person is infected with a quarantinable communicable condition listed via the aforementioned executive order. they may be subject to a57 medical examination by a licensed hcw and tested as reasonably necessary to confirm or rule out an infectious condition.58 table 3. cdc’s 2017 final rule change 2017 final rule removed requirement that individuals unilaterally agree to submit to measures including hospitalization, vaccination, and medical treatment added requirement that cdc agents reassess a social distancing order within 72 hours of issuance to determine whether less restrictive measures would fulfill the public health objective added requirement that medical examinations be conducted by a licensed health worker only upon informed consent modified definition of “non-invasive” to replace “physical inspection” with “visual inspection” added requirement that cdc provide certain accommodations, medical treatment, and means of communications for affected individuals added a right to legal counsel by revising the term “representatives,” and ensuring the appointment of counsel to indigent individuals added a right to appeal where affected individuals can present witnesses and introduce expert testimony modified the threshold for who may be considered indigent from 150% of the federal poverty level to 200% added requirement that cdc must respond to requests for travel permits within 5 business days, and to repeals of denials within 3 business days 52. control of communicable diseases, 82 fed. reg. 6890 (jan. 19, 2017). 53. id. at 6891. 54. id. at 6892. 55. id. at 6891. 56. id. at 6892, 6893. 57. exec. order no. 13,295, 68 fed. reg. 17,255 (apr. 4, 2003). 58. control of communicable diseases, 82 fed. reg. 6891 (jan. 19, 2017). 36 indiana health law review [vol. 15:23 how the final rule may be implemented by cdc agents in collaboration with state and local public health authorities is unclear. it now has the ability to deploy its social distancing measures without advance notice or approval of regional public health entities, although cdc may still seek such input as a matter of practice. the rule may be vulnerable to legal challenges depending how59 cdc actually exercises its authority. cdc’s broad definition of “ill person” may unnecessarily capture persons who present little to no risk to societal public health. cdc’s insistence on basing its social distancing powers on a “reasonable belief” standard is an affront to evidentiary standards in violation of substantive due process principles. additionally, the rule fails to guarantee review of60 medical decisions outside cdc by a neutral decision-maker–a general staple of due process. affected individuals can, however, seek impendent medical review61 on their own accord. ultimately, cdc’s updated regulations may only protect the public’s health provided that exercises comport with respect for individual and community rights. v. the liability “sinkhole” among the most contentious issues in emergency preparedness is liability.62 health care and public health practitioners, volunteers, and others are concerned about their personal liability for patients’ or others’ injuries or deaths in emergencies. hospitals, clinics, public health agencies, and nonprofits worry63 about potential exposure to liability for their acts or omissions. some suggest64 these fears are unwarranted given that unscrupulous liability claims during and after phes are scarce. conversely, hcws point to significant liability claims65 in national cases involving workers trying to serve or treat patients with limited66 resources in dire circumstances. actual costs of liability exposure during and after emergencies are difficult to measure and assess, but collateral damages correlated to perceptions of risks are demonstrable. numerous studies illustrate that health practitioners are unwilling to serve during emergencies because of potential liability. countless67 59. control of communicable diseases, 82 fed. reg. 6890 (jan. 19, 2017). 60. lawrence gostin & james g. hodge, jr., reforming federal public health powers: responding to national and global threats, 317:12 jama 1211, 1212 (mar. 28, 2017). 61. id. 62. george j. annas, standard of care—in sickness and in health and in emergencies, 352 new eng. j. med. 2126 (2010). 63. id. 64. id. 65. id. 66. christopher drew & shaila dewan, louisiana doctor said to have faced chaos, n.y. times (july 20, 2006), http://www.nytimes.com/2006/07/20/us/20doctor.html [https://perma.cc/rz44-2ls]. 67. michealle carpenter et. al., deploying and using volunteer health practitioners in response to emergencies: proposed uniform state legislation provides liability protections and workers’ compensation coverage, 3 am. j. disaster med. 17 (2008). https://doi.org/10.1001/jama.2017.1021 https://doi.org/10.1056/nejmhle1002260 2018] from [a]nthrax to [z]ika 37 anecdotal data suggest that the mere threat of liability drives many hcws or entities away from participating in phe response efforts. the institute of68 medicine (iom) suggested in its 2009 report that “. . . state and local governments should explicitly tie existing liability protections (e.g., through immunity or indemnification) for healthcare practitioners and entities to crisis standards of care.”69 to date, however, there are no comprehensive national liability protections for hcws, volunteers, or entities in all emergency settings. instead, a patchwork of liability protections exists across all levels of government covering practitioners and entities—particularly volunteers and government entities and officials—who act in good faith and without willful misconduct, gross negligence, or recklessness. these emergency liability protections may70 immunize or indemnify individuals or entities from specific claims or monetary damages. for example, in the last decade, all states executed the emergency management assistance compact (emac), which provides strong liability protections for state or local agents during declared emergencies. limited71 waivers of sanctions or fines for failing to comply with federal or state laws during emergencies offer additional protections.72 in 2005, congress enacted the public readiness and emergency preparedness (prep) act to protect specific entities and individuals implementing certain73 covered medical countermeasures. upon a prep act declaration by hhs’74 secretary, immunity from tort liability is extended to “covered persons” (e.g., federal officials, manufacturers, drug distributors, pharmacies, and state and local program planners) involved in the development, distribution, and administration 68. james g. hodge, jr. et. al., practical, ethical, and legal challenges underlying crisis standards of care, 41(s1) j.l. med. & ethics 50, 52, 54 (2013). 69. institute of medicine committee on guidance for establishing standards of care for use in disaster situations, guidance for establishing crisis standards of care for use in disaster situations: a letter report, at 49 (2009); james g. hodge, jr., dan hanfling & tia p. powell, practical, ethical, and legal challenges underlying crisis standards of care, 41(s1) j. of l. med. & ethics 50 (2013). 70. sharona hoffman, responders’ responsibility: liability and immunity in public health emergencies, 96 geo. l.j. 1913 (2008); sara rosenbaum et. al, state laws extending comprehensive legal liability protections for professional health-care volunteers during public health emergencies, 123 pub. health rep. 238, 239 (2008); tfah liability protections relevant statutes, trust for american health (2008), http://healthyamericans.org/reports/bioterror08/ pdf/legal-preparedness-law-review-of-state-statutes-and-codes.pdf [https://perma.cc/5s7m-54jd]. 71. emergency management assistance compact, pub. l. no. 104-321, 110 stat. 3877 (1996). 72. 42 u.s.c. § 1320b-5 (2008). 73. public readiness and emergency preparedness act, pub. l. 109-148, 119 stat. 2680 (2005); see also 42 u.s.c. § 247d-6d. 74. peggy binzer, the prep act: liability protection for medical countermeasure development, distribution, and administration, 6 biosecurity & bioterrororism: biodefense strategy, prac. and sci. 293 (2008). https://doi.org/10.1111/jlme.12039 https://doi.org/10.1177/003335490812300219 https://doi.org/10.1089/bsp.2008.1112 38 indiana health law review [vol. 15:23 of medical countermeasures. the prep act also establishes a compensation75 fund for individuals injured from the administration or use of covered countermeasures. though strong, these liability protections only apply to76 persons and covered countermeasures specified by hhs, for a specific period of time, and for acts of negligence, not intentional or criminal acts. despite some gaps, existing federal, state, and local laws collectively provide an umbrella of liability protections, sheltering hundreds of thousands of hcws, volunteers, and entities that play by the rules. still, these protections have77 neither placated hcws (seeking complete immunity) nor dissuaded patient-rights advocates (seeking equal access to courts to adjudicate potential negligence claims). many lawand policy-makers believe that subjecting practitioners and78 entities to unforeseen claims for negligent acts or omissions for their emergency responses in the chaos of emergencies runs counter to government protections of the public’s health. absent strong liability protections, hcws simply will not show up and participate in emergency efforts. while patients’ access to judicial relief may be negatively impacted (absent victims’ relief funds), providing stronger liability protections to incentivize responders has emerged as a dominant policy objective of federal, tribal, state, and local governments. 79 vi. public health legal preparedness and routine public health practices one of the upsides of phe legal preparedness is the potential for lessons learned in emergencies to translate to routine public health practices. public and private sectors often incorporate efficacious policies in emergency responses into day-to-day public health laws and practices. social distancing measures, including isolation and quarantine, are a primary example. isolation and quarantine measures generated from emergencies or crises responses to infectious conditions are often applied in routine practice. due process measures explicitly built into msehpa for purposes of assuring constitutionally sound quarantine and isolation efforts were also embedded two years later into the turning point model state public health act of 2003, which 75. id. at 293. 76. countermeasures injury compensation program, u.s. dep’t of health &human servs. (last updated feb. 2017), https://www.hrsa.gov/cicp/cicpfactsheet.pdf [https://perma.cc/42kc-x2ca]. 77. table – legal liability protections for emergency medical/public health responses, network for pub. health law (as of feb. 20, 2017), https://www.networkforphl. org/_asset/xbt7sg/liability-protections-for-emergency-response.pdf [https://perma.cc/w5s7jrx3]. 78. on august 9th, 2011, the american bar association (aba) house of delegates approved resolution 125 to oppose adoption of laws, particularly immunity provisions, which “would alter the legal duty of reasonable care in the circumstances owed to victims of a natural or manmade disaster by relief organizations or health care practitioners.” american bar association, report to the house of delegates on resolution 125 (2011). 79. institute of medicine, supra note 69, at 48-50. 2018] from [a]nthrax to [z]ika 39 in turn was adopted for routine practices among multiple states. modern state80 requirements for hcws to receive flu or other vaccinations also derive from emergency policies. after the 2009 h1n1 influenza outbreak in new york, the state health department required hcws at hospitals, home health care agencies, and hospice care centers to be vaccinated for seasonal flu and h1n1. other81 states soon followed. as of 2015, 18 states had similar requirements.82 expanded scopes of practice allowing pharmacists to administer vaccines also has its roots in contagious disease responses. msehpa, for example, would allow for sufficient expansion of scope of practice limitations among pharmacists in declared phes to allow them to directly administer vaccines. in 1996 the83 mississippi department of public health asked the mississippi pharmacists association to help combat seasonal adult influenza by training pharmacists to administer vaccines. over the next decade many other states began passing84 practice laws allowing pharmacists to administer flu vaccines, as well as common childhood vaccines like pertussis and mmr. pharmacists can administer85 multiple types of vaccines in 46 states; the remaining four (nh, ny, wv, wy) limit vaccines to influenza.86 new and investigational drugs used during pandemic responses are often later incorporated into general public health practice. the food and drug administration (fda) is authorized to issue emergency use authorizations (euas) during emergency circumstances that involve chemical, biological, 80. james g. hodge, jr. et al., transforming public health law: the turning point model state public health act, 34 j. l., med., & ethics 77 (spring 2006). 81. anemona hartocollis, state requires flu vaccination for caregivers, n.y. times (aug. 18, 2009), http://www.nytimes.com/2009/08/19/health/policy/19swine.html?scp= 6&sq=flu&st=csenew%20rule%20adopted [https://perma.cc/96qf-ne7l]. 82. chyongchiu jeng lin et al. association of state laws and healthcare workers’ influenza vaccination rates. 108 j. nat’l med. ass’n. 99 (2016); ctrs. for disease control & prevention, menu of state hospital influenza vaccination laws (2015), https://www.cdc.gov/phlp/docs/menu-shfluvacclaws.pdf [https://perma.cc/hvu8-wxpz]. 83. model state emergency health powers act § 603(a)(1) (2001). 84. michael d. hogue et al., pharmacist involvement with immunizations: a decade of professional advancement, 46 j. am. pharm. ass’n 168,169-70 (2006). 85. cason schmit & allison reddick, pharmacist vaccination laws map, law atlas, http://legacy.lawatlas.org/query?dataset=pharmacist-vaccination [https://perma.cc/r9md-r2jq] (last visited on sept. 8, 2017); amanda schaffer, should you go to the drugstore for your flu shots? slate, (oct. 17, 2012), http://www.slate.com/articles/double_x/doublex/2012/10/ vaccines_at_the_pharmacy_states_should_let_drugstores_give_shots.html [https://perma.cc/tb4e3d2a]; sewell chan, should pharmacists give flu shots?, n.y. times (mar. 5, 2008, 12:15 pm), https://cityroom.blogs.nytimes.com/2008/03/05/should-pharmacists-give-flu-shots/ [https://perma.cc/wh8r-s4by]. 86. krystalyn weaver, pharmacist-administered immunizations: what does your state allow?, pharmacy today (oct. 2015), https://www.pharmacist.com/sites/default/files/files/1015_ pt_63a.pdf [https://perma.cc/eh2z-xpef]. https://doi.org/10.1111/j.1748-720x.2006.00010.x https://doi.org/10.1016/j.jnma.2015.12.013 https://doi.org/10.1331/154434506776180621 40 indiana health law review [vol. 15:23 radiological, or nuclear agents. euas allow responders to use otherwise-87 unapproved lifesaving preventatives, treatments, and tests in response to emergency situations. in the midst of the h1n1 pandemic in 2009, fda issued88 an eua for the antiviral peramivir to treat h1n1 intravenously. the agency89 eventually approved the drug fully in 2014.90 phes involving non-communicable diseases may also catalyze changes in routine public health practice. as noted in table 1, in march 2014, massachusetts governor deval patrick declared a phe in response to an increase in heroin and opioid overdoses. emergency responders were authorized to carry naloxone, an91 overdose reversal medication. pharmacies were allowed to dispense the drug92 without a prescription. with opiate overdose numbers skyrocketing nationally,93 94 many states have similarly changed their policies to make naloxone more easily available. as of 2016, 45 states allow third party individuals to receive a prescription for naloxone; 33 states and the district of columbia allow95 pharmacies to dispense naloxone without a prescription.96 syringe exchange programs (seps) represent another cross-over from emergencies to routine practice. in 1993, the city of san francisco declared a local emergency and exempted the city and county from state laws regarding 87. emergency use authorization of medical products and related authorities, food & drug admin. (january 2017), https://www.fda.gov/regulatoryinformation/guidances/ucm125127. htm [http://perma.cc/g4pb-r5du]. 88. id. 89. authorization of emergency use of the antiviral product peramivir accompanied by emergency use information; availability, 74 fed. reg. 56644 (nov. 2, 2009). 90. fda approves rapivab to treat flu infection, food & drug admin (dec. 22, 2014), http://web.archive.org/web/20170217030115/http://www.fda.gov/newsevents/newsroom/press announcements/ucm427755.htm [https://perma.cc/4cn5-9zzj]. 91. brian macquarrie, governor declares an emergency on opiate abuse, boston globe (mar. 27, 2014), https://www.bostonglobe.com/metro/2014/03/27/with-heroin-overdoses-rise-govpatrick-declares-public-health-emergency-mass/hoajtijnknshkanwjz6wyl/story.html [https://perma.cc/th93-7ev3]. 92. id. 93. richard valdmanis, massachusetts declares heroin emergency, looks to anti-overdose drug, reuters (mar. 27, 2014, 5:00 pm), http://www.reuters.com/article/us-usa-heroinmassachusetts-idusbrea2q25d20140327 [https://perma.cc/qqq3-9zlr]. 94. opioids: the prescription drug & heroin overdose epidemic, dep’t of health & human servs., https://www.hhs.gov/opioids/ [https://perma.cc/27cd-gzlg] (last visited sept. 4, 2017). 95. naloxone overdose prevention laws, prescription drug abuse policy sys., http://pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139 [https://perma.cc/str7-cqgx] (last visited july 1, 2017). 96. walgreens expands availability of naloxone without a prescription, am. pharmacists ass’n (dec. 22, 2016), https://www.pharmacist.com/article/walgreens-expands-availabilitynaloxone-without-prescription [https://perma.cc/zn2v-mexy]. 2018] from [a]nthrax to [z]ika 41 syringe distribution. seps have since proven extremely effective at combatting97 the spread of hiv/aids. sixteen states now explicitly authorize needle98 exchanges. indiana allows seps in a declared state of emergency, which former99 governor mike pence used to abate an epidemic of hiv in a small rural area of the state in 2015 following mass exposures via injecting drug users. in 2016,100 the federal consolidated appropriations act opened the door for state and local101 jurisdictions to use federal funds to implement seps if they can prove their jurisdiction is experiencing, or at risk for, hepatitis or hiv outbreaks resulting from injected drug use. the trump administration has not made official102 statements about seps or their continued federal funding. 103 efforts to contain zika virus have also led to public health innovations that may set new standards for public health practices. as zika-carrying mosquitos (aedes aegypti) are more active during the day, traditional mosquito vector control methods, like insecticide–treated bed nets used to combat malaria, are ineffective. other mosquito abatement efforts (e.g., eliminating standing water,104 ground-level insecticide and larvicide spraying, and aerial spraying) have105 97. carmen l. masson et al., organizational issues in the implementation of a hospitalbased syringe exchange program, 45 substance use misuse 901 (2010). 98. david vlahov & benjamin junge, the role of needle exchange programs in hiv prevention, 113 pub. health rep. 75, 76 (1998). 99. austin coleman, needle exchange programs, the council of state gov’t (june 25, 2015), ht tp: / /knowledgecen ter .csg.org/kc/con tent/needle-exchange-programs [https://perma.cc/6nxs-gl7v]. 100. james g. hodge jr., public health law in a nutshell 260 (west academic, 2nd ed. 2016). 101. h.r. 2029, 114th cong. § 520 (2015). 102. dep't of health & hospital serv. implementation, implementation guidance to support certain components of syringe services programs (2016). 103. olivia becker, bad policy: trump has no plans for tackling hiv/aids – and his team has an abysmal track record, vice news, (dec. 1, 2016), https://news.vice.com/story/trump-hasno-policy-plans-for-hivaids-and-his-team-has-an-abysmal-track-record [https://perma.cc/7zl83wz4]. however, in 2015 then-indiana governor mike pence was asked by local, state, and federal health officials to allow seps (illegal under state law) in response to an hiv epidemic. megan twohey, mike pence’s response to h.i.v. outbreak: prayer, then a change of heart, n.y. times (aug. 7, 2016), https://www.nytimes.com/2016/08/08/us/politics/mike-pence-needle-exchangesindiana.html [https://perma.cc/b9qt-sakt]. it took two months for governor pence to declare a phe and allow a temporary sep, by which point there were nearly ninety emergent cases. governor pence declares public health emergency in response to hiv epidemic in scott county, in.gov (mar. 26, 2015), http://www.in.gov/activecalendar/eventlist.aspx?view=eventdetails& eventidn=214652&information_id=212487&type=&syndicate=syndicate [https://perma.cc/jr8sgbzc]. 104. lorenz von seidlein, alexander s. kekule, & daniel stickman, novel vector control approaches: the future for prevention of zika virus transmission?, 14(1) plos med (2017). 105. anna likos et al., local mosquito-borne transmission of zika virus – miami-dade and broward counties, florida, june-august 2016, cdc morbidity & mortality weekly report https://doi.org/10.3109/10826080903080631 https://doi.org/10.1371/journal.pmed.1002219 42 indiana health law review [vol. 15:23 proven more effective, but public health officials and scientists have sought additional technological methods as well. in august 2016, fda approved a plan to release a limited number of sterile, genetically-modified mosquitos in the florida keys to combat zika through active breeding. although still under106 study, these tactics have demonstrated early success in reducing the presence of aedes aeqypti and emerging cases of zika. public health officials are considering use of this and other advanced technologies more generally to control mosquitos that transmit other diseases like dengue fever and chikungunya.107 vii. conclusion public health legal preparedness laws and policies have undergone massive transformations since september 11, 2001. with these changes have come beneficial improvements in preparedness nationally and regionally, clarifications of policies related to liability protections, and improvements in the delivery of routine public health and health care services. on the horizon, however, are looming uncertainties over the criteria that constitute a phe as well as the level of government primarily responsible for emergency responses on a large or small scale. federal incursions over the past decade especially into traditional statebased public health powers are understandable against a political and practical backdrop focused on a need to control emerging public health threats in a mobilized society. whether the u.s. public health system as currently constructed features sufficient flexibility constitutionally and politically to adapt to continued shifts in the locus of emergency powers is yet to be seen. (mmwr), (sept. 30, 2016), https://www.cdc.gov/mmwr/volumes/65/wr/mm6538e1.htm [https://perma.cc/9zwb-lwur]. 106. fda releases final environmental assessment for genetically engineered mosquito, food & drug admin. (aug. 5, 2016), https://www.fda.gov/animalveterinary/ newsevents/cvmupdates/ucm490246.htm [https://perma.cc/9qtf-4w7u]. 107. nadia l. oussyef et. al., zika virus – 10 public health achievements in 2016 and future priorities, cdc morbidity & mortality weekly report (mmwr) (jan. 6, 2017), https://www.cdc.gov/mmwr/volumes/65/wr/mm6552e1.htm [https://perma.cc/7kq4-cxdz]. what motivates legislators to act: problem definition & the opioid epidemic, a case study taleed el-sabawi* i. introduction despite the partisan1 gridlock2 that has been characteristic of federal congressional behavior in recent years, legislators from both major parties have worked together to draft and enact legislation to address the nation’s current drug problem, commonly referred to as the opioid epidemic.3 even with the partisan tendency for gridlock, such cooperation and action by congress may not come as a surprise, especially given the record-setting number of drug overdose deaths.4 * doctoral candidate, graduate teaching associate, graduate research associate, the ohio state university, college of public health, division of health services management and policy. thank you to micah berman, tom wickizer, the 2016 midwest political science association, and the 2016 american society of law, medicine, and ethics’ health law professors conference for helpful comments and suggestions. special thanks to sandra tanenbaum and her unwillingness to accept “facts” at face value, her inquisitive mind and her tenaciousness. the time and effort she invested in her multiple critiques not only transformed the article, but also changed the way that i viewed some of the issues that i study and write about. sincerest thank you. 1. see parties overview: congress at a glance, voteview.com, https://voteview.com/ parties/all [https://perma.cc/jm2s-96vx] (last visited sept. 2, 2017) (taking poole & rosenthal’s, infra, measures of ideology for each legislator and creating an ideology score for the parties and plotting them by year). keith t. poole and howard rosenthal developed a measure of ideology for each legislator based on her voting record in past roll call votes. see generally keith t. poole, spatial models of parliamentary voting (cambridge u. press 2005). the measure, called dw-nominate (dynamic weighted nominal three-step estimation), is widely used as a measure of how liberal or conservative a legislator is based on her voting behavior. see nolan mccarty, measuring legislative preferences, in the oxford handbook of the american congress (eric schickler & frances e. lee eds., 2011). the dw-nomate data is also used to measure the growing polarization of the american congress. see keith t. poole & howard rosenthal, the polarization of american politics, 46 j. pol. 1061-79 (1984). see also nolan mccarty, keith t. poole & howard rosenthal, polarized america: the dance of ideology and unequal riches (2006). 2. the congressional gridlock has led to congress being referred to as largely unproductive. see drew desilver, congress still on track to be among least productive in recent history, pew res. ctr. (sept. 23, 2014), http://www.pewresearch.org/fact-tank/2014/09/23/congress-still-ontrack-to-be-among-least-productive-in-recent-history/ [https://perma.cc/a47e-plv3]. 3. see, e.g., 42 u.s.c. § 201 (2012); 21st century cures act, pub. l. no. 114-255, 130 stat. 1033 (2016). 4. see nadia kounang, us drug overdose deaths reach new record high, cnn, http://www.cnn.com/2017/08/08/health/drug-overdose-rates-2016-study/index.html [https://perma.cc/38pk-g&s2] (last updated aug. 8, 2017). see also opioid overdose: understanding the epidemic, ctrs. for disease control & prevention, https://www.cdc.gov/ http://doi.org/10.18060/3911.0047 190 indiana health law review [vol. 15:189 however, congress did not just enact legislation to address problem drug use. it enacted legislation that embodied a more health-oriented approach than decades of past legislation. and, it adopted such an approach almost unanimously.5 moreover, many legislators defined problem drug use using terminology that attributed the cause of the problem to medical or biological origins—creating opportunities for the adoption of solutions that call for the involvement of health actors.6 defining a social problem, like problem drug use, involves attributing the cause of the problem to a source7 and often results in assigning responsibility or blame for the problem.8 the problem definition is significant in that it shapes “the perception of policy trade-offs”9 and limits the policy alternatives available to a class of solutions that addresses the problem, as it was defined.10 in the case of problem drug use, congress has seemingly redefined addiction as being caused by a disease11 or over-prescription as opposed to being caused by the drug user’s poor moral character. such a re-definition align with the provisions in the comprehensive addiction and recovery act (“cara”)12—legislation comprised drugoverdose/epidemic/index.html [https://perma.cc/dn3l-3lkl] (last updated aug. 30, 2017) [hereinafter cdc]. 5. cara passed with a 94-1 vote in the senate and a 400-5 vote in the house. see s. rep. no. 1404-1416 (2016); h.r. rep. no. 2355-2368 (2016). 6. i use “solutions” here in the constructivist sense, not to imply that there is a correct or proper solution for a problem but rather that there are multiple policies proposed with the intent of solving a policy problem. i concede that oftentimes the policy proposals that are proposed or enacted typically do not offer a complete solution. however, the proposer’s intent was to solve at least part of the policy problem. 7. the politics of problem definition: shaping the policy agenda (david a. rochefort & roger w. cobb eds., 1994) [hereinafter rochefort & cobb]. 8. deborah a. stone, policy paradox: the art of political decision making(3rd ed. 2012). 9. isaac william martin, redistributing toward the rich: strategic policy crafting in the campaign to repeal the sixteenth amendment, 1938-1958, 116 am. j. soc. 1, 6 (2010). 10. stone, supra note 8. 11. some legislators in congress have also blamed other parties aside from the drug user, like physicians for overprescribing pain medication and pharmaceutical companies for downplaying the addictive properties of opioid prescriptions. see, e.g., harriet ryan & noam n. levey, lawmaker calls for scrutiny of drug makers’ role amid opioid abuse epidemic, l.a. times (may 12, 2016), http://www.latimes.com/local/california/la-me-oxycontin-react-20160513-story.html [https://perma.cc/rdy4-8ytw]. see also susan brooks, house acts to address heroin and opioid abuse crisis (july 8, 2016, 8:30 pm), https://susanwbrooks.house.gov/media-center/pressreleases/house-acts-to-address-heroin-and-opioid-abuse-crisis [https://perma.cc/mmc2-4d97]. 12. comprehensive addiction and recovery act of 2016, pub. l. no. 114-198, 130 stat. 695 (2016). cara includes the provision of funding to expand treatment access to persons suffering from addiction, calls for increased access to overdose reversal medication, encourages states to establish prescription drug monitoring programs (pdmps), and instructs federal agencies to develop education campaigns to help prevent overdoses and addiction, among other provisions. id. such 2018] what motivates legislators to act 191 mostly of health-oriented solutions used to address problems of disease.13 such problem redefinition, or substitution by the dominant problem definition with another,14 is rare, even without the complications of sharp ideological divisions. further, the institutionalization of policy solutions favors the status quo.15 as time passes, the dominant policy solution becomes embedded in legislation, regulations and agency guidelines, making it more resistant to change.16 the institutionalization of policy solutions can also result in the creation of organizations or agencies charged with implementation and enforcement—creating another set of actors that may be invested in maintaining the status quo.17 since the united states (“u.s.”)’s criminal justice orientated problem definition of problem drug use has been dominant for almost a century, with few exceptions,18 a legislative redefinition of problem drug use as a health issue necessitating health-oriented solutions can be viewed as a noteworthy change in legislative orientation. aside from the theoretical implications of this problem redefinition, such a change has normative implications—including the desolutions can be considered “health-oriented” in that they invoke public health or medical solutions that are used to address disease epidemics. i use the term “health-oriented” because although cara may not embrace a true public health approach, it samples some of the solutions typical of a public health and medical approach and defers to health actors, as opposed to criminal justice actors, for much of its implementation and enforcement. 13. more specifically, population health and disease management solutions align with solutions for chronic diseases—the type of disease that addiction is now often categorized as. see, e.g., jane murray cramm & anna petra nieboer, is “disease management” the answer to our problems? no! population health management and (disease) prevention require “management of overall well-being”, 16 bmc health servs. res. 500 (2016). 14. frank r. baumgartner et al., lobbying and policy change: who wins, who loses, and why (u. chicago press 2009). 15. baumgartner et al.’s analysis of ninety-eight policy issues over four years demonstrated only one instance of problem redefinition. id. see also anne larason schneider & helen ingram, policy design for democracy (1997). 16. see baumgartner et al., supra note 14. baumgartner et al. conducted more than 300 interviews with policy-makers and organizations on a random sample of 98 policy issues for two congressional sessions. id. their dataset included these interviews and publicly available information with which they created measures of monetary and non-monetary resources that may advantage some interest groups over others in influencing different phases of the policy process. in their analysis of these interviews, the authors also analyzed problem redefinition. id. 17. id. 18. see david t. courtwright, dark paradise: opiate addiction in america before 1940 (2d 2001) [hereinafter courtwright, dark paradise]; david t. courtwright, forces of habit: drugs and the making of the modern world (2001) [hereinafter courtwright, forces of habit]; david f. musto, the american disease: origins of narcotic control (3d ed. 1999); federal drug control: the evolution of policy and practice (jonathon erlen & joseph f. spillane eds., 2004) [hereinafter erlen & spillane]. 192 indiana health law review [vol. 15:189 stigmatization of problem drug use19 and the substitution of more empirically and comparatively supported health solutions20 for the ineffective criminal justice solutions utilized in the past.21 given that the u.s. has preferred a criminal justice approach to addressing problem drug use for almost a century, legislators’ decision to adopt a healthoriented approach to address this drug crisis is significant. some may argue that congress’ health-orientated approach was simply a result of shifting demographics,22 institutionalized racism,23 or because the current drug crisis was objectively caused by different factors than past drug problems.24 although these theories have merit, they do not explicitly acknowledge the politics of problem definition and its role in the legislative decision-making process. too often, in both legislative and legal scholarship, the role that problem definition plays in the legislative process is ignored, downplayed, or simply forgotten. aside from omitting considerations of problem definition, such theories do not explain how changes in demographics of the drug user population translated to enacted 19. the criminalization of possession of illicit substances in the u.s. has stigmatized problem drug use and created a criminal subculture associated with drug use. see edwin m. schur, crimes without victims: deviant behavior and public policy: abortion, homosexuality, drug addiction (1965). 20. see tamyko ysa et al., governance of addictions: european public policies (2014) (providing a review of such solutions). 21. criminal justice, punitive solutions, or supply side solutions have not only been deemed ineffective by foreign governments, former u.s. president barack obama and former drug czar michael botticelli. see bernd debusmann, obama and the failed war on drugs, reuters (apr. 16, 2012, 1:55 pm), http://www.reuters.com/article/us-column-debusmann-drugs/obama-and-thefailed-war-on-drugs-bernd-debusmann-idusbre83f0zr20120416 [https://perma.cc/4ycpcaap]. 22. while drug epidemics of the 1980s and 1990s primarily affected african americans, the current opioid epidemic has purportedly affected white americans at greater rates than minority populations. recent data, however, suggests that the overdose rates of racial and ethnic minorities are increasing and approaching those of whites. meredith s. shiels et al., trends in u.s. drug overdose deaths in non-hispanic black, hispanic, and non-hispanic white persons, 2000–2015, 168 annals internal med. 453 (2018). 23. institutionalized racism refers to racism that is imbedded in political or societal institutions. see michelle alexander, new jim crow: mass incarceration in the age of colorblindness (2010). historically, in the u.s., punitive solutions have been pursued to address problem drug use most often when the drug users come from marginalized populations, including racial minorities. see courtwright, dark paradise, supra note 18. see also taleed el-sabawi, defining the opioid epidemic: congress, pressure groups and problem definition, u. memphis l. j. 2018. 24. in the past, government agencies may have defined the nation’s drug problem as being characterized by street drug use, in describing the current epidemic, federal agencies have focused more so on attributing the cause to over-prescription. see america’s addiction to opioids: heroin and prescription drug abuse: hearing before the s. caucus on int’l narcotics control, 113th cong. (2014) (statement of nora d. volkow, director, national institute on drug abuse). 2018] what motivates legislators to act 193 legislation that changed the path of u.s. drug policy. although this may be the u.s.’s largest overdose epidemic involving primarily white americans, this is neither the u.s.’s first overdose epidemic affecting whites, nor is it the first drug epidemic that has been blamed on prescribers and drug manufacturers.25 these explanations may be true, but are at best an incomplete list of factors that might have contributed to legislators’26 decisions to adopt a health-oriented approach. this article explores why legislators approached problem drug use as a health problem as opposed to a criminal justice problem when deciding how to address the nation’s opioid epidemic. this article analyzes theories of legislative behavior in an effort to identify the factors that influence legislators to redefine a social problem, in general, and problem drug use in particular. in doing so, this article proposes that the factors that most likely influenced legislators’ decision to adopt a health-oriented approach to this opioid epidemic include: local needs, voter preferences, and interest group and administrative preferences (collectively, “pressure group preferences”). part ii of this article provides an overview of the problem redefinition that was evidenced by cara and discusses its significance. part iii analyzes theories of legislative behavior and ends with a legislative decision-making framework tailored to the political climate and issues surrounding the opioid epidemic. part iv analyzes each factor identified in the proposed framework in depth and provides evidence of each factor’s influence on the redefinition of problem drug use as health issue. lastly, part v summarizes the proposed framework, suggests additional avenues for research, and briefly discusses the practical utility of the proposed framework. ii. cara and the redefinition of problem drug use due to a historically high number of opioid overdose deaths and the quadrupling of opioid overdoses since 1998, both the centers for disease control (“cdc”) and department of health and human services (“hhs”) have declared that we are amidst an opioid overdose epidemic.27 in response to this opioid 25. see courtwright, dark paradise, supra note 18; musto, supra note 18. for an in depth comparison of the current opioid epidemic to past drug epidemics in u.s. history and a justification for such a comparison, please see el-sabawi, supra note 23. 26. when i refer to legislators in this paper, i am referring to federal legislators who were in office during the proposal and passage of cara. 27. according to data compiled from the cdc, more people died of drug overdoses in 2015 than any other year before it. see cdc, supra note 4. approximately 60% of these overdoses involved an opioid. see rose a. rudd et al., increases in drug and opioid-involved overdose deaths—united states, 2010–2015, 65 morbidity & mortality wkly. rep. 1445, 1445-52 (2016). approximately half of the opioid overdoses were attributed to prescription opioids. see cdc, supra note 4; see also the opioid epidemic: by the numbers, u.s. dep’t of health & human servs ., https://www.hhs.gov/sites/default/files/factsheet-opioids-061516.pdf [https://perma.cc/92wn-uth7] (last updated june 2016). 194 indiana health law review [vol. 15:189 overdose death epidemic,28 (hereinafter referred to as “opioid epidemic”) congress, on july 13, 2016, passed cara. the current opioid epidemic is not the first that congress has faced.29 however, cara is arguably the first comprehensive legislative response to problem drug use that promotes health solutions30 over criminal justice solutions. for the greater part of a century, legislators in the u.s. congress have predominately adopted policy solutions that deferred to the criminal justice system to solve the nation’s drug problem. such criminal justice solutions involved the use of criminal sanctions to punish the drug user, to deter his bad behavior, and to punish the supplier, including the drug’s country of origin.31 incarcerating drug users was justified as one of the only proven methods to keep the drug user from harming himself and to protect society from the drug users’ dangerous behavior.32 congressional representatives competed to demonstrate to voters who was the “toughest” on drugs, by supporting the use of tougher criminal sanctions against those who sold or possessed illicit substances.33 congressional support for such solutions was steadfast, despite convincing empirical and comparative evidence that had existed since at least the 1960s,34 demonstrating that utilization of a health approach, an approach that emphasizes 28. it is important to note that congress was specifically responding to an overdose death epidemic and not a rise in addiction rates. federal government agencies, like health and human services and the centers for disease control, have defined the current problem as an overdose epidemic and in their definition of the problem, do not refer to the problem as an addiction epidemic. see cdc, supra note 4. 29. see courtwright, dark paradise, supra note 18; musto, supra note 18. 30. see generally deborah a. stone, policy paradox and political reason (1988) (providing an overview of how policy solutions are crafted in the policy-making process to address social problems). both health solutions and criminal justice solutions are defined infra. 31. see musto, supra note 18; erlen & spillane, supra note 18. 32. see courtwright, dark paradise, supra note 18. 33. id. 34. for example, in 1958, the american bar association (aba) and the american medical association (ama) teamed up to author a special report urging the federal government to reverse its previous hard line anti-harm reduction and anti-maintenance approaches to addressing problem drug use. although the report was based on empirical evidence, it was dismissed as fiction by administrative agency officials and congress determined to continue with the criminal justice approach. the ama and aba finally found supporters in the kennedy administration’s advisory commission on narcotic and drug abuse, which also recommended the investment in methadone maintenance treatment and a greater emphasis on treatment as the solution for problem drug use. see edward m. brecher & the editors of consumer reports, licit and illicit drugs: the consumers union report on narcotics, stimulants, depressants, inhalants, hallucinogens, and marijuana—including caffeine, nicotine, and alcohol (1972). however, the focus on a health approach was brief. when president nixon took office, he declared a war on drugs and emphasized the executive’s commitment to a criminal justice and supply side emphasis. in his rhetoric, president nixon associated drugs with crime and targeted young black males as the leading culprits. see courtwright, dark paradise, supra note 18. 2018] what motivates legislators to act 195 medical and public health methods for both treating and preventing problem drug use, would have been more effective at addressing problem drug use.35 despite the empirical evidence, criminal justice solutions were supported by actors who depicted the drug user or populations at risk for drug use as persons of weak character, who could not help but give in to the seduction of a high, no matter the cost.36 historically, the dominant37 problem definition38 in drug policy has been that the drug user’s poor moral character and his inability to refrain from engaging in hedonistic behavior caused his drug use.39 this causal story40 limited the policy alternatives to legislative solutions that included punishment and supply reduction—solutions aimed at punishing the drug user’s bad behavior and keeping drugs away from him to decrease the likelihood of his use. any healthoriented solutions, which may have included prevention, treatment and medical management of the user (“health solutions”), were treated as secondary solutions, at best.41 the dominant causal narrative argued that to rid the user of the bad behavior, he must be punished and rehabilitated, not offered treatment. punishment was the proper solution for the deviant, while treatment was a solution reserved for the ill.42 in sum, since the early 1900s,43 federal law had largely characterized drug users as “undesirable and criminal”44 and unworthy of public assistance. legislators’ adherence to this causal theory of deviance, and the criminal justice solutions that accompanied such a narrative, was steadfast, despite scientific evidence that demonstrated that factors outside of the drug user contributed to his addiction. this is not to say that there were not any efforts to address problem drug use with more health-oriented solutions. some legislation addressed treatment and 35. see courtwright, dark paradise, supra note 18; ysa et al., supra note 20. 36. merrill singer & j. bryan page, the social value of drug addicts: the uses of the useless (2014). 37. individuals and groups compete to define problems in the policy arena. as such, there are often multiple problem definitions for a single policy issue. the dominant problem definition is the problem definition that is accepted by the majority of actors as the explanation for the cause or source of the issue. see rochefort & cobb, supra note 7. 38. throughout this proposal, i will use “problem definition” to represent both what is referred to by rochefort and cobb and stone as defining a problem and to represent what other scholars refer to as “issue framing” or “issue definition.” rochefort & cobb, supra note 7; stone, supra note 8. see, e.g., baumgartner et al., supra note 14 (referring to it as “issue definition”). 39. see courtwright, dark paradise, supra note 18; courtwright, forces of habit, supra note 18; musto, supra note 18. see also schur, supra note 19. 40. the elements of causal stories and the strategic manner in which they are used in policymaking are outlined in part iii infra. 41. courtwright, dark paradise, supra note 18; musto, supra note 18. 42. courtwright, dark paradise, supra note 18. 43. in 1914, congress passed the harrison tax act. harrison narcotics tax act, ch. 1, 38 stat. 785 (1914) (superseded by the controlled substances act, pub. l. 91-513, 84 stat. 1242 (1970) (codified as amended in scattered sections of 21 u.s.c. (2012)). 44. singer & page, supra note 36, at 168. 196 indiana health law review [vol. 15:189 prevention. however, it was in conjunction to and overshadowed by proposals for criminal justice-oriented solutions, as was the allocation for funding to implement and enforce criminal justice proposals.45 cara was passed in 2016 despite this criminal justice oriented policy history. cara was a bi-partisan bill that passed with an overwhelming majority in both the house and the senate46 during a time of tremendous division between the republicans and democrats. it radically diverges from the u.s.’s historic criminal justice legislative approach47 because of its utilization of health-oriented solutions over criminal justice solutions. for example, cara increases federal funding to the states for treatment of drug addiction and overdoses. cara increases access to medication assisted treatment providers and requires federal and state agencies to disseminate more information to consumers about the risks of prescription opioid abuse, among other provisions.48 cara even focused attention on the potential consequences of the u.s.’s previous legislative commitment to a criminal justice approach 49 by requiring the u.s. government and accountability office 45. notably, even prior to cara, legislators often opined that the proper solution for classes of addicts that were addicted iatrogenically, or by medical error, was treatment, preferably in a private facility. courtwright, dark paradise, supra note 18. after the early 1900s, the number of iatrogenic addicts dwindled as did the popularity of treatment as a solution. courtwright, dark paradise, supra note 18. the preference for criminal justice solutions over treatment solutions is evidenced by the discrepancy between funding allocations to criminal justice enforcement vs. treatment and other health oriented responses. see gonzenbach, infra note 83. 46. see s. rep. no. 1404-1416 (2016). 47. when i refer to a criminal justice approach here and throughout this paper, i am referring to a category of proposed solutions that involve the use of criminal sanctions to deter behavior and result in processing the accused individual in the criminal justice system. the frame of criminal justice is used to define the social problem and often leads to the use of punitive problem solutions. regarding explicit vs. implicit criminal justice approaches, i use the word “explicit” to signify a total criminal justice solution, as opposed to a hybrid solution. for example, cara encourages states to develop prescription monitoring programs, a policy solution that can be considered a health solution, in so far as it is used to identify patients that need addiction treatment, and a criminal justice solution, in so far as it is used to provide law enforcement with information on the prescribing practices of physicians that they may prosecute criminally. cara also includes provisions that expand access of medication-assisted treatment to incarcerated substance abusers, applying a health solution within the criminal justice system. 48. comprehensive addiction and recovery act of 2016, pub. l. no. 114-198, 130 stat. 695 (2016). 49. almost all major federal drug legislation has emphasized a criminal justice approach to dealing with problem drug use. see marihuana tax act of 1937, ch. 553, 50 stat. 551 (1937) (repealed 1970); boggs act of 1951, pub. l. no. 82-255, 65 stat. 767 (repealed 1970); narcotics control act of 1956, pub. l. no. 84-728, 70 stat. 567 (repealed 1970); comprehensive drug abuse prevention and control act (cdapca) of 1970, pub. l. no. 91-513, 84 stat. 1236 (codified as amended in scattered sections of 18 u.s.c., 19 u.s.c., 21 u.s.c., 26 u.s.c., 28 u.s.c., 31 u.s.c., 40 u.s.c., 42 u.s.c.); racketeer-influenced and corrupt organizations act (rico), pub. l. no. 2018] what motivates legislators to act 197 (“gao”) to prepare a report on the “collateral consequences”50 of criminalization for individuals who were convicted of non-violent drug possession.51 legislators not only adopted health-oriented solutions when enacting cara, but also redefined the problem of drug use as a health issue. legislators who authored the bill redefined problem drug use as a health problem, caused by a disease or disorder of the body and mind—a problem definition that clearly differs from past criminal justice problem definitions of deviance and poor moral character.52 as republican senator robert portman, who authored the senate version of the cara, noted: this is a historic moment, the first time in decades that congress has passed comprehensive addiction legislation, and the first time congress has ever supported long-term addiction recovery. this is also the first 91-452, tit. ix, 84 stat. 922, 941-48 (1970) (codified as amended in scattered sections of 18 u.s.c. §§ 1961-1968); continuing criminal enterprise (cce) statute, 21 u.s.c. § 848 (2012); posse comitatus act amendments of 1981, pub. l. no. 97-86, § 905, 95 stat 1099, 1114-16; comprehensive crime control act of 1984, pub. l. no. 98-473, 98 stat. 1837 (codified in scattered sections of 18, 31 u.s.c.); anti-drug abuse act of 1986, pub. l. no. 99-570, 100 stat. 3207; antidrug abuse amendments act of 1988, pub. l. no. 100-690, 102 stat. 4312; and crime control act of 1990, pub. l. no. 101-647, 104 stat. 4789 (codified as amended in scattered sections of 18 u.s.c.). there were a few departures from purely criminal justice oriented legislative. arguably, the drug abuse control amendments of 1965 and the narcotic addict rehabilitation act of 1966 were less criminal justice and more “medical treatment” focused. see courtwright, dark paradise, supra note 18, at 163; drug abuse control amendments of 1965, pub. l. no. 89-74, 79 stat. 226 (1965); narcotic addict rehabilitation act of 1966, pub. l. no. 89-793, 80 stat. 1438 (1966). but both pieces of legislation were replaced two years later by nixon’s cdapca, so they did not have a lasting effect. the drug abuse office and treatment act of 1972, which resulted in the creation of nida, and the 1974 legislation that created the alcohol, drug abuse, and mental health administration (“adamha”), which later became samhsa, were not criminal justice oriented either, but only resulted in the creation of agencies within the administration. see drug abuse office and treatment act of 1972, pub. l. no. 92-255, 86 stat. 65 (codified as amendment 21 u.s.c. §§ 1101-81); adahma reorganization act of 1992, pub. l. no. 102-321, 106 stat. 323 (codified as amended in scattered sections of 42 u.s.c.). moreover, the 2007 second chance act focused on increasing treatment options and rehabilitation options to those who had been convicted and completed their sentence. see 2007 second chance act, pub. l. no. 110-199, 122 stat. 657 (2008) (codified as amended in scattered sections of 42 u.s.c.). although this footnote does not provide an exhaustive list of legislation, it provides the reader with an overview of the legislation that is most typical of u.s. drug policy. 50. according to title iv, sec. 401 of cara, collateral consequences are penalties or disadvantages imposed on such individuals by law, an administrative agency, or a court, not including consequences imposed at sentencing. see comprehensive addiction and recovery act of 2016 § 401(b). 51. comprehensive addiction and recovery act § 401. 52. courtwright, dark paradise, supra note 18; musto, supra note 18. 198 indiana health law review [vol. 15:189 time that we’ve treated addiction like the disease that it is, which will help put an end to the stigma that has surrounded addiction for too long.53 cara was soon funded by the 21st century cures act with an unprecedented one billion dollars, perhaps demonstrating a more serious commitment to a healthoriented approach to problem drug use. this problem redefinition by congress leads one to ask: why such a change and why now? further, what motivated legislators to act to change drug policy given their inaction in other policy areas? iii. what motivates legislators’ behavior? a. a legislator’s goals: general theory although most scholars would agree that legislative behavior is motivated by a variety of factors, they disagree as to which of these factors is most influential. i briefly outline a few competing theories, including those that emphasize party preferences, cues from other legislators and even legislators’ own personal preferences as central motivators. i then summarize more comprehensive models of legislative decision-making, including kingdon’s consensus model—the model upon which i base my framework. i analyze each theory, ascertaining its strengths, weaknesses, and utility in explaining legislative behavior as applied to the opioid epidemic. the summary below is by no means exhaustive, but offers a short review of the theory on legislative decision-making and provides the foundation needed to justify the legislative decision-making framework that i propose for analyzing the opioid epidemic at the end of part iii. 1. the party some scholars, like cox and mccubbins, argue that legislators consider their party preferences before casting a vote.54 they argue that parties act as cartels influencing legislators to vote in the best interest of the party, even if it means voting in opposition to district preferences.55 other scholars disagree, arguing that party is just a label for legislators that already have similar preferences and that legislators are just voting their preferences.56 aldrich and rohde take the middle road and argue for conditional party government, articulating the conditions 53. press release, rob portman, portman, whitehouse, ayotte, klobuchar cheer final passage of comprehensive addiction and recovery act (july 13, 2016). 54. see gary w. cox & mathew daniel mccubbins, legislative leviathan: party government in the house (cambridge u. press, 2nd ed. 2007). see also gary w. cox & mathew daniel mccubbins, setting the agenda: responsible party government in the u.s. house of representatives (2005). see also tim groseclose & james m. snyder, interpreting the coefficient of party influence: comment on krehbiel, 11 pol. analysis, winter 2003, at 104-07. 55. some scholars argue that political parties also influence legislative behavior. however, once controlling for ideology and voting records, evidence for an independent party effect is weak. see keith krehbiel, where’s the party?, 23 brit. j. pol. sci. 235, 235-66 (1993). 56. id. 2018] what motivates legislators to act 199 necessary for the party to influence legislators independently.57 in sum, the literature is undecided as to the degree to which, if at all, party affiliation affects legislator votes. however, the straight party line votes that have been the hallmark of health policy for the last eight years provide some anecdotal evidence that in at least some circumstances parties can influence a legislator’s voting behavior.58 since members of both parties drafted and voted for the adoption of cara’s health-oriented approach, at the surface, party membership does not seem to explain legislator behavior, at least in this instance of drug policymaking. 2. cue-taking matthews and stimson, among others, argue that legislators take cues from one another as to how to vote on an issue in order to cut the information costs associated with making a decision on how to vote.59 similarly, truman finds that legislators often form blocs with other legislators who have common interests, and they consult with these blocs on issues prior to votes.60 even if such cuetaking is influential, it seems most influential on issues that legislators’ constituents do not have intense preferences.61 since constituents typically have opinions and preferences on drug policy issues, cue-taking would likely be less influential on the legislators’ decision-making process.62 3. legislator preferences other scholars argue that even if party pressure and cue-taking influence legislative behavior, the factor that is most likely to predict a legislator’s vote on an issue is her own personal ideology.63 such ideology is said to supersede even constituent preferences and re-election considerations.64 to support such claims, scholars point to studies that show that there is low congruence between legislator 57. john h. aldrich & david rohde, the consequences of party organization in the house: the role of the majority and minority parties in conditional party government, in polarized politics: congress and the president in a partisan era (jon r. bond & richard fleisher ed., 2000). 58. see generally john e. mcdonough, inside national health reform (2012). 59. see donald matthews & james stimson, decision-making by u.s. representatives, in political decision-making 14-43 (s. sidney ulmer, ed., 1970). see also donald matthews & james stimson, yeas and nays: normal decision-making in the u.s. house of representatives (1975). 60. david truman, the congressional party (1959). 61. john w. kingdon, models of legislative voting, 39 j. pol. 563-95 (1977). 62. see courtwright, supra note 18, which provides evidence of legislators’ efforts to please their constituency by being tough on drugs. there does not appear to be any systematic analysis of legislative cue-taking on the issue of drug policy. 63. cleo cherryholmes & michael shapiro, representatives and roll calls (1969). keith t. poole, changing minds? not in congress!, 131 pub. choice, 435, 435-51 (2007); keith t. poole & howard rosenthal, patterns of congressional voting, 35 am. j. pol. sci., 228, 228-78 (1991); keith t. poole & howard rosenthal, are legislators ideologues or the agents of constituents?, 40 european econ. rev. 717, 717 (1996) [hereinafter poole & rosenthal 1996]. 64. poole & rosenthal 1996, supra note 63. 200 indiana health law review [vol. 15:189 votes and district preferences.65 the literature on policy congruence proves more often than not that legislators’ votes do not align with the majority of voters’ preferences or the median voter’s preference in their local districts—leading some scholars to question the degree to which legislators consider their constituents’ policy preferences.66 normatively, such behavior can be justified by the “trustee view” of legislative representation, wherein a legislator’s duty is to vote in a manner that she believes is in the best interest of her district, even if such a vote is not reflective of the preferences of her constituents.67 despite the evidence supporting legislator ideology as the primary predictor of a legislator’s behavior, cara’s vote was a “lopsided vote with no ideological division”,68 suggesting that factors aside from ideology influenced legislators’ decisions to adopt a health-oriented approach to addressing the opioid crisis. 4. models of legislative decision-making according to fenno (1973) in his seminal work on congress, congressmen in committees, legislators are motivated by three main goals: re-election, influence within congress, and good public policy. mayhew and other scholars69 argue that the goal of re-election is the most central motivating factor for legislators, for re-election must be achieved before any other goals can be met.70 building on mayhew and fenno’s work, kingdon developed a “consensus model.” to do so, he conducted 200 interviews of legislators and identified actors who legislators considered prior to voting on an issue. he found that these actors were voters, interest groups, administrative agencies, and fellow legislators.71 while considering these actors’ preferences, legislators also reported considering their own preferences72 and voting record. although kingdon’s work on legislative decision-making precedes some of the studies cited above, his consensus framework combines theories of legislative behavior and, surprisingly, 65. jeffrey r. lax & justin h. phillips, the democratic deficit in the states, 56 am. j. pol. sci. 148, 148-66 (2012); john g. matsusaka, popular control of public policy: a quantitative approach, 5 q. j. pol. sci. 133, 133-67 (2010). 66. see part iii for a more in depth discussion of policy congruence. 67. martin j. osborne & al slavinski, a model of political competition with citizencandidates, 111 q. j. pol. sci. 65, 65-96 (1996); timothy besley & stephen coate, an economic model of representative democracy, 112 q. j. pol. sci. 85, 85-114 (1997). 68. for the house vote, see jeffrey b. lewis et al., voteview: congressional roll-call votes database (2017), https://voteview.com/rollcall/rh1141099 [https://perma.cc/cx2z6nzf]. for the senate vote, see jeffrey b. lewis et al., voteview: congressional roll-call votes database (2017), https://voteview.com/rollcall/rs1140373 [https://perma.cc/8y82-9le7]. 69. see also morris p. fiorina, representatives, roll calls, and constituencies (1974). 70. david r. mayhew, congress: the electoral connection (1974). 71. kingdon, supra note 61. 72. id. since a legislator’s ideology is often strongly correlated with the ideology of her constituents, it is difficult to ascertain the independent effect of ideology after controlling for constituent ideology. id. 2018] what motivates legislators to act 201 also addresses factors that were later identified by scholars as influential.73 kingdon’s model demonstrates that legislators’ primary goals are to satisfy constituents, increase or maintain intra-washington influence, and create good public policy.74 elaborating on the factors in his model, kingdon argues that legislators consider constituency preferences, not only when they are up for reelection, but do so throughout their term and anticipate re-election consequences far in advance.75 kingdon’s goal of intra-washington influence expands on fenno’s conceptualization, by including not only fellow members of congress, but party leadership and the administration, thus including “party” as a factor. lastly, kingdon conceptualizes good public policy as a reflection of legislators’ “policy attitudes, their ideology.”76 this definition of good public policy demonstrates that kingdon’s model includes legislative ideology or preferences as factor in a legislator’s decision-making process. kingdon’s model can be differentiated from other models in that he attempts to map out the factors in the order that they are considered by a legislator. according to kingdon’s model, first, a legislator votes with the consensus of her environment. if there is controversy over how she should vote, then she will be most persuaded by voters and interest groups. voters and interest groups are most effective if their opinions are “intense” and the issue is salient.77 kingdon found that this held true regardless of whether an election is near or whether the legislator is in a safe seat. kingdon notes however that a legislator does not necessarily consider all voters and interest groups, but may, for example, consider a narrow subset of her constituents.78 kingdon’s model of legislative decision-making provides a framework with which to explore why legislators redefined problem drug use when enacting cara. the factors from kingdon’s model which seem most relevant are constituents’ and interest groups’ preferences. the issue of opioid misuse and opioid overdoses have been salient in the media. as such, if voters and interest groups demonstrate “intense” and clear support for a health-oriented approach to addressing the opioid epidemic—kingdon’s model would suggest that their preferences will heavily influence legislators’ decisions to support health-oriented proposals. conversely, kingdon’s model would also suggest that, in the past, when congress enacted criminal justice oriented legislation, constituents were either silent or intense in their support for the criminal justice proposals. if voters and groups do not voice especially strong opinions on how to address problem drug use, then the legislators’ considerations would shift to intra-washington 73. for example, kingdon confirmed that legislators consulted their own individual preferences. kingdon, supra note 61. these “preferences” are the predecessors for what scholars, like poole & rosenthal, later quantified as “ideology.” 74. kingdon, supra note 61. 75. id. at 570-71. 76. id. at 571. 77. id. 78. id. 202 indiana health law review [vol. 15:189 actors, including fellow legislators and the administration.79 these possibilities will be explored infra. kingdon’s model also identifies administrative agency preferences as an input in the legislative decision-making process. drug policy historians provide ample evidence that at various points in u.s. history federal administrative officials have influenced the problem definition of drug use, by at times publishing reports that over-estimated the number of addicts in the country in order to make drug use appear more widespread,80 and at other times, publishing statistics that selectively highlighted the apparent success of the criminal justice approach.81 historically, administrative officials have also publicly denounced medication assisted treatment (“mat”) policy solutions and have actively worked to discredit research reports supporting its efficacy.82 legislators have cited such reports and administrative agency official testimony as support for their policy positions on drug issues.83 according to kingdon’s model, however, these administrative agency preferences would have been at the forefront of a legislator’s considerations only when constituents’ preferences were not intense. 5. proposed framework for analyzing legislative decision-making in drug policy the legislative behavior theories discussed above outline certain factors that may influence a legislator’s decision to support a particular problem definition or policy solution. each theory reviewed is supported by evidence; however, in no case is the evidence conclusive. further, each theory may interact with issue specific variables unique to that policy domain. the identified factors may be influenced or restricted by policy history and policy path dependence. its factors may also be affected by specialized institutions that may not be active on all issues. for example, the institutions at both the state and federal level that are affected by drug policy differ from those that are affected by tax reform. as such, the utility of each theory in explaining legislative decision-making will likely differ depending on the type of issue addressed. in sub-sections 1-3, i briefly outlined why it is unlikely that party pressure, cue-taking, and legislator ideology explain legislators’ decisions to adopt a health 79. further, kingdon found that the administration is especially persuasive if the president is of the same party. kingdon, supra note 61. whitford and yates extend this claim arguing that regardless of the party of the president, most u.s. presidents have utilized rhetoric to affect the types of policy proposals adopted to address problem drug use. see andrew b. whitford & jeff yates, presidential rhetoric and the public agenda: constructing the war on drugs (2009). 80. musto, supra note 18; erlen & spillane, supra note 18. 81. such statistics focused on reporting increases in the number of drug related arrests as opposed to statistics highlighting better treatment outcomes for problem drug users. see musto, supra note 18; erlen & spillane, supra note 18. 82. see erlen & spillane, supra note 18; musto, supra note 18. 83. courtwright, dark paradise, supra note 18. see also william j. gonzenbach, the media, the president, and public opinion: a longitudinal analysis of the drug issue, 1984-1991 (1996). 2018] what motivates legislators to act 203 approach to address the opioid epidemic. i argued that the insights such theories could provide were limited due to the bipartisan support for a health-oriented approach in 2016. of the theories summarized in this article, kingdon’s consensus model appears to be most useful in identifying factors that may have influenced legislators to adopt a health approach to the opioid epidemic. kingdon’s model provides a useful organizational framework for which to begin our analysis. in the following section, i will build upon kingdon’s framework, tailoring it to address drug policy specific issues. further, i will demonstrate that legislators may have supported the enactment of health-oriented proposals, as embodied by cara, because doing so allowed legislators to both protect their re-election prospects and create good public policy by (1) solving a pressing social problem that affects local voters (“local needs consideration”) using health-oriented policy proposals (2) supported by voters (“voter preferences consideration”), (3) supported by organized interest groups (“interest group preferences consideration”), and (4) that had buy-in from the administrative agencies responsible for enforcement (“administrative preferences consideration”). for each factor, i will begin with a review of the literature that supports the factor’s inclusion in the proposed legislative decision-making framework. i will then follow with evidence of each factor’s relevance as applied to legislative decision-making in relation to drug policy and the opioid epidemic. iv. a legislator’s considerations a. local needs considerations 1. theoretical justification legislators want to solve problems that affect their local districts and that are considered important by their voting constituents. one way legislators can fulfill both of these considerations is to direct federal money to programs that address a salient local issue.84 because the public is often unaware of the new influx of federal money into the district, the legislator would then put out messages to constituents claiming credit for the allocation of federal money aimed at solving the local problem.85 these credit-claiming messages would directly cultivate support for the incumbent,86 thereby increasing the likelihood for re-election. theoretically, a legislator would be rewarded most for addressing a local problem that (1) affects the greatest number of her voting constituents and in doing so, (2) considers their policy preferences, or opinions on which policy solution should be adopted to address the problem. since legislative resources are limited, it is in a legislator’s best electoral 84. bruce cain, john ferejohn & morris fiorina, the personal vote: constituency service and electoral independence (1987). 85. justin grimmer, solomon messing & sean westwood, how words and money cultivate a personal vote: the effect of legislator credit claiming on constituent credit allocation, 106 am. pol. sci. rev. 703-19 (2012). 86. id. 204 indiana health law review [vol. 15:189 interest to focus her attention on addressing the policy problems that affect the greatest number of constituents. the more constituents the problem affects, the greater the electoral payoff, because the enacted policy solution would inevitably affect more voters. moreover, if re-election is indeed an important consideration for legislators, then solving a problem that affects populations that have high voter turnout would provide the most re-election benefits for the legislator. solving a problem that affects wealthy donors would also be a strategic use of a legislators’ time, as doing so may attract additional campaign contributions. not only would legislators be most incentivized to focus on problems that affect the greatest number of constituents, likely voters and wealthy donors, but they would also be incentivized to consider the policy preferences of these groups when choosing the type of policy solution to endorse. although such logic is sound, the literature is divided on whether or not legislators pay more attention to the issues and opinions of demographic groups that are more likely to turn out to vote.87 demographics that have been associated with voter turnout include race, income and education, with whites that are higher income earners reporting the highest voter turnout rate (“upper class whites”).88 although whites only represent 65% of the u.s. population, they represented 75% of the voters in the 2014 election,89 suggesting that they have a higher voter turnout rate than minority groups. similarly, individuals in the middleto high-income brackets are more likely to vote than those in lower income brackets. individuals coming from families with incomes of less than $30,000 made up only 16% of the voters in the 2014 election, even though they represent 28% of the population.90 if legislators pay attention to the issues affecting voters more than nonvoters, then addressing issues affecting white middle-and upper-class constituents may appear to have a greater re-election payoff and may therefore be prioritized, especially if some of these constituents are generous campaign contributors. 87. see, e.g., james avery, does who votes matter? income bias in voter turnout and economic inequality in the american states from 1980 to 2010, 37 pol. behav. 955-76 (2015). 88. comparing the results of different likely voter models, in pew res. ctr, can likely voter models be improved? evidence from the 2014 u.s. house elections 14-18 (jan. 7, 2016), http://assets.pewresearch.org/wp-content/uploads/sites/12/2016/01/pm_2016-01-07_likelyvoters_final.pdf. 89. id. 90. as of 2014, the age group with the greatest age adjusted rates of overdose deaths are white men and women between the ages of forty-five and fifty-four. see rudd et al., supra note 27. i was unable to locate the age group with the greatest age adjusted rate of overdose deaths in the 1980s and 1990s. persons between the age of fifty and sixty-four are overrepresented at the poll. see pew res. ctr., supra note 88. this suggests that they are considered likely voters whose preferences may be especially important to legislators. 2018] what motivates legislators to act 205 figure 1. the empirical evidence supporting the contention that legislators are influenced most by the preferences of upper-class whites is mixed. some studies show that legislators tend to pay more attention to the opinions of high income and wealthy individuals91 and to non-hispanic whites’ preferences over african americans or latinos, even after controlling for income.92 while other studies find no statistically distinguishable difference between high vs. low income constituents.93 conflicting studies also demonstrate that on issues that are especially salient to minority groups, like crime, education, and healthcare, their preferences are at least as influential as whites.94 although the findings in the literature are inconclusive, the evidence suggests that at times legislators may prioritize the policy preferences of certain races or classes over others. therefore, it is plausible that legislators were willing to adopt a health-oriented approach to the current opioid epidemic if upper-class whites or other likely voters were affected by the opioid epidemic and supported healthoriented solutions. further, it is likely that as the opioid epidemic became more geographically dispersed, more legislators saw the opioid epidemic as a problem 91. fay lomax cook, benjamin page & rachel moskowitz, political participation by wealthy americans, 129 pol. res. q. 381, 381-98 (2014); kay lehman schlozman, sidney verba & henry e. brady, the unheavenly chorus: unequal political voice and the broken promise of american democracy (2012). 92. john d. griffin & brian newman, minority report: evaluating political equality in america (2008). 93. yosef bhatti & robert s. erikson, how poorly are the poor represented in the u.s. senate?, in who gets represented? 223-46 (peter k. enns & christopher wlezien eds., 2011). 94. id. there is some question, however, as to whether such differences are true differences or if they are due to the fact that districts with a majority of minority residents tend to be more ideologically heterogeneous; when such heterogeneity is controlled for, differences in legislator representation of preferences no longer exists. brandice canes-wrone, from mass preferences to policy, 18 ann. rev. pol. sci. 147, 147-65 (2015). 206 indiana health law review [vol. 15:189 affecting a large number of their local constituents and thereby worthy of their time and attention. 2. the opioid epidemic as a local issue as it has progressed, the opioid epidemic has become denser and more geographically dispersed, affecting more local populations and states and doing so at greater degrees (see figure 1).95 from 2009 to 2015, the rate of overdose deaths increased in most states and localities. but not only has the problem gotten worse in the affected areas, but the problem has also spread to more communities, more districts, and more states (see figure 2). 2009. 95. such increased geographic distribution has a number of consequences at the state and federal level. for example, at the state level, as the problem increases in geographic range and density, it reaches magnitudes at which the state cannot afford to address the problem without federal assistance, resulting in state administrations lobbying federal legislators to provide federal funds to assist. such pleas for federal assistance may be made using media outlets and further focuses constituents’ attention on the need for federal legislative action. 2018] what motivates legislators to act 207 2015. figure 2. and as the problem spreads to more legislators’ districts and states, the opioid epidemic has become a “local problem” for a greater number of legislators. as more constituents become affected by problem drug use in the form of addiction and overdose deaths, the calls from voters for legislative action to address the problem are likely to increase. since problem drug use devastates families, networks of friends, co-workers, and members of the helping professions, one overdose death affects a network of voters, thus magnifying the issue in ways the maps in figure 2 cannot begin to capture. the geographic distribution of the problem spans the rural-urban divide and does not distinguish between republican or democratic led states—unlike past drug epidemics that may have been confined to certain urban or metropolitan areas. given that the problem is so geographically widespread, the bipartisan call for a legislative solution becomes less surprising. the opioid epidemic has cut across more than just geographic boundaries. whereas, past drug epidemics may have been confined to poor or otherwise marginalized populations, the current epidemic is not confined to the poor nor is the population comprised of primarily racial or ethnic minorities.96 the current 96. during the crack-cocaine epidemic of the late 1980s, overdose victims were primarily poverty-stricken african americans. see the following graph which i created using cdc data that compares the rates of overdose deaths from 1979-1998 by race: compressed mortality, 1979-1998 charts, ctrs. for disease control & prevention (aug. 13, 2017), https://wonder.cdc.gov/ controller/saved/d16/d19f641 [https://perma.cc/9ypw-h2zk]. 208 indiana health law review [vol. 15:189 population of overdose victims are whiter and more middle-class than previous populations.97 the majority of overdose victims are still primarily members of the lower class,98 yet there has been an increase in the number of overdose deaths in both the middle-99 and upper-class—suggesting that the problem affects a variety of constituents and affects “likely voters.” since the opioid epidemic impacts sub-populations of constituents that have traditionally had high voter turnouts, legislators may be more incentivized to address problem drug use and to do so in a less stigmatizing manner. solutions that emphasize punishment and incarceration—and stigmatize the user—are likely less popular when the population being targeted is a demographically diverse cross-section of a legislator’s constituency. when the affected constituents are calling for legislative aid in addressing the opioid epidemic, they are likely seeking help for themselves or their loved ones—help that is more characteristic of health institutions than criminal justice institutions. such claims are facially convincing but do voter preference measures support the claim that these affected populations prefer health-oriented solutions as opposed to criminal justice solutions? b. voter preferences considerations when ascertaining voter preferences on an issue, legislators likely look to public opinion polls or media framing.100 legislators also report considering “latent public opinion,” or how they believe the public will react if they were to enact certain policies.101 if these claims hold true, then a national shift in public support for health approach versus a criminal justice approach would have encouraged legislative support to shift in a similar direction. however, the relationship between congressional action and public opinion is complex.102 97. admittedly, such changes, especially involving the racial composition of the target population, likely contributed to the near-abandonment of a criminal justice approach for a health approach—due in part to the racism endemic drug policy documented by other scholars. see alexander, supra note 23. 98. because the cdc provides income or education levels for overdose deaths in their publicly facing query system, wonder, it is difficult to discern which income bracket has the greatest number of overdose victims. however, data from the national survey on drug use and health does indicate that persons with an annual income of less than $20,000 has the greatest rate of heroin use (as of 2011-2013, 5.5 per 100,000, compared to 2.3 for $20,000 to $49,999 and 1.6 for $50,000 or more). although all income groups have seen in increase in the rate of heroin use from 2002 to 2013. see vital signs: today’s heroin epidemic, ctrs. for disease control & prevention, https://www.cdc.gov/vitalsigns/heroin/index.html [https://perma.cc/527y-edj8] (last updated july 7, 2015). 99. id. 100. john w. kingdon, agendas, alternatives, and public policies (1984) [hereinafter agendas, alternatives, and public policies]. 101. v.o. key, public opinion and american democracy (1961). 102. robert s. erikson, roll calls, reputations, and representation in the u.s. senate, 15 2018] what motivates legislators to act 209 although qualitative interviews with legislators suggest that legislators consider public opinion when making decisions,103 the quantitative literature on the congruence between public opinion and policy do not demonstrate a high level of correlation between the policies supported by the majority of the population and policies that are enacted by legislators.104 such results, however, may be explained by the limitations of the methodology, differential congruence depending on sub-group, or differences between policy issues.105 much of the literature on policy congruence looks at the global opinion of the american public on a number of policy issues when reporting their findings and do not explore differences in congruence based on policy issue.106 on average, global public opinion may not be congruent with policy, but some studies show that after controlling for partisanship, legislators are responsive to local voter preferences on issues107 and state voter preferences.108 the global average may be masking interesting individual differences. these individual differences may be further evident when looking at specific policy domains, like drug policy, as opposed to looking at a large category of policies, like social welfare policy. further, the legis. stud. q. 623-42 (1990). first, elected officials may share values with the constituents who elected them. second, voters take cues from a legislator’s stance on issues when deciding for whom to vote. third, elected officials may give weight to their district’s preferences prior to voting on a roll call. id. 103. see, e.g., agendas, alternatives, and public policies, supra note 100; see also richard f. fenno, home style: house members in their districts (1978). 104. see, e.g., matsusaka, supra note 65; jeffrey r. lax & justin h. phillips, the democratic deficit in the states, 56 am. j. pol. sci. 148, 153 (2012). these studies found legislative votes to be congruent only 59% and 48% of the time, respectively. 105. canes-wrone, supra note 94. 106. an example of such is matsusaka’s article analyzing congruence of roll-call votes with public opinion. john g. matsusaka, when do legislators follow constituent opinion? evidence from matched roll call and referendum votes 11-12 (stigler ctr. for study econ. and state, working paper no. 9, may 2017), https://research.chicagobooth.edu/~/media/ a048f1608a6b4963a7a201259aef03e9.pdf [https://perma.cc/jtp3-etvu]. matsusaka found that legislators voted their district’s preference only 65% of the time, which is 15% greater than chance. id. further, matsusaka found that policy congruence may depend on type of policy issue. id. for example, when analyzing california’s gambling law, he only found a 27.9% congruence, yet a 92.4% congruence was found when looking at california’s health insurance law – suggesting that policy specific factors may affect congruence. id. 107. larry m. bartels, constituency opinion and congressional policy making: the reagan defense buildup, 85 am. pol. sci. rev. 457 (1991); thomas stratmann, congressional voting over legislative careers: shifting positions and changing constraints, 94 am. pol. sci. rev. 665 (2000). 108. erikson, supra note 102; christopher warshaw, are senators more responsive to public opinion later in the electoral cycle? (columbia university conference on responsiveness, representation and democracy, unpublished manuscript, feb. 25, 2013), https://responsiveness2013.files.wordpress.com/2013/02/warshaw-senators-more-responsive-laterin-cycle.pdf [https://perma.cc/xp5p-e3ky]. 210 indiana health law review [vol. 15:189 literature exploring the effects of shifts in public opinion on legislative decisionmaking provides support for the idea that a shift in public support for a health approach vs. a criminal justice approach may have preceded and influenced the legislative shift evidenced by cara. 1. shifts in public opinion there is strong support for the contention that legislators are responsive to changes in public opinion, also called dynamic representation.109 it is hypothesized that as public opinion changes, legislators sense the change and alter their policy behavior in response, especially in anticipation of an upcoming election.110 since voters replace legislators who are “out of step with public opinion,” legislators may be threatened with an electoral loss if they do not respond to the change in opinion.111 “when politicians perceive public opinion change, they adapt their behavior to please their constituency and, accordingly, enhance their chances of re-election.”112 legislators are most likely to re-characterize an issue when the change in 109. canes-wrone, supra note 94. 110. see, e.g., agendas, alternatives, and public policies, supra note 100; james a. stimson, michael b. mackuen & robert s. erikson, dynamic representation, 89 am. pol. sci. rev. 543 (1995); thomas hartley & bruce russett, public opinion and the common defense: who governs military spending in the united states?, 86 am. pol. sci. rev. 905 (1992); christopher wlezien, dynamics of representation: the case of us spending on defence, 26 brit. j. pol. sci. 81 (1996); mark a. smith, public opinion, elections, and representation within a market economy: does the structural power of business undermine popular sovereignty?, 43 am. j. pol. sci. 842 (1999). 111. canes-wrone, supra note 94, at 149. if a legislator is not aligned with voters’ preferences, then she risks being replaced by another legislator. there is evidence that federal legislators are sanctioned by voters for votes that are not popular with their constituents on issues concerning the budget, congressional salaries, and healthcare. see gary c. jacobson, deficit-cutting politics and congressional elections, 108 pol. sci. q. 375 (1993); john a. clark, congressional salaries and the politics of unpopular votes, 24 am. pol. res. 150 (1996); brendan nyhan et al., one vote out of step? the effects of salient roll call votes in the 2010 election, 40 am. pol. res. 844 (2012). such accountability is more likely under certain political conditions than others. see, e.g., steven ansolabehere, james m. snyder & charles stewart, constituents’ responses to congressional roll-call voting, 46 am. pol. sci. j. 583 (2001). for example, recent research by rodgers finds that legislators are much less likely to be held accountable by voters at the state level. steven rogers, electoral accountability for state legislative roll calls and ideological representation, 111 am. pol. sci. j. 555 (2017). some argue that this is likely a result of less media attention, more uncompetitive political elections, and incumbency advantages at the state level. see, e.g., id.; john m. carey, richard g. niemi & lynda w. powell, term limits in the state legislatures (2000); the marketplace of democracy: electoral competition and american politics (michael p. mcdonald & john samples eds., 2006). however, others like matsusaka, supra note 65, find that electoral pressure has no statistically significant effect. 112. stimson, mackuen & erikson, supra note 110, at 545; see, e.g., hartley & russett, supra note 110; wlezien, supra note 110; smith, supra note 110. 2018] what motivates legislators to act 211 public opinion is a “large[,] stable” change on a salient issue.113 legislators change their behavior on the margin, making the changes they can within their ideological spectrum to match the change in public opinion.114 due to the preference for the status quo built into the legislative system, “more than a moderate level of popular support for a policy reform is generally needed for it to be enacted.”115 further, there are structural conditions that can interfere with the dynamic representation hypothesis, including: (1) partisan bias, (2) manipulation of public opinion, (3) the electoral cycle, (4) issue salience, and (5) policy domain.116 2. shifts in public opinion coinciding with changes in the target population a factor that can impact the manner in which public opinion on an issue shifts is the composition of the target population, or population that the policy solution is thought to benefit or burden. for example, the target population of policies enacted to address the opioid epidemic could include drug users, drug suppliers, family members of drug users, or employers, among others. legislators choose from the list of affected actors when enacting a solution. the demographics and characteristics of a target population can influence both public and legislator perceptions of who or what caused the problem and which legislative proposals are best suited to address the problem, due in part to the social construction of categories of persons that are members of the target population. these categories are defined by rules that determine the terms of inclusion.117 schneider and ingram argue that categories of persons are socially constructed into two main types, those who are deserving of social assistance and those who are undeserving. examples of deserving populations include senior citizens, veterans or active military, children, mothers, the middle-class, farmers and the ill.118 the poor, on the other hand, are constructed as undeserving. due in part to early puritan influences on the development of american values, the poor have been traditionally depicted as lazy and lacking discipline.119 therefore, americans harbor a general distaste for policy benefits that appear to be “handouts,” or “unearned” benefits, to the poor.120 individuals addicted to illicit substances have been traditionally categorized alongside criminals as deviants, undeserving of public assistance.121 past drug epidemics in the u.s. have affected poor and marginalized populations that resided in urban areas already riddled with crime, so even if the label of the drug 113. benjamin i. page & robert y. shapiro, effects of public opinion on policy, 77 am. pol. sci. rev. 175, 181 (1983). 114. stimson, mackuen, & erikson, supra note 110. 115. canes-wrone, supra note 94, at 148. 116. canes-wrone, supra note 94. 117. stone, supra note 8; schneider & ingram, supra note 15. 118. stone, supra note 8; schneider & ingram, supra note 15. 119. see james a. morone, hellfire nation: the politics of sin in american history (yale u. press 2008). 120. see stone, supra note 8. 121. id. 212 indiana health law review [vol. 15:189 user as a criminal was not deserving, the correlation between drug use and crime made the association believable. moreover, according to schneider and ingram, deviants are not only viewed as undeserving of public benefits, but are also viewed as most deserving of punishment, often in the form of criminal sanctions.122 evidence from public discourse surrounding past drug epidemics offer support for the claim that the poor are more likely to be constructed as undeserving of benefits, like treatment. drug policy historian courtwright has documented that as the demographics of the target population of drug users changes from the upper middle-class to poor or from the mainstream to the marginalized, public preferences shift from supporting treatment as a solution to supporting criminal sanctions and incarceration of the user and his supplier.123 unlike past drug epidemics, the current opioid epidemic has been characterized as a “white” problem and as a problem that affects not only the poor, but the middle-and upper-class as well. since the middle-class is constructed as a deserving class, schneider and ingram’s typology would predict that society would support policy solutions that benefit the target population of drug users, as opposed to punishing them.124 the demographic changes to the target population noted supra in part iii.a.2. support this contention as the target population for the opioid epidemic includes categories of persons, like the middle-class, that are socially constructed as more deserving of policy benefits and less deserving of punitive solutions. but does the evidence support this theorized shift in public support? 3. evidence of shifts in public opinion on drug policy according to courtwright, legislators have historically perceived public support for a criminal justice approach to problem drug use.125 he attributes this legislative perception of public support to “a key electoral group, middle-class suburban voters, [who] remained convinced that the punitive drug war was the only thing standing between their children and a flood of drugs.”126 to this electoral group, any other approach, including the health approach, was too risky, as it communicated to their children that they could experiment with drugs and then just seek treatment.127 the punitive, or criminal justice approach, also pleased religious conservatives whose votes were becoming “increasingly important in the political equation.”128 122. schneider & ingram, supra note 15. 123. courtwright, dark paradise, supra note 18. 124. schneider & ingram, supra note 15. the social construction of the affected population is not the only construction that affects public opinion and subsequently available legislative solutions. id. certain groups may be viewed by the public as undeserving of public benefits but are also politically powerful groups. id. a group’s political power can serve as a moderator for the effects of social construction. id. 125. courtwright, dark paradise, supra note 18. 126. id. at 178. 127. see michael massing, the fix (u. california press 2000). 128. courtwright, dark paradise, supra note 18, at 178. there does not appear to be any formal analysis of drug policy and public opinion congruence. studies analyzing public opinion and 2018] what motivates legislators to act 213 although public support for a criminal justice approach has been historically dominant with few exceptions, public opinion surveys suggest that there has been a shift in public support away from criminal justice solutions and toward health solutions. from 1988 to 2001, surveys indicated that the support for criminal justice solutions declined.129 more specifically, support for arresting drug users and drug dealers dropped from 37% to 30% and 59% to 49%, respectively.130 by 2001, the support for criminal justice solutions was still greater than healthoriented solutions, with support for treatment at a mere 36%.131 yet, the shift away from the criminal justice approach laid the groundwork for the support for the health-approach that was yet to come. by 2014, 67% of respondents supported policy solutions that focused on treatment over prosecution.132 the changes in public support from 1988 to 2014 evidence a steady shift in public drug policy have focused mostly on the degree to which drug policy, as an issue, is salient and on the public’s agenda, as well as what causes drugs to make it onto the public’s agenda. these studies have focused on news media coverage of the drug problem, coding newspaper articles and broadcast transcripts based on content and then conducting either a frequency analysis or an arima analysis to determine whether there has been a change over time in how the media frames the drug problem. such methodology is based on empirical analysis that shows that the saliency of a news media frame increases the likelihood that a frame (1) will reflect the manner in which the public defines an issue, (2) will influence the importance the public assigns the issue, and (3) will influence legislators’ framing of an issue. see e.g. whitford & yates, supra note 79; gonzenbach, supra note 83. 129. interdiction and incarceration still top remedies, pew res. ctr. (mar. 21, 2001), http://www.people-press.org/2001/03/21/interdiction-and-incarceration-still-top-remedies/ [https://perma.cc/cbf8-m5av] [hereinafter, pew 2001]. 130. all survey questions were designed and administered by pew research center for the people and the press, and the survey responses were weighted so that the results were representative of the u.s. adult population. id. 131. notably, public support for “educating about drugs,” which could be argued to be a health promotion solution, also declined from 1988 to 2001. see pew 2001, supra note 129; figure 2. this suggests that the public may have been dissatisfied overall with the effectiveness of government intervention on the issue of problem drug use. 132. these figures summarize the results of a particular survey question used by pew, in which they asked survey respondents whether the government should focus more on “persecuting people who use illegal drugs such as heroin or cocaine” or “focus more on providing treatment for people who use these types of drugs.” america’s new drug policy landscape: two-thirds favor treatment, not jail, for use of heroin, cocaine, pew res. ctr. 1 (apr. 2, 2014), http://www.people-press.org/files/legacy-pdf/04-02-14%20drug%20policy%20release.pdf [https://perma.cc/xfc6-br3t] [hereinafter pew, new policy]. the findings are supported by a recent study by barry et al. see colleen l. barry et al., understanding americans’ views on opioid pain reliever abuse, 111 addiction 85-93 (2016). barry et al. aimed to uncover american’s views on the opioid epidemic. id. although the researchers did not ask respondents to report whether they felt that opioid addicts should be penalized for their actions, or otherwise measure support for criminal justice solutions, they did find substantial support for the health solutions that were considered by legislators prior to passage of cara. id. 214 indiana health law review [vol. 15:189 opinion in support of health approaches to problem drug use over criminal justice approaches.133 this is the type of large and stable shift in public opinion necessary to create a change in legislator support. however, for the shift in public opinion to be most effective in translating to a legislative problem redefinition and a policy change, a coinciding shift in pressure group support for the problem redefinition is ideal. in the following sub-section, i demonstrate how and why pressure groups are theorized to affect legislative problem definition. i then provide anecdotal evidence to support the claim that while pressure groups may have supported a criminal justice approach in the past, pressure groups are likely defining the opioid epidemic as a health problem involving health actors – thus supporting the health shift evidenced in public opinion surveys. c. pressure group considerations 1. the theoretical literature: problem definition, pressure groups & the policy process in the u.s., pressure groups can play an integral part in convincing legislators to adopt a particular problem definition.134 groups compete for legislator time and attention with the goal of being awarded the ability to define the problems that affect their interests.135 legislators look to pressure groups for not only campaign finance and electoral support, but also subject matter expertise, research and even assistance in implementing legislation. as such, changes in pressure group framing can affect the contents of legislation drafted to address the problem.136 in competing to define the problem, groups vie for the ability to narrate the “causal story” by explaining the cause of the problem, identifying who or what is to be blamed for the problem and who should benefit from the problem 133. see pew, new policy, supra note 132, at 1. the 2014 support for treatment spanned “nearly all demographic groups,” with support being about the same whether or not the individual viewed drug abuse as a crisis in their own local neighborhood (64% vs. 68%). id. however, republicans did show less support for treatment (51%) than democrats (77%) and independents (69%), which is not surprising since the 2001 pew report, supra note 129, showed that less republicans considered addiction a disease than democrats (61% v. 30%). id. this suggests that ideology may affect the strength of support for treatment solutions. id. at 8. aside from ideological differences, differences in support for treatment vs. incarceration correlated with race and ethnicity with 81% of blacks supporting treatment over incarceration, compared to 66% of whites and 61% of hispanics. id. at 9. 134. baumgartner et al., supra note 14; schneider & ingram, supra note 15; stone, supra note 8. 135. stone, supra note 8; joshua l. kalla & david e. broockman, campaign contributions facilitate access to congressional officials: a randomized field experiment, 60 am. j. pol. sci. 545-58 (2016). 136. baumgartner et al., supra note 14; schneider & ingram, supra note 15; stone, supra note 8; beth l. leech, lobbying and influence, in the oxford handbook of american political parties and interest groups 534-51 (l. sandy maisel & jeffrey m. berry eds., 2010). 2018] what motivates legislators to act 215 solution.137 pressure groups use these causal stories to assign blame and responsibility for the problem, empower certain actors as the “fixers” of the problem, create new political alliances, and “either challenge or protect an existing social order.”138 by defining the problem with causal stories, groups also limit the policy solutions that legislators are left with to those that best align with their interests.139 according to stone, pressure groups use common strategies to define the problem for legislators in ways that (1) attribute blame to outside groups, (2) limit alternative solutions, and (3) strategically define the target populations.140 a. problem definition strategies: attributing blame by analyzing causal stories used in the policymaking process, stone was able to identify the following common causal theories—which argue that the policy problem (1) was an accident of nature or fate, (2) was the result of “human agency,” (3) was a problem created by a “few bad apples,” (4) was the result of hidden motives, (5) was the result of a calculated risk that someone took, (6) was the result of a purposeful action but one for which the individual or group could not have possibly known the outcomes for, or (7) was the result of such a complex process that it is simply out of the actors’ control.141 examples of such strategies can be found in recent causal stories used to describe the cause of the current opioid epidemic. for example, the attorney general in ohio recently pursued litigation against five pharmaceutical companies for causing the current opioid epidemic in ohio by intentionally misrepresenting the addictive properties of opioid prescription painkillers.142 he was quoted as saying, “they knew they were wrong, but they did it anyway—and they continue to do it.”143 in doing so, the attorney general was blaming the pharmaceutical companies for taking a calculated risk where the benefits, for the company, would outweigh the costs and asserting that the opioid crisis in ohio was a result of willful acts. this shifts the blame to the pharmaceutical companies as the actors that caused the epidemic. it also suggests to federal legislators that the cause of the opioid epidemic was pharmaceutical companies’ greed and that the appropriate solutions to the problem include regulation and punishment. another example of strategic use of causal stories by a pressure group is physicians’ counter-story to the causal story that blames physicians for causing the epidemic by overprescribing opioid painkillers. as a group, physicians would want to shift blame from the medical community at large, to the “few bad 137. stone, supra note 8. 138. id. at 223-24. 139. rochefort & cobb, supra note 7; stone, supra note 8. 140. stone, supra note 8. 141. stone, supra note 8, at 233. 142. press release, ohio attorney gen. mike dewine, attorney general dewine files lawsuit against opioid manufacturers for fraudulent marketing; fueling opioid epidemic, (may 31, 2017), www.ohioattorneygeneral.gov/media/news-releases/may-2017/attorney-generaldewine-files-lawsuit-against-opio [https://perma.cc/d9dy-shcn]. 143. id. 216 indiana health law review [vol. 15:189 apples”—doctors who were intentionally and willfully trafficking in illegal drug sales. an example of a legislative policy solution that aligns with this counter causal story is a prescription monitoring program that identifies the bad apples who are overprescribing. such a solution targets the bad seeds, as opposed to punishing the medical profession as a whole. b. problem definition strategies: limiting alternative solutions pressure groups craft causal stories not only to attribute blame, but also to identify a causal theory that supports a particular legislative solution. causal stories are powerful in that they limit the policy alternatives, or acceptable solutions (“alternatives”) to the problem.144 so, for example, if the pharmaceutical industry’s willful acts have caused the current opioid epidemic, then the policy solutions available involve regulating or penalizing the pharmaceutical industry. whereas, if physicians are to be blamed for the current opioid epidemic, then the alternatives are prescription monitoring programs and punishing the bad apples. neither of these causal stories call for penalizing the drug user, because the drug user did not cause the problem—the pharmaceutical industry and the physicians did. however, if we again shift back to blaming the drug user for his problem drug use, blaming his poor moral character for failing to prevent him from resisting sinfully pleasurable indulgencies if they are within his reach, then a criminal justice solution is more likely. for example, if the cause of the increase in heroin use is, instead, the influx of heroin from mexico that inevitably results in an increase in heroin use because populations at risk of problem drug use cannot help but use if the supply is available, then building a wall between the u.s. and mexico and punishing those who supply and possess heroin is a viable solution to the problem.145 therefore, she who tells the story has the power to limit the policy alternatives available by the way that she attributes the cause of the problem.146 in sum, the causal story limits the policy alternatives available to policies that address the cause of the problem, and if pressure groups describe problem drug use as a health problem that involves health actors, legislators are more likely to support a health solution. in order to best limit the policy alternatives to their desired choices, pressure groups utilize certain strategies when deciding which cause of the problem to focus on in their causal stories. according to stone, some common strategies used to limit alternative solutions include: (1) using the causal narrative to make the preferred alternative the only apparent solution, (2) “focus[ing] on one part of the causal chain and ignor[ing] others that would require politically difficult or costly policy actions,” (3) in analyzing the evidence, focusing on consequences that 144. rochefort & cobb, supra note 7; stone, supra note 8. 145. khn morning briefing: trump blaming mexico for n.h.’s opioid crisis exposes lack of understanding of the epidemic, kaiser health news (aug. 4, 2017), http://khn.org/morningbreakout/trump-blaming-mexico-for-n-h-s-opioid-crisis-exposes-lack-of-understanding-of-theepidemic/ [https://perma.cc/2cbd-ja53]. such a supply driven causal theory also attributes blame to the supplier who keeps in abundant supply the irresistible substance. 146. rochefort & cobb, supra note 7; stone, supra note 8. 2018] what motivates legislators to act 217 make their preferred alternative appear to be the best solution, and (4) ensuring that the alternative hurts the most powerful constituents, or “advantaged” targets least,147 but still appears to be best for the social good148 and punishes any social deviants.149 examples of such strategies can be found not only in drug policy, but in health policy in general. for example, s. bryn austin demonstrated how in the late 1980s to early 1990s public health officials teamed up with the food industry, most notably, conagra, inc., a manufacturer of a new food brand healthy choice, to battle obesity.150 although there was not much scientific evidence that demonstrated a link between dietary fat and poor health outcomes, it was dietary fat that was focused on in the causal chain of obesity. nestlé’s stouffer’s lean cuisine division soon joined the movement, investing money in what was then called project lean (low-fat eating for american now). by limiting the focus on the causal chain to dietary fat, these groups were able to limit the alternative solutions to educating the public on the harmful effects of fat and the benefits of a low-fat diet, meanwhile profiting from increased sales of their new diet food lines.151 the power of narratives extends beyond drug policy. 2. theoretical literature: pressure group influence the preceding sub-section provided evidence of the role that pressure groups play in the problem definition discourse. the following sub-sections explain additional factors that may influence a legislator’s receptiveness to a pressure group’s narrative. since the literature on interest group influence is distinct from that discussing administrative agency influence, i have presented summaries of each literature separately. a. interest group influence and congress influence is often narrowly defined by the interest group literature as “the power to change a public policy or to defeat efforts to have the policy changed.”152 the ways that interest groups are theorized to influence policy are (1) by providing campaign contributions, (2) by providing legislators with insight as to the preferences of their constituents and mobilizing its members for or against a legislator, and (3) by acting as “service bureaus” that provide research, information, and popular support.153 (1) campaign contributions and pressure group resources much of a legislator’s campaign funds come from interest groups.154 it is hypothesized that legislators pay special attention to donors who donate 147. schneider & ingram, supra note 15. 148. stone, supra note 8, at 260. 149. schneider & ingram, supra note 15, at 104. 150. s. bryn austin, constructing the need for “low fat” food, in social problems: constructionist readings 180, 180-88 (donileen r. loseke & joel best eds., 2003). 151. id. 152. leech, supra note 136. 153. id. at 536. 154. benjamin i. page, larry m. bartels & jason seawright, democracy and the policy preferences of wealthy americans, 11 persp. on pol. 51, 51-73 (2013). 218 indiana health law review [vol. 15:189 substantial money to campaigns because the money can buy advertising to help increase the chances that the legislator will be re-elected.155 further legislators may give preferential treatment to interest groups who donate to other legislators’ campaigns, based on the belief that they may be able to elicit funds from the group in the future.156 scholars theorize that legislators may see campaign contributions as shared values, preferences, or expertise.157 a recent study by kalla and broockman found that interest groups who donate to congressional campaigns have the most access to having their opinions heard.158 access to congress does not automatically mean that congress will adopt the groups’ position, but it does increase the likelihood that the group will be able to influence the framing of policy.159 the degree to which legislators believe that campaign finance is important is reflected in the amount of time legislators spend per day trying to raise campaign funds.160 perceptions of the importance of campaign finance is also reflected in interest group campaign finance activity of groups that have high exposure to regulation. more specifically, interest groups with such potential exposure are much more likely to contribute campaign funds to legislators who have committee seats in policy areas that affect that group.161 although theoretically and anecdotally, access to legislators seems likely to result in interest group influence, there is insufficient quantitative evidence to show a causal impact of contributions.162 while some studies evidence a correlation between financial contributions to legislators and policy outcomes, others do not.163 leech suggests this may be because all such studies focus on dichotomous, yes or no votes on a policy as the outcome measure, thereby ignoring other parts of the policy making process where interest groups may have 155. id. 156. kalla & broockman, supra note 135, at 547. 157. id. 158. id. 159. see, e.g., john mark hansen, gaining access: congress and the farm lobby, 1919-1981 (1991); richard l. hasen, lobbying, rent-seeking, and the constitution, 64 stan. l. rev. 191, 191-253 (2012); richard l. hall & alan v. deardorff, lobbying as legislative subsidy, 100 am. pol. sci. rev. 69, 69-84 (2006). 160. legislators report spending several hours per day to raise campaign funds. ryan grim & sabrina siddiqui, call time for congress shows how fundraising dominates bleak work life, huffington post (dec. 6, 2017), http://www.huffingtonpost.com/2013/01/08/ call-timecongressional-fundraising_n_2427291.html/ [https://perma.cc/76p9-4czt]. 161. eleanor n. powell & justin grimmer, money in exile: campaign contributions and committee access, 78 j. pol. 974, 974-88 (2016); stephen ansolabehere & james m. snyder, jr., money and institutional power, 77 tex. l. rev. 1673, 1673-1704 (1999). 162. baumgartner et al., supra note 14; justin fox & lawrence rothenberg, influence without bribes: a noncontracting model of campaign giving and policymaking, 19 pol. analysis 325, 325-41 (2011). 163. leech, supra note 136. 2018] what motivates legislators to act 219 influenced the policy process—for example by affecting which issues reach the agenda or how legislators talk about a policy problem.164 baumgartner et al. argue that campaign contributions and lobbying expenditures alone do not adequately measure the resources that groups have available to them to affect a policy redefinition, which is why studies sometimes find a relationship and other times do not.165 for example, the number of former congressional staffers employed by an organization166 may be considered a more predictive resource than campaign contributions. to improve upon campaign contributions as measures of influence, baumgartner et al. used disclosures under the lobbying disclosure act of 1995 to identify other resources, like the number of lobbyists per organization who were former congressional staff members or high-level officials.167 disclosures were also used to identify campaign contributions and soft-money contributions to parties for two successive two-year election cycles before the policy outcome.168 even though baumgartner et al. defined interest group resources more broadly than their predecessors, they still found little correlation between a pressure group’s resources and specific policy outcomes. an individual pressure group’s resources did not seem to predict whether its desired policy outcome would be adopted.169 baumgartner et al. then shifted their analysis from the individual level to the population level and compared the aggregate resources of all interest groups for each “side” of a policy issue.170 in their definition of interest group resources, baumgartner et al. included high ranking officials in government, including administrative officials.171 their subsequent analysis showed that the side supported by the greatest number of high ranking government officials was most likely to be successful.172 the higher ranking the government official, the better.173 further, if a “side” was seeking to redefine a problem, it was more likely to succeed if supported by high ranking government officials.174 not surprisingly, the president being on the side of the policy change was also a significant 164. id. 165. baumgartner et al., supra note 14. 166. it is presumed that such former staffers still have relationships in congress, relationships that allow these former staffers to influence how a problem is framed and the types of solutions supported. 167. baumgartner et al., supra note 14, found that citizens groups were much less likely than business corporations, trade and business associations, professional associations and unions to file disclosures. they also noted that unions and citizens seemed to work more with the “rank and file” government officials but that businesses had greater access to higher ranking members of the government. id. 168. id. 169. id. 170. id. 171. id. 172. id. 173. id. 174. id. 220 indiana health law review [vol. 15:189 predictor.175 aside from support from high-ranking government officials, a general resource advantage did seem to aid the side mobilizing for policy change, especially during the first two years of mobilization.176 in sum, although campaign contributions and resources at groups’ disposal are believed to affect the groups’ ability to lobby legislators to adopt their problem definition and policy solution, the relationship between lobbying resources and success in doing so is not always evident in the literature. as such, lobbying resources by any one specific organization may not have caused the redefinition of problem drug use as a health problem prior to cara’s enactment. baumgartner, et al.’s work, however, suggests that the “health side” of the problem definition discourse likely had greater lobbying resources, including access to campaign contributions and support from high-ranking administrative officials.177 before such conclusions can be drawn, of course, a systematic analysis of the lobbying resources available to the health side of the problem definition discourse prior to cara is needed. (2) influence as information on constituents’ preferences and as a legislative subsidy groups that contribute to legislators’ campaigns or have access to electoral resources are not the only interest groups that are theorized to affect how a problem is defined or the types of policy proposal adopted to address a problem. interest group theorists have challenged the “exchange theories” of lobbying that depict lobbying as a simple exchange of campaign contributions for votes and propose instead “persuasion theories” that theorize that interest groups are influential because they have access to constituency’s opinions on policy issues, giving legislators information that they would not have otherwise had about how policy actions may affect their re-election prospects.178 unfortunately, there is not much support for this theory, as interviews with lobbyists reveal that when advocating for a policy proposal to legislators, lobbyists use arguments that are “electoral in nature” less than 3% of the time.179 hall and deardorff suggest that interest groups use yet another tool to influence legislators—a legislative resource subsidy.180 hall and deardorff theorize that pressure groups are powerful, not just because they contribute to political campaigns, but mostly because they can also offer “costly policy information, political intelligence and legislative labor,” also referred to as a “legislative subsidy.”181 although hall and deardorff do not explicitly refer to administrative agencies as offering a legislative subsidy, administrative agencies can provide a legislative subsidy just the same, as they provide detailed reports and information on specific subject matters often outside the expertise of 175. id. 176. id. 177. id. 178. hall & deardorff, supra note 159. 179. leech, supra note 136, at 546. 180. hall & deardorff, supra note 159. 181. id. 2018] what motivates legislators to act 221 legislators. while providing this legislative subsidy, both organized interest groups and administrative agencies are in a prime position to define the policy problem. public interest groups, or citizens groups, are especially situated to provide credible and researched expertise and reports, putting them at an advantage for the provision of information in comparison to other interest groups due to their research accuracy and credibility.182 in order for legislators to influence legislation, they require “in-depth policy analysis, reports or expertise” that can be provided by public interest groups thereby saving legislators the time and resources they would have spent on compiling such information.183 “matthews (1960, 182) observed, quoting one senator: ‘they can tell me in thirty minutes or less what it would take me hours to learn through reading and study.’”184 legislators are also aware that reports produced by public interest groups are likely to be received more favorably by the press than reports produced by industries.185 this may be why baumgartner, et. al. found that citizens groups were most likely to be named by legislators as the central actors on an issue,186 as their provision of such reports can be indispensable to defining a policy problem. b. administrative agency influence organized interests are not the only groups that provide legislators with policy-relevant information. federal administrative agencies, even those outside of the cabinet, are another source of policy expertise and information.187 their influence on legislators is independent of the president and his cabinet.188 a longitudinal analysis of the issue attention cycle of the media, public attention, and the legislative activity on problem drug use in the u.s. found that problem drug use only made the public agenda after an administrative agency released reports citing a rise in addiction or overdose deaths.189 policy entrepreneurs within administrative agencies, policy-makers invested in defining a problem in particular manner or in seeking certain policy solutions, can further influence legislative decision-making.190 baumgartner et al. found that 182. jeffrey m. berry, the new liberalism: the rising power of citizen groups (1999); william p. browne, cultivating congress: constituents, issues, and interests in agricultural policymaking (1995). 183. hall & deardorff, supra note 159, at 74. 184. id. 185. berry, supra note 182. 186. according to baumgartner et al., because citizens groups have fewer resources than business interests, they were often spread thin. baumgartner et al., supra note 14, at 242. to succeed, they teamed up with business actors who had access to greater resources. id. if citizens groups were unable to align themselves with interest groups with deeper pockets, they could find themselves in a “david and goliath” situation. id. 187. frederick j. boehmke, sean gailmard & john wiggs patty, whose ear to bend? information sources and venue choice in policy-making, 1 q. j. pol. sci. 139-69 (2005). 188. agendas, alternatives, and public policies, supra note 100. 189. gonzenbach, supra note 83. 190. baumgartner et al., supra note 14. 222 indiana health law review [vol. 15:189 41% of advocates for the adoption of a side on a policy issue were government officials.191 because congress relies on administrative agencies to interpret legislation, as well as implement and enforce it, administrative acceptance of a problem definition and solution is exceedingly important—regardless of whether or not congress is controlled by the same political party for which the president is a member. further, noting the influence of administrative agency officials, organized interest groups often team-up with administrative agency officials that support their lobbying position in the hopes of forming a stronger coalition. the most successful lobbying groups are the ones that work with, not only policy entrepreneurs in congress, but also high-level bureaucrats in the federal administration who support their policy stance on an issue.192 aside from federal administrative agency support, successful problem redefinition has occurred when (1) pressure groups, who were previously absent from discourse, joined and supported the problem redefinition, (2) new networks or coalitions of pressure groups supporting the problem redefinition emerged, and/or (3) there was a substantial and punctuated shift in mobilization and resources to the “redefinition” side.193 in sum, pressure groups, including administrative agencies and interest groups, influence the types of policy proposals adopted, due in part to their influence on legislative decision-making. such influence is further evidenced by an analysis of drug policy history. 3. evidence of pressure group activity in drug policy although a systematic analysis of pressure group involvement in the problem definition of the current opioid epidemic has yet to be published, historical analysis of pressure group activity in drug policy suggests that pressure groups have been active in the problem definition process and have a continued interest in continuing to lobby for the adoption of particular problem definitions and policy proposals. historically, physicians, pharmacists, prescription drug 191. id. (conceptualizing federal agencies, not as pressure groups, but as resources to pressure groups). i conceptualize a government agency as both a resource to organized interests or as advocates and a pressure group in and of itself. after all, government agencies have their own tools of persuasion including relationships with congressional members, the endorsement of the president, and the ability to develop and disseminate supportive research. id. 192. christine mahoney & frank r. baumgartner, partners in advocacy: lobbyists and government officials in washington, 77 j. pol. 202-15 (2015). 193. baumgartner et al., supra note 14, identified the following factors as important predictors of policy change: (1) changes in the types of pressure groups involved, (2) addition or departure of specific pressure groups or pressure group leadership, and (3) the changes of who is on each side. for example, in one case study, there was a change in officials overseeing an executive agency and the new official desired a different policy outcome. to accomplish this, he constructed a new narrative aligned with his policy solution, recruited the support of organized interests and was successful in reframing the policy issue. id. in another instance, business interests entered into the policy debate and introduced a new narrative, which was quickly supported by state governments interested in achieving the same policy goals. id. therefore, formations of new connections, including new coalitions, can also contribute to policy reframing. 2018] what motivates legislators to act 223 manufacturers, and the narcotics bureau (which was later merged with the drug enforcement agency) have had political and strategic reasons for supporting certain problem definitions and policy solutions over others.194 such problem definitions have historically influenced the types of legislative solutions enacted, including whether or not that definition supports health-oriented versus criminal justice oriented legislative solutions,195 and will arguably continue to do so. however, for most of these groups, the role that they may or may not have had in defining the opioid epidemic as a health versus a criminal justice issue has yet to be empirically documented. however, anecdotal evidence suggests that pressure groups have been on the “health-side” of the current policy debate. for example, in the past, and the present, the medical profession has been blamed for creating classes of opiate addicts who were initially prescribed the opiate by a prescriber (“iatrogenic addicts”).196 such accusations have historically mobilized organized interest groups representing these professions, including the american medical association (“ama”) and the american pharmacists association (“apha”).197 although one might predict that such groups would always support a health-oriented approach to addressing problem drug use, historically, these groups have supported the approach most aligned with their immediate needs. for instance, the ama has oscillated between supporting the contention that addiction is a disease that necessitates treatment by the medical profession to supporting the claim that addicts were persons with psychosocial personality disorders who must be locked away so as not to do harm to themselves or to society.198 courtwright argues that the ama has advocated for the remedy of treatment most when the addict population was comprised of a class of persons that physicians preferred treating: white, middle-to upper-class populations.199 courtwright contends that when the population of addicts became poorer and lower class, the ama adopted the view that addiction was a result of a personality disorder that law enforcement officials were best suited to handle.200 similarly the apha has supported the addiction as a disease narrative explicitly when doing so aligned with their policy objectives of maintaining a legal supply of opiates to prescribe and include in druggists’ elixirs.201 for subpopulations of users that were marginalized, like chinese immigrants, the apha adopted popular narratives of deviancy and supported punitive solutions.202 the apha drafted early model drug legislation for states and convened working groups to negotiate the terms of the nation’s first large scale opiate regulation, the harrison tax act of 1914, evidencing the medical profession’s influence on early 194. courtwright, dark paradise, supra note 18; musto, supra note 18. 195. el-sabawi, supra note 23. 196. courtwright, dark paradise, supra note 18; musto, supra note 18. 197. courtwright, dark paradise, supra note 18; musto, supra note 18. 198. id. 199. id. 200. id. 201. musto, supra note 18; erlen & spillane, supra note 18. 202. musto, supra note 18; erlen & spillane, supra note 18. 224 indiana health law review [vol. 15:189 drug policy.203 however, when their financial stake in the problem definition disappeared, so did their involvement in the problem definition discourse and their support for a health-oriented disease narrative.204 further systematic analysis is needed to determine whether there has been a marked increase in the medical industry’s involvement in the legislative discourse prior to cara’s enactment and whether their contribution to the discourse supported a health-oriented approach—an approach that was subsequently embodied in cara. however, preliminary evidence suggests that health actors have been supportive of a health-oriented approach. namely congressional testimony by members of the medical industry, supports the claim that problem drug use is a health issue or a disease that needed prevention, education and treatment.205 drug manufacturers may have also influenced the problem definition of drug use as a health issue. historically, the drug manufacturing industry’s support for a health approach was also influenced by their financial stake in the outcome, as was their involvement in the drug policy discourse. in the nascent stage of u.s. drug manufacturing the pharmaceutical industry was dominated by so called “patent” medicine manufacturers who commonly utilized cocaine and opiates in their over-the-counter medication that were marketed directly to consumers.206 it was therefore in their interest to support a health-oriented definition of opiate and cocaine use to ensure its continued legalization. as “ethical drug companies” began to dominate, companies that were more focused on research and discovering new drugs, the needs and interests of the drug industry evolved.207 their support for a health approach dissipated, as did their general involvement in drug policy. however, as new forms of mat develop and demand for opioid reversal medications increase, drug manufacturers have renewed incentives to engage in the drug policy discourse. again, systematic analysis is needed here to identify the causal theories supported by these drug manufacturers and the degree to which such causal stories align with a health-approach. however, defining addiction as a disease of the brain aligns quite well with the access to medication as a solution. aside from the medical industry’s involvement in the problem definition discourse, administrative agency officials have historically had significant influence on the legislative approach to problem drug use. although richard nixon is often remembered for having declared the first “war on drugs,” with subsequent presidents declaring similar “wars,” it was not the president who was 203. musto, supra note 18. these working groups included representatives from physicians associations and the drug manufacturing industry. musto, supra note 18; erlen & spillane, supra note 18. 204. musto, supra note 18. 205. see, e.g., testimony, s. comm. homeland security and government affairs: wisconsin heroin epidemic, 2016 wl 1572172 (apr. 15, 2016) (statement of timothy westlake, m.d., chairman, controlled substances comm.). 206. musto, supra note 18; erlen & spillane, supra note 18. 207. erlen & spillane, supra note 18. 2018] what motivates legislators to act 225 the first to resort to a militarized, criminal response to drugs, but rather, high level bureaucrats in the administrative branch. henry anslinger, of the narcotics bureau (nb), is often cited as the father of america’s criminal justice approach to drug control.208 anslinger began as an upper level bureaucrat in the prohibition bureau during the progressive era and maintained his prohibition era rhetoric for the thirty-two years of his tenure, during which he influenced congress through his emotionally-charged stories and half-truths.209 anslinger fueled fearful, punitive responses to problem drug use and perpetuated the construction of the drug user as a criminal and deviant within the dea, well before the first president declared the first of the many “wars” on drugs that was to come.210 anslinger’s influence is reported to have had a lasting effect on the culture and approach taken by the dea to address problem drug use.211 the dea’s influence on congress did not end when anslinger left. how administrative agency officials have influenced the problem definition of the opioid epidemic has yet to be documented. notably, the dea’s reference to drug users not as deviants or criminals, but as friends, families, co-workers and neighbors in congressional hearing testimony regarding the opioid epidemic suggests that the dea has changed its rhetoric.212 further, although the legislative solutions supported by the testimony focused on decreasing the supply of drugs, the solutions proposed were not exclusively criminal justice oriented, in that they involved and were even partially administered by health actors.213 given baumgartner et al.’s conclusion that administrative agency support of a problem redefinition is important to successful problem redefinition, this anecdotal evidence suggests that shifts in the dea’s problem definition may have influenced the legislative support for less criminal justice oriented solutions and in the least, a facially more health-oriented approach. in conclusion, the contention that pressure groups influence how a policy problem is characterized is evidenced in drug policy history. although a detailed analysis of pressure groups’ involvement in the problem definition discourse prior to cara’s enactment is still needed, anecdotal evidence suggests that certain groups that have been historically active in drug policy may have contributed to support the definition of the opioid epidemic as a problem necessitating a healthoriented solution. v. conclusion in this article, i have provided an interdisciplinary review of theories of 208. id.; see also courtwright, dark paradise, supra note 18. 209. see erlen & spillane, supra note 18. 210. id. 211. id. 212. see testimony, s. caucus on narcotics control: controlled substances quota process, 2015 wl 1643509 (may 14, 2015) (statement of joseph t. rannazzisi, deputy assistant administrator office of diversion control, drug enforcement admin.). 213. id. 226 indiana health law review [vol. 15:189 legislative decision-making and in doing so, provided evidence to support the relevance of these theories to explaining the types of legislative proposals adopted to address the current opioid epidemic. using these theories as a foundation, i proposed that legislators considered local needs, voter preferences, interest group preferences and administrative agency preferences when deciding to adopt a health-oriented approach to the opioid epidemic. more specifically, i provided evidence to support the claim that in adopting a health approach, legislators acted to ensure re-election and create good public policy by a solving a pressing social problem that affected local voters in a manner supported by voters, interest groups and administrative agencies. the evidence presented in this article only demonstrates that such a theory is viable and that additional empirical research is needed to verify its true utility. however, it narrows down the possible influential factors to a manageable number of most likely candidates. it also provides interested researchers and scholars with a framework to verify and build on. moreover, it contributes to the discourse by explaining how changes in the demographics of drug users, particularly changes in the race or class of drug users, or the rural or metropolitan distribution of a drug problem, can factor into a legislator’s decision-making process. even without considering the effects of explicit or implicit racial bias, this article demonstrates that legislators are incentivized to define policy problems in ways that not only result in the adoption of good policy, but also ensure their re-election. legislators, in concert with other actors, construct policy problems and solutions and when such a construction aligns with public opinion and pressure group preferences, that construction is most likely to become an enacted legislative solution. such an acknowledgement is powerful in that it provides advocates with tools with which to affect the policy process and convince legislators to adopt certain policy solutions over others. as applied to the case of drug policy, understanding the factors that convinced congress to abandon its longstanding love affair with ineffective criminal justice solutions and commit to more empirically supported public health solutions,214 will allow advocates to try to prevent congress resorting to ineffective criminal justice solutions when faced with drug epidemics in the future. 214. there is a litany of academic scholarship, comparative examples, and even the federal administration’s own reports that indicate that the u.s. government’s adoption of criminal justice solutions to address problem drug use has not been successful in decreasing the number of overdoses or cases of addiction, causing a former president obama official to declare that the “war on drugs,” the name often used to personify this approach, has failed. see debusmann, supra note 21; see also ysa et al., supra note 20. striking a balance: regulation of raw milk and a new approach for indiana striking a balance: regulation of raw milk and a new approach for indiana christopher m. anderson* i. introduction. .............................. ...... 399 a. history of the pasteurization of milk ................ 401 ii. the arguments in favor and against raw milk...... 407 a. the argument in favor of ra w milk...... ...... 407 b. the argument against raw milk ............... 413 iii. the current state of raw milk regulation ......... 414 a. federal regulation ...................... ..... 414 b. state regulation ....................... ..... 418 1. introduction to state regulation ofraw milk........ 418 2. regulation ofraw milk in indiana ................. 421 iv. conclusion .............................. ...... 433 i. introduction when someone ventures into the local supermarket to pick up a gallon of milk, he is forced to make several decisions. for example, what brand of milk is he going to buy? should he buy the 2% milk? should he buy the more expensive usda certified organic milk or should he buy the conventionally produced milk? is the expiration date far enough away? in most states, however, there is one significant decision that the consumer does not have to make. in fact, he is not even allowed to make it: "should i purchase the pasteurized milk, or the un-pasteurized (raw) milk?" this decision is foreign to most consumers in the united states because with few exceptions, states do not allow raw milk to be sold j.d. candidate, 2014, indiana university robert h. mckinney school of law, indianapolis, indiana; b.s., 2009, taylor university, upland, indiana. indiana health law review in stores. many states go even further and prohibit the sale of raw milk to consumers anywhere, whether in supermarkets, farmers' markets, or even on the actual farm where the milk was originally produced. although in some states the specific law that mandates pasteurization of milk is only a decade or two old, practically speaking, most milk intended for human consumption has been regularly pasteurized since the early 1920s. 1 notwithstanding the fact that pasteurized milk is the only type of milk with which most people are familiar, in the past few years there has been a steadily growing furor by raw milk advocates who want the freedom to purchase and drink raw milk. advocates, in support of their desire to drink raw milk, cite reasons ranging from the claimed superior taste and nutrition of raw milk, to simply wanting to support local dairy farmers and avoiding foods that have been through more processing. 2 on the other side of the debate, many in the government and health fields claim that pasteurization is necessary for all milk in order to prevent people from getting sick, or even dying, from drinking tainted milk.3 they claim that this is especially true for children, pregnant women, and the elderly. 4 in their opinion, there is no reason to allow raw milk to be sold when pasteurization is a safe, effective, and cheap way of protecting consumers from the dangers of raw milk.5 although the potential dangers of drinking raw milk are undoubtedly real, states, in particular, indiana, should allow the sale of raw milk. the key is to find a balance 1 ind. state bd. of animal health, indiana state board of animal health report on the issue of selling unpasteurized milk to consumers 10 (2012). 2 david e. gumpert, got raw milk., the boston globe magazine, mar. 23, 2008, available at http://www.boston.com/ bostonglobe/magazine/articles/2008/03/23/got-raw-milk/?page=full. 3 raw milk misconceptions and the danger of raw milk consumption, u.s. food and drug admin., http://www.fda.gov/food/ foodborneillnesscontaminants/buystoreservesafefood/ucm247991.htm (last updated nov. 1, 2011). 4 id. 5 id. 400 vol. 11:1 striking a balance: regulation of raw milk between giving consumers the right to purchase and consume raw milk, while at the same time going to great lengths to ensure that the raw milk is as safe as possible. this balance can be found by ensuring that milk producers meet certain standards, limiting the locations where raw milk can be sold, and mandating the placement of warning labels or disclaimers highlighting the possible dangers of raw milk. in addressing the issue of the regulation of raw milk, this note will first lay out the history of the pasteurization of milk. the second section of the note will describe the arguments for each side of the raw milk debate, including legal, policy, and health arguments. in the third section, the note will look at the current state of raw milk regulations and will briefly address current federal regulations, and then it will proceed to discuss the regulatory approaches taken by different states. the section will then look at the current state of raw milk regulation in indiana and the proposed changes to those regulations. the note will conclude by arguing how and why indiana should adopt looser regulations that allow raw milk to be sold in certain places. a. history of the pasteurization of milk humans have consumed milk for quite some time.6 traditionally, however, it was not viewed as the grave health danger that the health community considers it today.7 in fact, the idea of trying to regulate milk to make it "safe" for consumption did not firmly take hold until the beginning of the twentieth century when large numbers of people were moving from the countryside into the cities.8 this urbanization of the nation, which started in the early and mid-1800s, dramatically altered the relationship 6 damian c. adams, michael t. olexa, tracey l. owens & joshua a. cossey, deja moo-: is the return to public sale of raw milk udder nonsense, 13 drake j. agric. l. 305, 307 (2008). 7 david e. gumpert, the raw milk revolution: behind america's emerging battle over food rights 42 (2009). 8 id. 2014 401 indiana health law review between individuals and the milk that they consumed. 9 as cities grew and urban populations became denser, milk production and distribution were required to become more centralized in order to provide enough milk to feed the larger populations. unlike before this movement to the cities when many families had ample room to grow and provide their own food, city-dwellers lacked this space and relied more heavily on others to provide them with milk.10 at the same time that cities were seeing a great increase in populations, demand for milk continued to rise. one of the greatest reasons for this rise was due to the fact that parents were seeking to use milk to feed to their infants.11 in order to meet this growing need, many dairy operations were moved into the city, dramatically cutting down on the distance that the milk had to travel to reach its consumers. however, because cities often lacked the natural-growing food that cows typically ate in the countryside, these urban dairy farmers were forced to come up with new, innovative ways to feed their cows. 12 one widely used source of food for the cows was called swill, which resulted in swill milk.13 this swill was the waste left over after the beer brewing process. 14 as a result of its widespread use, many urban dairy farms were set up in close proximity to breweries.1 5 the process began when "corn and barley would be fermented to make vodka and whiskey, and the leftover grains, their nutrients depleted, would be fed to cows housed in adjoining buildings."16 however, as dairy farms began to move to the city, grow larger, and use this alternative feed for the cows, the health of the cows began to deteriorate.' 7 swill negatively affected the cows, as did the lack of proper sanitation resulting from 9 id. 10 id. 11 donna m. byrne, raw milk in context, 26 j. envtl. l. & litig. 109, 126-27 (2011). 12 id. 13 id. 14 id. 15 id. 16 gumpert, supra note 7, at 43. 17 i~d 402 vol. 11:1 striking a balance: regulation of raw milk the large number of cows being kept inside dense, dirty areas. 18 robert hartley, a man who extensively investigated the urban dairy industry during the 1840s, described the scene as follows: if the wind is in the right quarter, he will smell the dairy a mile off; and on reaching it, his visual and nasal organs will, without any affection of squeamishness, be so offended at the filth and effluvia which abounds, that stillslop milk will probably become the object of his unutterable loathing the remainder of his life. his attention will probably be first drawn to a huge distillery, sending out its tartarian fumes, and, blackened with age and smoke, casting a somber air all around. contiguous thereto, he will see numerous low, flat pens, in which many hundreds of cows, owned by different persons, are closely huddled together, amid confined air, and the stench of their own excrements. he will also see the various appendages and troughs to conduct and receive the hot slush from the swill with which to gorge the stomachs of these unfortunate animals, and all within an area of a few hundred yards.19 along with the health of the cows, the quality of the milk they produced quickly deteriorated. 20 it was at this time that the "swill" milk began to sicken a large number of people, and its consumption even resulted in widespread and devastating outbreaks of tuberculosis among the population. 21 other illnesses that were attributed to consuming the raw milk were typhoid fever, diphtheria, and 18 id. 19 id. 20 byrne, supra note 11, at 126-27. 21 gumpert, supra note 7, at 17. 4032014 indiana health law review severe streptococcal infections. 22 according to the centers for disease control and prevention, approximately 25 percent of food-borne illness stemmed from raw milk consumption at that time.2 3 as people continued to get sick from the swill milk, a strong demand for milk from country farms started to rise. this milk, which was seen as more "pure and wholesome," also resulted in fewer illnesses than swill milk.2 4 as urbandwellers actively sought out country milk, instances of fraud became more common. with increasingly centralized sources of milk, and the technology to transport milk into the cities from long distances, it was less likely than ever that a milk consumer would actually have personal contact with the dairy farmer from where the milk came. for this reason, it was easy for milk transporters to claim that their milk was wholesome milk from the country, when in reality it was from one of the urban swill dairies. 25 the occurrence of this milk fraud, along with the frequent illnesses brought about by the often-contaminated swill milk, led to a widespread push for the government to ensure that dairies were producing milk that was not likely to cause sickness. in 1910, large cities, such as new york city, had two options that would help ensure safer milk. first, new york city could have mandated dairies to be certified in order to sell milk. secondly, it could have mandated pasteurization of all milk being sold.26 certification of dairy farms was already being used to some extent by private certifiers, which resulted in safer, but much more expensive milk. however, extending this certification process to all dairies wishing to provide milk would be economically costly as it would require more labor to carry out the certification testing and more capital to meet the certification standards. 27 certification would require vast improvements in sanitation standards in cities, 22 id. 23 id at 18 24 byrne, supra note 11, at 126-27. 25 id. 26 id. at 127. 27 id. 404 vol. 11:1 striking a balance: regulation of raw milk and more money and labor would be needed to carry out the government inspections of the dairies and their milking practices. additionally, the dairy farmers would need to have more money to pay for their improved sanitation standards and also to continuously test their milk for diseases such as tuberculosis. 28 certification could work, therefore, but not without substantial commitment of time and money by both the government and farmers. pasteurization, the second option, had been used since the 1890s as a method to purify milk. 29 pasteurized milk was somewhat looked down upon because it was "cooked."30 however, pasteurization would be a much cheaper solution than dairy farm certification, and it could easily be applied to any and all milk intended for human consumption. with widespread use of pasteurization, there would be no need for the costly reforms of sanitation measures or expensive tuberculosis tests performed by farmers. all milk could be thoroughly cooked and thereby deemed "safe" for consumption. 31 further, as technological advances allowed a much greater quantity of milk to be produced and delivered to meet an ever-increasing demand, pasteurization would be a very quick solution that would not inhibit the speed and efficiency of dairies. 32 given these two options, cities, one by one, ended up opting toward the required pasteurization instead of the certification process. the first cities to require pasteurization were chicago, new york, boston, philadelphia, milwaukee, and san francisco, in that order. 33 although mandated pasteurization in these cities eventually became standard, it did not always come easy. for example, chicago experienced eight years of "political contestation" until full pasteurization was mandated. 34 28 id. 29 id. 30 id. 31 id. 32 id. 33 gumpert, supra note 7, at 46-47. 34 id. 2014 405 indiana health law review nevertheless, pasteurization of milk was widespread across the nation's cities by the 1920s. 35 the federal government, however, did not step in until the mid-1920s, and even then, it merely made a recommendation that milk be pasteurized; it did not set out any required pasteurization until much later. in 1927, the federal government created new standards for milk under the milk importation act. this act addressed both the production aspect and the transportation of milk across state lines. 36 the food and drug administration (fda) created its own rules, forming what would later be known as the pasteurized milk ordinance. 37 it was not until 1974 that fda regulations actually required the pasteurization of milk, and it only covered milk that was transported between states.38 the enforcement of these regulations was placed on hold due to a complaint from a raw milk dairy farmer, but in 1982 the agency drafted new rules that would require pasteurization of all milk for human consumption that traveled across state lines.39 when the newly drafted rules were not adopted right away, a consumer advocacy group, public citizen, sued the department of health and human services (hhs) in order to force the adoption and promulgation of the rules. 40 in public citizen v. heckler, public citizen used a large amount of evidence to demonstrate to the court why raw milk is dangerous for human consumption. 41 hhs, on the other hand, only provided a minimal amount of evidence to try and show that the drafted rules would not be effective. 42 in the end, the court ruled in favor of public citizen, holding that hhs could not arbitrarily refuse to ban the interstate sale of raw milk.4 3 35 gumpert, supra note 2. 36 adams, olexa, owens & cossey, supra note 6, at 312-13. 37 id. 38 id. 39 id. 40 id at 313. 41 id. 42 id. 43 id. 406 vol. 11:1 striking a balance: regulation of raw milk in 1987, the fda drafted its current regulations on raw milk, which, with the exception of some varieties of aged cheese, prohibit the sale of raw milk across state boundaries. 44 because the federal regulations only prohibit the interstate sale of raw milk, they do not pose a preemption problem for states wanting to adopt their own rules covering the sale of raw milk within the state.45 as a result, states have taken the liberty to adopt their own regulations, resulting in differing standards across the united states.46 ii. the arguments in favor and against raw milk a. the argument in favor of raw milk raw milk may contain certain bacteria that, when consumed, cause the person to become very sick and possibly even die. the federal government takes these risks so seriously that recently a top fda official publicly claimed that drinking raw milk is so dangerous that it is like "playing russian roulette with your health."47 the question, then, is why some consumers continue to drink raw milk when pasteurization is such a cheap and effective way of reducing dangerous pathogens in milk. there is a long list of reasons. raw milk advocates believe that raw milk is healthy for them and that the pasteurization process actually destroys much of the beneficial bacteria that are originally in the milk.4 8 behind these assertions are hundreds of examples where raw milk somehow improved the health of the consumer, and also there are some instances where the consumer relies on the raw milk to maintain his health.49 further, in response to those who say that raw milk is not safe to consume, raw 44 id. 45 id. at 314. 46 id. at 314-15. 47 kammi l. rencher, food choice and fundamental rights: a piece of cake or pre in the sky., 12 nev. l.j. 418, 421 (2012). 48 id. 49 id. at 422. 4072014 indiana health law review milk advocates remind the naysayers that just because milk is pasteurized does not mean that it is completely safe, as it can still contain harmful pathogens.5 0 in fact, pasteurized milk reportedly sickens approximately 600 individuals every year.5 1 raw milk advocates point to several outbreak of illnesses directly attributed to pasteurized milk. for example, in 1983 forty-nine .individuals became ill and fourteen individuals died from pasteurized milk that had been contaminated with the deadly disease listeria prior to pasteurization. 52 in 1985, 16,000 individuals were sickened by pasteurized milk that was contaminated with salmonella. 53 in 1994, salmonella in ice cream, made from pasteurized milk, caused 224,000 individuals to become sick.54 in 2006, over one thousand prisoners in california fell ill due to campylobacter in pasteurized milk.5 5 finally, in 2007, three individuals died as a result of drinking pasteurized milk contaminated with listeria.56 the fda and centers for disease control and prevention respond to those advocates by using statistics to show that the percentage of individuals getting sick from raw milk is much higher than the percentage of people getting sick from pasteurized milk, therefore showing that raw milk is much more dangerous.57 raw milk advocates, however, believe that the government's statistics are misleading and biased against raw milk. the statistics are misleading because when compiling the reports of illnesses, the government combines instances caused by any kind of raw dairy, including "cheese produced under known unsanitary conditions, milk intended for pasteurization (and therefore not subject to strict sanitary practices), and cases where raw milk takes the blame by default," such as 50 id. 51 id. 52 id. 53 id. 54 id. 5 id. 56 id. 408 vol. 11:1 striking a balance: regulation of raw milk where the health officials list raw milk as the source of the illness without actually tracing the illness to the milk.58 further, even if someone is more likely to become sick from drinking raw milk than pasteurized milk, the number of reported people getting sick from raw milk annually is extremely small. from 1973 until 2005, this number averaged fifty-four individuals per year. the estimated seventy-six million individuals sickened every year from all contaminated foods makes this number appear even more insignificant.5 9 raw milk advocates also point out that when illnesses occur from raw milk consumption, the outbreaks tend to be local and only affect a few individuals. outbreaks caused by pasteurized milk, on the other hand, tend to affect a much larger group of consumers spanning across the entire nation. another favorite point made by some raw milk advocates is that despite the cdc's dire warnings that individuals can die from consuming raw milk, no one has actually died from drinking raw milk since at least 1998.60 the two deaths since 1998 that the cdc had attributed to raw milk consumption were found to have been caused by consumption of queso fresco cheese, which is a cheese that is not legal under the fda's requirements and that is often produced in unsanitary conditions.6 1 next, raw milk advocates believe that as a result of the cooking process which pasteurized milk goes through, pasteurized milk contains substantially less nutrition than raw milk.6 2 some of the vitamins in milk, for example, are partially removed when the milk is pasteurized. 63 the amounts of both vitamin b and vitamin c can be decreased by twenty percent.64 the whey protein can be reduced up to 58 id. at 422. 5 id. 60 david gumpert, the power of numbers in the war over raw dairy, the complete patient (feb. 19, 2011, 2:48 pm), http://thecompletepatient.com/article/201 1/february/19/power-numberswar-over-raw-dairy-how-cdc-came-admit-death-wasnt-categorized. 61 id. 62 byrne, supra note 11, at 115-16. 63 id. 64 id. 2014 409 indiana health law review eighty percent.6 5 not only are vitamins seriously reduced, but pasteurization can also destroy some of the bacteriafighting substances that raw milk advocates claim help keep the raw milk safer. this has been shown in studies where immunoglobulin domains and antibodies, which both attack bacteria that affect cows, have been destroyed by the pasteurization process. 66 a 2005 european study also provides support for raw milk advocates. the study looked at the health of school children who drank raw milk versus the children who did not, and the study concluded that drinking raw milk may actually protect against developing asthma or allergies. while the study did note the dangers of drinking raw milk, it concluded by mentioning that a "deepened understanding of the relevant protective components of farm milk [raw milk] and a better insight into the biological mechanisms underlying this association are warranted as a basis for the development of a safe product for prevention [of asthma or allergies]."67 in other words, in terms of possible health benefits, raw milk is worth another look. in 2011, a second study, the gabriela study, was conducted in switzerland, austria, and germany.68 in the study, 8,334 school-age children were tested, and it was found that there was a definite inverse relationship between raw milk consumption and the prevalence of asthma and hay fever.69 like the 2005 european study, the gabriela study concluded that raw milk may have a protective effect against asthma. when milk is pasteurized, it is heated to a very high temperature that is meant to kill any harmful bacteria in the milk. according to raw milk advocates, this process, which essentially "cooks" the milk, negatively affects how 65 id. 66 id. 67 id. at 116-17. 68 georg loss et al., the protective effect of farm milk consumption on childhood asthma and atopy: the gabriela study, 128 j. allergy & clinical immunology 766, 766 (2011), available at http://download.journals.elsevierhealth.com/pdfs/journals/00916749/piis0091674911012346.pdf. 6 9 id. 410 vol. 11:1 striking a balance: regulation of raw milk the milk tastes. the reason for this is known as the maillard reaction.70 once heated, "the lactose in the milk reacts with amino acids and the reaction changes the flavor of the milk."71 also affecting the taste and nutrition of milk, raw milk advocates say, is homogenization, a process that reduces the size of the fat molecules in the milk. 72 the reduced size of the fat molecules prevents the milk fat from rising to the top of the milk, as is typical in raw milk. because the homogenization of milk is not done for safety but simply for convenience, it would be possible and legal for milk to be sold that is pasteurized but non-homogenized. nevertheless, the processes of pasteurization and homogenization usually go hand in hand.73 one problem with the argument of raw milk advocates, however, is that the tests that prove these claims are hard to come by, a fact that health agencies are quick to point out. while the scientific facts on raw milk's benefits might still be unsettled, raw milk advocates make up for this with a wealth of anecdotal evidence. when one raw milk farmer was being investigated by the cass county, michigan prosecutor's office for allegedly selling raw milk, 232 testimonials were received from raw milk drinkers who were reaching out in support of the sale of raw milk.74 one letter read: "[since i've been consuming raw dairy, my health has improved dramatically. i have osteoporosis and am allergic to the medication the doctor prescribed. i feel so much better physically since i've been enjoying raw dairy. i no longer have muscle and joint pain ... ."7 another raw milk consumer wrote, "i have been consuming raw dairy products for two years. i have noticed a significant decrease in seasonal allergies, asthma and inflammation since i have replaced commercially available 70 byrne, supra note 11, at 117. 71 id. 72 id. 73 id. 74 gumpert, supra note 7, at 84. 75 id. at 85. 2014 411 indiana health law review pasteurized milk with raw milk and cream from pasture-fed cows." 76 finally, another woman wrote: i grew up a 'sick' child. even though my parents thought that they were doing the best for me, the foods that i was being raised on were literally killing me. i was finally diagnosed as an adult with celiac disease and severe lactose intolerance. the pasteurized foods caused 25 years of distress in my gut (from the lack of lactase in commercial dairy) causing severe chronic abdominal pain, chronic fatigue, sleepiness, chronic tonsil infections, diarrhea, constipation to name just a few. since being on raw dairy, i no longer have these symptoms. my gut is getting healthier progressively, the more i feed my stomach these raw foods that are rich in enzymes. my sick gut is healthy now. if you take this blessing away from me, i'll be sick again. the pasteurization process destroys the enzymes my body needs to sustain itself. raw dairy keeps me healthy so that i don't have to be a burden on society. don't we already have enough sick citizens?7 7 while many of the testimonials address how raw milk has helped with asthma or allergies, as alluded to in the 2005 european study and the 2011 gabriela study, some individuals have even gone as far as to state that raw milk has significantly helped reduce the effects of adhd, aspergers, autism, and even cancer.78 interestingly enough, these arguments in favor of raw milk's health benefits are not new. milk was prescribed by "physicians of the ages to help cure all manner of diseases." 79 as an example, there is a book that was published in 1905 titled milk diet: as a 76 id. 77 i[d. 78 id. at 89-91. 79 id. at 17. 412 vol. 11: 1 striking a balance: regulation of raw milk remedy for chronic disease.80 a doctor wrote the book as a recommendation that raw milk be used to cure "everything from asthma to rheumatism to high blood pressure."8 1 although raw milk advocates may not have an overwhelming amount of scientific evidence behind them, it is apparent that raw milk drinkers across the country are passionate about their milk and truly believe in its health benefits. b. the argument against raw milk while raw milk advocates are extremely passionate about the benefits of raw milk, those who believe that raw milk is too dangerous are just as determined to fight against allowing raw milk to be sold. first and foremost is the risk that raw milk poses. raw milk can contain several different harmful bacteria and viruses, such as campylobacter, e. coli, listeria, rabies, salmonella, anthrax, staphylococcus, tuberculosis, typhoid fever, and yersiniosis. 82 although pasteurization of milk does not completely ensure consumption of safe milk, the pasteurization process certainly kills many of these potential harmful bacteria. even though there is a risk of getting sick from consuming either pasteurized or raw milk, the cdc and the fda rely on a 1998 study that shows that out of the fortysix outbreaks between 1973 and 1998 that were caused by consuming raw milk, forty of those outbreaks occurred in states that made the sale of raw milk legal.8 3 the authors of the study point out that it was most likely the easier access to raw milk that led to the outbreaks. 84 therefore, if the states had not allowed the sales of raw milk, the outbreaks may have been entirely prevented.85 while the potential dangers of consuming raw milk make up a large part of the argument against raw milk, the 80 id. 81 id. 82 adams, olexa, owens & cossey, supra note 6, at 307. 83 byrne, supra note 11, at 114. 84 id 85 id. 2014 413 indiana health law review remainder of the argument focuses on refuting the health claims made by raw milk advocates. for example, in a 2011 document titled, raw milk misconceptions and the danger of raw milk consumption, the fda attacks the health "myths" of raw milk point by point. the document, which cites scientific research, makes several counterclaims. some examples of points made by the document are: raw milk does not cure lactose intolerance; raw milk does not cure or treat asthma or allergy; there are no beneficial bacteria in raw milk for gastrointestinal health; raw milk is not nutritionally superior to pasteurized milk; pasteurized milk is safer than raw milk; and finally, raw milk does not contain natural antimicrobial components that make milk safe.86 after the fda posted this document, the weston a. price foundation, an organization that promotes consumption of raw milk, authored a "rebuttal to the fda article," where every point made by the fda's document was rebutted.87 iii. the current state of raw milk regulation a. federal regulation in order to better understand and appreciate the current state of raw milk regulation in indiana and other states, a brief background on the federal government's policies in the area of raw milk is necessary. policymaking in the federal government is often focused on the safety of food, which is largely due to the high costs that foodborne illnesses cause when there are outbreaks. it is estimated by the cdc that more than 38.4 million illnesses, 71,500 hospitalizations, and 1,600 deaths each year are caused by food pathogens causing outbreaks.88 the medical costs for the victims in 86 u.s. food and drug administration, supra note 3. 87 weston a. price foundation, rebuttal to the fda article "raw milk misconceptions and the danger of raw milk consumption (2012), available at http://www.realmilk.com/wpcontent/uploads/2012/1 1/rebuttaltofdarawmilkarticle-mar2012.pdf. 88 nicholas r. johnson & a. bryan endres, small producers, big hurdles: barriers facing producers of 'local foods," 33 hamline j. pub. l. & poly 49, 71 (2011). 414 vol. 11:1 striking a balance: regulation of raw milk these outbreaks are estimated to be $164 billion each year.89 further, when foodborne related outbreaks do occur, the outbreaks are often reported in the news, causing the outbreak to have a widespread public impact. because even minor outbreaks are widely reported, the government may feel more pressure to get to the bottom of the problem and to find out exactly from where the pathogen is coming. in spite of the government's extra efforts, methods for determining the source of the outbreak are oftentimes inadequate, and the actual source of the outbreak will frequently go unsolved.90 in 2006, the cdc reported that out of all of the foodborne outbreaks in that year, approximately 3% were related to milk, either pasteurized or raw. however, out of the 3% that were related to milk, 71% were caused by the consumption of raw milk.91 from 1998 to 2008, the fda reported that the drinking of raw milk was behind eightyfive outbreaks, which equaled more than 1,600 individuals actually sickened by the raw milk. 92 of those outbreaks, 187 individuals were hospitalized and two died.93 because many foodborne illnesses or outbreaks are not actually reported to the government, it is estimated that the actual number of outbreaks and illnesses is higher. in regulating food, the federal government establishes specific standards that must be met in order for a certain substance to be labeled "food." similarly, the federal government has standards for "milk." if the product in question does not meet these standards, it cannot be labeled as "milk." according to the federal government, milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. milk that is in final package form for beverage use shall have been pasteurized or 89 id. at 72. 90 id. 91 byrne, supra note 11, at 113-14. 92 id. at 113. 93 id. 2014 415 indiana health law review ultrapasteurized, and shall contain not less than 8 4 percent milk solids not fat and not less than 3 '4 percent milkfat. milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. milk may be homogenized. 94 current regulations mandate that "milk," as is recognized by the government, can only have that identification if, when in "final package form for beverage use," it has been pasteurized or ultra-pasteurized.95 because these regulations determine what can be sold in interstate commerce, the standards for milk mandate that any milk sold in interstate commerce must be pasteurized or ultra-pasteurized.96 in directly addressing the ban on selling raw milk across state borders, 21 c.f.r. § 1240.61 provides that no person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized or is made from dairy ingredients (milk or milk products) that have all been pasteurized, except where alternative procedures to pasteurization are provided for by regulation, such as in part 133 of this chapter for curing of certain cheese varieties. 97 pasteurization, as it is used here, is the "process of heating every particle of milk and milk product in properly designed and operated equipment to one of the 94 21 c.f.r. § 131.110 (2013). 95 byrne, supra note 11, at 117-18. 96 id. at 118. 97 21 c.f.r. § 1240.61. vol. 11:1416 striking a balance: regulation of raw milk temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time."9 8 there is some indication that the current condition of raw milk regulation in the federal government is being reevaluated. in 2011, former house representative ron paul, with five co-sponsors, introduced h.r. 1830, which would legalize the sale of raw milk across state lines.99 in his statement introducing the bill, representative paul stated: hard as it is to believe, the federal government is actually spending time and money prosecuting small businesses for the "crime" of meeting their customers' demand for unpasteurized milk! recently the food and drug administration conducted a year-long sting operation targeting rainbow acres farms in pennsylvania. as a result of this action, rainbow acres' customers will no longer be able to purchase unpasteurized milk from this small amish farm. mr. speaker, many americans who the government wishes to deny the ability to purchase unpasteurized milk have done their own research and come to the conclusion that unpasteurized milk is healthier than pasteurized milk. these americans have the right to consume these products without having the federal government second-guess their judgment about what products best promote health. if there are legitimate concerns about the safety of unpasteurized milk, those concerns should be addressed at the state and local level.100 98 21 c.f.r. § 131.3. 99 h.r. 1830, 112th cong. (2011), available at http://www.govtrack.us/congress/bills/1 12/hrl830#overview. 100 statement introducing unpasteurized milk bill, h.r. 1830, 2011 sess. (2011), http://www.ronpaul.com/2011-05-16/statement2014 417 indiana health law review in december of 2012, senator rand paul introduced a similar bill to legalize the interstate sale of raw milk.101 although both of these bills died in committee, they show that there may be some growing support for changes to be made in federal regulation of raw milk. b. state regulation 1. introduction to state regulation ofra w milk the federal government bans the sale of raw milk across state lines, but it does not directly address intrastate sales. while the federal government may have the authority to do so, it has decided to leave the question of raw milk up to each state so that they can regulate as they see fit. as could be expected in this sort of approach, there is a very broad spectrum of rules across the states. these rules do not seem to be primarily determined by the state's geographical region, by how many people are living in the state, or even by the historical or present importance of the dairy industry in the state. as a general rule, the regulations of the states can be separated into four different approaches. it is important to note that these approaches are simply a means to categorize the laws, and some states may combine multiple approaches presented here. first is the "actual or de facto prohibition on sale" approach.102 in this approach, the state has made it completely illegal to sell raw milk to consumers; all milk intended to be sold for human consumption must be pasteurized. if the milk is sold as pet food, it must also be pasteurized. currently, there are at least eleven states, plus washington, d.c., where raw milk sales and introducing-unpasteurized-milk-bill-hr-1830/ (statement of rep. ron paul). 101 s. 1955, 112th cong. (2011), available at http://www.govtrack.us/congress/bills/112/sl955. 102 adams, olexa, owens & cossey, supra note 6, at 314-15. 418 vol. 11:1 striking a balance: regulation of raw milk distribution are completely illegal. 103 in 1948, michigan led the way in statutorily mandating that all milk sold to consumers be pasteurized.104 second is the "animal-share or leasing" approach.105 this approach takes advantage of a loophole that is usually present when a state has a law that bans the sale of raw milk to consumers. instead of purchasing raw milk, which is illegal, the consumer purchases a part or a "share" of a cow. along with the purchase price, the consumer also pays a monthly fee that covers boarding at a farm for the cow. once every week or two weeks, all the consumers who own part of the cow meet at the farm, or at another location with the farmer, to collect their share of the milk that their cow produced. since the consumers own part of the cow and are simply collecting the milk that their cow produced instead of buying the milk, technically the law is not being broken. courts in several states have adopted this reasoning and have held that cow-shares were not a violation of the law. in 2006, a darke county court of common pleas judge in ohio allowed such a claim because the state statute had not defined the words "sell" or "sold."106 still in other states, such as tennessee, colorado, and alaska, cow-shares are legal because of an explicit statute or agency regulation addressing the issue.107 the state statute in tennessee allowing cow-shares reads: "[n]othing in this part or any other law shall be construed as prohibiting the independent or partial owner of any hoofed mammal from using the milk from the animal for the owner's personal consumption or other personal use."108 however, some courts have held that cow-shares are illegal as interpreted under the law. those courts usually find that the cow-share is an obvious attempt to circumvent the prohibition on sales; because the 103 state by state review of raw milk laws, farm-to-consumer legal defense fund, (june 21, 2013), http://www.farmtoconsumer.org/ rawmilk-map.htm. 104 adams, olexa, owens & cossey, supra note 6, at 315. 105 id. at 314-15. 106 byrne, supra note 11, at 120. 107 state by state review ofraw milk laws, supra note 103. 10 tenn. code ann. § 53-3-119 (2012) (permitting use of milk from hoofed mammal for owner's personal consumption or use). 2014 419 indiana health law review shareowners never take possession of the cow or take care of it, the cow shares look almost identical to milk sales.109 while the states using the de-facto prohibition approach and the states using the animal-share approach both prohibit the sale of raw milk, the de-facto prohibition states have either closed the loophole that allows animal-shares or a court has ruled animal-shares impermissible as interpreted under the statute. animal-share approach states have either declined to close the loophole, or there is a specific court ruling, statute, or regulation allowing them. third is the "limited public sale andlor labeling requirements" approach.110 in this approach, raw milk can be purchased, but only with certain conditions. for example, many states, such as oregon and several midwestern states, only allow raw milk to be purchased at the actual farm where it is produced."' in oregon, on-farm sales are allowed, but the milk producer must not own "more than three dairy cows that have calved at least once, nine sheep that have lactated at least once or nine goats that have lactated at least once." 112 also, not only must the milk be sold at the farm where the milk is produced, but the farmer is not allowed to advertise that the raw milk is for sale. another limitation often imposed on the sale of raw milk is the requirement of placing a conspicuous warning label on the milk container, as is the case in arizona, maine, massachusetts, nebraska, new mexico, new york, pennsylvania, and south dakota. 113 these warning labels oftentimes must include a message saying that the product inside the container is raw milk, and not pasteurized, and therefore harmful pathogens may be present that produce a possible health risk.114 when labels are required, sales are oftentimes allowed both on and off the farm.115 109 byrne, supra note 11, at 120. 110 adams, olexa, owens & cossey, supra note 6, at 314-15. 111 state by state review ofrawmilklaws, supra note 103. 112 byrne, supra note 11, at 119. 113 adams, olexa, owens & cossey, supra note 6, at 317. 114 id. 115 id, 420 vol. 11:1 striking a balance: regulation of raw milk also, in several states that allow raw milk to be sold, there are strict certification and testing requirements that must be met by the raw milk producer in order for the raw milk to be sold to the public.116 a majority of the states have adopted either an exact or a close copy of the grade "a" pasteurized milk ordinance, or pmo.117 this ordinance is an administrative and technical guide that milk producers and state regulators can use as guidelines for proper "milk production, inspection, processing, and packaging to the minutest detail."118 california, one out of approximately ten states that allow retail raw milk sales, 1 9 is an example of a state that requires both a warning label on the milk and that the milk producer be licensed to sell the milk.120 the last approach is the "pet food exception" approach.121 this approach is often combined with the previous "limited public sale and/or labeling requirements" approach.122 in states that use the pet food exception approach, raw milk can be sold in stores, but only if the milk has a label on it that indicates that it is pet food.123 while raw milk is sometimes used as pet food, most raw milk producers in these states are fully aware that people are purchasing the raw milk with the intent of consuming it themselves. 2. regulation ofra w milk in indiana "there are approximately 176,000 dairy cows in indiana on 1,527 dairy farms."124 these 176,000 dairy cows "produce 3.4 billion pounds of milk per year,"125 which puts indiana in 14th place among all the states in total milk production. 116 id. at 306. 117 id. at 312-13. 118 byrne, supra note 11, at 118. 119 id. at 119. 120 adams, olexa, owens & cossey, supra note 6, at 317. 121 id. at 319. 122 id. at 316. 123 id. 124 ind. state bd. of animal health, supra note 1, at 6. 125 id. 2014 421 indiana health law review indiana also "ranks number 2 among states in the production of low-fat ice cream in the u.s."126 these statistics show that while indiana is not the leader in dairy states, the dairy industry plays a significant role in business and culture in the state. for this reason, or in spite of this reason, indiana's government has been involved in regulating milk and milk products since the 1920s.127 the indiana general assembly passed a law in 1925 that required either the pasteurization of all milk meant for human consumption or the testing of the cattle for tuberculin, and in 1935 the milk control act was enacted. 128 a year after the milk control act was enacted, in albert et al. v. milk control board of indiana, the indiana supreme court held that this act was constitutional, stating that "[t]he regulation of the sale of milk for human consumption is a proper exercise of the police power of the state, and such regulation does not amount to the taking of private property without compensation, in violation of section 21, article 1, of the state constitution."12 9 in response to the appellants' argument that the regulation of milk was not a public health matter and was therefore an unconstitutional use of police power, the court noted: if the milk supply of the state is not affected with a public interest and has no relation to public health and the general welfare of our people, then, of course, the act would be invalid. but it is of common knowledge that the milk supply is affected with a public interest and has a direct relation to public health and the general welfare of the people. it is judicially known that milk and its byproducts is a food absolutely essential to thousands of our citizens in order to sustain life, and, if the supply was cut off for only a 126 id 127 id 128 id. 129 albert v. milk control bd. of ind., 200 n.e. 688, 692 (1936). 422 vol. 11:1 striking a balance: regulation of raw milk few days, no one could foretell the dire calamity that would follow.130 currently, the board of animal health (boah) runs the indiana dairy program, per indiana code sections 15-17-2-8 and 15-18-1. indiana law requires that all dairy farms have a permit from boah, and boah has the authority to adopt new rules regarding the production of milk in indiana.131 there are two varieties of milk recognized by boah: grade a milk and manufacturing grade milk. several types of dairy products are produced using grade a milk, such as fluid milk, yogurt, and other dairy ingredients. manufacturing grade milk is often used to make butter, cheese, ice cream, and other frozen desserts. 132 indiana code section 15-18-1-21 sets out indiana's law on the pasteurization of milk. it states: a person may not offer, display for sale, sell, deliver, or have possession of with intent to sell or deliver milk or milk products for human consumption unless every particle of the final mixture of the milk or milk products used in processing or manufacture has been thoroughly pasteurized by equipment approved by the board.133 this statute applies to both grade a milk and manufacturing milk and to all dairy products made from those two grades of milk. an exception exists, however, for certain aged cheeses that do not have to be pasteurized because the aging process kills most of the potential harmful pathogens.134 notably, it has been a long-standing policy of boah to interpret the pasteurization statute in a way that would not prohibit a farmer, his family, or any 130 id. at 691. 131 ind. state bd. of animal health, supra note 1, at 6. 132 id. at 7. 133 ind. code § 15-18-1-21(a) (2013). 134 ind. state bd. of animal health, supra note 1, at 7. 2014 423 indiana health law review non-paying guest from consuming raw milk produced by a cow that the farmer owned.135 as explained above, there are several different ways that a state can regulate the sale of raw milk. like many other states, in the face of this growing raw milk debate, indiana is currently taking a second look at its longstanding policy of prohibiting the sale of raw milk to consumers. the 2012 indiana general assembly, faced with some bills that would potentially affect raw milk regulation, passed house enrolled act 1129 (hea 1129). this act directed the indiana boah to delve deeper into the contentious issue of raw milk regulation. the act directed boah to write and deliver a report to the general assembly about the issue no later than december 1, 2012.136 the report included not only whether boah believed raw milk sales should be made legal but it also covered the most effective methods for doing so. even though indiana has a very clear statute mandating the pasteurization of all milk sold for human consumption, as in other states, some indiana residents who want to consume raw milk have circumvented this law, or in some cases, deliberately violated it. the boah report indicates that there are several ways that indiana residents are gaining access to raw milk. some residents are deliberately violating the statute by purchasing raw milk from farmers. some residents are purchasing raw milk designated as pet food for personal consumption. in fact, the office of the indiana state chemist (oisc), which regulates commercial feed in indiana, has noted that recently there has been an increase in the number of farmers applying for a license to sell raw milk as pet food.137 the oisc has also noticed that more farmers are selling raw milk, labeled as pet food, at retail stores and farmers markets. this milk may often be sold with literature indicating that humans should consume raw milk.138 in response to this increase in the sale of raw milk labeled as pet food, in 2012 the indiana general 135 id. at 8. 136 id. at 5. 137 id. at 16. 138 id. 424 vol. 11:1 striking a balance: regulation of raw milk assembly amended indiana code section 15-19-7-40 to require all raw milk sold as pet food to have a conspicuous label stating "not for human consumption." the amendment also makes it illegal to promote or advertise raw milk as being fit for human consumption. 139 the boah report further indicates that cow-shares, or herd-shares, are presently used in indiana as a way to circumvent the prohibition on the sale of raw milk. unlike other states that have directly dealt with the presence of cow-shares, indiana has no law or regulation directly addressing cow-shares. also, the issue of cow-shares has not been litigated in any indiana court. while indiana government officials are fully aware that cow-shares are being used to distribute raw milk, as of yet the government has not taken any explicit step to allow or prohibit them. 140 the final method of obtaining raw milk that the boah report mentions is distribution agreements. these include community supported agriculture (csa) programs where individuals buy a subscription to receive a set quantity of food produced at a farm, and buying clubs where individuals buy products directly from the farm.141 one of the primary reasons stated by raw milk advocates for why the distribution agreements do not violate indiana law is that because the programs are only open to members, and not the public, the indiana pasteurization regulations do not apply. 142 the board of animal health report next addresses the issue of farm owner's insurance. 143 since farmers can be found liable for tainted food produced on the farm, the boah was interested in finding out if any of the top farm owner's insurance companies had an exclusion policy for raw milk incidents. an exclusion policy would limit the insurance company's duty to cover for the farmer's liability if the illness was caused by consumption of raw milk. the question is an important one because if a farmer sold raw 139 id. 140 id. at 17. 141 id. 142 id. 143 id. at 18. 2014 425 indiana health law review milk that caused people to become seriously ill, an exclusion policy would leave the farmer on the hook for compensating the victims, possibly driving the farm out of business. worse, if the farmer could not fully compensate the victims, then the victims could be left without anyone else from whom they might recover. after looking at the top five farm owner's insurance companies operating in indiana, the boah report noted that the top insurance company and the bottom insurance company did have exclusion policies for raw milk consumption incidents, but the three in-between did not. 144 to obtain a good overall synopsis of how others approach the issue of raw milk regulation, the boah compiled regulation information from several other states and also from countries around the world. the boah report finds that including indiana, twenty states do not allow the sale of raw milk to consumers, while thirty states allow some form of selling raw milk.145 among the thirty states that do allow some form of raw milk sales, there is no overarching standard or regulation that all of the states use; however, virtually all of the thirty states do have some sort of regulatory system in place addressing the production and sale of raw milk.146 the large majority of states that do allow raw milk sales prohibit resale of the milk, and they also do not allow raw milk to be served in restaurants, hotels, schools, and health care facilities.147 of the thirty states, eighteen do not allow raw milk sales anywhere except on the farm where the milk was produced. of those eighteen states, most placed further restrictions on the sales. four of the states only allowed raw goat milk to be sold.148 this is due to the fact that goats tend to be cleaner than cows, and therefore goat milk is less likely to be contaminated with harmful pathogens. four states only allowed "incidental" sales (the boah report does not define the word "incidental," but the 144 id. 145 id. at 19. 146 id. 147 id. 148 id. 426 vol. 11:1 striking a balance: regulation of raw milk merriam-webster dictionary defines it as "occurring merely by chance or without intention or calculation.").149 a small number of the states actually allow the farmer to directly deliver the raw milk to the consumer. 150 a little fewer than half of the thirty states allow raw milk to be sold at farmers markets and at retail stores. however, some states limit those sales to retail stores owned by the farmer, or they only allow the sale of raw goat milk at the farmers' market. 5 1 while some states directly address cow-shares or herdshares, the majority of states, like indiana, have not. of those that have addressed them, approximately half of them have continued to allow raw milk to be distributed through the shares, and the other half of the states do not allow cowshares unless the milk is pasteurized. 152 also, in the states that allow some form of raw milk sales, most only allow the sale of milk andlor cream, but not other dairy products such as butter or yogurt. only a small number of states have a limit on the number of cows or goats that can be milked or on how much milk can be sold at a time.153 of the thirty states that allow raw milk sales to consumers, almost all of them require the raw milk producer to be licensed with the state and undergo regular sanitation testing to reduce the chance of raw milk being contaminated with pathogens. 154 there are several areas in the milk producing process where the states usually set standards and regularly do testing. typically, statewide standards must be met for cow health, the cleanliness of the area where the cows are milked, the cleanliness of the milking equipment used, cooling temperatures and storage of the milk, construction and sanitation of the dairy farm as a whole, the containers and filling methods, and labeling of the milk. the quality of the actual milk can also be tested 149 incidental definition, merriam-webster, http://www.merriamwebster.com/dictionary/incidental (last visited sept. 8, 2013). 150 ind. state bd. of animal health, supra note 1, at 19. 151 id. 152 id. at 20. 153 id. 154 id. 2014 427 indiana health law review for the somatic cell count, bacteria, coliform, pathogens, and drug residues. 155 being aware of the raw milk regulations used in other states and looking at what has and has not worked in those other states can be invaluable as a way to devise new standards for indiana. because states are situated similarly in relation to the federal government, it can be relatively easy to take ideas from other states and adopt them for use in indiana. nevertheless, because the states have been taking ideas almost exclusively from each other and applying standards that have been used in other states, it is likely that other countries have adopted raw milk regulations that are entirely new and unseen in the united states. for this reason, the raw milk regulations in other countries should be analyzed to see if any new ideas can be gleaned from them. the boah did not complete an in-depth analysis on the pasteurization laws of other countries, although it did gather some basic information from a few countries. 56 canada, for example, entirely prohibits raw milk sales to consumers. the boah noted that the european union allowed its member states to keep or introduce their own laws on raw milk sales. the united kingdom revisited its raw milk policies a few times between 1997 and 2002, but in the end it decided to leave the policy as it was.15 7 raw milk can be sold to consumers on the farm or at farmers' markets, or a delivery person can deliver the milk. retail sales are not allowed. raw milk dairies must be licensed and continue to meet sanitation and warning label requirements.158 in 1983, scotland prohibited raw cow milk from being sold for human consumption, and it extended that prohibition to all raw milk in 2006.159 italy has one of the more unusual approaches to raw milk regulation of the countries looked at by the boah. in 155 i[d. 156 id. at 21. 157 i[d. 158 id. 159 id. 428 vol. 11:1 striking a balance: regulation of raw milk italy, "local officials in territories" can sell raw milk.160 also, raw milk can be sold in vending machines.161 finally, germany allows raw milk to be sold on the farm where it was produced. vending machine sales and off-the-farm sales are also allowed, however these sales are regulated more strictly.162 in the conclusion of the report, the boah notes that "[bloth sides of the raw milk debate have sincere deeply held positions on the issue. no consensus middle ground exists between the public health community that wants no raw milk sales to consumers and advocates who want raw milk sales to consumers."163 the report goes on to say that pasteurization of milk has been an effective way to make milk safer, and allowing raw milk sales would undoubtedly increase the possibility of indiana residents becoming ill from pathogens in the milk. however, the report reminds the reader that although there are twenty states that prohibit the sale of raw milk, there are thirty states, or 60% of the states, that have decided that the benefits outweigh the risks of allowing sales of raw milk.164 at the end of the report, the boah recommends that the indiana general assembly take one of two distinct approaches. in "option a," the boah recommends that indiana: [m]aintain the current requirement for milk to be pasteurized prior to sale and amend the statute to clarify that all persons producing milk for consumption must comply with state sanitation standards and pasteurize the milk regardless of the method used to distribute the milk, including cow or herd share arrangements and products labeled for pet food. 165 160 id. 161 id. 162 id. at 22. 163 id. 164 id. 165 id. at 23. 2014 429 indiana health law review this "option a" approach would effectively close all loopholes for selling raw milk that currently exist, making indiana one of only 12 states that do not allow sales of raw milk for consumption in any form. 166 practically speaking, the only individuals able to obtain raw milk would be the dairy farmer, his family, and any friends or occasional guests that the farmer would give raw milk to for free. the boah's "option b" goes in the opposite direction. option b calls for changing current legislation in order to "allow limited distribution of raw milk directly from the farmer producing the milk to consumers and authorize the boah to establish minimum sanitary requirements that may reduce the risk of human illness."167 following this approach would place indiana with 15 other states that have decided to allow sales of raw milk confined to the farm.168 the boah then goes on to say that if option b is adopted by the general assembly, certain basic principles should apply. first, they say, the boah should be given the authority to adopt rules that would require raw milk permits and set sanitation standards to be followed by the raw milk producers.'6 9 next, the boah states that all raw milk farmers should be held to the same standards.170 finally, all raw milk that is sold needs to be sold directly to consumers by the farmer from whose farm the milk came.171 along with these basic principles, the boah set out in appendix b of the report further ideas of what allowing the sale of raw milk could look like and what issues would need to be addressed if raw milk sales were legalized by the general assembly. for example, the committee making the recommendations was split on what locations raw milk sales should be allowed. while everyone on the committee agreed that raw milk could be sold on a farm where it is produced, there was disagreement as to whether a farmer 166 state by state review ofraw milk laws, supra note 103. 167 ind. state bd. of animal health, supra note 1, at 23. 168 state by state review ofra w milk laws, supra note 103. 169 ind. state bd. of animal health, supra note 1, at 23. 170 id. 171 id. 430 vol. 11:1 striking a balance: regulation of raw milk could deliver the milk to consumers, and whether a farmer could sell the raw milk at a farmers' market or at a retail store owned and run by that farmer.172 the boah committee also reviewed the loopholes that allow for raw milk sales, such as pet food sales and cowshares. the committee did not make a recommendation on whether those loopholes should be closed or not. however, if those loopholes did continue to exist, the cowshare and pet food distributors would be held to the exact same standard as farmers who sell raw milk directly to consumers.173 in order to determine who would be allowed to sell raw milk, the boah would issue a "raw milk products permit," similar to the other milk permits that boah currently issues. in order to obtain this permit, the farmer would have to comply with certain requirements set forth by boah.174 interestingly enough, the raw milk products permit would allow raw milk from any hooved mammal to be sold, including "cattle, water buffalo, sheep, goats, camels, deer, and horses."175 other topics that would need to be addressed in greater specificity by boah are recall plans in case tainted raw milk is discovered, standards that farmers must comply with in producing, bottling, and storing raw milk, labeling requirements, somatic cell count and bacteria standards, testing for animal health and farm sanitation, and record keeping.176 in response to the boah report, on january 14, 2013, indiana senator richard young, a democrat, introduced senate bill 513.177 this bill set out the necessary framework for allowing raw milk sales in indiana and 172 ind. state bd. of animal health, indiana state board of animal health report on the issue of selling unpasteurized milk to consumers: boah recommendations app. b (2012), available at http://www.in.govboah/files/boahrawmilkreport_(2012)_fullr eport.pdf. 173 id. at 3-4. 174 id. at 5. 175 id. 176 id. at 6-11. 177 s.b. 513, 118th gen. assemb., 1st reg. sess. (ind. 2013), availableathttp://openstates.org/in/bills/2013/sb513/. 2014 431 indiana health law review mirrored very closely the recommendations outlined in the boah report. the bill would allow raw milk sales if the sellers met certain requirements. these requirements would be determined by the boah. further, the bill would completely prohibit "reselling or redistributing raw milk, or offering, providing, or distributing raw milk in a restaurant, educational institution, day care facility, or health care facility."178 the state chemist would continue to be in charge of regulating raw milk sold as pet food, but the chemist would also be responsible for making sure that the raw milk pet food also met the boah criteria for raw milk intended for human consumption. however, the indiana senate was never given the opportunity for a vote on sb 513 as it later died in the committee on agriculture and natural resources.' 79 three days after sb 513 was introduced, senate bill 610 was introduced by two indiana senate republicans, john waterman and jim banks.180 sb 610 would have allowed the "acquisition of unpasteurized milk by an individual who obtains the milk from animals solely or partially owned by the individual."181 the bill would also have allowed raw milk dairy farmers to give their raw milk to family members and nonpaying guests. so while passage of sb 513 would have been the ultimate prize for raw milk advocates, passage of sb 610 would at least ensure that cow-shares would continue to exist in indiana, whether direct sales were legal or not. passage of sb 610, without the simultaneous passage of sb 513, would have made indiana only the fourth state to pass a statute or regulation explicitly allowing the existence of cow-shares as a means to distribute raw milk.182 as it turned out, however, sb 610 was eventually allowed to die in the committee on health 178 id. 179 dan flynn, raw milk study leads indiana to keep mandatory pasteurization, food safety news (mar. 6, 2013), http://www.foodsafetynews.com/2013/03/indianafollows/#.uts7tbyg3uu. 180 s.b. 610, 118th gen. assemb., 1st reg. sess. (ind. 2013), available athttp://openstates.org/in/bills/2013/sb610/. 181 id. 182 state by state review of raw milk laws, supra note 103. vol. 11: 1432 striking a balance: regulation of raw milk and provider services, leaving any hopes for quick progress on raw milk access to die with it.183 while these recent setbacks certainly provide a blow to the raw milk movement in indiana, raw milk advocates can take some comfort in the fact that the result was not worse. the boah report offered two options with polar opposite results, one option to allow some sales of raw milk, and one option to prohibit all sales and close all the current loopholes. so even though the bill attempting to allow raw milk sales did not succeed, as of now, no bill has been introduced that would attempt to close all the loopholes. with the failure of both pro-raw milk bills to even make it out of committee, it would not be hard to imagine that a bill proposing to close all the loopholes would enjoy strong support in the indiana senate and might even leave raw milk advocates empty-handed. iv. conclusion as shown, there are innumerable factors to consider when addressing the issue of raw milk sales. however, the decision that a state makes ends up being simply a matter of policy reached by balancing the pros and cons of each side. as the indiana general assembly is considering this issue in light of the boah report, it is apparent that there are three broad options that the general assembly could take. it could close the loopholes and completely prohibit raw milk sales. it could leave the current regulations untouched, leaving the loopholes open for individuals to exploit. finally, it could loosen the current prohibitions and allow at least some sales of raw milk. by deciding to change current regulations to allow sales of raw milk, the general assembly would appropriately be promoting a policy that values consumer choice and the ability of individuals to determine what is best for his or her own needs. as food and health choices are very personal, giving consumers the chance to choose the foods that promote health and well-being should be an important 183 flynn, supra note 179. 4332014 indiana health law review objective of the general assembly. as shown by the boah report's analysis of "option b," and shown by the many states that currently allow some form of raw milk sales, it would not be difficult to establish a regulatory framework for allowing sales from certified raw milk producers. indiana's boah is already responsible for certifying and distributing licenses for dairy farmers, so the infrastructure to certify raw milk producers is in place. also, as other states have set up certification processes for raw milk dairies, the general assembly could pick and choose from regulatory policies that have worked in other states. another reason that the benefits of allowing raw milk sales outweigh the negatives is because of the scope of health dangers versus the potential health benefits. with an average of only fifty-four reported illnesses attributed to raw milk consumption each year, and no deaths since 1998, raw milk consumption is simply not a significant public health concern.184 this is especially true in light of the average of 600 illnesses from pasteurized milk185 and the seventy-six million cases of foodborne illnesses each year. 8 6 it is probable that the average number of illnesses attributed to raw milk consumption would rise if raw milk sales were allowed in indiana; however, because the number of individuals switching over from drinking pasteurized milk to raw milk would probably not be significant, the increased number of illnesses would most likely be negligible. while it is important to remember that raw milk consumption could lead .to serious illness, or potentially even death, this may be the case with any food product, as demonstrated by the sicknesses caused by the pasteurized milk outbreaks and the recent outbreak of salmonella in cantaloupe.187 it is worth noting that according to outbreak data from the cdc, the risk of getting 184 rencher, supra note 47, at 421; gumpert, supra note 60. 18 rencher, supra note 47, at 422. 186 id. at 421. 187 james andrews, cantaloupe outbreak: some retailers identified, others not, food safety news (aug. 25, 2012), http://www.foodsafetynews.com/2012/08/cantaloupe-outbreak-someretailers-identified-others-not/#.utjkwbyg3uu. 434 vol. 11:1 striking a balance: regulation of raw milk sick from eating deli meat, a food common in any supermarket, is higher than the risk of drinking raw milk.188 on the other hand, to many people, the potential health benefits of drinking raw milk outweigh the possible risks. while the nutritional superiority of raw milk is questioned by government health agencies, the government agencies fail to take into consideration the countless number of raw milk testimonials presented as anecdotal evidence of raw milk's health benefits. whether the raw milk being consumed by these individuals is truly benefitting them or is merely having a placebo effect, it would be irresponsible for the government health agencies to ignore this evidence. further, the 2005 european study and 2011 gabriella study showing lower levels of asthma and allergies in children who drink raw milk lend even more credence to the raw milk testimonials.1 8 9 while a few states, such as california, washington, and pennsylvania allow the sale of raw milk in retail stores, the majority of states that allow raw milk sales have not gone as far. in the boah report's recommendations on potential regulations, it is clear that if indiana were to allow the sale of raw milk, general retail sales would wisely not be an option. by allowing the sale of raw milk in a few specific areas, such as farms, farmers' markets, and stores owned and run by farmers, and keeping it out of most other retail stores, the state would be ensuring that unaware, unsuspecting consumers would not accidently purchase raw milk. if a consumer is forced to go to a farm, farmers' market, or farmer-owned store for milk, then it is much more likely that the consumer will be better informed about the risks involved with drinking milk and will have intentionally chosen to take their chances with raw milk. it would be unlikely that someone unaware of the risks of raw milk consumption would travel to one of these three types of locations and pick up raw milk. therefore, even though the risks are still present, the raw milk consumer is making a 188 gumpert, supra note 7, at 122. 189 byrne, supra note 11, at 116-17; loss et al., supra note 68. 4352014 indiana health law review conscious choice to face the possible ramifications of his decision to drink raw milk. as is the case in most of the other states that allow some form of raw milk sales, labels clearly marking the milk as "raw milk" should be mandated in most circumstances. it also may be required for the labels to generally state the possible risks of consuming raw milk. requiring these labels on raw milk in farmers' markets or farmer-owned stores would help ensure that every person purchasing the raw milk is aware of the risks. while the legislature may also mandate these labels on raw milk that is sold on farms, the likelihood that someone would drive to a farm and purchase raw milk without being informed of the risks is low enough as to render the labels essentially useless. another reason for the indiana general assembly to allow the sale of raw milk is that even if the general assembly leaves the regulations in their current state with the loopholes, or even decides to close the loopholes, raw milk advocates will continue to find ways to drink raw milk, even if it means directly violating the law. it would be better for the general assembly to allow raw milk sales and to closely regulate raw milk production and sales, thereby ensuring sanitary conditions, because the alternative would be to allow consumers to obtain raw milk from uncertified, and often unsanitary dairy farms. as brought up by raw milk advocates, several of the individuals who have become sick from drinking raw milk obtained their milk from conventional dairies that send most of their milk to be pasteurized. because this milk was produced with pasteurization in mind, the dairies might not have maintained as strict of sanitation standards. 19 0 by allowing raw milk sales and setting up a raw milk certification procedure, indiana could ensure that raw milk dairies are producing milk under sanitary conditions that lessen the likelihood of the milk being contaminated. although there will always be some risks in drinking raw milk, it is helpful to remember that the pressing need for pasteurization was only apparent once the rapidly 190 gumpert, supra note 7, at 117. 436 vol. 11:1 striking a balance: regulation of raw milk deteriorating and unsanitary conditions of dairy farms in the city caused the milk to be laden with deadly diseases such as tuberculosis.191 based on evidence from other states that have established a certification process to allow the sale of raw milk, raw milk sales in those states have not resulted in a widespread epidemic of illnesses like was the case during the early 1900s when the sanitary conditions of the cows were poor. even though actual statistics show that raw milk consumption is not as much of a public health risk as originally believed, it is understandable that the general assembly might be hesitant to allow the sale of a product that was responsible for thousands of deaths in the early 1900s. for this reason, the general assembly may decide that it would be best to allow a trial run before completely allowing raw milk sales. for example, the general assembly could initially allow the boah to issue only a very limited number of raw milk certifications in order to keep potential outbreaks smaller and more confined. the general assembly could also require that the issue be addressed again in three or five years, after which the general assembly could reevaluate whether it wants to continue to allow raw milk sales. although the vast majority of milk consumed by individuals in the united states since the early 20th century has been pasteurized, the strong demand for raw milk and the possible health benefits it could bring, as compared with the minor risk of illness caused by the raw milk, tip the scales in favor of legalizing the sale of raw milk. through careful regulation by indiana's board of animal health, raw milk dairy farms can sell a natural food that produces a minimal chance of making someone sick from the pathogens in the milk. as indiana already has a dairy certification process in place, the start-up costs of creating a raw milk certification would be minimal. although the few potential risks of drinking raw milk can be serious, placing the choice to drink raw milk in the hands of consumers is a good way to put health back in the hands of the people of indiana. 191 byrne, supra note 11, at 127; gumpert, supra note 7, at xxv. 4372014 microsoft word final for lulu vol. 14 issue 1 final a. development of the responsible corporate officer doctrine b. who is responsible under the responsible corporate officer doctrine and who else should be held responsible? c. industries most affected by the responsible corporate officer doctrine d. defenses to responsible corporate officer doctrine e. civil remedies of exclusion 1. exclusions of individuals by the oig 2. exclusion of entities by doj oxycontin sales personnel, misbranding and inadequate compliance program the trio’s defenses others involved in the oxycontine and the illicit drug scandal the trio’s plea deal considering and accepting the trio’s guilty plea rcod resulting in exclusion does not violate due process conflict of interest and indemnification http://doi.org/10.18060/3911.0032 oig is focused on holding responsible corporate officials accountable for healthcare fraud see united states v. esformes et al. the economic case for healthcare reform hhs fy2015 budget in brief , the $272 billion swindle: why thieves love america’s health-care system oig most wanted fugitives criminally per se or id. the responsible corporate officer doctrine, a re-emergent threat to general counsel and corporate officers circumscribing the “prosecutor’s ticket to tag the elite”: a critique of the responsible corporate officer doctrine a bitter pill for the pharmaceutical industry? hhs-oig's enforcement of the responsible corporate officer doctrine, feds now target execs, not just companies, in health frauds supra supra misconduct . “ civil criminally even if purdue frederick company more about the responsible corporate officer doctrine supra see also rev'd , history the department of health and human services and the department of justice health care fraud and abuse program annual report for fy 2000 hhs agencies and offices about doj improving efforts to combat healthcare fraud: hearing before the comm. on ways and means, subcomm. on oversight id. id. id. id. supra hhs historical highlights supra japanese and american privacy laws, comparative analysis supra see also improving efforts to combat healthcare fraud: hearing before the comm. on ways and means, subcomm. on oversight supra the effect of exclusion from participation in federal health care programs supra supra id id hospital chain will pay over $513 million for defrauding the united states and making illegal payments in exchange for patient referrals; two subsidiaries agree to plead guilty, a. development of the responsible corporate officer doctrine balint balint dotterweich. dotterweich dotterweich, dotterweich united states v. park. park rcra and the responsible corporate officer doctrine: getting tough on corporate offenders by sidestepping the mens rea requirement, see also id. see dotterweich supra park becoming aware failed to correct park without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense see ee also ); ee also b. who is responsible under the responsible corporate officer doctrine and who else should be held responsible? rcod prima facie mens rea guidance for implementing permissive exclusion , supra corporate c. industries most affected by the responsible corporate officer doctrine not ill. hospital chain inks record $5.5m hipaa deal, florida hospital system agrees to pay the government $85 million to settle allegations of improper financial relationships with referring physicians, community health systems inc. to pay $98.15 million to resolve false claims act allegations, data breach results in $4.8 million hipaa settlements ocr announces initiative to more widely investigate breaches affecting fewer than 500 individuals, d. defenses to responsible corporate officer doctrine qui tam qui tam qui tams civil criminal halifax top ten health law issues, fraud and abuse enforcement, supra see medicare thief? tenet strikes again: serial offender offers $513m fca settlement id. see also, halifax not at the time quoting ., id. id. id. see practical guidance for health care governing boards on compliance oversight id. corporate integrity agreements, e. civil remedies of exclusion 1. exclusions of individuals by the oig a bitter pill for the pharmaceutical industry? hhs-oig's enforcement of the responsible corporate officer doctrine, the new oig “responsible corporate officer doctrine”, supra remarks at the american bar association’s 25th annual national institute on healthcare fraud u.s. v. park guidance for implementing permissive exclusion supra supra guidance for implementing permissive exclusion supra guidance for implementing permissive exclusion supra id. supra id. id. special advisory bulletin on the effect of exclusion from participation in federal healthcare programs purdue oxycontin ee infra exclusions faq, id. id. id. id. supra 2. exclusion of entities by doj . . . . id. , all stripes purdue purdue oxycontin purdue’s id supra rev'd friedman vs. sebelius: purdue executive exclusion upheld, but terms voided as arbitrary and capricious purdue a. oxycontin id. id. id. id. rev’d id. id. id. purdue says kentucky suit over oxycontin could be painful b. sales personnel, misbranding and inadequate compliance program supra id. see supra id. id. c. the trio’s defenses d. others involved in the oxycontin and the illicit drug scandal supra id. supra supra id. supra e. the trio’s plea deal fedex faces drug-trafficking charges, cardinal health blocked from shipping painkiller in florida id. id. id. id. id. supra the responsible corporate officer doctrine: defending individuals in fdca cases f. considering and accepting the trio’s guilty plea id. see also supra supra see g. rcod resulting in exclusion does not violate due process see, e.g. id. see id. exclusions faq supra does an exclusion affect a person’s right to receive benefits under the medicare, medicaid and all federal health care programs id. h. conflict of interest and indemnification will quid pro quo, id. supra , id. id. id. id. supra see also delaware court rules on director's entitlement to indemnification for expenses incurred in criminal suit, regulatory action and internal investigation, don't win the battle but lose the war retaining directors' mandatory indemnification rights in settlements of civil and criminal proceedings, indemnification clauses id. e.g. health information and data security safeguards see physicians post-ppaca: not going bust at the healthcare buffet united states v. park ., supra id. supra knowing supra compliance guidance id. id federal fraud enforcement and physician compliance, id. a guide to the rulemaking process doj’s important message to health system leadership id. see effective compliance and ethics programs under the amended sentencing guidelines supra . supra quoting quoting federal fraud enforcement and physician compliance, compliance program policy and guidance legal only if supra see supra drug dealing and the internal morality of medicine matt lamkin* introduction which practices qualify as “medical” in nature? this question has important legal implications. every state has laws prohibiting the “unauthorized practice of medicine.”1 health insurance policies generally limit coverage to procedures that are “medically necessary.”2 and physicians can be prosecuted as drug traffickers if they prescribe controlled substances without a “legitimate medical purpose.”3 each of these questions—and many others—hinge on how medicine is defined. as with many common terms, we all have a general understanding of what medicine is and this heuristic suffices to carry us through our daily lives without complication. yet when called on to produce a precise definition that captures all practices we think of as “medical,” while excluding those we do not, that task proves exceptionally challenging.4 this problem is further complicated by the fact that what qualifies as “medical” may vary across different contexts. prescribing botox to mitigate frown lines may qualify as a “medical” intervention for purposes of laws regulating doctors but may not qualify as “medically necessary” for purposes of insurance reimbursement. yet despite the difficulty of defining medicine and the weighty legal consequences that can hinge on these definitions, courts, regulators, and legal scholars have given little consideration to these challenges in the context of regulating physician prescribing. instead, they have often relied on “commonsense” definitions that fail to grapple with the complexity of the issue.5 as a result, legal standards that govern prescribing are often unclear and inconsistently applied, leaving physicians without a clear understanding of which conduct they must avoid.6 given multiple opportunities to resolve this issue definitively, the united states supreme court has repeatedly demurred, including most recently in its 2022 opinion in ruan v. united states.7 * associate professor, university of tulsa college of law. 1. glenn cohen, protecting patients with passports: medical tourism and the patientprotective argument, 95 iowa l. rev. 1467, 1540 (2010). 2. nat’l ass’n ins. comm’rs, understanding health care bills: what is medical necessity?, https://content.naic.org/sites/default/files/consumer-health-insurance-what-is-medicalnecessity.pdf [https://perma.cc/sf2y-hudh]. (last visited mar. 10, 2023) 3. 21 c.f.r. § 1306.04(a) (2020). 4. see peter h. schwartz, reframing the disease debate and defending biostatistical theory, 39 j. med. & phil. 572, 572-89 (2014) (critiquing attempts to use conceptual analysis to define concepts such as “health” and “disease”). 5. matt lamkin, legitimate medicine in the age of consumerism, 53 u.c. davis l. rev. 385, 392, 395 (2019). 6. id. at 385, 388, 392, 395, 397, 401, 435. 7. ruan v. united states, 142 s. ct. 2370 (2002). 62 indiana health law review [vol. 21:61 by contrast, philosophers of medical ethics have wrestled with the complexity of determining medicine’s proper scope for at least half a century.8 drawing on this more rigorous debate could help refine and clarify legal standards governing prescribing. however, such an effort would have to contend with the fact that the philosophical literature on this question is strikingly inconclusive. some prominent bioethicists contend medicine is defined by an “internal morality” that defines its scope. for example, some claim the essence of medical practice is healing, so that actions taken for other purposes, such as enhancing one’s physical appearance, do not qualify as medical in nature and are therefore improper for physicians to perform.9 others deny medicine’s scope is limited by any internal morality, instead insisting that judgments regarding the propriety of physicians’ conduct must be governed by considerations external to the practice of medicine.10 in this view, as long as cosmetic surgery is ethical in general (e.g., under universal moral principles), it is ethical for physicians to engage in that practice. there is no essential nature of medicine that physicians would transgress in so doing. happily, this debate need not be resolved in order for the law to benefit from it. rather than seeking to determine what medicine’s “true” nature is, it may be useful to examine the various conceptions offered by these observers and seek an account that is consonant with existing legal standards while also helping refine them. not every account of medicine’s proper scope is equally suitable for informing the legal standards governing prescribing. “internal” accounts that reject nontherapeutic practices as “non-medical” are flatly inconsistent with existing law, which countenances cosmetic surgery, vasectomies, and other nontherapeutic practices as within medicine’s ambit. conversely, external accounts that deny the existence of an internal morality of medicine without providing an alternative definition of medicine’s scope are of little use when specifying which acts doctors can lawfully perform. what is needed is a standard that is broadly consistent with existing legal standards, but that helps clarify them. an account of medicine’s scope offered by philosopher christopher boorse meets these criteria. although boorse takes no position regarding whether medicine is governed by an internal morality, he argues that if such a morality exists, it is a broad one.11 rather than limiting the practice of medicine to treating illnesses, in this view doctors can provide a wide range of interventions as long as they are seeking to use their expertise and skill 8. see, e.g., leon r. kass, regarding the end of medicine and the pursuit of health, 40 the pub. int. 11, 42 (1975). 9. see, e.g., edmund d. pellegrino, the internal morality of clinical medicine: a paradigm for the ethics of the helping and healing professions, 26 j. med. & phil. 559 (2001). 10. see, e.g., tom beauchamp, internal and external standards for medical morality, 26 j. med. & phil. 601 (2001); robert m. veatch, the impossibility of a morality internal to medicine, 26 j. med. & phil. 621 (2001). 11. christopher boorse, goals of medicine, in naturalism in the philosophy of health: issues and implications 163 (élodie giroux ed., 2016). 2024] drug dealing and the internal morality of medicine 63 to benefit the patient. at first blush, this standard may seem both too indeterminate and too permissive to inform legal questions regarding when a physician has prescribed without a “legitimate medical purpose.” in fact, however, boorse’s approach helps focus this inquiry and clarifies the kinds of evidence that support the conclusion that a doctor has abused their prescribing authority. in particular, rather than asking whether a doctor prescribed “too much” of a painkiller or negligently allowed patients to divert their medications, claims that a physician violated federal prescribing laws should focus on the doctor’s motivations.12 while a physician can face a range of legal consequences for harmful prescribing practices, such as loss of license and civil liability, not every bad doctor is a drug trafficker. as long as the physician was seeking to benefit the patient, rather than seeking to profit from dispensing drugs without regard for the patient’s wellbeing, the doctor should be deemed to have acted with a “legitimate medical purpose” under federal drug laws. of course, just because a particular account of medicine’s scope is well suited to resolving certain legal questions does not mean it is the best account of what is ethical for doctors to do. the law merely sets a floor of minimally acceptable conduct, not an ethical standard to which every doctor should strive. there may be many practices that should not be punishable by criminal law but may still be condemned as unethical for doctors to perform. a different account of medicine’s proper scope may be better suited to resolving bioethical controversies. but criminal liability for transgressing medicine’s proper bounds should be limited to narrow and clearly defined circumstances. i. federal law governing physician prescribing lacks a coherent account of medicine’s scope the federal government regulates the manufacture, sale, and possession of many drugs through the controlled substances act (csa).13 to prevent “the diversion of drugs from legitimate to illicit channels,” the act controls who may prescribe drugs and for which purposes.14 the act provides that many drugs can only be dispensed pursuant to a prescription issued by a “practitioner,” meaning a physician or other person who is legally permitted to dispense a controlled substance “in the course of professional practice or research.”15 regulations 12. diane e. hoffmann, treating pain v. reducing drug diversion and abuse: recalibrating the balance in our drug control laws and policies, 1 st. louis u. j. health l. & pol’y 231, 306 (2016). 13. 21 u.s.c.a. § 812. 14. gonzales v. raich, 545 u.s. 1, 12-13 (2005). 15. 21 u.s.c.a. § 802(21) (westlaw through pub. l. no. 118-13) (defining “practitioner”); 21 u.s.c.a. § 829(a)-(b) (westlaw through pub. l. no. 118-13) (authorizing “practitioner[s]” to prescribe controlled substances); united states v. rosenberg, 515 f.2d 190, 193 (9th cir. 1975); see 21 u.s.c.a. § 841(a)(1) (westlaw through pub. l. no. 118-13) (criminalizing distribution of 64 indiana health law review [vol. 21:61 promulgated by the drug enforcement administration (dea) provide that a prescription is valid only if it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”16 if a physician prescribes a drug without a legitimate medical purpose, she is deemed not to have acted as a “practitioner,” and has therefore violated the act’s provisions that prohibit non-practitioners from dispensing controlled substances.17 in other words, under these circumstances the doctor has ceased to act as doctor and has instead acted as a drug trafficker. accordingly, whether a prescription has a “legitimate medical purpose” carries significant legal consequences for a physician. yet the controlled substances act does not define the phrase “legitimate medical purpose” or “the usual course of professional practice.” nor have courts, prosecutors, or the dea supplied useful definitions of these concepts. indeed, in 2006 the dea released a policy statement insisting that “it is not possible to expand on the phrase ‘legitimate medical purpose in the usual course of professional practice,’ in a way that will provide definitive guidelines that address all the varied situations physicians might encounter.” the agency further declared that “one cannot provide an exhaustive and foolproof list of ‘dos and don’ts’ when it comes to prescribing controlled substances for pain or any other medical purpose.”18 courts have fared no better. in one early case, a court stated with apparent confidence that the phrase “‘in the course of professional practice’ . . . clearly means that a doctor is not exempt from the statute when he takes actions that he does not in good faith believe are for legitimate medical purposes.”19 despite the vacuousness of this “definition,” the court insisted “it is difficult to see how the language can be made more precise and at the same time ban the undesirable conduct on the part of physicians which congress intended to make illegal and subject to sanctions.”20 in a more recent case, a court concluded that no “specific set of facts had to be present in order to find that a physician stepped outside of his role and issued prescriptions without a legitimate medical purpose.”21 rather, to convict a physician as a drug trafficker, courts simply “looked to the facts in the record to controlled substances “[e]xcept as authorized by this subchapter”). 16. 21 c.f.r. § 1306.04(a) (2020). 17. rosenberg, 515 f.2d at 193 (“[a] doctor who acts other than in the course of professional practice is not a practitioner under the act and is therefore not authorized to prescribe controlled substances. such a physician is therefore subject to the criminal provisions of the act contained in section 841(a)(1).”). 18. dispensing controlled substances for the treatment of pain, 71 fed. reg. 52,716, 52,717, 52,719 (sept. 6, 2006) https://www.federalregister.gov/documents/2006/09/06/e614517/dispensing-controlled-substances-for-the-treatment-of-pain [https://perma.cc/kbr6-lrsl]. 19. rosenberg, 515 f.2d at 197. 20. id. at 198; id. at 204 (ely, j., dissenting) (concluding that “congress has, without doubt, used language that is ‘. . . so vague that men of common intelligence must necessarily guess as to its meaning and differ as to its application.’”). 21. united states v. mackay, 715 f.3d 807, 823 (10th cir. 2013). 2024] drug dealing and the internal morality of medicine 65 conclude enough facts existed for a fact finder to affirmatively determine that the physician issued the drugs for an improper purpose.”22 this analysis, such as it is, seems to amount to little more than “we know it when we see it.” it is useless to physicians in determining what conduct they must avoid in order to comply with the law. the united states supreme court has repeatedly declined opportunities to bring clarity to this issue. in gonzales v. oregon, the state of oregon challenged the united states attorney general’s threat to revoke the prescribing privileges of physicians who prescribed lethal drugs to certain terminally ill patients at their request, in compliance with the state’s death with dignity act.23 the federal government argued hastening a patient’s death was not a legitimate medical purpose, so prescribing drugs for that purpose violated the controlled substances act. although the court rejected the government’s argument, it sidestepped the question of how to define the legitimate scope of medical practice. instead, the court simply concluded that since committing suicide was not the kind of “drug abuse” the act aimed to combat, prescribing drugs for that purpose did not violate the law.24 while this reasoning was sufficient to resolve the case, it did little to clarify the scope of legitimate prescribing outside the context of assisted suicide. in the absence of a clear definition, courts have applied radically different standards to determine whether a physician prescribed drugs without a legitimate medical purpose. several courts have insisted that physicians can only be convicted under the act if they act outside the course of professional practice by intentionally acting as a drug dealer.25 as one court explained, “[a] practitioner becomes a criminal not when he is a bad or negligent physician, but when he ceases to be a physician at all.”26 however, as the federal government has cracked down on physician prescribing in response to the opioid epidemic, prosecutions have ensnared 22. id., see also united states v. august, 984 f.2d 705, 713 (6th cir. 1992) (“there are no specific guidelines concerning what is required to support a conclusion that an accused acted outside the usual course of professional practice. rather, the courts must engage in a case-by-case analysis of evidence to determine whether a reasonable inference of guilt may be drawn from specific facts.”). 23. gonzales v. oregon, 546 u.s. 243 (2006); or. rev. stat. ann. § 127.800 et seq. (west 2003). 24. gonzales, 546 u.s. 243, 273-74. 25. see, e.g., united states v. feingold, 454 f.3d 1001, 1007-08 (9th cir. 2006) (“we agree with dr. feingold’s contention that a practitioner who acts outside the usual course of professional practice may be convicted under § 841(a) only if he does so intentionally. . . . simply put, to convict a practitioner under § 841(a), the government must prove . . . that the practitioner acted with intent to distribute the drugs and with intent to distribute them outside the course of professional practice. in other words, the jury must make a finding of intent not merely with respect to distribution, but also with respect to the doctor’s intent to act as a pusher rather than a medical professional.”). 26. id. at 1011 (emphasis in original). 66 indiana health law review [vol. 21:61 physicians who may have over-prescribed medications, but who seemed to be trying to treat patients with genuine ailments.27 rather than requiring prosecutors to show that these physicians intentionally distributed drugs with no legitimate purpose, several courts have allowed juries “to convict based on an ex post facto ‘he should have been more careful’ theory or to convict on mere negligence.”28 these conflicting standards reached the supreme court in 2022 in ruan v. united states. in hearing appeals by physicians who were convicted for violating the csa by writing improper prescriptions, the court rejected the idea that doctors could violate the act simply by prescribing in ways that do not conform to common practices.29 instead, the court held that “the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”30 in reaching this conclusion, the court emphasized that the requirement that prescriptions must have a “legitimate medical purpose” was “‘ambiguous,’ written in “generalit[ies], susceptible to more precise definition and open to varying construction.’”31 yet the court did not attempt to resolve this ambiguity by supplying a more precise definition of the conduct physicians must avoid. although the court held that prosecutors must show that an accused doctor “knowingly or intentionally acted in an unauthorized manner,” it made no attempt to specify which conduct is “unauthorized” under the act.32 thus, while ruan settled a circuit split regarding the government’s burden of proof when prosecuting doctors under the csa, the opinion did little to clarify what a doctor must do to act outside of (or remain within) the legitimate scope of professional practice. bringing clarity to that question would benefit physicians, courts, and regulators alike. ii. the bioethics debate can inform and clarify legal standards although courts have failed to acknowledge the complexity of defining medicine’s scope, philosophers have debated the issue for decades. the question of what qualifies as “medical” underlies bioethics debates regarding the propriety of physicians helping patients commit suicide, performing nontherapeutic abortions, and providing cosmetic surgery.33 some have argued it is unethical for physicians to engage in these practices, even if it would be ethical for others to perform these same acts, because medical practice is limited to promoting patients’ health. others claim that if the acts themselves are ethical, it is permissible for physicians to perform them. 27. see hoffmann, supra note 12. 28. id. at 305. 29. ruan v. united states, 142 s. ct. 2370, 2376 (2022). 30. id. (emphasis added). 31. id. at 2377, 2382. 32. id. at 2377. 33. john d. arras, a method in search of a purpose: the internal morality of medicine, 26 j. med. & phil. 643, 650 (2001). 2024] drug dealing and the internal morality of medicine 67 the fact that “equally perceptive observers of the medical scene could have come to such diametrically opposed conclusions about the most fundamental methodological question in medical ethics” reveals the true complexity of the issue.34 yet despite the “near-total disagreement about the existence and scope” of an internal morality of medicine,35 the bioethics literature can still be useful in informing legal questions regarding medicine’s scope. that task entails identifying a standard that is generally consistent with existing legal standards and practices but offers a definition of medical practice that is clearer and more coherent. a. narrow essentialism proponents of an internal morality of medicine claim “the nature of medicine, its internal goods and virtues, are defined by the ends of medicine itself, and therefore, ontologically internal from the outset.”36 in this view, certain acts are improper for doctors to perform in their professional capacity because they do not qualify as “medical” in nature, regardless of whether those practices would be wrong for non-medical professionals to perform. a prominent advocate of this view, edmund pellegrino, argues the ethics of medical professions “has its source in the nature of these professions, in what is distinctive about them and the good at which they aim.”37 specifically, he claims the good at which medicine aims is healing, arguing that “[m]edicine exists because being ill and being healed are universal human experiences, not because society has created medicine as a practice.”38 pellegrino’s central claim is that practices that do not aim at “the return of physiological function of mind and body” or “the relief of pain and suffering” are not truly “medical” in nature, and are therefore outside the scope of legitimate medical practice.39 in this view, while considerations external to medicine may constrain physician conduct (e.g., a physician cannot heal a patient against her will), those considerations cannot justify the physician performing, in her professional capacity, acts that do not aim at healing. for purposes of specifying when a prescription has a legitimate medical purpose, this approach has the benefit of offering a clear standard. in this view, practices that do not promote healing are not medical in nature. accordingly, a physician who prescribes drugs for any purpose other than promoting healing has ceased to act as a physician. 34. id. at 644. 35. boorse, supra note 11, at 152. 36. pellegrino, supra note 9, at 563. 37. id. at 560. 38. id. at 563; leon r. kass, toward a more natural science: biology and human affairs, 198 (the free press, 1985) (offering a similar essentialist account: “medicine violates the body only to heal it.”) 39. pellegrino, supra note 9, at 569. 68 indiana health law review [vol. 21:61 but while this approach has the benefit of clarity, it is unhelpful in setting a legal standard governing prescribing because it would condemn practices that are clearly legal and commonly performed by physicians. under this standard, prescribing drugs for purposes of contraception or erasing frown lines would be outside medicine’s scope when they are not aimed at treating or preventing any illness. given the ubiquity of such interventions, it seems clear such practices fall squarely within “the usual course of professional practice” under federal prescribing laws. as this legal standard suggests, it is derived from physicians’ customary practices, rather than from any abstract notions regarding medicine’s essential nature. indeed, the united states supreme court rejected this narrow essentialist standard in gonzales.40 in that case, the federal government argued that assisting suicide is not a legitimate medical purpose because it does not aim to promote patients’ health: the ordinary meaning of the term “medical” is “[p]ertaining or related to the healing art or . . . to ‘medicine,’” and the term “medicine” refers to “[t]hat department of knowledge and practice which is concerned with the cure, alleviation, and prevention of disease in human beings, and with the restoration and preservation of health” . . . . assisting an individual’s suicide does not fit within the ordinary meaning of the phrases “legitimate medical purpose” or “usual course of professional treatment,” because it does not aim to preserve the patient’s health or to cure, alleviate, prevent, or “treat” the disease or its symptoms in the patient.41 the court disagreed. in concluding the controlled substances act did not prohibit physicians from prescribing drugs to help a patient commit suicide in accordance with state law, the court implicitly rejected the claim that legitimate medicine is limited to prescribing drugs for the purpose of healing.42 hence, whatever the merits of this narrow essentialist account as a matter of medical ethics, this approach does not help clarify the scope of legitimate medical practice 40. gonzales v. oregon, 546 u.s. 243 (2006). 41. brief for the petitioners at 18-19, gonzales v. oregon, 546 u.s. 243 (no. 04-623), 2005 wl 1126079, at *18-19. see also letter from henry j. hyde, chairman, committee on the judiciary, u.s. house of representatives, and orrin g. hatch, chairman, committee on the judiciary, u.s. senate, to thomas a. constantine, administrator, drug enforcement administration (july 25, 1997), reprinted in s. rep. no. 105-372, at 7 n.6 (1988) (emphasis added) (discussing a similar position previously taken by several members of congress, writing that “assisting in a suicide by prescribing or filling a prescription for a controlled substance cannot be a ‘legitimate medical purpose’ under dea regulations, especially when the practice is not reasonable and necessary to the diagnosis and treatment of disease and injury, legitimate health care, or compatible with the physician's role as healer.”). 42. gonzales, 546 u.s. at 270 (“congress regulates medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood.”). 2024] drug dealing and the internal morality of medicine 69 when construing the controlled substances act. b. external morality other observers deny the existence of an internal morality of medicine and instead argue that “all judgments in bioethics must be guided and ultimately justified by ethical norms external to the practice of medicine.”43 “only by looking outside of medicine,” robert veatch argues, “can a health professional or anyone else know what the proper ends of medicine are and therefore know what constitutes the ethical practice of the profession.”44 in this view, since the physician is charged with benefiting the patient (and what counts as a benefit depends on the patient’s social context and debates regarding what constitutes human flourishing), determining which practices are ethical for doctors to perform always requires invoking considerations that are external to the medical profession.45 “[i]n order to know what the ends of medicine are, one must first know what the ends of living and social functioning are and . . . this, in turn, requires turning outside of any conception of medicine to determine.”46 veatch illustrates his argument with a colorful hypothetical example of a society in which priestly castrati play an important and honored cultural role.47 preserving the soprano voices of male cantors requires castrating them at puberty. veatch argues it is impossible to determine whether physicians in such a society could ethically perform these castrations on healthy boys simply by reflecting on the essential nature of medicine. “the rightness or wrongness of the surgeons’ actions depends not on any goals of medicine,” veatch claims, “but rather on the correctness of the society’s broader cultural beliefs and rituals.”48 in other words, if the castrations themselves are ethical, it is ethically permissible for physicians to perform them. no morality internal to the profession would bar them from doing so. a real example may further illustrate this argument. consider prescribing hormone-blockers to a transgender woman to help her express her gender identity. does this intervention promote the patient’s health? hormone blockers do not heal the patient’s body; in fact, they disrupt the body’s normal processes. yet even if one were to limit legitimate medicine to healing, presumably physicians could still ethically prescribe this intervention if transgenderism itself were considered an illness. views on that question have shifted over time in response to shifting social mores and norms—norms that are themselves external to medicine.49 as veatch argues, “[t]hat the purpose of medicine is health or 43. arras, supra note 33, at 644. 44. veatch, supra note 10, at 623. 45. id. 46. id. at 628. 47. id. at 625-26. 48. id. at 634. 49. jodie m. dewey & melissa m. gesbeck, (dys)functional diagnosing: mental health 70 indiana health law review [vol. 21:61 healing tells us nothing more than that the purpose of medicine is to solve what is (properly) perceived to be a problem in the medical realm without telling anything whatsoever about what would constitute such a problem and what would count as a solution.”50 in terms of informing legal questions regarding which practices count as “medical,” an external account is appealing because the regulation of medicine is inherently an exercise in applying external (legal) standards to the profession. the external approach seems to view the medical profession as a tool society uses to produce certain benefits. in this view, it is appropriate for society to place within medicine’s lawful domain any problem for which physicians’ skills and expertise may be beneficial. as tom beauchamp argues: if beneficence is a general moral principle (and it is), and if physicians are positioned to supply many forms of benefit (and they are), then there is no manifest reason to tie physicians’ hands or duties to the single benefit of healing. patients and society may, with good reason, regard cosmetic surgery, sleep therapies, assistance in reproduction, genetic counseling, hospice care, physician-assisted suicide, abortion, sterilization, and other actual or potential areas of medical practice as important benefits that only physicians can safely and efficiently provide. these activities are not forms of healing . . . .51 accordingly, veatch concludes that “[i]f the society is justified in condoning the behavior, it is potentially justified in expecting those in health professional roles to engage in them when these are the only people who can perform them.”52 yet although this approach avoids narrow essentialism’s rejection of common nontherapeutic practices, it does little to help answer questions regarding what falls within the legal scope of medicine. while the standard proposed by many essentialist accounts may be too cramped to encompass the full range of legitimate medicine, proponents of externalist accounts do not offer an alternative standard of their own. they merely argue that these questions cannot be answered simply by reflecting on medicine’s purposes. instead, resort must be made to external accounts of what is ethical in general.53 while this may be a valid way of assessing whether a particular practice is ethical, it offers little help in determining whether that practice qualifies as “medical” in nature. for example, one could believe it is unethical to prescribe hormone blockers to transgender patients without believing that a physician who does so is not practicing medicine. moreover, the laws regulating physician diagnosis, medicalization, and the making of transgender patients, 41 human. & soc’y 37 (2017). 50. veatch, supra note 10, at 636. 51. beauchamp, supra note 10, at 603. 52. veatch, supra note 10, at 635. 53. see, e.g., beauchamp, supra note 10, at 612 (offering a defense of externalism that “appeals to universal moral principles that are valid independent of the perspectives of particular communities and traditions of medical practice and ethics.”). 2024] drug dealing and the internal morality of medicine 71 prescribing are expressly predicated on the idea that legitimate medicine is defined by certain “purposes.”54 since external accounts seem to reject that premise, they are not helpful in distinguishing acts that are distinctively medical from those that lie outside that scope. c. evolutionary dialogue another camp has sought to strike a middle ground between the internal and external views. these theorists endorse a hybrid approach, insisting that an internal morality does limit the proper goals of medicine, while also arguing that these goals can evolve in response to shifting social contexts. a consensus report produced by the hastings center illustrates this approach. the report argues “medicine has essential ends, shaped by more or less universal ideals and kinds of historical practices, but its knowledge and skills also lend themselves to a significant degree of social construction.”55 hence, while the aims of medicine may have traditionally been limited to healing, over time—in dialogue with a changing society—the boundaries of the practice have expanded to include additional objectives that are now central to medicine. according to the authors, today the “goals of medicine” include: (1) “the prevention of disease and the promotion of health,” (2) “the relief of pain and suffering,” (3) “the treatment of disease and the care of those who cannot be cured,” and (4) “the avoidance of a premature death and the promotion of a peaceful death.”56 miller and brody propose a similar compromise. these authors purport to endorse an internal morality of medicine while arguing that “the goals of medicine are not timeless and unchanging; of necessity they evolve along with human history and culture.”57 miller and brody believe that “healing, promoting health, and helping patients achieve a peaceful death” traditionally have been central to the practice of medicine.58 but they argue that medicine’s scope cannot be limited to healing alone, because traditional goals can be reinterpreted to permit new practices and “social forces” can result in new goals being added to medicine’s purview.59 in this view, there are goals that are “core” or “central” to medicine because they have been recognized as an appropriate part of medical care for a long time. 54. 21 c.f.r. § 1306.04(a) (2020). 55. daniel callahan, the goals of medicine: setting new priorities, in 26 hastings ctr. rep. (special supplement) 1 (1996), reprinted in the goals of medicine: the forgotten issues in health care reform 1, 17 (mark j. hanson & daniel callahan eds., geo. univ. press 1999). 56. id. at 17. 57. franklin g. miller & howard brody, the internal morality of medicine: an evolutionary perspective, 26 j. med. & phil. 581, 585 (2001). 58. franklin g. miller & howard brody, professional integrity and physician-assisted death, 25 hastings ctr. rep. 8, 12 (1995). 59. miller & brody, supra note 57 at 585. 72 indiana health law review [vol. 21:61 but those goals can also evolve via “responsive adaptation to the circumstances of the present.”60 when a particular practice becomes accepted in the broader society, it may be appropriate for the goals of medicine to expand to encompass these practices. answering that question, the authors argue, that it requires determining “whether the proposed alteration would represent a possibly positive evolution in the nature of medicine, or whether the degree of violence done to traditional medical values is simply too great to allow the change.”61 ultimately, miller and brody settle on a list that they claim reflects the range of goals that are properly within medicine’s domain: 1. reassuring the “worried well” who have no disease or injury; 2. diagnosing the disease or injury; 3. helping the patient to understand the disease, its prognosis, and its effects on his or her life; 4. preventing disease or injury if possible; 5. curing the disease or repairing the injury if possible; 6. lessening the pain or disability caused by the disease or injury; 7. helping the patient to live with whatever pain or disability cannot be prevented; 8. when all else fails, helping the patient to die with dignity and peace.62 by identifying specific goals that define medicine’s proper scope, these evolutionary accounts offer potential tools for evaluating whether a physician acted with a legitimate medical purpose in prescribing a drug. under such an approach, if the physician’s purpose in writing a prescription is to pursue one of these specified purposes, the physician has acted within the legitimate scope of medicine. if not, the physician has not acted as a practitioner in writing the prescription. that benefit proves illusory, however, because the proponents of these lists do not claim that the goals they identify are the only objectives physicians may properly pursue. while the hastings center’s consensus report identifies four goals as the legitimate aims of medicine, they conclude it is sometimes permissible for physicians to engage in “nonmedical” practices as well.63 for example, they argue that although contraception and cosmetic surgery “fall outside the traditional goals of medicine,” it is still acceptable for physicians to provide these services in pursuit of “social and individual purposes” besides promoting health.64 miller and brody likewise assert that “[b]esides medical activities which are 60. id. at 586. 61. id. at 585. 62. howard brody & franklin g. miller, the internal morality of medicine: explication and application to managed care, 23 j. med. & phil. 384, 386-87 (1998). 63. callahan, supra note 55 at 31. 64. id. at 30. 2024] drug dealing and the internal morality of medicine 73 fully consistent with medicine’s internal morality, and those which violate that morality, there may be a third category: activities which are considered morally permissible for physicians, but which occupy a borderline status in relation to internal morality.”65 for example, the authors argue contraception “arguably fails to promote any medical goal, since fertility is not a disease,” and conclude that physicians prescribing contraception cannot be justified “on a principled basis.”66 yet in their view this does not mean it is unethical for doctors to do so, because physicians’ expertise and skill make them uniquely qualified to provide this important service: [w]e could envision a hypothetical negotiation between the medical profession and the larger society. imagine that everyone agreed that contraception and sterilization are social goods, everything being equal. when push comes to shove, there seem to be two ways to provide this good. either physicians will stretch a point and agree to provide this service despite the potential compromise of their professional integrity . . . . or, society will somehow create a new set of professionals or technicians who will learn these skills . . . . all might readily agree that the first course of action is a much wiser use of all sorts of social resources than the second.67 accordingly, in this view some practices that do not aim at the traditional medical goals of promoting health, such as contraception or cosmetic surgery, can still be properly performed by physicians. the authors “suggest a normative mapping of medicine that encompasses a core of legitimate medical practice, consistent with the goals and internal duties of medicine, a periphery of more or less acceptable procedures and practices outside the core, and a range of violations beyond the pale of medical legitimacy.”68 thus, rather than offering a clear principle that can help determine when a physician has ceased acting as a physician, this approach posits that legitimate medical practice includes traditional goals, such as healing, as well as many other practices society has enlisted doctors to perform. as boorse notes, in the evolutionary view nontherapeutic practices such as cosmetic enhancement or assisted suicide “if they are in patients’ best interests, will either be genuine medicine, or something besides medicine that physicians can permissibly do – in either case acceptable.”69 such a standard appears of little use in seeking to determine when a physician has exceeded the scope of legitimate practice. 65. howard brody & franklin g. miller, the internal morality of medicine: explication and application to managed care, 23 j. med. & phil. 384, 390 (1998). 66. id. at 391. 67. id. at 392. 68. franklin g. miller et al., cosmetic surgery and the internal morality of medicine, 9 cambridge q. healthcare ethics 353, 356 (2000). 69. boorse, supra note 11, at 173. 74 indiana health law review [vol. 21:61 d. broad essentialism for purposes of construing federal prescribing rules, the external and evolving accounts are unhelpful for the same reasons: they do not help decide concrete cases that hinge on whether a physician ceased acting as a physician. by contrast, pellegrino’s essentialist account provides a clear standard for making this determination—namely, that acts not aimed at healing do not qualify as medical in nature—but this narrow definition of medicine’s scope is flatly inconsistent with existing law. an internal standard that articulates a principle for determining which acts are “medical” would be useful, but that principle must be broad enough to embrace the wide range of legal, nontherapeutic practices that medical practitioners commonly perform. an analysis offered by christopher boorse provides such a standard. boorse argues that if medicine is governed by an internal morality, it is a broad one. he rejects the narrow form of essentialism that seeks to confine medicine to the aim of healing, finding that “[a]s a matter of history, whenever one supposes the western medical tradition began, physicians from the start have done things other than to fight disease and promote health.”70 noting that hippocratic doctors routinely provided both contraceptive and abortion interventions for no health-related purpose, boorse argues medicine has embraced non-therapeutic aims from the dawn of the profession.71 for those who instead trace modern medicine’s origins to the rise of germ theory circa 1865, boorse notes that victorian-era physicians quickly embraced obstetrical anesthesia as ethical, despite the fact that pain caused by labor is normal rather than pathological.72 having rejected the view that medicine can be limited to healing alone, boorse argues that other proposed lists of medicine’s goals, such as those offered by the hastings center and miller and brody, can be consolidated under the headings of (1) “[p]reventing pathological conditions,” (2) “[r]educing the severity of pathological conditions,” and (3) “[a]meliorating the effects of pathological conditions.” but because these authors also claim physicians may also use their skills to provide nontherapeutic interventions, such as contraception and plastic surgery, the list of physicians’ permissible goals must also include a fourth goal: “[u]sing biomedical knowledge or technology in the best interests of the patient.”73 and once one acknowledges this fourth item as a permissible goal for physicians, this objective subsumes the other three: “[f]or it is undisputed that the pursuit of all the other goals is justified only when it is in the patient’s interest.”74 in sum, boorse concludes that if medicine is governed by an internal 70. id. at 146. 71. id. at 166. 72. id. at 148, 170. 73. id. at 170 (boorse also identifies a list for medical goals regarding the development of scientific knowledge, but those are inapplicable here). 74. id. at 172. 2024] drug dealing and the internal morality of medicine 75 morality, that morality does not limit doctors to specific practices but rather to a broadly-stated end: using their special expertise and skills to promote the patient’s well-being. by framing the goal of medicine at this level of abstraction, this approach goes a long way toward reconciling the essentialist, evolutionary, and external accounts. it offers an essentialist account that acknowledges a morality at the core of medicine that constrains its practitioners. but it defines that core principle broadly enough to encompass the ways in which what constitutes “benefit” hinges on external considerations: the morality of the broader society, shifting social contexts, and individual preferences. thus, for example, under this standard, physicians could not ethically participate in executions even if performing executions were justifiable according to external moral principles, because killing would violate the internal morality of medicine that commits doctors to benefiting their patients. at first blush, this standard may seem too broad and abstract to be useful in evaluating the propriety of a physician’s prescriptions. like the external and evolutionary accounts, this approach does not identify specific practices doctors should abstain from performing. but unlike those accounts, boorse provides a principle for determining when a physician has ceased acting as a physician. this standard also focuses attention on the factors that are relevant when undertaking that assessment: in engaging in certain conduct, was the physician trying to use her skills and expertise to benefit the patient? or did the doctor have some other aim, such as profit-seeking, irrespective of whether it benefited the patient? in other words, rather than focusing on whether a physician prescribed too much, too frequently, or in other ways that might deviate from the standard of care, the inquiry into whether a physician had a legitimate medical purpose should focus on the physician’s motivations—in particular—whether the doctor was reasoning like a fiduciary. iii. a fiduciary prescribing standard from its inception, benefiting patients has been at the core of the medical profession. according to one translation of the hippocratic oath, a doctor pledges to “follow that system of regimen which, according to my ability and judgment, i consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.”75 plato observed in the republic that “[n]o physician, insofar as he is a physician, considers his own good in what he prescribes, but the good of his patient; for the true physician is . . . not a mere money-maker.”76 millenia later, the preamble to the american medical association’s (ama) principles of medical ethics observes that the profession’s ethical principles were “developed 75. oath of hippocrates, reprinted in allan h. mccoid, the care required of medical practitioners, 12 vand. l. rev. 549, 549 (1959). 76. sam f. halabi, against fiduciary utopianism: the regulation of physician conflicts of interest and standards of care, 11 u.c. irvine l. rev. 433, 445 (2020), (quoting plato, the republic 17 in cosmio classics (benjamin jowett trans., 2008) (1888)). 76 indiana health law review [vol. 21:61 primarily for the benefit of the patient.”77 thus, although physicians are compensated for their work, they are situated differently than providers of most other services. when laypeople enter into economic transactions, they are generally free to maximize their own benefit from those exchanges. it is incumbent on the other party to the transaction to look out for her own interests.78 but members of certain professions, such as lawyers and financial advisors, are considered fiduciaries who are required by both ethical standards and legal restrictions to prioritize the wellbeing of their clients.79 fiduciary duties are often imposed on professionals who “have specialized knowledge or expertise.” their work requires judgment and discretion. often the party that the fiduciary serves cannot effectively monitor the fiduciary’s performance. the fiduciary relationship is based on dependence, reliance, and trust.”80 because the doctor-patient relationship fits all these criteria, it has frequently been characterized as a fiduciary relationship. as several legal scholars have observed, this is not strictly accurate—the law does not treat physicians as fiduciaries in every respect.81 at a minimum, however, doctors do owe ethical duties to act as fiduciaries in some respects, including by prioritizing patients’ well-being above their own financial interests. an ama report on conflicts of interest asserts that “a physician must exercise medical judgment independently of his own . . . financial interests.” the report states that conflicts between the physician’s and the patient’s interest “must be resolved to the patient’s benefit.” these benefits derive, according to the ama, from the “physician’s role as a fiduciary, i.e., a person who, by his undertaking, has a duty to act primarily for another’s benefit.” the american college of physicians declares that the physician is “the advocate and champion of his patient, upholding the patient’s interests above all others.” they add that “[t]he physician must avoid any personal commercial conflict of interest that might compromise his loyalty and treatment of the patient.”82 in other words, although physicians are paid for their services—and in that sense 77. ama principles of medical ethics, ama code of med. ethics, https://code-medicalethics.amaassn.org/principles#:~:text=the%20medical%20profession%20has%20long,health% 20professionals%2c%20and%20to%20self. [https://perma.cc/3kec-w7v9]. (last visited mar. 6, 2023) 78. justin sevier & kelli alces williams, consumers, seller-advisors, and the psychology of trust, 59 b.c. l. rev. 931, 940 (2018). 79. halabi, supra note 75 at 438-40. 80. marc a. rodwin, strains in the fiduciary metaphor: divided physician loyalties and obligations in a changing health care system, 21 am. j. l. & med. 242, 244 (1995). 81. rodwin, supra note 79, at 247; halabi, supra note 75 at 452. 82. rodwin, supra note 79, at 246-47 (quoting am. med. ass’n, report of the council on ethical & jud. aff., report a (i-86): conflicts of interest 11 (1986)); american college of physicians, ad hoc committee on medical ethics, american college of physicians ethics manual, part 1, 101 annals internal med. 129, 134 (1984). 2024] drug dealing and the internal morality of medicine 77 commonly “prescribe for profit”—when the patient’s interest runs counter to the physician’s, the physician is obligated to prioritize the patient’s wellbeing. according to the ama’s code of medical ethics, “[u]nder no circumstances may physicians place their own financial interests above the welfare of their patients . . . physicians should not provide wasteful and unnecessary treatment . . . solely for the physician’s financial benefit.”83 this description of physicians’ duties matches boorse’s account of what is distinctive about the physician’s role: the application of the physician’s special skills and knowledge to benefit the patient.84 it is also consistent with an approach to defining the scope of medicine that has sometimes, though not always, found purchase among courts and legal scholars construing federal rules governing prescribing. most notably, diane hoffmann has argued that in determining whether physicians prescribed without a legitimate medical purpose, the key inquiry should be whether they used their prescribing power to seek personal profit, irrespective of whether the patients would benefit or be harmed.85 courts, too, have sometimes explicitly endorsed this standard. noting that “[i]mplicit in the registration of a physician is the understanding that he is authorized only to act ‘as a physician,’” the united states supreme court concluded the controlled substances act’s criminal penalties are aimed at doctors “who sold drugs . . . ‘primarily for the profits to be derived therefrom.’”86 more recently, an appellate court concluded that conviction under the controlled substances act required proving that the physician’s “authority to prescribe controlled substances was being used not for treatment of a patient, but for the purpose of assisting another in the maintenance of a drug habit or of dispensing controlled substances for other than a legitimate medical purpose, i.e. the personal profit of the physician.’”87 at one point even the dea sought to allay doctors’ concerns about the vague and shifting standards governing prescribing by insisting that the agency only targeted physicians who “knowingly and intentionally prescribe opioid medications for profit or other personal gain.”88 however, the dea subsequently disavowed the document that contained that 83. am. med. ass’n, opinion 11.2.2: conflicts of interest in patient care, ama code of med. ethics, https://www.ama-assn.org/delivering-care/ethics/conflicts-interest-patient-care [https://perma.cc/u9r3-q5fk]. (last visited mar. 6, 2023) 84. boorse, supra note 11, at 172 (noting that “[i]ndeed, the limitation to action in the patient’s interest is not unique to medicine: it also restricts every other profession, such as law or investment management, that includes a fiduciary duty to clients.”). 85. see hoffmann, supra note 12. 86. united states v. moore, 423 u.s. 122, 135, 141 (1975) (quoting h.r. rep. no. 91-1444, 10). 87. united states v. katz, 445 f.3d 1023, 1028 (8th cir. 2006) (emphasis added). 88. drug enforcement administration et al., prescription pain medications: frequently asked questions and answers for health care professionals and law enforcement personnel, 19 j. pain & palliative care pharmacotherapy 71, 93 (2005) (emphasis added). 78 indiana health law review [vol. 21:61 statement,89 and courts have not always applied this standard to prosecutions of physicians under the controlled substances act.90 boorse’s account offers support for consistently applying this fiduciary-based standard to prosecutions of physicians for unlawful prescribing. this standard also focuses attention on the kinds of evidence that should be relevant in prosecutions of doctors for abusing their prescribing powers in violation of federal drug laws. because courts have not been consistent in applying this standard, many prosecutions of physicians have focused on whether the physician prescribed in accordance with prevailing medical standards (i.e. whether the physician met the standard of care).91 an expert witness looks through the physician’s prescribing history and expresses the opinion that the doctor prescribed too frequently or in excessive dosages, or that the doctor should have detected that patients were diverting their prescribed medications.92 while this evidence is clearly relevant to whether a physician was acting as a drug trafficker, it should not be sufficient on its own and should not be considered the ultimate issue. instead, evidence of this sort is relevant only insofar as it helps establish that the physician’s prescriptions were motivated by a desire to profit from drug trafficking, irrespective of patient benefit.93 as leib and galoob note, the fiduciary duty of loyalty demands that fiduciaries “have or form certain attitudes and that [they] think or deliberate in certain ways.”94 harmful prescribing may be a breach of the duty of care, but it is only a breach of the duty of loyalty if the physician’s motivations were not “shaped by the beneficiary’s interests.”95 cases involving convictions of doctors for violating the csa provide examples of the kinds of behavior that evidence a breach of this duty. for example, the conviction of dr. permaeshwar singh was supported not merely by the large volume of drugs he prescribed, but by the fact that he prescribed some 76,000 pills without even being present at the office—a feat achieved by presigning blank prescriptions and allowing non-medical office personnel to 89. dispensing of controlled substances for the treatment of pain, 69 fed. reg. 67170, 67170 (nov. 16, 2004). 90. see discussion infra part i. 91. hoffmann, supra note 12, at 286. 92. id. 93. id. at 306 (physicians should not be convicted for violating the csa on the basis of poor prescribing practices unless the record also includes evidence that “the physician received a tangible benefit (in excess of ordinary fees) for his prescribing.” granted, a physician prescribing amounts of addictive drugs wildly in excess of professional standards may be very strong evidence that the physician was acting as a drug trafficker. but the fact that the physician’s practices violated customary practices should not be considered the ultimate inquiry. it is merely evidence that bears on the physician’s motivations.). 94. ethan j. leib & stephen r. galoob, fiduciary political theory: a critique, 125 yale l. j. 1820, 1829 (2016) (citing geoffrey brennen et al., explaining norms 193, 245 (2013)). 95. id. 2024] drug dealing and the internal morality of medicine 79 complete them for patients upon request.96 another convicted physician, dr. thomas moore, prescribed drugs as frequently as his patients requested without even examining them and charged them based on the volume of drugs prescribed.97 and in an administrative action to revoke the dea registration of dr. robert smith, the accused physician wrote prescriptions to individuals he had not examined, charged patients a $65 fee for each office visit plus an additional $100 for prescriptions, and asked one patient for sexual favors in exchange for prescriptions. these are indications that these physicians were not prescribing for the purpose of benefitting patients, and therefore were not acting as physicians in so doing.98 by contrast, clarifying the legal standard to focus on physicians’ motivations rather than mere negligence could exonerate physicians like dr. robert ignasiak. the evidence showed dr. ignasiak examined his patients before prescribing medications for them, treated them for a broad range of conditions with a variety of non-narcotic medications, and took steps to protect against addiction and abuse.99 the physician’s patients suffered from “illnesses or conditions that caused them pain, anxiety and/or depression, ailments that could well have justified the use of controlled substances within the range of discretion accorded physicians.”100 moreover, dr. ignasiak’s prescriptions never exceeded the dosages or amounts listed in the physician’s desk reference (“the leading drug reference among physicians”101).102 nevertheless, the court determined he could be convicted under the controlled substances act merely because he was “on notice” that his prescriptions were harming patients and, based on some of his patients’ abuse of the narcotics he prescribed, he should have known “that perhaps there was something wrong with the way that he was prescribing controlled substances.”103 it may well be that dr. ignasiak was engaging in harmful prescribing practices that did not conform to professional standards, or that he was negligent 96. united states v. singh, 390 f.3d 168, 176 (2d cir. 2004). 97. moore, 423 u.s. at 142-43. 98. see generally united states v. rosen, 582 f.2d 1032, 1035-36 (5th cir. 1978) (noting that in many cases affirming convictions of physicians under the csa, courts have seized on the fact that the defendant did not conduct any examination of her patients before prescribing controlled substances); katz, 445 f.3d at 1027-28 (in affirming the defendant’s conviction under the csa, the court emphasized the physician’s practice of prescribing narcotics without first examining patients). 99. united states v. ignasiak, 667 f.3d 1217, 1220-1221, 1223, 1226 (11th cir. 2012). 100. id. at 1228. 101. jay s. cohen, dose discrepancies between the physicians’ desk reference and the medical literature, and their possible role in the high incidence of dose-related adverse drug events, 161 archives internal med. 957, 958 (2001) (last visited dec. 20, 2023), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/647832 [https://perma.cc/4ez6e2lj]. 102. ignasiak, 667 f.3d at 1228. 103. id. at 1236. 80 indiana health law review [vol. 21:61 in failing to detect that his patients were diverting their medications. but the standard applied in evaluating his conduct, and the evidence emphasized in supporting his conviction, seemed to suggest such violations of professional standards, by themselves, constituted prescribing without a legitimate medical purpose. consistently applying a standard focused on the physician’s motives for prescribing could change outcomes in prosecutions under the controlled substances act. conclusion whether a practice or intervention is considered “medical” can carry important legal consequences. yet the law has not always been rigorous in defining which practices meet this description, yielding standards that are unclear and inconsistent. the law can benefit from drawing on the philosophical debate that has engaged with the complexity of this question. in the context of prescribing laws, boorse offers a useful standard for determining when a physician is acting within the legitimate bounds of medicine. this fiduciary standard is acceptable because it embraces the full range of practices that physicians routinely perform and that are widely accepted as legal. and it is a useful standard because it focuses attention on the key inquiry: whether, in writing a prescription, the doctor was seeking to benefit the patient or to profit irrespective of the patient’s wellbeing. while courts have sometimes asserted that a similar standard governs cases involving unlawful prescribing, boorse’s account offers support for consistently applying this standard to all cases. yet even if boorse’s account helps clarify the appropriate legal standard, that does not mean the application of that standard will be clear in every case. the practice of medicine involves unavoidable financial conflicts of interest.104 since physicians are generally paid for their services—and often earn more for prescribing more therapy—profit motive will be present in many prescribing decisions. determining whether a physician has pursued that profit motive without regard for the patient’s benefit is a fact-intensive inquiry that will not always yield obvious answers. but conflicts of interest are not unique to medical practice, nor is it unusual for legal standards to require case-by-case application by factfinders. the standard offered by boorse offers value by clarifying the central question those factfinders must answer and by specifying the kinds of evidence that are relevant to that inquiry. nevertheless, the utility of boorse’s standard for assessing conformity with the controlled substances act does not necessarily suggest this would be the most useful standard for resolving other questions regarding the definition of medicine. as arras notes, whether it is useful to specify an internal morality that governs legitimate medical practice may hinge critically on “[w]hat . . . an internal morality of medicine [is] for.”105 for example, while this standard tells 104. halabi, supra note 75, at 461-62. 105. arras, supra note 33, at 650 (emphasis in original). 2024] drug dealing and the internal morality of medicine 81 us that a doctor who prescribes botox is providing a “medical” service, it seems to offer little help in determining whether botox is “medically necessary” for purposes of insurance reimbursement. nor does the utility of this standard in assessing compliance with federal prescribing laws mean it is the best approach to resolving ethical issues regarding permissible physician conduct. the question of what physicians can lawfully do without violating federal drug laws is distinct from the question of what practices physicians can ethically undertake. the fact that prescribing drugs to help a patient commit suicide does not violate the csa does not mean doctors should do so. and in resolving that ethical question, it may be that boorse’s emphasis on benefitting the patient offers little help, because it does not attempt to specify what should count as a benefit to the patient. finally, it is important to emphasize that limiting the scope of physicians’ liability under federal drug laws does not mean physicians cannot face other legal consequences for harmful prescribing practices. doctors can face discipline from state medical boards when they violate professional standards.106 they can also face civil liability when that conduct harms patients.107 these are appropriate remedies for physicians who practice medicine poorly. but criminal penalties for unlawful prescribing should be reserved for doctors who abandoned their professional roles altogether in favor of profiting from drug trafficking. 106. lamkin, supra note 5, at 432-33. 107. id. indiana health law review volume xix 2022 number 1 notes virtual learning in a pandemic and its effects on lower-income students: how the education gap is widening beyond repair alaina goschke* i. introduction on march 13, 2020, president trump declared a national emergency in response to the outbreak of coronavirus (“covid-19”) in the united states.1 on march 16, twenty-seven states issued orders or recommendations to close all public schools, thus halting in-person learning.2 by march 25, all public school buildings in the united states were closed, and by may 6, all states and washington d.c. continued the closure for the remainder of the school year, with the exception of wyoming and montana.3 before schools were to reopen in the fall for the new school year, the centers for disease control and prevention (“cdc”) released a list of considerations for mitigation strategies to protect students and staff.4 among the list of things to consider were: “promoting behaviors that reduce covid-19’s spread, maintaining healthy environments, maintaining healthy operations, [and] preparing for when someone gets sick.”5 there is low risk of contracting covid-19 if students and teachers engage virtually, some risk if they engage in a hybrid style where some students participate in-person and some virtual or with smaller class sizes, and the highest * j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.s., 2019, central michigan university. a special thank you to my note advisors, dr. stephanie boys and professor allison martin, professors of law at indiana university robert h. mckinney school of law, for their insight throughout the writing process. 1. declaring a national emergency concerning the novel coronavirus disease (covid19) outbreak, 85 fed. reg. 15337 (mar. 13, 2020). 2. the coronavirus spring: the historic closing of u.s. schools (a timeline), educ. wk. (july 1, 2020), https://www.edweek.org/ew/section/multimedia/the-coronavirus-spring-the-historicclosing-of.html [https://perma.cc/n2rf-j36e]. 3. id. 4. operating schools during covid-19: cdc’s considerations, ctr. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools. html [https://perma.cc/9746-e4w8] (last visited oct. 31, 2020). 5. id. 158 indiana health law review [vol. 19:157 risk if students and teachers were to engage only in-person.6 with these risk levels in mind, only governors of four state—iowa, arkansas, texas, and florida—ordered their schools to reopen in the fall, while most left the decision in the hands of each individual school district within the state.7 fall reopening plans varied nationwide from fully in-person to completely online, with the majority implementing a mix of both in-person and online learning.8 “nearly 93% of people in households with school-age children reported their children engaged in some form of ‘distance learning’ from home [. . .].”9 however, participation in online learning varied by household income: 85.8% of school children living in a household with an income of $100,000 or more reported using online resources, compared to just 65.8% of school children living in a household with an income less than $50,000.10 a. education in the judiciary in 1954, the supreme court of the united states stated education is a “principal instrument in awakening the child to cultural values, in preparing him for later professional training, and in helping him to adjust normally to his environment.”11 the court further stated “it is doubtful that any child may reasonably be expected to succeed in life if he is denied the opportunity of an education.”12 with this in mind, almost every country has the term “education” in their constitution except one: the united states of america.13 however, while not at a federal level, all fifty states mandate public education in their individual state constitutions.14 in 1982, the supreme court held that, under the equal protection clause of the fourteenth amendment, states are not allowed to deny free public education to any student residing within its borders.15 however, the court has held it is the job of the lawmakers, not the courts, to reform the states’ 6. id. 7. map: where are schools closed?, educ. wk., https://www.edweek.org/ew/section/ multimedia/map-covid-19-schools-open-closed.html [https://perma.cc/3jwe-92du] (last visited nov. 2, 2020). 8. id. 9. kevin mcelrath, nearly 93% of households with school-age children report some form of distance learning during covid-19, u.s. census bureau (aug. 26, 2020), https://www.census.gov/library/stories/2020/08/schooling-during-the-covid-19-pandemic.html [https://perma.cc/5nrh-9hef]. 10. id. 11. brown v. bd. of educ., 347 u.s. 483, 493 (1954). 12. id. 13. alia wong, the students suing for a constitutional right to education, atlantic (nov. 28, 2018), https://www.theatlantic.com/education/archive/2018/11/lawsuit-constitutional-righteducation/576901/ [https://perma.cc/459z-chk8]. 14. id. 15. plyler v. doe, 457 u.s. 202, 230 (1982). 2022] virtual learning in a pandemic and its effect on lower-income students 159 public education systems.16 b. education in the legislature in 1965, president lyndon b. johnson enacted the elementary and secondary education act (“esea”).17 the esea marked the first time the federal government committed to ensuring high quality, equal education by providing additional resources to vulnerable students.18 title i of the esea “provide[d] funding to states and districts to improve education for disadvantaged students.”19 in 1974, congress declared that every citizen in the united states is entitled to an education without financial barriers.20 in 2001, president bush enacted the no child left behind act of 2001 (“nclb”).21 the purpose of nclb was to “close the achievement gap with accountability, flexibility, and choice, so that no child is left behind.”22 section 1001(2) of nclb provided: the purpose of this title is to ensure that all children have a fair, equal, and significant opportunity to obtain a high-quality education and reach, at a minimum, proficiency on challenging state academic achievement standards and state academic assessments. this purpose can be accomplished by(2) meeting educational needs of low-achieving children in our nation’s highest poverty schools [. . .]23 in 2015, president obama enacted the every student succeeds act (“essa”), which replaced nclb24 and reauthorized the esea, including title i.25 similar to nclb, the purpose of the essa is to “provide all children significant opportunity to receive a fair, equitable, and high-quality education, and to close educational achievement gaps.”26 c. school closures throughout history although not to the level of national closure seen during covid-19, schools 16. san antonio indep. sch. dist. v. rodriguez, 411 u.s. 1, 58 (1973). 17. cameron brenchley, what is esea?, homeroom (apr. 8, 2015), https://blog.ed.gov/ 2015/04/what-is-esea/ [https://perma.cc/4dwp-tq2h]. 18. id. 19. mark dynarski & kirsten kainz, why federal spending on disadvantaged students (title i) doesn’t work, brookings (nov. 20, 2015), https://www.brookings.edu/research/whyfederal-spending-on-disadvantaged-students-title-i-doesnt-work/ [https://perma.cc/chb4-37rf]. 20. 20 u.s.c. § 1221-1. 21. see no child left behind act of 2001, pub. l. no. 107-110, 115 stat. 1425 (2002). 22. id. 23. id. at § 1001(2). 24. see every student succeeds act of 2015, pub. l. no. 114-95, 129 stat. 1802 (2015). 25. dynarski & kainz, supra note 19. 26. every student succeeds act § 1001. 160 indiana health law review [vol. 19:157 in the united states closed in 2009 due to the novel h1n1 virus.27 schools were told by the federal government not to close, but many schools felt they needed to in order to slow the spread of h1n1.28 when h1n1 first emerged, “726 k-12 schools in the united states closed, affecting 368,282 students.”29 the department of education recommended that “educators prepare take-home assignments in advance for distribution to affected students and use the internet and telephones to post homework materials, conduct classes, share information and keep teachers, parents, and students in close touch.”30 however, h1n1 and covid-19 have one important difference: covid-19 is much more deadly.31 while schools did close for h1n1, only a small number closed for just a few days in the spring and again in the fall.32 now, the world is experiencing unprecedented times, as the united nations has said the covid-19 pandemic has created “the largest disruption of education systems in history.”33 d. the issue while both the judiciary and the legislature strived toward ensuring equal education,34 that has yet to hold true in practice. funding for public education is mostly done at a local level, which has led schools in high-poverty areas to receive little funding.35 during the 2008-2009 school year, the department of education conducted a study which found “45% of high-poverty schools received less state and local funding than what was typical for other schools in their district.”36 low funding leads to low-quality education.37 covid-19 has only 27. charles krupa, swine flu closes more than 600 schools in u.s., nbc news (oct. 28, 2009, 4:45 pm), https://www.nbcnews.com/id/wbna33520744 [https://perma.cc/yq46-kseg]. 28. id. 29. see tamar klaiman et al., variability in school closure decisions in response to 2009 h1n1: a qualitative systems improvement analysis, 11 bmc pub. health 73 (2011). 30. press release, u.s. dep’t educ., duncan, sebelius unveil recommendations for schools on how learning continues in case of flu outbreak (aug. 24, 2009), https://www.ed.gov/ news/press-releases/duncan-sebelius-unveil-recommendations-schools-how-learning-continuescase-flu-outbreak [https://perma.cc/dk68-vqp5]. 31. ian richardson, fact check: 2009 swine flu spread rapidly, but covid-19 is more deadly, usa today, https://www.usatoday.com/story/news/factcheck/2020/08/13/fact-checkswine-flu-spread-rapidly-but-not-deadly-covid-19/5577001002/ [https://perma.cc/d4e2-cr8m] (last updated aug. 16, 2020). 32. id. 33. mélissa godin, children across europe are going back to school. here’s how 3 countries are managing it, time (sept. 2, 2020, 10:26 am), https://time.com/5885554/europeschools-reopening-germany-scotland-norway/ [https://perma.cc/dj5e-wpj9]. 34. equity of opportunity, u.s. dep’t educ., https://www.ed.gov/equity [https://perma. cc/a728-b4l3] (last visited mar. 29, 2021). 35. id. 36. id. 37. id. 2022] virtual learning in a pandemic and its effect on lower-income students 161 intensified inequalities in education, with 94% of students worldwide being affected and 99% in lowand middle-income countries.38 when covid-19 reached the united states and schools were forced to shut down and move to online learning in march 2020, one in five students were living without a computer or internet access, disproportionately effecting african-american, hispanic, rural area, and low-income families.39 the u.s. census bureau conducted a study after schools closed on how the pandemic impacted children receiving education, and 71.1% of households said their children switched to online learning.40 of children who lived in a household with an income of below $25,000, only 56.4% reported having a computer always available and 57% reported always having internet available.41 of children who lived in a household with an income of $200,000 or more, 89% reported always having a computer available and 90% reported always having internet available.42 with access to computers and internet becoming essential to attending school, “a failure to provide the service to students is akin to barring them from school altogether.”43 “the consequences of the gap between those who [had] access to virtual learning and those who [did] not could be felt for years to come.”44 e. roadmap section ii of this note discusses the history of children in poverty in the united states and how socioeconomic status effects the quality of education for low-income students. it also addresses how the education gap among low-income and affluent students has been deepened in recent years due to the “homework gap” and how children in poverty and education have been addressed at a national level, with the enactment of the national school lunch act. section iii of this note offers an analysis of how covid-19 has widened the education gap beyond repair with the emergence of virtual learning, arguing that low-income students, and even parents, were in dire need to return to in-person learning. additionally, 38. godin, supra note 33. 39. samantha walravens, why online learning is failing our nation’s most vulnerable students, forbes (june 8, 2020, 3:53 pm), https://www.forbes.com/sites/geekgirlrising/2020/06/ 08/new-report-shows-impact-of-digital-divide-on-low-income-students/#7e58d26c1701 [https://perma.cc/9gzn-wjw3]. 40. household pulse survey data tables, u.s. census bureau, https://www.census.gov/ data/tables/2020/demo/hhp/hhp1.html [https://perma.cc/mja5-qxv9] (last visited nov. 7, 2020). 41. id. 42. id. 43. moriah balingit, ‘a national crisis’: as coronavirus forces many schools online this fall, millions of disconnected students are being left behind, wash. post (aug. 16, 2020), https://www.washingtonpost.com/education/a-national-crisis-as-coronavirus-forces-many-schoolsonline-this-fall-millions-of-disconnected-students-are-being-left-behind/2020/08/16/458b04e6d7f8-11ea-9c3b-dfc394c03988_story.html [https://perma.cc/85dz-3r3s]. 44. id. 162 indiana health law review [vol. 19:157 this section analyzes various cities and states in the united states and their handling of education during the pandemic compared to that of other countries, particularly germany, spain, and switzerlandasserting that the united states took a much more detrimental approach. ii. background poverty is defined as an annual income below $25,283 for a family of four.45 in 2017, 12,808,000 children lived in poverty, at about 17.5%.46 living in poverty has a negative impact on a child’s education.47 “one of the most severe effects of poverty in the united states is that poor children enter school with this readiness gap, and it grows as they get older.”48 children living in poverty generally have poor physical health and motor skills, lack the ability to concentrate and remember information, and their attentiveness, curiosity, and motivation is greatly reduced.49 students living in poverty are “already trailing their more privileged peers and rarely, if ever, catch up.”50 there are several benefits for children who attend school that contribute to healthy child development, including educational instruction, the development of social and emotional skills, a safe learning environment, nutritional needs, and the facilitation of physical activity.51 most importantly, for children living in poverty, education can help break the cycle.52 a. the homework gap before covid-19 reached the united states, there was already a growing divide between students who had access to internet and computers and those who did notreferred to as the “homework gap.”53 about 58% of eighth grade students 45. child poverty in american 2017: national analysis, child. def. fund (sept. 12, 2018), https://www.childrensdefense.org/wp-content/uploads/2018/09/child-poverty-in-america-2017national-fact-sheet.pdf [https://perma.cc/7nm4-tmxk]. 46. id. 47. the effects of poverty on education in the united states, childfund (nov. 4, 2013), https://www.childfund.org/content/newsdetail/2147489206/ [https://perma.cc/bfk6-jqzt]. 48. id. 49. id. 50. lyndsey layton, majority of u.s. public school students are in poverty, wash. post (jan. 16, 2015), https://www.washingtonpost.com/local/education/majority-of-us-public-schoolstudents-are-in-poverty/2015/01/15/df7171d0-9ce9-11e4-a7ee-526210d665b4_story.html [https://perma.cc/8kul-zadh]. 51. operational strategy for k-12 schools through phased prevention, ctr. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/community/schoolschildcare/reopening-schools.html [https://perma.cc/ur36-5y8h] (last visited dec. 23, 2021). 52. the effects of poverty on education in the united states, supra note 47. 53. monica anderson & andrew perrin, nearly one-in-five teens can’t always finish their homework because of the digital divide, pew rsch. ctr. (oct. 26, 2018), https://www. pewresearch.org/fact-tank/2018/10/26/nearly-one-in-five-teens-cant-always-finish-their-homework2022] virtual learning in a pandemic and its effect on lower-income students 163 in the united states rely on using the internet at home to complete their homework every day or almost every day and only 6% reported that they never use the internet at home for homework.54 black students, hispanic students, and students in low-income households are the most likely to lack digital access.55 a study conducted in 2018 found that, “17 [percent] of teens said they are often or sometimes unable to complete homework assignments because they do not have reliable access to a computer or internet connection.”56 of teens whose household income is less than $30,000, 24% said they often or sometimes cannot complete their homework due to the lack of a computer or internet.57 only 9% of teens whose household income is $75,000 or more had a similar experience.58 furthermore, 25% of low-income teens do not have access to a computer at home, compared to only 4% of teens whose household income is $75,000 or more.59 b. the national school lunch act the national school lunch act (“nsla”) was enacted in 1946 by president truman.60 the nsla was intended to “safeguard the health and well-being of the nation’s children . . . by assisting the states, through grants-in-aid and other means, in providing an adequate supply of foods and other facilities for the establishment, maintenance, operation, and expansion of nonprofit school lunch programs.”61 the national school lunch program (“nslp”) provides free or reduced-price lunch to children who qualify each school day.62 children may be eligible for the nslp either categorically or by household income.63 there are several ways for a child to be categorically eligible: participation in certain federal assistance programs, homelessness, if they are a migrant, a runaway, or a foster child, or if they are enrolled in a federally-funded head start program or a comparable state-funded program.64 children qualify for free lunch if their because-of-the-digital-divide/ [https://perma.cc/27kd-sv36]. 54. brooke auxier & monica anderson, as schools close due to the coronavirus, some u.s. students face a digital ‘homework gap’, pew rsch. ctr. (mar. 16, 2020), https://www. pewresearch.org/fact-tank/2020/03/16/as-schools-close-due-to-the-coronavirus-some-u-s-studentsface-a-digital-homework-gap/ [https://perma.cc/rva2-bq6q]. 55. anderson & perrin, supra note 53. 56. id. 57. id. 58. id. 59. id. 60. the national school lunch program, u.s. dep’t agric., https://fns-prod.azureedge.net/ sites/default/files/resource-files/nslpfactsheet.pdf [https://perma.cc/k5na-letm] (last updated nov. 2017). 61. 42 u.s.c. § 1751 (1946). 62. the national school lunch program, supra note 60. 63. id. 64. id. 164 indiana health law review [vol. 19:157 household income is at or below 130% of the federal poverty level.65 children qualify for reduced-price lunch if their household income is between 130% and 185% of the federal poverty level.66 in the program’s first year, about 7.1 million students participated, and in 2016, 30.4 million participated.67 in 1966, president lyndon b. johnson enacted the child nutrition act of 1966 (“cna”), which expanded the nslp to include free or reduced-price breakfast for students.68 the cna assisted “the states and the department of defense through grants-in-aid and other means to initiate, maintain, or expand nonprofit breakfast programs in all schools which make application for assistance [. . .].”69 in 2010, president obama enacted the healthy, hunger-free kids act of 2010, which updated the meal patterns and nutritional standards established by the nsla and the cna.70 eating healthy foods is important for children, as it positively effects a child’s growth and development.71 the healthy, hunger-free kids act of 2010 also “works to eliminate hunger during the school day by increasing the number of eligible children enrolled in school meal programs and removing barriers to school meals for children most in need.”72 iii. analysis: covid-19 is causing low-income students to be left behind a. federal covid-19 relief packages the coronavirus aid, relief, and economic security act (“cares act”) was enacted on march 27, 2020 in part to assist in school funding during the pandemic.73 the education stabilization fund allocated $30.75 billion to the department of education to remain available to prevent, prepare for, and respond to covid-19.74 of the $30.75 billion, $13.2 billion was devoted to k-12 education for the elementary and secondary school emergency relief fund, $14 billion for higher education, and $3 billion for the governors emergency education relief fund.75 among the list of allowable uses for the $13.2 billion was 65. id. 66. id. 67. id. 68. 42 u.s.c. § 1773 (1966). 69. 42 u.s.c. § 1773. 70. see healthy, hunger-free kids act of 2010, pub. l. no. 111-296, 124 stat. 3183 (2010). 71. childhood nutrition facts, ctr. for disease control & prevention, https://www. cdc.gov/healthyschools/nutrition/facts.htm [https://perma.cc/t4sa-gpk5] (last visited nov. 8, 2020). 72. 3 c.f.r. § 8733 (2012); see also healthy, hunger-free kids act, 124 stat. at 3183. 73. see coronavirus aid, relief, and economic security act, pub. l. no. 116-136, 134 stat. 281 (2020). 74. id. 75. phyllis w. jordan, what congressional covid funding means for k-12 schools, futureed, https://www.future-ed.org/what-congressional-covid-funding-means-for-k-12-schools/ 2022] virtual learning in a pandemic and its effect on lower-income students 165 “activities to address the unique needs of low-income children or students [. . .].”76 however, some states struggled to actually access the funding due to paperwork, and the states that did access the funds say the cares act just made up for budget cuts in prior years.77 it was not until nine months after the cares act was enacted that another relief package was passed. in december 2020, congress approved, and president trump signed into law, the coronavirus response and relief supplemental appropriations act (“crrsa”).78 the crrsa was a $900 billion covid-19 relief package, with $54 billion designated for k-12 education.79 president biden was sworn into office on january 20, 2021, and his plan was to have schools safely reopened within his first 100 days. on february 5, congress passed the budget for newly-elected president biden’s $1.9 trillion coronavirus relief package.80 on march 11, president biden signed into law the american rescue plan act of 2021 (“american rescue plan”).81 the american rescue plan provided $129 billion for k-12 public education with $123 billion as “part of a stabilization fund for elementary and secondary education that’s distributed through the federal title i formula for disadvantaged students.”82 “local school districts will receive at least 90 percent of that stabilization fund, but they must earmark one dollar out of every five for learning recovery programs.”83 the american rescue plan also attempted to directly reduce child poverty by temporarily changing federal tax law regarding the child tax credit, a change president biden hopes to make permanent.84 the american rescue plan raised the tax credit from $2,000 to $3,600 per child and is sent to families in installments over the course of the year.85 the new law is set to reach more lowincome families, whereas previously the law mostly reached middleand high[https://perma.cc/6wwu-nxsn] (last visited july 23, 2021). 76. id. 77. kalyn belsha, as cares act helps some schools, many say it’s just a down payment on what districts need to avoid financial disaster, chalkbeat (july 10, 2020, 1:50 pm), https://www.chalkbeat.org/2020/7/10/21320206/cares-act-down-payment-on-what-schools-reallyneed-avoid-financial-disaster [https://perma.cc/chq9-ebp6]. 78. jordan, supra note 75. 79. id. 80. id. 81. see american rescue plan act of 2021, pub. l. no. 117-2, 135 stat. 4 (2021). 82. andrew ujifusa, see what the huge covid-19 aid deal biden has signed means for education, in two charts, educ. wk. (mar. 11, 2021), https://www.edweek.org/policy-politics/ see-what-the-huge-covid-19-aid-deal-biden-has-signed-means-for-education-in-two-charts/2021/03 [https://perma.cc/v74f-qrwk]. 83. id. 84. valerie strauss, biden’s american rescue plan is actually a huge new school reform, wash. post (mar. 11, 2021, 6:21 pm), https://www.washingtonpost.com/education/2021/03/11/ biden-rescue-plan-actually-huge-new-school-reform/ [https://perma.cc/7hls-6hgh]. 85. id. 166 indiana health law review [vol. 19:157 income families.86 b. low-income areas vs. high-income areas while covid-19 affected students and schools across the nation, students in low-income areas had a harder time accessing their education than students in high-income areas.87 two california elementary students had two completely different experiences when covid-19 shut down their respective schools.88 maria, who lives in a school district where 90% of students are from low-income families, had a difficult time accessing virtual learning.89 she did not have a computer, so she joined class using her mother’s cellphone but the connection kept droppingshe gave up trying after one week.90 she finally received a computer in june 2020, but by that time she already felt behind.91 another student, cooper, lives in a school district where only 12% of students are from low-income families.92 cooper’s school issued him a computer and his family had access to the internet from their home.93 it took cooper’s school less than one week to get class completely switched to onlineequipped with agendas, online assignments, and virtual hangouts with teachers.94 only half of california students in low-income districts had access to a computer when california first shut down, compared to 87% of students in affluent districtsrising to 98% just three weeks after the shutdown.95 despite this disparity in access to online resources, 53% of low-income parents of k-12 students say their child participated in online-only schooling compared to 40% of upper-income students.96 of those upper-income students who participated in online learning, 19% hired someone to provide additional instruction.97 “gaps in access to school resources fall along racial and 86. id. 87. paloma esquivel et al., a generation left behind? online learning cheats poor students, times survey finds, l.a. times (aug. 13, 2020, 5:00 am), https://www.latimes.com/ california/story/2020-08-13/online-learning-fails-low-income-students-covid-19-left-behind-project [https://perma.cc/u826-f385]. 88. id. 89. id. 90. id. 91. id. 92. id. 93. id. 94. id. 95. id. 96. juliana menasce horowitz & ruth igielnik, most parents of k-12 students learning online worry about them falling behind, pew rsch. ctr. (oct. 29, 2020), https://www. pewsocialtrends.org/2020/10/29/most-parents-of-k-12-students-learning-online-worry-about-themfalling-behind/ [https://perma.cc/h9z4-enbu]. 97. id. 2022] virtual learning in a pandemic and its effect on lower-income students 167 socioeconomic lines, and that gap [was] magnified during virtual schooling.”98 while students in low-income areas struggled “to access the most basic remote learning opportunities, often without home internet services and computers, others had the benefit of private tutors or all-day virtual instruction provided by their schools.”99 many students in wealthy neighborhoods attended small learning pods, where they received their education from private instructors that their parents paid hundreds, sometimes thousands, of dollars for.100 while those who could afford to learn from home went back in-person to school, those who needed to return in-person, continued to learn online.101 of the nation’s highest-poverty districts, 41% began the year entirely remote.102 in a survey done among every public school district in california’s bay area’s largest counties, 100% of school districts with a 2019 median household income of at least $200,000 offered students some in-person learning.103 that number dropped all the way down to 12% in districts with median household incomes of $100,000 or less.104 public schools are funded through local property taxes, which produces significant disparities.105 in san antonio independent school district v. rodriguez, the supreme court held the equal protection clause does not require absolute equality where wealth is involved in regard to public education.106 “unequal funding at the state and local levels maintain well-resourced schools in mostly white neighborhoods while those serving mostly black, latino, and lowincome white students struggle to finance basic supplies.”107 “[t]he wealthiest districts spend two to three times what the poorest districts can spend per pupil.”108 in 2015, only twelve states allocated more funds to districts where 98. maya king & nicole gaudiano, the pandemic could widen the achievement gap. a generation of students is at risk, politico (sept. 23, 2020, 7:55 pm), https://www.politico.com/ news/2020/09/23/how-the-coronavirus-is-making-school-segregation-worse-420839 [https://perma.cc/r3u7-2dye]. 99. katie reilly, public schools will struggle even more as parents move kids to private ones during the pandemic, time (aug. 31, 2020, 3:32 pm), https://time.com/5885106/schoolreopening-coronavirus/ [https://perma.cc/d8ae-7tbd]. 100. king & gaudiano, supra note 98. 101. john woolfolk, coronavirus: rich bay area kids head back to class, others stay home, mercury news, https://www.mercurynews.com/2021/02/11/coronavirus-rich-kids-headback-to-class-others-stay-home/ [https://perma.cc/jbl3-c9hg] (last updated feb. 12, 2021). 102. reilly, supra note 99. 103. woolfolk, supra note 101. 104. id. 105. linda darling-hammond, america’s school funding struggle: how we’re robbing our future by under-investing in our children, forbes (aug. 5, 2019, 1:43 pm), https://www.forbes. com/sites/lindadarlinghammond/2019/08/05/americas-school-funding-struggle-how-were-robbingour-future-by-under-investing-in-our-children/#775efbac5eaf [https://perma.cc/u8cj-c9sv]. 106. san antonio indep. sch. dist. et al. v. rodriguez, 411 u.s. 1, 24 (1973). 107. king & gaudiano, supra note 98. 108. darling-hammond, supra note 105. 168 indiana health law review [vol. 19:157 student poverty was higher than districts where there was little to no poverty.109 the “[m]ajority of nonwhite school districts receive an average of $23 billion less than predominately white school districts, despite serving roughly the same number of students [. . .].”110 in short, unequal funding creates an unequal education. 1. private schools in past economic recessions, enrollment numbers for private schools declined.111 during the great recession, from 2007 to 2011, enrollment in k-12 private schools decreased by 11%.112 while the expectations were that private school enrollment numbers would decline when covid-19 reached the united states, the opposite happened.113 of 160 private schools in over fifteen states and washington, d.c., about half reported higher enrollment in the new school year compared to the previous year.114 of those who reported enrollment staying the same, the majority reported that it was because their school was already at capacity.115 the biggest draw for private schools during the pandemic: in-person learning.116 of the same 160 private schools, 121 reported being open for fulltime, in-person learning, and the other thirty-nine reported being on a hybrid schedule, partly virtual and partly in-person – none reported being fully virtual.117 another study found that as of mid-october 2020, only 5% of private schools were fully online.118 with the money private schools receive from tuition, they generally have larger campuses but smaller class sizes.119 roughly 50.8 million students are enrolled in public schools, while only 5.8 million are enrolled in private schools.120 having larger campuses with smaller amounts of students coupled with greater autonomy, private schools could safely reopen.121 one study found that covid-19 infection rates among students, teachers, and education 109. id. 110. king & gaudiano, supra note 98. 111. damian kavanagh & benjamin scafidi, one sector is flourishing during the pandemic: k-12 private schools, hill (nov. 29, 2020, 8:00 a.m.), https://thehill.com/opinion/education/ 5 2 7 6 2 3 -on e-sec tor -is -f lou r ish ing-durin g-th e -pan dem ic-k-1 2 -pr iva t e -sch ools [https://perma.cc/858v-f993]. 112. id. 113. id. 114. id. 115. id. 116. id. 117. id. 118. jessica dickler, families jump to private schools as coronavirus drags on, cnbc (nov. 8, 2020, 9:45 am), https://www.cnbc.com/2020/11/08/coronavirus-why-families-arejumping-to-private-schools.html [https://perma.cc/3h3t-zrpx]. 119. id. 120. id. 121. id. 2022] virtual learning in a pandemic and its effect on lower-income students 169 staff were over 40% lower in private schools compared to public schools.122 however, the average cost of private schools across all grade levels is $26,866 per year123 and only about 5% of low-income students attend private schools nationally.124 so while children returning to in-person is ideal for parents who need to return to work after leaving their jobs when their children began learning virtually, private school is not an option for most.125 c. effects of low-income children not attending school in-person 1. food insecurity while the concerns for low-income students’ access to learning were warranted and prominent, even more so was a concern for their access to food.126 “among low-income households with children who qualify for free or reducedprice school meals, only about 15 [percent] [were] getting those meals [. . .].”127 a recent study showed that 17.4% of mothers with children ages twelve and under reported that since the pandemic started, the children in the home were not eating enough due to being unable to afford food, compared to only 7.4% in 2018.128 “food insecurity households with children under eighteen . . . increased by about 130 percent from 2018 to [may 2020].”129 many school districts tried their best to still get meals to students during the pandemic by offering curbside grab-and-go or running delivery routes.130 even with alternative options for students, many still missed meals.131 of a survey conducted in the spring of 2020, 80% of school districts said they were serving less meals than when school was 122. kavanagh & scafidi, supra note 111. 123. dickler, supra note 118. 124. matt barnum, fight over private school aid ends in defeat for betsy devos, chalkbeat (sept. 25, 2020, 4:27 pm), https://www.chalkbeat.org/2020/9/25/21456591/devosprivate-school-aid-cares [https://perma.cc/pg4c-xexu]. 125. dickler, supra note 118. 126. cory turner, ‘children are going hungry’: why schools are struggling to feed students, npr (sept. 8, 2020, 5:00 am), https://www.npr.org/2020/09/08/908442609/children-aregoing-hungry-why-schools-are-struggling-to-feed-students [https://perma.cc/nxy3-sd4v]. 127. id. 128. lauren bauer, the covid-19 crisis has already left too many children hungry in america, brookings (may 6, 2020), https://www.brookings.edu/blog/up-front/2020/05/06/thecovid-19-crisis-has-already-left-too-many-children-hungry-in-america/ [https://perma.cc/4uryw3wq]. 129. id. 130. rachel sugar, the scramble to feed the kids left hungry by the coronavirus crisis, vox (apr. 17, 2020, 8:00 am), https://www.vox.com/the-goods/2020/4/17/21220016/schoollunch-coronavirus-meal-programs[https://perma.cc/y4py-754s]. 131. turner, supra note 126. 170 indiana health law review [vol. 19:157 in session.132 the “majority of districts said the number of meals had dropped by 50 [percent] or more.”133 however, president trump enacted the families first coronavirus response act (“the act”) on march 18, 2020.134 included in the act was $1 billion in nutrition assistance.135 the act specifically allotted $400 million for the emergency food assistance program and allowed for flexibility in federal nutrition programs, including school meals and the supplemental nutrition assistance program (“snap”).136 “federal nutrition programs like snap – the first line of defense against hunger for millions of people who are low-income – will be the cornerstone to ensuring that people facing hunger are able to get the food they need during this pandemic [. . .].”137 even with efforts from school officials and additional snap funding, students were still missing meals while being out of school. 2. reports of child abuse teachers are the leading reporters of suspected abuse by noticing bruises, hunger, and mistreatment.138 in 2018, about 67% of reports of child abuse to the child protective services hotline came from professionals, such as teachers, pediatricians, and daycare providers.139 about 20% came from teachers and other educational personnel, specifically.140 due to virtual learning, teachers rarely saw their students in-person.141 the number of reported cases of abuse in forty-three states and washington, d.c. in april 2020 dropped by an average of 40.6% compared to april 2019.142 since covid-19 began in the united states, child 132. id. 133. id. 134. see families first coronavirus response act, pub. l. no. 116-127, 134 stat. 178 (2020). 135. press release, kate leone, chief government relations office, feeding america on senate passage of the families first coronavirus response act (mar. 18, 2020), https://www.feedingamerica.org/about-us/press-room/feeding-america-senate-passage-familiesfirst-coronavirus-response-act [https://perma.cc/86nh-db6p]. 136. id. 137. id. 138. nikita stewart, child abuse cases drop 51 percent. the authorities are very worried, n.y. times, https://www.nytimes.com/2020/06/09/nyregion/coronavirus-nyc-child-abuse.html [https://perma.cc/h4la-ptxn] (last updated aug. 7, 2020). 139. morgan welch & ron haskins, what covid-19 means for america’s child welfare system, brookings (apr. 30, 2020), https://www.brookings.edu/research/what-covid-19-meansfor-americas-child-welfare-system/ [https://perma.cc/cg46-c4vt]. 140. id. 141. stewart, supra note 138. 142. julia ingram, has child abuse surged under covid-19? despite alarming stories from ers, there’s no answer, nbc news, https://www.nbcnews.com/health/kids-health/has-childabuse-surged-under-covid-19-despite-alarming-stories-n1234713 [https://perma.cc/ss2a-aa5m] (last updated july 27, 2020). 2022] virtual learning in a pandemic and its effect on lower-income students 171 abuse cases in new york city declined by 51%,143 62% in washington, d.c.,144 and 55% in massachusetts.145 other states such as wisconsin, oregon, pennsylvania, and illinois reported child abuse reports fell by 20-70% in march 2020.146 states were forced to rely on the general public to report child abuse when suspected; however, in 2018, only about 16% of reports came from nonprofessionals such as friends, neighbors, and relatives.147 police, prosecutors, and child protection officials view the decline as an “unseen epidemic of abuse . . . spreading behind locked doors.”148 parents forced into isolation combined with lost jobs due to covid-19 causes tensions to build up and turn into violence,149 as economic downturns are generally associated with increases in child maltreatment.150 “[a] study from previous financial recessions, natural disasters, and outbreaks like the ebola outbreak in west africa from 2014-16, revealed increased rates of child abuse, neglect, and exploitation.”151 in one county in china, reports of domestic violence more than tripled during their february 2020 lockdown.152 furthermore, “sexual predators . . . [had] all-day access to children who would normally be in school [. . .].”153 since covid-19 began, sexual abuse has been the most common type of arrest in the bronx in new york city.154 covid-19 also changed the way child advocates did their job since they were no longer permitted to enter homes in an attempt to avoid spreading the virus.155 home investigations, child-parents visits, mandatory court appearances, and home-based parenting programs were paused or conducted virtually, making it harder for child welfare workers to ensure the safety of the children they work with.156 in some states, including michigan and kentucky, in-home visits were drastically scaled back to protect child welfare workers and help slow the spread 143. stewart, supra note 138. 144. samantha schmidt & hannah natanson, with kids stuck at home, er doctors see more severe cases of child abuse, wash. post (apr. 30, 2020, 7:00 am), https://www.washingtonpost. com/education/2020/04/30/child-abuse-reports-coronavirus/ [https://perma.cc/3p2s-ddry]. 145. paul leblanc, child abuse reports are down during the pandemic. experts say that’s a bad sign, cnn politics (may 17, 2020, 1:30 pm), https://www.cnn.com/2020/05/17/politics/ child-abuse-pandemic/index.html [https://perma.cc/wzb7-cwv7]. 146. welch & haskins, supra note 139. 147. id. 148. stewart, supra note 138. 149. id. 150. welch & haskins, supra note 139. 151. nazish imran et al., mental health considerations for children & adolescents in covid-19 pandemic, 36 pak. j. med. sci. s67, s67-s72 (2020). 152. id. 153. stewart, supra note 138. 154. id. 155. id. 156. welch & haskins, supra note 139. 172 indiana health law review [vol. 19:157 of covid-19.157 michigan in particular reduced in-home visits by 80%.158 faceto-face visits with children and being able to see them in their home environment are vital parts of the child welfare system. not being able to conduct them makes the system less effective.159 3. physical and mental health online learning also took away a child’s access to physical activity.160 when children are attending school, they generally are exposed to physical activity through recess, physical education classes, walking to and from school or the bus stop, and participating in school sports teams or clubs.161 the recommendation for children ages six to seventeen years old is sixty minutes or more of moderate-tovigorous physical activity each day.162 physical activity helps keep children healthy, but it also improves their performance academically.163 “students who are physically active tend to have better grades, school attendance, cognitive performance (e.g., memory), and classroom behaviors (e.g., on-task behavior).”164 even before the pandemic, children from low-income communities generally had a harder time accessing physical activity.165 children from low-income communities lack affordable options, experience safety concerns, lack parental support, and lack a neighborhood environment that fosters play and physical activity.166 children in low-income communities also generally do not have private backyards or public spaces to play in and are therefore stuck inside, eliminating their ability to engage in physical activities.167 for most low-income students, attending school is the only access they may have to physical activity, and if attending virtually, physical activity is severely limited. while attending school is important for children to learn various subjects, it is equally as important for children to attend school to learn social and emotional skills.168 when children attend school from home, they are not learning certain 157. id. 158. alysia burgio, child protective services still protecting kids despite covid-19 crisis, nbc news (apr. 1, 2020), https://nbc25news.com/news/coronavirus/child-protective-services-stillprotecting-kids-despite-covid-19-crisis [https://perma.cc/8nlk-6gn7]. 159. welch & haskins, supra note 139. 160. katelyn esmonde & keshia pollack porter, distance learning means kids are missing out on exercise, cbs news (oct. 20, 2020, 10:34 am), https://www.cbsnews.com/news/distancelearning-children-exercise-low-income-communities/ [https://perma.cc/txg8-89ky]. 161. id. 162. physical activity facts, ctr. for disease control & prevention (nov. 8, 2020), https://www.cdc.gov/healthyschools/physicalactivity/facts.htm [https://perma.cc/utv5-3kcn]. 163. id. 164. id. 165. esmonde & porter, supra note 160. 166. id. 167. id. 168. press release, emma garcía & elaine weiss, econ. pol’y inst., covid-19 and student 2022] virtual learning in a pandemic and its effect on lower-income students 173 social skills which typically develop through personal relationships among students and teachers.169 interacting with other children provides an opportunity to learn and practice social skills, and the immediate feedback they receive from other children allows them to evaluate how effective their behaviors are.170 “[s]ocial competence is primarily acquired in the play activities and social interactions with other children and youths.”171 peers play an essential role in a child’s social development, and engaging in positive interactions is essential to the social development of children.172 per psychologist erik erikson’s eight stages of psychosocial development, the fifth stage, identity versus role confusion, happens between ages twelve and nineteen.173 the most important event during this stage of development is social relationships.174 those who lack positive social skills are more likely to perform poorly academically and drop of out of school.175 furthermore, public health emergencies, e.g., pandemics, can affect a child’s mental health.176 “children are particularly vulnerable because of their limited understanding of the event.”177 a study conducted in china on children and adolescents showed clinginess, distraction, irritability, and a fear that family members could contract covid-19 since the pandemic began.178 closure of schools and separation from friends coupled with exposure to mass media coverage can cause mental distress among children.179 4. class engagement about half of all united states students attended school virtually for the 2020-2021 school year.180 due to a lack of resources, class preparedness also performance, equity, and u.s. education policy (sept. 10, 2020), https://www.epi.org/publication/ the-consequences-of-the-covid-19-pandemic-for-education-performance-and-equity-in-the-unitedstates-what-can-we-learn-from-pre-pandemic-research-to-inform-relief-recovery-and-rebuilding/ [https://perma.cc/xx5a-eefp]. 169. id. 170. juanita b. hepler, social development of children: the role of peers, 19 child. & sch. 242, 244 (1997). 171. id. 172. id. 173. imran et al., supra note 151. 174. id. 175. hepler, supra note 170. 176. imran et al., supra note 151. 177. id. 178. id. 179. id. 180. erin richards, students are falling behind in online school. where’s the covid-19 ‘disaster plan’ to catch them up?, usa today, https://www.usatoday.com/in-depth/news/ education/2020/12/13/covid-online-school-tutoring-plan/6334907002/ [https://perma.cc/cfw9fn9l] (last updated dec. 17, 2020). 174 indiana health law review [vol. 19:157 lacked.181 class failure rates significantly increased; fewer kindergarteners met early literacy targets in washington, d.c.; and math achievement levels dropped nationwide.182 in schools with high poverty rates, one in three teachers reported their students were significantly less prepared for grade-level work during the 2020-2021 school year compared with the previous year.183 when schools first closed in march 2020, a majority of teachers said that fewer than half their students were attending.184 the problem continued into the new school year, as was the case in detroit, michigan, where learning was being done virtually and only 78% of students showed up for class.185 tens of thousands of students nationwide were unaccounted for altogether.186 d. effects on low-income parents while the pandemic greatly affected children, it also greatly affected their parents. since the pandemic began, one in four adults had trouble paying their bills, a third of adults had to dip into savings or retirement accounts, and one in six had to borrow money from friends or family or had gotten food from a food bank.187 particularly among lower-income adults, “46 [percent] say they . . . had trouble paying their bills since the pandemic started and roughly one third say it [was] hard for them to make rent or mortgage payments.”188 of the 25% of u.s. adults who said they or someone in their household was laid off or lost their job from the pandemic, lower-income adults and young adults were the most likely.189 “lower-income adults who lost their job because of the coronavirus outbreak are more likely than those with middle or upper incomes to remain unemployed.”190 once the pandemic reached the united states, governors nationwide closed businesses, allowing only “essential” businesses to stay open, such as health care, food service, and public transportation.191 nearly 70% of essential workers do not 181. id. 182. id. 183. id. 184. abby goodnough, as schools go remote, finding ‘lost’ students gets harder, n.y. times (sept. 22, 2020), https://www.nytimes.com/2020/09/22/us/schools-covid-attendance.html [https://perma.cc/jc6r-rdjs]. 185. id. 186. richards, supra note 180. 187. kim parker et al., economic fallout from covid-19 continues to hit lower-income americans the hardest, pew rsch. ctr. (sept. 24, 2020), https://www.pewresearch.org/socialtrends/2020/09/24/economic-fallout-from-covid-19-continues-to-hit-lower-income-americans-thehardest/ [https://perma.cc/yn9p-gaf5]. 188. id. 189. id. 190. id. 191. celine mcnicholas & margaret poydock, who are essential workers?, econ. pol’y inst. (may 19, 2020, 11:25 am), https://www.epi.org/blog/who-are-essential-workers-acomprehensive-look-at-their-wages-demographics-and-unionization-rates/ [https://perma.cc/a5ev2022] virtual learning in a pandemic and its effect on lower-income students 175 have a college degree and one in ten have less than a high school diploma.192 nearly half of americans in low-wage jobs are essential workers, with a median wage of less than fifteen dollars an hour.193 with essential workers being made up of low-income workers and schools closed nationwide, parents struggled to find childcare.194 while many parents were able to switch to work-from-home and thus able to look after their children, nearly 60% of parents said their jobs could not be done remotely.195 with most child care providers closing their doors due to the pandemic or only allowing a reduced number of children, parents were forced to rely on family and friends or miss work entirely.196 one mother reported leaving her first-grader home alone with the neighbor occasionally checking in, another reported setting up a webcam to watch her teenage son while she worked, and another reported relying on her adult child to help.197 those who could not find adequate childcare or did not have family or friends to rely on had to either reduce their working hours or leave the workforce all together.198 of a study conducted from may 2020 to june 2020, more than 13% of adults had lost a job or reduced their hours due to lack of childcare.199 while women make up about half of all essential workers,200 they were more likely than men to leave their jobs because of lack of child care.201 “one out of four women who reported becoming unemployed during the pandemic said it was because of a lack of child care – twice the rate among men.”202 women of color, women without a college degree, and women living in low-income households reported gwty]. 192. id. 193. molly kinder & laura stateler, essential workers comprise about half of all workers in low-paid occupations. they deserve a $15 minimum wage, brookings (feb. 5, 2021), https://www.brookings.edu/blog/the-avenue/2021/02/05/essential-workers-deserve-minimum-wageincrease/ [https://perma.cc/e6fy-5acn]. 194. olga khazan & adam harris, what are parents supposed to do with their kids?, atlantic (sept. 3, 2020), https://www.theatlantic.com/politics/archive/2020/09/limited-child-careoptions-essential-workers/615931/ [https://perma.cc/28vt-wtbl]. 195. ruth igielnik, a rising share of working parents in the u.s. say it’s been difficult to handle child care during the pandemic, pew rsch. ctr. (jan. 26, 2021), https://www. pewresearch.org/fact-tank/2021/01/26/a-rising-share-of-working-parents-in-the-u-s-say-its-beendifficult-to-handle-child-care-during-the-pandemic/ [https://perma.cc/2t99-zm8c]. 196. khazan & harris, supra note 194. 197. id. 198. alicia sasser modestino, coronavirus child-care crisis will set women back a generation, wash. post (july 29, 2020, 7:00 am), https://www.washingtonpost.com/us-policy/ 2020/07/29/childcare-remote-learning-women-employment/ [https://perma.cc/k74v-qkrd]. 199. id. 200. mcnicholas & poydock, supra note 191. 201. modestino, supra note 198. 202. id. 176 indiana health law review [vol. 19:157 higher loss of hours among working parents.203 in september 2020 alone, 865,000 women left the workforce in the united states, which was four times more than men.204 this could affect women in the workforce for years to come, as women who leave the workforce to care for their children experience trouble getting back in.205 e. state by state since there was no federal regulation on how states should approach reopening schools, governors were to decide on a state-by-state basis how and when they would reopen schools.206 states had the option to order schools to reopen in the fall, order them to remain closed, or allow each school district to decide for themselves what they felt was proper given the community’s number of covid-19 cases and safety resources available.207 the majority of states chose to allow their school districts to make their own decisions.208 florida, along with arkansas, iowa, and texas, required schools to reopen in the fall, and washington, d.c. ordered full closure for at least the first semester.209 while some states ordered partial closure – school closures in certain cities with high numbers of covid-19 cases – there were no statewide closures.210 indiana was among those who left the decision in the hands of each school district.211 new york city started the school year remotely, switched to in-person classes, then back to remote learning, which was quickly reversed again.212 new york is now back to in-person learning.213 chicago, which had utilized remote learning since the shutdown in march 2020, sent its students back in-person with no real updates nor a plan in place concerning the safety of students and staff.214 after huge push203. id. 204. pallavi gogoi, stuck-at-home moms: the pandemic’s devasting toll on women, npr (oct. 28, 2020, 7:01 am), https://www.npr.org/2020/10/28/928253674/stuck-at-home-moms-thepandemics-devastating-toll-on-women [https://perma.cc/v55r-r27u]. 205. modestino, supra note 198. 206. where schools are reopening in the us, cnn, https://www.cnn.com/interactive/2020/ health/coronavirus-schools-reopening/ [https://perma.cc/vr26-dm52] (last visited nov. 8, 2020). 207. id. 208. where schools are reopening in the us, supra note 206. 209. id. 210. id. 211. id. 212. eliza shapiro, n.y.c. to reopen middle schools, but most students will still learn from home, n.y. times (feb. 8, 2021), https://www.nytimes.com/2021/02/08/nyregion/nyc-middleschools-reopening.html [https://perma.cc/998m-vzx7]. 213. id. 214. hannah leone et al., mayor lori lightfoot: chicago public schools and the teachers union reach a tentative reopening deal ‘at long last’, chi. trib. (feb. 7, 2021), https://www. chicagotribune.com/coronavirus/ct-chicago-public-schools-teachers-union-deal-reached-no-strike20210207-riflckhjwnfjfil5ddvbdfr75y-story.html? [https://perma.cc/lbj2-jlt5]. 2022] virtual learning in a pandemic and its effect on lower-income students 177 back from the chicago teachers union, a plan was eventually put in place, albeit still not ideal.215 1. florida ordered to reopen florida was one of only four states required to reopen for the start of the fall semester of the 2020-2021 school year.216 governor desantis issued an executive order requiring all brick-and-mortar schools to be open at least five days a week by august 31, 2020.217 the order was brought to court and the trial court judge issued an injunction on the executive order.218 however, on august 28, 2020, a florida state appellate court issued a stay of the trial judge’s injunction, “putting the state’s emergency order back in place.”219 florida also allowed each school district to decide whether or not masks would be required among students and faculty, and while some chose to require masks, many did not.220 one month into reopening schools, the infections among school-aged children jumped by 34%. despite florida being third in the number of reported covid-19 cases and fifth in total deaths at the time,221 governor desantis said they would not be closing schools.222 florida was allotted approximately $173.5 million as part of the governor’s emergency education relief (“geer”) fund.223 per florida’s geer application to the united states department of education, they planned on combining their geer funds and funds they received from the emergency and secondary school emergency relief (“esser”) fund to “encourage school districts to invest in initiatives that close achievement gaps and ensure access to high-quality learning opportunities” in k-12 education.224 florida intended to spend their money on: a 215. id. 216. where schools are reopening in the us, supra note 206. 217. id. 218. id. 219. id. 220. lori rozsa & valerie strauss, coronavirus case spike among school-age children in florida, while state orders some counties to keep data hidden, wash. post (sept. 9, 2020, 8:12 pm), https://www.washingtonpost.com/local/education/florida-coronavirus-schools/2020/ 09/08/711fa780-eee4-11ea-ab4e-581edb849379_story.html [https://perma.cc/x2ur-9ege]. 221. corky siemaszko, florida students head back to class amid reports of more kids catching covid-19, nbc news (aug. 31, 2020, 2:32 pm), https://www.nbcnews.com/news/usnews/florida-students-head-back-class-amid-pandemic-reports-more-kids-n1238888 [https://perma.cc/3pc2-uvcw]. 222. tony pipitone, no matter what, governor says, florida schools will stay open, nbc news so. fla., https://www.nbcmiami.com/news/local/no-matter-what-governor-says-floridaschools-will-stay-open/2309556/ [https://perma.cc/7x42-825s] (last updated oct. 20, 2020). 223. geer fund utilization, hunt inst., https://hunt-institute.org/covid-19-resources/geerfund-utilization/ [https://perma.cc/4nxs-x4hb] (last visited mar. 29, 2020). 224. id. 178 indiana health law review [vol. 19:157 summer recovery program, career and technical education (“cte”) equipment, ensuring the “b.e.s.t.” curriculum for reading and civics, telehealth, additional strategies to support summer learning, and civic literacy.225 the summer recovery program, which was designated $64 million, would require schools to target students with significant academic needs for four to six weeks of face-to-face learning over the summer months.226 $10.9 million was designated toward cte equipment, which schools could apply for through a grant program, awarding $55,000 per district and an additional $10,000 per k-12 school.227 ensuring the b.e.s.t. curriculum for reading and civics was allotted $4 million of geer funds and $20 million of esser funds “to help districts and schools identify and adopt b.e.s.t. ela standards aligned curriculum and supplemental instructional materials for k-3.”228 telehealth was allotted $2 million to provide mini-grants to all local educational agencies (“leas”) to help deploy telehealth throughout florida.229 additional strategies to support summer learning, granted $1 million, was to provide mini-grants to reinforce reading and math skills.230 lastly, civic literacy was allotted $1 million and would provide “matching grants for leas that voluntarily administer the florida civics hs exam.”231 florida was also allotted $2.8 billion for local school districts from the crrsa and $6.3 billion from the american rescue plan.232 2. indiana left the decision in the hands of each school district the state of indiana allowed school districts to make their own decision on whether or not to reopen in the fall.233 when making their decision, schools were instructed to use the color-coded map created by state health officials, which indicated the level of community spread in each county.234 governor holcomb mandated wearing masks in schools for staff, teachers, and students in third grade and above.235 school districts made their decision by talking with parents, students, and teachers, and were in contact with health officials.236 they considered various elements involved with returning to in-person including 225. id. 226. id. 227. id. 228. id. 229. id. 230. id. 231. id. 232. jordan, supra note 75. 233. where schools are reopening in the us, supra note 206. 234. id. 235. mj slaby, how districts in central indiana decided what to do for the coming school year, indystar, https://www.indystar.com/story/news/education/2020/07/29/education-indianahow-districts-decided-reopening-plans/5492909002/ [https://perma.cc/4zu8-pmzm] (last updated july 29, 2020). 236. id. 2022] virtual learning in a pandemic and its effect on lower-income students 179 transportation, staffing, scheduling, costs, class size, personal protective equipment, cleaning protocols, social distancing, and proper protocol in the case of a positive test.237 most areas in indiana offered an all-virtual option and an inperson option for families, although some districts did a hybrid schedule for middle and high school students.238 indiana was allotted approximately $61.5 million of the geer fund.239 per indiana’s application to the geer fund, they planned to use the funding to improve remote learning for all students through device availability, internet connectivity, and training.240 indiana intended to improve device availability and internet connectivity by creating a “flexible matching fund for community-level technology grants.”241 they planned to improve training and instructional materials through innovation grants to “create regional or statewide initiatives advancing/developing best practices, training, and curriculum for online . . . instruction.”242 governor holcomb’s senior advisor stated that $49.8 million of the geer funds went to devices and connectivity for k-12 schools, including “more than 68,000 student devices, nearly 2,900 teacher devices, and more than 85,800 mobile wi-fi devices along with subscription plans.”243 indiana was allotted approximately $799 million for local school districts from the crrsa and $1.7 million from the american rescue plan.244 despite indiana allowing school districts the freedom to make their own decisions, cases of covid-19 among students began to rise.245 once indiana students returned to in-person learning in the fall, 3,507 students, 719 teachers, and 801 staff members tested positive for covid-19.246 due to indiana’s rise in numbers, several school districts chose to revert to online schooling.247 3. washington, d.c. ordered to stay closed opposite of florida, washington, d.c.’s mayor bowser announced that the district of columbia public schools would remain closed with distance learning 237. id. 238. id. 239. geer fund utilization, supra note 223. 240. id. 241. id. 242. id. 243. slaby, supra note 235. 244. jordan, supra note 75. 245. arika herron, school leaders say they need help to keep indiana classrooms open as covid-19 numbers rise, indystar (oct. 30, 2020, 5:01 am), https://www.indystar.com/story/ news/education/2020/10/30/indiana-schools-need-help-keep-classrooms-open-covid-19-casesrise/6074802002/ [https://perma.cc/e7zx-km6r]. 246. id. 247. id. 180 indiana health law review [vol. 19:157 for at least the first term of the 2020-2021 school year.248 however, thirteen public school principals submitted proposals to reopen in small groups.249 these schools volunteered to reopen and did not force staff members to return.250 parents were allowed to walk through the school buildings to see the safety features that were implemented.251 after many false start dates, all other public schools finally reopened on february 1, 2021 in washington, d.c..252 staggered arrival times, small cohorts, mask mandates, and strict physical distancing measures were among the safety measures put in place to protect students and staff.253 washington, d.c. was allotted approximately $5.8 million as part of the geer fund.254 per the district of columbia’s geer application, they planned to use funds towards technology and social-emotional learning.255 washington, d.c. wanted to “ensure parents and students can access distance learning and that schools provide effective interventions and targeted supports for special populations.”256 they planned to accomplish this through grants to leas and third-party organizations “to support basic response costs (e.g., 1:1 devices, hot spots) and/or innovative models (e.g., distance learning infrastructure, blended learning strategies).”257 they also planned to use funds to “support school safety and promote the mental health of students, families, and educators.”258 washington, d.c. also spent $34 million, mostly federal funding, on building updates to ensure a safe environment for students and education staff.259 they were also allotted approximately $154.8 million from the crrsa and $347.6 million from the american rescue plan.260 on september 8, 2020, mayor bowser of washington, d.c. announced the launch of the $3.3 million internet for all initiative “to provide free internet access for up to 25,000 disconnected low-income students and families from d.c. 248. where schools are reopening in the us, supra note 206. 249. perry stein, some students will be able to return to d.c. public school buildings this week, wash. post (sept. 28, 2020, 2:10 pm), https://www.washingtonpost.com/local/education/ some-students-wil l-be -ab le -to -r e tu rn -to -dc-public-school-buildings-th is-week/ 2020/09/28/f5ecb130-0198-11eb-b7ed-141dd88560ea_story.html [https://perma.cc/9nla-65h6]. 250. id. 251. id. 252. id. 253. id. 254. geer fund utilization, supra note 223. 255. id. 256. id. 257. id. 258. id. 259. perry stein et al., after months of planning, protests and false starts, d.c. students and teachers head to classes for the first time in nearly a year, wash. post (feb. 2, 2021, 5:33 pm), https://www.washingtonpost.com/local/education/dc-schools-reopening/2021/02/02/29bfe1c4 -6514-11eb-8468-21bc48f07fe5_story.html [https://perma.cc/cqa4-2j6s]. 260. jordan, supra note 75. 2022] virtual learning in a pandemic and its effect on lower-income students 181 public schools and public charter schools.”261 the partnership launched the new tech together initiative by the office of the chief technology officer, which is “a partnership between public, private, and nonprofit sectors to bridge the digital divide in the district through increasing access to internet service, increasing access to internet-enabled devices and it support, demystifying technology through awareness, training and access to opportunities, and increasing technology savviness within d.c. government.”262 4. new york city, new york similar to indiana, the state of new york left the decision about whether schools would be opened or closed in the hands of local school district officials.263 however, schools were required to close if the in-school covid-19 positivity rate was higher than 9%, a threshold the state set in the summer of 2020.264 although, in new york city specifically, home to the nation’s largest public school system, that threshold was lowered to 3%.265 in october 2020, mayor de blasio reopened schools in new york city for all grade levelssix weeks later, he closed schools again as cases in new york city began to rise.266 mayor de blasio then reversed his decision to close schools and reopened them for elementary school students and children with advanced disabilities, with middle school students being able to return soon after.267 by reopening schools, the city’s 3% positivity rate threshold was disregarded, as the average positivity rate in new york city is around 8%.268 however, only students who chose to attend in-person at the beginning of the school year were allowed to return.269 those who initially opted out of in-person learning, roughly 70% of new york city students, remained online, most of whom were black, latino, and asian-american.270 “many black families in particular have said they are distrustful of school districts, and do not believe that their children will be safe in classrooms.”271 however, the city did have safety measures in place for staff and students in schools, including random weekly testing and requiring 261. press release, executive office of mayor muriel bowser, mayor bowser announces $3.3 million investment to provide home internet to low income dc students (sept. 8, 2020), https://mayor.dc.gov/release/mayor-bowser-announces-33-million-investment-provide-homeinternet-low-income-dc-students [https://perma.cc/j4ce-h6th]. 262. id. 263. where schools are reopening in the us, supra note 206. 264. id. 265. shapiro, supra note 212. 266. id. 267. id. 268. id. 269. id. 270. id. 271. id. 182 indiana health law review [vol. 19:157 schools to close temporarily if they had at least two unrelated positive cases.272 mayor de blasio referred to schools as the safest places in new york city.273 the state of new york received approximately $164.3 million as part of the geer fund, $3.6 billion from the crrsa, and $8 billion from the american rescue plan.274 in their application, new york vowed to use the funds to support k-12 education technologically.275 5. chicago, illinois chicago public schools (“cps”), the nation’s third largest public school system, the chicago teachers union (“ctu”), and mayor lightfoot were in contentious discussions since schools closed in march 2020 on how to reopen schools, which were still closed to in-person learning until march 2021.276 the ctu had concerns for the safety of themselves and the safety of their students, as “the city had a $3 billion backlog of facilities repairs on its aging school buildings . . . and teachers were concerned that poorly ventilated classrooms could encourage the coronavirus to circulate.”277 tensions between cps, the clu, and mayor lightfoot came to a head when mayor lightfoot ordered pre-k and special education teachers to return to school on january 4, 2021.278 most teachers refused, given the unsafe environment, and were consequently “deemed absent without leave, locked out of their cps accounts, and denied pay.”279 a second wave of students were set to go back on february 1, 2021, which led union members to announce they would go on strike if more teachers were locked out for refusing to go back in-person.280 cps, the clu, and mayor lightfoot then came to an agreement on how and when to reopen schools safely after tense negotiations.281 still, not all members of the ctu were thrilled about the agreement and schools reopening.282 president of the ctu, jesse sharkey, stated, “this plan is not what any of us deserve,” and, “[t]he fact that [chicago public schools] could not delay reopening a few short weeks to ramp up vaccinations and preparations in schools is a disgrace.”283 the agreement addressed health and safety protocols in cps facilities, ventilation 272. id. 273. id. 274. jordan, supra note 75. 275. geer fund utilization, supra note 223. 276. leone et al., supra note 214. 277. moriah balingit, chicago reaches deal with teachers to reopen school buildings, wash. post (feb. 10, 2021, 4:52 pm), https://www.washingtonpost.com/education/2021/02/10/ chicago-teachers-pandemic/ [https://perma.cc/994u-samz]. 278. leone et al., supra note 214. 279. id. 280. id. 281. balingit, supra note 277. 282. id. 283. id. 2022] virtual learning in a pandemic and its effect on lower-income students 183 requirements, covid-19 testing, contact tracing, operational pauses, the creation of covid-19 committees, vaccination efforts, accommodations and staffing, when to return to in-person learning, technology for remote learning, and community support.284 the agreement stated that in-person learning would be paused for fourteen days and back fully remote if the covid-19 test positivity rate in chicago increased for seven consecutive days, the rate for each of seven consecutive days was at least 15% higher than the rate one week prior, and the rate on the seventh day was 10% or greater.285 classes would resume in-person on the fifteenth day, “or when the criteria for pausing in-person learning are no longer met, whichever is later.”286 6. vaccinating teachers in the united states on december 14, 2020, vaccines for the covid-19 virus were distributed nationwide, with front-line health-care workers being the first to receive it.287 although each state was to decide which groups of people qualify for the vaccine and in what order, they mostly followed the cdc’s recommendations.288 the cdc had separated its recommendations into three priority categories: 1a, 1b, and 1c.289 priority 1a included healthcare personnel and residents of long-term care facilities, priority 1b included frontline essential workers, including those who work in education, and people aged seventy-five and older, and priority 1c was people aged sixty-five to seventy-four, people aged sixteen to sixty-four with underlying medical conditions, and other essential workers.290 while the cdc recommended teachers be prioritized as 1b, ultimately states were to decide whether or not teachers were going to be prioritized, and initially only twenty-six states decided they would be.291 florida and indiana were among the states who did not initially prioritize teachers in getting the vaccine, while washington, d.c., 284. agreement between the chi. bd. of educ. & chi. tchr. union (feb. 6, 2021), https://www.ctulocal1.org/wp-content/uploads/2021/02/2.6.21-framework-for-resumption-of-inperson-instruction-side-letter.pdf [https://perma.cc/ay38-sfmn]. 285. id. 286. id. 287. ben guarino et al., ‘the weapon that will end the war’: first coronavirus vaccine shots given outside trials in u.s., wash. post (dec. 14, 2020, 5:50 pm), https://www. washingtonpost.com/nation/2020/12/14/first-covid-vaccines-new-york/ [https://perma.cc/x5zdhxdf]. 288. yon pomrenze et al., here are the states allowing teachers to get covid-19 vaccines, cnn, https://www.cnn.com/2021/02/05/us/teacher-vaccine-states-list-trnd/index.html [https:// perma.cc/2st9-r89s] (last updated feb. 17, 2021). 289. cdc’s covid-19 vaccine rollout recommendations, ctr. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations.html [https:// perma.cc/bpr7-zf8x] (last visited feb. 12, 2021). 290. id. 291. pomrenze et al., supra note 288. 184 indiana health law review [vol. 19:157 illinois, and new york were among those that did.292 in chicago, cps provided 1,500 vaccine doses each week to employees.293 as part of the agreement that the ctu fought for, no member would be required to work in person without having the option to be fully vaccinated294 and as of march 17, 2021, all cps employees had been offered that opportunity.295 on march 2, 2021, the u.s. department of health and human services issued a directive requiring all states to make teachers, school staff, and childcare workers eligible for the vaccine.296 those eligible included teachers and staff, licensed childcare providers, classroom aides, bus drivers, janitors, counselors, administration staff, cafeteria workers, and substitute teachers.297 furthermore, president biden instructed all states to open vaccine eligibility to all adults by may 1, 2021.298 f. the european approach to successfully reopening schools 1. germany european countries vowed to prioritize reopening, and maintaining the schools that are open.299 in germany, students were divided into different cohorts with specific teachers, and each cohort was prohibited from mixing with another cohort.300 students were required to wear masks while walking in the hallways and when entering classrooms but were allowed to take off their mask once they were seated at their desks.301 moreover, all classrooms were set up to allow for proper social distancing protocols and ventilation was improved throughout 292. id. 293. leone et al., supra note 214. 294. id. 295. staff covid-19 vaccination, chi. pub. sch., https://www.cps.edu/school-reopening/ health-and-safety/staff-covid-19-vaccination/ [https://perma.cc/cs45-qy8w] (last visited mar. 29, 2020). 296. covid-19 vaccines for teachers, school staff, & childcare workers, ctr. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/ specific-groups/teachers-childcare.html [https://perma.cc/nb8g-ts45] (last visited mar. 20, 2021). 297. id. 298. rachel treisman, nearly half of states will make all adults covid-19 vaccine eligible by april 15, npr (mar. 26, 2021, 3:42 pm), https://www.npr.org/sections/coronavirus-liveupdates/2021/03/26/981680704/nearly-half-of-states-will-make-all-adults-covid-19-vaccineeligible-by-april-15 [https://perma.cc/e4x4-md4x]; see also covid-19 vaccines for children and teens, ctr. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/ vaccines/recommendations/adolescents.html [https://perma.cc/6but-pskm] (last visited july 23, 2021) (children twelve and older are now eligible to receive the vaccine). 299. godin, supra note 33. 300. id. 301. id. 2022] virtual learning in a pandemic and its effect on lower-income students 185 schools.302 when schools first reopened in august 2020, after the initial lockdown in march, covid-19 cases started to rise among students and teachers.303 berlin reported at least 42 of their 825 schools that reopened had covid-19 cases within the first two weeks of reopening.304 however, given germany’s use of cohorts, “the country has not yet seen any major outbreaks or long-term school closures.”305 germany prioritized schools remaining open, even if other public venues had to be closed down to do so,306 including bars, restaurants, theaters, concert halls, gyms, and tattoo parlors.307 “the european center for disease prevention and control found that children accounted for less than 5 percent of all cases of coronavirus reported in the [twenty-seven] countries of the european union and britain . . . [finding] that school closures would be ‘unlikely to provide significant additional protection of children’s health.’”308 attendance to in-person school was generally required throughout europe and distance learning is no longer an option.309 2. spain in spain, schools reopened in september 2020, despite covid-19 cases rising across the country, using cohorts similar to germany.310 in catalonia, spain, where they had the resources to conduct tracing, “87 percent of initial cases in classrooms did not spread to another person” and of the 13% that did spread, most only spread to two or three other people in the school.311 for young age groups through twelve years old, most schools went on without interruption; however, some high schools switched to part-time or full-time remote learning due to infection and transmissions rates being seemingly higher for older students.312 schools in spain were committed to making in-person learning not only possible, but maintainable.313 one teacher in the spanish city of seville 302. id. 303. id. 304. id. 305. id. 306. id. 307. melissa eddy, why is europe keeping its schools open, despite new lockdowns?, n.y. times (oct. 29, 2020), https://www.nytimes.com/2020/10/29/world/europe/schools-coronaviruseurope-lockdowns.html [https://perma.cc/d37w-ha8w]. 308. id. 309. id. 310. michael birnbaum, europe’s schools still open, still relatively safe, through covid-19 second wave, wash. post (dec. 1, 2020, 5:32 pm), https://www.washingtonpost.com/world/ europe/europe-schools-covid-open/2020/12/01/4480a5c8-2e61-11eb-9dd6-2d017 9981719_story.html [https://perma.cc/dq5d-55km]. 311. id. 312. id. 313. id. 186 indiana health law review [vol. 19:157 bought a carbon dioxide monitor so she knew how much exhaled air was building up in the room.314 other measures taken among spanish schools included new windows to increase air flow, n95 masks for teachers, and switching from textbooks to chromebooks to make disinfecting materials easier.315 teachers were even given microphones to use when their voices became muffled from wearing masks, and even further, received voice lessons on how to better project their voices.316 3. switzerland officials in switzerland stood firm in two beliefs during the pandemic: children are not “drivers of the pandemic” and education is best served inperson.317 maintaining these beliefs resulted in switzerland schools, for the most part, remaining open.318 switzerland schools closed in march 2020 when the pandemic first struck, but successfully reopened in may 2020 until the end of the school year in july.319 students returned to in-person learning in the fall to start the new school year and have stayed open since.320 switzerland eased students back into in-person learning by splitting classrooms into two cohorts and alternating days of in-person and virtual learning for the first two weeks.321 then, all children under the age of sixteen started in-person learning every day.322 those over sixteen years old had the option to attend in-person in smaller class sizes or remain online.323 students twelve years and older were required to wear a mask and maintain physical distance.324 some schools had staggered start times for younger students to avoid large gatherings of parents and generally tried to keep students of different age groups separated.325 once schools were reopened in switzerland, covid-19 cases flattened and once school was dismissed for 314. id. 315. id. 316. id. 317. isobel leybold-johnson, swiss schools stay open as debate over virus spread continues, swi (nov. 19, 2020), https://www.swissinfo.ch/eng/swiss-schools-stay-open-as-debateover-virus-spread-continues/46166654 [https://perma.cc/8dxw-26d6]. 318. id. 319. ben mussett, switzerland and denmark may offer tips for successful return to school in b.c., cbc news (aug. 15, 2020, 11:00 am), https://www.cbc.ca/news/canada/british-columbia/ switzerland-denmark-school-reopening-plan-covid-19-1.5683975 [https://perma.cc/w3av-6l9t]. 320. isobel leybold-johnson, covid-19: school closures ‘could be an option’, swi (jan. 4, 2021), https://www.swissinfo.ch/eng/covid-19--school-closures--could-be-an-option-/46259914 [https://perma.cc/k6x8-qbrf]. 321. mussett, supra note 319. 322. id. 323. id. 324. id. 325. id. 2022] virtual learning in a pandemic and its effect on lower-income students 187 summer break in july 2020, cases began to rise again.326 swiss officials have stated that shutting down schools is a last resort.327 g. what can be done? determining what k-12 public schools should or should not be doing to ensure education continues during covid-19 was no small task. while reopening could have endangered the lives of children, the risk was extremely low. less than 10% of covid-19 cases in the united states have been among children aged five to seventeen.328 children who do contract covid-19 are likely to be asymptomatic or experience mild symptoms.329 while in-person learning had not been seen to increase the spread of covid-19,330 virtual learning had been seen to be detrimental to students. virtual learning leaves children in lowincome areas behind. all children are entitled to their right to education and covid-19 should not take that from them. although the cares act, the crrsa, and the american rescue plan cannot fix the years of disproportionate funding which led states into this position, it has the potential to ensure children are not further left behind due to covid-19. however, the u.s. education department has only approved seven of the thirty-nine state plans submitted for funds from the american rescue plan.331 education, like in european countries, should be a priority in the united states; however, it is not. for instance, while germany prioritized education by closing other public spaces,332 governors across the united states allowed bars and restaurants to reopen, still with no real plan on how to reopen schools on a larger scale.333 while schools remained online in the new school year, few had taken steps to make it more efficient. less than half of all school districts offered some sort of professional development over the summer for educators to learn more engaging ways to teach online.334 so, not only was there no plan on how to reopen schools safely, over six months into the pandemic, when students would normally return for a new school year, there still was no adequate training provided to teachers regarding virtual learning. wearing a mask and remaining socially distanced are practices that have been 326. id. 327. leybold-johnson, supra note 320. 328. science brief: transmission of sars-cov-2 in k-12 schools, ctr. for disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/ transmission_k_12_schools.html [https://perma.cc/6ww3-2j74] (last visited mar. 28, 2021). 329. id. 330. id. 331. jordan, supra note 75. 332. godin, supra note 33. 333. dana goldstein, lost summer: how schools missed a chance to fix remote learning, n.y. times (aug. 7, 2020), https://www.nytimes.com/2020/08/07/us/remote-learning-fall-2020. html [https://perma.cc/y3m8-8g56]. 334. id. 188 indiana health law review [vol. 19:157 effective, especially among children, where the risk of catching and transmitting covid-19 is already low.335 simple safety measures, i.e., wearing a mask and maintaining distance, coupled with students attending school in cohorts, as done in european countries,336 provides for a safe learning environment for students. it is an even safer environment for students and teachers when the ventilation systems have been improved.337 frequent testing among students and education staff and operational pauses, as seen in chicago,338 can also be effective. when these measures are not put into place, there will be outbreaks among students and education staff, as was seen in indiana.339 students cannot afford to remain learning online, especially those in lowincome areas. where schools are still online, representatives and senators should be providing resources to help their students access their education. representative ocasio-cortez of new york’s 14th congressional district, making up parts of the bronx and queens, instituted a “homework helper” program.340 the program provides free, one-on-one english and spanish speaking tutors, who have been vetted and trained, to students who need it;341 over 13,000 volunteers have signed up to tutor.342 governors could have prioritized their schools by focusing on a state-wide plan, rather than overwhelming local officials with the decision. when infectious rates were low among the community, schools were safe, but when rates rise in the community, it was seen to also rise within schools.343 when infectious rates rise, the focus should have been on keeping school districts open, rather than bars and restaurants. in a panic, schools understandably closed in the spring of 2020; however, over one year into the pandemic, it was unacceptable that there was not a realistic plan in place. the cdc has now declared reopening to in-person learning a priority for the 20212022 school year.344 335. annie grayer, schools are 2 months into reopening under covid-19 and no one’s officially keeping track of how it’s going, cnn, https://www.cnn.com/2020/10/12/us/schoolyear-start-in-pandemic-wellness/index.html [https://perma.cc/n25h-lc5k] (last updated oct. 12, 2020). 336. godin, supra note 33. 337. moriah balingit, are schools safe? a growing body of evidence suggests that, with the right measures, they contribute little to virus spread, wash. post (dec. 30, 2020, 6:00 am), https://www.washingtonpost.com/local/education/school-coronavirus-spread/2020/12/29/bbfac9d83697-11eb-a997-1f4c53d2a747_story.html [https://perma.cc/mq9e-uhns]. 338. agreement between the chi. bd. of educ. & chi. tchr. union, supra note 284. 339. herron, supra note 245. 340. cristian benavides, ocasio-cortez launches free virtual homework help program, pix 11, https://www.pix11.com/news/local-news/ocasio-cortez-launches-free-virtual-homework-helpprogram [https://perma.cc/r9f6-n4sz] (last updated dec. 15, 2020). 341. id. 342. homework helpers, alexandria ocasio cortez, https://act.ocasiocortez.com/signup/ homework-helpers/ [https://perma.cc/2z3w-exvc] (last visited feb. 17, 2021). 343. balingit, supra note 337. 344. guidance for covid-19 prevention in k-12 schools, ctr. for disease control & 2022] virtual learning in a pandemic and its effect on lower-income students 189 iv. conclusion online learning is only widening the education gap, and if states continue to leave low-income students behind, the effects will be irremediable. before the pandemic reached the united states, there was already a tremendous problem in access to education. education is a right for all students in the united states, yet even before the pandemic, students in low-income areas were already at a disadvantagethe spread of covid-19 has only exacerbated the issue. there were great disparities between the experiences of those in low-income areas versus those in affluent areas since virtual learning began in march 2020.345 virtual learning took away food security, stripped students of a safe haven, affected physical and mental health, and lowered class engagement in all students, but especially those students in low-income households. furthermore, because virtual learning forced students to learn from home, parents were put in an impossible position, having to choose between being home with their children and keeping their jobs346 a problem which affected women far more than men.347 although these times are unprecedented, keeping children at home cannot be the solution. a child’s right to education is in jeopardy nationwide, especially for those students who are low-income. it is crucial all students return to school inperson, and it is crucial they remain in school throughout the remainder of the pandemic. prevention, https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12guidance.html [https://perma.cc/fug8-udhp] (last visited july 23, 2021). 345. see generally esquivel et al., supra note 87. 346. see generally khazan & harris, supra note 194. 347. see generally gogoi, supra note 204. indiana health law review volume xviii 2021 number 2 notes minding baby: the link between maternal depression and infant health and development paige ferise* we have a secret in our culture, and it’s not that birth is painful. it’s that women are strong. – laura stavoe harm i. introduction in 2018, during the state of the state address, indiana governor, eric holcomb, declared that indiana would have the lowest infant mortality rate in the midwest by 2024.1 this was a lofty goal in light of indiana’s historically poor ranking in infant mortality.2 in the two years since governor holcomb made this promise, several steps have been taken to work towards caring for mothers’ and babies’ physical health, but very little has been done to address maternal mental health or maternal trauma.3 there is a genetic and cyclical nature to trauma that causes mothers and babies to be disproportionately affected. mothers who experience trauma in childhood are more likely to experience depression during or after pregnancy. similarly, infants born to mothers who experienced untreated depression are at a higher risk for childhood trauma. much of the policy surrounding maternal care focuses on important aspects of prenatal care such as physical health, but largely ignores mental health. maternal depression can have devastating effects on babies ranging from attachment disorders to developmental delays. left untreated, maternal depression can cause adverse health outcomes; not only for the mother but also for the baby. maternal mental health and trauma screenings during pregnancy and * j.d. & m.p.h candidate, 2022, indiana university robert h. mckinney school of law & fairbanks school of public health; b.a. 2017, butler university. 1. governor eric holcomb, 2018 state of the state address: the next steps to the next level (jan. 9, 2018), https://www.in.gov/gov/2972.htm [https://perma.cc/jsn3-ygnu]. 2. infant mortality, ind. u. sch. med., https://medicine.iu.edu/expertise/indiana-health/ infant-mortality [https://perma.cc/37du-f26l] (last visited mar. 28, 2021) [hereinafter ind. u. sch. med.]. 3. my health baby: indiana’s ob navigator program, ind. st. dep’t health, https://www.in.gov/isdh/28233.htm [https://perma.cc/g2av-brmm] (last visited mar. 28, 2021). 372 indiana health law review [vol. 18:371 postpartum should be the required standard of care for all medicaid mothers, or for all mothers who are not enrolled in medicaid, but whose child is medicaid eligible. screening for, and offering services to treat, maternal mental health disorders can reduce adverse outcomes for infants – including infant death – and end the epigenetic cycle of mental illness and toxic stress that is particularly rampant in low-income communities. a. road map this note will begin with an overview of the background of maternal mental health in the united states. section ii will first describe in detail what maternal depression is and how it affects both mothers and infants. this section will give a brief history of maternal mental health in the united states and where the country, as well as the state of indiana, currently stands in terms of maternal depression screenings. section ii will then draw a connection between maternal mental health and infant mortality. this section will delve into specifics on infant mortality in the united states as well as in the state of indiana. finally, section ii will discuss the concept of adverse childhood experiences (“aces”) and the role that these experiences play on maternal mental health and infant health. this section will define aces as well as toxic stress and draw connections between trauma and public health. in section iii, this note will present a full literature review. first, section iii will give a literature review of the connection between maternal depression and adverse outcomes in infant health. this portion will dive further into research about the severe effect that maternal mental health can have on infant mortality. next, section iii will provide a full review of the research regarding the generational effect of maternal mental health and trauma. this section will define the term epigenetics and will provide research on the generational effects of toxic stress and mental health disorders on pregnant women and mothers. finally, section iii will provide an overview of research connecting maternal aces and toxic stress with infant health outcomes. specifically, this section will present research that draws a connection between maternal trauma and infant mortality rates. section iv will give a policy review of different jurisdictions in the united states. this section will go over various policies that touch on maternal mental health screenings, maternal aces screenings, as well as billing and reimbursement policies. section iv will compare and contrast policies in states that are geographically near indiana or states that are also in the bottom ten nationally for infant mortality. this portion will also discuss where indiana currently stands on maternal mental health policies. finally, section v will give policy recommendations for the state of indiana. this portion will draw from other state policies and make a proposal for how indiana can change and improve policy so as to better care for the mental health of mothers, and in turn, reduce infant mortality. 2021] minding baby 373 ii. background a. maternal depression maternal depression describes a wide variety of perinatal4 mental health conditions that can affect women throughout their pregnancy and postpartum.5 prenatal depression is a mental health condition that occurs during pregnancy.6 it is estimated that ten to twenty percent of mothers experience prenatal depression.7 symptoms can include crying or weepiness, lack of appetite, loss of enjoyment of regular activities, or poor fetal attachment.8 often prenatal depression can also include severe anxiety about the health of the baby or of the mother herself.9 depression during pregnancy is the greatest indicator for postpartum depression and women who present with depressive symptoms during pregnancy should be tested again after the birth.10 studies have shown that “[n]early [seventy-three] percent of women who report antepartum depression also experience postpartum depression, compared to [thirty-eight] percent of women who did not experience antepartum depression but later experienced it postpartum.”11 prenatal depression is easy to misdiagnose and is often reduced to a mother simply being hormonal. antenatal depression can have significant health effects on both mom and baby.12 experienced by as much as eighty percent of new mothers, the most common form of maternal depression is referred to as “baby blues.”13 baby blues tend to 4. perinatal refers to the period of time directly before (approximately twenty-two completed weeks of gestation) and after the birth of a child (seven completed days postpartum). maternal and perinatal health, world health org., https://www.who.int/maternal_child_ adolescent/topics/maternal/maternal_perinatal/en/ [https://perma.cc/ltd4-bnme] (last visited mar. 28, 2021). 5. what is maternal depression?, n.y. st. dep’t health, https://www.health.ny.gov/ community/pregnancy/health_care/perinatal/maternal_depression/providers/what_is_maternial_ depression.htm [https://perma.cc/9t6r-2h4j] (last updated jan. 2015). 6. id. 7. see anne-claude bernard-bonnin, can. pediatric soc’y, maternal depression and child development, 9 paediatrics & child health 575, 575 (2004). 8. what is maternal depression?, supra note 5. 9. juli fraga, prenatal depression may be the most severe form of maternal depression, wash. post (aug. 29, 2016), https://www.washingtonpost.com/news/to-your-health/wp/2016/ 08 /29/prenatal-depression-may-be-the-most-severe-form-of-maternal-depression / [https://perma.cc/57yf-zedn]. 10. margaret wile, from pregnancy to postpartum: the effects of maternal depression on mothers, infants and toddlers 1 (2019), https://www.ncsl.org/ research/ human-services/from-pregnancy-to-postpartum-the-effects-of-maternal-depression-on-mothersinfants-and-toddlers.aspx [https://perma.cc/c4ej-bd9p]. 11. id. (footnote omitted). 12. fraga, supra note 9. 13. what is maternal depression?, supra note 5. 374 indiana health law review [vol. 18:371 begin “during the first few weeks after delivery” and typically last between one and two weeks.14 symptoms can include weepiness, anxiety, irritability, mood swings, insomnia, and an exaggerated sense of empathy.15 baby blues are categorized as the “least severe form of postpartum depression.”16 the american pregnancy association recommends self-care such as maintaining a healthy diet and keeping a journal of feelings and moods as a way to combat baby blues.17 it is also recommended that new mothers experiencing these symptoms find someone they trust to talk with and ask for help when they need it.18 postpartum depression is the form of maternal depression that is most commonly discussed in literature and policy. postpartum depression is categorized by a sense of more persistent sadness and is distinguishable from baby blues by the length of time the emotional distress lasts.19 symptoms of postpartum depression include many of the symptoms of baby blues but also can include more severe symptoms such as difficulty bonding with baby, recurrent thoughts of self-harm or harming the baby, panic attacks, feelings of worthlessness or hopelessness, and fear of being a bad mother.20 in recent years, postpartum depression has been recognized as a major public health issue globally.21 studies conducted in the united states, the united kingdom, and australia show that, on average, ten to fifteen percent of new mothers experience postpartum depression.22 treatment for postpartum depression can include pharmacological therapy, cognitive behavioral therapy, or both.23 the most severe form of maternal mental illness is called postpartum psychosis (“pp”).24 pp symptoms generally begin as early as two to three days after birth and can last between one and four weeks.25 pp is rare and occurs only in one to two mothers out of 1000.26 pp is characterized by hallucinations, paranoia, inability to perform simple tasks, obsessive thoughts about harming the 14. id. 15. id. 16. baby blues, am. pregnancy ass’n (jan. 25, 2019), https://americanpregnancy.org/firstyear-of-life/baby-blues/ [https://perma.cc/7cxs-2eza] 17. id. 18. id. 19. what is maternal depression?, supra note 5. 20. mayo clinic staff, postpartum depression, mayo clinic (sept. 1, 2018), https://www. mayoclinic.org/diseases-conditions/postpartum-depression/symptoms-causes/syc-20376617 [https://perma.cc/5eff-26td]. 21. see generally elizabeth fitelson et al., treatment of postpartum depression: clinical, psychological and pharmacological options, 3 int’l j. women’s health 1 (2010). 22. id. at 1. 23. id. at 3. 24. what is maternal depression?, supra note 5. 25. dorothy sit et al., a review of postpartum psychosis, 15 j. women’s health 352, 353 (2006). 26. id. 2021] minding baby 375 child, excessive energy or agitation, and confusion.27 overwhelming research has shown that pp is linked to bipolar disorder, schizoaffective disorder, or schizophrenia.28 women who have a personal or family history of one or more of the above disorders are at the highest risk for developing pp.29 this disorder requires immediate medical attention and treatment that often includes both medical intervention as well as cognitive and behavioral therapy.30 though any mother can experience depressive symptoms after the birth of any child, there are some risk factors that can make certain people predisposed to perinatal mental illness.31 those with a history of mental illness, both during pregnancy and prior to pregnancy, are more likely to experience some form of maternal mental illness.32 mothers who have a childhood trauma history (e.g., aces), particularly of sexual assault, are also more at risk for maternal depression.33 higher-risk pregnancies and traumatic deliveries are also related to a higher risk of developing depressive symptoms.34 age can be a risk factor and the highest rates of depression have been observed in young mothers aged thirteen to nineteen years old.35 perhaps the biggest risk factor for developing maternal depression is social isolation. the existence of a poor relationship with the father of the child, or a lack of support from other family members has been shown to have a significant effect on the development of depressive symptoms.36 “in addition to the [woman's] relationship with family members and [the] community, behaviors such as smoking during [the] prenatal period, [are] . . . social factors associated with increased incidence of postpartum depression a[t] 1.7 times.”37 finally, socioeconomic status, as well as education, play a role in the development of depressive symptoms.38 though each of the above-mentioned maternal mental illnesses is incredibly important in its own right, this note will focus largely on baby blues and postpartum depression due to the higher rate of occurrence of both conditions as well as the effect that they have on maternal and infant health. 27. id.; mayo clinic staff, supra note 20. 28. see sit et al., supra note 25; kimberly a. yonkers et al., management of bipolar disorder during pregnancy and the post-partum period, 161 am. j. psychiatry 608 (2004); ian brockington & antoine guedeney, motherhood and mental health, 2 infant observation 116 (1999). 29. yonkers et al., supra note 28. 30. mayo clinic staff, supra note 20. 31. what is maternal depression?, supra note 5. 32. id. 33. see maryam ghaedrahmati et al., postpartum depression risk factors: a narrative review, 6 j. ed. & health promotion art. 60 (2017). 34. see id. 35. id. at 16. 36. see id. at 23-24. 37. id. at 24 (footnote omitted). 38. id. 24-25. 376 indiana health law review [vol. 18:371 b. infant mortality infant mortality is defined as “the death of an infant before his or her first birthday.”39 the infant mortality rate is calculated as the number of infant deaths for every 1,000 live births, and there were 4.1 million infant deaths globally with an average mortality rate of twenty-nine deaths for every 1,000 live births.40 the highest average rate was in the africa region, as categorized by the world health organization (“who”).41 though infant death may seem to be a problem of the past for the global north, it continues to plague even the wealthiest nations. the infant mortality rate in the who europe region is eight deaths per 1,000 live births.42 the overall infant mortality rate in the united states is 5.8 deaths for every 1,000 live births.43 as with many other public health issues in the united states, infant death is not experienced equally throughout the country. new hampshire has the lowest rate of infant death with only 3.9 deaths per 1,000 births.44 mississippi has the highest rate of infant death with 9.1 deaths per 1,000 births.45 the disparity in infant deaths goes beyond geographic location. race plays a significant role in infant mortality with the average rate for african american infants being 10.9 per 1,000 births, nearly twice that of the national average.46 similarly, native american populations also experience considerably higher rates of infant death with the average in these populations being 8.4 per 1,000 births.47 this note will focus on infant death rates in indiana. of the fifty united states, indiana ranks forty-third for infant mortality, reporting 7.4 deaths per 1,000 live births in 2019.48 indiana’s infant death rate is more than twenty percent higher than the national average.49 in 2017, 601 infants died before their first birthday, and of those deaths, twenty-five percent occurred in just three percent 39. infant mortality, ctr. for disease control & prevention, https://www.cdc.gov/ reproductivehealth/maternalinfanthealth/infantmortality.htm [https://perma.cc/tjf2-589b] (last updated sept. 10, 2020) [hereinafter cdc]. 40. infant mortality, world health org., https://www.who.int/gho/child_health/mortality/ neonatal_infant_text/en/ [https://perma.cc/2vc9-g5bv] (last visited mar. 28, 2021). 41. id. the who categorizes its member states into six regions: african region, region of the americas, south-east asian region, european region, eastern mediterranean region, and western pacific region. 42. id. 43. cdc, supra note 39. 44. infant mortality, am. health rankings (2019), https://www.americashealthrankings. o r g / e x p lo r e / h e a l t h -o f -w o m e n -a n d -c h ildren /m easu re / imr _ mc h /s t a t e / al l [https://perma.cc/h5xk-fyu2] [hereinafter am. health rankings]. 45. id. 46. id. 47. id. 48. id. 49. ind. u. sch. med., supra note 2. 2021] minding baby 377 of the state’s zip codes.50 indiana also experiences extreme racial disparities in infant mortality. in 2017, the rate of infant death for african american babies in indiana was 12.5 per 1,000.51 in that same year, the rate for hispanic babies was 7.8 per 1,000 births.52 comparatively, the rate of infant death for white infants in indiana was only 6.1 per 1,000 births in 2017.53 there are several reasons why an infant may die before their first birthday. in 2017, the centers for disease control and prevention (“cdc”) ranked birth defects as the leading reason for infant death.54 the cdc did not provide an explanation as to what the most common birth defects were, or if the defects were genetic or due to prenatal risks taken by the mother. rounding out the top five, the causes of death that were identified by the cdc were preterm birth or low birth weight, maternal and pregnancy complications, sudden infant death syndrome (“sids”), and injuries such as suffocation.55 indiana categorizes its infant deaths into most the common causes. the largest number of infant deaths in indiana (forty-eight percent) is attributed to perinatal risks.56 perinatal risks can include mental health conditions as well as physical health conditions such as obesity, hypertension, diabetes, or heart disease.57 other perinatal risks can include tobacco use, alcohol use, or illicit drug use.58 the next highest percentage of infant deaths in indiana can be attributed to congenital malformations.59 the remainder of infant deaths in indiana is due to 50. id. 51. am. health rankings, supra note 44. 52. id. 53. infant mortality, ind. dep’t health, https://www.in.gov/isdh/27470.htm [https://perma. cc/5prw-y4gk] (last visited july 20, 2020). 54. cdc, supra note 39. 55. id. a preterm birth is one that occurs prior to the thirty-seventh week of gestation, or three weeks early. the earlier a baby is born, the more likely it is to experience complications. mayo clinic staff, premature birth, mayo clinic (dec. 21, 2017), https://www.mayoclinic.org/ diseases-conditions/premature-birth/symptoms-causes/syc-20376730 [https://perma.cc/xv6sb4uk]. low birth weight is defined as a baby born weighing less than five pounds and eight ounces. low birth weight, u. rochester med. ctr., https://www.urmc.rochester.edu/ encyclopedia/content.aspx?contenttypeid=90&contentid=p02382 [https://perma.cc/2quw-9cuy]. 56. ind. u. sch. med., supra note 2. 57. pregnancy complications, ctr. for disease control & prevention (oct. 23, 2018), h t t p s : / / w w w . c d c . g o v / r e p r o d u c t iv e h e a l t h / m a te rn a lin fan th ea lth /pregn an cycomplications.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2freproductivehealth %2fmaternalinfanthealth%2fpregcomplications.htm [https://perma.cc/7ntx-ee3f]; maternal, infant, and child health, off. disease prevention & health promotion, https://www. healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health#top [https://perma.cc/lpb7-ka7m] (last visited mar. 28, 2021). 58. mayo clinic staff, sudden infant death syndrome (sids), mayo clinic (may 20, 2020), https://www.mayoclinic.org/diseases-conditions/sudden-infant-death-syndrome/symptomscauses/syc-20352800 [https://perma.cc/n3k6-elan]. 59. am. health rankings, supra note 44. 378 indiana health law review [vol. 18:371 sids (14.4 percent), accidents or assaults (4.5 percent), and what is referred to as “other” (12.7 percent).60 though many of the leading causes of infant death, such as sids, may not necessarily be preventable, there are ways to reduce the risks. one of the best ways to reduce the risk of adverse infant health is to receive appropriate prenatal care.61 once the infant is born, infant health care and education for the mother on how to best care for the baby – particularly on subjects such as safe sleep practices and feeding – can help to reduce an infant’s risk of death in their first year of life.62 c. adverse childhood experiences and toxic stress the term adverse childhood experiences (“aces”) encompasses a multitude of traumas and toxic stress experienced prior to a person’s eighteenth birthday.63 these traumas can include physical abuse, witnessing the abuse of a parent, food or shelter insecurity, substance abuse by a parent, or parental incarceration.64 approximately sixty percent of adults in america have experienced one or more adverse experiences in childhood.65 on average, 20.5 percent of american children aged zero to seventeen experienced two or more adverse events in 2019.66 the seminal study on aces was conducted in 1997 by kaiser permanente health and the cdc.67 the study showed “a strong graded relationship between the breadth of exposure to abuse or household dysfunction during childhood and multiple risk factors for several of the leading causes of death in adults.”68 60. ind. univ. sch. med., supra note 2. there is no definitive reason for sids, but there are some risk factors including preterm birth and low birth weight. sids fact sheet, ill. dep’t health, http://www.idph.state.il.us/sids/sids_factsheet.htm [https://perma.cc/4zbj-m83s] (last visited mar. 28, 2021). 61. are there ways to reduce the risk of infant mortality?, nat’l inst. child health & hum. dev., https://www.nichd.nih.gov/health/topics/infant-mortality/topicinfo/reduce-risk [https:// perma.cc/s7gw-je75] (last visited mar. 28, 2021). 62. id. 63. tracy flanagan et al., feasibility and acceptability of screening for adverse childhood experiences in prenatal care, 27 j. women’s health 903, 903 (2018). 64. laura starecheski, take the ace quiz – and learn what it does and doesn't mean, npr (mar. 2, 2015), https://www.npr.org/sections/health-shots/2015/03/02/387007941/take-theace-quiz-and-learn-what-it-does-and-doesnt-mean [https://perma.cc/8pba-qvg9]. 65. flanagan et al., supra note 63. 66. adverse childhood experiences, am. health rankings (2019), https://www. americashealthrankings.org/explore/health-of-women-and-children/measure/aces/state/in [https://perma.cc/zz25-2d2q]. 67. about the cdc-kaiser ace study, ctr. for disease control & prevention, https://www.cdc.gov/violenceprevention/childabuseandneglect/acestudy/about.html [https://perma.cc/b32d-767x] (last updated apr. 13, 2020). 68. vincent j. felitti et al., relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: the adverse childhood experiences (ace) study, 14 am. j. prev. med. 245, 245 (1998). 2021] minding baby 379 though the study was conducted in the late 1990s, the results did not gain significant attention until well into the 2000s when the current surgeon general of california, dr. nadine burke harris, took notice in her practice of the effects of trauma on her pediatric patients.69 dr. harris began research of her own and is now one of the leading experts on aces and ace policy.70 since then, aces have become a centerpiece of early childhood research.71 however, research on adult outcomes, and more specifically the effects of trauma on expecting mothers, is still limited. one connection that has been fairly well-established in the literature is the connection between maternal depression and trauma experienced by the mother in childhood.72 a number of studies have found a connection between the number of aces experienced by a mother and her risk of developing some form of perinatal depression.73 a dose-response relationship was reported between the number of aces and the likelihood of developing either prenatal or postpartum depression; the higher a mother’s ace score, the more likely she was to develop depression at some point.74 stress is a common part of life for all humans, but particular types of stress can be damaging to developing children. there are three generally recognized types of stress: positive stress, tolerable stress, and toxic stress.75 positive stress refers to the normal, healthy stress that all people experience during childhood and adolescence.76 examples of positive stress for a child could include the first time at school or daycare away from a parent, or routine doctor’s visits and 69. see generally nadine burke harris, the deepest well: healing the long-term effects of childhood adversity 1 (2018). 70. id. 71. see sukhdip k. purewal et al., screening for adverse childhood experiences (aces) in an integrated pediatric care model, 36 zero to three j. 10, 10-17 (2016); yael cannon, a mental health checkup for children at the doctor’s office: lessons from the medical-legal partnership movement to fulfill medicaid’s promise, 17 yale j. health pol’y. l. ethics 253 (2017); jack p. shonkoff et al., the lifelong effects of early childhood adversity and toxic stress, 129 pediatrics e232 (2012). 72. see esther k. chung et al., depressive symptoms in disadvantaged women receiving prenatal care: the influence of adverse and positive childhood experiences, 8 ambulatory pediatrics 109 (2008); joshua p. mersky & colleen e. janczewski, adverse childhood experiences and postpartum depression in home visiting programs: prevalence, association, and mediating mechanisms, 22 maternal & child health j. 1051 (2018). 73. see generally chung et al., supra note 72; mersky & janczewski, supra note 72. 74. chung et al., supra note 72. a dose-response, which involves a relationship between an exposure and the risk of an outcome, is a relationship where increasing levels of an exposure are associated with either an increasing or a decreasing risk of an outcome. sydney pettygrove, doseresponse relationship, britannica, https://www.britannica.com/science/dose-responserelationship [https://perma.cc/w6l2-94uj] (last visited mar. 29, 2021). 75. toxic stress, ctr. on developing child harv. u., https://developingchild. harvard. edu/science/key-concepts/toxic-stress/ [https://perma.cc/yxg7-g5th] (last visited mar. 20, 2020). 76. id. 380 indiana health law review [vol. 18:371 immunizations.77 the “middle level” of stress is referred to as tolerable stress. tolerable stress “activates the body’s alert systems to a greater degree as a result of more severe, longer-lasting difficulties.”78 examples of tolerable stress would be the loss of a loved one or a serious injury or illness.79 while both of these forms of stress can have serious implications, supportive adult relationships that enhance a child’s ability to cope will generally allow a child to recover from them.80 the strongest and most damaging form of stress is called toxic stress. stress becomes toxic after prolonged exposure to extreme trauma experiences.81 living under this level of stress for long periods of time creates a buildup of cortisol – the hormone that is released during times of stress or anxiety.82 large amounts of cortisol in the body can result in a number of adverse effects including developmental delay and cognitive development.83 examples of toxic stress include prolonged physical, sexual, or emotional abuse, prolonged periods of poverty or food instability, exposure to substance abuse, or the death or imprisonment of a caregiver.84 once stress becomes toxic, the cumulative effect on a child can result in negative health impacts for the remainder of their life.85 a method for screening for aces has been developed and proved to be effective.86 the screening consists of ten yes-or-no survey questions regarding three areas of childhood trauma: abuse, neglect, and household dysfunction.87 the aces assessment has been shown to take less than ten minutes.88 the screening has been tested in clinical settings and shown to be an accurate predictor of health outcomes.89 iii. literature review a. connection between maternal depression and infant health outcomes maternal depression, both during pregnancy and after, has shown to have 77. id. 78. id. 79. id. 80. what is toxic stress, fla. st. u., https://med.fsu.edu/childstress/whatis [https://perma. cc/q3nh-bpxa] (last visited mar. 20, 2020). 81. id. 82. harris, supra note 69, at 21. 83. see toxic stress, supra note 75. 84. id. 85. id. 86. felitti et al., supra note 68, at 246-49. 87. meryl schulman & alexandra maul, screening for adverse childhood experiences and trauma, ctr. for health care strategies (feb. 2019), https://www.chcs.org/media/ta-toolscreening-for-aces-and-trauma_020619.pdf [ https://perma.cc/869f-94me]. 88. id. 89. see id. 2021] minding baby 381 significant health effects on the infant both in utero and after birth.90 depression creates a chemical change in the mother that directly affects hormone production and can have dangerous ramifications for the infant.91 these changes in hormones can cause preterm birth, low birth weight, and cognitive and developmental delay in babies.92 preterm birth and low birth weight are also two of the biggest contributors to infant death.93 a study conducted in sweden between 2007 and 2012 examined more than 350,000 births.94 researchers tested both parents for depression, followed the pregnancy, and then recorded if the infant was born either very preterm (born between twenty-two and thirty-one weeks) or moderately preterm (born between thirty-one and thirty-six weeks).95 the study showed that mothers who had new or recurrent depression had between a thirty percent and forty percent increased risk for moderately preterm birth.96 one of the most important aspects of infant development is called “serve and return.”97 serve and return refers to the “give and take” exchange between infants and adults where infants react to adult interaction and vice versa.98 an example of a serve and return interaction would be an adult making a silly face at a baby, which in turn results in the baby responding by giggling.99 maternal depression has been shown to affect a mother’s ability to perform the serve and return pattern that is essential to an infant’s brain development.100 babies who do not receive this stimulation at a young age can experience developmental and cognitive delays.101 babies who are consistently deprived of the necessary serve and return exchange can suffer from toxic stress that can ultimately lead to adverse health outcomes and continue the cycle for future generations.102 b. generational effects of maternal depression and toxic stress maternal mental health and maternal trauma are public health issues. trauma and mental health disorders experienced by mothers can directly affect the health 90. wile, supra note 10. 91. id. 92. id. 93. ind. u. sch. med., supra note 2. 94. depression of either parent during pregnancy linked to premature birth, sciencedaily (jan. 20, 2016), www.sciencedaily.com/releases/2016/01/160120091754.htm [https://perma.cc/l9wa-hqf3]. 95. id. 96. id. 97. wile, supra note 10. 98. id. 99. id. 100. maternal depression in rhode island: two generations at risk, r.i. kids count (jan. 2018), http://rikidscount.org/portals/0/uploads/documents/issue%20briefs/3.18%20maternal% 20depression%20update.pdf [https://perma.cc/mr7p-weey]. 101. id. 102. wile, supra note 10. 382 indiana health law review [vol. 18:371 of their infant and may even have a generational effect. epigenetics is the idea that trauma can leave a “chemical mark” on a person’s genes and be passed down to future generations.103 this leads to a seemingly endless cycle of trauma and associated mental health disorders. several studies have shown direct correlations between high rates of childhood trauma in mothers and poor health outcomes in infants.104 in addition, studies have shown that mothers with multiple aces are more likely to develop depression.105 trauma changes the chemistry in the brain in a way that is inheritable.106 even if the child themselves never experience trauma, they may still experience poor health outcomes that are associated with trauma, simply because their mother had a high prevalence of aces.107 this can also be true for maternal depression. recent studies have shown that there is now “converging evidence supporting the idea that offspring are affected by parental trauma exposures occurring before their birth, and possibly even prior to their conception.”108 trauma experienced by the mother can be passed genetically to her infant and the effects of such trauma can be felt for multiple generations. studies done regarding epigenetics and health risk behaviors during pregnancy have shown that the behaviors of a mother will not only affect the child but can affect up to three additional generations.109 studies have shown that early traumatic experiences evoke a cascade of system-wide changes that persist into adulthood and then those genetic changes can be passed along to future generations.110 c. adverse childhood experiences and maternal and fetal health exposure to trauma in childhood has been shown to affect mothers and babies both during pregnancy and birth, as well as after the birth of the child.111 though 103. benedict carey, can we really inherit trauma?, n.y. times (dec. 10, 2018), https://www.nytimes.com/2018/12/10/health/mind-epigenetics-genes.html [https://perma.cc/5vwpkxxz]. 104. see christina g. mcdonnell & kristin valentino, intergenerational effects of childhood trauma: evaluating pathways among maternal aces, perinatal depressive symptoms, and infant outcomes, 21 child maltreatment 317, 317-26 (2016); see also nicole racine et al., maternal adverse childhood experiences and infant development, 141 pediatrics art. e20172495 (2018). 105. see karen a. ertel et al., maternal depression in the united states: nationally representative rates and risks, 20 j. women’s health 1609 (2011). 106. rachel yehuda & amy lehrner, intergenerational transmission of trauma effects: putative role of epigenetic mechanisms, 17 world psychiatry 243, 243-57 (2018). 107. id. 108. id. 109. carey, supra note 103. 110. nicole r. nugent et al., topical review: the emerging field of epigenetics: informing models of pediatric trauma and physical health, 41 j. pediatric psychol. 55, 55-64 (2016). 111. see megan v. smith et al., early childhood adversity and pregnancy outcomes, 20 maternal child health j. 790 (2016). 2021] minding baby 383 this is a relatively new field of research, several studies have found that “a doseresponse relationship exists between the number of reported adverse childhood events and risk of having an operative delivery or infant’s admission to the neonatal intensive care unit.”112 adverse childhood experiences can also lead to difficulties in pregnancy including maternal depression and substance abuse.113 screening for trauma can inform care during pregnancy and potentially reduce the adverse health outcomes that have been shown the be associated with higher rates of trauma in childhood. in indiana, this is particularly of importance because indiana’s maternal and infant mortality rate is higher than the national rate of such.114 children of mothers who have been exposed to aces are at increased risk of a multitude of poor health and developmental outcomes.115 these outcomes can include delayed achievement of developmental milestones and increased likelihood of parent-child relationship difficulties in infancy.116 numerous studies have shown that there is a significant connection between a high number of aces experienced by the mother and her development of maternal depression.117 a study conducted with low-income pregnant women of all ages and races showed that the prevalence of aces, particularly in lowincome women, was significantly higher than the original aces study estimated.118 furthermore, the study found that there was a very high association between aces and postpartum and antepartum depression.119 results showed that exposure to aces increases the risk of adverse adult experiences, which also increases the risk of poor mental health.120 iv. policy review a. recommendations from u.s. health care organizations several u.s. health care organizations have published recommendations on screening mothers for perinatal depression.121 the american college of 112. id. at 791. 113. racine et al., supra note 104. 114. indiana summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/in?editionyear=2019 [https://perma.cc/v8px-94bk]. 115. racine et al., supra note 104. 116. id. 117. see mersky & janczewski, supra note 72, at 1058; jasmine e. kim et al., the association between maternal adverse childhood experience and maternal depression: a longitudinal cohort study, 57 j. am. acad. child adolescent psychiatry s227 (2018); racine et al., supra note 104. 118. mersky & janczewski, supra note 72. 119. id. 120. id. 121. see comm. on obstetric practice, am. coll. of obstetrics & gynecologists, screening for perinatal depression, 132 obstetrics & gynecology e208 (2018); screening process 384 indiana health law review [vol. 18:371 obstetricians and gynecologists published a committee opinion in 2018 (the original opinion was published in 2015 but updated in 2018) recommending that all providers “complete a full assessment of mood and emotional well-being (including screening for postpartum depression and anxiety with a validated instrument) during the comprehensive postpartum visit for each patient.”122 similarly, the american academy of pediatrics (“aap”) recommends screening the mother for depression during an infant’s well-child visit.123 the aap argues that untreated maternal depression can “lead to impaired parent-child interaction, discontinuation of breastfeeding, child abuse and neglect, and family dysfunction.”124 other pediatric and maternal health organizations are in agreement on the importance of screening and treating maternal depression. the association of women’s health obstetric and neonatal nurses (“awhonn”) stated in a formal opinion that “all postpartum women should be screened for mood and anxiety disorders.”125 the awhonn also recommends “systematic screening in pregnancy and the postpartum period [to] help detect early symptoms of perinatal psychiatric distress.”126 b. current indiana policy in the 2019 session of the indiana general assembly, house bill 1007 was passed.127 the law established a perinatal navigator program called the ob navigator program.128 the program, which was slated to begin in january 2020, is in a pilot stage, with only twenty-two of indiana’s ninety-two counties participating at the outset.129 “the ob navigator program is a collaboration between the indiana state department of health (isdh), the indiana family and social services administration (fssa) and the indiana department of child services (dcs).”130 this initiative will create a network of wraparound services resources, am. acad. pediatrics, https://www.aap.org/en-us/advocacy-and-policy/aap-healthinitiatives/screening/pages/screening-recommendations.aspx [https://perma.cc/66y7-46hk] (last visited feb. 2, 2021); marian f. earls et al., incorporating recognition and management of perinatal depression into pediatric practice, 143 pediatrics art. 20183259 (2019); assoc. of women’s health, obstetric & neonatal nurses, mood and anxiety disorders in pregnant and postpartum women, 44 j. obstetric, gynecologic & neonatal nursing 687, 689 (2015); nat’l assoc. of pediatric nurse practitioners, napnap position statement on the pnp’s role in supporting infant and family well-being during the first year of life, 25 j. pediatric health care 9a (2011). 122. see comm. on obstetric practice, supra note 121. 123. see screening process resources, supra note 126. 124. id. 125. assoc. of women’s health, obstetric and neonatal nurses, supra note 121, at 687. 126. id. 127. ind. code § 16-35-11-3 (2019). 128. id. 129. my health baby: indiana’s ob navigator program, supra note 3. 130. id. 2021] minding baby 385 to support healthier outcomes for mothers and babies.131 the program will require health care providers who provide maternal care in indiana’s most at-risk counties to administer a “validated and evidence-based verbal screening tool to assess substance abuse” in pregnant patients.132 if, after using the screening tool, a health care provider identifies a pregnant woman who has a substance use disorder and is not currently receiving treatment, the health care provider must: (1) provide treatment to the patient; or (2) refer the patient to treatment.133 although the act only specifies that maternal health providers screen for and treat substance abuse, the intent is that the program will go far beyond just treating moms with substance use disorder. the ob navigator program will include a sliding scale of care for women who are pregnant and on medicaid.134 the levels of care will include, from least intervention to most intervention, the following initiatives: healthy families indiana, community health partners, the paramedic program, and the nurse-family partnership.135 dcs is already providing home visitation services via its healthy families indiana program.136 this program operates in every county in the state and offers home visitation services for children and families. it is a “voluntary evidencebased home visitation program that is designed to promote healthy families and healthy children through a variety of services including child development, access to health care, and parent education.”137 at this level, mothers who have had previous uncomplicated pregnancies will be provided education and support, but no other interventions.138 the second tier of care in the ob navigator program will be the community health partners.139 this tier is for women who are not immediately flagged as high risk, but who perhaps have not had a pregnancy previously, or who need more support than other mothers. the third level of care will be the paramedic program.140 this level is designated for women who are at a higher risk of fetal or maternal health issues. women who have had previous issues with pregnancies, or who are already engaging in health-risk behaviors may be assigned to this level. at this level, the women will have access to their assigned paramedic who will be available to assist them with any potential health issues that arise, as well as continually check in with the women for routine health screenings during their pregnancy.141 the final level, and the level with the greatest amount of intervention, will be 131. id. 132. h.b. 1007, 121st gen. assemb., 1st reg. sess. (ind. 2019). 133. id. 134. my health baby: indiana’s ob navigator program, supra note 3. 135. id. 136. id. 137. id. 138. id. 139. id. 140. id. 141. id. 386 indiana health law review [vol. 18:371 the nurse-family partnership.142 women who are actively engaging in health-risk behaviors and are consequently at the highest risk will be assigned to this level. women who are weening off of illicit substances, such as opioids, would be assigned to this level. nurses are assigned to the mothers and are available for the women for the duration of their pregnancy to assist with health issues and monitor the mother during treatment.143 indiana’s standards for prenatal care currently only address the requirements for hospitals, birthing centers, neonatal care, and physicians.144 the standards do not address maternal mental health, or the requirement of any screenings during any point in the pregnancy or postpartum.145 c. maternal mental health and trauma screening policy in other states in the united states, thirty-five states plus the district of columbia have implemented policies that require or recommend maternal mental health screenings both during and after the pregnancy.146 some of the states have continuing education requirements for providers, and some have created an outline for how the providers will be reimbursed for the screening services.147 this portion of the note will review policies in states that are geographically or politically similar to indiana, or states that are also ranked in the bottom ten nationally for infant mortality as well as discuss some of the infant and maternal health statistics for the states under review. 1. georgia georgia is ranked as one of the worst states for infant mortality. they currently are ranked as forty-five out of fifty with 7.6 deaths per 1,000 live births.148 as a response, georgia added screening for maternal depression as a requirement during well-child visits.149 georgia’s provider manual, detailing the state’s early and periodic screening, diagnostic and treatment services (“epsdt”), requires that all medicaid mothers be screened for depression during 142. id. 143. id. 144. see generally 410 ind. admin. code art. 39 (2020) (addressing indiana maternal care standards). 145. see generally id. 146. medicaid policies for maternal depression screening (mds) during well-child visits, by state, nat’l acad. for st. health pol’y (mar. 1, 2018), https://healthychild.nashp.org/wpcontent/uploads/2018/04/nashp-mds-table-4.24.18.pdf [https://perma.cc/w4ab-em85]. 147. id. 148. georgia summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/ga?editionyear=2019 [https://perma.cc/nu9p-7q45]. 149. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 2021] minding baby 387 their child’s one-, two-, four-, and six-month visits.150 the reimbursement rate for screenings is $3.95 per screening and is included as part of georgia’s epsdt.151 if a mother screens positive for depression she is referred to the georgia crisis and access line (“gcal”).152 “gcal, a statewide toll free crisis hotline, provides access to resources and services to individuals in need of crisis management for mental health, addictive disease, and crisis services.”153 this service is available to anyone who needs it twenty-four hours a day and seven days a week by phone or website.154 2. mississippi mississippi has the highest infant mortality rate of all fifty states at 9.1 deaths per 1,000 live births.155 the state implemented required screenings for maternal depression during the first six months of an infant’s life.156 screenings are administered once during the infant’s one-, two-, four-, and six-month visits.157 the screening is reimbursable by fee for service at the rate of $3.65 per screening.158 caregivers other than the child’s mother are not eligible for screenings.159 3. michigan michigan added maternal depression screenings as a required portion of epsdt in 2017 and implemented the practice in 2018.160 mothers are to be 150. div. of medicaid, ga. dep’t of cmty. health, part iii: policies and procedures for early and periodic screening, diagnostic and treatment (epsdt) services – health check program (cos 600) (2021), at ix-15, https://www.mmis.georgia.gov/portal/portals/ 0/staticcontent/public/all/handbooks/epsdt%20services%20health%20check%20program%20m anual%2020201216205300.pdf [https://perma.cc/7hks-uqjy]. 151. id. at x-9. 152. id. 153. id. 154. id. 155. mississippi summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/ms?editionyear=2019 [https://perma.cc/h5gt-vv25]. 156. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 157. epsdt periodic examination schedule, miss. division medicaid, https://medicaid.ms. gov/wp-conten t/uploads/2016/07 /epsdt-periodicity-examination-schedule.pdf [https://perma.cc/ac6m-22en] (last visited mar. 29, 2021). 158. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 159. id. 160. see mich. dep’t of health & human servs., bulletin no. msa 17-34, updates to the early and periodic screening, diagnosis and treatment chapter of the medicaid 388 indiana health law review [vol. 18:371 screened per the aap’s guidelines which recommend screening at the infant’s one-, two-, four-, and six-month well-visits.161 michigan has included maternal depression screenings as part of its infant mortality reduction plan.162 the infant mortality rate in michigan has been slowly declining from 2016, when it was at 7.0 deaths per 1,000 live births, to 2019, when it was 6.5 deaths per 1,000 live births.163 4. texas texas passed legislation that not only addresses the importance of maternal mental health screening but also lays out a plan for how providers will be reimbursed. the texas statute states that “[t]he covered services under the child health plan must include a maternal depression screening for an enrollee's mother, regardless of whether the mother is also an enrollee, that is performed during a covered well-child or other office visit for the enrollee that occurs before the enrollee's first birthday.”164 this progressive stance on maternal mental health screening allows for greater access to care, something that is particularly important in texas where 25.6 percent of women in the state are uninsured.165 since these changes have been made, infant deaths in texas are trending down. the texas infant mortality rate for 2019 was 5.7 deaths per 1,000 births.166 this is lower than the national average and lower than the previous three years in texas.167 these numbers show that screening for maternal depression during well-child visits successfully reduces infant deaths. 5. illinois illinois has an infant mortality rate of 6.2 deaths per 1,000 births, which is higher than the national average.168 illinois has a maternal mortality rate of 21.4 provider manual and 2017 american academy of pediatrics periodicity schedule 1 (2017), https:/ /www.michigan.gov/documents/mdhhs/msa_17-34_607322_7.pdf [https://perma.cc/vj3g-vdms]. 161. see id. at 2. 162. see medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146; mich. dep’t of health & human servs., mother infant health & equity improvement plan 1 (2020), https://www.michigan.gov/documents/ infantmortality/final_miheip_665052_7.pdf [https://perma.cc/nw49-w8cn]. 163. mich. dep’t of health & human servs., supra note 160. 164. tex. health & safety code § 62.1511 (2019). 165. texas summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/tx?editionyear=2019 [https://perma.cc/v88q-m7hm]. 166. id. 167. id. 168. illinois summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/il?edition2021] minding baby 389 deaths per 100,000 live births.169 the rate of postpartum depression is 9.3 percent.170 in the 2019 session of the illinois general assembly, a bill recognizing the importance of maternal mental health was passed.171 a further bill was passed to require educational materials to be distributed at all birthing hospitals statewide.172 the statute states in part that [t]he department shall develop educational materials for health care professionals and patients about maternal mental health conditions. a birthing hospital shall, on or before january 1, 2021, distribute these materials to employees regularly assigned to work with pregnant or postpartum women and incorporate these materials in any employee training that is related to patient care of pregnant or postpartum women.173 the statute goes on to describe what the materials should include, such as materials for physicians and hospital staff on how to recognize maternal depression, as well as materials for new mothers and fathers on signs and symptoms of maternal depression.174 this is not the first time that illinois sought to address maternal depression. in 2008, it was one of the first states to pass legislation regarding maternal mental health and screening practices.175 the perinatal mental health disorders prevention and treatment act compels health care professionals to meet certain requirements, including both prenatal care as well as postnatal care.176 for prenatal care, providers must present educational material on maternal mental health disorders to all patients.177 in addition, [l]icensed health care professionals providing prenatal care at a prenatal visit shall invite each pregnant patient to complete a questionnaire and shall review the completed questionnaire . . . . assessment for perinatal mental health disorders must be repeated when . . . a reasonable possibility exists that the woman suffers from perinatal mental health disorders.178 the statute also covers postnatal care, requiring that all birthing hospitals year=2019 [https://perma.cc/9x8s-fpfp]. 169. id. 170. id. 171. 405 ill. comp. stat. 120/5 (2020). 172. id. 173. id. 174. id. 175. screening and treatment for perinatal mental health disorders, ill. dep’t hum. serv., https://www.dhs.state.il.us/page.aspx?item=35251 [https://perma.cc/3lzc-ejvm] (last visited mar. 29, 2021). 176. 405 ill. comp. stat. ann. 95/15 (2019). 177. id. 178. id. 390 indiana health law review [vol. 18:371 distribute educational materials to the mothers (and if possible, fathers) prior to discharge and offer screening services to all mothers receiving postnatal care.179 finally, the statute covers screenings at well-baby visits.180 the statute provides that “[l]icensed health care professionals providing pediatric care to an infant shall invite the infant's mother to complete a questionnaire at any well-baby check-up at which the mother is present prior to the infant's first birthday.”181 illinois reimburses providers on a fee-for-service basis. the reimbursement rate for a screening is $14.60.182 the state of illinois does not allow for other caregivers besides the mother to be screened.183 if a mother screens positive for maternal depression, providers can offer information on resources and referral services.184 6. ohio ohio recommends screenings during well-child visits as medically necessary.185 services are available for caregivers of children on medicaid who are reimbursed at a rate of $3.43 per screening.186 if a mother screens positive for depression, they are offered enhanced care, including wraparound.187 ohio is one of the bottom ten states for infant mortality. with a death rate of 7.3 infant fatalities per 1,000 live births, ohio is ranked at forty-first.188 since 2016, ohio has put a heavy focus on improving its infant health outcomes. the ohio provision of enhanced maternal care services was created by their medicaid office in june 2016 and called for improvement on support and care for all ohio medicaid mothers and babies.189 179. id. 180. id. 181. id. 182. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 183. id. 184. id. 185. id. 186. ohio rev. code § 5167.17 (2021); see generally ohio dep’t of medicaid, guidance for managed care plans: provision of enhanced maternal care services 2 (2016), https://medicaid.ohio.gov/portals/0/providers/providertypes/managed%20care/provision-forenhanced-maternal-care.pdf [https://perma.cc/zrj3-9s6g]. 187. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146; see § 5167.17. 188. ohio summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/oh?editionyear=2019 [https://perma.cc/mt6k-zceu]. 189. see ohio dep’t of medicaid, supra note 186. 2021] minding baby 391 7. tennessee in the past three years, tennessee has seen an increase in infant mortality rates.190 in 2019, the infant mortality rate in tennessee matched that of indiana at 7.4 deaths per 1,000 live births.191 a low estimate is that 15.4 percent of mothers in tennessee are diagnosed with postpartum depression.192 in response, tennessee added mental health and maternal depression as a key strategy to their tenncare quality improvement plan.193 tennessee recommends that all mothers be screened for maternal depression at well-child visits.194 other caregivers are allowed to be screened as well, as long as they are a tenncare member.195 reimbursement rates are not made clear for screenings.196 providers are able to offer referral follow-up and guidance to mothers who screen positive for depression.197 8. west virginia the infant mortality rate in west virginia is slightly lower than in indiana at 7.2 deaths per 1,000 live births.198 policy in west virginia recommends that mothers are screened for depression at well-child visits.199 in 2012, west virginia added maternal depression screenings to its home visitation program.200 the policy allows for mothers to be screened up to four times within the first 120 days 190. tennessee summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/tn?editionyear=2019 [https://perma.cc/q3ej-85af]. 191. id. 192. the importance of maternal depression screenings, tenn. just. ctr., https://www. tnjustice.org/importance-maternal-depression-screenings/https://www.tnjustice.org/importancematernal-depression-screenings/ [https://perma.cc/tnl2-yrwy] (last visited mar. 28, 2021). 193. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146; see generally div. of tenncare, 2019 update to the quality assessment and performance improvement strategy 8 (2019), https://www.tn.gov/ content/dam/tn/tenncare/documents2/2019updateofqualityimprovementstrategy.pdf [https://perma.cc/r4nf-8btr]. 194. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 195. id. 196. id. 197. id. 198. west virginia summary 2019, am. health rankings (2019), https://www. am er icash ea lth ran kin gs .o rg / explore/health-of -w omen -an d-ch ild ren /m easu re / imr_mch/state/wv?edition-year=2019 [https://perma.cc/6bvb-w8xt]. 199. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 200. benchmarks, w. va. dep’t health & hum. res. (dec. 5, 2012), https://www.wvdhhr. org/wvhomevisitation/pdf/wvhvp_benchmarks_2013.pdf [https://perma.cc/24xc-xauu]. 392 indiana health law review [vol. 18:371 of their infant’s life.201 the reimbursement rate is $2.78 per screening and providers are able to offer follow-up and referral services.202 9. alabama in 2017, alabama medicaid added maternal depression screenings as a reimbursable test during well-child visits.203 the screenings are reimbursable through medicaid code 96161, which allows for the “[a]dministration of caregiver-focused health risk assessment instrument.”204 alabama does not give specific guidelines on when or how many times the screenings can be provided during well-child visits.205 postpartum depression in alabama has been on the rise jumping from 16.3 percent in 2018 to 19.9 percent in 2019.206 infant mortality has remained steady in the state moving up only slightly from 8.5 deaths per 1,000 live births in 2018 to 8.7 deaths per 1,000 live births in 2019.207 though still higher than the national average of 20 percent, alabama has seen a decrease in the percentage of children with two or more aces, dropping from 27.7 percent in 2018 to 26.3 percent in 2019.208 10. kentucky kentucky recommends maternal depression screening “as is medically necessary.”209 the reimbursement rate is $3.38, and there are no limits on how many screenings may be performed.210 caregivers other than the mother are also eligible for screening at the same reimbursement rate.211 in the case that a mother screens positive for depression managed care organizations “offer toolkits to 201. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 202. id. 203. id. 204. aap div. of health care fin., update on use of, payment for new health risk assessment codes, aap news (may 24, 2017), https://www.aappublications.org/news/2017/ 05/24/coding052317 [https://perma.cc/nsn9-9mrz]. 205. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 206. alabama summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/al?editionyear=2019 [https://perma.cc/y22v-chmk]. 207. id. 208. id. 209. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 210. id. 211. id. 2021] minding baby 393 providers with guidance for referral and follow up services.”212 kentucky ranks as thirty-six out of fifty states for infant mortality with 6.7 deaths per 1,000 live births.213 for aces, kentucky ranks in the bottom ten states with 25.8 percent of children screening positive for two or more aces.214 11. delaware delaware added a maternal mental health policy to its public health code in 2016, recommending that mothers be screened for depression during well-child visits.215 the legislation calls for the delaware division of public health to create educational materials regarding maternal depression.216 the statute further states that health care providers shall provide educational materials to mothers who present depressive symptoms.217 finally, the policy asserts that “health care provides shall begin evaluations and take action when they recognize symptoms of maternal depression in a woman or family.”218 health care providers are reimbursed through medicaid at a rate of $3.95 per screening.219 since 2017, infant mortality has been on the rise in delaware.220 the rate rose from 6.6 deaths per 1,000 in 2017 to 8.5 deaths per 1,000 in 2019.221 maternal mortality in delaware is lower than the national average at 16.9 deaths per 100,000 births.222 postpartum depression declined in the last year from 13.9 percent to 11.7 percent.223 12. district of columbia in 2018, the district of columbia (“dc”) created a maternal mental health task force.224 the task force was charged with identifying vulnerable 212. id. 213. kentucky summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/ky?editionyear=2019 [https://perma.cc/a7a6-bxfs]. 214. id. 215. del. code tit. 16, § 801d (2021); medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 216. tit. 16, § 801d. 217. id. 218. id. 219. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 220. delaware summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/de?editionyear=2019 [https://perma.cc/jy5m-vatl]. 221. id. 222. id. 223. id. 224. d.c. code § 7-1233.02 (2021). 394 indiana health law review [vol. 18:371 populations and risk factors, identifying barriers to screening and models for private and public funding for maternal mental health screening and treatment.225 infant mortality in dc is significantly higher than the national average at 8 deaths per 1,000 live births.226 the maternal mortality rate in dc is also much higher than the national average at 35.6 deaths per 100,000 live births.227 the maternal mental health task force will be able to collect data on maternal mental health and use that to create legislation to make screening and services more accessible. d. federal policy the bringing postpartum depression out of the shadows act was passed in 2016 and was the first time that congress recognized the importance of maternal mental health treatment.228 the act allows for the department of health and human services (“hhs”) to provide grant funding to states for the purpose of establishing maternal depression screening programs or educational programs.229 the law provides that states that propose programs to enhance access to screening will be given priority.230 the act also allows for funding to be used for educating and training physicians on maternal mental health disorders.231 further, the centers for medicaid and medicare services authorized state agencies to provide maternal depression screenings as a service for children at well-child visits reimbursable under epsdt, to which all children covered on medicaid are entitled.232 in 2018, minnesota was awarded a block grant through this act, which allocated funds to provide screening and home-based services for perinatal mood and anxiety disorders.233 the grant allows for services to extend up to the first year of the child’s life.234 the grant money comes from hhs and can be used for “establishing new screening or treatment programs, or [to] expand or maintain existing screening or treatment programs.”235 the commissioner is responsible for determining who is eligible for use of the money and is mandated by the statute 225. id. 226. district of columbia summary 2019, am. health rankings (2019), https://www. am er icash ea lth ran kin gs .o rg / exp lore /h ea lth-of-women-and-ch ild ren /m easu re / imr_mch/state/dc?edition-year=2019 [https://perma.cc/5kxc-zhry]. 227. id. 228. caroline bologna, congress passes groundbreaking postpartum depression legislation, huffpost (dec. 7, 2016), https://www.huffpost.com/entry/congress-passes-groundbreakingpostpartum-depression-legislation_n_584053a6e4b09e21702d2a43 [https://perma.cc/2945-847k]. 229. 42 u.s.c. § 247b-13a (2020). 230. id. 231. id. 232. the importance of maternal depression screenings, supra note 192. 233. see minn. stat. § 145.908 (2021). 234. id. 235. id. 2021] minding baby 395 to prioritize screening and assessment of maternal mental health.236 v. recommendations for indiana policy though indiana is taking steps towards combating the high infant mortality rate, very little is being done regarding maternal mental health. as a state, indiana needs to recognize that maternal mental health and trauma play a significant role in the health of both mother and baby. policy needs to be enacted that will address the significance of maternal depression in the fight against infant and maternal mortality and will provide services for screening and treatment of maternal mental health. indiana should model its code after surrounding states that have adopted mandatory or recommended screening protocol. all mothers enrolled in medicaid or the healthy indiana plan (also known as hip, indiana’s medicaid expansion) should be screened for postpartum depression. policy should include a plan for reimbursement for the screening. like the texas statute, indiana should allow for mothers who are not covered under medicaid or hip, but whose babies are, to still be covered for purposes of screening up to the infant’s first birthday. once mothers have been screened, if diagnosed with maternal depression, services should be provided to treat the symptoms and offer support. services offered by the ob navigator program should be utilized as means of support for mothers struggling with depression. there are several services that already work in indiana that could potentially be leveraged for wraparound services.237 many of these organizations are already working with the ob navigator program and therefore would be easy to incorporate into mental health wraparound services. vi. conclusion current indiana policy surrounding maternal health addresses many important aspects of physical health, but largely disregards the importance of mental health. unlike many surrounding and similarly situated states, indiana does not require, recommend, or even allow for reimbursement for maternal depression screenings during well-child visits. this ultimately is causing significant costs to the state both socially and financially. there is a significant financial cost to ignoring maternal mental health. maternal mental health affects more than just the mother. for each infant born preterm, with birth defects, or birth complications, an estimated $93,800 is spent on health care for the child’s first year of life with most of that cost being borne 236. id. 237. some of these services include evidence practices that are endorsed by the indiana state department of health such as healthy families indiana and the nurse-family partnership. both organizations are home-visit based and serve elkhart, grant, lake, laporte, st. joseph, scott, delaware, madison, and marion through funding from the maternal, infant, & early childhood home visiting program. see maternal, infant, & early childhood home visiting (miechv) program, ind. dep’t health, https://www.in.gov/isdh/25565.htm [https://perma.cc/h4vb-8r8b] (last visited mar. 29, 2021). 396 indiana health law review [vol. 18:371 by medicaid.238 life-long adverse outcomes are possible for the infant. the ultimate cost of ignoring maternal mental health is too high. by shedding light on the reality of maternal depression and the effect of trauma on maternal health, indiana can become a national leader in maternal and infant health, and ultimately lower the infant and maternal mortality rate. nearby states, as well as states that (like indiana) are ranked in the bottom ten for infant mortality rates, have all taken action to combat maternal depression. if indiana is serious about lowering the infant mortality rate in this state it is time to follow the lead of other states, as well as the aap’s screening recommendations, which encourage screening medicaid mothers for maternal depression. 238. how much does infant mortality cost the nation, nat’l healthy start ass’n (2015), http://www.nationalhealthystart.org/healthy_start_initiative/how_much_does_infant_mortality_ cost#:~:text=those%20babies%20that%20survive%20the,smallest%20survivors%20will%20av erage%20%24273%2c900 [https://perma.cc/jn78-wutx]. microsoft word final for lulu vol. 14 issue 1 final a. the issue: increasing pharmaceutical prices b. why prescription affordability is important c. “phrma’s” contributions to the pricing problem d. general outline a. the legislation 1. hatch-waxman act 2. patient protection and affordable care act (“aca”) (“obamacare”) b. the judiciary (ftc v. actavis) a. introduction b. patent and antitrust laws c. generic pharmaceutical company issues d. increased marketing expenditures 1. detailing e. increasing costs of research & development f. increased medicare coverage a. off-label prescription drug use b. delaying generic entry potential abuses 1. pharmaceutical companies creating their own philanthropies then funding the 2. limiting the field of ideas to the ideas heavily funded by corporations http://doi.org/10.18060/3911.0033 potential benefits 1. increase innovation through nonprofit funding of research and development 2. economic repurposing of drug example: cystic fibrosis foundation collaboration with vertex pharmaceuticals a. federal tax re-evaluation for pharmaceutical representatives b. use of modified venture philanthropy 1. utilizing private nonprofit foundations with “program-support” grants 2. creating own private, operating, foundations a. the issue: increasing pharmaceutical prices here’s exactly how the united states spends $2.9 trillion on health care id. prescription drugs to lead trend of health care price increases, b. why prescription affordability is important c. “phrma’s” contributions to the pricing problem d. general outline health premium cost trends steady for 2015, but drug costs expected to rise see generally study shows about 48% of americans take at least one prescription drug see generally baby boomers just how many baby boomers are there? nearly 7 in 10 americans take prescription drugs, mayo clinic, olmsted medical center find the good news on fda and andas, pharmaceutical spending available at a. the legislation 1. hatch-waxman act the hatch-waxman act--25 years later: keeping the pharmaceutical scales balanced id id id 2. patient protection and affordable care act (“aca”)(“obamacare”) a. the pharmaceutical tax all new taxes for pharmaceutical and device manufacturers/importers/distributors id id supra see also annual fee imposed on prescription drug manufacturers and importers annual fee see generally new taxes for pharmaceutical and device manufacturers/importers/distributors id. id. id. b. national physician payment transparency program (“open payments”) c. congressional funding of research & development id. see also annual fee imposed on prescription drug manufacturers and importers supra see id. marketing and direct-to-consumer advertising (“dtca”) of pharmaceuticals, see generally open payments, id. id. see generally . id id see generally id . b. the judiciary (ftc v. actavis) ftc v. actavis actavis ftc v. actavis a. introduction big pharma’s favorite prescription: higher prices, see also pharmaceutical industry gets high off of fat profits, id. competition ahead? the legal landscape for reverse payment settlements after federal trade commission v. actavis, inc. id. id. see supra b. patent and antitrust laws see generally pharmaceutical industry pharmaceutical industry supra pharmaceutical industry supra pharmaceutical antitrust: delayed generic entry cases frequently asked questions on patents and exclusivity pharmaceutical corporations and medical research drug patent expirations and the “patent cliff” supra id. c. generic pharmaceutical company issues prescriptions for change: the hatch-waxman act and new legislation to increase the availability of generic drugs to consumers supra drug prices defy gravity, doubling or dozens of products, the industry id. be wary of stratospheric increases in generic drug prices, id. id. expose reveals why we no longer trust all generic drugs d. increased marketing expenditures detailing how a cabal keeps generics scarce supra see also, , supra there ain’t no such thing as a free lunch: a look at state disclosure laws and the effect on pharmaceutical company marketing see also big bad pharma: an ethical analysis of physician-directed and consumer-directed marketing tactics the impact of direct-to-consumer advertising big bad pharma: an ethical analysis of physician-directed and consumer-directed marketing tactics id. sorrell v. ims health see generally health care costs: a primer pharmaceutical detailing definition supra the pharma marketing glossary persuading the prescribers: pharmaceutical industry marketing and its influence on physicians and patients pharmaceutical detailing is not for everyone: side effects may include sub-optimal prescribing decisions, compromised patient health, and increased prescription drug spending supra regulating pharmaceutical marketing after sorrell v. ims health inc. https://doi.org/10.1080/01947648.2012.714328 sorrell v. ims health, id. id. new reps, new rap: the counter-detailers supra id. prescription drugs: academic detailing see id. supra id. see generally resistance to affordable care act continues nationwide supra sales innovation and metric report, 2014, e. increasing costs of research & development id. supra drug development r&d: new transaction structures id. supra supra supra supra medicines: costs in context supra f. increased medicare coverage id. more than 430 new medicines in development for top chronic diseases affecting older americans 2015 profile: biopharmaceutical research industry who funds biomedical research? phrma member companies invested $51.2 billion in r&d in 2014 id. pharmaceutical industry supra supra supra id. id. medicare’s rising cost – and the need for reform the facts on medicare and health spending and financing cms releases prescriber data for the first time how is medicare funded? supra supra id. id. fewer employers to offer retiree prescription drug plans: survey . id. id. id. supra a. off-label prescription drug use id. id. supra off-label use, prescription, and marketing of fda-approved drugs: an assessment of legislative and regulatory policy see also liability and off-label prescriptions id. off-label drug promotion and the first amendment off-label use promotion is protected free speech supra b. delaying generic entry id. off-label prescribing supra id. see id. id. medicines: cost in context new york attorney general examining whether turing restricted drug access id. economic basics: supply and demand supra . id. actavis typically id. see, e.g. supra pharmaceutical antitrust: delayed generic entry cases id. supra see generally abuse of the fda citizen petition process: ripe for antitrust challenge? id. ftc files amicus brief explaining that pharmaceutical “product hopping” can violate the antitrust laws id. antitrust scrutiny of pharmaceutical “product hopping ” id. venture capital philanthropy: the irs and treasury hold the no-cost key to the growth of self-sufficient nonprofits january 2002 id. supra see generally the emergence of ‘venture philanthropy’ raises new tax issues see also foundation grants supra venture philanthropy: the changing landscape ‘venture philanthropy’ is the new buzz in business who’s afraid of philanthrocapitalism?, the private foundation id. id. see see a. potential abuses see cystic fibrosis: charity and industry partner for profit supra see also the private foundation supra the private foundation supra loans see also see generally supra finding a cure: incentivizing partnerships between disease advocacy groups and academic and commercial researchers see the role of nonprofit institutes in pharmaceutical development advanced r&d by venture philanthropy 1. pharmaceutical companies creating their own philanthropies then funding them 2. limiting the field of ideas to the ideas heavily funded by corporations stop subsidizing big pharma id. see establishing a nonprofit organization walkthrough the private foundation supra id. supra id. supra id. b. potential benefits and increase innovation through nonprofit funding of research and development id. id. id. id id. see generally id. see generally supra see generally companies in north america see supra nonprofit drug companies http://doi.org/10.1377/hlthaff.24.6.1684 2. economic repurposing of drugs id. see generally supra supra see generally the cost of creating a new drug now $5 billion, pushing big pharma to change supra see generally definition of a private operating foundation supra id. id. see generally supra supra c. example: cystic fibrosis foundation collaboration with vertex pharmaceuticals phrma statement on healthcare reform coalition id. supra repurposing drugs patent tips for small pharma companies repurposing – finding new uses for old (and patented) drugs: bridging the “valley of death,” to translate academic research into new medicine supra orphan products: hope for people with rare diseases see also supra a. federal tax re-evaluation for pharmaceutical representatives supra id. id. id. kalydeco: a price too high to pay see id. see supra supra see supra id. id. dep’t of the treasury, cat. no. 11081l, travel, entertainment, gift, and car expenses see physician payment sunshine: some pharmaceutical companies reduced meal payments to health care providers id. 1. why regulate pharmaceutical promotion? b. use of modified venture philanthropy 1. utilizing private nonprofit foundations with “program-support” grants code on interactions with healthcare professionals id. id. . id. regulation of pharmaceutical promotion: why does regulation matter? id. poll: americans’ no. 1 health priority is keeping critical drugs affordable for patients, see generally supra see generally generic brand-name see definition of a private operating foundation supra taking you from idea to ind and beyond see id. supra creating own private, operating, foundations transcelerate biopharma, inc., transcelerate biopharma the orphan drug: what’s right with it supra foundations: overview ten pharmaceutical companies unite to accelerate development of new medicines id. supra transcelerate “if you want to be incrementally better: be competitive. if you want to be exponentially better: be cooperative.” private foundations indiana health law review volume xviii 2021 number 1 articles am i my cousin’s keeper? a proposal to protect relatives of genetic database subjects robert i. field,* anthony w. orlando,** & arnold j. rosoff*** i. introduction we live in a brave new world full of exciting possibilities for medical and human advancement. mapping of the genome has taken our ability to understand individual humans to a substantially more detailed and intimate level than has ever before been possible. at the same time, advances in computer science, artificial intelligence, and the universality of internet connectedness have ushered in the era of “big data” and enabled us to examine and understand as never before what all of us have in common and what makes each of us unique.1 by aggregating data from and about large numbers of people and getting a broader view of the human collective, we can understand better and in greater detail what makes for the best health and health care of an individual human, especially when we can take it down to the intimate genetic level. these advances have spawned the era of “precision medicine,” in which we can diagnose and treat human conditions and ailments with much greater effectiveness. it is a time of great possibilities but also of great perils, particularly as regards the confidentiality of each individual’s medical status and human * robert i. field, j.d., m.p.h., ph.d., is professor of law at the kline school of law, professor of health management and policy at the dornsife school of public health at drexel university, and an adjunct senior fellow of the university of pennsylvania’s leonard davis institute of health economics. ** anthony w. orlando, m.sc., m.p.w., ph.d., is assistant professor of finance, real estate, and law at the college of business administration at california state polytechnic university, pomona. *** arnold j. rosoff, j.d., is professor emeritus of legal studies and health care management at the wharton school of the university of pennsylvania and a senior fellow of penn’s leonard davis institute of health economics. the authors would like to thank the attendees of the 2019 aslme health law professors conference for their helpful comments. the authors also thank aminata jalloh for research assistance. 1. for an overview of “big data” in health care, see wullianallur raghupathi & viju raghupathi, big data analytics in healthcare: promise and potential, 2 health info. sci. & sys. art. 3 (2014). 2 indiana health law review [vol. 18:1 characteristics and potential. we can achieve miraculous things in this new world, but we must proceed with caution, sensitivity and wisdom—or we may do great and lasting damage to long-cherished notions of individual privacy. moreover, since the benefits potentially achievable depend on public trust in the data-sharing that is required, we must thread a needle between making sure that people are sufficiently aware of the risks to privacy but are not so frightened by these concerns that they shy away from informed participation in this grand endeavor. gathering, compiling, and analyzing human genetic data have become a large and growing societal enterprise. governmental and private organizations are engaging to a considerable extent, and individual citizens have jumped on the bandwagon, patronizing direct-to-consumer (“dtc”) genetic analysis services such as 23andme, ancestrydna, and the like. in all of these contexts, people are being asked to consent to various uses of their genetic data, and, being aware of the great good that can be gained from sharing that data, many are strongly motivated to do so. the enthusiasm about what we can learn and achieve is widespread and commendable, but we must take care not to throw caution to the wind. the confidentiality of personal health information is precious, and once compromised, it may be irretrievable. to take full advantage of the invaluable opportunities presented by breakthroughs in genetic understanding coupled with the potential of big data research, it is important to understand the risks and benefits of this data-sharing and what is needed—both in individuals’ own actions and those of governmental and private entities—to adequately protect personal information. what makes this situation exceptional and calls for special treatment is that sharing of genetic data not only puts the individual subject’s data privacy at risk but also that of their genetic relatives, most of whom will not know of or have any ability to affect the subject’s choices regarding how broadly to share this highly sensitive information. in this article, we propose an approach to balancing these goals so that medical science can continue its forward march while mitigating risks to the privacy we all should hold dear. section ii of our analysis examines the different contexts in which individuals’ genetic data and related bits of personal health information are gathered, compiled, and used, dividing these into three broad categories: clinical, research, and proprietary. section iii considers the potential risks to personal privacy in each category and the types of protections in place to guard against those risks. section iv focuses on the least regulated area of the genetic database ecosystem, proprietary databases, which have proliferated in recent years and for which only a minimal external regulatory oversight presently exists. section v contains our call for the creation of a new regulatory mechanism that we call “data protection review boards” (“dprb”). our concept steps off from the model of institutional review boards (“irb”) that oversee the protection of human subjects in research. dprbs would review data-sharing arrangements between database companies and other private entities with an exclusive focus on privacy risks to data subjects and their identifiable relatives. they would operate outside of formal government structures and represent a cross-section of stakeholders, including privacy experts, attorneys, ethicists, subjects, and the entities seeking to share data. we identify various key elements to be addressed 2021] am i my cousin’s keeper? 3 in their formation and operation. section vi summarizes our proposal and the need to act before individuals’ control over their information is irretrievably lost. ii. the uses and users of genetic databases not all genetic databases are created equal. organizations vary widely in their reasons for collecting genetic data, their relationship with the suppliers of the data, their planned use of those data, the value they can derive from the data, and the laws, stakeholders, norms, and expectations governing their data operations. these diverse factors create very different incentives and contexts motivating the privacy protections these organizations erect around genetic data they collect. in terms of purpose, the spectrum of genetic databases can be divided into three broad categories: clinical, research, and proprietary. each category corresponds to a qualitatively different legal framework for the collection, use, and sharing of data. we therefore use this taxonomy to distinguish databases where the law already affords a degree of privacy protection from those where we see a need for new legal protocols and safeguards. a. clinical clinical genetic databases are created and maintained to assist in the provision of health care. patients give consent for their health care providers to collect their genetic information, typically with the understanding that the data will primarily be used for their own diagnosis and treatment. these databases have opened the door to personalized precision medicine that uses genetic information to guide diagnosis and treatment and even to repair deleterious mutations in specific genes. it also permits clinicians to target therapies for specific diseases, such as cancer, and to specific pathogens, eliminating the need for blunt tools with significant side effects, such as growing resistance to broadspectrum antibiotics.2 because genes shape the body’s internal systems, they also offer the additional benefit of illuminating a person’s vulnerabilities prospectively. thus, they can be predictive as well as prescriptive, not only aiding the fight against current illnesses but also raising awareness about the risk of future threats. because of this dual nature of genetic data—informing both the present and the future—the effects of their use may extend beyond the current patientphysician relationship and treatment agenda. patients may wish to—and indeed, have a right to—know about future health risks that cannot be managed well with current treatment alone. thus, health systems are torn between ensuring that the information is used wisely under expert care and empowering patients to address their own risks on their own terms. one early adopter in the former camp is northshore university healthsystem in illinois, which has two genetic testing programs: the genetic and wellness assessment, a survey that patients take 2. megan molteni, dna tests could help docs detect infectious diseases faster, wired (oct. 22, 2018), https://www.wired.com/story/dna-sequencing-detect-infectious-disease [https:// perma.cc/k29x-spbh]. 4 indiana health law review [vol. 18:1 before their physical exam, and medcluerx, an at-home kit administered by the pharmacogenomics clinic to facilitate “gene-powered prescription.”3 these programs primarily provide doctors with information about how patients metabolize different drugs and point to further testing if needed.4 a more expansive example comes from geisinger health system in pennsylvania and new jersey, which does whole genome sequencing for all patients as part of their primary care.5 geisinger’s reporting system, genomecompass, gives information directly to consumers concerning eighty specific genes, provides even more detailed information to doctors, and connects patients with a geneticist if they desire counseling to understand their results.6 both of these health systems are atypical in their use of genetic data, however, pushing past common limitations of electronic health record interoperability and the lack of physician training in incorporating genetics into their diagnosis and treatment.7 the geisinger system goes above and beyond the current recommendations of the american college of medical genetics and genomics (“acmg”), which has been advising physicians about the communication of genetic testing results to patients since 2012.8 as of this writing, the acmg has identified fifty-nine genes that patients have a right to know about if they so choose, even though these findings may be “secondary” to their actual “diagnostic results.”9 as the list grows, so do the risks of misunderstanding and misinterpretation, with the attendant risks to health. notwithstanding this, the acmg does not recommend that genetic counseling be mandated alongside the communication of these test results, arguing that it would be too time-consuming to explain all fifty-nine findings.10 many experts have noted, however, that genes tend to cluster, making it less daunting to explain the results than the acmg’s position would make it seem.11 other critics have challenged the acmg’s “all or nothing” approach, which does not allow patients to opt out of receiving information about specific genes, giving them less “autonomous choice.”12 they also argue that the acmg encourages 3. dava stewart, genetic testing as part of primary care and precision medicine is underway at northshore university healthsystem and geisinger health, dark daily (oct. 8, 2018), https://www.darkdaily.com/genetic-testing-as-part-of-primary-care-and-precision-medicineis-underway-at-northshore-university-healthsystem-and-geisinger-health/ [https://perma.cc/3rtnajsl]. 4. id. 5. id. 6. id. 7. id. 8. susan m. wolf, the continuing evolution of ethical standards for genomic sequencing in clinical care: restoring patient choice, 45 j.l. med. & ethics 333, 333 (2017). 9. id. at 334. 10. id. at 337. 11. id. 12. id. at 334. 2021] am i my cousin’s keeper? 5 physicians to explain the risks of opting out but not the risks of opting in.13 patients may not be aware, for example, of the rate (or even the possibility) of false positives and act on the test results as if they were certain.14 they also may not be aware of the many ways their genetic data can be used against them if the data fall into the wrong hands, as we discuss in section iv below.15 clinical databases have a measure of quality control in the form of the clinical laboratory improvement amendments of 1988 (“clia”), which directs the federal department of health and human services (“dhhs”) to oversee the operation of clinical laboratories.16 such laboratories process biological samples from patients in connection with their care. the centers for medicare and medicaid services (“cms”) within the dhhs performs this function. as a result, laboratories that conduct analyses using genetic databases for patient care must meet standards that do not apply to other kinds of databases and other uses of them. b. research research genetic databases are created and maintained for scientific discovery and the development of new and improved medical practices. subjects give consent for academic, government, or private research organizations to collect their genetic information, typically with the understanding that their data will be used for scientific research to benefit society. as these databases grow, so will the statistical power of these research studies. not only will researchers be able to report their findings with greater confidence, but they will also be able to explore the heterogeneity of treatment effects, illuminating more precisely how results differ across subsamples of the populations. the more thinly they can slice the population into subsamples, the more useful their findings will become to precision medicine. to this end, the federal government has undertaken two ambitious data collection efforts: the all of us research program (“all of us”) conducted by the national institutes of health (“nih”) and the million veteran program (“mvp”) conducted by the department of veterans affairs. launched by the obama administration, each program is recruiting one million volunteers to share their personal health information, including their genetic data. all of us is especially 13. id. at 337. 14. a large body of evidence demonstrates that many, if not most, physicians are woefully unskilled at calculating, understanding, and communicating the correct probability of illness associated with a patient’s test result. see, e.g., daniel morgan, what the tests don’t show: doctors are surprisingly bad at reading lab results. it’s putting us all at risk., wash. post (oct. 5, 2018), https://www.washingtonpost.com/news/posteverything/wp/2018/10/05/feature/ doc tor s -a re -su rpr is in g ly-bad-a t -r ead in g-lab-resu lt s i t s -pu tt ing-us-all-at -r isk / [https://perma.cc/hnm9-hebw]. 15. see wolf, supra note 8. 16. 42 u.s.c. § 263a (2020). 6 indiana health law review [vol. 18:1 intended to capture historically underrepresented minorities,17 while mvp will reflect the population of veterans.18 both initiatives aim “to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care”19 and “to learn how genes, lifestyle, and military exposures affect health and illness,” respectively.20 while they are not the largest genetic databases in the country, they are likely to be among the most detailed—and therefore heavily safeguarded with privacy protections.21 unlike clinical databases, research databases do not have quality standards to ensure that the data themselves are reliable—in other words, that the laboratories are conducting high-quality tests. the clia standards only apply to clinical laboratories. as a result, the national academies of sciences, engineering, and medicine have recommended that the nih develop a “quality management system” for research laboratories that analyze human biospecimens, and once the analyses have been completed, researchers should conduct “a peerreview process to assess the risks and benefits of results disclosure.”22 whereas clinical databases are created primarily for the benefit of the patients, research databases have broader mandates, making them less likely to report the results back to the subjects who may benefit the most from them. thus, these databases have earned the moniker of “helicopter research” for dropping into people’s lives temporarily and then flying away with the valuable information they have gleaned, leaving the subjects no better off for their participation.23 c. proprietary proprietary genetic databases are created and maintained for profit, which is earned by providing testing and related services for a payment and by sharing aggregated data with other organizations for a fee. consumers give consent for companies to collect their genetic information, typically with little understanding of how their data will be used. as these databases grow, so do the opportunities for monetization. and grow they will, as this industry is projected to triple in size 17. the all of us research program investigators, the “all of us” research program, 381 new eng. j. med. 668, 668 (2019). 18. john michael gaziano et al., million veteran program: a mega-biobank to study genetic influences on health and disease, 70 j. clinical epidemiology 214, 216 (2016). 19. nat’l inst. health, https://allofus.nih.gov [https://perma.cc/5as3-892c] (last visited oct. 5, 2020). 20. million veteran program (mvp), u.s. dep’t veterans aff., https://www.research. va.gov/mvp/default.cfm [https://perma.cc/wm4n-vsad] (last visited oct. 5, 2020). 21. eric dishman, i handed over my genetic data to the nih. here’s why you should, too, stat (june 13, 2018), https://www.statnews.com/2018/06/13/entrusted-my-genetic-data-nih/ [https://perma.cc/c9p3-l6qu]. 22. nat’l acads. of scis. eng’g & med. et al., returning individual research results to participants: guidance for a new research paradigm x, xxvi (2018). 23. id. at ix. 2021] am i my cousin’s keeper? 7 over the next three years.24 the uses of proprietary databases are multitudinous, bounded not by clinical or research needs but, rather, only by the entrepreneurial limits of human imagination. the main categories of such uses are discussed below. 1. discovering genetic heritage some proprietary database companies exist to enable their customers (subjects) to use genetic testing to facilitate genealogy tracking, helping them to discover their genetic heritage. even in this seemingly most innocuous of uses, however, there can be controversy, particularly among a population that does not fully understand the science behind the results—and therefore, often, their import. the case of senator elizabeth warren, in preparation for her campaign for the united states presidency, is instructive. faced with criticism and skepticism of her claim to have native american heritage, senator warren submitted her dna to testing. the geneticist, carlos bustamante, immediately faced a data challenge: native americans are significantly underrepresented in genetic databases due in part to mistrust that their data will be misinterpreted or used for discriminatory purposes.25 as a comparison to match senator warren’s dna, bustamante substituted colombian, mexican, and peruvian dna, which he judged to be similar enough to detect her native ancestry.26 from this match, he concluded that senator warren indeed had a native american ancestor, likely from the cherokee nation tribe, approximately six to ten generations ago, giving her dna that is between 1/64th and 1/1024th native american today.27 24. tony romm & drew harwell, ancestry, 23andme and others say they will follow these rules when giving dna data to businesses or police, wash. post (july 31, 2018), https://www.washingtonpost.com/technology/2018/07/31/ancestry-andme-others-say-they-willfollow-these-rules-when-giving-dna-data-businesses-or-police/ [https://perma.cc/g82g-mhtd]. 25. see lizzie wade, to overcome decades of mistrust, a workshop aims to train indigenous researchers to be their own genome experts, sci. (sept. 27, 2018), https://www. sciencemag.org/news/2018/09/overcome-decades-mistrust-workshop-aims-train-indigenousresearchers-be-their-own [https://perma.cc/v3mr-jsnf]. 26. glenn kessler, just about everything you’ve read on the warren dna test is wrong, wash. post (oct. 18, 2018), https://www.washingtonpost.com/politics/2018/10/18/just-abouteverything-youve-read-warren-dna-test-is-wrong/ [https://perma.cc/n5cx-vks3]. 27. id. thereupon began a series of public misunderstandings and recriminations. hearing these fractions and comparing them to widely reported averages, the republican national committee claimed that “warren might even be less native american than the average european american,” which the washington post debunked as a misunderstanding of the test results—after admitting that the science was so little understood that the post itself initially endorsed a similar mistaken interpretation. id. the misunderstanding, according to the new york times science reporter whose article was taken out of context, stems from the incorrect belief that each person inherits half of their dna from each parent, one-quarter from each grandparent, and so on. carl zimmer, before arguing about dna tests, learn the science behind them, n.y. times (oct. 18, 2018), https://www.nytimes.com/2018/10/18/opinion/sunday/dna-elizabeth-warren.html 8 indiana health law review [vol. 18:1 even with this level of genetic detail, however, ancestry is only one aspect of the complicated experience that defines any social constructed ethnicity, particularly an historically oppressed minority group. the cherokee nation took offense at the implication that senator warren belonged to or spoke on behalf of their cherished history and community, reminding the country that “being a cherokee nation tribal citizen is rooted in centuries of culture and laws not through dna tests.”28 senator warren subsequently apologized, adding “i am not a person of color.”29 by then, however, it had become clear that the growth of proprietary databases had made it impossible for native americans to escape the misinterpretations and abuses that some feared when they chose not to share their data in the first place. 2. clarifying parentage the inability to hide from the magnifying glass of modern genealogy is one of the most valuable and controversial aspects of proprietary databases. once it becomes possible to identify people who do not wish to be found, their private lives can be threatened and exposed. children who were adopted or conceived with donated gametes can learn about their biological parents, even if they never met them or knew their names. on the one hand, the biological parent(s) might claim a right to remain anonymous, often based on a contract promising them anonymity when they put a child up for adoption or donated gametes. on the other hand, this anonymity can be psychologically harmful for children, severing the connection they intrinsically crave and the understanding of self that comes with such a connection. without this anonymity, however, birth parents might be more cautious about permitting their children to be adopted, and gamete donation might become less frequent. from the child’s perspective, were it not for a gamete donation, they would never have been born in the first place.30 if these acts of procreation are valuable to society, the new transparency foisted upon potential parents by proprietary databases might come with costs for future generations. complicating this tradeoff further is the potential for abuse by “search angels” who use genetic tests and other personal information to help people find their birth families. unfortunately, it is possible for unscrupulous purveyors to [https://perma.cc/fhk6-b4cq]. thus, the public assumes that those fractions accurately reflect the number of native american ancestors she had. on the contrary, she could have had—and indeed, likely did have—much more native american ancestry that simply did not get retained proportionally in her dna. 28. asthma khalid, warren apologizes to cherokee nation for dna test, npr (feb. 1, 2019), https://www.npr.org/2019/02/01/690806434/warren-apologizes-to-cherokee-nation-for-dnatest [https://perma.cc/ywq9-laf8]. 29. id. 30. dani shapiro, how a dna testing kit revealed a family secret hidden for 54 years, time (jan. 3, 2019), https://time.com/5492642/dna-test-results-family-secret-biological-father/ [https://perma.cc/345y-v24t]. 2021] am i my cousin’s keeper? 9 pose as genetic experts, take advantage of people—and their limited understanding of this new science—and tell them the wrong conclusions about their ancestry.31 if anyone deserves anonymity, it is unrelated individuals who are identified by these businesses. 3. tracking down criminal suspects no one has a greater interest in remaining anonymous than criminals. thus, proprietary genetic databases have increasingly found their way into law enforcement. the largest and most prominent databases, ancestrydna and 23andme, do not cooperate with law enforcement or share their data with public databases, but other databases are rapidly growing to fill the void.32 the most famous case involved genetic genealogist barbara rae-venter, who helped police identify joseph james deangelo as the golden state killer who committed at least fifty rapes and thirteen murders in california from 1974 to 1986.33 a retired patent attorney with a ph.d. in biology, rae-venter uploaded the suspect’s dna to the public database gedmatch, which discloses in its terms of service that it cooperates with law enforcement and that consumers are allowed to submit the dna of a third party without the person’s consent.34 thus, no court order was required.35 the sample revealed the identity of a distant cousin of the suspect.36 this enabled police to use other publicly available information to narrow the search.37 while we can applaud the detective work and celebrate the outcome, the search’s success demonstrates the ease with which a subject’s genetic data can be linked to a web of people to whom they are related.38 rae-venter is not alone. in the wake of her success, the forensic genealogy market has expanded rapidly. by august 2018, the firm parabon nanolabs claimed that they had found eight perpetrators, including the ramsey street rapist who committed at least six rapes in fayetteville, north carolina, between 2006 and 2008.39 another entrant, interfinders international, declared its intention 31. heather murphy, she helped crack the golden state killer case. here’s what she’s going to do next., n.y. times (aug. 30, 2018), https://www.nytimes.com/2018/08/29/science/ barbara-rae-venter-gsk.html [https://perma.cc/qq3h-by7a]. 32. teri figueroa, forensic genealogists shake family trees to find crime suspects, san diego union-trib. (jan. 2, 2019), https://www.sandiegouniontribune.com/news/public-safety/sdme-forensic-genealogy-20180102-story.html [https://perma.cc/2knu-efkp]. 33. id. 34. id. 35. romm & harwell, supra note 24. 36. murphy, supra note 31. 37. id. 38. ironically, rae-venter did not want the police to disclose her name to the public out of fear for her safety, even though she had no qualms about pinpointing other individuals for police scrutiny based on their genetic profiles. see id. 39. jacey fortin, in serial rape case that stumped police, genealogy database leads to 10 indiana health law review [vol. 18:1 to find suspects, heirs, and fraud.40 even ancestry, which claimed that it would not cooperate with law enforcement, admitted that it gave data to law enforcement in thirty-one out of thirty-four cases in 2017, mostly related to credit card and identify theft.41 this newfound wealth of resources overcomes the constraints that police have faced historically in accessing their own criminal databases, primarily the combined dna index system, for which they need a judge’s approval in some states. those same states do not restrict their access to public databases such as gedmatch.42 when many of these laws were written, it was nearly unimaginable that proprietary databases would become so extensive and forensic techniques so sophisticated. in maryland v. king, for instance, the supreme court ruled that dna cheek swabs did not violate the fourth amendment on the grounds that they did “not reveal an arrestee’s genetic traits.”43 six years later, researchers reported in science that they could successfully match 60% of americans of european descent to their third cousin using “anonymized” genetic data on gedmatch—and within two to three years, they predict that the match rate will increase to 90%.44 their test was less accurate for non-white americans.45 this raises two new risks for society: first, the increasing likelihood that law enforcement will have the power to view the full genetic profiles of the majority of americans, and second, the greater likelihood of error with vulnerable minorities who already have a history of mistreatment at the hands of law enforcement. these risks are at least partly mitigated when careful experts like barbara rae-venter are involved, but forensic genealogists are increasingly teaching their techniques in do-it-yourself fashion to law enforcement officials.46 what is to stop governments from abusing these new surveillance powers? for instance, authoritarian regimes could target democratic protestors and other perceived enemies, as they have done repeatedly throughout history.47 arrest, n.y. times (aug. 24, 2018), https://www.nytimes.com/2018/08/23/us/ramsey-street-rapistdna.html [https://perma.cc/mg5f-zvq6]. 40. jessica testa, nobody was going to solve these cold cases. then came the dna crime solvers., buzzfeed (sept. 22, 2018), https://www.buzzfeednews.com/article/jtes/dna-cold-casecrime-doe-project-genealogy [https://perma.cc/s68z-y6vw]. 41. 23andme, in contrast, refused all five requests that year. see romm and harwell, supra note 24. 42. heather murphy, how an unlikely family history website transformed cold case investigations, n.y. times (oct. 16, 2018), https://www.nytimes.com/2018/10/15/science/ gedmatch-genealogy-cold-cases.html [https://perma.cc/s749-6b2u]. 43. maryland v. king, 569 u.s. 435, 438 (2013). 44. yaniv erlich et al., identity inference of genomic data using long-range familial searches, 362 sci. 690, 690-94 (2018). 45. id. at 690. 46. murphy, supra note 31. 47. noa yachot, history shows activists should fear the surveillance state, aclu (oct. 2021] am i my cousin’s keeper? 11 4. identifying unidentified bodies even when individuals do not seek anonymity, proprietary databases can implicate others. the dna doe project, for example, has tried to avoid controversy by helping law enforcement identify innocent individuals—namely, unidentified dead bodies—who are not at risk of harm, but complications can still arise. what happens when they deduce the identity of a dead baby, leading law enforcement to find the mother? unintentionally, they have identified a suspect in the child’s death and disposal—a suspect who did not consent to the use of her genetic information by law enforcement.48 and how do the families of the deceased know that they can trust the traumatic news they are receiving from this squad of volunteer genealogists? while genealogy has professional certification, genetic genealogy does not.49 the genetic genealogist’s findings do not come with any independent screening ex ante or verification ex post. 5. finding lost relatives the risks are no less profound for users who seek to locate lost relatives and reunite families. though the aim once again can be admirable, the execution opens the door to new threats. for this reason, 23andme and myheritage encountered significant public criticism when they donated genetic testing kits to the trump administration to help them return immigrant children to their parents.50 especially in an administration hostile to immigrant rights, it is possible to imagine genetic data being used to track and discriminate against individuals long after they have left government custody. officials were never required to prove that genetic testing was more effective than the collection of names, documents, and photographs that they were already using; rather, it normalized a more extensive system of data collection without evidence of its effectiveness. reliance on genetic profiling may even work against reunification in cases where the guardians are not genetic relatives. all the while, these data are being collected without informed consent, which is impossible to get from young children separated from their guardians.51 though genetic testing has been used successfully to reunite families in other countries, some of those same countries, such as china and kuwait, have used their new data collection capabilities to target marginalized ethnic groups.52 the threat is real. 27, 2017), https://www.aclu.org/blog/national-security/privacy-and-surveillance/history-showsactivists-should-fear-surveillance [https://perma.cc/wry6-ezcj]. 48. testa, supra note 40. 49. id. 50. ava kofman, dna testing might help reunite families separated by trump. but it could create a privacy nightmare., intercept (june 27, 2018), https://theintercept.com/2018/06/ 27/immigration-families-dna-testing/ [https://perma.cc/274r-chg2]. 51. id. 52. id. 12 indiana health law review [vol. 18:1 6. proprietary uses for clinical because there are so few restrictions on the uses to which these databases may be directed, it is not surprising to find the line blurring between proprietary and non-proprietary. virtually all personal health information got into a patient’s records through the actions of members of the health care team and those who worked closely with them. however, others can be involved, as well. for example, a partnership between 23andme and the michael j. fox foundation has offered free testing to 10,000 people with parkinson’s disease, releasing data to third parties outside the medical system.53 at least when genetic tests are ordered by physicians, as in the partnership between ancestry and the diagnostic testing group pwnhealth, cms has regulatory authority.54 to date, however, its intervention has been minimal. cms does not require that doctors report results for all fifty-nine genes recommended for analysis by the acmg but rather only results for seventeen genes. it does not consider whether patients overestimate the importance of these genes or even have the capacity to understand the nuances of the results. it does not recommend best practices to deliver emotionally challenging news, beyond the online videos and access to genetic counselors that most doctors already provide. of course, such recommendations would be difficult to devise, since experts have not yet determined which practices are best for communicating this nascent form of health information.55 7. proprietary uses for research the same line-blurring is evident in research, which has become especially lucrative for some proprietary database companies. the most active participant appears to be 23andme, largely due to the size of its database and the fact that 80% of its consumers have consented to the use of their genetic data for research.56 it has entered into more than fifty academic collaborations, including a $60 million deal with genentech,57 a $300 million deal with glaxosmithkline,58 and partnerships with alnylam pharmaceuticals, biogen, janssen, lundbeck, and pfizer.59 by 2015, the average customer’s genome had already been used in 230 53. valerie gutmann koch & kelly todd, research revolution or status quo?: the new common rule and research arising from direct-to-consumer genetic testing, 56 hous. l. rev. 81, 93 (2018). 54. 42 c.f.r. § 410.32 (2020). 55. see matthew herper, ancestry launches consumer genetics tests for health, intensifying rivalry with 23andme, stat (oct. 15, 2019), https://www.statnews.com/2019/ 10/15/ancestry-health-launch/ [https://perma.cc/6ctc-hula]. 56. jennifer abbasi, 23andme, big data, and the genetics of depression, 317 jama 14, 15 (2017). 57. id. 58. romm & harwell, supra note 24. 59. molteni, supra note 2. 2021] am i my cousin’s keeper? 13 different studies.60 just as significant, if not more so, as part of its research collaborations 23andme asks those who have provided genetic material and consented to the use of their genetic data to also answer extensive surveys about their health status, co-morbidities, diet, lifestyle, sexual orientation, mentalemotional state, and other intimate personal matters.61 these surveys also contain many questions about whether the responder’s family members have or have had certain health characteristics and conditions. this is necessary for fully meaningful genetic analysis because health effects are the product of not only one’s genetic makeup but also environmental factors, including how that person lives their life. on another point of concern, experts have questioned the validity of some of the findings of these collaborations, since companies such as 23andme do not examine patients in a traditional clinical or research setting—but rather tend to rely on self-reported measures, which have high error rates.62 in an extensive survey questionnaire to which one of the authors responded for one commercial database, a large number of questions asked for specifics of past illnesses and conditions and indicated that, if the responder could not provide exact information, a “best guess” would be sufficient. despite these concerns, research based on commercial genetic databases is proliferating. a survey of the medical literature from 2011 to 2017 found 181 publications that used private genetic data, with the annual publication record growing from four to fifty-seven studies per year over that time period.63 of these publications, 86% had an academic collaborator, and 45% had nih funding, signifying just how far proprietary genetic databases have crossed the line into the established world of academic research.64 iii. genetic exceptionalism: special threats to privacy from time to time in the course of technological progress, it becomes necessary to update our concept of the right to privacy. when in 1888 george eastman introduced the world to his new “snap camera,” he placed into the hands of each consumer the power to record, to preserve, and thus to distribute every visible moment, no matter how fleeting or acontextual, with all the embarrassment, indignity, or incrimination it might arouse. it was partly in response to this new temptation that samuel warren and louis brandeis penned 60. michael grothaus, how 23andme is monetizing your dna, fast company (jan 5, 2015), https://www.fastcompany.com/3040356/what-23andme-is-doing-with-all-that-dna [https:// perma.cc/xj94-hy9y]. 61. see 23andme research surveys and questions, 23andme, https://customercare.23andme. com /h c/ en -u s / a r t ic les /2 1 2 8 8 1 9 7 7 -2 3 andme-research-surveys-and-qu es t ion s [https://perma.cc/8ptr-hvwl] (last visited nov. 12, 2020). 62. abbasi, supra note 56. 63. kayte spectator-bagdady et al., genetic data partnerships: academic publications with privately owned or generated genetic data, 21 genetics med. 2827, 2828 (2019). 64. id. 14 indiana health law review [vol. 18:1 their famous treatise on the right to privacy, wherein they described this new right as an emergent application of other rights long enshrined in the common law.65 we begin our investigation of genetic privacy with this classic formulation, and we show how it is insufficient to address the risks of the technologies in our own time. from there, we propose a new concept of privacy, constructed to guard against four potential harms that may befall genetic relatives who are unwittingly ensnared in the database’s grasp: wrongful publicity, discrimination, expropriation of profit, and violation of public trust. a. toward a new concept of privacy “that the individual shall have full protection in person and in property is a principle as old as the common law,” write warren and brandeis, and therein do they find many aspects of the right to privacy already in force.66 in intellectual property rights, they find protection against publishing what creators do not want published without agreed-upon compensation.67 in the fifth amendment, they find the right not to express personal thoughts.68 in the rights not to be assaulted or defamed or imprisoned without due process—violations that all have “the quality of being owned or possessed”—they find the right “to be let alone.”69 if “[t]he common law has always recognized a man’s house as his castle, impregnable,” they argue, then surely that inviolability extends not just to physical intrusions but also to the intrusions of “idle or prurient curiosity.”70 when these words were written in 1890, it was possible to draw a direct line from each privacy violation to the individual being harmed. when a voyeur peers into a man’s house, he sees only the contents of that one house. he does not see into the man’s neighbor’s house or his cousin’s or his distant relative’s in a faraway land. when the state imprisons someone, its jail cells do not fill up with that person’s entire extended family. when a person is assaulted, there are no bruises or broken bones to be found anywhere else in his family tree. the right to privacy, as originally conceived and applied, was meant to protect the individual alone. it did not envision a technological context that would allow a person to reveal what many other people might not want revealed, a secret so buried that this person does not even know that they are revealing it—indeed, that the revealer does not even know that the secret exists. the technology here is the ability to collect and analyze genetic information, and the intrusion it allows is not just individual but, rather, collective. to guard against this intrusion, it is not enough to require the consent of the person who owns the property or volunteers the information, as in the case of intellectual property rights or the fifth 65. see samuel d. warren & louis d. brandeis, the right to privacy, 4 harv. l. rev. 193 (1890). 66. id. at 193. 67. see id. at 200-03. 68. see id. at 198-99. 69. id. at 205 70. id. at 220. 2021] am i my cousin’s keeper? 15 amendment or the homeowner opening their door to prying eyes. for contained within those hidden truths are someone else’s hidden truths, and by warren and brandeis’s logic, the same “full protection” must apply to their person and property as well.71 the common law has advanced considerably in this direction in recent decades. although it does not yet recognize a collective right to privacy, it acknowledges a person’s “reasonable expectations of privacy” as a standard to be protected by the state. this test, famously articulated by justice harlan in his concurring opinion in katz v. united states, requires that the person “have exhibited an actual (subjective) expectation of privacy and . . . that the expectation be one that society is prepared to recognize as ‘reasonable.’”72 a decade later, the court applied constitutional protection to information privacy, extending the reasonable expectations standard to “the individual interest in avoiding disclosure of personal matters.”73 by these standards, genetic information is a strong candidate for privacy protection. it is one of the most personal matters in one’s life, both in substance—dna, the body’s fundamental building blocks, the very essence of one’s existence—and in content—revealing everything from detailed family history to the most serious medical conditions. the public has exhibited its expectation of genetic privacy through legislation, contractual agreements, and public opinion polls.74 all that remains to establish a collective right to privacy is a demonstration that society ought to recognize these expectations as “reasonable,” not only for the individual giving the dna sample but for everyone else implicated by genetic relation. in the remainder of this section, we make this case by enumerating the potential harms that warrant such expectations of privacy. b. wrongful publicity the same technological advances that allow the health care system to collect greater quantities of genetic information simultaneously create more possibilities for criminals to steal and expose that genetic information. data privacy laws vary widely across states, leaving millions of americans far less protected than they could be.75 even if data managers deidentify the data, cyber experts have found 71. id. at 193. 72. katz v. united states, 389 u.s. 347, 361 (1967). 73. whalen v. roe, 429 u.s. 589, 599 (1977). 74. see, e.g., christi j. guerrini et al., should police have access to genetic genealogy databases? capturing the golden state killer and other criminals using a controversial new forensic technique, 16 plos biology art. e2006906 (2018); see also scott hensley, poll: genealogical curiosity is a top reason for dna tests; privacy a concern, npr (june 1, 2018), https://www.npr.org/sections/health-shots/2018/06/01/616126056/poll-genealogical-curiosity-is-atop-reason-for-dna-tests-privacy-a-concern [https://perma.cc/g68j-qcr2]. 75. see karen turner, the equifax hacks are a case study in why we need better data breach laws, vox (sept. 14, 2017), https://www.vox.com/policy-and-politics/2017/9/13/ 16 indiana health law review [vol. 18:1 that it is possible to reidentify much of it, a problem of which most americans are not aware.76 genetic data theft takes this problem even farther than other data theft; while a medical identification number or a credit card number may change, a person’s genome will stay with them to the day they die.77 wrongful exposure of this kind is harmful in several ways. human beings typically cannot establish “a close, relaxed, and frank relationship” without some degree of intimacy.78 they strategically expose their information as a relationship deepens as a way to signal the importance they place on the person and the moment at hand.79 by depriving them of the ability to control this exposure—control over the very identity they wish to create themselves— wrongful publicity robs them of this careful construction of fragile relationships. people may interact less, experiment with ideas less, and express their emotions less in a community where they do not feel that their persona is safe and accepted by the other members of the community.80 if they cannot know what others know about them—and this is particularly true of genetic databases where they are tracked through distant relatives—then, in the words of one author, they are being “deliberately deceive[d] . . . about [their] world.”81 for these reasons, the restatement (second) of torts recognizes four privacy torts related to wrongful publicity: public disclosure of private facts, intrusion upon seclusion, the “false light” in which publicity puts a person, and appropriation of someone’s “name or likeness.”82 any violation typically must rise to the level of being “highly offensive to a reasonable person.”83 examples include disclosing membership in a political group formed under the first amendment’s freedom of association clause,84 publicizing the names of abortion patients or in vitro fertilization patients,85 and even subpoenaing deidentified late-term abortion records.86 in the latter case, a federal appellate court ruled that the data could be identified by “persons of their acquaintance, or 16292014/equifax-credit-breach-hack-report-security [https://perma.cc/59zz-8b2r]. 76. scott r. peppet, regulating the internet of things: first steps toward managing discrimination, privacy, security, and consent, 93 tex. l. rev. 85, 128 (2014). 77. jennifer kulynych, is privacy the price of precision medicine?, oupblog (mar. 26, 2017), https://blog.oup.com/2017/03/privacy-precision-medicine/ [https://perma.cc/cl8k-jdy7]. 78. alan f. westin, privacy and freedom 31 (1967). 79. see julie e. cohen, examined lives: informational privacy and the subject as object, 52 stan. l. rev. 1373 (2000). 80. westin, supra note 78; see also paul m. schwartz, property, privacy, and personal data, 117 harv. l. rev. 2055 (2004). 81. stanley i. benn, privacy, freedom, and respect for persons, in nomos xiii: privacy 10 (1971). 82. restatement (second) of torts § 652 (am. law inst. 1977). 83. id. 84. naacp v. alabama, 357 u.s. 449 (1958); shelton v. tucker, 364 u.s. 479 (1960). 85. doe v. mills, 536 n.w.2d 824 (mich. ct. app. 1995); y.g. v. jewish hosp. of st. louis, 795 s.w.2d 488 (mo. ct. app. 1990). 86. nw. mem’l hosp. v. ashcroft, 362 f.3d 923 (7th cir. 2004). 2021] am i my cousin’s keeper? 17 skillful ‘googlers,’”87 a concern that can apply equally to family history and other genetic information. the court observed: even if there were no possibility that a patient’s identity might be learned from a redacted medical record, there would be an invasion of privacy. imagine if nude pictures of a woman, uploaded to the internet without her consent though without identifying her by name, were downloaded in a foreign country by people who will never meet her. she would still feel that her privacy had been invaded.88 it is not too far of a stretch to imagine a future where her genetic information will allow that same foreign voyeur to construct an even more detailed portrait of her than just a few nude photos. c. discrimination in 1924, dr. albert sidney priddy petitioned the virginia state colony for epileptics and feebleminded to forcibly sterilize an 18-year-old, mentally deficient inmate named carrie buck.89 in an 8-1 decision, the supreme court ruled in favor of dr. priddy and upheld the virginia law that authorized the sterilization.90 justice oliver wendell holmes jr. argued in the majority opinion that the “public welfare” was more important than buck’s right to procreate.91 she was, he said, too “promiscuous,” as her mother before her had been and, he predicted, her daughter after her, leading to his famous conclusion: “three generations of imbeciles are enough.”92 although buck v. bell has been widely criticized over generations, it has never been expressly overturned by the supreme court. the bygone logic of eugenics may seem repugnant by modern standards, but the crusade to discriminate against undesirable genes continues to this day. consider the case in 1998 when the lawrence berkeley laboratory tested job applicants for sickle cell trait without their knowledge.93 or in 1999 when terri sergeant was fired one month after her employer learned of her genetic disposition for lung disease—the firm’s health plan was self-insured.94 or in 2001 when a company was sued for discriminating against workers who were “more likely” to develop carpal tunnel syndrome.95 this initial suit was dismissed 87. id. at 929. 88. id. 89. buck v. bell, 274 u.s. 200, 205 (1927). 90. id. at 207-08. 91. id. at 207. 92. id. 93. norman-bloodsaw v. lawrence berkeley lab., 135 f.3d 1260 (9th cir. 1998). 94. anita silvers & michael ashley stein, human rights and genetic discrimination: protecting genomics’ promise for public health, 31 j.l. med. & ethics 377, 380-82 (2003). 95. eeoc v. woodbridge corp., 263 f.3d 812, 813 (8th cir. 2001). 18 indiana health law review [vol. 18:1 because genetic discrimination itself was not illegal at the time.96 these incidents are not isolated. research shows that a significant percentage of individuals with a genetic predisposition for huntington’s disease experience discrimination in employment (6.5%), insurance (25.9%), and relationships (32.9%).97 across north america, a genetic test revealing sudden arrhythmia death syndromes is associated with a 60% likelihood of being rejected by insurers (disability, health, life, or travel)—and for those who do get insurance, a 39% likelihood of higher premiums.98 in one survey, 46% of respondents worried that genetic testing would lead to stigmatization based on the resulting diagnoses, leading many of them to consider avoiding it.99 they have good reason to be concerned. the history of health care is replete with dangerous, damaging, ill-informed stigmas. hiv-related stigma is so severe that it leads to a significant increase in depression and alcohol abuse in patients.100 it is so pervasive that researchers have created a global hiv stigma index to track it over time,101 and courts have ruled that hiv-related disclosures “cause a violation of the family’s privacy much greater than simply revealing any other aspect of their family medical history.”102 but medical problems and a genetic predisposition to such problems need not rise to the level of hiv infection to expose a person to potential discrimination. despite statutory protections against discrimination discussed in section iv below,103 cancer survivors report experiencing negative stereotypes in the workplace about their ability to do their job, their productivity and reliability, and the future cost of their illness to the company.104 if they apply for a new job, they are less likely to be viewed as 96. see eeoc v. woodbridge corp., 124 f. supp. 2d 1132, 1139 (2000). discrimination in employment or insurance on the basis of one’s genetic makeup has been outlawed by the genetic information nondiscrimination act of 2006. see discussion infra section iv(a)(1). 97. cheryl erwin et al., perception, experience, and response to genetic discrimination in huntington disease: the international respond-hd study, 153b am. j. med. genetics part b 1081, 1082 (2010). 98. saira mohammed et al., genetic insurance discrimination in sudden arrhythmia death syndromes: empirical evidence from a cross-sectional survey in north america, 10 circulation: cardiovascular genetics (2017), at 1, https://www.ahajournals.org/doi/pdf/ 10.1161/circgenetics.116.001442 [https://perma.cc/f5np-rljv]. 99. davit chokoshvili et al., public views on genetics and genetic testing: a survey of the general public in belgium, 21 genetic testing & molecular biomarkers 195, 195 (2017). 100. see kaylee b. crockett et al., experiences of hiv-related discrimination and consequences for internalised stigma, depression and alcohol use, 34 psychol. & health 796 (2019). 101. barbara a. friedland et al., measuring intersecting stigma among key populations living with hiv: implementing the people living with hiv stigma index 2.0, 21 j. int’l. aids soc’y 115, 115 (2018). 102. doe v. barrington, 729 f. supp. 376, 385 (d.n.j. 1990). 103. see discussion infra section iv. 104. mary stergiou-kita et al., the “big c” – stigma, cancer, and workplace discrimination, 10 j. cancer survivorship 1035, 1035 (2016). 2021] am i my cousin’s keeper? 19 competent, with significantly negative hiring results.105 although the majority of the population does not appear to discriminate against cancer patients or survivors, the rate is high enough to represent a significant challenge for anyone trying to get a mortgage (31%), receive “the best possible care” (17%), and even feel accepted in normal social situations (17%).106 because genetic testing can reveal predispositions for many types of cancers, it exposes the patient to all of these risks, as well as innumerable others. unlike a single diagnosis, a genetic test is a pandora’s box of potential risk factors, introducing more stigmas than are even known to exist yet. it is not hyperbole, therefore, to agree with jessica roberts that we risk creating a future world with a “genetic underclass.”107 d. expropriation of profit historically, patients and research subjects have not had ownership rights in their biological specimens once extracted from their bodies or in any resulting personal health information. once extracted, the specimens and data belong to the organization, whether a university, hospital, or research institute, that collects them. the data are the organization’s to sell, share, or use for research purposes. the “donors” no longer have the right to access their own data, to exclude others from accessing them, or to commercialize them. therefore, courts have found that they are not entitled to a share in the profits earned from research that uses those data.108 john moore famously challenged this commercialization when the ucla medical center created and patented a profitable cell line using t-lymphocytes that were collected from his spleen, which was removed as part of his treatment for hairy-cell leukemia.109 moore characterized this use of his biological samples as a conversion, an unlawful expropriation of personal property, arguing that the doctor, his assistant, ucla, a related genetics institute, and the sandoz pharmaceutical company had violated his property rights.110 the supreme court of california disagreed.111 in their judgment, patients do not have an ownership 105. larry r. martinez et al., selection bias: stereotypes and discrimination related to having a history of cancer, 101 j. applied psychol. 122, 122-23 (2016); see also mary stergioukita et al., stigma and work discrimination among cancer survivors: a scoping review and recommendations, 84 canadian j. occupational therapy 178 (2017). 106. charlotte vrinten et al., cancer stigma and cancer screening attendance: a population based survey in england, 19 bmc cancer art. 566 (2019), at 1. 107. jessica l. roberts, the genetic information nondiscrimination act as an antidiscrimination law, 86 notre dame l. rev. 597, 597 (2011) [hereinafter the genetic information nondiscrimination act]. 108. see jessica l. roberts, progressive genetic ownership, 93 notre dame l. rev. 1105 (2018) [hereinafter progressive genetic ownership]. 109. moore v. regents of univ. of cal., 51 cal.3d 120, 125-29 (cal. 1990). 110. id. 111. id. at 125. 20 indiana health law review [vol. 18:1 interest in their body parts after removal.112 in contrast to a wrongful-publicity case where a person retains an ownership interest in their own unique likeness, wrote justice edward panelli for the majority, “the particular genetic material which is responsible for the natural production of lymphokines . . . is no more unique to moore than the number of vertebrae in the spine or the chemical formula of hemoglobin.”113 federal patent law reinforces this perspective, bestowing protection on “the product of ‘human ingenuity,’ but not naturally occurring organisms.”114 the goal of ownership, in this view, is to reward “inventive effort . . . not the discovery of naturally occurring raw materials.”115 of course, there are other reasons for property rights. people may not be able to patent naturally occurring raw materials, but they certainly cannot mine them without the consent of the owner of the mine. here, ownership does not serve to reward “inventive effort” but rather to protect the land from unproductive use and unrestrained exploitation—to prevent a “tragedy of the commons.”116 by analogy, we can understand why justice stanley mosk dissented that “scientists or industrialists” ought not to have “the right to appropriate and exploit a patient’s tissue for their sole economic benefit the right, in other words, to freely mine or harvest valuable physical properties of the patient’s body.”117 imagine how much more widespread this exploitation becomes when they can appropriate and exploit valuable property from not just one patient but, rather, from dozens or even hundreds with a single sample from a single genetic test. nor is uniqueness a necessary qualification for ownership. in most supply chains in most industries, the inputs are homogeneous. one brick is the same as another brick, one barrel of oil identical to the next. we do not deny the suppliers their fair recompense because they lack originality. on the contrary, we reward them for supplying these necessary inputs and give them an incentive to supply even more in the future. we discourage theft. why should a hammer or a nail be more deserving of compensation than the human genome? we shudder to think of the possibility that research subjects might fail to supply the inputs we need for lifesaving experiments. as justice allen broussard noted in partial dissent, why should they not demand a say in what happens to their donation, just as organ donors have in transplantation?118 it is not clear, however, that property law is the best way to resolve these challenges. there is a difference between a thing and what information we can 112. id. at 153-54. 113. id. at 139. while this may be true as a legal matter, it was the special physical properties of moore’s t-lymphocytes that made them uniquely valuable. thus, they were unique in a physical sense. 114. id. at 141-42. 115. id. at 142 (emphasis omitted); see also diamond v. chakrabarty, 447 u.s. 303 (1980) (holding that genetically modified living organisms can be patented). 116. for the modern formulation of our understanding of this problem, see garrett hardin, the tragedy of the commons, 162 sci. 1243 (1968). 117. moore, 51 cal.3d at 174 (mosk, j., dissenting). 118. id. at 154-55 (broussard, j., concurring and dissenting). 2021] am i my cousin’s keeper? 21 learn from the thing. as james boyle points out, “i could stare at my genetic code all day and not even know it was mine.”119 but someone else could, and boyle cannot begin to fathom what that person might come to know about him. property law is not designed to protect him from this revelation. only privacy serves to prevent “disclosure of intimate, embarrassing, or simply ‘personal’ socially constructed facts about ourselves,” especially when those facts are unknowable to the person donating the “property.”120 a patient like moore might have more control over the future use of his body parts, for example, if the physician disclosed the potential profitmaking opportunities prior to donation. moore’s physicians did not, and the court ruled that they breached their fiduciary duty and failed to obtain informed consent as a result.121 as justice mosk points out, however, these particular privacy protections do not “reach a major class of potential defendants: all those who are outside the strict physician-patient relationship with the plaintiff.”122 nor do they reach a major class of potential plaintiffs, though justice mosk could not have known this given the early state of genetics at the time. we know that moore is not the only person whose genetic information is contained in his biological samples. in fact, his data are so valuable precisely because they implicate so many different people with common genetic characteristics. the profit is in the collective. e. violation of public trust americans have been losing faith in collective institutions for over four decades.123 nevertheless, the medical profession still ranks high on measures of public trust.124 this trust is critical to the success of the health care system. patients who do not trust physicians are less likely to go to regular checkups, get necessary treatments, or take critical medication.125 they may dissuade others from engaging with the health care system, and they may turn to dangerous alternative treatments instead. a decline in trust on par with other collective institutions could trigger nothing short of a public health crisis. 119. james boyle, shamans, software, and spleens: law and the construction of the information society 105 (1996). 120. id. (emphasis added). 121. moore, 51 cal.3d at 148. 122. id. at 180 (mosk, j., dissenting). 123. bill bishop, americans have lost faith in institutions. that’s not because of trump or “fake news.,” wash. post (mar. 3, 2017), https://www.washingtonpost.com/posteverything/wp/ 2017/03/03/americans-have-lost-faith-in-institutions-thats-not-because-of-trump-or-fake-news/ [https://perma.cc/4e89-n2ka]. 124. cary funk et al., trust and mistrust in americans’ view of scientific experts, pew res. ctr. (aug. 2, 2019), https://www.pewresearch.org/science/2019/08/02/trust-and-mistrust-inamericans-views-of-scientific-experts/ [https://perma.cc/e2wf-hvfu]. 125. see johanna birkhäuer et al., trust in the health care professional and health outcome: a meta-analysis, 12 plos one art. e0170988 (2017). 22 indiana health law review [vol. 18:1 confidentiality is a critical component of this trust. patients need to feel comfortable divulging their most personal, intimate, and sometimes embarrassing details in order to arm their physician with the necessary information to diagnose, treat, and advise them. the supreme court has recognized that this type of “confidential relationship [is] necessary for successful treatment” in psychotherapy, as in other forms of medical practice.126 that is why, as far back as the hippocratic oath, physicians have sworn that they “will not divulge . . . all [that] should be kept secret,”127 and a majority of american states have enshrined this principle in law as a “physician-patient privilege.” imagine how many more people might be scared away from the medical system if they learn that their information is being abused even before they volunteer it because they are genetically related to someone who donated to a proprietary database. this is a likely outcome if they witness the other harms we have discussed in this section. already there are reports that african-americans are opting out of genetic testing because they fear police abuse,128 and we saw the concerns of native americans come true in the elizabeth warren case described in section i above. law enforcement already ranks low on the surveys of public trust, and we can see how that tension spills over into community relations, public safety, and the resulting negative effects on residents.129 do we want to see the same damage done to our health care system, the same retreat from our research studies, the same fear, the same questioned motives? iv. current genetic privacy protections and their limitations in this new and broader landscape of vulnerability to privacy invasions based on genetic information, existing legal protections are based on a patchwork of laws that leave substantial gaps. the most important ones were written decades ago, when genetic databases and their uses were but a distant vision. the major laws can be divided into two main categories: (1) restrictions on use, which proscribe certain uses of information once it has been obtained, and (2) restrictions on access, which limit the persons or entities with whom data may be shared and under what circumstances. their coverage falls far short of being comprehensive, and some important risks remain unaddressed. 126. jaffee v. redmond, 518 u.s. 1, 10 (1996) (footnote omitted). 127. quoted in daniel j. solove & paul m. schwartz, information privacy law 483 (5th ed. 2015). 128. amy dockser marcus, for some african-americans, genetic testing reopens past wounds, wall street j. (july 14, 2018), https://www.wsj.com/articles/for-some-africanamericans-genetic-testing-reopens-past-wounds-1531566000 [https://perma.cc/25fe-7ddv]. 129. see andrew mccall, resident assistance, police chief learning, and the persistence of aggressive policing tactics in black neighborhoods, 81 j. pol. 1133 (2019); see also cheryl boudreau et al., police violence and public perceptions: an experimental study of how information and endorsements affect support for law enforcement, 81 j. pol. 1101 (2019). 2021] am i my cousin’s keeper? 23 a. use restrictions 1. the genetic information nondiscrimination act the move to ban discrimination based on a person’s genetic makeup was not immediate or unanimous. from the time the first genetic antidiscrimination bill was introduced in congress in 1994, it took fourteen years to get the majority of both chambers onboard. the business community worried about the cost of frivolous lawsuits. insurance companies worried about losing their underwriting ability, predicting adverse selection and rising costs to consumers.130 opponents even argued the law would prevent patients from learning about genetic tests that could save their lives. the most significant challenge to enacting a law, however, was the lack of evidence that genetic discrimination was, in fact, a real and serious risk. in general, law is a response to felt needs; society must perceive a problem, or at least share a strong sense that a problem is imminent, before it is moved to enact a law to correct or head off the problem. situations in which some are foresighted enough to anticipate an approaching problem and persuasive enough to convince others of the need to take prospective preventative action are rare. the early emergent concern about genetic discrimination is one example of this cultural phenomenon. the genetic information nondiscrimination act (“gina”) was finally passed by congress in 2008.131 it prohibits discrimination in health insurance and in employment for firms with fifteen or more employees.132 its health insurance protection was rendered largely superfluous by the patient protection and affordable care act (“aca”), which was enacted two years later133 and prohibits insurers from excluding people from coverage because of preexisting health conditions, and it does not apply to other forms of insurance, such as those covering disability, life, and long-term care.134 previous antidiscrimination laws had been retrospective. the civil rights 130. “underwriting” in insurance is the process of identifying and evaluating the various risk factors and deciding the appropriate premium to charge for covering the risk, or whether to issue coverage at all. the aca’s prohibition against excluding pre-existing conditions from coverage goes against generations of insurance industry theory and practice. without the protections afforded by the aca and gina, the risk of genetic discrimination would be a clear and present danger. see arnold j. rosoff & anthony w. orlando, employers and health insurance under the affordable care act, 24 annals health l. 470 (2015). 131. 42 u.s.c. ch. 21f (2020). 132. what is genetic discrimination?, medlineplus, https://medlineplus.gov/genetics/ understanding/testing/discrimination/ [https://perma.cc/l4nr-chle] (last visited nov. 12, 2020). 133. if either congress or the supreme court were to nullify the aca’s prohibition of discrimination in health insurance on the basis of having a pre-existing condition, gina would, of course, no longer be superfluous in this regard. 134. what is genetic discrimination?, supra note 132. 24 indiana health law review [vol. 18:1 act,135 the age discrimination in employment act,136 the rehabilitation act,137 and the americans with disabilities act (“ada”)138 each sought to end a form of discrimination that had a long history. with a few exceptions, genetic testing was too new, too undeveloped, and too limited to have a history of abuse. gina was therefore preemptive. it envisioned the kinds of discrimination that could happen and attempted to prevent them ex ante. to its supporters, this approach was admirably foresighted; to its detractors, it was a recipe for unintended consequences.139 this unique context led, in part, to a unique design. the history of discrimination has created subordinated groups, leading congress to craft “antisubordination” statutes like the civil rights act that go beyond merely outlawing negative differential treatment. these laws actually allow positive differential treatment to uplift the subordinated groups. after decades of inequality, they recognize that discrimination is built into the system in ways that are often not obvious. as a result, they allow “disparate impact” actions where claimants can challenge policies that have discriminatory effects even if intentional discrimination against the claimants cannot be established. gina, in contrast, does not yet have an overtly recognizable “genetic underclass” to protect. it therefore prohibits employers and health insurance companies from classifying people with respect to genetic information.140 this type of “anti-classification” statute only prevents negative differential treatment and allows “disparate treatment” actions only where it is clear that the claimants have been intentionally targeted.141 because of its limited scope, gina allows any kind of genetic discrimination not explicitly listed in the law, including education, housing, insurance other than health coverage, and mortgage lending. had carrie buck lived in the age of gina, it would not have protected her from sterilization, since reproductive rights are not mentioned in the law.142 for that matter, no actual health conditions are covered by the law.143 once a genetic predisposition develops into an actual illness, gina no longer applies.144 2. the americans with disabilities act the ada, passed in 1990, prohibits discrimination based on disability in 135. civil rights act of 1964, pub. l. no. 88-352, 78 stat. 241. 136. age discrimination in employment act of 1967, pub. l. no. 90-202, 81 stat. 602. 137. rehabilitation act of 1973, pub. l. no. 93-112, 87 stat. 355. 138. americans with disabilities act of 1990, pub. l. no. 101-336, 104 stat. 327. 139. see jessica l. roberts, preempting discrimination: lessons from the genetic information nondiscrimination act, 63 vand. l. rev. 439 (2010). 140. see what is genetic discrimination?, supra note 132. 141. the genetic information nondiscrimination act, supra note 107, at 633. 142. see 42 u.s.c. ch. 21f (2020). 143. see id. 144. id. 2021] am i my cousin’s keeper? 25 employment and “public accommodations,” which include most facilities and services available to members of the public.145 job offers, promotions, and other terms of employment may not be denied or curtailed because of a disability.146 the same applies to a denial or limitation of access to a private or governmental facility, such as an office, store, entertainment venue, hotel, or hospital.147 furthermore, employers and proprietors must make “reasonable accommodations” to enable a disabled person to perform a job or access a facility.148 what is “reasonable” in this regard is generally assessed in terms of cost.149 a disability is defined as a condition that substantially limits one or more major life activities, having a history or record of having such a condition, or being perceived as having one.150 major life activities are defined by regulations to include major functional capabilities, such as walking, standing, speaking, and concentrating.151 they also include major physiologic functions, such as immune response, digestion, brain activity, circulatory function, endocrine function, and reproduction.152 a substantial limitation in these and similar functions triggers the ada’s protections. the ada would clearly protect an individual with a genetic trait that limits a major life function and has manifested itself.153 however, the protection afforded to an individual with a trait that merely confers an enhanced probability of developing such a limitation in the future is less clear. an employer’s concern over a current or prospective employee’s enhanced probability of developing a genetic condition may trigger the law’s protections for individuals perceived as having a disability, but the courts have required that the perception must concern “a substantially limiting impairment,” not the predisposition to incur such an impairment.154 although the law was amended in 2008 to expand the definition of disability in response to these decisions, it still does not cover discrimination based solely on a genetic trait in an individual who is asymptomatic.155 therefore, should an employer acquire genetic information on a current or prospective employee suggesting that they stand an enhanced probability of developing a disability in the future, the ada would offer no protection should the employer 145. americans with disabilities act of 1990, pub. l. no. 101-336, 104 stat. 327. 146. see id. 147. see id. 148. id. 149. see id. 150. 42 u.s.c. § 12102(1) (2020). 151. 42 u.s.c. § 12102(2)(a) (2020). 152. 42 u.s.c. § 12102(2)(b) (2020). 153. see 42 u.s.c. § 12102 (2020). 154. see sutton v. united air lines, inc., 527 u.s. 471 (1999). 155. ada amendments act of 2008, pub. l. no. 110-325, 122 stat. 3553; see also carly b. eisenberg, genetic predispositions v. present disabilities: why genetically predisposed asymptomatic individuals are not protected by the amended ada, 15 b.u. j. sci. & tech. l. 131, 149 (2010). 26 indiana health law review [vol. 18:1 discriminate based on it. legal recourse might lie in challenging the legitimacy of the employer’s receipt of the information, especially because employers are prohibited from requesting genetic information in most circumstances.156 however, unauthorized receipt of information may be difficult to prove. 3. insurance underwriting under the aca and the health insurance portability and accountability act the aca includes strong protections against the use of most health-related information in underwriting for individual health insurance. insurance companies may not even require customers to answer questions about health status, including preexisting conditions, on an application for coverage.157 this prohibition applies not only to genetic information but to all medical information. insurers may only ask applicants about their age, sex, geographic location, and use of tobacco.158 if an insurer were to gain information about an applicant’s genome, it could not use that information to deny a policy or to set the premium for it.159 a similar protection applies for group insurance under employer plans. the health insurance portability and accountability act (“hipaa”) prohibits underwriting of applicants who switch jobs and leave one employer risk group for another.160 the new insurer may not ask about health status or adjust coverage based on it, as long as the worker had enough continuous months of coverage with the prior employer. other provisions of hipaa regarding the privacy of medical information are discussed below. while the aca and hipaa provide important protections against discrimination based on genetic information in offering and pricing health insurance, this protection is limited to those two contexts; these laws do not ban the use of genetic information in other forms of insurance or in any other situation. 156. u.s. equal emp. opportunity comm’n, eeoc-nvta-0000-4, fact sheet: genetic information nondiscrimination act (2014) (“there are six very limited circumstances under which an employer may request, require, or purchase genetic information: where the information is acquired inadvertently, in other words, accidentally; as part of a health or genetic service, such as a wellness program, that is provided by the employer on a voluntary basis; in the form of family medical history to comply with the certification requirements of the family and medical leave act, state or local leave laws, or certain employer leave policies; from sources that are commercially and publicly available, including newspapers, books, magazines, and electronic sources (such as websites accessible to the public); as part of genetic monitoring that is either required by law or provided on a voluntary basis; and by employers who conduct dna testing for law enforcement purposes as a forensic lab or for human remains identification.”) 157. 42 u.s.c. § 300gg (2020). 158. 42 u.s.c. § 300gg(a)(1)(a)(iv) (2020) (stating that insurers are permitted to charge people who use tobacco products up to 50% more for coverage in individual and small-group policies). 159. see 42 u.s.c. § 300gg(a)(1) (2020). 160. 29 u.s.c. § 1181 (2020). 2021] am i my cousin’s keeper? 27 4. genetic property laws courts have generally refused to recognize that data subjects, whether patients or research participants, have an ownership right to their genetic information.161 however, a number of states have enacted statutes that grant them such a right.162 as of this writing, alaska, colorado, florida, georgia, and louisiana have passed such laws, and several other state legislatures have considered joining them.163 the laws grant individuals limited property interests in their own biological information. however, genetic property laws are not without risks of their own. requiring informed consent from everyone is no small challenge. if enough people decline to consent, the research databases may not be large or representative enough to be useful, and scientific advance will be unfortunately hampered. this “tragedy of the anti-commons” is a classic collective action problem.164 when the benefits of participating in research are diffuse and speculative, and the risks of datasharing can fall heavily on the individual, self-interest may lead these individuals to decline opportunities to participate in genetic research, to the detriment of medical progress and the population as a whole. conversely, stronger property rights, or other data privacy protections, might make people more comfortable participating in research, particularly if they stand to benefit financially, or in some other significant way, from sharing their data. researchers, in turn, might 161. among the most influential decisions are: moore v. regents of the university of california, discussed above; greenberg v. miami children’s hospital research institute, in which a federal district court rejected property claims by parents who had donated blood and tissue samples for development of a prenatal genetic test; and washington university v. catalona, in which the eighth circuit court of appeals found that research subjects had no property interest in tissue samples they had donated for research and, therefore, no say over whether the lead researcher could take them to another university. moore v. regents of the university of california, 51 cal.3d 120 (cal. 1990); greenberg v. miami children’s hospital research institute, 264 f. supp. 2d 1064 (s.d. fla. 2003); washington university v. catalona, 437 f. supp. 2d 985 (e.d. mo. 2006). 162. as an example of a case involving such a law, in 2013, alaska resident michael cole bought a dtc genetic test online from family tree dna. he swabbed his cheek, signed the release form, and sent in the sample. the company analyzed his dna and sent him a link with the results so he could research his ancestry. it also gave him the option to join online forums where he could meet consumers with similar ancestry. what it did not tell him—and the release form did not explain—was that it would expose his genetic information publicly on these forums. in alaska, that is illegal. under the state’s genetic privacy act of 2004, alaskans own both their dna samples and any test results based on them. no company can disclose a consumer’s genetic “property” without his or her informed consent. as of this writing, the case is still working its way through the courts. see michael cole v. gene by gene, ltd., no. 1:14-cv-00004-slg, 2019 wl 2571244 (d. alaska june 21, 2019). 163. progressive genetic ownership, supra note 108, at 1128. 164. the “tragedy of the anti-commons” occurs when one person can prevent others from using a common resource. it is the inverse of the more well-known “tragedy of the commons” by which everyone has an incentive to overuse a common resource. 28 indiana health law review [vol. 18:1 feel more willing to share their databases for collaboration if they do not have a profit incentive to withhold the data from their competitors. laws that recognize and protect property interests of data subjects who submit genetic samples are also of no benefit to relatives of those consumers who share their valuable genetic traits. they face a risk of identification and must contend with the porous protections provided by anti-discrimination laws. yet, they stand to derive no financial benefit from the sharing of information about their genes. b. access restrictions 1. hipaa the risk of unwanted disclosure and abuse of patient medical information was partially anticipated by hipaa, which restricts the use and disclosure of protected health information (“phi”), defined as “individually identifiable health information . . . that is: (i) transmitted by electronic media; (ii) maintained in electronic media; or (iii) transmitted or maintained in any other form or medium.”165 specifically, regulations implementing hipaa, known as the hipaa privacy rule, prohibit “covered entities”—health care providers, health care clearinghouses, and health plans—as well as their “business associates” from disclosing phi, unless it has been deidentified, except in certain defined circumstances.166 thanks to hipaa, genetic data collected in a clinical setting should be protected from most prying eyes if it contains personally identifiable information. this protection is far from complete, however. first, research has shown that deidentified genetic data can often be reidentified, exposing one’s personal health information to the outside world.167 second, hipaa contains numerous exceptions to the disclosure restrictions. these include disclosure without a patient’s consent (a) to other clinicians for treatment, (b) to insurance companies and other payers for payment, (c) for administrative activities, (d) to public health authorities, and (e) in response to a warrant or court order.168 data can also be disclosed in identifiable form for research purposes with the subject’s authorization, as discussed below.169 finally, patients have limited recourse to enforce hipaa and seek remedies. they can file a complaint with the office for civil rights of the dhhs, but they do not have a private right of action.170 165. 45 c.f.r. § 160.103 (2020). 166. 45 c.f.r. § 160.310 (2020). 167. katherine drabiak, caveat emptor: how the intersection of big data and consumer genomics exponentially increases informational privacy risks, 27 health matrix 143, 167 (2017). 168. 45 c.f.r. § 164.512 (2020). 169. 45 c.f.r. pt. 160 (2020). 170. leslie e. wolf et al., the web of legal protections for participants in genomic research, 29 health matrix 1, 16. 2021] am i my cousin’s keeper? 29 within the privacy rule is a set of standards specifically designed to protect electronically stored patient data, known as the security rule.171 under it, all covered entities must assess their security risks and put administrative, physical, and technological safeguards in place to mitigate them.172 while these measures enhance protection against hackers, they do not alter the rules that permit sharing of information that is lawfully obtained. under this regulatory scheme, the privacy rule bars access to genetic information under many circumstances. for example, a health care provider could not provide patient genetic data to a marketing firm without the patient’s consent. however, the protection applies only to data obtained in a health care context and affords several paths to circumvention. also, it does little for a patient’s relatives who may be identifiable in genetic data that are shared. beyond hipaa, few laws govern clinical genetic databases, and the ones that do are often conflicting. across the country, some states extend the meaning of covered entities to include employers, researchers, or other recipients of health information, but there is no uniform common practice.173 only the laboratories where the test results originate are governed by federal quality standards, set by the clinical laboratory improvement act (“clia”),174 but enforcement is uneven. while hipaa requires all laboratories to return test results to the patient, cms prohibits laboratories from doing so if they are not clia-certified. thus, hipaa’s insistence on transparency conflicts with clia’s caution regarding quality, leading the national academies of sciences, engineering, and medicine to call for new legislation to resolve this contradiction.175 perhaps most pertinent to genetic databases, hipaa was not designed to address the rights of genetic relatives whose health risks might also be implicated in a patient’s test results. as far back as 1988, the american society of human genetics advised that physicians should alert non-patients that they are at risk when “[t]he patient is unwilling to inform his or her at-risk family member(s), the at-risk family member(s) are easily identifiable, harm is likely to occur, and the condition is treatable or prevention measures and surveillance will reduce the risk.”176 ethicists continue to wrestle with this type of disclosure outside the immediate bounds of the physician-patient relationship, especially when the atrisk family member is a minor who cannot legally consent or “opt in” to receiving information about themselves. one must weigh the value of delaying until the child is old enough to decide against the “risk of adult-onset conditions” that require advance “life-planning.”177 to date, no consensus exists regarding this tradeoff. 171. 45 c.f.r. pt. 160 (2020). 172. 45 c.f.r. §§ 164.304, 164.310, 164.312 (2020). 173. wolf et al., supra note 170, at 54. 174. 42 u.s.c. § 263a (2020). 175. nat’l acads. of scis. eng’g & med. et al., supra note 22, at xxvii. 176. alicia latham schwark & michael f. walsh, duty to warn in the era of next generation sequencing, 18 am. j. bioethics 79, 79 (2018). 177. wolf, supra note 8, at 336. 30 indiana health law review [vol. 18:1 2. the common rule paramount among the protections for research data is the federal policy for the protection of human subjects, generally known as “the common rule.”178 the common rule is a regulation adopted by nineteen federal agencies that sponsor research involving human subjects to protect research participants.179 it was revised in 2018 to ease restrictions on the use of data obtained in the course of research.180 the rule and its limitations are discussed in more detail in section v below, where we present our proposal to build on its approach to provide wider privacy protection for all data subjects. since 1991, the office of human research protection (“ohrp”) of nih has administered the common rule to govern “all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the policy applicable to such research.”181 in all such research, the common rule requires researchers to obtain written consent from the potential subjects after providing them with a description of the risks and benefits of their involvement in the research. specifically, the researchers must communicate to the subjects “whether identifiers will be removed, whether biospecimens will be used for commercial purposes, whether the individual can expect to share in any profits, and whether clinically actionable results of genetic testing or genomic sequencing will be returned to the individual.”182 to enforce these protections, the rule requires that institutional review boards (“irbs”), committees located in each organization that receives federal research funding, oversee studies that use human subjects.183 risks to subjects can include the possibility of physical or psychological harm and also the possibility that the confidentiality of personal information will be compromised. to guard against such risks, irbs are charged with reviewing research protocols before they are implemented and reviewing research as it proceeds to enforce the protections that they mandate.184 178. the common rule grew out of the belmont report of 1978, written by the national commission for the protection of human subjects of biomedical and behavioral research, which was created pursuant to the national research act of 1974. see the nat’l comm’n for the prot. of human subjects of biomedical & behavioral research, the belmont report: ethical principles and guidelines for the protection of human subjects of research (1979), h t tps:/ /www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_final.pdf [https://perma.cc/8k2c-efx2]. the common rule and its major revision in 2018 are discussed later herein. see discussion infra section iv(b)(2). 179. the regulations of the department of health and human services are codified at 45 c.f.r. pt. 46 (2020). 180. see 45 c.f.r. § 46.101(l) (2020). 181. 45 c.f.r. § 46.101 (2020). 182. wolf et al., supra note 170, at 22. 183. § 46.101. 184. 45 c.f.r. § 46.109 (2020). 2021] am i my cousin’s keeper? 31 irb review applies only to research that is either federally funded or used in support of an application for approval of a new drug by the federal food and drug administration (“fda”).185 it does not apply to privately funded research or to data-sharing by commercial entities for other purposes, such as marketing. moreover, irbs focus their review on the protection of the research subjects themselves, so risks to relatives are rarely, if ever, considered. moreover, even the explicit protections that irbs enforce are not complete. first, written consent is not required for nonidentifiable information or deceased individuals. again, what the common rule envisioned as “nonidentifiable” in 1991 under then-current data technology may now be—or may soon become—identifiable in this era of “big data,” with greatly advanced technological progress and available access to many more sources of personal data, both health and non-health. second, there has been considerable debate over whether genetic biospecimens qualify as “human subjects.” in 2008, when researchers tried to publish an early study from one of these databases in plos genetics, the ohrp decided that genetic data did not fall into this category, exempting them from the common rule’s requirements.186 in 2012, the dhhs clarified this ruling with the interpretation that genetic biospecimens do qualify as “human subjects” if there is other personally identifiable information attached.187 finally, in 2018, the revised common rule officially concluded that deidentified biospecimens do not require consent, but the federal government is tasked with regularly reassessing what constitutes “identifiable personal information” and “identifiable biospecimen” in light of the ever-changing technological possibilities.188 even more troubling are the possibilities for use of subjects’ genetic data after the primary research has been completed. a particular concern for many subjects is that their data could be accessible to law enforcement. however, researchers may obtain a certificate of confidentiality from the nih to prevent the government from forcing them to disclose their data “in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding.”189 the nih believes certificates of confidentiality are necessary for “getting people comfortable” with sharing their personal information with the all of us program.190 historically, the dhhs secretary had broad discretion to issue certificates of confidentiality, but the 21st century cures act of 2017 made it mandatory for all federally funded research to obtain them.191 privately funded researchers have the option, but not the obligation, to apply for them under this 185. see § 46.101. 186. greg gibson & gregory p. copenhaver, consent and internet-enabled human genomics, 6 plos genetics art. e1000965 (2010), at 1. 187. koch & todd, supra note 53. 188. 45 c.f.r. § 46.102(e) (2020). 189. wolf et al., supra note 170, at 12 (footnote omitted) (quoting 42 u.s.c. § 241(d) (2016)); see discussion infra section v(b). 190. wolf et al., supra note 170, at 4. 191. id. at 20. 32 indiana health law review [vol. 18:1 law.192 even with a certificate of confidentiality, however, it is still possible for researchers to share genetic data after the study is completed. if they obtain “broad consent” from the subjects that does not specify a one-time use, then those data can be used for secondary research without specific consent for the later studies.193 even states that extend the common rule protections to non-federallyfunded research—california, maryland, new york, and virginia—allow secondary research without specific consent.194 whether subjects really understand this implication when they give broad consent—in other words, whether it is truly informed consent—is questionable. thus is born the possibility of limitless uses of the same data. 3. the european union general data protection regulation the european union (“eu”) moved ahead of the united states in aggressively protecting data on individuals in 2016, when it adopted the european union general data protection regulation (“gdpr”).195 that law grants data subjects rights to limit the storage and use of information concerning them that has been collected and stored electronically.196 it applies to all personal data, including genetic information in both anonymous and anonymized forms, and gives subjects the right to access their data, to have data transferred to a different entity, or to have them deleted.197 companies that store data must also implement reasonable measures to protect data from loss and exposure.198 they must notify government authorities within seventy-two hours and data subjects as soon as possible after learning of a breach and must perform regular data protection impact assessments and data protection compliance reviews to identify and address potential risks.199 the gdpr applies not only to companies based in the eu but also to any company that collects or processes personal data on eu citizens.200 this effectively extends its protections to virtually all data collection companies based in the united states. penalties for noncompliance can be severe, including fines 192. id. at 30 n.129. 193. mahsa shabani et al., from the principles of genomic data sharing to the practices of data access committees, 7 embo molecular med. 507, 508 (2015). 194. wolf et al., supra note 170, at 27. 195. see council directive 2016/679, 2016 o.j. (l 119) 7 (eu). 196. see id. 197. what is gdpr, the eu’s new data protection law?, gdpr.eu, https://gdpr.eu/what-isgdpr/ [https://perma.cc/e42z-f76k] (last visited nov. 13, 2020). 198. see id. 199. what does gdpr stand for? (and other simple questions answered), gdpr.eu, https://gdpr.eu/what-does-it-stand-for/ [https://perma.cc/ch45-2zcc] (last visited nov. 13, 2020); see also data protection impact assessment (dpia), gdpr.eu, https://gdpr.eu/data-protectionimpact-assessment-template/ [https://perma.cc/k9nk-ef75] (last visited nov. 13, 2020). 200. what is gdpr, the eu’s new data protection law?, supra note 197. 2021] am i my cousin’s keeper? 33 of up to 4% of a company’s annual revenue.201 a private right of action is available to subjects who believe their data are being misused or transferred for purposes they do not approve of.202 no current protection in american law is as strong. however, since it is based on foreign authority, the gdpr does not provide a remedy through american courts. despite the gdpr’s position as the world’s most aggressive effort to date to protect data stored and shared electronically, its protections have significant limits. subjects must affirmatively assert their rights, and it is not clear how many will take the time and effort to do so.203 polling shows that details of the law’s protections are still widely misunderstood.204 data subjects also may not realize how much data are maintained on them, the potential uses of those data, and the full extent of the risks that disclosure can present. furthermore, the gdpr offers no protection to relatives of data subjects. if a subject permits their data to be retained, the possibility always exists that a genetic relative of that subject, either a known or unknown relative, might be identified. 4. california consumer privacy act (“ccpa”) in addition to international and federal initiatives in the united states to protect personal privacy in the electronic age, protections have also been enacted by some states. in 2018, the california legislature enacted the california consumer privacy act (“ccpa”), which bolsters the rights of consumers whose data are collected by businesses.205 the first major legislation of its kind in the united states, the ccpa empowers individuals in the state to demand that companies disclose the personal data that have been collected on them and, if the individual wishes, to have those data deleted.206 the law’s reach extends beyond technology companies, such as facebook and google, to retailers, such as walmart and target.207 it went into effect january 1, 2020, and genetic data are one of the types of information covered.208 the ccpa was modeled on the gdpr, but it is considerably more limited in important respects.209 it protects only california residents and applies only to for-profit companies, so it offers no protection concerning data maintained by 201. id. 202. see everything you need to know about the “right to be forgotten,” gdpr.eu, https://gdpr.eu/right-to-be-forgotten/ [https://perma.cc/4qsb-lfj4]. 203. see id. 204. do consumers know their gdpr privacy rights?, gdpr.eu, https://gdpr.eu/ consumers-gdpr-data-privacy-rights/ [https://perma.cc/mhc7-f35m] (last visited oct. 25, 2020). 205. see cal. civ. code § 1798.150 (2020). 206. id.; see kari paul, california’s groundbreaking privacy law takes effect in january. what does it do?, guardian (dec. 30, 2019), https://www.theguardian.com/us-news/2019/dec/30/ california-consumer-privacy-act-what-does-it-do [https://perma.cc/4d54-qgwv]. 207. see paul, supra note 206. 208. id.; civ. code § 1798.150. 209. paul, supra note 206. 34 indiana health law review [vol. 18:1 nonprofit organizations and universities.210 companies are only required to provide the most recent twelve months of data in response to a request.211 moreover, they are exempt if they have complied with other applicable laws, such as hipaa.212 the ccpa’s penalties are meager, with a fine of only $7,500 for violations,213 and like the gdpr, the law offers no protection for relatives of data subjects whose genetic information may be identifiable in a database. 5. proprietary database terms of service with the exception of the gdpr and ccpa, proprietary genetic databases are largely exempt from the laws that limit access. for the most part, they follow the contract approach of other, non-genetic, for-profit companies. each company writes its own rules embodied in its “terms of service,” to which consumers must agree before they use the product. industry experts refer to arrangements as “clickwrap” when consumers are required to click on a specific part of a website signifying consent and as “browsewrap” when they implicitly consent just by using the website.214 the federal trade commission (“ftc”) typically upholds these agreements under their “notice and choice,” or “notice and consent,” framework.215 research has shown, however, that consumers rarely read what they are agreeing to, calling into question whether they really are given notice or choice—and certainly nothing rising to the level of informed consent generally required in health care.216 even if they did read the terms of service with care, consumers typically would not find all the facts they need to make a truly informed choice. a recent survey of ninety direct-to-consumer (“dtc”) genetic testing companies found that 39% did not have any privacy policy available on their website.217 of the policies that were accessible, the majority gave vague information about confidentiality and security.218 almost all reserved the right to modify their 210. rita heimes & sam pfeifle, new california privacy law to affect more than half a million us companies, iapp (july 2, 2018), https://iapp.org/news/a/new-california-privacy-law-toaffect-more-than-half-a-million-us-companies/ [https://perma.cc/3gzh-lb68]; see cal. civ. code § 1798.140 (2020). 211. see paul, supra note 206. 212. cal. civ. code § 1798.145 (2020). 213. cal. civ. code § 1798.155 (2020). 214. andelka m. phillips, reading the fine print when buying your genetic self online: direct-to-consumer genetic testing terms and conditions, 36 new genetics & soc’y 273, 278 (2017). 215. see, e.g., joel r. reidenberg et al., privacy harms and the effectiveness of the notice and choice framework, 11 i/s: j.l. & pol’y for info. soc’y 485 (2015). 216. see, e.g., jorge l. contreras, genetic property, 105 geo. l.j. 1, 6-7 (2016). 217. james w. hazel & christopher slobogin, who knows what, and when?: a survey of the privacy policies proffered by u.s. direct-to-consumer genetic testing companies, 28 cornell j.l. & pub. pol’y 35, 48 (2018). 218. id. 2021] am i my cousin’s keeper? 35 privacy policies after consumers had agreed to them, and very few companies promised to notify consumers when their policies had changed.219 only 49% of the policies gave consumers any information about what would happen to their physical sample after it had been processed.220 regarding the resulting genetic data, 45% of the policies said the company would keep the data forever, and 42% did not give any information about how long it would keep them.221 if consumers want to delete their genetic data in the future, 56% of the policies did not mention whether or how that could be done.222 over 70% did not give the consumer any information about the ownership, licensing, or commercialization of the data,223 and an astounding 95% said nothing about potential data breaches.224 if consumers want to ask questions about privacy issues, only 67% of the policies gave contact information, and “subsequent communication with customer service representatives revealed that, with the exception of industry leaders, these representatives were generally poorly equipped to handle privacy-related inquiries.”225 perhaps it is not surprising, therefore, that 43% of the research publications using these proprietary genetic databases did not specify any informed consent or disclosure procedure.226 quite often, the privacy policies are so vague as to disclose little meaningful information—if they even exist at all. in july 2018, the industry leaders—ancestrydna, 23andme, helix, myheritage, african ancestry, and familytreedna—agreed to voluntary guidelines to improve these policies,227 although the changes come with several caveats. the companies vowed to require consumers to give “separate express consent” to share genetic data with third parties,228 but the companies did not commit to report every instance of data-sharing. they volunteered to disclose the number of law enforcement requests they receive each year,229 not including any requests bound by a gag order. they will allow consumers to delete their data, but not if researchers are already using it. finally, they will attempt to ensure that customers submit their own data and not someone else’s.230 because the companies have announced these guidelines publicly, the ftc can penalize them for false or misleading advertising practices if they violate 219. id. at 49. 220. id. at 50. 221. id. at 51. 222. see id. 223. id. at 52. 224. id. at 53. 225. id. at 64-65. 226. spectator-bagdady et al., supra note 63. 227. see carson martinez, privacy best practices for consumer genetic testing services, fpf (july 31, 2018), https://fpf.org/2018/07/31/privacy-best-practices-for-consumer-genetic-testingservices/ [https://perma.cc/x8q7-6am6]. 228. romm & harwell, supra note 24. 229. id. 230. id. 36 indiana health law review [vol. 18:1 them.231 however, ftc enforcement has been spotty. to date, the agency has only taken action against dtc genetic testing companies twice.232 the majority of these policies, therefore, provide little, if any, privacy protection. moreover, in cases where protections do exist, it would be difficult for a data subject to know when a company had violated them or to enforce the terms if it did. relatives would not even know that a commercial database contained data that could identify them. one other federal regulator has intervened in this industry, but only with regard to a limited range of activities. the fda ordered 23andme to stop marketing the health benefits of its tests in 2013.233 however, two years later, the agency cleared the company to advertise its tests for “ancestry, wellness, traits, and carrier status for inherited disorders.”234 since then, it has approved 23andme’s carrier status test for bloom syndrome, genetic health risk (“ghr”) tests for ten diseases, and a test for three mutations in brca genes which predispose carriers to breast cancer.235 this approval comes with the ongoing requirement that the company demonstrate the analytical and clinical validity of the tests, as well as sufficient consumer understanding of their results.236 the fda has also exempted future ghr tests from premarket review.237 a few states supplement this regulation of health-related tests by requiring a physician’s order, but most states do not.238 c. remaining legal gaps this inconsistent and porous set of legal protections cries out for stronger measures. the need is made all the more urgent by the rapidly growing ability of data analysts to identify subjects in seemingly anonymous genetic databases.239 231. id. 232. jennifer k. wagner, ftc takes action to protect consumers from false genetic advertising claims, privacy rep. (july 3, 2014), https://theprivacyreport.com/2014/07/03/ftctakes-action-to-protect-consumers-from-false-genetic-advertising-claims/ [https://perma.cc/pt37q8rn]. 233. amanda holpuch, fda orders genetic company 23andme to cease marketing of screening service, guardian (nov. 25, 2013), https://www.theguardian.com/science/2013/nov/25/ genetics-23andme-fda-marketing-pgs-screening [https://perma.cc/p6s2-w5hx]. 234. abbasi, supra note 56. 235. direct-to-consumer tests, u.s. food & drug admin., https://www.fda.gov/medicaldevices/vitro-diagnostics/direct-consumer-tests [https://perma.cc/m7gm-frzj] (last updated dec. 20, 2019). 236. id. 237. id. 238. emily mullin, as consumer dna testing grows, two states resist, mit tech. rev. (sept. 28, 2017), https://www.technologyreview.com/s/608958/as-consumer-dna-testing-growstwo-states-resist/ [https://perma.cc/fxg9-fhza]. 239. erika check hayden, privacy protections: the genome hacker, 497 nature 172, 173 (2013). 2021] am i my cousin’s keeper? 37 moreover, there is little to protect relatives who did not submit genetic samples to a database and may not even know that they could be identified by samples that have been submitted to one. beyond the threats that remain for subjects, the presence of an inconsistent set of policies could compromise the ability of researchers and businesses that rely on commercial genetic databases to plan long-term compliance. were this uncertainty to lead them to avoid data-sharing arrangements or lead potential subjects to decline to submit genetic samples, the potential value of genomic data aggregation could be squandered. in the next section, we present our proposal for a regulatory mechanism to fill this gap. v. data protection review boards: proposed structure and function of all the legal gaps in genetic privacy protection, the most glaring is the lack of an external oversight mechanism for proprietary databases. to fill this void, we propose the creation of a universal system to oversee data-sharing by the companies that compile and maintain them. as discussed, it would take the form of a regulatory entity called a data protection review board (“dprb”) built upon the model of irbs. the irb model has already been applied to contexts beyond the protection of human subjects in government-sponsored research, such as requests by patients for compassionate-use access to experimental pharmaceuticals and requests by researchers for access to repositories of biospecimens, identifiable clinical trial data, and government-held demographic data. irb-like review has also been proposed as a mechanism for overseeing research access to electronic medical records maintained by health systems.240 while irbs have had their share of criticism, as we discuss below, they have served for nearly half a century as the principal device to safeguard research subjects’ interests and rights. thus, they are a good foundation to work from in fashioning protections for genetic data privacy. we do not propose that dprbs replace irbs, which would remain in place for federally funded research and clinical trials in support of fda new drug applications. rather, dprbs would fill the gap left by the common rule for proprietary database companies that fall outside its scope. the nature of dprb review would be narrower than that of irbs, which evaluate all potential risks to subjects. dprbs would focus on privacy risks and oversee all data-sharing arrangements that proprietary database companies engage in, including those for marketing or other business purposes. they would also bring to bear more specialized expertise in genomics and privacy than irbs may have. the scope of dprb review would be further limited to the sharing of data with other private entities. dprbs would oversee partnerships entered into as part of a proprietary database company’s business operations. disclosure to governmental authorities, including for law enforcement purposes, is usually 240. see, e.g., i. glenn cohen & michelle m. mello, big data, big tech, and protecting patient privacy, 322 jama 1141 (2019). 38 indiana health law review [vol. 18:1 nonconsensual and is subject to legal rules, such as constitutional limits on search and seizure;241 thus, it is beyond the scope of this article. our proposal further incorporates elements of another layer of protection that applies to requests for access to many biomedical databases, data access committees (“dacs”).242 these bodies exist to minimize threats to personal health information privacy by evaluating requests for access to all kinds of potentially identifiable biomedical information.243 as with our proposed dprbs, dacs apply specialized expertise in database management but they function only in the context of data access for research.244 for proprietary databases, their role would be subsumed by the new review mechanism, which would function in all contexts, not just research. as a foundation for the presentation of our dprb proposal, the following three sections examine the nature of the two existing mechanisms, irbs and dacs, on which our new review structure rests, and explain their limitations in the context of genetic databases. a. irbs: history and purpose irbs rest on an ethical foundation set forth by the code of helsinki published in 1964.245 this document emerged from the work of nations around the world to protect human subjects after revelations of the research abuses in nazi germany in which human subjects were used in gruesome and painful experiments, often with fatal consequences. the code of helsinki required that all research participation be voluntary as evidenced by the free consent of subjects who are fully informed of the risks.246 consequently, the primary focus of irbs is to assure that subjects receive full and comprehensible information prior to participation, that they freely consent to participation, and that they can withdraw their consent at any time.247 the concept of using irbs to enforce the principles of voluntary research participation based on full information grew out of proposals dating back to the mid 1960s.248 in 1953, the nih’s clinical center implemented a model of group peer review for studies involving healthy volunteers.249 in 1965, the director of 241. see, e.g., natalie ram, genetic privacy after carpenter, 105 va. l. rev. 1357, 1384-85 (2019). 242. mahsa shabani et al., genomic databases, access review, and data access committees, in med. & health genomics 29, 29-30 (2015) [hereinafter genomic databases]. 243. id. 244. see id. 245. see world med. ass’n, world medical association declaration of helsinki ethical principles for medical research involving human subjects, 310 jama 2191 (2013). 246. id. 247. see christine grady, institutional review boards: purpose and challenges, 148 chest j. 1148 (2015). 248. id. at 1150. 249. id. 2021] am i my cousin’s keeper? 39 that agency proposed that all research be evaluated by a panel of peers for ethical compliance.250 in 1966, the united states public health service applied the concept as a requirement for all federal health research, although it was not well enforced.251 the national research act, enacted in 1974,252 elevated the requirement for ethics review into a legislative mandate and applied the term “institutional review board” to the review mechanism.253 the law was a response to the latest in a string of scandals concerning abuses of human subjects. that scandal involved a research project known as the tuskegee study, which observed the natural course of syphilis in a group of poor african-american men from whom antibiotic treatment was withheld without their knowledge or consent.254 the law also established the national commission for the protection of human subjects of biomedical and behavioral research to study ways to reduce the risk of future abuses.255 its findings were published in 1979 as the belmont report.256 they were incorporated into regulations that today comprise the common rule.257 the fda issued its own regulations in 1981 for irb review of clinical research used to evaluate new drugs.258 unlike the common rule, these rules also apply to studies that are entirely funded by private companies.259 the rules prevent companies from using research findings to support an application to market a new drug unless the research has been subject to irb review.260 the common rule requires that irbs be registered with the ohrp, which monitors them for regulatory compliance.261 institutions that receive dhhs research funding, such as universities, hospitals, and research institutes, must provide assurance to the ohrp that they will comply with requirements for irb review.262 “the fda requires registration of irbs,” and evidence of irb review 250. id. 251. id. 252. national research act of 1974, pub. l. no. 93-348, 88 stat. 342. 253. robert i. field, health care regulation in america: complexity, confrontation, and compromise 216-17 (2007). 254. deneen l. brown, “you’ve got bad blood”: the horror of the tuskegee syphilis experiment, wash. post (may 16, 2017), https://www.washingtonpost.com/news/retropolis/ wp/2017/05/16/youve-got-bad-blood-the-horror-of-the-tuskegee-syphilis-experiment/ [https://perma.cc/75b9-5429]. 255. research implications, ctr. for disease control & prevention, https://www. cdc.gov/tuskegee/after.htm [https://perma.cc/5bwr-xmfn] (last updated mar. 2, 2020). 256. the nat’l comm’n for the prot. of human subjects of biomedical & behavioral research, supra note 178. 257. 45 c.f.r. pt. 46 (2020). 258. 21 c.f.r. pt. 56 (2020). 259. see 21 c.f.r. § 56.102 (2020). 260. 21 c.f.r. § 56.103 (2020). 261. grady, supra note 247, at 1150. 262. see id. 40 indiana health law review [vol. 18:1 must accompany submission of data to the agency for approval of new drugs.263 when the common rule and fda regulations were adopted, a large proportion of human subjects research involved clinical trials of new drugs, most of which were conducted at single sites.264 such studies lend themselves to a clear delineation of risks, since the conditions of testing are circumscribed and preclinical studies have typically been conducted to spot possible hazards. over the years since then, the nature of human subject studies has expanded markedly.265 most clinical trials now take place at multiple sites, some including as many as 100 or more, and the sites may be located in several countries.266 in such multi-site trials, each site is staffed by different personnel and draws from a different pool of patients.267 prior to revisions of the common rule in 2018, irbs at each site were required to review the research protocols, making the job of overseeing the overall study considerably more complex.268 clinical trials have also come to encompass different kinds of focus, often well beyond the effects of single pharmacologic interventions. studies may now examine a greater range of physiological and psychological phenomena and explore a wider array of outcomes. moreover, the indicators of interest may involve data from sources that are separate from the subjects themselves, such as tissue samples taken from them, social and behavioral observations of them, and their genetic profiles. in such studies, subjects might not even know that data about them were being used without an affirmative effort to inform them. with these developments, the range of ethical concerns related to research has grown as well. traditional clinical trials primarily raise issues related to whether subjects have been adequately informed of the risks of research and have consented to them voluntarily. newer studies raise additional concerns involving hazards such as conflicts-of-interest by investigators who stand to gain financially from the research, uncontrolled access to sensitive information by third parties, and the security of data after they have been collected.269 therefore, to protect subjects, irbs must consider a much broader range of threats. b. irbs and large database studies among the more difficult challenges that newer kinds of research pose for irbs is protecting subjects in studies that use large medical datasets. advances 263. id. 264. see id. 265. id. 266. id. 267. see id. 268. under the revised common rule, cooperative research studies must rely on approval of a single irb. 45 c.f.r. § 46.114 (2020). 269. see, e.g., moore v. regents of univ. of cal., 51 cal.3d 120, 174 (1990); see also sheryl gay stolberg, the biotech death of jesse gelsinger, n.y. times (nov. 28, 1999), https://www. n yt im es . com /1 9 9 9 /1 1 /2 8 /m agazine/the-biotech-death-of-je s se -ge ls in ger . h tml [https://perma.cc/3rvf-5fjc]. 2021] am i my cousin’s keeper? 41 in computing technology enable researchers to manipulate enormous amounts of information on millions of subjects. databases used in such research may include a wide range of indicators, including clinical test results, biometric features, performance on behavioral tests, and lifestyle factors, such as smoking and exercise. they may also include full or partial genetic profiles. although database studies do not pose direct threats of physical harm to subjects, they present substantial threats to privacy. unlike single-site clinical trials, data may be accessible to hundreds of research staff members at dozens of institutions who could leak information, either inadvertently or deliberately. they may also be vulnerable to hackers when they are not adequately protected. of particular concern, the threat of reputational, social, and economic harm may persist indefinitely if data are stored after a study has been concluded. the task facing irbs in protecting subjects from these harms requires an especially delicate balance. database studies cannot proceed without datasharing. in fact, the nih strongly encourages researchers to exchange data in studies that it sponsors. irbs that are overly aggressive in protecting subject privacy could constrain such sharing and impede important research.270 however, those that are too lenient risk permitting harm that might discourage people from participating as subjects in future studies. when data on patients are involved, the privacy rule provides that, in most cases, researchers may only access patient information that has been deidentified, under the assumption that this assures anonymity.271 however, some studies require data that are linked to individual patients. for example, genetic research that seeks to link gene variants to clinical outcomes may need to identify patients who have the variants of interest. in these instances, the privacy rule permits the release of identified information to researchers with irb review and approval.272 before permitting the research, an irb must seek to assure that risks to privacy are minimized by requiring that researchers implement various safeguards concerning data access and storage.273 for example, the amount of data collected must be the minimum needed for the research, anonymous identifiers must be used to link subjects to their data, and the identifiers and data must be deleted as soon as they are no longer needed.274 moreover, as discussed above, it is increasingly obvious that even with these protections much deidentified patient and subject data can be reidentified.275 270. see, e.g., amy a. lemke et al., broad data sharing in genetic research: views of institutional review board professionals, 33 irb 1 (2011). 271. office for civil rights, summary of the hipaa privacy rule, dep’t health & hum. serv., https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html [https:// perma.cc/cv6f-f3da] (last updated july 26, 2013). 272. office for civil rights, research, dep’t health & hum. serv., https://www.hhs.gov/ hipaa/for-professionals/special-topics/research/index.html [https://perma.cc/5842-aab7] (last updated june 13, 2018). 273. id. 274. see id. 275. see drabiak, supra note 167. 42 indiana health law review [vol. 18:1 use of patient information that may be identifiable in research may also be subject to a certificate of confidentiality, as discussed in section iv above.276 they are issued automatically for research that the nih funds and on request for other research. they permit use of potentially identifiable information, such as biospecimens and individual-level genomic data, but only subject to specified safeguards against unauthorized disclosure.277 however, there are exceptions to the safeguards when disclosure is required by federal, state, or local laws, is necessary for medical treatment, is authorized by an irb, or is consented to by the patient.278 studies have shown that the rigor of irb oversight of genetic database research varies considerably.279 for example, irb members differ widely in their characterization of the ethical implications of genetic data and of the risk of subjects being identified.280 this inconsistency suggests variability in the extent to which irb members understand the nature of genetic databases and the threats they can present to subject privacy.281 while such variability is not limited to comprehension of genetic information,282 the complexity of genetic research coupled with its relative novelty may exacerbate gaps among irb members in understanding this kind of information. the 2018 revision of the common rule streamlined the process of review of privacy risks when identifiable data are used by permitting investigators to obtain “broad consent” for twelve aspects of research, rather than separate consent for each one.283 among these aspects are the possible use of biospecimens for commercial profit that would not be shared with subjects, the possibility that subjects’ genomes may be sequenced, and the possibility that additional studies might be conducted with identifiable information about which subjects would not be informed. irbs are merely required to enforce this general disclosure and need 276. what is a certificate of confidentiality?, nat’l inst. health, https://grants.nih.gov/ policy/humansubjects/coc/what-is.htm [https://perma.cc/az4w-7sv5] (last updated jan. 15, 2019). 277. nih regulations also require investigators to ensure compliance by other investigators and institutions involved in the research that are not funded by nih as well as others involved in the study who have access to information subject to a certificate of confidentiality. they must also inform research subjects about the protections contained in a certificate of confidentiality as part of the informed consent process. 278. see id. 279. claire simpson et al., practical barriers and ethical challenges in genetic data sharing, 11 int’l j. envtl. res. & pub. health 8383, 8388 (2014). 280. amy a. lemke et al., attitudes toward genetic research review: results from a national survey of professionals involved in human subjects protection, 5 j. empirical res. on hum. res. ethics 83, 87-88 (2010). 281. see, e.g., robert klitzman, the myth of community differences as the cause of variations among irbs, 2 ajob primary res. 24 (2011). 282. christine grady, do irbs protect human research participants?, 304 jama 1122, 1122 (2010). 283. see federal policy for the protection of human subjects, 83 fed. reg. 28,497 (june 19, 2018). 2021] am i my cousin’s keeper? 43 not mandate that investigators implement specific protections for data once they have been collected.284 for example, while investigators must inform subjects how long their information will be stored, that period may be indefinite; and, while they must identify people whom subjects can contact for questions concerning storage and use of information, no specific actions are required to be taken in response.285 once broad consent has been obtained by a researcher, it can apply to use of a subject’s data for follow-up studies.286 the same consent can apply even if the 284. see elements of broad consent, vand. u. med. ctr., https://www.vumc.org/irb/ elements-broad-consent [https://perma.cc/4huw-l8ea] (last visited sept. 30, 2019) (“required elements of broad consent: 1. a description of any reasonabl[y] foreseeable risks or discomforts; 2. a description of any benefits to the participant or others that may reasonabl[y] be expected from the research; 3. a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; 4. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled; 5. if appropriate, a statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit; 6. if appropriate, for research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen); 7. a general description of the types of research with the identifiable private information or identifiable biospecimens. this description must include sufficient information such that a reasonable person would expect broad consent would permit the types of research conducted; 8. a description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens; 9. a description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which could be indefinite); 10. unless the participant or their lar [legally authorized representative] will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies; 11. unless it is known that clinically relevant research results, including individual results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant; and 12. an explanation of whom to contact for answers to pertinent questions about the storage and use of information and specimens, and to voice comments or concerns about participants’ rights, and whom to contact in the event of a research-related harm.”). 285. see id. 286. john w. maloy & pat f. bass iii, understanding broad consent, 20 ochsner j. 81, 82 (2020). 44 indiana health law review [vol. 18:1 subsequent research is still unspecified.287 in other words, subjects can be asked to consent to indefinite storage of their data for purposes that are not known at the time they consent. the investigator is not required to deidentify data that have been stored in identifiable form or to recontact subjects for new consents.288 the ongoing risks to privacy that might result are abundant. the 2018 revision further loosens restrictions regarding use of clinical data by dispensing with the requirement for irb review when hipaa applies.289 if an investigator has obtained consent for data disclosure under hipaa, further review by an irb is not needed.290 an exception also applies if the data have been deidentified according to hipaa regulations.291 there is a further exception for data that have been sent to a clinical repository for purposes other than research, such as for clinical improvement, if the repository is not supported by the nih or one of the other agencies to which the common rule applies.292 this exemption also applies if the data are released to a repository for research but the organization releasing them is not directly involved in research.293 most proprietary databases would fall within this category. in other words, they may share data with other private organizations without irb oversight. in sum, the revisions significantly lessen some privacy protections for genetic database studies. in particular, they assume that deidentification of data mitigates the risk of identifiability, an assumption that is clearly obsolete. moreover, even if a patient were willing to accept the risk of reidentification for themselves, risks remain for the privacy of relatives. c. data access committees a second line of defense for safeguarding subject privacy is data access committees (“dacs”).294 they may be housed centrally within a research organization, within a consortium of organizations, or in individual study sites.295 the nih maintains its own centralized dac system.296 access to the agency’s database of genotypes and phenotypes, which stores results of studies it has 287. see id. 288. see elements of broad consent, supra note 284. 289. see 45 c.f.r. § 46.104(d)(4)(iii) (2020); see also how the common rule 2018 updates can affect your research and quality improvement strategies, prometheus res., https://www.prometheusresearch.com/common-rule-updates-2018/ [https://perma.cc/ylz8-lw82] (last visited nov. 14, 2020). 290. see how the common rule 2018 updates can affect your research and quality improvement strategies, supra note 289. 291. see id. 292. see id. 293. id. 294. genomic databases, supra note 242. 295. see shabani et al., supra note 193, at 507. 296. id. 2021] am i my cousin’s keeper? 45 sponsored, is overseen by sixteen dacs that review requests for consistency with data use limitations.297 dac oversight may involve various aspects of data-sharing arrangements.298 these include the content of arrangements with outside researchers, the qualifications of those researchers, and the disposition of data after the conclusion of a study.299 dacs are often in a better position than irbs to assure privacy protection because their focus is narrowly directed to data access, as is the expertise of their members. however, dac review is not subject to the same rules that govern irbs, and the use of dacs is voluntary.300 moreover, dac review is often decentralized, with multiple dacs overseeing different sites involved in the same study.301 this risks inconsistency in oversight.302 for example, a centralized european database, the european genome-phenome archive (“ega”), relies on hundreds of local dacs, with consequent inconsistency as well as lack of transparency.303 information on the operations of smaller dacs overseeing access to the ega is especially difficult to obtain.304 several international organizations have issued guidance on harmonizing dac policies. one is the biobanking and biomolecular resources research infrastructure, based in austria, which offers a self-assessment tool for quality control of biobanking practices.305 the public population project in genomics and society, a consortium of biobanks based in montreal, has published best practices for biobanking, including practices to protect patient privacy.306 the global alliance for genomics and health, based in toronto, has published a framework for the responsible sharing of genetic data.307 however, none of these guidance documents includes a mechanism to enforce compliance. moreover, despite the proliferation of dacs and attempts to coordinate their role, there is no consistency in their relationships with irbs or institutional ethics 297. see id.; see also genomic databases, supra note 242, at 31-32. 298. it has been proposed that data access committees form the basis for privacy protection for research databases. see phaik yeong cheah & jan piasecki, data access committees, 21 bmc med. ethics art. 12 (2020). 299. see genomic databases, supra note 242, at 31. 300. see shabani et al., supra note 193, at 508. 301. see id. at 507. 302. genomic databases, supra note 242, at 33. 303. see shabani et al., supra note 193, at 507. 304. see ega eur. genome-phenome archive, https://ega-archive.org/ [https://perma. cc/p6ng-lfhd] (last visited nov 17, 2019). 305. bbmri-eric launches self-assessment survey for biobanks and sample collections, bbmri-eric, http://www.bbmri-eric.eu/news-events/bbmri-eric-launches-self-assessment-surveyfor-biobanks-and-sample-collections/ [https://perma.cc/l25n-xl9d] (last visited sept. 20, 2019). 306. see int’l soc’y for biological & envtl. repositories, 2012 best practices for repositories collection, storage, retrieval, and distribution of biological materials for research, 10 biopreservation & biobanking 79 (2012). 307. see bartha maria knoppers, framework for responsible sharing of genomic and healthrelated data, 8 hugo j. art. 3 (2014). 46 indiana health law review [vol. 18:1 committees, nor are they subject to formal regulatory requirements similar to those for irbs.308 as a result, their actual functioning with regard to ethical concerns varies considerably. some avoid performing independent ethics reviews altogether, some review ethics documents from the organization hosting the research, and some evaluate ethical issues on their own. this is a particular concern for studies that involve research collaborators scattered across different countries and data that are accessible globally. d. data protection review boards: concept and operations with these numerous limitations, the protection of research subjects’ genetic data by irbs and dacs is incomplete and inconsistent, especially with regard to data that are collected and held by proprietary databases. these companies can voluntarily constitute their own review bodies, but because they are not mandated to do so by law, there is no external oversight of the rigor of such reviews.309 at the same time, their growing databases represent an increasingly valuable resource for research. to fill this regulatory void, dprbs would review all data access to commercial genetic databases by external organizations, other than law enforcement, for any purpose, whether research, drug development, or marketing. their oversight would include reviewing and approving data-sharing arrangements, imposing and enforcing conditions to safeguard subjects’ privacy, and performing ongoing monitoring of the arrangements to enforce those conditions. the concept is to build on the irb model to create a level of review that is decentralized and flexible, yet strong enough to effectively protect the interests of research subjects. located within each organization that hosts research, irbs can consider the environment within which individual studies are conducted. they can adjust their oversight accordingly. if their conditions are not met, they can withhold permission for a study to commence or withdraw permission once it has started. dprbs would similarly oversee data-sharing at the level of each database company. they would consider the individual needs and circumstances of the company and the nature of its database. they would impose conditions, as described below, and data-sharing could not commence or could be halted in the absence of compliance. external government oversight by the ftc or a new federal agency would enforce dprb mandates in a manner similar to that of irb enforcement by federal research funding agencies and the fda. however, we propose one significant organizational difference from irbs. rather than requiring a standing dprb for all companies, they would be constituted for each data-sharing arrangement. some companies may not have 308. shabani et al., supra note 193, at 508-09. 309. see also research ethics & policy, 23andme, https://research.23andme.com/research/ #ethics [https://perma.cc/334r-epdb] (last visited sept. 20, 2020) (discussing how 23andme is exemplary in this regard because it uses an independent external accredited irb for its research). 2021] am i my cousin’s keeper? 47 enough data-sharing arrangements to justify a standing review body. constituting separate dprbs also reduces the risk of capture by the host organization, which has been a criticism of irbs. the following is a description of key structural and operational aspects of dprbs. we acknowledge that modifications may be needed in practice. our intent is to present a template on which details of a regimen of review can be built. 1. dprb functions as with irb oversight, dprb review would consider the nature of each datasharing arrangement so that conditions on sharing and methods of monitoring compliance could be tailored to the specific risks involved. in contrast to irbs, which focus almost entirely on protecting the subjects themselves, the dprb’s purview would extend to risks to relatives of subjects who might be identifiable. in other words, while the substantive focus of dprbs would be narrower, the scope of protection would be broader in their consideration of risks to a wider range of people. enforcement of the mandate for dprb oversight would reside at the federal level. the ftc is an obvious candidate for such duty. it has a broad mandate to protect consumers in a range of circumstances under its authority to regulate “unfair or deceptive acts or practices in or affecting interstate commerce.”310 the agency has already begun using that authority to investigate privacy risks in online data-sharing and the practices of companies that receive, store, and share data on individuals. with regard to genetic information, it has issued advice to companies that sell genetic test kits as to types of practices that might be considered unfair or deceptive.311 however, while the ftc has legal authority and expertise in this area, enforcement to date has been minimal, with only one enforcement action as of 2019, involving a company that made unsupported health claims about its tests and failed to follow its own stated data privacy policy.312 effective ftc oversight of dprbs would require explicit authority and direction from congress. the agency would also likely need additional funding for this new responsibility. as the extent of genetic database sharing grows, enforcement responsibility might be transferred to a newly created agency with explicit jurisdiction over genetic research. the creation of such an agency has already been proposed in the form of a digital privacy agency.313 if such an 310. 15 u.s.c. § 45(a)(1) (2020). 311. elisa jillson, selling genetic testing kits? read on., fed. trade commission (mar. 21, 2019), https://www.ftc.gov/news-events/blogs/business-blog/2019/03/selling-genetic-testingkits-read [https://perma.cc/uy6s-zgch]. 312. ellen wright clayton et al., the law of genetic privacy: applications, implications, and limitations, 6 j.l. & biosciences 1, 19 (2019). 313. kate cox, new bill would create digital privacy agency to enforce privacy rights, ars technica (nov. 5, 2019), https://arstechnica.com/tech-policy/2019/11/new-bill-would-create48 indiana health law review [vol. 18:1 agency were to be created, dprb oversight and enforcement could be included in its scope of authority. federal authority to regulate genetic database privacy is clearly granted by the constitution’s commerce clause, which gives congress the power to regulate economic activity that takes place across state lines.314 genetic database sharing is a quintessentially national and even international endeavor. we recognize that enacting the necessary legislation would require political consensus that may be difficult to achieve. however, as the extent of genetic data collection and dissemination grows, so will threats to privacy. public unease over privacy intrusions could increase and lead to pressure for government protection that might alter the political dynamics.315 2. dprb structure ideally, dprbs would operate independently of the organizations that maintain the databases that are subject to review. irbs are constituted and operated by the organizations they oversee, and their membership often includes colleagues of the investigators whose research proposals they review. this has led to criticism that irb oversight can tend towards leniency.316 concern about overly lenient oversight might be greater for review bodies housed within commercial organizations that operate on a profit-making basis. arguably, the profit motive poses an especially significant corrupting influence. as an alternative organizational structure, dprbs could be housed in independent nonprofit organizations. they would convene review boards in response to requests from database companies and charge a fee to cover costs. there is precedent for the use of external review organizations in irbs that are operated by for-profit corporations. these entities conduct reviews for organizations that lack the resources to conduct them on their own.317 however, while their reviews have been defended as rigorous,318 for-profit review organizations may be susceptible to conflict-of-interest concerns in the profitmaking pressure they face to approve studies in order to encourage repeat business. for this reason, we favor the use of nonprofit organizations, for which digital-privacy-agency-to-enforce-privacy-rights/ [https://perma.cc/8g5n-8p7q]. 314. u.s. const., art. i, § 8, cl. 3. 315. sharon begley, consumers aren’t wild about genetic testing – nor are doctors, stat (feb. 12, 2016), https://www.statnews.com/2016/02/12/consumers-arent-wild-genetic-testingdoctors/ [https://perma.cc/a379-w2wb]. 316. danah boyd et al., supporting ethical data research: an exploratory study of emerging issues in big data and technical research (aug. 4, 2016) (unpublished manuscript) (on file at https://datasociety.net/library/supporting-ethical-data-research-an-exploratory-study-of-emergingissues-in-big-data-and-technical-research/). 317. see wcg irb, https://www.wcgirb.com [https://perma.cc/bxp5-b28x] (last visited nov. 22, 2020). 318. see ezekiel j. emanuel et al., should society allow research ethics boards to be run as for-profit enterprises?, 3 plos med. art. e309 (2006). 2021] am i my cousin’s keeper? 49 the potential conflict is at least somewhat mitigated. as an alternative to external operation of dprbs, strict federal oversight of internal company dprbs could ameliorate some of the risks of over-leniency. such oversight could be centralized within whichever agency oversees dprb operations. when research is involved, additional enforcement authority could reside in the agency that oversees the kind of research involved. for example, the fda could reject noncompliant genetic database research in support of new drug applications. similarly, the nih could condition its research funding on dprb compliance if an entity relies on data from a commercial database. whether housed internally or externally, accreditation of dprbs by an external body could add an additional layer of assurance. such a process already exists for irbs through the association for the accreditation of human research protection programs (“aahrpp”), which accredits irbs that meet standards for membership, expertise, adequacy of procedures, and other factors.319 although accreditation is not required for irbs by federal regulations, it signifies compliance with national standards and enhances the credibility of irbs that achieve it and of the institutions for which they conduct reviews. it has been found to improve the performance of irbs, in part because of the training requirements it mandates for irb members.320 the membership of dprbs would be prescribed through regulations in a similar manner to that of irbs. fda regulations, for example, require that irbs overseeing clinical trials have at least five members. at least one member must have primary concerns in the scientific area involved in the study under review, one must have primary concerns that are not scientific, and one must be unaffiliated with the institution conducting the research and not be an immediate family member of someone who is.321 the irb must also strive for demographic diversity and include members who are capable of reviewing the specific area of research involved, who are familiar with applicable law, and who understand standards of professional conduct and practice. regulations governing irbs issued by the nih and other federal funding agencies are less specific concerning composition, requiring only that both scientific and nonscientific perspectives be represented.322 regulations for dprb membership should prescribe that it includes experts in genetics, cybersecurity, data analytics, privacy, bioethics, and relevant aspects of law. in addition to representing the range of relevant expertise, they would reflect the range of relevant interests related to genetic data-sharing. these 319. see aahrpp, http://www.aahrpp.org/ [https://perma.cc/x9kq-8byp] (last visited sep 25, 2019). 320. see abhidnya vasant desai et al., role of accreditation in quality improvement of institutional review board, 8 persp. clinical res. 145 (2017). 321. 21 c.f.r. § 56.107 (2020). 322. the sec’y’s advisory comm. on human research prots., attachment b: recommendation on irb membership and definition of non-scientist under 45 cfr 46 and 21 cfr 56, hhs.gov, https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2011-january24-letter-attachment-b/index.html [https://perma.cc/t8n5-tw3y] (last updated jan. 24, 2011). 50 indiana health law review [vol. 18:1 include subjects whose information is contained in a genetic database, biomedical researchers who analyze genetic databases, and companies that use the information. an ideal size for dprbs would likely be between ten and fifteen members, although the number might be adjusted based on experience. the average irb size is 13.9 members.323 however, the size might vary with the size of the workload. to ensure that they have appropriate expertise, individuals who wish to serve on a review board could apply to the agency for certification of eligibility, subject to verification of their credentials. database companies needing the services of a dprb could select review board members from among those who have received certification. this procedure goes beyond the requirements for irb membership, but the review of genetic disclosure risks requires more specialized expertise. 3. resources for operations clearly, organizing and operating dprbs requires resources. they present a significant administrative burden and need a commitment of time from experts, whether they are employees of database companies or outsiders. these resources are supplied to irbs and dacs by the organizations involved. however, the cost of administering dprb review could create a disincentive to data-sharing by smaller commercial organizations, thereby discouraging valuable initiatives. a solution would be for dprbs to be supported by the federal agency that oversees their operation. the agency could provide compensation to the members and cover operational expenses, such as travel and meeting costs. a user fee paid by the organization operating the dprb could help to defray the cost in a similar manner to the user fees paid by pharmaceutical companies for fda review of new drug applications.324 however, unlike fda user fees, dprb fees could be adjusted to the size and resources of the organization involved. 4. the nature of dprb reviews the scope of dprb reviews would be limited to privacy risks. consideration of other kinds of research risks would be left to irbs when applicable research is involved. for example, a study in support of a new drug application to the fda or one that is funded by a federal agency that involved both data-sharing and an invasive medical procedure would be subject to both forms of review. given current technologies for reidentification of genetic data, no set of safeguards can assure anonymity of database subjects. however, a number of measures can significantly mitigate privacy risks, and dprbs could mandate the use of some or all of such measures. deidentification of data, although only a 323. joseph a. catania et al., survey of u.s. human research protection organizations: workload and membership, 3 j. empirical res. on hum. res. ethics 57, 64 (2008). 324. see 21 u.s.c. § 379h (2020). 2021] am i my cousin’s keeper? 51 minimally effective step, would be a start. other solutions could include safeguards that the privacy rule directs irbs to consider for research with identified patient information.325 the objective and guiding principle would be that the arrangement for the sharing and use of data must present no more than “minimal risk” to subjects’ personal health information and genetic privacy.326 among the most important safeguards applicable to dprb oversight would be an adequate plan to protect identifiable information from improper use and disclosure, an adequate plan to destroy information that could link data to subjects’ identities as soon as possible after the data-sharing arrangement has been concluded, and adequate written assurances that data will not be reused or disclosed to others except as required by law or as necessary for research oversight. additional requirements could be added to respond to the distinctive risks of genetic data disclosure, including threats to the privacy of subjects’ genetic relatives.327 these could include: 1. further sharing of data with third parties beyond the arrangement under review would require additional dprb approval. 2. all data that are shared must be encrypted. 3. any electronic transmission must be through secure servers. 4. individuals who have access to data must be vetted for trustworthiness and technical competence. 5. records must be kept of individuals who have accessed data. those records must be retained for a specified minimum amount of time after an arrangement has ended, perhaps seven years, which is the current standard for patient medical records. 6. records must be available for review by the dprb and representatives of the federal agency overseeing its operations. 7. data that are shared would be limited to those that are needed for the arrangement, and entire genomes would only be shared when necessary. in addition, dprbs could mandate the use of various technical measures that have been developed to reduce the risk of data identifiability. some of them are complex and require substantial technical expertise to implement, so dprbs 325. what is a certificate of confidentiality?, supra note 276. 326. in a technological environment that is as fast-changing and evolving as that in which genetic analysis is now being coupled with widespread data-sharing, it is neither wise nor possible to articulate a precise standard. the regulatory entities must be given a reasonable latitude of discretion to tailor the regulatory regime to the rapidly changing realities of internet communication and the evolving nature of multi-party cooperation in genetic research. 327. how can covered entities use and disclose protected health information for research and comply with the privacy rule?, nat’l inst. health, https://privacyruleandresearch. nih.gov/pr_08.asp [https://perma.cc/6d7z-ahlb] (last updated feb. 2, 2007). 52 indiana health law review [vol. 18:1 would have to include appropriately trained experts.328 after determining the applicable safeguards, dprbs would oversee datasharing arrangements as they progress to monitor adherence. as part of the monitoring, the database company involved would submit regular reports to certify compliance. at the end of the arrangement, the company would certify that all data have been deleted or destroyed by the partner organization. the stringency of dprb-mandated protections might vary according to the intended use of the data. data-sharing for marketing or similar business activities that only benefit private parties have the least public value, and the most rigorous safeguards would apply. privacy protections for arrangements that facilitate biomedical research with the potential to help large numbers of people would be weighed against societal value. the mission of dprbs in both cases would be to consider the appropriate balance. 5. enforcement irb review is largely self-enforcing. studies that receive federal support lose that support if it is not properly implemented.329 if a federal agency has withdrawn support from an institution’s research for noncompliance, it may deny funding to that institution for future research. studies of new drugs that lack irb review may not be used in support of new drug applications to the fda. we propose a two-prong approach to enforcement of dprb review. the first would empower the agency administering the dprb program to impose fines on organizations that fail to comply with review requirements. the second would impose liability under consumer protection laws for violations. this would subject violators to additional enforcement authorities and associated penalties. for data-sharing arrangements that lead to publishable research, peerreviewed journals could adopt dprb review as a standard for publication, as many do for irb review.330 the international committee of medical journal editors is considering a standard that would require sharing of clinical trial data 328. there are several technical measures that can increase the difficulty of identifying individuals whose information is contained in a large database. see yaniv erlich & arvind narayanan, routes for breaching and protecting genetic privacy, 15 nature rev. genetics 409 (2014). these measures include: (1) removing metadata and other identifiers that may accompany genetic data; (2) keeping data in a secure location and limiting access to those with a demonstrated need to access it under the data-sharing arrangement and who have been vetted for reliability; (3) denying users direct access to data and permitting only queries to the database; (4) using a trusted agent or third party to manage any interactions between subjects and data users; (5) using a data anonymizing methodology known as “k-anonymity”; (6) differential privacy; (7) data encryption; (8) secure multiparty computation; and (9) one-way encryption. id. some of these measures might also be mandated by a dprb for a specific data-sharing arrangement. 329. 45 cfr § 46.122 (2020). 330. see robert j. amdur & chuck biddle, institutional review board approval and publication of human research results, 277 jama 909 (1997). 2021] am i my cousin’s keeper? 53 before the results could be published.331 such a standard could be extended to require that when genetic data are shared, dprb review must be applied. 6. limitations we acknowledge that our proposal has limitations. as with irbs, dprbs add time and administrative complexity to the process of exchanging data. if dprbs are not adequately resourced, delays could become unmanageable. the burden of complying with this added layer of bureaucracy could thereby impede valuable biomedical research and other socially beneficial activities. however, all regulatory schemes add cost and complexity. this is inherent in the nature of inserting third-party oversight into a commercial activity, but it is not reason to avoid reasonable regulatory measures. when a risk is substantial, the cost of inaction can be greater than the burden of added bureaucracy. we believe that implementation of a system of dprbs represents a reasonable compromise between direct centralized regulation that could stifle much valuable medical innovation and a laissez faire approach that leaves data subjects and their relatives at risk. irbs, on which our proposal is modelled, represent a similar compromise that has achieved a sustainable balance for almost half a century. d. alternative approaches we see our proposal as the most effective of several remedies that have been enacted or proposed to address electronic data privacy. alternative schemes do not go as far in addressing individual instances of data-sharing, and most do not address the unique risks of collecting and storing genetic information. moreover, none address the interests of subjects’ relatives. an alternative to a unified nationwide program might be found in state-bystate legislation along the lines of the ccpa.332 as with other areas of regulation, such a federalist approach could be more responsive to local values and attitudes than federal legislation.333 however, state regulation of data-sharing for databases that contain information on millions of subjects would be difficult to enforce. companies respond to directives by the eu and large states such as california because of the large markets they represent. smaller states would have considerably less influence. state regulation could also present jurisdictional conflicts and gaps, as restrictions on use of a subject’s data in one jurisdiction may provide little protection to a relative who lives in another. finally, state 331. darren b. taichman et al., data sharing statements for clinical trials – a requirement of the international committee of medical journal editors, 376 new eng. j. med. 2277, 2277 (2017). 332. see discussion supra section iv(b)(4). 333. new state ice co. v. liebmann, 285 u.s. 262, 311 (1932) (“it is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.”). 54 indiana health law review [vol. 18:1 regulation is problematic in cases where data are shared among entities in different states, which is increasingly the norm. moreover, state-by-state legislation would pose significant logistical difficulties for compliance. one survey of existing state and federal genetic privacy laws found considerable variability in their nature and scope.334 it also found them to be limited in their application, focusing primarily on data-sharing for research and clinical care, rather than on information that is voluntarily submitted to private companies for ancestry tracing or other purposes. were a patchwork of more stringent state laws to emerge that apply to all data-sharing, compliance could become impractical, thereby creating a barrier to innovation. the government accountability office has proposed the enactment of new federal legislation expanding the ftc’s enforcement authority over data privacy.335 some commentators have proposed creation of a new federal agency to regulate sharing of online personal data. stronger centralized oversight along these lines might be more efficient than adding a system of decentralized review boards, such as dprbs, and might be less susceptible to capture by data companies and their business partners. however, any gains in efficiency would be lost in flexibility. centralized regulation would operate at a distance from the parties that are subject to its oversight and is therefore likely to be less responsive to their needs and circumstances. a large new federal bureaucracy might also act slowly, introducing delays that could impede some valuable data-sharing arrangements. vi. conclusion almost 2,500 years ago, hippocrates advised physicians to promise to protect, “[w]hat [they] may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad.”336 that advice is at least as relevant today as it was centuries ago. just as physicians must be privy to confidential information to effectively treat individual patients, genetic databases must contain sensitive personal information to facilitate activities such as biomedical research that can be used to treat many. trust in medical professionals has always been crucial to the medical enterprise. today, that trust must extend to those who administer technologies that advance medical care. we believe that a system of oversight of genetic database sharing in the form of dprbs strikes a reasonable balance to facilitate genetic research while protecting individuals, both those who submit data and those whose identities can 334. wolf et al., supra note 170, at 61-62. 335. see generally internet privacy: additional federal authority could enhance consumer protection and provide flexibility, u.s. gov’t. accountability off. (jan. 2019), https://www. gao.gov/assets/700/696437.pdf [https://perma.cc/36zz-9dbq]. 336. john c. moskop et al., from hippocrates to hipaa: privacy and confidentiality in emergency medicine—part i: conceptual, moral, and legal foundations, 45 annals emergency med. 53, 53 (2005). https://perma.cc/36zz-9dbq 2021] am i my cousin’s keeper? 55 be revealed through the data of relatives. on the one hand, research with large databases is essential to the advance of biomedical science. it lies at frontiers of innovation in areas such as gene therapy, precision medicine, and artificial intelligence. on the other hand, without privacy safeguards, individuals may hesitate to submit data that are subject to sharing. such reluctance risks killing the goose that is giving us golden eggs of knowledge, not to mention creating the risk of widespread harm to individuals. third-party expert oversight and guidance regarding the sharing of genetic data is an important and necessary step toward balancing those concerns. irb oversight has been effective in reducing, albeit not eliminating, risks in human subjects research. that model has the advantages of flexibility to accommodate different circumstances and of bringing different expert perspectives to bear. we can take that model one step further to the next frontier in biomedical research to build the trust that genetic database investigations require. we have no time to lose. whether through dprbs or some other mechanism, it is imperative to act quickly before more data on individuals are released without any way to retrieve them. moreover, the anonymity of genetic data will only become more tenuous over time. if privacy concerns discourage potential subjects from contributing genetic samples, it will not be responsible regulation that impedes innovation but rather the lack of it. revising assisted outpatient treatment statutes in indiana: providing mental iiealm treatment for those in need katherine b. cook • i. introduction ............................................................................... 662 a. the issue .................................................................................. 663 b. roadmap .................................................................................. 665 ii. why aot statutes are necessary ......................................... 666 a. who is ajj'ected? ...................................................................... 666 b. why severely mentally ill individuals are more susceptible to being incapable of understanding that they need treatment; lack of insight ......................................................................... 666 c. reports show that medication or other treatment can help668 1. the revolving door of severely mentally rl individuals. 668 a. violence ...................................................................... 669 b. homelessness .............................................................. 671 c. recidivism and other problems in jails or prisons and in hospitalization .................. , .................. · ........................ 671 (i) jails are inappropriate for seriously mentally ill individuals ............................................................ 672 (ii) prison is not the right place for many seriously mentally ill individuals ......................................... 673 3. higher costs for inmates in jails and prisons .............. : ... 675 d. evolution from civil commitment statutes .............................. 676 e. who these civil commitment statutes fail to protect ............ 616 iii. model statutesikendra•s law ...................... u-...................... 677 a. kendra 'slaw: the most prominent aot statute .................... 677 1. weaknesses of the statute .................................................. 679 b. other aot statutes .................................................................. 680 c. results of aot statutes/studies ............................................... 681 d. argument against aot statutes: constitutionality .................. 683 n. indiana's aot statute .............................................................. 684 a. indiana statute ......................................................................... 684 b. weaknesses of indiana's statute .............................................. 684 1. dangerous or gravely disabled ....................................... 685 2. no standard of proof ........................................................ 685 3. lack of 3rd party petition ability ..................................... 686 4. no mandated time commitment ....................................... 686 5. no definitions for the terms ............................................. 686 • j.d., 2012, indiana university robert h. mckinney school of law; b.a., 2003, university of wisconsin-madison. 662 indiana health law review (vol. 9:2 6. no guarantees of outpatient program placement ........... 687 c. results of indiana's statutes .................................................... 687 v. revised aot statute proposal for indiana ......................... 688 a; kendra's law with modifications ............................................ 688 vi. funding ........................... -.............................................................. 690 a. benefits of aot: reduction in hospital costs ........................ 691 b. funding through medicaid or taxes ...................................... 691 vii. conclusion .................................................................................. 692 i. introduction "tragedies make headlines. too often, these tragedies involve victims or perpetrators with severe mental illness and could have been prevented if only there had been timely treatment."1 on january 8, 2011, six people werekilled, and twelve more were seriously injured, including gravely wounded former congresswoman gabrielle giffords, when anarmed as­ sailant open-fired on a crowd gathered for a political rally at a supermarket parking lot in arizona? two medical experts concluded that jared lough­ ner, the alleged shooter in the case, suffers from schizophrenia, disordered thinking, and delusions, including delusional ideas regarding rep. giffords. he is currently adjudged unfit for trial and is undergoing forced medication and mental health treatment at a federal prison hospital in missouri. 3 be­ fore the shooting, loughner exhibited signs that he had a serious mental illness, yet these signs were not taken seriously.4 it is possible that mental health treatment may have prevented this horrific event that ruined not only the lives of the victims and their families, but also loughner's life.5 signs of mental instability-were observed before the shootings. firs~ in october 2007, loughner was cited for possession of drug paraphernalia. although the charge was later dismissed, loughner was required to com1. mental illness in 2010: top under-reported stories, treatment advocacy ctr., http:/ /www.treatmentadvocacycenter.org/index.php?option=com_ content&task=view &id=17ll&itemid=247 (last visited mar. 26, 2012). • 2. e. fuller torrey, a predictable tragedy in arizona, we emptied state mental hospitals starting in the 1960s without providing adequate treatment alternatives, wall st. j. (jan. 12, 2011), http://online.wsj.com/arti.cle!sb100014240527487037797045760739 73345594508.html. 3. id; joseph schuman, jared lee loughner trial: judge grants doctors more time to restore accused's mental fitness, huffington post, feb. 6, 2012, http://www. huffingtonpost.com/2012/02/06/jared-lee-loughner-trial-mentalcompetency _n _1258397 .html. 4. torrey, supra note 2 ("the fact that he was barred from his college until he was evaluated by a psychiatrist would appear to confirm the nature of the probleni."). 5. see generally jared loughner had 5 run-ins with college police, cbsnews.com (jan. 10, 2011, 4:42 pm), http://www.cbsnews.com/stories/2011/01/10/nationallmain72 31560.shtml. 6. /d. 2012] revising assisted outpatient treatment statutes in indiana 663 plete a pretrial diversion program. 7 also, on october 4, 2011, loughner was suspended from pima community college and that same week with­ drew from the college. 8 on october 7, 2011, loughner received a letter from the college informing him that in order to be readmitted he would have to provide the college with a letter from a mental health official indi­ cating "his presence at the college does not present a danger to himself or others."9 thus, prior to the shooting, loughner was already in the criminal justice system and was showing obvious symptoms of a serious mental ill­ ness. the glarinff problem is that arizona's public mental-health services are inadequate.1 per capita, arizona offers less community health services and maintains less psychiatric beds than forty-eight states; however other states, such as indiana, are not much better equipped with those services.11 "if you don't have hospital beds and ou~atient clinics to treat mentally ill people, those people don't get treated." 2 the tragedy caused by jared loughner was just waiting to hap~.13 while arizona has less psychiatric bed and community treatment availability than most states, at present, no state in the nation has enough beds for its mentally ill population.14 the current tragedy happened in arizona, but the same situation could have eas­ ily occurred in any other state.15 "the killing of six people in tucson is one more sad episode in an ongoing series of tragedies that should not be hap­ pening."16 the solution is clear-ensure, through outpatient treatment, that people.who have a severe mental illness receive the care they need.17 a. thelssue "a 2008 study out of the university of pennsylvania that examined murders committed in indiana between 1990 and 2002 found that approxi­ mately 10% of the murders. were committed by individuals with serious 7. /d. 8. /d., 9. /d. 10. torrey, supra note 2. 11. /d. 12. id. 13. id 14. id 15. id 16. id 17. /d. ("based on arizona's 2010 pfjpulation and on estimates by the national insti­ tute of mental health of the number of individuals with untreated schizophrenia at any given time, there are today in arizona over 21,000 individuals with untreated schizophrenia. most of them. thankfully, are not violent. but a small number of them-about 10% according to my meta-analysis of relevant studies-do become violent, usually because of their delusional thoughts and what their voices (auditory hallucinations) are telling them. this situation holds in every state. it is thus not a question of if such tragedies will occur but rather when and how often.''). 664 indiana health law review [vol. 9:2 mental illnesses."18 "at least 400/o of the 3.5 million americans diagnosed with either schizophrenia or manic-depression" (both severe mental illness­ es) "lack insight into their disorder; and they do not reco~ze that the symptoms of their mental illnesses are, in fact, symptoms."19 they are "unaware that they are ill" and do not, or cannot, seek the treatment they 20 need. · · one key to correct this startling situation is assisted outpatient treat­ ment ("aot"): aot is court-ordered treatment (including medica­ tion) for individuals who have a history of medication noncompliance, as a condition of remaining in the community. studies and data from states using aot prove that it is effective in reducing the incidence and duration of hospitalization, homelessness, arrests and incarcerations, victimization, and violent episodes. aot also increases treatment compliance and pro­ motes long-term voluntary compliance, while reduc• • ,,21 mg caregtver stress. aot statutes have been enacted in many states, and have proven help­ ful not only for individuals but for society as a whole, by reducing recidi­ vism~ homelessness, and violence; and by improving overall quality of life.2 while the debate over whether these statutes are constitutional per­ sists, states have upheld the statutes against due process· challenges.2 it also appears that the supreme court would apply an intermediate scrutiny standard, if not simoly rational basis, and uphold these statutes as a legiti­ mate state interest. 24 indiana has a series of statutes giving the court authority to order as18. id. 19. kathleen winchell, the need to close kentucky's revolving door: proposal for a movement towards a socially responsible approach to treatment and commitment of the mentally ill, 29 n. ky. l. rev. 189, 189 (2002). 20. see william spaulding, applications of therapeutic jurisprudence in rehabilita­ tion for people with severe and disabling mental illness, 17 t.m. cooleyl. rev. 135, 135 (2000). . 21. assisted outpatient treatment laws, treatment advocacy ctr., http://www. treatmentadvocacycenter.orglindex.php?option=com _ content&task.=view&id=39&itemid=68 (last visited mar. 26, 2012). 22. see new york state assisted outpatient treatment program evaluation, n.y. state office of mental health (june 30, 2009), http://www.omh.ny.gov/omhweb /resources/publications/aot_program _evaluation!. 23. in re k.l., 806 n.e.2d 480, 485-86 (n.y. 2004); see also riggins v. nevada, 504 u.s. 127, 136 (1992). 24. in re k.l., 806 n.e.:id at 485; see washington v. harper, 494 u.s. 210, 222-23, 229 (1990) (prison); mills v. rogers, 457 u.s. 291, 299 (1982) (hospitalization). '2012] revising assisted outpatient treatment statutes in indiana 665 sisted outpatient treatment,. but they are lumped in with the inpatient com­ mitment statutes and do not differentiate between the two types of treatment or give different elements to satisfy each.25 the current legislation is inef­ fective and rarely used by courts for the purpose it was created?6 while there is a statute allowing for aot on a voluntary basis, known as the psy­ chiatric assertive identification and referral (pair) program, it is volun­ tary and only helps a comparatively small percentage of people: those who choose to go through the program instead of jail. 27 the pair program does not address other individuals with serious mental illnesses who also need treatment, such as the homeless; those who are recently released from pris­ on; and those who do not belong in jail but would not voluntarily choose to go through pair. 28 an amendment to the statute is in order so as to im­ prove the lives not only of the individuals, but of others in the community and society as a whole. b. roadmap section ii of this note will discuss why aot statutes are necessary. it will give a brief background of the persons that aot statutes affect, as well as the types of mental illnesses that are specifically addressed. section ii will· also examine the reasoning behind the necessity of aot statutes and whether medication or other treatment has been proven to be helpful in cer­ tain types of behaviors. section iii will discuss statutes in other states that have proven to be effective, as well as their weaknesses. in section iii, several well-known case studies will also be analyzed to measure aot ef­ fectiveness. section iv discusses the current state of indiana's aot law and its weaknesses. section v proposes a new indiana statute that more specifically defines assisted outpatient treatment rules and implementation in indiana and briefly touches on the constitutionality of aot statutes. fi­ nally, section vi lays out possible funding options. 25. see ind. code§§ 12-26-14-1 to -5 (2010). 26. abby flynn & rosanna esposito, indiana needs to use assisted outpatient treatment (aot) and stop criminalizing mental lllness, in michael w. kempf, mental illness and the criminal justice system jn indiana 17 (2008), available at http://www.nami.org/content/microsites 169/nami_indiana/home 156/resources87/kempf _report_6_13_2008.pdf. 27. george f. parker, m.d., dir. offorensic psychiatry, ind. univ. sch. ofmed., lec­ ture at ind. univ. robert h. mckinney sch. of law: mental illness and the criminal justice sys. {feb. 24, 2011). 28. judge barbara a collins, mental health ct., lecture at ind. univ. robert h. mckinney sch. oflaw: mental illness and the criminal justice sys. (feb. 24, 2011). 666 indiana health law review ·[vol. 9:2 ii. why aotsta1utesarenecessary a. who is affected? this article will address aot statutes that only affect the severely mentally ill with psychotic symptoms. in some states, aot statutes are used on a variety of mentally ill individuals, including those who do not fall into the severe category.29 many mental health groups use the phrase "se­ vere and persistent mental illness" to identify individuals who suffer from a dsmn axis i disorder.30 axis i disorders include schizophrenia, schizoaffective disorder, bipolar disorder, and major depression.31 axis i psychotic disorders like schizophrenia include three types of symptoms: (i) positive symptoms, which distort reality for the individual and include hal­ lucinations, delusions, and paranoia; (2) negative symptoms, which often lead to a decline in emotional functioning, such as sadness; and (3) cogni­ tive symptoms, which may affect memory and attention. 32 the posi­ tive/psychotic symptoms (i.e., hallucinations and delusions) are a primary source of problems associated with homelessness, violence, and arrests and are most commonly found in people with the axis i disorder of schizophre­ nia. 33 research suggests that persons with schizophrenia, for example, are "meaningfully it~aired in real-world tasks that involve shifting attention in cluttered scenes." 4 thus, they are less likely to be able to function in the same way that many others do. b. why severely mentally ill individuals are. more susceptible to being incapable of understanding that they need treatment; lack of insight ·another symptom of psychotic illnesses is lack of insight. between 29. see rachel a. scherer, note, toward a twenty-first century civil commitment statute: a legal, medical, and policy analysis of preventive outpatient treatment, 4 ind. healtiil. rev. 361,369-70 (2007). 30. id. at 371-72. 31. george f. parker, m.d., dir. of forensic psychiatry, ind. univ. sch. ofmed., lec­ ture at ind. univ. robert h. mckinney sch. of law: introduction to severe mental lllness (jan. 20, 2011); see also am. psychiatric ass'n, quick reference to 1he diagnostic criteria from dsm-iv-tr, at xi, 37-38 (2000) (describing inherent limitations to diagnos­ tic categorizations, explaining the multiaxial system). 32. l.m. camargo et al., disrupted in schizophrenia 1 interactome: evidence for the close connectivity of risk genes and a potential synaptic basis for schizophrenia, 12 molecular psychiatry 74, 74 (2007); scherer, supra note 29, at 372. 33. paul s. appelbaum et al., violence and delusions: data from the macarthur vio­ lence risk assessment study, 157 am. j. psychiatry 566 (2000); see also scherer, supra note 29, at 416-17. 34. rebecca l. fuller et al., impaired control of visual attention in schizophrenia, 115 j. abnormal psychol. 266, 273 (2006); see also e. fuller torrey, surviving schizophrenia: a manual for famiues, consumers, and providers 35 (5th ed. 2006) (1983). 2012) revising assisted outpatient trea'iment statutes in indiana 667 forty and sixty percent of those diagnosed with schizophrenia and manic­ depressive illness may be truly unaware that they are ill and thus find no reason to take treatment.35 this lack of insight into one's own illness is a biological symptom known as anosognosia.3 this symptom is especially difficult to overcome when untreated because the more someone, even a trusted loved one, tries to convince the mentally ill individual that he/she is suffering from a hallucination or delusion, the more the individual may be­ lieve the hallucination or delusion to be true, and the loved one to be ly­ ing.37 ultimately, such individuals may sink further into their illness, as their belief in the reality of their symptoms is unshakeable. someone suf­ fering from such a symptom is likely to reason, ''why should i take medica­ tion ifthere is nothing wrong with me?"38 distorted reality may also influence whether mentally ill individuals continue with treatment. half of all schizophrenics stop using their medica­ tions within one year of befinning treatment. 39 one common reason for this is adverse side effects, 4 but these are becoming less and less of an is­ sue with advancements in medicine.41 another reason is because of the distorted reality. "[a] '[schizophrenic's] distorted view of reality [may] not allow [him or her] to recognize [his or her] illness,' and as such, [he or she] terminate[s] the medication.'.42 the nature of a schizophrenic person's de­ lusions make him prone to "abandon the [highly effective] medications that may quell the angry, suspicious voices in [his] head[].'.43 if patients do not believe they are mentally ill and in need of medication, or if they do not believe medication will help them, they will not follow through with com­ munity treatment when left unmonitored.44 35. e. fuller torrey & mary t. zdanowicz, introduction in l'rea1ment advocacy clr., model law for assisted l'rea1ment (2000), available at http://www.treatment advoca­ cycenter.org!genera1resources/index.php?option=com_content&task=view&id=49&itemid =78; xavier f. amador et al., awareness of illness in schizophrenia and schizoa.ffective and mood disorders, 51 arcidves gen. psychiatry 826, 828-29 (1994) ('"finding that nearly sixty percent of patients with schizophrenia had moderate to severe unawareness of having a mental disorder"'). 36. torrey & zdanowicz, supra note 35. 37. parker, supra note 31. 38. torrey & zdanowicz, supra note 35. 39. elana h. margolis, the failure of civil confinement: how russell e. weston jr. slipped through the cracks and the potential for many more to follow, 26 new eng. j. crim. & civ. confinement 129, 133 (2000). 40. see theodore vanputten, why do schizophrenic patients refuse to take their drugs?, 31 arcidvesofgen. psychiatry 67, 70 (1974). 41. torrey & zdanowicz, supra note 35. 42. see margolis, supra note 39, at 133 (quoting schizophrenics often quit taking medicine, news & rec. (greensboro, n.c.), july 28, 1998, at a4). 43. id. (internal quotation marks omitted). 44. see id. 668 indiana health law review [vol. 9:2 c. reports show that medication or other treatment can help treatment is essential to help control symptoms of mental illness, es­ peci~ if found early on, such as when the first hospitalizations or arrests occur. 5 medication, while the most effective treatment for schizophrenia, is not the only treatment that is often used. 46 psychotherapy, cognitive be­ havioral therapy, housing assistance, vocational rehabilitation, and other community services are good supplements to enhance the medication's ef­ fects and to help the individual achieve a higher recovery level. 47 "further, most of the antipsychotic medications used to treat schizophrenia only help to treat the positive symptoms and so medication should be supplemented with other forms of treatment to help cope with the negative and cognitive symptoms of the disease!.48 1. the revolving door of severely mentally ill individuals non-adherence to medication leads to what is known as the ''revolving door.',49 this phenomenon describes the process by which an individual with a severe mental illness commits a crime (or becomes hospitalized), and for a variety of reasons is released back onto the streets without support or supervision and then commits another crime. 50 the individual may have been released because she was found incompetent to stand trial but did not fit the high standards for inpatient civil commitment, or she may have been released from the hospital after she was stabilized on her medications, but she stopped taking them upon her release.51 this is extremely common, and some individuals with severe mental illnesses are arrested multiple times per year.52 without a mechanism that ensures individuals are com­ pliant with their medications once they are released, the cycle will continue. compared to other states, indiana has more laws that address this "re­ volving door" issue, but only after the individual with the serious mental 45. nat'l alliance on mental illness ind., pubijc poijcy platform 1, available at http://www.nami.org/content!microsites169/nami_indiana/home156/advocacy21/ platform%20finalo/o20joes.pdf ("early identification and treatment accelerates recovery and protects the brain from further harm related to the course of the illness . . . . most people with serious mental illness need medication to help control symptoms."). 46. see id ("most people with serious mental illness ... also rely on supportive coun­ seling, self-help groups, assistance with housing, vocational rehabilitation, income assistance, and other community services."). · 47. scherer, supra note 29, at 379-80. 48. id. at 379-80. 49. see generally winchell, supra note 19. 50. collins, supra note 28. 51. see winchell, supra note 19, at 190. 52. id. (chronicling the legal and mental health history of patricia ann smith, a thirty­ eight-year-old louisville woman, who had been diagnosed with schizophrenia, and who has been arrested at least sixty times in the past seven years (citing kim wessel, arrests of men­ tallyri woman continue, courierj., june22, 2001, at ai)). 2012] revising assisted outpatient treatment statutes in indiana 669 illness is identified by police. ·if he or she meets certain criteria, the mental­ ly ill offender may elect to participate in the p a1r program. 53 in this pro­ gram, a mentally ill offender completes an assigned· outpatient treatment program in lieu of going to jail. 54 he must plead guilty to participate in the program, and after one year's successful completion, his charge will be dismissed. 55 while this program is an essential tool in diverting seriously mentally ill individuals from getting stuck in the revolving door, it only focuses on a sub-section of the population who could greatly benefit from aot. specif­ ically, it fails to include those who elect not to participate in the program, often as a result of the symptoms of their mental illness, and on people who desperately need treatment but have not been arrested additionally, aot statutes should include those mentally ill individuals who have been recent­ ly released from jail or prison and are in need of aot to re-integrate them into society or to help them continue with their medication without a lapse in treatment. therefore, mandatory aot statutes for certain qualified indi­ viduals would complement and extend the results achieved ·through the p a1r program by including these additional populations within their scope. a .. violence one reason supporting the need for mandatory aot statutes is the violence associated with the psychotic symptoms of certain severe mental· illness, which is exacerbated by non-adherence to medication. some stud­ ies have shown that an increased level of psychotic symptoms may be the best predictor of the likelihood of committing a violent act.56 other studies· suggest that another important predictor of future violence among the se­ verely mentally ill is non-adherence to medication. 57 this non-adherence to medication is brought on, in part, by great difficulty in being able to meet the inpatient civil commitment standards (where a patient is forced to com­ ply with medication regimes), and even if they originally meet these strict standards, by what typically happens after a patient is released from the hospital (where compliance is no longer required). ''people with paranoid and psychotic symptoms, which can become worse if medications are dis­ continued, may[] be at higher risk for violent behavior."58 dr. torrey es­ timates there to be "approximately 1000 homicides a year" committed by· 53. collins, supra note 28. 54. ld. 55. jd. 56. e. fuller torrey, out of the shadows: confronting america's mental illness crisis 46 (1997). 57. ld. 58. schizophrenia and poverty, crime and violence, schizophrenia.com, http://www.schizophrenia.com/poverty.htm#society(last visited apr. 11, 2012). 670 indiana health law review [vol. 9:2 people suffering from schizophrenia and bipolar disorder, "almost all of whom were not taking medication at the time of the homicide. "59 in 1992, sociologist henry steadman studied individuals discharged from psychiatric hospitals and found that of those stopping their medica­ tion, "27 percent of ... patients report at least one vi9lent act within a mean of four months after discharge."60 another study found that patients with a severe mental illness were twice as likely to commit an act of violence be­ fore hospitalization, when they were not on any medication, as compared to post-hospitalization, when they were taking medication.61 further, though less than 1% of the total population compromise people with untreated se­ vere mental illness, they are responsible for nearly 1000 homicides annually in the united states, or approximately 4 to 5% of all murders. 62 . . notably, other "research suggests that those with serious mental ill­ nesses are no more dangerous than the general public when. they take.their prescribed medications.':.63 without any system of mandatory treatment in place, there are no assurances that individuals will remain compliant with their medication regimen upon release from jail or hospitalization.64 [i]f the public ever becomes fully aware of how often mentally ill individuals with a history of violent be­ havior are released from jails and hospitals with no mandatory continuing treatment, there will be a mass outcry directed toward the lawyers, judges and psy­ chiatrists who are responsible for this state of af­ s:. • 65 1arrs. however, this outcry can easily be assuaged. research suggests that patients who have a propensity for violence but are given mandatory aot are "four times less likely ... to perpetrate serious violence after undergo59. /d. 60. winchell, supra note 19, at 210 (quoting e. fuller torrey & robert j. kaplan, a natio.nal survey of the use of outpatient commitment, 46 psychiatric services 778, 778 (1995)); see also ken kress, an argument for assisted outpatient treatment for persons with mental illness illustrated with reference to a proposed statute for iowa, 85 iowa l. rev. 1269, 1341-42 (2000). 61. winchell, supra note 19, at210-11. 62. !d. at 211. 63. christian e. piccolo, note, falling through the cracks: the need for enhanced supervision in the involuntary outpatient civil commitment setting, 54 vn..l. l. rev. 309, 318-19 (2009). 64. fuller torrey, nowhere to go: 1he tragic odyssey of the homeless mentally ill 16 (1988). 65. bruce g. link & ann stueve, psychotic symptoms and the violent behavior of mental patients compared to community controls, in john monahan & henry j. steadman, violence and mental disorder: developments in risk assessment 139 (1994). 2012] revisingassistedoutpatienttreatmentstatutesinindiana 671 ing ·treatment. ,,66 b. homelessness another reason in support of mandatory aot statutes is the impact of homelessness on individuals with severe mental illness. "at any· given time, there are more people with untreated severe psychiatric illnesses liv­ ing on america's streets than are· receiving care in hospitals.',67 approxi­ mately one-third of the homeless population68 is suffering from schizophrenia or· bipolar disorder; 69 "people with serious mental illnesses have greater difficulty escaping homelessness than other people; many have been living on the streets for years."70 the majority of these mentally ill homeless individuals who are left on the streets without treatment "regular­ ly forage through 'garba'e cans and dumpsters" for any stilall amount of food in order to survive. 1 additionally, at least one-third of the homeless· women who are mentally ill have been sexually assaulted, many on multi;. pie occasions. 72 while many of these individuals would like to get off the street and undergo treatment, their mental illnesses blocks them from mak­ ing that decision for themselves. 73 when patients fail to seek treatment, the symptoms of their mental illnesses can easily take over. c. recidivism and otherproblems in jails or prisons and in hospitali­ zation the first reason that jails and prisons are not appropriate for the men­ tally ill is that jails and prisons are not structurally equipped to meet the needs of individuals with a serious mental illness.74 secondly, the staff 66. press release, columbia university, outpatient care for individuals with severe mental lllnesses reduces crime, say researchers (feb. 18, 2010), http://www.treatment advocacycenter.org/index.pbp?option=corn_content&task=view&id=l511&itemid=247. 67. scmzophrenja,com, supra note 58. 68. id. 69. id. (indicating approximately one third of the homeless population is mentally ill). 70. human rl:glits ·watch, ill-equippeid: u.s. prisons and offenders with mental illness 21 (2003), available at http://www.brw.org/sites/default/files/i'eports/ usal003.pdf. 71. treatment advocacy ctr., homblessness: one of tile consequences of failing to treat individuals wfl1l severe psychiatric disorders 4, available at www.treatmentadvocaeycenter.org/storageldocumentslhomelessness--apr _ 09.pdf; parker, supra note 27. 72. torrey & zdanowicz, supra note 35. 73. schizophrenia and homelessness: our demand for efficiency will turn the hard· est hit into outcasts, prelapse mag., sept. 1995, available at http://www.mental health.com/magllpre-homl.html. 74. schizophrenia and poverty, crime and violence, schizophrenia.com, http://www.schizophrenia.com/poverty.htm#society (last visited apr. 11, 2012). 672 indiana health law review [vol. 9:2 working at the facilities are not trained to act as psychiatric caretakers?5 not surprisingly, incarcerating such large numbers of seriously mentally ill people creates additional problems.76 one such problem is the lack of psy­ chiatric care subsequent to release from jail or prison because the correc­ tions systems are separate from the mental 'health system. 77 consequently, recidivism is higher among seriously mentally ill individuals than it is for others who are released. 78 in los angeles, ninety percent of the mentally ill inmates in the jail have been arrested at least once before?9 "houston's harris county jail in 2008 included two mentally ill individuals who had been booked thirty times since 1999 and forty-five times since 200l.',so in indianapolis, one seriously mentally ill homeless individual has been arrest­ ed eighty-three times in the course of three years, for small misdemeanors associated with living on streets.81 two other individuals have been arrest­ ed thirty-four times each over the course of just one year. 82 moreover, "[p]ersons with mental illness who have prior criminal rec­ ords or histories of violence have a particularly difficult time getting access to treatment; many mental health programs simply will not take them.',s3 thus, a system of guaranteed treatment through aot will be able to pro­ vide them with the medical attention they need. (i) jails are inappropriate for seriously mentally ill individuals mentally ill individuals who commit a crime for reasons unrelated to the symptoms of their mental illness should be held accountable for the crime, like anyone else in society.84 however, seriously mentally ill people should neither be arrested nor imprisoned solely because they lack treat­ ment or access to appropriate care, nor should they be incarcerated any longer than others would be simply because they are mentally ill.85 be­ tween 2004 and 2005, there were over ''three times more seriously mentally 75. e. fuller torrey bt al., more mentally ill persons are in jails and prisons than hospitals: a survey of the states 8-9 (2010), available at http://www.treatmentadvocacycenter.org/storageldocuments/finaljails_ v_hospitals_study.p d(, at8-9. 76. jd. 77. jd. 78. jd 79. id 80. torrey bt al., supra note 75, at 8-9. 81. robert hipple, indianapolis police sergeant, lecture at indiana univ. robert h. mckinney sch. of law: mental illness and the criminal justice system (feb. 24, 2011) (on file with author). 82. id 83. human rights watch, supra note 70, at 30. 84. mark r. munetz & patricia a. griffin, use of the sequential intercept model as an approach to decriminalization of people with serious mental illness, 51 psychiatric sbrvs. 544, 544 (2006). 85. /d. 2012] revising assisted outpatient treatment statutes in indiana 673 ill individuals in jails and prisons than in hospitals" .in the united states.86 in 1991, the national alliance for the mentally ill (nami), an advocacy group for the families of those with mental illnesses, surveyed 1401 mem­ bers and found that 40% of the family members with serious mental illness­ es of those in the group bad been in jail at some point in their lives. 87 "the vast majority of people with schizophrenia who are in jail have been charged with misdemeanors such as trespassing. as many as one in five (20o/~ of the 2.1 million americans in jail and prison are seriously mentally ill. "8 this includes inmates with schizophrenia, manic depression (bipolar disorder) and major depression.89 many people suffering from schizophrenia are stuck in the revolving door between hospitals, jails and sbelters.90 thirty percent of those dis­ charged from illinois psychiatric hospitals return to the hospital within thir­ ty days of their discbarge.91 the percentage of re-bospitalizations substantially increases as time passes, with as much as a s~ percent re­ hospitalization rate within a year of discharge in new york. 92 suicide is another major problem in jails for the mentally i11.93 "sui­ cide is the leading cause of death in jails and 95% of those who commit suicide in jails have psychiatric illnesses.'84 there have been many studies showing that nearly half of all inmate suicides are committed by those who are mentally ill.95 one washington study found that seventy-seven percent of those who attempted to commit suicide were mentally ill, as compared to fifteen percent among inmates in the general jail population. 96 (ii) prison is not the right place for many seriously mentally ill individuals unfortunately, in indiana, the number of mentally ill being sent to prisons that are unable to provide the necessary treatment continues to in­ crease.97 such confinement in the prison system, particularly within the 86. torrey et al., supra note 75, at 1. 87. ld. at9. 88. schizophrenia.com, supra note 74 (citing human rlghrs watch, supra note 70, at25). 89. ld. 90. ld. 91. id. 92. id 93. torreyet al.,supranote 75, at9-ll. 94. torrey & zdanowicz, supra note 35. 95. torreyet al.,supranote15, at9-ll. 96. id 97. human rights watch, cold storage: super-maximum security confinement in indiana 11 (1997), available at http://www.hrw.org/legacy/reports/1997/ usind/. · 674 indiana health law review [vol. 9:2 higher security facilities, is reprehensible.98 people with mental illness have a very difficult time following the rules that govern society, and this difficulty is especially magnified in prison settings because prison rules are very restrictive. 99 the consequences of not following prison rules cause intense stress. 100 many mentally ill prisoners are remanded to higher secu­ rity facilities, even super-maximum security facilities, often due to the dis­ ciplinary records they have accumulated from beinf disruptive or not precisely following the rules· due to lack of treatment 10 in a recent interview at the new castle correctional facility, an indi­ ana maximum-security prison, an inmate confided that he had been incar­ cerated for stealing a radio approximately twenty-six years ago.102 he has schizophrenia, is not receiving the proper medication through the prison system, and has been continually detained because of his inability to control his psychotic symptoms.103 his psychotic episodes have included throwing excrement or committing other minor infractions.104 these rule infractions have resulted in his receiving an ever-increasing sentence, and the date of ·his release still unk:nown.105 without proper treatment, his rule infractions could keep him incarcerated indefinitely, which is not an uncomnion story. before the super-maximum security unit (shu) in the wabash valley correctional facility was shut down for being inhumane because of its cruel and unusual punishments toward mentally· ilu'risoners, ·over half of the in­ mates sent to the facility were mentally ill.1 they were often sent there for numerous rule infractions in their former prisons.107 for these inmates, this real-life. horror and unending cycle of ''the social isolation and restrict­ ed activities aggravate their illness and immeasurably increase their pain and suffering. in a tragic vicious cycle, their worsened mental condition leads to more rule infractions, such as self-mutilation, for which they re­ ceive the additional punishment of even more time in segregation."108 ·warehousing psychotic and severely ill people without access to ap­ propriate treatment to curb their symptoms is a cruelty which no one de­ serves.109 in some cases, it might even be considered torture.u0 in 1997, edgar hughes, an inmate in the supermax housing unit at wabash valley 98. id 99. id 100. id 101. id 102. interview with anonymous source, mental health unit at the new castle correctional facility (feb. 3, 2011). 103. id 104. id 105. id 106. human righi's watch, supra note 97, at 11. 107. /d 108. /d. 109. /d 110. id. at 11-12. 2012] revising assisted outpatient treatment statutes in indiana 675 correctional facility, ended his confinement in tragedy. 111 he was actively psychotici extremely depressed, paranoid, and feeling persecuted by the guards.11 he began ''bombing" the guards with excrement and subse­ quently, one momin/i~ he suffered a ''mysterious head trauma," causing se­ rious brain damage. 3 based on the facts available, human rights watch concluded that "hughes was the victim of one of two situations: either he suffered severe physical abuse at the hands of correctional officers, or he underwent a severe psychiatric breakdown in which he injured himself."114 regardless ofwhich of these possibilities occurred, hughes's inappropriate confinement to this higher security facility resulted in an irreversible traged 115 y. . 3. higher costs for inmates in jails and prisons aside from the extremely high intangible costs, such as injury, death, and the general low quality of life for individuals with severe mental ill­ nesses caught up in this revolving door system, tangible cost is also a sig­ nificant factor in assessing whether the department of corrections is the right place for some mentally ill individuals. due to the need for increased staffing and individualized space, inmates who suffer from a mental illness are more costly than non-mentally ill inmates.116 mentally ill inmates stay in jail and prison longer.117 in one florida jail, the average stay in jail for the general gopulation is twenty-six days, versus fifty-one days for mentally ill inmates. 8 in new york riker's island jail, 42 days is the avera~e time for all inmates, but for the mentally ill the average is 215 days.1 the longer stays are due to the difficulty that mentally inmates have with under­ standing and following the jail rules.120 seriously mentally ill individuals also present large management prob­ lems because of their impaired thinking.12 an audit of three wisconsin state prisons in 2010 reported that "between 55 ~nt and 76 percent of inmates in segregation [isolation] are mentally ill."122 moreover, these in­ dividuals are often abused because the correctional officers in jails and prisons are not trained to work with the seriously mental ill.123 the officers 111. ld. at 12. 112. id. 113. id 114. id 115. id at 11-12. 116. torrbyet al.,supra note 75, at9. 117. id. at 10. l18. id. 119. ld. 120. id 121. id 122. ld. at 11. 123. ld. 676 indiana heal til law review [vol. 9:2 do not specifically apply to work with this subsection of the ~ulation, nor do they usually understand how to handle these individuals. 4 aot, how­ ever, helps alleviate the problem of these mentally ill individuals who do not belong in jail or prison through diversion to treatment instead . . d. evolution from civil commitment statutes aot statutes arose out of a growing need for a response or solution in lieu of the high standards that involuntary hospitalization (inpatient civil commitment) statutes maintain, and the lower costs of outpatient treat­ ment.125 these inpatient civil commitment statutes, or .. danger-or-grave­ disability statutes," typically require a showing, by clear and convincing evidence, of an imminent risk of either a danger to oneself of others, or a grave disability.126 such statutes exhibit major problems in execution, starting with the high level of proof required prior to such an order, clear and convincing evidence.127 the civil commitment statutes fail to protect both the safety of the mentally ill individual himself, and of the public.128 e. who these civil commitment statutes fail to protect aot statutes fail in part because: 124. id although a dangerous individual with mental illness may be involuntarily hospitalized, her commitment must be dismissed the minute she either ceases to suf­ fer from mental illness or ceases to be dangerous. many individuals with serious mental illness enter the hospital, frequently under court order, and remain hospitalized until they improve and no longer meet the standards for involuntary hospitalization .... left to their own devices, consumers often relapse and be125. see scherer, supra note 29, at 415. 126. ld at 366, 433; see also treatment advocacy ctr., assisted psyciuatric treatment: inpatient and outpatient standards by state (2011), available at http://www.treatmentadvocacycenter.org/storage/documentslnew_the_updated_state_standar ds_chart.pdf (detailing the key language of each state's civil commitment statute; language concerning dangerousness or risk of harm or injury is present in each); ind. code§ 12-7-253 (2006). 127. scherer, supra note 29, at 366. 128. id. ("for many severely mentally ill persons, this standard is nearly impossible to prove in a court of law and resultantly fails to protect a significant population of severely mentally ill persons: those who are in need of treatment but are neither dangerous nor disa­ bled to the extreme degree .... further, the danger-or-grave-disability statutes ... wait for moments of extreme deterioration to occur before permitting involuntary treatment, by which time it may be too late to effectively rehabilitate the individual."). 2012] revising assisted outpatient treatment statutes in indiana 677 come ill~ dangerous, and in need of rehospitalization.129 . ci;vil commitment statutes, as written, fail everyone. they provide lit­ tle help to individuals who suffer from debilitating illnesses and do not de­ liver enough insight (or time to develop insight while in the hospital) to make decisions on their own treatment. they fail to protect individuals' family members who must watch them suffer and have no ability to stop their deterioration. the statutes also fail to protect society and the victims that are hurt because of patients' psychotic episodes. these failures can all be alleviated, however, through a court-mandated system of assisted outpa­ tient treatment, whereby the individual will be monitored to ensure· compli­ ance with taking their medication or other forms of treatment. iii. model statutes/kendra's law a. kendra's law: the most prominent aot statute kendra's law is the new york assisted outpatient statute named after a specific victim, kendra webdale. kendra was a young woman who was pushed off a subway platform in new york city by a man with paranoid schizophrenia, who had just been released from hospitalization after failing to meet the "dangerous" requirement ofnew york's civil commitment stat­ utey0 according to the text of the statute, there are seven requirements that must be satisfied in order for a person to receive aot:131 (1) he or she must be at least 18 years old.132 (2) the individual must be suffering from a mental illness, as de­ termined by a mental health physician.133 (3) the individual must be ''unlikely to survive safely in the com­ munity without supervision, based on a clinical determination,''134 i.e., can he live safely on his own?135 (4) the individual must have "a history of lack of compliance with treatment for mental ill­ ness."136 this can be shown in one of two ways: (a) either psychi­ atric hospitalization or psychiatric treatment in a correctional facility at least twice within the previous two years; or (b) at least 129. kress, supra note 60, at 1295-96. 130. edie magnus, a deadly encounter, msnbc (jan. 20, 2007, 3:46 pm), http://www.msnbc.msn.com/id/16713078 . 131. see kendra's law, n.y. mental hyg. law§ 9.60 (mckinney 2006). 132. kendra's law, n.y. mentalhyg. law§ 9.60(cxi) (mckinney 2006). 133. id § 9.60(cx2). 134. id. § 9.60(cx3). 135. see scherer, supra note 29, at 387. 136. n.y. mentalhyg. law§ 9.60(cx4) (mckinney 2006). 678 indiana health law review [vol. 9:2 one overt act~ attempt, or threat of serious· physical harm to self or others within the previous four years.137 (5) the statute says that, "as a result of his or her mental illness, [the individual is] unlikely to voluntarily participate in outpatient treatment that would enable him or her to live· safely in the commu-· nity."i38 . . (6) in light of the individual's history and current behavior, he or · she is "in need of assisted outpatient treatment in order to prevent a · relapse or deterioration which· would be likely to result in serious harm to the person or others."139 · (7) lastly, the individual must·be "likely to benefit from assisted outpatient treatment."140 . . an additional provision notes that that the standard of proof for an in­ dividual to receive treatment under this statute is "clear and convincing evi­ dence."141 another provision allows third-person parties, described in the statute, to bring a petition to the court for· an individual to receive treat­ ment. 142 persons deemed appropriate to bring the petition include those who reside with the individual (and are at least eighteen years old), first­ degree relatives, medical professionals and police officers who have had experience with the individwi1..143 the statute further defines what types of treatment shall be administered144 and provides. that· ''treatment shall in­ clude case· management ·services or assertive community treatment team services to provide care coordination.,145 · . if an individual does not comply with the nuindate under this statute, he or she may be taken to the treatment provider's hospital for examination and treatment.146 however, if the individual does not meet the criteria set forth, the hospital may not retain the individual.147· the treatment period must last for a minimum of six ·months, but there may be a petition for renewal or modification}48 · 137. id. 138. id § 9.6q(cx5). 139. id § 9.60(cx6). 140. id. § 9.60(cx7). 141. id § 9.60(j). 142. id. § 9.60(e)(l). 143. id; scherer, supra note 29, at 391-93. 144. n.y.mentalhyg.law § 9.60(axi)(mckinney2006). 145. id 146. id. § 9.60(n). 147. id 148. id. § 9.60(1)(1). 20 12] revising assisted outpatient treatment statutes in indiana 679 1. weaknesses of the statute though kendra's law is a major step in the right direction toward treatment and de-criminalization of the mentally ill, some weaknesses do exist. the fourth criterion of the statute requiring .. a history of noncompli­ ance with treatment for mental illness,"149 is problematic. although includ­ ing the mentally ill individual's medical .history may expand upon the traditional civil commitment statutes, it still narrows the population to in­ clude only those individuals who have been hospitalized or incarcerated.150 therefore, treatment and medication received through an outpatient plan, such as the one proposed in this article, would.be inadmissible in determin­ ing whether the individual qualifies for outpatient commitment.151 this is a weakness of the statute as it fails to protect a larger population of severely mentally i1l individuals who may·not have received medication in an inpatient facility (quite possibly due to the lack of availability of a bed in a hospital or the public policy of pursuing . outpatient over inpatient treatment) or while incarcer­ ated.t52 . another weakness in kendra's law is that it could require '"criminal­ ization of the mentally ill' before it will step in to assist severely mentally ill persons."153 because the statute requires that the individual be arrested and medicated at least twice within the previous three years, if a patient does not meet both requirements, the courts cannot require treatment.154 unfortunately, many individuals would thus not be required to obtain treatment either because they were not medicated or were not formally charged.155 thus, feasibly the individual on the streets of indianapolis, who had been arrested eighty-three times in the course of three years, would not qualify for aot if there was no outside petition, even though he is likely a disturbed individual, if the arrests did not result in medication or formal charges. kendra's law is also deficient in that it omits younger individuals showing signs of a serious mental-illness, because of the three or four-year requirement of history resulting in forced medication.156 thus, those indi149. /d. § 9.60(c)(4). 150. scherer, supra note 29, at 387-88. 151. /d at 388. 152. /d. 153. id at 390. 154. /d. 155. id 156. id 680 indiana health law review [vol. 9:2 viduals must keep deteriorating to the point of homelessness, arrest, or re­ hospitalization after rehospitalization before aot will take effect.157 "medical research shows, however, that those who begin manifesting signs of a severe mental illness have the greatest chances for recovery if they re­ ceive treatment at earlier stages of the illness."158 this stricter requirement, however, does allow for a more narrowly tailored statute, likely in order to comply with constitutional requirements. b. other aot statutes other states have adopted aot statutes with various eligibility re­ quirements.159 north carolina was the first state to adopt aot, though its standard is less stringent than new york's.160 only four requirements must be met: (1) mental illness; (2) ability to live safely in the community with supervision from others; (3) treatment history showing the need for treat­ ment; and (4) lack of insight which would limit the individual's ability to make their own treatment decisions;161 north carolina has chosen a preventative approach to treatment. one study shows that the preventive approach is extremely successful in terms of treatment compliance for the revolving door patients.162 "this standard allows a patient's past history [to] serve[] as evidence of a need for treat­ ment; additionally, this 'past history' component ensures that only those patients who have demonstrated that they cannot, on their own, comply with treatment will be ordered to undergo treatment."163 · other states have implemented aot statutes that are similar to north carolina's, but usually some language differences exist.164 for example, georgia's aot statute states that the outpatient treatment chosen will ''min­ imize the likelihood of the patient's becoming an inpatient."165 in hawaii, the treatment compliance monitoring sets its aot statute apart from others.166 it states that the ''patient's status should not go un­ monitored, and all efforts should be made to ensure that the patients are tak­ ing their medication and complying with other forms of ordered treatment. only after all efforts have been made to effectuate the patient's compliance should a petition for involuntary commitment be filed."167 although each 157. see id. at 390-91. 158. id at 391. 159. winchell, supra note 19, at 223. 160. see n.c. gen. stat. § 122c-263(d) (1999). 161. ld; winchell, supra note 19, at 223. 162. winchell, supra note 19, at 223. 163. id. 164. id 165. id 166. ld at 223-24; see haw. rev. stat.§ 334-129(c) (1998). 167. winchell, supra note 19, at 223-24. 2012] revising assisted outpatient treatment statutes in indiana 681 state employs its own version of aot statutes, kendra's law has generally been considered to produce the most successful results.168 c. results of aot statutes/studies these statutes have &roven to be helpful in achieving the goals for which they are intended.1 a study of the effectiveness of kendra's law in new york has shown that new york's aot program has proven to be clearly effective in improving important outcomes for those who receive treatment under it. 170 additionally, the negative consequences that had ini­ tially been feared were virtually absent.171 those receiving treatment under aot were more successful in staying in treatment and subsequently being more productive citizens, if they were court-ordered to receive such treat­ ment for six months or more.172 further, improvements were more sustain­ able among those who continued intensive treatment or were ordered to aot for longer periods oftime.173 the 2009 new york study showed that arrests per month before and after aot, among those who were on treatment, decreased by forty-nine percent.174 the adverse conditions in the lives of the mentally ill partici­ pants substantially improved.175 the study showed a decrease in those who did not adhere to medications, in those who previously tried to harm them­ selves or to commit suicide, in those who previously tried to harm others, and those who were previously homeless.176 additionally, there was a twenty-one percent decrease in hospitalization (amongst those who were previously hospitalized) of patients who were in aot for six months, and a thirty-five percent decrease in those who were in aot for seven to twelve months.177 thus, generally, the 2009 n.y. study shows that aot works to reduce arrests and hospitalizations. another rffort done in new york in 2005, studied the effects of the aot statutes.17 this report also determined kendra's law to be a great 168. see generally marvin s. swarti et al, new york state assisted outpatient treatment program evaluation v-ix (2009}, available at http://www.omh.ny.gov/ omhweb/resources/publications/aot_program_evaluation/report.pdf; n.y. state office of mental healtii, kendra's law: final report on tile status of assisted outpatient treatment (2005). 169. swartz et al, supra note 168, at v-ix. 170. id. 171. !d. 172. !d. 173. !d. 174. !d. 175. id. 176. !d. 177. !d. 178. n.y. state0fficeofmentalhealth,supranote 168. 682 indiana health law review [vol. 9:2 179 a . . th d . success. mongst partlctpants ere was over seventy percent re uction in each of the key categories: hospitalization, homelessness, and arrests.180 the study also showed a dramatic drop in harmful behavior and a dramatic increase in medication compliance and long-term voluntary treatment com­ pliance.181 as a result, the new york office ofmental health recommend­ ed to the new york legislature that kendra's law 2005 sunset date be deleted and to extend kendra's law permanently.182 a study of the effectiveness of the north carolina statute on revolv­ ing-door patients found that those patients ordered to outpatient commit­ ment were more likely to attend their sessions at the community mental health centers to which they were assigned.183 almost all study partici­ pants, ninety-three percent, ordered to outpatient treatment were still in out­ patient treatment six months after their hearings, despite the fact that most of the outpatient commitment orders had terminated three months earlier and had not been extended.184 close to half of the patients studied ( 45.2%) never missed their appointments without giving an acceptable excuse and rescheduling.185 after a second failure to attend, over three fourths (77 .4%} of the patients attended their scheduled appointments and activities}86 '"given the characteristics of revolving door patients,' the authors of the study noted, 'psychosis, chronicity, dangerousness, multiple hospitaliza­ tions, and treatment refusal-4hese results represent a major accomplishment. ,,187 . one man who received forced treatment later stated that, "i refused treatment for almost three years after being diagnosed with bipolar disorder, all the while sinking into an increasingly dramatic symptomatic spiral. i was eventualty placed in treatment against my 'will.' and because i was-i got better."18 · 179. id 180. assisted outpatient treatment laws, supra note 21 (showing a 73% drop in hospitalization, a 76% drop in homelessness, and a 83% drop in arrests among the individu­ als participating in the program). 181. research on assisted outpatient treatment, mental illness policy 0rg., http://mentalillnesspolicy.org/aot/outpatient-commitment-research.html (last visited sept. 10, 2012) ("[t]he number of individuals exhibiting good adherence to medication increased by 103 percent (from only 34 percent to 69 percent) .... aot also promotes long-term volun­ tary treatment compliance."). 182. kendra's law: final report on the status of assisted outpatient treatment, supra note 168. 183. winchell, supra note 19, at 214. 184. see virginia aldige hiday & theresa l. scheid-cook, outpatient commitment for "revolving door" patients: compliance and treatment, 179 j. nervous & mental disease 83, 86 {1991). 185. id at 87. 186. id 187. winchell, supra note 19, at 215 (quoting hiday & scheid-cook, supra note 184, at 87). 188. jonathan stanley, personal results, treatment advocacy ctr., http://www. 2012] revising assisted outpatient treatment statutes in indiana 683 d. argument against aot statutes: constitutionality the main legal argument against aot statutes is that they affect a person's right to choose whether to be treated and thus challenges the con­ stitutionality of such statutes. however, while the constitutionality issues regarding aot statutes have not yet been heard by the u.s. supreme co~ new york has upheld aot statutes and kendra's law as constitutional.18 in the landmark decision of in re k.l, a man with schizoaffective disorder who did not regularly take his prescribed medications challenged the consti­ tutionality of kendra's law on the grounds that it violated his equal protec­ tion rights because the statute did not require a threshold finding of his incapacity to make his own treatment decisions.190 however, the new york court of appeals found that such a requirement was unnecessary, the mentally ill have never been deemed a protected class, and therefore the statute did not violate his equal protection rights.191 rational basis scrutiny is likely to apply to such claims because of the lack of protected class status if there are findings of discrimination. there are often "legitimate (if not compelling or substantial) reasons why individuals with relevantly different mental illness should receive differing forms of psychiatric treatment."192 as to the issues of due process, the court again found the statute to be constitutional because it was narrowly tailored and served a legitimate state interest.193 in essence, kendra's law was achieving a compelling state in­ terest under both police and parens patriae powers and was tailored nar­ rowly enough so as to overcome constitutional claims.194 thus, kendra's law was upheld on both . the procedural and substantive due process grounds for which it was challenged.195 with respect to the right to refuse psychiatric medication, the united states supreme court has identified the existence of a right to refuse medi­ cation, but only in inpatient hospitalization and incarceration contexts.196 further, the court need not ~ly strict scrutiny because it has never de­ fmed the right as fundamental. 7 there is room for a state to strike its own balance between the state's interest in medicating a patient in a controlled setting, such as a hospital, and a person's right to refuse medication.198 treatmentadvocacycenter.orglindex.php?option=com _ content&task=view&id= 19&1temid=48 (last visited. may 9, 2012). 189. in re k.l., 806 n.e.2d 480,486-87 (n.y. 2004). 190. /d. at 485-86. 191. city of cleburne v. cleburne living ctr., 473 u.s. 432,440 (1985). 192. scherer, supra note 29, at 406. 193. in re k.l., 806 n.e.2d. at486-87. 194. /d.; scherer,supranote29,at401-02. 195. in re k.l., 806 n.e.2d. at 486-87. 196. see washington v. harper, 494 u.s. 210, 229 (1990); mills v. rogers, 457 u.s. 291, 299 (1982). 197. scherer, supra note 29, at401-02. 198. /d. 684 indiana health law review [vol. 9:2 additionally, legislation supports the notion that aot statutes are in place in order to prevent incarceration and repeated inpatient hospitalization.199 so why there would be a higher standard for outpatient statutes, which are less restrictive on patients' rights, is unknown, and indeed unlikely?00 therefore, while the u.s. supreme court has not yet reviewed aot stat­ utes and a patient's right to refuse medication in that context, the standard of review is likely to be deferential to the statute.201 thus, while there have been no supreme court rulings regarding aot statutes as of yet, it is likely that they would be upheld as constitutional. n. indiana's aot statute a. indiana statute like other states, indiana. has a series of statutes that address aot?02 under indiana law, in order to receive aot, an individual must satisfy four criteria. they must be.(l) "[m]entally ill and either dangerous or gravely disabled;',2°3 (2) "[l]ikely to benefit from an outpatient therapy progrr!!l that is designed to decrease the individual's dangerousness or disability;',204 (3) not likely be either "dangerous or gravely disabled if the individual com­ plies with the therapy program;',zos (4) and "[r]ecommended for an ou~a­ tient therapy program by the individual's examining physician.' 06 unfortunately, however, the statute is rarely used by courts for involuntary treatment, except to transition some individuals from inpatient commitment to outpatient commitment. 207 b. weaknesses of indiana's statute this statute has many weaknesses which render the use of aot through a court order to be ineffective means of treatment. · the "dangerous or gravely disabled" language is clearly too high of a standard to meet for outpatient treatment, there is no standard of proof in the language, the stat­ ute gives no indication of whether 3rd party petitions are accepted, there is no time commitment required for treatment, there are no definitions of the terms, and most importantly, there are no guarantees of outpatient treatment 199. /d. at405. 200. /d. 201. /d. 202. ind. code§ 12-26-14-1 (2010). 203. id. 204. id. 205. /d. 206. /d. 207. flynn & esposito, supra note 26. 2012] revising assisted outpatient 'treatment statutes in indiana 685 placement. 208 one of the biggest challenges indiana will face if the statute is not changed is that there is no system in place to monitor the outpatient treatment program and, more importantly, compliance with it.209 without such a system, many seriously mentally ill individuals who lack insight into their disorder will not stay on the treatment course and will stop taking their medications, thus perpetuating the cycle?10 the lack of a strong aot stat­ ute in indiana law is unacceptable. 1. dangerous or gravely disabled the strict standard of "dangerous or gravely disabled" makes such a statute nearly indistinguishable from the inpatient civil commitment stat­ utes, and thus a very difficult barrier when petitioning for an individual who may otherwise need aot?ll this standard is difficult to meet when trying to get an individual civilly committed.z12 when the individual does not need civil commitment, but could survive in the community with outpatient treatment, this is an even harder burden to establish. in 1999, the department of justice reported that as much as 16 percent of the population of state jails and prisons, more than 260,000 individuals, suffer from severe mental illnesses. while the vast majority of these individuals are· arrested for non-violent crimes, it is inevitable that waiting for someone to become dangerous will culminate in violent episodes.213 such violence is insupportable when there is a better solution at hand. 2. no standard of proof there is also no standard of proof that the state must meet in order to satisfy the criteria of"dangerous or gravely disabled.',z14 with no standard of proof in the language, it is possible that a judgment could be made based on any amount of evidence presented. such lax standards with which to force· someone into involuntary treatment defy our society's justice system: they fly in the face of the constitutional guarantees against random judg208. ind. code§ 12-26-14-1 (2010). 209. interview with nami executive board, in indianapolis, ind. (feb. 12, 2011) (on file with author). · 210. ld. 211. see scherer, supra note 29, at 379-80. 212. ld. 213. torrey & zdanowicz, supra note 35. 214. ind. code§ 12-26-14-1 (2010). 686 indiana health law review [vol. 9:2 ments and unchecked police power. 3. lack of 3rd party petition ability the indiana statute does not give 3rd parties an ability to petition the court to have an individual evaluated for aot?15 this means that only individuals who have committed a crime and are brought before a judge are eligible for this type of treatment. meanwhile, others who are on the street or elsewhere in need of treatment, are ineligible. family members will be left helpless and frustrated with the system. this is not how indiana should treat its citizens. 4. no mandated time commitment under the statu~ as it currently stands, no minimum period of time that a patient who is mandated to aot must undergo the treatment ex­ ists.216 though the needed period of time will vary in different cases, there must be some minimal starting-off point. without that, and without guid~ ance as to how much time must be given for the treatment to start· working, it is possible that a mentally ill individual could go to treatment for only one week, or even one day for that matter, and still fulfill the requirements set out by the statute. this, however, is not nearly enough time for such treat­ ment and is an unacceptable standard. 5. no definitions for the terms one major flaw in the statute is the lack of definitions of terms?17 this makes it very difficult to interpret and apply the statute. for instance, while the terms "dangerous" and '"gravely disabled"' may have been given meaning in other statutes for civil commitment, their meanings here could be very different. the difference is in the liberty interest that is restricted. one's liberty is much more greatly restricted in an inpatient hospital setting, as with inpatient commitment, than it is when being medically monitored outside in the free world, as in an outpatient setting. however, these terms, and others like them in the statute, could also indicate an entirely different meaning than what is given to them in civil commitment statutes. it is un­ clear from the language as it stands of what is truly meant and how the court should interpret the terms. 215. id 216. id 217. id 2012] revising assisted outpatient treatment statutes in indiana 687 6. no guarantees ofoutpa(ient program placement finally, as the statute is currently written and applied, there are no guarantees of placement into an outpatient progr~ even if the court does find that the individual qualifies under the statute.21 without such guaran­ tees by the state, there will likely not be enough physicians or other medical professionals on stafr to assist these individuals, and they will fall by the wayside as in the past. even with assertive community treatment (act) teams to do the more hands-on work with the individual, there would need to be a supervising psychiatrist that the court would look to in its assess­ ment.219 as it is, the state is consistently cutting the budget of mental health services. 220 without guarantees that someone will be treated or placed in the program, courts will be unlikely to use such statutes. c. results of indiana's statutes indeed, as the indiana statutes are currently written, aot is rarely used by the court in lieu of imprisonment or a simple release without treat­ ment-after arrest for a small misdemeanor.221 that is not to say that indiana is doing nothing to help the mentally ill. there are several programs insti­ tuted to help for those who voluntarily would seek admission to an outpa­ tient program, such as pair; or for crisis intervention· training (cit) officers, who are being trained on how to properly re~ond to situations involving the mentally ill, in lieu of the standard arrest.2 however, in in­ dian~ there are approximately 250,000 hoosiers with a serious mental ill­ ness. 23 given the lack of insight associated with such conditions, most of these people,lefluntreated, will end up homeless or injail. additionally, at any given time the indiana department of corrections hoids over 4000 peo­ ple with a serious mental illliess and only a very small percentage of them are·on any kind of psychiatric medication.224 thus, in order to fight for the rights of the mentally ill to a better quality of life, the aot statutes must be amended, if not completely re-done. 218. id. 219. parlcer,supranote27. 220. ld. (stating that the division of mental health and addiction (dmha} is currently in the process oftransinoning 1200 state hospital beds to 850}. 221. flynn & esposito, supra note 26. 222. collins, supra note 28. 223. parker, supra note 27. 224. id. (only fifteen percent of those seriously mentally ill inmates in the indiana doc are on medication). 688 indiana health law review [vol. 9:2 v. revised aot sta1ute proposal for indiana ·a. kendra's law with modifications the introduction to the model law for assisted treatment states that: "perhaps the single most important reform needed to prevent the need for repeated hospitalization and to prevent the consequences of non-treatment is to encourage the use of assisted outpatient treatment.',z25 indiana thus needs to reform its aot statutes in order to accommodate for the increasing need for treatment of its seriously mentally ill citizens. one important reform that should be administered in the statute is that it should be proactive. currently, the aot statutes in place are fairly retro­ active in nature in that they are applied to individuals who have gone through the system repeatedly, and have been in and out of jails or home­ less for a long period of time. the court should take a proactive approach and include a broader class of people who can petition the court as a 3rd party. the court should also order psychological evaluations on individuals who exhibit signs of a severe mental illness while in jail. with these re­ forms the revolving door may be less active and incidences of violence, homelessness, and unnecessary arrests would go down, and quality of life for certain individuals would go up. included in this reform should be a discharge/treatment plan for any­ one that is seriously mentally ill and is. discharged from an outpatient pro­ gram, a long hospitalization, or prison or jail in order to reintegrate them into society. often, a mentally ill individual just released from jail or frison will be set free without any type of re-integration or treatment plan.22 fur­ ther, if the person was receiving medication in jail or prison, there is a lapse between the time when they are released and the time when they may re­ apply for medicare benefits in order to continue treatment. 227 if things run very smoothly on all sides, even then it would take a minimum of ninety days for someone to get approved for their benefits again8 yet so often things do not run smoothly with administrative agencies?2 as such, it would take much longer than three months in order to receive treatment.229 225. torrey & zdanowicz, supra note 35. 226. interview with trina randall, public information officer, new castle correctional facility (feb. 3,2011). 227. interview with nami executive board. supra note 209; collins, supra note 28. 228. michael w. kempf, nami indiana, mental illness and tile criminal justice system in indiana 24 (2008}, available at http://www.nami.org/content/micrositesl69/ nami_indiana/homel56/resources87/kempf_report_6_13_2008.pdf ("a case manager for midtown mental health indicates that in a perfect world. it takes a minimum of 90 days to get someone approved and we do not live in a perfect world. clients who have been in­ carcerated often do not have the identification and other requirement to begin the application process."). 229. id. 2012] revising assisted outpatient treatment statutes in indiana 689 this is unacceptable. a re-integration or immediate treatment plan needs to be available to the individual upon release, so no reversion back to the ano­ sognosia symptom occurs, and patients are given them a chance to be a productive citizen with a higher quality of life than they would have with­ out treatment. a treatment plan should include but not be limited to: "suggested medication; individual or group therapy; day or partial day programming activities; services and training, including educational and vocational activi­ ties; residential supervision; intensive case management services; and living arrangements.',23o however, the housing to be arranged needs to be less strict about rule adherence, so that it is easier for a mentally ill individual to ~om:plv, without the constant threat of being evicted for a minor infrac­ tion?31 in order to help more homeless or runaways, the criteria for someone being able to petition the court for aot should also be lessened to anyone with a good faith belief that aot is absolutely necessary.232 there should be a criminal penalty for false petition in order to deter this provision from being used in the wrong way (vengefully or without a true motive of help­ ing the person).233 according to the model law for assisted treatment, the language should read: "it shall be a crime to knowingly file, or cause to be filed, a petition that contains a false material statement or infor­ mation. ,,234 in order to account for this shift in the mentally ill person's civil rights, there should be further constitutional rights afforded to him when he is brought before the court. included in the statute should be a ''formal grievance procedure whereby patients c~ bring complaints to the facili~'s medical director and, if necessary, to the psychiatric treatment board.' 35 more significantly, there should be a provision to safeguard the bodily in­ tegrity of the mentally ill individual, i.e. an examination of the individual for medication side effects every thirty days by either a psychiatrist or phy. . 236 slclan. · also needed is a provision stating that the treatment must be the least restrictive available that will meet the patient's clinical needs. the patient 230. jonathan stanley, important aspects of the model law, in model law for assisted treatment § 14.3 (2000), available at http://www.treatmentadvocacycenter.orgl generalresources/index.php?option=com_ content&task=view&id=49&ltemid=78. 231. kempf, supra note 228, at 23 ("group homes and other housing arrangements have attempted to meet the needs of this population, but often, the administrative rules governing acceptance into a group home or rules governing the behavior of the residents are applied so strictly that the individual with a mental illness is turned out on the street if the rules are broken."). 232. stanley,supranote230, § 5.1. 233. /d. § 5.6. 234. /d. 235. stanley, supra note 188. 236. /d. 690 indiana health law review [vol. 9:2 should be placed on either intensive case· management or assertive commu­ nity treatment ("act") if available. if a supervising physician approves, and it is appropriate, the individual may be able to fulfill his or her aot obligations at his or her own residen~ or at a treatment center or group home, whichever the patient chooses.2 7 if they fail to comply with the aot program, the reprimand should not be jail, but more appearances be­ fore the judge, to ensure they will comply. the individuals who comply with treatment should be rewarded by progressively fewer court appearanc-: es and less supervision, much like the pair program.238 finally, it would be important to move the standard of proof required to show that the individual qualifies to the beginning of the statute, instead of being mixed with other language in the middle. this will make it easier for the court to determine whether the standard has been met and what kind of evidence is necessary. vi. funding funding is a crucial and often overlooked question to address when discussing implementation or revision of aot statutes. funding is a major problem in our mental health s~tem for providing the severely mentally ill assisted outpatient treatment? 9 a majority of the aot funding goes to treatment of individuals in inpatient programs or hospitals?40 as a result, the essential resources needed to obtain the proper number of clinicians and other psychology-related personnel required to move such a pro~ for­ ward and treat the individuals on an outpatient basis are lacking. "1 thus, funding becomes an issue of great importance. "it is a mistake to think that money is saved overall by not treating in­ dividuals with severe psychiatric disorders. ,,242 those left untreated cost the state and federal government much more money through their repeated incarcerations.243 the total cost in jails and prisons alone is estimated by the department of corrections to be over $15 billion?44 each year, un­ treated mental illness costs the united states $100 billion or more because of unemployment, homelessness, inappropriate incarceration, and sui237. stanley,supranote230, § 7.:r-7.6. 238. collins, supra note 28. 239. interview with nami executive board, supra note 209. 240. id. 241. id 242. treatment advocacy ctr., consequences of non-treatment, http://www. treatmentadvoca­ cycenter.orglindex.php?option=com_content&task=view&id=l384&itemid=221 (last visited mar. 26, 2012). 243. id. 244. jd. 2012] revising assisted outpatient treatment statutes in indiana 691 cide.245 more importantly, "[t]he largest intangible cost, of course, is the effect on the family.'.246 however, there are ways to reduce these costs and even to obtain funding from the government in order to subsidize aot pro­ grams. a. benefits of aot: reduction in hospital costs a usable aot statute in indiana would lead to a reduction in hospital­ ization costs.247 inpatient care is the most expensive form of mental health treatment. in the past ten years, mental health care costs have risen in response to higher psychia­ trist's fees and prescription costs. patients caught in the revolving door, under current statutes, typically end up spending sporadic periods of time in a mental hospital, and this time quickly adds up.248 studies show that people who are treated with aot spend less time in hospitals and prisons, thus reducing costs of accommodating them. 249 therefore, while funding may be an issue initially, long term it will be off­ set by other costs no longer present. b. funding through medicaid or taxes funding may also be found by applying to medicaid for reimburse­ ment of psychiatric services.250 medicaid provides some funding to hospi­ tals and individuals with a serious mental illness who are in need of treatment/medication.251 states should receive increased medicaid contri­ butions for any psychiatric or medical services provided through aot as it replaces its inpatient hospitalization services counterpart.252 in 2001, the new freedom initiative was launched to "promote full access to communi­ ty life for people with disabilities. ,,253 this initiative included mental health 245. nat'l awance on mental illness ind., supra note 45. 246. 'treatment advocacy ctr., supra note 242. -247. winchell, supra note 19, at 226. 248. ld. 249. ld at 227-28. 250. kress, supra note 60, at 1352. 251. /d. 252. id (citing 42 u.s.c. § 1396(a)(xi)(l) (1999)). 253. u.s. dbp't healm: and human servs., substance abuse & mental health servs. admin., transforming mental healm: care in america (2010), http://www. samhsa.gov/federalactionagenda/nfc_execsum.aspx. 692 indiana health law review [vol. 9:2 care254 and builds on the americans with disabilities act, emphasizing the ''requirement that services be provided to the maximum practicable extent within the community rather than in institutional settings.'.2ss alternative­ ly, a 1% tax increase on those who earn over $1 million would generate a great deal of revenue, like in california, where the mental health services act provided funding for mental health programs.256 while this act was implemented only for treatment on a voluntary basis,257 there is no reason why the revenue could not help support both voluntary and involuntary treatment in indiana. vll. conclusion [many individuals with a serious mental illnes] are unaware they are sick and should be required by law to receive assisted outpatient treatment, including medication and counseling, as is the case in new york under kendra's law. if they do not comply with the court-ordered treatment plan, they can and should be involuntarily admitted to a hospital .... ul­ timately, it is important to hold state officials respon­ sible for not providing sufficient resources to treat · those who suffer from serious mental illnesses . . . . state governments have been very effective in empty­ ing the hospitals in an effort to save money but re­ markably ineffective in providing treatment for seriously mentally ill individuals living in the community.2ss . if the state of arizona had a more effective aot statue, perhaps the tragedy perpetrated by jared loughner could have been avoided. by man­ dating treatment when school and police officials recognize the signs of mental illness, future tragedies may be prevented. if so, the lives of not on­ ly the victims in the shooting, but also of the unwitting perpetrators, may be saved. it is an important function of the government to not only care for individuals the state deems worthy or less burdensome, but also to care for those individuals that are left behind by the system and need greater care. all citizens deserve protection of the state, yet some are discarded by that same body who long ago promised to afford everyone the same opportuni­ ties, rights and protections. states must now step up and do their part in 254. /d 255. id 256. scherer, supra note 29, at 426-27. 257. /d. at427. 258. torrey, supra note 2. 2012] revising assisted 0u1patient treatment statutes in indiana 693 providing preventative treatment for seriously mentally ill individuals. this goal can be achieved through aot. i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i ii ii ii ii ii ii i i i i i i a survey of three patent-based approaches that may play a role in drug prices megan fuller* i. an introduction to the interplay between patents and drug prices the founders considered intellectual property (“ip”) rights so important toward the goal of producing technological advances to benefit society at large that they codified them in the u.s. constitution.1 today, ip rights, including patent rights, can play an important role in the development and pricing of prescription drugs.2 patents are particularly important because the u.s. patent and trademark office (“uspto”) grants patent holders a temporary “monopoly” on their new inventions or products – a practice essential to the pharmaceutical industry due to the need to recoup the substantial amount of money that was invested in research and development.3 as a reward for their innovation, patent holders generally have exclusive rights “to make, use, sell, or import” their invention within the u.s. for a period that begins when the patent is issued by the uspto and ends approximately twenty years from the date the applicant applied for the patent.4 during this time, the “monopoly” is in effect, and competition from generic companies is delayed.5 upon expiration of a patent’s exclusivity,6 generic or biosimilar products can * j.d. candidate, 2021, indiana university robert h. mckinney school of law, indianapolis, indiana; m.s., 2014, michigan state university, east lansing, michigan; b.s., 2010, purdue university, west lafayette, indiana. any views expressed herein are my own and do not necessarily reflect the views of my employer. 1. see u.s. const. art. i, § 8, cl. 8 (“the congress shall have power . . . [t]o promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”) 2. see kevin j. hickey et al., cong. research serv., r45666, drug pricing and intellectual property law: a legal overview for the 116th congress 1 (2019), https:// crsreports.congress.gov/product/pdf/r/r45666 [https://perma.cc/kbx4-khjn]. 3. see joseph a. dimasi et al., innovation in the pharmaceutical industry: new estimates of r&d costs, 47 j. health econ. 20 (2016). research showed that the average cost to develop and secure approval of a new medicine in 2013 was $2.6 billion dollars, considering trial and error, the research failures along the way, and the cost of capital. see id. also, note that the dimasigrabowski approach to pricing is one, but not the only, approach to pricing in the u.s. in the u.s., value-based and cost-plus approaches are also used, among others. 4. 35 u.s.c. §§ 154(a)(2), 271(a) (2020); see also hickey et al., supra note 2, at 3. 5. hickey et al., supra note 2, at 4 (stating that “pharmaceutical products are frequently protected by ip rights, and some studies have shown that ip rights are the most important factors driving high drug prices. for example, [the] fda has found that increased competition from generic drug manufacturers is associated with lower prices for pharmaceuticals”). 6. kevin o’connor, how patents play a role in drug pricing, pharma letter (jan. 19, 2018), https://www.thepharmaletter.com/article/how-patents-play-a-role-in-drug-pricing 398 indiana health law review [vol. 18:397 enter the market, driving the price of the product down.7 this change can be significant: the first generic competitor’s product is typically offered at a 20-30% discount, and subsequent generic entry can push the price down to 15%, or even less, of the product’s original price.8 notably, “many factors other than ip rights contribute to” pharmaceutical drug prices.9 furthermore, while there are significant government interventions on pricing within government programs (i.e., mandatory rebates, consumer price index penalties, or best price provisions in medicaid), the u.s. currently has no direct price controls on pharmaceuticals.10 the complexities of drug pricing extend far beyond a single law review note. however, this note examines three patent law approaches that have recently made substantial impacts on drug prices and drug pricing legislation. first, this note examines the doctrine of patent exhaustion and, subsequently, the patent practices of “patent thicketing” and “product hopping.” it analyzes the impact of each on the price of pharmaceuticals in the u.s. this note begins with section ii, analyzing the doctrine of patent exhaustion, which has an important relationship to recently publicized legislation that proposes prescription drug re-importation from canada. further, section ii explains how a 2017 u.s. supreme court decision, coupled with proposed health law legislation by the u.s. department of health and human services (“hhs”), could potentially enable pharmaceutical drug re-importation into the u.s. from canada as a means of lowering u.s. drug prices.11 section ii is divided into four subsections: (a) an overview of the landscape of re-importation of pharmaceuticals into the u.s. from canada; (b) the legal relationship between a recent u.s. supreme court decision and international patent exhaustion; (c) how the international exhaustion doctrine might affect the market prices of pharmaceuticals; and (d) how the current hhs has designed legislation to target pharmaceutical drug re-importation and u.s. price controls. the next two sections of this note describe practices by patentees (e.g., pharmaceutical manufacturers) purportedly designed to extend or maintain the [https://perma.cc/ub4t-qtzu] (discussing how regulatory exclusivity, in addition to patent exclusivity, plays a role in drug pricing). 7. id. 8. id. 9. hickey et al., supra note 2, at 4. examples of some of these factors include “demand, manufacturing costs, r&d costs, the terms of private health insurance, and the involvement of a government insurance program such as medicaid,” to name a few. id. 10. see international trade and pharmaceuticals: joint hearing before the subcomm. on int’l trade & the subcomm. on health care of the s. comm. on fin., 108th cong. 1-3 (2004) (statement of sen. jon kyl, chairman, subcomm. on health care). 11. see generally graham o’donnell, the next step in the battle against high pharmaceutical prices: lexmark & the dscsa have paved the way for parallel, 46 fla. st. u. l. rev. 197 (2018); see also safe importation action plan, u.s. food & drug admin. (july 31, 2019), h t tp:/ /www.hhs.gov/sites/defau lt / f iles/safe-importat ion-act ion-plan .pdf [https://perma.cc/z4vs-dpgw] [hereinafter safe importation action plan]. https://perma.cc/z4vs-dpgw 2021] a survey of three patent-based approaches 399 market exclusivity of a particular product. section iii details “patent thicketing.” patent thicketing is a nickname for one of these practices, and it is a strategy purportedly employed by some pharmaceutical manufacturers that aim to extend the duration of the patent “monopoly” by protecting the product with as many additional patents as possible, thus creating a so-called “thicket” around the product. next, section iv addresses the so-called practice of “product hopping,” in which the pharmaceutical company allegedly replaces its branded drugs with slightly modified versions. product hopping could prevent generic pharmaceutical drug entry because the original pharmaceutical drugs must be on the market for regulatory purposes. because product hopping is complex, section iv is further divided into two subsections. subsection a describes “hard switches” – the quintessential product hopping scenario in which a pharmaceutical company takes the original drug completely off the market. subsection b discusses “soft switches” – the less forceful process in which a pharmaceutical company disparages the original form of the drug, making the generic version more difficult to obtain. this note concludes with a summary about the interplay between patent law and the cost of prescription drugs, as drug pricing remains “at the forefront of discussions among patients, advocacy groups, prescribers, payers, pharmaceutical companies, and policy makers.”12 the number of people interested in this issue, coupled with current legislation targeting these practices, may result in near-term changes to drug prices in the u.s. it should be mentioned that many other patent practices exist in the context of drug pricing (e.g., sham litigation, abuse of the food and drug administration’s risk evaluation and mitigation protocol, or abuse of the food and drug administration’s citizen petition process), but these issues are beyond the scope of this note.13 ii. patent exhaustion & drug re-importation a. re-importation of lower cost pharmaceuticals into the u.s. from canada in 2003, legislators made changes to the food, drug, and cosmetics act (“fdca”) that provided the secretary of hhs with the legal authority to import prescription drugs from canada.14 despite this law being enacted over a decade ago, numerous hurdles prevented large-scale re-importation from canada, one of which is the u.s. doctrine of patent exhaustion.15 12. o’connor, supra note 6. 13. see generally kerstin noelle vokinger et al., strategies that delay market entry of generic drugs, 177 jama internal med. 1665 (2017). 14. medicare prescription drug, improvement, and modernization act of 2003, pub. l. no. 108-173, 117 stat. 2066. this public law is better known as the law that created medicare part d. 15. patent rights and pharmaceutical reimportation, gen (nov. 1, 2005), https://www. genengnews.com/magazine/38 /paten t-r igh ts-and-pharmaceutica l-r eimportat ion / 400 indiana health law review [vol. 18:397 under the doctrine of patent exhaustion, when a pharmaceutical manufacturer or licensee distributes patented medicines within the u.s., the patent rights with respect to these drugs are effectively terminated,16 and the purchaser and all subsequent owners are free to use or resell the product just like any other item of personal property without fear of an infringement lawsuit.17 however, the law has historically been unclear as to how this applies to international patent exhaustion. this means that, in the past, authorized sales and the corresponding distribution of patented medicines by pharmaceutical manufacturers to countries outside the u.s. (e.g., direct sales of a drug to canada) would not terminate u.s. patent rights to that drug; or, at least, the law has historically been unclear on this point.18 therefore, most people believed that re-importation of medicine initially sold or distributed to a foreign country, and then re-imported back into the u.s., would be considered an act of patent infringement.19 this rule is important to pharmaceutical re-importation because prices are lower in canada and many other foreign countries than they are in the u.s.20 one reason for this is that some governments (e.g., canada) “are the primary or only payer of health care and in effect [can] dictate the prices of medicines as a condition of market access.”21 therefore, pharmaceutical companies wanting to make their products available in canada may be forced to sell their product at a lower price in canada than in the u.s.22 in contrast, the u.s. does not participate in direct regulation of the prices that pharmaceutical manufacturers charge for their products, and the list price in the u.s. is often higher than in other industrialized nations, even though the actual price to the consumer often includes discounts, savings programs from the manufacturer, and negotiated out-of-pocket costs from the consumer’s insurer or pharmacy benefit manager.23 [https://perma.cc/8esk-g6ul]. 16. id. 17. impression prods., inc. v. lexmark int’l, inc., 137 s. ct. 1523, 1535 (2017). 18. patent rights and pharmaceutical reimportation, supra note 15; see also jazz photo corp. v. int’l trade comm’n, 264 f.3d 1094 (d.c. cir. 2001) (holding that a patentee’s decision to sell a product abroad did not terminate its ability to bring an infringement suit against the buyer that imported the article and sold it in the u.s.); quanta computer, inc. v. lg elecs., inc., 128 s. ct. 2109, 2122 (2008) (holding that the patentee could not bring an infringement suit because the “authorized sale . . . took its products outside of the patent monopoly”). 19. 35 u.s.c. § 271(a) (2020) (“except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the [u.s]. or imports into the [u.s]. any patented invention during the term of the patent therefor, infringes the patent.”). 20. see panos kanavos et al., higher us branded drug prices and spending compared to other countries may stem partly from quick uptake of new drugs, 32 health aff. 753 (2013). 21. kevin haninger, setting the record straight on international reference pricing, catalyst (july 16, 2019), https://catalyst.phrma.org/setting-the-record-straight-on-internationalreference-pricing [https://perma.cc/mlx7-gjbh]. 22. id. 23. topher spiro et al., enough is enough; the time has come to address sky-high drug prices, ctr. for am. progress (sept. 18, 2015), https://www.americanprogress.org/issues/ 2021] a survey of three patent-based approaches 401 canada sets its prices for patented medicines at the federal level through a quasi-judicial agency called the patented medicine prices review board (“pmprb”).24 the pmprb also places price caps after a prescription drug appears on the canadian market. the price charged each successive year can rise only with the rate of inflation.25 however, to paint a fair picture of this process, canadians generally have less access to patented medicines.26 in addition to patent exhaustion concerns, the passage of drug importation legislation in 2003 has been further hindered by complex legal, regulatory, and safety concerns.27 also, there have been numerous failed attempts to implement importation.28 however, on july 31, 2019, hhs and u.s. food and drug administration (“fda”) issued a federal “safe importation action plan,” proposing two pathways to allow for the importation of drugs from canada.29 with the proper framework for drug safety assurances,30 legislative support from individual states,31 and the recent u.s. supreme court decision regarding international patent exhaustion,32 the necessary logistics of parallel importation are increasing in probability. healthcare/report/2015/09/18/121153/enough-is-enough/ [https://perma.cc/884m-yqwk]. 24. patented medicines prices review board, gov’t can., https://www.canada.ca/ en/patented-medicine-prices-review.html [https://perma.cc/r5ql-gkya] (last visited mar. 14, 2021). 25. patented meds. prices review bd., gov’t of can., compendium of policies, guidelines and procedures 45 (2017), http://www.pmprb-cepmb.gc.ca/view.asp?ccid=492# 1645 [https://perma.cc/h6dp-6k9j#1645] (stating that the price of an existing patenting drug cannot increase by more than the consumer price index). 26. brad millson et al., innovative meds. can., access to new medicines in public drug plans: canada and comparable countries 23 (2016), http://innovativemedicines. ca/wp-content/uploads/2016/05/20160524_access_to_medicines_report_en_web.pdf [https://perma.cc/u6mv-z9rq]. in a 2016 report by innovative medicines canada, comparing canada to the twenty highest gdp nations, canada ranked eighteen out of twenty, with only 37% of new medicines being reimbursed across the country. id. at 5. canada also ranked low for the length of time before reimbursement was granted in public drug plans, taking on average 449 days from new drug approval to reimbursement. id. at 6. 27. see, e.g., monali bhosle & rajesh balkrishnan, drug reimportation practices in the united states, 3 therapeutics & clinical risk mgmt. 41 (2007). 28. see, e.g., id. 29. safe importation action plan, supra note 11. 30. see o’donnell, supra note 11 (discussing the necessary safety frameworks for safe pharmaceutical drug importation). 31. steven findlay, states pass record number of laws to reel in drug prices, kaiser health news (sept. 9, 2019), https://khn.org/news/states-pass-record-number-of-laws-to-reel-indrug-prices/ [https://perma.cc/q7ps-t92e] (stating that four states – colorado, florida, maine, and vermont – established protocols in 2019 to begin the process of importing prescription drugs from canada). 32. see impression prods., inc. v. lexmark int’l, inc., 137 s. ct. 1523 (2017). https://perma.cc/q7ps-t92e 402 indiana health law review [vol. 18:397 b. international patent exhaustion & the lexmark decision prior to the lexmark decision, even if the u.s. promulgated legislation that allowed for parallel drug importation, the doctrine of patent exhaustion would have precluded the sale of these imported pharmaceutical drugs in the u.s.33 the facts and issues decided in lexmark are thus instructive as to how re-importation questions may be resolved legally going forward. lexmark international, inc. (“lexmark international”) designed, manufactured, and sold toner cartridges to customers in the u.s. and globally.34 lexmark international owned several patents that covered components of their print cartridges and the manner in which they were used.35 when toner cartridges ran out of toner, they could be refilled and reused again.36 however, this created an opportunity for other companies – known as remanufacturers – to acquire empty lexmark international cartridges from purchasers in the u.s. and abroad, refill them with toner, and then resell them at a lower price than the ones lexmark international put on shelves.37 in an attempt to combat this problem, lexmark international structured its sales in a way that encouraged customers to return their empty cartridges back to them.38 one means by which lexmark international attempted to do this was to incentivize its customers to purchase a cartridge at a discount through a “return program.”39 a customer who bought a cartridge through this program still owned the cartridge, but, “in exchange for the lower price, sign[ed] a contract agreeing to use it only once and to refrain from transferring the empty cartridge to anyone but lexmark [international].”40 further, lexmark international “install[ed] a microchip on each return program cartridge” that would further dissuade customers to reuse them.41 despite these efforts, however, remanufacturers continued to successfully buy and refill lexmark international cartridges, albeit more creatively.42 one issue was that the company’s “contractual single-use/no-resale agreements were with the initial customers, not with downstream purchasers like remanufacturers.”43 the lexmark decision thus presented one major question about the scope of the patent exhaustion doctrine that will become important to this note’s discussion of the re-importation of pharmaceuticals later: whether patent rights 33. see generally jazz photo corp. v. int’l trade comm’n, 264 f.3d 1094 (d.c. cir. 2001); see generally quanta computer, inc. v. lg elecs., inc., 128 s. ct. 2109 (2008). both seemed to imply that u.s. patent rights were not extinguished by an international sale. 34. impression prods., inc., 137 s. ct. at 1529. 35. id. 36. id. 37. id. 38. id. 39. id. at 1529-30. 40. id. at 1530. 41. id. 42. id. 43. id. 2021] a survey of three patent-based approaches 403 are exhausted when a patent owner sells its product outside of the u.s.44 the u.s. supreme court concluded that a patentee’s decision to sell a product “exhausts all of its patent rights in that item, regardless of any restrictions the patentee purports to impose” on the location of the sale, meaning that the patent owner may not use patent law to follow the product down the stream of commerce and sue subsequent purchasers for patent infringement.45 importantly, the u.s. supreme court noted that “even if the restrictions in [lexmark international’s] contracts with its customers were clear and enforceable under contract law, they do not entitle lexmark [international] to retain patent rights in an item that it has elected to sell.”46 c. how patent exhaustion can affect the market prices of prescription drugs to illustrate what could happen with the doctrine of patent exhaustion and pharmaceutical drug prices, it may be useful to study how a ruling by the u.s. supreme court on a similar intellectual property doctrine, the “first sale” doctrine of copyright law, influenced the prices of textbooks sold internationally. in 2013, a lawsuit between a major book publisher and a u.s. college student ensued after the student imported and resold textbooks in the u.s. that had been priced lower abroad.47 when kirtsaeng, the petitioner and a college student, moved from thailand to the u.s. to study mathematics at cornell university, “he asked friends and family to buy foreign edition english-language textbooks in thai bookshops, where they [were] sold at low prices, and to mail them to him in the [u.s.].”48 he then sold the books for a profit in the u.s. and reimbursed his family and friends.49 under the first sale doctrine of copyright law, when a copyright owner sells a lawfully made copy of its work, it loses the power to restrict the purchaser’s freedom “to sell or otherwise dispose of . . . that copy.”50 however, like lexmark, prior to kirtsaeng, the court had not ruled on whether this doctrine applied to the sale of works made and sold abroad.51 the u.s. supreme court granted kirtsaeng’s petition for certiorari and held that the first sale doctrine applies to copies of a copyrighted work lawfully made abroad.52 the u.s. supreme court in kirtsaeng stated that what tipped the scales toward a global exhaustion policy was the fact that the first sale doctrine 44. id. at 1529. 45. id. at 1535 46. id. at 1526. 47. see kirtsaeng v. john wiley & sons, inc., 133 s. ct. 1351 (2013). 48. id. at 1356. 49. id. 50. 17 u.s.c. § 109(a) (2020). 51. impression prods. v. lexmark int’l, inc., 137 u.s. 1523, 1527 (2017). 52. kirtsaeng, 133 s. ct. at 1351. 404 indiana health law review [vol. 18:397 originated in “the common law’s refusal to permit restraints on alienation of chattels.”53 the court expressly acknowledged that its decision was likely to impact prices, noting that “[a] publisher may find it more difficult to charge different prices for the same book in different geographic markets” but also that they could “find no basic principle of copyright law that suggests publishers are especially entitled to such rights.”54 notably, justice ruth bader ginsburg dissented in both the lexmark and kirtsaeng decisions. as the protections of the patent act have no extraterritorial effect, justice ginsburg argued that “it makes little sense to say that such a sale exhausts an inventor’s u.s. patent rights.”55 this echoed the same position that justice ginsburg took when dissenting in kirtsaeng, where she argued that a foreign sale should not exhaust u.s. copyright protections.56 regardless, most economists believe that parallel importation will result in more uniform pricing: namely, lower u.s. prices and higher prices abroad.57 in its best-case scenario, the establishment of international exhaustion will align u.s. patent law with free trade principles, decreasing international price discrimination.58 notably, there is no uniform agreement on this point. the fact that mandatory exhaustion will benefit u.s. consumers’ pocketbooks does not mean that mandatory exhaustion will increase u.s. citizens’ welfare overall.59 it is not yet clear whether the advantages to u.s. customers will outweigh the losses to u.s. patent holders and how that will affect the industry long-term.60 in fact, a law school professor at the university of pennsylvania argued against the u.s. supreme court’s patent exhaustion rule, calling it “draconian” and “indifferent to effects on innovation” because “[n]o further inquiry is made into the patentee’s market power, [anti-competitive] effects, or other types of harms, whether enforcement of the condition is socially costly or valuable, or has a positive or negative impact on innovation.”61 53. id. at 1363. 54. id. at 1370. 55. impression prods, 137 u.s. at 1539. 56. kirtsaeng, 133 s. ct. at 1373. 57. daniel j. hemel & lisa larrimore ouellette, trade and tradeoffs: the case of international patent exhaustion, 116 colum. l. rev. 17, 24-26 (2016). 58. sarah r. wasserman rajec, impression products, inc. v. lexmark inc.: will international patent exhaustion bring free trade in patented goods, patently-o (june 1, 2017), h t tps:/ /paten tlyo.com/paten t/201 7 /0 6 /impression-in ternational-exhaust ion .h tml https://perma.cc/b3jx-xdkx]. 59. brief for biotechnology innovation org. & croplife int’l as amici curiae in support of respondent at 17, impression prods., inc. v. lexmark int’l, inc., 137 s. ct. 1523 (2017) (stating that “[a]ny benefits to u.s. consumers would likely accrue at the expense of poorer consumers elsewhere”). 60. hemel & ouellette, supra note 57, at 25 61. herbert hovenkamp, reasonable patent exhaustion, 35 yale j. on reg. 513, 515-16 2021] a survey of three patent-based approaches 405 under a new definition of patent exhaustion, in a drug context, pharmaceutical companies may be left with few appealing options. in theory, u.s. manufacturers may need to raise prices in foreign markets and lower prices in u.s. markets under a rule of international exhaustion. in other words, the u.s. may need to move toward global prices. “benefits should accrue to u.s. consumers who would pay something between the former u.s. ‘surplus’ price and the adjusted global price, assuming that the pre-international exhaustion price was higher.”62 one possibility for pharmaceutical companies is to evaluate their contracts with distributors “to ensure that those contracts prohibit redistribution into the u.s.,” providing them with a contractual cause of action against the distributor if the distributor were to attempt to import its products back into the u.s.63 another creative approach is to restrict re-importation via license. as pointed out in one editorial by daniel hemel and lisa larrimore ouellette, instead of selling medicines to foreign countries, the pharmaceutical company could “license” the pill to patients on the condition that they either “return the pill or ingest it,” utilizing a principle that is popular in many other industries with this issue.64 further, the u.s. patent exhaustion rule still starkly contrasts with the law in other areas of the world. for example, canada’s patent act has no express provisions analogous to the exhaustion doctrine.65 additionally, the world trade organization’s trade related aspects of intellectual property rights allows member nations discretion regarding their own interpretations of the exhaustion doctrine “whether by statute, judicial opinion, or agency regulations.”66 d. legislation addressing drug re-importation & u.s. price controls the post-lexmark blogosphere was active in declaring that the patent exhaustion doctrine would not “throw open the gates for access to cheaper foreign (2018). 62. brief for professor frederick m. abbot as amicus curiae in support of petitioner at 20, impression prods., inc. v. lexmark int’l, inc., 137 s. ct. 1523 (2017). 63. doug robinson, lexmark case: pharma should review distribution networks, pharmaphorum (oct. 9, 2017), https://pharmaphorum.com/views-and-analysis/pharmadistribution-channel-review/ [https://perma.cc/j7gr-tsvd]. 64. daniel hemel & lisa larrimore ouellette, licensing in the shadow of impression products (with lisa larrimore ouellette), medium (may 31, 2017), https://medium.com/whateversource-derived/licensing-in-the-shadow-of-impression-products-with-lisa-larrimore-ouellette9bbf8c350c65 [https://perma.cc/j7tr-4rgg]. 65. olena ivus, ctr. for int’l governance innovation, patent exhaustion in the united states and canada 2 (2018), https://www.cigionline.org/sites/default/files/documents/ paper%20159web.pdf [https://perma.cc/5zpu-n9ac]. 66. lucas brown, intellectual property rights require a balancing act: the exhaustion doctrine and patentee rights vs. consumer protection, wake forest j. bus. & intell. prop. l. 204, 207 (2019). 406 indiana health law review [vol. 18:397 medicines” because section 804 of the fdca, which “directs [the] fda to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from canada,” had never been certified by the secretary of hhs.67 there are a few reasons for this. first, previous hhs guidance estimated that insurance companies, importers, and exporters would take a large portion of the savings that were intended for consumers. also, sanctioning parallel trade could cripple the pharmaceutical industry’s ability to fund research and development (“r&d”) and innovation, which are “paramount to survival” and the costs of which have continued to rise over the past three decades.68 finally, the prospect of health risks seemed too high, meaning that many steps must be taken to ensure that drug re-importation would not increase the risk of harm to the american consumer.69 then, in july of 2019, former hhs secretary alex azar ii proposed a “safe importation action plan” that would begin to eliminate roadblocks to reimporting drugs from foreign countries, such as canada, under two potential pathways, and attempted to address many of these concerns.70 under pathway one, a notice of proposed rulemaking (“nprm”) would rely on section 804 of the fdca “to authorize demonstration projects to allow importation of drugs from canada.”71 section 804 can only be used if the secretary of hhs certifies that importation would impose “no additional risk” to u.s. consumers and that it would “result in a significant reduction in the cost” of those prescription drugs.72 of note, in the sixteen years since its enactment, no secretary has ever given such approval.73 alex azar was also initially opposed.74 67. dennis crouch, demystifying drug importation after impression v. lexmark, patentlyo (june 6, 2017), https://patentlyo.com/patent/2017/06/demystifying-importation-impression.html [https://perma.cc/lhl2-vndq]. 68. jacob arfwedson, inst. for pol’y innovation, re-importation (parallel trade) in pharmaceuticals 6 (2004), https://www.ipi.org/doclib/pr182-paralleltrade.pdfopenelement.pdf [https://perma.cc/tk3d-t3y7]. 69. id. at 25 (“re-importation has been opposed by [ten] of the last [eleven] food and drug administration commissioners since 1969. all cited public safety concerns (including risks of mishandling, mislabeling, improper storage, ineffective product recalls, and expiration date violations). some also expressed concern about the potential for opportunists to manufacture and sell counterfeit drugs.”). 70. safe importation action plan, supra note 11. 71. id. at 1. 72. id. 73. id. 74. alex m. azar ii, secretary, u.s. dep’t of health & hum. servs., remarks on drug pricing blueprint in washington, d.c. (may 14, 2018), https://www.hhs.gov/about/leadership/ secretary/speeches/2018-speeches/remarks-on-drug-pricing-blueprint.html [https://perma.cc/ua9sx6sg] (“[t]he last four fda commissioners have said there is no effective way to ensure drugs coming from canada really are coming from canada, rather than being routed from, say, a counterfeit factory in china. the [u.s.] has the safest regulatory system in the world. the last thing https://perma.cc/lhl2-vndq 2021] a survey of three patent-based approaches 407 demonstration projects, which would “outlin[e] how they import healthcanada approved drugs in compliance with [s]ection 505 of the [fdca],” could be submitted by states, wholesalers, or pharmacists.75 further, there are a number of medications excluded under pathway one: controlled substances, biological products, infused medications, intravenous injected medications, medications inhaled during surgery, certain parenteral medications, and medications associated with risk evaluation and mitigation strategies.76 under pathway two, the drug manufacturers themselves would re-import their own drugs after establishing with the fda that the foreign version is the same as the u.s. version.77 this would allow a pharmaceutical manufacturer to sell a foreign version of a drug product in the u.s. under a unique national drug code number compared to the u.s. version, which would allow the manufacturer, if they desired, to sell the product at a lower price.78 because the manufacturer would be able to import its drug through conventional supply channels, this pathway generally would rely on applicable existing safeguards to ensure supply chain integrity.79 for supporters of importation, there are some potential challenges. proposing a demonstration project, as required for pathway one, that could allow these types of certifications will take extensive resources and time, potentially decreasing savings to the consumer.80 because pathway one is also subject to the formal rulemaking process, which includes a required notice and comment period, this process could take several years before interested parties could begin submitting plans for demonstration projects.81 further, there are restrictions on the types of medicines that may be imported through this pathway, and it excludes some of the more expensive categories of drugs (e.g., biologics, such as insulin).82 some of the groups eligible to use this pathway, such as pharmacy groups, oppose it because of concerns about patient safety and the desire to preserve their relationship with patients, “particularly for vulnerable patients with complex medication regimens.”83 next, section 804 of the fdca can only become effective if the secretary of hhs certifies that its “implementation . . . will pose no additional risk to the we need is to open borders for unsafe drugs in search of savings that cannot be safely achieved.”). 75. safe importation action plan, supra note 11. 76. id. at 3. 77. id. 78. id. 79. id. 80. benjamin m. zegarelli, in policy reversal, hhs and fda propose plan to import foreign drugs, mintz (aug. 8, 2019), https://www.mintz.com/insights-center/viewpoints/2791/ 2019-08-policy-reversal-hhs-and-fda-propose-plan-import-foreign [https://perma.cc/3cdc-ezlj]. 81. id. 82. id. 83. issue brief: safe importation action plan, am. soc’y health-system pharmacists, https://www.ashp.org/advocacy-and-issues/key-issues/drug-pricing/issue-brief-safe-importationaction-plan [https://perma.cc/gep6-aslf] (last visited mar. 14, 2021). 408 indiana health law review [vol. 18:397 public’s health and safety and will result in a significant reduction in the cost of covered products to the american consumer.”84 however, since the passage of the medicare modernization act in 2003, “no subsequent hhs secretary, republican or democrat,” has been willing to certify that they are safe.85 however, secretary azar is not planning to make that broad of a certification. instead, he will “propose to condition certification on the ability to limit the program to demonstration projects under [s]ection 804(b)-(h) and would seek comments on that proposal.”86 “it is not clear that the secretary has the legal authority to make a ‘conditional’ certification that is far short of the complete certification required by statute.”87 second, hhs is proposing to include “states” as sponsors of demonstration projects.88 unfortunately, “states” are not authorized importers under the law. for example, “[t]he secretary, after consultation with the [u.s.] trade representative and the commissioner of u.s. customs and border protection, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from canada into the [u.s.].”89 thus, it is unclear whether hhs could authorize a demonstration project from any of the states. pathway two has a significant advantage for u.s. consumers because “[i]t would apply to any ‘versions of fda-approved drug products’ that a manufacturer sells abroad.”90 this includes, for example, generic versions that are sometimes produced, or authorized to be produced, by pharmaceutical manufacturers themselves.91 phrma and bio, industry trade groups that often represent the voice of pharmaceutical manufacturers, have spoken in opposition to pathway two, making it “reasonable to expect that most manufacturers may choose to ignore [it].”92 further, canada tends to be generally opposed due to concerns about their own drug supply: “[a] recent study estimates that the entire canadian drug supply would be exhausted in 183 days if only 20% of u.s. prescriptions were filled 84. safe importation action plan, supra note 11; see generally medicare prescription drug, improvement, and modernization act of 2003, pub. l. no. 108-173, 117 stat. 2066. 85. merrill matthews, vermont’s prescription for failure, inst. pol’y innovation (may 22, 2018), https://www.ipi.org/ipi_issues/detail/vermonts-prescription-for-failure [https://perma. cc/br4d-292t] (providing the oppositions of secretary donna shalala, secretary tommy thompson, commissioner andrew c. von eschenbach, and commissioner margaret hamburg). 86. safe importation action plan, supra note 11. 87. a gimmick no more? hhs moves to authorize prescription drug importation, king & spaulding (aug. 6. 2019), https://www.kslaw.com/news-and-insights/a-gimmick-no-more-hhsmoves-to-authorize-prescription-drug-importation#_edn13https://www.kslaw.com/news-andinsights/a-gimmick-no-more-hhs-moves-to-authorize-prescription-drug-importation#_edn13 [https://perma.cc/fhm7-eklz] [hereinafter king & spaulding]. 88. safe importation action plan, supra note 11. 89. 21 u.s.c. § 384 (2020) (emphasis added). 90. king & spaulding, supra note 87. 91. zegarelli, supra note 80. 92. id. 2021] a survey of three patent-based approaches 409 using canadian prescription drug sources.”93 in the past, plans to import drugs from canada had been met with resistance from the u.s. over concerns about drug safety and the introduction of counterfeit drugs into the u.s. drug supply.94 but, as drug prices in the u.s. have risen, the idea has gained support. states, including florida, maine, colorado, and vermont, have passed laws to allow imports, subject to the approval of hhs.95 ‘“this is going to exacerbate some of the drug shortages that [we are] already seeing in canada,’ said joelle walker, the vice president of public affairs for the canadian pharmacists association. ‘we [are not] equipped to deal with a country that is ten times our size.’”96 further, pharmaceutical companies, although they partner with government research and academia, are largely responsible for developing new medicines, which is an expensive process that can take many years.97 consequently, r&d expenditure is much greater than that of either government or academia. as an example, the r&d expenditure of pharmaceutical companies was nearly triple the national institutes of health’s r&d expenditure in 2017, the budget of which does not go entirely to drug development research.98 if a pharmaceutical manufacturer’s profitability is reduced, they may choose to invest fewer dollars in r&d and could “shift their focus from very high-cost biological drugs for rare diseases back to more reasonably priced drugs for more common diseases.”99 as with all things, “[t]he system will be better for some and worse for others.”100 iii. patent thicketing patent thicketing is a patent strategy with origins outside of the 93. c. michael white, cheaper drugs from canada likely won’t cure what ails us, ct mirror (oct. 4, 2019), https://ctmirror.org/category/ct-viewpoints/why-cheaper-drugs-fromcanada-likely-wont-cure-what-ails-us/ [https://perma.cc/3j78-795n]; see allison martell, exclusive: canada warns u.s. against drug import plans, citing shortage concerns, reuters (july 18, 2019), https://www.reuters.com/article/us-canada-pharmaceuticals-exports-exclus/ exclusive-canada-warns-us-against-drug-import-plans-citing-shortage-concerns-iduskcn1ud2ln [https://perma.cc/x9h4-fl4b] 94. white, supra note 93. 95. findlay, supra note 31. 96. amanda coletta, trump and sanders want to ease imports of drugs from canada. canada says not so fast, wash. post (aug. 1, 2019), https://www.washingtonpost.com/world/ the_americas/trump-and-sanders-want-to-ease-imports-of-drugs-from-canada-canada-says-not-sofast/2019/08/01/1f0f91a6-b463-11e9-acc8-1d847bacca73_story.html [https://perma.cc/84f3-9zl3]. 97. andrew powaleny, ip explained: understanding biopharmaceutical innovation, catalyst (july 30, 2019), https://catalyst.phrma.org/ip-explained-understanding-biopharma ceutical-innovation [https://perma.cc/59ta-9q7v]. 98. id. 99. white, supra note 93. 100. id. 410 indiana health law review [vol. 18:397 pharmaceutical drug industry and is used to describe a practice allegedly intended to extend the patent life of a product by protecting said product with as many patents as possible.101 despite the fact that thicketing is prominent in crowded industries like computer software,102 examples are also present in the pharmaceutical industry. this certainly is not intended to imply that pharmaceutical innovation is not happening – the center for drug evaluation and research approved forty-eight “novel drugs” in 2019, twenty of which were “first in class.”103 in fact, cumulative innovation is often considered the essence of science.104 “as sir isaac newton put it, each scientist ‘stands on the shoulders of giants’ to reach new heights.”105 however, while the practice of patenting incremental innovations is common, even necessary, it has gained notoriety in the public eye. medications, like humira (adalimumab), have received public scrutiny for the disproportionate numbers of patents that are obtained to retain market exclusivity decades beyond their original date of introduction. humira is currently the best-selling prescription drug in the world.106 it is the single largest revenue source for abbvie, with sales of over $20 billion in 2018 alone.107 in december 2016, humira’s composition of matter patent expired.108 however, companies with fda-approved biosimilars (e.g., amgen, boehringer ingelheim, and novartis) have not been able to enter the market and have instead reached deals with abbvie to delay their products’ market entry until 2023.109 this was done because the company now holds approximately 136 humira patents.110 of these, the uspto has granted the company more than [thirty] patents on the ways in which the drug is administered; more than [twenty-five] patents on various formulations of the drug; more than [fifty] patents related to humira’s manufacturing processes; and about [twenty] patents on the delivery 101. carl shapiro, navigating the patent thicket: cross licenses, patent pools, and standard setting, 1 innovation pol’y & econ. 119, 119-21 (2001). 102. id. 103. novel drug approvals for 2019, food & drug admin., https://www.fda.gov/drugs/newdrugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drugapprovals-2019 [https://perma.cc/cts9-ftfb] (last updated jan. 14, 2020). 104. shapiro, supra note 101, at 119 105. id. at 119-20. 106. sy mukherjee, protect at all costs: how the maker of the world’s bestselling drug keeps prices sky-high, fortune (july 18, 2019), https://fortune.com/longform/abbvie-humiradrug-costs-innovation/ [https://perma.cc/aq5f-wbhc]. 107. id. 108. id. 109. id. 110. id. 2021] a survey of three patent-based approaches 411 devices that customers use to take the medicine.111 notably, a discovery order from a case between boehringer ingelheim international gmbh (“bi”) and abbvie shows a court acknowledging that it remains unclear whether there is anything improper about filing a large number of patents.112 further, “[m]any of abbvie’s patents claim priority back to original patent applications filed in 2000 or 2001, before the drug went on sale.”113 therefore, part of the reason that there was a large number of patents granted later is the result of a series of continuing applications that were filed at once, which is a common patent tactic.114 in may of 2019, abbvie resolved its suit with bi.115 abbvie fiercely defended its patent strategy, stating that the “allegations in the lawsuit [were] without merit.”116 despite the fact that each patent is, in fact, received through legal means, the principle is quite unpopular in the public eye.117 in july 2018, fda commissioner scott gottlieb lamented that competition for biosimilars in the u.s. is “anemic,” and he specifically called out the case as being patent litigation due to patent thickets.118 because these alleged patent thickets generally adhere to current patent laws, legislators have attempted to introduce legislation to define and address patent thicketing. currently, there is one major piece of legislation addressing patent thicketing. the affordable prescriptions for patients act was introduced in the u.s. senate on may 9, 2019, by u.s. senators john cornyn and richard blumenthal to prevent thicketing or risk of being sued by the federal trade commission (“ftc”).119 this could happen to pharmaceutical manufacturers if they use tactics like obtaining duplicative patents in order to delay generic 111. id. 112. see abbvie inc. v. boehringer ingelheim int’l gmbh, no. 17-cv-01065-msg-rl, 2019 u.s. dist. lexis 28950, at *7-8 (d. del. feb. 25, 2019). 113. zachary silbersher, did abbvie create a wrongful “patent thicket” around humira®?, markman advisors (aug. 27, 2018), https://www.markmanadvisors.com/blog/2018/8/27/didabbvie-create-a-wrongful-patent-thicket-around-humira [https://perma.cc/mh7a-27t3]. 114. id. 115. press release, abbvie inc., abbvie resolves humira® (adalimumab) u.s. patent litigation with boehringer ingelheim (may 14, 2019), https://news.abbvie.com/news/pressreleases/abbvie-resolves-humira-adalimumab-us-patent-litigation-with-boehringer-ingelheim.htm [https://perma.cc/r4xn-vxcs]. 116. mukherjee, supra note 106. 117. id. (describing how new york law school professor jacob sherkow believes that abbvie is “just taking advantage of existing law”). 118. silbersher, supra note 113. 119. susannah luthi & sarah owermohle, ‘patent thicket’ bill caught in tug-of-war over drug pricing reforms, politico (oct. 25, 2019), https://www.politico.com/news/2019/10/25/ patent-thicket-bill-caught-in-tug-of-war-over-drug-pricing-reforms-056858 [https://perma.cc/9n7rjldf]. 412 indiana health law review [vol. 18:397 versions of the medication from market entry.120 on the other hand, industry group phrma disagrees with the presumption of guilt that the bill places on the manufacturer, saying it would create “a presumption of anti-trust violation for almost any post-approval innovation.”121 vi. product hopping product hopping refers to an alleged practice in which a pharmaceutical company purportedly replaces prescription drugs that are already on the market with slightly modified versions that have the same active pharmaceutical ingredient. the fdca requires fda approval before any drug may be marketed.122 generic manufacturers must submit an “abbreviated new drug application” to show only that their generic product is the bioequivalent to an already approved “reference” drug.123 if the generic product is the branded medication’s bioequivalent and the two are the same dosage, strength, and form, the fda identifies the generic product as the branded version’s “ab-rated” equivalent.124 at the pharmacy, the generic product can then be substituted for the branded medication, which is usually less expensive than the branded version.125 there are two ways a pharmaceutical manufacturer can use the ab-rating necessity to their advantage. the first is through a practice called a “hard switch,” in which a pharmaceutical company purportedly takes a prescription drug completely off the market.126 this would allegedly create a forced-switch because generic substitution is not possible if the branded medication is no longer available.127 the second so-called product hopping scenario is called a “soft switch,” in which the pharmaceutical company allegedly leaves the original drug on the market, though a similar outcome results.128 a. hard switches a famous example of a so-called hard switch is the case of new york ex rel. schneiderman v. actavis plc, in which the branded company actavis sought to replace its twice-daily dosage of the memantine molecule (namenda ir) with an extended-release, once-daily version (namenda xr).129 actavis allegedly began 120. id. 121. id. 122. see 21 u.s.c. § 355 (2020). 123. jessie chang, an antitrust analysis of product hopping in the pharmaceutical industry, 108 colum. l. rev. 1471, 1479 (2008). 124. 21 u.s.c. § 355. 125. chang, supra note 123, at 1479. 126. see, e.g., new york ex rel. schneiderman v. actavis plc, 787 f.3d 638, 647-49 (2d cir. 2015). 127. id. at 642. 128. michael a. carrier & steve d. shadowen, product hopping: a new framework, 92 n.d.l. rev. 167, 168 (2016). 129. see, e.g., actavis, 787 f.3d. at 638. 2021] a survey of three patent-based approaches 413 marketing namenda xr to its patients and made use of rebates to offer it at a low price, a process believed to be a “soft switch.”130 the purported reason for this was that namenda xr was covered by multiple patents that would expire almost fifteen years after the patents that covered namenda ir.131 then, nine months before patents for namenda ir expired, actavis sought to remove it from the market.132 this was purportedly the “hard switch.”133 the new york state attorney general sued actavis under antitrust laws, and the trial court granted its request for a preliminary injunction.134 the court of appeals for the second circuit affirmed, ruling that actavis had to keep namenda ir on the market for thirty days after the generic would first be available.135 interestingly, the holding in actavis contrasts with the outcome in mylan pharmaceuticals inc. v. warner chilcott public limited company.136 mylan, the generic company, sued warner chilcott, the drug manufacturer, alleging a number of product-hopping complaints about its product doryx.137 the court found that warner chilcott “made four critical changes to doryx, all of which required generics to apply for ab-rating if they wanted to continue to benefit from state substitution laws.”138 however, the court “held that mylan failed to muster sufficient evidence of defendant’s monopoly power.”139 warner chilcott public limited company’s (“warner chilcott”) market share “was – at most – only about 18%, an amount insufficient to show that [it] exercised monopoly power.”140 thus, warner chilcott was said not to be engaging in a hard switch product hopping. b. soft switches a so-called soft switch is when the old drug is kept on the market, and it can also allegedly have significant drug price implications. in a soft-switch situation, the original drug stays on the market, allowing the consumer a choice, but the process imparts what is known as a “price disconnect,” meaning the general market balance between price and quality is disrupted because the doctor 130. see pharmaceutical antitrust update: courts address how and when product hopping may violate the antitrust laws, haug partners (mar. 29, 2017), https://www.haugpartners. com/article/pharmaceutical-antitrust-update-courts-address-how-and-when-product-hopping-mayviolate-the-antirust-laws/ [https://perma.cc/w4zv-gcmj]. 131. id. 132. id. 133. id. 134. actavis, 787 f.3d. at 649. 135. id. 136. see mylan pharm. inc. v. warner chilcott pub. co., 838 f.3d 421 (3d cir. 2016). 137. see id. 138. id. at 430. 139. id. at 431. 140. id. 414 indiana health law review [vol. 18:397 prescribing the medication is not the same person or entity paying for it.141 therefore, as one court explained in an ongoing antitrust product hopping case, “the ordinary market forces that would allow consumers to consider price when selecting a product are derailed.”142 therefore, a pharmaceutical company that removes or disparages its original product for the alleged sole purpose of transitioning patients to a newer and higher-priced product may be viewed as anti-competitive.143 numerous pieces of legislation are currently attempting to address product hopping. the affordable prescriptions for patients act would address product hopping in addition to its sections regarding patent thicketing.144 the bill would define product hopping as anti-competitive behavior, thereby allowing the ftc to “bring antitrust suits against bad actors who deliberately game the system, and would give them injunctive authority to make the system fairer and operate as congress intended.”145 the affordable prescriptions for patients through promoting competition act of 2019 was introduced in the house on september 19, 2019, by congressman cicilline.146 the bill was designed to “prohibit [anti-competitive] behaviors by drug product manufacturers, and for other purposes.”147 also, it specifically prohibits product hopping.148 the most common tool to combat product hopping has been to sue pharmaceutical manufacturers under antitrust laws.149 on the other hand, because product hopping nearly always involves medication improvements with benefits to patients, some argue that it should be generally viewed as lawful because anything else would chill innovation.150 whether and how this trade-off should be managed as a matter of regulatory or competition policy is an important question that has yet to be adequately resolved. 141. carrier & shadowen, supra note 128, at 179. 142. in re suboxone (buprenorphine hydrochloride and naloxone) antitrust litig., 64 f. supp. 3d 665, 684 (e.d. pa. 2014). 143. id. 144. affordable prescriptions for patients act introduced in the senate, goodwin l. (may 15, 2019), https://www.goodwinlaw.com/publications/2019/05/affordable-prescriptions-forpatients-act-introduc [https://perma.cc/zm4a-wgjf]. 145. id. 146. cicilline introduces bill to drive down costs of prescription drugs, congressman david cicilline (sept. 19, 2019), https://cicilline.house.gov/press-release/cicilline-introduces-billdrive-down-costs-prescription-drugs [https://perma/h7nh-lwta]. 147. see h.r. 4398, 116th cong. (2019). 148. id. 149. arti k. rai & barak d. richman, a preferable path for thwarting pharmaceutical product hopping, health aff. (may 22, 2018), https://www.healthaffairs.org/do/10.1377/ hblog20180522.408497/full/ [https://perma.cc/3vpu-4xeh]. 150. carrier & shadowen, supra note 128, at 200. 2021] a survey of three patent-based approaches 415 v. conclusion there are several proposed congressional reforms to address drug prices that would modify the existing legal structure of ip rights in the context of pharmaceutical drugs.151 because patents provide incentives for innovation, ip reforms are a matter of public policy that must find a “balance between providing incentives to create innovative new medicines versus the costs those incentives may impose on the public.”152 the costs associated with developing a new prescription drug are enormous, with conservative estimates of the cost to develop a new medicine estimated to be somewhere between $500 million to $1 billion.153 therefore, the patent exclusivity that the pharmaceutical manufacturer receives, which is twenty years from the date on which the application for the patent was filed, is a valuable incentive.154 however, that sounds better than it is. in actuality, by the time most new drugs are approved, the patents covering the medicine often have less than twelve years remaining of the patent term “due to the years required for development, clinical studies, and regulatory review.”155 despite this, many people feel that their prescription drug prices are too high, with one survey finding that nearly 23% of americans have been unable to afford their medications in the past year.156 a. patent exhaustion the development of an exhaustion doctrine forces policymakers to seek a balance between protecting consumer well-being and providing economic incentives for innovators. while a strong exhaustion doctrine, as proposed in lexmark, empowers consumers and limits the ability of patent owners to control the post-sale conduct of purchasers, it also can have the effect of deterring innovation, as a patent owner may not “reap the expected fruits of his or her labor.”157 while blogs, scholars, and courts have weighed in on the doctrine, the reality is that, at the current time, “the impact of re-importation is not clear cut enough to confidently make policy recommendations on economic grounds.”158 therefore, only time will tell how the impact of the lexmark decision, coupled with the “safe importation action plan” and the behaviors of motivated actors, may affect drug prices. 151. hickey et al., supra note 2, at 4. 152. id. at 51. 153. o’connor, supra note 6. 154. id. 155. id. 156. dan witters, millions in u.s. lost someone who couldn’t afford treatment, gallup (nov. 12, 2019), https://www.csrxp.org/icymi-gallup-finds-nearly-58-million-americans-unable-toafford-their-prescription-drugs-up-four-percent-from-january/ [https://perma.cc/quq8-s5fu]. 157. brown, supra note 66, at 208. 158. arfwedson, supra note 68, at 20. 416 indiana health law review [vol. 18:397 b. patent thicketing proposed legislation like the affordable prescriptions for patients act would attempt to prevent patent thicketing by allowing the ftc to challenge the practice as anti-competitive and to enable the ftc to bring antitrust suits against pharmaceutical manufacturers.159 while the proposed legislation states that manufacturers will be allowed to argue that their actions are not anti-competitive by submitting rebuttal evidence,160 the situation remains that, even in the most extreme cases of alleged thicketing, the patents were obtained lawfully by the uspto. therefore, while this legislation may lower drug prices, it also may have a more significant impact on how patents are granted generally by the uspto or how innovators approach bringing these new ideas to the market generally. c. product hopping while the practice of so-called “product hopping” may not be easy to recognize, this practice can result in “monopoly pricing, burdening patients, the government, and the health care system as a whole.”161 product hopping raises issues that intersect with multiple areas of the law: patent, antitrust, and state drug product substitution laws, for example.162 it is particularly complicated due to the unique market forces and pricing disconnect surrounding pharmaceuticals. bills such as the affordable prescriptions for patients act and the affordable prescriptions for patients through promoting price competition act of 2019 aim to curb anti-competitive product hops but must do so cautiously as these efforts could easily prevent legitimate product advances.163 159. senate bill seeks to give ftc authority to fight patent thickets, product hopping, ctr. for biosimilars (may 15, 2019), https://www.centerforbiosimilars.com/news/senate-bill-seeks-togive-ftc-authority-to-fight-patent-thickets-product-hopping [https://perma.cc/k8km-gx9a]. 160. id. 161. michael carrier & steve shadowen, pharmaceutical product hopping: a proposed framework for antitrust analysis, health aff. (june 1, 2017), https://www.healthaffairs.org/ do/10.1377/hblog20170601.060360/full/ [https://perma.cc/y4f7-ahpy]. 162. id. 163. id. https://perma.cc/k8km-gx9a the splintered mind and path to a healed society:* the state of indiana should mandate cognitive behavioral therapy for domestic violence batterers nermy j. winner** i. introduction domestic violence is a continuous pattern where one partner in an intimate relationship tries to assert control and dominance over the other partner.1 unfortunately, although domestic violence continues to put victims, children, and our society in danger; current intervention and rehabilitation efforts are not effective at mitigating such danger. this note discusses the effectiveness of the current batterer intervention methods, specifically the duluth model, used by the state of indiana and surrounding states to reduce domestic violence incidences and recidivism rates. this note also highlights the reasons why indiana should mandate domestic violence batterers to engage in cognitive behavioral therapy (“cbt”) and reassess the effectiveness and use of the duluth model. while cbt contains different models that can be tailored to each person based on their history and experiences, the duluth model uses a one-size-fits-all curriculum in an attempt to solve a deeply rooted issue by criticizing and shaming the act, and the batterer. this note further discusses the impact of covid-19 on domestic violence rates and recidivism, and the urgency of adopting a more uniform, effective mode. ii. the issue many states across america use intervention methods to support victims and children of domestic violence. there are also intervention methods that aim to rehabilitate batterers. however, despite all the efforts taken by states to combat domestic violence, current intervention methods are not effective at decreasing domestic violence rates and domestic violence recidivism. in 2018, twenty percent of all violent crimes were domestic violence crimes.2 also, in 2017, sixty percent of offenders recidivated after being sentenced for a domestic violence * the title of this note is inspired by the idea that a batterer’s mind is not unfixable and is merely splintered. splinters cause no further harm once removed and, thus, there is hope for positive change towards ending domestic violence. ** j.d. candidate, 2023, indiana university – robert h. mckinney school of law; m.s. – clinical psychology, 2018, walden university; b.s. – criminal justice, 2016, indiana university – purdue university indianapolis. 1. domestic violence – what exactly is it?, domestic violence, https://domesticviolence. org/definition/ [https://perma.cc/tg8c-e2kg] (last visited nov. 8, 2021). 2. state-by-state statistics on domestic violence, nat’l coal. against domestic violence, https://ncadv.org/state-by-state [https://perma.cc/e5wn-flvy] (last visited oct. 15, 2021). 174 indiana health law review [vol. 20:173 offense.3 studies suggest that there is significant uncertainty in the efficacy of batterer intervention programs (“bips”).4 further, evidence suggests a large percentage of perpetrators of domestic violence reoffend, despite participation in batterer intervention programs.5 this note includes three parts. the first part discusses the issue of domestic violence, including the history of domestic violence, statistics of domestic violence incidents, the issue of failure to report domestic violence abuse, risk factors contributing to domestic violence, the role of healthcare providers in identifying domestic violence, the effects of domestic violence on children, and the domestic violence cycle. the second part will discuss how the law has viewed and treated domestic violence over the years, domestic violence recidivism rates, the different intervention programs used by different states, specifically, background information and research on the duluth model and cbt, and the impact of covid-19 on domestic violence incident and recidivism rates. the final part of this note examines and analyzes the differences between the duluth model and cbt. it also highlights why cbt is the more effective method in ending the domestic violence cycle and reducing recidivism, the future of cbt in treating domestic violence batterers, a hypothetical statute adopting cbt as a uniform intervention method, and the advantages and disadvantages to using cbt. iii. background domestic violence includes the acts of physical abuse, sexual abuse, emotional abuse, and economic abuse.6 in the united states, 20 people per minute are physically abused by an intimate partner.7 this equals 10 million abused men and women per year.8 almost one out of five murder victims in the united states were killed by an intimate partner.9 approximately 3.2 million children in the united states each year witness violence against their mother or female 3. domestic violence in indiana: 2017 offender overview, ind. crim. just. inst. (mar. 2020), https://secure.in.gov/cji/grant-opportunities/files/domestic-violence-in-indiana-2017offender-overview_march-2020.pdf [https://perma.cc/5q42-3zwr]. 4. maura a. shader-morrissey, batterer intervention program facilitators’ perceptions of the efficacy of current behavior intervention models, smith coll. (2013), https:// scholarworks.smith.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1683&context=theses [https://perma.cc/xrf7-znqy]. 5. id. 6. domestic violence – what exactly is it?, supra note 1. 7. domestic violence national statistics, nat’l coal. against domestic violence, https://www.ncadv.org/statistics [https://perma.cc/db5g-tuka] (last visited oct. 17, 2021). 8. id. 9. homicide and injury from domestic violence, domestic shelters (jan 07, 2015), https://www.domesticshelters.org/articles/statistics/homicide-and-injury-from-domestic-violence [https://perma.cc/e3xs-aacm]. 2023] the splintered mind and path to a healed society 175 caretaker.10 according to the national center on family homelessness, 50% of homeless women reported domestic violence being the main reason for their homelessness.11 unfortunately, despite the ever-increasing rates of domestic violence incidents, many incidents go unreported. victims are often afraid to report their violent partner out of fear of losing their home, kids, or even death.12 abusers often manipulate victims into believing that no one will believe them, and this leaves the victims in fear of serious injury or death if they retaliate against their partner and receive no help.13 further, domestic violence does not always end when the victim escapes or attempts to end the relationship.14 victims are in the most danger in the relationship immediately after trying to escape or seek help.15 in fact, one of every five victims who obtain a restraining order against their abusers are murdered within two days, and one of every three victims are murdered within the first month after obtaining the order.16 the duluth model is a batterer intervention program that has been around for over 40 years and is used by many states to address domestic violence.17 however, studies have shown that programs that use duluth-like models had no effect on recidivism.18 on the other hand, research has shown that programs that used different methods reduced domestic violence recidivism by 33 percent on average.19 the state of indiana uses a duluth-like, curriculum-based program that refrains from focusing on the participant’s individual assessment or treatment plan.20 10. melissa stiles, witnessing domestic violence: the effect on children (dec. 1, 2002), 66 am. family physician 11, https://www.aafp.org/afp/2002/1201/p2052.html#:~:text=potential% 20effects%20in%20children%20who%20witness%20violence%2a%20,of%20physical%20i njury%20%2012%20more%20rows%20 [https://perma.cc/aw9v-m2md]. 11. domestic violence and homelessness, nat’l coal. for the homeless, http://www. nationalhomeless.org/publications/facts/domestic.html [https://perma.cc/96zs-n49t] (last visited sept. 17, 2022). 12. why don’t they report? domestic violence, s. ill. u. med. (aug. 7, 2017), https://www.siumed.org/pr/highlights/why-don’t-they-report-domestic-violence.html [https://perma.cc/3xmw-9z79]. 13. id. 14. learn more, nat’l coal. against domestic violence, https://ncadv.org/learn-more [https://perma.cc/jj3s-v36z] (last visited nov. 8, 2021). 15. id. 16. id. 17. marna miller et al., what works to reduce recidivism by domestic violence offenders?, wash. stat. inst. pub. pol’y. 1, 2 (jan. 2013), https://www.wsipp.wa.gov/reportfile/1119/ wsipp_what-works-to-reduce-recidivism-by-domestic-violence-offenders_full-report.pdf [https://perma.cc/5xax-udts]. 18. id. at 6. 19. id. 20. domestic violence batterers intervention services, ind. dept. child. serv., 176 indiana health law review [vol. 20:173 according to the indiana coalition against domestic violence, a batterers’ intervention program (bip) is an "education-based program that makes victim safety its primary priority, holds offenders accountable, and promotes a coordinated community response to domestic violence."21 while this program is not called the duluth model, its characteristics are very similar. indiana's bip does not take a person's history into consideration22 and is not science based.23 finally, despite the efforts taken by the state of indiana to end domestic violence, in 2020, there was an increase of 181 percent in fatalities over the previous year which were caused by domestic violence incidents.24 this raises the questions of what can be done to effectively rehabilitate batterers, treat victims, and reduce the domestic violence recidivism rate. a. domestic violence 1. history of domestic violence the way domestic violence is viewed changed throughout the years. a man’s right to use violence on his partner to manage the household was legally protected and socially condoned until the late nineteenth century.25 because domestic violence was legally and socially accepted, early efforts at legal reform were limited.26 the main focus was to preserve the family structure rather than protecting the victims of violence.27 in 1910, the supreme court in thompson v. thompson held that “relation between husband and wife was not so far modified as to give the wife a right of action to recover damages from her husband for an assault and battery committed by him upon her person. . .”28 however, the feminist movement of the 1960s and 1970s drew attention to the problem of domestic violence.29 as a result, in 1970, the united states https://www.in.gov/dcs/files/14-batterers-intervention.pdf [https://perma.cc/xz3p-xkje] (last visited jan. 17, 2021). 21. batterers’ intervention programs, ind. coal. against domestic violence, https://icadvinc.org/batterers-intervention-programs/ [https://perma.cc/elk6-kpnb] (last visited oct. 19, 2021). 22. id. 23. id. 24. domestic violence fatality review report 2020-21, ind. coal. against domestic violence (2021), https://icadvinc.org/wpcontent/uploads/2021/10/fatalityinfographic_final.pdf [https://perma.cc/3d9t-rau3]. 25. new state and federal responses to domestic violence, 106 harv. l. rev. 1528, 153031 (1993). 26. id. at 1530. 27. id. 28. thompson v. thompson, 218 u.s. 611, 615 (1910). 29. amanda dekki, punishment or rehabilitation? the case for state-mandated guidelines for batterer intervention programs in domestic violence cases, 18 st. john’s j. legal comment. 549, 554 (2004). 2023] the splintered mind and path to a healed society 177 government began making efforts to end domestic violence by assisting individual victims with legal aid, counseling, job opportunities, and emergency shelters.30 in the 1980s, more changes were taking effect regarding the legal response to domestic violence, including specialized domestic violence courts, batterer intervention programs, stalking statutes, and better arrest policies.31 further, programs focusing on aiding the victims mentally, emotionally, and financially were being implemented.32 finally, in 1989, in catlett v. catlett, the court decided that a $20,000 award of punitive damages was appropriate for a wife who provided sufficient evidence that her injuries resulted from assault, battery, and false imprisonment by her husband.33 the court’s decision in catlett showed that courts began recognizing domestic violence as a crime and not a private family matter. by 2010, courts were taking serious actions to protect domestic violence victims. for example, in wolt v. wolt, the supreme court of north dakota issued a protection order restraining a former husband from contact with the former wife for two years.34 wolt was a major milestone for domestic violence reform because there, the court issued a protective order against a batterer solely for inflicting fear and not for actual physical harm. the court based its decision on the evidence presented, which showed that the former husband inflicted fear of imminent physical harm upon the former wife.35 the law continues to change to provide more protection to domestic violence victims. 2. the cycle of domestic violence to recognize the importance of effective rehabilitation for domestic violence, one must first understand the components that make up the domestic violence cycle. breaking the cycle of domestic violence and abuse is difficult and may seem impossible.36 the domestic abuse cycle begins with the tension-building phase. this phase is when abusers’ anger begins to build up.37 during the tensionbuilding phase, the abuser often threatens the victim, and the victim becomes compliant and does everything to please and not upset the abuser.38 the second step in the cycle is the abusive incident, this incident is not 30. id. 31. id. 32. id. 33. catlett v. catlett, 388 s.e.2d 14, 15 (ga. ct. app. 1989). 34. wolt v. wolt, 778 n.w.2d 786, 788 (n.d. 2010). 35. id. at 790. 36. grace j. humbles, breaking the cycle, healthscope, https://healthscopemag.com/ health-scope/breaking-the-cycle/#:~:text=breaking%20the%20cycle%20of%20abuse%20is% 20extremely%20difficult,the%20powerful%20control%20your%20abuser%20has%20over%20you [https://perma.cc/fve5-x7xg] (last visited nov. 8, 2021). 37. id. 38. id. 178 indiana health law review [vol. 20:173 always an incident of physical violence. other forms of abuse include stalking, neglect, psychological, emotional, economical, and sexual abuse.39 the incident occurs when the abuser can no longer control his anger and lashes out on the victim.40 this releases anger and temporarily reduces the tension.41 the last step in the cycle is the honeymoon or calm phase. this phase occurs when the abuser feels guilty for his actions and offers the victim an apology, gifts, and promises to change.42 unfortunately, once the honeymoon phase is over, the tension-building phase begins again, and the promises the abuser made to the victim are broken, causing the cycle to repeat itself.43 this cycle repetition leaves the victim trapped in a cycle of abuse, remorse, forgiveness, and continued abuse.44 this cycle not only puts the victim in danger, but children in such environments are also affected by witnessing the abuse and its toxic present.45 despite the promises made by the abuser to the victim that it “will never happen again,” in most cases, the abuser will not change, and the only way to end the abuse is for the victim to end the relationship.46 the most dangerous time in an abusive relationship for the victim is when they try to leave their abuser.47 domestic violence cycles do not end with specific relationships and are likely to continue with the children who grow up in abusive households, as they have a higher chance of becoming abusers themselves.48 in order to protect children and their future, an effective intervention method must be implemented immediately. 3. identification of domestic violence the health care system plays a major role in identifying domestic violence. 49 because nearly all young children and teens are seen in a health care setting, these settings provide an opportunity for health care providers to identify mothers and children living with a violent partner or parent.50 according to betsy mcalister groves, a 2001 study in north carolina found that only 23 percent of 39. jennifer focht et al., the cycle of domestic violence, nat’l center for health research, https://www.center4research.org/the-cycle-of-domestic-violence/ [https://perma. cc/z9wr-dz6g] (last visited mar. 14, 2022). 40. id. 41. humbles, supra note 36. 42. id. 43. focht et al., supra note 39. 44. humbles, supra note 36. 45. id. 46. focht et al., supra note 39. 47. id. 48. humbles, supra note 36. 49. becky mcalister groves et al., identifying and responding to domestic violence, family violence prevention fund 1, 1 (aug. 2004), http://www.futureswithoutviolence.org/ userfiles/file/healthcare/pediatric.pdf [https://perma.cc/qjf6-hhnk]. 50. id. 2023] the splintered mind and path to a healed society 179 women injured by a partner shortly after pregnancy received treatment for their injuries. however, almost all of these women used health care services for their infants, indicating that child health settings are potentially important for identifying intimate partner violence.51 when domestic violence is identified, the health care providers should take several steps: first, the victim should be assured that confidentiality will be maintained.52 the health care provider should avoid expressing outrage towards the perpetrator, make the victim feel responsible for the abuse, or tell the victim to leave the relationship.53 if the mother discloses abuse during a well-child visit, the disclosure should not be in the child’s medical record, since the perpetrator may have access to those records.54 victims of abuse have reported that one of the most important parts in their interaction with their health care provider is being listened to about the abuse.55 moreover, the health care provider can support a victim denying abuse by laying the groundwork for the possibility of future disclosure or discussion of the issue.56 4. factors contributing to domestic violence while children who grow up in violent environments are at a greater risk of becoming violent adults,57 this is not the only cause of domestic violence. several individual, relational, community, and societal factors contribute to the risk of becoming violent in a relationship.58 other factors include ones’ cultural beliefs.59 for example, cultures that support traditional gender norms and gender inequality, and the idea that women should stay home and be submissive, while men should make the decisions and provide for the family,60 encourage men to be violent towards their partner if the partner is not submissive.61 those cultures 51. id. at 7. 52. melissa stiles, witnessing domestic violence: the effect on children, 66 am. family physician 11, 12 (dec. 1, 2002), https://www.aafp.org/afp/2002/1201/p2052.html#:~:text= potential%20effects%20in%20children%20who%20witness%20violence%2a%20,of%20ph ysical%20injury%20%2012%20more%20rows%20 [https://perma.cc/aw9v-m2md]. 53. id. at 6. 54. id. 55. groves et al., supra note 49. 56. id. 57. domestic violence national statistics, nat’l coal. against domestic violence, https://www.ncadv.org/statistics [https://perma.cc/db5g-tuka] (last visited feb. 19, 2022). 58. risk factors for intimate partner violence perpetration, ctr. for disease control prevention (oct. 9, 2020), https://www.cdc.gov/violenceprevention/intimatepartnerviolence/ riskprotectivefactors.html [https://perma.cc/q9bq-rua4]. 59. id. 60. id. 61. contributing factors, rutgers off. violence prevention and victim assistance, http://vpva.rutgers.edu/contributing-factors/ [https://perma.cc/bvc2-rkbv] (last visited nov. 8, 180 indiana health law review [vol. 20:173 encourage the idea that “women are not equal to men.”62 further, boys who grow up with the mentality that they are more superior solely because of their gender tend to become violent towards their female partner when they feel that their partner is not obedient enough, and their superiority as males is being compromised.63 furthermore, individual risk factors for domestic violence perpetration include mental illnesses, substance abuse, financial stress, and low iq or academic achievements.64 moreover, relational risk factors for domestic violence perpetration include witnessing domestic violence between parents as a child, experiencing poor parenting as a child, and history of experiencing physical discipline as a child.65 community and societal risk factors include poverty and cultural norms that support aggressive behavior towards others.66 many families that experience domestic violence struggle with multiple other problems, including poverty, substance abuse, and exposure to other forms of violence.67 it is important to note that while there are many factors that can increase the probability of domestic violence, those factors are not the sole cause for domestic violence. because domestic violence is a learned behavior,68 and all learned behaviors can be replaced by different behaviors, domestic violence and anger can be controlled and replaced by positive behaviors.69 this can be accomplished by learning coping skills, empathy, and how to deal with emotions and conflict in a healthy manner.70 5. effects of domestic violence on children approximately 3.2 million american children witness domestic violence incidents annually.71 being a victim of physical or psychological abuse is consistently one of the strongest predictors of becoming a domestic violence 2021). 62. toby d. goldsmith, what causes domestic violence?, psychcentral (sept. 20, 2021), https://psychcentral.com/lib/what-causes-domestic-violence#1 [https://perma.cc/5gc6-kx2a]. 63. see melissa kathleen oliver, domestic violence: factors, perpetuation, cultural differences & treatment, cal. polytechnic state u., https://digitalcommons.calpoly.edu/cgi/ viewcontent.cgi?article=1028&context=psycdsp [https://perma.cc/bd8n-yux9]. 64. risk factors for intimate partner violence perpetration, supra note 58. 65. id. 66. id. 67. lucy salcido carter et al., domestic violence and children: analysis and recommendations, 9 the future of child. 4 (1999). 68. linda lyons king, domestic violence is learned behavior, goerie (sept. 20, 2014), https://www.goerie.com/article/20140920/news/610192671 [https://perma.cc/6rmr-depg]. 69. jim johnston, can you unlearn a behavior?, talking about behavior (aug. 4, 2016), https://talkingaboutbehavior.com/can-you-unlearn-a-behavior/ [https://perma.cc/9ckw-yatx]. 70. id. 71. stiles, supra note 52. 2023] the splintered mind and path to a healed society 181 perpetrator.72 some children do not witness domestic violence, yet still become violent adults.73 this often occurs because many of these children undergo direct abuse.74 according to the international society for traumatic stress studies, “the word trauma is used to describe negative events that are emotionally painful and that overwhelm a person’s ability to cope.”75 while the most known form of trauma stems from physical or sexual abuse, there are other forms of abuse that are less often discussed. for example, individuals who grow up with overly controlling, narcissistic or emotionally immature parents are often victims of childhood trauma. those types of parents tend to often psychologically abuse their children.76 “psychological abuse includes a range of non-accidental actions that create fear in a child or that intend to injure his or her dignity and psychological integrity.”77 individuals who grow up in homes where their emotions are not acknowledged and validated, and are not heard, seen, or understood by their parents tend to have a negative self-image, which contributes to becoming a violent adult.78 this occurs due to their lack of coping skills, emotional intelligence and ability to effectively communicate their feelings and emotions to their partner and to others.79 an adult who does not possess the basic skills to cope and communicate can become angry and lash out.80 also, growing up in an abusive environment can create resentment, which may manifest itself onto one’s partner.81 moreover, children who are exposed to domestic violence in the home experience emotional, mental, social, and developmental problems.82 children 72. risk factors for intimate partner violence perpetration, supra note 58. 73. id. 74. stiles, supra note 52. 75. childhood trauma, int’l soc’y for traumatic stress stud., https://istss.org/publicresources/trauma-basics/what-is-childhood-trauma [https://perma.cc/p8eh-uvsu] (last visited nov. 8, 2021). 76. ute haring et al., reflecting on childhood and child agency in history, 5 palgrave comm. 1, 1 (2019). 77. what is childhood trauma, justspeak, https://justspeak.org/what-is-childhood-trauma/ [https://perma.cc/kse7-9k58] (last visited sept. 18, 2022). 78. childhood trauma, supra note 75. see also effects of complex trauma, nat’l child. traumatic stress network, https://www.nctsn.org/what-is-child-trauma/trauma-types/complextrauma/effects [https://perma.cc/2ynm-tzrt] (last visited nov. 8, 2021). 79. haring et al., supra note 76. 80. effects of complex trauma, supra note 78. 81. rachael pace, growing up in an abusive home: effects of domestic violence on children, marriage.com, https://www.marriage.com/advice/domestic-violence-and-abuse/effectsof-domestic-violence-on-children/ [https://perma.cc/3l2j-km25] (last updated may 9, 2021). 82. impact on children and youth, child welfare info. gateway, https://www. childwelfare.gov/topics/systemwide/domviolence/impact/children-youth/ [https://perma.cc/g7twbh9e] (last visited oct. 17, 2021). 182 indiana health law review [vol. 20:173 who witness violence in the home lose the ability to have empathy towards others, while others feel socially isolated and unable to make friends due to the confusion and discomfort over which behavior is socially acceptable.83 further, children who witness domestic violence can suffer severe emotional and developmental difficulties that are like those of children who are direct victims of abuse.84 in a domestic violence longitude study, researchers found that children who witnessed domestic violence were more likely to engage in risky, aggressive, and violent behavior as adults.85 domestic violence can have a devastating ripple effect that does not only harm families, but also communities.86 b. domestic violence and the law the law in indiana defines domestic violence according to indiana code section 34-6-2-34.5 as: domestic or family violence, unless it is an act of selfdefense, is committed by a family or a household member attempting or threatening to cause physical harm or placing a family member in fear of physical harm or causing a family member to engage in nonconsensual sexual activity. further, “[a] person who is or has been a victim of domestic or family violence may file a petition for an order of protection against a: (1) family or household member who commits an act of domestic or family violence; or (2) person who has committed stalking under ind. code § 35-45-10-5 or a sex offense under ind. code § 35-42-4 against the petitioner.”87 the term “family or household member” is defined in part as “a person who is dating or has dated,” and “a person who is engaged or was engaged in a sexual relationship.”88 courts in indiana have the discretion to order domestic violence batterers to complete counseling. for example, indiana code § 35-38-2-2.3(a)(4) permits a trial court, as a condition of probation, to require a person to “[p]articipate in a treatment program, educational class, or rehabilitative service. . .”89 further, in skipworth, the court of appeals held that the trial court’s dismissal of the domestic battery charge had no bearing on the trial court’s ability to assess whether domestic violence counseling is necessary as a treatment program.90 batterer intervention programs were founded in the late 1970s with the goal 83. id. 84. id. 85. ericka kimball, edleson revisited: reviewing children’s witnessing of domestic violence 15 years later, j. family violence 625, 626 (2016). 86. caroline newman, the pandemic is increasing intimate partner violence, uab news health & med. (oct. 26, 2021), https://www.uab.edu/news/health/item/12390-the-pandemic-isincreasing-in t imate-partner-violence-here-is-how-health -care-providers-can-help [https://perma.cc/a5qy-seuw]. 87. ind. code § 34-26-5-2(a) (2020). 88. ind. code §§ 34-6-2-44.8(2), (3) (2021). 89. skipworth v. state, 68 n.e.3d 589, 590 (ind. ct. app. 2017) (quoting ind. code § 35-382-2.3(a)(4)). 90. id. at 592. 2023] the splintered mind and path to a healed society 183 of putting an end to domestic violence.91 batterer intervention programs focus on changing the offender’s behavior towards women.92 batterer intervention programs include three approaches; (a) the psychotherapeutic approach, which is mostly aligned with cbt; (b) the family systems model, which focuses on family-based therapy; and (c) the feminist approach, which is what the duluth model follows.93 batterer intervention programs have become a part of every state’s effort to put an end to domestic violence by rehabilitating batterers. indiana defined batterer's intervention programs to be necessary for any person convicted of domestic battery or a crime that involved domestic abuse, neglect, or violence.94 in such cases, a trial court may require the person to complete a batterer's intervention program approved by the court. the state of indiana requires the batterer to pay all expenses of the batterer's intervention program. the state also requires all batterer's intervention programs to be certified by the indiana coalition against domestic violence.95 further, in 1992, the indiana general assembly created the domestic violence prevention and treatment (“dvpt”) grant program to support indiana’s domestic violence centers, to offer domestic violence training for service providers, and to expand services to treat and prevent domestic violence.96 as the state administering agency, the indiana criminal justice institute is responsible for administering dvpt funds.97 other states took similar measures to provide meaningful intervention programs for domestic violence batterers. for example, the state of mississippi defined batterer intervention programs as “a program that focuses on behavior modification for perpetrators of domestic violence to prevent domestic violence from reoccurring. this shall not include programs focusing on anger management or marriage counseling. any batterer intervention program must document cooperation with a domestic violence shelter program.”98 west virginia provided that a “[b]atterer intervention and prevention program,” previously referred to as a program of intervention for perpetrators, means a licensed educational program that provides classes to individuals who commit acts of domestic violence or abuse, offering nonviolent strategies and values that promote respect and equality in intimate partner relationships.99 91. dekki, supra note 29. 92. id. 93. id. 94. ind. code § 34-26-5-2(a) (2020). 95. ind. code § 35-50-9-1 (2021). 96. ind. code § 5-2-6.7 (2020). 97. domestic violence prevention and treatment grant program, ind. crim. just. inst., https://www.in.gov/cji/victim-services/dvpt/ [https://perma.cc/vzy2-7k2p] (last visited nov. 8, 2021). 98. miss. code § 93-21-101 (2018). 99. w. va. code § 48-26-203 (2021). 184 indiana health law review [vol. 20:173 moreover, florida set requirements for a successful batterers’ intervention program, stating that a batterers' intervention program must hold the batterer accountable for acts of domestic violence. the program content shall also be based on a cognitive behavioral therapy model or psychoeducational model that addresses tactics of power and control by one person over another.100 oregon set similar requirements, providing that batterers' intervention programs must address male defendants, female defendants, defendants offending against same-sex victims, and circumstances in which the defendant or victim is gender nonconforming. moreover, requirements must also be based on scientific research and direct practice, both with persons who have perpetrated domestic violence and with persons who have survived domestic violence.101 finally, the family violence prevention and services act (“fvpsa”) was enacted by congress in 1984 for the purpose of authorizing the secretary to implement programs to increase public awareness about and prevent intimate partner violence by: (1) providing immediate shelter and supportive services for victims and their dependents; (2) providing technical assistance and training related to domestic violence programs; (3) providing state domestic violence coalitions; (4) providing specialized services for abused parents and their children; and (5) operating a national domestic violence hotline. fvpsa emphasizes both primary and secondary prevention of violence.102 c. domestic violence recidivism domestic violence recidivism is the re-appearance of the offender, as the subject of complaints and offenses including non-compliance, threats, and physical violence.103 domestic violence offenders tend to have high rates of recidivism.104 three-fifths of individuals convicted of domestic violence are rearrested within two years—and sixty-seven percent of this group are rearrested for another domestic violence offense.105 according to tamika payne, batterer intervention programs have not been proven to have an impact on reducing recidivism in domestic violence cases.106 treatment needs to be tailored based on gender, criminal history, and other relevant factors.107 research shows that 100. fla. stat. § 741.325 (2021). 101. or. rev. stat. § 180.700 (2021). 102. 45 c.f.r. § 1370.1 (2021). 103. viet nguyen & mia bird, tailoring domestic violence programs to reduce recidivism, pub. pol’y inst. cal. (june 12, 2018), https://www.ppic.org/blog/tailoring-domestic-violenceprograms-to-reduce-recidivism/ [https://perma.cc/t8gs-79s7]. 104. id. 105. id. 106. tamika l. payne, domestic violence recidivism: restorative justice intervention programs for first-time domestic violence offenders (june 2017) (ph.d. dissertation, walden university), https://scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=4922&context= dissertations [https://perma.cc/684c-f7df]. 107. nguyen & bird, supra note 103. 2023] the splintered mind and path to a healed society 185 tailoring domestic violence intervention programs based on offenders’ risks and needs could be beneficial in reducing recidivism.108 the results of a natural field experiment conducted to assess the recidivism rate between the duluth model and cbt suggests that the duluth approach has meaningfully higher recidivism rates compared to cbt.109 further, a meta-analysis of domestic violence interventions found little to no impact of the duluth model beyond mandatory arrest and recidivism.110 a study of psychological variables including truthfulness, violence, control, and coping abilities, found no meaningful change in these psychological traits among individuals before and after receiving treatment using the duluth model.111 cbt is one of the more promising rehabilitative treatments for criminal offenders.112 cbt was ranked among one of the top tiers with regard to effects on recidivism based on reviews of different treatment approaches.113 evidence shows that cbt reduces recidivism among youth and adult offenders, and the effects are strongest for those who are at a higher risk of recidivism.114 cbt has been shown to reduce violence and other criminal behavior across populations.115 according to the washington state institute for public policy, every $1.00 spent on delivering cbt to adult offenders yields a savings of $6.31 in avoided criminal justice and associated healthcare costs, with a 97% likelihood that its benefits will exceed the cost of providing the service.116 as summarized by amy barch, “cbt is the most effective research-tested strategy to change criminal behavior.”117 108. id. 109. chad cotti et al., duluth versus cognitive behavioral therapy: a natural field experiment on intimate partner violence diversion programs, 26 j. experimental psychol. applied 384, 384 (oct. 10, 2019), https://pubmed.ncbi.nlm.nih.gov/31599627/ [https://perma.cc/ cbu3-vwp7]. 110. lily gleicher & jacquelyn gilbreath, policies and programs to address individuals who perpetrate intimate partner violence, ill. crim. just. info. (may 11, 2021), https://icjia. illinois.gov/researchhub/articles/policies-and-programs-to-address-individuals-who-perpetrateintimate-partner-violence [https://perma.cc/9sc3-qa49]. 111. id. 112. mark w. lipsey et al., effects of cognitive-behavioral programs for criminal offenders, 6 campbell systematic rev. 1, 4 (2007). 113. id. 114. cognitive-behavioral therapy (cbt) for offenders, cnty. health rankings & roadmaps, https://www.countyhealthrankings.org/take-action-to-improve-health/what-works-forhealth/strategies/cognitive-behavioral-therapy-cbt-for-offenders [https://perma.cc/n8up-cd2n] (last updated mar. 28, 2018). 115. amy barch, a better way to keep people from going back to prison, stan. soc. innovation rev. (jul. 7, 2021), https://ssir.org/articles/entry/a_better_way_to_keep_people_from_ going_back_to_prison [https://perma.cc/44n3-7sq2]. 116. id. 117. id. 186 indiana health law review [vol. 20:173 d. intervention methods 1. the duluth model the duluth model was developed in early 1980s in duluth, minnesota by domestic violence activists ellen pence and michael paymar.118 the belief under this model is that battering is used to intentionally have power over and control the other partner.119 the duluth model aims to create a change by blaming men and “actively works to change societal conditions that support men’s use of tactics of power and control over women.”120 the duluth model uses a one-sizefits-all counseling approach focused only on assault being viewed as a willful exercise of male privilege. batterer intervention programs based on the duluth model ignore important factors related to violence, including substance abuse, stake-in-conformity motivations, personality features of the batterer, relational dynamics within the couple, history of trauma, and the role of shame.121 researchers confirm what common sense dictates: that violence between individuals, while influenced by social and cultural variables, is more parsimoniously explained by an examination of individual characteristics, contexts, and functions of behavior.122 according to greg bohall, because the duluth model was developed by activists, lacks a scientific base, does not require continuing education, has no governing body for practitioners, and is designed to be practiced by paraprofessionals, there is minimal evidence that culturally competent services are being provided to the clients via this model.123 the duluth model favors the simplistic explanation of violence as the patriarchal view of the male needing to establish power and control.124 this narrow focus that the duluth model is based on ignores the source of the issue and does a disservice to batterers and victims.125 the duluth model rejects treatment through insight models, family systems theory, and cbt models, instead favoring a sociopolitical model.126 there has 118. what is the duluth model?, domestic abuse intervention programs, https://www. theduluthmodel.org/what-is-the-duluth-model/ [https://perma.cc/9ftn-l37s] (last visited oct. 17, 2021). 119. id. 120. id. 121. it’s time for domestic violence treatment to grow up, ironshrink (nov. 3, 2006), https://ironshrink.com/2006/11/its-time-for-domestic-violence-treatment-to-grow-up/ [https://perma.cc/tw7r-hf4g]. 122. id. 123. greg bohall et al., intimate partner violence and the duluth model: an examination of the model and recommendations for future research and practice, 31 j. fam. violence 1029, 1031 (2016). 124. id. 125. id. 126. information and advice for everyone affected by family separation to help bring better outcomes for children, the ctr. for separated fams., https://www.separatedfamilies. 2023] the splintered mind and path to a healed society 187 been increasing concern about the use of this approach and its effectiveness.127 2. cognitive behavioral therapy cbt is a psychological treatment that is based on research and clinical practice, and cbt has been proven to be effective for many problems, such as mental illnesses, marital problems, alcohol, and substance use, and much more.128 cbt treatments involve working to change thinking and behavioral patterns.129 cbt primarily focuses on how to help the individual understand their current state, and how to effectively cope with life moving forward.130 cbt therapists work to identify the functional use of violence and its costs and benefits, then work to engage with their client in skill-building in the areas of communication, social skills, assertiveness, and anger management techniques (e.g., time-outs, relaxation training).131 cbt helps individuals break down the problem at hand into five fundamental areas: situations, thoughts, emotions, physical feelings, and actions.132 unlike the duluth model, cbt does not focus on social-political issues and men’s power over women. rather, cbt focuses on “cognitive restructuring” and ways to think about and confront events in a more effective, non-violent way.133 according to mark w. lipsey, “all cognitive-behavioral interventions employ a set of structured techniques aimed at building cognitive skills in areas where offenders show deficits and restructuring cognition in areas where offenders’ thinking is biased or distorted.”134 cbt is a broad concept which can be tailored to focus on various aspects of life and address specific problems, such as emotional and social challenges.135 info/home/practitioner-resources/lz-whats-wrong-with-the-duluth-model/ [https://perma.cc/8lywwujw] (last visited feb. 12, 2022). 127. id. 128. what is cognitive behavioral therapy, am. psych. assoc. (july 2017), https://www.apa. org/ptsd-guideline/patients-and-families/cognitive-behavioral [https://perma.cc/72ew-tp2j]. 129. id. 130. id. 131. gleicher & gilbreath, supra note 110. 132. how it works – cognitive behavioral therapy (cbt), nat’l health serv., https://www.nhs.uk/mental-health/talking-therapies-medicine-treatments/talking-therapies-andcounselling/cognitive-behavioural-therapy-cbt/how-it-works/ [https://perma.cc/pqk9-flk4] (last updated july 16, 2022). 133. kathleen j. ferraro et al., current research on batterer intervention programs and implications for policy, battered women just. project (dec. 2017), https://www.bwjp.org/ assets/batterer-intervention-paper-final-2018.pdf [https://perma.cc/n4n5-55uu]. 134. lipsey et al., supra note 112. 135. kathleen davis, how does cognitive behavioral therapy work?, med. news today (sept. 25, 2018), https://www.medicalnewstoday.com/articles/296579 [https://perma.cc/9gnp7g7t]. 188 indiana health law review [vol. 20:173 cbt helps individuals gain an understanding of their current feelings, beliefs, and attitudes towards a specific situation and aims to transform distorted perceptions and interpretations.136 according to daniel bier, cbt has been called the gold standard of psychotherapy, providing a model to treat everything from mental illness to social problems.137 cbt is more effective at treating domestic violence batterers because there are different models that treat a wide range of conditions.138 therefore, treatment can be tailored to fit each batterers’ needs depending on their circumstances. cbt also aims to disrupt the cycle of unwanted behavior by slowing down the automatic emotional reactions and avoiding instinctive responses.139 because cbt does not focus on the specific problem and focuses on the person’s thoughts and behaviors, it equips the individual with skills that can be used in different situations.140 therefore, cbt does not only address the violence committed by the batterer but will also address the root causes of the violence, such as childhood trauma or substance abuse issues.141 e. the impact of covid-19 on domestic violence domestic violence is a global pandemic that many have been victims of long before the covid-19 pandemic.142 as more individuals spent more time at home due to covid-19’s lockdown, there has been an increase in domestic violence incidents.143 the policies of social distancing, self-isolation and lockdown adopted as a result of covid-19 had an impact on the number of domestic violence occurrences primarily because perpetrators have more opportunities to assert power and dominance over the victim.144 due to the policies adopted as a result of covid-19, access to domestic violence services for the victims are limited, putting victims at a higher risk for serious injury or death, and making it difficult for health care professionals to manage domestic violence cases amidst the covid-19 demand.145 136. id. 137. daniel bier, can cognitive behavioral therapy break the cycle of violence?, freethink (april 18, 2019), https://www.freethink.com/social-change/can-cognitive-behavioraltherapy-break-the-cycle-of-violence [https://perma.cc/c5ed-p8bc]. 138. id. 139. id. 140. davis, supra note 135. 141. id. 142. diana nadine moreira & mariana pinto de costa, the impact of the covid-19 pandemic in the precipitation of intimate partner violence, intel. j. law & psychiatry (june 26, 2020), https://pubmed.ncbi.nlm.nih.gov/32768122/ [https://perma.cc/wqu5-zu6h]. 143. patrice m. hicks et al., the possible impact of increased physical intimate partner violence during the covid-19 pandemic on ocular health, sage open med. (jul. 13, 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8326617/ [https://perma.cc/69j8-dfj6]. 144. moreira & costa, supra note 142. 145. id. 2023] the splintered mind and path to a healed society 189 in 2020, domestic violence cases increased by an average of twenty-five to thirty-three percent globally.146 according to clare cannon, research on domestic violence is often considered a homogeneous category, thus implicitly assumes that individuals experiencing domestic violence share the same life experiences.147 however, in reality, various dimensions of social inequality, such as, gender race and ethnicity, migration, class, physical ability, can intersect to create unique challenges for individuals experiencing domestic violence during a pandemic.148 this research suggests that cbt is an effective model because it takes into consideration a batterers’ life experiences when working on a treatment plan with the batterer. the duluth model, however, will not be effective in addressing the everincreasing domestic violence rate. the duluth model is premised on the fact that men are perpetrators who are violent because society condones male’s violence, and that women are victims who only act in self-defense.149 the duluth model shows blatant bias, and the way it operates is not the result of academic study.150 while the duluth model may have been somewhat effective in past decades, it is no longer effective as it does not take into consideration changes from previous decades. the duluth model may have been effective in previous years because, historically, violence against women was a neglected topic.151 the abuse of women was ignored, denied, made light of, and even legitimized and supported by cultural norms.152 however, over the past twenty years, the gender asymmetry assumptions of domestic violence have been increasingly challenged.153 according to jennifer langhinrichsen-rohling, results from several surveys revealed that the rates with which women reported being violent toward their male partners was similar to, if not even in excess of, the rates with which men reported being violent toward their female partners.154 146. 147. clare e. b. cannon et al., covid-19 intimate partner violence, and communication ecologies, am. behav. scientist (feb. 6, 2021), https://journals.sagepub.com/doi/10.1177/ 0002764221992826 [https://perma.cc/7r3k-r6jz]. 148. id. 149. myth: duluth model, equi-law u.k., https://equi-law.uk/duluth-model/ [https://perma. cc/8jsq-2pun] (last visited mar. 21, 2022). 150. id. 151. jennifer langhinrichsen-rohling et al., rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities, 3 partner abuse 2, https://equi-law.uk/wp-content/uploads/2020/08/bi-directionally_violent_couples.pdf [https://perma.cc/u2fl-4rb7] (last visited feb. 15, 2022). 152. id. 153. id. 154. id. 190 indiana health law review [vol. 20:173 iv. analysis: cognitive behavioral therapy is an effective intervention method to reduce domestic violence recidivism rates the result of a three-year natural field experiment analyzing the effectiveness of cbt and duluth treatment programs showed that the domestic violence recidivism rate was eleven percent higher for offenders who were assigned to a duluth treatment program.155 the major goals of the duluth model (respectful and non-abusive relationships) do not differ from those of other theoretical models of intervention for abusive men (such as cognitive behavioral therapy). however, the means to the end differ significantly from psychological and family systems models that have been proven to be more effective than the duluth model.156 the duluth model claims to be cognitive-behavioral therapy, but it contradicts the tenets of cbt in its practice of gender shaming as an intervention technique.157 a. the difference between the duluth model and cognitive behavioral therapy research has shown that individualized cognitive behavioral therapy for domestic violence offenders reduced physical and emotional abuse during and following treatments.158 studies have also shown that programs that use duluth-like models had no effect on recidivism.159 on the other hand, research has shown that programs that used different methods—namely, cbt—reduced domestic violence recidivism by thirty-three percent.160 in a study assessing domestically violent male u.s. navy personnel, there were no significant differences in recidivism rates between those who were in a cbt program and the no-treatment control group. however, “this study lacked randomization and a control group.”161 the duluth model is a program developed to reduce domestic violence against women.162 the duluth model is known for eliminating the psychology of 155. chad cotti et al., duluth versus cognitive behavioral therapy: a natural field experiment on intimate partner violence diversion programs, j. of experimental psych. applied (june 2020), https://pubmed.ncbi.nlm.nih.gov/31599627/ [https://perma.cc/zq7u-k2x3]. 156. donald g. dutton & kenneth corvo, transforming a flawed policy: a call to revive psychology and science in domestic violence research and practice, aggression & violent behav. (sept. 2006), http://www.mediaradar.org/docs/dutton_corvo-transformingflawedpolicy.pdf [https://perma.cc/n5j2-9ymu]. 157. id. 158. bohall et al., supra note 123. 159. miller et al., supra note 17. 160. id. 161. bohall et al., supra note 123. 162. is the duluth model successful?, psichologyanswers, https://psichologyanswers. com/library/lecture/read/362217-is-the-duluth-model-successful [https://perma.cc/h3nh-v8ua] (last visited dec. 15, 2021). 2023] the splintered mind and path to a healed society 191 violence from treatment and replacing it with gender politics.163 the duluth model ignores the reality that women can also be perpetrators in intimate relationships.164 because the duluth model targets only men as the perpetrators in the relationship, and treats men as having control over women, this method cannot be utilized for same-sex couples or in relationships where the female partner is the perpetrator of violence.165 further, a 2011 study found that there is no clear empirical evidence for either the effectiveness or relative superiority of the duluth model as an intervention method over others.166 in a 2004 comparison study between the cbt and duluth models, the pure cbt had better results.167 at least one study concluded that pure cbt programs, those completely devoid of traditional duluth model components, boasted the most successful results for batterer treatment.168 according to mina elmasry, cbt “has been proven to rehabilitate domestic violence offenders with personality disorders.”169 while this may be true, there is no logical reason why cbt cannot be used for all domestic violence offenders. research has shown that those involved in domestic violence have an underlying factor for their violence.170 therefore, using cbt on all offenders is highly likely to reduce recidivism. the correlation between violence and shaming experiences, however, demands caution against conflating shame with accountability.171 while shame can be an effective and critical tool for behavior modification, its effectiveness is heavily dependent upon how it is imposed or experienced by an individual.172 this research is crucial as it proves another reason the duluth model does not work for individuals who already practice self-shame for their violence. according to donald dutton, a psychologist at university of british columbia, “the duluth model views assault as a choice made by men acting in concert with the norms of a sexist society.”173 but he says that perspective ignores 163. bohall et al., supra note 123. 164. id. 165. id. 166. is the duluth model successful?, supra note 162. 167. johnna rizza, beyond duluth: a broad spectrum of treatment for a broad spectrum of domestic violence, 70 mont. l. rev. 125, 127 (2009). 168. id. 169. mina elmasry, eradicating the plague: charging and sentencing domestic violence offenders using science, not tradition, 47 sw. l. rev. 251, 253 (2017). 170. risk factors for intimate partner violence perpetration, ctrs. for disease control & prevention (oct. 9, 2020), https://www.cdc.gov/violenceprevention/intimatepartnerviolence/ riskprotectivefactors.html [https://perma.cc/7shv-9mmp]. 171. a. rachel camp, pursuing accountability for perpetrators of intimate partner violence: the peril (and utility?) of shame, 98 b. u. l. rev. 1677, 1735 (2018). 172. id. 173. bob kelleher, duluth treatment model is 30 years old; its effectiveness hotly debated, mprnews (oct. 22, 2010), https://www.mprnews.org/story/2010/10/21/duluth-treatment-model [https://perma.cc/ez4c-ms4g]. 192 indiana health law review [vol. 20:173 factors such as poverty, stress, chemical dependency, anxiety, or the man's own lifetime experience of being victimized.”174 further, a study was conducted to examine behavior and belief changes in offenders who participated in a duluth model batterer intervention program revealed that “over one third of the participants from this batterer intervention program eventually reoffended.”175 numerous studies revealed that the duluth model has little or no positive effect on violent behavior. duluth model programs often do not consider a person’s mental health or substance abuse issues.176 according to stefan hofmann, modern cbt refers to a family of interventions that combine a variety of cognitive, behavioral, and emotion-focused techniques.177 according to lily gleicher and jacquelyn gilbreath, the duluth model does not integrate american psychological association’s diagnostic and statistical manual diagnoses and is considered to be a tool for consciousness-raising education, rather than a therapeutic intervention.178 historically, domestic violence was seen as a gender-based phenomenon in which men batter women to maintain their authority in our patriarchal society.179 some research has shown that intimate partner violence by women is equal to or higher than intimate partner violence perpetrated by men.180 according to caroline newman, domestic violence incidents are more commonly reported by heterosexual women, but it is likely to be underreported in men, transgender and gender non-conforming people, and same-sex relationships.181 approximately five-percent of males are killed by their intimate partner annually.182 a review of thirty-one studies examining the rates at which females were the perpetrators in relationships estimates that domestic violence perpetrated by women in the last year was up to sixty-eight percent of all domestic violence cases examined in 174. id. 175. katharine herman et al., outcomes from a duluth model batterer intervention program at completion and long term follow-up, 53 j. offender rehab. (jan 21, 2014), https://www. tandfonline.com/doi/abs/10.1080/10509674.2013.861316 [https://perma.cc/6blu-uyuj]. 176. kenneth corvo et al., do duluth model interventions with perpetrators of domestic violence violate mental health professional ethics?, 19 ethics & behav. 323 (july 23, 2009), https://www.tandfonline.com/doi/abs/10.1080/10508420903035323 [https://perma.cc/9ecszsgl]. 177. stefan hofmann et al., the efficacy of cognitive behavioral therapy, 36 u.s. nat’l lib. med. nat’l inst. health 427 (oct. 1, 2012), https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc3584580 [https://perma.cc/mr42-mry9]. 178. lily gleicher & jacquelyn gilbreath, policies and programs to address individuals who perpetrate intimate partner violence, ill. crim. just. info. (may 11, 2021), https://icjia. illinois.gov/researchhub/articles/policies-and-programs-to-address-individuals-who-perpetrateintimate-partner-violence [https://perma.cc/7vjl-juf2]. 179. bohall et al., supra note 123. 180. id. 181. newman, supra note 86. 182. martin r. huecker et al., domestic violence, statperals, https://www.ncbi.nlm.nih.gov/ books/nbk499891/ [https://perma.cc/r47f-shk6] (last updated feb. 10, 2022). 2023] the splintered mind and path to a healed society 193 those studies.183 over three million acts of domestic violence occur annually to men.184 approximately 800,000 male assaults occur annually.185 mutual violence was reported among more than fifty percent of couples who reported physical violence.186gay, lesbian, bisexual, and transgender domestic violence victims are approximately twenty-five percent, a similar rate to heterosexual women victims.187similarly, the duluth model is also based on gender-specific beliefs.188 and cbt focuses on the perpetrator’s cognition and behavior, regardless of gender and sexual orientation; cbt is more likely to be more effective than the duluth model. furthermore, cbt works by acknowledging that any kind of distress, such as anger, violence, anxiety, and depression are a result of a biased way of thinking.189 the functionality of violent behavior is explored along with the pros and cons of using violence to solve problems and alternative solutions for dealing with antecedents of violence are discussed during cbt sessions.190 a therapist’s role when using cbt is to identify the biases that are resulting in distress and help the client create a cognitive shift.191 mental health practitioners advocate for the use of the individualistic model of intimate partner violence.192 they often recommend treatment for men’s mental illnesses and adopt various psychodynamic approaches.193 psychodynamic programs are founded on the perspective that violence is a symptom of an underlying problem within the violent person requiring therapeutic intervention.194 this goal can be easily met by the use of cbt. finally, research has shown that cbt programs are effective at deterring crime, assisting victims, and preventing recidivism.195 183. alexandra l. snead et al., treatments that work for intimate partner violence: beyond the duluth model: the translation of evidence-based practices to correctional settings, new frontiers in offender treatment (jan. 2018), https://www.researchgate.net/publication/329010138_ treatments_that_work_for_intimate_partner_violence_beyond_the_duluth_model_the_ translation_of_evidencebased_practices_to_correctional_settings [https://perma.cc/ 6mfc-slvb]. 184. huecker et al., supra note 182. 185. id. 186. snead, supra note 183. 187. huecker et al., supra note 182. 188. snead, supra note 183. 189. richard amaral, explaining domestic violence using cognitive-behavioural theory, psychology for growth (mar. 28, 2011), https://psychologyforgrowth.com/2011/03/28/ domestic-violence-an-cbt/ [https://perma.cc/tfw3-kprl]. 190. id. 191. id. 192. snead, supra note 183. 193. id. 194. id. 195. thomas feucht & tammy holt, does cognitive behavioral therapy work in criminal justice?, nat’l inst. just. (may 25, 2016), https://nij.ojp.gov/topics/articles/does-cognitive194 indiana health law review [vol. 20:173 v. the future of cognitive behavioral therapy cbt is more likely to show success at reducing domestic violence and recidivism due to its different models that aim to address various problems that each lead to domestic violence. hence, better results can be accomplished through the adoption of a universal model that can be used across indiana. adopting cbt as the main intervention method in indiana will be effective for many reasons. for example, while cbt is one type of intervention method, it incorporates different models and strategies to personalize services to each batterer. some of the strategies used in cbt are similar to the duluth model, but, unlike the duluth model, those strategies are used in concert with other strategies and not on their own. thus, cbt is more likely to be more effective in appealing to batterers with different experiences due to its flexibility in using diverse strategies. further, the use of a universal model will ensure that all batterers receive the appropriate treatment. this is true to the use of cbt not only because of the different approaches used, but also because cbt can only be delivered by trained professionals. on the other hand, the duluth model can be delivered by any individual as the curriculum is available in an easy-to-follow workbook.196 many companies choose the duluth model because it seems convenient and more affordable. however, the duluth model is rendered expensive and inconvenient when our criminal justice system and society as a whole continue to suffer due to batterers’ recidivism, especially when that recidivism arises because batterers did not receive the proper treatment the first time around. also, allowing untrained individuals to attempt to address a deeply complicated matter robs batterers of the opportunity to effectively rehabilitate and the victims of a chance at redemption. a. a statute adopting cognitive behavioral therapy for indiana to adopt a uniform, effective model to end the domestic violence cycle and reduce recidivism, the state legislature would need to effectuate legislation that mandates cbt to batterers’ sentences. a hypothetical statute that would be successful in adopting a uniform model to combat domestic violence would state the following: 1. individuals convicted of a domestic violence offense, or a domestic violence related offense must complete cognitive behavioral therapy. 2. the specific cognitive behavioral therapy model to be used is to be determined by a trained professional following the completion of an assessment to determine the specific needs of the individual and the best approach necessary to address all issues resulting in domestic violence. behaviora lt h e rapy-work-c r im in a l-ju s t ice -n ew -an a lys is -crimesolu tions#note4 [https://perma.cc/9ngq-v9pb]. 196. domestic abuse intervention programs, books & manuals, https://www. theduluthmodel.org/product-category/booksmanuals/ [https://perma.cc/ey59-3jeb] (last visited feb. 17, 2022). 2023] the splintered mind and path to a healed society 195 3. upon completion of all required services, a progress report must be submitted to the court by the professional with recommendations and feedback as to the progress of the individual participating in therapy, what was accomplished during the therapy, and how the individual can maintain positive progress. 4. at the court’s discretion, after considering the professional’s progress report, the court may order additional services along with the primary cognitive behavioral therapy intervention method. 5. the professional must also provide the client with a copy of the report. furnishing a progress report to the court will work to hold batterers and the professionals administering their care accountable and give victims their due diligence and peace of mind in legitimizing the necessity of cbt treatment for batterers. those steps also give batterers the opportunity to work closely with a professional on targeting specific issues that need to be addressed. whether cbt is administered in a group setting or one on one, the sessions are always confidential, which helps build a trusting relationship between the professional and the client. b. advantages and disadvantages of enacting a statute adopting cognitive behavioral therapy some advantages of adopting a cognitive behavioral therapy statute include the uniformity of using an effective intervention method across a state. also, the high quality of services delivered will more likely lead to successful results and lower recidivism of domestic violence. unlike the duluth model that is based on personal beliefs, cbt has been analyzed by multiple studies where the data was “well-controlled” and “analyzed sufficiently,” and the results repeatedly shown that cbt is effective for a wide range of disorders.197 according to dr. robert l. leahy, “if psychiatry or psychotherapy is to be taken seriously, it must rely on empirical research. we cannot simply use anecdotes, testimonials, narratives, or tirades to guide our choice of treatments.”198 further, unlike the duluth model’s premise that a domestic violence batterer’s only reason for violence is to assert power, control, and dominance over their partner, cbt works with batterers with the idea that there are other deeply rooted struggles that cause the batterer to behave violently towards their partner. cbt works with batterers to address those deeply rooted issues, which, in turn, lowers violent incidents. psychologists agree that cbt examines the origins of the problems presented by individuals.199 according to stefan hofmann, cbt 197. robert l. leahy, cognitive-behavioral therapy: proven effectiveness, cbt is the treatment of choice, psychol. today (nov. 23, 2011), https://www.psychologytoday.com/au/ b log/anxiety-files/201111/cognit ive-behaviora lth e rapy-proven -e f fec t iven ess , [https://perma.cc/6fxr-tctc]. 198. id. 199. id. https://www.psychologytoday.com/au/basics/psychiatry https://www.psychologytoday.com/au/basics/therapy 196 indiana health law review [vol. 20:173 protocols have been developed that specifically address various cognitive and behavioral maintenance factors of various disorders.200 dr. leahy explains the work of judith beck, who describes the formation of early schemas (during childhood) that then direct selective attention and maladaptive coping.201 also, a branch of cbt called focused therapy, founded by jeffrey young, places considerable emphasis on early maladaptive schemas.202 finally, dr. leahy states “sophisticated cognitive therapists utilize case conceptualization, developing a model of the origins of early schemas, linking them to underlying core beliefs and maladaptive assumptions and developing strategies to modify the patient's coping and belief system.”203 moreover, because batterers who undergo cbt receive quality treatment to improve their overall behavior and mental health, cbt is a “one and done” type of treatment. cbt reduces recidivism, which decreases overcrowding in prisons, preserves the criminal justice system’s resources, and puts taxpayer dollars to good use. finally, the positive long-term effects of using an effective intervention method will save victims and children from further harm, reduce crimes and substance abuse, and positively impact society. while the main disadvantage of implementing a cbt statute is that it may be difficult to locate and recruit quality trained professionals, this nuance can be resolved by creating incentives, benefits, and job stability to those interested in this profession. while this may take time and effort, the results will prove that this time and effort was well spent. vi. conclusion because cognitive behavior therapy focuses on a person’s cognitive and aims to change behavior through changing thoughts, it is more likely to reduce recidivism and lower domestic violence rates. the duluth model has not shown significant results in reducing domestic violence rates and recidivism despite the model being used by most states for decades. the duluth model is not effective because it is premised on the belief that men are always the perpetrators in the relationship and that intervention occurs through the shame of violent offenders. this however is not a sound method because it fails to address homosexual relationships and relationships in which women are the violent partners. the duluth model is not effective in those offenders who are prone to self-shame because the “placing shame” theory is no longer effective in those situations.204 further, the duluth model does not take into consideration facets of a batterer’s history such as childhood trauma, witnessing domestic violence as a child, growing up in poverty, having a low educational and developmental level, and any substance or alcohol abuse by the batterer or the batterers’ caregivers. as 200. hofmann et al., supra note 177. 201. leahy, supra note 197. 202. id. 203. id. 204. ferraro et al., supra note 133. https://www.psychologytoday.com/au/basics/attention 2023] the splintered mind and path to a healed society 197 a result, the duluth model is unlikely to see long term change and positive results because the treatment is not tailored to the batterer. instead, the batterer is forced to fit the treatment. cbt is more effective because it uses different models under the cbt umbrella to deliver the best treatment tailored to the client’s needs, whereas the duluth model is used in a “one size fits all” method. because batterers come from different walks of life, and have different life experiences, they cannot all be treated in the same way, making the duluth model a treatment that simply does not work. victims, children, and our society deserve better. jonel newman jonel newman, professor of clinical legal education, received her b.a. with honors, summa cum laude from the university of missouri where she was awarded the william e. kemp prize in literature. she received her j.d. from yale law school, where she was a senior editor of the yale law journal. after clerking for judger. lanier anderson of the u.s. court of appeals for the eleventh circuit, she was a partner in the firm of garrison, silbert & arterton in new haven, connecticut where she had a civil rights, plaintitrs employment law and labor practice. professor newman subse­ quently worked at the connecticut civil liberties union foundation and the florida justice institute, acting as lead counsel in numerous first amendment political and civil rights, law reform, immigration and prisoner litigation cases, as well as at florida legal services, where she was respon­ sible for providing litigation support to legal services organizations throughout florida and for the litigation of migrant farmworker justice project cases. in 2001, she received the john minor wisdom public service and professionalism award from the aba section of litigation and the steven m. goldstein award for excellence from the florida bar founda­ tion for her advocacy on behalf of disabled immigrants. professor newman teaches professional responsibility, civil procedure and directs the health and elder law and medical-legal clinics at the univer­ sity of miami. since 2005 the medical-legal partnership at the university of miami has successfully represented of hundreds of indigent clients who receive care in the adult hiv and other um medical clinics. the clinic's response to the haitian earthquake by providing direct and immediate legal services to haitian nationals in south florida seeking tps status was recog­ nized in 2010 by the clinical legal education association as the year's outstanding public interest project, and by alejandro mayorkas, director of u.s. citizenship and immigration services as an ''extraordinary effort." miami's medical-legal p artnersidp: preparing la wyers and physicians for holistic practice jo~el~e~· i. introduction ............................................................................... 4 73 ii. overview of medical-legal p ar1nerships ........................... 475 ill. the university of miami's evolving medical-legal p ar1nership .................................................................................. 4 76 iv. an interdisciplinary clinic ..................................................... 478 a. referral and access to the medical-legal clinic ..................... 478 b. the clinical model ................................................................... 479 v. lessons, potential pitfalls and promises ............................ 480 i. introduction a fifty-one-year-old veteran, mr. h was hit by a speeding car while riding his motorcycle. while lying on the· side of the road, he was forced to have an emergency, above-the-knee leg amputation. two days later, he had to quit his job as a truck driver and apply for social security disability ben­ efits to support himself. the social security administration denied his claim twice. mr. h became seriously depressed and even thought about taking his own life. he had no income, could not pay bills, and could bare­ ly afford to eat. mr. h's doctors at the va hospital in miami could not understand why social security denied his disability claim, and referred him to the on-site medical-legal clinic. the lawyers and law students worked with the va physicians in the medical-legal clinic to put together evidence for his case that convinced a judge to bypass the typical two-year wait for a hearing and approve mr. h's claim immediately.1 mr. h now • professor of clinical education, director, health and elder law clinic, university of mi­ ami school of law. the author wishes to thank and acknowledge the contributions of the other medical and legal clinicians in the interdisciplinary clinic described below, including panagiota caralis, md, jd, who gave the clinic a home and her inspiration and dedication, edwin olsen, md, jd, and the clinic's associate director, melissa swain, jd, who makes everything work. thanks are also due to deans patricia d. white and patrick 0. gudridge of the university of miami school of law, and deans pascal j. goldschmidt and alex j. mechaber of the miller school of medicine for their support of this program. to jennifer bard and the aals section on law, medicine, and health care for the opportunity to dis­ cuss these observations at the 2012 aals annual meeting, to tony alfieri for thoughtful comments and guidance along the way, and to susan stefan and courtney campbell, both of whom provided valuable feedback. 1. the average amount of time it took to process a hearing request during fiscal year 2010 was 426 days. frequently asked questions: how long does the hearing process nor­ mally take?, soc. sec. admin., http://ssa-custhelp.ssa.gov/app/answers/detailla_id/1160 (last visited june 1, 2012). 474 indiana health law review (vol. 9:2 receives monthly social security disability benefits and associated medi­ caid health insurance coverage, which has reimbursed the hospital that first treated mr. h for the catastrophic costs of mr. h's emergency care and treatment resulting from the accident. without the medical-legal clinic's immediate intervention, mr. h would have waited approximately two years, if he survived, for a social security administrative law judge to adjudicate his case. ms. m, a thirty-year-old veteran, suffered traumatic brain injury as a result of a bomb blast to her vehicle in iraq. she came to the medical-legal clinic because her condition resulted in cognitive impairments, and she no longer felt able to manage her financial affairs. she wanted her mother to be able to take care of her finances for her. once the va physicians in the medical-legal clinic confirmed that ms. m. had capacity to make these important decisions, the clinic prepared a financial durable power of attor­ ney for her, authorizing her mother to manage ms. m's accounts, and peti­ tioned the florida circuit court's probate division to designate ms. m's mother as her future guardian in case her condition worsened. the clinic also completed a living will and designated a health care surrogate for her. at each step in the process, ms. m had access to legal and medical clini­ cians who could explain both the legal import of the documents and the medical aspects of the termination of life prolonging treatments and loss of capacity. having these documents in place gave ms. m tremendous peace of mind and allowed her to concentrate on her recovery. these are only two representative examples of the groundbreaking in­ terdisciplinary medical-legal clinic that the university of miami has pio­ neered with the va medical center in miami. the university of miami's law school and miller school of medi­ cine have for much of the last decade explored innovative and collaborative ways to educate future professionals and to deliver quality care to under­ served populations. in 2011 we experimented with a pilot course that brought faculty and students from both disciplines together for a weekly hospital-based clinical practicum supplemented with interdisciplinary di­ dactic sessions. the interdisciplinary clinic was designed to foster collabo­ rative team-based interdisciplinary work to identify, assess, and treat the medical and legal needs of patient-clients. the purpose of the didactic ses­ sions was to provide clinical students from the law school and the medical residents cross-training in each other's disciplines to the extent necessary to engage in the joint clinical practice.2 the interdisciplinary collaboration between the schools has now grown into a joint clinic and clinical rotation offering for medical students.3 2. unn. of miami law sch., miidicaiilegal intbrdiscipunary clinic, law 744 course description (spring 2011) (on file with author). 3. unn. of miami miller sch. of med., mdr 966, clinical rotation description (2011-2012) (on file with author). 2012] preparing lawyers and physicians for holistic practice 475 we also offer a four-year pathway of emphasis, or area of scholarly concen­ tration, for medical students interested in health law.4 this essay will brief­ ly describe our interdisciplinary medical-legal clinic, and discuss some of the lessons we have learned from our collaborations. it will conclude with a discussion of the promise we believe academically-based medical-legal partnerships, .and especially clinics, hold for the education of tomorrow's lawyers and physicians. ii. overview of medical-legal partnerships across the country, medical-legal partnerships ("mlps") are a grow­ ing trend.5 this service delivery model integrates legal assistance as a ''vi­ tal component ofhealthcare."6 as the medical-legal partnership for health act, introduced by senator harkin iii the 112th congress recognizes, "[f]ormally integrating medical and legal professionals in the health setting can more effectively address the health needs of vulnerable populations and ultimately reduce health disparities."7 the national center for medical­ legal partnership reports 87 programs in its network at 225 hospitals and health centers throughout the country. 8 the focus of these partnerships is primarily on addressing the social determinants of health for low income and vulnerable populations. under the mlp model, attorneys work with front-line health center staff to screen for health-related legal problems, such as family matters (divorce, custo­ dy/visitation, domestic violence), housing problems (eviction, habitability, utility advocacy), special edu­ cation advocacy, immigration issues, disability issues, end-of-life care, employment instability, receipt of public benefits (health insurance, disabil­ ity/supplemental security income, social security in­ come), food security concerns, and additional problems and situations that lead to stress and cause or exacerbate health problems. working with social 4. maya bell, new pathway in health law further personalizes medical education, u. miami miller sch. of med. (jan. 5, 2012), htlp://med.miami.edulnews/new-pathway-in­ liealth-law-further-personalizes-medical-education. · 5. erik eckbolm, when doctor v"uits lead to legal help, n.y. times, mar. 23, 2010, at al5, available at http://www.nytimes.com/20 10/03/24/us/24legal.html. 6. ellen lawton et al., medical-legal partnership: a new standard of care for vul­ nerable populations, in pover1y, realm and law 74 (elizabeth tobin tyler et al. eds., 2011). 7. s. 1609, 112th cong. § 2(a)(4) (2011); cong. rec. 85906 (daily ed. sept. 22, 2011). 8. lawton, supra note 6, at 89. 476 indiana health law review workers and case managers, mlp staff help to secure housing assistance, social security income, public in­ surance, early intervention programs for children with special needs, and other public benefits.9 [vol. 9:2 the delivery of legal services in the health care setting may improve patient health outcomes,10 increase revenue for health providers,11 and re­ duce overall health care costs by reducing the number of emergency room visits and hospitalizations.12 ill. the university of miami's evolving medical-legal partnership the health and elder law clinic and its predecessor, the community health rights education clinic, were originally founded by anthony alfie­ ri based on the cross-disciplinary, medical-legal model of community advo­ cacy developed by professors gary bellow and jeanne cham at harvard law school's wilmerhale legal services center in the 1980s.13 the har­ vard project conducted "legal check-ups" at the brigham and women's hospital ambulatory care waiting room.14 lawyers assessed the client's profile for potential eligibility for various public benefits.15 miami law's 9. peter shin et al., medical-legal partnerships: addressing me unmet legal needs of health center patients 5 (2010), available at http://www.gwumc.edu/ sphhs/departmentslhealthpolicy/dhp _publications/pub_ uploads/dhppublication_ 60ceosb 15056-9d20-3dof917148c7e929.pdf. 10. pascoe pleasence et al., the health cost of civil-law problems: further evidence of links between civil-law problems and morbidity, and the consequential use of health services, 5 j. empirical legal sruo. 351, 365-67 (2008}; david i. schulman et al., public health legal services: a new and powerfol vision, 15 geo. j. on poverty l. & pol'y 729, 7~70 (2008); randye retkjn et al., 1he impact of legal interventions on cancer survivors (2007), available at htlp:/lwww.bc.edu/content/dam/files/schoolsllaw_ sitesllibrary/pdf/content/tremblay_schulman/2007-01-00.retkino/o20et%20al.pdf. 11. jimmy boyle & ada chiu, financial impact snidy of legal health services to new york city hospitals (2009), available at http://legalhealth.orgldocs/ cost_ benefit_ final_ report.pdf. 12. justin fitzgerald, the future of health care: medical-legal partnership for health act, bos. health l. rep., winter 2011, at 13 (describing a pilot study in boston that shows a fifty percent decrease in er visits following a medical-legal intervention). 13. anthony alfieri, (un)covering identity in civil rights and poverty law, 121 harv. l. rev. 805, 821 n.50 (2008) (citing gary bellow & jeanne cham. paths not yet taken: some comments on feldmans critique of legal services practice, 83 geo. l.j. 1633, 1649 n.54, 1659-63 (1995} (describing the medical-legal services project)); anthony alfie­ ri, teaching ethics/doing justice, 73 ford. l. rev. 851, 860-61 (2004) (describing the community health rights education clinic). 14. marybeth musumeci, augmenting advocacy: giving voice to the medical-legal partnership mode/in medicaid proceedings and beyond, 44 u. mich. j.l. reform 857, 885 (2011). 15. id; see also jeffrey selbin & mark del monte, a waiting room of their own: the family care network as a model for providing gender-specific legal services to 20 12] preparing la wyers and physicians for holistic practice 477 health and elder law clinic began by providing similar legal check-ups, analyzing and assessing eligibility for various public benefits· and entitle­ ments, and providing other on-site legal services, with particular emphasis on advance directives, to patients and families in the school ofmedicine's family care and prenatal lllv clinics and the pediatric mobile clinic. ·in 2005 these services were expanded to the adult hn clinic at the university of miami medical school and jackson memorial hospital. the health and elder law clinic conducted office hours on-site four days a week for a patient base of several thousand. (miami-dade county has the third-highest serio-prevalence rate in the nation).16 the clinic also began offering services to patients at jefferson reaves sr. health center, which serves a large, multi-cultural, low-income population in miami's historical­ ly black neighborhood of overtown.t' the legal services offered by the law clinic include representation in social security and other public benefits cases, as well as securing medi­ caid and other insurance. the law clinic also provides drafting and docu:. ment services for advance directives such as wills, living wills, health care surrogacy, pre-need guardianships and guardianships. in addition, the law clinic represents clients in landlord-tenant and immigration cases that have · a health-related nexus. since 2005 the 113 miami law students who have rotated through the health and elder law clinic have, under the supervi­ sion of the clinic's legal staff, provided legal services in more than 1000 cases.18 the clinic strives to provide ''holistic" legal services to the client population it serves by addressing all the clients' legal needs.19 this model of service delivery is especially important for a client population that may have no other alternative for legal services.20 the problems faced by im· poverished and health-impaired clients are often interconnected, as "[p]eople's lives are not neatly compartmentalized.'.21 it was with that un-. derstanding that we began to explore a more interdisciplinary clinical mod­ el, one that truly integrated medical and legal services not only at a single point of entry, but as a fully integrated care and treatment model. women with hiv, 5 duke j. gender l. & pol'y 103, 124-27 (1998) (describing the use of this model as an integrated part of women's mv care). 16. jonel newman, re-conceptualizing poverty law clinical curriculum and legal services practice: the need for generalists, 34 fordham urb; lj. 1303, 1319 (2007). 17. community health centers of excellence, united health found., http://www. unitedhealthfoundation.orgigrants/grantshealthcenters.aspx (last visited may 21, 2012). 18. clinic records, 2005-2012, on file with author. 19. newman, supra note 16, at 1312-16. 20. katherine mattes, the tulane criminal law clinic: an evolution into a combined individual client and advocacy clinic, 18 clinical l. rev. 77, 93 (2011 ). 21. marsha m. mansfield & louise g. trubek, new roles to solve old problems: lawyering for ordinary people in today's context, 56 n.y.l. sch. l. rev. 367,372 (2011). 478 indiana health law review [vol. 9:2 n. an interdisciplinary clinic a. referral and access to the ¥edical-legal clinic in the spring of 2011, working with medical faculty with clinical re­ sponsibilities in the miami va healthcare system, we were able not only to offer services to veterans through the traditional mlp model, but to actually operate a joint clinic. every wednesday, medical residents, medical clini­ cians, law students and clinical legal faculty assembled in one of the miami va's outpatient clinics. patients, referred by their social workers, were booked into the clinic and saw a medical and legal clinician at the same ap­ pointment. we bad previously informed the va social workers about the types of matters the medical-legal clinic was best suited to handle, and we provided a referral form for the patient with check boxes listing these mat­ ters.22 we also bad space for social workers to write in other issues, and they frequently did. the referral form, and the referral process in itself, generated a some­ what unexpected opportunity for interdisciplinary dialogue and education. the lawyers in the partnership had to train the social work staff and medical personnel about what types of legal interventions were possible for a pa­ tient, and also about what types were recommended and why. when we started the clinic, we received a high number of referrals requesting that we establish a guardianship over patients, often elderly, who bad lost some mental capacity and needed a family member or other caretaker to manage their financial affairs and make living arrangements for them. in some in­ stances a guardianship was the recommended outcome for the patient be­ cause the individual no longer possessed sufficient mental capacity to make any decisions. but for many others, the legal needs of the patient could be met through a simple durable power of attorney instrument that avoided a lengthy and expensive court process and better preserved the patient's dig­ nity.23 our discussions with referring social workers in the context of indi­ vidual cases resulted in our law students creating an entire training module for the social work staff at the hospital about the various advance directives available to patients and bow social workers could assist patients in making enforceable long-term decisions before an urgent situation arose, and before 22. the matters we identified and encouraged referrals for included the full range of advance directives and permanency planning documents (wills, living wills, durable power of attorney, health care surrogate, funeral directives, designation of pre-need guardianship, etc.), disability benefits cases, other public benefits cases, medicare and medicaid issues and housing. referral form, on file with author. 23. for a discussion of the drawbacks of the guardianship process, see leslie salzman. rethinking guardianship (again): substituted decision making as a violation of the inte­ gration mandate of title 11 of the americans with disabilities act, 81 u. cow. l. rev. 157 (2010). 2012] preparing lawyers and physicians for holistic practice 479 the patient lost the capacity to make important decisions. 24 b. the clinical model in the medical-legal clinic, when patients presented after having been referred by their social workers, and after authorizing the referral and access to their chart, they were booked into the outpatient clinic like any other patient, and taken to a medical examination room. before the patient was seen by the medical and legal clinicians, the medical staff and clinical supervisors reviewed the patient's chart to familiarize themselves with any medical issues that might arise in the encounter. legal clinicians reviewed the referral forms identifying the legal issue and the relevant legal forms and documents. to continue with the example of a referral to prepare vari­ ous advance directives, if a patient was seen because he or she had request­ ed a will, a living will, health care surrogacy and/or a durable power of attomey,25 then the medical clinician's chart review would focus on any questions about mental capacity, undue influence by a family member or other individual, and whether there were any previously-recorded advance directives in the patient's chart.z6 the legal clinicians would prepare and bring with them a questionnaire designed to facilitate discussion about the patient's desires with respect to advance directives, as well as the forms, which provided a starting point to prepare the requested documents.z7 the medical and legal clinicians then conferred with each other, with the legal clinicians explaining to the medical residents what the various forms ac­ complished, and the medical clinicians providing an overview of the pa­ tient's history and any relevant· medical concerns. the medical and legal clinicians then visited with the patient. first, they confirmed that the pa­ tient's legal need was for advance directives.28 then the medical resident or fellow would assess the patient's decision-making capacity while the law 24. ashley dewelde & david berk, powerpoint presentation: planning for the future: helping patients make enforceable long term decisions (2011) (on file with author). 25. these were the most common advance directives requested and prepared. 26. the va healthcare system laudably incorporates its own version of the living will and health care surrogacy documents into a patient's chart. and all healthcare providers in its system are trained to look for and rely on them. see va form 1-0137: va advance di­ rective, dep't of veterans affairs, http://www.va.gov/vaforms/medical/pdf7vha-10-0137fill.pdf(last modified mar. 2011). 27. in florida, where our clinic practices, some advance directive forms are pre­ scribed or recommended by florida statutes or administrative agency, such as the living will, fla. stat. sec. 765.303 (suggested form of a living will), and the do not resuscitate order, dnro form 1896, florida dept. of health (required form). others, such as the will and the durable power of attorney, are fairly routine, and can often be adapted for each indi­ vidual from a formulaic starting place. 28. sometimes, though not often, the patient's needs and expectations did not match the referral form. additional legal needs often surfaced during the course of the patient en­ counter. for the purposes of illustrating the clinical model, i am using a typical case with a straightforward issue in which neither of those things occurred. 480 indiana health law review [vol. 9:2 student clinician, under the direction of supervising legal faculty, assisted the patient in determining what instructions the patient wanted to give healthcare providers, family, and others. the patient/client care was greatly enhanced by the· interdisciplinary nature of the clinic. a typical patient with an end-stage medical condition who wished to create a living will, for .·example, had the advantage of having an explanation of what he could expect to encounter medically given his particular condition, and how the var­ ious choices he might make concerning life-sustaining treatment would affect him individually, while he simultaneously had access to a legal clini­ cian who could explain the various legal requirements and consequences of the documents, and could adjust the language to tailor the documents to meet the patient's specific needs and wishes. following the patient encounter, and while the patient waited in the examination room, the medical resident or fellow and the law student clini­ cian presented the case to the supervising faculty, and the group worked together to devise and begin to execute a ''treatment plan." in an uncompli­ cated advance directive case such as that described above, the case round would involve making a chart note regarding competency and documenting the encounter along with the patient's preferences so that there was a record of the express wishes before the final documents were created, a discussion ·of what documents needed to be created to meet the patient's needs, and a plan for finishing them and getting them executed and filed in the appropri­ ate places. the clinicians would then be dispatched back to the patient's room to discuss the plan and make follow-up arrangements. however, not all cases followed sljch an uncomplicated trajectory, and in some circum­ stances we found that it was the complicated issues that produced the most memorable outcomes and the most educational experiences for the clinical students, residents, and participating faculty. v. lessons, potential pitfalls and promises patient care and outcomes are improved by this holistic service deliv­ ery model. indeed, in some cases a successful outcome could not have oc­ curred without the interdisciplinary clinical model. one such case involved a stroke victim with aphasia, a condition resulting from damage to the part of the brain that controls language. the fifty-four-year old patient was una­ ble to speak, suffering from severe expressive and receptive deficits con­ sistent with global aphasia. she had no advance directives in place, such as a durable power of attorney, that would permit a family member to take care of her urgent legal and financial matters, including a mortgage foreclo­ sure and the need to contract, and pay for, her placement in a skilled nursing facility. in this case, the interdisciplinary treatn1ent team-lawyers, physi­ cians, and a speech pathologist-was able to create an assessment tool and methodology to determine the patient· had capacity to make decisions, to document that fact, and to create a series of images that permitted the pa2012] preparing lawyers and physicians for holistic practice 481 tient to communicate her desires and to appoint a family member to make and execute financial and legal documents on her behalf.29 without the in­ terdisciplinary medical-legal intervention. the patient would likely have been declared incompetent by the state and appointed a guardian to make all her decisions. 30 significant differences-cultural and regulatory-exist between the medical and legal professions, offering potential pitfalls as well as rich edu­ cational promise. continuing to utilize advance directives as an example, we did not immediately agree in several cases about a patient's mental ca­ pacity to make decisions. a predictable pattern emerged in cases in which capacity was a. close question. medical professionals, students and residents were far more likely to question a patient's mental capacity to make deci­ sions. especially, it seemed to the lawyers and law students, when they believed the patient was not making the healthiest choice, or the choice medical professionals deemed to be in the patient's best interests. on the other hand, the lawyers and law students almost invariably argued passion­ ately in favor of a patient's ''right'' to autonomy and self-direction, even when the patient made poor choices, in the close cases. the lawyers sus­ pected the physicians ofpaternalism,31 while the physicians wondered if the lawyers were naive and irresponsible in advocating, for example, for the restoration of financial control to an impaired patient who was likely to purchase pornography and cigarettes when the patient suffered from copd and had been a poor manager of his money.32 the interdisciplinary case round was an excellent vehicle for uncover­ ing, identifying, and confronting these different predilections. once we were able to engage in a productive discussion about these distinct ap­ proaches, the different professional learners at the table gained significant insight into the formation of professional identity in their own profession as well as the other. medical learners were often surprised to learn that rules governing lawyer conduct permit lawyers a great deal of discretion in mak­ ing their own judgments about a client's capacity, and in advocating on be29. llyas sayeg et al., an interdisciplinary approach for assessing capacity and communicating consent in aphasic patient, abstract #1408, int'l conf. on comm~ in healthcare. summer 2011, at 165, available at http://www.aachonline.org/resource/ resmgr/icchlpostersfinal.pdf. 30. bell, supra note 4. 31. see, e.g., ben a. rich, medical paternalism v. respect for patient autonomy: the more things change the more they remain the same, 10 mich. st. u. j. med. & l. 87 (2006). 32. in this case, the law students succeeded in restoring the patient's access to his own funds. the funds had previously been diverted to an appointed professional agent who charged for her services and had restricted the patients access to his funds, creating and de­ positing into a savings account over his objections and repeated requests to be able to spend his own money. after a robust discussion in case rounds, the medical team supported this request, and assisted by providing competency evaluations. case on file with author. 482 indiana health law review [vol. 9:2 half of clients whose mental disabilities might affect their judgment. 33 medical students were not prepared for what they viewed as the lawyers' almost singte.:.minded dedication to an individual client without regard to broader societal concerns.34 the legal learners were equally surprised to learn not only of the physician's duty to report abuse or neglect,35 even when that violated a patient's trust and confidentiality, but of the physi­ cian's understanding ·of his or her professional duties as encompassing questions of broader public health, which might take precedence· over the physician's loyalty to ariy individual patient.36 the interdisciplinary clinic enhanced the law students' and the physi­ cians' skill development in team-delivered care, responsiveness to commu­ nity and public needs, and inter-professional work. these areas have been identified by the recent carnegie· foundation reports· on medical and legal education as areas to be strengthened and improved. 37 interdisciplinary clinical practice, and the seminar. component that accompanies the clinical immersion, is ideally suited to these challenges. when we began the joint seminar classes, the medical students and residents routinely revealed that they w~e mistrustful of the legal profession, sometimes even calling law­ yers ''the enemy." the law students were surprised to be viewed so dimly, and had uninformed assumptions about physicians that were often untrue. when the curtain was pulled back, and each discipline received some cross­ training, in both the didactic sessions and through the case rounds in indi­ vidual patient care, each set of learners gained respect, appreciation, and· a much better understanding of how each profession approaches problems, patients, and clients. medical and legal learners emerged with better33. see, e.g., aba comm'n on law & agjng, assessment of older adults with diminished capacity: a handbook for lawyers (2005); model rules of prof'l conductr. 1.14 (b) andcmts. 1, 6 (2010). 34. see, e.g., wendy e. parmet, populations, public health, anl> the law 2, 30 (2009) (noting that while "public health focuses on the interests of populations, lawyers are expected to represent the interests of individual· clients," and arguing that lawyers should undertake more ''population-based legal analysis"). 35. fla. stat. § 39.201 (2011) (physician mandatory reporting of suspected child abuse and neglect); fla. stat. § 415.1034 (2011) (physician mandatory reporting of sus­ pected elder abuse, neglect and exploitation). 36. see, e.g., american medical ass'n, rpt. of the council on ethical and judicial affairs, '4-1-06, available at: http://www.ama-assn.org/resources/doc/ethics/ceja_ 4i06.pdf (discussing widespread broad interpretation of the tarasoffdoctrine (tarasoffv. regents of university of california, 17 cal. 3d 425 (1976)), to justify the disclosure of confidential information when it can avert barm to a third party); micah berman, a public health per­ spective on health care reform, 21 health matrix 353, 355-56 (2011); alison patrucco barnes, beyond guardianship reform: a reevaluation of autonomy and beneficence for a system of principled decision;,.making in long term care, 41 emory l.j. 633, 669-74 (1992). 37. molly cooke et al., educating physicians: a call for reform of medical school and residency 25, 56-58, 62-64 (2010); william m. sullivan et al., educating lawyers: preparation for the profession qf law 180-82,192 (2007). 2012] preparing lawyers and physicians for holistic practice 483 formed ethical and professional identities of their own.38 the medical-legal clinic offers unique and cutting-edge opportuni­ ties for research and study. in addition to improved patient care and rich educational experiences, an academically-based medical-legal clinic of­ fers a unique laboratory for research and study. to date, there is a "pauci­ ty" of studies that gather and assess available data on the economic and other measurable benefits of an interdisciplinary medical-legal clinic or of medical-legal partnerships generally.39 we are presently working with the department of epidemiology and public health at the university of miami miller school of medicine to investigate and report on how our partnership impacts patient outcomes, public health, health care costs, and educational outcomes for the participating students. we look forward to reporting the results of these studies in the future. 38. for a lengthy discussion of the benefits of this cross training. including reducing "distrust, fear and antagonism," between the two professions, see elizabeth tobin tyler, allies not adversaries: teaching collaboration to the next generation of doctors and law­ yers to address social inequality, 11 j. healm carel. & pol'y 249, 249-50 (2008) (inter­ nal citation omitted). 39. lauren abel & susan vignola, economic and other benefits associated with the provision of civil legal aid, 9 seatiu!j. soc. just. 139,140 (2010). indiana health law review volume xxi 2024 number 1 articles activating law and human rights to end tuberculosis: an empirical assessment of ten countries’ fulfillment of united nations commitments brian citro * abstract the united nations general assembly held the first-ever high-level meeting on tuberculosis in 2018 (the tb unlhm). in the political declaration that followed, heads of state made ambitious pledges to end tb and drugresistant tb by 2030. among these were pioneering legal and human rights commitments on the right to health, non-discrimination, and access to medicines. in 2020 and 2023, the un secretary-general and world health organization released reports examining countries’ progress toward the un pledges. the reports discuss some human rights initiatives and contain data for key targets, such as reductions in tb incidence and deaths, but they do not empirically evaluate progress toward the legal and human rights commitments. this paper fills this gap by reviewing law and policy in ten countries with high burdens of drug-resistant tb. it develops the tb unhlm legal rights index modeled on the human development index, comprising quantitative indicators for the legal and human rights pledges. using this empirical framework, this paper evaluates over 150 legal instruments from the ten countries and finds that each has failed to meet all three commitments. the results nonetheless demonstrate significant variation among the countries and highlight challenges and opportunities as they work to fulfill their pledges in the new political declaration from the second tb unhlm held in september 2023. ————————————————————————————— * independent researcher and lecturer at the university of chicago; jd, university of chicago law school; bm, northern illinois university. thanks to the global drug-resistant tb initiative for supporting this research, especially fuad mirzayev, medea gegia, fraser wares, ignacio monedero, and sarabjit singh chadha, and thanks to kate sagers de la cruz for her research assistance. indiana health law review [vol. 21:1 2 table of contents i. introduction ii. global context a. drug-resistant tuberculosis iii. assessment scope, methodology, and limitations a. scope 1. tb unhlm commitments 2. legal jurisdictions 3. sources of law b. methodology: tb unhlm legal rights index 1. right to health indicator 2. non-discrimination indicator 3. access to medicines indicator c. limitations iv. assessment results: fulfilling tb unhlm legal and human rights commitments a. tb unhlm legal rights index b. right to health c. non-discrimination d. access to medicines v. conclusion appendix i. introduction in september 2018, the united nations (un) general assembly held the first-ever high-level meeting on the fight against tuberculosis (the tb unhlm).1 the theme was: “united to end tuberculosis: an urgent global response to a global epidemic.”2 during the meeting, the heads of un member states acknowledged that tuberculosis (tb) was the top infectious disease killer at the time and a major cause of death related to antimicrobial resistance. they agreed to accelerate efforts to end tb and reach all affected people with prevention, diagnosis, treatment, and care. the tb unhlm produced a political declaration on the fight against tuberculosis in the form of a un general assembly resolution.3 in the declaration, un member states affirmed that: tuberculosis, including its drug-resistant forms, is a critical challenge ————————————————————————————— 1. united nations high-level meeting on the fight to end tuberculosis, gen. assemb. of the united nations, (sept. 26, 2018), https://www.un.org/pga/73/event/fight-to-endtuberculosis [https://perma.cc/x284-jlpe]. 2. id. 3. g.a. res. 73/3 (oct. 18, 2018). 2024] activating law and human rights 3 to end tuberculosis and the leading cause of death from infectious disease, the most common form of antimicrobial resistance globally and the leading cause of death of people living with hiv, and that poverty, gender inequality, vulnerability, discrimination and marginalization exacerbate the risks of contracting tuberculosis and its devastating impacts, including stigma and discrimination at all ages . . .4 member states committed to meeting ambitious targets in the four years from 2019 to 2022, during which the political declaration runs. these targets include reaching forty-million people with tb treatment, including 1.5 million with drug-resistant tb (dr-tb) and thirty million with preventive treatment.5 in addition to public health targets, countries made three pioneering legal and human rights commitments to “protect and promote” the right to health, “promote and support an end to stigma and . . . discrimination” against people affected by tb, and “[promote] access to affordable medicines.”6 member states also requested the un secretary-general to submit a report in 2020 and conduct a “comprehensive review” in 2023 with the world health organization’s (who) support on “the progress and implementation of the [political declaration] towards agreed tuberculosis goals at the national, regional and global levels.”7 in 2020, the un secretary-general and who released reports highlighting global progress toward the tb unhlm targets and documents containing data on tb funding pledges and public health targets, such as reductions in tb incidence and deaths and increases in treatment access.8 however, the 2020 progress reports do not empirically evaluate progress toward fulfilling the three legal and human rights commitments. instead, the secretary-general’s report discusses a few human rights initiatives, noting that legislators in some “highburden countries have been working . . . to promote laws that protect the rights of people with tb.”9 in their recommendations, the reports call on member states to “[r]eview and update laws, policies and programmers to combat inequalities and eliminate stigma and discriminatory practices in the tb response, working together with civil society and affected communities.”10 in 2023, the un secretary-general and who released their final, ————————————————————————————— 4. id. at 1. 5. id. ¶¶ 24-25. 6. id. ¶ ¶ 19, 37. 7. id. ¶ 53. 8. u.n. secretary-general, progress towards the achievement of global tuberculosis targets and implementation of the political declaration of the high-level meeting of the general assembly on the fight against tuberculosis, a/75/236 (sept. 16, 2020); world health org., overview: progress towards achieving global tuberculosis targets and implementation of the un political declaration on tuberculosis (sept. 23, 2020). 9. u.n. secretary-general, id. ¶ 62(b). 10. id. ¶ 103(a); world health org., supra note 8, at 5. indiana health law review [vol. 21:1 4 comprehensive review of global progress towards the tb unhlm targets.11 the 2023 reviews contain detailed analyses of global progress in meeting public health targets, including reductions in tb incidence and mortality and the number of people treated for tb.12 the reviews also contain socio-economic indicators, such as the number of people with tb who experienced financial hardship because of the disease and global funding levels for tb services.13 however, like the 2020 reports, the 2023 reviews do not empirically evaluate progress toward the tb unhlm legal and human rights commitments. the secretary-general’s report includes a section titled “transforming the tuberculosis response with a focus on human rights, equity, multisectoral engagement and accountability,” but it only briefly mentions some human rights-related initiatives and highlights the engagement of civil society and affected communities in the tb response.14 the report also includes a recommendation calling on member states to “enforce laws, policies and programmes that protect human rights, and eliminate inequalities, stigma and discriminatory practices in the tb response.”15 notably, neither the 2020 nor 2023 progress reports discuss intellectual property or patent policy, despite member states’ commitment in the political declaration to use so-called “flexibilities” from the world trade organization’s trips agreement to address intellectual property and patent-related barriers to tb drugs.16 instead, the secretary-general’s 2020 report highlights global mechanisms and claims that “[b]ilateral and multilateral agreements are helping to make new drugs and diagnostics more affordable.”17 the document only refers to intellectual property barriers in relation to research and development, noting that the “complexity and variability of regulatory processes related to sharing scientific data, patent information, the review of new health products and research protocols also constrain the pace of research” for tb.18 the secretary-general’s 2023 report does not mention intellectual property and only refers to patents once in a sentence asserting that “[e]asily accessible databases on research and development investment, patents and the pricing of medicines can help ensure that investments in innovation lead to equitable access.”19 the secretary-general’s 2023 report does not mention intellectual property and only ————————————————————————————— 11. u.n. secretary-general, comprehensive review of progress towards the achievement of global tuberculosis targets and implementation of the political declaration of the united nations high-level meeting of the general assembly on the fight against tuberculosis, a/78/88 (may 18, 2023); world health org. status update: reaching the targets in the political declaration of the united nations general assembly high-level meeting on the fight against tuberculosis (sept. 2023). 12. u.n. secretary-general, id. ¶¶ 8-15, 18-21; world health org., id. at 3. 13. u.n. secretary-general, id. ¶¶ 16-17, 25-30; world health org., id. at 5. 14. u.n. secretary-general, id. ¶¶ 58-68. 15. id. ¶ 106(a). 16. general assembly, supra note 3, ¶ 19. 3 17. u.n. secretary-general, supra note 8, ¶¶ 45-46. 18. id. ¶ 79. 19. u.n. secretary-general, supra note 1, ¶ 80. 2024] activating law and human rights 5 to end tuberculosis refers to patents once in a sentence asserting that “[e]asily accessible databases on research and development investment, patents and the pricing of medicines can help ensure that investments in innovation lead to equitable access.”20 notwithstanding the failure to consider patent-related barriers to tb medicines, both secretary-general reports acknowledge that “achieving equitable access to new tb medicines and technologies remains a major challenge.”21 in september 2023, the un general assembly held the second tb unhlm.22 the meeting’s theme was “advancing science, finance and innovation, and their benefits, to urgently end the global tuberculosis epidemic, in particular, by ensuring equitable access to prevention, testing, treatment and care.”23 member states reviewed the progress they made in meeting the targets set in 2018 political declaration, and they adopted a new declaration, aiming to end the tb epidemic by 2030.24 a thorough analysis of the 2023 political declaration is beyond the scope of this paper. notably, the declaration recommits member states to protecting and promoting the right to health, increasing access to affordable medicines, and eliminating all forms of tbrelated stigma and discrimination.25 this paper empirically evaluates the fulfillment of member states’ legal and human rights commitments in the 2018 tb unhlm political declaration by examining law and policy in ten countries with high dr-tb burdens. the paper develops the tb unhlm legal rights index, a novel assessment framework modeled on the human development index, comprising the tb unhlm legal rights indicator (lri) and quantitative indicators for the three legal and human rights pledges. using this empirical framework, this paper evaluates more than 150 legal instruments from the ten countries and finds that each nation has failed to meet all three commitments. the assessment nonetheless demonstrates significant variation among the countries and highlights challenges and opportunities for member states as they work to fulfill their pledges in the 2023 political declaration. this paper proceeds as follows. section ii sets the global context, focusing on dr-tb. section iii details the assessment’s scope, methodology, and limitations, introducing the tb unhlm legal rights index. section iv presents the assessment results and discussion. finally, section v concludes and shares reflections on fulfilling the tb unhlm legal and human rights commitments. ————————————————————————————— 20. u.n. secretary-general, supra note 11, ¶ 80. 21. id. ¶ 57; u.n. secretary-general, supra note 8, ¶ 82. 22. united nations high-level meeting on the fight to end tuberculosis, gen. assemb. of the united nations, (sept. 22, 2023), https://www.who.int/activities/preparing-for-the-un-highlevel-meeting-on-the-fight-against-tuberculosis--2023 [https://perma.cc/en45-hqna]. 23. id. 24. g.a. res. 78/5 (oct. 16, 2023). 25. id. ¶¶ 39, 70, 77. indiana health law review [vol. 21:1 6 ii. global context tb is preventable and curable, yet it remains one of the leading causes of death worldwide.26 in 2022, 10.6 million people fell ill with tb, and 1.3 million died—more than 3,500 people a day.27 about 3% of the people who got sick with tb—more than three million overall—were “missed” by national tb programs.28 some of the “missing millions” may have obtained testing and treatment in the private sector, but many likely went undiagnosed and untreated, further contributing to the spread of the disease. the covid-19 pandemic had a terrible impact on the tb response. key global indicators moved in the wrong direction in 2020 for the first time in more than a decade and continued doing so in 2021, placing hard-earned gains at stake.29 in its 2021 global tuberculosis report, who reported that while tb incidence remained essentially the same as the year before, the number of people newly diagnosed with tb and registered by their national health systems fell from 7.1 million to 5.8 million.30 who also reported an increase in tb deaths in 2020 and 2021 for the first time in fifteen years, erasing more than a decade of progress.31 in 2023, who reported “a major global recovery in the number of people diagnosed with tb and treated” during 2022 following these two years of disruptions caused by the covid-19 pandemic.32 notwithstanding this notable recovery, who also reports that “covid-related disruptions” are estimated to have caused about half a million more tb deaths from 2020 to 2022 as compared with the number that would have likely occurred if pre-pandemic trends in tb mortality had continued.33 a. drug-resistant tuberculosis drug-resistant tb (dr-tb) is tb that is resistant to at least one of the main drugs used to treat the disease. dr-tb is one of the most common forms of antimicrobial resistance,34 which who has declared to be one of the top “global ————————————————————————————— 26. taghreed adam et al., global tuberculosis report 2023, world health org., at 1 (2023). 27. id. at 2. 28. id. the first figure is calculated by dividing the total number of people reported as newly diagnosed with tb (7.5 million) by the global number of people estimated to have developed tb (10.6 million) in 2022. the second figure is calculated by subtracting the number of newly diagnosed from the number of people who fell ill. 29. tereza kasaeva, global tuberculosis report 2021, world health org., at v (2021). 30. id. at 1, 4. 31. annabel baddeley et al., global tuberculosis report 2022, world health org., at 2 (2022). 32. global tuberculosis report 2023, supra note 25, at 2. 33. id. 34. global burden of bacterial antimicrobial resistance in 2019: a systematic analysis, antimicrobial resistance collaborators 399 lancet 629 (2022). 2024] activating law and human rights 7 to end tuberculosis public health threats facing humanity.”35 there are several types of dr-tb. multidrug-resistant tb (mdr-tb) is resistant to two of the most effective tb drugs—rifampicin and isoniazid.36 rifampicin-resistant tb (rr-tb) is resistant to rifampicin.37 extensively drug-resistant tb (xdr-tb) is resistant to rifampicin (and possibly isoniazid), at least one fluoroquinolone (levofloxacin or moxifloxacin), and bedaquiline, linezolid, or both.38 preextensively drug-resistant tb (pre-xdr-tb) is resistant to rifampicin (and possibly isoniazid) and at least one fluoroquinolone (levofloxacin or moxifloxacin).39 more than 400,000 people fell ill with mdror rr-tb in 2022.40 however, only 175,650 of those were diagnosed and started on treatment, about two in five people and still below the number diagnosed and treated for dr-tb in 2019 before the pandemic (181,533).41 diagnosing dr-tb requires bacteriological confirmation of tb plus testing for drug resistance using advanced diagnostics, such as rapid molecular tests, culture methods, or sequencing technologies.42 in 2022, only 47% of people newly diagnosed with tb were tested with whorecommended advanced diagnostics that detect drug resistance.43 to explain the gaps in dr-tb incidence and the number of people tested and treated for the disease, experts emphasize the “[p]rohibitive pricing and lack of transparency” around the cost of production of a leading rapid, molecular diagnostic for tb— the genexpert mtb/rif assay, a cartridge-based nucleic acid amplification test.44 the company that manufactures the diagnostic received more than usd 250 million in public funding, primarily from the us government, to develop the technology.45 yet, the diagnostic is prohibitively costly, limiting access to the tests in low-and middle-income countries. a 2019 study modeled the necessary investments required for twenty-four high-burden countries to use the genexpert to meet the tb unhlm target of diagnosing and treating forty————————————————————————————— 35. world health org., global antimicrobial resistance and use surveillance system (glass) report 2021, at 2 (2021). 36. world health org., who consolidated guidelines on tuberculosis, module 4: treatment, drug-resistant tuberculosis treatment, 2022 update, at xi (2022). 37. id. at xii. 38. id. at xi. 39. id. at xii. 40. global tuberculosis report 2023, supra note 25, at 2. 41. id. 42. id. at 28. 43. summary of tuberculosis data: tuberculosis in the world, world health org., https://worldhealthorg.shinyapps.io/tbrief/?_inputs_&group_code=%22global%22&entity_typ e=%22group%22&sidebarcollapsed=true&sidebaritemexpanded=null (last visited jan. 12, 2024). 44. david branigan, realizing returns on u.s. government investments in genexpert diagnostic technologies, treatment action group and médecins sans frontières (sept. 2021), https://www.treatmentactiongroup.org/wp-content/uploads/2021/09/realizing_returns_ govt_investments_genexpert.pdf. [https://perma.cc/6n8h-8873] 45. dzintars gotham et al., public investments in the development of genexpert molecular diagnostic technology, 16 plos one (2021). indiana health law review [vol. 21:1 8 million people by 2023. the analysis revealed that it would require an additional usd one billion in investments—five times the amount invested at the time— to meet the unhlm target.46 in september 2023, under global pressure from advocates, genexpert’s manufacturer reduced the cost of a key component of the diagnostic by 20%.47 médecins sans frontières (doctors without borders) called the reduction a “significant step in the right direction” but noted that the test for the most severe form of tb (xdr-tb) remains prohibitively priced.48 the success rate for mdr-tb treatment is only 63% globally, compared with 88% for drug-sensitive tb treatment.49 until recently, the standard dr-tb treatment comprised a regimen of multiple second-line drugs for at least nine and as long as twenty months.50 this regimen has potentially severe side effects, including cardiac toxicity, depression, liver dysfunction, neuropathy, and hearing loss.51 but after more than forty-years during which no new tb drugs were approved, three newer drugs are now available for dr-tb: bedaquiline, delamanid, and pretomanid. the new drugs have led to shorter, more tolerable dr-tb treatments. these include a six-month treatment for mdr/rr-tb and pre-xdr-tb called bpal(m) and a nine-month, all-oral mdr/rr-tb treatment that eliminates the need for painful injections used in older treatments that can lead to hearing loss.52 however, globally, only 30% of people with dr-tb receive these new, shorter treatments.53 who acknowledges there are “major economic and financial barriers to accessing and completing tb treatment.”54 experts point to intellectual property protections and pricing as major barriers to accessing the new dr-tb drugs.55 the primary patent on the basic compound in the drug delamanid expired in october 2023, but the manufacturer, otsuka, still holds ————————————————————————————— 46. amy s. piatek et al., realizing the “40 by 2022” commitment from the united nations high-level meeting on the fight to end tuberculosis: what will it take to meet rapid diagnostic testing needs?, 7 global health: science and practice 551 (2019). 47. médecins sans frontières, technical brief: access to tb testing and treatments: genexpert and delamanid, at 3 (nov. 2023), https://msfaccess.org/sites/default/files/202311/msf-ac_tb_genexpert%2bdlm_final.pdf. 48. id. 49. global tuberculosis report 2023, supra note 25, at 2. 50. global tuberculosis report 2021, supra note 28, at 19. 51. christoph lange et al., management of drug-resistant tuberculosis, 394 the lancet 953 (2019); francesca conradie et al., bedaquiline–pretomanid–linezolid regimens for drugresistant tuberculosis, 387 new eng. j. med. 810 (2022). 52. who consolidated guidelines on tuberculosis, supra note 35, at xvi. 53. summary of tuberculosis data, supra note 42. 54. global tuberculosis report 2023, supra note 25, at 2. 55. see eskild petersen et al., end of the bedaquiline patent – a crucial development for moving forward affordable drugs, diagnostics, and vaccines for infectious diseases in lowand middle-income countries, 131 int’l j. infectious disease 180 (2023); lindsay mckenna, an activist’s guide to shorter treatment for drug-resistant tuberculosis, treatment action group (nov. 2023), https://www.treatmentactiongroup.org/wp-content/uploads/2023/11/ activists_guide_shorter_tx_dr_tb_2023.pdf; médecins sans frontières, dr-tb drugs under the microscope 2022: pricing and patent landscape of medicines for adults and children, 8th ed. (nov. 2022), https://msfaccess.org/dr-tb-drugs-under-microscope-8th-edition. 2024] activating law and human rights 9 to end tuberculosis secondary patents and further patent applications pending.56 in september 2023, otsuka reduced the price of delamanid for countries buying through the stop tb partnership’s bulk purchasing mechanism, the global drug facility.57 but at $1,700 per six-month treatment course, delamanid remains prohibitively expensive for countries that need it.58 in 2017, researchers estimated that manufacturers could produce and sell delamanid for a profit at $30 to $96 per six-month treatment.59 the drug bedaquiline, manufactured by johnson & johnson, was on patent and priced prohibitively high until its primary patent expired in july 2023,60 and the company, under mounting pressure from a decades-long global advocacy campaign, announced its intention in september 2023 not to enforce its remaining patents on the drug.61 in march 2023, the indian controller of patents also rejected johnson & johnson’s application to extend its patent on bedaquiline in the country, opening the door to indian generic manufacturers to produce the drug for domestic use and global export.62 the tb alliance, a non-profit partnership funded entirely by governments and philanthropies, sponsored the development of the drug pretomanid.63 the tb alliance has signed non-exclusive licensing agreements with several generic manufacturers to produce pretomanid.64 however, experts note that the price of the drug is still high, constituting over 50% of the cost of the bpal(m) regimen, though prices may fall as the other producers enter the market and volumes increase.65 ————————————————————————————— 56. medicines patent pool, medspal medicines patents and licenses database: delamanid 50mg, https://www.medspal.org/?product%5b%5d=delamanid+50+mg&page=1. 57. médecins sans frontières, supra note 46. 58. id. at 4. 59. dzintars gotham et al., estimated generic prices for novel treatments for drug-resistant tuberculosis, 72 j. antimicrobial chemotherapy 1243 (2017). 60. medicines patent pool, medspal medicines patents and licenses database: bedaquiline 100mg, https://www.medspal.org/?product%5b%5d=bedaquiline+100+mg&page=1. 61. médecins sans frontières, supra note 47; johnson & johnson, johnson & johnson confirms intent not to enforce patents for sirturo® (bedaquiline) for the treatment of multidrug-resistant tuberculosis in 134 lowand middle-income countries (sept. 29, 2023), https://www.jnj.com/johnson-johnson-confirms-intent-not-to-enforce-patents-for-sirturobedaquiline-for-the-treatment-of-multidrug-resistant-tuberculosis-in-134-low-and-middleincome-countries. 62. in the matter of patent application no. 1220/mumnp/2009 by janssen pharmaceutica and in the matter representation by way of opposition by network of maharashtra people living with hiv, nandita venkatesan, and phumeza tisile (mar. 23, 2023), available at https://www.patentoppositions.org/en/drugs/bedaquiline/patent_office_decisions/641c1136d270 8f00050ab275; see also sankalp yadav, gautam rawal, and madhan jeyaraman, india’s decision to deny an extension of patent for bedaquiline: a public health imperative, 15 cureus e49542. 63. tb alliance, the pathway to potential new tb treatments, https://www.tballiance.org/ pathway-potential-new-tb-treatments (last visited jan. 12, 2023). 64. tb alliance, realizing our “triple-a mandate” (aug. 14, 2023), https://www.tballiance. org/ news/realizing-our-triple-mandate. 65. mckenna, supra note 54, at 13. indiana health law review [vol. 21:1 10 iii. assessment scope, methodology, and limitations this section lays out the scope, methodology, and limitations of this paper’s empirical assessment framework. a. scope the scope of this assessment involves three parameters: (1) tb unhlm commitments, (2) legal jurisdictions (i.e., countries), and (3) sources of law. 1. tb unhlm commitments un member states made three distinct legal and human rights commitments in the 2018 political declaration from the tb unhlm. they are commitments concerning the right to health, non-discrimination, and access to medicines. the right to health pledge comes primarily from paragraph thirty-seven of the political declaration, in which countries: commit to protect and promote the right to the enjoyment of the highest attainable standard of physical and mental health, in order to advance towards universal access to quality, affordable and equitable prevention, diagnosis, treatment, care and education related to tuberculosis and multidrug-resistant tuberculosis . . . .66 the right to health is also mentioned in paragraph thirteen, in which states: note with concern that the protection and promotion of the right to the enjoyment of the highest attainable standard of physical and mental health, . . . remains challenging, especially in developing countries . . . .67 the non-discrimination commitment also comes primarily from paragraph thirty-seven of the political declaration, in which countries: commit to . . . promote and support an end to stigma and all forms of discrimination, including by removing discriminatory laws, policies and programmes against people with tuberculosis . . . .68 the preamble to the political declaration also mentions discrimination. ————————————————————————————— 66. g.a. res. a/res/73/3 (oct. 18, 2018). (the “right to the enjoyment of the highest attainable standard of physical and mental health” is the full term for the “right to health” as enshrined in article 12 of the international covenant on economic, social and cultural rights. g.a. res. 2200a (xxi), ¶ 37 (dec. 16, 1966)). 67. g.a. res. 2200a (xxi), ¶ 13 (dec. 16, 1966). 68. id. ¶ 37. 2024] activating law and human rights 11 to end tuberculosis states affirm that “poverty, gender inequality, vulnerability, discrimination and marginalization exacerbate the risks of contracting tuberculosis and its devastating impacts, including stigma and discrimination . . . .”69 countries raise “serious concerns” about the “enormous costs” people affected by tb incur from stigma and discrimination in paragraph seven.70 and countries make further commitments to reducing discrimination and ensuring the nondiscriminatory “involvement of communities and civil society” in the disease response in paragraphs fourteen and seventeen, respectively.71 the access to medicines pledge comes primarily from paragraph nineteen, in which states: commit to promoting access to affordable medicines, including generics, for scaling up access to affordable tuberculosis treatment, including the treatment of multidrug-resistant and extensively drugresistant tuberculosis, reaffirming the world trade organization agreement on trade-related aspects of intellectual property rights (trips agreement), as amended, and also reaffirming the 2001 world trade organization doha declaration on the trips agreement and public health, which recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of member states to protect public health and, in particular, to promote access to medicines for all, and notes the need for appropriate incentives in the development of new health products.72 countries raise further concerns about the lack of access to affordable tb medicines and diagnostics in paragraphs six and thirteen. they underscore the importance of affordable drugs and diagnostics, including new technologies, to the global disease response in paragraphs nine and forty-five.73 2. legal jurisdictions the ten legal jurisdictions in this assessment are from who’s 2021–2025 list of countries with the highest dr-tb incidence rates, one of three “global lists of [tb] high-burden countries.”74 they are:  china, democratic republic of the congo (drc), india, indonesia, myanmar, nigeria, pakistan, philippines, russian federation, and vietnam. combined, these ten nations also accounted for almost 80% of the global dr————————————————————————————— 69. id. at 1. 70. id. ¶ 7. 71. id. ¶¶ 14, 17. 72. id. ¶¶ 19. 73. id. ¶¶ 6, 9, 13, 45. 74. global tuberculosis report 2022, supra note 30. the full list contains 30 countries: 20 with the highest mdr/rr-tb incidence rates in absolute numbers plus the 10 (not already in the top 20) with the highest number of new cases per 100,000 people worldwide. indiana health law review [vol. 21:1 12 tb treatment gap in 2019, the first year of the tb unhlm political declaration.75 in other words, at that time, approximately 80% of people with dr-tb worldwide who could not access treatment resided in these ten countries. 3. sources of law this assessment examines three sources of law at the national level in each country—constitutions, legislation, and executive branch materials. the review does not consider sources of law from subnational jurisdictions, such as states, provenances, districts, or cities. constitutions comprise each state’s national constitution. legislation encompasses laws and statutes enacted by legislatures, including health, intellectual property, disability, labor, and other laws. the specific subject matter of the legislation examined is described below in the three commitment indicators. executive branch sources comprise directives promulgated by ministries of health and labor, including regulations, policies, strategic plans, and other decrees. this assessment reviews each source of law using the three indicators developed for the tb unhlm legal and human rights pledges, as detailed in the next section. b. methodology: tb unhlm legal rights index this assessment’s methodology is modeled on the un human development index (hdi).76 the hdi measures the “average achievement in key dimensions of human development,” calculated from the geometric mean of normalized indices for three dimensions—health, education, and standard of living.77 similarly, the tb unhlm legal rights index measures un member states’ fulfillment of the three legal and human rights commitments in the tb unhlm political declaration. the tb unhlm legal rights indicator (lri) is a country’s overall score between zero and one calculated from the arithmetic mean of its three unhlm commitment indicator scores (right to health (rth), non-discrimination (nd), and access to medicines (a2m)): lri = (irth + ind + ia2m) / 3 a country’s lri represents its progress in fulfilling the three tb unhlm legal and human rights pledges. the tb unhlm legal rights index lists the ten assessment countries ranked by their lri scores. this assessment also produces indices for the three commitment indicators—the right to health index, non————————————————————————————— 75.annabel baddeley et al., global tuberculosis report 2020, world health org., at xvii (2020). 76. human development index (hdi), united nations development program, [https://perma.cc/h52x-can7] (last visited january 31, 2023). 77. id. 2024] activating law and human rights 13 to end tuberculosis discrimination index, and access to medicines index. like the tb unhlm legal rights index, they comprise lists of the assessment countries ranked by their indicator scores. this assessment uses the arithmetic mean to calculate the lri rather than the geometric mean, as in the hdi, for three reasons. first, the tb unhlm index inputs—the three commitment indices—comprise scaled data sets with scores between zero and one. second, the commitment indices zero to one scale means no large, outlier numbers skew the arithmetic mean. third, the commitment indices’ data sets contain zeros. using the geometric mean would require an imperfect workaround because geometric means always produce a zero when there is a zero in the data set.78 1. right to health indicator as explained above, the right to health commitment indicator stems from paragraph 37 of the tb unhlm political declaration and is formulated as:  explicit recognition and commitment to the right to health. a country’s right to health indicator score is calculated as follows: ————————————————————————————— 78. see roberto de la cruz & jan-ulrich kreft, geometric mean extension for data sets with zeros, cornell, https://arxiv.org/pdf/1806.06403.pdf [https://perma.cc/3kyx-mguh] (last visited january 31, 2023). indiana health law review [vol. 21:1 14 figure 2: right to health indicator source of law score constitutional recognition full recognition 1.0 partial recognition judicial 0.75 state commitment 0.50 legislative recognition health or human rights law 0.50 hiv law 0.15 executive branch recognition 0.25 constitutional recognition means the establishment of a right to health in the national constitution. full recognition requires explicit, unambiguous language establishing an individual right to health (1.0). in the absence of an explicit right to health in the text of the constitution, partial recognition includes either judicial recognition of a constitutional right to health in case law (0.75) or a state commitment in the constitution to protect or promote individual or public health that falls short of establishing an individual right (0.50). legislative recognition means the explicit, unambiguous establishment of a right to health in health or human rights legislation (0.50)79 or hiv legislation (0.15).80 executive branch recognition means the explicit recognition of the right to health in an executive branch decree from the ministry of health (0.25). the right to health indicator score has a minimum value of zero and a maximum value of 1.0 and represents a nation’s progress in fulfilling the tb unhlm right to health commitment. the score is partly additive. partial constitutional recognition is added with legislative recognition or executive branch recognition. legislative recognition and executive branch recognition are also added together. the two elements of partial constitutional recognition— judicial recognition and state commitment to protect or promote health—are mutually exclusive; a country may only receive points for one or the other. any sum above 1.0 is reduced to the maximum value of 1.0. 2. non-discrimination indicator as explained above, the non-discrimination commitment indicator stems from paragraph thirty-seven of the tb unhlm political declaration and is formulated as: ————————————————————————————— 79. this assessment only considers human rights legislation that establishes enforceable, statutory human rights. it does not include laws that solely establish national human rights commissions or equivalent bodies. 80. this assessment includes hiv legislation because tb is the leading killer of people living with hiv, closely connecting the diseases, and many people are co-infected with both. 2024] activating law and human rights 15 to end tuberculosis  explicit prohibition of discrimination against people affected by tb.81 a country’s non-discrimination indicator score is calculated as follows: figure 3: non-discrimination indicator source of law score constitutional recognition health status 0.50 other status, catch-all 0.25 legislative recognition health or human rights law tb, infectious disease 1.0 health status 0.50 disability law tb, infectious disease 0.75 labor law tb, infectious disease 0.50 health status 0.25 hiv law hiv status 0.10 executive branch recognition 0.25 constitutional recognition means the explicit prohibition of discrimination or establishment of the right to be free from discrimination in the national constitution on the basis of health status (0.50), or “other” status or another inclusive, catch-all category (0.25). legislative recognition means the explicit prohibition of discrimination or establishment of a statutory right to be free from discrimination in health or human rights legislation82 on the basis of tb or infectious, contagious, or communicable disease (1.0) or health status (0.50); or in disability legislation on the basis of disability wherein “disability” is explicitly defined to include tb or infectious, contagious, or communicable ————————————————————————————— 81. united nations high-level meeting on the fight to end tuberculosis, supra note 1. (countries further commit in paragraph 37 to “removing discriminatory laws, policies and programmes.” however, this assessment only considers whether countries have affirmatively prohibited discrimination against people affected by tb for two main reasons. first, as with other kinds of discrimination, such racial, ethnic, or gender discrimination, ending discrimination against people affected by tb requires targeted legal prohibitions, not only the elimination of discriminatory policies. second, from a methodological perspective, it is prohibitively difficult to identify laws, policies, or programs that have been removed and are no longer in effect.). 82. as noted above for the right to health indicator, this assessment only considers human rights legislation that establish enforceable, statutory human rights. it does not include laws that solely establish national human rights commissions or equivalent bodies. indiana health law review [vol. 21:1 16 disease (0.75); or in employment or labor legislation on the basis of tb or infectious, contagious, or communicable disease (0.50) or health status (0.25); or in hiv legislation on the basis of hiv status (0.10).83 executive branch recognition means an explicit prohibition of discrimination, the establishment of the right to be free from discrimination, or a specific commitment to nondiscrimination on the basis of tb in health care, employment, education, social protection, housing, or other areas in an executive branch decree from the ministries of health or labor (0.25). the non-discrimination indicator score has a minimum value of 0 and a maximum value of 1.0 and represents a nation’s progress in fulfilling the tb unhlm non-discrimination commitment. the score is partly additive. constitutional recognition for health status or “other” status or catch-all category are mutually exclusive—a country may only receive points for health status recognition or “other” status or a catch-all category recognition. constitutional recognition is added with legislative recognition. legislative recognition in health or human rights legislation, disability legislation, labor legislation, or hiv legislation are all added together. constitutional recognition and legislative recognition are both added with executive branch recognition. any sum above 1.0 is reduced to the maximum value of 1.0. 3. access to medicines indicator as explained above, the access to medicines commitment indicator stems from paragraph nineteen of the tb unhlm political declaration and is formulated as:  commitment to promoting access to affordable medicines through intellectual property law and policy in line with the world trade organization’s agreement on trade-related aspects of intellectual property rights (trips agreement) and its doha declaration. a country’s access to medicines indicator score is calculated as follows: ————————————————————————————— 83. as noted above for the right to health indicator, this assessment includes hiv legislation because tb is a leading killer of people living with hiv, so the diseases are closely connected, and many people are co-infected with both. however, legislative recognition of the nondiscrimination commitment in hiv legislation (0.10) receives less points than legislative recognition of the right to health in hiv legislation (0.15) because discrimination prohibitions protecting people living with hiv are unlikely to apply to all people affected by tb. by contrast, recognition of the right to health in any kind of health-related legislation may have a broader impact across diseases. 2024] activating law and human rights 17 to end tuberculosis figure 4: access to medicines indicator source of law score constitutional recognition access to medicines or health goods, products, or technologies 0.25 legislative or executive branch recognition ip/patent law or regulation 6 trips flexibilities 1.0 5 trips flexibilities 0.75 3-4 trips flexibilities 0.50 1-2 trips flexibility 0.25 textual commitment 0.10 health law or regulation institutional commitment 0.20 textual commitment 0.10 constitutional recognition means an explicit state commitment to promoting access to medicines or health goods, products, or technologies in the national constitution (0.25). legislative or executive branch recognition means recognition of trips flexibilities (6 = 1.0; 5 = 0.75; 3-4 = 0.50; 1-2 = 0.25) or an explicit, textual commitment to promote access to medicines (0.10) in legislation or executive branch decree on intellectual property or patents; or an explicit, textual commitment (0.10) or concrete institutional commitment84— i.e., the establishment of institutional structures, procedures, mandates or authority—(0.20) to promote access to medicines in legislation or executive branch decree on health.85 according to the world trade organization (wto), world intellectual property organization (wipo), and who, trips flexibilities comprise a “wide range of policy options and flexibilities” built into the global intellectual property regime that “can be used to pursue public health objectives.”86 relatedly, in the doha declaration on the trips agreement, wto members ————————————————————————————— 84. for institutional and textual commitments in health legislation or executive branch decree, this assessment considers any kind of explicit commitment to ensuring access to medicines, not only those related to intellectual property or patents. however, it does not include guarantees for access to health care or health services, more broadly. 85. this assessment does not consider tb national strategic plans for executive branch recognition of the access to medicines commitment. tuberculosis national strategic plans do not possess the same level of legal authority as legislation or other executive branch decrees, such as directives, orders, or regulations, that legally mandate certain actions as opposed to setting forth an overarching, often aspirational strategy. 86. world trade org. et al., promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade 21 (2d ed. 2020). indiana health law review [vol. 21:1 18 emphasized the importance of implementing the agreement “in a manner supportive of public health, by promoting both access to existing medicines and research and development into new medicines.”87 this assessment considers six flexibilities:88 1. compulsory licensing or government use—allows governments to grant non-voluntary licenses to third parties to manufacture and sell medicines without the consent of the patent holder or to produce and use the invention themselves for public, non-commercial uses, both subject to payment of adequate remuneration (i.e., a royalty) to the patent holder. 2. parallel importation and the international exhaustion principle—allows drugs legally placed on the market in one country to be imported by another country for sale based on the principle that the patent holder’s exclusive marketing rights were exhausted when it placed the drug on the foreign country’s market. 3. limited exceptions to patent rights for research and experimental use and “early working” or bolar exceptions for regulatory review—allow third parties to use patented medicines for research and experimental purposes and to prepare for regulatory review for generic drugs. 4. heightened patentability criteria—allows governments to set their own legal standards for what constitutes an invention eligible for a patent, including defining “novelty,” “inventive step,” and “industrial application,” and precluding certain things from being patented, such as plants and animals. 5. patent opposition or revocation procedures—allow interested parties other than a patent-holder to challenge drug patents before (opposition) and after (revocation) they are granted. 6. transition period for least developed countries (ldcs)— allows ldcs to refrain from granting or enforcing patent protections for medicines until january 1, 2033, or a later date as agreed upon by wto members.89 the access to medicines indicator score has a minimum value of 0 and a ————————————————————————————— 87. world trade organization, ministerial declaration of 14 november 2001, wto doc. wt/min(01)/dec/1, 17 (2001). 88. for trips flexibilities, report of the united nations secretary-general’s high-level panel on access to medicines: promoting innovation and access to health technologies, (sept. 2016). for patent opposition and revocation procedures, see generally opposition systems, world intell. prop. org., http://www.wipo.int/scp/en/revocation_mechanisms/opposition/ index.html [https://perma.cc/lc58-aarf] (last visited jan. 31, 2023). 89. there are currently forty-six ldcs on the united nations list; thirty-five of them are members of the world trade organization, including the drc. understanding the wto: the organization: least-developed countries, world trade org., http://www.wto.org/english/ thewto_e/whatis_e/tif_e/org7_e.htm [https://perma.cc/4hkd-lrfa] (last visited jan. 31, 2023). 2024] activating law and human rights 19 to end tuberculosis maximum value of 1.0 and represents a nation’s progress in fulfilling the tb unhlm access to medicines commitment. the score is partly additive. constitutional recognition is added with legislative or executive branch recognition. recognition in intellectual property or patent legislation or executive branch decree of 1-6 trips flexibilities are added with textual commitments to promote access to medicines in intellectual property or patent legislation or executive branch decree and textual or institutional commitments in health legislation or executive branch decree. if both textual and institutional commitments occur in the same legislation or executive branch decree, points are only awarded for institutional commitment; if they appear in separate instruments, they are added together. any sum above 1.0 is reduced to the maximum value of 1.0. c. limitations this assessment has two main limitations. first, it does not assess the implementation or enforcement of the sources of law it examines. legal and policy commitments on paper are necessary to fulfill the tb unhlm legal and human rights pledges. but laws and policies must be implemented and enforced to achieve their intended results. notwithstanding this concern, evaluating the implementation and enforcement of more than 150 laws and policies in ten countries would be highly challenging from logistical, financial, and epistemological standpoints. second, due to challenges in identifying, obtaining, and analyzing documents containing the sources of law, the tb unhlm legal rights index may reflect gaps in the underlying research. the challenges included identifying and obtaining documents not available online, searching primarily in english to identify sources of law in other languages, and using unofficial machine translations for documents in non-english languages. to mitigate their impact, the author sent letters to government authorities requesting their assistance in obtaining documents and confirming aspects of the research. the author also engaged lawyers and civil society in the assessment countries to the same ends. the author received further assistance obtaining policy documents from the stop tb partnership country and community support for impact (ccs4i) team that works directly with national tb programs and civil society in the assessment countries. to reduce language barriers in the assessment, the author conducted keyword searches in the original languages for non-english language sources of law. for example, the author searched for the word “discrimination” in bahasa, burmese, chinese, french, russian, and vietnamese while reviewing sources of law for the non-discrimination commitment. indiana health law review [vol. 21:1 20 iv. assessment results: fulfilling tb unhlm legal and human rights commitments this section presents the assessment results of ten high dr-tb-burden countries’ progress in fulfilling their legal and human rights commitments in the tb unhlm political declaration. the subsections contain the four indices, basic quantitative analyses of the results, tabulations of the underlying research and scoring, and brief discussions. a. tb unhlm legal rights index the tb unhlm legal rights index below displays the overall assessment results, with the ten countries ranked in order of their tb unhlm legal rights indicator (lri) scores. table 1: tb unhlm legal rights index tb unhlm commitment indicators right to health nondiscrimination access to medicines lri 1 russia 1.0 1.0 0.90 0.97 2 vietnam 1.0 1.0 0.70 0.90 3 china 1.0 0.75 0.80 0.85 4 indonesia 1.0 0.50 0.90 0.80 5 philippines 1.0 0.35 1.0 0.78 6 drc 1.0 0.25 0.60 0.62 7 india 0.75 0.10 0.95 0.60 8 myanmar 1.0 0.25 0.50 0.58 2024] activating law and human rights 21 to end tuberculosis tb unhlm commitment indicators right to health nondiscrimination access to medicines lri 9 nigeria 0.75 0.35 0.55 0.55 10 pakistan 0 0 0.50 0.17 the tb unhlm legal rights index has a range of 0.80 from 0.17 to 0.97. the mean lri score is 0.682, with a standard deviation of approximately 0.232. the median score is 0.70, and there is no mode. b. right to health the right to health index below displays the ten assessment countries ranked by their right to health indicator scores. table 2: right to health index right to health 1 china 1.0 2 drc 1.0 3 indonesia 1.0 4 myanmar 1.0 5 philippines 1.0 6 russia 1.0 7 vietnam 1.0 8 india 0.75 indiana health law review [vol. 21:1 22 right to health 9 nigeria 0.75 10 pakistan 0 the right to health index has a range of 1.0 from 0 to 1.0. the mean right to health indicator score is 0.85, with a standard deviation of 0.30. the median and mode scores are both 1.0. the research and scoring underlying the right to health index are tabulated here. the table contains the sources of law assessed for each country. as explained above, the assessment evaluated the national constitution of each nation to determine constitutional recognition. countries that received the maximum value (1.0) for full constitutional recognition were not assessed for legislative or executive branch recognition, represented by “n/a” in the table. sources of law for legislative and executive branch recognition listed with specific provisions above an ellipsis contribute to a country’s right to health indicator score. sources of law without specific provisions do not meet the definitions for legislative or executive branch recognition of the right to health commitment. where necessary, scoring designations and information about the author’s ability to obtain sources of law are in brackets and footnotes, respectively. table 3: right to health index scoring and sources of law constitutional recognition legislative recognition executive branch recognition score china 0.50 0.50 0 1.0 arts. 21, 45 [state commitment] law on basic healthcare and health promotion (2020) arts. 4-5 … law on the prevention and treatment of infectious diseases (1989, rev. 2013) implementing measures for the law on the prevention and treatment of infectious diseases (1991) healthy china 2030 blueprint (2016) opinions of the state council on implementing the healthy 2024] activating law and human rights 23 to end tuberculosis constitutional recognition legislative recognition executive branch recognition score china action plan (2019) healthy china action (2019– 2030) (2019) drc 1.0 1.0 art. 47 n/a n/a indonesia 1.0 1.0 art. 28h n/a n/a myanmar 1.0 1.0 art. 367 n/a n/a philippines 1.0 1.0 art. ii, § 15 n/a n/a russia 1.0 1.0 art. 41 n/a n/a vietnam 1.0 1.0 art. 38 n/a n/a india 0.75 0 0 0.75 arts. 21, 39, 47 [judicial recognition] consumer education & research centre v. union of epidemic diseases act (1897) the human immunodeficiency virus and acquired immune deficiency syndrome (prevention and control) act (2017) national health policy 2017 (2017) national strategic plan for tuberculosis: 2017–25, elimination by indiana health law review [vol. 21:1 24 constitutional recognition legislative recognition executive branch recognition score india (1995) 3 scc 42 (india) state of punjab v. mohinder singh chawla (1997) 2 scc 83 (india) epidemic diseases (amendment) act (2020) 2025 (2017) nigeria 0 0.50 0.25 0.75 african charter on human and peoples’ rights (ratification and enforcement) act (1983) art. 16 national health act (2014) § 1(1)(d, e) … hiv and aids (antidiscrimination) act (2014) national health policy 2016 (2016) §§ 3.4.1, 5.3 … national strategic plan for tuberculosis control 2021– 2025 (2021) human rights and gender action plan for tuberculosis care and prevention in nigeria 2021– 2025 (2021)90 pakistan 0 0 0 0 public health (emergency provision) ordinance (1944) west pakistan epidemic diseases act (1958) epidemic diseases (amendment) act (2011) national health vision, 2016– 2025 (2016) national strategic plan for tuberculosis control, 2020– 2023 (2020) ————————————————————————————— 90. surprisingly, the human rights and gender action plan for tuberculosis care and prevention in nigeria 2021–2025 does not recognize the right to health. however, the plan does assert that “the right to health is not guaranteed for most nigerians due to poverty [and] inaccessibility of . . . health care services,” among other things (see page 7). 2024] activating law and human rights 25 to end tuberculosis six of the ten assessment countries score full constitutional recognition (1.0) by enshrining the right to health in their national constitutions. for example, the constitution of the democratic republic of the congo states that the “right to health and to [a] secure food supply is guaranteed.”91 the constitution of indonesia provides that every “person has a right to a life of well-being in body and mind . . . and to receive medical care.”92 by contrast, the constitution of the people’s republic of china contains a state commitment to “protect the people’s health” through the state’s development of health services and promotion of sanitation.93 china nonetheless scores the maximum value 1.0 because its 2019 law of the people’s republic of china on basic healthcare and health promotion establishes that the state shall “respect and protect citizens’ right to health,” including the “right to receive basic medical and healthcare services.”94 the supreme court of india has judicially recognized a constitutional right to health through the right to life and health-related “directive principles of state policy” enshrined in the constitution of india.95 in doing so, the court established a justiciable, individual right to health even though the constitution of india does not explicitly recognize the right. india scores 0.75 as a result, despite not recognizing the right to health through legislation or executive branch decree. similarly, chapter ii of the constitution of the federal republic of nigeria sets forth a series of state objectives for socioeconomic policy. the objectives include pledges to ensure the “health, safety and welfare of all persons in employment” and “adequate medical and health facilities for all persons.”96 however, an earlier provision in the constitution makes these sections nonjusticiable, meaning they are not enforceable in court.97 and unlike india, nigerian courts have not interpreted a justiciable constitutional right to health through the right to life. some courts have nonetheless enforced a statutory right to health in legislation domesticating the regional african charter on human and people’s rights.98 the national health act also commits to “protect, promote and fulfil the rights of the people of nigeria to . . . access . . . health ————————————————————————————— 91. const. (2005), art. 47. (dem. rep. congo). 92. undang-undang dasar negara republik indonesia [constitution] art. 28h(1) (1945) (indon.). 93. xianfa art. 21, § 1 [constitution] (1982) (china). 94. law of the people’s republic of china on basic healthcare and health promotion, arts. 4-5 (2020) (china). 95. india const. art. 21, 39, 47; see also consumer educ. & rsch. ctr. v. union of india, judgment, 1995 3 scc 42 (india) (jan. 27); state of punjab v. mohinder singh chawla, judgment, 1997 2 scc 83 (india) (dec. 17). 96. constitution of nigeria (1999), § 17(3). 97. id. § 6(6)(c). 98. african charter on human and peoples’ rights (ratification and enforcement) act (1983) l.f.n. 1990, cap. 10 (nigeria); odafe. v. attorney general, judgment, 2004 fhc/ph/cs/680/2003 (nigeria) (feb. 23) and georgina ahamefule v. imperial med. ctr., judgment, 2012 id/1627/2000 (nigeria) (sept. 27). indiana health law review [vol. 21:1 26 care.”99 the national health policy further asserts that the right to health is a fundamental right and a “guiding principle” for the policy.100 the policy also calls for a “review of the constitution . . . to make health an enforceable right in nigeria.”101 nigeria thus obtains a score of 0.75 and is the only nation that recognizes the right to health through executive branch decree. the constitution of pakistan does not contain a right to health. but like in india, courts have sometimes given wide meaning to the constitutional right to life. for example, in 1994, the supreme court of pakistan held that environmental hazards threatening human health implicate the constitutional rights to life and dignity.102 more recently, in a 2020 case about the government response to covid-19, the court affirmed the “fundamental right . . . to life, under which [the] government of pakistan is required to provide . . . safe and healthy living conditions.”103 however, in both cases, the court stopped short of declaring a constitutional right to health and has not done so in other rulings. pakistan also does not recognize the right to health through legislation or executive branch decree and therefore scores 0 for the right to health indicator. c. non-discrimination the non-discrimination index below displays the ten assessment countries ranked by their non-discrimination indicator scores. ————————————————————————————— 99. national health act (2014), cap. (a139), §1(1)(e) (nigeria). 100. national health policy (2016), § 3.4.1 (nigeria). 101. id. § 5.3. 102. ms. shehla zia v. wapda, (1994) 1994 pld (sc) 693 (pak.). 103. suo moto action regarding combating the pandemic of corona virus (covid-19), 2020 scmr (sc) 1006 (pak.), https://www.supremecourt.gov.pk/downloads_judgements/ s.m.c._1_2020_19052020.pdf [https:// perma.cc/tmb4-247a]. 2024] activating law and human rights 27 to end tuberculosis table 4: non-discrimination index nondiscrimination 1 russia 1.0 2 vietnam 1.0 3 china 0.75 4 indonesia 0.50 5 nigeria 0.35 6 philippines 0.35 7 drc 0.25 8 myanmar 0.25 9 india 0.10 10 pakistan 0 the non-discrimination index has a range of 1.0 from 0 to 1.0. the mean non-discrimination indicator score is 0.455, with a standard deviation of 0.335. the median score is 0.35, and the modes are 1.0, 0.35, and 0.25. the research and scoring underlying the non-discrimination index are tabulated here. the table contains the sources of law assessed for each kind of recognition for each country. the constitutional recognition column contains the equality and non-discrimination provisions evaluated in each national constitution. sources of law for legislative and executive branch recognition listed with specific provisions above an ellipsis contribute to a country’s nondiscrimination indicator score. sources of law without specific provisions do not meet the definitions for legislative or executive branch recognition of the non-discrimination commitment. information about the author’s assessment or ability to obtain or review sources of law is in footnotes where necessary. indiana health law review [vol. 21:1 28 table 5: non-discrimination index scoring and sources of law constitutional recognition legislative recognition executive branch recognition score russia 0.25 1.0 0 1.0 art. 19(2) law on the basics of health protection of citizens in the russian federation (2011) art. 5(3) … law on social protection of the disabled (1995) law on the sanitary and epidemiologica l welfare of the population (1999) labor code (2001) law on preventing the spread of tuberculosis (2001) law on the circulation of medicines (2010) state strategy for the elimination of tuberculosis in the russian federation until 2025 and beyond (2018) strategy for the development of healthcare in the russian federation for the period until 2025 (2019) vietnam 0.25 1.10 0.25 1.0 art. 16(2) law on prevention and control of infectious disease (2007) art. 8(5) law on vietnam national tuberculosis program draft national strategic plan 2021– 2025 (2020) §§ 3.1.1.4, 3.3.5.4 … 2024] activating law and human rights 29 to end tuberculosis constitutional recognition legislative recognition executive branch recognition score hiv/aids prevention and control (2006, rev. 2020), arts. 3(4), 8, 10(7) … law on persons with disabilities (2010) labor code (2012) plan for people’s health protection, care and promotion 2016–2020 (2016) china 0 0.75 0 0.75 art. 4 law on the prevention and treatment of infectious diseases (1989, rev. 2013) art. 16 employment promotion law (2007, rev. 2015) arts. 25, 26, 30 … law on the protection of persons with disabilities (2008, rev. 2018) law on basic healthcare and health promotion (2020) implementing measures for the law on the prevention and treatment of infectious diseases (1991) administrative measures for the prevention and treatment of tuberculosis (2013) healthy china 2030 blueprint (2016) healthy china action (2019–2030) (2019) opinions of the state council on implementing the healthy china action plan (2019) indonesia 0.25 0 0.25 0.50 indiana health law review [vol. 21:1 30 ————————————————————————————— 104. the preamble of indonesia’s labor law (undang-undang tentang ketenagakerjaan [labor law], no. 13 of 2003) establishes the objective “to secure the implementation of equal opportunity and equal treatment without discrimination on whatever basis.” chapter iii, entitled “equal opportunities,” provides in article 5 that “[e]very person available for a job shall have the same opportunity to get a job without discrimination,” and in article 6 that “[e]very worker/labourer has the right to receive equal treatment without discrimination from their employer.” but the law does not explicitly prohibit discrimination based on tb, infectious disease, or health status. 105. the author was unable to obtain a copy of and thus could not assess the ministry of health circular letter hk.03.03/d1 iii.i/951/2016 on increasing tb case findings. constitutional recognition legislative recognition executive branch recognition score art. 28i health principles law (1960) outbreaks of infectious diseases law (1984) human rights law (1999) labor law (2003)104 medical practice law (2004) heath law (2009) hospital law (2009) law on persons with disabilities (2016) omnibus law on job creation law (2020) presidential regulation 67/2021 on tuberculosis management (2021) arts. 12(8), 24(3), 29(2) national strategy of tuberculosis care and prevention in indonesia 2020–2024 (2020) §§ 4.5.2, 4.5.3, 5.1.5 ministry of health regulation 67/2016 on tuberculosis treatment arts. 7(4), 25(1, 3) … ministry of health decree 1278/menkes/sk/xii/2 009 on guidelines for implementing collaborative tb and hiv control ministry of health circular letter hk.03.03/d1 iii.i/951/2016 on increasing tb case findings105 2024] activating law and human rights 31 to end tuberculosis constitutional recognition legislative recognition executive branch recognition score ministry of health regulation 39/2016 on guidelines for implementing the healthy indonesia program with a family approach ministry of health regulation 43/2016 on minimum health service standards ministry of health strategic plan 2020– 2024 (2020) nigeria 0 0.10 0.25 0.35 art. 15 hiv and aids (antidiscrimination) act (2014) part ii … labour act (1971) african charter on human and peoples’ rights (ratification and enforcement) act (1983) national health act (2014) discrimination against persons with disabilities (prohibition) act (2018) national strategic plan for tuberculosis control, 2021–2025 (2021) §§ 2.2, 2.2.1.2, 4.2.6.2 human rights and gender action plan for tuberculosis care and prevention in nigeria 2021–2025 (2021) §§ 5, 8, 11 … national health policy 2016 (2016) philippines 0 0.10 0.25 0.35 art. iii, § 1 philippine hiv and aids policy act (2018) art. vii guidelines for the implementation of policy and program on tuberculosis (tb) indiana health law review [vol. 21:1 32 constitutional recognition legislative recognition executive branch recognition score labor code of the philippines (1974) magna carta for disabled persons (1992) universally accessible cheaper and quality medicines act of 2008 (2008) comprehensive tuberculosis elimination plan act (2016) universal health care act (2019) prevention and control in the workplace (2005) § 4.1 national tuberculosis control program manual of procedures 6th ed. (2020) ch. 1, 3-4 … the philippine health agenda 2016–2022 (2016) implementing rules and regulations of the comprehensive tuberculosis elimination plan act (2017) strategic framework and implementing guidelines for fourmula one plus for health (f1+) (2018) implementing rules and regulations of universal health care act (2019) national tb control program adaptive plan for the covid19 pandemic (2020) updated philippine strategic tb elimination plan, phase 1: 2020-2023 (2020) drc 0 0 0.25 0.25 2024] activating law and human rights 33 to end tuberculosis ————————————————————————————— 106. article 16 of the drc’s public health law (loi n° 18/035 du 13 décembre 2018 fixant les principes fondamentaux relatifs à l'organisation de la santé publique [public health law], dec. 13, 2018) protects against discrimination in accessing health care, but the law does not prohibit discrimination on grounds of tb, infectious disease, or health status. 107. the author was unable to obtain an english language version of the ပြည်သ ူ့ကျန််းမာရ ်းဥြရေ [public health law], 1972. the burmese language version he obtained was not searchable in burmese and google translate did not produce a coherent english language machine translation of the burmese language document. as a result, the author did not assess this law. constitutional recognition legislative recognition executive branch recognition score art. 13 labor code (2002) law for the protection of the rights of people living with hiv/aids and affected persons (2008) public health law (2018)106 law on the protection and promotion of the rights of persons with disabilities (2022) national strategic plan for the fight against tuberculosis 2021-2022 (2023) (2019) §§ 2.2.7, 6.5.4.7 … national health development plan 2019-2022: towards universal health coverage (2018) myanmar 0 0 0.25 0.25 art. 348 public health law (1972)107 prevention and control of infectious diseases law (1995) amendment of prevention and control of infectious diseases law (2011) employment and skill development national strategic plan 2021-2025: national tb programme (2020) §§ 3.2.3, 3.3 … myanmar national health plan 2017– 2021 (2016) indiana health law review [vol. 21:1 34 ————————————————————————————— 108. ministry of health with fam. welfare, nat’l strategic plan for tuberculosis: 2017–25, elimination by 2025 at 86, 87, and 120 (mar. 2017) mentions discrimination but does not explicitly prohibit discrimination, establish the right to be free from discrimination, or commit to non-discrimination of people affected by tuberculosis. constitutional recognition legislative recognition executive branch recognition score law (2013) the minimum wage law (2013) rights of persons with disabilities law (2015) payment of wages law (2016) shops and workplaces law (2016) myanmar companies law (2017) india 0 0.10 0 0.10 arts. 14, 15, 16 the human immunodeficien cy virus and acquired immune deficiency syndrome (prevention and control) act (2017) § 3 … epidemic diseases act (1897) rights of persons with disabilities act (2016) code on wages (2019) national health policy 2017 (2017) national strategic plan for tuberculosis: 2017–25, elimination by 2025 (2017)108 2024] activating law and human rights 35 to end tuberculosis constitutional recognition legislative recognition executive branch recognition score epidemic diseases (amendment) act (2020) industrial relations code (2020) occupational safety, health and working conditions code (2020) pakistan 0 0 0 0 arts. 25, 26, 27 factories act (1934) public health (emergency provision) ordinance (1944) west pakistan epidemic diseases act (1958) west pakistan industrial and commercial employment (standing orders) ordinance (1968) west pakistan shops and establishments ordinance (1969) disabled persons (employment and rehabilitation) ordinance (1981) national health vision: pakistan 2016–2025 (2016) national strategic plan for tuberculosis control, 2020–2023 (2020) indiana health law review [vol. 21:1 36 russia and vietnam both receive maximum scores of 1.0 by prohibiting discrimination based on disease in legislation. russia “guarantees citizens protection against any form of discrimination due to the presence of any disease.”109 vietnam prohibits “[d]iscriminating against and publishing negative images of and information on persons suffering from an infectious disease.”110 russia and vietnam, along with indonesia, are also the only countries that include inclusive, catch-all categories in their constitutional prohibitions against discrimination. indonesia’s constitution enshrines the right to be free from discrimination “based upon any grounds whatsoever.”111 vietnam’s constitution prohibits discrimination in “political, civic, economic, cultural, and social life,” and russia’s constitution “guarantees the equality of human and civil rights and freedoms regardless” of ten listed categories and any “other circumstances.”112 china’s score of 0.75 results from points awarded for non-discrimination provisions in infectious disease and employment legislation. article 16 of the law on the prevention and treatment of infectious diseases prohibits discrimination against people with infectious diseases.113 article 30 of the employment promotion law prohibits employers from refusing to hire people because they have an infectious disease.114 however, both provisions also bar people affected by tb from jobs prohibited by “laws, administrative regulations, or the health administration department under the state council.”115 the chinese regulations on hygiene management in public places prohibit ————————————————————————————— 109. об основах охраны здоровья граждан в российской федерации [law on the basics of health protection of citizens in the russian federation], 2011, no. 323-fz, art. 5(3), ¶ 2 (russ.). 110. luật phòng, chống bệnh truyền nhiễm [law on prevention and control of infectious disease], no. qh12, art. 8(5). 111. undang-undang dasar negara republik indonesia tahun [uud 1945] [constitution] art. 28i (indon.). 112. hiến pháp nước cộng hòa xã hội chủ nghĩa việt nam [hiến pháp] [constitution] 1992 art. 50 (viet.); konstitutsiia rossiĭskoĭ federatsii [konst. rf] [constitution] art. 19 (russ.). 113. law of the people's republic of china on the prevention and treatment of infectious diseases (promulgated by order no. 17 of the president of the people’s republic of china., aug. 28, 2004), art. 16 (china). 114. employment promotion law of the people's republic of china (promulgated by standing committee of the national people's congress of china., june 29, 2007, effective jan. 1, 2008), art. 30 (china). 115. id.; law of the people's republic of china on the prevention and treatment of infectious diseases, supra note 112. constitutional recognition legislative recognition executive branch recognition score epidemic diseases (amendment) act (2011) 2024] activating law and human rights 37 to end tuberculosis people with pulmonary tb from “direct customer service work until they are cured,” and the general standard for medical examination for civil servants (trial) disqualifies people affected by tb from civil service until one to two years after they are cured.116 people with tb are usually no longer contagious after two weeks of the standard 6-month treatment.117 people who successfully complete tb treatment are considered disease-free and are no longer contagious. therefore, china receives 0.50 rather than 1.0 points for its infectious disease law and 0.25 rather than 0.50 points for its employment law because both laws are subject to overly broad administrative regulations at odds with the non-discrimination commitment in unnecessarily restricting people affected by tb’s employment opportunities. india, nigeria, the philippines, and vietnam prohibit discrimination based on hiv status in hiv legislation, reflecting the proliferation of hiv laws during past decades.118 by contrast, only two countries have enacted tb laws—russia and the philippines—neither of which prohibits discrimination against people affected by tb. the drc has an hiv law, but it does not prohibit discrimination against people living with hiv. in 2006, china’s state council promulgated the “regulations on aids prevention and treatment.”119 the decree prohibits discrimination against people living with hiv. but the state council is an executive branch body, so the regulations do not constitute legislation and do not contribute to china’s non-discrimination indicator score.120 nine countries have strategic plans or implementation guidelines for their national tb programs but only six address discrimination. for example, the drc’s plan includes a section on reducing “stigma and discrimination in tb prevention and care” with ten subsections outlining a detailed approach.121 myanmar’s plan commits to combatting stigma and discrimination through “community engagement” as an “essential intervention” and highlights the need ————————————————————————————— 116. regulations on hygiene management in public places (promulgated by decree of the state council of the people’s republic of china., 1987) no. 24 art. 7 (china) [https://perma.cc/urf5-q74x]; general standards for medical examination for civil servants (trial) (promulgated by circular of the ministry of personnel and the ministry of health., 2005), no. 1, art. 4 (china) [https://perma.cc/w4z2-7lfm]. 117. division of tuberculosis elimination, core curriculum on tuberculosis: what the clinician should know, 139 (centers for disease control and prevention, 7th ed. 2021). 118. see the lancet hiv, time to end discriminatory laws against people with hiv, 8 the lancet hiv e729 (2021); matthew m. kavanagh et al., law, criminalisation and hiv in the world: have countries that criminalise achieved more or less successful pandemic response? 6 bmj global health (aug. 2, 2021). 119. regulations on aids prevention and treatment 2006 (decree no. 457) (promulgated by the state council of the people’s republic of china, jan. 18, 2006) §§ 3, 10 (china). 120. state structure of the people's republic of china: the state council, the nat’l people’s cong. of the people’s republic of china, www.npc.gov.cn/zgrdw/englishnpc/state structure/2007-12/06/content_1382098.htm (last visited jan. 31, 2023) [https://perma.cc/g4djfrs5]. 121. national strategic plan for the fight against tuberculosis 2021-2022 (2023) § 2.2.7 world health org. dem. rep. congo (2019) [https://perma.cc/9mzw-j5fx ]. indiana health law review [vol. 21:1 38 to reduce tb-based discrimination in the workplace.122 by contrast, pakistan’s 100-page plan does not mention discrimination and only refers once to tb stigma in the summary of a sub-national jurisdiction’s plan.123 d. access to medicines the access to medicines index below displays the ten assessment countries ranked by their access to medicines indicator scores. table 6: access to medicines index access to medicines 1 philippines 1.0 2 india 0.95 3 indonesia 0.90 4 russia 0.90 5 china 0.80 6 vietnam 0.70 7 drc 0.60 8 nigeria 0.55 9 myanmar 0.50 10 pakistan 0.50 the access to medicines index has a range of 0.50 from 0.50 to 1.0. the mean access to medicines indicator score is 0.74, with a standard deviation of approximately 0.184. the median score is also 0.74, and the modes are 0.90 and ————————————————————————————— 122. ministry of health and sports, national strategic plan, 2021-2025: national tb programme § 3.2.3, 3.3 world health org. myan. (mar. 2020). 123. ministry of national health services, national strategic plan for tuberculosis control, 2020-2023 § 4 world health org. pak. (2019). 2024] activating law and human rights 39 to end tuberculosis 0.50. the research and scoring underlying the access to medicines index are tabulated here. the table contains the sources of law assessed for each kind of recognition for each country. the constitutional recognition column contains the relevant provisions evaluated in each national constitution when such provisions exist. sources of law for legislative and executive branch recognition listed with specific provisions above an ellipsis contribute points to a country’s access to medicines indicator score. sources of law without specific provisions do not meet the definitions for legislative or executive branch recognition of the access to medicines commitment. information in brackets designates the trips flexibilities and textual and institutional commitments in the sources of law contributing to the indicator scores. table 7: access to medicines index scoring and sources of law constitutional recognition legislative and executive branch recognition score philippines 0.25 1.40 1.0 art. xiii, § 11 intellectual property code (1998, 2015 ed.) § 22.1 [heightened patentability criteria], 72.1 [parallel importation, int’l exhaustion], 72.3 [limited exceptions— research, experimental use], 72.4 [limited exceptions—bolar], 74 [government use], 93 [compulsory licensing] universally accessible cheaper and quality medicines act of 2008 (2008) [institutional, textual commitments] implementing rules and regulations of the comprehensive tuberculosis elimination plan act (2017) § 5.2 [institutional commitment] implementing rules and regulations of universal health care act (2019) § 28 [institutional commitment] universal health care act (2019) § 3(b), 28 [institutional, textual commitments] … indiana health law review [vol. 21:1 40 constitutional recognition legislative and executive branch recognition score comprehensive tuberculosis elimination plan act (2016) india 0 0.95 0.95 the patents (amendment) act (2005) § 3(d) [heightened patentability criteria], 25 [opposition procedures], 64 [revocation procedures], 84, 92, 92a [compulsory licensing, government use], 107a(a) [limited exceptions—bolar], 107a(b) [parallel importation, int’l exhaustion] national health policy 2017 (2017) §§ 3.3.3, 14.4, 14.7, 17 [institutional commitment] … drugs and cosmetics act (1940) indonesia 0 0.90 0.90 law on patents (2016) arts. 19(3) [limited exceptions— research, experimental use], 93, 109, 111 [compulsory licensing, government use], 132 [revocation procedures], 167 [parallel importation, int’l exhaustion] ministry of law and human rights regulation 30/2019 on procedures for granting compulsory patent licenses [compulsory licensing, government use] art. 33(1, 2) [textual commitment] presidential regulation 77/ 2020 on procedures of patent implementation by the government [compulsory licensing, government use] art. 13 [textual commitment] health law (2009) arts. 36-41 [institutional, textual commitments] omnibus law on job creation law (2020) 2024] activating law and human rights 41 to end tuberculosis ————————————————————————————— 124. part 4 of the omnibus law on job creation (2020) amends the compulsory licensing articles of the law on patents (2016) allowing compulsory licenses for patents that have been “exercised by the patent holder . . . [in] a way that detracts from the interests of the community.” indonesia passed a new version of the omnibus job creation law in 2023, repealing the 2020 law. however, this paper’s assessment covers the inclusive four year period 2019-2022 during which the 2018 tb unhlm political declaration was in effect. the new 2023 law is outside this timeframe. constitutional recognition legislative and executive branch recognition score art. 107 [compulsory licensing].124 … presidential regulation 67/2021 on tuberculosis management ministry of health decree 67/2016 on tuberculosis treatment russia 0 0.90 0.90 civil code, part iv, § vii, rights in the results of intellectual activities and means of individualization (2006) arts. 1359(2) [limited exceptions— research, experimental use], 1360, 1362 [compulsory licensing, government use], 1398 [revocation procedures] law on preventing the spread of tuberculosis (2001) art. 14(4) [textual commitment] law on the circulation of medicines (2010) art. 9.3, ch. 12 (arts 60-63) [institutional commitment] law on the basics of health protection of citizens in the russian federation (2011) art. 18(2) [textual commitment] law on amendments to article 60 of the federal law ‘on the circulation of medicines’ and article 38 of the federal law ‘on the basics of protecting the health of citizens in the russian federation’ (2020) [institutional indiana health law review [vol. 21:1 42 ————————————————————————————— 125. the institutional commitment in the law on amendments to article 60 of the federal law ‘on the circulation of medicines’ and article 38 of the federal law ‘on the basics of protecting the health of citizens in the russian federation’ (2020) is not aggregated with the institutional commitment in the law on circulation of medicines (2010) because, as amending legislation, it is technically part of the law on circulation of medicines. 126. the relevant articles in luật của quốc hội: luật sở hữu trí tuệ [law on intellectual property], no. 11/vbhn-vpqh, july 8, 2022 are amended but not meaningfully modified by luật của quốc hội: luật sửa đổi, bổ sung một số điều của luật sở hữu trí tuệ [law amending and supplementing a number of articles of the intellectual property law], no. 07/2022/qh15, june 16, 2022. constitutional recognition legislative and executive branch recognition score commitment].125 china 0 0.80 0.80 patent law (1984, rev. 2020) arts. 54-55 [compulsory licensing], 75(1) [parallel importation, int’l exhaustion], 75(5) [limited exceptions—bolar] implementing rules of the patent law (2010) ch. 5 [compulsory licensing] measures for the compulsory licensing of patent implementation (2012) [compulsory licensing] drug administration law (2019) art. 3 [textual commitment] law on basic healthcare and health promotion (2020) arts. 58-59 [institutional commitment] … implementing measures for the law on the prevention and treatment of infectious diseases (1991) measures for the administration of drug registration (2020) regulations for the implementation of the drug administration law (2020) vietnam 0 0.70 0.70 law on intellectual property (2022)126 arts. 125(2)(a) [limited exceptions—research, bolar], 125(2)(b) [parallel importation, 2024] activating law and human rights 43 to end tuberculosis constitutional recognition legislative and executive branch recognition score int’l exhaustion], 133-133a [government use], § 3 (arts 145-147) [compulsory licensing] plan for people’s health protection, care and promotion 2016–2020 (2016) §§ 2.2 [textual commitment], 4.7 [institutional commitment] … law on prevention and control of infectious disease (2007) guidance the confidential protection of trial data in drug registration (2010) drc 0 0.60 0.60 industrial property law (1982) arts. 49 [limited exceptions—research], 79-82 [compulsory licensing, government use], 149 [revocation procedures] national health development plan 20192022: towards universal health coverage (2018) art. 5.2.5 [textual commitment] nigeria 0 0.55 0.55 patents and designs act (1971) first sch [compulsory licensing, government use] national health act (2014) §§ 2(l) [textual commitment], 11(3)(b) [institutional commitment] national health policy 2016 (2016) § 4.2.5 [textual commitment] myanmar 0 0.50 0.50 patent law (2019) §§ 14(b) [ldcs transition period], 33-35 [opposition procedures], 54(b) [limited exceptions— research, experimental use], 65-73 [compulsory licensing], 77 [revocation procedures] … indiana health law review [vol. 21:1 44 the philippines is the only nation to score the maximum value of 1.0 and obtain points for constitutional, legislative, and executive branch recognition. the philippines has established four trips flexibilities in intellectual property legislation and made both textual and institutional commitments in law and ————————————————————————————— 127. see supra note 113. the author was unable to obtain an english language version of the public health law (1972). the burmese language version he obtained was not searchable in burmese. and google translate did not produce a coherent english language machine translation of the burmese language document. as a result, the author did not assess this law. 128. pak., patents ordinance, ch. 8, § 30(5)(a) (2000), does not mention importation in the statute. additionally, importation is generally prohibited in 30(a, b) for patented products and processes. however, § 30(5)(a) clearly establishes the international principle of exhaustion of patent rights as an exception to the rights of patent holders, establishing that “rights under patent shall not extend” to articles in pakistan that “have been put on the market anywhere in the world.” constitutional recognition legislative and executive branch recognition score public health law (1972)127 prevention and control of infectious diseases law (1995) amendment of prevention and control of infectious diseases law (2011) myanmar national health plan 2017–2021 (2016) pakistan 0 0.50 0.50 patents ordinance (2000) § 23 [opposition procedures], § 30(5)(a) [parallel importation, int’l exhaustion],128 § 30(5)(c, e, f) [limited exceptions—research, bolar], § 46-49 [revocation procedures], § 58 [compulsory licensing, government use] the patent rules (2003) § 18 [opposition procedures], § 26 [revocation procedures], § 44 [compulsory licensing] … public health (emergency provision) ordinance (1944) west pakistan epidemic diseases act (1958) epidemic diseases (amendment) act (2011) national health vision: pakistan 2016– 2025 (2016) 2024] activating law and human rights 45 to end tuberculosis executive branch decrees. the constitution of the philippines commits the country to adopting an “approach to health development which shall endeavor to make essential goods, health and other social services available . . . at affordable cost.”129 the intellectual property law is also remarkable for explicitly addressing access to medicines in the trips flexibilities provisions. for example, section 72.1 establishes limitations on patent rights, including allowing parallel importation of medicines based on the international exhaustion principle. the provision states that “with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has been introduced in the philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention.”130 section 93 sets forth the legal grounds for compulsory licensing, including when “the demand for patented drugs and medicines is not being met to an adequate extent and on reasonable terms.”131 india enacted the patents (amendment) act in 2005 to comply with the trips agreement.132 the law contains five of this assessment’s trips flexibilities, including a provision heightening patentability criteria for medicines. the provision excludes from the statutory definition of “inventions” the “mere discovery of a new form of a known substance which does not result in the enhancement of [its] known efficacy.”133 in 2015, the supreme court of india upheld the provision declaring that it requires new patents for existing chemical substances used in medicine to enhance a drug’s “therapeutic efficacy.”134 the court acknowledged that drug patents might “put[] life-saving medicines beyond the reach” of people who need them.135 and it discussed india’s history of protecting process rather than product patents for medicines that fostered the development of the country’s generic pharmaceutical industry.136 the philippines’ intellectual property code contains an article modeled on the indian provision with the same language requiring the “enhancement of the known efficacy” of new forms of known substances used in medicines.137 india’s patent legislation is also noteworthy because it is the only intellectual property law in this assessment that mentions tb. section 92 sets forth special procedures for granting compulsory licenses during national ————————————————————————————— 129. const. (1987), art. xiii, § 11 (phil.). 130. intell. prop. code, § 72.1, rep. act 8293, as amended (phil.). 131. id. at § 93.6. 132. see shamnad basheer, india’s tryst with trips: the patents (amendment) act, 1 indian j. of l. & tech. 15, 42 (2005). 133. the patents (amendment) act, 2005, § 3(d) (india). 134. novartis ag v. union of india, (2013) 13 s.c.r. 148, 180 (india). 135. id.; see understanding the wto: the organization: least-developed countries supra note 88. 136. id. ¶ 47-59. 137. intell. prop. code, §§ 22.1, 26.2., rep. act 8293, as amended (phil.). indiana health law review [vol. 21:1 46 emergencies or “circumstances of extreme urgency.”138 the procedures supersede the normal statutory requirements and allow the government to expedite the process for granting a compulsory license. the circumstances warranting this expedited process include “public health crises[] relating to . . . tuberculosis.”139 indonesia’s patent legislation and regulations notably include community concerns and drug prices as considerations for challenges and limitations on intellectual property rights. the law on patents empowers individual parties who “represent the national interest” to file suit to revoke a patent “for the benefit of the community.”140 a 2019 regulation on compulsory licensing designates “difficulty . . . accessing drugs in the community” as an “emergency” for which the minister of law and human rights may grant a compulsory license.141 a 2020 presidential regulation on public, non-commercial use authorizes the government to make use of a patent to address “expensive prices” of medicines and other biotechnologies needed to combat a deadly disease.142 russia is the only country that has committed in legislation to providing free medicines to people with tb.143 russia also makes an institutional commitment to access to medicines in its law on the circulation of medicines which authorizes state price controls of drugs on its essential medicines list.144 a 2020 amendment of the law expands the program to allow price controls of drugs not included in the essential medicines list to confront “extraordinary situations” or emerging infectious diseases.145 v. conclusion in 2018, the un general assembly’s high-level meeting on tb prompted countries worldwide to make ambitious commitments to end tb and dr-tb by 2030. these included groundbreaking legal and human rights commitments on ————————————————————————————— 138. the patents (amendment) act, 2005, § 92(1) (india). 139. id. § 92(3). 140. law on patents, no. 13 of 2016, art. 132(4) (indon.); explanation of the law on patents, no. 13 of 2016, § ii (132(4)) (indon.). 141. regulation of the minister of law and human rights, no. 30 of 2019 on procedures for granting a patent's mandatory license, art. 33(2) (indon.). 142. regulation of the president of the republic of indonesia, no. 77 of 2020 on government procedures for implementing patents, art. 13(a) (indon.). 143. федеральный закон "о предупреждении распространения туберкулеза в российской федерации" [federal law on preventing the spread of tuberculosis], no. 77-fz, june 18, 2001, art. 14(4) (russ.). 144. федеральный закон "об обращении лекарственных средств" [federal law on the circulation of medicines], no. 61-fz, apr. 12, 2010, as amended, arts. 9.3, 60-63 (russ.). 145. федеральный закон "о внесении изменений в статью 60 федерального закона "об обращении лекарственных средств" и статью 38 федерального закона "об основах охраны здоровья граждан в российской федерации" [federal law on amendments to article 60 of the federal law “on the circulation of medicines” and article 38 of the federal law “on the basics of protecting the health of citizens in the russian federation”], no. 67-fz, mar. 26, 2020, art. 1 (russ.). 2024] activating law and human rights 47 to end tuberculosis the right to health, non-discrimination, and access to medicines. this paper represents the first effort to empirically measure countries’ progress in fulfilling these pledges. this paper developed and applied a novel empirical framework modeled on the un human development index to assess ten countries with high dr-tb burdens. the results show that none of the countries has fulfilled all three legal and human rights pledges. nonetheless, several nations have fulfilled one commitment, and two have fulfilled two commitments, as illustrated in the tb unhlm legal rights index above. the laws and policies in these countries provide concrete examples of legal instruments that satisfy the legal and human rights pledges as nations work to fulfill their commitments in the new political declaration from the second tb unhlm held in september 2023. however, as noted in the limitations discussed above, this paper’s assessment does not evaluate the implementation or enforcement of these laws and policies. countries must full implement their laws and policies to achieve their intended impact. as a result, even the countries receiving maximum scores (1.0) in this assessment must implement and enforce their laws and policies to fully realize the tb unhlm legal and human rights commitments. to this end, countries whose national constitutions do not fully recognize the right to health should consider amending their constitutions to establish an individual right to health. all nations should consider amending relevant legislation to explicitly prohibit tb-based discrimination. and all countries should consider enshrining the full set of trips flexibilities in intellectual property legislation and regulations while making clear textual and institutional commitments to ensuring access to medicines in patent and health law and policy. indiana health law review [vol. 21:1 48 appendix this appendix contains citations for the legal instruments evaluated in this paper’s assessment listed by country and source of law. china constitutional xianfa [constitution] (1982). legislative zhuānlì fǎ (专利法) [patent law] (promulgated by the standing comm. nat’l people’s cong., mar. 12, 1984, effective apr. 1, 1985). chuánrǎn bìng fángzhì fǎ (传染病防治法) [law on the prevention and treatment of infectious diseases] (promulgated by the standing comm. nat’l people’s cong., feb. 21, 1989, effective sept. 1, 1989). jiùyè cùjìn fǎ (就业促进法) [employment promotion law] (promulgated by the standing comm. nat’l people’s cong., aug. 30, 2007, effective jan. 1, 2008). cánjí rén bǎozhàng fǎ (残疾人保障法) [law on the protection of persons with disabilities] (promulgated by the standing comm. nat’l people’s cong., apr. 24, 2008, effective july 1, 2008). yàopǐn guǎnlǐ fǎ (药品管理法)[drug administration law] (promulgated by the standing comm. nat’l people’s cong., sept. 20, 1984, effective july 1, 1985). jīběn yīliáo hé jiànkāng cùjìn fǎ (基本医疗和健康促进法) [law on basic healthcare and health promotion] (promulgated by the standing comm. nat’l people’s cong., dec. 28, 2019, effective june 1, 2020). executive branch chuánrǎn bìng fángzhì fǎ shíshī bànfǎ (传染病防治法实施办法) [implementing measures for the law on the prevention and treatment of infectious diseases] (implemented by the state council letter [1991] 66 on oct. 4, 1991). 2024] activating law and human rights 49 to end tuberculosis zhuānlì shíshī qiángzhì xǔkě bànfǎ (专利实施强制许可办法) [measures for the compulsory licensing of patent implementation] (promulgated by the state intellectual property office, mar. 15, 2012, effective may 1, 2012). jiéhébìng fángzhì guǎnlǐ bànfǎ (结核病防治管理办法) [administrative measures for the prevention and treatment of tuberculosis] (promulgated by the ministry of health, jan. 9, 2013, effective mar. 24, 2013). zhuānlì fǎ shíshī xìzé (专利法实施细则) [implementing rules of the patent law] (promulgated by the state council of the people's republic of china, june 15, 2001, effective july 1, 2001, rev. jan. 9, 2010). “jiànkāng zhōngguó 2030” guīhuà gāngyào (“健康中国2030”规划纲要) [healthy china 2030 blueprint] (promulgated by the central comm. of the communist party of china and the state council of the people’s republic of china, oct. 25, 2016). jiànkāng zhōngguó xíngdòng (2019—2030 nián) (健康中国行动 (2019—2030 年) [healthy china action (2019–2030)] (promulgated by the healthy china action promotion comm., july 9, 2019). guówùyuàn guānyú shíshī jiànkāng zhōngguó xíngdòng de yìjiàn (国务院关于 实施健康中国行动的意见) [opinions of the state council on implementing the healthy china action plan] (promulgated by the state council of the people’s republic of china, july 15, 2019). yàopǐn zhùcè guǎnlǐ bànfǎ (药品注册管理办法) [measures for the administration of drug registration] (promulgated by the state admin. market regul., jan. 15, 2020, effective july 1, 2020). yàopǐn guǎnlǐ fǎ shíshī tiáolì (药品管理法实施条例) [regulations for the implementation of the drug administration law] (promulgated by the state council of the people's republic of china, aug. 4, 2002, effective sept. 15, 2002). indiana health law review [vol. 21:1 50 democratic republic of the congo constitutional constitution de la république démocratique du congo [constitution] (2005). legislative loi n° 82/001 du 7 janvier 1982 sur la propriété industrielle [industrial property law] (jan. 7, 1982). loi n° 015/2002 du 16 octobre 2002 portant code du travail [labor code] (oct. 16, 2022). loi n° 08/011 du 14 juillet 2008 portant protection des droits des personnes vivant avec le vih/sida et des personnes affectées [law for the protection of the rights of people living with hiv/aids and affected persons] (july 14, 2008). loi n° 18/035 du 13 décembre 2018 fixant les principes fondamentaux relatifs à l'organisation de la santé publique [public health law] (dec. 13, 2018). loi organique n° 22/003 du 3 mai 2022 portant protection et promotion des droits des personnes vivant avec handicap [law on the protection and promotion of the rights of persons with disabilities] (may 3, 2022). executive branch ministry of public health, plan strategique national de lutte contre la tuberculose 2021-2022 (2023) [national strategic plan for the fight against tuberculosis 2021-2022 (2023)] (dec. 2019). ministry of public health, plan national de développement sanitaire recadré pour la période 2019-2022: vers la couverture sanitaire universelle [national health development plan 2019-2022: towards universal health coverage] (sept. 2018). india constitutional const. of india (1950). consumer educ. & rsch. ctr. v. union of india, (1995) 3 scc 42. 2024] activating law and human rights 51 to end tuberculosis state of punjab v. mohinder singh chawla, (1997) 2 scc 83. legislative the epidemic diseases act, 1897. the drugs and cosmetics act, 1940. the patents (amendment) act, 2005. the rights of persons with disabilities act, 2016. the human immunodeficiency virus and acquired immune deficiency syndrome (prevention and control) act, 2017. the code on wages, 2019. the epidemic diseases (amendment) ordinance, 2020. the industrial relations code, 2020. the occupational safety, health and working conditions code, 2020. executive branch ministry of health with family welfare, national health policy 2017 (2017). ministry of health with family welfare, national strategic plan for tuberculosis: 2017–2025 elimination by 2025 (mar. 2017). indonesia constitutional undang-undang dasar negara republik indonesia [constitution] (1945). legislative undang-undang tentang pokok-pokok kesehatan [health principles law], no. 9 of 1960. indiana health law review [vol. 21:1 52 undang-undang tentang wabah penyakit menular [outbreaks of infectious diseases law], no. 4 of 1984. undang-undang tentang hak asasi manusia [human rights law], no. 39 of 1999. undang-undang tentang ketenagakerjaan [labor law], no. 13 of 2003. undang-undang tentang praktik kedokteran [medical practice law], no. 29 of 2004. undang-undang tentang kesehatan [health law], no. 36 of 2009. undang-undang tentang rumah sakit [hospital law], no. 44 of 2009. undang-undang tentang paten [patents law], no. 13 of 2016). undang-undang tentang penyandang disabilitas [law on persons with disabilities], no. 8 of 2016. undang-undang tentang cipta kerja [omnibus law on job creation law], no. 11 of 2020. executive branch keputusan menteri kesehatan tentang pedoman pelaksanaan kolaborasi pengendalian penyakit tb dan hiv [ministry of health decree on guidelines for implementing collaborative tb and hiv control], no. 1278/menkes/sk/xii/2009. surat edaran menteri kesehatan tentang peningkatan penemuan kasus tuberkulosis [ministry of health circular letter on increasing tb case findings], no. hk.03.03/d1 iii.i/951/2016. peraturan menteri kesehatan tentang pedoman penyelenggaraan program indonesia sehat dengan pendekatan keluarga [ministry of health regulation on guidelines for implementing the healthy indonesia program], no. 39 of 2016. peraturan menteri kesehatan tentang standar pelayanan minimal bidang kesehatan [ministry of health regulation on minimum health service standards], no. 43 of 2016. 2024] activating law and human rights 53 to end tuberculosis peraturan menteri kesehatan tentang penanggulangan tuberkulosis [ministry of health regulation on tuberculosis treatment], no. 67 of 2016. peraturan menteri hukum dan hak asasi manusia tentang tata cara pemberian lisensi-wajib paten [ministry of law and human rights regulation on procedures for granting compulsory patent licenses], no. 30 of 2019. rencana strategis kementerian kesehatan tahun 2020-2024 [ministry of health strategic plan 2020–2024] (2020). ministry of health, national strategy of tuberculosis care and prevention in indonesia 2020–2024 (2020). peraturan presiden tentang tata cara pelaksanaan paten oleh pemerintah [presidential regulation on procedures of patent implementation by the government], no. 77 of 2020. peraturan presiden tentang penanggulangan tuberkulosis [presidential regulation on tuberculosis management], no. 67 of 2021. myanmar constitutional ပြည်ရ ာငစ်ုသမမတပမနမ်ာန ငုင်ရံတာ်ဖ ွဲ့စည််းြုံအရပြေြံေဥြရေ [constitution] (2008). legislative ပြည်သ ူ့ကျန််းမာရ ်းဥြရေ [public health law], 1972. က ်းစက်ရ ာဂါမျာ်း ကာက ယ်န မ်နင််းရ ်း ဥြရေ [prevention and control of infectious diseases law], no. 1 of 1995. က ်းစက်ရ ာဂါမျာ်း ကာက ယ် န််းြေျျုြ်ရ ်းဥြရေက ု ပြငဆ်ငသ်ညူ့်ဥြရေ [amendment of prevention and control of communicable diseases law], no. 16 of 2011. အလုြ်အက ငုန် ငူ့ ်ကျွမ််းကျငမ်ှု ဖ ံွဲ့ ဖဖ ျု်းတ ု်းတက်ရ ်းဥြရေ [employment and skill development law], no. 29 of 2013. indiana health law review [vol. 21:1 54 ၂၀၁၃ ြေုန စ်၊ အနည််းဆံ်ုးအြေရ က်းရင ဥြရေ [the minimum wage law], no. 7 of 2013. မသနစ် မ််းသ မျာ်း၏ အြေ ငူ့အ်ရ ်းဥြရေ [rights of persons with disabilities law], no. 30 of 2015. ၂၀၁၆ ြေုန စ်၊အြေရ က်းရင ရြ်းရြေျရ ်းဥြရေ [payment of wages law], no. 17 of 2016. ၂၀၁၆ ြေုန စ်၊ ဆ ငုမ်ျာ်းန ငူ့ ်အလုြ်ဌာနမျာ်းဥြရေ [shops and workplaces law], no. 18 of 2016. ပမနမ်ာန ငုင်ကံမုပဏမီျာ်းဥြရေ [myanmar companies law], no. 29 of 2017. တီ ငမ်ှုမ ြ ုငြ်ေ ငူ့ဥ်ြရေ [patent law], no. 7 of 2019. executive branch ministry of health and sports, myanmar national health plan 2017–2021 (dec. 2016). ministry of health and sports, national strategic plan 2021-2025: national tb programme (mar. 2020). nigeria constitutional const. of nigeria (1999). legislative labour act (1971) l.f.n. 1990, cap. (198). patents and designs act (1971) l.f.n. 1990, cap. (344). african charter on human and peoples’ rights (ratification and enforcement) act (1983) l.f.n. 1990, cap. (10). hiv and aids (anti-discrimination) act (2014) o.g., a123. 2024] activating law and human rights 55 to end tuberculosis national health act (2014) o.g., a139. discrimination against persons with disabilities (prohibition) act (2018) o.g., a97 (2019). executive branch federal ministry of health, national health policy 2016 (sept. 2016). department of public health, human rights and gender action plan for tuberculosis care and prevention in nigeria 2021–2025 (2021). federal ministry of health, national strategic plan for tuberculosis control, 2021–2025 (2021). pakistan constitutional const. of pakistan (1973). legislative factories act, no. xxv of 1934. public health (emergency provision) ordinance, no. xxi of 1944. west pakistan epidemic diseases act, no. xxxvi of 1958. west pakistan industrial and commercial employment (standing orders) ordinance, no. vi of 1968). west pakistan shops and establishments ordinance, no. viii 1969. disabled persons (employment and rehabilitation) ordinance, no. xl of 1981. patents ordinance, no. lxi of 2000, amended by patents (amendment) ordinance, no. xcv of 2002. epidemic diseases (amendment) act, no. xx of 2011. indiana health law review [vol. 21:1 56 executive branch the patent rules, s.r.o.1142 (i)/2003, the gazette of pakistan extraordinary, dec. 31, 2003. ministry of national health services regulations and coordination, national health vision: pakistan 2016–2025 (2016). ministry of national health services, regulations and coordination, national strategic plan for tuberculosis control, 2020–2023 (2020). philippines constitutional const. of the philippines (1987). legislative labor code, pres. dec. no. 442, as amended. magna carta for disabled persons, rep. act no. 7277 (mar. 24, 1992). intellectual property code, rep. act no. 8293, as amended. universally accessible cheaper and quality medicines act of 2008, rep. act no. 9502 (june 6, 2008). comprehensive tuberculosis elimination plan act, rep. act no. 10767 (apr. 26, 2016). philippine hiv and aids policy act, rep. act no. 11166 (dec. 20, 2018). universal health care act, rep. act no. 11223 (feb. 20, 2019). executive branch dept. of labor and employent, guidelines for the implementation of policy and program on tuberculosis (tb) prevention and control in the workplace, dept. ord. no. 73-05 (2005). office of the secretary, the philippine health agenda 2016–2022, admin. ord. no. 2016-0038 (oct. 26, 2016). 2024] activating law and human rights 57 to end tuberculosis office of the secretary of health, implementing rules and regulations of the comprehensive tuberculosis elimination plan act, mem. circ. no. 2017-0014 (may 2, 2017). office of the secretary of health, strategic framework and implementing guidelines for fourmula one plus for health (f1+), admin. ord. no. 20180014 (may 30, 2018). office of the secretary of health, implementing rules and regulations of universal health care act (july 23, 2018). office of the secretary of health, national tb control program adaptive plan for the covid-19 pandemic, admin. ord. no. 2020-0056 (nov. 9, 2020). department of health, national tuberculosis control program manual of procedures 6th edition (2020). department of health, updated philippine strategic tb elimination plan, phase 1: 2020-2023 (2020). russian federation constitutional konstitutsiia rossiĭskoĭ federatsii [constitution] (1993) legislative федеральный закон "о социальной защите инвалидов в российской федерации" [federal law on social protection of disabled people], no. 181fz, nov. 24, 1995, as amended. федеральный закон "о санитарно-эпидемиологическом благополучии населения" [federal law on the sanitary and epidemiological welfare of the population], no. 52-fz, mar. 30, 1999. трудовой кодекс российской федерации [labor code], no. 197-fz, dec. 30, 2001. федеральный закон "о предупреждении распространения туберкулеза в российской федерации" [federal law on preventing the spread of tuberculosis], no. 77-fz, june 18, 2001, as amended. indiana health law review [vol. 21:1 58 гражданский кодекс российской федерации [civil code], part iv, § vii, no. 230-fz, dec. 18, 2006, as amended. федеральный закон "об обращении лекарственных средств" [federal law on the circulation of medicines], no. 61-fz, apr. 12, 2010, as amended. федеральный закон "об основах охраны здоровья граждан в российской федерации" [federal law on the basics of health protection of citizens in the russian federation], no. 323-fz, nov. 21, 2011. федеральный закон "о внесении изменений в статью 60 федерального закона "об обращении лекарственных средств" и статью 38 федерального закона "об основах охраны здоровья граждан в российской федерации" [federal law on amendments to article 60 of the federal law “on the circulation of medicines” and article 38 of the federal law “on the basics of protecting the health of citizens in the russian federation”], no. 67-fz, mar. 26, 2020. executive branch государственная стратегия ликвидации туберкулеза в российской федерации до 2025 года и дальнейшую перспективу [state strategy for the elimination of tuberculosis in the russian federation until 2025 and beyond], 2018. указ президента рф “о стратегии развития здравоохранения в российской федерации на период до 2025 года” [decree of the president of the russian federation “on the strategy for the development of healthcare in the russian federation for the period until 2025”], no. 254, june 6, 2019. vietnam constitutional hiến pháp cộng hòa xã hội chủ nghĩa việt nam [constitution] (1992). legislative luật của quốc hội: luật phòng, chống nhiễm vi rút gây ra hội chứng suy giảm miễn dịch mắc phải ở người (hiv/aids) [law on hiv/aids prevention and control], no. 64/2006/qh11, june 29, 2006, as amended. luật của quốc hội: luật phòng, chống bệnh truyền nhiễm [law on prevention and control of infectious disease], no. 03/2007/qh12, nov. 21, 2007 2024] activating law and human rights 59 to end tuberculosis luật của quốc hội: luật người khuyết tật [law on persons with disabilities], no. 51/2010/qh12, june 17, 2010. luật của quốc hội: bộ luật lao động [labor code], no. 10/2012/qh13, june 18, 2012. luật của quốc hội: luật sở hữu trí tuệ [law on intellectual property], no. 11/vbhn-vpqh, july 8, 2022. executive branch ministry of health, hướng dẫn bảo mật dữ liệu thử nghiệm trong đăng ký thuốc [guidelines for the security of testing data in drug registration], no: 05/2010/tt-byt, mar. 1, 2010. ministry of health, plan for people’s health protection, care and promotion 2016–2020 (mar. 2016). ministry of health, vietnam national tuberculosis program draft national strategic plan 2021–2025 (may 2020). collateral consequences and the right to appeal: reconsidering whether temporary commitment appeals in indiana are moot jonathan b. warner* i. introduction indiana law permits a trial court to order a mentally ill person committed without his or her consent for brief periods of time in certain circumstances.1 if a court orders such a commitment, by the time the committed person is able to obtain appellate review in the indiana court of appeals2 the terms of the commitment will have expired, rendering the appeal moot under existing precedent. this article advocates that, while immediate relief to the committed person may not be available from an appellate court in indiana, nonetheless the potential for harmful collateral consequences from the fact of a temporary commitment prevents these appeals from being deemed moot. this article further contends that, in any event, article 7, section 6 of the indiana constitution prohibits indiana’s appellate courts from categorically declaring these appeals moot. part ii of this article will discuss indiana code chapter 12-26-6, which permits indiana’s trial courts to order temporary commitments not to exceed ninety days, and a typical factual scenario leading to appeal that arises under that chapter.3 part iii will review how indiana’s appellate courts routinely decide such appeals and will include background on the law of mootness in indiana. part iv will present intellectual challenges to the current approach indiana’s appellate courts take to temporary commitment appeals. and part v will suggest the current approach be reconsidered because a temporary commitment carries the potential for harmful collateral consequences and because article 7, section 6 of the indiana constitution prohibits indiana’s appellate courts from categorically declaring temporary commitment appeals moot. ii. temporary commitments indiana code chapter 12-26-6 outlines the procedural requirements through which a party may obtain, and a trial court may order, the temporary commitment * senior deputy judicial law clerk for the honorable edward w. najam, jr. of the indiana court of appeals. lecturer, indiana university–robert h. mckinney school of law. the views expressed in this article are those of the author alone. 1. ind. code §§ 12-26-4-5, -5-1, -6-1 (2016) (providing for twenty-four-hour, seventy-twohour, and ninety-day commitments, respectively). conversely, a regular commitment is a commitment that is expected to require custody, care, or treatment in a facility for more than ninety days. ind. code § 12-26-7-1(2) (2016). 2. appellate jurisdiction in such appeals lies first with the indiana court of appeals and not with the indiana supreme court. see ind. r. app. p. 4-5 (2018). 3. while the focus of this article is on temporary commitments under indiana code chapter 12-26-6, the arguments and reasoning of this article are equally applicable to twenty-four-hour immediate detentions and seventy-two-hour emergency detentions under, respectively, indiana code chapters 12-26-4 and 12-26-5. http://doi.org/10.18060/3911.0050 296 indiana health law review [vol. 15:295 of a mentally ill person without that person’s consent.4 in a typical scenario, a person exhibits erratic behavior in public, which leads to a mental health professional diagnosing that person with a mental illness and requesting the person be committed to a mental health facility for care and treatment. for example, in h.f. v. eskenazi health, h.f. spat in her husband’s face and was admitted to a nearby hospital in a “manic” state.5 a few months later, while at a hotel she “became disruptive and refused security’s request to leave the premises.”6 when police then escorted her off the premises and to a police vehicle, she attempted to open the vehicle’s door by “licking it.”7 later that same night, she visited another hotel and again became disruptive.8 officers then escorted h.f. to eskenazi health midtown community mental health (“eskenazi”), a local mental health clinic.9 there, a psychiatrist diagnosed h.f. as bipolar and attempted to treat her, but she refused to take her prescribed medication and continued her disruptive behavior.10 a few days later, eskenazi petitioned the trial court for h.f.’s involuntary commitment.11 at an ensuing hearing before the court, h.f.’s psychiatrist testified that h.f. had exhibited symptoms of delusions and illogical thoughts; that h.f. did not sleep while in eskenazi’s care; that h.f. attempted to engage her husband in sexual intercourse in front of eskenazi’s staff; and that h.f. had refused to take her prescribed medications.12 h.f.’s psychiatrist further testified that h.f. was gravely disabled and, without treatment, she presented a danger to herself.13 in light of that evidence, the trial court ordered h.f. to be temporarily committed at eskenazi for a period not to exceed ninety days.14 h.f.’s story is, again, a typical fact pattern that results in a person’s temporary involuntary commitment. iii. appellate review of temporary commitments h.f., like many similarly situated persons, sought appellate review of her temporary commitment.15 however, by the time her appeal had been fully briefed for review by the indiana court of appeals, her temporary commitment had 4. ind. code §§ 12-26-6-1 to -11 (2016). 5. h.f. v. eskenazi health, no. 49a02-1602-mh-335, 2016 wl 4585868, at *1 (ind. ct. app. sept. 2, 2016). 6. id. 7. id. 8. id. 9. id. 10. h.f. v. eskenazi health, no. 49a02-1602-mh-335, 2016 wl 4585868, at *1 (ind. ct. app. sept. 2, 2016). 11. id. 12. id. 13. id. 14. id. 15. h.f. v. eskenazi health, no. 49a02-1602-mh-335, 2016 wl 4585868, at *1 (ind. ct. app. sept. 2, 2016). 2018] collateral consequences and the right to appeal 297 expired.16 indeed, in some cases, more than one full year has elapsed between a trial court’s temporary commitment order and the ensuing judgment of the court of appeals.17 indiana case law is clear that “a case is deemed moot when no effective relief can be rendered to the parties before the court.”18 as the indiana supreme court has stated, when an appeal is moot the general rule is that “the case will be dismissed” unless an exception to that general rule applies.19 one such exception allows the court on appeal to reach the merits of an otherwise moot appeal “when the case involves questions of ‘great public interest.’”20 for this exception to apply, the issues on appeal must be “likely to recur.”21 for example, in in re lawrance, the parties before the indiana supreme court asked that court to consider “whether the parents of a patient in a persistent vegetative state may authorize the withdrawal of artificially provided nutrition and hydration from their never-competent daughter.”22 however, during the appeal, the daughter died.23 in light of her death, the court concluded that it could “no longer provide the requested relief to the parties” and, as such, the appeal was moot.24 nonetheless, the court held that it should decide the case on the merits because the issue presented was of great public interest.25 in reaching that conclusion, the court stated: the public interest at stake is demonstrated in part by the great number of high quality amicus briefs submitted to this court. these briefs suggest that, irrespective of the death of the patient in this litigation, 16. id. at *2. 17. e.g., j.m. v. ne. ctr., inc. (in re j.m.), 62 n.e.3d 1208, 1208-10 (ind. ct. app. 2016). indiana appellate rule 14.1, which provides for expedited appeals in limited circumstances, does not apply to appeals from temporary commitments. ind. r. app. p. 14.1 (2018). accordingly, under the usual rules of appellate procedure, the trial court reporter generally has forty-five days to file the transcript after the committed person has filed her notice of appeal. ind. r. app. p. 11(b) (2018). once the transcript has been filed, the parties then have a total of seventy-five days to file their briefs, assuming no extensions are requested or given. ind. r. app. p. 45(b) (2018). and, once the indiana court of appeals has issued its decision, no action can be taken on that decision until it is certified, which generally happens thirty days after the hand down, assuming no petitions for rehearing or transfer are filed. ind. r. app. p. 65(e) (2018). 18. in re lawrance, 579 n.e.2d 32, 37 (ind. 1991). 19. id. 20. id. (quoting ind. educ. emp’t relations bd. v. mill creek classroom teachers ass’n, 456 n.e.2d 709, 711-12 (ind. 1983)). some opinions of the indiana court of appeals refer to this exception as the “great public importance” exception. e.g., in re j.b., 766 n.e.2d 795, 799 (ind. ct. app. 2002). 21. lawrance, 579 n.e.2d at 37. 22. id. at 34. 23. in re lawrance, 579 n.e.2d 32, 36-37 (ind. 1991). 24. id. at 37. 25. id. 298 indiana health law review [vol. 15:295 many indiana citizens, health care professionals, and health care institutions expect to face the same legal questions in the future. we are also persuaded to proceed because of the high caliber of the findings and analysis in [the trial court’s] orders. in light of [the daughter’s] death, however, this court no longer need address all of the issues in the case as presented by the parties.26 the indiana supreme court has not had the occasion to apply those principles to an appeal from a temporary commitment order. however, the court of appeals has had numerous opportunities to consider the law of mootness as applied to temporary commitment appeals. in particular, on twenty-four occasions the court of appeals has considered whether an appeal from a temporary commitment order was moot.27 in in re j.b., the initial and leading opinion on the matter, the court of appeals, relying on lawrance, declared that appeals from expired temporary commitment are moot.28 however, the court went on to hold as follows: the question of how persons subject to involuntary commitment are treated by our trial courts is one of great importance to society. indiana statutory and case law affirm that the value and dignity of the individual facing commitment or treatment is of great societal concern. see ind. code § 12-26-5-1 (establishing procedures for seventy-two-hour commitment); ind. code § 12-26-6-2 (establishing procedures for ninety-day commitment); in re mental commitment of m.p., 510 n.e.2d 645, 646 (ind. 1987) (noting that the statute granting a patient the right to refuse treatment “profoundly affirms the value and dignity of the individual and the commitment of this society to insuring humane treatment of those we confine”). the instant case involves the proof necessary for involuntary commitment . . . th[is is an issue] of great public importance and [is] likely to recur, so we will address [it] here.29 thus, the court of appeals reached the merits of the question on appeal under the great public interest exception to the general rule that moot cases will be dismissed. the court of appeals’ analysis in j.b. has been followed in nearly every subsequent temporary commitment appeal. in eleven of those subsequent appeals, the court of appeals concluded in a for-publication opinion that the validity of the temporary commitment was a moot question on appeal but, nonetheless, the 26. id. (quoting city of jeffersonville v. louisville & jeffersonville bridge co., 83 n.e. 337, 340 (ind. 1908)). 27. this number is based on a westlaw search of all indiana case law using the terms “commitment” and “moot!,” which returned 178 cases as of february 26, 2018. of those 178 cases, seventy-four were civil appeals. of those seventy-four cases, twenty-four were temporary commitment appeals that discussed the law of mootness. 28. in re j.b., 766 n.e.2d 795, 798 (ind. ct. app. 2002). 29. id. at 798-99. 2018] collateral consequences and the right to appeal 299 great public interest exception justified reaching the merits of the issue on appeal.30 on twelve occasions, the court of appeals undertook an identical analytical approach but in a not-for-publication memorandum decision,31 even though indiana appellate rule 65(a) states that an opinion of the court of appeals “shall be published . . . if the case . . . involves a legal or factual issue of . . . substantial public importance.”32 on only one occasion has the court of appeals dismissed an appeal from a temporary commitment order as moot.33 in that appeal, only the appellant had filed a brief for the court of appeals to review, and the court of appeals based its decision to dismiss the appeal on its inability to conduct “a more thorough 30. m.l. v. eskenazi health/midtown mental health cmhc (in re m.l.), 80 n.e.3d 219, 222 (ind. ct. app. 2017); m.e. v. dep’t of vet. affairs (in re m.e.), 64 n.e.3d 855, 859 n.3 (ind. ct. app. 2016); in re j.m., 62 n.e.3d 1208, 1210 (ind. ct. app. 2016); r.p. v. optional behav. mhs (in re r.p.), 26 n.e.3d 1032, 1035 (ind. ct. app. 2015); t.k. v. dep’t. of vet. affairs (in re t.k.), 993 n.e.2d 245, 247-48 (ind. ct. app. 2013); g.q. v. branam, 917 n.e.2d 703, 706 (ind. ct. app. 2009); bradbury v. comprehensive mental health servs. (in re bradbury), 845 n.e.2d 1063, 1064 n.1 (ind. ct. app. 2006); m.z. v. clarian health partners (in re m.z.), 829 n.e.2d 634, 637 (ind. ct. app. 2005); m.m. v. clarian health partners (in re m.m.), 826 n.e.2d 90, 94 n.3 (ind. ct. app. 2005); in re steinberg, 821 n.e.2d 385, 387 n.2 (ind. ct. app. 2004); golub v. giles (in re golub), 814 n.e.2d 1034, 1036 n.1 (ind. ct. app. 2004). 31. in re s.c., 49a04-1608-mh-1802, 2017 wl 410233, at *1 n.2 (ind. ct. app. jan. 31, 2017); h.f. v. eskenazi health, no. 49a02-1602-mh-335, 2016 wl 4585868, at *2 (ind. ct. app. sep. 2, 2016); r.s. v. gallahue mental health servs. (in re r.s.), no. 49a02-1405-mh-357, 2015 wl 143988, at *1 (ind. ct. app. jan. 12, 2015); g.m. v. columbus reg’l hosp. mental health facility (in re g.m.), no. 03a01-1312-mh-533, 2014 wl 4181719, at *1 n.1 (ind. ct. app. aug. 25, 2014); e.l. v. ind. univ. health bloomington hosp. (in re e.l.), no. 53a01-1402-mh-66, 2014 wl 3906078, at *2 (ind. ct. app. aug. 11, 2014); n.f. v. wishard health servs., no. 49a021304-mh-306, 2013 wl 6795118, at *2 (ind. ct. app. dec. 23, 2013); s.i. v. midtown cmhc (in re s.i.), no. 49a05-1304-mh-146, 2013 wl 5533143, at *2 (ind. ct. app. oct. 7, 2013); t.s. v. vet. affairs med. ctr. (in re t.s.), no. 49a02-1009-mh-990, 2011 wl 1483745, at *1 n.1 (ind. ct. app. apr. 19, 2011); j.g. v. cmty. hosp. n./gallahue mental health servs. (in re j.g.), no. 49a02-1008-mh-835, 2011 wl 379414, at *2 n.1 (ind. ct. app. feb. 7, 2011); e.l. v. wishard health servs. (in re e.l.), no. 49a02-0707-cv-549, 2008 wl 352199, at *2 n.1 (ind. ct. app. feb. 11, 2008); in re m.p., no. 57a03-0708-cv-407, 2008 wl 162792, at *2 n.1 (ind. ct. app. jan. 17, 2008); in re r.k., no. 49a05-0701-cv-14, 2007 wl 3132701, at *2 n.1 (ind. ct. app. oct. 29, 2007). 32. this is not to suggest that the court of appeals was incorrect in its publication decision of those twelve appeals. indeed, the court’s decision to not publish those decisions is understandable because the legal issues and fact patterns of many of those appeals would have added little, if anything, to indiana’s existing body of law if the decisions had been published. see ind. r. app. p. 65(a); compare j.m., 62 n.e.3d at 1210-11, with j.b., 766 n.e.2d at 799-800. 33. e.l. v. ind. univ. health bloomington hosp. (in re e.l.), no. 53a05-1311-mh-571, 2014 wl 2567152, at *2 (ind. ct. app. june 9, 2014). 300 indiana health law review [vol. 15:295 review” in light of that fact.34 in reaching its conclusion, the court expressly acknowledged that the appeal was, nonetheless, “[a]n issue . . . of great public importance.”35 and, as a not-for-publication memorandum decision, the court’s decision has no precedential value.36 in sum, in a typical appeal from a temporary commitment order, the court on appeal will hold that the appeal is moot. however, instead of dismissing the appeal, the court will routinely reach the merits under the great public interest exception. iv. problems with the current approach to appellate review of temporary commitments the analytical approach pervasive in indiana’s temporary commitment appeals is problematic. again, the analytical approach in these appeals began with j.b. and has been routinely followed since. in j.b., the court categorically declared that an appeal from an expired temporary commitment is moot but, nonetheless, may be considered on its merits because “[t]he question of how persons subject to involuntary commitment are treated by our trial courts is one of great importance to society.”37 the analytical framework established by the court in j.b. presents three critical problems. first, the j.b. court’s assessment that expired temporary commitment appeals are moot because the court on appeal cannot “render effective relief” to the appellant is not clearly correct.38 to be sure, the court of appeals cannot order an end to an already expired commitment. but the relief the court may grant to an appellant is not so limited.39 for example, should the court determine that a commitment order was incorrectly entered, the court may direct that that commitment be removed from the appellant’s court and medical records.40 such collateral relief could be meaningful to an appellant. in other contexts, the indiana supreme court has held that the potential for “harmful collateral consequences” is enough to avoid having an appeal being declared moot.41 for example, in s.d., the court considered whether a child-in-need-of-services (“chins”) appeal was moot when the child had been returned to the parent’s care and the chins case had been closed.42 the court held that the appeal was not moot.43 in reaching its holding, the court emphasized that “a chins finding can relax the state’s burden for terminating parental rights” if the state were to 34. id. at *4. 35. id. 36. ind. r. app. p. 65(d) (2018). 37. in re j.b., 766 n.e.2d 795, 798 (ind. ct. app. 2002). 38. id. 39. see ind. r. app. p. 66(c)(10) (2018). 40. see, e.g., id. 41. in re s.d., 2 n.e.3d 1283, 1290 (ind. 2014). 42. id. 43. id. 2018] collateral consequences and the right to appeal 301 one day seek that option against the parent.44 the court also noted that “a prior chins finding may have adverse job consequences . . . , such as precluding [a parent] from employment with any [department of child services] contractor.”45 further, such a finding might prohibit a parent “from becom[ing] a licensed foster parent.”46 thus, while reversal of the chins adjudication would not change the child’s placement or the case’s status, “[r]eversal . . . still afford[ed the parent] meaningful relief by lifting those collateral burdens.”47 accordingly, the court held that the appeal was not moot.48 similarly, in temporary commitment appeals the court of appeals has explained that a “history of mental illness requiring hospitalizations” is probative of whether a person is “gravely disabled and should be involuntarily committed.”49 indeed, in numerous temporary commitment appeals the court of appeals has discussed the appellant’s history of involuntary commitments.50 appellees, in defending orders for temporary commitments, have likewise argued that a history of involuntary commitments is relevant information for the court on appeal to consider.51 practice guides also recognize that a “history of mental illness requiring hospitalizations” has been found to support subsequent involuntary commitments.52 and this is to say nothing of any social stigma that might accompany a valid order of temporary commitment.53 thus, the j.b. court’s assessment that expired temporary commitment appeals are moot because the court on appeal cannot order the end to an already expired commitment is unnecessarily restrictive of the court’s authority to grant relief on appeal and does not take into account the potential for harmful collateral consequences that may arise from a record of temporary commitments. second, by routinely following the j.b. court’s declaration that expired temporary commitment appeals are moot but nonetheless subject to review under the great-public-interest exception, indiana’s appellate courts have misapplied 44. id. 45. id. 46. in re s.d., 2 n.e.3d 1283, 1290 (ind. 2014). chins proceedings, like temporary commitment proceedings, are confidential by statute. see ind. code § 31-39-1-2 (2017). 47. s.d., 2 n.e.3d at 1290. 48. id. 49. golub v. giles, 814 n.e.2d 1034, 1039 (ind. ct. app. 2004). 50. e.g., h.f. v. eskenazi health, no. 49a02-1602-mh-335, 2016 wl 4585868, at *1 (ind. ct. app. sept. 2, 2016); r.s. v. gallahue mental health servs. (in re r.s.), no. 49a02–1405–mh–3572015, 2015 wl 143988, at *1 (ind. ct. app. jan. 12, 2015). 51. e.g., t.s. v. logansport state hosp. (in re t.s.), no. 79a05-1406-mh-260, 2014 wl 7402136, at *11-12 (ind. ct. app. nov. 10, 2014). 52. 19 ind. l. encyclopedia mental health § 12. 53. to be sure, under indiana law a committed person’s mental health records are confidential. ind. code § 16-39-2-3 (2016). and, to protect the committed person’s identity, indiana’s appellate courts refer to the person committed only by her initials. e.g., j.m. v. ne. ctr., inc. (in re j.m.), 62 n.e.3d 1208, 1208 (ind. ct. app. 2016). 302 indiana health law review [vol. 15:295 indiana’s mootness doctrine and allowed an exception to swallow the rule. the rule in moot cases is that the case “will be dismissed.”54 the exception for cases of great public interest might justify a case of first impression, such as in lawrance, but that limited exception does not justify excluding in perpetuity an entire class of cases from being dismissed as moot.55 in other words, if the j.b. court’s declaration that appeals from expired temporary commitments are necessarily moot was correct, a practitioner would expect to see the vast majority of those appeals dismissed. but that is not how indiana’s appellate courts routinely decide such appeals. rather, as twenty-three of the twenty-four post-j.b. opinions and memorandum decisions of the indiana court of appeals demonstrate, the court instead routinely reaches the merits of the appeal under the great-public-interest exception regardless of the actual facts or legal issues presented by an appellant. thus, the great-public-interest exception has swallowed the rule to dismiss moot appeals when the appellant is appealing an expired temporary commitment. third, the conclusion that expired temporary commitment appeals are categorically moot is problematic because, if indiana’s appellate courts were to apply to these appeals the rule that moot appeals are to be dismissed, persons who have been temporarily committed would be denied their right, through no fault of their own, under article 7, section 6 of the indiana constitution to one appeal. article 7, section 6 protects “in all cases an absolute right to one appeal.” as the indiana supreme court has explained, “indiana is particularly solicitous of the right to appeal,”56 and “hoosiers consider the right to an appeal one of the tools indispensable to meaningful participation in the judicial process.”57 but one’s right to an appeal “would mean little if it could be short-circuited” by operation of law before the appeal is complete.58 indeed, indiana’s case law under article 7, section 6 strongly suggests that review of the merits of temporary commitment appeals is preserved notwithstanding the expiration of the commitment. in galloway v. state, the indiana supreme court explained that “[a]n impossible standard of review under which appellate courts merely ‘rubber stamp’ the fact finder’s determinations, no matter how unreasonable, would raise serious constitutional concerns because it would make the right to an appeal illusory.”59 similarly, the indiana supreme court has held that court-imposed financial barriers to a party’s access to the appellate process cannot deprive that party of his constitutional right to one appeal.60 holding that expired temporary commitment appeals are always moot is not consistent with article 7, section 6. such a holding, in effect, insulates an entire 54. in re lawrance, 579 n.e.2d 32, 37 (ind. 1991). 55. see, e.g., id. 56. c.a.b. v. j.d.m. (in re c.b.m.), 992 n.e.2d 687, 692 (ind. 2013). 57. campbell v. criterion grp., 605 n.e.2d 150, 158 (ind. 1992). 58. c.b.m., 992 n.e.2d at 692. 59. galloway v. state, 938 n.e.2d 699, 709 (ind. 2010). 60. campbell, 605 n.e.2d at 157-58. 2018] collateral consequences and the right to appeal 303 class of trial court judgments, no matter how unreasonable a particular judgment may be, from appellate review. this does more than “make the right to an appeal illusory”;61 it wholly denies the right for that class of cases. as the indiana supreme court stated in galloway, such a standard “would raise serious constitutional concerns” under article 7, section 6.62 further, the basis for the expiration of the temporary commitment prior to the appeal is a predetermined standard of the indiana general assembly, not a personal waiver or failure to act.63 for purposes of appellate review, the time limitations imposed by our involuntary commitment statutes are analogous to financial barriers to court access imposed by court rule. that is, the fact that an appellant cannot afford the court-required costs of having the record transcribed is not a basis for denying her right to appeal.64 similarly, that one cannot obtain, as a practical matter, appellate review of a temporary commitment before the statutory expiration of the ninety days ought not be a basis for denying the appellant her right to appellate review of that judgment. accordingly, insulating temporary commitments from appellate review by categorically declaring them moot raises serious concerns under article 7, section 6. in sum, the current analytical approach of indiana’s appellate courts to temporary commitment appeals is suspect. the case on which the current approach is premised, j.b., does not seem to account for potentially harmful collateral consequences from temporary commitments. further, the j.b. court’s analysis has resulted in an exception to the mootness doctrine swallowing the rule that such appeals will be dismissed. and, finally, the j.b. court’s approach is constitutionally suspect as it suggests that persons who are subject to temporary commitments are not entitled to their right to one appeal under article 7, section 6 of the indiana constitution. v. a way forward indiana’s appellate courts should reconsider the analytical framework in which temporary commitment appeals are decided. the current analytical approach has not clearly accounted for harmful collateral consequences, has created an exception that has swallowed the general rule for moot cases, and is 61. galloway, 938 n.e.2d at 709. 62. id. 63. cf. clark v. state, 506 n.e.2d 819, 821 (ind. 1987) (holding that one may waive the right to one appeal under article 7, section 6). this could also plausibly be viewed as a problem created by indiana’s rules of appellate procedure as the expedited appeals process outlined in indiana appellate rule 14.1 does not apply to ninety-day temporary commitments. see ind. r. app. p. 14.1 (2018). however, even if rule 14.1 were amended to apply to temporary commitments, or if temporary commitment appeals were otherwise routinely expedited, it is difficult to envision a rule amendment or other expedited process that would capture twenty-four-hour or seventy-two-hour detentions. 64. see campbell v. criterion grp., 605 n.e.2d 150, 157-58 (ind. 1992). 304 indiana health law review [vol. 15:295 constitutionally suspect. a better approach would be for indiana’s appellate courts to declare that temporary commitment appeals are not moot for one of two reasons, or both. first, the fact of a temporary commitment carries with it potentially harmful collateral consequences. the indiana supreme court has made it clear that such consequences are sufficient to avoid having an appeal declared moot in indiana.65 as such, the current analytical approach should be replaced by an approach that recognizes the potential for harmful collateral consequences that may arise from temporary commitments. under that approach, appeals from expired temporary commitments are not moot.66 second, declaring all temporary commitment appeals moot denies those appellants their right to one appeal, which is protected under article 7, section 6 of the indiana constitution. stated another way, article 7, section 6 prohibits temporary commitment appeals from being declared moot as a class. thus, in lieu of or in addition to recognizing the potential for harmful collateral consequences, the current analytical approach should be replaced by an approach that ensures that the appellant in an expired temporary commitment appeal receives her protected right to one appeal. in sum, temporary commitment appeals are not moot, and indiana’s appellate courts should undertake a new analytical framework to these appeals. 65. in re s.d., 2 n.e.3d 1283, 1290 (ind. 2014). 66. see id. indiana health law review volume xvii 2020 number 2 notes indiana medicaid: hope amid a crisis emily s. beukema* there’s all sorts of trauma from drama that children see, type [] that normally would call for therapy. but you know just how it go in our community, keep [it] inside it don’t matter how hard it be.1 i. introduction: the crisis the rise in substance misuse in the united states has been neither quiet nor subtle. in 2017, the u.s. department of health and human services (hhs) declared a public health emergency in response to the named “opioid crisis” and overdose epidemic, with an estimated 130 deaths per day or more from opioidrelated drug overdoses.2 the substance misuse crisis has led both traditional and nontraditional healthcare stakeholders to take action. for example, in october 2018, the united states witnessed president trump sign the substance-use disorder prevention that promotes opioid recovery and treatment for patients and communities (support) act into law.3 this was just months after three hip-hop/rap albums were released speaking out on substance misuse and mental health,4 including one artist who dedicated their entire album to the consequences of youth either around or involved in substance abuse.5 around this same time, in june of 2018, timothy hill, the acting director for the center for medicaid * jd, mph candidate 2020, indiana university robert h. mckinney school of law, indiana university richard m. fairbanks school of public health. 1. j. cole, friends, on kod (interscope records, roc nation, and dreamville records 2018). 2. what is the u.s. opioid epidemic?, u.s. dep’t health & hum. servs., https://www.hhs.gov/opioids/about-the-epidemic/index.html [https://perma.cc/h2db-y45u]. 3. marybeth musumeci & jennifer tolbert, federal legislation to address the opioid crisis: medicaid provisions in the support act, kaiser fam. found. (oct. 5, 2018), https://www.kff.org/medicaid/issue-brief/federal-legislation-to-address-the-opioid-crisis-medicaidprovisions-in-the-support-act/ [https://perma.cc/s62r-9dge]. 4. see generally j. cole, kod (interscope records, roc nation, and dreamville records 2018); kid cudi & kanye west, kids see ghosts (good & def jam 2018); kanye west, ye (good & def jam 2018). 5. j. cole, supra note 4. https://www.kff.org/medicaid/issue-brief/federal-legislation-to-address-the-opioi https://www.kff.org/medicaid/issue-brief/federal-legislation-to-address-the-opioi 184 indiana health law review [vol. 17:183 and children’s health insurance program (chip) services, stressed that neonatal abstinence syndrome (nas), a withdrawal syndrome suffered by infants exposed to opioids during pregnancy,6 is a “significant and rapidly growing public health concern . . . directly related to the opioid crisis facing this country.”7 to put it in perspective, the u.s. saw a more than a five-fold increase of babies born with nas the u.s. from 2000 to 2012.8 what led musicians and other leaders to push the spotlight onto the children involved in this “wicked problem”9—the substance abuse crisis? perhaps it is a growing recognition of the future health risks for children born with nas. for example, a ground-breaking study looked at the impact traumatic childhood experiences have on future health outcomes across an individual’s lifespan.10 each defined experience is now known as an adverse childhood experience (“ace”),11 and unfortunately, babies born with nas have already been exposed to at least one ace, and some have likely been exposed to more than one ace based on the data available related to pregnant mothers who use opioids.12 aces 6. jean y. ko et al., morbidity and mortality weekly report: incidence of neonatal abstinence syndrome—28 states, 1999-2013, 65 morbidity & mortality wkly. rep. (mmwr) 799, 799 (2016), https://www.cdc.gov/mmwr/volumes/65/wr/mm6531a2.htm?s_cid=mm6531a2_w [https://perma.cc/uf4k-xdyv]. 7. timothy b. hill, cmcs informational bulletin neonatal abstinence syndrome: a critical role for medicaid in the care of infants, u.s. dep’t health & hum. servs. (june 11, 2018), https://www.medicaid.gov/federal-policy-guidance/downloads/cib060818.pdf [https://perma.cc/br46-rfz9]. 8. dramatic increases in maternal opioid use and neonatal abstinence syndrome, nat’l inst. on drug abuse (jan. 2019), https://www.drugabuse.gov/related-topics/trends-statistics/ infographics/dramatic-increases-in-maternal-opioid-use-neonatal-abstinence-syndrome [https://perma.cc/3yzy-cg8y]. 9. see jonathan c. lee, the opioid crisis is a wicked problem, 27 am. j. on addictions 51, 51 (2017) (describing the opioid overdose epidemic as an “endemic complex system[] with components that interact in complicated, poorly understood and unpredictable ways” and as “impossible to establish a single locus . . .”). 10. see generally v. j. felitti et al., relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults, 14 am. j. preventative med. 245 (1998). 11. id. at 245, 250 (defining ace categories to include psychological abuse, physical abuse, sexual abuse, substance abuse in the household, mental illness in the household, mother treated violently in the household, and criminal behavior in the household). 12. preventing adverse childhood experiences, ctrs. for disease control & prevention, https://www.cdc.gov/violenceprevention/childabuseandneglect/aces/fastfact.html? cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fviolenceprevention%2fchildabuseandn eglect%2facestudy%2faboutace.html [https://perma.cc/4a7g-278z] (one definition of an ace is household substance abuse. accordingly, every child born with nas already has a score of one just from being born because of the mother exposing to substances in utero). see sylvia paull, aces histories for mothers recovering from substance abuse, aces too high (dec. 27, 2015), https://acestoohigh.com/2015/12/27/aces-histories-for-mothers-recovering-from-substance-abuse https://www.cdc.gov/mmwr/volumes/65/wr/mm6531a2.htm?s_cid=mm6531a2_w https://www.medicaid.gov/federal-policy-guidance/downloads/cib060818.pdf 2020] indiana medicaid: hope amid a crisis 185 have been found to have an impact on neurodevelopment and link individuals to the leading causes of death in the u.s., such as obesity, smoking, alcohol abuse, and substance abuse.13 additionally, there is an increased risk for adverse health outcomes as the number of aces increases.14 substance abuse in the household, a circumstance children born with nas unfortunately often find themselves in, is defined as an ace.15 this note seeks to demonstrate that the only way of solving this “wicked”16 problem is to end the cycle of substance abuse by public health policy interventions. this note will further offer attainable solutions at the policy level, specifically through indiana’s medicaid program. the medicaid program is an excellent point of intervention because nas newborns are more likely to be enrolled in medicaid programs versus private insurance.17 this note seeks to explain why the indiana medicaid program is not currently optimized to equip infants born with nas with the best chance for positive health outcomes and rather is providing a barrier in efforts to end the familial cycle of substance misuse in the united states.18 ii. background a. the crisis’ impact on indiana compared to other states, indiana is disproportionately affected by the current national opioid crisis and has shown no sign of slowing. in 2017, there was a national ten percent increase in overdoses caused by opioids while indiana saw an eighteen percent increase,19 seeing its highest ever number of drug overdose [https://perma.cc/2vcg-cq6x] (describing how a small residential program in tennessee for new mothers and their infants recovering from substance abuse conducted a survey and found these mothers had an ace score average of about 6); mohamed e. abdel-latif et al, profile of infants born to drug-using mothers: a state-wide audit, 49 j. pediatrics & child health, e80 (2012) (explaining many of the infants born with nas have parents with a mental illness, a characteristic considered to be an ace). 13. see felitti et al., supra note 10, at 254. 14. see id. 15. see id. at 248. 16. see lee, supra note 9, at 51. 17. khaleel s. hussaini & luigi f. garcia saavedra, neonatal abstinence syndrome (nas) in southwestern border states: examining trends, population correlates, and implications for policy, 22 maternal & child health j. 1352, 1355 (2018). 18. see about the cdc-kaiser ace study, ctrs. for disease control & prevention, https://www.cdc.gov/violenceprevention/childabuseandneglect/acestudy/about.html [https://perma.cc/4a7g-278z] (under ace definitions, defining one ace as having a household member with a substance use disorder. under major findings, aces increase the risk for adverse health outcomes including substance abuse). 19. f. b. ahmad et al., provisional drug overdose death counts, ctrs. for disease control & prevention (2018), https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm 186 indiana health law review [vol. 17:183 deaths in one year.20 approximately one in twelve indiana residents (almost half a million people) meet the criteria for having a substance use disorder (sud)21 with nearly four thousand indiana residents having died from opioids within the last decade.22 unsurprisingly, trends in nas have correlated to the rise in sud.23 in the us, the “incidence of nas has sharply increased from 1.19 per 1000 births in 2000, to 5.63 per 1000 births in 2012.”24 while data tracking nas trends has historically been somewhat inconsistent in indiana,25 the indiana state department of health began an initiative to collect data on nas in 2016, expanding the range of hospitals since.26 subsequent to this initiative, data collected from 2016 to 2017 showed about sixteen percent of newborns tested at participating hospitals were exposed to opioids during their mother’s pregnancy.27 additionally, data on national trends and corresponding medicaid spending provides further insight into how nas is burdening indiana. national data demonstrates rural infants are disproportionately affected nearly seven-fold as compared to urban infants,28 and indiana notably has a higher rural population percentage than the national average.29 [https://perma.cc/pbh6-zfe7]. 20. lincoln wright, indiana overdose deaths in 2017 reach record high, south bend trib. (aug. 24, 2018), https://www.southbendtribune.com/news/publicsafety/indiana-overdosedeaths-in-reach-record-high/art icle_68edd5ef-f168-5d10-b34f-5c4b5b7f8e13.html [https://perma.cc/cf6g-bxt5] 21. harold kooreman & marion greene, treatment & recovery for substance use disorders in indiana (lyndy kouns ed., 2016), https://fsph.iupui.edu/doc/researchcenters/treatment%20and%20recovery%202016.pdf [https://perma.cc/3b4t-zdxa]. 22. bob segall, so many bodies: indiana coroners trying to keep up with opioid epidemic, wthr (nov. 15, 2017, 7:14 pm), https://www.wthr.com/so-many-bodies-indiana-corners-tryingto-keep-up-with-opioid-epidemic [https://perma.cc/6gt5-td3e]. 23. see comm. on obstetric practice, acog committee opinion number 711: opioid use and opioid use disorder in pregnancy, am. college of obstetricians & gynecologists, am. soc. of addiction med. 2 (aug. 2017), httpd://acog.org/clinical-guidance-and-publications/ committee-opinions/committee-on-obsteric-practice-/opioid-use-and-opioid-use-disorder-inpregnancy?ismobileset=falses [https://perma.cc/87bv-zb4l]. 24. lauren a. sanlorenzo et al., neonatal abstinence syndrome: an update, 30 current opinion pediatrics 182, 184 (2018). 25. see maureen groppe, data show high rate of opiate-affected newborns, indy star (aug. 13, 2016, 3:02 pm), www.indystar.com/story/news/2016/08/13/data-show-high-rate-opiateaffected-newborns/88561134 [https://perma.cc/a97q-zram] (describing indiana’s new initiative to improve data collection methods on nas). 26. associated press, indiana agency collects data on neonatal abstinence syndrome, wash. times, (dec. 23, 2017), https://www.washingtontimes.com/news/2017/dec/23/indianaagency-collects-data-on-neonatal-abstinenc/ [https://perma.cc/x2uv-geuv]. 27. id. 28. sanlorenzo et al., supra note 24, at 2. 29. see brigitte s. waldorf, what is rural and what is urban in indiana? (2007), 2020] indiana medicaid: hope amid a crisis 187 nationally, eighty percent of the $1.5 billion spent on caring for infants with nas was paid for by medicaid.30 indiana medicaid has spent $23.7 million to treat 1,616 infants born with nas since october 1, 2015.31 these figures not only provide insight on how indiana infants are significantly affected but they also provide insight on how medicaid can potentially aid as a tool; a tool to both improve this population’s health outcomes and work toward ending the current substance misuse crisis. the subsequent sections of this note will proceed by discussing the health problems associated with this population of infants born with nas, followed by the structure of indiana’s medicaid program and a discussion of why it is not currently optimized to provide this population with the best chance for a healthy future. b. neonatal abstinence syndrome and its health implications short-term effects of nas put infants at an increased risk for serious health complications, even death, if not properly treated.32 opioid-exposed infants born and those subsequently diagnosed with nas are at an increased risk for premature birth and low birth weight, including the complications that go along with those conditions.33 additionally, these infants are more likely to suffer from respiratory distress, problems feeding, seizures, jaundice, irritability, tremors, hyperthermia as well as the complications associated with those conditions.34 infants born with nas also demonstrate unusual social and behavioral characteristics, often contributing to the difficulty in treating their condition.35 additionally, infants born with nas are at an increased risk for a variety of adverse long-term health problems as they develop through childhood into adulthood. regarding the cognitive health risks, nas puts infants at an increased risk for future developmental delays including social, emotional, intellectual,36 https://pcrd.purdue.edu/files/media/what-is-rural-and-what-is-urban-in-indiana.pdf [https://perma.cc/39wg-xaa8]. 30. s.w. patrick et al., increasing incidence and geographic distribution of neonatal abstinence syndrome: united states 2009-2012, 35 j. perinatology 650, table 1 (2015). 31. giles bruce, babies are being born addicted to opioids in indiana at alarming rates. help isn’t always available., the times (sept. 17, 2017), https://www.nwitimes.com/ news/special-section/opioids-in-nwi/babies-are-being-born-addicted-to-opioids-in-indianaat/article_baa97c4c-d4f8-5f2c-b4d4-5c1fe44534e2.html [https://perma.cc/64uk-nt6p]. 32. see stephen w. patrick et al., prescription opioid epidemic and infant outcomes, 135 pediatrics 842, 847 (may 2015). 33. see id. at 844. 34. id. megan w. stover & jonathan m. davis, opioids in pregnancy and neonatal abstinence syndrome, 39 seminars perinatology 561, 562 (2015). 35. see mohamed e. abdel-latif, supra note 12, at e84. 36. see stephanie l. merhar et al., retrospective review of neurodevelopmental outcomes in infants treated for neonatal abstinence syndrome, 38 j. perinatology 587 (2018). 188 indiana health law review [vol. 17:183 and behavioral delays.37 the increased risk of physical outcomes include comorbidities and suboptimal outcomes such as visual38 and motor abnormalities, torticollis and plagiocephaly, and exposure to the hepatitis c virus.39 further, consistent with what we know regarding aces40 and future health risks associated with nas, children with parents who have a substance abuse disorder are at an increased risk of developing a substance use disorder themselves, thereby risking a replication of the same cycle with themselves and their own future children.41 c. indiana medicaid program and waiver system as previously mentioned, data on indiana’s medicaid spending offers insight as to why medicaid has the potential to be one of the best, most attainable policy interventions in the growing nas and substance abuse crisis. indiana medicaid has spent $23.7 million to treat 1,616 infants born with nas since october 1, 2015.42 as discussed previously, data show children born with nas will likely rely on medicaid for their healthcare needs.43 unfortunately, data based on aces and nas indicates indiana medicaid is not currently optimized to provide children born with nas with the healthcare they will likely need in order to have the best chance for a healthy future. previously discussed, babies born with nas are at an increased risk of developing a variety of adverse health outcomes in the future, affecting both physical and mental health.44 indiana has three medicaid options for children.45 as of 2018,46 each medicaid program now offers both substance abuse treatment 37. eric s. hall et al., developmental disorders and medical complications among infants with subclinical intrauterine opioid exposures, 22 population health mgmt. 19, 22 (2018). 38. merhar, supra note 36, at 591. 39. hall, supra note 37, at 19. 40. see about the cdc-kaiser ace study, ctrs. for disease control & prevention, https://www.cdc.gov/violenceprevention/childabuseandneglect/acestudy/about.html (under aces definitions, defining one ace as having a household member with a substance use disorder); see also about the cdc-kaiser ace study, centers for disease control and prevention, https://www.cdc.gov/violenceprevention/childabuseandneglect/acestudy/about.html (under major findings, aces increase the risk for adverse health outcomes including substance abuse). 41. anthony nagle & gill watson, parental substance misuse: an islington perspective, 17 child abuse rev. 444, 445 (2008); kathleen r. merikangas et al., psychopathology among offspring of parents with substance abuse and/or anxiety disorders: a hight-risk study, 39 j. child psychol. & psychiatry 711, 712 (1998). 42. bruce, supra note 31. 43. patrick et al., supra note 32, at 652. 44. see generally nagle & watson, supra note 41; merikangas et al., supra, note 41; merhar, et al., supra note 36. 45. ind. medicaid for members., children, in.gov (2019), https://www.in.gov/medicaid/ members/218.htm [https://perma.cc/nt7g-rt87]. 46. see letter from eric j. holcomb, governor of ind., to norris cochran, sec’y of the dep’t. 2020] indiana medicaid: hope amid a crisis 189 and mental health treatment to all indiana medicaid members whereas, in the past, only certain plans offered certain services.47 these types of services are those that individuals born with nas are at an increased chance of needing some time in the future.48 this attempt to improve access to mental health and substance abuse services was a major improvement through the hip 2.0 program,49 however, indiana will have to make additional changes in order to maximize the potential benefits of expanding access to treatment. indiana notoriously, and consistently falls behind in national healthcare rankings. a 2016 report ranked indiana 45 out of 51 (including all 50 states and the district of columbia) on the state’s mental healthcare status, the lower ranking indicating a higher prevalence of a qualifying mental illness and a low rate of access to care.50 the 2017 u.s. news & world report ranked indiana 40 out of 50 overall for general state healthcare rankings, taking into consideration access, quality, and public health services.51 it might seem that the newly amended indiana medicaid program will solve the issues surrounding lack of mental health and substance abuse treatment accessibility, however, there are deeper issues and it is unclear whether indiana is willing to fix them. healthcare accessibility goes beyond what services a healthcare plan will cover. there has to be a workforce behind those services. currently, there is a severe shortage of mental health and addiction specialists,52 services individuals of health and human servs., (jan. 31, 2017), https://www.in.gov/fssa/hip/files/hip_2_0_letter.pdf [https://perma.cc/dq5f-69ah]. 47. ind. medicaid for members, what is covered by indiana medicaid?, in.gov, https://www.in.gov/medicaid/members/297.htm [https://perma.cc/9zxu-szgm]. sarah fentem, state will now cover more addiction treatment for hoosiers on medicaid, side effects public media, wfyi indianapolis (feb. 11, 2018), http://www.sideeffectspublicmedia.org/post/statewill-now-cover-more-addiction-treatment-hoosiers-medicaid [https://perma.cc/ka2d-7qet]. 48. see generally nagle & watson, supra note 41; merikangas et. al., supra note 41; merhar et al., supra note 36. 49. see maureen groppe, who will benefit from indiana’s hip 2.0?, indystar (jan. 27, 2015, 11:59 am), https://www.indystar.com/story/news/2015/01/27/will-benefit-expansionindianas-medicaid-alternative/22403479/ [https://perma.cc/s5c5-8jpf] (explaining indiana’s experimental program in expanding medicaid). 50. reports highlight mental health treatment concerns in indiana, options behav. health sys., https://www.optionsbehavioralhealthsystem.com/about/indiana-communityresources/indianas-mental-health-crisis/ [https://perma.cc/h8lz-6fs5]. see also ranking the states, mental health america, http://www.mentalhealthamerica.net/issues/ranking-states [https://perma.cc/8e9n-d8m9]. 51. health care rankings. measuring how well states are meeting citizens’ health care needs, u.s. news & world rep., https://www.usnews.com/news/best-states/rankings/health-care [https://perma.cc/la2q-ly8q]. 52. christine vestal, how severe is the shortage of substance abuse specialists?, pew charitable trusts (apr. 1, 2015), https://www.pewtrusts.org/en/research-and-analysis/blogs/ stateline/2015/4 /01 /how-severe -is -t h e -sh or t age-of-substance-abuse-specialists [https://perma.cc/b6g7-7dqg]. 190 indiana health law review [vol. 17:183 born with nas are at an increased risk of needing.53 nationally, behavioral health specialists trained to work with individuals with substance use disorders, including psychiatrists, psychologists, and counselors have an availability on average of 32 behavioral health specialists per 1,000 people affected by a mental health and/or substance use disorder; in indiana, that number is just under 20 specialists per 1,000 affected.54 the main reasons attributed to this shortage are the stigma associated with the sud population and poor pay.55 physicians, psychologists, and counselors in the behavioral health field have considerably smaller salaries compared to their counterparts in other specialties that require the same amount of education and training.56 this lower salary is a result of notoriously low reimbursement rates from state governments for mental health and substance abuse treatment services.57 medicaid, including chip, covers about 74 million people (about 24%) of the u.s. population.58 states participating in medicaid provide eligible individuals coverage for medical services and the federal government matches the state’s medicaid payments to the program based on the current federal medical assistance percentage (“fmap”).59 the fmap for a state will always be in a range of 50% 83% federal matching per state dollar spent,60 and “takes into account the average per capita income for each [s]tate relative to the national average.”61 indiana’s current fmap, for example, is 65.83%;62 this means that the federal government will contribute 65.84% of the cost for a covered medical service for an individual, and indiana will contribute 34.16% of the cost for that service. indiana’s medicaid program covers certain services for individuals with incomes 133% below the federal poverty line, as well as pregnant women and 53. see nagle & watson, supra note 41, at 444-453. see generally merikangas et al., supra, note 41; merhar et al., supra note 36; hall et al., supra note 37, at 22. 54. vestal, supra note 52. 55. id. see also natalie jacewicz, teaching future doctors about addiction, kaiser health news (aug. 2, 2016), https://khn.org/news/teaching-future-doctors-about-addiction/ [https://perma.cc/n385-5ljl]. see also david levine, what’s the answer to the shortage of mental health care providers?, u.s. news & world rep. (may 25, 2018), https://health. usnews.com/health-care/patient-advice/articles/2018-05-25/whats-the-answer-to-the-shortage-ofmental-health-care-providers [https://perma.cc/j7fh-2rrg]. 56. vestal, supra note 52. 57. id. 58. nicole huberfeld, elizabeth weeks leonard, & kevin outterson, the law of american health care, 89 (2nd ed. 2018). 59. id. at 91-92 (explaining 42 u.s.c. § 1396(b)). 60. id. at 92 (with excerpt of 42 u.s.c. § 1396d(b)). 61. federal medical assistance percentage (fmap) for medicaid and multiplier, kaiser fam . found ., https://www.kff.org/medicaid/state-indicator/federal-matching-rate-andmultiplier/?currenttimeframe=0&sortmodel=%7b%22colid%22:%22location%22,%22sort%2 2:%22asc%22%7d [https://perma.cc/2hhp-8jq7]. 62. id. 2020] indiana medicaid: hope amid a crisis 191 children even further below this threshold.63 indiana medicaid has eight waivers which allow for reimbursement for services not traditionally covered under medicaid, opening the door for some practitioners to receive reimbursements for things like outpatient psychosocial addiction treatment,64 addiction treatment, group therapy, and other mental health services which are otherwise not covered under the general medicaid program.65 the issues with these waivers are that each waiver offers distinct services, individuals may only be enrolled in one waiver program at a time,66 and existing monetary spending caps on some of the waivers.67 individuals born with nas are at risk for needing treatment under two different indiana medicaid waiver programs based on current research on future health outcomes of this population. the first waiver, under the indiana family and social services administration (fssa)’s division of aging, is the aged & disabled (a&d) waiver.68 its purpose is to provide homeand community-based services to individuals who otherwise would require a nursing facility level of care.69 the second waiver, under the division of disability and rehabilitative services (ddrs) of the fssa, is the family supports (fs) waiver.70 this waiver provides “services to participants in a range of community settings as an alternative to care in an intermediate care facility for individuals with intellectual disabilities or related conditions.”71 notably, this waiver does not provide reimbursement for behavioral therapy and does not provide reimbursement for mental health or addiction treatment.72 the community integration and habilitation (cih) waiver under ddrs is similar to the fs waiver but serves a population that meets additional criteria relating to their diagnosis of developmental disability or intellectual disability, generally with more substantial functional limitations.73 again, however, this waiver does not provide 63. medicaid, children’s health insurance program, & basic health program eligibility levels, medicaid.gov, https://www.medicaid.gov/medicaid/program-information/medicaid-andchip-eligibility-levels/index.html [https://perma.cc/d2ws-nj5u]. 64. see procedure code 4306f (pt tlk psych & rx opd addic), outpatient fee schedule, http://provider.indianamedicaid.com/ihcp/publications/maxfee/fee_home.asp#outpatient feeschedule [https://perma.cc/f8v7-7psx] (these spreadsheets are updated over time). 65. see id. 66. maertz v. minott, no. 1:13-cv-00957-jms-mjd, 2015 u.s. dist. lexis 74084, r *3, 10 (s.d. ind. june 9, 2015). 67. steimel v. wernert, 823 f.3d 902, 907 (7th cir. 2016). 68. see family & soc. serv. admin., indiana home and community-based services waiver, in.gov, https://www.in.gov/fssa/da/3476.htm [https://perma.cc/5hlf-6dxq]. 69. steimel, 823 f.3d at 907. 70. family & soc. serv. admin., bureau of developmental disabilities services, in.gov, https://www.in.gov/fssa/ddrs/2639.htm [https://perma.cc/wu45-thxw]. 71. id. 72. see generally family & soc. serv. admin., medicaid hcbs programs, in.gov, https://www.in.gov/fssa/ompp/2549.htm [https://perma.cc/jyz2-5hrk]. 73. steimel, 823 f.3d at 907; family & soc. serv. admin., supra note 69. 192 indiana health law review [vol. 17:183 reimbursement for behavioral therapy nor does it provide reimbursement for mental health or addiction treatment. there are other indiana medicaid waivers relatively unrelated to the needs of individuals born with nas, however, they are still worth mentioning to add context and to paint a picture of a state like indiana’s medicaid system. a waiver that ended new enrollees in 2017 is the prtf transition waiver.74 individuals still on this waiver are provided behavioral health community-based care and are considered high-need children, including those that have transitioned from a psychiatric residential treatment facility to a community setting.75 relatively unrelated to this topic, there is also a traumatic brain injury waiver through fssa’s division of aging.76 potentially related to the future needs of individuals born with nas, the adult mental health habilitation (“amhh”) waiver provides community-based services for adults with “serious mental illness or co-occurring mental illness and addiction disorders.”77 to be eligible for the amhh waiver, an applicant must have an eligible primary mental health diagnosis which includes schizophrenic disorder, major depressive disorder, bipolar disorder, delusional disorder, or psychotic disorder.78 the behavioral and primary healthcare coordination (bphc) waiver provides assistance in coordinating healthcare services to manage the mental health and/or addiction and physical healthcare needs.79 to be eligible for this waiver, an individual must have a primary mental health diagnosis.80 the last waiver is the child mental health wraparound (cmhw) waiver.81 this waiver provides services to youth “with serious emotional disturbances with intensive, home and community based wraparound services.”82 there are some exclusions regarding eligibility, however, including having a primary substance use disorder, a pervasive developmental disorder, a primary attention deficit hyperactivity disorder, an intellectual disability or disabilities, or a dual diagnosis of serious emotional disturbance and intellectual disabilities.83 as hinted at above, there are several roadblocks or obstacles with indiana’s 74. see family & soc. serv. admin., psychiatric treatment residential facility (ptrf) transition waiver, in.gov, https://www.in.gov/fssa/dmha/6643.htm [https://perma.cc/bgd4ur5u]. 75. id. 76. family & soc. serv. admin., supra note 72. 77. family & soc. serv. admin., adult mental health habilitation services, in.gov, https://www.in.gov/fssa/dmha/2876.htm [https://perma.cc/bc4q-8hmu]. 78. 405 ind. admin. code § 5-21.8-4 (2020). 79. family & soc. serv. admin., behavioral and primary care coordination, in.gov, https://www.in.gov/fssa/dmha/2883.htm [https://perma.cc/d2pu-f77b]. 80. 405 ind. admin. code § 5-21.6-4 (2020). 81. family & soc. serv. admin., supra, note 72. 82. family & soc. serv. admin., child mental health and wraparound services, in.gov, https://www.in.gov/fssa/dmha/2766.htm [https://perma.cc/9nhm-bew8]. 83. 405 ind. admin. code § 5-21.7-5 (2020). 2020] indiana medicaid: hope amid a crisis 193 waiver program. waiver participants may also use services provided through indiana’s traditional medicaid,84 but again, the services required for those suffering from a mental health or substance misuse disorder generally not covered, inpatient or outpatient, under indiana’s general medicaid plan.85 additionally, some waivers have spending caps. for example, the a&d and cih waivers have no cap on services, while the fs waiver has a cap on services at $17,300 per year,86 potentially limiting the treatment individuals on those waiver programs need. further obstacles lie in the primary diagnosis restrictions regarding eligibility for each waiver program. a child prenatally exposed to opioids is given a primary diagnosis of developmental disability.87 an individual’s primary diagnosis generally does not change throughout the life course.88 if a child is later diagnosed with some other diagnoses, this becomes the secondary, tertiary (and so on) diagnosis; the primary diagnosis stays the same regardless of whether the secondary or tertiary diagnosis affects their daily lives more.89 again, qualification for participation in a waiver program is dependent on an individual’s primary diagnosis.90 for example, eligibility for the bphc waiver requires the applicant to have a primary mental health diagnosis; such as schizophrenic disorder, major depressive disorder, bipolar disorder, delusional disorder, or psychotic disorder.91 the problem lies in a child born and treated for nas 84. steimel, 823 f.3d at 907. 85. see ihcp fee schedule, in d . healt h co v er ag e pr o g r am s http://provider.indianamedicaid.com/ihcp/publications/maxfee/fee_home.asp#outpatientfeesc hedule [https://perma.cc/f9tb-dxzg] (these spreadsheets are updated over time); family & soc. serv. admin., supra, note 72. 86. family & soc. serv. admin., bureau of developmental disabilities services, in.gov, https://www.in.gov/fssa/ddrs/2639.htm [https://perma.cc/r74h-dmzf] 87. ind. state dep’t of health, annual legislative report of the indiana birth defects and problems registry 2018 3 (2018), https://www.in.gov/isdh/files/opa_approved_ 2018%20annual%20legislative%20report%20for%20ibdpr.pdf [https://perma.cc/gef4-mg53]. see generally, ind. fam. & soc. serv. admin., medicaid home and community based services rate methodology projects 3 (2019), https://www.in.gov/fssa/files/fssa_hcbs_ kickoff_webinar_march_18_19.pdf [https://perma.cc/sc6c-ujdj] (there is no authority that expressly answers the question as to why individuals born with nas are given a primary diagnosis at birth of a developmental disorder. however, it can be deduced that because the division of disabilities and rehabilitative services receives significantly more funding compared to the division of mental health and addiction, physicians are more inclined to provide a diagnosis that will allow them to be reimbursed from the division where they not only can be reimbursed, but can also receive a larger sum of reimbursement). 88. see javier meseguer, outcome variation in the social security disability insurance program: the role of primary diagnoses, 73 soc. security bull. 39, 50 (2013) (in the context of the social security administration). 89. see id. 90. see 405 i.a.c. § 5-21.8-4 (2020); see also 405 ind. admin. code § 5-21.7-5 (2020). 91. see 405 i.a.c. § 5-21.8-4. 194 indiana health law review [vol. 17:183 retaining a primary diagnosis of a developmental disability.92 generally, the fs waiver is the basic entry point to receive services for children with a developmental disability,93 and a child born with nas that was given a primary diagnosis of developmental disability will likely never, under current policies, be able to receive services under a waiver other than the fs waiver—even if they need services covered under another waiver, such as mental health or addiction treatment services—because they retain their primary diagnosis of a developmental disability, disqualifying them from receiving services under the mental health and addiction waivers. one obscurity in this issue is the reluctance of physicians to change an individual’s primary diagnosis. an interesting note is that eligibility for the waivers is determined by someone from indiana’s family and social services administration (“fssa”) and not by the individual’s primary care physician.94 to use the amhh waiver as an example, an applicant for services under this waiver would have their case reviewed by a division of mental health and addiction state evaluation team from the fssa.95 this team from the fssa would look through the applicant’s medical records and determine whether or not they meet the eligibility criteria for services under the waiver program.96 again, this waiver, which provides mental health and addiction treatment services, has primary diagnosis requirements.97 hypothetically, let us assume an individual applying for intensive mental health or substance use disorder treatments under this waiver was an individual born with nas. without a change in primary diagnosis from developmental disability to one of the qualifying mental health conditions, this hypothetical individual likely would be ineligible for this waiver’s services. the expanded mental health services available under the affordable care act has led to a heightened "crack down" on healthcare fraud and abuse prevention from the office of inspector general.98 it can reasonably be assumed this heightened focus might be preventing physicians from changing a primary diagnosis for fear of being accused of fraudulent billing practices. this offers some insight into the reluctance for a physician to change an individual’s primary diagnosis, and 92. see supra text accompanying note 88. 93. marci wheeler, indiana’s medicaid waiver programs: home and community-based services for adults and children, ind. resource ctr. for autism (2018), https://www.iidc. indiana.edu/pages/medicaid-waiver-programs-home-and-community-based-services-for-adults-andchildren [https://perma.cc/d2p9-tgxu]. 94. div. of mental health & addiction, adult mental health habilitation services 37 (2019), https://www.in.gov/medicaid/files/dmha%20amhh.pdf [https://perma.cc/ hrj7-dp2j]. 95. id. 96. id. at 37-38. 97. id. at 17. 98. see spotlight on . . . fighting fraud at community mental health centers, u.s. dep’t health & human servs., https://oig.hhs.gov/newsroom/spotlight/2013/cmhc.asp [https://perma. cc/48n9-sfm5]. 2020] indiana medicaid: hope amid a crisis 195 another is lack of reimbursement in the primary care setting for services relating to mental health.99 one additional theory offered is a detrimental psychological effect caused by a change in primary diagnosis on the individual patient.100 in sum, one waiver program does not include reimbursement for all the services these individuals will likely need, based on the research on future health risks of babies born with nas. services these individuals may need fall under two waivers,101 one of which is the fs waiver, which would cover services for behavioral and language/speech therapy, occupational therapy, in addition to therapy for developmental or cognitive delays.102 as previously mentioned, individuals born with nas are at an increased risk of developing some sort of future substance misuse disorder,103 including an opioid use disorder. because traditional indiana medicaid does not reimburse for all types of substance abuse treatment,104 an individual relying on medicaid would need to seek one of the waivers for the treatment for more intensive treatment options such as inpatient services. the waiver under which substance abuse treatment, and possibly mental health services, would be a different waiver which is available through the division of mental health and addiction as previously mentioned. for children under 19 years of age, that would be the child mental health wraparound program;105 for individuals 19-34 years of age, that would be the behavioral and primary healthcare coordination program;106 and for individuals 35 years of age or older, that would be the adult mental health habilitation services program.107 because individuals may not be on more than one waiver at a time, this cohort of individuals born with nas risk not having access to those treatments they may require based on their future health risks. currently, if we use the created hypothetical and an individual is diagnosed with a behavioral or cognitive disability, and later a mental health or substance abuse disorder, that individual would have to pick which of the issues they want to treat 99. danna mauch et al., reimbursement of mental health services in primary care settings 32 (2008), https://www.integration.samhsa.gov/reimbursement_of_mental_ health_services_in_primary_care_settings.pdf [https://perma.cc/wbv6-49j6]. 100. see jules montague, what happens when doctors change your diagnosis?, the guardian (june 11, 2018), https://www.theguardian.com/lifeandstyle/2018/jun/11/what-happenswhen-doctors-change-your-diagnosis [https://perma.cc/8mga-gdyj]. 101. see generally wheeler, supra note 93. see hall et al., supra note 37, at 20. 102. see family & soc. serv. admin., supra, note 70. 103. see generally, anthony nagle & gill watson, supra note 41; merikangas et al., supra, note 41. 104. see ihcp fee schedules, ind. medicaid, (2017), http://provider.indianamedicaid.com/ ihcp/publications/maxfee/fee_home.asp#outpatientfeeschedule, [https://perma.cc/4e8p-qkt8] (these spreadsheets are updated over time); see also family & soc. serv. admin., supra, note 72. 105. see family & soc. serv. admin., indiana youth system of care, in.gov, https://www.in.gov/fssa/dmha/2732.htm [https://perma.cc/s4td-uexl]. 106. family & soc. serv. admin., behavioral and primary healthcare coordination, in.gov, https://www.in.gov/fssa/dmha/2883.htm [https://perma.cc/9qdk-s8ec]. 107. family & soc. serv. admin., supra note 77. 196 indiana health law review [vol. 17:183 and leave the others untreated. iii. indiana medicaid as an intervention to end the opioid use crisis this new cohort of individuals, as a result of the current substance abuse crisis (specifically, the opioid crisis), has needs that will not fit into the traditional, current medicaid program, especially in indiana. the following discussion contains policy recommendations based on the health needs of these individuals and what is most attainable and feasible in indiana. with the growing recognition that this opioid crisis is a public health issue rather than a criminal justice problem,108 the policy recommendations set forth will be analyzed using nancy kass’ six-step ethics framework for public health interventions109 to consider any ethical implications within each proposal. research demonstrates a need to nurture and provide for this resilient group of individuals, arising out of the current opioid crisis. a. policy previously mentioned, the family supports waiver is the basic entry point to receive services for children with a developmental disability.110 currently, this waiver has a cap on services at $17,300 per year.111 a first policy recommendation is for the indiana general assembly to create a regulatory ability for this allowance to go toward services reimbursed under any waiver, regardless of the issue of primary and secondary diagnoses. this would solve the issue of an individual on the fs waiver not being able to access mental health and addiction treatment services. because the total cap on services would remain the same, indiana would not need to spend any additional dollars on these individuals. a second policy recommendation would be to create a new medicaid waiver 108. see u.s. dep’t of health & human serv., facing addiction in america: the surgeon general’s report on alcohol, drugs, and health 1-2 (2016), h t tps://addiction.surgeongeneral.gov/sites/default/files/surgeon-generals-report .pdf [https://perma.cc/ex3u-2vzr]. press release, american academy of family physicians, american academy of pediatrics, the american college of obstetricians and gynecologists, american college of physicians, american osteopathic association, american psychiatric association, joint principles on opioid crisis call for comprehensive, public health approach to addiction treatment (june 11, 2018), https://www.aafp.org/media-center/releasesstatements/all/2018/joint-principles-on-opioid-crisis.html [https://perma.cc/2x37-uubk]. see generally andrew kolodny et al., the prescription opioid and heroin crisis: a public health approach to an epidemic of addiction, 36 annual rev. of pub. health, 559 (2015). see america’s drug overdose epidemic: data to action, ctrs. for disease control & prevention, https://www.cdc.gov/features/confronting-opioids/index.html [https://perma.cc/bb7y-wlsv]. 109. see generally nancy e. kass, an ethics framework for public health, 91 am. j. pub. health 1776 (2001). 110. wheeler, supra note 93. 111. family & soc. serv. admin., supra note 86. 2020] indiana medicaid: hope amid a crisis 197 or program entirely, specially tailored to this cohort of individuals born with nas. under section 1915(c) of the social security act, a state can create a waiver for home and community based services (similar to those already created by indiana) to allow beneficiaries with long-term services and support to receive medicaid-reimbursed care outside of an institutional setting.112 the idea is to tailor a waiver specifically to the needs of these individuals and demonstrate, based on current research, that these individuals have an increased risk to develop long-term health issues including cognitive, mental health, and substance abuse problems.113 similarly, states can also create a program that offers acute-care services and long-term services by defining and establishing a separate eligibility group.114 indiana has already done both, as mentioned, with the fs waiver, the aged & disabled waiver, the community integration and habilitation waiver, including some other 1915(i) programs tailored to mental health and substance abuse treatment.115 but again, there is currently no regulatory ability for an individual to utilize services from more than one program. this restricts an individual with the ability to treat only one or two of their health conditions, leaving a potentially life-threatening issue, such as a substance use disorder or mental health issue, untreated. ethically, individuals should not have to pick what medical problems get treated and which ones go untreated, especially when those issues are life threatening or altering and may contribute to the growing substance abuse crisis. ideally, a new medicaid wavier or program would be created for and tailored to this cohort to allow access to mental health and addiction treatment services, in conjunction with other developmental disability services they may require throughout childhood, to adolescence, and throughout their life. a third recommendation would be to restructure regulations and policies regarding primary and secondary diagnosis eligibility requirements for the medicaid waivers. stated earlier, an individual’s primary diagnosis determines which medicaid waiver program for which they are eligible or ineligible.116 essentially, the first major diagnosis an individual is given becomes their primary diagnosis for life and is rarely, if ever, changed.117 again, a child prenatally 112. huberfeld, weeks, & outterson, supra note 58, at 92. see also national overview of 1915(c) hcbs waivers, ctrs. for medicare & medicaid serv., https://www.cms.gov/ outreach-and-education/american-indian-alaska-native/aian/ltss-ta-center/info/nationaloverview-1915-c-waivers.html [https://perma.cc/hae6-v5ce]. 113. see generally nagle & watson, supra note 41, at 444-53; merikangas et al., supra note 41. see also merhar et al., supra note 36. see also hall et al., supra note 37. 114. home & community-based services 1915(i), medicaid.gov, https://www.medicaid.gov/ medicaid/hcbs/authorities/1915-i/index.html [https://perma.cc/7nu2-z78h]. 115. family & soc. serv. admin., supra, note 72. 116. see, e.g., 405 i. a. c. § 5-21.6-4. see also i. a. c § 5-21.8-4 (2018). see also 405 i. a. c. § 5-21.7-5. 117. see meseguer, supra note 88. 198 indiana health law review [vol. 17:183 exposed to opioids is given a primary diagnosis of developmental disability118 and this primary diagnosis generally does not change.119 if this same individual is later diagnosed with some other diagnoses, such as a mental health or substance use disorder, this becomes the secondary, tertiary (and so on) diagnosis; the primary diagnosis stays the same regardless of whether the secondary or tertiary diagnosis affects their daily lives more.120 the intention with this recommendation of restructuring the policies surrounding primary, secondary, and so on, diagnoses is to allow for more flexibility in changing an individual’s primary diagnosis. ideally, a provider would have more discretion to switch the primary diagnosis to what is affecting the individual most significantly. accordingly, an individual born with nas given a primary diagnosis of a developmental disorder, hypothetically utilizing indiana medicaid in addition to the fs waiver for their medical needs, may be for eligible for one of the mental health or addiction treatment waivers by their provider changing their primary diagnosis to one of the qualifying disorders, if such disorder arises in the future. put another way, if a mental health or addiction problem is affecting an individual’s life more significantly than their developmental disability, this allows for a provider involved in the patient’s care to change the primary diagnosis to the mental health or addiction problem thereby allowing the individual to access services under one of the dmha waivers. a fourth recommendation relates to the current mental healthcare provider shortage. broadly speaking, better access to behavioral health, mental health, and addiction treatment are needed, whether that is through more providers specializing in that field or training more primary care providers to have the ability to integrate that type of treatment in the primary care setting. the previous surgeon general, dr. vivek murthy, in his report identified both these concerns by stressing the need to integrate these types of treatment into the primary healthcare setting, a need to restructure how this type of treatment is billed allowing for reimbursement in the primary care setting,121 and creating a widespread workforce prepared to handle mental health, behavioral health, and substance use disorder.122 while mild substance use disorders may be treated in the primary care setting, more serious conditions likely require specialty residential or intensive outpatient treatment with some sort of long-term management.123 this returns to the issue of the shortage of workforce trained to handle mental health, behavioral health, and substance use disorders.124 a fifth recommendation 118. see supra text accompanying note 88. 119. see meseguer, supra note 88, at 50. 120. id. (in the context of the social security administration). 121. see u.s. dep’t of health & human serv., supra note 108, at 1-20. 122. see id. at 7-10 – 7-11 (recommending professional schools and continuing education programs incorporate curricula surrounding the most up to date information regarding substance use disorder and science regarding prevention, treatment, and recovery). 123. id. at 6-3. 124. see id. at 6-31; see also vestal, supra note 52. 2020] indiana medicaid: hope amid a crisis 199 is for indiana to find innovative ways to increase this workforce through financial incentives and education. the university of wisconsin and the medical college of wisconsin added psychiatric training positions to their post medical school options, and just by this addition, the number of psychiatry residents throughout the nation grew by 5.3%.125 the surgeon general’s report goes even further by suggesting that states implement financial incentives for medical students and other professional students to go into this area by utilizing the health resources & services administration (hrsa) awards to provide grants, scholarships, and loan repayments programs.126 creating a more expansive workforce is important for indiana’s substance and opioid use crisis, especially when it comes to rural communities, and the best way to do this is for indiana to use grants or other financial resources available to create opportunities for professionals and professional students to seek training opportunities in these underserved specialties, behavioral, mental, and addiction health. b. ethical and public health considerations several of the policy recommendations discussed above would include either new or a reallocation of resources directed toward improving health outcomes of individuals born with nas. dr. nancy kass, an expert in public health ethics,127 set forth a six-step framework (hereinafter referred to as the “kass six-step framework”) designed to help public health professionals and leaders consider ethical implications of proposed policy interventions128 as i have done above. moral dilemmas can arise out of resource allocation; therefore, it is important to consider the populations affected before implementing the policies. while “no principle ought to have moral superiority over any other,” public health leaders have “affirmative obligations to improve the public’s health and, arguably, to reduce certain social inequities.”129 the first step of the kass six-step framework asks what are the public health goals of the proposed program?130 the goal of the intervention should be started in terms of, or as a piece of, a larger aim toward, reduction of morbidity and mortality.131 because existing data demonstrates a variety of health needs throughout the life course that have a likelihood of contributing to the cycle of substance misuse,132 policy interventions were chosen to focus on the whole 125. see levine, supra note 55. 126. see u.s. dep’t of health & human serv., supra note 108, at 6-33, 7-4; see also fy18 hrsa opioids fundings, health resources & servs. admin., https://www.hrsa.gov/opioids/ hrsa-fy18-awards.html [https://perma.cc/5jel-u58h]. 127. see nancy e. kass, scd, johns hopkins berman inst. bioethics, https://bioethics.jhu. edu/people/profile/nancy-kass/ [https://perma.cc/afz8-wfb5]. 128. see generally kass, supra note 109. 129. id. at 1777. 130. id. 131. id. at 1778. 132. see generally nagle & watson, supra note 41, at 444-453; merikangas et al., supra note 200 indiana health law review [vol. 17:183 person, and policies designed to reduce morbidity (future adverse health outcomes) among individuals born with nas rather than mortality with the hope of implementing policies that will strengthen primary, secondary, and tertiary prevention133 in substance use disorders. kass describes the importance of keeping the goal of public health interventions in terms of reducing morbidity or mortality because improving health should be at the forefront of public health interventions, and other goals such as increasing employment, increasing workplace productivity, and strengthening communities will follow as incidental or intermediary outcomes.134 the second step of the kass six-step framework asks how effective is the program in achieving its stated goal?135 only proven initiatives are ethically justified.136 to justify the chosen intervention(s), policymakers must consider the data available to support the assumption the policy will, in fact, achieve its goal in reducing morbidity or mortality.137 the recommended policies were chosen based on little to no requirements for indiana to increase spending. however, some of the proposals outlined above might cause a reallocation of sources, such as investing in incentives for healthcare professionals to enter the mental health or substance use disorder treatment workforce or reducing the cap of services on one waiver in order to create a new waiver or program specifically tailored to the needs of nas. if indiana does not want to increase spending on medicaid, this would call for a reduction in spending in one of the current programs in order to meet the goals of one of the outlined proposals. kass emphasizes, “in terms of cost, constraints on liberty, or targeting particular already vulnerable segments of the population—the stronger the evidence must be to demonstrate that the program will achieve its goals.”138 establishing this cohort of individuals born with nas are a vulnerable population and that they are at risk for several adverse long-term health outcomes, it is still important to remember the moral dilemma of no one population having no moral superiority over another.139 nevertheless, public health leaders have an affirmative duty to improve vulnerable populations’ health and reduce existing inequalities,140 and there is a strong, positive correlation between access to healthcare and improved health outcomes.141 41; see also merhar et al., supra note 36; see also hall et al., supra note 37. 133. see ctr. for disease control & prevention, prevention 1, https://www.cdc. gov/pictureofamerica/pdfs/picture_of_america_prevention.pdf [https://perma.cc /3er2-zm87] (describing primary, secondary, and tertiary prevention). 134. kass, supra note 109, at 1778. 135. id. 136. id. 137. id. 138. id. at 1779. 139. id. at 1777. 140. id. 141. see kevin fiscella et al., inequality in quality: addressing socioeconomic, racial, and ethnic disparities in health care, 283 j. am. med. ass’n 2579, 2579 (may 17, 2000). 2020] indiana medicaid: hope amid a crisis 201 kass states even with good data, a policy or program is not alone justified.142 the third step of the kass six-step framework asks what are the known or potential burdens of the program?143 there are three broad categories to consider: (1) risks to privacy and confidentiality; (2) risks to liberty, dignity, opportunity and/or self-determination, specifically, in terms of too much of a paternalistic ideology; and (3) risk to justice if an intervention is targeted at a certain group.144 as hinted at earlier, one of the potential burdens would be a reduction in medicaid spending on one group in order to fund a new program or waiver for this cohort of individuals born with nas. additionally, privacy and confidentiality could become a concern with opening up more access to types of healthcare treatment due to the fact individuals would have more providers involved in their care, unless efforts are made to incorporate screening and treatment for mild forms of substance use disorder into the primary care setting. conversely, burdens concerning paternalism are likely minimal in the policy recommendations, as individuals would not be mandated into mental health or addiction treatment in addition to any other type of behavioral treatment. the next step is to consider whether burdens can be minimized, and whether there are alternative approaches.145 the first policy recommendation (to allow individuals to access treatment on any waiver in which they retain an eligible diagnosis for) is the least burdensome on the individuals and on the government spending, as the cap would remain the same and other individuals on different waivers would not have any funding taken away from their program, like the proposal for the entirely new waiver or program would require. however, another state has created a similar program as the waiver program proposed for individuals born with nas. wisconsin received a grant to integrate services for “medically complex children enrolled” such as those needing behavioral or other mental health treatment in their state medicaid program.146 an early evaluation of this program showed promise, by healthcare costs decreasing and the children were more likely to attend primary care, schedules, therapies, and mental healthcare through this focused and integrated program.147 the fifth inquiry in the kass six-step framework asks is the program implemented fairly?148 fairness in this context does not mean that programs or resources must be allocated equally to all communities, but rather, the allocation should be equitable based on distributive justice.149 kass emphasizes distributions of programs, in this case, resources must be justified by data and social 142. kass, supra note 109, at 1779. 143. id. 144. id. 145. id. at 1780. 146. hannah katch, states are using flexibility to create successful, innovative medicaid programs 1, 2, 6 (2016), https://www.cbpp.org/research/health/states-are-usingflexibility-to-create-successful-innovative-medicaid-programs [https://perma.cc/5han-9ysu]. 147. id. at 6. 148. kass, supra note 109, at 1780. 149. id. at 1780-81. 202 indiana health law review [vol. 17:183 consequences must be considered by any unequally allocated resources.150 in this circumstance, where indiana is preparing to take care of a cohort of individuals born of nas, policymakers must be aware all opioid-exposed infants are at increased risk for long-term medical problems151 and socioeconomic status is a “powerful predictor of health.”152 because these individuals born with nas are most likely to rely on medicaid,153 an indicator of lower socioeconomic status, even without exposure to opioids during birth, they are already at risk for premature death and other health disparities.154 adding in the data demonstrating additional health risks this population faces, they are arguably currently one of the most vulnerable populations in indiana and therefore equity justifies the unequal allocation of resources to them. as already discussed, justification exists as to why targeting this population through public health prevention measures can help end the substance abuse cycle,155 and that access to treatment improves health outcomes.156 the last step of the six-step kass framework asks how can the benefits and burdens of the program be fairly balanced?157 this is meant to be a procedural inquiry and includes a democratic process where society can engage in open discussion, voicing views from all socioeconomic classes.158 while it is meant to demonstrate the benefits society gains through a public health approach, stakeholders must understand others included in the discussion might have different priorities.159 the most obvious and significant burden of the proposed policy interventions are cost and where to pull funds from. however, investments in public health show a strong correlation with a healthy economy160 and support investments to support this population born with nas. the opioid crisis in indiana has been costly on the state’s economy. the opioid crisis has cost indiana approximately $43.3 billion in loss based on gross state product, resources spent individuals with substance use disorder, and resources spent on opioid-related deaths.161 this figure is consistent with the 150. id. at 1781. 151. hall et al., supra note 37, at 1. 152. kass, supra note 109, at 1781. 153. s.w. patrick et al., supra note 30, at 656. see hussaini & saavedra, supra note 17, at 1352. 154. see nancy e. adler & katherine newman, socioeconomic disparities in health: pathways and policies, health affs., 60 (2002). 155. see nagle & watson, supra note 41, at 444-53; merikangas et al., supra note 41; see also merhar et al., supra note 36; see also hall et al., supra note 37. 156. fiscella et al., supra note 141, at 2597. 157. kass, supra note 109, at 1781. 158. id. 159. id. 160. see michael blanding, public health and the u.s. economy, harv. t.h. chan sch. pub. health (2012), https://www.hsph.harvard.edu/news/magazine/public-health-economy-election/ [https://perma.cc/2bjg-7cyt]. 161. ryan m. brewer & kayla m. freeman, cumulative economic damages from 15 years 2020] indiana medicaid: hope amid a crisis 203 theory of a strong public health framework to create a healthy, productive workforce that generates a healthy state economy.162 taking into consideration the stakeholders “at the table” in this discussion, this type of benefit may be important in considering whether or not to implement one of the recommended policies. in sum, after utilizing the kass six-step framework, the policy recommendations laid out above are ethical public health interventions. the policy interventions are likely to achieve the goal of improving healthcare access to a vulnerable population with the goal of reducing morbidity. the potential burdens are recognized and minimized, and the expected benefits justify the potential burdens. based on this kass six-step framework, the policy interventions would be ethical. iv. conclusion appropriately identified as a “wicked” problem,163 this current opioid crisis has unfortunately exposed the fatal flaws of the fragmented, piecemeal u.s. healthcare system. additionally, our system has an unfortunate history of being reactive instead of proactive164 and public health has consistently been disregarded despite the recognition of its importance.165 one example, especially relevant in indiana, are the naloxone laws. prior to recognition, there was a crisis, naloxone, which is a lifesaving opioid overdose reversing drug, remained available only by prescription through a pharmacy and was not changed until 2016.166 an unfortunate reality of this change meant that thousands of hoosiers of opioid misuse throughout indiana, ind. bus. rev., https://www.ibrc.indiana.edu/ibr/ 2018/spring/article1.html [https://perma.cc/7tln-lmtn]. 162. see blanding, supra note 160. 163. see lee, supra note 9 (describing the opioid overdose epidemic as an “endemic complex system[] with components that interact in complicated, poorly understood and unpredictable ways” and as “impossible to establish a single locus . . .”). 164. see susan milligan, why is health care so complicated?, u.s. news & world rep. (june 30, 2018), https://www.usnews.com/news/the-report/articles/2017-06-30/why-cant-congressfigure-out-health-care-reform/ [https://perma.cc/vbs3-ps73] (quoting john mcdonough from harvard’s t.h. chan school of public health, “[i]t’s a basic principle of behavioral economics that people are much more risk-averse than they are risk-takers.”). 165. see generally office of inspector gen., public health and managed care: opportunities for collaboration (1999), https://oig.hhs.gov/oei/reports/oei-01-98-00170.pdf [https://perma.cc/6fmm-rzgv]. see jeffrey levi, ensuring timely access to care for people with hiv infection: a public health imperative, 92 am. j. pub. health 339, 339-340 (2002) (describing the lessons the hiv epidemic taught us including necessary early public health interventions and consistent healthcare delivery for all regardless of socioeconomic status). 166. see shari rudavsky, the surgeon general wants more of us to carry naloxone. here’s where to get it free, indy star (may 5, 2018), https://www.indystar.com/story/news/2018/05/ 05/indiana-health-officials-give-free-naloxone-prevent-overdose-deaths/582337002/ [https://perma.cc/sw6e-yut2]. 204 indiana health law review [vol. 17:183 had to die before this new law was passed. the federal government has shown signs it believes the opioid crisis is over. while the federal government provided a large lump sum of money to address the opioid crisis initially through the support act,167 and called for an additional $7 billion in the budget for 2019, the trump administration dropped its request to only $3 billion.168 additionally, several experts argue that this crisis is not simply one that has come and gone, but rather exposes the inadequate infrastructure for those suffering from addictions in the united states which is not something that can be solved with one lump sum of money and no additional, long-term policy change from the federal government.169 this is significant, as the addictions crisis seems to be morphing from opioids to other illicit drugs such as cocaine and meth.170 the previous discussion suggests that states can no longer rely on the federal government to step in and provide any additional funding or legislative change. the previous discussion also suggests that the united states is no longer in solely an opioid crisis, rather an addiction crisis generally. the infrastructure of addiction treatment needs to be improved by states, like indiana, and part of that infrastructure should be, and can be, more accessible healthcare especially to those that are at high risk for perpetuating addiction crisis. social determinants of health continue to be a driver in health inequities. socioeconomic status most often determines what type of healthcare an individual will receive, for example, private or employer-based insurance, or government-funded insurance like medicaid. while socioeconomic status is considered to be a social determinant of health, another determinant of health is called a structural determinant of health, and those “include architectural, economic, or political frameworks that create barriers to remediating social 167. musumeci & tolbert, supra note 3; german lopez, trump just signed a bipartisan bill to confront the opioid epidemic, vox (oct. 24, 2018), https://www.vox.com/policy-andpolitics/2018/9/28/17913938/trump-opioid-epidemic-congress-support-act-bill-law https://www.vox.com/policy-and-politics/2018/9/28/17913938/trump-opioid-epidemic-congresssupport-act-bill-law [https://perma.cc/25q8-nsxt]. 168. lopez, supra note 167; german lopez, trump’s budget proposal does nothing for the opioid epidemic, vox (mar. 11, 2019), https://www.vox.com/policy-and-politics/2019/3/11/ 18260152/trump-budget-opioid-epidemic-2019 (the author noting trump’s budget proposal called for $8.6 billion to build parts of the united states-mexico border, which he argued would prevent illicit drugs entering the united states). 169. id. (highlighting the inconsistencies across addiction treatment facilities and how only few offer the “gold standard” of care). 170. martha bebinger, fentanyl-linked deaths: the u.s. opioid epidemic’s third wave begins, npr (mar. 21, 2019), https://www.npr.org/sections/health-shots/2019/03/21/704557684/ fentanyl-linked-deaths-the-u-s-opioid-epidemics-third-wave-begins [https://perma.cc/2uf5-d6pj]; dan vergano, the opioid crisis is becoming a meth and cocaine crisis, buzzfeed news (jan. 16, 2019), https://www.buzzfeednews.com/article/danvergano/cocaine-meth-overdose-wave [https://perma.cc/7l4n-lguv]. 2020] indiana medicaid: hope amid a crisis 205 determinants or perpetuate social determinants such as health inequities.”171 arguing the u.s. healthcare system itself is a structural determinant of health172 is not so egregious as indiana’s medicaid system is being exposed by the inherent inequality resulting from the vulnerable population of individuals born with nas unable to receive the full spectrum of care they require. without some sort of policy action, the current healthcare system, both nationally and in indiana, will continue to perpetuate the opioid crisis. indiana has the opportunity to be a leader and create a healthcare delivery system that meets the needs of the population of individuals born amid the opioid crisis and be better prepared for future crises. this discussion has shown that under current policies, individuals born with nas are unlikely to receive the full spectrum of care they may require across their lifespan.173 further, neglecting to provide the treatment these individuals need may only perpetuate addiction in the united states. this discussion has offered attainable solutions at the policy level that reflect larger themes of inadequacy in the united states healthcare system. these broader policy arguments are outside the scope of this note discussion. however, through this example of nas in the opioid crisis, the areas where the healthcare system is weak have been exposed. taking a “half glass full” perspective, this can provide an opportunity. again, indiana has the opportunity to be a national leader by creating a healthcare delivery system that meets the needs of a vulnerable population and reflecting a healthcare policy that considers the determinants of health. 171. nicolas p. terry, structural determinism amplifying the opioid crisis: it's the healthcare, stupid!, 11 ne. univ. l. rev. 315, 325 (2019). 172. id. at 318 (arguing the u.s. healthcare system itself is a structural determinant of health and should take some responsibility in driving the current opioid crisis). 173. see generally nagle & watson, supra note 41, at 444-53; merikangas et al., supra note 41; see also merhar et al., supra note 36; see also hall et al., supra note 37. confronting child trafficking* jonathan todres** virtual grand rounds summer series lecture*** july 16, 2020 good afternoon everyone, or good morning for those of you who are on the west coast. i want to thank the hall center for law and health, indiana university, nicolas terry, and brittany kelly for inviting me to be part of this series. i also want to thank each of you for joining today. i know that you are busy. and, these days, many of us are dealing with additional obligations, as we simultaneously attempt to balance work and childcare duties during a pandemic. i appreciate that you have taken the time today to show your interest in this issue and join us for this event. i want to talk about where we are today on human trafficking, and on child trafficking in particular. i will begin with an overview of the current response to human trafficking, which is largely grounded in a criminal justice framework.1 i then will discuss briefly a range of other possibilities or additional frameworks that could be drawn upon and have been used to a limited extent, including human rights frameworks. then, the bulk of my presentation will focus on the public health approach: what can public health methodologies add to our responses to human trafficking? toward the end of the presentation, i will talk about a “toolkit” that a colleague and i developed.2 this toolkit is a starting point, or set of questions, that we believe can help build a more robust response to human trafficking. finally, i will talk briefly at the end about the impact of * copyright © 2020, jonathan todres. all rights reserved. ** jonathan todres is a distinguished university professor and professor of law at georgia state university college of law. he is co-author of preventing child trafficking: a public health approach (johns hopkins university press, 2019). this essay is an edited version of a presentation given on july 16, 2020, as part of the virtual grand rounds summer series at the hall center for law and health at the indiana university robert h. mckinney school of law. my thanks to the hall center for the invitation to present and to the editors of the indiana health law review for their assistance with this essay. *** indiana health law review and the william s. and christine s. hall center for law and health at the indiana university robert h. mckinney school of law give special thanks to professor jonathan todres for participating in the virtual grand rounds summer series and providing his informative perspective on human trafficking. 1. jonathan todres, widening our lens: incorporating essential perspectives in the fight against human trafficking, 33 mich. j. int’l l. 53, 57-67 (2011). see also janie a. chuang, rescuing trafficking from ideological capture: prostitution reform and anti-trafficking law and policy, 158 u. pa. l. rev. 1655, 1725 (2010); jennifer m. chacon, tensions and tradeoffs: protecting trafficking victims in the era of immigration enforcement, u. pa. l. rev. 1609, 1617-20 (2010). 2. this public health toolkit was first developed and published in jonathan todres & angela diaz, preventing child trafficking: a public health approach 198-207 (2019). 96 indiana health law review [vol. 18:95 covid-19, which is having a significant impact on human trafficking and responses to human trafficking. so, with that plan, let’s get underway. human trafficking is regularly in the news.3 media stories on the topic are a weekly, if not daily, occurrence. in addition, agencies and organizations at all levels—from local, to national, to international—are actively pursuing antitrafficking agendas.4 that level of attention to human trafficking is a relatively recent phenomenon. when i started researching this issue as a law student in the late 1990s, more than 20 years ago, there was no federal law on human trafficking. the trafficking victims protection act, known as the tvpa, which is the cornerstone of federal anti-trafficking law, did not exist in the 1990s. it was adopted in 2000.5 the same is true at the international level; the trafficking protocol was not adopted until 2000.6 and closer to home, no state had an anti-trafficking law twenty years ago.7 in the last twenty years, we have seen dramatic changes from a legislative perspective. the trafficking victims protection act has been reauthorized five times since 2000, and it has spurred other federal law and policy aimed at 3. see, e.g., aisha salaudeen, new nollywood film shines a light on human trafficking in nigeria, cnn (oct. 7, 2020), https://www.cnn.com/2020/10/07/africa/human-trafficking-filmnigeria/index.html [https://perma.cc/l6n3-2rg9]; margie mason & robin mcdowell, palm oil labor abuses linked to world’s top brands, banks, n.y. times (sept. 24, 2020), https://www.washingtonpost.com/business/palm-oil-labor-abuses-linked-to-worlds-top-brandsbanks/2020/09/24/2bdbfbac-fed8-11ea-b0e4-350e4e60cc91_story.html [https://perma.cc/qt3ppzzn]; alexis stephens, marietta hotel the latest named in federal sex trafficking lawsuits, atlanta j.-const. (aug. 17, 2020), https://www.ajc.com/news/marietta-hotel-the-latest-namedin -f e d e r a l s e x t r a f f ick in g-lawsu it s /4 6 kkr ap sd zc z5 aa7 wlo j b o ld t m/ [https://perma.cc/ney8-pdnr]. 4. see, e.g., human trafficking, n.y. st., https://www.criminaljustice.ny.gov/pio/ humantrafficking/humantrafficking.htm [https://perma.cc/e9jm-um4r] (last visited dec. 21, 2020); office on trafficking in persons, admin. for child. & fam., https://www.acf.hhs.gov/ office-on-trafficking-in-persons [https://perma.cc/2y7q-w4p5] (last visited dec. 21, 2020); u.s. dep’t of state, trafficking in persons report 3 (2020), https://www.state.gov/wpcontent/uploads/2020/06/2020-tip-report-complete-062420-final.pdf [https://perma.cc/dfp3gylc]; human trafficking knowledge portal, u.n. off. on drugs & crime, https://sherloc. unodc.org/cld/en/v3/htms/index.html [https://perma.cc/tb8d-eetu] (last visited dec. 21, 2020). 5. victims of trafficking and violence protection act of 2000, pub. l. no. 106-386. 6. protocol to prevent, suppress and punish trafficking in persons, especially women and children, supplementing the united nations convention against transnational organized crime, art. 6(3), opened for signature dec. 12, 2000, s. treaty doc no. 108-16, 2237 u.n.t.s. 319 [hereinafter trafficking protocol]. a second important treaty in this context was also adopted in 2000. see optional protocol to the convention on the rights of the child on the sale of children, child prostitution and child pornography, g.a. res. 54/263, u.n. doc. a/res/54/263 (may 25, 2000). 7. human trafficking state laws, nat’l conf. st. leg., https://www.ncsl.org/research/ civil-and-criminal-justice/human-trafficking-laws.aspx [https://perma.cc/f6j7-vjzd] (last visited dec. 21, 2020). 2021] confronting child trafficking 97 addressing human trafficking.8 all major federal agencies now have a task force, group, or initiative that addresses human trafficking.9 all states now have antitrafficking laws, and many of the states have further revised their anti-trafficking laws in recent years.10 in addition, when i started in the 1990s, there was very little in the way of services for survivors of human trafficking, either children or adults. to the extent services were available, they typically were social services available to the general population; they were not tailored to the specific needs of survivors of human trafficking. in the past twenty years, the number of shelters for survivors has grown, as have the number of human trafficking related training programs for social service providers, health care professionals, and others who can play a role in addressing to human trafficking.11 these are notable improvements, though much more is still needed. finally, when i started on this topic in the 1990s and would tell people that i was working on trafficking, most people immediately assumed that i worked on drug trafficking issues. every now and then, someone would respond by telling me about their morning commute, somehow thinking that i could solve that problem. these responses reflected how little people knew about human trafficking and how it simply wasn’t in the public consciousness. as i noted earlier, human trafficking is now regularly in the news. and, there are probably hundreds, if not thousands, of organizations working on human trafficking today. all these developments—new legislation, progress on social services, and greater public awareness—are important and suggest progress. but, for me, when we pause to ask whether we are making progress, it should compel us to return to our goals. what is the goal? i submit that the goal must be to prevent human trafficking from occurring. by that measure, we haven’t made as 8. trafficking victims protection reauthorization act of 2003, pub. l. no. 108-193; trafficking victims protection reauthorization act of 2005, pub. l. no. 109-164; william wilberforce trafficking victims protection reauthorization act of 2008, pub. l. no. 110-457; violence against women reauthorization act of 2013, pub. l. no. 113-4; trafficking victims protection reauthorization act of 2017, pub. l. no. 115-427 (2019). 9. see, e.g., what is human trafficking, u.s. dep’t homeland security, https://www. dhs.gov/blue-campaign/what-human-trafficking [https://perma.cc/alt4-ggey] (last visited dec. 21, 2020); human trafficking, u.s. dep’t just., https://www.justice.gov/ humantrafficking [https://perma.cc/2ygc-t5rs] (last visited dec. 21, 2020); u.s. dep’t of state, supra note 4; office on trafficking in persons, supra note 4; usdot steps up fight against human trafficking, u.s. dep’t transp., https://www.transportation.gov/dot-effort-to-stop-human-trafficking [https:// perma.cc/9g7a-cp6a] (last visited dec. 21, 2020). 10. see a look back: building a human trafficking legal framework, polaris project, https://polarisproject.org/wp-content/uploads/2019/09/2014-look-back.pdf [https://perma.cc/8829hjzj] (last visited dec. 21, 2020); 2014 state ratings on human trafficking laws, polaris project, https://polarisproject.org/wp-content/uploads/2019/09/2014-state-ratings.pdf [https:// perma.cc/24pk-5a27] (last visited dec. 21, 2020). 11. see, e.g., heal trafficking, https://healtrafficking.org/ [https://perma.cc/cd9j-rev2] (last visited dec. 21, 2020). 98 indiana health law review [vol. 18:95 much progress as you might think, or hope. indeed, it is widely understood and agreed upon among those working in the field that human trafficking has not declined in the last twenty years.12 that is, despite all these efforts and the tireless work of many people in the field, we do not see a decline in prevalence. now, in fairness, that is a bit of an unfair statement because we do not have good baseline data or reliable estimates on the number of individuals trafficked every year.13 we know that human trafficking is a widespread problem both globally and in the united states, but we do not have exact numbers. that said, most experts in the field agree that there is no evidence of a decline. this should challenge us to rethink what we are doing. a lot of the great work being done in the field focuses on addressing harm after it occurs—that is, prosecuting perpetrators after harm has occurred, or assisting survivors after harm has occurred. these are essential components of a response. i am not minimizing their importance. but if our goal is to reduce and ultimately end human trafficking, this “after the harm has occurred” approach is not going to get us there. as i have written about in other settings,14 a criminal justice framework has been the cornerstone of our response to human trafficking to date. there are several rationales for a criminal justice response. first, criminal justice’s core functions are to apprehend perpetrators of criminal acts and deter future crimes, so it is not surprising that we would use a criminal justice framework to confront criminal activity such as the exploitation of human beings. second, there are practical reasons why we have relied on a criminal justice framework in our response to human trafficking. criminal justice institutions are well-positioned to respond. moreover, using the criminal justice system allows us to build on already-existing institutions and processes. third, there is an expressive component.15 through criminal law, we can say that, as a society, we deem certain behaviors unacceptable. we can say that we believe these acts are among the worst that one can perpetrate; in some respects, that’s some of what we’ve seen, as legislative amendments at the federal and state level have increased penalties for human trafficking over the years. although there are rationales for a criminal justice framed approach to human 12. see, e.g., u.n. off. on drugs & crime, global report on trafficking in persons 2018, 7 (2018), http://www.unodc.org/documents/data-and-analysis/glotip/2018/glotip_2018_ book_web_small.pdf [https://perma.cc/34es-2z4x] (finding no evidence of a decline in prevalence of human trafficking); maria tavano, trafficking in persons: a focus on preventing forced labor, 32 women’s rts. l. rep. 324, 351 (2011) (“[w]hile more and more countries have joined the war on human trafficking, there is no evidence of a decrease in the prevalence of the crime.”). 13. todres & diaz, supra note 2, at 19-21. 14. see, e.g., todres, supra note 1, at 55. 15. see generally carla spivack, the dilemma of the transgender heir, 33 quinn. prob. l.j. 147, 148 (2020); danielle keats citron, law’s expressive value in combating cyber gender harassment, 108 mich. l. rev. 373, 377 (2009); cass r. sunstein, on the expressive function of law, 144 u. pa l. rev. 2021 (1996). 2021] confronting child trafficking 99 trafficking, there are also some limitations. when i say “limitations,” i mean it as less of a critique of the criminal justice framework than i do as a critique of our over-reliance on a criminal justice framework. criminal justice frameworks do certain things well, and other things they are not designed to do. today, we rely on the criminal justice system to do much more than it is really designed or equipped to do. let me start with the scope of the harm. survivors of human trafficking have experienced physical, emotional, and often sexual violence. a criminal justice system is not designed to remedy that. the criminal justice system is not a health care intervention. it is not designed to address the harms individuals suffer as a result of human trafficking. therefore, we cannot rely solely on criminal justice for an effective response. in addition, the criminal justice system does not address the root causes of the problem. it does not address why some individuals are more vulnerable to exploitation than others, or what is driving the demand for goods and services produced by exploited individuals. further, even with respect to the core goals of criminal justice—deterrence and apprehending perpetrators—criminal justice acting alone has limitations. what we see is that only a relatively small number of traffickers are arrested and prosecuted in any given year.16 as there is no evidence of a decline in prevalence, then in terms of deterrence, it is not working as we would hope. this should not surprise us completely. if you think about the war on drugs and other issues where we rely heavily on a criminal justice response, we often do not see the results we would want.17 in other words, we cannot prosecute our way out of the problem of human trafficking. we must prosecute perpetrators, but we cannot rely on that as the exclusive means of solving the problem. last, relying on the criminal justice system has an anchoring effect. one of the things we have seen is that it gets very hard to move towards other frameworks when you have built a response around one framework. from the world of administrative law, and specifically, multiple goals theory, we learn that an entity, when faced with multiple goals, will return over time to its primary functions and whatever it is incentivized to do.18 here’s how that is relevant in responses to human trafficking. for a number of years, advocates have been urging law enforcement to be more victim centered. that’s an important step, because we should give greater priority to survivors’ needs and interests. and some law enforcement personnel and prosecutors do that very well. however, the incentive structure in law enforcement typically is not designed to prioritize sensitivity towards victims. ask yourself, who is more likely to get promoted—a police officer who has successfully arrested a high number of perpetrators, or the police officer who has arrested no one but is known for being particularly sensitive to crime victims? i think we know the answer. we must be attuned to 16. u.s. dep’t of state, supra note 4, at 20. 17. see generally human rights watch, every 25 seconds: the human toll of criminalizing drug use in the united states 1 (2016). 18. todres, supra note 1, at 64-65. 100 indiana health law review [vol. 18:95 this anchoring effect, and if we want to change behaviors of particular stakeholders, then we need to account for institutional incentives. in a nutshell, we need to broaden our approach and consider other perspectives or frameworks that can strengthen our response. there are four other frameworks listed on the slides here.19 although i have researched all these frameworks, i have worked most often with human rights and children’s rights perspectives. in addition, prior to entering the law, i worked in international development. and then, for the past decade, i have focused on what public health methods and perspectives can add to our efforts to address human trafficking. let me touch briefly on the other perspectives, before focusing on public health methods for the remainder of this presentation. human rights perspectives and human rights approaches offer the opportunity to reduce vulnerability. in marginalized communities, vulnerable individuals often have less access to health care. those individuals may be ill more often and have illnesses that last longer. how does that affect children? well, it may mean higher absenteeism rates in school. in turn, children who miss school more often tend to fall behind their peers. and when they fall behind their peers, they are at an increased chance of dropping out. if you drop out earlier, and you are a thirteen, fourteen, or fifteen-year-old kid with limited skills, you are a prime target for exploitation. so, human rights approaches—which include securing health care, education and housing rights among other issues—can help reduce vulnerability to exploitation. an international development perspective helps us understand the economic realities of many communities. one of the things we know about trafficking globally is that many individuals start out by migrating and then end up in trafficking situations. one of the reasons they migrate is because there are no opportunities where they live, and socioeconomic development is inadequate where they live. drawing upon development perspectives can help us better understand how to develop sustainable programs and policies that strengthen communities. international development also teaches us about partnering with local communities. labor perspectives are important as well. they help us understand human trafficking as part of a spectrum of labor. on the one end of the spectrum, there is safe and secure employment with a decent living wage. the other end of the spectrum is exploitation, including trafficking and other harms. if we see human trafficking on a spectrum, we can start to understand how sometimes people are pushed to the margins. their vulnerable circumstances may push them into risky employment settings, and after that, it does not take much before that risky employment setting turns into something much worse—exploitation through trafficking, for example. finally, there is a public health approach. this is where we will spend the rest of our time. on this slide, you see the cornerstones of a public health approach listed: an emphasis on evidence-based research, a focus on prevention, addressing 19. human rights perspective, international development perspective, labor perspective, and public health perspective. 2021] confronting child trafficking 101 the underlying causes, partnering with relevant stakeholders, and using the socioecological model.20 let’s start with the last one first, and then we will go in order after that. the socioecological model is used to address the interplay between individual, relationship, community, and societal factors.21 in the human trafficking context, this means identifying the risk factors at each level and how they interact with each other. for example, we know that a history of child maltreatment is an individual level risk factor for trafficking. we also know that certain unhealthy relationships increase risk, and that unsafe schools and neighborhoods add to risk. also, societal factors such as discrimination and marginalization of certain communities, tolerance of gender-based violence and discrimination, and the sexualization of young girls all contribute to the problem. so, by taking a socioecological approach to this issue, we can better understand all that is happening to make one individual or a group of individuals vulnerable. in our response to human trafficking, we must account for the risk factors at every level of the socioecological model. equally important, we need to identify protective factors that build or strengthen resilience. ultimately, it is critical that we design law, policy, and programmatic interventions that address all levels of the socioecological model. next, evidence-based research is essential to designing effective responses. we are starting to develop a robust body of research that gives us insight into risk factors. this is still emerging, but it has improved. we know less about protective factors. it is important to note that the absence of a risk factor is not necessarily a protective factor. for example, a history of child maltreatment is a risk factor, but the fact that you were not abused as a child does not mean that is a protective factor. in addition, we do not know a lot about the efficacy of assistance programs. there are more programs for survivors today, but we have limited evidence on which programs work best for which individuals. finally, we are well behind in our research on labor trafficking. evidence-based research is so critical today because many data points reported widely in the media are not necessarily rooted in evidence-based research and may be inaccurate. without evidence-based research, there is a risk that policies will be designed, and resources allocated, based on inaccurate pictures of the problem.22 next is prevention. prevention is what public health does—it aims to prevent harms to populations. in the context of a disease outbreak, it would not make sense from a public health perspective to allow an outbreak to occur and try to figure out who is responsible for it later. from a public health perspective, success is a fully immunized population so that there is no disease outbreak in the first place. that is how we must approach human trafficking. what will reduce 20. todres & diaz, supra note 2, at 91-96. 21. the social-ecological model: a framework for prevention, ctrs. for disease control & prevention, https://www.cdc.gov/violenceprevention/publichealthissue/socialecologicalmodel.html [https://perma.cc/bz6w-wkeg] (last visited oct. 24, 2020). 22. see jonathan todres, human trafficking and film: how popular portrayals influence law and public perception, 101 cornell l. rev. online 1 (2015). 102 indiana health law review [vol. 18:95 vulnerability and demand so that we do not have these cases of exploitation in the first place? next, in terms of addressing the underlying causes, public health has a lot of experience confronting harms and thinking about the attitudes and behaviors that drive those harmful outcomes. consider the issue of smoking. public health campaigns helped change attitudes toward smoking; as a society, we went from thinking of it as an activity that makes you cool to recognizing it as a harmful activity. obviously, smoking is different from human trafficking in many ways, but the point is that public health campaigns can teach us a lot about what works in terms of changing attitudes and behaviors relevant to human trafficking. for example, think about labor trafficking. we all want to pay as little as possible for the food we eat and the clothes we wear. but, if we do that, chances are somebody is getting exploited in the supply chain. so, the question is: how do you motivate people to act altruistically? there is good research on this. people will act altruistically. typically, this works better if there is some sort of threat or negative consequences associated with the bad behavior and if they know that choosing the right option will make a difference. so, back to labor trafficking, how do you know that choosing to purchase the more expensive shirt will ensure that no one is exploited in the supply chain? at this moment, you probably don’t. but can we develop a response that would make it possible for consumers to make more informed choices? and can we motivate businesses not only to ensure their supply chains are free of trafficked labor but also to pressure their suppliers to ensure the same? this is just one piece of the puzzle, but by viewing this issue through a public health lens, we can start to see how to unpack the issue of human trafficking and what types of interventions must be developed so that we can reduce vulnerability and reduce demand. last, partnering with all stakeholders is essential. i mentioned this in the context of international development. it is also a point of emphasis in the human rights world. in the context of human trafficking, this means two things. first, we need to continue to broaden partnerships to involve all sectors of society. this means going beyond law enforcement and social services to involve health care, transportation, education, media, the private sector, and a whole host of other entities. second, we must engage and work with local communities that are at risk of, or affected by, human trafficking. critically, this also means listening to survivors. for example, if you are working on child trafficking, you must partner with young people at every stage of the process. this does not mean merely checking in with them after you have designed an anti-trafficking response. who is at the table from the very beginning is crucial. otherwise, we are going to design interventions that will not work very well for the populations they are intended to serve. in terms of including and elevating survivors, we have seen some progress, but it is piecemeal. too often, antitrafficking efforts continue to perpetuate an essentialized view of survivors. i have seen legislative briefings where they open the briefing by saying, “today we will hear from three experts and one survivor.” now, why are they not describing those individuals as four experts? in those situations, they really brought the survivor to exploit their story and to create an 2021] confronting child trafficking 103 emotional impact. they are not really seeing how valuable that survivor can be to the design, implementation, and evaluation of laws, policies, and programs on human trafficking. we need to rethink how we work with survivors. our ultimate goal must be to design a response that is comprehensive and integrated. that means all sectors need to be involved. and, within each sector, it cannot just be the special task force on human trafficking. so, in law enforcement, there are lots of jurisdictions where law enforcement has a special task force on human trafficking. that is great, but it is often the beat cop in the neighborhood who encounters human trafficking first. so, they also need to be brought into the fold. the same with health care. it is frequently emergency departments and emergency rooms, but it is not only them. pediatricians and others need to be aware of child trafficking, human trafficking, and how to identify it. it needs to be everyone across all sectors. equally important, our multi-sector response must be integrated. in other words, the services offered to those at risk of or exploited by human trafficking need to be seamless. now, i say that knowing that is a really hard thing to do, but think about how hard it is for a survivor who has just experienced significant trauma to try to navigate different services simultaneously to address physical health issues, mental health concerns, housing insecurity, food insecurity, education, job training, and the legal consequences of trafficking. public health has experience working with survivors of various harms. we can draw on the lessons from past public health campaigns—both good and those that were not as successful—to build a more comprehensive, integrated, and inclusive response to human trafficking. let’s move now to discuss the “toolkit” that my colleague, dr. angela diaz, and i developed and published in a book last year.23 the toolkit is really a starting point. it is a set of questions that we can all use in our own work individually, with our organizations, or within a sector, to advance our efforts to prevent human trafficking. if you are examining or contemplating a new or existing law, policy, or program, the first question you must ask is: does it help prevent human trafficking? it may sound simple, but most of what we have done to date does not address prevention. we need to start answering this question honestly. and if the answer is no, that does not mean that you cannot do it. there are lots of services for survivors that do not prevent human trafficking that we should still provide, but we ought to realize whether our actions actually make a difference in terms of prevention. second, what levels of the socioecological model does this initiative address? if it addresses only the individual level, it may help some individuals but miss the most vulnerable. if your initiative addresses only the individual level, can you add a component that addresses the community-based factors? can you develop a more robust response? if you cannot, can you partner with an organization that is doing something to address the relationship or community level so that together you can build a more comprehensive response? 23. todres & diaz, supra note 2, at 198-207. 104 indiana health law review [vol. 18:95 third, what are the underlying attitudes and behaviors you need to address? we have talked about this already, but we must address the attitudes and behaviors that foster a culture of tolerance of exploitation. we must think about this both nationally and locally within our home communities. these can be tough conversations, but if we don’t address the root causes of human trafficking, we will never reach our goal. fourth, is this initiative informed by evidence-based research? again, this is still not happening in all development of law, policy, and programs on human trafficking. so, we really need to emphasize this. we need to figure out what the evidence shows and ensure that legislators at the state and federal levels and decisionmakers at the relevant agencies are relying on robust research when developing and implementing new policies. fifth, have you worked with survivors, youth, families, and other relevant communities in developing or evaluating this initiative? this is critical. again, i see too often that youth are not consulted. does it add challenges to developing policies to have consultations with young people? of course, it does. but, too often after a policy or program is launched, young people say, “we knew right away this would never work. they didn’t address x, y, or z.” so, it is vital that we talk to young people. what we learn from them will help to develop more effective policies and programs. and as noted previously, we must do a better job listening to survivors. sixth, does your initiative have a strategy for collaboration with stakeholders? who is involved? who else needs to be at the table? and how do you ensure that everyone who should be in the room is in the room? ensuring diverse representation is necessary but not sufficient. you also need to confront challenging issues that can affect how diverse stakeholders work together. cultural humility is important. at an agency level, this might mean addressing data sharing agreements, for example. also, how will you navigate different approaches to work? for example, public health relies on public trust and requires transparency, while law enforcement, at times, cannot be as transparent, such as when they are engaged in undercover operations. how do you navigate these different approaches and make sure that stakeholders collaborate effectively? finally, what are the potential unintended consequences of the initiative you are considering? we need to anticipate unintended consequences. i want to emphasize that it cannot be only about planning for what might go wrong. we ought to be thinking about what might happen if the plan works out as envisioned. what if everything goes right? i will give you an example. some jurisdictions have identified strip clubs and similar adult venues as a gateway to trafficking. one intervention in response has been to raise the minimum age for working in such venues from eighteen to twenty years old. now, i recall one instance where this measure was celebrated as “saving” 2,000 girls and young women by raising the minimum age from eighteen to twenty-one. upon closer look, however, anecdotal evidence suggests that many those girls and young women ended up in much worse situations in underground prostitution rings. why? because no one thought about and planned for what would happen once this change was made. if someone had considered unintended 2021] confronting child trafficking 105 consequences, they would have readily seen that raising the minimum age to get girls and young women out of strip clubs would leave many out of work. that doesn’t mean it was wrong to raise the minimum age. the mistake was not anticipating the results and addressing them by also including programs and funding for education, job training, housing assistance, and other needs to provide genuine support for those they aimed to help. in short, it is vital that we think about unintended consequences as part of our starting point for assessing what we do. again, this toolkit is a starting point for ensuring that the conversations that we are having get us closer to identifying how we develop a more comprehensive response. if you continually return to these seven questions and use them to guide the development of antitrafficking responses, i believe it will help improve outcomes. before i conclude, i want to take a couple of minutes to talk briefly about the impact of covid-19. we know that covid-19 is not just revealing inequities but also exacerbating them in profound ways. this is also true with respect to human trafficking.24 for example, two of the risk factors for the trafficking of children are time on the street, meaning homelessness, and a history of child maltreatment.25 one of the things we know about covid-19 is that it has caused significant job loss. this is putting people at risk of being evicted from their homes by failing to make rent or mortgage payments. we know some jurisdictions adopted a moratorium on evictions, but those do not cover everyone. and, in a number of those jurisdictions, those payments are due soon. this means a host of back payments will soon be confronting people who may still be unemployed. so, that runs the risk that more people will be pushed to the streets. if they are pushed to the streets, youth in particular will be at risk. we also have evidence that child maltreatment has increased since march 2020. now, what is interesting is that, in some places, reporting has gone down. the reason reporting has gone down, however, is because mandatory reporters, most notably teachers and pediatricians, are not seeing kids nearly as much. in many of those same jurisdictions, although reporting has gone down, hospitals are reporting that the number of kids coming to emergency departments with child abuse-related injuries has increased. so, child maltreatment is likely increasing. and, again, child maltreatment is a risk factor for human trafficking among children, as well as a harm itself. thus, we must recognize that covid-19 is actually creating circumstances that are increasing the likelihood of risk factors occurring in populations. 24. jonathan todres & angela diaz, covid-19 and human trafficking—the amplified impact on vulnerable populations, jama pediatrics (sept. 21, 2020), https://jamanetwork.com/ journals/jamapediatrics/fullarticle/2770536 [https://perma.cc/n435-tsbp] [hereinafter covid-19 and human trafficking]. 25. inst. of med. & nat’l research council, confronting commercial sexual exploitation and sex trafficking of minors in the united states (ellen wright clayton et al. eds., 2013). 106 indiana health law review [vol. 18:95 in addition, when teachers and other mandatory reporters do not see children as often, it means fewer opportunities to identify individuals who are at risk of harm or are being harmed. in other words, covid-19 has not only increased risk, it has created barriers to identifying those needing assistance and to providing comprehensive services to survivors.26 we need to make sure that we recognize the impact of covid-19 in the area of human trafficking and that we start to account for that. let me close with the following thoughts. public health offers us the tools to strengthen our response to human trafficking. equally, if not more, important, public health strategies give us a better chance of preventing harm. if we can incorporate these public health tools, perspectives, and methodologies into our work on human trafficking, we can start to make more significant progress toward achieving a comprehensive, integrated response that prevents harm from occurring in the first place. thank you. 26. covid-19 and human trafficking, supra note 24. “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy keegan warren-clem* i. introduction ............................................................... 120 ii. gender-based disparities in access to health care .................................................................... 123 a. socio-economic access to care: the role of social determinants of health ......................................................... 124 1. economic stability ......................................................... 125 2. education ......................................................................... 127 3. social and community context .................................. 128 4. neighborhood and built environment ..................... 131 b. financial access to care: the role of insurance ..... 131 1. the prevalence of employer-based group insurance .............................................................................. 132 2. the contemporary non-group insurance market 136 3. medicaid [in]efficacy in facilitating access to care in the ppaca era ..................................................... 149 4. other third-party payors............................................ 156 c. reproductive access to care: the role of competing doctrines .............................................................. 158 d. transgendering access to care: the role of the non-binary gender perspective .......................................... 164 iii. remediating disparities in access to care through health as a (nonexistent) right ................... 167 a. the international formulation of a right to health and access to care .................................................... 168 b. a right to health or health care does not exist in the united states ............................................................... 171 c. legislated limited rights of access to specific care in the united states ..................................................... 173 http://dx.doi.org/10.18060/3911.0014 120 indiana health law review vol. 13:1 d. the melting pot federal policy on gender-based health disparities .................................................................. 178 iv. shifting public policy in the era of ppaca era and health-in-all-policies .................................... 181 a. the judiciary and legislative support for prioritizing health as a public policy ................................ 181 b. access to care redux ....................................................... 185 v. conclusion ................................................................. 192 abstract disparities in access to health care are frequently noted along racial lines, but missing from the literature is a robust discussion of the on-the-ground effects of law and policy in creating gender-based disparities outside of the abortion context. this paper seeks to fill that gap by focusing on persons similarly situated but for whom gender results in disparate access. accepting that neither a robust right to health nor to health care exists in the united states, the paper explores how recent legislative innovations, particularly the patient protection and affordable care act, coupled with executive initiatives and trends in the discipline of population health, suggest that a shift in public policy is occurring that could mitigate disparities for all persons if courts and state governments will follow the other federal branches’ lead. i. introduction “can this same procedure then be done in a pregnancy, swallowing a camera and helping the doctor determine what the situation is?”1 this question was recently posed by a * keegan warren-clem, jd, llm, was the inaugural southern illinois healthcare/southern illinois university medical-legal partnership master of laws fellow. a former equal justice works fellow, she is the founding legal champion of austin medical-legal partnership and an adjunct professor at the university of texas school of law. keegan is admitted to practice in texas and is a member of the 2016 121 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy male state representative in idaho in response to a physician’s testimony on medical procedures she considered more dangerous than an elective abortion induced by medication. on that list was colonoscopy via camera pill, which was the procedure that prompted the republican legislator’s question. the ensuing explanation, which differentiated the digestive tract from the reproductive system, was given over the crowd’s guffaws.2 the lawmaker later claimed the question had been “rhetorical.”3 whether the gentleman indeed failed to demonstrate an elementary understanding of female anatomy or whether he was merely “trying to make the point that equalizing . . . procedure[s] . . . was apples and oranges,”4 he was successful at identifying at least one issue: the healthcare access needs of women of childbearing age do not necessarily come in parity with those of other sub-populations. on the one hand, that disparate sex-based legal treatment of health issues arises as a function of the most obvious biophysical differences in men and women is of no surprise. after all, these are distinctions that invoke the most intimate of considerations. to the extent that the medical treatment in question derives from genuine sexbased biophysical variations, so, too, should the legal response vary. as a result, it would seem logical that jurisprudence on access to health care would reflect genderbased distinctions in need for care. the testimony described above could be an apt example of state intervention in the state bar college, an honorary society of the most highly trained lawyers in texas. she earned her j.d. from the university of texas and her b.a. from the university of arkansas. keegan thanks jennifer brobst for guidance and patience as this article was being researched and written. 1 chemical abortions: hearing on h.b. 154 before the h. state affairs comm., idaho leg. (feb. 23, 2015), http://lso.legislature.idaho.gov/mediaarchive/showcommitteeormedia. do (statement of rep. vito barbieri, member, h. state affairs comm.) (63rd leg., reg. sess.). 2 id. 3 kimberlee kruesi, lawmaker asks if swallowed camera be [sic] used for female exam, washington times (feb. 23, 2015, 9:16 pm), http://www.washingtontimes.com/news/2015/feb/23/lawmaker-asks-ifswallowed-camera-be-used-for-fema/?page=all [http://perma.cc/4vaa5aka]. 4 id. (quoting idaho rep. vito barbieri). http://www.washingtontimes.com/news/2015/feb/23/lawmaker-asks-if-swallowed-camera-be-used-for-fema/?page=all http://www.washingtontimes.com/news/2015/feb/23/lawmaker-asks-if-swallowed-camera-be-used-for-fema/?page=all 122 indiana health law review vol. 13:1 process of access to health care by certain women—i.e., would-be mothers seeking an abortifacient pill—in the name of protecting those women. on the other hand, the aforementioned legislature was considering restrictions on the use of telemedicine related only to accessing an otherwise lawful medical procedure.5 that is, men who sought treatment or diagnosis via the medium of telemedicine would not be similarly restricted. (neither, of course, would women seeking other types of treatment.) indeed, the testifying physician was arguing that the remote performance of riskier medical procedures would not be proscribed, suggesting that this legislation was targeted at restricting the ability of women to access one particular type of medical care where a provision that expressly sought to interfere with access to that care would not be constitutionally permissible. nor was it even actually a mere attempt to institute broad protections of health: one of the bill’s proponents bluntly stated that the intended effect was a circumscription on the target patient’s healthcare options.6 this paper theorizes that insofar as law and policy, through such determinations as above, has traditionally created a de facto gendered system of haves and have-nots in terms of access to care, contemporary efforts to remedy disparities in access exist sufficiently to create a public policy that prioritizes access to care and health in general. the paper begins by briefly laying out broad factors that tend to influence access to care and health, noting in particular how the socio-economic environment creates foundational genderbased disparities in access to care. it then provides a broad overview of the current status of access to care from several perspectives, with a focus on new data pertinent to systemic changes to the healthcare financial structure by the patient protection and affordable care act. the paper specifically makes note where these disparities are biophysically based 5 physician physical presence and women protection act, h.b. 154, 63rd leg., reg. sess. (idaho 2015) (enacted), http:// www.legislature.idaho.gov/legislation/2015/h0154.pdf [http://perma.cc/ x4xc-7r53]. 6 kruesi, supra note 3 (quoting republican representative linden bateman’s statement that “[i]n my view, this may reduce the number of abortions.”). 2016 123 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy on different sex-based medical needs, or whether they are the result of social constructs that may better lend themselves to legal remedy. the paper selectively employs both case law and legislative trends to explore the arc of justifications for, and interests that tend to interfere with, health care access according to the patient’s gender. insofar that remediable disparities in access exist, the paper explores in the next section the limited rights to access to health care, along with other efforts to remedy genderbased disparities in access to care. finally, the paper concludes by assuming that although health care perhaps cannot be understood as right-like, health is broadly regulated in ways that tend to support individual access. this is a theme that should be incorporated into judicial decisions on issues affecting health, which would tend to rectify disparate results in access to care. here the paper imports lessons from other pertinent legal perspectives, such as public health law, in the creation of outcomes that are doctrinally consistent, equally protective, and in furtherance of systemic health goals for humans of all genders. ii. gender-based disparities in access to health care what is it to have access to health care? insofar as it may be conceptualized as the ability to receive care in support of one’s health, the 1948 constitution of the world health organization (who) is instructive: there health is defined as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”7 it is a definition that has remained unchanged for nearly seventy years,8 suggesting that access to care for health has long been understood as encompassing access to both holistic 7 world health organization constitution [who], constitution of the world health organization, (signed on jul. 22, 1946), available at http://www.who.int/governance/eb/who_constitution_en.pdf [http:// perma.cc/sud2-u7gf]. 8 who, who definition of health, http://www.who.int/about/ definition/en/print.html [http://perma.cc/jlz7-gzl3] (last visited nov. 1, 2015). see also who: from small beginnings, 9 world health f. 29 (1988) (discussing background on the wording of the definition). 124 indiana health law review vol. 13:1 preventative services and medical treatment targeted at specific conditions. from a gender-equity doctrinal perspective, this means that, barring a pertinent biophysical feature that inheres in one sex or the other, similarly situated men and women alike should have the same access to both wellness care and needed medical treatment.9 the evolving definition of health-related disparities accords. who defines disparities or inequities as those “differences in health which are not only unnecessary and avoidable but, in addition, are considered unfair and unjust.”10 nonetheless, our legal understanding of health and health care is not consistent with this proffered tenet, in part, perhaps, because access to health care is in reality a multifactorial inquiry influenced by a variety of laws and policies. in this section, this paper provides a comprehensive overview of health access before turning to law that influences access to care using, predominantly, a “life-cycle” approach rather than focusing on isolated points in time, and highlighting results that are unnecessary, avoidable, unfair, and unjust.11 a. socio-economic access to care: the role of social determinants of health “these will be needless deaths—deaths which should shock our conscience and shame our sensibilities. how do we 9 this paper does not seek to implicate constitutional arguments regarding gender discrimination in every instance of observed gender disparity in access to health care. nonetheless, it is not unimportant that “similarly situated” is a term of art within equal protection and many other doctrines. for an extensive treatise on the meaning and treatment of the phrase in jurisprudence, see generally giovanna shay, similarly situated, 18 geo. mason l. rev. 581 (2011). 10 for background on who’s deliberation on this definition, see margaret whitehead, who, the concepts and principles of equity and health, 6 health promotion int’l 217 (1991). 11 because health does not occur in isolation from the rest of one’s life, a life-cycle approach is most appropriate in determining access to care. see generally steven miles, gender and health insurance, 23 wm. mitchell l. rev. 313, 314-21 (1997) (describing work history and social programs as sources of conflicts and disadvantages by gender that are “magnified because of life cycle effects”). http://dx.doi.org/10.1093/heapro/6.3.217 2016 125 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy explain that the difference between life and death is a matter of dollars?”12 nearly a half-century after the question was posed, the “how” remains a difficult question. the “why” is not: health care is expensive, and so much so that traditionally the two most widely accepted measures of access to care are the status of healthcare insurance coverage and financial barriers.13 yet there is growing appreciation of the importance of the social and physical environment, absent individual constitutional susceptibilities, as the most influential factor on health itself. thus mitigation or elimination of negative social determinants of health (sdoh) is a foundational mechanism for law and policy to increase access to care—or fail to assuage gender-based disparities in access. the u.s.’s healthy people 2020 initiative lists five key areas of sdoh: (1) economic stability; (2) education; (3) social and community context; (4) health and health care; and (5) neighborhood and built environment.14 while access to care can be considered a mere component of the fourth key area, health and health care, it would present an incomplete picture to not consider briefly how the other four key areas of sdoh underlie access to care. 1. economic stability because healthcare insurance acts as a proxy for access to care, a tenet explored in greater detail infra, lack of or 12 ezekiel j. emanuel, the ends of human life: medical ethics in a liberal polity 100 (1994) (quoting senator vance hartke). 13 see, e.g., kaiser family found., putting men’s health care disparities on the map: examining racial and ethnic disparities at the state level 33 (2012), available at https:// kaiserfamilyfoundation.files.wordpress.com/2013/01/8344.pdf [http:// perma.cc/9aaq-jee2] (listing having a regular healthcare provider as the third widely accepted measure of healthcare access). 14 social determinants of health, healthypeople.gov, http://www.healthypeople.gov/2020/topics-objectives/topic/socialdeterminants-health [http://perma.cc/6y2e-67zl] (last visited nov. 1, 2015) [hereinafter healthy people 2020]. healthy people 2020 is a federal interagency population health workgroup that seeks, inter alia, to achieve heath equity. http://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health http://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health 126 indiana health law review vol. 13:1 insufficient coverage tends to create financial barriers to timely care. confounding any unequal distribution of insurance between men and women are inequalities in financial resources. limited resources amongst those of modest income decrease overall health, thereby stimulating a greater need for health care.15 unfortunately, limited financial resources also decrease the ability to acquire that care, as does lower overall health.16 in other words, economic stability is tautologically related to both health and access to care. to the extent that access is about the ability to purchase the goods and services of health care, it is only logical that less money reduces the ability to acquire care. if access to care is understood more broadly, to include adequate transportation, childcare, and ability to miss work, then fewer resources acts as a compounding factor to the access inequity. in terms of both financial ability to purchase care and other resource-related barriers to care, women are more likely to be at disadvantage,17 suggesting that their access is more significantly reduced by economic instability than that of men. further influencing the disparate effect of economics on access to care is that even amongst those with adequate financial resources, women earn less than men across all indicators, including where each is similarly educated, has similar experience, and is in the same occupation.18 whether the earnings gap creates unequal access amongst higher earners in reality is improbable, particularly for relatively inexpensive health services; but, as a philosophical matter, men are privileged relative to women in experiencing 15 see george a. kaplan, the poor pay more: poverty’s high cost to health 8 (2009) (“most diseases are more common among the poor, and those that are not, such as breast cancer, tend to have worse outcomes for poor people.”). 16 see id. at 17 (“because they often lack health insurance benefits from work, many poor and near-poor families have inadequate access to medical care. being poor and uninsured means having less access to preventive care, diagnostic services and treatment, and having, overall, poorer care”). 17 see infra text accompanying notes 50-51. 18 see claudia goldin, a grand gender convergence: its last chapter, 104 am. econ. rev. 1091, 1093-1103 (2014) (presenting findings in earnings by gender over the life cycle and by occupation). http://dx.doi.org/10.1257/aer.104.4.1091 2016 127 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy lessened consequences of profession-based economic instability on access to care.19 law seeks to effect economic stability for those of modest income through federal programs such as the supplemental nutrition access program; the women, infants, and children program; and the temporary assistance to needy families program. concordant with the supposition that women’s access to care is disproportionately affected by economic stability, each of these programs has overwhelmingly higher enrollment by women.20 this suggests either that women’s economic misfortune is more likely to be mitigated or, more probable given the low actual value provided by these programs, women are indeed suffering more from economic instability and, thus, in access to care. 2. education educational attainment is a strong indicator of overall health, and lack thereof thus plays a unique role in defeating access to health care across both genders.21 for example, 19 see michael daly et al., a social rank explanation of how money influences health, 34 health psychol. 222, 223 (2015) (distinguishing the material and psychosocial health effects of financial resources, and finding that each positively correlates with improved health, including through increased access). 20 adult men are not eligible for wic benefits, though their children may be even in the absence of the mother. see, e.g., u.s. dep’t of agric., characteristics of supplemental nutrition assistance program households: fiscal year 2011 xvi (2012), available at http:// www.fns.usda.gov/sites/default/files/2011characteristics.pdf [http:// perma.cc/3bux-8sa9] (“in fiscal year 2011, . . . [a]bout 62 percent of [participating] nonelderly adults were women, as were 66 percent of elderly adults.”); gene falk, temporary assistance for needy families (tanf): size and characteristics of the cash assistance caseload 5 (2014), available at https://www.fas.org/sgp/crs/misc/ r43187.pdf [http://perma.cc/gfb5-4vv4] (“in fy2011, 84.7% of adult recipients were women.”). 21 e.g., why does education matter so much to health?, robert wood johnson found. (mar. 2013), http://www.rwjf.org/content/dam/ farm/reports/issue_briefs/2012/rwjf403347 [http://perma.cc/7xuv-fr32] (giving an overview of studies showing that the better educated live longer, are less likely to have and die from common acute and chronic diseases, are less likely to be overweight or obese, and are less likely to engage in health-harming behaviors). http://psycnet.apa.org/doi/10.1037/hea0000098 128 indiana health law review vol. 13:1 higher education is correlated with both lower incidence of disease and lower mortality.22 but how well one does in school can inform access to care on a gendered basis because higher educational performance by women is not associated with higher pay relative to men.23 recent shifts in the college graduation rate norms may result in increases in private healthcare insurance coverage for women and proportional decreases for men. education positively correlates with healthcare insurance coverage for both genders, regardless of whether or not an employer provides such a plan.24 that is, individuals with at least a baccalaureate degree are more likely to be insured than those with only a high school education even when employed by a business that does not offer healthcare insurance.25 given that women now enroll in college in significantly higher numbers than men,26 it might expected that the former will experience a growth in healthcare coverage relative to the latter. 3. social and community context the effects on health of the social and community environment are divided into social cohesion, civic 22 id. 23 michael t. french et al., what you do in high school matters: high school gpa, educational attainment, and labor market earnings as a young adult, 41 eastern econ. j. 370, 376—82 (2015). see also jillian berman, female 'a+' students end up making as much as male 'c' students, huffington post (may 23, 2014, 7:31 am), http://www.huffingtonpost.com/2014/05/23/gpa-income_n_5373078.html [http://perma.cc/x84s-cusm] (providing a sex-based graph of the final results of aforementioned study of earnings relative to high school grade point average). 24 hubert janicki, u.s. census bureau, employment-based health insurance: 2010, at 13 (2013), available at https:// www.census.gov/prod/2013pubs/p70-134.pdf [http://perma.cc/4hmf68vp]. 25 id.; goldin, supra note 18, at 1091-92. 26 see mark hugo lopez & ana gonzalez-barrera, women’s college enrollment gains leave men behind, pew research center (mar. 6, 2014), http://pewrsr.ch/1qcklfe [http://perma.cc/z5bx-hfyt] (“by 2012, the share of young women enrolled in college immediately after high school had increased to 71%, but it remained unchanged [since 1994] for young men at 61%.”). http://www.huffingtonpost.com/2014/05/23/gpa-income_n_5373078.html http://pewrsr.ch/1qcklfe http://dx.doi.org/10.1057/eej.2014.22 2016 129 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy participation, perceptions of discrimination and equity, and incarceration and institutionalization.27 these categories are pertinent to disparities in access to care insofar as social interaction affects a person’s ability and willingness to obtain needed health care. although generally a more social than legal concept, cultural expectations are a significant confounder that affect perception of health and health risks, and that may be formally codified or informally reinforced through legal tolerance of a practice. for example, culturally bound illnesses—those that “the patient perceives from a sociocultural perspective,” as opposed to “what the physician diagnoses from a biomedical understanding”—inform health-seeking behaviors.28 a subsequent reduction in access to care may occur because legal restrictions override the cultural instinct to seek or avoid care, or they may interfere with the availability of culturally appropriate care. that is, because culturally bound illness generally needs a culturally appropriate healthcare provider, regulation of entry into the practice of medicine can render such care difficult to find.29 access to care necessarily suffers when healthcare providers are unavailable. any effect on access, however, is experienced by all members of the subpopulation regardless of gender. dissimilarly, women have a disproportionate limitation on access to care where society tends to place them in a subordinate position.30 often this hierarchy is reinforced by 27 healthy people 2020, supra note 14. 28 juan carlos belliard & johnny ramírez-johnson, medical pluralism in the life of a mexican immigrant woman, 27 hisp. j. behav. sci. 267, 269 (2005). 29 see id. at 278 (describing an interviewee’s rejection of the idea of going to a traditional clinic for a culturally bound illness because “doctors do not understand those diseases”). 30 see, e.g., farzaneh roudi-fahimi, gender and equity in access to health care services in the middle east and north africa, pop. reference bureau, http://www.prb.org/publications/articles/2006/ genderandequityinaccesstohealthcareservicesinthemiddleeastandno rthafrica.aspx [http://perma.cc/z6us-jtx3] (last visited nov. 1, 2015) (describing how a culture with a tradition of strong gender roles affects the perception of health by women); who, health in all policies training manual 28 (2015) [hereinafter who hiap] (“in some countries, gender can make a significant difference due to social attitudes about the value of men and women. for example, parents might be more http://dx.doi.org/10.1177/0739986305278130 130 indiana health law review vol. 13:1 discriminatory law and policy, or through informal mechanisms of intolerance, such as gender bias by providers.31 the resultant reduction in access to care can be a result of socio-legal control of women’s movements and time, or simply a socially ingrained tendency to minimize, or failure to recognize, certain health issues.32 at the same time, social notions of “machismo” can lessen men’s access to care by simultaneously encouraging them to engage in health-harming behaviors and also discouraging them from seeking health care.33 in both instances, the requisite health care may be otherwise available, and access is reduced merely through social construct. additionally, to the extent that incarceration informs the social context of health, institutionalization achieves increases in access to care for the uninsured, though certainly not in an ideal way. on the other hand, the criminal justice system can limit access to care insofar as it may restrict reproductive choices as a condition of probation or parole, which may be a penalty more frequently prescribed for men while more broadly affecting women.34 likely to take a son to get immunized than a daughter because of social customs that value men over women.”). 31 david gomez et al., gender-associated differences in access to trauma center care: a population-based analysis, 152 surgery 179, 184 (2012). 32 e.g., roudi-fahimi, supra note 30 (noting that reproductive health is frequently ignored by women in the middle east and north africa unless it interferes with childbearing). 33 see kristen w. springer & dawne m. mouzon, “macho men” and preventive health care: implications for older men in different social classes, 52 j. health & soc. behav. 212 (2011) (comparing the effects of masculinity on men across various socio-economic statuses). 34 rachel roth, “no new babies?”: gender inequality and reproductive control in the criminal justice and prison systems, 12 am. u. j. gender soc. pol'y & l. 391, 392-93 (2004) (noting that “to the small extent that appellate courts have been willing to uphold sex or fertilityrelated conditions of probation, they have done so with respect to men” but arguing that such orders “can only be carried out on the backs of women.”). http://dx.doi.org/10.1016/j.surg.2012.04.006 http://dx.doi.org/10.1177/0022146510393972 2016 131 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy 4. neighborhood and built environment the built environment concerns the physical space in which one lives, works, and plays. from an access to care perspective, local availability of a sufficient number and type of healthcare providers is perhaps the most significant indicator of the effect of the built environment. in general, women are less likely than men to have access to outpatient services, specialized inpatient care, and trauma centers.35 as a normative matter, however, men and women do not seek preventative health care in equal numbers, and men are less likely to receive preventative care than women. how much less likely? a 2001 study by the centers for disease control and prevention (cdc) found that “[t]he rate of visits by women for non-illness was 100 percent higher than among men, after controlling for age and removing pregnancyrelated visits.”36 a decade later, the results scarcely changed. the most recent such cdc study found a preventative care visit rate for women of 82.9 visits per one hundred persons and a rate for men of 46.8 visits per one hundred persons, a difference still approaching one hundred percent.37 men are also significantly less likely to have a dedicated primary care physician.38 although gender-based differences in access to care are almost certainly multifactorial, lack of physical proximity to providers, a result of the built environment, necessarily contributes.39 b. financial access to care: the role of insurance “in 1900, the average american spent $5 a year on health care ($100 in today's money). no one had health insurance, 35 gomez, et al., supra note 31, at 179, 181-84. 36 kate m. brett & catharine w. burt, utilization of ambulatory medical care by women: united states, 1997-98, 12 (2001), available at http://www.cdc.gov/nchs/data/series/sr_13/ sr13_149.pdf [http://perma.cc/wh4s-9wrb] (emphasis added). 37 chun-ju hsiao et al., national ambulatory medical care survey: 2007 summary 4 (2010), available at http://www.cdc.gov/nchs/ data/nhsr/nhsr027.pdf [http://perma.cc/rnx8-uuql]. 38 id. at 15. 39 samina t. syed et al., traveling towards disease: transportation barriers to health care access, 38 j. cmty. health 976, 990 (2013). http://dx.doi.org/10.1007/s10900-013-9681-1 132 indiana health law review vol. 13:1 because you don't need insurance for something that costs $5 a year.”40 in general, it might be said that in order to access any service, one must be able to pay for it. health care in the united states is no exception, as it is currently financed and delivered, but the availability of healthcare insurance, or other health plan, begins to render individual fiscal ability to buy care as unnecessary as it was before such insurance existed. indeed, in 2014 out-of-pocket contributions constituted only 10.9% of healthcare expenses, including copayments, deductibles, and other costs not covered by insurance.41 these statistics do not suggest that insurance always makes all care affordable, but rather to acknowledge health insurance as arguably the most important consideration in access to care, as well as a proxy for the same.42 thus, this subsection explores the facilitation of access to health care via insurance. 1. the prevalence of employer-based group insurance the beginnings of healthcare insurance in the united states are well-documented,43 but it is worth noting that it is 40 alex blumberg & adam davidson, accidents of history created u.s. health system, nat’l pub. radio (oct. 22, 2009, 3:28 pm et), http://www.npr.org/templates/story/story.php?storyid=114045132 [http://perma.cc/v226-n4ja]. 41 the percentage given was derived by dividing the federal government’s official tally of out-of-pocket expenses ($329,819,000,000), defined in the text, by total expenditures ($3,031,292,000,000). see ctr. medicare & medicaid serv., u.s. dep’t of health & human serv., national health expenditures by type of service and source of funds, cy 1960-2014 (2015), available at http://www.cms.gov/researchstatistics-data-and-systems/statistics-trends-and-reports/ nationalhealthexpenddata/nationalhealthaccountshistorical.html. 42 this statement is a common understanding. see, e.g., kaiser family found., women’s health insurance coverage (2014) [hereinafter kff women’s health insurance coverage], available at http://files.kff.org/attachment/fact-sheet-womens-health-insurancecoverage [http://perma.cc/z9d8-uxzw] (“health insurance coverage is a critical factor in making health care affordable and accessible . . . .”). 43 see generally arthur daemmrich, u.s. healthcare reform and the pharmaceutical market: projections from institutional history, 15 pharms. pol’y & l. 137 (2013) (giving an overview of the history of healthcare insurance in the u.s.). http://www.npr.org/templates/story/story.php?storyid=114045132 http://files.kff.org/attachment/fact-sheet-womens-health-insurance-coverage http://files.kff.org/attachment/fact-sheet-womens-health-insurance-coverage http://dx.doi.org/10.3233/ppl-130367 2016 133 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy a relatively recent invention—as is the immense cost of health care. whereas other forms of insurance date to the famous marketplace at lloyd’s in the seventeenth century,44 the first individual healthcare insurance was a limited, local plan that did not begin until the mid-nineteenth century.45 group healthcare insurance, soon called “blue cross” and followed by its future partner “blue shield,” did not commence until 1929.46 more than a decade later, healthcare insurance began to be provided widely by employers when it became a standard part of the benefits package during the second world war.47 notably, the need to attract women to the workforce catalyzed the availability of insurance for employees.48 the proliferation was further fed by increasingly business-friendly tax treatment of the benefit.49 today, however, women are less likely than men to have coverage provided by an employer, despite the fact that women work for employers offering healthcare insurance in higher proportion than men.50 this may be because women— and especially those who are mothers—are more likely than men to be employed on a part-time basis; yet fewer benefits, including healthcare insurance, are typically available for 44 see ken brownlee, history of adjusting-part 3: the great fire of london and the “writing under” principle, claims mag., mar. 2014, at 60 (noting that by february 1688 “both lloyd’s coffee house and losses covered by insurance had already become synonymous”). 45 daemmrich, supra note 43, at 138. 46 id. at 139. 47 id. 48 see id. at 139 (noting that wage controls discouraged higher salaries causing benefits as healthcare insurance to become more generous); claudia goldin, the role of world war ii in the rise of women’s work 3 (nat’l bureau of econ. research, working paper no. 3202, 1989) (describing “a variety of mechanisms” that were used to increase the numbers of women working during world war ii), available at http://www.nber.org/papers/w3203.pdf. [http://perma.cc/72pz-gjef]. 49 see blumberg & davidson, supra note 40 (noting the first changes to the internal revenue code were in 1943); daemmrich, supra note 43, at 139 (describing additional changes in 1954). 50 hubert janicki, employment-based health insurance: 2010, u.s. census bureau 6 (feb. 2013), https://www.census.gov/ prod/2013pubs/ p70-134.pdf [http:/perma.cc/x49n-lp5l]. http://www.nber.org/papers/w3203.pdf 134 indiana health law review vol. 13:1 part-time work.51 women are also more likely to be employed in lower valued jobs with fewer benefits.52 indeed, 22% of women with private insurance receive that coverage through a spouse’s employer, and 30% are covered as the employee.53 in contrast, only 13% of men are dependent on their spouse for employer-based healthcare insurance, while 44% are provided coverage as the employee.54 in total, however, 55% of the u.s. population in 2011 had employment-based healthcare insurance.55 amongst those without such coverage, cost is more likely to be cited as a prohibitive factor by men rather than women, but ineligibility for and denials of coverage affect similarly non-elderly adults regardless of gender.56 the patient protection and affordable care act of 201057 (ppaca) sought to remedy some of this disparity through the creation of the small business health options program (shop) exchange.58 to participate in a health benefit exchange as a small business, the entity must employ at least one and no more than 100 employees.59 as with the individual exchanges, discussed immediately infra, states had the option to run their own shop exchange, to cooperate 51 see jeffrey wenger, the continuing problems with part-time jobs, econ. pol’y inst. 1-12 (apr. 24, 2001), http://s3.epi.org/files/page//old/issuebriefs/ib155/ib155.pdf [http://perma.cc/5kgw-6p7l] (finding that women work two-thirds of all part-time jobs, which are also the lowest paying and often lowest skilled with fewer benefits). 52 sabrina matoff-stepp, bethany applebaum, jennifer pooler & erin kavanagh, women as health care decision-makers: implications for health care coverage in the united states, 25 j. health care poor & underserved 1507, 1509 (2014), available at http:// muse.jhu.edu/journals/journal_of_health_care_for_the_poor_and_unders erved/v025/25.4.matoff-stepp.pdf [http://perma.cc/p26x-f5rv]. 53 kff women’s health insurance coverage, supra note 42, at 1. 54 id. 55 janicki, supra note 50, at 1. 56 id. at 13-14. 57 patient protection and affordable care act of 2010, pub. l. no. 111-148 [hereinafter ppaca] (codified as amended in scattered sections of 42 u.s.c.). 58 ppaca § 1311(b)(1)(b) (codified at 42 u.s.c. § 18041 (2015)). 59 ppaca § 1304(a)(2) (codified at 42 u.s.c. § 19024). for the first three years after enactment, each state was given the option of defining a “small business” to include only those employing fewer than fifty employees. ppaca § 1304(a)(3) (codified at 42 u.s.c. § 18024). http://s3.epi.org/files/page/-/old/issuebriefs/ib155/ib155.pdf http://s3.epi.org/files/page/-/old/issuebriefs/ib155/ib155.pdf http://dx.doi.org/10.1353/hpu.2014.0154 2016 135 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy with the federal government to create a shop exchange, or to have the federal government create and manage the shop exchange.60 regardless, they were “designed to assist qualified employers in the state who are small employers in facilitating the enrollment of their employees in qualified health plans offered in the small group market in the state.”61 however, a november 2014 report by the government accountability office found that after the first six months, shop enrollment in the eighteen states that created their own shop (instead of using the federal system) included only 76,000 individuals in plans purchased through fewer than 12,000 employers.62 the low enrollment may be attributed to delays in implementation until 2016.63 numbers for enrollment by men versus women are not yet available.64 all of these factors together mean the employment-based healthcare insurance market favors men in creating financial access to healthcare providers and access to healthcare overall.65 law supports this result through direct regulation of the market, including by not requiring that all employees receive employment-based healthcare coverage. to the extent that legal protections for benefits exist for full-time employees, they extend to part-time employees only in theory.66 and as noted above, women are significantly more likely than men to work in part-time positions. 60 ppaca § 1311(b)(1)(b) (codified at 42 u.s.c. § 18041 (2015)). 61 id. 62 u.s. gov’t accountability office, small business health insurance exchanges: low initial enrollment likely due to multiple, evolving factors 12 (2014), available at http:// www.gao.gov/assets/670/666873.pdf [http://perma.cc/xg7b-ptgb]. 63 patient protection and affordable care act; exchange and insurance market standards for 2015 and beyond; final rule, 79 fed. reg. 30240, 30249-50 (may 27, 2014) (codified at 45 c.f.r. § 155.705(b)(2)-(3) (2015)). 64 see generally u.s. gov’t accountability office, supra note 62. 65 gender differences and the aca, ctr. health & econ. tbl. 5 (apr. 16, 2014), http://healthandeconomy.org/gender-differences-and-the-aca/ [http://perma.cc/zdl2-jg6m]. 66 vai io lo, atypical employment: a comparison of japan and the united states, 17 comp. lab. l.j. 492, 515-16 (1996) (“[l]egal protections http://healthandeconomy.org/gender-differences-and-the-aca/ 136 indiana health law review vol. 13:1 2. the contemporary non-group insurance market the private healthcare insurance schema was fundamentally altered by ppaca and done deliberately so.67 the act’s insurance exchanges, later rebranded the health insurance marketplace (him), have the potential to provide a robust alternative to traditional employer-based insurance through both the individual him and the group insurance shop exchange. whereas in 2013, the year before the him provisions took effect, equal proportions of men and women purchased insurance on their own,68 by the end of the second enrollment period in early 2015, fewer men had purchased coverage through the him: fifty-four percent of enrollees were women.69 total enrollment is expected to grow to include another ten million persons by the end of 2016, for regular employees under federal law are theoretically applicable to nonregular employees. [but] nonregular employees . . . receive inferior treatment in various aspects of employment, either because they fail to satisfy certain threshold requirements or because exemptions exist which permit employers to treat nonregular workers differently than regular workers.”). 67 see, e.g., william p. brandon & keith carnes, federal health insurance reform and “exchanges”: recent history, 25 j. health care for the poor & underserved xxxii, xxxii (2014) (calling the hims the “major national innovation” of the legislation). 68 see health insurance coverage of women, kaiser family found. 19-64 (2013), http:// kff.org/other/state-indicator/nonelderly-adultwomen/ [http://perma.cc/ 696q-ksvx] [hereinafter kff coverage of women] (showing that 8% of women nationwide were enrolled in private insurance that is not employer-sponsored in 2013); health insurance coverage of men, kaiser family found. 19-64 (2013), http://kff.org/other/state-indicator/nonelderly-adult-men/ [http://perma.cc/h3qu-kry7] [hereinafter kff coverage of men] (showing that 8% of men nationwide were enrolled in private insurance that is not employer-sponsored in 2013). 69 health insurance marketplaces 2015 open enrollment period: march enrollment report, dep’t of health & human serv. 12 (mar. 10, 2015), http://aspe.hhs.gov/sites/default/files/pdf/83656/ib_2015mar_ enrollment.pdf [http://perma.cc/gad7-mxcr], but cf. liz hamel et al., survey of non-group health insurance enrollees, kaiser family found. (jun. 19, 2014), http://kff.org/health-reform/report/survey-of-nongroup-health-insurance-enrollees/ [https://perma.cc/end2-b75k] (“[g]ender distribution is similar for those in aca-compliant plans purchased inside and outside the marketplace.”). http://kff.org/other/state-indicator/nonelderly-adult-men/ http://perma.cc/h3qu-kry7 http://perma.cc/gad7-mxcr http://dx.doi.org/10.1353/hpu.2014.0022 2016 137 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy potentially exacerbating the disparity.70 however, with the pool of uninsured women shrinking at a faster rate than that of men, those additional enrollees in him plans may statistically be more likely to be men. to assist with the purchase of healthcare insurance in the him, a system of subsidies and tax credits was established by ppaca.71 the monies were designed to benefit those between 100% and 400% of the federal poverty guideline.72 those above 400%, or $47,080 for a single adult and $97,000 for a family of four in 2015,73 were presumed to not require help with the purchase of insurance and/or to be already covered. the subsidies and credits are generally not considered generous for those between 100% and 138%, where coverage was intended to be provided by medicaid, because the financial assistance is graduated proportionate to income, and the raw dollar amount may be insufficient to purchase coverage.74 thus in states that did not expand medicaid, discussed more fully infra, people with incomes under 138% of the federal poverty guidelines are effectively disenfranchised from healthcare coverage, even in the him. the cost-reduction assistance in the him favors women superficially, with subsidies averaging $9,000 for women and $8, 250 for men.75 the variation, however, should not have significant effect on access to care for one gender more than the other because the cost-reduction system is based on income proportional to household size. 70 insurance coverage provisions of the affordable care act: cbo’s march 2015 baseline, cong. budget office 4 (mar. 9, 2015), https://www.cbo.gov/sites/default/files/cbofiles/attachments/43900-201503-acatables.pdf [http://perma.cc/3zkn-gelr]. 71 ppaca § 1402(b) (codified at 42 u.s.c. §18071 (2015)). 72 id. 73 80 fed. reg. 3236, 3237 (jan. 22, 2015). 74 see, e.g., phil galewitz, in states that don’t expand medicaid, some of the uninsured may still get help, kaiser health news (aug. 11, 2013), http://kaiserhealthnews.org/news/income-projections-lowincome-obamacare-state-medicaid-marketplace-exchange/ [http:// perma.cc/vq2x-d7um] (noting that “even if people with incomes at the poverty level qualify for subsidies for private insurance, the coverage might still be unaffordable . . . because they would owe as much as 2 percent of their income towards the cost of the premium and could still have co-pays and deductibles.”). 75 gender differences and the aca, supra note 65, at tbl. 3. http://kaiserhealthnews.org/news/income-projections-low-income-obamacare-state-medicaid-marketplace-exchange/ http://kaiserhealthnews.org/news/income-projections-low-income-obamacare-state-medicaid-marketplace-exchange/ 138 indiana health law review vol. 13:1 the recent case of king v. burwell76 could have fundamentally altered this analysis, however. at issue was the applicability of the system of subsidies and credits to states who opted not to run their own him. the plaintiffs argued that the plain language of ppaca makes the costreduction scheme available only in states where the federal government is not a partner or in charge of the him.77 a holding in favor of the plaintiffs would have eliminated the subsidies and tax credits in as many as thirty-four states, causing an estimated $28.8 billion in lost subsidies and credits for over 9 million people.78 the majority of him plan beneficiaries would thus no longer have been able to afford their plans, potentially shrinking the him by threequarters.79 so while residents of washington, d.c., and the sixteen states that manage their own him would have been unaffected with regard to the subsidies and credits, the resultant increase in premiums caused by the inevitable loss 76 king v. burwell, 759 f.3d 358 (4th cir. 2014) (u.s. argued mar. 4, 2015). companion cases include halbig v. burwell, 758 f.3d 390 (d.c. cir. 2014), vacated, and oklahoma ex rel. pruitt v. burwell, 51 f. supp.3d 1080 (e.d. okla. 2014). 77 king, 759 f.3d. at 364. in an opinion that was vacated, the halbig court held in favor of the similarly situated plaintiffs. halbig, 758 f.3d at 412. the pruitt court held in favor of the similarly situated plaintiffs. pruitt, 51 f.supp.3d at 1093. 78 linda j. blumberg et al., urban inst., the implications of a supreme court finding for the plaintiff in king vs. burwell: 8.2 million more uninsured and 35% higher premiums, robert wood johnson found. 2-5 (jan. 2015), http://www.urban.org/sites/default/files/ alfresco/publication-pdfs/2000062-the-implications-king-vs-burwell.pdf [http://perma.cc/8upx-3bx9], cf. evan saltzman & christine eibner, the effect of eliminating the affordable care act’s tax credits in federally facilitated marketplaces, rand corp. 3-4 (2015), http:// www.rand.org/content/dam/rand/pubs/research_reports/rr900/rr980/r and_rr980.pdf [http://perma.cc/u8lx-r82t] (predicting a loss of 9.6 million people from the him). 79 see blumberg et al., supra note 78, at 5 (75% decrease); saltzman & eibner, supra note 78, at 5 (70%). 2016 139 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy of healthy people in the him would have negatively affected participants nationwide.80 had the immediate destabilization of the insurance market oft predicted occur,81 the rippling effects may have drowned access to care for men and women alike. but such a ruling was more likely to have a disparate effect on the access to care of women for two reasons. first, women are more likely to be uninsured and are also more likely to be poor,82 and the greatest direct consequence of a plaintiff victory in king would have been in states where the highest proportion of uninsured and low-income people live.83 second, and as noted supra, women enrolled in him plans in greater numbers. reasons for the disproportionate enrollment are multifactorial. women are generally the healthcare decisionmakers in any given household. the u.s. department of labor estimates that women make 80% of such decisions while other studies suggest the rate is as high as 90%.84 unsurprisingly, given the overwhelming nature of the disparity, the skewed phenomenon is not new.85 presumably, then the generations of greater experience with healthcare decisions translates to a greater likelihood of enrollment in a 80 blumberg et al., supra note 78, at 7; saltzman & eibner, supra note 78, at 5. 81 e.g., blumberg et al., supra note 78, at 7 (terming such a scenario a “death spiral”); saltzman & eibner, supra note 78, at 6 (“death spiral”). the supreme court itself characterized the potential as a “death spiral,” using the term no fewer than twice in the majority opinion. king, 135 s. ct. 2480, 2482 (2015). 82 see infra text accompanying notes 15-20. 83 saltzman & eibner, supra note 78, at 5-6. these states typically have conservative governors who are ideologically opposed to ppaca. 84 general facts on women and job based health, dep’t labor (dec. 2013), http://www.dol.gov/ebsa/newsroom/fshlth5.html [http://perma.cc/ v3c6-sbz7]; matoff-stepp, applebaum, pooler & kavanagh, supra note 52, at 1508. 85 see generally, e.g., dana hostetler, women: health care’s new decision makers, 57 j. am. med. rec. ass’n 18 (1986) (describing the first annual conference of the american college of healthcare executives to discuss the role of women as administrators and consumers of health care). http://www.dol.gov/ebsa/newsroom/fshlth5.html 140 indiana health law review vol. 13:1 him plan where other factors previously prevented insurance coverage. for instance, as a result of ppaca, insurers are prohibited from denying coverage based on a preexisting illness.86 while this provision has broad applicability to all persons, women in particular were susceptible to coverage exclusions and increased premiums simply by virtue of having a uterus. one prominent example during the legislative debate over ppaca was the story of one thirtynine-year-old woman who was expressly advised by her insurance company that only sterilization would make her insurable due to a prior medical history that included a single caesarean section birth.87 another commonly cited example was the insurance declaration of domestic violence, which affects women disproportionately, as a disqualifying preexisting condition.88 the correlation between womanhood and these kinds of coverage denials was so strong that, once the ppaca preclusion took effect, the then-secretary of health and human services famously tweeted, “[b]eing a woman is no longer a pre-existing condition.”89 similarly, the wide-scale practice of gender rating by insurance companies meant that women were more likely than men to be priced out of the non-group healthcare insurance market. women between the ages of eighteen and sixty-four were charged as much as 57% more than men, even with maternity coverage excluded.90 across the nation, this 86 ppaca, pub. l. no. 111-148, § 2704 (codified as amended at 42 u.s.c. § 300gg (2015)). 87 denise grady, after caesareans, some see higher insurance cost, n.y. times (june 1, 2008), http://www.nytimes.com/2008/06/01/health/ 01insure.html?_r=1&scp=1&sq=peggy+robertson&st=nyt [http:// perma.cc/8t4x-gynm]. 88 e.g., ryan grim, when getting beaten by your husband is a preexisting condition, huffington post (may 25, 2011, 2:05 pm), http://www.huffingtonpost.com/2009/09/14/when-getting-beaten-byyo_n_286029.html [http://perma.cc/wrg2-zcvc] (noting that eight states allow domestic violence to be considered a preexisting condition). 89 kathleen sebelius, twitter (may 10, 2013, 12:10 pm), https:// twitter.com/secsebelius/status/332935813069426689 [http://perma.cc/ hl6h-vk29]. 90 turning to fairness: insurance discrimination against women today and the affordable care act, nat’l women’s l. ctr. 18 (2012), http://www.huffingtonpost.com/2009/09/14/when-getting-beaten-by-yo_n_286029.html http://www.huffingtonpost.com/2009/09/14/when-getting-beaten-by-yo_n_286029.html 2016 141 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy practice was estimated as costing women an aggregate one billion dollars per year, again expressly excluding maternity benefits.91 by precluding gender rating and consideration of preexisting conditions,92 ppaca enhanced the ability of women to afford and qualify for healthcare insurance coverage, suggesting that women’s higher enrollment in him plans may level off as those previously disenfranchised acquire coverage. ppaca also increased access to preventative care by requiring that no co-payment be charged for listed services regardless of whether the insured has met his or her deductible. a variety of these provisions are particularly relevant to or expressly designed for women. eleven preventative health services apply specifically to women: six services for pregnant women; folic acid supplements for women of childbearing age; select sexually transmitted infection screening; breast and cervical cancer screening; domestic violence counseling; and contraception.93 only one test—a one-time screening for abdominal aortic aneurysm— applies to men only.94 importantly, several of these gender-restricted services regard preventative care for conditions that are not necessarily gender-specific. breast cancer, for instance, can and does occur in men; the national institutes of health even maintains a website specifically on the subject.95 yet denials http://www.nwlc.org/sites/default/files/pdfs/nwlc_2012_turningtofairness _report.pdf [http://perma.cc/4g6r-3f6z]. 91 id. at 7. 92 ppaca, pub. l. no. 111-148, § 1557 (2010) (codified as amended at 42 u.s.c. § 18116 (2015)). 93 preventive health services for women, healthcare.gov, https://www.healthcare.gov/preventive-care-women/ [http:// perma.cc/98b6-wlau] (last visited nov. 1, 2015). although advertised as twenty-six services for women, eleven of those twenty-six are available to men also without cost-sharing. preventive health services for adults, healthcare.gov, https://www.healthcare.gov/ preventive-care-adults/ [http://perma.cc/pe4s-3bdf] (last visited nov. 1, 2015). 94 preventive health services for adults, supra note 93. 95 male breast cancer treatment, nat’l inst. health (nov. 25, 2014), http://www.cancer.gov/cancertopics/pdq/treatment/malebreast/ patient#_83 [http://perma.cc/yjv8-j4kz]. breast cancer accounts for 1% of all cancers in men and male breast cancer is approximately 2% of all breast cancers in the united states, helmneh m. sinesha et al., http://www.nwlc.org/sites/default/files/pdfs/nwlc_2012_turningtofairness_report.pdf http://www.nwlc.org/sites/default/files/pdfs/nwlc_2012_turningtofairness_report.pdf 142 indiana health law review vol. 13:1 of access to breast-cancer-related care for men have been reported since the passage of ppaca. in one self-pay case, a florida man, whose primary care physician suspected breast cancer, was denied a mammogram by six different facilities, all of whom were offering discounted or free mammograms as part of breast cancer awareness month campaigns.96 apparently the discounts were for females only. of the six tests covered for only pregnant women without cost-sharing, only two are irretrievably tied to motherhood— breastfeeding comprehensive support and counseling, and rh incompatibility screening—though admittedly the effect of the rest on fetal development creates a stronger justification for shifting resources toward greater coverage.97 but while men may not get cervical cancer, they are subject to other gender-specific cancers, none of which have mandated cost-free coverage for screenings. indeed, the same virus attributed to cervical cancer also causes penile and testicular cancers, though with less mortality and morbidity.98 similarly, men experience domestic violence as black/white disparities in receipt of treatment and survival among men with early-stage breast cancer, j. clinical oncology 1, 1 (2015). 96 christy dimond, southwest florida man denied mammogram because of gender, fox4 news (oct. 8, 2013), http:// www.scrippsmedia.com/fox4now/news/southwest-florida-man-deniedmammogram-because-he-is-a-man-226976931.html [http://perma.cc/ ew2b-gth2]. 97 the cost-free services for pregnant women are: (1) anemia screening; (2) breastfeeding support and counseling; (3) diabetes screening; (4) hepatitis b screening; (5) rh incompatibility screening; and (6) urinary tract or other infection screening. preventive health services for women, supra note 93. as with services for women versus men, the number advertised for expectant mothers—11—is significantly greater than the number actually restricted to the designated group. see supra note 93 and accompanying text. 98 xiaocheng wu et al., human papillomavirus-associated cancers: united states, 2004-2008, morbidity & mortality weekly report 25861 (apr. 20, 2012), http://www.cdc.gov/mmwr/pdf/wk/mm6115.pdf [http://perma.cc/7mmc-2rgn]. the human papilloma virus can also cause anal and oropharyngeal (base of the throat) cancers in all people regardless of gender, id. there are no conclusive methods of screening for oropharyngeal or penile cancers, but there is a test for anal cancer for men and women that is comparable to the test for cervical cancer in women, see hpv and cancer, am. cancer soc’y 4-5 (jan. 2015), http://www.cancer.org/acs/groups/content/@editorial/documents/docume http://www.cdc.gov/mmwr/pdf/wk/mm6115.pdf http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044199.pdf http://dx.doi.org/10.1200/jco.2014.60.5584 2016 143 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy well as women, and they may actually have a reduced access to care relative to women because men tend to be more reticent to seek help for domestic violence.99 they may also be more likely to be denied services or disbelieved.100 inversely, yet similarly, women as well as men die from abdominal aortic aneurysm, a condition referenced supra as the sole cost-share-free benefit ppaca bestows on men. routine screening has been medically recommended for women at risk, including those over the age of sixty-five who smoke or have heart disease.101 yet this screening is not only not free for all women, even women with high risk are subject to co-payment because by law only men are required to be screened without charge. these sorts of gender-based distinctions in facilitating access to care have failed judicial review on an equal protection basis at least once. in woods v. horton, several male victims of domestic violence sued the state of california after they were denied specialized health and social services nt/acspc-044199.pdf [http://perma.cc/8nmk-lgyp]. limitations in medical technology that happen to occur along gender lines is not considered a disparity herein, unless some extraneous factor exists, such as funds diverted to research for only one gender. 99 at least one scholar has found that “women, both generally and in clinical samples, report perpetrating violence against their male intimate partners at rates similar to men.” mary beth phelan et al., domestic violence among male and female patients seeking emergency medical services, 20 violence & victims 187, 189 (2005). additionally, “compared to men, women are more likely to seek health care services for abuse-related injuries than are men.” id. 100 for perspective on the male victim’s experience as perceived by the victim, the public, the police, and the female perpetrator, and how each of these can represent a roadblock to services, see caroletta a. shuler, male victims of intimate partner violence in the united states: an examination of the review of literature through the critical theoretical perspective, 5 int’l j. crim. just. sci. 163, 164-67 (2010). 101 see brian g. derubertis et al., abdominal aortic aneurysm in women: prevalence, risk factors, and implications for screening, 46 j. vascular surgery 630, 630 (2007) (“although the medical literature suggests a low prevalence rate of aaa in women in the general population, . . . subgroups of women can be identified that are at a substantially increased risk of aneurysmal disease. . . . these data support the notion that women with such risk factors should be considered for aaa screening.”). http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044199.pdf http://dx.doi.org/10.1891/0886-6708.2005.20.2.187 http://dx.doi.org/10.1016/j.jvs.2007.06.024 144 indiana health law review vol. 13:1 related to their victimization expressly on the basis of their gender.102 on appeal from a denial of the plaintiff’s petition, the court held that there is no compelling state interest in funding a domestic violence program for only women, and thus that the programs fail strict scrutiny analysis.103 as the court noted in response to the state’s assertion that women have a greater need and that insufficient resources require rationing, “equal protection is not concerned with numbers.”104 although our healthcare system is ostensibly and fairly concerned with one very important number—cost—what is clear is that only some gender-based access to care determinations are a result of variations in biophysical or sex-based needs.105 other access rules, such as the majority of cost-free screening provisions of ppaca, are more like the programs in woods. that is, they are gender-based distinctions that create inequities in access to care that are unnecessary, avoidable, unfair, and unjust, and thus are the epitome of a health disparity. moreover, they exacerbate the already unequal distribution of limited financial resources for enabling access to care by missing the opportunity to address the most severe, or preempt the most costly, healthrelated conditions. with only one such example of cost-free coverage for men, men overall potentially saw a decrease in the affordability of health insurance due to the weighted balance of cost-sharefree benefits for women, combined with another ppaca requirement that all insurance plans cover minimum essential health benefits to include obstetrical care.106 arguing that men should not have to pay for coverage they would never need, some men—and, curiously, a few women, too—were outraged.107 of course, the same argument could 102 woods v. horton, 84 cal. rptr. 3d 332, 337-38 (cal. ct. app. 2008). 103 id. at 346-48. 104 id. at 347. 105 the presumed need for rationing with a concrete example in the context of the right to health is discussed infra at text accompanying notes 228-240. 106 id. at § 1302 (codified as amended at 42 u.s.c. § 18022 (2015)). 107 see, e.g., garance franke-ruta, why is maternity care such an issue for obamacare opponents?, the atlantic (nov. 22, 2013), http://www.theatlantic.com/politics/archive/2013/11/why-is-maternityhttp://www.theatlantic.com/politics/archive/2013/11/why-is-maternity-care-such-an-issue-for-obamacare-opponents/281396/ 2016 145 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy be applied to women who are outside of childbearing age, are infertile, or simply will not have children in the future, all of whom similarly experienced reduced affordability due to the insurance market principle of spreading the risk. this somewhat mitigates the effect on men. nonetheless, one study predicted that all men would see an increase of 11% in premiums and women overall would experience a decrease of 9%.108 in particular, women of childbearing age were anticipated to receive a 13% to 19% decrease in premiums.109 another study found that young men would be particularly susceptible to premium increases of up to 75% due to the combination of the prohibition on gender-rating and the separate limitations on age-rating.110 with only less than two years of him existence as of winter 2015, data are not yet available to support or counter these predictions. despite the efforts to increase the affordability and availability of healthcare insurance, it has become clear that many of ppaca’s mandates of cost-share-free care are religiously and flagrantly violated. the national women’s law center recently examined the 2014 and 2015 certificates of coverage of over one hundred insurance companies in fifteen states, focusing on the insurer’s compliance with ppaca in facilitating access to health care for women.111 care-such-an-issue-for-obamacare-opponents/281396/ [http://perma.cc/ s26n-ycxe] (citing male and female politicians and commentators who complained about the maternity coverage requirement). 108 james t. o’connor, comprehensive assessment of aca factors that will affect individual market premiums in 2014, at 21 (2013), available at http://ahip.org/workarea/downloadasset.aspx?id= 2147491347 [http://perma.cc/3qb6-xn5x]. 109 id. 110 gary claxton, larry levitt, karen pollitz & anthony damico, why premiums will change for people who now have nongroup insurance, kaiser family found. (feb. 6, 2013), http://kff.org/healthreform/perspective/why-premiums-will-change-for-people-who-nowhave-nongroup-insurance/ [http://perma.cc/9whs-5mvj]. 111 state of women’s coverage: health plan violations of the affordable care act, nat’l women’s l. ctr. (2015), http:// www.nwlc.org/sites/default/files/pdfs/stateofcoverage2015final.pdf [http://perma.cc/3vrd-kcal]. the states examined were those who make the coverage certificates publicly available, and include alabama, http://www.theatlantic.com/politics/archive/2013/11/why-is-maternity-care-such-an-issue-for-obamacare-opponents/281396/ http://kff.org/health-reform/perspective/why-premiums-will-change-for-people-who-now-have-nongroup-insurance/ http://kff.org/health-reform/perspective/why-premiums-will-change-for-people-who-now-have-nongroup-insurance/ http://kff.org/health-reform/perspective/why-premiums-will-change-for-people-who-now-have-nongroup-insurance/ 146 indiana health law review vol. 13:1 the violations were broken into multiple bullet points across six categories: (1) maternity coverage, such as the exclusion of maternity coverage for dependent enrollees and the establishment of arbitrary limits on benefits; (2) preventative services coverage, such as the imposition of cost-sharing and the limitation of frequency of wellness visits; (3) abortion coverage, such as the creation of varying coverage based on subsidy status; (4) essential health benefit coverage, such as the establishment of limitations stricter than benchmark coverage and the imposition of waiting periods for certain services; (5) discriminatory benefit design, such as the restriction of coverage based on age and the exclusion of chronic pain treatment; and (6) contraceptive coverage, such as the requirement of cost-sharing or the exclusion of certain methods of birth control.112 while the report explored coverage of women’s health services pursuant to the requirements of ppaca, the instances of noncompliance are significant here insofar as they are limitations on access to care based on the gender of the patient, as all pertain to the effective insurance coverage of mandatory access to health care. that is, while obstetrical services, for example, may be understood as a gender-specific medical need, the barrier to access to care is not based solely on a legitimate biophysical distinction, but instead is a violation of law that seeks to remedy such disparities in access to health care. similarly, the 2014 supreme court decision in the case of burwell v. hobby lobby stores, inc.113 undermines access to california, colorado, connecticut, florida, maine, maryland, minnesota, nevada, ohio, rhode island, south dakota, tennessee, washington, and wisconsin, id. 112 id. at 4-6 (maternity), 6-14 (preventative), 15 (abortion), 16-18 (essential health benefits), 18-20 (discriminatory benefit design). the matter of coverage of contraception was more fully addressed in a second, simultaneously released report, see state of birth control coverage: health plan violations of the affordable care act, nat’l women’s l. ctr. (2015), http://www.nwlc.org/sites/default/files/pdfs/ stateofbirthcontrol2015final.pdf [http://perma.cc/n255-x3tq]. 113 burwell v. hobby lobby stores, inc., 134 s. ct. 2751 (2014). consolidated with this case and ultimately remanded by it were conestoga wood specialties corp. v. sec’y of u.s. dept. of health and human servs., 724 f.3d 377 (3rd cir. 2013), rev’d, 2014 wl 4467879 (3rd 2016 147 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy gynecological care, which is admittedly gender-specific, by subjugating health care access vis-à-vis mandatory costshare-free coverage. at issue were certain forms of contraception that the owners of the plaintiff businesses believe, as a matter of religion, to be abortifacients. these include all types of intrauterine devices and the emergency contraceptive pills plan b and ella.114 regulations pursuant to ppaca require coverage of twenty forms of contraception, including those to which hobby lobby began to object after the act was passed, and it contemplated litigation.115 despite the plain meaning of the term “contraception” to expressly exclude actual abortifacients, thereby rendering any burden on religion a legal (and medical) fiction, the court held in favor of the plaintiffs.116 that holding and subsequent regulation extended the coverage exception already in place for religiously oriented non-profit entities like charities, hospitals, schools, and colleges to for-profit closely held corporations.117 female employees of such entities are still eligible to receive cost-share-free contraceptive coverage through alternative means that do not require cost-sharing by the employer, the insurance plan, or the employee.118 nonetheless, the inability to access this type of health care in regular fashion does represent a barrier to care for women cir. 2014) and autocam corp. v. burwell, 730 f.3d 618 (6th cir. 2013), vacated, 134 s. ct. 2901 (2014). 114 hobby lobby stores, inc. v. sebelius, 723 f.3d 1114, 1125 (10th cir. 2013), aff’d, burwell v. hobby lobby stores, inc., 134 s. ct. 2751 (2014). 115 coverage of certain preventive services under the affordable care act, 78 fed. reg. 39870 (july 2, 2013). hobby lobby covered emergency contraception for a long time and only discontinued coverage as part of its litigation strategy, which it admitted in its pleadings. additionally, it invests significantly in the makers of the contraceptives. see molly redden, hobby lobby's hypocrisy: the company's retirement plan invests in contraception manufacturers, mother jones (apr. 1, 2014, 6:00 am edt), http://www.motherjones.com/politics/2014/04/ hobby-lobby-retirement-plan-invested-emergency-contraception-andabortion-drug-makers [http://perma.cc/bd3a-vnq8]. 116 burwell v. hobby lobby stores, inc., 134 s. ct. at 2759-60. 117 79 fed. reg. 51092 (2014). 118 id. 148 indiana health law review vol. 13:1 employed by these categories of businesses, the breadth of which is unknown.119 in sum, all women are not in fact receiving increased access to preventative care despite the ppaca provisions that expressly sought to remedy gender-based disparities in access. importantly, however, not all of the decreased access to health care experienced by women occurs around services that are based on biophysical distinctions, though arguably the most egregious examples are. from a gender-parity standpoint, these types of distinctions, while clearly not in alignment with genuine gender-distinct medical needs, are not examples of disparities in access to health care that result from dissimilar legal treatment of similarly situated, but gender-opposed, parties. other disparities, including costshare-free coverage of the sole screening available only to men, do unnecessarily represent a greater barrier to access to specific medical treatment by women. likewise, denials of benefits, such as chronic pain treatment, that have a disparate impact on women further defeat access to care. on the other hand, the rather overwhelming prejudice toward increased access to care for women in ppaca may effect lack of affordability of healthcare insurance for men. insofar as insurance is a proxy for access to care, the resulting effect of reduced availability of non-group insurance represents a potential barrier to health care access for men. arguably, however, leveling the playing field does not create disparity. confounding this conclusion, however, is one study that suggests that men actually have a slightly greater access to healthcare providers in the non-group insurance market, a trend that has been predicted to hold.120 nonetheless, a study similar to one by the national women’s law center that considers coverage for all adults would be useful in ascertaining whether the intended increase in 119 the opinion left undefined “closely held,” which has multiple legal definitions. for the conclusion of one news outlet that as many as 60 million employees would fall into the category, see jillian berman, the hobby lobby decision could affect millions of workers, huffington post, http://www.huffingtonpost.com/2014/06/30/hobby-lobby-closelyheld_n_5545064.html [http://perma.cc/9szs-nv6y] (last updated jul. 10, 2014, 9:59 pm). 120 gender differences and the aca, supra note 65, at 5. http://www.huffingtonpost.com/2014/06/30/hobby-lobby-closely-held_n_5545064.html http://www.huffingtonpost.com/2014/06/30/hobby-lobby-closely-held_n_5545064.html 2016 149 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy access to wellness care for men (and also for women on care that is not gender-specific) is indeed being compliantly provided. 3. medicaid [in]efficacy in facilitating access to care in the ppaca era fundamental to the functioning of the him was expansion of the medicaid system.121 since 1965, medicaid has provided a limited safety net of healthcare insurance for select poor citizens.122 a complex system of coverage, medicaid was, before the ppaca expansion provisions, not available with matching federal funds for non-disabled, childless adults without a waiver.123 of the many waivers granted for use of medicaid dollars, one prominent program is the national breast and cervical cancer early detection program.124 according to the cdc, over four million women were served by the program in its first twenty years.125 while the program regulations specify that treatment is available for people of all genders, at least one man was initially denied chemotherapy treatment coverage due to purported state and federal regulations that jointly limited such care to women.126 nonetheless, the program’s very existence is an 121 brandon & carnes, supra note 121, at xxxiii. 122 social security amendments of 1965, pub. l. no. 89-87, 79 stat. 286 (codified as amended at 42 u.s.c. §§ 1396-1396w (2015)). 123 where are states today? medicaid and chip eligibility levels for children and non-disabled adults, kaiser family found. 2 (mar. 2013) https:// kaiserfamilyfoundation.files.wordpress.com/2013/04/799303.pdf [http:// perma.cc/2t7w-h2pe] [hereinafter kff medicaid 2013]. 124 42 u.s.c. §§ 1396a(a)(10)(a)(ii)(xviii), (aa) (2015). 125 millions of underserved women in the u.s. have benefited from cdc’s breast and cervical screening program, ctr. disease control & prevention (aug. 6, 2014), http://www.cdc.gov/media/releases/2014/ p0806-cancer-screening.html [http://perma.cc/jp4e-fe23]. 126 south carolina eventually agreed to cover the treatment. amanda chan, raymond johnson to receive breast cancer treatment coverage, after all, huffington post, http://www.huffingtonpost.com/2011/08/23/ raymond-johnson-breast-cancer-coverage_n_933999.html [http:// perma.cc/apn4-6hpg] (last updated oct. 24, 2011, 5:12 am). the initial coverage denial may have been wrong, however. the text of the breast and cervical cancer prevention and treatment act of 2000, which allowed states to opt into medicaid eligibility for “certain breast or 150 indiana health law review vol. 13:1 example of increased access to expensive care for women who otherwise would be unable to afford screening and treatment, because there is no equivalent program for any other condition. limited waiver programs notwithstanding, the multitude of other requirements for potential parent beneficiaries, such as having a monthly income amount that could literally and easily be counted by the dozen, effectively rendered medicaid nonexistent for most people.127 in both texas and alabama, for example, the income limit for adult eligibility is currently 18% of the federal poverty guideline, a maximum income of $364 per month for a family of four in 2015.128 unsurprisingly, then, only 13% of women and 10% of men were covered by medicaid in 2013.129 ppaca attempted to increase access to care by removing the various restrictions on medicaid eligibility and raising the upper income limit for all households to an effective 138% cervical cancer patients,” provides coverage for “individuals,” breast and cervical cancer prevention and treatment act of 2000, pub. l. 106-354, 114 stat 1381 (2000). nonetheless, the prefatory language describing the act’s intent references only women, as does the cdc’s current website on the program, breast and cervical cancer prevention and treatment act of 2000, ctr. disease control & prevention (nov. 5, 2013), http://www.cdc.gov/cancer/nbccedp/legislation/law106-354.htm [http://perma.cc/5e39-4fs2]. 127 see kff medicaid 2013, supra note 123 (noting in 2013 that “[t]he federal minimum level at which states must cover parents through medicaid today is below poverty in every state and below half of poverty in nearly all states,” meaning that expansion would “significantly increase eligibility for parents” and provide even larger coverage gains for other adults). cf. where are states today? medicaid and chip eligibility levels for adults, children, and pregnant women, kaiser family found. (apr. 2015), http://files.kff.org/attachment/fact-sheetwhere-are-states-today-medicaid-and-chip-2 [http://perma.cc/9wvldqvw] [hereinafter kff medicaid in 2015] (noting in 2015 that in the twenty-two states that have not adopted the medicaid expansion, the median eligibility limit for parents is 44% [of the federal poverty guideline], and, with only one exception, childless adults are ineligible for medicaid, which largely reflects the status prior to expansion under ppaca). forty-four percent of the federal poverty guideline for a fourperson household in 2015 is $889.17 per month. 128 kff medicaid in 2015, supra note 127, at 1. 129 kff coverage of women, supra note 68; kff coverage of men, supra note 68. http://www.cdc.gov/cancer/nbccedp/legislation/law106-354.htm http://files.kff.org/attachment/fact-sheet-where-are-states-today-medicaid-and-chip-2 http://files.kff.org/attachment/fact-sheet-where-are-states-today-medicaid-and-chip-2 2016 151 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy of the federal poverty guideline as of january 1, 2014.130 the purpose of the change was to ensure coverage for those too poor to be sufficiently assisted by the subsidies and tax credits available in the him.131 however, the supreme court ruling in national federation of independent businesses v. sebelius, one of many legal challenges seeking to dismantle ppaca in its entirety, made optional the medicaid expansion.132 with seventeen states rejecting the medicaid expansion option as of fall 2015 and another four merely considering the option,133 healthcare coverage rates remain low for men and women alike in many states. texas, for example, has retained its title as the state with the most uninsured citizens—a whopping 24.4%, or over 6.2 million people—by declining to expand medicaid.134 the texas medicaid roster tracked the national average prior to the enactment of ppaca with men making up only about 40% of enrollees, making texas a good indicator of the proportionate effect of the lack of medicaid expansion on access to care by gender.135 130 ppaca §2001(a), 42 u.s.c. § 1396a (2015) (changing the maximum income to 133% fpl); ppaca § 2002(a), 42 u.s.c. § 1396(a)(e) (2015) (standardizing the system of income disregards to include only a 5% disregard). for a single-person household, 138% is $1,354 per month in 2015. for a family of four, it is $2,789 per month. annual update of the hhs poverty guidelines, 80 fed. reg. 3236, 3237 (jan. 22, 2015). 131 brandon & carnes, supra note 67, at xxxiii. see also supra notes 71-75 and accompanying text. 132 nat’l fed’n of indep. bus. v. sebelius, 132 s. ct. 2566 (2012). 133 status of state action on the medicaid expansion decision, kaiser family found., http://kff.org/health-reform/state-indicator/ state-activity-around-expanding-medicaid-under-the-affordable-careact/ [http://perma.cc/7hsk-cuey] (last updated sept. 1, 2015). 134 dan witters, arkansas, kentucky see most improvement in uninsured rates, gallup (feb. 24, 2015), http://www.gallup.com/ poll/181664/arkansas-kentucky-improvement-uninsured-rates.aspx? utm_source=well-being&utm_medium=newsfeed&utm_ campaign=tiles [http://perma.cc/5us7-kpdf]; alexa ura, texas still tops census list of highest uninsured rates, tex. trib. (sept. 16, 2014), http:// www.texastribune.org/2014/09/16/texas-tops-census-list-highestuninsured-rate/ [http://perma.cc/jhp4-t7gp]. 135 see medicaid enrollment by gender, kaiser family found., http://kff.org/medicaid/state-indicator/medicaid-enrollment-by-gender/ http://kff.org/medicaid/state-indicator/medicaid-enrollment-by-gender/ 152 indiana health law review vol. 13:1 in expansion states, the uninsured proportion is dramatically different. combined with the children’s health insurance program, which provides insurance for children through the age of nineteen and some or all services for pregnant women, medicaid enrollment rose by over 26.1% in the first year since the january 1, 2014, effective date of the expansion.136 the national uninsured average has since dropped to 11.9%, a figure that includes the twenty-one nonexpansion states.137 amongst states that have expanded medicaid are massachusetts, which has had the lowest uninsured rate since shortly after the enactment of a state version of ppaca, with an uninsured rate of 4.6%, followed by connecticut and hawaii at 6%.138 thus, medicaid expansion has had a dramatic effect on financial access to care. it has in particular increased access to care for men of modest income. prior to ppaca, the common requirement that an adult be the primary conservator in order to qualify for medicaid was a factor in inflating the proportion of women receiving medicaid, largely because women are more likely than men to be the single parent in possession of a child.139 this is still true in non-expansion states. but, though the data are limited, it appears that in expansion states, men are experiencing a greater increase in access to care through medicaid enrollment. in illinois, for instance, [http://perma.cc/m5zj-n4vu] (last visited nov. 1, 2015) (listing men as 41% of the national population and 43% of texans enrolled in medicaid). 136 ctr. medicare & medicaid serv., dep’t health & hum. serv., medicaid & chip: january 2015 monthly applications, eligibility determinations and enrollment report 3 (2015), available at http:// medicaid.gov/medicaid-chip-program-information/program-information/ downloads/medicaid-and-chip-january-2015-application-eligibility-andenrollment-data.pdf [http://perma.cc/7zvk-62n5]. 137 jenna levy, in u.s., uninsured rate dips to 11.9% in first quarter, gallup (apr. 13, 2015), http://www.gallup.com/poll/182348/ uninsured-rate-dips-first-quarter.aspx [http://perma.cc/b9qt-mzdu]. 138 witters, supra note 134. 139 rachel garfield & anthony damico, the coverage gap: uninsured poor adults in states that do not expand medicaid—an update, kaiser family found. 4 (oct. 2015), http://files.kff.org/ attachment/issue-brief-the-coverage-gap-uninsured-poor-adults-instates-that-do-not-expand-medicaid-an-update [http://perma.cc/7f55xwl9]. 2016 153 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy medicaid enrollees in april 2015 were 55.7% male and only 44.3% female.140 given the removal of the conservatorship and other severely limiting eligibility requirements, which favored women, it is logical that medicaid expansion would cause men to have increased financial access to health care. compounding the problem of coverage in non-expansion states is the system of subsidies and tax credits set out by ppaca for insureds in the him. as described supra, the subsidies and credits available for people between 100% and 138% of the federal poverty guideline are not generous in terms of raw dollar amount relative to the cost of non-group insurance in the him.141 this was not a design flaw, however, as these citizens were intended to be covered by medicaid; the aforementioned national federation of independent businesses ruling interfered with the framework by allowing states to opt out of the expansion, creating a fiscal gap in the availability of healthcare insurance. while the severity of the problem for the four million people who are estimated to be medicaid-eligible should not be minimized, men and women are, on the surface, equally affected, with 49% of those in the coverage gap female and 51% male.142 nonetheless, in non-expansion states, 85% of men who would be eligible for medicaid under the expansion schema fall within the gap while only 78% of women do. 143 thus, this additional barrier to access to health care may be understood as a greater burden for men than women because 140 ill. healthcare & fam. serv., affordable care act enrollment by age, race, and gender as of april 2015 (apr. 2015) (on file with author). 141 see supra notes 71-74 and accompanying text. 142 garfield & damico, supra note 139, at 4. 143 id. wisconsin represents a partial exception, however, because although the state did not expand the medicaid maximum permitted income to 138 percent of the federal poverty guideline, it does provide coverage equally for all adults, regardless of gender, whose income is below the federal poverty guideline. for background, see erin toner, wisconsin chooses its own path to overhaul medicaid, npr (nov. 19, 2013, 2:56 am), http://www.npr.org/blogs/health/2013/11/19/246003602/ wisconsin-chooses-its-own-path-to-overhaul-medicaid [http://perma.cc/ 293u-r6k7]. 154 indiana health law review vol. 13:1 under the current rules in non-expansion states, women are more likely to qualify for medicaid. importantly, the access to care provided by medicaid is “fairly comparable to that of low-income americans with employer-sponsored insurance.”144 it is also significantly better than the access of the uninsured: in the first year of the expansion, hospital uncompensated care costs dropped $7.4 billion dollars, a 21% reduction; medicaid expansion is credited with 68% of that savings.145 in addition, both proportions and volumes of uninsured or self-pay emergency department visits and hospital admissions fell substantially.146 while the importance of the reduced cost to the healthcare system cannot be overstated, on both an individual and population level, utilization cost reduction is indicative of the significance of the increased access to primary care that the medicaid expansion catalyzed. somewhat surprisingly, however, although the medicaid expansion seems thus far to have favored men, as discussed infra, the decrease in uncompensated care suggests that it is women whose access to primary care has been increased. this is because women are as much as 150% more likely than men to have two or more emergency department visits or hospital admissions in any given twelve-month-period.147 144 dep’t health & hum. serv., 2014 annual report on the quality of health care for adults enrolled in medicaid 10 (2014), available at http://www.medicaid.gov/medicaid-chip-programinformation/ by-topics/quality-of-care/downloads/2014-adult-sec-rept.pdf [http://perma.cc/6cg2-uehg]. 145 dep’t health & hum. serv., insurance expansion, hospital uncompensated care, and the affordable care act (2015), available at http://aspe.hhs.gov/health/reports/2015/medicaidexpansion/ ib_uncompensatedcare.pdf [http://perma.cc/8k6v-nppn]. for the full report, which defines “uncompensated care” as the “combined total of bad debt and charity care,” see thomas deleire et al., impact of insurance expansion on hospital uncompensated care costs in 2014, dep’t health & hum. serv. (sept. 24, 2014), http://aspe.hhs.gov/ health/reports/2014/uncompensatedcare/ib_uncompensatedcare.pdf [http://perma.cc/n8e8-mgm8]. 146 insurance expansion, hospital uncompensated care, and the affordable care act, supra note 145, at 1. 147 health, united states, 2014, ctr. disease control & prevention 276 (may 2015), http://www.cdc.gov/nchs/data/hus/ hus14.pdf [http://perma.cc/2zzg-whpw]. http://perma.cc/2zzg-whpw 2016 155 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy that does not, of course, mean that the access to care that medicaid provides is equivalent to that experienced by people in either the group or non-group markets. indeed, federal and state reductions in rates of reimbursement have caused fears that the pool of physicians accepting medicaid would decrease, which is particularly troubling given that an important component of access to care is having a dedicated healthcare provider.148 others have predicted that swelling medicaid rolls would cause the remaining primary care providers to be overwhelmed, decreasing access for all patients as wait-times increased.149 neither concern has borne out, but, were they to, women would likely be disproportionately affected in their access to care, because women are more likely to have a dedicated primary care physician.150 on the other hand, men’s reticence to seek medical care may further exacerbate any provider access issues that may develop.151 in sum, the restrictions on medicaid enrollment in nonexpansion states represent a barrier to care for the significant proportion of the population that is excluded, which predominantly is men, though low-income men in expansion states have a significantly increased financial access to care that puts them on par with similarly situated women. 148 stephen zuckerman, et al., reversing the medicaid fee bump: how much could medicaid physician fees for primary care fall in 2015?, urban institute (dec. 2014), http://www.urban.org/sites/default/ files/alfresco/publication-pdfs/2000025-reversing-the-medicaid-feebump.pdf [http://perma.cc/pzf5-p2c4]. 149 14 million more have coverage, yet doctors aren’t swamped, univ. pittsburg med. ctr. (apr. 29, 2015), http:// www.yourhealthcaresimplified.org/news/14-million-more-have-coverageyet-doctors-arent-swamped-028new/ [http://perma.cc/c8s3-2fp]. 150 chun-ju hsiao et al., supra note 37, at 15. 151 see, e.g., memorandum from stacey zabusky, harris interactive on men’s health study to janelle davis, am. acad. family physicians 3 (may 9, 2007), available at http://www.aafp.org/dam/aafp/ documents/ media_center/men-prevention/final_executive_summary_061307.pdf [http://perma.cc/fcu7-7ryg] (“the majority of u.s. men (92%) indicated they wait at least a few days before seeking medical care or advice, although likelihood to seek care or advice right away increases with age.”). 156 indiana health law review vol. 13:1 4. other third-party payors medicare covers 93% of adults over the age of sixty-five, largely eliminating disparities in access to care by either gender in that population.152 ninety-six percent of medicare beneficiaries, whether male or female, report having a usual source of care from whom they can receive timely medical attention.153 because the program covers two medically needy populations—certain long-term disabled adults along with seniors—regular access to a dedicated healthcare provider is a very important indicator of the efficacy of medicare in creating access to care.154 notably, medicare beneficiaries’ access to care is “comparable to or better than access reported by privately insured individuals.”155 it is also less likely to be financially burdensome.156 fifty-six percent of medicare beneficiaries are female, a disproportion largely due to the longer lifespans enjoyed by women.157 nonetheless, because older women today are less likely to have adequate retirement benefits due to shorter work histories and lower pay,158 they may be more susceptible than men to other income-based limitations on access to care, as noted supra. 152 a profile of older americans: 2012, admin. on aging 14, http://www.aoa.gov/aging_statistics/profile/2012/docs/2012profile.pdf [http://perma.cc/6x37-bu48]. 153 cristina boccuti et al., medicare patients’ access to physicians: a synthesis of the evidence, kaiser family found. 2-3 (dec. 2013), https://kaiserfamilyfoundation.files.wordpress.com/2013/12/8526medicare-patients-access-to-physicians5.pdf [http://perma.cc/v5sf8ash]. 154 id. at 2, 15. 155 adele shartzer et al., access to physicians’ services for medicare beneficiaries 4 (2013), available at http://aspe.hhs.gov/ health/reports/2013/physicianmedicare/ib_physicianmedicare.pdf [http://perma.cc/qx2m-erfj]. 156 the importance of medicare for women 1 (2012), available at http://www.nwlc.org/sites/default/files/pdfs/the_importance_of_medicare _for_women_factsheet_08-29-12.pdf [http://perma.cc/apb2-lumv]. 157 id. see also a profile of older americans: 2012, supra note 152, at 2, 4 (noting that there are 131 older women for every 100 older men, that ratio increase to 203 to 100 at age eighty-five, and that there are four times as many widows as widowers amongst older persons). 158 women and retirement savings, dep’t of labor 2 (aug. 2013), http://www.dol.gov/ebsa/pdf/women.pdf [http://perma.cc/u3ec-4762]. http://www.aoa.gov/aging_statistics/profile/2012/docs/2012profile.pdf https://kaiserfamilyfoundation.files.wordpress.com/2013/12/8526-medicare-patients-access-to-physicians5.pdf https://kaiserfamilyfoundation.files.wordpress.com/2013/12/8526-medicare-patients-access-to-physicians5.pdf http://www.nwlc.org/sites/default/files/pdfs/the_importance_of_medicare_for_women_factsheet_08-29-12.pdf http://www.nwlc.org/sites/default/files/pdfs/the_importance_of_medicare_for_women_factsheet_08-29-12.pdf http://www.dol.gov/ebsa/pdf/women.pdf 2016 157 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy tied to medicare financial access efficiency is the tricare system, which provides healthcare insurance coverage to current and former service members and their families, or roughly 4% of the u.s. population.159 however, because men are much more likely to serve in the military and the women who do serve are typically single,160 women receive dependent coverage in greater proportions. with a divorce rate amongst military families that exceeds the general population161 and very restrictive provisions on post-divorce eligibility for tricare,162 women’s healthcare coverage under tricare is in general more tenuous than men’s. in contrast, men are more likely than women to lose their tricare coverage due to being discharged at less than honorable status, but this occurs in relatively low numbers.163 a recent study made clear that changes to the reimbursement mechanism for civilian providers of health care to tricare beneficiaries, which were unrelated to ppaca but also effective january 1, 2014, did not affect access to care for either gender.164 159 u.s. gov’t accountability office, sole community hospitals: early indications show that tricare’s revised reimbursement rules have not affected access to care (2015), available at http://www.gao.gov/assets/670/669663.pdf [http://perma.cc/g5se-843n]. 160 eileen patten & kim parker, women in the u.s. military: growing share, distinctive profile 4-5 (2011), available at http://www.pewsocialtrends.org/files/2011/12/women-in-the-military.pdf [http://perma.cc/bff2-y895]. 161 jennifer hickes lundquist, a comparison of civilian and enlisted divorce rates during the early all volunteer force era, 35 j. pol. & mil. soc. 199, 213 (2007) (“when compared to same aged, married civilians in the presence of multiple demographic, religious, socioeconomic, and attitudinal controls, enlistees are still more likely to divorce than comparable civilians.”). 162 see 10 u.s.c. § 1072(2)(f)–(i) (delineating the post-divorce tricare eligibility requirements for former spouses, which include twenty years of marriage contemporaneous with as many years of service). 163 see generally evan r. seamone et al., moving upstream: why rehabilitative justice in military discharge proceedings serves a public health interest, 104 am. j. pub. health 1805 (2014) (discussing the nexus between less-than-honorable discharges and access to health care through tricare and the other military health system components, and noting the disproportionate effect on males). 164 gov’t accountability off., supra note 159, at 16. http://dx.doi.org/10.2105/ajph.2014.302117 158 indiana health law review vol. 13:1 in conclusion, given the current restrictions on gender rating by insurance companies, disparities in access to health care vis-à-vis insurance cannot bear attenuated attribution to biophysical distinctions. often, social constructs that tend to influence ability to acquire a health plan are driving this aspect of access to care and generally in favor of men. some of these are also the types of disparities that law is arguably most able to remedy. c. reproductive access to care: the role of competing doctrines this paper began with an example of a proposed legislative restriction on an otherwise lawful medical procedure for women—medication abortion by telemedicine. that bill passed along party lines.165 clearly this represents a gender-specific restriction on access to care, though necessarily along the lines of a biophysical distinction in medical need; but it is problematic and notable because the specific medical service is otherwise a constitutional right, and so a direct proscription would not be lawful. so while idaho became the sixteenth state with a prohibition on obtaining abortion medication through telemedicine, no state disallows the prescription of any other medication via telemedicine.166 relative to the spectrum of medical treatments available by telemedicine, women are disadvantaged by this singular prohibition. somewhat surprisingly, it appears that only one court has attempted to set aside the abortion issue and addressed a similar law from a gender-conscious access-to-care perspective. in planned parenthood of the heartland v. iowa board of medicine, the court acknowledged the potential unequal treatment that inheres in subjecting a single telemedicine procedure to 165 see house bill 154, idaho leg., http://www.legislature.idaho.gov/ legislation/2015/h0154.htm [http://perma.cc/b6zu-frm6] (last visited jan. 5, 2016) (providing the bill’s history to include legislative votes). 166 latoya thomas & gary capistrant, am. telemed. ass’n, state telemedicine gaps analysis: physician practice standards & licensure 81-82 (may 2015), available at http:// www. americantelemed.org/docs/default-source/policy/50-state-telemedicinegaps-analysis-physician-practice-standards-licensure.pdf?sfvrsn=14 [http://perma.cc/7heh-5nuk]. 2016 159 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy stricter regulation than other procedures available by telemedicine.167 but on the matter of the federal and state constitutional equal protection claim, the court essentially held the issue inadequately briefed.168 a further limitation for women on access to this timesensitive need for care is the extension in the idaho law of a civil remedy against the physician to the female patient’s husband, and, in the event of the patient’s demise, her mother.169 given the marginalization of women in some subpopulations, noted infra, this potentially represents a significant mechanism to reduce access to care by women. moreover, the cause of action is not for loss of consortium, or a derivative claim of harm to the fetus (or something equally pious), or even for prescribing abortion medication via telemedicine; but rather the claim is for the knowing or reckless act of performing or attempting to perform an abortion upon a female.170 this override of any consent or stated preference of the female body that received the benefit of a lawful medication, albeit through a newly unlawful method, is yet another way that law can be used to create reduced access for women to care.171 167 planned parenthood of the heartland v. iowa bd. of med., no. cvcv046429, 2014 wl 7054656, at *21 (iowa dist. jan. 7, 2014) (“[the plaintiff] claims that the board's rule has violated equal protection because telemedicine abortion is treated differently than other telemedicine . . . .”) aff’d, 865 n.w.2d 252 (iowa 2015). 168 id. (“[t]he claim is difficult to evaluate because [the plaintiff] has not precisely defined the groups it claims has been treated differently, a must for an equal protection evaluation . . . there is no evidence indicating to what extent the board allows telemedicine in other contexts, so there is no means to evaluate a broad equal protection claim.”). 169 physician physical presence and women protection act, h.b. 154 § 18-618, 63rd leg., reg. sess. (idaho 2015) (enacted), http:// www.legislature.idaho.gov/legislation/2015/h0154.pdf [http://perma.cc/ x4xc-7r53] 170 id. 171 in the context of informed consent laws, women are generally not treated as having full capacity. see deborah l. forman, when “bad” mothers make worse law: a critique of legislative limits on embryo transfer, 14 u. pa. j.l. & soc. change 273, 299 (2014) (citing three primary areas of regulation of informed consent: mental health treatment, medical treatment of minors, and treatment related to women’s reproduction). accord dan l. burk, dna rules: legal and conceptual implications of biological “lock-out” systems, 92 calif. l. http://dx.doi.org/10.2307/3481350 160 indiana health law review vol. 13:1 examples of selective proscriptions on women’s reproductive care services are available elsewhere. such deliberate prohibitions on accessing a particular medical treatment may even occur through mechanisms designed to effect the opposite. for example, within four years of the u.s. supreme court recognizing a right to privacy in all medical care in roe v. wade,172 congress passed the hyde amendment, which prohibits the use of federal public dollars for elective abortion with limited exception.173 a longstanding budget rider, recent efforts to codify the hyde amendment have failed,174 but the amendment itself was reaffirmed in 2010 by an executive order negotiated alongside ppaca.175 expressly prohibited in that order was the use of tax credits and subsidies to pay for healthcare insurance coverage of abortions.176 the hyde amendment represents a significant restriction on financial access to women’s reproductive care because those directly affected include women insured through medicaid, medicare, and tricare, along with all other women whose medical care is provided by or underwritten by the federal government. for this reason, seventeen states use local funds to restore that access, including four that do so voluntarily without judicial intervention.177 the law and rev. 1553, 1580 (2004) (“the historical inclusion of women together with children and mentally handicapped individuals as legal incompetents amply illustrates the danger of judicial preferences not merely to the success of a particular bargain, but to individual autonomy.”). 172 roe v. wade, 93 s.ct. 705 (1972). 173 pub. l. no. 94–439 § 209, 90 stat. 1418, 1434 (1976). 174 e.g., hyde amendment codification act, s. 142, 113th cong. (2013); hyde amendment codification act, s. 1488, 112th cong. (2011). the most recent version, hyde amendment codification act, s. 219, 114th cong. (2015), has been given a 1% chance of being enacted. s. 219: hyde amendment codification act, govtrack.us, https:// www.govtrack.us/congress/bills/114/s219 [https://perma.cc/47nx-tqz5] (last visited may 29, 2015). 175 exec. order no. 13535 ensuring enforcement and implementation of abortion restrictions in the patient protection and affordable care act, 75 fed. reg. 15599 (mar. 29, 2010). 176 id. § 2. 177 guttmacher institute, state policies in brief: state funding of abortion under medicaid, 1 (2015), available at http:// www.guttmacher.org/statecenter/spibs/spib_sfam.pdf [http://perma.cc/ ksb8-guzf]. 2016 161 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy policy in these states stands in stark contrast to the hyde amendment, the constitutionality of which was affirmed in 1980 by the u.s. supreme court.178 holding that there is no right to the use of public funds to provide for any specific medical treatment under the due process or equal protection clauses because the government does not cause the indigency that makes care unaffordable, the court nonetheless noted the role of public policy: “[t]he hyde amendment . . . encourages alternative activity deemed in the public interest.”179 institutional policy may also militate away from access to care in other ways that specifically and derivatively target male and female reproductive medical care. directives by the catholic church turn permissive statutes regarding conscientious objection into mandates for all employees of catholic institutions180 and for catholic providers in secular or other institutions.181 while the majority of these directives are either gender-neutral toward patients—neither men nor women may be rendered sterile in a catholic hospital, for example182—those that preclude medical attention at or before conception, or during pregnancy, do disproportionately limit women’s access to care, and at times where women are most vulnerable. the effect on access to care is multiplied by at least two factors. first, catholic hospitals represent a significant portion of the hospital industry in the united states: every 178 harris v. mcrae, 448 u.s. 297 (1980). 179 id. at 315. while “public interest” does not always equate with the concept of public policy, here it seems it does. 180 see u.s. conference of catholic bishops, ethical and religious directives for catholic health care services, 3 (5th ed. 2009), available at http://www.usccb.org/issues-and-action/human-lifeand-dignity/health-care/upload/ethical-religious-directives-catholichealth-care-services-fifth-edition-2009.pdf [http://perma.cc/xdw7w3q4] [hereinafter catholic directives] (“since they express the church’s moral teaching, these directives also will be helpful to catholic professionals engaged in health care services in other settings.”). 181 see id. at 125 (“catholic health care services must adopt these directives as policy, require adherence to them within the institution as a condition for medical privileges and employment, and provide appropriate instruction regarding the directives for administration, medical and nursing staff, and other personnel.”). 182 id. at 27. 162 indiana health law review vol. 13:1 state has catholic healthcare facilities that provide acute care, skilled nursing, and other services.183 with five states lacking a catholic hospital, one in six patients nationwide nonetheless is admitted to a catholic bed.184 one-third of catholic hospitals are located in rural areas, where they are likely to be the only acute care facility available.185 even in urban areas, accessing a non-catholic institution may be complicated by insurance network rules, poor transportation, inadequate paid time off work, and other socio-economic issues that affect access to care, many of which were explicated above as having a disparate effect on women. the pervasive role of the catholic church in health care means that there are areas of the country where men and women alike are without an alternative choice, in turn rendering their effective access to care of lessened value. second, in addition to federal law, state laws overwhelmingly sanction these access-restricting policies. for instance, every state permits physicians to refuse to provide abortion services, and thirteen states allow providers to refuse to provide contraception.186 additionally, eighteen states have no proscription on providers declining to provide sterilization.187 of course, conscience clauses are not restricted to those providing reproductive care, but because the philosophy became legally recognized post-roe, it has continued to be so associated.188 but by allowing healthcare providers to opt out of providing any health care without regard to the needs of the 183 catholic health ass’n of the u.s., catholic health care in the united states, 2 (jan. 2013), available at https://www.chausa.org/ docs/default-source/general-files/mini_profile-pdf.pdf?sfvrsn=0 [http:// perma.cc/8y4h-3f88]. 184 id. at 1-2. 185 id. at 2. 186 guttmacher institute, state policies in brief: refusing to provide health services, 2 (2015), available at http:// www.guttmacher.org/statecenter/spibs/spib_rphs.pdf. [http://perma.cc/ m3c9-eaw6].. 187 id. 188 the first federal conscience exception to treatment was the church amendment, passed in 1973. 42 u.s.c. § 300a-7(b) (1973). see generally holly fernandez lynch, conflicts of conscience in health care: an institutional compromise, 19-24 (2008) (describing the history of conscience clauses). 2016 163 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy patient, and especially in ways that can disenfranchise entire subpopulations, access to care begins to become meaningless. after all, increasing access to care is futile if no one will provide the care. moreover, given the bend toward declining to provide services that broadly affect women, the directives and supporting legislation reduce access disproportionately. even where the patient is male, restrictions on access to male reproductive care “can only be carried out on the backs of women,” because, ultimately, women are physically, emotionally, legally, and financially responsible for pregnancy or lack thereof.189 ironically, the resultant increased need for care further concentrates the disproportionality of the burden of the lack of access to care for women. religion or other conscientious objection acts as a delimiter on access to reproductive care in other ways, too. as discussed supra, the hobby lobby case provided a potentially broad expansion of religious liberty to for-profit corporations that are closely held.190 unlike the catholic church directives, which proscribe effectively all contraception on the basis of interference with sex as having only “unitive and procreative meaning,”191 the holding in hobby lobby relies not on consistent religious doctrine, but rather a selective and convenient disbelief of science.192 because of the potentially broad applicability of such a holding, it is conceivable that religion may further restrict access to care in the future.193 189 roth, supra note 34, at 393, 411-13. 190 see supra text accompanying notes 113-119. 191 catholic directives, supra note 180, at 24. 192 see sources cited supra note 69. see sources cited supra notes 113119. 193 see hobby lobby, 134 s. ct. at 2787 (ginsburg, j., dissenting) (“in a decision of startling breadth, the court holds that commercial enterprises, including corporations, along with partnerships and sole proprietorships, can opt out of any law (saving only tax laws) they judge incompatible with their sincerely held religious beliefs.”). 164 indiana health law review vol. 13:1 d. transgendering access to care: the role of the nonbinary gender perspective as a final consideration of gender-based health and health care disparities, it is worth a brief foray into the access issues of those whose gender falls outside of the western tradition of a binary gender system. it has been estimated that only 0.3% of american adults are transgender.194 difficulties with defining the transgender population have created challenges in solidifying that number,195 but, nonetheless, it is an increasingly mainstream idea that a not insignificant number of people identify as something other than simply male or female.196 exemplifying both the definitional difficulties and pervasiveness of other-genderedness is recent criticism of facebook: the social networking giant limited its users to one of fifty-eight gender identity options, a number that caused such backlash about its insufficiency that the company felt compelled to make the gender identification option an open question.197 thus, any gender-based discussion should at least consider a selective overview of disparities for those who fall outside of the male/female dichotomy, especially, perhaps, in the context of access to health care, which population health research demonstrates is a considerable source of health 194 gary j. gates, how many people are lesbian, gay, bisexual, and transgender?, 6 the williams institute (april 2011) (estimating the size of the lesbian, gay, bisexual, and transgender population in the u.s. through review of eleven recent surveys regarding sexual orientation or gender identify questions), available at http:// williamsinstitute.law.ucla.edu/wp-content/uploads/gates-how-manypeople-lgbt-apr-2011.pdf [http://perma.cc/4fbz-pcw4]. 195 id. at 2. 196 see, e.g., katy steinmetz, this is what ‘cisgender’ means, time (dec. 23, 2014), http://time.com/3636430/cisgender-definition/ [http:// perma.cc/rv64-hnws] (discussing the usefulness of the newly created term “cisgender,” included in the oxford dictionary only since 2013, to describe those traditionally referred to as “male” or “female”). 197 jessica guynn, facebook's new gender option: fill in the blank, usa today (feb. 26, 2015, 1:00 pm est), http://www.usatoday.com/ story/tech/2015/02/26/facebook-gender-option-fill-in-the-blank/24059551/ [https://perma.cc/9za4-7kmc]. http://time.com/3636430/cisgender-definition/ 2016 165 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy inequality amongst the gender diverse.198 nonetheless, this paper does not seek to fully consider the health concerns of other-gendered persons, not because they are wholly irrelevant, but because they are complex and worthy of fuller treatment than would be appropriate here. additionally, the thesis of this paper is comparative in nature, so the focus here is on a few issues specific to access that mirror the concerns of people gendered as male or female—that is, those who are similarly situated whose access to health care is limited because of, or as a result of, gender. the medical goals of transor other gender persons can create unique issues of access to specialized health care, but access to primary care is often a preliminary barrier.199 as with the reduced access to primary care by women as against men, the reasons are multifactorial. first, the rate of private and employer-based health insurance amongst transgender persons is lower than the national average, as is the mean income.200 as noted supra, health insurance is a proxy for access to health care, and the more modest a person’s income, the less likely that person is to receive preventative care services.201 the concordant issues of enhanced likelihood of health-harming behaviors and difficulty with prioritizing health are also present. second, as much as the marginalization of women in certain communities contributes to lack of primary care, the transgender community is often further on the outskirts of society. as also noted above, marginalization contributes to difficulty accessing care. transgender people may be more likely, however, to experience outright and express 198 frank pega & jaimie f. veale, the case for the world health organization’s commission on social determinants of health to address gender identity, 105(3) am. j. pub. health e58, e59 (2015). 199 michael silverman, issues in access to healthcare by transgender individuals, 30 women's rts. l. rep. 347, 348 (2009). 200 rachel c. kurzweil, note, “justice is what love looks like in public”: how the affordable care act falls short on transgender health care access, 21 wash. & lee j. civil rts. & soc. just. 199, 214-215 (2014). 201 see supra notes 40-42 and accompanying text. http://dx.doi.org/10.2105/ajph.2014.302373 166 indiana health law review vol. 13:1 discrimination from the healthcare community than either women or men.202 third, the mismatch between a transgender person’s appearance and his or her official identification can arouse suspicion, or create inconsistencies that necessitate explanation by the patient and understanding by the healthcare entity representative.203 that is, insurance or other documents may classify a person as one gender, but hormonal or even lifestyle options may mean that a transgender person’s medical needs more closely align with those of the gender opposed to that on the documentation. while that issue is unique to transgender people, it explains why transgender women may be as likely as men to have difficulties accessing preventative health services that are readily available for cisgender women, such as screening for breast cancer.204 this is particularly concerning because hormone therapy may increase the susceptibility to certain conditions, some of which may typically and legally be associated with primarily one gender.205 202 silverman, supra note 199, at 348. this status is reinforced by judicial decisions that hesitate in applying to transgender persons the same intermediate scrutiny as is applicable to sex or gender discrimination against those who fall within the western binary gender perspective. see, e.g., johnston v. univ. of pitt., --f.supp.3d---, no. 3:13–213, 2015 wl 1497753, at *8 (w.d. penn. mar. 31, 2015) (“[n]either the united states supreme court nor the third circuit court of appeals has recognized transgender as a suspect classification under the equal protection clause. accordingly, plaintiff's discrimination claim is reviewed under the rational basis standard. this finding is consistent with numerous other courts that have considered allegations of discrimination by transgender individuals.”) but cf. glenn v. brumby, 663 f.3d 1312, 1317 (11th cir. 2011) (“[d]iscrimination against a transgender individual because of her gender-nonconformity is sex discrimination, whether it's described as being on the basis of sex or gender.”). 203 silverman, supra note 199, at 348. 204 kurzweil, supra note 200, at 208. see also e.g., dani heffernan, colorado trans woman denied free breast cancer screening by staterun program, glaad (oct. 16, 2013), http://www.glaad.org/ blog/colorado-trans-woman-denied-free-breast-cancer-screening-staterun-program. [http://perma.cc/dz3u-2jxp]. see also supra notes 95— 126 and accompanying text. 205 see jamie d. weinand & joshua d. safer, hormone therapy in transgender adults is safe with provider supervision; a review of 2016 167 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy finally, transgender people may receive greater access to care that is specific to the needs of their gender than do women. insofar as gender confirming surgery is a medical need unique to transgender persons, and elective abortion is a medical need unique to women, the increasing availability of the former under medicare and medicaid stands in contrast to the reduced access to care that women experience under the hyde amendment. in these four ways, transgender people are similarly situated to those traditionally gendered yet have reduced access to care by the realities of the operation of law. importantly, for these issues and as a normative matter, transgender persons should benefit from efforts to remedy other gender-based disparities in healthcare access. iii. remediating disparities in access to care through health as a (nonexistent) right the previous section explored the results of various laws and judicial decisions that impact access to health care, noting substantial gender-based disparities result from the agglomerated systems that seek to increase access and instances of judicial unwillingness to give weightier consideration to the access issue. in this section, this paper explains how current efforts to promote equitable access to health care by all genders demonstrate that a public policy of prioritizing health in decision-making by courts and states is appropriate. it does this by first acknowledging that although a constitutional right to health would be a clear mandate that favored health, such a right does not exist in the united states. but by juxtaposing the concept of a right to health with the somewhat disjointed efforts that have been undertaken to increase access to care, it becomes clearer that a judicially cognizable health-favoring policy can be viable. hormone therapy sequelae for transgender individuals, 2 j. clinical & translational endocrinology 55 (2015) (providing an overview of current knowledge in transgender medicine as it relates to the safety of hormone therapy for transgender adults and noting that a severe limitation in the field is the lack of large-cohort studies to study the longterm effects of hormone therapy). http://dx.doi.org/10.1016/j.jcte.2015.02.003 168 indiana health law review vol. 13:1 a. the international formulation of a right to health and access to care if the united states has not comprehensively created a right to health—and perhaps, as explained below, cannot without foundational changes to the healthcare system as it is currently delivered and financed—then we must look to the international community to understand what such a formulation would look like and, moreover, how it defines access to care for similarly situated patients of different genders.206 as a preliminary matter, “the denial of health care has often been understood as essentially interfering with the ‘right to health,’” from an international perspective.”207 this is evident in both the universal declaration on human rights (udhr), which provides the foundation for international human rights,208 and the international covenant on economic, social and cultural rights (icescr), which articulates the most important statement of health as a human right.209 the udhr makes only one reference to health, declaring that “[e]veryone has the right to a standard of living adequate for [] health and well-being . . . including food, clothing, housing and medical care and necessary social services, and the right to security in the event of . . . sickness, [and] 206 see generally eleanor d. kinney, the international human right to health: what does this mean for our nation and world?, 34 ind. l. rev. 1457 (2001) (arguing that international law has concrete implications for domestic policy-making regarding health). 207 report of the special rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, rep. of the special rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, ¶ 11, u.n. doc. a/hrc/22/53, feb. 1, 2013.) (by juan e. méndez) [hereinafter special rapporteur on torture], available at http://www.ohchr.org/documents/hrbodies/hrcouncil/ regularsession/session22/a.hrc.22.53_english.pdf [http://perma.cc/ rk59-yljj]. cf. manjari mahajan, the right to health as the right to treatment: shifting conceptions of public health, 79 soc. res. 819 (december (2012) (arguing that the right to health is unnecessarily indistinguishable from a right to health care in the international community). 208 kinney, supra note 206, at 1459. 209 id. http://dx.doi.org/10.2139/ssrn.296394 2016 169 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy disability . . . .”210 the icescr is similar is in mandating that everyone have “the enjoyment of the highest attainable standard of physical and mental health.”211 the icescr further requires that four steps be taken to achieve “full realization” of the right, including by (1) reducing infant mortality and childhood morbidity; (2) improving living and work environments; (3) addressing all diseases, regardless of etiology; and (4) “assur[ing] to all medical service and medical attention in the event of sickness.”212 as with the udhr, the icescr contains an acknowledgement of the impact of sdoh and couples it with an express statement that access to care is a component of the right to health. complementary for what it contributes to the remediation of gender-based health disparities, the convention on the elimination of all forms of discrimination against women (cedaw) “devotes major attention to a most vital concern of women, namely their reproductive rights.”213 cedaw references access to health care no fewer than six times and particular seeks “a basis of equality of men and women.”214 this goal of equalization is consistent with customary international health law, including as expressed by who. it is also in much the same vein as u.s. federal efforts that seek equity of men and women’s access to health. gender-based disparities in access to health care have begun to inform other forms of international human rights law also. for instance, 2013, the u.n. special rapporteur sought to complement efforts to combat “violence against women by, inter alia, examining gender-specific forms of 210 universal declaration of human rights, g.a. res. 217a (iii), art. 25.1, u.n. doc. a/810 at 71 (1948), available at http://www.un.org/ en/documents/udhr/ [https://perma.cc/c66u-nt5d]. 211 international covenant on economic, social and cultural rights, art. 12, dec. 16, 1966, s. treaty doc. no. 95-19, 6 i.l.m. 360 (1967), 993 u.n.t.s. 3, (1976), available at http://www.ohchr.org/documents/ professionalinterest/cescr.pdf [https://perma.cc/n2pz-kwnr]. 212 id. 213 convention on the elimination of all forms of discrimination against women, dec. 18, 1979, 1249 u.n.t.s. 13, available at http:// www.un.org/womenwatch/daw/cedaw/text/econvention.htm#part1 [https://perma.cc/k3sm-hc7p]. 214 id. at art. 1. 170 indiana health law review vol. 13:1 torture” in the healthcare setting.215 remarkably, on the list of practices found tantamount to torture is the “denial of legally available health services such as abortion and postabortion care.”216 that report also addresses access to care by those who are transgender, most notably around forced medical procedures designed to rectify gender nonconformity; it concludes that section by noting that both formal and informal mechanisms of discrimination by governments and healthcare providers interfere with access to care.217 it is unsurprising that requirements of medically unnecessary surgery that castrate physical functioning would be considered torture, but even describing the inability to access otherwise lawful care as torture is consistent with an international sense of a right to health as a fundamental human right. additionally, the plain language of the conventions noted above demonstrate that the right to health may be understood as consisting predominantly of a right to health care. however, u.s. courts have failed to recognize the international right to health, finding it “insufficiently definite” to constitute a normative rule of law.218 regardless, in order for the international right to health to be adapted to fit u.s. customs, it must be broad enough as to encompass the negative “right to be let alone” that provides the foundation of u.s. jurisprudence underlying roughly half of individual healthcare access cases.219 this is important because were u.s. courts to recognize a broad right 215 spécial rapporteur on torture, supra note 207, ¶ 45. 216 id. ¶ 46. 217 id. ¶¶ 76-79. 218 e.g., sarei v. rio tinto, 650 f.supp.2d 1004 (c.d. cal. 2009) (holding that an assertion to a right to health in an environmental pollution action fails because it is based on a norm that has not achieved the status of a matter of universal concern), vacated on other grounds, 133 s.ct. 1995 (2013). accord flores v. s. peru copper corp., 414 f.3d 233, 254 (2nd cir. 2003) (“as an initial matter, we hold that the asserted ‘right to life’ and ‘right to health’ are insufficiently definite to constitute rules of customary international law.”). see also kinney, supra note 206, at 1471 (noting that implementation and enforcement of the right to health is difficult where it is predicated on customary international law). 219 for a treatise on the two legal mechanisms through which individual access to care is funneled, including public health and privacy, see generally b. jesse hill, the constitutional right to make medical treatment decisions: a tale of two doctrines, 86 tex. l. rev. 277 (2007). 2016 171 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy to health under domestic law, case law suggests that it might be founded on less-than-solid notions of autonomy.220 however, a significant challenge would exist in the united states in adapting a negative privacy-based right to health to make it a positive right to access to health care without a fundamental shift in law and policy. thus this paper next considers the existence of positive rights of access to care in the united states. b. a right to health or health care does not exist in the united states american scholars have for years argued that health is akin to other human rights.221 the concept has even been tied specifically to equalizing disparities in women’s health and health care.222 yet one might note that healthcare “seems to play second fiddle to other civil rights issues.”223 220 id. see also fernandez lynch, supra note 188, at 37-42 (discussing the hypothetical right to care of a patient versus a physician’s right to refuse to provide that care and describing the legal system as, from the patient perspective, a recognition of a “freedom from” rather than a “freedom to”). 221 see, e.g., kinney, supra note 206, at 1471 (“the human right to health is just a moral right after all.”); aart hendriks, the close connection between classical rights and the right to health, with special reference to the right to sexual and reproductive health, 18 med. & l. 225, 226 (1999) (arguing that “[realization] of this right depends necessarily on the protection afforded to certain classical human rights”). but see richard lamm, the case against making healthcare a right, 25 hum. rts. 8, 9 (1998) (“it is problematic to consider healthcare as a ‘right.’ . . . rights are an ineffective way of determining who or what is covered”). cf. emanuel, supra note 12, at 104-107 (arguing that the most efficient distribution of resources would be through a framework for delineating specific medical services—and only those services—as rights). see generally john tobin, the right to health in international law (2012) (providing a historical evaluation of the international right to health and seeking to develop a methodology that is implementable in the united states as with other human rights). 222 see hilary hammell, is the right to health a necessary precondition for gender equality?, 35 n.y.u. rev. l. & soc. change 131, 172 (2011) (“in the absence of a right to health, women in the united states face numerous barriers that prevent them from realizing their highest attainable standard of health.”). 223 silverman, supra note 199, at 347. 172 indiana health law review vol. 13:1 regardless, these discussions largely occurred before ppaca altered the health care schema in the united states, suggesting that revisiting the matter is timely. the timing is important because, as erin c. fuse brown, for example, argues, ppaca can be understood as having created a “new right to health care for the uninsured.”224 fuse brown concluded that the newly established right “will be ephemeral or hollow—a quasi-superstatute rather than a durable superstatute,”225 which is logical if ppaca is viewed as “health insurance reform, not health care reform.”226 but neither formulation, nor the health-as-human-right discourse, addresses population-wide gender-based disparities in access to health care that result from a tradition of minimizing health in law and policy. although this minimization of health may result from a lack of a right to health, in part because such a right is frequently understood as encompassing a right to access needed health care, it is a steadfast status quo. consider fuse brown’s summary of the bleak landscape for the creation of such a doctrine: [t]he u.s. constitution provides neither a textual nor structural basis for such a right. . . . despite the limitations of a conceptual dichotomy between positive rights (e.g., entitlements to social goods) or negative rights (e.g., liberties or freedom from interference), this distinction is a useful description of the federal constitutional posture toward a right to health. . . . nevertheless, the court has not recognized a generally applicable positive right to health care, and it seems unlikely ever to do so.227 224 erin c. fuse brown, developing a durable right to health care, 14 minn. j.l. sci. & tech. 439, 444 (2013). 225 id. at 490. 226 alicia ely yamin, the right to health: assessing how far the discourse has evolved internationally and within the united states, 104 am. soc'y int'l l. proc. 14, 15 (2010). 227 fuse brown, supra note 224, at 455. accord rebecca e. zietlow, democratic constitutionalism and the affordable care act, 72 ohio st. l.j. 1367, 1382 (2011) (“the u.s. constitution does not guarantee a right to health care. the u.s. supreme court rejected such a right, and held expressly that the government has no obligation to pay the medical expenses of indigents.”). http://dx.doi.org/10.5305/procannmeetasil.104.0014 2016 173 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy if this formulation is correct—and this paper assumes it is—then an alternative mechanism must be described if we are to look to law to remedy gender-based disparities in access to care. any such framework need not recreate the wheel, however, and so this paper now turns to the established limited rights to health or health care that promote access in the united states. c. legislated limited rights of access to specific care in the united states statutory rights are those that are grounded not in the constitution, but rather in a statute. similar are durable rights, or those that are accepted as fundamental legal norms but do not necessarily have a constitutional foundation. both are more likely to suffer from ephemerality, as suggested above with regard to ppaca, due to the relative difficulty in entrenching them. in addition, there tend to be a plethora of mechanisms for challenging statutes. still, there are several instances of access to health care that have become nearly as embedded in the cultural expectation as a constitutional right. only two relate to treatment for specific medical conditions for all adults as well as all children: hemodialysis for end-stage renal disease (esrd)228 and palliative care for amyotrophic lateral sclerosis (als), more colloquially known as lou gehrig’s disease.229 both conditions trigger near-automatic coverage that is not by itself gender-dependent, though men are more likely than women to suffer from the two conditions and thus to need the coverage.230 nonetheless, the history of access to 228 social security amendments of 1972, pub. l. no. 92-603, § 299i, 86 stat. 1329, 1463 (codified at 42 u.s.c. § 426-1). 229 consolidated appropriations act of 2001, pub. l. no. 106-554, § 115, 114 stat. 2763, a-474 (codified at 42 u.s.c. § 426(h)). 230 see ctrs. for disease control & prevention, national chronic kidney disease fact sheet, 2014, 1 (2014), available at http://www.cdc.gov/diabetes/pubs/pdf/kidney_factsheet.pdf [http://perma.cc/mx5n-jauk] (“men with [chronic kidney disease] are 50% more likely than women to have kidney failure.”); who gets als?, als ass’n (apr. 2015) (“als is 20% more common in men than in women.”), http://www.alsa.org/about-als/who-gets-als.html/ [http:// perma.cc/4lgm-qnvs]. 174 indiana health law review vol. 13:1 dialysis in particular is instructive in any discussion of the role of law in enabling access to health care and, especially, in the lack of a right to health care.231 as the first effort undertaken by congress designed to increase access to treatment for a particular diagnosis,232 dialysis coverage expressly sought to remedy a disparity in access to care—that is, the lacuna between the wealthy and everyone else.233 yet the design of the coverage in 1972 is one that, then and now, slightly favors men. this is because dialysis treatment is available only to those who are insured by definition of title ii of the social security act, or the dependents thereof.234 as suggested supra, men are likely to achieve title ii-insured status of their own accord because, traditionally, men worked outside the home in greater numbers. however, when combined with the social security administration’s (ssa) treatment of a diagnosis of end-stage renal disease as an automatically disabling condition, coverage becomes effectively universal; medicaid, which defines eligibility in accordance with the ssa, can then cover dialysis where medicare does not even in the absence of the schema of expanded eligibility discussed above.235 but, as was asked by members of the senate finance committee, “[w]hy favor this treatment . . .over the long-term treatment of cancer,” for example?236 because it seems disingenuous to accept that end-stage renal disease represented “the one situation . . . where the only thing separating individuals from life and death was money,” it is 231 e.g., emanuel, supra note 12, at 100-101 (“in the view of many, the development of the dialysis program typifies the more general ‘crisis’ in american medical care.”); richard a. rettig, origins of the medicare kidney disease entitlement: the social security amendments of 1972, in biomedical politics 176, 203 (kathi e. hanna ed.,1991) (“the kidney disease entitlement remains a focus for debate about the relative benefits and burdens of medical technology.”). 232 rettig, supra note 231, at 177. 233 carl w. gottschalk, commentary, in biomedical politics 209, 209-10 (kathi e. hanna ed., 1991). 234 42 u.s.c. § 426-1(a) (2015). 235 soc. security admin., poms di 45001.001, end-stage renal disease (esrd) entitlement provisions (2013) available at http://policy.ssa.gov/poms.nsf/lnx/0445001001/ [http://perma.cc/9yhqf8jv]. 236 rettig, supra note 231, at 191. 2016 175 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy noteworthy that creation of a statutory right in this particular chronic disease was likely more a test of the viability of a national catastrophic health insurance program.237 nonetheless, in the words of one of the original bill’s constructionists, a physician, “[t]he equity issue was agonizing.”238 forty years later, the dialysis coverage debate has not made materialize a system of catastrophic health insurance. another then-senator had predicted why: “[w]e are picking out one particular sector of the whole health care problem, and because it is dramatic, we are trying to push it ahead of everything else. we can only handle so much.”239 insofar as the right to health may be conflated with the right to health care, it is clear the practical limitations of finite social and fiscal resources make impossible a statutory right to medical treatment for all conditions in the same manner that hemodialysis is available for end-stage renal disease. indeed, medicare, which is not the only payer, contributed nearly $29 billion in 2012, or over 5% of its budget, to the care of the 1% of patients with end-stage renal disease.240 dissimilarly, then, are smatterings of other statutory regimes that have in common only a foundational wealthbased inequity that could no longer be stomached. addressed infra were disparities that result from some of these healthrelated schemas, such as coverage by the him, medicaid, and medicare, but others create more specific rights. for instance, the emergency medical treatment and active labor act (emtala) created access to a minimum of stabilizing medical treatment where that treatment mitigates a life-threatening condition, but no more.241 ostensibly grown out of the same concern for unnecessary suffering by the non-wealthy that informed coverage of 237 id. at 191-92. 238 id. at 210. 239 emanuel, supra note 12, at 100 (quoting senator wallace bennett). 240 u.s. renal data system, 2014 annual data report volume 2: end-stage renal disease in the united states 184 (2014), available at http://www.usrds.org/2014/download/v2_esrd_full_14.zip/ [http:// perma.cc/k2qw-mn8j]. 241 42 u.s.c. § 1395dd (2011). 176 indiana health law review vol. 13:1 dialysis, emtala forestalled the somewhat perverse tendency of some physicians to provide emergency care only if payment was guaranteed. because low-income mothers-tobe were a particularly vulnerable population of patients likely to be “dumped,” the act defines active labor as an emergency; the statuses of all other conditions are left to the judgment of the treating provider.242 the legislative determination that imminent childbirth constituted an emergency arguably conflicted with the medical understanding of labor,243 but it is consistent with other disparate legal treatment of pregnancy. furthermore, as noted supra, women are greater users of emergency departments, suggesting that men’s access to emergency care is not equally benefited.244 other areas of law also create specific rights to health and health care. for example, concerns for health have been used to justify entitlements to habitable housing245 and an unpolluted environment.246 occupational regulations limit poor working conditions247 and intolerably low wages248 due, inter alia, to their negative influence on health. public health 242 id. § 1395dd (b). 243 even post-emtala, judicial remedy was necessary to ensure access to emergency care by laboring women. for example, in burditt v. u.s. dep’t of health & human servs., 934 f.2d 1362 (5th cir. 1991), the plaintiff was denied stabilizing care and was instead transferred to a hospital 170 miles away. she gave birth in the ambulance. more recent medicalization of pregnancy might have resulted in different treatment even in the absence of emtala. 244 see supra text accompanying note 109. 245 e.g., conn. gen. stat. ann. § 47a-7(a)(2) (west 2015) (“a landlord shall . . . make all repairs and do whatever is necessary to put and keep the premises in [a] fit and habitable condition.”). 246 e.g., clean water act, pub., l. no. 95-217, 91 state (1977) (codified at 33 u.s.c. § 1251) (“[i]t is the national goal that the discharge of pollutants into the navigable waters be eliminated . . . .”). id. § 1251(a)(1). 247 e.g., occupational safety and health act, pub. l. no. 91-596, § 2, 84 stat. 1590 (1970 (codified at 29 u.s.c. § 651) (the “purpose and policy [is] to assure so far as possible every working man and woman in the nation safe and healthful working conditions . . . .”). 248 e.g., fair labor standards act, 29 u.s.c. § 202 (finding by congress of “the existence . . . of labor conditions detrimental to the maintenance of the minimum standard of living necessary for health . . . .”). 2016 177 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy law even mandates health through provisos requiring inoculation against certain diseases249 and fluoridation of drinking water.250 in all of the above examples, the judiciary has found that the health benefit to the vulnerable masses, without regard for gender, supersedes contrary individual concerns. although the physician may not get paid for the service provided, the emergent patient’s treatment is superior to any takings claim or right to (not) contract.251 the landlord who would decline to maintain his properties, yet finds a willing tenant, loses as against that tenant whose health or physical safety is at risk.252 the corporation that may legitimately need to create and thus dump pollutants to produce a product cannot endanger nearby residents or ecosystems.253 the employer’s financial security is less important than the employee’s physical workspace254 and minimum wages.255 conversely, there exists a right not to contract a communicable disease256 nor to have bad teeth.257 these varied examples show that there is a pervasive tendency in law to value individual access to health and even to health care. such a robust history of health-favoring legislation and supportive judicial decision-making suggests that indeed, we as a nation intend to promote the health of all as a policy goal. 249 e.g., va. code ann. § 32.1-46(e) (west 2014) (requiring mandatory vaccinations “[f]or the purpose of protecting the public health by ensuring that each child receives age-appropriate immunizations . . .”). 250 e.g., colo. rev. stat. ann § 25-215.5-102(1)(i) (west 2013) (“water fluoridation is one of the most researched and cost-effective oral health interventions available . . . .”). 251 burditt v. u.s. dep’t of health & human servs., 934 f.2d 1362, 1376 (5th cir. 1991). 252 kenyon v. regan, 826 p.2d 140, 142 (utah app. 1992). 253 u.s. v. hooker chem. & plastics (the love canal case), 680 f.supp. 546, 556 (w.d.n.y. 1993). 254 miller v. fed. mine safety & health review comm'n, 687 f.2d 194, 195 (1982). 255 w. coast hotel co. v. parrish, 300 u.s. 379, 394 (1937). 256 jacobson v. mass., 197 u.s. 11, 26 (1905). 257 minn. bd. of health v. brainerd, 241 n.w.2d 624 (1976). 178 indiana health law review vol. 13:1 d. the melting pot federal policy on gender-based health disparities similarly suggestive are variations in executive efforts to remedy disparities in access to health care. federally, there are six offices charged with supporting improvements specifically in women’s health. these officers are contained in the national institutes of health (nih), the department of health and human services (hhs), the centers for disease control (cdc), the food and drug administration (fda), the health resources and services administration (hrsa), and the agency for healthcare research and quality (arhq). four of the six offices were established within a four-year period in the early 1990’s.258 despite fifteen years of legislative efforts,259 all but the nih’s office 258 office of research on women’s health, nat’l. inst. of health (dec. 4, 2015) http://orwh.od.nih.gov/about/index.asp [http://perma.cc/ r462-e3ys] (giving 1990 as the date of establishment); vision, mission, history, dep’t of health & human servs. (oct. 7, 2010), http://www.womenshealth.gov/about-us/mission-history-goals/ index.html [http://perma.cc/v7hm-a756] (1991); about cdc office of women’s health, ctrs. for disease control & prevention http://www.cdc.gov/women/about/index.htm [http://perma.cc/c9bzq6fg] (last updated jan. 20, 2015) (established in 1994); about office of women’s health, food & drug admin. (dec. 2, 2014), http:// www.fda.gov/aboutfda/centersoffices/oc/officeofwomenshealth/defa ult.htm [http://perma.cc/37jk-fbsa] (1994). 259 women’s health office act of 1994, h.r. 3874, 103rd cong. (1994); women’s health office act of 1995, h.r. 1736, 104th cong. (1995); women’s health office act of 1995, s. 427, 104th cong. (1995); women’s health office act of 1997, h.r. 920, 105th cong. (1997); women’s health office act of 1997, s. 91, 105th cong. (1997); women’s health office act of 2000, h.r. 4483, 106th cong. (2000); women’s health office act of 2000, s. 2675, 106th cong. (2001); women’s health office act of 2002, h.r. 1784, 107th cong. (2001); women’s health office act of 2002, s. 946, 107th cong. (2001); women’s health office act of 2003, s. 1304, 108th cong. (2005); women’s health office act of 2004, h.r. 4354, 108th cong. (2004); women’s health office act of 2005 h.r. 949, 109th cong. (2005); women’s health office act of 2005 s. 569, 109th cong. (2005); women’s health office act of 2007, h.r. 1072, 110th cong. (2007); women’s health office act of 2007, s. 612, 110th cong. (2007); women’s health office act of 2009, h.r. 3242, 111th cong. (2009) 2016 179 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy of research on women’s health were formally codified with the enactment of ppaca in 2010.260 the focus of each office might be thought of as an express extension to women—and often other demographic groups identified as experiencing significant disparities—of the umbrella agency’s health-related priorities. the nih office seeks to ensure that clinical research includes women and minorities, and that research on women’s health and sex differences is expanded.261 the hhs office on women’s health helps women and girls “achieve the best possible health” through policy, education, and model programs, a three-part mission that reflects hhs’s broader goals as the top department on all matters related to health.262 similarly, the cdc’s office of women’s health focuses on disease prevention and wellness for women and girls.263 in contrast, there is no federal office dedicated solely to men’s health. congress has contemplated mandating such an office thirteen times this century, but these bills have not passed even one house.264 instead, men’s health is treated as a component of women’s health: the cdc website on men’s 260 ppaca § 2509(e) (codified at 42 u.s.c. 299c (2010) (ahrq office of women’s health and gender-based research); ppaca § 2509(f) (codified at 42 u.s.c. § 914 (2010)) (hrsa office of women’s health); ppaca § 2509(g) (codified at 21 u.s.c. 399b (2010) (fda office of women’s health); ppaca § 3509(a) (codified at 42 u.s.c. § 237a) (2010)) (hhs office on women’s health); ppaca § 3509(b) (codified at 42 u.s.c. § 242s (2010)) (cdc office of women’s health). the nih office of research on women’s health was codified in the nih revitalization act of 1993, pub. l. no. 103-43. 261 office of research on women’s health, supra note 258. 262 vision, mission, history, supra note 258. 263 about cdc office of women’s health, supra note 258. 264 men’s health act of 2000, h.r. 4653, 106th cong. (2000); men’s health act of 2000, s. 2925, 106th cong. (2000); men’s health act of 2001, h.r. 632, 107th cong. (2001); men’s health act of 2002, s. 2616, 107th cong. (2002); men’s health act of 2003, h.r. 1734, 108th cong. (2003); men’s health act of 2003, s. 1028, 108th cong. (2003); men’s health act of 2005, h.r. 457, 109th cong. (2005); men’s health act of 2005, s. 228, 109th cong. (2005); men’s health act of 2006, h.r. 5624, 109th cong. (2006); men’s health act of 2007, h.r. 1440, 110th cong. (2007); men’s health act of 2007, s. 640, 110th cong. (2007); office of men’s health act of 2007, h.r. 789, 110th cong. (2007); men and families health care act of 2009, h.r. 2115, 111th cong. (2009). 180 indiana health law review vol. 13:1 health, for instance, cites its office of women’s health as the source of its content.265 the hhs site uses the same header for its men’s health page as for the women’s health page, which, in the span of a few inches, references “women’s health” four times.266 though one might question the equity of this prioritization, at least one court has decided that there is no equality issue presented for want of any injury.267 despite studies suggesting that gender minorities are “disproportionately affected by adverse health outcomes compared to cisgender (i.e., non-gender minority) people,”268 federal policy does not prioritize health issues for those who consider themselves gendered in non-traditional fashion. in fact, of the aforementioned six federal offices dedicated to women’s health, none lists the health of transor othergendered persons as a priority. one other questionable consistency exists: as in the international context, women’s health is often defined in terms of equity with men. such formulation suggests that the collective goal is not truly to see that women achieve the highest state of healthy possible, but merely to no longer allow women to be left behind by the medical arts and sciences. as an equality matter, it is perhaps the best that law can do. however, as a matter of true equity and in accordance with the principles that underlie human rights and even population health, it should be understood as insufficient to seek to merely equalize access to health care. 265 men’s health, ctrs. for disease control & prevention, http://www.cdc.gov/men/ [http://perma.cc/fa6t-kp83] (last updated nov. 4, 2015). 266 men’s health, dep’t of health & human servs. http://www.womenshealth.gov/mens-health/ [http://perma.cc/32vy8a5x] (last updated jan. 10, 2011). 267 baldwin v. sebelius, no. 10cv1033 dms (wmc), 2010 wl 3418436, at *1, *4 (s.d.cal. aug. 27, 2010). 268 sari l. reisner et al., monitoring the health of transgender and other gender minority populations: validity of natal sex and gender identity survey items in a u.s. national cohort of young adults, 14 bmc pub. health 1224, 1224 (2014) (citing eight studies), available at http://www.biomedcentral.com/content/pdf/1471-2458-14-1224.pdf [http://perma.cc/wy9k-29bp]. see also supra text accompanying notes 199-205. http://dx.doi.org/10.1186/1471-2458-14-1224 2016 181 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy iv. shifting public policy in the era of ppaca era and health-in-all-policies a. the judiciary and legislative support for prioritizing health as a public policy there is little doubt that a multitude of reasons can be given as to why we as a nation have not chosen to recognize a constitutional right to health. moreover, there is little likelihood of a move toward recognizing health or health care as a right in the near future. not only does the debate on the insurance reforms in ppaca suggest that health or health care as a right is politically untenable,269 but also the reality of social resources are such that there must be limits to public sponsorship of medical care. therefore, in this subsection this paper explores how emphasizing the equity of access to health care would tend to rectify the disparities. it does this by substituting, in the areas of disparity laid out supra, a public policy that puts a thumb on the scale in favor of health. such a policy contrasts with the current model of balancing that serves merely to reinforce socio-legal gender biases outside of health care. to be clear, the goal is expressly not “cadillac” access to care for all, nor even mere adequate access for every conceivable infirmity. after all, “public policy ought to maximize a nation’s health, not healthcare.”270 instead, then, the proposal is a specific and positive valuation of health that does not unnecessarily catalyze gender-based disparities, as does the status quo. as noted in the first section, this formulation is consistent with the conception of a health-related disparity as unnecessary, avoidable, unfair, and unjust. 269 e.g., michael mcauliff, house passes 56th anti-obamacare measure, huffington post (feb. 4, 2015, 12:59 am), http://www.huffingtonpost.com/2015/02/03/repealobamacare_n_6607080.html [http://perma.cc/8j56-6sm8] (describing the fifty-sixth vote by the house of representatives against all or some of ppaca since 2011). but see erin merson, 3 republicans say no as house again votes obamacare repeal, politico (feb. 3, 2015, 8:09 pm), [http://perma.cc/m94p-3vh6] (noting that the february 2015 vote is the first time any republicans have ever voted against total repeal). 270 lamm, supra note 221, at 10. http://www.huffingtonpost.com/2015/02/03/repeal-obamacare_n_6607080.html http://www.huffingtonpost.com/2015/02/03/repeal-obamacare_n_6607080.html 182 indiana health law review vol. 13:1 politically, such focus is more than tenable for the judicial branch. though the number of people who dislike but are medically buoyed by ppaca is a startling commentary on the contemporary constituency,271 and the judicial branch is less subject to political backlash than the legislature. this is not to suggest that public opinion should influence public policy—in fact, the two are unrelated except insofar as the public votes for its representatives and on state constitutional changes.272 nor is this a call for much-derided “judicial activism,” but rather a shift as a matter of public policy in order to be accordant with the actions of the legislative and executive branches.273 it is a doctrinally sound shift also. although the u.s. supreme court has not iterated a precise definition, “public policy” has been defined in the academic literature as “a policy the objective of which is the common good; it is a policy which its maker believes will serve the people well.”274 it has also been described as “the very essence of law”: 271 for example, polls have shown that while public opinion of ppaca has been middling, americans overwhelmingly support the provisions within it. see patricia zengerle, most americans oppose health law but like provisions, reuters (june 24, 2012, 1:13 am), http://www.reuters.com/article/us-usa-campaign-healthcareidusbre85n01m20120625 [http://perma.cc/k7pj-7t4w] (citing a reuters/ipsos poll); mollyann brodie et al., kaiser health tracking poll: march 2013 (describing monthly public opinion research on opinions of specific provisions and comparing those to poor awareness that ppaca is the source), available at https:// kaiserfamilyfoundation.files.wordpress.com/2013/03/8425-t1.pdf [http:// perma.cc/5wve-q7b2]. similarly telling is the “viral” nature of a story of an opponent of ppaca who soon found himself needing to access care yet was financially unable to do so. see ann doss helms, who should save sight of sc man who can’t afford surgery?, charlotte observer (may 12, 2015 2:00 am), http:// www.charlotteobserver.com/ news/business/health-care/health-care-challenge-blog/ article20696283.html [https://perma.cc/z99q-4nyz]. 272 richard h.w. maloy, public policy—who should make it in america’s oligarchy?, 1998 det. c.l. rev. 1143, 1155 (1998). 273 erich vieth & james p. lemonds, whence public policy? 52 j. mo. b. 239, 243 (1996) (calling judicial legislating “the most serious and recurrent objection to public policy” yet noting that it is “a legitimate tool of [judges’] trade”). 274 maloy, supra note 272, at 1145, 1154. 2016 183 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy the very considerations which judges most rarely mention, and always with an apology, are the secret root from which the law draws all the juices of life. i mean, of course, considerations of what is expedient for the community concerned. every important principle which is developed by litigation is in fact and at bottom the result of more or less definitely understood views of public policy; most generally, to be sure, under our practice and traditions, the unconscious result of instinctive preferences and inarticulate convictions, but nonetheless traceable to views of public policy in the last analysis. 275 because public policy cannot and should not exist in a judicial vacuum, devoid of any explanation for its occasion,276 it is worth noting that specifically in regard to ppaca, the court has noted the individual mandate of healthcare insurance as “congress’s solution to these problems” of financial access to care.277 thus, to weigh the congressional determination that remedying disparities in access to care is a worthy goal would require the courts merely to follow what seems an express greater good in the public’s interest. this is the essence of good public policy. despite the lack of express definition by the court, it has been relatively consistent in assuming that public policy is to be made by the people through the legislature.278 thus insofar as congress has made a clear statement of public policy, the courts should follow suit absent constitutional invalidity.279 given that statutory rights often form the basis of judicial policy concerns, it would be most consistent with the values set forth by congress for jurisprudential policy to 275 vieth & lemonds, supra note 273, at 239 (summarizing and then quoting justice oliver wendell holmes). 276 id. at 245-46. 277 nat’l fed. of indep. bus. v. sebelius, 132 s.ct. 2566, 2585 (2012). 278 maloy, supra note 272, at 1144-45. see also nat’l fed. of indep. bus., 132 s.ct. at 2579 (“[w]e possess neither the expertise nor the prerogative to make policy judgments. those decisions are entrusted to our nation's elected leaders, who can be thrown out of office if the people disagree with them. it is not our job to protect the people from the consequences of their political choices.”). 279 id. at 1168-69. 184 indiana health law review vol. 13:1 more accurately reflect the increased financial access to care established by ppaca.280 also supporting judicial recognition of a public policy shift is the relatively new health-in-all-policies (hiap) approach of population health. “at its core, health in all policies represents an approach to addressing the social determinants of health, which are the key drivers of health outcomes and health inequities.”281 in short, hiap supplements population health by emphasizing the influence on health of policies that are not traditionally associated with public health.282 indeed, “hiap provides a means to identify and avoid the unintended impacts of public policy that can be detrimental to the health of populations or subgroups of the population.”283 an express goal is remedying health inequities.284 because, as delineated above, sdoh also influence access to care, the increasing pervasiveness of hiap should have implications for judicial interpretation also, and particularly as public policy. for example, it is known that “today nearly all aspects of the built environment are shaped by law,”285 suggesting that law has a significant role to play in ensuring that access to care is not defeated by poor civil design. for example, 280 other scholars have also viewed ppaca as changing the public policy of health care in various contexts. see, e.g., fuse brown, supra note 224 (arguing that ppaca created a durable right to health care); karen oehme & nat stern, the case for mandatory training on screening for domestic violence in the wake of the affordable care act, 17 u. pa. j. l. & soc. change 1, 1, 13 (2014) (calling ppaca a “historic opportunity” to address domestic violence as a public health and criminal matter); sara rosenbaum, law and the public’s health, 126 pub. health rep. 130, 130 (2011) (terming ppaca a “watershed” in public health policy), available at http://www.ncbi.nlm.nih.gov/pmc/ articles/ pmc3001814/pdf/phr126000130a.pdf [http://perma.cc/fd9x-sycu]. 281 linda rudolph et al., am. pub. health ass’n, health in all policies: a guide for state and local governments 8 (2013), available at https://www.apha.org/~/media/files/pdf/fact%20sheets/ health_inall_policies_guide_169pages.ashx [https://perma.cc/4bjpfm96]. 282 for various definitions of health in all policies, see id. at 138. 283 who hiap, supra note 30, at 4. 284 id. at 40; rudolph et al., supra note 281, at 8. 285 wendy collins perdue, lesley a. stone & lawrence o. gostin, the built environment and its relationship to the public’s health: the legal framework, 93 am. j. pub. health 1390, 1390 (2003). http://dx.doi.org/10.2105/ajph.93.9.1390 2016 185 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy perdue, stone, and gostin note that urban areas where constituents are unable to advocate politically are the first places that hospitals and other healthcare clinics close.286 not only does such a situation reduce access to those types of medical facilities, but the providers that are left experience greater strain in trying to deliver care, further decreasing access to care.287 by prioritizing health, the physical environment is built in a way that facilitates access to care. the hiap approach would ensure that everyone from city councilmen making zoning determinations to civil engineers designing the city structure would consider the impact on access to care in their decision-making. hiap works as congruently with mitigation of the other sdoh. b. access to care redux so how would health as a public policy priority effect equitable access to care by all people regardless of gender? justice oliver wendell holmes observed that “[t]he very meaning of public policy is the interest of others than the parties and that interest is not to be at the mercy of the defendant alone.”288 presumably the justice would not make it at the mercy of the plaintiff either. through health as a public policy priority, the judiciary might better balance doctrines that interfere with access to care. in the hobby lobby case, instead of truly considering only whether costfree contraceptive coverage by the business’s insurer constituted an undue burden on religion, the court would have to weigh the impact on health and access to care. this analysis would look more like balancing of religious freedom and other governmental initiatives that the court has undertaken. for instance, theoretically applying the same federal statute at issue in hobby lobby, the religious freedom restoration act, to the matter of taxation, the court in hobby lobby maintained that the burden to the tax system would be too great.289 indeed, the majority predicted “chaos.”290 286 id. at 1391. 287 id. 288 beasley v. tex. & pac. ry. co., 191 u.s. 492, 498 (1903). 289 burwell v. hobby lobby stores, inc., 134 s. ct. 2751, 2784 (2014). 290 id. 186 indiana health law review vol. 13:1 although the court does not acknowledge it, there is a great distinction in the value it places on the benefit of taxes to operations government versus the difficulty of excluding religious objectors, and the benefit of access to prophylactic care to female employees versus the difficulty of excluding the objectors. that is, the “fundamental point” of whether there is a “less restrictive alternative”291 obscures the counter-claims and renders them of no import. the dissent likens the inadequate weight given by the court to the access to care claims to a right to swing one’s arms, which, as the apologue goes, ends where another’s nose begins.292 thus, by applying to health those same concerns of the impracticality of a two-tiered system of taxes, the court would have to weigh the impairment on access to care presented by the arguments of hobby lobby. rather than dismissively stating that female employees still have access because the general public can absorb their cost-share,293 as the majority did, the court would balance, as suggested by the dissent, that there is significant impact on access to care.294 this is particularly true where precedent may allow a future court to further diminish the importance of the health populace where, for instance, the effect is somewhat more than the “precisely zero” amount that the hobby lobby court found.295 although having a direct impact on the access to care by women, as it was at issue in the case, this suggested collectivist public policy understanding of health would improve access to care by men and women both and on an individual and population level.296 accordant is king and associated cases, wherein the plaintiffs contended that tax credits and subsidies should not be available in exchanges set up by or in partnership with the federal government. those courts would be free to disregard the petitioner’s claims based not only on legislative history, 291 id. 292 id. at 2791 (ginsburg, j., dissenting). 293 id. at 2760. 294 id. 295 id. at 2760. 296 see mahajan, supra note 207, at 834 (“a renewed focus on the collectivity in public health might lead to more sustainable and equitable arrangements that appreciate state's responsibilities to the larger public good, which are indispensable to ensuring health to the individual.”). 2016 187 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy which they collectively found unhelpful,297 but also on the presumption that congress intended to increase access to care nationwide and not at the whim of ideologically opposed state governors.298 given the attempts to wholesale modify the entire private healthcare insurance market, it is an assumption grounded in logic that efficacious change could not be accomplished by increasing insurance availability for only select citizens.299 it is also an assumption grounded in a health-prioritizing perspective. that the kings may thusly genuinely suffer harm because of this proposed public policy is consistent with public health law at large because that doctrine values health—and access to health care—over individual objection. in some ways the circuit courts in these cases recognized such a value. both the pruitt and halbig courts supposed that they were “ensuring that policy is made by elected, politically accountable representatives, not by appointed lifetenured judges” by holding in favor of the plaintiffs.300 though implicitly tautological in nature due to the courts’ notice of both the “high stakes”301 of the case and ppaca’s “lofty goals”302 while holding in contrary fashion to both, the recognition of the importance of public policy in these decisions suggests that there may be a judicial want for a mechanism for favoring health. the court in halbig noted, 297 compare halbig, 758 f.3d at 407-12 (“[t]he legislative record provides little indication one way or the other of congressional intent”), and king, 759 f.3d at 372 (“[n]othing in the legislative history of the act provides compelling support for either side's position”), with pruitt, 758 f.3d at 1088 nn.15-16 (describing why it found the legislative history irrelevant). 298 the fourth circuit effectively came to this conclusion, catalyzing the king petition for certiorari, when it held that chevron deference meant accepting the plausible determinations of the internal revenue service. see king, 759 f.3d at 368-69. 299 see, e.g., halbig, 758 f.3d at 406 n.10 (discussing increased access under ppaca of the children’s health insurance program, which uses the same language at issue in the case before the court, and observing that “we recognize the oddity of requiring some states and not others to take this step . . .”). 300 pruitt, 51 f.supp.3d at 1092; halbig, 758 f.3d at 412. 301 pruitt at 1091. 302 halbig, 758 f.3d at 412. 188 indiana health law review vol. 13:1 for instance, that it “reach[ed] [its] conclusion, frankly, with reluctance.”303 that reluctance was shared by the supreme court, but only because it found the text ambiguous and thus sought to “produce[] a substantive effect that is compatible with the rest of the law.”304 although the court subscribed to the belief that “congress passed the affordable care act to improve health insurance markets, not to destroy them[,]”305 it does not expressly consider that the health of the populace, insofar as access to care is a determinant of health, should be a sufficient catalyst in holding against the plaintiffs. it seems, then, that there is a trend of courts unwilling to protect access to care by individuals—and often along gender lines—unless there exists an economic harm to the masses. such harm, of course, would belie the definition of health and misunderstand access to health care. thus because “the very process of litigation around socioeconomic rights tends to produce a relative sidelining of the public good,”306 and because, as described above, there is no right to health, there should be broad judicial notice that the discrete issues highlighted by ppaca-related lawsuits are not necessarily actions designed to benefit the masses, though the petitioners may so believe. but “[j]udges must be careful that, by the use of objectivist abstractions, they don't overly distance themselves from the human beings their decisions will effect [sic].”307 if the courts will not concern themselves with access to care by the population at large, who will? one need only consider the baldwin case mentioned supra to find an example of the clear inequity that results from failure to appreciate the value of health and health care amidst other doctrinal concerns. in that case, the court found that the temporal and financial resources provided to women’s health did not create inequality for men, but not as a matter of health and certainly not in terms of the gender 303 id. 304 king v. burwell, 135 s.ct. 2480, 2484 (2015) (quoting united sav. ass’n of tex. v. timbers of inwood forest assocs., 484 u.s. 365, 371 (1988)). 305 id. at 2496. 306 mahajan, supra note 207, at 829. 307 vieth & lemonds, supra note 273, at 246. 2016 189 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy health disparity that was alleged.308 rather, the court responded to the plaintiff’s claimed harm dismissively with only a conclusory statement that there was insufficient demonstration of any injury.309 by putting baldwin’s claim in the context in which it was made—that is, relative to the ppaca provisions that finally codified multiple offices of women’s health, all of which expressly seek to improve various forms of access to care by women—one must consider that perhaps men’s health is undervalued in this law and policy. through a public policy lens that emphasizes health, this is clearly a gender-based disparity that is unnecessary, avoidable, unfair, and unjust. after all, the offices were created and funded because research will follow dollars, suggesting that there may be decreased economic incentive to prioritize men’s health. and though congress and the agencies themselves must—and should—mean to improve women’s health, they surely do not intend to do so at the expense of men. disparity cannot be remedied through complete diversion; rather, it is through the affirmative act of prioritizing parity that inequality is resolved. yet health as a public policy priority does not require that access always and necessarily be favored. in national federation of independent businesses, for example, which challenged, inter alia, the mandatory medicaid expansion, nullification might still have resulted. after all, the court’s opinion effectively rested on antifederalist public policy that precludes the coercion of the states by the federal government.310 because the states’ entire pool of medicaid dollars were at risk,311 finding the expansion unduly coercive was likely. nonetheless, through increased prioritization of health the court at least would have had additional support in noting the legislative goals in mandating—and providing 308 baldwin v. sebelius, no. 10cv1033 dms (wmc), 2010 wl 3418436, at *4 (s.d.cal. aug. 27, 2010). 309 id. 310 nat’l fed. of indep. bus. v. sebelius, 132 s.ct. 2566, 2601-07 (2012) (“[t]he financial ‘inducement’ congress has chosen is much more than ‘relatively mild encouragement’—it is a gun to the head.”). id. at 2604. 311 id. 190 indiana health law review vol. 13:1 long-term funding for—the expansion. consider the plethora of instances of ppaca that assume the medicaid expansion, including the nonexistence of credits and subsides for those under 100% fpl and the relatively low value of the financial assistance for those covered under the expansion. had congress not contemplated a blanket increase in access to care for the indigent, particularly as opposed to the option to forego insurance and pay a penalty for those of less modest income, the body would not have created the dual tiers. the court also could then have considered the impact of no expansion on the healthcare system at large. because uncompensated care costs average $50 billion per year nationally, it would not correct the issue of access to care if whole states were left without coverage for their poor.312 compounding the effect is that, as explicated above, the poor are more likely to lack both employment-based and private insurance, and they are also more likely to be medically indigent, suffering greater mortality and morbidity than do those with higher incomes. so while the medicaid expansion may have still been deemed too coercive to withstand constitutional muster, under the public policy prioritization of health and access to care proposed herein, the court may have at least considered the effect on health and access to care of making optional the expansion. greater gender parity in access to care would result because the medicaid expansion gave to indigent, childless men an option for coverage that does not otherwise exist. traditionally, however, although private healthcare insurance is broadly obtained in similar numbers by men and women, but in lesser numbers by the transgender, men have had the greatest independent insurance coverage. this disparity is due to a recent national history that ties healthcare insurance to employment during working years, along with the subsequent availability of medicare in retirement only for those with a sufficient pattern of work. as noted above, healthcare insurance coverage and financial barriers are widely accepted measures of access to health care. to the extent that ppaca sought to remedy disparities in financial access to care, a public policy favoring health would 312 deleire et al., supra note 145, at 3. 2016 191 “unnecessary, avoidable, unfair, and unjust”: [en]gendered access to care in the ppaca era and the case for a new public policy tend to make enforcement of individual provisions easier, in part by facilitating a joint effort. for instance, the failure of insurers to implement ppaca cost-share preventive provisions implicates state governments, who are tasked with enforcing insurance laws. while legal education of citizens on rights to challenge insurance coverage denials would surely decrease the number of abuses, state department of insurance regulators are well-positioned to create systemic changes by prioritizing the issue. although law already encourages this enforcement, the federal government could reinforce its commitment and its law through limited grants that might be made available to entice states to prioritize this issue.313 with regard to state legislatures, at a minimum and as a matter of federalism, they may not conflict with federal precedent once a public policy on a matter has been established.314 examples of the efficacy of health and access to care as a public policy priority might be found in the illinois legislature’s current attempt to create a more patient and health-friendly balance between the genuine religious objections of catholic providers and the patients who rely on them for health care.315 that bill would require that healthcare providers inform patients of their options rather than merely refusing to provide the requested care, in the process under-informing the patient.316 the text of the bill contains an express statement of impetus: it is “the public policy of the state of illinois to ensure that patients receive timely access to information and medically appropriate care.”317 disallowing further expansion of conscience clauses as a matter of public policy increases access to care across the board, particularly for those in rural areas, and especially for women to the extent that their access is disproportionately 313 see oehme & stern, supra note 280, at 17-20 (discussing ppaca as creating an “opportunity for cooperative federalism”). 314 see maloy, supra note 272, at 1169 (noting that courts may “strike down a state’s public policy [if] there is a conflict with federal public policy”). 315 health care right of conscience act, s.b. 1564, 99th leg., reg. sess. (ill. 2015). 316 id. § 6.1. 317 id. § 2. 192 indiana health law review vol. 13:1 affected by a refusal to provide medical treatment or prescriptions drugs. v. conclusion it has been observed that as a nation we “limit healthcare in one of the cruelest ways that any nation can do so–by simply leaving people out of the system.”318 although limitations in access to health care may be inevitable, it should be unacceptable that law and policy have embedded gender-based disparities into the access equation. these gender-based disparities exist through codified schema generally designed to facilitate access to care, both as an accidental and deliberate by-product of philosophies and doctrines that are granted greater importance than access to care. with regard to the failure of law to increase access to care, remediable areas include those that create disparities in access through a deprioritization of health. making health a public policy priority is appropriate given that ppaca changed the healthcare landscape; this paper is not the first to suggest that we are now in an era of even more deliberate efforts to erase disparities in access to care. the judiciary and states should follow suit and recognize the emphasis that the other federal branches have placed on health in order to avoid disparities that are unnecessary, avoidable, unfair, and unjust. 318 lamm, supra note 221, at 9. public health surveillance in the context of covid-19 jennifer oliva partial transcript of virtual grand rounds summer series lecture* july 31, 2020 professor oliva: thank you so much professor terry for having me today, and a huge thanks to director brittany kelly for organizing such a fabulous program. it is a privilege to be here. professor terry, thank you as well for showcasing junior scholars and giving us so many opportunities throughout the year to present our work. i am well aware that it is friday afternoon and i am going to do my very best today to try to make this entertaining. i really look forward to your questions at the end of the presentation because that is when i always learn something new. today, we are talking about public health surveillance in the context of covid-19. my presentation will focus on contact tracing, so let me give you a roadmap for today’s discussion. i am going to start out by providing some background on traditional contact tracing, including its genesis, efficacy, and benefits. i will also highlight some of the significant challenges with contact tracing and disease surveillance with a focus on covid-19 and the current state of track-and-trace in the united states. i will then explain the various digital track and trace technologies that have been developed or are under development to supplement traditional contact tracing to make the process more effective. i will also point out the strengths and weaknesses that attend to the current technologies that are available in the united states and abroad. i will then provide a survey of health data privacy laws. one of the themes that i want to emphasize today is that we do not have a federal-level general data protection law in the united states. therefore, once we start talking about the collection of sensitive health care data outside the traditional health care system, we start to run into huge gaps in the law. i will touch on the california consumer privacy act as well as the recent bills that have been introduced in congress to protect health data captured by contact tracing applications. i will also give an overview of one of the most misunderstood laws in the united states—the health insurance portability and accountability act of 1996 (“hipaa”). i will conclude by discussing the legal recommendations from my recent book chapter, which i derived from the work of a number of scholars who have closely examined the benefits and weaknesses of digital track and trace * indiana health law review and the william s. and christine s. hall center for law and health at the indiana university robert h. mckinney school of law give special thanks to professor jennifer oliva for participating in the virtual grand rounds summer series and providing her perspective on public health surveillance. professor oliva is an associate professor of law at seton hall law. 108 indiana health law review [vol. 18:107 technology.1 these scholars include bioethicists, computer scientists, digital technology experts, epidemiologists, as well as health law and privacy scholars. these recommendations envision the implementation of a comprehensive and successful digital contact tracing strategy throughout the united states. after reviewing the recommendations, i look forward to taking your questions. so, let’s get started. we are going to talk about traditional contact tracing first. the gentlemen here on my first slide is the plague doctor, who treated individuals suffering widespread medieval european epidemics. scholars trace the advent of plaguedoctoring to the mid-seventeenth century western europe bubonic plague outbreak. you can see the plague doctor is donning a quite unique outfit, the concept of which is credited to french royal physician charles de lorme. the most famous aspect of the plague doctor’s costume is the beak-shaped mask. at the time, the dominant theory was that contagions were spread by miasmas—or poisoned air that emanated from organic material such as rotting things or dead bodies. the “bad air” would create an imbalance in a victim’s “humors” or bodily fluids and cause the victim to become infected with the plague and fall ill. the purpose of the beak was to protect the plague doctor from these poisonous miasmas. the beak masks that were worn at the time were about six inches long and stuffed with aromatics, such as nosegays, cloves, mint, theriac, and other protective herbs. in short, the beak mask would protect the plague doctor from inhaling pestilential miasma. the second interesting aspect of the plague doctor’s costume is the stake or cane. the stake—which was approximately six feet in length—served as an early social distancing tool, which the doctor used to ensure they stayed far enough away from contagious persons. miasma theory, of course, has been entirely debunked by germ theory, and we now know that the bubonic plague was caused by yersinia pestis bacteria. the stake, however, is an important symbol in the context of covid-19 surveillance because we generally view “contacts” as individuals who have been within six feet of an infected individual for approximately fifteen minutes. contact tracing is a time-tested public health invention intended to identify and stem the spread of contagious diseases. it is a three-step resource-intensive process. the initial step is for public health workers to accurately identify an infected individual, which is called a “case.” the public health workforce then reaches out to that infected individual and interviews them to identify their “contacts”—that is, the people that the interviewee has been in contact with who are at risk of disease exposure. modern day case interviews are extensive. just today, the new york times published an article called “contact tracing is failing in many states: here’s 1. jennifer d. oliva, surveillance, privacy, and app tracking, in assessing legal responses to covid-19 40 (scott burris et al. eds., 2020), https://static1.squarespace.com/static/ 5956e16e6b8f5b8c45f1c216/t/5f4d6578225705285562d0f0/1598908033901/covid19policypl aybook_aug2020+full.pdf [https://perma.cc/h8fe-j3nj]. 2021] public health surveillance in the context of covid-19 109 why.”2 among the things the article discusses is the number of questions that contact tracers ask interviewees during contact tracing phone interviews, which can include up to thirty questions. the article points out that contact tracing interviews are often invasive. some public health departments, for example, begin their interview with an infected individual by asking them where they woke up on the morning of the call or who they slept with the night before. contact tracers also need to ascertain the identity and contact information of every person that the infected individual has had potentially transmissible contact with over the prior fourteen-day period. these interviews, therefore, are time-consuming and seek very detailed, personal information. as a result, it is critical that the contact tracer is trained to build rapport and trust with case interviewees. last but not least, the contact tracer is required to reach out to interviewee’s contacts and (1) inform them that they have been exposed to covid-19; (2) encourage them to get tested and give them information about how to assist with that process; and (3) ask them to quarantine and isolate themselves. the process is iterative and goes on and on from there. the johns hopkins center for health security, the association of state and territorial health officials (“astho”), and the centers for disease control and prevention (“cdc”) estimate that the united states needs approximately 100,000 trained contact tracers in order to effectively implement conventional covid-19 contact tracing.3 a national public radio survey of united states public health departments published in late june 2020 found that our contact tracing workforce is at only about 37,000 strong.4 in other words, we currently do not have even half of the public health workforce in place that we need to conduct effective contact tracing. i do not point this out to criticize already over-taxed local public health departments. it is difficult and time-consuming to train people to become effective contact tracers in the middle of a surging pandemic driven by a disease that does a lot of its work through asymptomatic transmission. 2. jennifer steinhauer & abby goodnough, contact tracing is failing in many states. here’s why, n.y. times (july 31, 2020), https://www.nytimes.com/2020/07/31/health/covidcontact-tracing-tests.html [https://perma.cc/dkz5-lysu]. 3. michael fraser et al., ass’n of state & territorial health officials, a coordinated, national approach to scaling public health capacity for contact tracing and disease control 4 (2020), https://www.astho.org/covid-19/a-nationalapproach-for-contact-tracing/ [https://perma.cc/9hkr-3vgc]; tanya albery henry, experts: here’s how many more contact tracers u.s. needs, ama (july 30, 2020), https://www.amaassn.org/delivering-care/public-health/experts-here-s-how-many-more-contact-tracers-us-needs [https://perma.cc/zc76-c43r]. 4. selena simmons-duffin, as states reopen, do they have the workforce they need to stop coronavirus outbreaks, npr (june 18, 2020), https://www.npr.org/sections/healthshots/2020/06/18/879787448/as-states-reopen-do-they-have-the-workforce-they-need-to-stopcoronavirus-outbre [https://perma.cc/g3py-xe5x]. 110 indiana health law review [vol. 18:107 new york city has long had a fifty-person contact tracing team.5 in response to covid-19, however, the city ramped up its new “test and trace corps” from fifty to 3,000 tracers in two weeks at the beginning of june 2020. as the media has detailed, this rapid attempt to bolster the force has been challenging and riddled with problems. the city’s forty-five minute, sixteen-step questionnaire, which begins with questions about race and sexual orientation and fails to even broach inquiries about the interviewee’s contact until step eleven, is particularly concerning. the benefits of traditional contact tracing are well-documented in the public health literature. contact tracing has proven effective at detecting and mitigating the spread of contagious diseases. also, when contact tracers do build a rapport with their interviewees, they can assist infected individuals to obtain social services and other resources that facilitate health-enhancing behaviors and make it easier to isolate or quarantine for up to two weeks. massachusetts has been lauded for its contact tracing program because the commonwealth’s contact tracers start their interviews by asking interviewees whether they need assistance, such as help procuring groceries or medications, to facilitate quarantine and isolation. it appears that several of massachusetts’ 351 public health departments have adopted this approach and have been successful at building rapport and trust quickly with interviewees by offering help at the front end of the interview. traditional contact tracing can promote economic recovery, and thereby reduce widespread economic anxiety and suffering. it can also facilitate the protection of vulnerable populations that are at a higher risk of contracting covid-19 and more likely to experience an adverse health outcome attributable to infection or—worse—succumb to the disease. contact tracing, of course, has its detractors. it has been characterized as slow, passive, and riddled with holes. this is because contact tracing relies on two very important things: honesty and human memory. as already mentioned, contact tracers attempt to get interviewees to cooperate and honestly respond to very personal questions, such as who the interviewee had intimate contact with over a two-week period. moreover, even assuming the interviewee trusts the tracer and desires to communicate personal information honestly, the interviewee is nonetheless limited by the constraints of human memory. with covid-19, which spreads from infected but often asymptomatic persons to others, it is very difficult for human beings to remember everyone they have had contact with or stood within six feet of for ten to fifteen minutes over a fourteen-day period. to try to mitigate such memory limitations, traditional contact tracers often ask interviewees to reference their phones and calendars to refresh their recollection. needless to say, traditional contact tracing is a time-intensive and imperfect process beset by the fallibility of human memory. a recent covid-19 spreading event in my home state of new jersey helps 5. sharon otterman, city praises contact-tracing program. workers call rollout a ‘disaster,’ n.y. times (july 29, 2020), https://www.nytimes.com/2020/07/29/nyregion/new-yorkcontact-tracing.html [https://perma.cc/8969-gwze]. 2021] public health surveillance in the context of covid-19 111 us put the challenges that attend to traditional contact tracing in perspective. on july 11, 2020, approximately 100 teenagers between the ages of fifteen to nineteen attended a large house party in middletown, new jersey, which is in monmouth country where the governor of new jersey lives.6 shortly thereafter, more than twenty of those teenagers tested positive for covid-19 and the middletown health department quickly realized that it had to attempt to contain community transmission of the virus. in an attempt to do so, the middletown health department began to reach out to the teenagers who had attended the party as well as their parents. the contact tracers, however, met widespread resistance. many of the parents and teenagers refused to take the health department’s calls or answer any questions. this demonstrates the challenges that public health departments and their contact tracers face in the context of a problematic spreading event. the middletown teenagers did not want to tell their parents that they had been at an indoor party in the middle of the pandemic where they may or may not have been drinking alcohol or taking part in other activities. and, their parents did not want the teenagers targeted or investigated by the township, county, or state. i looked at the status of this cluster this morning and there are now more than fifty teenagers who have tested positive for covid-19 linked to that single july 11 house party.7 while trust in the public health system is a considerable problem, the biggest obstacle to effective contact tracing is the country’s lack of accurate, widespread, and timely covid-19 testing. as things currently stand in the united states, state and local government entities are responsible for testing and contact tracing. there remain far too few tests and the lag between tests and the issuance of test results remains too wide. in numerous states, symptomatic individuals have to wait up to seven to nine days to get their covid-19 test results. i cannot emphasize enough that it is near-impossible to control or mitigate a contagion that spreads through asymptomatic transmission for days without timely and accurate testing. the current state of covid-19 testing undermines the hope that contact tracing can succeed. i am not an infectious disease expert by any stretch of the imagination. in fact, pre-covid-19, i limited my examination of the law and policy that attend to contagious diseases and infectious diseases that are co-morbid with substance use disorder. those diseases, like syphilis or human immunodeficiency virus (“hiv”), are easier to track and trace because they do not spread from person to person silently through the air. covid-19 transmission is an entirely different situation. the fact that we do not have robust testing in the united states is the 6. jorge fitz-gibbon, covid-19 cluster linked to nj house party, parents not cooperating with tracers, n.y. post (july 23, 2020), https://nypost.com/2020/07/23/nj-partyleads-to-coronavirus-cluster-parents-wont-cooperate/ [https://perma.cc/9sc8-6cgn]. 7. carly baldwin, 65 new covid cases in middletown, nearly all in teens 15-19, patch (july 27, 2020), https://patch.com/new-jersey/middletown-nj/65-new-covid-cases-middletownnearly-all-teens-15-19 [https://perma.cc/8t3g-yb4q]. 112 indiana health law review [vol. 18:107 achilles heel for traditional contact tracing, and it is not a problem that can be remedied by digital applications. a popular media narrative that emerged this spring is the notion that digital contact tracing would save us from the shortcomings of traditional contact tracing. as the story goes, digital contact tracing will be particularly useful in the context of covid-19 because it does not depend on human memory or honesty. instead, it uses surveillance technology to pinpoint “contacts.” digital track-andtrace, therefore, will provide the public health workforce with more detailed and precise information about potential asymptomatic transmission and do so more quickly. media accounts circa march and april of 2020 made it seem inevitable that the united states would adopt widespread digital contact tracing. american technology behemoths, google and apple, announced that they were joining forces to develop exposure notification digital application programming interfaces (“apis”) that work on both android and mac os smartphones. these applications use smartphone short-range bluetooth signals to anonymously keep track of phone proximity and then send alerts to users who have potentially been exposed to someone who has tested positive for covid-19. is this technology an improvement on traditional contact tracing? the general consensus is a resounding yes. digital contact tracing is more comprehensive than traditional tracing because it tracks proximity between application users at all times so long as those users have their phones on and have enabled the application. assume you keep your phone or your digital device on your person at all times and have downloaded a digital tracking application. you no longer need to be honest with contact tracers and divulge sensitive information to strangers. you also do not need to have an infallible memory. digital contact tracing is much cheaper and faster than traditional tracing because it avoids the need to conduct time-intensive interviews and build rapport with skeptical interviewees. as a result, digital contact tracing has been heralded as a huge improvement in the traditional process. digital contact tracing, however, also suffers serious flaws. first, and as already mentioned, digital track and trace technology cannot function effectively without widespread and accurate testing in place. traditional contact tracing must discern when someone is infected in a timely manner in order to mitigate spread. digital tracing applications must be able to do the same. this is because tracing applications do not send notifications to contacts unless and until there is some indication that an application user is positive. given the asymptomatic contagious period that attends to covid-19, our lack of widespread, timely testing undermines both traditional and digital contact tracing. second, and unlike traditional contact tracing, individuals who either do not have access to a smartphone or lack a data plan needed to support track and trace applications are excluded from digital contact tracing. moreover, the google and apple apis rely on bluetooth technology that is only available on newer devices. it is possible, therefore, that even someone like my mother—who has a very old smartphone and refuses to get a new one—would be excluded from using the google and apple digital tracing applications. as a result, digital contact tracing can supplement—but not entirely supplant—traditional contact tracing. some 2021] public health surveillance in the context of covid-19 113 people simply do not have access to the necessary technology or the technical expertise to participate in traditional tracing, while others may prefer to talk to a human being with whom they can build rapport and trust. third, although digital contact tracing requires less individual cooperation than traditional tracing, it still requires some cooperation. let us revisit the earlier example with the new jersey teenagers. the individuals who attended the party could have eluded digital contact tracing just as effectively as they dodged the middletown health authorities by simply disabling the tracing applications on their phones during the house party or leaving their phones in their cars. so, there are limits to digital tracing in particular situations involving even savvy smartphone users who have the latest technology and who want to avoid detection or surveillance. digital contact tracing also raises heightened privacy and civil liberties concerns relative to traditional contact tracing. traditional tracing is very invasive. traditional contact tracers ask a myriad of questions about individual conduct and associations that interviewees may not want to answer and that implicate others. that, however, pales in comparison to digital contact tracing, which either tracks users’ movements or their proximity to others 24/7. there are two primary types of digital contact tracing applications, one of which is preferred to the other on privacy and efficacy grounds. the first type of digital contact tracing relies on “location applications.” these apps use global positioning service technology or cell site location information to pinpoint the application user’s location on planet earth. location applications track your geolocation when you go into a store to shop, walk-in or out of your home, or drive on the garden state parkway. the second type of digital contact tracing is driven by proximity technology. these applications do not track the user’s geolocation or whereabouts on planet earth. instead, they use bluetooth low energy signals to track the distance between the user’s digital device—such as their phone or tablet—and other users’ digital devices, as well as the time that elapses once two users’ devices, are proximate to one another for a period of time that might trigger exposure. there are significant differences between location and proximity applications. location application data uses global positioning service (“gps”) and cell site location information (“csli”) technology. csli consists of pings that our smartphones are constantly making to cellular towers to give us cell phone access. location applications, therefore, collect a lot of personal data about their users’ whereabouts or movements. they are nonetheless disfavored vis-à-vis proximity applications. this is because csli often is not sensitive enough, particularly in rural and suburban areas, to actually pinpoint whether a user has been close enough to another person—say within six feet—for a long enough period of time—ten to fifteen minutes—to trigger a contact. in other words, while location applications can be quite revealing about where a user has traveled and about a user’s activities (e.g., whether a user has attended a church or a political rally or sought services at an abortion clinic), they are not particularly useful in identifying other individuals with whom the user has had contact, especially in rural and suburban 114 indiana health law review [vol. 18:107 communities where there are not as many satellites to triangulate a user’s precise geolocation. in sum, location applications are accurate enough to reveal sensitive data, but often not accurate enough for reliable digital disease tracing. proximity applications do not rely on either gps or csli data. instead, they use advanced low-level energy bluetooth technology that is available on newer smart devices. the bluetooth signal strength from application users’ phones measures the distance between the users and tracks their time proximate to each other. for example, if professor terry and i are within six feet of one another for ten to fifteen minutes, our bluetooth proximity applications on our phones are going to capture and log that interaction. if one of us tests positive for covid-19 within two weeks of our interaction, the application will send the other an exposure notification. proximity applications are preferred over location applications on privacy and effectiveness grounds because they are superior at capturing meaningful contacts but do not divulge a user’s sensitive activities or associations (such as whether a user attended a scientology church service or a political rally last weekend). there is considerable variation as to how proximity applications work once they log a contact. i am going to over-generalize here, but i will try to frame up these variations by separating the major data collection approaches that attend to proximity applications into three broad categories: (1) centralized data collection; (2) semi-decentralized data collection; and (3) decentralized data collection. let’s do a quick overview of each category. singapore’s “tracetogether” program provides a paradigm example of the centralized or top-down data collection approach. the “tracetogether” program trusts a centralized authority—the singapore ministry of health—to collect user contact information, including users’ phone numbers, email addresses, and physical addresses. let’s go back to my previous example where professor terry and i both have a bluetooth proximity application active on our phones and those applications logged our potential exposure contact. if we were on the singapore platform, pertinent information on our phones—including our unique user identifiers and contact information—would be uploaded from our phones into a centralized database operated and controlled by the singapore ministry of health. if i then test positive for covid-19, my positive test goes into the system so that professor terry and all of my other contacts can be notified. the department of health thereafter reaches out to professor terry and those other contacts to ensure that they are aware of the potential exposure, can isolate, and get tested. in singapore, if a public health department is notified that someone has tested positive, the department is responsible for uploading that information into the database. individuals who test positive can also upload that information to the centralized database themselves. the centralized database, therefore, collects a lot of individual user information. there are digital trace-and-trace platform options, however, that take a less centralized and more middle-ground approach by delegating more agency to individual users. in these systems, the central authority has less access to sensitive user data. the user has more autonomy to decide when and what to upload to the database and more uploaded information is de-identified. so, in our ongoing hypothetical, once i test positive in a semi-decentralized system, the application 2021] public health surveillance in the context of covid-19 115 uploads my phone’s unique user identification to the centralized database but not my name, email, or residential address. the semi-decentralized database then triggers an automatic ping or exposure alert to my contacts, including professor terry, instead of contacting me or professor terry directly because the system does not have any of our identifiable contact information. the reason why these systems are deemed semi-decentralized instead of decentralized is because deidentified information is uploaded and shared with a central database automatically. the final category of proximity application data collection is the decentralized notification platform. this is the type of system that google and apple collaborated to develop with the aim of maximizing user privacy. in this system, there is no central authority that maintains or has access to a centralized database. instead, there is a public database that collects and broadcasts unique user identifiers. this system neither collects nor stores any personally identifiable information. such decentralized systems do alleviate many—but not all—of the privacy concerns raised by covid-19 digital contact tracing. this is because it is likely impossible to truly de-identify any data in modern times. experts have proved exceptionally adept at re-identifying purportedly de-identified data because so much of our personal data is already publicly available. it is an open question whether these lingering re-identification issues can be ameliorated with robust encryption and other security safeguards. proximity track and trace technology platforms face additional challenges in the united states. first, their ability to succeed hinges on their widespread adoption which, in turn, hinges on widespread public trust of the platform and its underlying technology as well as the government actors involved. the conventional wisdom is that we would need 80% of all people who have smartphones in the u.s. to adopt and use proximity contact tracking applications to mitigate the spread of covid-19. this means that nearly 60% of the american public would have to download and use these applications. given the widespread mistrust in these applications that currently exist in the united states, however, achieving a 60% proximity application user rate seems unlikely anytime soon. polls have shown that more than half of americans either do not have access to technology that would permit them to participate in digital contact tracing or simply will not use the applications if they do.8 these poll results are quite believable if you compare them to the participation information that we have gleaned over the months about americans’ willingness to communicate with traditional contact tracers. when new york city’s contact tracers started reaching out by phone to individuals who had contracted covid19 in june 2020, only 42% of those people would provide the tracers with even 8. reuters staff, most americans cannot or will not use covid-19 contact tracing apps: poll, reuters (apr. 29, 2020), https://www.reuters.com/article/us-health-coronavirus-techtracing/most-americans-cannot-or-will-not-use-covid-19-contact-tracing-apps-polliduskbn22b2to [https://perma.cc/aqs2-5tm8]. 116 indiana health law review [vol. 18:107 a single contact. and only 58% to 60% bothered to answer their phones at all. the state of maryland has experienced even worse results, reporting that a mere 25% of the individuals phoned by contact tracers take the call. even more dire, florida’s miami-dade public health department has only had success reaching 18% of individuals who have contracted covid-19. although the united states may never reach efficacious rates of digital contact tracing participation, it warrants noting that every contact traced potentially saves lives. there are, however, at least two additional problems with digital contact tracing: over-inclusivity and under-inclusivity. first, bluetooth proximity technology can lead to false positive exposure notifications because of its inability to discern if there are barriers between contacts that significantly lower the risk of covid-19 transmission. the technology, for example, fails to account for the fact that there may well be walls in between people who are six feet apart. if you live in a new york city high-rise building and you are only separated from a neighbor by a shared wall, the technology could potentially count you as an exposure risk to your neighbor even though you and your neighbor live in separate apartments and have had no in-person contact. also, assume professor terry and i are driving on the highway in parallel lanes and we both stop at a red light. bluetooth technology would not discern that we were in separate vehicles with our windows up and, therefore, pose little to no exposure risk to one another. bluetooth proximity applications, therefore, run the risk of constantly overnotifying people notwithstanding minimal chance of exposure. the technology also cannot ascertain whether potential contacts are wearing personal protective gear—such as a mask or a face shield—when they are proximate to one another. it would not count, for example, for someone who was wearing a hazmat suit. this runs the risk of exposure notification fatigue for health care and other essential workers who wear ppe as a matter of course and have a high number of daily contacts. perhaps even more problematic is the fact that the technology is underinclusive and therefore, produces false negatives. as i have already discussed, the proximity contact tracking applications only work if a user has a newer device, an adequate data plan, and has downloaded and activated the application. but even that is not enough. the user also has to carry the device on their person at all times in order for the application to be effective. imagine going to a relative’s home and leaving your phone in your coat that you hang on a hook near the front entrance of the residence. your relative’s phone is charging on a stand in her bedroom during your visit. the two of you sit within six feet of one another for approximately two hours catching up. your relative later tests positive for covid-19, but you never receive an exposure notification notwithstanding your extensive proximity to her because your phones were never within six feet of one another. proximity applications treat your phone as a proxy for your body. as a result, whenever a person’s phone turns out to be a poor proxy, these applications run a significant risk of under-inclusive exposure notification. the other thing i want to point out is that bluetooth low-energy signaling is constant work for your mobile device and, therefore, drains the device’s battery quickly. so, yet another concern that attends to this technology is whether it is even possible for users to keep their phones operating throughout the day if they 2021] public health surveillance in the context of covid-19 117 are running the application in the background. at some point, users are going to be hyper-incentivized to disable the application so that they can preserve the battery on their devices to use those devices for other purposes. so much for the imminently positive news about the technology. an ancillary interesting issue is whether there has been widespread adoption of digital contact tracing technology outside the united states. as it turns out, there has been a relatively low uptake of digital contact tracing globally. there are, however, at least a few countries that have adopted the technology with some success. as previously mentioned, singapore adopted its centralized “tracetogether” application in march 2020 and switzerland became the first country to release the decentralized google-apple exposure notification application in may 2020. ireland and germany also have launched digital contact tracing applications with open-source codes that anyone can inspect, and those countries have realized relatively high application adoption rates with their citizens. taiwan has also been lauded for its successful digital contact tracing by involving its citizens in the development and deployment of the surveillance platforms.9 in all fairness, taiwan may be a cultural democratic outlier in this context. this is because the country suffered a severe acute respiratory syndrome (“sars”) epidemic in 2003 and, therefore, was culturally poised to aggressively contain and mitigate the spread of covid-19. it is impossible to fairly assess popular sentiment toward surveillance technology without accounting for a nation’s collectivist versus individualist cultural leanings as well as its recent history with contagion. while ireland and switzerland appear to be succeeding with digital covid19 surveillance, other western nations have realized opposite results. norway and the united kingdom, for example, adopted but then quickly abandoned the use of digital track and track technology due to low uptake. the united states also has had little success with either adoption or uptake of covid-19 digital surveillance. in a recent survey, only four states’ public health authorities indicated that they intend to use the google or apple exposure notification application. an expert at the bergman klein center at harvard university recently announced that he does not believe that digital contact tracing will be widely and successfully adopted in the united states unless things change dramatically in the near future. i would submit that it nonetheless is important to understand the technology given our potential to be digitally tracked and traced while at work or at school, even if the states do not adopt the technology. in the meantime, i would recommend to those that are interested in national and global developments regarding digital contact tracing to visit the massachusetts institute of technology’s covid-19 digital contact application tracker, which you can access online by searching for “mit technology review covid tracing 9. andreas kluth, if we must build a surveillance state, let’s do it properly, bloomberg (apr. 22, 2020), https://www.bloomberg.com/opinion/articles/2020-04-22/taiwan-offers-the-bestmodel-for-coronavirus-data-tracking [https://perma.cc/8me4-eyy2]. 118 indiana health law review [vol. 18:107 tracker.” let’s transition now to an overview of the legal powers that attend to government actors during public health emergencies in the united states and the american health data privacy legal regime. it is the states—and not the federal government—that have the most power under the united states constitution during a public health emergency. this is because, while the federal government is confined by its enumerated powers, the tenth amendment to the constitution broadly reserves the police—or public health and safety—power to the states. the federal government’s public health and safety powers traditionally come from its commerce clause and tax & spending clause authority. so, the federal government’s primary role in a pandemic is to declare national emergencies, provide the states with resources and funding to mitigate the contagion, and serve as the source of national coordination. the supreme court affirmed the breadth and scope of the police powers that are reserved to the states to protect public health from the spread of contagious diseases in a pair of cases decided in the early 20th century. the first, and probably more famous of those cases that warrant discussion, is jacobson v. massachusetts, which was decided by the united states supreme court in 1905.10 that case involved a cambridge, massachusetts pastor, henning jacobson, who refused to be vaccinated in violation of cambridge’s mandatory vaccination ordinance. jacobson argued that the compulsory vaccination law was unreasonable, arbitrary, and capricious and, therefore, ran afoul of his fourteenth amendment rights to due process and equal protection. the supreme court disagreed and broadly deferred to cambridge’s power to protect public health in upholding the compulsory vaccination law. the second important seminal public health powers case that the supreme court decided just before it issued its decision in jacobson is compagnie francaise de navigation a vapeur v. board of health of louisiana.11 in the early 1900s, a ship from europe arrived at the port of new orleans while the city of new orleans was in the midst of a yellow fever outbreak. new orleans public health officials tested the ship’s passengers for yellow fever, and no one was carrying the disease. those officials nonetheless refused to permit the passengers to disembark from the boat and enter new orleans. the question in the case was whether the new orleans board of health had the authority to exclude noninfected individuals from entering the city. the supreme court held that it did on the theory that the city had broad cordon sanitaire public health powers, which permitted it to exclude from its jurisdiction non-infected individuals to prevent them from becoming disease vectors. the takeaway here is that, while not unlimited, the public health powers reserved to the states are vast. as professors larry gostin and lindsay wiley have explained, a state exercise of power to protect health and safety is subject to five balancing principles derived from the jacobson decision—public health necessity, reasonable means, proportionality, 10. jacobson v. massachusetts, 197 u.s. 11 (1905). 11. compagnie francaise de navigation a vapeur v. la. state bd. of health, 186 u.s. 380 (1902). 2021] public health surveillance in the context of covid-19 119 harm avoidance, and fairness.12 so, first, the state must establish that there is a real public health threat. if there is no public threat, the state has no business restricting individual liberties. second, and even if there is an actual public health threat, government intervention must be calibrated to address that threat. the state’s response must be designed to reasonably mitigate the spread of the disease. third, the state’s exercise of its public health powers must be proportional to the public health threat. the burden that the state places on individuals cannot be wholly disproportionate to the expected benefits of those burdens. the fourth jacobson principle is harm avoidance. that is to say that the state’s control measures should not impose a public health harm on individuals. under this principle, pastor jacobson could have won his case if he had established that taking the vaccine would have harmed his health. last but not least, is the principle of fairness, which demands that the state exercise its public health authority equitably and not in a manner that is arbitrary or discriminatory. the federal courts established the principle of fairness in this context in jew ho v. williamson.13 jew ho involved the city of san francisco’s decision to place on quarantine only its chinatown neighborhood despite a citywide outbreak of bubonic plague. mr. ho was a chinatown merchant who challenged the quarantine on the grounds that it was racially discriminatory and irrationally targeted people of chinese descent. the united states district court for the northern district of california agreed with mr. ho and struck down the quarantine as racist, arbitrary, or unreasonable and, thereby, established that it was unconstitutional for a state to exercise its police powers inequitably. the importance of the fairness principle is highlighted in the covid-19 religion cases that have been appealed to the united states supreme court over the last several months. as a general rule, these cases involve a religious group’s attempt to enjoin state covid-19 orders that restrict the group’s right to assemble on due process and equal protection grounds. the court has thus far rejected those challenges. for example, in south bay pentecostal church v. newsome, religious applicants challenged california governor gavin newsome’s order limiting attendance at places of worship to 25% of building capacity or 100 attendees.14 the supreme court refused to enjoin governor newsome’s order because it applied its covid-19 restrictions equally to secular and non-secular indoor gatherings. the united states court of appeals for the sixth circuit, on the other hand, granted injunctive relief to a kentucky church this spring in maryville baptist church v. beshear.15 in that case, the church challenged the kentucky governor’s order that prohibited church members from attending drive-up religious services 12. lawrence o. gostin & lindsay f. wiley, public health law: power, duty, restraint 125-26 (3d ed. 2016). 13. jew ho v. williamson, 103 f. 10 (n.d. cal. 1900). 14. s. bay united pentecostal church v. newsom, 140 s. ct. 1613 (2020). 15. maryville baptist church, inc. v. beshear, 957 f.3d 610 (6th cir. 2020). 120 indiana health law review [vol. 18:107 even if the church members complied with the social distancing and capacity limitations that applied to secular activities. the church argued that the order was unconstitutional because it permitted kentuckians to go to drive-in theaters but proscribed them from attending drive-in religious ceremonies. the sixth circuit agreed with the church and enjoined the governor’s order on fairness principles. as things currently stand, it appears that states do have the authority to conduct digital contact tracing to stymie the spread of covid-19 so long as such tracking comports with the five public health balancing principles. the open question is whether individuals have privacy rights that might place limitations on such digital surveillance. there are at least two sources of constitutional privacy rights that the courts have recognized. first, the supreme court identified a fourteenth amendment qualified right to informational privacy in whalen v. roe.16 the holding in whalen teaches that individuals have a right to informational privacy that must be balanced against the state’s need to protect the public health. the supreme court has also recognized that individuals have a reasonable expectation of privacy in their sensitive health data under the fourth amendment to the constitution. for example, the court held in ferguson v. city of charleston that a state hospital violated patients’ fourth amendment reasonable expectations of privacy by sharing the results of their diagnostic tests with non-medical personnel, including law enforcement.17 the court recently decided an important fourth amendment privacy case, carpenter v. united states, that might impact the scope of constitutional health data privacy protection going forward.18 prior to the carpenter decision, the general rule was that an individual who voluntarily shares their health care data with a third party—who, in turn, shares that information with a government agency—has waived their right to raise a fourth amendment privacy claim. in carpenter, law enforcement had obtained the petitioner’s cell-site location data—which revealed his pertinent whereabouts and movements during the time at issue—from the petitioner’s wireless carrier without his consent and without a warrant. the court rejected the government’s claim that carpenter had waived his right to raise a fourth amendment claim and held that law enforcement was required to obtain a warrant to conduct such csli surveillance over a period of weeks and months. the carpenter decision, therefore, has serious legal implications for digital location contact tracing applications. there are nonetheless numerous fourth amendment exceptions to the warrant requirement that limit an individual’s reasonable expectation of privacy. the government, for example, can conduct warrantless searches at the border—which is expansively defined under american law. and, there are other administrative and special needs doctrines that can undermine fourth amendment protection of sensitive data. moreover, private actors and entities that collect health data for digital contact tracing purposes are not subject to these 16. whalen v. roe, 429 u.s. 589, 603-06 (1977). 17. ferguson v. city of charleston, 532 u.s. 67, 86 (2001). 18. carpenter v. united states, 138 s. ct. 2206 (2018). 2021] public health surveillance in the context of covid-19 121 constitutional constraints. so, that brings us to a discussion about potential statutory privacy protections. hipaa is a federal statute that is largely viewed as synonymous with health data privacy. if covid-19 has taught us anything about health care law, it is that hipaa is one of the most misunderstood laws in the united states. since the inception of the pandemic, individuals have created twitter and other social media accounts dedicated to exposing the myriad misconceptions that americans have about hipaa. so, let me attempt to clear some of those misconceptions about the law. hipaa only applies to a narrow set of covered entities in the traditional health care system, including health care providers, health care insurance companies, health care clearinghouses, and their business associates. hipaa does not apply to employers or third-party application creators or operators, such as google or apple. in addition, hipaa only applies to very particular health information. specifically, the statute only proscribes covered entities from disclosing individually identifying health care information, which the hipaa privacy rule calls “protected health information” (“phi”). health care data that is “de-identified,” therefore, is not protected from disclosure by hipaa. hipaa also includes a dozen “public policy” exceptions that permit even covered entities to disclose phi in certain circumstances to certain other entities. these exceptions permit covered entities to disclose phi for, among other things, health oversight activities, specialized government functions, law enforcement purposes, research activities, as well as to mitigate or avoid serious threats to public health and safety. hipaa’s privacy scheme also precludes individuals from vindicating their rights even when the statute has been violated. the only entity that can enforce hipaa is the department of health and human services’ office of civil rights (“ocr”). ocr recently announced that it will exercise its enforcement discretion during the pandemic and not enforce certain hipaa violations in certain circumstances. in sum, hipaa requires a very narrow set of entities to protect individually identifying health information subject to a broad swath of exceptions. there is no reason to believe that hipaa is going to provide any privacy protections in the context of contact tracking so long as the states delegate their covid-19 digital tracking functions to a state agency that is not covered by hipaa. states also have their own privacy protections, some of which are much more robust than federal protections. there are a small number of states, for example, that have expressly recognized a right to health care data privacy in their constitutions. every state also has enacted a consumer protection statute that provides variable privacy protections. california recently enacted the california consumer protection act (“ccpa”), for example, which is the most comprehensive state-level data privacy scheme in the united states. the ccpa extends to consumers, among other things, the right to correct and delete their data, the right to opt-out of data collection schemes, and the right to privately enforce the statute. the ccpa, however, exempts from its protections hipaacovered entities. recognizing that the collection and storage of sensitive health care 122 indiana health law review [vol. 18:107 information in the context of digital contact tracing is unlikely to be protected by federal law, congress has proposed at least three statutes since april 2020 that are designed to fill the gap. on june 1, 2020, for example, two senators introduced the exposure notification privacy act (“enpa”), which aims to provide americans control over data collected by digital track and trace applications. as currently drafted, the enpa requires digital contact tracing application operators to collaborate with state public health authorities, obtain consent from enrolled users, permit users to withdraw such consent, and permit users to request data deletion. the statute also limits data collection to that which is minimally necessary to implement the application and proscribes operators from using the data for commercial purposes. the enpa does not, however, extend a private right of action to individuals to vindicate their statutory rights. i see that our time is running short. i want to conclude by pointing out that my book chapter addresses all of the topics that we have discussed today pertinent to contact tracing as well as proposes a list of recommendations to state and federal governments that aim to address the significant privacy concerns raised by digital contact tracing. those recommendations contend that any state or federal legislation that is enacted to extend privacy protection to digital contact tracing application users should, among other things: (1) minimize the data collected; (2) permit users to delete and correct their data; (3) assure informed, voluntary participation; (4) respect user autonomy; (5) prohibit discrimination and the dissemination of collected information to non-health authorities; (6) proscribe the commercial use of collected data; (7) mandate government transparency and accuracy; (8) guarantee data security; (9) include a sunset provision; and (10) extend to users a private right of action. immigration policy and public health polly j. price* it cannot be said too often: public health in the united states is underfunded and dangerously fragmented. these longstanding woes are exacerbated each time congress and state legislatures fail to take into account the public health consequences of policies they enact into law. immigration policy is no exception. when we talk about immigration reform, public health is often ignored, even though federal policy with respect to non-citizens vitally affects state and local governments. or worse, immigrants are misrepresented as health threats to the u.s. in ways they are not. our immediate public health emergencies in the u.s. have nothing to do with immigration or immigrants. take, for instance, the fact that hiv is thriving in the south, and is the subject of a new presidential initiative to combat it nationwide.1 measles outbreaks, entirely preventable by vaccination, have occurred across the country in recent years, including in eleven states in the first two months of this year alone.2 hepatitis a, a third-world disease, has spread from city to city in the u.s.3 a strain of drug-resistant tuberculosis that originated at a homeless shelter in atlanta killed four people, and has spread to at least eight other states.4 the opioid epidemic has brought with it skyrocketing rates of infectious diseases * asa griggs candler professor of law and professor of global health, emory university. j.d., harvard law school, 1989, m.a., emory university 1986. andrew carnegie fellow 2017. this article was made possible by a grant from carnegie corporation of new york. the statements made and views expressed are solely the responsibility of the author. 1. charlene flash, san francisco is beating h.i.v. why can’t houston?, n.y. times (mar. 1 , 2019), h t tps:/ /www.nytimes.com/2019/03 /01 /opin ion /hiv-aids-sou th .h tml [https://perma.cc/lyh9-a87t]; andy miller, in new offensive against hiv, metro atlanta is a battleground, wabe (feb. 11, 2019), https://www.wabe.org/in-new-offensive-against-hiv-metroatlanta-is-a-battleground [https://perma.cc/wx9r-hx56]. 2. see measles cases and outbreaks, ctrs. disease control & prevention (mar. 4, 2019), https://www.cdc.gov/measles/cases-outbreaks.html [https://perma.cc/5ccx-u8tb] (reporting 206 confirmed cases of measles in 11 states in first 2 months of 2019); saad b. omer & robert bednarczyk, measles was eliminated. but we can’t be sure it’ll stay that way, wash. post (feb. 11, 2019), https://www.washingtonpost.com/outlook/2019/02/11/measles-waseliminated-we-cant-be-sure-itll-stay-that-way [https://perma.cc/qqm8-lms8] (describing recent state of emergency declaration in washington and outbreaks in seven states in 2015). 3. outbreaks of hepatitis a in multiple states, ctrs. disease control & prevention (mar. 15, 2019), https://www.cdc.gov/hepatitis/outbreaks/2017march-hepatitisa.htm [https://perma.cc/n5gh-qfqu]; lauren weber, remember last year’s hepatitis a outbreak? this year it’s so much worse, huffington post (june 3, 2018), https://www.huffingtonpost. com/entry/hepatitis-a-outbreak-this-year-much-worse_us_5b204e83e4b09d7a3d7829bd [https://perma.cc/m475-bfeh]. 4. nancy badertscher, tb real concern at atlanta homeless shelter, politifact (aug. 19, 2015, 12:00 am), https://www.politifact.com/georgia/statements/2015/aug/19/kasim-reed/tb-realconcern-controversial-atlanta-shelter [https://perma.cc/uj5m-3qms]. 236 indiana health law review [vol. 16:235 related to intravenous drug use, such as hiv and hepatitis c.5 add to this the fact that the u.s. has the highest percentage of citizens without health insurance in the industrialized world.6 lack of preventive healthcare can mean low resilience in the population as a whole. a community’s overall resilience in the face of a contagious disease outbreak is only as strong as the weakest link. scientists say we are long overdue for a naturally occurring pandemic. the world health organization refers to it as “disease x.”7 altogether, it is easy to understand why the possibility of a fast-spreading, deadly epidemic in the u.s. keeps scientists awake at night.8 blame whoever you like—anti-vaxxers, counter-productive laws and policies, underfunded city services—but do not blame immigrants for these home-grown problems. non-citizens living in or visiting the u.s. are on the whole healthier than the native-born u.s. population.9 immunization rates among them are higher, too.10 an “imported” disease like sars or avian flu is as likely to be spread by a returning u.s. traveler as a migrant at the border. recall the public outcry that followed news that an atlanta lawyer with drug-resistant tuberculosis had traveled on several international flights against the orders of public health officials, leading to congressional hearings and renewed interest in federal 5. see ripon advance news service, lance introduces bill to counter rise in infectious diseases fueled by opioid epidemic, the ripon advance (mar. 23, 2018), https://riponadvance. com/stories/lance-introduces-bill-counter-rise-infectious-diseases-fueled-opioid-epidemic/ [https://perma.cc/xzr5-wnst]. 6. america is a health-care outlier in the developed world, the economist (apr. 26, 2018), https://www.economist.com/special-report/2018/04/26/america-is-a-health-care-outlier-inthe-developed-world [https://perma.cc/xz56-nann]. 7. list of blueprint priority diseases, who, https://www.who.int/blueprint/prioritydiseases/en/ [https://perma.cc/r63t-z9m8] (“disease x represents the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease.”). 8. see, e.g., jonathan quick, the looming epidemic threat, the guardian (mar. 18, 2018), https://www.theguardian.com/commentisfree/2018/mar/18/end-epidemics-aids-ebola-sarssunday-essay [https://perma.cc/93e8-e5t4]; lauren weber, more dangerous outbreaks are happening. why aren’t we worried about the next epidemic?, huffington post (july 18, 2018, 5:23 pm), https://www.huffingtonpost.com/entry/outbreaks-epidemic-preparedness_ us_5b4f85fbe4b0de86f4892daa [https://perma.cc/6uhp-463r]. 9. see patricia illingworth and wendy e. parmet, the health of newcomers: immigration, health policy, and the case for global solidarity 13 (2017) (“indeed, with rare exceptions, newcomers—a term we use to refer to all nonnative residents, regardless of their citizenship or immigration status—are generally healthier than natives.”). 10. alex nowrasteh, measles vaccination rates and immigration, cato inst. (july 11, 2016, 1:20 pm), https://www.cato.org/blog/measles-vaccination-rates-immigration [https://perma.cc/y9wk-zc7l] (noting who and unicef report showing immigrant sending countries, including el salvador, mexico, vietnam, cuba, and china all have higher measles vaccination rates than the u.s.). 2019] immigration policy and public health 237 quarantine power.11 as wendy parmet and others have reminded us, the u.s. has a long history of wrongly blaming immigrants both for diseases that spread globally through travel and trade as well as for our own governmental shortcomings.12 immigration policy in the u.s. does have important ramifications for public health. but it is not because immigrants themselves pose a disproportionate health threat to citizens. and we cannot keep contagion out or protect ourselves from the world’s pandemics by some fantasy of closing borders or erecting walls. birds and mosquitoes, carriers of lethal viruses, are notorious disrespecters of walls. and we shouldn’t forget that we export diseases to other countries, too. in short, the greatest public health threats in our nation today are ones that have originated here, not ones brought from the outside. but it also makes no sense to create immigration policies that may increase the risk that contagious disease outbreaks will spread. yet we are doing just that. as i describe below, the u.s. department of homeland security proposes to treat immigrant access to healthcare in a punitive fashion that even it admits “could lead to . . . increased prevalence of communicable diseases, including among members of the u.s. citizen population who are not vaccinated.” local health departments in the u.s. already struggle against the odds. this new federal policy needlessly makes that struggle even harder. i. the critical role of the local health department state and local health departments are key to protecting the nation from epidemics. the burden of public health defense falls to 2,684 state, tribal, and local health jurisdictions.13 contrary to what many people might expect, the federal government is not in charge in the event of an epidemic outbreak affecting the nation. the cdc plays a very limited role in combatting contagious disease in the u.s. the cdc cannot intervene, direct, or provide assistance unless states individually invite them to do so.14 even then, the cdc cannot provide medical treatment or take other steps we might expect, although its staff possesses the best scientific and medical expertise in the world. 11. polly j. price, do state lines make public health emergencies worse? federal versus state control of quarantine, 67 emory l.j. 491, 521-22 (2018); david brown, the two faces of tuberculosis, wash. post (june 19, 2007), http://www.washingtonpost.com/wpdyn/content/article/2007/06/15/ar2007061502130.html [https://perma.cc/5ke6-qdsn]; vikki valentine, a timeline of andrew speaker’s infection, npr (june 6, 2007), https://www.npr.org/ news/specials/tb/ [https://perma.cc/gw2x-cu7h]. 12. illingworth & parmet, supra note 9; guenter b. risse, plague, fear, and politics in san francisco’s chinatown (2012); howard markel, when germs travel (2004); alan kraut, silent travelers: germs and the immigrant menace (1995); howard markel & alexandra minna stern, the foreignness of germs: the persistent association of immigrants and disease in american society, 80 milbank q. 757 (june 6, 2003). 13. price, supra note 11, at 516. 14. id. at 514. 238 indiana health law review [vol. 16:235 local health departments, then, are the most essential barrier to stop the spread of contagious disease within neighborhoods, between cities, and among u.s. states. we rely on them to contain outbreaks of contagious disease before they can spread out of control. yet as the “public health” responsibilities of local governments have become more broadly defined, their jobs have become more complicated. for example, while local health departments play a key role in ensuring food safety, their core function is to stop the spread of contagious disease—the reason health departments were established at the state and local level more than a century ago.15 this core function requires a number of steps that have not changed with advances in medical science: investigate the source of an outbreak of contagious disease. stop further spread of the disease through counter-measures that include isolating the sick if they are contagious. find people who may have been exposed but do not know it. and, if necessary, quarantine those who have been exposed in order to prevent further spread.16 health departments in the u.s. perform remarkably well, given that they are unevenly funded and must constantly solicit political support from elected officials. heroic efforts of state and local health departments, for example, account for the fact that the u.s. has thus far contained the spread of drugresistant tuberculosis below levels that globally have become alarming, though the system is precarious because of its fragmentation and the unwillingness of many local governments to pay for it.17 but the reality is that federal law and immigration policy create distinctions between citizens and non-citizens that make the jobs of local health departments harder. the mission of the local health department is to protect “population” health, the relevant criteria being “person,” not visa or citizenship status. the immigration status of the local population does not matter, and public health workers investigating an outbreak, or offering immunizations, do not ask. some health departments go to great lengths to reassure residents that their citizenship or immigration status is irrelevant.18 why? among other reasons, because health departments need the cooperation of everyone in the event of a contagious disease outbreak or public health emergency. public health workers need to be trusted, 15. for an insightful historical analysis of the peculiar form of public health federalism in the u.s., see wendy e. parmet, health care and the constitution: public health and the role of the state in the framing era, 20 hastings const. l.q. 267 (1992). 16. these traditional public health strategies are described in james hodge, jr., public health law in a nutshell 12 (3d ed. 2017); lawrence o. gostin, pubic health law: power, duty, restraint 421-50 (2d ed. 2008). 17. polly j. price, opinion, if tuberculosis spreads . . ., n.y. times (july 9, 2014), https://www.nytimes.com/2014/07/09/opinion/if-tuberculosis-spreads.html [https://perma.cc/t7t4nm2p]. 18. see, e.g., alameda county pub. health dep’t, immigration and public health: an issue brief (july 2017), http://www.acphd.org/media/470384/immigration.pdf [https://perma. cc/l4gk-yk9e] (“nearly 1 in 3 alameda county residents is an immigrant. this includes at least 526,148 naturalized u.s. citizens, lawful permanent residents, temporary migrants, humanitarian migrants, and other foreign-born residents who were not u.s. citizens at birth.”). 2019] immigration policy and public health 239 not studiously avoided. people without documented status may have an incentive to avoid interacting with any government official, hence the extraordinary efforts of public health workers to distinguish their function from law enforcement. many without legal immigration status have lived in the community for years and have u.s. citizen children or spouses. these long-term residents may inadvertently end up becoming a health threat, and yet be afraid to interact with government officials responding to a public health emergency, especially if there is a need to interact with police in the event of quarantine for suspected exposure. contact tracing can be the most problematic if someone is afraid that disclosure of a person’s contacts could somehow lead to “discovery” of immigration status. an additional problem has to do with the way health departments become aware of local outbreaks in the first place. hospitals and medical providers are required to report to their local health department anyone diagnosed with specified contagious diseases, like tuberculosis, measles, and hepatitis.19 the health department then begins an investigation to see if the case is isolated, or is part of an emerging pattern of reports that would constitute an “outbreak” or even a public health emergency. if people avoid seeking healthcare because they don’t have insurance or are afraid their immigration status might become known, a contagion can get out of control before public health officials are even aware of it. most non-citizens, including millions who are present in the u.s. legally, are not eligible for any form of subsidized health insurance, nor are they eligible for insurance through an employer because they are prohibited from working.20 medicare and medicaid are off limits for most non-citizens, with very few exceptions. many visas for legal immigrants prohibit employment, meaning employer-subsidized insurance is not available to them. the affordable care act, while expanding access to health insurance for millions of u.s. citizens, excluded undocumented immigrants and even many legal immigrants.21 non-citizens, both those here legally and those who are not, are disproportionately uninsured compared to u.s. citizens, meaning they are less likely to receive preventive medical care or seek routine care at an early stage of illness.22 so while citizenship and immigration status matter for access to health care, citizenship remains irrelevant from the perspective of a local health department. 19. see, e.g., notifiable conditions, tex. dep’t state health servs. https://www.dshs. texas.gov/idcu/investigation/conditions [https://perma.cc/au5g-cban]. 20. see jennifer y. seo, justice not for all: challenges to obtaining equal access to health care for non-citizen immigrants in the united states, 3 geo j. l. & mod. critical race perspectives 143 (2011); tamara forys, left out in the cold: how the united states’ healthcare system excludes immigrants, 17 annals health l. 351 (2008). 21. maggie morgan, healthy regardless of status: expanding access to healthcare for noncitizens, 15-02 immigr. briefings 1 (2015). 22. id. at 1. it is also worth noting that all immigrant groups pay more in taxes than they consume in social benefits, including refugees. see rejected report shows revenue brought in by refugees, n.y. times (sept. 19, 2017), https://www.nytimes.com/interactive/2017/09/19/us/ politics/document-refugee-report.html [https://perma.cc/8ce8-r2c8]. 240 indiana health law review [vol. 16:235 given that it’s unlikely we will commit more federal resources to the health needs of non-citizens, it is all the more important for state legislatures to reinvest in public health after decades of declining financial commitments.23 but even states with the foresight to invest in the health of all its residents might in the event of an epidemic see that investment quickly erode, given the speed with which viruses can travel across state lines and the financial incentives state and local governments have to pass along their public health problems to other jurisdictions. and while from a public health perspective it might be desirable to make healthcare more broadly accessible, including to non-citizens who cannot afford it, i want to be clear that i am not arguing here that the u.s. should do so. every nation restricts in some way the public services it provides to newcomers. my purpose instead is to highlight a new federal policy that penalizes immigrants if they use the few government-funded health services to which they are already entitled by law. to understand why this matters, i provide some background on what congress has said about restricting publicly-funded health care on the basis of citizenship. ii. prwora and its forgotten exception the u.s. used to be a bit more generous with the healthcare safety net for immigrants who were on the path to u.s. citizenship, but welfare reform legislation in 1996, the personal responsibility and work opportunity act (prwora),24 generally restricted non-citizens’ eligibility for public benefits.25 prwora barred all lawful permanent residents from receiving means-tested, federally funded assistance, including medicare and medicaid, for the first five years in the country. prwora also excluded entirely many others with legal status who were previously eligible. and it barred unauthorized immigrants from government-funded health assistance altogether, except for medical emergencies. medicaid was previously available to lawful permanent residents with no waiting period, as well as to a vast number of non-citizens residing in the u.s. “under color of law,” a catch-all category for non-citizens living in the u.s. legally but with an uncertain path to citizenship.26 the immediate effect of prwora was to take away large amounts of federal 23. see, a funding crisis for public health and safety: state-by-state health funding and key health facts, trust for america’s health, https://www.tfah.org/report-details/a-fundingcrisis-for-public-health-and-safety-state-by-state-and-federal-public-health-funding-facts-andrecommendations [https://perma.cc/gg55-wtzc]. 24. prwora, pub. l. no. 104-193, 110 stat. 2105 (1996) (codified as amended in scattered sections of 8 and 42 u.s.c.). 25. akiesha r. gilcrist, undocumented immigrants: lack of equal protection and its impact on public health, 34 j. legal medicine 403, 405 (2013). 26. julia field costich, legislating a public health nightmare: the anti-immigrant provisions of the “contract with america” congress, 90 ky. l.j. 1043, 1046 (2002) (explaining the prucol doctrine). 2019] immigration policy and public health 241 healthcare money from states with the largest populations of non-citizens. in response, some states funded their own programs for impoverished non-citizens, and ever since have had to negotiate against attempts by the executive branch to eliminate them.27 prwora included an exception for emergency medical care, regardless of citizenship or immigration status.28 that exception is enshrined today in the emergency medical treatment and labor act (emtala), a federal law that requires hospitals to treat and stabilize anyone coming to an emergency department, regardless of their insurance status or ability to pay. hospitals can receive some reimbursement for emergency medical services provided to people without health insurance and no ability to pay, including undocumented immigrants. congress recognized that it was unseemly to let people die because they couldn’t afford emergency medical care. but when congress enacted prwora in 1996, it was also aware that communicable disease control is population-based, not citizenship-based. so, in addition to the emergency medical care provision, it included exceptions for “[p]ublic health assistance for immunizations” and “for testing and treatment of symptoms of communicable diseases.”29 congress did not say what “treatment of symptoms of communicable diseases” meant, or who pays for it. but it was at least a recognition that one reason to provide medical care for people with a contagious disease is to prevent further spread. medical countermeasures necessary to protect the community were not to be withheld on account of citizenship or immigration status. a scant legislative history sheds some light on what congress meant by the odd phrasing, “treatment of symptoms of communicable diseases.” differences between the house and senate versions of prwora were resolved by a conference committee, including a disagreement over the wording of the “communicable diseases” exception. the original senate version stated that “the exception for communicable diseases is limited to treatment of the disease itself and must be triggered by a finding by hhs that testing and treatment of a particular disease is necessary to prevent its spread.”30 the house version did not require a finding by hhs.31 the conference committee ultimately adopted the language used in the house version, “treatment of symptoms of communicable disease,” explaining in its report: “the allowance for treatment of communicable diseases is very narrow. the conferees intend that it only apply where absolutely necessary to prevent the spread of such diseases. this is only a stop-gap measure until the 27. for an overview of the complex rules concerning immigrant access to publicly-funded healthcare, see mehda d. makhlouf, health justice for immigrants, 4 u. pa. j.l. & pub. aff. 235 (2019); katherine g. footracer, immigrant health care in the united states: what ails our system?, 22 j. amer. acad. phys. assts. 33 (2009). 28. prwora, §115(f), pub. l. no. 104-193, 110 stat 2015 (1996). 29. id. 30. h.r. conf. rep. 104-725, 104th cong., 2d sess. 1996, 1996 u.s.c.c.a.n. 2649, at 2767. 31. id. 242 indiana health law review [vol. 16:235 deportation of a person or persons unlawfully here. it is not intended to provide authority for continued treatment of such diseases for a long term.”32 the conference committee’s explanation shows little understanding of the complexities of immigration law. “until deportation” is a process that can take years because of a longstanding (and worsening) backlog in immigration courts, among other reasons. moreover, the public heath exception applies to all noncitizens, not just those illegally present. how does this explanation make sense for legal immigrants not subject to deportation at all, assuming the conferees were aware such persons might have come to the u.s. under two hundred different visa types?33 this is an immigration law fantasy world. and it’s a public health fantasy world, too. how do medical professionals treat “symptoms only” of any communicable disease as a “stop-gap measure”? likely, both houses of congress intended in a general way that treatment provided to a non-citizen in order to prevent a wider public health threat not morph into expensive treatment for non-contagious ailments a patient might also have—diabetes, dialysis for renal failure, cancer. they may also have had in mind hiv/aids. at that time, immigrants with positive hiv status were already barred from entering the country.34 the cost of healthcare for anyone suffering from aids was (and remains) enormous. perhaps congress wanted to make clear that medicaid funds could not be used to treat non-citizens with aids, and it gave no thought to whether treatment of “symptoms only” of a host of other contagious diseases would be at all effective as a public health measure.35 but unlike the emergency medical care exception, no federal funds seem ever to have been allocated for medical treatment to prevent the spread of contagious disease. this “public health” exception was essentially an unfunded mandate for a task state and local governments already undertook. health departments would continue to isolate cases of communicable disease when necessary to prevent further spread, carrying the costs of care for those patients who were uninsured. in the same year that congress enacted prwora, it also passed sweeping 32. id. at 2767-68. 33. eligibility for u.s. visas, eligibility.com, https://eligibility.com/visas [https://perma.cc/ f8zy-y57l] (last updated january 28, 2019); see generally virgil wiebe, the immigration hotel, 68 rutgers u.l. rev. 1673 (2016) (describing range of both immigrant and nonimmigrant visas). 34. see rebecca kidder, administrative discretion gone awry: the reintroduction of the public charge exclusion for hiv-positive refugees and asylees, 106 yale l.j. 389, 390 (1996) (describing congress’s codification of the hiv exclusion in 1993); see also sherryl s. zounes, positive movement: revisiting the hiv exclusion to legal immigration, 22 geo. immigr. l.j. 529, 531-32 (2008) (recounting subsequent history). the restriction on immigrant visas was not removed until 2010. 35. non-citizens may be refused entry to the united states on a variety of health grounds, including having “a communicable disease of public health significance.” 8 u.s.c.a. §1182(a)(1)(a) (2019). see also polly j. price, infecting the body politic: observations on health security and the “undesirable” immigrant, 63 u. kan. l. rev. 917 (exploring history of healthbased exclusions). 2019] immigration policy and public health 243 immigration legislation designed to address the growing population of undocumented immigrants in the u.s. among other things, the illegal immigration reform and immigrant responsibility act of 1996 (iiraira)36 greatly expanded the grounds for deportation for crimes committed in the u.s. and made non-citizens convicted of those crimes subject to expedited removal. iiraira also strengthened the “public charge” ground of admissibility in the immigration and nationality act.37 for well over a century, immigration authorities have had the ability to exclude and deport non-citizens on poverty grounds—that they are or might in the future become reliant on government services or support.38 non-citizens can be denied entry to the u.s. if they are believed to be “likely at any time to become a public charge,” a term that is not defined in the statute.39 in addition, immigrants can lose their visa status and be removed if they become a public charge within five years after admission, if the reason they became a public charge existed before they came to the u.s.40 congress did not further define “public charge” in iiraira, but it specified that immigration authorities must take into account a person’s age, health, family status, financial resources, education, and skills when determining admissibility.41 congress did not state whether the receipt of public benefits would count. the new emphasis on “public charge” created immediate confusion among non-citizens about whether any form of public assistance for healthcare might make them a “public charge” in the eyes of immigration authorities. non-citizens who were still eligible for medicaid or state funded health programs disenrolled. clinics serving migrant workers saw a dramatic decrease in patient visits. it was an alarming situation, all due to the uncertainty of whether acceptance of government-funded health insurance, reduced-fee or free healthcare could prevent legal immigrants from obtaining citizenship, or even lead to deportation. the state department noted that confusion over prwora and the “public charge” provision “led many persons in the immigrant community to choose not to sign up for important benefits, especially health-related benefits, which they were eligible to receive, as they were concerned this would affect their or a family member’s immigration status.”42 the problem was of such magnitude that government experts “began to fear an adverse impact on public health and welfare.”43 concerned that fear of obtaining necessary medical care was jeopardizing the 36. iiraira, pub. l. no. 104-208, 110 stat. 3009-546 (1996). 37. § 531, 110 stat. at 3009-674 to 3009-675 (codified at 8 u.s.c. § 1182(a)(4)(b)). 38. leo m. alpert, the alien and the public charge clauses, 49 yale l.j. 18 (1939). 39. id. 40. see generally cong. research serv., r43220, public charge grounds of inadmissibility and deportability: legal overview (2017); linton joaquin & braden cancilla, protecting immigrants and the community: a new approach to public charge determinations, 76 interpreter releases 885 (1999). 41. 8 u.s.c.a. § 1182(a)(4)(b) (2019). 42. joaquin & cancilla, supra note 39, at 886. 43. id. 244 indiana health law review [vol. 16:235 general public, hhs worked with the immigration and naturalization service (ins)44 to address the situation. in 1999, ins released a “guidance statement” clarifying that health services other than for long-term care would not be counted in “public charge” determinations.45 the guidance exempted medicaid and other “health insurance and health services (other than public benefits for costs of institutionalization for long-term care),” including “public benefits for immunizations and for testing and treatment of symptoms of communicable diseases, and use of health clinics.”46 the purpose of its action was to “reduce the negative public health consequences” generated by confusion over what type of public benefits would count.47 the situation had become “particularly acute” for contagious disease control.48 non-citizens were avoiding medical care to an extent that it jeopardized the general public.49 contemporaneous with the ins policy announcement in 1999, hhs deputy secretary kevin thurm released a statement supporting it: we have been concerned for quite some time about the confusion and fear in immigrant communities that accepting certain government benefits would jeopardize their ability to become legal u.s. residents. it’s especially important to ensure access to health care for immigrants, so i am particularly pleased that virtually all health services and benefits are exempt from the ‘public charge’ test for admission, adjustment, or deportation.50 it had taken three years to resolve the confusion congress had created in 1996 with respect to health services. since 1999, the federal government has assured non-citizens they need not fear seeking health treatment, benefiting the efforts of local health departments throughout the nation to protect community health. but the trump administration announced its desire to void that policy in early 2017, as part of what immigration scholar mae ngai and others denounced as a broader effort to punish legal immigrants for being poor.51 44. in 2003, congress discontinued the federal agency known as the immigration and naturalization service, transferring its functions to three new agencies: u.s. citizenship and immigration services (“uscis”), u.s. immigration and customs enforcement (“ice”), and u.s. customs and border protection (“cbp”). 45. inadmissibility and deportability on public charge grounds, 64 fed. reg. 28,676 (may 26, 1999), https://www.federalregister.gov/documents/1999/05/26/99-13188/inadmissibility-anddeportability-on-public-charge-grounds [https://perma.cc/4ppe-7xrc]. 46. id. at 28682, 28685. 47. id. at 28676. 48. id. 49. id. 50. quoted in: hooper, lundy & bookman, inc., feds propose exemption from immigration decisions for specific health services, 7 cal. health l. monitor 8, 8 (june 7, 1999). 51. torrie hester, mary e. mendoza, deirdre moloney & mae ngai, perspective: now the trump administration is trying to punish legal immigrants for being poor, wash. post (aug. 9, 2018), https://www.washingtonpost.com/news/made-by-history/wp/2018/08/09/now-the-trump2019] immigration policy and public health 245 iii. the new federal “public charge” rule on october 10, 2018, the department of homeland security (dhs) published its long-expected proposed rule rescinding the 1999 ins policy and redefining “public charge.”52 dhs proposes to consider the use of any government benefit, including health services funded by states or public-private partnerships, in “public charge” determinations for admissibility, including requiring “all aliens seeking an extension of stay or change of status to demonstrate that they have not received, are not currently receiving, nor are likely to receive, public benefits as defined in the proposed rule.”53 the rule redefines “public benefits” to include essentially all government-funded health services, a 180 degree turn from what it would replace: a sensible policy made with the input of hhs whose job it is to protect the nation from epidemics. even worse, dhs admits that its proposed rule “could lead to . . . increased prevalence of communicable diseases, including among members of the u.s. citizen population who are not vaccinated.”54 but it’s not just vaccine-preventable diseases public health officials worry about. that statement is frighteningly naïve from a medical science standpoint, because it fails to recognize the host of viral diseases for which no vaccine is available. and those are the ones we know about, not some novel flu mutation or the world health organization’s “disease x.”55 this is the reason hhs and federal immigration authorities clarified the public charge rules in 1999—it was already evident that avoidance of health services had made the spread of communicable disease an increasing threat to everyone. the proposed rule is not yet law as dhs must consider the comments it received before the rule becomes final. if finalized in its current form, however, the rule is almost certain to be reversed by a court under the administrative procedure act, a fate that has happened to numerous trump administration initiatives for failing to follow the basic rules of administrative lawmaking.56 other scholars have catalogued the numerous grounds upon which a court could invalidate the proposed rule,57 and the city of baltimore has filed a lawsuit administration-is-trying-to-punish-legal-immigrants-for-being-poor [https://perma.cc/9nrp-j3t2]. 52. inadmissibility on public charge grounds, 83 fed. reg. 51,114 (oct. 10 2018), https://www.federalregister.gov/documents/2018/10/10/2018-21106/inadmissibility-on-publiccharge-grounds [https://perma.cc/b2a2-dcwk]. 53. id. at 51,114. 54. id. at 51,270. 55. world health organization, supra note 7. 56. see, e.g., margot sanger-katz, for trump administration, it has been hard to follow the rules on rules, n.y. times (jan. 22, 2019), https://www.nytimes.com/2019/01/22/upshot/fortrump-administration-it-has-been-hard-to-follow-the-rules-on-rules.html [https://perma.cc/t2377xa7]. 57. see, e.g., janet m. calvo, trump order mandating deportation for health service use: not legally sufficient, 107 am. j. pub. health 1240 (2017) (reviewing proposed executive 246 indiana health law review [vol. 16:235 for harm it has been caused by what it terms the trump administration’s “crusade” to change the definition of public charge behind closed doors.58 rather than repeat those arguments here, i address a point that threatens the general public, citizens and non-citizens alike. the proposed rule entirely ignores the basis for the agency’s prior guidance—the need to clarify public charge rules to protect the nation’s health from communicable disease threats. nowhere in the 158-page document is there any acknowledgement of the public health concern that drove the policy the trump administration now seeks to replace. a new administration can change administrative rules and policies, of course, but they have to provide a reasoned explanation for doing so.59 failing to address the primary rationale for the rule an agency seeks to change is an obvious violation of the administrative procedure act’s requirement that a change in policy not be “arbitrary or capricious.”60 it’s a pretty minimal standard to meet. but just proposing the rule probably accomplished the goal the trump administration made known it would pursue from the beginning of his administration.61 it has already sown the kind of confusion that hhs used to think was important to prevent.62 but the proposed rule also shows why making immigration policy in the absence of hhs input is such a bad idea. in implementing a policy to discourage would-be immigrants who are poor, the federal government has lost sight of “population” health that is the domain of the local public health department. where is hhs in the public charge policy today? did the hhs assistant secretary in charge of public health preparedness and defense have any say? hhs took the leading role after prwora to help ameliorate the threats to public health congress had created. but that agency is notably absent in the process that brought about the proposed public charge rule. the proposed rule is an example of what can happen when immigration issues are viewed strictly from an enforcement perspective and not also from a population health perspective. this order). 58. complaint for declaratory and injunctive relief at 28, baltimore v. trump, case 1:18-cv03636-elh (d. md. nov. 11, 2018), https://democracyforward.org/wp-content/uploads/2018/ 10/fam-change-complaint-as-filed.pdf [https://perma.cc/z9x3-x2k2]; sarah meehan, baltimore sues trump administration over immigration policy city says keeps residents from seeking benefits, balt. sun (nov. 29, 2018, 8:05 am), https://www.baltimoresun.com/news/ maryland/politics/bs-md-ci-trump-immigration-lawsuit-20181128-story.html. 59. motor vehicle mfrs. ass’n v. state farm, 463 u.s. 29 (1983). 60. 5 u.s.c.a. §706(2)(a) (2019). 61. see michael fix & randy capps, leaked draft of possible trump executive order on public benefits would spell chilling effects for legal immigrants, migration pol’y inst. (feb. 2017), https://www.migrationpolicy.org/news/leaked-draft-possible-trump-executive-order-publicbenefits-would-spell-chilling-effects-legal [https://perma.cc/wvx4-46kd]. 62. see, e.g., chris fuchs, driven by fear, green-card holders are avoiding government aid, advocates say, nbc news (dec. 6, 2018, 8:45 am), https://www.nbcnews.com/news/asianamerica/driven-fear-green-card-holders-are-avoiding-government-aid-advocates-n944266 [https://perma.cc/9x27-b936]. 2019] immigration policy and public health 247 may be one result of moving all immigration functions into the department of homeland security after 9/11. the “public charge” rule exposes a larger problem that transcends party politics and the identity of the person occupying the white house. the major conflicts between immigration policy and public health come from two features of american government. the first is structural—federal agencies with different missions. hhs governs the cdc and the u.s. public health service, and it is the liaison between the federal government and state and local health departments. more importantly, hhs is in charge of ensuring that state and local governments are prepared for and can respond to public health emergencies in the united state, through the office of the assistant secretary for preparedness and response (aspr).63 the mission of aspr is “to save lives and protect americans from 21st century health security threats,” including sustaining public health security capacity.64 yet hhs had no input into a dhs rule predicted to have an adverse effect on the containment of contagious disease and the control of epidemics. the second reason for conflict between immigration and public health is federalism. congress decides who can come into the country and under what terms. the federal government controls immigration status and what non-citizens can and cannot do, but states absorb the cost and remain responsible for public health. this is what’s wrong with public health in the u.s. generally, regardless of one’s views on the desirability of immigration. how can we improve this, to ensure state and local health departments have a voice in immigration policy in matters that are vital to public health? iv. immigrant detainees at risk; local health departments on the line i conclude by noting a few other ways in which immigration policy affects public health. public health threats like outbreaks of flu can arise within migrant detention facilities, and when they do, it is the local health department’s responsibility to prescribe measures to prevent further spread. immigration authorities do not reliably contact local health officials when they release migrants who need follow-up for a health condition. other release practices are of concern to health departments because migrants can be placed into situations dangerous to their health and wellbeing if local officials don’t step in. last christmas eve, the u.s. customs and border protection (cbp) released hundreds of recently arrived asylum seekers in downtown el paso with no notice to anyone, leaving aid groups scrambling to find temporary accommodation for them.65 63. u.s. dept. of health & human servs., public health emergency: hhs office of the assistant secretary for preparedness and response, pub. health emergency, https://www.phe. gov/about/aspr/pages/default.aspx [https://perma.cc/6tdd-2qww]. 64. id. 65. sheri fink & caitlin dickerson, border patrol facilities put detainees with medical conditions at risk, n.y. times (mar. 5, 2019), https://www.nytimes.com/2019/03/05/us/borderpatrol-deaths-migrant-children.html [https://perma.cc/3s6e-k7ff]. 248 indiana health law review [vol. 16:235 and we mustn’t forget the health of immigrant detainees held throughout the u.s. recent enforcement policies have threatened health outcomes for migrants in federal custody.66 after the deaths of two children, cbp admitted it was overwhelmed, and dhs hastily arranged for coast guard medical professionals to help with medical screenings for children. immigration authorities have been overwhelmed by a problem they saw coming. consider also the ill-conceived policy that resulted in thousands of children being separated from their parents. local health departments face many challenges in dealing with children who are living together in tent cities, group homes, or detention warehouses. can any child reliably inform anyone of what vaccinations they have had, or of their health history? the inspector general reported in january of this year that there are likely thousands more children than the officially reported number of 2,737.67 the same report noted that the government has lost track of hundreds of children due to poor record keeping, and as a result some may never be reunited with their parents. once again, courts were forced to step-in to a chaotic situation the government itself created, overseeing the reunification efforts and ordering the government to find the children it has apparently lost track of.68 as federal judge dana m. sabraw reminded us, “[t]he hallmark of a civilized society is measured by how it treats its people and those within its borders.”69 from a public health perspective, a nation’s “people” and “those within its borders” are one and the same. as all of these recent examples indicate, the most pressing need now is for better coordination between hhs and dhs on public health and immigration policy. the proposed public charge rule is only the most recent example of the inability of two critically important federal agencies to talk to one another. none of these things require publicly funded health care for impoverished non-citizens, much as public health officials might desire it. none of these things require any change in the current administration’s anti-immigrant policy, either. there are other ways immigration enforcement policy affects population health, but it is not my goal to catalogue these here. in all instances, giving state and local public health officials a seat at the table would result in better policy without sacrificing federal enforcement goals. in the u.s., hhs is supposed to represent state and local health department interests in federal policy made by dhs, but it is unclear that it currently prioritizes that role. 66. id. 67. miriam jordan, family separation may have hit thousands more migrant children than reported, n.y. times (jan. 17, 2019), https://www.nytimes.com/2019/01/17/us/familyseparation-trump-administration-migrants.html?module=inline [https://perma.cc/frv6-pc26]. 68. see richard gonzales, judge says government may have to reunite more migrant families separated at border, nat’l pub. radio (mar. 8, 2019, 11:26 pm), https://www.npr.org/ 2019/03/08/701813103/judge-says-government-may-have-to-reunite-more-migrant-familiesseparated-at-bor [https://perma.cc/z4a8-ytmf]. 69. order granting plaintiffs’ motion to modify class definition at 13, ms. l. v. u.s. immigration & customs enf’t, no. 18cv0428 (s.d. cal. mar. 8, 2019). 2019] immigration policy and public health 249 but congress, too, must find a way to demonstrate that public health is not a partisan issue. mind-numbingly, the most recent congress allowed funding to expire for the pandemic and all-hazards preparedness act, legislation first enacted in 2006 to help prepare the nation for pandemic flu and other public health emergencies. a reauthorization act is pending that would restore funding to help states respond to public health emergencies. may congress take action soon for the safety of all, regardless of where we were born. indiana health law review volume xvi 2019 number 2 notes hoosiers leading the way: prescribing non-opioid controlled substances via telemedicine carah j. austin* “my dear doctor, i’m surprised to hear you say that i am coughing very badly, because i have been practicing all night.” john philpot curran.1 i. introduction a. the issue persistent coughing, high fever, and congestion––these are typical indicators that someone is inflicted with the flu or a similar illness.2 when james, a resident of indiana, was experiencing these symptoms, and therefore in need of a doctor’s opinion and a possible prescription to alleviate his ailments, he did not go the typical route of doing so.3 he did not have to get dressed up or drive the many miles to and from the urgent care and pharmacy.4 he did not have to spend the hours that it would take to see a provider and get his prescription.5 in fact, james did not even have to leave his home.6 instead, james turned on his computer in the comfort of his own home and called a local doctor through the innovative service that is telemedicine.7 the creation of internet services, such as skype, facetime, and google hangouts, allow people to converse as if in person but without having to actually be in the same proximity.8 while this type of communication is great for college students wanting to see their parents or pets back home, the foundational basics * j.d. & m.h.a. candidate, 2020, indiana university robert h. mckinney school of law; b.s., 2016, butler university. 1. des machale, wit 162 (2003). 2. do you have a cold or flu?, webmd, https://www.webmd.com/cold-and-flu/fluguide/is-it-cold-flu [https://perma.cc/c2hd-anhc]. 3. interview with james rochester, resident, camby, ind. (dec. 20, 2017). 4. id. 5. id. 6. id. 7. id. 8. see lewis wake, skype vs facetime vs google hangouts, univ. st. andrews (sept. 26, 2016), https://digitalcommunications.wp.st-andrews.ac.uk/2016/09/26/skype-vs-facetime-vsgoogle-hangouts/ [https://perma.cc/ps79-g2pv]. 300 indiana health law review [vol. 16:299 behind video-communications programs have great implications in the everevolving and technology-dependent world of health care. in fact, popping up across indiana recently are billboards and radio ads promoting this fairly modern method of health care delivery—the same advancement in health care delivery that james used to combat his cold: telemedicine. many major indiana providers have recently been swapping out in-person patient visits with videoconferencing. indiana hospital networks, such as franciscan health (“franciscan”),9 indiana university health (“iu health”),10 and community health network (“chn”),11 have rolled out their own versions of a convenient virtual office visit. this note will use these three providers as the basis for the following case study on indiana telehealth services. for most networks, telemedicine is as simple as creating a patient account online or registering via the provider’s telehealth app, completing the patient’s medical history, and scheduling a virtual care visit.12 with the ever-changing field of health care now expanding into telemedicine services, it is more important than ever for lawmakers to consider the importance of a health care provider’s ability to legally prescribe medications to their online patients so as to treat them as effectively as possible. the indiana code, for example, has been amended twice (in 2016 and 2017) to lessen the restrictions on physicians’ online prescribing abilities.13 this is good news for indiana providers and patients alike. as will be discussed in this note, telemedicine results in decreased cost and increased access to health care services, and with better access to their “toolkit” (i.e., prescription medications), indiana telehealth providers will be able to more efficiently and effectively treat their patients. many non-opioid controlled substances are an effective tool in treating illness and the option to prescribe these substances should be available to telemedicine providers. although in light of the recent opioid epidemic physicians need to be vigilant about their prescription of opioids, a middle ground needs to be paved so that telemedicine providers can recommend the best treatment option for their virtual patients. this note will argue that indiana’s recent changes to its telemedicine prescribing laws allow providers the toolkit necessary to treat their telemedicine patients. this note will also suggest that indiana’s updated telemedicine prescribing laws provide a respectable middle ground between provider autonomy and the regulation of controlled substances. this note recommends that the recent changes in indiana’s telemedicine prescribing laws should be mirrored by other states. 9. telehealth, franciscan health, https://www.franciscanhealth.org/health-careservices/telehealth-377 [https://perma.cc/c25b-6wn6]. 10. iu health video visits, ind. u. health, http://iuhealth.org/videovisitsapp/ [https://perma.cc/9kp5-9vtt]. 11. community virtual care, mdlive, https://members.mdlive.com/ecommunity/landing_ home [https://perma.cc/t9xj-nxvg]. 12. id. 13. it is possible that the indiana code will continue to be amended in coming years to further address the technological changes in medicine delivery. 2019] hoosiers leading the way 301 b. roadmap this note will first provide a 30,000-foot overview of the united states (“u.s.”) health care system, focusing specifically on the cost of and access to health care services. section ii will discuss the background, various definitions, and history of telemedicine. it will also explore the types of providers and consumers of telemedicine, health issues that can be addressed by telemedicine, and the hipaa and cybersecurity issues involved with providing medical treatment virtually. finally, section ii will look at the positive impacts of telemedicine on the health care system, focusing specifically on decreased cost to the system and the provider and increased access to health services. next, section iii will examine the medical standard of care and analyze cases in which providers toed the line of what was and was not allowed in online prescribing. particularly, controlled substances and opioids will be the focus. this section will then explore the regulation of telemedicine prescribing practices by entities such as individual telemedicine providing organizations, the american medical association (“ama”), federal regulations, and state regulations. additionally, section iii will look at the recent changes that have been made to indiana’s telemedicine prescribing laws, particularly house enrolled act 1263 in 2016, and house enrolled act 1337 in 2017. indiana’s laws will then be compared to other states’ telemedicine prescribing laws in terms of restrictiveness. finally, in section iv, this note will conclude that hospitals offering telemedicine services will increase access to care for their served communities and will decrease their expenditures on health care services (primarily for urgent/primary care). it will be suggested that indiana is leading the way in telemedicine prescription laws and other states should amend their regulations to be in line with indiana. additionally, it will be recommended that individual providers and the ama should also amend their guidelines to catch up with recent legislation while also offering providers a clear guideline of the standard of care that. ii. u.s. health care access and cost as it relates to telemedicine a. 30,000-foot overview of the u.s. health care system the golden rule of health care in our society is that everyone deserves the finest health care attainable, provided someone else pays. but in what i call the iron triangle of health care, access, quality, and cost containment have equal angles, representing identical priorities, and an expansion of any one angle compromises one or both of the other two. all societies confront the equal tensions among access to health services, quality of health care, and cost containment. tradeoffs are inevitable regardless of the size of the triangle. call them resource allocation or rationing, they 302 indiana health law review [vol. 16:299 are choices our society must make.14 the major aims of the affordable care act (“aca”) were to address two sides of the iron triangle: make health care more affordable and improve access to health care.15 telemedicine works to not only lower the cost of ambulatory and long-term health care, but to also increase access to care. while the aca implemented telemedicine coverage at the federal level through medicare, it mainly left the decision of what telemedicine services would be covered under medicare to the states.16 first, to understand the impact that telemedicine has on health care cost and access, a brief overview of the current fiscal and access conditions in american health care is necessary. 1. cost in 2015, the u.s. spent $3.2 trillion (roughly $9,990 per person) on health care.17 this is an astonishing amount compared to other developed countries. for example, in 2014, canada spent only $4,506 per person on health care with the united kingdom spending a mere $3,971 per person.18 additionally, in the u.s., spending on physician and clinical services increased by 6.3% between 2014 and 2015, and spending for hospital care increased by 5.6%.19 national health expenditure accounted for 17.8% of the gross domestic product in 2015 in the u.s.,20 while health expenditure only accounted for 10.4% in canada and 9.1% in the united kingdom.21 while the u.s. far outspends its counterparts in terms of health care, where does indiana stand within the u.s.’ extreme spending habits? indiana ranks as the 15th highest spender on health care services, spending 14. william l. kissick, medicine’s dilemmas: infinite needs versus finite resources 2 (1994). 15. see access to quality, affordable health care: progress and promise of the affordable care act and other administration efforts, white house, (oct. 20, 2016), https:// obamawhitehouse.archives.gov/the-press-office/2016/10/20/access-quality-affordable-health-careprogress-and-promise-affordable [https://perma.cc/wbq3-cf6a]. 16. y. tony yang, telehealth parity laws, health aff., (aug. 15, 2016) https://www. healthaffairs.org/do/10.1377/hpb20160815.244795/full/ [https://perma.cc/sbr9-a2bz]. 17. national health expenditures 2015 highlights, ctrs. for medicare & medicaid services, https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andreports/nationalhealthexpenddata/downloads/highlights.pdf, [https://perma.cc/t3z7-ku8r]. 18. united states per capita healthcare spending is more than twice the average of other developed countries, peter g. peterson found. (2016), https://www.pgpf.org/sites/default/ files/0006_health-care-oecd.pdf [https://perma.cc/pp76-nalx]. 19. national health expenditures 2015 highlights, supra note 17. 20. id. 21. health expenditure, total (% gdp), world health org. global health expenditure, https://data.worldbank.org/indicator/sh.xpd.totl.zs [https://perma.cc/4txlz9ht]. 2019] hoosiers leading the way 303 roughly $54 billion on health care services in 2014,22 and spending $8,300 per capita on health care costs, a category in which the hoosier state ranks 22nd.23 indiana also ranks 16th in terms of the average annual percent growth in health care expenditure between 1991 and 2014, at 5.3% per year.24 although indiana is not as much to blame for the country’s massive health care expenditure as the number one per capita spender––the district of columbia at $11,944 per person––improving the costs associated with the health care system is always possible.25 2. access according to the institute of medicine, access to health services means “the timely use of personal health services to achieve the best health outcomes.”26 access to health services is important because it impacts an individual’s overall physical, social, and mental health status and quality of life.27 unfortunately, there are still many barriers to accessing health services in the u.s.28 some of these barriers include high cost of care, inadequate or no insurance coverage, lack of availability of services, and lack of culturally competent care.29 these barriers ultimately lead to unmet health needs, delays in receiving appropriate care, inability to receive preventive services, financial burdens, and avoidable hospitalizations.30 a particular barrier that the u.s. struggles with is its physicians per capita. in 2015, the u.s. had an average of just 2.5 physicians per 100,000 people, whereas other developed countries, such as germany (4.0) and greece (6.2), far outranked the u.s.31 indiana struggles with this barrier as well. in 2015, indiana 22. health care expenditures by state of residence (in millions), kaiser fam. found., https://www.kff.org/other/state-indicator/health-care-expenditures-by-state-of-residence-inmillions/ [https://perma.cc/gw7c-3h8e]. 23. health care expenditures per capita by state of residence, kaiser fam. found., https://www.kff.org/other/state-indicator/health-spending-per-capita/?currenttimeframe= 0&sortmodel=%7b%22colid%22:%22health%20spending%20per%20capita%22,%22sort%2 2:%22desc%22%7d [https://perma.cc/rr2h-qw2m]. 24. average annual percent growth in health care expenditures per capita by state of residence, kaiser fam. found., https://www.kff.org/other/state-indicator/avg-annual-growthper -cap it a /?cu r ren t t im ef ram e= 0 &sor tmode l= % 7 b % 2 2 colid% 2 2 :%2 2 avg.% 20annual%20%25%20growth%20per%20capita%22,%22sort%22:%22desc%22%7d [https://perma.cc/rf4k-my6q]. 25. health care expenditures by state of residence (in millions), supra note 22. 26. inst. of med., access to health care in america (michael millman ed., 1993). 27. id. 28. id. 29. id. 30. id. 31. merritt hawkins, the physician shortage: data points and state rankings 9 (2015). 304 indiana health law review [vol. 16:299 ranked 36 in the country with 205.7 physicians per 100,000 people.32 comparatively, the number one ranked state, massachusetts, maintains a rate of 349.5 physicians per 100,000 patients.33 indiana also ranked 37 in the category of primary care physicians per 100,000 people with 74.1 doctors.34 not surprisingly, as a result 77.8% of indiana physicians reported being at capacity or overextended.35 specifically, access to health care in rural settings is a significant barrier in indiana. access to physicians across indiana is inequitably distributed, mainly due to poor performance in recruitment and retention of active providers in rural areas.36 in the u.s., only 9% of physicians practice in rural areas despite 20% of the population residing in rural settings and 60% of indiana counties resting in rural or non-metropolitan areas.37 in 2012, marion county, an urban community,38 was rated as the top indiana county in terms of physician access.39 in contrast, counties with a more rural make-up, such as posey and switzerland county,40 were rated as having the worst access to physician care.41 this is primarily due to the shortage of health professionals in rural communities.42 in 2015, urban communities, on average, were found to have a rate of 70 primary care physicians, 60 dentists, 184 mental health providers, and 1,040 registered nurses per 100,000 people.43 rural areas, however, were found to have a rate of only 43 doctors, 31 dentists, 55 mental health providers, and 453 registered nurses per 100,000 residents.44 as the u.s., including indiana, faces health care issues such as cost of care 32. id. at 3. 33. id. 34. id. at 5. 35. id. at 14. 36. affiliated serv. providers of ind., inc., indiana state rural health plan (2012), https://www.in.gov/isdh/files/indiana_state_rural_health_plan_2012.pdf [https://perma.cc/976j-lw83]. 37. nat’l rural health ass’n, recruitment and retention of a quality health work force in rural areas (nov. 2006), https://www.ruralhealthweb.org/getattachment/advocate/policydocuments/rr6publichlth.pdf.aspx?lang=en-us [https://perma.cc/4hmv-usxs]. 38. in july 2016, the population of marion county, indiana was estimated to be 941,229 people. quickfacts, u.s. census bureau, https://www.census.gov/quickfacts/fact/map/ marioncountyindiana/pst045216#viewtop. 39. affiliated serv. providers of ind., inc., supra note 36. 40. in july 2016, the population of posey county and switzerland county, indiana were estimated to be 25,476 and 10,527 respectively. quickfacts, u.s. census bureau (last visited feb. 19, 2018), https://www.census.gov/quickfacts/fact/map/marioncountyindiana/pst045216#viewtop. 41. affiliated serv. providers of ind., inc., supra note 36. 42. id. 43. ind. univ. pub. policy inst., hoosier health and access to care, (2015), http://policyinstitute.iu.edu/uploads/publicationfiles/hoosier%20health_thriving__web.pdf [https://perma.cc/6grx-aev5]. 44. id. 2019] hoosiers leading the way 305 and access to care, health care providers have begun to use advances in social technology to provide health care in an easier and more efficient manner. b. telemedicine background 1. telemedicine defined telemedicine has been given a variety of definitions, from layman terms used by the everyday patient to organizational definitions provided by health care organizations to the definition in statutes created by legislatures. according to the american telemedicine association (“ata”), “[t]elemedicine is the remote delivery of health care services and clinical information using telecommunications technology. this includes a wide array of clinical services using internet, wireless, satellite and telephone media.”45 while some organizations provide distinctive descriptions for each word, “ata treats ‘telemedicine’ and ‘telehealth’ as synonyms and uses the terms interchangeably.”46 both terms have the synonymous meaning of delivering clinical services remotely through health care technology.47 the u.s. code defines the practice of telemedicine as the practice of medicine in accordance with applicable federal and state laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system.48 most important to the substance of this note, the indiana code defines telemedicine as the delivery of health care services using electronic communications and information technology, including: (1) secure videoconferencing; (2) interactive audio-using store and forward technology; or (3) remote patient monitoring technology; between a provider in one (1) location and a patient in another location.49 it is also important to note that the indiana legislature does not include in the term the following: (1) audio-only communication; (2) a telephone call; (3) electronic mail; (4) an instant messaging conversation; (5) facsimile; (6) internet questionnaire; (7) telephone consultation; or (8) internet consultation.50 45. about telemedicine, am. telemedicine ass’n, http://www.americantelemed.org/ about/telehealth-faqs[https://perma.cc/7vk3-l7zt]. 46. id. as the ata treats telemedicine and telehealth as one in the same, and indiana statutory language does not specify a difference either, this note will use the two terms synonymously. 47. id. 48. 21 u.s.c.s. § 802 (54) (2017). 49. ind. code § 25-1-9.5-6 (2016). 50. ind. code § 25-1-9.5-6 (2016). 306 indiana health law review [vol. 16:299 2. history the rudimentary idea behind telemedicine—delivering health care information across some sort of continuum—reaches back to ancient greece and rome.51 many communication mechanisms, including smoke signals and light reflections, were used to communicate medical information, such as the outbreak of a plague and notifications of births and deaths.52 modern telemedicine began with the invention of the telegraph and telephone, which brought long distance communication to the public.53 in april 1924, an issue of radio news magazine published an image of a patient and a physician using a monitor and a microphone for means of communicating about the heartbeat and temperature of the patient.54 although this was merely an image of the imagination at the time, the idea of transmitting medical information via non-face-to-face methods was gaining traction.55 in the 1950s and 1960s, the university of nebraska used the concept of telemedicine to conduct neurological examinations using medical data such as fluoroscopy images, x-rays, and electrocardiograms.56 one of the university’s motivations in conducting telemedicine services was to provide access to health care in rural areas.57 the rise of the internet in the 1990s brought along the basis for telemedicine as we know it today.58 the internet allowed providers to deliver patient education, view medical images, conduct real-time audio and video consultations, and measure vital signs all via the internet.59 today, as will be discussed further in this note, patients and providers have a plethora of technological services available to receive and provide medical care, such as smartphone cameras, vital sign monitoring devices, digital stethoscopes, and so on.60 3. prescribers indiana telemedicine laws define prescribers as any of the following: (1) a physician licensed under ic 25-22.5; (2) a physician assistant licensed under ic 25-27.5 and granted the authority to prescribe by the physician assistant’s supervisory physician in accordance with ic 25-27.5-5-4; 51. history of telemedicine, mdportal, http://mdportal.com/education/history-oftelemedicine/ [https://perma.cc/7xxf-35nw]. 52. id. 53. id. 54. id. 55. id. 56. id. 57. id. 58. id. 59. id. 60. id. 2019] hoosiers leading the way 307 (3) an advanced practice nurse licensed and granted the authority to prescribe drugs under ic 25-23; (4) an optometrist licensed under ic 25-24; and (5) a podiatrist licensed under ic 25-29.61 under indiana law, those certified in the above professions in the state of indiana can provide a medical consultation and prescription if warranted through a telemedicine service. three of indiana’s major health care providers, franciscan, iu health, and chn, provide some form of telemedicine service.62 chn, although located in indiana, provides telehealth services that are available anywhere in the u.s. with a few state specific exceptions.63 chn’s providers are all u.s. board certified and fully licensed to practice medicine in the state the patient is located.64 to ensure that chn providers are meeting their patients’ needs, patients are given a survey to evaluate their providers and appointments.65 chn analyzes and reviews the results for quality assurance and uses them as part of their continuous improvement process.66 “selected provider consultations are also reviewed by [their] internal medical board.”67 likewise, iu health has expanded their access to health care through its telemedicine program, “video visits”, which provides services to anyone in indiana.68 when using iu health’s services, a patient will connect “with a highly skilled iu health or iu health affiliated physician.”69 similarly, patients will meet with a board-certified franciscan health physician via the internet, if choosing to go through franciscan to receive telemedicine services.70 in short, in order to provide telemedicine services a provider must fall into one of the categories as described by the indiana code. the three indiana telemedicine services that this note analyzes all ensure that their providers are licensed to practice medicine in the state of indiana. 61. ind. code § 25-1-9.5-4 (2017). 62. while this is not an exhaustive list of providers that offer telemedicine services to indiana residents, this note will use these three providers to give an overview of typical telemedicine practices. 63. community virtual care frequently asked questions, mdlive, https://members. mdlive.com/ecommunity/how_it_works [https://perma.cc/37ur-pm2m]. community health network does not specific any exceptions for patients residing in indiana. 64. id. 65. id. 66. id. 67. id. 68. iu health expands access to health care with video visits, hendricks county flyer, http://www.flyergroup.com/news/local_news/iu-health-expands-access-to-health-care-with-videovisits/article_98fafb22-ba80-510a-9874-6fe2144e5751.html [https://perma.cc/hqn5-rchp]. 69. id. 70. franciscan on demand, franciscan health, https://www.franciscanhealth.org/ franciscanondemand [https://perma.cc/sbm7-82k4]. 308 indiana health law review [vol. 16:299 4. consumers typically, any patient who would be able to utilize an urgent care facility to receive treatment can use a telemedicine service. adults and children two-years and older in indiana can see a provider via the iu health video visits71 while franciscan health allows anyone twelve-years and older to conduct a virtual visit.72 5. health issues addressed most organizations offering telemedicine services have 24/7 availability for patients to discuss with a provider common conditions that one would usually go to an urgent care facility to treat.73 conditions commonly treated by telehealth services include colds, minor rashes, allergies, flu, headache, insect bites, respiratory problems, and acne.74 in addition to urgent care situations, telehealth is also used for scheduled visits in which a patient can talk with a provider about more long-term illnesses and conditions, such as weight management, depression, dermatology, and diabetes.75 telehealth also seeks to reduce some of the inefficiencies of home health care in various ways, including replacing certain nursing visits with video appointments, collecting vital-signs data remotely, and improving medication compliance and patient education. the use of telehealth in home health care settings will provide a means of interacting in a patient-centered manner, promoting patient autonomy through education, and improving communication. one of the substantial benefits stemming from telehealth services is the access to prescriptions without having to worry about the traffic, time, and money associated with visiting a doctor in person. providers via iu health’s video visits, for example, can send a prescription directly to a patient’s pharmacy of choice. however, these providers do not prescribe controlled substances.76 similarly, if a chn telemedicine provider believes medication is necessary, a prescription for a non-controlled substance can be sent electronically to over 65,000 pharmacies.77 the latter part of this note will further address the access to and regulation of prescription drugs via telemedicine services in indiana. 71. iu health video visits frequently asked questions, ind. u. health, http://iuhealth.org/ videovisitsfaqs/ [https://perma.cc/5sgg-pucl]. 72. franciscan on demand, supra note 70. 73. iu health video visits, supra note 10. 74. franciscan on demand, supra note 70; community virtual care frequently asked questions, supra note 63. 75. iu health video visits, supra note 10. 76. iu health video visits frequently asked questions, supra note 71; see drug schedules 1-5, ind. state dep’t health, https://www.in.gov/isdh/27380.htm [https://perma.cc/sg56-442v] (listing controlled substances in indiana). 77. community virtual care frequently asked questions, supra note 63. 2019] hoosiers leading the way 309 6. hipaa and security just as with any health services provided in-person, health insurance portability and accountability act (“hipaa”) guidelines are binding on medical providers who practice via telemedicine and provide services in the home of the patient.78 providers must keep in mind that the channel of communication used for communicating electronic protected health information (“ephi”) at a distance is also important in complying with hipaa guidelines.79 the hipaa guidelines on telemedicine state: “(1) only authorized users should have access to ephi; (2) a system of secure communication should be implemented to protect the integrity of ephi; and (3) a system of monitoring communications containing ephi should be implemented to prevent accidental or malicious breaches.”80 specific policy language varies by organization, but all must ensure, at the least, to meet patient privacy laws. for example, chn assures that community virtual care is safe and private.81 chn’s telemedicine services are compliant with hipaa and patient information will only be shared with the selected provider and pharmacy.82 iu health also assures its patients that their “medical information and video connection are secured with end-to-end 128-bit encryption per the national institute of standards and technology’s security requirements for cryptographic modules.”83 c. telemedicine as a positive development in health care technology while there are still improvements that need to be made in order for telemedicine’s effect to be as far reaching as possible, some of the benefits telemedicine can provide to the u.s. are already visible.84 1. cost a. cost to consumer one major advantage for patients in using telehealth services is the cost. 78. hipaa guidelines on telemedicine, hipaa j., https://www.hipaajournal.com/hipaaguidelines-on-telemedicine/ [https://perma.cc/8xer-by95]. 79. id. ephi includes patient names, social security numbers, photographs, and payment information. margaret rouse, electronic protected health information (ephi), techtarget, http://searchhealthit.techtarget.com/definition/electronic-protected-health-information-ephi [https://perma.cc/f5vy-rsxm]. 80. hipaa guidelines on telemedicine, supra note 78. 81. community virtual care frequently asked questions, supra note 63. 82. id. 83. iu health video visits frequently asked questions, supra note 71. 84. bill frist, telemedicine: a solution to address the problems of cost, access, and quality health aff. (july 23, 2015), http://www.healthaffairs.org/do/10.1377/hblog20150723.049490/full/ [https://perma.cc/99ve-2f46]. 310 indiana health law review [vol. 16:299 insurance coverage will ultimately determine what out-of-pocket cost the patient will be responsible for, but visits typically cost a flat, low rate as little as $40.85 iu health and franciscan health, for example, each charge $49, less than the typical urgent care visit.86 this is a major savings to the consumer considering the average urgent care visit is $156.87 additionally, the patient saves the cost of transportation and travel time that it takes to visit a provider in person. telehealth services can allow patients to receive hospital services at home, further cutting costs. franciscan health’s telehealth program, akin to their on demand virtual visits,88 is a web-based program that allows providers to monitor patients’ care through the comfort of the patients’ own home.89 patients are given take-home equipment that allows providers to remotely monitor vital signs and gather other information that is securely sent to each patient’s care team.90 this program specifically focuses on patients with chronic conditions, such as congestive heart failure, multiple emergency room visits and frequent hospitalizations, or complex medication regimens.91 in baltimore, results from johns hopkins hospital’s application of the hospital at home program92 showed the total cost of at-home care was 32% less than traditional hospital care ($5,081 vs. $7,480), the mean length of stay for patients was shorter by one-third (3.2 days vs. 4.9 days), and the incidence of delirium (among other complications) was dramatically lower (9% vs 24%).93 with a similar study of the hospital at home program at presbyterian health care service in albuquerque, spending was 19% lower using this model than the typical inpatient care for similar conditions.94 85. id. 86. iu health video visits frequently asked questions, supra note 71; community virtual care frequently asked questions, supra note 63. 87. comparing costs and quality of care at retail clinics with that of other medical settings for 3 common illnesses, annals internal med., http://annals.org/aim/fullarticle/ 7 4 4 702/compar in g-cos t s -q u a li t y-ca re -r e t a i l-c lin ics -o th e r -m edica l-se t t in gs -3 [https://perma.cc/nn9h-6mr4]. 88. while this note uses telemedicine and telehealth synonymously, in this instance franciscan health differentiates the two terms. franciscan’s telehealth program provides at-home long-term monitoring via the internet while franciscan’s on demand virtual visits, referred to as telemedicine here, provides urgent care-like visits via the internet. supra, note 69. 89. telehealth, supra note 9. 90. id. 91. id. 92. the hospital at home program provides hospital-level care to a patient in their own home as a substitute for acute hospital care. the program was developed at johns hopkins schools of medicine and public health. about hospital at home, hosp. home, http://www. hospitalathome.org/about-us/overview.php [https://perma.cc/b6j5-hete]. 93. telehealth: helping hospitals deliver cost-effective care, am. hosp. ass’n (2016), http://www.aha.org/content/16/16telehealthissuebrief.pdf [https://perma.cc/2xvj-76qw]. 94. id. 2019] hoosiers leading the way 311 b. cost to system while hospital expenditures to start telemedicine services differ slightly depending on the exact process the organization decides to follow, the costs for startup are relatively low and can be tailored to meet the provider’s goals.95 allinclusive telemedicine systems range between $20,000 and $28,000 and include “the telemedicine software, primary care medical devices, and the mobile cart/case”.96 however, policymakers have expressed concern regarding the potential overutilization of telehealth services as they become more accessible.97 legislators contend that easier access to health care services will increase utilization by consumers and therefore result in additional expenses for programs such as medicaid and medicare as more recipients will take advantage of the easy-to-access health care services.98 however, studies suggest that these fears are unfounded.99 in fact, studies propose that medicare should actually see a decrease in health care costs as the use of telemedicine (as opposed to traditional services) increases.100 for example, the general cost for a telehealth visit is substantially lower than that of a traditional in-person acute care visit. telehealth visits typically range from $40 to $50 while an in-person visit can range from $136 to $176.101 in states that reimburse telehealth visits at the same rate as in-person visits, medicare could save an estimated $45 per visit.102 similarly, medicare can save on patients needing long-term care, if the patients enroll in a hospital at home program, due to the substantially less amount of time the patient needs care.103 as previously mentioned, patients enrolled in a hospital at home program typically require a mean length of stay that is one-third shorter than that of patients in the hospital104 and 3.5 days in johns hopkins hospital at home program, as compared to 5.4 for inpatient admissions.105 95. i want to “do telemedicine”: what is involved and how much does it cost?, amd global telemedicine, (july 9, 2015), https://www.amdtelemedicine.com/blog/article/i-want-dotelemedicine-what-involved-and-how-much-does-it-cost [https://perma.cc/3ph3-man4]. 96. id. 97. telehealth: helping hospitals deliver cost-effective care, supra note 93. 98. id.; see also najilla nassery et al., systematic overuse of healthcare services: a conceptual model, 13 applied health economics and health policy 1 (2015). 99. telehealth: helping hospitals deliver cost-effective care, supra note 93. 100. dale h. yamamoto, assessment of the feasibility and cost of replacing in-person care with acute care telehealth services, alliance for connected care (2014). 101. id. 102. id. 103. about hospital at home, supra note 92. 104. id. 105. vida foubister, hospital at home program in new mexico improves care quality and patient satisfaction while reducing care, commonwealth fund. (sep. 2011), http://www. commonwealthfund.org/publications/newsletters/quality-matters/2011/august-september-2011/case312 indiana health law review [vol. 16:299 another area that demonstrates the cost-cutting benefits of telemedicine is that of required follow-up visits. a majority of diagnoses made during an initial telehealth visit can be resolved in that same visit.106 when telehealth is used for an initial visit (instead of the emergency department or the physician’s office), only 6% of patients require a follow-up, whereas 13% of in-person doctor office visits and 20% of emergency department visits for similar conditions require follow-up visits.107 2. access telemedicine provides twenty-four-hour access to a health care provider from any location so long as it is permitted under state law.108 using telehealth to provide specialty services may be more feasible for rural health care facilities than staffing the facilities with their own specialist providers.109 several types of services administered through telehealth technology have been used effectively in rural communities for a wide variety of patient care; examples include: chronic care management interventions, emergency care, home monitoring, intensive care units, long-term care, online therapy, and remote counseling.110 students in southwestern jefferson county schools, located in southern indiana, used to make a twenty-five minute drive to see the nearest doctor. in january 2017, as part of the telehealth initiative by the indiana rural health association, the school installed two virtual clinics where students can now simply walk down the hallway and connect with a physician via video.111 iu health transplant offers several clinics in which patients can have their post-surgery follow-up appointments with a doctor in indianapolis via telemedicine. for mick bonner, who received a kidney transplant, telemedicine was a life-saver. being from michigan city, yet seeing doctors in indianapolis, bonner had to make a six hour round trip each time he had a check-up. iu health’s clinic in gary allowed bonner to visit with his doctors in indianapolis via video chat.112 study [https://perma.cc/cm7s-vm7z]. 106. id. 107. telehealth: helping hospitals deliver cost-effective care, supra note 93. 108. frist, supra note 84. 109. see i want to “do telemedicine”: what is involved and how much does it cost?, supra note 95 (demonstrating the ability to add medical devices, such as a digital stethoscope, for conducting specialized telemedicine services); see also ind. univ. pub. policy inst., supra note 43 (showing the shortage of health care providers in rural indiana). 110. telehealth use in rural healthcare, rural health info. hub, https://www.ruralhealthinfo.org/topics/telehealth [https://perma.cc/n5kr-6ng3]. 111. carson gerber, telehealth clinics boost rural access across indiana, indiana economic digest (may 27, 2017, 8:09 am), http://www.indianaeconomicdigest.net/ main.asp?sectionid=31&subsectionid=135&articleid=88202 [https://perma.cc/4mfr-fkwj]. 112. kathleen quilligan, iu health opens telemedicine outreach clinic in gary, (sept. 2, 2011), nwi.com, http://www.nwitimes.com/news/local/lake/gary/iu-health-opens-telemedicine2019] hoosiers leading the way 313 visiting again the concept of the hospital at home telehealth program, such as the one practiced by franciscan health, patients are provided a much more convenient means of health care, particularly for those who are facing chronic conditions.113 providers and patients alike may be concerned with the effectiveness of treatment in the home setting. however, a study of the hospital at home program at johns hopkins medicine found no difference in rates of subsequent use of medical services or readmissions, and patient and family member satisfaction was higher in the home setting than among those offered inpatient hospital care.114 recent federal legislative actions have attempted to further increase the access to health care through telemedicine. four bills before the 115th congress held protentional for having a positive impact on the future of telehealth. the creating opportunities now for necessary and effective care technologies for health act (“connect”) and the creating high-quality results and outcomes necessary to improve chronic care act of 2016 (“chronic”) aimed to widen the scope of medicare reimbursement for telehealth services, including the treatment of chronic medical conditions via telehealth-delivered services.115 additionally, house resolution 766 focused on medicare patients by looking to implement a telehealth program for those medicare patients who live in public housing.116 finally, the furthering access to stroke telemedicine act (“fast”) aimed to increase medicare recipients’ access to telestroke resources.117 however, none of the bills were signed into law.118 iii. breach of the standard of care and the regulation of telemedicine prescribing practices a. standard of care and medical malpractice in online prescribing with the increase in telemedicine prescribing comes the need for providers and private regulators to be more vigilant than ever in assuring that their prescription practices are not in violation of federal or state laws. law makers use outreach-clin ic-in -gary/art icle_6d9b14 c2 -9 cb7 -5 6 6 9 -b4 9 e-1cb04e7325f6 .h tml [https://perma.cc/6mcf-2yx4]. 113. telehealth, supra note 9. 114. sarah klein, “hospital at home” programs improve outcomes, lower costs but face resistance from providers and payers, commonwealth fund. (sept. 2011), http://www. commonwealthfund.org/publications/newsletters/quality-matters/2011/august-september-2011/infocus [https://perma.cc/pum2-ds2l]. 115. lauren cranford, what the american health care act might mean for telemedicine, chiron health (may 8, 2017), https://chironhealth.com/blog/american-health-care-act-mightmean-telemedicine/ [https://perma.cc/39vt-umzp]. 116. id. 117. id. 118. s. res. 1016, 115th cong. (2017-2018); s. res. 870, 115th cong. (2017-2018); h.r. res. 766, 115th cong. (2017-2018); h.r. res. 1148, 115th cong. (2017-2018). 314 indiana health law review [vol. 16:299 the “standard of care” to furnish providers with a guideline as to what is minimally expected of them throughout their care of patients. while the medical community does not provide a general definition for the standard of care, the term is firmly defined by law as “the caution that a reasonable person in similar circumstances would exercise in providing care to a patient.”119 the legal definition of standard of care and what is and is not allowed in prescribing to patients via the internet is clear; thus, it should typically be clear if a provider has broken the law through their actions whilst prescribing to patients. a brief case law analysis clarifies the circumstances that have constituted violation of the legal standard of care by providers in the treatment of a patient and subsequent provision of a prescription. in particular, there are many examples to draw upon in which providers, typically physicians, have been sanctioned by a state medical board for the unethical and sometimes unlawful prescription of medications. in one such case, ancier v. department health medical quality assurance commission, a physician, dr. ancier, prescribed medications to patients via the internet.120 he was affiliated with an internet-based company offering prescription medication to customers without existing prescriptions.121 in order to acquire a prescription, a patient visited the company’s website, completed a questionnaire, attested to having undergone a recent physical examination, and affirmed he or she would schedule future routine physicals while on the medication.122 a patient also agreed to “consult local physicians or pharmacists about any adverse reactions or complications.”123 a provider then reviewed the application and decided whether or not to issue the prescription.124 doctors were paid for each application they reviewed, regardless of whether the prescription was granted.125 dr. ancier reviewed approximately 200,000 requests and issued 180,000 prescriptions between 2001 and 2004, despite not physically examining or personally interviewing any of the persons receiving these prescriptions.126 the washington medical quality assurance commission found that two of dr. ancier’s patients were placed at unreasonable risk of harm through this process.127 thus, the commission revoked his license to practice medicine.128 similarly, in portales v. kentucky board of medical licensure, a formal complaint was issued in may 2001, by the kentucky board of medical 119. dirk c. strauss & j. meirion thomas, what does the medical profession mean by “standard of care?”, 27 j. clinical oncology 192, 192 (2009). 120. ancier v. dep’t of health, med. quality assurance comm’n, 166 p.3d 829 (wash. ct. app. 2007). 121. id. 122. id. 123. id. 124. id. 125. id. 126. id. 127. id. 128. id. 2019] hoosiers leading the way 315 licensure.129 dr. portales was involved in prescribing medications over the internet without prior consultations with patients.130 this was found to be in violation of the kentucky medical practice act.131 the court of appeals of kentucky affirmed the kentucky board of medical licensure’s decision to revoke dr. portales’ medical license.132 in thompson v. state board of registration for the healing arts, defendant dr. thompson reviewed a request form for weight loss medication submitted by an undercover agent over the internet.133 dr. thompson issued the prescription without ever examining the “patient” or confirming the information in the online form.134 consequently, the administrative hearing committee found that dr. thompson prescribed a controlled substance without a sufficient medical examination in violation of missouri revised statute § 334.100.2(4)(h).135 on appeal, the missouri court of appeals found that dr. thompson was not disciplined for the act of prescribing medication over the internet, contrary to what he claimed, but rather for prescribing medicine to the undercover agent without performing a sufficient examination.136 in golob v. arizona medical board, the arizona court of appeals found that a physician deviated from the requisite standard of care when she failed to conduct physical examinations of her patients and failed to establish a physicianpatient relationship.137 the court determined that she created a potential harm to persons to whom she prescribed medication without physically examining them to ensure they did not have more serious medical conditions.138 prescription medication, including controlled substances, are at times essential to the effective treatment of a patient and telemedicine prescribing allows providers to treat their patients even more efficiently. however, as demonstrated with the above cases, physicians are placed in a high state of risk of violating state laws when prescribing online as there are additional requirements imposed on them as compared to simply prescribing in-person. in particular, there are additional regulations concerning the prescription of controlled substances, including opioids, through telemedicine. 129. portales v. ky. bd. of med. licensure, no. 2007-ca-001060-mr, 2008 ky. app. unpub. lexis 654 (ct. app. nov. 21, 2008). 130. id. 131. ky. rev. stat. § 311.530, et seq. 132. portales v. ky. bd. of med. licensure, supra note 127. 133. thompson v. state bd. of registration for the healing arts, 244 s.w.3d 180 (mo. ct. app. 2007). 134. id. 135. id. 136. id. 137. golob v. ariz. med. bd., 176 p.3d 703 (ariz. ct. app. 2008). 138. id. 316 indiana health law review [vol. 16:299 b. controlled substances and opioids the controlled substances act (“csa”) classifies controlled substances and divides them into five schedules.139 the code of federal regulations140 publishes an updated list annually of the substances that are considered to be controlled and into what schedule they fall.141 substances are placed into their respective schedules based on whether they have a currently accepted medical use in the u.s., their relative abuse potential, and likelihood of causing dependence when abused.142 schedule i controlled substances have no accepted medical use in the u.s., a lack of accepted safety for use under medical supervision, and a high potential for abuse.143 schedule i substances include heroin, lsd, marijuana, and ecstasy.144 schedule ii controlled substances have a high potential for abuse that may lead to sever psychological or physical dependence.145 common schedule ii substances include hydromorphone, methadone, oxycodone, amphetamine, and fentanyl.146 schedule iii controlled substances have a potential for abuse less than schedule i or ii substances and abuse may lead to moderate or low physical dependence or high psychological dependence.147 this schedule includes substances such as ketamine, products containing not more than ninety milligrams of codeine per dosage unite, and anabolic steroids.148 schedule iv controlled substances have a low potential for abuse as compared to schedule iii.149 schedule iv substances include clonazepam, diazepam (valium), and alprazolam (xanax).150 finally, schedule v controlled substances have a low potential for abuse in comparison to schedule iv substances and consist primarily of preparations containing limited quantities of certain narcotics.151 this includes substances such as cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams and ezogabine.152 opioids are a derived form of opium which is found in the asian poppy plant or a synthetic substance.153 opioids typically have a significant effect on an 139. controlled substance schedules, drug enforcement administration, https://www. deadiversion.usdoj.gov/schedules/ [https://perma.cc/6qs5-u2de]. 140. 21 c.f.r. §§ 1308.11 1308.15 (2018). 141. controlled substance schedules, supra note 137. 142. id. 143. id. 144. id. 145. id. 146. id. 147. id. 148. id. 149. id. 150. id. 151. id. 152. id. 153. id. 2019] hoosiers leading the way 317 individual’s perception of pain and therefore are widely used in the medical setting to treat pain.154 many controlled substances are classified as an opioid and all opioids are classified as controlled substances.155 opioids can be found in all five schedules of the csa’s classification.156 for example, the schedule i drug heroin in probably the most well-known opioid.157 schedule ii methadone, fentanyl, and oxycodone, schedule iii buprenorphine products, schedule iv tramadol, and schedule v preparations made with codeine are also popular opioids.158 in order to legally obtain a controlled substance deemed a schedule ii through v,159 a patient must have special permission, which typically comes in the form of a written prescription.160 however, despite the requirement that these substances are obtained legally through a medical prescription, the u.s. is facing a significant opioid misuse and abuse problem.161 opioid use, whether prescribed by a provider or not, can have a significant effect on the brain and body if misused.162 continued abuse of opioids can lead to physical dependence and withdrawal symptoms if the individual attempts to stop usage after mismanagement.163 in indiana, opioid prescription rates rose from 103 per 100 population in 2008 to a peak of 112 per 100 population in 2012.164 since 2012, rates have been dropping with a rate of 84 prescriptions per 100 population in 2016.165 however, opioid-related death rates have risen from 4.5 per 100,000 population in 2008, to 11.7 per 100,000 in 2016.166 drug deaths related to heroin and synthetic opioids have increased sharply, beginning in 2011 and 2015, respectively.167 154. id. 155. which opiates are listed as controlled substances?, am. addiction centers, https://americanaddictioncenters.org/opiates/controlled-substances/ [https://perma.cc/xm8bhmza]. 156. id. 157. id. 158. id. 159. substances classified as schedule i cannot legally be obtained except with the permission of the u.s. government because they have been found to provide no medical purposes. which opiates are listed as controlled substances?, supra note 153. 160. id. 161. it all starts with knowledge and understanding the facts, nextlevel recovery ind., http://www.in.gov/recovery/know-the-o/ [https://perma.cc/326g-u9pu]. 162. id. 163. id. 164. data: indiana by the numbers, nextlevel recovery ind., http://www.in.gov/recovery/ 1054.htm [https://perma.cc/np5l-m4py]. 165. id. 166. id. 167. id. 318 indiana health law review [vol. 16:299 c. governing authorities in true health care fashion, telemedicine is subject to a wide array of laws, regulations, rules, and policies by the federal and state governments as well as the private sector. just like traditional health care services, telemedicine faces regulations regarding cross-state licensure, informed consent, antitrust, fraud and abuse, and much more.168 however, there is a disconnect between state laws and the policies of individual organizations. additionally, states differ on what restrictions are placed on the prescribing practices of telemedicine providers, particularly in terms of controlled substances prescription. an analysis of recent changes to the indiana code will demonstrate how indiana is supplying providers with the toolkit (i.e. a selection of medications they can prescribe) to effectively treat patients via telemedicine while still avoiding the risks associated with providing prescriptions for opioids without in-person consultation. 1. federal regulations just as with in-person medical treatment, telemedicine, particularly the prescribing practices thereof, raises a number of legal concerns. the ryan haight online pharmacy consumer protection act (“rhopcpa”) was created to address online pharmacies that sold controlled substances online.169 the act imposes federal penalties for providers who prescribe controlled substances via the internet using only a form as the method of diagnosis.170 while providers who wish to prescribe controlled substances via telemedicine services need to be in compliance with the regulations set in place by the act, it does not prohibit the prescription of controlled substances via telemedicine as a whole.171 as mentioned previously, the csa places substances that are regulated in some manner by federal law into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability.172 21 u.s.c. § 829 specifically discusses dispensing controlled substances via the internet.173 controlled substances may only be delivered, distributed, or dispensed via the internet with a valid prescription.174 a practitioner who provides such a prescription must have either conducted at least one in-person medical evaluation 168. telehealth legal and regulatory module, telehealth resource center, https://www.telehealthresourcecenter.org/legal-regulatory [https://perma.cc/h2l6-c7b5]. 169. ryan haight online pharmacy consumer protection act of 2008, 110 pub. l. no. 425, 122 stat. 4820. 170. nathaniel m. lacktman, telemedicine prescribing and controlled substances laws, health care law today (apr. 3, 2017), https://www.healthcarelawtoday.com/2017/04/03/ telemedicine-prescribing-and-controlled-substances-laws/ [https://perma.cc/b8uc-jvey]. 171. id. 172. the controlled substances act, drug enforcement agency, https://www.dea.gov/ controlled-substances-act [https://perma.cc/2h8t-zdsl]. 173. controlled substances act, 12 c.f.r. § 829 (2018). 174. id. 2019] hoosiers leading the way 319 of the patient or conducted an evaluation of the patient through the practice of telemedicine within the previous twenty-four months.175 a provider who is practicing telemedicine is still required to follow the regulation that controlled substance prescriptions must be for a legitimate medical purpose and the prescriber must be acting within the usual course of professional practice.176 on may 4, 2017, the u.s. house of representatives passed the american health care act of 2017.177 although it did not become law, it is still applicable to point out in an analysis of federal law that the bill did not specifically incorporate the words “telehealth” or “telemedicine,”178 suggesting that the federal government wishes to leave specific telemedicine regulations up to the states. 2. state regulations although there are similarities in some of the statutory language used, no state statutes are exactly alike in how they regulate telemedicine.179 prior to 2016, indiana’s telehealth services pilot program was the governing state rule on such activity.180 a valid prescription was defined as one provided by a licensed physician for a legitimate medical purpose.181 additionally, the prescribing physician must be acting in the usual course of professional practice and have first obtained a medical history and conducted an evaluation of the patient adequate to establish a diagnosis.182 the pilot program prescription requirement provided that “prescriptions [could] not be issued for a controlled substance or an abortifacient.”183 d. changes in indiana telemedicine prescribing laws in 2016 and 2017 as of 2018, indiana has undergone two amendments to the indiana code sections governing the practice of indiana telemedicine.184 175. id. 176. 74 c.f.r. § 1300 (2009). 177. h.r. 1628 american health care act of 2017, congress.gov, https://www.congress. gov/bill/115th-congress/house-bill/1628/text [https://perma.cc/xtz9-rgyw]. 178. id. 179. state telehealth laws and reimbursement policies report, centers for connected health pol’y, http://www.cchpca.org/state-telehealth-laws-and-reimbursement-policies-report [https://perma.cc/knp3-98m3]. 180. ind. code 5-8 (2015). 181. ind. code 5-8-2(g) (2015). 182. ind. code 5-8-2(g) (2015). 183. ind. code 5-8-3(4) (2015). 184. ind. code 25-1-9.5-8 (2017). 320 indiana health law review [vol. 16:299 1. house enrolled act 1263: 2016 in 2016, indiana governor mike pence signed into law indiana house enrolled act no. 1263 (“hea 1263”).185 hea 1263 replaced the previously mentioned indiana telehealth pilot program. part of this amendment allows indiana providers, assuming they have established a provider-patient relationship, to issue a prescription to a patient who is receiving telemedicine services.186 in order to establish a provider-patient relationship via telemedicine, the provider must, at a minimum, obtain the patient’s name, contact information, and location.187 additionally, the provider must disclose his or her name and his or her role as a provider (i.e., physician, physician assistant, advanced practice nurse, or optometrist).188 the provider is also required to (1) obtain informed consent from the patient; (2) gather the patient’s medical history and other information deemed necessary to make a diagnosis; (3) discuss with the patient the diagnosis and risks and benefits of different treatment options; (4) create and maintain a medical record for the patient; (5) issue proper follow-up care instruction; and (6) provide a telemedicine visit summary to the patient.189 most important to the substance of this note, the act allows providers to issue certain prescriptions without ever having to see the patient in person. this includes all prescriptions so long as they are not for a controlled substance, an abortion inducing drug, or an ophthalmic device.190 while hea 1263 made great strides in telemedicine practices in indiana, the legislature further amended the indiana code a year later to allow providers even further autonomy in their medical treatment decisions. 2. house enrolled act 1337: 2017 effective july 1, 2017, was yet another amendment to the indiana code concerning telehealth via house enrolled act 1337 (“hea 1337”).191 in particular, this amendment further altered the prescription regulations on telemedicine services. the amendment removed the regulation that barred the prescription of controlled substances.192 instead, the law now allows providers to prescribe non-opioid controlled substances via telemedicine without an initial inperson examination by the prescriber.193 however, the patient is still required to be examined in-person by an indiana provider to establish a treatment plan to 185. actions for house bill 1263, in.gov, http://iga.in.gov/legislative/2016/bills/house/ 1263#document-46a1685d (last reviewed mar. 15, 2019). 186. h.b. 1263, 119th gen. assemb., reg. sess. (ind. 2016). 187. id. 188. id. 189. id. 190. ind. code 25-1-9.5-8 (2017). h.b. 1263, 119th gen. assemb., reg. sess. (ind. 2016). 191. h.b. 1337, 120th gen. assemb., reg. sess. (ind. 2017). 192. id. 193. id. however, the amendment does allow for an opioid prescription if the opioid is a partial agonist being used to treat or manage opioid dependence. 2019] hoosiers leading the way 321 assist the prescriber with the patient’s diagnosis. in short, the indiana code has already been amended twice to reduce the restrictions on physicians offering telemedicine, particularly regarding their online prescribing abilities. this provides indiana physicians with the ability to access a wide array of treatment options for their telemedicine patients. e. indiana in comparison in comparison to other state’s statutes, indiana’s amendments land it in the middle ground of allowable prescription practices via telemedicine, particularly, prescriptions of controlled substances.194 most states at least have some form of policy or statement on internet prescribing.195 like indiana, most states do not allow remote prescribing of abortion inducing drugs.196 also similar to indiana, alaska allows the prescribing of controlled substances via telemedicine when certain requirements are met, such as the provider maintaining a clear record that includes the patient’s history, diagnosis, monitoring, and drugs prescribed.197 ohio telemedicine legislation also allows for the prescription of controlled substances via telemedicine, but in a very restrictive manner. for a prescription to be provided legally, both the provider and the patient must meet a series of requirements.198 these requirements include that (1) the patient is an “active patient” of a colleague of the physician, and the prescription is being provided through an on-call or cross-coverage arrangement. an “active patient” is defined as a patient who has been seen at least once in the past 24 months by the physician, either in person or through a telemedicine visit; (2) the patient is at a drug enforcement agency-registered hospital or clinic; (3) the patient is being treated by, and in the physical presence of, an ohio-licensed physician or health care practitioner registered with the dea; (4) the telemedicine consult is conducted by a practitioner who has obtained a dea special registration for telemedicine; (5) a hospice program physician prescribes the controlled substance to a 194. latoya thomas & gary capistrant, state telemedicine gaps analysis, am. telemedicine ass’n (2017), http://utn.org/resources/downloads/50-state-telemedicine-gapsanalysis-physician-practice-standards-licensure.pdf [https://perma.cc/7wbr-uht9]. 195. id. 196. id. 197. federation of state medical boards, internet prescribing language: stateb y-st at e ov er v iew 1 (2012), https://web.archive.org/web/20150528220742/ h ttp : / /ww w . f smb.org/media/defau lt /pdf/advocacy/in ternetprescribinglaw.pdf [https://perma.cc/8veh-fcw2]. 198. ohio admin. code 4731-11-09 (2017). 322 indiana health law review [vol. 16:299 hospice program patient in accordance with the board of pharmacy rules; or; (6) the physician is the medical director of, or attending physician at, an “institutional facility,” the patient has been admitted as an inpatient to or is a resident of an institutional facility, and the prescription is transmitted to the pharmacy by a means that is compliant with ohio board of pharmacy rules.199 f. non-legally binding policies 1. telemedicine providing organizations the individual organization providing telemedicine is the primary source of governance for a provider’s online prescription practices. for example, providers for teladoc, a company that provides the platform to speak with a licensed provider via web, phone, or mobile app,200 offer prescriptions via a telemedicine visit for a wide range of medical conditions.201 however, teladoc notes that its providers are limited by the regulations of the state in which they are practicing and the state in which the patient resides.202 teladoc chooses not to allow the prescription of controlled substances, non-therapeutic medications, or other drugs that may be harmful to patients due to the proclivity for their abuse.203 similarly, iu health and chn do not allow their providers to prescribe controlled substances via their telemedicine services.204 2. american medical association much like the american bar association’s model rules of professional conduct205 lays out ethical considerations for attorneys in their practice of law, the ama code of medical ethics provides standards of conduct for physicians in their practice of medicine.”206 the ama’s council on ethics and judicial affairs developed new ethical guidance on telehealth and telemedicine. in june 199. id. 200. teladoc, https://www.teladoc.com [https://perma.cc/uk5b-mlct]. 201. teladoc’s prescription policy, teladoc, https://www.teladoc.com/providers/ prescription-policy/ [https://perma.cc/tsz7-9kyu]. 202. id. 203. id. 204. iu health video visits frequently asked questions, supra note 71; see drug schedules 1-5, ind. state dep’t health, https://www.in.gov/isdh/27380.htm [https://perma.cc/sg56-442v] (listing controlled substances in indiana). 205. model rules of professional conduct, a.b.a., https://www.americanbar.org/groups/ professional_responsibility/publications/model_rules_of_professional_conduct/model_rules_of _professional_conduct_table_of_contents.html [https://perma.cc/29rx-hm6v]. 206. ama code of medical ethics, ama, https://www.ama-assn.org/delivering-care/amacode-medical-ethics [https://perma.cc/xf67-m494]. 2019] hoosiers leading the way 323 2016, the guidelines were adopted at the ama’s annual meeting.207 the ama stated that no matter the model of care a provider is using, the patient should be able to trust that his or her provider will place the patient’s welfare above other interests.208 additionally, it is critical that providers deliver competent care, provide patients with the information necessary to make informed decisions about their care, and respect patients’ privacy and confidentiality requirements.209 per policy h-480.948, coverage of and payment for telemedicine, the ama makes its own statement regarding what is required by a provider to create a patient-physician relationship in order to provide telemedicine services: the ama believes that a valid patient-physician relationship must be established before the provision of telemedicine services, through: (i) a face-to-face examination, if a face-to-face encounter would otherwise be required in the provision of the same service not delivered via telemedicine; or (ii) a consultation with another physician who has an ongoing patient-physician relationship with the patient. the physician who has established a valid physician-patient relationship must agree to supervise the patient’s care; or (iii) meeting standards of establishing a patient-physician relationship included as part of evidence-based clinical practice guidelines on telemedicine developed by major medical specialty societies, such as those of radiology and pathology. exceptions include on-call, cross coverage situations; emergency medical treatment; and other exceptions that become recognized as meeting or improving the standard of care. if a medical home does not exist, telemedicine providers should facilitate the identification of medical homes and treating physicians where in-person services can be delivered in coordination with the telemedicine services.210 there is a major disconnect between what indiana state laws allow providers to do in terms of prescribing medications via telemedicine and what indiana telemedicine organizations allow of their providers. while state law now allows providers to prescribe non-opioid controlled substances via telemedicine, so long as they meet the necessary requirements, telemedicine organizations such as teladoc, iu health, and chn do not allow their providers to prescribe controlled substances. this places an unnecessary restriction on these particular providers and limits their “toolkit” in treating their patients. 207. ama adopts new guidance for ethical practice in telemedicine, ama, (june 13, 2016), h t tps:/ /www.ama-assn.org/ama-adopts-new-guidance-ethical-practice-telemedicine [https://perma.cc/c2c5-dqsd]. 208. id. 209. id. 210. am. med. ass’n, 50-state survey: establishment of a patient-physician relationship via telemedicine (2017), https://www.ama-assn.org/sites/default/files/mediabrowser/specialty%20group/arc/ama-chart-telemedicine-patient-physician-relationship.pdf [https://perma.cc/cp9t-wh8m]. 324 indiana health law review [vol. 16:299 iv. conclusion hospitals offering telemedicine services will increase access to care for their served community and will decrease their expenditure on health care services (primarily for urgent/primary care). it is important that states focus their telemedicine prescribing laws so as to allow providers with enough leeway to efficiently treat their patients while also avoiding harm to the patient or promoting opioid overuse. indiana’s updated telemedicine prescribing laws are a respectable middle ground and should be mirrored in other states’ laws. in light of the recent opioid epidemic, physicians need to be vigilant about their prescription of opioids. however, many non-opioid controlled substances are an effective tool in treating illness and these substances should be available to telemedicine providers. the updates to the indiana code may result in the board of medicine needing to rewrite some of its current telemedicine regulations to avoid conflict with the controlling provisions of the statute.”211 the hoosier state is doing well to serve as a role model for other states in the restructuring of their laws to provide greater access for patients at a lower cost and to give providers the toolkit they need to remotely provide services. 211. nathaniel m. lacktman, key takeaways from indiana's new telemedicine law, health care law today (mar. 28, 2016) https://www.healthcarelawtoday.com/2016/03/28/keytakeaways-from-indianas-new-telemedicine-law/ [https://perma.cc/5tlp-xpu3]. the latest “federal movement” in the food and drug law arena: the federal right-to-try or rather right-to-know and thus request investigational therapies for individuals with a life-threatening disease or condition roseann b. termini* i. introduction the national state movement regarding right-to-try state legislation spurred the enactment of the federal right-to-try legislation passed in 2018.1 yet, even prior to the enactment of the federal right-to-try law, the united states federal food and drug administration (fda) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial.2 does the federal right-totry act provide improved access for the desperately ill? will insurance companies provide reimbursement for a patient to undergo such investigational therapies? is the manufacturer protected in terms of lawsuits? that is, does the patient relinquish the right to bring a legal action? will physicians comprehend the pathway and advocate for their patients? does this new law guarantee “any novel federal right”? this article provides a federal primer on the investigational drug, biologic and device process,3 details a similar national right-to-know movement in the * roseann b. termini, b. s. magna cum laude, m.ed. fellow, j.d., a food and drug law attorney, teaches several food and drug law courses at delaware law school, widener university school of law and is the author of food and drug law: federal regulation of drugs, biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products www.fortipublications.com (2017). ms. termini dedicates this article to the memory of her parents who instilled values that fostered the determination to write this article. she specially acknowledges ms. janet lindenmuth, m.s., research law librarian at delaware law school who provided valuable research for this article. finally, ms. termini thanks her children and non-lawyer friends for reading the drafts of this article to comport with plain language as much as possible considering this complex area of law. “we now arrive at the end of our journey through the thicket of the food, drug and cosmetic act. we are mindful of learned hand’s consoling words on his foray through the internal revenue act: “cross-reference to cross-reference, exception upon exception—couched in abstract terms . . . but successfully concealed, . . . which it is my duty to extract, but . . . only after the most inordinate expenditure of time.” i. dilliard, the spirit of liberty 236 (3rd ed. 1960), united states v. french bronze tablets fbnh enterprises, inc. 888 f.2d 945, 949 (2nd cir. 1989). author contact rbtermini@widener.edu 1. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). although titled right to try act of 2017, this law was passed on may 30, 2018. 2. 21 u.s.c. § 360bbb (2012) (expanding access to unapproved therapies and diagnostics). 3. roseann b. termini, food and drug law: federal regulation of drugs, biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products 131-34 (9th ed. 2017). http://doi.org/10.18060/3911.0056 102 indiana health law review [vol. 16:101 food and drug law arena that led to federal legislation perhaps comparable to how the federal right-to-try act4 was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the federal right-to-try act.5 there are more queries than unambiguous answers regarding the recently enacted federal right-to-try act.6 the federal law in essence could prove troublesome and confusing with both the state right-to-try measures due to, for instance, issues of national uniformity and preemption.7 the recently enacted federal right-to-try act8 adequate safeguards and perhaps a false unrealistic sense of hope?9 a look back provides insight to the current matter. in 2006, the federal courts grappled with this issue.10 appellate court was faced with deciding if there was a constitutionally protected right to potentially lifesaving investigational medical therapies in the federal case of abigail alliance for better access to developmental drugs and washington legal foundation v. von eschenbach (abigail alliance).11 in abigail alliance, the court of appeals held that terminally ill patients do not have a constitutional right to obtain investigational drugs prior to the federal food and drug administration (fda) approval.12 the united states supreme court declined to review the federal appeals court decision.13 however, according to the goldwater institute, in the last few years, approximately 41 states have enacted legislation that addresses investigational drug access by the terminally ill.14 these states include: alabama, alaska, arizona, arkansas, california, 4. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 5. id. 6. id. 7. u.s. const. art. vi, cl. 2. the doctrine of preemption emanates from the supremacy clause (article vi, clause 2) of the united states constitution. article vi, clause 2 prohibits states from enacting laws that conflict with federal law unless the federal law contains explicit preemption language. 8. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 9. see, e.g., marilyn j. heine & bruce e. johnson, caution to patients on ‘right to try,’ phila. inquirer, oct. 20, 2017, at a15. see also amanda bennett, the cost of hope: a memoir (2012). 10. abigail all. for better access to dev. drugs v. von eschenbach, 469 f.3d 129 (d.c. cir. 2006), aff’d, 495 f.3d 695 (d.c. cir. 2007). 11. id. 12. id. 13. abigail all. for better access to dev. drugs v. von eschenbach, 469 f.3d 129 (d.c. cir. 2006), aff’d, 495 f.3d 695 (d.c. cir. 2007), cert. denied, 552 u.s. 1159 (2008). 14. alaska becomes 41st state to enact right to try legislation, goldwater inst. (july 13, 2018), http://righttotry.org/alaska-becomes-41st-state-to-enact-right-to-try-legislation/ [https://perma.cc/6sun-mc73]. the goldwater institute is a public policy conservative based organization located in phoenix, arizona. 2018] the latest “federal movement” in the food and drug law arena 103 colorado, connecticut, florida, georgia, idaho, illinois, indiana, iowa, kentucky, louisiana, maine, maryland, michigan, minnesota, mississippi, missouri, montana, nebraska, nevada, new hampshire, north carolina, north dakota, ohio, oklahoma, oregon, pennsylvania, south carolina, south dakota, tennessee, texas, utah, virginia, washington, west virginia, wisconsin, and wyoming.15 colorado was the first state to enact right-to-try legislation back in 2014.16 the colorado law right-to-try act includes investigational medical devices.17 the federal right-to-try act18 does not address and is silent regarding investigational devices. however, prior legislative bills indicate devices were considered.19 this could prove problematic in terms of preemption issues.20 yet, do these laws provide those who are desperately ill patients with “unrealistic false hope” by promising access to therapies that may not work or may cause harm, and that they may not even receive?21 are the state right-to-try laws usurping fda authority?22 does the recently enacted federal right-to-try act provide additional benefits to the patient than what is already provided by the fda expanded use? alternatively, does the federal right-to-try act deny access as access is contingent on the physician, manufacturer and insurance companies to acquiesce? who pays for access? 15. id. 16. access to treatments for terminally ill patients, colo. rev. stat. ann. § 25-45 (west 2014) (this article is known and may be cited as the “right to try act”). 17. § 25-45-102 (west 2014). 18. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 19. see, e.g., h.r. 878, 115th cong. (2017-2018) (obligating the federal government to permit unrestricted manufacturing, “distribution, prescribing, or dispensing of an experimental drug, biological product, or [medical] device that is intended to treat a patient who has been diagnosed with a terminal illness.”); see also h.r. 2368, 115th cong. (2017-2018) (“this bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are authorized by state law and intended to treat terminally ill patients.”) cong. res. serv., h.r. 2368: right to try act, govtrack, https://www.govtrack.us/congress/bills/115/hr2368/summary [https://perma.cc/ gkr4-23aw]. 20. u.s. const. art. vi, cl.2. the doctrine of preemption emanates from the supremacy clause (article vi, clause 2) of the united states constitution. article vi, clause 2 prohibits states from enacting laws that conflict with federal law unless the federal law contains explicit preemption language. 21. see alison bateman-house & arthur caplan, drug-right bills give patients false hope, phila. inquirer, nov. 16, 2014, at b1 (concluding that state “right to try” laws could actually harm a terminally ill patient. 22. u.s. const. art. vi, cl.2. the doctrine of preemption emanates from the supremacy clause (article vi, clause 2) of the united states constitution. article vi, clause 2 prohibits states from enacting laws that conflict with federal law unless the federal law contains explicit preemption language. 104 indiana health law review [vol. 16:101 is informed consent adequately explained or in reality a protection mechanism for physicians?23 these are complex questions without straightforward answers and there are various participants involved in this process besides the patient and the health care provider. drug and medical device manufacturers, distributors, insurers and the health care providers have a significant role. to establish the tone of how the national state movement spurred federal legislation in the food and drug law realm, the bioengineered act24 provides insight. next, a federal primer provides a synopsis of the federal investigation drug and medical device process. following this, by way of illustration, is an overview of the federal right-to-try legislation and a state comparison using the right-to-try legislation enacted in maryland as an illustration.25 finally, the focus of this article is on the individual patient’s right to try or request an investigational product. ii. a federal rush to enactment—perhaps a lesson learned from the right-to-know and the national bioengineered food disclosure standard for years, consumers advocated for a right-to-know on food labelling of bioengineered food.26 finally, the national bioengineered food disclosure standard (bioengineered food disclosure), was passed july 29, 2016 which amended the agricultural marketing act.27 as background, several states passed genetically modified organisms (gmo) laws.28 for example, in 2013, connecticut passed a law with a “trigger clause” which means the gmo law would only go into effect if nearby states also passed gmo labeling laws.29 similarly, in 2014, maine passed a gmo labeling law that required foods containing (gmo) to be labeled as such however it contained a “trigger clause”.30 in 2015, the maine legislature proposed a new law that would remove the trigger 23. 21 u.s.c. § 360bbb-0a (2018); trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018); md. code ann., health-gen. § 21-2b-01 (west 2018) (see appendix v). 24. national bioengineered food disclosure standard, pub. l. no. 114-216, 130 stat. 834 (2016). 25. md. code ann., health-gen. § 21-2b-01 (west 2018). 26. national bioengineered food disclosure standard, pub. l. no. 114-216, 130 stat. 834 (2016); see lawrence o. gostin, genetically modified food labeling: a “right to know”?, jama network (dec. 13, 2016), https://jamanetwork.com/journals/jama/fullarticle/2592487 [https://perma.cc/g427-n7um]. 27. id. 28. see, e.g., conn. gen. stat. § 21a-92c (2013); me. rev. stat. ann. tit. 22, § 2593 (2014); vt. stat. ann. tit. 9, § 3043 (west 2014). 29. conn. gen. stat. § 21a-92c (2013). 30. me. rev. stat. ann. tit. 22, § 2592 (2014). 2018] the latest “federal movement” in the food and drug law arena 105 clause requirement that relies on other states.31 finally, vermont enacted a gmo law without a trigger clause.32 possibly the federal bioengineered food disclosure law was enacted in response to state (gmo) legislation such as the vermont gmo law.33 the united states department of agriculture is tasked with the responsibility of promulgating regulations to implement the bioengineered food disclosure.34 yet, prior to the bioengineered food disclosure law, companies initiated proactive disclosure and either eliminate gmo ingredients or disclose gmo ingredients. for example, in july 2016, the dannon yogurt company removed gmo ingredients in some products and disclosed gmo ingredients in the labeling of other products.35 yet, with any law that is shepherded through and 31. me. rev. stat. ann. tit. 22, §§ 2591-2595 (2015). “this bill requires disclosure of genetic engineering at the point of retail sale of food and seed stock and provides that food or seed stock for which the disclosure is not made is considered to be misbranded and subject to the sanctions for misbranding. the bill provides that food or seed stock may not be labeled as natural if it has been genetically engineered. the bill exempts products produced without knowledge that the products, or items used in their production, were genetically engineered; animal products derived from an animal that was not genetically engineered but was fed genetically engineered food; and products with only a minimum content produced by genetic engineering. the bill also provides that the disclosure requirements do not apply to restaurants, alcoholic beverages or medical food. the disclosure provisions are administered by the department of agriculture, conservation and forestry.” an act to protect maine food consumers’ right to know about genetically engineered food and seed stock: summary, office of legislative information, https://www.mainelegislatu re.org/ legis/bills/bills_126th /billtexts/hp049001 .asp [https://perma.cc/lf5h-mcl3]. 32. vt. stat. ann. tit. 9, § 3043 (west 2014). 33. vt. stat. ann. tit. 9 § 3043 (west 2014); national bioengineered food disclosure standard, pub. l. no. 114-216, 130 stat. 834 (2016). 34. national bioengineered food disclosure standard, pub. l. no. 114-216, 130 stat. 834 (2016). “public law 114-216 amended the agricultural marketing act of 1946 (7 u.s.c. 1621 et seq.), as amended (amended act), by adding subtitles e and f. subtitle e of the amended act directs the secretary to establish the national bioengineered food disclosure standard (nbfds) for disclosing any be food and any food that may be bioengineered. subtitle e also directs the secretary to establish requirements and procedures necessary to carry out the new standard. additionally, the amended act directs the secretary to conduct a study to identify potential technological challenges related to electronic or digital disclosure methods. see 7 u.s.c. 1639b(c)(1). subtitle f addresses federal preemption of state and local genetic engineering labeling requirements. subtitle f also specifies that certification of food under the u.s. department of agriculture’s (usda) national organic program (nop) (7 cfr part 205) shall be considered sufficient to make claims about the absence of bioengineering in the food.” national bioengineered food disclosure standard, 83 fed. reg. 19860 (proposed may 4, 2018) (to be codified at 7 c.f.r. pt. 66). 35. see dannon announces breakthrough sweeping commitment for sustainable agriculture, more natural ingredients and greater transparency, dannon (apr. 27, 2016), 106 indiana health law review [vol. 16:101 reactive to state legislation, as the federal bioengineered food disclosure law, questions remain such as exemptions and implementation time.36 a comparative analogy is applicable to the federal right-to-try act in terms of reactive legislation to state right to try legislation. for example, why are medical foods not included nor addressed in the federal right-to-try act?37 these are unanswered queries. does the federal law provide anything new to a terminally ill patient? does the patient understand the right to bring a lawsuit is thwarted?38 was there political pressure to enact federal right-to-try legislation? did the state right-to-try acts spur the federal legislation? unequivocally, the state right-to-try legislative movement did spur federal action. perhaps uniformity is preferred rather than various state laws. however, the state right-totry certainly fostered congress to act in 2018.39 prior to delving into the federal right-to-try act,40 the following primer details the investigational drug schemata. iii. federal primer—investigational human drugs and biological drug products and expanded access the food and drug administration is the oldest comprehensive consumer http://www.dannon.com/the-dannon-pledge-on-sustainable-agriculture-naturality-and-transparency/ [https://perma.cc/u5b9-ng77]. 36. see jennifer a. staman, cong. research serv., r43705, legal issues with federal labeling of gen et ic ally engineered food: in brief (2016). http://nationalaglawcenter.org/wp-content/uploads/assets/crs/r43705.pdf [https://perma.cc/pw4hy982]; see also greg jaffe, the abcs of gmo disclosure in the united states, ctr for science pub. int. (sept. 25, 2017), https://cspinet.org/news/abcs-gmo-disclosure-united-states-20170925 [https://perma.cc/2lwa-5p9k]. 37. medical foods is defined under the federal, food, drug and cosmetic act in section 5(b) of the orphan drug act 21 (u.s.c. § 360ee(b)(3)) as follows: “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” 21 u.s.c. §360ee(b)(3) (2017). 38. 21 u.s.c. § 360bbb-0a(b) (2017) (1) alleged acts or omissions. with respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561b of the federal food, drug, and cosmetic act and in compliance with such section, no liability in a cause of action shall lie against (a) a sponsor or manufacturer; or (b) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable state law. 39. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 40. id. 2018] the latest “federal movement” in the food and drug law arena 107 protection agency in the united states federal government.41 striking the appropriate balance between free enterprise principles and obligatory government intervention is one of the most debated components of fda regulation.42 at the forefront, it is critical to understand the mission of the fda as follows: “the food and drug administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”43 yet, public protection is paramount.44 keeping the mission of the fda in the forefront, the fda aims to foster and protect public health through prompt and efficient review of clinical research and taking appropriate action on the marketing of regulated products in a timely manner.45 yet, this could be deemed insufficient for those who are desperately ill and seeking treatment for experimental products in a timely manner.46 access to unapproved drugs includes participation in a clinical trial detailed below.47 eligibility parameters are specified in a protocol.48 however, even if the eligibility criteria in a study protocol is not appropriate for a specific patient treatment, it may be possible to obtain the investigational treatment as a special exception termed expanded access generally referred to as compassionate use.49 expanded access, or as indicated, popularly referred to as compassionate use, is the use outside of a clinical trial50 of an investigational medical product that has 41. the fda history office, u.s. food & drug admin., https://www.fda.gov/aboutfda/ history/fdahistoryoffice/default.htm [https://perma.cc/3jva-b8fe] (last updated feb. 1, 2018); ben panko, where did the fda come from, and what does it do?, smithsonian.com (feb. 8, 2017), https://www.smithsonianmag.com/science-nature/origins-fda-what-does-it-do-180962054/ [https://perma.cc/m2pe-687d]. 42. roseann b. termini, food and drug law: federal regulation of drugs, biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products 5 (9th ed. 2017). 43. what we do, u.s. food & drug admin., https://www.fda.gov/aboutfda/whatwedo [https://perma.cc/42xl-ep2b] (last updated mar. 28, 2018). 44. id. 45. fda center for drug evaluation and research (cder) strategic plan 2013-2017, u.s. food & drug admin., 3, https://www.fda.gov/downloads/aboutfda/centersoffices/officeof medicalproductsandtobacco/cder/ucm376545.pdf [https://perma.cc/n3w9-uqcx]. 46. clinical trials have eligibility criteria and at times patients are ineligible. see, e.g., expanded access (sometimes called “compassionate use”), u.s. food & drug admin., https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/defau lt.htm [https://perma.cc/kqk7-8q7x] (last updated june 19, 2018). 47. learn about clinical studies, u.s. nat’l libr. of med., https://clinicaltrials.gov/ct2/ about-studies/learn [https://perma.cc/l6f2-p9kq] (last updated jan. 2017). 48. id. 49. 21 c.f.r. § 312.300 (2018). 50. the u.s. national library of medicine’s website, clinicaltrials.gov, contains 108 indiana health law review [vol. 16:101 not been yet approved by the fda.51 the fda approval rate for compassionate use therapy is ninety-nine percent.52 treating a patient as a special exception entails modifying the informed consent form, sending the request to the fda, and acquiring permission from an institutional review board (irb).53 however, when treatment involves the emergency use of an investigational drug and approval from an irb cannot be obtained before treatment, treatment may begin without prior irb approval provided the irb is notified of the emergency expanded access use within five working days of treatment.54 it also requires agreement of the manufacturer to provide the requested information about publicly and privately funded trials concerning safety and efficacy studies for phase ii drug approval process, phase iii drug approval process and post market phase iv initiatives to require increased disclosure of clinical trial information remain in the forefront. as of july 21, 2018, there were 278,399 research studies in all 50 states and in 204 countries. u.s. nat’l libr. of med., https://clinicaltrials.gov [https://perma.cc/8269-62rt]. 51. expanded access categories for drugs (including biologics), u.s. food & drug admin., https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/ ucm431774.htm [https://perma.cc/57nw-tqv6] (last updated jan. 4, 2018). 52. expanded access inds and protocols 2009-2017, u.s. food & drug admin., https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm4 43572.htm [https://perma.cc/74k3-g75z] (last updated feb. 21, 2018). see appendix i at the conclusion of this article. see also expanded access inds and protocols 2009-2015, u.s. food & drug admin., https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredeveloped andapproved/drugandbiologicapprovalreports/ indactivityreports/ucm373560 .h tm [https://perma.cc/q9rt-2a2l]. 53. id. see also expanded access to investigational drugs for treatment use —questions and answers, guidance for industry, u.s. dep’t of health and human services, food & drug admin., ctr. for drug evaluation and res., ctr. for biologics evaluation and res. (oct. 2017), https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf. “a physician submitting an individual patient expanded access ind using form fda 3926 may select the appropriate box on that form to request a waiver under § 56.105 of the requirements in § 56.108(c), which relate to full irb review. fda concludes that such a waiver is appropriate for individual patient expanded access inds when the physician obtains concurrence by the irb chairperson or another designated irb member before treatment use begins. a physician submitting an individual patient expanded access ind using form fda 1571 may include a separate waiver request with the application.” id. at 6. further, the guidance defines and institutional review board (irb) as follows. “an institutional review board (irb) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects. the primary purpose of irb review is to assure that the rights and welfare of human subjects are protected, including by determining that informed consent is obtained in accordance with and to the extent required by federal requirements. institutions may have their own irb to oversee human subjects research conducted within the institution or by the staff of the institution. if the patient’s physician does not have access to a local irb, an independent irb may be used. the department of health and human services’ office for human research protections maintains a database of registered irbs.” id. at 5, n. 11. 54. 21 c.f.r. § 56.104 (2018). 2018] the latest “federal movement” in the food and drug law arena 109 investigational medical product. the health care practitioner is involved as well as the insurance company. as noted, several entities must acquiesce to the expanded use. iv. federal primer mechanisms investigational new drugs (ind) and devices investigational new drugs (inds) a review of the parameters for investigational new drugs is daunting. yet, in a sense it should be in order to protect the human being. what should not be formidable is the process to obtain a potential lifesaving treatment. that is, the issue and perhaps the state right-to-try and now the federal right-to-try act is the panacea in terms of a patient’s right-to-know that there is possibly an experimental drug. the panacea is a right-to-request a potentially life extending treatment with the caveat that the treatment is not necessarily a cure and the patient may not receive the treatment for a variety of reasons such as cost and manufacturer willingness to supply the product. in brief, the types of investigator new drugs (ind) include the following: investigator ind, emergency use ind, and treatment ind.55 once a sponsor submits an ind application, there is a thirty-day waiting period before commencing any clinical trials, for safety reasons.56 thirty days is too lengthy for those who are desperately ill. that is why fda has a compassionate expanded use program available.57 investigator ind submissions—by a physician and the investigation is under direct control of the physician. for example, a physician could propose a research ind to suggest studying an unapproved drug. a physician could also propose a research ind for a new indication or for a new patient population.58 emergency use inds—fda permits use of an experimental drug in an emergency situation. this means that there is insufficient time for submission of an ind.59 an emergency ind can be used for those patients who do not satisfy the conditions of an existing study protocol or possibly if there is no approved study protocol.60 55. 21 c. f. r. § 312.34 (2018) (treatment use of an investigational new drug). 56. 21 c.f.r. § 312.305 (2018). 57. id. (requirements for all expanded access uses). 58. id. 59. 21 c.f.r. § 312.310(d) (2018). 60. expanded access to investigational drugs for treatment use —questions and answers, guidance for industry, supra note 52 “in an emergency situation (either an emergency use ind or emergency use protocol) when there is not sufficient time to secure irb review prior to beginning treatment, the emergency use of the investigational drug must be reported to the irb within 5 working days of emergency use, as required under § 56.104(c).” id. at 8. further, “[a] physician submitting an individual patient expanded access ind using form fda 3926 may select the appropriate box on that form to request a waiver under § 56.105 of the requirements in § 56.108(c), which relate to full irb review. fda concludes that such a waiver is appropriate for individual patient expanded access inds when the physician obtains concurrence by the irb chairperson or 110 indiana health law review [vol. 16:101 treatment inds—for experimental drugs showing potential in clinical testing for serious or life-threatening conditions and conducted during the final clinical work and during fda review. once an ind is filed, several years transpire prior to full approval. however, there are programs that facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions are as follows:61 fast track which means unmet medical need must be established; priority review which means a six month review time period where no sufficient therapy exists; accelerated approval involving initial clinical trials disclose disease reduction and survival lengthened; and a breakthrough therapy designation which is part of fda safety and innovation act.62 v. federal primer—investigational mechanisms for medical devices investigational medical device exemptions and clinical trials the federal right-to-try act63 does not specifically include medical devices yet arguably perhaps it does in the preamble and was expressly incorporated in prior legislative proposals.64 nevertheless, it is noteworthy to, at a minimum, recognize investigational devices. similar to investigational drugs, investigational device exemptions (ide) permit the use of a device on human subjects in clinical another designated irb member before treatment use begins. a physician submitting an individual patient expanded access ind using form fda 1571 may include a separate waiver request with the application.” id. at 6. 61. fast track, breakthrough therapy, accelerated approval, priority review, u.s. food & drug admin., (feb. 23, 2018), https://www.fda.gov/forpatients/approvals/fast/default.htm [https://perma.cc/8hch-ntdc.] 62. food and drug administration safety and innovation act, pub. l. no. 112-144, 126 stat. 993 (2012) (codified as amended at 21 u.s.c.a. § 301(1938)). see also 21st century cures act, pub. l. no. 114-255, 130 stat. 1033 (2016) (which is intended to accelerate drug and medical device approvals). 63. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 64. the prior legislative history details that medical devices were included, however, the law passed does not address medical devices. see, e.g., right to try act of 2017, h.r. 878, 115th cong. (2017-2018) (requiring the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: “[1] intended to treat a patient who has been diagnosed with a terminal illness; and [2] authorized by . . . state law.” id.); see also 21 usc 360bbb-0 (b) (2017). in the preamble, of the right-to-try act, the term “medical product” is used. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017. pub. l. no. 115-176, 130 stat. 834 (2018). medical product is defined under 42 u.s. code § 287a. “the term ‘medical product’ means a drug, device, biological product, or product that is a combination of drugs, devices, and biological products.” 42 u.s.c. § 287a (a)(4) (2018). 2018] the latest “federal movement” in the food and drug law arena 111 trials.65 an approved ide stipulates the maximum amount of clinical sites and the maximum number of human subjects that may be enrolled in a study. fda has the authority to exempt investigational use devices from particular requirements that other devices must abide by.66 an approved ide application permits shipment of a device, otherwise subject to marketing clearance.67 an approved ide permits use in a clinical trial to gather safety and efficacy data necessary to substantiate some 510(k) submissions and for pma’s.68 clinical studies are a requisite for a pma and in some instances a 510(k) and require: an approved ide by an institutional review board (irb); informed consent from patients; labeling that details investigational use only; and records and reports.69 vi. expanded access to medical devices some patients might not be eligible for an investigational device clinical trial. fortunately, similar to investigational drugs, there are methods available to those patients who have a life-threatening disease for which there are no currently approved medical device treatments. these include emergency use, treatment use, and compassionate or humanitarian use, detailed below. a. emergency use of unapproved medical devices70 an unapproved device may provide the single potential life-saving alternative. however, what happens when there is no ide or perhaps the proposed use is not approved under an existing ide? additionally, the physician or institution may not be approved under the ide. fda will use enforcement discretion, if a physician utilizes an unapproved device on an emergency basis. fda prior approval is not required as long as the following criteria for emergency use are met: (1) the human subject is confronted by a life-threatening situation necessitating the use of the test article; (2) informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject; 65. 21 c.f.r. § 812 (2018). 66. id. 67. id. 68. id. 69. protection of human subjects, 21 c.f.r. § 50 (2018); financial disclosure by clinical investigators, 21 c.f.r. § 54 (2018); institutional review boards, 21 c.f.r. § 56 (2018); quality system regulation, design controls, 21 c.f.r. § 820(c) (2018). 70. exception from general requirements, 21 c.f.r. § 50.23(a) (2018). see also expanded access for medical devices, u.s. food & drug admin., https://www.fda.gov/medicaldevices/ deviceregulationandguidance/howtomarketyourdevice/investigationaldeviceexemptionide/ucm0 51345.htm [https://perma.cc/t53g-bbhe] (last updated sept. 25, 2018). 112 indiana health law review [vol. 16:101 (3) time is not sufficient to obtain consent from the subject’s legal representative; and (4) there is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.71 b. treatment use of investigational devices treatment use means that an ide trial may be expanded to include additional patients with life-threatening or serious diseases if the data indicates that the device is effective.72 the following parameters apply to treatment use of investigational devices:73 the device is intended to treat or diagnose a serious or immediately lifethreatening disease or condition; there is no comparable or satisfactory alternative device available to treat or diagnose the disease or condition in the intended patient population; the device is under investigation in a controlled clinical trial for the same use under an approved ide, or all clinical trials have been completed; and the sponsor of the controlled clinical trial is pursuing marketing approval/clearance of the investigational device with due diligence.74 c. humanitarian or compassionate use devices similar to human drugs, compassionate use devices75 provide an option for a patient that has a lifethreatening or serious disease or condition. a humanitarian device, (hud) also referred to as a compassionate use device, provides patients with a method to use an investigational device not yet approved. compassionate use devices provide a possible access to those investigational devices that have not received fda approval or clearance. further, the patient’s physician must be of the medical opinion the device may provide a benefit in treating or perhaps even diagnosing the disease or condition. compassionate use can be for patients who do not meet the requirements for inclusion in the clinical investigation and for devices that are in a clinical trial under an investigational device exemption.76 further, a compassionate use device may not be in a clinical investigation and is for a small group or an individual patient. the criteria include the following:77 the patient has a life-threatening or serious disease or condition; 71. exception from general requirements, 21 c.f.r. § 50.23(a) (2018). 72. treatment use of an investigational new device, 21 c.f.r. § 812.36 (2018). 73. id.; see also expanded access for medical devices, supra note 69. 74. expanded access for medical devices, supra note 69. 75. id. 76. id. 77. id. 2018] the latest “federal movement” in the food and drug law arena 113 no generally acceptable alternative treatment for the condition exists; and time is of essence which does not permit obtaining an investigational device exemption.78 submission of a humanitarian device exemption application is necessary, and the approval rate is approximately 99%.79 the federal right to try act does not address compassionate use for medical devices. 80 vii. fda action prior to the enactment of the federal right-to-try legislation as detailed above, despite state legislation, a patient who is ineligible to obtain an experimental therapy through a clinical trial has had the option to request experimental therapy through his or her physician to apply to the fda to obtain experimental therapy under expanded access or compassionate use. according to fda, expanded access or as indicated compassionate use is the “use of investigational drugs, biologics or medical devices outside the clinical trial setting for treatment purposes.”81 further, to determine the suitability for expanded access the following are all requisite:82 [the] patient has a serious disease or condition, or [his or her] life is immediately threatened by [the] disease or condition; [t]here is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; enrollment in a clinical trial is not possible; [any] potential patient benefit justifies [ or outweighs] the potential risks of treatment; [using] the investigational medical product will not [impede the] investigational trials that could support [the] . . . development or marketing approval for the treatment indication.83 all of the above parameters are straightforward. however, the issue becomes how to obtain the potentially life-extending product. perhaps that is why the state legislation84 and now the federal right to try act85 were enacted. following the introduction and passage of several state right-to-try laws, in 78. id. 79. id.; see also appendix ii. 80. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). the federal right to try act does not specifically include medical devices. perhaps intentional or perhaps an oversight yet medical devices should have been included. 81. expanded access (sometimes called “compassionate use”), supra note 45. 82. requirements for all expanded access uses, 21 c.f.r. § 312.305 (2018). 83. expanded access (sometimes called “compassionate use”), supra note 45. 84. goldwater inst., supra note 14. 85. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 114 indiana health law review [vol. 16:101 february of 2015, the fda released a proposed “streamlined” procedure for individual patient expanded access to experimental drugs.86 the fda published a final version on june 2, 2016, entitled “individual patient expanded access applications – form fda 3962”87, along with patient and physician information sheets and related guidances for all expanded access for experimental drugs and for charging for experimental drugs. conditions include that the possible patient benefit validates the potential risks, the risk from the investigational drug is less than that from the disease or condition, the use will not interfere with drug development, and the patient cannot access an existing clinical trial.88 the aim of revised form fda 3926 procedures is for clarity purposes.89 form fda 3926 was devised due to complaints about the prior forms, fda 1571 and 1572, which were used for all ind submission, being both inappropriate and too burdensome for physicians to complete for individual patient access.90 the revised procedure, which now also specifically applies to biologics, makes the application process easier for physicians; however, it relies on obtaining the agreement of the manufacturer/ind holder to provide the drug and to sign a letter of agreement (loa) to allow access to its ind submission (and to contact the fda when no loa can be obtained or in a situation with an rems), and retains the requirements for patient informed consent and irb approval.91 further, form 3926 is permitted for certain follow-up submissions.92 treatment may proceed 30 days after the fda receives the completed form fda 3926 unless earlier notification is provided or under an emergency request.93 there are followup responsibilities for the physician, now a sponsor-investigator.94 these fda procedures using form fda 3926 for individual expanded access are patient focused and streamlined.95 the state of maryland right-to-try act,96 is intended to provide terminally 86. u.s. dep’t of health & human servs., individual patient expanded access applications: form fda 3926 guidance for industry (2017), https://www.fda.gov/ downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm432717.pdf [https://perma.cc/nwz5-tagc]. 87. id. medical devices follow a separate pathway and are not included in this new guidance. the guidance provides that individual patient expanded access for drugs allows physicians to request access to investigational drugs outside of a clinical trial (or “for an approved drug where availability is limited by a risk evaluation and mitigation strategy (rems)”) for those individual patients who have serious or immediately life-threatening diseases or conditions where no other comparable or satisfactory treatment is available. id. 88. id. 89. id. 90. id. at 4. 91. id. at 6. 92. id. at 4. 93. id. at 7. 94. id. at 5. 95. see id.; see also app. iii. 96. see right to try act, md. code ann., health–gen. § 21-2b-01 (lexisnexis 2017). 2018] the latest “federal movement” in the food and drug law arena 115 ill patients, who do not have the luxury of waiting for what may be a lengthy fda approval process to be completed, with access to recommended experimental therapies, including drugs, biologics and medical devices, where a clinical trial is not available and currently approved and recognized treatment options are unlikely to prolong the patient’s life. like the fda expanded access or compassionate use procedure, the maryland right-to-try act97 relies on requests by physicians, patient informed consent, and the agreement of the manufacturer of the therapy in question to provide the therapy. even prior to the enactment of the federal right-to-try act, perhaps the related legislation in various states such as maryland provided the impetus to the fda to streamline its expanded access or compassionate use procedures for drugs and biologics.98 does the federal right-to-try act provide anything further than what fda has in place? perhaps the federal rightto-try act is merely a step further toward a sense of right-to-request by the patient.99 optimistically, these laws increase the awareness of patients and physicians regarding state and federal procedures to obtain experimental therapies. it is important to remember though that both state and fda procedures rely on the willingness of manufacturers to provide access to drugs, biologics, or perhaps devices upon request and insurers to pay. section 3 in the federal right-to-try act is of particular note.100 sense of the senate of the federal right-to-try act which provides as follows: sec. 3. sense of the senate. it is the sense of the senate that section 561b of the federal food, drug, and cosmetic act, as added by section 2— (1) does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual (emphasis added); (2) does not establish any new mandates, directives, or additional regulations; (3) only expands the scope of individual liberty and agency among patients, in limited circumstances; (4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the food and drug administration101 (emphasis added); 97. id.; see also app. v. 98. id. 99. roseann b. termini & janet m. lis, ‘right-to-try’ or ‘right-to-ask’? do state right-totry laws offer an answer for terminally ill patients seeking access to investigational therapies?, 38 pa. law. 45 (2016) (authors conclude “right-to-ask” provides autonomy). 100. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 101. see, e.g., expanded access (sometimes called “compassionate use”), supra note 80. 116 indiana health law review [vol. 16:101 (5) will not, and cannot, create a cure or effective therapy where none exists; (6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561a involves an informed assumption of risk; and (7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients.102 the alternative pathway is that of expanded access discussed above. again, a patient who is ineligible to obtain an experimental therapy through a clinical trial could request that his or her physician apply to the fda to obtain an experimental therapy commonly known as compassionate use procedures. the fda approval rate for expanded access or compassionate use therapy is 99 percent.103 one question that remains unanswered is whether physicians and patients are aware of the federal expanded access or compassionate use mechanism already in place. another issue is whether physicians are willing to expend the considerable time and effort needed to pursue expanded access. viii. proactive solutions and recommendations the intent of the federal right-to-try act is not to undermine fda authority. rather the intent is to provide an individual patient with the “liberty”104 to request a potentially life-saving therapy.105 however, the following are recommended actions to comport with the intent of the federal right-to-try act: • the fda and the health care industry should utilize a collaborative approach to ensure awareness of the expanded or “compassionate” use program in place at fda. • congress should amend the federal right-to-try act to expressly address what was not clarified in the current federal right-to-try act such as medical devices,106 medical foods107 and perhaps dietary 102. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 103. see jennifer e. miller, joseph s. ross, kenneth i. moch & arthur l. caplan, characterizing expanded access and compassionate use programs for experimental drugs, 10 biomed cent. res. notes 350 (2017) https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5534121/ [https://perma.cc/kj3g-f5aq]. see also app. i. 104. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 105. 164 cong. rec. h43,55-66 (daily ed. may 22, 2018); trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018) (“[i]t is the sense of the senate that section 561b of the federal food, drug and cosmetic act, as added by section 2. . . (4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the food and drug administration.”) 106. the prior legislative history details that medical devices were included; however, the law passed does not address medical devices. see, e.g., right to try act, h.r. 878, 115th cong. (20172018] the latest “federal movement” in the food and drug law arena 117 supplements for the desperately ill who have a life threatening condition(s).108 • include medical devices through deeming or by amendment.109 • congress should amend the federal right-to-try act or by delegation to fda, should specify that an advocate be appointed for the patient. • congress could amend the federal right-to-try act or by delegation should provide clarity about those involved in the process so that a patient understands that the sponsor manufacturer, prescriber, dispenser or other individual entity110 can deny access by not providing the requested therapy as well as understand the limitation as to liability and institute a legal action.111 • terminology—the federal-right-to-try act112 correctly references eligible patient yet should use the consistent terminology throughout for uniformity purposes such as life-threatening and terminally ill which 2018) (as introduced in the house on feb. 6, 2017) (this bill requires the “[t]he federal government shall not take any action to prohibit or restrict—(1) the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that—(a) is intended to treat a patient who has been diagnosed with a terminal illness; and (b) is authorized by, and in accordance with, state law . . .”). 107. the term “medical food”, as defined under the federal, food, drug and cosmetic act, means “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” 21 u.s.c. § 360ee(b)(3) (2018). 108. see dietary supplement health and education act of 1994, pub. l. no. 103-417, 108 stat. 4325 (fda regulates dietary supplements post-market and unlike drugs and some medical devices there is no pre-approval of dietary supplements.). 109. see deeming tobacco products to be subject to the federal food, drug, and cosmetic act, as amended by the family smoking prevention and tobacco control act; restrictions on the sale and distribution of tobacco products and required warning statements for tobacco products, 81 fed. reg. 28973 (may 10, 2016) (to be codified at 21 cfr pt. 1100, 21 cfr pt. 1140, and 21 cfr pt. 1143) (as an analogy and example of deeming regulations, fda issued deeming regulations which extends fda’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels. the final rule deems products “meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the federal food, drug, and cosmetic act (the fd&c act), as amended by the family smoking prevention and tobacco control act (tobacco control act).” id.). 110. 164 cong. rec. h43,56 (daily ed. may 22, 2018) (§ 561b(b)(2) determination not to provide drug). 111. id. at § 561b(b) no liability. 112. the federal-right-to-try act, uses the term “terminal illness” and “eligible patient” in sec. 2. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 118 indiana health law review [vol. 16:101 could be accomplished by a technical amendment.113 • informed consent-perhaps congress should review and expand on informed consent as addressed in the maryland right-to-try act as it is comprehensive and patient centered.114 ix. final commentary-overall benefit of right-to-try the federal right-to-try act, fda’s expanded access procedures known as compassionate use procedures as well as state right-to-try laws may more properly be seen as providing a right-to-request.115 both the federal right-to-try act and the state right-to-try laws do appear to be raising the awareness of the potential use of and empowering desperately ill patients to request experimental therapies.116 for example, as detailed above, the fda revised form 3926 streamlines the process in obtaining fda approval for compassionate use.117 what is most critical at this junction is to ensure a user-friendly approach to navigate the system to obtain an experimental therapy for an individual human being. it is uncertain, however, if the state right-to-try laws are effective in accessing experimental therapies or whether any eventual access is actually obtained through fda procedures, and whether the state laws can stand in relation to the existing federal right-to-try118 authority and principles of preemption.119 however, when patients do request experimental therapies they must be counseled on the process involved, all potentially available mechanisms, of the possibility that they may not receive the experimental therapy, the potential 113. see generally 21 c.f.r. § 312.81 (2018). (“this section applies to new drug and biological products that are being studied for their safety and effectiveness in treating lifethreatening or severely-debilitating diseases.(a) for purposes of this section, the term ‘lifethreatening’ (emphasis added) means: (1) diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and (2) diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival (b) for purposes of this section, the term ‘severely debilitating’ means diseases or conditions that cause major irreversible morbidity. (c) sponsors are encouraged to consult with fda on the applicability of these procedures to specific products.”). 114. md. code ann., health-gen. § 21-2b (west) 115. termini & lis, supra note 97, at 45. 116. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). see also expanded access (sometimes called “compassionate use”), supra note 45. 117. the revised form fda 3926 is less complicated and provides a streamlined process for submission to fda. see u.s. dep’t of health & human servs., supra note 85. app. iii for the timeline specifications. 118. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 119. id. yet, arguably, since the federal right-to-try does not expressly cover medical devices, state right-to-try could prevail and provide a mechanism for experimental treatment in that regard. 2018] the latest “federal movement” in the food and drug law arena 119 risks, the costs involved, and the limitation of the right to institute a lawsuit. finally, as indicated, there is no simple definitive solution. yet, perhaps the state right-to-try initiatives and now the federal right-to-try act,120 albeit with realistic hope, may serve a valuable substantive purpose by providing a method for patients to assert their desires and needs, to foster autonomy, to further their self-determination for their health care , and above all to maintain their human dignity. 120. id. 120 indiana health law review [vol. 16:101 x. appendices a. appendix i: expanded access inds fy 2012-2017121 expanded access inds 121. expanded access inds and protocols 2009-2017, supra note 52; ind investigational new drug application, u.s. food & drug admin., https://www.fda.gov/drugs/development approvalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdr ugindapplication/default.htm [https://perma.cc/ga7y-74lz] (last updated oct. 5, 2017). 2018] the latest “federal movement” in the food and drug law arena 121 a. appendix i: expanded access inds fy 2012-2017 (cont’d) expanded access inds these reporting periods cover a one-year cohort starting the day the final rule for expanded access to investigational drugs for treatment use and charging for investigational drugs went into effect. starting with fiscal year 2012, the reporting period was changed to a fiscal year to match the reporting period for other ind activity reports. 122 indiana health law review [vol. 16:101 b. appendix ii122 compassionate use ide supplements year total submissions evaluable submissions* percent approved** 2012 135 123 99.19% 2013 181 175 98.86% 2014 228 216 99.54% 2015 215 208 99.04% *excludes those withdrawn or converted to emergency use while under review **based on evaluable submissions compassionate use requests without an ide year total submissions evaluable submissions* percent approved** 2012 53 53 98.11% 2013 138 134 91.79% 2014 112 101 99.01% 2015 170 167 98.80% *excludes those withdrawn or converted to emergency use while under review **based on evaluable submission 122. expanded access for medical devices, supra note 69. 2018] the latest “federal movement” in the food and drug law arena 123 c. appendix iii123 individual patient expanded access ind application for emergency use: initial submission time action supporting documentation day 0-1 contact sponsor/manufacturer to obtain their agreement to provide expanded access to the investigational drug letter of authorization from sponsor/manufacturer granting a right of reference to the information contained in their existing ind • letter of authorization (see online template) to be sent to fda at the time of application submission by day 15 day 1 call fda to obtain fda authorization for the expanded access use information will be requested by the fda representative and can be provided via phone, fax, or e-mail day 1 obtain informed consent from patient or their legally authorized representative prior to administering treatment posttreatment by day 5 notify institutional review board (irb) of the emergency expanded access use supporting documentation as required by the respective applicable irb 123. emergency ind timeline, u.s. dep’t of health & human servs., https://www.fda. gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalappl ications/investigationalnewdrugindapplication/ucm597130.htm [https://perma.cc/d6qmaymh] (last updated feb. 20, 2018). 124 indiana health law review [vol. 16:101 by day 15 submit the expanded access ind application to the appropriate review division in the center for drug evaluation and research (cder) at fda insert your ind number, provided to you by fda staff, in the appropriate section of the application form (e.g., section titled, physician’s ind number in section 3 of form fda 3926) form fda 39261 letter of authorization2 from sponsor/manufacturer 1 form fda 1571 and 1572 are also accepted, however, form fda 3926 is a streamlined form created specifically for individual patient ind submissions, including those for emergency use. 2 in the absence of a letter of authorization from the sponsor/manufacturer, the expanded access ind application’s sponsor is responsible for providing the following in the ind application submission: • description of the facility where the drug is manufactured; • chemistry, manufacturing, and controls information adequate to ensure the proper identification, quality, purity, and strength of the investigational drug; • pharmacology and toxicology information adequate to conclude that the drug is reasonably safe at the dose and duration proposed for the emergency use. d. appendix iv federal right to try124 to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law, and for other purposes. be it enacted by the senate and house of representatives of the united states of america in congress assembled, section 1. short title. this act may be cited as the “trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017”. sec. 2. use of unapproved investigational drugs by patients diagnosed with a terminal illness. (a) in general.—chapter v of the federal food, drug, and cosmetic act is amended by inserting after section 561a (21 u.s.c. 360bbb–0) the following: 124. trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try act of 2017, pub. l. no. 115-176, 132 stat. 1372 (2018). 2018] the latest “federal movement” in the food and drug law arena 125 “sec. 561b. investigational drugs for use by eligible patients. “(a) definitions.—for purposes of this section— “(1) the term ‘eligible patient’ means a patient— “(a) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, code of federal regulations (or any successor regulations)); “(b) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— “(i) is in good standing with the physician’s licensing organization or board; and “(ii) will not be compensated directly by the manufacturer for so certifying; and “(c) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent; “(2) the term ‘eligible investigational drug’ means an investigational drug (as such term is used in section 561)— “(a) for which a phase 1 clinical trial has been completed; “(b) that has not been approved or licensed for any use under section 505 of this act or section 351 of the public health service act; “(c) (i) for which an application has been filed under section 505(b) of this act or section 351(a) of the public health service act; or “(ii) that is under investigation in a clinical trial that— “(i) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this act or section 351 of the public health service act; and “(ii) is the subject of an active investigational new drug application under section 505(i) of this act or section 351(a)(3) of the public health service act, as applicable; and 126 indiana health law review [vol. 16:101 “(d) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and “(3) the term ‘phase 1 trial’ means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, code of federal regulations (or any successor regulations). “(b) exemptions.—eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of this act, section 351(a) of the public health service act, and parts 50, 56, and 312 of title 21, code of federal regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, code of federal regulations (or any successor regulations) that apply to investigational drugs. “(c) use of clinical outcomes.— “(1) in general.—notwithstanding any other provision of this act, the public health service act, or any other provision of federal law, the secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 505 of this act or section 351 of the public health service act unless— “(a) the secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or “(b) the sponsor requests use of such outcomes. “(2) limitation.—if the secretary makes a determination under paragraph (1)(a), the secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug. “(d) reporting.— “(1) in general.—the manufacturer or sponsor of an eligible investigational drug shall submit to the secretary an annual summary of any use of such drug under this section. the summary shall include the number of doses supplied, the 2018] the latest “federal movement” in the food and drug law arena 127 number of patients treated, the uses for which the drug was made available, and any known serious adverse events. the secretary shall specify by regulation the deadline of submission of such annual summary and may amend section 312.33 of title 21, code of federal regulations (or any successor regulations) to require the submission of such annual summary in conjunction with the annual report for an applicable investigational new drug application for such drug. “(2) posting of information.—the secretary shall post an annual summary report of the use of this section on the internet website of the food and drug administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was— “(a) used in accordance with subsection (c)(1)(a); “(b) used in accordance with subsection (c)(1)(b); and “(c) not used in the review of an application under section 505 of this act or section 351 of the public health service act.”. (b) no liability.— (1) alleged acts or omissions.—with respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561b of the federal food, drug, and cosmetic act and in compliance with such section, no liability in a cause of action shall lie against— (a) a sponsor or manufacturer; or (b) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable state law. (2) determination not to provide drug.—no liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561b of the federal food, drug, and cosmetic act. (3) limitation.—except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any state or federal product liability, tort, consumer protection, or warranty law. 128 indiana health law review [vol. 16:101 sec. 3. sense of the senate. it is the sense of the senate that section 561b of the federal food, drug, and cosmetic act, as added by section 2— (1) does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual; (2) does not establish any new mandates, directives, or additional regulations; (3) only expands the scope of individual liberty and agency among patients, in limited circumstances; (4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the food and drug administration; (5) will not, and cannot, create a cure or effective therapy where none exists; (6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561a involves an informed assumption of risk; and (7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients. e. appendix v: maryland as an example of state right to try legislation125 title 21. food, drugs, and cosmetics > subtitle 2b. right to try act. (a) in general. - in this subtitle the following words have the meanings indicated. (b) carrier. - “carrier” has the meaning stated in § 15-10a-01(c) of the insurance article. (c) eligible patient. - “eligible patient” means an individual who: (1) has a terminal illness, attested to by the individual’s treating physician; (2) has considered all other treatment options currently approved by the united states food and drug administration; (3) has received a recommendation from the individual’s treating physician for the use of an investigational drug, biological product, or device; (4) (i) has given informed consent for the use of the investigational 125. md. code ann., health–gen. § 21-2b01 (lexisnexis 2018) 2018] the latest “federal movement” in the food and drug law arena 129 drug, biological product, or device; or (ii) if the individual is a minor or lacks the mental capacity to provide informed consent, has a parent or legal guardian who has given informed consent on the individual’s behalf for the use of the investigational drug, biological product, or device; (5) is ineligible for or unable to participate in a clinical trial; and (6) has documentation from the individual’s treating physician that the individual meets the requirements of items (1) through (5) of this subsection. (d) health occupations board. - “health occupations board” means a board established under the health occupations article that issues licenses to practice a health occupation in the state. (e) informed consent. - “informed consent” means a written document prepared using the informed consent form developed by the office of the attorney general in accordance with § 21-2b-02(d)(1) of this subtitle that: (1) is signed by the patient or a parent or legal guardian of the patient; (2) is attested to by the patient’s treating physician and a witness; and (3) at a minimum: (i) explains the currently approved products and treatments for the disease or condition from which the patient suffers; (ii) attests to the fact that the patient concurs with the patient’s treating physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life; (iii) identifies clearly the specific proposed investigational drug, biological product, or device that the patient is seeking to use; (iv) informs the provider and eligible patient of any known or anticipated side effects, risks, or reported patient discomfort that is likely related to the treatment; (v) describes the best and worst potential outcomes of using the investigational drug, biological product, or device with a realistic description of the most likely outcome, including the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment, based on the treating physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition; (vi) makes clear that the patient’s carrier and health care provider are not obligated to pay for any care or treatments that are necessary as a result of the use of the investigational drug, biological product, or device except as required by federal or state law or contract; (vii) makes clear that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements; and (viii) states that the patient understands that the patient may be 130 indiana health law review [vol. 16:101 liable for all expenses relating to the use of the investigational drug, biological product, or device and that this liability extends to the patient’s estate, but not the heirs or legatees of the patient. (f) investigational drug, biological product, or device. - “investigational drug, biological product, or device” means a drug, biological product, or device that: (1) has successfully completed phase i of a clinical trial but has not yet been approved for general use by the united states food and drug administration; and (2) remains under investigation or in a clinical trial approved by the united states food and drug administration. (g) terminal illness. - “terminal illness” means a disease or condition that, without life-sustaining procedures, will result in death or a state of permanent unconsciousness from which recovery is unlikely within 12 months. f. appendix vi126 individual patient expanded access ind application for emergency use: initial submission time action supporting documentation day 0-1 contact sponsor/manufacturer to obtain their agreement to provide expanded access to the investigational drug letter of authorization from sponsor/manufacturer granting a right of reference to the information contained in their existing ind • letter of authorization (see online template) to be sent to fda at the time of application submission by day 15 day 1 call fda to obtain fda authorization for the expanded access use information will be requested by the fda representative and can be provided via phone, fax, or e-mail day 1 obtain informed consent from patient or their legally authorized representative prior to administering treatment 126. emergency ind timeline, supra note 123. 2018] the latest “federal movement” in the food and drug law arena 131 posttreatment by day 5 notify institutional review board (irb) of the emergency expanded access use supporting documentation as required by the respective applicable irb by day 15 submit the expanded access ind application to the appropriate review division in the center for drug evaluation and research (cder) at fda insert your ind number, provided to you by fda staff, in the appropriate section of the application form (e.g., section titled, physician’s ind number in section 3 of form fda 3926) form fda 39261 letter of authorization2 from sponsor/manufacturer form fda 1571 and 1572 are also accepted, however, form fda 3926 is a streamlined form created specifically for individual patient ind submissions, including those for emergency use. in the absence of a letter of authorization from the sponsor/manufacturer, the expanded access ind application’s sponsor is responsible for providing the following in the ind application submission: • description of the facility where the drug is manufactured; • chemistry, manufacturing, and controls information adequate to ensure the proper identification, quality, purity, and strength of the investigational drug; • pharmacology and toxicology information adequate to conclude that the drug is reasonably safe at the dose and duration proposed for the emergency use. section 1. short title. (a) in general.—chapter v of the federal food, drug, and cosmetic act is amended by inserting after section 561a (21 u.s.c. 360bbb–0) the following: “sec. 561b. investigational drugs for use by eligible patients. (b) no liability.— sec. 3. sense of the senate. teamwork makes the scheme work: state licensure verification for national provider identifier applicants anthony singer* i. introduction david williams has exposed a weakness in the american health insurance system. on october 12, 2017, a texas man, david williams, was arrested on a charge of felony health care fraud, punishable by up to ten years in prison and a $250,000 fine.1 seven months later, he was convicted after a two-day trial, and the charges had quadrupled. over the course of four years, williams had applied for and acquired at least twenty national provider identifiers (“npis”) from the centers for medicare and medicaid services (“cms”).2 the npi is a unique, tendigit identification number that health care providers and health plans “must use . . . in the administrative and financial transactions adopted under hipaa.”3 to apply for an npi, providers must submit personal details such as their social security number, personal and business addresses, and licensure information.4 david williams, who held a ph.d. in kinesiology and operated a personal training business, but is neither a physician nor licensed to practice any of the professions eligible to receive an npi, falsely certified on his applications that he was a licensed physician who practiced sports medicine.5 williams’ deception, however, was not as difficult as one might imagine. a federal prosecutor noted that cms “relies on the honesty of [npi] applicants”6 * j.d. & m.p.h. candidate, 2021, indiana university robert h. mckinney school of law & richard m. fairbanks school of public health; b.a., 2017, indiana university. many thanks to professor dan orenstein for his advice and support throughout the development of this note. 1. ryan osborne, fort worth trainer ‘dr. dave’ accused of $25 million health care fraud, fort worth star-telegram (oct. 13, 2017), https://www.star-telegram.com/news/ local/fort-worth/article178779236.html [https://perma.cc/6ln8-rsbr]. 2. marshall allen, senators call for closing “loopholes” that make health care fraud easy, propublica (aug. 14, 2019), https://www.propublica.org/article/senators-call-for-closingloopholes-that-make-health-care-fraud-easy [https://perma.cc/7gtl-erkz] [hereinafter allen, loopholes]. 3. national provider identifier standard (npi), ctr. for medicare & medicaid serv., h t tps:/ /www.cms.gov/regulat ions-and-guidance/administrat ive-simplif icat ion / nationalprovidentstand/ [https://perma.cc/76sh-8m83] (last updated may 15, 2018). 4. national provider identifier (npi) application/update form, ctr. for medicare & medicaid serv., https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms 10114.pdf [https://perma.cc/egj3-22zg] (last visited feb. 21, 2021). 5. marshall allen, health insurers make it easy for scammers to steal millions. who pays? you., propublica (july 19, 2019), https://www.propublica.org/article/health-insurers-make-iteasy-for-scammers-to-steal-millions-who-pays-you [https://perma.cc/u5e2-4pes] [hereinafter allen, scammers]. 6. id. 418 indiana health law review [vol. 18:417 and does not verify the submitted information,7 and cms only verifies the credentials of those who enroll to provide care to medicare and medicaid patients.8 using his npis, williams was able to bill insurers aetna, cigna, and united healthcare to the tune of $25 million for providing personal training services, posing as an out-of-network provider and hoping that the insurers would not bother to investigate.9 upon his conviction, in addition to a sentence of approximately nine years in federal prison, the judge ordered that williams pay the entire sum that he received from the insurers in restitution, a total of nearly $4 million.10 david williams is not the only person to obtain npis under false pretenses and use them to fraudulently bill insurers; there have been other cases investigated recently in which non-licensed clinic administrators acquired npis using false information and used them to bill millions in claims.11 the cost of this kind of health insurance fraud tends to be passed along to consumers through increased premiums, copays, and deductibles or reductions in benefits, which reduces the stakes of fraud for insurers and disincentivizes the development of sound preventative or investigative measures.12 cms acknowledged that it did not verify certain information submitted as part of an npi application, including whether an applicant is licensed to practice medicine, and the agency claimed that it needed “explicit authority” from the department of health and human services (“hhs”) in order to verify such information.13 in august 2019, marshall allen’s initial article on david williams and his fraud14 prompted six u.s. senators to write a letter to the hhs secretary, alex azar, and the administrator of cms, seema verma, to request information 7. there are some exceptions to this. see hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3434 (jan. 23, 2004) (“as health care provider data are entered into the nps from the application, the nps will check the data for consistency, standardize addresses, and validate the social security number (ssn) if the individual applying for an npi provides it; the nps will validate the date of birth only if the ssn is validated . . . . if problems [with the applicant’s information] are not encountered, the nps will then search its database to determine whether the health care provider already has an npi. if a health care provider has already been issued an npi, an appropriate message will be communicated. if not, an npi will be assigned.”). 8. allen, scammers, supra note 5. 9. press release, u.s attorney’s office for the n. dist. of tex., fort worth man convicted of health care fraud scheme (may 24, 2018), https://www.justice.gov/usao-ndtx/pr/fort-worthman-convicted-health-care-fraud-scheme [https://perma.cc/kx55-en5z]; see also id. 10. allen, scammers, supra note 5. 11. id. 12. marshall allen, we asked prosecutors if health insurance companies care about fraud. they laughed at us., propublica (sept. 10, 2019), https://www.propublica.org/article/weasked-prosecutors-if-health-insurance-companies-care-about-fraud-they-laughed-at-us [https://perma.cc/az3h-27fd] [hereinafter allen, prosecutors]. 13. allen, scammers, supra note 5. 14. id. 2021] teamwork makes the scheme work 419 on cms’s efforts to improve the agency’s ability to prevent and investigate fraud.15 as of march 2020, there had been no response from the administration. david williams exposed a gap in the american health insurance system, and due to its ripeness for fraudulent action, that gap needs to be addressed, and the appropriate adjustment is licensure verification for npi applicants by cms. section ii of this note explores the federal government’s efforts to improve the efficiency of health care in the face of technological change and the npi’s place in those efforts. section iii examines the regulatory standard that hhs must meet in order to assign npis, argues that the hhs interpretation of these regulations does not deserve deference, illustrates the standard in a recognizable manner, and determines that hhs is not meeting the standard. section iv describes the practicality of adjusting the nps application process to meet the regulatory standard. section v surveys the federal policymaking landscape to determine the likelihood of meaningful action on this issue in the immediate future. ii. hipaa, administrative simplification, and the npi the npi’s purpose was to simplify the administration of health care and improve the efficiency of health information transmission. individual health plans, be they administered by government or by private entities, are used to assign identification numbers to providers and suppliers in their networks, and these identification numbers often were not standardized within plans nor were they standardized across health plans, resulting in confusion and complication when claims were submitted and processed.16 as this chaos was unfolding, the growing adoption of computers in the workplace meant that businesses were able to store ever-larger amounts of data, thereby compounding the potential for mistakes. the use of computers for recordkeeping purposes proliferated throughout many institutions of american life—especially government17—during the latter half of the 20th century, but the health care industry lagged behind. as 15. letter from catherine cortez masto, u.s. sen., nev.; sheldon whitehouse, u.s. sen., r.i.; margaret wood hassan, u.s. sen., n.h.; tammy duckworth, u.s. sen., ill.; michael f. bennet, u.s. sen., colo.; & robert menendez, u.s. sen., n.j., to alex azar, secretary, u.s. dep’t of health & human servs., & seema verma, admin., ctrs. for medicare & medicaid servs. (aug. 12, 2019), https://www.cortezmasto.senate.gov/imo/media/doc/20190812cms%20medicare% 20fraud.pdf [https://perma.cc/9aph-5uk9]. 16. national standard health care provider identifier, 63 fed. reg. 25320, 25321 (may 7, 1998). 17. in 1975, a federal government survey of personal data systems subject to the privacy act of 1974 showed that approximately twenty-seven percent of systems were at least partially computerized. by 1985, the proportion of at least partially computerized personal data systems had risen to sixty percent; among large data systems, the figure was nearly eighty percent. office of tech. assessment, u.s. congress, federal government information technology: electronic record systems and individual privacy 22 (1986), https://www.princeton.edu/ ~ota/disk2/1986/8606/8606.pdf [https://perma.cc/l8qq-4awe]. 420 indiana health law review [vol. 18:417 physicians bemoaned the “inadequacies” of paper records,18 the institute of medicine (“iom”), while acknowledging some strengths of paper records,19 advocated for the adoption of computerized recordkeeping: first as a supplement to paper records in order to ease the transition and then, eventually, as an outright replacement.20 however, this endorsement of technological advancement, welcome though it was, did not arrive until 1997. a few years earlier, the government—surprisingly or unsurprisingly, depending on one’s view—had already taken steps to prepare the health care industry for the era of computerized recordkeeping. in 1991, aiming to improve efficiency in health care and hoping to capitalize on advances in technology, then-hhs secretary louis sullivan brought together leaders from across the industry to discuss potential solutions to administrative waste.21 a number of groups were born as a result of this summit, including the work group on administrative costs and benefits, the task force on patient information, and the work group for electronic data interchange (“wedi”).22 in 1993, cms,23 in collaboration with wedi and other representatives from the public and private sectors,24 began the development of an identifier, initially, for health care providers who participated in medicare, though the actual implementation of the identifier—the npi—and its accompanying system—the 18. steven m. ornstein et al., the computer-based medical record: current status, 35 j. fam. prac. 556, 556-58 (1992). 19. the iom’s report cited, as reasons for paper’s staying power as the standard medium for recordkeeping in many health care settings, paper records’ familiarity, portability (a moot consideration given modern technology), accessibility, and flexibility. comm. on improving the patient record, inst. of med., the computer-based patient record: an essential technology for health care 58 (1997). 20. id. at 178-79. 21. denise c. andresen, the computerization of health care: can patient privacy survive?, 26 j. health & hosp. l. 1, 1 (1993). 22. id. 23. at the time, the agency was known as the health care financing administration (“hcfa”). the name changed to the centers for medicare and medicaid services in june 2001 to accompany major reforms to the agency’s structure in order to better align with the services it was charged with administering. see sheila burke & elaine c. kamarck, the crisis in management at the centers for medicare and medicaid services (part i): capacity, brookings (mar. 2016), https://www.brookings.edu/wp-content/uploads/2016/07/cms-crisis-in-management-part-i.pdf [https://perma.cc/qnc6-977y]; press release, dep’t of health & human servs., the new centers for medicare and medicaid services (june 14, 2001), http://cdn.ca9.uscourts.gov/datastore/ library/2013/02/26/providence_pressrelease.pdf [https://perma.cc/kf8c-tf4w]; tommy g. thompson, sec’y, dep’t of health & human servs., remarks at press conference announcing reforming medicare and medicaid agency (june 14, 2001), https://wayback.archive-it.org/3926/ 20131029133134/http://archive.hhs.gov/news/press/2001pres/20010614b.html [https://perma.cc/ 4ntx-g8mk]. 24. for the list in full, see national standard health care provider identifier, 63 fed. reg. 25320, 25321 (may 7, 1998). 2021] teamwork makes the scheme work 421 national provider system (“nps”)—ultimately expanded to encompass providers not enrolled in medicare.25 these efforts all occurred prior to the enactment of the health insurance portability and accountability act of 1996 (“hipaa”), which required that the hhs secretary “adopt standards providing for a standard unique health identifier for each individual, employer, health plan, and health care provider for use in the health care system,” taking into account “multiple uses for identifiers and multiple locations and specialty classifications for health care providers.”26 hipaa’s “standard unique health identifier” requirement was one part of a broader goal of “administrative simplification,” wherein the law “encourage[d] the development of a health information system through the establishment of standards and requirements for the electronic transmission of certain health information.”27 to fulfill the requirements laid out in hipaa, cms proposed in 1998 the implementation of the npi, an eight-position alphanumeric identifier that carried no “intelligence”—in other words, nothing about the eight individual symbols that made up the npi nor the order in which those symbols were arranged conveyed information about the provider to whom it was assigned—and reserved the eighth position as a check digit, allowing for approximately twenty billion possible npis.28 in order for the npi to achieve designation as a hipaa standard, cms used ten principles, specified within hipaa and comporting with the standards set by the paperwork reduction act of 199529 and executive order 12866,30 to guide the development and implementation of the npi—principles such as efficiency, consistency, and flexibility.31 using these criteria,32 cms explored the possibility of using other identifiers—some specific to the health care industry33 or others 25. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3434 (jan. 23, 2004). 26. health insurance portability and accountability act of 1996, pub. l. no. 104-191, § 1173(b)(1), 110 stat. 1936, 2025. 27. id. at 2021. 28. national standard health care provider identifier, 63 fed. reg. at 25322. 29. paperwork reduction act of 1995, pub. l. no. 104-13, § 2, 109 stat. 163, 163-64. the act is intended to "strengthen the partnership between the federal government and state, local, and tribal governments by minimizing the burden and maximizing the utility of information created, collected, maintained, used, disseminated, and retained by or for the federal government," as well as “minimize the cost to the federal government of the creation, collection, maintenance, use, dissemination, and disposition of information.” 44 u.s.c. § 3501 (2021). 30. exec. order no. 12866, 58 fed. reg. 51735, 51735-36 (oct. 4, 1993). the executive order requires that agencies submit significant regulatory actions to the office of information and regulatory affairs for review. 31. national standard health care provider identifier, 63 fed. reg. at 25323-24. 32. for a full list with explanations for each criterion, see id. at 25329. 33. examples include the unique physician identification number (cms/hcfa); the health industry number (health industry business communications council); the national association of boards of pharmacy number; drug enforcement administration number; and the national 422 indiana health law review [vol. 18:417 with less of a tie to the field34—and ultimately eschewed their use in favor of the npi due to its satisfaction of the selected criteria. the npi’s proposed use was to universally identify, without confusion or complication, all types of health care providers who transmit certain health care information electronically,35 and while this did include means likely considered rather low-tech today36—or even at the time cms had included them—the agency seemed to have one eye trained on the future and the immense possibilities available there as the internet grew and developed.37 as cms continued to develop the npi and nps from 1998 to 2004, the npi grew to a ten-position numeric identifier,38 ultimately deciding against the use of alpha characters due to concerns over accessibility and accuracy, thus reducing the number of issuable npis from twenty billion to two hundred million—enough to last approximately two hundred years, according to cms projections.39 therefore, the npi facilitates universal identification of health care providers and improves the efficiency of health information transmission, thus simplifying the administration of health care. the npi not only simplifies the administration of health care but also supplier clearinghouse number (medicare). 34. social security number (social security administration) and the employer identification number (internal revenue service). 35. for a full list of the appropriate uses of the npi originally proposed by cms, see national standard health care provider identifier, 63 fed. reg. at 25334. 36. id. (“electronic transmissions would include transmissions using all media, even when the transmission is physically moved from one location to another using magnetic tape, disk, or cd media. transmissions over the internet (wide-open), extranet (using internet technology to link a business with information only accessible to collaborating parties), leased lines, dial-up lines, and private networks are all included.”). 37. compare susannah fox, the internet circa 1998, pew res. ctr. (june 21, 2007), https://www.pewinternet.org/2007/06/21/the-internet-circa-1998/ [https://perma.cc/4w42-dr7l], and cheri paquet, report counts 147 million global net users, cnn (feb. 12, 1999), http://edition.cnn.com/tech/computing/9902/12/globalnet.idg/index.html [https://perma.cc/3algk2na], with internet/broadband fact sheet, pew res. ctr. (june 12, 2019), https://www. pewinternet.org/fact-sheet/internet-broadband/ [https://perma.cc/h569-hnr7]. see also e-rate schools & libraries usf program, u.s. fed. comm. commission, https://www.fcc.gov/general/erate-schools-libraries-usf-program [https://perma.cc/36nz-du2w] (last visited oct. 5, 2019) (describing federal efforts to improve internet access); tim berners-lee, web access is a 'basic human right,' huffington post, https://www.huffingtonpost.co.uk/2014/12/12/web-humanright_n_6313688.html?guccounter=1&guce_referrer=ahr0chm6ly93d3cuz29vz2xllmnvbs 8&guce_referrer_sig=aqaaae4-9-i4sg7sr8ppqrvdrkgcybdkmqdki7yjqz45s ejfcvqycxhzltjxnlnrnoaxw58aihmwipbb5qsurj7hq4fmz3nfnmhorehfoxlfgb98st _zfraroivhmk6n-fgd8tokm5i6fbiecyuwqin4ky-sgiiup2tybaqjoycdxmqf [https://perma.cc/5bn9-mvl2] (last updated dec. 12, 2014). 38. 45 c.f.r. § 162.406 (2021). 39. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3442 (jan. 23, 2004). 2021] teamwork makes the scheme work 423 represents the simplest means of accessing health insurers’ coffers. when propublica reporter marshall allen described the npi as the “key that unlocks access to health care dollars,” cms disputed this characterization as a blunt exaggeration.40 recall, though, that “[c]overed health care providers and all health plans and health care clearinghouses must use the npis in the administrative and financial transactions adopted under hipaa.”41 even though cms and many private insurers verify a provider’s credentials before granting admission to their networks, out-of-network providers42 can still tap into those private insurance dollars since insurers will pay them for submitted claims without verifying the credentials of the provider billing them,43 thus creating a comfortable space within which bad actors can operate by taking advantage of cms’s reliance on honesty and private insurers’ indifference to fraud and waste. from 2010 to 2016, the percentage of patients with private insurance admitted to emergency departments at hospitals within their network and who received bills from out-ofnetwork providers increased from 32.3 percent to 42.8 percent; for in-patient admissions, the increase was sharper—from 26.3 percent to 42.0 percent. these increases meant that the average potential liability for these patients grew by 185 percent and 153 percent, respectively, over that period.44 as out-of-network billing becomes more commonplace, insurers and consumers may end up overlooking fraudulent charges, thus emboldening future fraudsters. therefore, the npi allows bad actors to enter a zone in which access to private health insurers’ funds is under-policed. iii. section 162.408 national provider system a. nps regulations and agency interpretation the language used in hipaa and the resulting regulations defining the 40. allen, loopholes, supra note 2. 41. national provider identifier standard (npi), supra note 3 (emphasis added). 42. for a primer on the differences between in-network and out-of-network providers, see in-network vs. out-of-network providers, cigna, https://www.cigna.com/individuals-families/ understanding-insurance/in-network-vs-out-of-network [https://perma.cc/c4bc-vtyf] (last visited july 25, 2020). for a primer on how billing by out-of-network providers (“balance billing” or “surprise billing”) impacts costs and what can be done to limit or prevent it, see issue brief: balance billing, ama (2016), https://www.ama-assn.org/media/14691/download [https://perma. cc/ra8h-w4vq]. for an example of a state-level proposal to limit the impact of surprise billing on patients, see s.b. 3, 121st gen. assemb., 1st reg sess. (ind. 2020). for an example of how surprise billing became part of the health care policy discourse in the run-up to the 2020 presidential campaign, see dan merica & tami luhby, buttigieg outlines middle-of-the-road approach to health care in new plan, cnn (sept. 19, 2019), https://www.cnn.com/2019/09/19/ politics/pete-buttigieg-health-care-plan/index.html [https://perma.cc/e8fj-t4c6]. 43. allen, loopholes, supra note 2. 44. see generally eric c. sun et al., assessment of out-of-network billing for privately insured patients receiving care in in-network hospitals, 179 jama internal med. 1543 (2019). 424 indiana health law review [vol. 18:417 multifarious purposes of the nps, the system that assigns npis to providers, suggests an opening for the possibility of licensure verification for npi applicants. recall that hipaa requires that the hhs secretary “adopt standards providing for a standard unique health identifier for each individual, employer, health plan, and health care provider for use in the health care system.”45 a plainmeaning, commonsense reading of the language in the statute would indicate that the secretary must devise standards for a system that assigns one unique identifier to each provider that applies for the identifier. based on the regulations that hhs promulgated in order to carry out the duties that congress assigned through hipaa, that plain-meaning, commonsense reading appears to be the one that the agency adopted. hhs has declared that the nps is responsible for “assign[ing] a single, unique npi to a health care provider.”46 with the addition of “single,” it is evident from this language that hhs intended for the nps to assign only one—and only one—npi to each provider who uses the nps to apply. it should be the case, then, that one could track a single provider by their assigned npi because each npi is unique and that one could track a single npi by the provider to which it has been assigned because each provider should only be assigned one npi. it should work both ways. in fact, in the announcement of its final rule for the npi and nps, cms specifically emphasized that the identifier’s utility as a tracking tool was a consequence of—and arguably conditional upon—the assignment of just one unique identifier to each provider.47 however, like david williams, the aforementioned texan trainer and inveterate fraudster, demonstrated, it is not only possible for an individual to acquire more than one npi, but it also easy for an individual to acquire more than one npi, thereby frustrating the intended purpose of the nps. for a system that relies on the honesty of its applicants48 to be charged with the crucial task of giving only one identifier to each applicant is difficult to understand, especially since the system does not have to leave itself open to such manipulation. in fact, nps regulations appear to give hhs and cms the means to protect the nps from bad actors: the nps “shall . . . assign a single, unique npi to a health care provider, provided that . . . the [hhs] secretary has sufficient information to permit the assignment to be made.”49 furthermore, in its final rule establishing the npi and nps, cms stated that the nps “must collect information sufficient to uniquely identify a health care provider.”50 taken 45. health insurance portability and accountability act of 1996, pub. l. no. 104-191, § 1173(b)(1), 110 stat. 1936, 2025 (emphasis added). 46. 45 c.f.r. § 162.408(a) (2021) (emphasis added). 47. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3452 (jan. 23, 2004) (“utilization review and other payment safeguard activities will be facilitated, since health care providers would use only one identifier and could be easily tracked over time and across geographic areas”). 48. allen, scammers, supra note 5. 49. 45 c.f.r. § 162.408(a)(2) (2021) (emphasis added). 50. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. at 3452. 2021] teamwork makes the scheme work 425 together, this language suggests that cms has a mandate from its own rules and regulations to establish a more rigorous system for assigning npis than the one that currently exists. even a reading that is more charitable to the current administration’s preference for minimal government involvement in health care would allow cms plenty of cover to improve the nps application process. the nps serves as the primary tool for collecting information from health care providers and assigning npis. therefore, it is reasonable to consider the operation of the nps as representative of hhs’s interpretation of the regulations providing that the agency must collect sufficient information to uniquely identify a health care provider in order to assign a single, unique npi to that provider. the case of david williams illustrates the insufficiency of the agency’s approach and, in so doing, calls into question the agency’s interpretation of its own regulations. just as the judicial branch will generally defer to an administrative agency’s interpretation of the statute it administers,51 so too will it tend to defer to an agency’s interpretation of its own regulations. the united states supreme court adopted the latter doctrine of deference in 1945 when it ruled for an agency administrator who sought to enjoin a manufacturer from violating the agency’s regulations, deciding that “the ultimate criterion [for interpreting administrative regulations] is the administrative interpretation, which becomes of controlling weight unless it is plainly erroneous or inconsistent with the regulation.”52 the court reaffirmed this deference in 1997 in its decision favoring the secretary of labor’s interpretation of regulations promulgated under the fair labor standards act.53 more recently, the court tightened the range of circumstances in which agencies would receive such deference; delivering the opinion of the court, justice kagan wrote that “the possibility of deference can arise only if a regulation is genuinely ambiguous . . . even after a court has resorted to all the standard tools of interpretation.”54 here, a court should not defer to hhs’s interpretation of the aforementioned regulations. first, the regulations are not genuinely ambiguous. the regulations require that the nps shall assign a single, unique npi to a provider; that the agency overseeing npi assignment must have sufficient information to permit the assignment; and that the assignment system must collect sufficient information to uniquely identify a provider. in other words, once the system has information that allows it to prove the identity55 of a provider and distinguish each provider from other providers,56 the system has what it needs to assign a single, unique npi to that provider. a plain-meaning reading of the regulations brings about an unambiguous result—or, at the very least, it allows observers to conclude with relative ease when those conditions have not been met in a particular scenario. 51. see generally chevron, u.s.a., inc. v. nrdc, inc., 467 u.s. 837 (1984). 52. bowles v. seminole rock & sand co., 325 u.s. 410, 414 (1945). 53. auer v. robbins, 519 u.s. 452, 461 (1997). 54. kisor v. wilkie, 139 s. ct. 2400, 2414 (2019). 55. see identify, black’s law dictionary (8th ed. 2004). 56. see unique, merriam-webster, https://www.merriam-webster.com/dictionary/unique [https://perma.cc/8yq3-v95v] (last visited july 25, 2020). 426 indiana health law review [vol. 18:417 second, even if the regulations were genuinely ambiguous, thereby triggering the possibility of deference, the hhs interpretation is inconsistent with the regulation because it does not meet the conditions required therein. therefore, hhs’s interpretation of these regulations does not merit deference. it is important, then, to devise an interpretation of the word “sufficient” that is suitable in this context. a condition that is sufficient for the occurrence of an event is a condition or set of conditions that will produce the event. sufficient conditions are different from necessary conditions, which must be present but do not bring about the occurrence of the event unless sufficient conditions are present.57 for example, it is sufficient that a number being divisible by four would make the number even, but it is not necessary. it is necessary that an animal be a mammal in order to be a human, but it is not sufficient. in the case of the nps application process, david williams, who acquired over twenty npis through the nps, showed that while the system collects information58 that is necessary for the assignment of a single npi to each provider, the system did not collect information that is sufficient for that assignment. what, then, does sufficiency mean in the instant context? since the matter has not been litigated or otherwise adjudicated, looking to another, more developed, and more contentious context for guidance may prove useful. b. interpreting “sufficiency” through the lens of civil pleading the realm of pleading in civil actions has seen a substantial evolution over the last two centuries, and this evolution can illustrate and make sense of the meaning of sufficiency. when bringing a civil action, a plaintiff files a complaint that alleges the facts that entitle the plaintiff to relief, and the defendant can then respond with a variety of answers. in the early days of american common law, what typically followed was a “complex dance” of responses between the parties.59 by the first half of the nineteenth century, this process, known as common-law pleading, tended to get messy due to the high volume of pleadings that each side filed.60 there was, indeed, a method to the madness: all that pleading had the effect of narrowing the scope of the case so that the issue at hand was relatively simple to understand and would allow the resulting trial to be a straightforward affair.61 it is not difficult to imagine, however, that this system 57. see dept. of philosophy, confusion of necessary with a sufficient condition, tex. st. u., https://www.txstate.edu/philosophy/resources/fallacy-definitions/confusion-of-necessary.html [https://perma.cc/uh2k-rn6g] (last visited july 25, 2020) (illustrating the ease with which one can confuse necessary and sufficient conditions). 58. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3457-60 (jan. 23, 2004). 59. ray w. campbell, getting a clue: two stage complaint pleading as a solution to the conley-iqbal dilemma, 114 penn st. l. rev. 1191, 1198 (2010). 60. see charles alan wright & mary kay kane, law of federal courts 471 (6th ed. 2002) (describing common-law pleading "wonderfully slow, expensive, and unworkable"). 61. charles e. clark, history, systems and functions of pleading, 11 va. l. rev. 517, 526 2021] teamwork makes the scheme work 427 made life difficult for newcomers to a given case, such as newly appointed judges or newly hired counsel, because they would then have to trace the dispute through a mountain of pleadings in order to determine what was at issue between the two parties. perhaps as a consequence of the process’s iterative nature, “sufficiency” was not as firm a barrier to the continuation of proceedings within this regime as it would eventually become; common-law pleading nevertheless accomplished the goal of tightening the focus of the matter at hand and simplifying the trial. while the common-law pleading paradigm may have been an effective way to narrow and simplify the issues to be litigated during trial, an unending backand-forth between parties is not an nps application model that would appeal to cms or to the providers who use the system. it is possible that the paradigm was sufficient, but it does not fit the needs of modern health care providers or the government agencies that regulate the industry. throughout the development of the npi and nps, cms has stressed the importance of efficiency for users and for regulators.62 therefore, an incredibly thorough, iterative process, though likely sufficient for the overall purpose of collecting information essential to the application, would fail to satisfy other goals of the nps and renders it unfeasible. the pleading regime that followed—code pleading—had its own challenges. midway through the nineteenth century, new york lawmakers, recognizing the difficulties associated with the drawn-out dance that pleading had become, sought to encourage the opposing parties to offer the facts salient to the matter at the outset of the process. the requirement that they established, which was then adopted in similar forms by more than half the country during the next halfcentury,63 was that the initial pleading must include a “plain and concise statement of the facts constituting a cause of action without unnecessary repetition.”64 in theory, this appears to be an effective way to condense the pleading process into fewer exchanges between the parties as they hash out the relevant details, thereby instilling some modicum of discipline in the proceedings.65 in practice, however, code pleading had become rather similar to the expensive, lumbering ordeal it had hoped to replace, except that its difficulties lied not in the duration of the process but in the initiation of the action. because the statement of facts constituting the action had to be plain and concise, and the (1925). 62. see, e.g., health insurance reform: standards for electronic transactions, 63 fed. reg. 25272, 25293 (may 7, 1998); standards for privacy of individually identifiable health information, 65 fed. reg. 82462, 82541 (dec. 28, 2000); health insurance reform: modifications to electronic data transaction standards and code sets, 68 fed. reg. 8381, 8381 (feb. 20, 2003); hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. at 3434. 63. clark, supra note 61, at 534. 64. act to amend the code of procedure, ch. 479, § 142, 1851 n.y. laws 887. this version was broadly similar to the original code, which had been established three years earlier. for the original version, see act to simplify and abridge the practice, pleadings, and proceedings of the courts of the state, ch. 379, § 120(2), 1848 n.y. laws 521. 65. campbell, supra note 59, at 1201. 428 indiana health law review [vol. 18:417 distinctions between facts, evidence, and conclusions of law were often difficult to parse,66 there was an inexorable tension between producing a technically proper pleading of one’s case67 and carving out enough room in the pleading for oneself to maneuver over the course of the action, leading to the dismissal of many otherwise meritorious claims.68 a sufficient statement of facts delivered at the outset of pleading was essential to the survival and success of a claim under this pleading regime, and it presented would-be plaintiffs with a high, albeit illdefined, bar to clear. placing such a substantial burden on providers at the outset of the nps application does not comport with cms’s goals for the system. the agency has stressed in a number of instances that it wants the acquisition of an identifier to be easy for providers69 and that generally seems to be the case.70 as such, incorporating stumbling blocks into the application process, such as the submission of difficult-to-obtain documentation or the assessment of a fee, clash with both the intentions of the agency and the demands of the users. the next innovation in pleading laid the foundation for the modern standard. nearly a century after new york adopted code pleading, the federal rules of civil procedure (“frcp”) came into effect and established a new pleading paradigm: notice pleading.71 rule 8 of the frcp requires that the complaint 66. see, e.g., edson r. sunderland, some difficulties of code pleading, 8 mich. l. rev. 400, 400-01 (1910); charles e. clark, the complaint in code pleading, 35 yale l.j. 259, 259-60 (1926). 67. see united states v. uni oil, inc., 710 f.2d 1078, 1080-81 n.1 (5th cir. 1983) (disparaging code pleading as a “hyper-technical reading of legal papers”). 68. david m. roberts, fact pleading, notice pleading, and standing, 65 cornell l. rev. 390, 395-96 (1980). 69. see, e.g., national standard health care provider identifier, 63 fed. reg. 25320, 25329 (may 7, 1998) (“in order to be integrated into electronic transactions efficiently, standard provider identifiers must be easily accessible.”); hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3468 (jan. 23, 2004) (“we will attempt to make the processes of obtaining npis and updating nps data as easy as possible for health care providers . . . .”). 70. compare national provider identifier (npi) numbers, am. speech-language-hearing ass’n, https://www.asha.org/practice/reimbursement/hipaa/npi/ [https://perma.cc/kdm9-lgyt] (last visited july 25, 2020) (“it takes less than [five] minutes to apply online and the number is issued within a few minutes.”), with npi frequently asked questions, indep. blue cross, https://www.ibx.com/providers/claims_and_billing/npi/faq.html [https://perma.cc/a9lx-bjs7] (last visited jan. 30, 2020) (“cms estimates that, in general, a health care provider who submits a properly completed, electronic application could have an npi within ten days.”), and u/rdrop, how long did it take to get your npi number from time of application?, reddit (apr. 11, 2016), https://www.reddit.com/r/medicalschool/comments/4ebu7z/how_long_did_it_take_to_ get_your_npi_number_from/ [https://perma.cc/7hlj-sp4c] (comparing applicant wait times for an npi, ranging from a few minutes to fifteen days). 71. see roberts, supra note 68, at 391 n.6 (“the term ‘notice pleading’ has achieved wide currency as a convenient shorthand description of the federal approach to pleading . . . . nowhere, 2021] teamwork makes the scheme work 429 contain “a short and plain statement of the claim showing that the pleader is entitled to relief” that is sufficient to put the opposing party on notice,72 and the defense may counter, under the authority of rule 12(b)(6), that the plaintiff has failed to state a claim for which relief can be granted.73 for the complaint to survive a rule 12(b)(6) motion to dismiss, then, it must state its claim sufficiently; only then can the action move forward. the supreme court took its first look at this new paradigm twenty years after the rule’s establishment.74 in conley v. gibson, the supreme court adopted a position on rule 8 that was relatively friendly to plaintiffs. forty-five black railroad workers, after being fired from their jobs and replaced by white railroad workers, filed suit against their union for failing to protect them to the same degree that the union had protected white union members.75 the defendants’ answer challenged the complaint on several grounds, the last of which was that the plaintiffs had failed to state a claim for which relief could be granted.76 the court sided with the plaintiffs, holding that the test for a complaint’s sufficiency was whether “it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.”77 because it was possible that evidence would support the allegations in the complaint, namely that the union to which the plaintiffs had belonged did not treat them in the same manner that it treated its white members, then the complaint was sufficient. under this standard—that is, the complaint is sufficient if the allegations therein are possible—getting past the initial hurdle of the complaint and moving into the discovery phase was much easier than it had been previously because the court set a relatively low bar for the definition of “sufficiency” for the complaints. this understanding of sufficiency as possibility appears to be the standard under which cms and its nps are currently operating. according to hhs regulations, cms must collect sufficient information to ensure that it assigns a single, unique npi to an individual. but cms also issues npis to applicants without verifying the information that they submitted regarding their identity and their credentials, relying instead on the applicants’ honesty78 and making only limited inquiries about the information submitted.79 if cms understands itself to be compliant with these regulations, then the agency seems to be taking the position that the possibility that the nps will assign a single, unique npi to an individual is sufficient to justify the npi’s assignment. this, of course, is not to say that the nps is not capable of accomplishing its objective. there is no however, do the federal rules use that term . . . .”). 72. fed. r. civ. p. 8(a)(2). 73. fed. r. civ. p. 12(b)(6). 74. see conley v. gibson, 355 u.s. 41 (1957). 75. id. at 42-43. 76. id. at 43-44. 77. id. at 45-46. 78. allen, scammers, supra note 5. 79. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3434 (jan. 23, 2004). 430 indiana health law review [vol. 18:417 evidence to suggest that the assignment of multiple npis to an individual—as a result of fraudulent activity or otherwise—is a widespread phenomenon. it is true, however, that the nps in its current form does not collect sufficient information to ensure that it assigns a single, unique npi to an individual. the next evolution in pleading raised the bar for sufficiency to its current level. in 2007, the supreme court abandoned the position it had taken in conley and instead embraced a new standard when it issued its decision in bell atlantic corporation v. twombly.80 in twombly, the plaintiffs, who were subscribers to local telephone and internet services, brought an action against local exchange carriers, alleging that the carriers engaged in parallel conduct to preclude competition in violation of the sherman act.81 the trial court granted the defendants’ rule 12(b)(6) motion to dismiss, which was then reversed on appeal to the circuit court. the supreme court reversed the circuit court’s decision and sided with the defendants, holding that, in the context of antitrust law, “a claim requires a complaint with enough factual matter” to plausibly infer that the plaintiff is entitled to relief.82 if the plaintiff could not point to facts that showed that the defendants had indeed agreed to engage in illegal activity, then simply alleging that a conspiracy existed due to the existence of parallel conduct is an insufficient statement of the claim. this ruling makes sense in the context of antitrust law because the court was concerned that the ease of pleading under the conley possibility standard would result in meritless cases ending in settlements for the plaintiffs.83 however, this new pleading standard did not remain exclusive to antitrust cases for long. when the court issued its decision in ashcroft v. iqbal, it upheld the twombly plausibility standard and expanded it to apply in all civil cases. the plaintiff, a muslim-pakistani citizen, was arrested in the wake of terrorist attacks on september 11, 2001 and allegedly deprived of constitutional protections while in custody; he filed suit against a number of federal officials, claiming that his treatment had been the result of discriminatory policies that these officials enacted.84 both the district court and the circuit court found that the plaintiff’s complaint was sufficient, but the supreme court reversed, holding that the plaintiff failed to plead sufficient facts to state his claim against the defendants.85 unable to allege facts indicating illegal and unconstitutional behavior on behalf of the defendants themselves, the plaintiff could allege only that his treatment was unconstitutional and that the defendants oversaw the agencies that carried out the treatment, and the court found that such a nonspecific complaint would place an unfair and overwhelming burden on the defendants during the discovery process.86 aside from its various policy implications across different areas of 80. see bell atl. corp. v. twombly, 550 u.s. 544 (2007). 81. id. at 549-51. 82. id. at 556. 83. id. at 559-62. 84. ashcroft v. iqbal, 556 u.s. 662, 666 (2009). 85. id. at 687. 86. see id. at 685-86. 2021] teamwork makes the scheme work 431 law,87 the court’s ruling in iqbal solidified and expanded the sufficiency-asplausibility standard to cover all civil cases and ushered in a brave new world for would-be plaintiffs. this new, more rigorous standard for sufficiency in pleading should serve as a model for the sufficiency to which cms should aspire in the design of its nps application process and the information that it collects. rather than continue operating with the apparent understanding of sufficiency as possibility, cms should instead adopt a view of sufficiency as plausibility. this standard would require that cms collect sufficient information to ensure that it is plausible—not just possible—that it has assigned a single, unique npi to an individual. one of the key differences between the contexts of pleading and the nps application, though, is that, unlike in pleading, where a higher sufficiency standard means a higher bar that plaintiffs must clear in order to survive, cms can obtain the information that it requires in order to meet this heightened standard without shifting the burden of producing information of higher quality or greater quantity to applicants when they apply for an npi. the regulation calling for sufficient information states only that the agency must collect it and does not specify the means or methods of that collection.88 the upshot is that cms can collect that information and still accomplish its goals of efficiency and ease for applicants while collecting sufficient information for the assignment of a single, unique npi to a health care provider. the nps can take steps to ensure that individuals—rather than only applicants and those already assigned an npi—receive a single, unique npi. the nps must assign a single, unique npi to an individual,89 and if the nps fails this task, the npi’s utility for billing and tracking purposes is severely diminished. that individual may be a physician, a subpart of a larger health care entity, a hospital system, or a myriad of other classifications of health care providers,90 but each of those distinct providers should only have a single, unique npi. currently, when the nps receives an application, it checks its database to determine whether the provider already has an npi.91 this step is important but does not protect the system from individuals like david williams, who attempt to present themselves as multiple providers through the use of falsified credentials. williams was able to acquire multiple npis by feeding the nps enough information to convince the 87. see, e.g., john m. landry, fact pleading after ashcroft v. iqbal: the implications for section 1 cartel cases, antitrust source 1 (oct. 2009), https://www.sheppardmullin.com/media/ article/796_fact%20pleading%20after%20ashcroft%20v%20iqbal.pdf [https://perma.cc/4jzzarzf]; alexander a. reinert, the costs of heightened pleading, 86 ind. l.j. 119, 130 n. 53 (2010). 88. 45 c.f.r. § 162.408(a)(2) (2021). 89. 45 c.f.r. § 162.408 (2021). 90. see 42 u.s.c. § 1395x (2021); 45 c.f.r. § 162.408(g) (2021); hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. 3434, 3437 (jan. 23, 2004). 91. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. at 3446. 432 indiana health law review [vol. 18:417 system that he was a new applicant and therefore did not already have an npi, and the system did not use or seek out information other than what it had received. he used the system’s passive collection of information against it. this weakness is emblematic of the insufficiency of the nps’s information collection procedures, such as they are. because the system passively collects information, it cannot assign npis with a level of certainty higher than the mere possibility that an individual will not receive more than one unique npi. luckily for cms, that collection does not necessarily have to be passive; the nps can seek out additional information to ensure that it does not assign more than one unique npi to an individual. verification of licensure or other credentials would be an appropriate and effective means of actively collecting sufficient information to assign a single, unique npi to an individual. possessing a state-issued professional license is a kind of shorthand for a high degree of institutional confidence in the license holder’s ability to carry out the duties of their profession. for example, in order to obtain a license to practice medicine in a particular state, one must earn certain degrees, pass certain exams, supply the state with a wealth of personal information, allow the state to conduct its own investigation of that information, and pay a fee, among other requirements.92 states do not make it easy to acquire such licenses—nor should they. states have an interest in protecting their citizens from unqualified or malicious practitioners, and licensure is an effective means of limiting consumer access to those practitioners. because states go to such lengths to ensure that the right professionals obtain licenses, it is likely that their databases of licensed professionals do not include serious discrepancies that would impede data collection and verification, making it an effective and efficient tool to ensure that the nps assigns only a single, unique npi to an individual. had the nps used license verification when david williams was attempting to get his insurance scheme off the ground, then it is unlikely that he would have been able to obtain one npi, let alone the nearly two dozen that he collected before his capture. on his applications, williams used his real name, address, and contact information, but he supplied false license information and lied about his status as a medical doctor.93 the nps would have scanned the texas database for medical licenses and found that the number williams had submitted did not match any existing records in the database. this would have trigged an inquiry to ensure that a clerical error did not occur in williams’s submission, and this inquiry is likely to have ended either with williams abandoning this avenue in favor of one with less oversight or with cms ultimately not issuing an npi because williams had no reason to possess one. even if williams had tried to be 92. see, e.g., ind. prof’l licensing agency, license information for physician/osteopathic physician applicants: minimum requirements to apply for a license, st. ind., https://www.in.gov/ pla/files/license%20checklist%20for%20physicians.pdf [https://perma.cc/8xtz-2tkv] (last visited july 25, 2020); med. bd. of cal., physicians and surgeons, st. cal., https://www.mbc. ca.gov/applicants/physicians_and_surgeons/ [https://perma.cc/5m2l-g9t3] (last visited july 25, 2020). 93. allen, scammers, supra note 5. 2021] teamwork makes the scheme work 433 clever by using the information of a real physician with a genuine medical license, it is likely that the real physician would have already acquired an npi, so the nps would have noticed the duplication during its normal internal verification and not assigned williams the npi without further investigation. presented with this suggestion, cms would likely raise two concerns. first, cms has stated that the assignment of npis is separate from, and would not eliminate, the existing processes that insurers use to verify the information that providers submit upon enrollment into their programs94 and that the nps is not meant to duplicate the efforts of other entities.95 second, the goal of the nps is to improve efficiency in health care, not to create additional barriers for providers. these concerns, though valid, are easily allayed. an automated license check to ensure that the nps assigns only a single, unique npi to an individual would be an infinitesimal step in comparison to the procedures that network enrollees must go through, and even if it is a duplication of effort, it would be a considerably small one at that. adding an automated license check would not require that applicants submit additional information, and it is unlikely that the check would drastically increase the amount of time that it takes the nps to assign an npi. the nps already carries out cursory investigations to resolve the discrepancies that it finds, so adding another one, especially one more effective at accomplishing the intended goal of the system, does not seem unreasonable. iv. a proposed solution because npis are so integral to the business of modern health care and because license verification is much easier today than it was in 2004, the npi application process should be used to screen bad actors in order to prevent them from billing insurers or causing other mayhem. from the inception of the nps and npi, cms theorized that the standardization that the nps created and maintained would enhance the agency’s ability to eliminate—or at least limit—fraud and abuse in health care programs by facilitating the tracking of providers and their activity, preventing duplication of identifiers and unauthorized access to data, and allowing government investigators and private entities to efficiently share provider information.96 those behind the passage of hipaa were eminently aware of the threat posed by fraudulent activity and included a provision for the establishment of a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers, or practitioners, as well as maintaining a database of final adverse actions taken against health care 94. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. at 3446. 95. id. at 3468. 96. national standard health care provider identifier, 63 fed. reg. 25320, 25347 (may 7, 1998). 434 indiana health law review [vol. 18:417 providers, suppliers, and practitioners.97 cms, agreeing with many commenters, maintained that verifying the information submitted by npi applicants would be too costly, as well as duplicative of the procedures that health plans use when they are deciding who to accept into their networks.98 recall that even though cms and many private insurers verify a provider’s credentials before granting admission to their networks, out-of-network providers can still tap into those private insurance dollars since insurers will pay them for submitted claims without verifying the credentials of the provider billing them.99 all states now have easily navigable, rapid-return license record databases for most professions, including physicians and others who might apply for npis;100 verifying whether npi applicants have the requisite licensure to provide the services they claim to provide would be quick, especially if the process was automated.101 therefore, because npis are so integral to the business of modern health care and because license verification is much easier today than it was in 2004, the npi application process should be used to screen bad actors in order to prevent them from billing insurers or causing other mayhem. v. the policy landscape as it stands currently policy change does not occur in a vacuum. this process is subject to a myriad of influences, and there are many competing theories and frameworks that attempt to impose some modicum of logic and to explain the extent to which different factors shape the process.102 while the efficacy of these ideas is up for debate, one common thread is the importance of individuals working together within and between institutions: policy change tends to be the product of sustained cooperation among appropriately situated actors.103 administrative officials, legislators, and the judiciary all have a role to play in protecting npis 97. health insurance portability and accountability act of 1996, pub. l. no. 104-191, § 221, 110 stat. 1936, 2009; see also health care fraud and abuse data collection program: reporting of final adverse actions, 63 fed. reg. 58341 (oct. 30, 1998); health care fraud and abuse data collection program: reporting of final adverse actions, 64 fed. reg. 57740 (oct. 26, 1999); health care fraud and abuse data collection program: reporting of final adverse actions; correction, 62 fed. reg. 70506 (nov. 24, 2000). 98. hipaa administrative simplification: standard unique health identifier for health care providers, 69 fed. reg. at 3452. 99. allen, loopholes, supra note 2. 100. see, e.g., search for a license, st. ind., https://mylicense.in.gov/everification/ search.aspx [https://perma.cc/25zs-2z2g] (last visited july 25, 2020); license search, st. cal., https://search.dca.ca.gov/ [https://perma.cc/d66y-9r6h] (last visited july 25, 2020). 101. allen, scammers, supra note 5. 102. for a useful table that summarizes major policymaking frameworks and their theoretical limitations, see generally matt grossman, artists of the possible: governing networks and american policy change since 1945, at 18 (2014). 103. id. at 173-74. 2021] teamwork makes the scheme work 435 from misuse; however, because not all of these actors have engaged directly with the matter, what follows is an examination of their recent actions related to health care fraud and how these actions may provide hints about the actors’ openness to a change in policy. a. cms despite administrator verma’s intense commitment to reducing the role of government in health care,104 cms has shown a recent willingness to be proactive in its fight against bad actors, though only to protect the integrity of its own programs. cms promulgated a new rule in september 2019 with the intent to ensure the removal and exclusion of entities and individuals who may threaten the integrity of medicare, medicaid, and the children’s health insurance program (“chip”) (collectively “cms programs”).105 the rule, which became effective on november 4, 2019, implemented a provision of the social security act that requires cms program providers and suppliers to disclose any current or previous direct or indirect affiliation106 with a provider or supplier that has uncollected debt; has been or is subject to a payment suspension under a federal health care program; has been or is excluded by the office of inspector general from medicare, medicaid, or chip; or has had its medicare, medicaid, or chip billing privileges denied or revoked (collectively “disclosable events”).107 once a provider has disclosed those affiliations, the hhs secretary is then permitted to deny enrollment in cms programs based on such an affiliation when the secretary determines that it poses an undue risk of fraud, waste, or abuse;108 cms also has the authority to deny or revoke enrollment across a wide range of circumstances, prohibit subsequent application attempts after an enrollment application has been submitted with false information, impose longer bars to reenrollment after having enrollment revoked, and more.109 when those providers make their disclosures about affiliations with certain entities, they are required to provide a wealth of information about the affiliation, including “general identifying data about the affiliated provider or supplier,”110 104. see seema verma, admin., ctrs. for medicare & medicaid servs., keynote remarks at the better medicare alliance 2019 medicare advantage summit (july 22, 2019), https://www.cms. gov/newsroom/press-releases/keynote-remarks-administrator-seema-verma-better-medicarealliance-bma-2019-medicare-advantage [https://perma.cc/5jq7-av3e]. 105. see medicare, medicaid, and children’s health insurance programs; program integrity enhancements to the provider enrollment process, 84 fed. reg. 47794 (sept. 10, 2019). 106. id. at 47798. 107. id. at 47794-95. 108. id. at 47794. 109. id. at 47794-95. 110. id. at 47810. this information includes the legal name reported to the internal revenue service or the social security administration, “doing business as” name, tax identification number, and npi. id. 436 indiana health law review [vol. 18:417 the “reason for disclosing the affiliated provider or supplier,” and “specific data regarding the relationship between the affiliated provider or supplier and the disclosing party,” as well as other information.111 before this new rule, cms lacked a regulatory basis to prevent such individuals or entities from continuing their fraudulent or abusive practices through other entities—absent factors such as the owning or managing of an individual’s or organization’s felony conviction, exclusion from medicare by the office of inspector general, or debarment from participating in similar federal programs.112 therefore, cms has shown a recent willingness to be proactive in its fight against bad actors and is using npis to aid in that fight, but only explicitly to protect the integrity of its own programs, though a compelling argument could be made that exclusion from participating in government health insurance programs would be such a stain on a provider’s reputation that private insurers would be unlikely to engage in official business relationships with that provider as well. b. the judiciary at least one federal court has exhibited a greater willingness to facilitate the investigation and elimination of health insurance fraud—albeit only with regard to government insurance programs. the third circuit court of appeals, in a decision issued in september 2019,113 held that qui tam relators offered enough facts to plausibly allege that a compensation agreement between the university of pittsburgh medical center (“upmc”) and neurosurgeons employed by its subsidiaries was in violation of the stark act.114 the compensation arrangement, wherein the neurosurgeons were rewarded as they completed more procedures which then necessitated referrals for ancillary hospital services (nursing, overhead, etc.), is not an uncommon arrangement across the country, which means that, if other courts take similar positions in the future, other hospitals and hospital systems might find themselves running into lengthy legal proceedings.115 even so, the third circuit’s willingness to ensure that critical government insurance dollars are not lost to fraudulent or abusive practices by ordering that 111. id. 112. id. at 47797. 113. united states ex rel. bookwalter v. upmc, 938 f.3d 397, 397 (3d cir. 2019). for the statute restricting physician referrals, see 42 u.s.c. § 1395nn (2021). 114. the stark act, passed in 1989 and named for then-congressman pete stark, is the federal prohibition on physician self-referral for health services covered by government insurance programs. originally, the stark act had a narrow focus on clinical laboratory services covered by medicare, but upon its expansion in 1993, the law’s scope grew to include a multitude of services covered by both medicare and medicaid. david e. matyas et al., legal issues is healthcare fraud and abuse: navigating the uncertainties 131 (4th ed. 2012); see omnibus reconciliation act of 1989, pub. l. no. 101-239, 103 stat. 2106; see also omnibus reconciliation act of 1993, pub. l. no. 103-66, 107 stat. 312. 115. bookwalter, 938 f.3d at 423 (ambro, j., concurring). 2021] teamwork makes the scheme work 437 the details of the situation are brought before the revealing light of discovery116 is heartening—even if the decision was an isolated occurrence and unlikely to bring about substantive change in the health care industry. c. the department of justice that the action exists at all seems to be in contravention of a prevailing trend within the department of justice. in january 2018, michael granston, director of the justice department’s fraud section, penned an internal memo117 outlining factors118 to be considered in the determination of qui tam119 action120 dismissals, citing a provision of the false claims act,121 which provides that the government “may dismiss” a false claims act case over the objections of the whistleblower who filed the suit, even for cases in which the justice department decides not to intervene—that is, as long as the court finds that the justice department’s rationale for dismissal meets one of two standards: one that generally favors the justice department122 or one that generally favors the relator.123 116. id. at 409-10, 417. 117. memorandum from michael d. granston, dir., fraud section, com. litig. branch, dept. of just., to fraud section att’ys & assistant u.s. att’ys handling false claims act cases (jan. 10, 2018), https://www.fcadefenselawblog.com/wp-content/uploads/sites/561/2018/01/memo-forevaluating-dismissal-pursuant-to-31-u-s.pdf [https://perma.cc/yb83-lctc]. 118. id. the “non-exhaustive” list of factors that the justice department may consider as basis for a dismissal: (1) curbing meritless actions, (2) preventing parasitic or opportunistic actions, (3) preventing interference with agency policies and programs, (4) controlling litigation brought on behalf of the federal government, (5) safeguarding classified information and national security interests, (6) preserving government resources, and (7) addressing egregious procedural errors. 119. “qui tam” is an abbreviation of the latin phrase “qui tam pro domino rege quam pro se ipso,” which means, “who sues on behalf of the king as well as for himself.” e.g., matyas et al., supra note 114, at 240. 120. the false claims act allows for an individual to come forward and provide to the government information about potential fraud. this individual, known as a qui tam relator, must serve both the local u.s. attorney and the u.s. attorney general with a copy of the complaint and written disclosure of the material evidence and information that the relator possesses. this complaint is then sealed for sixty days while the justice department investigates the allegations therein. the justice department can then decide to intervene and take over the litigation, to decline and allow the relator to proceed independently, or to seek dismissal of the action entirely. if the action is successful, including resolution through settlement, relators are given a portion of the recovery – up to thirty percent. veronica m. lei, ass’t gen. couns., eli lilly & co., & sara l. shudofsky, partner, arnold & porter kaye scholer llp, strange bedfellows: when doj moves to dismiss relator qui tams against pharma (oct. 8, 2019) (notes on file with author). 121. 31 u.s.c § 3730(c)(2)(a) (2021). 122. swift v. united states, 318 f.3d 250, 252 (d.c. cir. 2003) (“reading [31 u.s.c.] § 3730(c)(2)(a) to give the government an unfettered right to dismiss an action is . . . consistent with the federal rules of civil procedure.”). 123. sequoia orange co. v. baird-neece packing co., 151 f.3d 1139, 1145 (9th cir. 1998) 438 indiana health law review [vol. 18:417 the granston memo suggested that the justice department, newly equipped with enumerated and clarified bases for dismissal, would move to dismiss more qui tam relator actions in the future and be more successful when it does seek dismissal—and it has.124 since granston released the memo, the justice department has sought the dismissal of several actions for the reasons cited in the memo,125 and the justice department has had a success rate of nearly ninety-five percent when seeking dismissal.126 perhaps, though, the most emblematic application of the principles set forth in the memo has been the justice department’s efforts to dismiss a bevy of actions brought by the national healthcare analysis group127 (“nhag”), a datadriven, wall street-financed fraud detection firm. in june 2017, nhag, through one of its shell companies, health choice alliance (“hca”), filed eleven qui tam complaints in seven jurisdictions against dozens of defendants for essentially identical claims of self-enrichment at the federal government’s expense.128 after (“the qui tam statute itself does not create a particular standard for dismissal . . . . ‘a two-step analysis applies here to test the justification for dismissal: (1) identification of a valid government purpose; and (2) a rational relation between dismissal and accomplishment of the purpose.’”); see, e.g., lei & shudofsky, supra note 120. 124. for a discussion of how the approach outlined by the granston memo is a significant departure from prior justice department practices, see steven l. schooner, false claims act: greater doj scrutiny of frivolous qui tam actions?, 32 nash & cibinic rep. 59, 59-60 (2018). for a discussion of the granston memo’s near-immediate impact on actions from certain industries, see doj’s granston memo and recent government-requested dismissal of false claims act case have significant implications for fda-regulated entities, ropes & gray (nov. 26, 2019), https://www.ropesgray.com/en/newsroom/alerts/2019/11/dojs-granston-memo-and-recentgovernment-requested-dismissal-of-false-claims-act-case [https://perma.cc/5dfw-ak55]. 125. see motion to dismiss, united states ex rel. campie v. gilead scis., inc., no. c-11-0941 emc (n.d. cal. mar. 28, 2019), united states ex rel. cimznhca, llc. v. ubc inc., no. 17-cv765-smy-mab (s.d. ill. apr. 15, 2019), motion to dismiss, united states ex rel. polansky v. exec. health res., inc., no. 12-cv-4239-mmb (e.d. pa. aug. 20, 2019); universal health servs. inc. v. united states ex rel. escobar, 136 s. ct. 1986 (2016). 126. michael w. paddock & keeley a. mccarty, the granston memo in 2019: recent cases highlight the granston memo’s effectiveness as a tool to dismiss false claims act cases, nat’l l. rev. (dec. 5, 2019), https://www.natlawreview.com/article/granston-memo-2019-recent-caseshighlight-granston-memo-s-effectiveness-tool-to [https://perma.cc/dk9a-6vze]. 127. for a profile on the firm, its methods, and its founder, see j. c. herz, medicare scammers steal $60 billion a year. this man is hunting them, wired (mar. 7, 2016), https://www.wired. com/2016/03/john-mininno-medicare/ [https://perma.cc/4u4m-mgk4]. 128. john o’brien, plaintiffs lawyers in philly area representing clients that the doj says are wasting time filing meritless lawsuits, pa. rec. (jan. 8, 2019), https://pennrecord.com/ stories/511717647-plaintiffs-lawyers-in-philly-area-representing-clients-that-the-doj-says-arewasting-time-filing-meritless-lawsuits [https://perma.cc/ucj4-ezju]. for a complete list of the false claims act actions that nhag and its subsidiaries brought in 2017, see p. david yates, doj: a company created to file lawsuits has wasted 1,500 hours of the government's time, forbes (dec. 19, 2018), https://www.forbes.com/sites/legalnewsline/2018/12/19/doj-a-company2021] teamwork makes the scheme work 439 investigating the allegations, the justice department moved to dismiss all of the actions, arguing that the claims lacked the merit necessary to justify the cost of investigation.129 the u.s. district court for the eastern district of texas, for example, agreed with the justice department’s assessment and granted the motion to dismiss, finding that the government had met the more rigorous, relatively relator-friendly sequoia orange standard for dismissing the action.130 more than a year after the memo was released, granston did seem to temper the memo’s tenor and indicate that the justice department would not be scared off easily from pursuing worthy cases. granston warned attendees at the 2019 federal bar association’s false claims act conference that angling for “undue or excessive discovery will not constitute a successful strategy for getting the government to exercise its dismissal authority,”131 implying that the preservation of government resources lacks the primacy it was purported to have among the factors considered for dismissal. this ostensible change in tack, however, did not dissuade senator chuck grassley, the chairman of the senate finance committee, from penning a letter to attorney general william barr in september 2019 in order to relay his concerns about the department’s justifications for dismissing qui tam actions.132 a longtime advocate for qui tam relators, senator grassley opined that the trend started by the granston memo’s release would send a message that fraudulent activity would go unpunished as long as the litigation was sufficiently arduous and resource-intensive.133 senator grassley specifically questioned the role of the granston memo in the justice department’s decision created-to-file-lawsuits-has-wasted-1500-hours-of-the-governments-time/?sh=72d65307290b [https://perma.cc/yky7-lclw]. 129. for an analysis of the litigation resulting from hca’s claim against bayer and the precedent that the justice department’s treatment of nhag’s actions might set for future false claims act dismissals, see alison frankel, doj doubles down in brief to discredit ‘wall streetbacked’ false claims act whistleblower, reuters (feb. 25, 2019), https://www.reuters.com/ article/us-otc-fca/doj-doubles-down-in-brief-to-discredit-wall-street-backed-false-claims-actwhistleblower-iduskcn1qe2ix [https://perma.cc/7dhf-94t8]. 130. health choice all. llc v. eli lilly & co., 5:17-cv-00123-rws-cmc 7-8 (e.d. tex. 2019) (“dismissing health choice's claims is rationally related to that interest. if health choice's claims survived, the government would be required to expend resources. primarily, the government would need to make employees available for depositions . . . . the government would also need to expend resources monitoring health choice's claims. but, if the government dismisses health choice's claims, it will not have to expend those resources. that is a rational relationship: dismissal reduces governmental burdens.”) 131. michael a. rogoff & jennifer oh, michael granston cautions fca defense bar regarding the granston memo's "government burden" factor, arnold & porter (mar. 21, 2019), https://www.arnoldporter.com/en/perspectives/blogs/fca-qui-notes/posts/2019/03/granstoncautions-fca-defense-bar [https://perma.cc/ras4-y5vp]. 132. letter from chuck grassley, u.s. sen., iowa., to william barr, att’y gen., u.s. dep’t of just. (sept. 4, 2019), https://www.grassley.senate.gov/imo/media/doc/2019-09-04%20ceg% 20to%20doj%20(fca%20dismissals).pdf [https://perma.cc/vmp2-s7bc]. 133. id. 440 indiana health law review [vol. 18:417 to move for dismissal and asked attorney general barr for an explanation of the processes used to determine the extent of strain on government resources that such litigation would incur.134 it is currently unclear as to whether congress is considering any legislative move to impose a higher standard on the justice department when attempting to dismiss a qui tam relator’s action, though legislation compelling the dismissal of qui tam actions when the justice department decides against intervention may be on its way. even as the third circuit’s majority in the united states ex rel. bookwalter v. upmc apparently ran the risk of “opening the floodgates of litigation” by allowing the relators to proceed with their case, they noted that granston’s memo, which indicates the justice department’s “more aggressive approach to dismissing qui tam actions” by “urging its lawyers to consider dismissal every time the government decides not to intervene,” illustrates the extent to which the justice department—not the judiciary—is the true gatekeeper for qui tam actions.135 these actors, in addition to the senators who wrote to hhs secretary azar and cms administrator verma about npi misuse, seem to be at odds about the federal government’s role in policing the health care industry and preventing fraud, even when government resources are in jeopardy. this suggests that changes meant to limit fraud against private insurers would not be met with much enthusiasm under the current administration. vi. conclusion as the new millennium approached, bearing the promise of new opportunities and new complications, the federal government shouldered the responsibility of creating a system to streamline health care administration and developed the nps and npi. in doing so, it took up the mantle of gatekeeper for those who wished to bill health insurance plans. now that david williams has exposed a gap in the nps’s defenses, it is time for hhs and cms to tighten the system’s security in order to comply with its regulations, aided by the essential work that state licensing agencies have already done. the story, however, should not end there. agencies across the executive branch should reexamine systems of their own to determine whether enhanced data and technological capabilities open new avenues for accomplishing administration goals. 134. id. 135. united states ex rel. bookwalter v. upmc, 938 f.3d 397, 417 (3d cir. 2019). seize the moment: the opportunity to realize the human right to healthcare in the united states fran quigley* i was privileged to be eleanor kinney’s colleague. i was one of many who benefitted from her generous professional encouragement, and i learned much from both her word and her example. but one does not need to have known eleanor personally to recognize the theme of her life’s work. her decades of distinguished teaching, service, and advocacy all point in a direction best illustrated by the sheer number of her articles and presentations that revolved around a single phrase: the human right to healthcare. during eleanor’s career, her home country of the united states took significant steps in the direction of realizing that right, steps she helped push forward. the children’s health insurance program (chip) was created in 1997 and expanded in 2009. medicare’s part d prescription drug coverage passed in 2003. plus, the affordable care act was signed into law in 2010. all have had an enormous impact. but they have not been enough to fulfill eleanor’s vision of a fully realized right to health in the united states. even after the affordable care act’s implementation, 27 million u.s. residents are without insurance.1 tens of millions more are underinsured.2 even while many americans suffer from deficient or absent care, the united states continues to spend more per capita on healthcare than any other nation.3 yet, we may finally be on the cusp of change. “medicare for all” proposals enjoy an unprecedented level of momentum. well over half of americans support a public healthcare system that would cover all people and all costs.4 they also * clinical professor at the indiana university robert h. mckinney school of law, director of the health and human rights clinic. editor of the weekly publication, faith in healthcare, and coordinator of the non-profit advocacy group of the same name. author of four books and dozens of mass media and academic articles focusing on access to healthcare as a human right. portions of this essay have been published in different forms in the e-publication faith in healthcare. plug the hole, part 2: the problem with watered-down versions of medicare for all, faith in healthcare, https://faithinhealthcare.org/fhc/plug-hole-part-2-problem-watered-down-versionsmedicare-all [https://perma.cc/k45y-y3gs]. 1. key facts about the uninsured population, kaiser fam. found. (dec. 7, 2018), https://www.kff.org/uninsured/fact-sheet/key-facts-about-the-uninsured-population/ [https://perma.cc/m8kr-sd6v]. 2. natasha bach, more americans have health care coverage—but millions are underinsured, fortune (feb. 7, 2019), https://fortune.com/2019/02/07/americans-health-careunderinsured-rate/ [https://perma.cc/2zak-we7e]. 3. karen feldsher, what’s behind high u.s. health care costs, harv. gazette (mar. 13, 2018), https://news.harvard.edu/gazette/story/2018/03/u-s-pays-more-for-health-care-with-worsepopulation-health-outcomes/ [https://perma.cc/pyn2-gjba]. 4. morning consult & politico, national tracking poll #190675, june 29 – july 01 2019: crosstabulation results, morning consult 341 (2019), https://morningconsult.com/wpcontent/uploads/2019/07/190675_crosstabs_politico_rvs_v2_bh.pdf [https://perma.cc/np8x54 indiana health law review [vol. 17:53 support that public plan being a single-payer model, thus replacing private insurance companies, provided they can keep access to their preferred providers. that access is a hallmark of medicare for all legislation that is sponsored by more than 100 members of the u.s. house of representatives,5 more than a third of the democrats in the u.s. senate, and four leading candidates for the 2020 presidential election.6 let’s seize this opportunity to realize eleanor’s vision. and let’s not settle for any half-measures. i. fixing the hole in our healthcare pipeline despite a significant percentage of republican voters supporting a medicare for all program, nearly all of its legislative support comes from within the democratic party. most predictions are that, for the reform to happen, the democrats will first need to win control over the presidency and congress. but it may not be that simple. despite the populist demand for momentous change, there are proposals, even within the democratic party, that would retain the fundamental flaw of our current, broken system. senator joe biden and several other presidential candidates support a “public option,” a government health plan that would serve as one choice among existing for-profit private plans.7 house speaker nancy pelosi supports building on the affordable care act by offering more generous subsidies for purchasing insurance,8 again from private corporations. and the democrat-connected think tank center for american progress has advanced a proposal called medicare extra for all, promising automatic enrollment in health plans.9 the common thread running through all these proposals is that they retain a prime spot in our healthcare system for for-profit insurance corporations. so, what’s wrong with that? after all, the ultimate goal for healthcare reform—for eleanor kinney and for all of us who follow in her footsteps—is to ensure universal coverage, not to take down a particular industry. and passing 747y]. 5. medicare for all act of 2019, h.r. 1384, 116th cong. (2019). 6. kevin uhrmacher, kevin schaul & jeff stein, where 2020 democrats stand on healthcare for all, wash. post, https://www.washingtonpost.com/graphics/politics/policy2020/medicare-for-all/ [https://perma.cc/zm5r-fye9]. 7. christina zhao, 2020 candidate joe biden backs medicare public option: ‘you all should have a choice’, newsweek (apr. 29, 2019, 09:22 pm), https://www.newsweek.com/2020candidate-joe-biden-backs-medicare-all-policy-you-all-should-have-choice-1409332 [https://perma.cc/8rkt-pj4a]. 8. bruce japsen, pelosi wants more americans subsidized to buy obamacare, forbes (jan. 6, 2019, 9:20 am), https://www.forbes.com/sites/brucejapsen/2019/01/06/pelosi-wants-moreamericans-subsidized-to-buy-obamacare/#6d7d69491d27 [https://perma.cc/dfw3-glbu]. 9. medicare extra for all, ctr. for am. progress (feb. 22, 2018, 6:00 am), https://www.americanprogress.org/issues/healthcare/reports/2018/02/22/447095/medicare-extrafor-all/ [https://perma.cc/9nk3-5cl8]. 2020] seize the moment 55 any of these proposals into law would undoubtedly be an easier lift politically than medicare for all. the health insurance industry already spends tens of millions of dollars on lobbying, political campaign donations,10 and public relations. inevitably, the industry will ramp up those efforts to resist a singlepayer system that represents an existential threat to its business model. yet the proposals from biden, pelosi et al. that keep a role for private health insurance are not mere political compromises. they leave undisturbed the fundamental flaw in the u.s. system,11 the prime reason for the tragic irony of us paying more for worse outcomes than other countries: we waste approximately $500 billion each year in healthcare money spent not on care,12 but on private insurance corporations’ executive pay, shareholder returns, and a massive bureaucracy devoted to contesting insurance claims and marketing. the metaphor is an obvious one: other countries enjoy better, less expensive healthcare because they deposit their healthcare dollars into a pipeline that flows directly to patients. in the united states, we put a historically abundant supply of dollars into our pipeline at the front end. however, we have allowed a gaping hole to develop in the middle, diverting hundreds of billions in taxpayer dollars to the benefit of wealthy corporate shareholders and ceo’s making as much as $83 million per year.13 too few dollars are trickling through to the end of the pipeline, where sick people in need of care are located. if we are going to overhaul our system to finally provide healthcare for all, we need to plug that hole. in addition, most of the healthcare reform proposals that retain a role for private insurance corporations also preserve a profound injustice in our current broken system: the deductibles and copays that so often prevent insurance coverage from translating to actual healthcare. four in ten working americans have a high-deductible plan.14 this force them to pay thousands of dollars out of pocket before they get any benefit from the premiums taken from their paychecks 10. see ctr. for responsive pol., industry profile: insurance, opensecrets, https://www.opensecrets.org/federal-lobbying/industries/lobbyists?cycle=2019&id=f09 [https://perma.cc/5458-gfkd]; see generally ctr. for responsive pol., insurance: summary, opensecrets, https://www.opensecrets.org/industries/indus.php?ind=f09 [https://perma.cc/6k52lk5y]. 11. see generally feldsher, supra note 3. 12. emily gee & topher spiro, excess administrative costs burden the u.s. health care system, ctr. for am. progress (apr. 8, 2019, 1:00 pm), https://www.americanprogress. org/issues/healthcare/reports/2019/04/08/468302/excess-administrative-costs-burden-u-s-healthcare-system/ [https://perma.cc/cly4-nac2]. 13. evan sweeney & mike stankiewicz, health insurance ceos earned $342.6m in 2017, fiercehealthcare (may 7, 2018, 9:30 am), https://www.fiercehealthcare.com/payer/ceo-pay2017-342-million-unitedhealth-molina-cigna-aetna [https://perma.cc/f533-umwu] 14. see morgan haefner, payer issues: cdc finds 43.2% of americans have highdeductible health plans: 4 additional stats, becker’s healthcare (feb. 23, 2018), https://www.beckershospitalreview.com/payer-issues/cdc-finds-43-2-of-americans-have-highdeductible-health-plans-4-additional-stats.html [https://perma.cc/6lwk-tu4h]. 56 indiana health law review [vol. 17:53 each week. the average amount of those deductibles has increased by more than 300% in the past decade.15 that means that many who are insured are forced to go without care.16 they skip doctor visits, they don’t fill prescriptions,17 they cut their pills in half. this is true for many americans under the current medicare system too, with almost 40% of medicare enrollees reporting that they skip care each year because of cost.18 the medicare for all legislation proposals in the u.s. house and senate use the medicare name, but they would eliminate co-pays and deductibles. despite the evidence that patient cost-sharing is proven to reduce the care compliance of persons with chronic illnesses,19 the public option and aca expansion plans keep those barriers in place—setting those persons up for damaging and expensive health crises. ii. taxpayer healthcare dollars funding corporate profits, poor care given the central role that corporate money plays in our u.s. political system, it will come as no surprise that the most fervent supporters of preserving the role of for-profit health insurance corporations are financially tied to . . . for-profit health insurance corporations. virtually all of the democratic party supporters of the public option and aca expansion receive substantial funding from those corporations.20 while well-funded lawmakers and think tanks parrot the industry’s talking points, the industry often takes the messaging into its own hands.21 health 15. premiums for employer-sponsored family health coverage rise 5% to average $19,616; single premiums rise 3% to $6,896, kaiser fam. found. (oct. 3, 2019), https://www.kff.org/health-costs/press-release/employer-sponsored-family-coverage-premiumsrise-5-percent-in-2018/ [https://perma.cc/zb7t-urtw]. 16. aimee picche, higher health insurance deductibles a sickening trend for americans, cbs news (june 13, 2019, 3:34 pm), https://www.cbsnews.com/news/high-health-insurancedeductibles-a-sickening-trend-thats-causing-financial-hardship/?fbclid=iwar0dlneqs l1jccjdexzlwkx71jb86c7m31lucfwcjnnbncryi0kflt8qdt0 [https://perma.cc/ag45-2hvj]. 17. id. 18. darla mercado, why nearly 4 in 10 people on medicare skip their doctor’s visits, cnbc (sept. 26, 2018, 1:04 pm), https://www.cnbc.com/2018/09/26/why-nearly-4-in-10-peopleon-medicare-skip-their-doctors-visits.html [https://perma.cc/kf6w-c5y7]. 19. aaron e. carroll, people with chronic illness fare worse under cost-sharing, ny times (may 19, 2014), https://www.nytimes.com/2014/05/20/upshot/why-patients-with-chronicillnesses-should-pay-less.html [https://perma.cc/cwj4-vwc5]. 20. michael corcoran, meet the health care industry’s favorite democrats, truthout (oct. 31, 2018), https://truthout.org/articles/meet-the-health-care-industrys-favorite-democrats/ [https://perma.cc/lz32-947g]. 21. see jeff stein, ‘we’ve done a lot more than you would think’: how the healthinsurance industry is working to pull democrats away from medicare-for-all, wash. post (apr. 12, 2019), https://www.washingtonpost.com/business/2019/04/12/weve-done-lot-more-than-you2020] seize the moment 57 insurance ceos like cigna’s david cordani, who has made as much as $49 million in annual compensation,22 predictably oppose medicare for all. instead, cordani and his colleagues enthusiastically support an expansion of the “publicprivate partnerships,” arrangements that directly divert taxpayer healthcare dollars to their corporations.23 those partnerships are already substantial. for-profit health insurance corporations received a total of $307 billion in medicaid dollars in 2018—a little more than half of all state and federal government spending in the program.24 the affordable care act’s incentives for states to expand medicaid has caused the number of such arrangements to double in recent years.25 the basic “managed care” arrangement is that private corporations are paid a set fee from government dollars each month for every medicaid patient enrolled in their plan.26 the inherent problem is the incentive for corporations to increase their profits by limiting the amount they spend on care. savings are achieved by restricting patients to a closed network of providers and by denying claims for care reimbursement. dr. andrew bindman, former director of the federal agency for healthcare research and now a professor at the university of california-san francisco, told kaiser health news in 2018 “[t]his system is ripe for profittaking, and there is virtually no penalty for performing badly.”27 in that same report, kaiser noted that, in california alone, insurance corporations made $5.4 billion in profits from 2014 to 2016.28 predictably, a substantial amount of data and reporting shows that some of these private profits came from cutting costs in ways that caused patient suffering.29 across multiple would-think-how-health-insurance-industry-is-working-pull-democrats-away-medicare-for-all/ [https://perma.cc/msx5-aypf]. 22. mara lee, cigna ceo received $49 million in compensation last year, hartford courant (mar. 21, 2016, 7:07 pm), https://www.courant.com/business/hc-cigna-ceo-pay20160321-story.html [https://perma.cc/r2wa-m346]. 23. paige minemyer, ahip19: cigna’s cordani says it’s time to press pause on ‘medicarefor-all’ talk—but change is necessary, fiercehealthcare (june 19, 2019, 5:49 pm), https://www.fiercehealthcare.com/payer/ahip19-cigna-s-cordani-says-it-s-time-to-press-pausemedicare-for-all-talk-but-change [https://perma.cc/6428-pgnc]. 24. bob herman, most medicaid dollars go to health insurers, axios (apr. 19, 2019), https://www.axios.com/medicaid-managed-care-spending-health-insurers-224b5068-bcfe-495aaef5-b90e9f1c4c10.html [https://perma.cc/6yk4-yey3]. 25. see christine vestal, managed care explained: why a medicaid innovation is spreading, pew trusts (may 31, 2011), https://www.pewtrusts.org/en/research-and-analysis/ blogs/stateline/2011/05/31/managed-care-explained-why-a-medicaid-innovation-is-spreading [https://perma.cc/d8ba-vhrs]. 26. id. 27. chad terhune, billions of tax dollars flow to private medicaid plans. but is anyone minding the store?, l.a. times (oct. 18, 2018, 2:25 pm), https://www.latimes.com/business/la-fimedicaid-private-insurance-20181018-story.html [https://perma.cc/m9rf-hfhg]. 28. id. 29. see id. 58 indiana health law review [vol. 17:53 states that have outsourced their medicaid duties to private corporations via the managed care model, lawmakers and patients complain about poorly managed and wrongfully denied care.30 for example, in texas, young d’ashon morris was left permanently braindamaged when his medicaid care was reduced to a dangerously low level.31 that fateful decision to reduce morris’s care saved money for the corporation that texas pays to manage medicaid, a common enough occurrence that it triggered an award-winning year-long investigation by the dallas morning news called “pain and profit.”32 similar privatizing arrangements have caused an outcry in states like iowa,33 where reduced care has led to lawsuits and complaints by both patients and providers. more broadly, recent research shows that medicaid members in private corporation plans have more difficulty managing their asthma and blood pressure compared to their counterparts in public programs.34 yet the congressional budget office has concluded that pushing medicaid care to private corporations has actually increased government spending.35 iii. the for-profit incentive to deny care the medicaid managed care story is mirrored by the tale of medicare advantage plans, another process that diverts billions of public healthcare dollars to private corporations. twenty million americans on medicare have chosen the private insurance option of advantage plans, a number that represents a full onethird of medicare enrollees.36 many experts predict that, within a few years, half of all americans on medicare will be enrolled in an advantage plan.37 30. id. 31. j. david mcswane, lawmakers want answers after dallas morning news exposes widespread failure of care, dallas morning news (june 19, 2018. 6:51 pm), https://www.dallasnews.com/news/2018/06/19/lawmakers-want-answers-after-dallas-morningnews-exposes-widespread-failure-of-care/ [https://perma.cc/g3t8-r9dk]. 32. id. 33. simon davis-cohen, iowa privatized medicaid: it has been a disaster. here’s why., tarbell (apr. 25, 2019), https://tarbell.org/2019/04/iowa-privatized-medicaid-it-has-been-ad isas te r -h e res -w h y/? re f= fea tu re d & l in k _ id = 2 & c a n _ id = 1 9 4 4 7 0 cb8 6 6 f4 3 4 b7 bee8db26aacc172&source=email-privatized-medicaid-is-failing-iowans-and-drug-distributors-feelthe-heat&email_referrer=email_535719&email_subject=privatized-medicaid-is-failing-iowansand-drug-distributors-feel-the-heat [https://perma.cc/8cm4-vptv]. 34. managed care’s effect on outcomes, medicaid and chip payment and access comm’n, https://www.macpac.gov/subtopic/managed-cares-effect-on-outcomes/ [https://perma.cc/ md7j-gweb]. 35. terhune, supra note 27. 36. robert pear, medicare advantage plans found to improperly deny many claims, n.y. times (oct. 13, 2018), https://www.nytimes.com/2018/10/13/us/politics/medicare-claims-privateplans.html [https://perma.cc/u6d8-q7e5]. 37. id. 2020] seize the moment 59 that enrollment is fueled by the aggressively advertised surface attractions of advantage plans. the private plans set a limit on out-of-pocket medical expenses, which traditional medicare does not. furthermore, some advantage plans offer added benefits like dental, vision, and drug coverage.38 but there is a catch: the corporations more than make up their costs of offering these benefits by cutting their expenses elsewhere. as with medicaid managed care plans, they restrict enrollees to a limited network of providers, which means that going outof-network for care can trigger a huge cost to patients.39 that outcome can be difficult to avoid, as a center for medicare and medicaid services analysis showed that nearly half of all advantage corporations’ listings of networkincluded physicians contained errors.40 the department of justice in 2017 fined two advantage plans $32 million for misrepresenting the scope of their networks, among other misleading practices.41 for-profit advantage corporations choose their network options with the goal of saving expenses and maximizing profit. and that can lead to compromised patient care. a brown university study showed that medicare advantage enrollees are more likely to enter a lower-quality nursing home than someone enrolled in traditional medicare.42 those findings were included in a kiplinger’s retirement report analysis showing that advantage plans can work well for seniors—as long as they don’t need too much care.43 judith stein, executive director of the center for medicare advocacy, told kiplinger “[b]ut if they become ill or injured and really need a significant length of care, they are not as well-served.”44 that conclusion is consistent with a recent, disturbing report by the inspector general of the u.s. department of health and human services.45 the inspector 38. u.s. centers for medicare & medicaid services, medicare advantage plans cover all medicare services, medicare, https://www.medicare.gov/what-medicare-covers/what-medicarehealth-plans-cover/medicare-advantage-plans-cover-all-medicare-services [https://perma.cc/6v66wu8p]. 39. gretchen jacobson, matthew rae, tricia neuman, kendal orgera & cristina boccuti, kaiser fam. found. (oct. 5, 2017), https://www.kff.org/medicare/report/medicare-advantagehow-robust-are-plans-physician-networks/ [https://perma.cc/jm85-lfyr]. 40. lisa ward, beware medicare advantage plans, wall street j. (nov. 27, 2016, 10:11 pm), https://www.wsj.com/articles/beware-medicare-advantage-plans-1480302660 [https://perma.cc/p9hj-9pa2]. 41. faegre baker daniels, an unsettling settlement: health plan to pay $32 million to settle coding and provider network misrepresentation charge, jd supra (june 6, 2017), https://www.jdsupra.com/legalnews/an-unsettling-settlement-health-plan-to-57981/ [https://perma.cc/9wkk-aqgx]. 42. eleanor laise, medicare vs. medicare advantage: ill health often leads to plan switch, kiplinger (apr. 11, 2018), https://www.kiplinger.com/article/retirement/t039-c000-s004medicare-vs-medicare-advantage-ill-health-switch.html [https://perma.cc/mn3n-zr79]. 43. id. 44. id. 45. medicare advantage appeal outcomes and audit findings raise concerns about service 60 indiana health law review [vol. 17:53 general found “widespread and persistent problems” with improper denials of care and payment by advantage programs.46 the report showed that three of every four appeals of advantage program denials of care and payment led to reversals at the very first stage of review, a remarkably high error rate.47 less remarkable was the inspector general’s conclusion about the root cause of so many wrongful denials of care and payment. as with medicaid managed care programs, medicare advantage corporations are paid a set fee per patient, thus creating the motive to deny expensive claims. the inspector general concluded,”[a] central concern about the (advantage program) is the potential incentive for insurers to inappropriately deny access to services and payment in an attempt to increase their profits.”48 the savings from wrongfully denied care may be fueling profits, but they are not reducing costs to the taxpayers that fund the programs. in fact, medicare advantage programs cost the government four percent more per person than traditional medicare.49 iv. why not a public option? most of us who have wrangled with our own health insurance companies are well aware of the problems inherent in a system that incentivizes the denial of care. health insurance corporations reliably score near the bottom of consumer satisfaction surveys.50 how can that dismal corporate image be reconciled with the claims of some democrats like speaker pelosi that “[a] lot of people love having their employer-based insurance”?51 it turns out that pelosi et al. are misreading the views of the american public. when polling questions drill down a bit, they reveal that people want to retain access to their preferred healthcare providers, not necessarily their insurance company.52 further, keeping access to providers is actually far more likely in a public medicare for all system, which features free choice of providers, than in and payment denials, off. of inspector gen. (sept. 25, 2018) https://oig.hhs.gov/oei/reports/oei09-16-00410.asp [https://perma.cc/6e3g-ag2h]. 46. id. 47. id. 48. id. 49. medicaid payment advisory comm’n, medicare payment policy: report to congress 367 (mar. 2017), http://medpac.gov/docs/default-source/reports/mar17_entirereport.pdf [https://perma.cc/cvr3-r2sm]. 50. axios, polls: americans aren’t happy with their health insurance are you?, countable (nov. 13, 2018), https://www.countable.us/articles/15093-polls-americans-aren-thappy-health-insurance [https://perma.cc/bb8m-qw9p]. 51. paul kane & rachael bade, ‘i’m agnostic’: pelosi questions whether medicare-for-all can deliver benefits of obamacare, wash. post (apr. 4, 2019, 8:21 pm), https://www. washingtonpost.com/politics/im-agnostic-pelosi-questions-whether-medicare-for-all-can-deliverbenefits-of-obamacare/2019/04/04/fe2942c0-56ed-11e9-aa83-504f086bf5d6_story.html [https://perma.cc/jwm5-dvny]. 52. morning consult & politico, supra note 4, at 357. 2020] seize the moment 61 a network-constrained system of employer-provided for-profit health insurance. in our current private insurance model, job turnover and employer-initiated plan switches mean that one of every four americans switch their health insurance plans each year,53 and risk being barred from their preferred doctor or hospital as a result. so why not embrace a public option plan? surely, the clear benefits of the public health plan—with no deductibles, no incentive to deny claims, and broader access to providers—can compete favorably with private insurance. as biden says, “[w]hether you’re covered through your employer or on your own or not, you all should have a choice to be able to buy into a public option plan for medicare . . . if the insurance company isn’t doing the right thing by you, you should have another choice.”54 that choice would be a no-brainer—if the competition was a fair one. but it won’t be. as is already the case with medicare vs. medicare advantage, forprofit corporations will push the sicker and more expensive enrollees to the public program—thus socializing the risk of insurance while privatizing the profits. plus, those corporations will inevitably deploy their legions of lobbyists and millions in campaign dollars to push for government regulations and policies that benefit the for-profit options and undermine the public program. these procorporate practices are already being embraced by the trump administration to benefit the advantage programs in their competition with traditional medicare.55 the unchecked corporate ability to game the u.s. regulatory system is a key difference between any u.s. public option or aca expansion proposal and the systems in other nations that retain a role for private insurance corporations. nations such as germany do accommodate private insurance, but only in a carefully circumscribed role and with substantial involvement by non-profit companies, an approach far removed from any of the current u.s. proposals.56 v. seize the opportunity for meaningful reform most fundamentally, keeping or even expanding the current practice of using taxpayer dollars to subsidize the profiteering of private corporations translates to a lost opportunity. proposals that bypass medicare for all to protect corporate ceo’s and shareholders deny the rest of us the benefit of massive savings—wellrepresented by the shocking disparity between medicare’s overhead administrative costs of around 2% and private corporations’ estimated overhead 53. matt bruenig, people lose their employer-sponsored insurance constantly, people’s pol’y project (apr. 4, 2019), https://www.peoplespolicyproject.org/2019/04/04/people-lose-theiremployer-sponsored-insurance-constantly/ [https://perma.cc/26yk-ea45]. 54. zhao, supra note 7. 55. robert pear, trump administration peppers inboxes with plugs for private medicare plans, n.y. times (dec. 1, 2018), https://www.nytimes.com/2018/12/01/us/politics/trumpmedicare-advantage-plans.html [https://perma.cc/mz5y-u56t]. 56. adam gaffney, single-payer or bust, dissent (spr. 2018), https://www.dissentmagazine. org/article/single-payer-or-bust-two-souls-universal-healthcare [https://perma.cc/rnf3-mdzs]. 62 indiana health law review [vol. 17:53 of 20%.57 as multiple economic analyses have demonstrated, the savings from plugging up the pipeline hole diverting healthcare dollars to for-profit waste can fund our expansion into the universal coverage.58 a final problem with preserving an option for for-profit insurance plans is that the universality of the medicare for all system is critical to its survival as a new institution in the united states. the well-settled political reality in the united states and beyond is that universal benefit programs survive and even thrive, while limited-eligibility programs are at perpetual risk of reduction or even elimination. social security, medicare, and public education have become the “third rail” of u.s. politics—elected officials touch them at their peril. compare that to means-tested programs like the supplemental nutrition assistance program (snap, aka food stamps), the temporary assistance for needy families program, and head start. all produce remarkable benefits yet have been on the budgetary chopping block for decades. medicare for all will avoid that fate, and derive its political strength, from its final two words—”for all.” democratic party leaders know all this. so, it’s time for them to overcome their fear of a powerful industry. it is time for them to listen to americans who are demanding a substantial and sustainable change. it is time for them to seize the moment, and finally fulfill eleanor kinney’s lifelong quest to see healthcare become a realized human right. 57. dean baker, a warning for the washington post’s fact checker on single payer costs, ctr. for econ. & pol’y res. (sept. 19, 2017), http://cepr.net/blogs/beat-the-press/a-warning-forthe-washington-post-s-fact-checker-on-single-payer-costs [https://perma.cc/pff7-vtd6]. 58. new study does the math: yes, we can afford medicare for all, faith in healthcare, https://faithinhealthcare.org/fhc/new-study-does-math-yes-we-can-afford%c2%a0medicare-all [https://perma.cc/tvz3-3dmr]. free speech and scientific exchange: testing the limits of fda’s authority to regulate manufacturer scientific discussions dr. seth b. whitelaw & darshan kulkarni, pharm.d., m.s., esq.* i. introduction ever since congress enacted the federal food, drug, and cosmetic act (“ffdca”) in 1938, dynamic uncertainty has existed regarding the rules and restrictions on speech1 made by pharmaceutical and medical device companies, their employees, and their agents, including healthcare professional consultants (collectively “manufacturers”). the u.s. food and drug administration (“fda”) has long asserted its right to restrict manufacturers’ speech promoting or discussing unapproved (i.e., off-label) uses of drugs or medical devices. however, with the introduction of field-based medical support (i.e., medical affairs), by the upjohn company in 1967, the focus began expanding beyond just promotional claims to encompass any scientific discussions or scientific exchange by manufacturers.2 the fda’s rules and restrictions surrounding manufacturer speech were clearly outlined through the late 1990s. however, rulings by the u.s. supreme court and other lower courts have posited new limits on fda’s authority to regulate the limits on speech by manufacturers. based on these rulings, the fda limited the rights to regulate or restrict manufacturer scientific speech. furthermore, any permissible restrictions by the fda are controlled by the first amendment and not the ffdca. the breadth of permitted first amendment restrictions turns on whether manufacturer scientific speech is commercial or non-commercial (so-called “pure speech”). however, without a definitive ruling by the supreme court on how to consider such speech, manufacturer scientific speech classifies as pure speech. therefore, the fda’s authority is limited to addressing false or misleading speech and imposing time limits, place, and manner restrictions that are subject to “strict * dr. whitelaw is senior fellow and adjunct professor, life science compliance at mitchell hamline school of law, president & ceo of whitelaw compliance group, llc, and the editor of policy & medicine compliance update. dr. kulkarni is the principal attorney at the kulkarni law firm where he provides legal, regulatory and compliance advice to fda regulated companies. kulkarni is an adjunct professor at the drexel university school of law, was previously chair of the aba life sciences interest group and served as director of compliance for phactmi, an industry consortium of medical information professionals. he also interviews people on his popular darshantalks podcast focused on legal, regulatory and compliance updates in the life sciences industry. the views expressed in this article are solely those of the authors and do not represent the views of any current or former employers. this article is not intended to provide legal advice or substitute for appropriate legal representation. 1. as used throughout this article, “speech” describes both oral and written materials. 2. see sandeep k. gupta & roopa p. nayak, an insight into the emerging role of regional medical advisor in the pharmaceutical industry, 4 perp. clinical rsch. 186, 187 (2013). 336 indiana health law review [vol. 20:335 scrutiny” by the courts. ii. fda’s traditional authority to regulate manufacturer speech fda asserts its authority to regulate the labeling, advertising, and promotion of drugs and medical devices by a complex connection of ffdca provisions,3 which predate the second world war. the act prohibits introducing a misbranded drug or device into interstate commerce.4 a drug or device is considered misbranded if the product’s labeling: (1) is false or misleading in any way; (2) it does not contain adequate directions for use; or (3) it does not contain clear and comprehensible warnings of potential consequences resulting from its use.5 thus, fda’s authority to control manufacturer speech under the misbranding provision is through the products’ labeling and its intended use. however, misbranding turns on whether the manufacturer’s statements are “false or misleading.” a plain reading of the statute suggests that if the statements are truthful and not misleading, the product is not, by definition, misbranded, rendering it free from fda enforcement. the ffdca defines labeling as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”6 however, the supreme court expanded and refined the definition by clarifying that “accompanying” does not necessitate physical attachment, but instead, “[i]t is the textual relationship that is significant.”7 the fda defines “intended use” as “the objective intent of the persons legally responsible for the labeling of drugs.”8 to determine a product’s intended use, “the agency may look to any relevant source of evidence,” including product advertising, which the act does not explicitly define.9 however, if the advertising is either false or misleading, the fda can use that to support a misbranding charge.10 thus, “[t]he manufacturer’s intent will necessarily be determined on a case-by-case basis, looking at the totality of the facts and circumstances.”11 the combination of misbranding, labeling, and intended use allows the fda to assert broad regulatory authority over product-related speech. therefore, until 3. federal food, drug, and cosmetic act, pub. l. no. 75-717, 52 stat. 1040 (1938). 4. 21 u.s.c. § 331(a) (misbranding applies to any fda regulated product including food, drugs, devices, or biologics). under the federal trade commission act, the ftc regulates unfair or deceptive acts and practices affecting interstate commerce, which includes the express authority to address false advertising made by a company. see 15 u.s.c. §§ 44, 45(a)(1), 52(a). 5. see 21 u.s.c. §§ 321(n), 352(a)(1), 352(f). 6. 21 u.s.c. § 321(m). 7. kordel v. united states, 335 u.s. 345, 350 (1948). 8. see 21 c.f.r. §§ 201.128, 801.4 (2021). 9. 21 c.f.r. §§ 201, 801 (as amended by 86 fed. reg. 41383, 41388 (2021) (regulations regarding “intended uses”)). 10. id. 11. id. 2023] free speech and scientific exchange 337 recently, “the fda has categorically banned manufacturers of drugs and devices from promoting their use for unapproved purposes to the medical profession.”12 although the fda has broad authority to regulate promotional information pertaining to off-label uses by a manufacturer, its authority is limited in the context of scientific speech, discussions, or exchange because of the practice of medicine exception.13 furthermore, the fda recognizes the public health benefit derived from providing “truthful and non-misleading scientific or medical publications on unapproved new uses” to healthcare professionals.14 the fda also acknowledges that “in some specific and narrow areas of medical practice, practitioners consider off-label use to constitute the standard of good medical care.”15 consequently, where investigational (i.e., unapproved) drugs are involved, the fda explicitly allows “the full exchange of scientific information concerning the drug[,]” provided the manufacturer does not make promotional claims about the drug’s safety or effectiveness.16 consequently, where investigational (i.e., unapproved) drugs are involved, the fda explicitly allows “the full exchange of scientific information concerning the drug[,]” provided the manufacturer does not make promotional claims about the drug’s safety or effectiveness.17 likewise, the fda also allows the dissemination of off-label information about an fda-approved drug or device by a manufacturer to an hcp, pharmacy benefit manager, health insurance issuer, group health plan, or regulatory agency that meets all relevant regulatory requirements.18 chief among these requirements is that the information disseminated must be truthful, not misleading and does not 12. see coleen klasmeier & martin redish, off-label prescription advertising, the fda, and the first amendment: a study in the values of commercial speech protection, 37 am. j. l. & med. 315, 320 (2011). 13. the “practice of medicine” exception is well-enshrined in statute and fda regulations. see 21 u.s.c. § 396; 21 c.f.r. § 312.3(d) (2008). the exception allows a prescriber to use a drug or device product for an unapproved indication when the best interests of the patient require it. see u.s. food & drug admin., “off-label” and investigational use of marketed drugs, biologics, and medical devices: guidance for institutional review boards and clinical investigators, 6 (1998); see also u.s. food & drug admin., guidance for industry – responding to unsolicited requests for off-label information about prescription drugs and medical devices: draft guidance, 3 (2011). 14. see u.s. food & drug admin., guidance for industry distributing scientific and medical publications on unapproved new uses — recommended practices: revised draft guidance, 8 (2014); u.s. food & drug admin. memorandum on public health interests and first amendment considerations related to manufacturer communications regarding unapproved uses of approved or cleared medical products, 17 (jan. 2017). 15. washington legal foundation v. friedman, 13 f. supp. 2d 51, 56 (d.d.c. 1998). 16. see 21 c.f.r. § 312.7(a) (2009). 17. friedman, 13 f. supp. 2d at 56. 18. see 21 c.f.r. §§ 99.1(a)(2), 99.101(a), and 99.105 (1998); but see 21 c.f.r. § 99.1(b) (1998) (the regulations do not apply to manufacturer responses to unsolicited requests by hcps). 338 indiana health law review [vol. 20:335 pose a significant risk to public health.19 furthermore, in these situations, the provision of such information is not considered evidence of a manufacturer’s promotion of the product for an “off-label” use.20 iii. first amendment protections in addition to the ffdca, manufacturer speech is subject to free speech guaranteed by the first amendment of the u.s. constitution. freedom of speech states, “congress shall make no law . . . abridging the freedom of speech, or of the press.”21 as the u.s. supreme court articulated, “[t]he protection given speech and press was fashioned to assure unfettered interchange of ideas for the bringing about of political and social changes desired by the people.”22 therefore, “[a]ll ideas having even the slightest redeeming social importance – unorthodox, controversial, and even ideas hateful to the prevailing climate of opinion – have the full protection of the guaranties, unless excludable because they encroach upon the limited area of more important interests.”23 where first amendment protections exist, “[f]reedom of speech presupposes a willing speaker [but] where a speaker exists…the protection afforded is to the communication, source, and recipients.”24 therefore, the first amendment also protects the “right to ‘receive information and ideas.’”25 a. free speech has certain limits however, not all speech is protected by the first amendment. for example, as justice oliver wendell holmes pointed out in 1919, “there is not constitutionally protected right to yell fire in a theatre and cause panic when there is no fire.”26 likewise, the first amendment “does not embrace certain categories of speech, including defamation, incitement, obscenity, or [child] pornography.”27 nor does it embrace false or misleading speech.28 there also is a nexus between speech and conduct. for example, in cox v. louisiana, involving a peaceful protest march and sit-in at segregated lunch 19. 21 c.f.r. §§ 99.101(a)(3), (4). 20. see u.s. food & drug admin., “off-label” and investigational use of marketed drugs, biologics, and medical devices: guidance for institutional review boards and clinical investigators at 6 (1998); see also u.s. food & drug admin., guidance for industry – responding to unsolicited requests for off-label information about prescription drugs and medical devices: draft guidance, 3 (2011). 21. u.s. const. amend. i. 22. see roth v. united states, 354 u.s. 476, 484 (1957). 23. id. 24. see va. state bd. of pharmacy v. va. consumer council, inc., 425 u.s. 748, 756 (1976). 25. see id. at 757 (citing kleindienst v. mandel, 408 u.s. 753, 762-63 (1972)). 26. schenck v. united states, 249 u.s. 47, 52 (1919). 27. ashcroft v. free speech coal., 535 u.s. 234, 246 (2002). 28. va. state bd. of pharmacy, 425 u.s. at 771. 2023] free speech and scientific exchange 339 counters, justice goldberg noted that protestors have no right to cordon off a street or block entrances to buildings to require people to listen to “their exhortations.”29 therefore, “it has not been deemed an abridgment of freedom of speech or press to make a course of conduct illegal merely because the conduct was in part initiated, evidenced, or carried out by means of language; either spoken, written, or printed.”30 enshrined in the concept of free speech is the principle that “the government may not prohibit the expression of an idea simply because society finds the idea itself offensive or disagreeable.”31 therefore, the “regulation of communication may not be affected by sympathy or hostility for the point of view being expressed by the communicator.”32 nevertheless, the supreme court has determined that the first amendment permits “reasonable regulation of speech-connected activities in carefully restricted circumstances.”33 restrictions that target speech based upon content “are presumptively unconstitutional” and are justifiable “only if the government proves that they are narrowly tailored to serve compelling state interests.”34 content restrictions also must satisfy strict scrutiny requirements because the government cannot ban speech merely because it expresses offensive ideas.35 however, where there is a significant governmental interest, the government can impose time, place, and manner restrictions, “provided they are justified without reference to the content of regulated speech.”36 furthermore, the government must ground any restrictions on more than “mere speculation about serious harms.”37 however, the supreme court has noted that “state action to punish the publication of truthful information seldom can satisfy constitutional standards.”38 finally, even when there is a legitimate and compelling interest to restrict or criminalize speech, the context surrounding a 29. cox v. state of louisiana, 379 u.s. 536, 554-55 (1965) (citations omitted). 30. id. (quoting giboney v. empire storage & ice co., 336 u.s. 490, 502 (1949)). 31. texas v. johnson, 491 u.s. 397, 414 (1989) (upholding flag burning as a permitted form of protest); see also roth v. united states, 354 u.s. 476, 484 (1957). 32. young v. am. mini theatres, inc., 427 u.s. 50, 67 (1976) (upholding a zoning ordinance distinguishing between several types of theatres); see also stewart jay, the creation of the first amendment right to free expression: from the eighteenth century to the mid-twentieth century, 34 wm. mitchell l. rev. 773, 774 (2008). 33. see tinker v. des moines indep. cmty. sch. dist., 393 u.s. 503, 513 (1969) (discussing whether the school district could suspend students from wearing black armbands to protest the vietnam war). 34. reed v. town of gilbert, 576 u.s. 155, 163 (2014). 35. matal v. tam, 137 s. ct. 1744, 1751 (2017). 36. see va. state bd. of pharmacy, 425 u.s. at 771; see also bartnicki v. vopper, 532 u.s. 514, 526 (2001) (discussing content neutrality of the federal wiretapping statute). 37. see bartnicki, 532 u.s. at 531 (quoting united states v. treasury emp.’s, 531 u.s. 454, 475 (1995)). 38. id. at 527 (quoting smith v. daily mail publ’g co., 443 u.s. 97, 102 (1979)). 340 indiana health law review [vol. 20:335 particular utterance may abrogate the government’s restriction or punishment.39 b. types of speech until 1942, there was no distinction between commercial and noncommercial speech; there was just speech.40 however, since the mid-1970s, the supreme court has recognized two distinct types of speech—pure and commercial.41 the distinction is essential because the extent to which the government can regulate speech turns on its classification. commercial speech differs from “pure speech” in three critical respects. first, unlike “pure speech,” which typically involves the communication of ideas (e.g., political viewpoints, scientific information, etc.), commercial speech is speech that connects to an individual’s commercial interest (e.g., advertising) or involves something sold for profit (e.g., books).42 thus, in its purest form, commercial speech is “speech which does no more than propose a commercial transaction.”43 however, like pure speech, the supreme court determined that commercial speech provides an essential public benefit worthy of first amendment protection.44 moreover, while protecting pure speech is crucial for “enlightened public democracy,” commercial speech is essential to support “intelligent and well-informed” economic decisions.45 commercial speech is not far removed from the discussion of ideas or from truth and science, unlike defamation, incitement, or obscenity, that it does not deserve protection.46 therefore, commercial speech does not lose first amendment protection because of a commercial context or a purely economic interest.47 second, commercial speech differs from pure speech because commercial speech relates to commercial transactions, an area traditionally subject to government regulation.48 therefore, the supreme court has determined that 39. see watts v. united states, 384 u.s. 705, 708 (1969) (holding that a “threat” against the president was “political hyperbole” because it was made in the context of a vietnam war protest). 40. see valentine v. chrestensen, 316 u.s. 52, 54 (1942); see also note, dissent, corporate cartels, and the commercial speech doctrine, 120 harv. l. rev. 1892, 1892 (2007); steven m. simpson, the commercial speech doctrine: an analysis of the consequences of basing first amendment protections on the “public interest”, 39 n.y. l. sch. l. rev. 575, 575 (1994). 41. see bigelow v. virginia, 421 u.s. 809 (1975); va. state bd. of pharmacy, 425 u.s. at 748. 42. see va. state bd. of pharmacy, 425 u.s. at 762, 765. 43. see id. at 762. 44. see, e.g., pittsburgh press co. v. hum. rel. comm’n, 413 u.s. 376 (1973); bigelow, 421 u.s. at 822; va. state bd. of pharmacy, 425 u.s. at 748; cent. hudson gas & elec. v. pub. serv. comm’n, 447 u.s. 557, 562-563 (1980); bolger v. youngs drug prod.’s corp., 463 u.s. 60 (1983); rubin v. coors brewing co., 514 u.s. 476, 478 (1994). 45. see va. state bd. of pharmacy, 425 u.s. at 765. 46. see id. at 762. 47. see id. at 759, 61; see also bigelow, 421 u.s. at 818. 48. see bolger, 421 u.s. at 64. 2023] free speech and scientific exchange 341 commercial speech is entitled to lesser protection than “pure speech.”49 for example, the government may restrict commercial speech that is more likely to deceive than to inform.50 third, unlike pure speech, the supreme court has outlined a four-part test to evaluate whether government restrictions of commercial speech are permissible under the first amendment. the court in central hudson gas & elec. v. pub. serv. comm’n outlined the well-established test: at the outset, we must determine whether the expression is protected by the first amendment. for commercial speech to come within that provision, it at least must concern lawful activity and not be misleading. next, we ask whether the asserted governmental interest is substantial. if both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted and whether it is not more extensive than is necessary to serve that interest.51 thus, restrictions cannot stand if they provide “only ineffective or remote support for the government’s purpose.”52 nor can restrictions stand if the government’s purpose “could be served as well by a more limited restriction on commercial speech.”53 therefore, the supreme court has “rejected the ‘highly paternalistic’ view that government has the complete power to suppress or regulate commercial speech” because “[e]ven when advertising communicates only an incomplete version of the relevant facts, the first amendment presumes that some accurate information is better than no information at all.”54 this position suggests that even commercial speech that omits some crucial details (i.e., is misleading) might be worthy of some level of first amendment protection. following the central hudson decision, the supreme court has continued to refine the boundaries of permissible government regulation of commercial speech.55 thus, the supreme court rejected governmental attempts to curtail commercial speech in cases involving unsolicited contraceptive advertisements (bolger v. youngs drug products corp.) and beer labeling (rubin v. coors brewing co.).56 49. see pittsburgh press co., 413 u.s. at 376; bigelow, 421 u.s. at 809; va. state bd. of pharmacy, 425 u.s. at 748; central hudson, 447 u.s. at 557; bolger, 463 u.s. at 60 (1983); rubin, 514 u.s. at 478. 50. see central hudson, 447 u.s. at 563 (citations omitted); bolger, 421 u.s. at 65. 51. see central hudson, 447 u.s. at 566. 52. id. at 564. 53. id. 54. id. at 562 (citations omitted). 55. see, e.g., richard parker, central hudson gas and electric corp. v. public service commission (1980), first amend. encyclopedia, https://mtsu.edu/first-amendment/article/ 198/central-hudson-gas-and-electric-corp-v-public-service-commission [https://perma.cc/pn3kkdp3] (last visited feb. 23, 2023). 56. see bolger, 463 u.s. at 75 (“the justifications offered [by the government] are insufficient 342 indiana health law review [vol. 20:335 the supreme court also rejected an attempt by the state of vermont to restrict “data mining” activities to prevent pharmacies from selling or pharmaceutical companies from using prescriber-identifying information for marketing purposes without the prescriber’s consent.57 the court found that the law was content-based and, in practice, viewpoint discriminatory.58 therefore, the statute was not a “mere commercial regulation.”59 iv. two worlds collide following the supreme court’s pure and commercial speech rulings, the stage was set for a series of challenges to the fda’s claimed authority to regulate off-label promotion (i.e., speech) by drug and device manufacturers. like the supreme court in central hudson, bolger, rubin, and sorrell, the courts in these cases rejected the fda’s sweeping claims of authority to restrict manufacturer speech about off-label product uses. in 1998, the washington legal foundation challenged guidance documents issued by the fda that sought to restrict “certain forms of manufacturer promotion of off-label use for fda-approved drugs and devices.”60 the fda’s guidance documents contained restrictions on the dissemination of medical textbooks and peer-reviewed articles, as well as industry involvement in continuing medical education (“cme”) programs.61 the fda argued that based on the need to “strike the proper balance between the need for an exchange of reliable scientific data and information within the health care community, and the statutory requirements that prohibit companies from promoting products for unapproved uses[,]” there was a substantial government interest.62 additionally, the agency contended that the speech covered by the guidance documents fell outside of the first amendment because of the fda’s “extensive power to regulate the pharmaceutical industry.”63 the d.c. district court rejected those propositions as being of questionable validity.64 according to the district court, the first amendment rules must apply to warrant the sweeping prohibition on the mailing of unsolicited contraceptive advertisements.”); rubin, 514 u.s. at 490 (finding batf’s regulation was not sufficiently tailored to meet its goal in a direct and meaningful way). 57. see sorrell v. ims health inc., 564 u.s. 552, 574 (2011) (free speech limitations cannot stand “when the options provided by the state are too narrow to advance legitimate interests or too broad to protect speech.”). 58. id. at 571. 59. id. at 566. 60. see friedman, 13 f. supp. 2d at 54. 61. see final guidance on industry-supported scientific and educational activities, 62 fed. reg. 64074 (1997); advertising and promotion guidance, 61 fed. reg. 52800-02 (1996). 62. friedman, 13 f. supp. 2d at 58. 63. see id. at 60. 64. id. 2023] free speech and scientific exchange 343 if the speech is about a lawful activity and not misleading.65 in rejecting the fda’s contention that off-label speech is about illegal activities, the court noted: the proper inquiry is not whether the speech violates a law or a regulation but whether the conduct that the speech promotes violates the law . . . therefore, only at such time as off-label prescriptions are proscribed by law could the fda legitimately claim that the speech at issue addresses “illegal activities.”66 in other words, the fda’s power may be limited to “off-label” speech that results, or may result, in an illegitimate prescription (e.g., medically unnecessary). furthermore, judge lamberth, in an often-quoted passage, wrote “[i]n asserting that any and all scientific claims about the safety, effectiveness, contraindications, side effects, and the like regarding prescription drugs are presumptively untruthful or misleading until the fda has had the opportunity to evaluate them, fda exaggerates its overall place in the universe.”67 while the district court concluded that the fda’s interests in protecting the public are substantial, the agency’s approaches were “more extensive than necessary to serve the asserted government interest and that they unduly burden important speech.”68 therefore, the fda could not prevent manufacturers from disseminating peer-reviewed journal articles or medical textbooks discussing offlabel uses or suggesting content or speakers at cme programs.69 however, the office of inspector general for the u.s. department of health and human services (“hhs-oig”) has highlighted potential kickback issues with industrysponsored speaker and cme programs, suggesting that the government can raise other non-first amendment concerns.70 although friedman held that speech about drug and device off-label uses was not per se illegal, the fda, in 2005, proceeded to target alfred caronia, a pharmaceutical sales representative, for making off-label promotional statements.71 before his trial, caronia moved to dismiss the charges.72 however, the district court for the eastern district of new york rejected his motion, ruling that,”[i]f, as the manufacturer’s representative, caronia promoted xyrem for offlabel uses, whatever information (accurate or inaccurate) caronia may have provided in the course of the promotion of those off-label uses is irrelevant to a 65. see id. at 61 (“fda’s argument that it may freely limit [a manufacturer’s free speech] because of the government’s broad power to regulate the food and drug industry does not comport with current first amendment jurisprudence, and therefore must be rejected.”). 66. see id. at 66. 67. id. at 67. 68. id. at 74. 69. id. 70. see u.s. dep’t of health & hum. serv’s, off. of inspector gen., oig advisory opinion 22-14 (june 29, 2022); u.s. dep’t of health & hum. serv’s, off. of inspector gen., special fraud alert: speaker programs (nov. 16, 2020). 71. see united states v. caronia, 703 f.3d 149, 149 (2d cir. 2012). 72. see united states v. caronia, 576 f. supp. 2d 385, 385 (e.d.n.y. 2008). 344 indiana health law review [vol. 20:335 misbranding charge.”73 based on the court’s reasoning, simply making “off-label” promotional statements about a drug meant caronia was guilty of misbranding.74 caronia was convicted at trial even though the government did not argue that caronia’s statements were either false or misleading.75 however, on appeal, the second circuit court of appeals rejected the trial court’s reasoning and noted that the ffdca does not expressly prohibit or criminalize off-label promotion. instead, the statute and its accompanying regulations only discuss “promotion” in terms of evidence of a drug’s intended use.76 thus, consistent with friedman, the court concluded that the promotion of a drug off-label “is not in and of itself false or misleading,” nor is the use of a drug off-label per se illegal, given the latitude the fda grants to prescribers (i.e., the practice of medicine exception).77 finally, the court, relying on sorrell,78 concluded that “the government’s construction of the ffdca to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests.”79 therefore, the second circuit determined the fda can no longer support a misbranding prosecution simply because the statements were “off-label,” but rather must show that the statements were either false or misleading. following the caronia decision, the u.s. district court for the southern district of new york held that amarin could “engage in truthful and nonmisleading speech promoting the off-label use of [its product, and] such speech may not form the basis of a prosecution for misbranding.”80 later in 2015, pacira pharmaceuticals, inc., and the fda settled a similar case where the fda agreed to withdraw its warning letter and approve new labeling allowing pacira to make truthful and non-misleading product claims.81 finally, in 2016, the fda was forced to admit in a subsequent off-label prosecution involving medical devices that it “is . . . not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”82 73. see id. at 392. 74. see united states v. caronia, 703 f.3d 149, 158-59 (2d cir. 2012). 75. see id. at 165 n.10. 76. id. at 160. 77. see id. at 165-66. 78. see id. at 162 (speech in connection with pharmaceutical marketing is protected under the first amendment) (citation omitted). 79. id. at 167. 80. see amarin pharma, inc. v. u.s. food & drug admin., 119 f. supp. 3d 196, 237 (s.d.n.y. 2015). 81. see stipulation and order, pacira pharm., inc. v. u.s. food & drug admin., 15 civ. 7055 (lak) (s.d. n.y. dec. 15, 2015). 82. proposed jury instructions, united states v. vascular solutions, inc., no. sa:14-cr-926rcl (w.d. tex. jan. 7, 2016). 2023] free speech and scientific exchange 345 v. fda “doubles down” on its position the decisions in the friedman, caronia, amarin, pacira, and vascular solutions cases should have settled the limits of the fda’s authority over manufacturer speech. based on those cases, the fda can only assert authority when the information is false or misleading or where a manufacturer in a commercial context actively promotes a product for off-label use. thus, the fda does not have regulatory authority to limit legitimate (i.e., truthful, nonmisleading, and non-promotional) scientific exchanges between manufacturers and other parties. despite these decisions, the fda has steadfastly maintained that the agency has almost unlimited regulatory authority to address any off-label speech. it has done so by failing to address two citizens petitions and redefining the longsettled concept of intended use. in 2011, and again in 2013, two groups of pharmaceutical companies petitioned the fda seeking further clarity on its policies surrounding new uses of marketed drugs and devices and other regulatory terms.83 for example, the petitioners wanted clarity on the scope of “scientific exchange” and labeling, advertising, and intended use through formal regulations.84 they also advocated that the fda review its policies considering the supreme court’s free speech cases and the second circuit’s caronia ruling.85 thus, they urged the fda to ensure that any policies it developed “adequately respect statutory and constitutional limitations.”86 to date, the fda has rejected the requests in the petitions, choosing instead to focus on redefining “intended use.”87 the intended use revision was buried in a 2017 final rule clarifying how the fda would regulate tobacco-derived products and was a surprise to the industry.88 in that final rule, the fda added a new standard. based on the final 83. see citizen pet., alan r. bennett & paul e. kalb et al., to div. of dockets mgmt., u.s. food & drug admin. at 1 (july 5, 2011) (submitted on behalf of allergan, inc.; eli lilly & co.; johnson & johnson; novartis pharm. corp.; and novo nordisk, inc.) [hereinafter “cp 2011”]; see also citizens pet., alan r. bennett & paul e. kalb et al., to div. of dockets mgmt., u.s. food & drug admin. (sept. 3, 2013) (submitted on behalf of allergan, inc.; bayer healthcare pharm., inc.; boehringer ingelheim pharm., inc.; eli lilly & co.; genentech, inc.; glaxosmithkline llc; johnson & johnson; novartis pharm. corp.; novo nordisk, inc.; pfizer, inc.; purdue pharma l.p.; and sanofi us) [hereinafter “cp 2013”]. 84. see cp 2011, supra note 82, at 7, 9; cp 2013, supra note 82, at 13-19. 85. see cp 2013, supra note 82, at 2 (citing sorrell v. ims health inc., 564 u.s. 552 (2011); fcc v. fox television stations, inc., 567 u.s. 239 (2012); caronia, 703 f.3d 149 (2d cir. 2012)). fox held that regulated parties should know what is required of them, and precision and guidance is necessary to prevent arbitrary or discriminatory enforcement. although the petition was filed in 2012, fda’s review would now include amarin, pacira, and vascular solutions. 86. see cp 2013, supra note 82, at 3. 87. see 21 c.f.r. §§ 201.128 & 801.4. 88. see clarification of when products made or derived from tobacco are regulated as 346 indiana health law review [vol. 20:335 rule, the fda now defined “intended use” as follows: if the totality of the evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required . . . to provide for such drug adequate labeling that accords with such other intended uses.89 from the perspective of regulating scientific speech, the “totality of the evidence” standard presented a new dimension in evaluating intended use, and as argued by the medical information working group (miwg) in a 2017 citizen petition, not only is “totality of the evidence” not found in the ffdca, but it “allows the fda to consider any evidence, including knowledge” when making an intended use determination.90 the fda acknowledged this expansion in the rule’s preamble but refused to “narrow the scope of evidence it will consider for intended use.”91 to justify its refusal, the fda asserted that narrowing the scope of intended use would not only create a loophole for manufacturers and distributors to evade fda oversight of the marketing of approved/cleared medical products for unapproved uses but would also open the door to the marketing of wholly unapproved medical products—all to the detriment of the public health.92 the final rule also reignited the first amendment debate concerning the limits of the fda’s authority to regulate scientific (and promotional) speech. here, the fda refused to limit its expansive interpretation considering the central hudson and caronia cases, stating that: we do not agree with the assertion that the current case law allows fda to consider speech as evidence of intended use only when it is false or misleading, “because the first amendment ‘does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.’”93 therefore the “use of speech to infer intent, which in turn renders an otherwise drugs, devices, or combination products; amendments to regulations regarding ‘’intended uses,” 82 fed. reg. 2193 (jan. 9. 2017); see also pet. to stay & for reconsideration from paul kalb et al., to div. of dockets mgmt. at 2, u.s. food & drug admin. (feb. 8, 2017) (submitted on behalf of the miwg, the pharm. res. & mfr. of am., and the biotechnology innovation org. asserting the revisions were not communicated to the public prior to publishing the final rule in violation of the administrative procedure act (“apa”)). 89. 82 fed. reg. at 2217 (to be codified at 21 c.f.r. § 201.128). 90. see pet. to stay, supra note 89, at 12. 91. 82 fed. reg. at 2207. the several types of evidence cited included “advertising; press statements; official or unofficial statements made by corporate officials; statements made in social media and other online arenas; and statements made in point-of-sale locations, both traditional retail and online.” id. 92. id. 93. id. at 2209 (quoting wisconsin v. mitchell, 508 u.s. 476, 489 (1993)). 2023] free speech and scientific exchange 347 permissible act unlawful, is constitutionally valid.”94 the fda argued that because it had a substantial interest in protecting the public health and safety delegated to it by congress, the fda’s regulatory policies were justified because “in other cases, the use of approved/cleared medical products for unapproved uses has also been associated with significant harm to patients, fraud, and waste of health care resources.”95 likewise, the fda rejected the contention that heightened judicial scrutiny should apply to truthful and non-misleading speech, arguing that sorrell held that sometimes contentbased restrictions on protected expressions are permitted.96 going further, the fda stated, “in reed v. town of gilbert, the court applied strict scrutiny to content-based restrictions on non-commercial speech in public fora. that holding has no bearing on the commercial speech at issue here.”97 in 2021, the fda reasserted that any speech by a manufacturer is “commercial speech,” as outlined by central hudson and its progeny.98 the fda argued that: the key issue in the intended use analysis is whether the evidence is “relevant,” which does not necessarily depend on whether there is evidence of “promotional” activity. . . accordingly, fda declines the suggestion to include “promotional” as a limiting principle for nonclaims-based evidence that may be relevant to intended use.99 the fda also contended that the “intended use regulations describe evidence that may be relevant to establishing intended use; they do not in themselves directly regulate speech.”100 the fda’s assertation of almost unbridled authority to restrict truthful, nonmisleading scientific speech by manufacturers contains several flaws and is inconsistent with the applicable case law. for example, based on its redefinition of “intended use,” the fda considers all manufacturer speech commercial speech. however, the supreme court has not made such a determination. furthermore, the fda’s claim is at odds with the supreme court’s holding in sorrell, which concluded that “vermont’s law [prohibiting the sale of prescriber-identifying data by data miners] does not simply have an effect on speech but is directed at certain content and is aimed at particular speakers.”101 here, the intended use determination is directed at certain content (promotional and scientific information about off-label uses) and is aimed at a particular type of speaker (manufacturers). 94. id. (quoting whitaker v. thompson, 353 f.3d 947, 953 (d.c. cir. 2004)). 95. id. at 2210. 96. see id. at 2211. 97. id. (referencing reed, 576 u.s. at 178). 98. see regulations regarding “intended use,” supra note 9. in 2021, the fda reopened the docket in response to the miwg’s 2017 petition, id. at 41385. 99. id. at 41390. 100. id. at 41391. 101. see sorrell, 564 u.s. at 567. 348 indiana health law review [vol. 20:335 vi. fda’s claims of expansive authority are flawed when evaluating government restrictions on speech, the supreme court has ruled that the distinction between pure or commercial speech is relevant for determining the level of judicial scrutiny to apply.102 unlike commercial speech, the supreme court has not articulated a standard approach for analyzing “pure speech” cases. however, no matter the type of speech at issue, “it is the [government’s] burden to justify its content-based law [is] consistent with the first amendment.”103 this requirement suggests the four-part test from central hudson is a proper standard for analyzing the fda’s asserted authority to regulate manufacturer scientific discussions, whether they are deemed “pure” or commercial speech given the government’s identical burden.104 a. first amendment protections apply to scientific discussions based on the supreme court’s analysis in virginia pharmacy board, manufacturer scientific discussions, whether commercial or pure speech, which does not involve false or misleading information, are worthy of a certain level of free speech protection. this is because scientific discussions fit squarely into the supreme court’s view that speech includes the exposition of ideas, including truth, science, morality, the arts, or the “diffusion of liberal sentiments on the administration of government.”105 thus, speech casts a long shadow, and scientific discussions about commercial drugs or medical devices, even if initiated by a manufacturer, fall within that shadow. furthermore, scientific discussions are not per se illegal, even if the content involves discussions about off-label or uncleared uses.106 manufacturer scientific discussions can become illegal if they are false, misleading, or used by manufacturers to promote a product for an unapproved or uncleared use.107 however, scientific exchange is permitted absent facts establishing that a manufacturer or their representatives are engaging in scientific discussions as a 102. id. at 571. 103. see id. at 571–72. 104. manufacturer scientific discussions, however, do not fall under the fda’s new rubric of “consistent with the fda-required labeling (cfl),” because cfl is “limited to information about the approved or cleared uses of a product.” see u.s. food & drug admin., medical product communications that are consistent with the fda-required labeling questions and answers: guidance for industry 1, 1 (2018), https://www.fda.gov/media/133619/download [https://perma.cc/ 3f85-wcge]. 105. see va. pharm. bd., 425 u.s. at 759-62. 106. see, e.g., friedman, 13 f. supp. 2d at 66; caronia,703 f.3d at 165-66; 21 u.s.c. §§ 352(a)(1), (f) and 321(n); 21 c.f.r. 312.7(a). 107. see, e.g., friedman,13 f. supp. 2d at 66; caronia, 703 f.3d at 165-66; 21 u.s.c. §§ 352(a)(1), (f) and 321(n); 21 c.f.r. 312.7(a); see also va. pharm. bd., 425 u.s. at 748; cent. hudson gas & elec., 447 u.s. at 557; bolger, 463 u.s. at 60. 2023] free speech and scientific exchange 349 pretext to provide false information or unlawfully promote their products.108 even the fda concedes this point and acknowledges a public health benefit from scientific exchange.109 b. scientific discussions must be considered pure speech unlike political speech or product advertisements, scientific discussions do not fall neatly within either pure or commercial speech like the types of speech involved in the supreme court’s rulings. therefore, although scientific exchange is subject to free speech protections, the lack of a clear delineation between pure and commercial speech makes it difficult to determine the extent of those protections. for example, in the virginia pharmacy board case, the supreme court defined commercial speech as “speech which does no more than propose a commercial transaction.”110 under this definition, product advertisements are the clearest examples of commercial speech. however, as in the bigelow case, which involved abortion advertisements in a newspaper, the supreme court struggled with the pure versus commercial speech distinction.111 one can argue that there is a commercial connection surrounding scientific discussion since the discussions are about the uses of a product the manufacturer sells or plans to sell in the marketplace. however, it is disingenuous to claim that scientific discussions do no more “than propose a commercial transaction.” as the fda concedes, these discussions are essential to provide prescribers with the evidence to make sound medical decisions for their patients.112 thus, manufacturers often have large bodies of data about their products and have the most current and accurate information essential to inform the prescriber’s decisions.113 manufacturer scientific discussions also do not fall cleanly into the “pure 108. see, e.g., watts, 394 u.s. at 708 (requiring the government to factually establish a threat existed); see also caronia, 703 f.3d at 167 (admonishing the fda for asserting that all scientific claims are “presumptively untruthful or misleading until the fda has had the opportunity to evaluate them.”). 109. see 21 c.f.r. §§ 99.1(a)(2), 99.101(a), 99.105, and 312.7(a) (2022); see also u.s. food & drug admin., guidance for industry distributing scientific and medical publications on unapproved new uses — recommended practices: revised draft guidance 1, 8 (2014), https://www.fda.gov/media/88031/download [https://perma.cc/3vzy-42nh]; clarification of when products made or derived from tobacco are regulated as drugs, devices, or combination products; amendments to regulations regarding ‘’intended uses,’‘ 82 fed. reg. 2193, 2210 (jan. 9. 2017). 110. see va. pharm. bd., 425 u.s. at 762. 111. see bigelow, 421 u.s. at 818 (discussing bigelow’s commercial interests); but cf. id. at 817 (noting that his claim involved pure speech). 112. see friedman, 13 f. supp. 2d at 56 (“in some specific and narrow areas of medical practice, practitioners consider off-label use to constitute the standard of good medical care.”). 113. see, e.g., fda unsolicited request guidance, supra note 13, at 2-3. 350 indiana health law review [vol. 20:335 speech” category. while scientific discussions expound on ideas, they are not political speech like the anti-war rhetoric in watts.114 nor are manufacturer scientific discussions symbolic speech like the armbands in tinker.115 finally, manufacturers are not media outlets like the parties in the cox and bartniki.116 however, as the fda acknowledges,117 like speech by media outlets, manufacturer scientific discussions contain information that is of substantial public interest and concern.118 since manufacturer scientific discussions do not fall cleanly within the binary classification of “pure” or commercial speech or another hybrid designation, declaring scientific discussions are pure speech, best aligns the supreme court’s free speech rulings with the lower court rulings in friedman and caronia. the fda takes a contrary position, arguing that all manufacturer speech is commercial speech.119 however, the agency’s position ignores the supreme court’s decisions in watts and bartnicki that context matters when evaluating free speech restrictions.120 it also ignores the friedman ruling that not all scientific discussions are false or misleading unless approved by the fda.121 the fda’s belief that manufacturer scientific discussions are commercial speech also is inconsistent with the current industry practice outlined by the hhsoig and the u.s. department of justice (doj) to separate medical affairs responsibility for scientific discussions from a manufacturer’s commercial functions.122 however, where manufacturers fail to maintain the required separation, the doj and hhs-oig have asserted that manufacturer scientific discussions become de facto commercial speech and are subject to the fda’s restrictions on promotional (i.e., commercial) speech.123 nonetheless, even if 114. see watts, 394 u.s. at 708. 115. see tinker, 393 u.s. at 513. 116. see cox, 379 u.s. at 555 (1965); bartnicki, 532 u.s. at 519. 117. see, e.g., fda unsolicited request guidance, supra note 13, at 2-3. 118. see, e.g., bartnicki, 532 u.s. at 518. 119. see, e.g., 82 fed. reg. 2211. 120. see watts, 394 u.s. at 708 (ruling that the speech when taken in context was political hyperbole and not a threat). 121. friedman, 13 f. supp. 2d at 67. (“fda exaggerates it overall place in the universe.”). 122. see oig compliance program guidance for pharm. mfr., 68 fed. reg., 23731, 23735-36 (may 5, 2003) (discussing the need to separate educations grants and research funding awards from marketing); corporate integrity agreement between the off. of inspector gen. of the dep’t of health & hum. serv., and allergan, inc. 11 § 3.b.3.h (sept. 1, 2010), https://www.sec.gov/ archives/edgar/data/850693/000119312510202820/dex102.htm [https://perma.cc/ln6k-sfn7]; corporate integrity agreement between the off. of inspector gen. of the dep’t of health & hum. serv., astrazeneca pharmaceuticals lp, and astrazeneca lp, 11 §§ iii.b.3(g-h) (may 2011), http://psychrights.org/2010/100427astrazenecacorpintegrityagmt.pdf [https://perma.cc/7ld6ezyj]. 123. see, e.g., corporate integrity agreement between the off. of inspector gen. of the dep’t of health & hum. serv., and glaxosmithkline llc, 42-43 § iii.m.4 (june 2012), https://www. justice.gov/sites/default/files/opa/legacy/2012/07/02/plea-ex-d.pdf [https://perma.cc/p6y6-kd7y]. 2023] free speech and scientific exchange 351 scientific discussions are transformed into commercial speech by the manufacturer’s actions, first amendment commercial speech protections would still apply.124 c. fda has a limited government interest regardless of whether manufacturer scientific discussions are considered pure or commercial speech, the fda must establish the existence of a substantial government interest to justify limitations or restrictions that impinge on free speech.125 over the years, the fda has postulated a variety of justifications to support its restrictions on manufacturer speech. although some justifications have merit, others do not. for example, the fda asserts that congress enacted the ffdca partly to protect the public from harm caused by unsafe or ineffective treatments.126 therefore, the agency has repeatedly argued that its regulatory policies are justified because, in some cases, “the use of approved/cleared medical products for unapproved uses has also been associated with significant harm to patients, fraud, and waste of health care resources.”127 while the fda has a governmental interest in protecting the public from fraud or misrepresentations by a product’s manufacturer, the free speech cases establish that such an interest does not automatically give the government unlimited authority to restrict entire categories of speech.128 nor can the government impose restrictions based on speculation or conjecture, but instead must show the harms are real and its proposed restrictions will alleviate them “to a material degree.”129 the fda also asserts it has a substantial interest in “motivating the development of robust scientific data on safety and efficacy.”130 while this is undoubtedly true, it implies that the fda’s market application process is the only way to ensure the development of that data; a presumption rejected by the friedman court.131 124. see, e.g., caronia, 703 f.3d at 149; amarin pharma, inc. v. u.s. food & drug admin., 119 f. supp. 3d 196, 237 (s.d.n.y. 2015). 125. see central hudson gas & elec., 447 u.s. at 563 (1980); bolger, 463 u.s. at 65; rubin, 514 u.s. at 485-86. 126. see u.s. food & drug admin. mem., on public health interests and first amendment considerations, supra note 14, at 1. 127. see 82 fed. reg. 2210. 128. see sorrell, 564 u.s. at 572 (2011); bolger, 463 u.s. at 64 (declaring that the government has no power to restrict speech because of its messages, ideas, subject matter, or content); rubin, 514 u.s. at 487 (providing a limit that even where the government has a substantial interest, the regulation must advance that interest “in a direct and meaningful way”). 129. see rubin, 514 u.s. at 487 (citation omitted). 130. see u.s. food & drug admin. memorandum on public health interests and first amendment considerations, supra note 14, at 3. 131. see friedman, 13 f. supp. 2d at 67; amarin pharma, inc., 119 f. supp. 3d at 250. 352 indiana health law review [vol. 20:335 next, the fda asserts it has an interest in protecting against bias.132 bias is inherent in developing scientific hypotheses, especially when prescribers deem using a product off-label is in their patients’ best interests. certainly, bias that tips the balance and results in false or misleading information is inappropriate. nevertheless, under the existing statutory provisions, the fda already has the means to address these situations.133 thus, the type of “bias” at issue here is unclear. finally, the fda asserts an interest in ensuring the “integrity and reliability of promotional information regarding medical product uses.”134 this justification, however, only applies to promotional information and not scientific exchange. furthermore, the fda’s position exaggerates the scope of the agency’s jurisdiction if “integrity and reliability” mean more than being truthful and nonmisleading.135 d. fda has limited restrictive options assuming the fda successfully establishes a substantial government interest, the agency’s options to limit manufacturer scientific discussions beyond restricting false or misleading information are limited. when determining what options are available, it is easier to determine what the fda cannot do. first, the fda cannot impose a complete ban on manufacturer scientific discussions or communications. this limitation is valid regardless of whether manufacturer scientific discussions are considered “pure” speech136 or commercial speech.137 to be fair, the agency has never considered a complete ban on manufacturer scientific discussions and has continued reaffirming the potential public health benefits of these discussions. therefore, any attempt by the fda to impose a complete ban is improbable. however, given the fda’s innate skepticism about manufacturers’ motives, the agency will continue to assert the right to impose restrictions on manufacturer scientific speech. second, the fda may not favor one form of speech over another.138 in other words, the fda cannot allow oral representations but restrict written communications if the content is the same, but the purposes are different.139 132. see friedman, 13 f. supp. 2d at 67; sorrell, 564 u.s. at 572; caronia, 703 f.3d at 167. 133. see, e.g., 21 u.s.c. § 331(a) (misbranding); 21 u.s.c. § 352(f); u.s. food & drug admin., demonstrating substantial evidence of effectiveness for human drug and biological products: draft guidance for industry (2019). 134. see u.s. food & drug admin. memorandum on public health interests and first amendment considerations, supra note 14, at 3. 135. see, e.g., friedman, 13 f. supp. 2d at 67. 136. see tinker, 393 u.s. at 513; and bartnicki, 532 u.s. at 527. 137. see bigelow, 421 u.s. at 809; va. pharm. bd., 425 u.s. at 748; central hudson gas & elec., 447 u.s. at 557; bolger, 463 u.s. at 60; sorrell, 564 u.s. at 578-80. 138. cox, 379 u.s. at 536; tinker, 393 u.s. at 513; bartnicki, 532 u.s. at 527. 139. see bolger, 463 u.s. at 60 (restricting only mailers with a commercial interest). 2023] free speech and scientific exchange 353 furthermore, the fda may be limited in its ability to restrict speech based on different types of speakers (e.g., a manufacturer versus an independent medical professional).140 third, any applied restrictions must consider the context surrounding the speech.141 in the case of intended use, the fda has conceded as much, noting that intended use turns on whether “the manufacturer objectively intends” the product to be used off-label.142 thus, the agency must evaluate the “totality of the evidence” (i.e., the context) and not just the actual statements made by the manufacturer. because manufacturer scientific discussions are pure speech, the supreme court in bolger was quite clear that “the first amendment means that government has no power to restrict [the] expression because of its message, its ideas, its subject matter, or its content.”143 while the fda might be able to impose reasonable time, place, and manner restrictions, any restrictions must be minimal to avoid impinging on content.144 however, it is difficult to imagine the fda imposing time, place, or manner restrictions that would neither target particular speakers nor content. however, if manufacturer scientific discussions are commercial speech, based on the supreme court’s central hudson and sorrell rulings, the fda still lacks “the complete power to suppress or regulate” these discussions.145 furthermore, based on caronia, a court should view attempts by the fda to criminalize truthful and non-misleading scientific discussions by manufacturers as more extensive than is needed to address the government’s legitimate interests.146 in addition, the friedman and caronia cases stand for the proposition that the fda has limited authority to restrict truthful or non-misleading speech by manufacturers over a wide range of activities.147 therefore, while there is yet to be a definitive supreme court test of the fda’s authority to regulate manufacturer scientific speech, a fair reading of the cases suggests that the fda’s authority is limited to regulating only false or misleading discussions. as the supreme court concluded in virginia pharmacy board and sorrell, the government may not simply ban speech it does not like or is fearful about its 140. caronia, 703 f.3d at 167 (sales representative versus independent hcp). 141. see watts, 394 u.s. at 708 (finding the speech to be political hyperbole in the situation); bartnicki, 532 u.s. at 528 (right of the press to publish information of great public concern regardless of how it was obtained); friedman, 13 f. supp. 2d at 67 (rejecting the fda’s contention that all scientific claims not reviewed by the agency are presumptively false or misleading). 142. 82 fed. reg. 2217 (2017). 143. see bolger, 463 u.s. at 65 (citation omitted); sorrell, 564 u.s. at 572 (content-based or viewpoint discriminatory restrictions are not permitted) (citation omitted). 144. see va. pharm. bd., 425 u.s. at 771; cox, 379 u.s. at 554-55. 145. see central hudson, 447 u.s. at 562, 63; sorrell, 564 u.s. at 570. 146. see caronia, 703 f.3d at 149. 147. see friedman, 13 f. supp. 2d at 74 (peer-reviewed journal articles, medical textbooks, cme programs); caronia, 703 f.3d at 165-66 (sale representative statements). 354 indiana health law review [vol. 20:335 effect on recipients.148 vii. divining the future the future of the fda’s attempt to limit manufacturer scientific discussions is by no means certain. the only clear pathway to determine the boundaries of the fda’s authority will require a supreme court decision on whether manufacturer scientific discussions are “pure” speech, commercial speech, or some new, yet undefined, hybrid. from a timing perspective, such a case will take years to work its way through the federal judicial system. in the meantime, the fda will persist in asserting that all manufacturer speech, promotional and scientific, is commercial speech. in addition, the agency will continue using “intended use” to limit those discussions. thus, it is unlikely that the fda will address the concerns raised by the 2011 and 2013 citizens petitions. in doing so, we expect the fda will continue arguing that “intended use” is not a restriction on speech but an evidentiary standard even though, in practice, it amounts to a free speech restriction. furthermore, using the new expansive “totality of evidence” standard, the agency could attempt to characterize legitimate scientific discussions as objective evidence of the manufacturer’s intent about the product.149 however, other non-free speech developments could potentially challenge the fda’s continued broad interpretation of its authority. for example, in 2019, the supreme court in kisor v. wilkie noted that deference to an agency’s interpretation of its own rules is not absolute but must be reasonable and fall within the bounds of reasonable interpretation.150 the supreme court also recently determined that an agency’s regulations must have a “textual basis” in the statute.151 the american hospital association v. becerra case suggests that the fda’s interpretations and creation of new concepts, such as its consistent with the fda-required labeling (cfl),152 must be grounded on the congressional grant of authority in the ffdca.153 furthermore, the fda’s steadfast refusal to clarify its positions as outlined by the citizens petitions casts doubt on the agency’s regulatory policies concerning scientific discussions and intended use. in safeco insurance co. of america v. burr and federal communications commission v. fox television stations, the supreme court determined that a defendant’s reasonable statutory 148. see va. pharm. bd., 425 u.s. at 773; sorrell, 564 u.s. at 578-80. 149. see, e.g., 82 fed. reg. 2217 (2017). 150. see kisor v. wilkie, 139 s. ct. 2400, 2415 (2019). 151. see am. hosp. ass’n v. becerra, no. 20-1114, 8 (june 15, 2022) (rejecting hhs’s 340b reimbursement changes for participating hospitals). 152. see 83 fed. reg. 27602 (june 13, 2018). 153. see becerra, supra note 152, at 11-12 (discussing the interplay between statutory language and an agency’s interpretation of its authority under the statute). 2023] free speech and scientific exchange 355 interpretations are not actionable without authoritative guidance to the contrary.154 various circuit courts of appeals have adopted this standard and applied it to federal false claims act cases.155 although safeco and fox have yet to be used in the context of the fda’s regulatory policies, we believe the supreme court would take a similar tack if confronted with this question. viii. dealing with ambiguity absent the resolution of whether manufacturer scientific discussions are commercial or “pure” speech, we believe that manufacturers should treat scientific discussions as commercial speech. doing so mitigates the risk that the courts grant the fda discretion to impose restrictions under the commercial speech doctrine or attempts by the fda to use scientific discussions as evidence of “intended use” applying the new “totality of the evidence” standard. therefore, manufacturers should continue to separate scientific from commercial discussions and restrict commercial personnel from engaging in scientific discussions. it is safer to let clinical or medical affairs personnel in the r&d function handle scientific discussions. manufacturers also should institute internal controls (e.g., legal, medical, and regulatory (“lmr”) review) to ensure that scientific discussions involve only truthful and non-misleading information. for example, manufacturers should avoid materials that lack fair balance (i.e., only report favorable information that discounts product risks or negative clinical trial results). manufacturers also should avoid discussions of poorly designed or conducted studies. although using unabridged, peer-reviewed medical or scientific journal articles reduces the risk, it does not absolve manufacturers from needing to review the materials’ quality before disseminating them. finally, since the fda may consider scientific information misleading in some contexts, manufacturers should distribute this information, primarily if it discusses “off-label” uses, with appropriate disclaimers. for example, the information should highlight that the fda does not approve the “off-label” uses and that it may not be “consistent with the fda-required labeling.” manufacturers should also clarify that the information is being disseminated for scientific discussion, not product promotion. ix. conclusion with the rapid pace of healthcare innovations and new therapies, the need for 154. see safeco insurance co. v. burr, 551 u.s. 47, 69-70 (2007); federal commc’n’s comm’n v. fox television stations, 567 u.s. 239, 253-254 (2012). 155. see, e.g., united states ex rel. schutte v. supervalu inc., 9 f.4th 455, 472 (7th cir. 2021)); united states ex rel. sheldon v. allergan sales, llc, 49 f.4th 873, 874 (4th cir. 2022); see also laura mclane et al., when a law is ambiguous and a defendant’s interpretation makes sense: fourth circuit rejects fca “liability through ambush,” vol. xiii, no. 95 nat’l l. rev. (2022), available at https://www.natlawreview.com/article/when-law-ambiguous-and-defendant-sinterpretation-makes-sense-fourth-circuit-rejects [https://perma.cc/4xc9-2aq3]. 356 indiana health law review [vol. 20:335 wide-ranging and transparent manufacturer scientific discussions has never been greater. however, the fda’s continued regulation of these discussions is not aligned with current free speech protections. furthermore, it remains an open question whether manufacturer scientific discussions constitute “pure” or commercial speech and the extent to which the fda can regulate them. in the absence of a definitive supreme court ruling on the topic, it is left to manufacturers to determine the limits and the degree of risk a company wishes to assume. however, as discussed, manufacturer scientific discussions are best classified as “pure speech,” thus limiting the fda’s regulatory authority to addressing only false or misleading scientific information. the legal battle with the future of autonomous surgical robotics andrew villanueva i. introduction in a world where technology has never stood still, nor stopped developing, the law has always been in the rearview mirror.1 thus, resulting in a strong need to develop, regulate, and enforce laws, statutes, and regulatory bills that are associated with advanced technology.2 with rapid advancements of artificial intelligence and autonomous robotics within the private lives of citizens and the public sectors of companies, the realm of law is in need of solutions of how to handle the legal repercussions of such a rapid succession of technological change.3 the advancement from partial autonomous robotics into the futuristic notion of fully autonomous surgical robotics will create new areas of legal problems and concerns that should be addressed before they arise.4 this need for a preemptive solution is based on the risk of health and lives associated with the medical practice and the whole realm of medicine.5 it remains to be seen whether robotic systems will be regulated and how they will be handled within the legal system.6 ronald lees and his fellow researchers determined that there are four factors that need to be considered when addressing any and/or all future legal issues arising out of advanced surgical robotics: “law, market, social norms, and technology.”7 each presenting a key consideration that should contribute to the formulation of relevant statutes or legal precedents.8 in any case, with or without proper regulations and statutory law, robotic technology has already begun to revolutionize surgery by improving, expanding, and developing procedures, by advancing surgical technology and bringing surgery into the digital age.9 as the future continues to draw near, the reality of further ability of semi-autonomous robotics being present in our society and 1. see daniel malan, the law can't keep up with new tech. here's how to close the gap, world econ. f. (june 21, 2018), https://www.weforum.org/agenda/2018/06/law-too-slow-fornew-tech-how-keep-up/ [https://perma.cc/93sf-ssxt]. 2. see id. 3. see ronald leenes et al., regulatory challenges of robotics: some guidelines for addressing legal and ethical issues, 9 l. innovation & tech. 1, 7 (2017). 4. see david britton, automating surgery: the law of autonomous surgical robots, j.l. &tech. texas. (2016). 5. see paul cerrato, medical device security: is your facility at risk?, medpage today, https://www.medpagetoday.com/resource-centers/osteoporosis/medical-device-security-yourfacility-risk/693[https://perma.cc/azg2-tkvq]. 6. see leenes, supra note 3, at 7. 7. id. at 1. 8. see id. 9. see new surgical robots are about to enter the operating theatre, economist (nov. 16, 2017), https://www.economist.com/science-and-technology/2017/11/16/new-surgical-robots-areabout-to-enter-the-operating-theatre [https://perma.cc/r4ny-sg5j]. 368 indiana health law review [vol. 17:367 medical realm becomes less of a dream and more of a reality.10 yet again, reflecting the need for our legal system to create strong regulatory standards for current and future surgical robotics.11 though surgical robotics maintain the potential to expand surgical treatments and medical practices beyond the limits of human ability, while reducing human error, there still remain the worst-case situations.12 situations involving systematic robotic failure, resulting in serious bodily injury or even death and thus creating the legal issue of what parties should be held liable in relation to the systematic failure.13 a clear example of this is demonstrated by laurie featherstone who put all her faith in the doctor and didn’t ask questions when her colon and ureter were damaged during a robotic surgery.14 this article critically examines the concepts, possibilities, problems, and possible legal solutions that will occur when the use of fully autonomous surgical robotics become part of everyday practice within the medical field.15 as fully autonomous surgical robotics become a real possibility, a solution based on historic precedent and statutes must be considered when formulating a future solution to deal with legal issues involving fully autonomous surgical robotics. in order to create such a solution, an explanation and breakdown of the fundamentals and concepts of what robotics are and how they function in the realm of modern medicine is required. secondly, by analyzing the historic foundation of current semi-autonomic robotics’ statutes and case law that is being used in today’s current medical society to better understand what is required in the future. lastly, through an analogy of automotive and aviation, an in-depth analysis of how the current legal system is handling fully autonomous robotics and how to create solutions for both current and future legal issues associated that would best fit the needs for both current and future society. overall, by expanding and analyzing all the information as stated above, a potential foundational solution can be generated to help regulate and handle future legal disputes arising 10. eliza strickland, autonomous robot surgeon bests humans in world first, ieee spectrum (may 4, 2016, 6:17 pm), https://spectrum.ieee.org/the-human-os/robotics/medicalrobots/autonomous-robot-surgeon-bests-human-surgeons-in-world-first [https://perma.cc/ckb3zpxh]. 11. see leenes, supra note 3, at 1, 7. 12. see jeremy russell, the future of medical robotics, it proportal (nov. 24, 2017), https://www.itproportal.com/features/the-future-of-medical-robotics/ [https://perma.cc/w6sfcs99]. 13. see markus christen et al., an evaluation schema for the ethical use of autonomous robotic systems in security applications, 1, 55-56 (2017), https://philarchive. org/archive/chraes-3 [https://perma.cc/5hkl-fhmc]. 14. emily siegel et al., the da vinci surgical robot: a medical breakthrough with risks for patients, nbc news (dec. 19, 2018, 6:29 pm), https://www.nbcnews.com/health/health-news/davinci-surgical-robot-medical-breakthrough-risks-patients-n949341 [https://perma.cc/esw5-m2fs]. 15. see generally how are robots changing healthcare, healthcare admin. degree programs, https://www.healthcare-administration-degree.net/faq/how-are-robots-changinghealthcare/ [https://perma.cc/v8cv-9dcq]. 2020] the legal battle with the future of autonomous surgical robotics 369 out of the usage and failure of fully autonomous surgical robotics. ii. background a. basic concepts of robotics today, robots are generally understood to be machines that are programmed by computers, which allows them to be capable of completing a series of actions automatically. 16 furthermore, these robotics contain additional abilities to process data or physical perceptions electronically, operate, move, operate physical parts of, sense and manipulate their environment, and exhibit intelligent behavior, especially behavior which mimics humans or other animals.17 these abilities allow robotics to be able to participate in common human interactions, such as, “playing chess . . . recognizing faces and driving safely.”18 additionally, robotics in today’s world impact almost every single person’s life in some manner.19 a classic example of this can be seen within the world of telephone communication, “[w]e have gone from simple lan phones to super-smart cell phones that are taking over the realm of the laptop.”20 more specifically, advancements in the realm of robotics have allowed them to become key centerpieces in medical procedures.21 this ability is exemplified by robots containing “characteristic features include the capability to move along multiple axes (directions), programmability, and a closed sensory loop allowing the machine to react to sensory input.”22 these characteristic features have allowed doctors, surgeons, and other medical professionals to perform more precise, quicker, and less intrusive surgeries over the years.23 as stated by dr. bertalan mesko, phd, founder of the medical futurist, the usage of current and future robotics “will help to make healthcare sustainable and much more efficient in the future.”24 according to a study performed in 2004, “[t]oday robots are used to perform highly specific, highly precise, and dangerous tasks in industry and 16. see robot, oxford english dictionary (2d ed. 2017). 17. see tom harris, how robots work, howstuffworks (april 16, 2002), https://science. howstuffworks.com/robot.htm [https://perma.cc/mzg8-xnp6]. 18. george musser, what the rise of sentient robots will mean for human beings, nbc news: mach (june 19, 2017, 1:15 pm), https://www.nbcnews.com/mach/tech/what-rise-sentientrobots-will-mean-human-beings-ncna773146 [https://perma.cc/4khx-s9qu]. 19. see id. 20. see len calderone, advancement of robots in medicine, robotics tomorrow (may 15, 2018, 8:24 am), https://www.roboticstomorrow.com/article/2018/05/advancement-of-robots-inmedicine/11948 [https://perma.cc/up47-79hz]. 21. see russell, supra note 12. 22. expert report and affidavit, fuji am. corp. v. u. s., no. 03-00126, 2003 wl 2510697. 23. see russell, supra note 12. 24. id. 370 indiana health law review [vol. 17:367 research previously not possible with a human workforce.”25 specifically, the stated abilities and features above will be key concepts and notions that will arise from the future capabilities of autonomous surgical robotics.26 b. autonomous robotics in order to understand the importance and issues that occur with autonomous surgical robotics, it is key to understand the basic fundamentals of what autonomous surgical robotics are and how they operate. webster dictionary defines autonomy as “with reference to a thing: the fact or quality of being unrelated to anything else, self-contentedness; independence from external influence or control, self-sufficiency.”27 furthermore, district of colombia legislators have expanded and legally defined autonomy, in terms of vehicles, to be “a vehicle capable of navigating district roadways and interpreting trafficcontrol devices without a driver actively operating any of the vehicle’s control systems.”28 though basic in definition, it still demonstrates both current and futuristic possibilities of autonomous technology can produce not only in the realm of medicine but in society as a whole. as society has progressed, the concepts and abilities surrounding autonomous robotics have too.29 as stated earlier, the main focus of this note is centered around the futuristic possibility of fully autonomous robotics being part of the medical realm. this notion of fully autonomous robotics may seem far-fetched in theory, but it is a very realistic notion.30 researchers have opined: “[m]uch like the robots in popular culture, the future of robotics in surgery is limited only by imagination. many future ‘advancements’ are already being researched.”31 these advancements in technology have already and will continue to change how industries function. as emphasized, advanced robotics not only allow the practice of medical procedures to be safer, the advancement of robotics will allow companies and industries as a whole to become more productive and hopefully create a strong sector in the economy.32a clear example of this advancement can be seen through the withdrawal of blood for blood sample tests. robotics maintain the capabilities to determine which veins are “good veins,” instead of having a medical professional insert numerous needles in order to determine 25. see anthony r. lanfranco, andres e. castelllanos, jay p. desai & william c. meyers, robotic surgery: a current perspective, 239 ann. surgery 14, 18, 19 (2004). 26. see russell, supra note 12. 27. autonomy, oxford english dictionary (2nd ed. 2017). 28. d.c. code §50-2351(1) (2013). 29. see robotics in healthcare -get ready!, med. futurist (2016), https://medicalfuturist. com/robotics-healthcare [https://perma.cc/a2ea-xkat]. 30. id. 31. lanfranco, supra note 25, at 20. 32. scott a. wolla, will robots take our jobs?, econ. res. fed. res, bank st. louis (jan. 2018), https://research.stlouisfed.org/publications/page1-econ/2018/01/02/will-robots-take-our-jobs [https://perma.cc/mml8-g4gx]. 2020] the legal battle with the future of autonomous surgical robotics 371 which vein is best for the procedure.33 additionally, a test between a human doctor and autonomous robotics provides vital insight and demonstrates that this notion of fully autonomous surgical robotics is a realistic possibility as technology and society progress.34 the test was centered and focused on “a bot stitched up a pig’s small intestines using its own vision, tools, and intelligence to carry out the procedure . . . [w]hat’s more, the smart tissue autonomous robot (star) did a better job on the operation than human surgeons who were given the same task.”35 this revolutionary breakthrough portrays a clear indication that the notion of the fully autonomous robotics is not some concept only seen in movies such as “star wars” but rather is a concept that is going to be a key and common foundation within the realm of medical procedures. from determining best veins for blood samples to stitching up intestines, these breakthroughs demonstrate that fully autonomous robotics are coming now. rather, instead of waiting for issues to arise later, it would be best to create a legal solution now in anticipation of future issues. further, a more commonly known medical procedure, telesurgery, provides even more foundational support. telesurgery in its basic understanding can be described as “[a]nother avenue of growth in the field of robotic surgery . . . where the surgeon is not in the same location or even in the vicinity of the patient being operated on.”36 though telesurgery is different from autonomous robotic surgery, the notion that telesurgery is developing is a great indication that the overall concept of autonomous robotics surgery is not as far-fetched as some may believe. the commonly asked question when one is either reading or hearing about said surgical robotics, is how does it work? as stated above, one of the most common ways one of the most common ways the current medical community is through telesurgery. in its most basic form/description, the surgical robot is controlled by “a nearby console, [with which the] surgeon manipulates those instruments to perform the operation.”37 some have considered it to be like playing a real-life video game.38 the “surgeon is in control the whole time; the surgical system responds to the direction he provides.”39 not only through studies are fully autonomous robotics proven to be a realistic notion, but this notion is also supported through the use of partial and fully autonomous robotics in today’s modern vehicles.40 the notion of self33. see how are robots changing healthcare, supra note 15. 34. see strickland, supra note 10. 35. id. 36. jay shah, arpita vyas & dinesh vyas, the history of robotics in surgical specialties, 12 am. j. robotic surgery 11 (2014). 37. about robotic surgery at ucla, ucla health, https://www.uclahealth.org/roboticsurgery/what-is-robotic-surgery [https://perma.cc/jn4s-73fp]. 38. see klint finley, how videogames could help train the next generation of robotic surgeons, wired: sci., https://www.wired.com/2012/12/robotic-surgery-and-gaming/ [https:// perma.cc/tb56-9t7q]. 39. id. 40. see, kersten hineke et al., self-driving car technology: when will the robots hit the 372 indiana health law review [vol. 17:367 driving cars is a clear indicator that the technology for fully autonomous robotics is already out in society and is developing at a rapid rate. pediatric surgeon peter kim expanded on this connection/correlation by stating “‘[n]ow driverless cars are coming into our lives . . . [i]t started with self-parking, then a technology that tells you not to go into the wrong lane. soon you have a car that can drive by itself. similarly, he said, ‘surgical robots could start by giving human surgeons a helping hand. and maybe one day they’ll take over.’”41 as stated above, it can be very clearly concluded that this is not a moot point. the notion of fully autonomous robotics is a point that is one already in our society,42 and a too realistic notion that is coming fast for the realm of medicine.43 the realm of law slow-moving in nature, detail-driven, and results in the common perception that cases generally take too long to enter and make their way through american courts.44 the notion of fully autonomous surgical robotics is a concept that should be addressed before the problems occur as both money and lives are at risk within the realm of medicine and society. iii. usage and development of surgical robotics since the fda approved the use of robotics within medical procedures and surgeries, there has been rapid growth to make said robotics more effective, quicker, and overall a better plan.45 furthermore, since the approval of the da vinci-assisted surgical robot and other similar counterparts, there has been “a total of 1.745 million robotic surgeries . . . between the years 2000–2013 in the usa.”46 this large number alone can reflect how ingrained surgical robotics are in everyday use within the modern realm of medical practices.47 as stated by sanja dogramadzi, a professor in medical robotics at the university of the west road?, mckinsey & company: our insight (may 2017), https://www.mckinsey.com/industries/ automotive-and-assembly/our-insights/self-driving-car-technology-when-will-the-robots-hit-theroad [https://perma.cc/6nzf-9d3f]. 41. strickland, supra note 10. 42. see nabeel hyatt, autonomous driving is here, and it’s going to change everything, recode (apr. 19, 2017, 7:30 pm), https://www.recode.net/2017/4/19/15364608/autonomous-selfdriving-cars-impact-disruption-society-mobility [https://perma.cc/ejx5-sc49]. 43. see harold stark, prepare yourselves, robots will soon replace doctors in healthcare, forbes (jul. 10, 2017 1:00 pm), https://www.forbes.com/sites/haroldstark/2017/07/10/prepareyourselves-robots-will-soon-replace-doctors-in-healthcare/ [https://perma.cc/p3jz-ensl]. 44. mary lee luskin & robert c. luskin, why so fast, why so slow: explaining case processing time, 77 j. crim. l, & criminology 190, 190 (1986). 45. see generally alessia ferrarese, et al., malfunctions of robotic system in surgery: role and responsibility of surgeon in legal point of view, 11 open med. 286, 286 (2016). 46. fatih hitami usluoðullarý, sýtký tiplamaz, & nesime yayci, robotic surgery and malpractice, 43 turkish j. urology 425, 425 (2017). 47. see jo best, robots and the nhs: how automation will change surgery and patient care, zd net (nov. 19, 2018), https://www.zdnet.com/article/robots-and-the-nhs-how-automationwill-change-surgery-and-patient-care/ [https://perma.cc/x3zt-z5mk]. 2020] the legal battle with the future of autonomous surgical robotics 373 of england's bristol robotics laboratory, “in the years to come we will see subsystems gaining more autonomy in order to allow the surgeon to do things faster, better, and more precisely."48 at this very moment, there are considered to be eleven “big brands”: da vinci, sensei x robotic, corpath 200, vdrive robotic, rosa brain, rosa spine, senhance, titan sport robot-assisted surgery platform, mako rio robot, smith & nephew’s navio surgical system, medrobotics’ flex robotic system, and mazor robotics renaissance guidance system.49 just as in the automotive industry, each brand has its own ‘signature mark,’ “special features,” and skills for specific tasks or objectives than its competitors.50 the da vinci robots were used in over “600,000 surgeries in 2016 and the system is capable of aiding surgeons with everything from hysterectomies to prostatectomies. however, just like humans, robots are not perfect. even surgical robotics have failed and continue to do so.51 these failures have been proven to be caused by two factors, one being the surgeons’ inability to use the device properly, and two being device dysfunction.52 device dysfunction varies and is dependent on what brand’s device is used and what surgical performance is being rendered by the device.53 a specific example can be seen within the sensei x robotic, which became “loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. the cardiac tamponade, delayed procedure, or crush [can cause] injury to the patient and/or user.”54 in order to determine how frequently these errors occur, a study was performed from 20042015 that produced a result that showed that of the “386 malfunctions were described out of 14141 procedures, 20.9% of which was damage caused by malfunction of the [robotic surgery]rs arms and instruments.”55 an additional study from 2003 to 2013 produced the results that 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%).56 furthermore, by 2015 there have already been “144 deaths and more than 1,000 48. id. 49. fink densford, 11 surgical robotics companies you need to know, mass device (feb. 1, 2017), https://www.massdevice.com/11-surgical-robotics-companies-you-need-to-know/ [https:// perma.cc/f2r3-j6vy]. 50. see mathias hoeckelmann et al., current capabilities and development potential in surgical robotics, 12 int’l j. advanced robotic sys. (jan. 1, 2015). 51. see homa alemzadeh et al., adverse events in robotic surgery: a retrospective study of 14 years of fda data, 11 plos one 4 (2016). 52. ferrarese, supra note 45, at 286. 53. id. at 288. 54. michelle bayefsky & benjamin e. berkman, fda’s proposed guidance for laboratory developed tests: how should regulators balance the risks and promise of innovation in clinical genetics?, 5 fdli’s food & drug pol’y f. (2015). 55. ferrarese, supra note 45, at 287. 56. alemzadeh, supra note 51, at 4. 374 indiana health law review [vol. 17:367 injuries” linked directly to the usage of surgical robotics.57 though on the face, these numbers seem large and extreme, they are smaller compared to the deaths and injuries that occur worldwide due to the human error rates within surgical procedures.58 thus, it makes the application of surgical robotics more appealing as the technology advances and error rates drop.59 as many professionals have confirmed and/or stated, “the lurking fear of legal action and even just the desirable reassurance of having an expert on hand for those awful ‘what-ifs.’”60 as stated above and continuing below, those “what-ifs” can turn into messy, long, and costly litigation if no proper case law or statute is presented in order to help the court system be guided through the challenges of disputes of technology. iv. society usage of automatic robotics the usage and notion of autonomous robotics have been historically related to the automotive industry,61 and less frequently thought the aviation industry. as stated earlier, this note is focusing its argument through an analogy of how states and the nation as a whole have handled other industries in relation to their usage of automatic robotics. congress stated in 2016, that self-driving vehicles reduce the notion of crashes produced by alcohol consumption and driving, and over human error.62 furthermore, the use of said automated technology has reduced the dependency/need for skilled pilots, with high rated capabilities.63again, stressing the overarching issue of increasing societal safety, the implementation of autonomous robotics. automatic robotics within the automotive industries are commonly known as self-driving cars.64 the strong societal push for the use of autonomous robotic vehicles is due to the notion of human error and it’s relation to crashes and other similar issues of human driving-related injuries.65 these issues can be proven by 57. robotic surgery linked to 144 deaths in the us, bbc news (july 22, 2015), https://www.bbc.com/news/technology-33609495 [https://perma.cc/kw76-mq2m]. 58. id. 59. see id. 60. mark piesing, medical robotics: would you trust a robot with a scalpel?, guardian (oct. 10, 2014, 4:00 pm), https://www.theguardian.com/technology/2014/oct/10/medical-robotssurgery-trust-future [https://perma.cc/ma8g-kl3h]. 61. see wired brand lab for ford motor company, a brief history of autonomous vehicle technology, wired, https://www.wired.com/brandlab/2016/03/a-brief-history-of-autonomousvehicle-technology/ [https://perma.cc/4ydy-vvwv] . 62. hands off: the future of self-driving cars: hearing before the s. comm. on commerce, sci,, and transp., 114th cong. (2016). 63. id. 64. see david benady, self-driving cars to hospital robots: automation will change life and work, guardian (mar. 30, 2016), https://www.theguardian.com/sustainable-business/2016/ mar/30/robot-economy-workforce-artificial-intelligence [https://perma.cc/77th-kqs3]. 65. see u.s. dep’t of transp. & nat’l highway traffic safety admin., automated driving systems 2.0, a vision for safety 2 (2017), https://www.nhtsa.gov/sites/nhtsa. 2020] the legal battle with the future of autonomous surgical robotics 375 “[t]he major factor in 94 percent of all fatal crashes is human error . . . adss [automatic driving systems] have the potential to significantly reduce highway fatalities by addressing the root cause of these tragic crashes.”66 one of the most vivid examples that come to one’s mind is google’s self-driving car.67 this classic example is completely automatic due to the car having complete control over the gas, brake, and steering systems.68 additionally, uber and telsa maintain their own line of self-driving automotive vehicles.69 uber’s autonomous vehicle is officially known as “otto”, which is equipped with radar, cameras, lidar, and other automated technology.70 this would allow a truck driver to sleep while the truck is driving itself.71 as for telsa, their autonomous automotive line consists of models x and s, which contain “hardware—cameras, ultrasonic sensors, and an onboard supercomputer—for self-driving”, and additionally contains a chip known as nvidia that gives the car “eyes” to analyze and interpret its surroundings in order to make the logically correct driving decisions.72 though these examples are similar in nature, the difference that makes each brand of vehicle autonomous is a factor that lawmakers and the court systems may and must take into consideration when trying to determine the appropriate action. this can be directly related back to the eleven big brands that are maintained and produced within the medical realm. this may end up being a key factor and influencer when creating future laws and statutes centering fully autonomous surgical robotics.73 meaning, if the national government and or states implement laws that handle each brand of autonomous vehicle differently, one could predict a very similar implementation of laws towards the brands that control the autonomous surgical robotic industry. though fully autonomous surgical robotics may not be on the market for the medical realm, the technology for such robotics is currently being used within society as we speak. thus, making autonomous surgical robotics a very real notion that should gain the respect of the legal system. lawmakers will be faced with these issues surrounding the advanced surgical robotics within our near future. dot.gov/files/documents/13069a-ads2.0_090617_v9a_tag.pdf [https://perma.cc/2yut-qynj]. 66. id. 67. see samuel gibbs, google's self-driving car: how does it work and when can we drive one?, guardian (may 29, 2014), https://www.theguardian.com/technology/2014/may/28/googleself-driving-car-how-does-it-work [https://perma.cc/8ala-x65h]. 68. id. 69. john markoff, want to buy a self-driving car? big-rig trucks may come first, n.y. times (may 17, 2016), https://www.nytimes.com/2016/05/17/technology/want-to-buy-a-selfdriving-car-trucks-may-come-first.html [https://perma.cc/v59f-u978]. 70. see id. 71. id. 72. see jack stewart, tesla says its new self-driving chip is finally baked, wired (aug. 4, 2018), https://www.wired.com/story/tesla-self-driving-car-computer-chip-nvidia/ [https://perma. cc/2anl-xn6z]. 73. see generally densford, supra note 49. 376 indiana health law review [vol. 17:367 v. statues and regulations a. automotive statues and regulations 1. federal statutes and regulations as examined above, the rapid development of autonomous robotics within both the automotive and aviation industries have produced and contributed great benefits in today’s society. however, though these technological advancements have produced benefits, there are still issues on how to regulate said technology and how to handle cases within a court of law when an autonomous robotics system fails.74 states and the nation as a whole are struggling to define notions and concepts such as, “vehicle operator,” “autonomous driving system,” and whether or not the vehicle must contain safe features consisting of “human operator.” all of which are terms and concepts that would be key in any legal dispute, settlement, or statute moving forward. below are a discussion and indepth analysis of a major national and state regulatory standard that was developed to determine key features to help regulate autonomous surgical robotics in the future. both on a federal and state level, lawmakers have taken action to pass legislation in order to classify and regulate autonomous vehicles that may enter the public streets.75 the best illustration of how states have handled the development of autonomous robotics is seen within michigan and colorado legislation.76 in addition to federal bills and states’ bills, the u.s. department of transportation (dot), through the national highway traffic safety administration (nhtsa), is taking a large stronghold in regulating autonomous robotic vehicles.77 specifically, the nhtsa has created “[t]he voluntary guidance contain[ing] 12 priority safety design elements.”78 within each element, there are clear recommendations and guidelines that all autonomous vehicles should maintain or have the ability to perform. however, as the title of the guide states, these are voluntary elements and not required by law. though they are not forced to follow the guidance elements for autonomous vehicles, the principle of each element could be something that could be used when developing the possible solution for fully autonomous surgical robotics. through studies and 74. see darrell m. west & john r. allen, how artificial intelligence is transforming the world, brookings (apr. 24, 2018), https://www.brookings.edu/research/how-artificialintelligence-is-transforming-the-world/ [https://perma.cc/bd49-2gzq]. 75. see autonomous vehicles | self-driving vehicles enacted legislation, nat’l conf. state legislatures (oct. 9, 2019), http://www.ncsl.org/research/transportation/autonomousvehicles-self-driving-vehicles-enacted-legislation.aspx [https://perma.cc/59c3-he39]. 76. id. 77. see generally u.s. dep’t of transp. & nat’l highway traffic safety admin., supra note 65. 78. id. at 1. 2020] the legal battle with the future of autonomous surgical robotics 377 research, the 12-element safety design is meant to help, support, and “reach[]an era of crash-free roadways through the deployment of innovative lifesaving technologies.”79 “element 1: system safety,”80 focuses on encouraging entities to “follow a robust design and validation process based on a systems-engineering approach with the goal of designing adss free of unreasonable safety risks. the overall process should adopt . . .the functional safety process standard for road vehicles, and collectively cover the entire operational design domain . . . of the system.”81 “element 2: operational design domain,”82 focuses on the capabilities of the vehicle on roadway types (interstate, local, etc.), geographic area (city, mountain, desert, etc.), safety operation features, speed range, and environmental conditions in which the ads will operate (weather, daytime/nighttime, etc.).83 “element 3: object and event detection and response,”84 analyzes the capabilities and functions of “the ability to address a wide variety of foreseeable encounters, including emergency vehicles, temporary work zones, and other unusual conditions (e.g., police manually directing traffic or other first responders or construction workers controlling traffic) that may impact the safe operation of an ads.”85 “element 4: fallback (minimal risk condition),”86 creates a foundation for basic requirements in case of robotic failures. “[e]ntities are encouraged to have a documented process for transitioning to a minimal risk condition” when the robotic systems fail and there need for human driver intervention.87 “element 5: validation methods,”88 is an element the promotes for feature research in order to develop the best and safest autonomous robotic technology for market use. manufacturers should continue to develop tests and “entities are encouraged to develop validation methods to appropriately mitigate the safety risks associated with their ads approach.”89 “element 6: human machine interface,”90 entities are encouraged to broadcast, develop and explain how the human and machine relationship works within the systematic use of the vehicle and should make: considerations should be made for the human driver, operator, 79. id. 80. id. at 5. 81. id. 82. id. at 6. 83. id. 84. id. at 7. 85. id. 86. id. at 8. 87. id. 88. id. at 9 89. id. 90. id. at 10. 378 indiana health law review [vol. 17:367 occupant(s), and external actors with whom the ads may have interactions, including other vehicles (both traditional and those with adss), motorcyclists, bicyclists, and pedestrians. hmi design should also consider the need to communicate information regarding the ads’s state of operation relevant to the various interactions it may encounter and how this information should be communicated.91 furthermore, unlike the rest of the elements where the nhtsa encourages or promotes the bare minimum standards, in order to fulfill the standard behind element 6: human machine interface, “[a]n ads should be capable of informing the human operator or occupant through various indicators that the ads are: [f]unctioning properly, [e]xperiencing a malfunction, and/or [c]urrently engaged in ads mode, [r]equesting control transition from the ads to the operator, and [c]urrently “unavailable” for use.”92 thus, making element 6 a key element to consider when lawmakers are creating a future solution in relation to autonomous surgical robotics. “element 7: vehicle cybersecurity,”93 reflects an overarching industry standard that should be engrained into all industries that use or develop autonomous robotic technology. entities are encouraged to follow a robust product development process based on a system engineering approach to minimize risks to safety, including those due to cybersecurity threats and vulnerabilities. “element 8: crashworthiness,”94 breaks down into two sub-elemental categories. one being occupant protection and the second being compatibility. occupant protection encourages entities to “consider incorporating information from the advanced sensing technologies needed for ads operation into new occupant protection systems that provide enhanced protection to occupants of all ages and sizes.”95 while compatibility encourages and/or suggests that “adss intended for product or service delivery or other unoccupied use scenarios should consider appropriate vehicle crash compatibility given the potential for interactions with vulnerable road users and other vehicle types.”96 “element 9: post-crash ads behavior,”97nhsta encourages entities to both to engage in “testing or deployment should consider methods of returning adss to a safe state immediately after being involved in a crash” and develop “communications with an operations center, collision notification center, or vehicle communications technology exist, relevant data is encouraged to be communicated and shared to help reduce the harm resulting from the crash.”98 91. id. 92. id. 93. id. at 11. 94. id. at 12. 95. id. 96. id. 97. id. at 13. 98. id. 2020] the legal battle with the future of autonomous surgical robotics 379 “element 10: data recording,”99 may be one of the most important elements for future development of all autonomous robotics usage. the nhsta encourages entities to learn from crash data in order to develop safer methods, by gathering data from “on-road testing and use, and entities are encouraged to adopt voluntary guidance, best practices, design principles, and standards issued by accredited standards developing organizations such as sae international.”100 “element 11: consumer education and training,”101 nhtsa stresses that it is imperative for increased safety during the development process and the usage of ads robotic systems. therefore: entities are encouraged to develop, document, and maintain all information and give to any employee, dealer, distributor, and consumer about all education and training programs to address the anticipated differences in the use and operation of ads from those of the conventional vehicles that the public owns and operates today.102 such programs, should be aimed to teach operators and distributors the proper manners and/or standards to maintain, in order to avoid any possible legal ramification from either parties or patents during later usage.103 “element 12: federal, state, and local laws,”104 as mentioned below, state laws and federal laws have different ways of defining, interrupting, and handling issues of legal problems associated with ads robotic systems. as such: entities are also encouraged to document how they intend to account for all applicable federal, state, and local laws in the design of their vehicles and adss. based on the operational design domain(s), the development of adss should account for all governing traffic laws when operating in an automated mode for the region of operation.105 in 2016, the society of auto engineers international published guidelines and a chart for autonomous vehicle classification known as sae j3016.106 the sae j3016 guidelines allow for easier classification of autonomous vehicles into six different levels of autonomous ability.107 through formal acknowledgment, the central focus of the sae j3016 is to create “a clearer and in some ways simpler framework for an ongoing conversation between industry stakeholders, 99. id. at 14. 100. id. 101. id. at 15. 102. id. 103. see id. 104. id. at 15 105. id. 106. jennifer shuttleworth, sae standards news: j3016 automated-driving graphic update, sae int’l: sae j3016: level of driving automation (jan. 7, 2019), https://www.sae. org/news/2019/01/sae-updates-j3016-automated-driving-graphic [https://perma.cc/znv4-eu62]. 107. see id. 380 indiana health law review [vol. 17:367 advocates, and state and local governments that can help direct ongoing regulatory efforts as the industry continues to progress."108 the sae j3016 breaks down each level by how autonomous the vehicle is.109additionally, the higher the level one’s vehicle is classified as, the more regulation, tests, controls, and protective features the vehicle must maintain and possess.110 level zero: no automation, contains “[t]he full-time performance by the human driver of all aspects of the dynamic driving task, even when enhanced by warning or intervention systems,” and is fully operated by a human driver.111 typically, a level zero is your everyday car with just enhanced features such as review cameras, side mirrors cameras and etc.112 level one: driver assistance,113 contains “the driving mode-specific execution by a driver assistance system of either steering or acceleration/deceleration and using information about the driving environment and with the expectation that the human driver perform all remaining aspects of the dynamic driving task.”114 level one classified vehicles are operated predominantly by human drivers, but as stated above, maintain features are governed my autonomous robotics.115 level two: partial automation,116 contains the same features as level one classified vehicles, but shifts further towards complete automation, and containing more features of robotic function.117 a modern-day example of level one and two classified vehicles would be the 2014 jeep cherokee, which maintains a self-parking robotics system.118 the selfparking features are just an individual autonomous feature that allows the robotics system to park while maintaining the rest of the vehicle operational by a human driver.119 members of the society of auto engineers international made a clear 108. u.s. dot chooses sae j3016 for vehicle-autonomy policy guidance, soc’y of auto. engineers int’l (sept . 20, 2016, 5:39 am), http://articles.sae.org/15021/ [https://perma.cc/sl8dhzyq] (quoting statement from jeremy carlson, principal automotive analyst, ihs markit). 109. see id. 110. id. 111. soc’y of auto. engineers int’l, automated driving: levels of driving automation are defined in new sae international standard j3016, https://templatelab. com/automated-driving/ [https://perma.cc/3tx4-6g7f]. 112. id. 113. id. 114. id. 115. id. 116. id. 117. id. 118. jonathan elfalan, 2014 jeep cherokee limited long-term road test, edmunds (mar. 2, 2020), https://www.edmunds.com/jeep/cherokee/2014/long-term-road-test/2014-jeep-cherokeelimited-park-like-a-jerk-assist.html [https://perma.cc/9gzd-2ndj]. 119. ed grabianowski, how self-parking cars work, howstuffworks, https://auto. howstuffworks.com/car-driving-safety/safety-regulatory-devices/self-parking-car.htm [https://perma.cc/qca9-nycj]. 2020] the legal battle with the future of autonomous surgical robotics 381 break between levels 0,1,2 and 3,4,5. this is reflected in the clear language division, separating non-autonomous vehicles from autonomous.120 this separation created and will continue to create different types of regulations, procedures, and tests that will need to be met and passed in order to be allowed to hit the streets of today’s world. the next tier of classification maintains the same overarching regulations and status of containing “[t]he driving modespecific performance by an automated driving system of all aspects of the dynamic driving task.”121 level three: conditional automation,122 is an automatize vehicle “with the expectation that the human driver will respond appropriately to a request to intervene.”123 level four: high automation,124 contains that robotic system features that will intervene even if the human driver does not appropriately request said intervention when the vehicles believe that intervention is appropriate.125 level five: full automation,126 lastly contains that robotic system features that control every aspect of the vehicle “under all roadway and environmental conditions that can be managed by a human driver.”127 both the society of auto engineers international’s guidelines to help regulate and charts determining levels of automation are key aspects of regulating autonomous vehicles that could be easily translated and or used when creating regulations for fully autonomous surgical robotics.128 not only could some language be used in both, the overall structure of breaking down autonomous surgical robotics into different levels of automation and creating elemental standards as the u.s. department of transportation and national highway traffic safety administration did, it would also be beneficial to autonomous surgical robotics.129 both aspects of structure and language usage will be addressed in more depth later in the note. however, its key to note that it is imperative for lawmakers to thoroughly look through past bills and guidelines as the ones examined above in order to determine what aspects and notions would and would not work when creating future bills of standards and regulations for fully autonomous robotics in the near future. 120. see soc. of auto. engineers int’l, supra note 111. 121. see yamauchi mia, why we need a meaningful comparison of vehicle autonomy, plugless, https://www.pluglesspower.com/learn/need-meaningful-comparison-vehicle-autonomy/ [https://perma.cc/ba4n-eg4g]. 122. see soc. of auto. engineers int’l, supra note 111. 123. id. 124. id. 125. see id. 126. id. 127. id. 128. id. 129. id. 382 indiana health law review [vol. 17:367 2. state statutes and regulation as seen above, the purpose of the national standards is to help classify more readily how autonomous a vehicle is and how much regulation it should receive.130 unlike the nationwide standards, each state bill is a more thorough breakdown of each component of what it means to be a full, partial, or semiautonomous operated vehicle.131 this notion of a thorough breakdown is reflexed by language seen within the bills of michigan and colorado. each bill contains specific aspects that will help lay down a key foundation in order to create a potential solution that would help regulate the futuristic problem of fully autonomous surgical robotics.132 in 2013, michigan passed legislation that focused in on how to control and determine damages, specifically product liability damages, that are caused by autonomous driving vehicles.133 the main driving force behind the bill is to allow technology to grow at a rapid rate in order to keep up with social needs.134 however, the legislation is not without any regulations. it requires all autonomous vehicles to adhere to all safety requirements related to autonomous vehicle testing.135 in 2017, colorado passed a bill that focused mainly on test procedures and regulations on autonomous vehicles before they are even allowed to be used in society. the overarching concept of the bill is that any automated driving system vehicles that are not yet capable of complying with all state and federal laws cannot be tested unless approved by the colorado state patrol in the department of public safety (dps) and the colorado department of transportation (cdot).136 what makes the colorado bill different from other regulatory bills is the language pertaining to the dual regulation of complying with all state and federal laws. this reflects a harsh standard on all autonomous vehicles and ensures greater levels of safety. this concept of dual complication is a concept that the legal field should consider and apply when creating bills and regulations 130. see pratt stephanie & boafo kwame, semi-autonomous motor vehicles: what are the implications for work-related road safety, cts. for disease control and prevention: niosh sci. blog, (april 22, 2014) https://blogs.cdc.gov/niosh-science-blog/2014/04/22/semi-autonomousvehicles/ [https://perma.cc/7sta-zm5a]. 131. see roy alex, the language of self-driving cars is dangeroushere’s how to fix it, the drive (may 9, 2018), https://www.thedrive.com/tech/20553/the-language-of-self-drivingcars-is-dangerous-heres-how-to-fix-it [https://perma.cc/dlp2-4zl3]. 132. jack karsten, darrell west & christian r. lansang, the state of self-driving car laws across the u.s., brookings: techtank, https://www.brookings.edu/blog/techtank/2018/05/01/ the-state-of-self-driving-car-laws-across-the-u-s/ [https://perma.cc/v399-djk3]. 133. 2013 mich. pub. acts 231. 134. 2013 mich. pub. acts 231. 135. autonomous vehicles: self-driving vehicles enacted legislation, nat’l conf. state legis. (oct. 2018), http://www.ncsl.org/research/transportation/autonomous-vehicles-self-drivingvehicles-enacted-legislation.aspx [https://perma.cc/59c3-he39]. 136. 2017 colo. sess. laws sb17-213. 2020] the legal battle with the future of autonomous surgical robotics 383 centered around autonomous robotics. in addition to creating standards and regulations, the colorado bill also addresses the concept of workload and revenue. the colorado bill states that the application and use of automatic robotic systems will result in the potential reduction of traffic infractions by human error.137 by clearly stating the required measures to ensure these vehicles meet all legal and safety standards allows the court system to readily assert fines and other proper punishments when said standards are not.138 lastly, the bill states that it is imperative that all local and state agencies apply this standard in a universal manner so that there is no confusion on what the standards and regulations are when the usage of autonomous vehicles occur.139 both michigan’s 2013 mich. pub. acts 231 and colorado’s g.a. res., sb17213 contain key aspects and differences with their standards and regulations on how to control the notion of automation within the realm of self-driving cars. as time continues to move forward, it will be very important to continue to look at state laws and determine, from an objective standard, which aspects of their own laws are working, and which are not. in order to get the best and most useful nationwide regulatory bill for self-driving, but more importantly fully autonomous surgical robotics, it imperative to keep track and note what aspects of each state bill work and which aspects do not work. if lawmakers continue to watch this with a careful eye, there should be no reason not to have a key, uniform and functional bill in place in order to handle most issues that could arise out of usage and failures that occur with the application of fully autonomous surgical robotics within our given society. b. aviation statues and regulations similar to the automotive industry, the formulation of relevant statutes and regulations that are used to maintain proper usage of robotic systems occurred within the aviation industry.140 specifically, the most popular usage of autonomous robotics in the realm of aviation is associated with the concepts of automatic landing and takeoff.141 the usage of automatic landing and takeoffs can be directly correlated to efforts of minimizing “the risks and increas[ing] repeatability of a flight at the same time as reducing the dependence on a human pilot; as the capabilities of the autopilot are improved the need for a skilled pilot is reduced.”142 even though the usage of auto land and takeoff helps reduce error and dependence, lawmakers have placed regulations on how often one can use it. 137. id. 138. see id. 139. id. 140. magnus vestergren, automatic takeoff and landing of unmanned fixed wing aircrafts: a systems engineering approach 1 (2016) https://liu.diva-portal.org/smash/get/ diva2:1055556/fulltext01.pdf [https://perma.cc/wa6k-fk8h]. 141. id. 142. id. 384 indiana health law review [vol. 17:367 the most vided example is statute 14 cfr §61.57. the cfr statue is a federal statute that all commercial air pilots must follow and abide by.143 cfr 14 §61.57 states and/or implies that a pilot in command is required to at least perform three manual and takeoffs and three lands within 90 days.144 the importance of a statute like 14 cfr §61.57 is the need for a “human safe net” when and/or if robotics system failure occurs. 145 the safeguard of human ability/function of pilots to perform without the assistance of robotic systems helps to maintain the highestlevel safety possible. the key significance that can be used from the statutes and regulations above, is requiring doctors to perform a specific amount of surgeries without completely being dependent on the fully or semi-autonomous robotics. the rationale behind such a requirement would be in case of those “worst case situations” happening. worst case being, where the autonomous surgical robotics cannot be used, due to power outage or any other reason, and the doctor would be able to perform the required surgery. overall, by examining the statutes and regulations around the usage of the autonomous technology within the automotive and aviation industries, similar language and policies can and should be used to formulate regulatory standards for the future development of fully autonomous robotics.146 using statutes and regulations from one industry in another has historically been done and has shown strong and positive results in many different fields of law.147 meaning, there is importance behind studying and analyzing past bills and statutes in order to learn what works and what does not work when creating future bills and regulations. this way the same mistake does not occur twice, and great policies can be built upon in order to create a stronger formulated bill for future legal disputes and issues. vi. case law just as important as statutes, both state and federal court case law is another key determinate on how society has already handled past issues involving surgical semi-autonomous robotics and how our court system should continue to use past precedent in the future. as janet fleetwood concluded for her study, the 143. 14 cfr § 61.57 (2018). 144. id. 145. see jason knight, flying artificial intelligence unmanned aerials systems in the united states (2014), https://www.researchgate.net/publication/312042845_flying_ artificial_intelligence_unmanned_aerials_systems_in_the_united_s tates [https://perma.cc/jhp7-hxpr]. 146. see chris middleton, us scraps driverless car regulations, redefines concept of ‘driver’, internet bus.: analysis (oct. 5, 2018), https://internetofbusiness.com/us-scraps-driverless-carregulations-redefines-concept-of-driver/ [https://perma.cc/qk5q-34mu]. 147. see tali l. katz, retrospective v. prospective amendments: when does new federal legislation impact my case?, a.b.a. (mar. 28, 2018), https://www.americanbar.org/groups/ litigation/committees/products-liability/practice/2018/retrospective-vs-prospective-amendmentswhen-does-new-federal-legislation-impact-my-case/ [https://perma.cc/y4sq-2glw]. 2020] the legal battle with the future of autonomous surgical robotics 385 usage of autonomous robotics with the automotive industry has the potential to save nearly 29,000 lives per year in the united states.148 however, there are still issues and problems involving the usage of autonomous vehicles. one of the most common issues that courts have struggled to determine is who should be sued when the robotic system fails. as ian bogost examined in his article, is there even a legal possibility to sue a robot if a failure occurred and if not, who should be held liable?149 just as we see this issue of who to sue with autonomous vehicle failures, the same issue remains true within autonomous surgical robotics.150 when such system failure occurs, injured parties look for responsibility to be taken, compensation to be given and justice to be served.151 thus, the bigger question of how to handle what party should take responsibility for such failures occur within autonomous surgical robotics: the hospital, the surgeon, the manufacturer, or someone more individually associated with the development of the surgical robotic system.152 the issue of surgical robotic failures is an issue that is impacted by numerous fields of law, such as, medical malpractice, manufacture defect, design defect, and project liability.153 each area of law stated above contains specific factors that make each one complex in their individualized way. a clear example of how the court system has historically handled issues of surgical robotic failures is in mracek v. bryn mawr hosp., 363 fed. appx. 925 (3d cir. 2010).154 in sum, a patient sued following a surgery that resulted in alleged damages stemming from the usage of a semi-autonomous surgical robot.155 the doctors performed the surgery on a man with the hospital’s “da vinci robot” which malfunctioned and performed an improper surgery.156 the plaintiff additionally also sued the manufacturer for providing a malfunctioning device that could not perform the surgery with the precision he needed.157 the issue and matter of concern was whether the manufacturer’s liability after 148. janet fleetwood, public health, ethics, and autonomous vehicles, 107 am. j. public health 532-37 (2017). 149. see ian bogost, can you sue a robocar?, the atlantic (mar. 20, 2018), https://www. th ea t lan t ic . com/technology/a rch ive /2 0 1 8 /0 3 /can -you -su e-a -robocar /5 5 6 0 0 7 / [https://perma.cc/b4dx-fldx]. 150. see david s. kemp, autonomous cars and surgical robots: a discussion on ethical and legal responsibility, verdict (nov. 19, 2012), https://verdict.justia.com/2012/11/19/autonomouscars-and-surgical-robots [https://perma.cc/k5ys-eecg]. 151. see david h. sohn, negligence, genuine error, and litigation, 6 int. j. gen. med. 49-56 (2013). 152. see id. 153. taelonnda sewell, robotic surgery lawsuits, legal match (2018), https://www. legalmatch.com/law-library/article/robotic-surgery-lawsuits.html, [https://perma.cc/hg3b-b22r]. 154. mracek v. bryn mawr hosp., 363 fed. appx. 925 (3d cir. 2010) (order granting summary judgment). 155. id. 156. id. 157. id. 386 indiana health law review [vol. 17:367 voluntary dismissal of the hospital.158 the court focused on the notion/legal concept of secondary cause.159 conclusively, the court held that patient presented no evidence to show that erectile dysfunction and groin pain were caused by robot malfunction160 and focused the rule of law that a patient bringing claims must additionally provide evidence that it was, in fact, the robot that caused the pain, injury, or serve discomfort.161 the major take away and rule of law from a case as such signifies that bad surgical outcomes can occur due to not using the readily available surgical robotics to perform the surgery. this demonstrates that the usage of surgical robotics can in fact reduce surgical mishaps and errors.162 as robots become better at precision or dangerous work than humans, we are likely to see more cases in which plaintiffs blame humans for not using robots.163 additionally, the concept of strict liability has come into play for plaintiffs attempting to receive compensation and justice from alleged robotic failures. meaning, that a plaintiff asserting a strict liability claim against a robot manufacturer must plead and prove, under a typical state’s law, that the defendant sold a product that was defective and unreasonably dangerous at the time it left the defendant’s hands, the product reached the plaintiff without substantial change, and the defect was the proximate cause of plaintiff’s injuries. 164 additionally, the washington supreme court laid down key foundational law for the realm of autonomous surgical robotics.165 the washington court system focused on the notion of what should happen in the specific aspects of product liability and tort defense.166 in taylor v. intuitive surgical, inc, the court noted that washington’s product liability law requires both the manufacture and hospital to be aware of and express the dangers of operations conducted by surgical robotics. it is the legal reasonability of the manufacturer to inform the hospital of any defects in the product, however, the hospital has an independent duty of care to their patients.167 here, the taylor case creates a clear chain of responsibility. it should be noted that even though states maintain the right to develop their own state law, it is not uncommon for other states to use different state precedent to, at least at a minimum, influence and potentially guide similar disputes that arise within their own legal system. furthermore, in terms of tort 158. stephen s. wu, summary of selected robotics liability cases 3 (2010), http://ftp.documation.com/references/aba10a/pdfs/2_5.pdf [https://perma.cc/y3gd-nysz]. 159. mracek v. bryn mawr hosp., no. 09-2042, 2010 u.s. app. lexis 2015 (3d cir. jan. 28, 2010). 160. see id. 161. see id. 162. see tara kirkpatrick & chad lagrange, robotic surgery: risks vs. rewards, patient safety network (2016), https://psnet.ahrq.gov/webmm/case/368/robotic-surgery-risks-vsrewards[https://perma.cc/6nwr-858a]. 163. wu, supra note 158. 164. see id. 165. taylor v. intuitive surgical, inc., 187 wash. 2d 743 (2017). 166. id. 167. id. 2020] the legal battle with the future of autonomous surgical robotics 387 defense, the washington supreme court accepted the defense of comparative fault, to apply in the situation of robotic failure in surgeries.168 the major take away from washington’s case law is the creation of key protections for the hospitals when robotic failures occur. this foundation law spreads the notion of liability between all parties involved. i.e. the patient who got hurt, the hospital and doctor who performed the surgery and the manufacturer who created the robotic device. overall, legal disputes involving robotic failure will continue to occur in the realms of medicine, automotive, and aviation. as such, it is important to keep and note major holdings that are handed down, not only by the federal court systems but the state level as well. due to the rapid rate of advancement of robotics and the impact robotic failure maintains upon the legal system as a whole, it is vitally important for legal scholars and makers to keep up to date with all advancements.169 thus, both federal and state legal systems will be analyzing and using other precedents in order to handle any future disputes or litigation that will occur in the future while continuing to rely on experts in the field of robotics.170 vii. recommendation for course of action it is gradually becoming more conceivable that complete autonomous robotics, specifically surgical ones, will change not only the world of medicine but also the world of law and the profession of lawyers in the near future. as such, both legal and statutory provisions should be discussed and developed at the same rate as surgical technology progresses. as examined above, both our legal and law-making bodies have already begun to address the overall concept of autonomous robotics that already exists. by using preexisting statutory and case law, the remainder of this note will address and highlight a possible legal/statutory foundation to handle the futuristic notion of complete autonomous surgical robotics. the principal piece of insight and/or guidance that will be addressed is the united states department of transportation & national highway traffic safety administration twelve elements of autonomous robotic vehicles, with the addition of both federal and state statutory and case law. while, maintaining the twelve structural components, the possible course of action will be to adjust historic statutory and case law to focus on surgical robotics rather than vehicles; this should provide a clear foundation for further and future statutes and case law precedent. the notion of universal standards is one more major importance. meaning that with the application and implementation of universal standards, it reduces companies’ and hospitals’ ability to get out of lawsuits by finding 168. id. 169. see hallie siegel, american law needs a reboot when it comes to robots, medium (mar. 5, 2016), https://medium.com/silicon-valley-robotics/american-law-needs-a-reboot-when-it-comesto-robots-7582dc1224c1 [https://perma.cc/u3nl-xvke]. 170. see id. 388 indiana health law review [vol. 17:367 loopholes within their given state’s regulations and standards. additionally, as we have seen through the history of our court system, applying historic precedent makes handling all later suits simpler in nature, as each case will be applying the same rules and regulations. a. basic classification in a similar manner as the sae j3016 document lays out a six-tier classification system used to readily determine how autonomous a self-driving vehicle is, the same should be done for automated surgical robotics.171 creating and developing a similar classification system for the level of autonomy for surgical robotics should be the first step in developing a possible course of action to handle the legal and statutory problems that may/will occur with usage. as examined above, each tier level of the sae j3016 is determined by how autonomous the robotics system is.172 level 0 equaling completely human operational, to level 5 equaling completely autonomous.173 each level would determine how much regulation and testing the autonomous robotics system should and will need to receive, in order for it be allowed for use in today’s society. in a similar fashion, the sae j3016 version for surgical robotics should follow in the same manner. a level zero classification would consist of only human operation with non-surgical robotic assists. in a modern world of medicine, this would be your regular check-up in the doctor’s office. a level one and two classification would consist of dominantly human operation with minor or partial usage of surgical robotics. an example of a level one and two classification would be the usage of small high-quality cameras that are used during laparoscopy surgery. the rationale behind such a classification is that the doctor uses instruments controlled by their hands and guided by the camera.174 here, though robotic systems are used, they are in full control by the doctor or surgeon. through analogy, this would be the same as a vehicle’s review or side camera system. level three and four would consist of the surgical robotics that is in use today, such as the “da vinci, sensei x robotic, corpath 200, vdrive robotic.”175 as explained earlier in the note, these surgical robots are not completely autonomous, but rather they are classified as semi or partially autonomous. lastly, the level five classification is left for the futuristic development of complete autonomous robotics. though fully autonomous robotics currently do not exist in today’s medical realm, creating a possible 171. u.s. dot chooses sae j3016 for vehicle-autonomy policy guidance, sae int’l (sept. 20, 2016), http://articles.sae.org/15021/ [https://perma.cc/sl8d-hzyq]. 172. id. 173. id. 174. cameras becoming instrumental in successful surgeries, aia vision online (jan. 12, 2016), https://www.visiononline.org/blog-article.cfm/cameras-becoming-instrumental-insuccessful-surgeries/3 [https://perma.cc/7ets-ndlk]. 175. densford, supra note 49. 2020] the legal battle with the future of autonomous surgical robotics 389 statutory structure on how to regulate and or handle legal disputes would not only allow for a swift transition, it would additionally stimulate development and future usage. even though this only a basic classification system with little or no qualification determinates, below will analyze and discuss what features and functions will help determine how autonomous a robotics system should be classified as and determine what regulation should be applied. b. foundational element requirements elements one through three will focus on system safety, operational design domain, and object and event detection and response.176 thus, by applying similar language and foundational concepts used to determine the level of autonomy in a vehicle, one should be able to transition and transform said language and conceptual notions in order to readily classify and determine the level of autonomy in surgical robotics. this note will only be addressing elements one, two, and three as they are the key foundational elements in order to obtain the result of creating a regulatory bill for the future usage of fully autonomous robotics. 1. element one system safety: is an element that emphasizes regulations upon autonomous surgical robotics. in sum, any entities that are manufacturing, developing, and or creating fully autonomous surgical robotics need to follow and adopt the best practices, design principles, standards, and processes available from other industries such as aviation, space, military, and the automotive industries.177 by requiring such adoptions of other industries’ standards, we as a legal community can help promote that any surgical robotics system that will be used is as free from unreasonable safety risks as possible. ensuring that the risk for failure and or malfunction is minimal is a cornerstone that all industries should strive for. the legal consequences for not meeting the requirements of element one would be either the product not being approved by the food and drug administration and/or a heavy fine. 2. element two operational design domain: in the realm of autonomous vehicles, this elemental lays down basic requirements that all autonomous vehicles should maintain before being approved for society usage. instead of requiring surgical robotics to maintain capabilities such as road type classification and speed range, we should require the classification of environmental conditions in which 176. u.s. dep’t of transp. & nat’l highway traffic safety admin., supra note 65. 177. id. 390 indiana health law review [vol. 17:367 operation can occur.178 element two for surgical robotics would consist of types of surgical usage. examples being: type of operation, success rate, quickness of operation, and error rate (compared to if the same operation was done by a human). these requirements would have been known by all parties involved in the operation, ie. doctor/surgeon, manufacture, operator, and the patient who is receiving the operation. the legal importance behind element two would focus on tort defense and liability. if parties all are informed about all aspects of the surgical robotics system, it would help reduce legal questions as what was seen and dealt with in the washington supreme court case.179 overall, requiring the industry of surgical robotics to meet the standards of element two would help clean up and make court cases involving completely autonomous surgical robotics failure easier and more readily determinable by judges and lawyers. 3. element three object and event detection and response: would be an elemental requirement that would force entities to have clear and readily available documentation of assessment, testing, and validation of their autonomous robotic system’s capabilities.180 not only would this be important for legal consequences, but it would also be significant for the growth and development of surgical robotic systems. in terms of legal significance, requiring documentation would allow courts, judges, and lawyers to determine whether it was manufacturing error, process error, or operator error. meaning, it will not by itself determine who is liable for the system failure, however, it will provide a better insight into what parties are allowed to be sued. overall, requiring the following of element three would create an environment of efficiency, which would develop better law when having to handle issues surrounding surgical robotic system failure.181 as stated earlier, this problem of handling the future notion of fully autonomous robotics is one that is complex. as such, this potential solution is only foundational in nature. in the years to come, more research and knowledge is going to be obtained to develop a bill that can meet all concerns and problems associated with fully autonomous robotics. overall, the legal community must develop something that is similar in nature to the possible solution stated above. this request is not one of personal concern, but rather can be reflected in the current legal issues already arising out of the semi-autonomous surgical robotics as mentioned above. 178. id. 179. taylor v. intuitive surgical, inc., 187 wn.2d 743, (wash. 2017) (the main issue in the case was what party was most liable when a semi-autonomous robotic system failure occurred. emphasized the notion of comparative negligence making all parties involved, including the patient to be considered liable). 180. u.s. dep’t of transp. & nat’l highway traffic safety admin., supra note 65. 181. id. 2020] the legal battle with the future of autonomous surgical robotics 391 c. legal and ethical significance the importance of determining the level of autonomy between the surgical robotics we have today and those in the future is reflected by both legal and ethical significance. as thomas claburn alluded to in his article, surgical robotics and self-driving cars have already started to create legal and ethical “headaches.”182 a legal and ethical headache on its face might come off as minor significance, however, that may not be the case. as stated earlier, historic practices, regulations, and policies have played vital roles in developing solutions for problems that occur at a later date. policies adapt as time changes, case precedents are used for years, and regulations are shaped in order to combat changes and provide the best results. thus, as thomas claburn alluded to in his article, examining the legal “headaches” that have occurred with semiautonomous surgical robotics and self-driving cars may create a possible solution for both legal and ethical problems associated to the development of fully autonomous robotics.183 as examined above, courts have struggled to determine what parties should be liable when surgical robotics failure occurs.184 courts have typically taken the route that all parties involved in the manufacturing, usage, upkeep, and even in some cases, the patient are all liable in some sort of way.185 thus, creating a legal precedent of being able to sue any parties that had any contact and/or part in the creation and usage of surgical robotics. as time moves forward and surgical technology rapidly advances, specific parties will be further extended from direct care to the development and usage of the robotics.186 specifically, it would be extended to the surgeon or doctor who would be using said robotics during operational procedures.187 as such, it would be both legally and ethically unjust to allow parties to sue an individual who cannot be directly attached for being a cause for the robotics failure. though this is just one hypothetical situation in which legal questions and concerns arise. it nevertheless demonstrates the significance in the determination of whether a robotics system is either partial or fully autonomous and the result of different legal ramifications for parties involved. as briefly mentioned above, there is also ethical significance attached to the usage of advanced autonomous robotics. this ethical significance mainly falls, as fanny ficuciello and associates determined, around the sharing of 182. claburn thomas, robo-surgeons, self-driving cars face similar legal, ethical headaches, the reg. (july 13, 2017), https://www.theregister.co.uk/2017/07/13/robot_surgeons_face_same_ obstacles_as_selfdriving_cars/ [https://perma.cc/n8rw-zeuk]. 183. see id. 184. wu, supra note 158. 185. id. 186. thomas, supra note 182. 187. see id. 392 indiana health law review [vol. 17:367 responsibility between the doctor and robotics performing the surgery.188 meaning, who or which party is morally liable in the situations where the robotics fail.189 this is not only a true ethical problem but also a legal one. the result for the legal problem may be justified in which party is at fault, however, the notion of an ethical/moral factor may generate a different solution. is it ethically justified to always blame the doctor? this notion of ethical significance is something that lawmakers and practicing judges and lawyers must keep in the back of their minds when handing down judgments or passing statutes. the legal solution may be correct for the given situation, but the ethical issues involved must also be weighed into the formulation of the overall solution. as in most things relating to health care, medical practices, and surgeries, the concept of innocent individuals’ lives being impacted is something that should be recognized. as society is rapidly developing towards fully autonomous surgical robotics, the notion of humanity must not be forgotten. viii. conclusion though there is already foundational law and statutes governing the uses and standards of autonomous robotics, this does not solve the foreseeable problems in the near future. as autonomous robotics continue to develop and grow at rapid rates, the law and statutes governing them need to as well. if the law does not follow in suit, this could potentially create legal gaps in handling of future disputes. as this note highlights, one of these potential legal gaps can be seen within the notion of complete autonomous surgical robotics and its relation to medical malpractice and products liability. though some critics may claim that the notion of complete autonomy is one of far fetch nature, it has been clearly proven throughout this note that is not true. if no such solutions are developed in order to handle the regulations and the legal conflicts, we as a society run the risk of overloading not only our judicial system but our nation’s policymaking body. as technology develops at an unprecedented rate, the need for an in-depth examination of the concepts, possibilities, problems, and possible legal solutions is needed in order to help handle and maintain all issues and regulations that will occur for the use of fully autonomous surgical robotics. 188. ficuciello fanny et. al., autonomy in surgical robots and its meaningful human control, 10 paladyn, j. behav. robotics 30 (2019). 189. see id. the right to be forgotten: applying european privacy law to american electronic health records jordan d. brougher i. introduction ............................................................... 510 a. the issue: hippa’s inability to protect patient health records .................................................. 513 b. european issues with health record data breaches ................................................................. 519 ii. background ............................................................... 520 a. development of the european union’s right to be forgotten ......................................................................... 520 b. development of the united states’ hipaa law ...... 527 iii. analysis: applying europe’s right to be forgotten to americans’ health records .................. 533 a. what an american health care privacy right to be forgotten might look like ......................... 533 b. problems with an american right to be forgotten .................................................................... 537 c. solutions .................................................................... 541 iv. conclusion ............................................................... 544 i. introduction imagine jane doe wakes up one morning and turns on the local news to find her health insurance provider, xyz insurance, is the victim of a cyberattack. a few days later she receives a letter informing her of the breach and that her data has been compromised. xyz promises to provide identity theft protection for the next year. jane places the letter in a folder containing three similar letters from other  j.d. candidate, 2016, indiana university robert h. mckinney school of law; b.s., 2011, indiana university. i would like to thank my wife, kourtney, and the rest of my family for their continued love and support. http://dx.doi.org/10.18060/3911.0025 2016 511 the right to be forgotten: applying european privacy law to american electronic health records corporations which have suffered recent breaches. she feels helpless as cybercriminals now have access to her private medical information. with the 2014 and 2015 data breaches at major corporations like sony pictures, community health services, target, and most recently anthem, our individually identifiable medical information becomes increasingly at risk. large corporations like sony pictures and anthem store their employees’ personal information through a system of electronic records.1 the sony cyberattack occurred during the build-up to the release of a comedy film depicting the attempted assassination of the north korean supreme leader, kim jong-un.2 the attack illustrates a great cause of concern for employees across the united states. employers hold valuable employee information such as social security numbers, salaries, performance reviews, and personal medical information.3 additionally in february 2015, anthem, one of the nation’s largest health insurers, headquartered in indianapolis, reported a breach that could affect up to 80 million customers and employees.4 anthem ceo, joseph r. swedish, believes the hack to be a “very sophisticated external cyberattack” with the cybercriminals accessing personal information like social security numbers and birthdates.5 however, the federal bureau of investigation is looking into whether health information was stolen or not.6 1 cyberattacks are performed by groups targeting employee and customer stored information such as social security numbers, credit card information, and health information within the targeted companies’ computer systems. andrea peterson, lawsuits against sony pictures could test employer responsibility for data breaches, wash. post (dec. 19, 2014), http://www.washingtonpost.com/blogs/the-switch/wp/2014/ 12/19/lawsuits-against-sony-pictures-could-test-employer-responsibilityfor-data-breaches/ [http://perma.cc/u36e-u8bw]. 2 see id. 3 id. 4 reed abelson & matthew goldstein, millions of anthem customers targeted in cyberattack, ny times (feb. 5, 2015), http:// www.nytimes.com/2015/02/05/business/hackers-breached-data-ofmillions-insurer-says.html?_r=0 [http://perma.cc/7v4m-c739]. 5 id. 6 id. 512 indiana health law review vol. 13:2 the most troubling part of the cyberattacks is the evidence showing that companies cut corners on data security to save money.7 however, corporations that choose to cut corners ultimately pay a steeper price in the end, as do their employees. by failing to secure protected health information, data breaches can result in hefty fines from the department of health and human services (hhs) and monetary damages in the range of several million dollars.8 a major difference exists between the sony attack and the anthem attack. while sony is a leader in the entertainment industry, anthem is a leader within the health care industry. yet, the sony cyberattack allowed the cybercriminals to gain access to employee medical records including information on surgeries, therapies, and medical diagnoses such as cancer, kidney failure, and premature births.9 even though, cybercriminals mostly use the stolen information for identity theft purposes, there is a potential to use the information in the service of other crimes such as insurance and prescription fraud.10 meanwhile sony will incur liability for the breach as 7 peterson, supra note 1. 8 annually, data breaches cost the health care industry around $5.6 billion, and as more health care providers go to the electronic health record “cloud” this number is expected to continue to increase. jason millman, health care data breaches have hit 30m patients and counting, wash. post (aug. 19, 2014), http:// www.washingtonpost.com/blogs/wonkblog/wp/2014/08/19/health-caredata-breaches-have-hit-30m-patients-and-counting/ [http://perma.cc/ b89l-7x8b] (citing chris burt, data breaches cost healthcare firms $5.6 billion annually: ponemon institute, whir (mar. 19, 2014), http://www.thewhir.com/web-hosting-news/data-breaches-costhealthhealthhealth care-firms-5-6-billion-annuallay-ponemon-institute [http://perma.cc/92vj-2c4u]. 9 peterson, supra note 1. 10 pragati verma, why medical data is vulnerable—and valuable— to cybercriminals, forbes (mar. 12, 2015, 4:59 pm), http://www.forbes.com/sites/teradata/2015/03/12/why-medical-data-isvulnerable-and-valuable-to-cybercriminals/ [http://perma.cc/um4673lm]; see also caroline humer & jim finkle, your medical record is worth more to hackers than your credit card, reuters (sept. 24, 2014), http://www.reuters.com/article/2014/09/24/us-cybersecurityhospitals-iduskcn0hj21i20140924 [http://perma.cc/h9yg-mxf8] (“fraudsters use [health] data to create fake ids to buy medical equipment or drugs that can be resold, or they combine a patient number http://www.thewhir.com/web-hosting-news/data-breaches-cost-healthcare-firms-5-6-billion-annuallay-ponemon-institute http://www.thewhir.com/web-hosting-news/data-breaches-cost-healthcare-firms-5-6-billion-annuallay-ponemon-institute http://www.forbes.com/sites/teradata/2015/03/12/why-medical-data-is-vulnerable-and-valuable-to-cybercriminals/ http://www.forbes.com/sites/teradata/2015/03/12/why-medical-data-is-vulnerable-and-valuable-to-cybercriminals/ http://www.reuters.com/article/2014/09/24/us-cybersecurity-hospitals-iduskcn0hj21i20140924 http://www.reuters.com/article/2014/09/24/us-cybersecurity-hospitals-iduskcn0hj21i20140924 2016 513 the right to be forgotten: applying european privacy law to american electronic health records it is required by california law to keep medical information separate from other employee information in a different security system.11 the sony and anthem cyberattacks show the rapidly increasing inability of the united states’ health information portability and accountability act (hipaa) and subsequent state law to properly motivate companies to protect patient data. the act fails to provide a private right of action for individuals, like the sony employees, who, as a result of their employers’ inability to protect the information, have theirs stolen.12 congress must both strengthen hipaa to better protect individual patient data and provide individuals with a private right of action. this note will discuss the need to strengthen health information data protections under hipaa. in comparing the united states and european union (“eu”) privacy law, the note will address the benefits and shortcomings of each approach. furthermore, the note will look to european law and its “right to be forgotten.” then, the note will apply the principles of the eu right to be forgotten to american health records and health information. finally, the note will address issues pertaining to the right to be forgotten and the reasons why americans do should want the right added to the constitutionally recognized right of privacy. a. the issue: hippa’s inability to protect patient health records health care data has increasingly become the target of data breaches accounting for nearly “43 percent of [all] major data breaches reported in 2013.”13 while some breaches are the result of employee negligence, most are done with with a false provider number and file made-up claims with insurers . . . .”). 11 peterson, supra note 1. 12 health insurance portability and accountability act of 1996 (hipaa), pub. l. no. 104-191, 110 stat. 1936 (1996) (codified as amended in various sections of 42 u.s.c.). 13 millman, supra note 8. 514 indiana health law review vol. 13:2 malicious intent.14 the trend is disturbing, because there are multiple avenues for a breach to occur, and it indicates a lack of security. under the 2009 hipaa breach notification rule, hipaa “covered entities” and their “business associates” must follow federal reporting requirements.15 the requirements necessitate that covered entities notify affected individuals,16 the secretary of the department of health and human services (hhs),17 and, if more than 500 residents of a state are affected, the media outlets serving the state.18 hhs has tracked 944 major breach reports affecting nearly 30 million people.19 steve weisman, a law professor and contributor to usa today, predicts that the source of most data breaches in 2015 will target the health care industry.20 to explain his prediction, weisman focuses on the large amount of information being shared by entities and the lack of proper security.21 weisman’s prediction should frighten the health care industry and the country. patients have few means to persuade health care corporations to adequately protect their information. patients may “shop” around for corporations that will better protect their data. however, patients subject to a health maintenance organization (“hmo”) plan provided by an employer will not have this luxury. under an hmo plan, a patient may only go to doctors, other health care providers, 14 see dan munro, cyber attack nets 4.5 million records from large hospital system, forbes (aug. 18, 2014, 9:01 am), http:// www.forbes.com/sites/danmunro/2014/08/18/cyber-attack-nets-4-5million-records-from-large-hospital-system/ [http://perma.cc/ 8qy2jyk2] (“83.2% of 2013 of patient records breached in 2013 resulted from theft”). 15 hipaa breach notification rule, 45 cfr § 164.404(2016). 16 45 cfr § 164.404 (2016). 17 45 cfr § 164.408 (2016). 18 45 cfr § 164.406 (2016). 19 millman, supra note 8. 20 anthem’s data breach provides concrete evidence that professor weisman’s prediction holds weight and members of the health care industry must strengthen their cyber-security. steve weisman, cyber predictions for 2015, usa today (dec. 20, 2014), http:// www.usatoday.com/story/money/personalfinance/2014/12/20/cyber-hackdata-breach/20601043/ [http://perma.cc/j33h-qjj2]. 21 id. 2016 515 the right to be forgotten: applying european privacy law to american electronic health records and hospitals on the plan’s list.22 since the late 1990s, managed care has dominated the health care marketplace with more than 70 million americans enrolled in hmos and 90 million enrolled in ppos (preferred provider organizations).23 while hmo enrollment numbers have been in decline, managed care is still a dominant form in the health care market place24 and limits the patient’s ability to hold the company accountable in protecting their data. in a recent interview on sound medicine radio, titus schleyer, director of regenstrief center for biomedical informatics in indianapolis, stated “as a patient you are so removed from control over your information that you really can’t do anything.”25 schleyer goes on to argue that stolen health information is of little use to cybercriminals, because the information does not provide as good of a benefit as stolen data like social security numbers and birthdates.26 schleyer’s comments illustrate the miscommunication between patients and providers. patients may believe their information is staying within their providers’ systems when in reality it is being sent to the health storage cloud or to another corporation for storage.27 this reality should be reflected in an informed consent form, (even if patients will 22 health maintenance organization (hmo) plan, medicare.gov, http://www.medicare.gov/sign-up-change-plans/medicare-healthplans/medicare-advantage-plans/hmo-plans.html [http://perma.cc/ax8echqh] (last visited feb. 7, 2016). 23 managed care, market reports and the states, ncsl, http://www.ncsl.org/research/health/managed-care-and-the-states.aspx [http://perma.cc/h4r3-edcs] (updated june 2013). 24 id. 25 in the era of cloud health data, safety is not guaranteed, sound medicine radio (feb. 27, 2015), http://soundmedicine.org/post/eracloud-health-data-safety-not-guaranteed#.vp8djbneq4s.email [http://perma.cc/7rsh-f6zp] (explaining once providers place patient information in ehrs with another corporation or in the health storage cloud, the providers are not even sure where the information is at any given time). 26 id. schleyer’s argument contradicts others regarding the use of health information for criminal purposes. see verma, supra note 10. 27 see erin gilmer, privacy and security of patient date in the cloud, (april 16, 2013), https://www.ibm.com/developerworks/cloud/library/clhipaa/ [https://perma.cc/l4as-scht]. http://www.medicare.gov/sign-up-change-plans/medicare-health-plans/medicare-advantage-plans/hmo-plans.html http://www.medicare.gov/sign-up-change-plans/medicare-health-plans/medicare-advantage-plans/hmo-plans.html http://www.ncsl.org/research/health/managed-care-and-the-states.aspx 516 indiana health law review vol. 13:2 never read the form), that is signed upon the collection of their information. health care industry expenditures made up roughly 17.1% of the united states’ gross domestic product (“gdp”) from 2010-2015.28 the world health organization database calculates the percentage based on expenses both public and private including preventative and curative health services, family planning activities, nutrition activities, and emergency aid.29 to contrast the united states with other economic leading countries, the united kingdom’s expenditures represent only 9.1% of its gdp, and france’s expenditures represent 11.5% of its gdp from 2010-2015.30 the united states must find a way to lower the proportion of health care spending within its gdp. furthermore, corporations in the united states will continue to spend in the billions to rectify patient record security breaches.31 in august 2014, community health services announced the second largest breach in u.s. history affecting more than 4.5 million patients and potentially costing above $77 million in fines and remedies.32 community health services, located in tennessee and serving twenty-nine other states, believes “the attacker was an ‘advanced persistent threat’ group originating from china” targeting community health services systems with “highly sophisticated” technology.33 one of the largest fraudulent uses for stolen health records is medical insurance fraud. the most common method by which criminals fraudulently obtain patient 28 who global health expenditure database, health expenditure, total (% of gdp), world bank, http://data.worldbank.org/indicator/ sh.xpd.totl.zs/countries/1w?display=default [http://perma.cc/6xg7kutp] (last visited feb. 7, 2016). 29 id. 30 id. 31 according to benchmark research performed by the ponemon institute on the cost of data breaches, each compromised record costs the company an average of $201. taking the anthem data breach with nearly 80 million records compromised, it would result in a cost of $16 billion. see ponemon inst. llc, 2014 cost of data breach study: united states 1 (2014), available at http://public.dhe.ibm.com/common/ssi/ecm/ se/en/sel03017usen/sel03017usen.pdf [http://perma.cc/ra6k-r4tu]. 32 munro, supra note 14. 33 id. 2016 517 the right to be forgotten: applying european privacy law to american electronic health records information is by “inducing medical personnel with access to patient insurance information to copy the information and provide it to those involved in fraud schemes”34 and “[p]urchasing the information from others involved in fraud . . . marketers of stolen patient and physician billing information.”35 “estimates of fraudulent billings to health care programs, both public and private, are estimated between 3 and 10 percent of total health care expenditures.” 36 medicare and medicaid have been subject to losses in the billions from healthcare fraud.37 this amount includes provider and patient fraud outside the scope of stolen health care records.38 the government’s health care fraud prevention and enforcement recovered $4.3 billion in taxpayer dollars as part of the obama administration’s attempts to eliminate health care fraud and reduce health care costs.39 with tax-funded programs facing fraud, taxpayers have even more incentive to protect their information in order to potentially lower the taxes necessary to fund these programs. while fraud can come from many sources, not all can be attributed to medical identity theft. for example, stark and anti-kickback violations are 34 white-collar crime, health care fraud overview, the fbi, http://www.fbi.gov/about-us/investigate/white_collar/health-carefraud/health-care-overview [http://perma.cc/b96w-pmd8] (last visited feb. 7, 2016). 35 id. 36 see fed. bureau of investigation, financial crimes report to the public 2007, at 9 (2007), available at https://www.fbi.gov/statsservices/publications/fcs_report2007 [http://perma.cc/fu5j-bbeq] (explaining “[e]stimates of fraudulent billings to health care programs, both public and private, are estimated between 3 and 10 percent of total health care expenditures.”). 37 by the numbers: fraud statistics, coalition against insurance fraud, healthcare, (last visited may 20, 2016) http:// www.insurancefraud.org/statistics.htm#.v0hcxpkrliu. [https:// perma.cc/9acq-x9gf]. 38 id. 39 u.s. dep’t of justice, departments of justice and health and human services announce record-breaking recoveries resulting from joint efforts to combat health care fraud, (feb. 26, 2014), http://www.justice.gov/opa/pr/departments-justice-and-health-andhuman-services-announce-record-breaking-recoveries-0 [http://perma.cc/ gj5p-ekl8]. http://www.justice.gov/opa/pr/departments-justice-and-health-and-human-services-announce-record-breaking-recoveries-0 http://www.justice.gov/opa/pr/departments-justice-and-health-and-human-services-announce-record-breaking-recoveries-0 518 indiana health law review vol. 13:2 frequently found against health care providers claiming more money than they are entitled to.40 as the patient protection and affordable care act (“aca”) became law, the united states started to focus on the soaring costs of the health care industry.41 the aca is an attempt to provide affordable coverage to americans by creating new tax credits and new marketplaces where competition will lead to better prices and better results.42 in the ponemon institute’s “benchmark study on patient privacy & data security”, two-thirds of health care organizations feel the new law increases the risk of data breaches.43 beginning in 2012, aca section 1561 called for the standardization of billing and the adoption and implementation of an electronic exchange of health records.44 the aca increases the concerns over the “exchange of patient information between [healthcare] providers and government organizations.”45 the call for increased electronic health records (“ehr”) combined with organizations’ poor security practices place patient information at risk.46 organizations must take more responsibility under the aca to protect patient information. for example, data encryption should be mandatory for any company device that leaves the office. the aca’s effects on patient information data breaches have yet to materialize, but providers, patients, and the government must do more to protect patient information. 40 u.s. dep’t of health and human servs, medicare fraud & abuse, (aug. 2014), https://www.cms.gov/outreach-and-education/medicarelearning-networkmln/mlnproducts/downloads/fraud_and_abuse.pdf. [https://perma.cc/rx6u-7v6y]. 41 health care that works for americans, whitehouse.gov, http://www.whitehouse.gov/healthreform/healthhealthhealthcareoverview [http://perma.cc/w4rp-hca6] (last visited feb. 7, 2016). 42 id. 43 jeffrey bendix, healthcare data breaches decline, but aca could be increasing risks, med. econ. (may 15, 2014), http://medicaleconomics.modernmedicine.com/medicaleconomics/content/tags/affordable-care-act/healthcare-data-breachesdecline-aca-could-be-inc?page=full [http://perma.cc/8phj-fwbw]. 44 42 u.s.c. § 300jj-51 (2015). 45 bendix, supra note 43. 46 id. http://www.whitehouse.gov/healthreform/healthcare-overview http://www.whitehouse.gov/healthreform/healthcare-overview http://medicaleconomics.modernmedicine.com/medical-economics/content/tags/affordable-care-act/healthcare-data-breaches-decline-aca-could-be-inc?page=full http://medicaleconomics.modernmedicine.com/medical-economics/content/tags/affordable-care-act/healthcare-data-breaches-decline-aca-could-be-inc?page=full http://medicaleconomics.modernmedicine.com/medical-economics/content/tags/affordable-care-act/healthcare-data-breaches-decline-aca-could-be-inc?page=full 2016 519 the right to be forgotten: applying european privacy law to american electronic health records b. european issues with health record data breaches the united states is not alone in experiencing patient information data breaches. in a 2014 study, by the central european university’s centre for media, data and society (cmds) reported that shows the european union’s twentyeight countries of the eu have suffered 229 known data breaches “covering 227 million personal records.”47 however, the european union addresses individual privacy rights much differently than the united states does. the eu acknowledges privacy as a fundamental right.48 european institutions have a difficult time defining what the right entails and instead take “a piecemeal approach to defining private life, rather than providing a general or exhaustive definition.”49 although the right to privacy has not been given a general definition, the eu has passed several directives to bring the right into the twenty-first century. for example, the 2002 e-privacy directive requires breaches of personal data to be reported to national authorities and may help provide a clearer picture on the actual number and scope of breaches in european countries.50 finally, the eu encourages the adoption of ehrs and confirmed the broad application of privacy protections.51 these directives and suggestions promoted the access of information across various countries. while the 47 john e. dunn, europe suffered 229 public data breaches since 2004, idg news serv. (oct. 13, 2014), http:// www.techcentral.ie/european-suffered-229-public-data-breaches-since2004-study-suggests/ [http://perma.cc/3kcp-qj8z]. 48 see convention for the protection of human rights and fundamental freedoms art. 8, nov. 4, 1950, 213 u.n.t.s. 222, 230 [hereinafter convention]. 49 h. tomás gómez-arostegui, defining private life under the european convention on human rights by referring to reasonable expectations, 35 cal. w. int’l l.j. 153, 154 (2005). 50 directive 2002/58/ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector, 2002 o.j. (l 201) 37 [hereinafter e-privacy directive]. 51 janine hiller, et al., privacy and security in the implementation of health information technology (electronic health records): u.s. and eu compared, 17 b.u. j. sci. & tech. l. 1, 2 (2011). 520 indiana health law review vol. 13:2 united states also seems to be pushing to make ehrs the predominate form of record keeping through the hitech act, unfortunately they have not been able to promote patient privacy on the same level as the eu. ii. background a. development of the european union’s right to be forgotten european and american ideas on individual privacy have gone in opposite directions. in 1950, the european convention for the protection of human rights and fundamental freedoms declared that, “[e]veryone has the right to respect for his private and family life, his home and his correspondence.”52 in 1995, the eu made the data protection directive into law, which includes the principal creating the right of erasure.53 the right of erasure allows a subject to erase data, which is “incomplete, inaccurate, or stored in a way incompatible with the legitimate purposes pursued by the controller.”54 additionally, article 12 of the data protection directive reads, “[m]ember states shall guarantee every data subject the right to obtain from the controller . . . as appropriate the rectification, erasure or blocking of data….”55 furthermore, article 2 defines “controller,” as “the natural or legal person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data.”56 the directive allows individuals some 52 see convention, supra note 48. 53 factsheet on the “right to be forgotten” ruling, european commission, (c-131/12), http://ec.europa.eu/justice/data-protection/files/ factsheets/factsheet_data_protection_en.pdf. [https://perma.cc/s33fnwha]. 54 directive 95/46/ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, 1995 o.j. (l 281) 32 [hereinafter eu data protection directive]. 55 id. at art. 12. 56 id. at art. 2. 2016 521 the right to be forgotten: applying european privacy law to american electronic health records control over the data that is processed by corporations and other entities. the eu data protection directive would have little to no authority if it did not apply to non-eu companies, and thus, it applies to any company that may reach within the eu. in 1991, the eu council adopted recommendations governing the flow of data across its borders.57 the adoption of these recommendations is especially important when dealing with foreign companies possessing data of eu citizens. additionally, article 8 of the eu data protection directive prohibits the processing of personal data, “concerning health or sex life.”58 the eu data protection directive formed the article 29 working party, as an advisory board on data protection.59 the article 29 working party issued the working document on the processing of personal data relating to health in electronic health records.60 the report applies privacy principles to health records and “recommends [the] adoption of eleven specific legal protections to protect individual health privacy.”61 the report characterizes health data as being relevant to the treatment of the patient. otherwise, it should not be included in the patient’s medical file.62 while these examples do not represent health data, they provide identifiable information that may trace de-identified health data back to the patient. such information may hold relevance to a patient’s history but often not to the patient’s health. however, there are some exceptions where the information is extremely relevant. for example, a factory worker exposed to asbestos for thirty years will be relevant to the fact that the worker suffers from mesothelioma. 57 recommendation no. r (91) 10 of the committee of ministers to member states on the communication to third parties of personal data held by public bodies, council of europe (sept. 9, 1991), available at https://wcd.coe.int/com.instranet.instraservlet?command=com.instranet .cmdblobget&instranetimage=572401&secmode=1&docid=597936&u sage=2 [http://perma.cc/ n3rb-39hu]. 58 eu data protection directive, supra note 54. 59 hiller, et. al, supra note 51 at 21. 60 id. 61 id. 62 id.at 22. 522 indiana health law review vol. 13:2 the eu system represents a huge victory for individual privacy rights by giving the individual control over what information the medical provider may collect and store. in 1980, the organization for economic cooperation and development (“oecd) issued guidelines on the protection of privacy and transborder flows of personal data (oecd privacy guidelines”).63 the oecd privacy guidelines operate on the principle of limiting data collection and use for only specific purposes.64 it is noted that the guidelines put forth principles such as: “limitation of data collection, maintenance of data quality, specification of the collection purpose, limitation of data use to that specified purpose, adequate security, transparency, individual access to and control of data collected, and accountability.”65 in 1998, with the rapidly improving technological world the oecd reexamined the principles and reaffirmed their application.66 however, oecd privacy guidelines remain limited in their application to health data. to protect individuals’ health data, the european union decided to address this issue. in 2012, the european union put forth a proposal to further protect individuals’ privacy rights. the proposal provides article 17 the “right to be forgotten and to erasure.”67 three sections compose article 17’s right to be forgotten and to erasure. first, section 1 provides individuals with the “right to obtain from the controller the erasure of personal data relating to them and the abstention from further dissemination of such data, especially in 63 oecd, guidelines on the protection of privacy and transborder flows of personal data (paris 1981), available at http:// www.oecd.org/sti/ieconomy/oecdguidelinesontheprotectionofprivacyandtr ansborderflowsofpersonaldata.htm [https://perma.cc/2rn8-p425]. 64 id. 65 hiller, et. al., supra note 51 at 20. 66 see oecd, protection of privacy and personal data, oecd.gov, http://www.oecd.org/document/26/0,3343,en_2649_34255_1814170_1_1_ 1_1,00.html [http://perma.cc/k8la-ggwk] (last visited on feb. 7, 2016). 67 proposal for a regulation of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data, com (2012) 11 final (jan. 25, 2012), available at http://eur-lex.europa.eu/legalcontent/en/txt/pdf/?uri=celex:52012pc0011&from=en [http://perma.cc/4zy8-82a4] [hereinafter general data protection regulation]. http://www.oecd.org/document/26/0,3343,en_2649_34255_1814170_1_1_1_1,00.html http://www.oecd.org/document/26/0,3343,en_2649_34255_1814170_1_1_1_1,00.html 2016 523 the right to be forgotten: applying european privacy law to american electronic health records relation to personal data which are made available by the data subject while he or she was a child.”68 section 2 includes the obligation of the controller who has made the information public to inform third parties of the data subject’s request “to erase any links to, or copy or replication that personal data.”69 section 3 charges the controller to take down the information “without delay” and creates exceptions where retention of personal data is necessary.70 the exceptions include the exercise of “freedom of expression” such as works designated as artistic, literary, or journalistic; public health interest; “historical, statistical, and scientific research”; and retention of personal data by the eu or member state under state law.71 the general data protection regulation was designed to meet the rapid advances in technology and provide individuals with protections against companies that make use of personal data.72 the regulation’s purpose is to build trust in the online environment to propel economic development; and as of april 14, 2016, the general data protection regulation passed into law.73 the right to be forgotten had little authority over the various corporations doing business in the eu, until 2013 when spanish courts decided a case with immense implications to the right. in 2013, the spanish courts decided google spain sl, google inc. v. agencia espanola de proteccion de datos, mario costeja gonzalez. the decision required internet search engines to consider individual requests to remove links to freely accessible web pages resulting from a search of the individual’s name.74 the case was brought by a man 68 id. at art. 17. 69 id. 70 id. 71 id. 72 id. 73 zlata rodionova, eu data protection regulation passes in brussels giving citizens right to be forgotten online, (april 14, 2016), http://www.independent.co.uk/news/business/news/european-union-sgeneral-data-protection-regulation-privacy-facebook-data-eu-law-onlineweb-a6984101.html. [https://perma.cc/3rqx-4xtu]. 74 case c-131/12, google spain sl v. agencia española de proteccion de datos, (aepd), 2013 ecli:eu:c:2014:616 (may 13, 2014), available at 524 indiana health law review vol. 13:2 whose name was printed in an announcement of a newspaper widely circulated throughout spain in connection with a property that was up for auction due to social security debts.75 the man was named as the owner.76 at a later date, an electronic version of the newspaper was made available.77 in 2009, the man searched for his name on google and found the newspaper announcements from eleven years prior.78 the man asserted article 12 of the eu data protection directive as the basis of his argument to require google to erase the search results.79 in its decision, the court reasoned that while the general data protection regulation in article 17 provides for a right to be forgotten, it does not represent a codification of current law.80 however, the court did find that the right of erasure is valid when google, acting as a processor of personal data, infringes on the privacy rights of the data subject.81 the decision gives real authority to the eu data protection directive article 12, recognizing the right to erasure in the eu common law. furthermore, the decision requires u.s. companies to adhere to this right to be forgotten when operating within the eu. it remains to be seen the impact this will have on u.s. companies’ operations within the eu and if the right to be forgotten will impact the companies’ data policies within the united states. the google spain sl decision draws parallels to the united states’ supreme court decision in griswold v. connecticut which began the constitutionally recognized right of privacy in the united states.82 in griswold, http://curia.europa.eu/juris/document/document.jsf?text=&docid=152065 &doclang=en [perma.cc/9m35-kev6] [hereinafter google spain]. 75 id. 76 id. 77 id. 78 id. 79 id. (asserting in the complaint by mr. gonzalez that the proceedings that gave rise to the announcements had been resolved several years prior and were no longer relevant. the, though the court found that the newspaper publishing the announcements were right to do so but upheld the complaint against google spain and google, inc.). 80 id. 81 id. 82 griswold v. connecticut, 381 u.s. 479 (1965). 2016 525 the right to be forgotten: applying european privacy law to american electronic health records connecticut had a statute that mandated any individual be fined who used “any drug, medicinal article or instrument for the purpose of preventing conception.”83 griswold, the executive director of the planned parenthood league of connecticut, provided information and drugs to married persons for the “purpose of preventing contraception.”84 she was subsequently fined for her actions.85 the court found the bill of rights and its amendments create “zones of privacy.”86 for example, the fourth amendment provides an individual’s right from “unreasonable searches and seizures” of their homes.87 the court found the constitutionally guaranteed zones of privacy extended to marital privacy.88 griswold, much like google spain in the eu, represents the beginning of constitutionally protected privacy rights in the united states. in applying the eu data protection directive to the health care industry, article 29 of the data protection working party is dispositive for the eu health care industry. under article 29, the working document on the processing of personal data relating to health in electronic health records provides requirements for health information gathered by health care professionals in electronic form.89 health information gathered must be for the purposes of “preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services” the health professional processing the information must be bound by law or professional rules to professional secrecy or the ‘equivalent.’90 83 id. at 480 (citing now repealed conn. gen. stat. § 54-196 (1958)). 84 id. 85 id. 86 id. at 484. 87 id. at 484. 88 id at 485. the constitutionally guaranteed zones of privacy are no longer applicable. in subsequent cases the zones of privacy have been replaced and a right to privacy has been founded in the 14th amendment’s due process clause. see roe v. wade, 410 u.s. 113 (1973), note 96. 89 article 29 of directive 95/46/ec, working document on the processing of personal data relating to health in electronic health records (ehr), 2007 o.j. (wp 131), available at http:// ec.europa.eu/justice/policies/privacy/docs/wpdocs/2007/wp131_en.pdf [http://perma.cc/e6sy-95pa] [hereinafter article 29]. 90 id. 526 indiana health law review vol. 13:2 the eu created ehealth as its electronic health record database.91 the ehealth database provides europeans with access to their medical data while incorporating the right of individuals to have their medical data safely stored on an accessible online health care system.92 european ehrs require prior patient consent, but once given, providers can freely access, store, and transmit the information.93 the main obstacle to ehealth’s success is concern over data protection and privacy.94 similar to the concerns in the united states electronic health record system, in the eu “there is still lack of trust in the security of the system and [patients] are reluctant to use it.”95 this distrust stems from a concern over access to the information.96 additionally, patients and providers express concerns on data privacy but also concern on “overly strict data protection.”97 to combat these concerns, the ehealth stakeholders put forth recommendations as to how to properly secure patient information.98 one recommendation, guaranteeing privacy and data protection, grants patient’s control over their own medical file.99 the patient is in charge of his or her own file, allowing the patient to “log-in” and inspect it.100 the eu finds the option to access one’s own information as a fundamental right under the eu data protection legislation.101 the united states should grant patients 91 directive 2011/24/eu, of the european parliament and of the council of 9 march 2011 on the application of patients’ rights in crossborder healthcare o.j. (l 8845) [hereinafter directive on cross-border health care]. 92 patient access to electronic health records, ehealth stakeholder group, 1 (2013), available at http:// ec.europa.eu/newsroom/dae/document.cfm?doc_id=5169 [http:// perma.cc/8g6p-ynwq] [hereinafter ehealth report]. 93 id. at 2-3. 94 id. 95 id. at 3. 96 id. most concern is over the “who and how” of data access. stakeholders remain tentative, because ehrs carry a general uncertainty of who is responsible for the information. 97 id. at 4. 98 id. at 14. 99 id. 100 id. 101 id. 2016 527 the right to be forgotten: applying european privacy law to american electronic health records similar access to their own files. this way the patient will have the opportunity to become more involved in their recordkeeping and have some sense of security even if it is small. however, it is argued that “an ehr in the united states will challenge the presumption of privacy preservation.”102 with records easily transferable between providers, the individual’s ability to maintain privacy is limited. this is a problem in the eu as well, but if the recommendations presented by ehealth take hold, then the patient will be able to see who accessed their information and for what purpose.103 yet, with the increase in medical data breaches, ehrs should strengthen the presumption of privacy. if the united states health care industry cannot protect health records, then the decision of what non-treatment related information is in the records should be made by individuals. b. development of the united states’ hipaa law the united states codified its concern for privacy in the various amendments constituting the bill of rights. for example, the fourth amendment protects against unreasonable search and seizures104 and the first amendment’s freedom of association.105 with griswold v. connecticut, the seminal case on u.s. privacy rights, the supreme court recognized a constitutional right to privacy.106 griswold began a snowball effect for privacy rights, including roe v. wade107 and cruzan v. director, missouri department of health.108 however, the court has 102 hiller, et al., supra note 51 at 23. 103 ehealth report, supra note 92. 104 u.s. const. amend. iv. 105 u.s. const. amend. i. 106 griswold v. connecticut, 381 u.s. 479, 485 (1965). 107 roe v. wade, 410 u.s. 113 (1973). in this right to abortion case, the court found “the right [of privacy]…includes the right of a woman to decide whether or not to terminate her pregnancy.” id. at 170. 108 cruzan v. dir., mo. dep’t of health, 497 u.s. 261 (1990). in this end of life case, the court assumed a person’s right to refuse treatment to be a liberty interest (a right not to be infringed upon by the government, state or federal) protected by the due process clause and 528 indiana health law review vol. 13:2 not recognized a constitutional right to privacy of health data. in whalen v. roe, the supreme court recognized a limited constitutional right to individual privacy with respect to information held in government databases.109 however, the decision left unresolved the issue of a constitutional protection of health information. with the privacy act of 1974, congress created a law that applies to personal information in any federal government record within federal agencies.110 then, with the gramm-leach-bliley financial services modernization act of 1999, congress protected financial information held by health insurers.111 wanting an expanded right to privacy yet to be court recognized within the various constitutional amendments, samuel warren and louis brandeis wrote that there should be a right “to be let alone” from instantaneous photographs and newspaper enterprise invading the private and domestic life.112 however, the supreme court did not recognize the right to privacy within the bill of rights until much later.113 congress was the first to act to protect privacy rights regarding health data.114 health insurance portability and accountability act of 1996 (“hipaa”) started the united states’ move toward ehrs. the u.s. legal framework for health information privacy is codified in hipaa.115 hipaa “originally gave congress three years to pass explicit privacy rules.”116 after went through a due process clause analysis weighing the state interests against cruzan’s liberty interests. id. at 279. 109 whalen v. roe, 429 u.s. 589 (1997). 110 privacy act of 1974, 5 u.s.c. § 552a (2016). 111 gramm-leach-bliley financial services modernization act of 1999, pub. l. no. 106-102, 113 stat 1338. 112 samuel d. warren & louis d. brandeis, the right to privacy, 4 harv. l. rev. 193, 195 (1890). 113 griswold v. connecticut, 381 u.s. 479, 481 (1965) (deciding the right to contraception was a privacy right found within the constitutional amendments, but later the right to privacy is found in the due process clause of the 14th amendment). 114 health insurance portability and accountability act of 1996 (hipaa), pub. l. no. 104-191, 110 stat. 1936 (1997) (codified as amended in various sections of 42 u.s.c.). 115 id. 116 hiller, et al., supra note 51 at 11. 2016 529 the right to be forgotten: applying european privacy law to american electronic health records this time expired and no privacy rules were passed, the department of health and human service (“hhs”) “became the authority in privacy regulations.”117 hipaa was a congressional attempt to provide administrative simplification of the health care system through a health information system with the electronic transmission of certain health information.118 hhs began to adopt a set of rules to govern health information privacy with the privacy rule.119 the privacy rule has three purposes best described in three words: protect – safeguard the rights of consumers “by providing them access to their health information” and restricting the inappropriate use; trust – “improve the quality of health care” by “restoring trust” between those supplying and seeking health care; improve – develop a “national framework for health privacy protection” to improve “efficiency and effectiveness.” 120 next, the hhs passed the security rule. the security rule creates standards for the measures to be taken when “covered entities” obtain custody of health information. these standards apply to communication of health information between “covered entities” and “business associates.”121 section 160.103 of the federal regulations defines covered entity to mean “(1) a health plan[,] (2) a health care clearinghouse[, and] a health care provider who transmits any health information in electronic form.”122 in 2009, congress strengthened hipaa’s privacy and security rules through the hitech act. hitech also clarified the business associate requirements.123 hitech defines business associate as “a person who on behalf of such covered entity or of an organized health care arrangement in 117 id. 118 health insurance portability and accountability act of 1996 (hipaa), pub. l. no. 104-191, 110 stat. 1936 (1996) (codified as amended in various sections of 42 u.s.c.). 119 id. 120 standards for privacy of individually identifiable health information, 65 fed. reg. 82462 (dec. 28, 2000) (to be codified at 45 c.f.r. pts. 160, 164). 121 health insurance reform: security standards final rule, 68 fed. reg. 8334 (feb. 20, 2003) (to be codified at 45 c.f.r. pts. 160, 162, 164). 122 45 c.f.r. §160.103 (2010). 123 id. 530 indiana health law review vol. 13:2 which the covered entity participates, but other than in the capacity of a member of the workforce of such covered entity or arrangement, creates, receives, maintains, or transmits protected health information.”124 the hitech act increased the strength of hipaa’s privacy security guidelines by increasing enforcement and civil monetary penalties.125 enforcement and civil monetary penalties increased in strength with the breach notification rule codified within 45 c.f.r. §§ 164.400-14.126 the breach notification rule requires “covered entities” and business associates to notify the individual affected in cases of 500 or less, but the local media must be informed when 500 or more residents of a state are affected by a breach.127 also, the rule allows the secretary of hhs to post on the hhs public website the names of each covered entity involved in a breach of more than 500 individuals.128 for example, the community health systems (“chs”), inc. breach affected 4.5 million people, and chs is posted on the hhs public website.129 applying the heightened civil penalties under the hitech act, chs could be fined millions of dollars by hhs.130 the breach was a result of a chinese cyberattack that affected 4.5 million patients.131 despite the fact that no health-related information was stolen, the stolen information included identifiable data such as birthdates and telephone numbers.132 although stolen in a sophisticated attack, this leak of information still constitutes a breach under hipaa.133 according to the hipaa breach notification rule, hhs 124 id. 125 hiller, et al., supra note 51 at 12. 126 45 c.f.r. §§ 164.400-14 (2013). 127 45 c.f.r. § 164.408 (2013). 128 id. 129 munro, supra note 14. 130 id. 131 nicole perlroth, hospital company hacked, affecting 4.5 million patients (hack of community health systems affects 4.5 million patients), n.y. times, (aug. 19, 2014), available at http:// bits.blogs.nytimes.com/2014/08/18/hack-of-community-health-systemsaffects-4-5-million-patients/?_r=0 [https://perma.cc/rh7t-svqj]. 132 id. 133 munro, supra note 14. 2016 531 the right to be forgotten: applying european privacy law to american electronic health records required chs to contact the patients and notify hhs because it affected more than 500 individuals.134 in working through the details of hipaa and understanding protected health information, one must understand the role played by covered entities and business associates. originally, hipaa only regulated covered entities with regards to protected health information.135 it completely left out entities essential to the exchange of health information, i.e. business associates.136 subsequent changes to the hipaa law broadened its application to business associates, and the hitech strengthened its enforcement against business associates involved in a data breach.137 hipaa goes on to distinguish between two types of disclosures: permissive and required disclosures. “required disclosures include a covered entity’s provision of a patient’s own protected health information to the patient or patient’s representative, and requests by the hhs secretary for phi for audit or enforcement.”138 on the other hand, permissive disclosures are all other disclosures that fit two categories: those without patient authorization and those that require patient authorization.139 disclosures without patient authorization include exchanges between providers regarding the treatment of a patient and billing for services.140 disclosures requiring patient authorization include exchanging information with the patient’s 134 see 45 c.f.r. § 164.408 (2013). 135 health insurance portability and accountability act of 1996 (hipaa), pub. l. no. 104-191, 110 stat. 1936 (1996) (codified as amended in various sections of 42 u.s.c.). 136 hiller, et al., supra note 51 at 121. 137 with the expansion of ehrs in the last decade, this change to hipaa has helped bring accountability to organizations that may contribute to a breach, but patients deserve heightened rights to protect their own data. id. at 12-14. 138 melissa goldstein, lee repasch & sara rosenbaum, chapter 6: emerging privacy issues in health information technology, in health information technology in the united states: where we stand 97 (david blumenthal et al. eds., 2008), available at https:// folio.iupui.edu/bitstream/handle/10244/784/hitreport.pdf [http:// perma.cc/ sse5-buhs]. 139 id. 140 id. 532 indiana health law review vol. 13:2 representative and requests by the hhs for enforcement purposes.141 protected health information means “individually identifiable health information” that is held or transmitted by a covered entity in any form or media.142 patient authorization is required when the provider is receiving some form of remunerations for the exchange.143 however, no authorization is required to share health information when being treated, securing payment, or in performing health care operations.144 disclosure should be limited to the “minimum necessary.”145 a covered entity may share deidentified information to help improve the public’s understanding of the quality of health care.146 under hipaa, enforcement is left to the secretary of hhs. there is no private right of action under hipaa (federal law).147 some states provide a private cause of action148 under state hipaatype statutes, such as california, for example.149 this represents a conscious decision on the part of congress to favor the exchange of protected health information over patient privacy rights.150 only hhs has jurisdiction to enforce hipaa and seek penalties for hipaa violations. hipaa violations can include 141 id. 142 45 c.f.r. § 160.103 (2010). 143 summary of the hipaa privacy rule, u.s. dep't of health & human services, summary of the hipaa privacy rule at 3 (2003), http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacys ummary.pdf. 144 american recovery and reinvestment act of 2009, pub. l. no. 111-5, § 13405(d), 123 stat. 115, 264 (2009). 145 id. 146 id. 147 id. 148 see daniel j. gilman & james c. cooper, there is a time to keep silent and a time to speak, the hard part is knowing which is which: striking the balance between privacy protection and the flow of health care information, 16 mich. telecomm. & tech. l. rev. 279, 302, 309 (2010). 149 for example, the california hipaa-type statutes regulate the disclosure of medical information by providers and actions that can be brought by unlawful disclosure of patient information. cal. civ. code § 56.10-16 (2014). 150 see id. http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf 2016 533 the right to be forgotten: applying european privacy law to american electronic health records civil and potentially criminal penalties.151 there are differing degrees of penalties depending on the intent of the violation.152 penalties can be levied against both business associates and covered entities.153 enforcement examples can be seen on the hhs website where companies are listed that had a breach affecting more than 500 individuals.154 however, individuals should have a private right of action at the federal level. it is their health information that is being mishandled and stolen. they are suffering harm that may become irreparable. stolen personal information can lead to identity theft. identity theft can ruin an individual’s credit score and lead to financial losses when the theft includes social security numbers and birth dates. for medical identity theft, it could lead to confusion of medical history along with financial loss. moreover, none of these risks are confined by state borders. after seeking treatment for an ailment, no one wants to have to worry about someone stealing that information. health care corporations and the government must take extra steps to protect health records or give individuals the right to determine when and what nontreatment-related information is included in them. iii. analysis: applying europe’s right to be forgotten to americans’ health records a. what an american health care privacy right to be forgotten might look like in general, the eu has continuously provided greater individual privacy rights than the united states.155 it is time 151 american recovery and reinvestment act of 2009, pub. l. no. 111-5, § 13410 (a), 123 stat. 115. 152 id. 153 id. 154 45 c.f.r. § 164.408 (2013). 155 bob sullivan, ‘la difference’ is stark in eu, u.s. privacy laws, nbc news, (october 19, 2006), http://www.nbcnews.com/id/15221111/ns/ technology_and_science-privacy_lost/t/la-difference-stark-eu-us-privacylaws/#.v0hn-_krliu. [https://perma.cc/hj33-xtmt]. see also convention, supra note 48. see also article 29, supra note 91. see directive on cross-border healthcare, supra note 90. see eu data protection directive, supra note 53. 534 indiana health law review vol. 13:2 the united states acknowledged individual privacy rights and addressed the recent increase in data breaches by offering greater protection to individuals. to address the united states' lack of health information privacy rights, the government should consider the following steps: explicitly recognize a right to data privacy; pass legislation that strengthens hipaa enforcement granting a private right of action on the federal level; adopt a right of erasure for health data found acceptable to be removed by hhs through administrative notice and comment proceedings; and grant a right to be forgotten in hipaa for information that is breached and released onto the internet. step one: as the united states supreme court has recognized the right to privacy as a fundamental right similar to the eu’s right in their european convention for the protection of human rights and fundamental freedoms,156 the united states needs to pass legislation that would grant an explicit right of privacy for personal data. an american right to data privacy should be similar to a right to privacy found in the french civil code. in article 9, the french code provides for the right to respect of one’s private life157 french courts have interpreted private life to mean “love life, friendships, family circumstances, leisure activities, political opinions, trade, union or religious affiliations, and state of health.”158 acknowledgement of such a right in the united states would allow americans an opportunity to have autonomy over their personal and private data. step two: pass legislation that strengthens hipaa enforcement. legislation should allow a private right of action against hipaa violators in federal court. under paragraph two of article 9 in the french civil code, the court is given the necessary measures to stop those infringing on others’ privacy.159 the united states should address data breaches as an infringement on the patients’ privacy. hipaa 156 see convention, supra note 48. 157 code civil [c. civ.] art. 9 (fr.). 158 french legislation on privacy, embassy of france in washington (dec. 2, 2007), http://ambafrance-us.org/ spip.php?article640 [http://perma.cc/n7zk-vjsc]. 159 id. 2016 535 the right to be forgotten: applying european privacy law to american electronic health records should provide more specific requirements on the level of transparency between covered entities and individual patients when collecting data. more transparency would give patients a better opportunity to make an informed decision. step three: adopt comparable measures listed in the eu data protection directive. the directive applies to non-eu companies as seen in google spain160 and, since united states’ companies are already exposed to the right, a transition would not be that difficult.161 legislation should place the protection of data and the free access of information on a level playing field.162 the united states should adopt a right of erasure that ensures health information no longer relevant to an individual will be removed from certain domains similar to the right found in the proposed european directive.163 for examples, doctors who contracted the ebola virus while working in west africa and returned home to be cured will not have their reputation tarnished by the information remaining on the internet. data becomes susceptible to exposure when it reaches a digital form, this liquidity allows for quick travel among thousands of people, versus one person viewing a paper record they were not supposed to see. it is my proposition that the right to erasure be tested on outdated and irrelevant internet pages and then implemented into ehrs after trial and error with a right that applies to the internet. 160 in the google spain decision, the court addressed the territorial issues of the eu data protection directive and affirmed its application to non-eu corporations collecting and storing personal data for advertisement purposes within the eu territories such as google, inc. case c-131/12, google spain sl v. agencia española de proteccion de datos, (aepd), 2013 ecli:eu:c:2014:616 (may 13, 2014), at paragraph 60-68. 161 with the proposed eu general data regulation, united states businesses will be subject to eu privacy laws, even though they are located outside of eu territories if they are collecting and storing an eu citizen’s personal data. european union imposes extraterritorial privacy obligations on u.s. businesses, thompson hine (may 16, 2014), http://www.thompsonhine.com/publications/european-union-imposesextraterritorial-privacy-obligations-on-us-businesses [http://perma.cc/z5g5-njmf]. 162 eu data protection directive, supra note 53. 163 id. 536 indiana health law review vol. 13:2 step four: incorporate into hipaa the eu’s proposal for a right to be forgotten. hipaa does not recognize a private right of action, and incorporating the eu’s proposal for a right to be forgotten would give patients’ full autonomy over their health information.164 a private right of action would provide individuals an opportunity to protect their reputation during a breach.165 the proposed right to be forgotten empowers individuals to assert greater control over their reputations and identities on the internet.166 the controversial right would grant individual citizens the ability to demand the permanent removal of personal content from the internet.167 there is an argument that this proposed right would have a negative impact “on freedom of expression and notions of privacy”168; however, such a right strengthens these freedoms by allowing revocation of certain expressions, like a painter painting over one of his pieces of artwork.169 an individual who mistakenly posts on a social media site should have the ability to permanently delete the post from the internet. similarly, it allows minors accessing the internet via social media to erase potentially reputationdestroying posts. one may ask how this right to be forgotten will apply to ehrs? the right should be applied when a patient no longer seeks care from a certain provider. if the patient has made an affirmative action to see another provider, once the ehr is passed to the new provider, then the patient should have the right to erase the ehr from the prior provider. additionally, irrelevant health information should be available to the right as well. hhs will play a vital role in determining which health information may be available.170 164 id. 165 emily adams shoor, narrowing the right to be forgotten: why the european union needs to amend the proposed data protection regulation, 39 brook. j. int’l l. 487, 489 (2014). 166 jeffrey rosen, the right to be forgotten, 64 stan. l. rev. 88 (2012). 167 shoor, supra note 168. 168 id at 487. 169 id. 170 hhs rulemaking must be done through notice and comment proceeding under the administrative procedure act. ideally this approach would allow experts to weigh in on the issue and allow hhs to 2016 537 the right to be forgotten: applying european privacy law to american electronic health records empowering patients to control their own health information may lead to better outcomes, although there is no evidence to support this proposition. another possible way to protect patient data may be through the consumer privacy bill of rights act, a draft bill proposed by the obama administration.171 as nicolas terry, a professor at indiana university robert h. mckinney school of law, states, the bill goes further than current hipaa regulations in requiring custodians to furnish a more encompassing privacy policy.172 additionally, the bill “presupposes some consent mechanism (removed from hipaa in 2002) and provides for withdrawal of consent and, in some situations, erasure.”173 the consumer privacy bill of rights is a step in the right direction for the obama administration and begins the all too important first step in the realization of a right of health data privacy mentioned within this note. b. problems with an american right to be forgotten implementation of the right to be forgotten would be a difficult, but not impossible, endeavor for the united states. the right to be forgotten would have to be a legislativelycreated right and the statute constitutionally permissible. the united states courts, legislature, and even the constitution have not given an explicit right to privacy for electronic health data. while the european union’s right to make a rule that is as well tested as possible. see administrative procedure act, 5 u.s.c. § 553 (2015). 171 nicolas terry, should health lawyers pay attention to the administration’s privacy bill?, health affairs (mar. 13, 2015), http://m.healthaffairs.org/blog/2015/03/13/should-health-lawyers-payattention-to-the-administrations-privacy-bill/ [http://perma.cc/ca3uabx3] (discussing the consumer privacy bill of rights act and its potential application to the health care industry). 172 id. 173 id. professor terry illustrates the difficulty in the united states allowing data minimization in the health care industry. currently, we operate under a system that supports the transferability of data. professor terry argues that the greatest impact will be felt by “big data brokers and [health] app developers.” 538 indiana health law review vol. 13:2 be forgotten stays within the realm of data privacy174 and not health information, the united states form should encompass both. furthermore, the united states’ courts have not recognized a right of privacy for health information that the right to be forgotten would require.175 a health information right of privacy would grant individuals autonomy over what health information appears on the internet and what nontreatment information is in the health records. bipartisanship support in the united states legislature has proven difficult to attain. thus, getting such a right passed through both houses and signed into law by the president may prove an immense challenge. once passed, the implementation could take years before the right is fully available to individuals.176 first amendment proponents will attack the right as a way to diminish the freedom of speech and expression.177 the eu has not been immune from free speech arguments against their right to be forgotten. the defense was raised after the european court of justice issued the google spain decision.178 the eu saw two very different principles collide: the right of privacy and the freedom of speech.179 it reconciled the two rights by limiting removal of information to “inaccurate, inadequate, or no longer relevant” personal information.180 however, the european court of justice failed to provide definitions to these terms.181 the united 174 general data protection regulation, supra note 68. 175 whalen v. roe, 429 u.s. 589, 605-06 (1977). 176 joel reidenberg, restoring american’s privacy in electronic commerce, 14 berkeley tech. l.j. 771, 787 (1999). 177 see shoor, supra note 164, at 498-500. 178 luciano floridi, should you have the right to be forgotten on google? nationally, yes. globally, no., huffington post, http://www.huffingtonpost.com/luciano-floridi/google-right-to-beforgotten_b_6624626.html [http://perma.cc/2tgk-znmt] (last updated apr. 7, 2015). 179 id. 180 id. 181 opponents of the decision are worried about its effects on freedom of expression, especially in the context of journalistic and artistic expression. they continue by pointing out that the court failed to explain the right to be forgotten’s application to the other fundamental rights, such as the freedom of expression. eleni frantziou, further http://dx.doi.org/doi:10.15779/z38c388 2016 539 the right to be forgotten: applying european privacy law to american electronic health records states constitution protects the freedom of speech, 182 which poses an even larger hurdle for a statutorily created right to electronic data privacy. however, congress may pass a constitutionally permissible statute allowing a right to electronic data privacy if it is similarly narrowly defined and does not infringe on the freedom of speech.183 a right to electronic data privacy could look similar to the common law doctrine of informed consent. informed consent provides that physicians will make a guideline as to what information the patient needs to make a reasonable decision regarding their treatment.184 a right to electronic data privacy will require the provider to disclose to the patient where and what data will be electronically transferred. similar to informed consent, it will require the patient to agree to the transfer of the data between “covered entities” and “business associates.”185 once implemented, hhs will have to decide which parts of a patient’s health information will be available to be “forgotten.” any information that is not relative to a current treatment and anything past six years should be subject to the right. hhs will determine which information is available by a notice and comment rulemaking procedure.186 hipaa holds a similar retention period for its policies and procedures.187 for example, someone with high blood pressure would not be able to erase any data related to the patient’s heart health. however, a patient who was cured of an ailment or a symptom should be able to have that developments in the right to be forgotten: the european court of justice’s judgment in case c-131/12, google spain, sl, google inc. v agencia espanola de proteccion de datos, 14 hum. rts. l. rev. 761, 767 (2014). 182 u.s. const. amend. i. 183 see floridi, supra note 177. 184 see generally canterbury v. spence, 464 f.2d 772 (1972). 185 id. 186 this procedure could include looking at allowing patients to revoke all consent for providers to collect and store their information, or it could include patients being able to remove certain ailments such as a sprained ankle that experts feel may not affect other ailments. administrative procedure act, 5 u.s.c. § 553 (2015). 187 health insurance portability and accountability act of 1996 (hipaa), pub. l. no. 104-191, 110 stat. 1936 (1996) (codified as amended in various sections of 42 u.s.c.). http://dx.doi.org/10.1093/hrlr/ngu033 540 indiana health law review vol. 13:2 information forgotten until the patient is ready to disclose it. merriam-webster dictionary defines cure as “recovery or relief from a disease,”188 and symptom as “a change in the body or mind which indicates that a disease is present.”189 however, the hhs department will likely need to create a board with members appointed by the president to determine which symptoms and ailments will be available for removal. the president has the power of appointment under article ii of the constitution190 to appoint leading minds in the medical field to the board. community insight from the notice and comment requirements under the administrative procedure act could be a valuable tool in determining the ailments and diseases to be subject to the right.191 further, the patient will have the ability to revoke consent to the transmission of their information at any time in the health care delivery system. every company with access to protected information will be subject to hipaa right to be forgotten, and must relay notification of their access to such data to each individual. push back from “covered entities” and “business associates” in the health care industry will be significant. the health care industry will likely argue that the past legislation has pushed them to have electronic health records be more accessible, whereas this would attempt to restrict the free flow of records.192 providing a private right of action for violations of the right to be forgotten and subsequent data breaches would place added liability on these health providers.193 this will likely lead to an increase in health care costs in the u.s. however, the higher costs to a strengthened hipaa will ideally reflect in lower fraud costs. once the 188 cure definition, merriam-webster dictionary, http:// www.merriam-webster.com/dictionary/cure [http://perma.cc/59l5-3lfb] (last visited feb. 7, 2016). 189 symptom definition, merriam-webster dictionary, http:// www.merriam-webster.com/dictionary/symptom [http://perma.cc/yru8zmw6] (last visited feb. 7, 2016). 190 u.s. const. art. ii, § 2. 191 administrative procedure act, 5 u.s.c. § 553 (2015). 192 health insurance portability and accountability act of 1996 (hipaa), pub. l. no. 104-191, 110 stat. 1936 (1996) (codified as amended in various sections of 42 u.s.c.). 193 shoor, supra note 164 at 491. 2016 541 the right to be forgotten: applying european privacy law to american electronic health records system is in effect, then costs will likely fall, and fraud costs will remain at a low rate. another provider criticism will point to the lack of patient awareness or patients not being informed enough to make reasonable decisions on what information to erase.194 while this may always be the case with some patients, educating the population may be able to increase patient awareness and use of the right. the eu model for the right of erasure and right to be forgotten places the onus on the consumer (in this case the patient) to make an informed decision.195 this could prove difficult for an american populace that has historically been far removed from the health delivery system. patients can become quickly overwhelmed when asked to make a medical decision on their own,196 however, a push for more health care education regarding price and options should be available. patients also rarely know the prices of the treatment they receive beforehand. this lack of knowledge is largely due to the third party payer system the united states has adopted. today, patients under hmos have very little say in their own health care. the hmos provide a list of physicians and networks in which the patient may choose.197 the average patient will have little choice but to accept what the hmos have already decided for them.198 the cost of health care will continue to rise under such a system, because the patient is far removed from the payment process. c. solutions first for such a plan to work, the legislature must recognize a right to electronic data privacy of the individual. 194 reed abelson & julie creswell, report finds more flaws in digitizing patient records, n.y. times (jan. 8, 2014) available at http://www.nytimes.com/2014/01/08/business/report-finds-more-flawsin-digitizing-patient-files.html?_r=0 [http://perm.cc/ sjk4-9j4w]. 195 general data protection regulation, supra note 68. 196 jan hoffman, awash in information, patients face a lonely, uncertain road, n.y. times (aug. 14, 2005), available at http://www.nytimes.com/2005/08/14/health/14patient.html?pagewanted =all&module=search&mabreward=relbias%3aw%2c%7b%222%22%3 a%22ri%3a14%22%7d [http://perma.cc/v84d-6v26]. 197 id. 198 id. http://www.nytimes.com/2005/08/14/health/14patient.html?pagewanted=all&module=search&mabreward=relbias%3aw%2c%7b%222%22%3a%22ri%3a14%22%7d http://www.nytimes.com/2005/08/14/health/14patient.html?pagewanted=all&module=search&mabreward=relbias%3aw%2c%7b%222%22%3a%22ri%3a14%22%7d http://www.nytimes.com/2005/08/14/health/14patient.html?pagewanted=all&module=search&mabreward=relbias%3aw%2c%7b%222%22%3a%22ri%3a14%22%7d 542 indiana health law review vol. 13:2 as a society, we must continue to push for greater data privacy rights. the right to electronic data privacy encompasses the requirement of consent for nontreatmentrelated information in a patient file and the removal of articles and health-related posts on social media. such a right should be granted to all individuals. a right to electronic data privacy allows individuals autonomy over what information is disclosed to the public rather than third party corporations.199 second, the aca’s push for a national electronic health records system must be realized.200 this would improve the accessibility, effectiveness and security of electronic health records. it would also allow for easy removal of unnecessary information from patient records.201 for example, a patient who removes consent to a provider holding nontreatment related information such as the patient’s birthdate or social security number. once the patient pays his or her bill for the services provided, the patient will have the opportunity to remove that information from their file. in this way, the patient is afforded some protection in case of a data breach. under the hitech act, congress provided for billions of dollars in incentives for physicians and hospitals to move to electronic health records.202 however, with vast amounts of health care providers’ records not on the same system, the easy flow of information from one system to another has proven to be difficult.203 further, congress failed to understand how valuable medical information was to hackers and identity thieves. networks are not protected nor compatible to move information.204 for security to properly 199 shoor, supra note 164. 200 key features of the affordable care act by year, u.s. dep’t health & human servs., http://www.hhs.gov/healthcare/facts-andfeatures/key-features-of-aca-by-year/index.html [http://perma.cc/23s6umyx] (last updated aug. 13, 2015). 201 see abelson & creswell, supra note 194. 202 42 u.s.c. § 300jj-31 (2016). 203 julie creswell, doctors find barriers to sharing digital medical records, n.y. times, (sept. 30, 2014)http:// www.nytimes.com/2014/10/01/business/digital-medical-records-becomecommon-but-sharing-remains-challenging.html [http://perma.cc/6jgrynha]. 204 see id. 2016 543 the right to be forgotten: applying european privacy law to american electronic health records protect health records, the exchange system must be properly tested and run smoothly. employees operating the system must be adequately trained, as the most common form of data breach is employee related.205 employee breaches include lost or stolen computer equipment and “unintentional employee action.”206 even though rigorous employee training accidents will still occur, the government can mitigate and limit the number of accidents. in britain, they attempted a similar national health electronic records system, but it failed.207 british parliament attempted to install such a system without working with health care providers.208 it appears that the current united states attempt to install a national system of electronic health records will fail without a cohesive effort by everyone involved.209 a national system of electronic health records could prove a valuable defense against hackers and medical identity thieves. for such a system to work, health care providers, legislators, and electronic health tech companies would have to work hand in hand. otherwise, electronic health records will continue to have problems in exchanges. there needs to be more transparency in the health care system. patients are disconnected from the health care system.210 patients have limited autonomy outside of choosing whether or not to adhere to a treatment plan.211 patients are not given enough information to determine which provider to attend or what procedure is most effective.212 along with needing more information on data privacy, the american system of third party payers leaves many patients unaware of treatment costs. data regarding 205 bendix, supra note 42. 206 id. 207 steve lohr, lessons from britain’s health information technology fiasco, n.y. times bits blog (sept. 27, 2011, 7:40 am) http:// bits.blogs.nytimes.com/2011/09/27/lessons-from-britains-healthinformation-technology-fiasco/?module=search&mabreward=relbias% 3aw%2c%7b%222%22%3a%22ri%3a14%22%7d/ [http://perma.cc/ 58y3-4h4v]. 208 id. 209 id. 210 abelson & creswell, supra note 194. 211 hoffman, supra note 196. 212 id. 544 indiana health law review vol. 13:2 care and privacy needs to be readily available to the average layperson in order for them to make an informed decision. iv. conclusion the united states must address its lack of individual privacy protections. the united states needs to address the lack of health data privacy protections. in today’s technological world, individual privacy rights must be strengthened to the point individuals can trust providers to keep their information safe. american citizens should have the right to be forgotten rather than have their information lost or stolen. similarly, technology is constant and everywhere in today’s world, and the united states has provided limited protections to personal data. the united states must move quickly towards a legislative solution to solve the data protection issues facing the nation.213 the current eu data protection directive took five years to implement.214 the united states should adopt the eu’s right of erasure to protected health information. a right of erasure would require extensive cooperation between the two political parties to adopt such a differing stance on privacy rights.215 a right of erasure would allow patients complete control over the transmission of their information, along with the ability of patients to revoke consent to providers collecting and storing their information. such a right would also allow patients to erase prior treatments, ailments, and symptoms that are no longer related to the patients care. for example, after the ebola crisis, patients should not have to keep in their records retained by their health care providers that they were diagnosed with the virus. 213 reidenberg, supra note 176, at n.1. (examining surveys that show “. . . 82 % of those surveyed feel that consumers have lost all control over how companies collect and use their personal information.”). 214 id. at 787. 215 see generally terry, supra note 171. (explaining the changes under the 1015 draft bill). under the democratic obama administration, the 2015 consumer privacy bill or rights act will extend hipaa to greater protect health data, but it is yet to be passed in a republican-controlled congress. 2016 545 the right to be forgotten: applying european privacy law to american electronic health records kaci hickox returned from west africa aiding the nations stricken most severely by the ebola virus.216 upon her return and an elevated temperature at the airport, hickox was quarantined by airport officials and required to stay home for a 21-day period.217 she engaged in a public fight with maine officials over whether her travel after the 21-day monitoring period should be restricted.218 even though she won, her name will remain on the internet for years to come. patients like kaci hickox should have the right to be forgotten. the obama administration’s consumer privacy bill, or rights act, is an important first step for the united states toward a right to be forgotten. data privacy is increasingly becoming a major issue in the both political and economic spheres of the country.219 it is important to solidify the right to health data privacy to protect against the ever-present threat of cybercriminals. imagine once more jane doe waking to a breaking story on the news that her health insurance provider’s system was the victim of a cyberattack. however, jane rests easy, because she can exercise her right of erasure and her right to be forgotten, and her highly sensitive health data and private information may be removed with a click of a button. these rights place the power to access, collect, and store this information where it should be, in the individual’s hands. the health care industry has continually failed to protect individuals’ information, and it is time the united states has addressed the issue with stronger protections for individual data privacy. 216 dana ford, ebola nurse kaci hickox, boyfriend plan to leave maine town, cnn (nov. 10, 2014, 11:30 am), http:// www.cnn.com/2014/11/09/health/ebola-nurse/ [http://perma.cc/4c5xtgnm]. 217 id. 218 id. 219 see ponemon inst. llc, supra note 31, at 1 (according to the ponemon institute study, a compromised file could cost a company up to $200). identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule david a. mata* i. background ................................................................. 416 ii. the rule’s interplay with the false claims act ... 418 iii. the s.d.n.y.’s faulty analysis ............................... 422 a. plain language meaning ...................................................... 422 b. the rule’s legislative development ..................................... 423 c. the rule’s plain language trumps the s.d.n.y.’s unsupported policy position ...................................................... 428 d. creating absurdity where none exists ................................ 429 iv. conclusion ............................................................... 430 on august 3, 2015, the southern district of new york (“s.d.n.y.”) issued its long-awaited opinion and order denying the defendants’ motion to dismiss the case ex rel. kane v. healthfirst, inc., et al.1 healthcare providers have waited with baited breath for a court’s first impression of the sixty day report and return rule (the “rule”). the rule is part of the affordable care act’s (“aca”) medicare and medicaid program integrity provisions which requires providers to report and return overpayments within sixty days of identification.2 issues with the law’s statutory construction have frustrated its interpretation and implementation. glaringly, the law does not define when an overpayment is “identified” yet provides definitions for the words “knowing” and “knowingly” without using them * associate, aegis compliance & ethics center, llp; ll.m., loyola university chicago school of law; j.d., tulane university law school; b.a., university of virginia. 1 kane ex rel. u.s. v. healthfirst, inc., 120 f. supp. 3d 370 (s.d.n.y. 2015). 2 42 u.s.c. § 1320a-7k(d) (2016). http://dx.doi.org/10.18060/3911.0022 416 indiana health law review vol. 13:2 elsewhere in the statute.3 the implementation of the rule hinges on the definition of “identified,” and the s.d.n.y. took the statute beyond what its language may bear in order to provide what it feels is the proper reading. i. background kane ex rel u.s. v. healthfirst inc. ultimately stems from a software problem.4 healthfirst, “a private non-profit health insurance program,” administers a medicaid managed care program whose beneficiaries receive services at three new york hospitals operated by continuum health partners.5 this managed care program operates on what is called a capitation model, where the new york state department of health (“doh”) provides a monthly payment for the beneficiaries as opposed to the fee-for-service model.6 normally, when healthfirst sends payments to hospitals on behalf of these beneficiaries, a code is included which tells providers they may not seek out secondary payment for the services beyond co-payments from certain patients.7 continuum’s billing software erroneously translated the code as one permitting secondary payors.8 the hospitals automatically generated bills to entities such as the doh, which mistakenly paid some of these improper claims.9 in september 2010, the new york state comptroller’s office questioned continuum about the incorrect billing.10 after discovering the problem’s cause, continuum tasked relator kane with determining “which claims had been improperly billed.”11 in early february 2011, kane emailed a spreadsheet containing more than 900 claims with the erroneous code to several members of continuum’s 3 id. cms recently issued a final rule defining “identified,” discussed infra section v. 4 kane, 120 f. supp. 3d 370 at 375. 5 id. at 376. 6 id. 7 id. 8 id. 9 id. 10 id. 11 id. at 377. 2016 417 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule management.12 he indicated that further analysis was needed and that the spreadsheet gave “some insight to the magnitude of the issue.”13 continuum terminated kane’s employment four days later and allegedly “did nothing further” with kane’s analysis.14 it reimbursed the doh “for only five improperly [paid] claims.”15 the comptroller identified several further “tranches of wrongful claims, which it brought to continuum’s attention” through most of 2011 and early 2012.16 the government issued a civil investigative demand in june 2012 seeking more information on the overpayments, and continuum never shared kane’s email with the comptroller.17 continuum did not fully reimburse the doh until march 2013, a little over two years from kane’s email.18 ultimately, roughly half of kane’s listed claims resulted in overpayments.19 the government alleges that kane’s email “identified” overpayments under the rule, thus triggering the countdown back in february 2011.20 the defendants filed a motion to dismiss the case on the grounds that the email did not identify overpayments, amongst other reasons.21 the court denied the motion and provided insight for its agreement that the clock began with the email.22 this article will focus on the issue of “identified” and not other portions of the order such as pleading requirements under rule 9(b). the rule provides in relevant part: (2) deadline for reporting and returning overpayments an overpayment must be reported and returned under paragraph (1) by the later of— 12 id. 13 id. 14 id. 15 id. 16 id. at 377-78. 17 id. at 378. 18 id. 19 id. 20 id. 21 id. 22 id. 418 indiana health law review vol. 13:2 (a) the date which is 60 days after the date on which the overpayment was identified… (3) enforcement any overpayment retained by a person after the deadline for reporting and returning the overpayment under paragraph (2) is an obligation (as defined in section 3729 (b)(3) of title 31) for purposes of section 3729 of such title. (4) definitions in this subsection: (a) knowing and knowingly the terms “knowing” and “knowingly” have the meaning given those terms in section 3729 (b) of title 31. (b) overpayment the term “overpayment” means any funds that a person receives or retains under subchapter xviii or xix to which the person, after applicable reconciliation, is not entitled under such subchapter.23 ii. the rule’s interplay with the false claims act a threshold question to ask when reviewing this law is what exactly does it add to the statutory lexicon? the false claims act (“fca”) already prohibits holding on to money owed to the government.24 what this law provides is a “clock.” it tells providers how long they have to report and return an overpayment before potential “reverse fca” liability attaches, where an entity is liable for failing to return money to which it is not entitled. but when does the clock start? unfortunately, a definition of “identified” was not provided. guidance on this issue is of the utmost importance for healthcare providers given the rule’s fca enforcement provision. the fca permits the government to impose hefty penalties ranging from $5,500 to $11,000 per false claim and 23 42 u.s.c. § 1320a-7k(d) (2016). 24 31 u.s.c. § 3729(a)(1)(d) (2016). 2016 419 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule up to treble total damages.25 the fca is invoked here through its “reverse” provision, which congress introduced in 1986 with amendments to the fca.26 reverse false claims occur when a person knowingly avoids, conceals, or decreases an obligation to pay the government.27 courts struggled with how to define “obligation,” with some circuits holding that an obligation could only exist through an independent legal duty to pay the government, and that simply making a false claim which could result in a penalty was not sufficient.28 these decisions frustrated the fca’s enforcement, and in early 2009 the department of justice wrote congress a letter stating that the courts “unduly narrowed the reverse false claim provision by holding or suggesting that the term obligation encompasses only a duty to pay that is fixed in all particulars, including the specific amount owed.”29 congress listened, and in april 2009 it passed the fraud enforcement and recovery act (“fera”) to combat fraud experienced during the housing crisis of 2008 and to 25 federal civil penalties inflation adjustment act of 1990, pub. l .no. 101-410, § 5(a)(3), 104 stat 890 (jan. 5, 1990). 26 james b. helmer, jr., false claims act: incentivizing integrity for 150 years for rogues, privateers, parasites, and patriots, 81 u. cin. l. rev. 1261, 1272 (2013). 27 31 u.s.c. § 3729(a)(1)(g) (2009). 28 see united states ex rel. bahrani v. conagra, inc., 465 f.3d 1189, 1195 (10th cir. 2006) (tenth circuit holding that an obligation arises from an independent legal duty and not from simply using or making a false record or statement that could result in a potential penalty); united states ex rel. bain v. ga. gulf corp., 386 f.3d 648, 658 (5th cir. 2004) (fifth circuit holding that a chemical plant did not create a reverse false claim obligation when it falsified environmental emission reports because “the mere contingent potential that such fines or penalties might be… sought and imposed does not constitute an obligation…”); united states v. q int’l courier, inc., 131 f.3d 770, 774 (8th cir. 1997) (eighth circuit holding that a courier service did not have a reverse false claims obligation for taking mail to barbados and sending it back to the united states to save on postage costs because the penalties were potential and not “a fixed sum that is immediately due.”). 29 letter from m. faith burton, acting assistant att’y gen., u.s. dep’t of justice, to sen. patrick leahy, chairman, senate comm. on the judiciary, (feb. 24, 2009) available at http://www.friedfrank.com/ files/qtam/doj%20views%20on%20section%204%20of%20fera%20(2) .pdf [perma.cc/vaj6-z668]. 420 indiana health law review vol. 13:2 strengthen the fca.30 senator patrick leahy, one of the bill’s sponsors, declared that fera “will rebuild the nation’s capacity to investigate and prosecute the mortgage and corporate frauds that have so severely undermined the economy and hurt so many working people.”31 on the senate floor, senator leahy spoke of the importance of updating the fca and called it “one of the most potent civil tools we have for rooting out waste and fraud in government.”32 reiterating the law’s focus on the housing crisis, he said the “the false claims act must quickly be corrected and clarified in order to protect from fraud the federal assistance and relief funds expended in response to our current economic crisis.”33 in the house of representatives, dan maffei of new york voiced prophetic concerns on the new reverse false claim provision’s application to the medical field.34 his speech shows that congress contemplated the provision’s effect on hospitals before deciding the changes would not unduly burden healthcare providers. his speech shows that congress contemplated the provision’s effect on hospitals before deciding the changes would not unduly burden healthcare providers. he stated, drafting language to pursue unlawful retention of an overpayment proved difficult... when we considered similar legislation in committee, i learned that hospitals, universities, and other research institutions are among various entities that function in government programs where 30 tyler robinson & roger r. clayton, rise of the “reverse” false claim & proposed rules from cms on reporting & returning overpayments, ill. ass’n def. of counsel quarterly, (jan. 9, 2014), http://www.iadtc.org/news/152147/rise-of-the-reverse-false-claim-proposed-rules-from-cms-on-reporting--returning-overpayments.htm [perma.cc/lg6q-ebpt]. 31 senate to consider leahy-grassley anti-fraud measure during wednesday’s session, off. of sen. patrick leahy (apr. 22, 2009), http://www.leahy.senate.gov/press/senate-to-consider-leahy-grassleyanti-fraud-measure-during-wednesdays-session [perma.cc/nda8zhpr]. 32 111 cong. rec. s1682 (feb. 5, 2009) (statement of sen. leahy). 33 id. 34 111 cong. rec. h5268 (may 6, 2009) (statement of h.r. maffei). 2016 421 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule the program rules do require those entities to account for overpayments . . . . . . . a new subsection of the false claims act will not impose liability for the mere retention of an overpayment over the course of the reconciliation period. rather, the new subsection would require proof of a knowing false record or statement, of knowing concealment, or of knowing and improper acts to avoid or decrease an obligation to pay money to the government. so, if a person or entity receives an overpayment from the united states and fails to return it immediately and instead takes steps to return the overpayment through an applicable reconciliation process, then liability would not attach. however, if a person falsifies information during a reconciliation period or otherwise acts knowingly and improperly to avoid the payment, liability would attach. so it's vitally important that we pass this legislation to fight financial fraud. but it's also important that we not punish universities, hospitals, and other important research institutions when they're doing everything that they are supposed to do. we must have enforcement and also fairness.35 congress tailored the reverse false claim provision to healthcare institutions using the rule. the rule’s addition of the sixty day clock shows congress’s intent to spur providers into action to repay obligations in a timely fashion. but congress failed to shed adequate light on when a healthcare provider “identifies” an overpayment, and the s.d.n.y. has adopted the government’s position, which manifests representative maffei’s warnings of the reverse false claims provision unduly burdening healthcare providers. 35 id. 422 indiana health law review vol. 13:2 iii. the s.d.n.y.’s faulty analysis a. plain language meaning the s.d.n.y. begins its analysis with the law’s plain language, arguing that dictionaries do not resolve the questions of the meaning of “identified.”36 the court cites black’s law dictionary, which defines “identify” as “to prove the identity of.”37 merriam-webster’s dictionary defines “identify” as “to know and say who someone is or what something is,” “to find out who someone is or what something is,” and “to show who someone is or what something is.”38 the oxford dictionary offers, “to establish or indicate who or what someone or something is.”39 the court then turns to the “less prominent” collins dictionary which lists synonyms for “identify” as “ ‘recognize,’ ‘name,’ ‘pinpoint,’ ‘point out,’ and ‘spot.’”40 after listing these definitions, the court conclusorily states that “while kane did not purport to conclusively prove the identity of any overpayments – and hundreds of the claims he listed had not actually been overpaid – he did ‘recognize’ nearly five hundred claims that did in fact turn out to have been overpaid as worthy of attention.”41 this conclusion appears to be derived from the list of synonyms in the collins dictionary, conveniently ignoring the long list of definitions which give the real meaning of the word “identify.” looking through these definitions, the common thread is that something is not “identified” until someone can prove or show or what that thing is. the analysis should have ended here, and the court should have determined that kane’s email did not identify any overpayments because the email did not prove or show funds received in error. instead, the court moves on to an analysis of the rule’s legislative history to support its 36 kane ex rel. u.s. v. healthfirst, inc., 120 f. supp. 3d 370 (s.d.n.y. 2015). 37 id. at 384. 38 id. at 384-85. 39 id. at 385. 40 id. 41 id. 2016 423 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule position.42 an overview of the rule’s development runs counter to the government and court’s interpretation. b. the rule’s legislative development the senate and house both worked on separate versions of the aca for most of 2009.43 the house chairmen working together on the aca released the first house version of the health care legislation, called a “discussion draft,” on june 19, 2009.44 the purpose of this draft was to spur conversation to begin the legislative process in the house.45 the rule first appears here with the basic elements – reporting and returning overpayments – in place.46 however, this version of the rule differs from the final one in several ways. the final rule applies if “a person has received an overpayment,” whereas the discussion draft version applies if “a person knows of an overpayment.”47 the discussion draft version’s sixty day clock begins when an overpayment is “identified,” much like the final rule.48 the two versions also state that overpayments kept beyond the sixty days become obligations under the fca.49 absent from the discussion draft version is the clause tying the use of “knowing” or “knowingly” to the fca definition (the “definition clause”).50 after more hearings, the house committee leaders introduced house bill 3200, america’s affordable health choice act of 2009, on july 14, 2009.51 traditionally house 42 id. at 386. 43 john cannan, a legislative history of the affordable care act: how legislative procedure shapes legislative history, 105 law libr. j. 131, 145 (2013). 44 id. at 137. 45 id. 46 id. 47 h.r. 3200, 111th cong. at 725 (2009), available at https://www.gpo.gov/fdsys/pkg/bills-111hr3200ih/pdf/bills111hr3200ih.pdf [perma.cc/2blm-mm8e]. 48 compare h.r. 3200 with 42 u.s.c. § 1320a-7k(d)(1) (2010). 49 compare h.r. 3200 and 42 u.s.c. § 1320a-7k(d)(1) (2010) with 31 u.s.c. § 3729 (2016). 50 compare h.r. 3200 and 42 u.s.c. § 1320a-7k(d)(1) (2010) with 31 u.s.c. § 3729 (2016). 51 cannan, supra note 43, at 137-38. 424 indiana health law review vol. 13:2 bills are crafted through a process where the committee debates, amends, and then votes on whether or not to report out the bill.52 each amended version of the bill is known as a “markup” and is invaluable to a legal researcher for shedding light on amendments that were considered, debated, and discarded.53 in the case of house bill 3200, committee leadership instead drafted the bill behind closed doors and outside the markup process, leaving only its plain text as a guide.54 the house bill 3200 version of the rule altered the discussion draft version.55 it kept the opening clause that the rule applies if “a person knows of an overpayment,” but changed the sixty day countdown’s start from when the overpayment is “identified” to when “the person knows of the overpayment.”56 along with this change, the house bill 3200 version also introduced the definition clause defining “knows” as having the same meaning as “knowing and knowingly” from the fca.57 the senate finance committee also worked on a draft of the aca during this time.58 on september 16, 2009, senator baucus released his chairman’s mark of bill, called america’s healthy future act.59 undoubtedly the finance committee reviewed house bill 3200, which was released two months before their version. this senate version is written in a colloquial style, detailing the current status of the law and the proposed changes.60 it states that the 60 days providers and suppliers have to repay medicare overpayments would be modified to either 60 days after the date on which the 52 id. at 138. 53 id. 54 id. 55 america’s affordable health choices act of 2009, 111th cong., h.r.b 3200 (july 14, 2009), available at http://www.jeffhead.com/hchouseii.pdf [perma.cc/ytx8-n2ht]. 56 id. 57 id. at 727. 58 cannan, supra note 43, at 147. 59 id. 60 u.s. senate, committee on finance, america’s healthy future act of 2009, s. doc. no. 111-89 (1st sess. 2009). 2016 425 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule overpayment was made or the date the corresponding cost report is due. providers and suppliers would be required to repay any medicare or medicaid overpayment identified through an internal compliance audit.61 although it implies that the clock starts when an overpayment is made, much less identified or known, this mark was likely intended to foster discussion in anticipation of a heated legislative session and is not written in a legal manner.62 back in the house, the ways and means committee, the committee on education and labor, and the committee on energy and commerce conducted markups of house bill 3200 in july 2009 and reported them to the house floor on october 14, 2009.63 none of these markups changed the rule’s text.64 house bill 3200 ended with these three versions.65 meanwhile, the senate finance committee’s markup sessions produced senate bill 1796, reported out on october 19, 2009.66 senate bill 1796 contains the rule in essentially its final form.67 the only difference between the senate bill 1796 version and the final version, are clean-ups involving updating or clarifying internal citations such as changing a reference to “title xviii” to “subchapter xviii.”68 the senate made several changes to the house version of the rule. first, the senate changed the opening language from “if a person knows of an overpayment” to “if a person 61 id. 62 cannan, supra note 43, at 147. 63 id. at 140. 64 h.r. 3200, 111th cong. at 725 (2009), available at https://www.gpo.gov/fdsys/pkg/bills-111hr3200ih/pdf/bills111hr3200ih.pdf [perma.cc/2blm-mm8e]; h.r. rep. no. 111-299, pt. 1 (2009); h.r. rep. no. 111-299, pt. 2 (2009) (note that the markup does not explicitly list the rule but encompasses it because it says to keep division b, which contained the rule). 65 canaan, supra note 43, at 140. 66 111th cong. sen. fin. comm, s. 1796, oct. 19, 2009. 67 id. at 1355-57. 68 42 u.s.c. § 1320a-7k(d) (2010). 426 indiana health law review vol. 13:2 has received an overpayment.”69 importantly, it changed the clock’s start to “the date on which the overpayment was identified” instead of “the date the person knows of the overpayment.”70 the most striking and confounding change that this senate version produced from house bill 3200 is that it removed all forms of the word “know” from the statute’s text. however, it kept the definition clause and even updated it to now read “the terms ‘knowing’ and ‘knowingly’” instead of “the term ‘knows.’”71 a summary of the rule’s development is as follows: 69 compare 111th cong. house ways and means comm., h.r. 3200, (july 19, 2009), with 111th cong. sen. fin. comm., s. 1796, (oct. 19, 2009). 70 compare 111th cong. house ways and means comm., h.r. 3200, (july 19, 2009), with 111th cong. sen. fin. comm., s. 1796, (oct. 19, 2009). 71 compare 111th cong. house ways and means comm., h.r. 3200, (july 19, 2009), with 111th cong. sen. fin. comm., s. 1796, (oct. 19, 2009). 2016 427 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule discussion draft house bill 3200 senate bill 1796 opening if a person knows of an overpayment if a person knows of an overpayment if a person has received an overpayment start of clock the date that is 60 days from the date the overpayment is identified the date that is 60 days after the date the person knows of the overpayment the date which is 60 days after the date on which the overpayment was identified definition clause n/a the term ‘knows’ has the meaning given the terms ‘knowing’ and ‘knowingly’ in section 3729(b) of title 31 of the united states code. the terms ‘knowing’ and ‘knowingly’ have the meaning given those terms in section 3729(b) of title 31 of the united states code.72 after a shorter review of the rule’s legislative history, the s.d.n.y. acknowledged that congress may have intended to impose a higher burden than the fca knowing standard given its rejection of “knows” for “identified.”73 yet the court also states that “it is equally plausible that congress included the definitions of ‘knowing’ and ‘knowingly’ within the aca’s report and return provision in order to indicate 72 compare 111th cong., discussion draft, (june 19, 2009), available at https://web.archive.org/web/20090624235405/http:/waysandmeans. house.gov/media/pdf/111/hrdraft1xml.pdf [perma.cc/mxm9-pqd2]; with h.r. 3200, 111th cong. (jul. 14, 2009); as compared with 1s. res. 1796, (oct. 19, 2009). 73 kane ex rel. u.s. v. healthfirst, inc., 120 f. supp. 3d 370, 386 (s.d.n.y. 2015). 428 indiana health law review vol. 13:2 that the fca’s knowledge standard should apply to the determination of when an overpayment is deemed ‘identified.’”74 the legislative history counters this assertion as it demonstrates that congress is capable of providing definitions to words when it so intends. c. the rule’s plain language trumps the s.d.n.y.’s unsupported policy position admittedly, the court does not directly use the definition clause to provide its reasoning, although its conclusion comports with the fca knowing standard. instead, the court resorts to a general “policy” argument.75 as recently seen in king v. burwell, policy can play a strong role in the interpretation of the aca.76 the court harkens back to the reasoning behind fera’s passage. congress updated the term “obligation” to include “an established duty, whether or not fixed, arising… from the retention of an overpayment.”77 therefore, “congress intended for fca liability to attach in circumstances where, as here, there is an established duty to pay money to the government, even if the precise amount due has yet to be determined.”78 this logic ignores the fact that “overpayment” and “obligation” are not used synonymously in the rule. this nuance is crucial to understanding why the s.d.n.y.’s position falls flat on its face, and why the definition of the word “overpayment” is just as critical as the word “identified.” the clock starts with the identification of an “overpayment.”79 an overpayment is defined as “any funds that a person receives or retains … to which the person, 74 id. at 387. 75 id. at 23. 76 king v. burwell, 135 s. ct. 2480, 2496 (u.s. 2015) (stating that a policy goal of the affordable care act is “to improve health insurance markets,” therefore “[i]f at all possible, we must interpret the act in a way that is consistent” with this goal). notably, this case cited numerous examples of policy positions to support its claim, whereas here the record of policy statements on the rule is barren. 77 kane ex rel. u.s., 120 f. supp. 3d 370, 388 (s.d.n.y. 2015) (emphasis in original). 78 id. at 388. 79 42 u.s.c. § 1320a-7k(d) (2016). 2016 429 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule after applicable reconciliation, is not entitled.”80 an overpayment becomes a reverse false claims obligation after sixty days.81 therefore, an overpayment cannot exist unless funds have been received and retained, and an obligation cannot exist without an overpayment. how, then, can kane’s spreadsheet identify any overpayments when the list does not state the corresponding funds received for each claim? the clear answer is that it cannot. by the court’s own admission, “approximately half of the claims listed therein were never actually overpaid.”82 if no excess funds were received, there was no overpayment, and no overpayment means no obligation. there is no dispute that an exact dollar amount need not be pre-determined for an obligation to exist. but by the same token, an obligation under the rule cannot exist when the existence of an overpayment is unknown. d. creating absurdity where none exists the court makes the case that its interpretation avoids the “absurdity” that comes with the plain language meaning of the rule.83 this reading, the court argues, “would make it all but impossible to enforce the reverse false claims provision of the fca in the arena of healthcare fraud” because providers would intentionally bury their heads in the sand.84 without holding that kane’s email identified overpayments, “there will be no recourse for the government when providers behave as continuum allegedly behaved here.”85 one would be hard pressed to find a provider that argues that it is allowed to hold onto overpayments, given that the rule did not replace the fca. retaining funds to which the person is not entitled is still an illegal act. when viewed with the realities of a provider’s internal medicare and medicaid audit process, the rule is not absurd. the defense described the process to the court’s deaf ears, noting that once a provider is made aware of a potential 80 id. at § 1320a-7k(d)(4)(b). 81 see id. at § 1320a-7k(d)(2). 82 kane ex rel. u.s., 120 f. supp. 3d 370, 388 (s.d.n.y. 2015). 83 id. at 389. 84 id. at 390. 85 id. 430 indiana health law review vol. 13:2 overpayment it must pull and review the relevant medical records, discuss the cases with the physicians, consult with coding staff and possibly counsel, and then expand the scope of the audit if the initial sample reveals overpayments.86 the provider then makes arrangements to return the overpayments which may involve identifying every specific claim that resulted in an overpayment.87 applied as written, the rule gives providers a hard deadline of sixty days to return the overpayments that are identified once funds are matched to claims in the audit process. this would ensure that overpayments continuously and timely roll to medicare administrative contractors while the provider conducts the audit. this standard would establish a level of predictability for providers and their medicare administrative contractors for the backwards flow of money. the “absurdity” the court warns will consume the industry is not apparent. iv. conclusion the court stretches the language of the statute beyond what it can bear in order to satisfy the government’s hindsight-driven argument. it is disheartening that the court did not take the opportunity to interpret the law as it is written. such a holding, if not what the legislature intended, would spur congress to reexamine the poorlywritten statute. hearings on the rule attended by compliance officers and other deep in the trenches would teach congress the operations of a provider’s reimbursement process. returning medicare and medicaid overpayments is an extremely important policy goal for the office of inspector general and the department of justice. those charged with protecting the medicare trust fund must have the proper tools to fulfill their mission, and conscripting providers to timely return overpayments will free the government’s already thin resources. but the enforcers must stay within the law. the government rightfully argues that failing to 86 id. at 388-389 (quoting mem. of law in support of defendant’s mot. to dismiss gov’t. compl. at 10–11, kane v. healthfirst, inc., no. 11 civ. 2325 (er) (s.d.n.y. sept. 22, 2014)). 87 id. at 389. 2016 431 identifying schrödinger's cat: ex rel. kane and the future of the sixty day report and return rule return the overpayment by day sixty-one does not automatically mean that the provider will be hauled to court, stating at a pre-motion conference that if “the hospital is diligently working on the claims and it’s on the sixty-first day . . . the government wouldn’t be bringing that kind of a claim.”88 as shown above, it is questionable if the government could even bring a claim if no overpayment exists. but assuming the government’s position prevails, is constantly hanging the sword of damocles over the heads of the nation’s hospitals a good policy goal? by ensuring that healthcare providers will be in an eternal state of panic, the s.d.n.y. is securing employment for audit consulting firms for years to come. hospitals that do not have the finances to hire a legion of cpas or consultants must either fold or rely on the mercy of government attorneys such as the one who promised they “wouldn’t be bringing that kind of a claim.”89 on february 12, 2016, the centers for medicare & medicaid services (cms) released its final rule on the 60 day report and return rule’s applicability to medicare parts a and b.90 relevant to this discussion, the final rule states that an overpayment is “identified” when the person “has, or should have through the exercise of reasonable diligence, determined that the person received an overpayment and quantified the amount of the overpayment.” 91 this is a welcome departure from using the false claims act knowing standard. however, only through future enforcement will we have a clearer picture of what this test means. the kane statutory analysis remains relevant in the event that the cms final rule fails to withstand judicial scrutiny. going forward, providers will operate under the “reasonable diligence” test. cms states that “reasonable diligence” captures both proactive and reactive solutions including timely investigations in response to credible 88 id. at 389-90 (quoting transcript of record at 22:8-12, kane v. healthfirst, inc., no. 11 civ. 2325 (er) (s.d.n.y. sept. 5, 2014). 89 id. 90 medicare program; reporting and returning of overpayments, 81 fed. reg. 7654 (feb. 12, 2016) (to be codified at 42 c.f.r. pts. 401 and 405). 91 42 c.f.r. § 401.305 (2016). 432 indiana health law review vol. 13:2 information of a potential overpayment.92 applied to ex rel kane, the defendants would likely run afoul of exercising “reasonable diligence” given that it took more than two years to repay the full amount and only after repeated requests for information. despite cms’s improvements, the statute’s sixty day time limit will continue to weigh on the nation’s healthcare providers. the law will likely produce its intended effect to spur proactive compliance departments, but the price may outweigh its benefits. perhaps instead of the “report and return rule,” the rule should be the “report then return rule” with the clock’s length determined by the scope of the potential overpayment. were this the rule when continuum received kane’s email, continuum could have reported the potential overpayment to the government. the government would have then determined the amount of time to return any identified overpayments based on the number of questionable claims and possible dollar amount. the final rule allows for extended repayments under the existing extended repayment schedule program, but a provider must show financial hardship in terms of repaying an identified overpayment and not because of the demands of internal investigations.93 with the hard wall of sixty days, compliance departments will need to hire and train enough employees to respond in full force to even the slightest scent of smoke. these costs will be passed on to taxpayers and patients through increased hospital charges until congress takes the initiative to amend the rule to reflect reality. 92 medicare program; reporting and returning of overpayments, 81 fed. reg. 7661. 93 medicare program; reporting and returning of overpayments, 81 fed. reg. at 7679, 7684. regulating the marketing of foods to minors steven r. salbu* i. introduction the world is facing nutrition challenges that pit individual rights against public health. should individual rights always be paramount, or should we sometimes sacrifice unfettered commercial freedom in the interest of the public good? this article examines one pressing public health issue: should we regulate food marketing in the interest of good diet and nutrition for minors? the issue has become a critical one as poor nutrition and obesity among minors increasingly threaten their health.1 adverse outcomes from childhood obesity include type-2 diabetes, metabolic syndrome, blount’s disease, dyslipidemia, hypertension, left ventricular hypertrophy, atherosclerosis, depression, poor quality of life, pseudotumor cerebri, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, obstructive sleep apnea, renal proteinuria, and exacerbation of asthma.2 particularly troubling are the growing incidence of type-2 diabetes among minors, disproportionately affecting minority groups.3 while regulatory protection of minors does not seem controversial, such intervention reflects a more expansive notion of public health than was originally embraced in the united states. early conceptions of public health were narrow, addressing communicable diseases, sanitation, and safety.4 over the years, the notion of public health has broadened, encompassing “what we, as a society, do collectively to assure the conditions for people to be healthy.”5 these narrow and broad conceptions of public health bring with them the question, should public health initiatives be limited to the protection of individuals from publicly generated perils? or should public health also aim to improve the wellbeing of the population more broadly, even when the risk is subject to individual personal choices, as in the case of diet and nutrition? by publicly generated perils, i am referring to the health risks one faces from * professor and cecil b. day chair in law and ethics, georgia institute of technology. b.a., hofstra university; m.a., dartmouth college; j.d., college of william & mary; m.a., ph.d., the wharton school of the university of pennsylvania. 1. see stephen r. daniels et al., overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment, 111 circulation 1999, 1999 (2005). 2. id. at 2002. 3. see dana dabelea et al., prevalence of type i and type ii diabetes among children and adolescents from 2001 to 2009, 311 jama 1778, 1779 (2014) (“type 2 diabetes is increasingly diagnosed in youth and now accounts for 20% to 50% of new-onset diabetes case patients, disproportionately affecting minority race/ethnic groups. although few longitudinal studies have been conducted, it has been suggested that the increase in type 2 diabetes in youth is a result of an increase in the frequency of obesity in pediatric populations.”). 4. lawrence o. gostin & james g. hodge, jr., the public health improvement process in alaska: toward a model public health law, 17 alaska l. rev. 77, 84 (2000). 5. comm. for the study of the future of pub. health, the future of public health 19 (1988). 302 indiana health law review [vol. 20:301 our exposure to others as well as their behaviors. for example, a person catches a communicable disease from an infected person. similarly, sanitation and safetyrelated health risks often are created by, and under the control of, persons other than the individuals being protected, and therefore have been readily subject to public health controls. human waste disposal can generate disease that public health initiatives such as sewage and garbage treatment aim to counter. smokers generate second-hand smoke, threatening the health of others around them,6 so that regulation of smoking fits comfortably in the framework of counteracting publicly generated perils. conversely, the dietary habits of minors do not create a direct health threat to those around them,7 and they are usually considered to be the choice of the individual and the individual’s family.8 regulation to protect minors from questionable food marketing practices seeks to protect children who, while subject to parental guidance and control, nonetheless voluntarily consume the food they eat. it goes beyond the original conception of public health—it aims to protect minors and their families from their own consumption choices, rather than from externally created dangers like public sewage, over which they have no control.9 such expansive public health regulation is susceptible to critiques of invading personal freedom and government overreaching.10 nutrition and diet are examples which harvey identifies as part of the “new frontier” of public health interventions that are prone to public resistance.11 notwithstanding criticism, the notion of public health initiatives has expanded, at least among academics in the field, to include protecting us from our own individual actions, decisions, and choices. the association of schools & programs of public health lists a very broad range of areas that are now included 6. see health effects of secondhand smoke, ctr. for disease control & prevention, https://www.cdc.gov/tobacco/secondhand-smoke/health.html [https://perma.cc/q9rg-mufc] (last updated nov. 1, 2022). 7. children with poor diets are likely to suffer, but they do not generate health threats to their neighbors in the form of something analogous to disease-breeding garbage or second-hand smoke. 8. the conception of dietary decisions as individual choices has limitations. first, i mention families because food choices among children are directly shared by the child and the child’s guardians and providers, who purchase and provide meals. second, many believe that individual dietary choices are affected by a wide array of external factors, anything from chemicals and pesticides, which may affect hormones related to hunger and satiety, to corporate and school practices and decisions that influence what children eat. 9. laws and regulations already protect minors in extreme cases should their own parents be grossly neglectful in guarding children’s basic welfare. parents can lose custody of their own children when the well-being of those children is endangered. in the absence of dangerously irresponsible parenting, our culture in the u.s. tends to defer to parental prerogative in childrearing, emphasizing personal, individual freedoms over government intervention. 10. see infra notes 129-33 and accompanying text. 11. hosea h. harvey, nudging the public health: the political psychology of public health law intervention, 65 depaul l. rev. 57, 67 (2015). 2023] regulating the marketing of food to minors 303 in the expanded conception of the term.12 for better or worse, an examination of the listed categories indicates that, at least in academic theory, the field of public health has expanded to cover all conceivable areas related to the health of the public in general.13 to summarize, the earliest areas of public health policy—communicable disease, sanitation, and safety14—are less controversial drivers of governmental and social interventions, because all three can be framed as serious external threats to individuals that, if not managed, can cause harm, injury, or death. as perils created by others, they are persuasively and easily framed as the kinds of harms against which the laws have always sought to protect innocent victims. we tend to be most receptive to legal and regulatory protections in these kinds of situations, where behavior or activity beyond our individual control threatens us.15 this article explores the notion of a more aggressive, controversial class of regulatory and social policy public health initiatives aimed at changing what and how we eat. it recommends areas of government regulation, and other areas to be left to industry self-regulation. ii. nutrition as an increasingly troublesome public health issue food can be classified as either “core” or “non-core” based on overall nutritional value.16 core foods have essential nutrients; non-core foods are 12. all areas of study, this is pub. health, https://www.aspph.org/study/all-areas-of-study/ [https://perma.cc/ww5z-lqlp] (last visited mar. 19, 2023). 13. see id. these listed categories are aging, biomedical lab sciences, chronic disease, clinical research, communication sciences and disorders, community health, dental public health, environmental health, epidemiology, exercise science, food safety, genetics, global health, health administration, health economics/ finance, health education/behavioral sciences, health law, health promotion and communications, health services research, immunology, infectious diseases, informatics, injury/violence, management and health policy, maternal and child health, mental health, minority health and health disparities, multicultural studies, neuroscience, nutrition/public health nutrition, occupational health/industrial hygiene, parasitology, population and reproductive health, population sciences, preparedness response and recovery, public health ethics, public health leadership, public health medicine, public health policy & practice, risk assessment, social determinants of health, substance use/harm reduction, toxicology, tropical medicine, veterinary public health, and women’s health. 14. see supra note 4 and accompanying text. 15. regulations to protect data privacy are a good example of this. discussion of such regulatory efforts frequently refers to the need to protect individuals from incursions by outsiders. protection of individuals from privacy incursions by drone operators is just one subcategory. for discussion of this example, see toban platt, the drone wars: the need for federal protection of individual privacy, 13 wash. j. l. tech. & arts 27, 27 (2017). 16. zoi toumpakari et al., adolescents’ non-core food intake: a description of what, where, and with whom adolescents consume non-core foods, 19 pub. health nutrition 1645, 1645 (2016). https://www.aspph.org/study/all-areas-of-study/ 304 indiana health law review [vol. 20:301 considered surplus to nutritional requirements and are high in fat and sugar.17 while “surplus” may sound benign, it is not—foods that are high in bad fats and sugar and low in nutrients contribute to poor health.18 non-core foods have been found to comprise roughly half of the total fat and sugar in the diets of minors aged two through eighteen, and the proportion increases over the course of that age range.19 according to the u.s. healthful food council, “american adults on average purchase meals or snacks from fast[]food restaurants almost six times a week, and close to a third of children eat fast food every single day.”20 high intake of the non-nutritious foods often sold by fast food restaurants has been linked to increasing childhood obesity and declining childhood health and fitness.21 the incidence of childhood and adolescent overweight has been rising,22 and obesity has been linked to debilitating diseases like heart disease, type-2 diabetes, and cancer,23 as well as hypertension, arthritis, alzheimer’s disease, dementia, and infant mortality.24 obesity also is associated with “significant increases in morbidity and mortality from covid-19.”25 given that risks of death from covid-19 rise very substantially with age,26 these issues strongly affect adults 17. id. 18. see adam drewnowski, commentary, concept of a nutritious food: toward a nutrient density score, 82 am. j. clinical nutrition 721, 721 (2005) (“rising rates of obesity and type 2 diabetes in the united states continue to be linked to a growing consumption of refined grains (1), added sugars (2), and added fats (3).”). 19. see toumpakari et al., supra note 16. 20. joseph higgins, comment, everything is bigger in texas: the growing problem of childhood obesity in texas and how to combat it, 17 tex. tech. admin. l.j. 303, 307 (2016) (quoting press release, united nations int’l child. emergency fund, poor diets damaging children’s health worldwide, warns unicef (oct. 8, 2019), https://www.unicef.org/eca/pressreleases/poor-diets-damaging-childrens-health-worldwide-warns-unicef) [https://perma.cc/n5mb32ue]. 21. see press release, united nations int’l children’s emergency fund, poor diets damaging children’s health worldwide, warns unicef (oct. 8, 2019), https://www.unicef. org/eca/press-releases/poor-diets-damaging-childrens-health-worldwide-warns-unicef [https://perma.cc/n5mb-32ue] (noting one-third of children under five are either undernourished or overweight, and attributing their declining health and growing obesity in part to growing access to fast food and sweetened drinks). 22. richard p. troiano et al., overweight prevalence and trends for children and adolescents, 149 arch. ch. pediatric adolescence med. 1085 (1995). 23. weight problems take a hefty toll on body and mind, harv. t.h. chan. sch. pub. health, https://www.hsph.harvard.edu/obesity-prevention-source/obesity-consequences/healtheffects/ [https://perma.cc/c6md-d2xv] (last visited feb. 15, 2023). 24. paul a. diller, combating obesity with a right to nutrition, 101 geo. l.j. 969, 981 (2013) (citation omitted). 25. barry m. popkin et al., individuals with obesity and covid-19: a global perspective on the epidemiology and biological relationships, 21 obesity rev. 1, 1 (2020). 26. see risk for covid-19 infection, hospitalization, and death by age group, ctr. for 2023] regulating the marketing of food to minors 305 as well as children. that said, childhood is arguably the most critical stage associated with nutrition and public health:”[o]besity in childhood causes a wide range of serious complications and increases the risk of premature illness and death later in life, raising public-health concerns.”27 moreover, children are still developing and growing, so the stakes of good nutrition to their bodies and minds are especially high.28 children are a vulnerable population: their brains and their minds have not reached full maturity and cognitive capability,29 as cortical ability becomes finetuned over time.30 and of course, children lack full autonomy and depend on the judgment and the decisions of their parents.31 while always important, nutrition issues for minors have become even more critical in recent years. children in 2023 are susceptible to a diet-related chronic disease that rarely affected them just a few decades ago: type-2 diabetes.32 rates of childhood type-2 diabetes are rising along with rates of childhood obesity.33 disease control, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigationsdiscovery/hospitalization-death-by-age.html [https://perma.cc/u3lp-9h5g] (last updated june 2, 2022) (noting that compared to the 18-29 year-old cohort, covid death rates among 50-64 year olds are 25 times higher, covid death rates among 65-74 year olds are 65 times higher, covid death rates among 75-84 year olds are 140 times higher, and covid death rates among 85-andabove-year olds are 330 times higher). 27. cara b. ebbeling et al., childhood obesity: public health crisis, common sense cure 360 lancet 473, 473 (2002). 28. see francisco j. rosales et al., understanding the role of nutrition in the brain of toddlers and preschool children: identifying and addressing methodological barriers, 12 nutritional neuroscience 190 (2009) (discussing the role of nutrition in brain development of children). 29. see id. (“the preschool years (i.e., 1-5 years of age) is a time of rapid and dramatic postnatal brain development (i.e., neural plasticity), and of fundamental acquisition of cognitive development (i.e., working memory, attention and inhibitory control).”). 30. b.j. casey et al., imaging the developing brain: what have we learned about cognitive development, 9 trends in cognitive sci. 104, 104 (2005). 31. see j.c. westman, children’s rights, parents’ prerogatives, and society’s obligations, 29 child psychiatry hum. dev. 315, 315 (1999) (“[p]arents do not need specifically defined rights. they have prerogatives that flow from the right of their children to nurturing and protective parenting. the idea of individual rights springs from the vulnerability of human beings in the face of stronger forces. the most vulnerable individuals are children.”). 32. stephen r. daniels et al., overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment, 111 circulation 1999, 2002 (2005) (“concomitant with the rise in the prevalence of overweight and the metabolic syndrome has been a dramatic increase in type 2 diabetes mellitus in youth. type 2 diabetes mellitus had been primarily a disease of adulthood; however, type 2 diabetes now occurs in adolescents typically with a bmi 30 kg/m2, a level that would be considered obese even by adult standards.”). 33. see shannon johnson, the symptoms of type 2 diabetes in children, med. news today, https://www.medicalnewstoday.com/articles/322919 [https://perma.cc/p4pu-e4p9] (last 306 indiana health law review [vol. 20:301 moreover, because childhood obesity has been linked to a higher probability of obesity in adulthood,34 the health costs can be long-lasting and cumulative.35 iii. concerns regarding marketing of junk foods to minors food industry practices contribute to children’s high intake of junk foods, as well as the declining health that results from poor eating.36 the industry recognizes children as a “major market force.”37 according to a 2012 report by the federal trade commission, food companies spent $1.79 billion marketing to children and adolescents in 2009.38 unfortunately, foods targeted to children tend to be high in calories, sugar, salt, and fat, and low in nutritional value.39 for example, cereals targeted to children are less nutritious and have higher sugar content than those targeted to adults.40 studies of promotions targeted to children identify “moderate to strong evidence that these promotions influence children’s food preferences, purchase requests, and actual consumption patterns, to the detriment of children’s diet-related health.”41 critics contend that children and adolescents deserve protection from food manufacturers that market less healthful products directly to kids.42 by the midupdated nov. 11, 2020). 34. see frank m. biro & michelle wien, childhood obesity and adult morbidities, 91 am. j. clinical nutrition 1499, 1503 (2010) (“the consequences of childhood and adolescent obesity include metabolic syndrome and type 2 diabetes in youth and in adulthood and the development of obesity in adulthood.”). 35. id. 36. see, e.g., kaye mehta et al., marketing foods to children through product packaging: prolific, unhealthy, and misleading, 15 pub. health nutrition 1763, 1763 (2012) (“there is little dispute among public health professionals that the marketing of unhealthy foods and beverages to children plays a role in the rising prevalence of childhood obesity across the globe.”). 37. mary story & simone french, food advertising and marketing directed at children and adolescents in the us, 18 int. j. behav. nutrition & physical activity 205, 205 (2004). 38. press release, fed. trade comm’n, ftc releases follow-up study detailing promotional activities, expenditures, and nutritional profiles of food marketed to children and adolescents (dec. 21, 2012), https://www.ftc.gov/news-events/press-releases/2012/12/ftc-releasesfollow-study-detailing-promotional-activities [https://perma.cc/4r6l-m6d2]. 39. jennifer l. pomeranz, extending the fantasy in the supermarket: where unhealthy food promotions meet children and how government can intervene, 9 ind. health l. rev. 117, 123 (2012). 40. hayeon song et al., marketing cereal to children: content analysis of messages on children’s and adult’s cereal packages, 38 int’l j. consumer stud. 571, 571 (2014). 41. belinda reeve & roger magnusson, regulation of food advertising to children in six jurisdictions: a framework for analyzing and improving the performance of regulatory instruments, 35 ariz. j. int’l & comp. l. 71, 74 (2018) (citation omitted). 42. see, e.g., press release, world health org. w. pac., regional action to protect children from harmful impact of food marketing and promote healthy ageing (oct. 9, 2019), https://www.who.int/westernpacific/news/detail/09-10-2019-regional-action-to-protect-children2023] regulating the marketing of food to minors 307 1970s, both the federal trade commission and activist groups such as action for children’s television became vocal in their concerns about advertising aimed at children.43 more recently, the world health organization recommended the use of “nutrient profiling” to identify foods that companies should not be allowed to market to children.44 opponents of such regulation take a freedom-based “personal choice” stance, arguing that we each are responsible for our own dietary decisions.45 a 2017 article enumerates issues regarding the marketing of foods to minors: “whether young people represent a vulnerable audience in need of protection; how marketers are reaching children in online and social networking environments; what parents, practitioners, and policy makers can do to help children contend with these messages; and what the marketing industry can teach various stakeholders about encouraging protective behaviors in young people.”46 junk food advertising directed at children;47 use of packaging graphics, toys, and prizes aimed at children;48 and product placement at children’s eye-levels in from-harmful-impact-of-food-marketing [https://perma.cc/e5ed-cvau]. 43. deborah r. john, consumer socialization of children: a retrospective look at twentyfive years of research, 26 j. consumer rsch. 183, 183 (1999). 44. world health org., nutrient profile model for the marketing of food and non-alcoholic beverages to children in the who eastern mediterranean region 5 (2017), available at https://apps.who.int/iris/bitstream/handle/10665/255260/emropub_2017_ en_19632.pdf;jsession id=596d4c45ea6158ec8ef75e338e071bac?sequence=1 [https://perma.cc/9d4q-634r]. nutrient profiling is defined as “the science of classifying or ranking foods according to their nutritional composition for reasons related to preventing disease and promoting health.” id. (quoting world health org., guiding principles and framework manual for the development or adaptation of nutrient profile models page (2019)). other organizations around the world have created their own food nutrition classification systems, and one study found them consistent with the classifications made by seven hundred nutrition professionals. see peter scarborough et al., testing nutrient profile models using data from a survey of nutrition professionals, 10 pub. health nutrition 337 (2007). 45. see andrea freeman, comment, fast food: oppression through poor nutrition, 95 cal. l. rev. 2221, 2223 (2007) (“too often, advocates of “personal choice” blame low-income people of color for their own weight issues and health crises, linking these problems to individual moral and cultural failures instead of placing the problems in the broader, historical context of longentrenched policies and practices.”). 46. matthew h. lapierre et al., the effect of advertising on children and adolescents, 140 pediatrics 152, 153 (2017). 47. see the impact of food advertising on childhood obesity, am. psych. ass’n (nov. 17, 2010), https://www.apa.org/topics/kids-media/food [https://perma.cc/m753-jak6] (“research has found strong associations between increases in advertising for non-nutritious foods and rates of childhood obesity. most children under age 6 cannot distinguish between programming and advertising and children under age 8 do not understand the persuasive intent of advertising. advertising directed at children this young is by its very nature exploitative.”). 48. see, e.g., jennifer r. otten, food marketing: using toys to market children’s meals, 308 indiana health law review [vol. 20:301 supermarkets49 all have come under scrutiny and criticism.50 the following subsections examine these practices. a. junk food advertising directed at children researchers and children’s advocates have documented harms from advertising nutritionally poor foods to children.51 a 2019 article from the american journal of preventive medicine studied whether television advertisements directed at pre-school children are associated with consumption levels of the advertised brands of cereals.52 the authors found exposure to the advertisements increased intake of the advertised brands, and that “child-directed advertising influences begin earlier and last longer than previously demonstrated, highlighting limitations of current industry guidelines regarding the marketing of high-sugar foods to children under age 6 years.”53 not surprisingly then, advertising of junk food to children is often cited as a contributor to childhood obesity.54 and logically, why would companies invest in advertising nutritionally poor cereals directly to children unless they expect the investment to increase consumption and sales? minors see thousands of advertisements every year for unhealthful foods and beverages,55 yet young children have not yet developed the ability to view these ads critically.56 this vulnerability is exacerbated by a particular childhood skill, “pester power,” defined as children’s “ability to nag their parents into purchasing items they may not otherwise buy.”57 is pester power a real thing? parents have thoughts on this question based on health eating rsch. (aug. 2014), http://healthyeatingresearch.org/wp-content/uploads/2014/07/ her_marketing_toys_august_14.pdf [https://perma.cc/5vf6-j33x] (observing that marketing of children’s meals using toys has been targeted as a public policy initiative to address childhood nutrition). 49. see infra note 111. 50. see infra §§ ii (a-c). 51. see rita-marie c. reid, embedded advertising to children: a tactic that requires a new regulatory approach, 51 am. bus. l.j. 721, 722 (2014) (“for decades, researchers and children’s advocates have decried the ill effects of advertising to children.”). 52. jennifer a. emond et al., exposure to child-directed tv advertising and preschoolers’ intake of advertised cereals, 56 am. j. preventive med. 35 (2019). 53. id. 54. see, e.g., david burnett, fast-food lawsuits and the cheeseburger bill: critiquing congress’s response to the obesity epidemic, 14 va. j. soc. pol’y & l. 357, 360 (2007). 55. jennifer l. harris, demonstrating the harmful effects of food advertising on children and adolescents, in media & the well-being of child. & adolescents 52, 53 (amy b. jordan & daniel romer eds., 2014). 56. id. 57. how marketers target kids, media smarts, https://mediasmarts.ca/digital-medialiteracy/media-issues/marketing-consumerism/how-marketers-target-kids [https://perma.cc/mr6wyhx6] (last visited mar. 19, 2023). 2023] regulating the marketing of food to minors 309 their firsthand experiences. the fact that companies shifted their marketing of children’s brands in supermarkets from children to adults during covid-19, when family shopping shifted to just one adult at the store,58 suggests that manufacturers were marketing directly to the children before that. because children do not do the family grocery shopping themselves, the only logical influence they have on grocery store purchase decisions is through pleas to their parents. despite parents’ ultimate authority, children do affect parents’ food purchases. one canadian report concludes that “young people have a very strong influence on the whole family’s food choices, parents often choosing to abdicate with regard to healthy eating issues to surrender to the children’s incessant demands.”59 an american journal of law & medicine article from 2015 notes that “[s]tudies have long shown that children are not only more susceptible to marketing than are adolescents and adults, but also that children have the ability to influence family purchases by nagging and pestering their parents . . . .”60 the resulting increased consumption of non-nutritious foods can harm children’s health, both during childhood and in the future.61 both the world health organization and the food and agricultural organization of the united nations recognize the heavy marketing of unhealthy foods and drinks as likely factors contributing to weight gain and obesity.62 the ramifications are serious: the american psychological association frames childhood obesity as “a serious public health problem that increases morbidity, mortality, and has substantial long term economic and social costs.”63 58. see elizabeth crawford, without kids in stores to drive impulse purchases, good2grow pivots marketing to focus on parents, food navigator usa (may 20, 2020), https://www. foodnavigator-usa.com/article/2020/05/20/without-kids-in-stores-to-drive-impulse-purchasesgood2grow-pivots-marketing-to-focus-on-parents# [https://perma.cc/253h-c64g] (“children’s brands that previously relied on ‘the nag factor,’ impulse purchases or being the reward parents give children to behave in stores are pivoting their marketing to target adults now that most families send only one adult to the grocery store to limit exposure to the coronavirus.”). 59. marieève nadeau, food advertising directed at children, que. coal. on weightrelated probs. (jan. 2011), http://childhoodobesityfoundation.ca/wp-content/uploads/2015/ 02/amorel_food_advertising_directed_at_children.pdf [https://perma.cc/9lwp-bynl] (citing jean-francsois henry, marketing de la malbouffe pour enfants, rapport final du projet de recherche présenté au bureau de la consommation d’industrie canada 5 (2006)). 60. christine fry et al., what’s in store: a vision for healthier retail environments through better collaboration, 41 am. j. l. & med. 331, 338 (2015). 61. not only is junk food advertising associated with childhood obesity; childhood obesity rates are associated with adult obesity rates, as well as diabetes, cancer, and cardiovascular disease. see the impact of food advertising on childhood obesity, am. psych. ass’n (nov. 17, 2010), https://www.apa.org/topics/kids-media/food [https://perma.cc/yk68-sw8x]. 62. benedetta f. duramy, childhood obesity and positive obligations: a child-rights based approach, 42 seattle u. l. rev. 87, 97 (2018). 63. id. 310 indiana health law review [vol. 20:301 b. food packaging issues food packaging influences children’s purchase requests,64 and packaged toys and prizes dominate the marketing of food to children.65 i explore packaging generically, the use of toys and prizes specifically66 and product placement in supermarket aisles in this subsection. 1. food packaging practices that harm children two common types of packaging practices that harm children are addressed in subsections (a) and (b) below. these are the direct emotional appeal to children in design of the package graphics and the deceptive, misleading, or inaccurate nutrition claims that can mislead parents to over-estimate the nutritional value of a product. the latter has a negative impact on not only children, but also adults. a. direct emotional appeal to children in design of product graphics manufacturers attract children to their food products using various packaging techniques: bright colors, cartoon characters, childish lettering, associations with play and with fun, and associations with celebrities and sportspersons.67 these design strategies skew children’s brand associations and taste preferences in favor of the products perceived as “fun.”68 the resulting brand associations lead children to prefer such advertised foods, regardless of whether they are healthful.69 lavriša and pravst summarize numerous research findings on this: it is well established that different child-oriented marketing techniques, 64. pomeranz, supra note 39, at 132 (citation omitted). 65. see jennifer r. otten, food marketing: using toys to market children’s meals, healthy eating rsch. (aug. 2014), http://healthyeatingresearch.org/wp-content/uploads/2014/ 07/her_marketing_toys_august_14.pdf [https://perma.cc/2pqm-x54y] (“for restaurants, including toys with children’s meals is the leading form of food marketing directed at children by expenditure.”). 66. toys and prizes are combined into one category, because they have not been clearly distinguished and reflect the same phenomenon. sometimes the inexpensive inserts for children are identified by critics as toys and sometimes as prizes. as the toys by their nature are insubstantial and low-cost gratuities, they can equally accurately be categorized as prizes, such as were classically and historically included in boxes of cracker jack, or as prizes. see karen knapstein, cracker jack: a prize collection that’s a treat for the ages, antiques trader (oct. 4, 2016), https://www.antiquetrader.com/collectibles/cracker-jack-prize-collecting-treat-for-ages [https://perma.cc/e6y3-9gtc] (documenting that cracker jack identified its inserts as prizes from 1912-1925, as novelties from 1925-1932, and as toys from 1932 forward). 67. živa lavriša & igor pravst, marketing of foods to children through food packaging is almost exclusively linked to unhealthy foods, 11 nutrients 1128, 1129 (2019). 68. id. 69. id. at 1128. https://www.ncbi.nlm.nih.gov/pubmed/?term=lavri%26%23x00161%3ba%20%26%23x0017d%3b 2023] regulating the marketing of food to minors 311 such as the use of cartoon characters and similar elements on food packaging, significantly influence children’s food choices and preferences. by using such child-oriented marketing techniques, children are encouraged to like and want products which they see as “fun” and “good tasting[.]” when foods are accompanied with children-familiar characters, children are convinced it tastes and looks better and would more likely ask their parents to buy it for them.70 of course, one should expect companies to advertise their products, and it is not surprising that they focus their advertising using images that directly connect with customers, whatever their age. society accepts advertising as a commercial practice; it becomes questionable when aimed at a population, like minors, who are vulnerable and lack the fully mature cognitive capabilities to process the advertising responsibly.71 the problem is exacerbated when companies add deception to this equation. advertisements targeting children with familiar characters are often deceptive regarding health claims. a 2013 study found that “[n]early three quarters (73%) of food ads targeting children use a familiar character. most of these ads (72%) promote foods of low nutritional quality, yet 53% employ a health-related message.”72 this additional problem of deceptive health claims is addressed next. b. deceptive or inaccurate nutrition claims that can mislead parents into overestimating the nutritional value of a product growing interest in nutrition and dietary health has created concern over food labeling.73 a public health and nutrition article notes that “[a]dult shoppers are increasingly interested in referring to nutrition information on labels to guide their purchase decisions, and misleading information signals intent on the part of companies to deceive and confuse consumers.”74 unfortunately, the authors also observe that misleading nutritional claims are commonplace: 55.5 percent of 119 unhealthful foods that they examined were marketed using claims portraying them as healthy.75 through the food, drug, and cosmetic act,76 the food and drug administration is authorized to protect the public from false claims about the 70. id. at 1133 (citations omitted). 71. see supra note 57 and accompanying text. 72. jessica castonguay et al., healthy characters? an investigation of marketing practices in children’s food advertising, 45 j. nutrition & behav. 571, 571 (2013). 73. jack gainey, note, an examination of trans fat labeling: splitting the third & ninth circuit, 23 wash. & lee j. civil rts. & soc. just. 461, 463 (2017) (citation omitted). 74. mehta et al., supra note 36, at 1768. 75. id. 76. 21 u.s.c. §§ 301-399(g) (codified as amended by pub. l. no. 117-103 (2022)). 312 indiana health law review [vol. 20:301 composition and nutrition of products.77 false and misleading food labeling are prohibited in the highly detailed provisions of section 343 of the statute.78 in a 2007 “dear manufacturer” letter, the fda reminded industry that their oversight governs a wide variety of labeling claims, relating to health, product structure, product function, nutrients, and dietary guidance.79 package nutritional claims are made in two separate places: in the standardized nutrition charts and in the bold generic claims often made as part of a package’s graphics. accuracy of nutrition claims made directly in the standardized nutrition charts is, of course, important,80 as false or deceptive information can mislead parents to purchase products they might otherwise avoid for their children.81 while consumers vary in how often they consult food nutrition labels, most do report using them frequently when buying food products.82 arguably even more influential, though, are the nutrition claims that are hard for any consumer to miss because they are made outside the nutrition chart, typically in big, bold, eye-catching letters and graphics. fda oversight over food labeling is broad and applies not only to the nutrition chart, but also to any general claims made anywhere on the package.83 consumers are more likely to see the bold packaging claims on a product’s marketing graphics than the small print label, and parents frequently misinterpret the meaning of such claims.84 77. milestones in u.s. food and drug law history, fda, https://www.fda.gov/aboutfda/fda-history/milestones-us-food-and-drug-law [https://perma.cc/2mdl-dxsr] (last updated jan. 30, 2023) (hereinafter “milestones”). 78. see 21 u.s.c. § 343. 79. fda, fda-1998-n-0050, guidance for industry and fda: dear manufacturer letter regarding food labeling (2007). 80. for detailed discussion of nutritional information in the labeling itself, see generally danielle m. haikal, an unsealed package: the ninth circuit creates a circuit split when interpreting fda regulations on food label nutrient claims in reid v. johnson & johnson, 57 b.c. l. rev. e-supplement 124 (2016). 81. of course, the value of nutrition information on labels depends on whether consumers use the information, and such consumer use can be variable. see judith a. garretson & scot burton, effects of nutrition facts panel values nutrition claims, and health claims on consumer attitudes, perceptions of disease-related risks, and trust, 19 j. pub. pol’y & marketing 213 (1990) (finding that consumer evaluations and perceptions of disease risk are affected by information regarding fat, but not by information regarding fiber). 82. ramu govindasamy & john italia, the influence of consumer demographic characteristics on nutrition label usage, 5 j. food prod. marketing 55 (2000). 83. chelsea m. childs, note, federal regulation of the “smart choices program”: subjecting front-of-package nutrition labeling schemes to concurrent regulation by the fda and the ftc, 90 b.u. l. rev. 2403, 2406 (2010) (“in exercising its broad grant of jurisdiction over food labeling, the fda considers the claims made or suggested on the package, as well as any material omissions, to determine whether a product’s label is misleading.”) (citation omitted). 84. jennifer l. harris et al., nutrition-related claims on children’s cereals: what do they mean to parents, and do they influence willingness to buy?, 14 pub. health nutrition 2207, 2023] regulating the marketing of food to minors 313 despite broad fda oversight85 and ubiquitous state consumer protection laws, liability for misleading food claims can be spotty. some courts allow questionable food product claims under an assumption that “where a product’s marketing leaves some ambiguity as to its ingredients, reasonable consumers would read the label.”86 this approach is troubling. what the courts label as ambiguity might not be what you or i would consider to be ambiguous. one example comes from the northern district of illinois, where the court determined that the claim “100% grated parmesan” was ambiguous, and therefore the consumer should refer to the nutrition label to see if the product in fact contained other substances.87 despite its acknowledgment that the product’s ingredient list is smaller and less conspicuous than the nutrition label, and that the product contained up to 8.8% of filler,88 the court found the labeling to be non-deceptive under the applicable consumer protection laws.89 this approach is regrettable. a product that the manufacturer calls “100% grated parmesan” might be ambiguous to some, but it also will appear clear and unambiguous to other buyers. they will believe the product will contain all grated parmesan cheese, and not nearly one-tenth filler. the consumer should not be expected to verify the company’s claim by going to the nutrition label to be sure it does not mean something other than what many reasonable consumers will view as the clear, obvious interpretation. if a product nutrition claim is ambiguous, that ambiguity should be deemed unacceptable under the laws that purport to protect us. companies should be clear in the factual claims they make about the ingredients in their products. we should not condone and accommodate unclear marketing claims by placing the onus on the consumer to (1) recognize an ambiguity they may not even see, and then (2) resolve that ambiguity. it is not asking too much to require companies to make ingredient and nutrition claims that are clear, unambiguous, and accurate. these companies of course employ highly sophisticated, expensive research to market their food products effectively to consumers.90 consumers are more casual and less 2207 (2010) (reporting their study findings that “[t]he majority of parents misinterpreted the meaning of claims commonly used on children’s cereals. they inferred that cereals with claims were more nutritious overall and might provide specific health-related benefits for their children; and these beliefs predicted greater willingness to buy the cereals.”). 85. see supra notes 76-79 and accompanying text. 86. cary silverman, in search of the reasonable consumer: when courts find food class action litigation goes too far, 86 u. cin. l. rev. 1, 17 (2018). 87. in re 100% grated parmesan cheese mktg. & sales practices litig., 275 f. supp. 3d 910, 923 (n.d. ill. 2017) (“[t]he description ‘100% grated parmesan cheese’ is ambiguous—as are the other, similar descriptions of defendants’ products—so plaintiffs’ claims are doomed by the readily accessible ingredient panels on the products that disclose the presence of non-cheese ingredients.”). 88. id. at 914. 89. id. at 919-25. 90. see luke laborde & winifred w. mcgee, food for profit: marketing your food 314 indiana health law review [vol. 20:301 sophisticated in exercising our part of the transaction with these companies. many people do not routinely consult nutrition labels,91 and they should not be expected to fact-check every generic front-of-package claim that manufacturers make. companies should be accountable for the accuracy of all their nutrition claims, including the big, bold, eye-catching package language that most consumers cannot miss seeing. 2. marketing food directly to children with included toys by the 2020s, anyone reading this article grew up with a variety of foods sold with a toy or prize included. ipatenco summarizes the strategy, as well as the problems associated with including toys with food92: one of the most powerful marketing tools that fast food restaurants use is the promise of a toy with the purchase of any kids’ meal. the food inside the meal is far less important to most children than the toy that comes with it, the colorado state university extension reports. when fast food restaurants offer versions of the most popular toys on the market, children want to eat the food so they can get the toy. the problem isn’t the toy, but the lack of nutritious food that children eat to obtain the toy.93 most kids’ meals are high in fat, calories, and salt, but low in essential nutrients such as vitamin c, potassium, and iron. fast food restaurants spend more money on toy promotions than any other category of child-oriented marketing.94 all of the major fast-food restaurants have product, pennstate extension (apr. 26, 2019), https://extension.psu.edu/food-for-profitmarketing-your-food-product [https://perma.cc/cd35-gfbc] (discussing this process, and observing, “[m]arketing is more than advertising. it is everything you do to promote your business and your food products from the moment you conceive of a product to the point at which customers buy it.”). 91. most studies on nutrition label access have been done outside the united states. see, e.g., klaus g. grunert et al., use and understanding of nutrition information on food labels in six european countries, 18 j. pub. health 261, 261 (2010) (finding that “[a]cross six product categories, 16.8% of shoppers were found to have looked for nutrition information on the label, with the nutrition grid (table or list), gda labels and the ingredients list as the main sources consulted and calories, fat and sugar the information most often looked for.”). 92. sara ipatenco, what attracts kids to fast food?, sfgate (nov. 27, 2018), https://healthyeating.sfgate.com/attracts-kids-fast-food-1589.html [https://perma.cc/z22e-26qr]. the terms “prizes” and “toys” are indistinguishable, with toys being slightly more expensive and sophisticated than the very cheap prizes that came in certain candy and cereal boxes back in the 1960s. from the standpoint of this discussion, they can be treated as the same, as they both serve the same marketing functions and they both play the same role of engaging children. 93. id. 94. alexis m. etow, comment, no toy for you! the healthy food incentives ordinance: paternalism or consumer protection?, 61 am. u. l. rev. 1503, 1511 (2012). 2023] regulating the marketing of food to minors 315 offered so-called “kids meals” that come with a toy prize.95 some companies create an array of different promotional toys tied to a popular movie.96 a child who undertakes the challenge to collect the entire set may be encouraged to eat substantial amounts of food to meet that goal.97 not only are free toys included with food products; they are also tied to children’s television or movie characters, enhancing both slogan recall and product identification.98 children “associate fictional characters and toys with certain food products, conflating excitement over their favorite cartoon or toy with enthusiasm about a food product.”99 this should lead us to wonder: is it appropriate for companies to engage in this kind of psychological manipulation of a vulnerable group100 that is experiencing substantial health consequences of poor dietary choices?101 regulation of toy prizes to market foods to children is not common, but a notable example was approved by the san francisco board of supervisors in 2010102 and passed into law in 2011.103 it’s often casually referred to as the 95. cortney price, the real toy story: the san francisco board of supervisors healthy food initiatives ordinance, 8 j. food l. & pol’y 347, 350 (2012). 96. see susan linn & josh golin, beyond commercials: how food marketers target children, 39 loy. l.a. l. rev. 13, 18-20 (2006). 97. id. at 19 (“promotions and tie-ins that target children also frequently ac-company films designed for a more general audience. star wars: episode iii--revenge of the sith, released in may 2005, had sixteen food promotions featuring twenty-five different products. many of these promotions encouraged young children to consume large portions of food that are high in calories, fat, and sugar. to collect all seventy-two star wars m&m wrappers, children would have to buy forty-five pounds of m&ms (containing more than 10,000 grams of sugar). to collect all thirty-one star wars super d toys kids would have to buy more than five burger king children’s meals.”) (citations omitted). 98. roseann b. termini et al., food advertising and childhood obesity: a call to action for proactive solutions, 12 minn. j. l. sci. & tech. 619, 630 (2011). 99. id. at 631. 100. vulnerability of minors relates to their still-developing ability to think and reason independently. see jeffrey s. dill, the parent trap: the challenges of socializing for autonomy and independence, 52 society 150, 150 (2015) (discussing independent thinking and the ability to resist negative influences as a key part of child development). 101. see supra note 62 and accompanying text. 102. san francisco bans the happy meal, huff post (may 25, 2011), https://www.huffpost. com/entry/san-francisco-happy-meal-ban-mcdonalds_n_777939?guccounter=1&guce_referrer= ahr0chm6ly93d3cuymluzy5jb20vc2vhcmnop3e9c2fuk2zyyw5jaxnjbytoyxbwesttzw fsk2jhbizmb3jtpuver1rdvczxcz1buyzjdmlkpwrimde0mwu5mgi0ytqxmge5mg e4odc4zjriztyym2eyjnjlzmlnptu3yjywodm1mtuxztqyzdy5ytm3njkxzjflndmz yzg4jmnjpvvtjnnldgxhbmc9zw4tvvm&guce_referrer_sig=aqaaamc5sxhu3u-abixei83rvdzz4cxepobcz7vsw1qlz0u8phdcrjbxyyp_dhwxjhn_3wn8igyz1awx0swb0_rrzfovjz4fzou4onxzoe4jo4pu1mbwh5e0-xiyzyqvkofsrx1uif0p0kqngagkderok jizzuzoymctqkva8bophw#:~:text=san%20francisco%20bans%20the%20happy%20meal. 316 indiana health law review [vol. 20:301 “happy meal ban.”104 the ordinance isn’t a blanket ban on inclusion of toy prizes with food; rather, it prohibits including free incentive items with children’s meals that do not meet threshold nutritional guidelines.105 specifically, take-out meals can only include incentive items if they are sufficiently low in calories, fat, and sodium, and include threshold servings of fruit and vegetables.106 two restaurant chains reviewed in one study both adopted the same creative strategy to comply with the letter rather than the spirit of the ordinance: instead of altering the meals to meet the threshold nutritional requirements for including a free toy, they charge ten additional cents to customers who decide to purchase the toy along with the meal.107 of the meal purchases surveyed in the study, 88 percent of consumers opted to buy the ten-cent toy.108 the authors concluded that banning only “free” toys can inadvertently reduce the chances that restaurants will improve the nutritional content of children’s meals to comply with the law.109 rather than either eliminating toy prizes or improving meal quality, these restaurants in san francisco simply developed a creative loophole that subverts the purpose and the effectiveness of the regulation. c. product placement at children’s eye-levels in supermarkets supermarket design is not haphazard or random. rather, “[g]rocery shopping, start to finish, is a cunningly orchestrated process. every feature of the store—from floor plan and shelf layout to lighting, music, and ladies in aprons offering free sausages on sticks—is designed to lure us in, keep us there, and seduce us into spending money.”110 food manufacturers pay supermarkets “slotting fees” to have their products placed at advantageous levels on grocery shelves.111 for cereals targeted toward %20san%20francisco,majority%20of%208-3%2c%20effectively%20bans%20the%20happy% 20meal [https://perma.cc/6dqy-t352]. 103. san francisco health code, art. 8 § 471.2 (dec. 1, 2011). 104. see, e.g., mcdonald’s finds a way around san francisco’s “happy ban,” nbc news (nov. 30, 2011), https://www.nbcnews.com/business/markets/mcdonalds-finds-way-around-sanfranciscos-happy-meal-ban-flna1c7100983 [https://perma.cc/9rmc-pgpk]. 105. matthew j. parlow, health zoning, 44 fordham urban l.j. 33, 43 (2017). 106. see supra note 104. 107. jennifer j. otten et al., impact of san francisco’s toy ordinance on restaurants and children’s food purchases 2011-2012, 11 preventing chronic disease 1,1 (2014). 108. id. 109. id. 110. rebecca rupp, surviving the sneaky psychology of supermarkets, nat’l geographic (june 4, 2015), https://www.nationalgeographic.com/culture/food/the-plate/2015/06/15/survivingthe-sneaky-psychology-of-supermarkets/ [https://perma.cc/2etk-r749]. 111. sophia mitrokostas, why cereal boxes are at eye level with kids, insider (jan. 14, 2019), https://www.insider.com/cereal-boxes-eye-level-kids-marketing-2019-1 [https://perma.cc/58haesav]. 2023] regulating the marketing of food to minors 317 children, these are the lower shelf levels, i.e., children’s eye levels.112 the strategy is simple: “[k]eeping items like sugary cereal visually and physically accessible to kids is an effective way to sell more product.”113 this approach has been fine-tuned to reach even the smallest of toddlers and children in low-level strollers. whereas characters on adult cereal boxes tend to look straight ahead, the cartoon characters featured on cereal boxes aimed toward children tend to gaze downward.114 the resulting eye contact increases connection with the brand, as well as trust in it.115 placement of sweetened cereals where children can see them and make eye contact with their mascots is a rational—indeed, an ingenious—marketing strategy. if children are a substantial market segment, then attracting them to the product makes sense. but while the strategy may be highly effective, is socially responsible? whatever the answer, companies have not to date curtailed this practice as a matter of corporate social responsibility. there is no evidence that they consider it unethical to market unhealthy products directly to the vulnerable populations of toddlers and children. if the practice is to cease, it will only be through regulations that prohibit it as a matter of public health and consumer protection. d. the controversy over public health interventions to curb these practices policy recommendations to curb these industry practices are controversial. solutions balance “the relationship between juvenile neurodevelopmental factors, legal and social norms, stakeholder interests, and institutional considerations.”116 this section addresses arguments for and against public health interventions around food marketing. 1. arguments in favor of public health interventions around food marketing the case for food marketing interventions usually relies on two prongs. first, children historically have been recognized as a vulnerable population deserving legal protections.117 second, intervention into food marketing can improve overall 112. id. 113. id. 114. marisa taylor, cereal offense: the marketing ploy behind kids’ breakfast, aljazeera am. (apr. 2, 2014), http://america.aljazeera.com/articles/2014/4/2/cap-n-crunch-cerealseyecontact children.html [https://perma.cc/8qzl-n36q]. 115. emily cohn, you’ll never look at cereal boxes the same again, huff post (dec. 6, 2017), https://www.huffpost.com/entry/cereal-boxes-gaze_n_5078704 [https://perma.cc/lu5zts3v]. 116. michael n. tennison & amanda c. pustilnik, “and if your friends jumped off a bridge, would you do it too?”: how developmental neuroscience can inform legal regimes governing adolescents, 12 ind. health l. rev. 533, 586 (2015). 117. for example, children have been protected from rigid enforcement of contracts since the 318 indiana health law review [vol. 20:301 population health and reduce medical costs borne by individuals and society alike. a. children are a vulnerable population deserving legal protections the law has long recognized minors as vulnerable and deserving of protection. for example, contracts made by minors have been voidable under many circumstances for centuries.118 sexual relations with persons below the age of consent is statutory rape because any purportedly “consenting” minors are still developing mentally and emotionally vulnerable, such that any ostensible consent is vitiated.119 government intervention to protect children can, however, become controversial when the threats addressed are considered less serious than these examples, and therefore arguably best kept under the control of parents.120 how serious, then, are the threats to children created by unhealthful diet and nutrition? unhealthful foods do pose substantial threats to children, from which they deserve protection. consider that we have come to replace the old term “adultonset diabetes,” because it is no longer accurate, with the broader term “type-2 diabetes.”121 the poor diets that once caused only adults to develop insulin resistance now cause many children to develop insulin resistance and type-2 diabetes as well, threatening an array of ills including retinopathy, stroke, heart attacks, nephropathy, neuropathy, and ketoacidosis.122 if children are worthy of protection from unscrupulous businesses through voidability of contract, and from sexual exploitation through statutory rape laws, are they not also worthy of protection from disease and early death from poor 15th century, in recognition of their inexperience. see steven wolfe, reevaluation of the contractual rights of minors, 57 umkc l. rev. 145, 145 (1988). 118. see id. (“beginning in the fifteenth century, courts determined that minors needed protection ‘from those who might take advantage of their inexperience [and] from the consequences of their own rash and ill-advised acts. as a result of this determination, courts began to hold that minors were not bound by contracts entered during their minority.”) (citation omitted). 119. see nancy findholt & linda c. robrecht, legal and ethical considerations in research with sexually active adolescents: the requirement to report statutory rape, 34 perspectives on sexual & reprod. health 259, 259 (2002) (“historically, the reason most often provided to justify punishment for statutory rape is that children below a certain age are incapable of making significant decisions: they are unable to consent to sexual intercourse, and thus, they are vulnerable and deserve state protection.”). 120. see francis barry mccarthy, the confused constitutional status and meaning of parental rights, 22 ga. l. rev. 975 (1988). 121. see type 2 diabetes mellitus, harv. health pub. (feb. 23, 2022), https://www.health. harvard.edu/a_to_z/type-2-diabetes-mellitus-a-to-z (“type 2 diabetes is also called type 2 diabetes mellitus and adult-onset diabetes. that’s because it used to start almost always in middleand lateadulthood. however, more and more children and teens are developing this condition.”). 122. complications of diabetes, diabetes uk, https://www.diabetes.org.uk/guide-todiabetes/complications (last visited nov. 1, 2022). 2023] regulating the marketing of food to minors 319 nutrition?123 in this light, harmful marketing of unhealthy foods aimed at toddlers and young children may be irresponsible at best, and deadly at worst. b. regulation can improve overall population health and reduce medical costs borne by individuals and society critics of regulation view it as the parents’ role, not the state’s role, to protect children’s nutrition and food choices: they suggest that the government should not interfere with parental responsibility and prerogative around children’s nutrition.124 proponents of regulation are likely to see this argument as a red herring. no one is trying to take away the role of parents in selecting and buying food for their children. no proposed reforms to date seek to shift the final food purchase and consumption decisions from parents to the state. instead, proposed public health regulations seek to curtail well-heeled companies from practices that make it harder for parents to make healthy choices. and while such actual public health intervention is unobtrusive, the harms it addresses go beyond the children themselves. these harms affect us all. consider data min discussed in 2013: more than half of the adult new york city population (58%) and nearly 20% of new york city public school students (kindergarten through eighth grade) are now overweight or obese. in 2006, obesity cost the nation $147 billion in direct medical costs—insurers in new york state alone spent $11.1 billion in obesity-related medical costs, including $2.7 billion spent by medicare and $4 billion by medicaid. by 2012, obesityrelated medical costs increased to $190 billion for the uninsured, with annual medical spending for each obese person totaling $3,271, compared to $512 for the non-obese. additional indirect costs include decreased productivity, increased insurance premiums, and increased disability costs. thus, in this context, food choices affect not only the individual who makes them, but also all taxpayers.125 2. arguments against regulating food marketing arguments against regulating the marketing of foods and beverages focus on individual rights and responsibilities, specifically the right and responsibility of 123. see sheldon e. litwin, childhood obesity and adult cardiovascular disease, 64 j. am. coll. of cardiology. 1588, 1589 (2014) (“[w]e cannot forestall embarking on the monumental effort that will be required to find methods to control or, better yet, prevent the growing crisis of childhood obesity.”). 124. see, e.g., reps. lee terry & paul broun, terry, and broun: nutritional guidelines are nanny state run amok, roll call (sept. 20, 2011), https://rollcall.com/2011/09/20/terry-andbroun-nutritional-guidelines-are-nanny-state-run-amok/. 125. hery min, large-sized soda ban as an alternative to soda tax, 23 cornell j. l. & pub. pol’y 187, 195 (2013). 320 indiana health law review [vol. 20:301 parents to guide their children’s eating choices126 without government interference. public health initiatives against obesity trigger backlash from both the food industry and consumer rights groups, based on civil liberties arguments grounded in freedoms of speech, choice, and contract.127 detractors of public health interventions couch their opposition in the vernacular of a “national nanny” or “nanny state.”128 they seek to decrease or eliminate government influence on the market transactions between food manufacturers and consumers.129 for opponents of public health intervention, it is solely to role of parents to protect their children.130 from their perspective, public health policies can be objectionable if they “undermine[] individual freedom and personal responsibility.”131 they “worry that the state may remove more and more individual choices in the service of better population health[.]”132 of course, government regulatory forbearance still allows for, and may even encourage, free self-regulation by companies and industry groups.133 selfregulation has an additional benefit of avoiding any first amendment challenges that could be triggered by the regulation of advertising.134 skeptics might argue that if self-regulation were a viable alternative to government control, it would have been implemented by now. research is still needed to explore the extent to which the food and drink industries have or have not stepped up to moderate their own behavior to date.135 126. see cheryl “shelly” taylor page, childhood obesity, and its effects on students’ academic performance, 21 u.c. davis j. juv. l. & pol’y 79, 82 (2017) (observing a belief of many that “the most important participants in creating a healthy lifestyle for a child are the child and the child’s parents.”). 127. michelle m. mello et al., obesity—the new frontier of public health law, 354 new eng. j. med. 2601, 2601 (2006). 128. see janet hoek, informed choice, and the nanny state: learning from the tobacco industry, 129 pub. health 1038, 1041 (2015) (discussing various “nanny state” arguments put forth by industry in response to public health proposals). 129. id. 130. id. 131. jacquelyn h. flaskerud, the nanny state, free will, and public health, 35 issues in mental health nurs. 69, 70 (2014). 132. id. 133. j. howard beales, advertising to kids and the ftc: a regulatory retrospective that advises the present, 12 geo. mason l. rev. 873, 887 (2004). 134. see pomerantz, supra note 39. 135. see parke wilde, self-regulation, and the response to concerns about food and beverage marketing to children in the united states, 67 nutrition rev. 155, 165 (2009) (“improving and evaluating the current self-regulatory system has reached a critical juncture. sound economic and legal perspectives motivate an attempt at self-regulation, but both perspectives also offer justification for stronger measures if self-regulation is insufficient to meet important publicinterest goals. leading reports and influential policymakers describe the current system of selfregulation as an experiment to be evaluated critically with an eye toward possible changes in government policy in the future.”). 2023] regulating the marketing of food to minors 321 the threat of potential government regulation can provide impetus for corporate self-regulation, as in the case of big tobacco.136 massive public and government pressure threatened the industry with increased oversight and regulation, paving the way for the master settlement under which industry voluntarily agreed to constraints on it marketing practices.137 this analogy is examined in the following section. iv. going from public health interventions regarding tobacco to public health interventions regarding food and nutrition as previously shown, the debate over public health interventions pits protection of individual freedom against regulation to improve health outcomes.138 the author recommends in the following section preserving the ultimate decision-making authority of parents while embracing reasonable regulation to help parents make decisions that benefit their children. this kind of intervention has precedent in our recent history. tobacco products were not banned in the united states, but public health policies dramatically reduced smoking through nudges. subsection (a) discusses the tobacco example as a model for regulating children’s nutrition without overly aggressive interventions; subsection (b) makes specific recommendations for moderate public health policies that can save lives and enhance the quality of lives among children, as well as the adults we want them to live to be. a. the tobacco example as a model for moderate regulation an ambitious public health agenda has addressed smoking-related issues, yielding dramatic health improvements that benefit us all. i offer the tobacco case as a tried-and-true example of broad social support for public health intervention, short of product bans, to achieve vast gains in the public well-being while keeping ultimate free choice in the consumer’s hands. the tremendous health risks associated with cigarette smoking were not always as clearly identified and as comprehensively understood as they are today. they became widely recognized in the 1950s due to studies linking cigarette tar to cancer in mice and demonstrating correlation between smoking and lung cancer.139 in the 21st century, these serious risks are well documented and widely understood.140 as summarized by peterson: 136. see the master settlement agreement, nat’l ass’n of atty’s gen., https://www.naag. org/our-work/naag-center-for-tobacco-and-public-health/the-master-settlement-agreement/ [https://perma.cc/wc7a-2da8] (last visited nov. 1, 2022). 137. id. 138. see flaskerud, supra notes 131-32. 139. see williams v. philip morris, inc., 48 p.3d 824, 831 (or. ct. app. 2002). 140. elizabeth mendes, the study that helped spur the u.s. stop smoking movement, am. cancer soc. news (jan. 9, 2014), https://www.cancer.org/latest-news/the-study-that-helped-spurthe-us-stop-smoking-movement.html [https://perma.cc/n2jz-twwu] (noting that most americans 322 indiana health law review [vol. 20:301 cigarette smoking accounts for 400,000 deaths annually—more than aids, alcohol, cocaine, heroin, homicide, suicide, motor vehicle crashes, and fires combined—making cigarettes the leading preventable cause of death in the united states. tomorrow, approximately 4,000 children under the age of eighteen will experiment with cigarettes for the first time and another 1,500 will become regular smokers. of those that smoke regularly, about half will eventually die from tobacco use. tobacco-related illnesses in the united states alone cost approximately $193 billion each year in lost productivity and health care expenditures.141 with increased awareness of these health risks came a number of public health initiatives that successfully and substantially reduced smoking rates in the u.s. whereas around half a century ago, 42 percent of american adults smoked, 15.5 percent smoked in 2016, and 13.9 percent smoked in 2017.142 this stunning achievement was the orchestrated result of a uniquely effective public health campaign that, among other things, modified the marketing practices of tobacco companies.143 some of the public health initiatives around tobacco could, of course, be characterized by individual rights proponents as incursions on personal freedoms. cigarette price increases were achieved through steep excise taxes that raised the cost of choosing to smoke.144 they were a government intervention in the market transaction between seller and buyer that altered the individual economic value proposition of smoking.145 anti-smoking campaigns sponsored by the public’s tax dollars likewise were a centralized government initiative to mold beliefs and behaviors, with a goal of altering individual decision-making.146 born post-baby boom have known all their lives that smoking can cause cancer). 141. ashley peterson, comment, lighting a fire under free speech: the fda’s graphic attempts to reduce smoking rates, 48 u. rich. l. rev. 799, 799 (2014). 142. smoking in america: why more americans are kicking the habit, am. heart ass’n news (aug. 30, 2018), https://www.heart.org/en/news/2018/08/29/smoking-in-america-why-moreamericans-are-kicking-the-habit [https://perma.cc/hn83-u8hb]. 143. david t. levy et al., the impact of implementing tobacco control policies: the 2017 tobacco control policy scorecard, 24 pub. health mgmt. & practice 448 (2018). 144. see gary lucas, saving smokers from themselves: the paternalistic use of cigarette taxes, 80 u. cin. l. rev. 693, 693 (2012) (noting that cigarette tax revenue exceeded $32 billion in 2010). 145. this is not necessarily to say that cigarette taxes that raise consumer prices are repugnant to free market principles. the taxes enable government to collect funds that might cover smokingrelated externalities that are not paid for in the transaction between seller and buyer. these externalities potentially include pollution, health costs to bystanders due to passive smoke inhalation, and health costs to the public as payers of insurance premiums. 146. see kristin m. sempeles, comment, the fda’s attempt to scare the smoke out of you: has the fda gone too far with the nine new cigarette warning labels?, 117 penn. state l. rev. 223, 224 (2012) (suggesting that fda-mandated warning labels “cross over the line of 2023] regulating the marketing of food to minors 323 moreover, whereas individuals had wide berth in choosing where and when to smoke in the 1950s and 1960s, smoke-free laws increasingly eroded free choice on where and when a smoker could light up.147 even smoking cessation programs, the least intrusive of these public health initiatives, have been supported by government dollars and policy choices.148 this ambitious public health approach to tobacco successfully improved our collective lives, without ever taking tobacco products off the market. today, poor diet contributes to individual suffering and public expense, analogous to the effects of smoking. like public health interventions regarding tobacco, policy choices around food and nutrition can reduce disease, delay death, improve quality of life, and avoid unnecessary health care costs that are currently borne by the public. b. proposed regulation and self-regulation to address public health issues around nutrition from a public health perspective, junk food is the new tobacco.149 pennel observes: tobacco’s position has been usurped. cigarette products are no longer responsible for the greatest share of preventable illnesses. rather, obesity, resulting from a combination of the “food industry” and the american appetite, now holds the crown as the most expensive, preventable health care cost. while public animosity towards the food industry may lag behind animosity towards the tobacco industry, public attitude has shifted, demanding tighter control over the food industry. this shift toward holding fast-food, junk-food, and manufacturers of unhealthy food products partially responsible for the growing obesity epidemic is necessary before legislation and judicial action against the food industry can occur. indeed, a similar shift in public opinion helped to tighten regulations on the tobacco industry and eventually hold it liable for the harms associated with tobacco use.150 as previously noted, critics dislike public health regulations, evoking images informative warnings into anti-smoking advocacy). 147. one example is the curtailment of smoking on airplanes, where back rows once actually permitted smoking, but where smoking of course is now prohibited. see 49 u.s.c. § 41706 (2018). 148. one example of this is smoking-cessation programs as a component of wellness programs under the health insurance portability and accountability act and the affordable care act. for detailed discussion of these, see lindsay f. wiley, access to health care as an incentive for healthy behavior? an assessment of the affordable care act’s personal responsibility for wellness reforms, 11 ind. health l. rev. 635, 666-91 (2014). 149. see joshua l. pennel, big food’s trip down tobacco road: what tobacco’s past can indicate about food’s future, buff. pub. int. l.j. 101 (2009). 150. id. 324 indiana health law review [vol. 20:301 of a “national nanny,” arguing that responsibility for children’s nutrition should remain on parents.151 indeed, placing all responsibility for poor nutrition on individual consumers and on the parents of minors could make reasonable sense if food choices were solely under their control. unfortunately, much of the control of individual consumer food choices is aggressively influenced by powerful external forces. diller observes, “[b]ehavioral scientists have understood for decades that when it comes to food, we are anything but fully autonomous. one’s choice of what and how much to eat is strongly influenced by environment and context.”152 we like to see ourselves as discerning, rational actors who recognize marketing manipulation; in reality, we remain susceptible to marketing practices in our purchasing and consumption choices.153 why would companies spend millions on marketing if it did not work? hoek eloquently summarizes the dynamics at work here: deliberate industry interference has often created situations where consumers have access only to incomplete and inaccurate information. these contexts, coupled with consumers’ inherent cognitive biases, mean truly ‘informed choices’ are an academic concept far removed from lay consumers’ everyday experiences. whether the risk behavior involves smoking, consumption of unhealthy foods or unsafe alcohol intake, individuals’ actions largely reflect their commercially constructed environments. unfortunately, these are rarely conducive to considered evaluations of the costs and benefits they might incur immediately and in the future.154 this vulnerability is, of course, exacerbated when the ultimate consumer is a child. given that responsible parenting will vary, and children are worth protecting, reasonable regulations to protect those children just make good sense. woodhouse provides another important perspective on the “national nanny” critique: we think of regulation as interfering with parental prerogative, yet mass marketing does the same thing.155 she observes, “[i]n our times, mass-media marketing has displaced parents as the primary force in the socialization of children. it has compromised true parental autonomy by bombarding our children, and their parents, with toxic images designed to sell unhealthy products.”156 from this vantage, moderate regulation that does not outlaw any food products is most accurately cast as government mitigation of corporate influence, 151. see supra notes 128-32 and accompanying text. 152. paul a. diller, the illusion of autonomy in “food” litigation, 41 am. j. l. & med. 274, 274 (2015). 153. adam benforado et al., broken scales: obesity and justice in america, 53 emory l.j. 1645, 1691 (2004). 154. hoek, supra note 128, at 1042. 155. barbara bennett woodhouse, reframing the debate about the socialization of children: an environmentalist paradigm, 2004 u. chi. l. forum 85, 164 (2004). 156. id. 2023] regulating the marketing of food to minors 325 rather than government prohibition of parental prerogative. even in our sometimes fiercely freedom-oriented, individual rights-focused culture in the u.s., many people do believe “that the government should actively address the obesity crisis . . . .”157 v. recommendations we have discussed the ideological tension around public health interventions, pitting individual freedom/anti-regulation advocates against proponents of public policies to improve nutrition and reduce disease. my approach in attempting to bridge these two perspectives is to resist bans that eliminate ultimate consumer options, while encouraging public policy nudges toward healthier personal choices. the recommendations in this section never ultimately prohibit any consumer food options. rather, they seek to provide some balance against the powerful influence of companies, which often is not apparent to consumers, and to help parents make healthy choices for the children they strive to support and protect. inherent in this approach is a recognition of a central fact: while personal freedom advocates may ideally wish for institutions to keep entirely out of their business and concerns, food companies already sway consumers. reasonable government policies to improve public health can balance the well-financed influence that companies already exert on us. some of the recommendations below are for the public, including parents and others, to advocate aggressively for industry self-regulation. other recommendations here go further, suggesting government intervention through law, regulation, or ordinance. what kinds of initiatives, then, can improve public health while avoiding unnecessarily harsh product bans? a. advocate for voluntary industry self-regulation of serving sizes of sugary drinks a big contributor to increasing child obesity and overweight is the “supersize” or “big gulp” phenomenon. we tend to consume more as portion sizes increase.158 thus when companies enlarge the size of sugary drinks, total consumption of sugary drinks can be expected to increase as well. sugary drinks are made up of empty calories that provide no nutritional value, and their high processed sugar content can cause harmful rapid spikes in blood sugar.159 157. cynthia a. baker, bottomless lines and waistlines: state governments weigh in on wellness, 5 ind. health l. rev. 185, 188 (2008). 158. see b.j. rolls et al., portion size of food affects energy intake in normal-weight and overweight men and women, 76 am. j. clin. nutrition 1207 (2002) (observing diners served macaroni and cheese ate 30 percent more when the serving contained 1000 grams than when the serving contained 500 grams). 159. see sugary soft drinks and diabetes, diabetes.co.uk (jan. 15, 2019), https://www. diabetes.co.uk/sugary-soft-drinks.html (“sweetened, sugary drinks can cause sharp rises in blood 326 indiana health law review [vol. 20:301 regulatory efforts that restrict serving sizes by law may make sense to many, but they are also lightning rods that can increase resistance to effective public health intervention. some might consider regulation restricting serving sizes as offensive governmental interference in free choice. while i personally would support regulation restricting serving sizes as a modest intervention that does not force anyone not to drink as much sugary drink as they want, such regulation can trigger resistance and be counterproductive as a result. what is a workable solution? persuasion. we need to persuade companies to sign on for voluntary commitments, uncoerced by legal or regulatory fiat, to limit individual sugary drink serving sizes as part of their commitment to corporate social responsibility and their efforts to enhance public health. voluntary limits to these serving sizes should not be a prohibitively hard sell to companies, provided they feel assured that there will be widespread industry adoption of the limits. the supersize movement attracted customers with perceived value, and the costs to restaurants became nominal as agricultural policies subsidized the commodities the foods contain.160 the fast-food restaurants all do it, and if they all voluntarily stop doing it, any possible competitive disadvantage to socially responsible sizing would vanish. if anything, all the companies would experience a savings in cost as reasonably priced drinks become smaller. the trick is to get all the players on board to make this change, so that none of them believe they are competitively disadvantaged by it. how might this be done? through a well-planned, persuasive campaign that raises public consciousness of the issue without triggering concerns around individual freedoms. the very moderation of a voluntary approach, rather than a regulatory forced approach, increases the chances that the campaign can be framed in a nonthreatening way, indeed as an all-parties-can-win solution. b. advocate for voluntary industry self-regulation of bundling practices like the previous recommendation, this second recommendation intentionally avoids regulatory edict. as with soda serving sizes, bundling directly concerns the products or product combinations that consumers can choose. consumption choices are sensitive because they relate to consumer freedom. they are more sensitive and delicate than the remaining recommendations in this section, which will recommend actual government regulation of practices that do not directly sugar levels for people with diabetes or glucose intolerance (including prediabetes and gestational diabetes) and so it’s usually best to avoid drinking sugary drinks.”). 160. elizabeth weise, why are portions in u.s. restaurants so big?, usa today (june 2, 2014), https://www.usatoday.com/story/opinion/2014/06/02/food-portions-restaurants/9734413/ [https://perma.cc/4ykg-papc] (“following world war ii, agricultural policy in the u.s. expanded. farmers were able to grow food more cheaply by using fertilizers, pesticides and herbicides. in the 1970s, the government began subsidizing farmers to grow more food. over time, companies have increased their serving sizes to increase their profits, and we all caught on. why have less when you can have more for only a little bit more money?”). 2023] regulating the marketing of food to minors 327 limit consumer product options. voluntary restrictions on how children’s meals are bundled by restaurants are reasonable because they can improve nutritional value while still allowing parents to order any of the products they want, just à la carte rather than bundled. voluntary industry self-regulation to ensure that bundled kids’ meals include healthier drink options, for example, nudge the consumer in that direction, but they do not preclude consumers from ordering exactly what they want for their children, including a less healthful drink. and once again, because this approach is one of persuasion that asks for industry-wide adoption of the socially responsible practices, it is more palatable for all parties than governmentmandated regulation of consumption options. there have been government efforts to regulate kids’ meal bundling practices. chicago recently passed such an ordinance, prohibiting less healthful beverages from being packaged as part of kids’ meals in restaurants.161 according to the city’s press release, the ordinance mandates that “only healthy, non-sugary beverages be marketed as part of kids’ meals at restaurants, making the healthy choice the default choice. parents will be able to ask for sugary drinks, if they wish, preserving consumer choice.”162 while such government regulation of consumption options will seem reasonable to many, it also can trigger backlash and resistance. for example, in 2011, the united states department of agriculture (usda) denied a request from new york state to initiate a pilot program eliminating supplemental nutrition assistance program (snap) benefits for sugar-sweetened soft drinks.163 this typifies opposition in the u.s. generally toward government intervention, despite the fact that in this case, “[t]he primary aim of the food stamp act, now the food and nutrition act of 2008, . . . [was] ‘to provide for improved levels of nutrition among low-income households.’”164 public health regulations are more promising when the intervention relates to increasing information for consumers, and when the intervention does not prohibit consumer options, but protects consumers while maintaining all market choices. the next few recommendations in this section are bolder than the two discussed so far. they propose government regulation rather than campaigns for voluntary industry self-regulation. these recommendations concern the marketing of unhealthy foods, rather than the direct limitation of consumer product or product-bundle options. because such recommendations do not eliminate free consumption offerings, they are less inflammatory to proponents of consumer freedom. 161. press release, cty. of chi., off. of the mayor, only healthy beverages can be marketed with kids’ meals at restaurants under new ordinance (dec. 15, 2021). 162. id. 163. kelly d. brownwell & david s. ludwig, commentary, the supplemental nutrition assistance program, soda, and usda policy, 306 jama 1370, 1370 (2011). 164. id. at 1371. 328 indiana health law review [vol. 20:301 c. address misleading nutritional packaging claims on food products beyond the official nutrition label the official nutrition labels that are placed on packaged food products are informative and useful, covering protein, fat, fiber, sodium, micronutrients, sugar, and added sugar content. unofficial nutritional claims on packages outside of the nutrition label are less scrutinized by law, yet they can be deceptive, misleading, or ambiguous. a 2011 study examined consumer interpretation of children’s cereal package claims such as “supports your child’s immunity,” “whole grain,” “fiber,” “calcium and vitamin d,” and “organic.”165 the study found that “[t]he majority of parents misinterpreted the meaning of claims commonly used on children’s cereals. they inferred that cereals with claims were more nutritious overall and might provide specific health-related benefits for their children; and these beliefs predicted greater willingness to buy the cereals.”166 the authors summarize the study’s conclusions: “[t]hese findings indicate that common front-of-package nutrition-related claims are potentially misleading, especially when placed on products with high levels of nutrients to limit (e.g., sugar, sodium) and low levels of other nutrients to encourage (e.g., fiber, protein). additional regulation is needed to protect consumers in the usa.”167 what kind of regulation would address this concern, while also maintaining first amendment protections?168 my recommendation is bold, but it is also the cleanest, simplest, and most thorough: simply prohibit health claims on food packaging entirely. such a regulation would likely be challenged under the first amendment, but there are strong arguments supporting it, as it doesn’t prohibit food manufacturers from making health claims in their other advertising; rather, it is arguably a time, place, or manner restriction that limits such claims to venues other than the food package itself.169 given that the restriction would apply to all food products, no company would be competitively harmed by the restriction. all companies would be equally constrained, while continuing to be allowed to communicate about their products through other forms of advertising. critics might argue that this is only a half-step that does not go far enough. why not restrict food nutrition claims entirely? the first amendment protects commercial speech, so nutrition claims that are technically true and therefore are not a deceptive trade practice must be permitted in at least some time, place, and 165. jennifer l. harris et al., nutrition-related claims on children’s cereals: what do they mean to parents, and do they influence willingness to buy?, 12 pub. health nutrition 2207 (2011). 166. id. 167. id. 168. while this article does not analyze the constitutional considerations around limitations of marketing unhealthful products to children, pomerantz has analyzed the issue in detail. see pomerantz, supra note 39, at 175-84. 169. see id. 2023] regulating the marketing of food to minors 329 manner.170 this is true even if a nutritional claim is arguably harmful because some customers will lack the nutrition knowledge to understand fully whether the product is healthful or otherwise. this can happen when a poorly informed buyer believes the claim means the product is healthful, when in fact it may not be. a claim that a product is “low fat” can be true, even though the product is also made palatable and attractive by being exceptionally high in unhealthful processed sugar. nonetheless, there is no constitutional legal basis for entirely prohibiting this potentially misinterpreted low-fat claim. the constitutionally defensible compromise i propose here eliminates package claims outside the nutrition label entirely, relegating such claims to other venues that are less immediately prominent and influential than point-of-purchase claims. is this compromise likely, though, to help improve the prevalence of healthful food choices by parents? point of purchase is where any health claims are most salient, and the most immediate of these are right on the product packaging that buyers see while shopping. a parent who is concerned about the health of their child may well be less likely to put a sugary cereal in the cart if it does not have a low-fat claim boldly announced on front of the box. misinterpreted nutritional claims in places other than the product package can, of course, also influence customers to buy unhealthful products. any claims made by the manufacturer in advertising, for example, at least are subject to extant laws that govern deceptive trade practices and misleading advertising. this means that, while the regulation proposed here would limit a prohibition of product marketing claims solely to the product’s package itself, such claims made by the manufacturer elsewhere will not be entirely unmonitored. as always, false nutritional claims in their other marketing venues will be subject to ftc oversight.171 what about ambiguous nutritional claims? we saw earlier that some courts allow companies to make ambiguous, potentially misleading claims, under the theory that the onus is on the consumer to resolve ambiguities by going to the formal product label.172 this is unacceptable, both because it requires the consumer to scrutinize nutritional claims for any plausible alternative interpretations, and because companies ought to bear responsibility to be clear in their marketing claims. accordingly, the appropriate state and federal bodies should promulgate regulation designating ambiguities in nutritional claims as inherently misleading. if these ambiguities cause consumers to believe a product is more healthful than unambiguous, accurate claims suggest, they should be considered a deceptive 170. see id. 171. see erika kincaid, 5 misleading label claims struck down by the ftc, food dive (oct. 16, 2017), https://www.fooddive.com/news/labeling-claims-ftc-misleading/507201/ [https://perma. cc/63au-3cgf]. 172. see supra note 86 and accompanying text. 330 indiana health law review [vol. 20:301 trade practice. d. promulgate reasonable advertising regulations that will reduce exposure of unhealthy foods and drinks to children a uk department of health and social care spokesperson describes a british initiative along these lines: “as part of our obesity strategy to get the nation fit and healthy, we are . . . restricting advertising of foods high in fat, salt and sugar being shown on television before 9 pm and in paid-for advertising online, as well as restricting less healthy food promotions in stores and online.”173 while the specifics of the british advertising restriction may or may not be a good fit for the u.s., it provides an example of the spirit of regulation that we should explore, and eventually adopt, to fit our own culture and legal framework here. the goal should be to fashion public health policy that reduces the exposure of minors to the marketing of unhealthy food products. in fashioning regulation that fits u.s. laws and culture, lawmakers should focus their attention on these questions: (a) how do we define less healthy food products in terms of threshold levels of sugar, sodium, and fat that trigger inclusion within the regulatory restriction?; and (b) what would be optimal marketing restrictions of television and internet advertising—in other words, where are the lines drawn regarding when and in what media certain unhealthful foods and drinks cannot be advertised? while the specifics will require careful consideration, there are some obvious advertising limitations that have the potential to reduce exposure of minors to marketing of unhealthy products. the law should prohibit advertising of unhealthful foods during children’s primary television viewing hours. as already noted, this will require careful consideration and determination of what thresholds will be developed to classify food and drink products as unhealthful. current advertising exposure to minors is high on both television and the internet.174 this means that we also need to delineate internet site criteria that define sites that are targeted to or that have very substantial viewing from minors and promulgate the same advertising restrictions there as we do for television. e. promulgate reasonable retail regulations that will reduce exposure of unhealthy foods and drinks to children in stores regulatory restriction on the shelf placement of less healthful foods and drinks in retail stores, such as supermarkets and convenience stores, should be a palatable regulation even for staunch proponents of individual freedoms averse to aggressive regulation. such limitations would leave adult consumers’ options 173. andrew gregory, uk obesity plan will fail without action on unhealthy food, the guardian (dec. 27, 2021), https://www.theguardian.com/society/2021/dec/27/uk-obesity-strategyunhealthy-food-environment-report [https://perma.cc/glz2-9rz7]. 174. see melinda wenner moyer, kids as young as 8 are using social media more than ever, study finds, n.y. times (mar. 20, 2022), https://www.nytimes.com/2022/03/24/well/family/ child-social-media-use.html (reporting recent increases in screen use among children). 2023] regulating the marketing of food to minors 331 entirely intact and are helpful to adult consumers in decreasing toddler pestering for the unhealthful products that are currently intentionally placed in their view. such regulatory restrictions can improve overall children’s health without costing large manufacturers significant competitive advantage or profit. how would these restrictions work, and why would they have no negative impact on the manufacturers? shelf placement regulation needs to start, as in the previous subsection and potentially using the same metrics, by defining the less healthful products using a formula for added sugar, sodium, and fat content. once these products are defined, the law should delineate the specific product placement restrictions in retail stores. research is needed to specifically determine the eye-level of the protected class, so that regulation can mandate that less healthful products be placed above that level on shelves. since the market for cereals and snacks has long been dominated by largescale players that manufacture both more-healthful and less-healthful products,175 this proposed regulation is unlikely to impose a competitive advantage on any manufacturer; rather, it would impose a desirable competitive disadvantage on each manufacturer’s less healthful products, relative to their more healthful products. and that is exactly the goal we should seek—to support the companies while also shifting consumption, by reasonable regulatory nudge, toward the companies’ more nutritious offerings. because the regulation proposed here would create threshold levels of added sugar, sodium, and fat to distinguish more-healthful from less-healthful options, it would encourage manufacturers to develop and support the healthful products that qualify for the children’s eye-level shelves. should this happen, there would be an overall trend among manufacturers to make their sweet, child-attractive products more healthful than they are right now. f. do not regulate the inclusion of toys and prizes with children’s meals; rather, lobby companies to discontinue voluntarily the association of their meals with toys and prizes as we saw earlier, san francisco attempted to eliminate toy and prize incentives that encourage children to ask for unhealthy food products.176 companies have successfully circumvented the law by charging a minimum price for the added toy, which a large majority of consumers actually do purchase.177 175. eighty-six percent of the u.s. cereal market is concentrated among just four companies, all of which manufacture a wide variety of products that are healthful: general mills, kellogg company, post consumer brands, and quaker oats. karen perry stillerman, how cereal companies and consumers can make breakfast better, the equation (july 24, 2019), https://blog.ucsusa.org/karen-perry-stillerman/how-cereal-companies-and-consumers-can-makebreakfast-better [https://perma.cc/q4su-ya9a]. 176. see supra notes 102-06 and accompanying text. 177. see supra notes 107-08 and accompanying text. 332 indiana health law review [vol. 20:301 this loophole suggests that municipalities and states should either refine ordinances and regulations to close the loophole or focus on other ways to improve children’s health. the pragmatic best choice here is to choose our battles wisely and focus on other ways to improve children’s nutrition while lobbying companies to stop bundling meals with toys and prizes as a matter of corporate social responsibility. while the loophole technically might be closed by prohibiting all bundling of meals and toys, regardless of whether the toys are free or merely reduced in price, this could be a hollow victory. it would engender consumer animus and pushback, as parents roll their eyes at the perceived assault on perceived family fun in fast food restaurants. even if we prohibit all bundling of meals and toys, including both free toys and charging a nominal fee for toys with kids’ meals, there is still potential for effective loopholes. for example, companies could simply sell the toys entirely unbundled from any particular meal, thereby still making their restaurant attractive to kids. and realistically, few of these children, once in the fast-food restaurant, are likely to consume one of the healthful options sometimes offered, unless so directed by their parents. legally attacking the bundling of unhealthful fast-food options with free toys and prizes is a losing battle. it is likely to be unpopular with the public, undermining support for other reasonable public health initiatives while also being unlikely to achieve much if anything in terms of children’s nutrition. this one is best left alone, apart from efforts to persuade companies to stop offering toys as a matter of socially responsible business practice. v. conclusion this article has examined public health challenges associated with poor nutrition, especially regarding minors. it identified company practices that contribute to the problem and explored public health interventions that have the potential to benefit minors. i have attempted to acknowledge tensions between proponents of regulatory public health initiatives and opponents of such initiatives who ground their opposition to regulation in a philosophy of individual freedom and personal responsibility and autonomy. my goal is to be pragmatic, intentionally avoiding any resolution of the philosophical tension itself, and proposing practical solutions, grounded in sound scientific research,178 that can be positioned as mutually palatable, common-sense efforts. my recommendations avoid consumer bans—none of the proposals eliminate any ultimate consumer choice. while self-regulation in industry may be seen as unrealistic,179 self-regulation is proposed only in areas where broadly embraced 178. for detailed discussion of the nature of scientifically sound nutrition research, see generally david l. pelletier et al., expanding the frontiers of population nutrition research: new questions, new methods, and new approaches, 4 adv. nutrition 92 (2013). 179. individual rights proponents who are critical of regulation typically propose relying on the marketplace to protect us, imposing pressures on industry to self-regulate as needed. simon 2023] regulating the marketing of food to minors 333 corporate social responsibility by businesses will not likely hurt profitability. regulation is proposed in some areas, but not in a way that removes ultimate consumer freedom and choice, instead nudging consumers toward more healthful selections—something most consumers will want for their children anyway. these proposed changes are moderate, but they might be achievable, resulting in greater public health gains than more ideologically pure, but less pragmatically feasible, proposals might yield. asks, “can we trust the food industry to self-regulate?” she contends that “[s]elf-regulation presupposes that corporations can recognize their role in society as responsible citizens and will act accordingly. corporations, in general, have no such ability and are, by definition, designed to further one goal and one goal only: to increase profits for shareholders.” michele simon, can food companies be trusted to self-regulate? an analysis of corporate lobbying and deception to undermine children’s health, 39 loy. l.a. l. rev. 169, 171 (2006). see allyn t. taylor et al., the increasing weight of regulation: countries combat the global obesity epidemic, 90 ind. l.j. 257, 265 (2015) (arguing “self-regulatory initiatives have proven insufficient to stem the childhood obesity epidemic, even in high-income countries where resources and political will exist to monitor industry actions.”). patient registries and their governance: a pilot study and recommendations* leslie p. francis** michael squires*** i. introduction patient registries collect information in a systematic way about individuals who share a particular feature of medical interest. as such, they may provide critical resources for medical research, for improving health care, for public health, or for other purposes. registries vary in many important ways. registries may be devoted to specific conditions such as cystic fibrosis (“cf”) or pompe disease. they may gather information about patients who have received particular medical devices such as pacemakers or joint replacements. some registries such as tumor registries or vaccination registries are maintained by state public health departments. others are maintained by non-profits, professional organizations, or academic medical centers. still others are maintained by pharmaceutical companies or medical device manufacturers. some registries are established specifically for research purposes and approved according to the federal regulations governing research with human subjects, while others serve primarily to network patients and their families. some glean data from patient records and may continue to be covered by the federal privacy and security rules for protecting health information. others may gather information from patients themselves or from other sources beyond the scope of these protections. registries also differ in how they use and protect the information they contain. that is, they engage in quite different practices of governance and data stewardship. this article presents data from a pilot study of a selected group of patient registries about their practices of governance and date stewardship. although some of the registries surveyed have implemented robust practices of data stewardship, others have not. the article concludes with preliminary recommendations for improvements based on these findings. ii. patient registries this section provides an overview of what a registry is and the myriad * research reported in this publication was supported by utah center for excellence in elsi research (“uceer”). uceer is supported by the national human genome research institute of the national institutes of health under award number rm1hg009037. the content is solely the responsibility of the authors and does not necessarily represent the official views of the national institutes of health. ** j.d., ph.d., distinguished alfred c. emery professor of law, university of utah s.j. quinney college of law; distinguished professor of philosophy, university of utah; director, center for law & biomedical sciences, university of utah. *** j.d., director of government affairs, utah associated municipal power systems (uamps). http://doi.org/10.18060/3911.0054 44 indiana health law review [vol. 16:43 variations of registries that exist today. a. what are registries? patient registries are difficult to define precisely because they appear in so many different forms. the agency for healthcare research and quality (“ahrq”) offers this formal definition of a patient registry: “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.”1 this definition would encompass only a limited subset of the entities described as patient registries today and performing at least some of the functions of registries. many of the registries in the clinical research and disease communities meet the characteristics of this definition, but others do not in at least some respects. to grasp a fuller picture of the registry world and how data is used within it, it is critical to extend the universe more widely to include the range of efforts to collect a variety of information in a systematic way about patients who share a feature of medical interest. the registry’s purpose drives choices about its participant pool, data collection, data standards, funding sources, and even stakeholders involved in making decisions about the registry. registry stakeholders play critical roles in determining a registry’s purposes and activities. a “stakeholder’s input directly influences whether development of a registry can proceed, and it can have a strong influence on how a registry is conducted.”2 stakeholders are either primary or secondary. primary stakeholders are those responsible for the data collection and management of the registry. secondary stakeholders are distinguished by the fact that they benefit from the data that is collected as part of the registry. these secondary stakeholders might include other researchers, patients, patient organizations, or commercial entities such as pharmaceutical companies. in some instances, a secondary stakeholder could have a greater impact on the purpose and activities of a registry than a primary stakeholder. this situation is especially likely if stakeholders provide funding for the registry. registries have in common that they possess data, sometimes the data is very rich. they may collect information from across the globe about conditions that are very rare or events that are of low frequency. their information may be standardized and collected over long periods of time. registries thus have the potential to be critical sources of information for assessing disease risks, following the natural history of little-known conditions, comparing care quality 1. agency for healthcare research & quality, patent registries, in registries for evaluating patient outcomes: a user’s guide (richard e. gliklich et al. eds., 3rd ed. 2014), https://www.ncbi.nlm.nih.gov/books/nbk208643/ [https://perma.cc/93yq-a24y]. 2. agency for healthcare research & quality, planning a registry, in registries for evaluating patient outcomes: a user’s guide (richard e. gliklich et al. eds., 3rd ed. 2014), https://www.ncbi.nlm.nih.gov/books/nbk208631/#ch2.s19 [https://perma.cc/w5djfzwq]. 2018] patient registries and their governance 45 at different institutions, developing novel treatments, or even hoped-for cures. if commercial enterprises in health care assert trade secrets protection over predictive algorithms they have developed from patient data, information they have about the significance of novel genetic variants, or other analytic methods developed from patient information, registries may also be an independent source of information for medical research or studies of care quality. nonetheless, ongoing upkeep of registries poses considerable administrative and financial challenges. b. the differing characteristics of registries this section describes the wide variety of registry purposes, of entities that maintain registries, of information acquisition by registries, and of registry funding. the size and scope of registries varies enormously, from lists of several hundred patients with rare genetic syndromes to information about nearly a million and a half patients with hip or knee replacements. registries are proliferating and taking many different forms. registries that are expensive to maintain also may diminish their activity levels or become effectively defunct, leaving questions about what is to happen with the data they leave behind. the vast proliferation of registries gives rise to concerns about reduplication, wasted efforts, gaps, and missed opportunities for cooperation. efforts have been made to gather information about what registries are in operation but by no means are complete. the national institutes of health maintains a list of registries functioning at the national level that is explicitly not intended to be comprehensive.3 ahrq maintains a registry of patient registries that allows registry owners to provide information about their registries, including registry collaborators and the status of any clinical trials being conducted.4 other entities such as the national association of rare diseases (“nord”) or sanford research also maintain a significant number of registries and provide resources for small patient groups that may be unable to develop registries on their own. the description that follows draws on these and other sources but it is important to recognize that efforts to provide a systematic description of a widespread and changing phenomenon will inevitably be incomplete. although some registries of registries or registry consortiums also exist—that collect information about registries5 or that seek to further collaboration among registries6—the focus of 3. list of registries, nat’l inst. health, https://www.nih.gov/health-information/nihclinical-research-trials-you/list-registries [https://perma.cc/525g-ytd6] (last reviewed aug. 8, 2018). 4. about the registry of patient registries (ropr), agency for healthcare res. & quality, https://patientregistry.ahrq.gov/about/ [https://perma.cc/5u3d-uudl]. 5. see listing of clinical trial registries, u.s. dep’t of health & human servs. (may 28, 2015), https://www.hhs.gov/ohrp/international/clinical-trial-registries/index.html#_edn2 [https://perma.cc/p6an-pk3p]; wendy s. rubinstein et al., the nih genetic testing registry: a new, centralized database of genetic tests to enable access to comprehensive information and improve transparency, 41 nucleic acids res. d925 (2013), https://doi.org/10.1093/nar/gks1173 46 indiana health law review [vol. 16:43 what follows will be registries collecting information about individual patients. 1. registry purposes the wide variety of registry purposes includes collecting contact information about individuals with particular conditions, assessing the incidence and prevalence of conditions, studying the natural history of conditions, assessing treatment safety and efficacy, comparing treatment outcomes for patients, engaging in clinical research, and providing support for patients and their families. individual registries may, of course, serve many of these different functions. estimates are that over 7,000 rare diseases have been identified, many of which are genetic in origin and manifested in childhood. while a disease is classified as “rare” in the u.s. if it affects fewer than 200,000 patients,7 some very rare syndromes have been diagnosed in as few as a handful of individuals worldwide.8 information about patients with these conditions may be difficult to assemble because they occur so infrequently, yet valid studies require adequate sample sizes. registries have been developed to address this challenge. in their simplest form, these rare disease registries collect contact information about patients with an identified condition who may be interested in entering research studies devoted to their disease and who otherwise might be very difficult to contact in a coordinated way. for example, the rare diseases clinical research network of the national center for advancing translational science maintains a contact registry for patients to sign up, describe their conditions, and be open to contact for participation in clinical studies.9 the coordination of rare diseases registry at sanford research aims to work with patient advocacy groups to create [https://perma.cc/m664-x2l3] (discussing registry of genetic tests). 6. for example, the u.s. fda is now facilitating a public-private partnership to facilitate collaboration among the over 30 orthopedic registries now in existence. int’l consortium orthopaedic registries, http://www.icor-initiative.org [https://perma.cc/7j77-2u5g]. 7. faqs about rare diseases, nat’l ctr. for advancing translational sciences, genetic & rare disease info. ctr., https://rarediseases.info.nih.gov/diseases/pages/31/faqsabout-rare-diseases [https://perma.cc/bs65-7x6e] (last updated nov. 30, 2017). the u.s. classification of a disease as “rare” comes from the orphan drug act of 1983. id. the european union classifies a disease as rare if it occurs in fewer than one out of 2,000 patients. id. 8. examples of extremely rare conditions include hutchinson-gilford progeria, a premature aging syndrome diagnosed in 130 patients since it was first identified in 1886, hutchinson-gilford progeria syndrome, genetics home ref. (oct. 16, 2018), https://ghr.nlm.nih.gov/condition/ hutchinson-gilford-progeria-syndrome#statistics [https://perma.cc/2al8-dh8a], and fields condition, a progressive neuromuscular condition diagnosed only in the two twins who have it, what is it like to live with a rare disease?, nrs healthcare (feb. 27, 2018), https://www. nrshealthcare.co.uk/articles/news/what-is-it-like-to-live-with-a-rare-disease [https://perma.cc/ mu4c-e5hr]. 9. rdcrn contact registry, rare diseases clinical res. network, https://www.rarediseasesnetwork.org/registry [https://perma.cc/j88e-5wez]. 2018] patient registries and their governance 47 registries of people with diseases such as bohring-opitz syndrome, a rare mutation in the askl1 gene.10 registries devoted to lysosomal storage diseases in children are another good example of registries aimed to assemble sufficient numbers of individuals with unusual conditions to enable sound research studies.11 rare disease registries may also aim to study the natural history of these conditions. because they are diagnosed so infrequently, little may be known about whether the course they take is highly variable in different patients or indeed whether there are patients with milder forms of the condition who have not been recognized. nord now has a project to establish registries to study the natural history of 20 rare diseases, such as galactosemia.12 these registries ask patients (or their family members on their behalf) to update information regularly so that better understanding can be developed of how the disease progresses in different patients.13 the nord project also partners with the food and drug administration to identify patients who may be interested in participating in clinical trials aimed to develop potential treatments for these conditions.14 registries may also be devoted to improving treatment for conditions that occur more frequently. one of the longest-operating registries is the cystic fibrosis foundation patient registry which contains nearly 30,000 patients being treated in 282 different programs offering care for cf.15 in addition to serving as a resource for participation in clinical trials and research, this registry provides a resource for assessing approved therapies, for comparing treatment options, and 10. research with cordr, sanford res. www.sanfordresearch.org/specialprograms/ cords/researchers/ [https://perma.cc/38rv-fj9e]; what is bos?, bohring-opitz found., http://bos-foundation.org/whatisbos [https://perma.cc/zkl6-x4vu]. 11. see e.g., simon jones et al., disease registries and outcomes research in children: focus on lysosomal storage disorders, 13 pediatric drugs 33 (2011). 12. nord-fda natural history study frequently asked questions, nat’l org. for rare disorders, https://rarediseases.org/for-patient-organizations/ways-partner/patient-registries/nordfda-natural-history-study-faq/ [https://perma.cc/cjg7-e93w]; press release, national organization for rare disorders, nord announces 20 rare disease patient groups selected to develop natural history studies as part of fda cooperative agreement (apr. 19, 2016), https://rarediseases.org/ nord-announces-20-rare-disease-patient-groups-selected-to-develop-natural-history-studies-as-partof-fda-cooperative-agreement/ [https://perma.cc/bl3e-b8zg]. 13. pamela gavin, the importance of natural histories for rare diseases, 3 expert opinion on orphan drugs 855 (2015). 14. information on clinical trials and research studies nat’l org. for rare disorders, https://rarediseases.org/for-patients-and-families/information-resources/info-clinical-trials-andresearch-studies/ [https://perma.cc/v3ce-qv88]; anne r. pariser, importance of natural history studies in rare diseases, https://events-support.com/documents/pariser.pdf [https://perma.cc/ lwc2-389e]. 15. cystic fibrosis foundation patient registry highlights, cystic fibrosis found. (2017), https://www.cff.org/research/researcher-resources/patient-registry/2017-cystic-fibrosisfoundation-patient-registry-highlights.pdf [https://perma.cc/wlh2-ctgp]. 48 indiana health law review [vol. 16:43 for improving care quality.16 registry development also serves implementation of learning health care systems. the idea of a learning healthcare system is to continuously capture and present the best available evidence tailored to patient care.17 registries of patients with the condition at issue can provide continuing updated feedback about outcomes of similar patients, and thus assist in evidence-based treatment recommendations for particular patients. for example, there is now a collaborative health outcomes information registry that integrates patient data into an open source platform to enable physicians to tailor care to their patients needing pain management.18 a parallel registry has been established for pediatric patients.19 clinical research is another area for registry development. there are national and international requirements for certain clinical trials to be listed in public registries so that the public can acquire summary information about the trial, such as its sponsor, recruitment locations, inclusion criteria, and outcomes.20 particular clinical trials may also create patient registries that are maintained during the period of the trial. for example, patients with intracranial arterial stenosis and a high risk of stroke were entered into a registry designed to evaluate the technical success of stenting with a particular stent device.21 this registry followed patients for a year after insertion of the stent.22 other registries collect ongoing data about particular treatments or medical devices. for example, the american academy of orthopedic surgeons maintains a registry of patients who have received hip or knee replacements which included over 1,414,000 procedures by 2018,23 and the american college of cardiology maintains a suite of ten registries aimed to improve the evidence base for cardiac care.24 a registry of all genetic tests maintained by the national institutes of 16. id. 17. best care at lower cost: the path to continuously learning health care in america 136 (mark smith et al. eds. 2013), https://www.nap.edu/read/13444/chapter/1#xvii [https://perma.cc/j4js-rmy6]. 18. clinical, collaborative health outcomes info. registry, https://choir.stanford. edu/clinical-practice/ [https://perma.cc/2qjd-854k]. 19. rashmi p. bhandari et al., pediatric-collaborative health outcomes information registry (peds-choir): a learning health system to guide pediatric pain research and treatment, (sept. 1, 2017) (unpublished manuscript) https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4988911/ [https://perma.cc/c6sb-xsnf]. 20. listing of clinical trial registries, supra note 5. 21. o.o. zaidat et al., the nih registry on use of the wingspan stent for symptomatic 70–99% intracranial arterial stenosis (nov. 26, 2012) (author manuscript), https://www.ncbi. nlm.nih.gov/pmc/articles/pmc3506389/ [https://perma.cc/8mtb-s63d]. 22. david j. fiorella et al., us wingspan registry 12-month follow-up results, 42 stroke 1976 (2011). 23. a growing network, am. acad.orthopedic surgeons, am. joint replacement registry, http://www.ajrr.net/ [https://perma.cc/uq8y-ck46]. 24. registries, am. college of cardiology, https://cvquality.acc.org/ncdr-home/ 2018] patient registries and their governance 49 health collects information submitted by test providers about what the test measures, where it can be administered, and any evidence of its analytical and clinical validity and clinical utility but does not acquire information about individual patient test results.25 still other registries are designed for public health purposes to assess the incidence and prevalence of selected conditions. for example, forty-six states and the district of columbia receive funding from the u.s. centers for disease control and prevention (“cdc”) to maintain state cancer registries that collect incidence and mortality data.26 these registries may be used to identify high-risk groups of patients or to investigate the possibility that there are cancer clusters with environmental causes.27 to take another example, forty-three states have birth defect tracking systems that collect information about the incidence of defects and use the data for prevention, referral, and early intervention treatment for patients.28 2. entities maintaining registries the entities maintaining registries are as diverse as the registries themselves. some registries are maintained by federal or state public health authorities. to illustrate with one state, utah maintains a cancer registry,29 a trauma registry,30 an immunization information system,31 and a birth defect network.32 in addition, utah established a stroke and cardiac registry by statute in 2018.33 other registries are maintained by non-profit organizations devoted to particular diseases. the patient registry maintained by the cystic fibrosis registries [https://perma.cc/clr7-qc8x]. 25. rubinstein et al., supra note 5. although this is called a registry, it is not one in the more standard sense that it collects data about individual patient. 26. national program of cancer registries, ctrs. disease control, https://www.cdc.gov/ cancer/npcr/index.htm [https://perm.cc/nvm9-4jth] (last updated oct. 25, 2018). 27. national program of cancer registries (ncpr), centers for disease control & prevention (mar. 27, 2018), https://www.cdc.gov/cancer/npcr/index.htm [https://perma.cc/ 2abm-v8m6]. 28. state-based tracking systems, centers for disease control & prevention (nov. 30, 2017), https://www.cdc.gov/ncbddd/birthdefects/states/index.html [https://perma.cc/d3wb3tut]. 29. utah cancer registry, huntsman cancer inst. u. utah https://uofuhealth.utah.edu/ utah-cancer-registry/ [https://perma.cc/gxh2-kj3j]. 30. welcome to the utah trauma registry!, utah trauma registry, https://www. utahtrauma.org/ [https://perma.cc/v4bs-mpfy]. 31. utah statewide immunization information system, utah dep’t health, http://www. usiis.org/index.shtml [https://perma.cc/u5q9-kmmb]. 32. utah birth defect network, utah dep’t health, https://health.utah.gov/cshcn/ programs/ubdn.html [https://perma.cc/xd9w-m8de] (last updated oct. 4, 2018). 33. utah code ann. § 26-8d-101—105 (lexisnexis 2018). 50 indiana health law review [vol. 16:43 foundation34 is an example, as is the newer world bleeding disorders registry created by the world federation of hemophilia.35 other registries are maintained by academic medical centers or other not-for-profit entities conducting clinical research, such as sanford research.36 still other registries are maintained by professional organizations. the cardiac and orthopedic registries described above are examples. the registries of the american college of cardiology provide a number of the functions of professional organizations, including networking, quality improvement, and certification. the joint replacement procedure registry of the american academy of orthopaedic surgeons is explicitly aimed to improve care quality and reduce rates of surgical revision.37 finally, some registries are maintained by provider organizations, health care payers, or pharmaceutical and medical device companies. some of these organizations are non-profits but many others are for-profit corporations interested in using registry data to further their corporate goals. these registries are especially useful for optimizing care, reducing care costs, furthering understanding about the value of treatments, and developing new treatments.38 controversies may arise, however, if patients providing data believe they are contributing to the advancement of knowledge about their disease while the ultimate outcome of the use of the registry information is a commercially marketed product protected by intellectual property rights, such as a genetic test or a novel pharmaceutical.39 3. sources and types of registry information much of the value of registries lies in the utility of the data they collect. the utility of the registry is found in the integrity of its data and whether the data can be shared and utilized by a registry’s stakeholders and potential partners. registry data is most useful if it is standardized. registries are urged to include similar core components and to structure the data in ways that further interoperability. standard core components include a description of the disease that will be 34. patient registry, cystic fibrosis found., https://www.cff.org/research/researcherresources/patient-registry/ [https://perma.cc/5nj2-best]. 35. wfh world bleeding disorders registry, world fed’n hemophilia, https://www.wfh. org/en/wbdr [https://perma.cc/y85v-zrky] (last updated jan. 2018). 36. research with cords, sanford res., www.sanfordresearch.org/specialprograms/ cords/researchers/ [https://perma.cc/5vva-gv5y]. 37. american joint replacement registry, am. acad. orthopedic surgeons, http://www. ajrr.net [https://perma.cc/dxs7-9n2t]. 38. brian kelly, registries and the future of medicine, pharmexec (may 16, 2016), http://www.pharmexec.com/registries-and-future-medicine [https://perma.cc/6qxh-lsxn]. 39. such was the controversy when patients with canavan disease contributed data and biological samples to researchers who then developed a test to identify the gene and patented the test. greenberg v. miami children’s hosp. research inst. inc., 264 f. supp. 2d 1064 (s.d. fla. 2003). 2018] patient registries and their governance 51 followed, a determination of effective standards for data collection, and measurement of data results.40 as registries increasingly collect data from multiple sources and share data cooperatively, interoperability poses significant challenges, however.41 registries acquire information from varied sources. some contain information drawn directly from medical records. for example, the registry devoted to pompe disease, a glycogen storage disorder, tracks the clinical outcomes for patients with this condition as they are recorded in the medical records of the patients’ treating physicians.42 some registries such as cancer registries contain data reported by health care providers. other registries contain information entered by patients themselves or their family members. some registries draw data from multiple sources, including medical records directly from providers, medical records uploaded by participants, and additional information provided by patients themselves.43 registries may also have data that allows research on the impact of exposure to traumatic events or environmental disasters. for example, there is a registry of rescue workers and people who were in the immediate area of the world trade center disaster,44 and a registry has recently been established for people who were in houston during hurricane harvey.45 registries also vary on whether the information in them is collected with the consent of the participants. when registries are constructed as part of clinical research and contain identifiable patient information, patients (or their responsible persons on their behalf) consent to participation. consent may permit data collection over extended periods of time, however, and patients may lose track of their participation in the registry. moreover, many registries are devoted to conditions that are manifested in infancy or early childhood; in such cases, parents may enter their children into the registry without the child’s knowledge or consent. in some cases, longitudinal registries may require re-consent for the 40. agency for healthcare research & quality, supra note 1. 41. kátia regina da silva et al., correction: glocal clinical registries: pacemaker registry design and implementation for global and local integration – methodology and case study, plos one (july 25, 2013), https://journals.plos.org/plosone/article?id=10.1371/journal.pone. 0071090 [https://perma.cc/5lca-h3ap]. 42. pompe disease registry, u.s. nat’ libr. med. (oct. 4, 2005), https://clinicaltrials.gov/ ct2/show/nct00231400 [https://perma.cc/3fqh-bp9s]. 43. see accelerate preeclampsia research, preeclampsia registry https:// preeclampsiaregistry.org/ [https://perma.cc/y68w-gpgr] (registry participants have the option of uploading themselves actual information into their online profile that they can edit and use, but that is also used by the registry). 44. world trade center health registry, nyc 9/11 health, https://www1.nyc.gov/site/ 911health/about/wtc-health-registry.page [https://perma.cc/9xup-nspc]. 45. houston partners announce launch of post-harvey health registry, envtl. defense fund (apr. 25, 2018), https://www.edf.org/media/houston-partners-announce-launch-post-harveyhealth-registry [https://perma.cc/9yee-9kr4]. 52 indiana health law review [vol. 16:43 continued participation of children in the registry after they reach adulthood.46 registries that function to identify patients who may be interested in participating in clinical research will typically require consent to participation on a study-bystudy basis. when registries are assembled from data submitted by patients themselves, patients will presumably be aware of their involvement in the registry and the information they have submitted. other registries may acquire data without either the consent or the knowledge of the individuals from which registry data is drawn. as described below, data that has been de-identified are not considered individual data for regulatory purposes. inclusion of identifiable data in registries maintained by public health, moreover, may occur without either the consent or even the knowledge of the patient or his or her decision-maker. while the scope and geographic reach of some registries may remain confined to a region of the country, an increasing number of registries not only include data about patients treated in the united states, but also data from patients scattered across the globe. when diseases are quite rare—as many genetic disorders may be—larger national or international inclusion criteria may be necessary to acquire sufficient clinical data to be informative about the prevalence and natural history of the disease or to facilitate translational research.47 the source of registry data is particularly important to how the data are protected legally in the u.s. as discussed below, registry data obtained from patient medical records and maintained in entities covered by the u.s. privacy and security rules protecting health information receives quite comprehensive protection against misuse. once information leaves the entities covered by these rules, however, it receives far less protection. information downloaded from protected systems may lose the protections to which it was initially subject, and information in registries collected from patients or other sources will never have had that protection. information entered by patients themselves or drawn from non-health care sources is largely unprotected by federal law. international data protection standards, and especially the european union data protection regulation,48 come into play when data crosses national borders. the european regulation is far more protective that u.s. privacy law, and it remains to be seen whether it will pose difficulties for registries transferring information between jurisdictions. registries also vary widely in the sensitivity of the information they contain. those registries that serve primarily as a means for identifying and connecting people with particular disease conditions may contain little sensitive information, 46. leslie p. francis, patient registries: patient consent when children become adults, 7 saint louis u. j. of health l. & pol’y 389-404 (2014) (adult consent to continued participation in patient registries). 47. e.g., david m. ng et al., the role of patient registries for rare genetic lipid disorders, 29 current opinion lipidology 156, 156-162 (2018). 48. commission regulation 2016/679, 2016 o.j. (l 119/1) (eu) (regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing directive 95/46/ec (general data protection regulation)). 2018] patient registries and their governance 53 although even contact information may be troubling if it enables people to be traced and harmed.49 some registries collect contact information only and require further communication and consent before participants are contacted about sharing information for research or other purposes. for example, a registry may be contacted by researchers interested in studying their participants, and the registry may then contact their participants to ask whether they are interested in participating in the proposed study. registries that function in this way raise far more limited confidentiality and other data use concerns than registries that share contact information directly with third parties or that collect far greater amounts of information about participants. other registries attempt to mitigate concerns about confidentiality and scope by limiting their information to de-identified data. there are significant controversies about the success of de-identification strategies,50 however. primary problems with de-identification occur when data sets are combined. risks of re-identification depend on what other information may be available for combination with a particular set of de-identified data. that the availability of other data may not be easily predicted in advance raises particularly difficult challenges for de-identification strategies. such difficulties in prediction are especially noteworthy for registries that collect data longitudinally over comparatively long periods of time. even when data are deidentified, however, other concerns beyond confidentiality may remain. one particular concern is that inferences may be drawn about group members based on a conjunction of characteristics that may apply even to individuals not included in the registry.51 4. registry funding in most instances, the size, scope, and activities of a registry will be determined by the funding that is available. collecting, curating, and protecting data are expensive activities. even if they have been originally established on a sound financial basis, registries may be challenged to remain in operation if they lack reliable ongoing funding sources. for this reason, entities supporting rare diseases, such as nord, provide funding for registries and their operation. diverse groups of stakeholders have contributed to a wide variety of registry funding models. some registries are 501(c)(3) non-profit organizations, or 49. testimony of sarah tucker to the national committee on vital and health statistics, nat’l comm. on vital and health stats. (june 15, 2010), https://ncvhs.hhs.gov/wpcontent/uploads/2014/05/100615p09.pdf [https://perma.cc/85ed-bclq]. 50. these concerns apply even to data de-identified the extent stipulated by the health insurance portability and accountability act (hipaa), 45 c.f.r. § 164.514(a), (b) (2018).) see e.g., bradley malin, a de-identification strategy used for sharing one data provider’s oncology trials data through the project data sphere® repository (2013), https://www.projectdatasphere.org/projectdatasphere/html/resources/pdf/deidentification [https://perma.cc/5wj7-2rda]. 51. john g. francis & leslie p. francis, privacy, confidentiality, and justice, 45 utah j. of soc. phil. 408, 408-431 (2014). 54 indiana health law review [vol. 16:43 maintained by these organizations, and funded largely by donations and fundraising efforts. some receive funding from the institutions hosting them such as academic medical centers; some of this support may take the form of in-kind financial assistance. many of these registries receive and are dependent on federal grant support, especially from nih; the lifespan of grant-supported registries may, however, be the lifetime of the grant. registries that are supported by professional organizations may function on a membership model, with individuals or their institutions paying dues or membership fees. on these models, registry data and services are available to feepaying members only. other registries are funded by commercial entities such as pharmaceutical companies. an example of a commercially-funded registry is the registry devoted to gaucher disease, an autosomal recessive storage disorder in which patients cannot metabolize a particular lipid.52 the registry has been in operation since 1991.53 it is supported by genzyme.54 it currently houses records of over 6000 patients from sixty-two countries.55 one common theme in the registry landscape with regard to registry funding is that registry stakeholders play a major role in the source of a registry’s funding.56 iii. legal protections for information in registries like registries themselves, the legal protections that apply to them vary in many ways. this section describes the two u.s. federal regulatory structures that apply to protect information in some registries: the common rule, governing research with human subjects, and the health insurance portability and accountability act (hipaa), governing privacy and security rules. other regulatory structures may also apply to registries but are beyond the scope of this description. at the u.s. federal level in the background is the federal trade act prohibition on unfair or deceptive trade practices that requires registries to abide by any data protection assurances they make explicitly and not to collect information in ways people might not expect and that could be harmful to them in ways they are ill-equipped to prevent.57 in the u.s., several states are engaging in their own efforts to protect data privacy. there are also many trans-national regulations, the most notable of which is the european union data protection regulation, and other data protection regulations in jurisdictions outside of the u.s.58 52. neil j. weinreb & paige kaplan, the history and accomplishments of the icgg gaucher registry, 90 am. j. hematology s2, s2-s5 (2015). 53. id. 54. id. 55. id. 56. id. 57. federal trade commission act § 5, 15 u.s.c. § 45(a)(1) (2018). 58. 2016 o.j. (l 119) 1. 2018] patient registries and their governance 55 a. the common rule and patient registries many patient registries are constructed in settings that require conformity with the federal regulations governing research subjects. strictly construed, these regulations apply to research receiving federal funding or to research that will be submitted to the fda for approval of drugs or devices. however, many institutions apply the federal regulations governing research to all research they conduct; thus, registries maintained by academic medical institutions will typically be governed by the federal regulations. the fda regulations and the common rule differ somewhat but in ways that are not relevant to this discussion; what follows is a summary of common rule requirements as they apply to registries. the common rule defines “research” as “a systematic investigation . . . designed to develop or contribute to generalizable knowledge.”59 public health surveillance activities are excluded from this definition.60 collection of information is not “human subjects research” if the information is not collected through intervention or interaction with the individual or does not involve identifiable private information or biospecimen.61 registries containing neither individually identifiable information nor assembled by contact with the people about whom they contain information are thus not covered by the common rule.62 if information is collected from the medical records of identifiable individuals but recorded in the registry in a manner that does not allow the identity of the individuals to be readily ascertained, the individuals are not contacted for the research, and the researcher does not make efforts to reidentify the individuals, research using that information is exempt from further common rule requirements.63 use of identifiable information in registries is also exempt from the common rule if it is for health care operations or for public health activities; in these cases, the research is covered by the hipaa privacy and security rule, described below. under the common rule, when registries engage in research with identifiable human subjects, consent is required unless the research meets the requirements for waiver of consent.64 these requirements are that the research poses no more than minimal risk, could not be practicably carried out without the waiver or without the use of the information in identifiable form, and will not adversely affect the rights or welfare of the subject.65 in addition, any pertinent information should be provided to subjects after the research has been conducted, if providing 59. 45 c.f.r. § 46.102(l) (2018). 60. 45 c.f.r. § 46.102(l)(2) (2018). 61. 45 c.f.r. § 46.102(e)(1)(i)-(ii) (2018). 62. 45 c.f.r. § 46.101(a) (2018). 63. 45 c.f.r. § 46.104(d)(4)(ii) (2018). 64. 45 c.f.r. § 46.111(a)(4) (2018). 65. 45 c.f.r. § 46.116(f)(3)(i)-(iv) (2018). 56 indiana health law review [vol. 16:43 this information is appropriate.66 consent must include the risks and benefits of the research, including risks of loss of confidentiality; the extent to which the confidentiality of records will be maintained must be stated clearly as well.67 for the information to be stripped of identifiers and then reused in additional research without additional informed consent, this option must be clearly stated in the consent form.68 the common rule now also permits a form of “broad consent” to research involving the reuse of identifiable private information; such broad consent must include a general description of the types of research that may be conducted, a description of the identifiable information that might be used, a description of the time frame in which it is anticipated that the information will be maintained and used (a frame that explicitly may be indefinite), a description of any plans to share information about research and its results, and an explanation about how to contact researchers.69 the privacy of subjects and the confidentiality of data must also be appropriately maintained.70 to summarize, the common rule thus presents a complex set of consent requirements for registries conducting research with human subjects. registries not conducting research, or not containing information or drawn from information about identifiable human subjects, are not covered by the common rule. registries may also be beyond the common rule’s coverage when they are created by institutions that do not receive federal funding and are not intended to be used in the development of products requiring fda approval for marketing. informed consent may otherwise be required for research involving information in registries—but this consent may be broad or waived. the consent mechanisms of the common rule are thus limited at best in protecting the information in registries. b. the hipaa rules and patient registries the hipaa security and privacy rules apply to identifiable health information possessed by hipaa-covered entities. these entities are health care providers who transmit any information in electronic form; entities also include health plans and health care clearinghouses.71 hipaa also covers the “business associates” of covered entities—that is, entities receiving identifiable health information from covered entities in order to provide functions such as cost analytics, quality of care analytics, legal advice, accounting services or a host of other business functions required by health care organizations.72 entities not included in these definitions are not covered by the hipaa rules. when 66. 45 c.f.r. § 46.116(f)(3)(v) (2018). 67. 45 c.f.r. § 46.116(b)(2), (5) (2018). 68. 45 c.f.r. § 46.116(b)(9)(i) (2018). 69. 45 c.f.r. § 46.116(d)(2)-(7) (2018). 70. 45 c.f.r. § 46.111(a)(7) (2018). 71. 45 c.f.r. § 160.103 (2018). 72. id. 2018] patient registries and their governance 57 information is transferred out of the hipaa domain—for example by a patient request for records to be transferred—the transferred information no longer has the protections accorded by hipaa, although the original copy possessed by the covered entity would continue to be protected. under the hipaa security rule, covered entities must perform an assessment about security risks and implement reasonable security plans.73 security has three aspects. the first is administrative security: proper training of staff so that they do not risk security breaches, for example, sharing passwords, using very weak passwords, or letting people into files who have not been properly authenticated.74 a second is physical security: the data from destruction or loss, such as when the data are stored on a portable device, and the portable device is taken where it can be lost or stolen.75 the third is technical security which is achieved by methods such as encryption and automatic logoff.76 the hipaa privacy rule also provides significant protections for health information that it covers. most importantly for this discussion, patients have rights to receive copies of most of their records77 and to request amendments if they identify errors.78 authorization from patients is required if information is to be used in research; thus registry research conducted by covered entities would require authorization.79 authorization may combine inclusion in the registry with participation in a given research study.80 on the other side, patient authorization is not required for covered entities to share information with public health as required by law.81 thus, providers need not seek patient authorization to report information to public health registries in a manner that is legally required. authorization is also not required for treatment, payment, or health care operations;82 thus registries maintained internally for purposes such as analysis of cost effectiveness do not require authorization. finally, information deidentified to hipaa standards is no longer considered health information 73. see 45 c.f.r. § 164.306(a)-(b) (2018). 74. see 45 c.f.r. § 164.308 (2018). 75. see 45 c.f.r. § 164.310 (2018). 76. see 45 c.f.r. § 164.312 (2018). 77. 45 c.f.r. § 164.524(a) (2018). this right extends only to information in the “designated record set” and excludes psychotherapy notes. id. 78. 45 c.f.r. § 164.526 (2018). 79. 45 c.f.r. § 164.508(a) (2018). 80. 45 c.f.r. § 164.508(b)(3) (2018). however, such compound authorizations must be careful to distinguish situations in which it is permissible to condition treatment on authorization and situations in which it is not. for example, receipt of treatment in a clinical trial may be conditioned on allowing data to be shared with the trial. however, treatment may not be conditioned on participation in a registry unless the registry is part of the trial. id. 81. 45 c.f.r. § 164.512(b)(1)(i) (2018). see office of the nat’l coordinator for health info. tech. permitted uses and disclosures: exchange for public health activities (2016), https://www.healthit.gov/sites/default/files/12072016_hipaa_and_public_ health_fact_sheet.pdf [https://perma.cc/62ew-gsq3]. 82. 45 c.f.r. § 164.502(a)(1)(ii) (2018). 58 indiana health law review [vol. 16:43 protected by hipaa;83 thus, information that has been de-identified before being transferred to registries is no longer considered to be under the strictures of hipaa. information may also be transferred and used without authorization if it has been partially de-identified in the form of what hipaa terms a “limited data set.”84 use of limited data sets requires a data use agreement to protect from reidentification. hipaa thus provides some fairly extensive protections for the health information it covers. to be sure, some of the exceptions to authorization, such as the exception for public health, have come under significant criticism from privacy advocates. however, the far greater concern is the amount of health information that is outside of the domain of hipaa. information in registries may never have been hipaa-protected because it was submitted by patients themselves or other entities that are not within the hipaa definition of a covered entity or business associate. information that was once hipaa-protected may also lose that protection if it is transferred to a registry that is not within the hipaa orbit. iv. fair information practices and data stewardship fair information practices (“fips”) were initially proposed over forty years ago with the advent of electronic data and have been honed over the ensuing years.85 this summary of fips is distilled from the initial report of the thendepartment of health, education, and welfare (“dhew”), the organization for economic co-operation and development (“oecd”) guidelines for privacy protection, and recommendations of the u.s. office of the national coordinator for health information technology (“onc”) and the national committee on vital and health statistics (“ncvhs”). fips were initially proposed in a report from dhew in 1973: “records, computers, and the rights of citizens.”86 the report, spawned by the growing recognition of the power of electronic data, rested on five key principles: (1) there must be no record-keeping systems whose very existence is private; (2) there must be a way for an individual to find out information about his own record and how it is being used; (3) there must be a way for the individual to prevent information about him that was obtained for one purpose from being used or made available for other purposes 83. 45 c.f.r. § 164.514(a) (2018). 84. 45 c.f.r. § 164.514(e) (2018). limited data sets may contain more specific location information and dates of treatment than de-identified information. id. 85. robert gellman, fair information practices: a basic history (2017), https://bobgellman.com/rg-docs/rg-fipshistory.pdf [https://perma.cc/j4mw-n6kg]. 86. willis h. ware et al., records, computers and the rights of citizens, xx-xi (1973), https://www.justice.gov/opcl/docs/rec-com-rights.pdf [https://perma.cc/29ku-s648]; see also s. rep. no. 93-1183, at 8-10 (1974). 2018] patient registries and their governance 59 without his consent; (4) there must be a way for an individual to correct or amend a record of identifiable information about him; and (5) any organization creating, maintaining, using or disseminating records of identifiable personal data must assure the reliability of the data for their intended use and must take precautions to prevent misuse of the data.87 in 1980, the oecd proposed a similar list of recommendations that subdivided several of the hew recommendations and also specified collection limitation, security protections, and accountability.88 the oecd principles included: (1) collection limitation; (2) data quality; (3) purpose specification; (4) use limitation; (5) security safeguards; (6) openness; (7) individual participation; and (8) accountability.89 these initial efforts to delineate fips placed robust emphasis on transparency, individual involvement, data integrity, and protections against data misuse. as health information has become managed in electronic forms that facilitate uses beyond the treatment of individual patients, the u.s. department of health and human services (“hhs”) has both encouraged electronic medical records and developed a variety of materials for promoting the privacy and security of the information these records contain. the onc within hhs is the primary federal entity responsible for health it and has published a range of “how to” materials for consumers and providers about health information privacy and security. onc has also attempted to provide guidance for the wide range of uses of health information now burgeoning across the electronic data landscape. for purposes of this article, one of the most important of these is the model privacy notice (“mpn”), originally issued in 2011 and updated in 2016 and 2018.90 the mpn is designed to be a standard form for health technology developers to use in disclosing their practices with respect to the collection of health information.91 if registries collect information through internet sites, as many now do, they will need to inform participants of their privacy policies. for registries that are outside of the scope of either hipaa or the common rule, from the perspective of federal law these policies need only comply with the ftc act’s prohibition of unfair or deceptive trade practices, as outlined in the previous section. the mpn is designed with these legal requirements in the background 87. ware, supra note 86, at xx-xxi. 88. oecd guidelines on the protection of privacy and transborder flows of personal data, org. econ. co-operation & dev. (sept. 23, 1980), http://www.oecd.org/sti/ieconomy/ oecdguidelinesontheprotectionofprivacyandtransborderflowsofpersonaldata.htm#recommendation [https://perma.cc/w2yv-xcaa]. 89. id. 90. model privacy note (mpn), healthit.gov, https://www.healthit.gov/topic/privacysecurity-and-hipaa/model-privacy-notice-mpn [https://perma.cc/wbz5-mm8h]. 91. off. of the nat’l coordinator for health info. tech., 2018 model privacy notice (2018), https://www.healthit.gov/sites/default/files/2018modelprivacynotice.pdf [https://perma.cc/r9le-9d9n]. 60 indiana health law review [vol. 16:43 and begins with a disclosure of whether the entity collecting the information is hipaa-covered.92 the mpn then prompts disclosure of how data are used internally, including whether the data will be used for scientific research or for the development of products.93 it also prompts disclosure of any external sharing of data, including whether it will be used for research, marketing, or development of products.94 importantly, it requires indicating to participants whether their data will be used or shared in identifiable form or only after it has been deidentified.95 it also requires informing participants of what other data may be combined with the information they submit, what participants may do with the data, what will happen in the case of a data breach, what will happen if participants decide to end their participation, and what will happen if the entity itself ceases operations.96 the federal advisory committee to hhs for vital and health statistics, the ncvhs, has also put forth a series of documents on data governance and stewardship. the ncvhs documents, built on fips, emphasize transparency and accountability in data governance.97 they present a number of concrete recommendations for parties responsible for data stewardship, including application of minimum necessary principles in data sharing and use and care in assuring that any data transfers are carefully monitored to assure that they occur as planned.98 they also recommend clear accountability and the development of mechanisms to both identify any failures, attach consequences to responsible parties, remediate any harms, and pursue needed corrective action.99 v. registry practices to ascertain the extent to which registries are guided by fair information practices and methods of data stewardship, the authors conducted telephone interviews with a selected group of registries. this section describes research methods and study results. the study was approved by the university of utah institutional review board and funded by the utah center for excellence in elsi research (“uceer”). the study was a pilot and represents at best a snapshot of practices of the registries contacted. nonetheless, it is clear that registry practices vary substantially and that at least some registries desire more specific guidelines about practices to use in managing the data they contain. 92. id. at 2. 93. id. 94. id. 95. id. 96. id. at 4. 97. nat’l comm. on vital & health statistics, health data stewardship: what, why, who, how: an ncvhs primer (2009), https://ncvhs.hhs.gov/wp-content/uploads/ 2014/05/090930lt.pdf [https://perma.cc/ug2z-xwgt]. 98. id. 99. id. 2018] patient registries and their governance 61 a. study methods to select registries for interview, the authors began with the registries and registry groups listed on the nih registry webpage.100 contact attempts were made for all registries listing contact information and collecting data longitudinally rather than at a single point in time, a total of fifty-nine registries. contact was initiated first with an email providing a brief background of the s.j. quinney college of law’s center for law and biomedical sciences and explaining the study objectives. contact was successfully made with thirty registries and interviews were ultimately conducted with twenty who agreed to discuss their registry’s practices; seventeen of these registries provided sufficient information to be used in the analysis that follows. population sizes vary across the registries contacted, from approximately 200 to over three-quarters of a million participants. disease types varied as well. registries were promised confidentiality and the discussion that follows reports only aggregate information or information in which no registries are identified. interviews were conducted by telephone by michael squires; they were not recorded but detailed notes were kept.101 the interviews followed a scripted questionnaire. the questionnaire was based on the authors’ review of the fips and registry governance materials outlined in the prior section. each section of the questionnaire was aimed at quickly identifying essential registry information. there were four main sections: (1) registry governance; (2) registry funding; (3) registry population and consent; and (4) data protection and privacy of registry participants. in all, the interviews provide a skeleton understanding of the registry landscape. some registries were reluctant to answer some of the questions due to liability concerns. some registries were also unable to answer the questions during the interview because the person contacted at the registry simply did not know the answer. some registries asked for findings to be shared with them to enable them to improve their practices. of particular note going forward, no registry was willing to agree to participate in a study that would involve registry participants and that might involve questions about participants’ knowledge about their participation in the registry, registry uses and protection of information, or other registry matters such as governance or financing. b. study findings this section reports study findings with respect to the four targeted questionnaire areas: governance, funding, registry populations, and privacy. 1. registry governance registry governance involves whether the registry has stated rules for its operations, how its decision-making is structured, and whether oversight mechanisms are in place. with respect to registry governance, the most consistent 100. list of registries, supra note 3. 101. notes are on file with the authors. 62 indiana health law review [vol. 16:43 finding was the great variety that exists. of the seventeen registries interviewed, fourteen had official statements of the registry mission. six had explicit bylaws, five had formal statements of the makeup of governance committees, and six had formal statements of their decision-making structures. fifteen of the seventeen had a formal management board; nine had advisory boards. statements of the duties of these governance structures varied widely as well. one registry specifically assigned fiscal responsibility to the management board, two used the board to advise on its strategic direction, and two used the board to review scientific reports and publications from the registry. for two registries, the board developed and monitored data practices, for another two the board created strategies for communication of registry activities, and for six the explicit role of the board was to consider the needs of all registry stakeholders. very few of the registries interviewed had formal or independent oversight mechanisms. only two of the seventeen had an independent oversight mechanism. six had internal oversight mechanisms, primarily composed of physicians. one identified an ethicist as a member of its oversight mechanism and two identified statisticians. although these data are perforce limited to the registries interviewed, the extent to which registries lack formal governance and accountability structures clearly warrants further study. registries may find that their success in enrolling patients and in generating patient trust is enhanced by more robust and transparent governance structures. 2. registry funding of the registries that agreed to be interviewed for this study, the predominant funding source was nih. several received ongoing support from academic medical centers after the expiration of the initial grant. one registry functioned largely on the basis of a grant from a single private donor. several received at least some funding or support from industry. several engaged in significant fundraising efforts to support their activities. the interviews did not yield sufficient information for analysis about the extent to which funding structures drove decisions about data acquisition, uses, and protections, although this is an area that clearly warrants more systematic investigation. 3. registry populations: enrollment, information, and consent to participate interviewees cited many factors as affecting registry size. the type of the disease and the frequency with which it occurs in the target population clearly constrains a registry’s potential population size. the method of acquiring registry participants also has an impact on the number of participants. most registries in this study used similar methods of identifying potential participants, including: (1) participating private clinics and physicians; (2) partnerships with universities with medical centers; and (3) website marketing by the registry itself. most registries identify potential registry participants through participating clinics and clinicians themselves. these are sometimes connected to private clinics, but a partnership with university medical centers is very common. 2018] patient registries and their governance 63 registries also invest in their own advertising to reach individuals themselves, often by hosting a website and advertising directly to potential registry participants. less common still are registries that advertise directly to potential registry participants by way of publication or brochure placed at a doctor’s office. all interviewed registries required some form of consent to initiate participation in the registry. for a majority of registry participants who are referred to a registry by a participating clinician or clinic, the process of enrollment and consent typically occurs within the treatment context. the likely process is that these potential participants will be approached by their clinician after a diagnosis of a condition of interest to the registry. for these patients, the consent process will take place with their physician and may also involve creating an online profile for contact and further consent to inclusion in future studies. the identity of registry participants is assured through their clinicians’ participation in the enrollment process. registries that recruit through direct advertising typically request the registry participant to provide the registry with personal health information. creating an online account and uploading medical reports and other information to the registry is the most usual method. typically included in that process are online registration consent forms. this process of enrollment may take place without the same kind of opportunity to ask questions that might occur for patients enrolled through the provider from whom they are obtaining treatment. it is also unlikely to involve a reliable method for assuring the identity of the registry participant. registries that permitted individuals to enroll and submit information themselves had very limited identity management structures in place; only one registry had a specific process for identity proofing and no registry required any kind of in person identity verification before participants could sign up for the registry. the longitudinal nature of many registries poses additional complications for participants’ consent to participation. many registries are devoted to conditions that become manifest by very early childhood; in such cases, participants are enrolled by their parents and may never become aware of their inclusion in the registry. even when participants were aware of their inclusion at the outset, they may lose touch with their participation in the registry and ultimately forget that their clinicians may nonetheless continue to update information about them in the registry. consent to registry participation, that is, may take place at a single point in time whereas registry participation is ongoing. some registries are structured to require new consent for participation in research sponsored by the registry, but others do not require renewed consent for research uses of the data contained in the registry. 4. data protection and privacy data protection and privacy are core to fips. questions in this portion of the questionnaire were the most numerous and likely the most difficult for registries to answer. indeed, many registries deferred answering a significant portion of the questions relating to the registry’s data protection policies from explicit liability concerns. registries also expressed concern that answering questions that touched on their registry privacy protocol would provide with too much information. 64 indiana health law review [vol. 16:43 many registries simply stated that they were unable to answer these questions about data protection and use. questions included the extent to which the registry made clear to participants the purposes for which information would be used and whether subsequent uses would be limited to the initial specified purposes. interviews also asked whether there was clarity about who would have access to the data, including whether participants would have access to data about themselves. when participants submit data themselves, they presumably are aware they are making the submission, at least at the time it occurs. when clinicians supply data to the registry, however, patients may not have the opportunity to know what data has been submitted and to request correction of any errors. findings from the interviews were that twelve registries specify the purpose for which data are being collected. none indicated explicit policies about letting participants obtain a copy of information about them in the registry or suggest corrections for this information in the registry. six had explicit use limitation requirements. seven limited access to registry data to specific registry personnel. five registries allowed data to be shared with external organizations—but none of these had a data use agreement they were willing to share. security practices were also an area of concern raised in the interviews. four registries had explicit data security practices and set a minimum standard of care for data security protection. no registries had adopted breach notification processes and no registries reported awareness of any data breaches. vi. recommendations and conclusion as this snapshot may indicate, registries vary widely with respect to the extent to which they have explicit policies that reflect the core values of fips and data stewardship. the interview data are limited, however, and must be viewed with the caution that they may reflect an unwillingness to share information about policies rather than the lack of policies. it is also fair to say that some of the larger and more established registries were among the ones with more extensive data management and protection policies, but this generalization did not always hold. nonetheless, the interview findings give significant reason for concern. registries may be more enthusiastic collectors of information than they are protectors of it. if so, at least some registries would appear to be at significant risk of experiencing problems with their use and protection of information—problems that could undermine trust and participation in the registry enterprise. registries should be encouraged, at a minimum, to develop governance and oversight plans.102 they should develop explicit policies for specifying the purposes of data collection and limitations on data use. data use agreements should be developed and enforced whenever registry data are made available to entities outside of the registry. security risk assessments are also imperative for many registries. transparency about registry policies and data uses are also essential. transparency should also include allowing registry participants to know what 102. agency for healthcare research & quality, supra note 1. 2018] patient registries and their governance 65 information the registry holds about them and to suggest any needed corrections. regular communication with registry participants—for example, in the form of an electronically available annual report—could greatly enhance awareness of registry activities for participants. these measures have the potential to enhance trust among registry participants and encourage engagement with the registry. registries are a growing part of the health information landscape and an important source of information, particularly about rare conditions. further research on registry practices and on the attitudes and experiences of registry participants is needed both to reduce risks for participants and to further registry development. a tribute to eleanor dearman kinney indiana health law review volume xvii 2020 number 1 a tribute to eleanor d. kinney introduction robert katz* this issue of the indiana health law review celebrates the scholarly achievements of eleanor dearman kinney, who passed away on november 16, 2018, at the age of 71, her life cut short by illness. it consists of articles written by scholars who engage professor kinney’s ideas and concerns. in 1984 professor kinney joined the faculty of the indiana university robert h. mckinney school of law.1 she came ready to do great things, having earned her bachelor of arts and juris doctorate from duke university, a master of arts from the university of chicago, and a master of public health from the university of north carolina. she came armed with practical wisdom she gleaned from working at the u.s. department of health and human services, the american hospital association, duke university medical center, and in private practice. professor kinney, who retired in 2011, had a lasting impact on iu mckinney. she served as founding executive director of its internationally recognized william s. and christine s. hall center for law and health, which was established in 1987.2 professor kinney “helped educate and mentor two generations of indiana healthcare lawyers,” writes william h. thompson, a former student and colleague, who expresses deep gratitude for her guidance and vision. professor nicolas terry, professor kinney’s successor as the hall center’s executive director, surveys her many contributions to the school of law and to health law scholarship in “standing on the shoulders of a giant.” professor kinney authored or co-authored more than seventy-five journal articles during her thirty-five years in the academy and into her remarkably productive retirement—or “dotage” as she mischievously called it. two of these articles appeared in this publication, whose establishment in 2003 she inspired and facilitated. she also published seven articles with the indiana law review. susan david demaine’s “works of eleanor d. kinney” carefully catalogs her published works and encapsulates key themes. professor kinney was a leading exponent of the idea of health care as a * professor of law, indiana university robert h. mckinney school of law. a.b., 1987, harvard university; j.d., 1992, the university of chicago school of law. 1. formerly known as the indiana university school of law indianapolis. 2. formerly known as the center for law and health. 2 indiana health law review [vol. 17:1 human right. her contributions to this field are lovingly detailed in these pages by benjamin mason meier and lance gable in “advancing the human right to health: eleanor kinney’s seminal contributions to the development and implementation of human rights for public health.” “in reflecting on her legacy,” write meier and gable: we recognize her enduring contributions to the intersection of health law and human rights, which were not only ahead of her time in understanding the importance of international law, but also continue to have relevance in these uncertain times for the realization of health and human rights in the united states. professor r. george wright, a colleague of professor kinney, writes that “[r]ather like a gemologist, professor kinney examined the facets of th[e human] right [to health care] with discerning attention.” he then proceeds to mine this rich vein. professor kinney favored “an updated natural-law based approach” to justify claims of a human right to health care. this approach is audacious, he explains, because “[c]ontemporary culture tends to view natural law theories of any political valence as unpersuasive, incredible, or realistically unavailable.” even so, developing the foundations of such an approach “if possible, is a worthy task.” hope requires audacity, and eleanor kinney had both. one can espouse a human right to health care without completely theorizing its basis. yet even a rights skeptic might assert such a right in order to mobilize political support for proposals to expand access to health care. in “seize the moment: the opportunity to realize the human right to healthcare in the united states,” professor fran quigley, another colleague of professor kinney’s, declares that enacting “medicare for all” would “fulfill eleanor kinney’s lifelong quest to see healthcare become a realized human right” in the u.s. there is something thrilling about seeking the realization of a human right as compared to a right not characterized as such, much less of an interest or preference. professor quigley believes that “we may finally be on the cusp of change” for health care in the united states. european countries may be moving in the opposite direction, reports elisavet athanasia alexiadou, a lawyer who researches health and human rights law, in “health care reforms and the challenge of inequality from a human rights lens: lessons from europe.” if true, this movement is ironic because, as alexiadou states, all european union countries “are parties to at least one legally binding human rights treaty which guarantees a right to health (care) for every individual.” even so, “europe seems to be moving away from the language of human rights commitments, and particularly of [a] right to health commitment, to one of technical inputs and efficiency gains.” this movement is driven by the imperatives of government austerity and socioeconomic inequality. it may also reflect disenchantment with the elusive task of tailoring an abstract right to the demands of a given situation. are europeans also obliged to enact medicare for all? “[i]t must be conceded,” concedes alexiadou, “that human rights standards do not provide easy solutions on health care reform choices.” some of professor kinney’s scholarship helped pave the way for improvements in health care quality. in [title], longtime colleague professor 2020] introduction 3 barry r. furrow explains how an influential article co-authored by professor kinney offered a potential future for “medicare as a quality promoter through the use of medicare’s quality improvement organizations (“qios”).” her research on community-based long-term care provide models for improving such care, as rachel zuraw and tara sklar explain in “digital health privacy and age: quality and safety improvement in long-term-care.” professor kinney was also an early champion of empirical health law scholarship, as professor ross silverman recounts in “a cross-disciplinary giant at the crossroads of america.” that the present contributors are moved to “engage, deeply, generously, and thoughtfully”3 with professor kinney’s ideas is yet another testament to her achievement. her conviction that a human rights approach to health care could help alleviate human suffering was of a piece with her faith in a beneficent ultimate reality. may her memory be a blessing. 3. this formulation comes from ashley j. bohrer, marxism and intersectionality: race, gender, class and sexuality 22 (2019). structural racism in housing in indianapolis florence wagman roisman* “[n]ow arise political extremism, white supremacy, domestic terrorism that we must confront and we will defeat . . . . we face an attack on our democracy and on truth. a raging virus, growing inequity, the sting of systemic racism, a climate in crisis.”1 “structural racism” is a newly popular term but a long-standing problem. it has been defined as “the policies, programs, and practices of public and private institutions that result in greater rates of poverty, dispossession, criminalization, illness, and ultimately mortality of african americans. most importantly, it is the outcome that matters, not the intentions of the individuals involved.”2 in no field of human activity is structural racism more significant, more consequential, than in housing. with housing, indeed, we literally see the structures – and the land use patterns – that have been produced by structural racism. and because housing and land use patterns are so concrete and longlasting, we in the 21st century experience the impact of structural racism from past centuries as well as what is occurring today. the reality in the indianapolis metropolitan area is that it – like most major metropolitan areas in the u.s. – is pervasively segregated on the basis of race, with most african americans in particular living in under-resourced * william f. harvey professor of law and chancellor’s professor, indiana university robert h. mckinney school of law. i am grateful to mollie golden, j.d. and george sorrells (j.d. expected 2022) for superb research assistance, as well as professor rena seidler of the ruth lilly law library for her essential help. i also am grateful to the indiana land title association (“ilta”), and ilta president kurt laker ’04, and to the central indiana community foundation (“cicf”) for inviting me to speak; my keynote speech at the ilta annual meeting in september 2020 was the basis for this article and the cicf talk was the foundation for that. i thank the indiana health law review for inviting me to speak at the symposium in october 2020, where i made some of these points and the additional point that white people are deeply harmed by white supremacy. see jonathan m. metzl, dying of whiteness: how the politics of racial resentment is killing america’s heartland (2019). any errors of course are my responsibility alone. i thank the editors of the indiana health law review for their scrupulously careful and helpful editing. i dedicate this article to the memory of john and julie riordan coburn, grandparents of my grandchildren; john and julie both powerfully believed in the dignity and worth of all human beings. 1. joseph r. biden, jr., president of the united states, inaugural address (jan. 20, 2021). 2. keeanga-yamahtta taylor, from #blacklivesmatter to black liberation 8 (2016) (crediting stokely carmichael and charles hamilton with coining the phrase “institutional racism,” which is said to be synonymous with “structural racism”); stokely carmichael & charles v. hamilton, black power: the politics of liberation in america 5-7 (1967). pertinently, carmichael and hamilton write: “institutional racism relies on the active and pervasive operation of anti-black attitudes and practices. a sense of superior group position prevails: whites are ‘better’ than blacks; therefore[,] blacks should be subordinated to whites.” id. at 5. 356 indiana health law review [vol. 18:355 neighborhoods isolated from white people and the amenities associated with white neighborhoods – good schools; healthy, safe, and pleasant environments; varied employment opportunities; inviting recreational facilities. the indianapolis metropolitan statistical area (“msa”) has been and continues to be one of the most segregated in the u.s. although segregation did decrease significantly after 2000, it still is at a very high level – 64.4%.3 in 1971, u.s. district judge samuel hugh dillin, deciding a school desegregation case brought by the u.s. against the city of indianapolis and the indianapolis school board, wrote that the indianapolis msa “includes, in addition to marion county, the contiguous counties of boone, hamilton, hancock, hendricks, johnson, morgan, and shelby.”4 the 1970 census showed the black population of those seven counties to be 0.897%.5 today, the black population of those counties is, in decreasing order: • 5.96% for hendricks – which has the highest percentage; • 3% for hamilton; • 2.9% for hancock; • 1% for johnson; • 1% for shelby; • less than 1% for boone; and • 0.5% for morgan.6 residential racial segregation is coordinated with economic segregation, so that most african americans and other people of color live in neighborhoods characterized by high poverty as well as poor schools, poor employment opportunities, and unhealthy and unsafe environments.7 3. residential segregation data for u.s. metro areas, governing, https://www.governing. com/archive/residential-racial-segregation-metro-areas.html [https://perma.cc/w8b3-kmkr] (last visited apr. 10, 2021) (explaining that the dissimilarity index was the primary metric used and the data used the u.s. census bureau’s 2013-2017 american community survey). 4. united states v. bd. of sch. comm’rs of indianapolis, 332 f. supp. 655, 663 (s.d. ind. 1971). 5. id. the black population of the indianapolis metropolitan statistical area in 1970 was 2,849 of a total population of 317,583. id. 6. the african american population of the indianapolis msa in 2019 was 330,987. indianapolis – carmel – anderson, city population, https://www.citypopulation.de/en/usa/metro/ 26900__indianapolis_carmel_a/ [https://perma.cc/yyg6-5hl7] (last visited feb. 28, 2021). 7. richard b. pierce, polite protest: the political economy of race in indianapolis 1920-1970, at 84 (2005) (stating that a notre dame professor’s study concluded that: “by the late 1960s, whites no longer needed racial covenants and neighborhood associations to block african-american movement into white neighborhoods. the economic gap between whites and african-americans had grown sufficiently that economic realities provided the most effective barrier”); nikole hannah-jones, what is owed, n.y. times mag. (june 24, 2020), https://www. nytimes.com/interactive/2020/06/24/magazine/reparations-slavery.html [https://perma.cc/3qwwf43p] (stating that “in a country where black people have been kept disproportionately poor and prevented from building wealth, rules and policies involving money can be nearly as effective for maintaining the color line as legal segregation. you do not have to have laws forcing segregated 2021] structural racism in housing in indianapolis 357 the harms caused by residential racial segregation are many and deep. one might think that climate change, or gun violence, or police brutality, or extreme political polarization, is our most serious domestic problem. all these are serious problems, and all are caused in substantial part by residential racial segregation.8 the principal causes of residential racial segregation have been public policies at the federal, state, and local levels. many such policies continue today. these principal causes are eight: (1) racial zoning; (2) racial covenants; (3) the home owners loan corporation (“holc”)/federal housing administration (“fha”)/ and veterans administration (“va”) homeownership programs; (4) public housing; (5) urban renewal; (6) federal aid highways; (7) euclidean zoning; and (8) the administration of the lihtc and voucher programs. in addition to these policies, as judge dillin found: negroes were discouraged from purchasing homes in predominantly “white” neighborhoods by various methods: white realtors refused to show such homes to negroes (and no negro real estate broker was permitted to become a member of the indianapolis real estate association until 1962), a two-price system was used: a realistic market price to whites and a ridiculously inflated price to negroes, lending institutions refused to finance homes sought to be purchased by negroes in ‘white’ areas. those pioneering negroes who nevertheless overcame all obstacles and succeeded in purchasing such a home were then harassed by such devices as threatening and obscene telephone calls, stones hurled through windows, neighborhood ostracism, etc. certain streets and other landmarks, such as fall creek, white river, certain railroad tracks, etc., were regarded at different times as barriers to be hurdled by negroes at their peril.9 i briefly discuss below each of these eight and some actions we should take, as individual citizens, as leaders in our communities, and as real estate professionals, to undo and redress some of the harms caused by these policies. housing and schools if white americans, using their generational wealth and higher incomes, can simply buy their way into expensive enclaves with exclusive public schools that are out of the price range of most black americans”). 8. see, e.g., metzl, supra note * (showing how white supremacy has led to increased gun violence and decreased health and education services); richard rothstein, the color of law: a forgotten history of how our government segregated america 195-96 (2017) (discussing residential racial segregation as a cause of political polarization). 9. bd. of sch. comm’rs of indianapolis, 332 f. supp. at 662 (footnote omitted). 358 indiana health law review [vol. 18:355 1. racial zoning beginning toward the end of the 19th century, a number of cities and states enacted explicit racial zoning ordinances and statutes that required that persons of certain “races” reside only in particular – and particularly undesirable – parts of town. this racial zoning was directed especially against people of asian descent on the west coast and against african americans throughout the country.10 in 1917, the u.s. supreme court held such explicit racial zoning unconstitutional.11 nonetheless, communities continued to enact and enforce such laws. indianapolis enacted such a law in 1926.12 the u.s. supreme court continued to invalidate those laws, but the laws stayed on the books and were adhered to in many communities nonetheless.13 10. with respect to persons of asian descent, see, for example, in re lee sing, 43 f. 359 (n.d. cal. 1890); alexander saxton, the indispensable enemy: labor and the antichinese movement in california 257 (1971); charles j. mcclain, in search of equality: the chinese struggle against discrimination in nineteenth-century america 282-83 (1996); roger daniels, the politics of prejudice: the anti-japanese movement in california and the struggle for japanese exclusion 18-22 (1962). with respect to african americans and others, see garrett power, apartheid baltimore style: the residential segregation ordinances of 1910-1913, 42 md. l. rev. 289 (1983); richard r.w. brooks & carol m. rose, saving the neighborhood: racially restrictive covenants, law, and social norms (2013). 11. buchanan v. warley, 245 u.s. 60 (1917). 12. bd. of sch. comm’rs of indianapolis, 332 f. supp. at 662. 13. see, e.g., tyler v. harmon, 273 u.s. 668 (1927) (new orleans); city of richmond v. deans, 281 u.s. 704 (1930); city of birmingham v. monk, 185 f.2d 859 (5th cir. 1950), cert. denied, 341 u.s. 940 (1951). 2021] structural racism in housing in indianapolis 359 2. racial covenants although racial covenants also date from the 19th century, they became particularly widely used as explicit racial zoning laws were invalidated.14 they are common in indianapolis. as judge dillin noted in his 1971 opinion, “many of the better known subdivisions, such as williams creek estates, broadmoor estates, meridian hills, highwoods addition, forest hills, wellington estates, fall creek highlands, greenslopes, wynedale, ellenberger plaza, and meridiankessler terrace, contained such covenants.”15 the u.s. supreme court held the covenants judicially unenforceable in 1948 and in 1968 the covenants became unlawful under the federal fair housing act, which prohibited statements indicating a preference based on race, color, religion, or national origin; the act subsequently was amended in 1974 and 1988 to extend this prohibition to sex, disability, and familial status.16 despite their unenforceability and illegality, racial and other discriminatory covenants were produced even after these rulings and statutes, and generally the covenants continue to appear in deeds throughout the country. we know of several relatively recent instances in which people have tried to enforce them – a racial covenant in virginia, a national origin covenant in new york, a religious covenant in michigan.17 14. brooks & rose, supra note 10, at 46; clement e. vose, caucasians only: the supreme court, the naacp, and the restrictive covenant cases 9 (1959). 15. bd. of sch. comm’rs of indianapolis, 332 f. supp. at 662. 16. shelley v. kraemer, 334 u.s. 1 (1948) (invalidating judicial enforcement of racial covenants); hurd v. hodge, 334 u.s. 24 (1948) (invalidating judicial enforcement of racial covenants); mayers v. ridley, 465 f.2d 630 (d.c. cir. 1972) (en banc) (holding racial covenants invalid under 42 u.s.c. section 3604(c)). the fair housing act was amended in 1974 to prohibit discrimination because of sex and in 1988 to prohibit discrimination because of “handicap,” now called “disability,” and familial status. housing and community development act of 1974, pub. l. no. 93-383, § 808(b), 88 stat. 633, 729; fair housing amendments act of 1988, pub. l. no. 100-430, 102 stat. 1619, 1619-39; see robert g. schwemm, housing discrimination: law and litigation §§ 11c:1, 5.3 (2017). covenants often restricted ownership and occupancy not only against blacks but also against “indians, jews, chinese, japanese, mexicans, hawaiians, puerto ricans, and filipinos, among others.” shelley, 334 u.s. at 21 (1948). 17. motoko rich, restrictive covenants stubbornly stay on the books, n.y. times (apr. 21, 2005), https://www.nytimes.com/2005/04/21/garden/restrictive-covenants-stubbornly-stay-on-thebooks.html [https://perma.cc/9u3y-fehk] (reporting a conversation “three years ago” and a homeowner’s testimony to the virginia fair housing board that he believed a clause in his deed prohibited him from selling to “any person not of the caucasian race”); the associated press, national briefing/south: virginia man must pay for housing discrimination, n.y. times (dec. 10, 2005), https://www.nytimes.com/2005/12/10/us/national-briefing-south-virginia-man-must-payfor-housing-discrimination.html [https://perma.cc/77nm-t2u7]; josh russell, settlement ends nazi-era ‘whites only’ enclave in new york, courthouse news serv. (may 17, 2017), https://www.courthousenews.com/settlement-ends-nazi-era-whites-enclave-new-york 360 indiana health law review [vol. 18:355 3. holc/fha/va with the great depression, the federal government began to act to protect and encourage homeownership. the home owners loan corporation created the residential security maps that nationalized the practice of “redlining” neighborhoods in which african americans and other people of color lived.18 the fha and va made it possible for working americans to afford homeownership, which previously had been too expensive for them. the fha created long-term, low-interest, low-down-payment, fully amortized mortgage lending insured by the federal government, and the va reproduced this with guarantees rather than insurance. but the devil in both programs was that the loans were available almost exclusively to whites, and only for housing in racially exclusive developments.19 between 1946 and 1959, 98% of the funding for the fha and va homeownership programs went to whites.20 homeownership became the american dream because of these federal programs, but the federal programs – even the gi bill – benefitted whites, not people of color, and insisted on racially exclusionary communities.21 [https://perma.cc/d3bz-2ltr] (settling litigation challenging a subdivision that “remains a white enclave by ‘enforcing a number of rules that restrict homeownership to members who are required primarily to be individuals of german extraction’”). in michigan, a 2017 lawsuit challenged a covenant that excluded from a subdivision all persons who were not christians. see john agar, christian requirement at northern michigan resort illegal, federal government says, grand rapids news (july 10, 2019), https://www.mlive.com/news/grand-rapids/2019/07/christianreq u ir em en t -a t -n or th e rn-mich igan-resort-illegal-federal-government-says.h tml [https://perma.cc/db28-x5la]. covenants also attained much public attention in the confirmation hearings for justice william rehnquist in 1986 and the california senate contest between diane feinstein and michael huffington in 1998, as each of these individuals owned homes with racial covenants. see brooks & rose, supra note 10, at 1; florence wagman roisman, the lessons of american apartheid: the necessity and means of promoting residential racial integration, 81 iowa l. rev. 479, 494 n.73, 494-95 (1995). 18. kenneth t. jackson, crabgrass frontier: the suburbanization of the united states 199 (1985). 19. id. at 203-18, 233. 20. mark i. gelfand, a nation of cities: the federal government and urban america 1933-1965, at 221 (1975). in the ilta speech, i gave these dates as 1933 to 1960; i regret and apologize for this error. 21. see rothstein, supra note 8, at 180-83. 2021] structural racism in housing in indianapolis 361 4. public housing again, in indianapolis as elsewhere in the u.s., public housing sites were chosen and tenants selected to enforce residential racial segregation.22 the first public housing project in the city was lockefield gardens, which was constructed for black families. its 784 units were built in what was called “the worst negro slum in america.”23 in the school desegregation case, the district court found, and the u.s. court of appeals for the seventh circuit affirmed, that the sites for the other ten public housing projects all were chosen by the housing authority of the city of indianapolis to be within the boundaries of the old city of indianapolis – that is, within the boundaries of indianapolis public schools (“ips”) – and that this was done with the unconstitutional intent on the part of the responsible state agencies to impose residential racial segregation.24 in the projects that housed families, 98% of the residents were black.25 the ten projects comprised units for more than 1,600 families and, as the court of appeals noted, “once a public housing project was opened other blacks tended to settle in the area.”26 “the connection between that policy and suburban housing and school enrollment patterns is obvious,” the court of appeals said.27 22. pierce, supra note 7, at 63 (explaining that public housing was used “to help maintain racially separate neighborhoods”). 23. id. at 64 (quoting nathan straus, former u.s. housing administrator). pierce also says that public housing “reserved for whites” was located at less dense, scattered sites. id. at 64-65. 24. united states v. bd. of sch. comm’rs of indianapolis, 37 f.2d 1101, 1111 (7th cir. 1980). 25. id. at 1109. 26. id. at 1114. 27. id. 362 indiana health law review [vol. 18:355 5. urban renewal and 6. highways urban renewal and highways really can be discussed together. again, in indianapolis as elsewhere throughout the u.s., both were used to destroy housing – most of it occupied by african americans – and vibrant communities. homeowners were accorded very small compensation for their homes; tenants were given no compensation, no relocation assistance, and no replacement housing other than sometimes the offer of a public housing unit.28 the expansion of indiana university-purdue university indianapolis and the downtown hospitals, the revitalization of the downtown canal, all were part of this program.29 the later development of fall creek replicated the problems of the earlier urban renewal.30 urban renewal was known as “negro removal” – for excellent reasons – and the federal aid highway program had the same effect.31 28. see rothstein, supra note 8, at 189. with regard to highways, see, for example, mark rose & raymond mohl, interstate highway politics and policy since 1939 (2012). 29. see, e.g., wildstyle paschall, indiana avenue: the ethnic cleansing of black indianapolis, new am. (feb. 4, 2020), https://www.newamerica.org/indianapolis/blog/indianaavenue-ethnic-cleansing-black-indianapolis/ [https://perma.cc/c368-bc8b]; sarah bowman, the white river: boundaries of ‘redlining’ maps still etched in indianapolis neighborhoods, indianapolis star (may 2, 2020), https://www.indystar.com/in-depth/news/environment/2020/05/ 02/redlined-indianapolis-areas-still-see-poverty-poor-health/3017810001/ [https://perma.cc/3mnyrjks]. 30. matt nowlin et al., neighborhood change 1970-2016: suburbanization, gentrification, and suburban redevelopment 5 (2018), https://www.savi.org/wp-content/ uploads/2017/10/neighborhood-change-savi-community-trends.pdf [https://perma.cc/vc45wvyb]. 31. in 1963, james baldwin during an interview with kenneth clark stated that urban renewal means negro removal and that “the federal government is an accomplice to this fact.” to view part of this interview, see vince graham, urban renewal...means negro removal. ~ james baldwin (1963), youtube, https://www.youtube.com/watch?v=t8abhj17kyu (last visited apr. 10, 2021). barak atiram, the wretched of eminent domain: holdouts, free-riding and the overshadowed problem of blinded-riders, berkeley j. afr.-am. l. & pol’y 52, 86 (2016); wendell e. pritchett, the “public menace” of blight: urban renewal and the private uses of eminent domain, 21 yale l. & pol’y rev. 1, 47 (2003) (noting that “urban renewal came to be known as ‘negro removal’”). 2021] structural racism in housing in indianapolis 363 7. euclidean zoning we come now to some of the most important, continuing programs imposing residential racial segregation in indianapolis. when explicit racial zoning was invalidated by the u.s. supreme court (and a number of state courts), local communities turned to the “use” zoning that we know today to achieve the same purposes without employing the language of racial exclusion.32 this is the zoning that controls land use today, reserving vast areas of the suburbs for single-family housing on relatively large lots and excluding from those suburbs any multifamily or clustered housing that would serve families rather than elderly persons. subsidized housing of any kind – if it is for families and not seniors – is almost entirely excluded from the suburbs. this goes far to explain the very low percentage of african americans who live in the suburbs.33 32. taylor, supra note 2, at 114-15; rothstein, supra note 8, at 48-57, 204-05; florence wagman roisman, opening the suburbs to racial integration: lessons for the 21st century, 23 w. new eng. l. rev. 65, 94 (2001); christopher silver, the racial origins of zoning in american cities, in urban planning and the african american community: in the shadows 21 (june manning thomas & marsha ritzdorf eds., 1997). 33. see, e.g., kaitlin lange, carmel has a negative reputation when it comes to race relations. here’s why., indianapolis star (july 12, 2020), https://www.indystar.com/story/news/ local/hamilton-county/carmel/2020/07/12/carmel-negative-reputation-race-relations/3236395001/ [https://perma.cc/dag5-5nnv]; travis robinson, carmel students say they face racism as group pushes for change, wishtv (aug. 30, 2020), https://www.wishtv.com/news/localnews/carmel-students-say-they-face-racism-as-group-pushes-for-change/ [https://perma.cc/xm6mb8kh]; casey kensley, hamilton county begins to reconcile a shameful klan past, indianapolis monthly (june 11, 2020), https://www.indianapolismonthly.com/longform/ hamilton-county-begins-to-reconcile-a-shameful-klan-past [https://perma.cc/j5k5-nvt7]; brook kemp & justin mack, controversial lyrics raise calls of racism during dance performance for noblesville duck race, indianapolis star (july 26, 2020), https://www.indystar.com/story/news/ local/hamilton-county/2020/07/26/lyrics-during-dance-performance-noblesville-indiana-stircomplaints-racism/5515426002/ [https://perma.cc/h5gt-rbdt]. 364 indiana health law review [vol. 18:355 8. the administration of the low income housing tax credit (“lihtc”) and voucher programs the final item on my list also is a double bill – the administration of the lihtc and voucher programs. these are two of the three major federal housing subsidy programs, the third being the conventional public housing program, which produces no new units but in fact suffers significant reductions of housing stock each year.34 the lihtc program is the largest federal program for producing new or substantially rehabilitated subsidized housing, and the voucher program assists millions of households by enabling them to pay approximately 30% of household income for rent with the federal government paying the difference between that and a payment standard established by the government.35 the programs are related because lihtc units, despite the program’s name, are not designed to accommodate really poor people – this is a shallow subsidy program.36 lihtc works for poor people only if they have vouchers.37 and federal law prohibits lihtc developments from discriminating against voucher holders because they have vouchers.38 these programs have potential for enabling residential racial desegregation, except for three facts: (1) local communities usually zone out multifamily housing, particularly if it is for families and most particularly if it is subsidized;39 (2) the state and private actors who control the location of lihtc developments put virtually all the family developments into areas that already are predominantly minority, high poverty, inner-city areas;40 and (3) federal law allows private landlords, other than lihtc 34. for information on lihtc, see nat’l low income hous. coal., advocates’ guide 2020, at 5-17 (2020). for information on vouchers, see id. at 4-1. for information on public housing, see id. at 4-30. 35. u.s. dep’t of hous. & urban dev., what happens to low-income housing tax credit properties at year 15 and beyond? 2 (2012), https://www.huduser.gov/portal// publications/pdf/what_happens_lihtc_v2.pdf [https://perma.cc/w7zs-a4sq]; housing choice vouchers fact sheet, u.s. dep’t housing & urb. dev., https://www.hud.gov/topics/housing_ choice_voucher_program_section_8 [https://perma.cc/s7qe-ftpw] (last visited may 7, 2021). 36. u.s. dep't of hous. & urban dev., supra note 35, at 3-4. 37. id. at 3 (“[t]he program reaches a somewhat higher income group than previous production programs, unless it is coupled with other subsidies such as tenant-based housing vouchers.”). 38. 42 u.s.c. § 12745(a)(1)(d) (2021). 39. richard a. epstein, positive and negative externalities in real estate development, 102 minn. l. rev. 1493, 1524 (2018) (“[i]t is certain that local governments will use all the resources at their disposal to keep out low-income families, often . . . families with school-age children.”). 40. see rothstein, supra note 8, at 190. 2021] structural racism in housing in indianapolis 365 developments, to refuse to accept voucher holders as tenants.41 a number of other states prohibit this kind of discrimination, which is based on stereotypes about voucher holders, but such discrimination is not prohibited in indiana.42 41. id. at 190-91, 210 (pointing out also that fair market rent levels are too low to allow vouchers to be used in well-resourced neighborhoods). 42. see poverty & race research action council, expanding choice: practical strategies for building a successful housing mobility program (2021), https://www. prrac.org/pdf/appendixb.pdf [https://perma.cc/qe34-fq3d]. 366 indiana health law review [vol. 18:355 what can we all do? as i have said, residential racial segregation is, in my view, the most serious problem in the u.s. today. the most important task for all of us – as citizens, as parents and grandparents, as lawyers, and as real estate professionals – is to reduce this segregation, discrimination, inequality, and separation. i suggest four kinds of actions we can take. first, keep educating yourselves and your friends and neighbors about the sources, history, and evils of residential racial segregation. i have been teaching about them for fifty years, and students always say they are shocked that they had not learned about much of this before law school. an excellent place to start is with richard rothstein’s book, the color of law: a forgotten history of how our government segregated america.43 try to learn also from people. white people tend to associate mostly with other white people. try to expand your horizons. talk to people of color with whom you share interests in work or religion or sports.44 second, get involved in community anti-racist activities. several suburban communities experienced serious racist incidents within the past few months – i think of carmel and noblesville, in particular.45 when such things happen in your community, speak and act for inclusion. encourage multi-racial conversations of many kinds. encourage open housing activities. third, you might promote political action on the local, state, or federal level. locally, inclusive zoning would be a wonderful innovation. montgomery county, maryland, a suburb of washington, d.c., pioneered this in 1974, and many localities all over the country have emulated it. local zoning laws require that some percentage – 15% to 30% – of all new developments be subsidized units. studies have shown this to be very successful in integrating housing and schools, with great benefits for all involved.46 43. rothstein, supra note 8. it is particularly important to educate young people – those in middle school, high school, and college. see id. at 199-200; james w. loewen, lies my teacher told me: everything your american history textbook got wrong (1995); florence wagman roisman, lessons for advocacy from the life and legacy of the reverend doctor pauli murray, 20 u. md. l.j. race relig. gender & class 1, 29-33 (2020); isabel wilkerson, caste (2020); ibram x. kendi, how to be an anti-racist (2019); robin diangelo, white fragility (2018); jon meacham, his truth is marching on (2020). one also would do well to read works by james baldwin and toni morrison, among many others. 44. see susan nieman, learning from the germans 67 (2019) (discussing “the idea that when people tell their stories, you can always find something that is yours too, and then they’re not strangers anymore. i’ve seen it happen with people who initially refused to look at each other”). 45. see lange, supra note 33; robinson, supra note 33; kensley, supra note 33; kemp & mack, supra note 33. 46. rothstein, supra note 8, at 205; heather schwartz, housing policy is school policy: economically integrative housing promotes academic success in montgomery county, maryland (2010). unfortunately, the indiana general assembly has prohibited such 2021] structural racism in housing in indianapolis 367 in a similar vein, local communities should welcome family lihtc developments, and the indiana state housing finance authority should amend its annual qualified allocation plan to encourage the development of family units in well-served suburban neighborhoods with good schools, safe streets, and heathy environments.47 both local governments and the state should prohibit discrimination against voucher holders and provide incentives to landlords who do rent to voucher holders.48 nationally, the government should encourage expansion of the lihtc and voucher programs. in fact, senator young has cosponsored a bill that would improve and expand the voucher program; i am sure he would welcome hoosier support.49 for every four families in need of and eligible for housing assistance before the pandemic began, only one family received housing assistance – one in four, before the pandemic.50 now, with millions of households having lost their jobs and facing loss of their homes, the need for further income and housing assistance is enormously greater.51 fourth, and finally: take action with respect to racially restrictive covenants. although they were made judicially unenforceable in 1948 and illegal in 1968, they still are in many deeds in indianapolis and elsewhere.52 what should be done about these covenants? about a dozen states have enacted legislation to make it easier and less expensive to eliminate them from deeds.53 since the covenants plainly are illegal under the 1968 federal fair housing act, and have been held to be illegal under that statute, another local legislation. ind. code § 32-31-1-20 (2020). this state law should be reversed. 47. katie whitley, increasing access to high-quality schools in indianapolis through the low-income housing tax credit qualified allocation plan, 55 ind. l. rev. (forthcoming 2021). 48. rothstein, supra note 8, at 208-09. rothstein also points to illinois’s allowance of a property tax deduction for landlords who rent to voucher holders. id. at 210. 49. see press release, young and van hollen introduce bipartisan bill to increase mobility, keep families together, and move children to areas of opportunity (dec. 18, 2019), https://www.young.senate.gov/newsroom/press-releases/young-and-van-hollen-introducebipartisan-bill-to-increase-mobility-keep-families-together-and-move-children-to-areas-ofopportunity [https://perma.cc/p4yr-gg7r]. senator todd young and maryland senator chris van hollen have sponsored the family stability and opportunity vouchers act, which champions an additional 500,000 housing vouchers over five years for low-income, high-need families with young children to provide supports for families to move to high-opportunity areas to increase successful life outcomes. family stability and opportunity vouchers act of 2019, s. 3083, 116th cong. (2019). 50. nat’l low income hous. coal., supra note 34, at 1-11. 51. tracking the covid-19 recession’s effects on food, housing, and employment hardships, ctr. on budget & pol’y priorities (may 7, 2021), https://www.cbpp.org/research/ poverty-and-inequality/tracking-the-covid-19-recessions-effects-on-food-housing-and [https://perma.cc/2p44-ypzn]. 52. see supra section 2. 53. see city roots cmty. land tr. & yale envtl. prot. clinic, confronting racial covenants: how they segregated monroe county and what to do about them (2020) (listing states that have done this and cities that are mapping racial covenants). 368 indiana health law review [vol. 18:355 possibility would be for the covenants to be crossed out on the deeds, with notations that the covenants are illegal and unenforceable. a law professor reported that when he bought a house in los angeles, prior transactions that had been superseded were “carefully lined out in blue ink and initialed by a title company employee to highlight that they were no longer effective,” though the racial covenant in his deed “was untouched.”54 notice of the covenants’ illegality might be provided with the deeds that contain them. the full u.s. court of appeals for the district of columbia circuit held in 1972 that it was unlawful for the recorder of deeds to accept and file or provide copies of deeds with such covenants without providing a notice that the covenants are “null and void.”55 an opinion in that case reported that “the major title companies . . . responsible for 95% of the deeds presented for recordation . . . have agreed with the justice department not to report racially restrictive covenants in their title policies.”56 in another case, the u.s. department of justice secured from a federal trial court an order requiring a county clerk to “post in her office and affix to all documents pertaining to real property furnished by her office a notice stating that racially restrictive covenants are void under federal law.”57 yet another response is to use the covenants as educational or exorcistic tools. rothstein, for example, suggests adding to a deed with a racial covenant a provision that says the covenant is “unenforceable, unlawful, and morally repugnant”; and that the owners “repudiate this clause, are ashamed for our country that many once considered it acceptable, and state that we welcome with enthusiasm and without reservation neighbors of all races and ethnicities.”58 similarly, each house that is the subject of such a covenant might bear a plaque reporting the covenant’s creation, purpose, and repudiation.59 this would be similar to the stolpersteine – stumble stones – in germany, that mark the last homes in which victims of the nazis lived in freedom.60 michael gorra praises the stolpersteine as the best vehicle i know for the process of what in german is called vergangenheitsbewältigung, the process of working through or 54. e-mail from david glazier, professor of law, loyola law sch., to the ass’n of am. law schs.’ section on prop. law listserv (aug. 6, 2020) (on file with author). 55. mayers v. ridley, 465 f.2d 630 (d.c. cir. 1972) (en banc). but see the powerful dissent of judge fearing in the recent case of may v. spokane county, 481 p.3d 1098, 1104-14 (wash. ct. app. 2021) (arguing that any remedy but physical elimination of the covenant is inadequate). 56. mayers, 465 f.2d at 646 (referring to judge wright’s concurrence). 57. united states v. univ. oaks civic club, 653 f. supp. 1469, 1476 (s.d. texas 1987). 58. rothstein, supra note 8, at 221-22. 59. see generally florence wagman roisman, stumbling stones at levittown: what to do about racial covenants in the united states (dec. 10, 2020) (unpublished manuscript) (on file with the author). 60. see michael gorra, the saddest words: william faulkner’s civil war 324 (2020). 2021] structural racism in housing in indianapolis 369 overcoming through the past . . . a fusion of the noun for ‘pasts’ . . . with the word that denotes the idea of coping or mastering, and always with a sense of struggle. it is what one does, must do, with a difficult and recalcitrant history, a history for which one’s people bear responsibility: a struggle that may last for generations and that extends even to those individuals who carry no personal share of the burden.61 a combination of rothstein’s correction of the deeds and plaques on the houses seems to be potentially very effective. to enhance both, the extent of the covenants’ use should be documented. racial covenants have been analogized to monuments to slaveholders, confederate soldiers, and leaders of the ku klux klan.62 like those monuments, the covenants are offensive, hurtful reminders of racial hatred and degradation. what has been written of the slavery/confederacy/klan monuments is, i think true of the racial covenants – that they “poison[] our generations like radioactivity in the soil.”63 that radioactivity should be eliminated. 61. id. at 325. 62. this analogy is implicit in mason v. adams cty. recorder, 901 f.3d 753, 758 (6th cir. 2018). 63. ayana mathis, reviewing gorra, supra note 60, wrote that in his final chapters, gorra “compares america’s monuments to the confederacy with germany’s memorials to the holocaust. it would be unthinkable to most americans if such memorials celebrated the third reich, yet monuments to the confederacy and its legacy of slavery are ubiquitous . . . poisoning our generations like radioactivity in the soil.” ayana mathis, the trauma of the civil war lives on in faulkner’s fiction, n.y. times (aug. 25, 2020), https://www.nytimes.com/2020/08/25/books/ review/the-saddest-words-michael-gorra.html [https://perma.cc/he7x-5thx]. surviving gentrification and segregation courtney lauren anderson* i. introduction the connection between health and housing cannot be overstated. highlighting the health disparities caused by both illegal and legal housing laws and policies is an important part of understanding how environmental factors affect health, as well as advocating for the law to be used to mitigate health disparities rather than to worsen them. past housing laws and present housing policies and practices have segregated neighborhoods by race. these practices, together with segregation and racism, have resulted in adverse health outcomes for people of color. the recognition of housing policies in health is an important component to creating health equity. several policies initiated and supported by the government and private entities have resulted in extreme segregation in the united states. i will give brief overviews of redlining and restrictive covenants to illustrate their negative effects. after providing a historical overview of these laws, i will describe present housing laws and practices that result in segregation and, ultimately, health disparities. this includes the fair housing act, low-income housing tax credit, annexation and municipal incorporation, and gentrification. as the fair housing act was specifically enacted to combat segregation and housing discrimination, we will review the purpose of the act and how it has not been realized. i believe that the concept and fallout of disparate impact are integral to understanding the implications. today, most discrimination falls into this category, so we will talk about the current landscape of housing policies to reveal why – post-civil rights legislation – we continue to see segregated cities. furthermore, gentrification presents challenges to unpacking housing discrimination and maintaining and creating affordable housing. laws designed to expand or contract the borders of municipalities can present very few barriers to deciding to selectively annex or exclude certain neighborhoods. despite their legality, the aforementioned measures can disadvantage people of color by increasing segregation and displacement, worsening their health outcomes. finally, i will provide more detail about the danger of health disparities to underscore the importance of including housing laws in the broader public health agenda. ii. restrictive covenants and redlining restrictive covenants played a significant role in racial segregation. “a restrictive covenant is ‘a private agreement . . . that restricts the use or occupancy of real property’”1 the proliferation of these covenants was instituted by white communities in response to the migration of african americans from the south in the early 1900s. these covenants were designed to limit the transfer and sale * associate professor of law at georgia state university college of law. 1. grace fellowship church, inc. v. harned, 5 n.e.3d 1108, 1113 (11th cir. 2013). 284 indiana health law review [vol. 18:283 of property to people who were not white.2 the federal government in 1934 endorsed such segregation by refusing to underwrite mortgages for homes unless a racial covenant was in place. then, following activism from black americans, the united states supreme court unanimously ruled that these covenants were unenforceable in 1948. the legality of the inclusion of these prohibitions in recording instruments was not challenged until that year,3 and it was not until 1962 that the court ruled that racially restrictive covenants were unconstitutional.4 redlining is the practice in which a bank or financial institution denies or increases the cost of banking to consumers based on the racial makeup of their neighborhood.5 the home owners’ loan corporation was created to help prevent foreclosures and increase homeownership in response to the great depression.6 communities of color were explicitly harmed by the redlining practices of this entity.7 it created maps to determine where lending for residences would be permitted.8 on these maps, some neighborhoods were colored and labeled "hazardous" for lending because of the presence of african americans in the neighborhood and received a grade of “d.”9 neighborhoods that received the highest grade of a were colored green on the maps and considered “best.”10 as a result of redlining, black families were prohibited from receiving a loan to purchase homes in the neighborhoods where they lived.11 neighborhoods comprised of mostly white families were likely to be deemed “best” and colored green.12 the fair housing act of 1968 prohibits redlining,13 but the effects on homeownership are long-lasting.14 as a result of entrenching racial discrimination into the law, the typical homeowner in a redlined neighborhood gained 52% less in personal wealth generated by property value increases than one in a 2. richard brooks & carol rose, saving the neighborhood: racially restrictive covenants, law, and social norms 2-6 (2013). 3. id. at 3. 4. see shelly v. kraemer, 334 u.s. 1 (1948). 5. khristopher j. brooks, redlining’s legacy: maps are gone, but the problem hasn’t disappeared, cbs news (june 12, 2020), https://www.cbsnews.com/news/redlining-what-ishistory-mike-bloomberg-comments/ [https://perma.cc/hg34-bte8]. 6. bruce mitchell & juan franco, nat’l cmty. reinvestment coal., holc “redlining” maps: the persistent structure of segregation and economic inequality 6 (2018), https://ncrc.org/wp-content/uploads/dlm_uploads/2018/02/ncrc-research-holc-10.pdf [https://perma.cc/jpw2-w3tc]. 7. id. at 4. 8. id. 9. id. at 8. 10. id. 11. id. 12. id. 13. id. at 5. 14. id. at 2. 2021] surviving gentrification and segregation 285 neighborhood deemed “best” over the last forty years.15 the implications of these now illegal practices are still present today. furthermore, there are ongoing practices that perpetuate segregation. laws designed to create housing equity have failed to produce the integration and justice required to undo years of explicit discrimination. iii. the fair housing act and other housing laws section 801 of the fair housing act (the “fha” or the “act”) declares, “[i]t is the policy of the united states to provide, within constitutional limitations, for fair housing throughout the united states.”16 this act was the culmination of racial justice protests, resistance to discrimination and violence, and other aspects of the civil rights movement. the act also states that “[a]ll executive departments and agencies shall administer their programs and activities relating to housing and urban development . . . in a manner affirmatively to further the purposes of [the fha].”17 although this clause is ambitious and altruistic, it lacks the requisite enforcement mechanisms to bring about real change. also, it aligns with the overall intent of the fha, which is to construct social and economic integration in neighborhoods that were formerly divided by racial segregation. the ongoing concentration of poverty in racially isolated neighborhoods shows that this goal has not been achieved.18 the low rates of black homeownership, when compared to whites, further illustrates present housing injustices.19 low income housing tax credit (“lihtc”) is responsible for creating the majority of affordable housing in the united states. private developers compete for lihtc, which provides tax subsidies in exchange for these developers creating housing that is required to remain affordable for at least thirty years. however, the placement of lihtc units can also disproportionately and adversely affect people of color. this is because these units are more often than not erected in places that are primarily black and low-income. until a program that creates a majority of affordable housing in the united states can do so without inherent racial bias, the health of people who are adversely affected by this practice will continue to decline. lihtc is not the only well-meaning policy that has consequences that negatively impact communities of color. annexation is a policy designed to provide municipalities with the ability to define their own 15. dana anderson, redlining’s legacy of inequality: $212,000 less home equity, low homeownership rates for black families, redfin (june 11, 2020), https://www.redfin.com/news/ redlining-real-estate-racial-wealth-gap/ [https://perma.cc/m6h5-2kpj]. 16. 42 u.s.c. § 3601 (2020). 17. 42 u.s.c. § 3608 (2020). 18. see generally john iceland et al., u.s. census bureau, racial and ethnic residential segregation in the united states: 1980-2000, at 3-4 (2002), https://www.census. gov/prod/2002pubs/censr-3.pdf [https://perma.cc/bgn7-ht7p]. 19. u.s. census bureau, quarterly residential vacancies and homeownership, fourth quarter 2020, at 9 (2021), https://www.census.gov/housing/hvs/files/currenthvspress.pdf [https://perma.cc/8ajt-48se]. 286 indiana health law review [vol. 18:283 boundaries. however, the procedures required for this are not consistent among the states. this next section explains the variety of annexation statutes. iv. annexation this section demonstrates the extreme value of annexation for urban municipal corporations and helps explain the correlation observed in “defensive incorporation” by fringe communities. urban sprawl and the phenomenon of “white flight” fit perfectly with this constant struggle for urban municipal elasticity. so, how do different states approach the issue of annexation? russel m. smith identifies three primary approaches to annexation procedures and limitations: (1) “only allow annexations to occur through a state legislative approval process,” (2) “require the area being annexed to approve the annexation,” and (3) “allow municipalities to annex unilaterally.”20 the first of these seems to conform to a generally positive state model of land-use regulation. the second conforms to a civic republican model, and the third conforms to a libertarian model. but, do these models actually correlate in practice as legislative designs? this section focuses on answering this question with respect to four states: north carolina, georgia, california, and illinois; each, respectively, ranges from examples of more state involvement to less with regard to the powers allotted to municipal discretion as entities of their respective states. 1. north carolina: an example of more state involvement in city of greensboro v. guilford county board of elections, the united states district court for the middle district of north carolina notes that under the north carolina constitution “municipalities have no inherent powers; they have only such powers as are delegated to them by legislative enactment.”21 however, as the court articulates, the general assembly is not at liberty to exercise that power “in a manner prohibited by the north carolina constitution . . . subject to the equal protection clause of the united states constitution.”22 the court ruled that an act that withdrew the statutory right to petition for a referendum from the voters of greensboro but left alone the rights of voters in other municipalities of the state, had no rational basis for the distinction, and was unconstitutional.23 in north carolina, the process of municipal incorporation is statutorily tethered to legislative consent: “no area may incorporate without the approval of 20. russell m. smith, city limits?: the impact of annexation on the frequency of municipal incorporation in north carolina, 51 se. geographer 422, 427 (2011). 21. city of greensboro v. guilford county bd. of elections, 120 f. supp. 3d 479, 486 (m.d.n.c. 2015) (quoting in re ordinance of annexation no. 1977–4, 249 s.e.2d 698, 707 (n.c. 1978)). 22. id. 23. id. at 492. 2021] surviving gentrification and segregation 287 the north carolina general assembly.”24 the civic republican focus on local impact, as well as the bureaucratic “red-tape” of positive state influence on both sides of the issue, gives communities ample time and discretion to proactively and reactively incorporate or petition for annexation. 2. georgia, california, and illinois: examples of less state involvement other states like georgia, california, and illinois provide greater constitutional authority for municipalities outside of the limits of statutory legislation. while georgia’s constitution articulates the general assembly’s responsibility to govern municipal limitations, it also gives the general assembly “the authority to delegate its power so that matters pertaining to municipalities may be dealt with without the necessity of action by the general assembly.”25 local governance in california consists of an amalgamation of localist, regionalist, and civic republican models of regulation. “in april of 1954, the lakewood communities, under threat of annexation from the city of long beach, incorporated as the state’s 16th-largest city and the largest community in the united states ever to incorporate as a sovereign city.”26 the city then collaborated with the county government and private service providers to “deliver public administration in a cost effective manner.”27 as frank vram zerunyan points out, this model of contract cities “encourages the public and private sectors to jointly study experience and solve policy and public administration challenges.”28 this independence from state authority and oversight of the needs of local communities clearly conforms to a civic republican model of land-use regulation, while partially embracing both localist and regionalist perspectives on municipal governance. illinois has essentially given up all authority and granted sovereignty to a several counties and municipalities. further, municipal power of annexation is semi-unilateral, requiring only a petition meeting standard requirements without legislative approval and simple majority approval by those within the territory to be annexed.29 essentially, illinois has embraced a civic republican model of regulation over municipalities, combined with an annexation model that reflects a libertarian perspective. as shown herein, annexation and municipal incorporation laws vary from state to state. segregation is exacerbated when cities have the ability, with little oversight, to exclude or include certain neighborhoods from their borders. racebased movement between cities also occurs when involuntary displacement 24. smith, supra note 20, at 428. 25. ga. const. art. ix, § ii, para. ii. 26. frank vram zerunyan, the evolution of the municipal corporation and the innovations of local governance in california to preserve home rule and local control, 44 fordham urb. l.j. 217, 234 (2017) (footnote omitted). 27. id. (footnote omitted). 28. id. at 235. 29. see 65 ill. comp. stat. 5/7 (2020). 288 indiana health law review [vol. 18:283 results from gentrification. v. gentrification gentrification occurs when historically black neighborhoods become overwhelmingly white as a result of private and public practices that reduce the availability of affordable housing.30 often, these neighborhoods were plagued by divestment for years by the government and businesses.31 white flight further depleted the resources of these communities.32 when white people move back into these neighborhoods and businesses are incentivized to establish a presence there, property taxes increase.33 in addition to the increased cost of living, the social and cultural fabric of the neighborhoods shifts away from their historic roots to accommodate the preferences of wealthier, white residents.34 with racial segregation comes segregated school systems, better-resourced schools attended by those living in the wealthier neighborhoods, and property taxes to support these institutions.35 families with children who attend poorer-performing schools often live in neighborhoods that have experienced disinvestment and involuntary mobility. all of these factors negatively affect health outcomes. gentrification is another legal practice, yet it creates neighborhoods antithetical to the purpose of laws passed to create integration and prohibit discriminatory housing practices. there are several quality-of-life consequences to segregation, with health being no exception. vi. health and housing disparities social determinants play a significant role in our health.36 disparities in socioeconomic factors are twice as likely to predict health outcomes than health care.37 housing is an important factor in such determinations. living in substandard housing and the surrounding environment can have adverse health effects. segregation and a lack of affordable housing are also factors that contribute to poor health. the racial implications of all of these elements deepen racial health disparities and accounts in large part for people of color experiencing negative health outcomes at disproportionately high rates. communicable and chronic diseases thrive in poor housing environments, 30. courtney jones-hall, housing patterns, academic performance and school choice: an inquiry into the relocation experiences of african-american families, ga. s. electronic theses & dissertations 1, 40 (2013). 31. see, e.g., id. at 64. 32. id. at 60. 33. see, e.g., id. at 40. 34. see id. at 20. 35. see id. at 31. 36. dayna bowen matthew, health and housing: altruistic medicalization of america’s affordability crisis, 81 l. & contemp. probs. 161, 166 (2018). 37. id. 2021] surviving gentrification and segregation 289 with poor ventilation and sanitation exacerbating these ailments.38 these diseases include respiratory illnesses, neurological ailments, and a variety of other dysfunctions.39 in many cases, asthma is attributable to mold, allergens, heating systems that are not up to date, and pests that are more prevalent in substandard housing.40 conditions outside of the home also affect health,41 which is why understanding neighborhoods and the racial implications of laws and policies that create them must be analyzed to holistically understand health disparities. living near risk factors, such as landfills and highways, results in exposure to pollutants and adversely impacts health.42 lower-income neighborhoods often suffer from a lack of green space, which reduces the ability to safely participate in outdoor recreational activities.43 this reduced opportunity to be physically active can lead to obesity and other illnesses that can be prevented by engaging in a healthy lifestyle.44 these low-income neighborhoods also have fewer healthy food options and a large number of unhealthy food options. the lifestyles of people who live in these communities are significantly impacted by these environmental factors, which drive health outcomes.45 racial residential segregation accounts for health disparities between white and black populations.46 segregation can keep communities of color physically separated from quality-of-life assets, such as good schools, employment, and transportation, and can keep poverty, crime, and pollutants within the neighborhood’s borders.47 the mental health consequences of this separation and isolation include depression, anxiety, and stress.48 more than 200,000 people are experiencing homelessness and living completely unsheltered in the united states.49 this puts these individuals at very high rates of contracting an illness.50 people experiencing homelessness suffer from higher rates of pneumonia, hiv, other infectious diseases, chronic illness, and psychotic disorders than those who are not homeless.51 38. id. 39. id. 40. id. 41. id. at 167. 42. id. 43. id. 44. id. 45. id. 46. id. 47. id. at 167-68. 48. id. at 168. 49. andrew aurand et al., nat’l low income hous. coal., out of reach: the high cost of housing 1 (2020), https://reports.nlihc.org/sites/default/files/oor/oor_2020.pdf [https:// perma.cc/pf6z-xuvt]. 50. id. 51. see, e.g., comm. on health care for homeless people, inst. of med., homelessness, health, and human needs 1 (1988). 290 indiana health law review [vol. 18:283 homelessness is especially dangerous in a pandemic, given the difficulties of quarantining and observing sanitary measures without having a home.52 in addition to the hundreds of thousands of people who are forced to live on the streets, over 350,000 people are living in shelters for people without homes.53 there are also more than two million people who are living in overcrowded living situations.54 these groups of people, though sheltered, are also at higher risk of covid-19 exposure given that it is much harder to social distance in these situations.55 the death of affordable housing is partly to blame for this. there are thirtysix affordable rental homes available for every 100 extremely low-income renters who are seeking such housing.56 due to the lack of affordable housing, 86% of extremely low-income renters cannot afford their rent, and 71% (close to eight million) of extremely low-income renters spend more than half of their incomes on housing costs.57 since federal housing funding reaches a mere 25% of eligible renters,58 many people have no choice but to spend greater percentages of their income on housing. housing is affordable when no more than 30% of household income is spent on the cost of living expenses.59 when spending on housing exceeds this threshold, families are required to sacrifice money that would be spent on necessities, such as food and medical care.60 people living in costburdened situations experience lower health outcomes because of these tradeoffs.61 further, housing instability results from frequent moves, which is a necessary action as people seek affordable housing or are otherwise displaced. in particular, these frequent moves adversely impact the health of children.62 people of color are more likely to live in unaffordable housing,63 experience 52. aurand et al., supra note 49. 53. id. 54. id. 55. see id. 56. id. 57. id. 58. will fischer & barbara sard, chart book: federal housing spending is poorly matched to need, ctr. budget & pol’y priorities (mar. 8, 2017), https://www.cbpp.org/research/housing/ chart-book-federal-housing-spending-is-poorly-matched-to-need [https://perma.cc/q87b-f9qq]. 59. defining housing affordability, u.s. dep’t housing & urb. dev., https://www.huduser. gov/portal/pdredge/pdr-edge-featd-article-081417.html [https://perma.cc/cr39-tw36] (last visited mar. 13, 2021). 60. id. 61. id. 62. kathryn bailey et al., overcrowding and frequent moves undermine children’s health, child. healthwatch (nov. 2011), https://childrenshealthwatch.org/wp-content/uploads/ crowdingmultiplemoves_brief_november2011.pdf [https://perma.cc/h38b-fw7c]. 63. racial disparities among extremely low-income renters, nat’l low income housing coalition (apr. 15, 2019), https://nlihc.org/resource/racial-disparities-among-extremely-lowincome-renters [https://perma.cc/r7vr-mj6k]. 2021] surviving gentrification and segregation 291 homelessness,64 live in poverty, and make disproportionately lower wages.65 this compounds the negative health outcomes these communities face due to laws and policies that create and maintain racial segregation. vii. conclusion health disparities are preventable differences in the burden of disease and opportunities to achieve optimal health experienced by socially disadvantaged populations.66 it is important to recognize that there are socioeconomic determinants of health that cause people of color to experience adverse health outcomes at much higher rates than white people because the implicit and explicit racial bias in housing laws and policies do not just perpetuate segregation but deepen these inequities and worsen instances of chronic disease and mental health ailments for communities of color. 64. racial disparities in homelessness in the united states, nat’l alliance to end homelessness (june 6, 2018), https://endhomelessness.org/resource/racial-disparitieshomelessness-united-states/ [https://perma.cc/9t3l-ed3g]. 65. valerie wilson, racial disparities in income and poverty remain largely unchanged amid strong income growth in 2019, econ. pol’y inst. (sept. 16, 2020), https://www.epi.org/ blog/racial-disparities-in-income-and-poverty-remain-largely-unchanged-amid-strong-incomegrowth-in-2019/ [https://perma.cc/qv7u-efy8]. 66. adolescent and school health, ctr. for disease control & prevention (nov. 24, 2020), https://www.cdc.gov/healthyyouth/disparities/index.htm [https://perma.cc/et8g-y96r]. patient one: an exploration of criminal justice and mental health robert r. rigg* abstract this article probes issues that arise when an individual suffering from a serious mental health disorder is prosecuted in the criminal justice system. the analysis turns to the pivotal question of patient one: what becomes of a person suffering from a serious mental health disorder after the criminal justice system is finished with them? within that framework, there is a discussion of privacy issues, guardianships, and the evaluation and treatment of those who suffer from a serious mental illness, as well as competing interests of those who are charged with the care of those patients. the purpose of this article is to examine one representative case in which the criminal justice system intersects with an individual with a serious mental illness and stimulate discussion for reform. i. introduction in 2017 one-third of the prison population in iowa was suffering from a serious mental illness.1 the definition of serious mental illness (smi) employed by the iowa department of corrections (idoc) is “chronic and persistent mental illnesses in the following categories: schizophrenia[;] recurrent major depressive disorders[;] bipolar disorders[;] other chronic and recurrent psychosis[;] and dementia and other organic disorders.”2 in the 2016 report, the idoc also included a category of inmates suffering from “other chronic mental illness” which totaled twenty-four percent of the prison population.3 the total number of inmates suffering from a serious or chronic mental health disorder * director, criminal defense program, drake university law school; professor of law, drake university law school; j.d., drake university law school, 1977; b.a., drake university, 1975. i would like to thank my research assistants tess pocock, olivia brooks, and kyle crawford for their assistance in preparing this article. i am particularly indebted to tess pocock with her help in editing the proposal to the drake institutional review board as well as the final draft of the article. i would also like to express my appreciation to institutional review board for their approval of this project and to patient one’s guardian, without whom this article would not be possible. dedicated to sam, glenn, louise and holly. 1. iowa dep’t of corr. fy2016 ann. rep., st. of iowa dep’t of corrections, 2016, at 10, 17, https://doc.iowa.gov/sites/default/files/documents/2017/01/fy16_doc_annual_report_1.pdf [https://perma.cc/yra6-eamc] (documenting 2,724 out of 8,207 total inmates or 33.2%). 2. mental health info. sharing program, iowa dep’t of corr. 2 (jan. 2017), http://idph.iowa.gov/portals/1/meetings/meetingfiles/otherfiles/95/8d8a73aa-da57-475e-b44f77c91800cbd0.pdf [https://perma.cc/2muq-wufu]. 3. iowa dep’t of corr. fy2016 ann. rep., st. of iowa dep’t of corrections, 2016, at 10, 17, https://doc.iowa.gov/sites/default/files/documents/2017/01/fy16_doc_annual_report_1.pdf [https://perma.cc/yra6-eamc] (documenting 1,974 out of 8,207 total inmates or 24.1%). http://doi.org/10.18060/3911.0055 68 indiana health law review [vol. 16:67 constituted fifty-seven percent of the prison population.4 iowa is not alone.5 other jurisdictions have significant numbers of prison populations suffering from mental health disorders.6 inmates in local jails are not included in these percentages. according to the united states department of justice (doj), jail inmates with mental health problems constitute sixty-four percent of the prison population nationally.7 the consequences of these proportions has led to litigation, and ultimately a decision by the united states supreme court.8 the purpose of this article is to examine one representative case in which the criminal justice system intersects with an individual with a serious mental illness. through that lens, the article will identify problems within the system and suggest changes. patient one is one of the 479,900 inmates who was being held in a local jail.9 patient one falls in a group of individuals who have serious mental illness, which renders him incompetent to stand trial.10 patient one’s illness is serious, chronic, and profound—to such an extent as to place him in the category of those who will 4. mental health info. sharing program, supra note 2 (documenting 2,724 (smi) + 1,974 (cmi) = 4,698 out of 8,207 inmates or 57.2%). 5. see doris j. james & lauren e. glaze, mental health problems of prison and jail inmates, u.s. dep’t of just. bureau of just. stat. special rep. 2-3 (dec. 14, 2006), https://www.bjs.gov/content/pub/pdf/mhppji.pdf [https://perma.cc/l3bc-5wjf]. “at midyear 2005 more than half of all prison and jail inmates had a mental health problem, including 705,600 inmates in state prisons, 78,800 in federal prisons, and 479,900 in local jails. these estimates represented 56% of state prisoners, 45% of federal prisoners, and 64% of jail inmates. the findings in this report were based on data from personal interviews with state and federal prisoners in 2004 and local jail inmates in 2002.” id. at 1. 6. id. at 11. 7. id. at 1. 8. see brown v. plata, 563 u.s. 493 (2011). “prisoners in california with serious mental illness do not receive minimal, adequate care. because of a shortage of treatment beds, suicidal inmates may be held for prolonged periods in telephone-booth sized cages without toilets. a psychiatric expert reported observing an inmate who had been held in such a cage for nearly 24 hours, standing in a pool of his own urine, unresponsive and nearly catatonic. prison officials explained they had “‘no place to put him.’” other inmates awaiting care may be held for months in administrative segregation, where they endure harsh and isolated conditions and receive only limited mental health services. wait times for mental health care range as high as 12 months. in 2006, the suicide rate in california’s prisons was nearly 80% higher than the national average for prison populations; and a court-appointed special master found that 72.1% of suicides involved “some measure of inadequate assessment, treatment, or intervention, and were therefore most probably foreseeable and/or preventable.” id. at 503-04 (internal citations omitted). 9. “patient one” was selected rather than characterizing the individual as the “defendant” to focus on the medical issues faced by individuals in the criminal justice system. james & glaze, supra note 5. 10. id. at 3. 2018] patient one: an exploration of criminal justice and mental health 69 never be competent to stand trial with current therapies and medications.11 in a typical case, an individual is discharged from the criminal justice system, and returns to the streets.12 the individual’s case is typically dismissed, without any aftercare strategy in the mental health system, even though they are incompetent.13 recidivism in these cases is almost guaranteed.14 patient one’s case history is typical of the category of those who have serious mental health issues, and who have the misfortune of becoming part of the criminal justice system. however, patient one’s story is different. his criminal case was ultimately dismissed. but patient one was not unceremoniously dropped onto the streets. there was one important difference in his case: a family member serves as his guardian.15 although the worst-case scenario was avoided, there are still 11. see drope v. missouri, 420 u.s. 162 (1975). “it has long been accepted that a person whose mental condition is such that he lacks the capacity to understand the nature and object of the proceedings against him, to consult with counsel, and to assist in preparing his defense may not be subjected to a trial.” id. at 171. 12. iowa code § 812.9 (2018) (“[t]he defendant shall not remain under placement pursuant to section 812.6 beyond the expiration of the maximum term of confinement for the criminal offense of which the defendant is accused, or eighteen months from the date of the original adjudication of incompetence to stand trial, including time in jail, or the time when the court finds by a preponderance of the evidence that there is no substantial probability that the defendant will be restored to competency in a reasonable amount of time under section 812.8, subsection 8, whichever occurs first. when the defendant’s placement in an inpatient facility equals the length of the maximum term of confinement, the complaint for the criminal offense of which the defendant is accused shall be dismissed with prejudice.”). 13. iowa code § 812.3(1) (2018). (“if at any stage of a criminal proceeding the defendant or the defendant’s attorney, upon application to the court, alleges specific facts showing that the defendant is suffering from a mental disorder which prevents the defendant from appreciating the charge, understanding the proceedings, or assisting effectively in the defense, the court shall suspend further proceedings and determine if probable cause exists to sustain the allegations.”); see also iowa code § 633.3(23) (defining incompetent as “the condition of any person who has been adjudicated by a court to meet at least one of the following conditions: a. to have a decisionmaking capacity which is so impaired that the person is unable to care for the person’s personal safety or to attend to or provide for necessities for the person such as food, shelter, clothing, or medical care, without which physical injury or illness may occur. b. to have a decision-making capacity which is so impaired that the person is unable to make, communicate, or carry out important decisions concerning the person’s financial affairs. c. to have a decision-making capacity which is so impaired that both paragraphs “a” and “b” are applicable to the person.”). 14. the iowa department of corrections estimates that individuals with a chronic mental illness diagnosis are at a 40.7 percent risk of returning to prison within three years as opposed to 26 percent of those without mental illness. iowa dep’t of corr., supra note 3. 15. iowa code § 633.3(20) (2018) (noting the court can also appoint a guardian “meaning the person appointed to the custody of the person of the ward under the provisions of the probate code.”). 70 indiana health law review [vol. 16:67 significant deficiencies within the criminal justice system that demand attention. most importantly, early recognition of the mental health issues.16 ii. the arrest a. “get the fuck out of here!” patient one was arrested for assaulting a peace officer at approximately 10:00 pm on january 2, 2015, while at a group home.17 in an affidavit attached to the preliminary complaint, an officer described the encounter: [patient one] assaulted me while i was on duty. i was called to the facility on [patient one] causing a problem with the nursing staff. when i arrived [patient one] started the encounter with, “get the fuck out of here.” i advised [patient one] who i was and why i was called down to the residential facility. he again stated for me to leave. i told [patient one] i could not do that. he began raising his voice and yelling at me. [patient one] took a stance as if he was going to come at me, i pulled my tazer and ordered [patient one] to turn around with his hands behind his back. [patient one] did not comply. i ordered him again. he took at [sic] step toward me, i grabbed [patient one’s] wrist with my left hand and had tazer in right hang. [patient one] swung at me i stepped back and then moved forward and we both went to the ground. i was on top of [patient one] trying to gain control. i took the cartridge out of the tazer and delivered several dry stuns to [patient one’s] shoulder blade, trap muscle area. the tazer took no affect on [patient one]. [patient one] had ahold of my left wrist and was trying to pull it underneath him. after about a minute or two i told the nurse to call 911 and tell them i need assistance. at this time i jumped away from [patient one] and retrieved the tazer cartridge and placed it back into the tazer. [patient one] came back to his feet. i radioed to dispatch that i need emergent [sic] assistance. i ordered [patient one] to turn around and put his hands behind his back, again [patient one] did not comply. he started walking toward me, i deployed the tazer, striking [patient one] in the chest and abdominal area. the tazer had very little affect on [patient one]. he turned away from me, while the tazer was still on its cycle, i struck [patient one] with my foot to the back of his patella, causing him to 16. “while hipaa provides important protection of medical privacy, some family members of persons with mental illness argues that hipaa prevents them from being able to adequately care for their loved ones.” naomi weinstein & michael l. perlin, “who’s pretending to care for him?” how the endless jail-to-hospital-to-street-repeat cycle deprives persons with mental disabilities the right to continuity of care, 8 wake forest j. l. & pol’y 455, 478 (2018) (citing jorgio castro, piercing the privacy veil: toward a saner balancing of privacy and health in cases of severe mental illness, 66 hastings l.j. 1769, 1772 (2015)). 17. preliminary complaint at 1-2 (jan. 3, 2015), source available from author or ihlr upon request. 2018] patient one: an exploration of criminal justice and mental health 71 fall.18 subsequent police reports elaborate on the initial report: [patient one] began to fall, and as he did he spun himself around, landing on his back. [patient one] struck the back of his head with the ground. [patient one] laid there in a daze. i went to [patient one] to render aid. i asked [patient one] what the problem was today, he was unable to answer me. i asked him if he was done fighting me he stated that he was. i assisted [patient one] up and to his knees where i placed hand cuffs on him. he was assisted to his feet. i radioed that i need medics for the tazer deploy as well as an injury to his head. i assisted [patient one] to the dining room and had him sit on a dining room chair. at this time officer [brown]19 was arriving. i asked officer [brown] to watch [patient one] while i got my tazer cartridge and get a voluntary statement for the nurse who witnessed the whole confrontation. medics arrived on scene along with several other officer, [sic] including sgt. [anderson].20 i advised sgt. [anderson] what took place. it was decided to have the pleasant hill fire department transport [patient one] to [a local hospital] to get his injury checked out. officer [brown] followed the ambulance to the hospital. i took the booking sheet to officer [brown] and [patient one] was transported to the polk county jail with no further incidences.21 iii. missed opportunities a. dispatch did dispatch adequately advise the officer of what they were walking into? situational awareness plays a crucial role. when the officer arrived, he knew or should have known—from the dispatch and from direct observation—that he was dealing with an agitated individual who was in a care facility.22 the complaint came from a nurse on duty.23 should the officer have inquired as to the nature of the complaint or required more specificity as to why the nurse “locked herself in the nurse[s] station for her safety”?24 should the officer have called for back-up prior to arriving on the scene? did the officer have training in responding to situations involving mentally impaired individuals? in patient one’s situation, if the dispatch alerted the officer that the call was 18. minutes of testimony incident report at 4 (jan. 30, 2018), source available from author or ihlr upon request. 19. in order to protect anonymity, a pseudonym is used. 20. in order to protect anonymity, a pseudonym is used. 21. minutes of testimony incident report supra note 18. 22. id. 23. id. 24. id. 72 indiana health law review [vol. 16:67 from a nurse in a living facility, and if the officer recognized the mental health issues, perhaps the officer may have avoided tasing patient one. importantly, the officer used force first in this situation when he drew his taser. when i arrived [patient one] started the encounter with, “get the fuck out of here.” i advised [patient one] of who i was and why i was called down to the residential facility. [patient one] again stated for me to leave. i told [patient one] i could not do that. [patient one] began raising his voice and yelling at me. [patient one] took a stance as if he was going to come at me, i pulled my tazer. . . 25 prior to that, patient one was agitated and yelling, and arguably no crime had been committed at this point. could the officer have lowered his voice and dealt with the patient in a quasi-hospital setting? assuming the responding officer could have deescalated the situation, his actions could have prevented an arrest. the next opportunity for patient one to be diverted from the criminal justice system was his transport to a local hospital for the treatment of his physical injuries. medics arrived on scene along with several other officer, [sic] including sgt. [anderson]. i advised sgt. [anderson] what took place. it was decided to have the [] fire department transport [patient one] to [the local hospital] to get his injury checked out. officer [brown] followed the ambulance to the hospital.26 notably, patient one had previously been treated at the local hospital on a number of occasions prior to transport for treatment of injuries. in a latter report by a treating physician it notes: [patient one] has an extensive history of schizophrenia, and has been hospitalized numerous times in the past, including in mount pleasant, cedar rapids, independence, and three times in the past two years at [the local hospital]. [patient one] is frequently non-compliant with oral medications. at his baseline, the patient is psychotic with chronic auditory hallucinations and delusions.27 by the hospital’s failure to recognize patient one’s history, an opportunity to divert patient one out of the criminal justice system was missed. at this point in time, patient one could have been civilly committed,28 avoiding the onus of criminal prosecution. 25. minutes of testimony incident report, supra note 18. 26. minutes of testimony incident report, supra note 18. 27. letter to the court (may 5, 2015) (emphasis added), source available from author or ihlr upon request. 28. iowa code § 229.6 (2018). 2018] patient one: an exploration of criminal justice and mental health 73 b. officer reporting although much has been advocated regarding training of police officers to identify mental health concerns when responding to an incident, as a practical matter, little has changed in officer reporting.29 regarding the initial contact with and interaction between patient one and the responding police officers, there is no clear portion of the reporting system dedicated to the defendant’s mental health status or condition.30 there are three important opportunities to improve this through officer reporting. first, the case investigation report form should be altered to include a category regarding the mental health of the individual being investigated or arrested.31 the initial investigation report is filed by law enforcement. it provides a gateway of information used through the life of a criminal case. this information is used in charging decisions, reviewing those decisions, bond conditions, plea negotiations, and sentencing, or as basis for dismissal of charges. an early recognition of mental health concerns would assist decision-makers in routing the case in a direction that would take into account the mental health of the individual. it would also alert the jail or detention center of possible medical concerns regarding the person after arrest and during booking. second, the initial charging document or preliminary complaint forms should be altered.32 there are several categories of information contained in the preliminary complaint, including information regarding: the offender; the offense; status of the offender; a brief narrative of victim information; and an affidavit including a general statement of probable cause.33 the document is prepared by the prosecutor’s office and is based on the initial case investigation report filed 29. see abigail s. tucker et al., responding to persons with mental illness (oct. 1, 2011), https://leb.fbi.gov/articles/featured-articles/responding-to-persons-with-mental-illness [https://perma.cc/y2et-safc]; h. richard lamb, linda e. weinberger, & walter j. decuir, jr., the police and mental health, 53 psychiatric services 1226 (oct. 1, 2002) (pointing out that police have inadequate training in handling encounters with this segment of the community); gary cordner, people with mental illness, ctr. for problem-oriented policing (2006), http://www.popcenter.org/problems/mental_illness [https://perma.cc/9cum-rj53]; linda a. teplin, keeping the peace: police discretion and mentally ill persons, nat’l inst. just. j. 9 (july 2000), https://www.ncjrs.gov/pdffiles1/jr000244c.pdf [https://perma.cc/7abs-9rdu]; megan pauly, how police officers are (or aren’t) trained in mental health, atlantic (oct. 11, 2013), https://www.theatlantic.com/health/archive/2013/10/how-police-officers-are-or-aren-t-trained-inmental-health/280485/ [https://perma.cc/r5et-dw6w]. 30. minutes of testimony, supra note 18, at 2-4. 31. the iowa incident report form contains a number of categories of information regarding incidents officers are called to investigate. the form includes information regarding the investigation, the victim, and the suspect, but no area for comments regarding mental health of the suspect. 32. iowa r. crim. p. 2.2(1)-(2). 33. preliminary complaint, supra note 17. 74 indiana health law review [vol. 16:67 by law enforcement. by incorporating mental health information in this first pleading, courts could make initial competency inquiries that would result in a medical evaluation and subsequent treatment.34 finally, booking information recorded as an individual enters their term of incarceration should include mental health concerns by arresting officers or the booking agency. this would ensure that others are put on notice of the mental health concerns in order to prevent future escalations. iv. the initial appearance a. who is john e. baron? after his arrest, on january 3, 2015, patient one appeared before a judicial officer for his initial appearance.35 during this appearance, he was asked to waive his preliminary hearing36 as well as fill out an application for court-appointed counsel.37 in both documents, patient one identified himself by signing “john e. baron,” a false name. this was documented in the court records and forms.38 in the application for court-appointed counsel, patient one went further, by indicating his date of birth as “alive and well.”39 in response to the form inquiring into his employment, he wrote “for sue ling and myself john e. baron.”40 in the space for property owned, he wrote “bull shit,”41 and dated the document “spring.”42 the rest of the application was left blank.43 after an individual is arrested, they are required to appear before a judicial officer for their initial appearance.44 with the defendant physically present, the court has an opportunity to observe the defendant. if the court is alerted by the preliminary complaint and through observing the individual in court that the individual may have mental health issues, the court ought to then make an initial inquiry. this could be accomplished by amending the iowa rules of criminal 34. law enforcement and prosecutors may be resistant to the inclusion of observations regarding an individual’s mental health status for fear of establishing a possible defense to the crime. 35. id. 36. waiver of preliminary hearing (jan. 3, 2015), source available from author or ihlr upon request. 37. financial affidavit and application for appointment of counsel, source available from author or ihlr upon request. 38. id.; waiver of preliminary hearing, supra note 36, at 2. 39. financial affidavit and application for appointment of counsel, supra note 37. 40. id. 41. id. 42. id. 43. id. 44. iowa r. crim. p. 2.2(1)-(2). 2018] patient one: an exploration of criminal justice and mental health 75 procedure45 and the competency statute.46 under the current rules of criminal procedure, there is no requirement for the court to inquire as to the mental health status of individuals at the initial appearance. as for the competency statute, the responsibility is on either the defendant or the defendant’s attorney to raise the issue of competency.47 the responsibility shifts to the court only if “the defendant or the defendant’s attorney has failed or refused to make an application.”48 these procedures delay early diagnosis and treatment of individuals with mental health concerns. by amending the statute to allow the court to raise the issue initially, the process would be abbreviated, thus allowing an individual with mental health issues to receive an earlier diagnosis and treatment. as it stands now, the court must wait for counsel to meet with the client and for the application for a competency examination. even more problematic, if the court declines to appoint counsel because the individual indicates they are going to retain counsel, or if they are going to represent themselves, the delay in treating mental health issues can be considerable and unnecessary. in patient one’s case, the court accepted the patient’s waiver of the preliminary hearing, set bond at $1000 dollars cash or surety, set an arraignment date for february 20, 2015, and accepted the patient’s declination of counsel.49 of course, allowing self-representation presents another set of issues. in patient one’s case, that is exactly what happened: a demand for self-representation. b. self-representation in farretta v. california, the united states supreme court held a defendant in a criminal case has a constitutional right to self-representation.50 however, that 45. id. 46. iowa code § 812.3(1) (2018). “if at any stage of a criminal proceeding the defendant or the defendant’s attorney, upon application to the court, alleges specific facts showing that the defendant is suffering from a mental disorder which prevents the defendant from appreciating the charge, understanding the proceedings, or assisting effectively in the defense, the court shall suspend further proceedings and determine if probable cause exists to sustain the allegations. the applicant has the burden of establishing probable cause. the court may on its own motion schedule a hearing to determine probable cause if the defendant or defendant’s attorney has failed or refused to make an application under this section and the court finds that there are specific facts showing that a hearing should be held on that question.” id. 47. id. (stating “the defendant or the defendant’s attorney” files an application). 48. id. (noting “the court may on its own motion schedule a hearing to determine probable cause if the defendant or defendant’s attorney has failed or refused to make an application…”). 49. order of initial appearance (jan. 3, 2015), source available from author or ihlr upon request. 50. faretta v. california, 422 u.s. 806 (1975). “in the federal courts, the right of selfrepresentation has been protected by statute since the beginnings of our nation. section 35 of the judiciary act of 1789, 1 stat. 73, 92, enacted by the first congress and signed by president washington one day before the sixth amendment was proposed, provided that ‘in all the courts of 76 indiana health law review [vol. 16:67 right is not absolute. in indiana v. edwards, the supreme court held counsel may be appointed where the defendant is competent to stand trial, but may not be able to represent themselves.51 the court asked “whether the constitution permits a state to limit that defendant’s self-representation right by insisting upon representation by counsel at trial—on the ground that the defendant lacks the mental capacity to conduct his trial defense unless represented.”52 in answering the question, the court reasoned: the nature of the problem before us cautions against the use of a single mental competency standard for deciding both (1) whether a defendant who is represented by counsel can proceed to trial and (2) whether a defendant who goes to trial must be permitted to represent himself. mental illness itself is not a unitary concept. it varies in degree. it can vary over time. it interferes with an individual’s functioning at different times in different ways.53 as other legal scholars have noted, there are no set standards for a trial court to determine competency for self-representation.54 the tension between the right the united states, the parties may plead and manage their own causes personally or by the assistance of such counsel . . . .’ the right is currently codified in 28 u.s.c. s 1654. with few exceptions, each of the several states also accords a defendant the right to represent himself in any criminal case. the constitutions of 36 states explicitly confer that right. moreover, many state courts have expressed the view that the right is also supported by the constitution of the united states. this court has more than once indicated the same view. in adams v. united states ex rel. mccann, . . . the court recognized that the sixth amendment right to the assistance of counsel implicitly embodies a ‘correlative right to dispense with a lawyer’s help.’ the defendant in that case, indicted for federal mail fraud violations, insisted on conducting his own defense without benefit of counsel. he also requested a bench trial and signed a waiver of his right to trial by jury. the prosecution consented to the waiver of a jury, and the waiver was accepted by the court. the defendant was convicted, but the court of appeals reversed the conviction on the ground that a person accused of a felony could not competently waive his right to trial by jury except upon the advice of a lawyer. this court reversed and reinstated the conviction, holding that ‘an accused, in the exercise of a free and intelligent choice, and with the considered approval of the court, may waive trial by jury, and so likewise may he competently and intelligently waive his constitutional right to assistance of counsel.’ . . . the adams case does not, of course, necessarily resolve the issue before us. it held only that ‘the constitution does not force a lawyer upon a defendant.’ . . . whether the constitution forbids a state from forcing a lawyer upon a defendant is a different question. but the court in adams did recognize, albeit in dictum, an affirmative right of selfrepresentation.” id. at 814-15. 51. indiana v. edwards, 554 u.s. 164 (2008). 52. id. at 174. 53. id. at 175. 54. e. lea johnston, communication and competence for self-representation, 84 fordham l. rev. 2121 (2016); e. lea johnston, representational competence: defining the limits of the right to self-representation at trial, 86 notre dame l. rev. 523 (2011); jason r. marks, state competence standards for self-representation in a criminal trial: opportunity and danger for 2018] patient one: an exploration of criminal justice and mental health 77 to self-representation in farretta and the limitation imposed by edwards have yet to be reconciled by either the psychiatric or legal communities. the competency standards currently utilized to evaluate the competency to stand trial,55 competency to plead guilty,56 and competency to self-represent,57 are standards developed by the legal community with little input from the psychiatric community. the supreme court attempted to differentiate competency to stand trial,58 competency to plead guilty,59 and competency for self-representation.60 state courts after indiana v. edwards, 44 u.s.f. l. rev. 825 (2010); christopher slobogin, mental illness and self-representation, 7 ohio st. j. crim. l. 391 (2009). 55. see faretta, 422 u.s. 806. 56. see moran, 509 u.s. 389. 57. see edwards, 554 u.s. 164. 58. id. at 169-70. the two cases that set forth the constitution’s “mental competence” standard, dusky v. united states, 362 u.s. 402 (1960), and drope v. missouri, 420 u.s. 162 (1975), specify that the constitution does not permit trial of an individual who lacks “mental competency.” dusky defines the competency standard as including both (1) “whether” the defendant has “a rational as well as factual understanding of the proceedings against him” and (2) whether the defendant “has sufficient present ability to consult with his lawyer with a reasonable degree of rational understanding.” dusky, 362 u.s. at 402 (emphasis added) (internal quotation marks omitted). drope repeats that standard, stating that it “has long been accepted that a person whose mental condition is such that he lacks the capacity to understand the nature and object of the proceedings against him, to consult with counsel, and to assist in preparing his defense may not be subjected to a trial.” drope, 420 u.s. at 171. (emphasis added). 59. edwards, 554 u.s. at 175. the court noted the competency required to plead guilty stating: “this court, reversing the court of appeals, ‘reject[ed] the notion that competence to plead guilty or to waive the right to counsel must be measured by a standard that is higher than (or even different from) the dusky standard.’ . . . the decision to plead guilty, we said, ‘is no more complicated than the sum total of decisions that a [represented] defendant may be called upon to make during the course of a trial.’ . . . hence ‘there is no reason to believe that the decision to waive counsel requires an appreciably higher level of mental functioning than the decision to waive other constitutional rights.’ . . . and even assuming that self-representation might pose special trialrelated difficulties, ‘the competence that is required of a defendant seeking to waive his right to counsel is the competence to waive the right, not the competence to represent himself.’ for this reason, we concluded, ‘the defendant’s “technical legal knowledge” is “not relevant” to the determination.’” id. at 172 (quoting faretta, 422 u.s. at 836). see also moran, 509 u.s. 389 (1993). 60. edwards, 554 u.s. 164 (citing faretta, 422 u.s. 806). the court stated the underlying rationale for self-representation, “the court’s foundational ‘self-representation’ case, faretta, held that the sixth and fourteenth amendments include a ‘constitutional right to proceed without counsel when’ a criminal defendant ‘voluntarily and intelligently elects to do so.’ . . . the court implied that right from: (1) a ‘nearly universal conviction,’ made manifest in state law, that ‘forcing a lawyer upon an unwilling defendant is contrary to his basic right to defend himself if he truly wants to do so,’; . . . (2) sixth amendment language granting rights to the ‘accused’; (3) sixth amendment structure indicating that the rights it sets forth, related to the ‘fair administration of 78 indiana health law review [vol. 16:67 the court—in an effort to answer a medical question with a legal solution—cited to the amicus brief by the american psychiatric association (“apa”): the american psychiatric association (apa) tells us (without dispute) in its amicus brief filed in support of neither party that “[d]isorganized thinking, deficits in sustaining attention and concentration, impaired expressive abilities, anxiety, and other common symptoms of severe mental illnesses can impair the defendant’s ability to play the significantly expanded role required for self-representation even if he can play the lesser role of represented defendant.” . . . motions and other documents that the defendant prepared in this case (one of which we include in the appendix, infra) suggest to a layperson the common sense of this general conclusion.61 the apa’s amici brief further states: serious mental illnesses present a genuine threat to the vital public interest in reliable adjudication of contested criminal charges. such illnesses are often associated with delusional misperceptions of reality, inability to think coherently, and hallucinations… the defendant may not be able to recount relevant facts (e.g., where was edwards aiming when he fired his gun?), may misunderstand courtroom developments, may fail to maintain focus during trial proceedings, and may respond irrationally. cognitive deficiencies are commonly linked with impaired ability to formulate and to express thoughts in an understandable, coherent manner… severe anxiety, which is often present in psychotic disorders . . . can impair attentiveness and the ability to function in tense settings. depression can make decision-making difficult or so diminish motivation as to produce self-destructive decisions… long tradition specifically recognizes these risks and the importance of addressing them, for the protection of the defendant himself and of the public interest in reliable adjudication. the law governing competence to stand trial rests centrally, if not exclusively, on this basis.62 as previously noted, the pre-trial process governed by the iowa rules of american justice,’ are ‘persona[l]’ to the accused . . . ; (4) the absence of historical examples of forced representation; and (5) ‘”respect for the individual,”’. . . . faretta does not answer the question before us both because it did not consider the problem of mental competency (cf. 422 u.s., at 835, 95 s.ct. 2525 (faretta was ‘literate, competent, and understanding’)), and because faretta itself and later cases have made clear that the right of self-representation is not absolute.” id. at 170-71. 61. edwards, 554 u.s. 164 at 176 (quoting brief for the american psychiatric association and american academy of psychiatry and the law as amici curiae in support of neither party, indiana v. edwards, 554 u.s. 164 (2008), 2008 u.s. s. ct. briefs lexis 176, *17 (2008)). 62. brief for american psychiatric association and american academy of psychiatry and law as amici curiae supporting neither party, indiana v. edwards, 554 u.s. 164 (2008), 2008 u.s. s. ct. briefs lexis 176, *17 (2008). 2018] patient one: an exploration of criminal justice and mental health 79 criminal procedure would put patient one at a horrible disadvantage should the court allow self-representation. first, patient one would be required to identify his own mental health issues and the possible defenses that could be raised as a result, including: insanity63 and diminished responsibility.64 he would be required to file pre-trial motions for expert witnesses;65 file a notice of defense;66 and conduct discovery depositions of the state’s witnesses.67 needless to say, it is absurd for a court to allow patient one—who suffers from schizophrenia and is delusional—to proceed on a pre-trial basis, much less self-represent at trial.68 63. iowa code § 701.4 (2017). iowa adopted the 1843 m’naghten standard defining insanity. see robert r. rigg, vol. 4, iowa practice series, criminal law §§ 2.5-2.13 (20182019 ed.) 64. see rigg, supra note 63, at §§ 2.14-2.20. 65. see ake v. oklahoma, 470 u.s. 68 (1985); see also iowa r. crim. p. 2.20(4). 66. iowa r. crim. p. 2.11(11)(4). 67. iowa r. crim. p. 2.13. rule 2.13 provides that iowa allows pre-trial depositions of the state’s witnesses. 68. see e. lea johnston, communication and competence for self-representation, 84 fordham l. rev. 2121 (2016). professor johnston makes a case for a model standard for selfrepresentation: “a communication deficiency should support a finding of representational incompetence only to the extent that the deficiency either reveals an absence of meaningful autonomy or poses a grave threat to the reliability or the actual or apparent fairness of the adjudication. the four categories of communication deficiencies—involving disordered speech, an inability to be understood by courtroom actors, an inability to communicate in a timely fashion within the particular context of trial, and suboptimal advocacy—hold varying relationships to mental illness and cognitive impairment and thus offer differing implications for a defendant’s autonomous potential. they also differ in the extent to which they may be ameliorated by standby or hybrid counsel and so vary in their necessary relationship to the fairness or accuracy of an adjudication. after evaluating the constitutional significance of each subset of communication impairment, this part concludes by exploring the implications for existing state representational competence standards. it also proposes a two-part representational competence standard that coheres with supreme court precedent and the values animating representational competence.” id. at 2157as noted by professor johnston, iowa addressed competence for self-representation in state v. jason, 779 n.w.2d 66 (iowa ct. app.2009). “we emphasize that the issue to be decided on remand is not whether the defendant lacked the technical legal skill or knowledge to conduct the trial proceedings effectively without counsel…. that fact, however, has no bearing on whether he was competent to represent himself for purposes of edwards. rather, the determination of his competence or lack thereof must be predicated solely on his ability to ‘carry out the basic tasks needed to present his own defense without the help of counsel’; [edwards, 554 u.s. at ––––, 128 s. ct. at 2386, 171 l.ed.2d at 356]; notwithstanding any mental incapacity or impairment serious enough to call that ability into question. of course, in making this determination, the trial court should consider the manner in which the defendant conducted the trial proceedings and whether he grasped the issues pertinent to those proceedings, along with his ability to communicate coherently with the court and the jury.” state v. connor, 973 a.2d 627, 657 (conn. 2009). 80 indiana health law review [vol. 16:67 although patient one never reached the issue of self-representation due to the civil commitment proceedings, it is worthy to note because of the court’s missed opportunity: rendering a serious inquiry into patient one’s mental health status. a protocol should be developed for trial courts to implement when an individual appearing before it requests self-representation. it should include an inquiry into the defendant’s current mental health history as well as the appointment of an expert to evaluate the defendant’s capacity for self-representation. c. hope (maybe?) john e. baron on january 6, 2015, the medical staff at the jail where patient one was detained filed an application for civil commitment.69 in a letter attached to an affidavit requesting the civil commitment, a doctor noted the patient has: [a] history of schizophrenia, hypertension, hypothyroidism, gerd, hyperlipidemia and diabetes (ii). [patient one is] currently not oriented to place, person or time, delusional and at times irritable & unpredictable. it is difficult to engage [patient one] in services provided at the jail due to his current symptoms and non-compliance with medication.70 the patient was appointed an attorney,71 and committed to a medical facility from the jail.72 an additional hearing was set for january 12, 2015.73 69. application alleging serious mental impairment pursuant to iowa code section 229.6 (jan. 6, 2015), source available from author or ihlr upon request; see iowa code § 229.6 1 for proceedings for the involuntary hospitalization of an individual. the application included: “2. the application shall: a. state the applicant’s belief that the respondent is a person who presents a danger to self or others and lacks judgmental capacity due to either of the following: (1) a substance-related disorder as defined in section 125.2. (2) a serious mental impairment as defined in section 229.1. b. state facts in support of each belief described in paragraph ‘a’. c. be accompanied by any of the following: (1) a written statement of a licensed physician in support of the application. (2) one or more supporting affidavits otherwise corroborating the application. (3) corroborative information obtained and reduced to writing by the clerk or the clerk’s designee, but only when circumstances make it infeasible to comply with, or when the clerk considers it appropriate to supplement the information supplied pursuant to, either subparagraph (1) or (2). see iowa code §229.6 (2).” 70. affidavit in support of application alleging serious mental impairment pursuant to iowa code section 229.6 at 2, (jan. 6, 2015), source available from author or ihlr upon request. 71. order appointing counsel (jan. 7, 2015), source available from author or ihlr upon request. 72. order for immediate custody (jan. 7, 2015) , source available from author or ihlr upon request. 73. notice to respondent, order setting hearing (jan. 7, 2015) , source available from author or ihlr upon request. 2018] patient one: an exploration of criminal justice and mental health 81 d. taking a breath at this point, there are two cases pending: (1) the criminal case74 and (2) the civil commitment.75 the bad news is the patient was arrested at his residential facility under circumstances that would indicate he was suffering from mental disease. patient one was not appointed an attorney, and the case proceeded to an arraignment on the criminal case.76 the good news is that within two weeks, medical personal at the jail facility instituted civil commitment proceedings, appointed patient one counsel, and had a preliminary diagnosis of schizophrenia with a treatment plan in place, subject to additional judicial review.77 it would appear any deficiencies in one case would correct the other. in other words—ideally—the court systems would communicate with each other. in the criminal case, the fact that the patient had a serious psychiatric condition, which is relevant in the civil commitment proceeding, could impact the criminal case. certainly, competency is an issue in the criminal case, not to mention defenses of insanity or diminished responsibility. that did not happen. the two court systems failed to communicate with one another. v. the mental health civil commitment proceeding in the history provided to the court in the physician’s report, the “presenting problem” section of the report states: [patient] cooperative and pleasant during assessment. [patient] does not know the date but is aware [he is] at [a local hospital]. [patient] signed [his] consent as “john barron.” [patient] says [patient one] is someone “i was hooked into. [patient] says [patient one] disappeared. [patient] also states “i am the lord and in the year of the angels created earth.” [patient] says [he] has a home in heaven and tomorrow [he] will be president. [patient] reports [he is] married and has 5,000,000,000 children. [patient] says [he has] been in jail because [he] got into a fight with a police officer. . . . [patient] is not compliant with [his] medications and has not been for at least 2-3 weeks.78 when asked if he has a religious preference, patient one said “let the people cry out.”79 from the attending psychiatrist section of the report it is indicated the patient was “well known” to the psychiatrist due to at least one prior 74. (no. srcr282457) (filed jan. 6, 2015). 75. (no. mhmh017634) (filed jan. 6, 2015). 76. order of initial appearance (in-custody) (jan. 3, 2015), source available from author or ihlr upon request. 77. (no. mhmh017634) (filed jan. 6, 2015). 78. physician’s report of examination pursuant to section 229.10(2) of the code at 6 (jan. 12, 2015), source available from author or ihlr upon request. 79. id. at 3. 82 indiana health law review [vol. 16:67 hospitalization.80 as a result, patient one was civilly committed for treatment based on a finding by the court that he was “[s]eriously mentally impaired.”81 the civil commitment proceeded, along a parallel track with the criminal case, but with a very different objective: patient one’s treatment. after the initial commitment proceeding, the case was set for periodic review.82 the first report came within fifteen days of the court’s initial finding.83 the report indicated the diagnosis as “schizophrenia with hallucination, delusions, occasional agitation, disorganized thoughts and behavior.”84 in concluding the patient was incapable of “satisfying their needs for nourishment, clothing, essential medical care or shelter” for the reasonably foreseeable future.85 the report cited to the patient’s arrest, indicating he was, “aggressive towards police prior to admission and required tazing to contain his behavior.”86 80. id. at 7. 81. findings of fact and order pursuant to iowa code section 229.13 (jan. 12, 2015), source available from author or ihlr upon request. see iowa code § 229.1(20) (2017) (providing “seriously mentally impaired.” or “serious mental impairment” describes the condition of a person with mental illness and because of that illness lacks sufficient judgment to make responsible decisions with respect to the person’s hospitalization or treatment, and who because of that illness meets any of the following criteria: a. is likely to physically injure the person’s self or others if allowed to remain at liberty without treatment. b. is likely to inflict serious emotional injury on members of the person’s family or others who lack reasonable opportunity to avoid contact with the person with mental illness if the person with mental illness is allowed to remain at liberty without treatment. c. is unable to satisfy the person’s needs for nourishment, clothing, essential medical care, or shelter so that it is likely that the person will suffer physical injury, physical debilitation, or death.”). 82. iowa code § 229.15(1) (2017). “not more than thirty days after entry of an order for continued hospitalization of a patient under section 229.14, subsection 1, paragraph “b”, and thereafter at successive intervals of not more than sixty days continuing so long as involuntary hospitalization of the patient continues, the chief medical officer of the hospital shall report to the court which entered the order. the report shall be submitted in the manner required by section 229.14, shall state whether the patient’s condition has improved, remains unchanged, or has deteriorated, and shall indicate if possible the further length of time the patient will be required to remain at the hospital. the chief medical officer may at any time report to the court a finding as stated in section 229.14, subsection 1, and the court shall act upon the finding as required by section 229.14, subsection 2.” id. 83. chief medical officer’s report of psychiatric evaluation pursuant to section 229.14 the code. 15 day report at 1 (filed jan. 27, 2015) (no. mhmh017634). 84. chief medical officer’s report of psychiatric evaluation pursuant to section 229.14 the code. 15 day report at 1 para 8 (jan. 27, 2015), source available from author or ihlr upon request. 85. iowa code § 229.1(20.c) (2018). 86. medical officer’s report at para. 11 (jan. 27, 2015), source available from author or ihlr upon request. 2018] patient one: an exploration of criminal justice and mental health 83 the next report was filed on february 5, 2015. the report indicated patient one was receiving “structure, supportive therapy, medications, behavioral redirection, and social work intervention.”87 it again references a history of patient one’s “treatment for schizophrenia”88 the report concludes, “patient remains paranoid and delusional. not cooperative with attempts towards discharge planning. continues with extremely poor insight into illness and need for treatment.”89 as before, the court entered an order for continued hospitalization.90 a thirty-day report was filed on march 27, 2015, with the same effect.91 the court entered an order for continued hospitalization.92 in the order, the court authorized a sixty-day evaluation.93 on may 26, 2015, as required by the treating physician, a report was filed to the court indicating, despite treatment with “supportive therapy” and being medicated with “haldol94 [and] seroquel,95“ the patient should remain 87. medical officer’s report at para 1 (feb. 5, 2015), source available from author or ihlr upon request. 88. medical officer’s report at para. 3 (feb. 5, 2015), source available from author or ihlr upon request. 89. medical officer’s report at para. 15 (feb 5, 2015), source available from author or ihlr upon request. 90. order for continued hospitalization (mar. 27, 2015), source available from author or ihlr upon request. 91. medical officer’s report (mar. 27, 2015), source available from author or ihlr upon request. 92. order for continued hospitalization (mar. 27, 2015), source available from author or ihlr upon request. 93. order for continued hospitalization (mar. 27, 2015), source available from author or ihlr upon request. 94. u.s. nat’l library of medicine, medline plus: haloperidol (2018), https://medlineplus.gov/druginfo/meds/a682180.html, https://perma.cc/m6ebpkz3. “haloperidol is used to treat psychotic disorders (conditions that cause difficulty telling the difference between things or ideas that are real and things or ideas that are not real). haloperidol is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in adults and children who have tourette’s disorder (condition characterized by motor or verbal tics). haloperidol is also used to treat severe behavioral problems such as explosive, aggressive behavior or hyperactivity in children who cannot be treated with psychotherapy or with other medications. haloperidol is in a group of medications called conventional antipsychotics. it works by decreasing abnormal excitement in the brain.” id. 95. u.s. food & drug admin., medication guide: seroquel (2013), https://www.fda. gov/downloads/drugs/drugsafety/ucm089126.pdf, https://perma.cc/tq62-4xk5. “seroquel is a prescription medicine used to treat: schizophrenia in people 13 years of age or older; bipolar disorder in adults, including: depressive episodes associated with bipolar disorder, manic episodes associated with bipolar i disorder alone or with lithium or divalproex, [and] long-term treatment of bipolar i disorder with lithium or divalproex; manic episodes associated with bipolar i disorder 84 indiana health law review [vol. 16:67 hospitalized.96 the report concludes, “patient remains delusional, but improved over admission. however, [patient] required support and structure to maintain this improvement and this is not currently available in the community.”97 the court entered an order requiring an additional report be filed with the court in 30 days.98 the next day on may 27, 2015. the patient was discharged from one hospital and transferred to a long-term care facility.99 in the discharge report, the treating physician notes “patient is improved over admission. [he] has been accepted at the . . . center for long term placement and is appropriate for that level of support and supervision at this time.”100 on may 27, 2017, patient one was transferred to long-term care facility with an additional thirty-day report to filed by his new treating physician.101after being prompted by the court,102 an additional report was filed by the long-term care facility. the report notes the patient condition “remains unchanged.”103 the court entered another order continuing the outside placement, this time requiring a ninety-day report to the court.104 in september 2015, at the mental health advocate’s request, the court entered an order appointing an advocate in [] county, iowa.105 on the same date, the court entered a notification of the court’s intent to transfer venue to [a different] county.106 the court also continued the patient’s hospitalization.107 on october in children ages 10 to 17 years old.” id. 96. medical officer’s report at para.14(c) (may 26, 2015), source available from author or ihlr upon request. 97. medical officer’s report at para. 15 (may 26, 2015), source available from author or ihlr upon request. 98. order for continued hospitalization (may 26, 2015), source available from author or ihlr upon request. 99. order for transport, mhmh017634 (may 27, 2015), source available from author or ihlr upon request. 100. medical officer’s report at para. 15 (may 26, 2015), source available from author or ihlr upon request. 101. order transferring respondent inpatient to a facility outside the hospital (may 27, 2015), source available from author or ihlr upon request. as will be noted, his bond was posted in the criminal case on may 20, 2015. if his bond had not been posted, patient one would have discharged to the custody of the jail. 102. notice to comply with periodic reports (june 29, 2015), source available from author or ihlr upon request. 103. periodic report (june 29, 2015), source available from author or ihlr upon request. 104. order continuing inpatient to a facility outside the hospital (july 1. 2015), source available from author or ihlr upon request. 105. memorandum requesting new advocate be appointed; memorandum requesting the case be transferred (sept. 22, 2015); order appointing advocate (sept. 22, 2015), source available from author or ihlr upon request. 106. notification of intent to transfer venue (sept. 22, 2015), source available from author or ihlr upon request. 107. order continuing inpatient to facility outside the hospital (sept. 22, 2015), source available from author or ihlr upon request. 2018] patient one: an exploration of criminal justice and mental health 85 7, 2015, venue in patient one’s case was transferred to [the different] county.108 vi. two parallel universes while there is a sizeable debate about parallel universes in physics, there is no doubt they exist in the form of two separate tracks: the criminal case and the civil commitment case for patient one. a. the criminal case the time limits for discovery and speedy trial continued to run for the second month of patient one’s incarceration. no order suspending the proceedings, which could take place under the competency statute, was issued, even though the civil commitment proceedings were running concurrently with the criminal case.109 the significance of not suspending the criminal proceeding puts pressure on the state in order to resolve the criminal case. ordinarily, the state is obligated to take the case to trial within 135 days of the arrest and initial appearance of the defendant.110 most criminal cases where the defendant is incarcerated and is charged with a serious misdemeanor are disposed of within approximately ninety days. if an order suspending the criminal proceeding was issued, and patient one was evaluated for competency, the initial hearing would take place within fourteen days.111 if the patient is found incompetent by a preponderance of evidence, the defendant could be committed for treatment to restore competency.112 a follow-up report is required initially within thirty days113 and 108. change of venue (oct. 7, 2015), source available from author or ihlr upon request. 109. iowa code § 812.3(1) (2017) “if at any stage of a criminal proceeding the defendant or the defendant’s attorney, upon application to the court, alleges specific facts showing that the defendant is suffering from a mental disorder which prevents the defendant from appreciating the charge, understanding the proceedings, or assisting effectively in the defense, the court shall suspend further proceedings and determine if probable cause exists to sustain the allegations.” id. 110. the 135-day window is the result of the combinations of two rules of iowa criminal procedure. the first rule, iowa r. crim. p. 2.33(2)(a), provides that “[w]hen an adult is arrested for the commission of a public offense . . . and an indictment is not found against the defendant within forty-five days, the court must order the prosecution to be dismissed, unless good cause to the contrary is shown or the defendant waives the defendant’s right thereto.” the second rule, iowa r. crim. p. 2.33(2)(b), provides that “[i]f a defendant indicted for a public offense has not waived the defendant’s right to a speedy trial the defendant must be brought to trial within ninety days after indictment is found or the court must order the indictment to be dismissed unless good cause to the contrary be shown.” ninety days plus forty-five days is 135 days. 111. iowa code § 812.4(1) (2018). 112. iowa code § 812.4 (2018). 113. iowa code § 812.7 (2018). 86 indiana health law review [vol. 16:67 every sixty days thereafter114 until there is finding of restoration of competency,115 or if there is a finding that there is no substantial probability of restoration of competency, the court shall dismiss the criminal case.116 a person could be held for a total of eighteen months from the day of finding the person incompetent, but no more than the maximum time of incarceration for the offense the patient is charged.117 in patient one’s case, a period of not more than one year.118 patient one was held to answer for the criminal charges for 327 days.119 patient one’s family posted bond on may 21, 2015, or 140 days after his arrest. as previously noted, this allowed him to be transferred into a long-term care facility, rather than returning to the jail.120 patient one had forty days to file pre-trial motions from his arraignment,121 which occurred on february 18, 2015. the public defender’s office was appointed to represent the patient at the arraignment.122 the patient acknowledged the receipt of the trial information by again signing, “john barron.”123 a pre-trial conference was set for february 27, 2015, and a trial date was set for march 30, 2015. the next day, the state public defender withdrew from the case, and new counsel was appointed.124 a request to dismiss the criminal case was sent to the prosecuting attorney on march 12, 2015.125 on march 20, 2015, defense counsel in the criminal case moved to continue the pre-trial conference on the grounds that the defendant was civilly committed and was receiving treatment in a local hospital.126 the defendant did not waive speedy trial or ask for a competency examination, holding the state to 114. iowa code § 812.7 (2018). 115. iowa code § 812.8 (2018). 116. iowa code § 812.7 (2018). 117. iowa code § 812.9 (2018). 118. iowa code § 903.1(1)(b) (2018). 119. january 3, 2015, through november 23, 2015. criminal complaint (jan. 3, 2015), source available from author or ihlr upon request; order of dismissal (nov. 24, 2015), source available from author or ihlr upon request. 120. surety bond (may 21, 2015), source available from author or ihlr upon request (noting that his bond was posted in the criminal case on may 20, 2015. had it not been he would have been discharged to the custody of the jail.); order for transport (no. 05771-mhmh017634). 121. iowa r. crim. p. 2.11(4) (providing that “time of filing. motions hereunder, except motions in limine, shall be filed when the grounds therefor reasonably appear but no later than 40 days after arraignment….”). 122. order for appointment of counsel at 1 (feb. 18, 2015), source available from author or ihlr upon request. 123. receipt of copy of trial information & minutes of testimony by defendant at 2 (feb. 18, 2015), source available from author or ihlr upon request. 124. order granting public defender’s motion to withdraw due to a lack of staff (feb. 19, 2015), source available from author or ihlr upon request. 125. email to the prosecutor (mar. 12, 2015), source available from author or ihlr upon request. 126. motion to continue trial dates (mar. 20, 2015), source available from author or ihlr upon request. 2018] patient one: an exploration of criminal justice and mental health 87 the obligation to bring the defendant to trial within the 135-day period, or 90 days from the date the state filed the trial information.127 that would require the state to try the defendant by april 30, 2015. patient one’s total time of incarceration would have been 118 days.128 finally, on april 9, 2015, defense counsel in the criminal case filed an application for a competency examination, and the court suspended the proceedings on april 10, 2015. a letter from the treating physician was filed on may 21, 2015, which stated the following: [the patient] has an extensive history of schizophrenia and has been hospitalized numerous times in the past, including in [three other cities], and three times in the past two years at [a local hospital]. [the patient] is frequently non-compliant with oral medications. at his baseline, [the patient] is psychotic with chronic auditory hallucinations and delusions. currently, he believes that he is to become the first self-appointed president of the united states, and says he must get to washington d.c. as soon as he is discharged. prior to this hospitalization, [the patient] was involved in an altercation with police which resulted in misdemeanor charges being brought against him. [the patient] has remained delusional about this event from the time of his admission to today. [the patient] states that . . . he was only defending himself. [patient one] has not wavered from that position. i believe [the patient] is not able to understand the charges against him or participate in his own defense due to his mental illness. [the patient] is [sic] significantly improved over the time of admission, and has demonstrated no aggression towards anyone since his admission. [the patient] is currently calm, pleasant, and friendly. however, he remains very delusional, and continues with chronic auditory hallucinations. given [the patient’s] history and experience working with [the patient] over the last two years, i am confident that [the patient] is extremely unlikely to improve to a point where he would be competent to participate appropriately in this criminal process. 127. this occurred on january 30, 2015 (iowa r. crim. proc. r 2.33(2)(a)-(b) allows the state 45 days from the date of arrest to file trial information, and then 90 days from the date trial information is filed to bring him to trial. if trial information is filed before 45 days, the 90-day rule is triggered. a waiver is an affirmative duty. since patient one did not waive, the speedy trial rule was triggered. patient one did not ask for a competency examination because he was pro se at that time. eventually, when counsel was appointed, counsel filed for a competency exam under chapter 812.3(2) under the iowa code, which suspends all the time provisions provided in the iowa rules of criminal procedure. (45+90 =135 days). iowa r. crim. p. 2.33(2)(a)-(b)). 128. january 3, 2015 through april 30, 2015. 88 indiana health law review [vol. 16:67 [local hospital] staff has worked to find an appropriate alternative to [the patient’s] previous placement. [the patient] has now been accepted by the . . . center for admission to their facility pending the outcome of the criminal process, and finalizing of the financial arrangements. [patient one’s] guardian has approved this plan. i request that the court consider dropping the misdemeanor charges against [the patient]. in my clinical opinion, [the patient] is not restorable to competency. he has been hospitalized behind locked doors since early january of 2015. there is little to suggest that the public good would be further served from a longer period of containment for [the patient]. at this time, there is no evidence that [the patient] is acutely dangerous, and [the patient] has been stabilized on long acting injectable medication to help ensure his adherence with treatment.129 although the may 5, 2015 letter answers all the pertinent legal questions posed by a competency examination, the case was continued until november of that year: 1. did the defendant suffer from a “mental disorder”?130 yes. the patient “has an extensive history of schizophrenia and has been hospitalized numerous times in the past . . .”131 2. does the mental disorder prevent the defendant from “appreciating the charge, understanding the proceedings, or assisting effectively in the defense”?132 yes. patient one’s treating physician stated, “i believe [the patient] is not able to understand the charges against him or participate in his own defense due to his mental illness.”133 3. is there “no substantial probability that the defendant will be restored to competency in a reasonable amount of time”?134 yes. it is the physician’s opinion that “the patient is not restorable to competency.”135 in three subsequent reports, the treating physician found no change in the patient’s mental health status. the first report indicated the patient’s “mental stability as having auditory hallucinations and delusions as part of [his] daily life with little improvement in the future.”136 the second report indicated the patient “…is diagnosed with schizophrenia…has frequent auditory hallucinations, delusions, disorganized 129. letter to the district judge (may 5, 2015), source available from author or ihlr upon request. 130. iowa code § 812.3(2) (2018). 131. letter to the district judge, supra note 129. 132. iowa code § 812.3(2) (2018). 133. letter to the district judge, supra note 129. 134. iowa code § 812.8(8) (2018). 135. letter from janice landy, md, section chief for behavioral health, broadlawns med. ctr., to judge (may 21, 2015), source available from author or ihlr upon request. 136. letter from james brooks, md, psychiatrist, davis ctr. and life sols. behavioral health, to judge (june 22, 2015), source available from author or ihlr upon request. 2018] patient one: an exploration of criminal justice and mental health 89 thought patterns.”137 the final report states the patient, “is diagnosed with schizophrenia…[the patient] would not effectively assist in his defense due to his frequent auditory hallucinations, delusions and disorganized thought pattern[]…[the patient believes] that he is the president of the united states and [the patient’s] name is jon barron.”138 the criminal case was dismissed on november 23, 2015. what happened between counsel’s appearance on february 20, 2015, and dismissal entered on november 23, 2015, is typical of the delays that occur when a criminal case intersects with a civil commitment order. b. disincentive to resolve mental health issues a defendant charged in a criminal case has a significantly shorter incarceration than a defendant who has proceedings suspended due to incapacity to stand trial. as noted above, the maximum window for a prosecution in a criminal case is 135 days.139 in patient’s one’s criminal case, his incarceration would have been a maximum of 118 days.140 if patient one would have taken the plea offer at the arraignment, which was a one-year suspended sentence with probation,141 patient one would have been released on february 18, 2015, fortysix days after his arrest. by raising the issue of patient one’s competency, defense counsel has increased patient one’s incarceration in either the jail for the criminal proceedings or inpatient treatment for the civil commitment proceeding. c. lack of communication between civil commitment and criminal courts after the civil commitment proceeding had been initiated, and the defendant was transported to a local hospital’s psychiatric unit, there was no communication between the mental health court and the criminal court. this is especially concerning since two judges, two assistant county attorneys, and an attorney appointed to represent patient one in the civil commitment proceeding were involved. a simple solution would be to link the two systems. practically speaking, this would make available all filings in the mental health court system to the actors in the criminal court system. requiring that counsel be appointed in the criminal case, at least on a stand-by basis, would help assure expediting competency questions. it would be fair to assume that an individual’s inability to manage 137. letter from james brooks, supra note 136. 138. id. 139. iowa r. crim. p. 2. 33. this number comes from forty-five days from the date of arrest and appearance to file the trial information plus ninety days from the filing of the trial information to trial. 140. patient one case supra note 126 (the trial information was filed january 30, 2015, for twenty-eight days plus the ninety days for a period ending april 30, 2015). 141. trial information (jan. 30, 2015), source available from author or ihlr upon request (discusses the plea offer). 90 indiana health law review [vol. 16:67 basic health care142 would make it implausible that the individual could appreciate charges, understand the proceedings, or effectively assist counsel in the criminal justice system.143 any privacy concerns could be addressed by limiting access to sensitive information. in iowa, amending the civil commitment statute and the competency statutes would provide the best vehicle to accomplish sharing information regarding mental health status.144 d. aftercare & guardianship one of the greatest challenges at the intersection of mental health and the criminal justice system is the constant nature of the former and the terminal nature of the latter. in the criminal justice system, there is a final event: a term of probation is discharged, a term of incarceration is completed, or a case is dismissed. each time a terminal event occurs and coincides with an individual who has an underlying mental health issue, the individual is typically released without a plan for aftercare. the system is out of the picture, yet the underlying medical condition persists. this significantly increases the rate of recidivism. patient one is fortunate. he had a guardian involved in his case, so aftercare was eventually provided. this was a matter of good fortune rather than by design of the criminal justice system. in most situations, aftercare is not anticipated let alone provided. in fact, it seems to be discouraged. as demonstrated in patient one’s case, the importance of having a guardian cannot be minimized. the guardian interceded in posting the bond and making arrangements for aftercare upon the dismissal of the criminal case. if no guardian was appointed, patient one would have returned to the custody of the local jail 142. iowa code ann. § 229.6(2)(a)(2) (west 2018) (effective july 1, 2017). in iowa, an application for order of involuntary hospitalization requires an allegation of a serious mental impairment. id. see iowa code ann. § 229.1(20) (west 2018) (effective july 1, 2018): “seriously mentally impaired” or “serious mental impairment” describes the condition of a person with mental illness and because of that illness lacks sufficient judgment to make responsible decisions with respect to the person’s hospitalization or treatment, and who because of that illness meets any of the following criteria: a. is likely to physically injure the person’s self or others if allowed to remain at liberty without treatment. b. is likely to inflict serious emotional injury on members of the person’s family or others who lack reasonable opportunity to avoid contact with the person with mental illness if the person with mental illness is allowed to remain at liberty without treatment. c. is unable to satisfy the person’s needs for nourishment, clothing, essential medical care, or shelter so that it is likely that the person will suffer physical injury, physical debilitation, or death. 143. iowa code ann. § 812.3 (west 2018) (proposed feb. 23, 2017). 144. in patient one’s case, this would require sharing information between the local jail, the private contactor providing health care for inmates in the jail, the local hospital treating for mental health disorders, the mental health courts, and the criminal courts. 2018] patient one: an exploration of criminal justice and mental health 91 from a hospital setting for disposition of the criminal charges. a series of interviews took place between july and august of 2018 with patient one’s guardian; as a result, some important observations were made by the guardian.145 the onset of patient one’s symptoms began in his late teens or early twenties, where he was incapable of holding jobs and labored under the belief that he could make a living as a fur trapper.146 patient one’s symptoms included several delusions increasing in severity and length over time. in his late twenties, patient one required a number of psychiatric commitments. the guardian noted that one suggested change is the length of the emergency psychiatric commitment. increasing the term of the psychiatric commitment to a week or more would help to properly diagnose and adequately assess the needs of a patient. the guardian also suggested hiring more medical personnel who have sufficient training and experience to evaluate individuals with psychiatric disorders. it goes without saying that medical personnel should receive additional training in diagnosis and treatment in order to keep up to date. the guardian noted her frustration with the criminal justice system in dealing with her ward. she noted the indifference of local law enforcement in releasing her ward onto the street without any follow-up mental health treatment. as was previously mentioned in this article, training for law enforcement in recognizing mental health issues is imperative to the effective treatment of those who come into contact with law enforcement. the guardian also indicated what a relief it was for her when patient one was hospitalized until he turned sixty-five. this allowed the guardian to make arrangements for long-term care for her ward. the question is: what will happen when the guardian is no longer able to care for her ward? who will succeed her as his guardian? in this regard, patient one’s disease is one that will last decades. in his case—from his late teens to currently sixty-eight—a half century of care. this point is often lost on individuals who do not regularly interact with individuals who have serious mental health issues. what will become of patient one when his guardian is gone? he is currently sixty-eight and she is seventy-four. vii. hipaa and state privacy statues: myths and magical thinking one impediment to sharing health care information is hipaa and state health care privacy statutes. the health insurance portability and accountability act (hipaa) was enacted by congress in 1996 with the goal of “ensur[ing] that individuals’ health information is properly protected while allowing the flow of 145. it should be noted that the guardian is a family member and is also a registered nurse. the guardianship was established in 1996. 146. the guardian estimated that patient one’s psychiatric issues were exacerbated by the death of his mother. he was the youngest of five children and the death occurred when he was fifteen years old. the family was also extremely poor. 92 indiana health law review [vol. 16:67 information needed to promote high-quality health care.”147 in spite of the claim that one of hipaa’s objectives is to simplify the exchange of patient information,148 it has turned into a tool that allows health care providers and their agents to bully individuals, conceal medical errors, and delay investigations into patients’ cases. there is nothing simple about hipaa. the potential penalties for wrongful disclosure of hipaa protected information are indeed onerous.149 section 1320d-6 creates an offense and penalties for “wrongful disclosure of individually identifiable health information.”150 under subsection (a) of the statute, a person commits the offense when, knowingly, one of the following elements is satisfied: “(1) [u]ses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person.”151 subsection (b) provides for the penalties, stating a person found in violation of the above statute shall: (1) be fined not more than $50,000, imprisoned not more than 1 year, or both; (2) if the offense is committed under false pretenses, be fined not more than $100,000, imprisoned not more than 5 years, or both; and (3) if the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, be fined not more than $250,000, imprisoned not more than 10 years, or both.152 in order for the penalties statute to apply, one must be a “covered entity” described in another provision of the statute.153 “the term ‘hipaa privacy regulation’ means the regulations promulgated by the secretary under this part and section 264 of the health insurance portability and accountability act of 147. sharyl j. nass et al., beyond the hipaa privacy rule: enhancing privacy, improving health through research 2 (2009), https://www.ncbi.nlm.nih.gov/books/ nbk9578/pdf/bookshelf_nbk9578.pdf [https://perma.cc/7vpd-zsjs]. 148. “the institute of medicine committee on health research and the privacy of health information . . . was charged with . . . assess[ing] whether the hipaa privacy rule is having an impact on the conduct of health research, defined broadly as ‘a systematic investigation, including research development, testing and evaluation, design to develop or contribute to generalizable knowledge.’ . . . the committee’s conclusion is that the hipaa privacy rule does not protect privacy as well as it should, and that, as currently implemented, the hipaa privacy rule impedes important health research.” id. 149. “criminal violations of hipaa are handled by the doj. as with the hipaa civil penalties, there are different levels of severity for criminal violations.” hipaa violations & enforcement, am. med. ass’n, https://www.ama-assn.org/practice-management/hipaa-violationsenforcement [https://perma.cc/qj8x-zezr]. 150. 42 u.s.c. § 1320d-6 (2018). 151. 42 u.s.c. § 1320d-6(a) (2018). 152. 42 u.s.c. § 1320d-6(b) (2018). 153. 42 u.s.c. § 1320d-6(a) (2018); 42 u.s.c. § 1320d-9(d) (2018). 2018] patient one: an exploration of criminal justice and mental health 93 1996 (42 u.s.c. 1320d-2 note).”154 that, in term, refers to an executive order, which provides, in part: hipaa applies only to “covered entities,” such as health care plans, providers, and clearinghouses. hipaa regulations therefore do not apply to other organizations and individuals that gain access to protected health information, including federal officials who gain access to health records during health oversight activities.155 which, in turn, leads to the code of federal regulation that states a covered entity refers to “(1) a health plan[,] (2) [a] health care clearinghouse[,] [or] (3) [a] health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter.156 it may also include: (2) a covered entity may be a business associate of another covered entity. (3) business associate includes: (i) a health information organization, e-prescribing gateway, or other person that provides data transmission services with respect to protected health information to a covered entity and that requires access on a routine basis to such protected health information. (ii) a person that offers a personal health record to one or more individuals on behalf of a covered entity. (iii) a subcontractor that creates, receives, maintains, or transmits protected health information on behalf of the business associate.157 the code defines disclosure as, “the release, transfer, provision of access to, or divulging in any manner of information outside the entity holding the information.”158 answering a fairly straightforward question: “what is a covered entity under hipaa?” requires navigating the enabling statutes, executive orders, and the code of federal regulations. this is not a simple task. likely, those unfamiliar with the law’s complexities and consequences would find it a daunting task to unearth. in 2014, propublica published an article entitled “are patient privacy laws being misused to protect medical centers.”159 in it, the author, charles ornstein, documents several situations where hipaa was used to shield medical institution rather than the patients hipaa was designed to protect. for example, threatening a mother with jail for photographing her son who was a patient at a medical 154. 42 u.s.c. § 1320d-9(b)(3). 155. to protect the privacy of protected health information in oversight investigations, 65 fed. reg. 81,321 (dec. 20, 2000). 156. 45 c.f.r. § 160.103 (2014). 157. id. 158. id. 159. charles ornstein, are patient privacy laws being misused to protect medical centers?, propublica (july 24, 2014, 11:30 am), https://www.propublica.org/article/who-do-federalprivacy-laws-protect-patients-or-medical-centers [https://perma.cc/v39s-rekm ]. 94 indiana health law review [vol. 16:67 facility160; a nursing home refusing to cooperate with the investigation of a rape against a resident161; and threatening whistle blowers at the department of veterans affairs.162 in some instances, medical providers even deny patients access to their own medical records. quoting devin mcgraw, former director of the health privacy project at the center for democracy and technology, as stating: “sometimes it’s really hard to tell whether people are just genuinely confused or misinformed, or whether they’re intentionally obfuscating.”163 probably the most egregious examples are when health care providers cite hipaa’s privacy provisions as prohibitions for disclosure to the patient—the opposite is true.164 a. bubble, bubble, toil and trouble165 adding state privacy provisions into the mix: hipaa compliance. hipaa provides that it supersedes any contrary provisions of state law. 42 u.s.c. § 1320d-7(a)(1) (2012). hipaa regulations have been described as “dense, complex, confusing and lengthy.” cohan v. ayabe, 132 haw. 408, 322 p.3d 948, 956 (2014). but, the parties in this case agree iowa law controls if it is “more stringent” in protecting mental health information than the privacy restrictions imposed under hipaa. see 45 c.f.r. § 160.203(b); holman v. rasak, 486 mich. 429, 785 n.w.2d 98, 111 (2010) (“[a]ny hipaa standard or requirement that is contrary to state law preempts state law, unless the state law is more stringent than hipaa. 45 c.f.r. 160.203.... more stringent means that the state law provides greater privacy protection than hipaa. 45 c.f.r. 160.202.”).166 160. id. (citing sarah okeson, secret video: mercy guard threatened photo-taking mom, springfield news-leader (july 18, 2014, 11:25 am) https://www.news-leader.com/story/ news/local/ozarks/2014/07/18/caught-camera-mercy-guard-chided-photo-taking-mom/12835341/ [https://perma.cc/sq6s-hnwl]). 161. id. (citing katie kustura & skyler swisher, daytona police, attorneys butt heads in investigation of possible sex crime at healthcare facility, daytona beach news j. (july 18, 2014, 10:36 pm), http://www.news-journalonline.com/news/20140718/daytona-police-attorneysbutt-heads-in-investigation-of-possible-sex-crime-at-healthcare-facility [https://perma.cc/xk7uzk8z]). 162. id. (citing joe davidson, va uses patient privacy to go after whistleblowers, critics say, washington post (july 17, 2017), https://www.washingtonpost.com/politics/federal_ government/va-uses-patient-privacy-to-go-after-whistleblowers-critics-say/2014/07/17/bafa7a020dcb-11e4-b8e5-d0de80767fc2_story.html?utm_term=.dc70e143c6c4 [https://perma.cc/jkb7gwkz]). 163. id. 164. id. 165. william shakespeare, macbeth act 4, sc. 1. 166. in re a.m., 856 n.w.2d 365, 379 (iowa 2014). 2018] patient one: an exploration of criminal justice and mental health 95 therefore, hipaa must also be read in conjunction with state privacy laws, and that if the state laws are more stringent, the state privacy law will prevail.167 for example, in iowa, that means analyzing two privacy statutes. the first statute deals with the general physician-patient or medical privilege.168 the second statute deals with mental health providers.169 the general physicianpatient privilege allows for disclosure of information in situations where the patient waives the privilege,170 or where the party to an action puts the underlying medical condition at issue in a civil action.171 pleading insanity or diminished responsibility in a criminal prosecution also waives the physician patient privilege.172 167. id. at 370 (“the parties agree that iowa law controls if it is more stringent than hipaa in protecting mental health information. we therefore examine the iowa enactments before turning to hipaa. we conclude the iowa protections are more stringent than hipaa and are dispositive.”). 168. iowa code § 622.10(1) (2018) (“a practicing attorney, counselor, physician, surgeon, physician assistant, advanced registered nurse practitioner, mental health professional, or the stenographer or confidential clerk of any such person, who obtains information by reason of the person’s employment, or a member of the clergy shall not be allowed, in giving testimony, to disclose any confidential communication properly entrusted to the person in the person’s professional capacity, and necessary and proper to enable the person to discharge the functions of the person’s office according to the usual course of practice or discipline.”). 169. iowa code § 228.2 (1) (2018) (“except as specifically authorized . . . or for the purposes of care coordination as defined . . . if not otherwise restricted by federal law or regulation, a mental health professional, data collector, or employee or agent of a mental health professional, of a data collector, or of or for a mental health facility shall not disclose or permit the disclosure of mental health information.”). 170. iowa code § 622.10(2) (2018). “the prohibition does not apply to cases where the person in whose favor the prohibition is made waives the rights conferred; nor does the prohibition apply to physicians or surgeons, physician assistants, advanced registered nurse practitioners, mental health professionals, or to the stenographer or confidential clerk of any physicians or surgeons, physician assistants, advanced registered nurse practitioners, or mental health professionals, in a civil action in which the condition of the person in whose favor the prohibition is made is an element or factor of the claim or defense of the person or of any party claiming through or under the person. the evidence is admissible upon trial of the action only as it relates to the condition alleged.”). 171. iowa code § 622.10(3) (2018). 172. state v. cole, 295 n.w.2d 29, 35-36 (iowa 1980). (“several courts have held that a plea of insanity or diminished capacity waives the privilege by putting the matter in issue . . . we believe the defense of diminished capacity waived the privilege here, even if it had existed, for the simple reason it would be incongruous to allow a party to put a matter in issue and then deny access of an opposing party to relevant information concerning it. id. our modern concept of criminal trials favors full disclosure of facts, within constitutional limitations, on both sides of the table. the ‘sporting’ theory of justice resulting from concealment and surprise is no longer the rule . . . even the most restrictive authorities would say cole would have waived the privilege by introducing 96 indiana health law review [vol. 16:67 although not specifically addressed within the statute, presumably by raising the issue of competency would also constitute a waiver.173 in fact, the competency statute requires the court to order a psychiatric examination with a subsequent report to be filed with the court174 with status reports to follow in the event the court finds the individual incompetent to stand trial.175 the second statute provides for the disclosure of mental health and psychological information acquired pursuant to a “court-ordered examination.”176 also, disclosure is permitted specifically in civil commitment proceedings.177 these are straightforward authorization to disclose information under the general title of the subsection on “compulsory disclosures.”178 arguably, the state privacy statutes in effect in iowa are easier to decipher than federal statutes and rules, but they could be improved significantly. evidence on it; our view that a waiver is effected by a plea of insanity or diminished capacity merely advances the timetable to permit adequate preparation and avoids the delay which might otherwise be required to meet the defense . . . (‘[r]equiring disclosure [by defendant] in advance merely regulates the procedure by which he presents his case.’).”); see also laurie k. dore, iowa practice evidence § 5.502:13 (7 vol.) (2016). 173. iowa code § 622.10(2) (2018). 174. iowa code § 812.3(2) (2018). (“upon a finding of probable cause sustaining the allegations, the court shall suspend further criminal proceedings and order the defendant to undergo a psychiatric evaluation to determine whether the defendant is suffering a mental disorder which prevents the defendant from appreciating the charge, understanding the proceedings, or assisting effectively in the defense. the order shall also authorize the evaluator to provide treatment necessary and appropriate to facilitate the evaluation. if an evaluation has been conducted within thirty days of the probable cause finding, the court is not required to order a new evaluation and may use the recent evaluation during a hearing under this chapter. any party is entitled to a separate psychiatric evaluation by a psychiatrist or licensed, doctorate-level psychologist of their own choosing.”) 175. iowa code § 812.7 (2018). (“the psychiatrist or licensed doctorate-level psychologist providing outpatient treatment to the defendant, or the director of the facility where the defendant is being held and treated pursuant to a court order, shall provide a written status report to the court regarding the defendant’s mental disorder within thirty days of the defendant’s placement pursuant to section 812.6. the report shall also state whether it appears that the defendant can be restored to competency in a reasonable amount of time. progress reports shall be provided to the court every sixty days or less thereafter until the defendant’s competency is restored or the placement of the defendant is terminated.”). 176. iowa code § 228.6 (2) (2018). (“mental health information acquired by a mental health professional pursuant to a court-ordered examination may be disclosed pursuant to court rules.”). id. 177. iowa code § 228.6(3) (2018). (“mental health information may be disclosed by a mental health professional if and to the extent necessary, to initiate or complete civil commitment proceedings under chapter 229.”). id. 178. iowa code § 228.6 (2018). 2018] patient one: an exploration of criminal justice and mental health 97 b. hipaa has been characterized as, “dense, complex, confusing and lengthy”179 so “the first thing we do, let’s kill all the lawyers”180 unfortunately for non-lawyer colleagues in the health profession, that is not a practical proposition. competing interests exist within the health care industry. if we take patient one and put him through the various represented interests illustrates the point. the health care facility would be the first entity that would have an interest. the second entity would be the local hospital where patient one was taken for treatment. the third would be the local jail where patient one was booked. the fourth would be the health care provider employed by the jail that instituted civil commitment proceedings. the fifth would be the local hospital where patient one was committed. the sixth and seventh would be the institution where patient one received treatment whose medical information was given to the local hospital. the final entity would be the health care provider he was transferred to as a result of the civil commitment. each one of the above institutions would be governed by hipaa and state privacy statutes. each would presumably be represented by counsel whose primary interest is protecting its legal interests, not necessarily the interests of the patients that hipaa was designed to protect. this creates divided loyalty with counsel. thus, lending hipaa to the critique that the providers are using it to guard themselves. this leads to inevitable threat first heard by sherlock holmes in the hound of baskervilles when someone outside the entity asks for patient information: sherlock: i never did ask, dr. franklyn. what is it exactly that you do here? doctor: oh, mr. holmes, i would love to tell you, but then, of course, i’d have to kill you. sherlock: that would be tremendously ambitious of you.181 whether the motive behind an individual’s denial of information is “genuinely confused or misinformed, or whether they’re intentionally obfuscating,” is irrelevant.182 the denial upon request of information is wrong. unfortunately, this is the default position for all entities covered by hipaa or state privacy laws when faced with such requests. viii. prognosis and conclusion a. short-term recommendations as previously noted, the current prison and jail populations across the united 179. in re a.m., 856 n.w.2d 365, 379 (iowa 2014) (citing cohan v. ayabe, 322 p.3d 948, 956 (2014)). 180. william shakespeare, henry vi act 4, sc. 2. 181. arthur conan doyle, the hound of baskervilles (1902). 182. charles ornstein, supra note 159. 98 indiana health law review [vol. 16:67 states are inundated with individuals who have serious mental illness.183 unless action is taken, the prognosis is dismissal. the first step is to identify those who have serious mental impairment. to that end, adequate training for dispatch and first responders is essential. not only is it necessary for those responders to be trained, it is critical they report those individuals who have identifiable mental health issues. forms for the report should be uniform and redundant. in other words—not only should the initial case report have an area designated for mental health, but all follow-up reports in the criminal and civil courts should be adapted to allow for the identification of persons with serious mental illness. this redundancy should encourage a system that double checks itself with each report or pleading. in all cases where an individual is taken to a hospital for treatment prior to incarceration, the hospital should be required to perform a records-check to establish a patient’s history prior to any discharge to police custody. the recordscheck should be incorporated into the transporting agency records, and then forwarded to court. court rules should be adopted to allow judges in the criminal court to trigger mental health evaluations for competency as early as the initial appearance. those rules should also allow criminal courts to initiate civil commitment proceedings. once triggered, the civil commitment proceeding should be attached to the criminal proceedings, running concurrently. privacy statutes should be amended to allow the flow of information between the civil commitment courts and criminal courts. this amendment would allow all actors in both systems access to the information. in the event of a civil commitment proceeding along with a criminal filing, there should be a joint hearing or joint hearings involving all parties on both proceedings so parties are able to coordinate with health care professionals as to the proposed plan of treatment. one goal in these recommendations is to shorten the time individuals with serious mental health issues spend incarcerated. additionally, this would incentivize defense attorneys to raise their client’s mental issues upfront, rather than feel reluctant because their client would spend more time if the issues went undisclosed. in cases like patient one’s—where competency will not be restored in the foreseeable future—the competency statutes should require the appointment of 183. incarceration nation, 45 am. psychological assn. 9, 56 (oct. 2014), http://www.apa. org/monitor/2014/10/incarceration.aspx/ [https://perma.cc/9hwk-565g]. “[t]he united states has only 5 percent of the world’s population, [yet] it has nearly 25 percent of its prisoners. while at least half of prisoners have some mental health concerns, about 10 percent to 25 percent of u.s. prisoners suffer from serious mental illnesses, such as major affective disorders or schizophrenia, the report finds.” see also sarah varney, by the numbers: mental illness behind bars, pub. broad. sys. (may 15, 2014, 6:39 pm), https://www.pbs.org/newshour/health/numbers-mentalillness-behind-bars/ [https://perma.cc/vp2p-hmhf]. “in state prisons, 73 percent of women and 55 of men have at least one mental health problem. in federal prisons, 61 percent of women and 44 percent of men. in local jails, 75 percent of women and 63 percent of men.” 2018] patient one: an exploration of criminal justice and mental health 99 a guardian or conservator prior to the discharge of the person and dismissal of the criminal proceeding. the guardianship and conservator provisions should be reconciled with the competency statute. currently in iowa, the burden to establish a guardian is clear and convincing evidence to establish “a person whose decision-making capacity is so impaired that the person is unable to care for the person’s personal safety or to attend to or provide for necessities for the person.”184 if a guardian has been appointed prior to the commencement of the criminal proceeding, the competency statute should be amended to create a presumption of incompetency rather than competency.185 it is inconceivable that a person who requires a guardian “to attend to or provide for [their] necessities” and still be competent to stand trial.186 currently, it is possible for a court to make a finding that an individual cannot make decisions regarding their basic life functions but they can effectively assist in their own defense. this reality defies logic. these adjustments could be made fairly quickly and with little legislative or judicial effort. furthermore, such changes would cause a reduction—albeit small—in the number of individuals with chronic mental illness in the criminal justice system. b. long-term recommendations three important steps must be taken to change hippa and its 184. in re guardianship of r.k., 913 n.w.2d 627 (table), 2018 wl 1182532, *1 (iowa ct. app. 2018) (citing iowa code § 633.552(2)(a)). 185. state v. lyman, 776 n.w.2d 865, 874 (iowa 2010). (“we presume a defendant is competent to stand trial. the defendant has the burden of proving his or her incompetency to stand trial by a preponderance of the evidence. if the evidence is in equipoise, the presumption of competency prevails. moreover, once a court finds a defendant competent to stand trial, the presumption of competency continues unless and until the defendant produces new evidence to the contrary.”). 186. state v. lyman, 776 n.w.2d 865 (iowa 2010). (“at common law, the state could not try a criminal defendant if that person’s mental condition was such that he or she lacked the capacity to understand the nature and object of the proceedings, to consult with counsel, and to assist in preparing a defense. the supreme court has stated the test to determine if a criminal defendant is competent to stand trial is whether the person “‘has sufficient present ability to consult with [counsel] with a reasonable degree of rational understanding—and whether [the person] has a rational as well as factual understanding of the proceedings.”’ (citing dusky v. united states, 362 u.s. 402, 402, 80 s.ct. 788, 789, 4 l.ed.2d 824, 825 (1960) (per curiam)). “in iowa, we define the test as whether ‘the defendant is suffering from a mental disorder which prevents the defendant from appreciating the charge, understanding the proceedings, or assisting effectively in the defense.’” (citing iowa code § 812.3(1); accord lyon, 293 n.w.2d at 9)). “the common thread running through these tests is that a criminal defendant must be able to effectively assist counsel in his or her defense. see also iowa code 812.3.” id. at 873-74. it also of note the burden of proof in a competency proceeding is a preponderance of evidence. 100 indiana health law review [vol. 16:67 implementation. first, hipaa must be revised with the intention of easing navigation for a lay person. second, policy goals must shift in order to discourage the common negative response by health care providers by their attorneys when asked for information by creating an express exemption for actors in the criminal justice system that allows them to share information among themselves. finally, a panel of medical professionals should be established to review hipaa and state privacy statutes on a periodic basis to examine them for elimination of unnecessarily complex and confusing language. these tasks, of course, will be daunting given the number of interest groups with conflicting goals in hipaa’s revision. the most important and long-term recommendation is the creation of body composed of mental health professionals that would meet on a periodic basis and evaluate all aspects of the mental health system in order to make recommendations regarding standards for competency, insanity, and diminished responsibility, as well as the procedures used by the criminal justice system. if policy makers persist in the repeated fallacy of trying to treat a mental health and medical problem with legal solutions, the criminal justice system will eventually collapse under its own weight. from (moral) status (of the frozen embryo) to (relational) contract and back again to (relational moral) status yehezkel margalit* abstract the existing hundreds of thousands of unused frozen embryos, coupled with the skyrocketing rate of divorce, raise numerous moral, legal, social, and religious dilemmas. among the most daunting problems are the moral and legal status of the frozen embryo; what should its fate be in the event of conflicts between the progenitors?; and whether contractual regulation of frozen embryos is valid and enforceable. this article applies relational ethics, drawing on, inter alia, the relational contract to resolve such intertwined dilemmas. applying this theory, this article will challenge the conventional dichotomous conceptualization of the frozen embryo as either a person or a nonperson. this article will discuss why the legal and moral status of the frozen embryo should be determined as a derivative of the desired or undesired relationship between the progenitors, articulated in a mandatory disposition agreement. the progenitor who is interested in using the frozen embryo and bringing the child into the world defines it as a person, whereas the progenitor who opposes its usage determines its status as a nonperson – an object. consequently, this article argues that in the event of an explicit disposition agreement, the contract should govern whether the frozen embryo will be used, discarded, adopted and/or earmarked for research. the relational contract provides adequate contractual devices to address any problems arising from changed circumstances or changes of heart. in those cases where there is no explicit disposition agreement, or when the explicit agreement does not stipulate what should be done with the embryos under special or unanticipated circumstances, the party interested in using the embryo should prevail. the recalcitrant progenitor, who is not interested in using the embryo and becoming a parent, should not be subject to a legal determination of parental status and its attendant responsibilities. * visiting research scholar, new york university law school (2011–2012); associate professor, netanya academic college, and bar-ilan university; phd (law); m.a. (law); ll.b. bar-ilan university. author of the books the jewish family – between family law and contract law (2017); determining legal parentage – between family law and contract law (2019); parent-child relationships between family law and contract law (bar-ilan university press, 2022) (heb.) (forthcoming). thanks to i. glenn cohen, jonathan herring, pamela laufer-ukeles, netanel lipshitz, efrat ram-tiktin and nitzan rimon-zarfaty for their useful comments. the article was presented to bar-ilan university’s interdisciplinary research group on the ethics of cryopreserved fertilized embryos in may 2021; the israeli contract forum, zefat academic college, israel in june 2021; the law & society conference, peres academic center; the association for israel studies, bar-ilan university, both in june 2022. 258 indiana health law review [vol. 20:257 i. introduction in october 2020, scientific and social media headlines announced that a miracle had occurred in tennessee when a baby girl, molly gibson, was born after having been a frozen embryo for twenty-seven years, setting a new record for the longest frozen embryo to have resulted in a birth.1 this new world record broke the previous record set by molly’s older sister, emma, who was also adopted by the same parents, tina and ben gibson, after having been frozen as an embryo for twenty-four years.2 the two sibling girls had been created in october 1992, when tina, the mother, was only one and a half years old.3 in our “frozen age,” it will not be surprising if in the near future, the new world record will be much longer – perhaps even generations longer. this breathtaking biomedical innovation highlighted the dilemmas that can occur in today’s extensive preservation and donation of frozen embryos across the united states as well as in other countries throughout the world. in the u.s. context, according to the most recent official survey, based on the cdc’s 2018 fertility clinic success rates report, there were 306,197 assisted reproductive technologies (“art”) cycles performed at 456 reporting clinics in the united states during 2018, resulting in 73,831 live births (deliveries of one or more living infants), for a total of 81,478 live-born infants. according to another estimate, “there are more than 620,000 cryo-preserved embryos in storage in the united states.”4 sadly, however, even these innovative fertility treatments, not to mention innovations leading to ectogenesis – an artificial womb5 – have not resolved the unresolvable moral and legal debates regarding the status of both the frozen embryo and the fetus. consequently, even early in 2020, an arizona court 1. holly honderich, baby girl born from record-setting 27-year-old embryo, bbc news (feb. 12, 2020), https://www.bbc.com/news/world-us-canada-55164607 [https://perma.cc/ans7c54u]. 2. see caroline a. harman, defining the third way the special-respect legal status of frozen embryos, 26 geo. mason l. rev. 515, 515 (2018). 3. see ayelet blecher-prigat, echoes of nonmarriage, 51 ariz. st. l.j. 1213, 1245-46 (2019); ruth zafran, reconceiving legal siblinghood, 71 hastings l.j. 749, 749 (2019-2020); laura t. kessler, family law by the numbers: the story that casebooks tell, 62 ariz. l. rev. 903, 917-18 (2020). 4. see ctrs. disease control & prevention, the 2018 assisted reprod. tech. nat’l summary rep. (2018), https://www.cdc.gov/art/pdf/2018-report/art-2018-national-summary508.pdf [https://perma.cc/p5b3-h7mp]; harman, supra note 2, at 518. there are an estimated 800,000 frozen embryos, see frozen embryos: the law at a crossroads (jan. 18, 2023), h t tps:/ /www.m-mtlaw.com/insight-news/frozen-embryos-the-law-at-a-crossroads/ [https://perma.cc/99e8-qjdf] for the updated evaluation. 5. eric steiger, not of woman born: how ectogenesis will change the way we view viability, birth, and the status of the unborn, 23 j. l. & health 143, 143 (2010); jessica h. schultz, development of ectogenesis: how will artificial wombs affect the legal status of a fetus or embryo?, 84 chi.-kent l. rev. 877, 877 (2010); glenn cohen, artificial wombs and abortion rights, 47 hastings ctr. rep. 1,1 (2017). 2023] from (moral) status (of the frozen embryo) 259 could not precisely define the moral status of the frozen embryo,6 settling on an “interim category that entitles them to special respect because of their potential for human life.”7 this article challenges the conventional conceptualization of the frozen embryo and the fetus in dichotomous terms as either having or not having personhood status.8 between these two extreme poles, there is room for a more nuanced and relational moral status. the notion of “relational status” has long been the subject of a vast body of scholarly work, but the phrase “relational moral status” represents a much newer idea, having been raised during the past decade in the legal and ethics fields as well as others.9 nevertheless, both concepts remain difficult to define precisely. this article offers a novel approach, using intent and contract, especially the relational contract, to define the relative moral and legal status of the frozen embryo (and the fetus). under this approach, the two individuals involved in the fertility treatments should define the relational status of their own frozen embryo as they prefer to conceptualize their relationships with it through private, contractual arrangements.10 6. the need for a definitive status in this issue was extensively discussed by bill e. davidoff, frozen embryos: a need for thawing in the legislative process, 47 smu l. rev. 131, 135-37 (1993). 7. terrell v. torres, no. cv-19-0106-pr, 2020 ariz. lexis 25(jan. 23, 2020), quoting davis v. davis, infra note 35, at 597. for an academic discussion of this recent verdict, see sarah b. kirschbaum, who gets the frozen embryos during a divorce: a case for the contemporaneous consent approach, 21 n.c. j. l. & tech. 113, 133 (2019); melissa b. herrera, arizona gamete donor law: a call for recognizing women’s asymmetrical property interest in pre-embryo disposition disputes, 30 hastings women’s l.j. 119, 128-31 (2019); catherine wheatley, arizona’s torres v. terrell and section 318.03: the wild west of pre-embryo disposition, 95 ind. l.j. 299, 299 (2020). 8. see roger j. magnuson & joshua m. lederman, aristotle, abortion, and fetal rights, 33 wm. mitchell l. rev. 767, 769-85 (2007); lee r. collins & susan l. crockin, fighting ‘personhood’ initiatives in the united states, 24 reprod. biomed. online 689, 689 (2012); j. f. will, beyond abortion: why the personhood movement implicates reproductive choice, 39 am. j. l. & med. 573, 573 (2013). 9. see, e.g., in the context of the moral status of the fetus and the frozen embryo catriona mackenzie, abortion and embodiment, 70(2) austl. j. phil. 136, 143 (1992); oleg artemenko, inspirations from potential: does human embryo in vitro possess full moral status?, 32 (student thesis, linköping university, department of culture and communication, centre for applied ethics, 2010); kate greasley, abortion, feminism, and ‘traditional’ moral philosophy, phil. found.’s med. l. 120, 128 (2019). 10. for a slightly different usage of the term “relational status,” see gloria j. banks, traditional concepts and nontraditional conceptions: social security survivor’s benefits for posthumously conceived children, 32 loy. l.a. l. rev. 251, 338 n.448 (1999); (“other possible means of proving traditional relational status such as legal adoption, equitable adoption, parentage by step-marital relationship, and other legal fictions based upon an alleged parent’s conduct toward the living or inter-utero child during the parent’s life [. . .]”). 260 indiana health law review [vol. 20:257 thus, the moral and legal status of the embryo in such cases should subjectively depend on, and be a derivative of, the individual autonomous parental intentions, articulated in their private agreement according to specified contractual stipulations, thereby, bypassing any determination of whether it is a person, or something in between. indeed, in the recent legal literature, there has been powerful calls for more flexibility in defining frozen embryos.11 considering relational ethics, which will be presented at length in section 2, is a decision-making model that outlines two core principles: mutual respect, and relational engagement.12 a more relational definition of the status of the frozen embryo and the fetus as a byproduct of the existing and impending relationship between them and their progenitors is warranted. the legal and moral status of these embryos should no longer be defined in dichotomous and objective terms, as has been traditionally accepted for decades. instead, their status should be considered subjective and relational, which in the context of relational ethics, primarily depends on their current and future relationships with each contacting party, who have entered into a private agreement reflecting their interest in becoming (or not) the legal parent of the intended child. understanding the conceptual and/or paradigmatic difficulty of dealing with the moral and legal status of both the frozen embryo and the fetus is essential.13 not only have both been discussed in countless books and articles, but even today, they continue to be hotly debated issues. nonetheless, relational ethics offers a new and intriguing perspective for addressing these issues, which frequently are intertwined and treated as one.14 one of the most long-standing and substantive views on this issue is that of the catholic church, which rather than maneuvering along the slippery, and ever-changing slope of trying to identify a 11. see jessica berg, owning persons: the application of property theory to embryos and fetuses, 40 wake forest l. rev. 159, 159 (2005); ibid, elephants and embryos: a proposed framework for legal personhood, 59 hastings l.j. 369, 369 (2007). see also steiger, supra note 5, at 169. (“the first necessary step is to establish a firm legal categorization of embryos and fetuses, based on their stage of development. embryos and pre-viable fetuses must be acknowledged as property [. . .] fetuses that have reached viability must be recognized as full persons and citizens, protected by the state.”). 12. see jean chagnon, relational ethics a framework for ethical practice in rural settings, minn. psych. ass’n, https://www.mnpsych.org/relational-ethics [https://perma.cc/tj7p59ba] (last visited apr. 4, 2023). 13. see wheatley, supra note 7, at 324 (“[w]hile abortion doctrine is a useful analogy, abortion and pre-embryo disposition are not the same thing”). 14. see, e.g., hyun jee son, artificial wombs, frozen embryos, and abortion: reconciling viability’s doctrinal ambiguity, 14 ucla women’s l.j. 213, 213 (2005); alyssa yoshida, the modern legal status of frozen embryos, 68 hastings l.j. 711,711 (2017); madison hynes, “who gets the children?”: innovations in reproductive technology create more problems than solutions for the legal system, 53 uic j. marshall l. rev. 163, 166 (2020) (“[. . .] the potential effect of overturning the monumental case roe v. wade could have on current american laws regarding the disposition of frozen embryos.”). 2023] from (moral) status (of the frozen embryo) 261 point at which human life begins, still holds to the firm view that full personhood begins at conception.15 this article suggests that, instead of focusing on what is a life and when it begins, the future relationships between either the frozen embryo or the fetus and its intending parents must be examined in order to determine its relational moral and legal status. empirical sociological studies have demonstrated that infertility patients consider their frozen embryos as their own child no less than their pregnant counterparts conceptualize their fetus as their child.16 therefore, treating these intertwined, albeit not identical issues in tandem may provide important insights. this article will focus on the moral status of the frozen embryo and will address the moral status of the fetus as either a point of reference or as an additional ramification of the proposed analysis. after the introduction, the article begins the discussion in section 1 by exploring two of the most troubling dilemmas in the field of in-vitro fertilization (ivf) – the difficulty of precisely defining the moral and legal status of both the frozen embryo and the challenges of its contractual regulation. in section 2, relational ethics will explore the possible antecedent – relational autonomy – and examine the correct relationship of these concepts. focusing on the moral and legal status of a fetus, section 3 analyzes the issue from a legal perspective, and section 4 from a philosophical viewpoint, examining the issues of personhood and potentiality. section 5 explores the bioethical and sociological aspects of the issue, discussing biological ethics and relational ethics, while section 6 turns to the perspective of jewish law and the halakhic relational moral status of a frozen embryo. all the preceding interdisciplinary discussion provides the basis for section 7, where the article engages in a normative deliberation, describing the advantages of a disposition agreement in determining the relational moral and legal status of frozen embryos considering the exceptional circumstances of various scenarios.17 15. therefore, surplus frozen embryos must not be destroyed and instead should be adopted by other infertile couples, as is the main theme of the snowflake adoption program. see katheryn d. katz, snowflake adoptions and orphan embryos: the legal implications of embryo donation, 18 wis. women’s l.j. 179, 179 (2003); karin a. moore, embryo adoption: the legal and moral challenges, 1 u. st. thomas j. l. & pub. pol’y 100, 101-19 (2007). 16. see, e.g., yael shalom & yael hashiloni-dolev, fertility patient’s views regarding the moral status and the appropriate use of frozen pre-embros, 3 health l. & bioethics 175, 179 (2010) (heb.); sheryl de lacey, parent identity, and ‘virtual’ children: why patients discard rather than donate unused embryos, 20(6) hum. reprod. 1661, 1661 (2005); abigail maguire, an examination into the embryo disposal practices of human fertilization and embryology authority licensed fertility centers in the united kingdom, 30(1) cambridge q. healthcare ethics 161, 168 (2021). 17. for a close discussion of the interplay of status and contractual regulation in the field of fiduciary, see the following seminal references: beach petroleum v. kennedy (1999) 48 nswlr 1, 188 (“[. . .] status based fiduciary relationship, the duty is not derived from status. as in all such cases, the duty is derived from what the solicitor undertakes [. . .]”); james edelman, when do fiduciary duties arise?, 126 lqr 302, 302 (2010) (“fiduciary duties [. . .] are not duties which 262 indiana health law review [vol. 20:257 1. the relational/relative moral status of the frozen embryo (and the fetus) and its contractual regulation challenges the current surge in ivf usage and its inevitable byproduct – the accumulation of hundreds of thousands of unused frozen embryos – raises a myriad of ethical and legal dilemmas. such as, what should be done with the unneeded frozen embryo if contact with its progenitors has been lost and they are no longer available, either because the couple has moved to another location or simply lost contact with the fertility clinic.18 in such cases, what is to be the fate of the abandoned frozen embryos – should they be discarded, put up for adoption by interested couples,19 or earmarked for research?20 in addition, disagreements may arise between the progenitors regarding the disposition of their frozen embryos during the time they are cryopreserved, which may last for years and even decades.21 is it appropriate to deal with “custody” of frozen embryos?22 do are imposed by law nor are they necessarily referable to a relationship or status. it is time to move from thinking of fiduciary duties as a matter of status to understanding them as based upon consent.”); ibid, the role of status in the law of obligations: common callings, implied terms, and lessons for fiduciary duties, in philosophical foundations of fiduciary law 21, 36 (andrew s. gold & paul b miller, eds., 2014) (“in various areas of the law of obligations [. . .] it was also thought that the obligation was imposed on a person due to that person’s status or office. that view is no longer held. instead, status or office serves as a basis from which an implication can be drawn in an undertaking by the obligor.”). 18. lynne m. thomas, abandoned frozen embryos and texas law of abandoned personal property: should there be a connection, 29 st. mary’s l.j. 255, 260 n.14, 271 n.69 (1997); paul c. ii redman & lauren fielder redman, seeking a better solution for the disposition of frozen embryos: is embryo adoption the answer, 35 tulsa l.j. 583, 596-97 (2000); gerard letterie & dov fox, lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period, 1(2) f&s rep.’s 78, 78 (2020). 19. see jessica l. lambert, developing a legal framework for resolving disputes between adoptive parents of frozen embryos: a comparison to resolutions of divorce disputes between progenitors, 49 b.c. l. rev. 529, 529 (2008); redman & fielder redman, supra note 18; bruce p. blackshaw & nicholas colgrove, frozen embryos and the obligation to adopt, 34(8) bioethics 857, 857 (2020). see infra note 112; see also alex polyakov & genia rozen, social egg freezing and donation: waste not, want not, 47 j. med. ethics, e73 , e73 (2021) (a recent survey conducted in australia found that most women who have frozen their eggs will not be using them, which make them available for adoption. 4048 women have eggs in storage in victoria — an increase of almost 30% since 2019. of those, only 159 women came back to use their eggs in the last year — just 3.9%). 20. see peter j. burton & katherine sanders, patient attitudes to donation of embryos for research in western australia, 180(11) med. j. austl. 559, 559 (2004); catarina samorinha & susana silva, a patient-centred approach to embryo donation for research, 5 isr j. health pol’y res. 44, 44 (2016); catarina samorinha et al., factors associated with the donation and non-donation of embryos for research: a systematic review, 20(5) hum. reprod. update 641, 641 (2014). 21. see, e.g., daniel i. steinberg, note, divergent conceptions: procreational rights and 2023] from (moral) status (of the frozen embryo) 263 they “belong” to any of the progenitors, and if so, to whom exactly – the man who supplies the sperm, the woman who donates the ovum, or both? which right should prevail, the right to procreate or the right to not procreate?23 indeed, there is no lack of contractual challenges and questions in this field. for example, if the couple has previously entered into a disposition agreement, is it a binding contract and should it be enforceable?24 even if there is an explicit agreement, what should happen if there are unforeseeable or changed circumstances, such as the breakdown of the couple’s relationship, the death of one of them, or the loss of legal capacity?25 what if one party has changed their mind during the time from the freezing of the fertilized eggs until the disagreements emerge?26 a controversy exists in the legal literature over whether the contractual regulation of the fate of frozen embryos offers more advantages27 or disadvantages for the contracting parties.28 one of the most substantial dilemmas disputes over the fate of frozen embryos, 7 b.u. pub. int. l.j. 315, 315 (1998); jennifer m. stolier, disputing frozen embryos: using international perspectives to formulate uniform u.s. policy, 9 tul. j. int’l & comp. l. 459, 459 (2001); shelly r. petralia, note, resolving disputes over excess frozen embryos through the confines of property and contract law, 17 j. l. & health 103, 103 (2002). 22. see paula walter, his, hers, or theirs custody, control, and contracts: allocating decisional authority over frozen embryos, 29 seton hall l. rev. 937, 937 (1999); peter e. malo, deciding custody of frozen embryos: many eggs are frozen but who is chosen?, 3 depaul j. health care l. 307, 307 (2000); mary joy dingler, family law’s coldest war: the battle for frozen embryos and the need for a statutory white flag, 43 seattle u. l. rev. 293, 293 (2019). 23. see, e.g., mark c. haut, note, divorce and the disposition of frozen embryos, 28 hofstra l. rev. 493, 510-16 (1999); i. glenn cohen, the right not to be a genetic parent?, 81 s. cal. l. rev. 1115, 1115 (2008); ibid, the constitution and the rights not to procreate, 60 stan. l. rev. 1135, 1135 (2008). 24. see john a. robertson, prior agreements for disposition of frozen embryos, 51 ohio st. l.j. 407, 407 (1990); john a. robertson, precommitment strategies for disposition of frozen embryos, 50 emory l.j. 989, 989 (2001); lambert, supra note 19, at 542-45, 558-63. 25. see haut, supra note 23, at 519-22; jennifer m. dehmel, to have or not to have: whose procreative rights prevail in disputes over dispositions of frozen embryos, 27 conn. l. rev. 1377, 1400, 1405 (1995); carl h. coleman, procreative liberty and contemporaneous choice: an inalienable rights approach to frozen embryo disputes, 84 minn. l. rev. 55, 73-74, 99, 114 (1999). 26. see coleman, supra note 25, at 90-95, 110-11; robertson, supra note 24, at 414, 419-20, 424; helene s. shapo, frozen pre-embryos and the right to change one’s mind, 12 duke j. comp. & int’l l. 75, 75 (2002). 27. see, e.g., mario j. trespalacios, frozen embryos: towards an equitable solution, 46 u. miami l. rev. 803, 803 (1992); melanie m. lupsa, comment, avoiding forced parenthood: a practical legal framework to resolve disputes involving the disposition of embryos, 49 seton hall l. rev. 951, 951 (2019); robertson, supra note 24. 28. see lambert, supra note 19; donna m. sheinbach, examining disputes over ownership 264 indiana health law review [vol. 20:257 is the moral and legal status of frozen embryos. if one conceptualizes them as property the progenitors possess, such private regulation is logically appropriate; and in contrast, if the frozen embryos are treated as human beings, such property discourse and ownership are a priori irrelevant.29 this controversy involves three major views of the issue, all of which are arisen in legal academia and different jurisdictions in the united states. the first is a view of the frozen embryo as a human being for all intents and purposes, which has been explicitly recognized in louisiana30 and new mexico statutes.31 the second considers the frozen embryo as a mere commodity belonging to the progenitor.32 the third viewpoint, the frozen embryo is neither a person nor a property but falls into an “interim category” that entitles it to “special respect.”33 these three distinct categories have also been applied in most of the cases, albeit mostly implicitly by the courts for almost three decades. most cases have treated the frozen embryo as property, explicitly or implicitly to varying degrees,34 three of them have treated it as an intermediate category of special rights to frozen embryos: will prior consent documents survive if challenged by state law and/or constitutional principles?, 48 cath. u. l. rev. 989, 989 (1999); stacie l. provencher, family law—states should create a heightened standard of review for contracts that determine the disposition of frozen embryos in contested divorce cases, 42 w. new eng. l. rev. 295, 295 (2020). 29. for the close connection between the moral status and the appropriateness of the contractual usage, see davidoff, supra note 6, at 159. (“for instance, where a court adopts the embryo-as-life theory, it may specifically negate the parties’ intent to discard in vitro embryos upon the occurrence of a specified event.”); petralia, supra note 21, at 103. (“the dominion of property law suggests that the enforcement of contracts is eminent to communal survival.”); harman, supra note 2, at 529 (“[. . .] under the property theory, in which the embryos are the property of the progenitors and are subject to their control. as such, the embryos can be the subject of a contract.”). 30. la. rev. stat. §§ 9:121-33 (1999); see also berg, elephants, supra note 11, at 369, 392; berg, owning, supra note 11, at 161; thomas, supra note 18, at 286-87. for a discussion of this state’s stringent approach towards abortion, see yehezkel margalit & pnina lifshitz-aviram, towards a new archimedean point of maternal vs. fetal rights?, 81 la. l. rev. 447, 447 (2021). 31. n.m. stat. § 24-9a-1(d) (2006) (discussed by harman, supra note 2, at 526-28); shirley darby howell, the frozen embryo: scholarly theories, case law, and proposed state regulation, 14 depaul j. health care l. 407, 412-14 (2013). 32. see berg, owning, supra note 11; tracy j. frazier, of property and procreation: oregon’s place in the national debate over frozen embryo disputes, 88 or. l. rev. 931, 931 (2009); herrera, supra note 7, at 125-28. 33. see thomas, supra note 18, at 288-95; harman, supra note 2, at 535-41; provencher, supra note 28, at 298. 34. see york v. jones, 717 f. supp. 421, 425-27 (e.d.va. 1989); kass v. kass, 235 a.d.2d 150, 150 (n.y. app. div. 1997), aff’d 696 n.e.2d 174 (1998); litowitz v. litowitz, 102 wash. app. 934, 934 (wash. app. div.2 2000); in re marriage of witten, 672 n.w.2d 768, 768 (iowa 2003); roman v. roman, 193 s.w.3d 40, 40 (tex. app.-houston 1st dist., 2006); in re marriage of dahl & angle, 194 p.3d 834, 834 (or. ct. app. 2008); reber v. reiss, 2012 pa super 86, 42 a.3d 1131 (balancing-of-interests test); in re marriage of rooks, no. 16sc906, 2017 colo. lexis 2023] from (moral) status (of the frozen embryo) 265 character or deserving of special respect,35 and only one case, davis v. davis, has treated it as a person.36 but recently, one can find in the legal writing several interesting attempts to challenge this dichotomy.37 for example, in two companion articles, jessica berg has advocated the following novel approach: it argues that “person” and “property” are not mutually exclusive designations, and one might recognize both property interests in, and personhood interests of, certain entities. depending on the outcome of the personhood analysis, either property interests will be controlled, or the property interests will be balanced against the personhood interests.38 since personhood and property are mutually exclusive categories, she argues, what we get is a zero-sum game, which is not in any way appropriate in this situation. according to berg, instead of this misleading traditional conceptualization, one should use a framework of combined property and personhood approaches. property law may provide a more appropriate framework under which to analyze embryos, but as the embryo develops, personal interests prevail over property interests. hence, one can argue that property analysis applies to both fetuses and frozen embryos, and this paradigm is much better than the prevailing legal rights discourse in resolving disagreements in this sensitive field.39 286, [286] (apr. 17, 2017) (balancing-interests test). 35. see davis v. davis, 842 s.w.2d 588, [588] (tenn., 1992); jeter v. mayo clinic arizona, 211 ariz. 386, 406 (ariz. ct. app. 2005) (“given the interim status of pre-embryos and the special respect they should be accorded in certain situations [. . .].”); mcqueen v. gadberry, 507 s.w.3d 127, 132 (mo. ct. app. 2016) (“[. . .] frozen pre-embryos are marital property of a special character [. . .]”); terrell v. torres, supra note 7 (“interim category that entitles them to special respect because of their potential for human life.”). 36. see davis, supra note 33, at 593. see also a.z. v. b.z., 431 mass. 150, 150 (mass. 2000); j.b. v. m.b, 783 a.2d 707, 707 (n.j. 2001); szafranski v. dunston, 34 n.e.3d 1132, 1132 (ill. app. ct. 2015). therefore, the author disagrees with the claim that “overall, most courts treat embryos as a special category of property—one that is not truly property,” provencher, supra note 28, at 298. 37. see kathleen r. guzman, property, progeny, body part: assisted reproduction and the transfer of wealth, 31 u.c. davis l. rev. 193, 208-11 (1997). see also robert j. muller, davis v. davis: the applicability of privacy and property rights to the disposition of frozen preembryos in intrafamilial disputes, 24 u. tol. l. rev. 763, 791-803 (1993); jens d. ohlin, is the concept of the person necessary for human rights, 105 colum. l. rev. 209, 211 (2005); see margaret j. radin, property and personhood, 34 stan. l. rev. 957, 986-88 (1982). 38. owning persons, supra note 11, at 162, 184. (“placing something on the continuum is, to a certain extent, subjective, and individuals may even conceive of something as personal in one context and fungible in another.”); see also berg, owning, supra note 11, at 369, 392. 39. berg, owning, supra note 11, at 211-12, 217-19; see alan gewirth, human rights: essays on justification and applications 94 ethics 324-325 (1982); jeremy waldron, theories of rights (oxford univ. press 1985); ronald dworkin, taking rights seriously (bloomburg 2013); jack donnelly, universal human rights in theory and practice (cornell univ. 266 indiana health law review [vol. 20:257 in her companion article, berg differentiated between a juridical person40 and a natural person.41 since one can find no express definition of “person” in either the u.s. constitution or in supreme court rulings, every jurisdiction defines it differently, depending on its specific goal. as berg argues, “it could be that there are simply a number of different areas of law that define persons in diverse ways depending on the purpose of the law, but no cohesive ‘law of persons.’”42 furthermore, the term juridical person may be accorded different legal rights and protections. since fetuses are considered as such in many states, they have specific, but not complete, rights: as a result, we may choose to provide personhood protections for sentient fetuses without granting them the same rights as fully recognized natural persons. juridical personhood is not a unitary concept; there are various kinds of juridical persons and different rights which may adhere. to the extent that states have discretion in determining which entities will be considered juridical persons, they may make different choices about the types of rights which they grant sentient fetuses.43 similarly, jonathan herring has developed the concept of relational personhood. his interesting and challenging contention is that in determining the moral status of the fetus and/or frozen embryo, one should not consider conventional abilities or characteristics, but should focus on mutual relationships with others, especially caring relations, since our vulnerability and interdependency profoundly influence our humanity and define our moral status. herring states: one should consider the value of relationships. all caring relationships are of moral value and therefore there is no valuing of persons per se: it press 2013). 40. see leonard w. sumner, abortion and moral theory 57 (princeton univ. press 1981); kristin luker, abortion and the politics of motherhood 3 ( uc press 1985); britta van beers, the changing nature of law’s natural person: the impact of emerging technologies on the legal concept of the person, 18 german l.j. 559, 565, 585 (2017). 41. berg, supra note 11, at 393 (“if this is the case, then the lack of legal personhood recognition will not negate the moral claims of the entity in question. the entity may still have certain moral rights, and others will have moral obligations to respect those rights.”). for further academic discussion of the juridical person in the abortion context, see jenny teichman, the definition of person, 60(232) phil. 175, 177-82 (1985); jonathan f. will, beyond abortion: why the personhood movement implicates reproductive choice, 39(4) am. j. l. & med. 573, 603 n.249 (2013); ligia m. de jesus, the inter-american court on human rights’ judgment in artavia murillo v. costa rica, and its implications for the creation of abortion rights in the interamerican system of human rights, 16 or. rev. int’l l. 225, 243 (2014). 42. berg, supra note 11, at 371. for a further discussion of these natural/juridical persons, see margalit & lifshitz-aviram, infra note 73, passim. 43. berg, supra note 11, at 400. see also the discussion of fetuses and embryos, ibid, at 388402. 2023] from (moral) status (of the frozen embryo) 267 is relationships which generate value [. . .] our greatest claim to moral value lies not in ourselves, but in relationships of care. am i a person? by myself, no. are we people? yes, if we care. together we are so much more than when we are alone.44 in herring’s most recent article, he elaborates that the relational approach teaches us that the moral value of personhood is not found in any individual characteristics, but in one’s relationships with others. [relational personhood] since individuals define themselves through their relations, these interconnections should constitute their identities through the legal recognition of these social interactions. this is one of the reasons why the breakdown of marriages are treated as one of the saddest and most difficult events to overcome. as herring writes: it flows from the fact that people are in their very nature vulnerable, caring and relational that the basic moral value of being human is not found in a person’s individual capabilities nor in their membership of the species, but rather in their relationships [. . .] it is their relationships, rather than any inherent characteristics, which have moral value and are deserving of especial moral status.45 2. relational ethics and relational autonomy relational ethics is a variant of the broader subject of the ethics of care. both hold that moral action should be centered on interpersonal relationships and care or benevolence. carol gilligan, considered the founder of the field of the ethics of care, emphasizes the importance of responding to the individual, since persons should be understood as being dependent and interdependent on others to varying degrees.46 gilligan argues that men and women tend to conceptualize morality 44. charles foster & jonathan herring, identify, personhood and the law 35 (springer cham 2017). for the importance of the relational aspect to the definition of personhood, see harriet a. harris, should we say that personhood is relational?, 51(2) scott j. theol. 214, 214 (1998); kenneth j. gergen, relational being: beyond self and community (2009); jennifer nedelsky, law’s relations: a relational theory of self, autonomy, and law (2011). 45. jonathan herring, relational personhood, 1 keele l.j. 24, 24 (2020). for additional articles regarding relational personhood, see annette baier, cartesian persons, in postures of the mind: essays on mind and morals 74, 74 (annette baier ed., 1985); brenda appleby & nuala p. kenny, relational personhood, social justice and the common good: catholic contributions toward a public health ethics, 16(3) christian bioethics: non-ecumenical studies in med. morality 296, 296 (2010); chris fowler, relational personhood revisited, 26(3) cambridge archaeological j. 397, 397 (2016). 46. see carol gilligan, in a different voice: psychological theory and women’s development (harv. univ. press 2016) ; see also making connections: the relational worlds of adolescent girls at emma willard school (carol gilligan et al. eds., 1990); carol 268 indiana health law review [vol. 20:257 differently, where women tend to emphasize empathy and compassion rather than the notion of morality. one of the prominent originators of relational ethics is nel noddings, who, like many other feminists,47 acknowledges human relationships, women’s life experiences, and how both influence one’s decision-making. noddings claims that instead of trying to provide a systematic examination of the requirements for caring, one should support the three pillars of care–engrossment, motivational displacement, and the responsiveness of the person receiving care to that care. some scholars claimed that this concept is derivative of the more general notion of relational autonomy.48 as opposed to individualistic autonomy,49 relational autonomy maintains that individuals are a part of a social network that assists them in executing their plans. autonomy should also reflect the social and cultural backgrounds of a given person, as well as, ones’ close relationships, and the support those relationships provide.50 consequently, one should conceptualize autonomy while taking into consideration that social background and environment influence a person’s decision-making capability. since individuals are influenced by their social environment, and without it, would find it difficult to fulfill oneself, this social influence should be accorded significant importance, especially in cases where individual actions will, in turn, affect these social forces.51 it is beyond the scope of this article to extensively elaborate on whether gilligan, moral orientation and moral development, the feminist phil. reader 467, 467 (2008). for the consequent variants of gilligan’s work, including noddings’s work, see feminist ethics, stan. encyclopedia of phil. (may 27, 2019), https://plato.stanford.edu/ entries/feminism-ethics/ [https://perma.cc/9gng-p9dd]. 47. see carole pateman, the sexual contract (stanford university press 1988); martha albertson fineman, the autonomy myth: a theory of dependency (the new press 2004). 48. see, e.g., relational autonomy: feminist perspectives on autonomy, agency, and the social self (oxford univ. press 2000); john christman, relational autonomy, liberal individualism, and the social constitution of selves, 117 phil. stud.’s: an int’l j. phil. in the analytic tradition 143, 143 (2004); andrea c. westlund, rethinking relational autonomy, 24(4) hypatia 26, 26 (2009). 49. the academic literature regarding this autonomy and its critique is enormous, below are landmark researches: isaiah berlin, four essays on liberty 131 (oxford univ. press 1969); marilyn friedman, autonomy, gender, politics (oxford univ. press 2003); john christman, autonomy in moral and political philosophy, stan. encyclopedia phil. (june 29, 2020), https://plato.stanford.edu/entries/autonomy-moral/ [https://perma.cc/de6j-ef6v]. 50. see daniel bell, communitarianism, and its critics (clarendon press 1993); mark kuczewski & patrick j. mccruden, informed consent: does it take a village? the problem of culture and truth telling, 10 cambridge q. healthcare ethics 34, 34 (2001). 51. see, e.g., jennifer nedelsky, reconceiving autonomy: sources, thoughts and possibilities, 1 yale j. l. & feminism 7, 7 (1989); charles taylor, the ethics of authenticity (harv. univ. press 1992); relational autonomy: feminist perspectives on autonomy, agency, and the social self 236 (oxford univ. press 2000). 2023] from (moral) status (of the frozen embryo) 269 relational ethics is indeed a branch of relational autonomy or what precisely the relationship between the two notions.52 in brief, both relational autonomy and ethics maintain that the person is not fundamentally isolated but is a relational and caring interdependent being. everyone is profoundly affected by social and familial relationships, which provide the basis for developing individuality and particularity. to be a person is to be in relationships; therefore, people are interdependent individuals and are not self-sufficient. in contrast, the fields of individualistic autonomy and ethics hold that the individual is devoid of any personal relationships, and relationships among friends and family. abstract individuality is freed from any social and familial ties and specificities; thus, the autonomous person should be understood as a self-sufficient, independent individual, resulting in an individualistic autonomy.53 it is worth emphasizing that relational autonomy, like relational ethics, is gaining more influence in legal and ethical literature, specifically regarding medical law54 and bioethics.55 according to relational ethics, we should summarily reject the traditional ethical theory that conceptualizes the ethical individual as a rational and autonomous moral agent, who can independently judge the conflicting claims of others. this coherent and monolithic theoretical construct negates differences. instead, noddings argues for a more relational ontology, where the ethical self is a byproduct of relationships of caring with others. she emphasizes interdependence and the importance of maintaining relationships, especially between familial members and friends.56 as nodding 52. see, e.g., the following statements: “i too have argued for a relational ontology and even for relational autonomy,” nel noddings, caring: a relational approach to ethics and moral education 206 (2d ed. 2013); nel noddings, the maternal factor: two paths to morality 111-12, 198, 242 (univ. of ca. 2010). 53. see marilyn friedman, autonomy, social disruption and women, relational autonomy: feminist perspectives on autonomy, agency, and the social self 35, 40-41 (2000); virginia held, the ethics of care: personal, political, and global 46 (oxford univ. press 2006); peter ikechukwu osuji, relational autonomy in informed consent (raic) as an ethics of care approach to the concept of informed consent, 21(6) med. health care & phil. 101, 107-08 (2018). 54. see carolyn mcleod & susan sherwin, relational autonomy, self trust and health care for patients who are oppressed, in relational autonomy: feminist perspectives on autonomy, agency, and the social self 259, 259 (2000); anita ho, relational autonomy or undue pressure? family’s role in medical decision making, 22 scandinavian j. caring sci. 128, 128 (2008); roy gilbar, family involvement, independence, and patient autonomy in practice, 19(2) med. l. rev. 192, 192 (2011). 55. see anne donchin, autonomy and interdependence: quandaries in genetic decisionmaking, in relational autonomy: feminist perspectives on autonomy, agency, and the social self 236, 236 (2000); leigh turner, bioethics in a multicultural world: medicine and morality in pluralistic settings, 11 healthcare analysis 99, 99 (2003); james lindemann nelson & hilde lindemann nelson, the patient in the family: an ethics of medicine and families 114-17 (routledge 2014). 56. grace clement, care, autonomy, and justice: feminism and the ethic of care 270 indiana health law review [vol. 20:257 states: a relational ethic is rooted in and dependent on natural caring. instead of striving away from affection and towards behaving always out of duty as kant has prescribed, one acting from a perspective of caring moves consciously in the other direction; that is, he or she calls on a sense of obligation in order to stimulate natural caring [ . . . ] because natural caring is both the source and the terminus of ethical caring, it is reasonable to use the mother-child relation as its prototype [ . . . ] caring as a rational moral orientation and maternal thinking with its threefold interests are richly applicable to teaching.57 whereas in her earlier writing during the 1980s, noddings defined herself as writing through the prism of “feminine,” and later research has been written from the relational ethics perspective.58 nodding explained in the preface to the second edition published in 2013 of her original 1984 book, caring: hardly anyone has reacted positively to the word feminine here. in using it, i wanted to acknowledge the roots of caring in women’s experience, but [. . .] relational is a better word. virtually all care theorists make the relation more fundamental than the individual [. . .] persons as individuals are formed in relation. i do not, however, want to lose the centrality of women’s experience in care ethics [. . .].59 such a shift from the “feminine” to the relational perspective eventually yields the more specific variant of the “relational ethics of care,” which was defined by noddings as follows: it is feminine in the deep classical sense-rooted in receptivity, relatedness, and responsiveness. it does not imply either that logic is to be discarded or that logic is alien to women. it represents an alternative to present views, one that begins with the moral attitude or longing for 2 (routledge 1996); nirmala erevelles, the “other” side of the dialectic: toward a materialist ethic of care, disability and difference in global contexts: enabling a transformative body politic 173, 175-77 (2011); and more generally lawrence j. walker, sex differences in moral reasoning, 2 handbook moral behavior & dev. 333, 333 (2014). 57. nel noddings, an ethic of caring and its implications for instructional arrangements, 96(2) am. j. of educ. 215, 219-20 (1988); madeleine arnot & jo-anne dillabough, feminist politics and democratic values in education, 29(2) curriculum inquiry 159, 172 (1999); madeleine arnot , educating the gendered citizen sociological engagements with national and global agendas 40-41 (routledge 2009). 58. compare nel noddings, caring: a feminine approach to ethics and moral education (berkeley: univ. of ca. press 1984); with noddings, supra note 52. 59. noddings, supra note 52. see also nel noddings, a response, 5(1) hypatia: j. feminist phil. 120, 120 (1990). for the centrality of her research, see sarah l. hoagland, review: some concerns about nel noddings’ ‘caring,’ 5(1) hypatia 109, 109 (1990); rosemarie tong, nel noddings’s relational ethics, feminine and feminist ethics 108, 1108 (1993). 2023] from (moral) status (of the frozen embryo) 271 goodness and not with moral reasoning.60 the principles of relational ethics of care emphasize the role of connection, feeling and responding to the vulnerability or dependency of others. people relate with one another in their various roles and commitments; therefore, the principles of relational ethics embrace values such as connectedness, cooperation, and mutual support. this unique mixture of relational ethics and the ethics of care have been implemented in a variety of fields, such as nursing,61 autoethnography,62 theology, and religious studies,63 social work, cultural geography, social policy, infrastructural repair, narrative inquiry, intellectual disability, education, emergent creativity,64 and more. the possible 60. noddings, supra note 52, at 2. for this branch of the ethics of care, see the following seminal articles: helga kuhse, against the stream: why nurses should say “no” to a female ethics of care, 49(193) revue int'l's de phil. 285, 301 (1995); fiona robinson, globalizing care: ethics, feminist theory, and international relations, 22(1) alt.'s: global, local, pol. 113, 118, 130 (1997); carolyn ellis, interviewing and storytelling from a relational ethics of care, the routledge int'l handbook on narrative & life hist. 431, 431 (2016). 61. see sara t. fry, the role of caring in a theory of nursing ethics, 4(2) hypatia 87, 9398 (1989); randy spreen parker, nurses’ stories: the search for a relational ethics of care, 13(1) advances in nursing sci. 31, 31 (1990); john duffy , provocations of virtue: rhetoric, ethics, and the teaching of writing (univ. press of co. 2019); per nortvedt et al., the ethics of care: role obligations and moderate partiality in health care, 18(2) nursing ethics 192, 192 (2011). 62. carolyn ellis, manifesting compassionate autoethnographic research: focusing on others, 10(1) int’l rev. of qualitative res. 54, 54 (2017); arthur p. bochner, heart of the matter: a mini-manifesto for autoethnography, 10(1) int’l rev. of qualitative res. 67, 77 (2017). 63. karl e. peters et al., reflections of a naturalistic-evolutionary-practical theologian in conversation with gallagher and pangerl, 26(3) am. j. theology & phil. 224, 234 (2005); anna f. bialek, vulnerability and its power: recognition, response, and the problem of valorization 28 (unpublished dissertation, brown univ. 2016). 64. see mel gray, moral sources and emergent ethical theories in social work, 40(6) the british j. social work 1794, 1806 (2010); sarah wright et al., working with and learning from country: decentring human authority, 22(2) cultural geographies 269, 270 (2015); gerry mooney, book review: wilt atkinson, steven roberts and mike savage (eds.), class inequality in austerity britain: power, difference and suffering, basingstoke: palgrave macmillan, 33 critical soc. pol’y 575, 584 (2013); vera caine et al., the necessity of a relational ethics alongside noddings’ ethics of care in narrative inquiry, 20(3) qualitative res. 265, 265 (2020); charlotte capri & leslie swartz, the right to be freepeople: relational voluntary-assisted-advocacy as a psychological and ethical resource for decolonizing intellectual disability, 6(2) j. social & pol. psych. 556, 556 (2018); orit schwarz-franco, touching the challenge: embodied solutions enabling humanistic moral education, 45(4) j. of moral educ. 449, 449 (2016); janneke adema, the ethics of emergent creativity: can we move beyond writing as human enterprise, commodity and innovation? , whose book is it anyway? a view from elsewhere on publishing, copyright and creativity 65, 75 (2019). 272 indiana health law review [vol. 20:257 implementation of the relational ethics of care in the context of abortion, while focusing on the various rights and obligations relating to the relationship itself, and not the individuals involved in these relations, will be discussed in the next section. to the author’s knowledge, no legal articles have dealt with either the precursors to relational ethics, or this more specific branch of ethics in the context of the moral and legal status of the frozen embryo. the following theoretical and practical discussion in this article should help fill this lacuna. 3. the law’s perspective – the moral and legal status of an un/desired fetus the relational approach, as a branch of the ethics of care, has been applied in the context of abortion.65 on its face, in the legal scholarly literature, this branch of ethics, with its emphasis on care and responsibility for others, does not support the legitimacy of abortion. rather, the relational approach focuses on interconnectedness and the importance of preserving current and future relationships with the fetus, regardless of its moral status. thus, pro-life advocates focus on dependency of the fetus and the caring desire to assist it in fulfilling its most basic human interest to be born,66 and therefore, campaign endlessly to outlaw abortion at any cost.67 as jonathan herring observed: it must be admitted that, at first sight, it might be thought that ethics of care would be opposed to abortion, and indeed, this is a line some ethics of care writers have taken.68 however, in two companion articles, herring recently claimed the opposite, asserting that there are reasonable justifications for this branch of ethics endorsing 65. see diana fritz cates, caring for girls and women who are considering abortion: rethinking informed consent, med. & the ethics of care 162, 162 (2001); michael slot, the ethics of care and empathy 16 (routledge 2007); tove pettersen , comprehending care: problems and possibilities in the ethics of care 12, 19, 144 (lexington books 2008). 66. see robert f. drinan, the inviolability of the right to be born, 17 w. res. l. rev. 465, 465 (1965); george schedler, women’s reproductive rights: is there a conflict with a child’s right to be born free from defects?, 7(3) j. of legal med. 356, 356 (1986); shiva m. singh et al., fetal alcohol and the right to be born healthy. . . , 5 frontiers in genetics 356, 356 (2014). 67. see, e.g., pamela s. katlan & daniel r. ortiz, in a diffident voice: relational feminism abortion rights, and the feminist legal agenda, 87 nw. u. l. rev. 858, 858 (1993). for the prolife movement, see carol mason, killing for life: the apocalyptic narrative of prolife politics, (cornell univ. press 2002) ; ziad w. munson, the making of pro-life activists: how social movement mobilization works, (univ. of chi. press 2010); joona räsänen, why pro-life arguments still are not convincing: a reply to my critics, 32 bioethics 628, 628 (2018). 68. jonathan herring, the termination of pregnancy and the criminal law, homicide in crim. l.: a research companion 136, 145 (2018). see also held, supra note 53, at 1; jonathan herring, caring, 159 l. & just. christian l. rev. 89, 100 (2007). for a supplemental recent discussion of the responsibility angle regarding the abortion, see margalit & lifshitz-aviram, supra note 31, passim, and more extensively at margalit & lifshitz-aviram, infra note 73. 2023] from (moral) status (of the frozen embryo) 273 the right to abort in any case of unplanned or undesired pregnancy.69 this is not an original argument of his, as some prominent writers, such as celia wolfedevine, have made this claim in the past.70 arguably, however, herring adds an important layer to the discussion in elaborating that abortion should be conceptualized as no less than a “public good.”71 herring also claims that the ethics of care is a more convincing reason to support abortion than the prevailing longstanding justifications of the right to choose, the basic human right which underpins the pro-choice movement,72 and drawing on the argued right to bodily integrity.73 herring ‘s argument rests mainly on abandoning the human rights discourse, which is the dominant one today,74 and which considers the gestational mother and the fetus as rivals. instead, we should treat pregnancy as the ultimate intertwined relationship composed of both biological and psychological 69. see herring, the termination, ibid; compare jonathan herring, ethics of care and the public good of abortion, 2 u. oxford hum. rights hub j. 1, 8 (2019) (“but wolf-devine is correct that such powerful justifications for abortion rights, sit a little uncomfortably with the language of care and relationality promoted by ethics of care.”); with eugenie gatens-robinson, a defense of women’s choice: abortion and the ethics of care, 30(3) s. j. phil. 39, 39 (1992). 70. celia wolfe-devine, abortion and the “feminine voice”, 3(3) pub. aff.'s q. 81, 81 (1989). see also robin west, liberalism and abortion, 87 geo. l.j. 2117, 2117 (1999); eileen mcdonagh, breaking the abortion deadlock: from choice to consent (oxford univ. press 1996). 71. herring, supra note 69, passim. see also karen s. conway & michael r. butler, state abortion legislation as a public good—before and after roe v. wade, 30(4) econ. inquiry 609, 609 (1992); karyn g. gordon, securing the public good and private rights: state constitutional free speech guarantees and anti-abortion protest activity on privately-owned clinic property, 23 rutgers l.j. 1053, 1053 (1992). for the close contention that abortion is a moral good, see katie watson, the art of medicine abortion as a moral good, 393 the lancet 1196, 1196 (2019). 72. see suzanne staggenborg, coalition work in the pro-choice movement: organizational and environmental opportunities and obstacles, 33 soc. problems 374, 374 (1986); suzanne staggenborg, the consequences of professionalization and formalization in the pro-choice movement, 53 am. socio. rev. 585, 585 (1988); suzanne staggenborg, the pro-choice movement: organization and activism in the abortion conflict (oxford univ. press 1991). 73. for an academic discussion of this substantial claim for endorsing abortion, see christyne, l. neff, women, womb, and bodily integrity, 3 yale j. l. & feminism 327, 327 (19901991); ruth a. miller , the limits of bodily integrity: abortion, adultery, and rape legislation in comparative perspective (routledge 2007). 74. for the dominancy of this discourse also in the context of abortion, see rebecca j. cook & bernard m. dickens, human rights dynamics of abortion law reform , 25 hum. rights quarterly 1, 1 (2003); christina zampas & jaime m. gher, abortion as a human right—international and regional standards, 8(2) hum. rights l. rev. 249, 249 (2008); johanna b. fine et al., the role of international human rights norms in the liberalization of abortion laws globally, 19(1) health & hum. rights 69, 69 (2017). 274 indiana health law review [vol. 20:257 interconnections.75 more specifically, herring enlisted the variant of the “relational ethics of care,” discussed above at the end of section 2, to support his contention that one should not focus on the reciprocal rights and obligations of the fetus in consideration of its specific moral status. rather, it is preferable to inquire what rights, obligations, and responsibilities are owed with respect to this interconnected relationship. consequently, the rights and obligations of the parties involved in the abortion should not be a clear-cut byproduct of the “absolute” status of the fetus, instead, it should be more relational and subjective. regardless, where the pregnancy is intentional and desired, this relationship should be recognized and grant it consequent rights and obligations. in contrast, when pregnancy is undesired and unintentional, the moral and legal status of the relationship is meaningless and should not have rights and obligations stemming from it. as herring concluded in a companion article: the relational approach offers a solution for these concerns. through her care and love for the fetus in a wanted relationship it accepts this relationship is deserving of especial moral status. however, where the relationship is unwanted, it has a different moral status, and the legal response can be completely different.76 considering the foregoing discussion, the author suggests justification for the following rhetorical question by i. glenn cohen, which is the title of one of his articles – “are all abortions equal?” my basic argument is that relational ethics may support the uncontested agreement regarding the exceptions to the criminalization of abortion for rape and incest, anchored in several u.s. jurisdictions, as well as in the hyde amendment, which prohibits the use of federal funding for abortion.77 in his article, cohen reevaluated the prevailing 75. see jonathan herring, the loneliness of status: the legal and moral significance of birth, in birth rights and rites 97 (fatemeh ebtehaj et al. eds., 2011); jonathan herring, caring and the law (bloomsbury pub. 2013); sarudzayi matambanadzo, reconstructing pregnancy, 69 smu l. rev. 187, 187 (2016). 76. herring, the termination, supra note 68, at 148. see also herring, ethics of care, supra note 69, at 1-2 (“the promotion of caring relationships requires both the support and sustenance of care; but also the termination of relationships which are not nurturing or marked by care. this is especially important if people are hindered by non-caring relationships from entering caring ones.”). 77. see i. glenn cohen, are all abortions equal? should there be exceptions to the criminalization of abortion for rape and incest?, 43(1) j. l. 87, 87 n.4-5 (2015); see heather boonstra & adam sonfield, rights without access: revisiting public funding of abortion for poor women, the guttmacher inst. 8 (2000), https://www.guttmacher.org/gpr/2000/04/rightswithout-access-revisiting-public-funding-abortion-poor-women [https://perma.cc/hem5-5qgx] (discussing hyde amendment and the rape and incest exceptions.); stanley k. henshaw et al., restrictions on medicaid funding for abortions: a literature review, the guttmacher inst. (2009), https://www.guttmacher.org/report/restrictions-medicaid-funding-abortions-literaturereview [https://perma.cc/ez8w-qwkk]; brooke mcgee, pregnancy as punishment for lowincome sexual assault victims: an analysis of south dakota’s denial of medicaid-funded abortion for rape and incest victims and why the hyde amendment must be repealed, 27 geo. 2023] from (moral) status (of the frozen embryo) 275 wide consensus concerning the decriminalization of aborting a fetus resulting from a coerced sexual relationship.78 cohen logically asks what the difference between decriminalization of abortion in cases of coerced sexual relationships is, as opposed to criminalization in all other cases. if the moral status of the fetus is akin to that of a person, then all abortions should be prohibited, to respect the most basic human right to be born, its inviolability;79 but if the fetus does not enjoy full personhood, are not all abortions equally permitted? after refuting each of the prevailing justifications for this dichotomy – gestation plus trauma and gestation plus self-defense – cohen suggests the following: a final argument to save the rape and incest exceptions, and in general the one i find the most persuasive, flips the argument on its head in a hohfeldian way: instead of discussing under what circumstances women have (rape and incest) or do not have (all other cases) a right to abort, we ask under what circumstances they owe a duty to the fetus to gestate it and suggest that no duty is owed uniquely in the circumstances of rape and incest.80 moreover, the author suggests the replacement (or supplement) of the human rights discourse in the abortion discussion with the obligations,81 commitments,82 mason u.c.r. l.j. 77, 77 (2016). 78. one of the most prominent scholars in the abortion field differentiated several decades ago between the abortion of a pregnancy resulting from rape, where it is permissible, from all other abortions. see judith. j. thomson, a defense of abortion,1 phil. & pub. aff.’s 47, 49 (1971). for the rape and incest exceptions, see, for example, michele goodwin, the pregnancy penalty, 26 health matrix 17 (2016); caitlin e. borgmann, the meaning of life: belief and reason in the abortion debate, 18 colum. j. gender & l. 551 (2009) , passim; caitlin e. borgmann, roe v. wade’s 40th anniversary: a moment of truth for the anti-abortion-rights movement, 24 stan. l. & pol’y rev. 245, 247, 260 (2013). 79. for this latter notion, which may be interpreted as a right not to perish, but for a good reason, see linda c. mcclain, inviolability and privacy: the castle, the sanctuary, and the body, 7 yale j. l. & hum. 195, 195 (1995); richard stith, on death and dworkin: a critique of his theory of inviolability, 56 md. l. rev. 289, 289 (1997); raanan gillon, is there a ‘new ethics of abortion’? , 27 j. of med. ethics ii5, ii5 (2001). 80. cohen, supra note 77, at 96; see wesley newcomb hohfeld, some fundamental legal conceptions as applied in judicial reasoning, 23 yale l.j. 16, 16 (1913-1914) (discussing the “hohfeldian way”). for the extent to which this genuine conception of rights has massively influenced legal thinking, see max radin, a restatement, of hohfeld, 51 harv. l. rev. 1141, 1141 (1938); joseph w. singer, the legal rights debate in analytical jurisprudence from bentham to hohfeld, 1982 wis. l. rev. 975, 975 (1982); pierre schlag, how to do things with hohfeld, 78 law & contemp. probs. 185, 185 (2015). 81. see diane jeske, families, friends, and special obligations, 28 can. j. phil. 527, 527 (1998); the law of obligations: connections and boundaries (andrew robertson ed., 2004); sarah clark miller, need, care and obligation, 57 royal inst. of phil. supp. 137, 137 (2005). 82. see, e.g., barbara d. whitehead, the divorce culture: rethinking our 276 indiana health law review [vol. 20:257 and responsibilities83 discourses, following traditional jewish ethics.84 as a result, one should differentiate between whether consensual or nonconsensual sex, including misuse of contraceptive methods, such as condom failure, has yielded the pregnancy. in the first scenario the new discourses should be superior, whereas in the latter the women’s rights discourse should govern.85 the above statements share the assumption that in the case of coerced sexual relationships, the woman owes no duty to the fetus to gestate it, and therefore, her rights discourse should govern.86 however, the relational ethics point of view may significantly strengthen this argument. in a case of rape or incest, the pregnancy is unplanned, thus, the resulting child may be undesired, therefore, the relationship between the gestational mother and the child may lack requisite care. as such, the legal system should not invest with any rights for the fetus and/or obligations for the mother in such a morally meaningless relationship. because the premise of the ethics of care is to promote caring relationships, which support mutual dependency and flourishing, the cases of pregnancy arising from rape or incest may not be loving or caring, resulting in harm to the child. therefore, terminating the relationship by aborting the fetus may be the sound option. in other words, this ethical approach should encourage the law to recognize the gestational mother as the legal mother of the fetus, only when the pregnancy is a result of consensual sexual relations, and rights and responsibilities should be allocated to ensure that this relationship is upheld and maintained. alternatively, in cases of rape, the relationship is unintentional, therefore does not have any moral value and may be terminated by abortion.87 commitments to marriage and family ( vintage books 1997); gillian douglas, obligation and commitment in family law (bloomsbury pub.2018); helen hall, obligation and commitment in family law, 180 law & just. christian l. rev. 103, 103 (2018). 83. see erik h. erikson, insight and responsibility (w.w. norton & co. 1994); john martin fischer & mark ravizza, responsibility and control: a theory of moral responsibility (cambridge univ. press 2000); hannah arendt, responsibility and judgment (random house lc 2009). 84. see moshe silberg, law, and morals in jewish jurisprudence, 75 harv. l. rev. 306, 311 (1961) (“the law itself does not only order relationships between man and man but also between man and god. the system in its entirety is religious in origin and therefore involves obligations to god.”); haim h. cohn, human rights in jewish law 18 (ktav pub. h. inc. 1984); david novak, covenantal rights: a study in jewish political theory 27 (princeton univ. press 2009). 85. margalit & lifshitz-aviram, supra note 73; see also margalit & lifshitz-aviram, supra note 30, at 379 (“[. . .] in the vast majority of cases, at least where the child is a result of consensual relations, the right of the fetus to be born should prevail.”). 86. see cohen, supra note 23; julia dalzell, the impact of artificial womb technology on abortion jurisprudence, 25 wm. & mary j. race gender & soc. just. 327, 347 (2019). 87. see herring, caring, supra note 75; herring, ethics of care, supra note 69; herring, the termination, supra note 68. 2023] from (moral) status (of the frozen embryo) 277 4. the philosophical aspect – personhood and potentiality relational ethics have been discussed in philosophical literature. although relational conceptions of morality existed for centuries, for example, in african88 and asian moral philosophies,89 it is only recently that it has been treated as an independent type of western philosophy. this system of ethics has been defined as being comprised of moral status, virtue, and right action, as constituted by beneficent connections and other sharing bonds.90 as metz and clark miller stated, “relationism is the idea that moral status is constituted by some kind of interactive property between one entity and another, which property warrants being realized or prized.” metz and clark miller explained: according to a relational theory, something can warrant moral consideration even if it is not a group or a member of one, or for a reason other than the fact that it is a member. like holism, though, a relational account accords no moral status to an entity merely based on its intrinsic properties. a relational theory implies that a being warrants moral consideration only if, and because, it exhibits other regarding property, one that is typically intentional or causal.91 since the late 1980s, relationism has traditionally been deeply intertwined with feminist ethics, the ethics of care, which can also be found in many other branches of feminist ethics. generally, care ethics can serve as the infrastructure for a variety of ethics, sentimentalist, ethical, or deontological.92 indeed, as described above in section 2, the gordian knot between feminist ethics and relational ethics has been cut, as is well reflected in the change of title of nel nodding’s 1984 book caring from “feminine” (caring: a feminine approach) 88. see peter paris, the spirituality of african peoples: the search for a common moral discourse (1995) (discussing the ancient african notion of “ubuntu”); gessler muxe nkondo, ubuntu as a public policy in south africa: a conceptual framework, 2 int’l. j. afr. renaissance stud. 88, 88 (2007); thaddeus metz, an african theory of moral status: a relational alternative to individualism and holism, 15 ethical theory & moral prac. 387, 387 (2012). 89. see, e.g., chenyang li, the confucian concept of jen and the feminist ethics of care: a comparative study, 9 hypatia 70, 70 (1994) (example of relationism in asian confucianism); ruiping fan, reconstructionist confucianism: rethinking morality after the west (2010); chenyang li, the confucian philosophy of harmony (2013). 90. see wendy austin, relational ethics, in the sage encyclopedia of qualitative research methods 749 (lisa given ed. 2008). 91. thaddeus metz & sarah clark miller, relational ethics, in international encyclopedia of ethics 1, 2 (hugh lafollette ed. 2016). see also vangie bergum & john dossetor, relational ethics: the full meaning of respect (2005); wendy austin, ethics in a time of contagion: a relational perspective , 40 can. j. nursing res. 10, 10 (2008). 92. see slot, supra note 65; raja halwani, care ethics and virtue ethics, 18 hypatia 161, 161 (2003); sarah clark miller, the ethics of need: agency, dignity, and obligation (2012). 278 indiana health law review [vol. 20:257 to “relational” (caring: a relational approach) in the second edition,93 emphasizing the interconnection of individuals through care, rather than the supposed gendered nature of caring. focusing on one of the philosophical deliberations of the relational approach most relevant to the context of the frozen embryo, jennifer mckitrick, explored the issue of disposition and potentialities, which has been discussed extensively in the literatures of bioethics and philosophy.94 mckirtick analyzes the substantial difference between the embryo’s potentiality between one that is placed in the womb and its duplicate in vitro. she reasoned that while the former has the potential to become a person, the latter lacks it, due, inter alia, to the following: however, another factor is necessary for successful implantation—people with the desire and resources to have the embryo implanted. if so, then the potentialities of frozen embryos depend on interests and resources of would-be fertility clinic patients. an egg selected for implantation would have different potentialities than one not selected [. . .] it seems that there a sense in which an unwanted embryo has diminished potential as compared to its perfect duplicate with willing and able parents.95 one should not adhere solely to a biological parameter when determining the moral status of the frozen embryo, such an inquiry may yield a similar conclusion regarding the analogous in-vitro embryo, if it also has medical “available means” for being implanted in any nurturing uterus. rather, we should retain its relational status as being desired or not. if its progenitors are interested in obligating themselves to a committed and caring relationship vis-à-vis the embryo, the invitro embryo should be defined as having the potential to become a person and consequently enjoy the moral status of a person. without these conditions, it lacks the interrelation potential to become a person and therefore should not be considered akin to a person, and its moral status is much lower than that of a desired embryo.96 93. see text accompanying supra note 58. 94. see, e.g., stephen mumford, dispositions (2003); barbara vetter , potentiality: from dispositions to modality (2015); see also giorgio agamben & daniel heller-roazen , potentialities: collected essays in philosophy (1999). 95. jennifer mckitrick, dispositions and potentialities, in potentiality: metaphysical and bioethical dimensions 49, 65 (john p. lizza ed., 2014). see also jacob c. earl, what we owe to those we make: a causalist account of procreators’ parental obligations 138 (unpub. dissertation, georgetown univ. 2017); jennifer mckitrick, dispositional pluralism (2018). 96. see nicolas delon, moral status, final value, and extrinsic properties, 114 proceedings of the aristotelian society 371, 377 (2014) (presenting a contentious philosophical argument) (“to conclude, then, moral status can depend on extrinsic properties on which efv [extrinsic final value] supervenes (p4). hence, though intrinsic properties, responsible for welfare, surely matter, some extrinsic properties give rise to efv which, when impartially endorsable, can ground ems [extrinsic moral status ].”). for a further discussion of the nexus of relational ethics and the ethical disposition, see gray, supra note 64. 2023] from (moral) status (of the frozen embryo) 279 in section 6, the moral status of the frozen embryo is primarily dependent on the intention of its progenitors regarding whether to bring the child into the world. in the first scenario, where it is a wanted embryo, its moral status is akin to that of a person, and it should not be discarded, whereas in the second scenario, where its progenitors have no interest in it, it is an unwanted embryo, its moral status is like that of a mere good or article, and it can be discarded. 5. the bioethical and sociological point of view – between (individual) biological ethics and relational ethics the notion of “subjectivity of the fetus” is well established in the literature of both bioethics and sociology,97 where one can find two central attitudes toward the moral status of the frozen embryo and the fetus. the first view, and the more accepted one for the past several decades,98 is based on “(individual) biological” ethics,99 which places the fetus/frozen embryo at the center of the moral and legal deliberations as an autonomous and individual being. its status derives exclusively from a variety of biological/scientific factors, such as conception, implantation, cell differentiation, the early formation of a human-shaped fetus, quickening, and viability,100 with no consideration being taken of its social connections and networks with others.101 the more innovative attitude, and the one more relevant to this discussion, is that of “relational (social) ethics,” which conceptualizes the fetus/frozen embryo as a part of its broader social relationships and networks with other individuals, mainly its family members.102 this system of ethics accords great importance to the relational networks and familial relationships of the birthing woman and the family to whom or to which the fetus will be born—how the 97. yael hashiloni-dolev & noga weiner, reproductive technologies and the moral status of the embryo: a view from israel and germany, 30 soc. health & illness 1055, 1055 (2008); r. j. gerber, abortion: parameters for decision, 82 ethics 137, 147 (1972); susan bordo, unbearable weight: feminism, western culture, and the body 85 (2004). 98. thus, the history of the conceptualization of the fetus reflects the history of the medical authority. see luker, supra note 40; barbara duden, disembodying women: perspectives on pregnancy and the unborn (1993); kathryn p. addelson, the emergence of the fetus, in fetal subjects, feminist positions 26 (lynn m. morgan et al. eds. 1999). 99. see lawrence j. kaplan & rosemarie tong, controlling our reproductive destiny: a technological and philosophical perspective 150-52 (1996). 100. see joseph fletcher, humanhood: essays in biomedical ethics 15 (1979); sarah franklin, fetal fascinations: new dimensions to the medical-scientific construction of fetal personhood, in off-centre: feminism and cultural studies 190 (sarah franklin et al. eds., 1991); christopher kaczor, the edge of life: human dignity and contemporary bioethics (2005) (discussing such a scientific approach). 101. see hashiloni-dolev & weiner, supra note 97, at 1064. 102. for this notion in the bioethical-sociological literatures, see, e.g., lynn m. morgan, fetal relationality in feminist philosophy: an anthropological critique, 11 hypatia 47, 47 (1996); tanja krones et al., what is the preimplantation embryo?, 63 soc. sci. & med. 1, 1 (2006). 280 indiana health law review [vol. 20:257 mother will relate to the fetus, whether the baby will be desired by its family, and so on. it describes humanness as a product of cultural reactions and practices, as opposed to the prevailing western individualist conception of morality. a parallel shift can be found—from an individualist to a much more relational conceptualization of the fetus or frozen embryo. in the past, the dominant approach employed an individualistic perspective,103 treating the fetus or frozen embryo as an individual entity with no connections or relationships either to its mother or other family members. this perception, as applied to abortion, focuses on balancing the interests and rights of the different individuals involved, which inevitably results in a clash between the fetus and its mother. however, this decontextualized perception of the embryo has been criticized: none of the perspectives considered so far take into consideration the relationship of the persons and the embryos involved in the context of reproductive technology. most ethical reasoning, be it libertarian, deontological, feminist, or utilitarian separates the embryo from the mother or vice versa.104 opposing this traditional one-dimensional and illusory description of the fetus are numerous justifications for treating the fetus as only one of many factors in the more general equation of pregnancy.105 the close and unique physical interrelationship between the gestating woman and her fetus has been described as an almost mystical bond.106 during the pregnancy, the woman and her fetus are a single, profoundly intertwined entity and cannot be separated, especially as far 103. see, e.g., ronald dworkin, life’s dominion: an argument about abortion, euthanasia, and individual freedom (2011). see also jacquelyn ann k. kegley, using genetic information: the individual and the community, 15 med. & l. 377, 377-86 (1996); robin west, from choice to reproductive justice: de-constitutionalizing abortion rights, 118 yale l.j. 1394, 1394 (2009). 104. tanja krones & gerd richter, preimplantation genetic diagnosis (pgd): european perspectives and the german situation, 29 j. med. phil. 623, 635 (2004); see also claudia wiesemann, relational ethics and the moral status of the embryo, in progress in science and the danger of hubris: genetics, transplantation, stem cell research 117, 120 (constantinos deltas et al. eds. 2006). 105. wiesemann, supra note 104, at 122-23. (“the human being can thus be described as a being whose teleology it is to become a human individual but who for the period of nine months depends on the intimate bodily relationship to another human being . . . human individuality is a mode of existence that makes a reference to other human beings. it does not simply rely on intrinsic but also on relational properties.”). 106. margaret f. brinig, a maternalistic approach to surrogacy: comment on richard epstein’s surrogacy: the case for full contractual enforcement, 81 va. l. rev. 2377, 2383 n.22 (1995); see also marshall h. klaus & john h. kennell, maternal-infant bonding: the impact of early separation or loss on family development (1976); yehezkel margalit, in defense of surrogacy agreements: a modern contract law perspective, 20 wm. & mary j. women & l. 423, 435 (2014); yehezkel margalit, determining legal parentage – between family law and contract law 51 (2019). 2023] from (moral) status (of the frozen embryo) 281 as the fetus is concerned, so one should not ignore the special bonds that the fetus has with its mother. one should not ignore these special bodily and psychological interconnections that cannot be found in any other human relationship. the health and wellbeing of either mother or fetus deeply affects the other and vice versa. these are one human entity whose interests we should evaluate, and not two opposing human rivals.107 as iris m. young expresses it, “[p]regnancy challenges the integration of my body experience by rendering fluid the boundary between what is within, myself, and what is outside, separate. i experience my insides as the space of another, yet my own body.”108 this special biological and psychological oneness, which renders the fetus physically a part of its mother, has been extensively discussed in literature. the mother-fetus bond during pregnancy is profoundly meaningful, and this gordian knot cannot easily be divided in two. as stated by margaret little: to be pregnant is to be inhabited. it is to be occupied. it is to be in a state of physical intimacy of a particularly thorough-going nature. the fetus intrudes on the body massively; whatever medical risks one faces or avoids, the brute fact remains that the fetus shifts and alters the very physical boundaries of the woman’s self. to mandate continuation of gestation is, quite simply, to force continuation of such occupation.109 therefore, the author supports claudia wiesemann’s conclusion: the intrinsic, ontological definition of the human embryo is not helpful in determining its moral status. to be meaningful, every definition must refer to the context of the embryo and to the telos of its development . . . the contextualized definition of the human embryo should ideally refer to its relational status as being the child of somebody.110 107. see herring, ethics of care, supra note 69, at 21; herring, the termination, supra note 68, at 144; jonathan herring & p.-l. chau, my body, your body, our bodies, 15 med. l. rev. 34, 34 (2007). 108. iris m. young, on female body experience: “throwing like a girl” and other essays 49 (2005). see also feminism and philosophy essential readings in theory, reinterpretation, and application 409 (nancy tuana & rosemarie putnam tong eds., 1995); virginia schmied & deborah lupton, the externality of the inside: body images of pregnancy, 8 nursing inquiry 32, 38 (2001). 109. margaret o. little, abortion, intimacy, and the duty to gestate, 2 ethical theory & moral prac. 295, 301 (1999). see also barbara katz rothman, recreating motherhood 89 (1989); anne elvey, the material given: bodies, pregnant bodies and earth, 18 austl. feminist stud. 199, 208 (2003). 110. wiesemann, supra note 104. see also lynn m. morgan & beth a. conklin, babies, bodies, and the production of personhood in north america and a native amazonian society, 24 ethos 657, 657 (1996). 282 indiana health law review [vol. 20:257 6. the jewish law’s perception – the halakhic relational moral status of the frozen embryo the halakhic status of the fetus111 and the frozen embryo has been extensively discussed in jewish law and a deep discussion is beyond the scope of this article. in brief, the general jewish perception of the embryo, especially in vitro, is entirely different from that of catholicism. whereas in the latter, full personhood begins at conception,112 in judaism, the moral status of the frozen embryo is acquired over time. thus, from the moment of fertilization until birth, the fetus gradually becomes increasingly akin to a full person, acquiring its personhood status as its identity changes.113 to the author’s knowledge, there is only one exception to this traditional jewish perspective, that being the unique academic approach of yossi green, who claims, similarly to the catholic conception, that the frozen embryo should be treated as a person to all intents and purposes, including in inheritance law. according to him, the frozen embryo should not be thawed or destroyed, and it has a full right to inherit from its progenitors when it finally comes into the world.114 between these two extremes there are some special halakhic approaches, which may be defined, to varying degrees, as relational. one of the most important jewish thinkers in our generation, aharon lichtenstein stated: the question of abortion involves areas in which . . . the personal circumstances are often complex and perplexing. in such areas there is room and an obligation for a measure of flexibility. a sensitive posek recognizes the gravity of the personal situation and the seriousness of the halakhic factors . . . he may reach for a different kind of equilibrium in assessing the views of his predecessors, sometimes allowing far-reaching 111. see avraham steinberg, encyclopedia of jewish medical ethics: a compilation of jewish medical law on all topics of medical interest 1 (fred rosner trans., 2003); yechiel m. barilan, jewish bioethics: rabbinic law and theology in their social and historical contexts 159-86 (2014); yehezkel margalit, abortion in jewish law (on file with the author). 112. see katheryn d. katz, snowflake adoptions and orphan embryos: the legal implications of embryo donation, 18 wis. women’s l.j. 179, 179 (2003); karin a. moore, embryo adoption: the legal and moral challenges, 1 u. st. thomas j. l. & pub. pol’y 100, 10119 (2007).. 113. see avraham steinberg, jewish perspectives, in the embryo scientific discovery and medical ethic 21 (shraga blazer & etan z. zimmer eds., 2005); daniel b sinclair, jewish biomedical law: legal and extra-legal dimensions 60-61 (2003); barilan, supra note 111. 114. see yossi green, post modern procreation by means of ivf and ibum and haliza, 2 netanya acad. coll. l. rev. 207, 230-40 (2002); yossi green, shall the fertilized ovum be considered an embryo regarding the law of inheritance?, 1 netanya acad. coll. l. rev. 393, 393 (2000); yossi green, procreation in the modern era: legal and halachic perspectives (2008). 2023] from (moral) status (of the frozen embryo) 283 positions to carry great weight and other times ignoring them completely. he might stretch the halakhic limits of leniency where serious domestic tragedy looms or hold firm to the strict interpretation of the law, when as he reads the situation, the pressure for leniency stems from frivolous attitudes and reflects a debased moral compass.115 although lichtenstein is well-known as a conservative halakhic authority (posek) in the abortion field, in this passage, he does not treat the fetus from a dichotomous point of view as either a person or not but expresses a more nuanced and relational perspective. according to lichtenstein, the moral status of the fetus depends on the specific circumstances of each case, leaving room, and even an obligation, for the adjudicator to be much more flexible and lenient. this is not a “one size fits all” halakhic decision based on the fetus’s ontological definition, but a consequence of the condition and situation of the woman asking for the abortion.116 in other words, since the woman’s “personal situation” plays a significant role in halakhic decision-making on abortion, there is the option of reaching a subjective ruling in each situation. when “serious domestic tragedy looms,” the judge or arbiter has the freedom to stretch the limits of halakhah, clearly echoing the relational approach’s emphasis on the contextual nature of the moral decision.117 put differently, the “subjectivity of the fetus” or relational approach may be found also in judaism, and even in one of its most conservative authorities, despite judaism being one of the most formalistic religions.118 115. aharon lichtenstein, abortion: a halakhic perspective, in 25 tradition 3, 11 (1991); see also alan jotkowitz, abortion and maternal need: a response to ronit irshai, 21 nashim j. jewish women’s stud. & gender issues 97, 103 (2011); benjamin gesundheit, fate and judaism–philosophical and clinical aspects , in knowing one’s medical fate in advance: challenges for diagnosis and treatment, philosophy, ethics and religion 80 (manuel battegay et al. eds., 2012). 116. see more extensively at alan jotkowitz, “halakhah loved not the parents less, but the child more”: r. aharon lichtenstein on abortion, 47 tradition 137, 150-56 (2015); alan jotkowitz, on the methodology of jewish medical ethics, 43(1) tradition j. orthodox jewish thought 38, 50 (2010); alan jotkowitz et al., abnormalities mild with fetuses for abortions, 12 israel med. ass’n j. 5, 7-8 (2010). 117. for the halakhic jurisprudence of other decisions regarding this issue, see joseph b. soloveitchik, halakhic man 23 (1984) (not leaving much room for the impact of the human and social factors on halakhic decision making); elliot n. dorff, matters of life and death: a jewish approach to modern medical ethics 412 (1998) (differentiating between a rule-based ethic and a situational ethic). 118. for this substantial character of judaism, see, e.g., aaron kirschenbaum, equity in jewish law: halakhic perspectives in law; formalism and flexibility in jewish civil law (1991); leon sheleff, the formalism of jewish law and the values of jewish heritage, 25 tel aviv u. l. rev. 489, 489 (2001-2002) (heb.); avishalom westreich, flexible formalism and realistic foundationalism: an analysis of the artificial procreation controversy in jewish law, 31 dine israel 157 (2017) (heb.). 284 indiana health law review [vol. 20:257 this relational perspective can be found also in one of the most central concerns of judaism—the legitimization of abortion on the grounds of extramarital sex, to prevent the birth of a mamzer (“bastard”). according to jewish law, when a married woman has a sexual relationship with another jew to whom she is not married, the offspring is regarded as a mamzer.119 that child, if a male, and all his descendants cannot marry a jewish woman unless she herself is a mamzer or proselyte.120 the birth of a mamzer has well-known and far-reaching halakhic ramifications for the newborn, which can cause his parents and the whole family great shame and place a heavy psychological burden on them. it is therefore permitted, according to some prominent halakhic authorities, to abort the fetus. while the moral status of the fetus severely restricts the option of abortion, the resulting mamzer’s inevitably sour relationship with his family challenges this prohibition. this result is based on the same grounds as that of the relational approach. the choice between prohibiting and allowing the abortion of the same fetus obviously stems from a relational and not an individualist point of view. as was claimed by daniel b. sinclair: even in the mamzer fetus cases, the main rationale behind the permissive rulings was the saving of the mother from the adverse effects, both psychological and physical, of giving birth to tainted progeny [. . .] it is certainly arguable that the abortion of a mamzer fetus has as much to do with prevention of mamzerim being born as it does with the mental and physical welfare of the mother.121 an interesting variety of similar opinions can be found concerning the halakhic status of the frozen embryo. while the vast majority of halakhic authorities have ruled that it can be thawed or destroyed, some argue that this is 119. see ben zion schereschewsky, “mamzer” in the principles of jewish law 435-38 (menachem elon ed., 1975); pamela laufer-ukeles, the lost children: when the right to children conflicts with the rights of children, 8 l. & ethics hum. rts. 219, 242-45 (2014). for the concept and importance of purity and holiness that should be part of the conjugal relationship, see chaim povarsky, regulating advanced reproductive technologies: a comparative analysis of jewish and american law, 29 u. tol. l. rev. 409, 413-16 (1998). for a social anthropological criticism of the politics of mamzerut, see susan m. kahn, reproducing jews: a cultural account of assisted conception in israel 78-80 (2000). 120. see more extensively at yehezkel margalit, the jewish family – between family law and contract law 140 (2017); yehezkel margalit, towards establishing parenthood by agreement in jewish law, 26 am. u. j. gender soc. pol’y & l. 647, 653-54 (2018). 121. sinclair, supra note 113, at 59-60. see also hashiloni-dolev & weiner, supra note 97, at 1059. for a discussion of the severe and dramatic results of being labeled a mamzer, which can consequently put social pressure and “religious duress” on his mother, see yehezkel margalit, bargaining in the shadow of get refusal: how modern contract doctrines can alleviate this problem, 36 ohio st. j. on disp. resol. 153, 176-80 (2020). for another aspect of the jewish and israeli relational ethics’ point of view, see deborah lupton, the social worlds of the unborn 76 (2013). 2023] from (moral) status (of the frozen embryo) 285 absolutely prohibited, as claimed by one of the most prominent jewish authorities in the united states, david j. bleich, who stated, “there are no obvious grounds for assuming that nascent human life may be destroyed simply because it is not sheltered in its natural habitat, i.e., its development takes place outside the mother’s womb.”122 likewise, about five years ago, a detailed ruling was handed down that, for the first time, dealt with a mutual request to destroy the frozen embryos after the dissolution of a couple’s marriage. the rabbinical court in tel aviv absolutely prohibited destroying frozen embryos unless there was an acute need to do so, and even then, only under extreme restrictions.123 but a careful reading of the countless jewish texts that have been written regarding this issue since the advent of the first ivf baby in 1978 reveals a more complicated point of view, which can also be defined as relational. the following statement was delivered by hayyim d. halevi, the former chief rabbi of tel aviv-jaffa: all ova that are fertilized in vitro do not have the legal status of an embryo; one does not violate the sabbath on their behalf, and it is permissible to discard them if they were not chosen for transfer, since the law of abortion only applies to [an embryo] in the womb . . . in vitro, there is no prohibition whatsoever.124 from his perspective, there is no dichotomous definition of the frozen embryo as either a person or not—the doctrine of fetal personhood being “all or nothing”—and its moral status merely depends on its telos and destination. if the intent of its progenitors is to discard it, it has no halakhic significance and can be destroyed. but if the intention is to become parents by transferring and implanting 122. david j. bleich, in vitro fertilization: questions of maternal identity and conversion, 25 tradition 82, 97 (1991); as mentioned by aaron l. mackler, in vitro fertilization, in responsa: 1991-2000, the committee on jewish law and standards of the conservative movement 519 (k. abelson & d. fine eds., 2002); aaron l. mackler, an expanded partnership with god? in vitro fertilization in jewish ethics, 25 j. religious ethics 277, 290 (1997); aaron l. mackler, jewish perspectives on embryo and stem cell research , in religious perspectives on bioethics 147, 149 (mark cherry ed., 2013). 123. rabbinical court (ta) 1049932/8 anonymous v. anonymous 1, 28-29 (unpub. july 20, 2016) (isr.). for an academic discussion of this verdict, see margalit, the jewish family, supra note 120, at 153 n.84. but compare with the opinion of judge shlomo dichovsky, who claims that the frozen embryo has an independent right to be born and consequently the rabbinical court should, only orally, push the insubordinate party to release it to the other party who is eager to become a parent. 124. hayyim d. halevi, on fetal reduction and the halakhic status of in vitro embryos, 47 applied soc. sci. index & abstracts 14, 15 (1990) (heb.) (emphasis added). for a similar ruling, see yitzhak zilberstein, the evaluation of the pre-embryo before implantation for prevention of defective embryos and gender determination, 51 applied soc. sci. index & abstracts 54, 56 (1992) (heb.). see also david m. feldman & fred rosner, compendium on medical ethics: jewish moral, ethical and religious principles in medical practice 51 (6th ed. 1984); shalom & hashiloni-dolev, supra note 16, at 179. 286 indiana health law review [vol. 20:257 it in the woman’s womb, it is more akin to a person, and destroying it is prohibited. a similar perception can be found in the writing of mordehai eliyahu, the former chief rabbi of the state of israel, who uses a similar litmus test regarding the moral status of the frozen embryo. eliyahu claims that the frozen embryo’s status is relational, deriving directly from whether its progenitors (or at least by its producers, where they are created for use by others than the progenitors) intend to use it to procreate. if the main goal in creating the frozen embryo is for it to become a new life, it should not be discarded, since it can potentially yield a living baby, but if its destination is anything other than procreational, it can be thawed. as he puts it, “[f]ertilized ova that have been designated for transfer to a woman’s uterus should not be destroyed, since a live fetus will develop from them, but fertilized ova that have not been designated for transfer may be discarded.”125 the relational aspects of this unique jewish approach were summarized by yechiel m. barilan: this is an illuminating example of halakhah’s empiricist and relational approach, even at the expense of obvious metaphysical considerations. the rabbis . . . ignoring completely the question – “what kind of creatures are they?” consequently, extracorporeal embryos in vials bear no special status in jewish law.126 the author previously pointed to a related halakhic subjectivity—the determination of legal motherhood in egg donation and surrogacy. there are two possible reliable factors for establishing halakhic motherhood—the genetic element embedded in the egg donation, and the physiological element of the gestational mother. this article argued that this halakhic subjectivity allows more room for taking into consideration the intent of the individuals who were involved in the “creation” of the resulting child, who should be recognized as its legal parents. therefore, in any case of egg donation, where the genetic mother and the gestational mother are different individuals, the intentional parenthood—or determining parenthood by agreement (“dlpba”), as coined by the author—may establish the legal motherhood. thus, there appears to be no agreed-on determinative factor in establishing 125. mordehai eliyahu, destroying embryos and fetal reduction, 11 tehumin 272, 272-73 (1990) (heb.), as discussed by mackler, an expanded partnership with god?, supra note 122; mackler, jewish perspectives, supra note 122; gideon a. weitzman et al., genetic counseling for the orthodox jewish couple undergoing preimplantation genetic diagnosis, 21 j. genetic counseling 625, 626 (2012). 126. barilan, supra note 111, at 153 (emphasis added). for a broader discussion of the nexus of the relational approach and judaism, see ron wolfson, relational judaism: using the power of relationships to transform the jewish community (2013); renée schlesinger, clinical social work with orthodox jews: a relational approach, in relational social work practice with diverse populations 179 (judith b. rosenberger ed., 2014); tanya zionwaldoks, politics of devoted resistance: agency, feminism, and religion among orthodox agunah activists in israel, 29 gender & soc’y 73, 73 (2015). 2023] from (moral) status (of the frozen embryo) 287 halakhic maternity . . . since there are two factors in establishing legal maternity – genetic and gestational – there is more room for applying my normative model of dlpba in determining halakhic maternity.127 dlpba should also determine the halakhic maternity in any case of surrogacy, where, not infrequently, the intending mother is also the genetic mother. furthermore, the intending father must also be the genetic one, according to halakhic restrictions, which were anchored as one of the central prerequisites in the israeli surrogacy law: therefore, a priori, there is no particular problem in determining the intended parents, who in most cases are also the genetic parents, as the legal parents of the resulting child . . . since there is no definitive halakhic determination as to who should be designated the legal mother in cases of ivf and surrogacy, there is more room for applying dlpba as a means for recognizing the intended and genetic mother as the legal mother due to her initial agreement to serve as the legal mother of the conceived child.128 the question remains whether the initial intentions of the progenitors, which not infrequently are formalized in an explicit agreement, can influence and perhaps even determine the moral status of the frozen embryo. 7. towards a relational moral status of the frozen embryo129 i. general in this normative section, the essential thrust of the article, the author enlists 127. margalit, the jewish family, supra note 120, at 157. for a broader discussion of dlpba as the best normative model for determining legal parenthood in various scenarios, see margalit, determining legal parentage, supra note 106 . for its practical implementation in domestic and international surrogacy arrangements, see respectively margalit, in defense of surrogacy agreements, supra note 106; yehezkel margalit, from baby m to baby m(anji): regulating international surrogacy agreements, 24 j. l. & pol’y 41, 41 (2016). 128. margalit, the jewish family, supra note 120, at 160; margalit, towards establishing parenthood by agreement in jewish law, supra note 120, at 676. for the massive influence of judaism on the regulation of the israeli surrogacy law, see carmel shalev, halakha and patriarchal motherhood an anatomy of the new israeli surrogacy law, 32 isr. l. rev. 51, 51 (1998); rhona schuz, surrogacy in israel: an analysis of the law in practice, in surrogate motherhood: international perspectives 35 (rachel cook et al. eds., 2003); ruth zafran, more than one mother: determining maternity for the biological child of a female same-sex couple – the israeli view, 9 geo. j. gender & l. 115, 129 n.70 (2008). for a related call to differentiate the halakhic motherhood for various contexts, see avishalom westreich, changing motherhood paradigms: jewish law, civil law, and society, 28 hastings women’s l.j. 97, 10495, 111-14 (2017). 129. for a related title, see jeanne louise carriere, from status to person in book i, title i of the civil code, 73 tul. l. rev. 1263, 1263 (1999). 288 indiana health law review [vol. 20:257 the notion of relational contract as it applies to our issue—the status of the frozen embryo. this article will explore how this modern and unique contract better resolves the two abovementioned problems in the frozen embryo field—their moral and legal status—and how to contractually regulate which of their progenitors may control them. relational contract is also greatly influenced by relational ethics, although the precise relationship between them has not been sufficiently discussed in the legal literature.130 as was briefly elaborated above in section 1,131 one of the major problems stemming from the dilemma over the moral and legal status of the frozen embryo is how to contractually determine custody of it and whether to enforce the contract, explicit or oral, if any such exists, against the will of one of the parties. regarding this dilemma, there are three primary approaches: (1) the contractual approach, which endorses the enforcement of contracts signed prior to undergoing ivf treatment; (2) the contemporary mutual consent model, which requires the agreement of the two progenitors for any disposition of the frozen embryos; and (3) the balancing of constitutional rights regarding procreative autonomy.132 primarily, the advantages of a disposition agreement and briefly recall the pitfalls of contractual ordering in this sensitive field are worth mentioning. subsequently, the author will elaborate on the main aspects of the relational contract and how it provides considerable assistance in resolving these drawbacks. finally, the question of “can one use the relational contract to determine the legal status of the frozen embryo?” will be addressed. ii. the advantages of a disposition agreement elsewhere,133 the author extensively argued that in the field of ivf in 130. for an academic discussion of the nexus of relational ethics and relational contract, see peter linzer, uncontracts: context, contorts and the relational approach, 1988 ann. surv. am. l. 139, 162 (1988) (“although the feminist writers have not focused much on contracts, their thesis is most relevant [to relational contract theory]”; lúcia helena barbosa de oliveira, a localized re-definition of legal justice: the feminine of the south in the early constitutional transition and its practice by the consumer protection office of the mpdft-brasiliabrazil a framework for cross-border disputes in ec consumer law and policy 15, 76, 88-89 (2009); amy j. schmitz, sex matters: considering gender in consumer contracting, 19 cardozo j. l. & gender 437, 455-60, 470-75 (2013). 131. see text accompanying supra note 24-26. 132. for a discussion of these rights, see lambert, supra note 19, at 541-48; lupsa, supra note 27, at 954-61; wheatley, supra note 7, at 306-11; walter, supra note 22, at 969 (enumerating four models for the resolution of any conflict regarding their disposition – a contract analysis, the implied contract theory, the bundle of rights balancing test, and the criterion of exclusive control to the biologic donors). alex m. johnson, the legality of contracts governing the disposition of embryos: unenforceable intra-family agreements, 43 sw. l. rev. 191, 213 (2013) (“recount[s] the five prevailing views among academics[.]”). 133. margalit, determining legal parentage, supra note 106, at 114. see also yehezkel 2023] from (moral) status (of the frozen embryo) 289 general, and especially with disposition agreements regarding frozen embryos, intentional parenthood, or dlpba have many advantages. such agreements provide the parties, the fertility clinic, and the court with clarity, certainty, efficiency, and flexibility regarding the deliberate intentions of the individuals involved in this process. such an agreement may effectively minimize the length and bitterness of any potential future dispute, while providing appropriate guidelines and tools for achieving the best and most just solution if such disagreement eventually arises. in these intimate scenarios, the parties who “possess” the genetic material(s), and not the court or any other extension of the state, are the most fit to determine what the embryo’s fate will be. the enforceability of such agreements ensures the parties’ seriousness, which induces them to diligently negotiate their desires, intentions, and commitments, and accordingly reduces the possibility of conflicts later. recognizing the legality of such agreements may enormously assist courts in enforcing private arrangements without unnecessarily invading the intimate sphere of those couples and their opposing interests. it may dramatically reduce the unethical use of frozen embryos, which has the potential to harm the contractual parties, and provide maximum flexibility in adjusting each given arrangement to the desires, agreements, and intentions of the specific parties.134 as mentioned above in section 1,135 two of the main shortcomings of such private ordering concern a change of mind by one of the progenitors, the parties to the contract, and unforeseeable or changed circumstances. these two contractual drawbacks can deprive contractual ordering of any of its advantages and render the whole of the contract void, or at least dramatically impair its enforceability. iii. relational contract this theory, arguably a branch of relational ethics, emerged in the 1970s as a reaction to classical contract law’s limitations; some even argue that it is a “mirror image” of the traditional contract model and the answer to current realmargalit, to be or not to be (a parent)? not precisely the question; the frozen embryo dispute, 18 cardozo j. l. & gender 355, 355 (2012). for the dilemma of whether the enforcement of any given contract yields certainty and reduces complexity, or it offers a false (and expensive) promise of certainty, see ronald j. gilson et al., braiding: the interaction of formal and informal contracting in theory, practice, and doctrine, 110 colum. l. rev. 1377, 1377 (2010). 134. for additional implementations of dlpba in other scenarios concerning the dilemma of how to determine the legal parentage of the resulting child, in same-sex couples, in innovative fertility treatments, and in artificial insemination from donor, see yehezkel margalit, intentional parenthood: a solution to the plight of same-sex partners striving for legal recognition as parents, 12 whittier j. child & fam. advoc. 39, 39 (2013); yehezkel margalit & john loike, the new frontier of advanced reproductive technology: reevaluating modern legal parenthood, 37 harv. j. l. & gender 107, 107 (2014); yehezkel margalit, artificial insemination from donor (aid) – from status to contract and back again?, 21 b. u. j. sci. & tech. l. 69, 69 (2015). 135. see text accompanying supra note 25-26. 290 indiana health law review [vol. 20:257 world situations that arise.136 the relational contract theory was fueled by the criticism of ian r. macneil following empirical studies on the gap between the initial contractual rights and obligations, and those that are applied during the contract’s performance.137 the conception of the ideal contractor under classical contract law was a selfsufficient, informed, and autonomous agent, who is free to contract with everyone and to dictate his own stipulations as he wishes. the keystone of this conception is the separateness and individual autonomy of each party to the contract and not the values of connection and relationship. the values promoted by this classical theory are therefore self-interest, free markets, self-sufficiency, and personal profit maximization.138 in contrast, the relational contract emphasizes the relational dimension of the contracting process, which is characterized by cooperation, trust, flexibility, and even altruism.139 the relational contract is designed to promote other values that are central to our flourishing as human beings: mutuality, relationships, and interdependency. one should not treat the other party as merely a source of potential profit, but as a vulnerable person with whom we should contract fairly. in fact, one should ensure fairness and be sensitive to the context of the relationship accompanying any given contract. the contract should promote a relationship with fair sharing of the gains and losses, acting in good faith by recognizing each other’s vulnerability, and cooperating with each other through any hardships one may encounter.140 indeed, many sociologists and psychologists also contend that there are extrinsic relational factors that influence the contract’s performance, primarily the importance of keeping promises, consideration of the other’s needs, and the parties’ readiness to cooperate.141 this pertains less to discrete short-term 136. see melvin a. eisenberg, why there is no law of relational contracts, 94 nw. u. l. rev. 805, 812 (2000). 137. robert w. gordon, macaulay, macneil, and the discovery of solidarity and power in contract law, 1985 wis. l. rev. 565, 570 (1985). for an extensive discussion of the relational contract, see margalit, supra note 106, at 452-56. 138. see peter linzer & patricia a. tidwell, the flesh-colored band aid-contracts, feminism, dialogue, and norms, 28 hous. l. rev. 791, 791 (1991); sharon thompson, prenuptial agreements and the presumption of free choice 132-33 (2015); jonathan herring, vulnerable adults and the law 226-28 (2016). 139. see ian r. macneil, relational contract: what we do and do not know, 1985 wis. l. rev. 483, 482 (1985); implicit dimensions of contract: discrete, relational, and network contracts (david campbell et al. eds., 2003); mindy chen-wishart, beyond influence: beyond impaired consent and wrongdoing towards a relational analysis, in mapping the law: essays in memory of peter birks 201, 220 (andrew burrows & alan rodger eds., 2006). 140. mary joe frug, re-reading contracts: a feminist analysis of a contracts casebook, 34 am. u. l. rev. 1065, 1065 (1985); linzer & tidwell, supra note 138; herring, supra note 138, at 257-62. 141. for the phrase “mirror image,” see eisenberg, supra note 136, at 812. for further 2023] from (moral) status (of the frozen embryo) 291 transactional contracts than it does to long-term contracts between two stable contracting parties, which represent a long-term extra-contractual relationship that develops mutual interests, expectations, and interdependency. the unique longterm relationship, which may be driven by public values, such as justice, solidarity, dependency, and fairness, requires close cooperation and even altruistic motivations. according to the common relational contract theory, the interdependency of the parties causes them to assign less weight to the initial planning and documentation of the contract and its stipulations, and more weight to the flexible, reciprocal, and considerate behavior of the two sides. this means that the agreement is dynamic and should not be inspected solely now of its execution, but throughout its performance as well. when changed circumstances occur, the sides should consider each other’s needs and not insist on following the terms of the initial agreement. instead, they should adjust the agreement to new circumstances in recognition of the dynamic and flexible character of the modern contract. it is difficult to speak today about one singular relational contract theory, since one can find a variety of theories developed by scholars in research literature.142 likewise, the prevailing contention is that in any given contract, one can find some aspects of the relational contract, and as contracts reflect more and more of the relational contract’s special character, one should treat that given contract in a more communal and public attitude.143 scholars disagree as to whether the relational contract deserves special regulation in addition to the classical and modern law models,144 or whether it fits into the latter model.145 discussion, see ewan mckendrick, the regulation of long-term contracts in english law, in good faith and fault in contract law 305, 312 (jack beatson & daniel friedmann eds., 1995); see also stuart macaulay, non-contractual relations in business: a preliminary study, 28 am. sociol. rev. 55, 57 (1963). for empirical studies, see, e.g., gordon, supra note 137, at 560. for a survey of sociological and psychological research, see stewart macaulay, an empirical view of contract, 1985 wis. l. rev. 465, 465 (1985); stewart macaulay, the real and the paper deal: empirical pictures of relationships, complexity, and the urge for transparent simple rules, 66 mod. l. rev. 44, 44 (2003). 142. for further discussion on the various relational contract theories in macneil’s writing, see ian r. macneil, relational contract theory: challenges and queries, 94 nw. u. l. rev. 877, 881 (2000). 143. see ian macneil, the many futures of contracts, 47 s. cal. l. rev. 691, 738-40 (1974); ian macneil, contracts: adjustment of long-term economic relations under classical, neoclassical and relational contract law, 72 nw. u. l. rev. 854, 854 (1978); ian macneil, the new social contract: an inquiry into modern contractual relations 28 (1980); ian macneil, the relational theory of contract: selected works of ian macneil (david campbell ed., 2001). 144. see melvin a. eisenberg, the limits of cognition and the limits of contract, 47 stan. l. rev. 211, 251 (1995). 145. see mckendrick, supra note 141, at 332; eisenberg, supra note 141, at 806; robert e. scott, the case for formalism in relational contract, 94 nw. u. l. rev. 847, 848 (2000). 292 indiana health law review [vol. 20:257 scholars also disagree on how this sort of contract should be operatively implemented.146 despite the vast amount of scholarly literature, the relational contract theory has yet to reach full maturity, and, to date, it has been applied mostly in the long-term contract realm. some scholars nonetheless anticipate that the relational contract will gain greater influence.147 today, many practical implementations of this theory can be found in various legal relationships, specifically in the fields of insurance, employment, arbitration,148 and biotechnology.149 thus, the relational contract theory should be applied to disposition agreements as well. the special relationship embodied in this unique contract, which includes contracting parties who are not necessarily married spouses, is very subjective, complex, close, and intimate. likewise, this sensitive and complicated arrangement may be long-term, since very often it is not clear when it will expire, whether it will achieve its goal, or when exactly it will do so. there is even the possibility that if the current ivf cycle is successful, the sides will agree on a second. a compelling argument can be made that the disposition agreement conforms to the typical characteristics of relational contract theory and therefore should be treated as a relational contract. in addition, the contracting parties may not be well trained or aware of all the various nuances of the contract and the difficulties inherent in the fertility treatment process, the pregnancy process, and the delivery. moreover, often one or both progenitors may not be represented by a lawyer and may blindly rely on the adhesion contract dictated by the fertility clinic. a flexible and just contractual theory that accounts for the special and subjective characteristics of the contracting parties, the possibility of a change of heart, the possibility of changed circumstances, and all the other additional contractual or legal factors may be most appropriate for the contractual ordering of this field.150 146. see jay m. feinman, the insurance relationship as relational contract and the “fairly debatable” rule for first-party bad faith, 46 san diego l. rev. 553, 554 (2009). 147. see gordon, supra note 137, at 566. 148. for a similar modern implication, see gordon, supra note 137, at 556-59. 149. see walter w. powell, networks of learning in biotechnology: opportunities and constraints associated with relational contracting in a knowledge-intensive field, in expanding the boundaries of intellectual property: innovation policy for the knowledge society 251, 252-53 (rochelle cooper dreyfuss et al. eds., 2001). 150. for a related call to define a disposition agreement as a relational contract, see johnson, supra note 132, at 229 (“none to date has acknowledged that the agreement or ‘contract’ entered into by the parties to dispose of gametic material is made by the parties who have already embarked upon another long term relational contract the contract of marriage.”). for a similar understanding regarding a surrogacy contract, see margalit, in defense, supra note 106, at 454-56. see also flavia berys, interpreting a rent-a-womb contract: how california courts should proceed when gestational surrogacy arrangements go sour, 42 cal. w. l. rev. 321, 345-47 (2006); hillary l. berk, the legalization of emotion: managing risk by managing feelings in contracts for surrogate labor, 49 law & soc’y rev. 143, 148 (2015) (“surrogacy is a doubly relational contract”). 2023] from (moral) status (of the frozen embryo) 293 this innovative concept needs to be homed on in several respects. a disposition agreement may encounter difficulties, such as the dissolution of the progenitors’ relationship or their divorce, loss of legal capacity, the death of one of the parties, or the progenitors’ unexpected success in achieving a child from natural intercourse. mutual expectations, obligations, and reliance on the contract may vary over time, since it is almost impossible to foresee all the possible changed circumstances, which may easily cause a change of heart. the essence of a disposition agreement is to privately order a very personal and complicated relationship that is not a common economic transaction by its very nature, and embodies substantial personal, social, and psychological needs. it is also difficult to evaluate and estimate its full and appropriate consideration. the contractual obligations are not always transferable to someone else, and they are supported by a social support system with especially important values, such as the right of procreation. the importance of cooperation is therefore substantial, and there is even a readiness for altruism. because the relational contract theory holds that at the initial contract execution stage, there is no ability to foresee and formulate all the appropriate obligations and rights attendant upon the contractual relationship, the de facto performance of the contract should be mandatory only in specific cases where it is ultimately deemed necessary.151 the relational contract theory may support and even strengthen the notion that the parties may withdraw from one or more of the contractual obligations embedded in the disposition agreement. this is true not only after the contract’s execution and prior to the beginning or success of the fertility treatments, where the balanced interests still enable one of the sides not to fulfill their contractual obligations. the relational contract theory may create parental obligations, rights, and even the granting of parenthood status itself due to an implied agreement following de facto guardianship. my line of reasoning means that the implication of the relational contract theory may require, if necessary, flexible adjustment of the contractual obligations ex-post, in addition to the initial obligations that were agreed upon ex-ante. these potential adjustments and the need for flexibility may then allow for change to the initial agreement where there is a change of heart or changed circumstances and the de facto performance of the contract by both sides, explicitly or implicitly, indicates that the parties agree to change the initial agreement. practically speaking, even if the initial agreement had stipulated that the frozen embryos should be used, donated to another couple, used for research, or destroyed, the performance of the contract may, under given circumstances, dictate a different result following and according to the parties’ change of minds. 151. charles j. goetz & robert e. scott, principles of relational contracts, 67 va. l. rev. 1089, 1091-92 (1981); ethan j. leib, contracts and friendships, 59 emory l.j. 649, 649 (2010). see also johnson, supra note 132, at 240 (“indeed, it is quite obvious and apparent that the parties who made the agreement, stylized by most courts as a ‘contract,’ are not in the same place or, more to the point, same relationship that they were in at the time they made the agreement. in brief, at the time of making the agreement one would presume that the parties are in an amicable long-term cooperative relationship that is the epitome of a relational contract.”). 294 indiana health law review [vol. 20:257 a. relational ethics, relational contract and relational status in recent legal literature, one can also increasingly find a conceptualization of the spousal relationship as a relational contract.152 it is worth noting that in his early writings, macneil conceptualized the marriage contract as a relational contract.153 but, in stark contrast to the prevalence of this implementation in the spousal relationship, it is sorely lacking in the parent-child relationship. the author explored this possibility in several of my previous articles and a forthcoming book.154 there is no doubt that nothing compares to the strong relational aspects of both the parent-child and spousal relationships, since there is nothing “as important and relational as raising a child.”155 this is a lifetime commitment and endeavor for the couple, the two progenitors, which has been illustrated by the well-known observation that “[i]t takes a village to raise a child,” as some scholars have put it.156 as has been further elaborated, our parenting is inherently and deeply co-operative with the caring (whether we describe it as parenting) of our partners. our parenting makes no sense without a consideration of our partner’s role . . . we may offer those children—but not others—an adequate level of parenting. even then we could only really answer the question by reference to the parenting we are able to offer our children in the context of the relationships, community and society which are all involved in parenting.157 recently, it has been claimed that there is nothing inherent in marriage that renders the married couple the legal parents of the child, but rather, legal 152. see macneil, the many futures of contracts, supra note 143, at 720-21. see also elizabeth s. scott & robert e. scott, marriage as relational contract, 84 va. l. rev. 1225, 123032 (1998); robert leckey, relational contract and other models of marriage, 40 osgoode hall l.j. 1, 1 (2002); elizabeth s. scott & robert e. scott, from contract to status: collaboration and the evolution of novel family relationships, 115 colum. l. rev. 293, passim (2015). 153. see macneil, contracts: adjustment of long-term economic relations under classical, neoclassical and relational contract law, supra note 143, at 857-58; see also gordon, supra note 137, at 569 (conceptualization of relational contract theories in terms of marriage in the writings of macneil and macaulay). see also margalit, supra note 121. 154. see yehezkel margalit, from the tender years doctrine to the approximation rule – between family law and contract law, 15 haifa l. rev. 15 (2021); yehezkel margalit, parent-child relationships between family law and contract law (bar-ilan univ. press, 2022) (heb.) (forthcoming). see also melanie b. leslie, enforcing family promises: reliance, reciprocity, and relational contract, 77 n.c. l. rev. 551, 551 (1999). 155. johnson, supra note 132, at 214, n.186-87 and accompanying text. 156. jane cowen-fletcher, it takes a village (1994); does it take a village? community effects on children, adolescents, and families (alan booth & ann c. crouter eds., 2001); hillary rodham clinton, it takes a village and other lessons children teach us (2006). 157. foster & herring, supra note 44, at 37-38. 2023] from (moral) status (of the frozen embryo) 295 parentage is found in the relationship between every, often two, individuals that have agreed to mutually raise a child, even if they are not officially married.158 indeed, the relational approach emphasizes the ongoing caring, interdependency, and committed relations of the individuals who intend to mutually raise the child, rather than the official status of their relationship. hence, only an intending parent who is committed to such a long-term relationship should be determined as the legal parent of the resulting child.159 the other side is that any progenitor who is not interested in obligating him or herself with this lifetime commitment should not be determined as the legal parent. this is not only due to the individual’s right not to procreate, but because under the relational approach, such a non-caring relationship toward the second individual, and consequently toward the resulting child, should not be morally recognized by legally imposing on that individual the status and obligations of a legal parent.160 the mutual relational responsibilities and commitments of the two individuals raising the child to maturity, whether they are married to each other or not, constitute an around-the-clock relationship based on commitment, dependency, and care.161 these relational features were extensively explored in section 3 in the pregnancy and abortion context regarding only the pregnant woman, but they are even more salient regarding the resulting child and the two individuals raising the child. indeed, the relational notions of commitment, responsibility,162 and obligation163 have become central in the past decades in the 158. ayelet blecher-prigat, conceiving parents, 41 harv. j. l. & gender 119, 119, 176 (2018). (“existing laws and legal scholarship have focused either on biology or on intent but have overlooked relationships . . . this article’s primary goal has been to introduce the relationship between the conceiving adults as an additional key factor in making parentage determination. adding relationships as a factor emphasizes reliance, equality, and commitments[.]”). see ayelet blecher-prigat, rethinking visitation: from a parental to a relational right, 16 duke j. gender l. & pol’y 1, 1 (2009) (for the relational traits of a variety of angles of the parent-child relationship); ruth zafran, children’s rights as relational rights: the case of relocation, 18 am. u. j. gender soc. pol’y & l. 163, 1163 (2009-2010); pamela laufer-ukeles, the relational rights of children, 48 conn. l. rev. 741, 741 (2016). 159. see berg, owning, supra note 11, at 161. (“nonetheless, some contracting parents may make the argument that the embryo in question is closely linked to their senses of self, and these arguments should be taken seriously.”). 160. for my previous call to differentiate between three typical statuses of legal parent–full parental, partial parental and non-parental–depending on the range of their parental undertakings, see margalit, supra note 133, at 372-74; yehezkel margalit, bridging the gap between intent and status: a new framework for modern parentage, 15 whittier j. child & fam. advoc. 1, 26-28 (2016); margalit, determining legal parentage, supra note 106, at 163-68. 161. for a recent survey of the strengthening of the responsibilities and commitments discourses in the child-parent context, see margalit & lifshitz-aviram, supra note 73, at iiic. 162. see julie wallbank, parental responsibility, and the responsible parent: managing the “problem” of contact, in responsible parents and parental responsibility 296 (rebecca probert et al. eds., 1st ed. 2009). see also john eekelaar, parental responsibility: state of nature or nature of the state?, 13 j. soc. welfare & fam. l. 37, pincite (1991); jonathan herring, 296 indiana health law review [vol. 20:257 context of the parent-child relationship. as wiesemann argued, parenthood is a good example for a human relationship that cannot be grasped by resorting to rights or even duties. it is a life-long responsibility based on unconditional love for the child . . . loving care cannot be put into the language of rights or duties. if we attempt to put the moral meaning of loving care into the language of rights and duties, we will miss the essential point.164 that is the case concerning not only the fetus in its mother’s uterus, but also the frozen embryo. since raising the resulting child will be a lifetime relational commitment, obligation, and responsibility for its progenitors, society should respect any mutual agreement between them. if both are interested in bringing the child into the world by themselves (or donating it to another infertile couple), the relationship of the intended parents toward each other (themselves or the “adopting” parents) and mutually toward the resulting child will be nurturing and marked by care. consequently, the moral and legal status of the given frozen embryo should more closely resemble that of a person, as nel noddings claimed about its relational ontology, where the ethical self is a consequence of the relationship of caring with others, and as also concluded in the bioethicalsociological literature, discussed above in section five.165 similarly, claudia wiesemann argues that: a relational ethics approach focusing on the meaning of parenthood can replace the ethics of rights and duties where appropriate . . . but this is also the case before birth, when rights cannot be meaningfully applied to the embryo/fetus because it is not a fully individualized human being. the close bodily relationship of the woman to the fetus during pregnancy requires employing an ethics of care and responsibility.166 in contrast, if the progenitors are mutually interested in thawing or destroying the frozen embryo, or at least donating it for research, its ontology should be more akin to that of property, as we have seen in the jewish law’s conception in section 6. in brief, one can conclude that if the progenitors intend to implant the parental responsibility, hyper-parenting and the role of technology, in the oxford handbook of law, regulation and technology 404 (roger brownsword et al. eds., 2017). 163. see the following seminal research: john eekelaar, are parents morally obliged to care for their children?, 11 oxford j. l. stud. 340, 340 (1991); mavis maclean & john eekelaar, the parental obligation (1997); merle h. weiner, caregiver payments, and the obligation to give care or share, 59 vill. l. rev. 135, 135 (2014). 164. wiesemann, supra note 104, at 124. compare with onora o’neill, begetting, bearing, and rearing, in having children: philosophical and legal reflections on parenthood 25 (onora o’neill & w. ruddick eds., 1979); onora o’neill, the ‘good enough parent’ in the age of the new reproductive technologies, in the ethics of genetics in human procreation 33 (hille haker & deryck beyleveld eds., 2000). 165. see noddings supra note 52, 56 and accompanying text. 166. wiesemann, supra note 104, at 125. 2023] from (moral) status (of the frozen embryo) 297 embryo in the woman’s womb, it should be treated as a person and must not be thawed, but if the mutual agreement is not to use it, its ontology and moral status is not that of a person, and it can be destroyed. put differently, there is no point in bringing the embryo into existence when both of its potential intending parents are not interested in such non-caring relationships.167 therefore, a disposition agreement should be mandatory and should not be left to the discretion of the progenitors whether to enter it.168 moreover, in any case of an explicit mutual agreement either to use or destroy the frozen embryos, such a contract should be morally binding and legally enforceable. not only does it clearly reflect the initial intentions of the two parties whether to become the legal parents of the resulting child, but the notion of dlpba can be employed to determine the ontological status of the given frozen embryos considering relational ethics. the intrinsic contractual pitfalls of a change of heart or changed circumstances may find their appropriate answers in relational contract theory, which is also a byproduct, to some degree, of relational ethics. in any scenario where there is no explicit disposition agreement, or when the explicit contract has not stipulated what should be done with the frozen embryos under extreme exceptional circumstances, the party who is interested in using them should prevail. since this party is eager to become the parent of the resulting child, practically speaking, this party is treating the frozen embryo as a “human becoming,”169 the ontological status of which is akin to that of a person considering relational ethics. since bodily integrity and social relationships are deeply realized in legal parenthood, the latter should be considered in any ethical analysis regarding the moral status of frozen embryos.170 this individual invests 167. for a similar argumentation, see johnson, supra note 132, at 232 (“to tie these two separating individuals together over the life of a child to be born on the cusp of or after separation seems needlessly cruel for all concerned, including the prospective child. indeed, it seems like a recipe for a familial disaster.”). 168. for a similar conclusion, see eshre task force on ethics & law, the cryopreservation of human embryos, 16 hum. reprod. 1049, 1049 (2001). for my previous calls to obligate the progenitors to anchor in an explicit contract their initial agreement regarding the fate of their mutual genetic material, see margalit, supra note 133, at 386-88; margalit, determining legal parentage, supra note 106, at 254-57. see also in the context of surrogacy agreements, margalit, in defense of surrogacy agreements, supra note 106, at 466. for a similar call by another scholar, see malo, supra note 22, at 332, 334. 169. for a discussion of this phrase in the context of embryos, see lawrence c. becker, human being: the boundaries of the concept, 4 phil. & pub. aff. 334, 337 (1975); philip hefner, technology and human becoming (2003); berg, elephants and embryos, supra note 11, at 389. 170. wiesemann, supra note 104, at 117-18, at 123 (“thus, in order to define the moral status of the embryo we have to analyse the moral meaning of parenthood.”); see also jennifer nedelsky, property in potential life--a relational approach to choosing legal categories, 6 can. j. l. & juris. 343, passim (1993); jason scott robert & françoise baylis, crossing species boundaries, 3 am. j. bioethics 1, 4 (2003) (“in sum, even though biologists are able to identify a particular string of nucleotides as human (as distinct from, say, yeast or even chimpanzee), the unique identity 298 indiana health law review [vol. 20:257 in their present relationship with the frozen embryos and their forthcoming parent-child ongoing caring, interdependency, and committed relations. therefore, the law should recognize this “in-process” child-parent relationship by allocating rights and obligations to ensure that these present and future relations are upheld and maintained.171 this conclusion is the pillar of the arizona legislature’s recent shift to the presumption of giving the frozen embryos to the party who wants to bring one or more into the world.172 the reverse situation is that the party who is opposed to using the frozen embryos is not interested in bringing any child into the world. since that party is not interested in establishing present relations with the frozen embryo and, as a result, there will not be any mutual caring relations, that (non)existing relationship lacks any moral value. the legal system should not recognize that party as the legal parent of the resulting child, with all the attendant parental rights and obligations, and s/he should be free to find another caring relationship.173 for that recalcitrant progenitor, the moral status of the frozen embryo is merely as a good or article, like other properties; therefore, the balancing interests of the two progenitors should morally incline toward the side that awards them status akin to a person, and legally, this interest should prevail. consequently, since the relational approach dictates our parental rights and obligations as deriving from the relations and not from the mere biological legal status of frozen embryos, the party that is interested in obligating him/herself with caring, interdependency, and committed relations by bringing the resulting child into the world and raising it should be legally recognized as its legal parent to all intents and purposes. the party that is not interested in using the embryo and becoming a parent should not be defined as its legal parent and should not be burdened with any attendant obligations or awarded any rights. the foregoing relational approach lends great support to my compromise call published a decade ago.174 considering the human rights discourse, the author of the human species cannot be established through genetic or genomic means.”); kathleen hammond, relationally speaking: the implications of treating embryos as property in a canadian context, 32 can. j. fam. l. 323, 323 (2019). 171. see herring, the termination of pregnancy and the criminal law, supra note 68, at 145; herring, ethics of care, supra note 69, at 13; and more extensively herring, caring and the law, supra note 75, at 11-45. 172. ariz. rev. stat. ann. § 25-318.03(a) (2018) (inspired by terrell v. torres, no. cv-190106-pr, 2020 ariz. lexis 25 (jan. 23, 2020)). 173. see lois tonkin, haunted by a present absence, 4 stud. maternal 1, 1 (2012); herring, ethics of care, supra note 69, at 13-15 (“the law is not in the business of coercing relationships through threat of legal sanction, as that undermines the very goodness of a mutually respectful caring relationship.”); herring, the termination of pregnancy and the criminal law, supra note 68, at 147-51 (“the law’s response should be to facilitate the parties to escape from that relationship and to be free to form other relationships if they are able to.”). 174. for a further discussion of relational concerns/grounds regarding frozen embryos, see stephen r. munzer, an uneasy case against property rights in body parts, in property rights 259 (ellen frankel paul et al. eds., 1994) (arguing on relational grounds against a property right in 2023] from (moral) status (of the frozen embryo) 299 argues that the party who is opposed to continuing the fertilization would have to accept the status of non-parenthood, without any parental rights or obligations. in this way, the couple could arrive at an agreement that fertilization may continue without prejudicing the party opposed to the idea of forced parenthood, while giving the interested party the frozen embryos, enabling them to become the legal parent of the resulting child with all the consequent parental ramifications.175 the author in this article states: dispositions should be given full legal backing and should be enforced whenever necessary. even so, this compromise suggestion should be accompanied by legislation that would limit the inflexibility and the extent of the disputes that accompany such disagreements by providing the solution of granting non-legal parenthood to the subordinate spouse.176 to summarize, one suggested solution is to respect the initial agreement of the two progenitors, preferably anchored in an explicit mandatory disposition agreement. this agreement can indicate whether the frozen embryos should be used, donated to another couple, used for research, or destroyed. if there is no such mutual agreement, when the contract did not explicitly regulate such a disagreement, or when the contract is unenforceable, it should be interpreted in favor of the party who awards them status akin to a person by allocating parental status solely to them. the recalcitrant progenitor, who is not interested in using the frozen embryos and becoming a parent, should not be determined as its legal parent.177 iii. conclusion the already existing hundreds of thousands of unused frozen embryos, coupled with the skyrocketing rate of divorce, raise a myriad of moral, legal, human bodies and body products); judith d. fischer, misappropriation of human eggs and embryos and the tort of conversion: a relational view, 32 loy. la. l. rev. 381, 381 (1999). 175. margalit, supra note 133, at 389. see also margalit, determining legal parentage, supra note 106, at 242-43. 176. margalit, determining legal parentage, supra note 106, at 242; margalit, supra note 133, at 374. 177. such twofold regulation, giving the contract first place, and otherwise balancing the interests of the two parties, has been implemented in several verdicts, such as szafranski v. dunston, 34 n.e.3d 1132, 1132 (ill. app. ct. 2015) (“thus, we hold that a court should look first to any existing agreement expressing the spouses’ intent regarding disposition of the couple’s remaining pre-embryos in the event of divorce. in the absence of such an agreement, a court should seek to balance the parties’ respective interests [. . .]”); in re marriage of rooks, 429 p.3d 579, 579 (colo. 2018). for an academic discussion of it, see petralia, supra note 21; harman, supra note 2, at 544 ([a] possible application of the relation approach in this balancing test can be found in the following statement – “instead, courts should look more broadly and consider the interests of the progenitors, the ivf facility, and society at large when conducting the balancing test[.]”). 300 indiana health law review [vol. 20:257 social, and religious dilemmas. some of the most vexing problems are the moral and legal status of the frozen embryo and what its fate should be in case of disagreement between the progenitors, and whether contractual regulation of the frozen embryo is valid and enforceable. this article have enlisted relational ethics—inter alia through one of its contractual implementations, the relational contract—to resolve these intertwined problems. according to this theory, the status of the frozen embryo is primarily based on the present and future mutual relations of commitment, caring, and interdependency of the relevant individuals toward each other and the resulting child. on the grounds of the mutually desired or undesired caring relations between the two contracting parties, in any case of an explicit disposition agreement, the contract should govern. in any case of change of heart or changed circumstances in the de facto performance of the contract by both sides, the relational contract, which is a product of relational ethics, supplies us with adequate contractual solutions. in any scenario where there is no explicit disposition agreement or when the explicit agreement has not stipulated what should be done with the frozen embryos under extreme extraordinary circumstances, the author concludes that the party who is interested in using them should prevail. since the moral status of the frozen embryo is a direct byproduct of the caring and committed relationships of each progenitor toward it and toward the other party, only the one who treats it as a person by obligating him/herself to a lifetime of caring should be its legal parent. the other party, who treats it as a mere good or article, should not have any parental rights and obligations. legality of explicit racial discrimination in the distribution of lifesaving covid-19 treatments michael conklin* abstract in 2021, the federal drug administration released a statement advocating for race and ethnicity to be used in rationing lifesaving covid-19 treatments. by january 2022, three states had implemented policies explicitly prioritizing treatments based on race, which resulted in multiple legal challenges. this article analyzes the uphill battle such policies would face in an equal protection challenge. it also rebuts the attempt to analogize these policies to the legally acceptable practice of racial preferences in college admissions. finally, nonlegal, pragmatic consequences are considered, such as how the policy risks disproportionately favoring the wealthy reduces trust in future government pronouncements regarding covid-19, perpetuates harmful stereotypes about racial inferiority, breeds racial resentment, and causes unnecessary delays in treatment. the racially disparate outcomes from the covid-19 pandemic illuminate numerous background factors that disadvantage minority groups. however, the implementation of racial preferences in lifesaving treatments is not the answer. as demonstrated in this article, such policies spectacularly fail judicial scrutiny. furthermore, the nonlegal, pragmatic considerations establish that such a policy does far more harm than good. these considerations are of paramount importance not only for the current covid-19 crisis but also for future pandemics and the rationing of other limited medical resources, such as organ transplants and intensive care unit beds. i. introduction covid-19 has elicited a variety of issues regarding race and the law. when the vaccine was first made available, the centers for disease control and prevention (“cdc”) and various medical experts advocated for explicit racial preferences in distribution.1 heightened skepticism toward vaccination in the black and hispanic communities was linked to past racial discrimination in medicine, such as the tuskegee syphilis study.2 this vaccine skepticism results in disparate enrollment rates in covid-19 vaccine trials, which in turn results in more skepticism in the black community as to the safety of the vaccine for black * powell endowed professor of business law, angelo state university. 1. michael conklin, racial preferences in covid-19 vaccination: legal and practical implications, 5 how. hum. & c.r. l. rev. 141, 150-52 (2021). 2. dezimey kum, fueled by a history of mistreatment, black americans distrust the new covid-19 vaccines, time (dec. 28, 2020, 8:30 am), https://time.com/5925074/black-americanscovid-19-vaccine-distrust/ [https://perma.cc/9unw-d83b]. 316 indiana health law review [vol. 19:315 people.3 blacks and hispanics are more likely to have comorbidities that increase the risk of hospitalization and death from covid-19, such as obesity4 and chronic kidney disease.5 compounding the issue is that there are inequalities in access to nutritious foods6 and health care.7 early ventilator shortages were particularly significant in minority communities because the sequential organ failure assessment scale used to determine access to ventilators disadvantaged minority patients.8 new york city was criticized for prioritizing some races over others in distributing covid-19 tests.9 blacks and hispanics are more likely to work in the service industry, where they are more vulnerable to covid-19.10 blacks and hispanics are more likely to live in multigenerational homes, which increases the risk of covid-19 transmission.11 due to lower vaccination rates, vaccine mandates were criticized for disproportionately harming blacks and hispanics.12 race and gender preferences in president biden’s $1.9 trillion 3. ada stewart, minorities are underrepresented in clinical trials, am. acad. fam. physicians (dec. 4, 2018), https://www.aafp.org/news/ blogs/leadervoices/entry/20181204lvclinicaltrials.html [https://perma.cc/3gu7-w5wk]. 4. ruth peterson et al., racial and ethnic disparities in adult obesity in the united states: cdc’s tracking to inform state and local action, 16 preventing chronic disease e46, e46 (2019). 5. race, ethnicity, & kidney disease, nat’l kidney found., https://www.kidney.org/atoz/ content/minorities-kd [https://perma.cc/qft3-3rpj] (last visited jan. 21, 2022). 6. kelly brooks, research shows food deserts more abundant in minority neighborhoods, johns hopkins mag. (spring 2014), https://hub.jhu.edu/magazine/2014/spring/racial-food-deserts/ [https://perma.cc/d5jz-72sw]. 7. jesse c. baumgartner et al., inequities in health and health care in black and latinx/hispanic communities: 23 charts, commonwealth fund (june 3, 2021), https://www. commonwealthfund.org/publications/2021/jun/inequities-health-care-black-latinx-hispaniccommunities-23-charts [https://perma.cc/d89c-m3em]. 8. michael menconi, covid-19 ventilator allocation protocols are poised to disadvantage african americans, voices bioethics (may 30, 2020), https://journals.library. columbia.edu/index.php/bioethics/article/view/6210 [https://perma.cc/d5cr-wqq4]. 9. jon levine & conor skelding, nyc admits prioritizing race in distributing covid tests: leaked emails, n.y. post (jan. 1, 2022, 11:30 am), https://nypost.com/2022/01/01/nycadmits-to-prioritizing-race-in-distributing-covid-tests/ [https://perma.cc/7mq4-mtw2]. 10. lisa dubay et al., how risk of exposure to the coronavirus at work varies by race and ethnicity and how to protect the health and well-being of workers and their families, urban inst. (dec. 2020), https://www.urban.org/sites/default/files/publication/103278/how-risk-ofexposure-to-the-coronavirus-at-work-varies.pdf [https://perma.cc/4yal-d46a]. 11. april simpson et al., one home, many generations: states addressing covid risk among families, nbc news (mar. 27, 2021), https://www.nbcnews.com/news/latino/latinomultigenerational-households-risk-covid-states-address-vaccine-rcna511 [https://perma.cc/ftg4fdyc]. 12. jonathan tobin, vaccine mandates will have a disparate impact on minorities, newsweek (aug. 17, 2021, 7:00 am), https://www.newsweek.com/vaccine-mandates-will-havedisparate-impact-minorities-opinion-1619755 [https://perma.cc/5n6q-4zsu]. 2022] legality of explicit racial discrimination 317 american rescue plan act were enjoined by the sixth circuit court of appeals.13 the availability of highly effective covid-19 treatments in late 2021 introduced another legal race issue, namely, the constitutionality of rationing such life-saving treatments in a racially discriminatory manner. the federal drug administration (“fda”) released a statement explicitly advocating for race and ethnicity to be considered in administering covid-19 treatments.14 new york,15 utah,16 and minnesota17 implemented policies that explicitly discriminate on the basis of race in rationing covid-19 treatments. a number of people challenged the legality of these policies. senator marco rubio sent a letter to the fda referring to the policy as “racist and un-american.”18 former trump advisor stephen miller’s organization, america first legal, filed a lawsuit against new york, referring to the policy as “racist fascism.”19 cornell law professor william a. jacobson filed a class action lawsuit as the named plaintiff against the new york state department of health.20 this article analyzes the uphill battle such 13. see vitolo v. guzman, 999 f.3d 353 (6th cir. 2021). 14. alejandra o’connell-domenech, fda urges race, ethnicity be considered in covid19 drug treatment, hill (jan. 10, 2022), https://thehill.com/changing-america/well-being/ prevention-cures/589079-fda-urges-race-and-ethnicity-be-considered-in [https://perma.cc/p8c4ebn6]. 15. houston keene, new york says it will prioritize non-white people in distributing low supply of covid-19 treatments, fox news (dec. 31, 2021, 2:30 pm), https://www.foxnews. com/politics/new-york-prioritize-non-white-people-low-supply-of-covid-19-treatments [https://perma.cc/6jtx-83eq]. 16. simone seikaly, utah health officials on state’s covid risk score calculator: race/ethnicity isn’t automatic qualifier, ksl news radio (jan. 11, 2022, 8:21 pm), https:// kslnewsradio.com/1962481/utah-health-officials-on-states-covid-risk-score-calculator-raceethnicity-isnt-automatic-qualifier/ [https://perma.cc/2dln-gcn8]. 17. eugene volokh, minnesota government: “deprioritiz[e] access for patients” to covid drugs, based partly on their being white, reason (jan. 3, 2022, 12:25 am), https://reason.com/ volokh/2022/01/03/minnesota-government-deprioritize-access-for-patients-to-covid-drugs-basedpartly-on-their-being-white/ [https://perma.cc/2utu-v333] (minnesota has since removed the racial component in its latest draft); jeremy olson, minnesota removes race as factor in rationing covid-19 antibody treatment, star trib. (jan. 13, 2022, 12:27 pm), https://www. startribune.com/minnesota-removes-race-as-factor-in-rationing-covid-19-antibodies/600135503/ [https://perma.cc/826d-hw4m]. 18. press release, u.s. senator marco rubio, rubio to fda: un-american to ration lifesaving covid treatments based on race (jan. 11, 2022), https://www.rubio.senate.gov/ public/index.cfm/2022/1/rubio-to-fda-un-american-to-ration-life-saving-covid-treatments-based-onrace [https://perma.cc/jd9x-3csm]. 19. yael halon, former trump advisor suing new york state for racialized coronavirus priorities: ‘this is racist fascism,’ fox news (jan. 4, 2022, 10:31 pm), https://www.foxnews. com /m edia / s t eph en -m il le r -su in g -n e w -york-rac ia l ized-coron aviru s-pr ior i t ie s [https://perma.cc/v5h9-b93h]. 20. samuel kim, cornell law professor sues to stop state’s discriminatory therapeutic guidelines, cornell rev. (jan. 18, 2022), https://www.thecornellreview.org/cornell-law318 indiana health law review [vol. 19:315 policies would face in an equal protection challenge. it also rebuts any attempt to analogize the policy with the legally acceptable practice of racial preferences in college admissions. finally, pragmatic aspects are considered as to the wisdom of such policies. ii. the policies in the utah plan, points are awarded for 14 risk factors.21 vaccinated people must score 10 or more, and unvaccinated people must score 7.5 or more to qualify for treatment.22 the policy assigns twice as many points for being any race other than non-hispanic white than for high-risk comorbidities such as hypertension, congestive heart failure, and cardiac arrhythmia.23 and being of any race other than non-hispanic white is awarded the same points as being morbidly obese or severely immunocompromised.24 minnesota implemented a similar points system under which “bipoc status”25 is awarded two points which is the same amount awarded for someone 90 years old or morbidly obese.26 in the new york plan, patients are required to “have a medical condition or other factors that increase their risk for severe illness” to be eligible.27 anyone who is not a non-hispanic white person is automatically considered to meet this requirement.28 the lack of consistency among these plans may demonstrate the lack of scientific evidence that went into the formulas. for example, in minnesota chronic kidney disease is awarded three points, which is 50% more than one receives from being morbidly obese.29 but in the utah plan, chronic kidney disease is only awarded one point, which is 50% less than one receives from being morbidly obese. none of these policies create an absolute bar to non-hispanic whites receiving lifesaving covid-19 treatments. and the utah and minnesota policies do not automatically give treatments to someone based solely on his or her race.30 professor-sues-to-stop-state-therapeutic-guidelines/ [https://perma.cc/l6js-sbsg]. 21. seikaly, supra note 16. 22. id. 23. id. 24. id. 25. “bipoc” stands for “black, indigenous and other people of color.” volokh, supra note 17. 26. id. minnesota has since removed the racial component in its latest draft. olson, supra note 17. 27. keene, supra note 15. 28. id. 29. volokh, supra note 17. 30. the new york policy does give automatic treatment to everyone who is not a nonhispanic white, assuming they are at least 18 years old, test positive for covid-19, and are able to start treatment within five days of the onset of symptoms. see memorandum from the new york state dep’t of health to health care providers and health care facilities (dec. 27, 2021), 2022] legality of explicit racial discrimination 319 however, they each create racial hierarchies in which a non-hispanic white patient would be denied treatment, while a similarly situated minority patient would be given treatment. furthermore, the plans result in highly counterintuitive results given the stated purpose of rationing treatments to the most vulnerable. in new york, for example, a poor, non-hispanic white person aged 64 with no medical conditions would not be eligible for covid-19 treatments such as paxlovid and molnupiravir, while a healthy, rich, 24-year-old black person would,31 despite people aged 50-64 being 25 times more likely to die from covid-19 than people aged 18-29.32 and in minnesota, an 86-year-old nonhispanic white person with no medical conditions is the equivalent of an 18-yearold black person with no medical conditions for purposes of receiving covid19 treatments,33 despite an 86-year old being 370 times more likely to die from covid-19 than an 18 year old.34 iii. legality governmental policies that explicitly discriminate based on race must satisfy the strict scrutiny test.35 this test is so demanding that it is often referred to as “strict in theory, fatal in fact.”36 strict scrutiny applies even when race is only one of many factors considered, as is the case with the utah and minnesota policies.37 strict scrutiny requires the government to demonstrate that the discriminatory action addresses a compelling interest and is narrowly tailored to achieve that http://www.mssnyenews.org/wp-content/uploads/2021/12/122821_notification_107774.pdf [https://perma.cc/pb8r-bex7]. 31. john hirschauer, new york’s anti-white triage policy, am. conservative (jan. 12, 2022, 2:15 pm), https://www.theamericanconservative.com/state-of-the-union/new-yorks-antiwhite-triage-policy/ [https://perma.cc/e5rr-6w9d] (“[t]he new york department of public health confirmed that age is only considered a qualifying risk factor in new york for individuals aged 65 and older—meaning a white 64-year-old would not, on the basis of his age, be eligible to receive oral antiviral treatment for covid, while an otherwise-healthy 18-year-old haitian immigrant would.”). 32. risk for covid-19 infection, hospitalization, and death by age group, ctrs. disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigationsdiscovery/hospitalization-death-by-age.html [https://perma.cc/s4rj-efc3] (last updated mar. 9, 2022) [hereinafter risk for covid-19 infection]. 33. volokh, supra note 17. 34. risk for covid-19 infection, supra note 32. 35. richmond v. j.a. croson co., 488 u.s. 469, 493 (1989). 36. see, e.g., gerald gunther, foreword: in search of evolving doctrine on a changing court: a model for a newer equal protection, 86 harv. l. rev. 1, 8 (1972). however, some courts have explicitly rebuked this popular saying. see also, e.g., adarand constructors, inc. v. peña, 515 u.s. 200, 237 (1995) (“finally, we wish to dispel the notion that strict scrutiny is ‘strict in theory, but fatal in fact.’” (quoting fullilove v. klutznick, 448 u.s. 448, 519 (1980))). 37. fisher v. univ. of tex. at austin, 570 u.s. 297, 310-11 (2013). 320 indiana health law review [vol. 19:315 interest.38 claims as to the altruistic motives of the discrimination are irrelevant in strict scrutiny analysis.39 likewise, the direction in which the discrimination is applied is also irrelevant.40 meaning, strict scrutiny contains the same exacting rigor regardless of whether it discriminates against or in favor of a disadvantaged class.41 the policies in question here fail both the compelling governmental interest and the narrowly tailored prongs of the strict scrutiny test. governmental policies that discriminate on the basis of race are held to have a compelling interest in remedying past discrimination only when all three of the following criteria are met: 1) “[t]he policy must target a specific episode of past discrimination.”42 2) “[t]here must be evidence of intentional discrimination in the past . . . statistical disparities don’t cut it, although they may be used as evidence to establish intentional discrimination.”43 3) “[t]he government must have had a hand in the past discrimination it now seeks to remedy.”44 the state policies in question here fail all three criteria. the first criterion is not met because the three states do not identify specific incidents of past discrimination.”45 rather, they merely “point[] generally to societal discrimination.”46 the second element is not met because no evidence of intentional discrimination is provided. “[b]road statistical disparities cited by the government are not nearly enough.”47 finally, the third element is not met because no evidence is presented that the states of utah, minnesota, and new york had a hand in the past discrimination they now seek to remedy. the burden would be on the states to prove past discrimination rather than on a plaintiff to prove no past discrimination existed.48 and this is a high burden, requiring more than just isolated examples of past discrimination. for example, in a 1993 case involving an affirmative action plan in hiring female firefighters, a finding that 38. wygant v. jackson bd. of educ., 476 u.s. 267, 274 (1986). 39. johnson v. california, 543 u.s. 499, 505 (2005) (“we have insisted on strict scrutiny in every context, even for so-called ‘benign’ racial classifications, such as race-conscious university admissions policies, race-based preferences in government contracts, and race-based districting intended to improve minority representation.” (citations omitted)). 40. wygant, 476 u.s. at 271. 41. id. at 278 (“[t]he level of scrutiny does not change merely because the challenged classification operates against a group that historically has not been subject to governmental discrimination.”). 42. vitolo v. guzman, 999 f.3d 353, 361 (6th cir. 2021). 43. id. (citing richmond v. j.a. croson co, 488 u.s. 469, 503 (1989)). 44. vitolo, 999 f.3d at 361. 45. id. 46. id. 47. id. 48. brunet v. city of columbus, 1 f.3d 390, 405 (6th cir. 1993). 2022] legality of explicit racial discrimination 321 the city did not intentionally discriminate against women in the past was upheld despite the facts that prior to 1975 women were barred from the position, that only five in 832 firefighters were women, that the director of the training academy was biased against women, and that the city had previously refused to adopt testing methods less discriminatory against women.49 as one of the original thirteen colonies, it is no surprise that new york has a history of racist policies, including slavery.50 but to meet the strict scrutiny requirement, the past discrimination to be remedied must be direct and recent. courts have held that governmental policies as recent as fourteen to eighteen years ago were too old to qualify as justification for explicit preferences.51 at best, these states would be able to demonstrate that prior efforts to eliminate disparate health outcomes in the black and hispanic communities were unsuccessful. but such an argument fails because “[a]n observation that prior, race-neutral relief efforts failed to reach minorities is no evidence at all that the government enacted or administered those policies in a discriminatory way.”52 having established that these policies do not satisfy the compelling interest requirement, they are therefore unconstitutional without any further consideration necessary. however, the policies would also be held unconstitutional under the independent requirement that they be narrowly tailored. this requires that the government show “serious, good faith consideration of workable race-neutral alternatives.”53 a policy that discriminates on the basis of race cannot be upheld unless there is “no workable race-neutral alternative” that would achieve the compelling interest.54 here, not only do race-neutral alternatives exist, but they would be far superior to the racially discriminatory policies. this is because the current policies in question improperly double count race and comorbidities. being a person of black race does not, in itself, cause increased risk of death from covid-19.55 rather, it is the comorbidities, such as obesity and hypertension, that are disproportionately present in the black community that cause the increased risk.56 when factors such as age, sex, socioeconomic status, and 49. id. at 405-06. 50. history of slavery in new york, n.y. hist. soc’y, http://www.slaveryinnewyork.org/ history.htm [https://perma.cc/3hg8-kv8s] (last visited jan. 20, 2022). 51. see, e.g., brunet, 1 f.3d at 408-09 (citing examples of racial preferences that were allowed to remedy discrimination that occurred eight years before the preferences were instituted but not after fourteen years had passed); hammon v. barry, 826 f.2d 73, 76-77 (d.c. cir. 1987) (holding that a time period of eighteen years between the discriminatory conduct and the institution of the preferences was too remote). 52. vitolo, 999 f.3d at 362. 53. grutter v. bollinger, 539 u.s. 306, 339 (2003). 54. fisher v. univ. of tex. at austin, 570 u.s. 297, 312 (2013). 55. see baligh r. yehia et al., association of race with mortality among patients hospitalized with coronavirus disease 2019 (covid-19) at 92 us hospitals, 3 jama network open 1 (aug. 2020), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2769387 [https://perma.cc/2epf-fbbg]. 56. id. 322 indiana health law review [vol. 19:315 comorbidities are controlled for, hispanic and black patients with covid-19 have no greater risk of death than non-hispanic white patients with covid-19.57 therefore, by counting both the comorbidity and race as a factor increasing the odds of death, the same factor is essentially being counted twice, resulting in disproportionate significance. even setting aside the fatal issue of how the policies are not narrowly tailored because of the double counting issue, the policies are clearly not narrowly tailored because there are numerous race-neutral alternatives available. an incentive program could be implemented to increase vaccination rates, which could help narrow the gap in vaccination between minorities and non-hispanic whites. if it is determined that the reason blacks and hispanics are more likely to have comorbidities is a lack of access to medical care, then race-neutral programs to increase access to health care can be implemented. likewise, policies to increase access to nutritious foods can be implemented. innovative methods to deliver free covid tests, such as those implemented by the federal government in january 2022, could be used.58 and, perhaps most reasonably, racially neutral means testing that would more accurately distribute covid-19 treatments to the most vulnerable59 could be implemented. furthermore, a policy fails the narrowly tailored requirement if it is either overbroad or underinclusive.60 “when the government promulgates race-based policies, it must operate with a scalpel.”61 the three state policies in question are fatally overbroad because they include asians as minorities to receive preferential treatment in obtaining covid-19 treatments over non-hispanic whites.62 however, asian americans are less likely to test positive for, be hospitalized due to, and die from covid-19 than non-hispanic whites.63 this alone is enough to strike down the policies due to not being narrowly tailored.64 57. see rafi kabarriti et al., association of race and ethnicity with comorbidities and survival among patients with covid-19 at an urban medical center in new york, 3 jama network open 1 (sept. 2020), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/ 2770960 [https://perma.cc/6el4-26t5] (reporting the findings of a study that found non-hispanic whites have worse survival rates than both blacks and hispanics when relevant factors are controlled for). 58. mike winters, how to get free at-home covid-19 test kits mailed to your door, cnbc (jan. 18, 2022), https://www.cnbc.com/2022/01/18/how-to-get-free-at-home-covid-19-testkits-mailed-to-your-door.html [https://perma.cc/y28s-sjmd]. 59. see, e.g., supra notes 31-34 and accompanying text (demonstrating how a non-hispanic white person who is 25 times more likely to die from covid-19 than a black person is nevertheless deprioritized under the new york system). 60. see generally richmond v. j.a. croson co., 488 u.s. 469, 507-08 (1989). 61. vitolo v. guzman, 999 f.3d 353, 361 (6th cir. 2021). 62. see keene, supra note 15; see also seikaly, supra note 16; volokh, supra note 17. 63. risk for covid-19 infection, supra note 32. 64. see l. feriozzi concrete co. inc. v. casino reinvestment dev. auth., 776 a.2d 254 (n.j. super. ct. app. div. 2001) (“[t]he plan would still fail since the definitions of minorities are not narrowly tailored to survive a constitutional challenge.”). 2022] legality of explicit racial discrimination 323 the fact that the subject of this racial discrimination is lifesaving medicine in the middle of the deadliest u.s. pandemic in over 100 years also works to diminish any claim that these policies are narrowly tailored. this is because in considering if racial discrimination is narrowly tailored, courts are to consider “the impact of the relief on the rights of third parties.”65 some racial preference policies only result in being denied a promotion, not receiving government funds, or not being accepted into one’s first choice of college. but when the subject is lifesaving covid-19 treatments, the impact on third parties can include much more significant outcomes such as death. iv. affirmative action in college admissions analogy advocates for racial discrimination in covid-19 treatment are likely to attempt to compare the legally permissible practice of affirmative action in college admissions in an effort to support the legality of their position. indeed, supporters of racial preferences in vaccine distribution attempted to label the practice “a form of affirmative action of medical resources. . . .”66 and there are certainly similarities, such as how both involve a limited resource in which demand far exceeds supply. further analysis, however, demonstrates that this attempted comparison fails due to numerous significant differences. the supreme court has explained how higher education is a “unique contest” and more of an exception to the generally applicable standards for when racial preferences are allowed.67 affirmative action in higher education is even an outlier in the educational context, as the supreme court has struck down racial classifications in high school enrollment.68 while covid-19 treatments and college admissions both have demand that far exceeds supply, they have little else in common. while the benefits of covid-19 treatments are primarily incurred by the recipient, this is not the case with racial preferences in college admissions. there, the benefit is far more diffuse—to obtain “the educational benefits that flow from student body diversity.”69 therefore, even a student denied admission to an ivy league college because of his race nevertheless benefits from affirmative action because at whatever “lesser” college he ends up attending, he will benefit from the diverse student body, which is a product of affirmative action. but with covid-19 treatments, those denied access due to their race do not receive any benefit.70 to 65. united states v. paradise, 480 u.s. 149, 171 (1987). 66. hannah mclane, a disturbing medical consensus is growing: here’s what it could mean for black patients with coronavirus, pub. broad. serv. (apr. 10, 2020), https://whyy.org/ articles/a-disturbing-medical-consensus-is-growing-heres-what-it-could-mean-for-black-patientswith-coronavirus/ [https://perma.cc/8448-h8fk]. 67. parents involved in cmty. schs. v. seattle sch. dist. no. 1, 551 u.s. 701, 720 (2007). 68. id. 69. fisher v. univ. of tex., 136 s. ct. 2198, 2210 (2016). 70. the only exception would be possibly the psychic benefit one gains by knowing that there is an increased probability that the covid-19 treatment he was denied is more likely to go to a 324 indiana health law review [vol. 19:315 further illustrate the distinction, there is a stark difference between death from not receiving a lifesaving covid-19 treatment and not attending one’s first choice of college. attempting to analogize affirmative action in college admissions with racial preferences in covid-19 treatments is further problematic because the current makeup of the supreme court may no longer uphold the existing precedent regarding the former.71 chief justice roberts’s position on affirmative action in college admissions in parents involved in community schools v. seattle school district no. 172 is illustrative. he stated that “the way to stop discrimination on the basis of race is to stop discriminating on the basis of race.”73 one could easily imagine similar rhetoric applied to racial preference in covid19 treatments: “the way to stop treating people differently in medicine based on race is to stop treating people differently in medicine based on race.” v. pragmatism these state policies clearly fail the demanding legal requirements of strict scrutiny. but it is also worthwhile to consider the nonlegal pragmatism behind such a policy. such consideration illustrates that the unconstitutionality of such a practice is well justified, as it would result in far more harm than good. • it could result in de facto discrimination in favor of the wealthy. this is because the wealthy are able to finance research into their family histories to locate traces of minority ancestry, thus qualifying as minorities.74 • it could result in a lack of trust in future government pronouncements regarding covid-19. this is because people may view racial discrimination in the administration of lifesaving treatments as blatantly immoral and inefficient, thus calling into question more difficult decisions, such as mask mandates, quarantine timing, and shutdowns. even worse, this may evoke memories of past instances in which medical minority. of course, any such benefit could also be obtained by simply rejecting covid-19 treatments. 71. vinay harpalani, the supreme court and the future of affirmative action, am. const. soc’y (oct. 28, 2019), https://www.acslaw.org/expertforum/the-supreme-court-and-the-future-ofaffirmative-action/ [https://perma.cc/lc6x-hcsk] (explaining that, even before amy coney barrett replaced ruth bader ginsburg, justices john roberts, samuel alito, clarence thomas, neil gorsuch, and brett kavanaugh would likely vote to strike down affirmative action in college admissions as currently implemented). 72. parents involved in cmty. schs., 551 u.s. at 701. 73. id. at 748. significantly, justices scalia, thomas, and alito joined the part of chief justice roberts’s opinion in which this statement was made. 74. note that with some minority classifications, less than one-half of one percent heredity is required, such as with the cherokee tribe, which issues certificate degree of indian blood cards to anyone with at least 1/256 blood quantum. see also frequently asked questions, how much cherokee am i?, cherokee nation, https://www.cherokee.org/about-the-nation/frequently-askedquestions/miscellaneous/ [https://perma.cc/7uyl-gd85] (last visited jan. 21, 2022). 2022] legality of explicit racial discrimination 325 decisions were made based on race, such as the tuskegee syphilis study, which could result in further diminished trust in the government. • it could result in normalizing racial discrimination. if the federal government is encouraging it, and state governments are engaging in it, this sends an implicit message that the practice must not be that bad. and the act of engaging in racial discrimination could diminish the moral authority of these states to advocate against and prosecute other forms of racial discrimination. • treating black and hispanic races as a medical defect that is worse than congestive heart failure75 could perpetuate harmful notions of racial inferiority. • the policy could breed resentment against the groups receiving preferential treatment.76 it is easy to see how the family members of a poor, 64-year-old, non-hispanic white person who died because a lifesaving treatment was instead administered to a rich, 21-year-old, healthy, black person might allow such an occurrence to result in racial animosity. furthermore, such instances have proven to be powerful recruitment tools in the hands of white supremacist groups, where they are presented to support notions of martyrdom.77 • the policy could even result in negative perceptions of medical racism in the minds of those it seeks to benefit. the percentage of black people who believe race-based discrimination in health care happens very or somewhat often has been increasing. in 1999 the number was 56%, and in 2020 the number was 70%.78 • asking medical professionals to consider the race of their patients as a basis for treatment decisions is a dangerous precedent. this has been 75. in the utah policy, being black or hispanic is awarded twice as many points as having congestive heart failure. seikaly, supra note 16. 76. this would likely be similar to the link between affirmative action in college admissions and white resentment, except the severity of losing a loved one would likely exacerbate the potential for resentment. see, e.g., vann r. newkirk ii, the myth of reverse racism, atlantic (aug. 5, 2017), https://www.theatlantic.com/education/archive/2017/08/myth-of-reverse-racism/ 535689/ [https://perma.cc/bg6y-5uzl] (discussing “white resentment that’s surrounded the use of race in job and university application processes since the 1960s”). 77. olga khazan, how white supremacists use victimhood to recruit, atlantic (aug. 15, 2017), https://www.theatlantic.com/science/archive/2017/08/the-worlds-worst-supportgroup/536850/ [https://perma.cc/vms3-y6fb]. similarly, “men’s rights groups” could potentially use this policy to promote notions of male victimhood, since no preferences were given to men despite possessing significantly higher death rates from covid-19 than women. see ninh t. nguyen et al., male gender is a predictor of higher mortality in hospitalized adults with covid19, 16 pub. libr. sci. one 1 (2021), https://journals.plos.org/plosone/article?id=10.1371/journal. pone.0254066 [https://perma.cc/9gyq-mhxv]. 78. liz hamel et al., kff/the undefeated survey on race and health, kaiser fam. found. (oct. 13, 2020), https://www.kff.org/report-section/kff-the-undefeated-survey-on-race-and-healthmain-findings/ [https://perma.cc/5btx-eh49]. 326 indiana health law review [vol. 19:315 shown to result in suboptimal health diagnoses from stereotyping.79 • such a policy may even have the unintended consequence of decreasing medical treatment for black and hispanic people. this is because the very groups that are targeted—blacks and hispanics—could become skeptical as to why they are being prioritized for newly approved and/or experimental treatments. this is similar to how many in the black community expressed skepticism at the notion of prioritizing blacks for the covid-19 vaccine.80 • such a policy could be viewed as detrimental to racial progress by implicitly promoting the mindset that instead of treating root causes of disparate health outcomes, it is instead preferable to ameliorate the end result. this is exceedingly harmful because focusing on symptoms instead of root causes only perpetuates the status quo and keeps the chain of causation intact.81 • some may incorrectly interpret such a policy as evidence that races are not only different based on aggregate averages but also significantly different at the genetic level. this is a dangerous belief at the root of many white supremacist ideologies.82 there is even evidence of the prominence of this false belief among minorities. a 2020 study found that over 25% of black people believed that their worse health outcomes were the result of genetic differences.83 • the classification of race is far more subjective than most realize. it is ultimately an “arbitrary biological fiction,”84 and even dna evidence is 79. david e. bernstein, two decades ago, the fda and nih mandated the use of race to categorize subjects and report results in medical and scientific research they oversee. it was a huge mistake, yale j. on reg. (july 27, 2020), https://www.yalejreg.com/nc/two-decades-agothe-fda-and-nih-mandated-the-use-of-race-to-categorize-subjects-and-report-results-in-medical-andscientif ic-research-they-over see -i t -w as-a -h u ge-m is t ake-by-dav id-e -bern s t e in / [https://perma.cc/h5hw-n3fj]. 80. sigal samuel, should people of color get access to the covid-19 vaccine before others?, vox (oct. 28, 2020, 10:55 am), https://www.vox.com/future-perfect/2020/10/2/ 21493933/covid-19-vaccine-black-latino-priority-access [https://perma.cc/u9j7-cs6d] (statement of helene gayle) (“it’s not hard to imagine that if you put black and brown people first in the line, there’s going to be some real mistrust about whether or not people are being used as guinea pigs, because in the past they have been . . . [s]o i think it would probably be counterproductive.”). 81. see root cause analysis principles, tonex, https://www.tonex.com/root-cause-analysisprinciples/ [https://perma.cc/9ffb-9b52 ] (last visited jan. 21, 2022) (“the logic behind [root cause analysis] is that correcting or completely removing root causes, rather than addressing the surface symptom is the best way to solve the problems.”). 82. see amy harmon, geneticists criticize use of science by white nationalists to justify ‘racial purity,’ n.y. times (oct. 19, 2018), https://www.nytimes.com/2018/10/19/us/whitesupremacists-science-genetics.html [https://perma.cc/6gen-alay]. 83. hamel et al., supra note 78. 84. see ritchie witzig, the medicalization of race: scientific legitimization of a flawed social construct, 125 annals internal med. 675 (1996). 2022] legality of explicit racial discrimination 327 insufficient to make determinations.85 there is no universal standard for race classification; the same person can be classified as a different race depending on which governmental agency is making the determination.86 this reality leads some experts to posit that government racial classification judgments “should be dismissed out of hand if for no other reason than the government has no scientific or other reasonable basis for determining who qualifies as african american or hispanic/latino.”87 the inherent subjectivity of racial classifications, combined with the lifeor-death incentive of patients to lie about their racial backgrounds, is likely to be highly problematic. this added step of confirming racial identities could result in delays in treatment, when timing is of utmost importance and hospital staff are in short supply.88 • doctors who view their involvement in administering lifesaving medicine in a racially discriminatory manner as a violation of medical ethics would be put in a difficult position. this unnecessary conflict could result in suspended medical professionals at a time when they are needed the most. • finally, the litigation that was inevitably going to follow such a policy—and likely to be successful—is an argument against the pragmatism of implementing such a policy. vi. conclusion the racially disparate outcomes from the covid-19 pandemic shed light on numerous background factors that disadvantage some minority groups. however, the implementation of racial preferences in treatments is not the answer. as demonstrated in this article, distributing covid-19 treatment based on racial 85. see sarah zhang, a man says his dna test proves he’s black, and he’s suing, atlantic (sept. 19, 2018), https://www.theatlantic.com/science/archive/2018/09/dna-test-racelawsuit/570250/ [https://perma.cc/rk3g-gmyf] (“you cannot rely on dna evidence alone to decide what is really a socially constructed concept.”). 86. david e. bernstein, the modern american law of race, 94 so. cal. l. rev. 171, 173-74 (2021) (providing the example of mixed-race george zimmerman, who would be classified as different races depending on which entity is doing the classifying and also explaining how the same governmental agency will sometimes change its mind and revoke previously made racial determinations, such as in jana-rock construction, inc. v. new york state department of economic development, 438 f.3d 195 (2d cir. 2006)). 87. bernstein, supra note 79. 88. as new york city’s health commissioner dr. dave a. chokshi explains, “the science shows that monoclonal antibody treatments work and can make all the difference when it comes to the severity of covid-19 illness . . . . [t]reatment should be given as soon as possible after someone tests positive for covid-19 . . . .” press release, n.y.c. health dep’t, monoclonal antibody treatments save lives, health department reminds new yorkers (oct. 26, 2021), https://www1.nyc.gov/site/doh/about/press/pr2021/monoclonal-antibody-treatments-save-lives.page [https://perma.cc/vnq4-bc77]. 328 indiana health law review [vol. 19:315 preferences fails all three of the elements required to satisfy a compelling governmental interest, any one of which would be enough to render the entire policy unconstitutional. it also overwhelmingly fails the narrowly tailored requirement for multiple, independent reasons. furthermore, nonlegal, pragmatic considerations demonstrate that such a policy does far more harm than good. existing case law regarding the narrow application of when racial preferences are permissible and the current makeup of the supreme court result in the conclusion that the policies implemented in new york, utah, and minnesota are unlikely to stand up to judicial scrutiny. this article serves a valuable function by providing a better understanding of the legal and pragmatic considerations involved in such medical considerations of race. this is of paramount importance not only for the current covid-19 crisis but also for future pandemics and the rationing of other limited medical resources, such as organ transplants and intensive care unit beds. ihlr vol 14 iss. 2.pdf https://doi.org/10.1002/mar.20796 https://doi.org/10.1086/519499 https://doi.org/10.1371/journal.pone.0066428 https://doi.org/10.1371/journal.pone.0111629 exposure to complex environmental health challenges: agent orange and sodium dichromate cheryl g. sullivan* i. introduction american military personnel face danger not only from the weaponry of hostile forces but from exposure to occupational and environmental hazards as well. in two notable cases—exposure to agent orange during the vietnam war and sodium dichromate during operation iraqi freedom—american military leadership neither identified the risks nor diagnosed or treated the effects of such exposure. a sense of urgency exists to identify policy interventions by the public and private sectors to address the potential for future exposure of service members to environmental and occupational hazards given emerging threats.1 that exposure to agent orange and sodium dichromate was mishandled as a function of several readily identifiable factors. complexity theory2 can inform risk management3 of complex environmental * was the chief executive officer of the american academy of nursing (2010-2018), the deputy chief of staff for policy for senator evan bayh (2005-2010), and the cabinet secretary of the indiana family and social services administration (1993-1997 and 2003-2004). is a ph.d. candidate at indiana university, paul h. o’neill school of public and environmental affairs. email: cherylsull@aol.com, address: 5854 lawton loop west drive, indianapolis, indiana 46216. phone: (317) 331-9392 1. dep’t of defense, summary of the 2018 national defense strategy of the united states of america: sharpening the american military’s competitive edge 2-3 (2018) (cautions that “revisionist powers and rogue regimes are competing across all dimensions of power. they have increased efforts short of armed conflict by expanding coercion to new fronts, violating principles of sovereignty, exploiting ambiguity, and deliberately blurring the lines between civil and military goals.” further, “states are the principal actors on the global stage, but non-state actors also threaten the security environment with increasingly sophisticated capabilities. terrorists, trans-national criminal organizations, cyber hackers and other malicious non-state actors have transformed global affairs with increased capabilities of mass disruption”). 2. neil pearce & franco merletti, complexity, simplicity, and epidemiology, 35 int’l. j. epidemiology, 515, 518 (2006). “the key concepts of complexity theory are self-organization, adaptation, upheavals at the edge of chaos, the unpredictability of the effects of small changes in initial conditions, and the existence of simplicity at some levels while chaos exists at others.” 3. see dep’t of the army, army techniques publication no. 5-19: risk management, 1-1 (apr. 14, 2014), https://www.bits.de/nraneu/others/amd-us-archive/atp519c1%2814%29.pdf [https://perma.cc/e78r-ydem]. risk management is “the process of identifying, assessing, and controlling risks arising from operational factors and making decisions that balance risk cost with mission benefits.” see paul slovic, perceived risk, trust, and democracy. 13 risk analysis 675, 680 (1993). “we have a long way to go in improving our risk management processes. although we have expended massive amounts of time, money, and resources on scientific studies designed to identify and quantify risks, we have failed to expend the effort needed to learn how to manage the hazards that science is so good at identifying.” 154 indiana health law review [vol. 17:153 health challenges taking into account scientific uncertainty, politics, geographic environment, economic impact, and enacted statutes and legal decisions. first, the military is a complex adaptive system operating within an uncertain and complex environment. competing priorities among and for the benefit of numerous actors create challenges to enact policy change. some of the actors are soldiers who while deployed around the world have been exposed to hazardous chemicals of particular concern including agent orange and sodium dichromate. other actors, whose decisions in the management of environmental health risks of the soldiers are manifested in complex feedback loops, are the leadership in the military and federal agencies. these actors operate within continuously changing organizations, each with varying degrees of innovation, such as the individual branches of the armed forces; the u.s. departments of defense (dod) and veterans affairs (va); the congress; and the judiciary. second, risk management is not as easy as merely presenting risk assessment information and determining to accept the risk or not. the public’s perception of risk is viewed through the lens of their experience and association with known risks,4 is dependent on attitudes, beliefs, and values,5 and is interpreted through their knowledge of science.6 conflicts between risks we ask individuals to consider versus national aggregate risks we ask society to assume to avoid potential harm must be resolved.7 third, the expectation of scientific rigor in assessing risks to public health and the environment of military service members is limited by existing risk assessment methodologies.8 in addition, the legal definition of an adverse health effect is complicated by governing statutes passed by congress, regulations promulgated by federal agencies, and judicial decisions on litigation under tort or contract law.9 fourth, there exists a tension between the scientific process and the legal process. the nature of scientific inquiry is slow, evolves toward evidence, and carries a degree of uncertainty. the scientific process acknowledges that adverse effects are a constant at some level, and available resources impact risk management decisions. the legal system, on the other hand, “views the 4. vivianne h.m. visschers et al., how does the general public evaluate risk information? the impact of association and other risks, 23 risk analysis 715, 718 (2007). 5. lennart sjoberg, factors in risk perception, 20 risk analysis 1, 9 (2000). 6. elaine bratic arkin, translation of risk information for the public: message development, in effective risk communication: the role and responsibility of government and nongovernment organizations 127, 128 (vincent t. covello, david b. mccallum & maria t. pavlova eds., 1989). 7. dale hattis, scientific uncertainties and how they affect risk communication, in effective risk communication: the role and responsibility of government and nongovernment organizations 117, 125 (vincent t. covello, david b. mccallum & maria t. pavlova eds., 1989). 8. id. at 124. 9. nancy s. bryson, how science informs policy decisions: the legal definition of “adverse health effect”, 10 envtl. quality mgmt. 93, 93 (2001). 2020] exposure to complex environmental health challenges 155 expression of scientific uncertainty, even in small amounts, as cause for alarm and deconstruction.”10 with the presumption of innocence by industry, the high burden of proof that regulatory agencies must demonstrate delays and obstructs reasonable environmental health decision making. lastly, the management of uncertainty and conflict in the scientific basis of environmental health issues in the military is compounded by the unique characteristics of modern combat. the environmental risk assessment of a particular location in a war zone before the troop’s arrival just may not be feasible to conduct given the timing of the mission. strategies, as risk management options, are limited given the necessity to evaluate for both health and mission risks. epidemiologic assessments are hampered by the content of dod databases to identify service members with environmental exposures and the magnitude of exposure.11 the chain of command and the necessity for security create the unyielding presence of control among organizational dynamics. also, the prolific use of private contractors in theatre to undertake what historically has been federal government roles limit access to important and critical data. this article examines the application of complexity theory to the military environment in which servicemembers were exposed to agent orange in vietnam and sodium dichromate in iraq. using lessons learned from risk management responses, new perspectives on how federal administrators can prepare for and manage the next risk more effectively are presented. ii. systems framework drivers of emerging health threats to service members are complex and multilayered requiring not only interand transdisciplinary research but enhanced tools to examine the dynamic and adaptive processes of interconnected systems. “since the design, management, and control of complex adaptive systems can involve a challenging array of distributed and interacting agents, powerful feedback loops, large time delays, and counterintuitive system behavior, this may require innovative methodological strategies,” suggest ross hammond and laurette dubé.12 these strategies include the identification of the key system components, the drivers influencing the system components, and the linkages among systems including feedback loops.13 complexity theory research is a technique that purports to explain how 10. inst. med., environmental health sciences decision making: risk management, evidence, and ethics: workshop summary 32-33 (2009). 11. jean-paul chretien, katherine c. chretien & julie a. pavlin, long-term health consequences of military service: a proposal to strengthen surveillance and research, 131 pub. health reps. 834, 835 (2016). 12. ross hammond & laurette dubé, a systems science perspective and transdisciplinary models for food and nutrition security, 109 proc. nat’l acad. sci. 12,356, 12,357 (2012). 13. id. at 12,356. 156 indiana health law review [vol. 17:153 systems and organizations function.14 jeffrey goldstein, an editor launching the journal, emergence: complexity and organization (e:co) in 2004, claims that “complexity research has decidedly demonstrated that thriving organizations are better understood as complex[sic], nonlinear, far-from-equilibrium, and in vital contact with multiple environments.”15 organizations are no longer believed to be simple, linear, and independent systems tightly controlled to ensure stable environments.16 in their study linking complexity theory to core capabilities of continuously changing organizations, shona brown and kathleen eisenhardt concluded that “[c]ontinuously changing organizations are likely to be complex adaptive systems with semi-structures that poise the organization on the edge of order and chaos and links in time that force simultaneous attention and linkage among past, present, and future.”17 in other words, complexity theory posits that systems are evolving continuously, are characterized by “partial order, and lie between the extremes of very rigid and highly chaotic organization.”18 to solve complicated health policy problems, system science borrows its methodologies from the physical and biological sciences among other disciplines to understand and generate simplified models of the real world.19 system science attempts to understand the interaction of numerous components and relationships within an environmental context of uncertainty to address a range of assumptions leading to informed policy decisions.20 for example, using a childhood obesity interventions framework, terry huang et al. emphasized a “systems approach can be of particular value in connecting and synthesizing the disparate threads of prevention and intervention programs and in helping to identify strategies for intervention sustainability, scalability, and reach.”21 the systems-based framework acknowledges the complexity of “factors . . . to be studied together, incorporating linkages and feedbacks that cause changes in one area to be felt elsewhere in the system.”22 “modern societies are increasingly ruled by the unwanted side effects of their differentiated subsystems, such as the economy, 14. neil pearce & franco merletti. complexity, simplicity, and epidemiology. 35 int’l j. epidemiology 515, 515 (2006). 15. jeffrey goldstein, peter allen & david snowden. editors’ introduction, 6 emergence: complexity and org. v, v (2004). 16. id. 17. shona l. brown & kathleen m. eisenhardt, the art of continuous change: linking complexity theory and time-paced evolution in relentlessly shifting organizations, 42 admin. sci. q. 1, 32 (1997). 18. id. at 28. 19. patricia l. mabry, stephen e. marcus, pamela i. clark, scott j. leischow, and david mendez, systems science: a revolution in public health policy research 100 am. j. pub. health 1161, 1161 (2010). 20. id. at 1161-62. 21. terry t.k. huang, brandon grimm & ross a. hammond, a systems-based typological framework for understanding the sustainability, scalability, and reach of childhood obesity interventions 40 child. health care 253, 255 (2011). 22. id. at 254. 2020] exposure to complex environmental health challenges 157 politics, law, media, and science,” concludes julie thompson klein.23 “environmental problems exemplify the new relationship of interdisciplinarity and complexity.”24 whereas interdisciplinarity may address solving a problem that necessitates input from multiple disciplines, complexity examines nonlinear and system dynamics. applying complexity theory to the multiple systems of linked networks responsible for risk management of the service members exposed to agent orange and sodium dichromate, opportunities for consensus building,25 intervention, innovation, and adaptiveness can be identified. judith innes and david booher emphasize that “at the edge of chaos…innovation and dramatic shifts in activity patterns can occur, and systems can move to higher levels of performance. such innovation, however, depends on information flows through linked networks of agents.”26 identifying potential exposure to occupational and environmental hazards, the processes among federal agencies, the congress, and the judiciary can be refined to respond in a timely manner to health care needs of service members. iii. two complex cases: exposure to agent orange and sodium dichromate a. history the number of u.s. vietnam veterans exposed to agent orange is unknown.27 data obtained by the national academy of sciences (nas) indicates that in 2018, “va estimated that approximately 5,978,000 vietnam-era living veterans (deployed and non-deployed defined dates of service from august 1964 to april 1975) were living.”28 nas also reported that the results through 2000 of the vietnam experience study showed that “mortality among the deployed veterans was approximately 9% higher than among the non-deployed veterans.”29 although not likely all the approximately 2.6 million u.s. military personnel who served in vietnam were exposed to agent orange, the exact exposure 23. julie thompson klein, interdisciplinarity and complexity: an evolving relationship, 6 emergence: complexity and organization 2, 4 (2004). 24. id. at 5. klein recalls robert eisenstein’s characterization of “the shift in scientific research from the metaphor of a microscope to [that of] a kaleidoscope.” (emphasis omitted). 25. on how consensus building can be used for complex policy tasks, see judith e. innes & david e. booher, consensus building and complex adaptive systems, 65 am. planning ass’n j. 412, 413 (1999). 26. id. at 417. 27. u.s. gov’t accountability off., use of agent orange in vietnam (ced-78-158) 4 (1978), https://www.gao.gov/assets/130/123801.pdf [https://perma.cc/s5n3-5r8h]. 28. nat’l acad. sci. eng’r & med., veterans and agent orange: update 11 (2018) 26 (2018). 29. id. 158 indiana health law review [vol. 17:153 numbers cannot be determined.30 “army records from the vietnam conflict are neither complete nor well organized. this results from the army’s rapid pullout from vietnam.”31 during the conflict, the department of defense (dod) “did not consider the herbicide orange toxic or dangerous to humans” and “took few precautions to prevent exposure.”32 consistent with the army manuals describing herbicide orange as relatively nontoxic, “[p]ersonnel subject to splashes from handling the herbicide were instructed to shower and change clothes at a convenient opportunity.”33 under operation “ranch hand” between january 1962 and september 1971, approximately 20 million gallons of the herbicide agent orange were “stored, mixed, handled, and loaded into airplanes” by the u.s. air force to destroy 500,000 acres of crops and 5 million acres of forests in south vietnam.34 agent orange,35 stored in barrels with orange bands, was a formulation of 2,4dichlorophenoxyacetic acid (2,4,-d) and 2,4,5-trichlorophenoxyacetic acid (2,4,5-t); 2,4,5-t contained the contaminant 2,3,7,8-tetrachloro-p-dibenzo-dioxin or tcdd (commonly called “dioxin”).36 it now is known that dioxin because of its lipophilic character, is retained in human fatty tissue, is chemically stable, and is slow to metabolize.37 tcdd impacts complex cellular actions including binding of tcdd to the aromatic hydrocarbon (ah) receptor that is an activator for gene transcription.38 in humans, the half-life of dioxin is “estimated to vary from 0.4 to more than 10 years.”39 the international agency for research on cancer (iarc) classified 2,3,7,8tcdd as a group 1, “known human carcinogen” in 1997; the u.s. toxicology program revised its classification based on new molecular and cellular information from “reasonably anticipated to be a human carcinogen” to “known 30. id. at 25-26. 31. u.s. gov’t accountability office, report by the comptroller general of the united states: u.s. ground troops in south vietnam were in areas sprayed with herbicide orange (1979). 32. id. at 1. 33. id. at 4. 34. u.s.-vietnam dialogue group on agent orange/dioxin 2010-2019, declaration and plan of action: addressing the legacy of agent orange in vietnam 4 (2010), https://assets.aspeninstitute.org/content/uploads/files/content/docs/advocacy%20and%20exchan ge%20program%20on%20agent%20orange/2010-6-16usvietnamdialoguegroup declarationandplanofaction.pdf [https://perma.cc/qc7g-u6uy]. 35. civilian application of herbicide orange was diluted and utilized at one to four pounds per acre; the military application of 107 million pounds over six million acres was undiluted and sprayed at 12 pounds of 2,4-d and 13.8 pounds of 2,4,5-t per acre. see u.s. gov’t accountability office, supra note 27, at 2. 36. nat’l acad. sci. eng’r & med., supra note 28, at 27. 37. nat’l toxicology program, 12th report on carcinogens 396-97 (2011). 38. id. 39. nat’l acad. sci. eng’r & med., supra note 28, at 71. 2020] exposure to complex environmental health challenges 159 to be a human carcinogen,” in 2001; and reaffirmed “no known ‘safe dose’ or ‘threshold’ below which dioxin will not cause cancer” in 2003.40 in 1978, congressman ralph metcalfe investigated the handling of herbicide exposure disability claims from vietnam veterans and expressed concern to the u.s. government accounting office (gao) on possible long-range adverse health effects.41 in the response to metcalfe, the gao comptroller noted dod’s rigid stance, “defense officials believe that no firm link has been made between long-term adverse health effects and exposure to herbicides in vietnam.”42 dod was undeterred even though in 1974, the national academy of sciences concluded, “[f]urther intensive studies are especially required with reference to the ecological distribution, the pharmacology mechanism of toxicity, possible mutagenicity, and carcinogenicity of tcdd and its possible teratogenicity in man.”43 one year later after senator charles percy expressed concern on behalf of senate permanent subcommittee on investigations, comptroller general admitted, “the department of defense (dod) did not consider herbicide orange toxic or dangerous to humans and took few precautions to prevent exposure to it.”44 the comptroller general recommended “the need to resolve veterans’ concerns over the alleged health risks attributed to herbicides.”45 in testing the remaining stocks of agent orange in 1971, tcdd contaminant levels were ranging “from less than 0.05 to 47 parts per million and averaging about 2 parts per million. current (1978) manufacturing standards for 2,4,5-t,” the gao said, “require tcdd levels be less than 0.1 part per million.”46 later in 1978, a class-action lawsuit was filed on behalf of vietnam veterans led by a helicopter crew chief, paul reutershan, who believed his abdominal cancer was caused by exposure to agent orange during operation “ranch hand.”47 the u.s. veterans administration now recognizes seven cancers including chronic b-cell leukemia, multiple myeloma, and hodgkin’s disease and seven other illnesses including chloracne and parkinson’s to provide presumptive eligibility for disability compensation for veterans who served in the republic 40. nat’l toxicology program, supra note 37, at 396. dioxins & furans: the most toxic chemicals known to science, energy just. network, http://www.ejnet.org/dioxin/ [https://perma.cc/t5rw-6ctd]. 41. u.s. gov’t accountability off., supra note 31, at 1. 42. u.s. gov’t accountability off., supra note 27, at 5. 43. id. 44. u.s. gov’t accountability office, supra note 31, at 1. 45. id. at 9. 46. u.s. general accounting office, supra note 27, at 3. 47. richard severo, vietnam veteran’s family vows to continue his fight, n. y. times, (dec. 19, 1978), https://www.nytimes.com/1978/12/19/archives/vietnam-veterans-family-vows-tocontinue-his-fight-friends-pledge.html [https://perma.cc/y6r6-bkkl]. clifford terry, shameful story told in ‘causes’ chicago tribune (nov. 10, 1986), https://www.chicagotribune.com/ news/ct-xpm-1986-11-10-8603250025-story.html [https://perma.cc/z462-k248]. 160 indiana health law review [vol. 17:153 of vietnam.48 more than thirty years later, at the qarmat ali water treatment plant in basra, iraq, in 2003, deployed service members provided escort and security to employees of brown and root services, a division of kellogg, brown and root (kbr). kbr was under contract to restore the plant to operative status.49 approximately 830 service members, many from oregon, west virginia, south carolina, and indiana national guard units50 potentially were exposed to sodium dichromate, a corrosion inhibitor in water.51 sodium dichromate is an inorganic compound containing hexavalent chromium (chromium vi) known to be toxic and carcinogenic to humans.52 the route of exposure of hexavalent chromium (na2cr2o7), the toxic component of sodium dichromate, is by inhalation, ingestion, or broken skin, and is readily absorbed into cells.53 only a tiny amount of hexavalent chromium poses a serious risk.54 max costa, chair, department of environmental medicine, at new york university school of medicine, testified that translating epa’s acceptable cancer risk of one cancer in one million people would limit exposure to hexavalent chromium at merely 80 picograms per cubic meter or 8 x 10-5 ug per cubic meter, “so small that one could not begin to see it with the human eye.”55 similar to the dod’s initial response to the armed forces’ exposure to agent orange, ellen embry, the u.s. deputy assistant secretary of defense, force health protection and readiness, testified in 2007 before congress to the possible exposure of the then-estimated 250 service members to sodium dichromate and polychlorinated biphenyls stating that “no specific abnormalities attributable to possible exposures were identified, and no long-term health effects are expected.”56 48. diseases related to agent orange, u.s. dep’t veterans affs., https://www.va.gov/ disability/eligibility/hazardous-materials-exposure/agen t-orange/related-diseases/ [https://perma.cc/5l79-4bda]. 49. inspector gen., u.s. dep’t def., exposure to sodium dichromate at qarmat ali iraq in 2003: part ii—evaluation of army and contractor actions related to hazardous industrial exposure, report no. spo-2011-009 1 (2011). 50. 152nd infantry battalion, indiana army national guard 51. qarmat ali water treatment facility, u.s. dep’t veterans affs., https://www. publichealth.va.gov/exposures/qarmat-ali/ [https://perma.cc/5pqp-ugyk]. 52. memorandum from defense health board, to ltg eric b. schoomaker, surgeon gen., army, on defense health board review of the u.s. army center for health promotion and preventive medicine assessment of sodium dichromate exposure at qarmat ali water treatment plant, 2 (dec. 19, 2008). 53. id. 54. the exposure at qarmat ali: contractor misconduct and the safety of u.s. troops in iraq: hearing before the s. democratic policy comm., 110th cong. 3 (2008) (statement of max costa, professor and chairman, dep’t of envtl. medicine, n. y. univ. school of med.). 55. id. 56. statement before the h. subcomm. on def. appropriations, 110th cong. 15 (2007) (statement of ellen embry, deputy assistant secretary of defense, force health protection and 2020] exposure to complex environmental health challenges 161 a soldier reported “there was a coating of orange-colored powder throughout the facility. at times, it was so thick there were at least two inches of powder on my boots.”57 edward blacke, former kbr health, safety and environmental coordinator in qarmat ali, testified in 2008 that he observed, “continuous bloody noses, spitting up of blood, coughing, irritation of the nose, eyes, throat and lungs, and shortness of breath.”58 by 2011, the dod had estimated that “nearly 1000 soldiers and u.s. army civilian employees were exposed to sodium dichromate in the five months it took from the initial site visit until the military command required personal protective equipment.”59 the inspector general for the dod concluded that “kbr did not fully comply with applicable occupational safety and health standards, and tf rio [task force restore iraqi oil]60 failed to enforce contractor compliance.”61 and, litigation was pending by approximately 150 service members against kbr and others; the medical costs for those exposed are unknown.62 iv. risk management a. general considerations institutional rules for risk management processes are grounded in statutory authority, regulatory authority, and judicial decisions. to address uncertainty, these rules change over time, change across public health threats, and are not stable.63 the degree of uncertainty to reduce, the upper bounds of probability scenarios to test, the technical facts to research, and the process of communicating results are left to the policymakers. to reduce uncertainties, policymakers are put in the untenable position of often prioritizing risk assessments to be conducted on hazards with known effects but relatively low impact or on hazards with unknown effects but potentially high impact. it is important to note that risk communication is essential even if the scientific data readiness, department of defense). 57. the exposure at qarmat ali: did the army fail to protect u.s. soldiers serving in iraq?: hearing before the s. democratic policy comm., 111th cong. 1 (2009) (statement of russell powell, former staff sergeant, west virginia army national guard). 58. the exposure at qarmat ali: contractor misconduct and the safety of u.s. troops in iraq: hearing before the s. democratic policy comm., 110th cong. 2 (2008) (statement of edwards blacke, former kbr employee). 59. inspector gen., u.s. dep’t def., supra note 49, at 5-6. 60. the task force restore iraqi oil (tf rio) program was to restore iraq’s oil industry infrastructure. the u.s. corps of engineers (usace ) was assigned the mission. usace awarded kbr contract daca63-03-d-0005. id. at 1. 61. id. at 12. 62. id. at 11. 63. “uncertainty is the imperfection in knowledge of the true value of a parameter for either an individual or a group.” inst. med., supra note 10, at 25. 162 indiana health law review [vol. 17:153 is incomplete or alarming. covello, sandman, and slovic underscore that “in science there is never complete certainty, since new evidence can always overturn previous beliefs.”64 federal administrators need the flexibility in order to act swiftly in coordinated fashion particularly in times of national emergency under the leadership of a designated agency and agent but without compromising processes for human safety, public health, fiscal responsibility, or national security. this, in turn, requires transparency as to the risks of chemicals, data produced by manufacturers on a product’s effect on health and the environment, the scientific protocols followed at every stage, the environmental assessments conducted, and the manufacturer’s responsibility for hazards. b. military decisions of the armed forces are dependent on their specific mission; orders are delivered from the hierarchical top-level brass. control is rigid and localized in a war theatre. actors whose decisions in the management of environmental health risks manifest in complex feedback loops are the leadership in the federal agencies namely the u.s. departments of defense and veterans affairs, congress, the judiciary. these actors traditionally manage risks within a unit system and closely follow fluctuations of information inputs; creative solutions are limited by real and assumed boundaries. modern warfare operations include armed forces from multiple nations and civilian contractors who may contribute to a chaotic environment by exercising their separate control and command responsibilities. given a crisis, multiple rigid organizational structures and stakeholders within the u.s. government and outside each with their own policies, procedures, and techniques for risk assessment and incentives for risk management contribute to the range of unpredictable behaviors of the disparate actors. these organizational structures require simultaneous attention and chaos may be observed at the system level. there were risk management processes in place when service members were exposed to agent orange and sodium dichromate. however, the processes were neither robust nor effective for the toxicity of the agents to which the members of the armed forces were exposed nor for the environment in which the armed forces were operating.65 the concerns raised by members of congress to the handling of disability claims, the filing of the class-action lawsuit claiming cancers and birth defects were caused by agent orange,66 and the notification to 64. vincent t. covello, peter m. sandman & paul slovic, risk communication, risk statistics, and risk comparisons: a manual for plant managers: part v anticipating objections to explanations of chemical risks (1988). 65. u.s. gov’t accountability office, supra note 31, at 9. 66. the class consisted of those persons who were in the united states, new zealand or australian armed forces at any time from 1961 to 1972 who were injured while in or near vietnam by exposure to agent orange or other phenoxy herbicides, including those composed in whole or in part of 2,4,5–trichlorophenoxyacetic acid or containing some amount of 2020] exposure to complex environmental health challenges 163 the coalition joint task force 7 about the exposure to sodium dichromate acted as catalysts or drivers in the unstable environments prompting the retooling of risk management processes. the u.s. army public health command released the 2013 revision of the environmental health risk assessment and chemical exposure guidelines for deployed military personnel to “characterize operational risks from chemical exposures as consistently as possible, by use of a standardized process that is both scientifically supportable and militarily feasible.”67 these guidelines include a range of deployment scenarios from a single catastrophic release of a chemical to a temporary exposure to a continuous environmental exposure in air, water, or soil. similarly, the exposures may be intermittent, continuous, or simultaneous.68 chemical exposure guidelines for deployed military personnel are issued to provide military exposure guidelines (megs) to characterize health and mission risks in a deployment environment to chemical warfare agents (cwas) and toxic industrial chemicals (tics).69 risk management decisions based on the (megs) are unique to the military population as chemical exposure data must be evaluated for both health and mission risks; the guidelines are a tool for a commander to use for operational decisions.70 megs developed by the u.s. army public health command were adapted from existing federal standards, including that of the u.s. environmental protection agency (usepa) and the agency for toxic substances and disease registry (atsdr), and peer-reviewed toxicological estimates among others.71 certain assumptions are made namely that the military population including active duty, reserve, and national guard, is “healthy and fit.”72 although the guidelines assume no predisposing factors, the usaphc acknowledges that “with increased reliance on national guard and reservists, an increased number of older personnel are now deployed” and there may be individuals who are susceptible to chemical exposures.73 acknowledging genetic variability and individual susceptibility is essential.74 the megs represent conservative population thresholds and a single exposure rather than cumulative 2,3,7,8–tetrachlorodibenzo-p-dioxin. the class also includes spouses, parents, and children of the veterans born before january 1, 1984, directly or derivatively injured as a result of the exposure. in re “agent orange” prod. liab. litig., 100 f.r.d. 718, 729 (e.d.n.y. 1983) (certifying class). 67. u.s. army pub. health command, environmental health risk assessment and chemical exposure guidelines for deployed military personnel 2 (2013), https://phc.amedd.army.mil/phc%20resource%20library/tg230-deploymentehra-and-megs2013-revision.pdf [https://perma.cc/3cy2-5ywj].. 68. id. at 4. 69. id. at 22-23. 70. id. at 4, 21. 71. id. at 10. 72. id. at 6, 17. 73. id. at 17. 74. id. 164 indiana health law review [vol. 17:153 effects of multiple deployments.75 c. response to agent orange exposure the behavior of the military as an organization in its risk management efforts of agent orange was disjointed, haphazard, and uncoordinated.76 not addressing the toxicity of the herbicide when deciding to utilize it for defoliation efforts as part of its mission, lack of record-keeping, controversy over data reliability of the evidence linking health risks to the exposure, and the confusion over responsibility for managing the risk were disastrous. indeed, in response to questions, richard danzig, principal deputy assistant secretary of dod, in september 1979, said, “[e]ven today, there is no valid scientific evidence to support a causal relationship between low dosage exposure and unspecific human diseases of delayed onset.”77 gao cited army manuals that “described herbicide orange as ‘relatively nontoxic to man or animals.’”78 although mission requests were approved by the military chain of command and the south vietnamese government, “most helicopter missions and all truck, boat, and hand spraying were conducted at the discretion of unit commanders.”79 the chain of military command, the u.s. embassy officials, members of the south vietnamese government, the airmen in helicopters, and the soldiers on the ground were actors each operating in rigid control within their own leadership command yet together were contributing to the chaotic dynamics of a war environment.80 science now shows that variables influencing the degree of exposure include the rate of biodegradation of herbicide orange, the drift of the sprayings from the targeted areas, and ground troop locations.81 containment of the drift of herbicide orange influenced by climate as well as the speed and altitude of the aircraft was determined only after examination of widespread crop damage extending from one-two kilometers.82 given the belief that herbicide orange was “relatively nontoxic to man or animals,” no special safety precautions were taken to avoid exposure outside of air force handlers being advised to use gloves and face shields.83 the time period dod advised between spraying and defoliation was four to six weeks to ensure successful defoliation and safety of ground troops, not to protect service members from toxic exposure, but rather from gunfire from 75. id. at 18. 76. u.s. gov’t accountability office, supra note 31, at 5. 77. letter richard danzig, principal deputy assistant sec’y of def, to william j. mccormick, jr., ass. dir., fed. personnel and compensation div., u.s. gen. accounting office 2 (sept. 4, 1979). 78. u.s. gov’t accountability office, supra note 31, at 4. 79. id. 80. id. 81. id. at 6. 82. id. at 6-7. 83. id. at 4. 2020] exposure to complex environmental health challenges 165 fighter surveillance aircrafts.84 even with dod’s guidance, however, “chemical officers confirmed that no restrictions [actually] were placed on entering sprayed areas.”85 indeed, contrary to the dod maintaining that “exposure was very unlikely since dod personnel did not enter a sprayed area until approximately 4 to 6 weeks after the mission when defoliation was complete,” a time span of six weeks, the gao investigation revealed that troop commanders merely “were asked to keep troops clear of the area during the spraying mission.”86 numerous federal agencies shared responsibility for the oversight and risk of the exposure effects of tcdd. the agent orange working group designated in 1981 by the white house included the dod, va, health education and welfare (hew), agriculture and epa.87 in addition, the departments of agriculture, interior, and hew exercised their authority in april 1970, to suspend certain uses of 2,4,5-t in most herbicide applications recognizing that 2,4,5-t was a teratogen.88 each of these agencies, however, operated independently with their own leadership, unique statutorily mandated missions, and separate appropriated federal budgets, thereby creating an environment of frustration on the edge of chaos with little evidence of information feedback among the agencies to adapt to change nimbly. as early as 1970, congress mandated the dod to seek the national academy of sciences (nas) to study the ecological and physiological effects of the use of herbicides in south vietnam.89 the nas recommended in 1974 that “further intensive studies are especially required with reference to the ecological distribution, the pharmacology mechanism of toxicity, possible mutagenicity, and carcinogenicity of tcdd and its possible teratogenicity in man.”90 despite the national academy of science’s recommendation for a long-term study, not only did the department of defense determine that no epidemiological study would be undertaken,91 they did not issue “any instructions to its medical facilities to monitor complaints of illness possibly resulting from herbicide exposure.”92 in fact, there were no accurate dod military records of service members’ deployment locations that would establish proximity to health risk. finally, in 1978, the va began compiling an agent orange registry by offering medical 84. id. at 5. 85. id. 86. id. at 4-5. 87. agent orange review (veterans admin., d.c.), aug. 1983, at 1, https://www. publichealth.va.gov/docs/agentorange/reviews/ao_newsletter_aug83.pdf [https://perma.cc/9el7hcrt]. 88. u.s. dep’t veterans affs., vietnam veterans and agent orange exposure: independent study course, 3 (2002), https://stlawco.org/data/files/departments/veterans/ agentorangedata/vhiagentorange.pdf [https://perma.cc/3kx3-2pkz]. 89. act of oct. 7, 1970, pub. l. no. 91-441, 84 stat. 905, 913 (1970). 90. u.s. gov’t accountability office, supra note 27, at 5. 91. id. at 2. 92. id. at 6. 166 indiana health law review [vol. 17:153 exams to those who may have been exposed. through september 2018, 690,302 initial exams and 81,926 follow up exams had been provided.93 the agent orange class-action lawsuit filed in 1979 on behalf of service members injured by exposure to agent orange and their families sought relief through the judicial system against the major manufacturers of herbicides used in the vietnam war after the victims had been neither recognized nor compensated for their injuries by the military or va.94 a $180 million out of court settlement was settled in 1984.95 nine years after the payment program was initiated, the fund was depleted; approximately 52,000 veterans received cash payments averaging about $3,800.96 in 2003, the u.s. supreme court failed to broaden the settlement with a deadlocked vote.97 the result of this lawsuit was as a catalyst for congress to enact legislation authorizing the va to conduct an epidemiological study, for the white house to establish the interagency work group to study possible long-term health effects of phenoxy herbicides, and the va to establish the advisory committee on health-related effects of herbicides.98 93. bill outlaw, calling all vietnam veterans: it's to your benefit to join the agent orange registry, u.s. dep’t veterans affs., https://www.publichealth.va.gov/exposures/publications/ agent-orange/agent-orange-2018/ao-registry.asp [https://perma.cc/7nsh-dmw2]. 94. see in re “agent orange” prod. liab. litig., 818 f.2d 145, 148-152 (2d cir. 1987) (providing history of the litigation), aff’d 597 f. supp. 740 (s.d.n.y. 1984) (approving settlement between plaintiffs and chemical companies). see also in re “agent orange” prod. liab. litig., supra note 66. (certifying the class, which consisted of those persons who were in the united states, new zealand or australian armed forces at any time from 1961 to 1972 who were injured while in or near vietnam by exposure to agent orange or other phenoxy herbicides, including those composed in whole or in part of 2,4,5–trichlorophenoxyacetic acid or containing some amount of 2,3,7,8–tetrachlorodibenzo-p-dioxin. the class also includes spouses, parents, and children of the veterans born before january 1, 1984, directly or derivatively injured as a result of the exposure). 95. agent orange settlement fund, u.s. dep’t veterans affs., https://www.benefits.va. gov/compensation/claims-postservice-agent_orange-settlement-sett lementfund.asp [https://perma.cc/tg97-l9st]. in re “agent orange” prod. liab. litig., 597 f. supp. 740, 748 (e.d.n.y. 1984).“pursuant to the stipulation of settlement, defendants have agreed to pay to the class $180 million plus interest.” 96. id. 97. although justice john paul stevens recused himself without reason, it was reported that his son with cancer died in 1996, at 46 years. gina holland, court deadlocks on agent orange, cbs news (jan. 9, 2003), https://www.cbsnews.com/news/court-deadlocks-on-agent-orange/ [https://perma.cc/96ur-zudp]. 98. the veterans health programs extension and improvement act, p.l. 96-151, 93 stat. 1092; agent orange review, supra note 87, at 1. (the interagency work group consisted of hhs (lead agency); white house office of policy development; white house office of science and technology policy; office of management and budget; council of economic advisors; epa; departments of state, agriculture, labor, veterans administration, and action); dep’t of veterans affairs, vietnam veterans and agent orange exposure: independent study course 1, 2 (2002), https://www.stlawco.org/data/files/departments/veterans/agentorangedata/ 2020] exposure to complex environmental health challenges 167 this epidemiological study and workgroup were not successful. the government did not intend to include ground troops in their study of long-term medical effects linking only herbicide handlers and aircraft crewmembers to exposure, remarkably, even though the dod acknowledged ground troops’ exposure.99 the va failed in its efforts to design the research protocol on the long term effects of dioxin; cdc was transferred the responsibility for leading the study.100 and, the cdc was burdened with its own challenges in acquiring exposure data from military records and self-reports. while an agent orange validation study was attempted, cdc found the military records lacking to conduct the large epidemiologic study.101 cdc efforts were halted after advisory boards and panels concluded, “the congressionally mandated agent orange study was improbable.”102 responsiveness to service members with policy changes that could address and support their health care needs was delayed by uncertainty. attentiveness to symptoms of a disease to confirm a service-connected disability was delayed by the absence of documentation linking proximity to the chemical agent103 and science demonstrating causal effect between exposure and disease.104 “epidemiologic studies on agent orange are historically burdened by the lack of reliable exposure data. the lack of accurate data remains a continued source of frustration for researchers, government officials, and vietnam-era veterans seeking conclusive information on the health risks of exposure to agent orange.”105 vhiagentorange.pdf [https://perma.cc/38dd-8zlq]. 99. comptroller general of the united states. u.s. ground troops in south vietnam were in areas sprayed with herbicide orange. letter from comptroller general of the u.s. elmer b. staats, to senator charles percy, permanent subcommittee on investigations, committee on governmental affairs. fpcd-80-23, november 16, 1979, at 9. 100. sidath viranga panangala,, cong. research serv., rl34370, veterans affairs: health care and benefits for veterans exposed to agent orange 6 (2008). 101. id. 102. id. at 10. 103. u.s. gov’t accountability off., fpcd-80-23, u.s. ground troops in south vietnam were in areas sprayed with herbicide orange 1 (1979). 104. see nat’l acads. of scis eng’g & med, veterans and agent orange: update 11 12-14 (2018). “there are many questions regarding veterans’ health that cannot be adequately answered by examining superficially analogous exposures and outcomes in other populations. it is only through research on veterans themselves that the totality of the military service experience can be properly accounted for.” id. at 15. see also inst. of med., comm. on the assessment of wartime exposure to herbicides in viet., characterizing exposure of veterans to agent orange and other herbicides used in vietnam (1997). “different approaches have been used in estimating the exposure of vietnam veterans and these studies generally rely on selfreported exposures, records-based exposure estimates, or biomarkers of tcdd exposure. each of these approaches is limited in its ability to determine precisely the degree of individual exposure.” 105. sidath viranga panangala & douglas reid weimer, cong. research serv., 168 indiana health law review [vol. 17:153 the institutional rules associated with risk management proved to be limiting factors restricting change. the various actors self organized into their own silos with unique cultures, priorities, and resources creating barriers to changing the rules. focused on the military mission, the dod’s goal was on herbicide effectiveness at defoliation and crop destruction. courts struggled to adjudicate numerous lawsuits; the settlement did not reach all veterans exposed; congressional legislators balked at billion-dollar appropriations to the federal budget for claims. in 1991, twenty years after exposure, the agent orange act was enacted by congress to require the va to determine the association between the presenting disabilities and an herbicide agent.106 this legislation established for the first time the “presumption” of service connection with increased risk of diseases associated with herbicide exposure.107 as evidence of transformational policy change, the agent orange act also mandated the nas institute of medicine to undertake comprehensive biennial reviews of the evidence of health problems that may be linked to exposure to agent orange and other herbicides used during the vietnam war to determine whether there is a statistical association between the suspect diseases and herbicide exposure, taking into account the strength of the scientific evidence.108 as significant as the agent orange act legislation was hailed, however, va took until august 31, 2010, to promulgate its final regulation with publication in the federal register allowing presumption of exposure for veterans serving in vietnam between january 9, 1962, and may 7, 1975.109 in announcing the new rule for health care and disability compensation benefits some thirty-five years after the end of the conflict, the va secretary eric shinseki remarked, “it was the right decision, and the president and i are proud to finally provide this group of veterans the care and benefits they have long deserved.”110 twenty-eight thousand claims were decided by the va in the first six weeks of processing disability compensation applications based on the new regulation.111 rl34370, veterans affairs: health care and benefits for veterans exposed to agent orange 11 (2010). 106. agent orange act of 1991, 38 u.s.c. §1116 (2018). §1116(a)(3). herbicide agent was defined as “a chemical in an herbicide used in support of the united states and allied military operations in the republic of vietnam during the period beginning on january 9, 1962, and ending on may 7, 1975.” 107. panangala & weimer, supra note 105, at 3. 108. nat’l acad. sci. eng’r & med., supra note 28, at 2. 109. diseases associated with exposure to certain herbicide agents (hairy cell leukemia and other chronic b-cell leukemias, parkinson’s disease and ischemic heart disease), 75 fed. reg. 53,202 (aug. 31, 2010) (codified at 38 cfr 3.309). 110. press release, u.s. dep’t veterans aff., va publishes final regulation to aid veterans exposed to agent orange, (aug. 30, 2010), https://www.va.gov/opa/pressrel/pressrelease. cfm?id=1945 [https://perma.cc/5hub-9cza]. 111. press release, u.s. dep’t veterans aff, va processes first claims for new agent orange presumptives (dec. 17, 2010), https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2022 2020] exposure to complex environmental health challenges 169 ultimately, the executive branch through the va managed the risk and ensured scalability and reach by continuing to promulgate additional regulations for presumptive eligibility for disability compensation to include new conditions based on scientific evidence reported by nas.112 this coordination among congress in enacting the agent orange act, the nas in investigating the statistical association between science and illness, and the va in promulgating regulations led to the payment through august 2011 of over $2.2 billion in retroactive benefits to 89,000 veterans.113 this is evidence of a non-linear system in vital contact with multiple environments responding to chaos. the government and military’s risk management response to exposure of agent orange demonstrated a gross failure over decades for leadership protecting their individual missions to react in a coordinated, comprehensive, and timely manner. this comprehensive effort was long delayed. it took the energy of the advocacy movement and elected officials on behalf of victims to shake the equilibrium of an inert system to produce transformational management of the exposure of service members to agent orange. d. response to sodium dichromate exposure the united states shifted from primarily a full-time active command force during the vietnam war to a reserve component of a part-time active force. in 2010, 25 to 30 percent of the u.s central command forces were the reserve component.114 indeed, the national guard soldiers at qarmat ali water treatment plant were part-time, not full-time, soldiers who were deployed in an environment not to fight a war but to serve as the security force for kbr, a private contractor working on restoring the water treatment plant at basra, iraq.115 this all-volunteer military capability and increase in reserve forces contribute to the chaotic behavioral dynamics of the sodium dichromate matter. coincident to the decrease in full-time active command force has been an increase in the reliance of contractors for site security and logistical support, tasks the inspector general for iraq reconstruction admitted formerly were provided by active-duty forces.116 the ig concluded that “contracting in a hostile/combat [ https://perma.cc/wzd6-gjec]. 112. panangala & weimer, supra note 105, at 4. 113. press release, u.s. dep’t veterans aff. over $2.2 billion in retroactive agent orange benefits paid to 89,000 vietnam veterans and survivors for presumptive conditions (aug. 31, 2011), https://www.va.gov/opa/pressrel/docs/agentorangepresumptivesnr.doc [https://perma.cc/ t2fd-hzvu]. 114. u.s. dep’t def., quadrennial defense review 93 (2010). 115. inspector gen., u.s. dep’t of defense, exposure to sodium dichromate at qarmat ali iraq in 2003: part i evaluation of efforts to identify, contact, and provide access to care for personnel 2 (2010). 116. statement before the house subcomm. on nat’l sec. and foreign affairs, comm. on oversight and gov’t reform,111th cong. (june 29, 2010) (statement by stuart w. bowen, jr. 170 indiana health law review [vol. 17:153 environment is much more difficult and far more vulnerable” and there are “significant shortfalls in most aspects of contractor oversight.”117 although the dynamics surrounding the armed forces may be tightly monitored, the forces at work among the contractors’ activities are less certain. congressman earl blumenauer, advocating for declassification of the kbr contract on behalf of oregon national guardsmen exposed to sodium dichromate, said, “i remain concerned that kbr’s contract may be much more loosely drawn, removing incentives for the contractor to behave responsibly and exposing taxpayers to enormous liability and our troops to harm.”118 with thousands of sites within iraq, environmental risk assessments by the army pre-deployment to sites other than those on “major bed down locations” were considered impracticable.119 quoting a march 2009 letter from army secretary pete geren, u.s. senator evan bayh testified, “[o]rdinarily, the army would perform an environmental assessment of a site prior to deployment of service members or contractors to that site. in this case, however, the number of sites (approximately 4,000) over the geographic area of iraq potentially needing occupational health assessments in the immediate aftermath of hostilities, combined with the need to restore critical infrastructure as soon as possible, made this impracticable.”120 the dod inspector general concluded that “kbr did not fully comply with applicable occupational safety and health standards required by the contract, and tf rio failed to enforce contractor compliance.”121 an environmental risk assessment of the qarmat ali site prior to the service members’ arrival was neither performed by the army nor interpreted as required by kbr.122 linear communication of concerns raised and decisions by the contractors and the military operating within their own silos without feedback created a time delay in identifying and confirming exposure. on may 31, 2003, kbr representatives became aware of the use of sodium dichromate.123 on august 7, 2003, samples of air and soil/sediment from various areas were collected by kbr; duplicate samples were collected two days later.124 the august 7 & 9, inspector general, office of the special inspector general for iraq reconstruction). 117. id. 118. elana schor, military contractors were granted legal indemnity for hazardous substances, n.y. times (dec. 3, 2010), https://archive.nytimes.com/www.nytimes.com/gwire/ 2010/12/03/03greenwire-military-contractors-were-granted-legal-indemn-58060.html [https://perma.cc/2y3u-s4k6]. 119. letter from pate geren, sec’y of the army to evan bayh, senator, u.s. senate (march 2, 2009). 120. the exposure at qarmat ali: did the army fail to protect u.s. soldiers serving in iraq?: hearing before the s. democratic policy comm., 111th cong. (aug. 3, 2009) (statement of sen. evan bayh). 121. inspector gen., u.s. dep’t def., supra note 49, at 12. 122. see id. at 9, 33. 123. id. 124. id. at 41. 2020] exposure to complex environmental health challenges 171 2003, team rio qarmat ali site assessment trip memo and material safety data sheet documented the purpose of the trip to be “limited environmental assessment of soils potentially contaminated with sodium dichromate at the qarmat ali water treatment plant.” kbr personnel and kbr subcontractor personnel were advised that entry was restricted and until laboratory analyses were received.125 an environmental health and safety assessment was recommended to be completed to confirm “potential environmental health issues are identified and addressed.”126 also, minutes of a kbr staff meeting held august 8, 2003, included “serious health problem at water treatment plant with a chemical called sodium dichromate.127 almost 60% of people now exhibit the symptoms.” although these are ominous notes, the minutes characterized “[t]here is no reason for shutting down the water station.”128 as evidence of complex communication feedback loops, u.s. task force rio contracting officer officially was informed of the potential soil contamination on august 8, 2003,129 but it was not until almost five years later in june 2008 when the department of veterans affairs learned of the exposure.130 kbr required their subcontractor employees working in some areas to wear personal protective equipment (ppe) in august 2003;131 the wearing of ppe by all coalition personnel was not required until october 17, 2003. “on september 15, 2003, the combined forces land component command surgeon’s office notified [the u.s. army public health command provision] chppm of the potential exposure.”132 although the u.s. soldiers were exposed months earlier, access to the site was not restricted to them until september 19, 2003.133 dod readily admits the need to improve its occupational and environmental health surveillance activities including monitoring and documentation of 125. memorandum from johnny morney, john dipple & steve kegelman on kbr’s qarmat ali water treatment site assessment for the limited environmental assessment of soils potentially contaminated with sodium dichromate 4-5 (2003) (on file with author) [hereinafter qarmat ali water treatment site assessment memo]. the materials safety data sheet on sodium dichromate accompanying the memo outlined major health hazards for inhalation. 126. id. at 5. 127. team rio, minutes of meeting: meeting number mome03808 1 (2003) (on file with author). 128. id. minutes also indicated, “[s]odium dichromate could have been dumped on the ground for quite a long time. we do not know how deep it is but it looks like it is greater than 4 feet . . . . medical test every individual working in the area to assess level of exposure.” id. at 1-2. 129. inspector gen., u.s. dep’t def., supra note 49, at 12. 130. letter from eric k. shinseki, u.s. sec’y of veterans affairs, to john d. rockefeller, iv, u.s. senator from w. va. 1 (oct. 8, 2009). 131. qarmat ali water treatment site assessment memo, supra note 125, at 5. 132. inspector gen., u.s. dep’t of defense, supra note 115, at 3. 133. memorandum from the def. health bd. to ltg eric b. schoomaker, surgeon gen. of the army 7 (dec. 10, 2008) [hereinafter memorandum to schoomaker]. 172 indiana health law review [vol. 17:153 hazardous occupational and environmental incidents.134 “the services, including our commanders on the ground, have learned their lessons well pertaining to the need to fully characterize deployed environmental settings for possible exposures to hazardous materials and to ensure that the data is archived for future use.”135 after kbr health, safety, and environmental staff detected “elevated hexavalent chromium concentrations” at the qarmat ali plant, they “encapsulated various soil areas with a layer of liquid asphalt and loose gravel aggregate.”136 this action, unfortunately, eliminated medical impact pre-encapsulation which could have demonstrated more accurate results.137 indiana national guard and department of army civilians on site received serum and red blood cell testing for whole chromium, urine testing, pulmonary function testing, and chest x-rays within 30 days of last potential exposure and within 30 days of remediation of the site after the end of potential exposure.138 the u.s. center for health promotion and preventive medicine (chppm) incident response in october of 2003 initiated site sampling and medical testing for indiana army reserve national guard and department of army civilians.139 chppm reported that “nearly all test results were below the detection limit” concluding “there was not a significant inhalation exposure from chromium vi.”140 learning lessons from the experience of agent orange was mixed. on the one hand, the government having the smart-pm arrive soon after the notification of the incident shows a responsiveness to sodium dichromate exposure that was not evident with agent orange. on the other hand, even today, there is neither agreement as to the degree of exposure of the individual national guard members nor the effects of the toxicity of sodium dichromate to those 134. id. at 3. 135. statement before the house committee on government reform subcommittee for national security, emerging threats and international relations 6 (july 19, 2005) (statement of michael e. kilpatrick, deputy dir. of deployment health support directorate, dep’t of def). 136. memorandum to schoomaker, supra note 134, at 4. the defense health board stated, “[t]he decision by the usachppm assessment team not to provide medical exams to the entire available qarmat ali population in 2003 represents a lost opportunity for obtaining more complete knowledge of the possible medical impact of pre-encapsulation exposure.” inspector gen., u.s. dep’t of defense, supra note 49, at 22. 137. inspector gen., u.s. dep’t def., supra note 49, at 22. 138. see memorandum to schoomaker, supra note 134 at 3, 10. 139. see coleen baird weese, evaluation of exposure incident at the qarmat ali water treatment plant, army med. dep’t j. 10,10 (2009) https://ufdc.ufl.edu/aa00062689/00014 [https://perma.cc/jy2h-8444] (the special medical augmentation response team-preventive medicine (smart-pm) deployed “consisted of industrial hygienists, occupational medicine physicians, and environmental scientists” to do the testing). 140. u.s. army ctr for health promotion and preventive med., update on sodium dichromate exposure at qarmat ali water treatment plan in 2003 (for soldiers) 2 (2008), https://www.dpc.senate.gov/hearings/hearing49/september_2008_chppm_qarmatali_fact_ sheet.pdf [https://perma.cc/g5xz-ggs2]. 2020] exposure to complex environmental health challenges 173 exposed.141 this is remarkable as it demonstrates that the military has not learned from its experience with agent orange and especially its ongoing failure to recognize the importance of critical medical records. site location and exposure timelines are powerful drivers of access to both health care and epidemiology, and documenting that information is extraordinarily important. but with a rigid organization, inefficient processes, and significant time lapse, the medical records of the national guard were not accessible and “remained scattered throughout the medical records system;” paper medical records were sent from the unit to the mobilization site and returned to the unit following deployment.142 completeness of the medical records could not be assured with soldiers serving in multiple locations and redeployment with different units. absent accurate records to link service members’ symptoms to the chemical hazard, a special medical surveillance program was established for veterans with exam results tracked in the gulf war registry.143 “we have the names and contact information of all national guard members present at qarmat ali. we have also verified the numbers of these veterans who have received a gulf war registry (gwr) examination.”144 this learning from agent orange documents proximity to risk and health status. it is unfortunate that the dod and va have been challenged with incremental rather than transformational change to coordinate across missions and agencies to modernize their separate health records.145 the departments of dod and va fiercely have defended the privacy of their individual records preventing coordination across the mission and silos leading to sluggish incremental policy changes.146 “inevitability does not mean easy transition.”147 the u.s. house of representatives committee on veterans affairs in 2013 delivered a mandate to president obama, “[s]elect a system, pick a path and move forward. we can no longer waste the time or money that will result from endless bureaucratic 141. see inspector gen., u.s. dep’t def., supra note 49, at 16. 142. id. at 17, 22-33. 143. see paul ciminera, michael j. superior & tim bullman, findings from the department of veterans affairs qarmat ali medical surveillance program,181 military medicine 307, 310 (2016) (“the overall low participation rate in the va medical surveillance program of 15% severely compromises any generalization from this limited number of participants to the entire cohort of potential exposed veterans.”). 144. letter from eric k. shinseki, sec’y, dep’t of veterans affairs, to john d. rockefeller iv, senator, u.s. senate 1 (oct. 8, 2009). 145. see u.s. government accountability office, gao-11-265, electronic health records: dod and va should remove barriers and improve efforts to meet their common system needs (2011). 146. see id. 147. agency for healthcare research and quality, no. 14-0041-ef, a robust health data infrastructure 1 (2014) https://digital.ahrq.gov/sites/default/files/docs/ publication/a-robust-health-data-infrastructure.pdf [https://perma.cc/pn5y-6ub9]. 174 indiana health law review [vol. 17:153 inaction.”148 finally, the va is launching in spring 2020 the initial installation of the new electronic health record modernization (ehrm) program with interoperability with dod and community care providers to enable the sharing of patient information eliminating the manual transfer of records.149 the completion date, however, is 2028.150 the tolerance of risk of the kbr military contractors and the united states military differ based on their mission and relationship to the environment. the dod inspector general in 2011 concluded that the dod response to the contamination “lacked urgency and was incomplete. the delay may have occurred as a result of mission prioritization with the command.”151 the former u.s. army v corps commander explained, “[y]our focus changes completely, and you are either going to take your eye off the tactical fight in order to deal with the operational issues, or you are going to ignore the operational issues and stay involved in the tactical fight.”152 the kbr health, safety and environmental (hse) coordinator supporting rio noted soil and air samples “showed extremely high levels of hexavalent chromium in the soil” yet low levels of chromium in the air, explained with tests being conducted not “during one of the frequent dust storms in which all of the materials on the ground became airborne.”153 the coordinator believed “the plant was a highly dangerous and unsafe and contaminated facility;”154 he left his duties shortly thereafter. brown and root services was awarded the contract on march 8, 2003. on march 20, 2003, task order 3, “emergency response tasks for iraq oil reconstruction” was executed and was classified when published.155 the “administrative contracting officer had minimal, if any, opportunity to review the contract language once they deployed” and absent a classified computer system, discussions were precluded “between the administrative contracting 148. letter from members of the house veterans committee, to barack obama, president of the u.s. (may 22, 2013). 149. veterans ask, va answers: questions on electronic health record modernization, veterans affairs: vantage point (jan. 19, 2020), https://www.blogs.va.gov/vantage/70571/ ve t e ran s -ask-va-an sw ers -q u es t ion s -e lec t r o n ic-h ea lth -r ecord-m odern iza t ion / [https://perma.cc/hag5-wze4]. 150. id. 151. inspector gen., u.s. department of defense, supra note 49, at 16. 152. id.at 17. 153. the exposure at qarmat ali: contractor misconduct and the safety of u.s. troops in iraq: hearing before the s. democratic policy comm., supra note 58. 154. id. at 5. 155. to increase transparency and contractor accountability on indemnification agreements, the national defense authorization act of 2013, section 865, requires certain dod contract provisions to be reported to congress. wyden ndaa amendment to hold contractors accountable sent to the president, ron wyden senator for oregon (dec. 21, 2012). https://www.wyden. senate.gov/news/press-releases/wyden-ndaa-amendment-to-hold-contractors-accountable-sent-tothe-president [https://perma.cc/p7tv-2lm8]. 2020] exposure to complex environmental health challenges 175 officer and the contractor concerning contract language.”156 the dod ig concluded that the contract language was impractical.157 the language also was misinterpreted; “tf rio and kbr considered facilities to be ready for the contractor to begin work if they were free of military hazards” interpreting “benign” to mean “safe to operate from a security standpoint.”158 “this indicated all parties disregarded the “industrial” part of “environmental hazards” included in task order 3.”159 numerous legal challenges have been filed on behalf of service members seeking damages based on privately concealing risk and negligence among other allegations. these include: • forty-seven indiana national guardsmen filed a federal lawsuit alleging kbr, inc. privately concealed risk and “exposing them to a substantially heightened risk of cancer and other life-threatening illnesses.” although plaintiffs argued that they would return to “indiana, where they would subsequently experience health problems, such as cancer and kidney damage,” the court granted defendants’ motion to dismiss for lack of personal jurisdiction.160 • following a three-week u.s. district court trial, twelve oregon national guardsmen were awarded $85 million; each was to receive $850,000 in noneconomic damages and $6.25 million in punitive damages for “reckless and outrageous indifference.”161 the judge, however, “trimmed compensatory damages for each soldier to $500,000 because he determined oregon law required the reduction.”162 kbr was successful in its appeal of the jury verdict by the 9th u.s. circuit court of appeals arguing the trial court did not have personal jurisdiction; the case was referred back to oregon district court.163 • in turn, kbr filed suit against the united states in u.s. court of federal claims, alleging the indemnification clause in its contract was to protect kbr against “‘unusually hazardous’ risks” in iraq; therefore, the government 156. inspector gen., u.s. department of defense, supra note 49, at 9. 157. id. at 7. task order 3, paragraph 1.1.1 of the contract stated: “no earlier than the day after the ground forces secure an iraq oil infrastructure facility, contractor personnel shall be notified by aco that benign conditions exist.” 158. id at 8. 159. id. 160. mcmanaway v. kbr, inc., 695 f. supp. 2d 883, 887, 893, 896 (s.d. ind. 2010). 161. bixby v. kbr, inc., no. 3:09–cv–632–pk, 2013 wl 1789792, (d. or. apr. 26, 2013), aff'd, 2013 wl 12204397 (d. or. june 4, 2013), rev'd and remanded, 603 fed. app’x 605 (9th cir. 2015). 162. joany carlin, kbr verdict: judge affirms $81 million of damages awarded to 12 oregon soldiers for toxic exposure in iraq, oregonian (apr. 26, 2013), https://www.oregonlive.com/ health/2013/04/kbr_verdict_judge_affirms_most.html [perma]. 163. bixby v. kbr, inc., 603 fed. app’x 605, 606 (9th cir. 2015). 176 indiana health law review [vol. 17:153 should be liable for the judgment along with their attorney’s fees.164 congressional legislation was introduced, recognizing that future exposures are likely to occur, to advocate for medical evaluations of service members, to investigate the association between science and illness, and to increase accountability and transparency in defense contracts. in 2009, senator evan bayh introduced the health care for members of the armed forces exposed to chemical hazards act,165 and the health care for veterans exposed to chemical hazards act166 guided by government’s response to agent orange in vietnam to shift the evidentiary burden to receive medical care and to authorize a scientific review of the evidence linking all future exposures of “occupational and environmental health chemical hazards of particular concern” to adverse health effects.167 in addition, in 2012, senator ron wyden authored a provision adopted in the national defense authorization act to require the dod “to justify to congress the need for indemnification” clauses in dod contracts.168 the defense health board in its external review to address the potential sodium dichromate exposure said, “minimizing illness and injury from these sources or from the concomitant battle hazards requires not only the usual industrial hygiene approach, but also a judicious approach that balances the costs and benefits of incurring exposure at an industrial site and avoiding hazards of the battle environment.”169 v. shifting paradigm in spite of the sense of urgency to determine the association between potential exposure and disease incidence, change is inhibited by organizational policies, culture, political climate, and limited government resources, to say nothing of the scientific realities around the state of knowledge and technology.170 164. kellogg brown & root servs., inc. v. united states, 115 fed. cl. 46, 49 (2014). while the court of claims dismissed this lawsuit on grounds that it lacked jurisdiction over the claims presented, the armed services board of contract appeals subsequently held that kbr was entitled to indemnification. see kellogg brown & root services, inc., asbca nos. 59357, 59358 (aug. 13, 2015). 165. s. 642, 111th congress (2009) 166. s. 1779, 111th cong. (2009). 167. press release, evan bayh, senator for indiana, bayh: indiana soldiers exposed to toxic chemicals in iraq deserve expanded va care (august 3, 2009). 168. press release, ron wyden united states senator for oregon, the wyden-authored provision was included in the final house-senate conference agreement and passed by both houses (dec. 21, 2012), https://www.wyden.senate.gov/news/press-releases/wyden-ndaaamendment-to-hold-contractors-accountable-sent-to-the-president [https://perma.cc/jem7-uuk8]. 169. memorandum to schoomaker, supra note 134, at 8. 170. pamela a. mischen & stephen k. jackson, complexity theory and public administration: the role of organizations and organizational networks in policy implementation, paper presented at the conference of the public administration theory in harrisburg, pa (may 26, 2007) at 14. 2020] exposure to complex environmental health challenges 177 new approaches to risk management by the executive branch should be developed for transformational change. authorizing a scientific review of the evidence linking exposure to chemicals of particular concern to adverse health effects, establishing a registry of service members potentially harmed, shifting the burden of evidence from the injured to the government, and requiring front line commanders to report hazardous material exposure to their non-deployed headquarters should be considered. the legislative branch could impact risk management as well. rather than continue to legislate relief from harm by name of the war, geographic location of incident, calendar years, or health consequence/disease that excludes service members from eligibility to benefits, new legislative language should recognize that risk is inherent with military service. legislation should provide the flexibility federal administrators require to act swiftly in coordination with stakeholders in times of national emergency without compromising processes for human safety, environmental threats, public health, fiscal responsibility, enforcement, and national security. federal courts have a role to play in risk management. the judicial branch must assess congressional legislative intent, the executive branch’s management of risk, and the scientific evidence from experts. courts play an important role in determining reasonableness. courts wrestle with determining compensation for health and environmental harms, deciding causation, and evaluating scientific evidence competently.171 science must be translated within the confines of statutory authority and administrative regulation leaving some stakeholders dissatisfied with the result.172 all of this requires the judiciary to keep up to date with scientific knowledge in order to conclude which scientific evidence is valid and to balance risks with benefits. reforms in the executive and judicial branches are needed. only the congress, however, can clarify these questions from the public health perspective through enacting or amending legislation to articulate the role of the government, manufacturers, administrators, contractors, and the taxpayers to ensure risk is fairly shared in the united states. environmental challenges should be explored openly rather than trying to assign blame and sanction, and strategies for intervention could be distributed over the system. a veteran’s own report of exposure and inclusion on a registry, for example, should be sufficient proof to receive medical evaluations unless there is evidence to the contrary. moving away from a performance management approach of blame and sanction removes risk management out of the adversarial and costly judicial environment. considering the challenges experienced with the exposure to agent orange and sodium dichromate, policy recommendations are identified. implementation 171. peter s. menell, the limitations of legal institutions for addressing environmental risks, 5 j. econ. persp. 93, 99-100 (1991). 172. see milton russell & michael gruber, risk assessment in environmental policy-making, 236 science 286, 286 (1987). 178 indiana health law review [vol. 17:153 of these recommendations listed from greatest impact could shift the paradigm from managerial control to monitoring information; from rigid and localized control to control distributed over the system; and from blame and sanction to problems explored openly: • establish a single uniform contracting process for use during contingency operations173 with a new integrated office and a working group from relevant federal agencies for planning and execution.174 • develop and require joint planning in operational settings among the armed forces, contractors, and army corps of engineers to ensure prompt identification and comprehensive mitigation of environmental risks.175 • ensure the classification of documents balances the need for security with timely dissemination to meet the health care needs of service members and other stakeholders, to facilitate communication, and to reduce distrust.176 • condense the implementation schedule from 2028 to 2025 for the electronic health record modernization (ehrm) program’s replacement of the current veterans health information systems and technology architecture (vista) system. • enact legislation that provides a veteran’s inclusion on a registry to be “recognized as sufficient proof to receive medical care barring evidence to the contrary shifting the evidentiary burden to the federal government.”177 • require the inclusion in ehrm all deployment date(s), location, and job assigned during deployment; potential exposures to chemicals of concern; and status of health information generated as a result of exposure.178 • require dod to create, keep current, and permanently maintain registries of all service members who are deployed. the registries should include date(s), location, and job assigned during deployment; potential exposures to chemicals of concern; and status of health information generated as a result of exposure.179 • re-examine and revise megs to reflect multiple deployments and to recognize the variability of the general population who serve in the armed forces.180 173. “the contingency support plan for repair and continuity of operations of the iraqi energy infrastructure, dated january 31, 2003, stated the mission was to ‘support the commander, u.s. central command in the assessment of damage, repair, maintenance, resumption and/or continuity of the operations of the oil infrastructure of iraq.’” inspector gen., u.s. department of defense., supra note 49, at 7. 174. statement before the house subcomm. on nat’l sec. and foreign affairs, comm. on oversight and gov’t reform, supra note 116. 175. memorandum to schoomaker, supra note 134, at 3. 176. id. at 3, 9. 177. the exposure at qarmat ali: did the army fail to protect u.s. soldiers serving in iraq?, supra note 120, at 3. 178. see memorandum to schoomaker, supra note 134, at 11. 179. see id. at 12. 180. u.s. army pub. health command, supra note 67, at 6, 21. 2020] exposure to complex environmental health challenges 179 • require the secretary of dod to enter into agreements with the nas for each incident of exposure that the secretary of dod determines is of particular concern to assess the strength concerning the association between the exposure to such hazard and acute and long-term health consequences of such exposure. • require the u.s. army public health command (provision) to assess and confirm that individuals with a potential exposure have access to one primary contact to receive information on the nature of the exposure, to participate in appropriate medical surveillance programs, and to be referred to the proper specialty service.181 • enact legislation at the state level to require all hospitals to ask the question, “have you ever served in the military?” to ensure service members receive timely diagnoses and appropriate health care.182 • review and revise competencies for hazard recognition training, comprehensive investigations, and risk communications for commanders.183 • conduct an assessment to assure expertise exists in epidemiology and industrial toxicology among dod and va professionals, and identify individuals with a specific and broad spectrum of expertise to facilitate access to a consultation on risk assessment and risk management to relevant federal agencies.184 • re-examine the military claims act185 and the federal tort claims act186 to consider contractor participation in military deployments.187 vi. conclusions “it is inevitable that military units will encounter potentially hazardous industrial sites during combat operations. the hazards encountered may pose risks of infectious disease, poisonings from industrial toxins, or injuries.”188 environmental challenges that the military as a complex organization must confront and resolve cannot be broken down into discreet compartments to be addressed by individual disciplines. given the timing of the mission, environmental risk assessments in a war zone may not be conducted, access to important and critical data may be hindered because of the prolific use of private 181. see memorandum to schoomaker, supra note 134 at, at 11. 182. see am. acad. of nursing, have you ever served in the military: a service for america’s veterans by the american academy of nursing, haveyoueverserved.com, http://www.haveyoueverserved.com/about.html [https://perma.cc/778c-sm24]. 183. memorandum to schoomaker, supra note 134, at 12. 184. id. at 3. 185. 10 u.s.c. §2733 (2018). 186. 28 u.s.c. §§1346, 2680 (2018). 187. see william spyro speros, friend-of-a-friendly fire: a future tort issue of contractors on the battlefield, 35 pub. cont. law j., 297 (2006). 188. memorandum to schoomaker, supra note 134, at 8. 180 indiana health law review [vol. 17:153 contractors, and the evaluation for both health and mission risks limit risk management options. in an environment in which our national security may depend on timely and accurate decisions, relationships among agents, and positive feedback in interactions are essential. determining the strategy for risk communication to inform the public about a potential risk while tolerating their fear is a challenge for public officials.189 for the public to accept risk, public officials have an enormous task to ensure that their policies can be characterized as credible and fair. the perception of risk depends on trust that the information provided is evidence based, accurate, thorough, and honest. the perception of risk is dependent on whether it is considered voluntary or involuntary.190 public officials have a particular challenge of communicating risk associated with policy options during emergencies and when balancing options that are neither strictly beneficial nor strictly harmful. the “goal is not to change people’s opinions about controversial environmental issues. the goal is to change the way we discuss these issues, make the discussions accurately reflect the risks we face and the available options, and enable us to make effective decisions,”191 for the public, however, to determine their own tolerance of risk, they must have uncertainties acknowledged.192 “scientists must be willing to take a larger role in explaining the risks to the public, including the uncertainties inherent in any risk assessment.”193 congressional legislation, federal statutes, and executive courage may not yet be calibrated appropriately to provide the flexibility federal administrators require when acting swiftly in times of national emergency without compromising processes for human safety, fiscal responsibility, and national security. a new model for risk management for service members who have been exposed to complex occupational and environmental chemicals applying complexity theory may be required. advancing beyond a “multiple-single uncertainty factor system” that assumes “estimates of health protection benefit can be juxtaposed with the costs of health protection measures,” is necessary.194 the complexity of knowledge begs for non-linear understanding. complexity theory can help us understand how organizations function and 189. peter m. sandman, crisis communication best practices: some quibbles and additions. 34 j. applied comm. res. 257, 258 (2006). 190. christopher j. daggett, the role of risk communication in environmental gridlock, in effective risk communication: the role and responsibility of government and nongovernment organizations 31, 32 (vincent t. covello, peter m. sandman, and paul slovic eds, 1989). 191. id. at 35. 192. vincent t. covello, peter m. sandman, & paul slovic, risk communication, risk statistics, and risk comparisons: a manual for plant managers, in effective risk communication: the role and responsibility of government and nongovernment organizations 297, 329 (vincent t. covello, peter m. sandman, & paul slovic eds, 1989). 193. william ruckelshaus, science, risk and public policy, 221 sci. 1026, 1028 (1983). 194. inst. of med., environmental health sciences decision making: risk management, evidence, and ethics: workshop summary 4 (2009). 2020] exposure to complex environmental health challenges 181 encourage new perspectives working in both non-linear and non-vertical processes across agencies to create new relationships for transformational change. agents’ behavioral responses are dependent on past experience. however, adaptation and evolution, indeed, are possible as greater receptivity to smaller procedural changes could result in larger impacts. recognizing that stakeholders in the public policy process approach risk management differently, the infrastructure that enables the executive judicial and legislative branches and their agents to respond appropriately to chemical exposure demands reform. creating an environment that promotes innovation and rapid problem solving is essential. “as energy flows between agents, conditions change, and create a state of nonequilibrium. this dissipative transfer of energy allows for movement, interaction and reaction to the environment.”195 joint risk management planning efforts must be refined anticipating the next emergency when neither medical expertise nor chemical mixture experience is available to assess risk, recordkeeping is lacking, proof of exposure is questionable, and the relationship of the chemical hazard and the health effect is not certain. such a new model would establish a registry of those potentially harmed, an independent entity that could conduct a scientific review of the evidence linking certain medical conditions to exposure and a shift of the burden of evidence from the injured to the government. the development of uniform standards for the electronic exchange of health information among the u.s. departments of defense, veterans affairs, and health and human services and community health care providers would facilitate not only the provision of health care but enhance the identification of emerging diseases and health threats.196 the military is influenced by its hierarchy of agents or actors whose behavior and interactions act as the catalyst for the organization to self-organize. however, agents may be restricted by limiting mechanisms that diminish possibilities for change within or external to its networks.197 “each population has its own history, culture, and socioeconomic structures.”198 the military as an institution is unique in that all decisions of the armed forces are dependent on its specific mission. as 195. pamela a. mischen & stephen k. jackson, complexity theory and public administration: the role of organizations and organizational networks in policy implementation. paper presented at the conference of the public administration theory in harrisburg, pa (may 26, 2007) at 18. 196. see statement before the house comm. on gov’t reform, subcomm. for nat’l sec., emerging threats and int’l relations, 109th cong. 6, 13, 17 (2005) (statement of michael e. kilpatrick, deputy director, deployment health support directorate department of defense). 197. pamela a. mischen. complexity theory and public administration: the role of organizations and organizational networks in policy implementation. paper presented at the conference of the public administration theory network in harrisburg, pa (may 26, 2007), at 14. 198. neil pearce & franco merletti, supra note 2. 182 indiana health law review [vol. 17:153 such, the risk management processes are an integral component of this unique complex adaptive system. “risk management is not an add-on feature to the decision-making process but rather a fully integrated element of planning and executing operations. . . . risk management helps us preserve combat power and retain the flexibility for bold decisive action. proper risk management is a combat multiplier that we can ill afford to squander.” general d.j. reimer, chief of staff army, 1995 (da 1998)199 199. u.s. army ctr for health promotion and preventive med., usachppm technical guide 230: chemical exposure guidelines for deployed military personnel 3 (2003). medicaid: a safety net for the “wealthy” robert east* i. introduction at a time when the cost of long-term nursing home care is exceptionally high, most older middle-class americans are struggling to foot the bill for the care they require. for wealthy americans, on the other hand, this is a time of opportunity. medicaid is a public assistance program initially intended to be a safety net for the truly needy, i.e., the individuals with low income and the medically needy.1 however, medicaid has become the primary payer for long-term care in the united states despite its intended role as a “safety net.”2 due to medical technology advancements and increases in life expectancy, long-term care has become so expensive that only a few can afford it.3 those facing a lengthy nursing home stay have two choices: deplete their lifetime savings until they are poor enough to qualify for medicaid or engage in medicaid planning to protect their assets. wealthy couples quite easily can, and do, choose the latter. as with everything in life, those with greater means have greater options. so, while the government takes measures to restrict medicaid for the needy, members of the upper class have uncovered a slew of alternative legal strategies to qualify them for medicaid benefits, nonetheless. during her 2011 congressional testimony, one 36-year career medicaid eligibility supervisor provided a witness account of wealthy individuals repositioning significant resources to qualify for medicaid: it is not at all unusual to encounter individuals and couples with resources exceeding a half million dollars, some with over one million. there is no attempt to hide that this money exists; there is no need. there are various legal means to prevent those funds from being used to pay for the applicant’s nursing home care. wealthy applicants for medicaid’s nursing home coverage consider that benefit to be their right, regardless of their ability to pay themselves.4 moreover, research published in the american economic review discovered that * j.d. candidate, 2022, indiana university robert h. mckinney school of law, indianapolis, indiana; b.s., 2013, university of evansville, evansville, indiana. 1. christopher j. truffer et al., 2016 actuarial report on the financial outlook for medicaid, ctr. medicare & medicaid servs. 1, 2 (2016), https://www.cms.gov/researchstatistics-data-and-systems/research/actuarialstudies/downloads/medicaidreport2016.pdf [https://perma.cc/rvh8-z2le]. 2. id. 3. see generally chris pope, taking the strain off medicaid’s long-term care program, manhattan inst. 1 (2020), https://media4.manhattan-institute.org/sites/default/files/taking-strainoff-medicaids-long-term-care-program-cp.pdf [https://perma.cc/c3r8-eh6e]. 4. stephen a. moses, how to fix long-term care financing, found. gov. accountability 1, 10 (2017), https://thefga.org/wp-content/uploads/2017/07/how-to-fix-longterm-care-financing.pdf [https://perma.cc/ws8q-3fze] (emphasis added). 456 indiana health law review [vol. 19:455 not only can the wealthy enroll in medicaid, but when they do, their long-term care costs taxpayers more than long-term care for low-income individuals.5 this note primarily applies where one spouse is seeking medicaid benefits for nursing facility care and the other spouse remains at home. the nursing home applicant is the “institutionalized spouse,” while the spouse not seeking medicaid benefits is the “community spouse.”6 part ii of this note briefly explains the medicaid program and its history. part iii provides insight into the costs and budgetary impact of financing long-term care in america. part iv discusses medicaid’s eligibility requirements and penalties. part v illustrates commonly used medicaid planning techniques to preserve assets and gain medicaid eligibility. part vi explores a handful of proposals for reforming the medicaid program. part vii looks at an innovative partnership program offered by many states to encourage americans to purchase private long-term care insurance. finally, part viii provides a brief perspective and suggests the medicaid program embrace rather than discourage the wealthy elderly from using medicaid. ii. an overview of the medicaid program medicaid was first established by congress in 1965 as part of the social security act in response to the widespread perception that welfare medical care provided under public assistance was inadequate.7 the federal government primarily funds medicaid; however, medicaid is administered exclusively by the states.8 while state participation in the medicaid program is technically voluntary, all 50 states have participated since 1982.9 “[i]n exchange for federal funding, participating states must comply with the requirements imposed by the [medicaid] act and with regulations promulgated by the secretary of health and human services” (“hhs”).10 the centers for medicare and medicaid services (“cms”), a division of hhs, maintains oversight of state-administered medicaid programs.11 as long as the minimum requirements promulgated by hhs are met, states have relatively broad discretion in deciding whom to cover, what eligibility 5. pope, supra note 3, at 9. 6. andrew d. wone, don’t want to pay for your institutionalized spouse? the role of spousal refusal and medicaid in funding long-term care, 14 elder l.j. 485, 493 (2006). 7. barbara s. klees et al., brief summaries of medicare & medicaid: title xviii and title xix of the social security act, ctrs. medicaid & medicare servs. 1, 3 (2009), https://www.cms. gov/research -s t a t is t ic s-data-and-systems/stat ist ics-trends-and-reports/medicare programratesstats/downloads/medicaremedicaidsummaries2009.pdf [https://perma.cc/9jhuqh8u]. 8. jeffrey r. grimyser, missing the forest for the trees: why supplemental needs trusts should be exempt from medicaid determinations, 89 chi.-kent l. rev. 439, 441-42 (2014). 9. id. 10. missouri dep’t of soc. servs., div. of med. servs. v. great plains hosp., inc., 930 s.w.2d 429, 431 (mo. ct. app. 1996). 11. john a. miller, voluntary impoverishment to obtain government benefits, 13 cornell j.l. & pub. pol’y 81, 85 (2003). 2022] medicaid: a safety net for the “wealthy” 457 limits to set, and what medical services to cover.12 while it sounds relatively straightforward on paper, interrupting the complex medicaid act is no easy feat for anyone, including the states and cms themselves. one u.s. district court summarized this complexity the best: the medicaid act is actually a morass of interconnecting legislation. it contains provisions which are circuitous and, at best, difficult to harmonize. the act has been called ‘an aggravated assault on the english language, resistant to attempts to understand it.’ the medicaid act has been characterized as one of the ‘most completely impenetrable texts within human experience’ and ‘dense reading of the most tortuous kind.’ the court has nothing but sympathy for officials who must interpret or administer the act.13 because of the complexity of the medicaid act and the broad discretion afforded to states, there is considerable variation in medicaid programs across the county. for simplicity’s sake, this note will reference a combination of indiana and federal medicaid requirements where applicable. it is essential to note the distinction between medicare and medicaid. generally, medicare is the primary source of healthcare for people age 65 and older.14 medicare covers medically necessary services such as prescription drugs, lab tests, hospice care, and surgery.15 medicare does not provide long-term care benefits, most often associated with custodial care in a nursing home.16 under limited circumstances, medicare may provide limited coverage for custodial care in a nursing home if a doctor orders the care as a follow-up to a qualifying inpatient hospital stay and if the care is related to the delivery of specialized medical services or rehabilitation.17 even then, medicare only covers the total cost of custodial care in a nursing home for 20 days.18 for days 20 through 100, medicare’s coverage of custodial care in a nursing home is limited, and a daily coinsurance applies – $185.50 per day in 2021.19 after 100 days, medicare 12. crystal francis et al., medicaid for the elderly and disabled in indiana, ind. continuing legal educ. f. 1, 3 (2018). 13. mertz ex rel. v. houstoun, 155 f. supp. 2d 415, 420 (e.d. pa. 2001) (internal citations omitted). 14. lita epstein, medicaid and nursing homes: a quick guide to the rules, investopedia, https://www.investopedia.com/articles/personal-finance/072215/quick-guide-medicaid-and-nursinghome-rules.asp [https://perma.cc/3akp-6xvj] (last updated aug. 19, 2020). 15. jill seladi-schulman, medicare coverage for long-term care: what you need to know, healthline (may 5, 2020), https://www.healthline.com/health/medicare/does-medicare-coverlong-term-care#types-of-long-term-care [https://perma.cc/w5sp-eat3]. 16. epstein, supra note 14. 17. id. 18. skilled nursing facility (snf) care, medicare.gov, https://www.medicare.gov/ coverage/skilled-nursing-facility-snf-care [https://perma.cc/5x4d-6cmn] (last visited mar. 11, 2021). 19. id. 458 indiana health law review [vol. 19:455 coverage ends, leaving the patient responsible for the entire cost of custodial care from that point on.20 on the other hand, medicaid includes coverage for most long-term care services and does not impose a durational limit on coverage.21 medicaid provides coverage for preventative, acute, and long-term care medical services for low-income individuals and individuals with disabilities.22 in addition to income, medicaid eligibility is based on additional factors, such as age, disability, other government assistance, other medical conditions, and financial resources (or assets).23 iii. financing long-term care in america healthcare in america is expensive. however, long-term care in america is unconscionably expensive. fidelity investments estimates that the average 65year old couple with medicare insurance will need approximately $295,000 to cover medical expenses during retirement, not including long-term care expenses such as nursing home care.24 when factoring in long-term care expenses from age 65 to death, the same couple would need an additional $276,000 to $500,000.25 this is especially alarming, considering the median retirement savings among baby boomers is only $288,000 per couple26 – well short of the $571,000 to $795,000 that may be needed for medical and long-term care.27 unfortunately, it is not a question of if those age 65 and older will need longterm care; it is a question of when they will need it. of individuals reaching age 65, an estimated 70% will develop significant long-term care needs.28 the number of americans requiring long-term care is expected to more than double from 12 million in 2010 to a staggering 27 million by 2050.29 while this increase may be attributed to the baby boomers, it can also be attributed to the rising life 20. id. 21. medicaid coverage of nursing home care: when, where and how much they pay, am. council on aging, https://www.medicaidplanningassistance.org/medicaid-and-nursing-homes/ [https://perma.cc/m2ak-z2sj] (last updated jan. 11, 2021). 22. see alison mitchell et al., medicare: an overview, cong. rsch. serv. 1, 8 (2021), https://fas.org/sgp/crs/misc/r43357.pdf [https://perma.cc/j8gh-9wnx]. 23. truffer et al., supra note 1, at 2. 24. how to plan for rising health care costs, fidelity (aug. 31, 2021) www.fidelity.com/ viewpoints/retirement/retiree-health-costs-rise [https://perma.cc/29xy-5rve]. 25. pope, supra note 3, at 6 (providing average individual long-term care expenses). 26. see maurie backman, the median retirement savings balance among baby boomers is shockingly low, motley fool (june 15, 2020, 7:18 am), https://www.fool.com/retirement/ 2020/06/15/the-median-retirement-savings-balance-among-baby-b.aspx [https://perma.cc/dl8g45at]. 27. see how to plan for rising health care costs, supra note 24; see also pope, supra note 3, at 6. 28. pope, supra note 3, at 6. 29. id. at 5. 2022] medicaid: a safety net for the “wealthy” 459 expectancy and significant advances in healthcare delivery.30 the increase in the amount of elderly needing long-term care is sure to place a heavy burden on medicaid and, ultimately, the working-age taxpayer (defined as persons aged 18 to 64).31 in 2000 the ratio of working-age persons for every person age 65 and older was 5, but by 2030, the ratio will have dropped to only 2.9 working-age persons for every person age 65 and older – a whopping 44% decrease.32 as this ratio drops, working-age taxpayers are likely to see a more significant portion of their earnings taxed to support the growing medicaid program. medicaid spending represents a significant portion of state and federal budgets.33 in 2015, federal and state spending on medicaid totaled $554 billion.34 moreover, medicaid represents an estimated 28% of all state government spending.35 interestingly, medicaid, not medicare or private insurance, is the largest funding source for long-term care in the united states.36 of the $379 billion spent on long-term care in 2018, medicaid accounted for a whopping 52%, whereas private insurance, out-of-pocket spending, and other payers only accounted for 16%, 11%, and 20%, respectively.37 the intensity of care required drives much of the expense associated with an individual’s long-term care.38 in 2019, annual costs averaged $22,100 for adult daycare, $49,200 for an assisted-living facility, $52,624 for a home health aid, $84,253 for a semi-private nursing home room, and $102,200 for a private nursing home room.39 the median wealth of the elderly admitted to nursing homes averages $108,000 at the time of admission but quickly declines to about $5,000 after only six months of long-term care-related expenses.40 of those admitted to nursing homes, only an estimated 14% had long-term care insurance.41 iv. eligibility for medicaid long-term care benefits to qualify for medicaid benefits, the applicant must first satisfy income and 30. id. 31. old-age support ratio, population reference bureau, https://www.prb.org/ usdata/indicator/elderly-support-ratio/snapshot/ [https://perma.cc/zgf4-gl8e] (last visited feb. 12, 2021). 32. id. 33. truffer et al., supra note 1, at 34. 34. id. at 5. 35. id. at 34. 36. id. at 33. 37. pope, supra note 3, at 6. 38. id. 39. cost of care survey, genworth, https://www.genworth.com/aging-and-you/finances/ cost-of-care.html [https://perma.cc/j822-2bep] (last visited nov. 8, 2020). 40. pope, supra note 3, at 7. 41. id. 460 indiana health law review [vol. 19:455 resource requirements set by the state and federal medicaid laws.42 before 1988, medicaid subjected married couples to the same asset limitations as individuals, even if only one spouse sought benefits.43 if the married couple had assets above the maximum allowance, they had to “spend down” all of their collective assets until the assets were within the permissible limit.44 however, the asset spenddown usually left the community spouse impoverished, leaving many elderly couples to divorce as a strategy for avoiding poverty.45 congress recognized that problem and subsequently passed the “spousal impoverishment provisions” of the medicare catastrophic coverage act of 1988.46 [the spousal impoverishment provisions] were designed to ensure that the community spouse had a necessary, but not excessive, amount of assets protected from inclusion in the institutionalized spouse’s eligibility for medicaid, and as such, these exempt assets did not need to be ‘spent down’ for the institutionalized spouse’s care.47 this note will highlight that the legislature may have provided married couples with too much leniency. to be clear, the spousal impoverishment provisions apply when a married individual is seeking medicaid long-term care benefits; they do not apply when an individual is seeking benefits under the traditional state medicaid program (i.e., no long-term care benefits).48 a. income eligibility for eligibility purposes, “income” means the applicant’s gross income minus medicaid-permitted deductions, such as health insurance premiums, taxes, courtordered payments,49 and medical expenses not covered by medicaid.50 typical income sources for elderly nursing home applicants include social security benefits, pensions, and interest from investments.51 for an individual to be eligible for traditional medicaid benefits, the income limit usually is 100% of the 42. see generally 42 u.s.c. § 1396 et seq.; see also ind. code § 12-15 et seq. (2021). 43. elizabeth d. lauzon, annotation, application of “spousal impoverishment provisions” of medicare catastrophic coverage act (42 u.s.c.a. § 1396r-5), 186 a.l.r. fed. 437 § 2[a] (2003). 44. id. 45. id. 46. id.; see 42 u.s.c. § 1396r-5. 47. lauzon, supra note 43. 48. how medicaid’s minimum monthly maintenance needs allowance works & 2021 limits, am. council on aging, https://www.medicaidplanningassistance.org/ mmmna-definition/ [https:// perma.cc/4m4s-exw4] (last updated jan. 4, 2021). 49. see, e.g., mulder v. s.d. dep’t of soc. servs., 675 n.w.2d 212 (s.d. 2004). 50. see generally ind. fam. & soc. servs. admin., ind. health coverage program policy manual § 3455.15.10 (2016), https://www.in.gov/fssa/ompp/files/ medicaid_pm_ 3400.pdf [https://perma.cc/3bll-zbw5]. 51. lauzon, supra note 43. 2022] medicaid: a safety net for the “wealthy” 461 federal poverty level.52 while this income cap works for the traditional medicaid program, it does not work for determining eligibility for nursing home care;53 nursing home care averages $84,253 for a semi-private nursing home room and $102,200 for a private nursing home room.54 because the traditional income cap would leave too many elderly unable to pay for long-term care but too “rich” to qualify for medicaid, the legislature established a higher income cap for determining medicaid eligibility for nursing home residents.55 under the increased income cap, the applicant’s income may not exceed 300% of the supplemental security income level – currently $2,382 per month (or $28,584 per year) for 2021.56 the preceding income rules apply to every medicaid applicant, but due to the spousal impoverishment provisions, some special rules apply when determining a married applicant’s income. first, all income received solely by the institutionalized spouse is attributed to the institutionalized spouse for the eligibility assessment.57 second, income received solely by the community spouse is neither factored into the income eligibility assessment nor considered available to the institutionalized spouse after eligibility is established and institutionalization has occurred.58 third, concerning the income received by the couple jointly, half is considered income of the community spouse (thus, excluded from the eligibility assessment), and the other half is considered income of the institutionalized spouse (thus, factored into the eligibility assessment).59 once the institutionalized spouse’s income is determined, it must not exceed the 300% social security income level threshold described above.60 however, if an applicant’s income exceeds the eligibility income cap, he may still qualify for medicaid benefits if he allocates the income over the cap into a supplemental needs trust, more famously known as a “miller trust.”61 because miller trusts 52. see 42 u.s.c. § 1382(a)(2). under the regular medicaid income eligibility rules for 2021, an individual applicant must not have income exceeding $1,752 per month, or $21,024 per year. a married applicant and his spouse must not have a combined income exceeding $2,628 per month, or $31,536 per year, regardless of if the spouse is not seeking benefits. 53. francis et al., supra note 12, at 96. 54. cost of care survey, supra note 39. 55. francis et al., supra note 12, at 96-97 (the higher income cap for nursing home residents may also be referred to as the “special income level”). 56. ind. fam. & soc. servs admin., ind. health coverage program policy manual § 3010.20.15 (2016), https://www.in.gov/fssa/ompp/files/medicaid_pm_3000.pdf [https://perma. cc/jh2l-t2dq] [hereinafter ind. health coverage program policy manual]; francis et al., supra note 12, at 96-97. 57. francis et al., supra note 12, at 96-97; see ind. code § 12-15-3-1.5 (2021). 58. 42 u.s.c. § 1396r-5(b)(1); ind. code § 12-15-3-1.5. 59. spousal impoverishment protection law, ind. long term care ins. program, https://www.in.gov/iltcp/2340.htm [https://perma.cc/y738-qbve] (last visited mar. 29, 2021). 60. wone, supra note 6. 61. grimyser, supra note 8, at 447-48; see generally 42 u.s.c. § 1396p. the miller trust gets its name from miller v. ibarra, 746 f. supp. 19 (d. colo. 1990), which held that trusts 462 indiana health law review [vol. 19:455 are frequently misunderstood and misrepresented, the following paragraph will deviate briefly to provide a clarifying overview of miller trusts. “a trust is a fiduciary relationship in which a trustor gives another party, known as the trustee, the right to hold title to property or assets for the benefit of a third party.”62 because the beneficiary, or medicaid applicant, does not technically own the assets held in the trust, he can utilize the trust to avoid specific legal requirements.63 concerning medicaid eligibility, an applicant with income exceeding the income cap cannot qualify for medicaid benefits unless he puts his excess income in a miller trust.64 the now-medicaid-eligible individual may then use the assets held in the miller trust to pay for services and items not covered by medicaid – such as specialized therapy, clothing, toiletries, television, and books.65 interestingly, the common misconception between laypersons and some professionals alike is that a miller trust is some creative tool utilized by the wealthy to shelter assets. however, this is not the case because the medicaid statute limits the potential for abuse by imposing two critical conditions.66 first, medicaid requires the use of the assets held by the trust only for the beneficiary of the trust, i.e., the individual receiving medicaid benefits.67 second, medicaid must be the sole beneficiary of the trust upon the individual’s death so that any remaining assets reimburse the state for its expenses.68 in reality, the miller trust represents a “bargain” between the trust beneficiary and the state: “[t]he beneficiary remains eligible for medicaid while using the [trust]…, but the state will be paid back before the beneficiary may give any remaining assets to his or her heirs.”69 once the institutionalized spouse satisfies the income eligibility assessment, (which is easy to do thanks to the miller trust, as discussed in the deviating paragraph above), the next step is to determine how much of his income he must contribute toward his respective nursing home expenses (referred to as monthly “liability”).70 medicaid provides a limited amount of deductions when computing monthly liability.71 common deductions from the institutionalized spouse’s monthly liability include consisting of the income of nursing home residents were not countable income for medicaid eligibility. 62. julia kagan, trust, investopedia, https://www.investopedia.com/terms/t/trust.asp [https://perma.cc/d6xs-qkbu] (last updated oct. 19, 2020). 63. grimyser, supra note 8, at 443. 64. what are the uses for a miller trust?, hg.org, https://www.hg.org/legal-articles/whatare-the-uses-for-a-miller-trust-45532 [https://perma.cc/hs9w-49zv] (last visited feb. 12, 2021). 65. grimyser, supra note 8, at 443. 66. 42 u.s.c. § 1396p. 67. grimyser, supra note 8, at 468. 68. id. at 448. 69. id. 70. wone, supra note 6; see ind. health coverage program policy manual, supra note 56, § 3455.15.00. 71. see ind. health coverage program policy manual, supra note 56, § 3455.15.00. 2022] medicaid: a safety net for the “wealthy” 463 (1) a personal needs allowance of $52 per month (which may be used to purchase items and services not covered by medicaid); (2) health insurance premiums; (3) medical expenses not covered by medicaid or a third party; (4) federal, state, and local income tax; and (5) a minimum monthly maintenance needs allowance (“mmmna”) for the community spouse.72 the last deduction mentioned, the mmmna, represents an enormous opportunity to protect a couple’s assets and reduce the institutionalized spouse’s monthly liability. under the spousal impoverishment provisions, the states must set a minimum monthly income allowance for the community spouse.73 the allowance is deducted from income, and thus, it may not be allocated to monthly liability.74 the mmmna is established by assessing the community spouse’s monthly income and her respective ability to pay monthly expenses such as mortgage or rent, utilities, taxes, and other related household expenses.75 mmmna is only applicable if the community spouse’s income is under a particular limit – specifically, if her income is less than the mmmna or her income is insufficient to pay her monthly expenses.76 the mmmna must be at least $2,155 per month, regardless of the community spouse’s actual monthly expenses are less than that amount.77 if the community spouse’s income is less than the prescribed mmmna or her income is insufficient to cover her monthly expenses, a portion of the institutionalized spouse’s income will be allocated to her instead of his monthly liability.78 however, if the institutionalized spouse’s income is also insufficient to meet the mmmna, some of the couple’s countable income-producing resources may be allocated to the community spouse.79 in summary, if the community spouse’s income is less than the mmmna (the greater of her actual monthly expenses or $2,155 per month), she may keep some of the institutionalized spouse’s income or some of the couple’s income-producing resources to reach the mmmna.80 however, regardless of the community spouse’s actual expenses, the mmmna amount cannot exceed $3,260 per month unless increased by administrative or court orders.81 b. resource eligibility medicaid resource eligibility is determined by evaluating the resources 72. id. § 3455.15.10. 73. lauzon, supra note 43. 74. id. 75. francis et al., supra note 12, at 106. 76. lauzon, supra note 43. 77. spousal impoverishment protection law, supra note 59. 78. lauzon, supra note 43. 79. id. 80. spousal impoverishment protection law, supra note 59; lauzon, supra note 43. 81. lauzon, supra note 43. 464 indiana health law review [vol. 19:455 owned by the institutionalized spouse solely as well as the resources owned by the couple jointly.82 the value of the couple’s resources is determined on the “snapshot date.”83 the snapshot date is the first day of a continuous thirty-day period of the institutionalized spouse’s institutionalization.84 on the snapshot, the couple’s resources are classified as “exempt” or “countable.” only countable resources that are “available” are considered when making the resource eligibility determination in indiana.85 resources are considered available if either spouse “has the right, authority or ability to liquidate the property, or [their] share of the property.”86 generally, the following are countable resources (1) cash;87 (2) bank assets (checking, savings, cds);88 (3) the cash surrender value of life insurance;89 (4) stocks and bonds;90 (5) iras, 401(k)s, 527(b)s, and other tax-deferred accounts owned by the institutionalized spouse;91 (6) pensions and other retirement plans;92 (7) real property (if not exempt in the list below).93 conversely, the following are generally exempt (not counted) resources (1) irrevocable burial and funeral trusts (including those purchased for 82. wone, supra note 6, at 494. 83. lauzon, supra note 43. 84. 42 u.s.c. § 1396r-5(c)(1)(a). 85. see 405 ind. admin. code 2-3-14 (2021). 86. id.; see generally willford v. n.c. hhs, 792 s.e.2d 843 (n.c. ct. app. 2016) (holding that $46,000 held in a workers’ compensation medicare-set-aside account was not a countable resource because the individual legally could not use the funds for purposes other than covering medical expenses arising from the work injury). 87. exempt and non-exempt resources, ind. long term care ins. program, https://www. in.gov/iltcp/2426.htm [https://perma.cc/wg23-skcd] (last visited feb. 15, 2021); ind. fam. & soc. servs admin., ind. health coverage program policy manual § 2615.05.00 (2016), https://www.in.gov/fssa/ompp/files/medicaid_pm_2600.pdf [https://perma.cc/9tjg-kpml] [hereinafter ind. health coverage program policy manual]. 88. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.10.00. 89. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.25.05. 90. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.45.00. 91. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.15.00. 92. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.15.00. 93. exempt and non-exempt resources, supra note 87 (noting capital gains, interest, and dividends received earned by a countable resource are considered countable income). 2022] medicaid: a safety net for the “wealthy” 465 the community spouse, the couple’s children, and the spouses of their children);94 (2) home (there is a cap of $603,000 on the amount of equity the couple or institutionalized spouse can have in the home; however, the equity cap does not apply if the community spouse is still living in the home);95 (3) real property owned solely by the community spouse (no cap);96 (4) income-producing real property (if the income generated is greater than the expense of ownership);97 (5) term life insurance with no cash surrender value;98 (6) iras, 401(k)s, 527(b)s, and other tax-deferred accounts owned by the community spouse;99 (7) personal effects and household furnishings;100 and (8) one vehicle of any value.101 once the couple’s countable resources are determined, one-half of that total is considered the community spouse’s share, and the other half is considered the institutionalized spouse’s share.102 the institutionalized spouse’s share is subject to the medicaid spend-down, meaning his share of resources must be spent down to $2,000 before medicaid will begin coverage of any nursing home expenses.103 the community spouse’s share is known as the “community spouse resource allowance” (csra).104 the community spouse retains the csra without impacting the institutionalized spouse’s eligibility.105 in indiana, the csra must be at least $25, 284 but not more than $126, 420.106 if the countable resources exceed the maximum csra limit, the community spouse’s resources to the extent that they exceed the csra limit are considered available to the 94. id.; francis et al., supra note 12, at 154-55. 95. ind. health coverage program policy manual, supra note 87, § 2620.15.10.06; see also indiana medicaid income & asset limits for nursing homes & in-home long term care, am. council on aging, https://www.medicaidplanningassistance.org/medicaid-eligibility-indiana/ [https://perma.cc/a8bw-7dad] (last updated feb. 1, 2021). 96. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2640.10.15.06. 97. exempt and non-exempt resources, supra note 87. 98. id.; ind. health coverage program policy manual, supra note 87, §§ 2615.25.052615.25.05.20. 99. ind. health coverage program policy manual, supra note 87, § 2615.15.00. 100. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.30.00. 101. exempt and non-exempt resources, supra note 87; ind. health coverage program policy manual, supra note 87, § 2615.60.20.05. 102. lauzon, supra note 43, § 3. 103. spousal impoverishment protection law, supra note 59. 104. lauzon, supra note 43. 105. id. 106. spousal impoverishment protection law, supra note 59. 466 indiana health law review [vol. 19:455 institutional spouse and subject to the spend-down.107 once the institutionalized spouse is deemed eligible for benefits and has been in a nursing home continuously for a thirty-day period, no resources acquired by the community spouse after that time shall be deemed available to the institutionalized spouse.108 b. asset transfer rules & ineligibility penalties the deficit reduction act was signed into law in 2006 to cut medicaid spending by an estimated $10 billion.109 the act most notably tightened the asset transfer rules by imposing a longer, more strenuous “look-back” period.110 the look-back period is a five-year period that begins on the first date on which the institutionalized spouse has applied for medicaid benefits and is institutionalized.111 simply put, the look-back is “the period of time examined to see if an individual has transferred assets for less than fair market value.”112 generally, countable resource transfers by the institutionalized spouse or the community spouse for below fair market value within the look-back period will result in a period of medicaid ineligibility.113 the legislature has not defined “fair market value,” however, the courts have. fair market value is the price at which property would change hands between a willing buyer and seller where neither is under any compulsion to consummate the sale. anything affecting the sale value on the date of the taking is a proper matter for consideration in attempting to arrive at a fair market value. generally, all facts which an ordinarily prudent man would take into account before forming a judgment as to the market value of [the] property he contemplates purchasing are relevant and material.114 once it has been established that a transfer for below fair market value occurred, a penalty is assessed.115 the penalty is expressed in terms of months.116 the 107. lauzon, supra note 43. 108. 42 u.s.c. § 1396r-5(c)(4). 109. deficit reduction act: changes to medicaid, commonwealth fund, https://www. commonwealthfund.org/publications/newsletter-article/deficit-reduction-act-changes-medicaid [https://perma.cc/8k3j-9vr3] (last visited feb. 16, 2021). 110. id. 111. 405 ind. admin. code 2-3-1.1 (2021); see 42 u.s.c. § 1396p(c); see also ind. health coverage program policy manual, supra note 87, § 2640.10.10. 112. deficit reduction act: changes to medicaid, supra note 109. 113. 405 ind. admin. code 2-3-1.1; see 42 u.s.c. § 1396p(c); see also ind. health coverage program policy manual, supra note 87, § 2640.10.10. 114. brown v. ind. fam. & soc. servs. admin., 45 n.e.3d 1233, 1238-39 (ind. ct. app. 2015) (citing southtown props., inc. v. city of ft. wayne, 840 n.e.2d 393, 400 (ind. ct. app. 2006). 115. laura zdychnec, the perilous path to long-term care it’s not really about asset protection, bench & bar. minn. 18, 19 (2013). 116. id.; see also ind. health coverage program policy manual, supra note 87, § 2022] medicaid: a safety net for the “wealthy” 467 number of months the penalty will last is determined by dividing the total uncompensated value of the transfer during the look-back period by the average monthly private pay rate for nursing facilities located within that state.117 in indiana, the family and social services administration establishes the average monthly private pay rate – which is $6,681 for 2020.118 for example, a transfer $53,448 below fair market value would result in a penalty for eight months ($53,448 ÷ $6,681 = 8). so, for the eight months following proof of eligibility, medicaid will not pay for the individual’s long-term care expenses.119 if there are multiple transfers for below fair market value, all transfers are consolidated into one penalty.120 indiana does not have a durational limit on the penalty that may be assessed as a result of transfers below fair market value.121 the ineligibility penalty does not start to run until the applicant is medicaid-eligible and would otherwise be receiving institutionalized long-term care at medicaid’s expense.122 to be clear, not all transfers of resources during the look-back will incur a penalty. for example, no penalty is assessed if the countable resources are transferred for fair market value or adequate compensation.123 additionally, thanks to the spousal impoverishment provisions, there is no penalty for transfers of countable resources made to the community spouse for the community spouse’s sole benefit, even if the transfer exceeds the csra.124 as the next section will highlight, many medicaid planning strategies begin here. medicaid also does not impose a penalty for the transfer of countable resources if the transfer was made exclusively for a purpose other than to qualify for medicaid.125 note that the preceding transfer exception is interpreted quite narrowly on a case-by-case basis based on the applicant’s specific circumstances.126 additionally, limited transfers of resources such as household goods, personal effects, trusts, the applicant’s home, property used in a trade or business, and irrevocable annuities may be allowed subject to resource-and-situation-specific requirements.127 finally, there is no penalty for transfers that occur before the look-back – i.e., transfers made 2640.10.35. 117. see zdychnec, supra note 115; see also ind. health coverage program policy manual, supra note 87, § 2640.10.35. 118. ind. health coverage program policy manual, supra note 51, § 3006.00.00. 119. francis et al., supra note 12, at 133. 120. id. at 148. 121. id. at 150. 122. id. at 148. 123. see 42 u.s.c. § 1396p(c)(2)(c); see also 405 ind. admin. code 2-3-1.1(k)(7)(a) (2021); see generally brown v. indiana family & soc. servs. admin., 45 n.e.3d 1233 (ind. ct. app. 2015) for further discussion of transfers below fair market value. 124. see 42 u.s.c. § 1396p(c)(2)(b)(i); see also 405 ind. admin. code 2-3-1.1(k)(2). 125. 42 u.s.c. § 1396p(c)(2)(c)(ii). note that the individual seeking benefits must make a satisfactory showing to the state that assets were transferred exclusively for a purpose other than to qualify for medicaid. 126. francis et al., supra note 12, at 137. 127. id. at 149-50. 468 indiana health law review [vol. 19:455 more than five years before the medicaid application was submitted.128 v. “repositioning” the wealthy’s assets using medicaid planning the complexity of the medicaid eligibility requirements and the lack of clear, concise, and readily accessible literature make preserving assets and avoiding ineligibility penalties no easy feat for the average elderly. however, medicaid is also an area where foresight and access to good legal advice are rewarded. thus, the wealthy enjoy a considerable advantage over their less wealthy counterparts when preserving assets and avoiding medicaid penalties.129 asset repositioning is a commonly used medicaid planning technique to convert countable resources into excluded, non-countable resources.130 simplified examples include purchasing a new car, making home improvements, prepaying funeral expenses, and paying off debt.131 however, to the wealthy, these simplified examples represent the tip of the medicaid planning iceberg. this section will sample a handful of medicaid planning strategies employed by the wealthy. the examples in this section will follow the wealthy couple, greg and susan. greg is the institutionalized spouse, and susan is the community spouse. greg and susan seek to preserve their wealth while qualifying greg for medicaid long-term care benefits. a common medicaid planning strategy used by wealthy couples is the purchase and transfer of real estate.132 real estate owned solely by the community spouse is an exempt resource, and resource transfers to spouses are exempt transfers.133 this means that countable real estate already owned by a couple jointly can be sheltered when it is transferred to the community spouse solely.134 additionally, a couple can use nonexempt resources (such as cash) to purchase real estate solely in the community spouse’s name.135 after the snapshot date, the community spouse could keep the real estate and use it for her sole benefit; or the community spouse could transfer or sell the real estate without affecting the institutionalized spouse’s eligibility.136 as mentioned previously, indiana has a cap of $603,000 on the amount of equity a medicaid applicant can have in his primary home.137 as long as the individual’s home equity exceeds the cap, he will be ineligible for medicaid benefits.138 however, with a married couple, the home 128. id. at 134-35. 129. miller, supra note 11, at 92. 130. id. at 94. 131. id. 132. see timothy l. takacs & david l. mcguffey, medicaid planning: can it be justified? legal and ethical implications of medicaid planning, 29 wm. mitchell l. rev. 111, 143 (2002). 133. id. at 141. 134. see id.; miller, supra note 11, at 95. 135. francis et al., supra note 12, at 87. 136. miller, supra note 11, at 95. 137. francis et al., supra note 12, at 70. 138. id. 2022] medicaid: a safety net for the “wealthy” 469 equity cap does not apply to the couple’s jointly owned home if the community spouse is still living in the home.139 more alarming, there is no limit on the value or amount of real estate the community spouse may own solely.140 for example, greg could still qualify for medicaid benefits despite susan’s sole ownership of the couple’s $600,000 residence in indiana, susan’s $400,000 condo in florida, and susan’s $500,000 ski chalet in colorado. another method to protect assets is to convert countable resources to incomeproducing real estate. income-producing real estate is also an exempt resource, even if owned by the institutional spouse – the caveat – income generated by the real estate is countable and must be allocated toward the institutionalized spouse’s care.141 the average life expectancy in a nursing home is just over two years,142 so a considerable amount of resources can be protected by sacrificing a relatively small amount of income. indiana does not require the real estate to generate a set amount of income; instead, the real estate qualifies as “income-producing” if it produces income greater than the expenses of ownership (like insurance, repairs, and taxes)143 if the real estate is rented out for less than fair market value, a penalty may be assessed.144 to put this method in context, as one savvy medicaid planning attorney explained, “a couple with a second vacation home could simply rent its own home and claim the rental income as necessary for the [community] spouse’s maintenance needs, converting it into a non-countable resource.”145 the perks of income-producing real estate are further compounded when a couple uses its countable resources to purchase income-producing real estate in the name of the community spouse solely, because not only is the real estate excluded, so is the income generated by the real estate since the community spouse only receives the income.146 for example, imagine greg and susan purchase an apartment building from their son, wilson, for $300,000 and subsequently deed it to susan solely. the apartment building is no longer a countable resource because it is owned by susan, thus reducing the couple’s countable resources enough to make greg eligible for medicaid. after the snapshot date, susan can sell the apartment building back to wilson for $300,000, or she can keep all the rental income generated by the apartment building – either way, susan can keep all the proceeds without disqualifying greg. 139. id. 140. 42 u.s.c. § 1396p(f)(3); indiana medicaid income & asset limits for nursing homes & in-home long term care, supra note 95. 141. francis et al., supra note 12, at 70. 142. david levine & lisa esposito, how to pay for nursing home costs, u.s. news (oct. 15, 2021), https://health.usnews.com/best-nursing-homes/articles/how-to-pay-for-nursing-homecosts. 143. francis et al., supra note 12, at 70; see ind. health coverage program policy manual, supra note 51, § 3420.05.05. 144. francis et al., supra note 12, at 165; 405 ind. admin. code 2-3-1.1(i) (2021); ind. health coverage program policy manual, supra note 87, § 2640.10.25. 145. moses, supra note 4. 146. see 42 u.s.c. § 1396p(f)(3); see 42 u.s.c. § 1396r-5(b)(1). 470 indiana health law review [vol. 19:455 another planning technique involves artificially increasing the amount of the couple’s countable resources before the snapshot date and then reducing the countable assets after the snapshot is taken.147 the higher the countable resources on the snapshot date (while still being under the eligibility threshold), the higher the csra.148 for example, greg and susan have $120,000 of countable resources in addition to owning their home.149 if greg applies for medicaid now, susan’s csra will be $60,000 (half of the couple’s countable resources). however, if they take out a home equity loan of $120,000 before the snapshot date, making the total countable resources $240,000, susan’s csra will be $120,000.150 after the snapshot date, the couple can pay off the home equity loan and thus, allow susan to keep practically all of the couple’s original $120,000 without disqualifying greg.151 on the other hand, greg’s half of the countable resources will have been spent down by paying off the home equity loan. another technique commonly used by individual applicants to pass wealth on to loved ones utilizes non-negotiable promissory notes because promissory notes, loans, and mortgages that are non-negotiable are easily qualified as exempt resources.152 to qualify as an exempt resource, a promissory note must (1) have an actuarially sound repayment term, (2) require payment to be made in equal amounts throughout the term of the note, and (3) must prohibit the balance from being canceled upon the applicant’s death.153 neither the federal statute nor indiana requires a minimum repayment period or a minimum return rate for the promissory note to meet the first requirement of actuarially sound.154 so, as long as the promissory note has a repayment term shorter than the applicant’s life expectancy155 and a reasonable interest rate, the note should be considered compliant.156 for example, greg and susan have countable resources of $200,000 above the maximum allowed csra.157 before greg’s eligibility, susan enters into a loan agreement with wilson where she lends him $200,000, and in 147. miller, supra note 11, at 95-96. 148. francis et al., supra note 12, at 78-80. 149. id. 150. id. 151. francis et al., supra note 12, at 79; miller, supra note 11, at 95-96. 152. see 42 u.s.c. § 1396p(c)(1)(i); see also ind. health coverage program policy manual, supra note 87, § 2615.50.00. 153. 42 u.s.c. § 1396p; ind. health coverage program policy manual, supra note 87, § 2615.50.00. 154. francis et al., supra note 12, at 161. 155. id. the life expectancy table used by the indiana family and social services administration can be found in the ind. health coverage program policy manual, supra note 87, § 2615.50.00. 156. id. consider the irs applicable federal rate when determining a reasonable interest rate. 157. see michael amoruso et al., medicaid planning tool intensive for promissory notes and spousal refusal, nat’l acad. elder l. att’ys 1, 13-15 (2018), https://www.naela.org/404.aspx? aspxer rorpa th = /c u s tom /b sid ocu m en tse lec tor /p ages /docu m en tv iew er . aspx [https://perma.cc/w72d-gv4r]. 2022] medicaid: a safety net for the “wealthy” 471 exchange, he issues her a non-negotiable promissory note. wilson’s promissory note has a 6-month term, an interest rate of 2% per year, and provides for payments to be made in equal amounts on a monthly basis. as a result, the couple’s resources have sufficiently decreased below the csra limit, making greg eligible.158 over the next six months, wilson will pay susan a total of $202,000 ($200,000 x 2% annual interest x 0.5 years = $202,000). because wilson’s payments occur after greg is receiving medicaid benefits, the entire $202,000 susan receives from wilson is exempt income under the spousal impoverishment rules. alarmingly, it appears as if 100% of the spend-down can be avoided by using a non-negotiable promissory alone since federal and state laws are silent on a maximum amount permissible.159 vi. reform proposals numerous proposals have been set forth to rein in the medicaid “loopholes” exploited by medicaid planning; and, more generally, the issue of financing longterm care in america.160 while more radical reform proposals highlighted in this section look to significantly overhaul or repeal the current medicaid program, more moderate proposals look to reduce america’s reliance on medicaid longterm care benefits. for ease of discussion, this section will group reform proposals into generalized categories. during the 2020 democratic presidential primaries, elizabeth warren and bernie sanders proposed to repeal the medicaid program in its entirety and replace it as part of universal healthcare coverage – i.e., “medicare for all.”161 under medicaid for all, the income and eligibility tests associated with medicaid eligibility would be eliminated.162 however, only long-term care services deemed “medically necessary and appropriate” by cms would be covered – with eligibility and provider reimbursement rates left entirely to cms executive discretion.163 moreover, “[s]pending at each nursing home would be capped by law, and private payment for equivalent services by long-term care insurance, life insurance, or personal funds would have been prohibited.”164 the second category of reform proposals looks to discourage expensive nursing home admissions altogether by increasing the support given to family caregivers. more than 17 million americans currently provide some form of longterm care assistance to elderly family members.165 interestingly, in 2013 “[t]he 158. id. at 18. 159. see 42 u.s.c. § 1396p(c)(1)(i); see also ind. health coverage program policy manual, supra note 87, § 2615.50.00. 160. pope, supra note 3, at 5-6. 161. id. at 8. 162. id. 163. id. 164. id. 165. everette james et al., in this next phase of health reform, we cannot overlook long term care, health affairs (mar. 16, 2017), https://www.healthaffairs.org/do/10.1377/hblog 472 indiana health law review [vol. 19:455 congressional budget office[]estimated the value of informal ltc provided [by family caregivers] to be greater than what was then spent on formal care” – $234 billion and $192 billion, respectively.”166 better yet, family caregivers often provide long-term care assistance with little to no cost to public programs like medicaid.167 however, while there is little to no cost on the medicaid program, family caregiving is by no means free. “[t]he cost of family caregiving can be felt in other areas, such as reduction or loss of work productivity or increased risk of illness and injury.”168 president joe biden has previously suggested that providing family caregivers a $5,000 non-refundable tax credit would help ease the financial burden of family caregiving and encourage more families to look after their elderly relatives.169 while a $5,000 non-refundable tax credit is a decent start, it is likely insufficient, considering a 2011 metlife study estimates that leaving the workforce to provide care for an elderly parent costs women an average of $324,044 in lifetime wages and benefits.170 the third category of proposals suggests raising medicaid’s current resource limit or establishing tiered medicaid eligibility and benefits levels.171 this approach is centralized on solving the all but unique predicament where the lower-middle-class members are too rich to qualify for medicaid but too poor to pay for long-term care.172 proponents argue that if the elderly were allowed to leave a modest inheritance for their loved ones or were allowed limited medicaid benefits despite their increased resources, fewer people would engage in asset repositioning.173 these proponents further argue, “[t]he denial of a poor person’s right to leave a modest inheritance to his loved ones at a time when the superwealthy are being excused from paying estate taxes is simply unconscionable.”174 the fourth category of proposals attempts to discourage reliance on medicaid by encouraging more americans to plan and save for long-term care, just as they do for retirement (or as they should be doing for retirement). the possibility of individual medical accounts (“imas”), a variant on the individual retirement account, has been raised.175 proponents argue imas would provide individuals tax advantages to save for long-term care, thus reducing american reliance on 20170316.059218/full/ [https://perma.cc/cen2-wlrx]. 166. pope, supra note 3, at 6. 167. james et al., supra note 165. 168. id. 169. pope, supra note 3, at 8. 170. id. at 6. 171. see miller, supra note 11, at 107; cf. vernon k. smith et al., eliminating the medicaid asset test for families: a review of state experiences, kaiser fam. found. 1, 8 (2001), https:// www.kff.org/wp-content/uploads/2001/04/2239-eliminating-the-medicaid-asset-test.pdf [https://perma.cc/up7x-yrzm]. 172. see generally miller, supra note 11, at 107. 173. id. 174. id. at 107-08. 175. id. at 103. 2022] medicaid: a safety net for the “wealthy” 473 medicaid-financed long-term care.176 however, critics of imas quickly point out that a significant amount of those who do save may never actually need the savings since they will not require long-term care.177 additionally, critics point out that those who are likely to fund imas are the individuals who have the least financial need for them – i.e., the wealthy.178 moreover, many americans are not saving enough for retirement, let alone are enough of them using the taxadvantaged retirement accounts already available to them.179 according to a report published by the federal reserve, nearly a quarter of americans have no retirement savings at all.180 convincing americans to fund imas will undoubtedly be no easy task. the final category of proposals encourages individuals to finance their longterm care using private long-term care insurance. of the proposals mentioned in this section, this category seems to have the most traction. notably, indiana was one of the first four states to implement a creative partnership program to encourage this very goal.181 indiana’s program and partnership programs offered by other states will be discussed more thoroughly in the next section. other than the partnership programs that will be discussed separately in the next section, other strategies to increase the use of private long-term care insurance include “allowing employees to use retirement account funds to pay long-term care insurance premiums without a federal tax penalty[]and encouraging employers to offer long-term care insurance plans to employees….”182 one commentator creatively suggests that an above-the-line tax credit for the total cost of private long-term care premiums would serve as a strong incentive for those who are financially suitable and healthy enough to obtain private long-term care insurance.183 similarly, another commentator suggests that allowing long-term care insurance premiums to be fully deductible would encourage private longterm care insurance ownership, just as the mortgage deduction encourages home buying.184 moreover, encouraging more people to purchase long-term care 176. id. 177. id. 178. id. 179. alicia adamczyk, 25% of us adults have no retirement savings, cnbc (may 24, 2019), https://www.cnbc.com/2019/05/24/25-percent-of-us-adults-have-no-retirement-savings-fedfinds.html [https://perma.cc/5nff-6gcy]. 180. id. 181. what you should know about long term care, ind. long term care ins. program 1, 7 (2017), https://www.in.gov/iltcp/files/2017-6-14-doi-what-you-should-know-booklet.pdf [https://perma.cc/269n-gk4c]. 182. james et al., supra note 165. 183. carol murin, comment to in this next phase of health reform, we cannot overlook long term care, healthaffairs (mar. 16, 2017), https://www.healthaffairs.org/do/10.1377/ hblog20170316.059218/full/ [https://perma.cc/cen2-wlrx]. 184. rick dilaurenzo, comment to in this next phase of health reform, we cannot overlook long term care, healthaffairs (mar. 16, 2017), https://www.healthaffairs.org/do/10.1377/ hblog20170316.059218/full/ [https://perma.cc/cen2-wlrx]. 474 indiana health law review [vol. 19:455 insurance would strengthen the long-term care insurance market, resulting in better long-term care insurance at a better price.185 critics of this category point out that long-term insurance is likely to be purchased by the wealthy, not the middle-class, and certainly not the lower-middle-class in the “too rich, but too poor” predicament, as mentioned previously.186 vii. long-term care partnership programs the deficit reduction act (as discussed supra in section iv) not only sought to place tighter restrictions on asset transfers, it also sought to incentivize americans to purchase private long-term care insurance.187 to do such, the act authorized states to offer unique medicaid asset disregards for individuals who purchase qualified long-term care insurance policies under programs commonly known as “long-term care partnerships programs.”188 as mentioned in the previous section, indiana was one of the first four states (along with california, connecticut, and new york) to pioneer such an innovative long-term care insurance program.189 today, all but five states offer some variation of a longterm care partnership program like indiana’s.190 long-term care partnership programs are a partnership between state governments and private insurance companies, where the insurance companies agree to offer long-term care insurance policies that satisfy more stringent state requirements than traditional private long-term care policies.191 unlike traditional long-term care insurance policies, policies under the long-term care partnership program protect the insured’s assets through a unique medicaid asset protection feature that subjects the insured to alternative, more favorable medicaid eligibility rules.192 if a state adopts a qualified long-term care partnership program, the benefits paid under a qualified long-term care policy create dollar-fordollar protection [or total asset protection] for the insured against such medicaid spend-down requirements. assets previously required to be spent down in order for the individual to be eligible for medicaid coverage are now preserved for the insured or the insured’s estate, to the extent of long-term care benefits paid or payable from the qualified long185. murin, supra note 183; dilaurenzo, supra note 184. 186. miller, supra note 11, at 103, 107. 187. see pope, supra note 3, at 12. 188. long term care insurance partnership plans: added protection ideally suited for middle-income americans, am. ass’n long-term care ins., https://www.aaltci.org/long-termcare-insurance/learn ing-cen ter/ lon g-t e rm -care-insurance-partnersh ip-plans.php [https://perma.cc/r478-p9vy] (last visited feb. 16, 2021). 189. what you should know about long term care, supra note 181. 190. see state partnership programs and reciprocity, n.y. st. partnership long term care, https://nyspltc.health.ny.gov/reciprocitymap.htm [https://perma.cc/ew47-lcxv] (last visited feb. 13, 2021) [hereinafter state partnership programs and reciprocity]. 191. what you should know about long term care, supra note 181. 192. id. at 7-9. 2022] medicaid: a safety net for the “wealthy” 475 term care insurance policy.193 a qualified long-term care policy may provide two basic types of asset protection: dollar-for-dollar protection and total asset protection.194 most states offer dollar-for-dollar protection; however, some states, such as indiana, offer a combination of the two.195 to qualify for total asset protection, a policy must have (1) a minimum state-set daily benefit, (2) a total benefit equal to or more than the state-set minimum for the year the policy is purchased, and (3) a benefit that increases according to the inflation protection percentage set by the state.196 in indiana, a long-term care policy with total asset protection issued in 2021 must have a daily benefit of at least $115, a total policy benefit of at least $430,014, and a compound inflation factor of 5%.197 both types of qualified long-term care policies protect assets from spend-down when the insured applies for medicaid benefits after the policy’s benefits have been exhausted.198 a policy with total asset protection protects all of the individual’s assets regardless of value and regardless of whether the assets are classified as countable under the medicaid eligibility tests.199 on the other hand, a policy with dollar-for-dollar protection provides asset protection equal to the amount paid out in benefits up to the policy maximum.200 now apply indiana’s long-term care partnership program to our institutional spouse, greg, who has $500,000 of countable resources and a qualifying long-term care policy. for the following scenarios, greg’s marital status and the repositioning strategies discussed previously in section v are not relevant. for scenario one, greg’s qualifying long-term care policy has a total benefit of $160,000 with dollar-for-dollar protection. if greg enters a nursing home and uses up his full policy benefits of $160,000, he may need to apply to medicaid to pay for his continuing nursing home care. because greg had a qualifying long-term care policy with dollar-for-dollar protection, medicaid will 193. jamie p. hopkins et al., leveraging filial support laws under the state partnership programs to encourage long-term care insurance, 20 widener l. rev. 165, 185 (2014). 194. frequently asked questions, ind. long term care ins. program (oct. 2009), https://www.in.gov/iltcp/2362.htm [https://perma.cc/3mut-efbe]. 195. aaron skloff, partnership qualified long term care insurance policies, lexisnexis (dec. 12, 2009), https://www.lexisnexis.com/legalnewsroom/estate-elder/b/estate-elder-blog/posts/ partnership-qualified-long-term-care-insurance-policies [https://perma.cc/h8zt-drf4]. 196. frequently asked questions, supra note 194. 197. what you should know about long term care, supra note 181, at 9, 18. long-term care policies issued or renewed in indiana after june 30, 2022 will be subject to new inflation protection requirements that vary depending on the age of the insured when the policy is purchased. individuals younger than 61 must have compound inflation protection; individuals aged 61 to 75 must have some level of inflation protection; and individuals aged 76 or greater may have some level of inflation protection. ind. code § 12-15-39.8-3(5)(a)-(c) (2021). 198. see skloff, supra note 195. 199. frequently asked questions, supra note 194. 200. id. 476 indiana health law review [vol. 19:455 disregard $162,000 of his countable assets ($160,000 of protected assets, which is equal to the insurance benefits used + $2,000 for the standard medicaid resource allowance).201 this means greg will still have to spend down $338,000 of his $500,000 countable assets before medicaid benefits begin. for scenario two, greg’s qualifying long-term care policy has a total benefit of $430,014 with total asset protection. unlike the first scenario, medicaid will now disregard all of greg’s countable assets after greg exhausts his policy’s benefits. this means that greg will not have to spend down any of his $500,000 countable assets before medicaid benefits begin. a final advantage qualifying policies have over traditional policies is that the premiums for qualifying long-term care policies may be deducted from the insured’s state taxes.202 while the prospects of long-term care partnership programs are primarily positive, there are a few drawbacks. first, long-term care insurance does not always provide the same level of coverage as that provided by medicaid provides—for instance, prescription drugs are not often covered by long-term care policies.203 second, despite most states now offering some form of a longterm care partnership program, the asset protection offered in one state may or may not be honored if the insured moves to another state.204 third, as mentioned in the previous section, long-term care insurance is likely to be purchased by the wealthy, not the lower-middle-class.205 finally, many insurance companies require applicants to pass rigorous medical underwriting before providing longterm care insurance coverage.206 while passing the required underwriting may be easy for a young adult in good health, it may be considerably more difficult for a 55-year-old with a preexisting health problem.207 viii. prospective while the proposals to reform medicaid are respectable, they fail to address the ultimate question: how did a program intended for the “needy” turn into an entitlement for the middle-class and wealthy alike? not only does society have a generalized distaste toward using medicaid,208 but purposeful impoverishment to gain medicaid benefits conflicts with the american values of pride, hard work, and self-reliance. so, why are so many americans engaging in medicaid planning? while it is tempting to say the answer is “greed,” a more honest answer may be “fear” – the fear of losing the “american dream” and the fear of being forgotten by loved ones. “the one thing that elderly people fear the most is 201. what you should know about long term care, supra note 181, at 10. 202. id. at 17. 203. id. 204. frequently asked questions, supra note 194; see state partnership programs and reciprocity, supra note 190 (mapping the reciprocity amongst state partnership programs). 205. miller, supra note 11, at 103, 107. 206. see generally what you should know about long term care, supra note 181, at 6. 207. see generally id. 208. miller, supra note 11, at 100, 101. 2022] medicaid: a safety net for the “wealthy” 477 financial impoverishment, with its attendant restrictions on their ability to remain independent and to leave an inheritance to their heirs. furthermore, the greatest single threat to the financial security of the elderly is the cost of long-term care.”209 for many elderly individuals, the assets they have spent a lifetime acquiring and maintaining represent the total sum of their adult lives—their pursuit of the american dream. furthermore, the elderly may view voluntary impoverishment as an honorable sacrifice so that their children, grandchildren, and greatgrandchildren have a better shot at achieving the american dream than they did. beyond the sentimental and societal reasons, maybe leaving an inheritance fulfills a fundamental elderly need—the need not to be forgotten. a man wishes to perpetuate and immortalize himself, as it were, in his great-grandchildren. for middle-class seniors who need long-term care, the present medicaid system is, in effect, a health lottery that deprives them of this opportunity. no rational person would enter such a lottery voluntarily.210 leaving an inheritance for loved ones ensures the elderly will not be forgotten, or so it would seem. after all, why do we work so hard to achieve the american dream only to relinquish its supposed benefits once we get there? “imagine spending a lifetime trying to accumulate wealth, and then the last three years of your life trying to get rid of it so you can get medicaid.”211 while medicaid was intended to be an assistance program exclusively for the “needy,”212 it hardly seems that intention remains today. while some argue that the development of the look-back period, the restriction on the use of certain types of trusts, and the extension of penalty periods, are examples of congressional intent to restrict medicaid to only the needy.213 at face value, the former examples appear to support the congressional intent for medicaid to remain exclusively for the poor. however, if we consider congressional actions and policies on a broader scope, a scope not limited exclusively to the medicaid program, it appears as if congress all but enables the wealthy to engage in medicaid planning. for example, consider the following. congress has increased the estate tax exemption to the point that in 2021 a wealthy couple can leave over to $23 million to their heirs with no estate or gift tax bill.214 moreover, the 209. jeffrey l. soltermann, medicaid and the middle class: should the government pay for everyone’s long-term health care?, 1 elder l.j. 251, 289 (1993). 210. takacs & mcguffey, supra note 132, at 141. 211. teresa wiltz, getting older, going broke: who’s going to pay for long-term care?, pew charitable trust (july 25, 2019), https://www.pewtrusts.org/en/research-and-analysis/ blogs/stateline/2019/07/25/getting-older-going-broke-whos-going-to-pay-for-long-term-care [https://perma.cc/k6au-mslu]. 212. joseph s. karp & sara i. gershbein, poor on paper: an overview of the ethics and morality of medicaid planning, 79 fla. bar j. 61, 64 (2005). 213. id. 214. ashlea ebling, irs announces higher estate and gift tax limits for 2021, forbes (oct. 478 indiana health law review [vol. 19:455 mortgage interest deduction allows the wealthy to deduct mortgage interest for multiple vacation homes.215 finally, the 2020 social security tax is only taxable on $137,700 of income, meaning millionaires and billionaires only paid a measly $8,537.40 in social security tax, although the social security trust fund is slated to run out by 2035.216 at a minimum, these entitlements afforded to the wealthy seem to stand in stark contrast to the imposition that medicaid’s spend-down rules are intended to strip away every last vestige of a person’s inheritance.217 regardless of the restrictions imposed, those with access to good legal counsel will always find creative (and legal) entry into the medicaid system. nevertheless, the most straightforward reform could also be the most effective reform. what if the wealthy were allowed into the medicaid program, but there was a limitation on the duration of benefits or limitations delaying the effective date benefits begin? for example, benefits could be delayed for those with assets above a set threshold for two years. according to the national nursing home survey, the average life expectancy in a nursing home is just over two years.218 moreover, only 15% of nursing home residents receive long-term care for more than two years, and only 2% receive long-term care for more than ten years.219 so, theoretically, this simple proposal may result in a cost decrease to the medicaid program since most of the wealthy will likely end up paying all or a significant portion of their nursing home care before medicaid is obligated to step in. the united states is not the only industrialized country with a growing elderly population in need of expensive long-term care. however, the united states is undoubtedly the outlier on the international stage.220 “while the united states has embarked on efforts to relieve pressure on its means-tested medicaid program by enhancing private insurance, many other industrialized countries have taken a different route.”221 countries such as norway, sweden, denmark, finland, germany, france, japan, korea, and the netherlands have all 26, 2020, 10:22 pm), https://www.forbes.com/sites/ashleaebeling/2020/10/26/irs-announces-higherestate-and-gift-tax-limits-for-2021/?sh=563f3dc9459e [https://perma.cc/fs5u-uccy]. 215. emily badger & christopher ingraham, the rich get government handouts just like the poor. here are 10 of them, wash. post (apr. 9, 2015, 2:12 pm), https://www. washingtonpost.com/news/wonk/wp/2015/04/09/the-rich-get-government-handouts-just-like-thepoor-here-are-10-of-them/ [https://perma.cc/w6k6-ecma]. 216. see hunter kuffel, social security tax limit for 2021, smartasset (dec. 28, 2021), https://smartasset.com/retirement/social-security-tax-limit [https://perma.cc/h3w8-gjjb]. 217. miller, supra note 11, at 99. 218. levine, supra note 142. 219. pope, supra note 3, at 6. 220. joel dodge, the no-brainer case for universal long-term care, people’s pol’y project (july 26, 2018), https://www.peoplespolicyproject.org/2018/07/26/the-no-brainer-case-foruniversal-long-term-care/ [https://perma.cc/s8m2-2kwe]. 221. howard gleckman, the future of long-term care: what is its place in the health reform debate?, urban inst. & brookings inst. tax pol’y ctr. 1, 11 (2009), https://www. taxpolicycenter.org/sites/default/files/alfresco/publication-pdfs/411908-the-future-of-long-termcare-what-is-its-place-in-the-health-reform-debate-.pdf [https://perma.cc/kq9f-rqy4]. 2022] medicaid: a safety net for the “wealthy” 479 implemented government-funded or government-provided long-term care programs.222 “adopting a similar system would bring the united states in line with the rest of the developed world.”223 so, while attempts to restrict the current medicaid system continue to fail, it may be time for the united states to seriously consider implementing some form of a universal long-term care program like that offered by many of its developed peers. ix. conclusion annual medicaid spending is projected to exceed $1 trillion by 2028.224 while longer life expectancies, skyrocketing healthcare costs, and an increasing amount of elderly requiring long-term care are mostly to blame for medicaid’s ever-growing spending, it is easy to overlook the fact that individuals with ample financial means can, and do, take advantage of a welfare program never intended for them.225 while closing the loopholes exploited by the wealthy and their lawyers is undoubtedly a start to reining in medicaid spending, solving the much larger issue of financing long-term care will require complex reform. however, the outlook for reform anytime soon is grim. the deepening political divide, never-ending gridlock, and lack of political courage in washington make it unlikely that any complex reform will occur soon – leaving the status quo: medicaid as the primary payer of long-term care in america. 222. see id.; dodge, supra note 220. 223. dodge, supra note 220. 224. see sean p. keehan et al., national health expenditure projections, 2019–28: expected rebound in prices drives rising spending growth, 39 health affairs 704 (2020), https://www. healthaffairs.org/doi/10.1377/hlthaff.2020.00094 [https://perma.cc/w7y9-rt7v]. 225. pope, supra note 3, at 5. the return on investment of pandemic rental assistance: modeling a rare win-win-win* sam gilman** abstract we are facing an eviction crisis. the covid-19 pandemic has sent our economy into a tailspin, forcing countless americans to choose between feeding their families or having a roof over their heads. many low-income people, especially low-income people of color, are facing an unprecedented economic crisis with tremendous rates of wage reductions and job loss. this has resulted in millions of americans being unable to pay their full rents, creating the legal grounds for their landlords to evict them.1 scholars, policymakers, and advocates have increasingly focused on a number of solutions to the eviction crisis (including eviction moratoria and rental assistance), concluding that these solutions can stabilize households, especially when combined. yet, a counter narrative almost always offers that investing in national rental assistance programs will be expensive. indeed, advocates have estimated that more than $100 billion in funding may be needed.2 however, few analysts have emphasized the financial costs of inaction. this article aims to fill that gap by estimating the return on investment (“roi”) of pandemic-related rental assistance programs by * copyright © 2021, sam gilman. all rights reserved. this article requires an enormous number of thank yous to the village of people who contributed. i owe deep gratitude to jac woo. she painstakingly checked my eviction risk model. she provided heroic efforts to strengthen the model, account for differentials in job and wage losses, and help evaluate rental debt shortfalls. she also helped me problem solve the cost-benefit analysis model. i also owe huge thank yous to steven andrew reid and sam shaffer for respectively providing help on critical components of this model. thanks to zach neumann and the rest of the covid-19 eviction defense project team for the push to continue to produce research to shape the response. neil steinkamp inspired me to take on this project and has helped me shape and frame this analysis from the macro to the micro in weekly check-ins since the beginning of the project. mark fagan created an opportunity for me to work on this project through an independent study at the harvard kennedy school and has guided my writing process. thank you to nicole summers for giving the piece a critical read. thank you to nicole summers, esme caramello, and eloise lawrence for teaching me housing law and informing the essential eviction framing. finally, i am grateful to the indiana health law review and its editors for their thoughtful edits and endless patience. ** sam gilman works at the intersection of law, policy, and systems. he is a co-founder and coo at the covid-19 eviction defense project and a jd/mpp student at harvard university. 1. tabulations of week 20 of the household pulse survey, covid-19 eviction def. project (dec. 16, 2020), https://cedproject.org/2020/12/18/tabulations-of-week-20-of-hh-pulsesurvey/ [https://perma.cc/nlu3-vsm3]. 2. andrew aurand et al., nat’l low income hous. coal., nlihc research note: emergency rental assistance needs for workers struggling due to covid-19 3 (2020), https://nlihc.org/sites/default/files/emergency-rental-assistance-needs-for-workers-strugglingdue-to-covid-19.pdf [https://perma.cc/jhp3-ylv6]. 294 indiana health law review [vol. 18:293 comparing the costs of rental assistance with the social costs of homelessness and displacement. as seen in figure 1, and using end-of-2020 source data, this article estimates that pandemic rental assistance has a positive roi of between 208-466%. these roi values point to the conclusion that failing to invest in rental assistance will cost dramatically more than making the investment now. the roi analysis finds that rental assistance stabilizes both tenants and landlords, preserves neighborhoods, and protects government budgets over the long-term. more broadly, the returns on rental assistance argue for a reimagination of the eviction system. the conclusion that the estimated benefits of rental assistance eclipse the estimated costs of providing the funds by three or four times suggests that rental assistance should supplant eviction as the social remedy for the inability to pay rent. with an investment of rental assistance, nonpayment evictions can forever remain “non-essential” evictions. in short, keeping people in their homes during this pandemic and beyond is not only the right thing to, but it is economically the smart thing to do. figure 1 i. introduction a. background: a financial crises triggers and eviction crisis the covid-19 pandemic has sparked one of the most severe human and economic crises of our lifetime. ten months into the pandemic, the united states economy had ten million fewer jobs—a level surpassing that of the great recession.3 the pandemic’s affect has demonstrated the harsh economic reality 3. jared bernstein & heather boushey, the employment situation in january, white house (feb. 5, 2021), https://www.whitehouse.gov/briefing-room/blog/2021/02/05/the2021] the return on investment of pandemic rental assistance 295 facing low-income households who have unemployment rates nearing 20%.4 black and brown people have been affected financially at significantly higher rates than white people, exacerbating a climate of income inequality.5 and while many men have returned to work, women – and primarily women of color – have not.6 these economic conditions have triggered a housing crisis of historic portions, on top of a preexisting housing crisis.7 tens of millions of americans are now at risk of eviction and displacement. as of mid-december, nearly nineteen million individuals lived in households behind on rent and arrearages are accumulating with each passing month.8 missing a single rent payment in america, particularly during a global pandemic, can trigger a property owner’s right to evict non-paying renters from their homes. in general, if someone gets sick, their car breaks down, or their employer closes their doors, they risk losing their home. this creates a financial spiral that can result in a swift eviction and descent into poverty and homelessness. as matthew desmond writes: an eviction is not merely a consequence of poverty – it is often a cause of poverty.9 evictions have been linked to job loss, difficulty finding future housing, homelessness, chronic illness, poor learning outcomes, generational poverty, diseases of despair, and now death by covid-19.10 it is not just the tenants who lose when they miss rent. landlords experience steep financial losses – more so during the pandemic. according to the national apartment association, landlords who rent affordable housing often collect less than 10% of rental debts.11 and in the end, government pays for many of the employment-situation-in-january/ [https://perma.cc/zw9r-b8r6]. 4. see raj chetty et al., the economic impacts of covid-19: evidence from a new public database using private sector data 3, 25 (nat’l bureau of econ. research, working paper no. 27,431). 5. bernstein & boushey, supra note 3. 6. claire ewing-nelson, another 275,000 women left the labor force in january, nat’l women’s l. ctr. (feb. 2021), https://nwlc.org/wp-content/uploads/2021/02/january-jobs-dayfs.pdf [https://perma.cc/sa24-elve]. 7. see infra part ii.b. 8. see week 21 household pulse survey: december 9 – december 21, u.s. census bureau, https://www.census.gov/data/tables/2020/demo/hhp/hhp21.html [https://perma.cc/f6g6ykqc] (last updated jan. 5, 2021). 9. see, e.g., matthew desmond, evicted: poverty and profit in the american city (2016). 10. see infra part iii (discussing the various financial and physical health consequences of an eviction); see also infra part vii.e (detailing the research into health and welfare consequences of shelter-based homelessness and non-shelter-based displacement). 11. multifamily debt collections: best practices for owners and managers, nat’l apartment ass’n (sept. 2019), https://www.naahq.org/news-publications/units/september2019/article/multifamily-debt-collections-best-practices [https://perma.cc/gg38-6h4v]. 296 indiana health law review [vol. 18:293 downstream consequences of eviction, including housing and services for the unhoused, health care for low-income individuals, unemployment benefits, foster care for children whose parents do not have a safe home, foreclosure when a landlord cannot sustain their home, and many other costs. b. asking the financial question by january 2021, americans had accrued an estimated $24-$57 billion in rental and utility debts.12 by june, those debts are estimated to climb to approximately $45-60 billion, accounting for federal rental assistance alone.13 by the end of the year, shortfalls for rental assistance could reach over $120 billion. from a human perspective, it is clear that a rental assistance program that pays peoples’ rents and avoids eviction would be worth the investment, warding off the life-altering and life-threatening consequences of displacement, eviction, and homelessness. it would also make landlords whole or close to it. but from a financial perspective, the question is: how much would a rental assistance safety net cost? and would it pay for itself? if the answer to the latter question is yes, advocates can make a compelling case for a comprehensive eviction prevention and rental assistance program that ensures no household is evicted for non-payment of rent or without “good” or “just” cause during the pandemic and recovery.14 under this regime, we can retain the standard identified in massachusetts’ eviction moratorium, defining “non-payment of rent,” no-fault evictions, and for cause evictions that do not threaten health and safety as “nonessential eviction[s].”15 this article was motivated by an effort to answer that financial question. it provides a directional estimated roi for three rental assistance programs. it evaluates: (1) a program structured similarly to the emergency rental assistance program in the consolidated appropriations act; (2) a more expansive federal rental assistance program; and (3) the expansive program including partial rental debt settlements. c. methodology this article presents a directional cost-benefit analysis that estimates the social value of each dollar invested in rental assistance, closely mirroring the methodology of stout risius ross’s (“stout”) cost-benefit-analyses of right-tocounsel efforts in new york, baltimore, los angeles, and philadelphia.16 in each 12. see infra part ii.c (referencing three estimates for rental debts, including moody's analytics; stout risius ross; and this model from the covid-19 eviction defense project). 13. see id. 14. “just cause” statutes limit the grounds upon which landlords can evict tenants, often including property damage, major lease violations, and non-payment. see, e.g., n.j. stat. ann. § 2a:18-61.1 (west 2021); d.c. code § 42-3505.01 (2021). 15. see 2020 mass. acts 65. 16. see generally stout risius ross, inc., the financial cost and benefits of establishing a right to counsel in eviction proceedings under intro 214-a (2016), 2021] the return on investment of pandemic rental assistance 297 geography, these studies evaluate the relative benefits of right-to-counsel programs, meaning a right to legal representation in eviction cases.17 following the stout approach, this article estimates the number of formal and informal evictions reduced by rental assistance programs. for each modeled program, it multiplied these estimates of eviction risk by (a) the estimated perindividual cost of the rental assistance program and (b) compared these costs to those that government and society would not pay due to the avoided eviction. this cost-benefit analysis establishes a directional quantified roi that includes estimates of the public costs and social costs that are avoided due to the intervention. public costs are those that governments pay as a result of eviction. social cost estimates supplement public costs with additional private costs that accrue to society. for example, the total social cost includes the public costs as well as broader neighborhood, landlord, and employment costs. it is worth noting that the roi modeling has several important limitations. first, the analysis is built-off of estimates of displacement risk and economic recovery during the pandemic where there are few good data sources and even fewer historical analogs. second, the model uses data from a period in which limited financial assistance was available to struggling families, but it does not take into account the interaction between rental assistance and other interventions like cash payments. third, this analysis is severely limited by insufficient data on the outcomes of eviction and displacement. it, therefore, is likely to understate the costs avoided by evictions that did not happen. fourth, fifty-state data is subject to enormous national variability and fluctuations in weekly household pulse survey data.18 these limitations point to the need for future experimental and empirical research on the impacts of rental assistance. future studies should apply experimental methods to understand the effects of rental assistance on eviction, displacement, shelter use, rehousing, and all of the costs associated with each of those outcomes in different geographies. this article aims to provide an outline https://cdn2.hubspot.net/hubfs/4408380/pdf/cost-benefit-impact-studies/srr%20report%20%20eviction%20right%20to%20counsel%20%203%2016%2016.pdf [https://perma.cc/456d4glh]. 17. see generally id. the authors estimate the roi of the right-to-counsel in each respective city by comparing the costs of the program with the public costs avoided due to incremental reductions in evictions. these studies have three primary building blocks: (1) the number of evictions reduced by legal representation, which sets the multiplier, (2) the all-in costs of providing attorneys, and (3) the public costs avoided from reducing evictions. social benefit measures are calculated by estimating the cost of a given intervention and accounting only for the portion of the costs avoided that can be attributable to the intervention according to academic studies. 18. it is further limited in a number of instances where no fifty-state analysis exists. for example, in some cities and states, the convention is for renters seeking new housing to have to pay first-months, last-months and security deposit. in others, renters must only pay first months’ rent and security deposit. this type of variability could not be accounted for. conservative assumptions were chosen to limit the risk of overestimate. 298 indiana health law review [vol. 18:293 of the scope of such an analysis and makes the case that experimental data on the role of rental assistance is essential to making the definitive case that rental assistance programs are high-roi interventions. d. roadmap the remainder of this article consists of six parts. part ii quantifies the eviction and rental debt crisis, synthesizing available research and presenting new numbers from the aspen institute-cedp eviction risk model. part iii outlines the consequences of evictions for renters, landlords, and the broader housing market. part iv details the proposed solutions to the housing crisis, including eviction moratoria and rental assistance. part v presents the quantified roi analysis for federal rental assistance. part vi sets forth a reimagination of the eviction-industrial complex. it posits that housing stabilization through rental assistance should supplant eviction as the primary social remedy for non-payment of rent. while landlords should retain the right to evict for “just cause” and even chronic non-payment of rent (where rental assistance cannot sustain the tenancy), this research suggests that all parties would be better off with a strengthened housing safety net. such policies would more appropriately balance tenants’ right to housing and landlords’ ability to earn income from their properties. part vii presents a detailed methodological appendix. ii. quantifying the eviction and rental debt crisis a. background: preexisting housing crisis the covid-19 virus attacked an american rental economy that was already enduring a deep housing affordability crisis. nearly half of american renters were cost burdened, paying more than 30% of their incomes on rent in 2019.19 a quarter of renters were severely cost burdened, paying more than 50% of their incomes on rent.20 more than half a million americans experienced homelessness—either living on the streets or in emergency shelters.21 according to the national low income housing coalition’s out of reach report, “modest rental housing is out of reach for every worker in the bottom half of the wage distribution.”22 it also has a disproportionate effect on renters of color.23 19. joint ctr. for hous. studies of harvard univ., america’s rental housing 2020, at 5 (2020), https://www.jchs.harvard.edu/sites/default/files/harvard_jchs_americas_rental_ housing_2020.pdf [https://perma.cc/8feb-lpdx] 20. id. 21. see u.s. dep’t. of hous. & urban dev., the 2019 annual homeless assessment report (ahar) to congress part 1: point-in-time estimates of homelessness 8 (2020), h t tps:/ /www.huduser.gov/portal/sites/de fau lt / f i le s /pdf /2 0 1 9 -ahar-part-1 .pdf [https://perma.cc/hty2-42dw]. 22. andrew aurand et al., out of reach: the high cost of housing 5 (2020), https://reports.nlihc.org/sites/default/files/oor/oor_2020.pdf [https://perma.cc/g4mu-dxhu]. 23. chester hartman & david robinson, evictions: the hidden housing problem, 14 2021] the return on investment of pandemic rental assistance 299 according to 2020 research by the massachusetts institute of technology and city life/vida urbana, 70% of boston’s market-rate evictions were filed in census tracts where the majority of residents are people of color despite accounting for only half of the city’s rental housing.24 due to the rental affordability crisis, the united states was already in the midst of a crisis of mass eviction and displacement when the pandemic hit. studies estimate that more than 70% of evictions occur due to non-payment of rent.25 on average, landlords file 3.6 million eviction cases per year according to the eviction lab.26 a matthew desmond and tracey schollenberger study in milwaukee found that for every formal eviction that led to forced displacement there were an additional two households that left their homes due to informal evictions.27 b. eviction risk in the pandemic according to the urban institute, more than 20 million individuals live in renter households who suffered a covid-19 related job loss.28 the median income of a renter household is $40,531,29 and nearly 40% of workers making under $40,000 a year lost their job in the initial stages of the pandemic.30 as seen housing pol’y debate 461, 467 (2003). 24. david robinson & justin steil, evictions in boston: the disproportionate effects of forced moves on communities of color 8 (2020), https://d3n8a8pro7vhmx. cloudfront.net/themes/5eee7e564445ea4f9a6f3080/attachments/original/1592786979/evictionr eport_final_spreads.pdf?1592786979 [https://perma.cc/b9zb-qvxr]. 25. see, e.g., chris salviati, rental insecurity: the threat of evictions to america’s renters, apartment list (oct. 20, 2017), https://www.apartmentlist.com/research/rental-insecurity-thethreat-of-evictions-to-americas-renters#fn-4 [https://perma.cc/mrb7-34pz]; see generally robert collinson & davin reed, the effects of evictions on low-income households (oct. 2018) (unpublished manuscript), https://economics.nd.edu/assets/303258/jmp_rcollinson_1_.pdf [https://perma.cc/w4bq-2tjp]. 26. national estimates: eviction in america, eviction lab (may 11, 2018), https:// evictionlab.org/national-estimates/ [https://perma.cc/9v2t-ahlb]. 27. matthew desmond & tracey schollenberger, forced displacement from rental housing: prevalence and neighborhood consequences, 52 demography 1751, 1761 (2015). 28. see sarah strochak et al., how much assistance is needed to support renters through the covid-19 crisis? (2020), https://www.urban.org/sites/default/files/publication/ 102389/how-much-assistance-is-needed-to-support-renters_1_1.pdf [https://perma.cc/5ajakxh9]. 29. median household income the past 12 months (in 2018 inflation-adjusted dollars) by tenure, u.s. census bureau, https://data.census.gov/cedsci/table?y=2018&tid=acsdt1y2018. b25119&t=income%20and%20poverty%3aowner%2frenter%20%28tenure%29&hideprevi ew=true&vintage=2018&g=0100000us&moe=false [https://perma.cc/dj55-9tpl] (last visited feb. 25, 2021). 30. see also bd. of governors of the fed. reserve sys., report on the economic 300 indiana health law review [vol. 18:293 in figure 2, data from harvard’s opportunity insights recovery tracker program indicates that the recovery has been painfully slow for the bottom quartile of renters. as of this writing, employment rates were 21% below pre-pandemic levels for the bottom quartile.31 research shows that the same households that were hard hit by the pandemic were already suffering from housing insecurity. while some of the economy has recovered, the recovery has been slowest to reach low-income renters who disproportionately work in low-wage and service industry jobs.32 figure 2: percent change in employment by wage quartile33 well-being of u.s. households in 2019, featuring supplemental data from april 2020, at 53 (2020), https://www.federalreserve.gov/publications/files/2019-report-economic-well-beingus-households-202005.pdf [https://perma.cc/d4yf-6gcr]; see also full transcript: fed chair jerome powell’s 60 minutes interview on economic recovery from the coronavirus pandemic, cbs news (may 17, 2020), https://www.cbsnews.com/news/full-transcript-fed-chair-jeromepowell-60-minutes -in t e rv iew -econ om ic-recovery-f rom-coronavirus-pandemic/ [https://perma.cc/gzd7-pvaa]. 31. see chetty et al., supra note 4. 32. jeremy hobson, economist joseph stiglitz: recession will hurt low-income people more than the wealthy, wbur (oct. 9, 2020), https://www.wbur.org/hereandnow/2020/10/09/ joseph-stiglitz-economic-recovery [https://perma.cc/7y6h-8zst]. 33. opportunity insights econ. tracker, https://tracktherecovery.org/ [https://perma.cc/ ejn6-zebs] (last visited feb. 26, 2021). 2021] the return on investment of pandemic rental assistance 301 this economic crisis has placed tens of millions at risk of eviction. last august, an aspen institute analysis leveraged census bureau data and estimated that between thirty to forty million americans could be at risk of eviction by the end of 2020, as seen in figure 3.34 this estimate drew on two independent analyses, one by this author and a team at aspen and the covid-19 eviction defense project35 and another by stout.36 figure 3 as the pandemic surged, a patchwork of eviction moratoria protected millions of renter households from eviction nationwide during 2020.37 in addition to fortythree state eviction orders, federal eviction protections had the effect of depressing eviction filings during the summer and keeping tenants in their homes.38 by the end of the summer, when protections began to lapse, eviction filings reached up to four times their historical weekly averages according to data from the eviction lab.39 34. emily benfer et al., the covid-19 eviction crisis: an estimated 30-40 million people in america are at risk, aspen inst. (aug. 7, 2020), https://www.aspeninstitute.org/blog-posts/thecovid-19-eviction-crisis-an-estimated-30-40-million-people-in -america-are-at-r isk/ [https://perma.cc/9a24-7cew] [hereinafter the covid-19 eviction crisis]. 35. katherine lucas mckay et al., national eviction risk projections, aspen inst. (aug. 10, 2020), https://www.aspeninstitute.org/publications/national-eviction-risk-projections/ [https:// perma.cc/7z2p-ykat]. 36. see the covid-19 eviction crisis, supra note 34. 37. emily benfer et al., eviction, health inequity, and the spread of covid-19: housing policy as a primary pandemic mitigation strategy, 98 j. urb. health 1, 11 (2021). 38. id. 39. eviction tracking system, eviction lab, https://evictionlab.org/eviction-tracking 302 indiana health law review [vol. 18:293 in september, the federal government again stepped in to prevent some evictions. the centers for disease control and prevention (“cdc”) issued a moratorium on evictions for renters who attest to economic hardship during covid-19, meet certain income qualifications, and affirmatively declare their right to protection reprieve from eviction.40 a number of other states had issued more comprehensive eviction protections that have supplemented the cdc moratorium.41 additionally, the federal government, states, and localities allocated hundreds of millions of dollars for rental assistance in 2020. the national low income housing coalition estimates that approximately $4 billion was allocated towards rental assistance in 2020 with the majority coming from the coronavirus relief fund.42 these policies had significant, but incomplete effects. for example, the cdc moratorium had a strong effect initially, but its effectiveness waned. after the cdc order, filings dropped below weekly averages, bottoming out at 83% of historical averages.43 in massachusetts, which formerly had the strongest moratorium in the nation, eviction filing rates returned to pre-pandemic levels in november.44 overall, the eviction lab’s tracker illustrates the fact that evictions and displacements have been slowed, but not stopped by these protections with wide variability by state.45 as of mid-february 2021, nearly 250,000 evictions had been filed in the five states and twenty-seven cities tracked by the eviction lab.46 and, eviction risk prevails despite the existence of moratoria, as increasing numbers of renters are behind on rent. the august projections were not far off.47 in other words, as seen in figure 4, 18% of renters, nineteen million individuals in eight million households, were at risk of eviction for non-payment of rent in january. up to thirty-three million americans in fourteen million households had low confidence in their ability to pay. specifically, housing insecurity disproportionately impacts black and brown [https://perma.cc/5hl4-6vmu] (last visited feb. 26, 2021). 40. see temporary halt in residential evictions to prevent the further spread of covid-19, 85 fed. reg. 55,292 (sept. 4, 2020). 41. see, e.g., colo. exec. order no. d 2020 227 (oct. 21, 2020). 42. rebecca yae et al., nat’l low income hous. coal., nlihc research note: emergency rental assistance programs in response to covid-19 1, 5 (2020), ht tps:/ /n lihc.org/sites/defau lt /f iles/emergency-rental-assistance-programs-3.pdf [https://perma.cc/8mcy-qddn]. 43. see eviction tracking system, supra note 39. 44. mass. trial court dep’t of research & planning, all residential eviction cases, nonpayment of rent, tableau pub., https://public.tableau.com/profile/drap4687#!/vizhome/ massachusettstrialcourtsummaryprocess/summaryprocess [https://perma.cc/h7yn-m8cr] (last visited feb. 23, 2021). 45. see eviction tracking system, supra note 39. 46. id. 47. the covid-19 eviction crisis, supra note 34; week 21 household pulse survey: december 9 – december 21, supra note 8. 2021] the return on investment of pandemic rental assistance 303 households and families with children.48 as figure 5 depicts, black and latine households were more than twice as likely to be behind on rent as white households. a similar ratio holds for households with children compared to households without children. figure 4 figure 5 as noted above, actual eviction filings and rates of displacement may trail and will ideally never reach risk projections, however, collectively, they paint a picture of systemic risk in the rental housing market and a staggering amount of 48. week 21 household pulse survey: december 9 – december 21, supra note 8. 304 indiana health law review [vol. 18:293 potential suffering. without further protection, in the form of eviction moratoria and rental assistance, this eviction storm is projected to make landfall across the country. c. systemic housing market risk: rental debts threaten tenants, government, and landlords alike even if moratoria are in place, many renters are accumulating massive rental and utility debts. given that evictions are the legal response to non-payment of rent, the presence of these debts puts renters at risk of eviction and landlords at risk of foreclosure.49 the accumulation of rental and utility debt represents systemic risk in the housing market: if tenants cannot pay their rent, landlords—particularly mom-and-pop landlords—cannot pay their mortgages, increasing the prevalence of foreclosure for landlords and cascading effects in neighborhoods across the country.50 historically, landlords moved to evict tenants when they fell behind on rent, often for arrearages of less than $600 and primarily for amounts less than $3,000.51 the pandemic has not only created conditions for more renters to fall behind on rent, but it has also deepened rental debts. early 2021 projections of rental debt placed the outstanding amount between $24 billion52 and $57 billion53 by january 2021. stout estimated that renters could accumulate between $13 billion and $24 billion in rental arrears by january.54 mark zandi at moody’s analytics estimated that, 10.2 million renters would owe $57.3 billion in rent and utilities through january for an average of $5,586 per renter.55 49. see, e.g., colo. rev. stat. § 13-40-101 (2021). 50. see, e.g., whitney airgood-obrycki & alexander hermann, covid-19 rent shortfalls in small buildings, joint ctr. for housing stud. harv. u. (may 26, 2020), https://www. jchs.harvard.edu/blog/covid-19-rent-shortfalls-in-small-buildings/ [https://perma.cc/uw7r-jlu6]. 51. emily badger, many renters who face eviction owe less than $600, n.y. times (dec. 12, 2019), https://www.nytimes.com/2019/12/12/upshot/eviction-prevention-solutions-government. html [https://perma.cc/7fx9-69s5]. 52. estimation of households experiencing rental shortfall and potentially facing eviction, stout risius ross, https://app.powerbi.com/view?r=eyjrijoinzrhyjg2nzatmge1mc00nmnjl tllotmtyjm2njfmota4zjmyiiwidci6ijc5mgjmnjk2lte3ndytnge4os1hzji0ltc4zge 5y2rhzge2msisimmiojn9 [https://perma.cc/5tkn-trcn] (last visited feb. 23, 2021). 53. will packer, struggling rental market could usher in next american housing crisis, wall st. j. (oct. 27, 2020), https://www.wsj.com/articles/struggling-rental-market-could-usher-innext-american-housing-crisis-11603791000 [https://perma.cc/9anx-lsfp]. 54. id. 55. jim parrott & mark zandi, averting an eviction crisis 3 (2021), https://www. moodysanalytics.com/-/media/article/2021/averting-an-eviction-crisis.pdf [https://perma.cc/erv584lu]. 2021] the return on investment of pandemic rental assistance 305 figure 6 the covid-19 eviction defense project’s (cedp) january model’s estimates fall in the middle of the range.56 the model projected $34 billion in rental and utility arrears by january 2020.57 the number of renters estimated to be in arrears is up two percentage points and almost 27% from august.58 according to the federal reserve bank of philadelphia, the country has seen a 70% increase in the percentage of people using credit cards to pay rent in november;59 42% of renters did not use regular income sources to pay for necessities during the week prior to the survey period, including 66% of those behind on rent. as liquidity dried up in a worsening economy, families and friends have less money available to support each other, landlords ran out of resources to sustain tenancies, and the debt crisis continued to deepen. without further intervention, and economic recovery, rental shortfalls will continue to accumulate. mark zandi and jim parrott at moody’s analytics estimated that rental arrears debts would reach $43 billion by june, accounting for $25 billion in rental assistance in the consolidated appropriations act of 2021.60 total arrears would be above $68 billion without those funds. as seen in figure 7, cedp estimated a rental and utility shortfall of $85 billion by the end of june 2021, without accounting for the emergency rental 56. see infra part vii (describing how calculations were made). 57. id. 58. tabulations of week 20 of the household pulse survey, supra note 1. 59. chris arnold, more americans pay rent on credit cards as lawmakers fail to pass relief bill, npr (nov. 30, 2020), https://www.npr.org/2020/11/30/938867270/more-americanspay-rent-on-credit-cards-as-lawmakers-fail-to-pass-relief-bill [https://perma.cc/v6x7-937e]. 60. parrott & zandi, supra note 55. 306 indiana health law review [vol. 18:293 assistance payments in the consolidated appropriations act.61 the shortfall would project to be $60 billion with full implementation by june. the model projected a shortfall of $148 billion by december 2021 or $123 billion, assuming full implementation of consolidated appropriations act rental assistance payments. these figures exclude additional federal assistance and assume a gradual economic recovery and that tenants pay the same monthly rent in 2020 as 2021.62 accounting only for tenants who make 80% area median income (“ami”) or less, the model projects a shortfall of $61 billion in june and $105 billion by the end of the year. figure 7 iii. the consequences of an eviction crisis evictions do tremendous harm to individuals and families, particularly during the pandemic. if there is no action to mitigate the effects of these crises, more than twenty-five million people in more than ten million families could be at risk of trauma: extended homelessness, food insecurity, covid-19 contraction, exacerbated health issues, lack of school,63 and even deaths of despair.64 failure to contain the eviction risk increases the likelihood of severe covid-19 spread, as social distancing and good hygiene are much harder for people living in temporary residences, shelters, and on the street.65 61. it is difficult to estimate rental debts into the future, especially in the absence of a federal eviction moratoria and in the presence of an improving economy, as evictions stop the accumulation of rental debt. for that reason, the cedp model estimates rental shortfall – the amount of rent that should be paid for tenants at risk of eviction in 2021 assuming no evictions. 62. see infra part vii (discussing the difference in methodologies between mark zandi and cedp). 63. see, e.g., desmond, supra note 10; matthew desmond & carl gershenson, housing and employment insecurity among the working poor, 63 soc. probs. 46 (2016); collinson & reed, supra note 25. 64. see katherine a. fowler et al., increase in suicides associated with home eviction and foreclosure during the us housing crisis: findings from 16 national violent death reporting system states, 2005–2010, 105.2 am. j. pub. health 311 (2015). 65. lynn jolicouer, coronavirus testing in boston’s homeless community shows shelter size and density matter, wbur (may 15, 2020), https://www.wbur.org/commonhealth/2020/ 2021] the return on investment of pandemic rental assistance 307 as emily benfer, a law professor and leading expert on evictions, and her coauthors document in a recent paper, evictions are associated with numerous physical and mental health conditions, negative health outcomes for women (including domestic violence, negative outcomes for children), and additional sub-standard living conditions when families move.66 and as matthew desmond often highlights, evictions can often be causes in addition to consequences of poverty and lead to negative employment outcomes.67 they also often force renters to move into lower quality housing and neighborhoods with worse conditions, including crime, poverty, and declining housing stock. additionally, evictions create a “scarlet e” that increases the costs of housing and lowers access to high quality housing for tenants who are screened out based on their eviction history.68 moreover, experimental and simulation studies have directly tied eviction to increased incidences of covid-19 and covid-19 deaths. in a different paper, benfer and her co-authors found that states that lifted moratoria during the pandemic experienced statistically significant increases in incidences of covid19 and mortality due to covid-19, controlling for major state fixed effects and interventions.69 they found that lifting moratoria accounted for hundreds of thousands of excess cases and more than ten thousand excess deaths.70 researchers at the national bureau of economic research found, for example, that if comprehensive bans on evictions had been in place throughout the pandemic, the intervention would likely have reduced infections by 14.2% and deaths by 40.7%.71 for mom-and-pop landlords, unpaid rent and evictions mean lost income, unpaid mortgages, and unpaid property taxes. these impacts can also lead to income loss and similar traumatic effects for mom-and-pop landlords and their families, as with renters. according to an analysis from the harvard joint center for housing studies, renters and owners of small properties are disproportionately likely to face covid-19 related economic hardship.72 more than half of the renters with jobs that were at risk in the pandemic live in single-family or two to 05/15/boston-homeless-coronavirus-testing [https://perma.cc/2ft6-mfpw]. 66. benfer et al., supra note 37, at 8; see infra part vii. 67. desmond, supra note 9; desmond & gershenson, supra note 63. 68. see the scarlet e, wnyc studios (june 6, 2019), https://www.wnycstudios. org/podcasts/otm/scarlet-e-unmasking-americas-eviction-crisis [https://perma.cc/7q6y-av5u]. 69. kathryn m. leifheit et al., expiring eviction moratoriums and covid-19 incidence and mortality 3-4 (nov. 30, 2020) (unpublished manuscript) (on file with the indiana health law review) 70. id. at 5. 71. see kay jowers et al., housing precarity & the covid-19 pandemic: impacts of utility disconnection and eviction moratoria on infections and deaths across us counties 1 (nat’l bureau of econ. research, working paper no. 28,394). 72. airgood-obrycki & hermann, supra note 50. 308 indiana health law review [vol. 18:293 four unit homes.73 these homes represent the majority of the naturally occurring affordable housing stock, and roughly 75% of these properties are owned by mom-and-pop landlords who rely on this rental income to pay their mortgages and property taxes.74 financial difficulty among small landlords could destabilize naturally occurring affordable housing and lead to a greater cycle of evictions. a similar cycle emerged after the great recession. at that time, many single-family homes were purchased by private equity firms in foreclosure sales and turned into rental properties run by management companies. these corporate landlords are incentivized to maximize profits using two levers: increasing rents and fees (revenues) and limiting costs like unpaid rents and maintenance.75 evidence from the last decade suggests that these landlords have become some of the most efficient evictors and absentee landlords in the united states. a federal reserve bank of atlanta study in 2016 found that large private equity firms filed evictions on a third of their properties in the year, and they had an 18% higher housing instability rate, controlling for property and neighborhood characteristics. it is also worth highlighting that black residents of atlanta were evicted at the highest rates. in other words, private equity ownership is itself associated with a higher housing instability rate that disproportionately impacted black and brown communities.76 the larger the 2020 eviction and foreclosure crisis, the more properties available for private purchase. iv. proposed solutions to the covid-19 eviction crisis eviction prevention policy primarily aims to keep people in their homes or, if necessary, provide those who must move adequate time and resources to move safely to new homes. there are two types of policy solutions to any eviction crisis: legal measures to prevent shortand medium-term displacement (or reduce the disruption or displacement) and cash assistance to stabilize tenancies. of course, this typology is not binary. legal representation coupled with favorable landlord-tenant laws can often have the effect of stabilizing households. conversely, except for long-term rental subsidies that are effectively permanent, emergency rental assistance may merely minimize the disruption of an eviction. legal measures might include providing access to mediation services, access to counsel, and process changes to lengthen the eviction timeline. cash assistance 73. id. 74. id. 75. see, e.g., michelle conlin, spiders, sewage and a flurry of fees – the other side of renting a house from wall street, reuters (july 27, 2018), https://www.reuters.com/investigates/ special-report/usa-housing-invitation/ [https://perma.cc/t7dz-tb7f]. 76. see generally elora raymond et al., fed. reserve bank of atlanta, corporate landlords, institutional investors, and displacement: eviction rates in single family rentals (2016), https://www.frbatlanta.org/-/media/documents/community-development/ publications/discussion-papers/2016/04-corporate-landlords-institutional-investors-anddisplacement-2016-12-21.pdf [https://perma.cc/a87w-mlf9]. 2021] the return on investment of pandemic rental assistance 309 can come in many forms and may also include measures like the cancellation of rent or rental debt or the conversion of rental debts into non-evictable civil debts. the former buy renters time in their homes and the latter cure rental arrears, addressing the root cause of potential evictions. the two most prominent versions of these policies during the pandemic have been eviction moratoria and rental assistance given their ability to operate at scale. if implemented effectively and in tandem, eviction moratoria and rental assistance are mutually reinforcing.77 moratoria keep tenants in their homes for a defined period of time, and rental assistance can permanently “cure” the risk of eviction by clearing tenant debts and paying future rents for enough time to allow tenants to stabilize. as the sections below will document, not all moratoria and rental assistance policies are created equal. policy design has a tremendous impact on whether the policies actually stabilize tenancies. a. legal measures to prevent displacement the federal government, and states in the absence of federal action, can pass a number of eviction moratoria and housing security policies to buy renters and landlords time. four policies necessitate a special mention: eviction moratoria, foreclosure protections, civil right to counsel, and civil debt conversion. 1. eviction protections the most successful moratoria prevent the initiation of the eviction process and, therefore, bar hearings and execution.78 this policy design places the burden on landlords to comply with the moratoria rather than require tenants to affirmatively declare that they are covered as is the case under the cdc moratorium.79 of course, in rare circumstances landlords may need to pursue an “essential” eviction for conduct that endangers public safety, but eviction moratorium language should carefully limit this type of exception to ensure that it avoids all non-essential evictions for non-payment of rent, no cause, and minor lease violations.80 massachusetts eviction data demonstrates the difference between a policy that 77. see, e.g., zach neumann et al., emerging best practices for covid-19 emergency rental assistance programs 11 (2020), https://www.aspeninstitute.org/wpcontent/uploads/2020/12/aspen-cedp-rental-assistance-presentation.pdf [https://perma.cc/4pb85mxe] (discussing the effective implementation of rental assistance and the mutually reinforcing nature of rental assistance and eviction moratoria). 78. see, e.g., figure 8 (providing data for the number of eviction filings in massachusetts during the state moratorium); see also 2020 mass. acts. 65. 79. compare 2020 mass. acts 65, with temporary halt in residential evictions to prevent the further spread of covid-19, 85 fed. reg. 55,292, 55,292-97 (sept. 4, 2020). 80. see, e.g., 2020 mass. acts 65; see also colo. rev. stat. § 13-40-107.5 (2021). 310 indiana health law review [vol. 18:293 bars the initiation of evictions and one that places the burden on tenants.81 as figure 8 illustrates, between april and october 2020, the state barred eviction filings except in public safety cases, resulting in only sixty-four cases in august 2020.82 in mid-october the state’s moratorium lapsed, and landlords could once again file eviction cases.83 after the state moratorium lapsed, filing returned to pre-pandemic levels.84 under the cdc moratorium, massachusetts residents can prevent the execution of an eviction order, but they cannot stop the filing process. filings dipped again in january and february 2021, perhaps, in part, due to legislation signed on january 2nd that prevents eviction for anyone awaiting rental assistance payments from the state agency.85 figure 8 2. foreclosure protections to ensure the stability of the housing market, foreclosure protections for landlords can accompany eviction moratoria.86 because many mom-and-pop landlords will not be able to make mortgage payments or pay property taxes when tenants are unable to pay rent, housing security legislation should mandate that lenders offer a forbearance option to borrowers unable to make mortgage 81. mass. trial court dep’t of research & planning, supra note 44. 82. id. 83. massachusetts attorney general issues advisory to inform tenants of their rights during covid-19 pandemic, wwlp (jan. 7, 2021), https://www.wwlp.com/news/massachusetts/ massachusetts-attorney-general-issues-advisory-to-inform-tenants-of-their-rights-during-covid-19pandemic/ [https://perma.cc/ar6t-8qdl]. 84. mass. trial court dep’t of research & planning, supra note 44. 85. 2020 mass. acts 257. 86. see, e.g., coronavirus aid, relief, and economic security act, pub. l. no. 116-136, § 4022, 134 stat. 281 (2020). 2021] the return on investment of pandemic rental assistance 311 payments due to covid-19 related hardship, including tenant hardship. federally backed properties have that option under the cares act.87 foreclosure protections are critical not only to the stability of mom-and-pop landlords, but also to ensure that tenants continue living in habitable, safe homes, as landlords may not have the motivation to ensure housing quality when homes are in receivership. 3. civil right to counsel similarly, studies have shown a civil right to counsel in eviction cases can deliver significant benefits for tenants, landlords, and society.88 legal aid attorneys have been proven to reduce disruptive displacement and achieve better outcomes for their clients compared to the alternative of lack of representation. in addition to providing representation, lawyers play a crucial role connecting tenants with other social services. at the same time, the success of legal services attorneys varies on the features of underlying state law, which sets the terms for counterclaims and defenses against evictions. while there are no definitive crossjurisdiction studies that use the same methods to test the underlying law, vast discrepancies in recorded outcomes can lead to that hypothesis. in boston, for example, tenants with access to full legal representation have a 66% chance of staying in their homes.89 in seattle, the figure is 20%.90 regardless of the quality of the underlying law, legal aid attorneys may be increasingly hamstrung by the accumulation of rental arrears, which deepens the root problem of an eviction case. in other words, legal assistance is a necessary but not sufficient solution to an eviction case. 4. civil debt conversion civil debt conversion is another rarely used but exceedingly powerful legal measure to prevent eviction. civil debt conversion is the transformation of rental debt into civil debt, which removes the landlord’s right to evict the tenant on the basis of that debt. the california legislature passed assembly bill 3088, which prevented landlords from evicting renters for pandemic related rental arrears during march to august 2020.91 87. id. 88. eviction right to counsel resource center, stout, https://www.stout.com/en/ services/ transformative-change-con su lt in g / ev ic t ion -r igh t-to-counsel-resources [https://perma.cc/nfy7-4jzq] (last visited apr. 8, 2021). 89. james greiner et al., the limits of unbundled legal assistance: a randomized study in a massachusetts district court and prospects for the future, 126 harv. l. rev. 901, 927 (2013). 90. see tara cookson et al., losing home: the human cost of eviction in seattle (2018), https://www.kcba.org/portals/0/pbs/pdf/losing%20home%202018.pdf [https://perma. cc/tbl8-k8nh] 91. 2020 cal. legis. serv. ch. 37 (a.b. 3088) (west). 312 indiana health law review [vol. 18:293 b. cash assistance to stabilize tenancies cash assistance is the single most important policy lever government can pull to reduce eviction risk. renters need money to pay their rents. landlords need money to pay their mortgages. and, only rental assistance payments can clear the ledger and make both parties whole. a number of policies designed to get cash into renters’ hands help flatten the covid-19 eviction curve, including direct cash transfers like universal basic income, unemployment insurance, grants to state and local providers, increases in housing vouchers, and emergency rental assistance can get money to at-risk renters. given the accumulation of rental arrears, flexible rental assistance funds may offer the greatest hope to clear large arrearages and stabilize future tenancies.92 the next part of this article explores the social and public benefits of rental assistance in depth. v. evaluating the costs and benefits of rental assistance effective policy solutions to the pandemic eviction crisis combine eviction moratoria with rental assistance.93 eviction moratoria keep renters in their homes during the pandemic or other public health crises, and they buy time for the administration of rental assistance. rental assistance stabilizes tenancies: it can cure rental arrears and ensure that tenants have the funds to pay rent while the economy recovers. it has the additional advantage of stabilizing landlords, making them whole or close to whole and enabling them to service their mortgage debt and pay property taxes. advocates across the country have been calling for both eviction moratoria and rental assistance, stating that together they stabilize families and landlords. there is significant literature about the benefits of eviction moratoria on keeping renters in their homes,94 including homelessness prevention and reduction in covid-19 spread.95 but to date, there has been only limited analysis of the relative benefits of a sustained federal rental assistance programs, especially on its impact for non-homeless individuals. elior cohen, a phd student at the university of california, los angeles, evaluated the effects of rental assistance among homeless individuals in los angeles county, finding that 80% of housing costs are offset by benefits within eighteen months for homeless single adults.96 92. see andrew aurand et al., nat’l low income hous. coal., nlihc research note: the need for emergency rental assistance during the covid-19 and economic crisis (2020), https://nlihc.org/sites/default/files/need-for-rental-assistance-during-the-covid19-and-economic-crisis.pdf [https://perma.cc/k5a7-u8cb]. 93. neumann et al., supra note 77. 94. see, e.g., the covid-19 eviction crisis, supra note 34. 95. id. 96. see, e.g., elior cohen, housing the homeless: the effect of housing assistance on recidivism to homelessness, economic, and social outcomes 3 (oct. 19, 2020) (working paper), https://nlihc.org/resource/housing-assistance-improves-health-and-well-being-reduces-returns2021] the return on investment of pandemic rental assistance 313 researchers at the national low income housing coalition and the university of arizona estimated the homelessness-related costs of eviction associated with covid-19, to be between $62 billion and $128 billion, depending on the number of households estimated to be at risk of eviction.97 the subsequent analysis aims to fill that gap by providing a directional estimate of the roi of federal rental assistance. in the following sections, this article lays the foundation for its assessment of the roi. it outlines how the covid-19 eviction defense project (“cedp”) roi model works; the six core building blocks of the model; the most sensitive assumptions in the model; the core scenarios used to estimate rental assistance; and concludes with an analysis of the roi. the roi analysis indicates that federal rental assistance has a roi of between 208% to 466%. this part concludes with the consideration of the costs avoided as a result of the stabilization of these tenancies. a. cedp roi model overview as detailed in part i, the cedp model estimates the roi of rental assistance by comparing the costs of pandemic-related displacement with quantifiable public and social costs avoided from that displacement. the model uses data from the end of december 2020. given the relative lack of financial assistance in the economy at this time, the model offers an opportunity to estimate the effects of rental assistance with fewer confounding variables. overall, the model produces a directional analysis of the costs of rental assistance compared to the costs avoided by preventing the social costs of eviction and homelessness. this methodology can help policymakers understand orders of magnitude: rois above 200% can be assumed to be significantly better than the alternative. small differences in roi calculations should not be heavily weighted in decisionmaking. the model considers the costs of up to two years of rental assistance (all rental debt for 2020 and future rent in 2021). rental payments cover only the months that a household would otherwise be at risk of eviction. when households stabilize economically, the model assumes the government stops paying rental assistance. because of the difficulty in estimating the rates of eviction for individuals awaiting rental assistance, the analysis assumes that all individuals who are projected to receive rental assistance get it instead of being displaced. however, as the eviction lab’s statistics prove, implementation and failures are significant and lead to thousands of irreversible and non-essential evictions. the roi calculation compares these projected costs with the net present value of three years of public and social costs avoided (2021-2023). the threeyear timeline was selected based on the best longitudinal data—through the homelessness [https://perma.cc/fu4c-md79]. 97. dan threet et al., costs of covid-19 evictions 4 (2020), https://nlihc.org/sites/ default/files/costs-of-covid19-evictions.pdf [https://perma.cc/py76-5bkl]. 314 indiana health law review [vol. 18:293 united states department of housing and urban development’s (“hud”) 12-city family options survey—on costs of shelter-based care extending three years.98 these costs avoided only relate to people who are projected to recover economically or “cure” housing insecurity by finding other affordable housing after receiving the benefit. the model does not count “costs avoided” for renters who are not projected to stabilize even though the net effect is a delay in the demand for social services, which itself may have significant net present value. the model includes estimates of public and social costs avoided from a rental assistance program. public costs include estimates of expected outlays of local, state, and federal funds associated with the outcomes of evictions. social costs include public costs as well as additional costs to individuals, landlords, neighborhoods, and society. cost avoided assumptions were only included where there was sufficient evidence to tie the magnitude of costs avoided to homelessness and eviction prevention. this was sufficient to estimate costs avoided in the following categories: housing, health care, employment, legal, foster care, landlord costs, foreclosure costs, and coronavirus costs. the costs avoided may be meaningfully larger than this article’s model indicates because estimates do not include large cost categories like education (which were especially hard to estimate in a pandemic context). figure 9 to execute this roi methodology, this model followed a six-step process, which is outlined in figure 9. 1. this model included source data for all renters from the american community survey, hud’s comprehensive housing affordability 98. see generally daniel gubits et al., u.s. dep’t. of hous. & urban dev., family options study: 3-year impacts of housing and services interventions for homeless families (2016), https://www.huduser.gov/portal/sites/default/files/pdf/family-options-studyfull-report.pdf [https://perma.cc/q8u5-jshf]. 2021] the return on investment of pandemic rental assistance 315 strategy (“chas”) data set, and the census bureau’s week 21 household pulse survey.99 2. it estimated the number of renters at risk of eviction accounting for an economic recovery. the number of people at risk of eviction and displacement is calculated over time based on the census bureau’s household pulse survey data on rental arrears and housing insecurity (renters who express slight or no confidence in their ability to pay rent next month). the economic recovery estimates are based upon the federal reserve’s projections for the decline in unemployment rates. any economic recovery that has already occurred is de facto incorporated into the model because weekly census bureau data accounts for the recovery. approximately 25% of renters at risk of eviction are assumed to stabilize economically between january 2021 and the end of 2021.100 3. the model simulated outcomes for renters at risk, estimating how many renters would face displacement under a rental assistance regime and how many would be displaced without intervention.101 the model further estimated renter outcomes, including shelter, rehousing, and doubling up for those who were estimated to have been displaced. for renters who do not stabilize due to economic recovery, the model also triangulates to a cure rate of 70% under a rental assistance regime, meaning that 30% of eligible renters are assumed not to stabilize even with access to rental assistance and would be at risk when the funds expire.102 these results were compared to the results of displacement in the absence of rental assistance. 4. the fourth building block estimates eligibility for rental assistance, uptake of rental assistance among the eligible population, the percentage of evictions avoided for people accessing rental assistance, and the price of rental assistance for this population based on the pandemic’s estimated impact on their income.103 it assumes rental assistance would cover all 2020 arrears and provide a stipend for all 2021 rent for renters who are estimated to remain at risk of eviction in 2021. 5. the model assessed the public and social costs associated with an eviction, drawing on dozens of academic studies about the outcomes of eviction and homelessness and refining estimates of the costs of 99. see infra part vii.a. 100. see infra part vii.b. 101. see infra part vii.a. 102. this means that for those who do not cure due to an economic recovery, 70% will find an alternate, permanent, and safe housing arrangement if given a year’s worth of rental assistance. see infra part vii.c. 103. see id. 316 indiana health law review [vol. 18:293 these outcomes based on state cost data.104 6. finally, it compared the two years of rental assistance costs to the estimated three years of benefits. b. scenario selection this article estimates the roi of three scenarios for federal rental assistance in increasing levels of coverage. each scenario is based on the framework of rental assistance provided in the consolidated appropriations act of 2021.105 • scenario 1 – federal emergency rental assistance (“era”): the first scenario provides a directional estimate of the roi for the emergency rental assistance authorized by the consolidated appropriations act of 2021.106 the appropriation authorized $25 billion in rental and utility assistance for households making less than 80% of the ami and aimed to prioritize households that make less than 50% of ami or had an unemployment event. households either qualified for unemployment benefits or experienced a reduction in income or significant financial hardship due to the coronavirus. the bill authorized payments for a maximum of twelve months with a three-month extension, including back and future rent, and allowed for 10% of funds to be spent on administration. • scenario 2 – expansive federal emergency rental assistance (“era+”): this scenario builds on the era scenario. it includes a more expansive qualification criterion, allowing anyone who makes ami or below (100% of ami) to qualify. it also includes individuals who are behind on rent but did not lose employment-related income during the pandemic. • scenario 3 – expansive federal emergency rental assistance + partial settlement (“era+ & partial settlement”): this scenario builds on the era+ scenario, with one additional criterion: landlords settle rental arrears at 80% of face value of the rental debt as a condition of receiving funds. this scenario is informed by washington state’s rental assistance model.107 it also includes an uptake rate of 100% to demonstrate the benefits of complete funding. c. findings: estimated returns on investment of rental assistance the model finds a three-year roi of pandemic emergency rental assistance of 208% to 466%. this conclusion indicates that paying people’s 104. see infra part vii.e. 105. h.r. 133, 116th cong. (2020). 106. id. 107. see generally wash. state dep’t of commerce, guidelines for the eviction rent assistance program (erap) (2020), https://deptofcommerce.app.box.com/s/kb5sds2gv4 yc9n931j1e7f1dikvlyub1/file/696873212517 [https://perma.cc/y9x7-rz46]. 2021] the return on investment of pandemic rental assistance 317 rents is almost always cheaper than the combined debts and outlays that might occur if the government does not foot the bill. more broadly, these roi estimates indicate that homeless prevention and housing security investments in the form of rental assistance are good financial investments. the outlays needed to provide rental assistance at take-up rates of 65% and 100% are in the tens of billions of dollars. as figure 10 illustrates, they range from $56 billion to $92 billion. governments have struggled to distribute financial assistance in general108 and rental assistance in particular to individuals who qualify.109 the model leverages the consolidated appropriations act’s 10% allowance for administration to attempt to quantify these costs. better program delivery, or payment at full face value, would increase the costs. as figure 10 illustrates, the outlays are significant, but the three-year returns on investment are enormous and increasing dependent on relative access. without such investments, local, state, and federal governments will have to foot enormous social services bills. public costs associated with homelessness and displacement from the pandemic project to devour local, state, and federal budgets. an investment of $56 billion in a rental assistance program—with similar parameters as the emergency rental assistance program in the consolidated appropriations act—would save an estimated $117 billion in quantifiable public costs alone. 108. ben zipperer & elise gould, unemployment filing failures: new survey confirms that millions of jobless were unable to file an unemployment insurance claim, econ. pol’y inst. (apr. 28, 2020), https://www.epi.org/blog/unemployment-filing-failures-new-survey-confirms-thatm il l ion s -of -job less -we r e -u n a b le t o f i l e -an -u n em ploymen t -in su ran ce-c la im / [https://perma.cc/sgw4-a7hy]. 109. conor dougherty, use it or lose it: tenant aid effort nears a federal cutoff, n.y. times (dec. 15, 2020), https://www.nytimes.com/2020/12/15/business/economy/rental-aid.html [https://perma.cc/a6ck-k3g3]; see also neumann et al., supra note 77. 318 indiana health law review [vol. 18:293 figure 10 scenario 1: emergency rental assistance roi 229% 392% support: 12.6 million people; 5.3 million households stabilize: 9.7 million people; 4.1 million households est. cost: $51 billion est. admin cost: $5.1 billion est. public cost savings: $117 billion est. social cost savings $200 billion the roi of the era program is estimated at between 208% and 355%. assuming sufficient funding for all who qualify, this intervention would support 12.6 million people in 5.3 million households. under the economic recovery and cure rate assumptions, the model estimates that this intervention could avoid disruptive displacement for nearly ten million people in over four million households. this scenario, which estimates the effects of the emergency rental assistance program in the consolidated appropriations act, shows that the most targeted rental assistance programs do not stabilize nearly as many renters as more generous programs. programs targeted at the lowest income renters can have higher rois due to lower rental outlays on average. 2021] the return on investment of pandemic rental assistance 319 scenario 2: enhanced emergency rental assistance (era+) roi 219-370% support: 17.7 million people in 7.5 million households stabilize: 13.7 million people in 5.8 million households est. cost: $69 billion est. admin cost: $6.9 billion est. public cost savings: $165 billion est. social cost savings $280 billion the roi of an expanded era targeted at renters making median income and below is between 219% and 370%. this intervention is estimated to support 17.8 million people in 7.5 million households. it could stabilize nearly fourteen million people in 5.8 million households this roi is relatively higher than the first scenario because federal rental assistance would be accessible to all renters who need it and make median income or below regardless of whether they lost significant income related to the pandemic. for the group that did not lose significant income during the pandemic, the costs of providing rental assistance are modeled at 20% of full rent per month behind, suggesting that rental assistance is an especially high roi investment for low-income individuals who are at the margins between being able to pay rent and not. it also assumes a higher total outlay of rental assistance driven by broader program applicability. scenario 3: 80% settlements of rental debts and enhanced emergency rental assistance roi 275-466% support: 27.2 million individuals in 11.5 million households stabilize: 21.1 million individuals in 8.9 million households est. cost: $89 billion est. admin cost: $8.9 billion est. public cost savings: $255 billion est. social cost savings $433 billion the model estimates that the roi of the government paying rental assistance for all renters experiencing housing insecurity below 100% ami is between 275% and 466%. this intervention is estimated to support 28.7 million people in 12.1 million households during the pandemic and stabilize 21.1 million people in 8.9 million households into 2022. this model offers the highest roi intervention evidencing the additional value that can accrue to governments from offering (or requiring) a settled rate at less than face value. settlements at less than face value can take rental assistance dollars further and/or pay for administration. 320 indiana health law review [vol. 18:293 d. detail: the drivers of roi the roi analysis illustrates that it will always be cheaper to pay a household’s rent than to pay for rehousing, health care, foreclosure, landlord debts, and all of the downstream impacts of displacement and homelessness. the primary drivers of the roi analysis are the costs associated with providing housing and health care to individuals who would otherwise be evicted absent intervention. as figure 11 illustrates, housing and health care are the largest drivers of costs. combined health care and housing costs account for more than 80% of the public costs of addressing homelessness and displacement in this model. among public costs, the largest drivers are the costs of shelter and health care with foreclosure and job loss costs driving a significant percentage. shelter and rehousing costs account for approximately 30% of the public costs avoided. combined hospitalization, physical health care, and mental health care services account for more than 50% of the costs avoided associated with rental assistance in this model. the social cost analysis also incorporates losses of wage income, landlord losses, eviction costs, and broader estimates of the effects of foreclosure on society. while the model is not able to capture all of the social costs of eviction, these categories demonstrate the breadth of the impact of eviction on society at large. the cost estimates are primarily driven by the known high costs of homelessness. for example, this model was unable to incorporate reliable estimates for the chronicand mental-health care costs of displacement for individuals who lose their housing, but who do not become homeless. figure 11 2021] the return on investment of pandemic rental assistance 321 e. breakeven analysis given the high proposed roi, the analysis also considers a break-even scenario. in other words: even if you believed only these programmatic assumptions, the financial benefits would equal the financial costs. in the case of preventing mass displacement, even a program that breaks even has serious merits. the model would reach an roi of 99.6% under a circumstance where it only considers the cost avoidance of not paying for shelter or rehousing and hospital care for individuals who become homeless or are otherwise displaced as a result of being evicted. these cost categories were chosen for the breakeven analysis because the research and the direct association with eviction is the strongest.110 as long as one considers that that there are additional costs of housing displacement beyond the estimated costs of shelter and hospital care and considers that peer-reviewed studies underlie these calculations, this analysis should give comfort that the government will at least break even on its rental assistance investments. f. state-by-state this model is built based on fifty-state data. as a result, the rois of rental assistance vary significantly by state depending on the percentage of renters who are at risk of eviction in those states and cost variation in certain states. state rois are particularly sensitive to average rents and the costs of shelter and health care in those states. rois range from ~150-400% in massachusetts and california, to 380-1128% in maine. table 1 includes the state-by-state rois using the public costs of the era scenario to set the lower bound and the social cost of the era+ negotiation scenario to set the higher bound. 110. see infra part vii.e (describing the data on housing costs and in-patient and emergency department related costs of homelessness). 322 indiana health law review [vol. 18:293 table 1 g. model sensitivity the model is most sensitive to the following five assumptions: 1. the percentage of renter households who recover economically. the federal reserve’s unemployment rate projections in 2020 and 2021 inform the modeled economic recovery rate during the rental assistance period.111 2. the percentage of renter households who “cure” after a year of rental assistance. the model employs elior cohen’s 2020 analysis on the effect of rental assistance on homeless individuals to estimate the percentage of renters who do not recover economically will cure with an extra year of rental assistance.112 cohen found that rental 111. fed. open mkt. comm., december 16, 2020: fomc projections materials, accessible version, board governors fed. res. sys. (dec. 16, 2020), https://www.federalreserve. gov/monetarypolicy/fomcprojtabl20201216.htm [https:/perma.cc/z8ww-23b6]. 112. see cohen, supra note 96. 2021] the return on investment of pandemic rental assistance 323 assistance was associated with a 20% recidivism rate to homelessness compared to 40% for those who do not receive rental assistance.113 the model uses the midpoint between these two points and assumes a 30% recidivism rate. to the author’s knowledge, there is no available data point for the long-term stabilization rate for nonhomeless renters who get a year’s worth of rental assistance. 3. the percentage of renter households who would require shelterbased care (and the associated assumption of a right to shelter). an estimated 21.8% of renters in arrears would require shelter or similar costs.114 4. the cost of rent by income tier. the model estimates the cost of rent by income tier using custom tabulations from the american community survey pms data that estimate the mean rents paid by individuals based on income.115 5. shelter costs by geography. shelter costs are the single most expensive cost in this model. they are based on the three-year costs of usual care in the family options survey model and scaled by state based on the average cost of rent in that state.116 h. implementation as the take-up rate illustrates, implementation is a tremendous challenge. while a thorough discussion of implementation is beyond the scope of this article, readers should consider a variety of design principles for ensuring high take-up rates.117 the most successful programs offer easy-to-complete application processes with low documentation burdens. they are marketed towards lowincome and traditionally underserved communities, including communities of color and mom-and-pop landlords who own a disproportionate amount of the naturally occurring affordable housing. they distribute funds quickly, and they do so at a negotiated rate rather than full payment—something that would further increase the roi of rental assistance. the model assumes a 10% cost of administration, matching the percentage in the consolidated appropriations act 113. id. 114. see infra part vii.c (discussing the estimated distribution of tenants to housing outcomes). 115. see infra part vii.b (discussing the methodology for calculating tenant rents). 116. see infra part vii.e (discussing the methodology for calculating shelter costs). 117. see generally kim johnson & rebecca yae, nat’l low income hous. coal., best practices for state and local emergency rental assistance programs (2021), https://nlihc.org/sites/default/files/best-practices-for-state-and-local-emergency-rentalassistance-programs.pdf [https://perma.cc/8dkw-5ewz]; neumann et al., supra note 77; principles for emergency rental assistance during the covid-19 crisis, nat’l hous. l. project (jan. 21, 2021), https://www.nhlp.org/wp-content/uploads/era-principles.pdf [https://perma.cc/ jv2n-m67g]. 324 indiana health law review [vol. 18:293 to account for the investment required to create efficient rental assistance delivery channels. vi. conclusion the patchwork of eviction moratoria and rental assistance has largely succeeded in keeping tenants in their homes, but debts are piling up and evictions are accelerating. with one in six renters in debt to their landlords, as of the end of 2020, the united states risks an unprecedented displacement and homelessness crisis. and, policymakers face a stark choice: pay now or pay much more later. from a human perspective, we understand that comprehensive policies to keep tenants in their homes are a no brainer. this article asked the financial question: can we afford such a comprehensive rental assistance program; would the benefits justify the costs? the answer is an emphatic yes. as this article illustrates, investing in a generous rental assistance program now will pay several times over. and therefore, nobody in america should face a loss of housing simply because they cannot pay rent for a few months, especially in an economic crisis. the benefits of a rental assistance program designed to achieve those ends flow to tenants, landlords, and governments alike. this roi analysis of pandemic rental assistance presents three core takeaways for policymakers. first, rental assistance is the rare win-win-win. tenants get to stay in their homes. landlords are made whole. and, governments save money. specifically, tenants do not just keep the roof over their heads, they keep their homes and everything those homes mean to them. the stability prevents the serious health and poverty consequences caused by eviction, displacement, and homelessness. landlords benefit as well. they avoid heavy financial losses; mom-and-pop landlords can pay the mortgage and avoid sale or foreclosure. governments maintain naturally occurring affordable housing and avoid having to make tremendous financial outlays in the form of housing, health, legal, education, and other social costs. for every dollar invested in a rental assistance program that covers tenants for up to two years, government could see $1.08 in savings (2.08 times the initial investment) and society could see upwards of $3.66 in benefits (4.66 times the initial investment). the roi model makes a compelling case that, faced with resource tradeoffs, governments should invest heavily in rental assistance. second, congress made a great investment in its emergency rental assistance allocation, and it should invest more and broaden the program. this article estimates that congress’ emergency rental assistance program has a quantified roi of 208-355%. while a good start, more resources and protections are needed to stabilize households. to cover the impacted population through the end of 2021, congress must allocate between $56 billion and $92 billion. it should also broaden the program. broadening the program to serve all who are behind on rent and make less than median income would increase the estimated roi to 275-466%. third, and more broadly, the roi analysis makes a compelling case that nobody in america should face a loss of housing simply because they cannot pay 2021] the return on investment of pandemic rental assistance 325 rent. reasonable people can disagree over what constitutes a “just cause” or “good cause” eviction. however, this analysis emphatically provides that a nonpayment eviction should never be deemed “essential.” while our eviction system has always been a moral failure—even more so in the midst of a deadly pandemic—the roi analysis suggests that it is also financial failure. we need a system focused on stabilizing renters in their homes rather than a system that sanctions displacement. the benefits would flow to tenants, landlords, and society alike. the benefits are financial. more importantly, the benefits are human. money and morality both argue for a reimagination of the social safety net for renters: with a rental assistance system, policymakers can eliminate nonpayment evictions and achieve a rare win for tenants, landlords, and government. vii. appendix: draft of methodology report for rental assistance roi model a. eviction risk model methodology: overview the rental assistance roi model simulates eviction risk, by state and by month based on individuals’ self-reported rental debts and their own expression of their ability to pay rent on time. estimates were made prior to the passage of federal rental assistance in the consolidated appropriations act and therefore contemplate eviction risk absent any federal intervention. at the end of 2020, 18% of renters were already in arrears, and 31% of renters had slight or no confidence in their ability to pay rent next month.118 when a family runs out of money and is unable to be able to pay rent on time, that family is “at risk of eviction.” of course, not all families who run out of money will go through the legal process of eviction or be involuntarily displaced. however, all families that run out of the ability to pay rent, face the risk of eviction and the likelihood of displacement. my eviction risk estimates include estimates of involuntary displacement. according to one matthew desmond and tracey schollenberger study of forced displacement in milwaukee after the great recession, for every formal eviction there are two informal evictions.119 this model is built off of three primary sources. first, its primary input is the week 21, public use file of the census bureau’s household pulse survey.120 second, it uses the 2019 american community survey to establish the number of renter households nationally, renter incomes, and the mean rent by ami tier.121 118. see week 21 household pulse survey: december 9 – december 21, supra note 8. 119. desmond & schollenberger, supra note 27. 120. see week 21 household pulse survey: december 9 – december 21, supra note 8. 121. household income by gross rent as a percentage of household income in the past 12 months, u.s. census bureau (2018), https://data.census.gov/cedsci/table?q=acs%20table% 20b25074,%201-year%20data%20for%202018&tid=acsdt1y2018.b25074&hidepreview=false [https://perma.cc/4dlc-gyaf]; public use microdata sample (pums), u.s. census bureau, https://www.census.gov/programs-surveys/acs/microdata.html [https://perma.cc/a9jh-93dn] (last 326 indiana health law review [vol. 18:293 third, it uses the census bureau’s chas data to establish the percentages of americans by ami tier and cost burden.122 the percentage of renter households at risk of eviction by month is based on the percentage of renters who indicate housing insecurity.123 the model begins with the percentage of renters who are housing insecure in the week 21 public use file for the household pulse survey, which includes data on housing insecurity and rental debts.124 it assumes that individuals who indicate that they are already in arrears and housing insecure were already at risk of eviction in 2020. individuals who indicate housing insecurity—but no arrears—are assumed to become at risk of eviction over time in 2021 as their resources run out. individuals who are in arrears but do not claim housing insecurity are assumed to “cure” and are therefore not at risk of eviction. the model includes estimates by income tier, finding greater housing insecurity among lower-income renters. it translates housing insecurity by income band into housing insecurity by ami tier. because the household pulse survey reports its responses at the person level for individuals older than eighteen, rather than the household level, the model scales responses to the household level with the assumption that adult (over-eighteen) responses are equivalent to household level responses.125 the model reports these eviction risk numbers in terms of people rather than households. it removes renters who do not report their income from both the numerator and the denominator. it calculates that the average renter family size is 2.37 compared to an average family size of 2.53 based on the american community survey.126 after estimating the point in time amount of insecurity and eviction risk, the model estimates when renters fall behind on rent and when they recover. the model uses three primary inputs to do this. first, the model assumes a rate of increase in the number of people who are behind on rent since march 2020—the updated feb. 23, 2021). 122. see generally consolidated planning/chas data, off. pol’y dev. & res., https://www. huduser.gov/portal/datasets/cp.html [https://perma.cc/d4t7-v9va] (last visited apr. 15, 2021). 123. housing insecurity, u.s. census bureau, https://www.census.gov/data-tools/demo/ hhp/#/?measures=hir [https://perma.cc/fse9-vqtz] (last visited feb. 26, 2021) (defining housing insecurity as people who answer that they have slight or no confidence that they will be able to pay rent on time next month or who are not current on rent). 124. see week 21 household pulse survey: december 9 – december 21, supra note 8. 125. alexander hermann & sharon cornelissen, housing perspectives – using the census bureau’s household pulse survey to assess the economic impacts of covid-19 on america’s households, joint ctr. for housing stud. harv. u. (july 2, 2020), https://www.jchs.harvard. edu/blog/using-the-census-bureaus-household-pulse-survey-to-assess-the-economic-impacts-ofcovid-19-on-americas-households [https://perma.cc/23bh-pugq] (describing the creation of household weights from person weights and the fact that only a single individual is surveyed per household). 126. acs demographic and housing estimates, u.s. census bureau (2018), https://data. census.gov/cedsci/table?q=united%20states&g=0100000us.04000.001&tid=acsdp1y2018. dp05&vintage=2018&hidepreview=true&moe=false&tp=false [https://perma.cc/7jq7-rffn]. 2021] the return on investment of pandemic rental assistance 327 majority of the increase occurring after the expiration of federal enhanced unemployment benefits in july and august 2020.127 the model employs the philadelphia federal reserve’s distribution of rental arrears—for those who lost jobs during the pandemic—as source data to estimate the percentage of renters who fell behind in each month and the percentage of arrears that accrued in that month.128 there is minimal data on the number of renters who fell behind by month and the amount of rental debt that has built up in the economy by month, this assumption was chosen as the best among few data points.129 second, the model establishes an estimated economic recovery as well as the rate of increase for eviction risk for housing insecure individuals who do not recover. the model estimates economic recovery over the next twelve months for approximately 25% of families at imminent risk of eviction, but families who do not experience an economic recovery ultimately exhaust financial resources to pay rent and therefore become housing insecure and at risk of eviction. federal reserve projections enable the estimate of a monthly “cure” rate of 2.1% per month in 2021, accounting for the number of people who can stabilize after returning to work.130 this economic recovery has the effect of “curing” housing insecurity in this model, assuming that these families who return to work could stabilize economically with payment plans. previous months of economic recovery are assumed to have been reflected in survey data: families that have recovered economically—who were previously housing insecure—are presumed to have at least moderate confidence in their ability to pay rent the next month. third, for prospective eviction risk, the model selects those who were not behind on rent on the household pulse survey but indicate slight or no confidence that they can pay next month’s rent on time, and it assumes that onesixth of them are at risk of eviction for the first time. this assumption is countered by the assumption of the economic cure rate. this assumption applies to both those who lost income and those who did not. by june 2021, all individuals who are housing insecure are estimated to have fallen behind without additional funds.131 127. alicia adamczyk, it’s been a month since the extra $600 per week in enhanced unemployment benefits expired. here’s where things stand now, cnbc (aug. 28, 2020), https://www.cnbc.com/2020/08/28/its-been-a-month-since-enhanced-unemployment-benefitsended.html [https://perma.cc/lea8-cmt0] (discussing the expiration of enhanced unemployment). 128. see generally davin reed & eileen divringi, fed. reserve bank of phila., household rental debt during covid-19 (2020), https://www.philadelphiafed.org/-/media/ frbp/assets/community-development/reports/household-rental-debt-during-covid-19.pdf [https://perma.cc/3f3v-9gus]. 129. see, e.g., parrott & zandi, supra note 55 (estimating aggregate rental arrears but not estimating arrears by month). 130. fed. open mkt. comm., supra note 111. 131. it is difficult to estimate how long people can continue to pay rent using earned income, borrowing, and scraping resources from other sources. this estimate assumes that families will have spent down all additional options outside of additional assistance within six months. see 328 indiana health law review [vol. 18:293 b. rental arrears 1. context a variety of actors have attempted to quantify the rental assistance needs in 2020 and 2021. stout produced a variety of measures,132 most recently estimating that americans will have accumulated between $13-24 billion in rental arrears.133 moody’s analytics (“moody’s”) recently updated their estimate of rental debt from $70 billion by the end of 2020134 to $57.3 billion.135 additionally, moody’s estimates total arrearages of $43 billion by june 2020, inclusive of the federal rental assistance ($68 billion without).136 both stout and moody’s based their estimates on the household pulse survey and considered rental arrears for “all delinquent renters” not just those impacted by the pandemic.137 the allocation of rental arrears by month in each methodology is unclear. this model estimates that covid-related rental arrears reached $22 billion in december 2020 and $27 billion in january 2021. these estimates fall at the high end of stout’s range and are approximately half of moody’ estimates. discrepancies are likely driven by a difference in the allocation of rental arrears by month and the fact that moody’s arrearages also include approximately 24% for utilities and late fees. accounting for utilities and late fees, cedp’s estimates for january 2021 would reach $33 billion. by june 2021, this model estimates a rental shortfall of $85 billion and a shortfall of $148 billion by december 2021. the june, $85 billion, shortfall figure is approximately in line with moody’s estimate ($67 billion accounting for the inclusion of federal stimulus). the primary differential is likely driven by differences in predicted economic recovery rates. the rental shortfall figure is an estimate of the amount of rental arrears that could build up in the economy at mathieu despard et al., do eitc recipients use tax refunds to get ahead? new evidence from refund to savings (2015), https://openscholarship.wustl.edu/cgi/viewcontent. cgi?article=1589&context=csd_research [https://perma.cc/sth6-avs5] (describing the fact that only 10% of eitc payments are still available after six months). 132. stout, analysis of current and expected rental shortfall and potential evictions in the u.s. 5 (2020), https://www.ncsha.org/wp-content/uploads/analysis-of-currentand-expected-rental-shortfall-and-potential-evictions-in-the-us_stout_final.pdf [https://perma.cc/7xft-2mpx]. 133. estimation of households experiencing rental shortfall and potentially facing eviction, supra note 52. 134. mark zandi, the week ahead-u.s. europe, asia-pacific, moody’s analytics (aug. 13, 2020), https://www.moodysanalytics.com/-/media/article/2021/weekly-market-outlook-marketvalue-of-us-common-stock-soars-to-record-high-percent-of-gdp.pdf [https://perma.cc/k8dlslzl]. 135. parrott & zandi, supra note 55, at 4. 136. id. 137. id. 2021] the return on investment of pandemic rental assistance 329 2021 rates, accounting for our estimated economic recovery. it is important to note, however, that this figure does not account for evictions—after which debt would stop accruing—or decreases in rent from 2020 numbers. 2. methodology a number of inputs drive these calculations of rental arrears: ami tier, mean rents by ami tier, pandemic employment impact category, and estimates of rental arrears by pandemic employment impact category. for each ami tier, the model estimates mean rents and multiplied them by the percentage of individuals in each pandemic employment impact category (job loss, wage loss but no job loss, and no job or wage loss), and the assumed percentage of rent owed by category the model establishes average rents by calculating the mean rent paid for each ami tier in the american community survey.138 estimates of rents by ami tier are based on the 2019 american community survey.139 first, ami boundaries were established at the 30%, 50%, 80%, 100%, and 150% levels. average rents by ami tier were established by calculating average incomes and average percentages of income paid to rent by ami tier. for renter-occupied homes where the renter is not paying rent, the “n/a” value was set to zero. the analysis considered both mean and median and used mean rents given the likelihood of skewed, non-normal distribution of rental prices, particularly at the bottom of the market. like stout, the model estimates arrearages, excluding those who live in subsidized housing.140 we estimate that approximately 15% of very low income households live in subsidized housing.141 arrearages for these individuals are assumed to be supported by rental recertification rather than rental assistance. next, the model is subdivided based on pandemic employment impact category—whether they lost their jobs, income, or did not lose jobs or income during the pandemic using the household pulse survey. this is an imperfect proxy based on the set up of the household pulse survey. the survey does not ask about job loss or wage loss directly, leading to the need to estimate. first, tenants are divided based on to their answer to a question about whether they have worked in the last seven days, using the variable “anywork”. for tenants 138. median hcir data by state (unpublished data) (on file with the author) (tabulated by national low income housing coalition). 139. see american community survey (acs), u.s. census bureau, https://www.census. gov/programs-surveys/acs [https://perma.cc/2qr5-79vq] (last visited apr. 8, 2021). 140. see estimation of households experiencing rental shortfall and potentially facing eviction, supra note 52. 141. federal rental assistance fact sheets, ctr. on budget & pol’y priorities (dec. 10, 2019), https://www.cbpp.org/research/housing/federal-rental-assistance-fact-sheets#us [https:// perma.cc/x5b4-cpnq]. this estimate includes the number of households by ami tier according to our estimates of ami tier and the number of households who live in federally subsidized housing according to the center on budget and policy priorities. 330 indiana health law review [vol. 18:293 who answer no they are further subdivided into assumptions of whether tenants lost their jobs or lost income based on the variable “rsnnowrk.” the model allocates the following reasons for “job loss”: (1) not wanting to be employed; (2) being sick with covid-19; (3) caring for someone with covid-19; (4) concerned about getting/spreading the virus; (5) being retired; (6) getting laid off due to pandemic, (7) place of employment closed temporarily; and (8) place of employment went out of business. responses about employers experiencing a reduction in business, including furlough, due to the pandemic are allocated to the “lost income but not wages” category. the model allocates “other” and “caring for a child” 50-50% between both categories. the result is: approximately 75% of renters who have lost income are coded as having lost jobs and 25% are coded as having lost income but not their job. for renters who lost their jobs, they are assumed to owe 100% of rent for each month in arrears. for renters who lost income but not full employment, they are assumed to owe 50% of rent for each month in arrears. for renters who did not lose their job, they are assumed to owe 20% of rent for each month in arrears. finally, the model estimates utility arrears using assumptions from the moody’s rental assistance analysis. it estimates that utility arrears are approximately 26% of rental arrears by month.142 c. eligibility, uptake, evictions avoided, and costs due to rental assistance 1. context: a small but growing body of evidence indicates that rental assistance has a high roi and reduces recidivism to homelessness among the population experiencing homelessness.143 this evidence, based on individuals who have already lost their homes, provides a good proxy for the effect of rental assistance in reducing the potential for homelessness among individuals who are housing insecure but not yet unhoused—the percentage of renter households who “cure” after a year of rental assistance. elior cohen’s 2020 analysis on the effect of rental assistance on homeless individuals in los angeles found that rental assistance was associated with a 20% recidivism rate to homelessness compared to 40% for those who do not receive rental assistance.144 in other words, 80% of tenants who received rental assistance in cohen’s study avoided future housing instability during the study period. the recently passed federal recovery act helps set parameters for eligibility assumptions. the appropriation authorized rental and utility assistance for households making less than 80% of the ami and aimed to prioritize households that make less than 50% of ami or had an unemployment event.145 households 142. parrott & zandi, supra note 55. 143. the new leaf project, found. for soc. change, https://forsocialchange.org/new-leafproject-overview [https://perma.cc/59wk-cy7l] (last visited feb. 28, 2021). 144. see cohen, supra note 96. 145. see h.r. rep. no. 116-68 (2020). 2021] the return on investment of pandemic rental assistance 331 either qualified for unemployment benefits or experienced a reduction in income or significant financial hardship due to the coronavirus. there is no good data on rental assistance uptake among those eligible due to the limited availability of funds and the difficulty of distributing funds during the pandemic. states and localities have also created or expanded rental assistance programs during the pandemic, leveraging federal and state dollars. according to the national low income housing coalition, states and localities have allocated $3.9 billion in rental assistance, with at least $2.9 billion coming from the cares act in 438 different rental assistance programs.146 these programs typically require renters to demonstrate covid-related economic hardship, proof of residency, income eligibility, among other criteria.147 as a variety of best practice guides reflecting on rental assistance distribution in 2020 have indicated, these documentation burdens can have the effect of slowing uptake and distribution of strained resources.148 for example, louisiana’s original application required a fifty-five-page application. despite the burden, the state closed the application three days after it opened, but disbursement challenges remained.149 it had disbursed only $115,000 of $5.6 million expected to go to new orleans residents. in massachusetts, the rental assistance program under the coronavirus relief fund has been described as “strained to the point of bursting” despite new infusions of state funds.150 the difficulty disbursing rental assistance suggests that it will be difficult to estimate take up rates among eligible renters, and it will be difficult to approach universal access for those who are eligible even if sufficient funds exist. 2. methodology rental assistance costs are determined on the basis of eligibility, uptake percentages, the percentages of evictions avoided due to economic recovery and “cures,” and the formula for calculating rental assistance. 146. see yae et al., supra note 42. 147. id. at 5. 148. see, e.g., neumann et al., supra note 77; johnson & yae, supra note 117; vincent reina et al., covid-19 emergency rental assistance: analysis of a national survey of programs (2021), https://nlihc.org/sites/default/files/hip_nlihc_furman_brief_final.pdf [https://perma.cc/nu7p-hf4n]. 149. michael isaac stein, suspended $24m state rental assistance program has only disbursed $115,000 in new orleans, lens (sept. 22, 2020), https://thelensnola.org/2020/09/22/ suspended-24m-state-rental-assistance-program-has-only-disbursed-115000-in-new-orleans/ [https://perma.cc/9xkw-ee5n]. 150. tim logan, delays and debt mount as state rent relief program strains to meet demand, bos. globe (oct. 24, 2020), https://www.bostonglobe.com/2020/10/24/business/delaysdebt-mount-state-rent-relief-program-strains-meet-demand/?p1=article_inline_text_link [https://perma.cc/x6cu-ub43]. 332 indiana health law review [vol. 18:293 a. eligibility the model considers two types of eligibility criteria: eligibility based on (1) covid-19 employment impact category and (2) pre-covid-19 income. the first eligibility scenario assumes that only those who have lost income and lost wages due to covid are eligible for this rental assistance.151 the second eligibility assumes that anyone can be eligible. both scenarios can either assume that renters of any pre-covid-19 income level who experienced a covid-19 economic hardship will be eligible for rental assistance or they can be limited based on ami tier.152 as noted in the scenario analysis, and in the above description of federal rental assistance, funds are prioritizing those who make less than 80% of ami. b. uptake percentages the model estimates that 65% of renters who are eligible will be able to access the rental assistance. this estimate is based on an economic policy institute study of unemployed workers accessing unemployment and pandemic unemployment assistance.153 the urban institute also used this 65% take up rate to estimate take up of rental assistance among those eligible.154 our model allows for estimates of different uptake percentages. given the documentation burden of rental assistance programs compared to unemployment filing, 65% is assumed to be the upper bound of uptake and disbursement. ben zipperer and elise gould further note that the real assistance take up rate may have been between 4552%.155 c. evictions avoided evictions avoided: evictions avoided are calculated based on eligibility, uptake, economic recovery, and cure rates. for people receiving rental assistance, the model assumes that rental assistance leads to an avoided eviction during the months that someone is receiving rental assistance. the model assumes that 25% of individuals would permanently avoid eviction based on the economic recovery in 2021. as outlined above, the model applies an economic recovery rate based on the federal reserve’s projections of improving unemployment rates in 2021.156 additionally, the model estimates that up to twenty-four months of rental 151. see supra part vii.b (describing how covid-19 employment impact categories are established). 152. see supra part vii.a (describing how the model incorporates ami tiers). 153. zipperer & gould, supra note 108. 154. strochak et al., supra note 28, at 5. 155. zipperer & gould, supra note 108. 156. see supra part vii.a (describing the economic recovery assumptions); see also press release, bd. of governors of the fed. reserve sys., chair’s fomc press conference projections (sept. 16, 2020), https://www.federalreserve.gov/monetarypolicy/files/fomcprojtabl20200916.pdf 2021] the return on investment of pandemic rental assistance 333 assistance leads 70% of renters to permanently avoid disruptive displacement.157 the model uses elior cohen’s 2020 analysis on the effect of rental assistance on homeless individuals to estimate the percentage of renters who do not recover economically but would cure with an extra year of rental assistance. cohen found that rental assistance was associated with a 20% recidivism rate to homelessness compared to 40% for those who do not receive rental assistance.158 this analysis uses the midpoint between these two points and assume a 30% recidivism rate. this proxy was used due to the lack of data on the long-term stabilization rates for non-homeless renters who get a year’s worth of rental assistance. d. costs of rental assistance costs of rental assistance: for each renter, this analysis estimates that rental assistance pays the tenant’s complete rent. this assumption is based on the consolidated appropriations act, which allows federal funds to cover the full amount of arrears for each applicant.159 the model calculates rent as a percentage of income as described above.160 d. potential outcomes for those who are housing insecure this model allocates all individuals who are housing insecure into estimated outcome groups without rental assistance. the allocations follow a decision tree that occurs at three levels: (1) formal v. informal evictions; (2) serial evictions for those in the formal eviction process; and (3) housing outcomes for those who are formally and informally evicted. 1. formal v. informal evictions a. context this is admittedly a rough assumption based on minimal data. the courts do not and cannot track informal evictions, and there are few studies that measure these outcomes. informal evictions are necessarily difficult to measure given that they occur outside of the formal legal system. as noted in the introduction, there are 3.2 million eviction filings in any given year.161 eviction filings are lagging numbers, as many tenants move at the [https://perma.cc/w8eh-p9yq]. 157. cohen, supra note 96. 158. see id. 159. h.r. 133, 116th cong. (2020). 160. see supra part vii.b (describing the calculation of mean rents by household type). 161. see map & data, eviction lab, https://evictionlab.org/map/#/2016?geography=states& bounds=-159.898,68.074,-72.438,79.561&type=er [https://perma.cc/xdc2-ljyg] (last visited feb. 28, 2021). 334 indiana health law review [vol. 18:293 first demand that they pay rent or vacate, or at the first mention of eviction. for example, 34% of people who received eviction notices in milwaukee, moved without going to court.162 the same study found that for every one formal eviction in milwaukee, there were two informal evictions.163 eviction threats create fear among renters who do not know their rights to legal process or have other reasons to fear engagement with the legal system. they also lead renters who understand that an eviction can function as a “scarlet e” to vacate their homes prior to a filing, so they can improve their ability to rerent in the future.164 b. methodology of those at risk of eviction, the model estimates that one third would go through the formal process of evictions and two thirds would face informal displacement. this assumption draws upon matthew desmond and tracey schollenberger’s 2015 study that uses 2009-2011 data on formal vs. informal evictions in milwaukee.165 the study finds a 2:1 ratio between informal and formal evictions.166 the model leverages this ratio to estimate that 33% of housing insecure individuals may experience a formal eviction filing with the courts when they exhaust their resources.167 the other 67% are estimated to face informal eviction after exhausting their resources. 2. for formal evictions: first-time displacement, serial evictions, and legal cures a. context: there is likely to be significant variability in cure rates and rates of serial evictions—rates that are inversely correlated. where serial eviction filings are high, tenants are more likely to cure, only to face eviction filings again in future months. in these states, eviction filings are often disproportionately used as a rent collection or tenant management tool.168 using a data set that includes more than eight million filing records from twenty-eight states, lilian leung, peter hepburn, and matthew desmond found significant “withinand between-state 162. @just_shelter, twitter (jan. 28, 2021, 5:51 pm), https://twitter.com/just_shelter/status/ 1354925182499102722 [https://perma.cc/8kpv-drv2]. 163. desmond & schollenberger, supra note 27, at 1761. 164. the scarlet e, supra note 68. 165. desmond & schollenberger, supra note 27, at 1761. 166. id. 167. id. 168. see lillian leung et al., serial eviction filing: civil courts, property management, and the threat of displacement, 99 soc. forces 1 (2020) (describing variability in serial eviction rates and cure rates). 2021] the return on investment of pandemic rental assistance 335 variation” in the rates of serial evictions by jurisdiction.169 they attributed serial eviction filing discrepancies to legal regimes, ownership structures, and property management strategies.170 serial evictions were most common in “mid-range rental markets,” suggesting that even in normal times renters in workforce and middle-income communities face eviction risk.171 b. methodology the formal eviction estimates are based on three important assumptions. first 19% of renters cure a non-payment eviction filing. this assumption comes from losing home: the human cost of eviction in seattle, finding that 75% of tenants vacated their unit after a filing.172 to reach this estimate, results where the outcome was unclear or the tenant died were omitted, leading to the estimate that 81% of tenants would vacate after a filing if no rental assistance was provided. the assumption was selected given the clarity of the data and the likelihood that significant rental arrears would ultimately be unrecoverable through an evictionas-rent-collection strategy. second, 30.4% of tenants experience a serial eviction filing—a second filing in our model.173 third, the model assumes a maximum of two eviction filings per year and per tenant household for simplicity. as rental arrears deepen during the pandemic economic crisis, property recovery may become a stronger goal of property owners relative to baseline. 3. for both: housing outcomes post eviction a. context a small number of studies have attempted to estimate the outcomes for folks who are evicted. robin hood, for example, estimates that 25% of evicted tenants in new york end up in shelter,174 a figure cited frequently in stout’s cost benefit analysis reports.175 a study of formal evictions in seattle found that most evicted residents became homeless with 37.5% unsheltered, 25% in a shelter, 25% doubled up, and 12.5% finding new homes; ultimately nearly half left the city.176 169. id. at 22. 170. id. at 2. 171. id. 172. cookson et al., supra note 90, at 55. 173. see leung et al., supra note 168. 174. neil steinkamp, the economic impact of an eviction right to counsel in baltimore city 38 (2020), https://cdn2.hubspot.net/hubfs/4408380/pdf/eviction-reportsarticles-cities-states/baltimore-rtc-report-final-5-8-2020.pdf [https://perma.cc/ug6a-xfjx] [hereinafter the economic impact] 175. see, e.g., id. 176. cookson et al., supra note 90, at 60. 336 indiana health law review [vol. 18:293 b. methodology the analysis assumes a right to shelter. the right to shelter is limited in the united states. only a few jurisdictions, including new york city, massachusetts, and washington, d.c., have a right to shelter (massachusetts and washington only have limited rights to shelter for families and in extreme weather conditions respectively). and, there are exceptions, like a loss of the right to shelter for residents of public housing in massachusetts who have been evicted.177 although a tens of thousands of individuals sleep unsheltered every night in the united states,178 and there is a likelihood of that number increasing without interventions, shelter costs are assumed for each household allocated to the “shelter” category. the social benefit of evictions avoided should not be depressed on the basis of cities’ failure to have a sufficient number of beds. moreover, like stout, estimates of shelter costs can be a helpful proxy for other rehousing costs necessary to achieve housing stability.179 potential housing outcomes post eviction consider tenants at risk of both formal and informal eviction, accounting for cure rates and serial eviction filing as outlined above. the cleveland eviction study forms the basis of estimates of “what happens next” to tenants after an eviction filing.180 the study found that 40.5% planned to find another rental, 16.7% planned to double up, 7.1% said they would live somewhere else, 9.5% said they would stay at a shelter, and 26.2% did not know where they would stay.181 the model uses these proportions with two modifications. first, those who say they would live somewhere else are assumed to double up, which has the effect of making cost avoided numbers more conservative. additionally, 50% of the individuals who “do not know” are assumed to “double up” and 50% are assumed to end up in shelter. 177. ruth bourquin, basic shelter rights (emergency assistance), masslegalhelp (jan. 2011), https://www.masslegalhelp.org/income-benefits/basic-shelter-rights [https://perma.cc/db43n9ba]. 178. u.s. dep’t. of hous. & urban dev., supra note 21. 179. neil steinkamp, cost-benefit analysis of providing a right to counsel to tenants in eviction proceedings 68 (2019), https://info.stout.com/hubfs/pdf/eviction-reportsarticles-cities-states/los%20angeles%20eviction%20rtc%20report_12-10-19.pdf [https://perma.cc/njk3-qnkg]; neil steinkamp, economic return on investment of providing counsel in philadelphia eviction cases for low-income tenants 44 (2018), h t t ps :/ / c d n 2 . h u bspot . n e t /h u bf s /4 4 0 8 3 8 0 /p d f/c os t -b en ef i t -im pac t -s tu d ies / philadelphia%20evictions%20report_11-13-18.pdf [https://perma.cc/nad9-u9sq] [hereinafter economic return]. 180. april hirsh urban et al., case w. res. univ., the cleveland eviction study: observations in eviction court and the stories of people facing eviction 30 (2019), https://case.edu/socialwork/povertycenter/sites/case.edu .povertycenter/files/201911/the%20cleveland%20eviction%20study-10242019-fully%20accessible%28r%29.pdf [https://perma.cc/2nx7-5nrj]. 181. id. 2021] the return on investment of pandemic rental assistance 337 combining the allocations and accounting for formal, informal eviction, cure rates, and serial eviction filings, the model projects that 43.3% of at-risk renters will find a new apartment, 31.4% will double up, 21.8% will end up in shelter, and 3.5% will permanently cure with their landlord and remain in their unit, without access to rental assistance or economic recovery. e. social costs avoided for those who access rental assistance (benefits) after allocating people at risk of eviction into their appropriate outcome groups, costs were allocated to each group. recall that tenants were divided based on whether they were at risk of formal vs. informal evictions, considering whether they vacate or do not vacate, and determining the percentage who end up finding a new home, doubled up with family, or in shelter. for each cost category, the model estimates the net present value of costs avoided and scales all financial figures to 2019 dollars. 1. time period like our cost of rental assistance analysis, the net present value of costs avoided (benefits) are considered over a three-year period because the best available data extends for that period of time. the three-year time period of benefits assumes that pandemic-related rental assistance is allocated in january 2021 and covers a year of future rent and up to a year of rental debts. the threeyear estimate is based on the family options study, a thirty-seven-month longitudinal study estimating the impact of shelter-based care, rapid rehousing, and a number of other housing interventions.182 while eviction moratoria and some rental assistance likely contributed to costs avoided in 2020, this analysis excludes those costs. 2. costs for families experiencing shelter based homelessness due to the data on the costs of providing services for people experiencing homelessness, cost estimates for the 21.8% of households estimated to experience shelter-based homelessness following displacement are much more mature compared to the remaining 78.2% of households assumed not to experience shelter-based homelessness. while it is likely that a meaningful percentage of those who do not immediately seek help from a shelter may ultimately require care from a shelter,183 this possibility was not measured given the difficulty in estimating moves between treatment buckets. 182. see gubits et al., supra note 98. 183. molly scott, doubled-up households: should they only count if they’re "homeless"?, urb. inst. (nov. 18, 2011), https://www.urban.org/urban-wire/doubled-households-should-theyonly-count-if-theyre-homeless [https://perma.cc/dkq7-stdh]. 338 indiana health law review [vol. 18:293 a. shelter based homelessness costs (i) context total household costs and lengths of stays vary widely by location. in philadelphia, the total annual cost per individual is $7,340 ($17,394 per household).184 in baltimore, it is $8,034 per household. in boston, the household cost is $26,618;185 and new york’s is $75,949 per year, with the average length of stay lasting 425 days.186 (ii) methodology the model estimates housing costs for individuals experiencing homelessness by location. it relies on the following inputs • the number and percentage of households at risk of eviction who would become homeless if evicted; and • the average annual cost of shelter by state (scaled by rent). costs associated with the 21.8% of at-risk households who experience shelter-based care are calculated based on the family options survey.187 over a thirty-seven-month period, usual emergency shelter care will cost $42,167, a rate of $13,676 per year (excluding inflation).188 rental costs were scaled by state based on average rent in that state. the family options survey was chosen because it provides the most comprehensive data set on the costs of shelter-based care across geographies and across time. the study evaluates four interventions for 2,282 families experiencing homelessness: subsidy-only care, project-based transitional housing, community-based rapid rehousing, and usual care “defined as emergency shelter and housing or services that families can access without an immediate referral to a program that would provide them a place to live.”189 the study evaluated families in a diverse set of locations: alameda county, ca; atlanta, ga; baltimore, md; boston, ma; new haven, ct; denver, co; honolulu, hi; kansas city, mo; louisville, ky; minneapolis, mn; phoenix, az; and salt lake city, ut.190 184. economic return, supra note 179, at 60. 185. dennis p. culhane & thomas byrne, ending family homelessness in massachusetts: a new approach for the emergency assistance program 4 (may 11, 2010) (unpublished manuscript), https://repository.upenn.edu/cgi/viewcontent.cgi?article=1152&context=spp_papers [https://perma.cc/ht2p-nrmw]. 186. giselle routhier, coal. for the homeless, state of the homeless 2018, at 10, 26 (2018), https://www.coalitionforthehomeless.org/wp-content/uploads/2018/03/cfhstateofthe homeless2018.pdf [https://perma.cc/9xuf-st7x]. 187. see gubits et al., supra note 98. 188. see id. 189. id. at xvi. 190. id. at iii. 2021] the return on investment of pandemic rental assistance 339 b. inpatient medical costs (i) context inpatient medical costs for individuals experiencing homelessness who get shelter-based care also vary by location. stout has estimated inpatient medical costs in philadelphia and baltimore among other cities, finding a wide range in costs. in philadelphia, the cost per visit was estimated at $9,000;191 in baltimore, it was nearly $38,000.192 in denver, based on our estimates, we find that inpatient care costs approximately $16,000 per visit. (ii) methodology the model estimates inpatient medical costs for individuals experiencing homelessness. it relies on several inputs. • the number and percentage of households at risk of eviction who would become homeless if evicted; • the percentage who would require inpatient services in a year and the average number of visits; • the percentage of visits attributable to the experience of homelessness; and • the net present value of the cost per visit by state. the methodology used in the cedp risk model parallels stout’s various access to counsel cost-benefit analysis reports to estimate the costs associated with inpatient medical care. the model assumes 23% of individuals in households experiencing homelessness will require an inpatient medical visit193 of an average of seven days.194 further, 80% of these visits are attributable to the experience of homelessness.195 daily costs of an inpatient visit come from the kaiser family foundation.196 multiplying these figures together yields an average cost per household per year of $7,500 per year. 191. economic return, supra note 179, at 46-47. 192. the economic impact, supra note 174, at 44. 193. see generally margot kushel et al., factors associated with the health care utilization of homeless persons, 285 jama 200 (2001). 194. see generally monica bharel et al., health care utilization patterns of homeless individuals in boston: preparing for medicaid expansion under the affordable care act, 103 am. j. pub. health s311 (2013). 195. kushel et al., supra note 193, at 200. 196. hospital adjusted expenses per inpatient day, kaiser fam. found. (2018), https:// www.kff.org/health-costs/state-indicator/expenses-per-inpatient-day/?currenttimeframe= 0&sortmodel=%7b%22colid%22:%22location%22,%22sort%22:%22asc%22%7d [https://perma.cc/2pzk-nnzm]. 340 indiana health law review [vol. 18:293 c. emergency room costs (applied to lowand high-cost scenarios) (i) context emergency room medical costs for individuals experiencing homelessness who get shelter-based care also vary by location. they are significant as unhoused individuals do not typically have access to other forms of care. in baltimore, stout estimated these costs at $7,602 per visit.197 in philadelphia, the costs were lower at $920 per visit.198 (ii) methodology the model estimates the cost of emergency room visits associated with individuals experiencing homelessness as a result of eviction. the model relies on several inputs: • the number and percentage of households at risk of eviction who would become homeless if evicted; • the percentage who would visit the emergency room in a year and the average number of visits; • the percentage of visits attributable to the experience of homelessness; and • the net present value of the cost per visit by state. the emergency room cost methodology is similar to the in-patient care methodology and largely tracks stout’s methodology.199 it draws on margot kushel et al.’s findings that 32% of homeless individuals visit emergency rooms each year,200 for an average of four days per year.201 there are 2.37 people in the average renter household nationwide. and an estimated 75% of these visits were as a result of the experience of homelessness.202 to establish costs, these figures are multiplied by fifty-state estimates of the costs of an emergency room visit.203 197. see generally the economic impact, supra note 174. 198. economic return, supra note 179, at 60. 199. see, e.g., id. 200. kushel et al., supra note 193. 201. bharel et al., supra note 194. 202. see generally margot kushel et al., emergency department use among the homeless and marginally housed: results from a community-based study, 92 am. j. pub. health 778 (2002). 203. alia paavola, the most, least expensive states for an er visit, becker’s hosp. rev. (dec. 7, 2020), https://www.beckershospitalreview.com/rankings-and-ratings/the-most-leastexpensive-states-for-an-er-visit.html [https://perma.cc/vj8d-fwrk]. 2021] the return on investment of pandemic rental assistance 341 d. foster care costs (applied in high-cost scenarios) (i) context homelessness is associated with greater risk of involvement with the childwelfare system compared to other low-income parents.204 for example, an analysis of longitudinal data in the national survey of child and adolescent well-being found that “inadequate housing” contributed to out-of-home placement in 16% of intact families under investigation.205 in other words, housing is a significant contributor to foster care placement even when a family unit is still together. (ii) methodology the model estimates the percentage of children who would require foster care based on living in households who would be at risk of homelessness that would require shelter-based services if they were evicted. • the number and percentage of households at risk of eviction who would become homeless if evicted and have children, including the number of children; • the percentage who would be put in foster care; and • the net present value of the cost per year. among the 21.8% of at-risk households who may be at risk of shelter-based care, 46% of housing insecure households have children.206 among renter households with children, the average number of children is 2.1.207 nearly 4% of children from evicted families are placed in foster care.208 this may be an underestimate of costs, as the analysis only considers costs for children experiencing homelessness and does not consider other forms of inadequate housing. haksoon ahn et al. provide estimates of minimum adequate foster care costs for children in the united states: they include $859 per month for children between the ages of four and thirteen ($749 for children zero through four and 204. jennifer culhane et al., prevalence of child welfare services involvement among homeless and low-income mothers: a five-year birth cohort study, 30 j. soc. & soc. welfare 79, 79 (2003). 205. patrick j. fowler et al., inadequate housing among families under investigation for child abuse and neglect: prevalence from a national probability sample, 52 am. j. community psychol. 106, 106 (2013). 206. week 20 household pulse survey: november 25 – december 7, u.s. census bureau (dec. 16, 2020), https://www.census.gov/data/tables/2020/demo/hhp/hhp20.html [https://perma.cc/ 99xj-sdtz]. 207. acs demographic and housing estimates, u.s. census bureau (2018), https://data. census.gov/cedsci/table?g=0100000us&tid=acsdp1y2019.dp05 [https://perma.cc/ez7d-3vl3]. 208. lisa berg & lars brannstrom. evicted children and subsequent placement in out-ofhome care: a cohort study, 13 plos one art. e0195295, at 6 (2018). 342 indiana health law review [vol. 18:293 $941 for children fourteen to eighteen).209 the multiplication translates into $10,188 per year per child before inflation. e. mental health care costs (i) context evictions are known to cause increases in mental health issues.210 a 2017 meta-analysis of studies on eviction and health concluded that “general consensus that individuals under threat of eviction present negative health outcomes, both mental (e.g. depression, anxiety, psychological distress, and suicides) and physical (poor self-reported health, high blood pressure and child maltreatment),” finding negative mental health outcomes in eleven cohort studies, eight individual cross-sectional studies, and three ecological studies.211 (ii) methodology the model estimates the financial impact of homelessness-related mental health issues. it uses the following inputs. • the number and percentage of households at risk of eviction who would become homeless if evicted; • the percentage of chronic health problems associated with homelessness; • the number of quality adjusted life years from avoiding chronic mental health problems; and • the value of a quality adjusted life year. the model draws upon robin hood’s methodology to calculate the social cost of eviction-related mental health issues.212 robin hood estimates a twentynine-percentage point differential in the likelihood of experiencing depression among homeless children compared to low-income children, based on research conducted by the national center for family homelessness.213 they, stout, and this model use the robin hood rate for both homeless children and adults.214 the 209. see haksoon ahn et al., estimating minimum adequate foster care costs for children in the united states, 84 child. & youth serv. rev. 55 (2018). 210. see, e.g., rilwan babajide et al., the effects of eviction on people in middlesex county, partnership for strong communities (june 28, 2016), https://www.pschousing.org/news/ effects-eviction-people-middlesex-county#:~:text=additionally%2c%20most%20individuals% 20lose%20feelings,it's%20a%20feeling%20of%20helplessness [https://perma.cc/3b7e-ar86]. 211. hugo vasquez-vera et al., the threat of home eviction and its effects on health through the equity lens: a systematic review, 175 soc. sci. & med. 199, 202 (2017). 212. see generally robin hood, metrics equations (2014), https://robinhoodorgproduction.s3.amazonaws.com/uploads/2017/04/metrics-equations-for-website_sept-2014.pdf [https://perma.cc/dv3y-qlam]. 213. id. at 82. 214. id.; economic return, supra note 179. 2021] the return on investment of pandemic rental assistance 343 estimated value of avoiding mental illness is 0.33 of a quality-adjusted life year (“qaly”), and a qaly has an estimated value of $50,000. applying this calculation to each household member, the total annual mental health cost per household, adjusted for inflation, is $12,521. f. chronic health care costs (i) context evictions and homelessness have also been associated with chronic physical health issues.215 homelessness and eviction are associated with chronic illness based on the same national center for family homelessness study cited by robin hood.216 a 2016 metanalysis found sixteen studies linking eviction and the threat of household instability to negative health outcomes.217 (ii) methodology the model estimates the cost of chronic health care for individuals who are evicted and as a result experience homelessness. the model employs several inputs: • the number and percentage of households at risk of eviction who would become homeless if evicted; • the percentage of chronic health problems associated with homelessness; • the number of quality adjusted life years from avoiding chronic health problems; and • the cost of a quality adjusted life year. these estimates draw upon robin hood’s methodology to estimate the social cost of eviction-related chronic illness. robin hood estimates a 0.1 qaly value for reduction in chronic illness on the basis of a qaly difference between those with well controlled and non-well-controlled asthma.218 they indicate that this is likely “a conservative guess” given the potential for more than one chronic illness.219 they extrapolate this rate to apply to the whole population.220 the estimated 2014 price of a qaly is $50,000. this model estimates a sevenpercentage point decrease in chronic illness based on the same national center for family homelessness study.221 combined, the total annual costs of chronic physical health care associated with an eviction, inflation adjusted, are estimated 215. vasquez-vera et al., supra note 211, at 202. 216. id. 217. id. 218. robin hood, supra note 212, at 81-82. 219. id. 220. id. 221. id. 344 indiana health law review [vol. 18:293 to be $915.84 per household. g. job loss (i) context: typically, people understand job loss to be a cause of evictions. in 2016, matthew desmond and carl gershenson released an analysis that found that job loss is not just a cause of evictions but also a consequence of evictions.222 (ii) methodology the model estimates the social and public costs of job loss related to evictions for individuals who did not lose their jobs during covid. the model is based on five inputs: • population of individuals by state who are at risk of eviction and would face non-shelter-based displacement; • the percentage of individuals who still employed among those at risk of eviction; • the percentage decrease in employment associated with an eviction; • the number of months unemployed; and • income replacement by ami tier. the population of individuals by state who are at risk of eviction and the percentage of individuals still employed are estimated using the cedp eviction risk model.223 in other words, this estimate only considers people who are at risk of eviction and whose eviction could trigger job loss. the percentage decrease in employment associated with an eviction is estimated to be 17%. this figure is the midpoint of the estimated effect of eviction on employment identified in matthew desmond and carl gershenson’s 2016 study topic.224 this is likely a conservative number on two dimensions: it only uses the midpoint desmond-gershenson range, and the analysis does not apply to those who lost wages but not their jobs. unemployment following job loss is assumed to be six months based on january 2021 data from the federal reserve bank of st. louis.225 to calculate social costs, the model multiplies the number of unemployed renters who faced eviction and lost their job as a result by the weighted average monthly income for each ami tier. to calculate public costs, it considers the 222. desmond & gershenson, supra note 63, at 67. 223. see desmond & gershenson, supra note 63, at 61-64 (discussing the methodology for calculating the percentage of individuals at risk of eviction and for a description of pandemic employment impact categories). 224. id. at 60. 225. average weeks unemployed, fed. res. econ. data, https://fred.stlouisfed.org/series/ uempmean [https://perma.cc/clb4-ttnw] (last visited feb. 27, 2021) (detailing twenty-six weeks as the average number of weeks unemployed in january 2021). 2021] the return on investment of pandemic rental assistance 345 unemployment outlays by state and the lost income tax to the state. it estimates that the public cost of unemployment is approximately 70% of prior wages. state unemployment replaces approximately 50% of wages,226 and the state and federal government lose approximately 19% of wages in the form of tax income.227 h. criminal costs (i) context the experience of homelessness has also been associated with increased involvement with the criminal system.228 it is critical not to draw a causal association between homelessness and criminal involvement. indeed, the experience of homelessness is associated with police interaction, including instances where police officers enforce statutes and ordinances designed to prevent individuals experiencing homelessness from resting in a given location.229 nevertheless, and often as a result of this policing, criminal system costs are disproportionately higher for populations experiencing homelessness than other low-income populations. cohen’s study, for example, found that formerly unhoused individuals receiving housing assistance were associated with a 7.9 percentage point lower probability of being charged with a crime and a thirteen day decrease in the average number of jail days compared to unhoused individuals who did not receive housing assistance.230 it also found a nonstatistically significant association with reduced probation.231 226. policy basics: unemployment insurance, ctr. on budget & pol’y priorities, h t tps:/ /www.cbpp.org/research/economy/policy-basics-unemployment-insurance [https://perma.cc/nn3j-f68e] (last updated jan. 4, 2021). 227. adam mccann, 2020’s tax burden by state, wallethub (june 24, 2020), https://wallethub.com/edu/states-with-highest-lowest-tax-burden/20494 [https://perma.cc/w3w6z7fl]. 228. see, e.g., brooke spellman et al., u.s. dep’t of hous. & urban dev., costs associated with first-time homelessness for families and individuals 29 (2010), https://www.huduser.gov/portal//publications/pdf/costs_homeless.pdf [https://perma.cc/vj9zqqt7]; dennis culhane et al., public service reductions associated with placement of homeless persons with severe mental illness in supportive housing, 13 hous. pol’y debates 107, 137 (2002). 229. see generally tony robinson & allison sickels, no right to rest: criminalizing homelessness in colorado (2015), https://denverhomelessoutloud.files.wordpress.com/2016/03/ no-right-2-rest.pdf [https://perma.cc/y27u-f3yb]. 230. cohen, supra note 96, at 106. 231. id. 346 indiana health law review [vol. 18:293 (ii) methodology the model estimates criminal system costs associated with the policing of homelessness. the model relies on the following inputs: • the percentage of adults at risk of eviction who would require shelter-based care; • the percentage estimated to become involved with the criminal system; and • the typical cost of criminal system involvement for adults. the model begins by estimating that 36% of adults of households who require shelter services as a result of a displacement would become involved with the criminal system.232 the average number of adults per renter household is 1.54. this estimate leverages elior cohen’s experimental data on rental assistance and criminal system costs in los angeles to estimate that the eighteen-month cost savings of criminal system involvement that could be avoided through effective rental assistance is $1,724 and therefore the twelve-month costs avoided are $1,149.233 i. landlord eviction and displacement costs (i) context while the majority of this piece has focused on the costs of evictions to tenants and government, it is important to highlight the cost of non-payment of rent to landlords. when landlords move to evict or displace tenants, they often do so by accepting complete losses on the property and the costs of turning over the property. the national apartment association estimates that the typical collections rate may be less than 10% for affordable housing.234 (ii) methodology the model offers conservative cost estimates of the cost to landlords of evicting tenants. these costs are only included in estimates of the “social cost” of eviction. the model includes the following inputs. • estimated uncollected rental arrears; • costs of changing the locks as a low-range proxy for property damage; • turnover costs estimated as one month of rent; and • court costs and legal fees borne by the landlord for the approximately one third of tenants who this model estimates would be face eviction through the legal system. the biggest driver of these cost estimates is “uncollected rental arrears.” the 232. robinson & sickels, supra note 229. 233. cohen, supra note 96, at 38. 234. multifamily debt collections: best practices for owners and managers, supra note 11. 2021] the return on investment of pandemic rental assistance 347 analysis pulls upon the rental shortfall analysis that estimates the total potential rental arrears in the economy.235 based on a national apartment association report, the model assumes that landlords will collect only 10% of rental arrears; 90% of rental debts prior to a displacement are counted as losses.236 this number may be conservative absent federal rental assistance given the massive arrearages during the pandemic. the model assumes for simplicity purposes that all at risk renters would be displaced by the end of 2021 assuming a constant rate of displacement. it constructs the counterfactual by assuming that all renters at risk of eviction would be displaced in 2021 absent rental assistance. it assumes that displacement would occur at an even rate, with 8% of potential displacements occurring over each month. this assumption simplifies because it is impossible to estimate how displacement would proceed without eviction moratoria in place given the paucity of data on displacements during the pandemic and the unprecedented number of evictions that could occur. this assumption limits the landlord costs only to rental debt and not rental shortfall. property costs are conservatively estimated at the cost of changing the locks—though, landlords are likely to face higher costs due to wear and tear, property damage, and renovation costs. the model does not include moving costs. vacancy costs are set at one month’s rent. apartment vacancies have been rising in the pandemic,237 and rents have declined overall.238 however, a closer look at the data shows sustained increases in rental prices for “low” and “moderate” quality homes.239 homes at the bottom-end of the rental market are continuing to see rental price increases,240 demonstrating high demand and a lack of supply of affordable housing.241 estimates of legal fees and court costs vary meaningfully by jurisdiction. for the purposes of this model, they are derived from a triangulation between the 2018 transunion analysis of the costs of eviction242 and the american tenant 235. see supra part vii.b (describing methodology for estimating rental arrears). 236. multifamily debt collections: best practices for owners and managers, supra note 11. 237. joint ctr. for hous. studies of harvard univ., the state of the nation’s housing 2020, at 32 (2020), https://www.jchs.harvard.edu/sites/default/files/reports/files/harvard_ jchs_the_state_of_the_nations_housing_2020_report_revised_120720.pdf [https://perma.cc/ ha75-fsjp]. 238. id. 239. id. 240. id. 241. see nat’l low income hous. coal., the gap: a shortage of affordable homes 4 (2020), https://reports.nlihc.org/sites/default/files/gap/gap-report_2020.pdf [https://perma.cc/ 47j2-bcvy] (discussing the fact that there are only 36 units available for every 100 tenants in need of affordable housing). 242. andrea collatz, the true cost of an eviction, transunion (nov. 2, 2018), https://www. mysmartmove.com/smartmove/blog/true-cost-eviction.page [https://perma.cc/7m29-bgfy]. 348 indiana health law review [vol. 18:293 screen’s analysis.243 2. non-shelter-based displacement costs there is considerably less data available about the social costs and relative effects of increased housing insecurity not associated with homelessness, so our analysis of non-shelter-based homeless costs is much more limited. thus, the model considers only three sets of costs associated with displaced individuals who do not require shelter-based homelessness: (1) the cost of finding a new home for those allocated to that outcome; (2) increased health care costs from having non-affordable housing; and (3) job losses as a result of the displacement for those who remain employed (and did not lose wages during the pandemic). of course, eviction and the threat of eviction have been linked to other negative consequences, including chronic physical and mental health care.244 while this analysis is unable to estimate those costs, it bears mention that those costs exist—and their existence likely increases the roi of stabilizing households. a. costs of finding a new home (i) context state laws and conventions for the cost of rehousing vary widely.245 in practice, tenants are often required to pay at least one month’s rent in addition to another month’s rent for a security deposit. other geographies require at least two months’ rent and/or the payment of first month’s rent, last month’s rent, and deposit. (ii) methodology the model assumes that each renter household, on average, that must find a new home will have to pay first month’s rent and a security deposit equivalent to one month’s rent costs. while some localities and rental properties require three months’ (first, last, and security deposit), this model employs the conservative assumption of only two months’ worth of funds to move into a new apartment. while most assumptions in this model operate at the person level, this operates at the household level. the estimates for the costs of finding a new home are based on three assumptions. 243. how much will it cost to evict my tenants?, am. tenant screen, https:// americantenantscreen.com/how-much-will-it-cost-to-evict-my-tenants/ [https://perma.cc/a8272pt5] (last visited feb. 28, 2021). 244. vasquez-vera et al., supra note 211, at 202. 245. security deposit limits, state-by-state, nolo, https://www.nolo.com/legalencyclopedia/chart-security-deposit-limits-state-29020.html [https://perma.cc/h2xu-vhuc] (last updated dec. 9, 2021). 2021] the return on investment of pandemic rental assistance 349 • the number of households at risk of eviction estimated to avoid shelter-based homelessness; • the average cost of rent by state; and • the number of households at risk are based on the cedp eviction risk model.246 the average cost of rent by state is based on the american community survey’s rental data by state.247 b. health care costs (i) context lack of affordable housing has been linked with poor health and limited ability to seek health care.248 substandard housing, including residential crowding that might be caused by doubling up, has been linked to health issues.249 low income families struggling to pay rent, for example, are less likely to regularly access the same medical care.250 (ii) methodology the model estimates health care costs for those who experience non-shelterbased displacement. it relies on two primary inputs: • the number of individuals in households at risk of eviction who would not experience shelter-based displacement; and • the cost of health care for those who do not live in affordable housing. these estimates are based on a study of the effects of affordable housing on health care usage in oregon.251 in total, various affordable housing interventions decreased medicaid expenditures by 12%, while the usage of outpatient care increased and emergency department care decreased.252 while the study investigated a number of types of affordable housing interventions, including 246. see supra part vii.a. 247. see supra part vii.b. 248. lauren taylor, housing and health: an overview of the literature, health affairs (june 7, 2018), https://www.healthaffairs.org/do/10.1377/hpb20180313.396577/full/ [https://perma. cc/sv4h-7a69]. 249. see claudia d. solari & robert d. mare, housing crowding effects on children’s wellbeing, 41 soc. sci. res. 464 (2012). 250. paula braveman et al., housing and health, robert wood johnson found. (may 2011), https://www.rwjf.org/content/dam/farm/reports/issue_briefs/2011/rwjf70451 [https://perma. cc/t78p-bwvd]. 251. see generally bill wright et al., health in housing: exploring the intersection between housing and healthcare (2016), https://www.enterprisecommunity.org/download? fid=5703&nid=4247 [https://perma.cc/sxv5-lvna]. 252. id. 350 indiana health law review [vol. 18:293 permanent supportive housing and housing for seniors with disabilities, this analysis only considers family housing—which is most analogous to the precovid-19 housing context of the majority of the demographic. the study found a comparably smaller effect on expenditures. when selecting the family housing option, the analysis finds a $22 monthly decrease in the amount of medicaid spending per person.253 the study found a strong association, but it is not statistically significant at the 5% or 10% level (p value of 0.12%); nevertheless, this study offers a reasonable estimate of the comparative health benefits of affordable housing compared to necessarily less affordable housing absent rental assistance. c. job loss costs both the context and the methodology are the same for cost estimates of job loss costs for individuals who are displaced but do not experience shelter-based homelessness, as they were under the shelter-based homelessness category. d. landlord eviction and displacement costs both the context and the methodology are the same for landlord eviction and displacement cost estimates for individuals who are displaced but do not experience shelter-based homelessness, as they were under the shelter-based homelessness category. 3. broader population costs the model also considers two cost categories that impact broader society: foreclosure and covid-19 hospitalizations. a. foreclosure costs (i) context evictions do not occur in a vacuum. when tenants cannot pay their rent, landlords—particularly mom-and-pop landlords—cannot pay their mortgage. failure to pay mortgages leads to foreclosure and the accompanying financial and social consequences for the community. while likely understated, this model incorporates an analysis of foreclosure-related risk to demonstrate that failure to provide rental assistance leads to cascading consequences in the housing market in addition to the human suffering for evictees, as well as massive financial outlays for state and local governments. 253. id. 2021] the return on investment of pandemic rental assistance 351 (ii) methodology the model also includes an analysis of potential foreclosure costs for families living in oneto four-unit rental properties, with mortgages that are owned by individual investors. this approach broadly follows the methodology charted by the harvard joint center for housing studies.254 the center’s analysis found significant risk in small buildings and a higher concentration of renters at risk of covid-19 related job loss, as these buildings offer a high percentage of naturally occurring affordable housing.255 this analysis is likely to be a conservative presentation of the potential foreclosure-related costs because a rent-related foreclosure crisis would likely affect properties larger than oneto four-units as well. the analysis finds 5% of landlords at risk of an eviction-related foreclosure. the public and social costs of eviction-related foreclosure by state are based on two inputs: • the number of properties owned by at-risk mom-and-pop landlords measured by (a) the percentage of individual investors who own one to four properties (b) that rent to non-paying renters and (c) have a mortgage (d) where the debt service coverage ratio is less than 80%, assuming (e) half are at risk;256 and • the public and social cost of foreclosure measured by the net present value of the cost of a foreclosure, estimated from great recession studies of the foreclosure crisis. to calculate foreclosure costs, the model considers the addressable population257 who live in one to four family units owned by individual investors, selecting the population with a mortgage and a debt service coverage ratio under 80%. all data comes from the rental housing finance survey.258 these assumptions culminate in a calculation that 5% of displaced renters live in a unit that could be at risk of foreclosure. while likely an understatement, this analysis is illustrative of the systemic risk posed by a rental eviction crisis. the costs of foreclosure were well-studied during and after the last housing crisis. the senate’s joint economic committee estimated the social cost of foreclosure to be $77,935, based on costs to financial institutions, cities and localities, and the homeowners.259 in 2019 dollars, that total cost is $96,095. total social costs also included costs to homeowners, renters, state and local governments, as well as neighborhood cost. total public costs were estimated at 254. airgood-obrycki & hermann, supra note 50. 255. id. 256. rental housing finance survey (rhfs), u.s. census bureau, https://www.census. gov/programs-surveys/rhfs.html [https://perma.cc/3un7-c6lv] (last visited feb. 28, 2021). 257. week 20 household pulse survey: november 25 – december 7, supra note 206. 258. rental housing finance survey, supra note 256. 259. charles e. schumer, chairman, joint econ. comm., sheltering neighborhoods from the subprime foreclosure storm 16 (2007), https://www.jec.senate.gov/archive/ documents/reports/subprime11apr2007revised.pdf [https://perma.cc/qvk3-t97s]. 352 indiana health law review [vol. 18:293 $23,537 per home on the basis of the costs to state and local government of foreclosure and excluding costs to financial institutions and the homeowners themselves. b. covid-19 costs (i) context a growing body of research has linked evictions to the spread of covid-19 and therefore to covid-19 related fatalities. in early 2021, researchers at the national bureau of economic research found, for example, that comprehensive bans on evictions could have reduced infections by 14.2% and deaths by 40.7% during the crisis.260 researchers at the university of pennsylvania261 and teams collaborating with emily benfer,262 have also linked eviction to covid-19 infections and deaths. (ii) methodology: the model dynamically estimates the percentage increase in covid-19 hospitalizations related to eviction and the costs of those hospitalizations. the public and social costs are based on four inputs: • the urban population of each of the fifty states; • the absolute value of the decrease in infection rate due to intervention; • the hospitalization rate as a percentage of the infection rate; and • public and social costs per hospitalization. the social and public costs related to covid-19 infection can be calculated by multiplying the urban population by intervention effect on infections by the hospitalization rate by the cost per hospitalization. to calculate the decrease in infection rate caused by the intervention, it begins by calculating the decrease in eviction rate. the model starts with the urban population263 because the source study that estimates the effect of a change in eviction rate on covid-19 transmission only simulated urban spread.264 it assumes a baseline infection rate of 23%.265 this baseline infection rate matches 260. jowers et al., supra note 71. 261. justin sheen et al., the effect of eviction moratoria on the transmission of sars-cov2, at 1 (jan. 19, 2021) (unpublished manuscript) (on file with the indiana health law review). 262. benfer et al., supra note 36, at 11. 263. urban area facts, u.s. census bureau, https://www.census.gov/programs-surveys/ geography/guidance/geo-areas/urban-rural/ua-facts.html [https://perma.cc/8a9m-ud7j] (last visited feb. 22, 2021). 264. sheen et al., supra note 261, at 4. 265. youyang gu, path to herd immunity normality: 2020 outlook of covid-19 in the us, covid-19 projections, https://covid19-projections.com/path-to-herd-immunity/ [https://perma. cc/2fqb-k7hy] (last updated feb. 21, 2021) (using estimates from january 1, 2021). 2021] the return on investment of pandemic rental assistance 353 the low end of justin sheen et al.’s strong lockdown and second wave scenario.266 leveraging the university of pennsylvania study,267 and annualized eviction risk projections,268 and considering the baseline monthly displacement rate leads to a baseline of approximately 2% without intervention. this baseline under the current infection rate would suggest a 10.8 percentage point increase in infections over a six-month period associated with displacement absent intervention.269 it dynamically estimates the delta in eviction rate based on the difference between the baseline rate and the rate after intervention. based on the delta in eviction rate, it estimates the decrease in infection rate. the model again leverages the simulated relationship between eviction rate and infection rate270 to establish the effect of the intervention on the infection rate. in order to determine the percentage of individuals who would not otherwise avoid hospitalization but for the intervention, the model multiplies the estimated decrease in infection rate271 by the estimated hospitalization rate by state.272 the mean hospitalization rate was used; where data was not reported, the model used the national average.273 the average cost of a covid-19 hospitalization was $23,489.274 a percentage of total cases were considered to be “public costs.” assuming constant rates of public expenditure, 41% of these costs are considered public costs based on the percentage of covid cases that have been covered by medicaid, medicare, and for uninsured individuals.275 4. additional limitations this analysis is further limited by insufficient data on the outcomes of eviction and displacement. it, therefore, is likely to understate the costs avoided by evictions avoided. this is particularly true given the limited academic research on outcomes for those who do not go through the formal legal process of eviction and/or those who do not end up homeless. indeed, it was difficult to estimate commensurate mental health, chronic health, foster care, and criminal costs for the estimated 78% of people facing eviction who likely do not ultimately 266. sheen et al., supra note 261, at 7. 267. id. 268. see supra part ii.b (describing eviction risk). 269. sheen et al., supra note 261, at 7. 270. id. 271. us currently hospitalized, covid tracking project, https://covidtracking.com/ data/charts/us-currently-hospitalized [https://perma.cc/8xj6-v9kz] (last visited apr. 7, 2021). 272. id. 273. id. 274. chris sloan et al., covid-19 hospitalizations projected to cost up to $17b in us in 2020, avalere (june 19, 2020), https://avalere.com/insights/covid-19-hospitalizations-projectedto-cost-up-to-17b-in-us-in-2020 [https://perma.cc/g6f3-anb7]. 275. id. 354 indiana health law review [vol. 18:293 experience homelessness. the model does not incorporate any estimates to that effect. simply put, the costs are likely to be much greater. additionally, the model does not include a significant number of public costs that would be avoided, including education costs, juvenile justice costs, and welfare system costs associated with homelessness and displacement. it also does not consider future economic consequences that affect tenants’ credit and ability to rent new units. it does not measure the costs of family and community instability if the tsunami of evictions were allowed to hit uninterrupted. can we trust consumers with their brains: popular cognitive neuroscience, brain images, self-help and the consumer can we trust consumers with their brains? popular cognitive neuroscience, brain images, self-help and the consumer* tracy d. gunter** i. introduction ................................... 483 ii. the brain's rise to prominence ................. 486 iii. the brain as a rock star ....................... 497 iv. the rise of the neuros and neuro self-help.......503 a. the market for brain self help products ............. 506 b. examples of commercial brain products..............509 v. brain self-help consumers and consumer protection ............................... ..... 514 a. why protect the brain self-help consumer?........518 b. examples of information offered to consumers... 523 c. enhancing consumer literacy ....... ........ 532 vi. mechanisms of consumer protection ..... ...... 537 a. self-regula tion and soft la w ...... ............... 539 b. direct regulation........................... 541 c ces devices:an example ofregulation and enforcement.. ................................ 543 vii. conclusion .............................. ...... 550 i. introduction cognitive neuroscience captures the imagination by exploring connections between the physical brain and the abstract mind. through recent advances in functional * © 2014 tracy d. gunter. all rights reserved ** tracy gunter, m.d., associate professor of clinical psychiatry at the iu school of medicine, adjunct professor of law, indiana university robert h. mckinney school of law, e-mail tdgunter@iupui.edu. i thank research assistants emily steeb and scott spicer for editorial help and nicolas terry for his valuable comments on an earlier draft. indiana health law review neuroimaging, the living and acting brain comes to life like never before through vivid pictures. brain images are seen with regularity in movies, television shows, consumer product advertisements and popular news reports. against a backdrop of truly exciting brain science, popular rhetoric evokes an illusion that neuroscience has provided a roadmap connecting biology to mentation.1 according to popular brain rhetoric, 2 the active, interconnected, and healthy brain produces an authentic self, and the dimly lit or dysfunctional brain is to blame for unhappiness, failure, and a host of social problems. 3 the responsible citizen is then tasked with the care and development of the brain, 4 and many brain self-help products have appeared on the market making claims that they change mental states and abilities by changing the physical brain.5 recent events suggest that brain self-help may not be innocuous. self-help author james ray declared that science indicated everything was energy and that all reality was self-generated by the power of the human mind. although safety and efficacy concerns were raised about his methods as early as 2000, it was not until three people died and dozens more were hospitalized during a sweat lodge ritual in 2009 that his practice came to a halt.6 concerning foods and supplements, energy drinks promising alertness and focus have now been implicated in dozens of injuries and deaths and herbal remedies have been linked to 1 see kitty holman, coverage of neuroscience in the popular media the new psychobabble, brain blogger (mar. 19, 2011), http://brainblogger.com/2011/03/19/coverage-of-neuroscience-in-thepopular-media-the-new-psychobabble, archived at http://perma.cc/5yzcgssm; david p. mccabe & alan d. castel, seeing in believing-' the effect of brain images on judgments of scientific reasoning, 107 cognition 343, 344 (2008). 2 see generally davi johnson thornton, brain culture: neuroscience and popular media (2011). 3 see generally raymond tallis, aping mankind: neuromania, darwinitis, and the misrepresentation of humanity (2012). 4 thornton, supra 2, at 87. 5 see infra part iv. 6 craig harris & dennis wagner, sweat-lodge guru: a story of ups, downs, ariz. republic, oct. 23, 2009. 484 vol. 11:2 can we trust consumers with their brains? increases in toxic hepatitis (liver inflammation).7 people have also experienced argyria (blue or gray skin caused by silver deposition) and other significant side effects from the ingestion of silver, advertised as a cure-all. 8 yet, consumer demand for brain self-help products remains high and is expected to continue to grow. marketing rhetoric typically attempts to convince self-help consumers that using these products will allow them to outsmart their doctors, foil the pharmaceutical industry, and provide them with risk-free care and enhancement. 9 this situation is far from unique to brain self-help products, but disorders of the brain are common and costly, the level of misinformation and fervor for the subject is high, and the sources of credible information are difficult to locate and navigate. in this paper i argue that the brain has risen to prominence, that misinformation about the brain has become rampant, and that this misinformation combines with other factors and contributes to consumer susceptibility to the aggressive and misleading marketing of brain-themed products. in the sections that follow, i consider the position of the consumer and protection strategies as they currently exist and conclude with recommendations to improve consumer information in the belief that consumers can be trusted with their brains. 7 anahad o'connor, spike in harm to liver caused by dietary aids, n.y. times, dec. 22, 2013, at al; christine a. haller, making a diagnosis of herbal-related toxic hepatitis 176 w. j. med. 39-44 (2002). energy 'drinks" and supplements: investigations of adverse event reports, u.s. food & drug admin. (nov. 16, 2012), http://www.fda.gov/food/newsevents/ucm328536.htm, archived at http://perma.cc/s55a-jfmu. 8 stephen barrett, colloidal silver: risk without benefit, quackwatch, http://www.quackwatch.org/olquackeryrelatedtopics/ phonyads/silverad.html (last updated august 17, 2005), archived at http://perma.cc/83vc-5jr2. 9 stephen barrett & william t. jarvis, how quackery sells, http://www.quackwatch.com/o1quackeryrelatedtopics/quacksell.htnl (last updated jan. 20, 2005), archived athttp://perma.cc/n7ja-xwqk. 2014 485 indiana health law review ii. the brain's rise to prominence people are justifiably hungry for progress in understanding the human brain and behaviors arising from its function. from describing possible biological underpinnings of crime to treating mental illness, advances in brain science have the potential to reduce suffering and save society billions of dollars. biobehavioral' 0 illness, for example, affects 1.5 billion people worldwide," accounts for billions of dollars in costs in the united states alone,12 and is a leading cause of morbidity worldwide, yet progress in understanding and treating biobehavioral disorders has lagged behind other areas of medicine. 13 in fact, some scientists and pharmaceutical companies are withdrawing because of the complexity of the field, immaturity of the science, and formidable barriers to the translation of science into effective treatments.14 other researchers and firms are apparently retooling (i.e. moving away from attempting to use traditional pharmaceuticals to effect change in brain 10 in this work, biobehavioral disorders are defined as those disorders involving behavioral signs and symptoms that are inseparable from the biological substrates underlying them. biobehavioral is an adjective that has been part of the medical literature since the 1970s and tends to denote a rejection of mind-body dualism. see generally kenneth e. freedland et al., what's in a name? psychosomatic medicine and biobehavioral medicine, 71 j. biobehavioral medicine 1 (2009); alan i. leshner, addiction is a brain disease, issues in science & technology, http://www.issues.org/17.3/leshner.htm (last visited apr. 3, 2014), archived at http://perma.cclnay5-jdmh. 11 leanna read et al., brain and mind disorders: impact of the neuroscience 11 (2003). 12 enita a. williams, good, better, best: the human quest for enhancement 7 (mark s. frankel ed., 2006), available at http://www.aaas.org/sites/default/files/migrate/uploads/hesummaryrep ort.pdf, archived at http://perma.cc/f3k9-98wm. 13 bruce n. cuthbert & thomas r. insel, toward the future of psychiatric diagnosis: the seven pillars of rdoc, bmc medicine, may 14, 2013, at 6. 14 steven e. hyman, psychiatric drug development: diagnosing a crisis, the dana found. (apr. 2, 2013), http://www.dana.org/news/ cerebrum/detail.aspx?id=41290, archived at http://perma.cclmb9etvbf. vol. 11:2486 can we trust consumers with their brains? chemistry and toward the use of neuromodulation devices and genetic technologies to effect change in brain networks). attempts to facilitate progress in the area of brain science began more than twenty years ago. president george h. w. bush proclaimed 1990 through 2000 to be the decade of the brain, prioritizing brain research, enhancing public awareness, and encouraging dialogue about emerging discoveries.' 5 major advances achieved during the decade of the brain included recognition of the importance of behavioral genetics, development of brain-computer interfaces, recognition of neurogenesis, and growth of functional magnetic resonance imaging ("fmri"). 16 some credit this as the time period in which mental illness became recognized as a brain disorder. 17 although not endorsed as such by the clinton administration despite some bipartisan support, the american psychological association, in collaboration with more than thirty professional societies, proclaimed 2000 through 2010 to be the decade of behavior. this decade focused on the role of behavioral and social science in addressing societal challenges by "promoting a healthier nation, a safer nation, a better educated nation."' 8 lecture series and publications tackled issues such as feminism, racism, sexuality, childhood stress, memory and cognition, sleep, social isolation in health, self-management of chronic 15 murray goldstein, decade of the brain: an agenda for the nineties, 161 w. j. medicine 239, 239 (1994). 16 the top 10 discoveries from decade of the bram, the infinite brain (may 23, 2001), http://www.theinfinitemind.com/mindl68.html, archived at http://perma.ccly476-cub9. 17 thomas r insel, understanding mental disorders as circuit disorders in a decade after the decade of the brain, the dana found., http://www.dana.org/uploadedfiles/newsand_publications/ cerebrum/decadeafterdecadebraincomplete.pdf, archived at http://perma.cc/f72a-ycp6. 18 b. azar, apa ushers in the 'decade of behavior' 31 monitor on psychology 10, (2000), available at http://www.apa.org/monitor/j anoo/decade-of-behavior.aspx, archived at http://perma.cc/932t-msls. 2014 487 indiana health law review disease, and public opinion formation and change. 19 exploring behavior week was a specific initiative that provided materials for an encouraged university faculty and students in behavioral sciences to reach out to secondary school students to stimulate interest in the field.20 grass roots groups such as mental health america and the national alliance on mental illness have also supported public education about the biological nature of mental illness and research in biobehavioral disorders. 2 1 these outreach efforts have likely resulted in increased public support for parity in the treatment of biobehavioral disorders, described by some as the greatest single advance of 2013.22 in early 2013, president obama announced the brain research through advancing innovative neurotechnologies ("brain") initiative as evidence that government is "invest[ing] in the best ideas,"23 and the national institute of mental health announced a decade-long project to develop a research framework based on biological 19 keren yairi, decade of behavior moves onward, 16 psychol. scl. agenda (2003); siri carpenter, behavioral science claims the decade, 31 monitor on psychology (2000). 20 karen yairi, decade of behavior year two and beyond in division dialogue jan 2002 in the section 1rom the science directorate, am. psychological ass'n (jan. 2002), http://www.apa.org/about/division/ officers/dialogue/2002/01/science.aspx, archived at http://perma.cc/b6ab7cqf. 21 get info, mental health am., http://www.mentalhealthamerica. net/go/information/get-info (last visited apr. 4, 2014), archived at http://perma.cc/zhe7-26pj; about research, nat'l alliance on mental illness, http://www.nami.org/template.cfm?section=aboutresearch (last visited apr. 4, 2014), archived at http://perma.cclu959-vlnr. 22 thomas r. insel, director's blog: ten best of 2013, nat'l inst. of mental health (dec. 13, 2013), http://www.nimh.nih.gov/about/ director/2013/ten-best-of-2013.shtml, archived at http://perma.cc/9d2pzf3y. 23 barack obama, u.s. president, 2013 state of the union (feb. 12, 2013); see also john markoff, obama seeking to boost study of human brain, n.y. times (feb.17, 2013), http://www.nytimes.com/2013/02/18/ science/proj ect-seeks-to-build-map-of-human-brain.html?smid=pl-share, archivedathttp://perma.cc/sdh5-hvur. 488 vol. 11:2 can we trust consumers with their brains? constructs 24 rather than largely subjective symptoms traditionally used in the clinical diagnostic manual, american psychiatric association's diagnostic and statistical manual of mental disorders, currently in the fifth edition (dsm-5).25 the new edition of dsm-5 itself was newsworthy. more than 10,000 public comments were received and reviewed and newspapers such as the wall street journal and new york times published several articles critiquing the manual before it was generally released. 26 by the end of 2013 several initiatives were in place with the hope of facilitating brain research by simultaneously improving current understanding of brain anatomy and physiology, developing measurable signs of brain dysfunction and better outlining clinical behavioral phenomenology. the neurotech industry is worth approximately $110 billion, with approximately $5 billion in public funding. 27 groundbreaking advances flowing from this investment are indeed newsworthy. some recent examples of specific 24 research domain criteria (rdoc), nat'l inst. of mental health, http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml (last visited apr. 4, 2014), archived at http://perma.cc/ka52-hkqy. 25 am. psychiatric ass'n, diagnostic and statistic manual of mental disorders (5th ed. 2013). 26 arthur caplan, viewpoint: stop critiquing the dsm 5, time (may 21, 2013), http://ideas.time.com/2013/05/21/viewpoint-stopcritiquing-the-dsm-5/, archived at http://perma.ccrp5p-uyuy; paul mchugh, wall st. j. (may 17, 2013, 9:40 pm), http://online.wsj.com/news/articles/sb1000142412788732421600457848 3391664789414, archived at http://perma.cc/76ut-eerw; allen frances, diagnosing the d.s.m, n.y. times, (may 11, 2012), http://www.nytimes.com/2012/05/12/opinion/break-up-thepsychiatricmonopoly.html, archived at http://perma.cc/r2sn-s3np, sally l. satel, why the fuss over the d.s.m-5, n.y. times (may 11, 2013), http://www.nytimes.com/2013/05/12/opinion/sunday/why-the-fussover-the-dsm-5.html, archived at http://perma.cc/jq6m-727u, benedict carey, psychiatry manual drafters back down on diagnoses, n.y. times (may 8, 2012), http://www.nytimes.com/2012/05/09/health/dsmpanel-backs-down-on-diagnoses.html, archived at http://perma.cc/a9avlej8. 27 williams, supra note 12, at 7. 2014 489 indiana health law review innovations in neuroscience include the human connectome project and clarity. 28 the human connectome project is a multi-year investment of $30 million of public funds with a goal of mapping the human brain using structural and functional magnetic resonance imaging as well as magnetoand electroencephalography. during 2013, clarity scientists discovered how to replace fat in a post-mortem brain with clear plastic to produce a see-through three-dimensional brain that maintains its shape. advances made during these and. other studies will significantly improve the understanding of the brain in illness and in health. as understanding the structure of dna helped scientists ask better questions about genetic regulation and resulting phenotype, so a better understanding brain structure and function will help scientists ask better questions about neural regulation and resulting attitudes and behaviors. the task of communicating scientific advances about the human brain to the public is complex, involving journalists, scientists and evolving information systems. while communication patterns between scientists and the media have not changed significantly in many years, the world of public communication has been transformed by online communications. 29 in the modern world of the internet, scientific, educational and cultural information mix in an environment "dominated by characteristics adapted from 28 the human connectome project, www.humanconnectome.org (last visited apr. 4, 2014), archived at http://perma.cc/qu9a-vw2a; the human connectome project: relating brain circuits to behavior, david van essen tedx talks (jan. 18, 2013), http://tedxtalks.ted.com/video/the-humanconnectome-project-re (last visited apr. 4, 2014), clarity: hydrogel process developed at stanford creates transparent brain, stanford sch. of medicine (apr. 10, 2013), http://med.stanford.edu/ism/2013/april/clarity.html, archived athttp://perma.cc/ae4d-wgc9. 29 hans peter peters, gap between science and media revisited: scientists as public communicators, 10 proc. nat'l acad. sci. 14102 (supp. 2013). 490 vol. 11:2 can we trust consumers with their brains? entertainment, marketing and retailing cultures and media."3 0 at its best, scientific journalism facilitates the discussion of complex issues such as the public conversation concerning the possible interrelationships between prevalence of firearms, assessment and treatment of mental illness, and violence. at the other extreme are news-like pieces suggesting that people are rightor leftbrained, that the brain has a "god spot" and that neuroimaging can read the content of thought.si because cognitive and social neurosciences strive to "provide neural explanations for basic human behaviors and social norms," advances in this area seem applicable to a wide variety of social issues. 32 advances in neuroscience may ultimately challenge some of society's long held assumptions about behavior. 33 the allure of understanding social convention and human behavior perhaps makes this science particularly prone to sensationalism and speculation. 34 in concluding a recent study of neuroscience in the popular press, researchers noted that "it seemed clear that research was being applied out of context to create dramatic headlines, push thinly disguised ideological 30 nicolas p. terry, cyher-malpractice: legal exposure for cybermedicine, 25 am. j. l. & med. 327, 334 (1999). 31 see, e.g., joe shute, are you right-brained or left-brained, telegraph (dec. 13, 2013, 11:55 am), http://www.telegraph.co.uk/telegraphtv/goodtoshare/10515373/are-you-right -brained-or-left-brained.html; jeremy hsu, scientists locate 'god spot' in human brain, foxnews.com (march 10, 2009), www.foxnews.com/story/2009/03/10/scientists-locate-god-spot-in-humanbrain, archived at http://perma.cc/fxf3-5pmc; mind-goggling, economist (oct. 29, 2011), www.economist.comlnode/21534748, archived at http://perma.cc/5wmz-hnc7. 32 emma zimmerman & eric racine, ethical issues in the translation of social neuroscience: a policy analysis of current guidelines for public dialogue in human research, 19 accountability in res. 27, 28 (2012) sa id. 3 jean liu, interactions: the magic word is 'neuroscience' altmetric (nov. 30, 2012), http://www.altmetric.com/blog/interactionsthe-magic-word-is-neuroscience, archived at http://perma.cc/6a73mpvu. 2014 491 indiana health law review arguments, or support particular policy agendas." 35 although bringing a novel point of view to a discussion may be a reasonable journalistic goal, many scientific experts fear that these misrepresentations of neuroscience may, in fact, slow or stymie true innovation.36 however, it would be an error to conclude that the brain's prominence in popular culture arises only from advocacy groups, the popular press and government initiatives. 37 as innovation has proven difficult and public funding for scientific innovation has plateaued or declined, 38 scientists have become increasingly responsible for translating their work into public health outcomes and generating money at increasingly early stages in the scientific enterprise. 39 the use of persuasive discourse in science has, therefore, become much more prevalent, and at least a part of the "hype" generated around biotechnology may come from scientists themselves. 40 traditionally, scientists have tended to view communication with the public as distinct from communication within the scientific community. although some scientists might hype advances, others tend to be ambivalent about involvement with the media. many scientific experts feel a sense of responsibility to educate the 35 cliodhna o'connor et al., neuroscience in the public sphere, 74 neuron 220, 225 (2012). 36 see bradley voytek, a neuroscientific renaissance, oscillatory thoughts: thoughts of a neuroscientist (july 2, 2011), http://blog.ketyov.com/2011/02/neuroscientific-renaissance.html, archived at http://perma.cc/9vzl-4cvb. 3 see garret o'connell et al., the brain, the science and the media, 12 embo rep. 630 (2011). 38 see kenneth d. harrison et al., building a life sciences innovation ecosystem, scl. translational med., oct. 24, 2012, at 157. 39 see generally sarah zhang, social scientists hit back at grant rules, 503 nature 179, 179 (2013); ahmed zewail & maha zewail, science for the "haves" 52 angewandte chemie int'l edition 108 (2013). 40 zubin master & david b. resnik, hype and public trust in science, 19 sci. & engineering ethics 321, 322-23 (2013).. vol. 11:2492 can we trust consumers with their brains? public about important progress in the area, 41 yet frequently have little experience in public communication and fear misrepresentation.42 although scientists and journalists both search for truth by analyzing facts, the level of certainty required and means of expression of each are different. media reporting frequently proceeds from one big headline of an evolving story to the next, while science proceeds incrementally, over long periods of time, arriving at certainty well after the novelty of the initial experiment.43 from the perspective of the scientist, dissemination of new information to the public should only occur after scientific goals have been achieved and validated. the process of going from idea to theory to fact is generally reserved for debate within the scientific community.44 while scientists and journalists both value being the first to discover something, they cope with it differently. the journalist may value publishing novel, and sometimes speculative, information in public outlets, while the scientist copes by keeping findings private until there is acknowledgement of discovery within the scientific community. the increase in the engagement and involvement of the public facilitated by popular media may reflect a more general trend toward democratization of neuroscience, which potentially facilitates innovation. evidence of democratization includes increasing do-it-yourself hobbyists, open access research, published data sets, public 41 the wellcome trust, the role of scientists in public debate, summary of findings and executive summary, research study conducted by mori 3 (2000). 42 see generally richard hayes & daniel grossman, a scientist's guide to talking with the media (2006); joanna m. wardlaw et al, "can it read my mind?" what do public and experts think of the current (mis)uses of neuroimaging? 6 plos one, e25829 (2011), http://www.plosone.org/article/fetchobject.action?uri=info%3adoi %2f10.1371%2 fjournal.pone.0025829&representation=pdf, archived at http://perma.cc/l3mv-guhg. 43 jim hartz & rick chappell, worlds apart: how the distance between science and journalism threatens america's future 13 (1998). 44 peters, supra note 29. 2014 493 indiana health law review participation in research design, and crowdsourcing. 45 these signs of a shift to a more open model of the practice of science may result in the emergence of new mechanisms of innovation, along with some likely errors along the way. while some level of hype is a normal and expected part of the development cycle of novel technologies, a middle ground must be found between offering no opinions beyond hard data and exaggerating facts to facilitate wild predictions of an improbable future. of particular concern is the risk that hype "could result in either premature translation of research or drive the market towards providing unproven or potentially fraudulent treatments to the public."46 so, what is new about neuroscience? recent advances in neuroscience bring together the concepts of mind and brain in an unprecedented way. from a scientific standpoint, "the brain is the organ of the mind."4 7 this understanding of mind and brain in science dates back to the days of hippocrates and has been reiterated throughout history.48 the scientific desire to localize the physical seat of the mind or soul was largely met with frustration while scientists could only explore the human brain after death and lacked adequate animal models of emotion and cognition. mainstream science has embraced a view of the brain as a unique, genetically active tissue that is constantly "on" and multitasking during life. just as there are no single genes underlying complex biobehavioral disorders, there is no single brain area devoted to complex cognition and decision-making. modern neuroscience is really about 45 see, e.g., neuroscience startups, angellist, https://angel.co/neuroscience (last visited apr. 5, 2014); see also neuroscience research accelerator, indiegogo, http://www.indiegogo.com/projects/neuroscience-research-accelerator (last visited apr. 5, 2014). 46 master, supra note 40. 47 sunil k. pandya, understanding the brain, mind and soul: contributions from neurology and neurosurgery, 9 mens sana monographs 129, 139 (2011). 48 id. vol. 11:2494 can we trust consumers with their brains? understanding and embracing complexity, not about modular localization or simplification. innovations in neuroimaging have already facilitated a greater understanding of the ways in which brain tumors, injuries and illnesses change brain structure and function, allowing clinicians and researchers to correlate self-reported symptoms with observed areas of dysfunction or injury. neurosurgical planning is more precise than ever before, and patients facing these procedures are provided with more detailed education about what to expect. in addition to understanding more about the brain by studying brain illness and injury, researchers also study variations in brain function in groups of healthy study subjects reliably performing specific study procedures to attempt to delineate mechanisms of physical brain function with mental function. 49 fmri studies combine neuroimaging with behavioral tasks to make inferences about differential activity in brain networks separating the study from control groups. the researcher then has the tasks of defining meaningful change and separating that from random fluctuation within and between the study groups. the researcher must then decide whether the meaningful changes observed between groups may be attributed to the performance of the task. fmri measures changes in blood flow and deoxygenated hemoglobin in blood as it circulates through the physical brain at rest and during performance of specified activities. researchers infer that a transient increase in blood flow with increased concentrations of hemoglobin lacking oxygen 49 see sally satel & scott 0. lilienfeld, brainwashed: the seductive appeal of mindless neuroscience xiv (2013). "the goal of brain imaging is enormously important and fascinating: to bridge the explanatory gap between the intangible mind and the corporeal brain." id. for further discussion on the topics discussed in the rest of this section, see id. at ch. 1, taylor, supra , at ch. 14; nikos k. logothetis, what we can do and what we cannot do with mri, 453 nature revs. 869 (2008); nikos k. logothetis, what we can do and what we cannot do with 1mri nature: supplementary information, http://www.nature.com/nature/journal/v453/n7197/extref/natureo697 6-si.pdf, archived at http://perma.cc/xu58-lxb7. 2014 495 indiana health law review is an indication of neuronal oxygen use. further, researchers assume that neuronal communication accounts for the perceived oxygen use. the area of change is then identified as a bright spot. interpretation of this signal is made more difficult by stray signal or noise that may be picked up during the detection of the signal of interest. thus, an experiment may be repeated several times in an attempt to identify pertinent signal and separate it from other activity and background noise. even with advanced resolution, these "bright spots," measured in voxels on a generated brain image, reflect the function of thousands of neurons and millions of synapses (i.e., connections). an active neuron may increase, inhibit, or modulate regional activity consequently neuronal activity and neurotransmission are not synonymous. neurons communicate by electrical and chemical mechanisms, which occur at generally faster rates (and thus over a shorter time period) than blood flows and oxygen perfusion changes. in order to further investigate these associations, some research paradigms use both measures of fast-changing brain cell electrical activity such as electroencephalography (eeg) or magnetoencephelography (meg) and slower changing fmri to study the complex and interconnected communication systems of the brain. these networks are always "on" and multitasking during life so a "bright spot" is never the only functioning part of the brain, but rather it is a rather large area that is statistically different from the rest. the fact that the technology has sufficiently progressed so that researchers can see differential activity in a living complex system is amazing, but the perception that these technologies provide transparent windows into humanity and behavior at the level of the individual is grossly inaccurate.5 0 brain function studies remain relatively gross and indirect measures of how the physical brain works. 50 davi a. johnson, the rhetorical brain: articulating mind and matter in contemporary neuroscience 15, 36, 41, 43 (2013), available at https://getd.libs.uga.edu/pdfs/johnson-davi-a 200608 phd.pdf, archived at http://perma.cc/s26q-j7jb. vol. 11:2496 can we trust consumers with their brains? similarly, performance on a study task provides incomplete information about how people behave in real-world situations. additionally, the data produced by these technologies are remarkably complex and the analytic procedures used to generate some of the commonly seen pictures on the internet are based on a number of evolving assumptions. consequently, drawing conclusions about brain function in everyday life is fraught with difficulty. the limitations of the science not withstanding, the rhetorical brain is now not only seen as part of the body, but as the seat of humanity (i.e. the individual's thoughts, behaviors, feelings, and decisions).51 although some worry that an over-reliance on biological explanations of cognition and emotion will lead to a devaluation of the human experience, 52 others argue that the drive to know the brain is fundamentally a human pursuit, adding complexity to explanations of human experience and satisfying the human being's deepest curiosity. 53 while it would be more satisfying to believe that the increases in mentions of the brain in communications and in the public's interest in the brain is driven by a genuine interest in the richness of neuroscientific data and the complexity of the human experience, the reality seems to be that brain rhetoric leverages biological supremacy to serve more proximate goals such as improving the self, differentiating social groups, making products more marketable, making arguments more convincing, and making entertainment more entertaining. 54 iii. the brain as a rock star just as the number of mentions of neuroscience or the brain has risen dramatically in recent years in news reports 51 raymond de vries, who will guard the guardians of neuroscience, 8 eur. molecular biology org. s65, s65-s69 (2007). 52 see generally tallis, supra note 3, 53 see generally pandya, supra note 47. 54 see o'connor et al., supra note 35, at 225-26. 2014 497 indiana health law review and blogs, so the use of brain images has increased in entertainment and advertising. movies such as the brain that wouldn't die, donovan's brain, fiend without a face, the man with two brains, and the city oflost children used bodiless, communicating and sometimes renegade brains as plot elements. 55 brainscan is a movie in which a gamer commits murders believed to be part of video game by the same name.56 the exorcist showed a now obsolete brain imaging technology (pneumoencephelography) in the evaluation of the protragonist's behavior changes.5 7 in the walking dead, magnetic resonance images of the brain showed black spots, indicating impending zombification. brain damage explores addiction through a brain eating reptile that offers the host euphoria in exchange for a steady supply of other human brains. 58 inception, trance, total recall, the bourne identity, and eternal sunshine of the spotless mind feature memory alteration.5 9 limitless and side effects use brainaltering medications to advance plots.60 other movies such as awakenings, the notebook, driving miss daisy, and a beautiful mind explore the, at times, devastating effects of biobhehavioral illness. 61 allusions to brain and neurological s5 the brain that wouldn't die (sterling productions 1962); donovan's brain (dowling productions 1953); friend without a face (amalgamated productions 1958); the man with two brains (aspen film society & warner bros. 1983); the city of lost children (centre national de la cin6matographique 1995). 56 brainscan (admire productions ltd. 1994). 57 the exorcist (warner bros. & hoya productions 1973). 5s the walking dead (amc studios 2010); brain damage (palisades entertainment group 1988). so inception (legendary pictures & syncopy films 2010); trance (cloud eight films 2013); total recall (carolco pictures & studiocanal 1990); total recall (original film 2012); the bourne identity (the kennedy/marshall company & filmcolony 2002); eternal sunshine of the spotless mind (anonymous content & this is that 2004). 60 limitless (virgin produced et al. 2011); side effects (endgame entertainment et al. 2013). 61 awakenings (lasker/parkes productions 1990); the notebook (avery pix 2004); driving miss daisy (the zanuck company 1989); a beautiful mind (imagine entertainment 2001). vol. 11:2498 can we trust consumers with their brains? function can be more subtle. the scarecrow from the wizard of oz said that he could be of more help "if i only had a brain."6 2 avatar featured mind-control when the main character guided his flying horse by plugging in his ponytail.63 many television shows appealing to all ages feature the brain. brain of morbius, a 1976 four-part episode of doctor w1ho, centered around the brain of an evil alien kept alive by artificial means.64 star trek episodes used brain images and mind manipulation on a relatively regular basis. 6 5 two examples are the disembodied brain of mr. spock in the episode spock's brain from the original series and the rendering helpless of the crew in "the game" from star trek: next generation.66 a friends episode centered on joey's "new brain."6 7 other shows such as the simpson's and south park present comic views of this evolving science, with jokes about homer's brain68 and cartman's v-chip.6 9 the long running television show pinky and the brain70 portrayed the exploits of two genetically enhanced laboratory mice escaping each night to attempt to take over the world and offered rather detailed information about the brain in "brainstem" as sung by brain. 71 "the brain 62 the wizard of oz (metro-goldwyn-mayer 1939). 63 avatar (lightstorm entertainment et al. 2009). 64 doctor who: the brain of morbius (bbc television broadcast jan. 3, jan. 10, jan. 17, jan. 24, 2004). 65 star trek: the next generation (paramount television 1987). 66 star trek: the next generation: the game (cbs television broadcast oct. 26, 1991). 67 friends: the one with joey's new brain (nbc television broadcast feb. 15, 2001). 68 the simpsons: brother from the same planet (fox broadcasting company television broadcast feb. 4, 1993); the simpsons: homr (fox broadcasting company television broadcast jan. 7, 2001). 69 south park: bigger, longer, and uncut (paramount pictures 1999); south park: i should have never gone ziolining (comedy central apr. 18, 2012); south park: poor and stupid (comedy central oct. 6, 2010). 70 pinky and the brain: brainstem (warner brothers television broadcast sept. 17, 1995). 71 id. 2014 499 indiana health law review surgeon" character was one of the scariest in the hit series dexter.72 cbs aired 3 lbs., a short-lived series about the lives of neurosurgeons. 73 perception has recently been renewed for its third season and features an eccentric neuroscientist aiding the fbi in solving of crimes. 74 television and movies are not the only sources of brain entertainment. graphic novels and anime figures also explore themes of brain, brain control, and superiority through brain optimization.7 5 the anime character neuro, who feeds on the mysteries of the human mind, is a prominent example. 76 a few examples of brain-themed games include big brain academy, brainbashers, and brain boost.7 7 turning to popular music, mentions of the brain may reference brain injury, drug use, strong emotion, mental illness, and sociopolitical themes to name but a few references and themes. references to the brain may occur in band names such as bad brains and no brain. album titles featuring the brain include emerson, lake and palmer's brain salad surgery and funkadelic's maggot brain.78 song titles may also mention the brain. the ramones song "my brain is hanging upsidedown" describes 72 dexter (showtime networks et al. 2006). 73 3 lbs. (the levinson/fontana company 2006). 74 perception (paperboy productions & abc studios 2012). 75 see phi brain anime gets 3rd series in 2013, anime news network (sept. 23, 2012, 8:03 am), http://www.animenewsnetwork. comlnews/2012-09-23/phi-brain-anime-gets3rd-series-in-2013, archived at http://perma.cc/r22n-pfbf; brain (comics), wikipedia, http://en.wikipedia.org/wiki/brain_(comics) (last updated apr. 4, 2014), archived at http://perma.cc/4td2-hffb; brain boy, wikipedia, http://en.wikipedia.org/wiki/brain-boy (last updated oct. 4, 2013), archived at http://perma.ccl95qc-njw6; professor x 1 marvel, http://marvel.com/universe/professorx (last visited apr. 5, 2014), archived athttp://perma.ccl3kqy-jxuc. 76 neuro nogami, wikipedia, http://nogamineuro.wikia.com/wikil neuro_n6gami (last visited nov. 5, 2013). 77 big brain academy (nintendo 2005); brainbashers, http://www.brainbashers.com (last visited apr. 8, 2014), archived at http://perma.cc/3g4p-v7lw; brain boost (nintendo 2006). 78 emerson, lake and palmer, brain salad surgery (manticore records 1973); funkadelic, maggot brain (westbound records 1971). vol. 11:2500 can we trust consumers with their brains? the intense emotions felt by the narrator during a controversial political event.79 green day's "brain stew" describes the narrarator's thoughts and feelings while attempting to fall asleep.80 enigma describes love as "tnt for the brain."8 ' cypress hill's "insane in the brain" has been described as a "diss" song written after the performers perceived others as not understanding or appreciating their music.82 pink floyd's "brain damage" alludes to mental illness and lobotomy, while eminem's "brain damage" mentions traumatic brain injury and drug use.8 3 stephen kellogg recently declared, "the brain is a beautiful thing," while exploring sociopolitical themes. 84 revocation's "the brain scramblers" describes a dystopian world in which "[n]neural transformation" produces an untreatable tormented population. 85 voltaire and jonathan coulton described the thoughts of a zombie in "brains" and "re: your brains" respectively. 86 bob marley's "ganja in my brain," is perhaps the most obvious reference to drug use.87 some consider entertainment devices to be useful in attracting future scientists to the field and creating a "culture of intrigue," which is "where scientific interest and innovation come from."8 8 in addition to generally raising 79 the ramones, my brain is hanging upside down, on animal boy (beggars banquet records 1985). 80 green day, brain stew, on insomniac (reprise records 1995). 81 enigma, tn t for the brain, on le roi est mort, vive le roi! (virgin charisma 1996). 82 cypress hill, insane in the brain, on black sunday (ruffhouse & columbia 1993). 83 pink floyd, brain damage, on the dark side of the moon (harvest & capitol 1973); eminem, brain damage, on the slim shady lp (aftermath et al. 1999). 84 stephen kellogg, the brain is a beautiful thing, on blunderstone rookery (elm city 2013). 85 revocation, the brain scramblers, on existence is futile (relapse records 2009). 86 voltaire, brains!, on boo hoo (projekt records 2002); jonathan coulton, re: your brains, on left 4 dead 2 (valve corporation 2009). 87 ras matthew, ganja in my brain (creation sounds 2008). 88 rachel rettner, top brain science movies revealed, yahoo news (oct. 3, 2013, 8:55 am), http://news.yahoo.com/top-brain-science2014 501 indiana health law review the visibility of the science, some entertainment vehicles deal with brain science in a more serious and accurate way. examples include of popular television series include the brain and behavior research foundation's healthy minds, national geographic's brain games, australian television's redesign my brain, pbs's charlie rose's brain series, bbc's brain story, and the public broadcasting service's frontline offerings "brain wars," "inside the teenage brain," and "league of denial."8 9 recognizing the power of brain images and mentions, industry has reached out to consumers, and their brains, in its own inimitable way. advertisements for lego,90 cars,9 1 and clean energy products 92 suggest that the brain prefers these products. pbs wants to expand the brain, not the waist-line; 93 allstate offers insurance to cover adolescents because parts of their brains are missing;94 and megacom movies-revealed-125554655.html, archived at http://perma.cc/7ncwp24m. 89 healthy minds (brain and behavior research foundation 2013); brain games (national geographic 2011); redesign my brain (australian broadcasting corporation); the brain series (public broadcasting service 2010); brain story (british broadcasting company 2000); frontline: brain wars (pbs television broadcast june 9, 2010); frontline: inside the teenage brain (pbs television broadcast jan. 31, 2002); frontline: league of denial (pbs television broadcast oct. 8, 2013). 90 see lego print ads, a modular life (june 13, 2010, 10:49 pm), https://amodularlife.wordpress.com/2010/06/13/lego-print-ads/, archived at http://perma.cc/j7ll-b32k. 91 see 30 creative car ads, beautiful life, http://www.beautifullife.info/ advertisment/30-creative-car-ads/ (last visited apr. 5, 2014), archived at http://perma.cc/6x3g-t9kz. 92 see richard w. caperton, everyone wins with clean energy standards, grist (nov. 30, 2011, 11:00 pm), http://grist.org/energypolicy/2011-11-30-everyone-wins-with-clean-energy-standards/, archived at http://perma.cc/cv9d-gu5c; general electric, www.ge.com (last visited apr. 5, 2014), archived at http://perma.cc/q5qu-8nfz. 93 see, meghan young, brain boosting campaigns, trendhunter marketing (nov. 12, 2011), http://www.trendhunter.com/trends/pbswhere-television-matters, archived at http://perma.cc/bu3h-6h7k. 94 see a childish view of risk, riskology (feb. 1, 2011), http://risk-ology.com/2011/02/01/a-childish-view-of-risk/, archived at http://perma.cc/956m-qw9n. 502 vol. 11:2 can we trust consumers with their brains? sells refurbished computers using images of freshly ground brain.96 with the ubiquitous presence of mobile computing, people may be exposed to news, entertainment, and marketing materials on an almost constant basis. iv. the rise of the neuros and neuro self-help as a possible side effect of the brain's high visibility, attaching some version of "neuro" to other roots or words has seemingly become a national pastime, and is sometimes called neurofication, 96 neurohype, and neuromania. 97 witty authors wonder whether a neuro-newton will pave the way to neuro-nirvana.9 8 skeptics are now neuroskeptics, 99 or neurophobes, 100 while proponents are neurohawks, 101 95 see advertising agency. "brain" print ad by megacom advertising, coloribus, http://www.coloribus.com/adsarchive/prints/ advertising-agency-brain-3811405/ (last visited apr. 5, 2014), archived at http://perma.ccln9bp-a8sv. 96 neurofication definition, urbandictionary.com, http://www.urbandictionary.com/define.php?term=neurofication (last visited apr. 5, 2014), archived at http://perma.cc/7wjl-bdpu. 7 for neurohype, see, e.g., daniel carlat, brain scans as mind readers? don't believe the hype, wired magazine (may 19, 2008), http://www.wired.com/medtech/health/magazine/16-06/mf neurohacks? currentpage=all; for neuromania, see, e.g., tallis supra note 3, at 5. 98 see scicurious, does neuroscience need a newton., scl. am. (dec. 3, 2012), http://blogs.scientificamerican.com/scicuriousbrain/2012/12/03/does-neuroscience-need-a-newton/, archived at http://perma.cc/p27q-trzs. 9 see christen rachul & amy zarzeczny, the rise of neuroskepticism, 35 int'l j. l. & psychiatry 77 (2012); alicia puglionesi, the seductive allure of neuroskepticism, motherboard (jan. 8, 2013, 2:35 pm), http://motherboard.vice.com/blog/the-seductiveallure-of-neuroskepticism, archived at http://perma.ccdyn5-qytv. 100 see neurophobes and their neurophobia, prof zeki's musings (apr. 6, 2013), http://profzeki.blogspot.com/2013/04/neurophobes-andtheir-neurophobia.html, archived at http://perma.cc/6m89-gu22; ed bullmore et al., w1hy psychiatry can't afford to be neurophobic, 194 brit. j. psychiatry 293 (2009). 101 see carl f. johansson et al., neurohawks fight back, 195 brit. j. psychiatry 268 (2009). 2014 503 indiana health law review neurophiles,102 neuromaniacal, 103 or peddling neurotrash.104 fields of study such as neuroeconomics, 0 5 neuropolitics,10 6 neurorhetoric,1 07 neuroethicslos and neurolaw are now parts of the academic landscape. 109 neuromarket researchers may use imaging to identify brain patterns reflecting consumer preferences. 110 neurocapital is then generated by 102 see the neurophile, http://neurophile.blogspot.com (last updated oct. 7, 2007). 103 see tallis, supra note 3, at 5; nathan emmerich, medical ethics education: an interdisciplinary and social theoretical perspective 100 (2013). 104 see margaret heffernan, beware neurotrash, cbs moneywatch (june 17, 2013, 12:45 pm), http://www.cbsnews.com/8301-505125_16257589570/beware-neurotrash/, archived at http://perma.cc/zqr6-hvlw; brigitte nerlich, making neuroscience public: neurohype, neuroscepticism and neuroblogging, univ. of nottingham blogs (may 15, 2012), http://blogs.nottingham.ac.uk/makingsciencepublic/2012/05/15/maki ng-neuroscience-public/, archived at http://perma.cc/m866-ktva. 105 see neuroeconomics, duke ctr. for interdisciplinary decision sci., http://www.dibs.duke.edu/research/dcides/research/neuroeconomics (last visited apr. 6, 2014), archived at http://perma.cc/dt4u-9pjg; george loewenstein et al., neuroeconomics, 59 ann. rev. psychol. 647 (2008), available at http://www.annualreviews.org/doi/pdf/10.1146/annurev.psych.59.103006 .093710, archived at http://perma.cc/csq9-dt7k; aldo rustichini, neuroeconomics: what have we found, and what should we search for? 19 current opinion neurobiology 672 (2009). 106 see 23 william e. connolly, theory out of bounds: neuropolitics: thinking, culture, speed (2002). 107 see chris mays & julie jung, priming terministic inquiry.' toward a methodology ofneurorhetoric, 31 rhetoric rev. 41 (2012). 10 see walter glannon, neuroethics, 20 bioethics 37 (2006); judy illes & stephanie j. bird, neuroethics: a modern context for ethics in neuroscience, 29 trends neuroscience 511 (2006); martha j. farah, neuroethics: the ethical, legal, and societal impact of neuroscience, 63 ann. rev. psychol. 571 (2012). 109 see j. taylor et al., neuropsychologists and neurolawyers, 5 neuropsychology 293 (1991); susan m. wolf, neurolaw: the big question, 8 am. j. bioethics 21 (2008). 110 see david lewis & darren bridger, market researchers make increasing use of brain imaging, advances clinical neuroscience & rehabilitation, july-aug. 2005, at 36; dan ariely & gregory s. burns, neuromarketing: the hope and hype of neuroimaging in business, 11 nat. rev. neuroscience 284, 284 (2010); anita tusche, neural responses to unattached products predict later consumer vol. 11:2504 can we trust consumers with their brains? identifying the brain activity that is associated with consumer preferences. 111 neuromyths are perhaps an expected side effect. neuromyths are false beliefs about brain function that have become so common that they are no longer questioned. 112 sometimes the result of misinterpreted, miscommunicated, or obsolete science, neuromyths tend to be repetitive, simple, science-sounding statements that make a case for a specific point of view, product or approach. one common neuromyth is that people have right-brain or left-brain personalities and/or learning styles. the title left-brained larry & right-brained rachel, the snowboarding movie left brain right brain, and the nintendo game right brain left brain all exploit this common neuromyth.113 another common misconception is that people only use "about 10%" of the brain. the movie limitless used the neuromyth of untapped potential in the fictional drug advertisement "accessing 100% of your brain is possible."114 regarding human development, a common neuromyth is that there are windows or critical periods of rapid learning followed by times in which new learning cannot occur, leading people to sometimes expose babies to swimming lessons, classical music, foreign languages and mathematical concepts sometimes before they have the choices, 30 j. neuroscience 8024 (2010); andrija javor et al., neuromarketing and consumer neuroscience: contributions to neurology, 13 bmc neurology (2013), http://www.biomedcentral.com/ content/pdf/1471-2377-13-13.pdf, archived at http://perma.cc/z9t78tmg. il see acclair, http://www.acclair.co.uk (last visited apr. 6, 2014), archived at http://perma.cclw33l-dm2z. 112 sanne dekker et al., neuromyths in education: prevalence and predictors of misconceptions among teachers, 3 frontiers psychol. 429 (2012), available at http://www.ncbi.nlm.nih.gov/pmc/articles/ pmc3475349/pdflfpsyg-03-00429.pdf, archived at http://perma.cc/p8y6ezc. 113 left-brained larry & right brain rachel (sandy a. ward), available at https://www.youtube.com/watch?v-h4zpew1setc; left brain right brain (think thank 2010); right brain left brain (nintendo 2007). 114 limitless (virgin produced 2011). 2014 505 indiana health law review ability to sit up in order to make them "smarter." neuro self-help is yet another neuro. 115 neuro self-help products are those products made available directly to the consumer to achieve desired "brain" outcomes for themselves. neuromyths are frequently leveraged by purveyors of neuroproducts in marketing materials, likely due to the simplicity and seeming obviousness of them. neuro self-help, also referred to as "brain-based selfhelp,"116 puts forth the idea that brainpower is the key to solving a problem or difficulty, frequently going on to assert that increasing brainpower takes effort and new products. a. the market for brain self help products while brain self-help products such as brain saltit7 have been parts of our history, the market for these products has experienced double-digit growth rates in recent years, 118 and most recently was estimated to be worth $11-12 billion. 119 the cognitive health food market is worth 115 neuro self-help?, neurosphere (aug. 21, 2011), http://neurosphere.wordpress.com/2011/08/2 1/neuro-self-help/, archived at http://perma.cc/dc8v-w2vk; tnr staff, neuro-self-help, dr. elmo, and a liberal legacy' today's tnr reader, new republic (sept. 26, 2012), http://www.newrepublic.com/article/107733/neuro-self-help-drelmo-and-liberal-legacy-todays-tnr-reader, archived at http://perma.cc/ 52sx-vm7p. 116 davi johnson, "how do you know unless you look?":' brain imaging, biopower and practical neuroscience, 29 j. med. human. 147, 148 (2008). 117 see ferdinand meyer v, francis newbery & sons brain salt, peachridge glass (june 3, 2013), http://www.peachridgeglass.com/ 2013/06/francis-newbery-sons-brain-salt-london/, archived at http://perma.cc/7l9f-t5p8. 118 melanie lindner, what people are still willing to pay for, forbes (jan. 15, 2009, 10:45 am), http://www.forbes.com/2009/01/15/ self-help-industry-ent-sales-cx_mlo15selfhelp.html, archived at http://perma.cc/u4p4-jcux. 119 self-improvement market has unfilled niches for entrepreneurs, prweb (mar. 26, 2012), http://www.prweb.com/ pdfdownload/9323729.pdf. 506 vol. 11:2 can we trust consumers with their brains? another $2 billion, 120 and brain fitness products may add another $1-2 billion.121 although the traditional self-help book and workshop market may be decreasing, 122 every indication is that "functional foods" and brain-training market shares are growing.123 datamonitor predicts that cognitive health foods will grow at more than 10%, outstripping the growth rate of health foods in all other categories.124 what follows is a brief overview of the kinds of products available to consumers seeking brain selfimprovement. though the self-improvement movement has received significant criticism, 125 many consider the drive for selfimprovement to be a fundamentally human endeavor.126 self-care has long been part of our history, 127 and healthcare officials point to consumer self-care as "an important part of efficient and effective healthcare delivery."128 in situations in which consumers have the 120 elaine watson, brain food ripe for growth, but who will lead the charge? nutraingredients (may 12, 2011), http://www.nutraingredientsusa.com/suppliers2/brain-food-ripe-for-growth-but-who-will-lead-thecharge?utm-source=copyright&utm medium=onsite&utm campaign-copy right, archived at http://perma.cc/7r8x-q456. 121 omar ford, brain health market is expected to rapidly grow in next decade, med. device daily (feb. 12, 2013), http://www.medicaldevicedaily.com/servlet/com.accumedia.web.dispatch er?next=bioworldheadlinesarticle&forceid=81869, archived at http://perma.cc/639q-xnr4. 122 see $11 billion self-improvement market moves online, prweb (dec. 1, 2010), http://www.prweb.com/pdfdownload/4847314.pdf. 123 watson, supra note 120; ford, supra note 121; alexandra posadzki, brain fitness targets aging population, winnipeg free press (aug. 19, 2013, 1:00 am), http://www.winnipegfreepress.com/ business/brain-fitness-targets-aging-population-220149541.html, archived at http://perma.cc/j3fz-jrxx. 124 watson, supra note 120. 125 see generally steve salemo, sham: how the self-help movement made america helpless (2005). 126 williams, supra note 12, at 8. 127 see generally charles e. rosenberg, right living: an angloamerican tradition of self-help medicine and hygiene (charles e. rosenberg ed. 2003). 128 mary ellen copeland, u.s. dep't of health & human servs., substance abuse and mental health servs. admin., 2014 507 indiana health law review combination of health literacy and actionable information, self-management of health and wellness are net positives for consumers. the important caveat is that many self-help products make exaggerated or untested claims. 129 the primary consumer goals for brain self-improvement are rather difficult to quantify, but include self-mastery, selfinvention, effective competition, improved quality of life, and emotional and physical security. 130 popular discourse suggests that people must seek more brainpower to be responsible citizens and that neuroscience provides both accessible and actionable information to empower the consumer to meet this responsibility. 131 much like attractiveness, it would seem that there is no such thing as too much brainpower (or mental ability as defined by one or more of the following: improved mood, higher intelligence, more efficient organization, greater motivation, intensified concentration, keener memory, increased processing speed, or the heightened ability to perform a new skill) and little objective way of quantifying it. although maintenance of wellness is frequently touted as a goal of self-improvement, research has shown that those suffering from mental health problems are more likely to turn to complementary or alternative interventions such as those offered by commercial self-improvement products.1 32 recovering your mental health a self-help guide, sma-3504, available at http://store.samhsa.gov/shin/content/smia-3504/sma3504.pdf, archived at http://perma.cclp2tt-kd35. 129 see ben martin, the pros and cons of sef-help books, psych central, http://psychcentral.com/1ib/the-pros-and-cons-of-self-help-books/ 0001074 (last visited apr. 6, 2014), archived at http://perma.cclsa9c-uns3; barrie davenport, 15 darned good reasons why self-help actually helps, live bold & bloom, http://liveboldandbloom.com/01/life-coaching/15darned-good-reasons-why-self-help-actually-helps (last visited apr. 6, 2014), archived at http://perma.cc/gr9u-zwuq; jo ann oravec, on the 'proper use" of the internet: self-help medical information and on-line health care, 14 j. health & soc. pol'y 37 (2001). 130 see williams, supra note 12, at 4-8, 11; johnson, supra note 115, at 148. 1s1 see thornton, supra note 2, at 109, 161. 132 see generally tzipi hornik-lurie et al., use of unconventional therapies by primary care patients: religious resources vs. vol. 11:2508 can we trust consumers with their brains? messages are not all positive, and part of the obligation to enhance the brain flows from the alleged risks in opting out of the enterprise of brain monitoring, training and improvement. 133 according to popular brain rhetoric, if the concerned consumer does not learn to listen to, use, and respond to the brain, then the individual may fail to realize his or her potential, may make self-defeating decisions, and may even inadvertently damage the brain. 134 b. examples of commercial brain products books such as the better brain book,135 change your brain, change your life,13 6 and making a good brain great 137 introduce the reader to the idea that "[y]ou're not stuck with the brain you were born with."138 they might inform the reader that he or she can discover "what your doctor won't tell you about preventing and treating stroke, alzheimer's, parkinson's, and other neurological conditions."13 9 while some offerings tell the reader, "when your brain works right, you work right,"140 others argue complementary or alternative medicine services, 21 complementary therapies med. 517 (2013). 133 see thornton, supra note 2. 134 id. 135 david perlmutter & carol colman, the better brain book: the best tool for improving memory and sharpness and preventing aging of the brain (2005). 136 daniel g. amen, change your brain, change your life: the breakthrough program for conquering anxiety, depression, obsessiveness, anger, and impulsiveness (1999). 137 daniel g. amen, making a good brain great: the amen clinic program for achieving and sustaining optimal mental performance (2006) [hereinafter amen, making a good brain great]. 138 change your brain, change your life. the breakthrough program for conquering anxiety, depression, obsessiveness, anger, and impulsiveness, amazon.com, http://www.amazon.com/dp/ 0812929985/ref-rdrexttmb (last visited apr. 6, 2014), archived at http://perma.cc/9mpt-mdyg. 139 the better brain book, perlmutter health ctr., http://www.perlhealth.com/books/the-better-brain-book/ (last visited apr. 6, 2014), archived at http://perma.cc/8vg-j2wk. 140 amen, making a good brain great, supra note 137, at 7. 2014 509 indiana health law review "[y]ou are [not [y]our [b]rain."141 both sides offer plans to help consumers on the one hand improve how the brain works and on the other hand to overcome "[dieceptive brain messages [that] may be running and ruining your life."14 2 foods, drinks and supplements are commonly used to improve a variety of abilities. drinks such as neurobliss and neurogasm (renamed neuropassion) promise enhancement in a wide range of cognitive and emotional abilities. 143 dietary supplements such as vitamins (e.g. a, b, c, d, e), herbs (e.g. ginko bilboa, kava and ginseng) and phospholipids make a variety of claims from preventing cognitive decline to enhancing current mental abilities. traditional foods that are touted as particularly good for the brain have taken on the moniker "super foods" and include blueberries, avocadoes, and salmon. with names such as focus factor, eureka, brain power, brainalin, and happy pills, consumers are barraged with messages that they can feel better and function better without making any other lifestyle choices save taking these pills or eating these foods. neurosky markets the brainwave starter kit and mindwave mobile allowing the user to observe electrical patterns with the idea that a watched process is a controllable andlor improved process.14 4 brain training and fitness programs promise the consumer that by repeating tasks the consumer expands his or her mind by building more, and better, pathways in the brain.145 the consumer 141 jeffrey schwartz & rebecca gladding, you are not your brain: the 4-step solution for changing bad habits, ending unhealthy thinking, and taking control of your life (2012). 142 sandra pawula, you are not your brain: book review, always well within (june 13, 2011), http://alwayswellwithin.com/2011/06/13/ you-are-not-your-brain-book-review-and-giveaway/, archived at http://perma.cc/slp3-md4e. 143 see, e.g., neuro, http://drinkneuro.com (last visited apr. 6, 2014); jeffrey klineman, neuro: no more gasm, only passion, bevnet (apr. 16, 2012, 11:08 am), http://www.bevnet.com/news/2012/neuro-nomore-gasm-only-passion, archived at http://perma.cc/8apg-qpag. 144 see neurosky, http://www.neurosky.com (last visited apr. 6, 2014), archived at http://perma.cclg99p-2qw7. 145 see brain training apps, app crawlr, http://appcrawlr.com/iosapps/best-free-apps-brain-training (last visited apr. 6, 2014), archived vol. 11:2510 can we trust consumers with their brains? could also turn to emotiv for advice, which says, "[ylou think, therefore, you can." 146 brain sync offers the consumer the chance to participate in conscious evolution, 147 and immrama helps each person "tap into [his or her] infinite potential."148 foods, books and supplements to coax the brain into aiding weight loss are also marketed to consumers 149 as are products that allegedly use subliminal signaling to the brain to make the individual more attractive.1 50 although some products are over-the-counter devices, such as the brain stimulation headset that shines light in at http://perma.cc/fsw7-z6kb; lumosity, www.lumosity.com (last visited apr. 6, 2014), archived at http://perma.cc/w3dz-kney; brainmatrix, www.brainmatrix.com (last visited apr. 6, 2014), archived at http://perma.cc/7b7z-mfrs; games for the brain, www.gamesforthebrain.com (last visited apr. 6, 2014); andrew j. latham et al., the virtual brain: 30 years of video-game play and cognitive abilities, frontiers psychol.,, sept. 2013; brain fitness program, posit scl., http://www.positscience.com/brain-trainingproducts/brain-fitness-program (last visited apr. 6, 2014), archived at http://perma.cc/46ba-fsyy; brain fitness, brain matrix, http://www.brainmetrix.com/brain-fitness/ (last visited apr. 6, 2014), archived at http://perma.cc/jkf8-rpmr. 146 emotiv epoc, http://www.emotiv-epoc.de (last visited apr. 6, 2014), archived at http://perma.cc/apw2-cmlk. 147 brain sync, http://www.brainsync.com (last accessed apr. 6, 2014), archivedathttp://perma.cc/nm5f-krnh. 148 infinity program with gentle rain (mp3), immrama inst., http://www.immrama.org/productcart/pc/viewprd.asp?idproduct=32&idc ategory=#details (last visited apr. 6, 2014), archived at http://perma.cc/43dn-4kqt. 149 see daniel g. amen, the amen solution: the brain healthy way to get thinner, smarter, happier (2011); daniel g. amen, change your brain, change your body: use your brain to get and keep the body you have always wanted (2010); brain-based weight loss, jaudy treatment ctr., http://www.drjaudy.com/brain-basedweight-loss/ (last visited apr. 6, 2014), archived at http://perma.cc/w3cf-jnqj; weight management, mind works, http://store.amenclinics.com/supplements/weight-management/ (last visited apr. 6, 2014), archived at http://perma.cc/7amc-yf7r. 150 increase your sex appeal: combination of subliminal & learning while sleeping program (2013); becoming a master seducer (2012). 2014 511 indiana health law review the ears to lessen sad moods151 or the do-it-yourself neural stimulator made available to satisfy consumer curiosity about their own brains, 152 some brain-themed commercial self-improvement products, such as cranial electrotherapy stimulation ("ces") devices, require a prescription in the united states. 15 3 retailers may sell products directly to consumers from international websites 154 or provide a professional to write the required prescription,1 55 offering a path directly to consumers and evading traditional regulation. today's consumer receives messages about products that reportedly enable him or her to "think smart,"156 play the brain, 15 7 power up the brain, 5 8 use the brain to control 151 see valkee.com, http://valkee.comlen/ (last visited apr. 6, 2014), arclived at http://perma.ccdkt2-7l2t. 152 see nancy a. melville, diy brain stimulation raises concerns, medscape (july 10, 2013), http://www.medscape.com/viewarticle/ 807593. 153 though the intent of this protection was to insure that a consumer-selected provider was involved in the determination of the appropriateness of the device for the individual consumer, the manufacturer or marketer may offer consumers the opportunity to have a prescription written for them using an online provider and usually for an additional fee. 154 see, e.g., sota, http://www.sota.com (last visited apr. 6, 2014), archived at http://perma.cc/867b-97kk. 155 frequently asked questions, how to buy a device, fisher wallace simulator@, http://www.fisherwallace.com/cranialstimulatorfaq (last visited apr. 6, 2014). 156 see richard restak, think smart: a neuroscientist's prescription for improving your brain's performance (2010); think sma4rt for aptitudes, windows, http://apps.microsoft.coml windows/en-us/app/think-smart-for-aptitudes/cl5e7514-569c-4359-a88bob50394b65f9 (last visited apr. 6, 2014); stay calm and think smart, the keep calm-o-matic, http://www.keepcalm-o-matic.co.uk/p/staycalm-and-think-smart/ (last visited apr. 6, 2014), archived at http://perma.cc/hwg4-2urc. 157 see anette prehn & kjeld fredens, play your brain: adopt a musical mindset and change your life and career (2012). 158 see david perlmutter & alberto villoldo, power up your brain (2011). vol. 11:2512 can we trust consumers with their brains? things 159 and even outsmart the brain. 160 products reportedly developed by physicians, mental health providers, researchers, and others claim to calm the brain, 161 enhance mood, 162 improve focus, 163 improve thinking 164 and induce weight loss. 165 if the consumer conceptualizes the brain as lazy or out of shape, products are available to balance 66 and exercise the brain to feel better than ever, prevent decline and become smarter.167 159 see brain controllers, biotelemetrica, http://biotelemetrica. pbworks.com/w/page/1481 5 3 2 /braincontroller (last visited apr. 6, 2014), archived at http://perma.cc/wnh2-6bpn. 160 see outsmart your brain, http://outsmartyourbrain.com (last visited apr. 6, 2014), archivedathttp://perma.cc/lq3e-8xyh. 161 see brain calmers, mindworks, http://store.amenclinics.com/ supplements/gaba-calming-support (last visited nov. 9, 2013), archived at http://perma.cc/54bh-meh4. 162 see mood support, mindworks, http://store.amencinics.com/ supplements/mood-support/ (last visited apr. 6, 2014), archived at http://perma.cc/3297-s7ep. 163 see brain focus, mindworks, http://store.amencinics.com/ supplements/brain-focus/ (last visited apr. 6, 2014), archived at http://perma.cc/z54p-dm3s. 164 see total health network brain support, total health discount vitamins, http://www.totaldiscountvitamins.com/product/ 25957/totalhealth brands (last visited apr. 6, 2014), archived at http://perma.cc/r5lk-pe9x; cerebrate, 4 organics, http://organicsmanufacturer.com/memory-booster-brain-health.php (last visited apr. 6, 2014), archived at http://perma.cc/lde9-du9h. 165 see georgia d. andrianopoulos, retrain your brain, reshape your body: a breakthrough brain-changing weight-loss plan (2007); jennifer jolan & rich bryda, brain controlled weight loss: the solution to failed diets & exercise programs (2012). 166 see jay lombard et al., balance your brain, balance your life: 28 days to feeling better than you ever have (2003); how to balance your cortices, body talk space, http://bodytalkspace.wordpress.com/media/support/how-to-balance-yourcortices-your-brain/ (last visited apr. 6, 2014); restorative minds, http://www.restorativeminds.com (last visited apr. 6, 2014), archived at http://perma.cc/g4e7-v3jr. 167 see scott cram, train your brain and entertain, lybrary.com, http://www.lybrary.com/train-your-brain-and-entertain-p-379.html (last visited apr. 6, 2014), archived at http://perma.cc/5qm8-qk95; brain 2014 513 indiana health law review parents and care providers are told that they can also improve the brains of the next generation-children's brains.16s v. brain self-help consumers and consumer protection although brain themed products are common, not all brain themed products are brain self-help products. examples of brain themed products that would not be considered self-help products include technologies using a simplistic brain computer interface to guide figures in a video game or control a mobile device. similarly, using brainwaves for matchmaking would not be a brain self-help product. 169 though likely perceived of as more credible than they are to consumers owing to neuromyths, these products do not claim to alter brain function or improve the brain. the focus of this discussion is on technologies making brain improvement claims. examples include devices that encourage consumers to visualize brain waves and draw conclusions about mental states. brain exercising games propagate the brain-as-muscle neuromyth and make claims of improving memory, cognition, decision-making, and behavior due to alteration in brain function. these, along training, brain metrix, http://www.brainmetrix.com (last visited apr. 6, 2014), archived at http://perma.cc/w8p8-d6vy. 168 see michael scanlon, brain training for lds, lumosity blog (may 14, 2008), http://www.lumosity.com/blog/brain-training-for-kids/; fun brain training for children, mind sparke, http://www.mindsparke.com/funbrain-training-focusbooster.php (last visited apr. 6, 2014), archived at http://perma.ccllra5-x3a6; focus pocus, neuro sky (aug. 25, 2011), http://press.neurosky.com/pdfs/ focuspocus-factsheet.pdf, archived at http://perma.ccl942z-8xym. 169 see dating website examines brainwaves to find better matches, neurogadget.com (feb. 14, 2011), http://neurogadget.com/ 2011/02/14/dating-website-examines-brainwaves-to-find-bettermatches/296, archived at http://perma.cc/x2cg-z6n8; andreas bartels & semir zeki, the neural basis of romantic love, 11 neuroreport 3829 (2000); jeffrey c. cooper et al., dorsomedial prefrontal cortex mediates rapid evaluations predicting the outcome of romantic interactions, 32 j. neuroscience 15,647 (2012). vol. 11:2514 can we trust consumers with their brains? with seminars, books, foods, and supplements making similar claims, are considered brain self-help products in this discussion. consumer demand for brain self-help products is high and expected to continue to grow at record rates. 170 consumers generally believe that they have at least a relative safety net171 when shopping for products in the marketplace because of extensive consumer rights and protections that exist through regulation.' 72 the fda in 170 see kerry watson, cognitive health ingredients drive category growth, natural products insider (june 25, 2013), http://www. naturalproductsinsider.com/articles/2013/06/cognitive-health-ingredientsdrive-category-growt.aspx, archived at http://perma.cc/7ybb-eg7d; see generally tyson greer, the us consumer market for brain fitness applications: 2009-2014 forecast and analysis, ambient insight targeted research report (april 2010), http://ambientinsight.com/ resources/documents/ambientlnsight 2009 2014_usconsumerbrainfitn essexecoverview.pdf, archivedathttp://perma.ccnmj7-xjdl. 171 glenn kaplan, patching the holes in the consumer product safety net: using state unfair practice laws to make handguns and other consumer goods safer, 17 yale j. on reg. 2 (2000); see also, e.g, world's food standard body praised as safety net for consumers, food and agric. org. of the u.n. (july 2, 2013) http://www.fao.org/news/story/en/item/ 179340/icode/, archived at http://perma.cc/9ava-qjvt; solange helinvilles, a stronger safety net for european consumers, socialists & democrats (oct. 17, 2013), http://www.socialistsanddemocrats.eu/ newsroom/stronger-safety-net-european-consumers, archived at http://perma.cc/9b4s-qf4c; stephen koff, consumer safety net has payed, cleveland.com (apr. 6, 2008, 8:00 pm), http://blog.cleveland.com/ openers/2008/04/_washington_1asthalloween.html, archived at http://perma.cc/gzk2-fvd8; protecting, and mending, our consumer safety net, courant (nov. 4, 2007), http://articles.courant.com/2007-1104/business/071103 0 0 0 2 i1_publisher-of-consumer-reports-consumersunion-food-safety, archived at http://perma.cc/yfy9-tatt. 172 john f. kennedy, special message to the congress on protecting the consumer interest, the american presidency project (mar. 15, 1962), http://www.presidency.ucsb.edulws/?pid=9108, archived at http://perma.cc/x74c-h83x; see consumer rights, consumers int'l, http://www.consumersinternational.org/who-we-are/consumer-rights (last visited apr. 7, 2014), archived at http://perma.cc/c7r4-3evf; robin brown, the un guidelines for consumer protection: making them work in developing countries, in consumers in the information society: access, fairness and representation (2011); mary lush & val hinton, consumer bill ofrights, in encyclopedia of 2014 515 indiana health law review fact states as one of its goals "to build a public health safety net for consumers around the world."173 yet most, if not all, brain self-improvement products arrive on the market without particularly rigorous testing regarding claims made. repeated controversies such as cereals claiming cognitive enhancement,174 weeds found in herbal supplements, 75 and deaths following use of energy drinks marketed to the young are but a few examples of how this proverbial safety net fails to meet consumer expectations of protection. 176 the reality is that the individual consumer is responsible for discovering and weighing risks and benefits associated with the use of the products because investigations occur after reports of dissatisfaction or adverse events. though there have been repeated attempts by producers and marketers to cast biological information and business and finance (burton s. kaliski eds., 2d ed. 2007); u.n. comm'n on sustainable dev., consumer protection and sustainable consumption: new guidelines for the global consumer (1998). 173 global initiative, u.s. food and drug administration, http://www.fda.gov/aboutfda/globallnitiative/ (last updated dec. 18, 2013), archived at http://perma.cc/edp7-5npv. 174 kellog settles ftc charges that ad's for frosted miniwheats were false, fed. trade comm'n (apr. 20, 2009), http://www.ftc.gov/news-events/press-releases/2009/04/kellogg-settles-ftccharges-ads-frosted-mini-wheats-were-false, archived at http://perma.cc/bys7-w32p. 175 mary beth quirk, testing reveals weeds and rice fillers where the herbs should be in herbal supplements, the consumerist (nov. 4, 2013), http://consumerist.com/20l3/11/04/testing-reveals-weedsand-rice-filers-where-the-herbs-should-be-in-herbal-supplements, archived athttp://perma.ccla9-d7tt. 176 energy 'drinks" and supplements: investigations of adverse event reports, u.s. food and drug admin. (nov. 16, 2012), http://www.fda.gov/food/recallsoutbreaksemergencies/safetyalertsadv isories/ucm328536.htm, archived at http://perma.cc/tc2x-wctt; letter from edward markey, u.s. senator, john d. rockefeller, u.s. senator, richard j. durbin, u.s. senator, and richard blumenthal, u.s. senator, to scott henderson, president living essentials (sept 25, 2013) available at http://www.markey.senate.gov/documents/2013-0925_5hr.pdf, archived at http://perma.cc/jrt7-qb7e. vol. 11:2516 can we trust consumers with their brains? manipulation of the brain as entertainment, 177 the promise of changing or improving the physical brain is at the heart of most advertised benefits in brain self-improvement. looking for health information is in fact a common online activity. eight in ten internet users have looked online for health information, 178 and there are health claims contained in the advertising of many neuro self-help products. a recent google search of "brain health" returned 930,000,000 results in 0.26 seconds. the search screen featured more than eleven advertisements for brain training games and supplements on the banner and side bar, with only a few mentions of information from noncommercial entities. one game specifically states that individuals with attention deficit hyperactivity disorder benefit from using this game, loosely based on eeg 177 see generally imran khan, spit parties: genetic testing becomes a social activity, the guardian (sept. 18, 2008, 6:52 am), http://www.theguardian.com/science/blog/2008/sep/18/genetic.testing, archived at http://perma.cc/6pne-q9vg; party till you spit, the 23 and me blog (dec. 4, 2007), http://blog.23andme.com/news/inside23andme/party-till-you-spit/, archived at http://perma.cc/7neh-9hu9; jess zielinski, 'spit parties'. you want a genetic test with your cocktail., usa today (sept. 16, 2008, 11:27 am), http://content. usatoday.com/communities/sciencefair/post/2008/09/779570/1#.updvdau 4tlp, archived at http://perma.cc/ej5y-lxkd; steven novella, brain stimulation for the masses, science-based medicine (july 10, 2013), http://www.sciencebasedmedicine.org/brain-stimulation-for-the-masses/, archived at http://perma.cc/uz2t-kd4q; einstein brain trainer, bbg entertainment, http://www.bbg-entertainment.com/games/einsteinbrain-trainer (last visited apr. 7, 2014), archived at http://perma.cc/6t5l-netq; goflow, http://flowstateengaged.com (last visited apr. 7, 2014); christopher mims, diylit overclocks your brain with direct current, mit tech. review (mar. 8, 2012), http://www.technologyreview.com/view/427177/ diy-kit-overclocks-yourbrain-with-direct-current/, archived at http://perma.cc/zp2a-e5cp. 178 susannah fox, health topics' 80% of internet users look for health information online, pew research ctr. (feb. 1, 2011), available at http://www.pewinternet.org/-/media//files/reports/2011/ piphealthtopics.pdf, archived at http://perma.cc/98kp-vkmh; see generally susannah fox & maeve duggan, health online 2013, pew research ctr. (jan. 15, 2013), available at http://www.pewinternet.org/ -/media//files/reports/piphealthonline.pdf, archived at http://perma. cc/h6r9-fznk. 2014 517 indiana health law review technology.179 this tie between implied health information and brain products allegedly "not designed or intended to diagnose or treat health problems" is not subtle. when looking at credible sources of consumer friendly brain information, the dana foundation brain health information did not appear until the third search screen, the first result referencing the national institutes of health was on the fifth page of search results, and the first centers for disease control reference was on the seventh page of search results. the vast majority of the initial 100 search results were for various commercial brain self-help products. a. why protect the brain self-help consumer? to the degree that the rational consumer has a selfidentified need that an available technology can meet, understands the technology and its risks, has access to the technology, is prepared for the associated outcomes and has the resources to buy the product, a consumer rights model would suggest that he or she should be able to do so with the comfort that marketplace regulation will provide fair competition and the free flow of truthful information in the marketplace.1 80 behavioral economics suggests that consumers are however not always rational actors.1 81 consumers may be vulnerable as the result of temporary or permanent individual life circumstances such as youth, illness, infirmity, and illiteracy.182 as previously noted, people in distress and those with mental illness were more likely to seek alternative therapies, and thus there are particular areas of concern around brain self-help. market factors 179 focus pocus, neuro sky (aug. 25, 2011), http://press.neurosky.com/pdfs/focuspocus-factsheet.pdf, archived at http://perma.cc/6m4q-nlw3. 180 see consumer rights, supra note 172. 181 cass r. sunstein & richard h. thaler, nudge (2009); peter a. ubel, free market madness: why human nature is at odds with economics-and why it matters (2009). 182 eccg plenary, european consumer consultative group opinion on consumers and viability (2013). 518 vol. 11:2 can we trust consumers with their brains? such as information asymmetry, supplier exploitation, and complex products may contribute to consumer vulnerability, as can limitations in environments and alternative products and services. 183 social factors such as exclusion and isolation may also increase consumer vulnerability. 18 4 even consumers who might not otherwise be considered vulnerable respond to group pressure, suggestion, and faulty cause and effect associations seen in many advertisements. although there is a strong desire for science and health news, both scientific and health literacy have been identified as major challenges facing u.s. consumers. 185 trust appears to play at least as prominent a role as factual knowledge in public understanding and acceptance of novel technologies. 186 studies have also indicated that consumers were easily misled by neuroscience jargon, elaborate brain pictures, and reductionistic explanations. 187 consumers also tend to approve of perceived medical uses of neuroscientific technologies 188 and may be relatively less critical when products appear to be health products. further, consumers tend toward products that promise them "real" change with a minimum of effort and 183 id. 184 id. 185 see generally satel & lilienfeld, supra note 49; hartz & chappell, supra note 43; donald kennedy & geneva overholser, science and the media, am. acad. of arts & scl. 27-28, http://amacad.org/pdfs/sciencemedia.pdf, archived at http://perma.cc/779a-pjxm; mark kutner et al., the health literacy of america's adults: results from the 2003 national assessment of adult literacy, nat'l center for educ. stat. (2006); the brain and the public: q&a with susan g. amara, president, the society for neuroscience, the kavli found., http://www.kavlifoundation.org/science-spotlights/sfn-amara-int (last visited apr. 7, 2014), archived at http://perma.cc/8bq7-w9yd. 18 zubin master & david b. resnik, hype and public trust in science, 19 sci. & engineering ethics 321 (2013). 187 tulpesh patel, article for argument: don't believe the neurohype, scicommbobulate (mar. 6, 2013, 7:54 pm), http://scicommbobulate.blogspot.com/2013/03/article-for-argument-dontbelieve-neuro.html, archived at http://perma.cc/acc6-6p9k. 188 see generally wardlaw et al., supra note 42, at 3. 2014 519 indiana health law review commitment. the vulnerability of the consumer to this convenience factor is well known to marketers.18 9 in the age of neuromania, or neurohype, misinformation about brain science comes from news reporting, entertainment, testimonials, and blogs in addition to product placements and advertisements. while not unique to neuroscience, false positive study results abound, and little explication of study design and limitations is seen in the popular media. 190 thus, the reliable information available to even the savviest of consumers is limited. in general, consumers tend to be overly confident and overly optimistic. 191 just as trust plays a significant role in the understanding and acceptance of biotechnology, so it does in product acceptance. consumers are frequently unaware of the degree to which there is purposeful exploitation of their biases. 192 for instance, there is a strong tendency for people to accept things when told that many other people accept them, so advertisers may well use language to suggest that product use or benefit is occurring in large groups of people. people also tend to identify with other people like them in some ways so testimonials may be used to facilitate this identification. 193 there are also 189 see, e.g., w. thomas anderson, jr., identifying the convenience-oriented consumer, 8 j. marketing res. 179, 179-83 (1971); lew g. brown, the strategic and tactical implications of convenience in consumer product marketing, 6 j. consumer marketing 13, 16-18 (1989); eugene j. kelley, the importance of convenience in consumer purchasing, 23 j. marketing 32, 32 (1958). 190 john p. a. ioannidis, an epidemic of false claims: competition and conflicts of interest distort too many medical findings, scl. am. (may 17, 2011), http://www.scientificamerican.comlarticle.cfm?id=anepidemic-of-false-claims, archived at http://perma.ccur3v-5nec; wardlaw et al., supra note 42, at 1. 191 sunstein & thaler, supra note 181, at 31-33. 192 see generally sunstein & thaler, supra note 181; see generally ubel, supra note 181. 193 see generally lumosity human cognition project, http://www.lumosity.com/ (last visited mar. 19, 2014) , archived at http://www.lumosity.com/ (claiming to have 50 million members from over 182 countries, and picturing people of diverse characteristics with the claim: "our members are amazing athletes, talented artists, and 520 vol. 11:2 can we trust consumers with their brains? tendencies to draw similarities between imagined and actual experiences, particularly those events occurring proximate in time, so advertising language is frequently broad and descriptive of common events. as brain images and scientific language become increasingly prevalent in news and entertainment, commercial vendors may borrow this language to engender trust and familiarity. consumers frequently assume that knowledge gained from the news media, combined with marketplace assurances of product safety and provision of sound information, provide a basis on which to make brain selfhelp product decisions. 194 not unsurprisingly, studies confirm that media reporting "moderates differences between the public and experts" regarding appropriate uses of brain technologies. 195 there are also no easily identifiable major aggregators of consumer feedback regarding brain self-improvement products or of balanced research findings related to these products to assist the consumer who might search for information about them. consumers do not tend to reason that any and all interactions with the environment change blood flow and brain activity on a continuous basis, so claims about a product changing the brain do not appear as obviously flawed, or even comical, to the casual consumer as they frequently do to practitioners and scientists. although neuroscience is in its infancy, and there is significant scientific indeterminacy in many areas, there are frankly preposterous claims196 that should be readily identifiable as such by regulatory bodies and the truly empowered consumer. hard-working parents. but no matter where they come from, they can challenge their brains with lumosity."). 194 see generally paul d. nussbaum, brain health: bridging neuroscience to consumer application, 35 generations j. am. soc'y on aging 6 (2011). 195 o'connell et al., supra note 37, at 634. 196 see molly crockett, beware neuro-bunk, tedsalon (nov. 2012), http://www.ted.com/talks/ molly-crockettbewareneurobunk.html?quote=1991. 2014 521 indiana health law review at its best, marketing has the goal of matching safe and effective products with the consumer seeking them. however, manipulative advertising and disease mongering are also real phenomena. 197 consumers may be influenced by suggestions of a starting point for their thoughts about a matter, capitalizing on or pathologizing common occurrences, framing effects, appeals to loss aversion, and pointing to similar (even if infrequent) situations.198 for example, consumers may be influenced to believe that they have a need based on advertisements that define common normal variations in function as indications of disease or equate risk factors and disease states. 199 the advertisements then typically ascribe negative emotion or suffering to this state of less than optimal functioning. manipulative advertisers may also misuse statistics to exaggerate frequency of the need. 200 the advertisements then go on to idealize product effects, set vague endpoints for product use, and tell the consumer that he or she will function at a higher level if this need (dysfunction, difficulty, or disease) is corrected. this type of manipulative advertising is sometimes referred to as disease mongering. 201 manipulative advertising underestimates 197 see ray moynihan & david henry, the fight against disease mongering: generating knowledge for action, 3 plos med. e191 (2006), http://www.plosmedicine.org/article/fetchobject.action?uri=info%3adoi% 2f10.1371%2fjournal.pmed.0030191&representation=pdf, archived at http://perma.cc/76hm-mw4j; barbara mintzes, disease mongering in drug promotion: do governments have a regulatory role? 3 plos med. e198 (2006), http://www.plosmedicine.org/article/ fetchobject.action?uri=info%3adoi%2f10. 1371%2fjournal.pmed.003019 8&representation=pdf, archived at http://perma.cclm2mq-7r8m. 198 see generally daniel kahneman, thinking, fast and slow (2013); sunstein & thaler, supra note 181; ubel, supra note 181. 199 ray moynihan et al., selling sickness: the pharmaceutical industry and disease mongering, 324 bmj 886 (2002). 200 id. 201 see generally kalman applbaum, pharmaceutical marketing and the invention of the medical consumer, 3 plos med. e189 (2006), http://www.plosmedicine.org/article/fetchobject.action?uri=info%3adoi% 2f10.1371%2fjournal.pmed.0030189&representation=pdf, archived at http://perma.cc/zgb7-y48m; moynihan & henry, supra note 197. vol. 11:2522 can we trust consumers with their brains? risk of the proposed product, overestimates value to the individual, changes how consumers frame their problems, and shifts how they see the range of potential answers. 202 pointing out to the consumer what has happened and providing alternative sources of information are successful ways of responding to these common areas of misperception and can improve decision making substantially. 20 3 the risks to consumers posed by these products range from obvious physical injury by ingesting novel substances or applying electrical current to the brain, to the more subtle loss of opportunity harms (i.e. diversion of time and resources from activities that are more likely to be beneficial to the consumer). although the weighing of cost and benefit and safety and efficacy belongs to the consumer using these self-improvement products, when claims of brain manipulation are made, there are additional concerns about efficacy and reliability of the information and product. b. examples of information offered to consumers in the section that follows, brain self-help technology websites were reviewed and quotations have been excerpted to demonstrate the information that consumers are often faced with when searching for and making decisions about brain self-help products. a popular website 204 lists many untested or unproven self-improvement modalities for brain health and cognitive enhancement clothed in the language of health and science, including books and tapes, supplements, cranial electrical stimulation ("ces") devices, light and sound machines, home eeg and biofeedback devices, and colloidal silver generators that will enable the consumer to "take control of 202 see jon d. hanson & douglas a. kysar, taking behavioralism seriously: some evidence of market manipulation, 112 harv. l. rev. 1420 (2008); see generally ubel, supra note 181. 203 annie y.s. lau & enrico w. coiera, can cognitive biases during consumer health information searches be reduced to improve decision making? 16 j. am. med. informatics ass'n 54 (2009, see also sunstein & thaler, supra note 181. 204 elixa peak being, http://elixa.com (last visited apr. 7, 2014). 2014 523 indiana health law review your physical and mental health."205 the website material reflected an overt attempt to facilitate consumer trust in the products by attempting to ground them in science, indicating that the company "has evolved as the result of over 30 years of research." the supplier further claimed that products were "personally tested and researched" 206 implying both safety and efficacy. and most directly the advertising suggested that the consumer "will find products that go beyond simple maintenance and quick 'cures,"' 207 implying a categorical separation between the listed products and all others. under the cranial electrical stimulation category, the website proclaims, "stress is our nation's #1 health problem. it is the source of the anxiety, depression, and insomnia plaguing millions of americans. stress accounts for more than two-thirds of family doctor visits and is an important risk factor in all major illnesses. left unchecked, it is a killer." 208 these are examples of enhancing frequency statistics, pathologizing common and poorly described mental states, and catastrophizing a lack of attention to the identified common severe impairment. although the disclaimer language later indicates that these are not health claims, the remainder of messages on the website clearly surround brain manipulation. unlike the product marketing language expressed in plain language, placed in the center of the page and in large attractive font, the terms of use are located in a rather inconspicuous place on the website and are introduced as follows: "please read the legalese about the limits of our liability and your responsibility for using experimental healing modalities." 2 09 the term legalese is defined by miriam webster dictionary as "the language used by lawyers that is difficult for most people to understand" and 205 id. 206 id. 207 id. 208 id. 209 id. vol. 11:2524 can we trust consumers with their brains? "specialized language of the legal profession."210 the very use of this word seems to indicate that the advertiser specifically made the information obtuse. this designation of the language as difficult or foreign to the consumer tends to separate the consumer from the very systems seeking to protect him or her and is in distinct contrast to the consumer-friendly language about the product. the placement and use of language both appear to be obvious attempts to dissuade the consumer from reading and considering the material. this is an example of a framing effect. the disclosures then explicitly paint the product information offered as educational and recreational, the information provided by elixa.com is for educational and entertainment purposes only and should not be interpreted as a recommendation for a specific treatment plan, product, or course of action. elixa.com does not provide specific medical advice, and is not engaged in providing medical or professional services. use of elixa.com does not replace medical consultations with a qualified health or medical professional to meet the health and medical needs of yourself or a loved one. 211 the concept that this is education and entertainment should be rejected out of hand as patently disingenuous given the remainder of the material contained in the website. examples of specific health claims include "cranial electrical stimulation for mood, iq, addictions."212 specifically, the ces ultra advertisings indicated that it 210 legalese definition, merriam-webster, http://www.merriamwebster.com/dictionaryllegalese (last visited apr. 7, 2014), archived at http://perma.cc/6wqc-8l22. 211 terms of use, elixa peak being, http://elixa.com/terms.htm (last visited apr. 7, 2014), archived at http://perma.cc/ch4z-dw73. 212 mind machines, elixa peak being, http://www.elixa.com/mental/mental.htm (last visited apr. 16, 2014), archived at http://perma.cc/at3y-rysl. 2014 525 indiana health law review would enhance cognition and memory, elevate mood, and stabilize sleep. the mind machine is a bit more suggestive, orienting the consumer with the statement, "our mind machines will make you smarter, more productive, happier, relaxed, and 'in the zone."' 213 the website then offers this quotation from a book that demonstrates suggestion, framing, promise of biological change, subjective criteria for measuring improvement, and reference to increasing numbers of people using the technology: you sit down comfortably, don the electrical headgear, flip a switch, close your eyes and sink into a state of what seems like deep relaxation. a half hour later, as you turn off the machine, you feel extremely alert and lucid. your brain is now functioning more effectively than it was before. your memory -both your ability to memorize new information and to recall information you have already learned -has increased dramatically. your ability to think creatively, to solve problems, has expanded. the speed with which your brain cells pass messages among themselves has increased. in fact, many of your brain cells have actually grown a microscopic examination would show that the brain cells have developed more dendrites, the branching filaments that carry messages from one cell to another, and more synapses, the junctures between the brain cells across which impulses are transmitted. you are more intelligent than you were a half hour before. such devices now exist and are being used by increasing numbers of people.214 213 products and protocols for peak performance, elixa peak being, http://www.elixa.com/index.html (last visited apr. 16, 2014), archived at http://perma.cc/s2xt-rts4. 214 id. vol. 11:2526 can we trust consumers with their brains? the terms of service go on to explain that the website management "does not and cannot review all communications posted to elixa.com,"215 explaining that it contains links for the convenience of the reader without any implication of endorsement, operation, or control of the third party business. although the website touts the health benefits of products, it does not contain warning letters or critiques of its products, including the ingestion of colloidal silver allegedly made from generators. 216 in fact, it goes so far as to say why argyria (skin turning blue due to silver ingestion) will not occur. 217 other undisclosed harms of silver ingestion include kidney damage and neurological problems such as seizures. the fda published position excerpted below is unlikely to come to the attention of the average consumer using this website as it is absent from the product website and not prominent in any consumer forum: silver is present in the environment, and therefore people are normally exposed to it. however, silver is a nonessential mineral that has no known physiological functions or benefits when taken orally. silver has some appropriate medical uses, such as medicines, bandages, and dressings used to treat burns, skin wounds, or skin infections, and as medicines used to prevent the eye condition called conjunctivitis in newborn infants. however, there are no legally marketed prescription or over-the215 id. 216 see, e.g., consumer advisory: dietary supplements containing silver may cause permanent discoloration of skin and mucous membranes (argyria), u.s. food and drug administration (oct. 6, 2009), http://www.fda.gov/food/recallsoutbreaksemergencies/ safetyalertsadvisories/ucml84087.htm, archived at http://perma.cc/ a9xb-hqxw. 217 make your own colloidal silver, the antibiotic of the future. elixa peak being, http://www.elixa.com/silver/index.htm (last visited apr. 8, 2014), archived at http://perma.cc/hf5d-2ppk. 2014 527 indiana health law review counter (otc) drugs containing silver that are taken by mouth. fda regulates dietary supplements under a different set of standards than those that apply to drugs. for example, fda does not approve dietary supplements or their labels before they are sold. it is unlawful for a manufacturer to represent a dietary supplement containing silver as able to prevent, diagnose, mitigate, treat, or cure any disease.218 in this example, the alleged health benefits were described over many pages, disclosures were not present, and adverse effects were not mentioned anywhere. regardless of the status of product purveyors as health providers, the disclosure of risk in the face of claimed benefit is a responsibility the marketer bears with regard to the consumer. in addition to disingenuous and incomplete content, negative framing language, and inconspicuous placement, these disclosures are also frequently presented to consumers in ways that make them unlikely to be noticed or read by the consumer. the disclosure in figure 1 features small font, poor resolution, inconspicuous location, and a message that is inconsistent with the rest of the site. these qualities make the information less likely to be viewed by the consumer. 219 again, the disclaimer says that the suppliers are not health practitioners and information comes from a variety of sources, this website describes doing things to the body to 218 consumer advisory, supra note 214; see also over-the-counter drug products containing colloidal silver ingredients or silver salts, 64 fed. reg. 44,653, 44654 (aug. 17, 1999). 219 see generally, e.g., dan j. graham & robert w. jeffery, location, location, location: eye-tracking evidence that consumers preferentially positioned nutrition information, 111 j. am. dietetic ass'n 1704 (2011). vol. 11:2528 can we trust consumers with their brains? achieve a health outcome (i.e. putting electrodes on the wrists to cleanse the blood from viruses and toxins, magnetizing lymphatics, and drinking colloidal silver and freshly ozonated water to optimize benefits received from the brain (now called bio) tuner and light therapy).220 figure 1. 3iscaimer: we are not halth practitioners. by readig the information on this site you are agreeing that you take full respf blity for any decision you make bcase of it. any inaration shared is ased onr sience, hearsay, tes a, la y ea ndproessional h i content provided on this site is for iformationa rposes oaty and is not intended to diagn"s 5 treat or cure any medical co ition.lease coislt you ,eakth practtinr. qesut are not typical, a canadian retailer of a device goes on to add a disclaimer specific to the sale of the device (see figure 2).221 this particular disclosure goes on to define the site of the transaction as in canada, presumably an additional strategy to avoid potential action by u.s. regulatory authorities. figure 2. another website goes on to say that addiction, insomnia, and anhedonia are the result of brain problems that the bio tuner corrects. 222 alleged brain stimulators and colloidal silver generators are not alone in this parsing of the line between education, recreation and health care. the following "information" is provided to consumers to assist them in understanding light therapy. 220 what is the bece protocol, sharing health, http://www.sharinghealth.com/bob-beck-protocol.html (last visited apr. 8, 2014), archived at http://perma.ccldkx8-2ql7. 221 our products, sota, http://www.sota.com/sota-products.html (last visited apr. 8, 2014), archivedathttp://perma.cc/47ns-p8a8. 222 balancing the brain, sharing health, http://www.sharinghealth.com/bob-beck-brain-tuner.html (last visited apr. 8, 2014), archived at http://perma.cc/b9tw-eedx. 2014 529 indiana health law review mode e, 4,672 hz nerves used for spinal and skin disorders. resonates with the spinal cord and peripheral nervous system. also considered helpful for pain control.... mode f, 73 hz emotional reactions resonates with the subcortical or lower regions of the brain. includes the thalamus and hypothalamus-two major control centers for body functions. may also help with muscle spasms, facial pain, headaches and depression. has been used for non-healing bone fractures. may also help to balance hormones. mode g, 146 hz intellectual organization used for memory and psychological disorders. resonates with the cerebral cortex of the brain-involved with thinking, imagining and creating. may help with nervousness and worry.223 another brain self-help website has a more extensive, but no more informative, disclaimer. in the example below, the author of the disclaimer acknowledges that experts might disagree, disavows responsibility for the informational content of the site, rejects the implication of warranty and directs the reader to a provider. yet, none of the products on the website require a prescription from the consumer's local healthcare provider. altered states products are sold for learning, self-improvement and simple relaxation. no statement contained in this catalogue, and no information provided by any altered states employee, should be construed as a claim or 223 light therapy, sharing health, http://www.sharinghealth.com/led-light-therapy.html (last visited apr. 8, 2014) (emphasis added), archived at http://perma.cclct46-4aux. vol. 11:2530 2014 can we trust consumers with their brains? representation that these products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or any other medical condition. the information contained in this catalogue is deemed to be based on reliable and authoritative report. however, certain persons considered experts may disagree with one or more of the statements contained here. altered states assumes no liability or risk involved in the use of the products described here. we make no warranty, expressed or implied, other than that the material conforms to applicable standard specifications. the publisher does not accept any responsibility for the accuracy of the information or the consequences arising from the application, use, or misuse of any of the information contained herein, including any injury and/or damage to any person or property as a matter of product liability, negligence, or otherwise. no warranty, expressed or implied, is made in regard to the contents of this material. no claims or endorsements are made for any drugs or compounds currently marketed or in investigative use. this material is not intended as a guide to self-medication. the reader is advised to discuss the information provided here with a doctor, pharmacist, nurse, or other authorized healthcare practitioner and to check product information (including package inserts) regarding dosage, precautions, warnings, interactions, and contraindications before administering any 531 indiana health law review drug, herb, radionics tool, or supplement discussed herein.224 the above disclaimer appeared in the context of more than eleven printed pages on the treatment of drug withdrawal, pain, depression, anxiety, and memory deficits on a website selling products ranging in price from approximately $30 to over $1000. while these product claims, when combined with the disclosures, may meet some minimal regulatory standard, they are not effective consumer information and do little to correct the informational asymmetry between the consumer, actual state of the science, and claims of the manufacturer or marketer. c. enhancing consumer literacy although product information, disclaimers, labels, and instructions are considered by many to be among the most important sources of consumer education, the reality is that this product information is often difficult to understand owing to the brevity of the information provided, lack of contextual data, complex names, and terms and large amount of distracting general information. these features may cause consumers to overlook this information. there are also varying rules and regulations that detail how much information needs to be provided so that the idea of complete disclosure is more myth than reality. in addition to product information provided directly to the individual consumer, consumer watch groups have a role to play in informing and empowering consumers by providing credible information and reviews. since trust is a prominent factor in both interpretation of the science and in product selection, third party consumer watch groups may have a strong role to play in improving knowledge and therefore more advantageous product selection by consumers. the national consumers league is a private 224 altered states, http://altered-state.com/index2.htm (last visited apr. 8, 2014), archived athttp://perma.cc/t87p-6ddk. 532 vol. 11:2 can we trust consumers with their brains? non-profit advocacy group with a consumer website,225 but it does not appear to list many brain self-improvement products in a searchable fashion. quackwatch.com, on the other hand, is a website that reviews products and claims in a more easily searchable fashion. it provides lists of reliable and unreliable sources of health information and is equally critical of private and governmental ventures that it considers suspect. quackwatch is an international collaboration of experts closely affiliated with the national council against health fraud.226 while there are a number of government consumer information sites such as those through the department of health and human services' 227 centers for disease control and prevention and the national health information center, 228 the information is not arranged in a way conducive to consumer access. regarding brain health and product information, consumer health and human services information and resources and the consumer information center are no better.229 similarly, the national institutes of health offer information sites and bibliographies that could potentially be of use to consumers but are difficult to navigate, often fail to speak to specific brands of products and point to references that are not accessible to the average consumer. consequently, some of 225 national consumers league, http://www.nclnet.org (last visited apr. 8, 2014), archived at http://perma.cc/66ag-8qe5. 226 quackwatch, http://www.quackwatch.org (last updated mar. 23, 2014), archived at http://perma.cc/zc2z-n8qs. 227 healthfinder.gov, healthfinder.gov (last updated apr. 8, 2014), archived at http://perma.cc/5hy4-6cqh. 228 "the national health information center (nhic) is a health information referral service. nhic links people to organizations that provide reliable health information. nhic was established in 1979 by the office of disease prevention and health promotion (odphp), office of public health and science, office of the secretary, u.s. department of health and human services." national health information center, health.gov, http://www.health.gov/nhic/ (last updated apr. 8, 2014), archived at http://perma.cc/kt2c-7juz. 229 see generally publication.usa.gov, http://publications.usa.gov (last visited apr. 8, 2014), archived at http://perma.cc/pn2g-hxpp. 2014 533 indiana health law review the agencies likely to engender the highest levels of consumer trust also pass the highest information costs on to consumers by devising information sources that are not particularly user friendly. even when information is available, increasing scientific and health literacy will be one important step in helping the consumer become savvier regarding brain products. while compulsory public education is a good start, many advances will occur following the consumer's exit from formal education, and students frequently leave school without the skills necessary to understand these advances. at present, functional neuroimaging does allow researchers and clinicians to peer inside the skull and observe the living human's brain activity. however, the massive amounts of data produced are interpreted and reduced to pictures using complex statistical methods that are based on both a variety of assumptions and the nature of the research question asked. there is nothing simple or straightforward about experimental design, imaging modality or data interpretation in this field, and to suggest otherwise is, at best, foolhardy and, at worst, fraudulent. in building scientific literacy, scientific reporting will need to be more thorough and include disclosures when appropriate. in addition to identifying the limitations of the technology generally, there are study-specific issues of which consumers should be made aware including small sample size, uncontrolled multiple comparisons, overinterpretation of the data, findings of uncertain significance, and indications of premature or biased reporting. as consumers become aware of these factors it will become more difficult for commercial entities to leverage the brain image and the rhetorical brain construct to induce certainty about things in which there is none. as scientific literacy improves, individuals may also more accurately assess privacy concerns related to neuroimaging databases by being better able to differentiate valid versus vol. 11:2534 can we trust consumers with their brains? faulty inferences about internal mental states derived from brain images. 230 with improvements in consumer understanding of the technologies and studies and advances in the technologies themselves, communications to consumers via the media or regulation may begin to shift from a threshold kind of communication (i.e. whether a product could actually do what it purports) to more nuanced conceptualizations of risk-benefit and cost-value analyses. many information websites that might rightfully garner consumer trust are simply not user-friendly. they are not keyed to find the terms consumers search for, are difficult to navigate, and are frequently not engaging in their presentation. product placements in commercial websites are, in fact, engaging, accessible, and persuasive. while there are on-going attempts to make balanced consumer education more engaging, this work is in its relative infancy and only likely to be of benefit to future consumers. accepting that consumers consider most brain and brain product stories and advertisements to be health information at some level, is there a role for traditional healthcare systems in enhancing consumer literacy? most of the people who used the internet to search for health information also "got information, care, or support from a doctor or other healthcare professional," 231 indicating that there is an opportunity for the traditional health system to provide information about the brain and brain products to the consumer. some have pointed to the provider-patient relationship as "a reservoir of solutions to the challenges created by unproven interventions and translational research."232 yet, there is a move in healthcare to decrease reliance on routine health checks by physicians and other 230 see rachul & zarzeczny, supra note 99, at 77-81. 231 susannah fox & maeve duggan, pew research ctr., health online 2013 (2013), available at http://www.pewinternet.org/~/media// files/reports/piphealthonline.pdf, archived at http://perma.cc/ 4wwa-b38g. 232 eric racine et al., proven or unproven? panel report on ethics in the translation of neuroscience. 39 can. j. neurological sci. 247, 249 (2012). 2014 535 indiana health law review healthcare providers. both the annual wellness physical examination and the ordering of laboratory assessment in the asymptomatic patient have been found to lack cost effectiveness. 2 33 most healthcare providers will therefore be dealing with individuals who are already ill, not the rational well consumer seeking self-help. the involvement of physicians and other healthcare providers in the supervision or provision of alternative medicine technologies has been a topic of concern for individuals and healthcare entities, although historically recommendations or referrals for self-improvement activities, supplements and devices have not been a prominent source of practitioner liability exposure. 234 many brain self-improvement products are authored or endorsed by one or more entities with alleged expertise or authority (many advertising themselves as medical doctors, alternative practitioners or doctors of philosophy). physicians and other practitioners may also write blogs, offer advice online and write prescriptions for devices or medications purchased by patients online who may not wish to visit a terrestrial provider. liability issues related to these activities are unclear.235 as interactions between healthy adults and care professionals decrease, and professionals enter the world of general self-improvement outside interactions with 233 hanna e. bloomfield et al., va-esp project #09-009, evidence brief: role of the annual comprehensive physical examination in the asymptomatic adult (2011); stephanie thompson & marcello tonelli, general health checks in adults for reducing morbidity and mortality from disease, the cochrane library (oct. 9, 2012), http://www.thecochranelibrary.com/details/editorial/2723031/ general-health-checks-in-adults-for-reducing-morbidity-and-mortalityfrom-diseas.html, archived at http://perma.cc/58qf-5qxr. 234 see generally mark s. salzer & loran b. kundra, liability issues associated with referrals to self-help groups, 61 l. & psychiatry 6 (2010); c. lee ventola, current issues regarding complementary and alternative medicine (cam) in the united states, 35 p&t 570 (2010); joan gilmour et al., hospitals and complementary and alternative medicine: managing responsibilities, risk, and potential liability, 128 pediatrics s193 (supp. 2011). 235 see terry, supra note 30. vol. 11:2536 can we trust consumers with their brains? individual patients, it would seem that strong normative stands by professional organizations and clear communications to consumers about these technologies are necessary parts of a consumer-centric education effort. yet, no consumer-oriented statements by professional organizations in the area of neuro self-improvement could be located. with few exceptions, scientific groups and organizations have been relatively uninvolved in correcting public perception 236 and limiting commercial brain self-help technologies. some observers, in fact, blame both clinicians and scientists for shirking their responsibilities to the public by allowing their findings to be skewed in the popular media. a notable exception is an expert consensus panel that recommended consumers (1) look for products that can substantiate the claims made with independent verification, (2) separate items founded on plausible reasoning from those that have actually been tested, (3) not mistake improvement in a concrete task with global cognitive improvement, (4) consider that short-term improvement may not translate into long-term improvements, and (5) consider traditional activities that also result in cognitive improvement such as, for example, physical exercise, socializing with others, or learning a new life skill.2 3 7 though it is not popularized, this panel report is a promising attempt to provide direct actionable information to consumers. vi. mechanisms of consumer protection brain self-help products seem to have been able to have it both ways; that is, "inform" consumers that these are 236 wardlaw et al., supra note 42; sharon morein-zamir & barbara j. sahakian, neuroethics and public engagement training needed for neuroscientists, 4 trends cognitive sci. 49 (2010). 237 expert consensus statement on brain health, stan. ctr. on longevity, http://longevity3.stanford.edu/brain-healthlexpertconsensus-on-brain-health/ (last visited apr. 8, 2014), archived at http://perma.cc/5dh5-u28j. 2014 537 indiana health law review powerful products with the ability to change their brains yet escape the formal regulation accompanying traditional diagnostic and therapeutic modalities making similar claims. these products seem to put forth claims that they change physical brain activity without having to disclose that everything a person does changes brain activity and without any particular demonstration of concept. 238 sometimes these products are based on a shred of truth, or novel application of plausible biological principles, but at other times they seem based on neuromyth or sheer fantasy. the inability (or unwillingness) of commercial interests, consumer watch groups, and science watch groups to provide accessible information to consumers on which they could differentiate valid, potentially valid, and unlikely valid claims may be conceptualized as a market failure. as one observer noted, "when markets don't provide consumers with the information they need to make good decisions, the markets have failed, and policy makers need to take steps to make sure consumers get such information."239 if the use of these self-help products is considered a hobby or recreational pastime, then the risk disclosure alone would be adequate, and further use would presumably be driven by the pleasure derived from its use. although it would be convenient for industry to conceptualize that these technologies are recreational, available evidence suggests that brain self-help advertisements make health claims and consumers turn to these technologies for health-related concerns, so it is reasonable to conceptualize these health products falling under the fda and ftc regulatory authority. when costs and risks are relatively low, these products might seem harmless and mistakes in using them could be subsumed under a kind of consumer naivet6 that will 238 see generally kathleen taylor, the brain supremacy: notes from the frontiers of neuroscience (2012); tallis, supra note 3; should neuro-products be regulated like pharmaceuticals., neurobollocks (may 23, 2013), neurobollocks.wordpress.com/ category/brain-training, archived at http://perma.cc/6zum-vz7k. 239 ubel, supra note 181, at 14. vol. 11:2538 can we trust consumers with their brains? benefit from one trial of falling for an ineffective claim. however, this assumes a healthy, and well-informed, consumer acting on his or her own behalf, and that it is not uniformly the consumer that seeks and uses online health information such as that put forward in brain self-help. additionally, the advertisements tend to appeal to parents to use these products on their children and to individuals at risk for cognitive decline, so the well, young-adult consumer acting to fine tune his or her own body is only a portion of the market. brain-themed self-improvement materials such as books, recordings, games and apps would generally fall into the category of low-risk and-low cost endeavors that seem to attract a minimum of regulatory attention. when considering foods, supplements and devices for brain health and manipulation, public and private regulation becomes more complex with substantive regulation dealing with basic safety data and claims made. in situations in which physical risk remains relatively low, these more complex regulations provide a more minimal safety net than consumers assume and are perhaps no more useful to consumers than labels and disclaimers. a. self-regulation and soft law in an ideal world, self-regulation would rule the day.2 40 the arguments for self-regulation center around the idea that involvement in the enterprise is voluntary and that it is good business for producers to do adequate research before developing a product to make certain that it is effective, to produce a quality product, and then to stand behind that product, else risk losing market share. 241 240 see robert pitofsky, self regulation and antitrust, fed. trade comm'n (feb. 18, 1998), http://www.ftc.gov/news-events/pressreleases/1998/02/self-regulation-and-antitrust, archived at http://perma.cc/e97z-2h33; adam smith, wealth of nations, 1909-14 (c. j. bullock, ed., new york, p.f. collier & son 2001), available at www.bartleby.com/10/. 241 id. 2014 539 indiana health law review additionally, self-regulation is nimble and prompt in responding to problems experienced in the marketplace. 242 proponents will go on to argue that common law mechanisms exist for fraud and injury, and that those should be sufficient for consumer protection. voluntary self-regulation is pitched as cost-effective and good for everyone. 243 corporate codes of conduct and internal reviews are examples of self-regulation at the level of the single business. 244 an example of self-regulation in a larger corporate ecosystem is the advertising self-regulatory council administered by the council of better business bureaus. 245 in addition to internal self-regulation, companies may also voluntarily submit their products to private groups for review by agents external to the company. underwriters laboratories is one such company. it was established in 1894,246 to ensure safety of devices, but does not assess the validity of claims made by the device. for example, some consumer cranial electrical stimulation devices carry the following designation: "medical electrical equipment classified by underwriters laboratories inc.@ with respect to electric shock, fire, mechanical and other specified hazards only in accordance with ul-2601-1 and can/csa c22.2 no. 601.1. 34vf."2 47 the underwriters laboratories approval carries weight with consumers as a signal of overall product safety and quality despite the fact that this 242 id. 243 pamela jones harbour, fed. trade comm'r, helping the ftc help you: effective self-regulation is better business (2005). 244 see virginia haufler, a public role for the private sector 7-30 (2001). 245 see supporting advertising industry self-regulation, asrc, http://www.asrcreviews.org/supporting-advertising-industry-self-regulation/ (last visited apr. 8, 2014), archived at http://perma.ccyac-2lxn. 246 see generally underwriters labs., http://www.ul.com (last visited apr. 8, 2014), archived at http://perma.cc/38kq-8qd4. 247 owner's manual, alpha-stim scs (2002), http://biomedical.com/media/support/alpha-stim-scs-user-manual.pdf, archived at http://perma.cc/8z98-vnk3. 540 vol. 11:2 can we trust consumers with their brains? approval only pertains to physical risk and not to claims made. b. direct regulation informed and useful regulation must balance consumer desires for new information and products with product safety and reasonable controls on claims made. command and control regulation may have an advantage over selfregulation in including multiple points of view, not relying on volunteerism, and having the ability to impose sanctions and demand withdrawal of the product or the claim from the marketplace. 248 of course, opponents claim that command and control mechanisms risk slowing innovation, while proponents claim that these types of protections are essential for the protection of the public. while far from the only regulatory mechanisms applicable to brain self-improvement products, 249 the two command and control mechanisms that will be considered here are the ftc and fda. the ftc,250 via its bureau of consumer protection, is tasked with the prevention of fraud, deception, unfair business practices, and provision of free consumer information. 251 the ftc covers advertising of over the counter medications, foods and devices. section 45 of the federal trade commission act gives the ftc power to 248 pitofsky, supra note 240. 249 for example, state product safety legislation and policy are in place. glenn kaplan & chris b. smith, patching the holes in the consumer product safety net: using state unfair practices laws to make handguns and other consumer goods safer, 17 yale j. on reg. 253 (2000). 250 the ftc is comprised of seven divisions including advertising practices, consumer and business education, enforcement, financial practices, marketing practices, planning and information, and privacy and identity protection. about the bureau of consumer protection, fed. trade comm'n, http://www.ftc.gov/bcp/about.shtm (last visited apr. 8, 2014), archived at http://perma.cc/l7n-qyax. 251 see consumer information, fed. trade comm'n, http://www.consumer.ftc.gov (last visited apr. 8, 2014), archived at http://perma.cc/s8w9-xclk. 2014 541 indiana health law review investigate unfair and deceptive acts or practices including the omission of information material to a consumer's choice. 252 upon a finding of unfair or deceptive practices, the ftc may issue a cease and desist order and leverage penalties for violations, 253 such as when kellogg advertised that mini-wheats improve attention.254 the fda regulates the advertising of prescription drugs and restricted devices and handles misbranding and labeling issues.255 in drugs and restricted devices, products regulated are those products intended to diagnose, cure, prevent or treat disease or intended to affect the structure or function of the body. 256 where printed materials or websites make certain health claims, the fda may become involved, most commonly issuing warning letters.257 the fda also regulates health claims made by foods and supplements. a health claim occurs when there is a stated relationship between the food or supplement, or a component, and reduced risk of a disease or health condition. although the term "functional" is sometimes foods and dietary ingredients making health claims beyond general nutrition, the term has no legal definition and is not under a separate regulatory scheme. the fda, instead, regulates these products using the existing food regulatory scheme consisting of foods (conventional, modified or medical), food additives and dietary supplements, a system 252 15 u.s.c. § 45 (2014). 253 id. 254 press release, fed. trade comm'n, kellogg settles ftc charges that ads for frosted mini-wheats were false (apr. 20, 2009), available at http://www.ftc.gov/news-events/press-releases/2009/ 0 4 / kellogg-settles-ftc-charges-ads-frosted-mini-wheats-were-false, archived at http://perma.ccldk3p-k7l2. 255 what does fda regulate, u.s. food and drug administration, http://www.fda.gov/aboutfda/transparency/basics/ ucm194879.htm (last visited nov. 19, 2013), archived at http://perma.cc/7nwf-l67z. 256 21 u.s.c. § 321(g)-(h) (2014). 257 see generally inspections, compliance, enforcement, and criminal investigations, u.s. food and drug admin. (mar. 22, 2011), http://www.fda.gov/iceci/enforcementactions/warningletters/ 2 01 1/uc m250701.htm, archived at http://perma.cc/r92p-fgsq. vol. 11:2542 can we trust consumers with their brains? characterized by some as having arbitrary loopholes and inadequate enforcement strategies. 258 more highly regulated would be devices that monitor or effect change in human physiology. 259 devices such as home neurofeedback devices and "brain wave synchronizers" 260 might well fall under the jurisdiction of the fda. however, as a natural consequence of the brain's rock star status, brain self-help products have grown in prominence, and regulation around claims made by individuals not directly involved in manufacturing and supplying products are unclear.261 c ces devices: an example ofregulation and enforcement cranial electrotherapy stimulation ("ces") devices use low intensity electrical stimulation, usually delivered through ear clips or electrodes in the head and neck area, to treat anxiety, depression, and insomnia. the devices are classified as experimental. examining the challenge posed by these devices to regulatory systems may be instructive because it is an area in which the fda has made significant attempts to curb excessive claims and examine the risk benefit analysis.262 258 david kaplan, ethics and the life sciences, 32 j. phil. res. 177 (2007). 259 recently, the fda issued guidance on apps. see generally bradley merrill thompson, fda regulation of mobile health october (2013). this work provides an overview of fda regulation for innovators. 260 stephen barrett, questionable 'self-help" products, quackwatch, http://www.quackwatch.com/olquackeryrelatedtopics/ mentprod.html (last updated aug. 18, 2004), archived at http://perma.cc/q8tx-8vpe. 261 see kyle sampson & kayte spector-bagdady, administrative law & regulation: the regulation of prescription drug and restricted medical device advertising, 11 engage 4 (2010). 262 food & drug administration, petitions to request change in classification for cranial electrotherapy stimulators (2012), available at http://www.fda.gov/downloads/advisorycommittees/ committeesmeetingmaterials/medicaldevices/medicaldevicesadvisoryco 2014 543 indiana health law review though this kind of therapy likely has its origins in studies conducted in the eighteenth century, efficacy has yet to be established in adequately powered controlled clinical trials. this example is particularly relevant because many observers predict that the next wave of treatments for biobehavioral disorders will be in the area of neuromodulation, and, thus, the consumer will be faced with hearing about the likely successes of clinical neuromodulation and having to figure out whether consumer level devices are sufficiently similar to clinically available ones to be of use or are sufficiently different and to be avoided. in the late 1970s, the fda placed these devices in class iii owing to the lack of convincing data demonstrating benefit. the placement in class iii triggers the fda's most stringent application process for premarket approval ("pma") of devices. in 1997, the plia requirement was revoked, and the fda considered a move to class i or ii, inviting device manufacturers to submit evidence of safety and efficacy. in 2009, the fda obtained additional information from manufacturers and in 2011 published a proposed rule to again require premarket approval for ces devices. in 2012, the fda's neurological devices panel met and came to the decision and concluded that class iii placement with a pma requirement was appropriate. during the time in which these devices could enter the market without pma, device suppliers entered the market making claims that devices were fda approved or cleared for the advertised purposes that usually extended well beyond the three indications for which the device had actually been cleared. one ces device manufacturer in particular has been vocal about fda action requiring premarket approval for claims made. it initially claimed that the product was fdaapproved for a number of indications. the labeling was then changed to indicate it was fda-regulated. when the fda reinstated the plvia requirement, the manufacturer mmittee/neurologicaldevicespanel/ucm290787.pdf, archived at http://perma.cclvj9r-b26t. vol. 11:2544 can we trust consumers with their brains? then went on the offensive claiming that the fda was stalling the process and depriving consumers of technologies that the government itself is using.2 63 epi's largest customer is currently the united states government, and preventing the marketing of alpha-stim@ would deprive our soldiers and veterans of an effective tool in their battle against insomnia, anxiety, depression and ptsd. ironically, while one branch of government (fda) is attempting to justify spending millions of dollars to prevent the marketing of ces, other branches (the dod and va) are spending millions of dollars purchasing alpha-stim@ ces and on research to study the effects of alpha-stim@ ces on our soldiers and veterans. 264 the document ends with a call to action "epi is asking that you simply tell fda the truth about how safe and effective ces is for you and/or your patients. epi will deal directly with the issues in the proposed rule."2 65 epi also refers to itself as the most regulated company in the united states and has links to alleged improper behavior by the fda. in the midst of these machinations, it is not at all clear that consumers understand the differences between terms like fda-approved, -cleared, -regulated, and -allowed, so the supplier of the technology is able to sustain the appearance of governmental testing of efficacy when, in fact, the product may be regulated due to a lack of efficacy 263 see generally alpha-stim, petitioner presentation to neurological devices panel for reclassification of alpha-stim@ ces devices from class iii to class ii (2012), available at http://www.alpha-stim.com/wp-content/uploads/epis-fda-presentation.pdf, archived at http://perma.cc/rp7z-m5my. 264 alpha-stim, epi fact sheet, available at http://www.alphastim.com/wp-content/uploads/epi-fact-sheet.pdf, archived at http://perma.cc/7h37-ns7w. 265 id. 2014 545 indiana health law review combined with an unacceptable risk of side effect. 266 while technically true, this is misleading: "ces in the united states has received food and drug administration marketing clearance for the treatment of anxiety, depression, and insomnia. ces devices are sold over the counter in europe and other parts of the world."2 67 again, this is an example of appealing to potential consumer biases by framing the technology as safe and effective and suggesting that the rest of the world uses it without government interference. it is not difficult to conceptualize potentially informative text about these issues. consider these two examples: "fda believes that the available scientific evidence supports a class iii determination because the data do not support a reasonable assurance of safety and effectiveness, the proposed special controls would be insufficient to provide such assurance, and there is an unreasonable risk of illness or injury,"268 or, even more simply phrased, "the suppliers of this device have not demonstrated effectiveness and safety so the fda does not recommend, approve, or condone its use for any purpose." the fda has, in fact, made attempts to limit the claims made by alpha-stim, health directions, and others. 269 266 see patti zettler, "electroceutical" ads are here. what will regulators say, ctr. for law. biosciences, stanford law sch. (oct. 24, 2013), http://blogs.law.stanford.edulawandbiosciences/ 2 013/10/24/ electroceuticalads-are-here-what-will-regulatorssay/, archived at http://perma.cc/uax9-nurc. 267 alpha theta stim, altered states, http://alteredstates.net/barry/newsletter203/alphathetastim.htm (last visited apr. 8, 2014), archived at http://perma.cc/429u-s43g. 268 epi fact sheet, supra note 264. 269 see, e.g., warning letter from thomas d. gardine, district director, philadelphia district, u.s. food and drug admin., to harold d. stecker, president, health directions, inc. (mar. 4, 2004) [hereinafter warning letter to harold d. stecker], available at http://www.fda.gov/iceci/enforcementactions/warningletters/ 2 0 0 4 /ucml4 6243.htm, archived at http://perma.cc/dv8p-jv7h; warning letter from reynaldo r. rodriguez, jr., dallas district director, u.s. food and drug admin., to daniel l. kirsch, chairman, electromedical products int'l, inc. (apr. 30, 2013) [hereinafter warning letter to daniel l. vol. 11:2546 can we trust consumers with their brains? however, on the most recent visit to the alpha-stim website this statement appeared: "alpha-stim is fda approved and can only be purchased with a prescription. to discuss your alpha-stim needs with dr. james g. friesen please call (818) 893-4463 and leave him a message."270 this clinical psychologist goes on to say, "should you consider purchasing one, you will be pleased to know that alphastim is fda approved and that no significant side effects have been reported in over two decades of use. the price is $795, and that includes a five-year warranty."271 he then says, i believe it is unethical for therapists not to try using alpha-stim. here is the point: if therapists know that something may help their patients and yet they refuse to try it, that is unethical. these are not simply "initial findings" we have over [fifty] scientific studies that support these clinical observations. after continuing treatment with about [one hundred] people in therapy for over three years, i believe that my initial findings are supported by what my patients continue to report. therapists are mandated to continue to learn about interventions that can help their patients, so if alpha-stim may help, therapists cannot afford to ignore that.272 the above text section also demonstrates the additional problems of professionals offering testimonials and making claims without apparent concern for action by regulatory authorities. by having an appointed practitioner offer kirsch], available at http://www.fda.gov/iceci/enforcementactions/ warningletters/2013/ucm351179.htm, archived at http://perma.cc/ ah5z-kj4q. 270 an introduction to the alpha-stim stress control system, jamesgfrieson.com, http://www.jamesgfriesen.comlalpha-stim.shtml (last visited apr. 8, 2014), archived at http://perma.cclv22e-eg8h. 271 id. 272 id. 2014 547 indiana health law review professional opinions and provide prescriptions, these companies work around any opportunity for consultative involvement by traditional healthcare outlets that could provide balanced and personalized information to the consumer. while it might be reassuring from a physical safety perspective that the product price is clearly advertised, that it comes with a warranty and that it is not considered a shock risk, the ongoing marketing material suggesting that the device is fda-approved, and the continued mentions of addiction and pain management, in addition to anxiety, depression and insomnia, are clearly inconsistent with the content of communications from the fda. other suppliers market ces devices in a similar manner. healthpax, for instance, markets the ces ultra as enhancing "relaxed awareness, cognitive function, mental performance, memory and i.q." although it does not claim to be fda-approved, healthpax lists the device as having an fda registration number in a prominent place on the website, differentiating itself from other ces devices. quackwatch published a review of these technologies several years ago, last revised january 20, 2008, including links to the fda warning letters from 2004 for implied claims and recall from 2007 for peak voltage test difficulties, yet the technology continues to be advertised. 273 if a hazard threshold for regulation is the accepted threshold, 274 then relative neglect in this area is to be accepted for products that pose little direct risk. but as these technologies improve, it is likely that these products 273 stephen barrett, dubious claims made for nutripax and cranial electrotherapy stimulation, quackwatch, http://www.quackwatch.org/olquackeryrelatedtopics/ces.html (last updated jan. 28, 2008), archived at http://perma.cc/f54f-mhhr; see also warning letter to harold d. stecker, supra note 269; warning letter to daniel l. kirsch, supra note 269. 274 see katharine van tassel, regulating in uncertainty: animating the public health product safety net to capture consumer products regulated by the fda that use innovative technologies, including nanotechnologies, genetic modification, cloning, and lab grown meat, univ. chi. legal forum (2013). vol. 11:2548 can we trust consumers with their brains? will become more effective, and pose more subtle risks than electrocution by the battery operated ces device or turning blue from silver exposure. a question raised by this scenario is whether a more nuanced view of regulation, such as one informed by novelty of the claim rather than specific hazard of the device, should be the threshold for a requirement of findings of efficacy and risk prior to marketing. 275 while the fda and ftc likely lack the resources to carry out such an expanded mission, transparency to the consumer about what they do and do not regulate would be within their means and a step in the right direction. perhaps it is unreasonable to charge agencies already burdened by substantive regulation (i.e. product authenticity and safety) to regulate messages as well. 2 76 while risking slower innovation, in the area of selfimprovement technologies making health claims, there are perhaps some keyworded messages that should trigger demonstration of safety and efficacy before being made available in the marketplace. given that there are currently no uniform definitions of brain health and brain fitness, defining these terms and developing scientifically based standards for consumer application would seem a reasonable place to begin.277 what is likely to be more effective is improving consumer ability to evaluate claims made through more accessible and actionable information, be it through government websites, professional organization statements, or personal healthcare practitioners. in framing that which is normal, providing realistic information about the broad range of normal, providing credible and balanced information, and forcing the comparisons between new technologies and proven techniques to maintain health, we could potentially decrease consumer demand for these 275 id. 276 see generally quirk, supra note 175. 277 nussbaum, supra note 194, at 7 ("with consumers' growing interest in cognitive health, there is a vital need to define brain health and to rely on scientifically based standards for consumer application."). 2014 549 indiana health law review speculative products, increase consumer sophistication, and therefore encourage the exit of untested products making unproven claims from the marketplace. policy makers may also consider strategies that structure consumer choice, designate choice architects or nudge consumers toward better decisions. 278 to this end, policymakers may need to consider both increasing the persuasive power of credible information and limiting the persuasive powers of entities attempting to provide unproven products. vii. conclusion the collective fascination with brains as the basis of behavior is second only to the lack of working knowledge about them. progress, such as that promised by the human connectome project and brain, could do much to decrease consumer frustration and desperation that may increase the probability of turning to brain self-help products. in the interim, it is reasonable to predict that reporting related to these initiatives will contribute to ongoing public preoccupation with the brain. scientific discovery is big news. at a number of levels, public engagement is a driver of the discovery process. researchers may have been passive conveyers of experimental results in times past, but, currently, there are increasing calls for scientists to anticipate potential applications or extensions of their work and welcome a dialogue that may influence the scientist's study design and help the scientist frame results in a way that minimizes the risk of distortion. 279 how willing news outlets and other popular media are to be the vehicle of this discussion is a variable that has yet to be investigated. message matters. the brain is the current metaphor for humanity or personhood, and this rhetoric cannot be ignored or minimized; it must be managed. the brain is 278 sunstein & thaler, supra note 181; ubel, supra, note 181; jon d. hanson & douglas a. kysar, taking behavioralism seriously: the product ofmarket manipulation, 74 n.y.u. l. rev. 630 (1999). 279 see o'connor et al., supra note 35, at 225. 550 vol. 11:2 can we trust consumers with their brains? truly not like any other organ in the body and it is humbling to continue to learn that on a daily basis. research in the area needs to continue to mature in order to provide quality consumer information. currently, most brain function studies are relatively small studies of association, yet the information considered most reliable for consumers would likely come from large prospective studies from which causation might be inferred. scientists, journalists, clinicians and experts of all types have a responsibility to communicate brain-science findings to the public using clear and accurate language. while the usually conservative and conditioned language of science is not the stuff of great headlines or sound bites, to do otherwise is a disservice to the public, the science and the professions. enhancing consumer safety will likely involve some level of self-regulation of claims by scientists, journalists, and commercial entities. amongst the information offered to consumers should be mandatory disclosure of whether, and how, the technology in question changes brain function when compared to traditional activities used to achieve the same results such as exercise. even in minimal risk claims, some kind of proof of efficacy and screening of products making brain claims on a premarket basis should be undertaken because of the amount of current misinformation, rhetorical power of brain images, number of products being introduced, and prior abuses. errors affecting the brain could be costly and difficult to correct as this complex system is poorly understood at best. the risk-benefit analysis will, almost by definition, be incomplete. the information that consumers need in order to make better decisions includes the high level of complexity of brain science, limitations of both science and current products, and a frame for understanding the wide range of normal brain function. in prior studies, showing consumers realistic information and pointing out common mistaken biases resulted in improved decision making. leaving consumers with the notion that a brain that "lights up" is human, and one that does not is somehow less than human, is neither accurate nor useful. as a derivative, 2014 551 indiana health law review placing a burden on consumers to maximize their brains or fall ill ignores the realities that illness may occur no matter how "fit" a brain is, and decisions made about the expenditure of brainpower are likely more important than how much power brains generate. everything is a trade off. perhaps mandatory funding of independent studies and consumer education programs by brain self-improvement product authors, marketers, suppliers, manufacturers, and producers would be an important first step in being accountable to the public for claims made. it could result in real changes within the industries involved and provide ideas, data, or models for meaningful regulation. the lack of objective benchmarks for the outcomes of interest to consumers in brain science makes it difficult to evaluate claims and outcomes. regulation in the face of this level of scientific indeterminacy is no easy matter, but providing credible and balanced information in an accessible fashion and barring the frankly preposterous claim should be at least tentative goals. in short, we can trust the informed consumer with his or her brain if we provide accessible, credible, understandable, and, where appropriate, actionable information that is consistent across news, entertainment, and self-help outlets. vol. 11:2552 reconnecting the patient: why telehealth policy solutions must consider the deepening digital divide dr. laura c. hoffman* i. introduction one of the critical lessons already gleaned from covid-19 is the immense role technology can play in all aspects of our lives for everything from food shopping to healthcare access. but when technology becomes a larger part of our everyday lives, it begets a question: does everyone have access to the necessary technology? devices such as ipads, smartphones, and laptops can come with a hefty price tag. access to high-speed internet can also impose a challenge due to cost as well as availability in a given location, a barrier for many living in rural and urban areas. aside from affordability, there are several other reasons that particular populations may not be able to access technology. these include people generally not feeling comfortable using these devices, such as the elderly, people who find them too complicated, or the technology itself may not be designed in a way that accommodates specific needs, such as individuals with different disabilities or non-english speakers. for those with children, many of these issues impact the family as a unit. because of this, specific groups of people may have less or limited access to things like food delivery and healthcare – what we consider basic necessities – when technology has become a replacement or alternative for providing these goods and services. there is concern that moving forward, already existing disparities, particularly those involving healthcare, will worsen due to the “digital divide”* dr. laura c. hoffman is a visiting professor of law and acting director for the center for health law and policy at cleveland-marshall college of law. prior to this, dr. hoffman served as a senior research fellow with the solomon center for health law and policy at yale law school where she contributed to the development of projects and events involving palliative care policy, elder law, brain injury, and disability law. additionally, she worked as an assistant professor of law/faculty researcher for seton hall university school of law’s center for health and pharmaceutical law and policy where her work focused on research projects aimed at making policy changes to improve healthcare access for children and people with disabilities. previously, dr. hoffman worked for data federal corporation as a contract attorney advisor for the u.s. department of health and human services office of medicare hearings and appeals in the cleveland, ohio field office. she drafted appellate decisions for administrative law judges involving legal disputes over medicare payments. dr. hoffman earned her s.j.d. in health law and policy from loyola university chicago school of law in 2012. additionally, she holds a ll.m. in child and family law also from loyola and a second ll.m. in law and government from american university washington college of law with a concentration in civil and constitutional rights. dr. hoffman earned her j.d. from ave maria school of law in 2007. graduating cum laude and a distinguished graduate of the class of 2004, she earned a b.a. in political science from the university of notre dame. this article is dedicated in gratitude and loving memory of dr. hoffman’s mother, janet r. hoffman. 352 indiana health law review [vol. 19:351 the separation between those with access to technology and those without as described above. as our society continues to evolve beyond the covid-19 pandemic, much focus will center on how the landscape of providing healthcare can and should change as telehealth has become a prominent part of the healthcare story in the united states. since the covid-19 pandemic began in the u.s. in march 2020, the way in which healthcare has been delivered has drastically changed. even though telehealth was used prior to the pandemic, its use as a delivery method for medical care spiked tremendously as a result of the pandemic based on the need to help curb the spread of covid-19 and ensure people’s well-being by reducing in-person contact as much as possible. but there has been lower utilization of telehealth as the pandemic has progressed. “national survey data from the census bureau show a gradual decline in telehealth utilization among adults and children between april and october 2021.”1 additionally, on the provider side, it is still estimated that only 13% to 17% of healthcare delivery across specialties has involved the use of telehealth.2 researchers are currently trying to digest the use of telehealth as a means to deliver healthcare, clinicians are trying to learn how best to incorporate telehealth into their healthcare practice, and policymakers are attempting to determine what this means for the future regulatory implications of telehealth as the end of the pandemic approaches. thus, there will be a “new norm” for healthcare as well post-pandemic and the verdict is still out on how the use of telehealth clinically will be incorporated and how it will be regulated from a policy standpoint. while the use of telehealth has declined since the peak of the pandemic, its use is here to stay and many of the questions of how it needs to be regulated must be explored and answered.3 among them, how to ensure policy solutions are mindful of these issues involving the digital divide’s impact on various populations, which goes far beyond simply ensuring an adequate infrastructure.4 while much of telehealth focuses on providing access to healthcare by means of both audio and visual delivery, this is not possible for many individuals in thinking back to the concept of the “digital divide”. telehealth has already been criticized by some because it can, and potentially will, feed into this digital divide as those who can afford access to the necessary technologies including ipads, 1. madjid karimi et al., national survey trends in telehealth use in 2021: disparities in utilization and audio vs. video services, dep’t health & hum. servs. assistant sec. planning & eval. 1, 10 (feb. 2022), https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b 4885112b2994680a58af9ed/telehealth-hps-ib.pdf [https://perma.cc/dz2f-a3l3]. 2. oleg bestsennyy et al., telehealth: a quarter-trillion-dollar post-covid-19 reality?, mckinsey & co. (july 9, 2021), https://www.mckinsey.com/industries/healthcare-systems-andservices/our -in s igh t s / t e leh ea lth -a -q u ar t e r -t r i l l ion-dollar-post-covid-19-reality [https://perma.cc/p2yr-sllu]. 3. id. 4. david velasquez & ateev mehrotra, ensuring the growth of telehealth during covid19 does not exacerbate disparities in care, healthaffairs (may 8, 2020), https://www. healthaffairs.org/do/10.1377/hblog20200505.591306/full/ [https://perma.cc/726f-69hr]. 2022] reconnecting the patient 353 smartphones, and broadband internet, will also have greater access to healthcare through telehealth if it is more fully implemented into the norm of healthcare delivery. however, what research has already shown, and what needs to be further explored, is the audio-only option that was used by many to provide telehealth during the pandemic as well as the populations that were reached. this article hypothesizes that telehealth can and will thrive if telephone or audio-only access continues to some degree to be offered to provide healthcare for the populations who critics are quick to say cannot benefit from telehealth. while the audio-only modality of telehealth is not appropriate clinically for every healthcare situation or each individual’s needs, there are still many who may otherwise benefit from its availability. further, in addition to the audio-only telehealth modality option, efforts can and must be made to explore creating alternative places and spaces to offer both audio/visual telehealth options to these same populations. education to enable individuals to learn how to use technology appropriately will also be a critical component. finally, designers of these technologies for telehealth must make sure inclusion for all is at the forefront of design. in order to implement these mechanisms, policy solutions may come to bear on this to ensure equality. telehealth is not merely as good as the technology that brings it to us but as versatile as the methods by which we enable people to have access and the regulatory framework to likewise allow for its cohesion as demonstrated by issues like how we define telehealth (i.e., if expanded to include audio-only modality) and whether or not reimbursement is offered. this article will attempt to untangle the complicated web of providing telehealth to those populations it is potentially capable of further alienating from access to healthcare including: 1) race/minority populations, 2) aging adults, 3) individuals with disabilities, 4) non-english speakers, 5) individuals living in rural areas, 6) socioeconomic class, and 7) children, in order to advance the argument that telehealth can be successful in providing healthcare access to these populations. rather than suggesting that telehealth simply “cannot work” for these populations, instead consideration can and must meet these individuals through technology, access, and policy developments. first, this article will explain how telehealth is defined and how the definition has and can continue to influence policy development. next this article will explore the issues surrounding the “digital divide” and how this relates to telehealth use. then this article will discuss how access to technology impacts particular populations. this article will then consider legislation and policy developments both at the federal and state level that have emerged thus far that could help overcome challenges of accessibility, affordability, and useability. finally, this article will offer policy recommendations for ensuring that the delivery of telehealth can be accessible to those populations with potentially less access to technology to ensure telehealth’s successful availability and use for these populations can continue beyond covid-19. inevitably, the purpose of this article is to demonstrate that the future is still bright for the use of telehealth as seen initially in the audio-only option in the telephone call now that can allow a gap to be bridged for those populations that may not have the same access to technology in a variety of ways. another hope 354 indiana health law review [vol. 19:351 is to encourage the creation of other available options where these populations can also use both audio/visual options for telehealth as it is known that the audioonly option may not cater to every health situation clinically and the needs of various members of these populations. as telehealth is seen from this author’s perspective as supplemental to the in-person delivery of healthcare, there is no argument here that telehealth should ever replace in-person care or that telehealth, even in its best forms using both audio/visual components, can ultimately act to substitute in-person medical care completely. however, the expansion of options of telehealth from a regulatory standpoint as well as finding creative ways to make technology available and otherwise accessible for populations most at risk of not benefiting with the known gap of lack of access to technology can allow for telehealth to thrive for these populations and improve their access to healthcare rather than potentially worsen existing healthcare disparities. how is telehealth regulated beyond covid-19 and what does that mean for populations at greater risk for healthcare disparities? what role does accessibility play in formulating successful policy solutions involving telehealth? these are the questions this article ultimately hopes to provide insight to. ii. understanding telehealth generally a. introduction long before the covid-19 pandemic, telehealth has been used as a means of delivering healthcare at a distance via the use of technology.5 as a result of the pandemic, medical school education is now including training in telemedicine appointments.6 even how much will be spent on telehealth as an industry is unknown given the impact of covid-19.7 however, in order to more fully understand the impact of the explosion of telehealth since covid-198, it is critical 5. see world health org., telemedicine: opportunities and developments in member states (2009). 6. jamie ducharme, how u.s. medical schools are training a post-pandemic generation of doctors, time, https://time.com/5914062/medical-schools-coronavirus-pandemic/ [https://perma. cc/6yg7-2vgv] (last updated jan. 7, 2021). 7. kim harvey looney & molly august huffman, that was then and this is now—how the covid-19 crisis changed telehealth services: are the changes here to stay?, am. health l. ass’n (sept. 1, 2020), https://www.americanhealthlaw.org/content-library/connectionsmagazine/article/55a5ad47-302e-41f4-8e83-c1c1813c48a4/that-was-then-and-this-is-now-how-thecovid-19-cri?utm_term=&utm_medium=ppc&utm_campaign=awareness&utm_source= adwords&hsa_cam=1932380778&hsa_src=g&hsa_mt=b&hsa_ver=3&hsa_net=adwords&hsa_t gt=dsa-747633339513&hsa_acc=5596653348&hsa_grp=72466149978&hsa_kw= &hsa_ad=352494516217&gclid=cj0kcqiahzt9brdmarisan2e-j152bxauobx1u4r_ 5fifwjctp4pnbycc9_cd5vvb9e17nrggbpxtnmaaozsealw_wcb [https://perma.cc/law9flux]. 8. gabriela weigel et al., opportunities and barriers for telemedicine in the u.s. during the covid-19 emergency and beyond, kaiser fam. found. (may 11, 2020), https://www.kff.org/ 2022] reconnecting the patient 355 to know some general background of telehealth leading to this pivotal moment in time that will have a lasting impact on healthcare delivery. b. definition 1. what is “telehealth”? defining “telehealth” and related terms is not an easy task given the use of these terms from both a consumer and regulatory perspective.9 the center for connected health policy (“cchp”) defines telehealth as follows: “telehealth is a collection of means or methods for enhancing health care, public health and health education delivery and support using telecommunications technologies. telehealth encompasses a broad variety of technologies and tactics to deliver virtual medical, health, and education services. telehealth is not a specific service, but a collection of means to enhance care and education delivery.”10 cchp indicates the term “telehealth” is now more commonly used than “telemedicine” in policy as it describes “the wide range of diagnosis and management, education, and other related fields of health care.”11 federal agencies have also engaged in defining these terms. a frequently used definition of “telehealth” comes from the health resources and services administration (“hrsa”) of the federal office of rural health policy which defines telehealth as follows: telehealth is defined as the use of electronic information and telecommunication technologies to support long-distance clinical health care, patient and professional health-related education, public health, and health administration. technologies include video conferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.12 in march 2020, the centers for medicare and medicaid services (“cms”) advised medicare health providers “[t]elehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health.”13 cms defines womens-health-policy/issue-brief/opportunities-and-barriers-for-telemedicine-in-the-u-s-duringthe-covid-19-emergency-and-beyond/ [https://perma.cc/yh2m-47sv]. 9. matthew d. byrne, telehealth and the covid-19 pandemic, 35 j. perianesthesia nursing 548, 551 (2020). 10. what is telehealth?, ctr. connected health pol’y, https://www.cchpca.org/about/ about-telehealth [https://perma.cc/9f6l-93zu] (last visited mar. 9, 2022). 11. id. 12. what is telehealth?, health res. & serv. admin., https://www.hrsa.gov/rural-health/ telehealth [https://perma.cc/qhj9-34u4] (last updated sept. 2021). 13. medicare telemedicine healthcare provider fact sheet, ctrs. medicare & medicaid servs. (mar. 17, 2020), https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-healthcare-provider-fact-sheet [https://perma.cc/yn85-d7cv]. 356 indiana health law review [vol. 19:351 telemedicine for medicaid: “[t]elemedicine seeks to improve a patient's health by permitting two-way, real time interactive communication between the patient, and the physician or practitioner at the distant site. this electronic communication means the use of interactive telecommunications equipment that includes, at a minimum, audio and video equipment.”14 the definition of “telemedicine” used for medicaid was taken from medicare’s definition of “telehealth” as medicare does not provide a particular service for “telemedicine,” further demonstrating the complexity of understanding these terms and their distinctions.15 2. telemedicine vs. telehealth: the interchangeability of the terms telemedicine is generally understood as providing healthcare services at a distance between a patient and medical professional involving the use of technologies to communicate and deliver clinical services which can include evaluation, diagnosis, and treatment.16 the world health organization (“who”) has recognized the nature of telemedicine as an “open and constantly evolving science” that allows changeability for the concept’s definition to accommodate both technological developments and healthcare needs.17 frequently, the terms “telemedicine” and “telehealth” are distinguished with the latter referring more broadly to cover the use of various technologies to deliver medical, health, and education services in addition to clinical services rather than the narrower understanding of “telemedicine” which generally refers to remote delivery of clinical services.18 despite these specific distinctions, “telemedicine” and “telehealth” are often used synonymously or interchangeably.19 3. impact of definition on public policy the definition of telemedicine can have a significant impact on policy 14. telemedicine, medicaid, https://www.medicaid.gov/medicaid/benefits/telemedicine/ index.html [https://perma.cc/f9gj-6n3z] (last visited feb. 13, 2022). 15. id. 16. see world health org., supra note 5. 17. see id. 18. what is telehealth?, supra note 12. 19. the who has used the terms telemedicine and telehealth interchangeably in its own report on telemedicine. see world health org., supra note 5, at 9. the centers for disease control and prevention (“cdc”) has acknowledged that telemedicine and telehealth can be used interchangeably. see telehealth and telemedicine: a research anthology of law and policy resources, ctrs. disease control & prevention, https://www.cdc.gov/phlp/publications/ topic/anthologies/anthologies-telehealth.html [https://perma.cc/7vgc-th9n] (last updated july 31, 2019). the kaiser family foundation (“kff”) defines telemedicine/telehealth generally as “the remote provision of health care services using technology to exchange information for the diagnosis, treatment and prevention of disease” and acknowledges that the terms are used interchangeably. see weigel et al., supra note 8. 2022] reconnecting the patient 357 development.20 despite a myriad of definitions, what is clear at this point is that every state in the u.s. as well as the district of columbia (“d.c.”) have crafted definitions for “telemedicine,” “telehealth,” or a combination of these terms.21 for the purposes of consistency, this article will use “telehealth” and will apply the term interchangeably to both “telemedicine” and “telehealth.” a. general barriers to telehealth pre-pandemic a number of barriers already existed in access to telehealth pre-pandemic.22 among the most prevalent barriers that existed before the pandemic have included: • reimbursement • licensure • rural broadband gaps • existing healthcare disparities • online prescribing23 • privacy regarding patients’ health information in addition to these barriers, the way healthcare is administered between federal and state government has played a central role in shaping policy development. b. federal vs. state administration of telehealth24 a major contribution to the difficulties in removing barriers to implementation of telehealth prior to covid-19 has been the disjointed system of federal and state telehealth administration and policy.25 there has not been a uniform federal telehealth policy.26 additionally, there have been inconsistencies in the federal approach to telehealth.27 medicare has seen the most activity on the federal level in terms of telehealth but it has been far from ensuring accessibility to telehealth even before the pandemic.28 the current structure of regulation of health insurance markets has already 20. nicol turner lee et al., removing regulatory barriers to telehealth before and after covid-19, brookings inst. (may 6, 2020), https://www.brookings.edu/research/removingregulatory-barriers-to-telehealth-before-and-after-covid-19/ [https://perma.cc/6q6v-zya3]. 21. see state telehealth laws and medicaid program policies, ctr. connected health pol’y 1 (fall 2021), https://www.cchpca.org/2021/10/fall2021_executivesummary_final.pdf [https://perma.cc/cd4e-32d4]. 22. lee et al., supra note 20. 23. see laura c. hoffman, shedding light on telemedicine & online prescribing: the need to balance access to health care and quality of care, 46 am. j. law & med. 237 (2020). 24. id. 25. id. 26. telehealth policy 101, ctr. connected health pol’y, https://www.cchpca.org/ telehealth-policy/national-policy [https://perma.cc/dj47-4dxb] (last visited apr. 23, 2022). 27. lee et al., supra note 20. 28. id. 358 indiana health law review [vol. 19:351 played a role in the difficulties in telehealth policy. the federal government administers a number of healthcare programs that includes healthcare services for groups such as employees, the military, veterans, the elderly, and disabled individuals, representing only 15% of the population.29 however, there are distinctions in federal rules for telehealth such as medicare and the regulations in place at the state level further contributing to the complexity between different levels of government with different rules.30 the majority of health insurance purchased in the u.s. is regulated on the state level, making the state influence significant.31 states are also potentially much better suited for responding to people’s needs in the insurance market than the federal government.32 additionally, the state creates another layer of variation in telehealth policy.33 “no two states are alike in how telehealth is defined and regulated.”34 this could, in actuality, result in only increasing health inequity if these differences are vast: “similarly, if neighboring states do not have comparable medical licensing, telehealth malpractice, or online prescribing regulations, patients may have inequitable access regardless of their insurance coverage.”35 even prior to covid19, state law varied significantly regarding telehealth.36 iii. exploring disparities among the barriers that already existed before the pandemic, access to technology and what will be described as the “digital divide” as well as existing healthcare disparities went hand-in-hand, impacting relatively the same populations.37 the existence of the “digital divide” has been recognized globally.38 covid-19 saw the expansion of telehealth use with many physicians using telehealth for the first time, thus requiring patients to have access to technology when in-person visits were no longer an option.39 there is concern that if telehealth continues to aggressively be pursued and implemented as a 29. id. 30. id. 31. id. 32. id. 33. id. 34. state telehealth laws and medicaid program policies, supra note 21, at 3. 35. see elaine c. khoong, policy considerations to ensure telemedicine equity, health aff. (may 2022), https://www.healthaffairs.org/doi/10.1377/hlthaff.2022.00300 [https://perma. cc/g82h-sd8v]. 36. sydne enlund, increasing access to health care through telehealth, nat’l conf. state leg. (may 30, 2019), https://www.ncsl.org/research/health/increasing-access-to-health-carethrough-telehealth.aspx [https://perma.cc/6q94-wh9l]; see also lee et al., supra note 20. 37. lee et al., supra note 20. 38. anita makri, bridging the digital divide in health care, 1 lancet digital health e204, e204-e205 (2019). 39. telehealth impact: physician survey analysis, mitre corp., https://c19hcc.org/ telehealth/physician-survey-analysis/ [https://perma.cc/snn6-ckbb] (last updated nov. 16, 2020). 2022] reconnecting the patient 359 regular and more permanent method of providing healthcare, the groups with already existing healthcare disparities will only see these disparities exacerbated further. below, these existing disparities will be explored, as well as what current research has suggested in the potential furthering of these disparities in light of telehealth use. a. digital divide and the potential to exacerbate existing health disparities40 1. what is the “digital divide”? “the digital divide is one of the most pressing issues in telehealth.”41 the “digital divide” is generally understood as the inability to access telehealth as a means of providing healthcare which occurs through the combination of three primary points of accessibility: 1) individuals lacking access to technology, 2) a lack of digital literacy, and 3) the unreliability of internet coverage.42 it is known that certain populations of individuals are more likely to be impacted by the “digital divide” which includes the elderly, people of color, and individuals who fall into the category of low socioeconomic class.43 the digital divide existed before the pandemic.44 perhaps even more critical is that those falling into the digital divide are also those who have already been experiencing health disparities creating the potential for a double impact on these particular populations in healthcare access as telehealth becomes a more permanent part of healthcare 40. velasquez & mehrotra, supra note 4. 41. anuja vaidya, understanding key telehealth disparities & patient-facing barriers, xtelligent healthcare media (may 6, 2022), https://mhealthintelligence.com/features/ understanding-key-telehealth-disparities-patient-facing-barriers [https://perma.cc/g6lu-lkgp]. 42. id. 43. id.; see also ellerie weber et al., characteristics of telehealth users in nyc for covidrelated care during the coronavirus pandemic, 27 j. am. med. informatics ass’n 1949 (2020) (citing hyunwoo yoon et al., older adults’ internet use for health information: digital divide by race/ethnicity and socioeconomic status, 39 j. applied gerontology 105 (2020)); emily a. vogels, digital divide persists even as lower-income americans make gains in tech adoption, pew rsch. ctr. (june 22, 2021), https://pewrsr.ch/2vk1hio [https://perma.cc/re6j-nsrd]; andrew perrin & erica turner, smartphones help blacks, hispanics bridge some—but not all—digital gaps with whites, pew rsch. ctr. (aug. 20, 2019), https://policycommons.net/ a r t i f ac t s / 6 1 6 6 5 0 / sm ar tph on es-h e lp-b lacks-h ispan ics -br idge-som e/1 5 9 7 3 1 8 / [https://perma.cc/mw4h-s3wz]. 44. see bridging the digital divide for consumers: how health plans address the social determinants of health and promote access to telehealth, am. health ins. plans 1 (nov. 2020), h t tps:/ /www.ah ip.org/w p-con ten t /u p loads /2 0 2 0 1 1 -ahip_ib-digitaldivide.pdf [https://perma.cc/bpe3-v7h7] (“research conducted prior to the pandemic revealed that older americans, rural communities, vulnerable populations, racial and ethnic minorities, and those with lower socioeconomic status are disadvantaged by this ‘digital divide’ and may be unable to take full advantage of telehealth opportunities.”). 360 indiana health law review [vol. 19:351 delivery.45 despite this understanding above of the digital divide, from a policy standpoint, those issues suggest that even more significant problems are at play that can and should be recognized as part of the digital divide.46 up until this point, most policy recommendations have also only critically addressed one major aspect of this – trying to ensure broadband availability and improving infrastructure.47 however, there is much more to the digital divide that needs to be addressed for certain populations not to be left behind as described below. a. absence of access to technology the first area that contributes to the digital divide is access to technology. prior to the pandemic, a lack of access to the internet was identified as a significant issue.48 research indicates the severity of this absence of technology: although 80 percent of all u.s. households have access to the internet, data from the health information national trends survey suggest that significant disparities in internet access exist by age, sex, race, ethnicity, income, and education. likewise, as noted in ahrq’s 2018 national healthcare quality and disparities report, while some of the observed disparities have declined over the past two decades, many persist, especially for poor and uninsured populations in all priority areas.49 a population that is particularly impacted by an absence of technology is the elderly in terms of both computer ownership and internet access availability at home.50 other groups significantly impacted include children of minority groups51 and veterans who have received telehealth in rural areas but still face accessibility 45. shelly smith & sarah raskin, achieving health equity: examining telehealth in response to a pandemic, 17 j. nurse practitioners 214, 214 (2020). 46. nicol turner lee, can we better define what we mean by closing the digital divide?, hill (dec. 18, 2021), https://thehill.com/opinion/technology/586396-can-we-better-define-whatwe-mean-by-closing-the-digital-divide [https://perma.cc/t5an-gegv] (“the severity of the digital divide goes beyond the usual analogy of a three-legged stool — broadband availability, affordability, and digital literacy. policymakers must acknowledge that efforts to close the digital divide should also address poverty, geographic, and social isolation.”). 47. bhaskar chakravorti, how to close the digital divide in the u.s., harv. bus. rev. (july 20, 2021), https://hbr.org/2021/07/how-to-close-the-digital-divide-in-the-u-s [https://perma.cc/ 37wx-2kws]. 48. telediagnosis for acute care: implications for the quality and safety of diagnosis, agency healthcare rsch. & quality, https://www.ahrq.gov/patient-safety/reports/issuebriefs/teledx-5.html [https://perma.cc/3f22-5mjf] (last updated aug. 2020). 49. id. 50. see camille ryan & jamie m. lewis, computer and internet use in the united states: 2015, u.s. census bureau 1 (sept. 2017), https://www.census.gov/content/dam/census/library/ publications/2017/acs/acs-37.pdf [https://perma.cc/5swa-gv43]. 51. velasquez & mehrotra, supra note 4. 2022] reconnecting the patient 361 challenges.52additionally, non-english speakers may face challenges to accessing telehealth due to a combination of lack of access to technology and language barriers such as the lack of translating services.53 b. digital literacy having access to technology is not simply enough to ensure access to healthcare through telehealth. another contribution to the digital divide is digital literacy or how to actually use the technology in order to access telehealth services. digital literacy is particularly challenging for the elderly population which was evident prior to the pandemic: for 2018, we estimated that of all older adults in the united states, 13 million (38%) were not ready for video visits, predominantly owing to inexperience with technology. assuming individuals in the role of social supports knew how to set up a video visit, the estimated number of older adults who were still unready was 10.8 million (32%) telephone visits may reach more patients. nonetheless, an estimated 20% of older patients were unready for telephone visits because of difficulty hearing, difficulty communicating, or dementia.54 it has also been observed that those who are lacking digital literacy are more likely to be members of minority groups and/or of low socio-economic class.55 additionally, ensuring individuals have access to technology does not equate them possessing digital literacy to use the necessary technology which has been demonstrated for both the elderly and african american populations.56 those with limited english will also be less likely to use the technologies involved in telehealth even if they are available to them.57 further, the complexities of the video calls for non-english or limited english speakers will result in reliance on 52. lauren korshak & donna l. washington, telehealth disparities fact sheet, u.s. dep’t veteran aff. 1, 1-2 (nov. 2017), https://www.va.gov/healthequity/docs/telehealth_fact_ sheet.pdf [https://perma.cc/ncv9-34w5]. 53. nicole wetsman, telehealth wasn’t designed for non-english speakers, verge (june 4, 2020, 10:00 am), https://www.theverge.com/21277936/telehealth-english-systems-disparitiesinterpreters-online-doctor-appointments [https://perma.cc/e8lt-lam6]. 54. kenneth lam et al., assessing telemedicine unreadiness among older adults in the united states during the covid-19 pandemic, 180 jama internal med. 1389, 1389-1391 (2020). 55. see saida mamedova & emily pawlowski, a description of u.s. adults who are not digitally literate, stats brief 1 (may 2018), https://nces.ed.gov/pubs2018/2018161.pdf [https:// perma.cc/zbj9-99pn]. 56. see daniel m. walker et al., exploring the digital divide: age and race disparities in use of an inpatient portal, 26 telemedicine & e-health 603 (2020). 57. wetsman, supra note 53. see also sarah nouri et al., addressing equity in telemedicine for chronic disease management during the covid-19 pandemic, n.e. j. med. catalyst (may 4, 2020), https://catalyst.nejm.org/doi/full/10.1056/cat.20.0123 [https://perma.cc/85mm-bwjp]. 362 indiana health law review [vol. 19:351 telehealth in the form of telephone calls (audio-only) which may provide less information than physicians can obtain through observation on video calls.58 those who are non-english speakers have been less likely to use internet portals for healthcare prior to the pandemic further substantiating concerns that this population will be particularly vulnerable to the implementation of telehealth moving forward if there is not significant consideration to how to accommodate this population.59 there have been notable challenges in places like california: in california, nearly 44% of the population speaks a language other than english at home, and spanish-speaking physicians are the most underrepresented in the physician workforce. medical interpreter use will need to be systematically incorporated into telehealth technology to ensure language-concordance is addressed.60 efforts to ameliorate these issues such as in-person outreach and education sessions for these populations may be essential to ensure not being left behind if telehealth becomes an integral part of healthcare delivery post-pandemic, but will be problematic to implement until the u.s. is far beyond the pandemic when locations are experiencing less restrictions. even then, there is the fear factor of getting the technology but not knowing how to use it and knowing where to turn in order to acquire the assistance, education, and training necessary to use the technology.61 c. reliable internet coverage the availability of and access to internet service is not merely enough to ensure telehealth access. the reliability of internet service also plays a critical role in ensuring access. the exact extent of lack of broadband internet access in the u.s. is unsettled to some degree but generally known to be substantial.62 a lack of broadband access has been linked to underutilization of telehealth for those living in rural areas, “in fully rural counties, greater broadband access was associated with greater telemedicine use: counties with low broadband 58. nouri et al., supra note 57. 59. see alejandra casillas et al., a digital language divide? the relationship between internet medication refills and medication adherence among limited english proficient (lep) patients, 5 j. racial & ethnic health disparities 1373 (2018). 60. see yohualli balderas-medina anaya et al., telehealth & covid-19: policy considerations to improve access to care, ucla latino pol’y & pol. initiative 1, https:// lat ino.ucla.edu /wp-conten t/uploads/2020/05 /teleh ea lth -c o v id -19-report .pdf [https://perma.cc/6lfe-fn22] (last visited mar. 13, 2022). 61. judith graham, calming computer jitters: help for seniors who aren’t tech-savvy, kaiser fam. found. (june 24, 2021), https://khn.org/news/article/calming-computer-jitters-helpfor-seniors-who-arent-tech-savvy/ [https://perma.cc/e6rn-6k8w]. 62. sophia campbell et al., the benefits and costs of broadband expansion, brookings inst., https://www.brookings.edu/blog/up-front/2021/08/18/the-benefits-and-costs-of-broadbandexpansion/ [https://perma.cc/a8qq-vgwt] (last updated nov. 9, 2021). 2022] reconnecting the patient 363 availability had 34% fewer visits per capita compared with counties with high broadband availability (13.4 per 1000 vs 20.4, p = .004).”63 the broadband coverage rates in 2018 demonstrate the prevalence of this challenge, “fcc filings show that 24 million americans still don’t have access to broadband internet at home in 2018. millions more can only get slow, unreliable dsl service. many of the ‘dark spots’ are in states with large swaths of rural, economically disadvantaged areas.”64 in 2019, access to broadband still remained significantly difficult for americans living in rural areas compared to those in both urban and suburban areas.65 the fcc’s most recent estimate regarding lack of broadband access is at approximately 19 million – with 14.5 million coming from those living in rural areas.66 however, there is additional research in 2020 to suggest even current fcc numbers are inaccurate and that it is likely double this amount are without broadband access.67 this is due to a difference in methodology in calculating these numbers which the group broadbandnow research performed by address.68 in 2021, it was estimated that 45% of those living in rural areas lacked broadband access by research performed by the bipartisan policy center.69 while much attention has been focused on broadband internet access for rural areas, urban areas have been facing similar struggles.70 the pandemic has only contributed to the importance of broadband access due to the use of telehealth. a study released in march 2022 indicated that more individuals who were african 63. see andrew d. wilcock et al., association between broadband internet availability and telemedicine use, 179 jama internal med. 1580 (2019). 64. see tyler cooper, us states with the worst and best internet coverage 2018, broadbandnow (aug. 14, 2018), https://broadbandnow.com/report/us-states-internet-coveragespeed-2018/ [https://perma.cc/r8dm-ty2s]. 65. andrew perrin, digital gap between rural and nonrural america persists, pew rsch. ctr. (june 3, 2019), https://www.benton.org/headlines/digital-gap-between-rural-and-nonruralamerica-persists-0 [https://perma.cc/6tla-gtqp]. 66. eighth broadband progress report, fed. commc’ns comm’n, https://www.fcc.gov /reports-research/reports/broadband-progress-reports/eigh th-broadband-progressreport#:~:text=notwithstanding%20this%20progress%2c%20the%20report,lack%20access%2 0to%20this%20service [https://perma.cc/sdn2-8lnf] (last visited may 10, 2022). 67. john busby et al., fcc reports broadband unavailable to 21.3 million americans, broadbandnow study indicates 42 million do not have access, broadbandnow rsch. (oct. 21, 2021), https://broadbandnow.com/research/fcc-underestimates-unserved-by-50-percent [https:// perma.cc/7p4z-uftn]. 68. linda poon, there are far more americans without broadband access than previously thought, bloomberg (feb. 19, 2020, 3:09 pm), https://www.bloomberg.com/news/articles/202002-19/where-the-u-s-underestimates-the-digital-divide [https://perma.cc/k8cd-3cum]. 69. jazmyne sutton, telehealth visit use among u.s. adults, bipartisan pol’y ctr. (aug. 2021), https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2021/08/ssrs-telehealthreport_confidential_final_08.02.21-1.pdf [https://perma.cc/ph6c-l68s]. 70. juan pablo garnham, millions of texans still don’t have broadband access. some lawmakers are trying to change that, tex. tribune (mar. 8, 2021, 11:00 am), https://www. texastribune.org/2021/03/08/internet-broadband-texas/ [https://perma.cc/saf5-mqn7]. 364 indiana health law review [vol. 19:351 american or non-hispanic white that died from covid-19 lacked internet access thus also limiting access to telehealth.71 lack of internet was also shown to contribute to covid-19 mortality rates in urban areas.72 “broadband access has been increasingly named as an explicit social determinant of health during the covid-19 pandemic.”73 b. early evidence of disparities in healthcare access from use of telehealth during covid-19 and looking beyond the immediate question that emerges is whether an expansion of telehealth in the delivery of healthcare would exacerbate existing healthcare disparities for groups already discussed. initial research thirty days after telehealth expansion during the covid-19 public health emergency revealed a number of disparities based on gender, age, race, geographic location, and type of payer.74 however, it is important to note that this study had its limitations and recommended future research was necessary.75 another study evaluated telehealth use for primary and specialty care in a large academic hospital system during the pandemic finding “older age, asian race, non-english language as the patient’s preferred language, and medicaid were independently associated with fewer completed telemedicine visits . . . .”76 this initial research suggested the policy implications, especially for reimbursement policy, must consider these disparities moving forward.77 additional research has further demonstrated disparities directly or suggested their potential with telehealth expansion. 1. race/minority populations78 among the groups with recognized health disparities that may be further 71. qinyun lin et al., assessment of structural barriers and racial group disparities of covid-19 mortality with spatial analysis, 5 jama network open 1, 9 (2022). “in addition, most concentrated longitudinal-impact counties with large black or african american (244 of 347 [70.3%]) and non-hispanic white (21 of 33 [63.6%]) populations compared with other counties had higher percentages of households without access to the internet.” id. 72. id. 73. smith & raskin, supra note 45 (citing natalie c. benda et al., broadband internet access is a social determinant of health!, 110 am. j. pub. health 1123 (2020)). 74. see robert p. pierce & james j. stevermer, disparities in use of telehealth at the onset of the covid-19 public health emergency, j. telemedicine & telecare 1 (2020). 75. see id. 76. see lauren a. eberly et al., patient characteristics associated with telemedicine access for primary and specialty ambulatory care during the covid-19 pandemic, 3 jama network open 1 (2020). 77. see id. 78. craig konnoth et al., how telehealth could improve — or worsen — racial disparities, harv. l. petrie-flom ctr. (oct. 8, 2020), https://blog.petrieflom.law.harvard.edu/2020/10/08/ telehealth-racial-disparities-covid19/ [https://perma.cc/wl2e-p4qa]. https://perma.cc/wl2e-p4qa 2022] reconnecting the patient 365 impacted by telehealth expansion are those based on race or minority populations. although research between race and telehealth use was conflicting prior to the pandemic, the initial 30-day review found that there was a notable health disparity for blacks and telehealth use in the initial expansion of telehealth during covid-19.79 further research has substantiated the relationship between race/ethnicity and limited telehealth use since the pandemic. a study that examined data from the peak of the pandemic in new york city demonstrated that both blacks and latinos saw greater use of both emergency department (“ed”) visits and in-person healthcare visits rather than use of telehealth for healthcare compared to whites.80 another study examining cancer care for both blacks and hispanics during the pandemic in new york city at its height also recognized the decreased use of telehealth for these populations.81 another complication created by covid-19 has been the fact that many in these populations depend on community health centers (“chcs”) for access to healthcare where it has been shown there have been fewer weekly visits and where a majority of chcs used telehealth to provide healthcare during the pandemic, suggesting that this could contribute to intensifying already existing healthcare disparities.82 recent research published in the journal of racial ethnic health disparities identified the lack of access to digital health information for older individuals of racial and ethnic groups—an example of the direct impact of this divide.83 2. aging adults another population deserving attention in telehealth is the elderly population (defined as those age 65 and older).84 early polling by kff during the pandemic in april found that although the elderly population was utilizing telehealth, there are still numerous barriers in terms of technology access and use.85 kff stated: 79. see pierce & stevermer, supra note 74. 80. see weber et al., supra note 43. 81. john derosier, substantial racial disparities observed in use of telehealth by patients with cancer, healio (oct. 12, 2020), https://www.healio.com/news/hematology-oncology /20201012/substantial-racial-disparities-observed-in-use-of-telehealth-by-patients-with-cancer [https://perma.cc/cx7p-4lvf]. 82. june-ho kim et al., how the rapid shift to telehealth leaves many community health centers behind during the covid-19 pandemic, healthaffairs (june 2, 2020), https://www. healthaffairs.org/do/10.1377/hblog20200529.449762/full/ [https://perma.cc/gl9j-aht6]. 83. see ruth m. tappen et al., digital health information disparities in older adults: a mixed methods study, 9 j. racial & ethnic health disparities 82 (2022). 84. andis robeznieks, why so many patients still can’t connect to doctors via telehealth, ama (aug. 7, 2020), https://www.ama-assn.org/practice-management/digital/why-so-manypatients-still-can-t-connect-doctors-telehealth [https://perma.cc/t3mw-r2yp]. 85. juliette cubanski, possibilities and limits of telehealth for older adults during the covid-19 emergency, kaiser fam. found. (apr. 13, 2020), https://www.kff.org/policy-watch/ possibilities-and-limits-of-telehealth-for-older-adults-during-the-covid-19-emergency/ 366 indiana health law review [vol. 19:351 while it might not be too surprising that a relatively small share of people ages 65 and older say they’ve used an internet-connected device for video communication with a health care provider in recent weeks, this finding might put some realistic bounds on expectations for use of telehealth by people with medicare during the covid-19 emergency. at the same time, we might expect this share to increase somewhat as more patients learn about the option to seek medical care from their providers via telehealth. family members might also be encouraging their older relatives to use telehealth in order to safely receive care they may need from their own homes.86 despite the interest in the elderly population in using technology for healthcare, this group used telehealth less frequently in the early stage of the pandemic compared to younger populations.87 because of this, age is considered a significant factor in telehealth utilization.88 3. disability another group where there is concern for telehealth expansion is people with disabilities.89 “while telemedicine improves access and reduces barriers to healthcare access for many, several barriers and challenges remain for persons with disabilities, and novel challenges have been exposed during the covid-19 pandemic—many of which may persist long-term.”90 a number of disparities impact healthcare access for people with disabilities that have existed prior to the pandemic.91 while telehealth became a primary means of healthcare during the pandemic due to the need to limit in-person contact, people with disabilities who had challenges in using technology could not easily take the option of in-person visits as they could during a normal time outside of a public health emergency.92 because telehealth is expected to remain an integral part of healthcare moving forward as an alternative, the previous issues encountered for people with disabilities in healthcare access must be revisited in light of this conversion of healthcare delivery through the use of technology.93 while there are benefits to telehealth for people with disabilities including “lower transportation costs, improved medication reconciliation communication, less exposure to [https://perma.cc/6cz2-79xa]. 86. id. 87. dena h. jaffe et al., health inequalities in the use of telehealth in the united states in the lens of covid-19, 23 pop. health mgmt. 368, 371 (2020). 88. id. 89. see thiru m. annaswamy et al., telemedicine barriers and challenges for persons with disabilities: covid-19 and beyond, 13 disability & health j. 1 (2020). 90. see id. 91. see id. 92. see id. 93. see id. 2022] reconnecting the patient 367 communicable diseases especially during a pandemic, and decreased need for paid personal assistance services”, it is critical to consider the challenges this transition to technology-based medical care could pose in further implementation as the pandemic nears an end.94 the significance of exploring the challenges for people with disabilities in telehealth access and developing strategies is critical as it can embrace intersectionality for other populations already discussed that are also embedded into the disabled population.95 one current major barrier for telehealth access for people with disabilities is the design of telehealth technologies whether those are provided through websites or apps having accessibility issues preventing people with disabilities from being able to utilize these technologies.96 a push and movement for “inclusive innovation”, described as the involvement of people with disabilities in the design of technologies, is emerging and which will be essential in ultimately ensuring the ability of this population to use technology.97 “achieving inclusive innovation in telehealth, means changing the practice of medicine.”98 implementation of telehealth in terms of internet service as well as the ability of people with disabilities to use the telehealth technologies have also been raised as issues of concern for telehealth expansion.99 despite the existence of both federal anti-discrimination law and federal healthcare protections for people with disabilities, there is concern that the lack of knowledge about these protections as well as the continued lack of guidance by the u.s. department of justice by failing to provide website accessibility regulations that would impact telehealth suggest major policy concerns for telehealth access for people with disabilities moving forward if left unaddressed.100 in march 2022, the u.s. department of justice released the long overdue website accessibility guidelines for websites in the hopes of preventing this inaccessibility.101 the ada was written in the 1990s, a time when the internet was just developing and technology was not a prominent part of every day life that it is now.102 however, the much anticipated guidance by the department of justice on website accessibility has already received criticism for its lack of force: 94. see id. 95. see rupa s. valdez et al., ensuring full participation of people with disabilities in an era of telehealth, 28 j. am. med. informatics ass’n 389(2021). 96. see id. 97. see kimberly noel & brooke ellison, inclusive innovation in telehealth, 3 npj digital med. 1 (2020). 98. see id. 99. see valdez et al., supra note 95. 100. see id. 101. guidance on web accessibility and the ada, am. disability act, https://beta.ada.gov/ web-guidance/ [https://perma.cc/z22j-43ge] (last visited may 10, 2022). 102. steven aquino, department of justice announces new web accessibility guidelines, forbes (mar. 21, 2022, 12:22 pm), https://www.forbes.com/sites/stevenaquino/2022/03/21/ department-of-justice-announces-new-web-accessibility-guidelines/?sh=5eab6e7c4bb4 [https://perma.cc/ys76-axsn]. 368 indiana health law review [vol. 19:351 targeted businesses, which have aggregately paid out millions of dollars in extortive settlement payments, were eagerly waiting for the u.s. department of justice (doj) – as the agency charged with issuing regulations to carry out the force and effect of ada – to use its regulatory authority to provide clarity as to what series of steps can be taken to certify a website’s accessibility. to their chagrin, on march 18, 2022, the doj effectively abstained and, instead of regulating, issued a nonbinding sub-regulatory statement called web accessibility guidance under the americans with disabilities act, which purports to describe how businesses can ensure that their websites are accessible. unfortunately, it does no such thing. the doj’s ineffective course makes it all the more important for congress to step in to curb predatory website accessibility lawsuits.103 thus, it seems that the issues involving website accessibility are likely far from over. additionally, privacy concerns may also be more severe for people with disabilities requiring the reexamination of u.s. privacy law to ensure appropriate measures are taken to protect the health information of people with disabilities.104 4. non-english speakers non-english speakers represent another group of important consideration with concerns in telehealth expansion. several of the barriers have already been discussed including access to technology as well as the useability of the technology. there is evidence that these barriers have already impacted nonenglish speakers during the pandemic in accessing healthcare resulting in canceling of appointments because it was not understood these were converted to telephone appointments due to communication difficulties.105 5. rural those living in rural areas have been known to experience health disparities.106 “rural communities face lower access to healthcare, health services, and health insurance compared with urban settings.”107 for many healthcare providers in rural areas, the covid-19 pandemic, which required the 103. martin krezalek, doj’s failure to provide effective guidance on website accessibility requirements under the ada leaves congress as the only option to address the problem of abusive lawsuits, jdsupra (apr. 29, 2022), https://www.jdsupra.com/legalnews/doj-s-failure-toprovide-effective-8306925/ [https://perma.cc/6d9r-xclp]. 104. see valdez et al., supra note 95. 105. wetsman, supra note 53. 106. see kelly a. hirko et al., telehealth in response to the covid-19 pandemic: implications for rural health disparities, 27 j. am. med. informatics ass’n 1816 (2020). 107. see id. 2022] reconnecting the patient 369 limitation of in-person visits, resulted in the transformation of healthcare delivery through the use of telehealth for the first time as seen in michigan.108 the primary concern raised during the pandemic regarding this transition for rural populations did exist prior to the pandemic—access to broadband internet.109areas with low broadband internet access “also have a higher prevalence of obesity, diabetes, and chronic diseases,” indicating that this group may have the most significant healthcare needs.110 thus, continued telehealth expansion holds significant promise for this population but must address the potentially significant barrier created by lack of broadband access that could otherwise play a role in exacerbating existing healthcare disparities.111 6. socioeconomic class individuals with low income or a lower socioeconomic class were less likely to use telehealth prior to the pandemic. even a study in which state telehealth policies were changed to expand the ability to use telehealth indicated those individuals who were low income were still not any more likely to use telehealth.112 looking at the pandemic and beyond, there is significant concern that health care providers in low-income communities will be so financially hurt by the pandemic to result in closures.113 telehealth is not envisioned as a solution to this dilemma either, given the access to technology challenges previously described for minority groups.114 as far as telehealth and healthcare, policies generally must account for these realities. 7. children another area where there has been substantial growth in telehealth use through the course of the pandemic has involved children in pediatrics.115 while the use was significantly low in pediatric primary care before the pandemic (approximately 15% as of 2016), the pandemic saw the level of telehealth use skyrocket in pediatrics due to the waiver of many cms regulations. for example, shortly after cms waivers went into effect in march 2020, there was a 154% 108. see id. 109. see id. 110. see hirko et al., supra note 106. 111. see id. 112. see jeongyoung park et al., are state telehealth policies associated with the use of telehealth services among underserved populations?, 37 health aff. 2060 (2018). 113. shivani a. shah et al., supporting health care delivery in low-income areas during covid-19, healthaffairs (july 17, 2020), https://www.healthaffairs.org/do/10.1377/hblog202 00715.332672/full/ [https://perma.cc/bj5r-vuqf]. 114. id. 115. see alison curfman et al., pediatric telehealth in the covid-19 pandemic era and beyond, 148 pediatrics 1 (2021). 370 indiana health law review [vol. 19:351 increase in telehealth visits compared with the same time frame in 2019.116 however, there is still variability among research suggesting the need to standardize evaluations of telehealth use.117 while there are potential benefits for pediatric telehealth use, there are also several possible drawbacks: there has been cautious optimism that telehealth may reduce inequities in access to pediatric care, especially for children in low-income families and children whose families have limited access to transportation or difficulties taking time off from work to access in-person health care. at the same time, there are concerns that telehealth may exacerbate disparities in utilization due to existing disparities in access to technology or knowledge/information about telehealth by race/ethnicity, rural location, and family income.118 similar to other groups already discussed, there is concern that if not done appropriately, telehealth will increase health equity for children based on a number of factors: for instance, lack of access to internet, smartphones, or other technology should not prevent children from accessing their medical system. highquality interpretation and adaptive technology should also be available for families with limited english proficiency and hearing or vision impairment.119 research conducted on alabama children’s healthcare program demonstrated that children in both rural and lower income families were less likely to utilize telehealth.120 further, the study demonstrated the potential for lower use of telehealth by black and hispanic children compared to white children.121 the variation in availability of telehealth to children and families could result in only certain populations benefiting from telehealth use and pushing those already marginalized further entrenched into existing healthcare disparities. iv. current legislative efforts to combat the digital divide in telehealth access there are several notable ways we are already beginning to see legislation and policy efforts at both the federal and state levels attempt to bridge the gap of the digital divide that if otherwise unavailable, may only result in more severe healthcare disparities for these populations by depriving them access to telehealth 116. see id. 117. see id. 118. see bisakha sen et al., disparities in telehealth utilization in a population of publicly insured children during the covid-19 pandemic, 25 pub. health mgmt. 178 (2022). 119. see curfman et al., supra note 115. 120. see sen et al., supra note 118. 121. see id. 2022] reconnecting the patient 371 as a healthcare delivery option. some of these changes have been only temporary as a result of the pandemic while others have become permanent. while this does not intend to provide an exhaustive overview of these efforts, it is designed to provide insight as to some of the overall policy considerations beyond the pandemic. a. telehealth modality: expanding coverage for audio-only telehealth prior to the pandemic, audio-only telehealth was not embraced as an accepted modality of telehealth, however, this drastically changed due to accessibility issues and the ability to have continued access to patients during the pandemic rather than without.122 although there are several benefits to having a telehealth encounter that is both audio and visual, there are challenges to providing video visits: although research shows that video visits offer some additional benefits compared with telephone visits. they require more complex setup, video-enabled devices, and broadband internet access, which may present barriers for older adults, lower income households, and those with limited english proficiency. in addition to these factors, patients with lower incomes may be more likely to use audio-only services because they are at work during appointments or lack privacy at home.123 while it may not ultimately become a permanent option in all places, there is support for even the temporary availability of the audio-only modality of telehealth until the more significant issues involving the digital divide have been remedied: “as policy makers deliberate on the future of infrastructure and health care, they should consider how pressing needs are addressed in the immediate term. the telephone, a cheap and accessible tool, already exists to provide access to some forms of health care. audio-only telehealth can and should serve as a bridge until two-way synchronous telehealth is affordable and accessible for all patients.”124 as we will see below, additional research involving federally qualified health centers (“fqhcs”) further suggests the importance of offering the availability of audio-only telehealth at least on a temporary basis unless and until the other issues contributing to the digital divide can be resolved. further, a 2021 issue brief by the u.s. department of health and human services (“hhs”) indicated that certain populations were less likely to use video visits.125 122. quinn hirsch et al., beyond broadband: equity, access, and the benefits of audio-only telehealth, healthaffairs (sept. 20, 2021), https://www.healthaffairs.org/do/10.1377/forefront. 20210916.819969/full/ [https://perma.cc/9cb9-brxh]. 123. see karimi et al., supra note 1. 124. hirsch et al., supra note 122. 125. see karimi et al., supra note 1. “conversely, groups with lower odds of using videoenabled telehealth services were respondents who selfidentified as latino, black, or asian american / pacific islander; men; those with lower education and income, and those living in the midwest.” id. at 8. 372 indiana health law review [vol. 19:351 1. federal efforts a. medicare as the pandemic began, cms responded by altering many provisions under medicare to allow for much more expansive healthcare access which included telehealth. in march 2020, this allowed telehealth to be covered where it previously had not been such as expanding the originating site requirement (i.e., that the telehealth encounter would have to take place from a particular location) to include the ability to conduct the telehealth encounter from the patient’s home as a site covered by medicare.126 this also included allowing coverage for far more telehealth services overall under medicare: “cms also added 135 allowable services, more than doubling the number of services that beneficiaries could receive via telehealth.”127 in addition to these major changes, audio-only telehealth was also allowed and provided coverage which had previously not been in the realization that the availability of this modality of telehealth could benefit many medicare beneficiaries: the trump administration has also removed other barriers that may limit beneficiary access to telehealth services. usually, interactive audio-video technology is required for telehealth visits. this can be a challenge for beneficiaries; often, they either don’t have access to the technology or choose not to use it even if offered by their practitioner.128 in the area of behavioral health, services were also expanded through medicare to ensure greater availability of the audio-only modality.129 research has already demonstrated that the expansion of these provisions under telehealth resulted in significant utilization of telehealth for medicare beneficiaries during the pandemic than was observed prior.130 decisions are starting to be made in 126. seema verma, early impact of cms expansion of medicare telehealth during covid19, healthaffairs (july 15, 2020), https://www.healthaffairs.org/do/10.1377/hblog20200715. 454789/full/ [https://perma.cc/5hqe-y3gx]. 127. id. 128. id. 129. id. (“soon after, cms went even further to eliminate these barriers by paying for certain telephone evaluation and management visits and behavioral health services and paying practitioners at the same rate as similar in-person services.”). 130. id. (“with wide-ranging telemedicine flexibilities, there has been a surge in the number of beneficiaries getting telemedicine services. before the public health emergency, approximately 13,000 beneficiaries in fee-for-service (“ffs”) medicare received telemedicine in a week. in the last week of april, nearly 1.7 million beneficiaries received telehealth services. in total, over 9 million beneficiaries have received a telehealth service during the public health emergency, midmarch through mid-june. specifically, data points presented in this section of the post are from internal cms analysis of medicare ffs claims data from march 17 through june 13, 2020 (using data processed through june 19, 2020). telemedicine services include services on the medicare telehealth list including audio-only visits, as well as virtual check-ins and e-visits.”). 2022] reconnecting the patient 373 thinking about the flexibilities that have been created under medicare as there is consideration in terms of whether these changes should stay temporary or permanent after the pandemic with the most recent fee schedule for 2022 continuing to make audio-only telehealth available involving behavioral health services.131 further, the consolidated appropriations act for fiscal year 2022132 (“2022 caa”) was signed into law by president biden on march 16, 2022 to provide a variety of medicare flexibilities involving telehealth for 151 days past the end of the public health crisis including: easing geographic restrictions and continue to allow original site to be in the patient’s home, expansion of eligible practitioners, particular mental health services, coverage and payment for most audio-only services as well as expanding funding for rural areas.133 the american hospital association (“aha”) has stressed the significance of these changes yet advocates for the necessity of more permanent changes for telehealth beyond the pandemic.134 b. medicaid medicaid largely followed the lead of medicare in expanding telehealth to include the audio-only option.135 “state medicaid programs, many of which did not cover audio-only telehealth prior to the pandemic, followed suit in expanding 131. revisions to payment policies under the medicare physician fee schedule quality payment program and other revisions to part b for cy 2022 (cms-1751-f), ctrs. medicare & medicaid servs. (nov. 19, 2021), https://www.cms.gov/medicaremedicare-fee-servicepaymentphysicianfeeschedpfs-federal-regulation-notices/cms-1751-f [https://perma.cc/ha7y-xm x5]; see also calendar year (cy) 2022 medicare physician fee schedule final rule, ctrs. medicare & medicaid servs. (nov. 2, 2021), https://www.cms.gov/newsroom/fact-sheets/ calendar-year-cy-2022-medicare-physician-fee-schedule-final-rule [https://perma.cc/7zcd-8xzb]. 132. consolidated appropriations act of 2022, h.r. 2471, 117th cong. (2021). 133. joelle m. wilson & laura little, congress grants five month extension for telehealth flexibilities, nat’l l. rev. (mar. 17, 2022), https://www.natlawreview.com/article/congressgrants-five-month-extension-telehealth-flexibilities#:~:text=2471%2c%20the%20consolidated% 2 0 appropr ia t ion s% 2 0 act ,e m erg e n c y% 2 0 ( % e 2 % 8 0 % 9 c p he % e 2 % 8 0 % 9 d ) [https://perma.cc/5tjp-y2v5]. 134. rick pollack, extending telehealth flexibility to safeguard access to virtual care, am. hospital ass’n (mar. 18, 2022, 11:25 am), https://www.aha.org/news/perspective/2022-03-18extending-telehealth-flexibility-safeguard-access-virtual-care#.yjixbix4g8g.twitter [https://perma.cc/7kmp-c45e]. “while we were are grateful for these actions, making these waivers permanent is essential so we can protect access to vital telehealth services in every community. we also will continue to advocate that critical access hospitals have the flexibility to continue providing telehealth care for patients and communities, especially behavioral health services.” id. 135. edward kornreich & daniel weinstein, hold the phone: audio-only telehealth expanding in new york and other states, but national policies may lag, jd supra (may 13, 2021), https://www.jdsupra.com/legalnews/hold-the-phone-audio-only-telehealth-9422897/ [https:// perma.cc/9fum-utrq]. 374 indiana health law review [vol. 19:351 coverage to include varying degrees of audio-only telehealth services.”136 this has continued as research has demonstrated the continued expansion across the states in medicaid programs allowing coverage for audio-only telehealth as a modality: audio-only reimbursement, saw the biggest jump, with 22 medicaid programs reimbursing the modality (up from 15 in spring 2021). this is likely a result of policies during the pandemic either being made permanent or being extended multiple years into the future, although often on a more limited basis than what was allowed during the covid19 public health emergency (phe).137 it is arguable that medicaid may continue, as it has, to take direction from what further and permanent changes cms may implement regarding audio-only telehealth for medicare. in its most recent spring 2022 analysis of state medicaid policy, cchp identified the following with regard to states adopting policies in their medicaid programs for audio-only modality of telehealth: “twenty-nine states and dc medicaid programs reimburse for audio-only telephone in some capacity; however, often with limitations. for example, michigan only reimburses for it when used for provider-to-provider electronic consultations.”138 unlike medicare where administration of policy is at the federal level, much of medicaid policy is developed at the state-level which is part of the flexibility of the program even with federal oversight as this demonstrates.139 likewise, this also means that healthcare coverage for services, including audio-only telehealth, can vary substantially across state lines. c. possible federal legislation? as indicated in a previous section, there is currently no federal or national policy regarding telehealth. however, various federal proposals have been made that have considered the possibility of telehealth expansion to include the audioonly modality in some form. the ensuring parity in ma and pace for audioonly telehealth act of 2021 was designed to allow for audio-only telehealth diagnosis under certain medicare plans.140 another bill that has been introduced is the creating opportunities now for necessary and effective care technologies (“connect”) for health act of 2021 is another proposal for 136. id. 137. see state telehealth laws and medicaid program policies, supra note 21. 138. id. at 4. 139. see samantha artiga et al., current flexibility in medicaid: an overview of federal standards and state options, kaiser fam. found. (jan. 2017), https://files.kff.org/attachment/ issue-brief-current-flexibility-in-medicaid-an-overview-of-federal-standards-and-state-options [https://perma.cc/ns6c-j8jy]. 140. ensuring parity in ma and pace for audio-only telehealth act of 2021, s. 150, 117th cong. (2021). 2022] reconnecting the patient 375 expanding telehealth regarding medicare.141 the permanency for audio-only telehealth act is a federal bill which specifically includes focus on providing coverage for audio-only telehealth services under medicare.142 the protecting rural telehealth access act aims to focus particularly on those in rural areas as well as telehealth access to fqhcs.143 the telehealth modernization act also attempts to potentially rectify issues involving medicare to provide greater flexibility for telehealth services.144 the proposed legislation above has been in response to an understanding that cms will not inevitably permanently expand all the changes it has made to ease telehealth restrictions during the pandemic and suggested the need for congressional action to make certain changes more permanent (for example, beyond what was provided by the congress with the 2022 caa). whether or not any federal legislation passes regarding these issues will likely be dependent on the permanency of any changes particular to the audio-only telehealth modality involving medicare and medicaid. at this point, the fact that there is movement towards trying to make the audio-only modality of telehealth a more permanent reality in some respect suggests that there is potential value in its continued use beyond the pandemic as an option for healthcare delivery. 2. legislation at the state level state laws on telehealth can and will differ substantially.145 since 2020, even during the height of the pandemic, states began to initiate and even adopt legislative changes that would impact the availability of audio-only telehealth as a modality which was first seen in the state of new york.146 while new york had previously excluded audio-only telehealth in its definition of “telehealth,” this was changed to include “audio-only” in terms of modality and allow for coverage.147 the impact of covid-19 saw a greater implementation of making 141. creating opportunities now for necessary and effective care technologies (connect) for health act of 2021, h.r. 2903, 117th cong. (2021). see also brian schatz et al., connect for health act of 2021, u.s. sen. brian schatz hi, https://www.schatz.senate.gov/ imo/media/doc/connect%20for%20health%20act%20of%202021_summary.pdf [https://perma.cc/k63u-ru87] (last visited mar. 13, 2022); gina l. bertolini et al., connect for health act of 2021 reintroduced, nat’l l. rev. (june 22, 2021), https://www.natlawreview. com/article/connect-health-act-2021-reintroduced [https://perma.cc/8f8u-c59m]. 142. permanency for audio-only telehealth act, h.r. 3447, 117th cong. (2021). 143. protecting rural telehealth access act, s. 1988, 117th cong. (2021). 144. victoria bailey, gop, independent senators co-sponsor medicare telehealth access bill, xtelligent healthcare media (jan. 28, 2022), https://mhealthintelligence.com/news/gopindependent-senators-co-sponsor-medicare-telehealth-access-bill [https://perma.cc/4pju-b52h]. 145. see state telehealth laws and medicaid program policies, supra note 21 (“telehealth policy trends continue to vary from state-to-state, with no two states alike in how telehealth is defined, reimbursed or regulated.”). 146. s.b. 8416, 2019-2020 gen. assemb. (n.y. 2020). 147. id. 376 indiana health law review [vol. 19:351 audio-only telehealth available at the state level: the addition of telephone was one of the most common covid-19 temporary telehealth policy expansions, and twenty-two states are now reimbursing the modality permanently, although some only through specific audio-only or ctbs codes that include audio-only service delivery.148 in december 2021, the state of washington had regulations finalized through the office of the insurance commissioner to implement its audio-only law passed in may 2021 that required, among other things, reimbursement parity between audio-only telehealth and in-person visits ensuring equal rate of payment for audio-only telehealth encounters.149 massachusetts has also seen a substantial change in its definition of “telehealth” to include the audio-only modality passed in january 2021.150 while florida had been a state to prohibit the audio-only telehealth modality,151 it is now actively considering new legislation that would allow for its coverage as of january 2022.152 however, some states, such as mississippi, are pursuing bills that do continue to require both an audio-visual component for telehealth highlighting that telehealth access, especially involving the audio-only option, will potentially differ by location.153 b. addressing lack of broadband access it has become apparent, particularly during the pandemic, that one of the bigger problems in providing access to telehealth has to do with broadband internet access.154 because of this, greater attention is focusing on how legislation and policy can be used to expand access. however, despite the efforts being made as explored briefly below, the reality exists that infrastructure for 148. see state telehealth laws and medicaid program policies, supra note 21. 149. anuja vaidya, washington state solidifies audio-only telehealth regulations, xtelligent healthcare media (dec. 2, 2021), https://mhealthintelligence.com/news/ washington-state-solidifies-audio-only-telehealth-regulations [https://perma.cc/8wfz-flzb]. 150. nathaniel m. lacktman, new massachusetts telehealth law signed: top 3 changes, foley (jan. 19, 2021), https://www.foley.com/en/insights/publications/2021/01/massachusettstelehealth-law-signed-top-3-changes [https://perma.cc/r7q4-ftsy]. 151. fla. stat. § 456.47 (2021). 152. victoria bailey, florida senate passes bill allowing audio-only telehealth use, xtelligent healthcare media (jan. 31, 2022), https://mhealthintelligence.com/news/floridasenate-passes-bill-allowing-audio-only-telehealth-use [https://perma.cc/4xu9-e3at]. 153. s.b. 2738, 2022 reg. sess. (miss. 2022). see also maria andrade et al., executive summary: tracking telehealth changes state-by-state in response to covid-19 – april 2022 #2, jdsupra (apr. 25, 2022), https://www.jdsupra.com/legalnews/executive-summary-trackingtelehealth-6557454/ [https://perma.cc/h7cz-6z5s]. 154. katie palmer, as internet access limits telehealth’s reach, insurers are starting to cover the bill, stat (feb. 3, 2022), https://www.statnews.com/2022/02/03/telehealth-visits-healthinsurance-internet/ [https://perma.cc/a8ck-5z9d]. 2022] reconnecting the patient 377 implementing effective broadband across the country will necessitate both funding and time therefore, requiring that there must be other options in the meantime making options like audio-only telehealth an attractive option, even if only temporarily.155 1. federal the issue of broadband access is now viewed as a pressing need by the federal government as a result of the pandemic and given the amount of individuals across the u.s. lacking access to broadband internet even when difficult to fully assess as described earlier.156 most recently, the infrastructure investment and jobs act (“infrastructure act”) promises an infusion of millions of dollars from the federal government into states in order to provide greater access to broadband internet by requiring internet providers to offer broadband access to individuals with lower income.157 a similar tactic was tried at the state level with state legislation in the state of new york but received resistance to the point of judicial order restricting the ability to implement the law.158 despite this massive plan for implementation, this will take time and is not an overnight fix to the challenge of the digital divide in access to broadband internet. the federal government has also attempted to provide broadband access through programming run by the federal communications commission (“fcc”) known as the emergency broadband benefit (“ebe”).159 however, as of december 31, 2021, this was transitioned to different programming known as the affordable community program (“acp”).160 the increased funding for acp was provided through the infrastructure act.161 generally, the acp is designed to 155. id. 156. campbell et al., supra note 62 (“there is some disagreement as to the extent of underserved areas across the u.s. in its 2020 broadband deployment report, the fcc found that 18.3 million americans still lack access to broadband internet. however, the fcc’s census blocklevel broadband deployment map relies on self-reported data from internet service providers, and considers a census block ‘covered’ if as few as only one or two residences in the block are served. independent research by groups such as broadband now suggests the more accurate number is closer to 42 million americans.”). 157. james k. willcox, infrastructure law includes $65 billion for improving internet access, consumer rep., https://www.consumerreports.org/internet/infrastructure-bill-includes-65-billionfor-internet-access-a6861027212/ [https://perma.cc/p2h2-5tp6] (last updated nov. 15, 2021). 158. connor perrett, a federal judge has blocked a new york law requiring internet service providers offer $15 broadband to low-income residents, bus. insider afr. (june 12, 2021, 6:22 pm), https://www.businessinsider.com/judge-blocks-new-york-law-requiring-affordablebroadband-2021-6 [https://perma.cc/ju66-ayv5]. 159. emergency broadband benefit, fed. commc’n comm’n, https://www.fcc.gov/broadband benefit [https://perma.cc/9ck2-7lc2] (last updated mar. 15, 2022). 160. affordable connectivity program, fed. commc’n comm’n, https://www.fcc.gov/ affordable-connectivity-program [https://perma.cc/8j4z-j8ch] (last updated mar. 25, 2022). 161. id. 378 indiana health law review [vol. 19:351 provide broadband internet at a discounted rate to those otherwise unable to afford it.162 the final rules to implement the acp were adopted by the fcc on february 14, 2022.163 eligibility requirements must be met in order to qualify for the program164 based on income level (“a household is eligible for the affordable connectivity program if the household income is at or below 200% of the federal poverty guidelines”) or an individual in the household receives a form of the designated public benefits.165 the extent of what benefits are available to those who qualify for the acp are as provided: the benefit provides a discount of up to $30 per month toward internet service for eligible households and up to $75 per month for households on qualifying tribal lands. eligible households can also receive a onetime discount of up to $100 to purchase a laptop, desktop computer, or tablet from participating providers if they contribute more than $10 and less than $50 toward the purchase price. the affordable connectivity program is limited to one monthly service discount and one device discount per household.166 the impact of the acp, however, will take as long as 10 years.167 in may 2022, the white house announced plans to jointly work with numerous internet providers to now cap the cost for broadband internet under the acp with the goal of providing this access to approximately 48 million qualifying households.168 in the meantime, states may be left filling in the gaps as many have been actively seeking legislative solutions to increasing broadband access as discussed below. 2. state at the state level, there has been a lot of legislative activity surrounding increasing access to broadband internet.169 the national conference of state legislatures (“ncsl”) has monitored the extent of pending state legislation involving broadband internet which has dramatically increased in 2021: in the 162. id. 163. affordable connectivity program; emergency broadband benefit program, 87 fed. reg. 8346 (feb. 14, 2022). 164. affordable connectivity program, supra note 160. 165. id. 166. id. 167. campbell et al., supra note 62. 168. ayana archie, the biden administration is capping the cost of internet for low-income americans, nat’l pub. radio (may 9, 2022, 5:01 am), https://www.npr.org/2022/05/09/ 1097535349/biden-administration-internet-wifi-low-income-medicaid-snap-verizon-comcast [https://perma.cc/kl7f-v36p]. 169. heather morton, broadband 2021 legislation, nat’l conf. st. legislations (jan. 7, 2022), https://www.ncsl.org/research/telecommunications-and-information-technology/broadband2021-legislation.aspx [https://perma.cc/d3lx-yq9t]. 2022] reconnecting the patient 379 2021 legislative session, 48 states, the district of columbia and puerto rico had pending legislation addressing broadband in issue areas such as educational institutions and schools, dig once, funding, governance authorities and commissions, infrastructure, municipal-run broadband networks, rural and underserved communities, smart communities and taxes.170 of these areas of pending legislation, the majority of bills involve rural and underserved populations (288).171 further, there have been many states with pending legislation regarding infrastructure (188).172 aside from this, there have been successes at the state level in either passing legislation or resolution.173 specifically, a number of states have taken actual legislative actions: forty jurisdictions enacted legislation or adopted resolutions: alabama, arizona, arkansas, colorado, california, connecticut, florida, hawaii, idaho, illinois, indiana, iowa, kentucky, louisiana, maine, maryland, massachusetts, minnesota, mississippi, montana, nebraska, nevada, new hampshire, new jersey, new mexico, new york, north carolina, ohio, oklahoma, oregon, pennsylvania, puerto rico, south dakota, texas, utah, vermont, virginia, washington, west virginia and wyoming.174 despite these advances, broadband internet access continues to be a major factor in securing telehealth services. c. digital literacy a related issue to broadband internet access is digital literacy, although this extends more broadly to the use not only of the internet but of technology more generally, including the use of devices. in many ways as equally as important as having the necessary technology, digital literacy has not yet received as significant attention when it has come to legislative solutions. at the federal level, a new bill introduced in january 2022 known as the digital literacy and equity commission act was in response to the infrastructure law aiming to evaluate digital literacy in the u.s. including the creation of a digital literacy commission.175 an overview of the bill is described as follows: the digital literacy and equity commission would be chaired by the secretary of education and the chair of the federal communications commission. this legislation would require the commission to submit a report to congress that contains recommendations on how to improve and maintain the digital and information literacy of individuals in the united states. in particular, this commission would be tasked with 170. id. 171. id. 172. id. 173. id. 174. id. 175. h.r. 6373, 117th cong., 1st sess. (2022). 380 indiana health law review [vol. 19:351 addressing low-income and disadvantaged areas. the final report will include strategies to improve digital literacy through early education and community outreach.176 the state level has also been slow in legislative progress on the digital literacy issue. according to the ncsl 2021 review, only twelve states had pending legislation regarding digital literacy.177 one example of this pending legislation is found in the state of massachusetts in sb 678, an act relative to telehealth and digital equity for patients.178 the massachusetts medical society explained the benefit of this legislation in terms of digital literacy as follows: the centerpiece of this legislation directs the health policy commission (hpc) to establish two pilot programs – a digital bridge pilot program and a digital health navigator tech literacy pilot program—to support expanded access to telehealth technologies and technological literacy for patients. the digital bridge program aims to increase access to telehealth services through investments in telecommunications services, broadband and internet connectivity services, and digital technology. the tech literacy program directs hpc to engage with community health workers and other professionals who can act as telehealth navigators for underserved and elderly populations who may need greater assistance in accessing telehealth services. another important equitable measure contained in this legislation requires insurers to cover interpreter services for patients with limited english proficiency and for those who are deaf or hard of hearing. with increased utilization of telehealth comes the opportunity to reduce racial, socio-economic, and other inequities in access to care and health outcomes, but only if we are intentional about building policies that identify and address barriers to accessing care via telehealth for communities that have historically faced traditional barriers to in-person care.179 having the technology but a lack of individuals’ knowledge in terms of how to actually utilize the technology will not improve access to telehealth, particularly among populations with existing healthcare disparities. 176. press release, u.s. rep. brenda lawrence, u.s. rep. lawrence introduces new legislation to increase digital literacy (jan. 12, 2022), https://lawrence.house.gov/mediacenter/press-releases/us-rep-lawrence-introduces-new-legislation-increase-digital-literacy [https://perma.cc/446g-zl4p]. 177. morton, supra note 169. 178. s.b. 678, 162nd gen. assemb. (mass. 2021). 179. see testimony in support of h.1101/s/678, an act relative to telehealth and digital equity for patients before the joint committee on financial services, mass. med. soc’y (july 1, 2021), https://www.massmed.org/advocacy/state-advocacy/state-testimony/testimony-insupport-of-h-1101-and-s-678,-ac-act-relative-to-telehealth-and-digital-equity-for-patientsbefore-the-joint-committee-on-financial-services-(pdf)/ [https://perma.cc/y4a5-zy35]. 2022] reconnecting the patient 381 d. addressing the distinct needs of various groups another area that there has been some legislative movement has been legislation that has been designed to address some of the unique needs of various groups including non-english speakers and individuals with disabilities. for example, massachusetts proposed a bill that would have enabled non-english speakers to have access to translation services and those who are deaf or hard-ofhearing through reimbursement in sb 678, an act relative to telehealth and digital equity for patients.180 another example of this has been seen in a bill in new jersey specific to needs of individuals with disabilities with a5255 which is designed to provide telehealth access by requiring communication features to serve various disabilities.181 such legislation is not only critical to ensuring equal access to telehealth but inevitably, healthcare equity. in a broader legislative effort, a bill called the health equity and accountability act has been reintroduced at the federal level to address healthcare inequity to include these groups and others in a number of ways that extends to access to telehealth.182 v. recommendations for policy solutions to address the digital divide going forward given the exploration of the impact of the digital divide and its potential to further alienate particular populations from access to telehealth, policymakers must be mindful of the importance of crafting policy solutions that attempt to bridge this divide that will only widen existing healthcare disparities if left unaddressed as telehealth becomes a more regular option in healthcare delivery in the u.s. the following recommendations are intended to help bridge this divide. a. allowing coverage for various modalities of telehealth telehealth policy must consider the availability, usefulness, and efficacy of different telehealth modalities (i.e., audio-only). for example, while there was initially ambivalence to the use of the audio-only telehealth modality, research has already shown that this modality was a lifeline for many vulnerable populations discussed in this article, particularly, those who are lacking access to various technologies including broadband internet or devices such as smartphones. even if coverage for audio-only should be limited (i.e., only allowing a particular number of audio-only telehealth encounters in a given period of time) to avoid concerns of fraud and abuse or simply overutilization that would drive up healthcare costs and possibly also result in harm to patient care by overreliance, it has even been suggested the option at least be made temporarily at a minimum to allow for audio-only telehealth (i.e., fqhcs). this 180. mass. s.b. 678. 181. a.b. 5255, 219th legislature (n.j. 2021). 182. h.r. 7585, 117th cong. (2022). 382 indiana health law review [vol. 19:351 would be the favorable option based on current research until further research can otherwise ascertain the extent to which the modality is beneficial or problematic to instruct the extent of its use more permanently. telehealth research generally is still being conducted to inform policy resulting largely in policy solutions with greater flexibility to respond to these research developments. however, access must consider the current reality of the situations of different populations’ needs, especially those lacking technology options. because audio-only telehealth is available does not mean it is appropriate in all medication situations nor will it be an option for every patient, but it will, in the least, help many who can use it in the current gap of technology access as it did during the pandemic. it also may continue to be useful beyond this gap permanently for various medically appropriate situations as determined by continued research and for those patients who could still benefit from its availability where other technology is not useful for or desirable by the patient. b. affordability of technology while it is known that affordability has been, and will continue to be, an issue going forward, and even more so due to the financial impact of the pandemic, there needs to be greater attention from a policymaking standpoint as to making affordability a key consideration. although there have been substantial efforts to limit or decrease the cost of broadband internet access, this is only a part of the puzzle. if assistance programs are only “temporary”, they will not solve the problem long-term when the funding expires. aside from the broadband internet access, there has been minimal attention to affordability regarding the other technologies including smartphones, ipads, and laptops from a policy standpoint. the biggest attempt to provide assistance here by the federal government has been the acp program but the one-time benefit of $100 towards a technology device that will merely make a dent in such expenses. “for example, on average, the cost of a new laptop is between $600-$750.”183 this does not even take into account the possibility that at some point, the device may need repair after manufacturer warranty has expired. in order to fully engage in the traditional telehealth modality involving both audio and visual components, the technology involved would include both the broadband internet as well as the actual device to be utilized. the majority of those who cannot afford broadband internet are also likely unable to afford the devices needed in order to use the audio-visual telehealth modality. if that modality is the primary telehealth offered and these devices also continue to be unaffordable to particular populations, there will continue to be the growth of the digital divide. another option would be having certain government offices (i.e., those serving this populations’ health departments) having rental programs for devices for nominal fees and/or providing the technology at places that would be easily accessible to these populations such as libraries and community centers where healthcare can and 183. how much should you spend on a laptop in 2022?, leaguefeed (dec. 12, 2021), https://leaguefeed.net/how-much-should-you-spend-on-laptop/ [https://perma.cc/y53k-rarb]. 2022] reconnecting the patient 383 will also be viewed as a central part of life. thus, affordability must be at the forefront of policy solutions to prevent deepening the digital divide. c. accessibility in usability: education & design as previously discussed, having the technology to be able to access telehealth is not in itself sufficient. there are two additional significant issues that relate to the technology that must be addressed: 1) digital literacy—the capability to actually know how to use the technology and education if the person or persons lack this, and 2) design—that the technology is created in such ways as to accommodate the distinct needs of different populations rather than a one-sizefits-all approach. policy solutions must appropriately address both areas. education may include having training available in public places (i.e., libraries, senior centers, community centers) where individuals can be trained in how to use the technologies to access telehealth and ensuring people know where to get this training. additionally, if the technologies themselves are not designed and tailored to the various needs of the populations discussed, these will remain inaccessible to these groups only contributing to the digital divide. policy solutions must either offer incentives for ensuring that design takes into account the needs of various populations (i.e., such as non-english speakers or those with cognitive disabilities) or otherwise promote ensuring that design takes into account these groups. d. further research to inform policymaking it is known that the expansive use of telehealth remains in its infancy. data is just starting to be collected and more fully explored in terms of the use of telehealth that occurred at its peak during the pandemic. even some of the data that has been collected is insufficient, for example, in distinguishing video visits from audio-only telehealth encounter: the postpandemic literature must also be interpreted with caution. many studies fail to distinguish audio-only from video-enabled telemedicine encounters, leaving unanswered a key equity question regarding the appropriateness and value of audio-only encounters.184 further, data particular to the clinical appropriateness of the use of telehealth continues to be lacking (in other words, when it is medically appropriate to be using telehealth).185 equity must also consider more than just the individual: “many studies have explored only patient-level barriers or factors associated with telemedicine use. however, equity is affected by barriers at the family, community, or health care delivery level.”186 184. see khoong, supra note 35. 185. andis robeznieks, can 10 months of data show how to optimize use of telehealth?, ama (feb. 12, 2021), https://www.ama-assn.org/practice-management/digital/can-10-months-datashow-how-optimize-use-telehealth [https://perma.cc/77na-7x9y]. 186. see khoong, supra note 35. 384 indiana health law review [vol. 19:351 cost has been a frequent point of discussion in terms of telehealth moving forward. however, this is another area that lacks adequate research that will and should continue to inform future policymaking. one attempt to begin to bridge this gap is seen in h.r.1406 covid–19 emergency telehealth impact reporting act of 2021 to examine impact of telehealth use involving medicare.187 e. a holistic approach to telehealth—and its policy generally, up to this point, telehealth has often been viewed or observed in vary narrow terms that has not fully captured the extent of the issues. as meg barron, ama’s vice president of digital health innovations stated: “mostly, people have been looking at telehealth from the perspective of financial outcomes, rather than looking at it holistically and from the perspective of other value streams such as health equity, patient access, physician and patient experience, and—most importantly—clinical outcomes, barron said.”188 until telehealth’s impact is more fully explored from all of these different angles, policy solutions will fall short, particularly, in effectively ensuring that the populations discussed in this article will not be left behind. additionally, thinking about telehealth in terms of person-centered care means that different telehealth encounters will work better or worse for different individuals and different clinical situations: “a patient-centered perspective recognizes that the value of telemedicine varies for each patient and each clinical concerns.”189 this impact of the digital divide has not been acknowledged to its fullest extent domestically, but globally the un, which has put forth a platform for addressing the digital divide, that emphasizes four areas: access, affordability, skills, and awareness/relevance of online content.190 u.s. policy solutions would similarly benefit from exploring and embracing, as appropriate, these same key areas of focus moving forward. vi. conclusion the digital divide was magnified by the occurrence of the covid-19 pandemic and the instantaneous reliance on digital access in order to receive a number of basic necessities, including healthcare, through the massive overnight transformation of providing healthcare delivery through telehealth that occurred throughout the u.s. the use of telehealth to supplement, and not replace, regular delivery of healthcare is considered revolutionary which likewise means that the policy response must match to this dramatic alteration of the healthcare delivery landscape--and also be revolutionary. 187. covid–19 emergency telehealth impact reporting act of 2021, h.r. 1406, 117th cong. (2021). 188. robeznieks, supra note 185. 189. see khoong, supra note 35. 190. leveraging digital technologies for social inclusion, united nations dep’t econ. & soc. aff. (feb. 18, 2021), https://www.un.org/development/desa/dspd/2021/02/digital-technologiesfor-social-inclusion/ [https://perma.cc/e78n-pqe7]. 2022] reconnecting the patient 385 but what exactly is “revolutionary” when it comes to these policy solutions? often, policy solutions create one-size-fits-all approaches that only accommodate a particular group. if we truly believe that everyone should have access to healthcare in all its delivery forms, then our approach to the use of telehealth and the policies regulating it cannot continue the traditional route of only considering the haves and not the have nots or those with particular needs that are “different.” the entire point of technology is “connection” but if that connection is only accessible by a particular group, we are again choosing to essentially promote healthcare access for some but not all, particularly not those whose needs are different from this select, and arguably, elite group who have technologies, know how to use them, and have no specific needs that would prevent them from utilizing the technologies. that cannot be neither our goal of healthcare generally, nor of telehealth as a means of healthcare delivery specifically. ultimately, we are also making a value judgment through all of this about whose healthcare matters in this transition to healthcare delivered by technology and our response. it should not be only those who have access to technology without challenge and thus, the availability of telehealth, whose healthcare matters. telehealth, when used appropriately, can be of tremendous value to healthcare delivery and even more so, for these various groups—the elderly, minority groups, those in low socioeconomic status, those in rural areas, the disabled, non-english speakers, and children—but only when the digital divide is tackled appropriately with unique policy solutions that truly address the issues involved—not just select issues. technology is ultimately meant to provide connection, but if these groups remain essentially disconnected, the digital divide will deepen. reconnecting the patient requires crafting policy solutions that truly and adequately bridge that divide rather than cherry picking a particular issue that only solves part of the problem. telehealth can and should thrive for all creating greater access to healthcare – let’s revolutionize the policy solutions that fully address the digital divide to do so. instead of the digital divide, we must become the “digital provide” – providing access in all respects that allows every person the fullest access to healthcare also through technology and the implementation of policies and regulations that ensure this connection while maintaining the appropriate clinical delivery of healthcare. indiana health law review volume xxi 2024 number 1 notes incentivizing drug affordability: wildcard exclusivity vouchers thomas abrams* i. introduction the cost of medicine frustrates most of society—especially patients, lawmakers, and scientists—and will continue to frustrate far into the future. inventing a chemical or biologic capable of improving or saving life is not cheap, to be sure. risky private investment is incentivized by the windfall potential created by patents and monopoly prices. monopoly prices, among other factors outside the scope of this note, contribute to the inability of many patients to afford and access medically necessary treatments. when patents expire, generic substitutes drive down prices. however, generic access can be unnecessarily delayed when monopolies persist beyond patent expiration. when generic availability is inappropriately delayed, patients and society are left paying gratuitous multiples of the break-even cost of their medicine, long after inventors have recouped their initial investment and turned a profit. ii. background & overview to appreciate how reduced generic access translates to higher costs and poorer health outcomes, one must understand the relationship between innovators and generic manufacturers. this understanding can then be applied to examine price-lowering policies. rather than “pushing” low prices with more expensive red tape, new policies should “pull” prices lower by incentivizing price-lowering behavior. the stick is exhausted, and modern policies should explore the carrot. a. innovative versus generic medicine innovator pharmaceutical companies and generic pharmaceutical companies appear similar at first glance. indeed, the food and drug administration (“fda”) requires generic medicine to be manufactured with the same (1) active/key ingredient, (2) strength, (3) dosage form (e.g., tablet, capsule, liquid), and (4) * j.d. candidate, 2024, indiana university robert h. mckinney school of law; b.s., 2021, university of dayton. a special thank you to kurt karst, professor aila hoss, jake butz, and ihlr colleagues for inspiring and supporting this note. 122 indiana health law review [vol. 21:121 route of administration (e.g., oral, topical, injectable) as the brand-name.1 the innovator/brand-name and generic sectors are differentiated less by the substance of their drugs and more by their business models, strategies, operations, goals, and challenges. innovators invent and patent medicines, which are marketed exclusively by the patent holder during the patent(s) life. generic firms target weak patents or off-patent drugs, copy the formula, and sell a “generic” form of the innovator’s medicine at a discount. thus, patent expiration or invalidation results in competition, lower prices, and higher access as generics and innovators market interchangeable products to the same patients. although generics rely on innovators to invent the next product, short-term success can be mutually exclusive when the two share a market. as innovators’ patents age, generic suitor(s) prepare to launch—which may be done “at-risk” (i.e., before the innovator’s patent expires) if the generic firm believes a patent is invalid—a discounted, interchangeable version of the original drug. at this stage, the hatch-waxman process (to be discussed) for generic entry draws the parties into negotiations. sometimes, and particularly beneficial to patients struggling with affordability, the parties enter a settlement to allow generic entry prior to patent expiration. in its study of generic entry prior to patent expiration, the federal trade commission (“ftc”) identified that “in 7 of the 20 final settlements, the brandname company granted a license to the generic applicant to use the patents that cover the brand-name drug product prior to patent expiration so that the generic applicant could market under its [abbreviated new drug application]” (“anda”).2 another ftc study showed opposite outcomes, where among 218 settlement agreements, “66 final agreements involved some form of compensation from the brand to the generic combined with a delay in generic entry.”3 while not in the majority, these 66 agreements represent “pay-for-delay”—a concerning tactic leveraged by some patent holders to delay generic competition and prop up monopolies.4 as a result, patients “miss out on generic prices that can be as much as 90% less than brand prices. for example, brand-name medication that costs $300 per month might be sold as a generic for as little as $30 per month.”5 regardless of who (e.g., patient, insurer, taxpayer, public program) pays what “price” (e.g., copays, insurance premiums, list price), the difference between brand and generic price is not small. 1. u.s. food & drug admin., generic drugs: overview and basics (2017), https://www.fda.gov/drugs/generic-drugs/overview-basics [https://perma.cc/zf5n-n948]. 2. u.s. fed. trade comm’n, generic drug entry prior to patent expiration: an ftc study, 25 (2002), https://www.ftc.gov/reports/generic-drug-entry-prior-patent-expiration-ftc-study [https://perma.cc/j5v9-9x8r]. 3. u.s. fed. trade comm’n, pay-for-delay: how drug company pay-offs cost consumers billions, 4 (2010), https://www.ftc.gov/reports/pay-delay-how-drug-company-pay-offs-costconsumers-billions-federal-trade-commission-staff-study [https://perma.cc/mz9e-dxr2]. 4. id. 5. id. at 1. 2024] incentivizing drug affordability 123 b. the problem: price & health outcomes the consequence of poor generic access is not just monetary. in the u.s., 8% of adults report worsening health conditions correlated with their inability to afford prescriptions.6 according to the kaiser family foundation, 29% of u.s. adults forego medicine because of the cost. nearly 30% of americans are skipping doses, cutting pills in half, or not filling prescriptions because of the cost.7 approximately 8% of u.s. adults reported worsening health after skipping medication.8 the figure below illustrates where affordability concerns are especially potent. figure 19 c. roadmap although approaches to delay generic entry vary in form, this note uses “pay-for-delay” to refer to the various forms collectively. this note explains the problem of pay-for-delay and the difficulty of solving it before proposing a lowfriction incentive program as a solution. by presenting attractive alternatives to companies that would otherwise extend monopolies, a “wildcard exclusivity” 6. kaiser fam. found., poll: nearly 1 in 4 americans taking prescription drugs say it’s difficult to afford their medicines, including larger shares among those with health issues, with low incomes and nearing medicare age (mar. 2019), https://www.kff.org/health-costs/pressrelease/poll-nearly-1-in-4-americans-taking-prescription-drugs-say-its-difficult-to-affordmedicines-including-larger-shares-with-low-incomes/ [https://perma.cc/bsu2-a3rb]. 7. id. 8. id. 9. id. 124 indiana health law review [vol. 21:121 system would simultaneously reward companies that facilitate drug affordability, save patient and public dollars, and improve health outcomes. this note embraces one promising incentive, but other incentives outside the scope of this note—such as fda user fee waivers and tax credits—could be incorporated into a more dynamic incentive package. each year, pay-for-delay saddles the u.s. healthcare system with billions of dollars in avoidable cost.10 the most conservative estimated annual burden is $3.5 billion while more inclusive estimates exceed $37 billion.11 based on six different methodologies, a study by robin feldman calculated an average burden of $19.2 billion, or about 7% of average annual u.s. drug spending.12 in deriving these empirical estimates, feldman analyzed historical pay-for-delay settlements and determined the length of delay.13 then, the eventual generic price—what consumers would have paid but for the pay-for-delay settlement—was subtracted from the former monopoly price.14 “this revealed the cost incurred by consumers as a result of the improper extension of the brand’s monopoly.”15 essentially, the “burden” refers to the difference between an inappropriately preserved monopoly price and the discounted generic price that society would enjoy but for pay-fordelay. the portfolio of attempts—historic and proposed—to reach the pay-for-delay angle of drug affordability consists largely of nominal progress and defeat. in part, this is due to a plethora of legally defensible practices that, with the right spin, circumvent existing policy. owing to this environment and respecting the objectives of all stakeholders, this note explores two low-friction, nonpunitive incentive structures: (1) the fda’s priority review voucher program (“prv”), and (2) wildcard exclusivity vouchers (“wildcard”). the proposed prv incentive would reward innovator companies that choose to facilitate price reductions rather than delay generic entry. specifically, the fda would issue prvs to firms that facilitate generic entry or otherwise facilitate price reductions. such a program would reduce drug prices, improve patient access to medicine, and catalyze competition within the pharmaceutical industry, all while respecting the economic and capitalistic interests of innovator companies. unfortunately, the prv proposal gives way to economic and efficiency concerns. fortunately, the wildcard proposal is unthreatened by those concerns affecting the prv proposal. offering a transferable market exclusivity voucher—a wildcard—to firms that invite generic competition or unilaterally decrease prices can induce lower, propatient pricing and grow generic competition while rewarding innovators. this note proposes that congress, through an amendment to the food drug and 10. robin c. feldman, the price tag of “pay-for-delay”, 23 colum. sci. & tech. l. rev. 1, 32-33 (2022), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3846484 [https://perma.cc/ 5ftm-jdzq]. 11. id. 12. id. 13. id. at 17. 14. id. 15. id. 2024] incentivizing drug affordability 125 cosmetic act (“fdca”), introduce a carefully tempered wildcard exclusivity incentive program. this note first describes the characteristics and differences between two important industry participants, generic companies and innovator companies, to reveal the fundamental conflict between the two groups. next, the hatchwaxman act is discussed to illustrate the process of bringing a generic drug to market and to introduce the issue of delaying generic entry, or “pay-fordelay.” the classic form of pay-for-delay—the reverse payment settlement agreement—is described and later expounded upon by a discussion of ftc v. actavis, wherein the supreme court addressed reverse payment settlement agreements. the increasingly nuanced forms of delaying generic entry which emerged in the wake of actavis are then described, leading into analysis of existing and proposed enforcement mechanisms and why these often fail. the novel incentive program at the heart of this note is then introduced and analyzed with a discussion of why it is advantageous relative to other proposals. this note concludes by summarizing the advantages of the proposed wildcard incentive, and how patients and the u.s. healthcare system can benefit through its adoption. iii. industry participants for the purposes of this note, drug industry participants can be divided into innovator companies and generic companies. both create value for patients and the healthcare system in different ways. despite sharing a market and selling an interchangeable product, they lack operational and strategic similarities and face different challenges. in the high-stakes world of pharmaceuticals, generics and innovators often clash and become distracted from their societal value propositions (the value proposition of an innovator could be inventing medicine, while that of a generic could be lowering the price medicine). when innovators and generics clash and stray far from their purposes, patients and payors are caught in the crossfire and suffer from higher prices and stifled access. a. innovator companies the first group to discuss is innovator companies, or companies that invest in research and development to invent, patent, and bring to market new medicines under the company’s brand name. familiar names falling into this “innovator” category include abbvie, merck & co., bristol myers squibb, and a host of others. although this note concerns private innovators, the indispensable role of public contributions cannot go uncredited. the national institutes of health (“nih”) contributed over $100 billion dollars in grant funding to research associated with all 210 drugs approved by the fda between 2010–2016.16 by building the early foundations in various treatment areas, publicly funded 16. ekaterina galkina cleary et al., contribution of nih funding to new drug approvals 2010-2016, proceedings of the nat’l acad. of sci. (2018), https://pubmed.ncbi.nlm.nih. gov/29440428/ [https://perma.cc/6lps-rrx3]. 126 indiana health law review [vol. 21:121 discoveries often precede and inspire eventual private sponsorship of related drug development programs.17 in the private sector’s quest for new medicine, innovators attempt to invent, patent, and steer new medicines from labs to patients. with fda approval, innovators can market their invention as a prescription drug under its brand name. because new drugs are protected by patents, their inventors are entitled to a legal monopoly on the drug.18 patents are usually filed early in the development process, allowing much of the patent’s exclusivity period to lapse while the drug is still in the lab, clinical trials, or fda review processes. therefore, despite patents entitling the inventor to twenty years of protection, most drugs reach the market with only seven to ten years of patent life remaining.19 factoring in capital costs and expenditures on drugs that fail to reach the market—only 12% of drugs entering clinical trials ultimately reach the market—the cost of successfully developing one new drug can eclipse one or two billion dollars.20 once costs and risks are overcome and a new drug is marketed, its inventors benefit from a monopoly for the remainder of the patent life. as patents approach expiration, the other group of industry participants relevant to this note enters the equation—generic companies. b. generic companies rather than inventing medicine, generic companies serve a different function—price control through competition. examples of popular generic companies include teva, viatris, dr. reddy’s, and fresenius kabi. when patents on the innovator’s medicine expire, generic companies replicate the formula, seek fda approval, and sell approved generic versions of brand-name drugs at significant discounts. unburdened by the level of research and development expense shouldered by innovator companies, generic companies can survive on small profit margins—this dynamic allows generic companies to sell drugs at large discounts. the first generic usually enters the brand name product’s market at a discount of approximately 20%.21 as more competitors enter the post-patent market, the generic discount against the brand price grows to 85%, on average.22 by offering 17. id. 18. f.t.c. v. actavis, inc., 570 u.s. 136, 148 (2013). 19. jan berger et al., how drug life-cycle management patent strategies may impact formulary management, 22 am. j. manag. care s487, s489 (2016), https://pubmed.ncbi.nlm. nih.gov/28719222/ [https://perma.cc/2dbv-256p]. 20. cong. budget off., 57025, research and development in the pharmaceutical industry 2, 14, 17 (apr. 2021), https://www.cbo.gov/publication/57126 [https://perma.cc/m4t3lt72]. 21. robin feldman & evan frondorf, drug wars: a new generation of generic pharmaceutical delay, 53 harv. j. legis. 499, 500-501 (2016), https://papers.ssrn.com/sol3/ papers.cfm?abstract_id=2659308# [https://perma.cc/5d83-agth]. 22. u.s. food & drug admin., generic drug facts, https://www.fda.gov/drugs/generic2024] incentivizing drug affordability 127 lower prices and making medicine more affordable, generic drug makers create savings and increase access to medicine. more than 10,000 generic drugs have been approved, accounting for 90% of prescriptions filled in the united states.23 despite nine out of ten prescriptions being filled by generic drugs, generics are only responsible for 18% of drug spending—a testament to the ability of generics to save money (i.e., 90% of volume, but only 18% of cost).24 in 2020, generics were responsible for $338 billion in savings.25 by avoiding the risk and cost of developing new medicine, generics offer the same benefit at a reduced priced, saving the healthcare system billions of dollars annually. c. recap: innovators & generics innovator and generic companies each create essential value in different ways. innovators create new medicines, while generic companies make those medicines cheaper and more accessible. when generics enter the market, innovators lose pricing power and sales volume. therefore, it is often in the innovator’s best interest to delay generic competition. delaying generic entry is a way to maximize profits and fund new inventions. sometimes delaying generic entry is the difference between solvency and bankruptcy for a firm with one or few marketable products. however, if financial health is achievable through more certain means, the utility of pay-for-delay as a business strategy is reduced. much like a bird in the hand that is worth more than two in the bush, the certainty of a valuable wildcard on the balance sheet can outweigh the pursuit of future monopoly sales, the value of which must be discounted by the uncertainty, cost of litigation, and potential for antitrust liability. iv. hatch-waxman & pay-for-delay in 1984, congress enacted the drug price competition and patent term restoration act, better known as the hatch-waxman act.26 hatch-waxman increased drug affordability by adding efficiency to the process by which generic drugs enter the market.27 prior to hatch-waxman, 19% of prescriptions were filled with generic drugs and 35% of top-selling drugs faced generic competition following patent expirations.28 today, 90% of prescriptions are filled with generic drugs/generic-drug-facts [https://perma.cc/2xna-7wtz] (last updated nov. 2021). 23. u.s. food & drug admin., office of generic drugs: 2021 annual report 2, 9 (2022), https://www.fda.gov/drugs/generic-drugs/office-generic-drugs-2021-annual-report [https://perma.cc/7wkg-4byc]. 24. id. at 2. 25. id. 26. 21 u.s.c. § 355 (2022). 27. what is hatch-waxman, phrma (2018), https://phrma.org/resource-center/topics/costand-value/what-is-hatch-waxman [https://perma.cc/u7lh-5gsj]. 28. id. https://perma.cc/u7lh-5gsj 128 indiana health law review [vol. 21:121 drugs and over 80% of brand drugs face generic competition.29 hatch-waxman achieved these improvements by increasing the efficiency and profitability of bringing a generic to market. previously, the use of patented inventions to develop drugs, even if not marketed, constituted infringement.30 because generic development and approval processes require years of work, this outdated treatment of generic development effectively extended patent protections. hatch-waxman changed this, stating “it shall not be an act of infringement” to use a patented invention in the development and submission of information under federal drug law. 31 this efficiency, with others including the abbreviated new drug application,32 ease and expedite generic competition. regarding profitability, hatch-waxman incentivizes generic competition by rewarding the first company to offer a generic alternative to an existing drug with a 180-day exclusivity period.33 this exclusivity period increases generic profitability by allowing the generic to compete with the brand company alone for 180 days, rather than competing with other generic competitors in addition to the brand company. in other words, the fastest generic company gets to go oneon-one with the brand company for six months before more generic competition enters the market. acutely designed to affect pressure points within the market, hatch-waxman brought about greater savings and greater access for patients. competition increased while prices fell.34 between 2009 and 2019, generic drugs were estimated to save the u.s. healthcare system over two trillion dollars.35 nevertheless, billions in would-be hatch-waxman savings go unrealized as some companies avoid generic pressure and maintain monopoly-level prices.36 patentees (patent holders) may anticipate the impending consequences of patent expiration and stall generic entry with a variety of legal maneuvers. the “reverse payment settlement agreement”—under anti-competitive circumstances—is the original form of pay-for-delay and an unintended byproduct of the hatchwaxman model. anti-competitive reverse payment settlement agreements remain emblematic of “pay-for-delay,” but the phrase has evolved into a more general reference to the tactical delay of competition. a. hatch-waxman’s abbreviated new drug application pathway hatch-waxman promotes competition by helping generic manufacturers reach the market faster through abbreviated new drug applications 29. id. 30. roche prod., inc. v. bolar pharm. co., 733 f.2d 858 (fed. cir. 1984). 31. 35 u.s.c. § 271(e)(1). 32. 21 u.s.c. § 355(j) (2022). 33. id. 34. feldman & frondorf, supra note 21, at 500-03. 35. generic drug facts, supra note 22. 36. feldman, supra note 10, at 32. 2024] incentivizing drug affordability 129 (“anda”).37 andas may be submitted by a generic regardless of an innovator’s patent protection through a “paragraph iv certification” in which the generic asserts that existing patents are either invalid or would not be infringed by the generic product.38 this allows generic companies to begin developing generic alternatives before the innovator’s patents expire. when a paragraph iv certification is filed, the certifying generic company must notify the implicated brand-name company within 20 days of filing the certification.39 after receiving notice of the paragraph iv certification asserting the invalidity or non-infringement of the patent-holding, brand-name company’s patent(s), the brand-name company initiates a lawsuit against the generic company for patent infringement. this infringement right of action is preemptive in nature, granted to brand-name companies even though the alleged infringement is yet to occur, and damages are still prospective.40 by allowing the generic firm to provoke the brand firm into litigation before the generic actually commits any alleged infringement, both parties benefit from greater efficiency and predictability. the filing of the lawsuit by the plaintiff-innovator against the defendantgeneric in response to the paragraph iv certification triggers a “stay period,” during which time the fda will suspend review of the anda for 30 months or until litigation is resolved.41 at this juncture, the innovator can either (1) litigate and attempt to uphold the patent in court, or (2) settle the lawsuit by paying (or otherwise compensating) the generic to delay launching its product until a later specified date. the second option is a “reverse payment settlement agreement.” many reverse payment settlements are entered in good faith and produce positive effects (e.g., a date certain for generic entry, eliminated litigation costs, reduced uncertainty). unfortunately, reverse payment settlements are also ripe for anticompetitive abuse. the complicated nature of pay-for-delay and the diversity of approaches make it difficult for the ftc—the agency tasked with rooting out anti-competitive conduct—to identify, let alone prove, true pay-for-delay schemes. b. secondary patents secondary patents rather than primary patents are the usual subject of paragraph iv certifications. further, many pharmaceuticals are protected by multiple patents. when multiple patents concern the same drug, the patents are often differentiated as “primary” or “secondary.” primary patents protect the “active ingredient,” or the invented chemical that is primarily responsible for a medication’s effect.42 primary patents are usually 37. 21 u.s.c. § 355 (j) (2022). 38. id. §§ 355(j)(2)(a)(vii)(iv). 39. id. §§ 355(j)(2)(b)(ii). 40. id. §§ 355 (j)(5)(b)(iii). 41. feldman & frondorf, supra note 21, at 509. 42. kevin t. richards et al., cong. rsch. serv., r46221, drug pricing and 130 indiana health law review [vol. 21:121 stronger and therefore not implicated in paragraph iv certifications. secondary patents do not protect the main invention but protect other aspects of the medicine including dosage (e.g., five milligrams per kilogram of body weight), form of administration (e.g., intravenous or “iv,” pill form, capsule), method of use (e.g., used to treat a specific form of cancer), manufacturing processes, or other nonprimary characteristics. for example, assume chemical x is the active ingredient in drug a, which effectively treats breast cancer when administered intravenously at five mg/kg. the inventor invented chemical x, but also discovered that chemical x has a therapeutic effect on breast cancer, can be administered effectively through an intravenous solution, and is effective therapeutically at a five mg/kg dose. chemical x is protected by a primary patent, while drug a’s application to breast cancer, intravenous administration technique, and effective dosage of five mg/kg are protected by secondary patents. the primary and secondary patents protect different features of the same drug and are usually filed at different times, creating multiple, staggered layers of patent protection. according to an ftc study, generic challengers win 73% of paragraph iv cases that are litigated to completion.43 however, the majority of paragraph iv cases settle with no conclusion regarding the patent’s true validity.44 patents implicated by paragraph iv certifications tend to be secondary patents,45 often vulnerable to invalidation.46 innovators/patentees recognize this risk and prospective loss of monopoly power. as a solution, patentees defending a weak secondary patent may wish to settle. by settling, the inventor seals off the dispute and saves its patent from potential invalidation. c. reverse payment settlement agreements rather than engage in drawn-out, expensive litigation with a fair chance of patent invalidation and loss of market exclusivity, the plaintiff-innovator/patentee may propose a mutually beneficial settlement in the form of a reverse payment settlement agreement. as previously mentioned, a reverse payment settlement essentially involves the plaintiff-innovator offering the defendant-generic some value greater than the generic company’s prospective profits, but less than the innovator company’s prospective loss. in exchange for the value received, the generic company foregoes or delays market entry, and thus the innovator pharmaceutical patenting practices 8 (2020), https://crsreports.congress.gov/product/pdf/ r/r46679 [https://perma.cc/yfd8-p5z3]. 43. u.s. fed. trade comm’n, generic drug entry prior to patent expiration: an ftc study, 13 (2002), https://www.ftc.gov/reports/generic-drug-entry-prior-patent-expiration-ftc-study [https://perma.cc/j5v9-9x8r]. 44. brian c. howard, hatch-waxman / anda litigation report 2017, global patent group, iii (april 2017), https://pages.lexmachina.com/email_andareport2017_lprequests.html [https://perma.cc/l9zg-8w4m]. 45. feldman & frondorf, supra note 21, at 511. 46. feldman, supra note 10, at 22, 25. 2024] incentivizing drug affordability 131 preserves its monopoly.47 the reverse payment settlement results in mutual economic benefit, and mutual avoidance of the risk of losing at trial. “reverse payment settlement agreement” reflects the counterintuitive nature of these agreements. “reverse” communicates that in the paragraph iv context, the plaintiff (patent-holding innovator) actually compensates the defendant, rather than the defendant settling the dispute by compensating the plaintiff. this is the reverse of the usual dynamic, in which a plaintiff suffers damages caused by a defendant, and the defendant settles the case by compensating the plaintiff. as the name suggests, the roles are reversed, with the plaintiff ironically compensating the defendant to resolve the dispute. while this is somewhat suspicious, the reversed flow of the settlement payment can somewhat be attributed to the unique nature of the paragraph iv proves. while the patent-holder is indeed the plaintiff, the generic challenger is the true provocateur via its paragraph iv certification stating that the innovator’s patent is invalid or would not be infringed. the substance of modern pay-for-delay agreements exhibit an impressive level of complexity, as a straight-forward quid pro quo—cash for exiting, or not entering, the market—would be considered antitrust on its face following the 2013 case of ftc v. actavis (as discussed later in this note).48 contemporary reverse payment settlements often avoid cash payments but include non-cash consideration to achieve the same result. the modern complexity is illustrated by the ftc’s analysis of these agreements, in which the agency may label an agreement as involving “possible compensation.”49 regardless of the complexity and specific terms of a reverse payment settlement, an anti-competitive reverse payment settlement boils down to a patentee compensating a would-be competitor to stay out of its market. although this note focuses on instances of abuse, many reverse payment settlements are pro-competitive and accelerate competition. when a patent is strong and likely to be upheld in court, a reverse payment settlement may actually bring the generic to market before the patent expires. even though the patent is probably valid and if so would be infringed, a risk-averse innovator might pursue a reverse payment settlement to eliminate the threat of an unlikely but extremely damaging trial outcome. in such situations, the parties compromise for a date of generic entry later than the generic company would prefer, but earlier than the date of the valid patent’s expiration.50 most reverse payment settlements are of this pro-competitive character and induce generic entry and associated discounts before the disputed patent would otherwise allow.51 47. feldman & frondorf, supra note 21, at 511. 48. id. at 516. 49. jamie towey & brad albert, then, now, and down the road: trends in pharmaceutical patent settlements after ftc v. actavis, competition matters (may 28, 2019), https://www.ftc. gov/enforcement/competition-matters/2019/05/then-now-down-road-trends-pharmaceutical-patentsettlements-after-ftc-v-actavis [https://perma.cc/g5lg-aen8]. 50. impax labs., inc. v. ftc, 994 f.3d 484, 493 (5th cir. 2021). 51. laura karas et al., pharmaceutical “pay-for-delay” reexamined: a dwindling practice or a persistent problem?, 71 hastings l.j. 959, 967-68 (may 2020), https://papers.ssrn.com/sol3/ 132 indiana health law review [vol. 21:121 even if they do not produce the pro-competitive effects of the previous example, reverse payment settlement agreements can be commercially reasonable and legally justifiable. consider that the 180-day generic exclusivity period begins running the day the first generic filer markets the drug. in the race to file first and win the 180-day exclusivity period as the first generic filer, the generic company’s challenge may be weak, or the innovator’s patent strong. further, and not uncommon for small innovators with one or few drugs, the innovator’s survival might depend upon the revenues currently protected by the challenged patent—the innovator’s risk tolerance might require the innovator to leave nothing to chance, even if a patent is strong. both parties want to avoid the binary risk of litigation for reasons beyond minimizing legal fees; the innovator expects to win but cannot afford to lose, and the generic expects to lose. to protect its patent, the innovator may offer to license marketing rights to the generic firm or commit to not launching its own authorized generic during the 180-day exclusivity period, which does not prohibit a company from selling its own fdaapproved product, repackaged and sold at a lower price. in exchange, the generic firm agrees not to launch its competing drug until the disputed patent expires. because losing at trial would negate the 180-day exclusivity right, the generic firm accepts these terms. the innovator is satisfied with the preservation of its likely-valid but life-giving patent, and the generic firm is satisfied with the preservation of its 180-day exclusivity right. however, the patient remains the source of inelastic demand in this market made less competitive by the reverse payment settlement. as illustrated, reverse payment settlement agreements can be pro-competitive and beneficial to patients, or simply within the boundaries of capitalism and antitrust and intellectual property law. while the good-faith nature of many reverse payment settlements must be recognized, this does not make anticompetitive reverse payment settlements any less expensive or any less detrimental to patients. originally characterized by undisguised quid pro quos, the classic version of anti-competitive reverse payment settlements eventually earned supreme court disapproval.52 before discussing the court’s decision, however, an analysis of other pay-for-delay strategies is warranted. v. analysis: diversifying delay the variation and depth of pay-for-delay—including well-disguised anticompetitive reverse payment settlements—is indefinite. although congress periodically attempts to define and outlaw specific manifestations of pay-fordelay, the menu of substitutes greatly mutes the intended effect of congressional efforts. “anti-competitive conduct can come in too many different forms, and is too dependent upon context, for any court or commentator ever to have enumerated all the varieties.”53 notwithstanding, this note attempts to describe papers.cfm?abstract_id=3458552 [https://perma.cc/pq2j-lqna]. 52. ftc v. actavis, inc., 570 u.s. 136, 141 (2013). 53. in re suboxone (buprenorphine hydrochloride & naloxone) antitrust litig., 64 f. supp. 2024] incentivizing drug affordability 133 several variations of pay-for-delay beyond reverse payment settlement agreements. a. citizen petitions the code of federal regulations—21 cfr §10.20-30—allows interested persons to submit “citizen petitions” to the fda whereby the interested person advises the agency to take, or refrain from taking, an action.54 sometimes these concerned citizens are pharmaceutical companies advising the agency to reject generic drug applications poised to compete with the brand name product. logically, the inventor of a drug is in an ideal position to identify risks or deficiencies associated with copying the invention. thus, it is understandable that petitions to block generics are frequently sourced by innovators with much to lose. nevertheless, the conflict of interest is obvious. citizen petitions raise various concerns with a drug’s safety profile, and are usually found immaterial. from 2008 to 2013, 124 petitions to delay generic approvals were filed, with only eight granted; a mere 6% of petitions opposing generic approvals raised credible issues.55 however, a citizen petition can delay generic competition without being granted. after the fda receives a citizen petition advising against an anda approval, the fda has 150 days to review the petition. during that 150-day period, the review of the anda for the respective generic drug is placed on hold.56 extending brand exclusivity—and therefore monopoly price—for 150 days can translate to hundreds of millions of dollars in sales for the company, and consequently hundreds of millions of dollars in cost to the healthcare system.57 exacerbating the problem, citizen petitions can be creatively deployed to maximize anti-competitive effect. for example, innovators can file numerous petitions targeted at a single generic applicant to amplify the redirection of fda resources. in 2018, a delaware district court dismissed an ftc complaint against shire viropharma.58 the ftc’s complaint alleged that viropharma “inundated the fda” with numerous filings, including 24 citizen petitions, intended to “maintain its monopoly on vancocin capsules.”59 another way to maximize delay is to wait until the 11th hour to file a petition. in 2015, bayer healthcare 3d 665, 679 (e.d. pa. 2014) (quoting west penn allegheny health sys., inc. v. upmc, 627 f.3d 85, 109 (3rd cir. 2010)). 54. 21 c.f.r. §§ 10.20, 10.30 (2022). 55. feldman & frondorf, supra note 21, at 546-47. 56. 21 c.f.r. § 10.30 (2022). 57. robin feldman & connie wang, a citizen’s pathway gone astray — delaying competition from generic drugs, 376 new eng. j. med. 1499, 1501 (apr. 20, 2017), https://repository.uclawsf.edu/cgi/viewcontent.cgi?article=2557&context=faculty_scholarship [https://perma.cc/7kqy-yycj]. 58. ftc v. shire viropharma inc., no. cv 17-131-rga, 2018 wl 1401329, at *1 (d. del. mar. 20, 2018), aff'd, 917 f.3d 147 (3d cir. 2019). 59. id. 134 indiana health law review [vol. 21:121 filed its citizen petition one day before the expiration of its patent.60 such timing effectively extends a patent by 150 days. antitrust recourse exists for severe abuse of citizen petitions but, as is thematic of all attempts to reign in pay-for-delay, high burdens of proof and vast grey areas allow careful players to leverage citizen petitions without becoming realistic targets for the ftc.61 citizen petitions remain a highly effective means of delaying generic competition. with additional planning and attention to detail, patentees can maximize the impact of a citizen petition by filing several petitions or by waiting until the eve of patent expiration to submit the petition. b. evergreening & product hopping “evergreening” informally refers to the practice of insulating a brand-name drug from competition by tacking on secondary patents for slight modifications made to the drug.62 these secondary patents extend market exclusivity beyond the life of the primary patent.63 when litigated to completion, the secondary patents are invalidated—68% of the time according to one study—more than upheld.64 evergreening is sometimes interchangeable with “product hopping” due to the appearance of “hopping” to a slightly different product with a later patent expiration.65 however, product hopping usually includes a marketing pivot. although not consistently defined, product hopping is generally “the switching of the market in order to stifle generic competition.”66 in practice, product hopping is often achieved by reformulating a drug to the point where a pending generic is no longer substitutable, and then encouraging doctors to prescribe the reformulated version instead of the original version which is the focus of generic developers.67 if effective, there will be no market for the generic drug because doctors and patients have “hopped” to the reformulated version. astrazeneca’s handling of prilosec—a multi-billion dollar per year earner for the company—is often cited as a product hopping example.68 as prilosec’s primary patent approached expiration, astrazeneca introduced nexium—a 60. michael a. carrier & carl minniti, citizen petitions: long, late-filed, and at-last denied, 66 am. u. l. rev. 305, 309, 346-47 (2017), https://digitalcommons.wcl.american.edu/cgi/ viewcontent.cgi?article=1956&context=aulr [https://perma.cc/8cer-gu6a]. 61. feldman & wang, supra note 56, at 1501; feldman & frondorf, supra note 21, at 547. 62. richards et al., supra note 41. 63. id. 64. feldman, supra note 10, at 21. 65. richards et al., supra note 41. 66. michael a. carrier & steve d. shadowen, product hopping: a new framework, 92 notre dame l. rev. 167, 169 (2017), https://papers.ssrn.com/sol3/papers.cfm?abstract_ id=2747526 [https://perma.cc/ekv8-agka]. 67. id. at 168-69. 68. alex brill, the cost of brand drug product hopping, matrix global advisors, at 4 (sep. 2020), https://www.affordableprescriptiondrugs.org/app/uploads/2020/09/ costofproducthoppingsept2020-1.pdf [https://perma.cc/2yeu-37jc]. 2024] incentivizing drug affordability 135 slightly modified version of prilosec with a largely equivalent therapeutic effect.69 unlike prilosec, nexium boasted 13 remaining years of patent protection.70 the launch of nexium was accompanied by a marketing campaign to switch prescribers from prilosec to nexium.71 beyond prilosec, product hopping strategies often leverage secondary patents to extend exclusivity. for example, an innovator can switch a product nearing patent expiration from a tablet to a capsule and enjoy fresh exclusivity afforded by the secondary patent associated with the capsule form.72 by product hopping, brand companies make subtle changes or improvements to existing drugs and encourage prescribers and patients to adopt this new and improved version. if successful, a company that developed a generic to the now outdated product is left with no market. the result is a sustained monopoly for the innovator’s branded product. while somewhat interchangeable, evergreening refers to layering patents onto an existing drug to prolong the monopoly environment, while product hopping usually suggests a marketing effort aimed at reducing demand for a previous iteration of a new but largely interchangeable product. firms evergreen a specific drug by layering on secondary patents, while product hoppers are less concerned with a specific drug’s primary patent expiration because demand has hopped to a new product. overcoming the numerous secondary patents guarding an evergreened product demands time and resources from generic challengers, which may ultimately gain approval only to enter a dead market due to product hopping.73 in either case, generic competition is delayed. c. constricting supply in addition to patent-based methods of delaying generic competition, the drug supply chain can be leveraged against generic suitors. in 2015, pharmaceutical executive martin shkreli gained notoriety when he increased the price of daraprim—a drug used to treat toxoplasmosis, a rare parasitic infection—from $17.60 to $750.00.74 the price hike, aided by shkreli’s candid personality and unapologetic response, drew criticism from politicians, the public, and of consequence, regulators. the ftc filed an antitrust lawsuit against shkreli which revealed an impressive pay-for-delay strategy.75 in ftc. v. shkreli, shkreli’s company, vyera, lacked patent protection for daraprim, but successfully delayed generic competition for eighteen months (the drug was actually over 60 years old, but the low price and small patient population made daraprim commercially unattractive to generic companies 69. id. 70. id. 71. id. 72. id. 73. richards et al., supra note 41. 74. ftc v. shkreli, 581 f. supp. 3d 579, 601 (s.d.n.y. 2022). 75. id. 136 indiana health law review [vol. 21:121 which did not pursue generic daraprim until this development).76 the 18-month delay was responsible for almost $65 million in continued monopoly sales.77 vyera executives failed to disguise a series of tactics and agreements that prevented prospective generic entrants from obtaining the supplies necessary to receive fda approval.78 to earn fda approval of an anda, the generic anda filer must demonstrate its ability to produce the reference product (the “reference product” is the brand drug the generic seeks to emulate) and comply with certain production standards.79 in this process, the generic company must acquire the reference product—daraprim—as well as the primary ingredient responsible for the therapeutic effect—pyrimethamine.80 through a series of agreements, vyera positioned itself as the gatekeeper of the supplies necessary to develop a generic, including the active ingredient—pyrimethamine—and daraprim itself.81 by placing daraprim in a closed, or “specialty,” distribution network, daraprim’s generic suitors could not obtain the drug without vyera’s approval, which vyera refused to provide.82 vyera then negotiated exclusive supplier agreements with the few authorized sellers of pyrimethamine, cutting off generic companies from daraprim’s essential ingredient.83 this case notably lacked any serious pro-competitive evidence to justify the actions, and thus the court held shkreli liable with an unusual degree of ease and punitive wrath.84 d. recap: diversifying delay while reverse payment settlements are the classic examples of delaying generic entry, methodology has evolved. today, citizen petitions, evergreening, product hopping, and exclusive supplier agreements are responsible for delayed generic entry in addition to some reverse payment settlements. citizen petitions allow firms to prolong market exclusivity by raising artificial concerns about pending generic products. firms evergreen existing drugs by tacking on secondary patents to extend monopoly protection beyond expiration of the primary patent.85 product hopping occurs when an innovator firm deploys marketing resources to redirect demand for a drug facing imminent generic competition to a new market for a slightly amended version of the same drug. if a drug has no patent protection, innovators can still protect a monopoly market by contractually prohibiting suppliers from supplying necessary ingredients to 76. id. at 590. 77. id. at 591. 78. id. at 633-34. 79. id. at 595-96. 80. id. at 605. 81. fed. trade comm'n v. shkreli, 581 f. supp. 3d 579, 605 (s.d.n.y. 2022). 82. id. at 602. 83. id. at 602-03. 84. id. at 636-38. 85. richards et al., supra note 41, at 1. 2024] incentivizing drug affordability 137 generic developers. also without patent protection, an innovator can restrict distribution of the drug itself to strain generic developers that require the reference product as a prerequisite to fda approval. each strategy burdens patients and the healthcare system at large with higher prices and lower access. vi. analysis: current approaches fall short pay-for-delay is recognized by policymakers as a problem. however, the private firms engaging in the practice are nimbler than the institutions seeking to reign in drug prices. the judiciary and the federal legislature have implemented and proposed solutions and there has been some effective enforcement, but no current or proposed approach is dynamic enough to attack the broad practice of pay-for-delay at its core. a. existing law: ftc v. actavis the classic iteration of pay-for-delay—reverse payment settlement agreements—was confronted by the supreme court in 2013.86 in ftc v. actavis, the ftc urged the supreme court to hold all reverse payment settlements presumptively unlawful.87 actavis recommended an opposite stance, asserting that reverse payment settlements should be immune from antitrust liability as long as the settlement’s anti-competitive effects fell within the exclusionary scope of the patent.88 the court declined to adopt either position and instead established a “rule of reason” test.89 when applying the test, courts weigh the anticompetitive effects of a reverse payment settlement against any pro-competitive justifications, evaluating the agreements on a case-by-case basis.90 thus, reverse payment settlements in patent infringement suits are neither immune from antitrust attack, nor presumptively unlawful.91 the 5-3 decision stated considerations relevant to the determination of an agreement’s antitrust character while also navigating considerations of patent law. factors indicative of a pay-for-delay character importantly include the size of the payment, as a larger payment may suggest a weaker patent.92 attempting to reconcile patent rights with antitrust considerations, the court stated “the size of the unexplained reverse payment can provide a workable surrogate for a patent's weakness, all without forcing a court to conduct a detailed exploration of the validity of the patent itself.”93 another factor is the absence of an exchanged service for which a large payment may be compensation.94 by applying this fact86. see ftc v. actavis, inc., 570 u.s. 136, 141 (2013). 87. id. at 158-59. 88. id. 89. id. 90. id. at 159. 91. id. at 146-54. 92. id. at 158. 93. id. at 158. 94. karas et al., supra note 50, at 963. 138 indiana health law review [vol. 21:121 specific approach, there is a viable avenue to attack egregious reverse payment settlements. of course, the analysis also presents boxes to check for parties wishing to disguise an anti-competitive reverse payment settlement. commentators have characterized applications of the rule of reason test in payfor-delay contexts as “notoriously convoluted.”95 this characterization draws support from the dissenting chief justice roberts, who wished “good luck to the district courts that must, when faced with a patent settlement, weigh the likely anti-competitive effects, redeeming virtues, market power, and potentially offsetting legal considerations present in the circumstances.”96 by leaving room for antitrust liability despite an existing patent, the 5-3 ftc v. actavis opinion was a step in the direction of deterring pay-for-delay. indeed, the prevalence of reverse payment settlements decreased following the decision.97 ultimately, however, the decision accelerated a shift to alternatives like citizen petitions, evergreening, product hopping, and supply constraints. further, the decision caused parties to increase the complexity of their agreements and therefore the burden of proving illegality.98 since 1997 (the rule of reason standard has applied to other antitrust issues longer than it has applied to reverse payment settlements), plaintiffs litigating against a rule of reason standard fail to show a substantial anti-competitive effect 90% of the time.99 b. proposed law many proposed legislative solutions, while perhaps effectively striking at a specific means of pay-for-delay, are unlikely more than band-aid solutions. the preserve access to affordable generics and biosimilars act (“paagba”) is one such proposal that is emblematic of the disadvantage associated with current legislative approaches to the problem. while pay-for-delay parties can nimbly adjust tactics and employ new strategies to disguise and sustain anti-competitive action, policymakers laboriously piece together bills aimed at small targets and which rarely graduate from legislative committees. the paagba, if enacted, would attack reverse payment settlement agreements by presuming an antitrust violation when infringement suits settle with an exchange of value resulting in an anda filer agreeing to “limit or forgo research, development, manufacturing, marketing, or sales of the anda product or biosimilar biological product, as applicable, for any period of time.”100 essentially, the paagba would skirt the burden imposed by the supreme court in ftc v. actavis of proving anti-competitive conduct under the rule of reason 95. feldman, supra note 10, at 13. 96. actavis, inc., 570 u.s. at 173. 97. karas et al., supra note 50, at 964. 98. feldman, supra note 10, at 15. 99. ncaa v. alston, 141 s. ct. 2141, 2161 (2021). 100. preserve access to affordable generics and biosimilars act, s. 1428, 117th cong. § 27(a)(2)(a)(ii) (as reported in the senate, dec. 9, 2021). 2024] incentivizing drug affordability 139 test.101 defendants would then be tasked with rebutting the anti-competitive presumption by clear and convincing evidence. a legal, and in effect political obstacle to the proposed paagba arises in the necessary juxtaposition of patent law with antitrust law. in contrast to ftc v. actavis, which struck a balance between patent and antitrust considerations, the paagba would value antitrust risk above patent rights. patents essentially confer antitrust immunity to their holder by granting a temporary, legal monopoly,102 and patents “shall be presumed valid” with the burden of establishing invalidity “on the party asserting such invalidity.”103 because a patent may constructively immunize its holder against antitrust liability, the paagba’s presumption of antitrust behavior necessarily requires a simultaneous presumption of the patent’s invalidity. due to the suspicious nature of reverse payment settlements, the supreme court in actavis allowed antitrust claims to proceed through a rule of reason test notwithstanding presumed patent validity but rejected the ftc’s position that illegality of reverse payment settlements should be presumed.104 while actavis sought an equilibrium between patent and antitrust considerations, the paagba would summarily override patent rights in cases of reverse payment settlements. such a departure from established treatment of intellectual property—presuming antitrust behavior, effectively presuming patent invalidity, and placing the initial burden of proof on the patent holder—has struggled to gain traction, perhaps because of the reasonable proposition that the presumption of validity is “rightly based on the expertise of patent examiners presumed to have done their job.”105 even if the paagba overcame political and interest group opposition, it offers minimal benefit because it addresses one of many techniques used to prolong market exclusivity. if the risk of liability associated with reverse settlement payments increases, brands will take another angle. for instance, instead of reverse payment settlements, brands would increase the number of patents filed on the drug and create a “patent thicket.”106 over the course of years, congress could theoretically legislate pressure on different methods of delaying generics, only to be front-run by offenders leveraging new tactics to achieve the same result—minimal competition and high prices. dozens of bills akin to the paagba have been considered in the wake of actavis, producing little material progress. rather than focusing efforts on futile attempts to tighten the regulatory grip on innovators and generics, policymakers should examine the bigger picture. instead of trying and failing to punish anticompetitive conduct after the fact, congress should implement a non-punitive 101. richards et al., supra note 41. 102. actavis, inc., 570 u.s. at 136. 103. 35 u.s.c. § 282(a) (2022). 104. actavis, inc., 570 u.s. at 138. 105. in re humira (adalimumab) antitrust litig., 465 f. supp. 3d 811, 834 (n.d. ill. 2020), aff'd sub nom. see also, mayor of baltimore v. abbvie, inc., 42 f.4th 709 (7th cir. 2022) (quoting brooktree corp. v. advanced micro devices, inc., 977 f.2d 1555, 1574 (fed. cir. 1992). 106. richards et al., supra note 41. 140 indiana health law review [vol. 21:121 solution by incentivizing firms away from pay-for-delay strategies. vii. incentivizing affordability: priority review & wildcard exclusivity because the push of penalty-based approaches rarely materializes, the pull of two incentive-based approaches should be explored: (1) fda priority review vouchers (“prvs” are not uncommonly valued in the hundreds of millions),107 and (2) transferable wildcard exclusivity vouchers (“wildcards”). with built-in safeguards against abuse, issuing these assets to firms in exchange for unilateral price decreases or facilitation of generic entry could reduce the appeal of pay-fordelay and thereby improve affordability and access. a. priority review vouchers priority review vouchers reduce the fda review period of any new drug application (“nda”) by four months (ten months shortened to six months).108 prvs are currently used to incentivize low profitability, high-need research and development in the areas of tropical disease, rare pediatric disease, and illnesses related to public health emergencies.109 companies sponsoring development in these areas are awarded prvs, which are ultimately redeemed by the awardee, or by another company that purchased the prv from the awardee, for accelerated review of any nda. bringing a patented drug to market four months faster through a prv translates to four additional months of monopoly pricing—without having to delay generic entry. factoring in the cost of delaying generic entry (e.g., litigation, document preparation, filing fees, reverse payment settlements), it is fully possible that obtaining a prv would outweigh delaying generic entry. even without factoring in the cost of delay efforts, in some situations, the market value or sale price of a prv would ideally exceed the value of prolonged monopoly pricing achievable through pay-for-delay. further, using prvs increases the likelihood that profits will be reinvested in research and development because after all, the voucher is used to review a new drug application. allowing the fda to flex the pace of accelerated approval based on the quality of the company’s pro-competitive, price-lowering conduct would also add to the effectiveness of this approach. the marketability of prvs is essential to their appeal.110 since the fda began awarding prvs in 2007, the government accountability office has used 107. u.s. gov’t accountability off., gao-20-251, drug development: fda’s priority review voucher programs (jan. 2020), https://www.gao.gov/assets/gao-20-251.pdf [https://perma.cc/cnq8-fku6]. 108. u.s. gov’t accountability off., supra note 105, at 2. 109. food and drug administration amendments act of 2007, pub. l. no. 110-85, § 1102, 121 stat. 823, 972 (2007); food and drug administration safety and innovation act, pub. l. no. 112-144, § 908, 126 stat. 993, 1094 (2012); 21st century cures act, pub. l. no. 114-255, § 3086, 130 stat. 1033, 1145 (2016); u.s. gov’t accountability off., supra note 105. 110. id. at 13-14. 2024] incentivizing drug affordability 141 available data to report prv sale prices ranging from $67.5 million to $350 million.111 if appropriately implemented, this program could bring both innovative and generic drugs to market faster. the effect is a positive-sum game, where all stakeholders—brand-name companies, generic companies, patients, taxpayers—can make and save money together. an expanded prv program is not without drawbacks. one major hindrance to prv expansion is the inflationary effect of introducing more prvs to the market. however, if the fda has the latitude to tailor the value of the prvs by varying the timeframes and setting expiration dates, the agency could ensure the prvs retain value regardless of how many are issued. this solution in turn requires more bandwidth from the fda, which is a drawback in its own right. if adopted, this expansion requires a complementary increase in fda funding to make sure the agency is appropriately staffed to administer the program. a prv inventive program could also be improved upon by designing a larger menu of incentives outside the scope of this note, such as tax credits and fda user fee waivers. however, introducing more incentives would do little, if anything, to mitigate prv-specific drawbacks, and additional incentives would again implicate fda bandwidth. futility risks ultimately counsel against prv expansion. from the 2009 inception of the prv program through 2019, thirty-one prvs had been issued—seventeen have been sold, and sixteen have been redeemed (some prvs have been both sold and redeemed, hence the combined amount sold and redeemed exceeds the total number of prvs issued).112 for an illustration of prv issuances and redemptions, see figure 2. figure 2113 111. id. 112. u.s. gov’t accountability off., supra note 105. 113. id. 142 indiana health law review [vol. 21:121 the prv program—in its fourteenth year of existence in 2023—is already experiencing inflation which would be exacerbated by a major expansion of the program. the program has already expanded to incentivize three distinct areas of drug development, and the marginal utility of obtaining a prv shrinks with each additional prv entering circulation. the steady decrease in prv sale prices is depicted by figure 3, below. figure 3114 if prvs were effective incentives in the context explored by this note, many would be issued and drug prices would decrease. however, increasing the prevalence of prvs would eventually saturate the prv market to a point where the value of earning a prv would seldom rival the opportunity cost of delaying generic entry. although only some prv sale prices have been publicized, it is difficult to dispute the economic reasoning that higher prv supply causes lower prv demand, and thus lower prv sale prices. in other words, the program’s success in lowering drug prices would be unlikely to last. this is not to say the prvs would ever be valueless, but as more prvs are issued it becomes less and less likely that the prvs value would outweigh the value of longer market exclusivity. the prv program has already expanded to include three areas, and expanding it once again to encourage indefinite prv issuances could quickly exhaust the program’s value. not only would this render prvs moot as an incentive to price reduction, but the inflationary harm would metastasize to existing targets of the prv incentive program, namely tropical disease, rare pediatric disease, and public health emergency countermeasures. furthermore, fda bandwidth is finite. the program’s success and more prv issuances would strain fda resources. eventually, it would be impossible for the 114. id. at 15. 2024] incentivizing drug affordability 143 fda to meet the shorter timeframes of priority review. there are already examples where the fda had to extend prv deadlines, thereby muting the advantage of using a prv. in november 2022, argenyx spent $102 million acquiring a prv from bluebird bio, which argenyx submitted to shorten fda review of vygart—used to treat generalized myasthenia gravis in adults—by four months.115 in january 2023, the fda informed argenyx that the pdufa date (prescription drug user fee act date; the date by which fda must respond to new drug applications) would be extended from march 20, 2023 to june 20, 2023 “to allow sufficient time to review.”116 another recent example of the fda’s bounded capacity impacted japan-based astellas pharma and the company’s menopause drug candidate, fezolinetant. in a high-stakes push to be the first to market, astellas used a prv—valued at $97 million on astellas’ books—to trim four months off the fda’s review of fezolinetant, establishing a pdufa date of february 22, 2023.117 on february, 17—just five days before the deadline—astellas was notified “that the fda is extending the pdufa goal date by three months, to may 22, 2023, to allow more time to complete their review.”118 the institute for clinical and economic review (icer)—a nonprofit dedicated to studying the cost-effectiveness of medicine—estimated that 3,340,000 patients would begin fezolinetant treatment each year, and recommended a price between $2,000 and $2,500 per year.119 assuming approval and a highly efficient launch, the three-month delay could directly reduce astellas’ fezolinetant sales by hundreds of millions of dollars. the pertinent point here, however, is that the prv failed to materialize into any competitive advantage. the setbacks befalling argenyx and astellas highlight the boundaries of fda capacity in the priority review context and suggest that the effect of prv expansion explored in this note, even if authorized by congress, would struggle to materialize at scale. 115. nicole defeudis, argenx purchases $100m+ fda priority review voucher from bluebird bio, endpoints news (nov. 30, 2022), https://endpts.com/argenx-purchases-100m-fdapriority-review-voucher-from-bluebird-bio/ [https://perma.cc/tf3q-nnms]. 116. argenyx receives notification of pdufa date extension for sc efgartigimod, globenewswire (jan. 27, 2023), https://www.globenewswire.com/news-release/2023/01/ 27/2596602/0/en/argenx-receives-notification-of-pdufa-date-extension-for-scefgartigimod.html [https://perma.cc/dk7b-ka8b]. 117. katherine lewin, astellas' menopause drug hit by fda delay after spending $97m on a priority review voucher, endpoints news (feb. 21, 2023), https://endpts.com/astellasmenopause-drug-hit-by-fda-delay-after-spending-97m-on-a-priority-review-voucher/ [https://perma.cc/5eau-2bjr]. 118. astellas provides update on fezolinetant new drug application in u.s., pr newswire (feb. 19, 2023), https://www.prnewswire.com/news-releases/astellas-provides-update-onfezolinetant-new-drug-application-in-us-301750449.html [https://perma.cc/6d9m-svfq]. 119. francesca l. beaudoin et al., fezolinetant for moderate to severe vasomotor symptoms associated with menopause: effectiveness and value, inst. clinical & econ. rev. at 58 (dec. 1, 2022), https://icer.org/wp-content/uploads/2022/06/icer_menopause_evidencereport_12012022.pdf [https://perma.cc/u8aa-uu4s]. 144 indiana health law review [vol. 21:121 fortunately, there may be another low-friction avenue to lower drug spending. in a gao study, the existing prv program was evaluated, and potential alternatives explored.120 stakeholders interviewed by the gao suggested alternative incentives which, among industry participants, were viewed as superior to prvs.121 gao interviewees and literature specifically identified incentives related to market exclusivity.122 not only was exclusivity more attractive to stakeholders than prvs, but the major drawbacks of an expanded prv incentive—inflationary effect on prv value, fda bandwidth, overall exhaustion of prv system—are less applicable to an appropriately tailored market exclusivity incentive. b. wildcard exclusivity vouchers the preferred solution recommended by this note is a transferable, wildcard exclusivity voucher (“wildcard”). drug developers that facilitate generic entry or unilaterally reduce price would be awarded a wildcard exclusivity voucher, to be redeemed for extended market exclusivity for another drug, or sale to another drug developer. this wildcard incentive, appropriately limited, would offer innovators a lawful, transparent, predictable path to value without sacrificing competition and affordability in the process. unadopted in any form in the u.s., wildcard exclusivity has been explored by some industry stakeholders and u.s. policymakers as a means to incentivize antibiotic development.123 however, leveraging wildcard exclusivity to induce lower drug expenditures is novel. (a) outlining the wildcard exclusivity program a wildcard exclusivity program would reward price reductions and faster generic competition with wildcard exclusivity vouchers. a firm seeking to qualify should file an application with the fda, or other government body, forecasting the future savings of a price-reduction. the estimated figure might reasonably be derived by multiplying the difference between previous brand price and expected generic price by volume, with volume calculated based on average prescription volume per year multiplied by the number of years before patent expiration that the price reduction occurs. if the projected savings resemble those typically created by generic entry—discount of 20% in first 180 days and incrementally increasing thereafter—the firm is rewarded with a wildcard exclusivity voucher.124 to ensure material savings, the discount must reach the typical peak 120. u.s. gov’t accountability off., supra note 105. 121. id. at 29. 122. id. 123. kurt karst, “wildcard exclusivity” returns: pcast recommends consideration of a tradable voucher to reward successful antibiotic development, fda law blog (sep. 29, 2014), https://www.thefdalawblog.com/2014/09/wildcard-exclusivity-returns-pcast-recommendsconsideration-of-a-tradable-voucher-to-reward-successf/ [https://perma.cc/7bwv-pdu4]. 124. feldman & frondorf, supra note 21, at 500-01. 2024] incentivizing drug affordability 145 generic discount—75-80%--at least 180 days prior to primary patent expiration.125 once price drops occur, they may not be undone without repaying a sum equal to projected savings. if actual savings fall short of forecasted savings, the firm may be forced to pay a rebate equal to the difference between estimated and actual savings. thus, the savings number is essentially “locked in” and may be relied upon by fda/hhs in awarding the wildcard voucher. like a prv, the wildcard would be transferable (sellable), and this transferability component would help increase r&d in addition to increasing the value of the wildcard. if the firm that earns the wildcard has no product that foreseeably stands to benefit from extended market exclusivity, obtaining a wildcard remains valuable because the firm can sell the wildcard to another manufacturer standing to benefit from its use. thus, the value of transferability is responsible for an indispensable portion of the wildcard’s ability to function as an incentive. because transferability is a significant flexibility advantageous to brands and because wildcards indeed work to extend monopolies, several limitations on wildcard usage would prohibit unreasonable extensions—often attributable to pay-for-delay in the current environment—and ensure the wildcard provides consumers with a net gain. (b) risks and mitigants several vulnerabilities must be addressed to ensure the program results in net savings. the first important limitation to set on wildcard usage should be to establish a maximum monopoly length that wildcard redemption can result in. the feasibility of three sub-approaches to this limitation should be explored further. the first sub-approach: prohibit wildcard use where it would result in exclusivity greater than 14 years. the second: prohibit wildcard use where it would result in an exclusivity period exceeding the average small-molecule or biologic exclusivity period, as applicable. the average exclusivity period could be calculated based on industry-wide inputs available in the fda orange book. the third and perhaps most straight forward sub-approach is to allow wildcard redemption where it would result in “extended monopolies,” but prohibit usage if it would result in a “long-monopoly.” extended-monopoly drugs are drugs “for which at least 12 years, but fewer than 16 years, have elapsed since the date of approval of such drug.”126 long-monopoly drugs are drugs for which greater than 16 years have elapsed since approval.127 one of these sub-approaches could be adopted, or all three could be utilized on a case-by-case basis. fact-specific, caseby-case utilization of all three may be appropriate given significant differences between biologics and small-molecule drugs (and between biosimilars and generics for that matter)128 as far as r&d cost, value creation, and approval 125. id. 126. 42 u.s.c. § 1320f-3(c)(4) (2022). 127. 42 u.s.c. § 1320f-3(c)(5) (2022). 128. biologics are derived from living organisms, while small-molecule drugs are derived from chemicals. biosimilars are to biologics as generics are to small-molecule drugs. there are 146 indiana health law review [vol. 21:121 pathways. regardless of which method governs the cap on monopoly extension, wildcards should never contribute to exceptional delays in competition and unjustified prolonging of monopoly prices, which is the problem it seeks to address. regarding another limitation, wildcards should not operate to create uncertainty for generic firms. wildcard redemption for a specific drug should occur no later than two years after a drug’s initial fda approval (or an alternative deadline determined with input from generic subject matter experts or a notice and comment period). requiring the wildcard to be redeemed early in a product’s market lifecycle provides visibility regarding the legal conclusion of brand name monopolies. generic firms must be able to reliably invest in the years-long generic drug development process, without risk of being “blindsided” by a late wildcard redemption.129 allowing brands to bolt on exclusivity late in their product’s exclusivity period would add uncertainty to the generic business model that would disincentivize investment. therefore, brand companies should be estopped from redeeming wildcards after generic makers have materially invested in the generic development process. requiring prompt redemption of wildcards protects the predictability essential to generic development. (c) preventing abuse the surface irony of addressing the problem with additional market exclusivity must be overcome by eliminating the risk of abuse. consider circumstances where a firm facilitates generic competition or unilateral price reduction, generates $5 in savings (derived by multiplying the difference between the former brand price minus generic price by volume. volume determined using average prescription volume/year multiplied by the years prior to patent expiration that the price reduction occurs.), and then sells the wildcard to a firm which uses it to prolong monopoly sales, and thus cost, that exceed the savings ($5) originally generated. if unaddressed, this dynamic would completely undermine the program. to eliminate potential for abuse, the fda or other hhs agency must be armed with broad discretion regarding acceptance of wildcard redemption. specifically, the government must be allowed to reject or otherwise block wildcard redemption on the basis that wildcard attributable cost (the future extended monopoly sales protected by wildcard redemption) exceeds wildcard attributable savings (or forecasted wildcard attributable savings). thus, a wildcard should not be redeemable in situations where the cost of wildcard exclusivity very meaningful differences between biosimilars and generics – for instance, biosimilars are not covered by hatch-waxman. the substance of this note is limited to generics and small-molecule drugs, but a parallel application of the wildcard concept to biologics and biosimilars is worthy of exploration. 129. the science of biosimilars: let’s see how biosimilars are developed, pfizer (aug. 2021) (comparing biosimilar development to generic development), https://www.pfizerbiosimilars. com/biosimilars-development [https://perma.cc/ky6r-murp]. 2024] incentivizing drug affordability 147 exceeds the savings that earned the wildcard in the first place. the wildcard program would create savings up front when the wildcard is awarded, before creating costs later when the wildcard is redeemed to prolong market exclusivity (i.e., monopoly prices), but the savings would exceed the cost—the program must be qualified by a requirement that savings outweigh costs. bound by the condition that wildcard savings exceed wildcard costs, parties will navigate a process that safeguards this principle. to redeem a wildcard and reap the benefits of monopoly extension, the redeemer should undergo a process similar to that undertaken by the original wildcard awardee, whether it be the same firm or a firm that purchased the wildcard from the original awardee. records of the savings generated or forecasted would exist on record as part of the original wildcard voucher application. the party seeking to redeem the wildcard should submit to the fda or other designated federal body a wildcard redemption application that forecasts wildcard attributable revenue. if the redeemer’s forecasted wildcard attributable revenue exceeds the awardeegenerated wildcard attributable savings, the wildcard may not be redeemed because the result would be higher net drug spending. also in tandem with the front-end wildcard awardee application, the redeemer on the back-end must attest that savings will outweigh costs. if savings do not outweigh cost, the redeemer must be liable for any balance by which actual wildcard costs exceed actual wildcard savings. (d) wildcards as the optimal incentive although novel and untested, wildcard exclusivity offers superiority over the expansion of an already twice-expanded prv program with onerous administrative burdens and whose incentive value shrinks with each prv issued. between the first and second drafts of this note, the fda has twice been unable to satisfy priority review deadlines.130 advocating for an indefinite number of additional prv issuances would be naïve in this climate, even if such a proposal might achieve savings in optimal conditions. the wildcard, on the other hand, requires no scientific review and spreads administrative burdens and costs among parties. regarding application information and forecasting data, synergies exist on the applicant side as many firms will have sales projections and the estimated impact of generic competition baked into an existing strategic plan or, with respect to historical data, otherwise readily available in order to comply with sec reporting requirements. in short, the “ask” is lower for the fda, and the value of a wildcard on the balance sheet far outweighs the administrative cost absorbed by the hopeful awardee or party seeking to redeem the wildcard. not only does the wildcard program not ask the fda to condense a tenmonth process into six months, but the wildcard also fits the “transferable exclusivity” profile which the pharmaceutical industry has a great appetite for and 130. argenyx receives notification of pdufa date extension for sc efgartigimod, supra note 114; lewin, supra note 115. 148 indiana health law review [vol. 21:121 expressly favors over prvs.131 as proposed in this note, the wildcard system avoids a “ready-fire-aim” approach to granting monopoly extensions and is tempered by limitations that define: (1) prerequisites for earning a wildcard, (2) prerequisites for redeeming a wildcard, and (3) consequences of repayment, to be imposed on awardees and redeemers who fail to consummate the savings forecasted in wildcard award or wildcard redemption applications. wildcards have a dual effect—first a spending reduction, and then a spending increase—but because the saving occurs and is recorded first, it can be ensured that the later spending does not exceed the earlier amount saved, and thus that each wildcard results in net savings. the goal of the program, and that of each wildcard issued, is clear—accelerate price reduction and grow access. the obligation of awardees and redeemers to fulfill the savings goal of each wildcard amounts to an insurance policy against situations where, but for the drug maker’s obligation to pay off any negative balance between projected and actual savings, wildcard attributable spending would exceed wildcard attributable saving. viii. conclusion delayed generic entry caused by the anti-competitive actions of players in the pharmaceutical industry annually adds billions of dollars in cost to the u.s. healthcare system.132 attempts to quantify the annual burden have estimated a range from $3.5 billion to $37 billion.133 the unnecessary cost of pay-for-delay contributes to high prescription drug spending, which translates to poor health outcomes for patients who avoid medication due to price.134 attributable in part to the complexity of the pharmaceutical industry (including positive use cases for reverse payment settlements, citizen petitions, and other conduct described in a negative light in this note) and in spite of the dollar and personal health costs, historic approaches to combatting pay-for-delay are limited and difficult to enforce. this note described two low-friction approaches—attractive to all stakeholders and unlikely to encounter serious resistance—and ultimately endorses a wildcard incentive program offering extended market exclusivity for one drug, in exchange for shortened exclusivity for another drug, as long as “wildcard attributable savings” exceed “wildcard attributable spending.” if the incentive program proposed in this note prevents just a quarter of the annual cost of delayed generic competition from accumulating, billions of patient and public dollars would be saved and more americans could afford their prescriptions. while appropriately limited to avoid unintended cost increases, transferable wildcard exclusivity vouchers would remain highly valuable and therefore successfully induce lower drug prices, either directly through unilateral price reductions or indirectly through earlier generic entry. the american public, and especially patients, collectively share the cost of 131. u.s. gov’t accountability off., supra note 105. 132. feldman, supra note 10, at 32-33. 133. id. 134. kaiser fam. found., supra note 6. 2024] incentivizing drug affordability 149 pay-for-delay either directly or indirectly. despite the practice’s notoriety, victories in reducing pay-for-delay are few and far between. of the examples of progress discussed in this note, most can be circumvented. thus, instead of attempting and failing to identify and punish wrong, lawmakers should reward right. rewarding innovators with a marketable asset, in exchange for facilitating generic competition in monopoly markets, will bring cheaper drugs to patients faster without deterring private investment in innovation. as a viable, positivesum solution, the proposed wildcard exclusivity program should be discussed and expanded upon by policymakers, generic firms, innovator firms, and other stakeholders. refined with stakeholder input, a carefully implemented wildcard exclusivity program may blaze a new trail on the pay-for-delay frontier and produce an unprecedented symbiosis among generic and innovator companies. reduce juvenile recidivism: why indiana should mandate the individualized education programs (ieps) to juveniles with disruptive behavior disorders kaelyn m. bowman* i. introduction the son of virsarah davis spent enough time in juvenile detention that the reasons for detainment blur together in her memory.1 he had an outburst at school.2 he was caught with a weapon.3 he fled house arrest.4 but davis does know one thing for certain: her son was only ten years old the first time and afterwards kept referring to it as “a scary place.”5 davis thought the ordeal was over when he was released fifteen days later, but instead it was just the beginning.6 indiana detains and commits youth at a rate that is roughly 40% higher than the national average, and higher than almost every state in the midwest.7 during the eight years davis’s son was in and out of detention, his mother said he was always different when he came back home, and often behaved like he was still there.8 she stated, “i feel like my son is becoming institutionalized.”9 the consequences of a detention can be dire for youth.10 there is abundant research on juvenile incarceration, and many indicate that when youth are locked up, they are less likely to graduate from high school, even upon release.11 there is also a far greater increase in the risk of recidivism in the future.12 advocates in indiana indicate that courts detain many adolescences who should remain in the * j.d., indiana university robert h. mckinney school of law, with special acknowledgement to both my personal law note advisors, tyler e. burgauer and david l. morris. 1. dylan peers mccoy & katrina pross, why indiana locks up more children and teens than new york, wfyi indianapolis (nov. 16, 2022), https://www.wfyi.org/news/articles/indianadetains-commits-at-a-rate-40-above-the-national-average [https://perma.cc/jx85-y2r5]. 2. id. 3. id. 4. id. 5. see id. (quoting a direct quote from virsarah davis, the mother of the son who is held in juvenile detention mentioned within the article). 6. id. 7. id. 8. id. 9. see id. (quoting a direct quote from virsarah davis). 10. molly mccluskey, what if this were your kid, the atlantic (dec. 2017), https://www.theatlantic.com/politics/archive/2017/12/juvenile-solitary-confinement/548933/ [https://perma.cc/n56w-92vw]. 11. id. 12. id. 152 indiana health law review [vol. 21:151 community.13 there are plenty of intervention methods that can be put in place to prevent juveniles from coming in contact with detention centers.14 but what about those who will inevitably spend a good portion of their adolescence here? what can be done to help them? a child commits a delinquent act if, before becoming eighteen years of age, the child commits an act that would be an offense if committed by an adult, except for acts committed by the person over which the juvenile court lacks jurisdiction under ic § 31-30-1.15 youth who are involved in the justice system are particularly vulnerable to academic challenges and failure.16 youth who have been detained are less likely to graduate from high school or may not even return to school once released.17 this note discusses the effectiveness of current education for juvenile detention centers which are used by the state of indiana and many other states across the nation in an effort to minimalize recidivism. central to this note is the individualized education programs. individualized education programs (ieps) are specialized education programs uniquely developed for each individual child with a disability in order to enhance and progress through their learning effectively.18 currently, ieps are frequently implemented in public and private school alike across the country and are guided by the u.s. department of education and state education programs.19 ieps can be extraordinarily effective and provide the ability for multiple impactful adults, including the child’s parents, school administrators, and even therapists or doctors, to come together as a group and advocate for the best course of action to help a child educationally.20 another main pillar to this note are disruptive behavior disorders (dbds). according to the american psychiatric association, dbds are defined as a group of disorders that are connected by varying difficulties controlling aggressive behaviors and self-control impulses.21 further, the resulting behaviors are considered “a threat primarily to others’ safety and/or societal norms. some examples include fighting, destroying property, defiance, 13. mccoy & pross, supra note 1. 14. id. 15. ind. code § 31-37-1-2 (2017). 16. data report: youth in the justice system, ind. youth inst. (mar. 2021), https://www. iyi.org/wp-content/uploads/2021/03/juvenile-justice-report_final.pdf [https://perma.cc/t9kggr94]. 17. id. 18. access computing: what is the difference between an iep and a 504 plan, univ. of wash. (2006-2023), https://www.washington.edu/accesscomputing/what-difference-between-iepand-504-plan [https://perma.cc/37pv-b5s7]. 19. a guide to the individualized education program, u.s. dept. of edu. (aug. 30, 2019), https://www2.ed.gov/parents/needs/speced/iepguide/index.html, [https://perma.cc/6fpa-wlum]. 20. id. 21. what are disruptive, impulse control, and conduct disorders, american psychiatric assoc. (sept. 2021), https://www.psychiatry.org/patients-families/disruptive-impulse-control-andconduct-disorders/what-are-disruptive-impulse-control-and-conduct [https://perma.cc/lz2ymwpl]. 2024] reduce juvenile recidivism 153 stealing, lying, and rule breaking.”22 juveniles with dbds are at a higher likelihood of recidivism just by the nature of their disorders.23 additionally, indiana requires children between the ages of 7 and 18 (unless graduation prior to 18), to obtain a formal education, whether it be public, private, or home school.24 therefore, it is paramount that children receive a quality education, even when incarcerated. however, education for youth who are incarcerated may lag due to the limited number of services available, especially for special education.25 even a short time in the justice system can have a profound negative influence on youth. locked detention with harsh conditions and intensive supervision can also intensify symptoms for youth with serious mental health problems or a history of trauma and abuse.26 when compared to their peers, youth who spend time in detention centers were less likely to complete high school and less likely to find employment.27 in 2017, indiana’s rate of youth under 21 residing in juvenile detention centers was higher than the national average and higher than all its neighboring states.28 many youths enter the justice system with significant educational deficits.29 “the academic achievement levels of adolescents who are adjudicated as delinquent rarely exceed the elementary school level.”30 furthermore, the national estimate of youth in the justice system who have learning disabilities is as high as 70 percent.31 children with dbds have one of the highest risks of reoffending, and by nature of the behavior, this population of youth usually struggles academically.32 therefore, these youth stand to greatly benefit from a supportive and personalized education programs in addition to the children who have basic learning disabilities. this note clearly upholds the reasons why indiana must mandate the use of individualized education programs for youth in detention centers, specifically for children with dbds through passing legislation and adopting the pendleton model as the minimum standard. to support this claim, this note discusses in detail what both dbds and ieps are and highlights material on juvenile education systems and juvenile recidivism as a whole. more specifically, this note examines the relationship between academic performance and delinquency and how implementing ieps will help to reduce recidivism in delinquent minors. lastly, this note will analyze how indiana can and must effectively implement 22. id. 23. data report: youth in the justice system, supra note 16. 24. ind. code § 20-8.1-3-17 (2021). 25. data report: youth in the justice system, supra note 16. 26. id. 27. id. 28. id. 29. id. 30. id. 31. id. 32. id. 154 indiana health law review [vol. 21:151 ieps for institutionalized juveniles and the urgency of adopting such a necessary statute. ii. background a. disruptive behavior disorders 1. types of disruptive behavior disorders in minors disruptive behavior disorders (dbds) can seriously impact a child’s daily life.33 children with dbds display continued patterns of uncooperative and defiant behavior.34 they can respond hostilely to authority figures or can display indifference.35 children who suffer from dbds can assert behavior that impacts everyone around them, including teachers, peers, and family members especially.36 the most commonly diagnosed behavior disorders are oppositional defiant disorder (odd), conduct disorder (cd), attention deficient hyperactivity disorder (adhd), impulse-control disorder, and other unspecified disruptive disorders.37 children with these behavioral disorders also frequently exhibit stubborn, irritable, disobedient, and defiant behavior.38 children with conduct disorder show the same responses previously discussed, but will additionally tend to exhibit “physically aggressive and sometimes violent behavior and a tendency to actively and intentionally violate others' rights.”39 these behaviors are stressful to the individual and alarming to others.40 anger, defiant behaviors, and malevolence cause disruptions with relationships and can drastically affect school and work environments.41 individuals with dbds often experience conflict with adults and authority figures.42 those who are diagnosed with a dbd have a substantially higher likelihood of developing another mental illness in their lifetime, particularly, “anxiety disorders, mood disorders, substance abuse, and personality disorders.”43 fortunately, dbds are not necessarily chronic conditions.44 about 70% of children diagnosed with 33. disruptive behavior disorder, nationwide child. hosp. (2023), https://www. nationwidechildrens.org/conditions/disruptive-behavior-disorders [https://perma.cc/zs6w-8ml3]. 34. id. 35. id. 36. id. 37. id. (anxiety, depression, and bipolar disorder can frequently be considered behavior disorder in minors, as well, but because these usually stem from a more emotional side, they will not be specifically addressed in this review). 38. id. 39. id. 40. what are disruptive, impulse control, and conduct disorders, supra note 21. 41. id. 42. id. 43. id. 44. id. 2024] reduce juvenile recidivism 155 certain dbds, like oppositional defiant disorder, will resolve before they turn eighteen years old.45 2. identification and causes of disruptive behavior disorders in minors children with dbds are often diagnosed because they are showing various types of uncooperative behavior. these include: “arguing (especially about less important things), refusal to follow rules, deliberately annoying others, blaming others for misbehavior, and lack of respect for others, especially authority.”46 additionally, these children will behave in angry, resentful, and vindictive ways.47 in particular, children with oppositional defiant disorder often lose their temper, have aggressive behavior towards others, intentionally destroy property, lack remorse for their unacceptable behavior, and oftentimes run away from home.48 many adolescents are capable of displaying any one or numerous of these behaviors throughout their youth.49 however, children with dbds display them more often than others, frequently face discipline in school or at home, and frequently engage in conflicts with peers and family members.50 the root causes of dbds are unknown, but psychologists believe that various influences work together to contribute to these disorders.51 some of the factors that contribute or increase the likelihood of a child developing a dbd are: if the child suffers from mood disorders, adhd, and various other types of psychotic mental health disorders and/or if the parents suffer from substance abuse.52 furthermore, children who are raised in emotionally or physically abusive homes, children who are the recipients of overly harsh discipline, and children who are lacking adequate parental supervision are at a higher risk for developing dbds.53 3. impact on minors who suffer a lack of treatment for children who display symptoms of a dbd, it is essential for them to both be diagnosed and receive help from a qualified doctor. as previously stated, minors who have these disorders and are left untreated are at an increased risk for developing other mental disorders as an adult.54 children with dbds are further 45. id. 46. disruptive behavior disorder, supra note 33. 47. id. 48. id. 49. disruptive behavior disorders, bos. child. hosp. (2022), https://www.childrenshospital. org/conditions/disruptive-behavior-disorders [https://perma.cc/g4ta-5jhy]. 50. id. 51. id. 52. id. 53. id. 54. disruptive behavior disorders, the recovery vill. drug & alcohol rehab (2022), https://www.therecoveryvillage.com/mental-health/disruptive-behavior-disorder/ [https://perma.cc/2b5x-4vh5]. 156 indiana health law review [vol. 21:151 at risk of “problems at school, including failing and/or dropping out, self-harm or harm to others, substance abuse, criminal delinquency, and suicide.”55 their disorder can also become more severe, and frequently can lead to criminal/legal trouble, which lands minors in juvenile detention centers.56 having a dbd can be difficult enough in and of itself, but when you add juvenile institutionalization to the mix, creating even less access to the necessary help, the outcome can be catastrophic. 4. minors with disruptive behavior disorders and juvenile delinquency substantial analysis indicates the prevalence of psychiatric disorders and substance abuse among youth in correctional facilities that surpasses that of the general adolescent population.57 literature published by the american academy of pediatrics includes additional information that youth who are in contact with the juvenile justice system experience an abnormal frequency of mental health disorders with a high rate of dbds.58 furthermore, most minors would not be incarcerated unless they brought attention to themselves through their significant dbds.59 many youth who come in contact with the justice system have histories of trauma that develop into mental, emotional and behavioral disorders that are linked to future involvement in the system.60 additionally, juvenile mental health is compounded when left untreated and coupled with an abundance of substance abuse issues, leaving them ultimately defeated in their fight against recidivism before they have even been charged with their first crime.61 this endless cycle can be changed. it starts with more targeted trainings for facility professionals to identify mental health and dbds upon contact with the juvenile system.62 this in turn can identify the youth who would benefit from assistance in their education to prevent future reoffending.63 b. individualized education programs 1. ieps defined the indiana code defines individualized education programs as written statements developed for a child by a group that includes: a representative of the 55. id. 56. id. 57. paula k. braverman & pamela j. murray, health care for youth in juvenile justice system, 128 am. acad. of pediatrics 6, 1219-35 (2011). 58. id. 59. youth involved with the juvenile justice system, youth.gov (2021), https://youth.gov/ youth-topics/juvenile-justice/youth-involved-juvenile-justice-system [https://perma.cc/hsu4uj6l]. 60. id. 61. see id. 62. disruptive behavior disorders, supra note 49. 63. id. 2024] reduce juvenile recidivism 157 school, the child’s teacher, the child’s parent/guardian, the child (if appropriate), and a mental health professional if necessary.64 public schools are required to have ieps for each child who receives any form of special education or related services.65 these ieps must be truly individualized for each child who receives one and are intended to maximize and improve the child’s education based on that child’s specific needs.66 in order to have an effective iep, the personnel tasked with creating it “pool their knowledge, experience, and commitment to design an educational program that will help the student be involved in, and progress in, the general curriculum.67 the iep then “guides the delivery of the support and services for the student” and requires a sure amount of teamwork.68 2. writing and reviewing the iep when deciding what types of services a child needs, the iep team first looks at the child’s test results and how the child is currently doing in school.69 those results, combined with regular observations of the child in a learning environment, are taken together to determine goals. these goals will look at the child’s strengths and participation in extracurricular activities, as well.70 based on the discussion and development of these goals, the team will then write the child’s iep. as an example, for a child whose behavior interferes with learning, the iep team would create an iep with goals to effectively address that behavior to positively impact the child’s education.71 this may include “positive behavioral interventions and strategies that support the child’s needs in order to learn how to control or manage his or her behavior.”72 furthermore, a “behavioral intervention plan” can be agreed upon by the case conference committee and can be incorporated into a student’s iep.73 the indiana code describes a behavioral intervention plan as the following: the pattern of behavior that impedes the student’s learning or the learning of others, the purpose or function of the behavior, the position interventions to support or address the behavior, and if applicable, the skills that will be taught and monitories in an effort to change a specific pattern of behavior of the student.74 if the team chooses to implement a behavioral intervention plan as part of the 64. ind. code § 20-18-2-9 (2021). 65. id. 66. a guide to the individualized education program, supra note 19. 67. id. 68. id. 69. id. 70. id. 71. id. 72. id. 73. ind. code § 20-20-40-1 (2021). 74. id. 158 indiana health law review [vol. 21:151 child’s iep, they must write and incorporate the specifics into the plan.75 finally, the team then discusses the positive behavioral strategies and interventions that the child needs in order to manage his or her behavior.76 specific services that are decided upon must also have a statement to that effect written into the iep.77 3. implementing the iep once the iep is written, the next step is to implement the iep. this means that the student is provided with the special education and related services that are outlined within their specific iep.78 all the supplementary aids and services that the team has identified as being essential for the child to advance in their iep goals, which typically include progressing in their curriculum and participating in activities.79 teamwork plays an integral role in successfully carrying out the iep. sharing insights and expertise among all those involved in carrying out the iep will create the best results for the child.80 it may also be beneficial to have one person in charge of coordinating and monitoring the services that the child receives as a part of their iep to make sure it is being carried out appropriately.81 lastly, as the child continues through their education, it is important to monitor the child’s progress reports.82 ieps can always be modified as circumstances change, or methods prove ineffective.83 as laid out in the americans with disabilities act, indiana has a duty to provide youth with educational resources tailored to a student’s individual needs, especially when those youth are already at a disadvantage by their nature of being institutionalized.84 c. juvenile justice education systems are minors in juvenile detention centers entitled to education? specifically, are they entitled to special education? as a rule of thumb and unless laws of a particular state say otherwise, children who are detained are entitled to the same level of services and support in their education as children who are not.85 in the state of indiana, juvenile detention centers allow for school corporations to provide the facility with school materials for the grade level or courses in which the child is enrolled.86 this is available for children who are in detention facilities 75. id. 76. id. 77. id. 78. a guide to the individualized education program, supra note 19. 79. id. 80. id. 81. id. 82. id. 83. id. 84. americans with disabilities act of 1989, pl 336, u.s. statutes at large 104 (1990): 32778, https: //www.govinfo.gov/app/details/statute-104/statute-104-pg.327. 85. mccluskey, supra note 10. 86. ind. code § 20-26-5-38 (2021). 2024] reduce juvenile recidivism 159 for more than seven days.87 the school corporation is not required to provide school materials that have been requested only if the child is released or the facility or the parents request that the school no longer provide the materials.88 regardless of the laws, education is usually substandard within the walls of juvenile detention centers. all too frequently, classes are grouped by age instead of grade level and are being taught by unaccredited education programs and faculty who are akin to substitute teachers.89 moreover, even in the facilities that are trying to improve the education they provide, there are still significant restrictions on what can be brought inside.90 an example of this being that science classes cannot be taught without a majority of experiment instruments and other hands-on activities.91 homework is also rarely, if ever, assigned.92 additionally, in some jurisdictions, youth offenders receive neither schoolwork nor dedicated instruction while in solitary confinement.93 a study conducted from 2015 to 2016 showed that more than half of teenage offenders were regularly locked in solitary confinement.94 in particular, a new york justice center showed that more than 80% were regularly locked in solitary confinement and many spent up to twenty-three hours a day, seven days a week in dimly lit, tiny cells.95 “in lieu of regular schooling, they were given photocopied pages of a high-school equivalency workbook, which they were left to complete, or not, without supervision or review.”96 many of those children had ieps in special education prior to detention, however, and these plans were not being continued and the facilities were not making sure the children were where they needed to be academically.97 here, there were children who were already at risk for struggles with their education and the facilities made it worse by not giving them the basic educational support and attention that was needed.98 these circumstances are far from isolated. across the country juveniles experience gaps in their education that can leave them ill-prepared to return to school upon their release—if they return at all.99 additionally, a lack of coordination between schools and correctional facilities leads to various delays, including a delay in sending the student’s iep (if they already had one with their 87. id. 88. id. 89. mccluskey, supra note 10. 90. id. 91. id. 92. id. 93. see patrick mccarthy et. al., the future of youth justice: a community-based alternative to the youth prison model, natl. inst. of just. 2, 9 (2016), https://www.ojp. gov/pdffiles1/nij/250142.pdf [https://perma.cc/zs9g-syq9]. 94. id. 95. id. 96. id. 97. id. 98. id. 99. id. 160 indiana health law review [vol. 21:151 public school) to the correctional facilities, which causes a delay in the special services.100 even when the iep is passed along, the level of implementation of the iep doesn’t always meet the same level of services that were received by the child at their public school. mandating ieps will solve many issues of youth recidivism because it does not abandon the youth to the inadequacies of juvenile facility education, but rather provides an accountable system to maintain academic success. since 1975, individuals have filed over thirty class action lawsuits under the individuals with disabilities education act (idea) that challenge the educational services provided in detention centers.101 there are very few court opinions that have been published from these suits because they usually ended in settlements.102 however, some have been successful in broadly reforming juvenile correctional facilities.103 in johnson v. upchurch, a group of disabled students brought suit under the idea because no special education services were provided at the catalina mountain juvenile institution.104 the case settlement included broad reforms for juvenile detention centers throughout arizona.105 additionally, in andre h. v. sobol, a group of disabled students brought suit against a juvenile detention center because it did not comply with the idea.106 specifically, the suit alleged that the detention center refused to accommodate youth who had already been diagnosed as disabled and had been placed in a special education program before going to the detention center.107 once at the detention center, there were no evaluations, classifications, or placement of disabled youth in appropriate educational programs, regardless of their needs and what they were received in schools.108 many years later, the suit was settled, and a multidisciplinary team was formed to implement idea provisions at the detention center in the future.109 for many young offenders, education has always been a struggle. peter leone, a professor of behavior disorders at the university of maryland said that “kids who do poorly in school early on are more likely to be truant or to participate in the sorts of low-level criminal activity that sends many kids to 100. id. 101. see class action litigation involving special education claims for youth in juvenile and adult correctional facilities, natl. ctr. on edu., disability, & juv. just. (2005). 102. id. 103. id. 104. id., see also patricia puritz & mary ann scali, beyond the walls: improving conditions of confinement for youth in custody, off. of juv. just. & delinq. prevention 17-18 (1998) (discussing johnson v. upchurch. because the case was settled before trial, no reporter citation is available). 105. id. 106. peter e. leone et al., special education programs for youth with disabilities in juvenile corrections, 53 j. corr. edu. 46, 4 (2002). 107. id. 108. id. 109. id. 2024] reduce juvenile recidivism 161 detention facilities.”110 many young offenders never make it back to school at all. a booklet issued by the department of education notes that, while 90% of juveniles wish to enroll back in their traditional public school after being released, only one-third actually do.111 this is in part to a lack of reintegration support and resources provided to youth after they leave the facility and re-enter society.112 thus, the product is a higher percentage of adolescents who stay out on the streets, commit new offenses, and get themselves further into trouble.113 d. juvenile recidivism 1. characteristics of effective recidivism methods on minors general consistencies about program effectiveness indicate that the application of various practice principles is key to improving both institutional and community-based interventions.114 these practice principles include a focus on the most serious adolescent offenders, matching the needs of offenders with program orientation, and clear treatment strategies.115 additionally, any intervention must be provided with enough intensity to have an effect. research work with adult corrections indicates that “more time in a program ensures that an individual has sufficient exposure to a program’s effect, but also that the largest effect from program involvement will occur when sufficient resources are provided to the most high-risk individuals.”116 maintaining careful, quality program implementation has been acknowledged as one of the main factors linked to a reduction in reoffending for adolescent offenders.117 2. why are juvenile justice systems not working on some minors? for some youth offenders, too much program involvement can be as ineffective as too little program involvement. a study conducted by the office of juvenile justice and delinquency prevention concluded that “long-term juvenile incarceration does not decrease reoffending and may actually increase recidivism rates for lower-level youth offenders.”118 instead of long-term incarceration, community-based interventions that assist in reintegrating juveniles back into 110. mccluskey, supra note 10. 111. id. 112. id. 113. id. 114. richard j. bonnie et al., reforming juvenile justice: a developmental approach, the national academies press 157 (2013). 115. id. 116. id. at 158. 117. id. at 160. 118. brian heller de leon, study: long-term juvenile incarceration fails to decrease reoffending rates, ctr. on juv. & crim. just. (may 3, 2012), https://www.cjcj.org/news/ blog/study-long-term-juvenile-incarceration-fai ls-to-decrease-reoffending-rates [https://perma.cc/9fxq-b83r]. 162 indiana health law review [vol. 21:151 their lives have proven the most effective.119 those interventions include substance-abuse programs, behavior therapies, family therapies, mental health programs, and specialized education programs.120 there seems to be the least amount of focus on specialized education programs, which is why mandating the usage of ieps on the population of students who struggle the most with their behavior is a another solution to the problem. environmental factors such as economic conditions, population density, quality of education, and access to health care can also affect recidivism rates.121 specifically, characteristics of where youth reside, like in high-crime neighborhoods, can influence recidivism among juveniles, especially in drugrelated offenses.122 3. pre-trial juvenile detention increases risks of reoffending depending on certain jurisdictions, juveniles may be confined prior to trial to ensure they attend their court hearings.123 researchers have found that a stay in pre-trial detention, regardless of the length, increases the likelihood of recidivism in general.124 one specific study published in 2020 found that “a stay in pre-trial juvenile detention increases a person’s likelihood of felony recidivism by 33% and misdemeanor recidivism by 11%.”125 the study concludes that youth are thrown off course by even a single day in pretrial detention.126 these youth are separated from their families, schools, and communities with lasting effects before there has even been a determination of guilt.127 e. relation between academic performance and delinquency 1. peer influence on academic performance delinquent peer associations may result when a student comes to reject academic achievement and leans towards prosocial behavior as a reasonable value. when a child feels he or she is not receiving academic or emotional support from caring adults, this can lead to isolation and further plays a role in delinquent or aggressive behaviors.128 additionally, aggression has been 119. id. 120. id. 121. amanda mcmasters, effective strategies for preventing recidivism among juveniles, western or. univ 1, 18 (2015) https://digitalcommons.wou.edu/honors_theses/58/ [https://perma. cc/rdt7-n2tx]. 122. id. 123. sarah cusworth walker & jerald r. herting, the impact of pretrial juvenile detention on 12-month recidivism: a matched comparison, 66 sage j. 13-14, 1865 (2020). 124. id. 125. id. 126. id. 127. id. 128. national research council & institute of medicine, education and delinquency: 2024] reduce juvenile recidivism 163 suggested to explain the connection between peer rejection and delinquency, a common symptom of children who have dbds.129 not only is there a link between poor academic performance leading to delinquent peer associations, but certain peer associations can lead to poor academic performance. adolescents who experience peer rejection, gang involvement, alcohol or drug use by peers or association with peer delinquents are linked to a decrease in academic performance and an increase in delinquency.130 research studies have found that delinquent peer groups organize their social interactions and talk with one another around positive reinforcement “rule-breaking” discussions.131 this is called “deviancy training.”132 based on a specific study conducted on males aged thirteen and fourteen, this deviancy training predicted an increased probability of escalating disruptive behaviors, addictive substance use, delinquency, and violent behavior within the next two years.133 2. why do minors who do poorly in school have a higher likelihood of becoming delinquent? juveniles spend majority of their adolescence in their school environment. it makes sense that what their life is like at school would have a major effect on youth development. therefore, education comes with risk factors, which include truancy and dropping out, low academic achievement, learning disabilities, negative labeling by peers or teachers, and lack of parental involvement in the minor’s academics.134 regarding the association between underachievement and delinquency, “research supports the basic proposition that academic underachievement is positively associated with increases in delinquent behavior.”135 further, exploration in this area also indicates that minors with attention deficits were associated with both underachievement and delinquent behavior.136 studies have shown that children who exhibit early aggressive behavior may experience difficulties in the classroom.137 this result can also cause a child to receive disparaging assessments from teachers and peers and cause a child to turn to delinquency.138 moreover, children with one or more dbds can be summary of a workshop 14 (joan mccord et al. eds., 2000). 129. id. at 16. 130. mcmasters, supra note 121, at 22. 131. mccord, supra note 129, at 15. 132. id. 133. id. 134. mcmasters, supra note 122, at 23. 135. john p. hoffman, academic underachievement and delinquent behavior, 52 sage pub. 5, 19-20 (2018). 136. id. 137. mccord, supra note 129, at 13. 138. id. 164 indiana health law review [vol. 21:151 uncooperative, combative, and/or distracted, and their behavior affects their ability to learn and get along with others.139 subsequently, this leads to poor academic performance, anti-social behaviors, and poor impulse control.140 equally, delinquency can also be another manifestation of what got the child into trouble at school in the first place.141 f. evidence-based services for juvenile offenders over a number of years, there has been significant analysis that has enhanced the understanding of what interventions work with juvenile offenders.142 one of the most progressive policy reforms of recent years is “the drive for evidencebased practice, which focuses on effective treatments, services, and supports for children and families.”143 this subject has been addressed in the policy reforms of education, mental health, child welfare services, and juvenile justice systems.144 the best available research suggests that evidence-based programs and investments in services such as education and employment are the best ways to improve public safety while saving money.145 “although effective interventions have been developed and validated during the past twenty years, it remains the case that the vast majority of current services utilized in the juvenile justice system have not proven effective or simply have not been evaluated.”146 the impact of evidence-based programs is not quite where it was hoped to be. however, the rate of adoption and scale at which the intervention programs are implemented is reasonably similar to other areas of preventative science.147 139. carolyn reinach wolf et al., students with disabilities and the juvenile justice system: what parents need to know, autism spectrum news (2015), https://www.autismspectrumnews. org/students-with-disabilities-and-the-juvenile-justice-system-what-parents-need-to-know/ [https://perma.cc/gb7h-s8dj]. 140. id. 141. mccord, supra note 128, at 13. 142. randy borum, managing at-risk juvenile offenders in the community: putting evidence-based principles into practice, 19 j. contemp. crim. just. 1, 116 (2003). 143. mark w. lipsey et al., improving the effectiveness of juvenile justice programs: a new perspective on evidence-based practice, ctr. for juv. just. reform 1, 9 (2010). 144. id. 145. the costs of confinement: why good juvenile justice policies make good fiscal sense, just. pol. inst. 1, 19 (2009). 146. scott w. henggeler & sonja k. schoenwald, evidence-based interventions for juvenile offenders and juvenile justice policies that support them, 25 soc. res. child dev. soc. pol. rep. 1, 4 (2011). 147. delbert s. elliott et. al., evidence-based juvenile justice programs and practices: a critical review, criminology & pub. pol. 1, 1319-1320 (2020). 2024] reduce juvenile recidivism 165 iii. analysis a. how implementing ieps will reduce recidivism in delinquent minors individualized education programs serve as roadmaps to student success. the iep outlines the time, services, curriculum, and supplementary aids that the student needs to be successful in their education.148 incarceration during youth is a crucial point of intellectual development. children who already have dbds and who don’t have any support of an iep while in public school, will likely face poor academic performance.149 “a disabled youth may enter the ‘school-to-prison pipeline’ because of the lack of an individualized education plan (iep), bullying, and social absences.”150 furthermore, self-control and self-regulation issues themselves are associated with academic underachievement. this in turn “increases the likelihood of children experiencing peer rejection, gang involvement, alcohol or drug use, and association with peer delinquents.”151 youth who receive the appropriate support with their education while in detention centers will develop a sense of achievement. when youth experience academic achievement, it strengthens their mental health and their self-confidence.152 further, areas of self-control and self-regulation, maturity, and knowledge allow for adolescents to move toward being a productive member of society and decreases their likelihood of running into the law again.153 according to a comprehensive evaluation conducted by the rand team, inmates who participated in correctional education programs had a 43% lower change of recidivating than those who did not.154 juveniles with correctional education will also increase their likelihood of employment.155 strengthened ability for employment is nearly always linked to lower rates of recidivism because of the ability for an individual to support themselves without resorting to criminal activities and fosters independence and responsibility.156 in the pendleton facility in indiana, many students have received their high school diplomas behind bars, and the faculty work with the students to help them think about work opportunities after release, including resumes, cover letters, and college or job applications.157 according to statistics, the work is paying off. only 148. wolf et al., supra note 139. 149. id. 150. id. 151. id. 152. id. 153. id. 154. lois m. davis et. al., how effective is correctional education, and where do we go from here?, rand corp. (2014), https://www.rand.org/pubs/research_reports/rr564.html [https://perma.cc/n79b-avax]. 155. id. 156. see, education for youth under formal supervision of the juvenile justice system, off. of juv. just. & delinq. prevention 1, 1 (2019). 157. leo doran, inside indiana’s juvenile justice system, inside sources: education 166 indiana health law review [vol. 21:151 about one-third end up back in a juvenile facility and more than 80% are able to stay out of adult corrections.158 one of the adolescent students at pendleton who achieved his diploma and is set to be released soon told a reporter that “between the lack of distractions and being surrounded by an adults that are invested in his success, [he] explains that he has been able to focus on his schoolwork and has blossomed into becoming an avid reader.”159 b. costs and benefits of juvenile justice intervention in light of the compelling evidence that a variety of juvenile intervention programs significantly reduces one-year rearrests, it is worth it from a broader social policy perspective to encourage these types of programs.160 cost-benefit analysis identifies and measures the benefits and costs of a program. if the benefits exceed the costs, the program is proven economically efficient because the value of the output exceeds the cost of producing it.161 as a result, society is then economically and socially better off because of the positive outcomes that have been achieved as a result of the program’s impacts on juveniles.162 however, if costs exceed benefits, society is better off not operating the program and devoting those resources to other beneficial purposes.163 juvenile facilities were originally intended to be places for rehabilitation and support for adolescents to learn from their mistakes, while still holding them accountable for their actions.164 however, the rise in individuals at these facilities has caused overcrowding and a changed philosophy for some from one of rehabilitation to one of punishment.165 even in facilities without overcrowding, these youth often do not develop the social skills of self-control and conflict resolution as well as those who are never incarcerated. further, because the large number of overcrowded facilities often times create violent and chaotic environments for youth, those with behavioral health problems may only get worse while in detention and not better.166 additionally, youth who spend time in facilities “have higher recidivism rates; are less likely to naturally age out of illegal behavior; suffer from more mental illness and are at a higher risk of suicide, and they are less likely to succeed at education and employment” at the same level as those who remain in the community.167 (2017), https://insidesources.com/inside-indianas-juvenile-justice-system/ [https://perma.cc/3ffgfjd6]. 158. id. 159. id. 160. bonnie et al., supra note 114, at 167. 161. id. 162. id. 163. id. 164. the costs of confinement, supra note 145, at 9. 165. id. 166. id. at 18. 167. id. at 9. 2024] reduce juvenile recidivism 167 based on research by the justice policy institute, missouri’s department of youth services has become a model for juvenile justice systems. they have an emphasis on small facilities of no more than forty beds per facility and their focus on support and rehabilitation has had positive effects on the youth in their care.168 youth in these facilities are able to receive education in a purposeful way that allows them to meet educational benchmarks at similar rates to their peers in the community.169 this combined approach has allowed for recidivism rates of less than 10%.170 if children must be confined instead of being placed in communitybased programs, the missouri model is one of the most effective juvenile incarceration methods.171 research continually links education and continuing illegal behavior.172 locking up youth can interrupt the learning process even if there are educational opportunities behind bars.173 there is rarely a fluid transition from a juvenile facility back to education in the community.174 lack of adequate education during confinement creates barriers to employment that limit a person’s ability to positively contribute to society upon release.175 one of the recommendations by the justice policy institute is to invest in policies that increase employment, educational attainment, and treatment for those who need it.176 the alliance for excellent education reported that “a 5% increase in male high school graduation rates would produce an annual savings of almost $5 billion in crime-related expenses.”177 clearly, by focusing on a supportive education that continues even when incarcerated, and encourages youth to succeed towards employment, the benefits outweigh the costs with requiring ieps in juvenile detention facilities. c. possible challenges the only state supreme court that has directly challenged the education provided in juvenile detention under its state constitution and statutes is the washington supreme court in tunstall v. bergeson.178 even though the results in tunstall are not binding on other states, it still gives an insight into the mindset that courts might take in approaching this topic. in tunstall, a class of juvenile inmates challenged a lack of education during their incarceration as unconstitutional and as a violation of the basic education act (bea).179 the trial 168. id. 169. id. 170. id. 171. id. 172. id. at 15. 173. id. at 19. 174. id. at 9. 175. id. 176. id. 177. id. 178. tunstall v. bergeson, 141 wash. 2d 201, 5 p.3d 691 (2000). 179. wash. rev. code §§ 28a.150.200–.150.310 (2006). 168 indiana health law review [vol. 21:151 court granted summary judgment for the inmates, but the washington supreme court reversed, finding no violation of the inmates’ constitutional rights.180 it is also important to note that these youth were incarcerated at an adult facility not a juvenile detention facility, despite being under 18 years old.181 the court held that these inmates had a constitutional right to education under article ix of the washington constitution.182 however, the court rejected the plaintiff’s challenge, because, although the education may not have been adequate, the state still had provided some educational services to inmates.183 the bea statute required that the correctional facility provide education to help inmates achieve a high school diploma, and the court held that this statute was sufficient enough on its face.184 it is important to note that the court explicitly rejected the argument that the children had forfeited their right to education by engaging in the conduct that resulted in their incarceration.185 ultimately, the court held that “individuals under age 18 incarcerated in adult washington state department of correction (doc) facilities have a constitutional right to public education,” and that this right was satisfied by the bea.186 on its face, this ruling can be considered significant, since the court held that children have a constitutional right to education, even while incarcerated. yet, the problem remains on what is considered adequate. iv. the future of juvenile justice education a. a statute adopting the requirement of ieps for minors in detention centers with disruptive behavior disorders for the state of indiana to adopt a uniform, effective program to ensure youth with dbds receive the educational support they need, the state legislature would need to effectuate legislation that mandates following a pattern of screening and developing educational support for all juveniles in state detention facilities. a hypothetical statute or structure of important aspects to add to a statute would state the following: 1. faculty shall be employed at each states juvenile detention facility who are qualified by the state to be a teacher and shall be qualified in the implementation and understanding of individualized education programs. if the teacher does not already have a license, the facility will be responsible for job training in order to be qualified. 2. juveniles who will be staying at a detention facility for at least sixty 180. tunstall, 5 p.3d at 696, 702-04, 708. 181. id. at 694. 182. id. at 702. 183. id. 184. id. at 702-03. 185. id. at 701. 186. id. at 694. 2024] reduce juvenile recidivism 169 days shall receive a mental health intake at the beginning of their detention. 3. those diagnosed with a disruptive behavior disorder (dbd) will be flagged and within 7 days of their arrival, shall start the development of an individualized education program (iep). 4. the facility's iep and teaching faculty and the juvenile’s previous school (prior to detention) shall work together to create an individualized education program for the juvenile, and shall begin no later than fifteen days after the child’s arrival at the facility. 5. for any juvenile who has a lengthened stay at a facility—every two or three months, the individualized education program shall be reviewed and the progress of the juvenile assessed. the iep shall be adjusted as needed, as the juvenile progresses and develops in their education. 6. upon the juvenile’s release, the iep and all documents used for the education and implementation of the plan shall be provided to the school at which the child will be enrolled. simple implementation of a statute will not be enough, however. having supplemental aids to coincide with the statute will help to effectively carry out this solution. maintaining plans for enforcement, plans for integration of the ieps, and plans to continue to re-evaluate and monitor the progress will be essential to having the best possible results for juveniles. the following sections delve into these plans further, as well as a model that all of indiana should look to as the standard. b. enforcement through assessment and intake health and social services have come to rely more significantly on research and analysis-based screening methods.187 these methods include checklists that identify specific problems and their severity for further assessment.188 for example, one method assesses how ready and equipped an individual is to leave a restrictive environment.189 another method assesses high-risk individuals of their imminent serious violence, and how this can be avoided in the institutional environment.190 furthermore, detention screening instruments are frequently implemented to assess a youth’s risk of failing to appear in court or of committing another crime upon release.191 mental health screening instruments are also becoming standard practice with youth when they initially arrive at the facility to assess the minor’s mental state.192 187. bonnie et al., supra note 114, at 145. 188. id. 189. id. 190. id. 191. id. at 146. 192. id. at 145. 170 indiana health law review [vol. 21:151 in particular, there are juvenile assessment instruments designed to detect how intervention methods can be addressed by identifying the youth’s needs.193 all too frequently, the conduct that leads to their involvement with the juvenile justice system relates to unknown or underdiagnosed disability or mental health disorder.194 implementing and coordinating early screening, assessment, and intervention strategies as early as possible is key to determine whether having the support of an iep is essential. the division of youth services through the indiana department of corrections conducts initial intakes on youth sent to their units.195 these intakes include assessments for “criminogenic needs, mental health needs, educational, vocational, and aftercare needs.”196 however, neither the division of youth services nor the indiana juvenile justice plan for 2021-2024 specifically identify their approach to the components of the intake process.197 therefore, the research analyzed for this note centered on the methods of intake through adult prisons to determine the recommendation for specific juvenile intake components. analysis of a juvenile’s medical, mental, and educational needs should constitute a significant portion of the initial intake assessment and should begin as soon as a youth is subject to detention at a juvenile detention center. these should include, medical screening, physical examinations, substance abuse tests, mental health and psychological screenings, and academic achievement tests.198 nationwide, these tests are required to be administered in 96% of states in adult prison facilities and should be required to be administered in juvenile detention facilities as well, if they aren’t already.199 also, as part of the mental health and psychological screenings, juveniles should specifically be screened and assessed for dbds. those who have a positive indication of both dbds and learning disabilities should be flagged to receive an iep assessment after intakes. based on the results of the various screenings and tests through the intake process, classification staff should compile a profile for each individual 193. id. 194. youth with undiagnosed or mistreated disabilities, coa. for juv. just., https://www. juvjustice.org/our-work/safety-opportunity-and-success-project/national-standards/section-iprinciples-responding-2 [https://perma.cc/6nty-lpky] (last visited mar. 26, 2023). 195. treatment programming and mental health services, ind. dept. of corr. – div. of youth servs. (2023), https://www.in.gov/idoc/dys/juvenileprograms/#:~:text=after%20being% 2 0 c o mmi t t e d % 2 0 b y% 2 0 a , % 2 c % 2 0 vo cat io n a l%2 c%20aft e r c a r e % 2 c % 2 0 e t c [https://perma.cc/4u6f-757g]. 196. id. 197. id.; see also ind. crim. just. inst., ind. juvenile just. plan 2021–2024 (aug. 3, 2021). 198. see prisoner’s intake systems: assessing needs and classifying prisoners, u.s. dept. of just. natl. inst. of corr. (2004), (this source was used to analyze what methods worked and how prison intakes typically are done to develop ideas for juvenile detention centers in indiana’s intake system), https://info.nicic.gov/nicrp/system/files/019033.pdf [https://perma.cc/6vqwxj2h]. 199. see id. 2024] reduce juvenile recidivism 171 juvenile.200 these classification profiles will help to determine (among other program and treatment needs) those who would benefit from an iep in their education at the facility. these profiles and needs assessment classifications should be able to be shared among facilities, courts, and other correctional agencies the juvenile comes in contact within the future.201 through utilizing a mental health intake assessment that includes dbds, indiana will be able to effectively determine if a child would benefit from the educational support of an iep. c. quality education that integrates the ieps according to the division of youth services, after intake, youth are assigned a correctional counselor/case manager at their facility who manages their treatment plan and coordinates the usage of programs.202 typically, these programs focus more on substance abuse and mental health treatment, learning to regulate their emotions, better decision-making support, and reintegration with their families.203 additionally, an emphasis on core cognitive-behavioral programs are usually a part of a juvenile’s rehabilitation programs at their facility.204 however, there seems to be a lack of information on what the precise educational support will look like for juvenile offenders, based on information provided by the division of youth services and the indiana juvenile justice plan for 2021-2024.205 youth in correctional facilities are just as entitled to an education as their peers who are not incarcerated.206 yet, they aren’t receiving the services they need, which in part stems from a lack of training for teachers in correctional facilities, and improper record transfers, to name a few.207 additionally, there are a larger portion of youth with special needs who qualify for services who are in detention centers, but less faculty and resources available to them than public school systems.208 this disproportionality and lack of qualified staffing is a large part of the reason why juveniles aren’t receiving the educational help they need.209 this is further compounded by the fact that nearly one half (48%) of incarcerated youth are functioning below their appropriate grade level.210 200. see id. 201. see id. 202. ind. crim. just. inst., ind. juvenile just. plan 2021–2024, supra note 197. 203. id. 204. id. 205. treatment programming and mental health services, supra note 195. 206. allison thibault, using hindsight evidence when evaluating ieps for youth with disabilities in adult correctional facilities, 31 geo. mason u. c.r. l.j. 1, 157 (2021). 207. id. 208. see id. at 161. 209. id. 210. id. at 163. 172 indiana health law review [vol. 21:151 additionally, youth in public schools usually spend six hours a day in school, whereas fewer than half of incarcerated youth spend that amount of time in school while in detention centers.211 having these procedures, or lack thereof, is diminishing the goals of the individuals with disabilities education act, the equal protection clause of the fourteenth amendment, and the civil rights act of 1964.212 it is significantly difficult balancing the safety and rehabilitation of juveniles with their quality of education.213 yet, there are still effective methods to ensure that ieps are utilized and integrated in effectives ways. having staff and teachers who are trained either by having an indiana teaching license or by receiving on the job training that effectively equates to a license, coupled with specialized iep and dbd, will be essential to making this whole process work. the teachers can meet with the juvenile’s case worker, any psychological therapists or other program specialists the juvenile has, and parents (if appropriate) to create the ieps. furthermore, incarcerated youth should be receiving thirty to thirty-five hours of learning per week just like their non-incarcerated peers are receiving, or else risk falling behind. this can be broken up into segments that include evening and weekend learning in order to reach that number of hours. the amount of time spent in the classroom and learning is imperative, as children with dbds may require additional time to master their academics due to their iep plans. d. continuing to re-evaluate and monitor academic progress integrated treatment programs must be effective in reducing recidivism or they will have little value to the juvenile justice system. adolescents do not have a fixed set of characteristics and are constantly evolving.214 relying on one initial evaluation will create inaccurate assessments of the likelihood of reoffending and is a poor indicator of later outcomes.215 the federal appellate courts have varying views on how ieps should be evaluated, causing further confusion in an already complex program.216 the eighth circuit has the best approach. this circuit interprets academic progress as an “important factor in evaluating an iep’s appropriateness and creates an evaluation standard that ensures that an iep must be responsive to an individual’s academic and behavioral needs.”217 the seventh circuit, which is the jurisdiction that the entirety of indiana is in, does not hold this view. the seventh circuit has a more limited involvement when evaluating whether an iep is appropriate after it has been implemented.218 progress monitoring is essential to evaluating the appropriateness of a 211. id. at 164. 212. id. 213. id. at 173. 214. bonnie et al., supra note 114, at 178. 215. id. 216. thibault, supra note 206, at 171. 217. id. at 166. 218. id. at 167. 2024] reduce juvenile recidivism 173 juvenile’s iep plan, but many iep teams fail to develop or include plans to monitor progress or simply do not know how to appropriately measure the child’s progress.219 indiana is one of those places.220 according to a report conducted by the indiana department of education in 2022, there were hundreds of noncompliance violations by public schools for children with ieps.221 that report indicated that some schools were not establishing ieps as required or not following up with their progress correctly.222 with indiana public schools struggling to have satisfactory ieps that comply with idea, juveniles in correctional facilities are suffering all the more.223 there are less people focusing on these juvenile’s education and thus they are getting the brunt end of the situation. now more than ever, not only implementing the ieps, but having effective training for teachers and faculty within the juvenile correctional facilities is necessary. the most useful and valid assessments on adolescents are when they focus on short-term outcomes and goals that are as evolving as the youth themselves.224 thus, in order to be most informative and effective, juveniles in indiana must have assessments and screenings done more regularly to consider all the influential factors in their lives.225 the best approach would be to implement ieps in juvenile facilities with the same goals and intentions as how idea requires them to be administered in public schools. first, the student’s current level of performance is determined by the iep team, followed by deciding several goals that will take place over time.226 there are several dates and duration of services that are included in the goals section of the iep, as well as specifics on monitoring progress.227 all too frequently there are considerable failures in reporting a student’s progress within their iep, so this is the most crucial step in maintaining a successful plan.228 therefore, the iep team who makes the iep, especially teachers, should review the juvenile’s progress every 2-3 months at minimum. if the team conducts assessments as frequently as this, they will be able to make any necessary changes or updates to the plan for moving forward. it will also be a great indicator if any methods included in the iep plan work better or worse than others. additionally, since those with dbds in juvenile detention facilities would be required to receive an iep, it would be ideal to also include a behavior 219. susan k. etscheidt, progress monitoring: legal issues and recommendations for iep teams, 38 teaching exceptional child. 3, 56 (2006). 220. angela brauer, data shows hundreds of special education plan violations in indiana, cbs4 (july 14, 2022), https://cbs4indy.com/news/data-shows-hundreds-of-special-education-planviolations-in-indiana/ [https://perma.cc/ga7k-g6um]. 221. id. 222. id. 223. see id. 224. bonnie et al., supra note 114, at 178. 225. id. 226. etscheidt, supra note 219, at 56. 227. id. 228. id. at 57. 174 indiana health law review [vol. 21:151 intervention plan within each iep. even idea requires iep teams to consider including behavior intervention plans in cases where a child’s behavior impedes his or her learning progress, and this includes children with dbds.229 the goal should be to develop proactive, preventative approaches to behavioral problems and to monitor and determine the effect of the planned interventions.230 because the juvenile’s behavior and learning are intertwined, including the behavior intervention plans and assessing this at the same 2-3 month minimum is crucial to the student’s success. e. the pendleton model one facility in indiana, pendleton juvenile correctional facility, has actually worked on utilizing ieps with juveniles at their facility with a stronger focus on quality education as their form of rehabilitation.231 pendleton has a school building within the facility that was purposefully designed to have the look and feel of a regular public school.232 the teachers are also required to have special education certifications.233 a good portion of the juveniles in the school have ieps, their good behavior is rewarded with comfort food and extra privileges, and if they act out in class they are sent to the counselor’s office.234 additionally, they have significantly cut down on their use of solitary confinement and focus more on leading adolescents to make the right decisions.235 the main full-time teacher is assigned a caseload of students to work with and get to know.236 this teacher is responsible for advocating on their behalf with other teachers and meets with them at least once per month.237 additionally, the guards and administrators refer to the boys living there as “students” instead of any other term equating to “prisoner.”238 the term is all the more appropriate because the students spend so much time in class—their school year runs from july 1st to june 30th, with no breaks.239 a former counselor at pendleton who is now an executive director explained that to leave pendleton, must maintain at least a 4.0 behavioral average.240 she stated that, “we don’t like to think in terms of punishment here, more consequences. ultimately, it’s about leading them to make the right decisions.”241 the administrators at pendleton 229. id. at 58. 230. id. 231. doran, supra note 157. 232. id. 233. id. 234. id. 235. id. 236. id. 237. id. 238. id. 239. id. 240. id. 241. id. (quoting a direct quote from one of the students at pendleton discussed in this article). 2024] reduce juvenile recidivism 175 prefer the students transfer their credits they earn back to their home school districts, but when that’s not possible, they usually sit for high school equivalency exams to determine academic placement.242 for any student who hopes to attend community college or obtain employment upon release, the faculty help them put together college or job applications, resumes, and cover letters.243 the youth respond well to the attention from an adult role model who seem to care about their success. overall, the program seems to work for many students.244 this is a phenomenal model that would be a basis for recreation in all juvenile detention facilities in indiana and even more so nationally. v. conclusion this educational success while incarcerated can only be achieved if the education is adequate. kids who do poorly in school early on are more likely to be truant or to participate in the sorts of low-level crimes that send many kids to detention facilities.245 this is a really big issue that speaks volumes about the vulnerability of youth with needs in a judicial system that “is not very responsive or does not acknowledge the fact that . . . kids with disabling conditions are much more likely to be detained. and then, once they’re detained, they’re more likely to be committed and kept in confinement for longer periods of time.”246 not all the population in indiana is aware of this problem, though, and without having experienced it themselves or having children involved within the justice system, it may be hard to grasp the desperate need for reform still. therefore, pushback will be expected, especially involving legislation that involves increased spending. in order to implement these changes, more faculty, more training, and qualified teachers will be needed. however, this solution has long lasting effects, substantial results, and is absolutely viable in indiana, as seen in the pendleton model. if incarcerated youth have disabilities that affect their learning abilities, they need individualized educational plans to ensure their educational needs are still being met. having plans in place that ensure juveniles can succeed academically are also more likely to find employment when released from prison/juvenile detention centers. furthermore, successful correctional education reduces recidivism among juvenile offenders since it provides them with opportunities to change their personal behavior and values, and their higher rates of academic competencies are associated with lower rates of recidivism. 247 by effectively addressing these issues, other issues within the criminal justice system will be 242. id. 243. id. 244. id. 245. mccluskey, supra note 10. 246. id. 247. sonia pace, from correctional education to school reentry: how formerly incarcerated youth can achieve better educational outcomes, 23 texas j. civil lib. 2, 127-143 (2018). 176 indiana health law review [vol. 21:151 mitigated. when combined with other interaction methods such as mental health and substance abuse resources, indiana can effectively and continuously reduce recidivism rates among juvenile offenders. it may take some time to see the effects, but we owe it to our youth to make these changes the solution. keep saying gay: how nationwide “don’t say gay” bills violate the first amendment, chill protected speech, and hinder public health outcomes hunter foist* i. introduction on june 12, 2016, a man walked into a popular gay dance club in orlando, fl and opened fire.1 at the time, the pulse shooting was called the deadliest mass shooting in united states history, with at least forty-nine dead and dozens more injured.2 this horrific hate crime targeted directly at the lgbtq community during pride festivities came after the supreme court handed down its landmark marriage equality decision in obergefell v. hodges,3 increasing queer visibility throughout the country.4 large swaths of the country came together to support the victims of the pulse nightclub shooting, with local and national government officials issuing statements, vigils across the country, and the president and vice president of the united states meeting with survivors and victims’ families.5 this outpouring of support after pulse was in stark contrast to the complete lack of response from government or public officials after the 1973 arson attack on the upstairs lounge in new orleans, the previously most deadly incident targeting the lgbtq community.6 after thirty-two people, among them pro-lgbtq church-goers, were killed in the fire, local and state officials almost entirely ignored the event.7 local churches even refused to host funerals for the victims of this arson.8 while both tragedies showcase clear targeting of the lgbtq community, the government’s response after the pulse shooting showed a shifting of the tides toward acceptance, understanding, and recognition. federally, it appeared that the united states was making positive progress for the queer * j.d. candidate, indiana university mckinney school of law, b.a. in secondary english education and b.a. in advertising from indiana university bloomington. the author extends his sincerest gratitude to professor brad desnoyer and professor stevie pactor for their encouragement and advisement throughout the writing process. the author also wishes to thank his family, friends, and boyfriend for their unwavering and continued support. 1. bonnie j. morris, a brief history of lesbian, gay, bisexual and transgender social movements, am. psych. ass’n. (oct. 6, 2022), https://www.apa.org/pi/lgbt/resources/history [https://perma.cc/sra8-vgl5]. 2. id. 3. obergefell v. hodges, 576 u.s. 644 (2015). 4. michael ray, orlando shooting of 2016, britannica (oct. 6, 2022), https://www. britannica.com/event/orlando-shooting-of-2016 [https://perma.cc/yj3w-823y]. 5. morris, supra note 1. 6. ray, supra note 4. 7. id. 8. id. 178 indiana health law review [vol. 21:177 community.9 however, at the state, local, and municipal levels, anti-lgbtq sentiment continued to foment, spurned in large part by the religious right.10 this anti-lgbtq sentiment continues to seep into violent acts, most recently with the mass shooting at club q in colorado springs on november 19, 2022.11 the attacker at club q entered during a drag queen’s birthday celebration, opening fire until he was wrestled to the ground by other patrons.12 the attacker killed five people and injured seventeen others in a place meant to be a safe space for the lgbtq community.13 the attacker claimed that his mother forced him to go to club q and that he was inspired to commit the attack by a neo-nazi white supremacist training video.14 prosecutors were able to show enough evidence to convict the attacker on murder and hate crime charges, pointing to evidence of a “distaste for lgbtq.”15 this distaste included an online message of a rifle scope over the pride flag and use of gay slurs to refer to others while online gaming.16 this violent attack is one of many against the lgbtq community in recent years, and these acts coincide with an uptick in anti-lgbtq legislation like the one at issue in this note.17 in every documented culture throughout history, historians tend to agree that there is evidence of homosexual activity and same-sex love.18 however, there is also evidence of severe persecution of lgbtq people by state, church, and medical authorities throughout history.19 this should come as no surprise to any reader of this note, as homophobia, transphobia, and general “otherness” are entrenched in each of our institutions, churches, and governments. the two attacks described above come after centuries of persecution, and while marriage equality and more queer visibility show positive progress toward lgbtq acceptance, institutions, churches, and governments are fighting to reduce visibility and reverse all positive progress made. these institutional and governmental attempts to restrict the rights and visibility of queer people, and 9. id. 10. sophie bjork-james, christian nationalism and lgbtq structural violence in the united states, 7 j. religion & violence 278, 279 (2019) (discussing how nationalist movements justify their own moral positions through framing privileged groups as victims). 11. colleen slevin, colorado gay club shooting suspect charged with hate crimes, ap news (dec. 6, 2022), https://apnews.com/article/crime-shootings-colorado-hate-crimes-springsb9be567920a55986c57af59535ac9f61 [https://perma.cc/3wqb-2jbs]. 12. id. 13. id. 14. id. 15. id. 16. id. 17. liz elting, in dialogue: sarah kate ellis, president and ceo of glaad, on the power of media and lgtbq representation, part 2, forbes, (feb. 23, 2023), https://www.forbes.com/ sites/lizelting/2023/02/23/in-dialogue-sarah-kate-ellis-president-and-ceo-of-glaad-on-the-power-ofmedia-and-lgtbq-representation-part-2/?sh=adda5fc52a19 [https://perma.cc/cjl9-t6h6]. 18. morris, supra note 1. 19. id. 2024] keep saying gay 179 especially queer youth, across the country come to a head in florida with what has been dubbed the “don’t say gay” bill.20 ii. the issue & background information in early 2022, florida governor ron desantis signed the “parental rights in education” bill.21 the bill states, “[c]lassroom instruction by school personnel or third parties on sexual orientation or gender identity may not occur in kindergarten through grade 3 or in a manner that is not age-appropriate or developmentally appropriate for students in accordance with state standards.”22 opponents quickly labeled it the “don’t say gay” bill.23 in addition to preventing classroom instruction on lgbtq topics, the bill allows for an extreme and likely chilling effect: the ability of parents to sue a school district if the policy is violated.24 florida’s law took effect on july 1, 202225, and at least twelve other states have considered new legislation that mimics florida’s law, each generally seeking to prohibit any classroom mention or discussion of sexual orientation or gender identity.26 florida may be the first to pass a law like this in the past few years, but this is certainly not the first attempt to restrict discussions of lgbtq topics in the classroom.27 similar laws, dubbed by lgbtq activists as “no promo homo” laws, have been proposed and enacted in the past several decades in states wishing to forbid a school from saying positive things about queer people in classrooms.28 nine states passed “no promo homo” laws in the wake of the hiv/aids epidemic.29 three states repealed the laws, and south carolina’s law was overturned in the u.s. southern district of south carolina after failing to meet even rational-basis review under the equal protection clause.30 of the five 20. jaclyn diaz, florida's governor signs controversial law opponents dubbed 'don't say gay', npr (mar. 28, 2022), https://www.npr.org/2022/03/28/1089221657/don’t-say-gay-floridadesantis [https://perma.cc/3j83-4yvt]. 21. id. 22. h.b. 1557, 2022 leg., 124th reg. sess. (fla. 2022) (enacted). 23. diaz, supra note 20. 24. h.b. 1557, 2022 leg., 124th reg. sess. (fla. 2022) (enacted). 25. diaz, supra note 20. 26. dustin jones & jonathan franklin, not just florida. more than a dozen states propose so-called 'don't say gay' bills, npr (apr. 10, 2022), https://www.npr.org/2022/04/10/ 1091543359/15-states-don’t-say-gay-anti-transgender-bills [https://perma.cc/s7mw-l5e9]. 27. id. 28. id. 29. “no promo homo” laws: harmful and outdated, equality texas, (sept. 2, 2022), https://www.equalitytexas.org/no-promo-homo-laws/ [https://perma.cc/gts8-zlfh]. 30. id. 180 indiana health law review [vol. 21:177 states with these laws still in effect, four still limit discussion of lgbtq issues to sex education courses.31 florida’s bill limits classroom “instruction or discussion” of gender identity and sexual orientation, which has led to some florida teachers removing swaths of books containing even a passing mention of lgbtq characters or ideas.32 some of the books removed included “twilight” and “harry potter”,33 which are common middle-early childhood reads.34 these books were not removed from a classroom library in a k-3 classroom, as the original bill targeted, but rather a high school special education classroom.35 these actions are massively consequential and reach expression and ideas far beyond the “parental rights in education” bill’s written purpose.36 “don’t say gay” bills have been in the news for much of 2022 and 2023, with florida taking the bulk of the spotlight due to a brazen leader keen on more than just being governor of florida. in the same state where a man opened fire in a gay night club in 2016 specifically targeting lgbtq people, their state government seeks to limit speech about lgbtq people entirely, as if our existence does not warrant a passing mention. desantis and others in his state government are speaking to a riled up, largely religious, national base, and he’s chosen a culture war based on “protecting children” and “preserving parental rights.” his sentiment is not new, but the passage of the bill and the effects we are seeing in the 2022-2023 school year are. indiana state legislators recently introduced house bill 1608, a bill that censors conversation about lgbtq people and issues in public schools.37 the bill also targets transgender students by forcing teachers and administrators to “out”38 students to their parents if a student changes their gender identity or pronouns.39 the bill was amended to limit discussion of lgbtq issues grades k3 to sexual education courses, something that is uncommon in early education classes.40 indiana house committee members voted 9-4 to send the bill, sponsored by republican michelle davis, to the full house for consideration.41 supporters 31. id. 32. jo yurcaba, florida teachers navigate their first year under the 'don't say gay' law, nbc news, (sept. 1, 2022), https://www.nbcnews.com/nbc-out/florida-teachers-navigate-firstyear-don’t-say-gay-law-rcna43817 [https://perma.cc/aa9r-sja6]. 33. despite the harry potter series having no explicit reference to lgbtq characters or ideas. 34. yurcaba, supra note 32. 35. id. 36. h.b. 1557, 2022 leg., 124th reg. sess. (fla. 2022) (enacted). 37. h.b. 1608, 123rd gen. assemb., first reg. sess. (ind. 2023). 38. “out” in this context means forcing someone to disclose their sexuality or gender without their consent. 39. h.b. 1608, 123rd gen. assemb., first reg. sess. (ind. 2023). 40. arleigh rodgers, indiana ‘don’t say gay’ bill pivots to kids’ gender identity, ap news, (feb. 25, 2022, 10:54 am), https://apnews.com/article/sex-education-teaching-indianagender-711a50c7b385dae68795889d07c2bcdc [https://perma.cc/37au-suvg]. 41. id. 2024] keep saying gay 181 of the bill argue that h.b. 1608 would “empower parents to choose how their children are raised.”42 indiana’s bill, as amended, provides: “[t]hat a school, an employee or staff member of a school, or a thirdparty vendor used by a school to provide instruction may not provide any instruction to a student in kindergarten through grade 3 on human sexuality. provides that a school employee or a school staff member is not prohibited from responding to a question from a student regarding certain topics. provides that an employee or staff member of a school may only use a name, pronoun, title, or other word to identify a student that is inconsistent with the student's sex if the student, who is an adult or an emancipated minor, or the parent of an unemancipated minor requests in writing the use of a specific name, pronoun, title, or other word to identify the student.”43 the indiana house of representatives passed h.b. 1608 on february 23, 2023 with little debate.44 indiana’s legislation is modeled off of florida’s “don’t say gay” bill,45 and joins the over 250 anti-lgbtq bills introduced in 2023 thus far.46 these damaging bills stop speech, chill speech, and most importantly, negatively impact the lives and health of lgbtq people, particularly lgbtq youth.47 florida’s attempt to chill speech has been called “unconstitutionally vague” by opponents of the bill due to its implications on the first amendment rights of both teachers and students alike.48 opponents to indiana’s bill and other bills across the country echo the same sentiments.49 a chilling effect on speech occurs when a regulation is so vague, overbroad, or uncertain that people are unsure if they can speak at all for fear of government sanctions.50 famously, teachers and students do not lose their constitutional right to free speech when they enter a school building or classroom.51 florida’s “don’t say gay” bill and others like it unconstitutionally restrict both teacher and student speech, and the statute maliciously violates the first 42. id. 43. h.b. 1608, 123rd gen. assemb., first reg. sess. (ind. 2023). 44. emily longnecker, indiana gender identity bill passes indiana house, wthr, (feb. 23, 2022), https://www.wthr.com/article/news/politics/indiana-house-bill-1068-don’t-say-gaypasses-house/531-9a747edf-a1f9-44f2-805d-1ae70ea60c5e [https://perma.cc/n887-h2kp]. 45. id. 46. elting, supra note 17. 47. id. 48. ian millhiser, the constitutional problem with florida’s “don’t say gay” bill, vox (mar. 15, 2022), https://www.vox.com/2022/3/15/22976868/don’t-say-gay-florida-unconstitutionalron-desantis-supreme-court-first-amendment-schools-parents [https://perma.cc/7qtu-v4dq]. 49. rodgers, supra note 40. 50. note, the establishment clause and the chilling effect, 133 harv. l. rev. 1338 (2020). 51. tinker v. des moines indep. cmty. sch. dist., 393 u.s. 503, 506 (1969). 182 indiana health law review [vol. 21:177 amendment. per settled constitutional jurisprudence, this restriction on speech essentially amounts to a prior restraint, or restricting speech before it is uttered, and as such, is presumptively unconstitutional.52 as this note will discuss and argue, by not allowing students to engage with and receive important ideas and knowledge about sexual orientation and gender identity, florida is leading the charge in creating unsafe environments for lgbtq students. inevitably, florida’s “don’t say gay” bill and copycat bills across the country, including indiana, will lead to worse public health outcomes for lgbtq people across the country. this note will argue how florida and other copycat “don’t say gay” bills are unconstitutionally vague, restrict protected speech and expression by students and teachers alike, unduly restrict access to protected ideas, and create hostile environments for lgbtq students and teachers leading to poor public health outcomes for lgbtq individuals across the country. it will also argue that discussion of sexuality and gender is not only appropriate for all students, but it should also be required in each grade level with varying degrees of depth and explanation. iii. analysis a. the first amendment & schools “the vigilant protection of constitutional freedoms is nowhere more vital than in the community of american schools.”53 rather than promoting the free expression of ideas, florida’s “don’t say gay” bill expressly restricts classroom discussion of sexual orientation and gender identity in kindergarten through third grade classrooms—or “in a manner that is not age appropriate or developmentally appropriate for students in accordance with state standards.”54 within months of being passed, this bill is having far reaching impacts on speech for students and teachers in every grade level in florida, and the impact of florida’s discrimination of lgbtq content in the classroom is being felt across the united states.55 the first amendment has drawn consistent scrutiny in educational settings. every branch of government has grappled with its application for students, teachers, and books. florida’s “don’t say gay” bill calls for renewed scrutiny of how the first amendment is applied in schools, what rights students and teachers have, and how far first amendment rights should stretch in a school setting. the constitution has served as a buoy for free expression and the free sharing of ideas, especially in our nation’s schools.56 the inability for students, teachers, and librarians to discuss lgbtq content in or around the classroom violates the first amendment and does not hold up against established first amendment 52. neb. press ass’n. v. stuart, 427 u.s. 539, 559 (1976). 53. shelton v. tucker, 364 u.s. 479, 487 (1960). 54. h.b. 1557, 2022 leg., 124th reg. sess. (fla. 2022) (enacted). 55. millhiser, supra note 48. 56. shelton, 364 u.s. at 487. 2024] keep saying gay 183 jurisprudence. before addressing the bulk of first amendment jurisprudence, it is important to note that the first amendment has been treated differently in schools than in other venues. additionally, there are two conflicting interests regarding the first amendment in schools: the need for open and free expression in schools and necessary bounds of that free expression.57 states can and do restrict speech for both teachers and students alike.58 the united states supreme court has recognized the “special characteristics of the school environment” and has given school districts limited ability to regulate student and teacher speech, with different standards applying to each subgroup.59 however, students are afforded certain rights to expression under the first amendment.60 it is important to concede that florida and other states’ “don’t say gay” bills do not expressly limit student discussion of lgbtq issues. however, student expression is implicated under the first amendment by the chilling effect “don’t say gay” bills have on student speech. in other words, even if the statute does not expressly limit student speech on lgbtq issues, it impliedly restrains students in classroom settings from speaking about those issues and incentivizes teachers to shut down conversations about lgbtq issues or risk liability for the school, the district, or themselves. 1. student expression a student’s right to expression is not “automatically coextensive with the rights of adults in other settings,” and therefore some speech afforded to adults may not be protected for students in public schools.61 students do not shed their constitutional rights upon entering a public school, and the supreme court recognized a standard for addressing when a school can constitutionally limit student speech.62 a school can limit speech if the speech constitutes, or the school can reasonably forecast, a “material and substantial interference” with school discipline and operation.63 additionally, schools and school districts can limit speech if it is lewd, vulgar, or plainly offensive.64 finally, a school or school district can restrict or censor speech that looks like school-sponsored speech, like a newspaper, if related to a legitimate pedagogical concern.65 finally, a school or school district can restrict or censor speech that looks like school-sponsored 57. scott f. johnson & sarah e. redfield, education law: a problem-based approach, 527 (6th ed. 2019). 58. id. 59. id. 60. id. 61. bethel sch. dist. v. fraser, 478 u.s. 675, 682 (1986). 62. tinker v. des moines indep. cmty. sch. dist., 393 u.s. 503, 506 (1969). 63. id. 64. fraser, 478 u.s. at 683. 65. hazelwood sch. dist. v. kuhlmeier, 484 u.s. 260, 276 (1988). 184 indiana health law review [vol. 21:177 speech, like a newspaper, if related to a legitimate pedagogical concern.66 florida’s don’t say gay bill has already had a direct impact on protected student expression, even under the hazelwood standard. in osprey, florida, senior class president zander moricz was restricted from even mentioning the word “gay” in a may 2022 commencement speech.67 importantly, this restriction of speech occurred roughly a month before the bill signed by ron desantis even went into effect.68 and while this speech technically would not be captured by the “parental rights in education” bill, its impact and anticipated implementation in schools across florida chilled student expression in a severely dehumanizing way. moricz is an openly gay activist and student and was told by the principal that if zander mentioned his activism or the word “gay” in his speech, his microphone would be cut off.69 moricz was able to subvert the restriction by talking about his “curly hair” as a metaphor, stating, “so while having curly hair in florida is difficulty due to the humidity, i decided to be proud of who i was and started coming to school as my authentic self.”70 when it comes to gender expression, students in many school districts across florida are now facing a similar chilling effect. for example, in leon county, fl, the school board unanimously approved its “lgbtq inclusive school guide” for the 2022-2023 school year.71 the guide includes a provision that alerts all parents in a respective class if a child who is open about their gender identity, is in their child’s physical education class, or on an overnight field trip with them.72 in other words, the school will forcibly “other”73 a transgender, gender-fluid, or non-binary student to their peers and their peers’ families, compelling “speech” that the lgbtq student may not have wanted to speak. using the tinker, fraser, and hazelwood standards, florida’s don’t say gay bill and its impacts thus far violate the first amendment rights of students. under tinker, a school can censor student speech when the speech causes, or is likely to cause, a material disruption.74 while florida school officials may be able to show that some lgbtq speech is likely to cause disruptions, it is wholly unconvincing that simply 66. id. 67. valerie strauss, told not to say ‘gay’ in graduation speech, he made his point anyway, wash. post (oct. 8, 2022), https://www.washingtonpost.com/education/2022/05/24/hecouldnt-say-gay-graduation-speech/ [https://perma.cc/92mb-zncd]. 68. id. 69. id. 70. id. 71. matt lavietes, as florida's 'don't say gay' law takes effect, schools roll out lgbtq restrictions, nbc news (oct. 8, 2022), https://www.nbcnews.com/nbc-out/out-news/floridasdon’t-say-gay-law-takes-effect-schools-roll-lgbtq-restrictions-rcna36143 [https://perma.cc/9pq74lbf]. 72. id. 73. “other” in this context connotes ostracization from the norm or a deviation from heteronormative gender and sexuality standards. 74. tinker v. des moines indep. cmty. sch. dist., 393 u.s. 503, 506 (1969). 2024] keep saying gay 185 acknowledging the existence of lgbtq people in or around a school building or event could cause a material disruption as required under tinker. ironically, the statute itself caused a material disruption to the educational environment, with student walkouts occurring across the state.75 one student in particular was suspended after he handed out pride flags at a walkout, with school administrators attempting to confiscate any flags that were distributed to other students.76 tinker’s armbands were clear political speech: a critique of american involvement in the vietnam war.77 in the same way, “saying gay” connotes clear political speech by students and should be afforded the strongest of constitutional protections. under fraser, schools can censor speech that is lewd, vulgar, indecent, or plainly offensive.78 lewd, vulgar, and indecent expression has been found to be “speech that is something less than obscene” and typically connotes “sexual innuendo” or “profanity.”79 additionally, student speech cannot be restricted simply because it is “inconsistent with an educator's sensibilities.”80 for example, students attempted to distribute an independent student publication featuring cartoon stick-figures in different sexual positions.81 the cartoon was found to be lewd and obscene based on its sexual content, and therefore eligible for public school censorship under the first amendment.82 perhaps most fitting, a commencement speech containing an elaborate and pervasive sexual innuendo was found to be plainly offensive and was able to be censored by a school.83 one of florida officials’ main defenses of the don’t say gay bill is that it protects younger students from “sexual content.”84 this seems to put student speech captured by the don’t say gay bill, expressly or through a chilling effect, directly under fraser. however, simply saying the word gay or having a classroom discussion about sexual orientation cannot reasonably be considered lewd, vulgar, indecent, or plainly offensive. and while lgbtq lives and existence may be offensive to some, student expression about lgbtq issues does not connote pervasive sexual content. a student speaking about growing up gay in florida is not the same as a pervasive sexual innuendo, yet this bill treats them as such. florida and other states with similar bills are suggesting that the mere mention of anything non-heteronormative is sexual in nature, and that is a 75. meryl phair, florida students are staging walkouts and getting suspended for handing out pride flags in protest, salon (oct. 12, 2022), https://www.salon.com/2022/03/09/floridastudents-are-staging-walkouts-and-getting-suspended-for-handing-out-pride-flags-in/ [https://perma.cc/2kfw-xgty]. 76. id. 77. tinker, 393 u.s. at 506. 78. bethel sch. dist. v. fraser, 478 u.s. 675, 682 (1986). 79. guiles ex rel. v. marineau, 461 f.3d 320, 327 (2d cir. 2006). 80. doninger v. niehoff, 527 f.3d 41, 49 (2d cir. 2008). 81. ochshorn ex rel. v. ithaca city sch. dist., 645 f.3d 533, 536 (2d cir. 2011). 82. id. 83. fraser, 478 u.s. at 682. 84. millhiser, supra note 48. 186 indiana health law review [vol. 21:177 dangerous and harmful idea. under hazelwood, a school may censor speech if the speech looks like it is school-sponsored and is related to a pedagogical concern.85 this is largely linked to school publications like newspapers and yearbooks.86 in anticipation of the don’t say gay bill, a florida school halted distribution of yearbooks until photographs of a student demonstration against the bill were “covered up.”87 the delay came as school officials, likely operating under the hazelwood doctrine, wanted to avoid speculation that the school supported student walkouts.88 it was reported that the photos in question showed students holding rainbow flags and signs stating, “love is love.”89 while censorship under hazelwood is likely the most persuasive for the state of florida, it still calls into question how censorship of the lgbtq community is “legitimately related to a pedagogical concern.” using the example above, the state would likely claim that the pedagogical concern was the actual student walkout, not the content of the messages conveyed at the walkout. that in and of itself is likely enough under the hazelwood standard to censor the school publication. associating a school with “anything other than neutrality on matters of political controversy” is eligible for censorship under hazelwood.90 it is difficult to claim that this is not a matter of political controversy, and for that reason, student speech under school-sponsored publications is likely limited. supporters of the don’t say gay bill claim that the bill is only about classroom instruction and protecting the rights of parents.91 however, as illustrated by new florida school district policies92 and explicit censorship of the word gay from a commencement speech,93 it is abundantly clear that school districts are reaching beyond the traditional classroom setting and into the personal lives of lgbtq students. already, teachers across florida have been asked to take down stickers showing support for lgbtq students and to remove rainbow items from classroom decorations.94 the public health impacts of limiting or restricting student speech about lgbtq issues cannot be understated. according to the trevor project’s 2021 85. hazelwood sch. dist. v. kuhlmeier, 484 u.s. 260, 260 (1988). 86. id. 87. brooke migdon, florida school delays yearbook distribution over photos of ‘don’t say gay’ protests, (oct. 12, 2022), https://thehill.com/changing-america/respect/equality/3483803florida-school-delays-yearbook-distribution-over-photos-of-don’t-say-gay-protests/ [https://perma.cc/6n7p-3crj]. 88. id. 89. id. 90. hazelwood sch. dist., 484 u.s. at 260. 91. millhiser, supra note 48. 92. lavietes, supra note 71. 93. strauss, supra note 67. 94. sarah mervosh, back to school in desantis’s florida, as teachers look over their shoulders, n.y. times (oct. 8, 2022), https://www.nytimes.com/2022/08/27/us/desantis-schoolsdon’t-say-gay.html [https://perma.cc/sfv7-tfu7]. 2024] keep saying gay 187 national survey of lgbtq youth mental health, queer and trans youth are four times more likely to consider or attempt suicide when compared to their heterosexual counterparts.95 additionally, two-thirds of lgbtq youth said debates concerning state laws about the lgbtq community in 2021 have had a negative impact on their mental health.96 these trends continued into 2022 and will be elaborated on in the public health impacts section of this note.97 when it comes to students in florida and across the country, their expression and discussion of lgbtq content must not be stifled. yes, the school does have “special characteristics,”98 but those characteristics do not allow for the pervasive intrusion into student expression as outlined in florida’s don’t say gay bill. while there may be “legitimate pedagogical concern” for censoring “pervasive sexual innuendo,”99 the existence and acknowledgement of lgbtq people is no more sexual than the existence or acknowledgment of heterosexual people or relationships. students should be permitted to speak about their identities freely without fear of retribution or punishment. and while supporters of this bill will say that it only restricts speech to a level that is “age-appropriate,” this bill and others like it go far beyond maturity and into ideology. for ron desantis and his supporters, being queer will never be “age-appropriate.” we must reject this notion vigorously and protect the first amendment rights of our students. after all, “[t]he vigilant protection of constitutional freedoms is nowhere more vital than in the community of american schools.”100 2. teacher expression similar to students, public school teachers do not shed their constitutional right to free speech when they accept employment with a school.101 in pickering, the supreme court held that an illinois high school science teacher had a first amendment right to send a letter to the editor of the local newspaper and affirmed that teacher’s right to comment on issues of public concern.102 notably though, this speech occurred outside the classroom.103 however, teachers now face an additional limitation on speech, as public employees no longer retain first amendment protection for speech that occurs 95. issues impacting lgbtq youth: polling analysis, morning consult: the trevor project, (jan. 2022), https://www.thetrevorproject.org/wp-content/uploads/2022/01/ trevorproject_public1.pdf [https://perma.cc/t4as-gl9n]. 96. id. 97. 2022 national survey on lgbtq youth mental health, the trevor project, (last visited feb. 27, 2023), https://www.thetrevorproject.org/survey-2022/ [https://perma.cc/5px4waw3]. 98. johnson & redfield, supra note 57. 99. bethel sch. dist. v. fraser, 478 u.s. 675, 682 (1986). 100. shelton v. tucker, 364 u.s. 479, 487 (1960). 101. pickering v. bd. of educ., 391 u.s. 563, 565 (1968). 102. id. 103. id. at 566. 188 indiana health law review [vol. 21:177 in the course of their official job duties.104 however, the majority in garcetti stated that “there is some argument that expression related to academic scholarship or classroom instruction implicates additional constitutional interests that are not fully accounted for by this court’s customary employee-speech jurisprudence.”105 and even though the court refused to decide if garcetti would apply in an academic context,106 the court’s analysis and reasoning have been applied to public school teachers as public employees.107 when garcetti is applied to teacher speech, the teachers generally lose.108 teachers in florida are already seeing an impact on their ability to speak about lgbtq issues.109 one florida middle school art teacher claims she was fired after answering student questions about her sexuality.110 after telling students that she was pansexual, and therefore attracted to all genders, several students asked to create art about their own genders and sexual orientation.111 after school administrators asked her to take down the student artwork, the teacher was sent home and fired.112 garcetti is a difficult standard for any teacher to overcome, particularly when that speech occurs directly in a classroom. however, there is something incredibly unique about the type of speech occurring in the example above. most notably, the students were the ones leading the conversation, not the teacher.113 reportedly, the extent of the conversation was the teacher being open and honest about her sexuality, giving it a dictionary definition, and allowing the students to make artwork reflecting their own individual sexuality or gender.114 even under garcetti, teachers do not lose all their free speech rights.115 and while garcetti certainly maintains that a school can limit speech, it does not say that it can limit identity. garcetti does not serve to make every public-school teacher a robot with no personality, characteristics, or personal history. rather, it allows for schools to make choices about the kinds of speech teachers alike can use during instruction and in their capacity as a teacher.116 if a heterosexual teacher mentions his wife, should that speech be censored under garcetti? should 104. garcetti v. ceballos, 547 u.s. 410, 413 (2006). 105. id. at 425. 106. id. at 432. 107. nathaniel levy, garcetti’s impact on teachers, onlabor (june 3, 2019), https://onlabor. org/garcettis-impact-on-teachers/ [https://perma.cc/c4px-9v8v]. 108. id. 109. matt lavietes, florida teacher allegedly fired after discussing sexuality with students, nbc news (may 6, 2022), https://www.nbcnews.com/nbc-out/out-news/florida-teacher-allegedlyfired-discussing-sexuality-students-rcna27656 [https://perma.cc/vq9c-hdpw]. 110. id. 111. id. 112. id. 113. id. 114. id. 115. garcetti v. ceballos, 547 u.s. 410, 413 (2006). 116. levy, supra note 107. 2024] keep saying gay 189 the government be able to censor his speech about his wife because that inherently implicates his sexuality or identity? does this restriction on first amendment rights only apply to queer teachers in the context of “don’t say gay” bills being introduced and passed across the country? florida’s don’t say gay bill uses garcetti as a hammer and ignores precedent set in pickering. teachers in their official duties as public-school employees often field questions about their personal lives, like whether they have a pet, what television shows they’re watching, who their spouse is, if they have any kids, etc. often, part of a district’s expectation for teachers is to get to know their class, establish boundaries, and garner respect from students.117 a male teacher referring to his wife likely gets no censorship from school administrators, like the question posed above. in other words, a teacher telling students that they are in a heterosexual relationship is acceptable. however, that same latitude seems to no longer be afforded to lgbtq teachers or allies. the standard garcetti sets for public school employees is far too high and encompasses speech that should be protected. a teacher simply telling students their sexuality may very well be “acting in their official capacity,” but the difference in speech protection between heterosexual teachers and lgbtq teachers is a clear violation of lgbtq teacher rights. this note does not argue that garcetti should be overruled, as there are important speech considerations for someone acting in their official role. rather, it asserts that garcetti should not apply to inherent characteristics about a teacher as a person, like their sexuality and gender. pickering also allows teachers to speak on matters of public concern, but not in the classroom.118 given the nation’s grappling with don’t say gay bills and lgbtq issues in education generally, it would be inappropriate jurisprudentially to prevent teachers from displaying pride flags or posting about lgbtq issues on their personal social media accounts. this teacher expression should be afforded the highest first amendment protection. 3. book bans queer storylines, even ones that include no mention or description of sexual content, “were found in more than half of the top [twenty] banned books of 2020.”119 this comes as a wave of school districts across the country seek to remove “controversial” content from libraries and curriculums alike.120 within the first few weeks of the 2022 school year, some teachers in florida at all grade levels were told to review every single book on their classroom 117. johnson & redfield, supra note 57, at 527. 118. pickering v. bd. of educ., 391 u.s. 563, 563 (1968). 119. kaitlin reilly, authors of lgbtq books for youth speak out about being banned: 'feels like an attack against my personhood, because that is what it is', (apr. 12, 2022), https://www.yahoo.com/lifestyle/banned-books-ya-queer-authors-173156815.html [https://perma.cc/gf98-7bcc]. 120. id. 190 indiana health law review [vol. 21:177 shelves for mention of “inappropriate” lgbtq content.121 ironically, many of the most challenged books of 2020 rose in the charts in spite of schools and parents challenging a book’s content or getting it removed from a school library or classroom curriculum.122 the supreme court has held that schools cannot remove books from its libraries to suppress ideas.123 importantly, the supreme court stated that “the constitution protects the right to receive information and ideas.”124 school officials may not remove books from a school library based on “narrowly partisan or political” grounds.125 however, a school could remove books from a library for vulgarity or if it is not educationally suitable.126 this is what the state of florida is likely aiming at with the don’t say gay bill. to “protect children,” florida officials are arguing that lgbtq content in schools is not “educationally suitable.” when it comes to curriculum, schools likely have broader discretion to restrict books.127 a school can restrict books for curriculum if related to a legitimate pedagogical concern, including related to student maturity, because it may look like the school is endorsing the book.128 what florida and other states are doing with their copycat bills is essentially placing lgbtq content in a box. in fact, the statute expressly addresses that all lgbtq content above grade 3 must be “developmentally appropriate” but fails to define what developmentally appropriate means.129 by keeping the definition vague, florida pushes school districts too far in their restriction on curriculum and libraries. schools are more likely to err on the side of caution and remove a book from a library or curriculum due to its lgbtq content to avoid liability under the don’t say gay bill.130 this problem was made worse by governor ron desantis and the florida legislature when governor desantis signed h.b. 1467, which requires school districts to review every book in their libraries and curriculums for “ageappropriateness.”131 this bill pushes books “under review” to see if they are restricted under the don’t say gay bill and the recent “stop woke act,”132 aimed at restricting instruction on race relations or diversity.133 h.b. 1467 calls 121. mervosh, supra note 94. 122. reilly, supra note 119. 123. bd. of educ., island trees union free sch. dist. v. pico, 457 u.s. 853, 858 (1982). 124. id. at 867. 125. id. at 854. 126. id. at 920. 127. virgil v. sch. bd. of columbia cnty., 862 f.2d 1517, 1522 (11th cir. 1989). 128. id. at 1521. 129. h.b. 1557, 2022 leg., 124th reg. sess. (fla. 2022) (enacted). 130. kiara alfonseca, more than 1 million books subject to review based on state's new laws, abc news (feb.13, 2023), https://abcnews.go.com/us/thousands-books-including-blackhispanic-historical-titles-review/story?id=97082518 [https://perma.cc/4c47-9dgu]. 131. h.b. 1467, 2022 leg., 124th reg. sess. (fla. 2023) (enacted). 132. h.b. 7, 2022 leg., 124th reg. sess. (fla. 2023) (enacted). 133. alfonseca, supra note 130. 2024] keep saying gay 191 for certified media specialists to review all books contained in classroom libraries or media centers across the state.134 in duval county, florida alone, approximately 1.6 million titles must be reviewed by certified media specialists.135 under florida’s don’t say gay bill, any book that references lgbtq content could be subject to removal from classroom or media center libraries.136 notably, h.b. 1467 covers all educational settings,137and schools have been encouraged by the florida department of education to “err on the side of caution” in determining developmental appropriateness.138 some schools in florida, like manatee county schools, removed or covered all materials that have not been reviewed by media specialists.139 this problem is no longer unique to florida, as schools across the country are facing challenges to books written by or about lgbtq people.140 in fact, teachers and librarians who fail to follow the new guidelines set out by the florida department of education and h.b. 1467 may be subject to criminal prosecution in the form of a felony.141 under florida’s don’t say gay bill and copycat bills across the country, there is a concerted effort to place any content that covers, reaches, or is written by lgbtq authors as not “educationally suitable” under pico.142 however, the supreme court has made it clear that the removal of books from libraries cannot be done for the suppression of ideas.143 florida’s don’t say gay bill, and its enforcement arm related to books, h.b. 1467, represents a government seeking to do just that: suppress ideas in educational settings. proponents of these efforts in florida claim that there are alarming amounts of “the most disturbing, pornographic books in…high school[s].”144 one of the books banned by a florida school district under the don’t say gay bill was and tango makes three, an award-winning book about a real-life same-sex penguin couple raising a chick.145 the school board of lake county school district said the book was "administratively removed due to 134. h.b. 1467, 2022 leg., 124th reg. sess. (fla. 2023) (enacted). 135. alfonseca, supra note 130. 136. id. 137. 2022 fla. sess. l. serv. ch. 2022-22 (c.s.c.s.h.b. 1467) (west). 138. alfonseca, supra note 130. 139. id. 140. id. 141. fabiola cineas, ron desantis’s war on “woke” in florida schools, explained, vox (feb. 15, 2023), https://www.vox.com/policy-and-politics/23593369/ron-desantis-florida-schoolshigher-education-woke [https://perma.cc/zxd7-7jbk]. 142. alfonseca, supra note 130. 143. board of educ., island trees union free sch. dist. v. pico, 457 u.s. 853, 871 (1982). 144. press release, governor ron desantis, governor ron desantis signs bill that requires curriculum transparency (mar. 25, 2022). 145. donald padgett, florida school district bans book on gay penguin couple, advocate (jan. 10, 2023), https://www.advocate.com/news/2023/1/10/florida-school-district-bans-bookpenguin-couple-don’t-say-gay. [https://perma.cc/2bl2-g95e]. 192 indiana health law review [vol. 21:177 content regarding sexual orientation/gender identification prohibited in hb 1557," otherwise known as don’t say gay bill.146 the book does not include any sexual content or instruction on sexual activity.147 if and tango makes three does not contain sexual content, why is it being removed from classroom libraries and media centers? the short answer is simple: florida is seeking to suppress the idea that queer people exist. even though samesex couples are not uncommon among penguins,148 florida’s government sees their very existence as a threat. this book about real penguins is not sexual. it is not “pornographic.” it is not “developmentally inappropriate.” it is queer. and that is enough for florida to decide that it cannot remain on classroom bookshelves.149 students retain and deserve the right to receive ideas.150 florida’s attempt to restrict the ideas able to be received by students egregiously violates established precedent in pico and cannot stand. b. public health impacts while don’t say gay bills across the country seem squarely focused on policing speech in educational settings, it is important to realize how anti-lgbtq rhetoric and chilled speech have direct and meaningful impacts on public health across the country and individual health outcomes for queer people. these outcomes are not hypothetical, and data shows severe risk to lgbtq youth, especially in relation to suicide and mental health.151 florida’s don’t say gay bills comes among a nationwide wave of anti-lgbtq legislation in state legislatures, with more bills than ever being proposed by legislators in 2022.152 according to the armed conflict location & event data project (acled)153, nearly 200 anti-lgbtq incidents were reported in 2022, representing three times the amount recorded in 2021 and twelve times the amount recorded in 2020.154 146. id. 147. id. 148. id. 149. id. 150. board of educ., island trees union free sch. dist. v. pico, 457 u.s. 853, 853 (1982). 151. the trevor project, supra note 97. 152. kelsey butler & ella ceron, colorado club shooting follows rise in anti-lgbtq rhetoric, violence, bloomberg (nov. 21, 2022), https://www.bloomberg.com/news/articles/202211-21/colorado-club-shooting-follows-rise-in-anti-lgbtq-rhetoric-violence [https://perma.cc/9buhjxkb]. 153. acled only collects data on physical activity; non-physical threats, harassment, or intimidation incidents that do not escalate into physical violence, or occur outside of physical demonstrations or propaganda events, are not captured. “demonstrations” include peaceful and violent protests; “political violence” includes acts of sexual violence, non-sexual attacks, and mob violence; and “offline propaganda distribution” includes activities like flyering and banner drops. 154. sam jones & roudabeh kishi, update | fact sheet: anti-lgbt+ mobilization on the rise in the united states, acled (nov. 23, 2022), https://acleddata.com/2022/11/23/update-factsheet-anti-lgbt-mobilization-in-the-united-states/ [https://perma.cc/l2va-u3gg]. 2024] keep saying gay 193 this rise in anti-lgbtq sentiment and violence coincides with right-wing politicians, like ron desantis in florida, advancing legislation and using violent rhetoric specifically targeting the lgbtq community.155 the trevor project’s 2022 national survey on lgbtq youth mental health is one of the most diverse surveys of lgbtq youth ever conducted.156 it recorded and cataloged the experiences of nearly 34,000 lgbtq youth ages thirteen through twenty-four in the united states in 2022.157 one of the survey’s most disturbing findings was that rates of suicidal ideation and suicidal thoughts have trended upward among lgbtq youth over the past three years, with 45% of lgbtq youth seriously considering attempting suicide in 2022.158 it is impossible to ignore the correlation between the rising amount of proposed and passed anti-lgbtq legislation159 and the rising suicide rates among lgbtq youth.160 this note does not attempt to say don’t say gay bills across the country are the sole cause of rising suicide rates among lgbtq youth, but rather that legislation like florida’s don’t say gay bill represent a capricious and violent subset of the population determined to erase the existence of lgbtq people entirely. proponents of don’t say gay bills will continue to say that their purpose is solely about parental control and removing “pornographic” or obscene material from schools.161 in reality, don’t say gay bills make lgbtq youth feel less safe and accepted in their schools.162 lgbtq youth who found their school to be lgbtq-affirming reported lower rates of attempting suicide.163 in schools where lgbtq identity is accepted, embraced, and affirming, students reported better mental health outcomes related to suicide.164 this is damning for don’t say gay bills and other anti-lgbtq legislation related to education. a school should be a place where students go to learn, develop, and become better people. a school should be a place where robust discussion occurs and ideas are expressed freely.165 a school should not be a place where a significant portion of the population feels ostracized and outcast for simply existing. discriminatory laws and policies, like florida’s don’t day gay bill and others like it, can contribute to feelings of rejection, stigma, and isolation, increasing the risk of mental health issues and suicide attempts among lgbtq 155. butler, supra note 152. 156. the trevor project, supra note 97. 157. id. 158. id. 159. elting, supra note 17. 160. the trevor project, supra note 97. 161. press release, supra note 144. 162. the trevor project, supra note 97. 163. id. 164. id. 165. shelton v. tucker, 364 u.s. 479, 487 (1960). 194 indiana health law review [vol. 21:177 individuals.166 in fact, 73% of lgbtq youth reported experiencing symptoms of anxiety in 2022, including more than three-quarters of transgender and nonbinary youth and nearly two-thirds of cisgender youth.167 58% of lgbtq youth reported experiencing symptoms of depression in 2022.168 florida’s don’t say gay bill prompted mental health organizations like the american academy of child and adolescent psychiatry (aacap) to issue formal statements condemning the bill and decrying its potential impacts.169 dr. warren ng, aacap president, wrote in this statement that: [a]s child and adolescent psychiatrists, we are the physician experts and advocates for children’s mental health, and we will continue to support our lgbtq+ youth and condemn all harmful legislation and actions. having a safe learning environment that supports healthy development is not a privilege, but a right for all youth . . . [t]his law grossly undermines the basic tenets of education policy by denying students access to and support from some of the most important and influential adults in their lives.170 others, like michael parent, phd and associate professor in the department of educational psychology at the university of texas at austin, worry that antilgbtq legislation may “empower people to ‘discriminate against, harass, and bully’ lgbtqia+ youth.”171 medical providers across the country have shared concerns about the potential detrimental impacts of anti-lgbtq legislation, particularly regarding legislation targeting gender-affirming care.172 in 2021, researchers at the university of michigan school of public health surveyed 103 providers of gender-affirming care from all fifty states.173 almost every provider indicated that laws restricting or banning gender-affirming care would negatively affect the mental health of transgender youth, noting that they would see increases in suicidal ideation, depression, anxiety, and addiction among their patients.174 166. the trevor project, supra note 97. 167. id. 168. id. 169. florida’s “don’t say gay or trans” law stigmatizes lgbtq+ youth and families, am. acad. of child & adolescent psychiatry, (mar. 18, 2022), https://www.aacap.org/aacap/ zlatest_news/floridas_dont_say_gay_or_trans_law_stigmatizes_lgbtq_youth_families [https://perma.cc/q8np-ekmw]. 170. id. 171. karen pallarito, how anti-lgbtqia+ legislation harms youth mental health, health, (june 15, 2022), https://www.health.com/news/lgbtqia-laws-and-youth-mental-health [https://perma.cc/2fbe-bccf]. 172. landon d. hughes et. al, "these laws will be devastating": provider perspectives on legislation banning gender-affirming care for transgender adolescents. 69 j. adolescent health 976, 978 (2021). 173. id. 174. id. 2024] keep saying gay 195 anti-lgbtq sentiment has been especially virulent regarding genderaffirming care.175 loud right-wing politicians like representative lauren boebert of colorado, have frequently accused transgender people and drag queens of “grooming” children without evidence.176 even with no evidence to back up claims of grooming, anti-transgender rhetoric bled into state legislatures, with bills taking aim at gender-affirming care for youth, bathroom usage, and sports bans for transgender individuals.177 93% of transgender and nonbinary youth said that they have worried about transgender people being denied access to gender-affirming medical care due to state or local laws.178 91% said they were worried about being denied access to the bathroom due to state or local laws.179 83% said that they have worried about being denied the ability to play sports due to state or local laws.180 don’t say gay bills place lgbtq youth in a negative spotlight, exacerbating already existing social pressures.181 instead of providing representation and support, schools limited by anti-lgbtq legislation like don’t say gay bills actively harm health outcomes for lgbtq individuals.182 amit paley, ceo & executive director of the trevor project, said, “the fact that very simple things—like support from family and friends, seeing lgbtq representation in media, and having your gender expression and pronouns respected—can have such a positive impact on the mental health of an lgbtq young person is inspiring, and it should command more attention in conversations around suicide prevention and public debates around lgbtq inclusion.”183 for many lgbtq youth, the implementation and effects of don’t say gay bills and other anti-lgbtq legislation is quite literally life or death. 14% of lgtbq youth attempted suicide in 2022, including 20% of transgender and nonbinary youth.184 a shocking 50% of lgbtq youth ages thirteen through seventeen considered suicide in 2022.185 our children are in crisis. while scrolling through tiktok, turning on the local news, or tuning into government press conferences, our lgbtq youth are consistently being told they do not belong.186 our students are being told to stop 175. butler, supra note 152. 176. id. 177. casey parks, club q shooting follows years of bomb threats, drag protests, anti-trans bills, wash. post, (nov. 20, 2022), https://www.washingtonpost.com/dc-md-va/2022/11/20/clubq-shooting-lgbtq-harassment/ [https://perma.cc/2egc-mzqr]. 178. the trevor project, supra note 97. 179. id. 180. id. 181. id. 182. florida’s “don’t say gay or trans” law stigmatizes lgbtq+ youth and families, supra note 169. 183. the trevor project, supra note 97. 184. id. 185. id. 186. press release, supra note 144. 196 indiana health law review [vol. 21:177 speaking and restrict their identities in school.187 our teachers are being directed to out transgender students,188 remove books,189 and keep quiet about the existence of lgbtq people.190 our children deserve better. it is our duty to protect their right to free expression, their right to receive ideas, and most importantly, their right to live. c. recent developments in march of 2023, ron desantis indicated that he would expand the impact of the don’t say gay bill191 by extending it to grades k-12.192 notably, this expansion is being proposed by the florida board of education, meaning that it does not require legislative approval.193 the proposed rule states that schools “[s]hall not intentionally provide classroom instruction to students in grades 4 through 12 on sexual orientation or gender identity unless such instruction is either expressly required by state academic standards … or is part of a reproductive health course or health lesson for which a student's parent has the option to have his or her student not attend.”194 desantis and his supporters have defended the “don’t say gay” bill on grounds that sexual orientation and gender identity are not appropriate for young children in grades k-3.195 with this recent proposal, desantis and florida republicans are now suggesting that lgbtq content is never acceptable in florida classrooms and is never “age-appropriate.” d. how indiana should move forward: proposed statutes to enshrine lgbtq education into indiana law indiana should become a leader in the united states for lgbtq education. enshrining statutes to recognize lgbtq youth in schools will serve multiple purposes: to protect our lgbtq youth; to attract progressive and loving families to relocate; to attract the best lgbtq workers and employers; to establish indiana’s place as a leader in public education. passing these statutes will involve the amendment of several statutes, including ind. code 20-30-5-13196 (instruction on human sexuality or sexually transmitted diseases) and ind. code 20-30-5-17197 187. strauss, supra note 67. 188. h.b. 1608, 123rd gen. assemb., first reg. sess. (ind. 2023). 189. alfonseca, supra note 130. 190. h.b. 1557, 2022 leg., 124th reg. sess. (fla. 2022) (enacted). 191. id. 192. anthony izaguirre, desantis to expand ‘don’t say gay’ law to all grades, ap news (mar. 22, 2023), https://apnews.com/article/don’t-say-gay-desantis-florida-genderd3a9c91f4b5383a5bf6df6f7d8ff65b6 [https://perma.cc/cl82-578a]. 193. id. 194. proposed rule no. 6a-10.081, 49 fla. admin. reg. 52, (mar. 16, 2023). 195. press release, supra note 144. 196. ind. code § 20-30-5-13 (2021). 197. ind. code § 20-30-5-17 (2021). 2024] keep saying gay 197 (access to materials relating to instruction on human sexuality, personal analysis, evaluation, or survey of students; consent and procedure for participation). therefore, i propose the following statutes: 1) beginning with students entering grade nine in the 2023–2024 school year, each school corporation, charter school, and state accredited nonpublic school shall require each student of the school corporation, charter school, or state accredited nonpublic school to successfully complete in grade nine, ten, eleven, or twelve one (1) semester of a lgbtq education course. 2) school districts are required to provide library services including a collection involving various mediums and literacy to students and teachers. students shall not be prohibited from accessing texts with lgbtq content. iv. conclusion florida’s don’t say gay bill is patently unconstitutional, as it restricts protected speech from teachers and students, restricts students from receiving important ideas, and chills further speech about lgbtq issues. this unconstitutional restriction on speech will continue to have severe public health impacts until lgbtq education and acceptance is enshrined into each of our institutions, and that change begins with public schools. indiana should adopt mandatory lgbtq education as a response to florida’s don’t say gay bill, setting indiana apart from the rest of the country as a safe haven for queer students across the country. this note unfortunately comes at a pivotal moment for lgbtq people in the united states. as a nation, we can choose to let our students and queer people live authentically or we can choose to keep terrorizing our queer youth, putting their lives and health at risk. indiana health law review volume xviii 2021 number 1 notes daddy doctor: why the rights of intended parents are not adequately protected in indiana* rani amani** i. introduction in 2019, almost family, a television series, premiered.1 it follows the story of a woman whose father, a fertility doctor, secretly inseminated several of his patients with his own sperm.2 rather than focusing on the obvious ethical dilemma, the show seems to make light of the situation as just another obstacle that was caused by foolish but good intentions.3 unlike almost family’s depiction, fertility fraud is a serious violation. for thirty-five years, liz white (“white”) believed that her son’s biological father was an anonymous sperm donor.4 white and her husband resorted to sperm donation in order to become parents, and they thought that their sperm donor was an anonymous medical resident.5 however, white later learned “that the sperm had come not from [an anonymous donor] but from the fertility doctor who had inseminated her.”6 this fertility doctor was dr. donald cline (“cline”), who ran * this note was completed in february 2020. ** j.d. candidate, 2021, indiana university robert h. mckinney school of law; b.s., 2015, purdue university. 1. almost family, imdb.com, https://www.imdb.com/title/tt9165444/ [https://perma.cc/ 93td-uegy] (last visited feb. 1, 2020). 2. kelly lawler, fox’s ‘almost family’ is a drama disaster that makes light of a heinous crime, usa today (oct. 2, 2019), https://www.usatoday.com/story/entertainment/tv/2019/ 10/03/almost-family-review-fox-drama-unmitigated-disaster/3817928002/ [https://perma.cc/av8r6buj]. 3. justin l. mack, why fox’s ‘almost family’ angers some children of an infamous indiana fertility doctor, indy star (oct. 23, 2019), https://www.indystar.com/story/news/health/ 2019/10/23/real-almost-family-donald-cline-case-no-comedy/3995192002/ [https://perma.cc/js6ls7sp]. 4. shari rudavsky, ‘i was raped 15 times and didn’t even know it’: fertility fraud bill advances, indy star (jan. 23, 2019), https://www.indystar.com/story/news/2019/01/23/donaldcline-aftermath-fertility-fraud-bill-advances-indiana-senate/2656610002/ [https://perma.cc/3xkqfdys]. 5. see id. 6. id. 124 indiana health law review [vol. 18:123 an indianapolis-area fertility clinic during the 1970s and 1980s.7 he fathered more than fifty children.8 in 2017, cline “pleaded guilty to two felony obstruction of justice charges, acknowledging that he lied to state investigators when denying . . . accusations that he used his own sperm” to inseminate patients.9 consequently, he “was [solely] given a one-year suspended sentence.”10 marion county prosecutors did not file other charges against cline because they felt that they were limited in the charges that they could pursue.11 at the time, indiana did not have a law against fertility fraud.12 though, this changed in 2019, after cline’s former victims, including white, combined efforts to modify indiana law to protect other individuals from doctors similar to cline.13 fertility fraud manifests when an adult learns, through genetic testing, that he was not only donor-conceived but also doctor-conceived.14 hence, the donorconceived child’s sperm donor is actually his parents’ fertility doctor. cline, unfortunately, is not the only doctor to have committed fertility fraud in the united states.15 memorably, dr. cecil jacobson (“jacobson”) “defrauded certain women and their husbands by representing that the women would be inseminated 7. mihir zaveri, a fertility doctor used his sperm on unwitting women. their children want answers., n.y. times (aug. 30, 2018), https://www.nytimes.com/2018/08/30/us/fertilitydoctor-pregnant-women.html [https://perma.cc/4m4u-rk7v]. 8. sarah zhang, a decades-old doctor’s secret leads to new fertility-fraud law, atlantic (may 7, 2019), https://www.theatlantic.com/science/archive/2019/05/cline-fertilityfraud-law/588877/ [https://perma.cc/jqc7-ptbk]. 9. zaveri, supra note 7. 10. tom davies, no jail for fertility doctor who lied about using own sperm, associated press (dec. 14, 2017), https://www.apnews.com/128c7319ef774b3ab90b6c 99e0986c5d [https://perma.cc/5sz9-lux5]. 11. tom davies, indiana doctor’s offspring pushing state fertility fraud law, associated press (jan. 23, 2019), https://www.apnews.com/91f17c7b87fa4039b109bd871e656e62 [https://perma.cc/6p72-xzvv]. 12. davies, supra note 10. 13. rudavsky, supra note 4. 14. professor jody lynee madeira, address at the indiana university robert h. mckinney school of law faculty colloquia series (nov. 12, 2019) (notes on file with the author) [hereinafter faculty colloquia series]; see jody lynee madeira, fertility fraud: an update, am. soc’y reprod. med. (oct. 21, 2019), https://www.asrm.org/news-and-publications/news-andresearch/legally-speaking/fertility-fraud-an-update/ [https://perma.cc/p9lc-4ey3]; see also dov fox et al., fertility fraud, legal firsts, and medical ethics, 134 obstetrics & gynecology 918, 918 (2019) (defining fertility fraud as “a doctor’s failure to obtain his fertility patient’s consent before inseminating her using his own sperm”). 15. robert t. garrett, fertility fraud is real. the texas senate approved a bill to make it a crime, dall. morning news (apr. 11, 2019), https://www.dallasnews.com/news/politics/ 2019/04/11/fertility-fraud-is-real-the-texas-senate-approved-a-bill-to-make-it-a-crime/ [https://perma.cc/x62r-lpxb]. 2021] daddy doctor 125 with sperm from an anonymous donor.”16 instead, “jacobson inseminated the[] women with his own sperm.”17 likewise, drs. kim mcmorries, gerald mortimer, john coates, paul jones, and an anonymous sacramento doctor inseminated their patients with their own sperm, rather than sperm from anonymous donors.18 similar cases exist around the world,19 and technology such as direct-to-consumer (“dtc”) genetic testing and social media will certainly continue to shed light on this type of wrongdoing.20 the united states fertility industry is largely unregulated,21 and cline’s misconduct highlights a significant problem with it. the number of fertility fraud cases and incidents of sperm bank negligence is rising.22 as a result, such beg the question: should the united states fertility industry be better regulated to protect the rights of intended parents and even donor-conceived children?23 thus far, california, indiana, and texas have tried to tackle this issue by implementing fertility fraud laws,24 and colorado has proposed legislation to make fertility fraud a felony.25 while indiana’s fertility fraud law may be the first of its kind,26 it inadequately protects the rights of intended parents. this note makes the novel 16. united states v. jacobson, 785 f. supp. 563, 566 (e.d. va. 1992). 17. id. 18. madeira, supra note 14; garrett, supra note 15; brian maass, first lawsuit filed against fertility dr. paul jones accuses him of deception, cbs denv. (oct. 29, 2019), https://denver. cbslocal.com/2019/10/29/paul-jones-fertility-lawsuit-fertility-sperm/ [https://perma.cc/bkk8acdn]. 19. madeira, supra note 14; agence france-presse in the hague, dutch fertility doctor ‘secretly fathered at least 49 children,’ guardian (apr. 12, 2019), https://www.theguardian. com/world/2019/apr/12/dutch-fertility-doctor-secretly-fathered-at-least-49-children [https://perma.cc/dww2-ftxg]. 20. see garrett, supra note 15; fox et al., supra note 14. 21. wendy kramer, sperm donation needs federal regulation, time (apr. 25, 2016), https://time.com/4299641/sperm-donation-needs-federal-regulation/ [https://perma.cc/kt3g7ycf]; but cf. judith daar, federalizing embryo transfers: taming the wild west of reproductive medicine?, 23 colum. j. gender & l. 257 (2012) (arguing that regulation of art exists); cf. michael ollove, advocates and experts debate need for more regulation of fertility services, kaiser health news (mar. 19, 2015), https://khn.org/news/advocates-and-experts-debate-needfor-more-regulation-of-fertility-services/ [https://perma.cc/xg8f-q42l] (“[p]rofessional selfregulation is extensive.”). 22. see jacqueline mroz, their children were conceived with donated sperm. it was the wrong sperm., n.y. times (june 3, 2019), https://www.nytimes.com/2019/06/03/health/spermbanks-fertility-artificial-insemination.html [https://perma.cc/7stb-pxqq]. 23. see id. 24. madeira, supra note 14. 25. sam tabachnik, proposed bill would finally make it a felony for doctors to inseminate patients with their own sperm, denv. post (jan. 9, 2020), https://www.denverpost.com/2020/01/ 09/fertility-fraud-paul-jones-sperm-doctor-colorado/ [https://perma.cc/sq3m-kv9h]. 26. zhang, supra note 8. 126 indiana health law review [vol. 18:123 claim that indiana’s fertility fraud law, the senate enrolled act 174, does not adequately protect the rights of intended parents because its criminal penalty is too lax. additionally, this note uniquely argues that indiana should implement a version of the uniform parentage act (“upa”). although other articles address the rights of intended parents or fertility fraud,27 the effect of indiana’s new fertility fraud law on the rights of intended parents in the state has not yet been explored. a. map of review section ii of this note discusses the history of fertility fraud and gamete donation, thereby describing relevant cases and definitions. it also addresses the lack of regulation in the united states and indiana fertility industries as well as details indiana’s change in this area of the law. section iii of this note offers an analysis of indiana’s new fertility fraud law, arguing that it is insufficient in protecting intended parents from fertility fraud due to the law’s minor criminal penalty. moreover, it compares indiana’s law to other state fertility fraud laws and asserts that indiana’s law is inferior to them. lastly, section iv of this note asserts that indiana should adopt a version of the upa to safeguard intended parents from negligence. ii. an overview of gamete donation, fertility fraud, and the fertility industry in the united states and indiana to facilitate a better understanding of gamete donation and fertility fraud, this section provides background information for these practices. in detail, it describes the history of gamete donation, outlines necessary definitions and cases, and discusses relevant concerns. additionally, this section explains the lack of regulation in the united states and indiana fertility industries. this section finally specifies changes in indiana law pertaining to gamete donation and fertility fraud. a. a brief history of gamete donation in 1884, william pancoast (“pancoast”), a philadelphia physician, performed the first successful artificial insemination.28 a couple visited pancoast because they were unable to conceive, and pancoast determined that this was due to the husband’s low sperm count.29 after two months of unsuccessful treatment, 27. see generally jody lynee madeira, uncommon misconceptions: holding physicians accountable for insemination fraud, 37 law & ineq. 45 (2019) [hereinafter uncommon misconceptions]; see generally jody lynee madeira, understanding illicit insemination and fertility fraud, from patient experience to legal reform, 39.1 colum. j. gender & l. 110 (2020) [hereinafter understanding illicit insemination]. 28. elizabeth yuko, the first artificial insemination was an ethical nightmare, atlantic (jan. 8, 2016), https://www.theatlantic.com/health/archive/2016/01/first-artificial-insemination/ 423198/ [https://perma.cc/5eyy-cgwf]. 29. id. 2021] daddy doctor 127 pancoast took matters into his own hands.30 specifically, he anesthetized his patient and inseminated her with donated sperm in front of six medical students.31 the sperm was donated by one of the medical students, who was nominated as the most attractive of the six.32 pancoast did not disclose any of this information to the couple until a healthy baby boy was born nine months later.33 and, even then, pancoast only confessed to the husband;34 “the two men decided that [the wife] would be better off not knowing the truth.”35 with the commercialization of sperm banks, sperm donation gained popularity roughly 100 years after pancoast’s feat.36 the donors were mainly from universities,37 and they were “screened for genetic diseases” and “matched phenotypically to the recipient’s husband.”38 by 1977, artificial insemination with donor sperm produced about 3,567 children.39 this estimate at least octupled by 2010, “the most recent year for which good data is available.”40 that year, between “30,000 to 60,000 babies born in the united states were conceived through sperm donation.”41 b. necessary definitions and information this subsection states important gamete donation definitions and information that uniquely relate to intended parents. for example, it describes the gamete donation process and the individuals that may participate in it. additionally, this subsection explains fertility fraud and outlines potential motivations and significant concerns, such as consanguinity, behind the dishonest conduct. 1. what is gamete donation? out of 100 american couples, approximately twelve to thirteen of them have trouble conceiving.42 consequently, many couples resort to gamete donation 30. id. 31. id. 32. id. 33. id. 34. id. 35. id. 36. see wendy kramer, a brief history of donor conception, huffpost (dec. 6, 2017), h t tps:/ /www.huffpost .com/entry/a-brief-history-of-donor-conception_b_9814184 [https://perma.cc/l9bs-ymwr]. 37. id. 38. id. 39. id. 40. ashley fetters, the overlooked emotions of sperm donation, atlantic (july 9, 2018), h t tps:/ /www.theatlan tic.com/family/archive/2018/07/sperm-donations-emotionalconsequences/564587/ [https://perma.cc/9nk4-bha8]. 41. id. 42. female infertility, u.s. dep’t health & hum. serv., https://www.hhs.gov/opa/ 128 indiana health law review [vol. 18:123 when a partner is unable to provide his own sperm or her own eggs.43 in short, gamete donation is the use of another individual’s eggs or sperm “in order to help an intended parent[] have a child.”44 although gamete donation is a viable solution to infertility, it also raises ethical considerations.45 these considerations include anonymity, payment, recruitment and screening of donors, assessment and screening of recipients, safety, and the donor-conceived child.46 in general, gamete donation is a delicate topic because it tests the genetic filiation of the family unit, a vital component of society.47 2. what is an intended parent, a donor-conceived child, or a gamete donor? intended or recipient parents are the terms used for the individuals who will raise a donor-conceived child.48 gamete donation permits “one of the intended parents to keep [a] genetic link to the child.”49 relatedly, a donor-conceived person is an individual who was conceived through sperm or egg donation. furthermore, a gamete donor is an individual who donates his or her gametes, such as sperm or eggs, to help another person conceive.50 accordingly, a sperm donor is a man who gives his sperm to a sperm bank or fertility clinic “so that it can be used to help women get pregnant.”51 although payment fluctuates, “an active [sperm] donor who produces specimens twice a week might make $1,500 a month.”52 similarly, an egg donor is a fertile woman who donates an egg to an infertile woman to help her have a child.53 egg donation is part of assisted reproductive reproductive-health/fact-sheets/female-infertility/index.html [https://perma.cc/jxu2-2hzy] (last visited oct. 25, 2019). 43. gamete (eggs and sperm) and embryo donation, reproductivefacts.org, https://www.reproductivefacts.org/news-and-publicat ions/patient-fact-sheets-andbooklets/documents/fact-sheets-and-info-booklets/gamete-eggs-and-sperm-and-embryo-donation/ [https://perma.cc/hwk5-7pzq] (last updated 2014). 44. id. 45. see european soc’y of human reprod. & embryology task force on ethics & law, iii. gamete and embryo donation, 17 hum. reprod. 1407 (2002). 46. id. 47. id. 48. gamete (eggs and sperm) and embryo donation, supra note 43. 49. id. 50. id. 51. sperm donor, merriam-webster, https://www.merriam-webster.com/dictionary/ sperm%20donor [https://perma.cc/e3gw-6y2n] (last visited oct. 25, 2019). 52. tamar lewin, 10 things to know about being a sperm donor, n.y. times (nov. 3, 2016), https://www.nytimes.com/2016/11/08/health/sperm-donor-facts.html [https://perma.cc/ 5ne3-sj6x]. 53. amanda chatel, how does egg donation work? experts and egg donors share what 2021] daddy doctor 129 technology (“art”), such as in vitro fertilization (“ivf”).54 an egg donor generally earns $8,000 for her donation.55 though, the american society of reproductive medicine (“asrm”) suggests that compensation to egg donors exceeding $5,000 requires justification, and payments in excess of $10,000 are inappropriate.56 3. how does gamete donation work? gamete donation functions either by inserting donor sperm into a woman’s reproductive tract or by combining donor eggs with sperm and transferring the resulting embryos to a woman’s uterus.57 some people use donated gametes . . . because of medical issues, such as no or poor-quality eggs or sperm. [others] use donation so they do not risk passing down genetic disorders to their children. donation can [also] be used for social reasons such as same-sex couples or for single men and women.58 4. what is fertility fraud? as previously described, fertility fraud is established when a donor-conceived person discovers that his biological father is his parents’ fertility doctor and not the sperm donor that his parents selected or consented to.59 “in [a] typical fertility fraud fact pattern, an adult learns that he or she has different paternal genetic relations and/or unexpected half-genetic siblings.”60 subsequently, communications with these new relatives often suggest that something is awry, eventually revealing that the donor-conceived person is actually doctorconceived.61 some states may group the fertility fraud fact pattern with wrongful life they want you to know, bustle (aug. 5, 2019), https://www.bustle.com/p/how-does-eggdonation-work-experts-egg-donors-share-what-they-want-you-to-know-18232805 [https://perma.cc/5gee-xr2a]. 54. jayne leonard, how does the egg donation process work?, med. news today (mar. 22, 2019), https://www.medicalnewstoday.com/articles/314750.php [https://perma.cc/ls52-rwjp]; id. 55. chatel, supra note 53. 56. michelle j. bayefsky et al., compensation for egg donation: a zero-sum game, 105 fertility & sterility 1153, 1153 (2016) (discussing compensation to egg donors). 57. reproductive technologies: v. gamete donation, encyclopedia.com, https://www. encyclopedia.com/science/encyclopedias-almanacs-transcripts-and-maps/reproductivetechnologies-v-gamete-donation [https://perma.cc/eb2h-4fkh] (last visited oct. 25, 2019). 58. gamete (eggs and sperm) and embryo donation, supra note 43. 59. see madeira, supra note 14. 60. id. 61. see id. 130 indiana health law review [vol. 18:123 cases.62 however, a wrongful life case is “a malpractice claim brought by or on behalf of a child born with a birth defect alleging that he or she would never have been born if not for the negligent advice or treatment provided to the parents by a physician or health-care provider.”63 accordingly, fertility fraud cases are distinguishable from wrongful life cases because doctor-conceived persons are not arguing that they would have never been born.64 instead, these individuals take issue with the process of their conception, not the outcome.65 aside from what fertility fraud is, the question of why is also imperative to understanding the wrongful practice. why would a fertility doctor engage in this type of misconduct? although one may never truly know the response to this question,66 there are educated guesses and potential answers. for example, a physician may substitute his own sperm for that of a sperm donor because he deludingly believes that he is helping desperate couples.67 the physician may argue that the sperm donation that the patient selected and consented to failed to impregnate her.68 also, a doctor may commit fertility fraud due to mental health issues, such as narcissistic personality disorder, sexual perversion, or because he did not properly coordinate sperm donors.69 regardless of the twisted motivation, the practice is truly abhorrent. it shatters personal identity and has destroyed families.70 one final question surrounding fertility fraud is how it affects families or donor-conceived children. in addition to feeling violated,71 intended parents and doctor-conceived persons are concerned about inheritable mental or genetic conditions.72 eve wiley, daughter of dr. kim mcmorries, turned to dtc genetic testing to learn more about her family’s medical history after her child was born with significant health problems.73 an additional concern is consanguinity, 62. faculty colloquia series, supra note 14. 63. wrongful life, merriam-webster, https://www.merriam-webster.com/legal/wrongful% 20life [https://perma.cc/fj8m-fbqs] (last visited feb. 1, 2020). 64. faculty colloquia series, supra note 14. 65. id. 66. see understanding illicit insemination, supra note 27, at 138. 67. see fox et al., supra note 14. 68. see paige skinner, biological dad was her mother’s fertility doctor, dall. observer (may 6, 2019), https://www.dallasobserver.com/arts/watch-eve-wiley-found-out-her-biologicaldad-was-her-mothers-doctor-11658200 [https://perma.cc/e37k-l4p8]. 69. faculty colloquia series, supra note 14. 70. understanding illicit insemination, supra note 27, at 113; see fox et al., supra note 14. 71. see faculty colloquia series, supra note 14; rudavsky, supra note 4. 72. faculty colloquia series, supra note 14. 73. chantalle edmunds, woman, 31, discovers her biological father is her mother’s fertility doctor when she uses an ancestry website and after 14 years of mistakenly calling a sperm donor ‘dad,’ daily mail (apr. 30, 2019), https://www.dailymail.co.uk/news/article6978769/woman-discovers-biological-father-mothers-fertility-doctor.html [https://perma.cc/3j8vspau]. 2021] daddy doctor 131 especially in close-knit communities like the area that cline practiced in.74 c. the lack of regulation in the united states fertility industry this subsection deconstructs the unregulated united states fertility industry. first, it briefly and generally describes the industry. second, it outlines current industry regulations and procedures, if any. last, it discusses problems associated with the industry as well as relevant cases that highlight these problems. 1. what is the united states fertility industry? the fertility industry is booming.75 today, there are over 100 sperm banks and approximately 480 fertility clinics in the united states.76 “investors are pouring money into companies that promise to help people conceive,” especially since one in seven women will experience fertility issues.77 though, investors are not only spending on treating infertility but also on preserving fertility.78 these investment areas represent two sizeable and growing areas of the fertility business. currently, the united states fertility business earns about $25 billion.79 by 2026, this estimate is projected to rise to $41 billion.80 this nearly twofold increase is unsurprising given the growing demand for art and ivf.81 additionally, the industry continues to draw venture capitalists,82 who spent $624 million on fertility firms in 2018.83 while the fertility industry is expanding in the united states, the business is also expanding in other nations around the world.84 what distinguishes the united 74. faculty colloquia series, supra note 14; bonnie steinbock, what’s wrong with a fertility doctor using his own sperm?, hastings ctr. (apr. 19, 2019), https://www.thehastingscenter. org/whats-wrong-with-a-fertility-doctor-using-his-own-sperm/ [https://perma.cc/te7l-cdym]. 75. the fertility business is booming, economist (aug. 8, 2019), https://www.economist. com/business/2019/08/08/the-fertility-business-is-booming [https://perma.cc/aw9h-34gf]. 76. fertility clinics & infertility services: $5.8 billion united states industry analysis, 2018 – researchandmarkets.com, ap news (nov. 30, 2018), https://apnews.com/businesswire/ de2625f77685482bb56020b3c4cc8d7d [https://perma.cc/lp7h-6bmr]. 77. the fertility business is booming, supra note 75; alexis christoforous, the fertility industry is booming, yahoo! (nov. 17, 2019), https://finance.yahoo.com/news/the-boomingbusiness-of-infertility-165325772.html [https://perma.cc/v8fb-hqyp]. 78. the fertility business is booming, supra note 75. 79. id. 80. id. 81. fertility clinics & infertility services: $5.8 billion united states industry analysis, 2018 – researchandmarkets.com, supra note 76. 82. christoforous, supra note 77. 83. the fertility business is booming, supra note 75. 84. id. 132 indiana health law review [vol. 18:123 states industry from the rest of the world is that it is not tightly regulated.85 this also applies to art, which includes gamete donation.86 2. how is the united states fertility industry barely regulated? in 1981, the first child conceived through art in the united states was born.87 consequently, the practice and use of art grew during the 1980s. almost forty years have passed since then, and still “no comprehensive policy governs art in” this country.88 instead, there is a “patchwork of . . . state and federal regulation that essentially leave the [united states] fertility industry unregulated.”89 even though the american fertility business is hardly supervised,90 congress attempted to take one step toward regulating art with the fertility clinic success rate and certification act of 1992 (“fcsrca”).91 congress adopted this act to address concerns about the quality and comparability of the information that infertility patients received about art.92 specifically, the fcsrca directs all fertility clinics to report their success rates to the centers for disease control and prevention (“cdc”) in a standardized manner.93 however, the cdc does not have the authority to enforce art clinics to do so.94 as a result, there are no legal consequences for clinics that do not report their success rates.95 relatedly, “neither the fertility industry nor any other entity is required to collect data or report statistics on the numbers of human beings conceived using 85. fertility clinics & infertility services: $5.8 billion united states industry analysis, 2018 – researchandmarkets.com, supra note 76; see also naomi cahn, when fertility clinics get it wrong, forbes (aug. 8, 2019), https://www.forbes.com/sites/naomicahn/2019/08/08/whenfertility-clinics-get-it-wrong/#576971431f4a [https://perma.cc/9c57-l7ku] (“the political economy of assisted reproduction in the united states wards off meaningful oversight or enforceable rules that operate to deter misconduct in other countries.”). 86. maya sabatello, regulating gamete donation in the u.s.: ethical, legal and social implications, 4 laws 352, 353 (2015). 87. the fertility clinic success rate and certification act, ctr. for disease control & prevention, https://www.cdc.gov/art/nass/policy.html [https://perma.cc/fc8t-pqcq] (last visited oct. 25, 2019). 88. alicia ouellette et al., lessons across the pond: assisted reproductive technology in the united kingdom and the united states, 31 am. j.l. & med. 419, 422 (2005). 89. id. at 435. 90. but cf. daar, supra note 21; cf. ollove, supra note 21. 91. the fertility clinic success rate and certification act, supra note 87. 92. id. 93. id.; national art surveillance, ctr. for disease control & prevention, https://www.cdc.gov/art/nass/index.html [https://perma.cc/c868-arl4] (last updated may 7, 2019); see also 42 u.s.c. § 263a-1 (2019). 94. see sonia suter, giving in to baby markets: regulation without prohibition, 16 mich. j. gender & l. 217, 252 (2009). 95. ouellette et al., supra note 88, at 419. 2021] daddy doctor 133 donor sperm.”96 therefore, even though fertility clinics are mandated to report success rate data to the cdc, this information is not narrowly shaped to identify the children successfully conceived using gamete donation. as a result, the united states has no reliable method of estimating how many donor-conceived children are born annually.97 however, experts believe that 30,000 to 60,000 american children born each year are conceived through sperm donation.98 nevertheless, this “number is only an educated guess.”99 apart from the fcsrca, the united states fertility business is also regulated by the united states food and drug administration (“fda”). particularly, the fda requires all art programs to register with the federal government.100 the agency also inspects these programs, including their documentation and written protocols.101 additionally, the fda regulates gametes, meaning sperm or eggs, as human reproductive tissue.102 however, similar to the cdc’s limited enforcement capabilities under the fcsrca, the fda’s authority is narrow as well.103 in particular, the fda “is limited to preventing the transmission of communicable diseases such as aids and hepatitis.”104 while the cdc and fda oversee aspects of the fertility industry, the business is still left largely unregulated. for example, federal law does not require infertility programs to be licensed or accredited.105 plus, there is no federal law that tackles the misappropriation of donor gametes. for this reason, various states are beginning to take matters into their own hands.106 the closest resource the united states has to any type of true regulation or oversight of art is the asrm’s guidelines. these guidelines address certain 96. wendy kramer, 30-60k us sperm and egg donor births per year?, huffpost (dec. 6, 2017), https://www.huffpost.com/entry/a-call-to-to-stop-using-t_b_8126736 [https://perma. cc/9y54-k9ay]. 97. id. 98. ashley fetters, finding the lost generation of sperm donors, atlantic (may 18, 2018), https://www.theatlantic.com/family/archive/2018/05/sperm-donation-anonymous/560588/ [https://perma.cc/nz3c-5hup]. 99. karen clark & elizabeth marquardt, the sperm-donor kids are not really all right, slate (june 14, 2010), https://slate.com/human-interest/2010/06/new-study-shows-sperm-donorkids-suffer.html [https://perma.cc/v2n5-mav2]. 100. practice comm., am. soc’y for reprod. med. & practice comm., soc’y for assisted reprod. tech., recommendations for gamete and embryo donation: a committee opinion, 99 fertility & sterility 47, 47 (2013). 101. id. at 47-48. 102. what you should know – reproductive tissue donation, u.s. food & drug admin., https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/what-you-should-knowreproductive-tissue-donation [https://perma.cc/89q8-krgj] (last updated nov. 5, 2010). 103. mroz, supra note 22. 104. id.; see also 21 c.f.r. § 1271.75 (2019). 105. ouellette et al., supra note 88, at 420. 106. see tabachnik, supra note 25. 134 indiana health law review [vol. 18:123 issues connected to fertility services.107 for instance, the guidelines for gamete donation discuss the selection, screening, and management of donors.108 the asrm also provides guidelines for record keeping.109 exclusively, it recommends that donor records be kept permanently, rather than for ten years as required by the fda.110 along with the asrm, the american association of tissue banks and the american fertility society attempt to remedy issues of insufficient federal regulation as well.111 3. how does the unregulated united states fertility industry negatively impact intended parents? in 2017, a couple (the “zelts”) sued xytex corporation (“xytex”), a sperm bank, for “allegedly misrepresenting a sperm donor’s mental health, educational level, and iq to induce . . . couple[s] to purchase his sperm for artificial insemination.”112 precisely, xytex described the sperm donor “as a genius-level neuroscientist with bachelor’s and master’s degrees who was pursuing a ph.d. in neuroscience engineering.”113 instead, the sperm donor was a “schizophrenic felon” who had extensive psychiatric and criminal histories.114 technology and the internet have certainly increased our access to information. the zelts learned that xytex made misrepresentations about their sperm donor after conducting an internet search on the donor and combing through public records.115 moreover, dtc genetic testing is gaining popularity and beginning to reveal sperm bank negligence or cases of fertility fraud. specifically, a rising number of intended parents are just discovering, years after the fact, that they received the wrong sperm donation.116 sperm banks are loosely regulated.117 therefore, sperm bank negligence, or donor mix-ups, are not surprising given the number of sperm banks that use 107. see suter, supra note 94, at 252-53. 108. practice comm., am. soc’y for reprod. med. & practice comm., soc’y for assisted reprod. tech., supra note 100, at 48-53. 109. id. at 53. 110. id. 111. tatiana posada, whose sperm is it anyways in the wild, wild west of the fertility industry?, 34 ga. st. u. l. rev. 847, 866 (2018). 112. mary anne pazanowski, couple can’t sue xytex, sperm bank that misrepresented donor, bloomberg l. (feb. 4, 2019), https://news.bloomberglaw.com/health-law-and-business/ couple-cant-sue-xytex-sperm-bank-that-misrepresented-donor [https://perma.cc/e9ar-jmj7]. 113. tamar lewin, sperm banks accused of losing samples and lying about donors, n.y. times (july 21, 2016), https://www.nytimes.com/2016/07/22/us/sperm-banks-accused-of-losingsamples-and-lying-about-donors.html [https://perma.cc/4nrt-pp46]. 114. id. 115. zelt v. xytex corp., no. 1:17-cv-4851-twt, 2018 wl 1014627, at 1 (n.d. ga. 2018). 116. mroz, supra note 22. 117. id. 2021] daddy doctor 135 outdated methods of labeling specimens, such as pen and paper.118 for instance, an african-american donor’s specimen was mistakenly substituted for that of a precisely-selected caucasian donor’s.119 the switch, unfortunately, occurred because “[s]perm vial numbers at the bank were written in pen and ink, and the facility’s records were not computerized.”120 “there are few legal remedies for parents who receive the wrong sperm . . . .”121 courts have upheld that there is no injury if the donor-conceived child is healthy because whether one donor is better than another is essentially unknown.122 also, in the zelts’ case, the eleventh circuit left the couple with little recourse by finding that the applicable state law did not recognize the birth of a child with undesirable inherited characteristics as a compensable legal injury.123 the number of donor-conceived children that are inheriting genetic diseases, learn that their donor was untruthful about his health history, discover that the sperm bank failed to inform them of reported illness, or uncover that they were doctor-conceived is growing.124 also, intended parents are accusing sperm banks of careless recordkeeping, using misleading descriptions to market sperm, or misappropriating sperm donated or banked for personal use.125 these discoveries and accusations represent significant problems with the united states fertility industry’s shortage of regulation. d. the lack of regulation in the indiana fertility industry and indiana’s change in this area of the law this subsection reviews the indiana fertility business. first, it explains relevant regulations and laws in indiana. second, it briefly summarizes indiana’s failed gamete donation act. last, it describes a change in this area of indiana law, such being the senate enrolled act 174. this act is also commonly referred to as indiana’s fertility fraud law. 1. how is the indiana fertility industry regulated? “there are two basic levels in the [united states] legal system: federal law and state law.”126 federal laws and regulations apply to all 50 states, while state laws 118. id. 119. cramblett v. midwest sperm bank, llc, 230 f. supp. 3d 865, 867 (n.d. ill. 2017). 120. mroz, supra note 22. 121. id. 122. harnicher v. univ. of utah med. ctr., 962 p.2d 67, 72 (utah 1998) (“[i]t is impossible to know whether the children of [the correct donor] would have been superior in any way to the [healthy] triplets . . . .”). 123. zelt v. xytex corp., 766 f. app’x 735, 739, 741 (11th cir. 2019). 124. kramer, supra note 21. 125. lewin, supra note 113. 126. lesley daunt, state vs. federal law: who really holds the trump card?, huffpost (mar. 20, 2014), https://www.huffpost.com/entry/state-vs-federal-law-who-_b_4676579 [https:// 136 indiana health law review [vol. 18:123 and regulations only apply to the specific state in which they were enacted.127 hence, in terms of art, indiana is subject to the fcsrca, fda, and its own laws or regulations. like the united states fertility industry, “[t]he regulation of private fertility clinics and gamete banks by individual states is also often lacking.”128 still, compared to the federal government, indiana seems to have taken steps toward better regulating its particular fertility business. for instance, indiana obligates physicians to collect the following information from sperm donors: name, address, date of birth, and social security number.129 in line with the fda’s regulations, indiana tests sperm donations for communicable and sexually transmitted diseases.130 however, a physician may order more tests for a donor “to rule out the presence of [other] infectious disease[s].”131 if a required medical or laboratory test indicates the presence of certain communicable or dangerous illnesses, physicians must report the donor to the state department and “attempt to notify [the] donor or recipient.”132 these diseases include syphilis, hepatitis, and hiv.133 similarly, hospitals, birthing centers, and abortion clinics must relate cases of artificial insemination with the incorrect gamete to the state department because they are reportable events.134 further, physicians may only use sperm donations if particular conditions are met.135 first, the gamete donation must be “frozen and quarantined for at least [180] days.”136 second, the donor must be retested for hiv after 180 days.137 indiana penalizes health care providers that do not comply with the required regulations.138 2. indiana’s failed gamete donation act in 2019, indiana attempted to better regulate gamete donation with house bill 1369.139 a portion of the bill, which exclusively addressed sperm and egg donation, was referred to as the indiana gamete donation act.140 the act perma.cc/vr34-pyjw]. 127. id. 128. sabatello, supra note 86; see also dov fox, reproductive negligence, 117 colum. l. rev. 149, 162 (2017). 129. ind. code § 16-41-14-12 (2019). 130. see ind. code § 16-41-14-6 (2019); see 410 ind. admin. code § 25-2-2 (2019). 131. 410 ind. admin. code § 25-2-4 (2019). 132. ind. code § 16-41-14-9 (2019); see generally ind. code § 16-41-2-1 (2019). 133. ind. code § 16-41-14-5 (2019). 134. 410 ind. admin. code §§ 15-1.4-2.2, 26-6-2, 27-6-2 (2019). 135. ind. code § 16-41-14-7 (2019). 136. id. 137. id. 138. ind. code §§ 16-41-2-8, -14-19 (2019). 139. h.b. 1369, 121st gen. assemb., 1st reg. sess. (ind. 2019). 140. id. 2021] daddy doctor 137 “amend[ed] provisions regarding testing of donated human sperm and eggs,” and set forth requirements for gamete donation agreements.141 it was a proposed new chapter for the indiana code.142 consistent with the asrm’s guidelines,143 the gamete donation act required gamete donors to undergo mental health and medical evaluations by specialists.144 likewise, it obligated intended parents to also complete a mental health evaluation.145 plus, the act required fertility clinics to comply with fda guidelines,146 thereby attempting to cure the fda’s inability to adequately regulate the fertility industry.147 nonetheless, the indiana gamete donation act was unfortunately not adopted.148 3. indiana’s change in this area of the law although the indiana legislature failed to adopt the gamete donation act, it passed the senate enrolled act 174 in 2019.149 governor holcomb signed the act into law after cline’s wrongdoing.150 the act “allows for civil action in response to fertility fraud and increases the penalty for fertility deception to a level 6 felony.”151 a level 6 felony is the “lowest [felony] level under indiana law.”152 regardless, the act is “the first such law in the country.”153 under the senate enrolled act 174, a woman who conceives after infertility treatment “may bring an action against a health care provider who knowingly or intentionally treated the woman for infertility by using the health care provider’s own [sperm] or [egg], without the [woman]’s informed written consent.”154 the woman’s surviving spouse or the resulting child may also initiate this action.155 141. id. 142. id. 143. practice comm., am. soc’y for reprod. med. & practice comm., soc’y for assisted reprod. tech., supra note 100, at 48-53. 144. h.b. 1369. 145. id. 146. see id. 147. mroz, supra note 22; see also 21 c.f.r. § 1271.75 (2019). 148. h.b. 1369. 149. kara kenney, governor signs fertility fraud and deception bill into law, rtv6 indianapolis (may 6, 2019), https://www.theindychannel.com/news/politics/governor-signsfertility-fraud-and-deception-bill-into-law [https://perma.cc/2ugv-hdzm]. 150. id. 151. casey smith, what you should know about these indiana laws going into effect july 1, indy star (july 1, 2019), https://www.indystar.com/story/news/politics/2019/07/01/newindiana-laws-july-1-2019-firearms-abortion-scooters-more/1459500001/ [https://perma.cc/l5q7fwng]. 152. madeira, supra note 14. 153. zhang, supra note 8. 154. ind. code § 34-24-5-2 (2019). 155. id. 138 indiana health law review [vol. 18:123 next, the act provides that a prevailing plaintiff is entitled to compensatory and punitive damages as well as liquidated damages of $10,000.156 compensatory, or actual, damages are of a sufficient amount to indemnify the harm, loss, or injury suffered.157 on the other hand, punitive damages are awarded in addition to compensatory damages when a defendant acted with recklessness, malice, or deceit.158 further, punitive damages penalize the wrongdoer. lastly, liquidated damages are a type of compensatory damages,159 and they set forth damages for breach of contract ahead of time.160 aside from civil causes of action for fertility fraud, the act creates a criminal cause of action.161 however, it originally advanced without a criminal penalty because a senate committee believed that there were protections already in place for intended parents under indiana law.162 nonetheless, the act was “amended to reinsert the criminal cause of action” because cline’s victims asserted that the criminal penalty was imperative in keeping doctors accountable.163 also, marion county prosecutors were limited in making a criminal case against cline under state law before the act was adopted.164 iii. indiana should implement a more stringent criminal penalty for fertility fraud this section analyzes the senate enrolled act 174, also commonly known as indiana’s fertility fraud law. first, it compares indiana’s law with other state fertility fraud laws, thereby illustrating how the act’s criminal penalty is too lax in protecting the rights of intended parents. second, it specifically discusses the interests of intended parents. last, it examines gaps in indiana law, analyzes the senate enrolled act 174’s effect on indiana intended parents, and asserts that indiana should implement a more stringent criminal penalty for fertility fraud. a. the senate enrolled act 174 compared to different state fertility fraud laws today, only three states have laws that exclusively tackle fertility fraud: 156. ind. code § 34-24-5-4 (2019). 157. actual damages, cornell l. sch., https://www.law.cornell.edu/wex/actual_damages [https://perma.cc/y2l9-wfrr] (last visited feb. 1, 2020). 158. punitive damages, cornell l. sch., https://www.law.cornell.edu/wex/punitive_ damages [https://perma.cc/be3e-72ks] (last visited feb. 1, 2020). 159. liquidated damages, cornell l. sch., https://www.law.cornell.edu/wex/liquidated_ damages [https://perma.cc/t2nk-xmv8] (last visited feb. 1, 2020). 160. id. 161. madeira, supra note 14. 162. kelly reinke, lawmakers remove criminal penalty from fertility fraud bill, fox 59 (jan. 23, 2019), https://fox59.com/2019/01/23/lawmakers-remove-criminal-penalty-from-fertilityfraud-bill/ [https://perma.cc/e5qw-dsye]. 163. madeira, supra note 14. 164. id. 2021] daddy doctor 139 california, indiana, and texas.165 however, colorado has proposed a bill to address the wrongful practice, “while florida and delaware are working on legislation this session.”166 this subsection outlines the fertility fraud laws in california and texas. also, it compares the senate enrolled act 174 to them. 1. california after more than ten years of trying to conceive, a california couple visited a fertility doctor at the university of california at irvine (“uci”).167 the doctor created twenty-one embryos, using the couples’ gametes, and froze all of them for future use.168 in 1995, the couple learned that three of their embryos were implanted in another woman without their consent.169 this woman gave birth to twins, the couple’s biological children.170 during the 1990s, “[s]tealing human tissue was not a crime.”171 health care providers at uci, in approximately thirty cases, allegedly took women’s eggs or patient embryos without their consent and gave them to other women.172 no less than fifteen births followed from this wrongful conduct, and uci whistleblowers reported this egg-theft scandal to officials.173 following the uci scandal, the california legislature adopted section 367g of the california penal code.174 such “criminalize[s] the fraudulent use or implantation of gametes or embryos in art for any purposes other than those chosen by the gamete or embryo provider[].”175 specifically, section 367g of the california penal code makes it unlawful for health care providers to knowingly use gametes or embryos for a different purpose than that specified by the gamete or embryo provider through written consent.176 it also makes it unlawful for health care providers to knowingly “implant these materials into someone who is not the person providing these materials without the provider’s signed written consent.”177 however, written consent is not mandatory for sperm donors that 165. tabachnik, supra note 25. 166. id. 167. cynthia sanz, a fertility nightmare, people (july 24, 1995), https://people.com/archive/ a-fertility-nightmare-vol-44-no-4/ [https://perma.cc/2sm4-d8e8]. 168. id. 169. id. 170. id. 171. register staff writer & teri sforza, should uc go after fertility fraud doctor’s assets?, orange county reg. (jan. 25, 2011), https://www.ocregister.com/2011/01/25/should-ucgo-after-fertility-fraud-doctors-assets/ [https://perma.cc/x46k-b9et]. 172. sanz, supra note 167. 173. register staff writer & sforza, supra note 171. 174. madeira, supra note 14. 175. uncommon misconceptions, supra note 27, at 49. 176. cal. penal code § 367g (2019). 177. uncommon misconceptions, supra note 27, at 65 (citations omitted); see also id. 140 indiana health law review [vol. 18:123 donate to a licensed sperm bank.178 an individual who violates section 367g of the california penal code is punished by imprisonment for three to five years, fined up to $50,000, or both.179 until 2019, the year that the senate enrolled act 174 was passed in indiana, california was the only state in the nation that expressly outlawed fertility fraud.180 though, these two pieces of legislation are dissimilar in a couple of ways. first, the indiana law distinctively addresses the use of a health care provider’s own gametes in art.181 thus, the senate enrolled act 174 seems more focused on the rights of intended parents,182 whereas section 367g of the california penal code focuses more so on the rights of gamete or embryo providers.183 second, the indiana law imposes a lesser criminal penalty, a level 6 felony, on violators of it. particularly, under indiana criminal law, an individual who commits a level 6 felony is “imprisoned for a fixed term of between six months . . . and two and one-half years.”184 also, the person may not be fined in excess of $10,000.185 this criminal penalty is much less than that imposed by section 367g of the california penal code.186 2. texas in 2003, eve wiley (“wiley”), a texas woman, learned that she was donorconceived.187 although confused at first, she was also excited to learn more about her biological father, donor #106.188 soon thereafter, she met donor #106.189 though, in a turn of events, wiley later discovered that her mother’s fertility doctor impregnated “her mother with his own sperm, making him – not donor #106 – her biological father.”190 after lobbying to change texas law, wiley successfully pushed the texas 178. penal § 367g. 179. id. 180. leila ettachfini, doctors can legally inseminate patients with their own sperm in most states, vice (apr. 22, 2019), https://www.vice.com/en_us/article/pajdn7/fertility-fraudinsemination-laws-donald-cline [https://perma.cc/m66t-4vpj]. 181. ind. code § 34-24-5-2 (2019). 182. see id. 183. see penal §367g. 184. ind. code § 35-50-2-7 (2019). 185. id. 186. see penal §367g. 187. kyra phillips et al., texas woman seeks to change law after dna test reveals shocking truth about her genetic family tree, abc news (may 3, 2019), https://abcnews.go. com /u s/ texas -wom an -seeks-change-law-dna-tes t -r evea ls / s to ry? id= 6 2 8 0 9 1 2 7 [https://perma.cc/9mf2-bru5]. 188. id. 189. id. 190. id. 2021] daddy doctor 141 legislature to pass a fertility fraud law.191 in 2019, texas passed senate bill no. 1259,192 which makes “fertility fraud a new category of sexual assault” in the state.193 the law expressly makes it a sexual assault for a health care provider, who is performing art on a patient, to “use[] human reproductive material from a donor knowing that the [patient] has not expressly consented to the use of material from that donor.”194 “physicians violating this provision can be sentenced to between six months and two years in prison and be fined up to $20,000.”195 additionally, a physician found guilty under the texas “law must register as a sexual offender.”196 while the texas and indiana fertility fraud laws are alike in that violators may be imprisoned for similar amounts of time,197 the senate bill no. 1259 is unique in that it classifies fertility fraud as a new category of sexual assault.198 hence, the texas law seems to better get at what fertility fraud really is.199 not only has a physician betrayed his patient’s trust but also the doctor-patient fiduciary relationship.200 further, the physician has literally inserted a “part of himself into the [patient]’s bodily cavity” without her consent, thereby violating her autonomy.201 b. fertility fraud and the interests of intended parents while intended parents have several different interests, there are three that are most relevant to this note: patient autonomy, being touched by a doctor with appropriate motives, and receiving properly screened gametes. this subsection describes each of these interests in order. 1. patient autonomy patient autonomy is “[t]he right of patients to make decisions about their 191. edmunds, supra note 73. 192. robert t. garrett, dallas woman’s push to make fertility fraud a crime results in new law on the books in texas, dall. morning news (june 5, 2019), https://www.dallasnews.com/ news/politics/2019/06/05/dallas-woman-s-push-to-make-fertility-fraud-a-crime-results-in-new-lawon-the-books-in-texas/ [https://perma.cc/yj2b-6y5h] [hereinafter dallas woman’s push]. 193. garrett, supra note 15. 194. s.b. 1259, 86th leg. (tex. 2019); dallas woman’s push, supra note 192. 195. madeira, supra note 14. 196. jeffrey martin, fertility doctors using their own sperm for fertilization leads to ‘fertility fraud’ legislation in 3 states, newsweek (nov. 5, 2019), https://www.newsweek. com/fertility-doctors-using-their-own-sperm-fertilization-leads-fertility-fraud-legislation-3-1469975 [https://perma.cc/j3hr-hu39]. 197. see s.b. 1259; see h.b. 1369, 121st gen. assemb., 1st reg. sess. (ind. 2019). 198. s.b. 1259. 199. ettachfini, supra note 180. 200. id. 201. id. 142 indiana health law review [vol. 18:123 medical care without their health care provider trying to influence the decision.”202 patient autonomy does not permit a physician to make a health care decision for the patient.203 though, the physician may educate the patient on his or her condition.204 according to the code for professional ethics for the american college of obstetricians and gynecologists, respect for patient autonomy is fundamental.205 in kaplan v. mamelak, a patient sued his surgeon for medical malpractice and battery, claiming that he suffered pain after the surgeon twice operated on the patient’s wrong herniated disks.206 the california court reasoned that “a battery occurs if [a] physician performs a ‘substantially different treatment’ from that covered by the patient’s expressed consent.”207 thus, a doctor who operates on a patient without the patient’s informed or express consent commits a battery. similarly, under indiana law, “[t]he failure to obtain informed consent rises to the level of battery only when [a] physician completely fails to obtain” it.208 an obstetrician-gynecologist, or fertility doctor, is obligated to obtain informed consent from each patient.209 informed consent transpires when communication between a doctor and patient “results in the patient’s authorization . . . to undergo a specific medical intervention.”210 consent to inseminate with a specific specimen “does not constitute consent to insemination with any type of sperm whatsoever.”211 doctors who impregnated their patients with their own sperm “never obtained consent to do so.”212 instead, these doctors agreed to inseminate the patient with a sperm donation or a husband’s sample.213 thus, intended parents in fertility fraud cases have a right to autonomy. 202. william c. shiel, medical definition of patient autonomy, medicinenet, https://www. medicinenet.com/script/main/art.asp?articlekey=13551 [https://perma.cc/6gf7-959v] (last visited feb. 1, 2020). 203. id. 204. id. 205. code of professional ethics of the american college of obstetricians and gynecologists, am. c. obstetricians & gynecologists, https://webcache.googleusercontent.com/search?q= cache:wscyvnq_au0j:https://m.acog.org/about-acog/acog-departments/committees-andcouncils/volunteer-agreement/code-of-professional-ethics-of-the-american-college-ofo bs t e t r ic ian s -and-gynecologists+&cd=1&hl=en&ct=clnk&gl=us&client=safari [https://perma.cc/88sw-atm5] (last visited mar. 26, 2020). 206. kaplan v. mamelak, 162 cal. app.4th 637, 637 (cal. ct. app. 2008). 207. id. at 646. 208. van sice v. sentany, 595 n.e.2d 264, 267 n.6 (ind. ct. app. 1992). 209. code of professional ethics of the american college of obstetricians and gynecologists, supra note 205. 210. informed consent, ama, https://www.ama-assn.org/delivering-care/ethics/informedconsent [https://perma.cc/e9jx-ly7u] (last visited feb. 1, 2020). 211. understanding illicit insemination, supra note 27, at 166 (emphasis added). 212. id. 213. id. 2021] daddy doctor 143 2. touching and appropriate motives within the last year, at least six gynecologists were accused of sexual assault.214 although the majority of physicians cannot fathom engaging in this type of behavior, “[i]t is no longer sufficient to rely solely on physicians’ professed good intentions to ensure that patients are adequately protected.”215 patients have a right to be treated for legitimate medical reasons as well as an interest in being touched for clinical reasons and within the course of professional duties.216 fertility doctors, or obstetrician-gynecologists, that engage in sexual misconduct abuse their professional power and violate patient trust.217 relatedly, “[a] physician who obtains sexual gratification from inseminating a patient with an appropriately anonymous donor sperm sample is engaging in an illicit touching.”218 the physician, simply, is using his patient for an inappropriate purpose.219 moreover, “[w]hen a physician procures his own sperm sample though masturbation and moments later uses that sample to inseminate[] his female patient, the violation is compounded: the patient is not only being penetrated for an unconsented-to purpose” but also “unwittingly help[s] the physician sow his seed as widely as possible.”220 3. properly screened gametes as previously discussed, the fda “requires basic screening for infectious diseases and [specific] risk factors before a man can become a sperm donor.”221 additionally, certain states may require further screening.222 today, the fda particularly requires sperm donors to be tested for communicable diseases.223 214. christina caron, identifying red flags at the ob-gyn, n.y. times (jan. 22, 2020), https://parenting.nytimes.com/pregnancy/ob-gyn-sexual-assault?smtyp=cur&smid=tw-nytimes [https://perma.cc/86he-3876]. 215. id. 216. see amy blair & katherine wasson, professionalism and appropriate expression of empathy when breaking bad news, 17 ama j. ethics 111, 113 (2015). 217. code of professional ethics of the american college of obstetricians and gynecologists, supra note 205. 218. understanding illicit insemination, supra note 27, at 177; see also comm. on ethics, sexual misconduct, am. c. obstetricians & gynecologists (jan. 2020), https://www.acog. org/clinical/clinical-guidance/committee-opinion/articles/2020/01/sexual-misconduct [https://perma.cc/em2l-z4xz] (“the patient-physician relationship is damaged when there is either confusion regarding professional roles and behavior or clear lack of integrity that allows sexual exploitation and harm.”). 219. see understanding illicit insemination, supra note 27, at 177. 220. id. 221. sperm donation, mayo clinic, https://www.mayoclinic.org/tests-procedures/spermdonation/about/pac-20395032 [https://perma.cc/29r8-juu2] (last visited feb. 1, 2020). 222. id. 223. what you should know – reproductive tissue donation, supra note 102. 144 indiana health law review [vol. 18:123 these diseases include hiv, hepatitis, and other sexually transmitted infections.224 sperm donors are not only tested for infectious or communicable diseases before providing their sample but also six months after the sample is received.225 to protect intended parents, the asrm also recommends that sperm donors undergo a physical exam, semen testing, genetic testing, and a psychological evaluation.226 in addition, a sperm donor should be between eighteen and thirtynine years old, and he should have his family medical history, personal history, and sexual history evaluated.227 although some of these regulations or recommendations were not yet in place when certain patients were illicitly inseminated, these patients still had an interest in verifying that their sperm donors were disease-free.228 moreover, these individuals “had interests in expecting that their physicians would use sperm donor samples that had been appropriately screened in at least [three additional] senses:” (1) to confirm the sample’s origin, (2) to confirm that the donor phenotypically matched the husband, and (3) to prevent consanguinity.229 c. the senate enrolled act 174’s effect on indiana intended parents this subsection specifically analyzes the impact of indiana’s fertility fraud law on intended parents and asserts that the indiana legislature should adopt a more stringent criminal penalty for fertility fraud. first, it outlines gaps in indiana criminal law. then, it describes how the senate enrolled act 174 potentially fills these gaps as well as the act’s advantages, disadvantages, and potential solutions. 1. relevant gaps in indiana criminal law fertility fraud cases often “fall within gaps in civil and criminal law.”230 for example, in indiana, the state’s rape statute does not correspond well with cline’s conduct.231 under indiana law, rape occurs when “a person knowingly or intentionally has sexual intercourse with another person or knowingly or intentionally causes another person to perform or submit to other sexual conduct.”232 additionally, the other person must either be (1) “compelled by force or imminent threat of force,” (2) “unaware that the sexual intercourse or other sexual conduct” is happening, or (3) mentally disabled or deficient to consent to 224. id. 225. sperm donation, supra note 221. 226. id. 227. id. 228. understanding illicit insemination, supra note 27, at 169. 229. id. 230. id. at 113. 231. uncommon misconceptions, supra note 27, at 57. 232. ind. code § 35-42-4-1 (2019). 2021] daddy doctor 145 sexual intercourse or sexual conduct.233 in terms of cline’s misconduct, only the second provision seems applicable because cline’s patients were unaware that they were being inseminated with his sperm.234 however, marion county prosecutors did not pursue cline under indiana’s rape statute because they “believed that it would be too difficult to prove that cline’s actions were sexually motivated without an admission from him saying so.”235 therefore, cline’s “acts are not traditionally prosecutable as rape or sexual assault” because his victims ‘“consented’ to the inseminations.”236 in addition, indiana’s sexual battery statute is also inconsistent with cline’s conduct. sexual battery in indiana is a level 6 felony for the context of this note.237 the statute states that an individual commits sexual battery if he or she touches another individual who is either (1) “compelled to submit to the touching by force or the imminent threat of force” or (2) unable to consent to the touching due to mental disability or deficiency.238 also, a person commits sexual battery if he or she “touches another person’s genitals, pubic area, buttocks, or female breast when that person is unaware that the touching is occurring.”239 for each of these provisions, the wrongdoer must engage in the touching with an “intent to arouse or satisfy [his or her] own sexual desires or the sexual desires of another person.”240 none of the aforementioned sexual battery provisions seem to apply to cline’s conduct. specifically, “cline did not use or threaten force against his patients, did not give them drugs of which they were unaware, and had consent to touch their genital areas.”241 moreover, indiana’s criminal battery and malicious mischief statutes “do not map well onto cline’s conduct” either.242 for instance, an individual commits criminal battery, a class b misdemeanor, if he “knowingly or intentionally: (1) touches another person in a rude, insolent, or angry manner; or (2) in a rude, insolent, or angry manner places any bodily fluid or waste on another person.”243 prosecution of cline under this statute would likely fail because “there is little to no evidence that cline conducted the inseminations in a rude, insolent, or angry manner.”244 also, prosecution may be problematic because cline’s patients consented to insemination with donor sperm.245 233. id. (emphasis added). 234. ettachfini, supra note 180. 235. id. 236. understanding illicit insemination, supra note 27, at 113. 237. see ind. code § 35-42-4-8 (2019). 238. id. 239. id. 240. id. 241. understanding illicit insemination, supra note 27, at 190. 242. uncommon misconceptions, supra note 27, at 57. 243. ind. code § 35-42-2-1 (2019). 244. uncommon misconceptions, supra note 27, at 57. 245. id. at 58. 146 indiana health law review [vol. 18:123 finally, indiana’s malicious mischief statute states that an individual commits a class b misdemeanor if he recklessly, knowingly, or intentionally places human bodily fluid or fecal waste “in a location with the intent that another person will involuntarily touch” it.246 moreover, if the person “recklessly failed to know that the bodily fluid . . . was infected with” hepatitis, hiv, or tuberculosis, then he may be convicted of either a level 6 felony, level 5 felony, or level 4 felony depending on the circumstances.247 with respect to cline’s case, the indiana legislature probably did not intend to “apply malicious mischief to the placement of bodily fluid in the context of a medical procedure.”248 also, reports do not indicate that cline’s victims were infected with any infectious or communicable diseases. 2. the senate enrolled act 174: advantages and disadvantages this subsubsection summarizes the senate enrolled act 174’s advantages and disadvantages. it initially describes how the act fills gaps in indiana criminal law, thereby better protecting the interests of intended parents. then, it explains the act’s deficiencies and asserts that the indiana legislature should adopt a more stringent criminal penalty for fertility fraud. a. advantages as previously mentioned, the senate enrolled act 174 is “the first such law in the country.”249 to reiterate, it allows a woman who conceives after infertility treatment to “bring an action against a health care provider who knowingly or intentionally treated the woman by using the health care provider’s own [sperm] or [egg], without the [woman]’s informed written consent.”250 the act fills gaps in indiana criminal law by better protecting patient autonomy, which is an interest of intended parents. in detail, the act enforces that consent to inseminate with one sperm sample does not constitute consent to inseminate with any sperm sample. thus, with respect to consent, the act remedies gaps left by indiana’s rape, sexual battery, and criminal battery statutes. additionally, the act’s criminal penalty is either greater than or equal to the penalties for sexual battery, criminal battery, or malicious mischief.251 for example, a person who commits criminal battery or malicious mischief may not be imprisoned for more than 180 days,252 which is significantly less than the act’s 246. ind. code § 35-45-16-2 (2019). 247. id. 248. uncommon misconceptions, supra note 27, at 57. 249. zhang, supra note 8. 250. ind. code § 34-24-5-2 (2019). 251. compare h.b. 1369, 121st gen. assemb., 1st reg. sess. (ind. 2019), with ind. code § 35-42-4-8 (2019), and ind. code § 35-42-2-1 (2019), and § 35-45-16-2. 252. see ind. code §§ 35-42-2-1, -45-16-2, -50-3-3 (2019) (showing that criminal battery and malicious mischief are both class b misdemeanors). 2021] daddy doctor 147 possible imprisonment term of six months to two and one-half years.253 thus, in comparison to the various indiana criminal statutes that cline could not be prosecuted under, the act imposes a serious criminal penalty and better protects the interests of intended parents by treating illicit insemination as a serious crime. b. disadvantages and potential solutions although the senate enrolled act 174 is a step in the right direction, there is still room for improvement. particularly, the act does not suitably protect intended parents from illicit touching by a physician or from receiving improperly screened gametes. first, the act is insufficient because it does not completely fill the gap left by indiana’s rape statute. to illustrate, there are two relevant types of touching for the purposes of this note: clinical and sexual. as previously described, a clinical touch occurs when a physician touches a patient for clinical reasons and within the course of professional duties.254 alternatively, a sexual act includes genital penetration with an object, along with an intent to “gratify the sexual desire of any person.”255 although cline or other fertility fraud perpetrators could argue that their illicit inseminations were clinical touches or acts, how are these inseminations “still clinical when the physician . . . masturbates . . . in a nearby room, catches his sample, walks to the [patient] examination room,” and then “inserts [the] sample into [the patient’s] vagina via a syringe and catheter?”256 further, how is illicit insemination not a sexual act when cline was likely under “orgasm’s physiological effects when he inseminated his patients”?257 the senate enrolled act 174 does not protect intended parents from illicit touching by a physician.258 to cure this, the indiana legislature, similar to the texas legislature, should classify illicit insemination as a sex crime because it involves a sexual act. liz white, one of cline’s victims, asserts that “the [fifteen] times . . . cline inseminated her . . . constituted nothing less than sexual assault.”259 moreover, classifying fertility fraud as a sex crime more accurately portrays what the wrongful practice is: a betrayal of the doctor-patient fiduciary relationship.260 relatedly, indiana physicians who are convicted of sex crimes may have their 253. see smith, supra 151; see ind. code §§ 35-43-5-3, -50-2-7 (2019). 254. blair & wasson, supra note 216. 255. what is a sexual act, sexual contact, or sexual activity?, rockland community c., https://www.sunyrockland.edu/about/title-ix/sexual-assault-violence-harassment-faq/what-is-asexual-act-sexual-contact-or-sexual-activity [https://perma.cc/wzk3-92tc] (last visited feb. 1, 2020). 256. uncommon misconceptions, supra note 27, at 58. 257. understanding illicit insemination, supra note 27, at 192. 258. see ind. code § 34-24-5-2 (2019). 259. rudavsky, supra note 4. 260. ettachfini, supra note 180. 148 indiana health law review [vol. 18:123 medical licenses either suspended, denied, or revoked.261 therefore, illicit insemination should also be categorized as a sex crime because this classification may better deter future perpetrators.262 further, this classification is superior because it may involve a more serious felony level and require perpetrators to register as sex offenders.263 this could additionally deter offenders by removing a perpetrator from society and putting those with similar objectives on notice.264 second, the senate enrolled act 174 is insufficient because it does not fill the gap left by indiana’s malicious mischief statute. for instance, the act does not better allow for the prosecution of individuals who illicitly inseminate their patients and recklessly infect them with an infectious or communicable disease.265 therefore, the act does not hold future fertility fraud perpetrators accountable for the improper screening of gametes, an important interest of intended parents. to better protect these individuals, the indiana legislature must amend the senate enrolled act 174. and, similar to indiana’s malicious mischief statute, the legislature should impose a higher criminal penalty for physicians who inseminate their patients with their own improperly screened or infected gametes.266 iv. indiana should adopt a version of the uniform parentage act this section describes the upa and argues that indiana should adopt a version of it. initially, this section describes the upa and explains its statutory scheme. then, this section compares indiana law to the upa and claims that intended parents would be better protected if a version of the upa was implemented. a. the uniform parentage act the upa “is a set of uniform rules for establishing parentage, which may be adopted by state legislatures on a state by state basis.”267 in 1973, the national conference of commissioners on uniform state laws promulgated the first upa.268 this version of the upa “declare[d] equal rights for children regardless 261. see ind. code § 25-1-1.1-2 (2019). 262. see elizabeth j. letourneau et al., evaluating the effectiveness of sex offender registration and notification policies for reducing sexual violence against women, med. u.s.c. (sept. 2010), https://www.ncjrs.gov/pdffiles1/nij/grants/231989.pdf [https://perma.cc/7cqe-5a4l]. 263. see ind. code § 35-42-4-1 (2019). 264. see joshua dressler & stephen p. garvey, cases and materials on criminal law 30-51 (west academic publishing, 7th ed. 2016) 265. see ind. code § 34-24-5-2 (2019). 266. see ind. code § 35-45-16-2 (2019). 267. uniform parentage act law and legal definition, uslegal, https://definitions. uslegal.com/u/uniform-parentage-act/ [https://perma.cc/vyd5-2zjg] (last visited feb. 1, 2020). 268. david l. faigman et al., modern scientific evidence: the law and science of expert testimony § 31:8 (2019-2020 ed. 2019). 2021] daddy doctor 149 of their parents’ marital status.”269 at the time, several states discriminated against illegitimate children.270 in fact, these children were often deemed non-persons with no legal right to paternal support and unable to inherit from relatives.271 through the late 1960s and early 1970s, the supreme court of the united states (the “supreme court”) struck these notions down in gomez v. perez and stanley v. illinois.272 the supreme court began asserting that discrimination of illegitimate children was unconstitutional on equal protection grounds.273 the upa was introduced soon thereafter, and it was implemented by nineteen states in some manner.274 during the early 2000s, the upa underwent its first substantial revision.275 this update “added a streamlined, administrative voluntary acknowledgment of paternity process for establishing parentage of nonmarital children as well as provisions regarding genetic testing.”276 additionally, it revised the upa’s provisions concerning art and added a provision on surrogacy agreements.277 these provisions recognized the parentage of children born from surrogacy agreements.278 because surrogacy was a new process at the time, only eleven states adopted some form of the 2002 upa.279 the upa was most recently updated in 2017 in response to the supreme court’s ruling in obergefell v. hodges, which recognized the fundamental right of same-sex couples to marry.280 while this new update’s central impulse was to revise the upa to better protect children of same-sex couples, it also revised the upa’s surrogacy provisions and added new provisions that addressed the rights of donor-conceived children.281 the 2017 update revised the upa in five essential ways.282 however, only one revision is fundamental for this note: the introduction of article 9, which “addresses the right of children born through [art] to access medical and identifying information regarding any gamete 269. see uniform parentage act law and legal definition, supra note 267. 270. courtney g. joslin, uniform parentage act (2017): what you need to know, a.b.a. (may 11, 2018), https://www.americanbar.org/content/dam/aba/events/family_law/2018/16uniform parentage.pdf [https://perma.cc/ffn2-mvg8]. 271. solangel maldonado, illegitimate harm: law, stigma, and discrimination against nonmarital children, 63 fla. l. rev. 345, 350 (2011). 272. see gomez v. perez, 409 u.s. 535 (1973); stanley v. illinois, 405 u.s. 645 (1972). 273. maldonado, supra note 271, at 351. 274. faigman et al., supra note 268. 275. id. 276. joslin, supra note 270, at 1. 277. melissa henig, what is the legal definition of a parent under the uniform parentage act?, lawyers.com, https://www.lawyers.com/legal-info/family-law/paternity/legal-definitionparent-under-uniform-parentage-act.html (last visited feb. 1, 2020) (copy on file with the author). 278. id. 279. id.; faigman et al., supra note 268, at n.2. 280. faigman et al., supra note 268; see obergefell v. hodges, 135 s. ct. 2584 (2015). 281. henig, supra note 277; joslin, supra note 270. 282. faigman et al., supra note 268. 150 indiana health law review [vol. 18:123 providers.”283 specifically, article 9 provides that a gamete bank or fertility clinic must collect identifying donor information and medical history at the time of donation.284 identifying information includes one’s full name, birth date, permanent address, and current address.285 on the other hand, medical history involves any present and past illness of the donor in addition to the family, social, and genetic histories of the donor.286 in addition, article 9 specifies that, upon request, a gamete bank or fertility clinic must make a good-faith effort to provide a donor-conceived child with his or her donor’s identifying information if the child is at least eighteen years of age.287 if a donor-conceived child is under eighteen years of age, then a gamete bank or fertility clinic must make a good-faith effort to provide the child’s parent or guardian with access to the donor’s nonidentifying medical history.288 finally, with respect to recordkeeping, article 9 requires a gamete bank or fertility clinic to collect and maintain each gamete donor’s identifying information and medical history.289 moreover, in accordance with federal and state laws, a gamete bank or fertility clinic must collect and maintain gamete screening and testing records as well as comply with reporting requirements.290 b. the uniform parentage act and indiana this subsection argues that the indiana legislature should adopt a version of the upa. first, it compares indiana law and the upa. then, it explains how intended parents are better protected if a version of the upa is adopted in indiana. 1. comparing indiana law and the upa thus far, only four states have enacted the 2017 upa, while six others are 283. joslin, supra note 270, at 9 (emphasis omitted). 284. unif. parentage act § 903 (nat’l conference of comm’rs on unif. state laws 2017). 285. unif. parentage act § 901 (nat’l conference of comm’rs on unif. state laws 2017). 286. id. 287. unif. parentage act § 905 (nat’l conference of comm’rs on unif. state laws 2017). 288. id. 289. unif. parentage act § 906 (nat’l conference of comm’rs on unif. state laws 2017). 290. id. 2021] daddy doctor 151 introducing it.291 unfortunately, indiana is not one of these states.292 though, article 9 of the upa and indiana law are alike in some ways. similar to article 9, indiana requires that practitioners obtain the following information from sperm donors: (1) name, (2) address, (3) birth date, and (4) social security number.293 a practitioner is a person who “performs donor insemination” or “receives, processes, or stores semen intended for donor insemination.”294 indiana’s requirements are similar to article 9 in that they obligate gamete banks or fertility clinics to acquire identifying information on sperm donors. additionally, comparable to the recordkeeping provision in article 9, indiana practitioners must keep records of identifying information and the results of mandated testing.295 alternatively, unlike article 9, indiana does not require gamete banks or fertility clinics to obtain a sperm donor’s medical history.296 further, indiana does not provide for donor-conceived children or intended parents to access a sperm donor’s identifying or medical information.297 even previously proposed law, such as indiana’s failed gamete donation act, did not allow for this access.298 2. adopting a version of the upa better protects indiana intended parents although indiana recently implemented the senate enrolled act 174 and has laws aimed at gamete donation, the state’s fertility industry, in general, is still largely unregulated.299 therefore, the indiana legislature must ensure that the state’s laws are wholly protecting the interests of families created by gamete donation. as discussed above, intended parents have an interest in receiving properly screened gametes.300 indiana, currently, only tests sperm donations for communicable or sexually transmitted infections.301 though, a physician may order more tests for a donor “to rule out the presence of [other] infectious disease[s].”302 adopting article 9 would expand this area of indiana law. for example, it would require the collection of a sperm donor’s full medical history, 291. parentage act, uniform l. comm’n, https://www.uniformlaws.org/committees/ com m u n ity-h ome?c om m u n itykey= c4 f3 7 d2 d-4d20-4be0 -8 2 5 6 -2 2 dd7 3 af0 6 8 f [https://perma.cc/rp36-7blg?type=image] (last visited aug. 20, 2020). 292. id. 293. ind. code § 16-41-14-12 (2019). 294. ind. code § 16-41-14-4 (2019). 295. see ind. code § 16-41-14-14 (2019). 296. see generally ind. code § 16-41-14-1 to -20 (2019). 297. see generally id. 298. see supra section ii. 299. see id. 300. see supra section iii. 301. see ind. code § 16-41-14-6 (2019); see 410 ind. admin. code § 25-2-2 (2019). 302. 410 ind. admin. code § 25-2-4 (2019) (emphasis added). 152 indiana health law review [vol. 18:123 including present and past illnesses.303 moreover, under article 9, a sperm donor’s genetic history must be collected.304 with respect to receiving properly screened gametes, this addition to indiana law would allow intended parents to confirm a donor’s identity, his physical resemblance to the husband, and his disease-free status.305 therefore, this addition would better protect intended parents from fertility fraud, sperm bank negligence, and donor dishonesty.306 also, the implementation of article 9’s recordkeeping provision would likely have the same effect on the interests of intended parents. adopting article 9 would better protect intended parents by increasing regulation and oversight of the indiana fertility business. these heightened procedures would probably have a deterrent effect on future fertility fraud perpetrators. they could also remedy sperm bank negligence or misrepresentation cases.307 for instance, in cline’s case, there were no regulations that required sperm donations to be properly tested during his period of misconduct.308 this lack of oversight likely emboldened cline and other fertility fraud perpetrators to illicitly inseminate their own patients because, in the end, who would find out? aside from any current law in place, allowing donor-conceived children or intended parents to access a donor’s identifying or medical information would formally answer this question. v. conclusion fertility fraud is a serious violation. specifically, the wrongful practice shatters personal identity and has destroyed families.309 hoosiers personally felt these effects when the reality of illicit insemination hit close to home in 2017. by 2019, indiana enacted a fertility fraud law to hold illicit inseminators, like cline, accountable for their misconduct.310 the number of fertility fraud cases and incidents of sperm bank negligence is growing.311 such reveals a significant problem with the united states fertility industry, and, in cline’s case, the indiana fertility industry. as a result, the following question is posed: should the indiana fertility business be more 303. unif. parentage act § 901 (nat’l conference of comm’rs on unif. state laws 2017). 304. id. 305. see understanding illicit insemination, supra note 27, at 169. 306. see harnicher v. univ. of utah med. ctr., 962 p.2d 67, 72 (utah 1998) (rejecting an intended parent’s claim for emotional distress after a donor mix-up ruined his chances of resembling the donor-conceived child). 307. see generally id. at 72; see generally zelt v. xytex corp., 766 f. app’x 735, 739, 741 (11th cir. 2019). 308. understanding illicit insemination, supra note 27, at 169. 309. id. at 113; fox et al., supra note 14. 310. h.b. 1369, 121st gen. assemb., 1st reg. sess. (ind. 2019). 311. mroz, supra note 22. 2021] daddy doctor 153 regulated to better protect the interests of intended parents? the answer is yes. although indiana’s fertility fraud law may be the first of its kind,312 the indiana legislature should implement a more stringent criminal penalty in order to better protect intended parents in the state. the benefits of adopting such a penalty are illustrated by comparing the senate enrolled act 174 to gaps in indiana law and examining the act in light of the interests of intended parents. additionally, adopting a version of the upa will improve protections for indiana intended parents. for example, in comparison to current indiana law, the upa’s provisions regarding gamete donation are extensive and may assist in holding illicit inseminators or negligent sperm banks more accountable. because technology will continue to reveal fertility fraud or sperm bank negligence,313 the indiana legislature must take appropriate measures to combat it. while the senate enrolled act 174 is a step in the right direction, there is still room for improvement. 312. zhang, supra note 8. 313. see garrett, supra note 15; fox et al., supra note 14. indiana health law review volume xix 2022 number 1 articles two roads converged in a legal wood: the intersection of litigation funding and the false claims act erik fuqua* i. introduction in robert frost’s famous poem, the road not taken, a traveler encounters a fork in the road and chooses “the one less traveled by,” which “made all the difference.” today’s false claims act (“fca”) traveler encounters the opposite: the convergence of the well-worn roads of litigation funding and the fca. this development has created new concerns in the fca community. will litigation funding alter the path of the fca road? must the fca road be cleansed of litigation funding to remain stable? or is it possible that the convergence, though initially bumpy, can continue smoothly into the horizon? the following hypothetical scenario illustrates how this convergence often occurs in practice: leslie is an lpn who works at a nursing home in a small town. she is twenty-four, single, and has two young children. she makes $40,000 a year and depends on her employment to provide for her family. she has lived in her small town her entire life, and most of her extended family lives there as well. lately, she has become concerned with the level of care the nursing home has been providing to residents. also, leslie’s friend who works in accounting tells her that the nursing home overbilled medicare by $300,000 last year. she told leslie that the administrator, who is close friends with the owner, hired an accountant friend to falsify records and prepare cost reports to avoid reimbursing medicare for the overbilled amount. leslie’s friend suspects this practice has been going on for a few years and that the owner engages in similar practices with the other nursing homes he owns. leslie is deeply troubled by this information, but she * major erik t. fuqua, usaf, (ll.m. 2021, the george washington university law school; j.d. 2011, baylor law school; b.a. 2006, the university of tennessee-martin) is an acquisitions attorney at robins air force base, georgia. major fuqua previously served as a medical law consultant at keesler medical center, keesler air force base, mississippi. he is a member of the tennessee bar. all statements of fact, opinion, or analysis expressed are those of the author and do not reflect the official positions or views of the department of defense (“dod”), united states air force, or any other u.s. government agency. nothing in the contents should be construed as asserting or implying u.s. government authentication of information or dod or air force endorsement of the author’s views. 2 indiana health law review [vol. 19:1 does not know how to respond. a short time later, this issue comes up during a home visit with her pastor and a deacon from her local church. the deacon, who is also a local attorney, puts her in touch with a friend who is a relator’s counsel. leslie calls the relator’s counsel, and he informs her of the false claims act’s qui tam provisions. the relator’s counsel believes that leslie has a good qui tam case with a reasonable likelihood of obtaining a significant recovery if she pursues the case. however, leslie is uncomfortable with the fact that the case may take years to resolve, and she is concerned with the broader reputational consequences of pursuing the case. she is also concerned with the costs of litigation for which she may be liable. the relator’s counsel informs her that companies exist that will provide her a degree of financial support in exchange for a percentage of her recovery. she contacts one of these companies and decides that their financial support will alleviate most of her concerns. she signs a litigation funding agreement with the company, and her relator’s counsel soon files her qui tam case. shortly thereafter, while discussing her decision with her mother, she mentions that she would have walked away from the case had the financial support not been available. the service leslie used is commonly known today as third-party litigation funding. this funding has existed for years, but it recently received attention in the fca community in ruckh v. salus rehab., llc. in ruckh, the eleventh circuit held that a relator’s assignment of a portion of the qui tam bounty did not negate her standing or violate the fca.1 ruckh quickly prompted concerns that its support for litigation funding would lead to a surge in fca cases and otherwise threatened the structure of the fca.2 the purpose of this article is not to assess the validity of litigation funding in general. plenty of others have engaged in that assessment.3 instead, this article will explore the concerns associated with litigation funding, as well as the older doctrines of champerty and maintenance, then view those concerns through an fca lens. part ii of this article will provide a basic overview of the history of 1. ruckh v. salus rehab., llc, 963 f.3d 1089, 1101-03 (11th cir. 2020). 2. see, e.g., daniel wilson, 3rd-party funding ruling opens door for fca case flood, law360 (july 27, 2020, 10:10 pm), https://www.law360.com/articles/1295611/3rd-party-fundingruling-opens-door-for-fca-case-flood [https://perma.cc/57zc-fp5f]; and david jochnowitz & stephen hasegawa, litigation funding attacks pose threat to fca, law360 (aug. 21, 2020, 6:47 pm), https://www.law360.com/articles/1302641/litigation-funding-attacks-pose-threat-to-fca [https://perma.cc/emy5-bnhr]. 3. see, e.g., anthony j. sebok, the inauthentic claim, 64 vand. l. rev. 61 (2011); jeremy kidd, to fund or not to fund: the need for second-best solutions to the litigation finance dilemma, 8 j.l. econ. & pol’y 613 (2012); christy b. bushnell, champerty is still no excuse in texas: why texas courts (and the legislature) should uphold litigation funding agreements, 7 hous. bus. & tax l.j. 358, 364 (2007); jason lyon, revolution in progress: third-party funding of american litigation, 58 ucla l. rev. 571 (2010); lee t. nutini & luke s. smith, perfect civil enforcement? litigation financing in the wake of gawker media v. bollea, 18 transactions: tenn. j. bus. l. 169 (2016); and jonathan t. molot, the feasibility of litigation markets, 89 ind. l.j. 171 (2014). 2022] two roads converged in a legal wood 3 both the fca and litigation funding. part iii will look more closely at the appropriate analysis for litigation funding in fca cases, applying principles from both champerty and maintenance jurisprudence and fca jurisprudence. part iii will then explain why litigation funding is consistent with the fca’s principles and furthers its objectives and will conclude by proposing a framework for the department of justice (“doj”) to use when assessing the impact of litigation funding in fca cases. it will also propose simple amendments to both the federal rules of civil procedure and the fca itself that will address litigation funding opponents’ concerns. ii. the long and winding roads a. the history of the false claims act’s qui tam provisions congress passed the fca in 1863 during the civil war.4 though it has evolved over the years, it remains the united states’ primary fraud-fighting tool. the fca tasks the attorney general with pursuing fca violations,5 but qui tam actions have been central to the act since its inception. a qui tam action is simply a lawsuit brought by a private citizen, commonly called a “whistleblower,” on behalf of the government in exchange for a share of the proceeds, or a “bounty.”6 the fca uses its qui tam provisions “to deputize an army of insiders to uncover, inform, and pursue those government contractors who knowingly cheat in their agreements with the government.”7 initially the act was used to combat war fraud related to goods such as defective rifles and gunpowder, but it was used sparingly in the years following the civil war.8 the act began gaining traction in the 1930s when plaintiffs started using publicly available criminal fraud indictments to file civil qui tam suits.9 concerns with this practice reached a boiling point after united states ex rel. marcus v. hess, where the supreme court upheld the practice despite opposition from the doj.10 hess prompted the attorney general to seek repeal 4. for a thorough discussion of the history of the false claims act, see john t. boese & douglas w. baruch, civil false claims and qui tam actions ch. 1 (5th ed. 2020). it is currently codified at 31 u.s.c. §§ 3729-3733. 5. see 31 u.s.c. § 3730(a). 6. qui tam actions are not limited to the fca, and they predate the fca by several centuries, starting in early english law. for a more thorough historical overview of qui tam, see generally the history and development of qui tam, 1972 wash. u. l. rev. 81. the phrase is an abbreviation of the longer phrase qui tam pro domino rege quam pro seipso, which literally means “he who as much for the king as for himself.” id. at 83. 7. see james b. helmer jr., false claims act: incentivizing integrity for 150 years for rogues, privateers, parasites and patriots, 81 u. cin. l. rev. 1261, 1262 (2013). 8. see paul d. carrington, law and transnational corruption: the need for lincoln’s law abroad, 70 law & contemp. probs. 109, 123 (2007). 9. see boese & baruch, supra note 4, at § 1.01 (“the 1863 act did not limit recovery solely to qui tam plaintiffs offering firsthand knowledge of previously unknown fraud. . . .”). 10. see u.s. ex rel. marcus v. hess, 317 u.s. 537 (1943); see also boese & baruch, supra 4 indiana health law review [vol. 19:1 of the act’s qui tam provisions.11 as a result, congress amended the fca in 1943, depriving courts of jurisdiction in cases where the government had prior knowledge of the conduct at issue and reducing the relator’s bounty.12 once again, qui tam actions became dormant until congress revived them in 1986.13 by 1986, the government’s inability to effectively fight fraud solo was in the spotlight. for several years, members of congress and the president had grown increasingly concerned with widespread fraud related to government spending.14 in a 1981 report to congress, the government accountability office (“gao”) analyzed over 77,000 known fraud and related cases from twenty-one federal agencies spanning a two-and-a-half-year period.15 it found that fraud against the government was a widespread problem that impacted every agency and every type of agency activity.16 gao emphasized how widespread fraud threatens “confidence in the government’s ability to efficiently and effectively manage its programs,” threatens the integrity of government programs, and can even threaten public health and safety.17 agencies had weak internal controls, and managers generally lacked concern for fraud.18 further, the doj had limited resources and “had not emphasized the civil aspects of fraud cases” in recent years.19 the senate judiciary committee’s report on the 1986 amendments echoed these concerns.20 as a result, congress amended the fca by guaranteeing the relator a role in the case even if the government intervenes, increasing the relator’s bounty, guaranteeing the relator some portion of the recovery, and adding anti-retaliation provisions.21 congress also modified the prior knowledge limitation, permitting qui tam suits based on publicly disclosed information when the relator is an original source of the information.22 congress amended the fca two more times after 1986, first in 2009 and again in 2010. the fraud enforcement and recovery act of 2009 (“fera”) amendments broadened the scope of the fca’s anti-retaliation protections, yet left the qui tam provisions mostly unchanged.23 two pieces of legislation note 4, at § 1.02. 11. boese & baruch, supra note 4, at § 1.02. 12. id. see also act of december 23, 1943, pub. l. no. 78-213, 57 stat. 608, 609. 13. see boese & baruch, supra note 4, at § 1.02. 14. see id. at §1.04. 15. u.s. gov’t accountability off., amfd-81-57, fraud in government programs: how extensive is it and how can it be controlled? 2 (1981). 16. see id. at 4. 17. see id. at 15. 18. see id. at 16-24. 19. see id. at 28-32. 20. see generally s. rep. no. 99-345 (1986), as reprinted in 1986 u.s.c.c.a.n. 5266. 21. boese & baruch, supra note 4, at § 1.04. 22. see false claims amendments act of 1986, pub. l. no. 99-562, 100 stat. 3153, 3157 (adding 31 u.s.c. § 3730(e)(4)). 23. see generally pub. l. no. 111-21, 123 stat. 1617, 1624-25 (2009), and see boese & baruch, supra note 4, at § 1.09. 2022] two roads converged in a legal wood 5 amended the fca in 2010: the affordable care act (“aca”)24 and the doddfrank wall street reform and consumer protection act (“dodd-frank act”).25 the aca added new limitations to the public disclosure bar for qui tam actions and expanded the original source exception, broadening the pool of potential relators.26 the dodd-frank act restored an earlier definition of protected conduct in the anti-retaliation provisions and added a statute of limitations for retaliation.27 over the years, qui tam actions have solidified their place in fca enforcement. the number of qui tam cases steadily grew beginning in 1987, and the qui tam share of total fca cases surpassed the non-qui tam cases in 1995.28 qui tam cases have continued to account for the majority of fca cases since 1995 and have not dropped below 70% of total cases since 1997.29 total recoveries show a similar trend. since 2000, qui tam recoveries average 75% of total fca recoveries, accounting for $43.7 billion of the $58.2 billion recovered from 2000 through 2020.30 b. the history of third-party litigation funding litigation funding has an even longer history than the fca. concern over the practice dates back centuries to medieval england and the common law doctrines of champerty and maintenance. today, these concepts are often referred to collectively as “assignment,” but historically “maintenance is helping another prosecute a suit [and] champerty is maintaining a suit in return for a financial interest in the outcome.”31 these practices were prohibited due to concerns that they facilitated misuse of the legal system.32 opponents of the practices feared that “the maintainer may, for personal gain, encourage frivolous litigation, incite quarrels, increase damages, resist settlement, or even suppress evidence and witnesses.”33 the prohibition of these practices carried over to the united states, and litigation funding opponents raise similar concerns with the practices today.34 24. see pub. l. no. 111-148, 124 stat. 119, 901-02 (2010). 25. see pub. l. no. 111-203, 124 stat. 1376, 2079 (2010). 26. see john t. boese, review of false claims act developments, in 23rd annual national institute on health care fraud e-15, e-28 (2013), and 124 stat. at 901-02. 27. see boese, supra note 26, at e-29, and 124 stat. at 2079. 28. see false claims act fiscal year 2020 statistics, u.s. dep’t of just. 1 (2020), https://www.justice.gov/opa/press-release/file/1354316/download [https://perma.cc/p88w-m5fw]. 29. see id. at 1-2. 30. see id. 31. in re primus, 436 u.s. 412, 424 n.15 (1978). see also 14 am. jur. 2d champerty, maintenance, etc. § 1 (2021). 32. see susan lorde martin, syndicated lawsuits: illegal champerty or new business opportunity, 30 am. bus. l.j. 485, 487 (1992). 33. id. 34. cf. following the money: should federal law require litigants to disclose litigation funding agreements?, cong. rsch. serv., 1, 1-2 (2018) (“opponents, however, maintain that the ready availability of litigation funding undesirably increases the volume and length of litigation by incentivizing litigants to initiate and prolong lawsuits even where doing so would otherwise not be 6 indiana health law review [vol. 19:1 1. state treatment of champerty and maintenance states neither uniformly adopted nor uniformly implemented champerty and maintenance prohibitions.35 in fact, some states never recognized them. for example, in 1873, the supreme court of texas explained that, while some state legislatures had adopted them by statute, they had never been part of texas law.36 where recognized, the prohibition is statutory in some states and part of the common law in others.37 common law definitions vary, and some states distinguish between an assignment of a claim itself and the assignment of the proceeds of a claim. for example, the north carolina supreme court has held the former to be prohibited and the latter to be permissible.38 other states have recognized the prohibition more broadly, either rejecting or ignoring the claimproceeds distinction altogether.39 in states with common law prohibitions, the trend over time has been towards abrogation. in 1997, the massachusetts supreme court abrogated its common law prohibition against champerty.40 in 2000, the supreme court of south carolina followed massachusetts.41 in 2001, the florida court of appeals reached a similar conclusion.42 most recently, in 2020, the minnesota supreme court abolished its common law prohibition in a case involving a litigation funding contract.43 economically rational.”). 35. see, e.g., paul bond, making champerty work: an invitation to state action, 150 u. pa. l. rev. 1297, 1333-41 (2002). see also saladini v. righellis, 687 n.e.2d 1224, 1225 (mass. 1997) (“the doctrine has a long and, in this country, checkered history.”). 36. see bentinck v. franklin, 38 tex. 458, 473 (1873). 37. see, e.g., miss. code ann. § 97-9-11 (2021); ky. rev. stat. ann. § 372.060 (lexisnexis 2021); and bond, supra note 35, at 1335-36. 38. charlotte-mecklenburg hosp. auth. v. first of ga. ins. co., 455 s.e.2d 655, 657 (n.c. 1995). there is a distinction between the assignment of a claim for personal injury and the assignment of the proceeds of such a claim. the assignment of a claim gives the assignee control of the claim and promotes champerty. such a contract is against public policy and void. the assignment of the proceeds of a claim does not give the assignee control of the case and there is no reason it should not be valid. id. (citations omitted). see also mut. of omaha bank v. kassebaum, 814 n.w.2d 731, 737 (neb. 2012) (“where only the proceeds of the litigation, and not control of the litigation, have been assigned, there is little or no concern of intermeddling as a reason for declining to allow the assignment of the claim.”). 39. see, e.g., quality chiropractic, pc v. farmers ins. co., 51 p.3d 1172, 1176-82 (n.m. app. 2002); and schwartz v. eliades, 939 p.2d 1034, 1036-37 (nev. 1997). see also chun yan dong v. royal crown ins. corp., no. 09-0035, 2010 u.s. dist. lexis 111917, at *55-63 (d. n. mar. i. oct. 18, 2010). 40. see saladini, 687 n.e.2d at 1226. 41. see osprey, inc. v. cabana ltd. pshp., 532 s.e.2d 269, 277 (s.c. 2000). 42. see hardick v. homol, 795 so. 2d 1107, 1111-12 (fla. dist. ct. app. 2001). 43. see generally maslowski v. prospect funding partners llc, 944 n.w.2d 235 (minn. 2020). 2022] two roads converged in a legal wood 7 2. supreme court treatment of champerty and maintenance because champerty and maintenance are most often state law issues, they have no well-developed federal jurisprudence. united states supreme court cases primarily involve either interpreting state champerty law44 or applying limitations imposed by congress on the assignment of certain statutory claims against the united states.45 yet as early as 1893, the court had already acknowledged that “the rigor of [these laws] has been relaxed.”46 sprint communs., co., l.p. v. apcc servs. is the most recent supreme court demonstration of this relaxed rigor.47 the plaintiffs in sprint were a group of “aggregators,” billing and collection firms that had purchased dial-around claims from payphone operators.48 the aggregators had sued various long-distance carriers, including sprint and at&t, in federal court seeking dial-around compensation.49 at&t argued that the aggregators lacked standing under article iii of the constitution.50 thus, the question for the court was whether assignees of a claim for collection have standing.51 the court surveyed the history and tradition of assignment and ultimately concluded that assignees have standing, even when they have no contractual right to any of the proceeds of the assigned claim.52 3. litigation funding as champerty courts tend to view litigation funding agreements as champertous. in maslowski, the minnesota supreme court found a litigation funding contract to be champertous but then abolished the state’s champerty prohibition.53 in boling v. prospect funding holdings, llc, the sixth circuit applied kentucky law to a litigation funding agreement in a diversity case.54 after considering kentucky’s champerty statute and related case law, the court affirmed the district court’s finding that the agreements at issue were void, explaining, “[w]e conclude that the supreme court of kentucky would hold that the agreements violate ky. rev. stat. § 372.060, and that the agreements are inconsistent with kentucky’s public policy.”55 in justinian capital spc v. westlb ag, n.y. branch, the court of 44. see, e.g., watkins v. sedberry, 261 u.s. 571, 576 (1923) (discussing tennessee’s champerty statute). 45. see, e.g., hager v. swayne, 149 u.s. 242, 247-48 (1893). 46. see id. at 248. 47. see generally sprint communs. co., l.p. v. apcc servs., 554 u.s. 269 (2008). 48. id. at 271. 49. id. at 272. 50. id. 51. see id. at 274-75. 52. see id. at 275-85. 53. see maslowski v. prospect funding partners llc, 944 n.w.2d 235, 238 (minn. 2020). 54. see boling v. prospect funding holdings, llc, 771 f. app’x 562, 577 (6th cir. 2019). 55. see id. at 577-82. 8 indiana health law review [vol. 19:1 appeals of new york similarly held that a litigation funding arrangement was champertous and thus prohibited by the state’s champerty statute.56 iii. two roads converge a. litigation funding in fca cases litigation funding recently gained the fca spotlight in ruckh v. salus rehab., llc.57 the ruckh relator had assigned a small percentage of her bounty to a third-party funder.58 the appellee argued that the funding arrangement was a partial reassignment of the relator’s interest that violated the constitution and the fca and which ultimately forfeited her standing.59 the eleventh circuit disagreed, finding that the agreement did not affect the relator’s standing and was not proscribed by the fca.60 the court explained that qui tam relators are partial assignees of the united states and that a relator has standing as long as she remains an assignee of the united states and the united states has in fact suffered an injury.61 the ruckh relator had retained a sufficient interest in the claim to maintain standing since she had assigned less than 4% of the bounty and had retained sole authority over the litigation.62 after the eleventh circuit’s decision, the appellees renewed their argument in a petition for rehearing en banc, focusing specifically on the issue of whether the fca “permits a person who receives a carefully limited statutory assignment to pursue the claims of the united states as a relator to reassign some or all of her interest in the government’s potential recovery to a third party.”63 they described the eleventh circuit’s holding as a “conversion of the fca into a mercenary tool for quasi-criminal enforcement of secret investors’ agendas [that] shatters the statutory partial assignment regime that vermont agency recognized and will inexorably corrupt the core sovereign power of prosecuting the government’s claims.”64 opponents of the practice also quickly expressed concern that the 56. see justinian capital spc v. westlb ag, n.y. branch, 65 n.e.3d 1253, 1257-59 (n.y. 2016). the justinian capital arrangement was not the typical funding arrangement, but it was a sufficiently similar arrangement to demonstrate new york’s classification of third-party funding as champertous. see also lyra gao, litigation funding: the case for new york to revise section 489, colum. undergraduate l. rev. (2020), https://www.culawreview.org/journal/litigationfunding-the-case-for-new-york-to-revise-section-489 [https://perma.cc/h9dz-dpaz]. 57. see ruckh v. salus rehab., llc, 963 f.3d 1089 (11th cir. 2020). 58. id. at 1100. 59. id. 60. see id. at 1101-02. 61. see id. at 1101 (citing vt. agency of nat. res. v. united states ex rel. stevens, 529 u.s. 765, 773 (2000)). 62. see id. at 1101-02. 63. petition for rehearing en banc at 1, united states ex rel. ruckh v. salus rehab., llc, no. 18-10500 (11th cir. filed july 16, 2020). 64. id. at 3 (citing vt. agency of nat. res. v. united states ex rel. stevens, 529 u.s. 765 (2000)). 2022] two roads converged in a legal wood 9 holding would prompt “litigation driven by desires such as funding cases against competitors” and “could potentially strain courts and the doj’s resources.”65 they noted that third-party funders may not share the same goal as relators, and emphasized the importance of the motivations of the relator.66 are these concerns valid? the following section discusses the broader policy perspectives behind these concerns and the impact of the contemporary legal environment on them. b. policy perspectives the best approach to litigation funding agreements generally is to ask whether they are “opposed to any rule of law or public policy,”67 and the fca itself must provide the primary guidance on how this funding fits within fca cases. however, contemporary treatment of champerty and maintenance can assist with the analysis insofar as it demonstrates how this funding fits within current public policy. while a full discussion of the pros and cons of litigation funding is beyond the scope of this article, a brief survey of the various perspectives will assist the analysis by illustrating the pertinent policy considerations. some proponents of litigation funding point to its ability to level the playing field between often cash-strapped plaintiffs and wealthy, corporate defendants.68 it helps ensure “that justice, although blind, is not also a beggar.”69 others point to broader concepts such as duties owed by a defendant to a plaintiff and the nature of a plaintiff’s right to seek redress.70 for example, as one scholar explained, “the right to seek redress was a product of the wrongdoing, and it is not clear why the right-holder cannot do what she wants with that rightdestroy it, ignore it, or give it to someone else. the normative fact that gave rise to the right will not be undermined, and it is not clear why the courts should not respect the sovereignty of the right-holder to exercise unlimited control over that right.”71 the supreme court demonstrated a similar perspective in sprint when it rhetorically asked, “what does it matter what the aggregators do with the money afterward?”72 opponents to litigation funding continue to voice the same concerns that champerty and maintenance opponents have voiced for centuries. yet, as discussed above, courts and scholars have recognized for at least the past hundred 65. see wilson, supra note 2. 66. see id. 67. cf. hager v. swayne, 149 u.s. 242, 248 (1893). 68. bushnell, supra note 3. 69. id. 70. see sebok, supra note 3, for a very thorough and fascinating discussion of these broader principles. 71. see id. at 133. 72. see sprint communs. co., l.p. v. apcc servs., 554 u.s. 269, 287 (2008). 10 indiana health law review [vol. 19:1 years or more that these concerns are misplaced in american society or have been adequately neutralized through other means. one common concern is that litigation funding will flood the courts with frivolous lawsuits, but sufficient checks exist today to neutralize this threat. senator william langer’s comments from the 1943 amendment debates still apply: “i submit that before any man can recover anything for himself he must go before a court and jury. how can that be a racket?”73 further, modern laws governing conduct such as abuse of process and malicious prosecution also address these concerns.74 finally, from a practical economic perspective, it is unlikely that funding companies would habitually waste money on frivolous lawsuits. as with any investment, funders would likely look for cases that provide a reasonably likely return on investment. thus, if the concern really is frivolous lawsuits, these funders play a role in ensuring that only the meritorious cases are filed. courts that have rejected champerty and maintenance prohibitions also address these concerns. the massachusetts supreme court explained, “we have long abandoned the view that litigation is suspect, and have recognized that agreements to purchase an interest in an action may actually foster resolution of a dispute.”75 the court was “no longer. . .persuaded that the champerty doctrine is needed to protect against the evils once feared: speculation in lawsuits, the bringing of frivolous lawsuits, or financial overreaching by a party of superior bargaining position. there are now other devices that more effectively accomplish these ends.”76 the supreme court of south carolina similarly explained that “other well-developed principles of law can more effectively [address these concerns].”77 the minnesota supreme court, addressing these prohibitions in the context of a litigation funding agreement, explained, “our review of changes in the legal profession and in society convinces us that the ancient prohibition against champerty is no longer necessary.”78 united states supreme court case law also provides some insight into how to consider these concerns. sprint provides a model for determining whether an agreement is “opposed to any rule of law or public policy.”79 the sprint court was not concerned that the plaintiffs would remit the entire litigation proceeds to the non-party assignors: here, a legal victory would unquestionably redress the injuries for which the aggregators bring suit. the aggregators’ injuries relate to the failure 73. 89 cong. rec. 7,607 (1943). 74. see, e.g., hardick v. homol, 795 so. 2d 1107, 1111-12 (fla. dist. ct. app. 2001); and bushnell, supra note 3, at 365. 75. see saladini v. righellis, 687 n.e.2d 1224, 1226 (mass. 1997). 76. see id. at 1226-27. 77. see osprey, inc. v. cabana ltd. pshp., 532 s.e.2d 269, 273-77 (s.c. 2000). see also hardick v. homol, 795 so. 2d 1107, 1111-12 (fla. dist. ct. app. 2001) (following the same rationale to reach a similar conclusion). 78. see maslowski v. prospect funding partners llc, 944 n.w.2d 235, 238 (minn. 2020). 79. see sprint communs. co., l.p. v. apcc servs., 554 u.s. 269, 285-92 (2008); and hager v. swayne, 149 u.s. 242, 248 (1893). 2022] two roads converged in a legal wood 11 to receive the required dial-around compensation. and if the aggregators prevail in this litigation, the long-distance carriers would write a check to the aggregators for the amount of dial-around compensation owed. what does it matter what the aggregators do with the money afterward? the injuries would be redressed whether the aggregators remit the litigation proceeds to the payphone operators, donate them to charity, or use them to build new corporate headquarters.80 despite this broad statement, the court acknowledged that evidence that the assignments were made in bad faith or were made for reasons other than ordinary business purposes may trigger greater scrutiny.81 yet the question remains as to how this general framework aligns with the fca. the following section examines the fca principles relevant to this analysis. c. relevant fca principles 1. qui tam principles judicial and legislative approaches to the fca’s qui tam provisions provide a useful foundation for applying these broader considerations to fca cases. from the fca’s inception, courts have consistently used basic statutory construction principles to analyze qui tam-related issues, focusing on the act’s chief purpose of protecting the government against fraud. one district court concisely described the qui tam provisions’ role in that purpose in an early fca case: it is intended to protect the treasury against the hungry and unscrupulous host that encompasses it on every side, and should be construed accordingly. it was passed upon the theory, based on experience as old as modern civilization, that one of the least expensive and most effective means of preventing frauds on the treasury is to make the perpetrators of them liable to actions by private persons acting, if you please, under the strong stimulus of personal ill will or the hope of gain.82 courts have thus been hesitant to impose restrictions on relators beyond those clearly articulated in the act. marcus v. hess illustrates this approach.83 when the government and respondents argued that the relator had contributed nothing and merely based his case on a previous criminal indictment, the court focused on the scope of the qui tam provisions – suits could be brought by any person – and the corresponding monetary incentives.84 ultimately, it was congress’s job to address the government’s broader public policy concerns.85 courts continue to follow this 80. id. at 286-87. 81. see id. at 292. 82. united states v. griswold, 24 f. 361, 366 (d. or. 1885). 83. see, e.g., united states ex rel. marcus v. hess, 317 u.s. 537, 545-48 (1943). 84. see id. at 545-47. 85. id. at 546-47. 12 indiana health law review [vol. 19:1 approach with qui tam issues.86 from 1986 forward, congress’s intent has been to encourage maximum use of the qui tam provisions. in 1986, it effectively acknowledged the failure of the 1943 amendments to adequately protect the government from fraud. the senate judiciary committee report explained that the 1986 amendments were meant to “enhance the government’s ability to recover losses sustained as a result of fraud against the government.”87 it reaffirmed the importance of the qui tam provisions in meeting the act’s objectives, explaining that “only a coordinated effort of both the government and the citizenry will decrease this wave of defrauding public funds.”88 the committee’s goal was “to encourage more private enforcement suits.”89 the 2009 and 2010 amendments advanced this goal by strengthening the anti-retaliation provisions and expanding the pool of relators.90 2. standing principles the supreme court’s analysis of relator standing also informs the analysis of litigation funding in fca cases. in vermont agency, the supreme court based qui tam relator standing on the doctrine of assignment.91 the court explained that the fca’s qui tam provisions are a partial assignment of the government’s claim based on an injury in fact to the united states.92 again, a relator has standing unless the facts show that the relator is no longer an assignee of the united states or that the united states did not suffer an injury.93 the ruckh appellees emphasized vermont agency’s assignment characterization, but they failed to distinguish between an interest in the claim itself and an interest in the proceeds of the claim. vermont agency explained that the fca “gives the relator himself an interest in the lawsuit, and not merely the right to retain a fee out of the recovery.”94 the ruckh appellees argument that the fca does not permit relators to reassign the government’s claims to third parties conflates the claim with the proceeds. courts have historically recognized this 86. see, e.g., united states ex rel. holmes v. consumer ins. grp., 318 f.3d 1199, 1208-12 (10th cir. 2003); and united states ex rel. hagood v. sonoma cnty. water agency, 929 f.2d 1416, 1419-20 (2d cir. 1991). see also united states ex rel. milam v. univ. of tex. m.d. anderson cancer ctr., 961 f.2d 46, 49 (4th cir. 1992) (“congress has let loose a posse of ad hoc deputies to uncover and prosecute frauds against the government. [defendants] may prefer the dignity of being chased only by the regular troops; if so, they must seek relief from congress.”). 87. s. rep. no. 99-345 (1986), as reprinted in 1986 u.s.c.c.a.n. 5266, *5266. 88. see id. at *5267. 89. s. rep. no. 99-345, at 23-24 (1986), as reprinted in 1986 u.s.c.c.a.n. 5266, 5288-89. 90. see h.r. rep. no. 111-97, at 2 (2009); and boese, supra note 26, at e-28. 91. see vt. agency of nat. res. v. united states ex rel. stevens, 529 u.s. 765, 770-87 (2000). 92. see id. at 773-74. 93. ruckh v. salus rehab., llc, 963 f.3d 1089, 1101 (11th cir. 2020). 94. see vt. agency of nat. res., 529 u.s. at 772 (emphasis in original). 2022] two roads converged in a legal wood 13 distinction,95 including the supreme court in sprint.96 in fact, sprint effectively held that a plaintiff need only an interest in the claim and could assign the entire interest in the proceeds to a third-party.97 typical litigation funding situations are not so extreme: the relator retains an interest in the claim and merely assigns a portion of the recovery. 3. fca principles applied to litigation funding the fca’s qui tam provisions are built upon the general concepts of a broad relator pool and monetary incentives. the act began with no restrictions on who could serve as a relator.98 after marcus v. hess, congress added the prior knowledge limitation.99 but when faced with pervasive fraud and the government’s inability to fight it alone, congress revitalized the qui tam provisions in 1986 and expanded the pool of relators.100 in 2010, congress expanded the pool further.101 since 1986, congress has consistently sought to only further incentivize relators to come forward through increased bounties and stronger whistleblower protections. this is the fca path into which the litigation funding path has merged. these fca principles are consistent with the broader principles that have motivated courts to abolish or reject laws prohibiting champerty and maintenance. congress wants more relators to come forward, and it continues to incentivize relators to do so. litigation funding supports that goal by mitigating the initial risks and barriers average citizens often face.102 nothing in the act suggests that 95. see, e.g., charlotte-mecklenburg hosp. auth. v. first of ga. ins. co., 455 s.e.2d 655, 657 (n.c. 1995). 96. sprint communs. co., l.p. v. apcc servs., 554 u.s. 269, 280-81 (2008). 97. see id. at 289, and id. at 298 (“the majority concludes that a private litigant may sue in federal court despite having to pass back . . . all proceeds of the litigation. . . .”) (roberts, c.j., dissenting). 98. cf. united states ex rel. marcus v. hess, 317 u.s. 537, 546 (1943) (“suits may be brought and carried on by ‘any person,’ says the act, and there are no words of exception or qualification such as we are asked to find.”). “even the district attorney” could be a relator. see id. (quoting cong. globe, 37th cong., 3rd sess. 955, 956). 99. see boese & baruch, supra note 4, at § 1.02; and act of december 23, 1943, pub. l. no. 78-213, 57 stat. 608, 609. 100. see false claims amendments act of 1986, pub. l. no. 99-562, 100 stat. 3153, 3157 (adding 31 u.s.c. § 3730(e)(4)); and hughes aircraft co. v. united states ex rel. schumer, 520 u.s. 939, 950 (1997) (“in permitting actions by an expanded universe of plaintiffs with different incentives, the 1986 amendment essentially creates a new cause of action, not just an increased likelihood that an existing cause of action will be pursued.”). 101. see boese, supra note 26, at e-28. 102. cf. metropolitan life ins. co. v. fuller, 23 a. 193, 196 (conn. 1891) (“it sometimes may be useful and convenient, when one has a just demand which he is not able from poverty to enforce, that a more fortunate friend should assist him, and wait for his compensation until the suit is determined, and be paid out of the fruits of it.”). 14 indiana health law review [vol. 19:1 congress is concerned with what the relator does with the bounty. unless facts exist to indicate the funding agreement is somehow unscrupulous, courts should not be concerned either.103 to the extent questionable agreements may exist, the doj can assess the impact of them in the context of its existing qui tam case review process. d. a proposed doj review framework the doj can implement a review framework to adequately address concerns related to litigation funding in fca cases. it has already begun publicly acknowledging these concerns. in january 2020, deputy associate attorney general stephen cox briefly touched on litigation funding during a public address, explaining that the doj was evaluating the proposed legislation and amendments to the federal rules of civil procedure and related concerns.104 in june 2020, principal deputy assistant attorney general ethan davis mentioned it as well in a similar forum.105 mr. davis acknowledged that “the united states has an interest in knowing who is behind [qui tam cases]” and explained that doj attorneys had been instructed to begin asking questions about litigation funding during relator interviews.106 the doj can use reasonable scrutiny to address litigation funding concerns in fca cases.107 it has already begun asking “for the identity of the funder, whether the relator has shared information relating to the qui tam allegations with the funder, whether a written agreement exists, and whether the agreement entitles the funder to exercise any direct or indirect control over the relator’s litigation or settlement decisions.”108 it should also consider what share of the bounty the relator has assigned to the funder and the relationship between the 103. cf. sprint communs. co., l.p. v. apcc servs., 554 u.s. 269, 287 (2008) (“finally, we note that in this litigation, there has been no allegation that the assignments were made in bad faith. we note, as well, that the assignments were made for ordinary business purposes. were this not so, additional prudential questions might perhaps arise.”). 104. see press release, deputy associate attorney general stephen cox provides keynote remarks at the 2020 advanced forum on false claims and qui tam enforcement, u.s. dep’t of just. (jan. 27, 2020), https://www.justice.gov/opa/speech/deputy-associate-attorney-generalstephen-cox-provides-keynote-remarks-2020-advanced [https://perma.cc/fkf8-8hns] (the proposed legislation and rules amendments are discussed below. they never progressed beyond the proposal stage.). 105. see press release, u.s. dep’t of just. principal deputy assistant attorney general ethan p. davis delivers remarks on the false claims act at the u.s. chamber of commerce’s institute for legal reform, u.s. dep’t of just. (june 26, 2020), https://www.justice.gov/civil/speech/ principal-deputy-assistant-attorney-general-ethan-p-davis-delivers-remarks-false-claims [https://perma.cc/hs77-krc2]. 106. see id. 107. cf. saladini v. righellis, 687 n.e.2d 1224, 1227 (mass. 1997) (“other states that no longer recognize the doctrine of champerty have continued to scrutinize an agreement to finance a lawsuit with care. . . we shall do likewise.”) (citation omitted). 108. press release, supra note 105. 2022] two roads converged in a legal wood 15 funder and the relator. currently, the doj is focused on gathering information “for the purpose of studying the issues.”109 the following three-part framework should guide how the doj uses this information in practice. first, the doj should ascertain whether the arrangement is subversive or predatory. second, in the event the arrangement appears subversive or predatory, the doj must decide how that determination impacts its decisions related to dismissal and intervention. finally, assuming a case with a potentially subversive or predatory funding arrangement moves forward and results in a settlement or judgment, the doj must decide how the arrangement impacts the relator’s share of recovery. the doj should first determine whether a funding arrangement is subversive or predatory. is the funder effectively attempting to use the relator as a puppet? knowing the share of the bounty will help the doj identify these arrangements in two respects. first, it will provide data that, when aggregated over time, can provide a spectrum of normal percentages assigned. second, it should provide insight into the significance of the relator’s role and whether the funder’s interest in the case is of such a level to be concerning. that said, it is not necessary that the doj attempt to identify some percentage at which an agreement becomes problematic. potentially a relator could assign the entire bounty to a third-party without violating fca principles, though such an arrangement would likely require a more extensive analysis of the other factors.110 understanding the relationship between the relator and the funder is also important for identifying subversive or predatory funding arrangements. this inquiry should focus on how the relator and funder formed their agreement as well as their relationship prior to the agreement. the results of this inquiry should ordinarily address most funding concerns, even those associated with larger than normal assignments. most cases will have similar facts to leslie’s: a relator who came forward on her own initiative, had concerns with the personal financial risk associated with pursuing a qui tam action, was presented with the option of using litigation funding in exchange for a share of the bounty to minimize that risk, and voluntarily chose to enter into that business relationship. these agreements made for ordinary business purposes should not require further analysis.111 this inquiry could also reveal some less common funding arrangements, such as where a friend or family member provided the relator with initial support in exchange for being reimbursed out of any recovery. these situations are unlikely to be concerning. a very small percentage of cases may trigger subversive or predatory concerns. perhaps the funder is the defendant’s competitor and sought the relator out. yet even in these situations, the doj can inquire further to ascertain the ongoing relationship and address any concerns that the funder’s motivations “may 109. id. 110. see ruckh v. salus rehab., llc, 963 f.3d 1089, 1101 (11th cir. 2020) (acknowledging that a more substantial assignment of the bounty could negate the relator’s status as an assignee of the united states for fca purposes). 111. cf. sprint communs. co., l.p. v. apcc servs., 554 u.s. 269, 292 (2008). 16 indiana health law review [vol. 19:1 be at odds with the government’s,”112 to the extent such a divergence is a problem. once the doj has identified whether the funding arrangement appears subversive or predatory, it should factor that determination into its dismissal and intervention analysis. dismissal might be the best response in some cases. the fca allows the government to dismiss qui tam actions over the relator’s objection.113 in some jurisdictions this ability is absolute while others require the doj to provide some justification.114 the dismissal considerations outlined in the doj’s 2018 “granston memo” could encompass suspect funding arrangements, and two of them are especially pertinent. the first is preventing parasitic or opportunistic qui tam actions.115 although the memo’s discussion on this point is narrow, the doj can apply it more broadly to suspect funding situations. for example, perhaps a funder used information already known to the government to track down a relator who could serve as an original source but would not otherwise have pursued a qui tam case absent the funder’s urging. the second consideration is the goal of controlling litigation brought on behalf of the united states.116 though procedurally and statutorily compliant, these cases may nevertheless arise in a way that congress has not anticipated. even in cases with some merit, the doj could reasonably conclude that these sorts of cases frustrate its broader fca-related objectives. on the other hand, even cases with suspect arrangements can expose egregious fraud with the potential for significant recovery for the treasury. these cases likely would not warrant dismissal. in other cases, a suspect funding arrangement could indicate that intervention is more appropriate. admittedly, the doj should not intervene in a case merely because of a questionable funding arrangement, but the existence of such an arrangement should factor into the doj’s analysis. the fca provides the doj with additional tools when it intervenes that should alleviate any concerns related to questionable funding. 31 u.s.c. § 3730(c)(1) grants the government “primary responsibility for prosecuting the action” when it intervenes and states that the government is not bound by the relator’s actions. 31 u.s.c. § 3730(c)(2)(c) 112. cf. petition for rehearing en banc, supra note 63, at 10. 113. see 31 u.s.c. § 3730(c)(2)(a). 114. compare united states ex rel. sequoia v. sunland packing house co., 912 f. supp. 1325, 1345-46 (e.d. ca. 1995) (developing a two-step analysis to test the government’s justification for dismissal), aff’d, united states ex rel. sequoia orange co. v. baird-neece packing corp., 151 f.3d 1139, 1145 (9th cir. 1998), with swift v. united states, 318 f.3d 250, 252 (d.c. cir. 2003) (rejecting sequoia and holding that the government possesses an unfettered right to dismiss a qui tam case). see also united states ex rel. health choice all., l.l.c. v. eli lilly & co., no. 1940906, 2021 u.s. app. lexis 20175, at *22-27 (5th cir. july 7, 2021) (refusing to adopt either test and instead holding that the government met sequoia’s more burdensome test). 115. see memorandum from michael d. granston, dir., fraud section, com. litig. branch, dept. of just., to fraud section att’ys & assistant u.s. att’ys handling false claims act cases (jan. 10, 2018), https://www.insidethefca.com/wp-content/uploads/sites/300/2018/12/granstonmemo.pdf [https://perma.cc/gmv9-ezjj]. 116. see id. at 5. 2022] two roads converged in a legal wood 17 allows the government to limit a relator’s participation when it might interfere with the government’s prosecution of the case or “would be repetitious, irrelevant, or for purposes of harassment.” finally, in cases with suspect arrangements that result in settlement or judgment, the doj should consider the nature of the arrangement when proposing the relator’s share. the senate judiciary committee report to the 1986 amendments proposed three general considerations for determining a relator’s share,117 and the doj has developed its own set of factors that can impact a proposed relator’s share.118 the minimum share is 15% in cases where the government intervenes and 25% when the government does not intervene.119 a suspect funding agreement could weigh against an increase in that share, especially when the relator is more of a puppet and contributed very little to the case. further, one of the doj’s factors for a possible increase is whether the “filing of the complaint had a substantial adverse impact on the relator.”120 even in less concerning funding situations, the funding could have mitigated all or most of this risk, indicating that the bounty played less of an incentive role in encouraging the relator to come forward. e. proposed frcp and fca amendments although litigation funding concerns do not justify an absolute prohibition on the practice, amendments to the federal rules of civil procedure (“frcp”) and the fca itself could help facilitate the government’s review process and address residual concerns. after all, in some cases, relators may not be willing to disclose all the details of their agreements and the doj may not have sufficient legal mechanisms to force them to do so. legislation and frcp amendments to facilitate disclosure of litigation funding agreements have been proposed before. in 2014, several organizations wrote a joint letter to the advisory committee on civil rules urging the committee to adopt an amendment to rule 26(a)(1)(a).121 that amendment would have added a new subparagraph (v) requiring disclosure of agreements granting third parties “a right to receive compensation that is contingent on, and sourced from, any proceeds of the civil action, by settlement, judgment or otherwise.”122 117. see s. rep. no. 99-345 (1986), as reprinted in 1986 u.s.c.c.a.n. 5266, 5293. 118. see doj relator share guidelines, u.s. dep’t just. 1 (dec. 11, 1996), https://www.vsglaw.com/wp-content/uploads/2016/08/doj_relator.pdf [https://perma.cc/32ps-be32]. 119. see 31 u.s.c. § 3730(d). 120. see doj relator share guidelines, supra note 118, at 2. 121. see letter from lisa a. rickard, president, u.s. chamber inst. for legal reform, et al., to jonathan c. rose, sec’y comm. on rules prac. & proc. admin. office of the u.s. ct. (apr. 9, 2014), https://instituteforlegalreform.com/wp-content/uploads/media/4_-_final_version__tplf_disclosure_letter_4_9.pdf. [https://perma.cc/8gtq-jjqk] (rule 26 governs discovery generally, and rule 26(a) governs the initial disclosures parties must make to other parties without the need of a discovery request.). 122. see id. at appendix a. the proposed language excluded attorney contingency fee agreements. 18 indiana health law review [vol. 19:1 a similar group of organizations proposed essentially the same amendment again in 2019.123 also in 2019, the advisory committee on civil rules’ multidistrict litigation (“mdl”) subcommittee considered the role of litigation funding in mdl and concluded that rule amendments were not justified at that time.124 on the legislative front, in february 2019, senator chuck grassley introduced the litigation funding transparency act of 2019.125 the bill died in the senate, but it would have required counsel in class actions and mdl to disclose any agreement with an outside entity that entitled the entity to receive payment contingent on the outcome of the lawsuit.126 disclosure rules, either in the frcp or the fca, would address any ongoing litigation funding concerns. for example, the ruckh appellees emphasized the “secret” nature of these agreements.127 concerns of secrecy in qui tam cases are valid, especially given the united states’ interest in them.128 the recently proposed amendments to rule 26(a)(1)(a) would address these secrecy concerns, though the impact would not be limited to fca cases. some local rules already require these disclosures in certain cases.129 an amendment to rule 26(a)(1)(a) would provide a uniform solution as litigation funding becomes more common,130 though perhaps relevant policy concerns may mitigate against a disclosure requirement in broader civil litigation.131 these broader policy concerns are less relevant in fca cases where the government’s interest is primary, so an fca amendment requiring disclosure would more effectively address the fca-specific concerns. for the fca itself, the litigation funding transparency act of 2019 provides a simple, workable template for an amendment. congress could add the following language as a new paragraph (i) in 31 u.s.c. § 3730: 123. see letter from advanced med. tech. assoc. et al., to rebecca a. womeldorf, sec’y comm. on rules prac. & proc. admin. office u.s. ct. (mar. 27, 2019), https://www.uscourts.gov/ sites/default/files/19-cv-i-suggestion_advanced_medical_et_al_0.pdf [https://perma.cc/56zr-7p39]. 124. meeting minutes for third party litigation financing, advisory comm. on civ. rules, 1, 191 (oct. 29, 2019), https://www.uscourts.gov/sites/default/files/2019-10_civil_rules_agenda_ book.pdf [https://perma.cc/e8h6-lpja]. 125. see generally s. 471, 116th cong. (2019). 126. see id. 127. see generally petition for rehearing en banc, supra note 63, at 1-2. 128. cf. press release, supra note 105 (explaining that the united states has an interest in knowing who is behind qui tam cases). 129. see, e.g., 11th cir. r. 26.1-2(a); n.d. cal. civ. r. 3-15. 130. cf. james anderson, is increased transparency into litigation financing on the horizon?, nat’l l. rev. (jan. 15, 2020), https://www.natlawreview.com/article/increasedtransparency-litigation-financing-horizon [https://perma.cc/eg6y-hz5w] (“the market for litigation finance shows no signs of slowing down . . . .”). 131. see, e.g., matthew harrison & john harabedian, claimants shouldn't be forced to disclose litigation funding, law360 (june 11, 2018), https://www.law360.com/insurance/articles/ 1052279/claimants-shouldn-t-be-forced-to-disclose-litigation-funding [https://perma.cc/mm2fb2cj]. 2022] two roads converged in a legal wood 19 (i) third-party litigation funding disclosure. (a) in general.—in all actions brought under subsection (b), the person bringing the action shall— (1) disclose in writing to the court and all other named parties to the action the identity of any person, other than a party or counsel of record for a party, that has a right to receive payment that is contingent on the receipt of monetary relief in the action by settlement, judgment, or otherwise; and (2) produce for inspection and copying, except as otherwise stipulated or ordered by the court, any agreement creating the contingent right. (b) timing.—the disclosure required by subsection (a) shall be made not later than the later of— (1) 10 days after execution of any agreement described in subsection (a)(2); or (2) the time of service of the action under subsection (b)(2). this requirement would ensure that the doj has sufficient information to evaluate these agreements early while making its intervention and dismissal decisions. iv. conclusion: the roads go ever on though third-party litigation funding and the false claims act each have their own, unique histories and jurisprudence, they can merge smoothly. opponents to litigation funding have reasonable concerns about the practice, but the american legal system has developed protections that already address those concerns. the fca also has its own unique protections against fca-specific concerns. further, litigation funding supports congress’s goals for the fca’s qui tam provisions such as incentivizing whistleblowers to expose fraud against the government. to the extent concerns for litigation funding remain, the doj can use this article’s proposed review framework to identify concerning cases and respond to them appropriately, and congress can amend the fca to facilitate the doj’s review. these actions will maximize the benefits litigation funding provides to the fca while neutralizing any residual concerns. indiana health law review volume xix 2022 number 2 notes dairy beloved: why indiana should stop labeling plant-based beverages as “milk” brooke m. behrens* i. introduction while waiting in line at your favorite local coffee shop, you hear a barista yell out “i have a medium iced, sugar-free vanilla latte with soy milk for megan!” shortly after, you overhear the man in front of you order a “large hot chocolate with coconut milk, hold the whipped cream.” all the while, you are scanning the menu on the wall, debating whether you want almond or oat “milk” in the caramel macchiato you are about to order. despite the differences between these drinks, they all have one thing in common – none of them are milk. the market of non-dairy alternatives in the grocery store or at the local coffee shop seems to be growing by the day. beyond the traditional nonfat and whole milk options that have been around for decades, beverages made out of soy, almonds, rice, cashews, coconut, oats, hemp, hazelnuts, macadamia nuts, flax, peanuts, tiger nuts, walnuts, spelt, quinoa, and even peas, line the shelves of supermarkets across the world.1 if a shopper does not know what they are looking for, it is easy to see how confusing the milk market has become. to add to the issue, these non-dairy alternatives are more often than not found in the same type of carton or bottle as traditional cow’s milk and are sometimes even on the same shelves.2 if a buyer is uninformed about what a product touting the label “almond milk” really means, he may not realize the vast differences that exist between what he is about to buy and what he is probably expecting. these differences include taste, smell, color, overall flavor, consistency, functional properties, and even shelf life.3 the most impactful, and potentially detrimental, difference is the * j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.s. nutrition, 2019, university of minnesota-twin cities. 1. oliver franklin-wallis, white gold: the unstoppable rise of alternative milks, guardian (jan. 29, 2019, 1:00 pm), https://www.theguardian.com/news/2019/jan/29/white-goldthe-unstoppable-rise-of-alternative-milks-oat-soy-rice-coconut-plant [https://perma.cc/9mm4z85g]. 2. see id. 3. see use of the names of dairy foods in the labeling of plant-based products, 83 fed. reg. 49,103, 49,104 (sept. 25, 2018). 400 indiana health law review [vol. 19:399 great disparity in nutritional value between milk and its substitutes.4 the legal and policy battles between the dairy industry and the rising plantbased alternative industry have been increasing over the last few years, especially as concerns for animal ethics, environmental protections, and health issues continue to increase.5 at the center of this ongoing conflict is the vastly different nutritional status and quality of dairy milk and plant-based alternatives. when considered together with the ever-changing ways that consumers view their health and societal trends, the recognition and emphasis of the differences between cow milk and its alternatives is more important now than ever. allowing milk’s plant-based counterparts to be labeled as “milk” is confusing to consumers, especially from a nutritional perspective. the food and drug administration (“fda”) regulates the standard of “milk” and other dairy terms,6 and to allow non-dairy products to be labeled as milk gives a false sense of what is being delivered. the fda does not have specific regulations for plant-based beverages, thus leaving room for nutritional disparities, especially when consumers believe they are getting the same nutrients that dairy milk provides.7 for this reason, any milk alternative product that does not come from a mammal should not be allowed to have the label of “milk” (e.g., “almond milk” or “soy milk”). a. roadmap this note takes the overall position that plant-based alternatives to milk are nutritionally inferior to cow’s milk, and thus should be restricted from using the word “milk” on labels. section ii of this note provides some background information on fda labeling regulations, as well as the dictionary and legal definitions of the word milk. it also includes a discussion of recent trends that have given rise to the increased interest in plant-based beverages. section iii of this note explores the differences in nutritional value between cow’s milk and its various plant alternatives. for purposes of this note, the scope of plant-based beverages was limited to almond, soy, rice, coconut, and oat varieties, as they tend to be the most popular among consumers. then there is a discussion of the key nutrients in milk and how plant-based alternatives compare, followed by a determination of what the “best” and “worst” plant-based beverages are if used to replace milk. then a brief overview of the unique health 4. id. 5. see luca leone, nomen est omen?: on the legal identity of dairy alternatives in the usa, 14 eur. food & feed l. rev. 436 (2019). 6. id. at 443. 7. press release, food & drug admin., statement from fda commissioner scott gottlieb, m.d., on modernizing standards of identity and the use of dairy names for plant-based substitutes (sept. 27, 2018), https://www.fda.gov/news-events/press-announcements/statement-fdacommissioner-scott-gottlieb-md-modernizing-standards-identity-and-use-dairy-names [https://perma.cc/c5jn-vqeg]. 2022] dairy beloved 401 benefits of milk is given. section iv of this note asserts that indiana should adopt legislation similar to the truth in labeling act, that would prevent cow milk alternatives from being labeled as “milk.” it goes through various pieces of legislation that have been introduced and/or passed in various states, as well as a discussion of the dairy pride act that was introduced to congress. this section concludes with an assessment of why it is important that indiana take steps towards passing legislation similar to the truth in labeling act. finally, section v of this note addresses specific recommendations of alternatives indiana can adopt rather than using “milk” on plant-based product labels. it starts with a look at actions taken in canada and europe that indiana and other states could also adopt. this is followed by a series of scenarios and recommendations of creative labeling techniques that do not involve using “milk” in labeling plant-based beverages. ii. background information a. a brief history of food labeling the very beginning of labeling transparency began with the 1906 pure food and drug act, which stated that a food’s label cannot be false or misleading in any way.8 the act also prohibits the interstate transport of food and drug products that may have false or misleading information on the label.9 next came the federal food, drug, and cosmetic act of 1938 (“fdca”), which set forth certain requirements for the quality and identity standards in foods, including milk and other dairy products.10 the fdca also set limits on how a product could be advertised.11 section 401 of the fdca adopted the requirement of standards of identity for numerous foods, including dairy products like milk.12 plant-based alternatives to milk, on the other hand, are not required to meet a standard of identity set out by the fdca.13 section 401 requires that when a food does not have a standard of identity, the label must disclose its common or usual name and its ingredients, if it contains more than one.14 for instance, a product containing both shrimp and cocktail sauce would appropriately be labeled as “shrimp cocktail” rather than just “cocktail” or even “seafood cocktail.”15 the fdca also sets out guidelines for when a food shall be deemed as misbranded. a food is misbranded if its labeling is false or misleading in any 8. pure food and drugs act of 1906, 59 cong. ch. 3915, 34 stat. 768 (1906). 9. id. 10. federal food, drug, and cosmetic act of 1938 § 401, 21 u.s.c. § 341 (1938). 11. id. 12. leone, supra note 5, at 438. 13. see federal food, drug, and cosmetic act of 1938 § 401. 14. leone, supra note 5, at 438. 15. see 21 c.f.r. § 102.54 (2021). 402 indiana health law review [vol. 19:399 way; it is sold under the name of another food; or it imitates another food, unless the label contains the word “imitation” and then immediately thereafter the name of the food it is imitating, such as “imitation crab.”16 a food is considered an imitation of another food when “it is a substitute for and resembles another food but is nutritionally inferior to that food.”17 however, a food does not fall into this category so long as it is not nutritionally inferior and its label has a common name or appropriate descriptive term that is not false and/or misleading.18 a food is considered nutritionally inferior if it has “any reduction in content of an essential nutrient that is present in a measurable amount, but does not include a reduction in the caloric or fat content.”19 a common name of a food includes an indication of the presence or absence of key or characterizing ingredients, specifically when the presence or absence of that component has a bearing on the price or overall consumer acceptance of the product.20 the common name is also required when the label or appearance of a food product has the potential to mislead or create a false impression that a particular ingredient is present in the food when it is in fact not, which could result in the misperception of what the product is to the average consumer.21 the fdca provided a framework for food labelling regulations of all food that is manufactured, distributed, and sold in the united states.22 the regulations required the statement of identity to provide the names of foods, requiring them to be truthful and otherwise not misleading.23 this was the first time congress established the meaning of “imitation” labeling for substitute food products, and mandated how the labeling of such indication must be carried out in a uniform size and prominence.24 b. defining milk the merriam-webster dictionary defines milk as “a fluid secreted by the mammary glands of females for the nourishment of their young.25 furthermore, the legal definition of milk, as set out in the fda regulations, is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”26 this definition also includes goat, sheep, and water buffalo as milk-producing animals when the fda defines “milk products,” and 16. federal food, drug, and cosmetic act of 1938 § 403, 21 u.s.c. § 343. 17. 21 c.f.r. § 101.3 (2021). 18. id. 19. id. 20. 21. c.f.r. § 102.5 (2021). 21. id. 22. leone, supra note 5, at 438. 23. id. 24. id. 25. milk, merriam-webster, https://www.merriam-webster.com/dictionary/milk [https:// perma.cc/rmq2-56l6] (last visited feb. 11, 2021). 26. 21 c.f.r. § 131.110 (2021). 2022] dairy beloved 403 is thus incorporated in the definition of “milk” by reference.27 in both definitions, milk is produced by a mammal, most commonly a cow, and is an important part of the human diet. dictionary definitions of plant-based alternatives to milk are often some variation of “colloidal suspensions or emulsions including dissolved and disintegrated vegetable material” that are “traditionally prepared by milling different raw material in suspension and then by filtering it to remove bigger particles.”28 the fda definition of milk creates a specific standard of identity, setting out specific guidelines for what can and cannot be sold as “milk.”29 these guidelines include specifications of fat content (differentiating between low fat milk, skim milk, cream, etc.), the process of fermentation (cultured or acidified), and the allowed modifications to the chemical and physical characteristics of milk.30 plant-based beverages do not meet these specifications for products that can be called milk, nor do they have their own standard of identity.31 c. trends in milk consumption in the 1970s, the average american drank around thirty gallons of milk a year, which has since declined to around eighteen gallons per year, nearly half the consumption it once was.32 this decline in milk consumption and sales matched with a rise in plant-based alternatives, especially within the past seven or so years.33 in fact, as recently as 2008, alternative drinks to milk were largely made from soy, and were mainly consumed by those who were lactose intolerant or had a milk allergy.34 a boost in the numbers of people straying away from dairy came between 2009 and 2014, around the same time that major social media platforms began to take off.35 instagram feeds quickly began to be filled with pictures of morning lattes and post-workout smoothies. access to numerous “get skinny 27. marina e. moreno & jonathan berman, can nondairy beverages be called milk?, 15 aba scitech l. 24, 26 (2019). 28. elvira verduci et al., cow’s milk substitutes for children: nutritional aspects of milk from different mammalian species, special formula and plant-based beverages, 11 nutrients 1, 11 (2019). 29. see 21 c.f.r. § 131.110 (2021). 30. see moreno & berman, supra note 27. 31. see id. 32. nellie bowles, got milk? or was that really a plant beverage?, n.y. times (aug. 31, 2018), https://www.nytimes.com/2018/08/31/business/milk-nut-juice-plant-beverage-label.html [https://perma.cc/28l4-t7zg]. 33. lauren sipple, what’s in a name?: the use of dairy product names in labeling of plant-based alternatives, sci. meets food (dec. 13, 2018), https://sciencemeetsfood.org/whatsname-use-dairy-product-names-labeling-plant-based-alternatives/ [https://perma.cc/c4ls-qgap]. 34. franklin-wallis, supra note 1. 35. bee wilson, why we fell for clean eating, guardian (aug. 11, 2017), https://www. theguardian.com/lifeandstyle/2017/aug/11/why-we-fell-for-clean-eating [https://perma.cc/95lep2r2]. 404 indiana health law review [vol. 19:399 quick” methods promoted by celebrities were available at the touch of a button, and “hashtag veganism” began trending on twitter. people soon began to crave new ways of following these newly sparked health crazes.36 one of the biggest targets of this social media madness: milk.37 around this same time, health documentaries started gaining attention, which again put the spotlight on things like fast food companies and the meat and dairy industries.38 this brought an increase in concern of the conditions dairy cows were working in, as well as whether pesticides or antibiotics were in the food the cows were fed.39 when considered together with the negative media portrayal of the environmental impacts that the meat and dairy industries were rumored to have, consumers became increasingly wary of the milk they had been drinking for their entire lives.40 the public quickly started believing that beverages derived from nuts and seeds were nutritionally and ethically superior to cow’s milk, and thus a critical hit was taken by dairy farmers across the nation.41 iii. plant-based beverages are nutritionally inferior to milk perhaps the biggest difference between cow milk and its plant-based alternatives are their nutritional composition. many alternatives fall short of meeting the same needs that cow’s milk fulfills, especially in growing infants and children.42 the associated lack of information and education in this disparity can have detrimental effects on not only nutrition of the population, but also on overall health and food security.43 for instance, inadequate substitution of plant alternatives for cow’s milk in the diet can lead to major nutritional gaps for the entire population, but most importantly in children.44 consumers who lack knowledge of what they are choosing to incorporate in their diet puts them at risk of health consequences caused by under-consumption of key nutrients found in milk, such as calcium and vitamin d, both of which are essential for bone health and preventing bone fractures.45 dairy is one of the key food groups on any food pyramid, which traditionally includes fat-free and low-fat milk, yogurt, cheese, and even fortified soy beverages.46 the fda guidelines state that fortified47 soy is included because it 36. see id. 37. id. 38. id. 39. franklin-wallis, supra note 1. 40. id. 41. see verduci et al., supra note 28. 42. id. at 2. 43. id. 44. id. at 11. 45. press release, food & drug admin., supra note 7. 46. use of the names of dairy foods in the labeling of plant-based products, 83 fed. reg. 49,103, 49,107 (sept. 25, 2018). 47. see johanna dwyer et al., fortification and health: challenges and opportunities, 6 2022] dairy beloved 405 is the closest alternative to low-fat and non-fat milks, so long as it has been fortified with, at minimum, calcium, vitamin a, and vitamin d.48 other plantbased alternatives to milk are explicitly excluded from the dairy food group because their overall composition is not similar to milk. 49 the 2015-2020 dietary guidelines for americans also identified that americans as a whole are not meeting the recommended intake of milk and other dairy products.50 this led to the united states department of agriculture (“usda”) recommending an increased intake of low-fat and fat-free dairy foods in nutrient-dense forms, like milk, as a method of increasing calcium, vitamin d, and potassium levels.51 the reality is that adults in the united states have misinformed perceptions on the health status of milk, and how the alternatives they are using stack up against it.52 a study conducted by the national dairy council (“ndc”) found that the majority of adults surveyed incorrectly believed that almond, soy, and coconut alternatives to milk had the same, if not greater, levels of protein and other key nutrients that milk has.53 one of the major reasons that adults make the switch from cow’s milk to an alternative is for perceived health benefits.54 a closer look at the nutrient breakdown of milk and some of its most popular alternatives illustrates that many of the non-dairy choices are actually nutritionally inferior. a. cow’s milk growing up, children are told to drink their milk in order to make their teeth and bones nice and strong. cow’s milk has a long history of being consumed in many parts of the world, mostly for its ideal balance of three macronutrients necessary in a well-rounded diet: fats, carbohydrates, and proteins.55 in addition, the nutrients found in cow’s milk are associated with prevention of hypertension, cardiovascular disease, obesity, osteoporosis, and even cancer.56 b. plant-based milk alternatives the following is a brief overview of the most popular types of plant-based alternatives to milk: almond, soy, rice, coconut, and oat. advances in nutrition 124 (2015) (explaining the process of using fortification as a way of adding nutrients to foods and beverages). 48. use of the names of dairy foods in the labeling of plant-based products, 83 fed. reg. at 49,103, 49,107. 49. id. 50. id. 51. sipple, supra note 33. 52. see id. 53. id. 54. id. 55. see sai kranthi vanga & vijaya raghavan, how well do plant based alternatives fare nutritionally compared to cow’s milk?, 50 j. food sci. & tech. 10 (2018). 56. sipple, supra note 33. 406 indiana health law review [vol. 19:399 1. almond-based milk alternatives one of the most popular alternatives to milk is its almond-derived alternative.57 it was mainly introduced and marketed towards people seeking an alternative to milk due to an allergy or lactose intolerance.58 it is also seen as desirable for its cholesterol-lowering and potential prebiotic benefits.59 almond-based beverages are a colloidal dispersion that is made by mixing water with powdered or pasted almonds.60 the resulting liquid is homogenized using high pressures and then pasteurized to increase shelf stability.61 the homogenization and heat treatment processes that almond-based beverages go through can result in deviations of various properties of the liquid, including the nutrient profile.62 almonds have a high concentration of monounsaturated fatty acids (“mufas”) and polyunsaturated fatty acids (“pufas”), which are considered helpful in losing and maintaining weight.63 almonds are also high in protein, fiber, vitamin e (an antioxidant), and manganese, and generally rich in calcium, potassium, magnesium, iron, selenium, copper, and zinc.64 almond-based beverages hover around 35 calories per serving, each containing about 3 grams of carbohydrates and 5 grams of protein.65 median ranges of calcium, an essential nutrient in milk, fall right around 330 milligrams, mainly because of calcium being added post-processing.66 almond beverages also have notable amounts of fat-soluble vitamins e and a.67 almond-based beverages must be fortified with critical micronutrients like calcium and vitamin b-12 in order to meet the requirements of growing children.68 2. soy-based milk alternatives as early as the 14th century, people in china have been using soybeans to 57. see santosh dhakal et al., effect of high pressure processing on the immunoreactivity of almond milk, 62 food rsch. int’l 215 (2014). 58. vanga & raghavan, supra note 55, at 12. 59. see sarita singhal et al., a comparison of the nutritional value of cow’s milk and nondairy beverages, 64 j. pediatric gastroenterology & nutrition 799 (2017). 60. vanga & raghavan, supra note 55, at 12. 61. see neus bernat et al., development of a non-dairy probiotic fermented product based on almond milk and inulin, 21 food sci. & tech. int’l 440 (2014). 62. see neus bernat et al., effect of high pressure homogenization and heat treatment on physical properties and stability of almond and hazelnut milks, 62 lwt – food sci. & tech. 488 (2015). 63. vanga & raghavan, supra note 55, at 12. 64. verduci et al., supra note 28, at 12. 65. vanga & raghavan, supra note 55, at 13. 66. id. 67. id. 68. verduci et al., supra note 28, at 12. 2022] dairy beloved 407 produce a liquid, mostly as part of the tofu-making process.69 milk alternatives derived from soybeans were among the first to be developed as a way of providing nutrients to populations where milk supply was inadequate.70 soy-based beverages average about 95 calories per serving, with about 4 grams of carbohydrates, 8 grams of protein, and 4.5 grams of fat in each.71 soybeans are very rich in relatively high-quality protein, and have plenty of isoflavones, which are known for having properties that protect against cancer, cardiovascular disease, and osteoporosis.72 soy is also a good source of trans-fats, mufas, and pufas, and its high levels of phytosterols have cholesterollowering properties.73 one major drawback of anything derived from soy is the characteristic “beany” flavor that it has.74 another concern is the number of anti-nutritional factors present in soybeans, despite its handful of heart-protective qualities.75 it also does not avoid the allergy issue, as there are people with soy allergies as well.76 soy beverages also tend to have deficits in calcium and vitamin b-12 levels, so these micronutrients are often supplemented into the drink.77 3. rice-based milk alternatives rice-based beverages are made from mixing milled brown rice with water.78 rice is very rich in carbohydrates, and rice-based beverages are no different.79 the processing of the rice and water mixture leads to the breakdown of carbohydrates into sugars, leading to a characteristically sweet taste, but significant amounts of sugar that lead to malnutrition with regular consumption.80 69. franklin-wallis, supra note 1. 70. see verduci et al., supra note 28. 71. vanga & raghavan, supra note 55, at 14. 72. see bjarne jacobsen et al., does high soy milk intake reduce prostate cancer incidence? the adventist health study (united states), 9 cancer causes & control 553 (1998); see also adetayo omoni & rotimi aluko, soybean foods and their benefits: potential mechanisms of action, 63 nutrition rev. 272 (2005); verduci et al., supra note 28. 73. see verduci et al., supra note 28. 74. vanga & raghavan, supra note 55, at 14. 75. see brinda harish vagadia et al., effects of thermal and electric fields on soybean trypsin inhibitor protein: a molecular modelling study, 35 innovative food sci. & emerging tech. 9 (2016); see also shaohong yuan et al., elimination of trypsin inhibitor activity and beany flavor in soy milk by consecutive blanching and ultrahigh-temperature (uht) processing, 56 j. agric. & food chemistry 7957 (2008); verduci et al., supra note 28. 76. verduci et al., supra note 28, at 12. 77. id. at 11. 78. vanga & raghavan, supra note 55, at 15. 79. see id. 80. see kenneth katz et al., rice nightmare: kwashiorkor in 2 philadelphia-area infants fed rice dream beverage, 52 j. am. acad. dermatology s69 (2005); see also guy massa et al., protein malnutrition due to replacement of milk by rice drink, 160 eur. j. pediatrics 382 408 indiana health law review [vol. 19:399 when given to children, parents generally are not aware of the fundamental differences in nutrition between rice beverages and cow’s milk.81 kwashiorkor, a form of protein-energy malnutrition, was observed in infants that were on a rice-based diet, illustrating the risk of malnutrition in consuming solely rice-based beverages.82 high levels of arsenic have also been reported in rice, and thus its derivatives, which can be extremely dangerous to humans, even causing cancer in some cases.83 traces of calcium, magnesium, iron, and vitamins a and e are present in ricebased beverages but would still need to be fortified to increase many micronutrient levels.84 they generally go unfortified though, and thus lack crucial minerals and vitamins like adequate levels of calcium and vitamin b-12.85 rice beverages average about 26 grams of carbohydrates per serving, while the protein and fat content is almost non-existent.86 4. coconut-based milk alternatives coconut is a staple in certain cultural cuisines, especially in southeast asia, and is used for both cooking and drinking, and the liquid component is produced from grating the white meat of the coconut.87 various research studies have found conclusive evidence that consumption of coconut can increase high-density lipoprotein (“hdl”) levels, which help in reducing the harmful low-density lipoprotein (“ldl”) levels.88 this is because coconut contains lauric acid, which raises levels of hdl cholesterol, which in turn helps lower ldl cholesterol levels in the blood stream.89 in terms of benefits, coconut is also rich in potassium, magnesium, iron, and zinc, as well as moderate values of vitamins e (2001). 81. verduci et al., supra note 28, at 12. 82. vanga & raghavan, supra note 55, at 15. 83. see iva hojsak et al., arsenic in rice: a cause for concern, 60 j. pediatric gastroenterology & nutrition 142 (2015). 84. verduci et al., supra note 28, at 12. 85. see winston craig, health effects of vegan diets, 89 am. j. clinical nutrition 1627s (2009); see also virginia messina & ann reed mangels, considerations in planning vegan diets: children, j. am. dietetic ass’n 661 (2001). 86. vanga & raghavan, supra note 55, at 16. 87. see swati sethi et al., plant-based milk alternatives an emerging segment of functional beverages: a review, 53 j. food sci. & tech. 3408 (2016). 88. see ruvan ekanayak et al., impact of a traditional dietary supplement with coconut milk and soya milk on the lipid profile in normal free living subjects, 2013 j. nutrition & metabolism 1 (2013); see also ronald mensink et al., effects of dietary fatty acids and carbohydrates on the ratio of serum total to hdl cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials, 77 am. j. clinical nutrition 1146 (2003). 89. see ekanayak et al., supra note 88. 2022] dairy beloved 409 and c.90 long-term storage of coconut-based beverages can be a challenge, as most varieties come in a can.91 part of the canning process requires a thermal treatment to ensure that it is shelf-stable for a certain period of time.92 this treatment process causes the concentration of short and medium chain fatty acids and aldehydes to increase over time due to lipid oxidation.93 that basically means that the longer the coconut-based beverage is stored, the lower the nutritional value becomes.94 coconut-based beverages tend to hover around 45 calories per serving, however the majority of these calories come from saturated fats, which are often associated with cardiovascular issues.95 it also contains almost no protein and negligible amounts of carbohydrates, especially in comparison to its high saturated fat content.96 5. oat-based milk alternatives one of the newest, and perhaps trendiest, alternatives to milk as of late comes from oats.97 oat drinks have low amounts of fat and protein, but a varied amino acid profile.98 fiber and phytochemicals, like antioxidants and polyphenols, contribute to the relatively high nutritional value.99 the soluble fiber in oats give it the ability to increase solution viscosity, which delays gastric emptying time.100 this increases gastrointestinal transit time, and thus reduces blood glucose levels and ldl cholesterol in the bloodstream.101 however, oats contain significant levels of phytic acid, an antinutrient that interferes with the uptake of certain other nutrients.102 it also lacks calcium, which requires oat-based beverages to be fortified in order to even attempt to rival the nutritional composition of milk.103 90. verduci et al., supra note 28, at 12. 91. see patcharaporn tinchan et al., changes in the profile of volatiles of canned coconut milk during storage, 80 j. food sci. c49 (2014). 92. id. 93. id. 94. id. 95. vanga & raghavan, supra note 55, at 17. 96. id. 97. see, e.g., wow no cow, oatly (2021), https://us.oatly.com/pages/oatly-tv#https://cdn. shopify.com/s/files/1/0248/3883/2225/files/wnc-sb-cut.mp4 [https://perma.cc/zv28-22n6]. this commercial was originally aired during the 2021 super bowl. id. 98. verduci et al., supra note 28, at 13. 99. id. 100. see sethi et al., supra note 87. 101. id. 102. verduci et al., supra note 28, at 13. 103. id. 410 indiana health law review [vol. 19:399 c. why the differences in nutrition are significant the major issue of labeling plant-based beverages as “milk” is not necessarily that consumers are unaware or confused as to where their drink came from.104 the issue lies in the connotations that the word “milk” has, especially when it comes to nutrition.105 many consumers can look at a label reading “almond milk” and realize that the liquid in the carton is derived from almonds.106 significantly fewer consumers can look at the same label and recognize that the nutrient content of the liquid in the carton is different than what they would be getting from cow’s milk.107 this general lack of information regarding the nutritional differences between milk and its alternatives is why labeling is so important.108 more specific labeling can help consumers realize that plant-based beverages are not a one-toone substitute for milk.109 according to a study published by the national dairy council, 53% of exclusive dairy milk buyers cite nutrition as important to their purchase decision; 62% of exclusive plant-based milk buyers cite it as necessary.110 exclusive dairy milk buyers associate nutrition and health overwhelmingly with dairy milk.111 in contrast, exclusive plant-based milk buyers perceive plant-based milk as significantly stronger linked to nutrition, health, vitamins, minerals, and protein.112 the majority of consumers perceive almond, soy, and coconut milk as having the same or more protein and key nutrients as dairy milk.113 the top reason consumers believe plant-based milk is labeled as “milk” is because the products are comparable on a nutrition front, with more than half citing this as a reason.114 current regulations provide that a product will not be considered an imitation so long as it is not nutritionally inferior and bears an appropriately descriptive 104. umair irfan,“fake milk”: why the dairy industry is boiling over plant-based milks, vox (dec. 21, 2018, 3:25 pm), https://www.vox.com/2018/8/31/17760738/almond-milk-dairy-soyoat-labeling-fda [https://perma.cc/u5am-h6sf]. 105. see sam sabin, got milk? for 46% of u.s. adults in poll, only if it’s from an animal, morning consult (july 25, 2018, 12:01 am), https://morningconsult.com/2018/07/25/got-milkfor-46-us-adults-poll-only-from-animal/ [https://perma.cc/2sd3-be2m]. 106. see irfan, supra note 104. 107. id. 108. id. 109. id. 110. consumer perceptions: dairy milk and plant-based milk alternatives, nat’l dairy council (oct. 29, 2018, 7:17 pm), https://www.usdairy.com/getmedia/1d205edf-d76e-4440-a47d5 f e 8 5 7 6 4 4 ccc /da iry%2 0 an d%2 0 plan t%2 0 on e-page% 2 0 su m m a r y% 2 0 1 0 -2 8 2018%20final.pdf.pdf.aspx [https://perma.cc/le8h-9d65]. 111. id. 112. id. 113. id. 114. id. 2022] dairy beloved 411 common or usual name.115 therefore, plant-based milk alternatives need to contain the same levels of protein, vitamin d, vitamin a, and all other nutrients present in cow’s milk at a level of two percent or more.116 otherwise, the alternatives are subject to being considered a milk imitation.117 1. balance of macronutrients in order to act as an adequate alternative to milk, a beverage should have a similar distribution of carbohydrates, fats, protein, and similar calorie content as milk.118 a serving of milk is about 64 calories and about 3 to 4.5 grams each of carbohydrates, fats, and protein.119 milk is the most balanced option, whereas almond, rice, and coconut alternatives do not come close to being an adequate replacement in this respect.120 almonds and coconuts get most of their energy composition from fat, and rice gets it almost completely from carbohydrates.121 coconuts are also extremely high in saturated fats, commonly associated with cardiovascular disease.122 rice is a very poor source of protein and fat, as starch makes up almost all of it.123 almonds and soybeans have high concentrations of mufas and pufas, especially in comparison to their saturated fat content.124 both mufas and pufas also lead to a reduced risk of cardiovascular issues and cancer formation.125 the health benefits, together with the relative balance of energy, make almond and soy alternatives to milk the two best options in terms of the three macronutrients. 2, calcium beyond energy content, milk is an important source of calcium, which is 115. sam danley, ift20: plant-based labeling debate continues, food bus. news (july 20, 2020, 7:57 pm), https://www.foodbusinessnews.net/articles/16451-ift20-plant-based-labelingdebate-continues [https://perma.cc/47ze-8yyz]. 116. id. 117. id. 118. vanga & raghavan, supra note 55, at 18. 119. id. at 17. 120. id. at 18. 121. id. 122. see patty siri-tarino et al., meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease, 91 am. j. clinical nutrition 535, 535 (2010). 123. vanga & raghavan, supra note 55, at 18. 124. id. 125. see penny kris-etherton, monounsaturated fatty acids and risk of cardiovascular disease, 100 circulation 1253 (1999); see also haim tapiero et al., polunsaturated fatty acids (pufa) and eicosanoids in human health and pathologies, 56 biomedicine & pharmacotherapy 215 (2002). 412 indiana health law review [vol. 19:399 required by the human body to maintain bone health throughout life, as well as bone formation and development during childhood and adolescence.126 at face value, it may appear that almond and soy alternatives have greater calcium content than milk.127 however, the correct way to analyze amounts of calcium is by the weight of the nutrient per calorie, commonly known as nutrient density.128 when this is taken into consideration, milk offers 1.9 milligrams calcium per calorie, which is much higher than almonds (0.46 milligrams calcium per calorie) and soybeans (0.62 milligrams calcium per calorie).129 calcium is often added to most varieties of plant-based beverages to directly mimic the calcium levels in cow’s milk, with the levels varying widely.130 while it is true that most alternatives to milk are fortified with calcium, the bioavailability of that calcium differs depending on the form it is present in.131 for instance, calcium in cow’s milk is “colloidal as caseinate-phosphate complex and is readily released during digestion.”132 calcium in fortified beverages are often in the form of calcium carbonate and tricalcium phosphate, which have varying levels of availability for absorption when compared with calcium in cow’s milk.133 3. carbohydrates the significantly lower number of calories present in plant-based alternatives to milk is one of the driving forces behind their increase in demand.134 the main reason for the higher number of calories in cow’s milk is the sugar content, which is generally lower among plant alternatives, with the exception of rice-based products.135 coconut tends to have the lowest number of carbohydrates, followed by almond, soy, then cow’s milk, and with rice coming out at the highest.136 interestingly, the different plant-based beverages have different effects on the glycemic index based on their carbohydrate content.137 rice and coconut drinks 126. see shanthy bowman, beverage choices of young females: changes and impact on nutrient intakes, 102 j. acad. nutrition & dietetics 1234 (2002); see also rivka black sandler et al., postmenopausal bone density and milk consumption in childhood and adolescence, 42 am. j. clinical nutrition 270 (1985). 127. vanga & raghavan, supra note 55, at 18. 128. see harold newmark, nutrient density: an important and useful tool for laboratory animal studies, 8 carcinogenesis 871 (1987). 129. vanga & raghavan, supra note 55, at 18. 130. id. 131. see sipple, supra note 33. 132. id. 133. id. 134. vanga & raghavan, supra note 55, at 18. 135. id. 136. id. 137. see stephanie jeske et al., evaluation of physicochemical and glycaemic properties of commercial plant-based milk substitutes, 72 plant foods hum. nutrition 26 (2017). 2022] dairy beloved 413 have the highest levels due to high glucose contents.138 oat drinks were next due to beta-glucans, followed by relatively low levels for soy and almond drink.139 milk would likely fall higher on the glycemic index because it contains the sugars lactose and galactose.140 4. cholesterol and fats one downfall that milk has is cholesterol.141 since it comes from an animal, milk naturally has cholesterol.142 plant-based beverages do not have any cholesterol, which is one advantage that they do have over milk, and thus is another reason for their increased demand.143 milk also has the highest fat content, with about two-thirds coming from saturated fat, and the other third coming from mufas.144 saturated fat is the lowest in almond beverages, followed by rice, soy, and finally coconut, with almost all of its fat coming from saturated fats.145 almond-based beverages have no saturated fats and high quantities of unsaturated fatty acids, making them seem like a better alternative than the other plant-based beverages on this criterion.146 5. protein one of the most significant nutrients coming from milk is protein.147 soybased beverages are the only alternative that comes close to comparing, with almost the same protein levels being provided.148 almond beverages also provide a small amount of protein, but not enough to be comparable to milk.149 beverages made from quinoa, hemp, and oats are notable for having greater than 1% of energy from protein, but overall those values are not impressive.150 another issue with proteins coming from plant sources is that they are generally of lower nutritional quality than animal-derived counterparts.151 this is because plant proteins have a limited range of amino acids, such as lysine in 138. id. 139. id. 140. verduci et al., supra note 28, at 13. 141. see vanga & raghavan, supra note 55, at 18. 142. see robert jensen et al., the composition of milk fat, 74 j. dairy sci. 3228 (1991). 143. vanga & raghavan, supra note 55, at 18. 144. id. 145. id. 146. id. 147. id. 148. id. 149. id. 150. verduci et al., supra note 28, at 13. 151. see outi elina makinen et al., foods for special dietary needs: non-dairy plant-based milk substitutes and fermented dairy-type products, 56 critical rev. food sci. & nutrition 339 (2016). 414 indiana health law review [vol. 19:399 cereal grains and methionine in legumes.152 amino acids, which are the “building blocks” of proteins, are fragmented in plant-based products, meaning that they do not make up complete proteins.153 when proteins are fragmented, the nutritional value is greatly diminished because the protein is harder for humans to digest.154 cow’s milk is commonly used as a way to get readily available protein in the diet of many americans.155 this poses a problem when cow’s milk is replaced with one of its plant alternatives.156 even if a plant-based alternative is fortified with protein, the protein is of a lesser quality, and there is no way of differentiating that on a nutrition label.157 to the average consumer, protein appears to be the same whether it comes from a fortified plant drink or from cow’s milk, even though that is not an accurate assumption.158 an argument against milk being a major source for protein in the human diet is that the proteins present in milk can sometimes trigger allergic reactions to milk and other dairy products.159 while there is no way around this, it is also worth noting that allergies to proteins in soybeans is also common, as well as almond proteins.160 it is unlikely that the same person is allergic to all three proteins, but this illustrates that no one beverage is immune from causing allergic reactions.161 6. micronutrients and fortification minerals present in cow’s milk in significant quantities includes magnesium, phosphorous, and potassium.162 most of the milk alternatives contain comparable amounts of these minerals, with the exception that coconut-based beverages have no phosphorous, and both coconut and rice beverages have low levels of potassium.163 since plant-based beverages are considerably lower in protein, vitamins b-12, b-2, d, and e also tend to be low.164 this is why many plant-derived drinks are fortified with various vitamins and minerals that are commonly found in milk.165 152. id. 153. danley, supra note 115. 154. see makinen et al., supra note 151. 155. see danley, supra note 115. 156. id. 157. id. 158. id. 159. see scott sicherer, epidemiology of food allergy, 127 j. allergy& clinical immunology 594 (2011); see also sai kranthi vanga et al., review of conventional and novel food processing methods on food allergens, 57 critical rev. food sci. & nutrition 2077 (2015). 160. see sicherer, supra note 159; vanga et. al., supra note 159. 161. vanga & raghavan, supra note 55, at 18. 162. id. 163. id. 164. verduci et al., supra note 28, at 13. 165. id. 2022] dairy beloved 415 soy beverages are the only alternative that has somewhat similar levels of vitamins.166 the vitamin content of other milks is not reported on their labels, which means that the vitamins are either not present, or are present in such small quantities that they are not able to be labeled.167 even when beverages are fortified with vitamins and minerals, the nutritional properties still differ quite considerably because nutrient bioavailability can depend on a wide range of factors, including the fortification process.168 the vast differences in nutritional value between milk and its alternatives illustrates the need for education on the composition of what consumers are purchasing and providing to their families. many milk alternatives also rely heavily on the fortification process to add in key nutrients they naturally lack.169 while this may seem like a good solution to the nutritional disparity issue, fortified nutrients may not be as bioavailable as naturally occurring nutrients, which means that they may not be absorbed at a full capacity in order for the body to use.170 if the body is not getting these nutrients, it further contributes to the high risk of malnutrition when an individual relies solely on milk alternatives.171 combined with a lack of knowledge on how to better supplement and make up for this lost nutrition, many people may not be getting the appropriate amount of vitamins and minerals required on a daily basis for a healthy lifestyle.172 7. children a key demographic of milk drinkers is children.173 if children are consistently drinking plant-based beverages in place of milk, they are not getting the appropriate nutrients they need to grow and develop at an appropriate rate.174 regular consumption of cow’s milk has been associated with increased height in children, which is a factor taken into consideration when evaluating a child’s nutritional status.175 regular consumption of plant-based beverages is generally associated with a lower childhood height, most likely attributable to a lower protein intake, since the quality of protein provided by plants is lower than that of mammals.176 another protein-related malnutrition disorder in children is kwashiorkor, which can be life threatening, although is not commonly seen in 166. vanga & raghavan, supra note 55, at 19. 167. id. 168. see sarita singhal et al., a comparison of the nutritional value of cow’s milk and nondairy beverages, 64 j. pediatric gastroenterology & nutrition 799 (2017). 169. verduci et al., supra note 28, at 13. 170. see singhal et al., supra note 59. 171. see makinen et al., supra note 151. 172. id. 173. id. 174. id. 175. sipple, supra note 33. 176. id. 416 indiana health law review [vol. 19:399 developed countries, like the united states.177 however, cases have been reported in the united states in children who consume only plant-based beverages, most likely due to either lactose allergies, or simply lack of parent or guardian education on the nutritional importance of dairy products.178 8. the “best” plant-based alternative after analyzing the key nutrients in milk, and how the plant-based beverages compare, soy beverages come the closest nutritionally to comparing to cow’s milk.179 however, the distinctive “beany” flavor of soy products, as well as the anti-nutrients present in soybeans are two major downfalls that may prompt consumers to turn towards almond beverages.180 almonds provide a fairly balanced nutrient profile and have a much more neutral flavor.181 their nutrient density and overall number of calories are not as rich as cow’s milk, which creates the need to be extra careful to consume all of the essential nutrients if almond beverages are used to replace cow’s milk in the human diet.182 rice and coconut derived beverages cannot be used as a nutritional equivalent to cow’s milk in the diet.183 both have limited nutrient diversity, are too concentrated in either carbohydrates or fats, and have almost no protein content.184 d. health benefits of cow’s milk milk and other dairy products are good sources of high-quality protein, which is important in weight loss and maintenance.185 high-quality protein has a satiating effect which helps prevent over-consumption of calories and reduces body fat stores.186 protein from dairy is also a good source of essential amino acids for muscle protein synthesis which maintains the metabolically active 177. id. 178. id. 179. vanga & raghavan, supra note 55, at 19. 180. id. 181. id. 182. id. 183. id. 184. id. at 18. 185. tanja kongerslev thorning et al., milk and dairy products: good or bad for human health? an assessment of the totality of scientific evidence, 60 food & nutrition rsch. 1, 2 (2016). 186. see jo-anne gilbert et al., effect of proteins from different sources on body composition, 21 nutrition, metabolism & cardiovascular diseases b16 (2011); see also line bendtsen et al., effect of dairy proteins on appetite, energy expenditure, body weight, and composition: a review of the evidence from controlled clinical trials, 4 advances nutrition 418 (2013). 2022] dairy beloved 417 muscle mass during weight loss.187 dairy can facilitate weight loss and improve body composition by reducing body fat mass and preserving lean body mass.188 “low-fat, calcium-rich dairy products are generally considered to lower blood pressure.”189 there are also studies that show an inverse relationship between milk intake and both the chances of stroke and cardiovascular disease.190 milk contains a number of nutrients that are required for building and maintaining strong bones and reducing osteoporosis and bone fractures in older age.191 protein, calcium, phosphorous, magnesium, manganese, zinc, vitamin d, and vitamin k are all necessary for maintaining healthy bones.192 these vitamins and minerals, with the exception of vitamin d, are all naturally present in significant amounts in milk, and most milks are fortified with vitamin d.193 the 2015-2020 dietary guidelines for americans note the importance of calcium in building and protecting bones, mentioning that plant-based beverages typically contain inorganic chemical forms of calcium, which may increase cardiovascular risk and do little in the way of supporting bone health.194 although studies are inconsistent, consumption of milk probably helps protect against colorectal cancer, bladder cancer, gastric cancer, and breast cancer.195 these findings are quite robust in the area of milk consumption preventing colorectal cancer in women.196 despite most of the plant-based beverages having lower saturated fat and cholesterol levels than cow’s milk, some have higher caloric content due to high contents of oils or added sugars that envy those of sugar-sweetened juices and sodas.197 such high levels of added sugar are linked to obesity, reduced insulin sensitivity, increased liver, muscle, and visceral fat content, increased blood pressure, and increased concentrations of triglycerides and cholesterol in the blood.198 overall, there is insufficient evidence to conclude that plant-based 187. see arne astrup et al., the role of higher protein diets in weight control and obesityrelated comorbidities, 39 int’l j. obesity 721 (2014). 188. see mu chen et al., effects of dairy intake on body weight and fat: a meta-analysis of randomized controlled trials, 96 am. j. clinical nutrition 735 (2012). 189. thorning et al., supra note 185, at 2. 190. id. at 3. 191. see rene rizzoli, dairy products, yogurts, and bone health, 99 am. j. clinical nutrition 1256s (2014). 192. thorning et al., supra note 185, at 3. 193. id. 194. id. at 4. 195. id. at 5. 196. id. 197. see marianne jakobsen et al., intake of carbohydrates compared with intake of saturated fatty acids and risk of myocardial infarction: importance of the glycemic index, 91 am. j. clinical nutrition 1764 (2010). 198. see maria maersk et al., sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-month randomized intervention study, 95 am. j. clinical nutrition 283 (2011). 418 indiana health law review [vol. 19:399 drinks have superior health benefits to those of milk.199 as such, it is again important to be cautious when substituting any beverage for milk for the general population.200 iv. truth in labeling legislation a. state legislation in the 2019 legislative session, representative terry goodin proposed the indiana truth in labeling act. this act sought to amend the current laws regarding dairy products to prohibit the sale of drinks if the product does not consist of milk from a cow, goat, or other mammal, and the label implies that the product is a dairy product.201 after the act was heard, it was referred to the committee on agriculture and rural development; however, it did not progress from there.202 indiana is one of numerous states that has considered recent legislation regarding the issue of whether plant-based beverages can be labeled “milk.”203 some attempts at legislation have been more successful than others, but the common idea behind the recent efforts is clear.204 officials across the united states are aware that the labeling of plant-based beverages is raising red flags and are looking for ways to do something about it.205 in 2018, north carolina passed a farm bill, stating that plant-based products with the word “milk” on its packaging are mislabeled.206 this bill also prohibited the sale of these plant-based “milks.”207 in order to comply with commerce regulations, the large caveat for this bill required at least eleven of a selection of fourteen southern states to enact similar legislation.208 so far, getting eleven of the named states to follow north carolina’s lead has been largely ineffective. maryland, one of the states mentioned in north carolina’s bill, did pass the fair milk labeling bill in 2019.209 this bill prohibits a person from selling or advertising a product labeled as “milk” or a milk-based product unless it is derived from a cow or other animal.210 it essentially mirrored all the requirements 199. see thorning et al., supra note 185. 200. id. 201. h.b. 1350, 121st gen. assemb., 2nd reg. sess. (ind. 2020). 202. id. 203. see sabin, supra note 105. 204. id. 205. id. 206. s.b. 711, 2017 gen. assemb., reg. sess. (n.c. 2018). 207. id. 208. id. (naming the following states in north carolina’s farm bill: alabama, arkansas, florida, georgia, kentucky, louisiana, maryland, mississippi, oklahoma, south carolina, tennessee, texas, virginia, and west virginia). 209. s.b. 922, 2019 gen. assemb., reg. sess. (md. 2019). 210. id. 2022] dairy beloved 419 set out in the north carolina farm bill and listed the same provision of eleven out of the same fourteen states needing to enact something similar in order for the bill to be enforceable.211 north carolina and maryland illustrate the two most successful attempts in the united states in terms of passing legislation imposing more strict definitions and regulations on what can and cannot be labeled as “milk.” louisiana also passed their senate bill 39, which specifically targeted milk labeling of products other than ones that come from cows, goats, or other hooved mammals, effective on august 1, 2019.212 other states have attempted to pass similar bills in recent years as well, although most of those efforts have been unsuccessful. among these attempts include kentucky senate bill 81,213 new york assembly bill a8144a,214 oklahoma house bill 2994,215 west virginia senate bill 320,216 and nebraska legislative resolution 13.217 virginia’s hb 119 was passed by both the house and senate of virginia, but was ultimately vetoed by the governor and sustained by the house.218 wisconsin’s assembly bill 516 also attempted to put in place a statute that would be similar to the ones in north carolina and maryland.219 b. the dairy pride act in december 2016, members of congress collectively requested the fda to take a stand against the mislabeling of products imitating milk.220 they argued that allowing the term “milk” on products that did not contain milk from a cow was “misleading to consumers, harmful to the dairy industry and a violation of milk’s standard of identity.”221 then came the defending against imitations and replacements of yogurt, milk, and cheese to promote regular intake of dairy everyday act, or the dairy pride act, which was first introduced by wisconsin senator tammy baldwin in january 2017.222 a second push for the same act was made again in 2019, this time cosponsored by senator baldwin and idaho senator jim risch.223 211. id. 212. s.b. 39, 2019 reg. sess. (la. 2019). 213. s.b. 81, 2020 gen. assemb., reg. sess. (ky. 2020). 214. s.b. a8144--a, 2019-2020 gen. assemb. reg. sess. (n.y. 2019). 215. h.b. 2994, 57th leg., 2nd sess. (okla. 2020). 216. s.b. 320, 2020 gen. assemb., reg. sess. (w. va. 2020). 217. s. res. 13, 106th leg., 1st sess. (neb. 2019). 218. h.b. 119, 2020 gen. assemb., reg. sess. (va. 2020). 219. h.b. 516, 2019 gen. assemb., reg. sess. (wis. 2019). 220. leone, supra note 5, at 440. 221. id. 222. sipple, supra note 33. 223. press release, sen. tammy baldwin, baldwin, risch lead bipartisan effort to stand up for america’s dairy farmers (jan. 23, 2020), https://www.baldwin.senate.gov/press-releases/ baldwin-risch-standing-up-for-dairy-farmers [https://perma.cc/c537-mlaj]. 420 indiana health law review [vol. 19:399 the main goal of the dairy pride act was to prevent products with plantbased ingredients from being mislabeled as “milk,” “yogurt,” or “cheese.”224 the driving reason for this nationwide legislation was that, although the fda defines milk as coming from mammals, they have not enforced labeling regulations consistent with these definitions.225 in turn, this hurts dairy farmers across the united states that are working to ensure that the milk and other dairy products they are producing are meeting fda standards and are nutritious, all while their plant-based counterparts are getting by due to lax enforcement of federal guidelines.226 the spread of these mislabeled plant-based products is only increasing, all of which contain varying ingredients and nutrient levels and are not equivalent to that from dairy milk.227 in further support of the dairy pride act, senators baldwin and risch penned a bipartisan letter on behalf of dairy farmers to dr. stephen hahn, the commissioner of the fda.228 the letter emphasized the hard work that dairy farmers put into ensuring the milk they are producing is healthy, nutrient-dense, and otherwise complies with regulations set forth by the fda, as well as stressing how consumers often assume that plant-based alternatives are provided with the same level of care.229 the letter proposed a call to action to commissioner hahn, referencing the comment period that was initiated by former commissioner gottlieb to review regulations on dairy labeling, and encouraged commissioner hahn to address the issue for the sake of fairness to dairy farmers across america.230 c. why indiana should adopt truth in labeling legislation the fda already has a standard of identity set for milk labeling.231 enactment of the dairy pride act would require the fda to issue guidance for nationwide enforcement of mislabeled plant-based products, as well as keep the fda accountable for enforcing milk’s standard of identity.232 the recent upswing in proposed legislation seeking to regulate plant-based product labeling sends a message to the fda that this is a topic that consumers 224. id. 225. id. 226. id. 227. see supra, section iii. 228. press release, sen. tammy baldwin, supra note 223. 229. id. 230. id. the covid-19 pandemic put these efforts on hold for the time being, but chances are that there will continue to be a push for fair labeling on a national level for years to come, especially as the popularity of milk alternatives is projected to continuously rise. 231. see 21 c.f.r. § 101.3 (2021). 232. beth newhart, us dairy groups press congress on dairy pride act, dairyreporter (feb. 6, 2020), https://www.dairyreporter.com/article/2020/02/06/us-dairy-groups-presscongress-on-dairy-pride-act [https://perma.cc/l62z-jczl]. 2022] dairy beloved 421 and their representatives care about and that they want to see changes made.233 even though many of the states’ proposed bills never made it out of committee discussions, the push for a change in labeling is more prevalent than it has ever been.234 the variance between states’ legislation efforts also signals to the fda that they need to lead the nation in regulation of plant-based labeling.235 since the success stories from north carolina and maryland rely heavily on similar bills being passed in other states so as not to negatively impact commerce, a more uniform approach led by the fda is likely the way for any real change to be made.236 efforts taken by individual states are still important. the introduction of indiana’s truth in labeling act in 2019 was just the beginning of the important conversations that need to be had surrounding milk alternatives.237 the more states that discuss bills like this year after year, the greater the awareness will be about the need for change.238 one state alone cannot change the entire nation, but each state that takes a step in the right direction puts the nation that much closer to making a change.239 v. recommendations a. following canada and europe’s lead the united states is not the only place where labeling of dairy products and their alternatives has been a hot button issue recently. for instance, a vegan “cheese” shop in vancouver, canada was recently prohibited by the canadian food inspection agency from using the word “cheese” in marketing and labelling its products.240 similar to milk, cheese is seen as a common name in canada, and is defined by the fact that it must be made from milk and its byproducts, as milk is understood under the common definition of the word.241 as a result of this, the shop could face a fraudulent labelling charge, as well as fines under canada’s 233. john breslin, in north carolina, plant-based milk isn’t milk, but only if other southern states agree, forbes (june 18, 2018), https://www.forbes.com/sites/legalnewsline/2018/06/18/inn or th -ca ro lin a -p lan t -based-m ilk-isn t -milk-bu t-on ly-if -o th e r -sou th e rn -s t a t es agree/?sh=280ecc346639 [https://perma.cc/3w54-ftzx]. 234. see id. 235. id. 236. id. 237. id. 238. id. 239. id. 240. alexandria gill, vegan food producer ordered to drop the word ‘cheese’ from its marketing, globe & mail (feb. 20, 2019), https://www.theglobeandmail.com/business/smallbusiness/marketing/article-vegan-food-producer-ordered-to-drop-the-word-cheese-from-its/ [https://perma.cc/9y7f-845s]. 241. id. 422 indiana health law review [vol. 19:399 food and drug regulations act section 5(2).242 “milk” is defined in canada as “the lacteal secretion, free from colostrum, obtained from the mammary gland of an animal.”243 this is almost identical to the definition of “milk” in the united states’ fda regulations.244 since the term “milk” cannot be used for nondairy products, many brands instead opt to call plant-based alternatives something along the lines of “almond beverage.”245 european countries have also passed rather strict regulations on what words non-dairy products are able to use on their labels. for instance, a 2017 lawsuit coming out of germany was a pivotal decision in milk labeling in europe. in verband sozialer wettbewerb ev v. tofutown.com gmbh, the european court of justice ruled that tofu-town, a german company, could not call its plantbased products names like “soyatoo tofubutter,” “plant cheese,” “veggie cheese,” or “cream.”246 this case also confirmed that the term “milk” was reserved only for products containing actual milk from mammals.247 this decision resulted in the european dairy association releasing guidelines to address the protected definitions and designations of milk and its derived products in the european single market, and also sought to enforce such regulations on a national level.248 another closely related case to the tofu-town decision stems out of the dutch court of appeals, involving a company called alpro, as well as the dutch dairy organization.249 this decision determined, among other things, that stating “alternative to yogurt” or “alternative to cream” on packaging is allowed.250 however, the use of the word “custard” was deemed illegal because it is a reserved name for a dairy product, and alpro was not using it on a product with dairy in it.251 the court also emphasized the importance of being careful not to mislead consumers in an advertisement and being sure to clearly designate when a product is derived from a source like soy.252 the european parliament voted on proposed amendments to the common agricultural policy (cap) in october 2020, further restricting dairy alternative 242. id. 243. definitions, gov’t can. (apr. 24, 2020), https://www.inspection.gc.ca/food-labelrequirements/labelling/industry/dairy-products/eng/1393082289862/1393082368941? chap=16#s22c16 [https://perma.cc/u973-lxax]. 244. see 21 c.f.r. § 131.110 (2021). 245. sabin, supra note 105. 246. see case c-422/16, verband sozialer wettbewerb ev v. tofu-town.com gmbh, european court of justice, seventh chamber (june 14, 2017), not yet published (eu). 247. leone, supra note 5, at 437. 248. id. 249. sarah arayess & fleur jeukens, alpro’s dairy alternatives: what is allowed and what is not in the light of ecj’s tofutown?, 13 eur. food & feed l. rev. 55, 55-56 (2018). 250. id. 251. id. 252. id. 2022] dairy beloved 423 labeling.253 words like “cheese,” “yogurt,” and “milk” are already banned on plant-based dairy alternatives in the eu.254 the vote prevents descriptors of “yogurt-style” or “cheese-alternative” to be put on non-dairy products.255 these new restrictions will force eu producers to carefully think about how they label their new and existing products, taking care to avoid all descriptors that would liken a plant-based product to its dairy counterpart.256 b. recommendations of solutions indiana could make about half of all americans surveyed in a 2019 study believed that plantbased beverages should not be allowed to use “milk” on their labels when told of the nutritional differences.257 this number jumped to 61% when the participants were informed that the fda specifically defines “milk” as an animal product.258 perhaps the most challenging question to answer is if not “milk,” what can these products be called? of course, there is no one perfect answer to this question, however something needs to be done to distinguish that what is known as “almond milk” or “soy milk” are not the same, especially from a nutrition perspective, as cow’s milk. most importantly, a product’s packaging needs to clearly designate that it is a plant-based alternative to milk. perhaps following canada’s lead and promoting something along the lines of “almond drink” or “almond beverage” is most appropriate.259 in both 2008 and 2012, the fda issued warning letters to two companies stating that the term “soy milk” was not an appropriate common name for a product that does not contain milk as it is legally recognized.260 in the alternative, the fda suggested calling it “soy drink” or “soy beverage,” both of which they would recognize as an acceptable common name.261 the words “beverage” and “drink” convey the purpose of the liquid in the package, all while staying away from misrepresentation or misbranding. another possible option is that, under the main designation of what the product is, it could be suitable to state something like “a plant-based alternative to milk.” this would be a more moderate approach than the eu has taken,262 as it allows the word “milk” to be on the packaging as long as it is clear that it is an 253. ciara cullen & sophie tuson, european parliament votes on plant-based food labels, reynolds porter chamberlain llp (nov. 25, 2020), https://www.rpc.co.uk/perspectives/foodand-drink/european-parliament-votes-on-plant-based-food-labels/ [https://perma.cc/at3e-majl]. 254. id. 255. id. 256. see id. 257. “milk” product labeling in the u.s., ipsos (jan. 10, 2019), https://www.ipsos.com/enus/news-polls/milk-product-labeling [https://perma.cc/c7n3-hu46]. 258. id. 259. see sabin, supra note 105. 260. leone, supra note 5, at 440. 261. id. 262. see cullen & tuson, supra note 253. 424 indiana health law review [vol. 19:399 alternative. rather than referencing milk at all, a suggestion of the beverages’ uses could be made on the packaging. for instance, a blurb that says, “tastes great in smoothies!” or “try pairing with cereal!” that way, the idea of what the product is gets across through some strategic packaging and marketing, without even needing to reference its potential similarities to milk. yet another possible solution would be to include the words “dairy-free” on the label. this would be most effective when paired with the designation of “beverage” or “drink” or even “milk alternative.” this gets at the idea that the plant-based beverage is not milk, is not related to or claiming to be similar to milk, and is not nutritionally similar to milk. if a producer cannot part with the idea of “milk” being on a plant-based label, the qualifier of “nutritionally inferior” could be used. this is likely a less desirable solution to the problem, as it probably is not the best strategy on a producer’s part to admit that their product is outright “inferior.” a “nutritionally inferior” label is the most truthful statement that could be made when comparing plant-based beverages to cow’s milk, and it has the added benefit of taking out a lot of the guess work for the consumer reading the label. along these same lines, indiana could follow florida’s lead, and specifically codify the definition of “imitation milk.”263 florida defines “imitation milk” as “those foods that have the physical characteristics, such as taste, flavor, body, texture, or appearance, of milk or milk products [. . .] but do not come within the definition of ‘milk’ or ‘milk products’ and are nutritional inferior to the product imitated.”264 designating a product as imitation milk allows the word “milk” to still appear on labels, and the word “imitation” more clearly identifies that there are clear differences between milk and the product in question.265 finally, a solution could be to take the word “milk” and alter it somehow, so that a letter is missing or changed. for instance, producers could replace the “i” in “milk” with “y,” making it “mylk.”266 another possibility is omitting the letter “i” altogether, creating the word “mlk.” the well-known protein drink brand “muscle milk” sells its products in the united states and canada.267 due to the labeling laws in canada, the brand was forced to come up with a way of labeling the protein drink in a way that would abide by the regulations set out by the canadian food inspection agency.268 the parent company of the brand ultimately settled on labeling the protein drink products as “muscle mlk.”269 although the 263. see fla. stat. § 502.012 (2020). 264. id. 265. see moreno & berman, supra note 27. 266. see, e.g., iselin gambert, got mylk?: the disruptive possibilities of plant milk, 84 brook. l. rev. 801 (2019). 267. muscle mlk – a uniquely canadian dairy story, miller ip law (may 17, 2018), http://www.milleriplaw.com/blog/2018/5/17/muscle-mlka-uniquely-canadian-dairy-story [https://perma.cc/vp5p-24n6]. 268. id. 269. id. 2022] dairy beloved 425 word “mlk” looks a lot like “milk,” it technically complies with the necessary regulations, and is able to be sold in canadian stores.270 this brings up the point that manufacturers and producers of plant-based beverages should have minimal issues in complying with the standards set out by the fda.271 many companies distribute their products in the united states, as well as in international markets, and thus likely have to have an alternative way of labeling their products anyway.272 making the switch to using the wording or labeling already in place on the international versions of the products is a relatively small change in the long run.273 these changes in labeling would be most effective if paired with widespread consumer education about the importance for a balanced diet, as well as nutrition education efforts aimed at increasing awareness of the nutritional limitations of plant-based beverages.274 many consumers are under-informed when it comes to exactly what different components of nutrition labels mean.275 this causes a problem when it comes time to buy the healthiest option at the grocery store, and even when comparing types of plant-based beverages to milk.276 nutrition education efforts could be directed towards health care providers as well.277 not everyone has access to a dietitian, and so it is important that physicians are wellinformed of the differences between milk and its alternatives when making dietary recommendations.278 vi. conclusion in the future, that local barista who once called out an order for an “iced oat milk latte” may very well start yelling that a “small chai latte made with almond beverage” is ready to be picked up at the counter. grocery store refrigerators will be stocked with cartons labeled “soy drink” and “rice-based beverage.” perhaps even coffee shops and grocery stores will have a guide listing out the nutrients available in the various plant-based options they offer, in an effort to help consumers make the best-informed decision for their family’s nutritional needs. these scenarios may seem like a far-off stretch of the imagination in some respects, but the steps to getting there have already been initiated across the world, and even in certain locations in the united states. the push for legislation to hold manufacturers of plant-based beverages accountable for what they are 270. see id. 271. see sabin, supra note 105. 272. id. 273. id. 274. russell merritt et al., north american society for pediatric gastroenterology, hepatology, and nutrition position paper: plant-based milks, 71 j. pediatric gastroenterology & nutrition 276, 278 (2020). 275. see id. at 278-79. 276. id. 277. id. 278. id. 426 indiana health law review [vol. 19:399 truly selling is also a step in the direction of ensuring the population is healthier as a whole. if consumers are more aware of what they are purchasing and the importance that it has on their nutritional status, there is a lot of potential to reduce many of the health issues that have plagued the united states for much of recent history. differentiating between milk and its plant-based counterparts is just the beginning. there is never going to be a perfect solution to the endless disagreement between what can or cannot be designated as “milk.” chances are, one organization, manufacturer, or individual will always be unhappy with the designation, whether it be dairy farmers or plant-based product companies. the important thing is that there are many differences between cow milk and its plantbased alternatives, enough so that the plant varieties do not deserve the label of “milk.” indiana has already proposed legislation that has previously been declared “dead in the water,” but the fight is long from over. as the popularity of plantbased beverages continues to rise, and the overall concern with nutrition and health status continues to be brought up, being informed on the wide variety of options on the market, and the different nutrients, or lack thereof, that each has to offer is getting increasingly important. for indiana to keep up a status of happy and healthy hoosiers, it is imperative that a change is made. a cross-disciplinary giant at the crossroads of america ross d. silverman, jd, mph* the state motto of indiana is “crossroads of america.” like the state in which she spent more than a quarter of a century as a professor, the work of eleanor kinney—a brilliant, prescient scholar, generous teacher, and founder and long-time leader of the william s. and christine s. hall center for law and health—came to be known for its intersections of law, medicine, health policy, public health, and human rights. my appreciation of eleanor began as something tribal: like eleanor, i, too, had a background in law and public health, and i was a graduate of indiana university. over more than two decades, while i was faculty at southern illinois university and then following my move to indianapolis, eleanor became a colleague, mentor, and regular source of inspiration. she left a tremendous impression on me; i can safely say, were it not for eleanor’s influence on the field of health law, on my alma mater, and on me personally, i would not figuratively and literally, be where i am today. two areas of eleanor’s influence i feel most suited to highlighting in this special edition are her early leadership in empirical health law and in discussing her professional contributions after retiring from indiana university, especially her year as a visiting scholar at southern illinois university. i. an early leader in empirical health law in 2019, health law scholars regularly conduct grant-funded research informed by quantitative and qualitative analyses techniques drawn from health economics, health services research, public health, and the social sciences. more than thirty years ago, eleanor looked around at the indiana university-purdue university-indianapolis campus and noted that, within a few square blocks, she could cross the paths of faculty from the schools of medicine, nursing, dentistry, and social science (including sociology, economics, and psychology). she recognized that bringing together these different voices, with different viewpoints, experiences, and analytical approaches, would make for richer, more pragmatic, and more comprehensive scholarship and training for students. through her grant-funded, multidisciplinary, multi-authored collaborations, resulting in publications in law reviews and reports developed by the hall center, eleanor demonstrated early on how to break down silos to create diverse teams of colleagues and the value of empirics as a means both to inform new policy and to assess extant laws and practices. for a researcher interested in studying issues related to medical malpractice and health care quality and safety, indiana in the late 1980s offered an ideal laboratory. in an effort purportedly to contain the costs of malpractice insurance for indiana providers and ensure continued access to care in the state, indiana in * professor of health policy and management, indiana university richard m. fairbanks school of public health and professor of public health and law, indiana university robert h. mckinney school of law. address all communications to professor silverman at rdsilver@iu.edu 100 indiana health law review [vol. 17:99 1975 had implemented one of the nation’s most restrictive malpractice compensation caps, as well as a patient compensation fund and a malpractice review panel. in 1987, eleanor secured a robert wood johnson foundation grant to study the state’s malpractice system. in a 1990-1991 piece published in the indiana law review, eleanor, collaborating with a sociologist colleague, published an analysis of the impact of the law on providers and claimants.1 the work begins with eleanor and her co-authors offering a “traditional” law reviewstyle analysis of the subject, critiquing recent court decisions interpreting the law’s application.2 it then moves into the world of empirical studies: collecting the more than 6000 malpractice claims filed with the state’s department of insurance from 1975 to 1988, conducting an independent quantitative analysis of this data, contrasting their results with results reported in other states and in a contemporary general accounting office report, and then—using both their own analysis and qualitative information collected from claimant reports on their experience in the indiana malpractice system—discussing the sometimes counterintuitive impact of the law on all parties involved.3 it is a sober, datadriven critique of “the most comprehensive and severe set of insurance and tort reforms in the nation,”4 and a wonderful early example of mixed empirical methods in law scholarship. thanks to eleanor’s commitment to conducting data-driven research, and her building of collaborations across the many health professional schools on the indianapolis campus, the hall center became both a hub and a champion of empirical health law studies, focused on “enhanc[ing] access to high-quality care for the most vulnerable of our society who are often excluded from the tremendous capabilities and services of the american health care system.”5 as she and david orentlicher state in a piece celebrating the hall center’s 10th anniversary: since 1987, the center has engaged in many empirical studies addressing such topics as medicare coverage policy, quality improvement for community-based, long-term care, barriers to health insurance for people with serious illness and designing strategies for expanding health coverage for the working poor. in addition, professor kinney has conducted many studies of grievance and appeal procedures as well as rule and policy asking procedures for the medicare and medicaid programs with support from the administrative conference of 1. eleanor d. kinney, william p. gronfein & thomas p. gannon, indiana’s medical malpractice act: results of a three-year study, 24 ind. l. rev. 1275 (1991). 2. id. at 1281-85. 3. see id. at 1285-1305. 4. id. at 1302. 5. eleanor d. kinney & david orentlicher, lies, damn lies and statistics: how empirical research shapes health law and policy, a symposium in celebration of the tenth anniversary of the center for law and health symposium: introduction, 31 ind. l. rev. 9, 10 (1998). 2020] a cross-disciplinary giant at the crossroads of america 101 the united states.6 eleanor sought to overcome the limitations of traditional health law scholarship that would focus its policy analysis where the lights were brightest. even today, as we build out the field of legal epidemiology, surveillance will frequently focus on analyzing the “black letter law” of statutory and regulatory sources. two decades ago, she described the critical, under-examined role of private entities in forming and shaping health policy. as she notes: understanding how private organizations make policy is essential as policy is used extensively in many contexts . . . yet policy science and legal scholarship have accorded little attention to how private organizations make policy that is used in public benefit and regulatory programs or otherwise affects important aspects of national life. [focusing instead on] how interest groups exert influence on legislative and regulatory bodies and what legislators, regulators, and judges do as a result. . . . . . . [l]egal and social science scholarship to date have not really described or examined critically the policy making processes of private organizations. this gap is troubling given the importance of private policy on nearly all aspects of public life.7 drawing upon her experience with medical malpractice regulation, health care quality, and health services research, eleanor in 1999 was one of the early health law scholars to take interest in what eccles and mittman would, some seven years later, introduce as the field of implementation science, “the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services,” as facilitated through policy.8 using the example of diabetes management policy, she outlines the process through which scientific insights into disease pathways find their way into clinical practice, then evolve into practice guidelines and quality standards promoted by private medical organizations, then get translated into quality performance measures imposed by private accrediting bodies, then are used by health insurers to enforce practice standards, 9 and then may eventually make their way into statutes and regulations (which can then be assessed for their effectiveness). eleanor recognized early on the value of empirical, “evidencebased” policymaking and policy analysis. to borrow a quote from my legal 6. id. at 9. 7. eleanor d. kinney, behind the veil where the action is: private policy making and american health care recent developments, 51 admin. l. rev. 145, 150-51 (1999). 8. martin p. eccles & brian s. mittman, welcome to implementation science, 1 implementation sci. 1 (2006). 9. kinney, supra note 7, at 180-83. 102 indiana health law review [vol. 17:99 epidemiology colleagues, writing a dozen years later, eleanor understood early on that “what gets measured, gets changed.”10 eleanor would continue throughout her career to promote opportunities to bring empirically-grounded fields like health services research into legal scholarship in order to develop evidence-informed and evidence-driven health policy.11 i feel one of the most important empirical studies eleanor conducted was one she published in 2004. building on her 2001 piece (originally a lecture), “the international human right to health: what does this mean for our nation and world lecture,”12 eleanor (with co-author brian clark), published “provisions for health and health care in the constitutions of the countries of the world” in the cornell international law journal.13 this tour de force represents an early, highly influential example of public health law research,14 or what we now call legal epidemiology scholarship15 or policy surveillance.16 inspired by her philosophical belief in society assuring some form of right to health care for vulnerable populations (even if not guaranteed under u.s. jurisprudence), and building upon expanding international support for the human right to health, eleanor and her co-author looked at the constitutions of united nations member-states to assess whether state constitutions explicitly conferred 10. see jamie f. chriqui, jean c. o’connor & frank j. chaloupka, what gets measured, gets changed: evaluating law and policy for maximum impact, 39 j.l. med. & ethics supp. 1 21 (2011). 11. see, e.g., eleanor d. kinney, prospects for comparative effectiveness research under federal health reform, 21 annals health l. 79 (2012). 12. eleanor d. kinney, the international human right to health: what does this mean for our nation and world lecture, 34 ind. l. rev. 1457 (2001). 13. eleanor d. kinney & brian alexander clark, provisions for health and health care in the constitutions of the countries of the world, 37 cornell int’l l.j. 285 (2004). 14. see generally scott burris, alexander c. wagenaar, jeffrey swanson, jennifer k ibrahim, jennifer wood & michelle m mello, making the case for laws that improve health: a framework for public health law research, 88 milbank q. 169, 172 (2010) (contrasting the concept of public health law “research” – “the use of systematic [, generally empirical,] methods within an explicit theoretical framework to collect and analyze data” from public health law “scholarship” – research on legal issues in public health grounded in nonempirical fields such as philosophy, ethics, or legal analysis). 15. see generally tara ramanathan, rachel hulkower, joseph holbrook & matthew penn, legal epidemiology: the science of law. 45 j.l. med. & ethics supp. 1 69, 69 (2017) (explaining legal epidemiology as a form of transdisciplinary, systematic public health law research defined as “the scientific study and deployment of law as a factor in the cause, distribution, and prevention of disease and injury in a population”). 16. see generally scott burris, laura hitchcock, jennifer ibrahim, matthew penn, & tara ramanathan, policy surveillance: a vital public health practice comes of age, 41 j. health pol. pol’y & l. 1151, 1151 (2016) (defining policy surveillance as “the systematic, scientific collection and analysis of laws of public health significance.” it is the most rigorous form of legal epidemiology research). 2020] a cross-disciplinary giant at the crossroads of america 103 a right to health or health care to their people.17 they then examined whether states conferring such rights backed up these constitutional proclamations with further action.18 they created a typology of five different types of constitutional provisions addressing health or health care: aspirational statements, entitlement statements, statements of duty, statements referring to specific approaches to delivering health services, and statements incorporating international and/or regional treaties recognizing a human right to health.19 they found that two-thirds of all nation’s constitutions contained a provision addressing health or health care.20 however, they also found that (a) the absence of such a constitutional provision did not also mean the absence of support for such services through other state policies; in fact, they found a number of states that extensively supported their citizens’ health despite not having such a commitment in their highest law; and (b) “not all of the countries that have provisions regarding health and health care in their constitutions have in practice lived up to these mandates. some of the most resounding constitutional commitments to health and health care are in poor countries with tenuous democracies” and scant investment in health infrastructure.21 in fact, their empirical analysis found an obverse correlation: the number or strength of constitutional provisions does not appear to have a determinative role in the amount of resources that countries spend for the health care of their populations. specifically, countries that expressed the greatest constitutional commitment to health—evidenced by inclusion of both a statement of entitlement and duty—had an average government per capita expenditure for health care of $308 in 2000. however, the same average for countries that had no provision regarding health or health care was $716.95.22 while eleanor and her coauthor were not surprised by this finding, they did feel that the widespread inclusion of such constitutional provisions served as both progress toward universal international recognition of a human right to health, as well as a policy imperative for those underperforming countries to pursue.23 this article’s integration of issues of health law, policy, and human rights, and its use of empirical analytical techniques to hold states accountable for the implementation of promises expressed in law, has been a significant influence on and inspiration to me as a scholar. cited nearly 200 times, it also has been widely appreciated by legal, medical and human rights scholars around the globe. 17. kinney & clark, supra note 13, at 291-93. 18. id. at 294-98. 19. id. at 189-90. 20. id. at 287. 21. id. 22. id. at 295. 23. id. at 298. 104 indiana health law review [vol. 17:99 ii. a model for life-long learning eleanor’s may 2011 retirement from indiana university was not her final chapter as a teacher or scholar. it would be enough to say that eleanor was committed to lifelong growth and learning, but i believe there was more to it than that. having spent decades analyzing public health insurance, health care quality and safety, and health reform, she was not about to sit silently by and watch as the affordable care act transformed american health care. in 2012-2013, she joined me as a colleague at southern illinois university, where she was named that academic year’s garwin distinguished visiting professor of law and medicine. while at siu, she taught multiple courses and delivered several public lectures, all of which focused on inspiring her listeners to understand how health law can protect society’s most vulnerable and to be advocates for their clients and patients, as well as their professions. she offered law school courses in the law of the medicare program and health policy law, as well as a seminar on health reform topics. these courses were practically oriented, helping her students prepare for a future of answering difficult client questions at the intersection of multiple disciplines. as i served as editor-in-chief of the journal of legal medicine, which at the time was affiliated with southern illinois university school of law, i also saw how her work resonated with our most engaged health law students and translated into publications inspired by her tutelage.24 she also shared her enthusiasm for international health law with our students deep in rural southern illinois, bringing them a course on health and human rights in a global market that examined how international regulatory bodies and agreements affected issues of intellectual property, drug and device marketing, and the human right to health. in addition to offering her the opportunity to discuss national issues such as the implementation of the affordable care act, eleanor’s new location 200 miles southwest of indianapolis gave her a fantastic vantage point to observe and comment upon contentious developments in another core area of her expertise, medical malpractice. while indiana had a very stringent, practically unassailable cap on damages in place for three decades, in february 2010, the illinois supreme court struck down its compensatory damage cap.25 this opened up a heated political battle.26 one that was still raging as election day 2012 approached. on september 27, 2012, eleanor delivered the dr. arthur grayson distinguished lecture to the carbondale community.27 her lecture, titled “physicians and 24. see erin bradley, accountable care organizations antitrust guidelines will not save rural providers, 34 j.l. med. 295 (2013). 25. lebron v. gottlieb memorial hospital, 930 n.e.2d 895 (ill. 2010). 26. sean stonefield, a third strike for tort reform, chi. trib. (dec. 8, 2011), https://www.chicagotribune.com/chi-tort-reform-20111208-story.html [https://perma.cc/wr53g7bh]. 27. greyson lecture-past programs, southern ill. sch. of l., https://law.siu.edu/ academics/center-programs/health-law-policy/grayson-lecture-past.html [https://perma.cc/u3fqntbg]. 2020] a cross-disciplinary giant at the crossroads of america 105 health law at an impasse: what can be done?” spoke directly to the instability area physicians felt concerning malpractice as well as health care reform.28 the following spring, eleanor traveled to springfield, illinois to deliver the theodore r. leblang distinguished lecture before a full auditorium of faculty, students, and staff at southern illinois university school of medicine.29 the lecture, titled “the affordable care act: what’s in it for physicians,”30 was delivered as part of the school of medicine’s fourth-year medical school curriculum on the physician and society, when students would have an opportunity to gain a greater understanding of the regulation of the u.s. healthcare system, the social determinants of health, and their role as advocates for their profession, their patients, and their communities. the lecture was a tour de force, tracing the history of the corporate transformation of the u.s. healthcare system, describing the ever-increasing layers of oversight and bureaucracy those systems impressed upon physician practices, and sharing her prediction that the most impactful component of the affordable care act would be its facilitation of value-driven accountable care organizations. she closed the lecture with a call for physicians to take back clinical control of the content and quality of medical care, encouraging them to step up and take on stronger roles in political and corporate health care settings. she continued to publish following her indiana university retirement, including three law review articles,31 a book on health care reform,32 a nutshell book on administrative law of health care,33 an article on administrative law and medicare,34 and articles on medical malpractice, access to care, and medical device regulation. eleanor kinney is a role model for lifelong learning and commitment to making an intellectual impact. 28. id. 29. lecture archive, siu sch. of med, https://www.siumed.edu/medhum/lecturearchive.html [https://perma.cc/fdh2-rpu9]. 30. id. 31. see eleanor d. kinney, prospects for comparative effectiveness research under federal health reform, 21 annals health l. 79 (2012); eleanor d. kinney, the affordable care act and the medicare program: linking medicare payment to quality performance, 68 n.y.u. ann. surv. am. l. 567 (2013); eleanor d. kinney, the affordable care act and the medicare program: the engines of true health reform, 13 yale j. health pol’y l. & ethics 253 (2013). 32. see eleanor d. kinney, the affordable care act and medicare in comparative context (2015). 33. see eleanor d. kinney, administrative law of health care in a nutshell (2017). 34. see eleanor d. kinney, the accidental administrative law of the medicare program, 15 yale j. health pol’y l. & ethics 111 (2015). the constitutional strength of indiana’s medical review panel process: how to overcome the inevitable challenges anna karas* i. introduction beginning in the 1970s, states started implementing medical review panels, also known as screening panels, in response to a medical malpractice crisis.1 a rise in medical malpractice claims resulted in an increase in the cost of medical malpractice insurance.2 so much so, that in some states, the high cost of malpractice insurance was said to be driving certain specialties of doctors to leave the state due to the high risk of a lawsuit.3 arizona was the first state to implement medical review panels in 1976 with the goal of having a group of health care professionals evaluate medical malpractice cases before they were filed in court.4 the hope was that the panels would create a more time and costefficient way to resolve these disputes.5 since arizona’s implementation of medical review panels, at least seventeen states, including indiana, have created similar screening panels.6 medical review panels have been constitutionally challenged on various grounds from their inception.7 these challenges have involved arguments based on equal protection, due process, separation of powers, right to a jury trial, and openness to the courts.8 while states such as indiana have upheld their medical review panel processes,9 similar statutes in other states have been held to be unconstitutional.10 medical review panels are only one mode of tort reform that is reshaping * j.d. candidate, 2021, indiana university robert h. mckinney school of law; b.a., 2017, purdue university. 1. jean macchiaroli eggen, medical malpractice screening panels: an update and assessment, 6 j. health & life sci. l. 1, 3 (2013). 2. id. 3. john gregory, medical review panels for malpractice claims, ket (feb. 6, 2017), https://www.ket.org/public-affairs/medical-review-panels/ [https://perma.cc/r4zd-u4c8]. 4. courtney a. simpkins & joseph l. fink iii, mrps are both a blessing and a curse, pharmacy times (sept. 25, 2019), https://www.pharmacytimes.com/publications/issue/2019/ september2019/mrps-are-both-a-blessing-and-a-curse [https://perma.cc/9xjt-8de6]. 5. id. 6. id. 7. andrew wilhoit, improper means to a kalopsian end: an analysis of medical review panels under kentucky’s constitution, 57 u. louisville l. rev. 439, 439 (2019). 8. id. 9. see generally james d. kemper et al., reform revisited: a review of the indiana medical malpractice act ten years later, 19 ind. l. rev. 1129 (1986). 10. wilhoit, supra note 7. 190 indiana health law review [vol. 18:189 medical malpractice litigation across the country.11 the review panels were introduced with many goals in mind, but how well the panels have met and are currently meeting those goals is questioned.12 these circumstances, and the constitutional claims brought across the country that are revealing a divide among states on how to respond, present an opportunity to revisit the indiana medical malpractice act. a look into the indiana medical malpractice act with this foresight may uncover areas in it that can be improved or modified to ensure it remains in effect through future challenges. the first part of this note discusses the history of indiana’s medical malpractice act and the current format of medical review panels. the second part presents a discussion of the recent kentucky supreme court decision that held the state’s medical review panel statute unconstitutional. third, this note compares the indiana supreme court’s view of medical review panels to that of kentucky’s, followed by a discussion of whether the goals of medical review panels are being met. next, this note inquires why medical review panels cause such a delay in the system and whether there is still a medical malpractice crisis in the country. lastly, alternatives to medical review panels are discussed, followed by suggestions to make the proceedings of a medical malpractice case more efficient. ii. indiana’s medical malpractice act a. general history in the 1970s, indiana began looking at ways to fix the health care system that was “on the verge of a crisis.”13 indiana’s governor at the time, governor otis r. bowen, was a medical doctor himself.14 governor bowen saw the need for changes in the medical malpractice system in indiana and requested the legislature to evaluate the same.15 the indiana medical malpractice study commission (“commission”) was created to study medical malpractice adjudication in indiana and how residents of indiana were affected by the current statutory scheme.16 the commission published its findings for 1975 to 1976, concluding there had been a 410% increase in the average medical malpractice insurance premiums for physicians from 1970 to 1975.17 there had also been a 42% increase in the frequency of claims filed against physicians in indiana, and 11. lydia nussbaum, trial and error: legislating adr for medical malpractice reform, 76 md. l. rev. 247, 271-72 (2017). 12. see eggen, supra note 1, at 3-4; see also nussbaum, supra note 11, at 271. 13. otis r. bowen, medical malpractice law in indiana, 11 j. legis. 15, 15 (1984). 14. ashley bullock green, no “new” breaches: adding a section to the indiana medical malpractice act to alleviate the pain caused by k.d. v. chambers, 49 val. u. l. rev. 955, 959 (2015). 15. id. at 960. 16. bowen, supra note 13, at 15 n.1. 17. id. at 15. 2021] the constitutional strength of indiana’s medical review panel process 191 the average damage award had increased from $12,993 in 1970 to $34,297 in 1975.18 further, the commission uncovered a practice that greatly affected hoosiers: 65% of physicians in indiana admitted having ordered procedures for patients that they considered “superfluous” due to a fear of being sued.19 the commission also examined the various reasons for the increase in medical malpractice claims.20 the commission found that patients were “more aware of medical malpractice and the legal redress available to them.”21 additionally, patients had a greater expectation that a cure or better outcome would be obtained, which led to increased disappointment if the same did not occur.22 there was also a finding of “increasing deterioration of the rapport between doctors and patients,” which likely led to an increased number of claims.23 the commission reported that physicians were not only significantly affected by the increase in malpractice claims but also by the increased cost of malpractice insurance.24 the heightened expense for malpractice insurance reportedly caused some physicians to practice with inadequate coverage or forego insurance altogether.25 this was especially true for physicians in high-risk specialties, such as surgeons and obstetrician-gynecologists;26 patients tend to expect more from specialists, and they do not have the same close relationship with specialists as compared to their family doctors.27 in response to the commission’s findings, the indiana general assembly enacted indiana’s medical malpractice act (“act”) in 1975.28 among the provisions, the act capped the total amount of damages plaintiffs could recover, while also creating the review panel process to screen medical malpractice claims prior to being filed in state court.29 b. medical review panels an important aspect of the medical malpractice act was the introduction of medical review panels. medical review panels were implemented to review “all 18. id. 19. id. 20. see id. at 16. 21. id. 22. id. 23. id. 24. id. 25. id. 26. the doctors most likely to hear, ‘we’ll see you in court,’ advisory board (nov. 17, 2017) h ttp://www.advisory.com/daily-briefing/2017/11/17/medscape-malpract ice [https://perma.cc/ga8n-qxqb]. 27. bowen, supra note 13, at 16. 28. kemper et al., supra note 9, at 1129. 29. id. at 1130. 192 indiana health law review [vol. 18:189 proposed malpractice complaints.”30 the purpose of these panels is to review the evidence of both parties and provide an opinion as to whether or not the case is one of malpractice.31 medical review panels in indiana consist of three health care providers and one non-voting attorney chairman.32 once the attorney chairman is chosen either by agreement of the parties or striking panels, the parties begin to select health care providers to be on the panel.33 when there are one plaintiff and one named defendant, each party selects one health care provider, and the first two members chosen will select the third panelist.34 the first two panelists are either nominated by the parties, or the parties individually choose a specialty, and then striking panels of candidates are distributed to select the members.35 by statute, if there is one individual defendant, at least two of the members of the medical review panel must be of the same specialty.36 when the case involves multiple defendants of various specialties, serious delays can arise because the parties often want to ensure that their respective specialty is represented on the threemember panel.37 the potential for delays does not stop there. if a party chooses to nominate a health care provider, the other side can challenge the selection without cause.38 the parties are given two opportunities to nominate physicians for the medical review panel.39 if both selections are challenged, the panel chairman creates a striking panel of three physicians and each side takes turns striking providers from the list until one remains.40 parties have to conduct internal conflict checks and perform research on the candidates listed in the striking panels, and the defendants have to confer and agree as to a joint strike. with parties having to conduct conflict checks and research on the members listed in the striking panels, as well as defendants having to confer and agree as to a joint strike, the process of seating the medical review panel can take weeks or months.41 once the panel is formed, the statute provides that the panel is to render its opinion within 180 days of selecting the final panel member.42 however, even with the 180-day deadline, the panel rarely gives its opinion within that time.43 this is due to various reasons, including the replacement of panel members, 30. bowen, supra note 13, at 22. 31. id. 32. ind. code § 34-18-10-3 (2020). 33. see ind. code § 34-18-10-6 (2020). 34. id. 35. see id. 36. ind. code § 34-18-10-8 (2020). 37. see ind. code §§ 34-18-10-7 to -8 (2020). 38. ind. code § 34-18-10-10 (2020). 39. id. 40. id. 41. see eggen, supra note 1. 42. ind. code § 34-18-10-13 (2020). 43. kemper et al., supra note 9, at 1133. 2021] the constitutional strength of indiana’s medical review panel process 193 waiting on submissions from all parties, and finding a time to convene the panel that works for all panelists.44 after the panel members review all the materials provided to them and meet to discuss the evidence, the statute provides four opinions that they can reach: (1) the evidence supports the conclusion that the defendant or defendants failed to comply with the appropriate standard of care as charged in the complaint. (2) the evidence does not support the conclusion that the defendant or defendants failed to meet the applicable standard of care as charged in the complaint. (3) there is a material issue of fact, not requiring expert opinion, bearing on liability for consideration by the court or jury. (4) the conduct complained of was or was not a factor of the resultant damages. if so, whether the plaintiff suffered: (a) any disability and the extent and duration of the disability; and (b) any permanent impairment and the percentage of the impairment.45 after the panelists meet and form their opinion, the opinion is admissible evidence in court if the case proceeds to trial, but the opinion is not conclusive.46 iii. the recent kentucky supreme court decision: commonwealth v. claycomb in 2017, kentucky enacted the medical review panel act, creating a medical review panel process.47 the kentucky lawmakers modeled their review process after indiana’s, with a few minor changes.48 the medical review panel act gave the panel members nine months to issue an opinion as to whether or not the plaintiff had a valid claim.49 the law was quickly challenged by the parents of a young boy who was born with brain damage and cerebral palsy.50 the parents sued their family physician.51 they argued, among other things, that the panel 44. id. at 1134; § 34-18-10-13. 45. ind. code § 34-18-10-22 (2020). 46. ind. code § 34-18-10-23 (2020). 47. tanya albert henry, top kentucky court strikes down law on medical review panels, ama (dec. 10, 2018), https://www.ama-assn.org/health-care-advocacy/judicial-advocacy/topkentucky-court-strikes-down-law-medical-review-panels [https://perma.cc/5b6v-txy5]. 48. see ky. rev. stat. ann. ch. 216c (west repealed 2020). 49. anjelica cappellino, how are medical malpractice review panels impacting the legal process, expert inst. (aug. 30, 2018), https://www.theexpertinstitute.com/are-medicalmalpractice-review-panels-helping-or-hindering-the-legal-process/ [https://perma.cc/a8p5-pusv]. 50. id.; commonwealth v. claycomb, 566 s.w.3d 202, 206 (ky. 2018). 51. cappellino, supra note 49. 194 indiana health law review [vol. 18:189 process created an unreasonable delay that violated the open courts guarantee under the kentucky constitution.52 in a unanimous decision, the supreme court of kentucky held that the medical review panel act were unconstitutional.53 the court reasoned that because the statute created a mandatory delay for individuals trying to file medical malpractice claims, the statute was in violation of section 14 of the kentucky constitution.54 section 14 provides that “[a]ll courts shall be open, and every person for an injury done him in his lands, goods, person or reputation, shall have remedy by due course of law, and right and justice administered without sale, denial or delay.”55 iv. analysis a. indiana’s constitutional analysis of medical review panels although the kentucky medical review panel act was modeled after indiana’s medical malpractice act, the supreme court of kentucky used a different constitutional analysis than the supreme court of indiana when it reviewed the constitutionality of the kentucky act. in 1980, the constitutionality of indiana’s medical malpractice act was challenged in the case of johnson v. st. vincent hospital.56 in johnson, the plaintiffs contended that the delay and expense in getting to a jury trial caused by the act was unconstitutional based on both article i, section 20 and article i, section 12 of the indiana constitution.57 the court in johnson first reasoned that the act did not take away the right to a jury trial because the delay and cost that the act imposed did “not alter or change and [did] not impair the right contrary to constitutional limitation.”58 the court also explained that the requirement of plaintiffs submitting their case to a panel was a reasonable requirement meant to help the state manage the large amounts of malpractice claims it was facing.59 one justification for the delay offered by the court was that the panel process “generates evidence admissible at a future trial of the claim.”60 because delays are part of any case, the time spent producing evidence for the medical review panel “reduce[d] total aggregate time 52. id.; claycomb, 566 s.w.3d at 206. 53. claycomb, 566 s.w.3d at 206. 54. id. at 213; henry, supra note 47. 55. ky. const. § 14. 56. johnson v. st. vincent hosp., 273 ind. 374, 378 (1980). 57. id. at 382-83, 386; see ind. const. art. i, § 20 (“in all civil cases, the right of trial by jury shall remain inviolate”); see also ind. const. art. i, § 12 (“all courts shall be open; and every person, for injury done to him in his person, property, or reputation, shall have remedy by due course of law. justice shall be administered freely, and without purchase; completely, and without denial; speedily, and without delay.”). 58. johnson, 273 ind. at 384. 59. id. 60. id. 2021] the constitutional strength of indiana’s medical review panel process 195 for trial preparation.”61 thus, the delay did not violate the right to a jury trial.62 as to the article i, section 12 claim, the court admitted there was a delay, even characterizing the restriction on accessing the courts as “severe.”63 however, the court interpreted the indiana constitution to mean that if the delay was “reasonable in light of th[e] aim” to “preserve health care services,” it would be constitutional.64 the court explained that an important goal of the act was to “preserve health care services for the community.”65 it concluded the delay would allow the medical review panel to form an expert opinion using their “knowledge and experience,” as well as “encourage the mediation and settlement of claims and discourage the filing of unreasonably speculative lawsuits.”66 the court noted that other indiana laws also impose delays before a plaintiff can file a lawsuit, 67 such as the requirement of “prepay[ing] court costs” or “proof of indigency at the time of filing suit.”68 although the act does result in a delay to the plaintiffs’ access to courts, the court found that the delay was reasonable and therefore upheld the act as constitutional.69 b. kentucky’s constitutional analysis of medical review panels in commonwealth v. claycomb, the supreme court of kentucky distinguished their case from johnson in holding that kentucky’s medical review panels were unconstitutional.70 the kentucky court began its opinion by stating that, in their view, the “guarantee of a right of access to the courts” could be the most important right in state constitutions not otherwise included in the bill of rights.71 although the provisions of the indiana and kentucky constitutions that were relevant to the challenges were almost identical, the kentucky court disagreed with indiana’s analysis.72 the kentucky court stated that their open 61. id. 62. id. 63. id. at 390. 64. id. at 384-90. 65. id. at 388. 66. id. at 388-89. 67. id. at 389. 68. id. 69. id. at 390. 70. commonwealth v. claycomb, 566 s.w.3d 202, 204 (ky. 2018). 71. id. 72. see id. at 217; compare ky. const. § 14 (“all courts shall be open, and every person for an injury done him in his lands, goods, person or reputation, shall have remedy by due course of law, and right and justice administered without sale, denial or delay.”), with ind. const. art. 1 § 12 (“all courts shall be open; and every person, for injury done to him in his person, property, or reputation, shall have remedy by due course of law. justice shall be administered freely, and without purchase; completely, and without denial; speedily, and without delay.”). 196 indiana health law review [vol. 18:189 courts provision applies to both the legislature and the judiciary,73 while indiana had applied their open courts provision only to the judiciary.74 although delays are inherent in court proceedings, the court held the delay caused by medical review panels was unconstitutional because it “usurp[ed]” a plaintiff’s “freedom to access the adjudicatory method of his or her choosing at the time of his or her choosing.”75 the mandatory delay caused by the kentucky statute was troublesome to the court because it was “as though no ‘course of law’ [was] taking place whatsoever” during the delay, resulting in no “due course of law” in the proceedings.76 v. are the goals of medical review panels being met? with states such as kentucky ruling medical review panels unconstitutional and frustrations from both sides about the delays caused by them, there may be areas in the indiana act that could be modified to reduce the amount of time the panel process takes. indiana’s panel process was held constitutional in 1980, but the increasing delays are more unreasonable than they were forty years ago.77 when medical review panels were initially implemented across the country, legislators had many goals they hoped to achieve. the new hampshire medical review panel statute includes a list of goals that are typical of many other states that have enacted this type of tort reform. these goals include: (1) making medical liability insurance available and affordable; (2) protecting patients and providing access to medical care for consumers; (3) keeping down the costs of resolving medical negligence disputes; (4) resolving claims speedily and inexpensively, preferably without resorting to the court system; and (5) identifying early in the process which claims have merit.78 over the years, studies have been conducted to examine these goals to see if the panels are achieving what they were implemented to do.79 while the results of these studies have varied, many have shown that the panels may not be as effective as they were originally thought to be.80 in 1985, a study concluded that medical review panels did not have an effect on reducing the total number of medical malpractice claims filed.81 on the contrary, the study found that these 73. claycomb, 566 s.w.3d at 217. 74. smith v. ind. dep’t of corr., 883 n.e.2d 802, 808 (ind. 2008) (“[t]he open courts clause does not prohibit all conditions on access to the courts, but it does prevent the legislature from arbitrarily or unreasonably denying access to the courts to assert a statutory or common law cause of action that is in itself unmodified and unrestricted.”). 75. claycomb, 566 s.w.3d at 213 (emphasis omitted). 76. id. 77. see johnson v. st. vincent hosp., 273 ind. 374 (1980). 78. n.h. rev. stat. ann. § 519-b:1(i) (2020). 79. eggen, supra note 1, at 24. 80. id.; see also nussbaum, supra note 11, at 271. 81. eggen, supra note 1, at 24; patricia munch danzon, new evidence on the frequency and severity of medical malpractice claims 21 (1986); see nussbaum, supra 2021] the constitutional strength of indiana’s medical review panel process 197 statutes may even encourage individuals to file claims because they could “reduc[e] the cost to the plaintiff of obtaining expert testimony.”82 further, medical review panels may not reduce the time or cost of litigating medical malpractice claims.83 in most cases, in order to provide all the requisite evidence to the panel members, both parties will have to conduct discovery at an earlier stage of the case, which will delay the panel and add costs to litigation.84 a 1992 study found that states with medical review panels had a higher rate of malpractice litigation.85 on one hand, this finding could indicate that states with higher litigation are more likely to implement screening panels.86 on the other hand, this could also indicate that the panels are not reducing the litigation as they were thought to do.87 while these studies show that the panel process can be ineffective, others have taken an opposing view and found that any downfalls involved with the statutes are outweighed by the benefits gained.88 in 2008, pinnacle actuarial resources, inc. concluded that states with “screening panels” had malpractice insurance rates about 20% below the national average.89 these states also had lower claim costs and a higher rate of cases closed without payment.90 the study also found panels typically heard claims within six months of the filing, which would make them very effective.91 while this study vindicates supporters of medical review panels, it should be noted that this study was done at the request of the american medical association.92 as with many health care providers and their organizations, the american medical association is an organization that favors medical review panels.93 while delays in any panel process are inevitable, the statutory language can be a factor in the actual length of the delay.94 state statutory language varies in how long the process should last.95 some states, such as indiana, provide a note 11, at 271. 82. danzon, supra note 81 (footnote omitted). 83. nussbaum, supra note 11, at 271. 84. id. 85. eggen, supra note 1, at 25; catherine t. struve, expertise in medical malpractice litigation: special courts, screening panels, and other options 56 (2003). 86. eggen, supra note 1, at 25; struve, supra note 85, at 60. 87. see eggen, supra note 1, at 25; see also struve, supra note 85, at 64-65. 88. eggen, supra note 1, at 25. 89. id.; litigation screening panels on trial: are they working?, am. med. news (aug. 3, 2009), https://amednews.com/article/20090803/profession/308039980/4/ [https://perma.cc/ dwc3-g83h]. 90. eggen, supra note 1, at 25. 91. litigation screening panels on trial: are they working?, supra note 89. 92. id. 93. id. 94. see eggen, supra note 1. 95. see id. 198 indiana health law review [vol. 18:189 deadline based upon the date the final panel member is selected.96 these deadlines vary from thirty to 180 days.97 some states give limitations within which the panel hearing must be held, and still, others do not specify a time period in their statutes at all.98 as seen in the kentucky decision in claycomb, even with statutory deadlines, courts have struck down these statutes due to their delays.99 and, as many of these states have shown, the deadlines do little to prevent panels from lasting months or even years past the deadline.100 while kentucky may be the most recent to rule their statute unconstitutional, it is not alone in viewing these panels as problematic. in 1983, the rhode island supreme court found that its medical review panel statute unconstitutional.101 the court held the statute violated the equal protection clause of the united states constitution because the insurance crisis that existed when the statute was enacted was no longer a crisis that needed a statutory remedy.102 the supreme court of missouri also held its statute unconstitutional in 1979.103 this court found that the statute violated the plaintiff’s right of access to the courts by imposing what was described as an “arbitrary delay.”104 in 1980, the pennsylvania medical review statute was held unconstitutional “because the delays involved in processing the[] claims under the prescribed procedures set up under the [statute] result[ed] in an oppressive delay and impermissibly infringe[d] upon the constitutional right to a jury.”105 the new hampshire state bar has been critical of its state’s screening panel statute. although there is a statutory time limit of eleven months, a superior court report in 2008 found that the average time between the start of the screening panel process and the start of the panel hearing was much longer, at 560 days.106 this average time of 560 days is even longer than the average time to trial in new hampshire.107 vi. what’s causing the delay? while a quick process may have been envisioned when medical review 96. see id. 97. see id. 98. see id. 99. see id.; commonwealth v. claycomb, 566 s.w.3d 202, 205 (ky. 2018) (“any action involving a dependent claim accruing after june 29, 2017, shall be immediately and automatically stayed until . . . (b) nine (9) months after the filing of the proposed complaint if the panel has not given its opinion.”). 100. see eggen, supra note 1. 101. boucher v. sayeed, 459 a.2d 87, 93 (r.i. 1983). 102. id. 103. state ex rel. cardinal glennon mem’l hosp. for children v. gaertner, 583 s.w.2d 107, 110 (mo. 1979). 104. id. 105. mattos v. thompson, 421 a.2d 190, 196 (pa. 1980). 106. eggen, supra note 1, at 27. 107. id. 2021] the constitutional strength of indiana’s medical review panel process 199 panels were first created, the delays in the system now can be extreme. a backlog of cases is one cause of the delay.108 an example of the backlog is the commonwealth of pennsylvania, in which a panel process was created with a panel of seven but the program was later terminated, with officials concluding that the process was “an ambitious state program” that fell “woefully short of [its] promise.”109 while the process was in place, there were 2,466 claims filed and a mere nine cases reached the hearing stage.110 further, less than 10% of the claims had been settled or discontinued.111 one can only imagine the backlog now, around forty years later. the backlog of cases in other states is undoubtedly causing similar issues. in 2015, indiana lawmakers received varying opinions about the medical review panel process.112 testimony from an attorney on behalf of the indiana trial lawyers association, an organization of plaintiff’s attorneys, revealed that, in the attorney’s experience, the average time for a panel decision to be rendered after the panel is formed is over two years when it should ideally be completed in a year or less.113 while there are deadlines throughout the panel process, including the panel formation and selection, an attorney who defends health care providers testified that nobody wants the deadlines enforced 95% of the time.114 one reason for this may be that the panel process is seen as “informal,” so the need to meet deadlines is not great.115 there are remedies for intentional delays in the process, but it is rare for attorneys to enforce the deadlines through the courts.116 delays can originate at the very beginning of the panel process when the parties choose an attorney to be the panel chair.117 if the parties agree on who should serve as the panel chair, this stage of the process is completed.118 however, agreement amongst the parties is rare.119 without a consensus, the clerk of the indiana supreme court provides a random list of five attorneys to the 108. nussbaum, supra note 11, at 271; nicole l. kaufman, the demise of medical malpractice screening panels and alternative solutions based on trust and honesty, 28 j. legal med. 247, 256 (2007). 109. edelson v. soricelli, 610 f.2d 131, 136 (3d cir. 1979); kaufman, supra note 108. 110. edelson, 610 f.2d at 136; kaufman, supra note 108. 111. edelson, 610 f.2d at 136; kaufman, supra note 108. 112. dave stafford, the waiting game delays medical malpractice claims going to court, ind. law. (oct. 6, 2015), https://www.theindianalawyer.com/articles/38382-the-waiting-gamedelays-medical-malpractice-claims-going-to-court [https://perma.cc/na2x-yfez]. 113. id. 114. id. 115. id. 116. id. 117. id. 118. id. 119. id. 200 indiana health law review [vol. 18:189 parties and the parties take turns striking the names until one is left.120 a similar process is implemented when choosing the members of the panel.121 if the parties agree to a panelist nominated by the other side, the process would be much quicker, but again, agreement of the parties is rare and either side can challenge nominations made by the opposing party.122 after the panel is formed, the statute provides that an opinion should be rendered within 180 days.123 however, this deadline is often extended by requests of the parties, due to disputes relating to discovery, or other issues.124 the number of panel members can also have an effect on the length of time the panel process takes.125 states vary between three, as in indiana, to seven members.126 fewer panelists make it easier to coordinate a date and time for the panel to convene, and it takes less time to form the panel.127 however, when there are multiple defendants, which is very common in malpractice cases, delays are likely to be caused by the parties having to decide which three specialties will be chosen for the panel and which ones will be left out.128 additionally, the level of cooperation between physicians and attorneys can be very low.129 asking a group of busy doctors to take time away from work to study and examine what could be hundreds of pages of submissions and medical records does not always result in a quick convening of the panel. not only do the doctors need to find the time to convene the panel and review the materials but they also need to find a time that works for all of the panelists which can contribute to the already belated panel process. vii. is there still a medical malpractice crisis? by 2009, there were approximately 29.5% fewer medical malpractice claims in the united states than in 2003.130 while some believe there is still a health care insurance crisis in the united states, others disagree.131 this debate is very 120. id. 121. id. 122. id. 123. ind. code § 34-18-10-13 (2020). 124. stafford, supra note 112 (discussing how the indiana court of appeals reinstated a medical malpractice claim from 2007 that was prolonged due to delays and discovery disputes and how the panel chair informed the case’s parties that deadlines would not be strictly enforced). 125. see eggen, supra note 1. 126. id. at 8. 127. william a. ramsey, dtci: the right to a meaningful medical review panel, ind. law. (sept. 18, 2019), https://www.theindianalawyer.com/articles/dtci-the-right-to-a-meaningfulmedical-review-panel [https://perma.cc/q3u4-a8ab]. 128. id. 129. allen k. hutkin, resolving the medical malpractice crisis: alternatives to litigation, 4 j.l. & health 21, 38 (1989). 130. eggen, supra note 1, at 22. 131. id.; but see chad terhune, top republicans say there’s a medical malpractice crisis. 2021] the constitutional strength of indiana’s medical review panel process 201 politically divided, with republicans more likely than democrats to believe there is a crisis.132 for this reason, republicans tend to be more in favor of medical review panel statutes.133 many believe that there are too many frivolous lawsuits that increase insurance premiums and are harming the businesses of doctors and other health care professionals.134 some have argued if doctors are afraid of too much litigation, they may order “excessive tests and treatments” which would increase the price of health care costs.135 high rates of litigation can also deter higher-risk specialists from practicing in certain states due to the increased probability they will be sued.136 additionally, even though there may be less of a malpractice crisis than years ago, that does not mean that one will arise again.137 however, researchers and experts on the other side of this debate, including many democrats, believe there is not a malpractice crisis in the country right now.138 they say this country has been free from this crisis for more than ten years.139 some on this side of the argument believe that reform measures, such as medical review panels, do not address the root of the problem: medical errors.140 in the last few years, studies have found that medical errors are the third leading cause of death in the united states.141 many on this side of the debate therefore argue that the best way to reduce litigation would be to address that problem first.142 as recent as 2017, a majority of republicans believed our country was still in the midst of a medical malpractice crisis.143 tort reform was vowed to be a large part of the replacement to the affordable care act.144 however, there are still groups that disagree.145 experts in the industry and researchers believe that the medical malpractice insurance industry in the united states is “running smoothly” and the country has not been in the middle of a malpractice crisis for experts say there isn’t, wash. post (dec. 30, 2016), https://www.washingtonpost.com/news/toyour-health/wp/2016/12/30/top-republicans-say-theres-a-medical-malpractice-crisis-experts-saythere-isnt [https://perma.cc/nf8c-pzbc]. 132. terhune, supra note 131. 133. id. 134. id. 135. id. 136. id. 137. see id. 138. id. 139. id. 140. id. 141. id. 142. id. 143. chad terhune, leading republicans see a costly malpractice crisis – experts don’t, kaiser health news (jan. 4, 2017), https://khn.org/news/leading-republicans-see-a-costlymalpractice-crisis-experts-don’t/ [https://perma.cc/vw7e-tnty]. 144. id. 145. id. 202 indiana health law review [vol. 18:189 over a decade.146 according to one of the nation’s largest malpractice insurers, doctors company, physicians were paying less for malpractice insurance in 2017 than they were in 2001 and the number of claims has “dropped by half since 2003.”147 in backing tort reforms, such as medical review panels, republicans argue that they are implemented with the goal of making it easier to defend against malpractice suits and raise the burden of proof for plaintiffs.148 in addition, republicans have been backing caps on damages, something that indiana implemented in the act.149 the republican plan to replace the affordable care act in 2017 looked to california and other states as examples to show that states that have tort reforms in this area experience an increase of doctors, an increase in access to specialists, and a reduction in medical liability insurance premiums.150 researchers that agree with the democratic side of this debate argue that damage caps are not the only factor that keeps insurance costs down; “economic cycles and insurers’ investment returns” are also factors that affect insurance costs.151 additionally, advocates for the democratic side of this argument state that republicans may be going too far and are reducing access to the justice system and preventing plaintiffs to recover fair compensation for actual medical mistakes.152 it is argued that the country should be focused on the bigger problem: reducing overall patient harm.153 the politics of tort reform could explain why some states are more likely to rule medical malpractice panels unconstitutional while others are upholding a very similar statute. in 1980 when it decided johnson, the majority of the indiana supreme court was appointed by a republican governor and remains that way today.154 conversely, a study done in 2016 found that the supreme court in kentucky tends to be much more liberal.155 kentucky has traditionally been a more democratic state, but in 2016, republicans gained control of the senate, the house of representatives, and the state had a republican governor.156 this political changeup occurred immediately before the medical review panel statute 146. id. 147. id. 148. id. 149. id.; see ind. code § 34-18-14-3 (2020). 150. terhune, supra note 143. 151. id. 152. id. 153. id. 154. see indiana supreme court, ballotpedia, https://ballotpedia.org/indiana_supreme_ court [https://perma.cc/dhr6-r7ky] (last visited oct. 30, 2019). 155. brian t. fitzpatrick, the ideological consequences of selection: a nationwide study of the methods of selecting judges, 70 vand. l. rev. 1729, 1742 (2017). 156. jack brammer & linda blackford, republicans take the kentucky house after 90 years of democratic control, lexington herald leader (nov. 8, 2016), https://www.kentucky. com/news/politics-government/article113464563.html [https://perma.cc/69pg-c9cn]. 2021] the constitutional strength of indiana’s medical review panel process 203 was introduced and passed.157 the vote in the kentucky senate to pass the medical review panel statute was very partisan.158 of the republicans that voted, all twenty-one of them voted yes to the passing of the bill.159 one democratic senator voted to pass the bill, while the other thirteen democrats voted no.160 kentucky is just one example of how important the members of a supreme court can be in implementing medical review panels. even though the bill passed the senate, it did not get past the kentucky supreme court. although indiana and kentucky have similar party control in the governor’s office and legislature at this time, the members of the supreme court are an important distinction that helps explain the difference in opinions of strikingly similar statutes. viii. alternatives to medical review panels with statutes similar to indiana’s medical malpractice act being struck down by courts and causing large delays, one can imagine that a challenge will be brought to the statute in the future. while the statute was ruled constitutional in 1980,161 the effects of the statute are very different today. when the act was enacted in 1975, only one complaint was filed.162 ten years later, a total of 4,225 complaints had been filed with only 1,171 resolved.163 as of 1983, complaints took 23.4 months to go through the panel process.164 in 2015 alone, the state saw one of the highest numbers of complaints filed with a total of 1,205.165 the number of complaints has lowered since 2015, with 987 in 2016 and 863 in 2017.166 however, with complaint numbers still high and a backlog in the courts, there are ways to improve the statute to ensure it is constitutionally strong in the face of a challenge. a. affidavit of merit approximately twenty-nine states use affidavits of merit in medical 157. see bruce schreiner, kentucky set to create medical malpractice claim review panels, insurance j. (mar. 20, 2017), https://www.insurancejournal.com/magazines/mag-features/2017/ 03/20/444684.htm [https://perma.cc/gp6t-pa2q]. 158. sb 119 establishes medical malpractice claims review panel voting record, vote smart, https://votesmart.org/bill/votes/46819#.xm_xsc3mwcg [https://perma.cc/u2w9-hsb9] (last visited mar. 16, 2020). 159. id. 160. id. 161. see johnson v. st. vincent hosp., 273 ind. 374 (1980). 162. kemper et al., supra note 9, at 1133. 163. id. 164. id. 165. ind. dep’t of ins., indiana patient’s compensation fund 2018 annual report 27 (2019), https://www.in.gov/idoi/files/2018%20combined%20annual%20report%20final.pdf [https://perma.cc/qkv9-acv5]. 166. id. 204 indiana health law review [vol. 18:189 malpractice claims.167 these affidavits are signed by a health care provider who attests to the merits of the malpractice claim.168 this product of tort reform is used to accomplish similar goals to that of medical review panels, including: (1) decreasing the number of suits filed; (2) decreasing the sum of money put aside for settling claims of uncertain value; (3) restricting the kinds and sums of liability insurance professionals must have; and (4) restricting the number and kinds of decisions made out of fear of a possible lawsuit.169 the hope is that the health care professional’s opinion, having signed the affidavit under oath, will reduce the number of frivolous medical malpractice claims filed.170 while many states require these affidavits with a claim of malpractice, the states differ as to the content of the affidavit and who can execute the same.171 generally, the attestations require the health care provider to state that he or she is “substantially familiar” with the applicable standard of care.172 states may require that the health care provider have experience in the field within a certain timeframe, such as within a certain number of years before the case, and some states allow professors of professional schools to qualify as well.173 the content of affidavits of merit varies from a simple statement after the relevant facts, such as “there is a ‘reasonable and meritorious cause’” for filing the claim, to the health care provider having to specifically “identify[] the departure from the relevant standard of care.”174 some states require the affidavit to state that the failure to meet the standard of care was the “proximate cause” of the injury.175 there are also states that require an attorney to sign the affidavit along with the health care provider.176 the attorney may need to “identify who they plan to call as expert witnesses should the matter go to trial, detail the facts and opinions the expert will testify to, and summarize the grounds for each opinion.”177 similar to an affidavit of merit, a “certificate of consultation” is used 167. christine funk, affidavits of merit in medical malpractice cases, expert inst. (jan. 25, 2018), https://www.theexpertinstitute.com/affidavits-merit-medical-malpractice-cases/ [https://perma.cc/35ay-c2x4]; see goldberg segalla llp, 50-state survey of affidavit of merit statutes, prof. liability matters, https://professionalliabilitymatters.com/wp-content/uploads/ 2015/02/gs-3471935-v3-pl_matters_aom_chart_revised.pdf [https://perma.cc/8a6j-gevu] (last updated feb. 2015). 168. see funk, supra note 167. 169. id. 170. id. 171. id. 172. id. 173. id. 174. id. 175. id. 176. id.; see, e.g., n.y. c.p.l.r. § 3012-a (mckinney 2020) (“in any action for medical . . . malpractice, the complaint shall be accompanied by a certificate, executed by the attorney for the plaintiff . . . .”). 177. funk, supra note 167. 2021] the constitutional strength of indiana’s medical review panel process 205 in some states.178 this certificate is filed by the plaintiff and provides the facts and the attorney’s consultation with at least one qualified health care provider.179 the purpose is to show that the attorney believes that there is a “valid basis” for filing the malpractice claim.180 while affidavits of merit are also an extra hurdle for plaintiffs to overcome before filing a lawsuit with the courts, they are a low-cost way to prevent frivolous claims.181 the cost of an affidavit of merit can be as low as $500 whereas the average cost of a medical review panel in indiana is approximately $3,000.182 in states where affidavits of merit are required for medical malpractice cases, the constitutionality of the statutes can be challenged similar to the challenges of medical review panels.183 arizona passed statutes requiring affidavits of merit in 2004 and has had multiple challenges to the statutes since their passing.184 the arizona courts have ultimately upheld the constitutionality of the statutes after access to the courts arguments, equal protection challenges, and separation of powers challenges.185 along with the low-cost of affidavits of merit, the shorter delay to court access is an advantage of this product of tort reform. referring to the length of medical review panels, the indiana trial lawyers association takes the view that the panels should not be mandatory if the plaintiff produces an affidavit of merit.186 this proposition could be beneficial in that it would allow plaintiffs to choose how to proceed. if they preferred to bring their claim to a medical review panel and try to obtain a favorable panel opinion, they would be allowed to do so. however, if they believe their best route is obtaining an affidavit of merit, they could choose that. obtaining an affidavit of merit requires some time, but it does not entail the same delays as medical review panels caused by selecting the panel chair, forming the panel, and extensions of deadlines by attorneys. additionally, the statutory deadlines for affidavits of merits are significantly shorter than those relating to medical review panels. for example, in indiana, the medical review panel should ideally render its opinion 180 days after the panel has been 178. id. 179. id. 180. id. 181. meryl j. thomas, the merits of procedure vs. substance: erie, iqbal, and affidavits of merit as medmal reform, 52 ariz. l. rev. 1135, 1140 (2010). 182. mary markle, how affidavit of merit requirements are ruining arizona’s medical liability system, 46 ariz. st. l.j. 407, 411 (2014); medical review panel, ind. dep’t ins., https://www.in.gov/idoi/2985.htm [https://perma.cc/5vzl-wsrb] (last visited feb. 1, 2020). 183. see markle, supra note 182. 184. id. at 409, 410. 185. id. at 410; see governale v. lieberman, 250 p.3d 220 (ariz. ct. app. 2011); see baker v. univ. physicians healthcare, 269 p.3d 1211 (ariz. ct. app. 2012); see seisinger v. siebel, 203 p.3d 483 (ariz. 2009); see jilly v. rayes, 209 p.3d 176 (ariz. ct. app. 2009). 186. stafford, supra note 112. 206 indiana health law review [vol. 18:189 formed.187 this does not take into account how long the panel formation process can take, and the average time of medical review panels shows that they often do not meet the 180-day deadline.188 in states that require affidavits of merit, the deadline is much shorter than 180 days.189 while the deadlines to file an affidavit of merit can range from the day the complaint is filed190 up to 180 days after the complaint has been filed,191 many states require the affidavit to be filed sixty or ninety days after the complaint has been filed.192 kentucky is an example of a state that has recently adopted affidavits of merit. after the kentucky supreme court ruled their medical malpractice statute unconstitutional in 2018, the state enacted new legislation that requires medical malpractice lawsuits be accompanied by a “certificate of merit.”193 the legislation requires a plaintiff to consult with at least one qualified expert who concludes that “there is a reasonable basis to commence the action.”194 the bill also contains some exceptions to the requirement.195 if a plaintiff does not have time to obtain a certificate and have an expert review the case before the statute of limitations runs, they may not need to obtain the certificate.196 additionally, if a plaintiff has “made at least three . . . separate good-faith attempts” with different experts who do not agree to consult on the case, the requirement may be waived if none of the experts contacted “gave an opinion that there was no reasonable basis to commence the action.”197 lastly, the certificate is not required if the plaintiff is relying “solely on one . . . or more causes of action for which expert testimony is not required.”198 187. ind. code § 34-18-10-13 (2020). 188. see eggen, supra note 1, at 27. 189. state laws chart ii: liability reform, ama, https://www.ama-assn.org/sites/amaassn.org/files/corp/media-browser/premium/arc/state-laws-chart-2_0.pdf [https://perma.cc/r7rvuut4] (last updated sept. 2017). 190. see ariz. rev. stat. ann. § 12-2603 (2020); see conn. gen. stat. § 52-190a (2020); see del. code ann. tit. 18, § 6853 (2020); see fla. stat. § 766.104 (2020); see ga. code ann. § 9-11-9.1 (2020). 191. see minn. stat. § 145.682 (2020). 192. see goldberg segalla llp, supra note 167; see colo. rev. stat. § 13-20-602 (2020); see md. code ann., health-gen. § 3-2a-04 (west 2020); see n.j. stat. ann. § 2a:53a-27 (west 2020); see n.y. c.p.l.r. § 3012-a (mckinney 2020); see tenn. code ann. § 29-26-122 (west 2020). 193. ky. rev. stat. ann. § 411.167 (west 2020); al cross, bill on bevin’s desk would require a malpractice lawsuit to certify that an expert has said it has a reasonable basis to be filed, ky. health news (mar. 22, 2019), http://ci.uky.edu/kentuckyhealthnews/2019/03/ 22/bill-on-bevins-desk-would-require-a-malpractice-lawsuit-to-certify-that-an-expert-has-said-ithas-a-reasonable-basis-to-be-filed/ [https://perma.cc/mmq7-qvj4]. 194. § 411.167. 195. see id.; see also cross, supra note 193. 196. § 411.167; cross, supra note 193. 197. § 411.167. 198. id. 2021] the constitutional strength of indiana’s medical review panel process 207 b. arbitration and mediation other alternatives to medical review panels are binding arbitration and mediation. binding arbitration differs from medical review panels in that there are currently no states that require binding arbitration in medical malpractice cases.199 arbitration can be chosen by the parties through private contracts and some states have legislation that authorizes this kind of agreement.200 the agreements are usually presented to the patient either when they are being admitted to receive treatment, or before they are able to receive treatment.201 arbitration is similar to medical review panels in that one of the goals is to reduce the cost of medical malpractice litigation.202 however, also similar to medical review panels, the goal of reducing costs may not be working the way it was hoped.203 arbitration, unlike other tort reform alternatives, does not attempt to encourage the early settlement of cases.204 this process gives the power to the arbitrator to determine whether or not “a standard of care was met.”205 the arbitrator can then “assign[] fault, and award damages in compensation.”206 the goals for binding arbitration in medical malpractice cases are greater efficiency and “reduced medical liability system costs,” but it is possible that these goals are not being met.207 one study has found that insurance premiums actually went up in states that permitted binding arbitration, while another study found that areas with arbitration correlated with an increased frequency of claims being filed and paid.208 included in these are small claims that are unlikely to proceed to court due to the costs.209 while some support arbitration, it seems there is a good reason that this form of tort reform is not very common.210 there may not be an incentive for states to use binding arbitration because it is likely not going to be the most favorable tort reform option for either party.211 199. nussbaum, supra note 11, at 272. 200. id. at 274. 201. alba reyes santos, medical malpractice arbitration agreements: is uniformity the solution?, hous. j. health l. & pol’y 1, http://www.law.uh.edu/healthlaw/perspectives/2012/ alba%20reyes%20santos--med%20mal%20arbitration.pdf [https://perma.cc/8p6u-vrfw] (last visited mar. 24, 2020). 202. nussbaum, supra note 11, at 276. 203. id. 204. id. at 273. 205. id. 206. id. 207. id. at 276. 208. id. 209. id. 210. id. 211. alex stein, the incentives to arbitrate medical malpractice disputes, bill health (aug. 29, 2013), https://blog.petrieflom.law.harvard.edu/2013/08/29/the-incentives-to-arbitrate208 indiana health law review [vol. 18:189 whether or not arbitration is used usually depends on whether or not the health care provider chooses to include an arbitration clause in the contract that is signed by the patient.212 arbitration agreements need to be knowingly and voluntarily signed by the patient, which means that their attention should be drawn to the arbitration agreement before they sign.213 for patients, this could create some uncertainty.214 if patients believe that their doctor is trying to ensure they do not take the normal litigation route, patients could become suspicious and wonder whether the normal litigation route would be more beneficial to them.215 doctorpatient relationships are important and doctors may not want to hurt this relationship by fostering suspicion in their patients before they are even treated.216 there are also many cases in which patients “argue that they did not knowingly waive their right to trial by jury and that they did not understand or know what they were signing.”217 if this is true, a patient will not be bound by the arbitration clause.218 patients may also believe that they would receive a larger award if they went before a jury.219 medical malpractice claims can be emotional, which could lead patients to want to litigate before a jury and provide them with the emotional, compelling arguments for their case.220 although arbitration may not be ideal for patients or doctors, there have been federal and state attempts to promote arbitration agreements. in 1925, the federal arbitration act (“faa”) was enacted with two purposes: (1) “to end the feeling of animosity towards arbitration,” and (2) “to make courts enforce arbitration agreements involving interstate commerce and maritime transactions.”221 when the faa applies, state laws regarding arbitration are preempted by the federal statute.222 thirty years after the faa was passed, the national conference of commissioners on uniform state laws published the uniform arbitration act (“uaa”) that was created to “offer[] the states arbitration mechanisms that are more versatile than the faa.”223 even with these attempts to regulate arbitration among the states, many states have adopted their own tort reforms, creating different standards and requirements for claims.224 with so many different standards for arbitration across the united states, there can be questions about whether or not arbitration will be enforced by the courts in differing states, and medical-malpractice-disputes/ [https://perma.cc/ej3b-2yau] 212. id. 213. id. 214. see id. 215. id. 216. id. 217. santos, supra note 201, at 6. 218. stein, supra note 211. 219. santos, supra note 201, at 6. 220. id. 221. id. at 7. 222. id. at 8. 223. id. 224. id. https://perma.cc/ej3b-2yau 2021] the constitutional strength of indiana’s medical review panel process 209 whether or not patients will feel comfortable entering these agreements.225 these questions could be factors that are deterring the use of arbitration in these cases.226 mediation can also serve as an alternative tort reform process that could reduce the timing and costs of other alternatives such as medical review panels.227 different from both medical review panels and binding arbitration, mediation serves to be a voluntary, informal negotiation that can also attempt to address communication between health care providers and patients.228 in a mediation, “a neutral third person . . . helps the parties” in a dispute negotiate an acceptable resolution.229 the confidentiality of discussions in mediations can encourage parties to explain to each other what went wrong and defendants can make “benevolent gestures without fear these actions will later be used in court.”230 mediation is less expensive for courts and uses fewer court resources than medical review panels.231 as with all tort reforms, there are benefits and disadvantages to mediation. some benefits of mediation include the ability to have more control over the resolution of the case, the ability to schedule a mediation as soon as the parties agree to mediation, and voluntary settlement of the case.232 additionally, mediation can “promote better relationships through cooperation, creative problem-solving, and improved communications.”233 mediation can also be beneficial because the parties are creating a settlement agreement themselves so they are more like to abide by the agreement.234 some may view mediation as unfavorable for their case because they would rather have their case decided by a judge or jury.235 mediation might not always be the most effective way of settling a case if it is early on and the parties do not have sufficient information about each other’s competing arguments.236 further, if there is no settlement reached at the mediation, then time and money have been spent on alternate dispute resolution and the case will have to continue to trial anyway.237 225. see id. 226. see id. at 8-9. 227. see nussbaum, supra note 11, at 277. 228. mediation, a.b.a., https://www.americanbar.org/groups/dispute_resolution/resources/ disputeresolutionprocesses/mediation/ [https://perma.cc/6e3g-2bcz] (last visited nov. 29, 2020). 229. steven gosset, mediation can help resolve malpractice lawsuits, study finds, but doctors, lawyers remain wary, pr web (dec. 13, 2010), https://www.prweb.com/releases/2010/ 12/prweb4892554.htm [https://perma.cc/797z-jptu]. 230. nussbaum, supra note 11, at 279 (footnote omitted). 231. id. 232. mediation/alternative dispute resolution, ind. jud. branch, https://www.in.gov/ judiciary/selfservice/2360.htm [https://perma.cc/uv2x-7q7m] (last visited mar. 24, 2020). 233. id. 234. id. 235. id. 236. id. 237. id. 210 indiana health law review [vol. 18:189 even though mediation has some benefits, the disadvantages seen by doctors, hospitals, and lawyers may prevent mediation from becoming widely used in medical malpractice cases.238 a study found that when mediation was used, benefits of the practice included reduced costs of litigation and “the potential to offer closure to plaintiffs and ensure that procedures are changed in hospitals to prevent recurrences of the error that sparked the lawsuit.”239 the study looked at “[thirty-one] cases from [eleven] nonprofit hospitals in new york city in 2006 and 2007 that went to mediation.”240 around 70$ of the cases studied settled during or after mediation.241 the settlement amounts ranged from “$35,000 to $1.7 million.”242 even with the benefits of mediation, the study recognized challenges that may not lead many cases to take advantage of mediation.243 the study found that a major challenge of mediating medical malpractice cases is the absence of doctors at the mediations.244 the authors of the study viewed this as an issue because “it is possible that plaintiffs would have been even more satisfied with the process had their physicians demonstrated respect and caring” by taking the time to attend and participate in the process.245 attorneys for the defendants and physicians provided some reasons for the absence of individual physicians in the mediations.246 for some, it was their work schedule.247 for others, the attorneys did not want the doctors to be “verbally attacked by the plaintiff.”248 there has also been research that although patients “expect an apology after a medical error,” most doctors do not do apologize out of fear that it will lead to legal liability.249 if physicians attended the mediations, not only are they reducing their ability to learn from the mistakes and improve the quality of their care but the plaintiff may not be as satisfied with the process as they could have been had the physician been present.250 mediations are confidential and what is discussed is not admissible in court.251 this should lead the parties to be open and honest about the case and gives the physicians and health care networks the ability to learn from a mistake and make any changes they see could benefit the system in the future.252 while there are certainly benefits to mediation, it is difficult to assess how 238. gosset, supra note 229. 239. id. 240. id. 241. id. 242. id. 243. id. 244. id. 245. id. 246. id. 247. id. 248. id. 249. id. 250. id. 251. id. 252. id. 2021] the constitutional strength of indiana’s medical review panel process 211 successful mediation can be.253 while cases may settle during mediation, cases also may settle after mediation as a result of the negotiations or conversations that occurred at mediation.254 mediations have the potential to be very helpful in settling medical malpractice cases, but if that potential is not realized by the parties, it will be difficult to require everyone involved to agree to this resolution option. c. intentional delay remedies a more efficient panel process would be created by enacting stringent deadlines and providing remedies to plaintiffs should the process go beyond those deadlines. extreme time delays are caused when attorneys do not want deadlines enforced, and panel chairs are not consistently enforcing deadlines.255 although the statute contains sufficient remedies for delay, if attorneys do not turn to the courts to enforce them, the remedies remain dormant.256 the attorneys in the chairman position are vested with the duties to “expedite the selection of the other panel members” and “expedite the panel’s review of the proposed complaint.”257 these responsibilities should include providing reasonable deadlines to the parties and making sure the deadlines are being met. monetary sanctions could be imposed if the deadlines are not met. alternatively, significant delays in the panel process could allow the plaintiff to proceed directly to court and bypass the rest of the panel process. d. apology statutes the high rate of medical malpractice claims can sometimes be caused by a strained or distant relationship between a patient and a doctor.258 in an effort to change this relationship, a majority of states, including indiana, have enacted “apology statutes.”259 these statutes are aimed at reducing medical malpractice claims, liability, and litigation expenses.260 the hope is that an apology will reduce the patient’s frustration and anger after feeling that their physician has not met the standard of care. a study found that physicians and hospital staff that are “willing to discuss, apologize for and resolve adverse medical events through a ‘collaborative communication resolution program’” experience a decrease in the 253. nussbaum, supra note 11, at 280-81. 254. id. 255. stafford, supra note 112. 256. id.; see ind. code § 34-18-10-14 (2020). 257. ind. code § 34-18-10-3 (2020). 258. see bowen, supra note 13. 259. bonnie g. ackerman, you had me at “i’m sorry”: the impact of physicians’ apologies on medical malpractice litigation, nat’l l. rev. (nov. 6, 2018), https://www.natlawreview. com/article/you-had-me-i-m-sorry-impact-physicians-apologies-medical-malpractice-litigation [https://perma.cc/m9k6-n6fv]. 260. id. 212 indiana health law review [vol. 18:189 number of legal claims filed against them, time spent on resolving cases, and litigation costs.261 the apology statute in indiana provides that a court cannot admit into evidence “a communication of sympathy that relates to causing or contributing to: (1) a loss; (2) an injury; (3) pain; (4) suffering; (5) a death; or (6) damage to property.”262 while improved relationships and more transparency between physician and patient may reduce the number of malpractice claims, a fear that the apology may appear to be a statement of fault can prevent physicians from using the provisions in these statutes.263 although this fear exists, studies have shown that apologies can reduce the cost of litigation while allowing physicians to exhibit their humanity and provide closure to patients and patients’ family members.264 even in states that already have apology statutes, it is important that health care providers are aware of the statute in their state and know the benefits that could come from a simple apology to “soothe the feelings of a patient or family” and keep a doctor-patient relationship strong.265 ix. conclusion while the supreme court of indiana has held that the medical malpractice act is constitutional, the court’s reliance on the premise of a reasonable delay to the courts could result in a challenge brought in the future. the delay to plaintiffs’ access to the courts could be lessened if the overall time the panel process takes is reduced, thereby strengthening the likelihood that the act will continue to be upheld as constitutional. the presence of a medical malpractice crisis in the country and the constitutionality of tort reform efforts may be divided politically, but attempts to make the process fair and timely should be an important goal for all parties involved. many tort reform efforts in place today result in at least some extra delay and cost in contrast to going straight to court. however, some options may be better than others. in indiana, the extreme delay that is currently placed on plaintiffs’ cases in the medical review panel process is a problem that should be addressed. if the deadlines in the medical malpractice act pertaining to the medical review panels were enforced, the delay would be considerably lessened. this would require the panel chair to establish and enforce the deadlines, and attorneys should also be encouraged to turn to the courts for relief if a party is not complying. alternatively, a new reform measure should be considered. allowing plaintiffs to avoid the medical review panel process with an affidavit of merit that would likely decrease the delay while also accomplishing the goal of reducing the number of frivolous claims. although the indiana supreme court has previously 261. id. 262. ind. code § 34-43.5-1-4 (2020). 263. nicole saitta & samuel d. hodge, jr., efficacy of a physician’s words of empathy: an overview of state apology laws, 112 j. am. osteopathic ass’n 302, 302 (2012). 264. id. at 303. 265. id. at 306. 2021] the constitutional strength of indiana’s medical review panel process 213 ruled the panel process constitutional, there is a stark difference in the time of delay now compared to in the past, and the delay may not be considered reasonable anymore. whether or not there is a malpractice crisis in the united states, a multi-year delay of access to the court system, a constitutional provision no less, is a problem worth reconsidering. the beginning and end of our analysis: the seventh circuit’s approach to the three-way circuit split of dismissal authority in qui tam claims* wm. luke mcnamee** i. introduction a. the issue: the three-way circuit split over the government’s authority to dismiss whistleblower claims under the false claims act when the united states government introduces massive spending packages in response to a crisis, fraudsters are inevitably lurking in the wings to avail themselves of the taxpayer’s money. recognizing this, congress reinvigorated the provisions of the false claims act (“fca”) during the late 1980s to allow the federal government broader authority to pursue entities guilty of fraudulent acts. the sums of money claimed by fraudsters and subsequently reclaimed by the federal government and the whistleblowers who come forward with information are staggering. in fact, in 2019 alone the federal government recovered approximately $3 billion from fraudulent claims, more than $2.1 billion of which were under the qui tam provisions of the fca. of that $2.1 billion, whistleblowers who exposed the fraudulent payments received $265 million. the massive government expenditures in response to the covid-19 pandemic present another opportunity for rampant fraud. over the course of the pandemic, congress has provided for about $6 trillion in economic relief.1 most recently, president biden signed the american rescue plan act, which provided $1.9 trillion. this is in addition to the $2.2 trillion of relief provided when president trump signed the coronavirus aid, relief, and economic security (cares) act.2 as of august 2020, more than 5.2 million loans valued at $525 billion were approved by the small business administration.3 this represents a massive pool of federal funds ripe for fraudulent behavior and for whistleblowers * this note was completed in march 2021. ** j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.a., 2014, ball state university. 1. garrett watson & erica york, the american rescue plan act greatly expands benefits through the tax code in 2021, tax found. (mar. 12, 2021), https://taxfoundation.org/americanrescue-plan-covid-relief/ [https://perma.cc/x8k4-xbud]. 2. sean bosack & nina beck, qui tam actions: managing risk in the wake of covid-19, a.b.a. (sept. 1, 2020), https://www.americanbar.org/groups/litigation/committees/corporatecounsel/articles/2020/summer2020-qui-tam-actions-managing-risk-in-the-wake-of-covid-19 [https://perma.cc/3dxm-p3h2]. 3. press release, acting assistant att’y gen. brian rabbitt, acting assistant att’y gen. brian rabbitt delivers remarks at the ppp criminal fraud enf’t action press conference (sept. 10, 2020), https://www.justice.gov/opa/speech/acting-assistant-attorney-general-brian-rabbittdelivers-remarks-ppp-criminal-fraud [https://perma.cc/rx54-t8en]. 192 indiana health law review [vol. 19:191 to share in recovering under the qui tam provisions of the fca. such provisions create opportunities for massive windfalls for whistleblowers and ample opportunity for federal regulators to recover enormous sums of taxpayer money. the fca is a critical tool in the united states government’s ongoing effort to combat fraud. the fca provides that any person who knowingly submits a false claim for payment is liable to the federal government for civil penalties plus treble damages.4 to assist the government in ferreting out fraudsters, the fca empowers private citizen whistleblowers, referred to as “relators,” to file suit “for the person and for the united states government” and awards them part of the recovery as an incentive to come forward.5 but, like all good things, there is a catch: while the relator may initiate the suit, the government retains the authority to dismiss the claim.6 the proper standard for dismissal by the government, however, is unclear. three united states circuit courts of appeal have adopted three separate standards for determining the scope of federal regulators’ authority to dismiss claims initially filed by whistleblowers per the qui tam provisions of the fca. the differing approaches arise from the lack of an explicit statutory standard of dismissal. the fca was most recently amended in 1986, when senator chuck grassley pushed to strengthen the qui tam provisions in response to rampant fraud.7 the amendments have increased the number of qui tam suits filed, as senator grassley intended, but have also given rise to three separate circuit interpretations of the proper standard for dismissal. the first attempt to articulate a standard came from the ninth circuit in 1998 in sequoia orange co. v. baird neece packing corp.8 in sequoia orange, the ninth circuit required the government to demonstrate a ‘rational basis’ for its motion to dismiss a relator’s claim.9 five years later, the district of columbia circuit adopted a standard granting greater discretion to government regulators in swift v. united states.10 there, the d.c. circuit held the government had an “unfettered right” to dismiss such claims, since whistleblowers brought them on behalf of the government to begin with.11 this two-way circuit split persisted for nearly 20 years until 2020, when the seventh circuit adopted its own standard. in united states ex rel. cimznhca, llc, v. ucb, inc., the seventh circuit came up with a third standard based on the federal rules of civil procedure.12 4. false claims act, 31 u.s.c. §§ 3729–3733. 5. 31 u.s.c. § 3730(d). 6. 31 u.s.c. § 3730(c)(2)(a). 7. s. rep. no. 99-345, at 13 (1986). 8. see generally united states ex rel. sequoia orange co. v. baird-neece packing corp., 151 f.3d 1139 (9th cir. 1998). 9. see id. 10. see swift v. united states, 318 f.3d 250 (d.c. cir. 2003). 11. id. at 252. 12. see united states ex rel. cimznhca, llc, v. ucb, inc., 970 f.3d 835 (7th cir. 2020). 2022] the beginning and end of our analysis 193 in the following pages, this note will discuss each of these standards and assert that the supreme court should settle the circuit split by adopting the recent seventh circuit standard. this note will be divided into three major sections. the first section will provide historical background on qui tam actions and the fca, an explanation of the fca statutory provisions, and insights into the legislative history. the second section will provide an overview and analysis of each circuit’s decision and key reasoning. finally, the third section will provide a critical analysis of the varying standards and a justification as to why the supreme court should adopt the seventh circuit’s holding in cimznhca. ii. background a. history of the false claims act a “qui tam” action is one brought by a private party on behalf of the government. the term is shorthand for a latin phrase meaning “who as well for the lord king as for himself sues in this matter.”13 the concept of qui tam actions has been around since the days of the roman empire.14 interestingly, one of the earliest cited examples of a qui tam provision is found in english law. in the year 695, a declaration of king wihtred of kent stated that “[i]f a freeman works during the forbidden time [i.e., the sabbath], he shall forfeit his healsfang, and the man who informs against him shall have half the fine, and [the profits arising] from the labour.”15 qui tam provisions were also codified by several american colonies prior to the american revolution.16 colonial courts heard qui tam cases arising under both colonial and english statutes.17 the fca itself was originally codified in 1863 in response to rampant fraud by defense contractors during the civil war against the union army.18 as enacted, civilian offenders could be imprisoned or fined between $1,000 and $5,000, and faced civil liability in the amount of $2,000, double the damages sustained by the government, plus costs.19 recognizing public officials were often parties to the corruption and unlikely to diligently pursue war contractors engaged in fraud, congress sought to incentivize private citizens who possessed knowledge of fraud to come forward.20 the original law, reminiscent of the modern statute, entitled whistleblowers to one-half of the damages awarded from a successful suit as an incentive to collaborate with the federal government.21 13. id. at 839. 14. richard a. bales, a constitutional defense of qui tam, 2001 wis. l. rev. 381, 387. 15. charles doyle, qui tam: the false claims act and related federal statutes, cong. rsch. serv., apr. 2021, at 1, 2. 16. bales, supra note 14, at 387. 17. doyle, supra note 15, at 3. 18. bales, supra note 14, at 388. 19. doyle, supra note 15, at 5. 20. bales, supra note 14, at 388. 21. id. 194 indiana health law review [vol. 19:191 however, the qui tam provisions of the law were not widely used until the 1930s when federal expenditures increased as a result of massive domestic and wartime spending.22 the new deal and world war ii expanded the federal government’s role in the economy, creating opportunity for contractors to defraud the government and for savvy whistleblowers to file opportunistic “parasitic” suits, which contravened the public policy motives behind qui tam actions.23 seeking to curtail this practice, congress amended the fca in 1943 to bar qui tam suits based on public information and significantly reduced the reward amount for whistleblowers.24 as amended in 1943, the law required relators to provide the government with evidence underlying the claim and allow the government sixty days to intervene.25 it also precluded suits based on evidence already known to the government and reduced the relator’s share of the recovery from 50% to no more than 25%.26 while successful at reducing the number of lawsuits, these changes effectively eliminated the use of fca qui tam actions.27 the fca remained dormant until increased government spending arising from the cold war in the 1980s saw increased reports of systematic fraud. in 1986, the u.s. department of justice (“doj”) estimated that fraud drained “1 to 10 percent of the entire federal budget,” placing the potential fraud against the government between $10 to $100 billion annually.28 in response to these reports, senator chuck grassley and federal lawmakers introduced and later codified the false claims reform act in 1986 (referred to hereafter as the 1986 amendments).29 among the goals of the legislation was to once again foster private citizen involvement in whistleblower suits as relators, as well as to increase the percentage of the judgment the relator may be entitled to receive.30 b. how qui tam works the current version of the fca, reinvigorated by the 1986 amendments, provides that any person who knowingly presents a false or fraudulent claim for payment or approval to the united states government is liable for a civil penalty of up to $10,000 plus “3 times the amount of damages which the government sustains because of the act of that person.”31 more importantly, the qui tam 22. bales, supra note 14, at 389. 23. id. prior to 1943, the fca allowed “parasitic” qui tam suits based on public information. this permitted “informers” to abuse the statute by filing qui tam claims based on the information in public criminal indictments. these suits undermined the purpose of the fca. 24. id. 25. 57 stat. at 608, 31 u.s.c. ch. 232(c) (1946). 26. id. 27. bales, supra note 14, at 389. 28. s. rep. no. 99-345, at 3 (1986). 29. id. at 13. 30. id. at 8. 31. 31 u.s.c. § 3729(a). 2022] the beginning and end of our analysis 195 provisions of the fca allow a private individual, called a “relator,” to file an action on behalf of themself and the federal government against an individual or company who has knowingly submitted a false claim to the government for payment.32 relators may file an action under seal and serve a copy of the complaint on the government sixty days before it is served on the defendant.33 during that sixty-day period, which may be extended by motion, the government can investigate the allegations and either: (a) “proceed with the action, in which case the action shall be conducted by the government”; or (b) decline to take over the action.34 if the government declines to take over the action, the relator retains the right to proceed with the lawsuit.35 in exchange for coming forward, a successful relator will generally receive a share of the recovery.36 the amount of recovery varies between 15 to 25 percent for actions in which the government is involved, and 25 to 30 percent if the government declines to become involved.37 the two most important provisions of the fca for purposes of this note are 31 u.s.c § 3730(c)(2)(a) and 31 u.s.c. § 3730(c)(3). section 3730(c)(2)(a) allows the government to “dismiss the action notwithstanding the objections of the person initiating the action if the person has been notified by the government” and if the court provides the person with “an opportunity for a hearing on the motion.”38 the latter section, § 3730(c)(3), permits the government—which may have initially declined to take over the case—”to intervene at a later date upon a showing of good cause.”39 as will be discussed in greater detail below, the now three-way circuit court split arises out of the standard for dismissal in § 3730(c)(2)(a). iii. dismissal standards a. the sequoia orange “rational relation” test although the updated version of the statute had been in effect for more than five years, the proper standard for the government’s motion to dismiss under 31 u.s.c. § 3730(c)(2)(a) was a case of first impression for the united states district court for the eastern district of california.40 in sequoia orange, the corporate relator filed qui tam actions against thirty-four other companies in the citrus industry alleging violations of a particular marketing order promulgated by 32. 31 u.s.c. § 3730(b). 33. 31 u.s.c. § 3730(b)(2). 34. 31 u.s.c. § 3730(b)(4). 35. 31 u.s.c. § 3730(b)(4)(b). 36. 31 u.s.c. § 3730(d). 37. id. 38. 31 u.s.c. § 3730(c)(2)(a). 39. 31 u.s.c. § 3730(c)(3). 40. united states ex rel. sequoia orange co. v. sunland packing house co., 912 f. supp. 1325, 1328 (e.d. cal. 1995). 196 indiana health law review [vol. 19:191 the secretary of agriculture.41 the marketing order was promulgated under the agricultural marketing agreement act (“amaa”) of 1937, which was enacted “to establish and maintain [. . .] orderly marketing conditions for agricultural commodities in interstate commerce.”42 the goal of the legislation is to create a “cooperative venture among the secretary, handlers, and producers [. . .] to establish an orderly system for marketing [fruits and vegetables].”43 the amaa does not require the secretary to promulgate any marketing orders unless the industry participants request assistance obtaining one.44 furthermore, marketing orders must be approved and implemented by the industry stakeholders unless the secretary waives the necessary approval.45 sunkist, an agricultural cooperative, used its large market share to perpetuate weekly volume caps for the entire industry.46 meanwhile, sunkist and the rest of the industry, including sequoia orange co., allegedly violated the weekly caps as a matter of course.47 when sequoia orange co. was sanctioned by the united states department of agriculture (“usda”) for violation of the amaa, it filed numerous fca suits against sunkist and other independent growers.48 the government initially only intervened in ten of the cases, but later sought to intervene in the remaining twenty-four as part of an effort to settle years of negotiations with the citrus industry regarding the marketing order, which was ultimately invalidated in a separate suit.49 after the marketing order was invalidated, the government wanted to “wipe the slate clean” with members of the citrus industry, but apparently did not believe it had the authority to dismiss qui tam actions over the objection of the relator.50 in fact, the associate general counsel to the usda at the time, john golden, testified during evidentiary proceedings that “the department was of the view that some independent legal basis had to be adduced in order to seek dismissal of these cases and that [§ 3730] (c)(2)(a) provided an opportunity for the government to seek to dismiss the cases if there was some other independent legal basis to do so.”51 however, it moved to do so after seeking advice from the defendant corporation.52 41. united states ex rel. sequoia orange co. v. baird-neece packing corp., 151 f.3d 1139, 1142 (9th cir. 1998). 42. sunland packing house, 912 f. supp. at 1329. 43. id. (citing block v. community nutrition inst. 467 u.s. 340, 346 (1984)). 44. id. 45. id. 46. id. at 1330. 47. id. 48. id. at 1331. 49. id. see also united states v. sunny cove citrus ass’n, 854 f. supp. 669, 697 (e.d. cal. 1994). 50. united states ex rel. sequoia orange co. v. baird-neece packing corp., 151 f.3d 1139, 1142 (9th cir. 1998). 51. sunland packing house co., 912 f. supp. at 1338. 52. sequoia orange co., 151 f.3d at 1142; see also sunland packing house co., 912 f. supp. at 1352. as golden stated, the usda was simply unaware of its ability to dismiss qui tam 2022] the beginning and end of our analysis 197 the district court granted the government’s motion to dismiss all thirty-four actions on a finding that the government sought dismissal “for legitimate government purposes; that the reasons offered by the government were rationally related to these legitimate government purposes; and that the dismissal was not arbitrary or capricious.”53 on appeal, the relator argued that allowing the government to dismiss meritorious qui tam claims was inconsistent with the general framework of the fca.54 the ninth circuit ultimately disagreed, citing the relatively new dismissal authority under 31 u.s.c. § 3730(c)(2)(a), which allowed the government to dismiss actions “notwithstanding the objections of the relator.”55 the ninth circuit went on to consider the legislative history of the 1986 amendments to the fca. relying on the senate report as evidence of congressional intent, the court believed the 1986 amendments provide “qui tam plaintiffs with a more direct role [. . .] in acting as a check that the government does not neglect evidence, cause undue delay, or drop the false claims case without legitimate reason.”56 these statements were evidence of congressional intent that the qui tam statute permitted a limited check on prosecutorial discretion. thus, the ninth circuit continued, the district court’s two-step test of “rationally related to a legitimate government interest” satisfies congressional intent with regard to relators, while respecting the government’s prosecutorial authority by requiring the same justification for dismissal motions as mandated by the constitution itself.57 the relators in sequoia orange also argued that, even if the government could dismiss the action, it could not do so after intervening later for good cause under 31 u.s.c. § 3730(c)(3). the ninth circuit also dismissed this contention, citing precedent in united states ex rel. kelly v. boeing co., that nothing in § 3739(c)(2)(a) purported to limit the government’s dismissal authority based on the manner of intervention.58 in fact, kelly also permitted the government to dismiss qui tam actions without actually intervening.59 recognizing the government’s ability to dismiss the action without intervening, the court quickly actions under 31 u.s.c § 3730(c)(2)(a) until attorneys for defendant fruit company, sunkist, informed them of the provision. once the usda became aware of this provision, they no longer desired to simply remove themselves from the case, but rather to “dismiss all of the litigation that [the usda] possibly could.” id. the usda believed this was the most effective way to advance settlement negotiations related to a decade long dispute in the citrus industry over a burdensome marketing order that was regularly violated by those subject to it. 53. sequoia orange co., 151 f.3d at 1139 (citing sunland packing house co., 912 f. supp. at 1325). 54. id. at 1143. 55. id. at 1144. 56. id. (citing s. rep. no. 99-345, at 25-26 (1986)). 57. id. at 1146 (citing united states v. redondo-lemos, 955 f.2d 1296, 1298-99 (9th cir. 1992)) (holding due process prohibits arbitrary or irrational prosecutorial decisions). 58. id. at 1145 (citing united states ex rel. kelly v. boeing co., 9 f.3d 743 (9th cir. 1993)). 59. id. 198 indiana health law review [vol. 19:191 dispensed with the relator’s contention that the applicable standard governing the motion to dismiss was federal rule of civil procedure 41(a)(2).60 rule 41(a)(2) allows courts to grant a plaintiff’s motion to dismiss only by court order on terms the court considers proper and grants the dismissal without prejudice unless the court states otherwise.61 under this theory, the relator in sequoia orange sought protection from prejudice resulting from the government’s motion to dismiss.62 however, the ninth circuit agreed with the lower court’s determination that since voluntary dismissal by the government is explicitly authorized by the fca, the specific language of the act controlled where the two were inconsistent.63 in summary, the ninth circuit in sequoia orange concluded that 31 u.s.c § 3730(c)(2)(a) permits the government to dismiss a meritorious qui tam action where the government offers reasons for dismissal that are “rationally related to a legitimate government interest.”64 it also rejected the plaintiff’s contention that the government could not move to dismiss the action without first moving to intervene.65 b. swift’s “unfettered discretion” in swift v. united states, a former doj employee brought a qui tam action against other employees of the doj for submitting allegedly fraudulent time sheets.66 the government moved to dismiss the complaint without purporting to intervene, arguing the amount of money involved did not justify the expense of litigation.67 after the lower court granted the motion to dismiss, the relator appealed on the grounds that, among other reasons, the government cannot move to dismiss without first intervening and that it did not justify its decision to dismiss the claim.68 the d.c. circuit noted the language of 31 u.s.c. § 3730(c)(2)(a) does not explicitly require the government to intervene to seek dismissal.69 rather, the fca allows the government the binary option to intervene or not intervene, and makes intervention necessary only if the government “proceed[s] with the action.”70 in other words, intervention is necessarily only when the case goes forward with the government running the litigation.71 thus, ending the action by 60. id. 61. fed r. civ. p. 41(a)(2). 62. sequoia orange co., 151 f.3d at 1145. 63. united states ex rel. sequoia v. sunland packing house co., 912 f. supp. 1325, 1338 (e.d. cal. 1995). 64. sequoia orange co., 151 f.3d at 1147. 65. sunland packing house co., 912 f. supp. at 1338. 66. swift v. united states, 318 f.3d 250, 250 (d.c. cir. 2003). 67. id. at 251. 68. id. 69. id. 70. id. 71. id. 2022] the beginning and end of our analysis 199 dismissal under section 3730(c)(2)(a) is not proceeding with the action and, therefore, does not require intervention. the court also pointed out that, even if intervention were required, the court would “construe the government’s motion to dismiss as including a motion to intervene.”72 ultimately, the d.c. circuit declined to adopt the ninth circuit’s standard in sequoia orange, holding instead that the government possesses the “unfettered right” to dismiss qui tam claims and that such decisions are not subject to judicial review.73 the d.c. circuit departed from the ninth circuit’s approach for several reasons. first, the absence of affirmative language granting judicial oversight of the decisions to dismiss “at least suggests the absence of judicial constraint.”74 additionally, since the government’s decision to dismiss the case is, in essence, a decision not to prosecute, united states supreme court precedent in heckler v. chaney, maintains that executive branch decisions not to prosecute are unreviewable.75 finally, federal rule of civil procedure 41(a)(1)(i) permits a plaintiff to dismiss an action “without order of the court” if the adverse party has not filed an answer or motion for summary judgment. since qui tam actions remain under seal for at least sixty days as a matter of procedure, government dismissal in that period necessarily occurs before the defendant can file an answer.76 therefore, because dismissals under rule 41(a)(1)(i) are not subject to judicial review, neither should government motions to dismiss filed during the same period.77 it also disagreed with the ninth circuit’s position that the relator’s right to a hearing provided by 31 u.s.c § 3730(c)(2)(a) justified its rational relation test. relying on heckler v. chaney and the “take care clause” of the constitution, the d.c. circuit reiterated that the decision whether to bring an action on behalf of the government is “generally committed to [its] absolute discretion.”78 while its ability to dismiss a claim may not be expressly absolute, there is a presumption that the government acts rationally and in good faith.79 since there is no language in the statute that explicitly limits its “historical prerogative” to decide what cases to pursue, it follows that the hearing provided for in the statute is simply a formal opportunity for the relator to convince the government not to dismiss the case.80 the d.c. circuit concluded their analysis by applying the rational basis test it declined to adopt, finding that, even under the ninth circuit’s approach, the relator’s claim failed to show the government’s motion to dismiss was arbitrary 72. id. (citing united states ex rel. neher v. nec corp., no. 92-2854, slip op. at 30 (11th cir. apr. 28, 1995)). 73. id. at 252. 74. id. 75. id. (citing heckler v. chaney, 470 u.s. 821, 831-33 (1985)). 76. id. at 253. 77. id.; see also randall v. merrill lynch, 820 f.2d 1317, 1320 (d.c. cir. 1987). 78. swift, 318 f.3d at 252 (citing heckler, 470 u.s. at 831-33). 79. id. at 253. see, e.g., rinaldi v. united states, 434 u.s. 22, 30 (1977)). 80. swift, 318 f.3d at 253. 200 indiana health law review [vol. 19:191 and capricious.81 the government asserted the dollar recovery was not large enough to cover the resources necessary to monitor the case, comply with discovery requests, and that the case would divert resources from more significant cases.82 the d.c. circuit reasoned that under the ninth circuit’s standard, the government’s goal of minimizing expenses was a legitimate objective and that dismissal furthered that objective.83 this final exercise is worth noting because subsequent cases have followed a similar model: parties arguing for and against dismissal in qui tam suits apply the holdings of both the ninth and d.c. circuits in the absence of a clear holding from united states supreme court. c. cimznhca, the seventh circuit’s standard in cimznhca, venari partners, a four-member partnership of corporate investors, formed eleven daughter companies for the purpose of prosecuting eleven separate qui tam actions.84 the relator in this case, cimznhca, llc, alleged that defendants illegally paid physicians to prescribe a drug it manufactured to patients who received benefits under federal healthcare programs.85 the alleged illegal payments came in the form of free education services by nurses to physicians and patients and free insurance reimbursement support services.86 the government chose not to intervene, but moved to dismiss the case using its authority under 31 u.s.c. § 3730(c)(2)(a), representing that it investigated the claims and found them “to lack sufficient merit to justify the cost of investigation and prosecution and otherwise to be contrary to the public interest.”87 the district court denied the government’s motion to dismiss.88 in doing so, “the court considered first what standard of review to apply to the government’s motion under 31 u.s.c. § 3730(c)(2)(a),” which is not explicitly provided for in the statute. the government, seeking broad authority to dismiss qui tam suits for the reasons discussed in both the granston memo and swift, urged the court to adopt the “unfettered discretion” standard espoused in swift.89 the relator, on the other hand, urged the court to apply the more relatorfriendly “rational relation” burden-shifting test from sequoia orange. reasoning that congress would not legislate the hearing requirement in 31 u.s.c. § 3730(c)(2)(a) to discuss a “preordained outcome,” the district court decided the standard applied by sequoia orange was the proper one and found the government’s decision was “arbitrary and capricious” and “not rationally related 81. id. at 254. 82. id. 83. id. 84. united states ex rel. cimznhca, llc, v. ucb, inc., 970 f.3d 835, 839 (7th cir. 2020). 85. id. at 840. 86. id. 87. id. 88. id. 89. id. 2022] the beginning and end of our analysis 201 to a valid government purpose.”90 the government appealed the lower court’s decision. however, before considering the appeal, the court had to wrestle with a jurisdictional dilemma: while courts ordinarily have appellate jurisdiction over final judgments and a few categories of interlocutory orders, denials of motions to dismiss rarely fit into these categories.91 the government argued denial of the motion to dismiss under 31 u.s.c. § 3730(c)(2)(a) was a “collateral order” and by “practical construction” under 28 u.s.c. § 1291, was a final judgment and thus immediately appealable.92 however, the seventh circuit noted the government’s argument would necessitate creating a new category of collateral orders and require a ruling on “the entire category” of orders, not just the order in question here.93 this is to avoid creating a new category of collateral order, which the supreme court has firmly discouraged. 94 the seventh circuit overcame the jurisdictional question by construing the government’s motion to dismiss as a motion to intervene and a motion to dismiss, a procedural interpretation that is critical to its ultimate holding. the court reasoned the government’s dismissal authority under 31 u.s.c. § 3730(c)(2)(a) was, in substance and form, both a motion to intervene and a motion to dismiss.95 in substance, an intervenor comes between the original parties and asserts some claim, interest, or right, which may be adverse to either or both parties.96 in form, the government sought to exercise its authority under a section of the fca that bears the heading “rights of the parties to qui tam actions.”97 it follows that the government cannot exercise this authority under 31 u.s.c § 3730(c), “unless and until it intervenes.”98 note that this reading undermines the d.c. circuit’s interpretation in swift that “proceeding” with the action means that “the case will go forward with the government running the litigation.”99 treating the government’s motion as one to intervene enabled the seventh circuit to apply federal rule of civil procedure 41 in the absence of an explicit standard in 31 u.s.c. § 3730(c)(2)(a). normally, rule 41(a)(1) permits the plaintiff absolute dismissal authority if the motion is filed prior to defendant filing an answer or motion for summary judgment, but it does not authorize an intervenor-plaintiff to dismiss the original plaintiff’s claim.100 however, the rule 90. id. 91. 1id. at 842. 92. d.(citing mohawk indus. v. carpenter, 558 u.s. 100, 103 (2009)). 93. id. 94. see mohawk, 558 u.s. at 103. 95. cimznhca, 970 f.3d at 843. 96. see united states ex rel. eisenstein v. city of new york, 556 u.s. 928, 933 (2009). 97. cimznhca, 970 f.3d at 844. 98. id. 99. swift v. united states, 318 f.3d 250, 251 (d.c. cir. 2003). 100. see washington elec. co-op., inc. v. mass. mun. wholesale elec. co., 922 f.2d 92, 97 (2d cir. 1990). 202 indiana health law review [vol. 19:191 is also subject to “any applicable federal statute.”101 here, the applicable statute is 31 u.s.c § 3730(c)(2)(a), which allows the government to dismiss the action without the plaintiff’s consent if the relator receives notice of the motion and the opportunity to be heard.102 the court went on to address the purpose of the hearing required by 31 u.s.c. § 3730(c)(2)(a). noting that “[t]he law does not require the doing of a useless thing,”103 it recognized that the value of the mandatory hearing is casespecific. while the government has the authority to dismiss the action under the combination of federal rule of civil procedure 41(a)(1) and 31 u.s.c § 3730(c)(2)(a) in cases where the motion is filed prior to the defendant’s answer, motions to do so after the defendant has filed an answer would fall under federal rule of civil procedure 41(a)(2) and may require a hearing to negotiate the terms of what is “proper” under a court-ordered dismissal.104 after dispensing with the jurisdictional question and clarifying the purpose of the hearing requirement in 31 u.s.c 3730(c)(2)(a), the seventh circuit ultimately reversed the district court’s decision, holding that “in the absence of a specific standard in 31 u.s.c. § 3730(c)(2)(a),” federal rule of civil procedure 41(a) was the “beginning and the end of its analysis.”105 rule 41(a)(1)(a)(i) provides that subject to “any applicable federal statute, the plaintiff may dismiss an action without a court order by filing a notice of dismissal before the opposing party serves either an answer or motion for summary judgment.”106 in so holding, the seventh circuit created the now three-circuit split, toeing the line between “unfettered authority” from the d.c. circuit and the “rational relation” test in the ninth circuit. d. the granston memorandum after the 1986 amendments, the number of whistleblower claims continued to increase, as did the costs for monitoring and litigating cases. the doj needed to reign in the human and financial resources it expended on qui tam actions. in 2018, michael granston, director of the fraud section of the commercial litigation branch at the doj, issued a confidential internal memorandum encouraging its attorneys to consider exercising more judiciously its dismissal authority under 31 u.s.c. § 3730 (c)(2)(a) when doing so would best serve the interests of the united states government.107 the memo justified this proposed 101. fed. r. civ. p. 41(a)(1). 102. 31 u.s.c. § 3730(c)(2)(a). 103. cimznhca, 970 f.3d at 850 (citing mashi v. i.n.s., 585 f.2d 1309, 1314 (5th cir. 1978)). 104. id. fed r. civ. p. 41(a)(2) provides, in relevant part, “except as provided in rule 41(a)(1), an action may be dismissed at the plaintiff’s request only by court order, on terms that the court considers proper.” 105. cimznhca, 970 f.3d at 849. 106. fed. r. civ. p. 41. 107. see memorandum from michael d. granston, dir., com. litig. branch, fraud section, 2022] the beginning and end of our analysis 203 heightened consideration of dismissal on the grounds that “record” annual totals of qui tam actions—approaching or exceeding 600 new cases annually—requires significant resources, even when the government declines to intervene.108 in cases where the government does not intervene, it must still expend significant resources and staff hours monitoring the action.109 the memo lays out seven factors for evaluating whether to seek dismissal of a relator’s claim.110 for the sake of brevity, they can be summarized as follows: 1. where the complaint is “facially lacking in merit”– either because the relator’s legal theory is inherently defective, or the factual allegations are frivolous.111 2. where the action “duplicates a pre-existing government investigation and adds no useful information to the investigation,” also known as a parasitic suit.112 3. where the action “threatens to interfere with an agency’s policies of the administration of its programs and has recommended dismissal to avoid these effects.”113 4. where the dismissal is “necessary to protect the department’s litigation prerogatives.”114 5. where dismissal would “safeguard classified information.”115 6. where “the government’s expected costs are likely to exceed expected gain.”116 7. where the action would “frustrate the government’s efforts to conduct a proper investigation.117 the memo also advises doj attorneys that its position has been that the appropriate standard of dismissal is the “unfettered” discretion standard adopted in swift, but that the prudent course of action may be to identify and support the government’s basis for dismissal in jurisdictions where the standard remains unresolved.118 these factors for dismissal and the doj’s position that swift is the appropriate standard are relevant to the public policy merits of the different standards adopted by the several circuits. the public policy impact of these standards will be discussed in detail below. to att’ys, com. lit. branch, fraud section & assistant u.s. att’ys handling false claims act cases, offices of the u.s. att’ys (jan. 10, 2018) (on file with author). 108. id. at 1. 109. id. 110. id. at 3-8. 111. id. at 3-4. 112. id. at 4. 113. id. at 4-5. 114. id. at 5. 115. id. at 6. 116. id. at 6-7. 117. id. 118. id. 204 indiana health law review [vol. 19:191 iv. analysis a. scotus should adopt the seventh circuit standard as pointed out by the granston memo, the doj is experiencing record numbers of qui tam lawsuits but lacks adequate resources to pursue them.119 if historical trends of increased fraud in the wake of massive government spending persist, the ever-increasing stimulus packages and grant funding appropriated in response to the covid-19 pandemic will certainly be followed by a tidal wave of qui tam actions. the influx of relator claims presents a massive expenditure of doj time and resources, even for those where they simply monitor rather than intervene. although the supreme court has declined to settle the circuit split for almost twenty years, the potential for high numbers of qui tam claims related to the covid-19 spending packages places the supreme court in a timely position to settle the split. of the three standards, the supreme court should adopt the interpretation offered by the seventh circuit in cimznhna because it captures the intent of the other circuits without creating a standard not provided for in the statute or granting the government overly-broad authority to dismiss actions at the expense of qui tam relators. the seventh circuit in cimznhca provides a solution to the “false choice” between the standards in sequoia orange and swift.120 by interpreting the government’s motion to dismiss as a motion to intervene and dismiss—as the court did when overcoming its jurisdictional hurdle—federal rule of civil procedure 41, in combination with 31 u.s.c. § 3730(c)(2)(a), adopts a procedurally sound standard with similar deference to the government’s discretion in the standard used by the d.c. circuit in swift, without exceeding the bounds of the explicit language in either the rule or the statute. adopting the seventh circuit rule would allow the government to intervene, with or without a “legitimate” purpose, and exercise only its explicit authority under 31 u.s.c. § 3730(c)(2)(a) to dismiss a claim—if it does so before the defendant files an answer or motion for summary judgement.121 this grants the government substantially similar authority as allowed by the d.c. circuit in swift for cases in which it moves to intervene and dismiss during the sixty day seal period. furthermore, it provides a clear procedural footing for government motions to dismiss in cases where, after declining to intervene initially, it moves to do so under 31 § u.s.c. 3730(c)(3) after the relator proceeds with the action on its own. this note advocates for adopting the cimznhca standard from several viewpoints, including the interpretations of congressional intent by each circuit, the two theories of statutory construction, the constitutionality of the fca, and the consideration of public policy. 119. id. 120. united states ex rel. cimznhca, llc, v. ucb, inc., 970 f.3d 835, 840 (7th cir. 2020). 121. fed. r. civ. p. 41(a)(1)(a). 2022] the beginning and end of our analysis 205 b. congressional intent central to the disagreement among the circuits is whether congress intended some form of judicial review and to what extent it is provided for in the statute. the ninth circuit, looking to the senate report on the 1986 amendments for indications of legislative intent, adopted a standard based on senator chuck grassley’s committee testimony that the amendments would prevent the government from dismissing allegations of false claims “without legitimate reason.”122 senator grassley recently reiterated those intentions during a speech on the senate floor commemorating whistleblower appreciation day.123 while not persuasive authority, his comments were critical of the doj “dismissing charges [. . .] without [the government] stating its reasons” and opined that “the attorney general should have to state the legitimate reasons for deciding not to pursue [the actions].”124 these comments provide at least tacit support for a standard similar to the one adopted by the ninth circuit in sequoia orange.125 senator grassley also recently penned a letter to then-united states attorney general barr that criticized the doj because it “did not thoroughly investigate [cases] it argued lacked merit; argued for dismissal on policy grounds while admitting the claims present[ed] a classic violation of law; and finally, failed to do a cost-benefit analysis while arguing that litigation would be too costly.”126 the consistent advocacy by senator grassley is, while not persuasive for judicial purposes, arguably evidence of congressional intent for some limitation on the government’s dismissal authority. senator grassley recently announced plans to amend the fca further to “clarif[y]” purported “ambiguities created by the courts” on the proper interpretation of the fca.127 coupled with the lengthy discussion of congressional intent from the senate report in sequoia orange, it is evident why the ninth circuit was insistent the government state its reasons for seeking dismissal and that those reasons be rationally related to a legitimate government purpose. however, as the d.c. circuit pointed out in swift and the seventh circuit in cimznhca, the comments relied upon in the senate report were from an 122. s. rep. no. 99-345, at 25-26 (1986). 123. press release, sen. chuck grassley, grassley celebrating whistleblower appreciation day (july 30, 2020), https://www.grassley.senate.gov/news/news-releases/grassley-celebratingwhistleblower-appreciation-day [https://perma.cc/zs6p-kjse]. 124. id. 125. see united states ex rel. sequoia orange co. v. baird-neece packing corp., 151 f.3d 1139 (9th cir. 1998). 126. letter from charles e. grassley, chairman, sen. comm. fin., to hon. william barr, att’y gen., u.s. dep’t just. (sept. 4, 2019), https://www.grassley.senate.gov/news/newsreleases /g rass ley-q uestions-use-doj-memo-limit-recovery-tax-dollars-lost-fraud [https://perma.cc/jsc3-bcf3]. 127. press release, sen. chuck grassley, supra note 123. 206 indiana health law review [vol. 19:191 unenacted version of the 1986 amendments and related to provisions which were not ultimately included in the final language.128 thus, the d.c. circuit maintained, the only indication of congressional intent to permit judicial review of dismissal motions was the hearing requirement under 31 u.s.c § 3730(c)(2)(a).129 however, the court points out that supreme court precedent establishing a presumption of rationality and good faith on the part of the executive branch in carrying out its duties under the take care clause of the constitution renders hearings simply a formal opportunity for the relator to convince the government not to end the case.130 it does not, as the swift court says, “[set] ‘substantive priorities’ nor [circumscribe] the government’s ‘power to discriminate among issues or cases it will pursue.’”131 without the inference of congressional intent from the senate report or hearing requirement, the d.c. circuit dispensed with the notion of judicial review and adopted its “unfettered right” standard.132 the seventh circuit agreed with swift’s dismissal of congressional intent. consistent with its adherence to the actual text of the statute, as discussed in the next section, the seventh circuit declined to premise a standard of dismissal merely on a senate report.133 like the d.c. circuit, the seventh circuit stated that “[i]f congress wishes to require some extra-constitutional minimum of fairness, reasonableness, or adequacy of the government’s decision under 3730(c)(2)(a), it will need to say so.”134 for example, the very next subsection of the statute provides that the government may settle an action “if the court determines, after a hearing, that the proposed settlement is fair, adequate, and reasonable under all the circumstances”(emphasis added).135 this emphasis on the text of the act as written indicates the broader reliance on the textual interpretation by the seventh circuit in crafting its standard. we now turn to further examination of that approach. c. textual interpretation two of the primary canons of statutory interpretation are “textualism” and “purposivism.” as textualism is treated more directly by cimznhca, this theory of statutory construction is discussed first. the next section will discuss the purposive theory of construction. without a closer review of the textual interpretation of the cimznhca standard, it is tempting to simply accept the “unfettered” swift standard rather 128. swift v. united states, 318 f. 3d 250, 253 (d.c. cir. 2003) (citing s. rep. no. 99-345, at 42 (1986)). 129. id. 130. id. see, e.g., rinaldi v. united states, 434 u.s. 22, 30 (1977). 131. swift, 318 f. 3d at 253. 132. id. at 252. 133. united states ex rel. cimznhca, llc v. ucb, inc., 970 f.3d 835, 853 (7th cir. 2020). 134. id. see 31 u.s.c. § 3730(c)(2)(b). 135. 31 u.s.c § 3730(c)(2)(b). 2022] the beginning and end of our analysis 207 than jumping through the “largely academic”136 textual interpretation differences articulated in cimznhca. the breadth of the swift standard is, in part, based on its textual interpretation of the phrase “subject to the limitations set forth in paragraph (2)” in 31 u.s.c § 3730(c)(1).137 here, the court engages in a discussion of the relevance of the type setting and placement of the text of the fca to explain the scope of the government’s authority to dismiss claims. the relevant part of 31 u.s.c § 3730 appears as follows: (c) rights of the parties to qui tam actions. — (1) if the government proceeds with the action, it shall have the primary responsibility for prosecuting the action and shall not be bound by an act of the person bringing the action. such person shall have the right to continue as a party to the action, subject to the limitations set forth in paragraph (2). (2) (a) the government may dismiss the action notwithstanding the objections of the person initiating the action if the person has been notified by the government of the filing of the motion and the court has provided the person with an opportunity for a hearing on the motion.138 according to the relator in swift, the phrase “subject to the limitations set forth in paragraph (2)” limits the government’s dismissal power only within the context of 31 u.s.c § 3730(c)(1), which would require the government to first intervene and “proceed” with the action.139 the court, however, sided with the government and took the opposite perspective: that the language acts only to limit the ability of the relator to continue as a party to the action, thus applying the dismissal authority in section (c)(2) to the entirety of section (c).140 stated differently, “the second sentence of § 3730(c)(1) is limited by § 3730(c)(2), but § 3730(c)(2) is independent of § 3730(c)(1).”141 this broad applicability of section (c)(2) is a partial basis for the swift standard’s “unfettered” ability to dismiss qui tam claims. contrast this interpretation with the textual interpretation from cimznhca. the seventh circuit opens its textual interpretation by pointing out that the heading of section (c)—”rights of the parties to qui tam actions”—implies that the proceeding sections apply to parties to the action.142 the court notes this would seem to require the government to intervene before taking advantage of its 136. swift, 318 f.3d at 252. 137. id. at 251. 138. 31 u.s.c. § 3730(c)(2)(a). 139. see swift, 318 f.3d at 251. 140. id. at 251-52. 141. id. at 252. 142. united states ex rel. cimznhca, llc, v. ucb, inc., 970 f.3d 835, 845 (7th cir. 2020). 208 indiana health law review [vol. 19:191 dismissal authority.143 stated differently, the government must become a party to the action before exercising its authority under 31 u.s.c § 3730(c)(2)(a). the court goes on to criticize the reading in swift that “paragraph (2) is entirely free floating,” for several reasons.144 first, it points out that the surrounding paragraphs in subsection (c) announce the procedural posture to which they apply.145 thus, reading paragraph (2) as “free-floating” makes surplusage of those procedural posture provisions, notably the provision in paragraph (1) that a relator may continue as a party “subject to the limitations set forth in paragraph (2)” after the government intervenes.146 put differently, if in fact paragraph (2) applies in every circumstance under subsection (c), the relator’s continued participation as a party is subject to that paragraph.147 the anti-surplusage canon of statutory construction points toward interpreting the language as limited to subsection (c)(1) rather than a free-floating standard as suggested in swift. the court also points out the inherent contradiction of the swift approach, which places an across-the-board “qualified right to conduct the action” on the relator when several other subparagraphs bestow a “nearly unqualified” right where the government does not wish to dismiss the action.148 it is for these reasons that the seventh circuit ultimately limits the applicability of paragraph (2) to those situations in which the government intervenes.149 this limited interpretation, as discussed in previous sections, is the foundation upon which the seventh circuit’s deference to federal rule of civil procedure 41 is built. by limiting the dismissal authority in 31 u.s.c. § 3730(c)(2)(a) to only situations in which the government intervenes during the sixty day seal period, it provides additional support for the explicit dismissal authority by placing the motions to dismiss within the framework of the wellestablished federal rules of civil procedure. in so doing, it also places the later sections of 31 u.s.c. § 3730—to which the now-limited “unfettered” authority would no longer apply—within the same well-established framework. as briefly discussed above, motions to dismiss filed after the sixty day seal period has ended, where the government declines to intervene, and the relator “conducts the action” independently, fall under federal rule of civil procedure 41(a)(2).150 taken with 31 u.s.c § 3730(c)(3), the federal rules of civil procedure build in two layers of protection for relators. first, statute permits the government “to 143. id. at 844 (citing ortega v. holder, 592 f.3d 738, 743 (7th cir. 2010)) (“[w]e must consider not only the words of the statute, but also the statute’s structure.”). 144. cimznhca, 970 f.3d at 844. 145. id.; see, e.g., 31 u.s.c. § 3730(c). 146. cimznhca, 970 f.3d at 844 (citing reiter v. sonotone corp., 442 u.s. 330, 339 (1979)) (explaining the anti-surplusage canon); see also antonin scalia & bryan a. garner, reading law: the interpretation of legal texts 156 (2012) (“material within an indented subpart relates only to that subpart.”). 147. cimznhca, 970 f.3d at 844. 148. id. at 845. 149. id. 150. 31 u.s.c. § 3730(c)(3). 2022] the beginning and end of our analysis 209 intervene at a later date upon a showing of good cause.”151 second, if the government is permitted to intervene and moves to dismiss, the motion is subject to federal rule of civil procedure 41(a)(2), which gives the court discretion to order dismissal only on terms it considers proper.152 as pointed out in cimznhca, this interpretation would provide a hearing that is beyond a “mere formality,” another criticism of the d.c. circuit’s textual interpretation. it is also worth pointing out that providing for a meaningful hearing gives credence to the ninth circuit’s stance in sequoia orange that the absence of a standard contemplates some form of judicial review for relators who have proceeded with a case on their own. the plain language of federal rule of civil procedure 41(a)(2) permits dismissal only under circumstances the court deems proper.153 while review under this rule may not amount to the same scrutiny as the ninth circuit’s rational relation test, it does give purpose to the hearing requirement from 31 u.s.c. § 3730(c)(2)(a) and ensures the relator additional certainty of due process. d. purposive interpretation the purposive theory of statutory construction assumes “that legislation is a purposive act, and judges should construe statutes to execute that legislative purpose.”154 under this theory, courts are encouraged to interpret statutes “in a way that is faithful to congress’s purposes” by examining the legislative process.155 the ninth circuit in sequoia orange demonstrated this interpretation when it sought guidance from the senate reports on the 1986 amendments. for as long as qui tam statutes have been in place, their purpose has been to compel private citizens with knowledge of wrongdoing to bring that information forward. as was the case in prior iterations of the statute, the goal of the 1986 amendments was to once again incentivize citizen relators to assist the government in recovering fraudulent payments.156 the opening sentence of the senate report on the 1986 amendments states: “the purpose of s. 1526, the false claims reform act, is to enhance the government’s ability to recover losses sustained as a result of fraud against the government.”157 the committee believed the amendments to the qui tam provisions would alleviate the lack of enforcement capabilities by inviting private 151. id. 152. cimznhca, 970 f.3d at 850; fed r. civ. p. 41(a)(2) provides, in relevant part, “except as provided in rule 41(a)(1), an action may be dismissed at the plaintiff’s request only by court order, on terms that the court considers proper.” 153. fed. r. civ. p. 41(a)(2). 154. statutory interpretation: theories, tools, and trends, everycrsreport.com, (apr. 5, 2018), https://www.everycrsreport.com/reports/r45153.html#fn17 [https://perma.cc/2unakeh8] (citing robert a. katzmann, judging statutes 31 (2014)). 155. id. 156. s. rep. no. 99-345, at 13 (1986). 157. id. at 1. 210 indiana health law review [vol. 19:191 citizens to bolster the government’s fraud enforcement effort.158 it also made clear that the “committee’s overall intent in amending the qui tam section of the false claims act is to encourage more private enforcement suits.”159 as the current circuit split demonstrates, the interests of the government and private relators are not always aligned, and the courts are split as to who congress intended to benefit. relying on the senate report, the ninth circuit in sequoia orange determined congress’ intent was that qui tam relators “[act] as a check that the government does not neglect evidence, cause undue delay, or drop the false claims case without legitimate reason.”160 however, as pointed out in swift, the section of the senate report that sequoia orange relies upon is from an unenacted version of the bill.161 while the swift court dismissed the legislative intent in this section of the senate report by focusing instead on the text of the statute, the senate report does also offer some support for the “unfettered discretion” standard of dismissal adopted in swift and the more well-structured approach in cimznhca. the cimznhca standard construes the government’s motion to dismiss a relator’s qui tam claim under 31 u.s.c. § 3730(c)(2)(a) as a motion to intervene and dismiss. while the swift court does not believe this is necessary based on the plain language of the statute, there is some support for the cimznhca standard in the senate report. the 1986 amendments added the sixty day seal requirement to the fca.162 the committee stated the seal period is “intended to allow the government an adequate opportunity to fully evaluate the private enforcement suit and determine [. . .] whether it is in the government’s interest to intervene and take over the civil action” (emphasis added).163 it goes on to say that “nothing in the statute, however, precludes the government from intervening before the 60-day period expires” (emphasis added).164 this intent is clearly reflected in the text of the fca in 31 u.s.c. § 3730 (b)(2), which provides: “[t]he government may elect to intervene and proceed with the action within 60 days after it receives both the complaint and the material evidence and information” (emphasis added).165 it is logical, therefore, to infer congress conceptualized the rights of relators and the government within the context of the federal rules of civil procedure, which would require the government to intervene in the suit, like any other intervenor plaintiff, before proceeding with the action. it follows, then, that although the 158. id. at 7-8. 159. id. at 23-24. 160. united states ex rel. sequoia orange co. v. baird-neece packing corp., 151 f.3d 1139, 1144 (9th cir. 1998) (citing s. rep. no. 99-345, at 25-26 (1986)). 161. swift v. united states, 318 f.3d 250, 253 (d.c. cir. 2003) (citing s. rep. no. 99-345, at 42 (1986)). 162. s. rep. no. 99-345, at 23 (1986). 163. id. at 24. 164. id. 165. 31 u.s.c. § 3730(b)(2). 2022] the beginning and end of our analysis 211 dismissal authority in 31 u.s.c. § 3730(c)(2)(a) lacks explicit language requiring the government to intervene, members of the committee arguably conceptualized motions to dismiss filed in accordance with this section within the rules of civil procedure. additionally, if the committee did intend the government to have “unfettered authority” to do so, the ability to dismiss a suit without order of the court permitted already provided for by federal rule of civil procedure 41(a)(1)(i) is effectuated by the more specific language in § 3070(c)(2)(a), which grants the government the authority to dismiss the suit “notwithstanding the objections of the person initiating the action.”166 e. constitutional underpinnings several other courts reject the cimznhca interpretation that 31 u.s.c. § 3730(c)(2)(a) requires the government to intervene prior to dismissing the action on the grounds that the intervention requirement is a violation of the take care clause of article ii § 3 of the constitution. one such court is the tenth circuit, which concluded in ridenour v. kaiser-hill co. that “to condition the government’s right to move to dismiss an action in which it did not initially intervene upon a requirement of late intervention tied to a showing of good cause would place the fca on constitutionally unsteady ground.”167 in ridenour, the government initially declined to intervene in a qui tam action brought against a security contractor, but eight months later moved to dismiss the action when it determined allowing the action to continue may compromise national security interests.168 it sought this dismissal without purporting to intervene, as doing so would implicate the requirement that the government show “good cause” for doing so under 31 u.s.c. § 3730(c)(3).169 the court agreed with the government’s assertion that it was not required to intervene, citing to the d.c. circuit’s interpretation in swift that intervention is “necessary only if the government wishes to ‘proceed with the action’” (emphasis added), and in accordance with the constitutional-doubt canon of statutory interpretation.170 the canon, according to the tenth circuit, obligates the court “to interpret statutes in a manner that renders them constitutionally valid” and requires it to “avoid an interpretation that unnecessarily binds the government.”171 in function, this holding meant the government was not required to show good cause before moving to intervene after the sixty day seal period for the purpose of dismissing an action under 31 u.s.c. § 3730(c)(2)(a).172 the seventh circuit in cimznhca characterizes the ridenour reasoning as 166. 31 u.s.c. § 3730(c)(2)(a). 167. ridenour v. kaiser-hill co., 397 f.3d 925, 934 (10th cir. 2005). 168. id. at 929-30. 169. id. at 932. 170. id. at 933-34 (citing swift v. united states, 318 f.3d 250, 252 (d.c. cir. 2003)). 171. id. at 934 (citing zadvydas v. davis, 533 u.s. 678, 689 (2001)). 172. id. at 935. 212 indiana health law review [vol. 19:191 “misguided.”173 as articulated in cimznhca, “[t]he canon of constitutional doubt teaches that when two interpretations of a statute are ‘fairly possible,’ one of which raises a ‘serious doubt’ as to the statute’s constitutionality and the other does not, a court should choose the interpretation ‘by which the question may be avoided.’”174 the seventh circuit cites two flaws in the tenth circuit’s application of this canon. first, the court “inverted the constitutional-doubt canon.”175 by failing to articulate what constitutes “good cause” for purposes of 31 u.s.c. § 3730(c)(3)—which is itself a “flexible and capacious concept”—the tenth circuit simply assumed any “good cause” requirement would be unconstitutional rather than consider the possibility that the very risk of separation of powers may itself be part of a judicial “good cause” determination.176 second, the historical foundation of the concept of qui tam actions in both english and american legal systems, and the supreme court’s decision to reserve judgment on the fca’s constitutionality under article ii, do not indicate a serious possibility that the constitutionality of the fca “will stand or fall” on a good cause requirement to intervene and dismiss a qui tam action.177 f. public policy considerations for the reasons detailed in the granston memo, there are legitimate public policy considerations for adopting a standard that gives substantial deference to the government. as briefly discussed in the opening sentences of this note, the massive government spending in response to the covid-19 pandemic, coupled with a high volume of relator claims, presents a looming burden on the doj. adopting a standard that is deferential to federal regulators, especially one similar to that which it maintains is the appropriate standard, could be critical to the efficient operation of the doj.178 as mentioned previously, the cares act provided $2.2 trillion for government aid to mitigate the economic impact of covid-19 through programs with the small business administration loan program, the paycheck protection program, and the health-care specific provider relief fund.179 a follow-up package in late december 2020 provided an additional $900 billion toward relief efforts. at the time of writing, the u.s. house of representatives and senate each passed budget resolutions that included funding for president biden’s $1.9 trillion covid-19 relief package.180 as the funding continues to increase, so too do the 173. united states ex rel. cimznhca, llc, v. ucb, inc., 970 f.3d 835, 836 (7th cir. 2020) (citing zadvydas, 533 u.s. at 689). 174. id. at 846 (citing zadvydas, 533 u.s. at 689). 175. id. 176. id. at 847. 177. id. at 848. 178. memorandum from michael d. granston, supra note 107. 179. bosack & beck, supra note 2. 180. andrew duehren, senate moves forward with biden’s $1.9 trillion covid-19 relief plan, wall st. j. (feb 5. 2021, 10:12 am), https://www.wsj.com/articles/gop-puts-minimum2022] the beginning and end of our analysis 213 opportunities for fraudulent claims. this is especially true in the health care sector. in the last four years, 80% of all fca recoveries have been related to health care or health care-related sectors.181 of the more than $2.2 billion recovered by the doj in fiscal year 2020, $1.8 billion relates to the health care industry.182 this figure does not include the billions in settlements, such as the multi-billion dollar settlement between the doj and purdue pharma in october 2020.183 suffice it to say, the continuous dedication of additional funding to the health care and health care-related sectors in response to covid-19 is all but certain to see this trend increase exponentially. prior to the pandemic, the granston memo cited concerns about the growing number of qui tam claims, the burden they place upon federal attorneys, and the “static” rate of government interventions.184 in fact, during the last five years, an average of approximately 800 new fca cases were filed each year, with approximately 660 cases filed by qui tam relators.185 in the last year alone, qui tam realtors filed 672 suits.186 interestingly, the federal government itself filed 250 cases last year, which arose from a variety of sources, including referrals from other agencies and by mining government spending data.187 despite senator grassley’s promise to file legislation to clarify the standard of dismissal for qui tam actions, no such bill has been filed as of the time of writing this note.188 thus, for at least the foreseeable future, the prevailing public policy will be the one outlined in the granston memo: the interests of the government are best served by judiciously exercising authority under 31 u.s.c. § 3730 (c)(2(a) to dismiss qui tam suits which satisfy the factors laid out in the memo. wage-school-reopenings-in-covid-aid-spotlight-11612467876 [https://perma.cc/7cz5-5tm2]. 181. 2020 year-end false claims act update, gibson dunn 1, 5 (2021), https://www. gibsondunn.com/wp-content/uploads/2021/01/2020-year-end-false-claims-act-update.pdf [https://perma.cc/75wj-3hdv]. 182. press release, u.s. dep’t just., justice department recovers over $2.2 billion from false claims act cases in fiscal year 2020 (jan. 14, 2021), https://www.justice.gov/opa/pr/justicedepar tm en t -r ecover s -over -2 2 -b il l ion -fa lse-c la im s-ac t -cases-fisca l-yea r -2 0 2 0 [https://perma.cc/6skt-2yjq]; press release, u.s. dep’t just., justice department announces global resolution of criminal and civil investigations with opioid manufacturer purdue pharma and civil settlement with members of the sackler family (oct. 21, 2020), https://www.justice. gov/opa/pr/justice-department-announces-global-resolution-criminal-and-civil-investigations-opioid [https://perma.cc/86l9-erez]. 183. id. 184. memorandum from michael d. granston, supra note 107, at 1. 185. 2020 year-end false claims act update, supra note 181, at 2. 186. justice department recovers over $2.2 billion from false claims act cases in fiscal year 2020, supra note 182. 187. 2020 year-end false claims act update, supra note 181, at 2. 188. sponsored legislation, chuck grassley u.s. sen. iowa, https://www.grassley.senate. gov/issues-legislation/sponsored-legislation [https://perma.cc/u8b9-y2ru] (last visited feb. 17, 2021). 214 indiana health law review [vol. 19:191 the statistics reported by the doj suggest a need to maximize prosecutorial discretion in deciding which cases to pursue. recall the rise of parasitic suits which led to the fca being gutted in the 1940s. the increased number of cases filed by the government in 2020 and subsequent years will certainly yield duplicative, overlapping claims filed by relators with knowledge of the same underlying fraudulent acts. the doj’s ability to invoke the second factor from the granston memo, where a qui tam action “duplicates a pre-existing government investigation and adds no useful information to the investigation,” would be critical to the efficient use of doj resources.189 similarly, there will certainly be qui tam claims which simply lack merit, either facially or because the underlying theory would lead to bad precedent. as the federal agency charged with carrying out the enforcement of the fca, the doj should have significant authority to dismiss such claims, so long as dismissal complies with due process rights of realtors. perhaps most significant to this discussion is the ability to dismiss claims where “the government’s expected costs are likely to exceed expected gain.”190 the unprecedented amount of money appropriated by congress in response to covid-19 will require the doj to operate as efficiently as possible in recovering fraudulent claims. even if the doj is afforded additional resources to pursue them, the sheer volume of claims certain to result from the pandemic response will require careful use of doj staff time and resources. v. conclusion without amendments to the fca that clarify the standard of dismissal under 31 u.s.c § 3730 (c)(2)(a) or how its dismissal provisions interact with the other paragraphs of the section, the supreme court should consider stepping in to settle the now three-way circuit split. the importance of a settled standard will only increase as the doj’s enforcement ramps up efforts and relators begin filing increasing numbers of qui tam actions in response to the massive government spending associated with covid-19. furthermore, with such enormous sums of money on the line for corporations, relators, and the doj, the uncertainty created by the lack of a definite standard leaves the door open for fca precedent to swerve in unpredictable directions. prior to adoption of the cimznhca standard, parties to qui tam actions—as encouraged in the doj justice manual—make arguments under two separate standards. at the time of this writing, it is unclear how much more work parties will be subjected to when drafting briefs advocating for dismissal and intervention now that there is a third standard to consider. regardless, there is certainly an argument to be made from a judicial resource standpoint regarding the length and complexity of adjudicating appeals of motions to dismiss and intervene. furthermore, the textual and purposive canons of statutory interpretation support providing the doj adequate prosecutorial discretion to carry out its 189. memorandum from michael d. granston, supra note 107, at 4. 190. id. at 6. 2022] the beginning and end of our analysis 215 enforcement duties while providing some recourse for the relator who has risked its reputation and livelihood to bring a qui tam case forward. even during committee discussion, legislators contemplated the procedural steps that would require the government to intervene and proceed with the action prior to acting on its motion to dismiss. it also explicitly recognized the financial and human resource limitations of the doj and its concerns that the influx of qui tam claims would stress its resources and could potentially interfere ongoing criminal investigations.191 congress acknowledged and explicitly addressed these concerns in the final version of 31 u.s.c § 3730 (c)(2)(a). the seventh circuit’s standard in cimznhca provides a procedurally structured solution to the three-way split over the scope of the government’s dismissal authority under 31 u.s.c § 3730 (c)(2)(a). by limiting the applicability of paragraph (2), as the seventh circuit’s textual interpretation suggests, the government will continue to enjoy broad dismissal authority similar to that which it enjoys under the swift standard. this limitation on the otherwise “unfettered” authority allowed by swift may ultimately lead to more expeditious decisions on the part of doj regulators who, under the cimzhnca standard, would be required to seek the court’s permission to intervene for “good cause” if they initially decline to intervene and dismiss and later seek to do so under 31 u.s.c § 3730 (c)(3). in addition to the judicious use of government resources, decisions on whether to intervene earlier in the course of a qui tam action provide a cue to relators on the merits of their claim, as contemplated in the granston memo.192 furthermore, the seventh circuit standard places the procedural aspects of litigating qui tam dismissal and intervention claims on sound constitutional and procedural footing by couching the entire analysis within the framework of the federal rules of civil procedure. 191. s. rep. no. 99-345, at 24 (1986). 192. see generally memorandum from michael d. granston, supra note 107. health care reforms and the challenge of inequality from a human rights lens: lessons from europe elisavet athanasia alexiadou, phd, llm, msc* abstract over the last decade, in the european health landscape, several countries have adopted laws that impose health care reforms which entail the gradual implementation of structural reform, primarily cost-containment, measures and a privatization agenda in the health sector in order to curtail financial deficits. at the same time, however, socioeconomic health inequalities have raised dramatically, which in turn constitutes a serious area of human rights concern across europe. in fact, a growing number of individuals, especially those in vulnerable population groups, seem to encounter considerable impediments in accessing health care which is of decisive influence in terms of health outcomes. arguably, this disturbing development creates tension with human rights values, while it alludes that a human rights dimension might be completely absent from the formulation of health care reforms. following that, this article uses a human rights lens through which to examine the intersection between human rights commitments and imposed health care reforms. finally, as a way of addressing current and future imbalances in health care that generate inequality, the article concedes that health care reforms should be designed and implemented not in isolation from, but in consistency with human rights requirements and particularly with the right to health requirements. i. introduction in recent years, the european health landscape has witnessed a remarkable surge of health care reforms primarily prompted by the eurozone crisis and its associated fiscal pressure on several european union (eu) member states to alleviate public deficits and restore economic growth.1 the practical consequence of this development, along with the fact that health expenditure in most european countries was associated with significant amounts of public spending, meant that the latter has become a niche area, attracting the focused attention of many reformers and decision-makers in europe. meanwhile, within the context of a crisis-ridden socioeconomic environment, health inequalities constitute a persistent and egregious challenge, adversely affecting the health and well-being of a growing number of individuals and especially vulnerable population groups across europe.2 undoubtedly, as will be discussed in a later section of this paper, this alarming * lawyer, supreme court, greece, fellow, global health law groningen research center, faculty of law, university of groningen, netherlands. email: ea.alexiadou@gmail.com 1. see european comm’n expert panel on effective ways of investing in health, typology of health policy reforms and framework for evaluating reform effects (2016), https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/013_healthpolicyreforms_ reformeffects_en.pdf [https://perma.cc/8x78-ryza]. 2. see, e.g., 2012 o.j. (c 199 e/04). see also, infra note 5. 64 indiana health law review [vol. 17:63 situation creates tension with health rights and the values they embody, primarily when a human rights dimension is largely absent from the formulation and implementation of any proposed type of health care reform. perhaps, acknowledging the gravity of such concerns, the world health organization cautioned member states of their harmful implications for health and urged them “to ensure that their health systems continue to protect those most in need (the poor, the elderly, the sick and frail), to demonstrate effectiveness in delivering personal and population services, while cooperating with other sectors to encourage health equity considerations to be taken into account.”3 hence, the present analysis sets out to address what human rights can bring to health care reforms: (i) by paying attention to principal human rights standards that frame state obligations concerning health care provision and (ii) by assessing health care reforms within particular european realities through a human rights lens. arguably, this assessment aims to contribute to the social policy and political debate on the nature and scope of health care reforms, which concerns every country and every individual worldwide. essentially, it intends to serve as a piece of discussion about the extent to which imposed health care reforms across europe are complicit with human rights requirements and particularly with the right to health requirements. but first, the european dimension of socioeconomic health inequalities, an extensive challenge of our time, will be examined as crucial background information for the subsequent analysis. ii. unpacking the context for health care reforms: the challenge of inequality across europe inequality within and between countries constitutes a global phenomenon, driven by neoliberal political and economic policies and ideologies, advanced capitalism and austerity regimes that tend to subordinate social goals and undermine social rights.4 in europe, inequality took center stage in the political agenda in the aftermath of the eurozone crisis and the subsequent implementation of reform measures with significant adverse implications on publicly provided social services, including healthcare, and human welfare in general.5 arguably, inequality poses considerable risks to the life and health of individuals and groups, especially those in vulnerable situations, with long-lasting effects on their life course, while having a detrimental impact on economic development that goes across generations.6 3. world health organization regional committee for europe res. eur/rc59/r3, ¶ 3 (sept. 16, 2009). 4. see economic and social rights in a neoliberal world (gillian macnaughton & diane f. frey eds., 2018); audrey r. chapman, global health, human rights and the challenge of neoliberal policies (2016). 5. see, e.g., rita baeten, slavina spasova, bart vanhercke & stéphanie coster, inequalities in access to healthcare. a study of national policies (2018). 6. see id. see also organ. for econ. co-operation and dev. ctr. for opportunity and equa., understanding the socio-economic divide in europe – background report 2020] lessons from europe 65 as is well established, over the course of the last decade and particularly since the onset of the 2008 financial crisis, which severely affected the european region, socioeconomic inequality within and between eu member states has intensified.7 in fact, a recent report by the organisation for economic co-operation and development (oecd) affirms that the 2008 financial upheaval and the subsequent implementation of fiscal consolidation fueled a social crisis with “profound knockon effects on people’s job prospects, incomes and living arrangements,” added socioeconomic risks for vulnerable groups in society and long-term consequences in areas, like family formation, fertility and health; while the numbers living in households without any income from work, especially in those european countries hardest hit by the crisis, like greece and spain, highly increased.8 meanwhile, despite weak financial recovery within the eu in 2016, poverty rates were relatively high in southern european countries, such as greece, spain, italy, and portugal at almost 15%, while poverty in denmark and finland affected only 5-6% of the population.9 additionally, in 2016 life expectancy at birth in low-income european countries remained lower compared to that in high-income european countries, such as sweden, norway, and the netherlands, where life expectancy almost reached 85 years.10 nonetheless, these figures alone fail to capture the farreaching repercussions of inequality from one generation to the next. crucially, inequality constitutes the most pressing and enduring challenge facing certain population groups in europe, with the most socially disadvantaged one being the roma, the oldest and largest ethnic group in europe.11 indeed, for years the deep-rooted societal prejudices perpetuate roma segregation from mainstream society and tend to erode any effort for positive change, primarily geared towards unimpeded access to public social services.12 undeniably, the (2017), https://www.oecd.org/els/soc/cope-divide-europe-2017-background-report.pdf [https://perma.cc/u3gb-gjwy]. 7. see organ. for econ. co-operation and dev. ctr. for opportunity and equa., supra note 6. see also organ. for econ. co-operation and dev., society at a glance 2014: oecd social indicators-the crisis and its aftermath (2014), https://read.oecdilibrary.org/social-issues-migration-health/society-at-a-glance-2014_soc_glance-2014-en#page1 [https://perma.cc/3zjf-jmwx]. 8. see society at a glance 2014: oecd social indicators-the crisis and its aftermath, supra note 7, at 11. 9. org. for econ. co-operation and dev., society at a glance 2019: oecd social indicators-a spotlight on lgbt people 100-01 (2019), https://www.oecd-ilibrary.org/ d ocs e rver / soc_glance-2019-e n . p d f?e x p i r e s = 1 5 7 7 5 1 6 2 3 8 & i d = i d & a ccn a m e = guest&checksum=606ca3486bca7de233e9468e7176ae93 [https://perma.cc/wrl4-wlpt]. 10. id. at 110-11. 11. see the situation of roma in europe and relevant activities of the council of europe, parliamentary assembly (june 22, 2010), https://assembly.coe.int/nw/xml/xref/xrefxml2html-en.asp?fileid=17875&lang=en# [https://perma.cc/833q-wk6v]. see generally ian f. hancock, we are the romani people (2002). 12. see amnesty int’l, briefing human rights on the margins roma in europe 10 (2010), https://www.amnesty.org.uk/files/roma_in_europe_briefing.pdf [https://perma.cc/7jxa66 indiana health law review [vol. 17:63 historical prejudice and the stigmatization, compounded by the precariousness of life conditions and systematic marginalization from many aspects of daily life which most roma in europe experience, have considerable adverse implications for their health and human rights in general.13 as recent research has shown, roma in europe experience higher rates of mortality, especially infant mortality, and increased (avoidable) illness relative to majority population groups.14 additionally, the high levels of poverty, unemployment in conjunction with unregulated civil status (i.e., lack of insurance and identity documents) among roma intersect with their access to health care across europe and constitute significant barriers for the roma when seeking needed care.15 similarly, grave concerns arise often in relation to roma environmental matters, namely in terms of dire housing conditions and geographical segregation of roma settlements.16 for example, a 2016 nine-country survey conducted by the eu fundamental rights agency (eu-midis ii) noted that: (i) 80% of the roma surveyed continue to live below the at-risk-of-poverty threshold of their country, with employment rates below the eu average, and (ii) approximately one in two roma surveyed (41%) felt discriminated against due to ethnic origin at least once in one of crucial areas of daily life (i.e., at work, in education, and in healthcare) within the past five years.17 meanwhile, at this stage, it is essential to mention that other groups in europe, such as undocumented gkg6]; council recommendation, 2013 o.j. (c 378); elisavet a. alexiadou, ethnic diversity and access to healthcare from a human rights perspective: the case of the roma in europe, 25 eur. j. health l. 261 (2018). 13. thomas hammarberg, human rights in europe: no grounds for complacency 57-82 (2011). see generally hancock, supra note 11; alexiadou, supra note 12. 14. matrix, roma health report health status of the roma populationdata collection in the member states of the european union, 113-15 (2014), https://ec.europa.eu/ health/sites/health/files/social_determinants/docs/2014_roma_health_ report_en.pdf [https://perma.cc/a4nx-ver6]. see generally world health org. reg’l office for europe, improving the health of roma in the who european region: a new initiative of the who regional office for europe (2012), https://web.ua.es/es/iudesp/ documentos/ultima-hora/who-european.pdf [https://perma.cc/g5qt-pl6u]. 15. european commission, report on the implementation of the eu framework for national roma integration strategies, at 9-10, com (2014) 209 final (feb. 4, 2014). see generally world health org. reg’l office for europe, supra note 14. 16. see european union agency for fundamental rights, housing conditions of roma and travellers in the european union-comparative report (2009), https://fra.europa. eu/sites/default/files/fra_uploads/703-roma_housing_comparative-final_en.pdf [https://perma.cc/n874-5c9w]. see also european union agency for fundamental rights, the situation of roma in 11 eu member states-survey results at a glance (2012), https://fra.europa.eu/sites/default/files/fra_uploads/2099-fra-2012-roma-at-a-glance_en.pdf [https://perma.cc/ydb8-9qwf]. 17. european union agency for fundamental rights, second european union minorities and discrimination survey: roma-selected findings, 9-11, 14 (2016), https://fra.europa.eu/sites/default/files/fra_uploads/fra-2016-eu-minorities-survey-roma-selectedfindings_en.pdf [https://perma.cc/kl49-p3m3]. see alexiadou, supra note 12. 2020] lessons from europe 67 migrants, endure analogously disadvantaged and harsh conditions in europe – especially in terms of exposure to high levels of poverty, social isolation and increased health risks – harmful to their health and well-being.18 notably, considering this precarious reality, the european parliament critically declared in its 2011 resolution that “in many eu countries equitable access to healthcare is not guaranteed, either in practice or in law, for undocumented migrants” and called eu member states to effectively tackle socioeconomic health inequalities with special efforts to ensure that socially disadvantaged groups in society are reached.19 all in all, such worrisome trends largely uncover that societal conditions compounded by austerity regimes, persistent patterns of exclusion and disadvantage on the grounds of racial, social, national or ethnic origin or other status, remain tightly bound with individuals’ state of health as well as with the varying degrees of (health) inequalities.20 thereto, socioeconomic health inequalities within and between european countries call for comprehensive state reforms that involve the development of enabling environments (e.g., favorable laws and policies), to combat structural imbalances in accessing healthcare that generate these inequalities and ultimately place health rights at the center of the law and policy agenda by focusing attention on more than cost-benefit and marketoriented measures. at a practical level, this requires radical and comprehensive health care reform efforts that tackle the root causes of growing health inequalities with much attention paid to the several surrounding socioeconomic aspects (e.g., poverty, social exclusion) which constitute the overall context within which these reforms are to be implemented. in essence, addressing the growing problem of inequality constitutes a crucial prerequisite for countering or at least significantly mitigating the worsening of financial and social hardships and adverse impact on the realization of health rights; and finally, for paving the way for securing the function of equitable and universal health care reforms across europe. iii. human rights standards since the adoption of the first right to health provision in the 1946 who’s 18. see platform for international cooperation on undocumented immigrants, undocumented migrants and the europe 2020 strategy: making social inclusion a reality for all migrants in europe (2015), http://picum.org/wp-content/uploads/2017/11/ undocumentedmigrantsandeurope2020strategy_en.pdf [https://perma.cc/kfw7-8b8u. see also elisavet athanasia alexiadou, the right to health. a human rights perspective with a case study on greece, 215-247 (2016) (phd diss., leiden univ.). 19. european parliament, supra note 2 ¶¶ ad, 4. 20. see generally understanding health inequalities and justice: new conversations across the disciplines, (mara buchbinder, michele rivkin-fish & rebecca l. walker eds., 2016); commission on soc. determinants of health, closing the gap in a generation: health equity through action on the social determinants of health. final report of the commission on social determinants of health (2008), https://www.who.int / social_determinants/final_report/csdh_finalreport_2008.pdf [https://perma.cc/4v6q-egs3]. 68 indiana health law review [vol. 17:63 constitution, health rights are increasingly recognized in a world that is full of tensions and challenges, ranging from egregious inequality to economic recession and austerity regimes.21 admittedly, such worrying developments affront each individual’s inherent dignity, confirmed as the basis of human rights, as well as tend to erode strong political commitment to work towards the effective enjoyment of health rights.22 nevertheless, states, as primary duty-bearers, cannot escape from their binding health obligations, well-embedded in treaty texts, under any circumstances.23 health obligations have been firmly enshrined and elaborated in a number of international and regional (human rights) instruments as well as in national constitutions.24 as such, a system of legal health obligations is developed in virtue of which states have the prime and ultimate responsibility over the design, delivery, and regulation of healthcare in consistency with human rights requirements and particularly with right to health requirements. most notably, within the united nations (un) human rights system health was first legally affirmed as human right under the right to health provision (article 12) enshrined in the international covenant on economic, social and cultural rights (icescr), that mandates states parties to progressively take steps towards, inter alia, the creation of conditions that would ensure medical service and attention for all in the event of sickness.25 this state obligation is also declared in other international human rights treaties that focus on specific population groups. for instance, article 24 of the convention on the rights of the child (crc), explicitly requires states to ensure that no child is deprived of his or her right of access to health care services, involving the treatment of illness and rehabilitation of health.26 meanwhile, un bodies have drawn attention to the interpretation of health obligations by way of providing standards against which state performance within the healthcare domain can be assessed over time. in august 2000, the un committee on economic, social and cultural rights (cescr), the oversight body for the icescr, adopted the general comment no. 14 (gc no. 14) aiming to assist states parties with the implementation of their health obligations.27 in this regard, the cescr has explicitly stressed in its gc no. 14 that states parties have 21. see constitution of the world health organization, world health organization, https://www.who.int/governance/eb/who_constitution_en.pdf [https://perma.cc/f6re-7yhl]. see also, e.g., sources cited infra note 33. 22. see, e.g., g.a. res 217 (iii) a, universal declaration of human rights, art. 1 (dec. 10, 1948); international covenant on civil and political rights, dec. 16, 1966, 999 u.n.t.s 171, pmbl; international covenant on economic, social and cultural rights, dec. 16, 1966, 993 u.n.t.s 3, pmbl [hereinafter icescr]. 23. charles. r. beitz, the idea of human rights 114 (2009). 24. see, e.g., u.n. special rapporteur paul hunt, the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, u.n. doc. e/cn.4/2003/58 (feb. 13, 2003). 25. icescr, supra note 22, at arts. 12(d), 2(1). 26. convention on the rights of the child, nov. 20, 1989, 1577 u.n.t.s. 3. 27. comm. on econ., soc. & cultural rights, general comment no. 14: the right to the highest attainable standard of health, art. 12, u.n. doc. e/c.12/2000/4 (aug. 11, 2000). 2020] lessons from europe 69 a duty to respect the right to health by ensuring that all persons have equal access to preventive, curative and palliative health services [emphasis added], while they are obliged to ensure appropriate legislative control over issues relating to private health sector provision.28 interestingly, the committee went even further by specifying the state obligation “to ensure the right of access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups” as a first core and non-derogable obligation under the right to health.29 at the same time, the cescr has particularly emphasized that health care facilities, goods, and services (ranging from preventive and rehabilitative health services to appropriate treatment of prevalent diseases, illnesses and disabilities) are required to be available in sufficient quantity, accessible (physically,—geographically, and financially—regardless of whether the services are publicly or privately provided, and without discrimination), acceptable (respectful of medical ethics and culturally appropriate) and of good quality (collectively called as aaaq).30 in addition to the aaaq framework, the cescr made the further point that participatory (e.g., in the form of a social dialogue with affected individuals and groups) and accountability mechanisms (e.g., health sector reviews, patients’ rights bodies, national human rights institutions, and courts) are also crucial procedural elements in health-related decision-making, implementation, monitoring and evaluation of policies in the health sector.31 crucially, in its gc no.14, the cescr endorsed and reiterated a view earlier expressed in the alma-ata declaration that inequality in the health status of people both within and between countries is “politically, socially and economically unacceptable and is therefore, of common concern to all countries”.32 especially in circumstances of an economic and financial crisis, it is notable that the cescr has repeatedly underlined that adjustment programs and austerity measures should not disproportionately affect disadvantaged and marginalized individuals and population groups.33 such a statement is particularly important when it comes to equitable health care accessibility given that the imposition of economic reform 28. id. ¶¶ 33-35. 29. id. ¶¶ 43(a), 47. 30. id. ¶ 12. 31. id. ¶¶ 11, 17, 34, 43(f), 54, 55, and 59. see also, high-level working grp. on the health & hum. rts. of women, child. & adolescents, world health org., leading the realization of human rights to health and through health (2017); alicia e. yamin, beyond compassion: the central role of accountability in applying a human rights framework to health, 10 health & hum. rts j. 1 (2008); helen potts, participation and the right to the highest attainable standard of health (2008). 32. comm. on econ., soc. & cultural rights, supra note 27, ¶ 38. 33. letter from ariranga g. pillay, chairperson, u.n. comm. on econ., soc., and cultural rights, to states parties on economic, social and cultural rights, 2 (may 16, 2012). see generally comm. on econ., soc. & cultural rights, statement on public debt, austerity measures and the international covenant on economic, social and cultural rights, u.n. doc. e/c.12/2016/1 (july 22, 2016). 70 indiana health law review [vol. 17:63 measures, involving high payments for healthcare and especially the shift of healthcare costs to patients, tends to aggravate the existing vulnerability of particular individuals and groups in society, namely those who are often exposed to high levels of poverty and social exclusion, overtly leading to discrimination.34 indeed, in addition to the cescr, the un general assembly in 2012 explicitly affirmed the responsibility of states to direct action towards universal health care reforms, by requiring that: [a]ll people have access, without discrimination, to nationally determined sets of the needed promotive, preventive, curative and rehabilitative basic health services and essential, safe, affordable, effective and quality medicines, while ensuring that the use of these services does not expose the users to financial hardship, with a special emphasis on the poor, vulnerable and marginalized segments of the population.35 meanwhile, in general comment no. 15 the un committee on the rights of the child broadly acknowledged the state obligation to ensure universal coverage of quality primary health services, including prevention, health promotion, care and treatment services, and essential drugs, as a core obligation for the realization of the children’s right to health, from which states cannot derogate.36 at the regional level, the council of europe (coe) and the european union (eu) have both adopted “human rights” instruments which impose, inter alia, distinctive health care requirements on states. the (revised) european social charter (resc, henceforth: the charter) under the right to health provision (article 11) declares, inter alia, the state’s obligation to take measures associated with the appropriateness of the functioning of health care facilities and the effectiveness of health system reforms for the states to ensure that the overall system of health care is responsive to avoidable health risks and accessible to the entire population without discrimination.37 crucially, in terms of economically accessible health care, the charter specifies in article 13(1) that the state has to: ensure that any person who is without adequate resources and who is unable to secure . . . by his own efforts or from other sources, in particular by benefits under a social security scheme, be granted adequate assistance, and, in case of sickness, the care necessitated by his 34. comm. on econ., soc., & cultural rights, supra note 33; comm. on econ., soc., and cultural rights, supra note 27, ¶ 19. 35. g.a. res. 67/81, ¶¶ 8, 10 (dec. 12, 2010). 36. comm. on the rights of the child, general comment no. 15 (2013) on the right of the child to the enjoyment of the highest attainable standard of health, art. 24, ¶ 73(b), u.n. doc. crc/c/gc/15 (april 17, 2013). 37. european social charter (revised), council of europe 7 (may 3, 1996), https://rm.coe.int/168007cf93 [https://perma.cc/bc6p-w6s5]; european soc. charter secretariat, the right to health and the european social charter, information document, ilga europe 910 (march 2009), https://www.ilga-europe.org/sites/default/files/right_to_health_and_esc.pdf [https://perma.cc/7pp6-j882]. 2020] lessons from europe 71 condition.38 obviously, under this provision, the charter takes an explicit stance for universal health care and equality in health and health care. nonetheless, over the last years, the european committee of social rights (ecsr)—the body responsible for monitoring the application of the charter—has acknowledged in its case law the substandard or even the denial of access to health care for socially disadvantaged population groups across europe.39 recently, in the case of complaint no. 104/2014 lodged against the czech republic the ecsr held that “the health care system must be accessible to everyone, especially the health care should be available to all who require it, and free of charge to those without the necessary resources” [emphasis added].40 importantly, the committee found a violation of article 11 of the charter, by critically arguing that the state measures “do not sufficiently ensure health care for poor or socially vulnerable persons who become sick” and encounter disproportionate health risks.41 at the same time, the convention on human rights and biomedicine and its explanatory report give substantive meaning to the right to equitable access to health care recognized in its article 3 by requiring states to provide health care: (i) of appropriate quality, (ii) in accordance with the person’s medical needs, (iii) with the absence of unjustified discrimination and (iv) at a satisfactory degree.42 meanwhile, at eu level, the charter of fundamental rights of the eu (cfreu) 38. european social charter revised, supra note 37, at 8. 39. additional protocol to the european social charter providing for a system of collective complaints, council of europe arts. 1-2, 5, 8(1) (nov. 9, 1995), https://rm.coe.int/ coermpubliccommonsearchservices/displaydctmcontent?documentid=090000168007cdad [https://perma.cc/gve7-sn85]; european social charter (revised): ets no. 163, supra note 37 at art. 25. see, e.g., european comm, on soc. rights, no. 48/2008 european roma rights centre (errc) v. bulgaria, council of europe, https://www.coe.int/en/web/european-social-charter/ processed-complaints/-/asset_publisher/5gefkjmh2byg/content/no-48-2008-european-romarights-centre-errc-v-bulgaria?inheritredirect=false [https://perma.cc/st7g-ntth]; european comm, on soc. rights, no. 151/2017, european roma rights centre (errc) v. bulgaria, council of europe, https://www.coe.int/en/web/european-social-charter/processed-complaints//asset_publisher/5gefkjmh2byg/content/no-151-2017-european-roma-rights-centre-errc-vbulgaria?inheritredirect=false [https://perma.cc/vt7u-a4zt]. 40. european comm, on soc. rights, european roma and travellers forum (ertf) v. the czech republic, complaint no. 104/2014, council of europe ¶ 117, https://hudoc.esc.coe.int/ eng#{"escdcidentifier":["cc-104-2014-dmerits-en"]} [https://perma.cc/sk58-lh8n]. 41. id. ¶¶ 119-120. 42. convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine, council of europe 2 (april 4, 1997), https://rm.coe.int/168007cf98 [https://perma.cc/sy9v-svuc]; explanatory report to the convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine, council of europe ¶ 23-27 (april 4, 1997), https://rm.coe.int/16800ccde5 [https://perma.cc/42r3-9zu2]. 72 indiana health law review [vol. 17:63 recognizes in article 35 the right of everyone to access preventive health care and to benefit from medical treatment,43 while the treaty on the functioning of the eu (tfeu) in article 168(1) provides that “a high level of human health protection shall be ensured in the definition and implementation of all union policies and activities.”44 last but not least, growing awareness of the long-term impacts of the recent eurozone crisis on the social dimension of europe has led to the establishment of the european pillar of social rights, a soft law instrument that is addressed to all eu member states.45 the pillar enshrines twenty principles and rights to enhance the functioning of welfare systems across europe, and it is structured around three main categories, including social protection and inclusion.46 in fact, the social protection and inclusion category entails the right to timely access to affordable, preventive and curative health care of good quality (pillar 16) as well as the right to affordable long-term care services of good quality, in particular home-care and community-based services (pillar 18).47 arguably, by setting out a number of standards and principles, these international and regional (human rights) instruments call attention to state obligations to realize health rights for all and at all times. essentially, they bring into play an overarching framework primarily directed to state action, namely, requiring states to move their actions towards a greater focus on universal health care reforms, with an immediate and ultimate goal of complying with their health obligations and achieving optimum health for all, while effectively tackling the challenge of inequality. in fact, it is within this context that who pointedly notes that universal health coverage “is, by definition, a practical expression of the concern for health equity and the right to health.”48 hence, a crucial and pressing question remains as to how such a concern is addressed in the national context. iv. lessons from european realities in its long history, europe has the oldest human rights system whose aim is to uphold respect for human rights, democracy, fundamental freedoms, and the rule of law.49 in relation to health and health care, all eu countries are parties to at 43. 2012 o.j. (c 326/02) 402. of note, the charter became legally binding with the entry into force of the treaty of lisbon on december 1, 2009. 44. 2012 o.j. (c 326/01) 122. 45. communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions: establishing the european pillar of social rights, com (2017) 250 final (apr. 26, 2017). 46. id. at 4. see also 2017 o.j. (c 428/09). 47. c 428, supra note 46, at 14. 48. positioning health in the post-2015 development agenda: who discussion paper, world health org. 3 (oct. 2012), https://www.who.int/topics/millennium_development_ goals/post2015/whodiscussionpaper_october2012.pdf [https://perma.cc/s5xx-ck9q]. 49. see henry j. steiner, philip alston & ryan goodman, international human rights in contextlaw, politics and morals, 925-27 (oxford univ. press 3rd. ed. 2008). 2020] lessons from europe 73 least one legally binding human rights treaty which guarantees a right to health (care) for every individual. over the years they have enacted several pieces of national legislation that promoted the development of the traditional welfare state model in europe.50 interestingly, from very early on, health care reform efforts have been an issue of policy concern at the council of europe level. for instance, in its 1626 recommendation, the parliamentary assembly of the council pointedly stressed that “the main criterion for judging the success of health system reforms should be effective access to health care for all without discrimination, which is a basic human right. this also has the consequence of improving the general standard of health and welfare of the entire population.”51 nevertheless, despite important steps forward to universal health coverage of health insurance or national health systems, europe seems to be moving away from the language of human rights commitment—particularly of right to health commitment—to one of technical inputs and efficiency gains.52 indeed, austerity regimes have emerged in many european countries that build crisis-ridden health care reforms on an exclusive focus that largely lacks a rights perspective. admittedly, especially since the recent eurozone crisis, the national health policy agenda of several european countries has been dominated by calls for curtailing public health care expenditure, de-listing medical services from social insurance packages, health care privatization, and cost-shifting to patients.53 indeed, during the early years of the eurozone crisis, the european countries worst hit by the crisis (e.g., greece, and portugal), entered into financial assistance programs in the form of memorandum of understandings (mous). these involved, inter alia, the adoption of substantial health care reforms largely associated with radical reductions in public expenditures for social services.54 for instance, in the case of greece, the state generated a number of health care reform measures at the expense of equality in health and health care with major impact on the health system of the country—wedded to universal health care under law 1397/1983.55 see generally aart hendriks, the council of europe and health and human rights, health and human rights in europe, 23-50 (brigit toebes et. al. eds., 2012). 50. for instance, all european union countries are parties to the icescr. see international covenant on economic, social and cultural rights, united nations treaty collection, h t t ps :/ / t r ea t i e s . un .org/pages /viewdeta i l s . aspx?s rc=treaty&mtdsg_no=iv3&chapter=4&clang=_en [https://perma.cc/s8rl-qu5h]. see, e.g., alexiadou, supra note 18, at 53-55. see generally pierre pestieau, the welfare state in the european union: economic and social perspectives (2006). 51. eur. parl. ass., recommendation 1626: the reform of health care systems in europe: reconciling equity, quality and efficiency, 30th sess., ¶ 4 (2003). 52. see european comm’n expert panel on effective ways of investing in health, supra note 1, at 37. 53. id. see health law: solidarity and justice in health care, 7-14 (a.p. den exter ed., 2008). 54. see european commi’n expert panel on effective ways of investing in health, supra note 1, at 39-40. 55. alexiadou, supra note 18, at 171-202. 74 indiana health law review [vol. 17:63 principally, the public expenditure on health drastically curtailed; public healthcare facilities (i.e., public hospitals and rehabilitation care units), even though merged, remained critically understaffed and underfunded; increased co-payments and high prices in medicines were imposed; welfare programs reduced, seriously threatening the sustainability of social policies that provided a safety net towards certain vulnerable groups in society, often disadvantaged in terms of health outcomes and service coverage.56 as a consequence, the overall function of the public health system further deteriorated, placing an excessive burden on healthcare availability and accessibility.57 notably, in terms of per capita health spending, greece faced four consecutive reductions from 2009 onwards, namely -10.9% in 2009-10, 2.8% in 2010-11, -12.2% in 2011-12, -2.5% in 2012-13.58 surprisingly though, in 2013, parallel to the imposition of several health care austerity measures and in response to the european policy for health and well-being, health 2020—and perhaps given the implications of widening inequalities in access to health care—greece decided to seek the assistance of who. its intention was to reform its health system in order to actually achieve universal access to high-quality health services; with the explicit attention to the extremely poor and disadvantaged as well as with primary health care to be the cornerstone of this national reform initiative.59 at the same time, another noticeable shift that occurred in several european countries pertains to the proliferation of health sector privatization. the growing public health care costs in europe compounded by a conjunction of demographic (european population aging), economic (long-lasting recession), and technological (medical advances) challenges immensely pushed privatization in health sector provision forward.60 in the case of the netherlands, for example, from 2006 onwards, imposed health care reform measures concerned the restructuring of the country’s health system through the introduction of a decentralized private health insurance system with regulated competition—under the supervision by independent authorities—while ensuring universal coverage with subsidies for poor and vulnerable groups. particularly, health insurance companies were transformed into private entities, selectively contracting with health care providers with the 56. id. see, e.g., comm. on elimination of racial discrimination, concluding observations on the twentieth to twenty-second periodic reports of greece, ¶¶ 6-7, u.n. doc cerd/c/grc/co/20-22 (2016). see generally giannis sakellis, social protection in annual report 2010greek ombudsman, 57-75 (2010) https://www.synigoros.gr/resources/docs/ annual_2010.pdf. 57. id. 58. org. econ. coop. & dev., focus on health spending – oecd health statistics 2015 4 (2015), https://www.oecd.org/health/health-systems/focus-health-spending-2015.pdf [https://perma.cc/b772-9psn]. 59. see who, greece sign agreement on support programme for health reform, world health org. reg’l off. europe (feb. 7, 2013), http://www.euro.who.int/en/countries/greece/ news/news/2013/07/who,-greece-sign-agreement-on-support-programme-for-health-reform [https://perma.cc/6h5q-686y]. 60. see health law: solidarity and justice in health care, supra note 53. 2020] lessons from europe 75 intention of cost-containment and maximizing efficiency.61 in a similar vein, since 2006 sweden has undergone significant market-oriented health care reforms through the gradual sell/transfer of public hospitals and primary health care services to private providers.62 the preceding analysis invites the following observations in relation to the nature and scope of system reforms developed across europe over the course of the last years. crucially, european countries tend to adopt health care reforms mostly involving deep public health care budget cuts, the imposition of cost-containment measures on social welfare and health, and the gradual transfer of health care services to the private sector, while at the same time retaining universal health coverage at least in principle. in a way, the calls for imposing mainly economic reform measures (market-based reforms)—at the expense of tackling socioeconomic health inequalities that exist across european countries and regions as well as between population groups, as previously mentioned—highly reveal the weaknesses of european health systems in responding to a variety of pressures and challenges in accordance with human rights commitments. even though not all the implications of the imposed health care reforms are yet known, it is clear that the growing concern about poorer households and socially disadvantaged groups in europe has not been yet matched by comprehensive national reform efforts. some steps have been taken towards alleviating (financial) hardships (e.g. in the form of state subsidies), but affordable and equitable access to health care is still lacking and more must be done. meanwhile, it is plausible to discern that these predominantly crisis-ridden health care reforms do not reflect a progression but tend to cause a regression in the realization of health rights, which is of major concern from a human rights perspective and requires more considered state attention to challenge its key elements. essentially, as emerged from the analysis, the imposed health care reforms signal dangers for the ability of individuals and groups to exercise their right to health, while at the same time, aggravate existing inequalities by placing disproportionate (financial) barriers to health care access for poor and socially disadvantaged groups that are often vulnerable in terms of health outcomes and coverage. in fact, health care reforms based on the privatization of health care provision have raised a human rights concern in that the choice of privatization as a health care reform measure can be detrimental to the equitable availability and accessibility of health care, especially when this reform initiative is poorly conceived and under-regulated by a state.63 nonetheless, it must be conceded that regulated health sector privatization with substantial and sustained insurance subsidization for disadvantaged groups in society is possible to create a window 61. see generally brigit toebes & maite san giorgi, dutch realities: evaluating health care reform in the netherlands from a human rights perspective, in the right to health: a multi-country study of law, policy and practice 403-436 (brigit toebes et al. eds., 2014). 62. see göran dahlgren, neoliberal reforms in swedish primary health care: for whom and for what purpose?, 38 int’l j. health serv. 697 (2008). 63. u.n. secretary general, right of everyone to the enjoyment of the highest attainable standard of physical and mental health, ¶ 3, u.n. doc a/67/302 (aug. 13, 2012). 76 indiana health law review [vol. 17:63 of opportunity to cover inefficiencies in the public health sector, such as to enhance timely access to quality health care.64 overall, irrespective of differences in reform patterns, legal traditions, cultures, political context and resource capacities, concrete lessons can be learned from the experiences of european countries that could be relevant to other countries worldwide, facing health inequalities and health system deficiencies. undoubtedly, european realities call for a state focus on taking these lessons forward with the twin aim of protecting and enhancing population health while guaranteeing universal health coverage and substantive equality in access to health care for every individual. v. conclusions: looking ahead from the preceding analysis, it can be observed that the nature and scope of health care reform measures and especially their adherence to human rights standards constitute a significant determinant of equitable access to health care. in fact, framing health care reform measures in a manner inconsistent with human rights standards contributes to the reproduction of inequality in health and health care, predominantly harming poor and socially excluded households whose voices are often not heard and whose pressing health needs are not met. to remedy this disturbing trend in increasingly diverse societies, states should shift the focus of their attention to the inclusion of pressing health needs and challenges of all social classes and especially marginalized ones in the formulation and implementation of their health care reforms. to this aim, a system needs to be set up that ensures that imposed health care reforms reach the goal of universal coverage on the one hand and system efficiency on the other. this requires the adoption of a national framework law: (i) articulating stringent and salient human rights standards that will serve as guideposts for the deliberations about the nature and scope of health care reform measures by directing priority attention to the most vulnerable in society; and (ii) identifying tangible human rights commitments to be implemented by all responsible health sector actors, state, and non-state actors, so as to be employed by individuals and/or groups as a means for redress once their health rights are violated.65 nonetheless, it must be conceded that human rights standards do not provide easy solutions on health care reform choices, while no “one-size-fits-all” planning approach is available that will be achieved at once. looking ahead, it is therefore essential that the performance of any national health care reform effort be continuously monitored, evaluated and informed by discrete national realities, pressing needs and challenges, for the states to ensure that health care reform practices take due account of human rights norms; are sensitive to national circumstances (e.g., socioeconomic health inequalities, poverty); and are neither exclusively profit-driven nor crisis-ridden, but resilient to deal with existing and future crises and challenges. indeed, as eleanor kinney has pointedly argued more 64. alexiadou, supra note 18, at 206. 65. see alexiadou, supra note 18, at 295-300. 2020] lessons from europe 77 than a decade ago “the international human rights to health . . . arguably impose greater obligations on the united states and other nations with respect to health than we currently appreciate or recognize”.66 with this in mind and without doubt, the lesson seems to be that when explicit human rights commitments and effective state action coincide—in other words when there is a robust political will to do so—the enactment of substantial health care reforms to the benefit of society is possible. 66. see eleanor d. kinney, the international human right to health: what does this mean for our nation and world?, 34 ind. l. rev. 1475 (2001). repurposing the affirmative defense of comparative fault in medical malpractice cases to improve patient safety mindy nunez duffourc* “the problem is not bad people; the problem is that the system needs to be made safer.”1 i. introduction the typical defendants in u.s. medical malpractice lawsuits are healthcare providers targeted for individual acts of negligence, either directly or through the doctrine of respondeat superior. however, according to the institute of medicine (“iom”), blaming an individual does little to prevent medical errors and improve patient safety, because most errors can only be prevented by identifying and resolving systemic failures.2 although individual provider negligence should be, and is, addressed through the tort system, healthcare organizations are rarely held accountable for acts of systemic or organizational negligence. as a result, the malpractice system fails to promote the systemic change in healthcare organizations needed to improve patient safety. theoretically, the u.s. tort system allows injured patients to allege a cause of action against healthcare providers for organizational negligence. practically, patients suffer from a power imbalance against healthcare organizations that inhibits their ability to obtain evidence of systemic negligence. unlike plaintiffs, the individual provider defendants have insight into and the ability to prove organizational negligence. by asserting an affirmative defense of comparative negligence against the healthcare organization, individual defendant providers can accomplish five goals: (1) decrease their share of responsibility, (2) assure accountability of all responsible tortfeasors, (3) expose systemic causes of treatment errors, (4) deter organizational negligence, and (5) promote the replacement of individual-focused blame culture in healthcare with organizationfocused safety culture. of course, asserting a comparative fault affirmative defense based upon organizational negligence does not come without practical and doctrinal complications. practical complications include statutes of limitations’ effect on the plaintiff’s ability to recover damages from organizational actors, evidentiary * j.d., lecturer and ph.d. candidate at university of passau school of law. financial assistance was provided by the alexander von humboldt foundation’s german chancellor fellowship program and the chair of common law and the university of passau school of law. a preliminary version of this article was presented and the inaugural younger scholars’ forum during the 2018 international academy of comparative law’s xxth international congress in fukuoka, japan. 1. inst. of medicine, to err is human: building a safer health system 49 (linda t. kohn et al. eds., 2000). 2. id. at 56. http://doi.org/10.18060/3911.0053 22 indiana health law review [vol. 16:21 difficulties caused by peer-review statutes, and employment and insurance consequences that might deter an individual provider from blaming the healthcare organization. however, some jurisdictions have created judicial and legislative solutions to these practical problems that can restore the goals promoted by exposing organizational errors through affirmative defenses. doctrinal complications include issues of legal causation introduced by superseding causes and the maintenance of joint and several liability in some jurisdictions. to address problems of legal causation that stem from the seeming remoteness of organizational negligence to the patient’s injury, the restatement (second) of torts helps define the scope of liability amongst joint tortfeasors. in terms of joint and several liability, the modern trend toward damages allocation based on comparative fault encourages affirmative defenses also based on comparative fault. part ii of this article introduces the error research relied upon by the iom in its 1999 “to err is human: building a safer health system” report. it provides the theoretical foundation for the iom’s endorsement of a medical error prevention strategy that shifts the focus from individual providers to healthcare organizations. part iii discusses the jurisprudential evolution of medical malpractice law that enables a modern litigant to allege a direct cause of action against a healthcare organization. it includes a discussion of recognized theories of liability against healthcare organizations under the corporate negligence doctrine and proof problems that plaintiffs encounter when asserting those claims. finally, part iv part proposes a new legal strategy for holding healthcare organizations responsible for negligence in medical malpractice litigation through the defendant provider’s assertion of an affirmative defense of comparative fault, including an analysis of the practical and doctrinal complications that arise. ii. organizational negligence as a cause of medical errors historically, medical error prevention was solely focused on improving the skills of the individual provider. the idea that errors can be avoided if the offending individuals are more skilled, more attentive, more motivated, and more thorough permeates not only the healthcare culture, but also the legal system and popular opinion.3 while this focus on individual skill is not wrong, a comprehensive approach to preventing treatment errors also requires providers to detect and prevent systemic weaknesses. according to the institute of medicine, most errors are caused by systemic problems, not individual providers, and blaming an individual does little to prevent errors and improve patient safety.4 the iom found that psychologist james reason’s error research, which explains why damage-causing failures occur in complex systems, including 3. see id. at 42-43 (citing a study finding that the public associates medical errors with provider incompetence, carelessness, stress, and exhaustion). 4. see id. at 55-56 (explaining why errors occur and why punishing individuals is not an effective way to prevent errors). 2018] repurposing the affirmative defense of comparative fault 23 aviation and nuclear power, could also be used to understand medical errors.5 reason’s “swiss cheese model,” recognizes that complex system failures are usually the result of multiple weaknesses in the process chain.6 these weaknesses, called “latent failures,” do not individually cause damage.7 however, latent failures acting together can lead to damage at the end of the process chain.8 when damage occurs, the final error, which reason terms the “triggering event” or “active failure,” is easily identified, while the latent failures go unnoticed.9 as predicted by reason’s swiss cheese model, when failures occur in a healthcare system, an individual provider’s actions or inactions (active errors) are easily identified following a patient injury. as a result, individual providers become the targets of medical malpractice litigation, while the systemic failures go unnoticed and unaddressed.10 according to the iom, isolation of individual provider negligence as the cause of the patient injury will not effectively prevent future errors, because (1) the provider’s negligence can be caused or induced by a combination of latent errors unlikely to repeat, and (2) failing to address the latent errors allows them to accumulate making the system more error-prone.11 likewise, targeting only individual providers in medical malpractice litigation fails to identify latent errors, fails to hold healthcare organizations accountable for systemic failures, and promotes a culture of individual blame in healthcare, all of which threaten patient safety.12 iii. suing the organization in order for a private law cause of action to accrue for damages caused by negligent medical treatment, the following must exist: (1) a duty of care owed by the defendant to the plaintiff, (2) a breach of that duty, (3) causation, and (4) 5. see id. at 51-55. 6. see james reason, human error: models and management, 320 bmj 768, 769 (2000), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1117770/pdf/768.pdf [https://perma.cc/a9n2cuzq] (discussing the swiss cheese model of system accidents). 7. see id.; inst. of medicine supra note 1, at 55-57 (discussing latent errors and active errors). 8. reason, supra note 6, at 769; inst. of medicine, supra note 1, at 55-57 (discussing latent failures and active errors). 9. reason, supra note 6, at 769. 10. see sonja barth, aus fehlern lernen schwachstellen im system rechtzeitig erkennen [learn from errorsidentifying weaknesses in the system at an early stage], berliner ärzte, jan. 2009, at 17 https://www.aerztekammer-berlin.de/10arzt/40_qualitaetssicherung/50_ patientensicherheit/artikel_bae_1_2009_patientensicherheit.pdf [https://perma.cc/d2e5-t3gu] (discussing the application of reason’s human error research to the healthcare industry). 11. inst. of medicine, supra note 1, at 55-56. 12. see id. at 19-21 (recognizing that an error prevention strategy that shifted the focus from individual providers to healthcare organizations involved aligning factors external to the healthcare environment, including the legal system). 24 indiana health law review [vol. 16:21 damages.13 the duty owed by an individual provider to a patient generally stems from the provider-patient relationship.14 this duty is breached when the healthcare provider deviates from a recognized standard of medical care.15 the question of whether a healthcare organization, primarily the hospital, can be sued for medical malpractice hinges upon whether the hospital owes the patient a duty of care independent of the duty owed by the individual healthcare providers. historically, hospitals enjoyed immunity from liability stemming from negligent medical care.16 this insulation from liability was rooted in beliefs that hospitals merely provided facilities for medical practitioners to provide treatment, that hospitals could not control the actions of specialized healthcare providers, that hospitals could not practice medicine, and that only the physician as “captain of the ship” could be held responsible for negligent care.17 however, this legal view of hospitals as non-active participants in the provision of medical care began to change in 1957 when the new york court of appeals in bing v. thunig paved the way for hospital liability based on the negligence of its healthcare provider employees through the doctrine respondeat superior. the court articulated a modern view of hospitals: the conception that the hospital does not undertake to treat the patient, does not undertake to act through its doctors and nurses, but undertakes instead simply to procure them to act upon their own responsibility, no longer reflects the fact. present-day hospitals, as their manner of operation plainly demonstrates, do far more than furnish facilities for treatment. they regularly employ on a salary basis a large staff of physicians, nurses and internes, as well as administrative and manual workers, and they charge patients for medical care and treatment, collecting for such services, if necessary, by legal action. certainly, the person who avails himself of “hospital facilities” expects that the hospital will attempt to cure him, not that it nurses or other employees will act on their own responsibility.18 the bing court cleared the path for hospital liability stemming from the actions (or inactions) of individual healthcare providers through vicarious liability. while 13. elam v. coll. park hosp., 132 cal. app. 3d 332, 338 (cal. ct. app. 1982); jennings v. badgett, 230 p.3d 861, 865 (okla. 2010) (discussing the elements of a medical malpractice claim in the u.s). 14. west v. huxol, 135 f. supp. 3d 590, 597 (w.d. ky. 2015); roberts v. salmi, 866 n.w.2d 460, 466 (mich. ct. app. 2014) (finding that the duty owed by the health professional arises from the health professional’s relationship with the patient). 15. russell v. may, 400 p.3d 647, 657 (kan. 2017) (finding that the physician’s duty to the patient obligates him to use a certain standard of care). 16. see mitchell j. wiet, darling v. charleston community memorial hospital and its legacy, 14 annals health l. 399 (2005). 17. see cassandra p. priestley, hospital liability for the negligence of independent contractors: a summary of trends, 50 j. mo. b. 263, 263 (1994). 18. bing v. thunig, 143 n.e.2d 3, 8 (n.y. 1957). 2018] repurposing the affirmative defense of comparative fault 25 the doctrine of respondeat superior was a means of holding the hospital vicariously liable for its employees’ actions, it generally excluded vicarious liability for negligent acts of independent contractor physicians.19 the doctrines of estoppel and apparent agency served as vehicles for vicarious hospital liability in the absence of an employment relationship between the hospital and the doctor.20 pursuant to these doctrines, the court looked at whether the hospital represented itself as a full-service provider of medical care inducing the patient to believe that the hospital, rather than the individual healthcare providers, was responsible for their care.21 the concept of hospital liability outside of the vicarious liability doctrines would not emerge until 1965, eight years after the bing court expressed its view that hospitals play a direct role in delivery in healthcare. the illinois supreme court in darling v. charleston community memorial hospital redefined the legal relationship between hospitals and patients.22 the court, citing bing’s view of modern hospitals, recognized for the first time a legal cause of action for negligence based upon a duty owed by the hospital directly to the patient rather than one that was imputed through the doctrine of respondeat superior.23 in darling, the court allowed the jury to determine whether the hospital breached its duty to the patient by failing to ensure the adequacy and competency of its nursing staff, failing to review the patient’s treatment while at the hospital, and failing to require necessary consultation.24 additionally, the darling court sanctioned the use of industry accreditation standards, state-licensing standards, and the hospital’s own regulations to determine the applicable legal standard of care owed by the hospital.25 the most important of these standards is the joint commission on accreditation of healthcare organizations accreditation (“jcaho’s”) manual, which is used by courts to evaluate the applicable standard of care in corporate negligence claims.26 darling had answered the question of whether hospitals in illinois owed patients a direct duty of care with a resounding yes, and the doctrine of corporate negligence was born.27 over the next half-century, other jurisdictions followed in darling’s footsteps requiring hospitals to exercise reasonable care while providing healthcare services to patients under the corporate negligence 19. see priestly, supra note 17, at 264. 20. see id. at 265. 21. see id. 22. darling v. charleston cmty. mem’l hosp., 200 n.e.2d 149 (ill. app. 1964), aff’d, 211 n.e.2d 253 (ill. 1965). 23. id. 24. id. 25. see wiet, supra note 16, at 407. 26. see kerry a. kearney & edward l. mccord, hospital management faces new liabilities, 6 health law., no. 3, fall 1992, at 1, 3. 27. see wiet, supra note 16, at 407-08. 26 indiana health law review [vol. 16:21 doctrine.28 a. theories of liability under the corporate negligence doctrine the elements of a prima facie case of corporate negligence are: (1) derivation from an accepted standard of care, (2) actual or constructive notice of the defects or procedures that created the harm, and (3) negligent conduct that was a substantial factor in bringing about the plaintiff’s harm.29 the scope of the corporate negligence doctrine is generally limited to actions that involve administrative and managerial decisions, as opposed to medical decisions; however, courts and legislatures in different states have interpreted the scope of the doctrine in varying degrees.30 the doctrine encompasses duties to select and retain competent physicians, maintain appropriate facilities and equipment, train and supervise employees, and implement appropriate protocols and procedures.31 1. the duty to exercise due care in physician credentialing decisions jurisdictions that recognize a theory of negligence under negligent credentialing impose a duty to exercise reasonable care in the selection and continued monitoring of physicians seeking staff privileges. “this duty requires a hospital to examine the qualifications of any physician seeking staff privileges and to limit the physician’s practice to those procedures for which the physician is qualified.”32 the hospitals’ duty to select and retain competent physicians is based upon the concept that hospitals, which control physicians’ hospital privileges, are in the best position to protect patients from incompetent physician 28. see id.; see kearney & mccord, supra note 26, at 1 (noting in 1992 that 22 states had adopted some form of corporate liability). 29. see 3 summary pa. juris. 2d torts § 37:45 (2d ed.), westlaw (database updated july 2018); see also yvonne k. puig, liability overview: new theories and challenges (2001) (seminar materials citing welsh v. bulger, 698 a.2d 581, 585 (pa. 1997)), http://archive. healthlawyers.org/google/health_law_archive/program_papers/2001_hospitals/%5b2001_ hospitals%5d%20liability%20overview-%20new%20theories%20and%20challenge.pdf/ [https://perma.cc/kpq8-95xw]. 30. see essig v. advocate bromenn med. ctr., 33 n.e.3d 288, 303 (ill. 4 dist. ct. app. 2015) (“ordinarily, the hospital’s institutional duty of care is ‘administrative or managerial in character.’”). 31. see generally s. allan adelman & julie robertson, emerging trends in healthcare liability (june 19, 2000), http://archive.healthlawyers.org/google/health_law_archive/program_ papers/2000_am/%5b2000_am%5d%20emerging%20trends%20in%20healthcare%20liabi lity.pdf [http://perma.cc/q8vg-6fxf]; puig, supra note 29; 3 summary pa. juris. 2d torts § 37:45 (2d ed.), westlaw (database updated july 2018) (discussing theories of direct hospital liability). 32. colleen k. sanson, cause of action against hospital for negligent selection or supervision of medical staff member, in 32 causes of action 2d 1 §6 (december 2018 update). 2018] repurposing the affirmative defense of comparative fault 27 care.33 because it is common for staff physicians with hospital privileges to be independent contractors, not employees, of the hospital, the tort of negligent credentialing provides a direct cause of action against the hospital for negligent provider actions outside of the respondeat superior framework. still, some jurisdictions limit or reject the tort of negligent credentialing.34 generally, in order to sustain a cause of action for negligent credentialing, the plaintiff must show: (1) the hospital had a duty to exercise due care in credentialing decisions, (2) the credentialed physician was incompetent or unfit and either should not have been credentialed or should have been subject to practice restrictions, (3) the hospital failed to exercise due care in its credentialing decision, (4) the physician committed malpractice that resulted in an injury, and (5) the hospital’s credentialing decision was a proximate cause of the injury.35 although the majority of corporate liability cases involve allegations of negligent physician credentialing, this is an unlikely basis for an individual provider to allege an affirmative defense of comparative fault against the hospital, since allegations of negligence against the doctor and the hospital are inextricably tied. 2. the duty to maintain competent staff closely connected to (and sometimes overlapping) a hospital’s duty to exercise due care in credentialing decisions is a duty to maintain competent staff. failure to maintain competent staff can include inadequate staffing, failure to monitor independent contractors, and failure to train and supervise employees. in kirby v. state ex rel. louisiana state university board of supervisors, the court the upheld a verdict finding that a hospital was “not competently staffed” when the decedent was only seen by an intern during a critical time in her care, there was no identifiable staff physician attending to the decedent, and the interns and residents were negligently supervised.36 in northern trust co. v. louis a. weiss memorial hospital, the finding of hospital liability was based upon a failure to have a specially-trained nurse in the nursery at all times.37 the duty to maintain competent staff has extended to contractor staffing corporations. in gray v. john r. vaughn, m.d., p.c., the court held an emergency room staffing company liable for failing to supervise triage nurses in violation of its contractual 33. see insinga v. labella, 543 so. 2d 209, 214 (fla. 1989). 34. see st. luke’s episcopal hosp. v. agbor, 952 s.w.2d 503 (tex. 1997) (limiting negligent credentialing claims to those that involve a showing of malice); mcvay v. rich, 874 p.2d 641 (kan. 1994) (holding that state statute bars negligent credentialing claim); svindland v. a.i. dupont hosp. for children of nemours found., no. 05-0417, 2006 wl 3209953 (e.d. pa. nov. 3, 2006) (finding that delaware’s peer review statute precludes negligent credentialing claim). 35. see sanson, supra note 32, at §3. 36. kirby v. state ex rel. la. state univ. bd. of supervisors, 174 so. 3d 1, 10 (la. app. 2014); see also darling v. charleston cmty. mem’l hosp., 200 n.e.2d 149 (ill. app. 1964) (upholding hospital liability based upon the inadequacy and incompetency of its medical staff.). 37. n. tr. co. v. louis a. weiss mem’l hosp., 493 n.e.2d 6 (ill. app. 1986). 28 indiana health law review [vol. 16:21 obligations.38 while some jurisdictions find that the duty to maintain competent staff includes the continued supervision of physicians who have been granted staff privileges, other jurisdictions have declined to impose liability on the hospital when the claim is centered upon a staff physician’s medical decision making. in greenwood v. wierdsma, 741 p.2d 1079 (wyo. 1987), a wyoming court allowed a cause of action against a hospital for failure to supervise staff physicians. however, in petratos v. markakis, an ohio court held that a hospital’s duty to grant staff privileges only to competent physicians did not require it to monitor or intervene in a staff physician’s medical care.39 similarly, an alabama court in coleman v. bessemer carraway methodist center declined to hold the hospital liable for the actions of a staff neurosurgeon under a negligent supervision theory in the absence of a negligent credentialing decision.40 3. the duty to maintain appropriate facilities and equipment both hospitals and hospital management companies have been found negligent for failure to exercise reasonable care in the maintenance of the hospital’s facilities and equipment.41 the duty to maintain adequate facilities and equipment requires hospitals to have the facilities and equipment necessary to safely carry out the medical treatment it offers.42 in hernandez v. smith, an obstetrical clinic without caesarean facilities breached this duty.43 in kirby, the court found a hospital negligent when a crash cart had neither a properly functioning ekg machine nor the right size endotracheal tube.44 the duty to provide adequate equipment and facilities does not require the hospital to employ the latest or best technology, but rather to provide equipment and facilities suited for their intended use and comparable to facilities and equipment used by other hospitals in the same community.45 in emory v. porter, 38. gray v. john r. vaughn, m.d., p.c., 460 s.e.2d 86, 87 (ga. ct. app. 1995). 39. petratos v. markakis, 637 n.e.2d 13, 14 (ohio ct. app. 1993). 40. coleman v. bessemer carraway methodist med. ctr., 589 so. 2d 703, 705 (ala. 1991) 41. see adelman & robertson, supra note 31 (liability imposed on hospital management company); but see united tort claimants v. quorum health res., llc (in re otero cty. hosp. ass’n), 527 b.r. 719 (bankr. d.n.m. 2015), on reconsideration in part, united tort claimants v. quorum health res., llc (in re otero cty. hosp. ass’n), 584 b.r. 783 (bankr. d.n.m. apr. 19, 2018) (corporate negligence doctrine does not extend to hospital management companies). 42. see adelman & robertson, supra note 31. 43. hernandez v. smith, 552 f.2d 142 (5th cir. 1977). 44. kirby v. state ex rel. la. state univ. bd. of supervisors, 174 so. 3d 1 (la. app. 2014). 45. see adelman & robertson, supra note 31; see also emory univ. v. porter, 103 ga. app. 752 (1961) (dismissing a claim of hospital negligence where although the hospital equipment in question was the newest model, there was no allegation that it was defective or not reasonably suited for its intended purpose); see also lauro v. travelers ins. co., 261 so.2d 261 (la. ct. app. 1972) (finding that a hospital’s duty is measured by the degree, care, and skill generally exercised by hospitals in the same community). 2018] repurposing the affirmative defense of comparative fault 29 the court dismissed a negligence claim against a hospital based upon the allegation that a defective incubator burned an infant finding that “[a]n appliance is not defective by reason of the failure to have incorporated therein the latest improvement or invention developed for its use.”46 however, if a hospital lacks the facilities and equipment necessary to treat a patient, it may have a duty to transfer the patient to another hospital.47 4. the duty to implement appropriate protocols, policies, and procedures some jurisdictions impose a duty on healthcare organizations to implement protocols, policies, and procedures to protect patient safety.48 this includes duties to ensure the safety and quality of medical care as well as safety and sanitation of the hospital’s buildings and grounds.49 texas courts have been particularly accepting of a theory of corporate negligence based upon policyand procedurebased duties. in air shields inc. v. spears, a texas court upheld the trial court’s finding that a hospital’s policies and procedures for administration of oxygen to premature infants was negligent.50 in denton regional medical center v. lacroix, a texas court found that a hospital could be liable for entering into a contract with an anesthesia provider that had negligent policies and procedures regarding certified registered nurse anesthetist (crna) supervision contrary to the hospital’s own policies.51 in chesser v. lifecare management services, a texas court found a hospital management company’s policies and procedures concerning a patient’s care plan were negligent.52 the chesser court explained the company’s duties as follows: lms had a duty to manage, control, direct, supervise, and evaluate the care, services, competence, and quality of care and services provided at hospital; a duty to create policies, procedures, bylaws, rules, and regulations that govern hospital; and a duty to ensure that the policies and procedures it implemented were in fact instituted and evaluated and that compliance was enforced by hospital.53 the duty to ensure adequate policies and procedures includes the duty to enforce existing policies. in williams v. st. claire medical center, a kentucky 46. emory univ., 103 ga. app. at 755. 47. see adelman & robertson, supra note 31. 48. see kearney & mccord, supra note 26, at 4 (identifying duties imposed by the corporate negligence doctrine). 49. see id (duty to formulate polices to ensure safety of medical care); see also sibley v. bd. of supervisors of la. state univ., 477 so.2d 1094, 1099 (la. 1985) (duty to have procedures to ensure safety of building and grounds). 50. air shields, inc. v. spears, 590 s.w.2d 574, 581 (tex. civ. app. 1979), reh’g denied. 51. denton reg’l med. ctr. v. lacroix, 947 s.w.2d 941, 956 (tex. app. 1997). 52. chesser v. lifecare mgmt. servs., l.l.c., 356 s.w.3d 613, 631 (tex. app. 2011). 53. id. 30 indiana health law review [vol. 16:21 court held that a hospital has a duty to properly administer its policies regardless of whether a patient was treated by an employee physician or a private staff physician.54 in johnson v. st. bernard hospital, an illinois court held that the hospital had a duty to assist physicians in obtaining an orthopedic consultation in accordance with its bylaws.55 the johnson court noted that the hospital has a duty to use administrative expertise to enforce rules and regulations that ensure patient safety.56 there has been some reluctance to pose a duty on hospitals to implement policies and procedures that govern independent physicians’ actions. in gafner v. down east community hospital, a maine court refused to judicially extend its corporate negligence doctrine to include a duty to develop policies that govern physicians’ medical decision-making. the court based its decision on the following: before the expansion of tort liability into an area that has been significantly controlled by the legislature, we should allow the legislature to address the policy considerations and determine whether imposing such a duty constitutes wise public policy . . . moreover, creating a duty on the part of hospitals to control the actions of those physicians who have traditionally been considered independent contractors may shift the nature of the medical care provided by those physicians. in an area as replete with the possibility of unexpected or unintended consequences as this, we should exercise restraint in the use of our authority to create new causes of action.57 maine’s reluctance to judicially extend its corporate negligence doctrine in gafner exemplifies a conservative interpretation of the corporate negligence doctrine’s scope. b. proof problems despite research showing the prominent role of organizational failures in medical errors and the availability of legal actions for holding the organization responsible, individual providers remain the primary targets of medical malpractice lawsuits. this is largely because it is easiest for the patient to prove the existence of a duty and breach by the individual healthcare provider from whom they directly received treatment. more difficult for the patient, is recognizing the existence of a duty and breach on behalf of the healthcare organization. unlike the individual provider, the healthcare organization does not enter into a physician-patient relationship with the patient. as discussed above, a plaintiff must show that the hospital had actual or constructive notice of the 54. williams v. st. claire med. ctr., 657 s.w.2d 590, 594 (ky. ct. app. 1983). 55. johnson v. st. bernard hosp., 399 n.e.2d 198, 205 (ill. app. 1979). 56. id. 57. gafner v. down e. cmty. hosp., 735 a.2d 969, 979-80 (me. 1999). 2018] repurposing the affirmative defense of comparative fault 31 problem to establish a prima facie case of corporate negligence.58 this burden places plaintiff, as an outsider to the system, at a significant disadvantage, one that can be alleviated by an individual provider’s allegation of organizational negligence pled through an affirmative defense of comparative fault. iv. comparative fault as an affirmative defense the comparative fault doctrine apportions liability among all parties such that each party is responsible only for the degree of damages caused by its negligence.59 comparative fault is a repudiation or, in a modified version, an abrogation, of the contributory negligence doctrine, which operates to bar a plaintiff’s recovery when the plaintiff’s own negligence caused their injuries.60 pure and modified versions of comparative fault have gained near universal acceptance in the united states.61 as a result, defendants who seek to decrease their liability by pointing to negligence of other parties can assert an affirmative defense of comparative fault.62 through an affirmative defense of comparative fault, defendants can claim that any party or nonparty is responsible for at least some measure of a plaintiff’s damages.63 a defendant alleging comparative fault bears the burden of establishing that the other party owed a duty of care to the plaintiff, breached that duty, and that the breach caused the plaintiff’s injury.64 the restatement (third) of torts provides guidance for assigning percentages of liability to all negligent parties. it recommends the following factors be considered: (a) the nature of the person’s risk-creating conduct, including any awareness or indifference with respect to the risks created by the conduct 58. see priestly, supra note 17. 59. stuart m. speiser et al., american law of torts § 13:2 (3rd ed. 2018); see mccain v. howell, 971 so. 2d 323, 331 (la. ct. app. 2007) (stating the fact that more than one party can contribute to the harm is the reason for the comparative fault system). 60. see speiser et al., supra note 59. 61. see restatement (third) of torts: apportionment of liab. § 1 (am. law inst. 2000). 62. in re new eng. compounding pharm., inc. products liab. litig., 251 f. supp. 3d 294, 297-98 (d. mass. 2017). 63. see id.; see also johnson v. niagara mach. & tool works, 666 f.2d 1223, 1226 (8th cir. 1981) (allowing submission of nonparty fault to jury under comparative negligence rules). 64. see hinshaw v. united states, 264 f. supp. 3d 1026 (d. ariz. 2017) (holding that the defendant bears the burden of proof on an affirmative defense of comparative fault); willis v. noble drilling (united state), inc., 105 so. 3d 828, 841-42 (la. app. 5th cir. 2012) (finding that a defendant who pleads nonparty fault must prove this claim by a preponderance); see also in re new eng. compounding pharm., inc. products liab. litig., 251 f. supp. 3d 294, 297-98 (d. mass. 2017) (delineating the elements of a prima facie claim of negligence for purposes of establishing a comparative fault defense). 32 indiana health law review [vol. 16:21 and any intent with respect to the harm created by the conduct; and (b) the strength of the causal connection between the person’s riskcreating conduct and the harm.65 comment c to the restatement further explains that the nature of risk creating conduct includes, “such things as how unreasonable the conduct was under the circumstances, the extent to which the conduct failed to meet the applicable legal standard, the circumstances surrounding the conduct, each person’s abilities and disabilities, and each person’s awareness, intent, or indifference with respect to the risks.”66 in order to ensure the “equitable and efficient administration of a comparative fault system,” the plaintiff must have ability to hold negligent nonparty actors responsible for damages they cause.67 to accomplish this goal, many states have incorporated a notice requirement into their comparative fault schemes. tennessee rule of civil procedure 8.03 requires parties alleging comparative fault to identify or describe the other tortfeasor and give a short and plain statement of the facts constituting fault on which the defendant relies. in free v. carnesale, the court found a medical malpractice defendant’s answer insufficient to plead an affirmative defense of comparative fault under tennessee’s law when it merely stated that any negligence was not the fault of the defendant but failed to affirmatively plead nonparty fault and identify the nonparty.68 michigan law requires the defendant to “designate the nonparty and set forth the nonparty’s name and last known address, or the best identification of the nonparty that is possible, together with a brief statement of the basis for believing the nonparty is at fault.”69 florida and indiana impose similar notice requirements.70 these notice requirements serve to balance “two competing principles: the principle that every person injured by another person or persons has the right to be fully compensated for the harm, and the principle that those who cause a particular harm should only be responsible for his or her share in producing the harm.”71 65. restatement (third) of torts: apportionment of liab. § 8 (am. law inst. 2000). 66. id. cmt. c. 67. see george v. alexander, 931 s.w.2d 517, 522 (tenn. 1996) (holding that a defendant in a medical malpractice case could not shift blame to another actor without giving plaintiff notice by pleading an affirmative defense of nonparty fault). 68. free v. carnesale, 110 f.3d 1227, 1230-31 (6th cir. 1997); see tenn. r. civ. p. 8.03. 69. mich. ct. r. 2.112. 70. see vila v. philip morris usa inc., 215 so. 3d 82, 86 (fla. 3d dist. app. 2016) (holding that a defense nonparty fault must be plead as an affirmative defense that identifies the nonparty); see cornell harbison excavating, inc. v. may, 546 n.e.2d 1186, 1187 (ind. 1989) (holding that indiana law requires defendants to plead nonparty fault and specifically identify the allegedly negligent nonparty). 71. taylor v. michigan petroleum techs., inc., 859 n.w.2d 715, 719 (mich. app. 2014); see also cornell harbison excavating, inc. v. may, 546 n.e.2d 1186, 1187 (ind. 1989) (the indiana legislature, “sacrificed a true apportionment of damages among all tortfeasors in favor of 2018] repurposing the affirmative defense of comparative fault 33 if medical malpractice defendants take on the burden of proving organizational negligence through an affirmative defense of comparative fault, the plaintiff will have access to a new theory of negligence of which she might not have otherwise been aware or able to prove. unlike plaintiffs, the individual provider defendants not only have insight into the organization’s negligent actions, but also access to sources of proof, which can include the individual provider’s own testimony. by asserting an affirmative defense of comparative negligence against the healthcare organization, individual defendant providers can accomplish five goals: (1) decrease their share of responsibility, (2) assure accountability of all responsible tortfeasors, (3) expose systemic causes of treatment errors, (4) deter organizational negligence, and (5) promote the replacement of individual-focused blame culture in healthcare with organizationfocused safety culture. of course, asserting a comparative fault affirmative defense based upon organizational negligence does not come without practical and doctrinal complications. a. practical complications statutes of limitations and peer-review statutes introduce practical complications that can undermine the goals of asserting an affirmative defense of comparative negligence against healthcare organizations. in addition, employment and insurance circumstances surrounding the individual provider’s medical practice can also introduce obstacles. nevertheless, some jurisdictions have enacted judicial and legislative solutions to these practical problems that can serve as models. 1. statute of limitations in cases where an affirmative defense is pled after the statute of limitations against the nonparty provider has expired, the goals of assuring accountability of all responsible tortfeasors and deterring organizational negligence could be lost. the general relation back rules governing plaintiff’s ability to add a new party in an amended complaint do not allow the plaintiff to add a new party against whom the statute of limitations has run unless the law specifically allows relation back or the newly added party: (1) received notice of the action such that it would not be prejudiced and (2) knew or should have known that but for a mistake concerning its identify, the action would have been brought against it.72 in a lawsuit that originally alleged the negligence of an individual provider for breaching the standard of medical care, the addition of the healthcare organization as a new party under a theory of organizational negligence does not fit within the usual relation back framework. maximizing recovery by the injured plaintiff where the nonparty cannot be identified.”). 72. fed. r. civ. p. 15(c). although the majority of medical malpractice cases are litigated in state court, the federal rules of civil procedure often serve as a model for the state rules. 34 indiana health law review [vol. 16:21 some states have avoided the statute of limitations problem by providing statutory authority for plaintiffs to add parties identified in a defendant’s defense of comparative negligence against a nonparty. the michigan court of appeals addressed the policy reasons for abrogating the state’s statute of limitations in cases of nonparty comparative negligence: by permitting the allocation of liability to nonparties, the legislature decreased the risk that a particular defendant would be required to pay compensation for another party’s share of the harm caused to the plaintiff, but increased the risk that the plaintiff would not receive full compensation for his or her injuries. this might occur when the plaintiff learns about a nonparty’s role during discovery, but after the passage of the period of limitations. to mitigate the risk that an injured party would not be fully compensated, the legislature provided plaintiffs with an opportunity to amend their complaints to include those nonparties who are identified during the course of the litigation and further provided that the amendment would be deemed timely if the claims would have been timely had the plaintiffs included them in their original complaints. accordingly, with the enactment of mcl 600.2957(2), the legislature made a clear policy choice in favor of allowing a plaintiff to amend his or her complaint to include a nonparty within 91 days of the “identification of [the] nonparty” and have that amendment relate back to the filing of the original complaint for purposes of the applicable period of limitations.73 similarly, tennessee law provides a 90-day window for a plaintiff to add a nonparty against whom the original defendant has alleged comparative fault provided that the original defendant was timely sued.74 indiana law sets time limitations on a defendant’s ability to plead nonparty fault as an affirmative defense, such that “plaintiffs will usually have an opportunity to add the nonparty as a party defendant in order to preserve the right to recover against it.”75 the louisiana medical malpractice act (mma) suspends the one-year prescriptive period (statute of limitations) for all joint tortfeasors when a plaintiff files a timely request for review of a medical malpractice claim against a healthcare provider.76 this suspension operates against joint tortfeasors that are qualified or non-qualified healthcare providers under the mma, as well as nonhealthcare providers.77 on the other hand, malpractice plaintiffs are not entitled 73. taylor v. mich. petroleum techs., inc., 859 n.w.2d 715, 719–20 (mich. app. 2014) (citing trentadue v. gorton, 738 n.w.2d 664 (mich. 2007). 74. tenn. code ann. § 20-1-119. 75. huber v. henley, 656 f. supp. 508, 510 (s.d. ind. 1987). 76. see la. stat. ann. § 9:5628 (2010) (setting prescriptive periods for medical malpractice); la. stat. ann. § 40:1231.8 (2017) (suspending prescription in medical malpractice cases). 77. see milbert v. answering bureau, inc., 120 so.3d 678 (la. 2013) (finding that the mma’s prescription provisions applied to physician answering service). 2018] repurposing the affirmative defense of comparative fault 35 to benefit from the general code provision interrupting prescriptions for all tortfeasors upon timely filing of a suit against one joint tortfeasor.78 under the mma, prescription begins to run again ninety days after the parties receive notification from the medical review panel opinion or notification that the named healthcare provider is not qualified under the act.79 as a result, plaintiffs have to react quickly to add a party in response to an affirmative defense against a nonparty, although they would presumably have enough information from the panel process, during which discovery is allowed, to name potentially negligent healthcare organizations in the original lawsuit. one way for a plaintiff to avoid statute of limitation problems that can arise from an affirmative defense of nonparty comparative fault is to add the healthcare organization as a defendant in the original complaint. since the name of the hospital or organization at which plaintiff received treatment is generally known at the time of filing, plaintiffs could, as a matter of course, name the organization and allege one or more of the organizational negligence theories discussed supra. 2. peer review peer review statutes, which protect information developed by hospital peer review committees from discovery, also introduce evidentiary obstacles in organizational negligence claims.80 while the scope of peer review privileges varies by jurisdiction, peer review statutes have been introduced in nearly every state.81 the goal of peer-review statutes is to improve healthcare quality by allowing critical analysis of adverse events without fear of medical malpractice litigation.82 while peer review statutes serve an important role in patient safety, they have also forced courts to reconcile peer review protections with corporate negligence doctrines. minnesota, ohio, and wyoming courts have all considered whether their state peer review statutes’ confidentiality provisions precluded claims of negligent credentialing, and they have unanimously responded that they do not.83 in response to hospitals’ claims that the peer review confidentiality provisions would preclude the hospital from access to evidence needed to defend negligent credentialing claims, namely the information used by the credentialing committee 78. see lebreton v. rabito, 714 so. 2d 1226 (la. 1998) (finding that the mma’s prescription provisions apply to the exclusion of the general prescription provisions in the civil code). 79. la. stat. ann. § 40:1231.8 (2017). 80. see kenneth r. kohlberg, the medical peer review privilege: a linchpin for patient safety measures, 86 mass. l. rev. 157 (2002). 81. id. 82. id.; see generally eid v. loyola u. med. ctr., 72 n.e.3d 851 (ill. app. ct.), appeal denied, 84 n.e.3d 363 (ill. 2017) (finding that hospital investigation into child’s death was protected by the state’s peer review statute in organizational negligence claim). 83. see larson v. wasemiller, 738 n.w.2d 300 (minn. 2007); browning v. burt, 613 n.e.2d 993, 1007 (ohio 1993); greenwood v. wierdsma, 741 p.2d 1079, 1088 (wyo. 1987). 36 indiana health law review [vol. 16:21 to make a credentialing decision, the courts noted that the peer review protections excluded information used by the committee but obtained from original sources or information considered within a person’s knowledge.84 the evidentiary difficulty that arises from peer review confidentiality does not affect plaintiffs and defendants equally. the larson court recognized that while hospitals might be able to identify original sources or witnesses with personal knowledge to defend negligent credentialing claims, the patient, who bears the burden of proof, would be at a greater evidentiary disadvantage.85 a california court in mt. diablo hospital medical center v. superior court, defended this disadvantage to the patient finding that the state’s peer review statute “evinced a legislative judgment that the quality of in-hospital medical practice would be elevated by giving staff inquiries a measure of confidentiality, even though such confidentiality exacts a social cost by impairing malpractice plaintiffs’ access to evidence.”86 although, as discussed supra, an individual provider is unlikely to allege an affirmative defense of negligent credentialing, the courts’ harmonization of the peer review and corporate negligence doctrines can be equally applied to other organizational negligence theories. in these scenarios, the organization’s negligence rests upon what it knew or should have known about inadequate staffing, policies, or equipment at the time of the plaintiff’s injury. as such, although a peer-review committee might be convened to discuss the reasons for the final injury-causing error subsequent to the injury, the relevant sources of proof against the organization would relate to prior actions and information that lie outside of the peer-review analysis. it is in the ability to identify and access these sources of proof that individual providers maintain a significant advantage over patients. 3. employment and insurance considerations individual providers may be hesitant to allege a claim of comparative fault against the healthcare organization in which they work for fear of negative employment consequences. this concern is amplified when the individual provider is an employee of the healthcare organization and is covered under the organization’s insurance policy. conflicts of interest that arise as a result of 84. see larson v. wasemiller, 738 n.w.2d 300 (minn. 2007); browning v. burt, 613 n.e.2d 993, 1007 (ohio 1993); greenwood v. wierdsma, 741 p.2d 1079, 1088 (wyo. 1987). 85. larson, 738 n.w.2d at 310 (“the difficulty of proof may fall most heavily on the patients because the effect of the statute is to preclude the discovery of what evidence was actually obtained by the hospital in the credentialing process, and the patients bear the burden of proof on negligence.”). 86. mt. diablo hosp. med. ctr. v. super. ct., 204 cal. rptr. 626 (ct. app. 1984) (holding that “proceedings” and “records” of a peer-review committee were protected from discovery in negligent credentialing case); but see brown v. super. ct., 214 cal. rptr. 266 (ct. app. 1985) (holding that whether a hospital evaluated its physicians was discoverable since that information is not considered “proceedings” and “records” of a peer-review committee). 2018] repurposing the affirmative defense of comparative fault 37 alleging theories of negligence adverse to the hospital can complicate matters further because the insurance company is required to assign separate attorneys for the individual provider and the hospital, increasing the cost of defense.87 although the defendant provider has a right to allege any available defenses, including an affirmative defense of organizational negligence, the organization, the insurance company, and their attorneys may have influence to discourage the individual provider from pointing the finger at the organization. on the other hand, if the individual provider is covered under a separate insurance policy, the provider’s insurer and attorney have incentive to decrease the provider’s share of liability by exploring potential bases for organizational negligence in an affirmative defense. b. doctrinal complications issues of legal causation expose doctrinal complications of alleging an affirmative defense of comparative fault against healthcare organizations. however, the restatement (second) of torts provides workable solutions for these duty-risk complications by clarifying the scope of liability among joint tortfeasors. in addition, while joint and several liability schemes can undermine the goal of holding each defendant responsible only for its own negligence, the modern trend replacing joint and several liability with a comparative fault damages allocation system encourages affirmative defenses of comparative fault. 1. causation an affirmative defense based upon organizational negligence entails duty-risk complications. defenses to legal causation based upon superseding (or intervening) causes are convenient for healthcare organizations to allege, because the individual provider’s negligence is usually more recognizable and temporally connected to the plaintiff’s damages than the organization’s negligence.88 the restatement (second) of torts defines an intervening act as one that produces harm to another person subsequent to a negligent act committed by an earlier actor.89 when an intervening act prevents the earlier actor, whose negligence was a substantial factor in bringing about the harm, from being liable 87. see generally brown v. peninsula hosp. ctr., 407 n.y.s.2d 586, 587 (app. div. 1978) (“[t]he hospital’s former attorneys breached their duty under the code of professional responsibility to inform the doctor of the potential conflict of interest”). 88. see puckett v. mt. carmel reg’l med. ctr., 228 p.3d 1048, 1060 (kan. 2010) (noting that superseding causes are defenses to legal causation, which considers the foreseeability of an action’s risk of harm and the nature of the harm caused, as opposed to cause in fact, commonly referred to as “but-for” causation). 89. restatement (second) of torts: intervening force defined § 441 (am. law inst. 1965). 38 indiana health law review [vol. 16:21 for the harm, the intervening act is a superseding cause.90 the comparative negligence doctrine does not eliminate defenses to causation based upon superseding causes.91 in response to an affirmative defense of comparative negligence against it, a healthcare organization may argue that the individual’s provider’s medical malpractice was a superseding cause of a plaintiff’s injuries, especially if the organizational negligence alleged involves administrative decisions are remote in time and not easily connected to the provider’s act of malpractice. the restatement (second) provides guidance to help courts determine whether intervening actions are superseding causes. since healthcare organizations will generally point to the individual provider’s alleged negligence as a superseding cause, it is important to first note that the fact that the intervening act is an act of negligence itself does not make it a superseding cause if the prior actor should have anticipated the negligent intervening act or if the intervening act was a “normal consequence of the situation created” by the prior actor and is not “extraordinarily negligent.”92 other considerations in determining whether an intervening act is a superseding cause include: (a) the fact that its intervention brings about harm different in kind from that which would otherwise have resulted from the actor’s negligence; (b) the fact that its operation or the consequences thereof appear after the event to be extraordinary rather than normal in view of the circumstances existing at the time of its operation; (c) the fact that the intervening force is operating independently of any situation created by the actor’s negligence, or, on the other hand, is or is not a normal result of such a situation; (d) the fact that the operation of the intervening force is due to a third person’s act or to his failure to act; (e) the fact that the intervening force is due to an act of a third person which is wrongful toward the other and as such subjects the third person to liability to him; (f) the degree of culpability of a wrongful act of a third person which sets the intervening force in motion.93 in the context of medical malpractice cases, these considerations weigh against finding that the individual provider’s negligence is a superseding cause to the organization’s negligence. 90. id. § 440. 91. see puckett v. mt. carmel reg’l med. ctr., 228 p.3d 1048, 1061-62 (kan. 2010) (superseding and intervening cause doctrines survive the adoption of comparative negligence); borne v. celadon trucking services, inc., 532 s.w.3d 274 (tenn. 2017) (proximate cause and intervening cause remain jury questions in the comparative fault decision-making process). 92. restatement (second) of torts: negligence of intervening acts § 447 (am. law inst. 1965). 93. id. § 442. 2018] repurposing the affirmative defense of comparative fault 39 in addition, there is a strong body of medical malpractice case law to suggest that a subsequent provider’s negligence will rarely be considered a superseding cause under the principles set forth in the restatement.94 in puckett v. mt. carmel regional medical center, the court found that the negligent acts of subsequent healthcare providers were not superseding causes of the patient’s injury, but rather, under the principles of legal causation, were concurring causes that required allocation under the state’s comparative fault doctrine.95 the puckett court cited to similar holdings from alabama, california, iowa, oklahoma, texas, and virginia courts, all of which found that the negligence of multiple healthcare providers should be assessed under the comparative fault rules.96 consideration of a third person’s failure to prevent harm, like that of intervening acts, can impact legal causation by creating a superseding cause. however, the restatement (second) forecloses the ability of negligent actor to be relieved from liability when a subsequent actor fails to prevent the harm caused by the first actor’s negligence unless the duty to prevent harm has completely shifted from the first actor to the subsequent actor.97 the concept of failure to prevent harm can be attractive to healthcare organizations defending a claim of organizational negligence in cases where the individual’s provider’s alleged negligence is based upon a failure to act, for example, failure to diagnose a medical condition. the comments to the restatement explain that liability is only avoided based upon third party’s failure to prevent harm in “exceptional cases,” for example, when there is an express agreement between the two parties to shift responsibility.98 comment f provides factors for determining when a complete shift in responsibility can occur, including, the degree of danger and the magnitude of the risk of harm, the character and position of the third person who is to take the responsibility, his knowledge of the danger and the likelihood that he will or will not exercise proper care, his relation to the plaintiff or to the defendant, the lapse of time, and perhaps other considerations.99 in looney v. davis, the court, applying the restatement, found that a defendant dentist was not entitled to allege a superseding cause defense based upon an allegation that negligent emergency room physicians failed to prevent harm initially caused by his negligent dental care.100 the looney court focused 94. puckett v. mt. carmel reg’l med. ctr., 228 p.3d 1048 (kan. 2010) (“[i]t is only in extraordinary cases that there is an intervening cause.”). 95. id. at 1063. 96. id. at 1063-64. 97. restatement (second) of torts: third person’s failure to prevent harm § 452 (am. law inst. 1965). 98. id., cmts. d, e. 99. id., cmt. f. 100. looney v. davis, 721 so. 2d 152 (ala. 1998); but see siggers v. barlow, 906 f.2d 241 40 indiana health law review [vol. 16:21 on the foreseeability of the plaintiff’s death from the defendant dentist’s original act of negligence. although the possibility of a causation defense based upon the failure of the individual provider to prevent the patient harm is not foreclosed in medical malpractice cases, it would only be successful in “extraordinary cases” and should not discourage providers from alleging an affirmative defense of comparative negligence against a negligent healthcare organization. 2. joint and several liability while a successful affirmative defense would decrease the individual provider’s percentage of negligence by the percentage of the organization’s negligence, joint and several liability schemes would deprive the individual provider from receiving a corresponding decrease in responsibility for the overall judgment amount by holding each tortfeasor responsible for the entire amount of plaintiff’s damages. although the modern trend is to replace joint and several liability with comparative damages allocation schemes that limit a plaintiff’s recovery from each defendant to the extent of the defendant’s fault, some states have specifically exempted medical malpractice from their comparative fault rules. for example, indiana has excluded medical malpractice actions from its comparative fault law in favor of allowing the common law defense of contributory negligence instead.101 likewise, michigan declines to apply comparative fault damages allocation in medical malpractice cases, instead favoring several liability for medical malpractice defendants in cases where the plaintiff is not contributorily negligent.102 on the other hand, louisiana applies its comparative-fault law equally to all theories of liability, including those based on medical malpractice.103 even in the face of joint and several liability, which is applied in a minority of u.s. jurisdictions, individual providers’ natural compulsion to defend their care and increase overall safety for patients should provide sufficient motivation for exposing organizational errors through a comparative fault affirmative defense. v. conclusion an individual’s healthcare provider’s assertion of comparative fault against a healthcare organization for organizational negligence provides potential for (6th cir. 1990) (finding that responsibility shifted from physician who misdiagnosed x-rays to emergency room physician who was aware misdiagnosis but failed to inform treatment such that the misdiagnosing physician was relieved from liability under the restatement’s failure to prevent harm principles.). 101. palmer v. comprehensive neurologic servs., p.c., 864 n.e.2d 1093 (ind. ct. app. 2007). 102. keith a. braswell et al., 18a mich. civ. jur. negligence §112 (2018). 103. dumas v. state ex rel. dep’t of culture, recreation & tourism, 828 so. 2d 530 (la. 2002). 2018] repurposing the affirmative defense of comparative fault 41 immediate benefits to the individual provider and long-term benefits to patient safety that outweigh the practical and doctrinal complications that discourage such a defense. the ability of healthcare providers to refocus the discussion of medical errors in medical malpractice lawsuits to include organizational errors is in line with the modern error prevention research and can provide one practical step towards promoting systemic learning and patient safety. mindy nunez duffourc* the intersection of harm reduction and zoning law: a growing divide between nimbys and public health initiatives gavin p. hunter* i. introduction walking into fayette county’s courthouse in eastern indiana, one would expect to find the normal sights and sounds of a courthouse—attorneys preparing for trial, clerks assisting individuals, and judges in their chambers. however, the fayette county courthouse offers something found in only nine of indiana’s ninety-two counties: a syringe exchange program (“sep”).1 located in the courthouse’s basement, this program offers vital services to people fighting substance use disorder, such as clean needles, needle disposal, hiv and hepatitis c testing, naloxone to prevent overdose death, fentanyl test strips, immunizations and medical care, and referrals to drug treatment centers.2 programs such as fayette county’s sep only became legal in indiana in 2018, following the passage of indiana house bill 1438, which allows a county to create a sep.3 even with a legal path to the creation of seps, only nine counties in indiana now operate such a program.4 although considerable progress has been made in indiana to reduce the harm of substance use disorder, there are still counties unwilling to provide individuals with these life-changing and lifesaving services. a. the issue: zoning boards bending to the will of nimbys nimbyism is a powerful attitude within communities. standing for “not in my back yard,” nimby denotes a local effort to oppose changing the status quo within the locale.5 it often rears its ugly head in opposition to social justice initiatives such as public housing projects or drug treatment facilities.6 too often, nimbys can influence a community’s decisions and sway public opinion, proving detrimental to initiatives aiming to better a community. seps and other types of harm reduction sites have been the victims of * j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.b.a., 2019, grand valley state university. a special thank you to professor aila hoss and professor susan demaine for all their help on this note. 1. giles bruce, conservative indiana adopted needle exchanges but still faces local resistance, kaiser health news (feb. 12, 2020), https://khn.org/news/conservative-indianaadopted-needle-exchanges-but-still-faces-local-resistance [https://perma.cc/bz4p-w2sv]. 2. id. 3. h.b. 1438, 120th gen. assemb., first reg. sess. (ind. 2017). 4. bruce, supra note 1. 5. peter d. kinder, not in my backyard phenomenon, britannica, https://www. britannica.com/topic/not-in-my-backyard-phenomenon [https://perma.cc/lj7u-5sed] (last visited oct. 4, 2020). 6. id. 482 indiana health law review [vol. 19:481 decision making dominated by nimbys for too long. harm reduction is a public health strategy aimed at reducing the harms associated with certain behaviors such as intravenous drug use.7 often, the proposed creation of harm reduction sites carries a stigma, usually due to fears as to how crime rates and real estate prices will be affected.8 nimbys typically claim that a harm reduction site will actually encourage more drug use within the community.9 as has been proven numerous times, however, this claim is unfounded and without statistical support.10 as public health departments and local health officials continue to work at mitigating the effects of the opioid epidemic and other public health crises, nimbys are proving to be a formidable hurdle to harm reduction initiatives. although nimby’s may voice loud opposition to the creation of a harm reduction site within their community, the will of nimbys is often most evident at public zoning hearings when a harm reduction initiative has been proposed in a community.11 zoning boards hold a tremendous amount of power within a community and can often be the deciding factor in whether a harm reduction site, such as a syringe exchange program or safe consumption site, will come to fruition.12 it is imperative that zoning boards not bend in the face of nimbyism, as access to these public health programs must take precedence over fear. b. indiana should preempt zoning boards from acting in this manner in order to facilitate public health initiatives and reduce the impact of the opioid crisis on indiana, the state legislature should preempt local zoning boards from caving to public pressure. specifically, zoning boards should not be allowed to create barriers to harm reduction sites such as requiring an arbitrary amount of community approval.13 moreover, the indiana legislature should pass a law designating spot zoning as illegal per se to ensure that it is not continuing behind closed doors.14 this will help express that indiana will not tolerate discriminatory 7. see karen mary leslie, harm reduction: an approach to reducing risky health behaviours in adolescents, 13 can. paediatric soc’y 53 (2008). 8. elana gordon, what's the evidence that supervised drug injection sites save lives?, nat’l pub. radio (sept. 7, 2018, 2:40 pm), https://www.npr.org/sections/health-shots/2018/09/07/ 645609248/whats-the-eviden ce-th a t -su pervised-drug-in jection-sites-save-lives [https://perma.cc/93bn-9a5e]. 9. id. 10. see jonathan berr, philadelphia was supposed to open the first u.s. safe injection site. residents and officials are pushing back, bisnow (mar. 15, 2020), https://www.bisnow.com/ philadelphia/news/commercial-real-estate/future-of-philadelphia-safe-injection-site-in-doubt103360 [https://perma.cc/p5m9-dtz4]; see also gordon, supra note 8. 11. see id. 12. see id. 13. see vill. of euclid, ohio v. ambler realty co., 272 u.s. 365, 395 (1926). 14. see scalambrino v. town of michiana shores, 904 n.e.2d 673, 682 (ind. ct. app. 2009) (citing hundt v. costello, 480 n.e.2d 284, 285 (ind. ct. app. 1985)). 2022] the intersection of harm reduction and zoning law 483 zoning practices that promote unfounded negative stereotypes and stigmas. when the mission of a community initiative is to further the public health and general welfare, zoning ordinances should not be denied based on a false claim to better support public health. nimbys often argue that the implementation of harm reduction strategies or the creation of a harm reduction site will lead to a rise in crime within the area, a rise in drug use within the community, or a decline in real estate values.15 these claims are unsubstantiated and do not hold up under statistically rigorous scrutiny.16 a harm reduction facility, whether it be a syringe exchange program or safe consumption site, furthers public health and counters the effects of substance use disorder within a community. therefore, it is irrational to declare a harm reduction facility invalid by law or deny a zoning ordinance on grounds that such a facility is a detriment to public health. this note discusses the impact of zoning law on public health initiatives involving harm reduction through the creation of seps and safe consumption sites. section ii of this note provides background information on harm reduction and its importance, as well as explaining what seps and safe consumption sites are, and how they further public health initiatives and are affected through zoning law. section iii provides a brief history of zoning law and its intersection with public health. this includes an analysis of the supreme court case that declared zoning as a constitutional practice, an explanation of current indiana zoning law, and an examination of how zoning law can affect public health outcomes. section iv examines a case study of how zoning laws affected public health initiatives within indiana and offer solutions to supplement the progress that has already been made. finally, section v analyzes the complications involving zoning that must be addressed to further harm reduction with regards to opioid use disorder. ii. background: a public health issue a. public health issue: overdoses, infectious diseases, and death with the advent of new medical technologies and studies, it is now known that substance abuse harm goes beyond what was previously understood. for example, while infectious disease has long been linked to intravenous drug use, new research suggests that intravenous drug use can also cause damage to the vascular system and increase the likelihood of a pseudoaneurysm.17 drug use, both licit and illicit, can affect the body in different ways, in both the short and long term.18 the harms resulting from drug use may be affected by 15. see berr, supra note 10. 16. see gordon, supra note 8. 17. see ayse nur bardak et al., foot drop with a popliteal artery aneurysm due to heroin use: a case report, 64 turkish j. physical med. & rehab. 284 (2018). 18. health consequences of drug misuse, nat’l inst. on drug abuse, https://www. drugabuse.gov/drug-topics/health-consequences-drug-misuse/introduction [https://perma.cc/jq7l37rv] (last visited nov. 8, 2020). 484 indiana health law review [vol. 19:481 the type and amount of drug used, the manner in which the drug is used, duration of usage, and the user’s health and genetics.19 short-term effects of drug use can cause irregular heartbeat, disruption of neurotransmitters, impaired cognitive ability, and in extreme cases, death.20 long-term effects can include heart disease, lung disease, and cancer, if the drug is inhaled.21 if the drug is consumed intravenously through the use of unclean needles, the user may be at risk of developing hiv, hepatitis, and other communicable diseases.22 moreover, drug use can lead to substance use disorder.23 substance use disorder is a disorder of the brain and can change the way an individual acts or thinks due to alterations of brain structure and function. substance use disorder can prove fatal as well, as drug overdose often leads to death.24 additionally, drug use can have indirect effects on the lives of the user, and on the lives of those close to them. drug use can affect an individual’s decisionmaking or impulsivity control.25 drug use and substance use disorder can also lead to more substantial negative outcomes such as damaging an individual’s educational performance, employment status, and personal relationships. it can also, of course, expose the individual to the criminal justice system through enforcement of criminalizing substance and paraphernalia possession.26 b. solutions: harm reduction, syringe exchange programs, and safe consumption sites 1. harm reduction in general, harm reduction is a public health strategy aimed at reducing the harms associated with certain behaviors.27 harm reduction approaches can be applied to a multitude of public health issues and can be simple or exceptionally complex. for example, harm reduction can be as simple as wearing a seat belt when riding in a vehicle.28 harm reduction can also be used to reduce the rates of 19. id. 20. see methamphetamine research report: what are the immediate (short-term) effects of methamphetamine misuse?, nat’l inst. on drug abuse (oct. 2019), https://www.drugabuse. gov/publications/research-reports/methamphetamine/what-are-immediate-short-term-effectsmethamphetamine-misuse [https://perma.cc/7d4t-956s]; see also what are the short-term effects of drug use?, above the influence, https://abovetheinfluence.com/faq/what-are-the-short-termeffects-of-drug-use/ [https://perma.cc/jyl8-g4xg] (last visited feb. 17, 2021). 21. health consequences of drug misuse, supra note 18. 22. see id. 23. id. 24. id. 25. id. 26. id. 27. see leslie, supra note 7. 28. see harm reduction, recovery rsch. inst., https://www.recoveryanswers.org/resource/ drug-and-alcohol-harm-reduction/ [https://perma.cc/b9y6-b3e9] (last visited feb. 17, 2021). 2022] the intersection of harm reduction and zoning law 485 teenage pregnancy and the spread of sexually transmitted infection through a robust sex education program and access to birth control.29 more specifically, harm reduction applied to substance use disorder seeks to reduce the adverse consequences involved with using harmful substances.30 the national harm reduction coalition has set forth numerous principles they consider to be central to the practice of harm reduction in communities.31 these principles focus primarily on accepting that drug use is part of society and that solving the problems associated with the use of substances is incredibly complex and will require a diverse array of solutions.32 additionally, the coalition asserts that providing non-judgmental and non-coercive services must be provided to people who use drugs in order to further reduce harms.33 it is often the case that harm reduction facilities are the only place in a community where people who use drugs can be greeted with compassion instead of contempt.34 many of the individuals who visit these facilities are at the end of their rope, and the compassion provided to them at harm reduction sites can be the first step toward recovery.35 harm reduction positions itself in direct contrast to a disciplinary approach to substance use.36 advocates of harm reduction strategies may often find themselves in direct conflict with the criminal justice system, choosing a more compassionate strategy, focusing on human dignity, instead of a punitive one.37 despite the differences, harm reduction strategies have begun to permeate the criminal justice system. in november of 2020, voters in the state of oregon approved a ballot measure to decriminalize possession of small amounts of narcotics including cocaine, heroin, oxycodone, and methamphetamines.38 if found in possession of a small amount of these substances, the individual will instead be subject to a civil violation and fine instead of criminal charges.39 29. see leslie, supra note 7. 30. see id. 31. principles of harm reduction, nat’l harm reduction coal., https://harmreduction. org/about-us/principles-of-harm-reduction/ [https://perma.cc/bpk3-bxzr] (last visited nov. 8, 2020). 32. id. 33. id. 34. see bruce, supra note 1. 35. see id. 36. see harm reduction, drug pol’y all., https://drugpolicy.org/issues/harm-reduction [https://perma.cc/9vyw-j4uy] (last visited feb. 17, 2021). 37. see id. 38. cleve r. wootson jr. & jaclyn peiser, oregon decriminalizes possession of hard drugs, as four other states legalize recreational marijuana, wash. post (nov. 4, 2020), https://www. washingtonpost.com/nation/2020/11/04/election-drugs-oregon-new-jersey/ [https://perma.cc/38wz6lul]. 39. amelia templeton, measure 110 would make oregon 1st state to decriminalize drug use, or. pub. broad. (oct. 14, 2020), https://www.opb.org/article/2020/10/15/measure-110486 indiana health law review [vol. 19:481 additionally, the individual can avoid the fine by participating in a health assessment aimed at incentivizing the individual to enter a substance use treatment facility.40 2. syringe exchange programs long used in europe, syringe exchange programs are quickly catching on in the united states as a way to mitigate and even prevent the negative effects of intravenous drug use in the wake of the opioid epidemic.41 these programs allow individuals to exchange or dispose of used needles for clean ones without risking criminal liability.42 use of clean needles helps deter the spread of communicable diseases such as hiv and hepatitis c.43 additionally, these programs provide much more than just clean needles. seps often offer testing for communicable diseases, overdose-reversal drugs, fentanyl test strips, immunizations, and referrals to drug treatment organizations.44 it is in these expanded offerings that the importance of these programs can be seen. although primarily focused on reducing the rate of communicable diseases transmitted by intravenous drug use, seps take a wider view of the many different health issues associated with substance use disorder. as a result, seps have recently found more support from state legislatures.45 as of 2019, thirtyeight states including alaska, arizona, california, colorado, connecticut, delaware, florida, georgia, hawaii, idaho, illinois, indiana, kentucky, louisiana, maryland, massachusetts, maine, michigan, minnesota, montana, north carolina, north dakota, new hampshire, new jersey, new mexico, nevada, new york, ohio, oregon, pennsylvania, rhode island, tennessee, utah, virginia, vermont, washington, wisconsin, west virginia, and the district of columbia allowed needle exchanges statewide or locally.46 according to the centers for disease control (“cdc”), nearly thirty years of research shows that “comprehensive seps are safe, effective, and cost-saving, do not increase illegal drug use or crime, and plan an important role in reducing the transmission of viral hepatitis, hiv, and other infections.”47 additionally, oergon-politics-decriminalize-drugs/ [https://perma.cc/ex2y-ecuh?type=image]. 40. id. 41. see victoria knight, needle exchanges find new champions among republicans, kaiser health news (may 9, 2019), https://khn.org/news/needle-exchanges-find-newchampions-among-republicans/ [https://perma.cc/ba38-yhvv]. 42. bruce, supra note 1. 43. id. 44. id. 45. see knight, supra note 41; see also syringe exchange program legality, found. aids rsch., https://opioid.amfar.org/indicator/ssp_legality# [https://perma.cc/z9ct-6hh2] (last visited feb. 17, 2021). 46. see knight, supra note 41. 47. syringe services programs (ssps), ctr. disease control & prevention, https://www. cdc.gov/ssp/index.html [https://perma.cc/r8wj-pv7e] (last updated may 23, 2019). 2022] the intersection of harm reduction and zoning law 487 research shows that individuals who are new users of a sep are five times more likely to enter a program for drug treatment and approximately three times more likely to stop using drugs than individuals who do not take advantage of sep programs.48 while a majority of these programs are funded at the state and local level, appropriations language from congress for the years 2016 through 2018 permitted the use of funds from the department of health and human services to support local seps, with the caveat that the funds were not used to purchase syringes.49 however, even with the federal funding from congress, authority to create and decisions about the use of seps remain primarily at the state and local level.50 3. safe consumption sites unlike syringe exchange programs, safe consumption sites have only recently been considered as a harm reduction strategy within the united states, putting us far behind other countries. the first safe consumption site in north america opened in 2003 in vancouver, canada two decades ago.51 approximately 120 legally sanctioned supervised consumption sites operate in eleven countries around the globe.52 along with canada, australia, germany and switzerland also have safe consumption sites operating legally within their borders.53 safe consumption sites are locations where drug users can inject an illegal substance in a safe, clean, medically monitored environment.54 this ensures that the individual will have proper medical attention in the event of an overdose, potentially saving a life,55 and allows both the user and the public greater peace of mind.56 similar to syringe exchange programs, safe consumption sites are not only focused on preventing overdose deaths, but they also help reduce hiv and hepatitis risk, and provide individuals with information on and access to treatment facilities.57 according to research cited by the american medical association: 48. summary of information on the safety and effectiveness of syringe services programs (ssps), ctr. disease control & prevention, https://www.cdc.gov/ssp/syringe-servicesprograms-summary.html [https://perma.cc/78cc-n3bx] (last updated may 23, 2019). 49. id. 50. id. 51. gordon, supra note 8. 52. tanya albert henry, will the u.s. get its first supervised drug consumption site?, ama (dec. 15, 2020), https://www.ama-assn.org/delivering-care/opioids/will-us-get-its-firstsupervised-drug-consumption-site [https://perma.cc/a3v3-ckem]. 53. id. 54. gordon, supra note 8. 55. id. 56. id. 57. tom beck, the safe injection site fight is shaping up to be a battle between residents 488 indiana health law review [vol. 19:481 • 3,180 overdoses were reversed at a safe consumption site within germany between 2000 and 2013. • there has been a 68% drop in the number of opioid-related overdose calls in the area surrounding a supervised consumption site in sydney, australia. • and nearly 200,000 individuals have visited a safe consumption site in vancouver, canada with a recorded 6,440 overdose interventions.58 safe consumption sites are clearly saving lives and helping to reduce the effects of substance use within the surrounding community they serve. it is important to note that these safe consumption sites do not provide individuals with illicit substances, a caveat which has prompted numerous legal challenges within the united states in the form of governmental gridlock, lawsuits, and injunctions from the department of justice and state attorneygenerals.59 although there have been legal challenges to safe consumption sites, public health interest in them continues to grow in california, colorado, and pennsylvania.60 in 2019, a california bill awaiting the governor’s signature would have approved the founding of a safe consumption site in san francisco.61 however, the bill eventually stalled in the california state assembly.62 meanwhile, a proposed safe injection site in philadelphia continues to fight against nimbyism to achieve its mission of furthering public health.63 a. the battle for safehouse a more in-depth examination is needed to understand supervised consumption sites better and explore how legal hurdles have impacted harm and health experts, south philly rev. (mar. 17, 2020), https://southphillyreview.com/ 2020/03/17/the-safe-injection-site-fight-is-shaping-up-to-be-a-battle-between-residents-and-healthexperts/ [https://perma.cc/g3sj-mza4]. 58. henry, supra note 52. 59. united states v. safehouse, 408 f. supp. 3d 583, 587 (e.d. pa. 2019). 60. see supervised injection sites are coming to the united states: here’s what you should know, u. s. cal. dep’t nursing (may 2, 2019), https://nursing.usc.edu/blog/supervised-injectionsites/ [https://perma.cc/btk3-bb56]. 61. a.b. 362, 2019-20 reg. sess. (cal. 2019); see also gordon, supra note 8. 62. press release, san francisco aids foundation, supervised consumption bill ab 362 stalls; critical need for overdose prevention services continues (aug. 27, 2020), https://www. sfaf.org/collections/breaking-news/supervised-consumption-bill-ab-362-stalls-critical-need-foroverdose-prevention-services-continues/ [https://perma.cc/lx99-3v2p]. 63. see michaela winberg, safehouse drops south philly plans, looks to kensington after judge suspends launch, billypenn (june 26, 2020, 3:45 pm), https://billypenn.com/2020/ 06/26/safehouse-drops-south-philly-plans-looks-to-kensington-after-judge-suspends-launch/ [https://perma.cc/k84m-ltsv]. 2022] the intersection of harm reduction and zoning law 489 reduction in philadelphia and at the federal level. first enacted by congress in 1986, the federal “crack house” statute’s original draft criminalized certain drug crimes as part of the controlled substances act.64 it was further amended in 2003 to criminalize more modern drug crimes congress deemed a threat to the public.65 the statute provides that it shall be unlawful to “knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance.”66 moreover, the statute dictates that it shall also be unlawful to “manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.”67 the statute’s original draft in 1986 was concerned about “crack houses,” or places where crack cocaine and other drugs were manufactured and used, as well as other spaces or properties designed to facilitate drug use.68 in 2003, amendments to the statute added events such as “drug-fueled raves” where promoters of the event encourage the use of “club drugs.”69 with a shift towards public health approaches to substance use, the question is whether the crack house statute criminalizes safe consumption sites.70 some have used the statute to challenge the legality of safe consumption sites, particularly proposed safe consumption site facilities in san francisco, california and philadelphia, pennsylvania.71 the 2019 challenge to a proposed site in philadelphia is illustrative of the issues that arise under the federal “crack house” statute.72 in united states v. safehouse, the district court for the eastern district of pennsylvania held that safe consumption sites are not illegal under federal law as they are not being operated “for the purpose of” illegal drug use.73 although the presence of illegal drugs in safehouse’s facilities is undisputed, the court held that a plain reading of the statute indicates that it is not meant to cover properties whose primary purpose is to reduce the use of illegal drugs:74 “an action taken ‘for the purpose of’ unlawful drug use would therefore refer to a purpose of facilitating drug use, 64. united states v. safehouse, 408 f. supp. 3d 583, 591 (e.d. pa. 2019). 65. id. at 592. 66. 21 u.s.c. § 856(a)(1). 67. id.; see also § 856(a)(2). 68. safehouse, 408 f. supp. 3d at 613. 69. id. at 611. 70. id. at 591. 71. see generally safehouse, 408 f. supp. 3d 583; see also gordon, supra note 8. 72. see generally safehouse, 408 f. supp. 3d 583. 73. id. at 587. 74. id. at 608. 490 indiana health law review [vol. 19:481 not an effort to reduce drug use.”75 as the court so eloquently pointed out, it is safehouse’s mission to reduce drug use and the harms associated with it.76 as 21 u.s.c. § 856 was designed to criminalize the use of a facility for the manufacture, use of drugs, or encouragement of the use of drugs, the statute could not logically apply to safehouse.77 furthermore, the court acknowledged that when § 856 was last amended in 2003, the question of safe consumption sites had not yet entered the realm of public debate in the united states.78 at that time in 2003, insite, canada’s first safe consumption site, had just opened in vancouver.79 it would be odd for congress to be including an amendment that had not become the subject of public debate within the united states. as the court reasoned further, it would be in derogation of congress’s intent to apply the federal “crack house” statute to a medical facility that had not even been considered by congress at the time of the statute’s drafting.80 the safehouse case did not simply end with the decision of the eastern district court. following the decision by the court, a grotesque display of the nimbyism that pervades throughout local government was on display for the nation in philadelphia. further analysis of nimbyism and its effects will occur later in this note. further discussion on how nimbyism affected safehouse will take place in section iv. 4. harm reduction in indiana in early 2015, the indiana state department of health (“isdh”) began an investigation into an outbreak of eleven cases of hiv in scott county in southeast indiana.81 this outbreak was anomalous as, historically, scott county reported fewer than five hiv cases annually.82 it would later be discovered that this hiv outbreak was tied to needle sharing for the injection of intravenous drugs among members of the community.83 by april 2015, the isdh diagnosed 135 individuals, out of the 4,000-person community, with hiv. of these 135 individuals, 80% reported injecting drugs.84 following the discovery of this hiv outbreak, a public health emergency was 75. id. at 609. 76. id. 77. id. at 613. 78. id. at 615-16. 79. gordon, supra note 8. 80. safehouse, 408 f. supp. 3d at 616-17. 81. see caitlin conrad et al., community outbreak of hiv infection linked to injection drug use of oxymorphone — indiana, 2015, 64 ctr. disease control & prevention morbidity & mortality wkly. rep. 443 (2015). 82. see id. 83. see id. 84. see id. 2022] the intersection of harm reduction and zoning law 491 declared by executive order.85 then-governor mike pence authorized a provisional needle exchange program in order to curb the spread of hiv throughout the state.86 however, the initial needle exchange programs faced challenges throughout indiana. pence himself opposed such programs, defending his belief by asserting the age-old stigma that such programs further perpetuated drug use within a community.87 other individuals displayed biases about hiv, with one scott county resident still clinging to the false notion that “[i]t was a homosexual disease.”88 in the wake of the 2015 hiv outbreak, the indiana state legislature passed public law 198-2017, allowing counties to establish syringe exchange programs.89 under the provisions of this law, a qualified entity may operate a program in a county or municipality when: (1) a public health emergency has been declared; (2) there is an epidemic of hiv or hepatitis c through intravenous drug use; and (3) the syringe exchange program is an appropriate medical response to the public health crisis.90 after the declaration of a public health emergency, the county or municipality must either conduct a public hearing before approving the program or submit a request for approval to the state health commissioner.91 even if a qualified program is approved by public hearing or the state health commissioner, the program must annually register with both the state and local health departments.92 in addition, the program must be overseen by a physician, registered nurse, or physician assistant.93 the program must store and dispose of all syringes in a safe and legal manner, provide education and training on drug overdose, and provide substance use disorder treatment information and referrals to drug treatment programs.94 as a result of the provisional seps created under public law 198-2017, substantial public health progress was made in indiana. from 2016 to 2017, drug overdose deaths in indiana rose by 22.5%.95 in contrast, from 2017, when public 85. see id. 86. abby goodnough, rural indiana struggles to contend with h.i.v. outbreak, n.y. times (may 5, 2015), https://www.nytimes.com/2015/05/06/us/rural-indiana-struggles-to-contend-withhiv-outbreak.html [https://perma.cc/94lh-rvlm]. 87. id. 88. id. 89. pub. l. 198-2017, 120th gen. assemb., reg. sess. (ind. 2017). 90. id. 91. id. 92. id. 93. id. 94. id. 95. 2016-2017 drug overdose death rate increases, ctr. disease control & prevention, https://www.cdc.gov/drugoverdose/data/statedeaths/drug-overdose-death-rateincrease-2016-2017.html [https://perma.cc/t7cz-ap3c] (last visited sept. 7, 2020). 492 indiana health law review [vol. 19:481 law 198-2017 was enacted, to 2018, drug overdose deaths dropped by 12.9%.96 it seems likely that this is attributable, at least in part, to the distribution of overdose medications and education and training on drug overdose at syringe exchange programs made possible by public law 198-2017.97 despite its success, public law 198-2017 was set to automatically expire in july 2021.98 members of the general assembly initially blocked a proposal that would have made authorization for the program permanent.99 instead, the general assembly simply extended authorization for another year to 2022 and delayed the issue for the next legislative session.100 finally, during april 2021, the general assembly finally found a temporary solution in the form of public law 1302021, which extends authorization for seps in indiana until 2026.101 although public law 130-2021 extends the authorization for seps in indiana more than the previous extensions, the solution is still only temporary.102 the general assembly must choose if it will take a proactive step to protect public health and harm protection in indiana, or if it will continue to simply kick the problem down the road to future legislative sessions. 5. the effectiveness of indiana harm reduction it is irrefutable that the effects of the opioid epidemic have been felt across the state of indiana. however, considerable progress has been made across the state combatting the effects of substance and opioid use disorder with the help of harm reduction strategies, particularly in scott county. in the wake of the outbreak, scott county created a community outreach center to promote harm reduction strategies.103 the outreach center provided not only testing for infectious diseases and a syringe exchange program but also provided insurance enrollment and job training for members of the community.104 these additional services provided solutions to issues that are linked to long term effects of substance and opioid use disorders, such as poverty. additionally, the sep in scott county has dispensed a staggering 613,534 96. id. 97. see h.b. 1438, 120th gen. assemb., first reg. sess. (ind. 2017); see also bruce, supra note 1. 98. pub. l. 198-2017, 120th gen. assemb., reg. sess. (ind. 2017). 99. eric berman, indiana extends needle exchange authority to 2026, wibc (april 12, 2021), https://www.wibc.com/news/local-indiana/indiana-extends-needle-exchange-authority-to2026/ [https://perma.cc/645x-pcst]. 100. pub. l. 112-2020, 121st gen. assemb., reg. sess. (ind. 2020). 101. pub. l. 130-2021, 122nd gen. assemb., reg. sess. (ind. 2021). 102. see pub. l. 198-2017, 120th gen. assemb., reg. sess. (ind. 2017); see also pub. l. 1122020; pub. l. 130-2021 (incrementally moving the authorization date for seps from 2021 to 2026). 103. joan duwve, mitigating the impact of opioid misuse and addiction on hoosiers, communities, and public health, ind. u. (apr. 23, 2019), https://scholarworks.iu.edu/dspace/ handle/2022/22976 [https://perma.cc/w244-e4v8]. 104. id. 2022] the intersection of harm reduction and zoning law 493 clean syringes from the period of 2015-2018.105 the sep has also had an astounding 566,630 syringes returned to the program.106 a study conducted of the behaviors of 124 people who injected drugs before and after the public health response to the hiv outbreak in scott county found that, of the 48 individuals who were hiv-positive, 47 (98%) used the sep for sterile syringes.107 in contrast, only 84%, or 53 out of 65 hiv-negative individuals observed, used the sep for sterile syringes.108 these numbers are staggering and illustrate how crucial harm reduction strategies can be for reducing the spread of infectious disease associated with intravenous drug use. moreover, another study conducted in scott county revealed that the utilization of an sep resulted in “an 88% reduction in syringe sharing, a 79% reduction in syringe sharing to divide drugs and an 81% reduction in sharing of other injection equipment.”109 the study also concluded that these findings are consistent with seps implemented in non-outbreak settings, thus concluding that the results of creating an sep in scott county are not outliers in the data but are consistent with seps created in other areas.110 iii. the role of laws: zoning in order to understand how zoning law can impact harm reduction initiatives and public health, it is important to first understand the basics of zoning law. a. village of euclid v. ambler realty co. the supreme court of the united states first declared zoning to be a constitutional practice with their decision in village of euclid v. ambler realty co.111 decided in 1926, justice sutherland, writing for the majority, declared that zoning is a constitutional use of the state’s police powers, in order to ensure the public welfare for its citizens.112 specifically, the court held that a zoning ordinance could not be held unconstitutional unless “such provisions are clearly arbitrary, and unreasonable, having no substantial relation to the public health, safety, morals, or general welfare.”113 additionally, the court stated that different zoning ordinances may be 105. id. 106. id. 107. id. 108. id. 109. jenna payesko, syringe services program implemented during hiv outbreak led to reduction of injection-related risk behaviors, hcp live (june 29, 2018), https://www.hcplive. com/view/syringe-services-program-implemented-during-hiv-outbreak-led-to-reduction-ofinjection-related-risk-behaviors [https://perma.cc/f3mk-x625]. 110. id. 111. see village of euclid v. amber realty co., 272 u.s. 365 (1926). 112. id. at 387. 113. id. at 395. 494 indiana health law review [vol. 19:481 appropriate under a certain set of facts or circumstances, while inappropriate in another scenario.114 justice sutherland further expounded that although a certain zoning ordinance may be appropriate in an urban environment, the same law may not be adequate in a rural community.115 moreover, the court reasoned that whether a certain property is a nuisance or detriment to that community must be determined by considering it in connection with the whole community.116 as the court’s opinion further stated, “a nuisance may be merely a right thing in the wrong place…[i]f the validity of the legislative classification for zoning purposes be fairly debatable, the legislative judgement must be allowed to control.”117 the court’s decision in euclid created the beginnings of nimbyism within the united states. for the first time, the supreme court declared that it was acceptable for a municipality to reject a community project or initiative simply because some members of the community may not like it. although the intentions of the court may have seemed benevolent, the decision nonetheless created malevolence within communities. not only would nimbyism be constitutionally permissible under this opinion, but racism too would find a strong foothold in zoning.118 b. olmstead v. l.c. the supreme court later ruled on housing discrimination in the landmark decision of olmstead v. l.c. decided at the turn of the century, the majority opinion written by the late justice ginsburg held that under the americans with disabilities act, individuals with mental disabilities have the right to live in a community instead of institutions.119 specifically, the court held that such action is proper “when the state’s treatment professionals have determined that community placement is appropriate, the transfer from institutional care to a less restrictive setting is not opposed by the affected individual, and the placement can be reasonably accommodated.”120 the court in olmstead analyzed the language passed by congress authorizing the attorney general to combat discrimination against the disabled under the ada.121 this authorizing language concluded that “unjustified placement or retention of person in institutions, severely limiting their exposure to the outside community constitutes a form of discrimination based on disability 114. id. at 387. 115. id. 116. id. at 388. 117. id. (citing radice v. new york, 264 u.s. 292, 294 (1924)). 118. see christopher silver, the racial origins of zoning in american cities, am. plan. ass’n (1997), https://www.planning.org/knowledgebase/resource/9190263/ [https://perma.cc/h637fc5a]. 119. olmstead v. l.c. ex rel. zimring, 527 u.s. 581, 587 (1999). 120. id. (citing 28 c.f.r. § 35.130 (1998)). 121. id. at 592. 2022] the intersection of harm reduction and zoning law 495 prohibited by title ii.”122 justice ginsburg reasoned that unjustified isolation reflects two judgements. first, it reflects that institutional placement of “individuals who can handle and benefit from community settings perpetuates unwarranted assumptions that person so isolated are incapable or unworthy of participating in community life.”123 second, justice ginsburg reasoned that “confinement in an institution severely diminished the everyday life activities of individuals, including family relations, social contacts, work options, economic independence, educational advancement, and cultural enrichment.”124 although the olmstead case was applied specifically to discrimination of disabled individuals under the americans with disabilities act, the antinimbyism sentiment permeates throughout the opinion. justice ginsburg reasoned that without the ability to live within a community and become a member of the community, the disabled individuals would face discrimination simply for existing.125 as stated in the opinion, the unjustified isolation would create a stigma around disabled individuals that could create even more discrimination against them.126 moreover, the court reasoned that without the ability to become a member of the community, disabled individuals would be discriminated not just through their unjustified isolation, but also through their ability to carry on familial relations, economic opportunities, educational advancement, and overall cultural enrichment.127 c. spot zoning though the supreme court declared zoning in general to be a constitutional practice in 1926, there are still many issues that arise in modern zoning law. instead, spot zoning, an unethical and technically illegal practice, has for many years operated behind the scenes in modern zoning law. spot zoning is primarily used to help facilitate specific land deals a zoning board prefers or bring an end to specific deals that a zoning board does not favor.128 in spot zoning, existing zoning rules are changed for the particular property. as a relevant example, a zoning board may impose a more stringent review process that specifically targets syringe exchange programs or safe consumption sites.129 122. id. at 596 (citing 28 c.f.r. § 35.130 (1998)). 123. id. at 600. 124. id. at 601. 125. see id. at 600. 126. id. 127. id. at 601. 128. jake blumgart, philly councilman mark squilla moves to block supervised injection site, whyy (mar. 29, 2019), https://whyy.org/articles/councilman-mark-squilla-moves-to-blocksupervised-injection-site-2/ [https://perma.cc/e79h-pyhr]. 129. see jared brey, why spot zoning is probably here to stay, whyy (nov. 14, 2014), https://whyy.org/articles/why-spot-zoning-is-probably-here-to-stay/ [https://perma.cc/9gbuyb92]. 496 indiana health law review [vol. 19:481 in indiana, spot zoning has been defined by the indiana court of appeals as “the singling out of one piece of property for a different treatment from that accorded to similar surrounding land which is indistinguishable from it in character, all for the economic benefit of the owner of the lot or area so singled out.”130 although there is no specific statute outlawing spot zoning within indiana, any action arising from it must meet the standard of a rational relation to the public health, safety, morals, convenience, or general welfare.131 it is clear from the indiana courts’ spot zoning test that the constitutionality of a zoning law or ordinance within indiana is essentially the same test implemented from the supreme court’s decision in euclid.132 d. indiana zoning law indiana zoning law is primarily concentrated at the local government level, with most of the power residing with planning commissions and boards of zoning appeals.133 additionally, the legislative body with jurisdiction over a geographical area has “exclusive authority to adopt a zoning ordinance.”134 when the legislative body adopts a zoning ordinance, it shall be for the purposes of “promoting the public health, safety, comfort, morals, and general welfare” as required by euclid.135 indiana zoning law lays out the specific procedure for new zoning ordinances. the planning commission must initiate the proposal and ensure that it complies with indiana law.136 next, the planning commission must give notice and hold a public hearing on the ordinance.137 the public hearing gives the general public and those who will be affected by the ordinance a chance to voice their opinion on the matter and state whether they believe the commission should approve or deny the ordinance, accordingly.138 the planning commission certifies the ordinance to the legislative body for their adoption, denial, or amendment of the proposed ordinance.139 if adopted, the ordinance will take effect; if rejected or amended, the ordinance will return to the planning commission for further consideration.140 the decisions of the legislative body and the planning commission are subject to review by a board of zoning appeals.141 the board of 130. scalambrino v. town of michigan shores, 904 n.e.2d 673, 682 (ind. ct. app. 2009) (quoting l & w outdoor adver. co. v. state, 593 n.e.2d 497, 499 (ind. ct. app. 1989)). 131. id. (citing hundt v. costello, 480 n.e.2d 284, 285 (ind. ct. app. 1985)). 132. village of euclid v. amber realty co., 272 u.s. 365, 395 (1926). 133. see ind. code § 36-7-4-602(a) (2016); see also ind. code 36-7-4-918.1 (2021). 134. ind. code § 36-7-4-601(a) (2021). 135. compare ind. code § 36-7-4-601(c)(3) (2021), with village of euclid, 272 u.s. at 395. 136. ind. code § 36-7-4-602(a) (2016). 137. id. 138. see id. 139. ind. code § 36-7-4-606(b)(1) (2021). 140. compare ind. code § 36-7-4-602(a) (2016), with ind. code § 36-7-4-606(g) (2021). 141. ind. code § 36-7-4-918.1 (2021). 2022] the intersection of harm reduction and zoning law 497 zoning appeals has authority to hear, review, and determine appeals under appealed zoning ordinances.142 the board of review’s decisions are often determinative of whether a given ordinance will survive without a serious challenge in court. e. the effects of nimby zoning in philadelphia the largest effect of the power of zoning law and nimbyism is best demonstrated in the city of philadelphia’s debacle over safehouse. following the decision of the district court in safehouse, safehouse went ahead with its plans to open the first safe consumption site in a residential area of southern philadelphia.143 after unveiling these plans, the philadelphia city council announced new restrictions on safe consumption sites, requiring them to get approval from 80% of residents and business within a one-mile radius.144 ironically, the philadelphia city council also threatened to reclassify the safe consumption site as a “nuisance health establishment.”145 “nuisance health establishments” is a property classification that was created by the city in response to the opioid crisis to denote unsafe medical facilities that would prescribe opioids too freely.146 the threats by the philadelphia city council can be plainly seen as nimbyism run amuck, afraid of the changing status quo within their own city and defending their actions with baseless stigmas. the fight over safehouse’s existence found its way to the state capitol, as members of the pennsylvania state legislature had taken notice of this ongoing battle. two companion bills were introduced that would apply specifically to safe consumption sites and require three public hearings plus authorization “via ordinance or resolution by the municipality in which the site is located.”147 this legislation specifically targeting safe consumption sites would be unconstitutional under the standard set forth in euclid, as these standards are arbitrary and unreasonable by forcing additional standards on only one type of organization.148 furthermore, the practices threatened by the philadelphia city council and embraced by the pennsylvania legislature would lead to spot zoning.149 the 142. id. 143. berr, supra note 10. 144. id. 145. nina feldman, bill to prevent supervised injection sites from opening in philly advances, whyy (mar. 9, 2020), https://whyy.org/articles/bill-to-prevent-supervised-injectionsites-from-opening-in-philly-advances/ [https://perma.cc/e3ms-la5l]. 146. id. 147. john l. micek, philly dem’s bill would give local residents a say over safe injection sites, pa. cap. star (mar. 4, 2020, 7:06 am), https://www.penncapital-star.com/commentary/ philly-dems-bill-would-give-local-residents-a-say-over-safe-injection-sites-wednesday-morningcoffee/ [https://perma.cc/eds8-nm8t]. 148. village of euclid v. amber realty co., 272 u.s. 365, 395 (1926). 149. blumgart, supra note 128. 498 indiana health law review [vol. 19:481 proposed actions would specifically target safehouse and make the process of establishing safe consumption sites, now and in the future, more difficult.150 developments following the efforts by the philadelphia city council and the pennsylvania legislature ultimately led the district court to issue a stay on its ruling in united states v. safehouse.151 in june 2020, the court cited national protests and the coronavirus pandemic as reasons to delay changing the status quo in philadelphia so drastically.152 in addition, safehouse decided to move the location of its proposed safe consumption site facility from south philadelphia to the neighborhood of kensington, an area considered to be the epicenter of the opioid epidemic in the city.153 as illustrated through the fight against nimbyism in philadelphia, public health initiatives can face tremendous challenges. even if harm reduction is legalized under state and federal law, these facilities most often face the additional challenge of convincing local residents that they are part of the solution, not an additional problem in the community. for example, even though safehouse won their battle in district court, it has faced challenge after challenge from local nimbys. iv. a case study in zoning: harm reduction in indiana a. nimbyism in indiana: nothing new the power of nimbyism and its effect on zoning is not new in indiana. in fact, it has recently been evident in debates over wind farms. in 2016, many small towns in rural indiana became disgruntled over proposed construction of wind farms.154 residents of rush county, indiana claimed their views of the farmland would be permanently tarnished and that home values would plummet as a result of the construction of sixty-five wind turbines.155 a group of residents even convinced county commissioners to back out of an agreement, which had been in place for over a decade already, allowing for the creation of these wind farms.156 following the pressure of residents, a complaint was filed in state court by 150. see micek, supra note 147; see also berr, supra note 10. 151. jeremy roebuck, facing pandemic and protests, philly too ‘frayed’ for a supervised injection site right now, judge rules, phila. inquirer (june 24, 2020), https://www.inquirer.com/ health/opioid-addiction/safe-injection-site-legal-philly-safehouse-mcswain-mchugh-appeal-thirdcircuit-20200624.html [https://perma.cc/e28l-q5mm]. 152. id. 153. winberg, supra note 63. 154. maureen hayden, wind farms whipping up opposition across rural indiana, glasgow daily times (june 8, 2016), https://www.glasgowdailytimes.com/wind-farms-whippingup-opposition-across-rural-indiana/article_2a9d244d-0737-5308-96e6-5a255af08e7e.html [https://perma.cc/483w-qgkk]. 155. id. 156. id. 2022] the intersection of harm reduction and zoning law 499 residents, with the court upholding local zoning ordinances that would prohibit the proposed turbines from being within a half-mile of the neighboring property.157 a similar complaint was filed by residents in fayette county, indiana against county commissioners and the developer of the wind farm.158 a number of other counties, some of which already had wind farms, placed moratoriums on any future agreements with developers as a result of the upswell of nimbyism and resulting zoning conflict.159 however, just as with harm reduction organizations, as unpopular as these sites may be with local residents, the benefits often remain overlooked by nimbys. typically, property owners can make an average of $5,000 a year per turbine from wind farm leases.160 these revenues can then be used to support the local economy through increased consumer spending. additionally, the revenues can also be used to generate money for schools in rural counties through property taxes.161 often overlooked, the benefits of these wind farms outweigh the potential loss in property values or aesthetics. in a similar vein, activist group solar crisis has been fighting against the creation of an 850-acre solar panel farm in madison county, indiana.162 the project had already been approved by the board of zoning appeals, and an injection of $110 million into the local economy of madison county was expected.163 although the project had already been approved by local leaders, residents of the county filed two lawsuits in order to delay the project.164 just as with the example of nimbyism surrounding wind farms within indiana, the solar farm would provide the county with clean, renewable energy, as well as an injection of funds into the local economy. the lawsuits concerning the madison county solar panels remain pending. if nimbyism was left unfettered, there is no telling what beneficial projects would be turned down next. b. what to expect for the future of harm reduction in indiana indiana has yet to experience a wave of nimbyism as tumultuous as the battle over philadelphia’s safehouse site, but there is certainly apprehension about harm reduction sites within the state. as was seen following the hiv outbreak in scott county in 2015, people were concerned about the approval of 157. id. 158. id. 159. id. 160. id. 161. id. 162. kelsey brugger, meet the 'nimby people' trying to kill solar, politicopro (oct. 3, 2019, 7:11 am), https://www.eenews.net/stories/1061185363 [https://perma.cc/qv4e-w6h9]. 163. id. 164. john p. cleary, no. 2: local residents voice opposition to projects, herald bull. (dec. 31, 2019), https://www.heraldbulletin.com/news/no-local-residents-voice-opposition-toprojects/article_e5a6d548-2b11-11ea-aa49-db844a24b0ad.html [https://perma.cc/5qcv-26df]. 500 indiana health law review [vol. 19:481 syringe exchange programs.165 even then-governor mike pence said he personally opposed such programs, but he allowed for the creation of provisional needle exchanges for the time being.166 pence claimed that needle exchange programs would lead to further drug use and disease in communities, contrary to evidence that these programs would help curb spread of disease and substance use disorder within the community.167 some residents diagnosed with hiv refused to receive antiretroviral treatment out of fear of being ostracized by members of the community, and the notion that hiv was a “homosexual disease” was prevalent in scott county.168 these negative stereotypes, outright refusal of medical treatment, and personal opposition to syringe exchange programs have only compounded the challenge of reducing the harm of intravenous drug use within indiana. only nine of the ninety-two counties within the state of indiana currently operate syringe exchange programs.169 madison county, in central indiana, has also had difficulty with the viability of its syringe exchange program .170 in 2015, madison county became the second county in indiana to create a syringe exchange program, after scott county, the site of the original hiv outbreak.171 however, in august 2017, following the passage of indiana public law 1982017, five of the seven council members for madison county voted to end the program.172 when asked why they voted to end the program, council members stated that constituents were worried about attracting drug users from surrounding counties and syringes being disposed of in public places.173 the program was then placed in limbo after the council failed to take action.174 the program continues to provide services for hepatitis c testing plus community outreach and education, but the program must refer individuals to other facilities for needle disposal services.175 while it is often claimed that these programs will adversely affect their communities, syringe exchange programs have been substantially successful in reducing the harms of drug use in indiana. as stated previously, from the year 165. conrad, supra note 81. 166. id. 167. id. 168. id. 169. bruce, supra note 1. 170. officials halt central indiana county's needle exchange, wfyi (june 22, 2020), https://www.wfyi.org/news/articles/officials-halt-central-indiana-countys-needle-exchange [https://perma.cc/ud2m-wqlb]. 171. sarah fentem, residents' fears drive first closure of an indiana needle exchange, wfyi (aug. 10, 2017), https://www.wfyi.org/news/articles/residents-fears-drive-first-closure-ofan-indiana-needle-exchange [https://perma.cc/9ath-4t83]. 172. id. 173. id. 174. officials halt central indiana county's needle exchange, supra note 170. 175. id. 2022] the intersection of harm reduction and zoning law 501 2016 to 2017, drug overdose deaths in indiana rose by 22.5%.176 in the following period from 2017 to 2018, drug overdose deaths dropped by 12.9%.177 moreover, new studies have found that if a response to the hiv outbreak in scott county had been initiated earlier, the number of hiv infections could have been drastically reduced.178 recently, madison county commissioners have requested the county attorney draft a resolution to reinstate and extend the sep.179 support for the reinstatement of the program came from local county officials, the indiana state department of health, and governor eric holcomb.180 in addition to reestablishing the sep within madison county, the indiana general assembly extended the authorization for seps in indiana through 2026 with public law 130-2021.181 thus, the spirit of harm reduction and compassion for those suffering from substance use disorder is still alive and well within the hoosier state. v. analysis: overcoming zoning to support harm reduction a. zoning boards should be preempted from using arbitrary community standards for harm reduction sites under indiana law, there is no requirement that a property owner or organization must seek an arbitrary amount of approval from residents in order to have a zoning ordinance approved.182 the necessity of such a requirement would run contrary to the united states supreme court’s ruling in euclid as well as indiana law.183 in order to avoid the zoning and public relations fiasco seen in philadelphia, indiana should preempt local zoning regulations seeking to adopt arbitrary community approval standards for harm reduction sites. the adoption of arbitrary standards for harm reduction sites would be in derogation of the supreme court’s ruling in euclid that a zoning ordinance cannot be held unconstitutional unless “such provisions are clearly arbitrary and unreasonable, having no substantial relation to the public health, safety, morals, 176. 2016-2017 drug overdose death rate increases, supra note 95. 177. id. 178. michael greenwood, new study finds hiv outbreak in indiana could have been prevented, yale news (sept. 13, 2018), https://news.yale.edu/2018/09/13/new-study-finds-hivoutbreak-indiana-could-have-been-prevented [https://perma.cc/463x-we38]. 179. ken de la bastide, commissioners to consider extending needle exchange program, herald bull. (jan. 19, 2021), https://www.heraldbulletin.com/news/local_news/commissionersto-consider-extending-needle-exchange-program/article_15448690-5a75-11eb-ae62df8b1bc1d659.html [https://perma.cc/wuj6-8ejv]. 180. id. 181. id.; see also pub. l. 130-2021, 122nd gen. assemb., reg. sess. (ind. 2021). 182. see ind. code § 36-7-4-606 (2020). 183. compare ind. code § 36-7-4-601(c)(3) (2020), with village of euclid v. amber realty co., 272 u.s. 365, 395 (1926). 502 indiana health law review [vol. 19:481 or general welfare.”184 forcing a harm reduction program to seek approval from 80% of residents or businesses in a one-mile radius, as was done with safehouse, is arbitrary and arguably unreasonable, doing more to harm public health than to help it.185 does the approval of residents outside of the one-mile radius not matter? why must 80% of residents and businesses approve? a resident may not approve of a pharmacy with a drive-through being built within their community, but the pharmacy would not be required to seek approval from the residents before beginning operations on their property. moreover, specifically targeting harm reduction sites is, simply put, spot zoning by a community. it would be entirely unreasonable to create a set of rules for one specific variation of a medical facility, when all other medical facilities are not required to follow the same process or guidelines. additionally, although local zoning authorities consider the effect on a community and real estate prices when making decisions, research suggests that the presence of harm reduction sites does not lead to a rise in crime or hamper real estate prices.186 for example, in vancouver’s downtown eastside neighborhood, at the site of canada’s first safe consumption site, property values have skyrocketed in recent years.187 in fact, real estate prices in this vancouver neighborhood have continued to rise despite the fact that eight safe consumption sites now operate within a two-mile radius.188 on the other hand, there will be particular difficulty producing this type of legislation as indiana has been a “home rule” state since 1980.189 under the 1980 home rule act, “the policy of the state is to grant counties, municipalities, and townships all the powers that they need for the effective operation of government as to local affairs.”190 modeled on the principle of federalism, home rule allows a state to delegate more flexibility and freedom to a municipalities and govern themselves as they see fit.191 however the indiana general assembly has enacted numerous laws that walk back on the home rule. for example, legislation was proposed that would have preempted local rules surrounding airbnb and banning of local regulation of antennas and utility poles.192 additionally, the home rule act has also been used to prevent locally established minimum wage rates from 184. village of euclid, 272 u.s. at 395. 185. berr, supra note 10. 186. see id. 187. id. 188. id. 189. joshua claybourn, claybourn: in defense of hoosier home rule, indystar. (may 7, 2017, 5:04 am), https://www.indystar.com/story/opinion/2017/05/07/claybourn-defense-hoosierhome-rule/101289696/ [https://perma.cc/8bxs-pdw4]. 190. ind. code § 36-1-3-3 (2021); see also tippecanoe county v. indiana manufacturer’s association, 784 n.e.2d 463, 466 (ind. 2003). 191. claybourn, supra note 189. 192. ind. code § 36-1-3-3; see also id. 2022] the intersection of harm reduction and zoning law 503 exceeding the minimum wage set by the state government.193 if the home rule act has been limited in the past, it seems reasonable to assume that the indiana legislature could preempt local zoning boards from discriminating against harm reduction facilities in a similar way. if the indiana state government can preempt municipalities from increasing the local minimum wage, why not do the same to bolster public health initiatives?194 the indiana general assembly should pass legislation protecting harm reduction sites from being targeted by nimbys within a community. moreover, the importance of protecting individuals from the effects of substance use disorder and furthering public health initiatives seem to warrant the preemption of a locality’s discrimination of harm reduction facilities. unlike regulating local control of antennas or utility poles, preempting local zoning law in the furtherance of public health is particularly important within indiana. although the state has made considerable progress in the implementation of harm reduction strategies so far, it is clear that nimbyism will not simply just roll over and die. as can be seen in the case study of harm reduction sites struggling to find a foothold in indiana communities, as well as the struggle for safehouse to find a site of operation within philadelphia, nimbyism permeates throughout communities.195 when individuals are simply seeking compassion and medical care, it seems superfluous to dismiss them just because some members of the community may not like the form in which they receive care. b. when the mission of a property is in the furtherance of public health and general welfare, zoning ordinances should not be denied it is the mission of a harm reduction site to further public health and provide non-judgmental and compassionate access to treatment for people who use drugs.196 these sites are sometimes the only access an individual has to the resources that can help them recover and mitigate the effects that using drugs has on their lives.197 nimbys rely on a false narrative when they claim that the creation of these sites and programs will lead to a deterioration in public health through increased drug use in a community. contrary to what is often claimed, the presence of harm reduction sites and programs within a community often lead to better public health outcomes. as stated previously, from the year 2016 to 2017, drug overdose deaths in 193. jon davis, from minimum wage to “soda tax,” local policies preempted by states, council st. gov’t (nov. 28, 2017, 8:41 am), https://knowledgecenter.csg.org/kc/content/ minimum-wage-soda-tax-local-policies-preempted-states [https://perma.cc/682w-97sv]. 194. id. 195. see officials halt central indiana county's needle exchange, supra note 170; see also fentem, supra note 171; compare with berr, supra note 10. 196. principles of harm reduction, supra note 31. 197. see bruce, supra note 1. 504 indiana health law review [vol. 19:481 indiana rose by 22.5%.198 in the following period from 2017 to 2018, drug overdose deaths dropped by 12.9%.199 it is more likely than not, that the access to syringe exchange programs in indiana led, at least in part, to the sharp decrease in overdose deaths recorded by the center for disease control. this is supported by results from other safe consumption sites. for example, insite, the first safe consumption site in canada, was found to have averted approximately fifty deaths within its first three to four years of operation.200 these deaths were found to have been prevented because people were less likely to engage in harmful behaviors associated with drug use.201 it was also discovered that although individuals would use drugs under medical supervision at insite, there were no signs that it led to an increase or further encouragement of drug use within the area.202 it therefore would again be in derogation of the supreme court’s reasoning in euclid to deny zoning ordinances for harm reduction sites based on public health concerns. it is the express mission of a harm reduction site to further public health and provide non-judgmental and compassionate access to treatment for people who use drugs.203 as eloquently stated in united states v. safehouse, “[a]n action taken ‘for the purpose of’ unlawful drug use would therefore refer to a purpose of facilitating drug use, not an effort to reduce drug use.”204 furthermore, it is clear from research that harm reduction sites or programs do not lead to increased drug use within an area, but actually lead to better public health outcomes overall.205 moreover, the reasoning of justice ginsburg in olmstead could also be applied to individuals suffering from substance use disorder. individuals with substance use disorder have a right to seek care within the community they live in, just as mentally disabled individuals have a right not to be unjustifiably institutionalized.206 additionally, by allowing individuals battling substance use disorder to seek care through syringe exchange programs and safe consumption sites within their community, it would avoid the “unwarranted assumptions” about these individuals that justice ginsburg warned could lead to further discrimination of mentally disabled individuals in the olmstead opinion.207 if members of a community could see that individuals battling substance use disorder are looking for proper medical care and compassion, it may help to alleviate the stigma that follows harm reduction sites and organizations. finally, the opinion by justice ginsburg in olmstead also indicates a level of 198. 2016-2017 drug overdose death rate increases, supra note 95. 199. id. 200. gordon, supra note 8. 201. id. 202. id. 203. principles of harm reduction, supra note 31. 204. united states v. safehouse, 408 f. supp. 3d 583, 609 (e.d. pa. 2019). 205. see 2016-2017 drug overdose death rate increases, supra note 95; see also gordon, supra note 8. 206. see olmstead v. l.c. ex rel. zimring, 527 u.s. 581 (1999). 207. see id. 2022] the intersection of harm reduction and zoning law 505 support for public health officials that too often seems to be missing in the debate surrounding harm reduction sites. in olmstead, the court held that individuals that are mentally disabled have a right to live in the community if “the state’s treatment professionals have determined that community placement is appropriate.”208 similarly, one can clearly see how the same logic would apply to harm reduction sites. an astounding amount of research has exhibited the effectiveness of harm reduction sites in fighting substance use disorder. when so many public health officials are advocating for harm reduction sites to operate without impediment within a community, perhaps it’s time to allow public health officials to use harm reduction solutions that research has shown prove effective in battling substance use. vi. conclusion the fight for harm reduction sites is far from over. there is no doubt that as new sites are proposed, nimbyism will continue to obstruct these public health initiatives. as evidenced by the safehouse fight in philadelphia, winning a federal court case does not mean much if local pushback and nimbyism prevent individuals with substance and opioid use disorder from getting the help that they so desperately need. in order to ensure that public health does not take a back seat to the whims of nimbys in a community, the indiana legislature must act to ensure that syringe exchange programs and even safe consumption sites are allowed and protected. specifically, arbitrary and unreasonable zoning practices must be challenged. furthermore, legislation must be passed outlawing spot zoning within indiana. although some individuals may claim it is beyond the purview of the general assembly to pass legislation in such a manner, the preemption of the indiana home rule act in the past upholds the general assembly’s power to do so.209 moreover, it is the mission of a harm reduction site to further public health and provide non-judgmental and compassionate access to treatment for people who use drugs.210 it would be in derogation of the supreme court’s reasoning in euclid to claim the denial of zoning ordinances for harm reduction sites based on public health concerns. it is the express mission of a harm reduction site to further public health and provide non-judgmental and compassionate access to treatment for people who use drugs.211 finally, the denial of zoning and property rights to harm reduction sites could lead to the exact “unwarranted assumptions” warned against by justice ginsburg in the olmstead opinion.212 finally, it is imperative for local citizens and organizations to stand up 208. id. at 587. 209. see claybourn, supra note 189; see also davis, supra note 193. 210. principles of harm reduction, supra note 31. 211. see id. 212. see generally olmstead, 527 u.s. at 581. 506 indiana health law review [vol. 19:481 against unfair and prejudicial practices when public health initiatives are threatened. as stated previously, harm reduction sites are often some of the only places within a community that a person struggling with substance use disorder issues can receive non-judgmental and compassionate care.213 without access to these resources, more hoosiers will continue to go without care and without the resources that will continue to support them on the road to recovery. it is the responsibility of individuals within these communities to act as stewards for those that have been dismissed or overlooked by society. members of a community must have compassion for one another. every member of a community is entitled to the same level of compassion no matter their experience with substance use disorder. 213. see bruce, supra note 1. ihlr vol 14 iss. 2.pdf http://doi.org/10.18060/3911.0036 #nofilter: a critical look at physicians sharing patient information on social media elissa tucci* i. introduction a. the issue: social media is ripe for hipaa breaches despite long-standing privacy rules set out in the health insurance portability and accountability act (“hipaa”), blatant violations have made headlines as recently as september 2017 when disturbing images posted to snapchat by nurses at a naval hospital went viral.1 one image depicted a nurse flipping her middle finger at an infant with the caption, “[h]ow i currently feel about these mini satans.”2 another post was a video of a nurse mishandling a newborn by making it appear to dance as music played in the background.3 such violations are clearly problematic for numerous reasons, including the erosion of patient trust.4 a cornerstone of the patient-physician relationship is that the patient can reasonably rely upon the physician to maintain confidentiality of private health information, including information divulged by the patient “about [his or her] health, symptoms, and medical history.”5 it is imperative that physicians maintain confidentiality in order to receive complete and accurate information about the patient, because “[i]n the absence of full and accurate information, there is a serious risk that the treatment plan will be inappropriate to the patient’s situation.”6 patients need to have trust in their physicians that their private health information will not be inappropriately disclosed, which, in turn, ensures patients continue to freely provide that information. as the use of social media becomes more integrated in society, physicians have begun to incorporate its use in daily practice.7 professional use of social * j.d. candidate, 2019, indiana university robert h. mckinney school of law; b.a. history and political science 2012, saint mary’s college. 1. kristine philips, disturbing images show navy hospital staffers mishandling infant, calling babies ‘mini satans’, wash. post (sept. 19, 2017), https://www.washingtonpost. com/news/checkpoint/wp/2017/09/19/disturbing-images-show-hospital-staffers-mishandling-aninfant-calling-babies-mini-satans/?utm_term=.77506ecc1ba5 [https://perma.cc/aq76-hes4]. 2. id. 3. id. 4. charles ornstein, small violations of medical privacy can hurt patients and erode trust, nat’l pub. radio (dec. 10, 2015, 4:59 am), https://www.npr.org/sections/healthshots/2015/12/10/459091273/small-violations-of-medical-privacy-can-hurt-patients-and-corrodetrust [https://perma.cc/dmx8-he6b]. 5. see standards for privacy of individually identifiable health information, 65 fed. reg. 82,462-01, 82,467 (dec. 28, 2000) (to be codified at 45 c.f.r. pts. 160 & 164). 6. id. 7. taylor bryant, why we can’t get enough of snapchat surgeries, refinery29 (june 6, 2016, 6:00 pm), http://www.refinery29.com/2016/06/112898/snapchat-surgeons 326 indiana health law review [vol. 16:325 media has been lauded as an “effective method to connect with colleagues, advance professional expertise, educate patients, and enhance the public profile and reputation of [the] profession.”8 however, the concern remains that information posted by physicians to social media must comply with legal standards and meets general standards for ethics and professionalism within the medical community.9 despite clear laws regarding how to obtain authorization for disclosure of patient health information, any guidance relating to how to professionally or ethically disclose that information on social media is vague at best. part of the reason behind the ambiguity is because applicable regulations set forth by the department of health and human services (“hhs”) are not intended to provide definitive measures for implementing safeguards.10 the lack of clear guidelines to assist physicians in crafting social media posts has led to mixed results in the level of professionalism or ethics in posted content. although this is a concern for all social media platforms, it is particularly problematic in regards to snapchat, where a number of physicians have been able to amass large followings due to the clinical content they post.11 snapchat has relatively lax community standards for posted content, enabling physicians to post raw, graphic glimpses into their days in almost real time.12 this form of posting in real time can have serious consequences because content posted on snapchat rarely undergoes the same rigor of review given to posts on other media platforms. snapchat’s lax community guidelines concerning content, coupled with current ethical standards that need updating and clearer definitions, creates a breeding ground ripe for privacy violations. ameliorating the problems associated with physicians’ use of social media will require implementing a professional responsibility test, creating clear guidelines, or even imposing a heightened duty on physicians who post to social media. b. roadmap section ii of this note will examine the growing role social media plays in the practice of modern medicine. although they developed from humble origins, the giants of social media now play a tremendous role in shaping the way people [https://perma.cc/38um-pvks]. 8. kerry ann hayon et al., mass. med. soc’y, a guide to social media for the physician practice 12 (2014). 9. katherine c. chretien & terry kind, social media and clinical care: ethical professional, and social implications, 127 circulation 1413, 1413-21 (2013). 10. standards for privacy of individually identifiable health information, 65 fed. reg. 82,462-01, 82,562 (2000) (to be codified at 45 c.f.r. pts. 10 & 164) (“we do not prescribe the particular measures that covered entities must take to meet this standard, because the nature of the required policies and procedures will vary with the size of the covered entity and the type of activities that the covered entity undertakes.”). 11. bryant, supra note 7. 12. community guidelines, snapchat, https://support.snapchat.com/en-gb/a/guidelines [https://perma.cc/m9zs-ggpw]. 2019] #nofilter 327 interact through online communications. snapchat first launched after the more well-known platforms, like facebook and instagram, had already solidified their influence. however, snapchat’s innovative features and transitory nature carved an unmistakable niche into the landscape of social media. in recent years, physicians have begun to incorporate snapchat into their daily office routines, including regularly posting consultations and follow-ups with actual patients. this move has reaped tangible benefits for these physicians in the form of improved patient trust and increased booking rates for procedures. yet, due to the nature of the content, these types of posts have been met with skepticism from other physicians and media alike. section iii will lay out some of the important regulations that preserve patient privacy and check the free distribution of information across social media platforms. this section of the note will examine hipaa’s privacy rule, which sought to protect patient information in the increasingly digital age, and reveal what providers need to do in order to post patient information on social media. this section will also examine guidelines that medical administrative bodies, such as hhs, the american medical association (“ama”), and the federation of state medical boards (“fsmb”), have issued in an attempt to establish standards for proper behavior on social media. section iv takes a hard look at whether the current climate for social media use in the practice of medicine is overor under-regulated. federal and state laws are surprisingly sparse when it comes to this cutting-edge dilemma. of the existing cases and laws that address this issue, most give deliberately vague guidance. major medical groups tend to defer to these laws, leaving doctors with more questions than answers. in an effort to avoid the severe penalties associated with hipaa violations, many major medical groups have enacted blanket bans on physicians posting to social media. as a result, most of the physician snapchat accounts used in the clinical setting belong to independent physicians or to physicians who are part of small group practices. such accounts tend not to have nearly as much of the administrative policing that is found in larger health care organizations. this note will then explore how this lack of oversight has led to mixed results regarding the value or ethicalness of posted content and provide examples demonstrative of this range. section v of this note will provide some potential suggestions to improve the situation that will preserve the free spirit of snapchat while curtailing breaches of patient information or unethical behavior. first, the medical field could implement a mandatory medical ethics exam as part of the physician licensing requirements. this examination could mirror the multistate professional responsibility examination (“mpre”) that lawyers have to pass. just as the mpre is based upon the american bar association’s (“aba”) model rules of professional conduct, the ama could expand on its code of medical ethics, which could then be tested by the fsmb. secondly, while existing laws or guidelines have provided a barebones framework for the issue, they lack clear, specific language to inform proper standards for physician social media behavior. an update providing this much needed clarity would be valuable to make informed choices before uploading any content. a third proposal explores whether the imposition of a heightened duty for physicians who post to social 328 indiana health law review [vol. 16:325 media would encourage more careful social media practices. finally, in section vi, this note will conclude with outlooks of the future for physicians using snapchat if these plans are fully executed. ii. social media a. social media’s rise to dominance social media’s role as a conduit of online communications emerged not long after computers were integrated in the work-place; the late 1970s saw the introduction of virtual newsletters and bulletin boards.13 by the mid-1990s, the creation of geocities became the first instance of social networking as we recognize it today.14 this first online community set off a wave of innovation in the late 1990s and beyond; “blogger (1999), wikipedia (2001), myspace (2003), facebook (2004), flickr (2004), youtube (2005), twitter (2006), and a wide array of ensuing platforms began to offer web tools that sparked old and new online communication tactics.”15 each new iteration of these platforms was influenced by previous ones and used as a stepping stone for creating new, innovative ways to communicate. since their emergence, “social media platforms have penetrated deeply into the mechanics of everyday life, affecting people's informal interactions, as well as institutional structures and professional routines.”16 by tapping into our underlying enjoyment of social interactions, this wave of platforms, based on user participation, content creation, and interaction, has quickly gained popularity.17 as of august 2017, the estimated number of monthly active users for twitter, instagram, and facebook were 328 million, 700 million, and 2.047 billion, respectively.18 b. snapchat changed the game although media giants facebook, twitter, and instagram already dominated the market, snapchat managed to quickly become a major competitor. since its inception in 2011, snapchat boasts one of the most unprecedented growth rates of any social networking platform—estimates report the number of active daily 13. erin k. wise & jack d. shorter, social networking and the exchange of information, 15 issues info. sys. 103, 103 (2014). 14. id. 15. josé van dijck, the culture of connectivity: a critical history of social media 7 (2013). 16. josé van dijck & thomas poell, understanding social media logic, 1 media & comm. 2, 3 (2013). 17. van dijck, supra note 15, at 10-14. 18. brett williams, there are now over 3 billion social media users in the world—about 40 percent of the global population, mashable (aug. 7, 2017), http://mashable.com/ 2017/08/07/3-billion-global-social-media-users/#tiwwfvqrkaq0 [https://perma.cc/h4lx-ly2y]. 2019] #nofilter 329 users grew from 10 million to 100 million between mid-2012 and early 2015.19 with 188 million daily active users and more than 10 billion mobile videos viewed per day as of october 2018, snapchat maintains a modest, yet strong presence in the online community.20 the platform’s defining feature is precisely what allowed it to flourish. while other social networks focus on creating features that allow users to get “#gramworthy” photos,21 snapchat takes a decidedly different approach by limiting any user-generated content to be ephemeral in nature.22 due to its roots as a mobile application, snapchat’s features center on instantly sharing photos or videos wherever its users may have their phones in hand.23 snapchat differentiates itself from other platforms by taking a contrasting approach to the temporal duration in which content may be viewed; whereas traditional social media like facebook operate “like a modern day time capsule,” snapchat retains relatively little content for users to later revisit, maintaining an “in-the-moment example of what’s going on.”24 content shared on snapchat may only be viewed temporarily, where the length of view time can range from as little as one to ten seconds for direct messages, all the way up to twenty-four hours for content posted to a snap story.25 a crucial element of snapchat’s functionality allows users to select an audience for postings. as opposed to direct snaps, which can only be viewed by intended recipients, snap stories compile the snaps posted by the user to their story that day and allow potentially anybody to view them an unlimited amount of times for a 24-hour period.26 like any other social networking platform, users 19. lukasz piwek & adam joinson, “what do they snapchat about?” patterns of use in time-limited instant messaging service, 54 computers hum. behav. 358, 358 (2015). 20. snapchat – statistics & facts, statista, https://www.statista.com/topics/2882/snapchat/ [https://perma.cc/w8qd-qbxk]. 21. see teigan stafford-bush, is it #gramworthy? an investigation of self-concept clarity, social media and body related issues and how this relates to teenage self presentation on instagram (2017) (unpublished m.s. thesis, massey university) (on file with massey university) (noting how features like filters and hashtags assisted with discovery of content and optimization of profiles). 22. brian hart, snapchat’s appeal is the ephemeral nature of its user-generated content, medium (oct. 23, 2016), https://medium.com/@bbhart/snapchats-appeal-is-the-ephemeral-natureof-its-user-generated-content-though-that-ephemerality-b6dfc0c09d6f [https://perma.cc/x8kktrbr]. 23. joseph b. bayer et al., sharing the small moments: ephemeral social interaction on snapchat, 19 info., comm. & soc’y 956, 959 (2015). 24. id. at 968. 25. andrew c. billings, et al., permanently desiring the temporary? snapchat, social media, and the shifting motivations of sports fans, 5 comm. & sport 10, 11 (2015); create a snap, snapchat, https://support.snapchat.com/en-us/a/capture-a-snap [https://perma.cc/aw68z5er]; my story, snapchat, https://support.snapchat.com/en-us/article/view-stories [https:// perma.cc/77mm-ylh7]. 26. my story, supra note 25. 330 indiana health law review [vol. 16:325 are given options regarding their privacy settings. for example, in regards to who can view posts, users not only have the option of allowing their posts to be viewed either publicly or only by their friends, but there is also an option for blocking selected individuals.27 through the use of stories, some snapchatters have amassed large followings by giving a glimpse into their daily lives.28 the subject matter or composition of content generated by users exemplifies another way in which snapchat noticeably diverges from traditional media sharing platforms. content generated by snapchat users reflects a carefree attitude, where a majority of the images shared focus on mundane or everyday occurrences.29 common themes include pets, food, weather, or sharing the viewpoint of the poster’s current location.30 many posts take the form of “selfies,” where users take a photograph of themselves, “often with an exaggerated expression related to the immediate context.”31 these posts are less concerned with exuding an artistic expression and, instead, embrace realism to its furthest extent. snapchat has a clear understanding of how its user base utilizes the platform, and the platform even goes so far as encouraging these deliberately bad32 images by providing “face lenses” and “world lenses” to superimpose over images.33 available lens options have included flower crowns, animal caricatures, and face swapping effects.34 this focus on extemporaneous, raw multimedia sharply contrasts with the polished works encountered on instagram, where users strive to carefully cultivate and curate content to achieve a desired aesthetic.35 snapchat’s privacy policy also distinguishes it from its peers. content is automatically deleted by snapchat’s servers.36 the photos and videos exchanged are not only deleted from what the user is able to access, but snapchat also 27. privacy settings, snapchat, https://support.snapchat.com/en-us/a/privacy-settings [https://perma.cc/zh55-8fs4]. 28. ravi r. patel et al., dermatology on snapchat, 23 dermatology online j. 1, 1 (2017). 29. bayer et al., supra note 23, at 967. 30. id. 31. id. 32. while the phenomenon of posting deliberately bad photographs is not unique to snapchat, it is certainly ubiquitous on this platform. it is not difficult to spot photos that fit this category. there are a myriad of reasons why a photo may deviate from conventional understandings of what constitutes a good image, including poor lighting, not having the subject in focus, white balance, or even making an ugly face. 33. face lenses & world lenses, snapchat, https://support.snapchat.com/en-us/a/faceworld-lenses [https://perma.cc/ww5l-j7gw]. 34. grace palmer, how to use filters on snapchat and the most popular ones, telegraph (june 30, 2017, 5:27 pm), http://www.telegraph.co.uk/technology/0/use-filters-snapchat-popularones [https://perma.cc/e384-pshx]. 35. anna guerrero, how to establish an instagram aesthetic: 10 brands doing it right, hu b sp o t , h t tps://blog.hubspot.com/marketing/establish-an-instagram-aesthetic [https://perma.cc/766r-hmet] (last updated oct. 31, 2017). 36. when does snapchat delete snaps and chats?, snapchat, https://support.snapchat.com/ en-us/a/when-are-snaps-chats-deleted [https://perma.cc/58xz-23ku]. 2019] #nofilter 331 deletes the content of those snaps from its servers.37 the timing of the deletion depends on the form of the post—direct messages are automatically deleted once they have been viewed by the recipient and stories are automatically deleted after twenty-four hours.38 because of this policy, snapchat advises its users that it is “unable to provide copies of snaps to snapchatters.”39 however, snapchat is careful to warn users that although content is automatically deleted from its servers, there is no guarantee that other users will not employ their own imagecapture software to store copies of snaps.40 in contrast, other platforms have features to help users produce account content. for example, while facebook will produce account content in certain contexts, including in response to “a valid subpoena issued in connection with an official criminal investigation,”41 users can produce an archived copy of their account’s content using facebook’s archival tool, which is accessible through the settings page.42 although snapchat remains relevant in its own right, other platforms like facebook and instagram have recognized the value of snapchat’s key features and have, in turn, created their own versions for use in their applications.43 a perfect example of this can be seen in the rollout of instagram’s stories; critics note it feels like a carbon copy of snapchat’s defining features, down to the “face filters, location tags, stickers, drawing tools, and disappearing photo messages.”44 as often happens in quickly growing markets, competition from instagram has eroded snapchat’s base of users to the point that instagram boasts more daily users than snapchat.45 furthermore, for some of the features common to both platforms, some users have indicated a preference for instagram’s version over snapchat’s.46 in recent quarters, snapchat’s growth rate has been sluggish, leading to speculation that snapchat is struggling to innovate as competition from 37. privacy policy, snapchat, https://www.snap.com/en-us/privacy/privacy-policy/ [https://perma.cc/c35z-2wsp] (last modified oct. 1, 2018). 38. when does snapchat delete snaps and chats?, supra note 36. 39. request a copy of a snap, snapchat, https://support.snapchat.com/en-gb/article/snapcontent [https://perma.cc/q2kn-qkd3]. 40. privacy policy, supra note 37. 41. information for law enforcement authorities, facebook, https://www.facebook.com/ safety/groups/law/guidelines/ [https://perma.cc/kx4y-apmp]. 42. how can i download my information from facebook?, facebook, https://www. facebook.com/help/212802592074644 [https://perma.cc/955h-swkq]. 43. sarah frier, instagram copies snapchat again, this time with fun face masks, bloomberg (may 16, 2017, 9:00 am), https://www.bloomberg.com/news/articles/2017-051 6 / in s t agram -copies -sn apch a t -aga in -th is -t ime-w ith -fu n -face -m asks -j2 rkfu u t [https://perma.cc/f28s-v8dz]. 44. avery hartmans, we compared snapchat and instagram to find out which app is better—here’s the winner, bus. insider (july 22, 2017, 10:00 am), http://www.businessinsider. com/instagram-vs-snapchat-which-is-the-better-app-2017-7 /# test-no-1-stories-1 [https://perma.cc/lzc8-4vd6]. 45. id. 46. id. 332 indiana health law review [vol. 16:325 other platforms cuts into its market share.47 these trends may be indicative that, while snapchat, as a platform, could be a fleeting trend, the fundamental features of snapchat will endure in some form. c. physicians incorporating snapchat into practice there have been an emerging number of doctors who are on the forefront of integrating social media into their daily practice. one of the first physicians to gain notoriety for the use of social media was dermatologist sandra lee, m.d. it all started when she got a marked response to a blackhead extraction video uploaded to her youtube channel in december 2014; in response, she created an instagram account dedicated solely to her practice.48 using this platform, she began regularly posting photos and videos of her patients’ dermatological conditions, the treatment provided, and products from her skin care line.49 since then, dr. lee’s social media presence has ballooned to over “3.1 million youtube subscribers, 2.6 million instagram followers, and 2 million facebook fans” as of january 2018.50 inspired by the success of dr. lee, other physicians followed suit, creating social media accounts to educate the public to the services they provide. physicians who turned to social media early on soon realized that the graphic nature of their work could run afoul of community guidelines. plastic surgeon michael salzhauer, m.d., or as his fans know him, dr. miami, began experimenting with snapchat after instagram removed photos from his account in 2015 for violating its terms and conditions.51 the problem? instagram’s community guidelines clearly prohibit users from posting content containing nudity, including “close-ups of fully-nude buttocks.”52 for physicians like dr. miami who showcase work involving nudity, such as breast or buttocks augmentations, such strict guidelines prevented them from making those kinds of posts. however, snapchat has comparatively lax censorship community guidelines—“depictions of nudity in non-sexual contexts are okay.”53 the upshot of this difference in guidelines was that snapchat could be the vehicle for 47. josh constine, what is snapchat, now that story sharing has stopped growing?, techcrunch (jan. 10, 2018), https://techcrunch.com/2018/01/09/the-ever-ending-story/ [https://perma.cc/mk3n-3pna]. 48. liz krieger, this pimple-popping doc is taking over the internet, refinery29 (dec. 18, 2015, 4:30 pm), http://www.refinery29.com/2015/12/99665/sandra-lee-dr-pimple-popperyoutube-star#slide-1 [https://perma.cc/34ah-9ds4]. 49. see sandra lee (@drpimplepopper), instagram, https://www.instagram.com/ drpimplepopper/?hl=en [https://perma.cc/8lad-48hd]. 50. about dr. pimple popper, dr. pimple popper, http://www.drpimplepopper.com/aboutdr-pimple-popper/ [https://perma.cc/5z3l-8n7v]. 51. bryant, supra note 7. 52. community guidelines, instagram, https://help.instagram.com/477434105621119 [https://perma.cc/2qqg-nth6]. 53. id. 2019] #nofilter 333 physicians who wanted to share posts without risk of censure. dr. miami stumbled onto this workaround when he became “the first surgeon to broadcast on [snapchat].”54 matthew schulman, m.d., owner of @nycplasticsurg, was next to follow suit and reported that as of september 1, 2017, his professional snapchat received 4.5 million daily views.55 through the use of snapchat, these and similar physicians have sought to provide a window into their work, allowing followers to see everything from patient check-ups to invasive surgeries.56 physician usage of snapchat highlights an interesting phenomenon which may explain its mass appeal—a glimpse into a physician’s daily routine of checking patients or performing surgeries sharply juxtaposes with the mundane content uploaded by the average user. another crucial difference that plays into the popularity of snapchat physicians beyond that of the average user is “[t]he ‘gawker’ or ‘rubbernecking’ phenomenon, where people can't resist looking at disturbing things.”57 both characteristics help explain the explosive growth rate in followers recently seen by snapchat physicians. 1. the positive role of social media in medicine providers utilizing such platforms have expressed the view that social media can be a useful educational tool, help close the information gap between patients and physicians, and enable patients to gain a realistic understanding as to what exactly certain treatments entail.58 information gaps, or asymmetries, occur when one party to a transaction has greater knowledge than the other. in health care settings, informational asymmetries are common because physicians possess greater medical knowledge than the patient.59 these asymmetries create significant problems because patients end up relinquishing varying degrees of autonomy to the physician when faced with choices related to their care.60 the idea behind closing these gaps is it may ameliorate some of the associated problems by enabling an elevation in the level of discourse between patients and physicians. with this exclusive access to the operating room, prospective patients may 54. kayleen schaefer, how to snapchat a brazilian butt lift: crossing the final privacy frontier with dr. miami, vanity fair (may 13, 2016, 1:42 pm), https://www.vanityfair.com/ style/2016/05/dr-miami-snapchat-plastic-surgery [https://perma.cc/8pcj-33ak]. 55. matthew schulman (@nycplasticsurg), instagram (sept. 1, 2017), h t tps:/ /www.instagram.com/p/byhk1kuh2m3/?hl=en&taken-by=nycplast icsurg [https://perma.cc/ls67-nhsh]. 56. bryant, supra note 7. 57. id. 58. motherboard, meet the plastic surgeon who shares his surgeries on snapchat, youtube (dec. 13, 2016), https://www.youtube.com/watch?v=jjiy0imf25q&index=1&list= plaeofonhyy-0n-0giirnjlvyxgyyi4-xw&t=125s. 59. nicole huberfeld et al, the law of american health care 39 (2017). 60. id. at 38-39. 334 indiana health law review [vol. 16:325 gain a realistic understanding of what they can expect from their own procedures. for example, in an interview, dr. miami iterated his belief that it is a common misconception that operating rooms “are always solemn or intense places,” noting that within his practice, the experience is more akin to what one would have seen when watching the television show m*a*s*h.61 the thinking goes, that exposure to this more realistic portrayal will help patients’ viewpoints to undergo a paradigm shift because what they encounter on snapchat is quite unlike what they have come to expect from watching medical dramas on cable television. further, it can help illuminate the idea of “standard of care” to patients. there is no one definition for the standard of care.62 in indiana, the standard of care for physicians has been described to mean that “a physician must exercise that degree of care, skill, and proficiency exercised by reasonably careful, skillful, and prudent practitioners in the same class to which he belongs, acting under the same or similar circumstances.”63 although it is unlikely that anyone will explicitly describe the standard of care, those who watch may gain a general understanding of what a reasonably prudent physician would do under the circumstances. snapchat’s ability to expose patients to the standard of care renders it a unique and valuable teaching tool. moreover, social media can “enable new ways of access to and sharing of information, social support, emphasize collaboration and participation of the stakeholders involved, and increase individuals’ connectivity and enable users’ direct participation.”64 by affording patients the opportunity to view a physician’s portfolio of work and becoming familiarized with their personality, patients are able to choose physicians whom they find agreeable and who produce the type of results they desire. physicians who have implemented snapchat into their practice have even reported higher booking rates for patients as a result because it serves as a quasiprescreening process before any initial consultation has occurred.65 dr. schulman shared anecdotal evidence regarding how snapchat has impacted his patient population, estimating that about eighty percent of patients who schedule consultations are already following him on snapchat prior to the appointment.66 another aspect of this self-selection is that patients who find physicians through social media are aware of what type of behavior is shown on post content; some call this level of awareness “the ultimate informed consent.”67 61. nick keppler, out-of-control plastic surgeons’ snapchat hijinks are putting patients at risk, lifehacker: vitals (nov. 4, 2017, 12:00 pm), https://vitals.lifehacker.com/out-ofcontrol-plastic-surgeons-snapchat-hijinks-are-pu-1819113914 [https://perma.cc/rzz3-p49p]. 62. peter moffett & gregory moore, the standard of care: legal history and definitions: the bad and good news, 12 western j. emergency med. 109, 109 (2011). 63. vergara v. doan, 593 n.e.2d 185, 187 (ind. 1992). 64. marjorlijn l. antheunis et al., patients’ and health professionals’ use of social media in health care: motives, barriers and expectations, 92 patient educ. & counseling 426, 426 (2013). 65. motherboard, supra note 58. 66. id. 67. keppler, supra note 61. 2019] #nofilter 335 more to the point, familiarization, by way of social media, can make information as to the expected results more readily available, which in turn alleviates patient apprehension. for example, candidates for plastic or cosmetic surgery often experience anxiety before undergoing the procedures because of the known risks involved.68 watching reality television shows that focus on cosmetic surgery is associated with improved attitudes towards these procedures. portraying cosmetic surgery in a positive light increases patients’ receptivity towards subsequent advertising.69 on the other hand, television shows like “botched” have shed light on how complications during surgery or physician negligence can lead to horrible disfigurement, requiring costly revisionary procedures to remedy.70 when candidates review a physician’s work on snapchat, it can alleviate some of that anxiety because they have a better understanding of what type of results the physician can routinely produce and the timeline for any recovery after surgery.71 2. lingering apprehensions related to social media’s use in the background of all this innovation are patient privacy rules that predate social media’s existence. hipaa was enacted nearly two decades ago and saw the addition of a privacy rule in 2003.72 because physicians are posting about patients on social media, it begs the question whether protected health information is being adequately handled.73 in many instances, privacy violations on social media are inadvertent, and the lack of clear social media guidelines for physicians only exacerbates the problem.74 there has also been a concern whether the information posted by physicians to social media not only complies with legal standards, but also meets general standards for ethics and professionalism within the medical community.75 for a topic that has received so much criticism, it is baffling that “there have been no peer-reviewed articles in the plastic surgery literature discussing the ethical implications of such broadcasts.”76 the content physicians post to their social 68. motherboard, supra note 58; marlene rankin & gregory borah, anxiety disorders in plastic surgery, 100 plastic & reconstructive surgery 535, 535 (1997). 69. joshua fogel & kahlil king, perceived realism and twitter use, 134 plastic reconstructive surgery 233, 233 (2014). 70. damien w. riggs & elizabeth peel, tools of critique, in critical kinship studies 51, 51 (2016). 71. motherboard, supra note 58. 72. hipaa history, hipaa j., https://www.hipaajournal.com/hipaa-history/ [https://perma. cc/wnn7-gtdj]. 73. carleen hawn, take two aspirin and tweet me in the morning: how twitter, facebook, other social media are reshaping health care, 28 health aff. 361, 366 (2009). 74. kimbra ratliff, note, hipaa violations on social media: will hhs continue to ignore?, 45 u. mem. l. rev. 633, 648-67 (2015). 75. chretien & kind, supra note 9, at 1413-21. 76. robert dorfman et al., the ethics of sharing plastic surgery videos on social media: 336 indiana health law review [vol. 16:325 media accounts is ordinarily disseminated immediately and rarely undergoes the careful scrutiny applied to other materials distributed, such as journal articles subject to peer review process prior to publication.77 unfortunately, due to the internet’s universality and indelibility, anyone can then access that content at any point in the future, meaning “[t]he spread of inaccurate and misinformation is often a concern when it comes to the social health experience”78 generally, the average person lacks the requisite expertise to discern the reliability or veracity of the medical information he or she comes across on the internet, which is why it is imperative that medical professionals abstain from disseminating false or misleading information. this corrosion of physicians’ credibility or integrity is not the only storm that the medical profession’s image must weather as a result of social media posts. carelessness and bad behavior by physicians or staff in the office also have the potential to be placed on public display virally. there is a great deal of concern “about compromising patient confidentiality, or eroding public confidence in the medical profession through posted content containing profanity, discriminatory language, depictions of intoxication or sexually explicit behavior.”79 while some physicians see their content as a more accurate, genuine representation of their work environment, others view the “tawdry, attention-grabbing tactics” used by some of the most popular accounts as an affront to medical ethics.80 critics concede that images or videos of patients can have educational value; but, when obscene behavior is on display, they worry that such “broadcasts [are] done more for the purposes of entertainment and marketing than education.”81 specifically, when this type of poor behavior is put on display during surgery, it raises concerns of distorting a patient’s understanding of the surgery such that the patient does not appreciate the serious risks involved when “going under the knife, such as infection, excessive bleeding or possibly blood clots.”82 by glamorizing complex surgical procedures in their posts, physicians may inadvertently trivialize procedures and may be complicit in degrading the high standards to which all physicians hold themselves.83 finally, even if a patient gives the physician consent to post content from systematic literature review, ethical analysis, and proposed guidelines, 140 plastic reconstructive surgery 825, 834 (2017). 77. id. at 833. 78. r. craig lefebvre & alexandra s. bornkessel, digital social networks and health, 127 circulation 1829, 1832 (2013). 79. tara fenwick, social media and medical professionalism: rethinking the debate and the way forward, 89 acad. med. 1331, 1331(2014). 80. keppler, supra note 61. 81. marla paul, end to circus in plastic surgery social media videos?, northwestern: northwestern now (oct. 4, 2017, 12:00 pm), https://news.northwestern.edu/stories/2017/ september/end-to-circus-in-plastic-surgery-social-media-videos/ [https://perma.cc/j5tn-rnh8]. 82. id. 83. dimitris reissis et al., advertising on social media: the plastic surgeon’s prerogative, 37 aesthetic surgery j. np1, np1 (2017). 2019] #nofilter 337 their interaction onto social media, some question whether that consent was truly voluntary.84 of note, the physician-patient relationship is inherently hierarchical.85 thus, the worry is that due to this power imbalance between the parties, “[t]he patient may feel coerced—even if subconsciously—to participate in being filmed in order to be a ‘good patient.’”86 iii. regulation of social media in medicine a. hipaa and its privacy rule at its inception, hipaa was originally “created to ‘improve the portability and accountability of health insurance coverage’ for employees between jobs.”87 another goal of the act includes, among other things, the simplification of the administration of health insurance; this has “bec[o]me a vehicle to encourage the healthcare industry to computerize patients’ medical records.”88 hipaa’s privacy rule was added at a later date and stemmed, in part, from concerns “that advances in electronic technology could erode the privacy of health information.”89 although constrained in its reach, hipaa is the most commonly invoked regulation governing health care providers’ ability to disclose their patients’ records and information. when a case is brought in state courts, hipaa does not fully preempt the extant confidentiality laws.90 hipaa is limited in who it applies to. the rule is applicable to covered entities, which are statutorily defined to include health plans, health care clearinghouses, and health care providers that transmit specific information electronically.91 more plainly stated, this designation means hipaa is applicable to people or groups involved in health care, such as physicians, hospitals, insurers, or other similar entities who interact with patients and transmit information about the patient in the normal course of business. 1. uses and disclosure of protected health information hipaa’s privacy rule speaks specifically to what type of information falls under its protection. known as “protected health information” (“phi”), it refers to certain transmitted or maintained information that is identifiable to patients 84. paul, supra note 81. 85. dror limon & salomon stemmer, doctor-patient hierarchy may have a therapeutic role, 351 bmj h6906, h6906 (2015). 86. paul, supra note 81. 87. hipaa history, supra note 72. 88. id. 89. hipaa for professionals, u.s. dep’t of health & human servs., https://www.hhs. gov/hipaa/for-professionals/index.html [https://perma.cc/9gsj-7gfm]. 90. nicolas p. terry, physicians and patients who 'friend' or 'tweet': constructing a legal framework for social networking in a highly regulated domain, 43 ind. l. rev. 285, 316 (2010). 91. 45 c.f.r. §§ 160.102, 160.103 (2017). 338 indiana health law review [vol. 16:325 regarding their health status, provision of health care, or payment for health care, and which is created or received by a health care provider, health plan, employer, or health care clearinghouse.92 the privacy rule bars covered entities from disclosing phi except as the rule permits or requires, or if the entities obtain written authorization from the patient allowing for specific use or disclosure.93 however, the privacy rule does not apply to “de-identified” health information. this type of information is such that the patient’s identity cannot be readily determined if viewed by a third party.94 a covered entity is permitted to use or disclose this information without an authorization, regardless of whether it received the information in de-identified form or if the “entity itself took proper steps to ‘de-identify.’”95 commonly employed techniques for de-identifying written materials include superimposing opaque, black “redacted” bars over anything that could fall under the eighteen types patient identifiers listed in 45 c.f.r. § 164.514(b).96 the same technique can be employed on photographs to obscure facial features, tattoos, or other identifying marks. while it is possible for a covered entity to run afoul of hipaa for disclosing information that has not been properly de-identified, this type of breach represents only a fraction of hipaa breaches. as indicated on the “wall of shame” published on hhs office of civil rights (“ocr”) website,97 many of the larger hipaa breaches involve incidences such as hacking, theft, unauthorized access, or losing a device containing health information.98 when it comes to disclosing phi, the privacy rule differentiates between authorizations and consent.99 providers are permitted, but not required, to get consent to disclose phi when using the information for treatment, payment or 92. 45 c.f.r. §§ 160.103, 164.501 (2017). 93. 45 c.f.r. § 164.502(a) (2017). 94. 45 c.f.r. § 164.514(a) (2017). 95. ratliff, supra note 74, at 642. 96. u.s. dep’t of health & human servs. office for civil rights, guidance regarding methods for de-identification of protected health information in accordance with the health insurance portability and accountability act (hipaa) privacy rule 19 (2012). 97. jessica davis, hhs overhauls 'wall of shame' breach reporting website, healthcare it news (july 26, 2017, 11:29 am), http://www.healthcareitnews.com/news/hhs-overhauls-wallshame-breach-reporting-website [https://perma.cc/uq9c-9pnw]; see also what are the penalties for hipaa violations?, hipaa j., https://www.hipaajournal.com/what-are-the-penalties-for-hipaaviolations-7096/ [https://perma.cc/syk6-xpzd] (mentioning the settlement amounts for certain hipaa violations, including some listed on the ocr “wall of shame.”). 98. breach portal: notice to the secretary of hhs breach of unsecured protected health information, u.s. dep’t of health & human servs. off. for c.r., https://ocrportal.hhs.gov/ ocr/breach/breach_report.jsf [https://perma.cc/cuc5-e4rp]. 99. what is the difference between “consent” and “authorization” under the hipaa privacy rule?, u.s. dep’t of health & human servs., https://www.hhs.gov/hipaa/forprofessionals/faq/264/what-is-the-difference-between-consent-and-authorization/index.html [https://perma.cc/4f77-xwaw] (last reviewed july 26, 2013). 2019] #nofilter 339 health care operations (“tpo”).100 however, a written authorization must be obtained from the individual patient if a covered entity wants to disclose a patient’s phi for any use that is not related to tpo, or if the use is not otherwise permitted or required by the privacy rule.101 for an authorization to be considered valid, it must be in plain language.102 at a minimum, valid general authorizations must contain the following core elements: (1) “[a] description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion;”103 (2) “[t]he name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure;”104 (3) “[t]he name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure;”105 (4) “[a] description of each purpose of the requested use or disclosure. the statement ‘at the request of the individual’ is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose;”106 (5) “[a]n expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure;”107 and (6) “[s]ignature of the individual and date. if the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual must also be provided.”108 in addition to the core elements, valid authorizations must also contain adequate statements to put a patient on notice regarding his or her right to revoke the authorization in writing, “the ability or inability to condition treatment, payment, enrollment or eligibility for benefits on the authorization,” and that “information disclosed pursuant to the authorization [is] subject to disclosure by the recipient and no longer be protected” by the rule.109 if a covered entity seeks authorization from a patient, a copy of the signed authorization must be provided to the patient.110 an authorization to disclose phi must contain all of these elements in order to be deemed valid. 2. marketing in general, authorizations are required under hipaa if the disclosure of phi is for marketing, which is defined as “communication about a product or service 100. id. 101. 45 c.f.r. § 164.508 (2017). 102. 45 c.f.r. § 164.508(c)(3) (2017). 103. 45 c.f.r. § 164.508(c)(1)(i) (2017). 104. 45 c.f.r. § 164.508(c)(1)(ii) (2017). 105. 45 c.f.r. § 164.508(c)(1)(iii) (2017). 106. 45 c.f.r. § 164.508(c)(1)(iv) (2017). 107. 45 c.f.r. § 164.508(c)(1)(v) (2017). 108. 45 c.f.r. § 164.508(c)(1)(vi) (2017). 109. 45 c.f.r. § 164.508(c)(2) (2017). 110. 45 c.f.r. § 164.508(c)(4) (2017). 340 indiana health law review [vol. 16:325 that encourages recipients of the communication to purchase or use the product or service.”111 commonly known examples of marketing include television, radio, printed, and internet advertisements. there are several types of communications excluded from the marketing rule and, therefore, do not require authorization for disclosing phi.112 one of these carve-outs is communications in which the covered entity does not receive financial remuneration for making the communication and, generally, are regarding: the treatment of the individual; a description of a “health-related product or service provided by or included in the covered entity’s plan of benefits;” or case management, care coordination, or information provided on alternative treatments.113 financial remuneration means “direct or indirect payment from or on behalf of a third party whose product or service is being described. direct or indirect payment does not include any payment for treatment of an individual.”114 b. additional guidelines 1. state statutes and case law interpreting hipaa for blatant hipaa violations where patient information is shared without authorization, state statutes may provide further protections. for example, an indiana nursing assistant was charged with felony voyeurism after she posted a photograph of a nursing home patient’s buttocks to snapchat without the patient’s knowledge or consent.115 the incident came to light after it was reported to the nursing home by one of the defendant’s co-workers who received the photo via snapchat.116 when questioned about taking the photograph, the nursing assistant stated she did it “because she thought it would be funny.”117 after the nursing home conducted an in-house investigation, the police became involved.118 under the terms of the plea agreement, the nursing assistant had the charge reduced to a misdemeanor, served one day in jail, was placed on probation for 363 days, had to complete forty hours of community service, and paid a fine.119 in a later interview, the nursing assistant acknowledged that she made a mistake, but also appeared to be dismissive over what transpired, stating “[t]hey just blew everything out of proportion…everybody takes pictures of the residents all the time. i’m not the only one.”120 a propublica investigation involving this case and 111. 45 c.f.r. §§ 164.501, 164.508(a)(3) (2017). 112. 45 c.f.r. § 164.501 (2017). 113. id. 114. id. 115. affidavit for probable cause at 3, indiana v. waller, no. 72d01-1506-f6-137; plea agreement, indiana v. waller, no. 72d01-1506-f6-137. 116. affidavit for probable cause, supra note 115, at 3; plea agreement, supra note 115. 117. affidavit for probable cause, supra note 115, at 3. 118. affidavit for probable cause, supra note 115, at 2. 119. plea agreement, supra note 115. 120. charles ornstein, nursing home workers share explicit photos of residents on 2019] #nofilter 341 other similar hipaa violations in nursing homes, found that, as of the date of its investigation, ocr had not penalized any of the nursing homes for these violations.121 however, upon being alerted to these violations, ocr’s deputy director for health information privacy expressed outrage, stating “[i]f we don’t have pending investigations on any of these cases…they would be candidates for further inquiry.”122 this case is demonstrative that state statutes, include those which impose criminal penalties, can provide recourse for patients who have had their privacy violated. further, indiana has adopted statutes that are substantially similar to portions of hipaa, including core elements for valid authorizations to disclose health information.123 in order to release a patient’s health record with patient consent, the written consent form must include: the patient’s name and address; the name of the entity requested to release the record; the identity of the recipient; a description of why and what it was being released; the signature of the patient or the patient’s legal representative; the date the written consent was signed; a statement acknowledging the patient’s right to revoke consent “at any time, except to the extent that action has been taken in reliance on the consent”; and a statement regarding when the consent will expire.124 these requirements under indiana law have been held to be supplemental to hipaa.125 unfortunately, indiana cases do not provide much aid in interpretation; for example, in cases regarding authorization for disclosure, one must meet the required elements.126 for breach of privacy cases in indiana, little is added to the statute other than interpreting whether the elements for written consent were met.127 one of the few clarifications is that the phrase “to whom it may concern” does not satisfy the requirement that the written consent includes “specific identification of the person authorized to make the disclosure.”128 additionally, generalized language used to describe merely the recipients of the health information does also not count as a description of the purpose for the disclosure.129 while these additions illuminate whether certain statements will satisfy requirements for written consent, there is still a paucity of guidance for authorized disclosures. snapchat, propublica (dec. 21, 2015, 8:00 am), https://www.propublica.org/article/nursinghome-workers-share-explicit-photos-of-residents-on-snapchat [https://perma.cc/rky6-72jm]. 121. id. 122. nursing home snapchat photo sharing scandal uncovered, hipaa j. (dec. 22, 2015), https://www.hipaajournal.com/nursing-home-snapchat-photo-sharing-scandal-uncovered-8229/ [https://perma.cc/gfv8-cjql]. 123. ind. code § 16-39-1-4 (2017). 124. id. 125. jeffrey v. okolocha (in re e.j.), 972 n.e.2d 941 (ind. ct. app. 2012). 126. id. at 945. 127. id. at 945-48; meridian health servs. corp. v. bell, 61 n.e.3d 348 (ind. ct. app. 2016). 128. okolocha, 972 n.e.2d at 947. 129. id. 342 indiana health law review [vol. 16:325 2. administrative guidelines for social media professional and administrative bodies also recognized a growing need for revised health standards as social media grew in popularity. this resulted in many different bodies disseminating suggested guidelines. a common theme among these policies is an emphasis on abstaining from posting patient information.130 this cautious approach can likely be attributed to safeguarding against hipaa breaches.131 the information set out by hhs does not provide definitive measures that providers can implement in order to avoid breaches, but instead intends for the regulations to act as guidance for entities when they craft their own policies.132 lacking clear guidance, providers then act in a tightly controlled manner in order to remain in compliance with hipaa and avoid its costly penalties. hipaa violations are broken down into four categories, in order of severity, with civil penalties ranging from a $100 to $50,000 fine per violation.133 the maximum fine an entity can be assessed per category is $1,500,000.134 in addition, hipaa violations can incur three tiers of criminal penalties with prison sentences up to ten years.135 a. american medical association guidelines in 2010, the ama published its own social media policy, “professionalism in the use of social media,” which attempted to assist physicians in their use of social media.136 this policy contains six provisions, the majority of which are generalized guidelines encouraging professionalism.137 first, the ama guidelines stress the importance of understanding applicable patient privacy and confidentiality standards, including abstaining from posting phi on the internet.138 second, physicians are urged to utilize available privacy settings for social media accounts, be aware of the potential permanency of any content posted, and be vigilant in ensuring their posts are accurate and appropriate.139 130. nicolas p. terry, fear of facebook: private ordering of social media risks incurred by healthcare providers, 90 neb. l. rev. 703, 714 (2012). 131. ratliff, supra note 74, at 654. 132. standards for privacy of individually identifiable health information, 65 fed. reg. 82,462-01, 82,562 (2000) (to be codified at 45 c.f.r. pts. 10 & 164) (“we do not prescribe the particular measures that covered entities must take to meet this standard, because the nature of the required policies and procedures will vary with the size of the covered entity and the type of activities that the covered entity undertakes.”). 133. what are the penalties for hipaa violations?, supra note 97. 134. id. 135. id. 136. terry, supra note 130, at 713. 137. id. 138. professionalism in the use of social media, ama, https://www.ama-assn.org/deliveringcare/professionalism-use-social-media [https://perma.cc/j66t-673y]. 139. id. 2019] #nofilter 343 third, any patient interactions on the internet must conform to professional ethics guidelines which ordinarily exist within the patient-physician relationship.140 fourth, physicians who use social media professionally are encouraged to maintain a professional account separate from their personal account.141 fifth, if a physician becomes aware of unprofessional content posted by a colleague, he or she has an affirmative duty to address the matter with the colleague or, if necessary, to “report the matter to appropriate authorities.”142 finally, it advises of potential negative impacts resulting from social media posts, including tarnishing of reputations and “undermin[ing] public trust in the medical profession.”143 b. federation of state medical boards guidelines similarly, the fsmb articulates the idea that “growing concerns about physician use of social media underscore the need for social media policies.”144 as of 2011, over two-thirds of physicians have created social media accounts for their professional practices, reflecting the widespread appeal of such services.145 what is worrisome is that according to a 2010 survey, ninety-two percent of responding medical boards reported online professionalism violations occurred in their jurisdictions.146 the bulk of the reported violations from the study included inappropriate online communication with patients (69%), “use of the internet for inappropriate practice, e.g., internet prescribing without an established clinical relationship” (63%), and misrepresenting credentials on the internet (60%).”147 these numbers are indicative that the scope of the problem clearly cannot be overstated. fsmb guidelines emphasize the importance of maintaining appropriate physician-patient relationships.148 these guidelines advises physicians that the use of social media ought to be done while adhering to the ethical standards of candor, privacy, and integrity.149 physicians are mandated to protect their patients’ privacy and confidentiality, any breach of which could incur hipaa violations.150 fsmb’s stance is that no verbal patient identifiers should be stated 140. id. 141. id. 142. id. 143. id. 144. federation of state medical boards, model guidelines for the appropriate use of social media and social networking in medical practice 2 (2012). 145. id. 146. id. 147. s. ryan greyson et al., physician violations of online professionalism and disciplinary actions: a national survey of state medical boards, 307 jama 1141, 1141(2012). 148. federation of state medical boards, supra note 144, at 4. 149. id. at 6. 150. id. at 7. 344 indiana health law review [vol. 16:325 and no pictures of patients should be taken.151 although the guidelines delve into implementing those ethical standards, the fsmb is silent regarding situations where a physician receives patient authorization to post the patient’s image on social media.152 fsmb is attuned to the plight of the medical profession in that it cautions all social media posts be checked for clarity and veracity due to their far-reaching and perpetual influence once submitted.153 it takes a stand for the medical profession’s image by ensuring that privacy breaches and bad behavior will be subject to disciplinary action from the appropriate state’s medical board.154 this policy is more expansive than what hipaa alone could safeguard against. by taking a wider stance on physicians’ online activities, the fsmb is attempting to protect the high ethical standards that have taken so long to develop.155 c. other generalized guidelines smaller entities have also begun crafting their own social media policies which largely reflect the guidance provided by the ama and fsmb. the indiana university school of medicine, for example, has created social networking guidelines for its students.156 while the guidelines call for professionalism and ethics while using social networking platforms, it is noticeably lacking in specific, practical guidance to help explain what that looks like and, instead, offers only vague, generalized statements.157 its guidelines serve more as a warning to medical students that there will be internal disciplinary consequences for social media posts “that are either unprofessional or violate patient privacy.”158 it goes on to say that those same posts “can be used in court or other disciplinary proceedings (i.e. state medical licensing boards).”159 regarding confidentiality, the guidelines also briefly mention hipaa and institute a blanket ban on photographing patients without written consent.160 there is no mention of de-identifying photos made in the guidelines, likely out of an abundance of caution.161 the massachusetts medical society has also published social media guidelines.162 unlike many other guidelines, the massachusetts guidelines state 151. id. 152. id. 153. id. at 8. 154. id. at 9. 155. fenwick, supra note 79, at 1331. 156. ind. u. sch. med., social media (2018), https://medicine.iu.edu/wp-content/uploads/ 2018/06/31-social-media.x42491.pdf [https://perma.cc/5yrp-zyek]. 157. id. 158. id. at 2. 159. id. 160. id. at 4. 161. id. 162. hayon, et al., supra note 8, at 2. 2019] #nofilter 345 that “[c]arefully planned and professionally executed participation in social media by physicians is professionally appropriate,” and can offer numerous benefits when executed correctly.163 it also suggests that physicians disclose any applicable conflicts of interest for their posts by disclosing financial relationships that may exist when discussing particular products or services.164 the remainder of the massachusetts guidelines is largely duplicative of the policies set forth in the ama’s guidelines, including the sections regarding confidentiality, utilization of privacy settings, reporting inappropriate content, the impact of social media posts, and maintaining “appropriate boundaries of the patient-physician relationship.”165 massachusetts expands on the recommendation of keeping separate professional and private accounts by spelling out how physicians should only connect with patients on their professional account and not on personal accounts.166 like many other recommendations, the massachusetts guidelines emphasize the importance of de-identifying patient information in order to preserve patient privacy, but they stop short of defining how to do so.167 d. american society of plastic surgery guidelines in light of the generalized guidelines that had been promulgated, the american society of plastic surgeons (“asps”) crafted a set of guidelines that seek to address the problem of inappropriate use of social media in a more direct manner.168 like the other guidelines, these are based on the “four principles of medical ethics [which] include: 1) respect for autonomy of the patient; 2) beneficence or promoting what is best for the patient; 3) nonmaleficence, also known as ‘do no harm’ and 4) justice.”169 what proved challenging in crafting this ethical framework was striking a balance between retaining traditional notions of expected behavior and embracing what it takes to remain relevant in the ever-changing landscape of an evolving society.170 the preamble to the asps code of ethics includes a warning stating that members could face disciplinary consequences, up to expulsion, for breaking any of its principles.171 no physician may reveal patient information without obtaining the proper consent from the patient first.172 in a move demonstrating receptiveness to the current social media climate, the asps does allow physicians to advertise on social media using photographs, so long as it is done in an ethical manner and 163. id. at 12. 164. id. 165. id.; professionalism in the use of social media, supra note 138. 166. hayon, et al., supra note 8, at 12. 167. id. at 2. 168. am. soc’y plastic surgeons, code of ethics of the american society of plastic surgeons 1 (2017). 169. paul, supra note 81. 170. id. 171. am. soc’y plastic surgeons, supra note 168, at 1. 172. id. at 2. 346 indiana health law review [vol. 16:325 cannot be construed as false advertising.173 this conditional acceptance of the practice, rather than outright prohibition, is indicative of a recognition of social media’s intrinsic value. the code of ethics provides a fairly detailed explanation of what the asps considers false advertising.174 in additional to general prohibitions on propagating false or misleading information, these guidelines include other prohibitions such as testimonials or endorsements pertaining to the quality of care if it does not represent the typical results, giving an opinion regarding the superiority of services if that opinion cannot easily be verified publicly, or appealing “primarily to a layperson’s fears, anxieties, or emotional vulnerabilities.”175 in october 2017, some asps members proposed the adoption of additional guidelines in response to the more notorious social media behaviors of some of its members.176 first and foremost, the proposed guidelines stress the importance of obtaining patient consent before making a post.177 every post should be properly de-identified and the patient should reserve the right to revoke the content at any time.178 the patient also should reserve the right to refuse participation in a physician’s post, and that decision should have no bearing on the level of care administered.179 the physician should always warn the patient that even if a post is deleted from the physician’s social media, there is no way to ensure completely that it is gone forever.180 plastic surgeons ought to understand and follow the professionalism standards in the asps code of ethics.181 lastly, the asps suggests its members hire a dedicated social media manager so that patients need not endure any additional time under the knife and physicians do not encounter any needless distractions.182 iv. given what we know, is this overor underregulated? a. the (in)adequacies of federal laws and other guidelines as a means of guidance despite hipaa’s express language regarding when disclosure is or is not appropriate and how to obtain valid authorization for disclosure, the law fails to explain exactly what an authorized disclosure should look like. specifically, indiana statutes and case law discuss the necessary six statutory elements of written consent for getting authorization to disclose health information. indiana 173. id. at 5. 174. id. at 2-5. 175. id. at 4. 176. dorfman et al., supra note 76, at 834. 177. id. 178. id. 179. id. 180. id. 181. id. 182. id. 2019] #nofilter 347 cases have provided some clarity by addressing whether the elements were met, such as specifying that the phrase “to whom it may concern” does not satisfy the requirement that the written consent includes “specific identification of the person authorized to make the disclosure,” and stating that generalized language used to describe merely the recipients of the health information does not also count as a description of the purpose for the disclosure.183 however, neither indiana’s statutes, nor the applicable case law, address what the disclosure of health information should look like once written consent is obtained. moreover, while social media guidelines by administrative authorities stress the need for social media posts to adhere to legal and ethical standards, these vague generalizations provide little understanding as to what an appropriate post of a patient ought to look like in appearance. to provide better guidance over the issue, more governing entities would do well to adopt clearer guidelines similar to asps’s proposed guidelines. b. fear of hipaa violations has led to some prohibitions of physician postings in clinical settings it is not uncommon for large health care organizations to have blanket prohibitions against physicians posting about patients on social media.184 the rationale behind this position is to minimize the risk of “violating federal privacy laws by breaching patient confidentiality.”185 although health care organizations have begun adopting social media policies, there continues to be apprehension towards incorporating its use within clinical settings.186 unsurprisingly, this may explain why many of the physicians who utilize social media in daily practice tend to belong to small practices or are independent physicians, which do not have the same level of administrative red tape. further, social media policies adopted by medical schools and employers must navigate potential legal and constitutional challenge arguments.187 for example, after being disciplined in violation of louisiana state university’s code of conduct, one student raised constitutional challenges to provisions of the code, claiming they were overly broad and vague.188 there, the fifth circuit court of appeals noted that while the code of conduct in question was broadly aimed at “speech or conduct that creates an intimidating, hostile, or offensive environment,” this limitation on speech was permissible because the prohibition was limited to “expression [that is] persistent, extreme or outrageous and 183. jeffrey v. okolocha (in re e.j.), 972 n.e.2d 941, 947 (ind. ct. app. 2012). 184. kimberly danebrock, does your medical office need a social media policy?, healthcare it news (june 1, 2015), http://www.healthcareitnews.com/blog/does-your-medicaloffice-need-social-media-policy [https://perma.cc/d4g4-jk9l]. 185. id. 186. id. 187. terry, supra note 130, at 720. 188. esfeller v. o'keefe, 391 f. app’x 337, 340-41 (5th cir. 2010). 348 indiana health law review [vol. 16:325 ‘reasonably likely’ to cause harassment or intimidation.”189 other challenges to social media policies have claimed they run afoul of the national labor relations act.190 however, it is likely that health care employers can show “an overriding business interest to support policies restricting workplace recordings and social media use given their obligations to protect patient privacy and comply with hipaa.”191 in flagstaff medical center, inc., for example, the national labor relations board (“the board”) upheld a “hospital’s policy prohibiting the recording of images of patients, hospital equipment, property, or facilities.”192 the board acknowledged that “the privacy interests of hospital patients are weighty” and that the hospital had a “significant interest in preventing the wrongful disclosure of individually identifiable health information.”193 given that patient privacy issues are implicated even when a physician seeks to post about a patient using one of hipaa’s safe harbors, it is likely that social media policies crafted by health care organizations will withstand any challenges. c. the good, the bad, and the ugly—examples of social media in practice exemplary uses of social media in medicine easily lend themselves as the embodiments of the positive benefits this technology can bring. there are many snaps uploaded by physicians depicting surgeries where they are explaining each step of the procedure.194 not only does this expand the knowledge and understanding of the viewing audience, but the process of actively explaining each step can work as a mechanism for avoiding careless errors. it is also common for physicians to use specimens removed during surgery to further explain conditions or topics related to or encountered during the procedure.195 patients have reported that the medical education they receive by watching the 189. id. 190. terry, supra note 130, at 722-24. 191. denise dadika, protecting patient privacy in light of the nlrb’s scrutiny of norecording and social media policies, health emp. & lab. (dec. 28, 2016), https://www.healthemploymentandlabor.com/2016/12/28/protecting-patient-privacy-in-light-of-thenlrbs-scrutiny-of-no-recording-and-social-media-policies/ [https://perma.cc/3qxt-xnpr]. 192. id.; see also flagstaff medical center, inc., 357 n.l.r.b. no. 65 (aug. 26, 2011). 193. flagstaff medical center, inc., 357 n.l.r.b. no. 65, 663 (aug. 26, 2011). 194. see chris miller (@drcrmillertime), instagram (june 3, 2017), https://www. instagram.com/p/bu4lsj0gcpw/?taken-by=drcrmillertime [https://perma.cc/27np-zef3] (explaining the subvastus approach to a total knee replacement while pointing out the muscle via manipulation). 195. see cat begovic (@beautybydrcat), instagram (sept. 30, 2017), https://www. instagram.com/p/bzrm46xgkmr/?hl=en&taken-by=beautybydrcat [https://perma.cc/ym654vux] (showing scar tissue removed during capsulectomy and explaining capsular contraction); matthew schulman (@nycplasticsurg), instagram (dec. 1, 2016), https://www.instagram. com/p/bnfxm6jdd0b/?hl=en&taken-by=nycplasticsurg [https://perma.cc/sgj6-x4mg] (showing fold in removed breast implant and explaining how the fold developed and the risks associated). 2019] #nofilter 349 content posted by physicians made them more knowledgeable going into their procedures and even helped relieve anxiety.196 regardless of the benefits, the instantaneous nature of snapchat leaves open the risk of misinformation or inadvertent disclosure of phi. for example, in at least one instance, dr. schulman posted a photo to snapchat of his nurse working on patient charts in her office.197 although no patient information was clearly visible, the possibility of photo enhancing software being used to gather that information is not precluded. other physicians have observed that the absence of peer review for social media posts has enabled some physicians to advocate for certain techniques, practices, or products “as if they were the gold standard” even though the subjects are still up for debate.198 even when physicians obtain authorization to post imagery of patients on social media, the audience is usually unaware of the individual authorization and therefore it is difficult for the average observer to determine whether the post is a hipaa violation or not.199 further complicating the matter, some physicians implement social media policies regarding their disclosure authorizations which allow patients to choose their desired level of privacy, including whether they speak on camera, allow tattoos or their face to be shown, and so on.200 the lack of physician guidance for creating appropriate social media posts has led to problematic content. creation of content not only involves uploading a particular image, but also amplifying it using filters, hashtags, captions, and other features. so far, no physician guidelines explain how to use these in a professional manner, which has led to some posts pushing the boundaries of professionalism. latching onto a popular snapchat filter shortly after its debut in the summer of 2017, dr. miami uploaded to instagram one of his snapchat posts showing a patient in the middle of a “tummy tuck” in which a cartoon dancing hotdog was superimposed over the open abdominal cavity.201 adding to its questionable nature, the hashtag “#litasshotdog” was included with the instagram caption.202 ironically, in an interview with dr. miami, when asked about this incident, he revealed that the patient in the post found the use of this filter hilarious, adding that he has “never had a patient complain about any filter or bitmoji over the last three years.”203 another example of questionable social media practices involves a repeated method used by tarick smiley, m.d. on numerous occasions, dr. smiley has posted videos to his snapchat showing the results of completed buttock 196. motherboard, supra note 58. 197. screenshot of snap by dr. schulman dated sept. 26, 2017 (on file with author). 198. rod rohrich, so, do you want to be facebook friends? how social media have changed plastic surgery and medicine forever, 139 plastic & reconstructive surgery 1021, 1023 (2017). 199. id. 200. screenshot of snap by dr. schulman dated oct. 3, 2017 (on file with author). 201. screenshot of instagram post by dr. salzhauer dated july 13, 2017 (on file with author). 202. id. 203. keppler, supra note 61. 350 indiana health law review [vol. 16:325 augmentations while the patients were still under anesthesia on the operating table with his surgical team dancing in the background to the song “bubble butt.”204 he followed up at least two of the videos with a photograph of the patient before they were taken out of the operating room and emphasized the new projection of the buttocks by placing a downhill skiing emoji parallel to a line tracing the contour.205 the array of social media practices that vary not only between physicians, but also between different posts by the same physician, illustrates a need for clearer professional guidance. v. suggestions to improve physician practices a. adding a mandatory ethics examination for physicians the ama has a code of medical ethics which offers guidance to physicians regarding ethical questions related to the physician-patient relationship.206 while this code of medical ethics is helpful in defining professional standards for physician interactions with patients, not much is said regarding topics outside of clinical practice.207 in contrast, the aba’s model rules of professional conduct are a similar set of ethical guidelines, but covers a more comprehensive set of issues confronted by professionals within the legal field.208 for each respective profession, these ethical codes provide the general basis of understanding for appropriate professional behaviors. in general, the vast majority of states require aspiring lawyers to take the mpre, which examines the understanding of “established standards related to the professional conduct of lawyers” and is based off the aba’s aforementioned model rules.209 the mpre is an examination that is required to practice law in addition to the bar exam. interestingly, although physician board examinations may include a small percentage of questions related to ethics,210 physicians do not have to take and pass an entirely separate examination solely dedicated to ethics 204. video capture of snap by dr. smiley dated oct. 12, 2017 (on file with author); video capture of snap by dr. smiley dated oct. 21, 2017 (on file with author); video capture of snap by dr. smiley dated jan. 9, 2018 (on file with author); video capture of snap by dr. smiley dated feb. 6, 2018 (on file with author). 205. screenshot of snap by dr. smiley dated oct. 12, 2017 (on file with author); screenshot of snap by dr. smiley dated feb. 6, 2018 (on file with author). 206. frequently asked questions on ethics, ama, https://www.ama-assn.org/deliveringcare/frequently-asked-questions-ethics [https://perma.cc/nh44-u4n8]. 207. id. 208. model rules of professional conduct, a.b.a., https://www.americanbar.org/groups/ professional_responsibility/publications/model_rules_of_professional_conduct.html [https://perma.cc/szj4-aykr]. 209. multistate professional responsibility examination, nat’l conf. b. exam’rs, http://www.ncbex.org/exams/mpre/ [https://perma.cc/x4yp-nbx7]. 210. step 2ck: content outline and specifications, u.s. med. licensing examination, http://www.usmle.org/step-2-ck/#contentoutlines [https://perma.cc/5r2d-bumc]. 2019] #nofilter 351 the way that lawyers do. adding an ethics requirement for physicians, which parallels the scope and quantity of the professional ethics examination imposed on lawyers, will likely result in a reduction of ethical breaches committed by physicians. b. the need for more specific guidance as noted above, neither laws nor guidelines have provided practical explanations to help physicians craft appropriate social media posts depicting their patients once authorization for disclosure is obtained. despite continuous emphasis on creating content through a legal and ethical lens, questionable posts by medical professionals continue to make their way onto social media, exemplifying the need for more specific guidance. at the heart of the issue possibly lies the answer as to why eyebrow-raising posts keep happening: how do you keep physicians from posting unprofessional content when it never occurs to them that the content may be viewed as unprofessional in the first place? another contributing factor may be the multiple, and sometimes competing, ways professionalism is defined, especially in light of interdisciplinary areas.211 these concerns are compounded considering the potential issues associated with a patient request to remove content; there is no way to ensure it was removed completely, because other users may have made copies of the post before it is removed.212 a possible solution to the problem is to simply draft updated administrative guidance that explicitly addresses this area. given the ama already has a code of ethics, it seems logical to build upon those. in order to craft a more expansive and informed set of rules while presenting a more united front in the medical community, the ama should get input from other leading medical bodies such as the fsmb. clarifications that would have a positive impact are those that provide explanations regarding when and how to de-identify patient information in social media posts and what that information includes. further, specific recommendations should be made to illustrate what an appropriate post looks like. this would include examples of appropriate captions, word choice, use of photo editing tools such as filters, and so on. if guidelines alone are not enough to deter inappropriate behavior, it is still possible that more active approaches to disseminate information about professional use of social media will yield improved outcomes. one possibility is the implementation of educational requirements for physicians regarding the appropriate usage of social media based on the updated guidelines. c. the imposition of a heightened duty to modify online behaviors one last possibility to make physicians more aware of what kind of content they are posting is to impose a heightened duty on physicians when people reasonably rely on information posted to social media by the physician. as 211. fenwick, supra note 79, at 1332. 212. dorfman et al., supra note 76, at 827. 352 indiana health law review [vol. 16:325 mentioned earlier, the average person lacks the requisite expertise to discern the reliability or veracity of the medical information he or she comes across on the internet, making it imperative that medical professionals abstain from disseminating false or misleading information. it is not uncommon for patients to use the internet to obtain health information. one study found that ninety-five percent of prospective aesthetic surgery patients sought health information online prior to any consultations with a physician.213 undoubtedly, the information obtained by patients influences their decision-making. if the information used in making those decisions is false or misleading, this could potentially lead to detrimental results. the aforementioned existing guidelines for physicians already discourage or prohibit unethical online behaviors. however, considering some physicians still engage in problematic online activities, the deterrence power of these guidelines appears inadequate. it is possible that an imposition of a heightened duty could encourage prudent and cautious social media practices. if enacted, this duty would allow a patient who relied on false or misleading medical advice on the internet and incurred damages as a result to bring a claim against the physician who posted that content on the applicable social media platform. what is not clear is if this duty would have any effect on some of the attention-grabbing tactics physicians on snapchat currently employ. even if those tactics are still used, this imposed duty would encourage such posts to have intellectually honest content. vi. conclusion social media has changed the way in which people communicate and share information. some physicians note that the use of platforms like snapchat can be valuably informative tools when used properly. physicians can use platforms lawfully if hipaa authorizations are obtained from patients. however, it seems the real issues arise when trying to assure that physicians are making posts in an ethical and professional manner. current laws and guidelines provide little assistance; those that do tend to be vague and do not help physicians understand satisfactorily what constitutes a proper post, including phrasing of captions, application of filters, and use of hashtags. given the gap in medical ethics testing, it would seem some of these issues could be best addressed by adopting medical professional ethics testing, similar to the mpre, based on professional guidelines made by the ama. the situation could further be remedied by updating the relevant guidelines. if education is not the heart of the issue, making physicians think twice before posting content could also alleviate the problem. social media has proven to be an effective and useful tool, with little signs of going away anytime soon. given its vast potential to effectuate positive growth within the medical field, it would be unfortunate if this valuable resource went unused due to the unprofessional conduct of a relatively small number of physicians. just as medicine has embraced other emerging technologies, social media ought to be incorporated into daily practice, guided by clear standards. 213. dorfman et al., supra note 76, at 833. professor kinney on the human right to health care: continuing the conversation r. george wright* i. introduction for professor kinney, the idea of a human right to health care was a matter of central and continuing interest.1 rather like a gemologist, professor kinney examined the facets2 of this right with discerning attention. this contribution continues the conversation with professor kinney at fundamental levels.3 professor kinney distinguished, in particular, a human right4 from a natural right;5 international human rights6 from other sorts of human rights;7 and a right * lawrence a. jegen professor of law, indiana university robert h. mckinney school of law. a more extensively documented version of this contribution can be found at the author’s ssrn page. 1. see, e.g., jason t. eberl, eleanor d. kinney & matthew j. williams, foundation for a natural right to health care, 36 j. med. & phil. 537 (2011) [hereinafter foundation]; eleanor d. kinney, health care financing and delivery in the us, mexico and canada: finding and establishing intentional principles for sound integration, 26 wis. int’l l.j. 934 (2009) [hereinafter health care financing]; eleanor d. kinney, the international human right to health: what does this mean for our nation and world?, 34 ind. l. rev. 1457 (2001) [hereinafter international]; eleanor d. kinney & brian alexander clark, provisions for health and health care in the constitutions of the countries of the world, 37 cornell int’l l. j. 285 (2004) [hereinafter provisions]; eleanor d. kinney, realization of the international human right to health care in an economically integrated north america, 37 j. l. med. & ethics 807 (2009) [hereinafter economically]; eleanor d. kinney, realizing the international human right to health for non-citizens in the united states, 1 notre dame j. int’l comp & hum. rts. l. 94, 112 (2011) [hereinafter non-citizens] (“[r]ealizing the international human right to health must be achieved on a global level”); eleanor d. kinney, realizing the international human right to health: the challenge of for-profit health care, 113 w. va. l. rev. 49 (2010) [hereinafter challenge]; eleanor d. kinney, recognition of the international human right to health care in the united states, 60 rutgers l. rev. 335 (2008) [hereinafter united states]. 2. note the range of perspectives taken in the authorities cited supra note 1. 3. thus, our attention is largely confined to the most foundational of professor kinney’s concerns, with special attention to foundation, supra note 1, and with some reference as well to international, supra note 1; challenge, supra note 1; and united states, supra note 1. 4. for merely one instance of a focus on ‘human’ rights without corresponding reference to ‘natural’ rights, see international, supra note 1. 5. much of the focus is explicitly on ‘natural’ rights, specifically in foundation, supra note 1. 6. see, e.g., international, supra note 1; economically, supra note 1. 7. in a sense, any familiar understanding of the idea of a human right implies its applicability beyond the borders of a single state, and thus international. otherwise, the point of referring to a “human,” as distinct from, say, a constitutional right within a legal system, would be unclear. of course, one might refer to “international” human rights for other purposes, such as to 34 indiana health law review [vol. 17:33 to health care8 as distinct from a right to health itself.9 we briefly address these and other arguably even more fundamental issues herein. first, though, we summarize professor kinney’s explication of the idea of a human right to health. this summary draws upon several of professor kinney’s published works,10 with primary attention to her jointly authored article entitled foundation for a natural right to health care.11 in foundation, professor kinney argues that “a fundamental human right to health exists in international law12 and philosophical tradition, and governments are thus obligated to recognize this right through fair and just implementation.”13 officially adopted language has it that “[h]ealth is a fundamental human right indispensable for the exercise of other human rights,”14 and that “every human being is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity.”15 such language is, however, aspirational,16 emphasize questions of the right’s embodiment in international treaties, or its fulfillment through international cooperation. for a mainstream use of the term, “international human rights,” see jack donnelly & daniel j. whelan, international human rights (5th ed. 2017). 8. see, e.g., foundations, supra note 1; economically, supra note 1; united states, supra note 1. 9. see international, supra note 1; non-citizens, supra note 1; challenge, supra note 1. professor kinney recognizes a distinction between health care and health itself, as in, e.g., the very title of provisions, supra note 1. one might distinguish between health care and health itself and regard both as a matter of human right, requiring different forms of recognition and compliance. some writers have emphasized the differences between health care and health itself and would deny human right status to the latter. see, e.g., joseph raz, human rights in the emerging world order, 1 transnat’l legal theory 31, 45 (2010) (“[i]t would be silly to think that people really have a right to be healthy, a right which is violated every time they are not healthy.”); allen e. buchanan, the right to a decent minimum of health care, 13 phil. & pub. aff. 55, 55 (1984) (“i think its implausibility is obvious.”). 10. see in particular the sources cited supra note 3. 11. foundation, supra note 1. 12. for some of the most directly relevant united nations declarations and covenants, see g.a. res. 217 (iii) a, universal declaration of human rights (dec. 10, 1948) (art. 25 in particular); international covenant on economic, social and cultural rights, dec. 16, 1993, 393 u.n.t.s. 3; comm. on econ., soc. and cultural rights, general comment no. 14: the right to the highest attainable standard of health (art. 12), u.n. doc. e/c.12/2000/4 (aug. 11, 2000). for useful summaries, see eibe riedel, the human right to health: conceptual foundations, in realizing the right to health 21 (andrew clapham et al. eds., 2009); michael krennerich, the human right to health: fundamentals of a complex right, in healthcare as a human rights (sabine klotz et al. eds., 2017). 13. foundation, supra note 1, at 553. 14. id. at 538-39. 15. id. (quoting comm. on econ., soc. and cultural rights, supra note 12, ¶ 1). see also paul hunt & gunilla backman, health systems and the highest attainable standard of health, in realizing the right to health, 40 (andrew clapham et al. eds., 2009). 16. foundation, supra note 1, at 539. 2020] professor kinney on the human right to health care 35 in the sense that no present society is thought to be in full compliance.17 crucially, if a right to health or to health care is not universally recognized, or if there is disagreement as to the meaning of the right, it is important to be able to articulate the most basic and most persuasive justification of the right in question.18 professor kinney recognizes the diversity of possible basic justifications for health or health care rights.19 apart from appeals to particular religious doctrines, professor kinney notes in particular the possibility of deontological20 and even utilitarian21 attempts to justify human rights jurisprudence.22 the focus of professor kinney and her colleagues is thus on the idea of a fundamental justification of a basic human right to health or to health care. one such possible justification is said by professor kinney to draw upon the natural law tradition,23 both historic24 and as revised by contemporary theories of basic human capabilities25 and self-realization.26 a natural law approach to justifying human rights claims to health or to health care should, at a minimum, properly account for the universality of the 17. id. 18. see id. 19. id. at 540. 20. see larry alexander & michael moore, deontological ethics, stan. encyclopedia of phil. (oct. 17, 2016), https://plato.stanford.edu/entries/ethics-deontological [https://perma.cc/ 7uxc-krmu]. 21. see julia driver, the history of utilitarianism, stan. encyclopedia of phil. (sept. 22, 2014), https://plato.stanford.edu/entries/utilitarianism-history [https://perma.cc/6fkc-ttg2]. for a broader survey of influential schools of normative ethics, see shelly kagan, normative ethics 189-299 (1997); marcia w. baron, philip pettit & michael slote, three methods of ethics (1997) (adding aretaic or virtue-based normative ethics to the mix). if familiar forms of utilitarianism can justify universal human rights, so, one might ethical theories that treat the cultivation of familiar virtues as central. see rown cruft et al., philosophical foundations of human rights (2015). 22. foundation, supra note 1, at 540. 23. id. at 538. 24. see id. at 543-47. 25. see id.; martha c. nussbaum, creating capabilities: the human development approach (2013); amartya sen, the idea of justice ch. 2 (2011); efrat ram-tiktin, the right to health care as a right to basic human functional capabilities, 15 ethical theory & soc. prac. 337 (2012). 26. see id. for discussions of self-realization, self-actualization, or self-fulfillment in broader ethical and political contexts, see, e.g., john stuart mill, on liberty (gertrude himmelfarb ed. 1975) (1859); t.h. green, prolegomena to ethics (1883). see also, david o. brink, perfectionism and the common good: themes in the philosophy of t.h. green (2003); thomas hurka, perfectionism (1993); steven wall, perfectionism in moral and political philosophy, stan. encyclopedia of phil., https://plato.stanford.edu/entries/perfectionism-moral [https://perma.cc/4bj7-r63g] (last updated dec.15, 2017). 36 indiana health law review [vol. 17:33 right, across cultures and degrees of economic, scientific, and technological development.27 but that natural law justification should also recognize the ways in which the right must have a variable and pluralistic dimension, in properly accommodating differences among cultures and their degrees of economic, scientific, technical development.28 for some purposes, settling upon some specific deep justification for a human right to health care may not much matter.29 but any putative human right, certainly including health care, will quickly become controversial along many substantive fronts.30 some31 form of a fundamental justification aspiring to objectivity32 and universality33 then becomes indispensable. a right to health care, whether objectively morally grounded or not, is said to be fundamental in that it is “indispensable for the exercise of other human rights.”34 more broadly, a natural law theorist in particular might defend a right to some level of health care as conducive not necessarily to the best balance of pleasure over pain,35 but to promoting the good of person and the transcending common good.36 historically, pursuit of a presumed common good has been central to the natural law tradition, as in thomas aquinas.37 for aquinas, bodily 27. see foundation, supra note 1, at 543. 28. see id.; international, supra note 1, at 1467. 29. see foundation, supra note 1, at 542 (referring to mary ann glendon’s discussion of jacques maritain’s report of the diversity of motivating principles underlying international endorsement of some basic human rights). see also mary ann glendon & seth d. kaplan, renewing human rights, first things (feb. 2019). 30. see foundation, supra note 1, at 538-39. 31. id. at 540 (listing deontological, utilitarian, and natural law approaches to justifying human rights claims and responsibilities). 32. see id. at 548. see generally lorrain daston & peter galison, objectivity (2007) (for an account of recent understandings of the idea of objectivity in and beyond the moral realm); calder v. bull, 3 u.s. 386 (1798) (iredell, j., dissenting) (for skepticism of the natural law in the united states jurisprudential context); oliver wendell holmes, jr., natural law, 32 harv. l. rev. 40 (1918). 33. see generally immanuel kant, groundwork of the metaphysics of morals (mary gregor & jens timmermann eds., 2d ed. 2012) (1785). 34. foundation, supra note 1, at 538. by loose analogy, consider the constitutional status of the right to vote in state elections as preservative of other important rights. see, e.g., harper v. virginia state bd. of elections, 383 u.s. 663, 667 (1966) (quoting reynolds v. sims, 377 u.s. 533, 561-62 (1964); yick wo v. hopkins, 118 u.s. 356, 370 (1886). 35. as in some crude versions of utilitarianism. see jeremy betham, the principles of morals and legislation (prometheus 1988) (1781). 36. see foundation, supra note 1, at 542 (citing the modern natural law theorist jacques maritain). see also john finnis, natural law and natural rights 125-54 (paul craig ed., 2d ed. 2011). 37. see, e.g., thomas aquinas, summa theologica, part i-ii, question 90, art. 2, respondio (kevin knight ed. 2017) available at www.newadvent.org/summa/2090.htm [https://perma.cc/6sha-q7ke] (“the law is chiefly ordained to the common good”) (linking the 2020] professor kinney on the human right to health care 37 integrity and bodily health are among the most fundamental of all goods.38 how the crucial good of bodily39 health is to be promoted, pursuant to thomistic natural law, is then open to a range of interpretations. aquinas may be best interpreted as neither incapable of following the logic justifying economic markets, nor incapable of profound critique of markets.40 one striking result is aquinas’s conclusion that in some cases, desperate needs to sustain minimal bodily well-being cannot so much override, but fundamentally transform, the basic laws of individual property.41 neither the classical tradition42 nor professor exercise of reason, the common good, and promoting ultimate happiness or well-being). from among a vast critical and expository literature, see, e.g., john finnis, aquinas: moral, political, and legal theory (1998); the ethics of aquinas (stephen j. pope ed. 2002). for a more modern but related argument, see daniel m. hausman, a lockean argument for universal access to health care, 28 soc. phil. & pol’y 166, 166 (2011). 38. see aquinas, supra note 37, part i-ii, question 94, art. 2, respondio (on the most basic goods to be sought pursuant to the natural law). 39. aquinas is, of course, concerned here not only with bodily health and integrity, but with psychological health, and with health of character. see aquinas, supra note 37, part i-ii, questions 55-66. see also john budziszewski, commentary on thomas aquinas’s virtue ethics (2017). 40. for an exceptionally worthy discussion of aquinas’s appreciation for and fundamental critique of market operations and outcomes, see generally mary l. hirschfield, aquinas and the market: toward a humane economy (2018). see also, for more contemporary perspectives, first charles e. lindblom, the market system: what it is, how it works, and what to make of it (2001), and then, conflictingly, jason brennan, why not capitalism? (2014); g.a. cohen, why not socialism? (2009); friedrick a. hayek, the road to serfdom (1945); john for a classic instance of what is often mistakenly thought of as an optional private redistribution of resources, see st. cardinal bonaventure, the soul’s journey into god, the tree of life, and the life of st. francis 254 (paulist press ed., ewart cousins trans.) (1978) (1263).e. roemer, a future for socialism? (1994); ludwig von mises, socialism: an economic and sociological analysis (j. kahane tras.1962); friedrick a. hayek, the use of knowledge in society, 35 am. econ. rev. 519 (1945); oscar lange, on the economic theory of socialism: part one, 4 rev. econ. stud. 53 (1936); oscar lange, on the economic theory of socialism: part two, 4 rev. econ. stud. 123 (1937); abba p. lerner, economic theory and socialist economy, 2 rev. econ. stud., 51 (1934). for a brief but even-handed account of the “socialist calculation” debate, see allen buchanan, ethics, efficiency, and the market 10917 (1988). 41. see aquinas, supra note 37, part ii-ii, question 66, art. 7, respondio. see also john chrysostom, discourse ii, in on wealth and poverty 3 (st. vladimir’s seminary press 1999) (~390). professor kinney and her colleagues cite aquinas’s discussion of surplus private property as genuinely owned by a person with no alternative to meeting their immediate desperate need, foundation, supra note 1, at 547. 42. for a classic instance of what is often mistakenly thought of as an optional private redistribution of resources, see st. cardinal bonaventure, the soul’s journey into god, the tree of life, and the life of st. francis 254 (paulist press ed., ewart cousins trans.) 38 indiana health law review [vol. 17:33 kinney herself assumes, however, that crucial bodily health needs must be met in all instances by some form of direct governmental provision.43 the traditional natural law concepts of the common good, human flourishing, and the fullest development of human capacities have recently been taken up in the ‘capabilities’ approach of writers such as martha nussbaum.44 professor kinney interprets the capabilities approach to individual flourishing45 and the common good46 as implying certain basic rights and corresponding obligations.47 among the most fundamental elements of flourishing is, as professor nussbaum argues,48 bodily health.49 this fundamental capability then implies certain associated rights. ultimately, professor kinney and her colleagues again recognize an international near consensus “that a fundamental human right to health exists in international law and international law and philosophical tradition, and governments are thus obligated to realize this right through fair and just implementation.”50 this defense of a human right to health care, however, is hardly universally accepted. consider in particular the broad critique of human rights theory and practice of professor eric a. posner.51 posner argues that: [t]he proposition that all people enjoy a specified set of human rights . . . is highly controversial among philosophers. the absence of an agreed upon philosophical justification for human rights yields well-known (1978) (1263). 43. see challenge, supra note 1, at 59, 64-5. see also foundation at 553 (ultimately, “a fundamental human right to health exists in international law and philosophical tradition, and governments are thus obligated to realize this right through fair and just implementation,” but “the realization of human rights, even the provision of benefits to individuals, does not necessarily require that government do the providing.”). the nature, efficacy, and meaning of health care in the thirteenth century are in some, but certainly not all, respects different in contemporary health care systems. see, e.g., paul starr, the social transformation of american medicine 3-28 (2017 ed.). 44. see, e.g., martha nussbaum, creating capabilities: the human development approach ch. 2 (2013) [hereinafter creating capabilities]; martha nussbaum, capabilities and human rights, 66 fordham l. rev. 273, 287 (1997) (referring to “bodily health” as “being able to have good health, including reproductive health; to be adequately nourished; to have adequate shelter”). see also ram-tiktin, supra note 25. 45. foundation, supra note 1, at 550. 46. id. 47. id. 48. see sources cited supra note 44. 49. creating capabilities, supra note 44, at 33. 50. foundation, supra note 1, at 553. 51. see generally eric a. posner, human welfare, not human rights, 108 colum. l. rev. 1758 (2008) [hereinafter human welfare]; eric a. posner, the twilight of human rights law (2014). 2020] professor kinney on the human right to health care 39 practical difficulties: states disagree about which rights are human rights, about which human rights should have priority, about how resources should be allocated for the purpose of correcting human rights violations, and about how much respect should be given to cultural variation.52 below, we continue the conversation with professor kinney as to these and other points. ii. the distinctive foundations of human rights claims in general professor kinney understandably seeks to justify claims of a human right to health care as securely as possible. her preference, as we have seen,53 is for an updated natural law-based approach. natural law theories of any sort are at present not generally favored, even among loosely sympathetic writers.54 almost every conceivable approach to justifying human rights claims is endorsed somewhere in the relevant literature.55 but it seems doubtful that any metaphysically less ambitious approach to justifying human rights claims can, over time, supply the motivation for substantial self-sacrifice for the sake of remote strangers.56 professor james griffin in particular has argued that the underlying logic and justification of human rights claims historically drew crucially upon theology,57 with a familiar later transition toward secularity.58 but “[w]hen during the seventeenth and eighteenth centuries the theological content of the idea [of 52. human welfare, supra note 51, at 1760 (footnote omitted). 53. see supra section i. 54. see, e.g., vittorio bufacchi, theoretical foundations for human rights, 66 pol. stud. 601 (2017) (avoiding a natural law approach in favor of a ‘deflationary’ theory relying on social construction and convention). 55. for leading contemporary contributions, see generally charles r. beitz, the idea of human rights (2009); jack donnelly, universal human rights in theory and practice (2013); james griffin, on human rights (2008); rhoda e. howard-hassmann, in defense of universal human rights (2018); human rights futures (stephen hopgood et al. eds., 2017); samuel moyn, not enough: human rights in an unequal world (harvard univ. press 2018); james nickel, making sense of human rights (2d ed. 2007); michael j. perry, toward a theory of human rights: religion, law, courts (2007); philosophical foundations of human rights (rowan cruft et al. eds., 2015); henry shue, basic rights: subsistence, affluence, and u.s. foreign policy (2d ed. 1996); carl wellman, the moral dimensions of human rights (2010); bufacchi, supra note 54; joseph raz, human rights without foundations (oxford legal stud., research paper no. 14/2007, 2007), https://ssrn.com/abstract=999874 [https://perma.cc/a2xl-243l]. 56. for a brief discussion, see griffin, supra note 55, at 1-2; see also infra note 123 and accompanying text. 57. see griffin, supra note 55, at 1. 58. see id. at 1-2. 40 indiana health law review [vol. 17:33 human rights] was abandoned, nothing was put in its place.”59 over the past century or so, the historic theological realism and then the succeeding secular realism once thought to validate human rights claims has increasingly been abandoned in favor of a variety of less ambitious approaches to justifying human rights, if not to disposing of the project of justification. ultimately, the meaning, weight, and bindingness of claims as to human rights depend upon the metaethics underlying those claims. the less ambitious the metaethical grounding, the less binding the substantive human rights claim is likely to be.60 thus, historic forms of moral realism have given way to a continually splintering variety of less ambitious61 metaethical approaches. among the current rubrics would be anti-realism, constructivism, some forms of contextualism, conventionalism, some forms of deflationism, emotivism, reductive and eliminative materialism, metaethical minimalism, non-cognitivism, pragmatism, projectivism, quasi-realism,62 and moral skepticism, pyrrhonian63 or otherwise.64 contemporary advocates of these variously diluted metaethical views do not invariably abandon the use of terms such as ‘inviolable,’ ‘inviolability,’ or the ‘sacred,’ that one might well associate with a more ambitious metaethics.65 whether any attenuated metaethics can fully cash the checks written by terms such as ‘inviolability’ is doubtful. but the long-term observance of progressive human rights norms may ultimately depend on just such matters. the less ambitious approaches to the metaphysics of human rights do have a long history. merely for example, consider the classic atoms-and-the-void 59. id. at 2. 60. but see the implicit argument to the contrary in the arguably misleadingly titled article by ronald dworkin, objectivity and truth: you’d better believe it, 25 phil. & pub. aff. 87 (1996) (the net value of professor dworkin’s references to ‘objectivity’ is limited). see, e.g., robert d. sloane, human rights for hedgehogs?: global value pluralism, international law, and some reservations of the fox, 90 b.u. l. rev. 975, 989 (2010). 61. or if technically not less realist, then self-stultifying as justifications for human rights claims. see generally, e.g., john mackie, ethics: inventing right and wrong (1977) (the “error theory,” as well as the non-cognitivist approach). 62. many of these categories overlap. see generally, e.g., simon blackburn, essays in quasi-realism (1993) (projectivism and quasi-realism). 63. see generally, e.g., pyrrhonian skepticism (walter sinnott-armstrong ed. 2004). 64. nearly all of these rubrics are addressed in the online stanford encyclopedia of philosophy. stanford encyclopedia of philosophy, https://plato.stanford.edu/ [https://perma.cc/ w58e-jxbh]. for more a comprehensive treatment of metaethics, see generally, e.g., andrew fischer, metaethics: an introduction (2014); simon kirchin, metaethics (2012); andrew miller, contemporary metaethics: an introduction (2013); mark van roojen, metaethics: a contemporary introduction (2015). on constructivism and conventionalism in human rights theory, see generally bufacchi, supra, note 54. 65. see generally, the relevant writings of dworkin, supra note 60; ronald dworkin, religion without god (2013). 2020] professor kinney on the human right to health care 41 metaphysics of the poet lucretius.66 lucretius famously adopts a rigorous materialism of mind, arguing that the building blocks of all things in nature are called, “according to our needs, matter, atoms, generative bodies, elements and seeds, and first-beginnings, since it is from these that all proceeds.”67 more simply, “the universe’s nature consists, in essence, of two different things: for there is matter, and there is void, in which the particles of matter move hither and thither.”68 the mind itself is said by lucretius to consist entirely of matter, in the form of minute particles.69 the problem is that thinking of the mind as consisting of minute particles, even at the quantum level, does not seem to leave much room for classic freedom of the will,70 for classical moral responsibility,71 or for a genuinely binding morality of any familiar human rights.72 hence the current dilemma for advocates, including professor kinney, of any sort of natural law-oriented basis for human rights claims, including a human right to health care. contemporary culture tends to view natural law theories of any political valence as unpersuasive, incredible, or realistically unavailable.73 but many of these same critiques of even the most appealing versions of natural law theory can be readily applied as well to any approach to metaethics that could 66. see lucretius, the nature of things (alicia stallings trans., penguin classics ed., 2007) (~50 bce). 67. id. at 4-5. this thoroughgoing materialism does not, however, prevent lucretius from then almost immediately invoking ideas such as impiety, sin, wickedness, wrongfulness, and defilement. these terms are broadly inconsistent with pure materialism, at least as these ideas are normally understood. see dworkin, supra note 65. 68. lucretius, supra note 66, at 5 (“[a]nd specifically, ‘material makes up the composition of the mind’”). id. at 77 (in particular, the mind consists of minute “particles”). 69. id. 70. see e.g., anthony r. cashmore, the lucretian swerve: the biological basis of human behavior and the criminal justice system, proceedings of the nat’l acad. of sci. u.s.a. (jan. 12, 2010), www.pnas.org/cgi/doi/10.1073/pnas.0915161107 [https://perma.cc/72cz-9luk]. the “lucretian swerve” is drawn from lucretius, lucretius, supra note 66, at 77. 71. see bruce n. waller, against moral responsibility ch. 2 (2011). 72. see, e.g., richard garner, beyond morality (temple univ. press, 1994); the end of morality: taking moral abolitionism seriously (richard garner & richard joyce eds., 2019); richard joyce, the myth of morality (2007); alex rosenberg, the atheist’s guide to reality: enjoying life without illusions (2011). see generally r. george wright, criminal law and sentencing: what goes with free will?, 5 drexel l. rev. 1 (2012). there is a tendency at present to believe that if all versions of morality were universally, consistently, and deeply rejected, life would be either largely unaffected or else more humane. 73. see mackie, supra note 61 (providing a classic statement). see also the authorities cited supra note 73. it is certainly possible that a thoroughly de-moralized society could make some provision for the health care of persons, perhaps based on reciprocal altruism, where such a policy promoted the evolutionary adaptive fitness of health care donors. see generally robert l. trivers, the evolution reciprocal altruism, 46 q. rev. biol. 35 (1971). 42 indiana health law review [vol. 17:33 vindicate, in any meaningful way, human rights in general, or a human right to health care in particular. iii. the human right to health care and the conflicting understandings of fair equality at a more practical level, but still of fundamental importance, is the question of the concrete meaning of fairness and equality in the distribution of health care. as it turns out, the alternative approaches to fairness and equality in health care rights parallel those that seek to concretely interpret the general idea of equality itself. unfortunately, in neither the context of health care access nor in that of the idea of equality itself have the leading contemporary scholars reached anything remotely like a consensus.74 with some oversimplification, understandings of fairness and equality in the context of health care rights fall into five largely distinct families. in roughly descending order of stringency, these five families may be thought of as follows: first are the approaches to health care rights that we may think of as especially rigorous and demanding with respect to genuine equality of distribution.75 second are the approaches that we may refer to as “prioritarian.”76 third is the family of approaches referred to as “sufficientarian” in character.77 fourth, there is the family of approaches that ranges, within the category itself, from something like “decency”78 in provision, to some forms of mere minimalist provision,79 as in a minimalist focus on public health matters such as sanitation and vaccinations against contagious diseases. fifth, and finally, there is the category of what we might call mere formalism in the provision of health care.80 these five contending schools of thought regarding the meaning of fairness and equality in health care rights track their counterparts in the broader debates over equality more generally. writers such as g.a. cohen81 and philippe van parijs82 are sometimes thought of, for example, as relatively stringent egalitarians. 74. see r. george wright, equal protection and the idea of equality, 34 l. & ineq. 1 (2016). linking the idea of equality with avoiding (improper) discrimination, however, carries us only so far. see george j. annas & wendy k. mariner, (public) health and human rights in practice, 41 j. health pol., pol’y & l. 129, 136 (2016). 75. see infra notes 81-83 and accompanying text. 76. see infra notes 84-86 and accompanying text. 77. see infra notes 87-88 and accompanying text. 78. see infra notes 89-92 and accompanying text. 79. see id. 80. see infra note 93 and accompanying text. 81. see, e.g., g.a. cohen, rescuing justice and equality (2008) (a generally left-critique of rawlsianism). see also dani filc, the liberal grounding of the right to health care: an egalitarian critique, 112 theoria 51 (2007). 82. see, e.g., philippe van parijs, real freedom for all: what (if anything) can justify capitalism? (1995). any health care system that bars supplemental payments or payments outside that system has the potential for a meaningful equalization of the available medical care, 2020] professor kinney on the human right to health care 43 a desire for as strict an egalitarianism as is feasible tells us little, however, about how to address, at the same time, arguable inequalities among young and old, the healthy and the terminally ill, gender differences, justice and equality between generations, and the health care needs of those persons severely disabled from birth whose circumstances can be improved to widely varying degrees.83 prioritarianism, in contrast, does not invariably endorse every possible move in the direction of greater equality.84 prioritarians point out that it is possible to increase equality in some respect mainly at a disproportionate cost to persons who are themselves not especially well off, in some supposedly absolute and noncomparative sense.85 prioritarians thus give some unspecified degree of preference to the less well off, while avoiding unduly rigid forms of egalitarianism as well as any forms of utilitarianism.86 sufficientarianism, in contrast, holds in the health care context that what is morally crucial about distributions is not precisely the contrast between equality and any degrees of inequality, but between having enough—a genuine sufficiency—and having too little—an insufficiency.87 one problem for sufficientarians, however, concerns how to approach a hypothetical problem in which an inevitable part of the cost of moving some health care recipients from barely below sufficiency to barely at sufficiency is the worsening, to one degree at least in some respects. of course, these restrictions themselves would not begin to address inequalities of various sorts as between young and old, or between persons who are variously severely disabled versus those who are not. for background, see, e.g., norman daniels, just health: meeting needs fairly (1st ed. 2007); tom l. beauchamp & james j. childress, principles of biomedical ethics (7th ed. 2012); robert m. veatch, justice and the right to health care: an egalitarian account (t.j. boll & w.b. bondeson eds., 1991). 83. see cohen, supra note 81. see also r. george wright, can health care law and policy be guided by basic values?: the crucial role of perfectionist solidarity, 86 u. cin. l. rev. 971 (2018). 84. see generally derek parfit, equality and priority, 10 ratio 202 (1997); derek parfit, another defense of the priority view, 24 utilitas 399 (2012); richard norman, equality, priority and social justice, 12 ratio 178 (1999); michael weber, prioritarianism, 9 phil. compass 756 (2014). 85. the claim that the “absolute” aspects of someone’s circumstances can be disentangled from the relative or comparative aspects of their circumstances may not be merely mistaken, but importantly mistaken, especially if values such as community, solidarity, and fraternity are taken seriously. see fred hirsch, social limits to growth 27 (routledge 2nd ed.1978) (on “positional” goods and services). 86. see sources cited supra note 84. 87. among today’s leading sufficientarians are harry frankfurt and george sher. see, e.g., harry g. frankfurt, on inequality (2015); harry frankfurt, equality as a moral ideal, 98 ethics 21 (1987); george sher, equality for inegalitarians (2014). sufficientarians also tend to rely on a distinction between someone’s comparative position, relative to others, and the goodness or badness of one’s circumstances in some absolute sense. see also ram-tiktin, supra note 25. 44 indiana health law review [vol. 17:33 or another, of the health care rights of some even worse-off persons.88 closely akin to sufficientarianism is an approach that emphasizes something like a decent minimum89 of realistic access to health care. this approach, like prioritarianism and sufficientarianism, inevitably suffers from a certain vagueness.90 the primary concern here, though, is whether a decent minimalism, especially if construed as requiring less than genuine sufficiency, meets even the current international law requirements regarding health care rights.91 after all, those requirements have sometimes been ambitiously summarized in terms of aspiring to the “highest attainable”92 standard of health. finally, a right to health care might be treated in largely formalist terms, with proper accounting for the positive and negative externalities associated with one’s health, including the effects of one’s own health on the health of non-consenting third parties.93 whatever their merits, such approaches amount less to interpretations of a substantive human right to health care than to a denial of such a right. 88. such a move, however otherwise morally unattractive, would decrease the number of persons below sufficiency, while moving no one from the category of sufficient health care to insufficient health care. see shlomi segall, why inequality matters: luck egalitarianism, its meaning and value (2016) (discussing several approaches). 89. see, e.g., stephen nathanson, equality, sufficiency, decency: three criteria of economic justice, 30 j. phil. res. 367 (2005); see, e.g., allen e. buchanan, the right to a decent minimum of health care, 13 phil. & pub. aff. 55 (1984) (discussing access specifically in the health and healthcare context); gary e. jones, the right to health care and the state, 33 phil. q. 279, 279 (1938) (citing charles fried, equality and rights to health care, 6 hastings ctr. rep. 29 (1976)). 90. in many contexts, vague categories are neither refinable nor dispensable. see generally timothy williamson, vagueness ch. 1 (1994). 91. while the right to health is not to be understood as a right to be healthy, the right in question has been formulated as “the right to the highest attainable standard of health.” see comm. on econ., soc. & cultural rights, general comment no. 14: right to the highest attainable standard of health (art. 12), u.n. doc. e/c.12/2000/4 (aug. 11, 2000) (discussing article 12 of the international covenant on economic, social and cultural rights) (emphasis in the original). see also international, supra note 1, at 1470 (providing kinney’s thoughts on general comment 14). 92. see, international, supra note 1, at 1470. whether this stringent interpretation is persuasive is considered by, see, e.g., buchanan, supra note 89, at 56; raz, supra note 9, at 45 (we should reject the highest attainable standard test if taken to refer to what is factually attainable); jonathan wolff, the demands of the human right to health, 86 proc. aristotelian soc’y 217, 222 (2012) (citing onora o’neill, the dark side of human rights, 81 int’l aff. 427 (2005)). while all rights require some ranking and prioritization as among themselves, a right to health care may require, or presuppose, fulfillment of a broad range of partly competing economic and social rights. 93. for a sophisticated libertarianism, see, e.g., robert nozick, anarchy, state & utopia (1974). for skepticism as to demanding forms of a right to health care, see, e.g., richard d. lamm, the case against making healthcare a “right,” 25 hum. rts. 8 (1998). 2020] professor kinney on the human right to health care 45 one important problem attending fair equality in general and health care rights in particular, whatever the interpretation, has to do with problems of free, responsible, voluntary risky choices and bad outcomes. these problems are addressed in what is called “luck egalitarianism.”94 while luck egalitarian concerns apply to a wide range of contexts, they apply with particular force to the logic of health care rights. meaningfully pursuing any implications of luck egalitarianism herein would be impossible.95 but to continue the conversation in which professor kinney engages, we need only point to some basic unresolved problems. very roughly, a simple form of luck egalitarianism would notice that some bad health outcomes seem to have nothing to do with any responsible choices on the part of the person suffering the bad, and perhaps expensive, health condition. being born with a serious and continuing physical disability could fall into this category. on the other hand, many people would distinguish such cases from those in which the bad health outcome seems to result from a different kind of luck, in which the adversely affected party seems to have deliberately, knowingly, understandingly, voluntarily, freely, and responsibly assumed the risk of precisely the kind and severity of the bad health outcome that happened to result. which activities, if any, fall into the latter category remains controversial. perhaps we might think of an undistracted veteran professional skier who falls and breaks a leg on a well-tended ski run. but how should we classify cases of familiar sorts of occupational diseases, or addictive cigarette smoking? many choices are constrained and conditioned by one’s social and economic circumstances. even one’s apparent capacity for effort and initiative may reflect the first or non-responsible sort of luck. a further complication is that some risky behaviors may result in not only foreseeable kinds and degrees of harms to health, but in much more severe and more expensive health harms than the actor could reasonably have foreseen. a luck egalitarian approach to such injuries might or might not subsidize the treatment of all of the harm in such cases, or at least treatment for the harm attributable to unforeseeable consequences of the actor’s choices. and more broadly, luck egalitarianism must at some point confront issues of moral hazard96 94. the idea of luck egalitarianism was initially associated with its evolving use by professor ronald dworkin. see, e.g., ronald dworkin, equality, luck and hierarchy, 31 phil. & pub. aff. 190 (2003). for comprehensive accounts, see segall, supra note 88; richard arneson, rethinking luck egalitarianism and unacceptable inequalities, 40 phil. topics 153 (2012); nicholas barry, reassessing luck egalitarianism, 70 j. pol. 136 (2008); marc fleurbay, freedom with forgiveness, 4 pol., phil. & econ. 29 (2005); kok-chor tan, a defense of luck egalitarianism, 105 j. phil. 665 (2008); peter vallentyne, brute luck, option luck and equality of initial opportunities, 112 ethics 529 (2002). for a concise overview, see kasper lippert-rasmussen, justice and bad luck, stan. encyclopedia of phil. (2005), https://plato.stanford.edu/ entries/justice-bad-luck [https://perma.cc/8u6a-zgwd]. 95. for a useful start, see sources cited supra note 94. 96. see, e.g., amy finkelstein, moral hazard in health insurance (2014). 46 indiana health law review [vol. 17:33 and of the logic of mercy and solidarity underlying opportunities for bankruptcy.97 each of these concerns requires continuing conversation among proponents and critics of any form of a human right to health care. but there are also unresolved questions regarding the crucial dependencies of health, and health care, on a wide range of other rights and statuses, as well as of the international redistribution of resources that may be required by a human right to health care. we briefly continue the conversation on these themes below. iv. the human right to health care: interdependencies with other rights and statuses and the question of international resource redistribution among the continuing conversational threads is the relations between health and the social and economic determinants of health, quite apart from health care and medical treatments. it has been suggested that public health, and certainly individual health, is less a function of what we normally classify as health care than of what we might call the social and economic determinants of health. health care by itself obviously does not even approach ensuring one’s health.98 nor is one’s health invariably dependent upon one’s personal health care.99 health tends, plainly, to reflect social advantages and disadvantages along several axes, including economic class, education, place of residence, race, and gender.100 some of these social determinants seem to combine the operations of luck101 with prevailing patterns of broader dominance and subordination.102 97. see, e.g., shlomi segall, in solidarity with the imprudent: a defense of luck egalitarianism, 33 social theory & prac. 177 (2007). 98. see, e.g., kimberley brownlee, do we have a human right to the political determinants of health?, in philosophical dimensions of human rights ch. 28 (rowan cruft et al. eds., 2015); d. robert macdougall & griffin trotter, rights and basic health care, 36 j. med. & phil. 529, 531 (2011); barbara wilson, social determinants of health from a rights-based approach, in realizing the right to health, 60 (andrew clapham et al. eds., 2009). 99. see sources cited supra note 98. thus, the familiar adverse selection effect of many healthy young adults declining to buy health insurance, given their priorities, thereby raising insurance premiums for others, and perhaps impairing the viability of the health insurance scheme in question. see, e.g., timothy j. layton, randall p. ellis & thomas g. mcguire, measuring efficiency of health plan payment systems in managed competition health insurance markets (nat’l bureau of econ. research, working paper no. 21531, 2015), https://www.nber.org/ papers/w21531.pdf. 100. see, e.g., kathryn strother ratcliff, the social determinants of health: looking upstream (2017); donald barr, health disparities in the united states: social class, race ethnicity & health, (2nd ed. 2014). see also norman daniels, just health (2008) (elaborate treatment of health in the context of inequalities of opportunity). 101. see supra notes 94-97 and accompanying text. 102. see, e.g., the authorities cited supra note 100; jayna fishman & douglas mackay, rawlsian justice and the social determinants of health, 36 j. applied phil. 608 (2018). 2020] professor kinney on the human right to health care 47 it is not simply that health, or the lack thereof, affects and is crucially affected by the other rights and opportunities. actually, “if other factors matter more to health than health care, it is not at all evident that it is health care and not those other determinants [of health] that should be redistributed.”103 perhaps societies that value health are best advised not to focus, primarily, on health care itself, but on the crucial social and economic sources of illness, disease, and poor health.104 or put in terms of rights, a right to health care is perhaps best not merely supplemented by, but subordinated to, a right to fair social and economic opportunity in other basic respects.105 dramatically put, it has thus been argued that “society does more to move its citizens toward their fair share of health when it devotes the equivalent of the health care budget to improving the social determinants of health than when it runs a national health care system.”106 or more dramatically yet, insofar as the focus is on fair opportunity in advanced societies, “an equal opportunity account requires that society spend none of its health budget on health care and all of it on ameliorating the social determinants [of ill health] instead.”107 on such a view, it is thus possible that recognizing and directly fulfilling a human right to health care may actually lead to a worse distribution of health than might otherwise be available. public investments in health care may in practice not pay off as well as public investments elsewhere, precisely in terms of improved health. of course, the sheer magnitude of the resources available to promote health matters as well. and the magnitude of resources available to promote health, directly or indirectly, is of especially vital concern in cases of developing economies. in a developing country, the meaning of a human right to health care crucially depends upon whether the pool of available resources is confined largely to local wealth, or else includes substantial international transfers, of one sort or another, as well. as a leading contemporary philosopher has put the issue: is this right only a right to the standard of health that a person can attain with locally available and affordable treatment – however meagre that 103. macdougall & trotter, supra note 98, at 531. 104. see id. 105. see daniels, supra note 100; filc, supra note 81; gopal sreenivasan, health care and equality of opportunity, 37 hastings ctr. rep. 21, 27 (2007). for a more skeptical view of the social determinants argument, see adina preda & kristin voigt, the social determinants of health: why should we care?, 15 am j. bioethics 25 (2015) (changes in wealth and income inequalities may be only poorly related to health outcomes). 106. sreenivasan, supra note 105, at 27. we assume here that the incentive effects of both approaches are equal. 107. see id. (emphasis in the original). sreenivasan recognizes as well that one’s ill health, as in the case of a congenital disability, may affect one’s opportunities to some degree independently of the society’s accommodation thereof. 48 indiana health law review [vol. 17:33 me be? or is it a right to the highest108 available globally109 – however expensive that may be?110 this question leads to the further question of the most morally persuasive approach to required public and private wealth transfers from relatively rich to poor on a global basis.111 it may well be that the moral demands of such wealth distribution are greater than is commonly acknowledged.112 the conversation regarding the redistributive requirements of a human right to health care should, clearly, continue. as a final suggestion for the moment, consider that some global health care problems must be addressed as we are now, with only our currently available resources, whether those resources are to be redistributed internationally or not. a current epidemic, for example, must be addressed largely in the present. that epidemic cannot be put on pause until we have generated additional resources to devote to prevention and cure. but in other contexts, the tradeoffs between immediately addressing a health care problem full on, and instead only mitigating such current harms while also more rapidly building our collective resources for a more successful longer-term confrontation, may be dramatic. generally, effective prevention and cure of major diseases becomes more feasible as the relevant societies make genuine progress economically, scientifically, and technologically.113 with continuing and compounding genuine economic growth and progress, what seems unrealistic in the moment may become readily manageable some limited number of years in the future. medical care that is currently impossible, or at best heroically demanding, may become feasible, routine, relatively cheap, and uncontroversially deliverable. more broadly, it is argued that: the history of economic growth114 indicates that, with some 108. or if not the “highest,” at least some ambitious standard. 109. “global” might conceivably refer to the attained, or attainable, standard of the single leading nation-state in this respect, or to something akin to a weighted or unweighted global average. 110. see onora o’neill, the dark side of human rights, 81 int’l aff. 427, 429 (2005). 111. from among a substantial literature, see generally garrett cullity, the moral demands of affluence (2004); tim mulgan, the demands of consequentialism (2005); peter unger, living high and letting die: our illusion of innocence (1996); richard j. arneson, what do we owe to distant needy strangers?, in peter singer under fire: the moral iconoclast faces his critics 267 (jeffrey a. schaler ed. 2009); brad hooker, the demandingness objection, in the problem of moral demandingness ch 8, at 149 (t. chappell ed. 2009). classically and influentially, see peter singer, famine, affluence, and morality, 1 phil. & pub. aff. 229 (1971). 112. see the authorities cited supra note 111. 113. these forms of genuine progress would reflect the broader enlightenment project of gradually developing the individual and collective capacities of the human mind. see, e.g., jeanantoine-nicolas de caritat, marquis de condorcet 1743-1794, outlines of an historical view of the progress of the human mind 8, 237 (ulan press 2012) (1796). 114. this author seeks sustainable long-term growth, but only in a refined sense of “growth,” 2020] professor kinney on the human right to health care 49 qualifications, growth alleviates misery, improves happiness and opportunity, and lengthens lives. wealthier societies have better living standards, better medicines, and offer greater personal autonomy, greater fulfillment, and more sources of fun.115 similarly, the point has been made that whether we welcome or object to the direct, indirect, or unintended results of technology, the idea of genuine technological progress itself seems to open the door to worthy projects.116 whatever possibilities technological progress destroys, the idea of genuine progress refers ultimately refers to reducing mere waste,117 in the sense of gains in the efficiency with which the inputs needed to make goods and services are reduced.118 the formerly impossible then becomes possible, and even inexpensive, with the health results then depending partly on our willingness to redistribute the necessary resources to pay for such care to the less well off. of course, the choice to advance medical and other technologies may imply other, perhaps less appealing effects.119 new technologies of health care may require the abandonment of privacy.120 and if we emphasize unduly that tomorrow’s economic, scientific, and technological progress will make health care more effective, less expensive, or less burdensome for the donors, we may then rationalize our unwillingness to redistribute resources to combat serious health crises today.121 given the lack of consensus on this among other vital issues, the best collective choice at the moment would seem to involve continuing the ongoing as distinct from mere gnp-based statistics. 115. tyler cowen, stubborn attachments 33 (2018); cowen in turn cites, e.g., steven pinker, enlightenment now: the case for reason, science, humanism, and progress ch. 6 (2018) (on health in particular); benjamin m. friedman, the moral consequences of economic growth ch. 4 (2006). 116. see enrique martinez-garcia, technological progress is key to improving world living standards, 8 fed res. bank of dallas 4 (june, 2013) https://www.dallasfed.org/research/ eclett/2013/el1304.cfm [https://perma.cc/g6dv-4n3u]. 117. see id. at 1. 118. see id. 119. for a classic discussion, see jacques ellul, the technological society (john wilkinson trans., vintage ed. 1984) (1964). 120. for current concerns, see, e.g., brett friedman & jennifer romig, insight: top 5 privacy and security challenges for adopters of blockchain technology in health care, bloomberg l. (july 17, 2018), https://news.bloomberglaw.com/health-law-and-business/insighttop-5-privacy-and-security-challenges-for-adopters-of-blockchain-technology-in-health-care [https://perma.cc/a9ut-qqqt]. 121. this question also implicates the problem of choosing an optimal social discount rate, which might include a rate of zero. for discussion, see cowen, supra note 115, at ch. 4; andrew caplin & john leahy, the social discount rate, (the nat’l bureau of econ. res., working paper no. 7983, 2000), www.nber.org/papers/w7983 [https://perma.cc/qme5-kp5y]. 50 indiana health law review [vol. 17:33 conversation. v. conclusion professor kinney’s largely natural law-based122 approach to an international human right to health care is a vital contribution to an ongoing conversation. as one interlocutor has concluded, those “who complain that we lack adequate philosophical foundations for the broad range of human rights recognized in international law are right. developing such foundations, if possible, is a worthy task. . .”123 one possible way to usefully continue professor kinney’s conversational thread would be to try to take the edge off of the debates over philosophical justifications,124 alternative meanings of equality,125 and a variety of redistributional questions126 by emphasizing the appeal of what we might call a broadened sense of solidarity, community, and of (gender-neutral) fraternity.127 perhaps some of the sharpest conflicts could be mitigated by attending to the role and value of these values.128 the thought here is that values such as solidarity are akin to contested notions of equality, but helpfully refer to much more concretely experienced relationships. there may well thus be contexts in which solidarity is of greater consequence, descriptively and normatively, than typically abstract understandings of equality and inequality.129 and part of the real value of equality 122. as elaborated in terms of the development and preservation of basic human functional capacities. see sources cited supra note 25; norman daniels, just health 316 (2008) (focusing in part on “protecting normal functioning”). 123. daniels, supra note 122, at 314. perhaps out of a sense of the likely futility of any such quest, these basic questions are set aside by philosophical pragmatists and others. see, e.g., jonathan wolff, the human right to health 19-20 (2012) (“[p]robably the right response . . . is . . . to acknowledge the limits of philosophical argument and allow the resulting disputes to be resolved through the development of democratic policies and legal doctrine”). see also raz, supra note 55, at 14, 19 (on a “political” conception, “human rights need not be universal or foundational,” or for that matter, “very important”). but see griffin, supra note 54, at 1. it is not obvious on what edifying and non-arbitrary grounds a “political” debate over human rights is then to be conducted. in the absence of any pursuit of genuinely better human right policies, the default motivator may be not a generous universalism, but perceived group interest. 124. see supra section ii. 125. see supra section iii. 126. see supra section iv. 127. for a more elaborate treatment, see wright, supra note 83. 128. for a useful conceptual exploration, see andrew mason, community, solidarity and belonging: levels of community and their normative significance (2000). 129. see r.h. tawney, equality 113 (unwin ed. 1971) (1951). 2020] professor kinney on the human right to health care 51 may be in helping to generate relationships of friendship, solidarity, and community bonds.130 solidarity may require, for example, a limitation on narrow self-interest,131 even to the point of meaningful self-sacrifice.132 130. see, e.g., jean hampton, political philosophy 154 (1997) (referring to aristotle on equality and the value of community friendships); elizabeth s. anderson, what is the point of equality?, 109 ethics 287, 288-89 (1999) (egalitarianism as properly “to create a community in which people stand in relations of equality to others”). 131. see andraes eshete, fraternity, 35 rev. metaphysics 27, 28 (1981); lawrence crocker, equality, solidarity, and rawls’ maximin, 6 phil. & pub. aff. 262, 263 (1977). 132. consider the possibilities for reciprocal self-sacrifice by both providers and recipients of expensive end-of-life health care, given the emotional stakes and the alternative uses for such funding. the worst of health: law and policy at the intersection of health & immigration wendy e. parmet* this symposium, the intersection of immigration law and health policy, could not be timelier. almost every day since president trump’s inauguration, the news has brought yet another story about immigration and health: we hear about children dying while in the custody of the border patrol1 and about the long-term health effects of children who were separated from their parents at the border.2 we read about immigrant minors being denied access to reproductive health services,3 and about children being stopped by immigration and customs enforcement (“ice”) on their way for emergency surgery.4 physicians report that fearful patients are failing to show up for their medical appointments,5 and * jd, harvard law school; ba cornell university. mathews university distinguished professor of law and professor of public policy & urban affairs, northeastern university. many thanks are owed to meagan antonellis, gabrielle ramussen and genna selesnick for their excellent research help. 1. maria sacchetti & robert moore, after 2nd child dies in u.s. custody, nielsen expands medical screenings, will head to border, wash. post (dec. 26, 2018), https://www. wash ingtonpost .com/local/ immigrat ion /2018/12/26 /e7b262d4-0926-11e9-85b641c0fe0c5b8f_story.html?utm_term=.7cf0df273ba3 [https://perma.cc/vay8-sk4d]. 2. shadi houshyar, family separation is harmful to children’s health, families usa (june 2018), https://familiesusa.org/product/family-separation-harmful-children%e2%80%99shealth [https://perma.cc/y26k-f5hl]. separation from a parent can have dire consequences on a child’s health. “in the short-term, children may exhibit loss of appetite, difficulty sleeping, regressive behaviors, and physical symptoms such as stomachaches and detachment—all common signs of post-traumatic stress disorder in young children. in the longer term, family separation can have negative impacts on both the emotional and physical health and well-being of separated parents and children.” id., see also samantha artiga & barbara lyons, family consequences of detention/deportation: effects on finances, health, and well-being, henry j. kaiser fam. found. (sept. 18, 2018), https://www.kff.org/disparities-policy/issue-brief/family-consequencesof-detention-deportation-effects-on-finances-health-and-well-being/ [https://perma.cc/8j6q-aq95]. 3. see, e.g., supreme court issues decision in jane doe abortion case, aclu (june 4, 2018), https://www.aclu.org/news/supreme-court-issues-decision-jane-doe-abortion-case [https://perma.cc/kxs9-5ujx]. 4. see, e.g., barbara campbell, girl detained by border patrol after emergency surgery released to parents, nat’l pub. radio (nov. 3, 2017, 8:06 pm), https://www.npr.org/ sections/thetwo-way/2017/11/03/562003841/girl-detained-by-border-patrol-after-emergencysurgery-is-released-to-parents [https://perma.cc/69sp-jl6t]. 5. see jan hoffman, sick and afraid, some immigrants forgo medical care, n.y. times (june 26, 2017), https://www.nytimes.com/2017/06/26/health/undocumented-immigrants-healthcare.html [https://perma.cc/5jkn-s63h]; see also ike swetlitz, immigrants, fearing trump’s deportation policies, avoid doctor visits, stat (feb. 24, 2017), https://www.statnews.com/ 2017/02/24/immigrants-doctors-medical-care/ [https://perma.cc/y47g-w8r7]; barrett newkirk, ‘i can’t imagine the fear.’ threat of deportation is keeping immigrant patients away from california medical clinics, desert sun (apr. 18, 2017), https://www.desertsun.com/story/ 212 indiana health law review [vol. 16:211 researchers report that immigrants have refused to enroll their infants in child nutrition programs for fear that doing so could lead to their own deportation.6 hospitals and other health care providers worry about workers, whose ability to remain employed may be threatened by the possible termination of daca,7 or who may be unable to come to this country and provide care because of the travel ban or cut backs on visas.8 meanwhile the administration has proposed new proposed public charge regulations, which if promulgated, may cause millions of lawfully present immigrants to forego a broad array of programs that support health, including medicaid and food stamps.9 all of these incidents, and many more, illustrate that when nativist immigration policy meets health law, health policy and public health tend to suffer.10 the health care system covers fewer people, while becoming costlier and less efficient.11 public health is also jeopardized as punitive and futile efforts to keep diseases out by excluding or punishing newcomers replace evidence-based public health solutions.12 more subtly, when immigration and health policy meet, we lose sight of why the health policy exists in the first place is lost.13 this essay explores these issues, examining why and how laws and policies at the intersection of health and immigration are frequently problematic for both health policy and public health. part i begins by noting that the troubling relationship between immigration and health law is both longstanding and news/health/2017/04/17/immigration-fears-health-coachella/304874001/ [https://perma.cc/wd4rws3g]. 6. study: following 10-year gains, snap participation among immigrant families dropped in 2018, am. pub. health ass’n (nov. 12, 2018), https://www.apha.org/news-andmedia/news-releases/apha-news-releases/2018/annual-meeting-snap-part icipat ion [https://perma.cc/7hhk-7wz8]. 7. see debra f. weinstein & fidencio saldana, daca and the dream of becoming a physician, 377 new eng. j. med. 1913, 1913 (2017). 8. see what do immigrant doctor’s bring to america?, the immigrant doctors project, https://immigrantdoctors.org [https://perma.cc/kn34-22m2]. 9. samantha artiga, rachel garfield, & anthony damico, estimated impacts of the proposed public charge rule on immigrants and medicaid, henry j. kaiser fam. found. (oct. 11, 2018), https://www.kff.org/disparities-policy/issue-brief/estimated-impacts-of-the-proposedpublic-charge-rule-on-immigrants-and-medicaid/ [https://perma.cc/tz5x-9r7l]. see infra text accompanying notes 106-44, for a further discussion. 10. my co-author patricia illingworth and i explored these issues more fully in our book, the health of newcomers: immigration, health policy, and the case for global solidarity (2017). much of the discussion that follows is based on arguments that are developed more fully in the book. 11. see infra text accompanying notes 59-81. 12. see, e.g., angela perone, from punitive to proactive: an alternative approach for responding to hiv criminalization that departs from penalizing marginalized communities, 24 hastings women’s l.j. 363, 379-83 (2013). 13. see infra text accompanying notes 145-60. 2019] the worst of health 213 international in scope.14 parts ii and iii explore the impact of the interjection of immigration policy into health law, discussing in part ii how it adds to the complexity and inefficiency of the health care system15 and in part iii, how it harms public health.16 part iv elucidates those claims further by exploring the potential health impact of the proposed public charge regulations.17 part v concludes by arguing that the battles over immigration and health both reflect and shed light on deeply-seated divisions over the nature of community, the scope of solidarity, and the underlying rationale for health policy and law.18 i also argue that health laws’ treatment of immigrants forces us to consider the basic rationales for health law. that inquiry offers the possibility of a richer and deeper appreciation of the ethical foundations for health law. i. an enduring and universal tempest the contentious relationship between immigration and health policy did not begin with the trump administration. the belief that noncitizens (documented and undocumented) are undeserving of publicly-supported health programs and create a threat to the public’s health has long influenced u.s. health policy. space permits only a brief survey. in the nineteenth and early twentieth centuries, immigrants to the united states were frequently blamed for epidemics, and were routinely subjected to excessively harsh, punitive, and largely ineffective public health policies, such as quarantine.19 perhaps the best-known, but not the only, example of this was san francisco’s treatment of chinese-americans and chinese immigrants when bubonic plague struck the city in 1900.20 rather than viewing residents of chinatown as victims of the plague, city and federal health officials treated them as dangerous vectors, or sources of contagion, and ordered chinese-americans and other residents of asian descent to be inoculated with an experimental vaccine, known as the haffkine prophylactic.21 when that order was struck down by a federal court as violating the fourteenth amendment, officials responded by imposing a quarantine, that was enforced only against individuals of asian ancestry. this led a chinese immigrant, jew ho, to bring yet another lawsuit. once again the order was struck down as “unreasonable, unjust, and 14. see infra text accompanying notes 19-57. 15. see infra text accompanying notes 58-81. 16. see infra text accompanying notes 82-105. 17. see infra text accompanying notes 106-44. 18. see infra text accompanying notes 145-60. 19. illingworth & parmet, supra note 10, at 52-61. 20. for a fuller discussion, see, e.g., marilyn chase, the barbary plague: the black death in victorian san francisco passim (2004); nayan shah, contagious divides: epidemics and race in san francisco’s chinatown 120-57 (2001). 21. see wong wai v. williamson, 103 f. 1, 6 (c.c.n.d. cal. 1900). the incident also reveals the racist roots of many anti-immigrant policies. 214 indiana health law review [vol. 16:211 oppressive.”22 san francisco was not the only jurisdiction to blame immigrants for an epidemic. indeed, many of the most famous targets of coercive public health measures, from henning jacobson, who was criminally charged for refusing to be vaccinated for smallpox,23 to mary mallon, a.k.a. typhoid mary, who was quarantined for life for spreading typhoid fever,24 were immigrants. this is no coincidence. throughout u.s. history, immigrants were viewed as inherently dangerous sources of contagion who had to be subjected to highly coercive measures in order to protect the health of native-born citizens. the belief that immigrants are the source of disease is not only evident in the disparate application of coercive public health measures to immigrants, it is also apparent in our immigration laws. from their very inception, u.s. immigration laws tried to keep out immigrants who were thought to carry dangerous diseases or burden the nation with their ill health. indeed, even before congress regulated immigration, the states used their police powers to inspect passengers for disease and restrict entry of immigrants who were considered dangerous sources of infection.25 these practices were upheld by the supreme court in 1837 in mayor of new york v. miln.26 describing the federal immigration power in 1889, the supreme court stated, “there has never been any question as to the power to exclude [immigrants]. the power is constantly exercised; its existence is involved in the right of self-preservation.”27 a few years later, the supreme court affirmed a louisiana regulation that barred healthy immigrants from entering parts of the state in which there were communicable diseases.28 as the state saw it, immigrants added “fuel to the flame.”29 likewise, from its inception, federal immigration law attempted to protect public health by keeping out immigrants who were viewed as either dangerous to the public’s health or unproductive due to their own ill health. the immigration 22. jew ho v. williamson, 103 f. 10, 26 (c.c.n.d. cal. 1900). 23. jacobson v. massachusetts, 197 u.s. 11, 13 (1905); wendy e. parmet, richard a. goodman, & amy farberal, perspective: individual rights versus the public’s health–100 years after jacobson v. massachusetts, 352 new eng. j. med. 652 (2005). 24. judith walzer leavitt, typhoid mary: captive to the public’s health passim (10th ed. 1997). 25. illingworth & parmet, supra note 10, at 32-33. 26. see generally, new york v. miln, 36 u.s. 102 (1837). as the federal government asserted greater authority over immigration and quarantine at the border, the court came to see these issues as falling within the power of the federal government. see, e.g., hines v. davidowitz, 312 u.s. 52, 62 (1941) (“that the supremacy of the national power in the general field of foreign affairs, including power over immigration, naturalization and deportation, is made clear by the constitution, was pointed out by authors of the federalist in 1787, and has since been given continuous recognition by this court.”). 27. chae chan ping v. united states, 130 u.s. 581, 608 (1889). 28. compagnie francaise de navigation a vapeur v. la. board of health, 186 u.s. 380, 397 (1902). 29. id. at 399. 2019] the worst of health 215 act of 1882 excluded from admission into the u.s. “any convict, lunatic, idiot, or any person unable to take care of himself or herself without becoming a public charge.”30 in 1891, congress barred those “suffering from a loathsome or a dangerous contagious disease,” as well as “insane persons, paupers or persons likely to become a public charge.”31 in 1893, congress authorized federal officials to conduct overseas medical examinations.32 in the years that followed, thousands of immigrants were denied the right to travel to the united states as a result of these inspections. for example, in 1907, more than 35,000 immigrants were denied passage to the u.s. from italy alone.33 those who arrived faced humiliating, publicly-visible medical inspections at ports of entry, including at ellis and angel islands.34 during these examinations, inspectors relied on manuals that were heavily infused with explicit racial assumptions about the health and emotional character of immigrant populations.35 in hindsight, it is hard to see how these measures preserved the nation’s health. few immigrants were actually excluded on health-related grounds; moreover, the examinations were poorly suited to prevent the spread of tuberculosis, influenza, or the other infectious diseases that were most prevalent and dangerous during the early twentieth century.36 instead, examiners focused on trachoma, which was most prevalent in parts of the country that had few immigrants.37 rather than preserve the public’s health, the examinations were designed to keep out those who were thought to be unproductive, while reaffirming to all immigrants their lowly and tenuous status in their new country. the conflation of immigration and health policy, and the erroneous perception that immigrants pose a unique danger to the public’s health, has not disappeared with the advent of modern public health science. in arguing for money to build a wall at the southern border, president trump claimed, “people with tremendous medical difficulty and medical problems are pouring in, and in many cases it’s contagious.”38 likewise, federal immigration law continues to confuse immigration control with communicable disease control. for example, the immigration and naturalization act (ina) excludes immigrants with a “communicable disease of public health significance.”39 although that term is 30. immigr. act § 2, ch. 376, 22 stat. 214 (1882). 31. act of mar. 3, 1891, ch. 551, § 1, 26 stat. 1084 (1891). 32. act of mar. 3, 1893, ch. 206, § 1, 27 stat. 569 (1893). 33. amy l. fairchild, science at the borders: immigrant medical inspection and the shaping of the modern industrial labor force 59 (2003). 34. id. at 86-98. 35. id. at 160-89, 194-209. 36. illingworth & parmet, supra note 10, at 36. 37. id. at 35. 38. philip bump, trump’s arguments for necessity of border wall have already been broadly debunked, wash. post (dec. 11, 2018), https://www.washingtonpost.com/politics/ 2018/12/11/trumps-arguments-necessity-border-wall-have-already-been-broadlydebunked/?utm_term=.6b440e812164/ [https://perma.cc/tqh4-h8va]. 39. immigration and nationality act, 8 u.s.c. § 1182(a)(1)(a)(i) (2013). 216 indiana health law review [vol. 16:211 currently applied narrowly to relatively rare diseases that are not already endemic within the u.s., such as ebola, the law gives the president sole discretion to determine the list of excludable diseases.40 in addition, the ina continues to exclude immigrants (with certain exceptions) who are found likely to become a public charge.41 in making that determination, the act directs officials to consider an immigrant’s health status.42 perhaps the most disturbing example of the conflation of public health policy and immigration in the modern era concerned the treatment of hiv positive haitian refugees in the 1990s. long after hiv was endemic in the u.s., and thus the nation could not be kept free of aids by keeping immigrants out, and well after health officials had warned that discrimination and stigmatization could hamper prevention efforts,43 congress barred noncitizens with hiv from visiting or immigrating to the u.s., and the federal government quarantined hiv positive refugees from haiti at guantanamo bay, cuba,44 an action that presaged the later use of guantanamo as a prevention detention, or quarantine, camp for suspected terrorists. anti-immigrant sentiment has also influenced immigrants’ access to health programs. for example, in 1994, following a campaign that claimed that immigrants were a drain on the state’s health care system, california voters enacted proposition 187, which barred undocumented immigrants from accessing health public benefits, and required health care workers, among others, to report those they suspected of being undocumented.45 although proposition 187 was quickly enjoined by the courts, and never went into effect, it paved the way for the 1996 federal personal responsibility and work opportunity reconciliation act (prwora), which established significant limits on the eligibility of immigrants, both undocumented and lawfully present, to federally-funded health 40. see u.s. citizenship & immigration servs., pol’y manual, communicable disease of public health significance (2018), https://www.uscis.gov/policymanual/html/ policymanual-volume8-partb-chapter6.html [https://perma.cc/st8c-m6cd] (noting that the president may add to the hhs designated list of relevant communicable diseases via executive order). 41. immigration and nationality act, 8 u.s.c. § 1182(a)(4)(a) (2013). 42. id. see infra text accompanying notes 106-44, for a further discussion of the public charge exclusion. 43. presidential commission on the human immunodeficiency virus epidemic, report of the presidential commission on the human immunodeficiency virus epidemic 128-30 (1988), https://files.eric.ed.gov/fulltext/ed299531.pdf [https://perma.cc/6hvr-hzzr]. 44. lynne duke, haitian refugees with hiv remain in limbo as asylum claims stall, wash. post (aug. 7, 1992), https://www.washingtonpost.com/archive/politics/1992/08/07/haitianrefugees-with-hiv-remain-in-limbo-as-asylum-claims-stall/84203872-0b08-4306-9e0ec4e6c0055327/?utm_term=.709800567a9f [https://perma.cc/f25p-dv6z]. 45. ca’s anti-immigrant proposition 187 is voided, ending state’s five-year battle with aclu, rights groups, aclu (july 29, 1999), https://www.aclu.org/news/cas-anti-immigrantproposition-187-voided-ending-states-five-year-battle-aclu-rights-groups [https://perma.cc/am3jt3qf]. 2019] the worst of health 217 benefits.46 then came the 2008 financial crisis. faced with budgetary pressures, states across the nation moved to further cut health benefits for immigrants.47 for example, massachusetts, which extolled its adoption of so-called universal health care in 2006,48 cut back on that promise, cutting classes of legal immigrants who were barred from federally-funded benefits from the state’s forerunner of what became the aca exchanges.49 perhaps most importantly, in the summer of 2009, when the bill that became the affordable care act (aca) was being debated across the country, its opponents rallied around the erroneous claim that it would cover undocumented immigrants.50 in response, in september 2009, president obama promised in a joint session of congress that his health care plan would do no such thing.51 foreshadowing the current heated state of political discourse, republican representative joe wilson from south carolina shouted over the president, “you lie.”52 what was most remarkable about this incident was not representative wilson’s breach of decorum, but the strength of the immigration-focused opposition to health reform. in effect, the aca’s opponents seemed to believe that denying immigrants access to care was even more important than ensuring that citizens had access to care.53 this vehemence, which anticipated president trump’s nationalist agenda, is also evident in other parts of the world. as in the u.s., immigrants in europe are blamed for diseases and derided as drains on publicly-funded health programs. to give but a few examples, supporters of brexit believed that immigration had caused a decline in the quality of health care services.54 in poland, former prime 46. personal responsibility and work opportunity reconciliation act of 1996, 110 stat. 2105. see infra text accompanying notes 60-70, for a further discussion. 47. see, e.g., hong pham v. starkowski, 16 a.3d 635, 637 (conn. 2011). 48. 2006 mass. acts ch. 58 (codified in various sections of mass. gen. laws (2008)). 49. mass. gen. laws ch. 65, § 31(a) (2009),). invalidated by finch v. commonwealth health ins. connector auth., 959 n.e.2d 970, 984 (mass. 2012). 50. julia preston, health care debate focuses on legal immigrants, n.y. times (nov. 3, 2009), https://www.nytimes.com/2009/11/04/health/policy/04immig.html [https://perma.cc/65p6btmk] (“the debate over health care for illegal immigrants continues to percolate in congress despite the obama administration’s efforts to put it to rest, with lawmakers in both houses also wrangling over how much coverage to provide for immigrants who have settled in the country legally.”). 51. rep. wilson shouts, ‘you lie’ to obama during speech, cnn (sept. 10, 2009), http://www.cnn.com/2009/politics/09/09/joe.wilson/ [https://perma.cc/u6nv-5nq9]. 52. id. 53. also relevant to the history is the collapse of a bipartisan immigration reform effort in congress in 2014. see, e.g., why immigration reform died in congress, nbc news (june 30, 2014), https://www.nbcnews.com/politics/first-read/why-immigration-reform-died-congressn145276 [https://perma.cc/7b79-c22b]. 54. public wrong on key facts around brexit and impact of eu membership, new study finds, king’s college london (oct. 28, 2018), https://www.kcl.ac.uk/sspp/policy-institute/news/ 218 indiana health law review [vol. 16:211 minister and current leader of the law and justice party, jaroslaw kaczyñski, has warned that migrants bring to europe “very dangerous diseases long absent from europe.”55 moreover, all european nations deny some classes of immigrants access to their national health insurance programs; and as migration has increased in the last several years, many european nations have cut back on programs that cover migrants.56 indeed, once we turn our eyes to the intersection of immigration and health, we can see that no western nation has truly universal health coverage.57 all exclude some noncitizen immigrants from some benefits. to understand why that is so, and to appreciate what happens when immigration and health policy meet, we need to look beyond today’s headlines, and not fool ourselves into thinking that today’s problems are simply the result of a single election. ii. undermining health policy it is easy to see how the laws and policies described above adversely affect the health and well-being of immigrants. what is less obvious, but no less important, is that these laws and policies add to the complexity, cost, and inefficiency of our health care system. in part, this is because as a nation we are deeply conflicted about immigrants’ place in our health care system. time after time, anti-immigrant sentiment has led to the enactment of laws that seek to limit access by both undocumented and authorized noncitizen immigrants to that system.58 but almost as often, the recognition that immigrants are members of our community, and that their health affects the health of citizens, has prompted the passage of other laws that create exceptions to the restrictive policies.59 the result is a hodgepodge of confusing and conflicting laws that make little sense from almost any policy perspective. consider prwora. it deemed certain categories of noncitizens, including undocumented immigrants and travelers, as “unqualified” for most federallyfunded benefits, including medicaid and the children’s health insurance program newsrecords/2018/public-wrong-on-key-facts-around-brexit-and-impact-of-eu-membership-newstudy-finds.aspx [https://perma.cc/hq3y-u93r]. 55. jan cienski, migrants carry ‘parasites and protozoa,’ warns polish opposition leader, politico (oct. 14, 2015, 6:21 pm), https://www.politico.eu/article/migrants-asylum-polandkaczynski-election/ [https://perma.cc/c9hv-t7qt]. 56. see, e.g., abby young-powell, austria plans to cut benefits for non-german speaking immigrants, telegraph (may 29, 2018, 5:48 pm), https://www.telegraph.co.uk/news/ 2018/05/29/austria-plans-cut-benefits-non-german-speaking-immigrants/ [https://perma.cc/d6kd5rc7]. 57. thailand, however, appears to have truly universal coverage. wudan yan, only one country offers universal health care to all migrants, nat’l pub. radio (mar. 31, 2016, 10:19 am), https://www.npr.org/sections/goatsandsoda/2016/03/31/469608931/only-one-country-offersuniversal-health-care-to-undocumented-migrants [https://perma.cc/g9de-rwpa]. 58. see supra text accompanying notes 45-53. 59. see infra text accompanying notes 63-75. 2019] the worst of health 219 (chip).60 it also established a five year bar during which time most classes of socalled “qualified immigrants,” not including refugees and certain other groups granted humanitarian treatment, are ineligible for such programs.61 whether those exclusions were good for health policy, i will leave for another day.62 for present purposes, what is interesting is that prwora’s restrictions are not all-encompassing. first, they do not apply to public health programs, such as vaccination clinics.63 thus, despite its aim of denying certain noncitizens access to federal benefits, congress recognized the importance of extending communicable disease prevention programs even to newcomers who were otherwise deemed unqualified for federal benefits. likewise, prwora does not bar undocumented immigrants from receiving so-called emergency medicaid,64 which provides reimbursement for hospitals that provide emergency medical treatment, as required by the emergency medical treatment and active labor act (emtala).65 this is in part because prwora kept in place emtala’s requirement that hospitals with emergency departments examine and stabilize patients who present with emergencies.66 congress was thus unwilling, despite its desire to deny immigrants public benefits, to see people with emergencies turned away to die on the streets. nor did congress want to force hospitals to bear all of the costs of treating immigrants who prwora left ineligible for federal health insurance programs. yet, the compromise that resulted from prwora’s efforts to limit immigrants’ access to benefits, while providing some access to emergency care, means that unqualified immigrants, as well as many qualified immigrants within prwora’s five year bar, are forced to receive much of their care in the most expensive setting, the emergency room.67 as a result, in some states, dialysis patients are forced to wait until their condition becomes critical in order to be dialyzed and cancer patients are left without access to ambulatory treatments and care.68 this is bad for their health and more expensive for the 60. 8 u.s.c. §§ 1611, 1621, 1641 (2012). 61. 8 u.s.c. § 1613 (2012). 62. i have criticized prwora’s exclusions elsewhere. see wendy e. parmet, who’s in?: immigrants and healthcare, in oxford handbook of u.s. health 1033, 1041-50 (i. glenn cohen, allison k. hoffman & william m. sage eds., 2017). 63. 8 u.s.c. §§ 1611(b)(1)(c), 1621(b)(3) (2012). 64. 8 u.s.c. §§ 1611(b)(1)(a), 1621(b)(1) (2012). (however, this exception excludes emergency organ transplants.). 65. 42 u.s.c. §§ 1395cc, 1395dd (2012). 66. 42 u.s.c. § 1395dd (2012). 67. illingworth & parmet, supra note 10, at 83-96. it should be noted, however, that many uninsured immigrants receive care in federally-funded community health centers. see steven p. wallace et al., community health centers play a critical role in caring for the remaining uninsured in the affordable care act era, ucla ctr. for health pol’y res: health pol’y brief (oct. 2016), http://healthpolicy.ucla.edu/publications/documents/pdf/2016/fqhc_pboct2016.pdf [https://perma.cc/t84s-2jlq].. 68. illingworth & parmet, supra note 10, at 83-96. 220 indiana health law review [vol. 16:211 government.69 how this makes sense from either a health care or health policy perspective is hard to see. congress’s ambivalence about noncitizens’ eligibility for publicly-supported health care is also evident in the fact that prwora allows states to expand or narrow immigrants’ eligibility to state-funded programs.70 subsequent federal laws have given states even greater leeway to expand coverage. for example, sec. 214 of the children’s health insurance program reauthorization act, permits states to cover lawfully present pregnant women and children, even if they are prwora-ineligible.71 as of 2018, thirty three states had elected to cover children and twenty five had chosen to cover pregnant women.72 the aca added to the intricacy by utilizing different criteria, “lawfully present,” to determine if immigrants were eligible for its own benefits.73 the aca also allowed lawfully present noncitizens, with income levels otherwise below those required of citizens, to buy insurance on the exchanges.74 this provision was an attempt to mitigate the fact that prwora bars many noncitizens with low incomes from enrolling in medicaid.75 these exclusions and exceptions to the exclusions underscore a simple point: immigration policies have added to the complexity and fragmentation of our already complicated and disparate health care system. indeed, while it is common to note the fragmentation that exists between medicare and the fifty plus medicaid programs, the overlay of immigration law adds to that division as many states run medicaid-like programs for immigrants who, due to prwora, are 69. id. 70. 8 u.s.c. § 1621(d) (2012) (state authority to provide for eligibility for unqualified noncitizens); 8 u.s.c. § 1622 (2012) (state authority to determine eligibility of qualified noncitizens). 71. 42 u.s.c.a. § 1396b(v)(4)(a) (2012). see also, children’s health insurance program reauthorization act of 2009, sec. 214, pub. l. no. 111-3, 123 stat. 9. 72. medicaid/chip coverage of lawfully-residing immigrant children and pregnant women, henry j. kaiser fam. found. (jan. 1, 2018), https://www.kff.org/health-reform/stateindicator/medicaid-chip-coverage-of-lawfully-residing-immigrant-children-and-pregnantwomen/?currenttimeframe=0&sortmodel=%7b%22colid%22:%22location%22,%22sort%22: %22asc%22%7d [https://perma.cc/97mq-3nhu]. 73. patient protection and affordable care act of 2010, 42 u.s.c. § 18032(f)(3) (2012). 74. 42 u.s.c. § 18071(e) (2012). 75. in enacting the aca, congress assumed that citizens with incomes under 100% of the federal poverty level (fpl) would be eligible for medicaid under the medicaid expansion. many lawfully present noncitizens would not be eligible because of prwora. hence the enactment of different eligibility levels was designed to permit low income noncitizens to access subsidized insurance on the exchanges in lieu of the medicaid that prwora denied them. illingworth & parmet, supra note 10, at 82-83. when the supreme court ruled that the medicaid expansion was voluntary for the states in nat’l fed. indep. bus. v. sebelius, 567 u.s. 519, 575-86 (2012), citizens in non-expansion states were left with less access to publicly-supported health insurance than lawfully present noncitizens. illingworth & parmet, supra note 10, at 82. 2019] the worst of health 221 ineligible for federal medicaid.76 yet, despite these state programs, and the many exceptions to the exclusions, significant coverage gaps remain. it therefore should not be surprising that noncitizen immigrants, both documented and undocumented, are less likely to have health insurance than the native-borne population.77 hence federal policies, including the aca, that have aimed to increase coverage, and reduce uncompensated care, have been limited in their reach in part due to immigrationfocused limitations. immigration law may undermine efforts to finance our health care system in other ways. despite the widely held belief that immigrants burden our health care system, research consistently shows that immigrants on average are younger, healthier, and use fewer health resources than native-born residents.78 a recent study by leah zallman and colleagues found that immigrants pay more in private insurance premiums than they receive in benefits,79 and a literature review by lila flavin and colleagues found that immigrants are a “net contributor[] to medicare’s trust fund.”80 yet, policies designed to restrict immigration and limit the ability of even lawfully-present immigrants from participating in insurance programs, limit their ability to participate in and fund these programs.81 in all of these cases, immigration law undercuts whatever policy objectives are otherwise apparent in health law. it also makes already complicated and murky areas of health law even more baroque. perhaps most importantly, by contradicting health policy objectives, and necessitating ever-more complex exceptions and work-arounds, the insertion of immigration law into health law creates inefficiencies and costs in implementation and compliance. 76. immigrant eligibility for health care programs in the united states, nat’l conf. of st. legislators (oct. 19, 2017), http://www.ncsl.org/research/immigration/immigrant-eligibilityfor-health-care-programs-in-the-united-states.aspx [https://perma.cc/l4nl-k9kl]. 77. jim p. stimpson & fernando a. wilson, medicaid expansion improved health insurance coverage for immigrants, but disparities persist, 37 health aff. 1656, 1660 (2018). 78. e.g., illingworth & parmet, supra note 10, at 89; see also eran shor, david roelfs & zoua m. vang, the “hispanic mortality paradox” revisited: meta-analysis and metaregression of life-course differentials in latin american and caribbean immigrants’ mortality, 186 soc. sci. & med. 20, 22 (2017) (reviewing literature on the healthy migrant effect, especially with regard to immigrants from latin america and the caribbean and noting that while immigrants overall enjoy a mortality advantage, immigrant children suffer from an immigrant mortality disadvantage). 79. leah zallman et al., immigrants pay more in private insurance premiums than they receive in benefits, 37 health aff. 1663, 1663 (2018). 80. lila flavin et al., medical expenditures on and by immigrant populations in the united states: a systematic review, 48 int’l j. health servs. 601, 616-17 (2018). 81. for a discussion of the public charge regulations, see infra text accompanying notes 10644. 222 indiana health law review [vol. 16:211 iii. harms to the public’s health the interjection of immigration policy into health law is also bad for the nation’s health. the danger, however, does not arise from the infections that immigrants allegedly bring to the country, as anti-immigrant critics frequently charge. indeed, for the most part, immigrants are healthier than native born citizens.82 and although they do have higher rates of tuberculosis, there is no evidence that they pose a significant risk of spreading that disease to the broader population.83 nor is there any reason to believe that they are more likely to transmit other infectious diseases. rather, the public health threats that arise at the intersection between immigration and health derive from policy decisions, including barriers to health coverage, stresses to the health care system, the exacerbation of negative social determinants, the perpetuation of stigma, and the displacement of evidence-based public health interventions with fear-based anti-immigrant policies. space permits only a brief discussion of each. as was noted previously, our health laws are riddled with provisions that exclude immigrants from publicly-financed health insurance programs. in part as a result of these exclusions, noncitizen immigrants, especially those who are undocumented, are far less likely to have insurance than native-born citizens.84 they are also less likely to have a regular source of care or to utilize preventive care.85 this means that although immigrants tend to be healthier than the nativeborn population,86 they may be more vulnerable to preventable or controllable diseases.87 pregnant women and children are especially at risk. studies show that many women without insurance delay or lack access to prenatal care, which can impact the long-term health of their children.88 children may also suffer when their parents have untreated or uncontrolled illnesses. around 18 million children in the u.s., most of whom are citizens, have at least one immigrant parent.89 these 82. see supra note 78. 83. see illingworth & parmet, supra note 10, at 62-73. 84. henry j. kaiser fam. found.., health coverage of immigrants 1 (2019), h t t p :/ / f i le s . k f f . o rg / a t t ach m en t /fac t -sh ee t -h ea lth -c overage-for -im m igran t s . [https://perma.cc/96ku-d3k9]. 85. frank otto, undocumented immigrants least likely to see a doctor, but still healthier than other populations, med. xpress (sept. 14, 2018), https://medicalxpress.com/news/2018-09undocumented-immigrants-doctor-healthier-populations.html [https://perma.cc/k8au-eywm]. 86. id. 87. see, e.g., cheryl bettigole, an uninsured immigrant delays needed care, 34 health aff. 2192, 2195 (2015). 88. proposed changes to “public charge” policies for immigrants: implications for health coverage, henry j. kaiser fam. found. (sept. 24, 2018), https://www.kff.org/disparitiespolicy/fact-sheet/proposed-changes-to-public-charge-policies-for-immigrants-implications-forhealth-coverage/ [https://perma.cc/8j9c-93sy]. 89. children in u.s. immigrant families, migration pol’y inst., https://www. 2019] the worst of health 223 children are vulnerable to policies that harm the health of their parents. public health is also threatened because health care institutions and health care workers bear the burdens of immigration laws’ impact on health care. safety net hospitals and community health centers are forced to bear more uncompensated costs when their patients are denied access to public programs or dis-enroll due to fear of the immigration consequences that may arise if they seek health care or enroll in publicly-funded insurance programs. safety-net providers also face extra burdens due to the added complexities that immigration policies have forged onto our health insurance system. in some cases, these extra costs and burdens may lead to fewer services or even hospital closings, to the detriment of all patients in a community.90 public health also suffers when health care workers are forced to worry about their own immigration problems. in 2016, immigrants comprised seventeen percent of the health care workforce.91 cutbacks in h1 visas and the termination of daca will affect many of these workers, including physicians and nurses.92 but less skilled workers—twenty-four percent of whom are immigrants—are especially vulnerable.93 for example, about one-quarter of home health aides are foreign born, and a third rely on public benefits.94 policies that increase their immigration risk due to their health or insurance status, or deny them access to health benefits, may make it harder for them to stay healthy and care for their patients. patients will also suffer, especially in the years to come, as an aging population increases the demand for immigrant workers who may not be there.95 in this sense, the policies that are imposed on immigrants rebound to the detriment of the health of citizens. policies at the intersection of immigration and health may also jeopardize migrationpolicy.org/programs/data-hub/charts/children-immigrant-families [https://perma.cc/tj68f743] (last updated 2017). 90. see illingworth & parmet, supra note 10, at 92; cindy mann, et al., medicaid payments at risk for hospitals under the public charge proposed rule 4 (nov. 2018), https://www.manatt.com/manatt/media/media/pdf/white%20papers/medicaid-payments-at-riskfor-hospitals.pdf [https://perma.cc/u42a-fpmw]. 91. szilvia altorjai & jeanne batalova, immigrant health-care workers in the united states, migration pol’y inst. (june 28, 2017), https://www.migrationpolicy.org/article/immigranthealth-care-workers-united-states [https://perma.cc/tm5e-2gb6]. 92. weinstein & saldana, supra note 7, at 1913-15; casey ross & max blau, us health care relies heavily on foreign workers. trump’s immigration ban is raising alarms (jan. 30, 2017), https://www.statnews.com/2017/01/30/trump-immigration-ban-health-workers/ [https://perma.cc/w2js-rs9c]. 93. altorjai & batalova, supra note 91. 94. wendy e. parmet & elisabeth ryan, new dangers for immigrants and the health care system, health aff. blog (apr. 20, 2018), https://www.healthaffairs.org/do/10.1377/ hblog20180419.892713/full/ [https://perma.cc/qcb9-jxax]. 95. see e. tammy kim, americans will struggle to grow old at home, bloomberg businessweek (feb. 9, 2018), https://www.bloomberg.com/news/features/2018-02-09/americanswill-struggle-to-grow-old-at-home. 224 indiana health law review [vol. 16:211 public health by increasing the stress on immigrants and their families. although hospitals are supposedly sensitive institutions, in which ice will not generally carry out enforcement proceedings,96 news reports about immigrants being detained on the way to seeking care, and the broader crackdown on immigrants, has helped to create a climate of fear. even before the publication of the proposed public charge rule, clinicians reported that immigrant patients were canceling or skipping their appointments97 and that children were experiencing increased signs of a wide range of stress-related problems, including depression, anxiety, headaches, stomachaches, and problems sleeping and eating.98 many of the children suffering these consequences are citizens.99 immigration policies also harm public health by increasing the stigma surrounding different diseases. for example, consider the tension that existed for many years between policies that sought to encourage hiv testing and the ban on immigration by individuals who were hiv positive.100 while health officials sought to reduce stigma as a way of encouraging hiv testing and controlling the epidemic, immigration-focused policies reinforced stigma by penalizing people for their hiv status. indeed, the hiv immigration ban even led to a long-running boycott of the u.s. by the international aids conference, and kept many hiv researchers from traveling to and working in the u.s.101 likewise, the ina’s bar of entry to drug users and addicts102 reinforces the stigma associated with substance use disorders, potentially undermining efforts to destigmatize the problem and increase people’s willingness to seek treatment.103 the insertion of immigration into public health law may also undermine public health efforts in a more subtle fashion. as long as the public believes that 96. faq on sensitive locations and courthouse arrests, u.s. immigration & customs enforcement, https://www.ice.gov/ero/enforcement/sensitive-loc [https://perma.cc/v53s-lb82]. 97. the children’s partnership, california children in immigrant families: the health provider perspective, (2018), https://www.childrenspartnership.org/wpcontent/uploads/2018/03/provider-survey-inforgraphic-.pdf [https://perma.cc/k8w4-3rv6]. 98. samantha artiga, & petry ubri, living in an immigrant family in america: how fear and toxic stress are affecting daily life, well-being, & health, henry j. kaiser fam. found. (dec. 13, 2017), https://www.kff.org/disparities-policy/issue-brief/living-in-an-immigrant-familyin -america-how-fear-and-toxic-stress-are-affect ing-daily-life-well-being-health / [https://perma.cc/j7tf-wu63]. 99. id. 100. see supra text accompanying notes 44-45. 101. brett norman, after 22 years, aids meeting in d.c., politico (july 22, 2012, 10:13 pm), https://www.politico.com/story/2012/07/after-22-years-aids-conference-comes-to-dc-078829 [https://perma.cc/pmp6-5dlr] (reporting that the international aids conference was returning to the u.s. after a twenty-two year boycott following the ban on visas to people who were hiv positive). 102. 8 u.s.c. § 1182(a)(1)(a)(iv) (2012). 103. on the impact of stigma on substance use disorders, see, e.g., lawrence h. yang et al., stigma and substance use disorders: an international phenomenon, 30 current opinion psychiatry 378, 378 (2017). 2019] the worst of health 225 infectious diseases and pandemics are caused by immigrants, it will continue to demand travel and immigration bans, in the mistaken belief that infectious threats can be kept out of the country by keeping certain people out. this can lead to calls to build walls, rather than support more effective, evidence-based policies. this was evident during the 2014 ebola epidemic, when many politicians and pundits demanded the imposition of a travel ban, even though health experts cautioned that a ban would undermine efforts to fight the outbreak at its source in west africa.104 likewise, in 2018, anti-immigrant critics charged that a caravan of migrants heading toward the u.s. from central america had to be stopped because they were bringing smallpox, leprosy, and other dangerous diseases into the country.105 such false claims can mislead americans into thinking that public health can be protected by keeping “them” out, rather than by vaccinating their own children. more generally, by locating health problems in “the other,” xenophobia misdirects public health policy away from evidence-based interventions that address the complex social determinants of both communicable and non-communicable diseases. iv. the public charge regulations the potential of anti-immigration policies to harm both the health care system and public health is especially evident in the trump administration’s proposed public charge regulations. as noted above, the ina has long deemed immigrants who are “likely to become a public charge” inadmissible to the united states.106 in the nineteenth and early twentieth centuries, this provision was widely used to keep out individuals who were considered undesirable on the basis of racial or class grounds.107 for example, in the 1930s, the public charge provision was used to turn away jewish refugees from the holocaust.108 currently, the provision does not apply to refugees, asylees, survivors of 104. tom frieden, cdc director: why i don’t support a travel ban to combat ebola, ctrs. disease control & prevention: our global voices (oct. 13, 2014), https://blogs.cdc.gov/ global/2014/10/13/cdc-director-why-i-don’t-support-a-travel-ban-to-combat-ebola-outbreak/ [https://perma.cc/6cum-ulk3]. 105. see julia belluz, fox news says the migrant caravan will bring disease outbreaks. that’s xenophobic nonsense, vox (nov. 1, 2018, 12:06 pm), https://www.vox.com/science-andhealth/2018/11/1/18048332/migrant-caravan-fox-news-disease-smallpox-outbreaks-vaccinesxenophobia. [https://perma.cc/2vhv-94aq]. the claim about smallpox was especially absurd, given that smallpox has been eradicated in nature. id. 106. immigration and nationality act § 212(a)(4), 8 u.s.c. § 1182(a)(4) (2012). 107. see lisa sun-hee park, criminalizing immigrant mothers: public charge, health care, and welfare reform, 37 int’l j. soc. fam. 27, 43 (2011). 108. barbara l. bailin, the influence of anti-semitism on united states immigration policy with respect to german jews during 1933-1939 (may 10, 2011) (unpublished m.a. thesis, city university of new york) (on file with city university of new york), https://academicworks. cuny.edu/cgi/viewcontent.cgi?article=1261&context=cc_etds_theses [https://perma.cc/cbd69dqa]. 226 indiana health law review [vol. 16:211 domestic violence and certain other exempt classes of immigrants.109 however, most immigrants who seek a visa or adjustment of status, usually to receive legal permanent residency status, have to prove they are not likely to become a public charge.110 in making its public charge determination, the ina requires the united states citizenship and immigration service (“uscis”) to consider an immigrant’s age, health, family status, resources and financial status, and education and skills.111 since 1997, uscis has not considered an immigrant’s use of non-cash benefits, including medicaid and chip, in making the public charge determination, except when the benefits were used for long-term care.112 the trump administration is seeking to change that, dramatically expanding the meaning and impact of the public charge determination. under proposed regulations that were published in the federal registrar on october 10, 2018, the term “public charge,” would be defined to include immigrants who use more than fifteen percent of the federal poverty level of cash benefits, as well as specified non-cash benefits, including medicaid, and medicare part d subsidies, as well as supplemental nutrition assistance program (“snap”) or federal housing subsidies113 for more than twelve months within a thirty-six month period.114 (although the regulations did not include chip in the definition of public charge, the department of homeland security (“dhs”) asked for comments about whether chip should be added.)115 thus an immigrant could be found “likely to become a public charge,” and hence inadmissible, if uscis found that he or she was likely to use medicaid or medicare part d subsidies for twelve months out of thirty-six months subsequent to the adjustment of status. however, the regulations do not specify that the forward-looking determination 109. 8 u.s.c. §§ 1157(c)(3), 1182(a)(4)(e) (2012). 110. 8 u.s.c. § 1182(a)(4) (2012); see em puhl, et al., immigration legal res. ctr., an overview of public charge 1 (2018), https://www.ilrc.org/sites/default/files/resources/ overview_of_public_charge-20181214.pdf [https://perma.cc/fs7v-qfpw] (stating that deportation on public charge grounds is possible, but only in very limited circumstances). 111. 8 u.s.c. § 1182(a)(4)(b)(i) (2012). 112. inadmissibility and deportability on public charge grounds, 64 fed. reg. 28,676-677 (proposed may 26, 1999) (to be codified at 8 c.f.r. pts. 212, 237). 113. see inadmissibility on public charge grounds, 83 fed. reg. 51,114, 51,114 (proposed oct. 10, 2018) (to be codified at 8 c.f.r. pts. 103, 212-14, 245, 248); see also artiga et al., supra note 9 (discussing the public charge proposal and its impact on immigrants). some medicaid benefits, including benefits for foreign-born children of u.s. citizens, and benefits provided under the individuals with disabilities education act were exempted. see inadmissibility on public charge grounds, 83 fed. reg. at 51,170. 114. see inadmissibility on public charge grounds, 83 fed. reg. at 51,290 (discussing that under the proposed regulations, an immigrant who uses two or more of the listed benefits would be considered a public charge for using the benefits for fewer months, and in addition, that the use of the benefits for fewer months would trigger a public charge determination if the immigrant also received cash benefits). 115. id. at 51,173. 2019] the worst of health 227 is to be confined to the thirty-six months immediately following the adjustment of status, thus opening the possibility that an immigrant could be found likely to be a public charge if uscis determined that the immigrant would use the listed benefits at any time in the future.116 given the fact that as much as thirty percent of u.s. citizens receive some of the listed benefits,117 a very large number of immigrants will be vulnerable to the determination.118 the proposed regulations stress that the public determination must be made using the “totality of circumstances.”119 however, in determining whether an immigrant is likely to be a public charge in the future, the regulations would require uscis to treat the past use of the listed cash or non-cash benefits in the thirty-six months prior to application as a heavily weighted negative factor.120 other negative factors include an income of less than 125% of the federal poverty level, age under eighteen or over sixty-two, or having a medical condition that may lead to expensive treatment while lacking private health insurance.121 according to dhs, these regulations are necessary to enforce immigration law’s goal of admitting only those who are “self-sufficient.”122 this goal, articulated in prwora,123 conflicts with public health’s recognition that disease and disability are, for the most part, socially determined; and that no individual can be truly self-sufficient when it comes to health.124 moreover, by labeling immigrants who use health benefits as “public charges,” the regulations would effectively stigmatize and demean the over 66,000,000 individuals who are 116. id. at 51,290. 117. id. at 51,185. 118. kate woomer-deters, the proposed ‘public charge’ rule: an attack on immigrant and working families 1 (n.c. justice ctr., 2018), https://www.ncjustice.org/wpcontent/uploads/2018/11/irrp_public-charge-factsheet-english-october-2018.pdf [https://perma.cc/kc6n-vkxv]. 119. inadmissibility on public charge grounds, 83 fed. reg. at 51,291. many immigrants and mixed status families will also be adversely affected by other provisions in the proposal rule, including the proposal to treat income below 125% of the federal poverty level. id. at 51,123. randy capps et al., gauging the impact of dhs’ proposed public-charge rule on u.s. immigration 1 (migration policy inst., 2018). the current discussion, however, focuses on the proposed regulation’s treatment of non-cash benefits that relate to health. 120. capps et al., supra note 119, at 6, 14. 121. inadmissibility on public charge grounds, 83 fed. reg. at 51,290. 122. id. at 51,118 (“the primary benefit of the proposed rule would be to help ensure that aliens who apply for admission to the united states, seek extension of stay or change of status, or apply for adjustment of status are self-sufficient”). 123. 8 u.s.c. § 1601 (2012). 124. see samantha artiga & elizabeth hinton, beyond health care: the role of social determinants in promoting health and health equity, henry j. kaiser fam. found. (may 10, 2018), https://www.kff.org/disparities-policy/issue-brief/beyond-health-care-the-role-of-socialdeterminants-in-promoting-health-and-health-equity/ [https://perma.cc/k6tn-r8k9]. see also illingworth & parmet, supra note 10, at 115-32 (arguing that health is a public good). 228 indiana health law review [vol. 16:211 enrolled in medicaid,125 and the over 13,000,000 americans who receive medicare d subsidies.126 the regulations would also exacerbate the stigma associated with disability by requiring uscis to consider disability in the public charge determination.127 although dhs promises that disability will not be the “sole factor” in that determination,128 by treating disability as a negative factor, in circumstances that go far beyond the commands of the ina,129 dhs is communicating the message that individuals with a disability are burdensome, public charges. this is a message that will undoubtedly rebound upon citizens with disabilities. it is also a message that is contrary to the one congress sought to deliver in enacting the rehabilitation act of 1973 and the americans with disabilities act.130 the regulations, like other immigrant-focused health policies, will also add needless complexity to our already complicated health care system. under the proposal, the use of federal medicaid, but not chip or state public health benefits, would constitute a heavily negative factor in the assessment of whether an immigrant was likely to be a public charge in the future.131 however, most 125. ctrs. for medicare & medicaid servs., november 2018 medicaid & chip enrollment data highlights, medicare.gov, https://www.medicaid.gov/medicaid/program-information/ medicaid-and-chip-enrollment-data/report-highlights/index.html [https://perma.cc/y2bu-jqel]. 126. an overview of the medicare part d prescription benefit, henry j. kaiser fam. found. (oct. 12, 2018), https://www.kff.org/medicare/fact-sheet/an-overview-of-the-medicarepart-d-prescription-drug-benefit/ [https://perma.cc/k9z9-yb57]. 127. inadmissibility on public charge grounds, 83 fed. reg. at 51,183. 128. id. 129. the ina explicitly lists certain health and disability-related criteria. in addition to barring entry by individuals with a “communicable disease of public health significance,” the statute bars admission by individuals who are not vaccinated with specified vaccines, or are determined “to have a physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others,” or “to have had a physical or mental disorder and a history of behavior associated with the disorder, which behavior has posed a threat to the property, safety or welfare of the alien or others and which behavior is likely to recur or to lead to other harmful behavior,” or are “determined. . .to be a drug user or addict..” 8 u.s.c. § 1182(a)(1)(a) (2013). notably, the act does not list disability or other serious medical conditions as a ground for inadmissibility; rather, the disability and health-related bars are limited to situations in which the immigrant would pose a risk to the health or well-being of others. see, e.g., 8 c.f.r. § 212.4 (2013); 8 c.f.r. § 212.7 (2016). in contrast, by treating health conditions and disability as negative factors, even when they pose no risk to others, the proposed regulations would depart from those understandings, as well as from congress’s intention in limiting the reach of the health and disability-related bars. 130. see 42 u.s.c. § 12101(a) (2013) (stating congress’s findings in enacting the americans with disabilities act); sch. bd. of nassau cty. v. arline, 480 u.s. 273, 279 (1987) (discussing congress’s intent to move the nation past “archaic attitudes and laws” regarding disability in enacting the rehabilitation act of 1973). 131. see supra text accompanying note 115. 2019] the worst of health 229 children who receive chip are covered through their state’s medicaid program.132 by treating all uses of “medicaid” by immigrants as problematic, the public charge regulations may deter immigrants from using these even those programs that are otherwise excluded from the regulations. this may lead states to decide to disaggregate programs to reduce the chill. doing so, of course, will add to state health care costs. more importantly, the regulations will likely have a significant adverse impact on public health. most directly, the regulations will increase the number of uninsured patients. by treating the past use of public health programs as a heavily weighted negative factor, and defining someone who uses health benefits as a public charge, the regulations are expected to deter many immigrants, and citizens in mixed-status families, from accessing health benefits to which they are legally entitled.133 the henry j. kaiser family foundation, for example, estimates that the regulations will cause 2.1 to 4.9 million enrollees to leave medicaid and chip.134 the california health care foundation estimates that 700,000 to 1.7 million children who are in need of medical attention will disenroll from medicaid or chip.135 importantly, even many immigrants and citizens who are not subject to the public charge determination are expected to dis-enroll from medicaid and chip, as past experience with laws limiting coverage for immigrants suggest that the chill can extend far beyond those who are directly affected.136 this seems especially likely given the current climate of fear. as noted above, immigrants’ loss of health coverage can have substantial negative impacts on health care providers.137 safety-net providers in communities with large immigrant populations will likely see significant increases in uncompensated care, adding financial strains to already burdened safety-net providers.138 according to a report by manatt health, hospitals are at risk of losing $17 billion a year.139 at the same time, hospitals will face increases in uncompensated care, as immigrants are forced to rely increasingly on emergency care.140 ironically, the regulations may exacerbate this problem because the use of medicaid for emergency medical conditions will not count in the public charge 132. mann et al., supra note 90, at 4. 133. id. 134. artiga et al., supra note 9. although the proposal does include chip in the definition of public charge, more than half of the children whose health coverage is funded by chip are enrolled in state medicaid programs, and many families do not know whether their coverage is through chip or medicaid. see mann et al., supra note 90, at 7. 135. leah zallman & karen finnegan, changing public charge immigration rules: the potential impact on children who need care, cal. health care found. (oct. 23, 2018), h t t ps :/ /w w w .ch cf .o rg /pu blicat ion /changing-public-charge-im m igra t ion -ru les / [https://perma.cc/g3dw-uj5k]. 136. mann et al., supra note 90, at 11. 137. see supra text accompanying notes 90-94. 138. mann et al., supra note 90, at 4. 139. id. at 5 (based on 2016 revenues). 140. id. at 4. 230 indiana health law review [vol. 16:211 determination.141 thus immigrants will have a strong incentive to avoid receiving medicaid coverage unless and until a condition becomes emergent. this incentive will likely be strengthened by the fact the regulations will also treat the presence of medical conditions in the absence of private insurance as a negative factor.142 as a result, immigrants who are uninsured, or who receive state insurance benefits, may feel that it is unwise to see physicians or have diagnostic tests, lest they be found to have a medical condition that might disqualify them from receiving permanent residency status. in addition, by treating other non-cash benefits, including snap and housing support, as a public charge, the regulations will reduce immigrants’ use of nutritional and housing programs that can be important positive social determinants of health.143 the health impacts of these regulations, as well as other immigration laws that relate to health, will not be limited to noncitizens. eighteen million american citizen children have at least one immigrant parent.144 these children will inevitably be affected, not only because of the chilling effect that may lead parents to dis-enroll citizen children from health programs, but because increased parental coverage is associated with increases in pediatric primary care in lowincome families.145 moreover, children will feel the effects if their parents lose access to health coverage and forgo medical care. american citizen children will also feel the impact if their parents forgo snap or housing subsidies. food and housing, after all, affect everyone in a household. in addition, the health of households affects the health of their communities. when children can’t go to school because they or their parents are sick, when workers can’t be productive because they’re forgoing basic health care, communities as a whole suffer. thus, in the name of promoting self-sufficiency among immigrants, the regulations will 141. inadmissibility on public charge grounds, 83 fed. reg. 51,114, 51,290 (proposed oct. 10, 2018) (to be codified at 8 c.f.r. pts. 103, 212-14, 245, 248). 142. although the regulations do not view receipt of aca subsidies as rendering someone a public charge, the provisions in the regulations relating to medical conditions seem broader, and treat the presence of a medical condition in the absence of private insurance, as a highly weighted negative factor in the public charge determination. inadmissibility on public charge grounds, 83 fed. reg. at 51,182. this would seem to suggest that an immigrant who receives aca premium tax credits, chip, or state benefits, and is diagnosed with a pre-existing condition, might as a result be found likely be found to be a public charge. if so, the regulations will disincentivize immigrants from enrolling even in those programs that are not included in the definition of public charge. 143. on snap as a positive social determinant of health, see nancy e. adler et al., addressing social determinants of health and health inequalities, 316 j. am. med. ass’n 1641, 1641 (2016). on the relationship between housing affordability and health, see megan sandel & matthew desmond, investing in housing for health improves both mission and margin, 318 j. am. med. ass’n 2291, 2291 (2017); b. cameron webb & dayna bowen matthew, housing: a case for the medicalization of poverty, 46 j.l. med. & ethics 588, 591, 593 (2018). 144. children in u.s. immigrant families, supra note 89. 145. maya venkataramani et al., spillover effect of adult medicaid expansion on children’s use of preventive services, 140 pediatrics 1, 6 (2017), http://pediatrics.aappublications.org/ content/pediatrics/140/6/e20170953.full.pdf [https://perma.cc/6mxp-p7gm]. 2019] the worst of health 231 threaten the health of all. v. solidarity for health what can we learn about health law from its relationship with immigration policy? most obviously, we see from the exclusions and the insistence on selfsufficiency the strong strains of individualism and individual responsibility that run through american health policy, and have helped to mark other battles over medicaid, medicare, and even the aca. ambivalent about the idea that health care is right, reluctant to see diseases as socially determined, we often feel the need to draw lines, limit eligibility, and blame people for their own illnesses. in this task, immigration policy, especially exclusionist immigration policy, presents a handy tool. immigrants are easy scapegoats. if lines have to be drawn, they can easily be drawn around noncitizens who cannot vote and are often members of racial or ethnic minorities. and if citizens can bar and blame noncitizens, they can feel confident that the health care system is only for those who are deserving. yet, the story is more nuanced. immigration policy adds to the complexity of and contradictions within our health care system precisely because many exclusions are partially mitigated by exceptions; and punitive measures are often counter-balanced by more inclusive, and supportive policies. these exceptions to the exclusions that add to health law’s complexity suggest that individualism, exclusion, and xenophobia are not the only, or even the dominant chords at the intersection between health and immigration. there are also strong themes of inclusion, compassion, and even solidarity.146 this, i think, gets us to the gist of the tensions at the juncture between immigration and health law. perhaps more than any other field, health law deals with human vulnerability: our illnesses, our weaknesses, and ultimately our mortality. as patients, we literally and metaphorically expose ourselves to others; we become intimate and vulnerable. to whom shall we expose ourselves? to whose vulnerabilities shall we respond? as ruud ter meulen explains, the concept of solidarity refers to a willingness to act for others out of a sense of identification with them.147 solidarity underpins a willingness to carry costs for others that goes beyond simple, short term self-interest.148 i care for the health of others not because i believe that doing so will benefit me (though at times it will), or even because doing so is just (though it may well be). i do so because i recognize my own vulnerabilities in their predicament. solidarity is often said to underpin the social welfare state, including national 146. see supra notes 63-76 and accompanying text; see also illingworth & parmet, supra note 10, at 190-97 (describing the u.s. response to the ebola outbreak in west africa as evincing solidarity). 147. ruud ter meulen, solidarity and justice in health and social care 4 (2017). 148. barbara prainsack & alena buyx, solidarity in contemporary bioethics–towards a new approach, 26 bioethics 343, 347 (2012). 232 indiana health law review [vol. 16:211 health care systems.149 we see it in the united kingdom’s national health service, and in the canada health act. but it is also present, albeit to a lesser extent, in medicare, medicaid, and the aca. solidarity, however, can be and often is exclusionary. it may also adhere more easily to those who appear similar, or who share a demographic identity. relatedly, some have theorized that the regulation of immigration and the maintenance of borders may serve to abet the formation solidarity,150 while inclusion and heterogeneity may weaken the solidarity that is necessary for the maintenance of strong social welfare programs.151 perhaps for this reason, as noted above, even the most robust national health programs exclude certain newcomers. moreover, the most generous social welfare states tend to be in relatively homogenous countries; and social welfare programs in these states have faced new challenges as globalization and migration have threatened national homogeneity.152 solidarity, however, need not rely on either borders or demographic identities. it can also cohere around mutual goals and experiences, common causes, shared vulnerabilities and caregiving.153 as iris young explains, solidarity can arise among people who “dwell together.”154 bruce jennings adds that solidarity can develop when people share relationships of “structural interdependence.”155 and no realm creates more opportunities for shared experiences and interdependencies across immigration statuses than health. immigrant caregivers take care of citizen patients in their most vulnerable hours, while citizen providers care for their immigrant patients in their times of need.156 immigrant and native-born share overcrowded emergency departments, breathe the same polluted air, and suffer from the same disease outbreaks. they experience the same social determinants, and the health of each affects the health of the other. this commonality of experience and interdependency with respect to health creates shared interests and mutual vulnerabilities, opening the door to 149. see illingworth & parmet, supra note 10, at 174; see also lisa eckenwiler et al., global solidarity, migration and global health inequity, 26 bioethics 382, 383 (2012). 150. see illingworth & parmet, supra note 10, at 175-76. hiroshi motomura writes that a “persuasive” argument for immigration laws and borders is that they can reinforce “civic solidarity.” hiroshi motomura, who belongs?: immigration outside the law and the idea of americans in waiting, 2 u.c. irvine l. rev 359, 365 (2012). 151. see, e.g., paul collier, exodus: how migration is changing our world 85 (2013). 152. see david abraham, recognizing the problem of solidarity: immigration in the postwelfare state, 55 wayne l. rev. 1641, 1645 (2009). 153. prainsack & buyx, supra note 148, at 346-48. 154. iris marion young, inclusion and democracy 197 (2000). for a further discussion, see illingworth & parmet, supra note 10, at 182-89. 155. bruce jennings, solidarity and care as relational practices, 32 bioethics 553, 554 (2018). 156. for a discussion of how the inclusion of migrant workers in the health care workforce create opportunities for solidarity, see eckenwiler et al., supra note 149, at 385-87. 2019] the worst of health 233 a solidarity that need not be defined by demographic identities or citizenship status.157 despite the current climate of ethno-nationalism, we see signs of this occurring, not only in the exceptions to the exclusionary policies, and the policies that provide for the health of newcomers, but also in the demonstrations by doctors against the travel ban,158 the statements of physician groups protesting family separation,159 and the innumerable non-governmental organizations that are fighting for better health for all members of their community.160 thus, solidarity can and has been forming around health. from there it can potentially extend to other domains, challenging structures of social injustice. bruce jennings explains, “solidarity begins with the recognition of reciprocal and symbiotic interdependence among members of a moral community and then intervenes in– interrupts–an ongoing community when it is unjustly exclusionary and refuses to recognize the moral standing of some within it.”161 or, to put it another way, the solidarity that forms in health can force us to see and then demand a wider recognition of each other’s humanity. perhaps this is why the battles over health and immigration are so contentious. the laws and policies that lie at the intersection of immigration and health are not simply about the health of immigrants. rather, the barriers that are imposed on the health of immigrants are structures designed to thwart the formation of solidarity and the rejection of intolerance. and the exceptions to the exclusions and the resistance to those barriers are reminders of why we have health care systems and laws to support them: because we are human. 157. illingworth & parmet, supra note 10, at 177-89. 158. felice j. freyer, in white coats, doctors join copley protest, boston globe (jan. 29, 2017), https://www.bostonglobe.com/metro/2017/01/29/white-coats-doctors-join-copleyprotest/h6qubk5rfjpse6s2xlglek/story.html [https://perma.cc/bj42-qhpa]. 159. biggest u.s. doctors group condemns family separation policy, politico (june 20, 2018, 12:07 pm), https://www.politico.com/story/2018/06/20/american-medical-associationfamily-separation-policy-655677 [https://perma.cc/9peg-galh]. 160. id., see, e.g., illingworth & parmet, supra note 10, at 182. 161. jennings, supra note 155, at 557. just caring: do the indolent, the inebriated and the irresponsible deserve equal access to needed health care just caring: do the indolent, the inebriated and the irresponsible deserve equal access to needed health care? leonard m. fleck* i. introduction ............................. ..... 553 ii. the unbearable arbitrariness of judgments of personal responsibility in health care ............... 558 iii. political liberalism, value pluralism, and personal responsibility for health ............ 570 iv. physician integrity and personal responsibility for health ............................. ....... 576 v. personal responsibility for health and health care justice. .............................. ..... 579 i. introduction in 2012 we in the united states spent about $2.8 trillion on health care, or about 17.8% of our gross domestic product ("gdp").' that can be compared to 1960 when we spent only $27 billion on health care (5.0% of gdp) and to projections for 2022 of $5.0 trillion (20% of expected gdp).2 most of that represents spending on the private side of the economy.3 more troubling, politically speaking, are professor of philosophy and medical ethics, center for ethics and humanities in life sciences, college of human medicine, michigan state university; ph.d., st. louis university. 1 gigi cuckler et. al., national health expenditure projections, 2012-22: slow growth until coverage expands and economy improves, 32 health aff. 1820, 1820, 1829 (2013). 2 id. for the 1960 figures, as well as a number of intervening years, see national health expenditures; aggregate and per capita amounts, annual percent change and percent distribution: selected calendar years 1960-2012, http://www.cms.gov/research-statistics-data-and-systems/statisticstrends-and-reports/nationalhealthexpenddatadownloads/tables.pdf, archived at http://perma.cc/4e9e-spae. 3 id. at 1829. indiana health law review medicare and medicaid cost projections. medicare spending in 2012 was about $580 billion, with projections to 2022 of $1.12 trillion, and ten-year projections (2013-2022) of $8.5 trillion.4 medicaid spending in 2012 was $417 billion, with projections to 2022 of $839 billion, and ten-year projections (2013-2022) of $6.35 trillion.5 given these statistics, it is easily understandable why taxpayers and insurance premium payers are demanding that somebody do something to control escalating health care costs. while there are multiple reasons why health care costs have increased much faster than the core rate of inflation in the economy, most health policy analysts would see emerging medical technologies as the primary driver of these cost increases.6 what this suggests is that someone ought to do something to control the cost and utilization of these emerging medical technologies. however, this proposal will quickly elicit public outrage about health care rationing.7 that outrage might be expressed this way: 4 id. at 1827. 5 id. 6 daniel callahan deserves credit for early on identifying the connection between emerging medical technologies and what we would regard as health care "needs" (in the morally valenced sense of that term). his point is that there is no need for bypass surgery until bypass surgery has been invented. the same is true for every other advance in medicine over the past forty years. if medical progress were limitless, then the expansion of medical need and the costs of meeting those needs would be limitless as well. callahan writes, "more fundamentally, however, it is medical progress itself that has rendered the enterprise of defining individual curative need as impossible, and thus with it notions of finding some identifiable baseline of healthcare to be provided to all." daniel callahan, what kind of life: the limits of medical progress 47 (1990); see also daniel callahan, taming the beloved beast: how medical technology costs are destroying our health care system chs. 2-3 (2009). 7 the national health service ("nhs") in the united kingdom relies upon the national institute for clinical excellence ("nice") to judge whether or not novel pharmaceuticals, such as trastuzumab for breast cancer, are truly cost-effective, i.e., yield enough medical good at a reasonable enough cost that they ought to covered by the nhs for all patients in the relevant clinical circumstances. nice did approve trastuzumab as a first-line cancer treatment for non-metastatic breast cancer but denied funding once cancer has become metastatic. this elicited public outcries of "rationing" as the following article 554 vol. 11:2 just caring "how can a just or compassionate society deny lifeprolonging cancer drugs or an artificial heart to desperate patients simply because of the cost of these interventions?" nevertheless, these same outraged citizens want more effective control of health care costs. at this point another set of statistics is called forth. about 35% of cancers are avoidable through behavioral change. most of the cancers alluded to in that statistic are related to smoking.8 another statistic is that 94% of diabetes is avoidable through behavioral change.9 this is related to various unhealthy dietary choices, many of which are linked to what is referred to as the "obesity epidemic." that, in turn, is linked to a substantial portion of heart disease.10 for many individuals these statistics will suggest a cost-saving alternative to indiscriminate rationing. namely, it is more to ration more selectively. specifically, these individuals will contend that individuals whose compromised health is related to "irresponsible" health choices ought to be denied needed care, at least at social demonstrates. rebecca smith, breast cancer sufferers denied two drugs on nhs, telegraph (feb. 14, 2012, 7:00 am), http://www.telegraph.co.uk/health/healthnews/9079213/breast-cancersufferers-denied-two-drugs-on-nhs.html, archived at http://perma.cc/6d7a-bw7z. 8 see ahmedin jemal et. al., global cancer statistics, 61 ca: cancer j. clinicians 69 (2011), available at http://onlinelibrary.wiley.com/doi/10.3322/caac.20107/pdf, archived at http://perma.cc/qt74-rsw6. 9 see diabetes statistics: data from the 2011 national diabetes fact sheet, am. diabetes ass'n, http://www.diabetes.org/diabetesbasics/statistics (last updated feb. 12, 2014), archived at http://perma.cclrv4f-76hf. at present about 26 million americans have diabetes, and another seventy-nine million are pre-diabetic. id. 10 see generally james r. hebert et. al., scientific decision making, policy decisions, and the obesity pandemic, 88 mayo clinic proc. 593 (2013) ("rising and epidemic rates of obesity in many parts of the world are leading to increased suffering and economic stress from diverting health care resources to treating a variety of serious, but preventable, chronic diseases etiologically linked to obesity, particularly type 2 diabetes mellitus and cardiovascular diseases. despite decades of research into the causes of the obesity pandemic, we seem to be no nearer to a solution now than when the rise in body weights was first chronicled decades ago."). 2014 555 indiana health law review expense, or else ought to pay more for their health care, either in the form of higher insurance premiums or substantial co-pays and deductibles for those interventions related to health needs linked to "irresponsible" health behavior." critics of "irresponsible" health behavior will sometimes make the moral argument that it is unfair that individuals who have taken very good care of their health, i.e., been responsible, should have to pay for the excessive health needs of those who have been irresponsible with their health. an analogy often invoked in this regard is automobile insurance.12 drivers who have been very responsible in their driving habits, i.e., no accidents and very few moving citations, typically pay a lot less for their automobile insurance compared to irresponsible drivers who have been involved in multiple accidents or are frequently cited for traffic violations. if we see such discounts as fair and reasonable, the argument goes, we ought to see as equally fair and reasonable expecting those with greater health needs due to "irresponsible" health choices to pay more for their health care or else be denied that care. further, it is morally troubling (for political liberals, not 11 i have placed the word 'irresponsible' in scare quotes because, as i will argue, it is used much too promiscuously and arbitrarily in ethical and policy discussions of personal responsibility for health to achieve rhetorical advantage. in an earlier essay i, and two of my colleagues, critically examined the use of the language of "irresponsibility" in connection with choices made by parents to avoid using alternate reproductive options for purposes of preventing the birth of a child with a serious genetic disorder. see judith andre et al., on being genetically "irresponsible" 10 kennedy inst. ethics j. 129 (2000). 12 the ceo of the safeway food store chain is one prominent proponent of this view with regard to personal responsibility for health. he wrote in a wall street journal opinion piece: "as much as we would like to take credit for being a health-care innovator, safeway has done nothing more than borrow from the well-tested automobile insurance model. for decades, driving behavior has been correlated with accident risk and has therefore translated into premium differences among drivers. stated somewhat differently, the auto-insurance industry has long recognized the role of personal responsibility." steven a. burd, how safe way is cutting health -care costs, wall st. j. (june 12, 2009, 12:01 am), http://online.wsj.com/news/articles/sb12447680402630860 3 , archived at http://perma.cc/s7mb-w5vs. 556 vol. 11:2 just caring just political conservatives) that individuals with very costly health care needs related to diseases over which they could have no control whatsoever, such as cystic fibrosis or duchenne's muscular dystrophy or schizophrenia, should be denied affordable health insurance, and, hence, secure access to needed and effective health care, while those whose medical problems are related to "irresponsible" health choices should have all their health care costs covered because they happen to work for large employers with generous health benefits or else have medicare or medicaid coverage.13 no doubt the argument above has considerable persuasive power. however, i will argue that it is profoundly flawed, morally and politically speaking, and that its persuasive power should be resisted. more specifically, in this essay i will defend four major claims aimed at undermining the persuasive appeal of the argument above. first, it is harder to make fair, reasonable, non-arbitrary judgments of personal responsibility for health than most people realize. second, if an insurer or some legislative body sought to introduce some sort of scheme for assessing personal responsibility for diminished health status (and needed medical therapy), such a scheme would almost certainly violate fundamental moral and political values, especially in a society that sees itself as being politically liberal. third, if such a responsibility-for-health scheme were to be put into practice, the "judges" in such a scheme would likely have to 13 the view expressed in the last two sentences represents a common view among philosophers known as "luck egalitarians." they make a distinction between "brute luck" and "option luck." they defend an egalitarian view with regard to the fair distribution of health care resources for all those whose health care needs are a product of "brute luck," events over which an individual had no control. but they would limit the just claims to needed health care for those whose health needs are a product of "option luck," choices those individuals made that resulted in adverse health consequences for themselves. such individuals, according to luck egalitarians, are justly given lower priority for meeting their self-caused health needs so long as social resources for meeting health needs are relatively scarce. see generally shlomi segall, health, luck, and justice (2009). 2014 557 indiana health law review be physicians whose professional integrity as physicians would be significantly compromised since they would be functioning more like prosecutorial assistants than patient advocates. fourth, if the primary goal of this responsibilityfor-health scheme is to control health care costs and to do that more justly, then the likelihood in practice will be a more unjust state of affairs. or, to put this last point more positively, there are numerous other ways of controlling health care costs justly that do not threaten the just claims to needed health care of those whose health needs may be self-caused in whole or in part. if we had to summarize in a few sentences the key questions we would hope to answer fairly in this essay, it would be these: what may a just, liberal, egalitarian society do by way of tolerating, discouraging, regulating, forbidding, or punishing personal health choices that impose costs on others? or, asked in a slightly different way, is it unjust to deny individuals whose health care needs are products of "irresponsible" behavioral choices equal access to the health care that they need? is it unjust to deny a heart transplant to a smoker or obese individual simply because their heart disease is believed to be a product of their smoking or poor dietary habits? is it unjust to charge smokers or obese individuals very high co-pays for health care interventions related to their smoking or poor dietary habits while excusing other individuals with comparable health problems from such co-pays because those other individuals were believed not to be responsible for their health care needs? my basic answer to all these questions is that those accused of being "irresponsible" with regard to maintenance of their health still have a just claim to equal access to needed health care, except in some rare circumstances. ii. the unbearable arbitrariness of judgments of personal responsibility in health care we start by considering a story intended to illustrate the difficulty of attributing personal responsibility for poor health status in a non-arbitrary way. bishop and brodkey vol. 11:2558 just caring tell us the story of mary jones, a fifty-three year old patient with diabetes and obesity.14 some readers might wish to stop the story there. this is all they need to know to find mary jones guilty of personal irresponsibility for her medical condition. however, these conditions developed after she began to take an atypical antipsychotic drug for her schizophrenia. she is a poor resident of west virginia. her medical bills are covered by medicaid. in order to remain eligible for "full" medicaid coverage (now redescribed in west virginia law as "enhanced" medicaid coverage) she had to sign a treatment contract with medicaid stating that she will keep all her medical appointments, attend diabetes education classes, and lose weight. she did in fact attend one class but became paranoid and left halfway through the class. she has gained five pounds. she has been given educational materials but she does not understand them. she missed her last appointment because she did not have bus fare. her physician is now supposed to report her to medicaid with the consequence that she could lose her mental health benefits. a frequently cited statistic in the medical literature is that roughly 50% of patients are non-compliant with the recommendations of their physicians.' 5 it is easy to 14 see gene bishop & amy brodkey, personal responsibility and physician responsibility--west virginia's medicaid plan, 355 new eng. j. med. 756 (2006). the west virginia medicaid plan has been strongly criticized, in part because it is essentially a "punishment" approach to improving personal responsibility for health, in part because the focus of the plan is the poorest and most vulnerable portion of the population. the american college of physicians has addressed this issue. in a position paper they articulate as their position 2, "incentives to promote behavior change should be designed to allocate health care resources fairly without discriminating against a class or category of people." see generally sheryl mitnick et al., am. coll. of physicians, ethical considerations for the use of patient incentives to promote personal responsibility for health: west virginia medicaid and beyond (2010), available at http://www.acponline.org/running-practice/ethics/issues/policy/persona 1_incentives.pdf, archived at http://perma.cc/lh88-h44p. 15 marie brown & jennifer bussell, medication adherence: who cares, 86 mayo clinic proc. 304, 304 (2011), available at 2014 559 indiana health law review interpret this statistic to mean that half the patients in the health care system are irresponsible with their health. that is, they are being given professional advice by someone who is committed to serving their best health interests. instead of following that advice, having their health restored, and saving the health care system unnecessary health costs related to their non-compliance, they choose to disregard that expert advice and accept ongoing ill health that is likely to generate future health care costs that others in the health care system will have to bear. certainly, mary jones would be described as one of these non-compliant patients. this is a true factual description. but the normative moral judgment is what really matters. is it fair to conclude that mary jones has behaved irresponsibly and is deserving of being denied various mental health benefits because she has behaved irresponsibly? here are some critical questions that might be useful in providing a more dispassionate response to our last question. why is mary jones obese and diabetic? she was given an atypical antipsychotic drug for her schizophrenia that had these side effects. she certainly cannot be responsible for her schizophrenia. should she have informed her physician in a timelier manner of these evolving conditions so that she could be switched to a different medication? that sounds like it was her responsibility to do that. but what if her physician was a bit rushed when he gave her the prescription and was http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3068890/pdf/mayoclinpro c_86_4_007.pdf, archived at http://perma.cc/ly6l-al7l. they write, "the treatment of chronic illnesses commonly includes the long-term use of pharmacotherapy. although these medications are effective in combating disease, their full benefits are often not realized because approximately 50% of patients do not take their medications as prescribed. factors contributing to poor medication adherence are myriad and include those that are related to patients (eg, suboptimal health literacy and lack of involvement in the treatment decisionmaking process), those that are related to physicians (eg, prescription of complex drug regimens, communication barriers, ineffective communication of information about adverse effects, and provision of care by multiple physicians), and those that are related to health care systems (eg, office visit time limitations, limited access to care, and lack of health information technology)."). vol. 11:2560 2014 just caring 561 insufficiently attentive in making sure she understood the potential side effects of this drug? that would seem to diminish her responsibility for these consequences. what if these side effects were more uncommon? or what if these side effects were a result of idiosyncratic features of mary jones' genotype? what if these side effects were well known and mary's physician emphasized strongly that she would need to limit her daily caloric intake to less than fifteen hundred calories to forestall those side effects? mary failed in that effort because it would take something close to heroic will power to achieve that level of self-denial. how should we judge her responsibility for obesity and diabetes under those circumstances? what if there was another antipsychotic drug that she could have been given that would not have these side effects for her, except that this was a much more expensive drug excluded from the medicaid formulary? that would seem to diminish responsibility for her diabetes and obesity. what if from earlier on in life she acquired some problematic dietary habits in the way many adolescents do, a little too much starch and sugar in her diet, not enough to yield diabetes and obesity by themselves, but in combination with this prescribed drug would yield this outcome. here it might be harder to disentangle factors for whose results one might be held responsible from factors for which one could not justifiably be held responsible. mary attended one of the classes she was required to attend but she became paranoid and left. we would not ordinarily hold individuals responsible for failing to control those paranoid thoughts. she was given educational material she could not understand. perhaps she should have taken responsibility and asked a friend to help her understand the material. perhaps her mental disabilities interfered with her ability to make very many friends. perhaps the material itself should have been presented more simply. she missed an appointment because she did not have bus fare. perhaps she should have taken responsibility for setting aside bus fare money at the beginning of the month that could not be used for any other purpose. this is an easy step to take for anyone who is indiana health law review securely in the middle class. can we justifiably believe that it ought to be just as easy for mary? the conclusion i want to draw from this series of critical questions is that it is much more difficult to make some sort of clearly justified global judgment of personal responsibility for health regarding mary jones and whether or not she ought to be denied her mental health benefits by the west virginia medicaid program. my critic might wish to assert that this case is much too idiosyncratic, that it has nothing to do with the very large ethical and policy question of whether ordinary individuals who are not disabled by some severe mental disorder can be held responsible for unjustly imposing health care costs on others through engaging in some range of behaviors that have bad health consequences and high health costs. the usual litany of behaviors would include excessive alcohol consumption, the use of illegal recreational drugs, smoking, dietary habits that increase the risk of heart disease and diabetes, and various sorts of risky sexual behavior. all of these behaviors have been characterized in various religious contexts as being "sinful." but we will pass over that issue for now. instead, we want to examine the very complex causal schemas that are typically associated with "irresponsible" health behaviors that result in serious and costly illness.16 16 philosophers have argued for centuries about free will and determinism. that is a metaphysical debate. i am putting that debate entirely aside for purposes of this essay. my focus is on social practices and social judgments associated with attributing moral or legal responsibility for specific individual behaviors and their consequences. we are often capable of making such judgments well and correctly. for example, if an individual driver has struck and killed a pedestrian walking on the side of a country road, and if that driver had a blood alcohol level of .3 (roughly three times the legal limit), that driver will justifiably be charged with responsibility for that death. that he had a fight with his girlfriend earlier in the day or that his parents were alcoholics will be entirely irrelevant to making that judgment of moral and legal responsibility. but we argue below that it is much more difficult to make such judgments non-arbitrarily when we are supposed to assess responsibility for health outcomes (chronic disease states) that stretch back for decades and that are essentially multifactorial in their origin and evolution. vol. 11:2562 just caring it is morally significant that smoking a cigarette or becoming drunk at one holiday party will not result in either lung cancer or cirrhosis of the liver. these health problems have extraordinarily long and complex causal histories, only a portion of which involve what might be described as responsible behavioral choices by individuals. consider the story of michael. he started drinking at age twelve because this was a cool thing to do with his friends. this behavior continued into college where he was subjected to disciplinary action for several fights and property destruction related to his excessive consumption of alcohol. as he was about to enter law school he reflected on his behavior and decided that his drinking would have to moderate considerably. his father was an alcoholic whose "drinking problem" was tolerated by his mother. both his parents tolerated michael's drinking as well. one might ask at this point whether michael's parents were irresponsible in failing to confront his drinking problem. michael's law career went well for a number of years, but then his firm suffered some serious financial reversals and his marriage fell apart. he again started drinking heavily for several years before some friends were able to steer him into alcoholics anonymous. over the past twenty-five years he has had periods of excessive drinking and sobriety that have each lasted several years. he has now been diagnosed at age sixty-three with cirrhosis of the liver. he has been clean and sober for the past five years. three years ago he volunteered for a genetics research project looking at family history related to alcoholism (or other forms of substance abuse) and individual genotype. that research showed a strong linkage between specific features of his genotype and a vulnerability to alcoholism and other forms of substance abuse.17 the research was well done but it has also had its critics. 17 see mary jeanne kreek et al., genetic induences on impulsivity, risk taking, stress responsivity and vulnerability to drug abuse and addiction, 8 nature neuroscience 1450 (2005); see also richard spanagel et al., a systems medicine research approach for studying alcoholaddiction, 18 addiction biology 883 (2013). 2014 563 indiana health law review how should we assess michael's responsibility for his liver cirrhosis in connection with access to the health care that he needs right now? would it be unjust if he were simply excluded from the liver transplant list because there are not enough livers for everyone with end-stage liver disease, and his disease was likely related to his excessive consumption of alcohol, as opposed to a disease process for which an individual had no responsibility at all? or would it be unjust if he were expected to pay from his own pocket half the $300,000 cost of a liver transplant, unlike everyone else with health insurance for whom virtually the entire cost would be covered by insurance? does it matter that michael has a net worth of less than $50,000? would it be unjust if michael, and michael-like liver transplant candidates, were given very low priority status on the transplant list, such that it would rarely be the case that anyone that far down the list would actually receive a transplant? the point of these questions is that michael would be condemned to a premature death if these questions are answered in the negative. this is reasonably characterized as a severe punishment for his irresponsible health behavior. and it is equally reasonable to characterize such a consequence as punishment, as opposed to regarding this consequence as the outcome of an alternate distributional criterion aimed at achieving a fairer allocation of health care resources. defenders of the use of such severe consequences have contended that these are merely incentives aimed at shaping behavior for the benefit of the individual as well as the good of society. but john harris has noted that if end-stage lung cancer or cirrhosis of the liver is not sufficient to alter the smoking or drinking behavior of individuals, then any additional "incentives" are unlikely to make a difference either.18 he concludes that the most apt characterization of the severe limiting of access to needed health care for those whose ill health is 18 john harris, could we hold people responsible for their own adverse health?12 j. contemp. health l. & pol'y 147 (1995). vol. 11:2564 just caring attributed to personal choices is that they are being punished. 19 if, however, individuals are going to be punished for their "irresponsible" health behaviors, should they not have some formal opportunity to defend themselves against what must be described as "charges"? at the very least, should not physicians be expected to issue a health care version of a miranda warning: "anything you say regarding your bad health behavior can and will be used against you by medicaid, medicare, or your managed care plan." this would certainly have an adverse impact on the doctorpatient relationship. ordinarily patients expect their physicians to be their advocates for good health and the healing of their present infirmities. in order to achieve those desired therapeutic outcomes patients reveal very intimate details of their lives and health-related behavior, some of which may be deeply shameful to them. they do this because they believe this information will be held in confidence (with only a few well-known exceptions) by their physician. if instead physicians inquire diligently about the frequency and magnitude of bad health behaviors so that they can provide more comprehensive indictable information to the patient's insurer or employer, then the physician is really acting more like a prosecutor (albeit a kindly prosecutor aiming to build trust). if our health care system were to evolve in a direction such as this, it would be reasonable to insist that physicians clearly identify themselves either as prosecutorial physicians or as defense physicians so that patients would know to whom they were speaking and what the consequences might be of whatever they might reveal. someone might object that this discussion of punishment is entirely misleading. however, the premise behind this essay is that the need for health care rationing is inescapable, that we cannot afford as a society to meet all 19 id. ("if it is correct that refusals to treat or low positions on waiting lists are unlikely to have much impact on behavior, then discrimination against smokers in the allocation of health care resources will effectively function as punishment and should be seen as such."). 2014 565 indiana health law review the health care needs that we are technically capable of meeting, and, consequently, we need some criteria for determining fairly which health care needs may be given low priority and left unmet. the proposal of some in our society is that individuals whose health needs are a product of self-caused unhealthy choices should have their access to needed health care diminished, directly or indirectly, because they have otherwise imposed an unfair burden on others in our society who will be expected to pay the costs of those unhealthy choices through higher insurance premiums. in being denied what they otherwise would have a just claim to, these individuals are being punished. at this point two critical comments are in order. first, we need to ask again why some individuals are being punished. the short answer is they have made "irresponsible" choices that have resulted in harm to their health and costs that are unfairly imposed upon others in society. this seems like a perfectly general charge. in practice, however, as noted already, the "irresponsible" choices for which individuals are being punished are very limited in number, namely, abuse of alcohol, smoking, drug abuse, bad dietary habits, and assorted sexual "sins." but numerous other kinds of behavior, albeit socially respectable behavior, frequently enough result in harmful consequences to self, but no one is out crusading to have those individuals punished for imposing costs unfairly on the rest of society. women who wear high heels as a fashion statement and injure their ankles would be one example. another example would be avid recreational runners who bang up their knees from running long distances on a daily basis for years and cost someone like myself, a sedate walker, higher taxes and insurance premiums. we could also mention participants in extreme sports, or well-compensated executives who lead very stressful lives, or individuals working in occupations with high levels of accidents and injuries, or couples who choose to have children (imposing costs on the childless). what if a sixty-five-year-old patient has total cholesterol of 210 and is informed by his physician that he has a 14% chance of a heart attack or stroke over the next ten years unless he 566 vol. 11:2 just caring takes a statin, which would reduce that risk by half? he declines the statin because of the side effect of muscle weakness. six years later he suffers a moderate heart attack. all of these examples involve choices that individuals have made voluntarily, knowing that there were health risks that would result in a portion of those costs being imposed upon others who had not made such choices themselves. yet none of these individuals are subjected to social criticism for being "irresponsible," nor are they subjected to punishment in the form of less equal access to the health care they would need for having undertaken those risks. this would suggest that there was something arbitrary and unfair about singling out for punishment (unequal access to needed health care) only a very limited range of behaviors associated with lifestyle choices. likewise, it is difficult to reconcile such an arbitrary and coercive approach to encouraging personal responsibility for health with the fundamental principles of a liberal society. our second criticism related to punishing individuals for self-inflicted health needs is an epistemic point. if individuals are going to be subjected to punishment for "irresponsible" health choices, then there ought to be a high degree of confidence that those judgments of "irresponsibility" have themselves been made responsibly, thoughtfully, and on the basis of a fair weighing of the relevant evidence. recall our patient with the elevated cholesterol who has declined a statin. that heart attack might still have happened, whether or not he was taking a statin. given the current arguments among medical researchers regarding who should be on statins and how effective they are, should we judge this patient to have acted "irresponsibly" regarding his health? what exactly would be the "medical evidence" that would support or refute such a judgment?20 20 something of a medical firestorm was set off with the publication of a two new reports regarding the number of people who ought to be on statins to reduce their risk of stroke or heart disease. the most controversial elements of these reports involved a new risk calculator for determining which patients were at elevated risk for 2014 567 indiana health law review consider again the stories of either mary jones or michael. no doubt both individuals made numerous voluntary choices that each contributed in a small way to their serious health problems. but it is also true that there were numerous non-voluntary causal factors that also contributed to their serious health problems. furthermore, there were other individuals in their lives (mary's physician or michael's parents) who made choices that "might" be characterized as being somewhat irresponsible, given their social roles and responsibilities. those choices too contributed to some degree to the serious health problems with which they are now afflicted. norman daniels also calls attention to failures of social responsibility with regard to health, which he sees as more fundamental and morally problematic than failures at the individual level. 21 he notes, for example, that our federal government has stroke or heart disease. if that risk calculator were introduced into clinical practice today, about thirty-three million more americans would be told they needed to be on statins. see david c. goff et al., 2013 acc/aha guideline on the assessment of cardiovascular risk: a report of the american college of cardiology/american heart association task force on practice guidelines, circulation (nov. 12, 2013), http://circ.ahajournals.org/content/early/2013/1 1/11/ 01.cir.0000437741.48606.98.full.pdf, archived at http://perma.cc/b7rrra25; see also neil j. stone et al., 2013 aca/aha guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the american college of cardiology/ american heart association task force on practice guidelines, circulation (nov. 12, 2013), http://circ.ahajournals.org/ content/early/2013/11/11/01.cir.0000437738.63853.7a.full.pdf, archived at http://perma.cc/6fym-cn4e. these reports were critically assessed by paul ridker and nancy cook, statins: new american guidelines for prevention of cardiovascular disease, 382 lancet 1680 (2013); see also john loannidis, more than a billion people taking statins? potential implications of the new cardiovascular guidelines, 311 jama 463 (2013). the point of these citations is that when there is this intense controversy among medical experts regarding the interpretation and application of these clinical guidelines it seems especially unreasonable and unfair to judge patients as being "irresponsible" should they refuse statins and sometime later suffer a stroke or heart attack. 21 see generally norman daniels, individual and social responsibility for health, in responsibility and distributive justice 266-86 (carl knight & zofia stemplowska, eds., 2011). 568 vol. 11:2 just caring subsidized tobacco production and for a very long time did nothing to regulate cigarette advertising by corporations. 22 the epistemic question (with moral consequences) is that of how we ought to correctly apportion these different factors in arriving at a global "responsibility" judgment that will result in either michael or mary being deprived of needed health care that could result in a premature death for one or both of them. how can we be reasonably certain that we have identified all the responsibility-relevant factors? what do we believe are the relevant norms for correctly assigning the right weight to each of the relevant factors that should contribute to that global "responsibility" judgment? it is not at all obvious that we have such agreed upon norms in our society that we can reasonably and fairly apply to either of our scenarios. nor is it obvious that as a society we are willing to expend very substantial social resources to gather all the information needed for a fair and reasonable judgment in the millions of cases annually that would require such a judgment in the real world. finally, i would ask the reader to imagine michael going through as many as ten cycles of relapse and sobriety of varying lengths over the course of his life. how would we imagine an omniscient divine being judging whether or to what degree michael ought to be punished for his "irresponsible" health-destructive behavior? should that divine being think of michael as a persistent penitent (worthy of mercy and compassion) or as a pusillanimous sinner (worthy only of just condemnation)? at the risk of divine annoyance, my belief is that such an omniscient being would be genuinely stumped, especially if that divine being endorsed as reasonable the liberal pluralistic society in which michael lived. if this is a reasonable thought experiment, then we non-divine and cognitively limited beings ought to be more responsible and restrained when we are tempted to make global judgments of "irresponsibility" for allegedly self-generated health needs and then punish individuals by denying them equal access to the health care that they need. 22 id. 2014 569 indiana health law review iii. political liberalism, value pluralism, and personal responsibility for health we turn now to the question of whether giving legitimacy to policies aimed at punishing individuals for "irresponsible" health choices are compatible with the fundamental values that define what a liberal pluralistic society is. there are many varieties of political liberalism. john rawls and ronald dworkin would represent two such well-known variants. 23 what would seem to be common among these variants would be (1) a commitment to a reasonable value pluralism, (2) a commitment to state neutrality among competing philosophical and religious world views, and (3) respect for some range of equal individual rights. the commitment to value pluralism means that the multiple reasonable values that individuals might use to shape their lives will be equally worthy of respect in the eyes of the state. in other words, there are many ways for citizens in a liberal society to lead good lives that are compatible with the basic political framework of a liberal society. the state itself will not recognize any one value or set of values as superior to all other values, nor will the state establish any preferred hierarchy of values. in general, a liberal society wants to grant individuals a very broad swath of political space in which they can work out for themselves what they judge to be a fulfilling life. the expectation is that individuals may not use their liberty rights to infringe upon the equal liberty rights of others, nor may individuals use their liberty to undermine common or public interests (clean air and water, for example) that the state has the right to protect for the benefit of all. disagreements regarding public policies will be a necessary feature of a liberal pluralistic society, but those disagreements are to be resolved through mutually 23 john rawls, political liberalism (1993); ronald dworkin, sovereign virtue: the theory and practice of equality (2000). though both rawls and dworkin are political liberals and egalitarians, dworkin is committed to the version of egalitarianism known as luck egalitarianism. 570 vol. 11:2 just caring respectful political conversation and constitutionally legitimate political processes. so far as personal responsibility for health is concerned, a liberal state may offer various opportunities for individuals to achieve a better understanding of how they might protect their own health. such educational opportunities are just that-opportunities, which may be freely accepted or freely declined. creating such opportunities is a legitimate public interest. likewise, a liberal society may subsidize the cost of various forms of preventive health care as a way of encouraging individuals to take better care of their health. again, this is an opportunity, not an obligation.24 a liberal society will also respect individuals who choose one dominant value for their lives, such as "maximizing good health." such individuals might impose no "excess" or "unjust" health costs on others, which is admirable. but a liberal society cannot require 24 it must be noted that one other characteristic of liberal societies is a commitment to protecting "fair equality of opportunity." one way in which this is accomplished is by providing free public education through at least high school and heavily subsidized education beyond that. norman daniels has argued that access to needed health is just as important to protecting fair equality of opportunity as free public education. norman daniels, just health: meeting health needs fairly (2008). for example, if individuals with serious chronic health care needs are denied access to the health care that would ameliorate those needs, perhaps because they are denied health insurance or could not afford health insurance, then those individuals will have great difficulty securing or holding even a menial job. id. in that respect daniels contends they are being treated unjustly. id. they do not have fair access to the normal opportunity range of that society. and for this reason he concludes that health care should be thought of as something "morally special," that is, not just another consumer good to be distributed in accord with ability to pay. id. at ch. 2.. if health care is indeed morally special, then there is something morally problematic (unjust) about punishing individuals by denying them access to needed health care because those health care needs were generated by "irresponsible" health choices. this is especially true, as argued in the prior section of this essay, if the "irresponsible" health-related behaviors are somewhat arbitrarily identified and if the causal factors that actually result in a bad health outcome are a complex mix of voluntary factors (the primary focus of attention), and non-voluntary and somewhat voluntary factors (mostly ignored by those who judge these behaviors). 2014 571 indiana health law review that all or any of its citizens adopt this value as a dominant value in their lives, or even as a very important value. the practical implication of this view is that individuals will take various degrees of risk with their health because there are other things they value more highly. every time we drive our cars to get somewhere more quickly rather than less quickly we are putting ourselves and others at risk of an automobile accident that might be due to road and weather conditions or mechanical failure or a brief distraction or poor judgment by another driver or mental fatigue and so on. the consequence will often be injuries requiring medical attention, which means health care costs that others will have to bear "unjustly." that brings us back to our advocates for more personal responsibility in matters of health. they will argue that a liberal society is about rights and responsibilities. that is, we have no right to impose the costs of our "irresponsible" choices on others. but by the same token a liberal society must avoid legitimating what some have described as an "oppressive healthism." 25 where then should a line be drawn? one reasonable response might be that we should simply avoid drawing any such line because we cannot draw that line even in a roughly just way, except perhaps in a very limited range of circumstances. one example of such a circumstance would be the alcoholic who now needs a liver transplant because of his liver disease related to his alcoholism. current practice is that such a transplant candidate must demonstrate sobriety for a period of at least six months before receiving that transplant. this practice is not intended as punishment for irresponsible alcohol use. rather, the concern is that if an individual is so addicted to alcohol that they might go on a drinking binge over several days, they will then fail to take the anti-rejection medications that are absolutely necessary to prevent rejection of the transplanted liver. that liver would then have been wasted. that is, it would otherwise have been 25 see stacy carter et al., shared health governance:' the potential danger of oppressive "healthism" 11 am. j. bioethics 57 (2011). this essay is a critical response to an essay by jennifer ruger, shared health governance, 11 am. j. bioethics 32 (2011). 572 vol. 11:2 just caring given to someone with a 50% chance of ten-year survival with that liver. given the scarcity of this resource and given "fair warning" to individuals in these circumstances, such a practice is neither unreasonable nor unjust.2 6 going back to the "irresponsible" health choices that many make and that result in health care costs "unjustly" imposed on others who do not engage in those same behaviors, what should be done to remedy that "injustice"? perhaps we should be more critical and inquire whether there are true injustices that need to be remedied. the social fact seems to be that virtually everyone takes different risks with their health for different reasons at various times in their lives. a liberal pluralistic society permits and respects such differential choices. some individuals may have "type a" personalities (for whatever reasons, maybe genetics, maybe parental expectations) with the result that they have much more self-imposed stress in their lives with the likely health consequences of that stress. 27 other individuals may be avid skiers or mountain climbers with the risks those hobbies entail. still other individuals may adopt more sedentary habits, such as stamp collecting, which may have adverse health consequences. various dietary choices will have a range of potential health risks associated with them. allowing children to play football or basketball will result in some number of harmful health outcomes. there is gardening in the summer sun or relaxing at the beach. this list can get enormously long if we think hard enough about it. further, if we were committed to being proverbial "health saints" who made health maintenance the absolute highest value in our lives, relative to which all other life activities that carried any risk to health would be foregone, we would have 26 see carl cohen et al., alcoholics and liver transplantation, 265 jama 1299 (1991). 27 we should not forget that such individuals will often be extraordinarily productive members of society. that is, society might benefit greatly from their "stressful" work habits, much more so than any costs their later health problems might impose upon society. surely it would be awkward and inappropriate to accuse such individuals of being "irresponsible" and denying them equal access to the health care they needed for their "choice" of this stressful lifestyle. 2014 573 indiana health law review very dull lives. it is difficult to imagine anyone embracing this as an ideal "good life." under these circumstances the reasonable understanding that we seem to collectively endorse is that we will use the insurance mechanism to effectively pay for our health-related inadequacies, faults, failings, errors, bad choices, and being a bit irresponsible. that is, we agree not to regard the health costs that we impose upon one another as being unjust. we will still chide or encourage one another to watch our weight, get more exercise, wear our seat belts, and so on. that too is encouraged in a liberal pluralistic society because it may achieve some social or personal good non-coercively. 28 we have mentioned genetics several times already, mostly to suggest that an individual's genetic endowment might diminish to some degree that individual's responsibility for a bad health outcome linked to those genetic features. the obvious point is that individuals have no control over their genetic endowment. however, given our rapidly expanding genetic knowledge and related genetic capabilities, there is a different kind of healthrelated "irresponsibility" that also represents a threat to the values that define a liberal society. children born with serious and costly genetic disorders represent a substantial health care cost that is imposed on "others" who are not the parents of such children. clearly the children themselves are not at fault for their genetic endowment, and, if it were twenty years earlier, we would say the same of the parents. however, what we have today is the capacity to do whole genome sequencing for less than $5000 as well as preimplantation genetic diagnosis ("pgd").29 the practical 28 for a critical assessment of using social policies to bring about greater personal responsibility for health, see daniel wikler, persuasion and coercion for health: ethical issues in government efforts to change life-styles, 56 milbank memorial fund. q. 303 (1978). likewise, elizabeth anderson is concerned, as a political liberal, that such government efforts would effectively erase the line between the public and the private to the detriment of individuals. elizabeth anderson, what is the point of equality? 109 ethics 287 (1999). 29 carol caddwalladr, what happened when ihad my genome sequenced? guardian (june 8, 2013, 2:45 pm), vol. 11:2574 just caring implication of these medical advances is that future possible parents have a significant capacity to choose the genetic endowment of their future possible children. 30 the obvious question that can be posed is: are such future possible parents rightly judged to be "irresponsible" if they fail to avail themselves of these medical options in order to make a more responsible choice of a future possible child? current predictions are that in the next year or two we will have the ability to do whole genome sequencing for $1000.31 could a liberal pluralistic society require that all marital partners intending to have children have such a test so that a couple could then know what significant genetic risks were possible for their future possible children so that they could make a more responsible choice regarding the genetic endowment of those children? armed with such knowledge, a couple could then conceive using in vitro fertilization to produce a dozen or so embryos grown to the eight-cell stage when they would then be genetically analyzed, thereby allowing the couple to responsibly choose the "least flawed" embryo. the cost of pgd is about $40,000-60,000 for a successful pregnancy. 32 would such a policy be any less illiberal if the federal government, as a way of showing social responsibility, paid for this testing? further, would strong advocates for the right-to-life http://www.theguardian.com/science/2013/jun/08/genome-sequenced, archived at http://perma.cc/kb6f-ajcz. 30 see leonard fleck, do future possible children have a just claim to a sufficiently healthy genome? in medicine and social justice: essays on the distribution of health care 446-57 (rosamond rhodes et al. eds., 2002). 31 see ashlee vance, illumina's new low-cost genome machine will change health care forever. bloomberg business week (jan. 15, 2014). http://www.businessweek.com/articles/2014-01-15/illuminas-newlow-cost-genome-machine-will-change-health-care-forever, archived at http://perma.cc/p7dg-amyg. 32 see reproductive health technologies project, pre-implantation genetic diagnosis http://www.rhtp.org/fertility/pgd/ (last visited may 14, 2014), archived at http://perma.cc/q3dv-7daf. as noted in this article the cost for ivf is about $9,000 per cycle and the cost for pgd will be $4,000-$7,500 per cycle. on average three cycles are needed for a successful pregnancy, which yields a likely cost of $40,000-$60,000 for a successful pregnancy. 2014 575 indiana health law review perspective have just cause to complain because their tax dollars would be used to underwrite the cost of a procedure that involved the disposal or destruction of numerous excess embryos? what seems clear is that these potential policies are clearly incongruent with respect for individual rights and other basic liberal commitments. but an unqualified emphasis on personal responsibility for health would have such potential consequences as a practical implication.33 iv. physician integrity and personal responsibility for health if patients are going to be punished via some diminishing of health benefits to which they would otherwise be entitled because of "irresponsible" health choices that created some specific health needs, then someone will need to make the judgment that some current health need is linked to clearly "irresponsible" healthrelated behavior. the obvious candidate for such a role is a patient's physician. however, physicians are trained to be compassionate and nonjudgmental. this is what patients legitimately expect. further, patients with serious illness are often anxious, vulnerable, and largely dependent upon medical expertise and advice. physicians should not impose their personal values on patients. this is because (1) 33 a similar sort of example related to alleged parental "irresponsibility" can be brought up with regard to the obesity epidemic. some medical research suggests that the fetal environment and maternal choices may result in a permanent altering of the endocrine-metabolic status of the fetus, thereby making the fetus more vulnerable to either diabetes or obesity later in life. kanaka-gantenbein concludes that "both intrauterine nutrient restriction as well as intrauterine excessive supply may predispose for the development of adult diabetes." christina kanakagantenbein, fetal origins ofadult diabetes, 1205 annals n.y. acad. scl. 99 (2010); see also kristin wartman, bad eating habits start in the womb, n.y. times (dec. 1, 2013), http://www.nytimes.com/2013/12/02/opinion/badeating-habits-start-in-the-womb.html?emc=etal& r=0, arclived at http://perma.cc/f7cz-hlss. again, putting in place any policy that was aimed at "supervising" parental eating behavior in this context would be an incredibly intrusive violation of individual privacy rights that should not be judged as a fair or reasonable way of correcting these alleged instances of parental "irresponsibility." 576 vol. 11:2 just caring patients are fearful and vulnerable; (2) physicians are in a more powerful position because of their social authority and medical expertise; and (3) the authority that physicians have is granted to them by the state for a public purpose, not as an opportunity to recruit patients as supporters of their personal religious or ideological beliefs and values. no one doubts that physicians should legitimately advise and educate patients about their health problems. physicians should encourage patients to quit smoking, watch their weight, exercise more, and so on. but physicians must refrain from coercing or manipulating patients to achieve health outcomes that competent patients do not autonomously embrace. physicians are clearly open to moral criticism if they coerce or manipulate patients into making choices that are more congruent with that physician's personal values. but this is equally true if physicians allow themselves as physicians in the doctor-patient relationship to be used to impose preferred social or political values not congruent with the core moral commitments of medicine. this is what seems to be happening in the west virginia case of mary jones discussed earlier. that is, physicians are being used to gather "evidence" that will be used by a third party (the state or an insurance company) to punish patients for aberrant health behavior. in such a situation physicians are no longer trustworthy agents of their patients' health interests. instead, they are acting as health police assisting someone functioning as a health prosecutor to identify and punish health criminals without the benefit of a trial or other due process protections. this would clearly alter for the worse the doctor-patient relationship. at the very least patients who were mindful of this conflict of interest would be motivated to lie or withhold therapeutically relevant information, potentially at risk to their own health. physicians are supposed to be nonjudgmental. but if physicians are expected to gather evidence for insurers of miscreant health behavior by their patients, then they are being quite judgmental. further, there is ample opportunity in such circumstances for the most arbitrary and subjective of judgments. we can imagine that insurers 2014 577 indiana health law review might wish to "keep things simple" and focus on a few bad health behaviors, such as smoking, consuming fatty foods, alcohol and drug abuse, and promiscuous sexual behavior. as noted earlier, these are the sorts of behaviors that have a "sinful" caste to them. physicians would be behaving in a distinctly illiberal way if the focus of their reporting "irresponsible" health outcomes were these behaviors. beyond that, what physicians are doing for the third parties seeking this information is certifying that these patients have made "irresponsible" behavioral choices. as noted earlier, however, it would be very unlikely that most physicians would invest the time and effort needed to do a thorough assessment of the complex causal factors (genetic, social, environmental) stretching back several decades in the case of a michael-like patient for purposes of judging fairly the degree to which a patient before them now was "responsible" for their current health need. in other words, such judgments would quite likely be very arbitrary and subjective, hardly a reasonable basis for determining whether someone did not have an equal just claim to needed health care. finally, physicians have very strong obligations to protect confidentiality, and patients have strong privacy rights. but neither is absolute. tarasoff v. regents of the university of california showed that health professionals have a "duty to warn" that trumps obligations of confidentiality when there is the risk of serious, imminent, and irreversible harm to self or others, and there is no alternative way of averting hat harm except by a breach of confidentiality. 3 4 in that case a young man told his psychologist that he intended to kill his former girlfriend. it was apparently clear that this was a genuine intent, not simply an angry fantasy. hence, the conditions for invoking the "duty to warn" were satisfied. but if that young man had, instead, expressed intent to defraud that young woman of $1000, the conditions for invoking the "duty to warn" would not be satisfied. this would not be an irreversible harm, nor would it be serious enough to justify a breach of 3 see tarasoff v. regents of the university of california, 17 cal. 3d 425, 440-41 (1976). vol. 11:2578 just caring confidentiality. likewise, if a patient's bad health behavior imposes "unjust" health costs on others, this would not provide sufficient justification for a physician to breach confidentiality by revealing all manner of private information about a patient's personal health choices for purposes of helping the state or an insurance company punish that individual's "irresponsible" health behavior. further, if the need to control health care costs is what has drawn attention to unhealthy personal behavior, then we are morally obligated to inquire whether there are alternative ways of controlling health care costs that do not have the moral costs associated with punitive efforts to reshape unhealthy personal behavior. we turn next to addressing the health care justice issues related to making judgments of personal responsibility for health. v. personal responsibility for health and health care justice earlier in this essay we argued that it was less than obvious that patients who were judged to have made "irresponsible" health choices had unjustly imposed health care costs on others. for the sake of argument we are going to put aside that claim. instead, we will concede that individuals who have been less than fully responsible in caring for their health and who now have serious and costly health needs related to that less than responsible healthrelated behavior have added unnecessarily (and unjustly) to the problem of escalating care costs. hence, if we need to do something to control escalating health care costs for society, then it is not unjust if society either forces these individuals to internalize those costs or else forego the health care that they otherwise need. this is not an unreasonable argument but i will still argue that it is less than adequately persuasive. our health care system is riddled with injustices, at least as judged from a moderately egalitarian perspective. but it is not as if all injustices are equally unjust. some injustices are worse than others. a good moral rule would be that greater injustices ought to be remedied before lesser 2014 579 indiana health law review injustices. what i want to argue in this concluding section is that there are more serious injustices in our health care system than the alleged injustices associated with "irresponsible" health-related behavior by individuals. space does not permit an entire treatise on competing theories of health care justice as applied to the problem of health care rationing and cost containment. my own view is that none of these competing theories of health care justice can address adequately the complex problems of health care justice within the american health care system. what we need instead is a pluralist account of health care justice. 35 put simply, such an account will require a careful balancing of considerations of liberty, equality, social utility, efficiency, and effectiveness. there is no algorithm that tells us how these different considerations should be balanced or weighted in relation to each other in specific rationing contexts. this will be a matter of what john rawls refers to as wide reflective equilibrium and rational democratic deliberation, the latter being constrained by what i refer to metaphorically as "constitutional principles of health care justice."36 the starting point for thinking about health care justice must be the claim that health care is "morally special." for the most part health care is not just another consumer good to be distributed in accord with an individual's ability to pay. it is appropriately a matter of justice. there are two important reasons for concluding that health care is a matter requiring just distribution. first, health care today is closely related to protecting "fair equality of opportunity." individuals who are denied access to needed health care and suffer the functional deprivation linked to unmet health care needs will also be denied access to what norman daniels refers to as the "normal opportunity range" of a 35 i argue at length for this view in my book. see leonard fleck, just caring: health care rationing and democratic deliberation ch. 4 (2009). 36 id. at ch. 5 (explaining in detail there what these constitutional principles of health care justice are, how they come to be articulated, how they are balanced in relation to one another, and what their role is is establishing "boundaries" for democratic deliberation and what may be regarded as a legitimate outcome of that deliberative process). vol. 11:2580 just caring society.37 second, health care in the united states is properly thought of as largely a "public good," a product of enormous social investment in medical research, training highly skilled health professionals, and building health facilities. virtually all in our society, whether insured or not, have paid through taxes for the creation of this system to which they ought to have fair access. this is essentially the basis for a moderate egalitarian perspective on health care justice. a liberal moderate egalitarian is committed to the view that all in our society deserve equal concern and respect with regard to access to needed health care. further, the relevant basis for determining how health care ought to be distributed justly is need, not social worth, not desert, not ability to pay. as noted earlier, however, health care needs are endless and social resources for meeting those needs are limited. hence, we need to consider how to make rationing decisions fairly. the fundamental commitment of the liberal moderate egalitarian is that individuals in similar clinical circumstances with similar health care needs ought to receive equal access to that needed health care. if two individuals in their fifties have early stage colorectal cancer, and if the cancer is equally treatable for both individuals, but if only one individual has the ability to pay the $30,000 cost of that treatment (which will allow him to live another twenty years), and if the other individual is denied that treatment for lack of ability to pay (which will result in his premature death four years later), then that latter individual has been treated unjustly from the perspective of a liberal moderate egalitarian. here is another scenario. if both these individuals above have stage iv metastatic colorectal cancer, and if the only intervention that might prolong their lives an additional five months is a $100,000 drug, such as bevacizumab, and if there is a rationing protocol that has been approved through a fair process of democratic deliberation that would deny anyone in these medical circumstances this drug because it yielded too little medical good at too high a price, and if both 3 see daniels, supra note 27. 2014 581 indiana health law review these individuals are denied this drug at social expense, then this is perfectly acceptable to a liberal moderate egalitarian. that is, neither has been treated unjustly. both have been denied a bit of life prolongation. but the moral justification would be that the resources thereby saved could be redeployed to meet other higher priority health care needs as judged from a moderate egalitarian perspective. more specifically, those resources could be redeployed to meet the health care needs of our uninsured fifty-year old with a treatable early stage cancer that will result in a greater medical good (sixteen more years of life) at a much lower cost than for bevacizumab for a stage iv cancer. 38 next imagine a scenario with george and harry. both are sixty years old; both are in stage iv heart failure. both have a predicted life expectancy of less than two years. george has had two heart attacks in the past three years. he has been reasonably attentive to his diet and weight all his life. he has a body mass index of twenty-six (only very slightly overweight). harry has also had two heart attacks in the past three years, but he has a body mass index of thirty-one (which identifies him as being obese). harry has a life story rather like michael's life story. both his parents were obese; they tolerated his consumption of high fat and high calorie foods. harry has tried and failed multiple diets during his life. he is genetically predisposed to high cholesterol levels; he has tried several statins but was discouraged by side effects, mostly muscle weakness, which was a problem for him as a construction worker. both george and harry need a left ventricular assist device ("lvad") at a cost of $200,000 to gain an extra two years of life. both have the same insurance company and the same plan. george's lvad will be paid for by his insurance but 38 it should be noted that there are now more than forty of these cancer drugs that are fda approved and that have costs for a course of treatment in the range of $50,000-130,000. none of these drugs cure an advanced cancer. most of them can promise on average extra weeks to extra months of life. see tito fojo & christine grady, how much is life worth? cetuximab, non -small cell lung cancer, and the $440 billion question, 101 j. nat'l cancer inst. 1044 (2009). vol. 11:2582 just caring that same company is requiring harry to pay $100,000 of the cost because he has been judged responsible for his heart disease. harry is unable to pay that without leaving his future widow impoverished. i argue that this outcome for harry is unjust from a liberal egalitarian perspective. first, as argued earlier, there is considerable complexity and uncertainty associated with making a fair judgment that harry is responsible for his late-stage heart failure but george is not. after all, george did a lot of weightlifting for exercise, which might have contributed to his having those heart attacks. but no one ever asked him about that, nor would that have made a difference with his insurance company. this sort of arbitrariness is alien to a liberal egalitarian conception of health care justice. if the lvad were substantially less likely to yield the same level of quality-adjusted life years gained for harry as opposed to george, that would be a justice-relevant consideration which would justify a differential allocation. but the best medical evidence would predict that they are equally likely to benefit. by way of contrast, the judgment of "irresponsibility" attached to harry is much less soundly evidentially based, which is a second reason why this outcome is presumptively unjust. third, as i have argued elsewhere, just rationing protocols ought to be a product of fair processes of rational democratic deliberation. 39 what we have to assume is that virtually everyone wants health care costs controlled, which is what creates the need for health care rationing. so we have to imagine ourselves as deliberators who are in basically good health and who are ignorant of what our future health care needs might be, including the degree to which we might be judged "responsible" for those needs. deliberators would be urged to keep in mind the number of americans beyond age fifty who are overweight or obese, the point being that that could be a future possible self for any of us. still, i might be tempted to say that i am certain i will never be an alcoholic or drug abuser, and, consequently, i might be initially inclined to endorse a 3 see fleck, supra note 36, at ch. 5. 2014 583 indiana health law review rationing protocol that would deny expensive life-prolonging care to individuals whose life-threatening health needs are related to alcoholism or drug abuse. but then i might be reminded through the deliberative process that i have family or friends or co-workers who have struggled with these issues. i care about them and i am very familiar with their struggles and why they have had these struggles. consequently, i would not want to see them die prematurely if there is medical care that can effectively address their medical problems. rationing decisions still need to be made. these rationing decisions must be ones that all could accept as "reasonable enough" and as "fair enough," given a fundamental commitment to equal concern and respect for all. thus, we might all agree that if we were in late stage heart failure and in an advanced state of alzheimer's disease (or comparable irreversible cognitive decline), we would deny our future possible selves an lvad so that if, instead, i were in late stage heart failure for any reason at age sixty i would have access to an lvad at social expense. the moral advantage of such a deliberative process is that it is public, transparent, rational (based on the best medical and scientific evidence available), and autonomously selfimposed (unlike judgments of personal "irresponsibility" made by self-authorized health saints and imposed on saint adjudicated health sinners). this is what rawls refers to as "fair terms of cooperation."40 if we could get beyond the vituperative political rhetoric that has characterized public conversation for the past decade we would easily collectively identify numerous rationing protocols such as the one above that would be fairer than any of the demands for punishing those identified as having made "irresponsible" health choices. finally, individuals should take more responsibility for their health. and our society should create a social and economic and educational environment wherein that can happen more easily. but i want to resist the claim that personal responsibility for health must be an integral part 40 see rawls, supra note 26, at lecture six, the idea of public reason. 584 vol. 11:2 just caring of our conception of health care justice. the moral risk of such integration is that we would create two classes of patients: the deserving healthy (who would get a superior standard of care) and the undeserving unhealthy (who would get an inferior standard of care). our conception of health care justice would then be desert-based rather than need-based. this is not an outcome that would be congruent with a liberal egalitarian conception of health care justice. consider the following example. james is 88 years old. he has been reasonably attentive to his health. he has also been blessed with an excellent genotype which has allowed him to age well. but he is now faced with some serious heart disease, mostly related to normal aging. over the next several years he is treated with several somewhat expensive medications to ease the burden on his heart. he also needs coronary angioplasty to keep open a couple coronary arteries that have narrowed. altogether he has been the beneficiary of about $110,000 worth of health care over the past four years. but he now has end-stage heart failure, just like george and harry. but the lvad will not do him enough good. he needs a totally implantable artificial heart ("tiah") at a cost of $300,000. such a device promises on average five extra years of life expectancy. if our conception of health care justice is desert-based, then we would have no basis for denying his request, even though his longevity is likely as much a product of his genotype and his social environment ("brute luck") as his attentiveness to his personal health ("option luck").41 let us add to this scenario a variant of harry. harry is sixty years old. his heart failure is such that an lvad will not be good enough to prolong his life. he too needs a tiah. because 41 various writers have called attention to the role of social environment in support of personal responsibility for health. or, put another way, there will be more "irresponsibility" for health among social groups that are the objects of various forms of social discrimination as well as among individuals in the lower reaches of the economic spectrum in our society. see, e.g., susan hurley, the public ecology of responsibility, in responsibility and distributive justice 187-215 (carl knight & zofia stemplowska eds., 2011); see also daniels, supra note 27. 2014 585 indiana health law review he is younger, however, his predicted life expectancy with the tiah would be an additional ten to fifteen years. though harry is insured, he would be expected to cover $150,000 of the cost of the tiah. he cannot afford that. there is something fundamentally unjust in this state of affairs. at the very least harry is being denied the opportunity to achieve a normal life expectancy when the medical technology is available that would make that possible. at the same time james is being "rewarded" with a substantially enhanced life expectancy, far beyond a normal life expectancy, and this is a social expense. that is, we are all paying for that enhancement. or perhaps we could say that the resources saved by allowing harry to die are being transferred to james so that he might reach age ninety-seven. we can identify the justice concerns in yet another way. cancer is largely a disease of older individuals. we can imagine james with his artificial heart afflicted with a pancreatic cancer at age ninety-four. again, this will just be a matter of brute (bad) luck. so if we adopt a desert-based luck egalitarian perspective rather than a liberal egalitarian perspective, then we would again be obligated as a matter of justice to provide james with a $100,000 cancer drug that might yield only three extra months of life for james (above what he would get without the drug). from a cost-effectiveness perspective the cost of this drug would be $400,000 per quality-adjusted life year ("qaly"). the point is that james-like individuals who have been very fortunate health-wise would have a moral right (just claim) to unlimited marginally beneficial and extraordinarily costly health care while harry-like individuals would be denied very cost-effective health care that was necessary for them to achieve a normal life expectancy. to be precise, if harry gained just ten extra years of life with the tiah, the cost per qaly would be $30,000. we return to our rational democratic deliberation. if we were relatively young and in good health, and if we could see our future possible selves as harry-like or james-like individuals (the same being true for others about whom we cared deeply), and if we sought fair terms of cooperation 586 vol. 11:2 2014 just caring 587 with regard to the allocation of limited health care resources, and if we were committed to equal concern and respect for all, then would we see a conception of justice that yielded the james-like results described above as being "just enough"? it is difficult to imagine an affirmative answer emerging from this deliberative process, much less the reasons that would justify such an outcome. in the final analysis trying to control health care costs by denying equal access to individuals whose health care needs are judged a product of "irresponsible" behavior will be illiberal, unjust, uncaring and threatening to the values central to the practice of medicine. safer is better: paving the path for safe consumption sites in indiana alexis weaver* i. introduction david1 was an outstanding musician. whether on guitar, piano, ukulele, or harmonica, dave could wail on them all. he was a voracious reader, animal lover, and unapologetic coffee snob. he possessed a fiery temper; one that would color his whole face and neck in a deep crimson and highlighted his freckles and bright, brown eyes. he had a quick smile and a quicker wit. and, he was seldom seen without a cigarette tucked behind his ear. marlboro reds: just one of a number of vices, most acquired too young. dave aspired to a career in music as his father had, dreaming to make a profession out of their shared passion. after his dad died, following a brief illness, he played with renewed ferocity and willed hours away, pouring over his father’s unfinished compositions. his struggles with substance use also increased with unmitigated vigor. yet, he projected his normal persona: sharp, bright, creative, and charming. he registered for college classes, started writing his own music, and even bought a new car. a week after the purchase, he was found dead inside of it in an abandoned parking lot. he was 26. “an overdose is often a lonely way to die.”2 one of the most consistent patterns among the tens of thousands of national overdose deaths in recent years is that the victim’s last moments went unobserved.3 this is because, often, with someone else present, the hallmark signs of an overdose – blue lips, restricted pupils, and loss of consciousness – spurn witnesses to get help fast.4 when this happens, many overdoses can be reversed with tools such as naloxone and prompt medical attention.5 without intervention, the victim is left to die. * j.d. / m.p.a. candidate, 2021, indiana university robert h. mckinney school of law; b.a., 2017, indiana university–purdue university indianapolis, indianapolis, indiana. 1. the individual referred to as david or dave was a personal friend. to maintain his privacy, his name has been changed for the purposes of this note. 2. the editorial bd., let cities open safe injection sites, n.y. times (feb. 24, 2018), https://www.nytimes.com/2018/02/24/opinion/sunday/drugs-safe-injection-sites.html [https://perma.cc/a9s5-yjxp]. 3. provisional drug overdose death counts, nat’l ctr. for health stat. (mar. 11, 2020), https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm [https://perma.cc/r4fe-6xrv] (explaining that drug overdoses are often classified as “pending investigation[s],” while an official cause of death is determined). 4. id. 5. id. 216 indiana health law review [vol. 18:215 in 2017, more than 1,800 people died as a result of a drug overdose in indiana.6 dave was among them. this number represents the highest number of drug overdose deaths ever recorded in the state at 29.4 per 100,000 residents.7 this figure also illustrates a 22% increase in overdose deaths since 2016, awarding indiana the grim third-place prize for the highest increase in overdose deaths in the nation over that single-year period.8 what the figure does not illustrate is the grief felt by those closest to the deceased. it does not account for the hours that parents drove around in cars, looking for their sons and daughters, hoping to find them before they overdosed alone on the streets. it does not observe the panic felt by spouses who found their partners and frantically administered narcan, hoping this time was not the time. it does not take stock of the thousands of painful phone calls to friends and family, delivering the dreaded and devastating news. this was the call that i got. the call that too many of us get. when you love someone who suffers from chronic substance use disorder, the reality that they may, as a result of their illness, join the ranks of the faceless, nameless statistics is a daily agony. this agony is compounded by the knowledge that such a death is not an unavoidable fate for those suffering from substance use disorder. these deaths are preventable. substance use disorders are part of a class of disorders listed in the diagnostic and statistical manual of mental disorders, fourth edition that is characterized by “the taking of drugs of abuse (including alcohol).”9 in 2014, 21.5 million americans over the age of 12, or roughly 8% of this population, experienced a substance use disorder within the prior year.10 about 30% of those substance use disorders were related to illicit drug use.11 substance use disorders are diseases and are treatable.12 however, for so many, treatment resources and treatment facilities are inaccessible or nonexistent.13 6. div. of trauma & injury prevention, drug overdose epidemic in indiana: behind the numbers, ind. st. dep’t health 2 (apr. 2019), https://www.in.gov/isdh/files/85_drug% 20overdose%20data%20brief_2019.pdf [https://perma.cc/m7rw-kpwe]. 7. id. 8. id. 9. cristie glasheen et al., impact of the dsm-iv to dsm-5 changes on the national survey on drug use and health 5 (2016), https://www.ncbi.nlm.nih.gov/ books/nbk519697/pdf/bookshelf_nbk519697.pdf [https://perma.cc/h9lj-ya6s]. 10. sarra l. hedden et al., behavioral health trends in the united states: results from the 2014 national survey on drug use and health 2 (2015), https://www. samhsa.gov/data/sites/defau lt / files/nsduh-frr1-2014/nsduh-frr1-2014 .pdf [https://perma.cc/a8kz-jgex]. 11. rachel n. lipari & struther l. van horn, trends in substance use disorders among adults aged 18 or older, substance abuse & mental health serv. admin. (june 29, 2017), https://www.samhsa.gov/data/sites/default/files/report_2790/shortreport-2790.html [https://perma.cc/za72-v6d2]. 12. id. 13. christine vestal, still not enough treatment in the heart of the opioid crisis, pew 2021] safer is better 217 chronic illnesses are characterized by periods of remission and relapse.14 substance use disorders are no different, and those suffering from them experience alternating periods of sickness and health just as with any other chronic disorder.15 studies consistently and conservatively find that recurrence of symptoms – that is, periods of substance use – is experienced by over 85% of individuals suffering from substance use disorders.16 these statistics, though dismaying, are empowering: we know people with substance use disorders are going to experience periods of substance use, as part of the disease. this understanding is empowering because it gives policymakers and public health and safety officials a clear goal: reduce deaths associated with these periods of substance use. evidence-based findings clue policymakers into what can effectively reduce these overdose deaths: harm reduction strategies. namely, such include safe spaces for people experiencing substance use disorders that do not criminalize or set unrealistic abstinence-only expectations. this is where safe consumption sites come in. a. roadmap this note will aim to do three things. first, it will posit the public health need for the implementation of safe consumption sites by compiling the data on overdose deaths, the transmission of disease through unsafe substance use practices, and lack of access to treatment. this section will also showcase the economic costs of increasing rates of substance use disorder and its associated harms. second, it will give an overview of safe consumption sites, including the history of their implementation and efficacy abroad, the national landscape for the introduction of sanctioned sites in the united states, and recent developments regarding the legal status of these sites. the final portion of this note will endeavor to analyze the path forward for the establishment of a site in indiana. this section will dissect existing indiana code provisions to (1) propose how a safe consumption site could be piloted; (2) suggest changes to the code to fully realize the legal establishment of a site; (3) critique other existing indiana drug law that would hinder efforts to establish and maintain a site; and (4) propose a strategy for advocacy for the creation of a pilot site as a vital public health necessity. charitable tr. (sept. 26, 2016), https://www.pewtrusts.org/en/research-and-analysis/blogs/ stateline/2016/09/26 /st ill-not-enough-treatment-in -the-heart-of-the-opioid-crisis [https://perma.cc/h3q2-afjv]. 14. william l. white & a. thomas mclellan, addiction as a chronic disorder: key messages for clients, families and referral sources, 9 couns. 24, 30 (2008). 15. id. 16. rajita sinha, new findings on biological factors predicting addiction relapse vulnerability, 13 current psychiatry rep. 398, 398 (2011). 218 indiana health law review [vol. 18:215 ii. an issue of public health the perception of substance use as a moral failing has prevented efficacious treatment of what science has shown us, for decades, is a disease.17 the ongoing opioid crisis is often framed as a new epidemic, when, in actuality, we are merely experiencing the latest wave of an ongoing and decades-long problem of opioid and other substance abuse in america.18 the trends in indiana opioid-related deaths have followed the similar three-wave pattern experienced nationally. wave 1 in the 1990s was primarily driven by prescription opioid deaths.19 wave 2 in the midto late-2000s was characterized by a significant increase in heroin overdose deaths.20 wave 3, corresponding to the current crisis narrative, began around 2014 and has been stimulated by a dramatic rise in synthetic opioid overdose deaths that are primarily fentanyl-related.21 while the most recent wave of overdose deaths presents its own unique political and public health challenges, and as public health and safety officials scramble to figure out how to confront and stem the flow of deadly illicit fentanyl into the market,22 these symptoms are emblematic of a greater underlying problem: how we confront and treat substance use disorders broadly. historically, the united states has approached substance use mitigation efforts primarily through the criminalization of drug use and possession.23 however, over a decade of evidence-based data shows that rather than mitigating substance use and associated overdose deaths, criminalization as a primary strategy actually exacerbates the problem by creating barriers to health and treatment for people with an opioid use disorder.24 according to human rights 17. see nora d. volkow & joanna s. fowler, addiction, a disease of compulsion and drive: involvement of the orbitofrontal cortex, 10 cerebral cortex 318 (2000) (analyzing addiction as a disease). 18. opioid data analysis and resources, ctr. for disease control & prevention, https://www.cdc.gov/drugoverdose/data/analysis.html [https://perma.cc/2abn-pu2w] (last updated mar. 19, 2020). 19. understanding the epidemic, ctr. for disease control & prevention, https://www.cdc.gov/drugoverdose/epidemic/index.html [https://perma.cc/9rzb-3rul] (last updated mar. 19, 2020). 20. id. 21. div. of trauma & injury prevention, supra note 6, at 3. 22. caroline carney, 4 strategies for combatting the third wave of the opioid epidemic: fentanyl, am. j. managed care (june 13, 2019), https://www.ajmc.com/contributor/carolinecarney/2019/06/4-strategies-for-combatting-the-third-wave-of-the-opioid-epidemic-fentanyl [https://perma.cc/e5pq-d9r2]. 23. christopher j. coyne & abigail r. hall, four decades and counting: the continued failure of the war on drugs, cato inst. (apr. 12, 2017), https://www.cato.org/publications/ policy-analysis/four-decades-counting-continued-failure-war-drugs [https://perma.cc/u7ln-7t9z]. 24. human rights watch, every 25 seconds: the human toll of criminalizing drug use in the united states 165 (2016). 2021] safer is better 219 watch, criminalization drives drug use underground; it discourages access to emergency medicine, overdose prevention services, and risk-reducing practices such as syringe exchanges.25 when these barriers are erected on a systematic basis, there can be little surprise when overdose deaths soar. recognition of substance use disorder as a disease, rather than a criminal act, can begin to dismantle those barriers. rather than setting impossible and unrealistic standards, policymakers need to get serious about combatting increasing overdose death rates and embrace one of the few proven methods of improving quality and quantity of life for those suffering from substance use disorder: harm reduction.26 a. data on the public health impact in 2017, the last year for which we have national publicly available data, more than 70,000 americans died of an accidental drug overdose.27 this staggering number represented nearly a 10% increase in national accidental drug overdose deaths from only the year before,28 signifying the ongoing nature of the public health crisis related to substance use disorder. indiana deaths outpaced both the national average of overdose deaths per capita and the year-to-year increase from 2016 to 2017.29 in marion county, specifically, a more nuanced and up-to-date data set is available. the indiana university public policy institute’s center for health and justice research was able to “combine death reports, toxicology reports, and information from police reports to provide a more holistic view of the circumstances surrounding a person’s death” and to determine what substances and usage practices were contributing to overdose deaths.30 this review found that of the 361 overdose deaths in marion county in 2018, those resulting from heroin and prescription opioids were down slightly from 2017. however, those deaths attributable to methamphetamine and cocaine were up.31 alarmingly, accidental overdose deaths, which involved fentanyl, were significantly higher than in 2017, and fentanyl was a contributor in 54% of all 25. id. 26. nathaniel gunn et al., primary care as harm reduction for injection drug users, 280 jama 1191, 1191 (1998). 27. drug overdose deaths, opioid overdose, ctr. for disease control & prevention, https://www.cdc.gov/drugoverdose/data/statedeaths.html [https://perma.cc/9qju-p3nr] (last updated mar. 19, 2020). 28. div. of trauma & injury prevention, supra note 6. 29. id. 30. new numbers show drop in overdose deaths in marion county, ind. univ. pub. pol’y inst. (july 18, 2019), https://policyinstitute.iu.edu/news-media/stories/overdose-deaths-2019.html [https://perma.cc/jv4d-dvvv]. 31. leslie wells, chjr researchers examine drug overdose deaths in marion county, ind. univ.–purdue univ. indianapolis (july 22, 2019), https://blog.oneill.iupui.edu/2019/07/22/2018overdose-deaths/ [https://perma.cc/6ect-4mrw]. 220 indiana health law review [vol. 18:215 marion county accidental overdose deaths.32 this type of information can clue public health officials in on the spike in fentanyl-laced illicit drugs being introduced in marion county. such public health data is crucial to arming harm reduction coalitions with the proper and effective supplies, such as more fentanyl testing kits. public health is not merely impacted by the number of accidental overdose deaths that result from inadequate community responses to the needs of people with substance use disorders. the morbidities associated with substance use also greatly impact public health at large. one of the most obvious ways this is borne out is in the elevated rates of infectious disease transmission driven by the sharing of needles and other equipment during intravenous drug use. both of these are critical data points in developing a strategy to reduce the mortalities and morbidities associated with substance use disorder. they inform public health professionals on what is critically needed: (1) equipment to help screen for deadly fentanyl contamination, and (2) sterile and safe equipment. the next question is how to distribute these tools to this vulnerable population when doing so can cause criminal consequences for this already highly stigmatized and marginalized group. when access to sterile equipment and spaces needed for safe substance use is denied to people with substance use disorders, or when access to such resources is criminalized, it has no effect on reducing substance use.33 rather, it has the inverse effect of increasing unsafe substance use that contributes to increased overdose deaths and disease transmission.34 the centers for disease control and prevention are clear on the measurable impact of substance use related to intravenous drug use, saying “injection drug use . . . is a risk factor for contracting blood-borne pathogens such as hiv and [hepatitis c], and sharing syringes provides a direct route of transmission for diseases.”35 intravenous drug use is the most common means of hepatitis c transmission in the united states.36 fully, one-third of people ages 18 to 30 who inject drugs are hepatitis c-positive.37 intravenous drug use is attributable to thousands of new diagnoses of hiv infection each year.38 in 2017, marion county saw a “10-fold increase” in new hepatitis c cases.39 of those cases, 86% 32. id. 33. human rights watch, supra note 24. 34. id. 35. access to clean syringes, ctr. for disease control & prevention, https://www.cdc. gov/policy/hst/hi5/cleansyringes/index.html [https://perma.cc/y9gy-e8zr] (last updated aug. 5, 2016). 36. id. 37. id. 38. id. 39. kelly reinke, syringe exchange program distributed throughout marion county, cbs4 (nov. 11, 2019), https://cbs4indy.com/2019/11/11/syringe-exchange-program-distributedthroughout-marion-county/ [https://perma.cc/txq8-ayxe]. 2021] safer is better 221 were found to be directly related to intravenous drug use.40 stigmatizing the illness does not work; you cannot shame people sober. criminalization does not work; imposing fines and jail time does not, largely, help substance use disorder sufferers gain access to quality long-term health care and treatment. what these traditional public policies and legal responses have done, mostly, is relegate these individuals to the shadows. there, they are dying. alone. and, they are dying preventable deaths. it does not have to be this way, nor should it. b. data on the economic impact for those unconvinced or unmoved by the human toll, the economic impacts associated with untreated substance use disorders, and particularly, with overdose deaths related to the disease, are incontrovertible. the national opioid epidemic has cost $2.5 trillion in only four years.41 the council of economic advisors to the president (“cea”) issued a staggering report detailing extensive economic costs being experienced across the country.42 in constructing its report, the cea took into account the elevated health care costs, sacrificed contributions to the economy through stable employment, and elevated criminal justice costs due to the opioid drug problem.43 such elevated costs are measurable, as shown by the centers for disease control and prevention’s statistics. the lifetime cost of hiv treatment is estimated, at the 2010 inflation rate, to be $379,668 per patient.44 initially, hepatitis c treatment ranged from $84,000 to $96,000 per person in 2014.45 since 2014, the cost of hepatitis c-curing medication has fallen to roughly $40,000 for medicaid program recipients.46 some private insurers have been able to negotiate even greater reductions in these drug prices. treating those infected with hepatitis c can save an estimated $14.3 billion in long-term health costs associated with the disease. however, the prohibitive cost of the medication means that treatment for all individuals currently hepatitis c-positive comes with a $69.5 billion price tag. this has led insurance companies to restrict access to life-saving drugs and has been particularly challenging for medicaid and other government programs 40. id. 41. the council of econ. advisors, the full cost of the opioid crisis: $2.5 trillion over four years, white house (oct. 28, 2019), https://www.whitehouse.gov/articles/full-cost-opioidcrisis-2-5-trillion-four-years/ [https://perma.cc/8jmv-6vc6]. 42. the council of econ. advisors, the underestimated cost of the opioid crisis, white house (nov. 2017), https://www.whitehouse.gov/sites/whitehouse.gov/files/images/the%20 underestimated%20cost%20of%20the%20opioid%20crisis.pdf [https://perma.cc/2xss-wfrz] [hereinafter underestimated cost]. 43. id. 44. access to clean syringes, supra note 35. 45. id. 46. id. 222 indiana health law review [vol. 18:215 to fund.47 while the cea agrees that the costs of substance use disorder’s nonfatal consequences certainly negatively impact the economy, it estimates that the costs relating to premature deaths from drug overdoses are vastly more consequential and broadly under-accounted for.48 the cea estimates these costs as the value of a statistical life (“vsl”),49 and it found that, in 2015 alone, opioid-involved overdose deaths accounted for an age-adjusted median cost of $431.7 billion.50 to put this in perspective, the cea’s estimate for total costs related to the opioid epidemic, factoring in both nonfatal opioid misuse and accidental opioid overdose fatalities, cost $504 billion – meaning the costs of opioid-related deaths far outnumbered those costs factored under the umbrella of nonfatal opioid misuse consequences.51 again, this gives policymakers a clear, measurable, and collective goal: reduce accidental overdose deaths. c. harm reduction as a primary strategy while there is no single definition of harm reduction, the term refers to a collection of activities aimed at reducing harm and death among those with substance use disorder and is premised on values of public health and human rights. general tenets of the movement focus on (1) respecting the rights of people who use drugs; (2) relying on evidence-based public health solutions to address substance use disorder; (3) retaining a commitment to social justice by creating networks of resources for people who use drugs; and (4) avoiding stigma when addressing and working with individuals with substance use disorder.52 harm reduction, as a drug policy strategy, is broadly underutilized compared to the more traditional mitigation efforts. in a 2018 survey conducted by the new york times, thirty experts in the field – ranging from policymakers to drugtreatment specialists to public safety workers – were given a hypothetical in which they had $100 billion over five years to spend on addressing the opioid epidemic.53 of those experts, only four prioritized harm reduction strategies ahead of other strategies.54 despite this, the experts overall earmarked an average of 2% of their total funding dollars for a little-known subcategory within the harm reduction penumbra: safe consumption sites.55 47. id. 48. underestimated cost, supra note 42, at 2-3. 49. id. at 3. 50. id. at 6. 51. id. at 8. 52. what is harm reduction?, harm reduction int’l, https://www.hri.global/what-isharm-reduction [https://perma.cc/4kl8-3nak] (last visited july 25, 2020). 53. josh katz, how a police chief, a governor and a sociologist would spend $100 billion to solve the opioid crisis, n.y. times (feb. 14, 2018), https://www.nytimes.com/interactive/ 2018/02/14/upshot/opioid-crisis-solutions.html [https://perma.cc/aa9w-2v9l]. 54. id. 55. id. 2021] safer is better 223 iii. safe consumption sites a. the basics alternatively known under multiple monikers, including supervised consumption sites, safe-injection sites, safe-injection facilities, or community health engagement locations, a safe consumption site is a facility where individuals with substance use disorders can come to use safely, with medical staff at the ready to assist them if something goes wrong – such as an accidental overdose or unintentional fentanyl exposure.56 facilities provide a space for individuals to bring already-purchased illicit drugs and use them with sterile equipment. such facilities also often provide additional supplies and resources such as fentanyl-testing kits, take-home syringes to reduce shared needle use (akin to syringe exchange programs), and connecting individuals to needed social services and drug treatment referrals.57 safe consumption sites have been widely utilized in europe for decades,58 and there are currently about 120 sites in ten countries worldwide.59 in that time, various measures have shown that safe consumption sites reduce the risk of disease transmission by providing sterile equipment that was properly disposed of after a single-use, encouraging safer use outside of the clinic, reversing thousands of drug overdoses, connecting individuals with needed clinical services like wound care or sexually transmitted infection screening, and providing access to social resources and drug treatment services.60 the fact that these sites had a measurable impact on the public health of the communities in which they opened can be seen by comparing before and after statistics. in the late 1990s, canada was beginning to explore whether safe consumption sites, already in implementation in european countries, could help address substance use morbidities and mortalities in the country. the vancouver injection drug user study, implemented in 1996, attempted to examine substance use practices in the vancouver area to get a snapshot of the public health impact.61 their findings were instructive. 56. what is an scs?, yes to scs, https://www.yestoscs.org/whatisanscs [https://perma.cc/ tpu6-24kj] (last visited july 25, 2020). 57. beau kilmer et al., considering heroin-assisted treatment and supervised drug consumption sites in the united states 5 (2018). 58. id. 59. supervised consumption sites, drug pol’y alliance, http://www.drugpolicy.org/ issues/supervised-consumption-services [https://perma.cc/y36a-rwrj] (last visited july 25, 2020). 60. id. these specific observations were based on data from insite, the vancouver scs that opened in 2003. though, similar results have been reported in a host of other studies and articles from sites in europe and australia. 61. evan wood et al., unsafe injection practices in a cohort of injection drug users in vancouver: could safer injecting rooms help?, 165 canadian med. ass’n j. 405, 406 (2001). 224 indiana health law review [vol. 18:215 of 776 respondents, 214 or 27.6% reported sharing, borrowing, or lending needles within the previous six months.62 although hiv-positive respondents were less likely overall to engage in shared needle use, more than 20% of them disturbingly still shared needles for lack of access to sterile injection equipment.63 of the same respondents, 13.7% reported routinely injecting drugs in public.64 startlingly, 581 respondents – 74.9% – reported injecting alone at least once.65 intuitively, injecting illicit drugs alone is one of the most dangerous substance use practices because it all-but ensures death in the event of an overdose. all of these findings were in spite of vancouver’s implementation of a syringe exchange program, leading study authors to conclude that having a more substantial impact on these numbers would require “the establishment of supervised safer injecting rooms.”66 these findings were published in 2001.67 in 2003, vancouver opened canada’s first safe consumption site, insite.68 early studies evaluating the efficacy of the vancouver site delivered promising results. from december 2003 to june 2004, the vancouver injection drug users study interviewed 431 injection drug users and found that only 11.4% reported using shared needles within the previous six months.69 of the same population of respondents, those that used the new facility were 70% less likely to share needles.70 another study found that hiv-positive individuals’ likelihood of sharing needles had decreased from over 20% in a pre-insite study to 16.5% in a post-insite study.71 additionally, the vancouver community at large benefited from the safe injection practice education that more than one-third or 33.5% of insite users received from may 2003 to october 2004.72 this additional public health resource, outside of the provision of strictly substance use services, illustrates the broad impact that safe consumption sites can have through community training, public health education, and referral resources. these early evaluations appear to be standing up to the test of time. as of the end of 2018, insite has had 3.6 million visits from individuals wishing to inject illicit drugs under supervision, 48,798 clinical treatment visits, and 6,440 62. id. 63. id. at 407. 64. id. 65. id. 66. id. at 409. 67. id. at 405. 68. ian bailey, the inside story of vancouver’s safe injection site, globe & mail (oct. 6, 2007), https://www.theglobeandmail.com/news/national/the-inside-story-of-vancouvers-safeinjection-site/article18146473/ [https://perma.cc/e9wm-r8r7]. 69. thomas kerr et al., safer injection facility use and syringe sharing in injection drug users, 366 lancet 316, 316 (2005). 70. id. 71. evan wood et al., factors associated with syringe sharing among users of a medically supervised safer injecting facility, 1 am. j. infectious diseases 50, 52 (2005). 72. see evan wood et al., safer injecting education for hiv prevention within a medically supervised safer injecting facility, 16 int’l j. drug pol’y 281, 282 (2005). 2021] safer is better 225 overdose interventions without any deaths.73 in 2018 alone, there were 189,837 visits by 5,436 individuals.74 also, there were 1,466 overdose interventions, 3,725 clinical treatment interventions such as wound care or pregnancy tests, and 443 client admissions to onsite, the adjoining detox treatment facility where individuals had an average stay of 11 days.75 b. safe consumption in the united states currently, no sanctioned safe consumption sites exist in the united states, owing to the federal government’s interpretation of the pejoratively-termed crack house statute of the controlled substances act.76 this code section prohibits the establishment of properties that will allow drug use on the premises of a house or building.77 proponents argue that this legislation was aimed at combatting the establishment of drug houses, not medical facilities.78 an unsanctioned, underground safe consumption site has been operational in the united states in an undisclosed, urban area since 2014.79 the site is open five days per week for four to six hours per day and is accessible via invitation only.80 no more than sixty people are permitted to have carrying privileges, which is card-carrying access to the site, at any given time.81 between 2014 and 2019, over 10,514 injections were carried out with only thirty-three overdoses, all of which were successfully reversed.82 moreover, in a survey taken by each patient before injection, 67.4% of the visitors at this site self-reported that they had disposed of used syringes unsafely in the past thirty days.83 because safe consumption sites dispose of all paraphernalia on-site, this facility alone prevented roughly 1,725 unsafe public 73. insite user statistics, vancouver coastal health, http://www.vch.ca/publichealth/harm-reduction/supervised-consumption-sites/insite-user-statistics [https://perma.cc/ej968n2m] (last updated july 2019). 74. id. 75. id. 76. see alex kreit, safe injection sites and the federal “crack house” statute, 60 b.c. l. rev. 414 (2019). 77. 21 u.s.c. § 856 (2020). 78. nina feldman, ‘crackhouse’ or ‘safehouse’? u.s. officials try to block philly’s supervised injection site, kaiser health news (sep. 9, 2019), https://khn.org/news/crackhouseor-safehouse-u-s-officials-try-to-block-phillys-supervised-injection-site/ [https://perma.cc/97spmrm4]. 79. alex h. kral & peter j. davidson, addressing the nation’s opioid epidemic: lessons from an unsanctioned supervised injection site in the u.s., 56 am. j. preventative med. 919, 919 (2017). 80. id. at 920. 81. id. 82. alex h. kral et al., evaluation of an unsanctioned safe consumption site in the united states, 383 new eng. j. med. 589, 589 (2020). 83. kral & davidson, supra note 79, at 921. 226 indiana health law review [vol. 18:215 disposals of syringes or 67.4% of the 2,574 different injections over two years.84 in addition, the facility prevented over 90% of public injections, which would have otherwise occurred in a public bathroom or on a street,85 thus causing significant positive externalities for the public at large by preventing thousands of cases of public injections and potential police arrests. while, at the time of this writing, no legally sanctioned safe consumption site has been opened in the united states, there is little doubt that they are coming. officials from more than a dozen cities, counties, and states have started to actively study and discuss safe consumption sites as potential public health intervention tools in their jurisdictions.86 seattle was the first city to approve plans to begin to lay the groundwork for the establishment of a safe consumption site in 2017. legislation to enable the establishment of a site has been passed in san francisco, philadelphia, ithaca, and new york city.87 still, other legislative measures in additional states and counties have been introduced or are at least in the early stages and beginning to assign investigative committees to research the efficacy and feasibility of safe consumption sites.88 while seattle was an early pioneer in the push to introduce sanctioned safe consumption sites, policymakers and public health officials quickly faced a wave of pushback as surrounding towns rapidly introduced legislation to ban the establishment of a site in their neighborhoods. a widely-circulated opposition petition gained nearly 50,000 signatures in the seattle-metro area alone.89 the petition was dismissed by the courts, but the political controversy has forced proponents to compromise on a physical location by instead proposing a mobile site.90 ongoing tension and pushback have significantly stalled the city’s early gains and rapid progress.91 instead, policymakers’ and public health proponents’ attention has increasingly turned to philadelphia. safehouse, a philadelphia nonprofit, moved forward with plans to open a brick and mortar site after city officials signaled their support.92 the federal department of justice vowed to fight any attempts to establish safe consumption sites in the united states93 and made good on that promise by suing safehouse in 84. id. at 920. 85. id. 86. azeen ghorayshi, the feds say safe injection sites are illegal. here are all the places considering them anyway., buzzfeed news (sept. 6, 2018), https://www.buzzfeednews.com/ article/azeenghorayshi/safe-injection-site-proposals-map [https://perma.cc/8mr5-4hdh]. 87. id. 88. id. 89. id. 90. id. 91. id. 92. office of the mayor, mayor kenney issues statement on overdose prevention sites, city phila. (apr. 18, 2019), https://www.phila.gov/2019-04-18-mayor-kenney-issues-statement-onoverdose-prevention-sites/ [https://perma.cc/lh67-n99a]. 93. rod j. rosenstein, fight drug abuse, don’t subsidize it, n.y. times (aug. 27, 2018), 2021] safer is better 227 federal court last year.94 the government’s civil suit sought declaratory judgment that the establishment of a safe consumption site would violate section 856 of the controlled substances act.95 c. recent developments in early october of last year, public health advocates and safe consumption site proponents won their first legal battle regarding the legality of the sites. a district court held that section 856 of the controlled substances act did not apply to safehouse’s proposed site because the nonprofit’s goal is “to reduce drug use, not facilitate it.”96 judge mchugh reiterated that the congressional intent in enacting section 856 was to outlaw drug houses, not medical treatment facilities.97 the legal battle to establish the first safe consumption site in the united states will continue, as the federal government has guaranteed it will appeal the decision in united states v. safehouse98 and vigorously fight any other city’s similar attempts to open a site.99 in a letter to safehouse attorney ilana eisenstein, u.s. attorney william mcswain cautioned that an opening of the site prior to exhaustion of the appeals process would, “force [his] hand, and [he would] have no choice but to take the steps necessary to maintain the status quo.”100 listed among possible options included drug seizures, arrests for site users and staff, and criminal forfeiture proceedings.101 similarly, pushback from residents of kensington, the neighborhood marked for the establishment of safehouse’s first physical site, has galvanized opponents.102 after plans for the location of the site were revealed, legislation was introduced by some on the city council to change the zoning ordinance of the https://www.nytimes.com/2018/08 /27 /opin ion /opioids-heroin-injection-sites.html [https://perma.cc/pyg7-4buk]. 94. see united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019). 95. see complaint for declaratory judgment, united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019) (no. 2:19-cv-00519), 2019 wl 462760. 96. safehouse, 408 f. supp. 3d at 618. 97. id. at 595. 98. id. at 618. 99. press release, jeffrey a. rosen, statement from deputy att’y gen. jeffrey a. rosen on the united states v. safehouse ruling (oct. 2, 2019), https://www.justice.gov/ opa/pr/statementdeputy-attorney-general-jeffrey-rosen-united-states-v-safehouse-ruling [https://perma.cc/6ct7vx6f]. 100. jeremy roebuck & aubrey whelan, u.s. attorney threatens to close philly supervised injection site if it opens before appeals courts weigh in, phila. inquirer, https://www. inquirer.com/health/opioid-addiction/supervised-injection-site-philly-safehouse-appeal-mcswainmchugh-goldfein-20191015.html [https://perma.cc/5p3u-jth5] (last updated oct. 15, 2019). 101. id. 102. jake blumgart, kensington neighbors dismayed by ruling on supervised injection site, whyy (oct. 2, 2019), https://whyy.org/articles/kensington-neighbors-dismayed-by-ruling-onsupervised-injection-site/ [https://perma.cc/zuk9-6cr8]. 228 indiana health law review [vol. 18:215 planned location from industrial-commercial to single-family residential to prevent a safe consumption site from being able to open there.103 such moves illustrate the uphill nature of realizing the establishment of the first safe consumption site in the united states: community attitudes and perceptions towards people with substance use disorders, lack of education regarding evidence-based harm reduction, and fears regarding public health and safety. however, the ruling in philadelphia sets an important precedent for other cities looking for innovative and evidence-based harm reduction tools, like the creation of safe consumption sites, to combat drug-related morbidity and mortality in their communities. as with almost every facet of our normal day-to-day existence, the emergence of the covid-19 global public health crisis has impacted the national conversation and consciousness regarding safe consumption sites. in one vein, the pandemic has contributed to the stalling of the opening of safehouse’s safe consumption site. the same judge who found in safehouse’s favor at the trial court level granted the government’s requested stay of these final orders, citing the upheaval related to the pandemic and ongoing social justice movement with regards to the killing of george floyd by police.104 these issues, judge mchugh wrote, “make this the wrong moment for another change in the status quo.”105 despite this move, judge mchugh was abundantly explicit in his reasoning: that a stay was in the public interest, nearly exclusively, because of the unprecedented ongoing national tribulations.106 specifically, judge mchugh wrote that [a]ll change results in some level of disruption, and philadelphia has already experienced two profound disruptions. it is confronted with a public health crisis even larger than the opioid epidemic, which has strained municipal government and individual citizens to an unprecedented degree, imposing extreme demands on the city's resources and employees. at the same time revenues have dwindled because of the deep downturn in economic activity. the nerves of citizens are frayed by fear and uncertainty, and that was true before the death of mr. floyd and the widespread protests that arose in its aftermath. the opening of safehouse would require multiple public meetings, the time and attention of the city health department, and the allocation of police resources. even if one assumes a flawless opening process, the operation of safehouse would represent a significant change in how the city responds to opioid abuse, and such change would necessarily be 103. id. 104. see united states v. safehouse, no. 2:19-cv-00519, 2020 wl 3447775 (e.d. pa june 24, 2020). 105. id. at *1. 106. id. 2021] safer is better 229 disruptive.107 despite this ultimate conclusion, judge mchugh said that the government had not made any showing that (1) the opening of the site would frustrate any congressional purpose,108 (2) the opening of the site would lead to riskier or increased drug use,109 (3) any tangible harm would be caused by opening the site without the full support of local and other government actors,110 or (4) the surrounding community would be harmed absent the stay.111 on the other hand, the ongoing covid-19 crisis has led to a flurry of advocacy by public health professionals, medical experts, and attorneys who are gravely concerned about the enhanced negative impacts of the pandemic on the community of people living with substance use disorders. for this population, which already has suppressed access to health care, ongoing medication-assisted treatment and other services provided or referred by harm reduction programs are impacted by quarantining and social distancing requirements.112 increasingly, people are touting the necessity of these sites to help the population with substance use disorders, especially during the pandemic.113 people with substance use disorders cannot quarantine without proper access to resources like medication-assisted treatment; in many instances, they cannot social distance. these facilities can support them through this time, and they can also better protect the community at large by providing covid-19 screening and testing for site participants.114 as a result, california legislation allowing safe consumption sites is back for reconsideration, more than a year after it had been abandoned after passing but being vetoed by then-governor jerry brown.115 assembly bill 362 would allow for the legal establishment of a safe consumption site in the san francisco area.116 california legislators cite the pandemic for inspiring renewed focus on the issue. “during c[ovid]-19, the last thing we should be doing is shuffling people who use drugs into jails or waiting until an overdose sends them to the emergency 107. id. at *13. 108. id. at *5. 109. id. at *6. 110. id. at *8. 111. id. 112. julian mark, colliding epidemics: need for ‘safe consumption sites’ more dire in covid era, scientists and lawmakers say, mission loc. (july 20, 2020), https://missionlocal.org/ 2020/07/colliding-epidemics-need-for-safe-consumtion-sites-more-dire-in-covid-era-scientists-andlawmakers-say/ [https://perma.cc/ltb2-5xwg]. 113. jeffrey a. singer, safe injection sites: coronavirus underlines why they make sense, cato inst. (mar. 17, 2020), https://www.cato.org/publications/commentary/safe-injection-sitescoronavirus-underlines-why-they-make-sense [https://perma.cc/2tdq-upgb]. 114. id. 115. mark, supra note 112. 116. id. 230 indiana health law review [vol. 18:215 room,” one lawmaker said.117 this promising turn is further emphasized by a recent amicus brief, signed by nine attorneys general across the country, supporting the safehouse site in philadelphia.118 this brief stresses the traditional state role as the arbiter of public health and safety, and it emphasizes a state’s right to respond to its unique public health challenges with “cutting-edge medical interventions.”119 it also calls into question the federal government’s interpretation of section 856 of the controlled substances act, saying it invokes a constitutional question regarding states’ police powers – among which is the right of the state to regulate the practice of medicine within its borders.120 as california lawmakers and state attorneys general across the nation show us, and precisely because of the novel nature of the ongoing challenges the pandemic and other national issues have presented us with, the time is ripe for indepth study and policy work on how safe consumption sites can be implemented in jurisdictions across the country. indiana must have a place in the emerging national discourse regarding harm reduction through safe consumption sites. iv. the path forward for a safe consumption site in indiana indiana gained national and global notoriety in the worst way possible as the state became a case study on how not to react to a public health crisis.121 the outbreak of hiv and hepatitis c in rural scott county, driven by shared use of needles for intravenous drug use, was a devastating portrait of what can happen when policymakers turn a blind eye to evidence-based science.122 for decades, indiana lawmakers had been staunchly opposed to syringe exchange programs, initiatives that were long-proven to be effective at reducing disease transmission related to intravenous drug use by providing people with substance use disorders with clean syringes.123 a historically conservative state, indiana made the establishment of syringe exchange programs illegal under state law.124 the scott county epidemic 117. id. 118. see brief for d.c. et al. as amici curiae in support of brief for appellee safehouse & affirmance, united states. v. safehouse, no. 20-1422 (3d cir. july 6, 2020). 119. id. 120. id. 121. heather boerner, mapping how the opioid epidemic sparked an hiv outbreak, wfyi indianapolis (jan. 14, 2018), https://www.npr.org/sections/health-shots/2018/01/14/577713525/ mapping-how-the-opioid-epidemic-sparked-an-hiv-outbreak [https://perma.cc/9gdt-qaqv]. 122. issie lapowsky, indiana, reeling from opioid crisis, arms officials with data, wired (sept. 14, 2017), https://www.wired.com/story/indiana-reeling-from-opioid-crisis-arms-officialswith-data/ [https://perma.cc/de9m-w6vh]. 123. austin frakt, politics are tricky but science is clear: needle exchanges work, n.y. times (sept. 5, 2016), https://www.nytimes.com/2016/09/05/upshot/politics-are-tricky-but-scienceis-clear-needle-exchanges-work.html [https://perma.cc/3ssq-2bxf]. 124. nicholas golding, the needle and the damage done, 14 ind. health l. rev. 173, 189 2021] safer is better 231 ultimately led ultra-conservative, then-governor mike pence to lift the state ban on exchange programs, but not until a few hundred cases had cropped up in the small community.125 many hoosiers still hold pence’s and other indiana lawmakers’ feet-dragging, with regard to allowing syringe exchange programs in indiana, accountable for a preventable outbreak. in the years since, a majority of indiana lawmakers have been increasingly receptive to the public health and evidence-based science regarding syringe exchange programs, and they have passed legislation to allow for increased access to such programs.126 in 2017, the republican-held state senate voted 32-16 to expand syringe exchange programs by allowing local governments to initiate their own programs without state authorization and removing the requirement that the state health commissioner declare a public health emergency before a syringe exchange program could be established.127 the bill was then signed into law by governor eric holcomb.128 since that time, several counties, including marion county, have successfully piloted syringe exchange programs.129 this shift is an excellent first step in the use of harm reduction strategies. the next step is to contemplate a path forward for the establishment of a pilot safe consumption site. a. the indiana code despite the progressive, evidence-based changes indiana lawmakers have made in recent years with regards to public health and the fight to mitigate the effects of substance use disorder in indiana, installation of a safe consumption site will still require an overhaul of indiana drug law, tweaks to local law for those jurisdictions pursuing the installation of a site, and a well-designed and clearly articulated advocacy strategy to build a coalition of support between policymakers, public health and safety professionals, and residents. (2015). 125. paul demko, how pence's slow walk on needle exchange helped propel indiana's health crisis, politico (aug. 7, 2016), https://www.politico.com/story/2016/08/under-pencesleadership-response-to-heroin-epidemic-criticized-as-ineffective-226759 [https://perma.cc/pf9xfwcn]. 126. brandon smith, house approves syringe exchange bill, sends it to senate, wfyi indianapolis (jan. 31, 2017), https://www.wfyi.org/news/articles/house-approves-syringeexchange-bill-sends-it-to-senate [https://perma.cc/yyv5-9a3c]. 127. h.b. 1438, 120th gen. assemb., 1st reg. sess. (ind. 2017). 128. associated press, indiana gov. holcomb signs pre-k expansion, needle exchange bills, chi. trib. (apr. 26, 2017), https://www.chicagotribune.com/suburbs/post-tribune/ct-indianaholcomb-signs-bills-20170426-story.html [https://perma.cc/t9k6-t52l]. 129. syringe service program providing counties, in.gov (july 18, 2018), https://www.in. gov/isdh/files/ssp%20map%20-%20july%202018-ec.pdf [https://perma.cc/sl3q-wb37] (showing that madison and lawrence counties enacted seps, but have since terminated or failed to renew them). 232 indiana health law review [vol. 18:215 1. indiana drug laws indiana drug law outlines a 5-schedule scheme in which controlled substances are categorized based on their potential for abuse balanced against their potential medicinal benefit.130 drugs with the highest potential for abuse and the lowest recognized benefit are determined to be schedule i drugs and carry the highest associated penalties for possession, distribution, and more.131 schedule v drugs, inversely, are judged to have a low likelihood of abuse and invoke lesser penalties.132 possession of any substances classified in schedules i through iv without a valid prescription is criminalized and can incur a class a misdemeanor in indiana.133 additionally, penalties apply if there is an enhancing circumstance that can elevate the charge to a level 6 felony.134 moreover, heightened penalties apply to possession of either cocaine or a narcotic.135 this presents a problem for the establishment of safe consumption sites. the premise of the sites is that all materials for supervised use would be provided – including syringes, stoppers, sterile gauze, alcohol pads, tourniquets, and bandages. these are all materials except for the controlled substances themselves, which would be provided by the site users. therefore, these users must necessarily possess the controlled substances in transit to the site. most drugs used at the site would likely be either cocaine or a narcotic, such as heroin, and, therefore, subject to more stringent drug prosecution. at the very least, those found in possession of either substance could immediately be charged with a level 6 felony, with increasing severity as the amount possessed increases.136 this criminalization would make access to the site incredibly difficult and risky for individuals because the mere transit to the site would be classified as a criminal endeavor. administrators of indiana’s syringe exchange program faced a similar dilemma. though the program was allowed to be initiated, even expanded possession of a syringe was – and still is – a level 6 felony in indiana.137 for site users, this made traveling to and visiting the site, where they were expected to return with used needles in exchange for sterile ones, incredibly risky. if site users were stopped and searched by police, they were subject to the state’s possession penalties, regardless of the fact that they were attempting to engage in a lawful public health outreach program. this has made individuals with substance use disorder extremely wary of engaging with the sites and has dampened the positive effects and wide reach the programs could have but for the continued 130. drug schedules 1-5, in.gov, https://www.in.gov/isdh/27380.htm [https://perma.cc/49ghd2zl] (last visited oct. 18, 2020). 131. id. 132. id. 133. ind. code § 35-48-4-7 (2020). 134. ind. code § 35-48-1-16.5 (2020). 135. ind. code § 35-48-4-6 (2020). 136. id. 137. ind. code § 16-42-19-18 (2020). 2021] safer is better 233 criminalization of syringe possession. to attempt to reconcile this contradiction, some indiana counties have opted for an identification card of sorts.138 essentially, the cards have an identification number that cannot be used to personally identify a program participant, as that violates state law,139 but can verify that the individual is a program participant.140 law enforcement officers are encouraged to use their own discretion and may still initiate arrests for syringe possession, but possession of the card, ideally, may encourage the officer to show leniency.141 additionally, many of the cards have the posted hours of operation for when the local syringe exchange program is accessible, helping an officer further discern the context of possession and determine whether the individual is in transit to the facility or is merely in possession of a syringe for purposes unrelated to the use of a public health program.142 while the ideal solution and goal would be to decriminalize possession of a syringe to allow individuals with substance use disorders unfettered access to harm reduction programs, a feasible first step is to implement broad card-carrying provisions that are recognized across county lines. this way, those actively seeking cleaner, safer instruments can come out of the shadows, use safely, and have fewer morbidities associated with intravenous drug use. these concepts can and must be applied to safe consumption sites too if they are to be successful. while site visitors coming to a safe consumption site may be less concerned with the state’s laws governing possession of syringes and other paraphernalia because these materials would be lawfully provided by the site administrators, the criminal consequences for possession of a controlled substance is a big hurdle. it carries the potential for significant criminal penalties and directly burdens access to the harm reduction resources offered by the sites. similar to some of the solutions proposed by the syringe exchange administrators, safe consumption site advocates could propose that site visitors be provided with non-identifying, participation cards that they could carry to provide an officer in the event of a stop and search. these cards would identify them as users of the site and, as such, participants in the lawful public health harm reduction program. additionally, the absence of 138. ja’nel johnson, how the scott county, indiana, needle exchange program works, 89.3 wfpl (apr. 22, 2015), https://wfpl.org/scott-county-indiana-needle-exchange-program-works/ [https://perma.cc/u7r8-443z]. 139. ind. state dep’t of health, indiana state department of health syringe services & harm reduction program manual for local health departments version 3.0, in.gov 19 (sept. 2017), https://www.in.gov/isdh/files/guidance%20document%20-%202017%20update%20-%209-12-17ec.pdf [https://perma.cc/v57j-jpn3]. 140. johnson, supra note 138. 141. aprile rickert, with a needle exchange, how do clark county officials enforce syringe laws?, news & trib. (aug. 14, 2017), https://www.newsandtribune.com/news/with-a-needleexchange-how-do-clark-county-officials-enforce/article_307bd15c-7f90-11e7-8785bf5213a653ab.html [https://perma.cc/ev3h-4jyl]. 142. ind. code § 35-48-1-16.5 (2020). 234 indiana health law review [vol. 18:215 additional paraphernalia could indicate the individual’s intent to use at the site, under medical supervision and with the site’s sterile equipment. additional context, such as prominently listed site locations and hours, could further help an officer discern the context of the possession. 2. indiana public health laws additionally, an enabling statute along the lines of indiana’s syringe exchange program law,143 as amended per house enrolled act 1438,144 would likely be necessary to empower municipalities to begin even the earliest planning stages for a pilot safe consumption site. many provisions of the law are sound and could likely be, quite literally, copied and pasted into an indiana safe consumption site law. for example, section 6’s duties for the syringe exchange program could easily be transcribed into a safe consumption site enabling statute. these duties include, inter alia, provisions that the sites be registered with both the state and local health departments, have program administration overseen by a licensed medical professional, properly dispose of syringes and other paraphernalia, and that no personally identifiable information be collected or recorded at the site.145 however, there are several areas of concern to think through before the drafting of an enabling statute for safe consumption sites begins. to start, even as recently amended to allow more flexibility and autonomy at the local level, the enabling statute, with regards to syringe exchange programs, still remains too rigid of a framework for safe consumption sites to operate successfully within. as such, there would need to be key differences in the drafting of the two laws. for example, the law allows syringe exchange programs to remain in effect for up to two years, and then, either be renewed for another two-year period or be terminated.146 this two-year timeline is too accelerated for adequate creation, installation, and administration of a site with time allowed to begin to evaluate the program’s efficacy. madison weintraut, the current program manager for marion county’s syringe access program, emphasized the grueling timeline she had to work with to get marion county’s first syringe program off the ground. first came the extensive and protracted grassroots campaign to get local lawmakers and community stakeholders on board with creating the program. then came a strenuous lobbying effort to get authorizing legislation passed. once passed, she and her team had to identify funding since, by law, no state or federal funds may be used for the purchase of syringes.147 after that, they had to (1) designate a site – a difficult task, (2) create and stock mobile units, (3) staff and deploy units in the community, (4) gain the trust of the substance use disorder community to get 143. ind. code § 16-41-7.5 (2020). 144. h.b. 1438, 120th gen. assemb., 1st reg. sess. (ind. 2017). 145. ind. code § 16-41-7.5-6 (2020). 146. see ind. code § 16-41-7.5-11 (2020). 147. ind. state dep’t of health, supra note 139. 2021] safer is better 235 them to engage with the program, and finally (5) wholly administer the program. after all of that, she then had to attempt to collect program data and evaluate the early results of the program.148 thus, while all the practical steps of designing, implementing, administering, and evaluating the program are ongoing, vigorous lobbying for renewal has to be taking place simultaneously. this is a nearly impossible framework within which syringe exchange programs must work. the logistical demands of establishing a safe consumption site, coupled with their novelty and politically controversial nature, mean a two-year renewal provision would almost certainly doom a pilot site. i propose that no renewal period be added to an enabling statute, but rather that the language allows for termination of a program at the evidence-based discretion of the local public health authority in the municipality in which it operates. for example, dr. virginia caine, director of the marion county public health department, would be allowed to determine renewals in marion county based on the data compiled by a harm reduction task force or other committee charged with collecting and evaluating the efficacy of the sites and general overdose or disease transmission rates in marion county. indiana lawmakers could also look to the roadmap drawn by the proposed local ordinance for a safe consumption site ( “overdose prevention program”) out of california.149 this ordinance develops oversight authority and regulatory enforcement power, placing it in the hands of the department of health,150 as recommended above. additionally, it outlines a permit process, creates operating standards, provides for inspections, imposes reporting requirements, and enumerates permit revocation processes and other penalties for noncompliance.151 finally, the ordinance affirmatively calls for law enforcement to “deprioritize enforcement of laws prohibiting possession of illegal drugs and drug paraphernalia against those individuals . . . access[ing] an overdose prevention program,” allowing for these individuals to more freely access the public health resource without fear of immediate criminalization.152 allowing for local policymakers and public health officials to narrowly study substance use in their communities, and providing them with the autonomy to enact, expand, reduce, or terminate programs based on their knowledgeable assessment of the need, makes for better and more receptive policymaking at the local level. it also alleviates the political pressures safe consumption site administrators have to face. this way, they can more squarely focus on administering a desperately needed public health service. 148. madison weintraut, program manager, marion cty. syringe access program, presentation to the indiana university robert h. mckinney school of law opioid litigation seminar class (aug. 5, 2019) (notes on file with the author). 149. s.f., cal., ordinance 105-20 (aug. 10, 2020). 150. id. 151. id. 152. id. 236 indiana health law review [vol. 18:215 b. local law and the hurdle of home rule opponents of safe consumption sites have a wealth of tools at their disposal to block the establishment of a site. one universal favorite is to use preemptory zoning legislation to prevent physical sites from being established. such are colloquially known as not-in-my-back-yard (“nimby”) laws. after the location of the planned safehouse site in philadelphia became public, a city-county councilman introduced legislation – which passed – to convert the proposed space from industrial-commercial to single-family residential. this effectively prevented safehouse from being able to open at that site.153 for good measure, the city-county council approved the lease of the site to another entity the day before the safehouse decision came down.154 to further assail the possibility that safehouse will be able to open its planned safe consumption site, a state senator proposed legislation to preempt localities from being able to open safe consumption sites.155 this is a common exercise across the country in a variety of matters, even those outside the scope of public health law, when more conservative state governments are confronted with more progressive municipalities. indiana exemplifies this tension perfectly. popularly termed home rule acts are supposed to grant local leaders greater flexibility, enable increased responsiveness, and foster innovative policymaking for unique challenges.156 indiana’s home rule act of 1980, oxymoronically, enumerates a long list of restrictions.157 state lawmakers have used it to prevent local lawmakers from setting local minimum wages, regulating housing, regulating worker schedules, and implementing environmental initiatives – like outlawing plastic bags, as other municipalities have done.158 there is also a significant trend in the passing of aggressive state preemption laws when localities attempt to institute innovative public health laws.159 it is conceivable that a similar move to preempt the establishment of a pilot safe consumption site in indiana would be introduced and likely passed. 153. blumgart, supra note 102. 154. id. 155. elizabeth hardison, williams says supervised injection sites aren’t the answer to fighting drug use. so he wants to ban them, phila. trib. (oct. 3, 2019), https://www.phillytrib. com/news/local_news/williams-says-supervised-in jection-sites-aren-t-the-answerto/article_c282e1a6-7b64-5b11-9a01-067e74e0c46f.html [https://perma.cc/z3ez-bwjw]. 156. samuel b. stone, home rule in the midwest, ind. univ. pub. pol’y inst. 1 (july 2010), http://ppidb.iu.edu/uploads/publicationfiles/pc_hmrules_web.pdf [https://perma.cc/g6czc2tz]. 157. joshua claybourn, in defense of hoosier home rule, indystar (may 7, 2017), https://www.indystar.com/story/opinion/2017/05/07/claybourn-defense-hoosier-homerule/101289696/ [https://perma.cc/8ua8-enlt]. 158. id. 159. see lori riverstone-newell, the rise of state preemption laws in response to local policy innovation, 47 publius 403 (2017). 2021] safer is better 237 the indiana legislature’s aggressive use of preemptive action, coupled with the overwhelmingly conservative make-up of this legislative body, make it all but certain that any locality planning a pilot safe consumption site would be quickly prevented from doing so. only two solutions to this reality exist: (1) a coordinated and prolonged campaign to decentralize the power of the state legislature and disperse more power back to local communities;160 or (2) convince the state legislature that a pilot site is essential for the public health of indiana residents through a robust advocacy and education campaign. though an idealistic notion, it is not completely outside of the realm of possibility. it is exactly what advocates did to get syringe exchange programs greenlighted just a few short years ago. moreover, indiana lawmakers have little to lose by enabling a pilot safe consumption site. such sites, as proposed here, would take no funding from state or local governments, but would instead have licensed nonprofits and private health care providers administer the sites at the direction of the local public health authority. similar structures have been proposed in utah,161 denver,162 and san francisco.163 most early legislation from these policymakers also imposes reporting requirements, strict oversight from the applicable public health authority, and mandatory regulation of facility administrators in terms of individual licensure, in-facility training, and delivery of treatment resources to site users.164 implementing similar measures in the design of a proposed pilot in indiana could help assure lawmakers of their oversight authority while abstaining from diverting public funds to the program – a more politically palatable compromise for more conservative legislators. c. other novel legal issues outside of the legal questions posed in pending litigation, a whole host of other novel legal issues surrounding safe consumption sites are likely to arise. related to the previously mentioned zoning and nimby fights, some attorneys caution due process claims are likely to crop up.165 the safehouse litigation has 160. claybourn, supra note 157. 161. nate emery, safe injection sites will save lives, if legislators let them, daily utah chron. (mar. 7, 2020), https://dailyutahchronicle.com/2020/03/07/emery-safe-injection-sites/ [https://perma.cc/75ek-57vx]. 162. anusha roy & jacob rodriguez, how safe injections sites would work in denver, 9news (nov. 28, 2018), https://www.9news.com/article/news/local/next/how-safe-injections-siteswould-work-in-denver/73-618624287 [https://perma.cc/46bu-8chg]. 163. jay barmann, mayor breed pushes again for safe injection sites, sfist (feb. 28, 2020), https://sfist.com/2020/02/28/mayor-breed-pushes-again-for-safe-injection/ [https://perma.cc/q52dyhst]. 164. id. 165. max mitchell, novel legal fights loom as the nation’s first safe consumption site gains court approval, legal intelligencer (feb. 26, 2020), https://www.law.com/ thelegalintelligencer/2020/02/26/novel-legal-fights-loom-as-nations-first-safe-injection-site-gains238 indiana health law review [vol. 18:215 already stirred up such a claim in philadelphia, with one local attorney claiming he has been approached with a claim from residents alleging that their home property values were being taken without due process because of the way the proposed location for the safehouse site had been determined.166 also, they maintain that they were not afforded a proper public hearing.167 since plans for this particular site have stalled, the issue is currently moot. however, it will assuredly rise again once a new location has been determined, providing a case of first impression for the courts. still, other challenges are plausible. additional zoning challenges, one real estate litigator anticipates, will center around permitted use disputes.168 zoning litigation commonly centers around common health care facility permits and definitions of things such as hospitals or residential recovery centers, but the precise definition and application of permitted use regulations for facilities like safe consumption sites will create a completely new regulatory scheme.169 professional licensing could also see some safe consumption site-related litigation. brian quinn, a philadelphia lawyer practicing in this area, specifically calls out the potential issues facing practicing health care professionals and their obligatory reporting requirements: would these workers be duty-bound to report seeing a fellow colleague visiting the site as a patient?170 would patient confidentiality bar them from such action? questions abound. anticipating the diverse and complex legal landscape in which the first safe consumption site would have to navigate is key to forming a comprehensive and successful implementation strategy and advocacy campaign. d. advocacy and implementation strategy assuming that a legal landscape for a safe consumption site pilot can be carved out, the next steps to realizing the actual implementation of a site will require innovative funding strategies, an aggressive public education campaign, and a supremely well-coordinated advocacy campaign. one of the biggest hurdles, aside from legal challenges, is how to fund and sustain a site once it has been greenlighted. safehouse operators in philadelphia, despite winning their initial court battle over the legality of their planned site and their own vows to open the site as appeals are ongoing, have had to stall opening partly for lack of funding.171 certainly, there would be no federal or state funding court-approval/ [https://perma.cc/8txf-v6ug]. 166. id. 167. id. 168. id. 169. id. 170. id. 171. max marin & nina feldman, supervised injection at prevention point? ahead of major ruling, safehouse lacks location and funding, billy penn (jan. 16, 2020), https://billypenn.com/ 2020/01/16/supervised-injection-at-prevention-point-ahead-of-major-ruling-safehouse-lackslocation-and-funding/ [https://perma.cc/vsj7-vcvs]. https://billypenn.com/about/max-marin/ https://billypenn.com/about/nina-feldman/ 2021] safer is better 239 available for such an endeavor, especially at the outset – federal and state funds still cannot be used to procure syringes for syringe exchange programs. thus, financial support will have to originate elsewhere. one potential model would be a partnership with an existing institution to secure affordable space or financial support. churches and other public health and welfare nonprofits would be ideal. in marion county, a particularly involved eastside church, the brookside community church, has been incredibly vocal in its support of harm reduction strategies and has partnered with the marion county health department to serve as a host site for its current syringe access program.172 as safe consumption sites increase in visibility and continue to become a more normalized feature of drug policy rhetoric, likely more prominent partners could be identified. in an ideal world, local hospitals and clinics that have existing relationships with vulnerable populations and communities of persons experiencing substance use disorders could house and administer physical safe consumption facilities. indianapolis’s eskenazi health stands out as a potential pilot operator, given its status as the public hospital for our county, its position under the health and hospital corporation umbrella, and close working relationship with the marion county public health department. such a partnership would provide space, funding, and trained medical staff to support and sustain safe consumption operations over the long-term. it would also serve to normalize the sites as places providing essential health care services. this could help destigmatize the use of such facilities. another critically important feature of this implementation strategy is the creation of a targeted public education campaign. a study found that only 29% of people support the legalization of safe consumption sites.173 while this is a dismaying statistic, it is important to view it through a contextual lens. for example, syringe exchange programs, now widely implemented, enjoy only a 39% public approval rating.174 so, while advocates will want to help craft a public health education campaign with regards to the efficacy of safe consumption sites as harm reduction mechanisms, high public support is not determinative of implementation, generally. where public support is critical with regards to the sites is when and where site locations are formally proposed. cities attempting to earmark locations for sites to be erected have, pretty resoundingly, been met with fierce resident opposition. empirically, residents do not want safe consumption sites in their backyards. this is despite the evidence that safe consumption sites generally reduce overdoses in the vicinity surrounding their location, as compared to other 172. david cederquist, why brookside partnered with safe syringe exchange program, brookside cty. church (apr. 17, 2019), https://www.bccindy.org/journey/why-safe-syringeexchange [https://perma.cc/z4j6-8rk4]. 173. emma mcginty et al., public support for safe consumption sites and syringe services programs to combat the opioid epidemic, 111 preventative med. 73, 73 (2018). 174. id. 240 indiana health law review [vol. 18:215 neighborhoods in the same city.175 while many factors can produce the effect of lowered drug overdoses, one recent study “demonstrate[d] that vancouver’s supervised injection facility appears to have had a localized yet significant effect on overdose mortality in the area of densely concentrated injection drug use where the facility is located.”176 opposition to locations proposed for a philly-based safe consumption site has contributed to the stalled safehouse plans in the wake of the nonprofit’s october 2019 trial court victory. despite assurances that safehouse would charge forth in opening the inaugural site during the appeals process, the group has faced staunch pushback from residents and neighborhood groups. this opposition movement spurned the proposal of a state bill designed to outlaw the sites altogether.177 support for the bill to criminalize the site garnered bipartisan support, owing to politicians’ frustration at the lack of community involvement in safehouse’s planning and implementation process.178 to be sure, safehouse’s advocacy strategy notably and mistakenly lacked community input on the location of the proposed site.179 this shortcoming has continued to deeply divide the community. rather than attempt to reach out to concerned neighborhood groups and opposition advocates, safehouse has leaned on medical professionals, public health experts, and academics to try to scientifically refute community concerns.180 this strategy has forged a deep divide between what many south philly residents view as an us vs. them dichotomy, with liberal-leaning academic elites pushing their harm reduction strategy on non-consenting residents.181 this tension was highlighted in a recent city council meeting on the matter, held march 16, 2020, where residents and public health officials verbally clashed.182 the path taken by safehouse and its 175. see brandon marshal et al., reduction in overdose mortality after the opening of north america’s first medically supervised safer injection facility: a retrospective population-based study, 377 lancet 1429 (2011). 176. brandon marshal et al., critique of lancet study of vancouver’s supervised injection site and overdose: authors’ response, b.c. ctr. for excellence in hiv/aids 5 (2011), http://www. cfenet.ubc.ca/sites/default/files/uploads/lancet-response.pdf [https://perma.cc/p6bv-qal5]. 177. anna orso, supervised injection site debate revives bill that would explicitly criminalize them, philly politicians say, phila. inquirer (mar. 2, 2020), https://www.inquirer.com/news/ supervised-injection-site-senate-bill-anthony-williams-kenyatta-johnson-20200302.html [https://perma.cc/2855-9zqh]. 178. id. 179. allison steel & justine mcdaniel, ‘disrespected’: how south philly mobilized against the proposed supervised injection site, phila. inquirer (feb. 28, 2020), https://www.inquirer. com/news/supervised-injection-site-safehouse-south-philadelphia-protest-20200228.html#loaded [https://perma.cc/5k3z-3qwj]. 180. id. 181. id. 182. tom beck, the safe injection site fight is shaping up to be a battle between residents and health experts, s. philly rev. (mar. 17, 2020), https://southphillyreview.com/2020/03/17/ the-safe-injection-site-fight-is-shaping-up-to-be-a-battle-between-residents-and-health-experts/ 2021] safer is better 241 advocates, by neglecting to foster open community dialogues regarding the sites, may have stunted progress on any establishment of a site in south philly in the near future, despite early legal success. future advocacy strategies must focus on building community buy-in, especially for the tough question: where to establish the sites. with a well-crafted, thoughtful, and culturally competent public education campaign designed to present the evidence-based benefits of safe consumption sites in a way that allows communities to collectively share ideas and concerns regarding the project, public health professionals, local lawmakers, and neighborhood groups can build support for these health care facilities. no community is untouched by substance use disorder, and increasingly, few individuals are either. communities are hungry for practical and efficacious solutions to the challenges presented by substance use disorder. public health advocates and policymakers can deliver on this need while simultaneously building trust and social infrastructure in the targeted community. v. conclusion dr. jonathan giftos, clinical director of substance use treatment for the new york city health and hospitals corporation, stated it best in a tweet, saying, “[n]o one is arguing that [supervised consumption sites] are the answer to our overdose crisis, but they would fill an enormous gap in [the] current care model — engaging a highly marginalized group of patients — and ultimately sav[ing] many lives.”183 while the solution proposed here to help bring a safe consumption pilot site to indiana would not constitute a one-stop solution to the broad problem of substance use disorder and its associated morbidities and mortalities in the state, it would be the first stop on a long journey toward destigmatizing and decriminalizing substance use disorder, recognizing illicit drug use as a symptom of an underlying disease, and providing resources for individuals to have a better chance mitigating recurrence of the symptoms and long-term recovery from the disease. safe consumption sites, until very recently, were either unknown or unfairly deemed radical fringe policy proposals in the united states. now, they are gaining recognition and acceptance as real harm reduction mechanisms in public health professional and policymaking circles. even more encouraging is the emerging national consciousness regarding safe consumption sites. even a few years ago, relatively few people outside the public health world were aware of what safe consumption sites were or that such facilities existed at all. yet, this once-obscure public health concept is now being discussed in mainstream pop culture. a prime-time medical drama, chicago med, recently introduced a major plotline revolving around a main character’s [https://perma.cc/4nwu-msr6]. 183. jonathan giftos (@jongiftosmd), twitter (aug. 28, 2018, 8:39 am), https://twitter.com/jongiftosmd/status/1034420183446773760 [https://perma.cc/ak77-czxm]. 242 indiana health law review [vol. 18:215 campaign to implement a safe consumption site run by the hospital. while health policy is certainly not set by fictional television plotlines, the mere fact that a major network would greenlight the storyline at all means that safe consumption sites are moving from the periphery to the mainstream of rhetoric and policy discourse. additionally, culture often shifts the political and social climate and can thrust fringe issues into the national spotlight. given that a january 2020 episode of chicago med was viewed by a whopping 8.37 million viewers,184 and chicago med’s routine position as a top-watched wednesday night network show week-to-week,185 its place in pop culture discourse is notable. as a main character delivered an impassioned monologue about how safe consumption sites could have prevented the overdose death of his beloved brother, i wondered how many casual entertainment consumers were painfully reminded of their own loved ones. doubtless, more than a few of those 8.37 million viewers have a family member or friend or are themselves struggling with a substance use disorder. certainly, i thought of dave and how differently his story would have read had he had access to one of these life-saving facilities. would he have slumped over, alone and unnoticed, in a darkened parking lot? or would he have had his overdose reversed by the skilled hands of a medical professional, in a brightly lit room, devoid of stigma and shame? would my friend still be alive? current indiana legislation is not reducing nor containing the devastating effects of substance use disorder. in the next decade, if practitioners and policymakers are to get serious about mitigating the consequences of substance use disorder and are to commit to prioritizing mortality and morbidity reduction over unproductive and unnecessarily harmful criminalization, they are going to have to implement the creation of safe consumption sites. indiana is poised to become a national public health leader, and it can pioneer a path forward to a future where individuals can have quality and quantity of life with and beyond substance use disorder. now is the time for indiana lawmakers to take up this mantle of change. 184. mitch metcalf, showbuzzdaily wednesday network scorecard 1.15.2020, showbuzzdaily (jan. 16, 2020), http://www.showbuzzdaily.com/articles/the-sked-wednesdaynetwork-scorecard-1-15-2020.html [https://perma.cc/l7nr-mkvp] 185. see alex welch, tv by the numbers tracking, tv by the numbers, https://tvbythenumbers.zap2it.com/ [https://perma.cc/6uvn-znfr] (last visited july 25, 2020). the public charge rule as public health policy medha d. makhlouf* introduction a recent gallup poll found that health care, the economy, and immigration are the top three most important political issues for u.s. voters.1 public charge policy—which relates to the admission of noncitizens based on the likelihood of dependence on the u.s. government for support—lies at the intersection of these three topics. at the same time, immigration and welfare reform are prominent agenda items for the current administration.2 noncitizens are subject to a public charge determination when they apply for a visa to travel to the united states, when they arrive at a port of entry, and when they apply for lawful permanent resident status.3 on october 10, 2018, the department of homeland security (“dhs”) released a notice of proposed rulemaking that would transform public charge policy that has existed for more than a century.4 the proposed rule would expand the application of public charge inadmissibility in several ways, such as considering an applicant’s enrollment in previously-excluded public benefit programs and identifying certain characteristics as “heavily weighed” negative factors in the test.5 one analysis found ninety-four percent of noncitizens who entered the united states without lawful permanent resident status had at least one characteristic that would be weighed negatively under the proposed rule, and forty-two percent had * j.d., yale law school; a.b., brown university. assistant professor of law and director, medical-legal partnership clinic, penn state university – dickinson law. i am grateful to the organizers of and participants in the indiana health law review symposium for inspiring this essay and to wendy e. parmet and cassandra burke robertson for their generous and thoughtful comments. i thank andrew ortner for his excellent research assistance. 1. frank newport, top issues for voters: healthcare, economy, immigration, gallup (nov. 2, 2018), https://news.gallup.com/poll/244367/top-issues-voters-healthcare-economyimmigration.aspx [https://perma.cc/9ngf-4mx2]. 2. see, e.g., office of mgmt. & budget, budget of the u.s. government: a new foundation for american greatness 15-17 (2018), https://www.whitehouse.gov/sites/ whitehouse.gov/files/omb/budget/fy2018/budget.pdf [https://perma.cc/7ner-e6t8]. 3. immigration and nationality act, 8 u.s.c. § 1101(a)(13) (2014) (defining “admission” and “admitted” to mean “the lawful entry of [an] alien into the united states after inspection and authorization by an immigration officer”); 8 u.s.c. § 1225(a)(1) (2008) (“an alien . . . who arrives in the united states . . . shall be deemed for purposes of this act an applicant for admission.”). an alien who has not been admitted to the united states is subject to the inadmissibility grounds under immigration and nationality act. 8 u.s.c. § 1255 (2008) (relating to applications for adjustment of status to lawful permanent resident). 4. inadmissibility on public charge grounds, 83 fed. reg. 51,114 (oct. 10, 2018) (to be codified at 8 c.f.r. pt. 103, 212, 213, 214, 245, and 248), https://www.govinfo.gov/content/pkg/ fr-2018-10-10/pdf/2018-21106.pdf [https://perma.cc/4kuv-3u6v]. 5. id. at 51,173 (proposing to consider previously excluded public benefit programs); id. at 51,198 (describing heavily weighed negative factors). 178 indiana health law review [vol. 16:177 characteristics that would be considered heavily weighed negative factors.6 common entrant characteristics that would be weighed negatively include having a household size of three or more, not having private health coverage, and not having a high school diploma—factors that have little or nothing to do with dependency on the government per se.7 the proposed rule was swiftly criticized by advocacy organizations focused on immigrants’ rights, access to health care, disability rights, and workers’ rights, among others.8 one category of objection to the proposed rule focuses on the negative impact on the health and welfare of the immigrant population residing in the united states.9 this essay identifies concern for public health as a factor in the development of public charge policy and demonstrates how the proposed rule abandons this rationale. part i describes how public charge policy has remained remarkably consistent over time, even when anti-immigrant sentiment and concerns about the costs of providing public benefits to immigrants brought about restrictions on immigrant access to public benefits. part ii demonstrates how the public health rationale has influenced the development of public charge policy. part iii argues that the changes to public charge policy proposed in october 2018 represent a departure from the longstanding incorporation of public health concerns into public charge policy. i argue that the proposed changes are tied to a broader 6. samantha artiga et al., estimated impacts of the proposed public charge rule on immigrants and medicaid, henry j. kaiser fam. found. (oct. 11, 2018), https://www.kff.org/ report-section/estimated-impacts-of-the-proposed-public-charge-rule-on-immigrants-andmedicaide-key-findings/ [https://perma.cc/yhw5-j8gx]. 7. id. 8. inadmissibility on public charge grounds: uscis proposed rule, 19-01 immigr. briefings 1, 22 (jan. 2019) (noting that the proposed rule “has come under fire from a number of individuals and organizations that represent or lobby on behalf of immigrants” and that “over 200,000 comments had been submitted”). see, e.g., public charge: a new threat to immigrant families, protecting immigrant families (oct. 2018), https://www.clasp.org/sites/default/ files/2018_publiccharge_blackandwhite.pdf [https://perma.cc/97a9-cku7] (immigrant rights); aclu publishes comments criticizing proposed rule on public charge: trump administration proposal aims to block immigrants with disabilities, aclu (dec. 10, 2018), https://www.aclu.org/ news/aclu-publishes-comments-criticizing-proposed-rule-public-charge [https://perma.cc/gr8rua4t] (disability rights); acp vows to “do what it takes’ to protect immigrants” access to health care, american college of physicians (oct. 19, 2018), https://www.acponline.org /advocacy/acp-advocate/archive/october-19-2018/acp-vows-to-do-what-it-takes-to-protectimmigrants-access-to-health-care [https://perma.cc/hcg2-dsnm] (health care access); statement on trump administration’s proposed “public charge” rule denying poor people the opportunity for immigration status and citizenship, harvesting just.: a blog by farmworker just. (sept. 24, 2018), https://www.farmworkerjustice.org/fj-blog/2018/09/statement-trump-administration-sproposed-public-charge-rule-denying-poor-people [https://perma.cc/jy8q-jtzv] (workers’ rights). 9. see, e.g., am. pub. health ass’n, comment letter on proposed rule on inadmissibility on public charge grounds (dec. 10, 2018), https://www.apha.org/-/media/files/pdf/advocacy/ testimonyandcomments/181210_apha_public_charge_comments.ashx?la=en&hash=56a1a126 fc49d31e1766368617b2284942a01b70 [https://perma.cc/5zap-qrpg]. 2019] the public charge rule as public health policy 179 agenda of more generally restricting access to health-supporting public benefits. finally, i make a normative case for maintaining the current limitations on public charge policy’s consideration of public benefits use by noncitizens. i. the durability of public charge policy over time public charge has been a part of immigration law ever since the federal government began comprehensively regulating immigration in the late nineteenth century.10 however, the roots of public charge can be traced to the colonial poor laws, which permitted localities to prevent from settling or removing outsiders who sought shelter or other necessities.11 in the late nineteenth and early twentieth centuries, more noncitizens were refused admission to and deported from the united states under the public charge law than under any other category of inadmissibility or deportability.12 although public charge remains a barrier to admission for noncitizens, the percentage of noncitizens refused admission on this ground has decreased since 1940.13 here, i trace the development of public charge law from its roots in colonial jurisdictions, to its incorporation into state law in the early years of the republic, and its ultimate expression as federal immigration law. the enduring dual principles at the heart of public charge policy are henceforth revealed: an effort to promote the entry of able-bodied and employable immigrants and, importantly, a commitment to assist members of the community who fall on hard times.14 a. historical precedents of public charge law early settlers in the united states established “poor laws” that were modeled on the elizabethan poor law of 1601, and the law of settlement and removal of 1662.15 the purpose of the poor laws was to establish governmental authority to provide aid to the poor.16 at the time, aid came primarily in the form of shelter in almshouses (also known as poorhouses or workhouses), which also provided food, clothes, and other necessities of life.17 the poor laws categorized poor or 10. act of aug. 3, 1882, ch. 376, § 2, 22 stat. 214. 11. torrie hester et al., historians’ comment on proposed rule on inadmissibility on public charge grounds (oct. 5, 2018), https://www.ilcm.org/wp-content/uploads/2018/10/historianscomment-fr-2018-21106.pdf [https://perma.cc/a3hh-5wmw]. 12. id. at 3. 13. jeanne batalova, michael fix, and mark greenberg, chilling effects: the expected public charge rule and its impact on legal immigrant families’ public benefits use 7 (2018). 14. see hester et al. passim, supra note 11. 15. shapiro v. thompson, 394 u.s. 618, 628 n.7 (1969). 16. papachristou v. city of jacksonville, 405 u.s. 156, 161-62 (1972) (discussing the history and purpose of the poor laws). 17. john e. hansan, poor relief in early america, vcu libr.: soc. welfare hist. project, https://socialwelfare.library.vcu.edu/programs/poor-relief-early-amer/ [https://perma. cc/l6r5-r9nm] (last modified oct. 17, 2018). 180 indiana health law review [vol. 16:177 otherwise dependent people as “worthy (e.g., orphans, widows, handicapped, frail elderly) and . . . unworthy (e.g. drunkards, shiftless, lazy).”18 these classifications determined the type of relief for which a person would qualify.19 poor laws also established the length of time that persons must have resided in a town before they became eligible for public aid.20 such categorizations of the “deserving” and “undeserving” poor and residency requirements persist in welfare programs to this day.21 although almshouses were open to the merely unlucky or temporarily unemployed, they “became a refuge for the sick, the severely disabled, frail elderly, and homeless children who were unable to work and had no one to care for them.”22 dr. victoria sweet, a physician and historian who worked in “the last almshouse in america,” writes: at one time, almost every county in the united states had an almshouse . . . as well as a county hospital. they had functioned together. the county hospital took care of the acutely ill, and the almshouse took care of the chronically disabled. in theory. in practice, the almshouse had been a catchall for everyone who didn’t fit someplace else—it was a shelter, a farm for the unemployed, a halfway house, and a rehabilitation center, as well as a hospital.23 the poor laws required localities to provide for the basic needs of residents who were unable to provide for themselves. however, maintenance of almshouses was expensive.24 therefore, the corollary to this obligation of providing assistance was the right of localities to prohibit dependent persons (or persons who were likely to become dependent) from residing in the jurisdiction if they had not already established residency at the time they became impoverished.25 the poor laws also provided the authority to expel or remove such persons from the 18. id. see also, elizabeth wisner, the puritan background of the new england poor laws, 19 soc. serv. rev. 381 (1945). 19. wisner, supra note 18, at 384. 20. see, e.g., an act ascertaining what shall constitute a legal settlement of any person in any town or district within this commonwealth, so as to entitle him to support therein in case he becomes poor and stands in need of relief and for repealing all laws heretofore made respecting such settlement, ch. 0034, 1793 mass. acts (“any person, being a citizen as aforesaid and of the age of twenty one years, who shall hereafter reside in any town or district with this commonwealth for the space of ten years together and pay all state, county, town or district taxes assessed on such person's poll or estate for any five years within said time, shall thereby gain settlement in such town or district.”). 21. lauren d. appelbaum, the influence of perceived deservingness on policy decisions regarding aid to the poor, 22 pol. psychol. 419, 419-20 (2001). 22. hansan, supra note 17. 23. victoria sweet, god’s hotel: a doctor, a hospital, and a pilgrimage to the heart of medicine 8 (2012). 24. hansan, supra note 17. 25. id. 2019] the public charge rule as public health policy 181 jurisdiction if they did not leave willingly.26 after the establishment of the republic, colonial poor laws were transformed into laws governing the entry of outsiders into states like new york and massachusetts.27 the origins of poverty-related immigration restrictions in the united states lie in these individual state laws, in that they authorized noncitizen entry into the jurisdiction and enabled the deportation of noncitizen residents for specified reasons.28 for example, anti-irish sentiment motivated the development of an 1837 law in massachusetts which authorized the exclusion of immigrants who had been impoverished in any other country, or who suffered from health conditions that would prevent them from supporting themselves.”29 these state public charge laws were the basis for the incorporation of public charge exclusion and deportation provisions in the first federal immigration laws.30 b. public charge in early immigration law the first comprehensive federal immigration law, passed in 1882, included a provision denying entry to “any convict, lunatic, idiot, or any person unable to take care of himself or herself without becoming a public charge.”31 in 1891, the law was broadened to exclude not only those who were unable to provide for themselves at the time of entry, but also those who were “likely to become a 26. see, e.g., the honorable gen. court of mass., acts and laws of the commonwealth of massachusetts, an act providing for the relief and support, employment and removal of the poor, and for repealing all former laws made for those purposes 491-92 (boston, wright & porter printing co. 1895). 27. see n.y. (state) comm’rs of emigration, annual reports of the commissioners of emigration of the state of new york: from the organization of commission, together with tables and reports, & other official documents. comp. and prepared under resolution adopted by the bd., aug. 29, 1860, 12 (1861) (prohibiting the entry of “any lunatic, idiot, deaf and dumb, blind or infirm persons, not members of emigrating families, and who . . . are likely to become permanently a public charge”); the honorable gen. court of mass., acts and resolves passed by the general court of massachusetts, an act relating to alien passengers 339 (dutton and wentworth 1850) (describing the bond or fee that shipmasters were required to pay for each arriving alien, ensuring that he or she is not “a pauper, lunatic, or idiot, or maimed, aged, infirm or destitute, or incompetent to take care of himself or herself, without becoming a public charge as a pauper”); mass. comm’rs of alien passengers & foreign paupers, report of the commissioners of alien passengers and foreign paupers 5-6 (1852) (regarding “the establishment of four district almshouses for the accommodation of all aliens who become a public charge upon the commonwealth”). 28. hidetaka hirota, expelling the poor: atlantic seaboard states and the nineteenth-century origins of american immigration policy 180-204 (2017). 29. id. at 55 (quoting the honorable gen. court of mass., acts and resolves passed by the general court of massachusetts, an act relating to alien passengers 339, dutton and wentworth 1850). 30. id. at 182. 31. act of aug. 3, 1882, ch. 376 § 2, 22 stat. 214 (regulating immigration). 182 indiana health law review [vol. 16:177 public charge.”32 an additional provision authorized the deportation of any noncitizen who “becomes a public charge within one year after his arrival in the united states from causes existing prior to his landing therein.”33 in 1917, this provision was amended to authorize the deportation of noncitizens who become a public charge within five years of arrival, which remains the law today.34 two important insights to draw from the law of public charge deportability are: (1) that noncitizens who resided in the united states longer than one year had established residency of some sort, and were therefore no longer subject to deportability under the public charge ground; and (2) that a noncitizen would not be deported for becoming a public charge within one year for causes that arose after his or her arrival in the united states.35 rather, such persons, having established residency or having fallen on hard times after entry, were eligible for public support. the deportability ground was limited to noncitizens who were expected to be dependent on public aid for basic needs for the foreseeable future, with residence in public charitable institutions such as almshouses and hospitals as the paradigm of substantial dependence.36 use of other public benefits that emerged in the early twentieth century, such as english classes or public health programs, were not considered in determinations of public charge deportability as their purpose was to integrate immigrants rather than to support them financially.37 this was true under the colonial poor laws as well as under state and early federal immigration laws.38 although the majority of exclusions and deportations of noncitizens in the earlyto mid-twentieth century were attributable to the public charge laws, historians have noted that “the number . . . remained small, especially when compared to the numbers admitted.”39 c. the expansion of public benefits during the twentieth century, state and federal—as opposed to local—governments became increasingly responsible for the design and administration of a broad array of public benefit programs. this shift was set in 32. 1891 immigration act, ch. 551, 26 stat. 1084. 33. id. 34. act of feb. 5, 1917, ch. 29, § 19, 39 stat. 874. 35. id. 36. hester et al., supra note 11, at 3; immigration services, annual report of the commissioner-general of immigration to the secretary of the treasury 10 (washington: government printing office, 1896), https://babel.hathitrust.org/cgi/pt?id=osu.32435027600600; view=1up;seq=16 (stating that “no immigrant landed in this country within [fiscal year 1895-96] is now a burden upon any public or private institution); id. (also noting that 1,946 immigrants “fell into temporary distress and became public charges” from causes arising within one year after entry, but they were not returned to their country of origin). 37. hester et al., supra note 11, at 4. 38. id. at 3. 39. id. 2019] the public charge rule as public health policy 183 motion by the passage of the social security act of 1935.40 in addition to establishing social security retirement benefits, the act created three new federal programs to provide need-based income support (what we now call “welfare”) to people who fit within specified categories of the deserving poor: fatherless children, the aged, and the blind.41 the first laws to authorize permanent, federally-funded housing were also enacted in the 1930s.42 the 1960s and 1970s saw another large expansion of public benefit programs, including the establishment of medicaid, medicare, food stamps, head start, and job training programs and child care for parents receiving welfare.43 throughout this period, as the array of public benefit programs expanded dramatically, the public charge ground of deportability remained a little-used provision of immigration law, in part because its main limitations are enshrined in statute: it can only be invoked for causes existing prior to entry and only for a limited period following a noncitizen’s entry.44 in 1948, application of public charge deportability became even more restrictive when the board of immigration appeals (“bia”), the appellate administrative body for interpreting immigration laws, established a new three-part test in matter of b-.45 in order to establish that a noncitizen is deportable under the public charge ground, (1) the state must have imposed a charge upon the noncitizen for services rendered; (2) the state must have demanded payment from the noncitizen; and (3) the noncitizen must have failed to pay the charge.46 deportations based on public charge remain rare.47 40. social security act of 1935, ch. 531, 49 stat. 620; karen m. tani, states of dependency: welfare, rights, and american governance, 1935-1972 3 (cambridge university press 2016). 41. karen m. tani, administrative equal protection: federalism, the fourteenth amendment, and the rights of the poor, 100 cornell l. rev. 825, 829 (2015). the programs were called aid to dependent children, old age assistance, and aid to the blind. id. 42. national housing (capehart) act of 1934, ch. 847, 48 stat. 1246 (enacted june 27, 1934); u.s. housing (wagner-steagall) act of 1937, ch. 896, 50 stat. 888 (enacted september 1, 1937). 43. food stamp act of 1964, 7 u.s.c.a. § 2011 et seq. (1964); social security act, 7 u.s.c.a. § 1396 (title xix on medicaid); social security act, 7 u.s.c.a. § 1395 (title xviii on medicare); economic opportunity act of 1965, pub. l. 88-452 (creating head start); social security act, 7 u.s.c.a. § 601 et. seq. (funding child care services for parents receiving aid to families with dependent children, in order to allow them to participate in work and training programs; establishing win child care services to enable parents receiving afdc to participate in the work incentive (win) program); social security act, 7 u.s.c.a. § 1397a (expanding eligibility for subsidized child care to low-income families not receiving afdc). 44. immigration and nationality act, 8 u.s.c. § 1227(a)(5) (2008) (“any alien who, within five years after the date of entry, has become a public charge from causes not affirmatively shown to have arisen since entry is deportable.”). 45. matter of b-, 3 i&n dec. 323 (bia 1948). 46. id. at 326. 47. field guidance on deportability and inadmissibility on public charge grounds, 64 fed. reg. 28,689, 28,691 (may 26, 1999). 184 indiana health law review [vol. 16:177 public charge deportation policy continued to echo the dual principles described in the previous section: once noncitizens become members of the community, they are eligible to receive the full array of public benefits without any danger of being removed from the country. historians have noted the logic behind this principle: “[t]o deport an immigrant who became ill or disabled from causes subsequent to entry would unfairly hold the country of origin responsible and contradict the intent of the inadmissibility grounds.”48 for example, during the great depression, the immigration and naturalization service (“ins”) did not consider noncitizens deportable if they received public aid on account of unemployment.49 in addition, there seemed to be an implicit recognition that access to public benefits would help to integrate immigrants and ensure their long-term self-sufficiency. even in cases in which deportation under the public charge ground was warranted, courts frequently used their discretion to suspend deportation based on the principle of promoting integration.50 throughout the expansion of federal public benefit programs in the twentieth century, public charge policy as it related to both inadmissibility and deportability remained remarkably consistent.51 public charge policies in each context are distinct, but related. the dual principles underlying the policy of public charge deportability have strongly influenced the development of public charge inadmissibility: noncitizens who are considered members of the community are eligible to receive an array of public benefits without the threat of negative immigration consequences. in both contexts, public charge determinations did not consider use of public benefits that were intended to subsidize health care (other than for long-term institutional care), housing, and food.52 such programs were understood to supplement rather than fully provide for the basic needs of lowincome people.53 for example, receipt of public health services such as immunizations or medical treatments to ensure healthy development (prenatal care, for example) was not considered evidence of dependence.54 only public benefit programs that provided long-term institutionalization and cash benefits 48. hester et al., supra note 11, at 4. 49. mae ngai, impossible subjects: illegal aliens and the making of modern america 72 (princeton univ. press, 2004). 50. see leo m. alpert, the alien and the public charge clauses, 49 yale l. j. 18, 22 (1939) (describing cases in which the public charge deportability clause was not applied to noncitizen families who were supported by welfare). 51. hester et al., supra note 11, at 1. 52. field guidance on deportability and inadmissibility on public charge grounds, 64 fed. reg. 28,689 (may 26, 1999) (“it has never been service policy that any receipt of services or benefits paid for in whole or in part from public funds renders an alien a public charge, or indicates that the alien is likely to become a public charge. the nature of the public program must be considered.”). 53. id. at 28,689, 28,692 (“[n]on-cash benefits (other than institutionalization for long-term care) are by their nature supplemental”); id. (excluding food stamps from the department of state’s public charge inadmissibility determination because of its “supplemental” nature). 54. id. at 28,693. 2019] the public charge rule as public health policy 185 were considered in the public charge determination, as reliance on such benefits was believed to indicate substantial dependence on government support.55 in their applications for adjustment of status to lawful permanent resident, noncitizens are subject to a “totality of the circumstances” analysis in order to determine whether they are likely to become a public charge.56 use of public benefits while living in the united states is one factor among many—including age, health, family status, education, assets, resources, and financial status—used to assess the likelihood that a noncitizen is inadmissible under the public charge ground.57 the different analyses for public charge inadmissibility and deportability reflect the forward-looking and backward-looking nature of the examinations, respectively. public charge deportability has to do with whether a noncitizen has come to the united states without intending to rely on government support and has since become a member of the community whom the state is obligated to support. for this reason, the analysis focuses on use of certain public benefits that indicate total, or near-total, dependence on the government within a noncitizen’s first five years of entry, for reasons predating that entry.58 inadmissibility, on the other hand, is concerned with whether a noncitizen is “likely to become a public charge at some future time.”59 therefore, the inadmissibility test assesses a broader array of factors that suggest whether a noncitizen is likely to become totally or nearly totally dependent on the government for support in the future.60 d. restrictions on immigrant eligibility for public benefits throughout most of the twentieth century, noncitizens were generally eligible 55. alpert, supra note 50, at 22-28 (describing residence in charitable institutions and “welfare relief” as the principal types of public assistance considered in public charge determinations); id. at 23 (“it is the type of relief today usually called general public assistance, welfare relief, or home relief, that is the modern counterpart of the pauper, almshouse and charity concept.”) 56. field guidance on deportability and inadmissibility on public charge grounds, 64 fed. reg. 28,689 (may 26, 1999). 57. immigration and nationality act § 212(a)(4)(b); see also 9 fam 302.8-2(b)(2)(a)(2), 302.8-2(b)(3)(a)(1) (2016). 58. see immigration and nationality act § 241(a)(5). 59. matter of harutunian, 14 i&n dec. at 589. 60. see id. at 588 (“the administrative authorities have adopted the view that, while economic factors should be taken into account, the alien’s physical and mental condition, as it affects ability to earn a living, is of major significance.”); 1950 omnibus report of the senate judiciary committee, s. rep. no. 81-1515, at 346-50 (2d sess. 1950) (“since the elements constituting likelihood of becoming a public charge are varied, there should be no attempt to define the term in the law, but rather to establish the specific qualification that the determination of whether an alien falls into that category rests within the discretion of the consular officers or the commissioner.”). 186 indiana health law review [vol. 16:177 for public aid.61 this included eligibility for the major benefit programs enacted in the 1960s, such as medicaid,62 aid to families with dependent children (“afdc,” the successor program to aid to dependent children),63 food stamps,64 and federal housing assistance programs.65 in general, at the time such programs were created, eligibility criteria related to citizenship or immigration status did not exist.66 however, reform of the immigration laws in 1965 caused an increase in immigration, including among undocumented immigrants, which led to closer scrutiny of the costs of providing access to public benefits for immigrants.67 in the 1970s, new laws began to restrict undocumented immigrants’ 61. cybelle fox, unauthorized welfare: the origins of immigrant status restrictions in american social policy, 102 j. am. hist., 1051, 1057 (2016). (“between 1935 and 1971 no federal laws barred noncitizens, even unauthorized immigrants, from social security benefits, unemployment insurance, [old age assistance], or adc . . . . with the enactment of additional public assistance legislation—creating the food stamp program or medicaid, for example—the same rules applied. under federal law, both authorized and unauthorized immigrants were eligible for these programs on the same basis as citizens.”); richard a. boswell, restrictions on noncitizens’ access to public benefits, 42 ucla l. rev. 1475, 1492-93 (1994) (“it was not until approximately 1972 that congress began to enact restrictions on access to benefit programs based on either immigration or citizenship status.”); see also tanya broder et al., , overview of immigrant eligibility for federal programs, nat’l immig. l. ctr. (2015), https://www.nilc.org/wpcontent/uploads/2015/12/overview-immeligfedprograms-2015-12-09.pdf [https://perma.cc/h6qa5e9w]. 62. janet m. calvo, alien status restrictions on eligibility for federally funded assistance programs, 16 n.y.u. l. rev. & soc. change 395, 418 (1987-88) (“the first federal restriction on the availability of medicaid to aliens was a regulation which limited eligibility to legal permanent residents and aliens permanently residing in the united states under color of law.”) (citing 45 c.f.r. § 248 (1973)). 63. omnibus budget reconciliation act, pub. l. no. 97-35, § 2320(a)(3), 95 stat. 357, 857 (1981) (codified as amended 42 u.s.c. § 602(a)(33) (supp. iv 1986) (limiting eligibility for afdc to aliens who are permanent residents or “permanently residing in the united states under color of law” (prucol)); fox, supra note 61, at 1057 (“by 1948 only texas barred noncitizens from adc benefits”); boswell, supra note 61, at 1489 (“in order to be eligible, a dependent child and all in his or her ‘assistance unit’ must be either u.s. citizens, lawful permanent residents, or prucol . . . [i]t seems that deportable persons who are present and allowed to remain in the united states with the knowledge of the ins may be eligible to receive benefits under prucol.”) (internal citations omitted). 64. boswell, supra note 61, at 1490 (describing immigration status eligibility criteria for food stamp recipients, which were more restrictive than for the other programs mentioned); calvo, supra note 62, at 402-03 (describing restrictions on the eligibility of aliens for food stamps before and after the immigration reform and control act of 1986). 65. calvo, supra note 62, at 408 (“in 1981, congress limited the eligibility for federally assisted housing programs to aliens in specific statuses.”) (citing 42 u.s.c. § 1436a(a) (1982)). 66. see fox, supra note 61, at 1053 (“when the modern welfare state was established in 1935 no federal laws barred non-citizens, even unauthorized immigrants, from social assistance.”). 67. see id. at 1054 (“the roots of federal restriction . . . stretch back to the 1960s, when 2019] the public charge rule as public health policy 187 access to federal public benefits, including supplemental security income (“ssi”)—a new program—in 1972,68 medicaid and afdc in 1973, food stamps in 1974, federal unemployment insurance in 1976.69 in 1996, congress passed welfare reform legislation that severely restricted lawful immigrants’ access to federal public benefits.70 these restrictions aimed to reduce federal spending on public benefit programs and to deter noncitizens from coming to the united states to access public benefits.71 the personal responsibility and work opportunity reconciliation act (“prwora”) created two categories of immigrants for purposes of eligibility for federal public benefits: qualified aliens and non-qualified aliens.72 the term “qualified alien” does not originate in immigration law, and the category includes noncitizens with many different types of statuses, including lawful permanent residents and humanitarian immigrants such as refugees and asylees.73 qualified aliens are barred from eligibility for federal public benefits until five years after the date they become qualified, a provision commonly referred to as the “five-year bar.”74 in general, non-qualified aliens are not eligible for federal programs that provide changes in immigration and welfare policy led to an unexpected rise in unauthorized migration and an expansion of the welfare rolls.”). 68. social security amendments of 1972, pub. l. no. 92-603, § 1614(a)(1)(b)(ii), 86 stat. 1329, 1471; supplemental security income for the aged, blind, and disabled, 52 fed. reg. 21,939 (june 10, 1987), 20 c.f.r. § 416.1618 (1988) (stating that aliens are eligible for ssi if they are permanent residents, temporary residents, special agricultural workers, replenishment agricultural workers, or prucol); fox, supra note 61, at 1055 (describing how “[f]or almost four decades social security officials interpreted [the act] to mean that unauthorized immigrants were . . . eligible for” programs administered by the ssa); boswell, supra note 61, at 1490. 69. fox, supra note 61, at 1059; see boswell, supra note 61, at 1492-93; calvo, supra note 62, at 418, 420-21 (regarding restrictions on the eligibility of aliens for medicaid from 1973-1988 and for afdc from 1981-1987). 70. personal responsibility and work opportunity reconciliation act of 1996, 8 u.s.c. § 1612 (1996). 71. h.r. rep. no. 104-430, at 146 (1995), as reprinted in 1996 u.s.c.c.a.n. 2105, 2260 (describing the two main objectives of prwora as “to assure that aliens be self-reliant in accordance with national immigration policy . . . [and] to remove the incentive for illegal immigration provided by the availability of public benefits.”). however, it is far from certain whether restricting immigrant eligibility for public benefits accomplishes either goal, a topic i explore in prior work. see medha d. makhlouf, health justice for immigrants, 4 u. penn. j.l. & pub. aff. 235, 266-71 (2019). 72. personal responsibility and work opportunity reconciliation act of 1996, pub. l. no. 104-193, 110 stat. 2105 (aug. 22, 1996) (codified as amended in scattered sections of 42 u.s.c.). 73. prwora § 431(b), 110 stat. at 2274 (codified in 8 u.s.c. § 1641(b)); see also william wilberforce trafficking victims protection reauthorization act of 2008, pub. l. no. 110-457, 122 stat. 5063 § 211 (dec. 23, 2008) (adding certain survivors of trafficking to the definition of “qualified alien”). 74. prwora § 431, 110 stat. 2105, 2274 (codified in 8 u.s.c. § 1641). exemptions from the five-year bar to certain categories of immigrants, such as refugees and asylees. 8 u.s.c. § 1612. 188 indiana health law review [vol. 16:177 “any retirement, welfare, health, disability, public or assisted housing, postsecondary education, food assistance, unemployment benefit, or any other similar benefit.”75 however, certain federally funded programs that support health and well-being remain accessible to noncitizens regardless of status.76 these include emergency medicaid; public health programs that provide immunizations and treatment of communicable disease symptoms; school breakfast and lunch programs; k-12 public education; the special supplemental nutrition program for women, infants, and children (“wic”); short-term non-cash emergency disaster assistance; and head start.77 this dramatic—but not total—restriction on immigrants’ eligibility for federal public benefits necessitated clarification from the ins about how use of public benefits would impact inadmissibility and deportability under the public charge ground. in 1999, the ins released a field guidance defining a “public charge” as “an alien who has become (for deportation purposes) or who is likely to become (for admission or adjustment purposes) ‘primarily dependent on the government for subsistence, as demonstrated by either the receipt of public cash assistance for income maintenance, or institutionalization for long-term care at government expense.’”78 this policy accurately reflects the historical principles underlying public charge, in that it takes into consideration use of public benefits that would indicate “a complete, or nearly complete, dependence on the government rather than the mere receipt of some lesser level of financial support.”79 under this policy, which is still in effect, immigration officers consider use of public benefits as a factor in the public charge determination only if an applicant for adjustment of status has received ssi, cash assistance from temporary assistance for needy families (“tanf,” the successor to afdc), state or local cash assistance programs for income maintenance, or medicaid for long-term care in a nursing home or mental health institution.80 ins reached this decision after consulting with the social security administration, the department of health and human services, and the department of agriculture, concluding that “non-cash benefits generally provide supplementary support in the form of vouchers or direct services to support nutrition, health, and living condition needs.”81 there was also an implicit understanding that such benefits “are often 75. prwora § 401(c)(1)(b), 110 stat. at 2113 (codified in 42 u.s.c. § 601). 76. 8 u.s.c. §§ 1611(b), 1613(c). 77. id.; see also 83 fed. reg. 51,128, table 3 (listing programs that are exceptions from the definition of federal public benefit under prwora); 83 fed. reg. 51,131-32 (describing exempted programs in detail). 78. field guidance on deportability and inadmissibility on public charge grounds, 64 fed. reg. 28,689 (may 26, 1999). see also dep’t of state, 9 fam 302.8-2(b)(1)(a)(1) (defining “public charge” in the same way). 79. inadmissibility and deportability on public charge grounds, 64 fed. reg. 28,676, 28,677 (may 26, 1999). 80. id. 81. id. at 28,677-78. public benefits that are not currently considered in the public charge determination include medicaid: public health services; use of community health clinics; short-term 2019] the public charge rule as public health policy 189 provided to low-income working families to sustain and improve their ability to remain self-sufficient.”82 provision of such benefits to noncitizens—even during a period of increasing concern over the costs of social welfare programs and the volume of new immigrants—was understood as the nation’s “commitment to assist members of our communities who fall on hard times,” and not as a basis for punitive immigration consequences.83 relatedly, humanitarian immigrants such as refugees and asylees who are exempt from the five-year bar on eligibility for federal public benefits are also exempt from the public charge grounds of inadmissibility and deportation.84 it is broadly understood that such immigrants often come into the country with few resources, and that providing immediate access to public benefits to them without any risk of negative immigration consequences is good policy for promoting their long-term self-sufficiency. ii. public health concerns in the development of public charge policy public health concerns have influenced the development of public charge policy. public health is defined as what “we as a society do collectively to assure the conditions in which people can be healthy.”85 public benefits programs are a collectively-funded safety net designed to promote public health and create other positive effects on society by addressing the social determinants of health (“sdoh”).86 the world health organization defines sdoh as “the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life.”87 the sdoh are widely rehabilitation services; prenatal care and emergency medical services; chip; nutrition programs; housing benefits; child care services; energy assistance; emergency disaster relief; foster care and adoption assistance; educational assistance; job training programs; in-kind, community based programs such as soup kitchens, crisis counseling, etc.; non-cash benefits under tanf (subsidized child care or transit subsidies); earned cash payments such as social security; government pensions and veterans benefits; and unemployment compensation. hester et al., supra note 11, at 7-8. 82. 64 fed. reg. at 28,678. see also id. at 28,678 (“non-cash benefits . . . are by their nature supplemental and frequently support the general welfare.”). 83. hester et al., supra note 11, at 9. by highlighting these assumptions underlying the development of public charge policy, i do not intend to minimize the problematic way in which public charge has been used to exclude “undesired” groups throughout the nation’s history. this is due in part to the broad, readily abusable discretion that consular and border officials have in making public charge determinations. see, e.g., douglas c. baynton, defectives in the land: disability and american immigration policy, 24 j. am. ethnic hist. 31, 33 (2005). 84. 8 u.s.c. § 1613(b)(1) (2019) (exemption from five-year bar); 8 u.s.c. § 1182(a)(4) (2019) (exemption from public charge ground of inadmissibility). 85. inst. of med., the future of public health (1998). 86. see generally elizabeth h. bradley & lauren a. taylor, the american health care paradox: why spending more is getting us less (2013). 87. social determinants of health, world health org., https://www.who.int/social_ 190 indiana health law review [vol. 16:177 acknowledged to have a significant effect on individual and population health, although the precise mechanisms of causation are complex and not fully understood.88 the laws governing public benefit programs, which redistribute public resources to ameliorate the grossest inequalities in society (lack of basic necessities like food and shelter) are prime examples of “incidental health law,” or “policies that are not primarily focused on health, but may nonetheless be creating health benefits or harms.”89 although immigration laws are less commonly considered incidental health laws, public charge policy is unique in that, for a significant subpopulation within the united states, it can directly influence the decision to access subsidized health coverage and other healthpromoting public benefits.90 section ii.a describes the relationship between financial resource strain, the sdoh, and public benefit programs. section ii.b identifies instances in which the ins and its successor, the dhs, have explicitly and implicitly recognized public health rationales in developing public charge policy. a. financial resource strain and social determinants of health public benefit programs address sdoh by providing direct services, vouchers, or cash benefits to people who are experiencing financial resource strain. the american public health association (“apha”) has referred to the services provided by public benefit programs as “the bedrock of the public health infrastructure.”91 there is an “extensive body of research recognizing that enrollment in public assistance programs contributes to positive health outcomes, determinants/en/ [https://perma.cc/w84g-8fyg]. 88. see secretary’s advisory committee on national health promotion and disease prevention objectives for 2020, u.s. dep’t of health & human serv. (july 26, 2010), http://www.healthypeople.gov/2010/hp2020/advisory/societaldeterminantshealth.htm [https://perma.cc/f7c3-dxnx]; scott burris, law in a social determinants strategy: a public health law research perspective, 126 pub. health rep. 22, 26 (2011) (“there is unquestionably a need for more study of social determinants, their complex role in causing health outcomes, and the effectiveness of policy changes in addressing them.”). 89. burris, supra note 88, at 26. 90. changes in federal policy regarding immigrant access to public benefits in the 1970s led immigrant communities to delay care: “‘[w]ithin the tightly knit’ immigrant community ‘word spread quickly about the danger of visits to health centers. many people . . . heard of someone who had been deported when they had sought . . . treatment at a health center.’ medical students at irvine noted the dangers of delayed care. and the dean of the medical center reported feeling ‘disgust, shame, and anger’ at being pressured to ‘implement what are essentially immigration service functions.’” fox, supra note 61, at 1069 (describing a 1974 study of access to medical care for undocumented immigrants in orange county, california). in a forthcoming work, i plan to explore this phenomenon of “health care system avoidance” among noncitizens in detail. 91. am. pub. health ass’n, supra note 8. 2019] the public charge rule as public health policy 191 economic mobility, and self-sufficiency.”92 the public benefit programs that dhs proposes to consider in public charge determinations impact public health in many ways. access to affordable health insurance supports public health. medicaid, the means-tested public health insurance program, is “an essential source of health insurance for low-income individuals and families, children, pregnant women, individuals with disabilities, and other underserved population groups” in the united states, covering one-fifth of the population.93 health coverage enables enrollees to access a wide array of health services they otherwise might not be able to afford.94 for example, studies have found that medicaid increases access to preventative care such as well-child visits and cancer screenings,95 and that it is associated with a broad array of improved health outcomes, from fewer hospitalizations96 and emergency department visits97 to improved oral health.98 access to health coverage through medicaid also lifts families out of poverty, which can shield children from adverse experiences and “toxic stress” that can 92. id. 93. nat’l health law program team, national health law program comments filed on proposed public charge rule change, nat’l. health l. program (dec. 10, 2018), https://healthlaw.org/resource/national-health-law-program-comments-filed-on-proposed-publiccharge-rule/ [https://perma.cc/r2m9-g9j6]. 94. id. 95. julia paradise, data note: three findings about access to care and health outcomes in medicaid, henry j. kaiser fam. found. (mar. 23, 2017), https://www.kff.org/medicaid/issuebrief/data-note-three-findings-about-access-to-care-and-health-outcomes-in-medicaid/ [https://perma.cc/9hvg-mf9a]. 96. sarah miller & laura r. wherry, the long-term effects of early life medicaid coverage 3-4 (2015), http://www-personal.umich.edu/~mille/millerwherry_prenatal2015.pdf [https://perma.cc/9qlc-ubaz] (finding that “in utero medicaid coverage lowers hospitalizations for conditions that have been previously shown to be sensitive to the in utero environment”). 97. laura r. wherry et al., childhood medicaid coverage and later life health care utilization, 287 (nat’l bureau of econ. research, working paper no 20929, 2015), https://www.nber.org/papers/w20929.pdf [https://perma.cc/m5xr-bp3z] (finding that more years of childhood eligibility for medicaid among blacks is associated with a 7% to 15% decrease in hospitalizations and 2% to 5% decrease in emergency department visits). 98. brandy j. lipton et al., previous medicaid expansion may have had lasting positive effects on oral health of non-hispanic black children, 35 health aff. 2249, 2249 (2016), h t tps:/ /www.academyhealth .org/f iles/hea lth % 2 0 aff -2 0 1 6 -lip ton-2249-58 .pdf [https://perma.cc/8v7c-8cpy]. for a review of studies examining the impact of medicaid expansion, see olena mazurenko et al., the effects of medicaid expansion under the aca: a systematic review, 37 health aff. 944 (2018); and larisa antonisse et al., the effects of medicaid expansion under the aca: updated findings from a literature review, henry j. kaiser fam. found. (mar. 28, 2018), https://www.kff.org/medicaid/issue-brief/the-effects-of-medicaidexpansion-under-the-aca-updated-findings-from-a-literatu re-review-march-2018/ [https://perma.cc/duf5-jx6z] (finding that “multiple new studies demonstrate a positive association between expansion and health outcomes.”). 192 indiana health law review [vol. 16:177 affect their health later in life.99 ultimately, medicaid has been found to improve population health through its positive effects on enrollees’ health behaviors, access to care, and health outcomes.100 the compound effect of medicaid coverage is improved socioeconomic mobility for children.101 the supplemental nutrition assistance program (snap or food stamps) is the nation’s largest and most important anti-hunger program; in 2015, snap lifted 8.4 million people out of poverty, reducing the poverty rate by 17 percent.102 by supplementing the food budgets of millions of families across the country, snap “improves dietary quality, protects against obesity, and improves health, especially among children.”103 food insecurity is associated with common and costly health problems such as diabetes, heart disease, obesity, hypertension, chronic kidney disease, and depression.104 by addressing food insecurity directly, snap is an important piece of a public health strategy to reduce the incidence of these common and costly health problems.105 public housing programs subsidize the cost of rent for low-income tenants in order to counter the effects of housing instability.106 such programs are “a critical 99. karina wagnerman, alisa chester, & joan alker, medicaid is a smart investment in children, geo. u. health pol’y inst. ctr. for child. and families (mar. 2017), https://ccf.georgetown.edu/wp-content/uploads/2017/03/medicaidsmartinvestment.pdf [https://perma.cc/nz2j-j3fy]. 100. sara r. collins, munira z. gunja, michelle m. doty, & sophie beutel, americans’ experiences with aca marketplace and medicaid coverage: access to care and satisfaction, the commonwealth fund (may 25, 2016) https://www.commonwealthfund.org/publications/issuebriefs/2016/may/americans-experiences-aca-marketplace-and-medicaid-coverage [https://perma.cc/4huk-sfct]. 101. sarah miller & laura r. wherry, the long-term effects of early life medicaid coverage, j. hum. resources (2018). 102. laura wheaton & victoria tran, the antipoverty effects of the supplemental nutrition assistance program (2018) https://www.urban.org/sites/ default/files/publication/96521/the_antipoverty_effects_of_the_supplemental_nutrition_assistan ce_program_3.pdf [https://perma.cc/vtq2-sa9s]. 103. food res. & action ctr., the role of supplemental nutrition assistance program in improving health and well-being (2017), http://frac.org/wp-content/uploads/ hunger-health-role-snap-improving-health-well-being.pdf [https://perma.cc/hh6j-pdl5]. 104. id. 105. 7 u.s.c. § 2011 (“it is hereby declared to be the policy of congress, in order to promote the general welfare, to safeguard the health and well-being of the nation’s population by raising levels of nutrition among low-income households . . . [t]o alleviate such hunger and malnutrition, a supplemental nutrition assistance program is herein authorized which will permit low-income households to obtain a more nutritious diet through normal channels of trade by increasing food purchasing power for all eligible households who apply for participation.”); the food stamp act of 1964, 88 pub. l. no. 525, 78 stat. 703; food res. & action ctr., supra note 103. 106. housing instability, healthypeople.gov, https://www.healthypeople.gov/2020/topicsobjectives/topic/social-determinants-health/interventions-resources/housing-instability#6 [https://perma.cc/26ka-phks]. 2019] the public charge rule as public health policy 193 lifeline” to recipients who are living through a national affordable housing crisis that is expected to continue growing.107 the national housing law project reports that “[h]aving safe and stable housing is crucial to a person’s good health, their ability to sustain employment, and overall self-sufficiency.”108 a body of research shows that housing instability causes increased hospital visits, mental health problems, and loss of employment, and that it negatively impacts children’s cognitive development.109 by subsidizing the cost of housing, public housing programs directly address the root cause of housing instability. public benefits that provide or subsidize the costs of health care, food, and housing work together to ensure stability for working families.110 for example, families that are able to access housing assistance and nutrition benefits are 72 percent more likely to experience housing stability.111 similarly, individuals with access to affordable health coverage are 25 percent less likely to miss a rent payment.112 while each public benefit program described here has been shown to have positive impacts on public health, their combined impact is greater than their sum. together, they “serve as investments in social and individual well-being and future productivity.”113 107. nat’l housing law project, comments in response to proposed rulemaking: inadmissibility on public charge grounds 1, 3 (dec. 10, 2018), https://www.nhlp.org/wpc o n t e n t / u p lo a d s /n h lp -c om men t s -on -p roposed-r u le -on -p u blic -c h arge .pdf [https://perma.cc/l42l-a4tj]. 108. id. at 4-5. 109. see will fischer, research shows housing vouchers reduce hardship and provide platform for long-term gains among children, ctr. on budget & pol’y priorities, https://www.cbpp.org/research/housing/research-shows-housing-vouchers-reduce-hardship-andprovide-platform-for-long-term [https://perma.cc/z2cs-3clc] (last updated oct. 7, 2015); linda giannarelli et al., reducing child poverty in the us: costs and impacts of policies proposed by the children’s defense fund (jan. 2015), https://www.urban.org/sites/default/ files/publication/39141/2000086-reducing-child-poverty-in-the-us.pdf [https://perma.cc/49tmfdkf]; heather sandstrom & sandra huerta, the negative effects of instability on child development: a research synthesis (2013), https://www.urban.org/sites/default/ files/publication/32706/412899-the-negative-effects-of-instability-on-child-development-aresearch-synthesis.pdf [https://perma.cc/7mhx-7kxs]. 110. nat’l housing law project, supra note 107, at 6. 111. megan sandel et al., co-enrollment for child health: how receipt and loss of food and housing subsidies relate to housing security and statutes for streamlined, multi-subsidy application, 5 j. applied res. on child. 2, 7 (2014). 112. kriston capps, for the poor, obamacare can reduce late rent payments, citylab (dec. 4, 2018), https://www.citylab.com/equity/2018/12/obamacare-health-insurance-housing-rentpayments/577099/ [https://perma.cc/mkd3-y7pu]. 113. nat’l housing law project, supra note 107, at 10. 194 indiana health law review [vol. 16:177 b. chilling effects the nexus of immigration law and public benefits law is incredibly complex.114 confusion about which immigrant statuses qualify for which benefits is a frequent source of error at state welfare agencies.115 likewise, noncitizens themselves are often unaware of whether they qualify for various benefits,116 and whether enrolling in public benefits could have negative consequences for future immigration applications.117 proposed expansions of the types of public benefits that are considered in public charge determinations have sown confusion among noncitizens and have been associated with a marked decrease in public benefits enrollment.118 this effect is observed in noncitizens who are directly impacted by 114. see, e.g., andrew hammond, the immigration-welfare nexus in a new era?, 22 lewis & clark l. rev. 501, 503 (2018) (“mapping the unpredictable landscape of noncitizen eligibility for public benefits”); tanya booker, avideh moussavian, & jonathan blazer, overview of immigrant eligibility for federal programs, nilc, 7, https://www.nilc.org/wp-content/uploads/ 2015/12/overview-immeligfedprograms-2015-12-09.pdf [https://perma.cc/39rc-l34k] (last updated dec. 2015) (“confusion about eligibility rules pervades benefit agencies and immigrant communities. the confusion stems from the complex interaction of the immigration and welfare laws, differences in eligibility criteria for various state and federal programs, and a lack of adequate training on the rules as clarified by federal agencies.”). 115. tanya broder et al., overview of immigrant eligibility for federal programs, national immigration law center, 7 (2015), https://www.nilc.org/wp-content/uploads/2015/12/overviewimmeligfedprograms-2015-12-09.pdf [https://perma.cc/4r7j-y74q]. (“[m]any . . . eligibility workers have turned away eligible immigrants mistakenly.”); id. at 8 (describing how benefit agencies sometimes misinterpret verification requirements relating to immigration or citizenship status). there are credible reports that in the past, ins and state department officials have erroneously excluded persons from entering the united states under the public charge ground based on their usage of non-cash public assistance. claudia schlosberg & dinah wiley, the impact of ins public charge determinations on immigrant access to health care (1998). 116. broder et al., supra note 115, at 7. 117. id. (describing how “[t]he misapplication of [the] public charge ground of inadmissibility immediately after [prwora] passed contributed significantly to the chilling effect on immigrants’ access to services”). 118. see neeraj kaushal & robert kaestner, welfare reform and health insurance of immigrants, 40 health serv. res. 697 (jun. 2005), https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc1361164/ [https://perma.cc/v6p4-em44]; michael e. fix & jeffrey s. passel, trends in noncitizens’ and citizens’ use of public benefits following welfare reform, urb. inst. (mar. 1, 1999), https://www.urban.org/research/publication/trends-noncitizens-and-citizens-use-publicbenefits-following-welfare-reform [https://perma.cc/vp4p-epj3]; namratha r. kandula et al., the unintended impact of welfare reform on the medicaid enrollment of eligible immigrants, 39 health serv. res. 1509 (oct. 2004), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1361081/ [https://perma.cc/kd3z-atlm]; rachel benson gold, immigrants and medicaid after welfare reform, guttmacher inst. (may 1, 2003), https://www.guttmacher.org/gpr/2003/05/immigrantsand-medicaid-after-welfare-reform [https://perma.cc/h7n5-lzcm]; inadmissibility on public charge grounds, 83 fed. reg. 51,114 (proposed oct. 10, 2018). in its proposed rule, dhs notes 2019] the public charge rule as public health policy 195 changes in law as well as by those who are not directly impacted.119 this latter effect, in which noncitizens disenroll from or forgo enrollment in public benefits for which they qualify is called a “chilling effect.”120 uncertainty about possible consequences of enrollment in public benefits drives the chilling effect.121 members of mixed-status families (families in which members have different citizenship or immigration statuses) are particularly susceptible to the chilling effect, because although some members of the family (e.g. u.s. citizens) may qualify for benefits and are not subject to public charge, others may not be eligible or may be subject to public charge, and this complexity may discourage decision makers from applying for benefits for any member of the family.122 children are particularly at risk of negative health consequences of this chilling effect, because although noncitizen children are typically eligible for a broader array of public benefits compared with adults, their parents tend to control decisions about enrollment.123 even if parents enroll their children in public benefits but choose not to enroll themselves, any negative effects on parents’ health and well-being will inevitably impact their children.124 studies have found that early childhood exposure to “toxic stress,” or “strong, frequent, and/or prolonged adversity . . . without adequate adult support,” can interfere with brain development.125 economic that studies of the chilling effect of welfare reform in 1996 caused enrollment reductions in public benefit programs ranging from 21-54%. 119. see, e.g., samantha artiga et al., estimated impacts of the proposed public charge rule on immigrants and medicaid, kaiser fam. found., 3 (2018), http://files.kff.org/attachment/issuebrief-estimated-impacts-of-the-proposed-public-charge-rule-on-immigrants-and-medicaid [https://perma.cc/2ylj-375f]. 120. see, e.g., jeanne batalova et al., chilling effects: the expected public charge rule and its impact on legal immigrant families’ public benefits use, migration pol’y inst. (2018), https://www.migrationpolicy.org/sites/default/files/publications/proposedpublicchargerule_fin alweb.pdf [https://perma.cc/dv8w-d4hu]. 121. id. 122. see, e.g., kathleen r. page & sarah polk, chilling effect? post-election health care use by undocumented and mixed-status families, 376 new eng. j. med. e20 (2017) (describing how, post-prwora, undocumented immigrant parents declined to enroll their u.s. citizen children in public benefits because they were “reluctant to interact with staff at public agencies or to enter their information in government databases”); id. (predicting that the current “climate of deportation may dampen the use of existing resources, even among eligible people”). 123. id. 124. steven d. cohen, applying the science of child development in child welfare systems, ctr. on dev. child. harv. u., 10-11 (oct. 2016), http://www.caichildlaw.org/misc/dec2016_ rt_harvard_brief.pdf [https://perma.cc/x8ww-uyu7] (describing how parents of children who have been abused or neglected are often facing powerful external stressors, and that public assistance that helps them meet basic needs can “allow[] them to focus on longer-term priorities such as building the skills needed to care effectively for their children.”). 125. jack p. shonkoff et al., the lifelong effects of early childhood adversity and toxic stress, aap news & journals gateway, e236-37 (jan. 2012), http://pediatrics.aappublications. 196 indiana health law review [vol. 16:177 instability, food insecurity, and health problems can exacerbate toxic stress responses.126 changes in public charge law can undermine individual and population health if people who are not subject to public charge consequences refuse to apply for or disenroll from public benefits that support health, nutrition, and economic stability. for example, one common misunderstanding of public charge is that it applies when a lawful permanent resident applies for naturalization (to become a u.s. citizen). this error was reported widely in the media following the release of the proposed public charge rule in october 2018.127 even some naturalized u.s. citizens expressed concern over whether their receipt of public benefits could put their u.s. citizenship at risk. the development of public charge policy has reflected a broad public policy strategy of improving health and nutrition in order to help working-poor families become self-sufficient.128 law and policy that disincentivizes noncitizens from enrolling in public benefits is a structural determinant of health that is predicted to be extremely costly in the long term. c. public health rationale in its 1999 field guidance, ins made explicit the public health rationale underlying its interpretation of the statutory provisions establishing the public charge grounds of inadmissibility and deportability. at the outset, ins claimed that its reasons for providing this interpretation to the public were “to reduce the negative public health consequences generated by the existing confusion and to provide aliens with better guidance as to the types of public benefits that will and will not be considered in public charge determinations.”129 by “negative public health consequences,” ins meant the result of noncitizens foregoing enrollment org/content/129/1/e232 [https://perma.cc/7jgd-lp6x] (defining toxic stress); toxic stress, ctr. on dev. child. harv. u., https://developingchild.harvard.edu/science/key-concepts/toxic-stress/ [https://perma.cc/v2r7-tupp] (describing impact of toxic stress on brain architecture). 126. see, e.g., excessive stress disrupts the architecture of the developing brain, ctr. on dev. child. harv. u., 3 (jan. 2014), https://46y5eh11fhgw3ve3ytpwxt9r-wpengine.netdnassl.com/wp-content/uploads/2005/05/stress_disrupts_architecture_developing_brain-1.pdf [https://perma.cc/7d59-2svd] (“children who grow up in conditions of economic hardship often exhibit elevated stress hormone levels.”). a characteristic toxic stress response is “strong, frequent, or prolonged activation of the body’s stress management system.” id. at 2. 127. see, e.g., khushbu shah, alarmist reporting turns immigrants away from social services, officials say, colum. journalism rev. (nov. 28, 2018), https://www.cjr.org/ covering_the_health_care_fight/wic-immigrants.php [https://perma.cc/5gau-5srj]; new “public charge” rules shouldn’t affect travel plans for current permanent residents, sanctuary santa cruz (nov. 19, 2018), https://sanctuary-sc.net/cab-public-charge/ [https://perma.cc/as78br7n]. 128. inadmissibility and deportability on public charge grounds, 64 fed. reg. 101, 28,678 (1999). 129. id. at 28,689. 2019] the public charge rule as public health policy 197 in benefits due to fears of negative immigration consequences under the public charge law.130 ins was particularly concerned about noncitizens’ fears of accessing “emergency and other medical assistance, children’s immunizations, and basic nutrition programs, as well as the treatment of communicable diseases.”131 ins also noted that noncitizens were being deterred from other health-supporting benefits such as child care and transportation vouchers.132 hence, public health considerations were a motivating factor behind the standards that the ins proposed in the 1999 field guidance, which remains the current policy. iii. the proposed public charge rule as a departure from longstanding policy dhs released a proposed rule on october 10, 2018, that would dramatically alter longstanding public charge policy in the inadmissibility context.133 the intent of the proposed changes is “to better ensure that aliens subject to the public charge inadmissibility ground are self-sufficient.”134 dhs purports to do this by making the public charge test less discretionary and by expanding the number of noncitizens who would be excluded under the public charge ground.135 the rule aims to achieve some of the policy changes that the trump administration has unsuccessfully sought to implement through congress, such as limiting familybased immigration by moving to a “merit-based” immigration system.” notably, the rule would change the longstanding definitions of “public charge” and “public benefit.” the proposed definition of “public charge” would change the meaning of the term from “primarily dependent on the government” to “an alien who receives one or more public benefits.”136 in addition, the proposed rule expands the types of public benefits that would be considered in the public charge determination.137 dhs describes this change as an improvement to the current policy, which it considers to be “insufficiently protective of the public budget, particularly in light of significant public expenditures on non-cash benefits.”138 historically, the only types of public benefits that have been 130. id. 131. id. at 28,676. 132. id. at 28,677. 133. see inadmissibility on public charge grounds, 83 fed. reg. 51,114 (proposed oct. 10, 2018). 134. id. at 51,116. 135. see proposed change to public charge ground of inadmissibility, u.s. citizenship and immigr. services, https://www.uscis.gov/legal-resources/proposed-change-public-charge-groundinadmissibility/ [https://perma.cc/7pzq-4vnv] (last updated oct. 16, 2018) (stating that “there has been insufficient guidance on how to determine if an alien who is applying for a visa, admission, or adjustment of status is likely at any time to become a public charge”). 136. inadmissibility on public charge grounds, 83 fed. reg. at 51,157-58. 137. see id. at 51,159. 138. inadmissibility on public charge grounds, 83 fed. reg. at 51,164.. 198 indiana health law review [vol. 16:177 considered in the analysis are those that provide cash benefits or long-term institutionalization.139 the proposed rule would also consider use of nonemergency medicaid (with exceptions for certain disability-related services), premium and cost sharing subsidies for medicare part d, the supplemental nutrition assistance program (snap), and housing assistance such as public housing and section 8 vouchers.140 these benefit programs are vitally important for supporting health, nutrition, and economic stability among low-income households. in addition, the proposed rule provides more specific guidance on how to weigh certain factors in the “totality of the circumstances” test. one such guidance is to treat any public benefit enrollment within the previous thirty-six months as a “heavily weighed negative factor.”141 the following sections describe the predicted impact of the proposed rule on public benefits enrollment among noncitizens, summarize the ways in which the proposed rule represents a departure from longstanding public charge policy, and caution against abandoning the public health rationale that has influenced the development of public charge policy for over a century. a. predicted impact comments submitted to dhs by prominent advocacy groups in response to the proposed rule emphasize its predicted adverse effect on public health.142 a major concern is the “chilling effect” of the proposed rule, i.e. that noncitizens will be discouraged from accessing public benefits out of fear of, or confusion about, negative immigration consequences.143 research findings on the health effects of prior changes in law that chilled access to public benefits predict that the proposed rule would have a disproportionate impact on the health outcomes of single mothers, pregnant women, and children.144 the chilling effect of the 139. see supra text accompanying notes 52-55. 140. inadmissibility on public charge grounds, 83 fed. reg. at 51,164. 141. id. at 51,199-200. 142. see, e.g., cms-9922-p, patient protection and affordable care act; exchange program integrity nprm, nat’l health l. program (jan. 8, 2019), https://9kqpw4dcaw91s37kozm5jx17wpengine.netdna-ssl.com/wp-content/uploads/2019/01/2019-exchange-program-integritycomments-final.pdf [https://perma.cc/te36-t7u8]; dhs docket no. uscis-2010-0012, rin 1615-aa22, comments in response to proposed rulemaking: inadmissibility on public charge grounds, am. pub. health ass’n, 4-5 (dec. 10, 2018), https://apha.org/-/media/files/pdf/ advocacy/testimonyandcomments/181210_apha_public_charge_comments.ashx?la=en&hash=5 6a1a126fc49d31e1766368617b2284942a01b70 [https://perma.cc/7v4p-3zvk] (“the direct impact and chilling effect of this proposed rule threatens to erode decades of progress made in improving the public’s health.”). 143. dhs docket no. uscis-2010-0012, rin 1615-aa22, comments in response to proposed rulemaking: inadmissibility on public charge grounds, supra note 141. 144. paul wise et al., assessing the effects of welfare reform policies on reproductive and infant health, 89 am. j. pub. health 1514 (1999); kimberly narain et al., the impact of welfare reform on the health insurance coverage, utilization and health of low education single 2019] the public charge rule as public health policy 199 proposed rule is expected to result in dire public health consequences such as increases in maternal mortality, premature birth, low birth weight, behavioral and emotional problems among children, mental health issues, metabolism-related illnesses, and inflammatory diseases like arthritis.145 these negative health outcomes are expected to cause disproportionate harm to people of color, exacerbating existing disparities in health outcomes.146 for some, fear of accessing public benefits arises from confusion about who the current or proposed public charge policy affects, or which benefits are considered in the public charge determination process. media reports and anecdotal evidence support the claim that confusion is the source of a decrease in enrollment in public benefit programs by applicants for naturalization, by ineligible parents on behalf of their u.s. citizen children, and by noncitizens of all types enrolled in programs that are not considered in the inadmissibility determination in the current or proposed rule.147 for others, however, declining to enroll in or disenrolling from public benefit programs—regardless of the impact of the current or proposed rule—may be considered a rational response to the trump administration’s pronouncements on public charge, which date back to january 2017. at that time, a draft executive order, “protecting taxpayer resources by ensuring our immigration laws promote accountability and responsibility,” was leaked to the media.148 the order, which was never signed or released, directed the secretary of homeland security to rescind existing field guidance on public charge and to propose a new rule that “specifies that an alien is inadmissible as a public charge if he is likely to receive, and is deportable as a public charge if he does receive, public benefits for which eligibility or amount is determined in any way on the basis of income, resources, or financial need[.]”149 for this reason, many noncitizens reasonably anticipated a change in the rules that would penalize them for use of any meanstested public benefit. revisions to the department of state’s foreign affairs manual in january 2018 reflected the policy preferences in the executive order mothers, 180 soc. sci. & med. 28 (2017). 145. cms-9922-p, patient protection and affordable care act; exchange program integrity nprm, supra note 141, at 57-61. 146. id. at 63-65. 147. see, e.g., helena bottemiller evich, immigrants, fearing trump crackdown, drop out of nutrition programs, politico, https://www.politico.com/story/2018/09/03/immigrants-nutritionfood-trump-crackdown-8062922 [https://perma.cc/676b-2d34] (last updated sept. 4, 2018, 1:29 pm. 148. see, e.g., matthew yglesias & dara lind, read leaked drafts of four white house executive orders on muslim ban, end to dreamer program, and more, vox (jan. 25, 2017, 5:43 pm), https://www.vox.com/policy-and-politics/2017/1/25/14390106/leaked-drafts-trumpimmigrants-executive-order [https://perma.cc/xb46-x5lh]. 149. memorandum from andrew bremburg, assistant to the president and dir. of the domestic policy council, to president donald trump (jan. 23, 2017), https://cdn3.vox-cdn.com/ uploads/chorus_asset/file/7872571/protecting_taxpayer_resources_by_ensuring_our_immigr ation_laws_promote_accountability_and_responsibility.0.pdf [https://perma.cc/c3kd-spap]. 200 indiana health law review [vol. 16:177 by permitting its officials abroad to consider use of all public benefits by applicants or their dependent family members in public charge assessments.150 in february and march 2018, two drafts of a public charge rule were leaked to the media; both drafts carried out the directive of the draft executive order to consider use of any means-tested public benefit in the public charge assessment.151 both drafts also included use of public benefits by applicants’ dependent family members, including u.s. citizen children.152 these periodic releases of information, although questionably reliable, were in line with the trump administration’s stated policy goal of reducing noncitizen enrollment in public benefit programs. with this background, one can understand why a noncitizen who is not subject to the current or proposed public charge policy would choose to avoid the use of public benefits. there is a rational fear among noncitizens that public charge policy could become more punitive over time or could be applied retroactively. dhs acknowledges the possibility that its proposed rule could chill immigrant enrollment in public benefits: research shows that when eligibility rules change for public benefits programs there is evidence of a “chilling effect” that discourages immigrants from using public benefits programs for which they are still eligible . . . [i]t is unclear how many individuals would actually disenroll from or forego enrollment in public benefits programs due to the proposed rule . . . prwora was directly changing eligibility requirements whereas this proposed rule, if finalized, would change enrollment incentives.153 if the proposed rule is finalized as written, noncitizens who will have to undergo a public charge determination in the future will certainly be incentivized to refrain from enrolling in certain benefits. this will be a difficult decision for some families, as the american public health association notes in its public comment submitted in response to the proposed rule: “the fear generated by this rule would put families in impossible situations where they are forced to choose between keeping their families together or enrolling in programs to keep their families healthy.”154 however, dhs fails to recognize that noncitizens who are 150. access to health care, food, and other public programs for immigrant families under the trump administration, nat’l immigr. l. ctr. (mar. 22, 2017), https://www.nilc.org/ issues/health-care/exec-orders-and-access-to-public-programs/ [https://perma.cc/l6z7-p2bn]. 151. id. 152. id. 153. inadmissibility on public charge grounds, 83 fed. reg. at 51,266 (emphasis added). 154. comment letter on proposed rulemaking: inadmissibility on public charge grounds from georges c. benjamin, executive director of the american public health association, to samantha deshommes, chief of the regulatory coordination division of the office of policy and strategy at u.s. citizenship and immigration services, department of homeland security, at 2 (dec. 10, 2018), https://apha.org/-/media/files/pdf/advocacy/testimonyandcomments/181210_ apha_public_charge_comments.ashx [https://perma.cc/e26z-t56l]. 2019] the public charge rule as public health policy 201 not subject to public charge inadmissibility would also be chilled from enrolling in benefits.155 it is estimated that if the proposed public charge role is finalized as written, the magnitude of disenrollment caused by the chilling effect would dwarf the number of noncitizens who are actually subject to public charge inadmissibility.156 for example, disenrollment from medicaid and the children’s health insurance program on account of the proposed rule is estimated to be between 2.1 and 4.9 million.157 this includes as many as two million eligible u.s. citizen children with immigrant parents who disenroll out of fear of immigrationrelated consequences.158 more tragically, it is possible that even if the proposed public charge rule is never finalized as written, its major effect will be to have chilled public benefits use for millions of noncitizens. a chilling effect has already been observed in response to leaked drafts of the proposed public charge rule.159 there are widespread reports of noncitizens avoiding public benefits use out of fear of immigration consequences.160 155. see, e.g., comment letter on inadmissibility on public charge grounds from elizabeth g. taylor, executive director of the national health law program, to u.s. citizenship and immigration services, department of homeland security, at 44 (dec. 10, 2018), https:// 9kqpw4dcaw91s37kozm5jx17-wpengine.netdna-ssl.com/wp-content/uploads/2018/12/nationalhealth-law-program-public-charge-comments-final-12.10.18.pdf [https://perma.cc/j8sd4pvk] (nhelp stating “dhs wrongly ignores the fact that family members and communities surrounding noncitizens will stop using public benefits, even though they are not directly targeted by the proposed rule.”). 156. see, e.g., id. at 44 (estimating that “[t]he proposed rule will directly affect approximately 1.1 million individuals seeking to obtain lawful permanent resident (lpr) status” compared with potentially “14 million noncitizens and their family members whose household incomes fall below 125 percent of [federal poverty guidelines].”). 157. artiga et al., supra note 5. 158. samantha artiga et al., potential effects of public charge changes on health coverage for citizen children (henry j. kaiser family foundation, 2018), http://files.kff.org/attachment/issue-brief-potential-effects-of-public-charge-changes-on-healthcoverage-for-citizen-children [https://perma.cc/xm9r-qqgp]. 159. see, e.g., evich, supra note 146; taylor, supra note 154. 160. see, e.g., mitchell h. katz & dave a. chokshi, the “public charge” proposal and public health implications for patients and clinicians, jama (oct. 1, 2018) https:// championprovider.ucsf.edu/sites/champion.ucsf.edu/files/wysiwyg/jama%20the%20public% 20charge%20proposal%20katz%2c%20m%202018.pdf [https://perma.cc/rrl9-hsjd]; evich, supra note 146; ileana najarro & jenny deam, fearing deportation, undocumented immigrants in houston are avoiding hospitals and clinics, houston chronicle, https://www. houstonchronicle.com/news/houston-texas/houston/article/fearing-deportation-undocumentedimmigrants-are-12450772.php [https://perma.cc/4duq-jprv] (last updated dec. 28, 2017, 11:00 a.m.). 202 indiana health law review [vol. 16:177 b. disregard for public health rationale the proposed rule is premised on one of the dual principles that have endured for more than a century of public charge policy: the desire to attract and retain immigrants who will be self-sufficient through employment.161 however, in drafting the rule, dhs ignored a critical insight that also has influenced the development of public charge policy. this is the understanding that public benefits play an important role in helping the working poor to become selfsufficient in the long term by addressing sdoh, such as access to health care and adequate nutrition. the development of public charge policy has historically reflected a broad public policy strategy of improving health and nutrition in order to help working-poor families become self-sufficient.162 one indication of dhs’s oversight is the proposed change to the definition of public charge, which shifts the focus of the analysis from dependence on government support (“primarily dependent”) to any use of public benefits (“receives one or more public benefits”).163 the proposed rule states that enrollment in benefits “even in a relatively small amount or for a relatively short duration would in many cases be sufficient to render a person a public charge.”164 this statement is inconsistent with historical understandings of dependence in the public charge context and ignores evidence indicating the contributing role of public benefits to long-term self-sufficiency. mere use of public benefits, divorced from any analysis of the degree to which such use indicates a need for long-term support, has never been a focal point of the public charge analysis. receipt of health-supporting public benefits has been understood to supplement the basic needs of working poor families and support them on the path to selfsufficiency.165 as a result, in the inadmissibility context, use of public benefits is one factor in the “totality of circumstances” test—a factor that is possible to overcome if other evidence, such as employment history, indicates that the applicant is not likely to become primarily dependent on the government for support.166 similarly, the proposed rule’s inclusion of a broad array of public benefits in the public charge determination disregards the connection between public benefits, improved health, and long-term self-sufficiency by stating that use of 161. see historians’ comment passim, supra note 10. 162. inadmissibility and deportability on public charge grounds, 64 fed. reg. 28, 676, 28, 678. (may 26, 1999). 163. inadmissibility on public charge grounds, 83 fed. reg. at 51,157-58. 164. inadmissibility on public charge grounds, 83 fed. reg. at 51,164. this statement is inconsistent with historical understandings of dependence in the public charge context and ignores evidence indicating the contributing role of public benefits to long-term self-sufficiency. 165. field guidance on deportability and inadmissibility on public charge grounds, 64 fed. reg. at 28, 692. 166. application for adjustment from temporary to permanent resident status, 8 c.f.r. § 245a.3(g)(4)(i)-(iii) (2019). 2019] the public charge rule as public health policy 203 virtually any public benefit “evidence[s] a lack of self-sufficiency.”167 dhs correctly notes that “[f]ood, shelter, and necessary medical treatment are basic necessities of life.”168 however, it then jumps to the conclusion that “[a] person who needs the public’s assistance to provide for these basic necessities is not selfsufficient.”169 this conclusion relies on dhs’s definition of “self-sufficient,” which refers to those who “do not depend on public resources to meet their needs, but rather rely on their own capabilities and the resources of their family, sponsor, and private organizations.”170 this tautological reasoning ignores the substantial evidence, upon which the ins relied in its 1999 field guidance, that people with a broad range of incomes receive public benefits to subsidize basic necessities in order to maintain good health and achieve self-sufficiency: “certain federal, state, and local benefits are increasingly being made available to families with incomes far above the poverty level, reflecting broad public policy decisions about improving general health and nutrition, promoting education, and assisting working-poor families in the process of becoming self-sufficient.”171 the aca represents the latest manifestation of this trend of expanding eligibility for public benefits to a broader swath of families on the income spectrum. its premium subsidy for coverage purchased in the health insurance marketplace is available to households with resources up to 400 percent of the federal poverty line.172 this reform addresses inefficiencies in the health insurance market that would otherwise make health insurance unaffordable. in the proposed rule, dhs acknowledges that its changes will likely cause great harm to individuals, families, and communities.173 specifically, it states that disenrollment and foregone enrollment in public benefits will likely lead to: • worse health outcomes, including increased prevalence of obesity and malnutrition, especially for pregnant or breastfeeding women, infants, or children, and reduced prescription adherence; • increased use of emergency rooms and emergent care as a method of primary health care due to delayed treatment; • increased prevalence of communicable diseases, including among members of the u.s. citizen population who are not vaccinated; • increases in uncompensated care in which a treatment or service is not paid for by an insurer or patient; • increased rates of poverty and housing instability; and 167. inadmissibility on public charge grounds, 83 fed. reg. 51,114, 51,159 (oct. 10, 2018) (to be codified at 8 c.f.r. pts. 103, 212, 213, 214, 245 and 248) (dhs proposes that some shortterm or very small dollar amount of benefits may be excluded from public charge determinations). 168. id. at 51,159. 169. id. 170. id. at 51,122. 171. inadmissibility and deportability on public charge grounds, 64 fed. reg. at 28,678. 172. internal revenue service, eligibility for the premium tax credit, https://www.irs.gov/ affordable-care-act/individuals-and-families/eligibility-for-the-premium-tax-credit [https://perma.cc/5b2b-fek9] (last updated feb. 14, 2019). 173. inadmissibility on public charge grounds, 83 fed. reg. at 51,270. 204 indiana health law review [vol. 16:177 • reduced productivity and educational attainment.174 despite acknowledging these explicit harms, and “the importance of increasing access to health care and helping people to become self-sufficient in certain contexts (such as respect to other agencies’ administration of government assistance programs),” dhs concludes that it is not required to advance those goals through public charge policy.175 however, this statement is explicitly counter to its predecessor agency’s interpretation of the decades-long history of public charge policy. moreover, it devalues larger developments in social welfare and public health policy that have sought to improve access to health care and health-supporting public benefits among all members of the community, and specifically for vulnerable members of the community. such policies, which increase government spending on public benefits, are justified by their net economic benefits for society. the proposed rule reflects a divergent agenda, devoted to slashing enrollment in health-supporting public benefits among citizens and noncitizens alike in the name of “self-sufficiency.” this broader agenda is evident in an executive order signed by president trump in april 2018, which announced policy support for strengthening work requirements in programs across the welfare system.176 the center for medicare & medicaid services (cms) had already taken this position, releasing policy guidance in january 2018 to support state efforts to impose work or community engagement (volunteer) requirements as a condition of medicaid eligibility.177 cms’s policy guidance grossly misinterprets the relationship between public benefits, health outcomes, and self-sufficiency. it justifies its position based on studies indicating that employment and community engagement are correlated with improved health outcomes.178 however, researchers have cautioned against drawing the conclusion that work requirements would help to improve health and well-being among medicaid beneficiaries; this is because correlation does not imply causation and evidence on the effect of employment 174. id. 175. id. at 51,158, n. 258. 176. executive order reducing poverty in america by promoting opportunity and economic mobility, 83 fed. reg. 15941 (apr. 10, 2018). the u.s. department of agriculture (usda) had already begun reviewing its options for stricter work requirements for recipients of snap on the date that the executive order was signed. in february 2019, usda proposed a rule to broaden its work requirement, with the goal of “moving more able-bodied recipients of [snap] benefits to self-sufficiency through the dignity of work.” proposed rule: snap requirements for able-bodied adults without dependents, usda, https://www.fns.usda.gov/snap/fr-020119 [https://perma.cc/ z4n7-ukdj]. 177. letter from brian neale, deputy administrator and director, center for medicaid and chip, to state medicaid directors (jan. 11, 2018), https://www.medicaid.gov/federal-policyguidance/downloads/smd18002.pdf [https://perma.cc/2kky-ysws]. support for work requirements in medicaid represents a major shift in policy, as cms had rejected state requests to impose such requirements in the past. id. at 3. 178. id. at 2, 3, 7. 2019] the public charge rule as public health policy 205 on health is limited.179 there is much stronger evidence relating to the opposite effect: that access to subsidized health insurance such as medicaid enables low-wage workers to obtain and retain employment.180 research consistently shows that medicaid enrollment is associated with “improved financial well-being, not a lack of selfsufficiency.”181 indeed, medicaid enrollment “produces net positives for the public budget over time both by increasing revenue collection and by decreasing government expenditures for incomes supports and costs of delayed and uncompensated care”—a conclusion that contrasts sharply with the cost-cutting rationale used to justify the administration’s proposed policies in the immigration and welfare contexts.182 in addition, experts in poverty law and policy have strongly denounced work requirements in welfare programs, characterizing them as “ill-informed, ineffective, inefficient, and inequitable.”183 nevertheless, as of january 2019, sixteen states have applied to the secretary of health and human services (hhs) for section 1115 medicaid demonstration waivers that would permit them to condition medicaid on meeting a work requirement.184 one state, arkansas, has implemented its work requirement, and an early analysis shows that few people obtained new jobs and many people lost their health insurance as a result of the requirement.185 in march 2019, judge james e. boasberg of the u.s. district court for the district of columbia ruled against the secretary’s approval of work requirements in arkansas and kentucky in two separate opinions and halted the implementation of the work requirement in arkansas.186 in both cases, the court found that the secretary failed to address the programs’ potential to cause substantial numbers of people to lose their health 179. see, e.g., larisa antonisse and rachel garfield, the relationship between work and health: findings from a literature review (henry j. kaiser family foundation, 2018), http://files.kff.org/attachment/issue-brief-the-relationship-between-work-and-healthfindings-from-a-literature%20review [https://perma.cc/z754-jzxn]; heather hahn et al., work requirements in social safety net programs (urban institute, 2017) https://www. urban.org/sites/default/files/publication/95566/work-requirements-social-safety-net-programs_4.pdf [https://perma.cc/hmb8-klsh]. 180. antonisse & garfield, supra note 177. 181. taylor, supra note 154, at 10. 182. id. at 12. 183. see, e.g., grant et al., unworkable & unwise: conditioning access to programs that ensure a basic foundation for families on work requirements (georgetown center on poverty and inequality, 2019) http://www.georgetownpoverty.org/wp-content/uploads/2019/ 02/unworkable-unwise-20190201.pdf [https://perma.cc/p7zp-qvem]. 184. id. at 11. 185. an early look at the impact: new medicaid work requirement hurts health coverage in arkansas 3 (arkansas advocates for children & families, 2018), http://www. aradvocates.org/publications/medicaid-work-requirement-arkansas-hurts-health-coverage/ [https://perma.cc/dhz6-gtna]. 186. gresham v. azar, 363 f. supp. 3d 165 (d.c. cir. 2019); stewart v. azar (“stewart ii”), 2019 wl 1375496 (d.c. cir.). 206 indiana health law review [vol. 16:177 coverage.187 this effect would contradict the main purpose of medicaid, which is to provide medical assistance to people who cannot afford it.188 significantly, in both opinions the court explicitly recognizes the role of health coverage in promoting financial self-sufficiency. in gresham v. azar, the challenge to the approval of the arkansas works amendments, the opinion opens with the story of adrian mcgonigal, an arkansas resident who was terminated from medicaid for failure to report his employment.189 as a result, he was unable to afford his prescriptions, his health conditions flared up, he missed several days of work, and was ultimately fired by his employer because of his absences.190 in stewart ii, the court notes that even if self-sufficiency were an objective of medicaid and “some number of beneficiaries were to gain independence, the secretary does not weigh the benefits of their self-sufficiency against the consequences of coverage loss, which would harm and undermine the financial self-sufficiency of others.”191 by including medicaid among the benefits to be considered in the public charge determination, the proposed rule implicitly discourages low-wage noncitizen workers from enrolling in health benefits that can shield them from risks of job loss that are associated with untreated health care needs.192 the trump administration’s selective reading of the body of the body of evidence on the relationship between work and health suggests that its agenda is not really motivated by a long-term strategy to reduce government spending on public benefits. another reason to suspect that economic efficiency is not the true driver of the proposed public charge rule is dhs’s inclusion of federal housing assistance programs among the benefits to be considered in the public charge determination.193 dhs cites statistics on noncitizen enrollment in federal housing assistance programs to support its decision.194 however, dhs acknowledges that the statistics indicate that “noncitizen participation in these programs is currently 187. stewart ii, 2019 wl 1375496 at 14; gresham, 363 f. supp. 3d 165 at 18-20. 188. see 42 u.s.c. § 1396-1 (describing the purpose of medicaid). in approving kentucky’s waiver, the hhs secretary relied, in part, on an objective external to the program’s purpose: “financial self-sufficiency.” stewart ii, 2019 wl 1375496 at 29. the secretary did not rely on this objective in approving arkansas’ waiver, but did respond to public comments opposing the work requirements by stating that they “create appropriate incentives for beneficiaries to gain employment.” gresham, 363 f. supp. 3d 165 at 18 (quoting letter from seema verma, administrator, ctrs. for medicare & medicaid serv., to cindy gillespie, director, ark. dep’t of human serv. 5 (mar. 5, 2018)); id. at 25 (“nowhere in the secretary’s approval letter does he justify his decision based on . . . a belief that the project will help medicaid-eligible persons to gain sufficient financial resources to be able to purchase private insurance.”). 189. gresham, 363 f. supp. 3d 165 at 1-2. 190. id. 191. stewart ii, 2019 wl 1375496 at 33. 192. see antonisse & garfield, supra note 177. 193. see inadmissibility on public charge grounds, 83 fed. reg. at 51,158-9. 194. id. at 51,167. 2019] the public charge rule as public health policy 207 relatively low.”195 indeed, only 0.2% of noncitizens lived in section 8 housing, while 0.4% of noncitizens lived in other federally subsidized housing.196 through the lens that dhs has constructed in the proposed rule, these statistics should be interpreted to mean that noncitizens are generally self-sufficient in paying for housing and are therefore not responsible for significant expenditures on federal housing assistance programs. they indicate that the public funds devoted to subsidized housing are adequately protected by existing eligibility restrictions that prevent noncitizens from enrolling in these programs. nevertheless, dhs proposes to include federal housing assistance programs because “the total federal expenditure for the programs overall remains significant” and because “they relate to a basic living need (i.e., shelter).”197 indeed, the cost of administering the proposed rule would likely exceed the federal funds that would be saved by including federal housing assistance programs in the public charge determination. by hyper-focusing on noncitizen use of public benefits to the exclusion of analyses of long-term self-sufficiency and impact on public resources, the proposed rule departs dramatically from the history and purpose of public charge.198 the current administration has framed its proposed public charge rule as a way to promote self-sufficiency among noncitizens by discouraging them from enrolling in safety net programs.199 incidentally, they claim, the new policy would reduce federal and state government expenditures on public benefits.200 however, this section has described reasons to infer that economic efficiency is not a genuine motivation for the proposed public charge rule. in the context of president trump’s anti-immigrant rhetoric and the accompanying rise of nativism, the proposed rule should be considered one strand of the 195. id. 196. see id. 197. id. 198. press release, department of homeland security, dhs announces new proposed immigration rule to enforce long-standing law that promotes self-sufficiency and protects american taxpayers (sept. 22, 2018) https://www.dhs.gov/news/2018/09/22/dhs-announces-newproposed-immigration-rule-enforce-long-standing-law-promotes-self [https://perma.cc/hp86syyb]. dhs’s stated justification for the proposed rule is that the change would enable it to better carry out the congressional intent of the public charge law, which dhs secretary kirstjen nielsen describes as “promot[ing] immigrant self-sufficiency and protect[ing] finite resources” id. i have described how the proposed changes to public charge policy do not appear to be calculated to achieve these ends. if the proposed rule is finalized as written, there is an argument to be made that dhs has exceeded its rulemaking power in promulgating the public charge rule. this topic is ripe for future exploration but is beyond the scope of this essay. 199. see, e.g., 83 fed. reg. 51,116 (“dhs seeks to better ensure that aliens subject to the public charge inadmissibility ground are self-sufficient, i.e., do not depend on public resources to meet their needs.”). 200. id. at 51,122 (estimating that the changes would reduce federal and state government transfer payments by $2.27 billion annually). 208 indiana health law review [vol. 16:177 administration’s “self-deportation” policy agenda.201 self-deportation is “a variety of state-sponsored coercive removal that assigns some agency to individuals in their own departure.”202 in practice, it involves legislating and regulating to make every aspect of life difficult for noncitizens so that they “self-deport” or avoid entering the country at all.203 by restricting or discouraging access to public benefits, the proposed rule has already inflicted suffering on millions of people living in the united states. from that perspective, regardless of whether the rule is finalized as written, it has already done its job. c. the normative case the second principle underlying public charge policy is the commitment to support members of the community who fall on hard times.204 as i have written elsewhere, noncitizens living in the united states are embedded in multiple overlapping and complex networks within american society.205 the noncitizens who are most likely to be affected by the proposed public charge rule are those who are applying for adjustment to lawful permanent resident status, who have lived in the united states for several years, and who have close personal and professional ties with u.s. citizens.206 they almost certainly live among citizens, attend school with citizens, work side-by-side with citizens; they have paid taxes to fund public programs that promote the general welfare; they have family members who are citizens. in short, they would be considered members of the community by their neighbors, colleagues, classmates, and family. like many u.s. citizens, they may have fallen on hard times and relied on public benefits to supplement their income. insofar as solidarity with members of our communities is still considered a social good, and public benefits are recognized as a stepping stone to economic security rather than evidence of moral failure, public charge policy should continue to allow noncitizens to enroll in most public benefits without fear of 201. for a comprehensive history and analysis of self-deportation as a government strategy, see k-sue park, self-deportation nation (2018) (manuscript on file with author). 202. id. at 5-6. 203. see id. at 3 (quoting former alabama state representative micky hammon, who explained that h.b. 56, a law requiring police to attempt to determine a person’s legal status if they have reasonable suspicion that the person is unlawfully present, was designed “[t]o make it difficult for them to live here so they will deport themselves”). 204. see historians’ comment passim, supra note 10. 205. makhlouf, supra note 71, at 293-94 (2019). 206. in the context of noncitizen access to health care, solidarity-based arguments have certain limitations, described in detail in patricia illingworth & wendy e. parmet, the health of newcomers: immigration, health policy, and the case for global solidarity (2017). for example, such arguments tend to rely on exclusivity—in this case, seeming to favor noncitizens who have resided in the united states for longer periods. although it would be possible to extend my normative argument to noncitizens seeking admission from overseas, i do not attempt to do so here, as it is beyond the scope of this essay. 2019] the public charge rule as public health policy 209 negative immigration consequences. enabling access to health-supporting public benefits for all members of the community is not only critical for ensuring the long-term wellbeing of us all—it also embodies a moral commitment to solidarity with and compassion for the people who live among us. conclusion public charge law and policy have determined the admissibility and deportability of noncitizens ever since the federal government began comprehensively regulating immigration. public charge policy has remained remarkably consistent over time, adhering to its dual principles: an effort to promote the entry of able-bodied and employable immigrants and, importantly, a commitment to assist members of the community who fall on hard times. concern for public health has influenced the development of public charge policy over time. however, the changes to public charge policy proposed in october 2018 represent a departure from the policy’s dual principles and its consideration of public health concerns. rather, the proposed changes are tied to a broader agenda to restrict access to health-supporting public benefits generally, among citizens and noncitizens alike. indiana health law review, vol taxation and telehealth: would a telehealth exclusive facility owned by a nonprofit hospital be exempt from property tax in indiana? jackson hughes* i. introduction taxation exemption in the united states traces its roots to before the formation of our republic.1 organizations which provide charitable relief, such as hospitals, fire departments, and orphanages, were established to address a lack of direct governmental involvement in the societal issues faced by colonists.2 these organizations were designed to provide basic services to the public at large, and it is suggested that their wide popularity may have been spurred by early americans’ desires to see private efforts prevail over that of the government, out of a general fear of returning to monarchial rule.3 in turn, charitable organizations were likely able to shoulder the heavy load of social welfare that our newly founded government could not.4 in recognition of how vital these organizations have been and will continue to be in the future, the federal government allows for qualifying organizations to receive exemption from federal income taxation, and this practice has generally been followed by the states.5 section 501(c)(3) of the internal revenue code provides, in part, that a corporation “organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes . . .” is entitled to receive exemption from federal income taxation, provided that the statutory requirements and forms are properly completed and submitted.6 hospitals which organize as a charitable organization under section 501(c)(3) must satisfy several statutory and regulatory requirements to receive exemption from federal income taxation.7 however, exemption from state sales taxation varies from state to state and depends largely on whether the hospital is organized as a 501(c)(3) entity. first, charitable hospitals must satisfy the organizational and operational tests * j.d. candidate, 2023, indiana university – robert h. mckinney school of law; b.s. political science, 2018, franklin college. 1. paul arnsberger et al., a history of the tax-exempt sector: an soi perspective, stat. income bull.105, 105 (2008), https://www.irs.gov/pub/irs-soi/tehistory.pdf [https://perma. cc/pqy6-ztya]. 2. id. 3. id. 4. id. 5. id. 6. i.r.c. § 501(c)(3). 7. charitable hospitals general requirements for tax-exemption under section 501(c)(3), internal revenue serv., https://www.irs.gov/charities-non-profits/charitablehospitals-general-requirements-for-tax-exemption-under-section-501c3 [https://perma.cc/e8sc3f4t] (last updated aug. 3, 2021). 386 indiana health law review [vol. 20:385 under section 501(c)(3). these tests generally require the charitable hospitals to be organized exclusively for one or more exempt purposes demonstrated by the hospital’s organizational documentsand operate exclusively for that exempt purpose and “engage[] primarily in activities that accomplish one or more exempt purposes as specified in section 501(c)(3).”8 demonstration of such operation is not sufficiently shown by merely stating that the operation of the hospital is exclusively to promote health.9 rather, the hospital must also show that it operates to “promote the health of a class of persons that is broad enough to benefit the community,” known as the community benefits standard articulated in revenue ruling 69-545, 1969-2 c.b. 117.10 these requirements are in addition to those placed on hospitals under section 501(r), and only when all statutory and regulatory requirements are satisfied will a charitable hospital be permitted to receive exemption from federal income taxation.11 at the state level, a corporation’s exemption status from federal income taxation can generally be relied on to garner exemption from income taxation.12 a similar reliance is generally acceptable to also receive exemption from state sales tax.13 therefore, proof of federal income tax exemption status stemming from the hospital’s classification as a charitable corporation under section 501(c)(3) is generally all that is required for a hospital to receive exemption from state income and sales tax. however, reliance on section 501(c)(3) exemption status alone may not be sufficient to warrant state and local property tax exemption for a hospital, especially as applied to any additional property that it owns outside of the main facility campus. therefore, understanding whether an exempt hospital, and its additional property, is afforded exemption from state and local property taxation requires referring to state law, specifically the exemption statutes in indiana. 8. id. 9. id. 10. id.; see rev. rul. 69-545, 1969-2 c.b. 117, https://www.irs.gov/pub/irs-tege/rr69-545.pdf [https://perma.cc/4fat-k6ge], which lays out the six requirements a hospital must show to suffice the community benefit standard. 11. see i.r.c. § 501(r). 12. george e. constantine et al., the difference between nonprofit and tax-exempt status, venable (1999), https://www.venable.com/insights/publications/1999/10/the-difference-betweennonprofit-and-taxexempt-sta [https://perma.cc/bp8y-xp4m]. 13. ron barrett, sales and use tax exemptions for nonprofits, cogencyglobal (aug. 29, 2019), https://www.cogencyglobal.com/blog/sales-and-use-tax-exemptions-for-nonprofits [https://perma.cc/s7l7-pebn] (“the key to earning a sales tax exemption is being designated a charitable, tax-exempt 501(c)(3) nonprofit organization under the internal revenue code.”). 2023] taxation and telehealth 387 ii. the issue a. property tax exemption status afforded to a satellite telehealth exclusive facility owned by a nonprofit hospital under indiana law, a nonprofit hospital may receive tax exemptions from state income taxes and sales taxes.14 moreover, nonprofit hospitals, which are organized and operated to “relieve the destitute and deserving” are classified as charitable, and therefore, eligible to receive a charitable purposes tax exemption from state and local property taxation.15 however, additional property owned and operated by an exempt hospital “does not automatically receive a charitable purpose exemption” from state and local property taxation.16 as such, instead of automatically receiving the charitable purposes exemption already obtained by the main hospital facility, the other property must first satisfy one of three requirements under indiana law.17 these statutory requirements state that property tax exemption under section 16(a) does not exempt “other property that is not substantially related to or supportive of the inpatient facility of the hospital”18 unless the other property either: “(1) provides or supports the provision of charity care (as defined in ic 16-18-2-52.5), including providing funds or other financial support for health care services for individuals who are indigent (as defined in ic 1618-2-52.5(b) and ic 16-18-2-52.5(c)); or (2) provides or supports the provision of community benefits (as defined in ic 16-21-9-1), including research, education, or government sponsored indigent health care (as defined in ic 16-21-9-2).”19 in short, other property owned and operated by an exempt hospital is afforded a charitable purposes exemption from property taxation if the property substantially relates to or is supportive of the exempt hospital’s inpatient facility. if that standard cannot be met, the other property may be entitled to exemption upon proof that it provides or supports the provision of charity care or provides or supports the provision of community benefits. therefore, the issue to be determined is whether a telehealth-exclusive facility owned by an exempt nonprofit hospital would be found exempt from property taxes under indiana 14. community benefit state law profile: indiana, hilltop inst. 1, 2 (2016), https:// h i l l t op in s t i t u t e . o rg /w pcon ten t /u p loads /h cbp/h cbp_ docs /h c b p _ c b l_ in .pdf [https://perma.cc/myk4-bdge]. 15. indianapolis osteopathic hosp., inc. v. dep’t of loc. gov. fin., 818 n.e.2d 1009, 1015 (ind. t.c. 2004). 16. id. 17. see ind. code § 6-1.1-10-16(h) (1975). 18. id. 19. see id. 388 indiana health law review [vol. 20:385 code section 6-1.1-10-16. iii. background a. indiana’s approach to telehealth and the effect of covid-19 on the use of telehealth the use of telehealth services in indiana has been a long-accepted practice since the beginning of 2013.20 covid-19 greatly expanded the use of telehealth services across the country, in part due to the social distancing guidelines imposed by the cdc, with usage increasing by 154 percent in late march of 2020 compared to the same period in 2019.21 in indiana, lawmakers responded to the increased use of telehealth by expanding the application of telehealth practice to include licensed practitioners instead of only prescribers.22 furthermore, the bill prohibited medicaid from specifying originating sites and distant sites for purposes of medicaid reimbursement, which increases the scope of where a provider can be located and where a patient can be located for the purposes of medicaid reimbursement.23 prior to covid-19, the use of outpatient telehealth services was primarily aimed at increasing access to care for rural and underserved areas.24 however, due to the inability to have in-person appointments during the pandemic, many providers utilized telehealth to reach patients at home, when they previously had been seen in person.25 throughout the covid-19 pandemic, experts noted the clear benefits of telehealth in connecting patients with providers.26 its use has been embraced by both providers and patients, namely due to reduced travel and shorter waiting times.27 moreover, “[a]pproval ratings for [synchronous video telehealth] as a replacement for in-person visits are high among both patients and providers.”28 telehealth services have been on the rise in recent years, with the most-used services being direct-to-consumer (“dtc”) services from companies like teladoc, mdlive, and amwell.29 telehealth services appear to be here to stay, 20. see s.b. 554, 118th gen. assemb., 1st reg. sess. (ind. 2013). 21. lisa m. koonin et al., trends in the use of telehealth during the emergence of the covid-19 pandemic — united states, january–march 2020, 69 morbidity & mortality wkly. rep. 1595, 1599 (2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6943a3.htm# [https:// perma.cc/6ncm-6byn]. 22. see s.b. 3, 122nd gen. assemb., 1st reg. sess. (ind. 2021). 23. id. 24. joshua j. brotman & robert m. kotloff, providing outpatient telehealth services in the united states, 159 chest 1548, 1555 (2021). 25. id. 26. id. 27. id. 28. id. 29. id. 2023] taxation and telehealth 389 in some capacity. this is not limited to dtc companies but including health care providers at for-profit and nonprofit hospitals , with many experts predicting a notable increase in the use of telehealth services following the pandemic.30 but what if a provider wanted to provide telehealth services in a new way? specifically, at the conclusion of the pandemic – when in-person visits and normal provider-patient interactions can fully return – what if a nonprofit hospital decided to open a telehealth-exclusive facility in a rural, medically underserved area? looking outside of any health policy specific questions which would arise from such a proposal, would such a facility be exempt from property taxes under indiana law? to find an answer, let us consider a hypothetical facility. b. a hypothetical facility consider a hypothetical facility (“facility”) located in a medically underserved area. factoring out areas that are categorized as medically underserved with a governor’s exception, indiana has 46 fully and partially medically underserved areas.31 the facility also will be in a rural health area, as it would be designed to connect those in the underserved population with providers located at the main hospital. utilizing the health resources & services administration (“hrsa”) data warehouse, indiana has a total of 24 medically underserved areas located in rural areas of the state.32 each area is assigned an index of medical underservice (“imu”) score between 0 and 100, with 0 representing the most need and 100 representing the least need.33 an area is classified as medically underserved based on designation criterion developed by hrsa’s bureau of health workforce, and a score of less than or equal to 62 is needed to qualify for designation as a medically underserved area.34 organized from lowest imu score to highest imu score, the median score was 57.2, which corresponds to the cass county service area.35 therefore, the hypothetical facility will be in the cass county service 30. see tania elliot & margot c. yopes, direct-to-consumer-telemedicine, 7 j. allergy & clinical immunology: in pract. 2546, 2553 (2019) (“most us health institutions and hospital systems are currently using some form of telehealth, and more than 90% of health care executives surveyed across the united states have virtual care on their roadmap for growth.”); see also cara murez, health care after covid: the rise of telemedicine, u.s. news (jan. 5, 2021, 8:49 am), https://www.usnews.com/news/health-news/articles/2021-01-05/health-care-after-covid-the-rise-oftelemedicine (innovative approaches to health care through increased use of telehealth and telemedicine are “likely to linger long after the pandemic ebbs”). 31. mua find, health res. & serv. admin., https://data.hrsa.gov/tools/shortage-area/muafind [https://perma.cc/4yky-qkpb] (last visited oct. 14, 2021). 32. id. 33. id. 34. id. 35. id. (the lowest score (highest need) is 0; the highest score (lowest need) is 100. in order to qualify for designation, the imu score must be less than or equal to 62.0. the score applies to the mua or mup as a whole, and not to individual portions of it.). 390 indiana health law review [vol. 20:385 area because it is a medically underserved area located in a rural county. around 90.6 percent of cass county citizens are insured, breaking down to 50.5 percent covered by employee plans, 15.1 percent covered by medicaid, 13.1 percent covered by medicare, 10.6 percent are on non-group plans, and 1.26 percent are on va plans.36 moreover, the ratio of patients to primary care physicians is 2,370 to 1, which strains provider resources and access to care for citizens.37 locating a telehealth-exclusive facility that connects patients in this service area with providers at the main hospital facility will likely result in decreased wait times for in-person visits to area hospitals, increase access to care for cass county citizens, and help reduce the spread of diseases and viruses, such as the flu and covid-19. one of the main barriers to the success of telehealth services is the lack of broadband access in rural areas.38 however, assume that the facility contemplated here would limit connectivity issues by having its own facility in the underserved area that individuals could travel to and be seen virtually by a provider. but, even if such a facility would benefit this underserved area, the desirability of the investment by a nonprofit hospital would be affected by the potential unavailability of property tax exemption for the facility. specifically, the difficulty of showing how a facility located off a hospital’s main campus is substantially related to or supportive of the hospital’s inpatient facility, along with the heightened standard imposed by the indiana tax court’s recent ruling regarding the “predominate use test” to determine charitable care and community benefit,39 could deter nonprofit hospitals from establishing a telehealth facility that is easily accessible to rural hoosiers because of potential property tax exposure. 36. cass county, data usa, https://datausa.io/profile/geo/cass-county-in [https://perma. cc/3tt2-84am] (last visited oct. 12, 2021). 37. indiana, cnty. health ranking & roadmaps, https://www.countyhealthrankings. org/app/indiana/2021 [https://perma.cc/f8yv-tawm] (last visited oct. 14, 2021). 38. see victoria bailey, limited broadband poses a significant barrier to telehealth access, mhealth intel (aug. 6, 2021), https://mhealthintelligence.com/news/limited-broadband-poses-asignificant-barrier-to-telehealth-access [https://perma.cc/ea26-eqn4] (“while telehealth can offer the convenience of receiving care at home, individuals living in rural areas are at a significant disadvantage due to the lack of broadband connectivity.”). 39. indiana tax court denies property tax exemption of off-campus medical office building, hall render (dec. 3, 2019), https://www.hallrender.com/2019/12/03/indiana-tax-courtdenies-property-tax-exemption-of-off-campus-medical-office-building/ [https://perma.cc/4vd2xw2f]. 2023] taxation and telehealth 391 iv. analysis of indiana statutes and case law dealing with property tax exemptions for additional property owned by nonprofit hospitals a. hospital exemptions: indiana code §§ 6-1.1-10-16(a), (h) in indiana, all or part of a building is entitled to exemption from property tax if it is “owned, occupied, and used by a person for . . . charitable purposes.”40 in order to be entitled to a charitable purposes exemption, there must be an expectation of some benefit that flows to the public because of that exemption.41 under indiana property tax statutes, the term charity is given the broadest constitutional definition allowed.42 however, other property owned by an exempt hospital does not automatically receive a charitable purposes exemption.43 “indeed, the charitable purposes exemption does not apply to other property owned by a hospital ‘that is not substantially related to or supportive of [its] inpatient facility[.]’”44 therefore, in order for other property owned by an exempt hospital to be entitled to a charitable purposes exemption under indiana code section 6-1.1-1016(a), the property must first satisfy the substantially related to or supportive of standard in indiana code section 6-1.1-10-16(h), and the hospital must demonstrate that the other property is used for a charitable purpose. b. indiana case law regarding other property owned by an exempt hospital and the substantially related to or supportive of standard in indianapolis osteopathic hospital inc. v. department of local government finance, the indiana tax court addressed what it meant for other property to substantially relate to or support the owning exempt hospital’s inpatient facility. in that case, the health institute of indiana (“hii”) owned a 158,000 square foot facility on the campus of westview hospital.45 74 percent of the facility was used as a healthplex, “59% of the time as a community-oriented fitness facility” and “the remaining 41% of the time to provide outpatient rehabilitation services, research, and community education.”46 accordingly, the other 26 percent of the facility was used as a medical pavilion (“mp”).47 around 11 percent of the mp was leased to physicians employed by westview hospital, and 37 percent of the space in the mp was “used by various westview hospital 40. see ind. code § 6-1.1-10-16(a) (2021). 41. see indianapolis osteopathic hosp., inc. v. dep’t of loc. gov’t fin., 818 n.e.2d 1009, 1014 (ind. t.c. 2004). 42. see indianapolis elks bldg. corp. v. state bd. of tax comm’rs, 251 n.e.2d 673, 682 (ind. ct. app. 1969). 43. indianapolis osteopathic hosp., inc., 818 n.e.2d at 1015. 44. id. (quoting ind. code § 6-1.1-10-16(h)). 45. id. at 1011. 46. id. at 1012. 47. id. at 1011. 392 indiana health law review [vol. 20:385 departments, including physical and occupational therapy, mri, mammography, integrated medicine, and patient registration; and 44% of the facility was vacant.”48 additionally, around 1 percent of the facility was used as a boardroom, which was used 98 percent of the time by westview and another hospital for administrative purposes, as well as various other nonprofit community groups.49 hii and westview argued that the healthplex portion of the facility was entitled to 100 percent exemption from property tax and that the mp portion of the facility was entitled to 91 percent exemption from property tax.50 the court began its analysis by first explaining the charitable purposes exemption under indiana code section 6-1.1-10-16(a). the court explained that when a charitable purposes exemption is sought, the entity seeking the exemption must “not only demonstrate that it owns, occupies, and uses its property for a charitable purpose, but also that the charitable purpose is the property’s predominant use.”51 then, because the facility in question was other property owned by westview–and therefore subject to the substantially related to and supportive of standard under indiana code section 6-1.1-10-16(h)–the court discussed the relevance of the predominant use test to the issue before it. in 1983, the indiana legislature adopted the predominant use test to determine whether a property qualifies for exemption under indiana code section 6-1.110.52 the predominant use test is codified by statute under indiana code section 6-1.1-10-36.3, which states in relevant part: “[p]roperty is predominantly used or occupied for one or more stated purposes if it is used or occupied for one or more of those purposes during more than fifty percent (50%) of the time that it is used or occupied in the year that ends on the assessment date of the property.”53 the statute goes on to say that “[i]f a section of this chapter states one (1) or more purposes for which property must be used or occupied in order to qualify for an exemption, then the exemption applies as follows: (1) property that is exclusively used or occupied for [a charitable] purpose[] is totally exempt[.]”54 turning to the arguments presented by hii and westview, determining whether the healthplex portion of the facility–through promoting health by physical activity–constituted a charitable purposes exemption from property tax was an issue of first impression for the court.55 ultimately, the indiana court of appeals found a tennessee court of appeals decision to be informative, which acknowledged that while “such centers often have strong medical philosophies, employing physicians and exercise physiologists and offering programs tailored expressly for hospital inpatients and outpatients, they are, nonetheless, not limited 48. id. at 1013. 49. id. at 1011. 50. id. at 1016. 51. id. at 1014. 52. id. at 1019 (quoting state bd. of tax comm’rs v. new castle lodge # 147, loyal order of the moose, inc., 765 n.e.2d 1257, 1259 (ind. 2002)). 53. ind. code § 6-1.1-10-36.3(a) (1983). 54. ind. code § 6-1.1-10-36.3(b) (1983). 55. indianapolis osteopathic hosp., inc., 818 n.e.2d at 1017. 2023] taxation and telehealth 393 to use by those requiring ‘traditional’ medical care.”56 the court adopted this portion of the holding in middle tennessee medical center as its own, and consequently affirmed the indiana tax board’s denial of a charitable purposes exemption for the healthplex portion of the facility.57 regarding the mp portion of the facility, the court disagreed with the indiana tax board’s finding that while “the only portion of the mp eligible to receive an exemption was the [37%] portion used by various westview hospital departments,[that portion] did not meet the predominant use test.”58 instead, the court found the record showed that “37% of the space in the mp is used 100% of the time by various westview hospital departments, [and] the boardroom is predominantly used (i.e., 98% of the time) for hospital administrative meetings.”59 the court then determined that because “the charitable purposes exemption may apply to all or part of another building owned by a hospital if it is substantially related to or supportive of [its] inpatient facility[,]”cite the health pavilion was entitled to a 38 percent exemption because the use of that percentage of the facility by the westview hospital departments and for hospital administrative meetings, both of which constituted a substantial relation to westview’s inpatient facility.60 the court’s map to providing a charitable purposes exemption in indianapolis osteopathic hospital was because the 37 percent portion of the health pavilion that was used by westview hospital departments was substantially related to or supportive of westview’s inpatient facility. so, because that portion was used 100 percent of the time by those departments, it was predominately used for a charitable purpose, and thus, entitled to a charitable purpose exemption.61 three years after indianapolis osteopathic hospital, the court was faced with another charitable purposes exemption issue in methodist hospitals, inc. v. lake county property tax assessment board of appeals. there, the court determined whether two primary care associates medical offices (“pca”), owned by methodist hospital, qualified for a charitable purposes property tax exemption.62 methodist hospital owned and operated two acute care hospitals located in gary, indiana (northlake campus) and the other in merrillville, indiana 56. id. (quoting middle tenn. med. ctr. v. assessment appeals comm’n state of tenn., no. 01a01-9307-ch-00324, 1994 wl 32584, at *4 (tenn. ct. app. 1994)). 57. indianapolis osteopathic hosp. inc., 818 n.e.2d at 1018. 58. id. at 1017. 59. id. at 1019. 60. id. 61. it would follow that the same analysis from the court in indianapolis osteopathic hospital would be used for the boardroom portion of the facility and its use (98 percent of the time) for hospital administrative meetings, thereby totaling the exemption to 38 percent. 62. methodist hosp.’s, inc. v. lake cnty. prop. tax assessment bd. app., 862 n.e.2d 335 (ind. t.c. 2007). 394 indiana health law review [vol. 20:385 (southlake campus).63 in addition to these primary facilities, methodist hospital also owned two pca offices, one located in griffith, indiana and the other in merrillville, indiana–which was located on the southlake methodist campus. the pcas employed both physicians and other staff members who were employees of methodist hospital and were used as primary care medical offices.64 the onsite physicians at the pcas specialized in obstetrics/gynecology, pediatrics, internal medicine, and family medicine.65 residents in the area surrounding the pca offices would “seek out the medical services offered at the pcas from monday through saturday, but methodist did not send patients to the pcas.66 however, the pca physicians were able to admit the patients seen at the pcas to methodist’s acute care hospitals and treat inpatients at the main hospital.67 methodist hospital also performed all the billing and collection work for the pca offices, depositing the payments from patients for services rendered at the pca offices “into the same bank account it uses for its acute care hospitals.”68 methodist argued that the pca facilities were entitled to a property tax exemption: “(1) because it uses the pcas to provide traditional medical services, (2) because the pcas provide medical services as a part of methodist’s “overall continuum of care[,]” and (3) because the pca physicians do not use the offices “for personal gain.”69 the court began by discussing indiana code section 6-1.1-10-16(a)’s charitable purposes exemption and indiana code section 6-1.1-10-16(h)’s limitation of automatic exemption for other property owned by exempt hospitals. next, in order to determine whether the standard under section 16(h) was satisfied, the court had to establish: “a) what is a hospital’s inpatient facility; and b) what does it mean to be ‘substantially related to or supportive of’ a hospital’s inpatient facility?”70 this was done by attributing “the plain, ordinary, and usual meaning of non-technical words in a statute [as] defined by their ordinary and accepted dictionary meaning.”71 the court found that it was “clear from the language used in indiana code § 6-1.1-10-16(h) that an inpatient facility is not an entire hospital, but only a portion of a hospital.”72 the term “inpatient” is defined according to webster’s dictionary as “a patient in a hospital or infirmary who receives lodging and food as well as treatment.”73 the term “facility” is similarly defined as “something . . . that is built, constructed, installed or established to perform 63. id. at 336. 64. id. 65. id. at 340 n.2. 66. id. at 336. 67. id. 68. id. 69. id. at 339. 70. id. at 338. 71. id. 72. id. at 339. 73. id. (quoting inpatient, webster third new international dictionary (3d ed. 2002). 2023] taxation and telehealth 395 some particular function or to serve or facilitate some particular end[.]”74 therefore, the court defined an inpatient facility as a “portion of a hospital where admitted patients are provided overnight accommodations, meals, and medical treatment.”75 the court applied the same form of analysis to define substantial, related, and support, concluding that standard under section 16(h) meant “the other property is associated, to a considerable degree, to a hospital’s inpatient facility or that the other property provides considerable aid to, or promotes to a considerable degree, the interests of a hospital’s inpatient facility.”76 taking the construction of the statutory language and applying it to the facts, the court disagreed with all three of methodist’s arguments. the court began its analysis by finding that evidence showing that methodist “employs those who work at the pcas, bills pca patients, and performs other banking and administrative functions on behalf of the pcas” failed to establish a clear relationship between the pca facilities methodist’s inpatient facility and likewise failed to show “how the pcas promote the overall interests of methodist’s inpatient facility.”77 moreover, the court held evidence showing that the pca facilities provided medical services to individuals from “[a]ll over the entire region and admit[ed] pca patients into methodist’s hospitals” only demonstrated that the pca facilities offered those services; which, by itself failed to show how the pca facilities were “substantially related to or supportive of methodist’s inpatient facilities.”78 the court also held that the evidence showing the physicians at the pcas did not use the offices for personal gain did “little to expose what relationship or degree of support exists between the pcas and methodist’s inpatient facilities.”79 however, the court did state that evidence of pca physicians providing medical care to methodist’s inpatients demonstrated “some relationship or degree of support” between the pcas and methodist’s inpatient facilities, but because the record also showed that pca physicians provided medical care “substantially, to the general public,” the court declined to find that the pca facilities were “substantially related to or supportive of methodist’s inpatient facilities.”80 in its conclusion that the pca facilities were not entitled to a charitable purposes property tax exemption, the court seemed to suggest sufficient evidence would have shown that the pca facilities were “substantially used to provide medical 74. id. (quoting facility, webster third new international dictionary (3d ed. 2002). 75. id. 76. id. 77. methodist hosp.’s., inc. v. lake cnty. prop. tax assessment bd. app., 862 n.e.2d 335, 339 (ind. t.c. 2007). 78. id. at 338. (“in other words, this court will not presume that a substantial relationship or supportive network arises merely because two entities are engaged in the same type of business activity.”) 79. id. at 340. 80. id. 396 indiana health law review [vol. 20:385 care to methodist’s inpatients.”81 here, it seems that the court’s map to denying a charitable purposes exemption for the pca facilities centered on the insufficiency of the evidence in showing that: (1) the pcas were considerably associated with or provided considerable aid to methodist’s inpatient facility, and; (2) the pcas were not substantially related to or supportive of said inpatient facility. [cite?] such a finding would appear to stop the analysis and render applying the predominant use test unnecessary. the following year after methodist hospitals, the indiana tax revenue board faced a property tax exemption issue in st. margaret mercy healthcare centers, inc. v. lake county property tax assessment board of appeals.82 this case involved st. margaret mercy (“mercy”), owned by the sisters of st. francis health services, inc., which operated two acute care hospitals in hammond, indiana, (the “north campus”) and dyer, indiana (the “south campus”).83 mercy argued that three physicians’ offices (the “practices”)–located in munster (the “munster office”), whiting (the “sibley clinic”), and hammond (the “woodmar clinic”), respectively and owned by mercy, were entitled to a charitable purposes exemption because the practices were substantially related to and supportive of mercy’s inpatient facility.84 responding to the balanced budget act of 1997, coupled with an increasingly competitive market and a move toward risk reimbursement systems, mercy “developed a strategic plan to establish an integrated healthcare delivery system with primary care and specialty physicians.”85 the focus of the strategic plan was to “form a geographically broad network of employed and independent physicians so st. margaret mercy could provide access to care in as many communities as possible.”86 to effectuate this plan, mercy determined its market share needed to increase to 40 percent.87 to do so, mercy aimed to increase its “physician network to at least 40 employed primary care physicians and to create a management services organization (mso) that would be capable of providing business services to employed physicians and other physicians that would be affiliated with the hospital.”88 for the physicians employed by the hospital and for the physician practices that were acquired, a requirement of seeing all patients, regardless of ability to pay, was placed in the employment contracts, in addition to the requirement that physicians refer all patients needing inpatient facilities to mercy’s hospitals, subject to patient and payer preference.89 81. id. 82. st. margaret mercy healthcare ctr. v. lake cnty. prop. tax assessment bd. app., pet. 45-023-00-2-8-00010 (ind. tax rev. bd., july 8, 2008). 83. id. at 9. 84. id. at 7-9. 85. id. at 10. 86. id. 87. id. at 9. 88. id. 89. id. 2023] taxation and telehealth 397 mercy argued that the three physician practices were entitled to a charitable purposes exemption because they provide family practice medical services and internal medicine services to patients, generating “significant revenues at the hospital[s].”90 in response, the lake county tax assessment board argued that, under methodist hospitals, merely referring patients to mercy hospitals is insufficient to show that the physician practices were associated, to a considerable degree, with the hospital’s inpatient facility because the practices were acquired with the intention of increasing the inpatient and outpatient income for the hospital, and therefore were aimed at making a pecuniary profit.91 furthermore, lake county argued that methodist hospitals require the physician practices to be “substantially used to provide medical care to” mercy’s inpatients, and the practices here “only provided an avenue for patients to receive and pay for services at st. margaret [mercy] instead of a competition facility.”92 moreover, even if this was enough to demonstrates a sufficient relationship of support or relation to mercy’s hospitals, “no specific evidence of the number of referrals from any [physician practice]” to st. margaret mercy hospitals was provided.93 the board began its analysis by declining to interpret methodist hospitals to “require that the physician practices only treat patients seen in st. margaret mercy’s inpatient facilities, or that st. margaret mercy’s physician practices must predominantly treat patients that are seen in its inpatient facilities for such facilities to be exempt.”94 however, mercy “must show more than that its physician practices are employed by the hospital and are required to admit patients to the hospital” to be entitled to an exemption.95 the board determined that mercy presented sufficient evidence to show that the physician practices sufficiently relate to its inpatient facilities, concluding that the evidence: established that the physician practices generated significant referrals to its inpatient facilities in 2000. moreover, the physician practices contributed substantial revenue that supported the inpatient facilities. in fact, the evidence suggests that without the patient referrals and financial contribution of the physician’s practices, st. margaret mercy’s inpatient facilities may not have remained financially viable and may not have continued to exist. similarly, the petitioner’s evidence showed that the physician’s practices lost money on their own. therefore, the primary purpose of those practices, if not the only purpose, must be to support the hospitals.96 90. id. at 14. 91. id. at 15. 92. id. at 16. 93. id. 94. id. at 22. 95. id. 96. id. at 23. 398 indiana health law review [vol. 20:385 it would appear then that mercy’s reliance on inpatient referrals from the physician practices to remain financially viable was a key factor leading the board to find that the practices were sufficiently related to the hospital’s inpatient facilities. the indiana tax board’s most recent decision on extending the charitable purposes exemption to other property owned by an exempt hospital was in the 2019 st. mary’s building corp. v. warrick county assessor case.97 here, st. mary’s building corporation – a 501(c)(2) nonprofit corporation and subsidiary of st. mary’s health, inc., (the “hospital”) – owned epworth commons, a medical building located off the hospital’s main campus.98 the building corporation sought a charitable purposes exemption for 82 percent of epworth commons, the proportion of the facility which was leased to st. mary’s breast cancer, llc, st. mary’s medical group, llc., and the hospital.99 the board, relying on the court’s decision in methodist hospitals, concluded that the operations of epworth commons were not substantially related to or supportive of st. mary’s health because: (1) the administrative control of epworth commons by st. mary’s health was insufficient to show the facility supported st. mary’s health’s inpatient facility, (2) epworth commons’ involvement in st. mary’s health’s overall mission was also insufficient to show support, and (3) epworth commons providing services more for the general public than st. mary’s health inpatients evidenced a separation from supporting the hospitals inpatient facilities.100 importantly, the board found that st. mary’s health billed the medical services performed at epworth crossing as “hospital outpatient services.”101 as such, the board determined that “[i]t does not logically follow that outpatient services are evidence of an inpatient use of a building,” and that st. mary’s health merely operated epworth crossing as an outpatient facility as part of the hospital’s overall mission.102 this did little to show how “the operations at epworth crossing relate to the hospital’s inpatient facility.”103 the board likewise declined to follow petitioner’s reliance on indianapolis osteopathic hospital inc v. department of local government finance.104 the board drew “important distinctions” between indianapolis osteopathic and the facts before it, namely that the medical pavilion was located on the respective hospital’s main campus while epworth commons was not.105 however, it should be noted that the proximity or location of the facility in indianapolis osteopathic 97. st. mary’s v. warrick cnty. assessor, pet. 87-019-15-2-8-01458-16 (ind. tax rev. bd., feb. 23, 2018) (aff’d st. mary’s bldg. corp. v. redman, 135 n.e.3d 681) (ind. t.c. 2019)). 98. id. 99. id. 100. id. 101. id. 102. id. 103. id. 104. id. 105. id. 2023] taxation and telehealth 399 hosp. inc was not a factor in the court’s decision to find a charitable exemption extended to the portion of the mp used by westview hospital departments.106 moreover, one of the pcas in methodist hospitals was located on methodist’s southlake campus.107 furthermore, the board found that the facts of indianapolis osteopathic demonstrated “a level of integration between the hospital departments at the medical pavilion and the inpatient facility of westview hospital,” whereas the facts before it could not demonstrate such a relationship between epworth crossing and the inpatient facility of st. mary’s health.108 c. applying the case law to the hypothetical telehealth facility the telehealth facility, for purposes of the forthcoming application, would be set up and function as follows: (1) be owned by an exempt hospital, (2) be located in the cass county service area, (3) serve individuals in that area regardless of ability to pay, (4) offer any service which could adequately be performed through telehealth, and (5) such services would be provided by the exempt hospital’s employees, who would be located at the exempt hospital main campus. applying these parameters to the above case law, the telehealth facility must first show evidence that it is associated considerably with the main hospital’s inpatient facilities or that it provides considerable aid to or supports the main hospital inpatient facilities. evidence of such a relationship appears to include physicians who provide services to the hospital’s inpatients and provide services at the telehealth facility.109 however, it is the facility itself, not the physicians, which must be substantially used to provide medical care to the hospital’s inpatients.110 therefore, although physicians that virtually see patients at the telehealth facility will in most cases also see patients who are inpatients of the hospital, this will likely be insufficient to show that the telehealth facility is being used to provide substantial care to the inpatients of the hospital. evidence of high referrals to the hospital’s inpatient facility from services rendered at the telehealth facility may establish a sufficient connection to show a substantial relationship, but it is unclear if this alone would be enough. while such evidence was present in st. margaret mercy healthcare centers, the 106. indianapolis osteopathic hosp., inc v. dep’t of local gov’t fin., 818 n.e.2d 1009, 101819 (ind. t.c. 2004). 107. methodist hosps., inc. v. lake cty. prop. tax assessment bd. app., 862 n.e.2d 335, 336 (ind. t.c. 2007). 108. st. mary’s v. warrick cnty. assessor, pet. 87-019-15-2-8-01458-15, at 30 (ind. tax rev. bd., feb. 23, 2018) (aff’d st. mary’s bldg. corp. v. redman, 135 n.e.3d 681 (ind. t.c. 2019)). 109. see methodist hosp.’s., inc. v. lake cnty. prop. tax assessment bd. app., 862 n.e.2d 335, 340 (ind. t.c. 2007) (“to the extent that pca physicians have provided medical care to methodist’s inpatients, methodist has shown that some relationship or degree of support exists between the pcas and methodist’s inpatient facilities.”). 110. id. (substantial service provided to the general public does not show “that the pcas were substantially related to or supportive of methodist’s inpatient facilities (i.e., substantially used to provide medical care to methodist’s inpatients).”). 400 indiana health law review [vol. 20:385 evidence also showed that the hospital relied heavily on these referrals to remain financially viable.111 the purpose of acquiring those physician practices was not solely based on the goal of increasing access to care, but to increase the inpatient services offered by the hospital. this differs greatly from the facts in st. mary’s building corp., in which the hospital conceded that it would remain viable without the services provided at epworth crossing, and the hospital’s cfo testified that “the purpose of the epworth crossing facility was generally to provide additional access for people to reach st. mary’s health services.”112 a consistent theme in each case outlined above is the principal that mere ownership and administrative involvement by an exempt hospital in the operations of a facility classified as other property–including employing the physicians and staff that run the facility–is insufficient to show a substantial relationship to the inpatient facilities of the hospital. secondarily, claiming that the hospital and the facility are sufficiently related through the facility being operated to further the hospital’s overall mission is, alone, insufficient. specific evidence of how the facility’s operations relate, aid, support, or promote the inpatient facility of the hospital is needed to satisfy the requirement under section 16(h). however, what evidence is needed is not entirely clear. it largely depends on what services are being provided at the telehealth facility and if those same services are also provided to the inpatients of the hospital. thirdly, whether the facility is referring a high volume of individuals to the hospital’s inpatient facility and whether the hospital is relying on those referrals to remain financially viable also appear to be of great importance. therefore, while limited to the scope contemplated by this note, it is at best unclear whether the exempt hospital would be able to demonstrate, with sufficient evidence, that the telehealth facility is substantially related to or supportive of its inpatient facilities. d. statutory exceptions under indiana code § 6-1.1-10-16(h) indiana code section 6-1.1-10-16(h) provides two exceptions for other property which is not “substantially related to or supportive of” the exempted hospitals inpatient facility.113 under subsection (h)(1), an exemption may be granted if the additional property is found to support the provision of charity care, as defined by indiana code section 16-18-2-52.5.114 this exception requires “the unreimbursed cost to a hospital of providing, funding, or otherwise financially supporting health care services” be provided to: “(1) a person classified by the hospital as financially indigent or medically indigent on an inpatient or outpatient 111. st. margaret mercy healthcare ctr., inc. v. lake cnty. prop. tax assessment bd. app., pet. 45-023-00-2-8-00010, at 16 (ind. tax rev. bd., july 8, 2008). 112. st. mary’s v. warrick cnty. assessor, pet. 87-019-15-2-8-01458-15, at 12 n.11 (ind. tax rev. bd., feb. 23, 2018) (aff’d st. mary’s bldg. corp. v. redman, 135 n.e.3d 681 (ind. t.c. 2019)). 113. ind. code § 6-1.1-10-16(h) (2018). 114. see ind. code § 6-1.1-10-16(h)(1) (2018). 2023] taxation and telehealth 401 basis,” and “(2) financially indigent patients through other nonprofit or public outpatient clinics, hospitals, or health care organizations.”115 moreover, indiana code section 6-1.1-10-16(h)(2) provides an exemption for additional property found to provide a community benefit as defined by indiana code section 16-219-1.116 a community benefit means “the unreimbursed cost to a hospital of providing charity care, government-sponsored indigent health care, donations, education, government-sponsored program services, research, and subsidized health services.”117 looking again to st. margaret mercy healthcare centers, mercy also argued that the physician practices were entitled to an exemption by providing charity care and community benefits.118 to support its argument, mercy offered its charity care policy, which required the physician practices to provide care at a reduced cost or at no cost to qualifying patients. the employment contracts also required that the physicians “see any and all patients who present without regard to their financial ability to pay,” and “doctors risked termination if they fail[ed] to provide patient services” without regarding the individual’s ability to pay.119 in turn, this policy resulted in the physician practices providing “more care to medicaid patients than the national average and [the] employed physicians did not see as many privately insured patients as their peers.”120 mercy also provided a consolidated summary of social accountability expenditures, which quantified the benefits provided to the poor and the community by the hospital.121 however, information regarding the community benefits attributable to the physician practices was not provided.122 the board first found that while the two exceptions to indiana code section 6-1.1-10-16(h) “do [] not specify a minimum amount of charity care and community benefit necessary to qualify for exemption…there must be some meaningful contribution” shown for the purpose of affording tax-exemption status is to be properly served.123 as applied to the evidence presented by mercy and contained in the record, the board was able to find that the hospital presented sufficient evidence showing the physician practices supported its provision of charity care because “the physicians must accept any patient, ‘[d]irect evidence was presented which quantified the financial contribution the offices make to support [the hospital’s] provision of charity care,’” and the physician practices served “previously un-met or underserved needs in the community.”124 115. see ind. code § 16-18-2-52.5(a) (1994). 116. ind. code § 6-1.1-10-16(h)(2) (1975). 117. ind. code § 16-12-9-1 (1994). 118. st. margaret mercy healthcare ctrs., inc. v. lake cnty. prop. tax assessment bd. app., pet. 45-023-00-2-8-00010, at 22 (ind. tax rev. bd., july 8, 2008). 119. id. 120. id. 121. id. at 23. 122. id. at 22. 123. id. at 23. 124. id. at 25 (testimony demonstrated that st. margaret mercy “identified its market area and 402 indiana health law review [vol. 20:385 the board in st. mary’s building corp., however, found differently. following its conclusion that epworth crossing could not establish exemption based on the substantially supportive standard under indiana code section 6-1.110-16(h), the board turned to whether epworth crossing could claim exemption through the exceptions under subsections (h)(1) & (2). the board first had to articulate the scope of the predominate use test under indiana code section 6-1.110-36.3. the assessor argued that because the exceptions above are based on the hospital’s expenditures on charity care as measured by unreimbursed costs, the test requires that the expenditures on charity care be predominately through unreimbursed costs.125 however, the board found this view to be incorrect and stated that the test requires the board to “determine if the property was used most of the time to deliver charity care and community benefits,” as the focus is the time spent delivering charity care and not the amount of charity care.126 the evidence before the board indicated that epworth crossing provided medical services which were sometimes reimbursed and sometimes not. but no evidence showing the amount of time the facility provided unreimbursed services versus the amount of time the facility provided reimbursed services was offered, and the board could not allow for an exemption.127 as such, the board (and the tax court on appeal), concluded that at most, epworth crossing was shown to provide some form or amount of charitable health services; this conclusion did not determine what amount of those services were charity care, how those services constituted charity care, or how much time the facility was used to provide such care. e. statutory application to the telehealth facility the facility’s location in a rural and medically underserved area appears to be beneficial evidence for establishing charity care and community benefit. while the epworth crossing facility provided services to everyone regardless of their ability to pay, its location in warrick county, at least, implicitly suggested that its ability to provide charity care was limited to some extent.128 however, the physician practices in st. margaret mercy were specifically placed in areas of underservice and that lacked access to primary care--a fact the board determined relevant when concluding which practices were entitled to a charitable purpose exemption.129 put physicians in locations that needed primary care” and placed physicians in medically underserved areas.). 125. st. mary’s v. warrick cnty. assessor, pet. 87-019-15-2-8-01458-16 (ind. tax rev. bd., feb. 23, 2018) (aff’d st, mary’s bldg. corp. v. redman, 135 n.e.3d 681 (ind. t.c. 2019)). 126. id. 127. id. 128. id. (noting warrick county has a population with 11.8 percent uninsured and 7.5 percent in poverty). 129. st. margaret mercy healthcare ctrs., inc. v. lake cnty. prop. tax assessment bd. app., pet. 45-023-00-2-8-00010, at 25 (ind. tax rev. bd., july 8, 2008). 2023] taxation and telehealth 403 furthermore, the telehealth facility must ensure that it presents evidence demonstrating it was predominately used for providing charity care and community benefits at unreimbursed costs. sufficient evidence was a key factor leading to the board’s denial of a charitable purposes exemption for epworth crossing. however, some practitioners have argued that the tax court’s interpretation of the predominate use test in redman may result in indiana assessors denying property tax exemptions because of the test’s heightened standard.130 v. the argument a. broadening exemption status to include all property owned and operated by nonprofit hospitals as it stands, other property owned by an exempt hospital in indiana faces an uphill battle to qualify for a charitable purposes exemption. to an extent, it is logical to place parameters on how far a nonprofit hospital can take exemption status. however, having three different standards that appear to overlap with each other (e.g., the predominate use test) may lead to inconsistent rulings and have a negative impact on innovative approaches to health by nonprofit hospitals. of extreme importance–as far as this note is concerned–is the fact that nearly all the opinions on this issue have analyzed a facility or facilities that were located either on or relatively close to the main hospital’s campus. but with modern medical approaches to health beginning to embrace the possibilities of telehealth, indiana could find itself behind the curve because of unresolved issues regarding where the exemption requesting facility is in relation to the main hospital facility.131 a second area of concern is also advanced by the potential negative effects to competition in the telehealth facility market, both between nonprofit hospitals and private-for profit telehealth groups, and between states. in the first instance, because state and local property tax exemptions are of extreme importance to nonprofit hospitals in furthering their charitable missions, nonprofit hospitals would have a barrier to entering the telehealth facility market because of the additional requirements placed on them to demonstrate that their additionally owned property is eligible for property tax exemption. stated differently, the additional statutory requirements for additionally owned property would likely dissuade nonprofit hospitals from entering this market, which would lessen market participation to include private telehealth companies and for-profit hospitals. as for-profit entities, these participants likely would not find much financial sense in locating their facilities in rural, medically underserved areas, 130. hall render, supra note 39. 131. see st. mary’s med. ctr., inc. v. state bd. of tax comm’rs, 534 n.e.2d 277, 279 (ind. t.c. 1989) aff’d sub nom., st. mary’s med. ctr. v. state bd. of tax comm’rs, 571 n.e.2d 1247, 1248 (ind. 1991) (“move the office building down the road two miles and a serious question arises, even under the most liberal statutory construction, as to whether it would then significantly further, or be incidental to the operation of appellant’s hospital.”). 404 indiana health law review [vol. 20:385 which would only enhance the current problems with access to care for hoosiers living in those areas. moreover, nonprofit hospital systems outside of indiana would likely not find indiana as an attractive option for entering this market and instead would favor entry in states which have less restrictive laws regarding property tax exemption on the books. therefore, to avoid further confusion and likely litigation regarding the telehealth facility and to potentially increase both nonprofit hospital and indiana participation in this market, indiana may benefit by expanding the code provisions relating to property tax exemption for nonprofit hospitals to include all property which is owned by the exempt hospital and operated in furtherance of the exempt hospital’s mission of providing charitable care and meeting the community benefit standard required to maintain its 501(c)(3) status as a charitable organization. such code provisions are common in other jurisdictions and do not appear to be specific to any region of the country. b. illinois illinois’ approach to property tax exemption is addressed first by section six of article ix to the illinois constitution, which grants the illinois general assembly permissive authority to “exempt from taxation only the property of the state, units of local government and school districts and property used exclusively for agricultural and horticultural societies, and for school, religious, cemetery and charitable purposes.”132 while this constitutional provision does not grant the illinois legislature the power to “add to or broaden the exemptions specified in section 6,” it may “place restrictions, limitations, and conditions on [property tax] exemptions as may be proper by general law.”133 this is exemplified under section 15-65 of the illinois code, which requires the subject property “not [be] leased or otherwise used with a view to profit.”134 therefore, eligibility for a charitable exemption under illinois law requires both, charitable ownership and charitable use.135 property is exclusively used for charitable purposes when charitable purposes are the primary ones for which the property is utilized. secondary or incidental charitable benefits will not suffice, nor will it be enough that the institution professes a charitable purpose or aspires to using its property to confer charity on others.136 as a result, the illinois supreme court in provena covenant medical center upheld the denial of the hospital’s property tax exemption because it was unable to demonstrate that it was used exclusively for charitable purposes.137 in response to the “considerable uncertainty surrounding the test for charitable property tax exemption, especially regarding the application of a 132. ill. const. art. ix, § 6. 133. provena covenant med. ctr. v. dep’t of revenue, 925 n.e.2d 1131, 1144 (ill. 2010). 134. 35 ill. comp. stat. 200/15-65 (2009). 135. provena covenant, 925 n.e.2d at 1147. 136. id. 137. id. at 1154. 2023] taxation and telehealth 405 quantitative or monetary threshold” following provena covenant medical center, the illinois legislature adopted a formulaic standard for determining charitable exemptions for property.138 the standard provides that “if the value of services or activities listed in subsection (e) for the hospital year equals or exceeds the relevant hospital entity’s estimated property tax liability,” then it “shall be issued a charitable exemption for that property.”139 the factors considered in this calculation under subsection (e) are quite broad, including: “[f]ree or discounted services measured at cost”; health services to lowincome and underinsured individuals; subsidy of state or local governments; support for state health care programs for low-income individuals; subsidy for treating dual-eligibility medicare/medicaid patients; relief of the burden of government-related health care of lowincome individuals; and “[a]ny other activity by the relevant hospital entity that the department determines relieves the burden of government or addresses the health of low-income or underserved individuals.”140 however, exclusive use for charitable purposes remains the ultimate factor in determining whether a hospital is entitled to an exemption, and evidence showing that a facility which uses “some of its revenue for providing gratuitous services” but “ordinarily expects to be fully compensated for its services” is insufficient to demonstrate it is entitled to an exemption.141 this standard would benefit the telehealth facility primarily because of its location. because the statute allows for tax authorities to consider additional criteria that it determines to “address[] the health of low-income or underserved individuals,” the telehealth facility is likely to satisfy this standard by virtue of being in and providing services to a medically underserved area.142 moreover, while requiring that the facility seeking an exemption be owned by a charitable institution, emphasis is placed on how the facility is used and whether that use is exclusively charitable. this standard, therefore, does not contemplate a separate test for a facility that is owned by a nonprofit hospital versus a facility owned by a nonprofit group, and instead requires only that the facility have charitable ownership and be used exclusively for charitable purposes. this standard would bring clarity for facilities which are owned by a nonprofit hospital because the requirement that a facility be substantial related to or supportive of the main hospital’s inpatient facility would be replaced by the requirement that the facility be used exclusively for charitable purposes, the costs of which either equals or exceeds the facility’s estimated amount of property tax liability. 138. see 35 ill. comp. stat. 200/15-86 (2012). 139. id. 140. oswald v. hamer, 115 n.e.3d 181, 190 (ill. 2018) (citing 35 ilcs 200/15-86(e)(1)-(7) (2015)). 141. see midwest palliative hospice & care ctr. v. beard, 125 n.e.3d 1196, 1204 (ill. ct. app. 2019). 142. 35 ilcs 200/15-86, supra note 138. 406 indiana health law review [vol. 20:385 c. ohio ohio does not extend any specific exemptions to nonprofit hospitals, rather provides exemptions to property used for charitable purposes.143 while not specifically referenced by statute, section 5709.12(b) provides that “[r]eal and tangible personal property belonging to institutions that is used exclusively for charitable purposes shall be exempt from taxation.”144 the ohio supreme court has recognized that “the provision of medical or ancillary healthcare services qualifies as charitable if those services are provided on a nonprofit basis to those in need, without regard to race, creed, or ability to pay.”145 therefore, where the core activity of a hospital or facility is providing healthcare services, it would qualify as a charitable institution “only if it provided services on a nonprofit basis to those in need, without regard to race, creed, or ability to pay.”146 moreover, the owner of the property seeking exemption qualifies as a charitable entity under section 501(c)(3) of the internal revenue code is not solely determinative of whether the property is entitled to an exemption.147 ultimately, the crucial factor in determining whether property is used for charitable purposes hinges upon whether the property provides services to the general public regardless of race, creed, ability to pay, “or [is open] to serve that part of the general public that has a special need.”148 because this standard focuses on the use of the facility seeking exemption, the hypothetical telehealth facility will likely find it easier to qualify for property tax exemption because it would be in a medically underserved area and would provide medical services to individuals who lacked adequate access to those services. moreover, while a property owner cannot qualify for exemption based solely on its owner’s status as a section 501(c)(3) entity, it is possible the hypothetical telehealth facility could rely on the owning nonprofit hospital’s exemption status under ohio law to be extended, provided, the facility is used “in furtherance of the owner’s charitable purposes.”149 as a result, the hypothetical facility would not be required to demonstrate that the services it provides substantially relate to or support those at the main hospital’s inpatient facility, which likely would lead to innovative methods for delivering healthcare services to at-risk populations and medically underserved areas. d. arkansas the arkansas court of appeals in hardesty v. northern arkansas medical services, extended property tax exemptions to additionally owned property operated as an outpatient facility. under hardesty, property tax exemption is 143. see ohio rev. code § 5709.12 (2017). 144. ohio rev. code § 5709.12(b) (2017). 145. church of god in n. ohio, inc. v. levin, 918 n.e.2d 981, 985 (ohio 2009). 146. dialysis clinic, inc. v. levin, 938 n.e.2d 329, 336 (ohio 2010). 147. id. 148. dialysis ctrs. of dayton, llc v. testa, 80 n.e.3d 477, 482 (ohio 2017). 149. ohio rev. code § 5709.121(a)(2) (2021). 2023] taxation and telehealth 407 extended to additional property, on which the main hospital operates an outpatient facility, so long as the facility: “(1) is open to the general public, (2) no one may be refused services on account of inability to pay, and (3) all profits from paying patients are applied to maintaining the hospital and extending and enlarging its charity.”150 in that case, the court agreed with the hospital’s argument that “generating income does not destroy the charitable usage of the hospital or its clinics” as long as the income generated is “used solely to further its charitable purposes.”151 moreover, “a particular percentage of free medical care” is not required to be shown.152 implementing this standard allows other property owned by a nonprofit hospital to qualify for property tax exemption, even if it received reimbursement or payment for its services, so long as it used those funds to cover services for individuals unable to pay. this would ease the hospital’s burden of proving that the facility’s predominant use was for unreimbursed services and would likely ease the record keeping requirements for the facility. thus, provided the hospital is able to prove that any income generated from reimbursement or payment was used to cover visits for individuals who could not pay, it would be entitled to exemption from property tax. furthermore, like indiana, arkansas also maintains that “the property’s use determines entitlement to a tax exemption rather than the use of its revenues.”153 this reflects the basic principle of the predominant use test yet stops short of mandating the property be used to provide charity care for over 50 percent of the time to claim an exemption. instead, the property “must be a place open to the public where no one may be refused services on account of inability to pay and where all profits from paying patients are applied to maintaining the hospital and extending and enlarging its charity.”154 e. oklahoma in oklahoma, property tax exemption is provided for directly by statute. 68 oklahoma statute section 2887 lists the types of property that are exempt from ad valorem taxation.155 subsection (10) is directed to nonprofit hospitals, and exempts from property taxation: “[a]ll property of any hospital established…as a nonprofit and charitable hospital, provided the property and net income from such hospital are used directly, solely, and exclusively within this state for charitable purposes and that no part of such income shall inure to the benefit of any individual, person, partner, shareholder, or stockholder, and provided 150. hardesty v. n. ark. med. serv.’s, 585 s.w.3d 177, 3 (ark. ct. app. 2019) (quoting burgess v. four states mem’l. hosp., 465 s.w.2d 693, 679 (ark. 1971)). 151. hardesty, 585 s.w.3d at 4. 152. id. at 7. 153. id. at 8. 154. id. (internal citation omitted). 155. see 68 okla. stat. § 2887 (2021). 408 indiana health law review [vol. 20:385 further that such hospital facilities shall be open to the public without discrimination as to race, color or creed and regardless of ability to pay, and that such hospital is licensed and otherwise complies with the laws of this state relating to the licensing and regulation of hospitals[.]”156 simply put, if additional property is owned by a nonprofit hospital and used in a manner which provides charity care–even if some of the services provided are either reimbursed or paid for out of pocket by patients–the property is entitled to exemption from property taxation so long as any profit made is used to further provide for charity care. this language is clear, unambiguous, and generally unfettered by difficult statutory tests to determine the percentage of time a property is used for charity care purposes. f. addressing concerns to competition: a model code solution as referenced above, competition in this hypothetical market may revolve around determining which states have more relaxed statues governing property tax exemptions. where exemption under section 501(c)(3) is governed by a set standard of community benefit, property tax exemption at the state level centers around charity care, the definition of which varies from state to state.157 not only does each state have differing definitions of what constitute charity care, the test used by courts in determining property tax exemption cases vary from being qualitative in nature, based on sets of factors, or a hybrid of both.158 moreover, many states do not have specific exemption standards for nonprofit hospital property, but rather provide blanket exemption standards for charity or charitable institutions.159 this approach has been argued to not recognize the difference between nonprofit hospitals and standard charities, including the type of benefits offered to the community, the difference in funding sources, and effect of profits between nonprofit hospitals and standard charities.160 the differing, and often confusing, standards used to determine what is precisely meant by charity care has a negative impact on nonprofit hospital systems across the country.161 this, along with the importance of property tax exemptions as capital for the operations of nonprofit hospitals, arguably results in nonprofit hospital systems choosing to build and operate facilities in states with unambiguous and clear defined standards, which in turn, presents a disadvantage to medically underserved populations in states whose laws lack such clarity. this potential imbalance could be adequately addressed by adopting a uniform standard of charity care, which would bring clarity and consistent rulings across 156. see 68 okla. stat. § 2887(10) (1983). 157. see lowell r. mintz, the rules of the fight must be fair: states should pass a uniform code for nonprofit hospital tax exemption of real property, 26 j. l. & health 415, 423 (2013). 158. id. 159. id. 160. id. at 435. 161. id. 2023] taxation and telehealth 409 the country and benefit medically underserved areas in states like indiana.162 vi. conclusion as approaches to delivering health care and increasing access to care for individuals through telehealth increases in both popularity and demand, nonprofit hospitals in indiana will likely find themselves at a disadvantage should they desire to open a satellite telehealth facility because of the uncertainty surrounding the state and local property taxation exemption status of said facility. as applied to the current indiana statutes regarding property tax exemption for other property owned by an exempt hospital, it is unclear whether such a facility would meet any of the required statutory tests to be entitled to an exemption, and it is also unclear which statutory tests apply. this general confusion, coupled with the unresolved issue regarding the location of the exempt hospital facility and the satellite facility, will lead to unnecessary litigation and further confusion in attempting to determine whether the telehealth facility would be entitled to a charitable purposes exemption. rather than avoiding the unanswered issues and increasing likelihood of future litigation, it is prudent for the indiana legislature to act by amending the current property tax exemption statutes to allow for all property owned by an exempt hospital to be entitled to a charitable purposes exemption. of course, said property must be owned by an exempt hospital and be operated in furtherance of the exempt hospital’s mission of providing charitable care and meeting the community benefit standard required to maintain the main hospitals 501(c)(3) status as a charitable organization. such action will address the current need for increasing access to care in designated medically underserved areas, especially areas in rural counties with disparate access to broadband services. additionally, providing a clear pathway for other owned property to receive a charitable purposes exemption for property taxes allows nonprofit hospitals to further their charitable mission by meeting the needs of care in an increasingly digital age of health care. furthermore, placing an emphasis on how reimbursed costs and profits are being redistributed into the facility to further its provision of charity care to those patients who cannot pay allows the facility to focus on its mission of providing services to those who need it, rather than having to spend time ensuring that they are providing charity care more than 50 percent or more of the time or what amount of unreimbursed costs they currently operate with. finally, allowing all property owned by an exempt hospital to be covered–if providing charity care is demonstrated–takes the emphasis off relating substantially to the inpatient facility of the exempt hospital, which is a confusing and difficult standard to apply to a telehealth facility, and other similarly situated outpatient centric facilities. 162. id. at 448. under-treatment of pain in black patients: a historical overview, case-based analysis, and legalities as explored through the tenets of critical race theory muhammad hamza habib* abstract pain, also called the “fifth vital sign” is an important topic in healthcare settings. it requires urgent attention and treatment to minimize agony and discomfort. unfortunately, multiple clinical studies conducted over the last few decades have repeatedly shown disparately inferior pain management in black patients in medical settings when compared to white patients with similar pain levels. this article utilizes critical race theory to examine the understudied issue of under-treatment of pain in black patients. it discusses the story of a real patient, jacqui, who was under the medical care of the author. it examines her unfortunate experiences with poor pain management throughout different stages of her life, including a blood disorder as a child with, a traumatic arm fracture as a teen, during childbirth, and finally, later in life with advanced cancer. three points are addressed in this article: first, a discussion of jacqui’s experiences, and an analysis of those experiences through the available clinical data. this article reveals the extent to which black patient’s pain is undertreated, and how it led black patients to mistrust our healthcare system. second, the article explores malpractice based legal analyses to these issues based on federal and state legislation. third, various proposals to correct various systemic discrepancies in medical-education and clinical settings to minimize such racial biases in pain management are discussed. it concludes by talking about the final part of jacqui’s clinical journey. introduction jacqulyn dillon, who preferred to go by jacqui, was a 46-year-old patient with a history of sickle cell disease with multiple painful crises during her childhood. about three years ago (at the age of 43), jacqui was diagnosed with breast cancer, that had spread into her liver and bones, including her spine and ribs. jacqui had previously received chemotherapy and radiation to treat her cancer, but unfortunately, the disease continued to spread. during our first meeting, jacqui’s provided details regarding her clinical case, who was on a phase-1 clinical trial after her cancer further grew on the last line of chemotherapy. a clinical trial under her circumstances, is a treatment regimen whose safety and efficacy has not been completely proven. clinical trials are administered as a last resort to treat the patient’s untreatable cancer, but its primary intent is to * assistant professor of medicine; director, outpatient palliative medicine and cancer pain service; interventional pain medicine/ hospice & palliative medicine; rutgers cancer institute of new jersey, division of medical oncology. 64 indiana health law review [vol. 20:63 determine its safety and side effects in humans. also, clinical trials determine whether such treatments will stop the growth of a specific cancer. in short, clinical trials are an attempt to primarily see if future patients will benefit from that particular treatment. at the start of the trial, and if the trial was unsuccessful, jacqui’s likely clinical prognosis was six months. i have worked closely with jacqui over the last year, managing her pain and providing supportive oncological and palliative care, providing support as she gradually moved towards a terminal stage of her cancer, which led to her death a few months later. pain has been called the “fifth vital-sign” in clinical settings.1 over the last few years, clinical research has shown significant under-treatment of pain in black patients compared to white patients under similar clinical circumstances.2 this article examines various angles of pain undertreatment in black patients through the lens of tenets of critical race theory (“crt”). racism in pain management settings, whether conscious or unconscious, is a permanent part of medical care for black patients, which involves all imaginable primary and specialty healthcare settings in the united states. it is later discussed how black patients are disadvantaged from a medication supply and pharmaceutical availability standpoint in their neighborhoods. it investigates deeper into the underlying causes of such disparity, looking at how news and entertainment media feed into a false narrative. it also discusses how the medical education system has failed to correct many long-standing fallacies relating to pain management in black patients. this article also explores the understudied issue of undertreatment of pain in black patients through a case study of a real-life patient, jacqui, and her encounters with disparities in pain management as a black patient. part i provides key medical definitions and understandings regarding pain. part ii introduces the tenets of crt, which this paper which will be used to discuss the undertreatment of black patients. part iii introduces jacqui and narrates her various health conditions, and her experience receiving care for pain associated with her medical issues. part iv contextualizes jacqui’s experience by providing a historical and medical research-based overview of poor medical care in black patients, which analyses the disparity, its social impact, and its role in subsequent mistrust of the healthcare system by the black community. part v examines the legalities and issues with malpractice in similar clinical scenarios by looking at legislation and case law. part vi focuses on approaches to minimize this discrepancy on various levels of clinical education, training, and healthcare management from an administrative and procedural standpoint. 1. natalia e. morone & debra k. weiner, pain as the fifth vital sign: exposing the vital need for pain education, 35 clinical therapeutics 1728, 1728-32 (2013). 2. shoshana v. aronowitz et al., mixed studies review of factors influencing receipt of pain treatment by injured black patients, 76 j. advanced nursing 34, 34-46 (2019). 2023] under-treatment of pain in black patients 65 i. understanding the medical term “pain” before venturing into a deeper analysis of the disparity of pain care among black patients, it is important to understand how pain is defined as a medical term in healthcare settings. this will help gather a better grasp of the issue from a technical aspect moving forward. a. the definition of pain and the subjectivity of its interpretation international association for the study of pain (“iasp”) defines pain as “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage”.3 pain is a sensory perception often in combination with an emotional component. this is the same emotional component that makes us scream, cry, and experience apprehension and distress when pain becomes overwhelming. furthermore, this definition adds that this combination of emotions may resemble something that is associated with actual or potential tissue damage. this adds the necessary subjective range to prior definitions of pain, where objective physical damage, and signs of actual trauma or disease were required to make a patients pain legitimate, while a lack of damage, or merely an emotional experience, previously made the pain less concerning, not receiving urgent attention, or even deemed as illegitimate or a sign of malingering.4 this addition of subjective and emotional range correctly recognizes previously missed aspects of pain, and sheds light on the subjective and variable interpretation of pain by clinicians. this is the same interpretation that leads to the dilemma of undertreatment of pain based on subjective clinical interpretation. in certain cases, it may even be based on objective data, while seen from a prejudiced subjective angle, consciously, unconsciously, or via implied bias, giving rise to disparate impact as the meaning of the word bias implies, it skews a clinician’s judgement.5 if viewed from a racial standpoint, such clinical bias distorts judgement in a direction that affects certain populations much more than the others from a therapeutic stance.6 in the case of clinical pain management, bias is skewed to significantly affect the black population more than white population, where data continues to show that undertreatment of black patients’ pain is actually a norm, and not an anomaly.7 3. iasp announces revised definition of pain, int’l ass’n for study pain (july 16, 2020), https://www.iasp-pain.org/publications/iasp-news/iasp-announces-revised-definition-of-pain/ [https://perma.cc/996f-c8zp]. 4. srinivasa n. raja et al., the revised international association for the study of pain definition of pain: concepts, challenges, and compromises, 161 pain 1976, 1979 (2020). 5. id. at 1980. 6. elizabeth n. chapman et al., physicians and implicit bias: how doctors may unwittingly perpetuate health care disparities, 28 j. gen. internal med. 1504, 1507 (2013). 7. kelly m. hoffman et al., racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites, 113 proc. nat’l acad. sci. 4296, 4301 (2016). 66 indiana health law review [vol. 20:63 b. options for pain management and its skewed use in clinical settings practitioners impliedly provide equal care, but unfortunately, bias results in separate and lower-end modality of treatment given under the umbrella of the word “care.”8 this is very reminiscent of plessy v. fergusson, where the constitutionality of “separate but equal” was upheld by a 7:2 supreme court ruling.9 for clinicians, there is data available to predict the efficacy of various treatments in certain painful conditions, ranging from its total benefit and the duration of the benefit, to the burden of these treatments and their side effects.10 this is the same data that is used when various oversight committees and expert panels make recommendations for first, second, and third line treatments for certain diseases and conditions.11 however, clinicians are often implicitly biased when interpreting these recommendations and in providing certain treatments to black patients versus white patients.12 to address this discrepancy, and to provide decisional defense, certain words, including “based on clinical circumstances,” or “individually tailored treatments,” are often documented. this usually implies that their prescribed treatments for black patients are different but equal when applied to an individual black patient. decades of clinical research data shows opioid medications as the “gold standard” for managing cancer pain.13 however, the outcomes are disturbingly different, with white patients having a greater likelihood of receiving opioids as early line treatments compared to black patients who get separate over-the-counter medications, non-opioid medications, or treatments with lesser pain management potential in cancers, often described as an equal treatment to their similar white counterparts.14 this leads to undertreatment of pain, which is often guised as equal, but circumstantially separate or individually tailored treatment. c. use of liberal terms to cover bias in pain management on various levels of healthcare system the term “individuality” refers to the difference in circumstances or 8. william j. hall et al., implicit racial/ethnic bias among health care professionals and its influence on health care outcomes, 105 am. j. pub. health 60, 71 (2015). 9. plessy v. ferguson, 163 u.s. 537, 552 (1896). 10. teus h. kappen et al., evaluating the impact of prediction models: lessons learned, challenges, and recommendations, 2 diagnostic & prognostic rsch. 11, 9 (2018). 11. richard m. rosenfeld & richard n. shiffman, clinical practice guideline development manual: a quality-driven approach for translating evidence into action, 140 otolaryngology head & neck surgery 1, 43 (2009). 12. hall, supra note 8, at 76. 13. phillip j. wiffen et al., opioids for cancer pain an overview of cochrane reviews, 7 cochrane database sys. rev. 1, 13 (2017). 14. dan p. ly, association of patient race and ethnicity with differences in opioid prescribing by primary care physicians for older adults with new low back pain, 2 jama 2333, 7-8 (2021). 2023] under-treatment of pain in black patients 67 difference in social or biological make up.15 the concept of colorblindness, which is often verbally over-stated in healthcare settings, is disfavored. more culturally appropriate terms like “individually tailored” are used to discriminate among patients based on their biological or social circumstances, and to preserve the concept of equal but separate, under the guise of these liberal and technically sound terminologies.16 this is further discussed in part ii, where such phenomenon is described under the crt tenet of “critique of liberalism,” where certain terms are used to cover for various discriminative practices. ii. tenets of critical race theory the term “tenet” stands for basic principles or doctrines.17 in relation to crt, these tenets describe the basic principles that most critical race theorists agree upon.18 this section discusses various tenets of critical race theory that are further explored and analyzed in this paper in relation to pain management in black patients: (1) the permanent nature of racism — racism, whether conscious or unconscious is a permanent part of life in the u.s.; (2) whiteness as property — the benefits of being white, and how the judicial and governing system in the us has advantaged the white majority, so much so that being white can be considered a property interest; (3) story telling counter to majoritarian views — a method of storytelling that tells the counter side of majoritarian views held as facts, interpreting majoritarian views as myths and false beliefs; (4) interest convergence a means for benefitting blacks are only sought when they also help with the interests and goals of the white majority; (5) criticism of liberalism — a criticism of closely held liberal beliefs of meritocracy, colorblindness, and legal neutrality; (6) intersectionality — the effect of the intersection of race and other defining characters like gender, age, and financial stability; and (7) essentialism — a view that people have a set of attributes that identify them, also implying that social hierarchies reflect a naturally occurring structure, with particular prejudice against black people.19 15. s. denford et al., individualisation of drug treatments for patients with long-term conditions, 4 bmjopen 3, 4 (2014). 16. marshall h. chin et al., interventions to reduce racial and ethnic disparities in healthcare, 64 med. care rsch. rev. 7, 6-10 (2007). 17. tenet, merriam-webster (11th ed. 2012). 18. richard delgado & jean stefancic, critical race theory: an introduction 8-11 (3rd ed. 2016). 19. adopted and modified from, sonya douglass horsford, mixed feelings about mixed schools: superintendents on the complex legacy of school desegregation, 46 educ. admin. q. 287, 287-321 (2010). 68 indiana health law review [vol. 20:63 iii. jacqui’s story story telling is an important part of critical race theory. here, we discuss this disparity of under-treatment of pain in more detail in the form of a clinical case of a black woman “jacqui”, who was under the care of this author for cancer pain management. this article will explore her experiences with disparity in pain treatment during different phases of her life. the names and other identifiers in this article have been changed to comply with hipaa privacy rules.20 a. jacqui’s experience as a black child jacqulyn dillon, who preferred to go by jacqui, was a forty-six-year-old patient with history of sickle cell disease since her childhood. jacqui was born in trenton, new jersey, in a predominantly black neighborhood. she was the middle child of three sisters. her father worked in a local factory, while her mother was a homemaker. jacqui grew up in a strong christian household where her parents took her and her sisters to their local church on sundays. when jacqui was eight years old, her father died of a sudden heart attack. her mother worked small jobs to cover the financial needs of the family. it was about the same time when she gradually started feeling very weak and fatigued. her mother took her to the local doctor, who after some blood tests diagnosed her with sickle cell disease. sickle cell disease is a hereditary blood disorder where the red blood cells, that carry oxygen in blood to various parts of the body, causing the red blood cells to become deformed and pointy in shape, which reduces their oxygencarrying capacity.21 also due to their pointy edges, these cells block various small blood vessels in the body, causing severe pain crises.22 additionally, over time, this disease deformity leads to multiple long-term liver, spleen and bone-related complications.23 sickle cell is more common in black americans, where about 1 in 13 black people asymptomatically carry the genes for this illness; but it fully expresses clinically in about 1 in 365 black people.24 sickle cell disease expresses fully in patients (often children) whose parents are both asymptomatic, silent carriers and pass these genes to their children, who get the disease-related gene from both parents, but inherit the symptomatic form of this illness.25 since this disease is common in black patients and causes repeated painful crises, opioid pain medications provide the best analgesia. however, opioid pain medication has developed a notoriously false reputation of causing the patients with this disease 20. 42 u.s.c. § 1320d (6). 21. what is sickle cell disease?, cdc (aug. 18, 2022), https://www.cdc.gov/ncbddd/ sicklecell/facts.html [https://perma.cc/kl8q-a9re]. 22. id. 23. see paula tanabe et al., understanding the complications of sickle cell disease, 119 am. j. nursing 26, 26-35 (2019). 24. data & statistics on sickle cell disease, cdc (may 2, 2022), https://www.cdc.gov/ ncbddd/sicklecell/data.html [https://perma.cc/8ap3-hzza]. 25. id. 2023] under-treatment of pain in black patients 69 to become dependent on such opioid pain medications.26 these patients are often clinically referred to as opioid-dependent or drug-seeking.27 going into the history of this disease, the research funding to finding an adequate cure for this black-predominant illness has been far less than that for more white-predominant diseases with similar morbidity rates.28 understanding how this disease got its stigma is also important here. only about 5% of physicians in the united states are black.29 thus, most sickle cell disease patients are treated by white doctors, who are not generally affected. this has led the disease to take an almost “alien disease” form, where the treaters are not aware of the horrors of pain and disability this disease can cause. when black patients complain of repeated painful episodes, this does not invoke the same level of compassion in the treating physicians, leading to general undertreatment of pain.30 in extreme cases, clinicians stigmatize the patients with feigning an illness, with the ulterior motive of receiving opioid painkillers.31 again, not having interest-convergence with white doctors makes the sufferers of this disease falsely portrayed as malingerers and drug-seekers for requesting adequate pain control.32 coming back to jacqui, during her first sickle cell crisis, she remembers being given a small dose of morphine (a moderate strength opioid) and being sent home. she was not given any strong pain medications to take home in the event of a pain crisis, which is a common occurrence for this illness. at the age of fourteen, jacqui had an episode of acutely worsening abdominal pain. she remembers doubling over in pain, and that is when her mother took her to a local emergency room, where the doctor diagnosed her with acute appendicitis. this disease has no documented association with sickle cell disease but based on her prior history of sickle cell disease, the emergency room physician decided not to give her adequate analgesia. jacqui was taken directly for surgery, where the inflamed appendix was removed. again, she was told to take over-the-counter 26. matthew zajac, sickle cell disease, myths and misconceptions, sickle-cell.com (dec. 6, 2020), https://sickle-cell.com/myths [https://perma.cc/ywy8-qttz]. 27. opioid crisis adds to pain of sickle cell patients, nat’l heart lung & blood inst. (sept. 15, 2017), https://www.nhlbi.nih.gov/news/2017/opioid-crisis-adds-pain-sickle-cell-patients [https://perma.cc/4ukv-8nwe]. 28. faheem farooq et al., comparison of us federal and foundation funding of research for sickle cell disease and cystic fibrosis and factors associated with research productivity, 3 jama 1737, 1743 (2020). 29. diversity in medicine: facts and figures 2019, ass’n am. med. c., https://www.aamc. org/data-reports/workforce/interactive-data/figure-18-percentage-all-active-physiciansrace/ethnicity-2018 [https://perma.cc/h94k-6tpg] (last visited oct. 20, 2021). 30. elise labbé et al., physicians’ attitude and practices in sickle cell disease pain management, 21 j. palliative care 246, 251 (2005). 31. jeremy park et al., physician use of stigmatizing language in patient medical records, 4 jama 17052, 17057 (2021). 32. john t. chang et al., a case of malingering: feigning a painful disorder in the presence of true medical illness, 1 pain med. 280, 280-82 (2000). 70 indiana health law review [vol. 20:63 medications two days after a four-inch incision was made into her abdomen. this decision was made because doctors had noticed that not giving strong opioids after surgery “facilitated a faster functional improvement,” a liberal term of neutrality with the function of self-service, as described by crt.33 she remembers not being able to sleep for almost three days after surgery due to pain, especially when changing the bloody bandages on her abdominal incision. jacqui had to brave through the pain, while not knowing that there were better options for pain management out there which were never offered to her. analyzing this from a clinical-research standpoint, under-treatment of jacqui’s pain, as a fourteen-year-old, during an episode of acute appendicitis, was not an anomaly, but it was a permanent norm described by crt.34 according to a study published in the journal of the american medical association (“jama”) pediatrics in 2015, researchers reviewed emergency room records across the u.s. of approximately one million patients below the age of twenty-one.35 specifically, patients who had moderate pain with appendicitis, found that about 43% of young white children and adolescents received analgesia of any type versus about 20.7% of young black children.36 for severe pain, only 12.2% of black children and adolescents received opioid analgesia, compared to 33.9% for white children and adolescents.37 after adjusting for confounding variables, the odds of a black child receiving opioid analgesia were one-fifth of that of a white child. although the researchers did not address why such disparity existed, this data is still eye-opening. arguments of drug abuse risk and diversion are presented to defend such practices, however, the likelihood of these risks occurring in young children is far less than in adults, and these risks do not justify under-treating a sick black child’s pain. this was a large study and appendicitis were the most common cause of acute abdominal pain in children,38 making this data very disturbing when considering intentional or implicit bias in healthcare settings, even in pediatric settings. there is clinical data showing that if pain is undertreated, it can lead to multiple long-term complications, including poor functional improvement after injury, higher rates of disability, poor healing, post-traumatic stress disorder (“ptsd”), and many other mood-related disorders including anxiety and depression.39 seeing the above trends of undertreatment of pain in black children, makes one wonder how much disability and long-term mental issues have been caused by the undertreatment of pain, which has led black children to be more 33. delgado & stefancic, supra note 18, at 18. 34. id. 35. monika k. goyal et al., racial disparities in pain management of children with appendicitis in emergency departments, 169 jama pediatrics 996, 996-1002 (2015). 36. id. 37. id. 38. joon sung kim, acute abdominal pain in children, 16 pediatric gastroenterology hepatology & nutrition 219, 219-24 (2013). 39. see benjamin morasco et al., the relationship between ptsd and chronic pain: mediating role of coping strategies and depression, 154 pain 609, 609-16 (2013). 2023] under-treatment of pain in black patients 71 dependent on others and deal with ptsd later in life. b. jacqui’s experience as a young black adult with pain moving further with jacqui’s clinical history, she continued to have sickle cell crises every few years, but fortunately, she was not admitted to the hospital again. jacqui completed high school and went to pursue a bachelor’s in education. jacqui also worked as a waitress in a local restaurant while attending college. one day, jacqui fell on her arm while carrying plates back to the kitchen. she heard a crack and a pop, followed by immense pain. jacqui immediately went to the emergency room where x-rays were done on her arm. the x-rays showed a dislocated fracture of the bones in her right forearm. jacqui was righthanded, so this was detrimental. according to the er physician, after years of suffering with sickle cell disease, jacqui’s bones became weak, which is often a common complication of this disease, and this was why a trivial fall led to an extensive fracture and dislocation. jacqui was again given over-the-counter medications and was sent home with a cast. a few weeks later, the x-rays showed non-healing of the fracture, and the surgeon decided that a surgery is necessary to address jacqui’s fracture. the weeks prior to the surgery, jacqui experienced excruciating pain. eventually, jacqui had the surgery, and a metal plate was placed in her forearm with five large screws to realign the fractured bones. but again, post-operatively, jacqui was not given opioid analgesics for pain. she talked to her nurse, who told her that the doctor had not placed any strong pain medication orders for her. the next day, she talked to the rounding surgeon about being placed on stronger pain medications. the physician said that he did not think that she needed strong pain medications, because she is a young lady and can “brave through this temporary pain, because she will be back to being brand new in three to four weeks.” she believed the surgeon’s word and went home the next day taking some mild over the counter analgesics at home, even though her pain was unbearable after the surgery. she tried physical therapy, but the pain prevented her from moving her arm, so she took some time off from her work and education to regain her strength and recuperate from the injury and the surgery. she was young and motivated, but the healing process took six months, and the over-thecounter pain medications did not help much. she went back to live with her mother, and after twelve months, she started back with school, which did not make sense to her, since the surgeon had told her that she would be back to normal in three to four weeks. by this time, her forearm and hand muscles had become very weak, and she could not write much. fortunately, over the next eighteen months after surgery, she eventually gained most of her strength, but it took a total of eighteen months rather than the three to four weeks as she was told. now, coming back to the research on management of fracture and trauma associated pain in black patients, there is reasonable data showing that like pediatric appendicitis issues, the trauma and fracture related pain is significantly 72 indiana health law review [vol. 20:63 undertreated in black patients compared to white patients.40 a study published in annals of emergency medicine in 2000 showed that black patients were less likely to receive pain medications in the er for extremity fractures—57% in black patients versus 74% in white patients.41 also, the use of stronger opioids in black patients was much less when compared to white patients for very similar upper or lower extremity fractures.42 there is also the issue of long-term loss of function, as it happened with jacqui. there is evidence that jacqui was undertreated for her pain, which led to her not getting appropriate physical therapy for her arm, causing muscle wasting and lower functional improvement. this led her to not only be in pain, but also lose a year of school, in addition to not being able to work and having to move back to her mother’s place in trenton, new jersey. from a financial and employment standpoint, this was loss of income for her for a year after graduation, and loss of a teacher from the work force for a whole year, had she completed her degree on time. but as the study above shows, again, such discriminatory behavior is a norm, and not an anomaly, as seen through the lens of crt. from another angle of crt, this is where the intersectionality of being a black woman also played a part, there is data that will be discussed in the coming sections about how this intersectionality further worsens the issue of undertreatment of pain in black women worse than black men.43 in addition to undertreatment, there is another factor that has been noted in average waiting times after arrival in emergency rooms across the united states a study published in pain management nursing journal found that even though the pain levels expressed by black patients were higher, their wait times for initial er treatment was significantly higher than for white patients.44 here, a few questions arise. first, whether white patients treated earlier because of their race, in what crt describes as white privilege or whiteness as a property. second, whether these are delay tactics or implied biases against black patients, where their pain is not considered as important of an issue to treat. we talk more about this issue further below in the section related to the history of disparity in pain management in black patients. c. jacqui’s experience during childbirth as a black woman after completing college, jacqui got married, and gave birth to tanisha at the age of twenty-four. jacqui remembers her eighteen-hour long process of labor, 40. knox h. todd et al., ethnicity and analgesic practice, 35 annals emergency med. 11, 11-16 (2000). 41. id. 42. id. 43. charles s. cleeland et al., pain and treatment of pain in minority patients with cancer: the eastern cooperative oncology group minority outpatient pain study, 127 annals internal med. 813, 813-16 (1997). 44. erlinda wheeler et al., level of pain and waiting time in the emergency department, 11 pain mgmt. nursing 108, 108-14 (2010). 2023] under-treatment of pain in black patients 73 having cramping labor pains, and not being offered epidural injection/drip for pain. she remembered asking the nurse for pain medications to help with the pain, but she was told that her obstetrician had not placed an order for it. when she talked to her obstetrician about pain control, she was told that most black women are able to give birth without pain medications, and there was risk of her being drowsy with strong pain meds that would prevent her from herself pushing the baby out efficiently. although she wanted to believe the obstetrician, but now she was old enough to understand these pain undertreatment issues for herself, having been through prior experiences as a child with sickle cell disease and appendicitis, and later as an adult with an arm fracture. she had started to feel like she was not a preferable candidate for receiving analgesia for her medical issues. but instead of raising this issue further, she decided to stay positive through labor, mustered up courage, and went through eighteen hours of painful labor to deliver tanisha. she felt like during this process of extensive pushing, she had damaged her back, which felt sore after delivery, but the doctor told her that it was temporary, and she should “. . . just put some ice on it, since that’s how they treat such pain now,” again using liberalism as a shield (as described by crt) to cover for systemic inadequacies in pain management. she went home, continued to work, and raise her daughter with her very supportive husband. the data on the use of labor analgesia shows the same pattern of undertreatment of pain in black patients.45 a study published in anesthesiology journal in 2007 showed that the odds ratio for a black woman to receive epidural analgesia is 0.78 compared to their white counterparts.46 similarly, postpartum, there is clinical evidence of undertreatment of pain for black women when compared to white women who were given more liberal opioid analgesia after similar child births.47 d. jacqui’s pain issues one year post childbirth as a black woman jacqui’s back pain continued to get worse after the birth of tanisha. being up at night nursing her daughter, and working as a teacher during daytime, she was on her feet all day. she felt like the pain, which was initially in the lower back, started shooting down her left leg. she initially ignored it, but later when she felt that her leg was becoming numb at times and getting somewhat weaker in strength than her right leg, she decided to go see a specialist. jacqui talked in detail about her limiting pain, and the functional issues related to her pain, and she was given similar advice on reducing her weight and applying ice. she tried it, but it was not helpful. three months later she fell at work when her left leg suddenly gave out. she went to the er, and after a long 45. laurent g. glance et al., racial differences in the use of epidural analgesia for labor, 106 anesthesiology 19, 19-25 (2007). 46. id. 47. nevert badreldin et al., racial disparities in postpartum pain management, 134 obstetrics & gynecology 1147, 1147-53 (2019). 74 indiana health law review [vol. 20:63 delay, she got an mri scan of her spine that showed a lumbar spine disc bulge and rupture that was pressing on the nerves coming down into her left leg. she was asked why she did not report this earlier, since she could have significantly avoided disability. she talked about talking to her obstetrician and then to a pain management specialist who did not do any imaging to see her spine. physical therapy was ordered for her. it took jacqui another six months of physical therapy after getting a back surgery to get improvement in her leg strength and to walk without support. she remembers this being a very tough time, having to deal with an infant, working full time, and dealing with this horrible pain and leg weakness. jacqui’s experience over this time again reminds us of intersectionality between race and gender where being a black woman probably led to her undertreatment/mistreatment on multiple levels. to understand poor management of back pain from vertebral/spinal causes in black patients, we look at the data from spine journal, who published a study in 2003 on the relation of race to outcomes and the use of healthcare services for lower back pain.48 this study showed significant disparities in pain care for black patients compared to white patients, even when black patients reported higher pain and disability; black patients’ concerns were often invalidated by clinicians.49 this study also showed that physicians believed that black patients are less likely to have back pain and spine issues compared to white patients, and thus get less imaging, clinical care, and corrective surgeries for said issues. 50 e. jacqui’s cancer diagnosis and pain management as a black woman jacqui continued her teaching job for another sixteen years. around this time, her daughter had left for college. a few months later, jacqui felt pain in her back, but this time her pain was in a different area. jacqui was more tired and fatigued, and, as a result, visited her primary care physician. her physician once again concluded that the pain is resulting from work stress and told her to take tylenol. about two weeks later, jacqui felt short of breath and went to the local emergency room. there, jacqui spoke about her fatigue, and pain issues. a scan showed a large lesion in her thoracic (central) spine, along with some small lesions in her ribs. soon after, jacqui went through a full body scan, which showed presence of cancer in her breast, with further spread into her bones, liver, and lungs. jacqui was informed that although she was not in a curative stage, chemotherapy may prolong her survival. despite her serious condition, jacqui felt that her pain was not adequately treated. here we look to expert panels, and specialty-based organizations who agree that cancer pain should be adequately treated with opioids, especially when the disease is advanced, or widespread (metastatic).51 because cancer pain (due to 48. timothy s. carey & joanne mills garrett, the relation of race to outcomes and the use of health care services for acute low back pain, 28 spine 390, 390-94 (2003). 49. id. 50. id. 51. shalini dalal & eduardo bruera, pain management for patients with advanced cancer 2023] under-treatment of pain in black patients 75 cancerous lesions) is severe based on its underlying cause, and because most patients are considered terminal in advanced cancers, so the fear of long-term addiction potential is much lower than general population because of limited expected lifespan.52 this is further evidenced by very low (much lesser than noncancer pain) numbers of abuse/diversion related issues in research studies in these advanced cancers.53 but unfortunately, the disparity of undertreatment of black patients with advanced cancers is witnessed in this specific arena as well. a study done on outpatient pain showed that minority and black patients continued to show higher pain levels, morbidity and disability due to cancer pain compared to majority white patients.54 however, only 35% of these patients were given adequate analgesia for cancer pain, compared to 50% in majority white patients.55 again, minority women were the worse hit group with pain undertreatment,56 reminding us of intersectionality as discussed in critical race theory.57 similar outcomes were shown in a study done by vallerand et al. that was published in 2005 in pain medicine journal.58 this study showed that in addition to higher pain levels and disability showed by black patients while being undertreated, there was much higher apprehension in black patients regarding perception of control over their pain in these dire circumstances.59 pain centers in the brain are closely linked to mood areas in the brain, and data has shown that higher level of pain increases acute and long-term issues with anxiety, depression, and insomnia in patients.60 so, in a way, undertreatment of pain further worsens the mood and sleep, which studies show is linked eventually to higher mortality.61 the bottom line is that by under-treatment of pain in black patients, we are increasing their mental health issues and leading to higher disease related mortality in these patients. there have been multiple studies that show that black patients with cancer have lower survival rates, and lower rates of curative treatments. 62this is also true in other chronic illnesses like hypertension, diabetes mellitus, and hiv, where black patients continue to have worse outcomes than white patients.63 so, in the opioid epidemic era, am. soc’y. clinical oncology educ. book. 24, 24-35 (2019). 52. id. at 25. 53. id. 54. cleeland et al., supra note 49, at 816. 55. id. 56. id. 57. see delgado & stefancic, supra note 40. 58. april hazard vallerand et al., disparities between black and white patients with cancer pain, 6 pain med. 242, 242-50 (2005). 59. id. 60. marloes mjg gerrits et al., pain, not chronic disease, is associated with the recurrence of depressive and anxiety disorders, 14 bmc psychiatry 7 (2014). 61. id. 62. id. 63. alliance for health reform, closing the gap: racial and ethnic disparities in healthcare, 96 j. nat’l med. ass’n 436, 436-40 (2004). 76 indiana health law review [vol. 20:63 this problem is widespread in other diseases as well, showing that the healthcare system as a whole continues to fail black patients as a whole. this again verifies the crt tenet that racism is permanent and widespread in the us. f. first meeting with jacqui – and attempts to improve pain and symptoms care after multiple failed treatments, jacqui came to our cancer center and pain clinic for comprehensive cancer care, and to enroll on a trial. in our first meeting with her, we found her to be a kind and knowledgeable person. she was up to date with all her medical records, and even though she was very weak and had lost almost thirty pounds of weight over the last six months or so, she was still able to manage all her affairs, and had continued to teach in her school remotely via online classes with covid restrictions. she still had a great sense of humor, even though she understood that this was her final chance at slightly prolonging her survival. she was still praying with her daughter daily, who had moved back home, and had been a great support to her through these tough times. jacqui also felt that her religiosity and spirituality helped her cope well with the stressors of her illness. but her un-managed pain continued to be a huge stressor for her. she was still using over-the-counter tylenol, and ibuprofen tablets, which she felt were not very helpful, and rated her pain 8/10 when she walked, which significantly limited her functional status and mobility. before she was offered the clinical trial, we told her about the very low likelihood of the clinical trial helping her cancer, but she replied, ‘. . . i know that i may not be here in the next few months, but i feel strength through my spirituality, and even though this clinical trial may not work for me, but my participation in this trial will give important information to the researchers, which will be helpful for the next generation of breast cancer patients. so, i see participating in this trial more to give back to the world, rather than getting benefit myself at this stage . . .’ to our team, it was an extremely powerful gesture. this woman, who had been mistreated in all walks of healthcare system throughout her life as a young child, to an adolescent, then to an adult with multiple medical issues, where she was discriminated against via multiple intentional and implied biases, she still wanted to give back to the same healthcare system. we sat down and talked about her history for over two hours and got all the information narrated in above sections through her life. there were times, when her pain prevented her from being comfortable, but she wanted to make sure that she could answer all questions, that were required for her clinical trial candidacy. we looked at her scans and saw that cancer her invaded all through her body, and had also spread into various bones, and even had caused multiple fractures in her spine. based on her pain levels, and according to the nccn guidelines,64 we decided to start her on low dose oxycodone 5-10 mg orally every four hours 64. robert a. swarm et al., adult cancer pain, version 3.2019, nccn clinical practice guidelines in oncology, 17 j. nat’l comprehensive cancer network 977, 977-1007 (2019). 2023] under-treatment of pain in black patients 77 as needed for her pain and gave her a prescription for 180 tablets for managing this pain. since she had never been on long-term opioid pain meds previously and had no medication or drug abuse issues in the past, we had no concerns regarding any risk of misuse at this point. later that day, jacqui and tanisha took the prescription to a local chain pharmacy in their inner-city locality. the pharmacist told them they did not have this medication, so they went to another chain pharmacy, and got a similar response. this was odd, but they went to a few other pharmacies that were a little further away in their locality, and each pharmacy gave them the same response. finally, they asked a worker at the pharmacy why every pharmacy was turning them away, and he told them that due to high risk of getting robbed, and issues with disposal, almost no pharmacies in their city carried controlled opioid pain medications. this was very surprising to them, so they called our clinic with the request to find a pharmacy where they could take this prescription to get it filled. we recommended a suburban chain pharmacy where most of our local patients got their controlled scripts filled. they went there, and within ten minutes, their prescription was filled. she called us back, to thank us for this help with finding a pharmacy. this issue of pharmacies in predominantly black neighborhoods not carrying important opioid pain medications is not new, but it has continued to worsen over time. a study by camren green, found that black patients faced significant difficulty in finding opioid pain medications in their local pharmacies.65 this issue was previously brought up by a study done by sean morrison, which found that over 50% of new york pharmacies did not carry opioid pain medications in mostly black neighborhoods.66 similarly, a detroit news survey67 of hundreds of pharmacies in southeastern michigan found that filling opioid pain medications prescriptions was much easier in suburban white neighborhoods than in black inner-city neighborhoods. they also found that the likelihood of suburban pharmacies carrying certain long-acting opioid medications was four times higher than pharmacies in poor black communities.68 when asked for an explanation, pharmacists gave three chief reasons for this issue, one being inadequate supplies provided to these pharmacies, especially in bigger pharmacy chains’ secondly, high risk of illicit use; and thirdly, having a high risk of theft.69 this issue puts the legitimately sick patients with cancer in a very precarious situation, something that jacqui and her daughter experienced first-hand in their own city. again, this rings a bell with crt tenet of ‘whiteness as property’ and white privilege – 65. camren r. green et al., the unequal burden of pain: confronting racial and ethnic disparities in pain, 4 pain med. 277, 277-94 (2004). 66. r. sean morrison et al., "we don't carry that"--failure of pharmacies in predominantly nonwhite neighborhoods to stock opioid analgesics. 342 new eng. j. med. 1023, 1023-26 (2000). 67. j. kurth et al., painkiller drugs scarce for the poor, the detroit news (oct. 27, 2002). 68. id. 69. id. 78 indiana health law review [vol. 20:63 where if you live in a white neighborhood, you are likely to easily get pain medications just for living there. iv. historical overview of poor medical care in black patients, and subsequent mistrust of healthcare system by the black community now that we clearly see the problem on multiple levels as with jacqui’s case, we move into the historic issues with healthcare, that have led to this very obvious disparity in healthcare provision for black patients, resulting in their subsequent justified mistrust in the healthcare system in general. unfortunately, u.s. healthcare history is tainted with a long history of mistreatment of black patients, and their exploitation in the name of healthcare. most notorious among them is the ‘tuskegee study’, which took place between 1932-1972 by the united states public health services (usphs) and the centers for disease control (cdc).70 in this study, more than 400 black men with syphilis were intentionally not treated with proper antibiotics for treatment of syphilis to see the long-term complications of this disease, even when there was ample data for their efficacy in treating syphilis.71 almost 100 black men died due to this intentionally untreated disease, and many others were infected through further sexual contact.72 although there is evidence that such practices in not treating/undertreating back patients was common, but this being a federally funded trial managed by federal agencies is considered one of the most blatant abuse of black people via discriminatory practices in healthcare settings.73 although there have not been more reports of similar trials since tuskegee trial’s intentional discrimination was made public, but there is significant active evidence that black patients healthcare needs are not fulfilled at the same level as white patients.74 as stated above, there is a much higher incidence of complications and death in black patients from chronic diseases like diabetes, hypertension, and ischemic heart disease.75 similarly, the incidence and complications from infectious diseases like hepatitis c, and hiv (human immunodeficiency virus) are much greater in black patients.76 this has subsequently led to significant differences in average life span of a black person when compared to average lifespan of a white person in the us.77 this widespread disparity confirms the first tenet of crt, that points to the 70. the tuskegee timeline, cdc, https://www.cdc.gov/tuskegee/timeline.htm [https://perma. cc/v459-tkkf] (last visited oct 20, 2021). 71. id. 72. id. 73. id. 74. alliance for health reform, supra note 64. 75. id. 76. id. 77. julie bosman et al., u.s. life expectancy plunged in 2020, especially for black and hispanic american, n.y. times (july 21, 2021), https://www.nytimes.com/2021/07/21/us/ american-life-expectancy-report.html [https://perma.cc/qbl2-vuqr]. 2023] under-treatment of pain in black patients 79 permanence of racism in the us. data suggests that black patients receive less aggressive treatments when compared to white patients in similar circumstances.78 in addition, there is data that black patients are more likely to be offered less preferred treatment options like amputations than white patients.79 this goes in line with pain management as well, where we see that black patients are commonly under-treated for their pain related issues in different clinical settings. earlier papers in medical journals talked openly about ‘peculiarities’ including thick skulls, less sensitive nervous system with respect to pain.80 dr. samuel cartwright in his 1851 paper ‘report on the diseases and physical peculiarities of the ne*%o race’, wrote that blacks bore a specific “ne*%o disease [making them] insensible to pain when subjected to punishment.”81 similarly, many physicians believed well into recent times, that blacks could tolerate surgical procedures with little or no pain at all, and they did not need anesthetics to be administered.82 although, such inaccuracies are, hopefully, not taught anymore in graduate medical education, but many students still believe that black patients are biologically different from white patients.83 a study done by hoffman et al. at the university of virginia, showed that a large percentage of undergraduate, graduate medical student, and some of the medical residents when asked about difference in black and white body structures, agreed to the statement that black patient’s nerve-endings (receptors for pain perception) were less sensitive to pain than whites, and black patients’ skin was thicker than white patients’ skin, so they feel lesser pain.84 such reductive thinking falls into the terms of essentialism which is well described as a tenet of critical race theory (as discussed in part ii). there has been extensive experimental research data that has dispelled such false evidence-less myths. a study done by lipton et al.,85 at the columbia university medical center in ny, published in journal of social science & medicine in 1986 showed that there were no such differences in between different ethnicities, and patients from all ethnicities and racial backgrounds perceived equal sensations of pain.86 to understand the cause of such large discriminatory discrepancy, we must look at the grass root levels of us healthcare systems, and the factors associated with development of these pre-conceived notions by clinical providers towards black patients. a study done by aranowitz et al., published in journal of 78. id. 79. id. 80. samuel a. cartwright, report on the diseases and physical peculiarities of the negro race, 7 new orleans med. & surgical j. 691, 691-715 (1851). 81. id. 82. martin pernick, a calculus of suffering: pain, professionalism, and anesthesia in nineteenth century america page cited (colum. univ. press, 1986). 83. hoffman et al., supra note 7. 84. id. 85. james lipton & joseph marbach, components of the response to pain and variables influencing the response in three groups of facial pain patients, 16 pain 343, 343-59 (1983). 86. id. 80 indiana health law review [vol. 20:63 advanced nursing in 2019, explored the factors that influenced clinical decision making.87 the factor that stood out most prominently was a clinicians ‘assumed criminality of black patients.88 further analysis in this study found that recent news and media attention on ‘opioid crisis’ in the us and its ‘war on drugs’ made connections between black people who are incarcerated 6 to 10 times more for substance-related crimes in the us compared to white people.89 such skewed data and information makes people believe that black people were more active in such substance related criminal issues. but data shows that black and white people use drugs at the same rates in the us.90 based on such common representations, clinicians who were earlier told that opioids prescribed by them were the ‘gateway drugs’ felt that there was a higher risk of abuse and diversion when these medications were given to black patients, so they became more reluctant in giving pain medications and other controlled substances to these patients.91 another detail that makes things worse via entertainment media is the significantly higher proportion of negative characters, gang members, and drug offenders that are portrayed by black actors.92 this is probably another medium through which general population and even clinicians get influenced by feeling that there is high likelihood that black patients will have more criminal tendencies towards use of their narcotic medications. v. legal analysis of racially discriminatory practices toward pain management now the issue is getting clearer that clinicians are obviously not giving adequate analgesia to black patients; so, are there repercussions for such clinical mismanagement? upon expansion of this question, we get a few more focused questions. firstly, does this add any liability or malpractice issue for their discriminatory acts? secondly, what is the law and legal precedent on this issue, and is something being done about it? if no to the above inquiries, then thirdly, are there any guidelines or case precedent relating to disciplinary action from medical boards or some other governing medical agencies on such 87. aronowitz et al., supra note 2. 88. id. 89. criminal justice fact sheet, naacp, https://naacp.org/resources/criminal-justice-factsheet [https://perma.cc/s6jh-ruca] (last visited oct. 20, 2021). 90. german lopez, black and white americans use drugs at similar rates. one group is punished more for it., vox (oct. 1, 2015), https://www.vox.com/2015/3/17/8227569/war-ondrugs-racism [https://perma.cc/ln6e-cgbv]. 91. julie netherland & helena b. hansen, the war on drugs that wasn't: wasted whiteness, “dirty doctors,” and race in media coverage of prescription opioid misuse., 40 cult med. psychiatry 664, 664 (2016). 92. zachary crockett, “gang member” and “thug” roles in film are disproportionately played by black actors, vox (sept. 13, 2016), https://www.vox.com/2016/9/13/12889478/blackactors-typecasting [https://perma.cc/xza5-32tq]. 2023] under-treatment of pain in black patients 81 discrimination? we look at these specific questions below under the following legal analysis section. a. malpractice liability for clinicians for undertreating black patient’s pain? we did a detailed literature search on this issue on westlaw and lexisnexis and looked at medical regulations and case law. the short answer is that, theoretically, a clinician can be asked why they did not provide adequate analgesia to a patient under certain circumstances, but there are many defenses that a clinician can raise, and successfully quash any such concerns.93 we further explore this issue below. legally, when looking at malpractice liability as a tort action, we look at the four elements of such an action. 1. a professional duty was owed to the patient here the patient proves that he was owed a professional duty, and will present how they were in pain, and the clinician did not provide coverage for that pain. however, we know that with pain being very subjective without much objective evidence, a clinician can raise the defense that they did not believe certain factors that the patient presented qualified them for certain pain medications. in addition, they can put in findings that would show that there was a high likelihood that patient was feigning, their pain was not real, or there was a high risk of ulterior motives of medication misuse by patient. expert witnesses can be brought in, but there is a good likelihood that clinicians spot judgement on this case will be given precedence here, especially when public policy programs like ‘opioid crises, and ‘war on drugs’ are heavily funded and backed by federal and state legislatures. 2. breach of duty in this element, the patient will say that their pain was not treated, and it was breach of duty. the above clinician defense presented in element 1) will likely still stand for this as well and quash any basic arguments for this element. 3. above breach led to injury in this element, the patient will argue that say that a certain pain and suffering was caused by the breach, but in the likely absence of element 1) and 2) above, it will not go this far into the third element. 93. david brushwood, failure to provide adequate pain relief, medscape (apr. 24, 2009), https://www.medscape.com/viewarticle/591048 [https://perma.cc/z6kd-yw3d]. 82 indiana health law review [vol. 20:63 4. damages again, unlikely after unproven elements 1) and 2), the court will even look to this element. looking at westlaw and lexisnexis for cases of undertreatment of pain specifically in black patients or minorities did not reveal any relevant case law. so clearly, there is minimal reprimand for the clinician in these circumstances for their undertreatment of pain, which as we noticed above caused significant injury to our patient jacqui. moreover, there are adequate federal and state laws that stress more on not providing opioid pain medications when the clinician deems it inappropriate, and ‘feels’ (extremely subjective) that there is a risk of abuse and diversion. clinicians are also provided objective tools like ort (opioid risk tool),94 and soappr (screener and opioid assessment for patient and painrevised),95 which ask for subjective information, and clinician can easily use these tools to their defense in undertreating or not treating pain for any patient. sadly, however, on the flip side there is a large case precedent on reprimands and successful malpractice suits for clinicians when they inappropriately prescribed. in addition, although initial case data was mostly related to civil and other malpractice issues, more-recent cases have been charged under criminal statutes for death of a patient due to incorrect prescribing habits.96 this element of fear, when combined with assumed criminality in black patients leads to more discriminatory undertreatment of pain in these patients. b. what are the laws and legal precedent on this issue? here, we look at the laws, and their scarcity or disparity that leads to this potential discriminatory treatment process. historically, medicare and medicaid are covered under the title vi of the civil rights act of 1964,97 which was instrumental in desegregation, especially in healthcare settings where often black and white patients at the time were not even allowed to be in the same room.98 it provided that for eligibility in such federal programs, the hospitals and healthcare systems under this payment 94. lynn webster & rebecca webster, predicting aberrant behaviors in opioid-treated patients: preliminary validation of the opioid risk tool, 6 pain med. 432, 432 (2005). 95. stephen butler et al., validation of the revised screener and opioid assessment for patients with pain (soapp-r), 9 j. pain 360, 360 (2008). 96. arielle dollinger & mihir zaveri, doctor who prescribed pain pills is charged with 5 counts of murder, n.y. times (mar. 5, 2021), https://www.nytimes.com/2021/03/05/nyregion/ george-blatti-overdose-deaths.html [https://perma.cc/fe3t-4w2k]. 97. 42 u.s.c. § 2000(d) (prohibiting exclusion from participation in, denial of benefits of, and discrimination under federally assisted programs on ground of race, color, or national origin). 98. philip r. lee, battling for the right health policy, then and now, 39 generations: j. am. soc’y on aging 15, 15-20 (2015). 2023] under-treatment of pain in black patients 83 umbrella could not racially discriminate among patients.99 nevertheless, as in other legal issues, going down to the state legislation, the picture becomes very murky with different laws that indirectly effect the quality of pain management, and the level of clinician discretion, especially when applied to pain management. we look at some of these laws below. under the concern of opioid abuse epidemic, state laws have developed a strict oversight on opioid usage for pain, although abuse and pain management are completely different issues. however, since both issues involve the same opioid or opioid based pain medications, unfortunately they fall under the same umbrella of state oversight. for example, in new jersey, since 2019, the law n.j.s.a. 36:2-367, which is named as ‘knock out opioid abuse day’, states that october 6th will be known as this day, and education will be given to healthcare care workers, lawmakers, and general public about the harms of opioids.100 such efforts and laws even if passed for eventual good, impact the prescription practices of the clinicians, and makes them biased towards certain minorities. among the same lines, some states have further made laws on how much opioid pain medications can be provided to patients, and for how may days. alaska, for example, has state law § 08.68.705, known as ‘maximum dosage for opioid prescriptions’, which puts above restrictions on prescription of opioids for pain for nurse practitioners.101 on the contrary, there are also some rare state laws that push for adequate analgesia for patients, and provide accommodating rules for clinicians in those states to provide adequate analgesia for their patients in pain. for example, in california, § 725 provides immunity from disciplinary actions for physicians and surgeons in treating intractable pain with opioid medications while in compliance with other related laws.102 the underlying theme for this rare state law was a pain management issue between an internist dr. wing chin, and a terminal patient mr. william bergman.103 dr. chin was accused of undertreating mr. bergman’s pain and causing him to suffer. the case went to trial, and jury reached a $1.5 million verdict against dr. chin.104 the thing that made this case different was the fact that an advocacy group ‘compassion in dying’ filed suit on the patient’s behalf to push for this discrepancy. but, prior to that medical board of california had declined to bring disciplinary action against dr. chin.105 as stated above, this was an isolated case. however, under the usual clinical circumstance, there is no liability for the clinician for undertreatment of pain. going back to our case about undertreatment of pain in black patients. in a case from new york, verley v. goord,106 the court 99. id. 100. n.j. stat. ann. § 36:2-367 (west 2022) (“knock out opioid abuse day”). 101. alaska stat. § 08.68.705 (2019) (“maximum dosage for opioid prescription”). 102. cal. bus. & prof. code § 725 (2022). 103. jeffrey wishik, chronic pain: medical and legal aspects, 53 r.i. bar j. 23, 23 (2004). 104. id. 105. id. 106. verley v. goord, no. 02civ.1182, 2004 wl 526740 at *21 (s.d.n.y. jan. 23, 2004); see also verley v. goord, no. 9:05-cv-1251, 2008 wl 4279498 at *13 (n.d.n.y. sept. 15, 2008). 84 indiana health law review [vol. 20:63 stated that plaintiff did not have grounds for damages for undertreatment of pain under the reasoned equal protection clause, since pain is not covered by the language of the clause. similarly, in a louisiana case, state v. kennon, the court addressed the issue of a discretion-based rule that could be used by district authorities to change charges against narcotic abuse related issues.107 however, the records in this case showed that the use of this law was strongly biased against black people by the authorities108. this racial bias in pain management and oversight does not just go unilaterally against black patients, but it also goes against black clinicians. this issue was raised by dr. ernest bonner, a black pain management doctor in california against rita aid pharmacy.109 in bonner v. rite aid corporation, 202 wl 2836487, dr. bonner accused rite aid pharmacies to be discriminating against him and not filling prescriptions for this patients, even though he had followed all the regulatory laws, and had all necessary documentation for such prescriptions for his patients.110 he stated that white doctors in the area prescribed more opioid pain medications, but he was isolated and discriminated against by virtue of his race.111 again, this was a very subjective issue, and the burden of proof was too high for him to prove through data and statistics.112 but this clearly shows a bias directed even towards black clinicians in the field of pain management. c. availability of guidelines relating to disciplinary action from medical boards for such discrimination? as above, there was not much in the realm of legal malpractice for undertreatment of pain, so we looked at state medical board statutes across the u.s. relating to this disparate practice.113upon our review, there were many common things in most of the regulations across states, such as all state medical boards required that clinicians do a thorough examination, and document their findings, and based on those findings make their decisions.114 similarly, most state medical boards talk about treating every patient without bias, and not to discriminate based on age, sex, race, or religion.115 107. state v. kennon, 194 so.3d 661 (la. app. 2d cir. 2016). 108. id. 109. bonner v. rite aid corporation, no. no. 2:19-cv-00674, 2020 wl 2836487 at *1 (e.d. cal. june 1, 2020). 110. id. 111. id. 112. id. 113. david e. joranson et al., pain management, controlled substances, and state medical board policy: a decade of change, 23 j. pain & symptom mgmt. 138, 143-45 (2002). 114. id. 115. fsmb statement on diversity, equity and inclusion in medical regulation and health care, fed’n state med. (apr. 15, 2021), https://www.fsmb.org/advocacy/news-releases/fsmbstatement-on-diversity-equ ity-and-inclusion-in-medical-regulation-and-health-care/ 2023] under-treatment of pain in black patients 85 regarding pain management, they often stress on appropriately treating pain, and some of them even use the word ‘suffering’ synonymously with pain. but again, they all lay much more stress, and provide clear guidelines on not overprescribing, and not prescribing for inappropriate reasons. similarly, there is significant case data that has been decided by state medical boards where clinician was deemed to be inappropriately prescribing, and was reprimanded for it by fines, probations, and even cancellation of medical licenses.116 so, this not only gives clinicians full control of the treatment of pain, but in various ways stresses them to preferably under-prescribe, or not prescribe at all for painful conditions. under these circumstances, most clinicians again connecting the dots with assumed criminality in black patients undertreat their pain habitually. this brings us to the next question. with all this press and social media drives in the age of twitter and open media, has there been a change recently in such practices? the short answer is ‘yes’. although a very limited, and a very superficial yes. on a federal level, federation of state medical boards (fsmb), put out a diversity, equity and inclusion statement in 2021 that affirmed its stance on above issues.117 similarly, ama in june 2021, put out its guidelines that confront systemic racism in medicine.118 however, as stated above, both efforts appear to be more outward statements with no legislative support on disciplinary actions relating to clinicians for their discriminatory acts. on a state level, california, 119 texas,120 and oregon121-122 have webpages on their efforts to prevent such discrimination and to file complaints. nevertheless, there is nothing linked to those pages on statistics related to the outcomes of such actions and complaints, which again unfortunately makes them just words at this point. therefore, after looking at legal tort-malpractice and state medical board regulations, and their existing case precedent, one can understand why such disparity exists resulting in undertreatment of pain in black patients. it clearly again falls under the first tenet of crt, that racism is permanent, and it’s all [https://perma.cc/8hbn-rgtd]. 116. jack richard & marcus m. reidenberg, the risk of disciplinary action by state medical boards against physicians prescribing opioids, 29 j. pain & symptom mgmt. 206, 206-07 (2005). 117. id. 118. ama adopts guidelines that confront systemic racism in medicine, ama (june 15, 2021), https://www.ama-assn.org/press-center/press-releases/ama-adopts-guidelines-confrontsystemic-racism-medicine [https://perma.cc/u87b-cxuh]. 119. dhcs's efforts to reduce health disparities, cal. dep’t health care servs. (may 23, 2022), https://www.dhcs.ca.gov/dataandstats/reports/pages/disparitiesinterventions.aspx [https://perma.cc/n3jd-nddy]. 120. filing a discrimination complaint, tex. health & hum. servs., https://www.hhs.texas. gov/about/your-rights/civil-rights-office/filing-a-discrimination-complaint [https://perma.cc/vk5lredj] (last visited aug. 26, 2022). 121. cultural competency, oregon.gov, https://www.oregon.gov/omb/topics-of-interest/ pages/cultural-competency.aspx [https://perma.cc/r8ll-3az5] (last visited nov. 12, 2022). 122. or. rev. stat.§ 676.850 (2021) (“mandatory cultural competency education”). 86 indiana health law review [vol. 20:63 around us, and the system propagates such practices to not only survive but thrive. vi. approaches to minimize discrepancy in pain management in black patients the first step to fixing any problem is to recognize that it’s a problem. so, recognizing that there is bias in management of black patients, especially in the field of pain management, will be the first step towards resolution of this dire problem.123 we already have enough data from multiple research papers and clinical studies that shows that undertreatment of pain is a widespread healthcare issue, rather than an isolated issue. there also has to be recognition that this is part of continuum of racism towards black patients, which is not as obvious as it was some decades ago, but it still plays a hidden yet important role in creating implicit biases that are often not visible to the clinicians themselves. a recent point of view paper published in new england journal of medicine by dr. oluwafunmilayo akinlade, talks about the need of clinicians to take the implicit bias test to get a better understanding of their unconscious underlying biases.124 as busy clinicians in busy clinics and hospitals, sometimes we need to sit down, take a moment, and reflect on our clinical encounters, and think through what the patient was trying to convey through his words and body language. so, clinically training clinicians in active listening exercises and improving their understanding of the patients’ issues is paramount.125 from a pain management standpoint, this is very important especially in emergency rooms and urgent care settings. there must be an understanding that like other patients, black patients come to these acute care centers for management of their acute issues, most often in severe distress, and allaying this distress at times can help get a better understanding of their deeper underlying clinical issues. similarly, such interventions should be made in pediatric settings where there is evidence of undertreatment of black children’s pain in acute settings. this will prevent ptsd and other long-term complications from poorly controlled pain, and hopefully create a better sense of trust in healthcare settings at a younger age.126 from a medical education and training standpoint, it is imperative to remove old myths regarding differences in black and white patients’ bodies and their perception of pain. these fallacies should be pointed out earlier as part of medical school curriculum, and actively dispelled to uproot any later clinical 123. david williams & toni rucker, understanding and addressing racial disparities in health care, 21 health care fin. rev. 75, 75 (2000). 124. oluwafunmilayo akinlade, taking black pain seriously, 383 new eng. j. med. 68 (2020). 125. ana-belén del río-lanza et al., information provision and attentive listening as determinants of patient perceptions of shared decision-making around chronic illnesses, 5 springerplus 1386, 1386-87 (2016). 126. aimee k. hildenbrand et al., posttraumatic stress in children after injury: the role of acute pain and opioid medication use, 36 pediatric emergency care 549, 557-58 (2020). 2023] under-treatment of pain in black patients 87 misconceptions.127 it is also very important to continue to collect data on the pain management disparity from an individual clinician basis to a large healthcare system basis. these internal audits will help these entities understand their flaws and help develop strategies to curb these issues with active education and training on an individual, and a system wide level. from a legal standpoint, there needs to be reprimand for clinicians for intentional undertreatment of black patients’ pain. better laws need to be passed to curb generalizations about black patients that lead to poor pain care of these patients. the presence of these regulations and following case precedent will help prevent poor pain management based on individual biases. in the same note, having similar regulations in state medical board guidelines with reprimands ranging from monetary fines and probations on medical licenses will likely prevent intentional discrimination towards black patients. it is also very important to remove stigma of drug seeking behavior from black predominant painful conditions like sickle cell disease. similarly, improving research funding for these diseases,128 and adding more education and training relating to these illnesses in medical curriculums will improve early diagnosis, clinical management of these diseases. also, improving pain scales which are more relevant to black populations, and using language in these scales which is more understandable and applicable to their conditions will help improve pain care for these patients. from a decision-making standpoint in managing these illnesses, rather than an individual discretion, team approach should be taken, so that one person’s individual implied or unconscious bias does not affect the pain treatments for black patients. over-portrayal of negative black characters in media that are involved in substance abuse, and drug paraphernalia should be corrected, since this causes further conscious and unconscious bias in clinicians and community members who then related black people to higher risk of criminality and illegal drug activities. from a healthcare access and delivery standpoint, improving medicaid payments (which are a more common source of insurance for black patients) will increase their acceptance by clinicians, which will subsequently improve quality of healthcare facilities for black patients.129 similarly, improvement in quantity and access towards mental health and substance recovery facilities, via improved funding will help reduce issues related to ptsd and mistrust relating to clinical 127. williams & rucker, supra note 102, at 85. 128. faheem farooq et al., comparison of us federal and foundation funding of research for sickle cell disease and cystic fibrosis and factors associated with research productivity, 3 jama network open 3, 8 (2020). 129. gideon lukens & breanna sharer, closing medicaid coverage gap would help diverse group and narrow racial disparities, center on budget & pol’y priorities, https://www.cbpp. org/research/health/closing-medicaid-coverage-gap-would-help-diverse-group-and-narrow-racial [https://perma.cc/56dn-9q5l] (revised june 14, 2021). 88 indiana health law review [vol. 20:63 care in black patients. in the same line, having all pharmacies carry opioid pain medication irrelevant of their locations in various parts of black neighborhoods or in white predominant suburbs will create a sense of equality among black patients who sometimes must travel long distances to get their medications filled for legitimate needs. most importantly, there is a great need for an increase in the number of black clinicians in the community and large healthcare systems. blacks make up for almost 14% of us population, but we only have 4% black physicians in the us,130 which is a huge discrepancy. improving pathways for black students to join medical schools and residency training programs will help resolve this issue over time. this will later also improve black leadership in hospitals and clinics which will hopefully improve the power balance, improve recognition of black patients’ clinical issues, and help larger healthcare systems better cater to the needs of black patients. conclusion coming back to our clinical case, we continued jacqui on oxycodone initially, and then added some long-acting morphine for her pain as well. she felt that with better pain control, she was able to walk more, eat better, and get more restful sleep at night. she was very thankful for the compassionate care, and appropriately liberal pain management. jacqui continued to come weekly to our clinic for the next 3 months, getting blood draws, clinical exams, and ct scans to see the response to the experimental clinical trial. she initially did well and was able to visit her sister in north carolina when covid-19 infection incidence decreased. she spent her birthday there with her husband, tanisha, and both her sisters. upon return from north carolina, she continued to do well for a few weeks. but later she started feeling short of breath and fatigued. we did blood draws and scans, and it showed that she was very anemic, and her disease had further spread in her liver and lungs. she later required oxygen for breathing comfortably. about 2 weeks later, we heard that she was getting weaker, and felt that she could not come to the cancer center for more treatments. we did a telemedicine visit with her via computer. she looked very weak and frail. tanisha told us that she had stopped eating a few days ago and was only able to sip some water. even with all this happening, she seemed to have her sense of humor, and said that she’ . . . talked to god last night, and he told her that he has a room for her in heaven . . .’. we talked to her and her family in more detail, and she said that she wanted to focus on comfort at this point. she also stated that she did not want to be placed on ventilators or other life support machines and wanted to go naturally and peacefully. we ordered some more morphine for her at home, in addition to 130. diversity in medicine: facts and figures 2019, ass’n am. med. cs., https://www.aamc.org/data-reports/workforce/interactive-data/figure-18-percentage-all-activephysicians-race/ethnicity-2018 [https://perma.cc/rzd3-d335] (last visited sept. 14, 2022). 2023] under-treatment of pain in black patients 89 requesting home hospice care. three days later, tanisha called us stating that jacqui had passed comfortably in her sleep, and she wanted our team to come in for her funeral service. we all went there after work on a thursday, and saw her resting comfortably in the open casket, looking blissful with a beautiful smile on her face. they had pictures of her with our team during her last six months, probably the toughest months of her life. but i think that she had seen tougher years growing up as a black girl with sickle cell disease, and appendicitis where no one acknowledged her pain, and later as an adult when her pain complaints after a large fracture and vertebral disc rupture were ignored. she braved through it all, the pain, the ignored complaints, and the subsequent suffering and disability. but she continued to serve her community as a schoolteacher even through all these troubling times. clearly, after all that she had been through her life, cancer was just a walk in the park for this brave lady. under recognition and under treatment of black patients’ pain is a sad reality for a healthcare system that prides itself in inclusion and liberalism. it is a national embarrassment for the us, that major health outcomes including adequate pain management for black patients are significantly poorer when compared to their white counterparts. this paper talks about discrepancies in pain management in various fields of medicine through the lens of tenets of crt. through the clinical case of jacqui, it describes various difficulties faced by black patients in getting their pain recognized, and adequately treated. by looking at these disparities in pain management for black patients through the tenets of crt, we can see that there is a huge need for grass root effort to recognize this disparity. in addition, there needs to be an improvement medical education system, healthcare funding, and research to correct the fallacies that bias clinicians in their pain management approaches when treating black patients. also, there needs to be improved mental health and substance abuse resources available for these patients who have been stigmatized and mistreated in the us healthcare system. in addition, there needs to be better perception of black people in media and news, where a new and more positive image needs to be portrayed to eliminate the currently displayed criminal portrayal that biases everyone including the healthcare providers. more importantly, there is a dire need for creation of pathways to improve representation of black physicians and healthcare leaders that help improve these discrepancies from top down. indiana health law review volume xvii 2020 number 2 articles a look back at the evolution of the family smoking prevention and tobacco control act and the present-day impact on “overlooked and belated issues”—electronic nicotine delivery systems (ends) and the youth epidemic, menthol, corrective statements and cigarette labeling graphic health warnings roseann b. termini* i. introduction although smoking has plagued the united states for generations, it was not until the past several years that smoking received more serious scrutiny.1 yet, the reality is that as far back as the 1960s, tobacco products posed a serious threat to * roseann b. termini, b.s. magna cum laude, m.ed. fellow, j.d., a food and drug law attorney, teaches several food and drug law courses at delaware law school, widener university and is the author of food and drug law: federal regulation of drugs, biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products www.fortipublications.com (2019). ms. termini dedicates this article to the memory of her parents who instilled values that fostered the determination to research and write about these significant issues as well as those employees at the united states food and drug administration who work in the area of tobacco products regulation, the national institutes of health and centers for disease control. she especially acknowledges ms. janet lindenmuth, m.s., research law librarian at delaware law school, who provided valuable research. ms. termini thanks her children and nonlawyer friends for reading earlier drafts of this article to help comport with plain language as much as possible considering the complexity of this area of law. finally, ms. termini thanks the indiana health law review editorial staff for their dedication. author contact rbtermini@widener.edu. portions of this article were previously published in the author’s book, roseann b. termini, food and drug law: federal regulation of drugs, biologics, medical devices, dietary supplements, personal care, veterinary and tobacco products (forti publications, 10th ed. 2019), www.fortipublications.com. 1. see generally roseann b. termini, food and drug law: federal regulation of drugs, biologics, medical devices, dietary supplements, personal care, veterinary and tobacco products 481 (10th ed. 2019). see generally roseann b. termini, the legal authority of the united states food and drug administration to regulate tobacco: calling on congress, 74 st. john’s l. rev. 63 (2000). 108 indiana health law review [vol. 17:107 human health as evidenced by the surgeon general’s report explaining that smoking causes cancer.2 fast forward to current times, the centers for disease control (“cdc”) has determined that over 1,300 people in the united states die each day due to smoking and over sixteen million americans have a disease attributed to smoking.3 the cdc concluded that in the united states, cigarette smoking is responsible for more than 480,000 deaths annually, and secondhand smoke exposure caused more than 41,000 of these deaths.4 these statistics do not just cover the older generations that many associate with smoking. over the years, the numbers in teen smoking statistics have escalated since the 1990s.5 based on cdc statistics, about 2,000 youth try their initial cigarette by age eighteen, and 200 youth become day-to-day smokers.6 this means that using current rates of smoking among youth, 5.6 million americans younger than eighteen years of age are expected to die prematurely from a smoking-related illness.7 this denotes about 1 in every 13 americans aged seventeen years or younger who are alive today.8 the center for tobacco products (“ctp”) within the united states food and drug administration (“fda”) regulates tobacco products with a mission of diminishing tobacco related deaths and diseases.9 since its creation, the ctp has maintained a critical mission on educating youth about the dangers of smoking.10 yet, teen use of 2. see the reports of the surgeon general: the 1964 report on smoking and health, u.s. nat’l libr. med. profiles science, https://profiles.nlm.nih.gov/ps/retrieve/narrative/nn/pnid/608 https://profiles.nlm.nih.gov/spotlight/nn/feature/smoking [https://perma.cc/3v86-kxry]. 3. smoking and tobacco use: diseases and death, ctr. for disease control and prevention, (feb. 6, 2019), https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/ index.htm [https://perma.cc/yl6j-uff5]. 4. id. 5. see regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents, 61 fed. reg. 44,398-99 (aug. 28, 1996) [hereinafter restricting]. in the 1990’s “[a]pproximately three million american adolescents . . . smoke . . . [cigarettes, while] an additional one million adolescent males use smokeless tobacco [products]. eighty-two percent of adults who . . . smoked . . . their first cigarette [did so] before the age of 18, and more than half . . . became regular smokers by that age.” 6. see the health consequences of smoking—50 years of progress: a report of the surgeon general, u.s. dep’t of health & human serv., 1, 6 (2014). see also smoking and tobacco use: youth and tobacco use, ctr. for disease control & prevention https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm [https://perma.cc/ce7y-cp6k]. 7. smoking and tobacco use: diseases and death, supra note 3. 8. see id.; the health consequences of smoking—50 years of progress: a report of the surgeon general, supra note 6, at 692. 9. center for tobacco products, u.s. food & drug admin., https://www.fda.gov/aboutfda/office-medical-products-and-tobacco/center-tobacco-products [https://perma.cc/4prz-6c3h]. 10. what cpt does, u.s. food & drug admin., https://www.fda.gov/tobacco-products/ about-center-tobacco-products-ctp/what-ctp-does [https://perma.cc/h2zu-t6qp]. 2020] the family smoking prevention and tobacco control act 109 tobacco related products has increased.11 the family smoking prevention and tobacco control act (“fsptca” or “tobacco act”) became law on june 22, 2009.12 this legislation conferred authority to the fda to regulate tobacco products.13 the fsptca amended the food, drug, and cosmetic act (“fdca”) and other federal laws by granting fda regulatory authority over tobacco products.14 this includes cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.15 yet, the fsptca, when enacted, was silent on issues of e-cigarettes and other electronic nicotine delivery systems (“ends”) and were eventually “deeming” as part of the fsptca.16 there are a myriad of matters concerning tobacco products regulation. however, this article highlights critical issues important to the public health in the united states. this article provides an overview of tobacco products regulation, including the fsptca. yet, issues persist such as undue delay in reissuing graphic warnings for cigarettes and lengthy legal battles over the language used in court-ordered corrective statements.17 further, the fsptca was silent on other tobacco products besides traditional cigarettes such as cigars, pipe tobacco, and 11. see generally smoking and tobacco use: youth and tobacco use, supra note 6. see also teresa w. wang et al., tobacco product use among middle high school students¾united states, 2011-2017, 67 morbidity & mortality wkly. rep. (mmwr) 629 (2018), https://www.cdc.gov/ mmwr/volumes/67/wr/mm6722a3.htm?s_cid=mm6722a3_w [https://perma.cc/h9rr-2x4p]. 12. family smoking prevention and tobacco control act, pub. l. no. 111-31, div. a, title i, 123 stat. 1776 (2009) (codified at 21 u.s.c. § 387 et seq (2012)). 13. id. 14. 21 u.s.c. §387a (2018) (“(a) in general¾tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 911, shall be regulated by the secretary under this chapter and shall not be subject to the provisions of chapter v”). 15. id. (“(b) applicability¾this chapter shall apply to all cigarettes, cigarette tobacco, rollyour-own tobacco, and smokeless tobacco and to any other tobacco products that the secretary by regulation deems to be subject to this chapter”). 16. see id. deeming tobacco products to be subject to the federal food, drug, and cosmetic act, as amended by the family smoking prevention and tobacco control act; restrictions on the sale and distribution of tobacco products and required warning statements for tobacco products, 81 fed. reg. 28,974 (may 5, 2016) [hereinafter deeming tobacco products]. 17. r.j. reynolds tobacco co., et al. v. food & drug admin., 696 f.3d 1205, 1218 (d.c. cir. 2012). the plaintiff tobacco companies alleged a violation of their free speech rights under the first amendment. preliminary injunction granted november 7, 2011, which effectively stayed the new graphic warnings from fda implementation. subsequently, the district court decided on february 29, 2012, that the government’s rule violated the tobacco companies’ rights to free speech and the fda filed an appeal. court of appeals for the district of columbia held that the fda failed to provide substantial evidence that graphic warnings on cigarette advertising would advance the government’s interest in smoking reduction to a material degree. 110 indiana health law review [vol. 17:107 ends including e-cigarettes.18 to overcome the lack of inclusion in the fsptca, deeming regulations were enacted.19 despite the deeming regulations, the use of tobacco products, including vaping and e-cigarettes, has escalated.20 finally, this article discusses the fda’s accomplishments along with further recommendations to stem the rise in youth use of e-delivery products. ii. the initial reluctance by the united states food and drug administration to regulate tobacco products and eventual acquiesce a. historical background of jurisdiction—therapeutic claims congress passed the federal cigarette labeling and advertising act in 1965, requiring warning labels on all cigarette packages.21 thereafter, congress banned cigarette advertising on television and radio.22 the surgeon general then started issuing more detailed warnings, which prompted the federal trade commission (“ftc”) to refine its labeling criteria to specifically reflect warnings about health consequences.23 the war on smoking evolved into a full-scale attack—including warnings from the surgeon general, ftc criteria to ensure warnings contained information on health consequences, and even state enactments of indoor clean air laws, such as pennsylvania’s clean indoor air act, which concerns smoking 18. deeming tobacco products, supra note 16, at 28,981. 19. id. 20. karen a. cullen et al., notes from the field: use of electronic cigarettes and any tobacco product among middle and high school students, 67 morbidity & mortality wkly. rep. (mmwr) 1276 (2018), https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm [https://perma.cc/vkm4-p2th]. 21. the federal cigarette labeling and advertising act, pub. law 89-92, 79 stat. 282 (1965) (required all cigarette packages to warn, “caution: cigarette smoking may be hazardous to your health”). yet congress did not provide the fda with the requisite jurisdiction to regulate tobacco products. 22. public health cigarette smoking act of 1969, pub. l. no. 91-222, 84 stat. 87. president richard nixon signed the public health cigarette smoking act on april 1, 1970, which banned cigarette ads from airing on television and radio. 23. see john e. calfee, cigarette advertising, health information and regulation before 1970, 1, 2 (f.t.c., working paper no. 134, 1985), https://www.ftc.gov/sites/default/files/ documents/reports/cigarette-advertising-health-information-and-regulation-1970/wp134.pdf [https://perma.cc/xc5w-l3y3] (stating some of these initiatives on cigarette advertising served as models for later ftc litigation and rule-making on advertising in general). examples are the advertising substantiation doctrine (implicitly applied in the 1955 cigarette advertising guides and the 1960 voluntary ban on tar and nicotine advertising, and later established through litigation) cases involving deception by omission and cases and rules based on the notion of “unfairness,” including ones where the 1964 draft trade rule on cigarette advertising served as the basis for the commission’s later explanation of how it would attack unfair practices. 2020] the family smoking prevention and tobacco control act 111 in public settings and certain workplaces. 24 the fda’s assertion of jurisdiction over tobacco products is intriguing. in united states v. 354 bulk cartons,25 the fda asserted jurisdiction over cigarettes that promised appetite reduction and subsequent weight loss.26 the district court determined that fda jurisdiction had been properly asserted where the manufacturer’s promises were based upon such weight reduction.27 the manufacturer intended the cigarettes to be used for therapeutic purposes.28 this court held that the intended use articulated by the manufacturer regarding therapeutic use satisfied the requisite intent of a drug under the fdca as a product intended to affect the structure and function of the human body.29 the fda also asserted jurisdiction in united states v. 46 cartons, etc., when a manufacturer claimed, in advertising leaflets, that cigarettes prevented respiratory infections, circulatory disease, and other physical ailments.30 these advertisements were sufficient to bring the cigarettes under the definition of “drug,” which is defined as a product intended to mitigate or prevent disease.31 24. see e.g. 35 pa. cons. stat. § 637.3 (2019) (regulating smoking in public settings and certain workplaces); la. rev. stat. ann. § 40:1291.11 (2019) (regulating smoking in public workplaces); mo. rev. stat. § 191.767 (2019) (prohibiting smoking in public places and meetings); nev. rev. stat. § 202.2491 (2019) (prohibiting smoking in public elevators, buildings, waiting rooms, stores, hotels, and buses); n.y. pub. health law § 1399-o (consol. 2019) (placing smoking restrictions, includes smoking and vaping, on auditoriums, elevators, gymnasiums, classrooms, and public transportation). 25. united states v. 354 bulk cartons trim reducing-aid cigarettes, 178 f. supp. 847 (d. n.j. 1959). 26. id. at 850 (stating a user can “[s]afely lose up to twenty pounds or double your money back”). 27. id. at 851. 28. id. 29. 21 u.s.c. § 321(g)(1) (2018) (“the term “drug” means (a) articles recognized in the official united states pharmacopoeia, official homoeopathic pharmacopoeia of the united states, or official national formulary, or any supplement to any of them; and (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (c) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (d) articles intended for use as a component of any article specified in clause (a), (b), or (c). a food or dietary supplement for which a claim, subject to sections 343(r)(1)(b) and 343(r)(3) of this title or sections 343(r)(1)(b) and 343(r)(5)(d) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. a food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (c) solely because the label or the labeling contains such a statement”). 30. united states v. 46 cartons, more or less, containing fairfax cigarettes., 113 f. supp. 336, 337 (d.n.j. 1953). 31. id. at 337-39 (“the term ‘drug’ means . . . articles intended for use in the diagnosis, cure, 112 indiana health law review [vol. 17:107 the fact that the fda only asserted jurisdiction when cigarette manufacturers promised increased health benefits, proved infuriating to action on smoking and health (“ash”), a citizen’s group.32 ash filed suit, pushing for the fda’s active assertion of jurisdiction over all tobacco products.33 however, the result disfavored ash because the 1980s litigation resulted in the determination that the fda lacked general jurisdiction over tobacco products.34 the court found no manifestation of the cigarette manufacturer’s intent “to affect the structure or any function of the body of man.”35 the fda agreed that it lacked general jurisdiction over tobacco products because ash had presented no evidence proving this requisite intent.36 the court’s significant point was that even though, at the time, the fda argued against jurisdiction, this could change in the future.37 thus, 46 cartons should be viewed as indicating the possibility of jurisdiction in the future, rather than as a total bar on fda jurisdiction indefinitely.38 mitigation, treatment, or prevention of disease in man or other animals . . . .”); see also 21 u.s.c. § 321(g)(1) (2018) (for the definition of “drug”); 21 u.s.c. § 321 (h) (2018) (“the term “device“ (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—(1) recognized in the official national formulary, or the united states pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. the term “device” does not include software functions excluded pursuant to section 360j(o) of this title”). 32. action on smoking & health (ash) v. harris, 655 f.2d 236, 237 (d.c. cir. 1980). see also termini, supra note 1, at 68. 33. action on smoking & health, 655 f.2d at 237 (1980) (discussing ash, along with thirteen other organizations and individuals, filed a citizen petition requesting that the agency assert jurisdiction over all cigarettes that contained nicotine). 34. id. at 239-40, 243 (quoting 21 u.s.c. § 321(g)(1)(c) (1980)) (the agency originally rejected ash’s request based on this lack of intent; the court agreed and denied the ash petition). see id. at 240 (discussing how the court agreed with this reasoning and denied the ash petition). see also id. at 243. 35. id. at 238. 36. id. at 237. 37. id. at 243. 38. see generally id.; nicotine in cigarettes and smokeless tobacco is a drug and these products are nicotine delivery devices under the federal food, drug, and cosmetic act: jurisdictional determination, 61 fed. reg. 44,619 (1996) [hereinafter jurisdictional determination]. 2020] the family smoking prevention and tobacco control act 113 b. the united states supreme court in brown stymied the 1996 regulations by rejecting fdas assertion of jurisdiction, yet this resulted in the enactment of the family smoking prevention and tobacco control act the fda asserted general jurisdiction over tobacco products only after the majority of health organizations acted in concert to declare nicotine’s harmful effects.39 in 2000, the jurisdiction issue was decided by the united states supreme court in fda v. brown and williamson tobacco corp.40 nearly a decade after brown, congress finally enacted the fsptca.41 critical to the analysis is that the fsptca does not provide the fda with the authority to ban tobacco products.42 however, the overall intent behind fda regulation is to ensure the safety of the american public.43 several factors contributed to the impetus of the fsptca, such as the rise of youth smoking, deaths associated with smoking, and the court’s decision in brown.44 however, in brown, the court held that the fda lacked the authority to regulate tobacco products.45 the fda had asserted jurisdiction over tobacco products based on the food drug and cosmetic act (“fdca”) definitions of “drug” and “device.”46 although the district court had agreed with the fda that the fda had jurisdiction to regulate tobacco products, in coyne beam, inc. v. fda, the court of appeals in brown and williamson tobacco corp. v. fda reversed.47 the united states supreme court affirmed the court of appeals’ 39. jurisdictional determination, supra note 38, at 44,634 (several organizations recognized the addictive nature of nicotine in tobacco products. the american psychiatric association began the movement in 1980, in which several organizations recognized the addictive nature of nicotine in tobacco products. since 1981, the u.s. surgeon general, the world health organization, and the american medical association, among others, submitted information to the fda regarding the addictive properties of nicotine). 40. food & drug admin. v. brown & williamson tobacco corp., 529 u.s. 120, 133 (2000) (holding that the fda does not have jurisdiction to regulate tobacco products). 41. family smoking prevention and tobacco control act, supra note 12. 42. see also 21 u.s.c. § 387g (“(3) limitation on power granted to the food and drug administration.—because of the importance of a decision of the secretary to issue a regulation— (a) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or (b) requiring the reduction of nicotine yields of a tobacco product to zero, the secretary is prohibited from taking such actions under this chapter”). 43. termini, supra note 1, at 3, 14. 44. see generally restricting, supra note 5; action on smoking & health, 655 f.2d at 237 (1980). 45. brown & williamson tobacco corp., 529 u.s. at 126 (2000) (holding that the fda does not have jurisdiction to regulate tobacco products). 46. see 354 bulk carton trim reducing-aid cigarettes, 178 f. supp. 847 (1959). 47. coyne beahm, inc. v. food & drug admin., 966 f. supp., 1374, 1379 (m.d. n.c. 1997), rev’d sub nom., brown & williamson tobacco corp. v. food & drug admin., 153 f. 3d 155 (4th 114 indiana health law review [vol. 17:107 decision.48 the court held that the fda lacked jurisdiction over tobacco products because congress did not confer such authority to the agency.49 the court denied fda jurisdiction over tobacco products due to fundamental conflicts and inconsistencies in prior actions by the fda and prior congressional inaction.50 despite the strong showing of compatible existing regulatory provisions and evidence of the danger of nicotine addiction, the court concluded that the fda lacked jurisdiction over tobacco products.51 the decision in brown and the national outcry for change spurred the impetus for the eventual passage of the fsptca.52 nearly ten years after brown, congress provided the fda with explicit legal authority and jurisdiction to regulate tobacco products.53 to that end, on june 22, 2009, former president obama signed the fsptca.54 this historic legislation conferred authority to the fda to regulate tobacco products.55 the fsptca amended the fdca and other federal laws by permitting fda regulatory authority over the manufacture, marketing, and distribution of tobacco products.56 initially, the fsptca included cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.57 finally, in may 2016, the fda issued what are identified as “deeming cir. 1998) aff’d 529 u.s. 120 (2000). 48. coyne beahm, inc. v. food & drug admin., 966 f. supp. 1374, 1379 (m.d. n.c. 1997); brown & williamson tobacco corp. v. food & drug admin., 529 u.s. 120 (2000). 49. brown & williamson tobacco corp., 529 u.s. at 126 (2000) (holding that the fda did not have jurisdiction to regulate tobacco products). 50. id. at 152. 51. id. at 161. 52. former president clinton announced an initiative to reduce youth smoking which contemplated the fda’s regulation of tobacco products under the food drug and cosmetic act. see remarks announcing the final rule to protect youth from tobacco, pub. papers 1,491-1,493 (aug. 23, 1996). see also david a. kessler et al., the food and drug administration’s regulation of tobacco products, 335 new eng. j. med. 991-93 (1996) (discussing the fda’s regulation restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents). 53. family smoking prevention and tobacco control act, supra note 12. 54. id. 55. id. in 2020, president trump proposed to remove the authority of the fda to regulate tobacco and instead create a separate federal agency. see jessie hellmann, trump administration proposes removing fda’s authority over tobacco regulation, the hill (feb. 10, 2020), https://thehill.com/policy/healthcare/482345-trump-administration-proposes-removing-fdasauthority-over-tobacco [https://perma.cc/8g8m-cq4w] 56. family smoking prevention and tobacco control act, supra note 12. 57. 21 u.s.c. § 321 (2018) (amended by adding at the end the following: ‘(rr)(1) the term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).’ (2) the term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g)).” 2020] the family smoking prevention and tobacco control act 115 regulations” to include regulation of e-cigarettes and other ends, as well as other covered tobacco products such as cigars and pipe tobacco.58 “covered tobacco product” means any tobacco product deemed subject to the fdca.59 however, as discussed above, years prior to the fsptca, when the fda attempted to regulate tobacco products, it was unsuccessful as illustrated in brown.60 the fda recognized that an outright ban was unrealistic, yet its focus even back in the 1990s was on the prevention of youth nicotine use.61 in 1996, the fda subsequently asserted jurisdiction to regulate tobacco products even though it previously had expressly disavowed such authority.62 the fda concluded that nicotine is a “drug” within the meaning of the fdca and that cigarettes and 58. see deeming tobacco products, supra note 16, at 29,874 (“summary ‘the food and drug administration (fda) is issuing this final rule to deem products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the federal food, drug, and cosmetic act (the fd&c act), as amended by the family smoking prevention and tobacco control act (tobacco control act). the tobacco control act provides fda authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the agency by regulation deems to be subject to the law. with this final rule, fda is extending the agency’s ‘tobacco product’ authorities in the fd&c act to all other categories of products that meet the statutory definition of “tobacco product” in the fd&c act, except accessories of such newly deemed tobacco products. this final rule also prohibits the sale of “covered tobacco products” to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your-own tobacco, and covered tobacco product packages and in advertisements. fda is taking this action to reduce the death and disease from tobacco products. in accordance with the tobacco control act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable”.) see also fda’s deeming regulations for e-cigarettes, cigars, and all other tobacco products, u.s. food & drug admin. (june 11, 2019), https://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htm#rule [https://perma.cc/xn8f-lwrd]. 59. family smoking prevention and tobacco control act, supra note 12, § 101. (“(a) definition of tobacco products—section 201 of the federal food, drug, and cosmetic act (21 u.s.c. 321) is amended by adding at the end the following: ‘’(rr) (1) the term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). ‘’(2) the term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g)’”). 60. see brown and williamson tobacco corp., 529 u.s. at 126 (2000) (holding that the fda lacked jurisdiction and hence could not implement the regulations at issue). see generally restricting, supra note 5. 61. restricting, supra note 5, at 13,227 (the fda posed an all-out war on teenage smoking through regulations enacted to curb the sale of tobacco to minors). 62. jurisdictional determination, supra note 38, at 45,216. 116 indiana health law review [vol. 17:107 smokeless tobacco are “combination products” that deliver nicotine to the body.63 the fda found that the best way to prevent addiction was to focus on thwarting children and teen’s attempts to smoke at a young age.64 accordingly, the fda determined that if “the number of children and adolescents who begin tobacco use can be substantially diminished, tobacco-related illness can be correspondingly reduced because data suggests that anyone who does not begin smoking in childhood or adolescence is unlikely ever to begin.”65 besides requiring retailers to verify age of purchasers through photo identification younger than 27, the 1996 regulations prohibited the following: “[s]ale of cigarettes or smokeless tobacco to persons younger than 18; however in 2020 legislation was enacted that raised the minimum age to purchase tobacco to twenty-one; sale of cigarettes in quantities smaller than 20; distribution of free samples; and sales through selfservice displays and vending machines except in adult-only locations.”66 however, the court in brown stymied the authority of the fda to regulate tobacco products.67 after the brown decision rejected the 1996 regulations regarding fda assumption of jurisdiction, the fsptca was finally enacted.68 the congressional findings of the fsptca are critical to understanding the fda’s objective of preventing youth from smoking which has remained steadfast over the years.69 the findings illustrate how in enacting the fsptca, congress relied on the 1996 regulations that brown struck down due to lack of jurisdiction.70 back in 1996, e-cigarettes were not in the united states marketplace and consequently not on the radar of congress nor the fda.71 apparently, what occurred in enacting the fsptca in 2009 was congressional reliance on the 1996 regulations as evidenced in the congressional findings.72 63. id. at 45,217-18. 64. restricting, supra note 5, at 44,398-99. the fda found that 82% of adult smokers had their first cigarette prior to age 18, and over half became regular smokers by 18. the fda found a similar issue regarding smokeless tobacco. 65. id. at 44,399. 66. id. at 44,616-17, 44,396 (the regulations additionally prohibited outdoor advertising within 1,000 feet of any public playground or school; prohibit the distribution of any promotional items, such as t-shirts or hats, bearing the manufacturer’s brand name; and prohibit a manufacturer from sponsoring any athletic, musical, artistic, or other social or cultural event using its brand name). (21 u.s.c. 387f(d)). pub. law 11696 sec. 603 (2019). 67. brown & williamson tobacco corp., 529 u.s. at 126 (2000) (holding that the fda does not have jurisdiction to regulate tobacco products and hence could not implement the 1996 regulations). 68. family smoking prevention and tobacco control act, supra note 12. 69. see generally 21 u.s.c. § 387 note (findings) former fda commissioner gottlieb has reiterated the stance to prevent youth smoking. 70. see generally 21 u.s.c. § 387 (finding 7). brown & williamson tobacco corp.,529 u.s. 120 (2000). 71. see generally restricting, supra note 5 (providing a comprehensive analysis of nicotine status in the united states, but without commenting on the use of e-cigarettes). 72. see generally 21 u.s.c. § 387 note (findings). 2020] the family smoking prevention and tobacco control act 117 all of the congressional findings are relevant and significant; however, for purposes of this article, the congressional findings reveal that congress focused the 2009 tobacco act on prevention of youth tobacco use and specifically found the 1996 regulations comported with first amendment principles.73 the fsptca congressional findings reveal the focus on the prevention of youth smoking.74 these findings are relevant to understand the deeming of other nicotine products and the current momentum to prevent youth from getting hooked on nicotine at such an early, vulnerable age.75 undoubtedly, the fda’s stance, as far back as the 1990s, as well as later legislation, namely the fsptca, reaffirms the commitment by the fda to prevent youth from smoking.76 hence, the fda’s present focus is neither unforeseen nor novel. iii. the evolution of e-cigarettes into the united states market and the overlooked electronic nicotine delivery systems (ends) the congressional findings were well-defined in terms of focus, namely, to prevent youth from smoking.77 yet, where do ends, such as e-cigarettes, fit in the scheme of fda regulation? the plausible reason for the omission of ends in the 2009 fsptca is, that at the time the fsptca was enacted back in 2009, e-cigarettes were a relatively new phenomenon in the united states market.78 regrettably, despite the fsptca congressional findings and the 1996 regulations, smoking by youths is on the rise again though with a different nicotine delivery system, namely e-cigarettes.79 a historical timeline of an e-cigarette nicotine inhaler details that they were possibly introduced in the united states in the mid-2000s.80 interestingly, the fda argued that e-cigarettes were drug-device combination products and/or 73. 21 u.s.c. 387f (2018). 74. 21 u.s.c. § 387 note (findings). 75. id. (findings 1, 3, 23, 2)). 76. id. (findings 5, 6). 77. id. 78. u.s. dep’t of health and human serv, e-cigarette use among youth and young adults: a report of the surgeon general, at i, 9 (2016), https://e-cigarettes. surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf [https://perma.cc/bfg8mnec] [hereinafter use among youth]. 79. id. at vii, 6-7. see also appendix a. 80. a historical timeline of electronic cigarettes, consumer advocates for smoke free alternatives ass’n, http://www.casaa.org/historical-timeline-of-electronic-cigarettes/ [https:// perma.cc/j82u-hlal]. see generally soterra, inc. v. food & drug admin., 627 f.3d 891, 893 (d.c. cir. 2010); use among youth, supra note 78, at 10; the tariff classification of a nicotine inhaler and parts from china, ny m85579 (2006), https://rulings.cbp.gov/search?term=m85579& collection=all&sortby=relevance&pagesize=30&page=1 [https://perma.cc/87rh-cjbv]. see also appendix b. 118 indiana health law review [vol. 17:107 drugs rather than tobacco products.81 for example, in correspondence to the electronic cigarette association, the fda deemed e-cigarettes as combination products, subjecting them to center for drug evaluation and research (“cder”) as the primary regulator and a new drug application review process (“nda”).82 the fda stated that despite the legal authority to regulate tobacco products under the 2009 fsptca, the e-cigarettes, noted in the warning letters, and similar products fell within the definitions of drugs and devices under the fdca, with a drug primary mode of action.83 electronic cigarettes are products designed to deliver nicotine or other substances to a user in the form of a vapor.84 “electronic cigarettes are battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide.”85 typically, they are composed of a rechargeable, battery-operated, heating element, a replaceable cartridge that may contain nicotine or other chemicals, flavor, and an atomizer that, when heated, converts the cartridge contents into vapor.86 the user can then inhale this vapor.87 these products are manufactured to appear similar to cigarettes, cigars, and pipes.88 they are sometimes also created to appear like ordinary items, like pens or usb memory sticks. 89 electronic cigarette marketers touted different flavors such as chocolate and mint, yet hopefully fda will use enforcement authority in this regard.90 81. soterra, 627 f.3d at 894-95 (2010). 82. letter from janet woodcock, dir., ctr. for drug evaluation & res., to matt salmon, president, electronic cigarette ass’n, (sept. 10 2010), https://www.femaflavor.org/sites/default/ files/electronic%20cigarette%20association%20-%20letter%20to%20industry.pdf [https://perma.cc/nzd4-99ep]. (the electronic cigarette association is now defunct). 83. soterra, 627 f.3d at 894-95 (2010) (rehearing en banc denied jan. 24, 2011); letter from janet woodcock, supra note 82; 21 u.s.c. § 321(g), (h), (p) (2018). see generally, combination products: therapeutic and diagnostic products that combine drugs, devices, and/or biological products, u.s. food and drug admin., http://www.fda.gov/combinationproducts/ default.htm [https://perma.cc/c4z9-3r7q]. 84. vaporizers, e-cigarettes, and other electronic nicotine delivery systems (ends), u.s. food and drug admin. https://www.fda.gov/tobaccoproducts/labeling/productsingredients components/ucm456610.htm [https://perma.cc/v5mg-rul9] [hereinafter ends]. see also soterra, 627 f.3d at 893 (2010). 85. soterra, 627 f.3d at 893 (2010). 86. id.; vaporizers, e-cigarettes, and other electronic nicotine delivery systems (ends), supra note 84. 87. vaporizers, e-cigarettes, and other electronic nicotine delivery systems (ends), supra note 84. 88. id. 89. id. 90. id. see also path study findings give insight into flavored tobacco, health effects of e-cigarettes, and adult use of cigars and hookah, u.s. food & drug admin. (june 19, 2019), https://www.fda.gov/tobacco-products/ctp-newsroom/path-study-findings-give-insight-flavoredtobacco-health-effects-e-cigarettes-and-adult-use-cigars [https://perma.cc/h6nm-6msg]. see u.s. food & drug admin., enforcement priorities for electronic nicotine delivery system 2020] the family smoking prevention and tobacco control act 119 the surgeon general’s report enumerated the health consequences of electronic cigarettes: 1. “nicotine exposure during adolescence can cause addiction and can harm the developing adolescent brain.”91 2. “nicotine can cross the placenta and has known effects on fetal and postnatal development. therefore, nicotine delivered by e-cigarettes during pregnancy can result in multiple adverse consequences, including sudden infant death syndrome, and could result in altered corpus callosum, deficits in auditory processing, and obesity.”92 3. “e-cigarettes can expose users to several chemicals, including nicotine, carbonyl compounds, and volatile organic compounds, known to have adverse health effects. the health effects and potentially harmful doses of heated and aerosolized constituents of e-cigarette liquids, including solvents, flavorants, and toxicants, are not completely understood.”93 4. “e-cigarette aerosol is not harmless “water vapor,” although it generally contains fewer toxicants than combustible tobacco products.”94 5. “ingestion of e-cigarette liquids containing nicotine can cause acute toxicity and possibly death if the contents of refill cartridges or bottles containing nicotine are consumed.”95 a. product classification settled by the smoking everywhere, inc. decision the decision in smoking everywhere, inc., paved the path for product classification of e-cigarettes.96 in smoking everywhere, inc., the district court found that electronic cigarettes were tobacco products under fsptca.97 on appeal, the question before the soterra court was “whether congress has authorized the food and drug administration (“fda”) to regulate e-cigarettes under the drug/device provisions of the federal food, drug, and cosmetic act (ends) and other deemed products on the market without premarket authorization (2020), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcementpriorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market [https://perma.cc/4grt-5z23]. see also fda finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint, u.s. food & drug admin. (jan. 2, 2020), https://www.fda.gov/ news-events/press-announcements/fdafinalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children [https://perma.cc/4kl3-n6d8]. 91. use among youth, supra note 78, at 5. 92. id. at 7. 93. id. 94. id. 95. id. 96. see generally smoking everywhere, inc. v. united states food and drug admin., 680 f. supp. 2d 62 (d.d.c. 2010). 97. id. at 73. 120 indiana health law review [vol. 17:107 (“fdca”), 21 u.s.c. § 351 et seq., or under the family smoking prevention and tobacco control act of 2009” (the “tobacco act” or fsptca).98 in soterra, the court grappled with the issue of “whether brown & williamson’s reading of the fda’s authority under the drug/device provisions of the fdca applies only to tobacco products for which congress has passed specific regulatory statutes or whether it extends to all tobacco products as customarily marketed.”99 the court of appeals affirmed the district court’s decision.100 the court in soterra held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the fsptca and are not drugs/devices unless they are marketed for therapeutic purposes.101 the court’s reasoning was based on the intended use set forth by the manufacturer.102 the company stated that njoy is marketed as a “pleasure product” and not for therapeutic purposes.103 therefore, the fda lacked authority under fdca’s drug/device provisions to regulate tobacco products customarily marketed without claims of therapeutic effect.104 the fda has the authority to regulate tobacco products customarily marketed without claims of therapeutic benefit under the fsptca.105 this means that a company would not have to submit an application under the parameters for human drug approval and the parameters for medical devices. this distinction is critical as both the drug approval processes and medical device approval processes are at best lengthy processes.106 the soterra decision effectively permitted sottera to market and distribute e-cigarettes under the brand name njoy for pleasure purposes under the fsptca. 107 b. evolution of the deeming rule—covered tobacco products regulation overall, the fda’s concern over electronic or e-cigarettes has stemmed from safety issues as well as marketing and promotion to youth.108 for example, in 2009, the fda notified healthcare professionals and patients that a laboratory analysis of electronic cigarettes found that they contain carcinogens and toxic 98. soterra, 627 f.3d at 892 (2010). 99. id. at 895. 100. id. at 899. (pending appeal, smoking everywhere voluntarily withdrew its complaint against fda. id. at 893. see smoking everywhere, inc. v. food & drug admin., no. 10-5032, 2010 wl 3260117 (d.c. cir. aug. 13, 2010)). 101. id. at 895. 102. id. at 897-98. 103. id. at 893. 104. id. 891. 105. id. at 900. 106. see generally 21 u.s.c. §§ 355, 360e (2018); see also learn about drug and device approvals, u.s. food & drug admin (june 18, 2019), https://www.fda.gov/patients/learn-aboutdrug-and-device-approvals [https://perma.cc/22v5-2nc9] 107. smoking everywhere, inc., 680 f. supp. 2d at 73 (2010). 108. see generally food & drug admin v. brown & williamson tobacco corp., 529 u.s. 120 (2000). 2020] the family smoking prevention and tobacco control act 121 chemicals such as diethylene glycol, an ingredient used in antifreeze.109 further, the fda issued warning letters in 2010 to certain manufacturers of electronic cigarettes for violations of the fsptca due to unsubstantiated claims and poor manufacturing practices, such as varying amounts of nicotine or cartridges with nicotine, yet labeled without nicotine. warning letters were sent to: gamucci america (smokey bayou, inc.); e-cig technology, inc.; e-cigarettedirect, llc; johnson creek enterprises, llc; and ruyan america, inc.110 finally, six years after the warning letters were issued, the fda issued a deeming final rule which includes e-cigarettes and other ends within the fda’s authority to regulate under the fsptca.111 yet, despite the relatively recent marketplace entry, youth are using these products at an alarming rate.112 c. youth epidemic and fda initiatives a theme throughout the conundrum of tobacco products regulation is the focus on prevention of youth smoking of traditional tobacco products and ecigarettes and other ends. this was evident for years as illustrated by the 1996 regulations that were challenged in fda v. williamson.113 several years elapsed before congress finally gave the fda jurisdiction to regulate tobacco by enacting the fsptca and, included in the congressional findings, notice of the constitutionality of the 1996 regulations as well as the concern of youth smoking.114 echoing a similar concern regarding youth smoking and e-cigarettes, 109. u.s. food & drug admin. consumer health info., fda warns of health risks posed by e-cigarettes, http://alaskaquitline.com/wp/wp-content/uploads/2016/06/fdaconsumerupdates-e-cig.pdf [https://perma.cc/kq49-wdfu]. see also cnn, fda and health experts warn against use of e-cigarettes, cnn (july 22, 2009), http://www.cnn.com/2009/ health/07/22/ecigarettes.fda/index.html [https://perma.cc/9ruc-3rzb]. 110. see webmd, fda warns five companies over e-cigarette claims, cbs news (september 10, 2010), https://www.cbsnews.com/news/fda-warns-five-companies-over-e-cigaretteclaims/ [https://perma.cc/e4wr-vrft]. these warning letters are achieved at: https://www. archive-it.org/collect ions/7993?q=gamucci+america+%28smokey+ bayou%2c+ in c .% 2 9 &sh o w = ar c h iv e d p a g e s &h i t s p e r d u p e = 0 & g o = s e a r c h + t h e+ arch ive [https://perma.cc/d42b-ahwf]. 111. deeming tobacco products, supra note 16, at 28,937. 112. use among youth, supra note 78; cullen et al., supra note 20. as mentioned, e-cigarettes are a relatively novel phenomenon in the united states. a historical timeline of an e-cigarette nicotine inhaler details that they were first introduced in the united states in the mid-2000s. see a historical timeline of electronic cigarettes, supra note 80. see also the tariff classification of a nicotine inhaler and parts from china, supra note 80. see also appendix b. 113. brown & williamson tobacco corp. v. food & drug admin., 529 u.s. 120 (2000). (holding that fda lacked jurisdiction yet upholding the 1996 regulations). the congressional findings in the 2009 fdptca specifically address the constitutionality of the 1996 regulations. 21 u.s.c. §. 387 note (finding 30). 114. 21 u.s.c. § 387 note (findings 30-32) (relying on and incorporating the 1996 regs). 122 indiana health law review [vol. 17:107 youth who use e-cigarettes are using them frequently, and addiction is an issue.115 further, the flavors are attractive to youth.116 perhaps e-cigarettes would not appeal to youth if unflavored.117 this issue is fraught with the potential for dire consequences and is quite complex. for example, unlike how cigarettes are the prime delivery device for tobacco, e-cigarettes present an entirely different pattern in terms of delivery devices.118 this latest phenomenon concerns the proliferation of flavored e-cigarettes with names that appeal to youth and, arguably, “cookie box” names and flavors are meant for youth rather than adults.119 despite the fsptca and deeming regulations, the reality is that marketing to youth has occurred most recently with ends products.120 marketing to youth poses a concern about the impact on our youth, who possibly could 115. bonnie halpern-felsher, karma mckelvey, mike baiocchi, adolescents’ and young adults’ use and perceptions of pod-based electronic cigarettes, 1 jama network open e183535 (2018), http://doi.org/10.1001/jamanetworkopen.2018.3535 [https://perma.cc/9rc8mhp2]. according to the authors, “electronic cigarettes (e-cigarettes) are the most commonly used tobacco product among adolescents and young adults. further, pod-based e-cigarette devices could subject both adolescents and young adults at increased risk for polytobacco use and nicotine dependence.” the authors refer to the juul® company website, “each juul pod is designed to contain approximately 0.7 ml with 5% nicotine by weight at time of manufacture which is approximately equivalent to 1 pack of cigarettes or 200 puffs.” id. (citing information that can now be found at: how much nicotine is in a juulpod?, juul, https://support.juul.com/hc/enus/articles/360026223453-how-much-nicotine-is-in-a-juulpod[https://perma.cc/gtp3-myuc]. see also teens using vaping devices in record numbers, nat’l inst. on drug abuse (dec.17, 2018), https://www.drugabuse.gov/news-events/news-releases/2018/12/teens-using-vaping-devicesin-record-numbers [https://perma.cc/zxk7-aymv]. the increased vaping rates between 20172018 comport with the cdc/fda government-funded national youth tobacco survey. see youth tobacco use: results from the national youth tobacco survey, u.s. food & drug admin., https://www.fda.gov/tobaccoproducts/publichealtheducation/protectingkidsfromtobacco/uc m405173.htm [https://perma.cc/6dcd-ulz5]. see also richard miech, adolescent vaping and nicotine use in 2017–2018 — u.s. national estimates, 380 new eng. j. med. 192 (2019). dr. miech, notes “the one-year increases in the prevalence of nicotine vaping translate into almost 1.3 million additional adolescents who vaped in 2018 in comparison to 2017.” vaping among youth in 2019 increased to 5.4 million. see smoking and tobacco use: youth and tobacco use, supra note 6. 116. halpern-felsher, mckelvey & baiocchi, supra note 115, at 9. youth are attracted to the fruit and mint flavors. 117. see id. 118. id. 119. see e.g., durbin to e-cigarette industry: gummy bear-flavored liquid nicotine helps adults quit smoking? prove it, dick durbin united states senator illinois (july 30, 2018), https://www.durbin.senate.gov/newsroom/press-releases/durbin-to-e-cigarette-industry-gummybear-flavored-liquid-nicotine-helps-adults-quit-smoking-prove-it[https://perma.cc/7h53-5lz5]. 120. see alisa a. padon, erin k. maloney & joseph n. cappella, youth-targeted e-cigarette marketing in the us, 3 tobacco reg. sci. 95 (2017). 2020] the family smoking prevention and tobacco control act 123 experience health consequences during their teen years and as adults.121 d. a matter of ethics and perceived curtailment yet use by youth soars interestingly, some silicon valley investors swiftly decided not to fund juul labs inc. (“juul®”), in part for ethical reasons; however, they did fund cannabis companies, perhaps due to stated health benefits of medical marijuana.122 juul® has revamped its website and marketing strategy to focus on smoking cessation and the chief executive officer of juul® stepped down and was replaced by a former executive from the altria group, inc., which owns approximately $13 billion stakes in juul®.123 a question remains: is this too little too late? nevertheless, possibly due to voluntary compliance and/or fda action, companies that market to youth might consider otherwise.124 the altria tobacco conglomerate discontinued the sale of several flavored e-cigarettes, such as strawberry brulee, apple cider, and hazelnut cream, and at the end of 2018, altria invested $12.8 billion to acquire a 35 percent stake in juul®.125 121. mark sampson, researchers explore health effects of e-cigarettes, u.s. dep’t of health and human res. (nov. 6, 2018), https://www.hhs.gov/blog/2018/11/6/researchersexplore-health-effects-of-ecigarettes.html [https://perma.cc/gna4-xfem]. see also isaac ghinai et al., characteristics of persons who report using only nicotine-containing products among interviewed patients with e-cigarette, or vaping, product use–associated lung injury — illinois, august–december 2019, 69 morbidity & mortality wkly. rep. (mmwr ) 84, 88 (2020), h ttps://www.cdc.gov/mmwr/volumes/69 /wr/mm6903e1.h tm?s_cid=mm6903e1_w [https://perma.cc/qm8q-95ng]. 122. see erin griffith, silicon valley investors shunned juul, but back other nicotine startups, n.y. times (oct. 8, 2018), https://www.nytimes.com/2018/10/07/technology/silicon-valleyinvestors-juul-nicotine-start-ups.html [https://perma.cc/2ghg-9ark] (revealing though that some investors might not have invested due to the market share not being large enough for profits. cannabis start-ups have raised $1.1 billion). 123. id. see also juul® newsprint advertisement, phila. inquirer, sept. 27, 2018, at a7. see also juul® newsprint advertisement: warning to parents, phila. inquirer, oct. 14, 2018 at a12. see aimee pichee, juul ceo shakeup includes halt on advertising in u.s., moneywatch (sept. 25, 2019, at 7:27pm), https://www.cbsnews.com/news/juul-ceo-kevin-burns-steps-downreplaced-by-altria-executive/ [https://perma.cc/bkx3-eqyd]. see also timothy annett, juul labs ceo to step down after vaping backlash, bloomberg (sept. 25, 2019, at 7:45am), https://www.bloomberg.com/news/articles/2019-09-25/juul-labs-ceo-to-step-down-amid-growingvaping-backlash [https://perma.cc/kd9b-46s5]. 124. see e.g., jennifer maloney, altria will pull its e-cigarette pods from the market, wall st. j. (oct. 25, 2018), https://www.wsj.com/articles/altria-will-pull-its-e-cigarette-pods-from-themarket-1540471369 [https://perma.cc/d584-gm2m]. altria ceo howard willard wrote a letter to fda regarding this initiative. see letter from howard a willard iii, ceo, altria, to scott gottlieb, former u.s. food & drug admin. comm’r (oct. 25, 2018), https://perma.cc/ged843kv. 125. griffith, supra note 122. the $12.8 billion investment in juul® declined in value to 124 indiana health law review [vol. 17:107 originally altria planned to continue marketing for juul® but decided otherwise126 yet, by way of illustration, when altria decided to discontinue altria’s green smoke and mark ten brands, they represented a minor portion of the e-cigarette market.127 by contrast, juul®, who sells online, in retail vape stores, and convenience stores (including those with gas stations), represents a much larger market share of over 70 percent.128 the increased use of ends by youth has escalated and has hooked teenagers.129 the fda and the cdc data from the 2018 national youth tobacco survey indicate a significant increase in the use of ends by youth.130 for example, from 2017 to 2018, there was a 78 percent increase in e-cigarette use among high school students and a 48 percent increase among middle school students.131 the total number of youth, including middle school and high school students, that use e-cigarettes increased from 3.6 million in 2018 to 5.4 million in 2019.132 suffice it to state, the fda mandate is that of public health and specifically to prevent youth tobacco addiction.133 the fda’s comprehensive plan for tobacco and nicotine regulation, issued in 2017 and affirmed in 2018, focuses on youth tobacco and nicotine prevention.134 the youth prevention plan’s purpose is threefold: “preventing youth access to tobacco products; $4.1 billion as of dec. 31, 2019. jennifer maloney, altria takes $4.1 billion charge on juul investment, (january 30, 2020) https://www.wsj.com/articles/altria-takes-4-1-billion-writedown-onjuul-investment-11580386578 [https://perma.cc/43g7-638k] 126. maloney, supra note 125. see also infra note 127. 127. maloney, supra note 124. according to maloney, altria represented 5.6% of the united states’ e-cigarette market excluding online sales for the four weeks. altria reports 2019 fourthquarter and full-year results; provides 2020 full-year earnings guidance; revises 2020 2022 adjusted diluted eps growth objective; revises terms of juul transaction, altria group, inc. http://investor.altria.com/file/index?keyfile=402520678 [https://perma.cc/hq94-5mqb]. 128. maloney, supra note 124. according to maloney, juul® represents a 74.5% share of the united states market. 129. jan hoffman, one drag on a juul® hooked a teenager for years, n.y. times (nov. 16, 2018), https://www.nytimes.com/2018/11/16/health/vaping-juul-teens-addiction-nicotine.html [https://perma.cc/3w59-xcfz]. 130. cullen et al., supra note 20. 131. id. 132. smoking and tobacco use: youth and tobacco use, supra note 6. see also statement from fda commissioner scott gottlieb, m.d., on new data determining rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use, u.s. food & drug admin. (feb. 11, 2019), https://www.fda.gov/news-events/press-announcements/ statement-fda-commissioner-scott-gottlieb-md-new-data-demonstrating-rising-youth-use-tobacco [https://perma.cc/wp29-npe2]. https://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm631112.htm 133. fda’s comprehensive plan for tobacco and nicotine regulation, u.s. food & drug admin., https://www.fda.gov/tobacco-products/ctp-newsroom/fdas-comprehensive-plan-tobaccoand-nicotine-regulation [https://perma.cc/wl7y-ar29]. 134. id. 2020] the family smoking prevention and tobacco control act 125 curbing marketing of tobacco products aimed at youth; and educating teens about the dangers of using any tobacco product, including e-cigarettes, as well as educating retailers about their key role in protecting youth.”135 enforcement has increased. by way of illustration, the fda issued over 1,300 warning letters to tobacco retailers for selling tobacco products, such as ecigarettes, e-liquids, and cigars to minors and since 2010, the fda issued approximately 1,800 violations against the walgreen company for selling ecigarette products to minors.136 further, the fda has increased inspection of ecigarette manufacturers and seized documents.137 in 2018, former fda commissioner gottlieb issued statements about the epidemic regarding the use of e-cigarettes by youth, and the agency issued a youth tobacco prevention plan including that of enforcement.138 the fda and ftc have joint coordination concerning the promotion of e-cigarettes that resemble candy, cookies, and juice boxes.139 further, a hearing was held in late 2018 to discuss efforts to eliminate youth e-cigarette use, focusing on the potential role of drug therapies to support 135. fda’s youth tobacco prevention plan, u.s. food & drug admin., https://www.fda. gov/ tobacco-produ c t s /you th -an d-tobacco / fdas-youth-tobacco-preven tion -p lan [https://perma.cc/pl4p-9yaw]. 136. fda takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access, u.s. food & drug admin. (sept. 11, 2018), https://www.fda.gov/news-events/pressannouncements/fda-takes-new-steps-address-epidemic-youth-e-cigarette-use-including-historicaction-against-more [https://perma.cc/yy5t-eqyd]; ftc, fda take action against companies marketing e-liquids that resemble children’s juice boxes, candies, and cookies, fed. trade comm’n (may 1, 2019), https://www.ftc.gov/news-events/press-releases/2018/05/ftc-fda-takeaction-against-companies-marketing-e-liquids [https://perma.cc/a78f-3abq]. statement from fda commissioner scott gottlieb, m.d., on new steps to address epidemic of youth e-cigarette use, u.s. food & drug admin. (sept. 11, 2018), https://www.fda.gov/news-events/press-announcements/ statement-fda-commissioner-scott-gottlieb-md-new-steps-address-epidemic-youth-e-cigarette-use [https://perma.cc/tax7-welr]. ); see, e. g., letter from scott gottlieb, m.d., commissioner, u.s. food & drug admin, to richard ashworth, president of operations, walgreen co. (mar. 4, 2019), https://www.fda.gov/media/122587/download [https://perma.cc/m63k-4j87]. 137. jennifer maloney, fda conducted surprise inspection of juul’s headquarters, wall street j. (oct. 2, 2018), https://www.wsj.com/articles/fda-conducted-surprise-inspection-of-juulsheadquarters-1538496393 [https://perma.cc/wzj8-2m73] (addressing the seizure of documents from juul® labs). see also jan hoffman, f.d.a. seizes documents from juul headquarters, n.y. times (oct. 2, 2018) (addressing the seizure of documents from juul® labs as well). 138. statement from fda commissioner scott gottlieb, m.d., on new steps to address epidemic of youth e-cigarette use, supra note 136; fda’s youth tobacco prevention plan, supra note 135. 139. fda, ftc take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies, u.s. food & drug admin. (apr. 30, 2018), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm605507.htm [https://perma.cc/q2b7-466w]. 126 indiana health law review [vol. 17:107 cessation and the issues impacting the development of such therapies.140 former fda commissioner gottlieb announced implementation procedures to restrict youth access to flavored products (except mint, menthol and tobacco flavors), both at retail establishments and online and acting fda commissioner ned sharpless has reinforced this stance and a guidance document was issued shortly after fda commissioner hahn was confirmed.141 states such as new york have attempted to ban flavored e-cigarettes, yet the ban was appealed and a stay was granted.142 as of february 2020, the centers for disease control and prevention (“cdc”) reported over 2,800 lung injury cases from 50 states and two united states territories, as well as several deaths, which additionally raises the issue of the impact of a comprised immune system and the coronavirus pandemic.143 140. eliminating youth electronic cigarette and other tobacco product use: the role for drug therapies; public hearing; request for comments, 83 fed. reg. 55,318 (nov. 5, 2018). 141. fda’s youth tobacco prevention plan, supra note 135; statement from fda commissioner scott gottlieb, m.d., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes, u.s. food & drug admin. (nov. 15, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissionerscott-gottlieb-md-proposed-new-steps-protect-youth-preventing-access [https://perma.cc/6khp9wgp]. fda, ftc take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies, supra note 139; statement from fda commissioner scott gottlieb, m.d., on new steps to address epidemic of youth e-cigarette use, supra note 136. see also sheila kaplan, purveyors of juice-box style, nicotine-filled e-liquids quit selling the products n.y. times (aug. 23, 2018), https://www.nytimes.com/2018/08/23/health/e-cigarettesmarketing.html [https://perma.cc/txx8-b8xv]. see also jennifer maloney & tom mcginty, fda seeks ban on menthol cigarettes, wall street j. (nov. 15, 2018, 1:18pm), https://www.wsj.com/ articles/big-tobacco-warns-it-may-fight-fda-over-a-menthol-ban-1542277800 [https://perma.cc/ ve5q-l6v7]. see also ned sharpless, how fda is regulating e-cigarettes, u.s. food & drug admin. (sept. 9, 2019), https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadershipand-experts/how-fda-regulating-e-cigarettes [https://perma.cc/x227-334d]. office of compliance and enforcement, office of health communication and education, office of regulations, & office of science in the center for tobacco products, guidance for industry, enforcement priorities for electronic nicotine delivery systems (ends) and other deemed products on the market without premarket authorization (2020), https://www.fda.gov/media/133880/download [https://perma.cc/7kuv-gfmb]. 142. vapor technology association v cuomo, no. 906514-19, 2020 ny slip op 20012 (n.y. app. div. jan. 8, 2020). see also jesse mckinely & christina goldbaum, n.y. approves emergency ban on flavored e-cigarettes (sept. 18, 2019), n.y. times https://www.nytimes.com/2019/09/ 15/nyregion/vaping-ban-ny.html [https://perma.cc/fz33-5s5d]. 143. see outbreak of lung injury associated with the use of e-cigarette, or vaping, products, ctrs. for disease control & prevention (oct. 3, 2019), https://www.cdc.gov/ tobacco/basic_ information /e-cigaret tes/severe-lung-disease.html#what-we-know [https://perma.cc/3rty-n94a]. around this same time period, president trump pronounced a ban on flavored on e-cigarettes including mint and menthol. sheila kaplan, trump administration plans to ban flavored e-cigarettes, n.y. times (sept. 19, 2019), https://www.nytimes.com/2019/09/11/ health/trump-vaping.html [https://perma.cc/2k8a-tu27]. subsequently, the fda issued a 2020] the family smoking prevention and tobacco control act 127 walmart stopped selling fruit-flavored e-cigarettes and raised the age to purchase tobacco products to twenty-one, which was prior to the legislation raising the minimum age to twenty-one to purchase tobacco and prior to the fda issued guidance document concerning flavored products.144 interestingly, juul®, who insists it did not market to teens, has pledged to restrict youth vaping, yet lobbyists in fifty states have vigorously objected to the proposed ban of flavors in e-cigarette pods popular with teenagers.145 juul®, the largest e-cigarette merchant, has focused on stricter online age verification, suspension of most flavors, and promotion to adults rather than to youth.146 further, the fda is concerned about menthol in cigarettes; however, suffice it to say that lengthy court challenges will follow if menthol is banned.147 the guidance policy directed toward refillable e-cigarette cartridges. see also sheila kaplan and matt richtel, the mysterious vaping illness that’s ‘becoming an epidemic’, n.y. times (aug. 31, 2019), https://www.nytimes.com/2019/08/31/health/vaping-marijuana-ecigarettes-sickness.html [https://perma.cc/5e9c-2wll]. 144. further consolidated appropriations act, pub. l. no 116-94, sec. 603, https://www.congress.gov/bill/116th-congress/house-bill/1865/text. this act was signed into law on december 20, 2019, amended section 906(d) of the federal food, drug, and cosmetic act to increase the federal minimum age to purchase tobacco products from 18 to 21, and added a provision that it is unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age. see also sarah nassauer, walmart to stop selling all e-cigarettes, wall street j. (mar. 5, 2020), https://www.wsj.com/articles/walmart-to-stop-selling-all-e-cigarettes-115690 03925 [https://perma.cc/8k94-kufc]. see jennifer maloney, juul debates pushing back on ecigarette ban, wall street j. (sept. 12, 2019, at 10:01pm), https://www.wsj.com/articles/ juuldebates-pushing-back-on-e-cigarette-ban-11568327978 [https://perma.cc/x7pj-44lt]. julie creswell & sheila kaplan, a ban on flavored e-cigarettes would sharply cut sales n.y. times (sept. 13, 2019), https://www.nytimes.com/2019/09/12/health/vaping-juul.html [https://perma.cc/ mc83-7yqg]. sheila kaplan, in washington, juul vows to curb youth vaping. its lobbying in states runs counter to that pledge., n.y. times (april 28, 2019), https://www.nytimes.com/ 2019/04/28/health/juul-lobbying-states-ecigarettes.html [https://perma.cc/98gl-strw] 145. see nassauer, supra note 144; cresswell & kaplan supra note 144; kaplan, supra note 144. yet see: sheila kaplan, juul bought ads appearing on cartoon network and other youth sites, suit claims, n.y. times, (feb. 12, 2020), https://www.nytimes.com/2020/02/12/health/juulvaping-lawsuit.html [https://perma.cc/53lf-elhc]. see also attorney general’s office lawsuit against juul, mass.gov, https://www.mass.gov/lists/attorney-generals-office-lawsuit-against-juul [https://perma.cc/xem4-z6b5]. 146. see sheila kaplan & jan hoffman, f.d.a. seeks restrictions on teens’ access to flavored e-cigarettes and a ban on menthol cigarettes, n.y. times (nov 15, 2018), h t tps:/ /www.nytimes.com/2018/1 1 /1 5 /h ea lth / ec iga re t t e s -fda -f lavors-ban .h tml [https://perma.cc/77h6-47ys]. see also sheila kaplan & jan hoffman, juul suspends selling most e-cigarette flavors in stores, n.y. times (nov. 13, 2018), https://www.nytimes.com/ 2018/11/13/health/juul-ecigarettes-vaping-teenagers.html [https://perma.cc/zl4r-tdq3] 147. regulation of flavors in tobacco products, 83 fed. reg. 122,94 (mar. 21, 2018) (data regarding use of menthol cigarettes and non-cigarette tobacco products among youth indicate 128 indiana health law review [vol. 17:107 european union’s ban on menthol cigarettes will commence in mid-2020,148 and interestingly, san francisco has already prohibited the sale of menthol cigarettes.149 canada has imposed a ban on menthol cigarettes as well.150 truly, this is a global issue. further, regarding menthol, e-cigarettes, and other ends, the evidence is far from convincing that menthol cigarettes, as well as ecigarettes, are not harmful.151 iv. illustrations of delay and harm to the public in contravention of the enumerated congressional findings of the tobacco control act tobacco use remains a leading cause of both premature, yet preventable, death in the united states according to the fda and the cdc.152 there are several specific areas where delay has been prevalent.153 first amendment concerns and the cost of human life, due to the deleterious effects of nicotine addiction, are apparently at a crossroad as illustrated by the marked delay in reissuing graphic warnings and the delay in issuing corrective statements discussed below.154 the question to examine is the cost of human life to the addictive effects of nicotine. a. fda’s legal authority to issue graphic and warning statements more than thirty years have passed since warnings were issued on cigarette widespread appeal of flavored tobacco products). maloney & mcginty, supra note 141 (detailing that according to a representative for rjr reynolds, who manufactures the newport brand, a legal battle will probably ensue). 148. directive 2014/40, of the european parliament and of the council of 3 april 2014 on the approximation of the laws, regulations and administrative provisions of the member states concerning the manufacture, presentation and sale of tobacco and related products and repealing directive 2001/37/ec, 2014 o.j. (l 127). see also corinne gretler, europe’s menthol ban has tobacco firms thinking outside the pack (feb. 5, 2020), https://www.bloomberg.com/ news/articles/2020-02-05/eu-menthol-ban-tobacco-firms-offer-alternatives-to-cigarettes [https://perma.cc/474p-ftph] (author details that imperial brands plc commenced selling cardboard (peppermint aroma) strips that can be inserted into a cigarette pack or pouch of rolling tobacco). 149. san francisco, cal. ordinance 140-17 (june 20, 2017). see also sheila kaplan, u. s. f.d.a. plans to seek a ban on menthol cigarettes, n.y. times, (nov. 9, 2018), https://www. nytimes.com/2018/11/09/health/fda-menthol-cigarettes-ban.html [https://perma.cc/xnz6-7u6z]. 150. order amending the schedule to the tobacco act (menthol), sor/2017-45 (can.). 151. see kaplan, supra note 144; maloney & mcginty, supra note 141. see also sheila kaplan, flashy science hub and vaping parties fail to win friends at w.h.o. tobacco talks, n.y. times (oct. 8, 2018), https://www.nytimes.com/2018/10/07/health/tobacco-e-cigarettestreaty.html [https://perma.cc/pz7r-3npj]. 152. smoking and tobacco use: diseases and death, supra note 3. 153. padon, maloney & cappella, supra note 120. 154. id. 2020] the family smoking prevention and tobacco control act 129 packaging and advertisements.155 to that end, the fsptca mandated that the fda develop regulations pertaining to warning statements and images to appear on cigarette packages and in cigarette advertisements.156 despite the issuance of the nine cigarette health warnings for all cigarette packaging and advertisements, legal challenges prevailed.157 scheduled to commence in september 2012, this issue became legally contentious due to the r. j. reynolds’ quest for an injunction, which the court granted and which led to the fda’s withdrawal of the proposed graphic warnings.158 yet, in discount tobacco city & lottery, inc, the court held that curbing juvenile tobacco use is a substantial government interest that is directly advanced by the fsptca’s provisions.159 further, discount tobacco held that graphic and textual warnings on cigarettes and smokeless tobacco products were reasonably related to the 155. laura bach, tobacco health warnings: evidence of effectiveness, https://www.tobaccofreekids.org/assets/factsheets/0325.pdf [https://perma.cc/75mq-rgg2]. 156. id. 157. r.j. reynolds tobacco co. et al. v. food & drug administration, 696 f.3d 1205 (d. c. cir. 2012). (on dec. 5, 2012, the court denied the government’s petition for panel rehearing and rehearing en banc. r.j. reynolds tobacco co. v. food & drug admin., no. 11-5332, 2012 u.s. app. lexis 24978 (d.c. cir. dec. 5, 2012); r.j. reynolds tobacco co. v. food & drug admin., no. 11-5332, 2012 u.s. app. lexis 24976 (d.c. cir. dec. 5, 2012)). the plaintiff tobacco companies alleged violation of their free speech rights under the first amendment. see r.j. reynolds tobacco co. et al. v. food & drug admin., 845 f. supp. 2d 266 (d.d.c. 2012). preliminary injunction granted november 7, 2011, which effectively stayed the new graphic warnings from fda implementation. r.j. reynolds tobacco co. et al. v. food & drug admin., 823 f. supp. 2d 36 (d.d.c. 2011). subsequently, the district court decided on february 29, 2012, that the government’s rule violated the tobacco companies’ rights to free speech and the fda filed an appeal. reynolds tobacco co. et al. v. food & drug admin., 845 f. supp. 2d 266 (d.d.c. 2012). (court of appeals for the district of columbia held that fda failed to provide substantial evidence that graphic warnings on cigarette advertising would advance the government’s interest in smoking reduction to a material degree r.j. reynolds tobacco co. et al. v. food & drug admin, food & drug admin., 696 f.3d 1205 (d.c. cir. 2012)). 158. r.j. reynolds tobacco co. et al. v. food & drug admin., 823 f. supp. 2d 36 (d.d.c. 2011). see also required warnings for cigarette packages and advertisements 76 fed. reg. 36,627 (june 22, 2011); see agency information collection activities; submission for office of management and budget review; comment review; experimental study of graphic cigarette warning labels 77 fed. reg. 72,355 (dec. 5, 2012); am. acad. of pediatrics, et al. v. u. s. food & drug administration, 330 f. supp. 3d 657 (d. mass. 2018); deeming tobacco products, supra note 16, at 29,032. american meat institute v. united states dept. of agriculture, 760 f.3d 18 (d.c. cir. 2014) rev’d r. j. reynolds on other grounds. the deeming rule uses the term that the r. j. reynolds decision was “overtaken” by the american meat institute decision. deeming tobacco products, supra note 16, at 28,989. 159. discount tobacco city & lottery, inc. 674 f.3d 509, 562 (2012). the united states supreme court denied cert., (case re-captioned). am. snuff co., llc v. united states 569 u.s. 946 (2013). 130 indiana health law review [vol. 17:107 government’s interest in preventing consumer deception and deemed them constitutional.160 the objectives of the warnings were to communicate the dangers of smoking and to decrease the number of people who smoke.161 the fda selected the final nine cigarette health warnings based on their ability to effectively communicate smoking health risks to the public.162 in creating the statements, the fda reviewed relevant scientific literature, more than 1,000 public comments, and results from its 18,000-person study.163 fda does have the legal authority to issue warnings.164 the tobacco control act provided the fda with the authority to regulate the labeling and advertising of cigarettes and, most importantly, directed that the fda issue color graphic warnings on cigarette packaging.165 the statute provides as follows: “[n]ot later than 24 months after the date of enactment of the family smoking prevention and tobacco control act, the secretary shall issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection (a)(1).”166 further, the deeming regulation issued in 2016 clarified that the fda still retains the legal authority to require warnings under the fsptca.167 in 2018, the court ordered the fda to issue long overdue revamped warnings on an expedited schedule since several years elapsed and fda did reissue textual warning and graphic images in 2020.168 hopefully, the reissued graphic warnings will pass constitutional muster without further delay, however a lawsuit by r.j. reynolds and other tobacco companies was filed in the federal district court eastern district texas regarding the reissued graphic warnings.169 160. discount tobacco city & lottery, inc. 674 f.3d at 564 (2012). 161. id. 162. r.j. reynolds tobacco co., 696 f.3d at 1209 (2012). 163. id. 164. 15 u.s.c. § 1333 (2018). 165. id. 166. id. 167. deeming tobacco products, supra note 16, at 29,026. 168. see tobacco products; required warnings for cigarette packages and advertisements 85 fed. reg. 15638 (march 18, 2020) (to be codified 21 cfr 1141). see also tobacco products; required warnings for cigarette packages and advertisements 84 fed. reg. 42754 (aug. 16, 2019). see also u.s. food & drug admin., required cigarette health warnings, 2020, https://www.fda.gov/media/136157/download [https://perma.cc/2srb-lyhd]. see lawsuit instituted by r.j. reynolds and other tobacco companies concerning the issuance of the graphic warnings, compl., r.j. reynolds tobacco company et al. v. u.s. food and drug administration et al., no 6:20-cv-00176 (dist. ct. e. d. tex., tyler div.). see also am. acad. of pediatrics, 330 f. supp. 3d. at 667 (2018). see also appendix c. 169. see id. (stating that the fda was ordered to submit to the court an expedited schedule); am. acad. of pediatrics v. united states fda, 2019 wl 1047149 (d. mass. mar. 5, 2019) (stating the proposed rule be submitted for publication in the federal register by august 15, 2019, and the final rule submitted for publication in the federal register by march 15, 2020). tobacco products; required warnings for cigarette packages and advertisements, 84 fed. reg. 42754 (aug. 16, 2020] the family smoking prevention and tobacco control act 131 b. manifest delay in the issuance of corrective statements another illustration of patent delay was the issuance of corrective statements in united states v. philip morris usa, inc., where the court ordered cigarette companies to issue corrective statements.170 undoubtedly, the wording of the corrective statements was significant; however, a ten-year delay is excessive. again, the issue is that of public health and the right-to-know. in a protracted court case, corrective statements were ordered,171 yet delay ensued, and the case against cigarette manufacturers and other tobacco entities spanned several years. in 2006, the district court determined that for years, decades, in fact, cigarette manufacturers were in violation under rico.172 further, the district court determined that for decades, the cigarette manufacturers had conspired to deny the health effects of smoking in violation of rico and ordered the cigarettes manufacturers to publish “corrective statements” to appear in newspapers, on television, on cigarette packages, and on websites specific to the health effects of smoking.173 the parties quarreled over the wording of these statements for a decade.174 eventually, the corrective statements were published in 2018.175 2019). https://www.federalregister.gov/documents/2019/08/16/2019-17481/tobacco-productsrequired-warnings-for-cigarette-packages-and-advertisements [https://perma.cc/8byz-2dfd]. compl., r.j. reynolds tobacco company et al. v. u.s. food and drug administration et al., no 6:20-cv-00176 (dist. ct. e. d. tex., tyler div.). 170. united states v. philip morris usa inc., 855 f.3d 321, 328-28 (d.c. cir. 2017). 171. id. 172. see generally united states v. philip morris usa, inc., 449 f. supp. 2d 1 (d.d.c. 2006). see also philip morris usa inc., 855 f.3d. at 323 (“in 2006, the district court found that appellant cigarette manufacturers had for decades conspired to deny the health effects of smoking in violation of rico . . . the court ordered appellants to disseminate “corrective statements” relating to the health effects of smoking in newspapers, on television, on cigarette packages, and on websites. for more than a decade since, the parties have battled over the precise language of these statements. appellants claim the most recent language proposed by the government is conduct-focused and is backward-looking beyond the scope of rico and . . . violates the first amendment.”) (citations omitted). the term rico is commonly used to denote the racketeer influenced and corrupt organizations act. rico charges, dep’t of just., https://www.justice.gov/jm/criminal-resourcemanual-109-rico-charges [https://perma.cc/5t6w-c7ea]. 173. see generally philip morris usa, inc., 449 f. supp. 2d 1 (2006). 174. philip morris usa inc., 855 f.3d. at 323 (2006). 175. second superseding order implementing the corrective statements remedy for newspapers and television, united states v. philip morris, no. 99-cv-2496 (d.d.c. oct. 5, 2017), https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?1999cv2496-6227[https://perma.cc/k8ykwful]. corrective statements: ads and social media, campaign for tobacco-free kids, https://www.tobaccofreekids.org/media/2017/corrective-statements [https://perma.cc/q5ytar5v]; text of court-ordered corrective statements: united states v. philip morris usa inc, campaign for tobacco-free kids, https://www.tobaccofreekids.org/assets/content/what_we_do/ 132 indiana health law review [vol. 17:107 v. viable recommendations to protect the public health although the fda is restricted at times to a reactionary role in regulating tobacco products, the agency does have methods to regulate such as warning letters, civil money penalty (cmp) complaints, no-tobacco-sale order (ntso) complaints, seizures, injunctions, and criminal prosecution.176 the question remains as to the lengthy timeframe involved in such measures. as illustrated by the graphic warnings proceedings, several years elapsed and still, the reissued warnings are questionable in terms of potential challenges by stakeholders such as tobacco conglomerates.177 undoubtedly, the tobacco industry could again hamper fda efforts and public protection with protracted court battles. further, lobbying has played a significant role in the tobacco products regulation.178 today, the power of the tobacco industry’s lobbying campaigns continues to be a major obstacle in preventing the implementation of increased regulation.179 while most major industries have lobbying efforts, the tobacco industry stands out from the rest, spending a colossal amount of money annually.180 admittedly, there is no perfect solution to these delays. understandably, advocacy on behalf of the client is critical. yet the extensive delay involved in finally issuing the corrective statements appears well beyond that of zealous advocacy. the fda’s delay in reissuing graphic warning statements was equally as troubling. perhaps the fda’s reluctance to reissue new warnings was due in part to another perceived looming first amendment challenge. finally, the fsptca and deeming regulations that include e-cigarettes and other ends have industry_watch /doj/cor rec t ive_ s t a t em en ts/2017_10_corrective_statements.pdf [https://perma.cc/p6g2-vq65]. 176. compliance, enforcement & training, u.s. food & drug admin., https://www.fda.gov/ tobaccoproducts/guidancecomplianceregulatoryinformation/default.htm [https://perma.cc/zq2v8dqh]. 177. see am. acad. of pediatrics 330 f. supp. 3d at 662 (2018). tobacco products; required warnings for cigarette packages and advertisements, 84 fed. reg. 42754 (aug. 16, 2019). https://www.federalregister.gov/documents/2019/08/16/2019-17481/tobacco-products-requiredwarnings-for-cigarette-packages-and-advertisements [https://perma.cc/8byz-2dfd]. see also supra note 168. 178. ash, denial, deceit and delay — tobacco industry lobbying tactics, medium (may 2, 2017), https://medium.com/@ash_ldn/denial-deceit-and-delay-tobacco-industry-lobbyingtactics-c5aee7ff4bbc [https://perma.cc/43e8-zqqu]. 179. see e. g., eric lipton, a lobbyist wrote the bill. will the tobacco industry win its ecigarette fight?, n.y. times (sept. 2, 2016), https://www.nytimes.com/2016/09/03/us/politics/ecigarettes-vaping-cigars-fda-altria.html [https://perma.cc/3ev3-yamt]; tobacco war lobbying documents, n.y. times (sept. 2, 2016), https://www.nytimes.com/interactive/2016/08/26/us/ politics/document-tobacco-lobbying-documents.html [https://perma.cc/q3k8-337e] (hosting documents illustrating efforts to thwart deeming rule). 180. id. see also tobacco, opensecrets, https://www.opensecrets.org/industries/indus.php? ind=a02 [https://perma.cc/c3pv-247n]. 2020] the family smoking prevention and tobacco control act 133 taken the forefront in the “tobacco war.”181 just as it is incumbent for the fda to take concrete action as it has recently done with the epidemic of youth e-cigarette use and other ends products, the tobacco industry needs to step up as well. the reality is that the fda clearly does not have the legal authority to ban tobacco, yet the fda has the legal authority to regulate it.182 traditional rulemaking will only delay, for example, any menthol ban and delay any prohibition of youth use of e-cigarettes and other end systems. perhaps the fda, the cdc, and other relevant federal agencies and industry stakeholders, should aim to resolve issues through informal rulemaking. a. lessons from other fda centers—guidance documents and declaratory orders 1. guidance documents the fda could issue a series of guidance documents with the recognition that guidance documents are not legally binding, and in fact did so in 2020.183 an 181. notably in 2018, former fda commissioner scott gottlieb, m. d. announced policies aimed toward curbing youth smoking. see, e.g., scott gottlieb& mitch zeller, advancing tobacco regulation to protect children and families: updates and new initiatives from the fda on the anniversary of the tobacco control act and fda’s comprehensive plan for nicotine, u.s. food & drug admin. (aug. 2, 2018), https://www.fda.gov/newsevents/newsroom/fdavoices/ ucm619118.htm [https://perma.cc/5j8w-utng]. 182. see 21 u.s.c. § 387g (2018) (“ (3) limitation on power granted to the food and drug administration.—because of the importance of a decision of the secretary to issue a regulation—(a) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or (b) requiring the reduction of nicotine yields of a tobacco product to zero, the secretary is prohibited from taking such actions under this act”.) 183. see generally guidances, u.s. food & drug admin., https://www.fda.gov/ forindustry/fdabasicsforindustry/ucm234622.htm [https://perma.cc/5zwl-6me3]. see u.s. food & drug admin, enforcement priorities for electronic nicotine delivery systems and other deemed products on the market without premarket authorization; guidance for industry (2020), https://www.fda.gov/media/133880/download [https://perma.cc/ug8g86r7]. the enforcement priorities for electronic nicotine delivery systems (ends) and other deemed products on the market without premarket authorization guidance prohibiting most flavors (including mint) except menthol and tobacco in cartridge-based e-cigarettes; however, the ban is inapplicable to tank vaping systems. according to the guidance policy the definition of ends in the guidance document does not include disposable products; see also executive order 13891 84 fed. reg. 55,235 (oct. 9, 2019). it is tilted: promoting the rule of law through improved agency guidance documents and was issued in 2019. the overall purpose is that of uniformity similar to the discussion below and focuses on increased accountability in terms of a 30day minimum notice and comment period prior to issuing the guidance as well as providing notice to the public of the issuance of the guidance document. 134 indiana health law review [vol. 17:107 example of stakeholder and fda collaboration that could transcend to tobacco products regulation is that of the agency’s center of veterinary medicine which handles antimicrobial resistance and residues.184 the fda is responsible for ensuring that animal drugs and medicated feeds are not only safe and effective for animals but also that food products from treated animals are safe for humans to consume.185 over the years, the fda responded to concerns about antimicrobial resistance and drug residues.186 the national antimicrobial resistance monitoring system (“narms”) coordinated with the united states department of agriculture and the cdc.187 the fda issued several guidance documents throughout the years.188 although the fda actively tackled the issue of antimicrobial resistance since 1996, it was not until late 2013 when the fda issued guidance for industry (gfi) #213 that outlined more proactive steps.189 the guidance detailed a phase-out of antimicrobial drugs in animals used for food 184. see generally fda releases annual summary report on antimicrobials sold or distributed in 2017 for use in food-producing animals showing declines for past two years, u.s. food & drug admin., https://www.fda.gov/animalveterinary/newsevents/cvmupdates/ ucm628504.htm [https://perma.cc/r7bu-gpew]. see also antimicrobial resistance, u.s. food & drug admin., https://www.fda.gov/animalveterinary/safetyhealth/antimicrobialresistance/ default.htm [https://perma.cc/5lgm-dmre]. 185. fda fifth biannual progress report on judicious use of antimicrobials in foodproducing animals, u.s. food & drug admin., https://wayback.archive-it.org/7993/20190208 023234/https://www.fda.gov/animalveterinary/newsevents/cvmupdates/ucm509403.htm (archived copy feb. 8, 2019). besides the fda, the center for disease control is involved with safety issues concerning food-producing animals. see, e.g., antibiotic resistance, food, and foodproducing animals, ctrs. for disease control & prevention, https://www.cdc.gov/features/ antibiotic-resistance-food/index.html [https://perma.cc/87pr-6hu7]. 186. antimicrobial resistance, supra note 184. 187. the national antimicrobial resistance monitoring system, u.s. food & drug admin., https://www.fda.gov/animalveterinary/safetyhealth/antimicrobialresistance/nationalantimicrobia lresistancemonitoringsystem/default.htm [https://perma.cc/dnr6-fcrp]. 188. see generally u.s. food & drug admin, final guidance for industry studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological adi vich gl-36 and a guidance titled: final guidance for industry studies to evaluate the safety of residues of veterinary drugs in human food: general approach to testing vich gl33 (2009), https://www.fda.gov/ media/75205/download [https://perma.cc/d3el-l4zm]. this final guidance replaced a 2006 guidance and outlined a testing approach to assure human food safety following the consumption of food products derived from animals treated with veterinary drugs. the guidance combines developmental toxicity testing proposals of the european union, japan, and the united states for the safety of veterinary drug residues in human food. 189. u.s. food & drug admin., new animal drugs and new animal drug combination products administered in or on medicated feed or drinking water of food-producing animals: recommendations for drug sponsors for voluntarily aligning product use conditions with gfi #209 (2013), https://www.fda.gov/media/ 83488/download [https://perma.cc/7z9g-34vu]. 2020] the family smoking prevention and tobacco control act 135 production.190 according to the fda, the agency issued voluntary guidance promoting the judicious use of antibiotics in food animal production as preferable due to resource limitations; that is, according to the fda, the agency would use fewer resources compared to withdrawing the animal drugs on an individual basis.191 in so doing, the fda used a collaborative methodology involving stakeholders such as animal pharmaceutical companies.192 2. declarative order under the administrative procedures act perhaps the fda should consider utilizing section 554(e) of the administrative procedures act (apa) and issue a declarative order regarding menthol and any further action regarding e-cigarettes.193 for example, the fda issued a milestone determination in 2015, stating that partially hydrogenated oils (phos) are not “generally recognized as safe (gras) for use in any food.”194 a “declaratory order”, which has the “force and effect” of a rule, was issued pursuant to 5 u.s.c. 554(e) of the apa.195 there was a phase-out program regarding the use of these oils in the food supply and removal from the united states food supply.196 the federal register notice concerning hydrogenated fat 190. id. 191. interestingly, the fda had denied petitions to ban medically important antibiotics used in animals. however, the district court in natural resources defense council, inc. v. united states fda ordered the fda to reconsider the denied petitions. 872 f. supp. 2d 318, 342 (s.d.n.y. 2012). the court of appeals reversed the district court’s determination that the fda was required by “21 u.s.c. § 360b(e)(1) to proceed with hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed and that the fda’s decision denying two citizen petitions urging it to hold such hearings was arbitrary or capricious within the meaning of 5 u.s.c. § 706(2).” nrdc, inc. v. united states fda, 760 f.3d 151, 153 (2nd cir. 2014). specifically, the court of appeals concluded that the “decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary determination left to the prudent choice of the fda.” id. at 175. the appeals court agreed with the fda’s determination that its “preferred program of voluntary compliance offers greater prospect for immediate and significant reductions in animal antibiotic use than the pursuit of a potentially contentious withdrawal hearing.” id. further, the court of appeals opined that they could not conclude that it is “arbitrary or capricious” for the fda to follow policies intended to reduce the use of animal feed containing antibiotics through various phases “short of withdrawing approval for the use of antibiotics in feed via a protracted administrative process and likely litigation.” id. 192. see generally termini, supra note 1. 193. see generally 5 u.s.c. § 554(e) (2018). 194. final determination regarding partially hydrogenated oils, 80 fed. reg. 34,650 (june 17, 2015). phos are the primary dietary source of artificial trans fat in processed foods. 195. 5 u.s.c. 554(e) (2018). 196. final determination regarding partially hydrogenated oils, 83 fed. reg. 23,358 (may 21, 2018). 136 indiana health law review [vol. 17:107 was published on november 8, 2013.197 the fda received 6,000 comments and 4,500 letters in response to the november 2013 notice about the fda tentative determination regarding gras elimination.198 the fda found “that there is no longer a consensus among qualified experts that partially hydrogenated oils (phos), which are the primary dietary source of industrially-produced trans fatty acids (ip–tfa) are generally recognized as safe (gras) for any use in human food.”199 the fda order specific to the pho ban means that food manufacturers would no longer be permitted to sell phos, either directly or as ingredients in another food product, without prior fda approval for use as a food additive.200 the order permitted a three-year phase-out period for reformulation and product relabeling, with compliance required by june 18, 2018, and in some situations by january 1, 2020.201 could the same, in terms of a declaratory order under the apa, be accomplished for a menthol ban and curtailing the e-cigarette epidemic by youth? vi: final insight for the reader the question remains—at what cost to human life? the fda, the cdc, industry stakeholders, health care, and consumer interest stakeholders need to solve these critical issues in the most expedient manner. in so doing, this imparts designing realistic solutions to curb, for instance, the discernable upsurge of youth e-cigarette use. continued delay tactics harm the health of the united states population and most significantly, our youth. 197. tentative determination regarding partially hydrogenated oils; request for comments and for scientific data and information, 78 fed. reg. 67,169 (nov. 8, 2013). the comment period was extended until march 8, 2014. tentative determination regarding partially hydrogenated oils; request for comments and for scientific data and information; extension of comment period 78 fed. reg. 79,701 (dec. 31, 2013). 198. final determination regarding partially hydrogenated oils, 80 fed. reg. 34,650, 34,651 (june 17, 2015). 199. id. at 34,650. 200. id. at 34,652-53. 201. tentative determination regarding partially hydrogenated oils; request for comments and for scientific data and information, 78 fed. reg. 67,169 (nov. 8, 2013). 2020] the family smoking prevention and tobacco control act 137 appendix a: diversity of e-cigarette products202 figure 1.1 e-cigarettes include a diverse group of devices that allow users to inhale an aerosol, which typically contains nicotine, flavorings, and other additives. ecigarettes vary widely in design and appearance, but generally operate in a similar manner and are composed of similar components (figure 1.1). a key challenge for surveillance of the products and understanding their patterns of use is the diverse and nonstandard nomenclature for the devices (alexander et al. 2016). these devices are referred to, by the companies themselves, and by consumers, as “e-cigarettes,” “e-cigs,” “cigalikes,” “e-hookahs,” “mods,” “vape pens,” “vapes,” and “tank systems.” in this report, the term “e-cigarette” is used to represent all of the various products in this rapidly diversifying product category. the terms may differ by geographic region or simply by the prevailing preferences among young users. for example, some refer to all cigarette-shaped products as “e-cigarettes” or as “cigalikes,” and some may refer to the pen-style e-cigarettes as “hookah pens” or “vape pens” (richtel 2014; lempert et al. 2016). source: photo by mandie mills, cdc at 3. 202. u.s. dep’t of health and human serv, e-cigarette use among youth and young adults: a report of the surgeon general 3 (2016), https://e-cigarettes. surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf [https://perma.cc/bfg8mnec] 138 indiana health law review [vol. 17:107 appendix b: the tariff classification of a nicotine inhaler and parts from china203 ny m85579 august 22, 2006 cla-2-85:rr:nc:n1:112 m85579 category: classification tariff no.: 8543.89.9795; 3824.90.2800 mark weiss weiss & moy, p.c. 4204 n. brown avenue scottsdale, az 85251-3914 re: the tariff classification of a nicotine inhaler and parts from china dear mr. weiss, in your letter dated july 20, 2006, you requested a tariff classification ruling. the items concerned are the ruyan electronic cigarette and the ruyan electronic cigarette cartridge. the cigarette is a spherical, metal tube with a plastic mouthpiece tip on the end which measures approximately 5 ½” in length. inside the tube are a sensor, electronic atomizer, integrated circuits and a lithiumion battery. the spherical cartridge is attached to a plastic mouthpiece tip and contains nicotine and propylene glycol. the purpose of the ruyan electronic cigarette is to act as a nicotine inhaler that has atomized smoke being forced out of the plastic mouthpiece tip. you state that the these items will be marketed in five, different packages: 1. electronic cigarette with two rechargeable 3.7-volt batteries 2. electronic cigarette with two rechargeable 3.7-volt batteries and five cartridges 3. five cartridges, ten cartridges and twenty cartridges the applicable classification subheading for the ruyan electronic cigarette with batteries and the ruyan electronic cigarette with batteries and cartridges will be 203. the tariff classification of a nicotine inhaler and parts from china, ny m85579 (2006), h t t p s : / / r u l i n g s . c b p . g o v / s e a r c h ? t e r m = m 8 5 5 7 9 & c o l l e c t i o n = al l & s o r t b y= relevance&pagesize=30&page=1 [https://perma.cc/87rh-cjbv]. 2020] the family smoking prevention and tobacco control act 139 8543.89.9795, harmonized tariff schedule of the united states (htsus), which provides for “electrical . . . apparatus, having individual functions, not specified or included elsewhere . . . : other . . . apparatus: other: other: other: other: other”. the rate of duty will be 2.6%. the applicable classification subheading for the packages of five cartridges, ten cartridges and twenty cartridges will be 3824.90.2800, harmonized tariff schedule of the united states (htsus), which provides for “. . . preparations of the chemical or allied industries . . . , not elsewhere specified or included: other: other: mixtures containing 5 percent or more by weight of one or more aromatic or modified aromatic substances: other”. the rate of duty will be 6.5%. duty rates are provided for your convenience and are subject to change. the text of the most recent hts and the accompanying duty rates are provided on world wide web at http://www.usitc.gov/tata/hts/. this ruling is being issued under the provisions of part 177 of the customs regulations (19 c.f.r. 177). a copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. if you have any questions regarding the ruyan electronic cigarette, contact national import specialist richard laman at 646-733-3017. if you have any questions regarding the ruyan electronic cigarette cartridge, contact national import specialist richard dunkel at 646-733-3032. 140 indiana health law review [vol. 17:107 appendix c: required health warnings204 the family smoking prevention and tobacco control act (tca) granted fda important new authority to regulate the manufacture, marketing, and distribution of tobacco products. the tca also amended section 4 of the federal cigarette labeling and advertising act (fclaa), directing fda to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. the tca amends the fclaa to require each cigarette package and advertisement to bear one of the new required warnings. in march 2020, fda finalized the “required warnings for cigarette packages and advertisements” rule, establishing 11 new cigarette health warnings, consisting of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. these new required warnings depict some of the lesser-known, but serious health risks of smoking. 204. cigarette labeling and health warning requirements, u.s. food & drug admin., https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobaccoproducts/cigarette-labeling-and-health-warning-requirements [https://perma.cc/3nrf-hrk5]. see also u.s. food & drug admin., required cigarette health warnings, 2020, https://www. fda.gov/media/136157/download [https://perma.cc/2srb-lyhd]. see also lawsuit instituted by r.j. reynolds and other tobacco companies concerning the issuance of the graphic warnings, compl., r.j. reynolds tobacco company et al. v. u.s. food and drug administration et al., no 6:20-cv-00176 (dist. ct. e. d. tex., tyler div.). 2020] the family smoking prevention and tobacco control act 141 142 indiana health law review [vol. 17:107 2020] the family smoking prevention and tobacco control act 143 144 indiana health law review [vol. 17:107 2020] the family smoking prevention and tobacco control act 145 146 indiana health law review [vol. 17:107 2020] the family smoking prevention and tobacco control act 147 148 indiana health law review [vol. 17:107 2020] the family smoking prevention and tobacco control act 149 150 indiana health law review [vol. 17:107 2020] the family smoking prevention and tobacco control act 151 localism and the opioid crisis: overcoming state and federal hurdles to cityand county-run supervised injection facilities and syringe exchange programs in indiana sam thompson* i. introduction “[i]t is far less burdensome on both the courts and the [l]egislature for the law to presume the existence of local authority to act absent some express prohibition, than it is to require legislation spelling out every detail of every permissible action a municipality may take.”1 historically, public health in the united states was a fundamentally local concern.2 in the eighteenth century, american cities enacted rules for trade-ship quarantine and the isolation of sick populations.3 in the nineteenth century, it was cities that reacted to increased urbanization by establishing rules for sanitation.4 in the late twentieth century, local innovation in public health “flourished” with such measures as smoking bans.5 it is unsurprising then, in the wake of the opioid crisis, it is american cities and counties that are ground zero for innovation.6 at present, the opioid crisis is one of the most pressing concerns on a state, local, and national level: in 2017, the then-acting department of health and human services (“hhs”) secretary, eric hargan, declared the opioid epidemic a “nationwide public health emergency.”7 months later, officials in eight states * j.d. candidate, 2021, indiana university robert h. mckinney school of law; b.a., 2009, indiana university kokomo, kokomo, indiana. in memory of my best friend and brother luke, who would have found it hilarious that he was mentioned here; with a special thanks to professor nicolas terry for his invaluable expertise and guidance. 1. kole v. faultless, 963 n.e.2d 493, 498 (ind. 2012). 2. daniel goldberg, nimbyism continues to factor into supervised injection site policies, harv. u. sch. l. (june 28, 2018), http://blog.petrieflom.law.harvard.edu/2018/06/28/nimbyismcontinues-to-factor-into-supervised-injection-site-policies/ [https://perma.cc/pn2t-s2fm]. 3. comm. for the study of the future of pub. health, inst. of med., the future of public health 57 (1988). 4. id. at 58. 5. scott burris et al., federalism, policy learning, and local innovation in public health: the case of the supervised injection facility, 53 st. louis u. l.j. 1089, 1108 (2009). 6. see generally george washington univ. milken sch. of pub. health, opioid use disorder: city actions and opportunities to address the epidemic 1 (2018), https://www. nlc.org/sites/default/files/users/user75/nlc_opiods_bckgrndr_final_032618_r2.pdf [https://perma.cc/bl2y-bpcr]. 7. press release, sec’y eric d. hargan, u.s. dep’t of health & human servs., hhs acting secretary declares public health emergency to address national opioid crisis (oct. 26, 2017), https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-healthemergency-address-national-opioid-crisis.html [https://perma.cc/nz94-peu6]. 442 indiana health law review [vol. 18:441 similarly declared such an emergency.8 at the local level, cities and counties across the united states are reacting in their own uniquely local ways.9 but, local governments10 are in a precarious position to deal with opioid use disorder (“oud”). facing opposition from state and federal officials, local governments must tread lightly and work collaboratively in order to implement successful solutions to the problem.11 this opposition is borne out by the numbers: as of 2018, fifteen states prohibited syringe exchange programs (“seps”).12 of course, there has been a sea-change in seps’ acceptance by state and federal governments. in fact, indiana played a central role in seps’ acceptance on a federal level: it was not until indiana’s hiv outbreak in 2015 that lawmakers removed a ban on federally funded seps.13 even so, indiana localities continue to face challenges – as recent as the just-adjourned general assembly session – from state lawmakers concerning local health-and-safety regulations.14 this does not mean, however, that cities are hamstrung to the whim of the state for “pretty much everything except to brush [their] teeth in the morning.”15 in this note, i argue that local governments in indiana have broad leeway to work within state statutory boundaries and that enabling seps and supervised injection facilities (“sifs”) may be well within those boundaries.16 indiana has given local governments legislative authority to act within a 8. astho staff, emergency declarations in eight states to address the opioid epidemic, ass’n st. & territorial health org. (jan. 11, 2018), https://www.astho.org/statepublichealth/ emergency-declarations-in-eight-states-to-address-the-opioid-epidemic/01-11-18/ [https://perma.cc/cgp5-dt2t]. 9. see generally george washington univ. milken sch. of pub. health, supra note 6. 10. consistent with indiana law, the term “local government,” as used in this note, refers to a county, municipality, or township government. see ind. code § 36-1-2-23 (2021). 11. see infra section iv-b (noting federal and state opposition to sifs). 12. german lopez, needle exchanges have been proved to work against opioid addiction. they’re banned in 15 states, vox (june 22, 2018), https://www.vox.com/science-and-health/2018/ 6/22/17493030/needle-exchanges-ban-state-map [https://perma.cc/8nwn-scbw]. 13. john stanton, after decades, congress effectively lifts ban on federally funded needle exchanges, buzzfeed (jan. 5, 2016), http://www.buzzfeed.com/johnstanton/after-decadescongress-effectively-lifts-ban-on-federally-fu#.yelagdjxvq [https://perma.cc/z8zk-j89d]. 14. see, e.g., s.b. 207, 121st gen. assemb., 1st reg. sess. (ind. 2020). 15. henry grabar, the shackling of the american city, slate (sept. 9, 2016), https://slate. com/business/2016/09/how-alec-acce-and-pre-emptions-laws-are-gutting-the-powers-of-americancities.html [https://perma.cc/nrd8-h78j] (quoting jay fisette, former chairman of the arlington county board in virginia, and generally comparing a state's power to preempt local law to a "straitjacket"). 16. see scott burris et al., the legal strategies used in operating syringe exchange programs in the united states, 86 am. j. pub. health 1161 (1996) (discussing local seps as “successfully operating” without express state or federal authority) [hereinafter the legal strategies used in operating syringe exchange programs in the united states]. 2021] localism and the opioid crisis 443 sphere of local concern via the home rule act of 1980 (“home rule act”).17 the current body of indiana case law delineates the home rule act as it pertains mostly to local government organizations, zoning, and, to some extent, natural resources.18 notably, the indiana supreme court has not addressed in what way the home rule act would interact with health-and-safety regulations. in order to be given effect and contour, the home rule act must be, to borrow indiana supreme court chief justice loretta rush’s exhortation, “appreciated, invoked, and properly applied.”19 indeed, local health-and-safety concerns are currently a pertinent area of contention and concern where a little bit of proper application could yield clarity and solutions to issues regarding state and local conflict. this is not to say that indiana cities do not face an incredibly rocky path in considering sifs and seps; they do. more than a few commentators argue that home rule authority is not a significant source of autonomy.20 it has also been asserted that a locally authorized sif would be on the “weakest footing” compared to a state-sanctioned facility.21 further, home rule authority seems to run contrary to the indiana supreme court’s jurisprudence.22 still, indiana’s current home rule jurisprudence is silent on the issue of the local government’s ability to enact health-and-safety measures under home rule authority. in order to properly delineate the boundaries of the home rule act, it must be invoked. the opioid crisis and relevant current litigation provide an opportunity for cities and counties to cautiously weigh their options, engage in diligent research, and develop case law by meeting the challenges that they will undoubtedly face. and, though it is not a magic bullet, indiana’s home rule act offers a tool for local governments to try to meet these challenges. ii. scope of article and arguments while there has been a fair amount of action in combatting oud, there are 17. ind. code § 36-1-3-4(b) (2021) (granting local governments “all . . . powers necessary or desirable in the conduct of [their] affairs, even though not granted by statute”). 18. see, e.g., kole v. faultless, 963 n.e.2d 493 (ind. 2012) (addressing the organization of local government); city of crown point v. lake county, 510 n.e.2d 684 (ind. 1987) (addressing zoning regulation); town of avon v. west central conservancy dist., 957 n.e.2d 598 (ind. 2011) (addressing the regulation of water use). 19. cf. loretta h. rush & marie forney miller, a constellation of constitutions: discovering & embracing state constitutions as guardians of civil liberties, 82 alb. l. rev. 1353, 1384 (2019) (commenting on state litigants’ failure to assert indiana constitutional claims). 20. see, e.g., jesse j. richardson, dillon’s rule is from mars, home rule is from venus: local government autonomy and the rules of statutory construction, 41 publius 662 (2011) (describing home rule as not truly endowing municipalities with any meaningful autonomy). 21. leo beletsky et al., the law (and politics) of safe injection facilities in the united states, 98 am. j. pub. health 231, 233 (2008) (noting city attempts to authorize sifs being successfully challenged under state law). 22. see hunter v. city of pittsburg, 207 u.s. 161, 178 (1907) (establishing state sovereignty over municipalities). 444 indiana health law review [vol. 18:441 fundamental differences in interests between the state and local levels. these differences present a compelling case for the need for local action. two of the safest and most effective solutions are sifs and seps. in this note, i argue that local government in indiana is well-positioned to implement such facilities by way of its home rule act. after situating indiana and its cities and counties in the opioid crisis, i present a brief overview of the efficacy of seps and sifs and how local governments in indiana might implement such measures. i explore how the home rule act might interact with state drug and health law, demonstrating that there are at least tenable arguments to be made in support of a local government-run sif or sep. separately, i also explore how local government might respond to the common objections made by the united states government when attempting to enjoin such facilities from opening. this note is not, however, a litigation road map. the case of safehouse v. united states – where the united states government challenged an attempted philadelphia sif – is currently being briefed at the third circuit, and the parties’ briefs are an excellent source of data and legal arguments.23 nor do i purport to do a deep dive into some of the more labyrinthine preemption doctrines or even attempt how to address the common nimby objections. such is beyond the scope of this note. the thrust of this note is this: indiana’s home rule act remains all but unlitigated in the realm of health-and-safety regulations and is a potential source of meaningful authority. in order to properly understand and develop the boundaries through courts’ understanding of the law, the home rule act must be invoked as a source of authority for local action. this note provides an overview of what this invocation could look like in the realm of combatting the opioid crisis. iii. opioid use disorder presents a pressing and ongoing problem for indiana in indiana, the state’s position on oud does not look markedly different from that of the federal government. on his first day in office, indiana governor eric holcomb issued a statement agreeing with hhs’s assessment, calling for an “all hands on deck” approach and creating the state’s first drug czar.24 governor holcomb subsequently signed into law several new acts addressing the crisis.25 so far, the effects seem promising: preliminary numbers from the indiana university public policy institute and the indiana state department of health 23. see, e.g., brief for cato inst. et al. as amici curiae in support of appellees, united states. v. safehouse, 985 f.3d 225 (3d cir. 2021) (no. 20-1422), 2020 wl 3833360. 24. next level recovery ind., progress report 2 (2020), https://www.in.gov/recovery/ files/progress%20report%20-%2011.12.2020.pdf [https://perma.cc/2sw9-wa2b]. 25. id. 2021] localism and the opioid crisis 445 indicate a decline in overdose deaths in indiana cities in 2018.26 but according to the richard m. fairbanks foundation, in 2018, the federal funding that indiana received to combat the opioid crisis was likely less than the total for which the state would have been eligible if the number of opioid-involved deaths had not been seriously undercounted.27 indeed, the continued economic detriment to the state reflects the foundation’s findings; researchers at indiana university predicted that indiana’s economic damages due to the opioid crisis for the year 2018 would exceed $4 billion.28 certainly, lower casualties are progress. but not all is well. through an assessment by the centers for disease control and prevention, indiana did not see a significant change in heroin-involved deaths between 2017 and 2018.29 this, coupled with the severe economic injury to the state, counsels in favor of an urgent fix. as the executive director of washington’s people’s harm reduction alliance puts it, even “one is too many.”30 while state efforts are promising, cities and counties are better positioned to address issues related to oud. 26. compare leslie wells, chjr researchers examine drug overdose deaths in marion county, o’neill sch. iupui (july 22, 2019), https://blog.oneill.iupui.edu/2019/07/22/2018overdose-deaths/ [https://perma.cc/na8t-cmqq] (reporting a decrease in the number of opioidrelated overdose deaths in marion county, from 329 in 2017 to 286 in 2019), and lincoln wright, overdose deaths down in 2018 after record high previous year, s. bend trib. (mar. 17, 2019), https://www.southbendtribune.com/news/publicsafety/overdose-deaths-down-in-after-record-highprevious-year/article_6ffaeaad-552f-573f-8920-486aa9ea6a8f.html [https://perma.cc/3q6n-hwh6] (reporting a decrease in opioid-related overdose deaths in st. joseph county from sixty-one in 2017 to forty-one in 2018), with opioid overdose: 2017 drug overdose death rates, ctr. for disease control & prevention (mar. 17, 2020), https://www.cdc.gov/drugoverdose/data/statedeaths/ drug-overdose-death-2017.html [https://perma.cc/le6w-6vdh] (showing an increase in opioidrelated overdose deaths from 2016 to 2017, giving indiana the third-highest overdose rate increase in the nation). 27. alex cohen, how does indiana’s federal opioid funding compare to its opioidinvolved overdose deaths?, richard m. fairbanks found. (apr. 10, 2019), https://www.rmff. org/how-does-indianas-federal-opioid-funding-compare-to-its-opioid-involved-overdose-deaths/ [https://perma.cc/z5z8-puv5]. 28. ryan m. brewer & kayla m. freeman, cumulative economic damages from 15 years of opioid misuse throughout indiana, 93 ind. bus. rev. art 1 (2018), http://www.ibrc.indiana.edu/ ibr/2018/spring/article1.html [https://perma.cc/w7hd-l6lv]. 29. heroin overdose data, ctr. for disease control & prevention, https://www.cdc. gov/drugoverdose/data/heroin.html [https://perma.cc/65ru-8tf4] (last updated mar. 19, 2020). 30. nadia romero, king county overdose deaths rise, but no agreement on how to deal with opioid crisis, q13 fox (may 9, 2018), https://q13fox.com/2018/05/09/still-no-agreement-onhow-to-deal-with-opioid-crisis-while-king-county-overdose-deaths-rise/ [https://perma.cc/d3taywbg]. 446 indiana health law review [vol. 18:441 a. indiana’s cities and counties are uniquely positioned to address the problem local officials are closest to the communities that they serve and, thus, are uniquely positioned to respond to the issues affecting those communities.31 in fact, many local governments across the united states are already implementing solutions to combat oud with innovations like establishing opioid-intervention courts and working across sectors to provide resources like housing and mental health support.32 further, despite combatting oud being one of the “top priorities” of hhs,33 city and county leaders across the united states recognize that local needs do not always mirror the goals of the federal government – especially in responding to a drug crisis.34 this same incongruity of interest can be seen between the state and local level in indiana: indiana attorney general curtis hill has equated harm reduction efforts – such as seps – with an increase in harm.35 meanwhile, some localities, such as marion county, have expressly approved of and adopted such measures.36 attorney general hill recognizes that seps, such as the one in scott county, indiana, have been successful in the slowing of the spread of disease.37 yet, despite evidence to the contrary, attorney general hill claims that distributing clean syringes can lead to increased drug usage.38 in what he describes as “the dangers of eroding personal accountability,” attorney general hill warns that increased drug usage comes with an increased risk of overdose.39 in other words, he contends, seps equal more overdoses. attorney general hill’s skepticism is well-meaning – he writes passionately and empathetically – but it 31. see generally metro. area planning council, addressing the opioid epidemic: connecting people to services 1 (2019), https://www.mapc.org/resource-library/addressing-theopioid-epidemic-connecting-people-to-services/ [https://perma.cc/7w3s-nyz7]. 32. george washington univ. milken sch. of pub. health, supra note 6, at 13. 33. 5-point strategy to combat the opioid crisis, u.s. dep’t health & hum. serv., https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html [https://perma.cc/3j9bltdp] (last visited apr. 1, 2021). 34. see generally nat’l league of cities & nat’l ass’n of ctys., a prescription for action: local leadership in ending the opioid crisis 18, 36 (2016), https://opioidaction.org/ report/ [https://perma.cc/cwv4-affh] (comparing the interest of cities and counties in combatting oud with the disparity between federal interests and local communities during the crack epidemic of the 1980s and 1990s). 35. curtis hill, handing out syringes to addicts is a perilous path, ind. fam. inst. (aug. 24, 2017), http://www.hoosierfamily.org/blog/curtis-hill-handing-out-syringes-addicts-perilous-path [https://perma.cc/pd9m-gjy7]. 36. see jill sheridan, city-county council approves syringe exchange, wfyi indianapolis (june 18, 2018), https://www.wfyi.org/news/articles/syringe-exchange-approved-for-marion-county [https://perma.cc/djx3-3f5b]. 37. hill, supra note 35. 38. id. 39. id. https://perma.cc/f9vc-7fq3 2021] localism and the opioid crisis 447 is misplaced. experts from the richard m. fairbanks foundation, the national research council, the institute of medicine, and the foundation for aids research – to name a few – generally agree that seps neither increase drug usage nor the risk of overdose.40 moreover, research indicates that not only do seps not increase drug use, but the presence of seps in a community does not expand drug-related networks or increase crime rates.41 at the bottom, states remain instrumental in enabling localities to enact solutions to combat oud. and, attorney general hill’s commentary is a good example of the kind of opposition that localities can face from state authorities. of course, as mentioned, the state itself continues to make strides. for example, indiana’s legislature has specifically enabled local governments to unilaterally declare a public health crisis in order to facilitate seps.42 and, governor holcomb has signed into law legislation, which has added new treatment centers and strengthened regulations on prescription-drug databases.43 but it is cities and counties – rather than the state – that are closest to their citizens. to that end, many cities are taking direct local action in the opioid crisis by implementing solutions such as pre-arrest diversions, targeted treatment, mental-health task forces, and gap coverage for long-term inpatient treatment.44 indiana cities and counties can and should follow such leads in their fight to combat oud. one such promising solution is the use of sifs. to be sure, there has yet to be a legally sanctioned sif in the united states.45 but recent attempts – including philadelphia’s safehouse, a proposed privately-run sif – are informative: the arguments advanced by proponents bring front-and-center the abundance of evidence-based research demonstrating the safety and efficacy of sifs and seps.46 40. see generally alex cohen, do needle exchanges lead to higher rates of drug abuse?, richard m. fairbanks found. (july 6, 2017), https://www.rmff.org/needle-exchanges-powerfulsolution-drug-abuse/ [https://perma.cc/zmv5-wkc9] [hereinafter do needle exchanges lead to higher rates of drug abuse?]; nat’l research council & inst. of med., preventing hiv transmission: the role of sterile needles and bleach 198-252 (jacques normand et. al. eds., 1995); public safety, law enforcement, and syringe exchange, amfar (mar. 2013), https://www.amfar.org/uploadedfiles/_amfarorg/articles/on_the_hill/2013/fact%20sheet%20 syringe%20exchange%20031413.pdf [https://perma.cc/qy3z-3b37]. 41. see generally melissa a. marx et al., trends in crime and the introduction of a needle exchange program, 90 am. j. pub. health. 1933 (2000). 42. ind. code § 16-41-7.5-5 (2021). 43. next level recovery indiana, supra note 24. 44. see opioid epidemic, mayors innovation project, https://www.mayorsinnovation. org/policy/health/opioid-epidemic/#examples [https://perma.cc/zlt5-53du] (last visited apr. 1, 2021). 45. lawrence o. gostin et al., supervised injection facilities legal and policy reforms, jama network (feb. 7, 2019), https://jamanetwork.com/journals/jama/fullarticle/2724457 [https://perma.cc/lw7p-gnwu] (noting that clandestine sifs have been operating in the united states). 46. see, e.g., brief for aids united et al. as amici curiae in support of appellees safehouse 448 indiana health law review [vol. 18:441 iv. supervised injection facilities and syringe exchange programs offer a safe and effective solution a. the efficacy of seps and sifs is well-established sifs have operated in europe for decades.47 their main objectives include: reducing the risks of disease transmission, preventing drug-related overdose deaths, and connecting drug users with treatment and other services.48 the operation of such a site is fairly straightforward; drug users come into a facility – with their own drugs – and are given sterile needles and a safe place to consume the drugs.49 participants are generally supervised by staff who may provide safety measures like providing fentanyl test strips and intervening with emergency care if necessary.50 some, like safehouse, may even provide participants with certified peer counselors, recovery specialists, social workers, and case managers.51 at no point in the process do sif staff provide or handle controlled substances.52 as of 2019, there were over ninety such facilities operating in europe.53 according to researcher dagmar hedrich, the european monitoring centre for drugs and drug addiction’s lead harm reduction scientist, there have been no fatal overdoses in european drug-consumption rooms.54 in 2003, insite – the first legally authorized sif in north america – opened in vancouver, british columbia.55 a second canadian sif followed suit in 2017.56 sifs in canada are & affirmance at 2-4, united states v. safehouse, 985 f.3d 225 (3d cir. 2021) (no. 20-1422), 2020 wl 3638487. 47. drug consumption rooms: an overview of provision and evidence, eur. monitoring ctr. for drugs & drug addiction (june 7, 2018), http://www.emcdda.europa.eu/topics/pods/ drug-consumption-rooms_en [https://perma.cc/n9ec-wep2] [hereinafter drug consumption rooms]; but see rick lineslmes, safe injection rooms save lives – yet the uk government continues to oppose them, conversation (oct. 24, 2019), http://theconversation.com/safeinjection-rooms-save-lives-yet-the-uk-government-continues-to-oppose-them-124952 [https://perma.cc/ysh4-z4sd]. 48. drug consumption rooms, supra note 47. 49. elana gordon, what’s the evidence that supervised drug injection sites save lives?, npr (sept. 7, 2018), https://www.npr.org/sections/health-shots/2018/09/07/645609248/whats-theevidence-that-supervised-drug-injection-sites-save-lives [https://perma.cc/5dfe-tssq]. 50. see united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019). 51. see id. 52. see id.; see also supervised consumption services, drug pol’y alliance, http://www. drugpolicy.org/issues/supervised-consumption-services [https://perma.cc/g6x8-5vql] (last visited apr. 2, 2021). 53. drug consumption rooms, supra note 47. 54. cara tabachnick, wary of an opioid epidemic, europe pushes safe sites for drug use, stan. soc. innovation rev. (2019), https://ssir.org/articles/entry/wary_of_an_opioid_epidemic_ europe_pushes_safe_sites_for_drug_use [https://perma.cc/578x-y5as]. 55. supervised consumption sites, vancouver coastal health, http://www.vch.ca/ 2021] localism and the opioid crisis 449 legally authorized under an exemption from prosecution under canadian drug law.57 if would-be operators of united states sites are looking for evidence of the efficacy of sifs, the canadian numbers are illuminating: there were 1,983 overdose interventions at just one vancouver sif in 2017 alone.58 many of the risks involved with injection drug use stem from not just the dangerous drug itself, but rather the scarcity of clean injection equipment, and user behavior linked to their fear of prosecution.59 for example, opiate overdose is often reversible with the use of naloxone, but those witnessing an overdose are often hesitant to administer it because of fear of legal ramifications.60 also, the likelihood of contracting diseases increases dramatically when users take to “shooting galleries,” which are public places like “homes – privately owned, abandoned, and otherwise – that are frequented by [users] for the purpose of injecting.”61 where needle exchanges and outreach certainly reduce the risk of blood-borne diseases associated with injection drug use, sifs are unique in that they can address both the need for a hygienic setting as well as allay problems related to the “behavioral influence . . . and other factors” present in shooting galleries.62 of course, it is unsurprising that a program where health workers oversee the use of illegal drugs – particularly injectable drugs – is subject to a lack of support and fears that the facility will increase crime.63 such attitudes are reflected at the highest level of law enforcement in the united states: deputy attorney general rod rosenstein promised prosecution of proposed sites, repeating the fallback argument of many detractors that sifs encourage drug use.64 indeed, there are a handful of examples of organizations around the united states working to enable public-health/harm-reduction/supervised-consumption-sites [https://perma.cc/xs35-nlvu29] (last visited apr. 2, 2021); see also lawrence o. gostin et al., supervised injection facilities legal and policy reforms, 321 jama 745 (2019) (noting that clandestine sifs have been operating in the united states). 56. supervised consumption sites, supra note 55. 57. id. 58. insite user statistics, vancouver coastal health, http://www.vch.ca/publichealth/harm-reduction/supervised-consumption-sites/insite-user-statistics [https://perma.cc/xc9378s3] (last visited apr. 2, 2021). 59. beletsky et al., supra note 21, at 231. 60. id. 61. id. 62. id. 63. see supervised consumption services, supra note 52. 64. bobby allyn, justice department promises crackdown on supervised injection facilities, npr (aug. 30, 2018), https://www.npr.org/sections/health-shots/2018/08/30/642735759/ justice-department-promises-crackdown-on-supervised-injection-sites [https://perma.cc/a5emvgyc]; see also jessica cohen, supervised injection facilities face obstacles, but that shouldn’t stop them, health aff. (nov. 29, 2018), https://www.healthaffairs.org/do/10.1377/hblog 20181127.121405/full/ [https://perma.cc/yde3-yjdm] (detailing some of the common objections to sifs). 450 indiana health law review [vol. 18:441 sifs and seps in their own communities, and each was met with more than a modicum of opposition.65 b. local attempts at sifs in the united states have been mostly unsuccessful thanks to recent litigation, the best-known example of a sif in the united states is probably philadelphia’s safehouse.66 safehouse is front-and-center in the sif conversation because it was recently the subject of a federal lawsuit.67 although safehouse may be the most recent attempt, there are several other jurisdictions that have proposed or even approved implementing sifs.68 the following examples demonstrate the difficulties faced by sifs’ proponents. california governor jerry brown recently vetoed a proposed immunity statute that would have allowed sifs in the state.69 before governor brown’s veto, san francisco was on track to be the site of the first legally authorized sif in the united states.70 on the other side of the country, new york city’s mayor, bill de blasio, petitioned the new york health commissioner – who is authorized to license “research studies that may include the possession of controlled substances” – to issue a license that would allow the city to erect several injection sites under the premise that they would be legally authorized research centers.71 while initially, new york governor andrew cuomo had signaled support for such a proposal, there has been little movement on the initiative and, predictably, some hesitation.72 legislative efforts to allow facilities in denver were similarly abandoned.73 in king county, washington, initially, 65. see infra section iv-b (discussing challenges facing sifs in the united states); see also supervised injection sites are coming to the united states: here’s what you should know, u. s. cal. dep’t nursing (may 2, 2019), https://nursing.usc.edu/blog/supervised-injection-sites/ [https://perma.cc/jb74-lce4] (mentioning at least three united states cities considering sifs). 66. united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019). 67. allyn, supra note 64. 68. see supervised injection sites are coming to the united states: here’s what you should know, supra note 65. 69. german lopez, the trump administration’s threat against safe injection sites is working, vox (oct. 2, 2018), https://www.vox.com/policy-and-politics/2018/10/2/17927864/safeinjection-site-trump-jerry-brown-california [https://perma.cc/7grv-hfms]. 70. william neuman, de blasio moves to bring safe injection sites to new york city, n.y. times (may 3, 2018), https://www.nytimes.com/2018/05/03/nyregion/nyc-safe-injection-sitesheroin.html?smtyp=cur&smid=tw-nytmetro [https://perma.cc/ve7s-72la]. 71. id. 72. vaidya gullapalli, new york city plan for overdose prevention center runs into resistance by some officials, appeal (jan. 23, 2019), https://theappeal.org/politicalreport/newyork-city-plan-for-overdose-prevention-centers-runs-into-resistance/ [https://perma.cc/4uc3gknd]. 73. anna staver, colorado lawmakers won’t vote on safe injection sites in 2019. house democratic leader blames denver., denv. post (feb. 19, 2019), https://www.denverpost.com/ 2021] localism and the opioid crisis 451 successful efforts at erecting a municipally-run sif were withdrawn due to the looming threat of federal litigation.74 officials have premised their reluctance to move forward with sifs on everything from the perceived increase in drug abuse to fear of political consequences.75 this, of course, is nothing new – just remember our indiana examples with seps. but, why are state and local governments reticent when tasked with tamping down a problem with the magnitude of – in new york city’s case – one overdose death per six hours?76 one reason is undoubtedly concerned constituents. the so-called “not in my backyard” (“nimby”) factor “considerably erodes enthusiasm” for the proposal and implementation of sifs.77 indeed, public concerns were a factor in madison county, indiana’s abandonment of their sep in 2017.78 if seps can provoke enough backlash for a county to abandon life-saving measures, it is not difficult to guess that sifs would fare no better. in large part – and as far back as 2003 – the united states government’s opinion has reflected that of nimby evangelists.79 former drug-policy director john walters opined that “[t]here are no [such things] as safe injection sites.”80 yet a brief look into a handful of local attempts at combatting the opioid crisis reveals that local, government-run sifs and seps in indiana may not be entirely foreclosed. attitudes continue to change as the crisis persists. c. indiana municipalities are well-positioned to establish government-run sifs and seps indiana cities and counties are taking local action to combat the opioid crisis. the following examples of local governments’ willingness to enact such 2019/02/19/safe-injection-sites-denver-colorado/ [https://perma.cc/5ewl-nfwa]. 74. see kipp robertson, safe injection site on hold in seattle amid growing concerns, king 5 tv (mar. 12, 2019), https://www.king5.com/article/news/concerns-of-federal-retributionput-seattles-safe-injection-sites-on-hold/281-5b103ef2-f4c7-423a-b3c6-4ade74ab590b [https://perma.cc/5rbw-wy2l]. 75. see german lopez, supra note 69 (discussing how california’s governor described sifs as “enabling illegal drug use”); anna staver, supra note 73 (quoting patrick neville as saying that denver’s “concerned parents” are a possible hurdle). 76. n.y. city health, epi data brief: unintentional drug poisoning (overdose) deaths in new york city, 2000 to 2017, at 1 (2018), https://www1.nyc.gov/assets/doh/ downloads/pdf/epi/databrief104.pdf [https://perma.cc/8ceh-elct]. 77. goldberg, supra note 2; cf. beletsky et al., supra note 21, at 231-37. 78. charles taylor, the benefits and challenges of needle exchange programs, nat’l ass’n counties (feb. 20, 2019), https://www.naco.org/articles/benefits-and-challenges-needleexchange-programs [https://perma.cc/f3fw-rqqz]. 79. deneen l. brown, canada’s drug policy gives ‘safe injection sites’ a shot, chi. trib. (aug. 7, 2003), https://www.chicagotribune.com/news/ct-xpm-2003-08-07-0308070162-story.html [https://perma.cc/9c9a-yruw]. 80. id. 452 indiana health law review [vol. 18:441 measures demonstrate that the ground may be fertile for going a step further and enacting locally implemented sifs and seps. and, the fact that many such attempts have since been abandoned or lost funding only highlights the pressing need for solutions. 1. pre-arrest diversions and mental health initiatives pre-arrest diversion is one way some cities are tackling low-level drug crimes.81 law enforcement assisted diversion (“lead”) is a seattle-based nonprofit organization aimed at harm reduction through the use of pre-arrest diversions.82 in cities that have adopted programs with lead-like principles, low-level drug offenders are typically referred to case-management programs where they may receive support such as housing assistance and drug treatment.83 indianapolis is one of a handful of cities across the united states that implemented a pre-arrest diversion program. indiana cities and counties did not develop lead programs but instead something called crisis intervention teams, which function to effectuate pre-arrest diversions with the stated goal of “support[ing] collaborative efforts to create and sustain . . . effective interactions among law enforcement, mental health care providers . . . and communities . . . to reduce the stigma of mental illness.”84 in indianapolis, this mental health-based pre-arrest diversion program was called mobile crisis assistance team (“mcat”).85 indianapolis’s mcat program was established by mayor joe hogsett.86 notably, indiana law dealing with the means by which a court may conditionally defer prosecution for certain drug charges does not mandate that deferment must be issued by judicial proceedings.87 as such, any challenge to mcat’s pre-arrest diversions would have to come from the state assessing that it had preempted such a program by mandating deferment by judicial proceedings. of course, it has not. in the absence of preemptive legislation, prearrest diversions are valid exercises of local law-enforcement authority.88 during mcat’s pilot program, less than 2% of individuals who interacted 81. nat’l league of cities & nat’l ass’n of ctys, supra note 34. 82. what is lead?, lead nat’l support bureau, https://www.leadbureau.org/about-lead [https://perma.cc/39wn-88zb] (last visited apr. 2, 2021). 83. id. 84. crisis intervention teams, nat’l all. on mental illness ind., https://www. namiindiana.org/criminal-justice/cit-1 [https://perma.cc/gz55-99gj] (last visited feb. 2, 2020). 85. katie bailey & brad ray, evaluation of the indianapolis mobile crisis assistance team: report to the indianapolis office of public health & safety and the fairbanks foundation 1 (2018), https://ppidb.iu.edu/uploads/publicationfiles/mcat%20pilot %20evaluation%20final%20report.pdf [https://perma.cc/92ns-h4vk]. 86. id. 87. ind. code §§ 12-23-5-0.5 to -9 (2021). 88. see infra section v (discussing indiana’s delegation of home rule authority to local units to govern their own affairs). 2021] localism and the opioid crisis 453 with mcat responses were transported to jail.89 unfortunately, there were some barriers to mcat’s success, such as unclear policy guidelines leading to confusion by officers as to how the program should be carried out.90 indianapolis’s mcat program was eventually scaled back as the indianapolis emergency medical services pulled out of their partnership with officers.91 in mayor hogsett’s 2019 state of the city address, however, he noted a renewed interest – by the state – in the mcat program.92 2. syringe exchange programs seps have been proven to decrease the number of overdose incidents, lower the spread of disease, and provide an important connection point between users and harm reduction services and treatment.93 in indiana, a city or county’s power to unilaterally declare a public health emergency is granted by statute.94 indiana’s short history of its sep has been met with varying degrees of acceptance and criticism.95 the existence of such an enabling statute demonstrates that the legislature is both aware of the local nature of the opioid crisis as well as willing to give cities the latitude to implement innovative solutions. and, that is a good start. but, as i explain in section vii-b-2, the enabling statute faces a sunset date, which remains in effect at the time of writing this note.96 so, when it does sunset, the need for local action will become even more pressing as cities and counties look to implement possible solutions in the face of seps’ uncertain future. because a syringe can be considered drug paraphernalia and the possession of paraphernalia is expressly prohibited by indiana law, opponents’ first inclination might be to assert that indiana’s home rule act would not enable indiana cities to declare such an emergency.97 again, it is a matter of framing the issue – it is 89. bailey & ray, supra note 85. 90. id. 91. ryan martin, indianapolis ems pulls out of mcat partnership with impd, eskenazi, indystar (dec. 29, 2018), https://www.indystar.com/story/news/crime/2018/12/29/indianapoliscrime-ems-pulls-out-partnership-impd-eskenazi/2214721002/ [https://perma.cc/nr3n-4p4m]. 92. drew daudelin, in state of the city address, hogsett pitches overhaul for infrastructure funding, wfyi indianapolis (may 29, 2019), https://www.wfyi.org/news/articles/in-state-of-thecity-address-hogsett-pitches-overhaul-for-infrastructure-funding [https://perma.cc/7zn5-r8mb]. 93. see generally do needle exchanges lead to higher rates of drug abuse?, supra note 40; see also nat’l research council & inst. of med., supra note 40. 94. ind. code § 16-41-7.5-5(2) (2021). 95. compare hill, supra note 35 (criticizing seps in indiana), with erika l. chapman, syringe services programs in indiana, richard m. fairbanks sch. pub. health, https://fsph. iu pu i . edu /doc / r esea rch -cen te r s /2 0 1 8 0 4 2 7 -ii-s yr in g e s e r v i c e s -programs .pdf [https://perma.cc/kv7v-mx7b] (last visited apr. 2, 2021) (detailing how, in 2017, governor holcomb signed indiana’s syringe exchange bill into law); see also § 16-41-7.5-5(2) (giving cities the power to unilaterally declare public health emergencies necessitating seps). 96. ind. code § 16-41-7.5-14 (2021). 97. see ind. code § 35-48-4-8.3 (2021). 454 indiana health law review [vol. 18:441 only a criminal issue if it is framed as such.98 3. opposition to consider between seps and sifs, sifs are probably the most unsettled of oudfighting solutions. while the indiana legislature could expressly grant a municipality the authority to operate such a site, at present it is extraordinarily unlikely that the state will take such a bold action; not only because of the indiana attorney general’s position but also due to recent and continued threats by the united states government to shut down such a site.99 moreover, indiana case law is all but silent about the boundaries of cities and counties to act unilaterally: in a slimline of cases, the indiana supreme court has held that there are a variety of things that are permissible pursuant to home rule authority, but none of them are health-and-safety measures.100 so, local governments have two options: to expend the energy getting a bill passed by the general assembly (and being subject to the restrictions of such a bill if one is passed) or get “local consensus” and “shift[] the burden of legal action to [a sif’s or sep’s] opponents.”101 in the long run, shifting attitudes, continued studies regarding the efficacy of such facilities, and increased visibility “will probably lead to legislation throughout the nation clarifying [their] legal status.”102 local governments have an opportunity to be a part of this important “clarifying” process on the ground level – by leveraging data-driven statistics and state law to frame sifs and seps as life-saving measures. framing the issue as one of health and safety, for instance, can be effective: consider philadelphia’s safehouse – who framed the issue of oud and the opioid crisis as one of public health rather than a criminal concern.103 of course, safehouse is a private nonprofit organization and does not seek to open a facility that is government-run – the district court judge in safehouse expressly noted such.104 in cases where local government is pitted against state or federal 98. see, e.g., the legal strategies used in operating syringe exchange programs in the united states, supra note 16 (outlining several successful local attempts at implementing seps despite the lack of legal authority). 99. see, e.g., allyn, supra note 64. 100. see, e.g., city of north vernon v. jennings northwest reg’l utils., 829 n.e.2d 1 (ind. 2005) (addressing the city’s right to provide sewer services to a school within corporate limits); city of gary ex rel. king v. smith & wesson corp., 801 n.e.2d 1222, 1225 (ind. 2003) (addressing the city’s right to bring a nuisance action against a handgun manufacturer); city of crown point v. lake county, 510 n.e.2d 684 (ind. 1987) (addressing the city’s ability to exercise zoning authority over county government property); dvorak v. city of bloomington, 796 n.e.2d 236 (ind. 2003) (addressing the city’s ability to limit the number of single adults in a dwelling). 101. see the legal strategies used in operating syringe exchange programs in the united states, supra note 16, at 1165 (emphasis added). 102. id. (commenting on government officials using local consensus to justify seps). 103. see united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019). 104. who we are, safehouse, https://www.safehousephilly.org/who-we-are [https://perma. 2021] localism and the opioid crisis 455 government, however, preemption issues will undoubtedly be raised.105 and, indeed, the legislature can be a daunting consideration. in indiana, the state general assembly’s “determination of public policy [is] afforded wide discretion.”106 and, local policy determinations are subject to express preemption by state action.107 so, understood, it does not seem too big a leap to imagine that indiana city and county action could take a backseat to legislative determinations – especially in dealing with measures such as sifs and seps. to be sure, there is a good indication that when a locality does something that is not palatable to the general assembly, legislation can be passed in an attempt to stop local efforts in their tracks.108 local government, then, can expect vigorous state challenges to sifs. local efforts in indiana are illustrative of this push and pull between local units and the state legislature. for instance, marion county elected prosecutor ryan mears recently announced his office’s intentions not to file charges in certain marijuana cases.109 but the general assembly responded with a bill that would allow the attorney general to appoint a special prosecutor to prosecute crimes in cases where the local prosecutor “refuses as a matter of public policy to prosecute those crimes.”110 cc/jw5b-tckj] (last visited apr. 2, 2021). 105. see, e.g., emerald steel fabricators, inc. v. bureau of labor & indus., 348 ore. 159 (or. 2010) (discussing how a state statute that authorized the use of medical marijuana was preempted by csa); people v. crouse, 388 p.3d 39 (colo. 2017) (discussing how a state provision for the return of a defendant’s medical marijuana after acquittal was preempted by csa); but see ter beek v. city of wyoming, 846 n.w.2d 531 (2014) (holding that a state statute authorizing the use of medical marijuana was not preempted by csa and citing anti-commandeering principles). 106. hoagland v. franklin township cmty. sch. corp., 27 n.e.3d 737, 749 (ind. 2015) (citing walton v. state, 398 n.e.2d 667, 670–71 (ind.1980)). 107. see, e.g., city of gary v. indiana bell tel. co., 732 n.e.2d 149 (2000) (holding that even though the city’s ordinance was permissible under the home rule act, it became impermissible when the indiana legislature passed legislation expressly preempting the city’s ordinance). 108. see generally holcomb v. city of bloomington, 158 n.e.3d 1250 (ind. 2020) (addressing the city’s action for declaratory judgment against the governor, which challenged a “statute that stopped [the] city’s proposed annexation of several areas of land”). 109. crystal hill & ryan martin, marion county will no longer prosecute simple marijuana possession, officials say, indystar (sept. 30, 2019), https://www.indystar.com/story/news/ 2019/09/30/marion-county-no-longer-prosecute-marijuana-possession-officials-say/3818748002/ [https://perma.cc/ck3b-nu4b]. 110. see s.b. 436, 121st gen. assemb., 1st reg. sess. (ind. 2020) (proposing to allow the attorney general to appoint a special prosecutor to prosecute certain crimes if the prosecuting attorney “refuses as a matter of policy to prosecute those crimes”); see also rich van wyk, republican senator’s bill targets prosecutor for not enforcing marijuana law, wthr (jan. 24, 2020), https://www.wthr.com/article/republican-senators-bill-targets-prosecutor-not-enforcingmarijuana-law [https://perma.cc/2pne-qusc] (noting that the proposed legislation is likely aimed at the marion county prosecutor’s decision to withhold prosecution for possession of less than one ounce of marijuana). 456 indiana health law review [vol. 18:441 so, there is a lot for localities to consider when working under the eye of the state – especially on hot-button issues like drug abuse and prevention. but there is at least a starting point for acting unilaterally: indiana’s home rule act. v. indiana’s home rule act offers a legal basis for municipal supervised injection facilities and syringe exchange programs in 1868, in city of clinton v. cedar rapids and missouri river railroad company, the iowa supreme court held that a local government may engage in activity only if it is expressly sanctioned by the state government.111 this doctrine – that local units only had powers that were expressly given to them by the state – came to be known as dillon’s rule, after city of clinton’s author, justice john dillon.112 it was reinforced by the united states supreme court in hunter v. city of pittsburgh.113 under dillon’s rule, local government was relegated to lobbying the state legislature to get express authority for anything the city wished to accomplish.114 essentially, dillon’s rule is a rule of statutory construction whereby any question as to whether a municipality is able to act is resolved with the strong presumption that the legislature intended on reserving that power exclusively for the state.115 on the other end of the spectrum was justice dillon’s contemporary, justice thomas cooley of the supreme court of michigan.116 justice cooley’s views on municipal autonomy stood in stark contrast with justice dillon’s dismissive view of local government as simply an administrative appendage of the state.117 justice cooley wrote in 1871 that “[t]he state may [mold] local institutions according to its views of policy or expediency; but local government is [a] matter of absolute right; and the state cannot take it away.”118 the inflexibility of dillon’s rule would eventually lead to many states adopting their own home rule statutes.119 inspired by cooley, the home rule movement really kicked off when missouri enacted a constitutional home rule 111. see city of clinton v. cedar rapids & mo. river r.r., 24 iowa 455 (1868). 112. see mun. tech. advisory serv., dillon’s rule – relationship of municipalities to the state, u. tenn. (nov. 18, 2019), https://www.mtas.tennessee.edu/reference/dillons-rule [https:// perma.cc/u8kp-9jal]. 113. hunter v. city of pittsburg, 207 u.s. 161, 178 (1907) (asserting that “[t]he state . . . at its pleasure, may modify or withdraw all such [municipal] powers” and that this “[a]ll . . . may be done . . . without the consent of the citizens”). 114. see cities 101 – delegation of power, nat’l league cities (dec. 13, 2016), https://www.nlc.org/resource/cities-101-delegation-of-power [https://perma.cc/yc2m-z25r]. 115. see generally richardson, supra note 20, at 662 (going to great lengths to emphasize that dillon’s rule is a form of interpreting legislative intent whereas home rule tends to be less of an abstract doctrine and is usually a constitutional provision or statute). 116. see id. at 669. 117. see id. 118. people ex rel. leroy v. hurlbut, 24 mich. 44, 108 (1871) (emphasis added). 119. see cities 101 – delegation of power, supra note 114. 2021] localism and the opioid crisis 457 provision.120 indiana is one of many states that have since adopted such a provision, the home rule act.121 rejecting the operative theme of dillon’s rule, the home rule act provides that the notion that a unit of municipal government has only “powers expressly granted by statute . . . is abrogated.”122 indiana’s home rule act gives localities “all . . . powers necessary or desirable in the conduct of its affairs, even though not granted by statute.”123 since indiana’s home rule act gives broad leeway to local government,124 indiana cities and counties do not necessarily have to rely on specifically enumerated statutory provisions in combatting oud. indiana cities are granted both express statutory authority as well as allowed to act on their own pursuant to indiana’s home rule act in the arena of oud. vi. how local supervised injection facilities and non-statutory syringe exchange programs could work in indiana judicial attitudes in the state are generally open to dialogue as it pertains to the opioid crisis: indiana supreme court chief justice rush has expressed her concern over a crisis “that is getting worse by the day.”125 others have echoed these sentiments: marion county superior court judge william nelson has urged his colleagues to “make it easier for those who suffer from substance use disorder to get the help they so desperately need.”126 but judicial acknowledgment of the problem does not mean local government could (or should) rely on the judiciary. local consensus is critical.127 locally, indianapolis’s city-county council and mayor hogsett have been generally amenable to innovative solutions in combatting oud.128 and, as previously discussed, the elected marion county prosecutor has expressed concern over the application of state drug law. indianapolis, at the time of writing 120. jesse j. richardson et al., is home rule the answer? clarifying the influence of dillon's rule on growth management 10 (2003), https://www.brookings.edu/wpcontent/uploads/2016/06/dillonsrule.pdf, [https://perma.cc/2pgd-nedy]. 121. samuel b. stone, home rule in the midwest 2 (2010), http://ppidb.iu.edu/uploads/ publicationfiles/pc_hmrules_web.pdf [https://perma.cc/fhq8-ytej]. 122. ind. code § 36-1-3-4(a) (2021). 123. ind. code § 36-1-3-4(b) (2021). 124. id. (granting “all . . . powers necessary or desirable in the conduct of its affairs, even though not granted by statute”). 125. see katie stancombe, opioid summit focuses on treatment, best judicial practices, ind. law. (july 25, 2018) https://www.theindianalawyer.com/articles/47673-opioid-summitfocuses-on-treatment-best-judicial-practices [https://perma.cc/uy3m-bd3x]. 126. id. 127. see generally the legal strategies used in operating syringe exchange programs in the united states, supra note 16. 128. see, e.g., sheridan, supra note 36; bailey & ray, supra note 85. 458 indiana health law review [vol. 18:441 this note, has mobile syringe exchanges.129 this is especially relevant since the united states department of justice (“doj”) has explicitly conceded that a sif, if executed through mobile vans, would not run afoul of the controlled substances act (“csa”).130 while judge gerald mchugh in his safehouse memo called this position “myopic textualism,”131 this concession carries considerable weight in a county like marion where mobile harm reduction has been implemented. all these considerations make marion county the most viable candidate for testing the viability of a sif in indiana. of course, there is the matter of framing the issue, but the hurdles should be considered first – the csa and state law. and, in order to reach the concerns under the csa, state hurdles must first be cleared. the starting point to clearing any state hurdle is indiana’s home rule act – since that is where the authority would come from – and any relevant portion of the indiana code that may be in conflict: a municipality would have to first analyze relevant indiana law to search for possible preemption. a. county-run sifs and possible hurdles the indiana home rule act’s preemption provision prohibits local regulation of “conduct that is regulated by a state agency, except as expressly granted by statute.”132 so the question in the context of sifs and seps becomes: does the state already regulate this? a possible hurdle that marion county could face is indiana code section 12-23-18-0.5, which outlines requirements for opioid treatment programs in indiana133 – that is, if the state decided that a sif was an opioid treatment program rather than a preventative harm reduction measure and that there was no significant difference between the two.134 but that interpretation would be inapposite: the language of the statute explicitly refers to overdose reversal and medicated-assisted treatment, and it makes no mention of overdose prevention.135 indeed, indiana code section 12-7-2-135.6 defines an “opioid 129. safe syringe access and support program, marion county pub. health dep’t, http://marionhealth.org/safesyringe/ [https://perma.cc/a6j2-klbs] (last visited apr. 2, 2021). 130. united states v. safehouse, 408 f. supp. 3d 583, 614 (e.d. pa. 2019). 131. id. 132. ind. code § 36-1-3-8 (2021). 133. ind. code § 12-23-18-0.5 (2021). 134. see principles of harm reduction, nat’l harm reduction coalition, https:// harmreduction.org/about-us/principles-of-harm-reduction/ [https://perma.cc/2hp7-s449] (last visited apr. 2, 2021). the national harm reduction coalition outlines harm reduction as accepting that drug use is "part of our world" and choosing “to minimize its harmful effects rather than ignore or condemn them." id. among the methods listed on the organization’s website are syringe exchanges, sifs, and overdose prevention. id.; but see effective treatments for opioid addiction, nat’l inst. on drug abuse, https://www.drugabuse.gov/publications/effective-treatments-opioidaddiction/effective-treatments-opioid-addiction [https://perma.cc/l6g9-remt] (last updated nov. 2016) (associating treatment for oud with mat rather than preventive or harm reduction measures such as syringe exchanges and sifs). 135. see § 12-23-18-0.5. 2021] localism and the opioid crisis 459 treatment program” as a program “through which opioid agonist medication is dispensed to an individual in the treatment of opiate addiction.”136 in indiana, the “primary rule of statutory construction is to ascertain and give effect to the intent of the legislature.”137 the best way to do this is through “the language of the statute itself.”138 here, section 12-7-2-135.6 makes clear that an opioid treatment program is a program whereby drugs are dispensed.139 a sif would not be primarily providing treatment; it would be primarily providing harm reduction – or, in other words, “accept[ing] . . . illicit drug use [a]s part of our world and choos[ing] to . . . minimize its harmful effects.”140 further, section 12-7-2-135.6 defines a treatment program as dispensing medication,141 so even if the state wanted to characterize a sif as a “treatment” program, it would not make any meaningful difference because a sif – or a sep for that matter – would not be dispensing medication at all.142 it is difficult to see how a local government-run sif would be preempted by section 12-23-18-0.5 since the operation of a sif, and that of the facility contemplated by section 1223-18-0.5 (as defined by section 12-7-2-135.6), would be completely different facilities: one, which the statute contemplates, a facility where medication is given to patients; the other, a sif, where patients are supervised while they consume their own substances. a. non-statutory syringe exchange programs: statutory authority may not be all it is cracked up to be the home rule act’s preemption provision also directly implicates sifs and seps because possession of drug paraphernalia is in the purview of the state.143 sep enabling statutes are often seen as an “important step” in harm reduction and avoiding the criminalization of syringes obtained through these programs.144 true, indiana law makes it a level 6 felony to possess a hypodermic syringe “for the use of a controlled substance . . . by injection.”145 so, it would seem that without a statute expressly exempting seps from the reach of section 16-42-19-18, seps are preempted by state law. but, as far back as the 1990s, there have been several instances of local governments “reject[ing] the common assumption that drug 136. ind. code § 12-7-2-135.6 (2021) (emphasis added). 137. hendrix v. state, 759 n.e.2d 1045, 1047 (ind. 2001). 138. id. (quoting chambliss v. state, 746 n.e.2d 73, 77 (ind. 2001)). 139. § 12-7-2-135.6. 140. principles of harm reduction, supra note 134. 141. § 12-7-2-135.6. 142. supervised consumption services, supra note 55 (describing how staff members of sifs “do not directly assist in consumption or handle any drugs brought in by clients”). 143. ind. code § 35-48-4-8.3 (2020). 144. nicholas j. golding, the needle and the damage done: indiana's response to the 2015 hiv epidemic and the need to change state and federal policies regarding needle exchanges and intravenous drug users, 14 ind. health l. rev. 173, 201 (2017). 145. ind. code § 16-42-19-18 (2020). 460 indiana health law review [vol. 18:441 laws govern the legal analysis of [seps].”146 indeed, there is really no meaningful immunity to syringe possession law conferred upon participants of seps by indiana’s enabling statute. in leatherman v. state, the indiana court of appeals held that the indiana sep statute “was not intended to – and does not – confer upon its participants immunity from prosecution for possession of paraphernalia.”147 the statute functions, the court reasoned, to “prohibit[] mere possession of a needle obtained through [a sep] . . . as the bas[i]s for arrest or prosecution.”148 so, while a would-be defendant cannot be prosecuted simply for obtaining the syringe through a sep, a person could, nevertheless, “be found guilty of possession of paraphernalia if there was evidence that he intended to use those syringes for unlawful ends.”149 this “distinction” does not offer any actual protection for the end-user. there does not appear to be any meaningful immunity conferred on the end-user of statutorily authorized seps at all. to be sure, the statute at least functions as immunity for the operators of seps: “qualified entities” are expressly permitted to administer such programs.150 but this presents the question: in the absence of the enabling statute, just what exactly would sep operators be doing that is criminally actionable? surely, the operators of the sep would not be in possession of a syringe with the intent to use the syringes for “unlawful ends” – as leatherman would have it – they would be in possession of syringes with the intent to curb the outbreak of a disease or mitigate harm in cases of oud. and, the operators would not be in possession of a syringe to use the syringe at all. this is precisely the point at which the defense of a county-run sif and the defense of a county-run sep would merge: the primary purpose (or intent in the case of indiana’s syringe possession law) for both would not be in contravention with the csa’s proscription of unlawfully using drugs, nor the intent to commit an offense as outlined in indiana code section 35-48-4. the purpose and intent of a local sifs or seps would be exclusively to provide “lifesaving medical care to those at risk of drug overdose.”151 b. consensus and prosecutorial discretion one of the most important tools for indiana cities and counties looking toward a locally sanctioned sif or sep is consensus.152 building local consensus 146. the legal strategies used in operating syringe exchange programs in the united states, supra note 16, at 1164. 147. leatherman v. state, 101 n.e.3d 879, 886 (ind. ct. app. 2018). 148. id. 149. id. 150. ind. code §§ 16-41-7.5-3, -4, -6 (2021). 151. defendant safehouse’s answer, affirmative defenses, counterclaims to plaintiff's complaint, and third-party complaint at 5, united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019) (no. 2:19-cv-00519), 2019 wl 8723727. 152. see the legal strategies used in operating syringe exchange programs in the united 2021] localism and the opioid crisis 461 is often easier than convincing the general assembly.153 getting a bill passed by the general assembly requires a “considerable” expenditure of energy and funds and requires building a cohesive coalition of legislators across the state.154 and, the process can entail exhaustive and often unproductive efforts in lobbying “indifferent or hostile” legislators not attuned to local needs.155 local consensusbuilding has the critical effect of “shifting the burden of legal action to opponents” – and there is not even a guarantee that opponents would take action.156 building local consensus means including everyone in the conversation. local government is not just the mayors and city council people, but the “network[] of local leaders and institutions” that provide the “architecture of localism.”157 that includes local law enforcement. consensus between local law enforcement groups and public officials can be beneficial in allaying the negative effects of substance-abuse laws: indianapolis mayor hogsett, commenting about marion county prosecutor ryan mears’s decision to not prosecute low-level marijuana possession, said that he “want[s] to be supportive of anything [the] community needs to do to make [the] criminal justice process equitable and fair.”158 marion county sheriff kerry forestal welcomed the decision.159 the negative reactions to mears’s decision are a telling roadmap for what a municipality could expect if it were to unilaterally enable a sep. the decision was described as “abrupt” and the indianapolis fraternal order of police commented that the policy raised “significant concerns” about an official “unilaterally” refusing to enforce state law.160 mears’s policy also faced opposition from indiana’s legislature; senate republican mike young authored senate bill 436, which would allow the attorney general to appoint a special prosecutor if a local prosecutor “has announced as a matter of policy that the prosecuting attorney will not enforce all or part of a criminal statute enacted by states, supra note 16, at 1165. 153. id. 154. id. 155. id. 156. id. (noting that “the experience of [seps] to date suggests that not every public official who would refuse to support [a sep] would undertake to act affirmatively against it). 157. michael hendricks, the case for local government, real clear pol’y (mar. 4, 2019), https://www.realclearpolicy.com/articles/2019/03/04/the_case_for_local_government_111089.html [https://perma.cc/b9hn-b5yq]. 158. kelly reinke, impd, mayor hogsett react to prosecutor’s announcement to not pursue minor marijuana cases, fox 59 (oct. 1, 2019), https://fox59.com/news/impd-mayor-hogsett-reactto-prosecutors-announcement-to-not-pursue-minor-marijuana-cases/ [https://perma.cc/n3qche92]. 159. olivia covington, halt of simple pot prosecution gets mixed reaction, ind. law. (oct. 16, 2019), https://www.theindianalawyer.com/articles/halt-of-simple-pot-prosecutions-gets-mixedreaction [https://perma.cc/3dk4-z4ml]. 160. id. 462 indiana health law review [vol. 18:441 the [g]eneral [a]ssembly.”161 the bill died when no action was taken before a critical deadline.162 ostensibly, mears’s policy will remain in effect for now. but, his detractors’ accusations of “abruptness” and criticism regarding the unilateral nature of his actions suggest that a little more discussion toward a broader consensus could have insulated him from some of these attacks. so, in addition to “reject[ing] the common assumption that drug laws govern the legal analysis” of seps or sifs, local cooperation with the prosecuting authority is vital.163 one could imagine a situation where, in the absence of an enabling statute, the marion county prosecutor’s office decided it would not enforce prohibitions on syringe possession if the syringes were obtained through a locally authorized sep – and the marion county prosecutor’s office would work collaboratively with local police and city-county council members. and, since the state’s commandeering of prosecutorial authority from locally-elected officials is a move that carries “a good deal of baggage,” there is a distinct possibility that the situation could turn out like the general assembly’s nowdefunct challenge to mears: a controversial and disagreed-with decision that ultimately remains unscathed.164 of course, cooperation only gets a local government so far. a spokesperson for the current united states drug enforcement administration claimed that “[sifs], so-called safe injection sites, violate federal law.”165 so, any locality attempting to open a sif will be subject to the looming threat of federal law enforcement action. 161. s.b. 436, 121st gen. assemb., 1st reg. sess. (ind. 2020); see also olivia covington, social justice prosecuting bill advances despite opposition, ind. law. (feb. 5, 2020), https://www.theindianalawyer.com/articles/social-justice-prosecuting-bill-advances-despiteopposition [https://perma.cc/r7qs-ryks]. 162. associated press & il staff, senator drops push to force indiana marijuana prosecutions, ind. law. (feb. 5, 2020), https://www.theindianalawyer.com/articles/senator-dropspush-to-force-indiana-marijuana-prosecutions [https://perma.cc/b5ny-v3ua]. 163. the legal strategies used in operating syringe exchange programs in the united states, supra note 16, at 1164. 164. see associated press & il staff, supra note 162 (quoting republican house speaker brian bosma on the matter of the state intervening in local prosecutions). 165. dominic holden, the trump administration says proposed heroin injection sites could face “legal action,” buzzfeed news (feb. 14, 2018), https://www.buzzfeednews.com/article/ dominicholden/the-trump-administration-says-proposed-heroin-injection?bfsource=relatedmanual [https://perma.cc/j536-bpbm]. 2021] localism and the opioid crisis 463 vii. the “crack house statute” presents a significant hurdle to municipal supervised injection facilities and syringe exchange programs a. the doj and the “crack house” challenge the csa presents the most imminent threat to the implementation of sifs.166 the current doj strategy, as evidenced by the safehouse order, is that sifs are prohibited by the csa because they are used for the purpose of unlawfully using a controlled substance pursuant to 21 u.s.c. section 856(a).167 section 856(a), also known as the “crack house statute” because of its enactment to fight the crack epidemic in the 1980s, is the most often advanced provision under the csa for why sifs violate federal law.168 the crack house statute makes it unlawful to “open, lease, rent, use, or maintain any place . . . for the purpose of manufacturing, distributing, or using any controlled substance.”169 it also extends to anyone who “manage[s] or control[s] any place . . . or make[s] available for use . . . the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.”170 although the statute appears broad-reaching on its face, in its early days, the crack house statute was used as a basis for the conviction of defendants who sold or manufactured drugs out of their homes.171 most cases tied the statutory “purpose” to a business-like context: in the tenth circuit, that meant having the “characteristics of a business”; the focus in the seventh circuit has been on “significant commercial sales”; and, in the fifth circuit, “manufacturing and distribution.”172 there is now at least some general agreeance among scholars and circuit courts that the crack house statute also covers premises maintained for the purpose of consumption.173 this is currently where sifs face their biggest 166. united states v. safehouse, 408 f. supp. 3d 583, 614 (e.d. pa. 2019). 167. id. 168. see generally id.; see also alex kreit, safe injection sites and the federal “crack house” statute, 60 b.c. l. rev. 414 (2019). 169. 21 u.s.c. § 856 (a)(1) (2020). 170. 21 u.s.c. § 856(a)(2) (2020). 171. see, e.g., united states. v. morgan, 117 f.3d 849, 856 (5th cir. 1997) (involving a defendant who was selling drugs out of a house “in the projects”); united states. v. verners, 53 f.3d 291 (10th cir. 1995) (describing how the primary purpose of maintaining a house was to manufacture crack-cocaine); united states v. church, 970 f.2d 401, 406 (7th cir. 1992) (broadening the crack house statute to include maintaining a house for “the purpose of” crack distribution). 172. see verners, 53 f.3d at 296 (describing the characteristics of a business); church, 970 f.2d at 406 (describing significant commercial sales); united states v. roberts, 913 f.2d 211, 221 (5th cir. 1990) (describing manufacturing and distribution). 173. see, e.g., united states v. shetler, 665 f.3d 1150, 1164 (9th cir. 2011) (noting that the crack house statute could apply in some situations where there is evidence that “numbers of nonresident individuals” are actively involved in drug consumption); see also michael e. rayfield, 464 indiana health law review [vol. 18:441 challenge. yet there is disagreement about just what the crack house statute’s “purpose” looks like. b. the primary purpose defense safehouse’s success at the district court level hinged mainly on its “primary purpose” defense to the doj’s application of the crack house statute.174 safehouse’s primary purpose defense essentially stated that the primary purpose for which safehouse would operate was not for the use, manufacture, or distribution of drugs but rather for the “exclusive purpose of providing urgent, lifesaving medical care to those at risk of drug overdose.”175 while in safehouse the eastern district of pennsylvania used the “primary purpose” test in terms of consumption, other circuit courts are split on the issue of purpose. for example, the fifth circuit uses “significant purpose.”176 in united states v. soto-silva, the fifth circuit explained that, although there may be a different primary purpose for maintaining the premises, as long as drug distribution was “at least a significant purpose,” the activity ran afoul of the crack house statute.177 the seventh circuit, in contrast, does not explicitly require that the purpose be primary or significant but instead speaks in terms of the character of the purpose for which the premises are being maintained.178 the problem in the context of sifs, however, is that drugs are being neither distributed nor manufactured.179 as of writing this note, no circuit court has directly addressed how to properly assess whether premises are being used for “the purpose” of facilitating the use of controlled substances. we do know, however, that casual drug use in one’s home – where the person in control of the premises is the user – is generally considered by circuit courts to be outside of the scope of the crack house statute. this is the case in at least the ninth, sixth, and d.c. circuits.180 but, judge mchugh’s painstakingly analytical opinion in safehouse suggests how difficult the facilitation of drug use pure consumption cases under the federal “crackhouse” statute, 75 u. chi. l. rev. 1805, 181718 (2008) (recognizing that the crack house statute applies to drug consumption). 174. see united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019). 175. defendant safehouse's answer, affirmative defenses, counterclaims to plaintiff's complaint, and third-party complaint, supra note 151. 176. see united states v. soto-silva, 129 f.3d 340, 347 (5th cir. 1997). 177. id. at 347. 178. church, 970 f.2d at 405-06; but see united states v. flores-olague, 717 f.3d 526, 531 (7th cir. 2013) (hinting at turning towards the “primary purpose” requirement and relying on united states sentencing guidelines that refer to the crack house statute as not requiring manufacturing or distribution as the sole purpose but as “one of the . . . primary purposes”). 179. supervised consumption services, supra note 55. 180. see, e.g., united states v. shetler, 665 f.3d 1150 (9th cir. 2011) (describing how the crack house statute does not criminalize “simple consumption” in a person’s own home); united states v. russell, 595 f.3d 633 (6th cir. 2010) (adopting a “casual” drug user exception); united states v. lancaster, 968 f.2d 1250 (d.c. cir. 1992). 2021] localism and the opioid crisis 465 becomes under the crack house statute as it might apply to sifs.181 ultimately, judge mchugh arrives at the conclusion that the proscribed purpose under the crack house statute – facilitating drug use – must be a “significant” or “one of the primary” purposes.182 the government in safehouse contended that safehouse’s primary purpose could not be to prevent or reduce drug use since individuals would be using drugs on the premises.183 however, as the government acknowledged, and per safehouse’s own description, safehouse would offer “peer specialists, recovery specialists, social workers, and case managers who will specifically encourage treatment.”184 this, the court concludes, is a program that seeks to reduce drug use rather than facilitate it.185 although safehouse is a private nonprofit corporation, the primary purpose defense could equally serve local government. the primary purpose of a sif is to provide for the critical care of those at risk of drug overdose, the only difference would be that the critical care is being provided by the municipality. but what if local government took the primary purpose defense a step further? what if the marion county prosecutor’s office or the health and hospital corporation of marion county was engaged in the enforcement of this primary purpose – that, pursuant to a municipal ordinance, it required the city or a city agency to make the mitigation of oud a matter of public safety? well, at least one commentator would say there is a possibility that such enforcement could fall under the csa’s little if ever invoked “immunity” clause. but, for reasons outlined below, the immunity clause presents a tenable-at-best defense of a city or county-run sif. 1. a tempting proposition: the controlled substances act’s “immunity” clause professor alex kreit of thomas jefferson school of law writes of the “immunity” clause “buried within the [csa]” at section 885(d).186 the provision provides in part that “no civil or criminal liability shall be imposed . . . upon any duly authorized [f]ederal officer . . . or . . . political subdivision thereof . . . who shall be lawfully engaged in the enforcement of any . . . municipal ordinance relating to controlled substances.”187 at a cursory glance, then, the plain language of the provision seems to support a government-run sif: the local government would enact a law declaring oud an emergency, and provide an ordinance that authorizes sifs to counter that emergency. the employees at the sif would be 181. see generally united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019) (utilizing multiple canons of interpretation, including lengthy legislative history considerations). 182. id. at 607-08 (describing how the government agreed that an “incidental purpose would be insufficient”). 183. id. at 614. 184. id. 185. id. 186. kreit, supra note 168, at 442. 187. 21 u.s.c. § 885(d) (2020). 466 indiana health law review [vol. 18:441 engaged in “enforcing” the local law. but a plain language analysis might only get us so far. while the crack house statute has been somewhat litigated at the appellate level, there is little case law surrounding section 885(d), and most cases involve undercover officers – or what kreit calls “rogue” government officials.188 despite the limited legislative history regarding the clause, kreit and others suggest that it was probably included to provide immunity for undercover officers who may, as part of their official duty, be tasked with handling illegal drugs.189 that the provision applies to undercover officers certainly aligns with the word “enforcement” as it is commonly understood; black’s law dictionary defines enforcement as “the act or process of compelling compliance with a law.”190 but where is the compulsion in the case of sifs? to be sure, government employees at county-run sifs would not be compelling the compliance with the ordinance, they would simply be carrying out the provisions of that ordinance. but kreit ambitiously suggests a more expansive definition of “enforcement”: that it may also mean, as the united states supreme court noted in merrill lynch v. manning, to “give force [or] effect to.”191 true, some courts have accepted that “enforce” (rather than “enforcement”) encompasses more than just the compulsory aspect. for instance, the eighth circuit has accepted the united states supreme court’s definition.192 other courts, including at least the d.c. and tenth circuits, have similarly adopted this definition.193 so, the “immunity” clause seems tempting: city or county workers at a sif would be “enforcing” a health-and-safety directive under local law and therefore would be covered by section 855(d). but section 855(d) does not enjoy the same breadth of legislative history nor the guidance of robustly litigated terms and provisions like the crack house statute. judge mchugh was receptive to the “primary purpose” defense in part because it was not created out of the whole cloth; it was thoughtfully patterned using existing circuit precedent.194 so, while it might be tempting to rely on 188. kreit, supra note 168, at 443; see also united states v. wright, 634 f.3d 770 (5th cir. 2011) (holding that the defendant deputy sheriff was not entitled to a section 885(d) defense when attempting to possess cocaine); united states v. fuller, 162 f.3d 256 (4th cir. 1998) (rejecting the defendant mayor’s “under-cover drug operations” via a section 885(d) defense on the distribution of crack cocaine charges). 189. see kreit, supra note 168, at 443. 190. see enforcement, black’s law dictionary (11th ed. 2019). 191. kreit, supra note 168, at 451 (quoting merrill lynch v. manning, 136 s. ct. 1562, 1569 (2016)). 192. mcghee v. pottawattamie cty., iowa, 547 f.3d 922, 931 (8th cir. 2008) (recognizing that “enforce . . . must mean something other than to ‘prosecute’”). 193. see bellagio, l.l.c. v. nlrb, 863 f.3d 839, 848 (d.c. cir. 2017); greenbaum v. bailey, 781 f.3d 1240, 1244 (10th cir. 2015); k.p. v. leblanc, 627 f.3d 115, 127 (5th cir. 2010) (dennis, j., concurring) (asserting that a “conception of ‘enforcement’ as involving compulsion or constraint seems . . . unnecessarily restrictive”). 194. united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019) (relying on the fifth 2021] localism and the opioid crisis 467 section 855(d) as a magic key – there is certainly more than one reasonable resolution of the word “enforcement” – a city or county acting unilaterally would be on extraordinarily weak footing considering the case law surrounding the provision. anyone urging an expansive reading of section 885(d) would face an uphill battle of dictionary definitions and unhelpful case law. 2. time is a safer bet than section 885(d) of course, if there were a state law permitting “enforcement” of a local health-and-safety regulation that requires life-saving drug prevention resources, a sif might start to look more like a police power health-and-safety “enforcement” action. that is certainly true in the case of seps: the indiana sep statute authorizes counties to unilaterally declare a public health emergency in order to implement a sep.195 but seps are, at least to some degree, now accepted at the federal level.196 this is due, in large part, to the hiv/aids epidemic during the early to mid-1990s: the harm reduction research being done by private foundations eventually culminated in the secretary of hhs acknowledging the efficacy of seps.197 the same is true of indiana: it was the dual opioid/hiv epidemic in scott county that led to seps being endorsed by the politicians that once found them objectionable.198 but the future of seps in indiana is uncertain.199 attempts to remove the sunset date were unsuccessful.200 yet, the behind-the-scenes action looks hopeful: although senate bill 207 (the bill that would eliminate the sunset provision) died, support continues to grow: indiana senator michael crider, a republican from greenfield, has said that he does not like seps but “based on what [he] know[s], there is no way [he could] vote against a bill like” senate bill 207.201 this constantly mounting support for seps in indiana is a stark contrast to the beliefs held previously by indiana public officials: seps were banned in the state before the hiv outbreak in 2015.202 indeed, it was so morally difficult for circuit’s and seventh circuit’s definitions of “purpose” as proscribed by statute). 195. ind. code § 16-41-7.5-4 (2021). 196. see, e.g., 42 u.s.c. § 300ee-5 (2020) (authorizing, in limited instances, the use of federal funds for needle exchange programs that “would be effective in reducing drug abuse”). 197. see don c. des jarlais, harm reduction in the usa: the research perspective and an archive to david purchase, 14 harm reduction j. 51 (2020). 198. victoria knight, needle exchanges find new champions among republicans, kaiser health news (may 9, 2019), https://khn.org/news/needle-exchanges-find-new-champions-amongrepublicans/, [https://perma.cc/269d-k6w8]. 199. see ind. code § 16-41-7.5-14 (2021). 200. s.b. 207, 121st gen. assemb., 1st reg. sess. (ind. 2020). 201. whitney downard, syringe service program bill dies in indiana senate, ind. econ. dig. (feb. 5, 2020), https://indianaeconomicdigest.net/content/default/major-indiana-news/article/span-style-font-weight-bold-syringe-service-program-span-bill-dies-in-indiana-senate/3/5308/98745?s=1 [https://perma.cc/n6q2-cd6r]. 202. see jake harper, indiana’s hiv outbreak leads to reversal on needle exchanges, npr 468 indiana health law review [vol. 18:441 then-governor mike pence to approve a sep in scott county in the midst of the hiv outbreak that he had to “pray on it.”203 and, of course, it is a difficult decision, balancing one’s deeply held convictions against “ground-level reality.”204 but that is precisely what is hopeful about this scenario: changing sentiment regarding once-controversial harm reduction measures gives way in the face of such “ground-level realities” as the opioid epidemic. time, as has been proven in indiana’s case, seems like a much more useful tool than a strained reading of section 885(d). but do we have time? indeed, “hurry up and wait” seems like cold comfort in the face of such a pressing problem. of course, litigants would want to assert the “enforcement” defense, it is just likely not the winning option. but what would sifs – and to some extent, continuing seps – look like in indiana, right now? how would the judiciary react to the “primary purpose” defense? c. primary purpose and indiana’s home rule act the primary purpose defense that served safehouse well thus-far in its battle with the doj is well-outlined in its memorandum.205 it is a potentially valuable source of legal theory on how to develop a possible defense to a doj challenge to a city or county-run sif. further, the doj’s motion for summary judgment provides telling insight on how the doj might continue to prosecute such facilities.206 since the “primary purpose” defense, as it relates to the csa, has been discussed previously in this note, and because the case is on appeal, vigorous briefing by both sides is sure to follow.207 as such, i will not belabor it much here. more importantly though, for purposes of this note, is the “primary purpose” defense in the context of indiana’s syringe possession law’s intent requirement. section 16-42-19-18 requires that the defendant have the specific intent to use an “instrument adapted [for the] use of narcotics” in an illegal manner.208 illegal manner means the “intent to violate the indiana legend drug act.”209 the indiana (june 2, 2015), https://www.npr.org/sections/health-shots/2015/06/02/411231157/indianas-hivoutbreak-leads-to-reversal-on-needle-exchanges [https://perma.cc/sl6z-dd83]. 203. megan twohey, mike pence’s response to h.i.v. outbreak: prayer, then a change of heart, n.y. times (aug. 7, 2016), https://www.nytimes.com/2016/08/08/us/politics/mike-penceneedle-exchanges-indiana.html [https://perma.cc/7yl7-8gkn]. 204. id. 205. see safehouse's memorandum of law in opposition to the department of justice's motion for judgment on the pleadings at 1-6, united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019) (no. 2:19-cv-00519), 2019 wl 6704500. 206. united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019). 207. see the united states’ motion for summary judgment and opposition to safehouse’s motion for declaratory judgment at 1-2, united states v. safehouse, 408 f. supp. 3d 583 (e.d. pa. 2019) (no. 19-0519), 2020 wl 562321. 208. see cooper v. state, 357 n.e.2d 260, 265 (ind. ct. app. 1976). 209. see id. at 264. 2021] localism and the opioid crisis 469 legend drug act (“ilda”) prohibits “possess[ion] or use [of] a legend drug.”210 if the enabling county or the facilitators of the sif or sep were charged under the syringe possession statute, they would not have the requisite intent under the syringe possession statute because neither the county nor the staff of the sif or sep would have the intent to use the syringe for the purpose of using a legend drug under the ilda. neither the county nor the facilitators would be using any drugs. so, enabling statute or not, the outcome is the same for both the county as well as the employees – they simply do not have the intent to possess or use a legend drug. to be sure, it would almost certainly be the intent of a participant in the program to use a legend drug with a syringe obtained through a sep. and, of course, a participant at a sif would be in possession of a legend drug as proscribed by the ilda and using the syringe to inject a legend drug at the facility itself. but, especially in the case of seps, there is no meaningful difference in the legality of the participant defendant’s actions: under current indiana case law, a defendant who participates in such programs can still be charged and convicted under the statute.211 so, the outcome, in terms of criminality, theoretically, remains the same for both the participant and the operator, statutory authority or not. unquestionably, though, the local enabling body would need to gain the consensus of both the community and law enforcement in order to give any meaningful effect to a city or county-run sif or sep. viii. conclusion while indiana has made strides in combatting oud, there exist fundamental differences between state and local interests. moreover, as cities and counties are more uniquely positioned to address a problem such as oud, they can more effectively implement harm reduction strategies. although such entities are at the creation of the state, indiana localities enjoy some level of local autonomy in providing for matters that are uniquely local in character. if indiana cities and counties want to see a continued reduction in casualties by oud, then they should use all the tools at their disposal. two of these tools are sifs and seps. despite state and federal concerns, an indiana city or county, under the home rule act’s authority – and a clever reframing of critical issues – may put forth a tenable legal claim to be able to operate a municipal sif or sep. although both the indiana and federal governments have expressed increasing reluctance to accept the efficacy sifs, and the future of seps in indiana remains uncertain, the question remains: how will this reluctance look in practice and what can indiana cities and counties do to prepare for the challenge? 210. ind. code § 16-42-19-13 (2021). 211. leatherman v. state, 101 n.e.3d 879, 886 (ind. ct. app. 2018). 470 indiana health law review [vol. 18:441 the only way to know for sure is to build a local consensus and bolster the city or county for the legal challenges to come – or be hamstrung to waiting for a seachange in public and political sentiment. so, perhaps a better question to ask is, as kassandra frederique of drug policy alliance puts it, “why [do we] we keep asking . . . law enforcement officials what are appropriate interventions in a health crisis?”212 212. gullapalli, supra note 72. the safe harbor of 35 u.s.c. § 271(e)(1): the costly confusion about the scope of “patented invention” abraham phillips* i. introduction a. the problem to be solved a patent in the united states conveys an exclusive right over an invention for a limited term,1 often about seventeen years.2 during this interval, the patent holder has the right to stop others from making, using, selling, importing, or offering to sell the claimed invention in the united states.3 this power to exclude had a compounded effect for drug and medical device inventions requiring u.s. food and drug administration (“fda”) approval prior to market entry. stopping a future competitor from using an fda-regulated invention throughout the entire patent term also prohibited the competitor from beginning the fda approval process until the patent expired. quantitatively, this extended the legal monopoly of the patent holder by between one-and-a-half to six years for the competitor’s clinical trials alone.4 meanwhile, the invention owner’s path to fda approval for a regulated drug or medical device was often not without a symmetric grievance. the patent holder commonly obtained fda approval long after their original patent filing date–the date which started the clock on the twenty-year term. accordingly, the inventor waited several years for fda approval to sell the regulated invention, thereby shortening the effective patent term. unsurprisingly, a patent holder’s enjoyment of no competition while a generic sought fda approval was often deemed warranted by the patent holder’s own “regulatory entanglements” on the front end of selling a patented drug.5 while this rationale may reek of the unsatisfying fallacy that “two wrongs make a right,” it nevertheless prevailed during legislative silence. resolving this symmetric distortion is a subject courts and legislatures have wrestled with for decades. * j.d. candidate, 2023, indiana university– robert h. mckinney school of law; b.s., 2013, university of illinois, urbana-champaign. 1. 35 u.s.c. § 154(a)(2) (2013). the exact term of exclusionary rights over a patented invention begins on the day the associated patent issues and terminates twenty years from its earliest application’s filing date. 2. id. the interval over which an inventor may enforce a patent is often around seventeen years because patents often grant two to three years after their earliest filing date. 3. 35 u.s.c. § 154(a)(1) (2013). 4. step 3: clinical research, u.s. food & drug admin., https://www.fda.gov/patients/ drug-development-process/step-3-clinical-research [https://perma.cc/z76b-nzel] (last updated jan. 4, 2018) (clinical trials are generally the longest phase of fda approval). 5. roche products, inc. v. bolar pharm. co., 733 f.2d 858, 864 (fed. cir. 1984) (prior to §156 of the hatch-waxman act, the filing date started the patent term clock even though the drug was not approved by the fda and could not be sold). 144 indiana health law review [vol. 20:143 b. executive summary to understand current problems with the statutory solution to patent term distortions arising from fda approval, this note begins with describing the judicial tool most promising to resolve the most contentious distortion–an “experimental use exemption” to patent infringement granted under certain circumstances.6 after explaining how the experimental use exemption ultimately failed to provide satisfactory results, the note introduces the responsive legislative solution–the hatch-waxman act (“act”). the note then assesses the language of the act and unfolds the case law developing its most litigated terms. after criticizing the act’s use of undefined statutory terms–which do not secure a preferable symmetry between complementary sections of the act–the note explains how courts now disagree, at least in part, on the scope of what inventions are shielded from patent infringement claims. after suggesting a legislative amendment to the act, the note then focuses on a certain class of inventions commonly known as research tools. these inventions are not themselves subject to fda approval–though they are consistently used in obtaining fda approval for other products. research tools are abundant in a laboratory and include at least mechanical, biochemical, biological, and chemical articles. this note exposes uncertainty in the status of these tools under the act and illustrates continued uncertainty after the judiciary’s failed attempt to clarify. the note also briefly assesses the general consequence of this ambiguity. the note then illustrates the detrimental effect this uncertainty is having on predictability of litigation by examining two cases, filed on the same day, in different jurisdictions. the cases have materially equivalent facts–the same plaintiff suing for patent infringement based on a similar use of the same patented research tool. while one case has now settled, the jurisdictions still have conflicting precedent on the precise issue which may prove dispositive in future litigation. the note concludes by proposing the judiciary adopt a bright-line rule excluding research tools from the purview of the act’s safe harbor. though legislative action would be preferable, this note maintains it is not required for a clear interpretation of the statute. importantly, the judiciary need not fear entering the legislative realm to clarify the uncertainty–and it is in fact the judiciary’s duty. rather, for the judiciary to remain silent while a well-defined industry is subject to unpredictable liability, arising from everyday business decisions, may constitute a dereliction of duty. c. from the experimental use doctrine to a statute sprouting from a germinate sentence written by justice story in 1813, the common law exemption against patent infringement grew into the experimental 6. moore u.s.a., inc. v. standard reg., 144 f. supp. 2d 188, 196 (w.d.n.y. 2001). 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 145 use doctrine.7 justice story recognized a sort of honor in curiosity without monetary gain and thought it was incompatible with the patent laws to punish a purely inquisitive mind.8 with a subtle boldness, story asserted “it could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.”9 this became known as the common law exemption to patent infringement. forty-eight years later this doctrine stated that an “experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or for mere amusement” is not patent infringement–considerably close to justice story’s own description.10 in fact, the doctrine departed from its origins for over a century. gradually, in applying this doctrine, a distinction resulted in the emergence of two branches of thought within cases. the broadest view maintained experimental use defenses to patent infringement could be honored even when the use was for business purposes–as long as the product was not sold or intended for sale.11 the public policy rationale was to allow competitors to seek improvements upon another’s invention without liability and, in theory, accelerate innovation.12 the narrower view held the experimental use exemption was to be forfeited as a defense if the patented product was used “in keeping with a legitimate business of the using agency.13 thus, courts were divided on whether the experimental use exemption could be used as a means of shielding oneself from liability while actively advancing a business interest. in a fundamental sense, this conceptual divide over public policy and the role of patents is still present today. in 1984, the broader branch of case law invited a generic drug manufacturer to offer the experimental use doctrine as a defense against patent infringement.14 in roche products v. bolar pharmaceuticals, the generic manufacturer used a patented drug–prior to the patent’s expiration–in seeking its fda approval.15 bolar pharmaceuticals had imported the patented substance to assess parameters required by the fda to prove bioequivalence, thus ensuring the generic version 7. whittemore v. cutter, 29 fed. cas. 1120, 1121 (c.c.d. mass. 1813). 8. id. 9. id. 10. poppenhusen v. falke, 19 fed. cas. 1048, 1049 (c.c.s.d.n.y. 1861). 11. see chesterfield v. united states, 159 f. supp. 371, 375 (ct. cl. 1958) (experimentation with patented steel alloys excused under experimental use inter alia because no evidence suggested the manufacture sold or intended it for sale); dugan v. lear avia, 55 f. supp. 223 (s.d.n.y. 1944), aff'd sub nom. dugan v. lear, inc., 156 f.2d 29 (2d cir. 1946) (building of a patented device was protected from infringement because, though it was built by a business, it was not sold or intended for sale); akro agate co. v. master marble co., 18 f. supp. 305 (n.d.w. va. 1937) (making and using a patented product was protected from infringement because, though it was made and confirmed to work with production equipment, it was not commercially sold). 12. dugan v. lear avia, 55 f. supp. 223, 228 (s.d.n.y. 1944). 13. pitcairn v. united states, 547 f.2d 1106, 1125-26 (ct. cl. 1976). 14. roche products, inc., 733 f.2d at 862. 15. id. at 860. 146 indiana health law review [vol. 20:143 would be market-ready soon after roche’s patent expired.16 in an unusually forceful opinion, the newly minted17 federal circuit declined to extend the experimental use doctrine to protect generics seeking fda approval, emphasizing the doctrine was ill-fitted for the circumstances and that the federal circuit was not authorized to rewrite patent law.18 thus, while generic drug manufacturers once offered the experimental use exemption with a flicker of hope that it might protect their pursuit of fda approval in advance of patent expiration, the roche court formally snuffed out exactly that wish. in its stated refusal to act in a legislative manner,19 the roche court deliberately highlighted the strong public policy rationale for an exemption. the public welfare, in the form of affordable drug prices, depends on price competition as much as protecting the right to profit from a large investment.20 without the former, fewer can afford the drugs produced; without the latter, the drugs may never be developed at all. even so, the court noted the strength of any public policy rationale as immaterial to their task–naming the legislature as the proper forum for such a debate and referencing pending legislation on the very issue.21 the roche opinion has been interpreted as a “very narrow” experimental use exemption.22 the often-quoted standard from roche holds the exemption is limited to actions performed “for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry”– a hermetically sealed version of the poppenhusen wording from the mid-nineteenth century.23 within months of the roche decision, the drug price competition and patent term restoration act (“the act” or “the hatch-waxman act”) was signed into law in september of 1984.24 as designed, § 271(e)(1) of the hatch-waxman act, 16. id. 17. u.s. ct. of app. for the fed. cir., https://cafc.uscourts.gov/home/the-court/about-thecourt/ [ https://perma.cc/tu97-7d48] (last visited dec. 17, 2022) (the federal circuit formed as an article iii court on october 1, 1982, by the merging of the united states court of customs and patent appeals and the appellate division of the united states court of claims). 18. roche products, inc., 733 f.2d at 862-65 (the federal circuit flags the expansive view of experimental use shielding “experiment” as “obiter dictum” and refuses to “rewrite the patent laws”). 19. id. at 863-64 (“parties. . .seem to think. . .we must resolve a conflict between the federal food, drug, and cosmetic act. . .and the patent act[.] we decline the opportunity here, however, to engage in legislative activity proper only for the congress.”). 20. id. at 865. 21. id. (the federal circuit emphasized the fact congress was actively debating the drug price competition act of 1983). 22. madey v. duke university, 307 f.3d 1351, 1362 (fed. cir. 2002). 23. roche products, inc., 733 f.2d at 863; see also madey, 307 f.3d at 1362 (quoting embrex, inc. v. serv. eng’g corp., 216 f.3d 1343 (fed. cir. 2000)) (consistent reliance on roche’s language). 24. president's remarks on signing the drug price competition and patent term restoration act of 1984 at the white house, washington d.c., 20 pub. papers 39 (sept. 24, 1984) (ronald reagan signed the hatch-waxman act into law on september 24, 1984). 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 147 commonly referred to as the “safe harbor” provision, successfully allows a generic drug manufacturer to use a patented drug prior to patent expiration when generating data for fda submission: it shall not be an act of infringement to make, use, offer to sell, or sell within the united states or import into the united states a patented invention . . . solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.25 when construing the terms of the statute above, it is interesting to consider the judicial interpretation of its sister statute – § 156, relating to extension of a patent term–also part of the hatch-waxman act.26 in addition to providing a remedy for generics being delayed in market entry, the hatch-waxman legislation also sought to remedy the symmetric distortion on the effective start date of a patent term.27 as introduced above, the patent term would often begin before the fda had approved the drug for use–reducing the profitable term of the patent on its front end.28 this reduction in profitable term was not only unpredictable, but out of the inventor’s control while the data was with the fda for review and approval. under § 156 of the 1984 hatch-waxman legislation, an original drug manufacture can receive a patent term extension if the patent term is triggered prior to receiving regulatory approval.29 the exact extension is calculated according to the statute.30 importantly, this provision is codified using the term “product,” to describe those items falling within its ambit.31 indeed, the statute explicitly defines “product” to refer to “[a]ny medical device, food additive, or color additive subject to regulation under the federal food, drug, and cosmetic act.”32 in an unsuspected contrast, and despite the symmetry in function, § 271(e)(1) uses “patented invention” to describe articles within its scope and is internally silent on defining the term.33 while plot twists are amusing at the cinema, they are good for nothing but a law review article when spotted in legislation. 25. 35 u.s.c. § 271(e)(1) (2015). 26. 35 u.s.c. § 156(c) (2015). 27. id. 28. proveris sci. corp. v. innovasystems, inc., 536 f.3d 1256, 1261 (fed. cir. 2008). 29. 35 u.s.c. § 156(c) (2015). 30. id. 31. § 156(a). 32. § 156(f). 33. 35 u.s.c. § 271 (2015). 148 indiana health law review [vol. 20:143 ii. background: the status of judicial interpretation a. a tale of two terms though the legislative act prevented extending a patent monopoly during the delay of fda approval, it has not alleviated the judiciary’s interpretive role. litigation over the statutory scope of both applicable subject matter and activity has been frequent. two terms of § 271(e)(1) have received the most attention: the scope of “patented invention,” as alluded to above; and the scope of “reasonably related.”34 debate concerning the former term seeks to characterize eligible inventions by several criteria, which will be explored below, and debate concerning the latter seeks to characterize what fda approval activity the statute intended to protect. b. reasonably related naturally, a ‘reasonableness’ standard left ripe for judicial interpretation results in substantial case law. this case law has shaped the outer boundaries of the exemptions of § 271(e)(1), but the exact contours form only a blurry line. where § 156 offered tidy definitions to assist in assessing its reach, § 271(e)(1) has instead relied on the generation of a sizable body of case law.35 1. expansive scope what is “reasonably related” to fda approval is perhaps the best understood, and the least consequential, of the two terms. reasonably related activity has been held to include: early experimentation where some or even all information may never be submitted to the fda;36 experimentation with a patented peptide in hopes of success and eventual fda submissions for an investigational new drug (“ind”) application;37 use of data from clinical study for purposes other than fda submissions; and activities targeting revision of a drug label.38 further, the protection of the safe harbor extends to drug production runs for qualification of processes and equipment under a federal regulation.39 however, designating some of the resulting product from a qualification run as “commercial inventory,” though not decisive, risks forfeiture of the safe harbor.40 the supreme court case of merck, which considered early experimentation, is generally regarded as an inflection point solidifying an expansive view of “reasonably related.”41 merck 34. § 271(e)(1). 35. 35 u.s.c. § 156(f) (2015). 36. merck kgaa v. integra lifesciences i, ltd., 545 u.s. 193, 206 (2005). 37. integra lifesciences i, ltd. v. merck kgaa, 496 f.3d 1334, 1341 (fed. cir. 2007). 38. classen immunotherapies, inc. v. elan pharm., inc., 786 f.3d 892, 899 (fed. cir. 2015). 39. amgen, inc. v. hospira, inc., 944 f.3d 1327, 1339-40 (fed. cir. 2019). 40. id. at 1340 (two batches designated as “commercial inventory,” one was shielded, and the other was not). 41. daniel wobbekind, integra lifesciences i, ltd. v. merck kgaa: re-examining the broad 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 149 will be unfolded later in this note with focus on how its broad language has an inevitable influence on the scope of the patented invention. 2. not routine one judicial limitation on what constitutes “reasonably related” under the safe harbor looks at the type of submission which might be generated from the activity.42 specifically, courts distinguish between activity resulting in “routine” and “not routine” submissions to the fda.43 though both types of activities may be related to obtaining or maintaining fda approval, only activities which are deemed “not routine” are eligible for shielding under the safe harbor.44 while this requirement receives particular attention with post-approval activity, its waiver should not be assumed simply because a product has not yet received fda approval. such an absolute rule might encourage gamesmanship on the part of the manufacturer. for example, production of commercial product prior to fdaapproval would be disallowed afterward while the controlling patent is still in force. accordingly, the court has allowed discretion on this matter and referred to the american heritage dictionary to define “routine” as an activity which is “habitual” or “regular.”45 hence, the word “reasonable” does not merely convey a degree of relatedness but also a second qualifying quality concerning the activity’s output. so, factual relatedness, though necessary, is not alone sufficient to satisfy “reasonably related.” the activity must also be non-routine. as for sample submissions, which do not rise above routine, the federal circuit has clarified among them are some activities, which are continued throughout market availability –such as quality control processes and reporting adverse effects of a vaccine when administered according to a patented low-risk method.46 in contrast, protected ”non-routine” fda reporting has been held to include: (1) submissions to revise a drug label;47 (2) experimentation which has the potential to result in an fda submission;48 and (3) preparation for a mandatory fda pre-approval inspection.49 from a theoretical viewpoint, two characteristics are often used to signify routine. first, as introduced above, the “regularity” of a submission–especially one which would continue throughout market availability–supports the “routineness” of the activity used to generate the submission.50 second, an activity must scope of the s 271(e)(1) safe harbor, 23 berkeley tech. l.j. 107, 138 (2008). 42. id. at 1338. 43. integra lifesciences i, ltd. v. merck kgaa, 496 f.3d 1334, 1343 (fed. cir. 2007). 44. momenta pharm., inc. v. amphastar pharm., inc., 686 f.3d 1348, 1358 (fed. cir. 2012). 45. momenta pharm., inc. v. teva pharm. u.s.a., inc., 809 f.3d 610, 620 (fed. cir. 2015). 46. classen immunotherapies, inc. v. biogen idec, 659 f.3d 1057, 1072 (fed. cir. 2011); see also momenta pharm, 809 f.3d at 618. 47. elan pharms, 786 f.3d at 898. 48. integra lifesciences i, ltd. v. merck kgaa, 496 f.3d 1334, 1340-48 (fed. cir. 2007). 49. amgen, 944 f.3d at 1339-44. 50. momenta pharm, 809 f.3d at 620. 150 indiana health law review [vol. 20:143 produce submissions presently required to obtain fda approval – not merely maintain fda approval – for it to succeed at overcoming the bar against routine submissions.51 the federal circuit’s use of legislative history affirms this as a minimum.52 in short, if the alleged infringing activity produces a submission type which continues during market availability, the activity is likely routine, and use of the associated patented invention will likely not be shielded. b. patented invention not surprisingly, the generic term “patented invention” of § 271(e)(1) of the hatch-waxman act invariably includes – at the very least53 – the use of a drug when that use is “reasonably related” to obtaining fda approval on that same drug.54 in bounding that scope, the statutory language identifies no obvious limitation to the statute’s patented invention. indeed, § 271 uses “patented invention” throughout to refer to all inventions without regard for their status under federal regulations or otherwise.55 it is not clear whether the patented invention shielded must be used in connection with its own fda approval. further, it is not clear whether the patented invention must be subject to fda approval at all. by comparison, while the common law exception has the reach of t-rex arms, the act is linguistically poised with the reach of an orangutang gliding through the treetops. even so, courts have defined “patented invention” with some particularity.56 while courts agree the term is not limited to pharmaceutical drugs, a close look reveals courts disagree on whether the patented invention’s regulatory status under the fda is required. 1. not all about drugs first, the supreme court in eli lilly v. medtronic clarified that “patented invention” includes “all inventions, not drug related inventions alone.”57 unsurprisingly, it is settled that the statute shields the use of patented processes, pharmaceutical manufacturing equipment, medical devices, and pharmaceuticals from infringement when used to approve those technologies under their respective fda regulations.58 this holding aligns with the intent to ensure a competitor can introduce a generic product to market immediately upon patent expiration. notably, the statement in eli lilly is made without caveat and has 51. integra lifesciences i, 496 f.3d at 1343. 52. biogen idec, 659 f.3d at 1071 (quoting h.r. rep. no. 98-857(i) at 45 (1984)). 53. proveris sci., 536 f.3d at 1263. 54. 35 u.s.c. § 271(e)(1) (2015) (to the author’s knowledge, no case has excluded drugs subject to fda approval from the statutory reach of “patented invention”). 55. id. 56. id. 57. eli lilly & co. v. medtronic, inc., 496 u.s. 661, 665 (1990). 58. see amgen inc., 944 f.3d at 1338-40; elan pharm., inc., 786 f.3d at 898; proveris sci., 536 f.3d at 1262. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 151 occasionally been read to suggest a contrast to the “product” of § 156, calling into question whether the “patented invention” must itself be subject to fda approval.59 2. invention’s status under regulation following eli lilly, the next seeming expansion in the scope of what the “patented invention” includes came from the federal circuit. in abtox v. exitron, a defendant used a plasma sterilizer–not itself subject to § 156 or full fda approval60, and was granted summary judgement for non-infringement on its motion to dismiss.61 the abtox court reasoned the supreme court in eli lilly had only indicated statutory symmetry between §156 and § 271 was “preferable but not required.”62 hence, according to the abtox court’s interpretation, the “products” of § 156 need not refer to the same class of inventions as the “patented invention” of § 271–presumably, § 271 including a broader class.63 then, in 2005, the supreme court subtly weighed in on the subject in merck v. integra lifesciences.64 though, merck is often understood to turn on the “reasonably related” term, as discussed above, there is an aspect of merck’s holding which is inextricable from the scope of a “patented invention.”65 as an observational matter, a patented compound in the preclinical “twilight zone”–having only hopes of proving therapeutic–is not yet, at the time of experimentation, subject to fda approval. merck held such a patented compound, not yet subject to fda approval, was within the ambit of the safe harbor.66 public policy motivation for this outcome is centered on encouraging experimentation with potentially useful, but patented compounds. questions remain whether this holding unacceptably erodes eli lilly’s preference for statutory symmetry. 3. the standing of the research tool while merck may have been written with the defining of “reasonably related” in mind, it would appear the reader was struck with its profound effect on the “patented invention” term. specifically, merck held that the safe harbor is not necessarily forfeited when there is “use of patented compounds in experiments 59. merck kgaa, 545 u.s. at 208 n.7. 60. abtox, inc. v. exitron corp., 122 f.3d 1019, 1029 (fed. cir. 1997) (held the sterilizer was a class ii device not eligible for a patent term extension under § 156 because of its status as subject to an abbreviated fda approval process). 61. id. 62. id. 63. abtox, 122 f.3d at 1027. 64. merck kgaa v. integra lifesciences i, ltd., 545 u.s. 193 (2005). 65. id. 66. see merck kgaa, 545 u.s. at 206. 152 indiana health law review [vol. 20:143 that are not ultimately submitted to the fda.”67 further, merck interprets eli lilly to hold § 271(e)(1) “exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs.”68 it is not hard to spot the implications while reading with the court’s own emphasis. the patented compounds being used are not necessarily the same compounds receiving, or subject to, the referenced fda approval. merck’s broad view of § 271(e)(1) provoked a slew of articles warning the demise of laboratory research tool development under the swelling safe harbor of § 271(e)(1).69 anchored in policy animating u.s. patent law, these critical publications argued limited patent enforcement for research tool disclosures would result in fewer patents being made public, less progress in the art by advancements thereupon, and a reduction in related capital investment.70 seventeen years later, questions remain whether merck issued an “open season” on the unlicensed use of patented research tools. it is difficult to say to what extent these fears came to pass. without a control group (against which a meaningful change could be observed) or a dramatic change in the generation of research tool technology, we can only tentatively say the effects appear to have been minimal across the research tool industry. in contrast, a noticeable effect certainly arose among the courts. a minority of cases have in fact used this language from the supreme court in merck to disassociate the submission of fda approval from the patented invention.71 specifically, the safe harbor has been used to protect the use of a patented invention for the generation of data to be submitted pursuant to the fda approval of a second article.72 for example, in the 2013 case of teva pharms. v. sandoz, the u.s. district court for the southern district of new york extended the safe harbor to patented polypeptide markers used to obtain molecular weight characteristics of 67. id. 68. id. 69. see wolrad prinz, research tool patents after integra v. merck have they reached a safe harbor?, 14 mich. telecomm. & tech. l. rev. 367, 445 (2008); see also tara stuart, has the supreme court incorrectly expanded s 271(e)(1) to risk a regulatory taking?, 5 j. marshall rev. intell. prop. l. 216, 237 (2006); joshua d. sarnoff & christopher m. holman, recent developments affecting the enforcement, procurement, and licensing of research tool patents, 23 berkeley tech. l.j. 1299, 1365 (2008). 70. see generally daniel wobbekind, integra lifesciences i, ltd. v. merck kgaa: reexamining the broad scope of the s 271(e)(1) safe harbor, 23 berkeley tech. l.j. 107, 138 (2008) (arguing funds for research will be stifled without patent enforceability); brendan m. o'malley, merck v. integra and its aftermath: a safe harbor for the commercial use of biotechnology research tools?, 23 cardozo arts & ent. l. j. 739, 760 (2006) (arguing an immediate financial impact to researchers and long-term impact on public welfare). 71. see teva pharms. usa, inc. v. sandoz inc., no. 09 civ. 10112, 2013 wl 3732867 (s.d.n.y. july 16, 2013). 72. id. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 153 an active ingredient in a drug.73 the shielded markers are not a drug nor subject to fda approval.74 specifically, these markers are only used to extract data from the marketable drug, data which is then submitted to the fda for approval of the marketable drug.75 hence, the polypeptide markers fall squarely within the research tool class of inventions. though the merck court explicitly declined to address the issue of research tools,76 the merck holding was used in deciding the sandoz case which involved research tools.77 the supreme court’s refusal to acknowledge research tools as a distinct class has perhaps inadvertently brought them under the broad principles above and did not foreclose the use of merck in that context. 4. narrowing at the federal circuit perhaps in response to a recognized need, or echoing concern for research tool patents, eighteen years after eli lilly, and three years after merck, the federal circuit seemingly carved out a limitation on the statutory “patented invention.” in proveris v. innovasystems, the federal circuit held that the use of innova’s laboratory equipment–not itself subject to fda approval, but used exclusively in producing data for fda approval–was not shielded by the safe harbor of § 271(e)(1).78 the federal circuit reasoned that since excluding innovasystems from use of the patented device would not unfairly extend the life of the patent by an approval delay, the purpose of the safe harbor would not be served in applying it in that instance.79 the federal circuit explains this in plain terms: innova is not a party seeking fda approval for a product in order to enter the market to compete with patentees. because the osa device is not subject to fda premarket approval, and therefore faces no regulatory barriers to market entry upon patent expiration, innova is not a party who, prior to enactment of the hatch-waxman act, could be said to have been adversely affected by the second distortion. for this reason, we do not think congress could have intended that the safe harbor of § 271(e)(1) apply to it.80 in this excerpt, the proveris court underscores key rationale and issues a single result in harmony with this note’s call for a bright-line rule. this decision strengthened the case for a general rule excluding patented inventions not subject to fda approval from the safe harbor. however, sandoz–decided about five 73. sandoz, 2013 wl 3732867, at *1. 74. id. at *2. 75. id. 76. merck kgaa, 545 u.s. at 205 n.7. 77. sandoz, 2013 wl 3732867, at *8. 78. proveris sci. corp., 536 f.3d at 1266. 79. id. at 1265. 80. id. 154 indiana health law review [vol. 20:143 years after proveris–has not been recognized as establishing a binding rule.81 it would appear this is because of the supreme court’s unwillingness to concur on such a categorical limitation. in the face of such binding federal circuit guidance, how did sandoz justify a dismissal of patent infringement for use of the patented polypeptide marker? surprisingly, sandoz does not interpret proveris to narrow, or even consciously impact, the statutory “patented invention.”82 instead, sandoz emphasizes proveris’s reliance on the statute’s requirement that activity is “solely for uses” related to fda approval.83 sandoz points out that in proveris, the defendant was “manufacturing and selling a patented device” and argued their “customers’ activities”–being in connection with seeking fda approval–were a basis to grant the defendant shelter under the safe harbor.84 the defendant wanted to sell a patented product to a customer who would use it in connection with fda approval.85 accordingly, had the defendant in proveris been the one using the patented invention, according to sandoz at least, the safe harbor may very well have applied.86 to clarify, sandoz expressly concludes that to read proveris to hold that laboratory equipment forms a class of devices generally unprotected by the safe harbor would be to “read proveris too narrowly.”87 in sandoz’s view, proveris did not exclude laboratory equipment, a subset of research tools, from the reach of the safe harbor, but rather, the use of a patented invention where the user was not seeking fda approval.88 to construct proveris so narrowly is, in this author’s opinion, to corrupt the context and conflate the audience with the actors. regrettably, whether fda approval was sought concerning the patented invention was left optional. d. summary of uncertainty concerning research tools today, all these factors have produced uncertainty concerning the safe harbor’s effect on the species of patented invention, commonly referred to as research tools.89 generally, research tools are not subject to fda approval, though they are often required to generate data demanded by fda submissions. sandoz is a district court decision in which a research tool was brought under the safe harbor, but sandoz is in the minority on this holding.90 proveris, on the other 81. sandoz, 2013 wl 3732867, at *8. 82. id. at *7. 83. id. at *8. 84. id. 85. id. 86. id. 87. id. 88. id. 89. merck kgaa, 545 u.s. at 208 n.7. 90. to this author’s knowledge, sandoz is the only district court which has explicitly included in the scope of “patented invention” drugs not themselves subject to fda approval – many district courts have remained silent on the issue. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 155 hand, is a federal circuit decision in which a research tool was excluded from the safe harbor.91 though the supreme court has used broad terms to define the safe harbor’s “patented invention” and expressly avoided answering the question of whether a research tool is shielded under § 271(e)(1), at least two district courts have read proveris to categorically exclude research tools as a “patented invention” under § 271(e)(1).92 in contrast, the sandoz decision from the southern district of new york above dismissed multiple patent infringement claims arising from the use of patented polypeptide markers to measure the molecular characteristics of a generic drug seeking fda approval.93 characteristic of most research tools, the polypeptides were themselves not subject to fda approval.94 interpreting abtox, the district court in sandoz firmly asserted that “[i]n construing that all classes of medical devices fell within the scope of the safe harbor (not just those subject to fda approval), the federal circuit relied upon the language of the statute and the supreme court's broad language in eli lilly.”95 with the supreme court holding a broad view of which inventions fall under the safe harbor, the federal circuit now construing that precedent narrowly, and district courts landing on both sides and in-between, some enterprising innovators have been willing to risk litigation rather than seek licensing on crucially important technologies. iii. use now, litigate later a. two controversies two patent infringement lawsuits, one still pending, highlight the uncertainty around research tools under the safe harbor. allele biotechnology & pharmaceuticals inc. filed suit against two defendants in two different federal district courts on the same day.96 allele filed against regeneron in the united states district court for the southern district of new york on october 5, 2020,97 and against pfizer in the united states district court for the southern district of california.98 the lawsuits both allege infringement of the same patented 91. proveris sci. corp., 536 f.3d at *1261. 92. allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 85347, at *12 (s.d. cal. may 4, 2021). 93. teva pharma. usa, inc. v. sandoz inc., 2013 wl 3732867, *2 (s.d.n.y. 2013). 94. id. 95. id. at *7. 96. regeneron has its principal place of business, maintains its registered office, and is incorporated in the state of new york. complaint, allele biotechnology & pharm., inc. v. regeneron pharm., inc., no. 20-cv-08255, 2021 wl 2880694, at *1 (s.d.n.y. apr. 8, 2021). thus, venue was proper and easy to attain in the southern district of new york. 97. complaint, allele biotechnology & pharm., inc. v. regeneron pharm., inc., no. 20-cv08255, 2021 wl 2880694, at *1 (s.d.n.y. apr. 8, 2021). 98. allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 85347, at *1 (s.d. cal. may 4, 2021). 156 indiana health law review [vol. 20:143 technology expressly identified as a research tool. further, the alleged activity of the defendants did not materially differ. both defendants, among other alleged activity, used mneongreen in neutralization assays which inserted a gene chimera from allele’s fluorescent protein into the sars-cov2-19 viral genome for purposes of tracking its proliferation and related behavior.99 the choice to file in two different jurisdictions, though perhaps essential to easily ensure proper venue, may prove to highlight a particular uncertainty in the law on an integral issue. four subjects will be considered briefly. first, the prospect of the remaining case going to trial, and its suitability for appeal and clarification of an unresolved issue of the safe harbor’s interpretation will be addressed in this section. second, this section will consider whether the relevant analysis offered by the court so far is legally satisfying. third, this section will provide a brief consideration of the possible outcomes. lastly, a bright-line rule will be proposed which aims to resolve statutory ambiguity. 1. patent at issue prior to the spread and discovery of sars-cov2-19, allele had developed and patented mneongreen – a monomeric fluorescent protein – as united states patent no. 10,221,221.100 such a protein is useful as a biomarker to track or identify certain molecules and, among other applications, gives researchers a window into the effectiveness of therapeutics designed to generate antibodies.101 in an effort to enhance the standing of its cases against regeneron and pfizer, allele argued mneongreen is the best fluorescent protein available and has been referred to objectively by third-parties as the “[k]ing of fluorescent proteins.”102 2. accused activity before pfizer, or any other therapeutic developer was directly involved, a university used mneongreen to develop the “gold standard” covid-19 assay for evaluating vaccine effectiveness and differentiating between which therapeutic was most and least effective.103 allele alleges pfizer and biontech then used this assay, along with the patented florescent protein, for commercial testing, development, and ultimately selection of their mrna prophylactic covid-19 vaccine during clinical trials.104 by testing antibody levels of patients during clinical trials, pfizer selected a winning vaccine from among several bnt162 99. amendedcomplaint at 4, allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv01958-h, 2021 u.s. dist. lexis 85347 (s.d. cal. feb. 25, 2021). 100. id. at 2. 101. id. at 4. 102. id. at 6. 103. id. at 2. 104. id. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 157 mrna candidates.105 similarly, allele alleges regeneron pharmaceuticals used mneongreen to detect a pseudoparticle reporter indicating the presence of sarscov-2 neutralizing antibodies.106 in sum, allele alleged both pfizer and regeneron emerged as front runners in the race to a vaccine precisely because of their unlicensed use of mneongreen.107 noting mneongreen is not itself subject to premarket approval under any federal law, allele argued against applying the safe harbor.108 3. legal issue: complaint and defense allele, in both complaints alleging infringement of the 221 patent, specifically identify mneongreen as a research tool.109 in addition to denying nearly all of allele’s allegations, asserting allele’s patent is invalid, and asserting non-infringement of the patent, pfizer raised § 271(e)(1) as an affirmative defense against patent infringement.110 accordingly, pfizer filed a motion to dismiss the lawsuit, arguing its use of mneongreen was sheltered by the statutory safe harbor.111 similarly, regeneron filed a motion to dismiss under federal rules of civil procedure 12(b)(6), arguing allele had failed to state a claim upon which relief could be granted.112 as expected, regeneron filed its support to this motion on august 20, 2021.113 unsurprisingly, it ardently pointed out that sandoz expressly included research tools in the safe harbor: emphasizing sandoz’s found that “‘[t]he statutory safe harbor is clear’ and ‘patented invention’ is defined by 35 u.s.c. § 100(a) to broadly mean ‘invention or discovery.’”114 further, regeneron argues that whatever proveris stated concerning the term “patented invention,” 105. id. at 10-11. 106. amended complaint at 9, allele biotechnology & pharm., inc. v. regeneron pharm., inc., no. 20-cv-08255, 2021 wl 2880694 (s.d.n.y apr. 8, 2021). 107. amendedcomplaint at 11, allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv01958-h, 2021 u.s. dist. lexis 85347 (s.d. cal. feb. 25, 2021); see also second amendedcomplaint at 10, allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 85347 (s.d. cal. feb. 25, 2021). 108. id. at 7. 109. id. at 11; see also amendedcomplaint at 12, allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 85347 (s.d. cal. feb. 25, 2021). 110. answer at 34, allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 85347 (s.d. cal. june 3, 2021). 111. motion to dismiss at 1, allele biotechnology and pharmaceuticals, inc. v. pfizer inc., 20-cv-01958-h-ags, 2021 wl 2774550 (s.d. cal. april 23, 2021). 112. notice of motion at 1, allele biotechnology & pharm., inc. v. regeneron pharmaceuticals, inc., no. 20-cv-08255, 2021 wl 2880694 (s.d.n.y aug. 20, 2021). 113. reply memorandum of law at 2, allele biotechnology & pharm., inc. v. regeneron pharmaceuticals, inc., no. 20-cv-08255, 2021 wl 2880694 (s.d.n.y aug. 20, 2021). 114. id. at 2 (quoting teva pharm’s usa, inc. v. sandoz, inc., 2013 wl 3732867, at *7 (s.d.n.y. 2013)). 158 indiana health law review [vol. 20:143 and a dependence on it being subject to fda approval, was mere dicta because proveris itself did not turn on that holding.115 rather, regeneron argues, proveris rejected application of the safe harbor “because the defendant’s use was not related to generating data for fda submission.”116 asserting proveris offered only dicta on the scope of “patented invention” appears to be bold, and in the minority view. however, the case has been filed in a jurisdiction which has shown favor to that vary approach and the litigation remains pending. b. status of pfizer litigation 1. motion to dismiss denied the action against pfizer was filed with the united states district court for the southern district of california. prior to resolution by settlement on january 5th, 2022, three orders on motions were issued from judge marilyn l. huff.117 two related to motions to dismiss and compel, respectively, and are of little import to the safe harbor issue.118 of particular interest, in may 2021, the court denied pfizer's motion to dismiss under federal rules of civil procedure 12(b)(6) on the theory that, as a matter of law, allele had failed to state a claim upon which relief could be granted.119 according to pfizer, even if the patent was valid and pfizer’s activity constituted elements of infringement, as allele alleges, the activity was shielded under the safe harbor of § 271(e)(1) and, as such, allele was never entitled to any of the relief it requested.120 in denying this motion, the court noted that two federal district courts have held research tools, which are not subject to fda approval, are not shielded under the safe harbor.121 though the legal standard for a successful 12(b)(6) favors the plaintiff,122 the u.s. district court for the 115. id. 116. id. at 1-2. 117. see allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 37287 (s.d. cal. feb. 26, 2021). see also allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 174654 (s.d. cal. sep. 13, 2021). 118. id. 119. allele biotechnology & pharm., inc. v. pfizer, inc., 20-cv-01958-h-ags, 2021 u.s. dist. lexis 85347, at *3 (s.d. cal. may 4, 2021). 120. id. at *5. 121. id. at *11. see also isis pharms., inc. v. santaris pharma a/s corp., no. 11cv02214, 2012 u.s. dist. lexis 134107, 2012 wl 4111157, at *4 (s.d. cal. sept. 19, 2012) ("the safe harbor does not apply, however, when a biological compound is used to perform 'basic scientific research' or as a 'research tool.'"), and psn ill., llc v. abbott labs. & abbott bioresearch ctr., inc., no. 09 c 5879, 2011 u.s. dist. lexis 108055, 2011 wl 4442825, at *5 (n.d. ill. sept. 20, 2011) ("proveris excluded research tools from the purview of the safe harbor exemption."). 122. allele biotechnology & pharm., inc. v. pfizer, inc., 20-cv-01958-h-ags, 2021 u.s. dist. lexis 85347, at *4 (requiring all questions of fact to be resolved in favor of the non-moving party). 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 159 southern district of california suggested, in its refusal to dismiss the action against pfizer, that it reads eli lilly and proveris to teach research tools are outside the scope of the “patented invention” of § 271(e)(1).123 interestingly, discussion of the supreme court case of merck–a case which contains what some have viewed as expansive language suggesting research tools rest within the ambit of § 271(e)(1)–is limited to one paragraph and avoided entirely in the court’s analysis section.124 aside from several quotes unanchored by meaningful context, the court reports merck’s broadest statement only in parentheses and removes the supreme court’s emphasis. indeed, the court’s lack of focus on merck suggested it would not extend merck’s sweeping principles to research tools.125 notably, merck was seemingly replaced with a discussion easily distinguishing classen v. elan pharms in the court’s brief analysis and subsequent rejection of pfizer’s motion to dismiss.126 perhaps merck’s direct refusal to address research tools has been taken by some courts to relieve its application of the general statements therein.127 the appropriateness of this maneuver will be considered later. though not excepted by all courts, the u.s. district court for the southern district of california made it clear, as a matter of law, the safe harbor would not shield pfizer’s activity.128 since juries generally favor patent holders, the parties could assess their chances of success and the outcome of the jury trial which was set for late 2022. this proved enough information to settle. it is safe to say the terms of the settlement were in allele’s favor–favor obviously dependent on the court’s refusal to apply the safe harbor. 2. status of regeneron litigation a similar motion to dismiss was filed by regeneron on august 8, 2021, with the southern district of new york, which was dismissed on march 2, 2022.129 a status update from allele on december 13, 2021, indicated regeneron had ceased all use of mneongreen in its current research and development of next generation antibody cocktails and notified allele.130 allele has accordingly withdrawn 123. see santaris pharma a/s corp., u.s. dist. lexis 134107, at *4 ("the safe harbor does not apply, however, when a biological compound is used to perform 'basic scientific research' or as a 'research tool.'"), and abbott labs. & abbott bioresearch ctr., inc., u.s. dist. lexis 108055, at *5 ("proveris excluded research tools from the purview of the safe harbor exemption."). 124. id. 125. id. at *8. 126. elan pharm., inc., 786 f.3d at 896-97 (the court states the defendant’s reliance on elan pharm. is misplaced because the issue relates strongly to the nature of the activity instead of the invention being used). 127. allele biotechnology & pharm., inc., 2021 u.s. dist. lexis 85347, at *15. 128. elan pharm., inc., 786 f.3d at 896-99. 129. status update at 1, allele biotechnology & pharm., inc. v. regeneron pharmaceuticals, inc., no. 20-cv-08255, 2021 wl 2880694 (s.d.n.y apr. 8, 2021). 130. id. 160 indiana health law review [vol. 20:143 associated allegations of continued use of their patented technology, but has retained other allegations.131 while regeneron’s move is difficult to legally construe, it could be an indication both parties are also likely to negotiate a settlement. 3. settlement of trial: jury or bench with about 96 percent of patent infringement lawsuits settled before trial,132 it is statistically unlikely that an individual case would receive a written opinion from a judge on appeal, though a case is slightly more likely to be resolved on a granting of summary judgment.133 with some lawsuits being dismissed or abandoned, only about 1.5 percent of filed patent infringement lawsuits are litigated to a conclusion.134 of these, however, an increasing number are being submitted to a jury for deliberations.135 though jury trials significantly increase both the chances a patent holder wins and their corresponding average award,136 they are the costliest form of resolution.137 for a jury trial to advance, both parties must sharply disagree on what damages, if any, will restore the interests of the plaintiff. for cases of ordinary circumstances–where damages from comparable lawsuits are readily available–settlement is likely in the best interest of both plaintiff and defendant. time and resources consumed by trial are often not worth the statistically larger award. allele, however, filed a case against pfizer which was not average in several respects. it was arguably worth an extraordinary reward. when viewed as a single industry, biotech and pharmaceuticals garner infringement damages which dwarf those of other industries.138 further, pfizer has made a veritable fortune from the vaccine.139 if allele had been left to convince a jury pfizer was first to an effective therapeutic because of a deliberate and unauthorized use of mneongreen, allele would have also happily asked that jury to consider exactly 131. id. 132. branka vuleta, 25 patent litigation statistics-high-profile feuds about intellectual property, legaljobs (aug. 6, 2021), https://legaljobs.io/blog/patent-litigation-statistics/#:~:text= a%3a,year%20in%20the%20united%20states [https://perma.cc/w59f-xz7h]. 133. id. 134. id. 135. id. 136. landan ansell et al., 2018 patent litigation study, price waterhouse coopers 1, 6-7 (may 2018), https://www.ipwatchdog.com/wp-content/uploads/2018/09/2018-pwc-patent-litigationstudy.pdf [https://perma.cc/8hn5-33cq]. 137. vuleta, supra note 132. 138. ansell et al., supra note 136 (in a 20-year study where the median damage award over all industries was $5.9 million, the biotech/pharma industry had a median award per case exceeding $20 million). 139. zachary brennan, moderna's covid-19 vaccine sales to trail pfizer's total significantly in 2021 and 2022, endpoints news (aug. 5, 2021), https://endpts.com/modernas-covid-19vaccine-sales-to-trail-pfizers-total-significantly-in-2021-and-2022/ [https://perma.cc/a8j4-33eb]. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 161 what part of pfizer’s projected $33 billion in 2021 revenue belongs to allele.140 though pfizer has settled, an analogous consideration applies against regeneron with respect to the wide use of its antibody cocktail–including the high-profile treatment of then-president donald trump, after he contracted the illness prior to vaccine availability. pleadings in both cases force an answer on the research tool question–an unresolved conflict which has garnered much attention. though allele has resolved pfizer’s case without option to refile, it is conceivable that amicus briefs and similarly interested parties would aptly vie for resolution on this issue. this factor suggests regeneron’s case may be ripe for escalation to higher courts. high-profile players produced a product which has become a household name on a global scale–largely due to the significance of the covid-19 outbreak.141 the accompanying money, motive, and resources may help extrude a final answer to the research tool question. iv. analysis a. on the denial of motions for summary judgement 1. right outcome it is helpful to understand the significance of the denial to grant pfizer’s motion to dismiss. pfizer asserted a motion to dismiss because of allele’s alleged “failure to state a claim upon which relief can be granted.”142 for this motion to succeed against the plaintiff, the pleadings must not contain “enough facts to state a claim to relief that is plausible on its face.”143 in determining this, the court may ignore naked assertions and legal conclusions, amounting to formulaic recitations of the elements of the cause of action–but only when they are lacking further factual enhancement.144 the burden of establishing a facially plausible claim rests with the plaintiff and factual disagreement is to be resolved in favor of the nonmoving party.145 after a conforming rule 8 pleading is submitted by the plaintiff, the burden then shifts to the defendant to show, even if the alleged facts are true, the plaintiff would not be positioned to collect any remedy.146 here, pfizer’s argument rested principally on the safe harbor for protection to bar allele from any recovery. with the scope of the safe harbor being one of contention and the 140. id. 141. id. 142. fed. r. civ. p. 12(b)(6). 143. bell atl. corp. v. twombly, 550 u.s. 544, 570 (2007). 144. id. at 557, 564. 145. daniel c. cooley & justin e. loffredo, a refresher on the standards of pleading direct patent infringement, ip litigator (dec. 2020), https://www.finnegan.com/en/insights/articles/arefresher-on-the-standards-of-pleading-direct-patent-infringement.html [https://perma.cc/497yhdwr]. 146. id. 162 indiana health law review [vol. 20:143 precedent of the southern district of california, denial of a motion to dismiss was not surprising. even so, the scope of the safe harbor will likely be questioned again in the southern district of california. similarly, and relying on similar rationale, the march 2nd denial of regeneron’s motion to dismiss will likely not be the last time the scope of the safe harbor is at issue in the southern district of new york.147 indeed, it may be raised again in later proceedings involving this same litigation. whether the § 271(e)(1) safe harbor applies is a mixed question of law and fact. as to law, it depends on the definition of the “patented invention” of § 271(e)(1). as to fact, it depends on what mneongreen is and where it falls in relation to the judicially endorsed definition. whether these questions coincide in the law-fact continuum remains a mystery, and so, it is no surprise the court ultimately dismissed both defendant’s motions for summary judgement. based on variation between courts, it is difficult to say whether mneongreen, though it be a research tool, falls under the purview of the safe harbor. it is important to note that the court only stated pfizer had “failed to demonstrate that the facts alleged in the [complaint] establish that the allegedly infringing activity is exempted” under the safe harbor.148 the court may be alluding to an answer turning on activity instead of subject matter contemplated by the “patented invention” of the safe harbor. 2. limited rationale the court, in its denial to dismiss the case against pfizer, points out that the defendant’s reliance on sandoz is unpersuasive and ineffectual because it is a non-binding district court opinion.149 however, this same rationale disembowels its own reliance on two district courts who have interpreted proveris to categorically exclude items not subject to fda approval from the “patented invention” of § 271(e)(1).150 the court resorts to ‘cherry picking’ of lateral, nonbinding interpretations of proveris exactly because its binding precedent–the federal circuit and supreme court–have not yet enunciated the bright-line rule it seeks. federal district courts have been criticizing each other’s interpretation of their mutually binding precedent. this silence to-date by the federal circuit and supreme court raises questions of unacceptable ambiguity for those who innovate in the field of research tools. the court, in allele’s case against pfizer, quotes from proveris to purportedly show a rule requiring an invention be subject to fda approval to receive safe 147. see cooley & loffredo, supra note 145. 148. allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv-01958-h, 2021 u.s. dist. lexis 85347, at *18 (s.d. cal. may 4, 2021). 149. id. at *17. 150. id. at *12; see also eli lilly & co. v. medtronic, inc., 496 u.s. 661, 665, 672 (1990) (to state “all inventions, not drug related inventions” are within the ambit of § 271(e)(1) formally marks at least one aspect of asymmetry between § 156 and § 271). 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 163 harbor protection.151 after noting proveris’ patented device is not eligible for § 156 patent term extension because it is not subject to fda approval, the proveris court added that “because innova's osa device also is not subject to a required fdca approval process, it does not need the safe harbor protection afforded by 35 u.s.c. § 271(e)(1).”152 the court relies heavily on this quotation. while it is true proveris goes on to treat subjection to fda approval as a requirement to be under the safe harbor, the last word on that subject from the supreme court was only that such symmetry be “preferable.”153 was proveris wrong to add a limitation the supreme court did not? was this language mere dicta, as sandoz surmised? such a reading of proveris may conflict with the holding in merck, where the patented peptides only had hopes of producing material for fda submissions but were nonetheless protected.154 is the rule potential subjection to fda regulation? further, abtox, the federal circuit decision, where a non-fda regulated plasma sterilizer was shielded by the safe harbor, has not been overruled.155 in sum, whether a district court should require a product be subject to fda approval for application of the safe harbor is a matter reasonable interpretations of current case law can (and do) differ on. further, three times throughout the denial of the motion to dismiss, the california district court emphasizes the ‘perfect “product” fit’ described in eli lilly.156 while the symmetry between § 156 and § 271 is dependent on an invention itself being subject to fda approval, eli lilly used this fact to explain why § 271(e)(1) extended to a patented medical device, refusing to limit its scope to drugs, to maintain this symmetry. this maneuver by some was regarded as expanding a term once presumptively limited to drugs. though the connection is perfectly logical, eli lilly is not the latest binding precedent a district court must reconcile before arriving at a conclusion. merck was decided in 2005 and builds on eli lilly to extend–not limit–the scope of § 271(e)(1) inventions. referring to eli lilly, merck states it is “apparent from the statutory text that § 271(e)(1)'s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the fdca.”157 whether “any information” signifies that the information need not relate to approval of the subject patented invention has not been answered by the supreme court, and as we have already seen, is a subject of disagreement in lower courts.158 it has been over fifteen years since this textualistic statement of the statute concerned holders of research tool patents. admittedly, the context is principally 151. id. at *9. 152. proveris sci. corp. v. innovasystems, inc., 536 f.3d 1256, 1266 (fed. cir. 2008). 153. eli lilly & co., 496 u.s. at 666. 154. merck kgaa v. integra lifesciences i, ltd., 545 u.s. 193, 208 (2005). 155. abtox, 122 f.3d at 1029. 156. allele biotechnology & pharm., inc., 2021 u.s. dist. lexis 85347, at *11, *13, *17. 157. merck kgaa, 545 u.s. at 202. 158. see teva pharms. usa, inc. v. sandoz, inc., no. 09 civ. 10112, 2013 wl 3732867, at *6-7 (s.d.n.y. july 16, 2013). 164 indiana health law review [vol. 20:143 aimed at defining the “reasonably related” phrase in the statute.159 however, in the same way merck (primarily concerned with the scope of reasonably related) harmonizes with eli lilly (primarily concerned with the scope of patented invention), a more fulsome explanation must bound the broad principles in merck as limited to the context of reasonably related activity and not conflicting with a yet to be articulated general rule concerning research tools. again, the scope of “reasonably related” has not been defined in isolation: courts can and have woven themes of reasonably related into analysis evaluating research tools as patented inventions.160 with the significance of the patented invention’s subjection to fda approval formally left open for the lower courts, allele presents a high-profile opportunity where an unlicensed use of a patented research tool may be analyzed to provide clarity on that point.161 3. final outcome inconsistency between courts on this matter is not a distant obscurity. a student of the subject need only assess the probable outcome of these two cases based on each jurisdiction’s precedent. as illuded to above, prior to settlement, allele’s complaint in the southern district of california survived a motion to dismiss and the jurisdiction has recent precedent categorically excluding patented inventions not subject to fda approval from the safe harbor. collectively, this suggests the southern district of california is unlikely to extend the safe harbor to immunize the future use of patented research tools. indeed, this is not the first time, or the last time, the southern district of california has articulated a narrow reading of proveris.162 in contrast, the southern district of new york, in which allele has filed suit against regeneron, has a recent case where the use of so-called research tools was shielded under the safe harbor. therefore, it once appeared two cases alleging similar use of the same patented invention were queued up for different outcomes. however, on march 2, 2022, regeneron’s motion to dismiss, a motion analogous 159. justice scalia is known for strict textualistic reading of statutes and was often skeptical of using legislative history to interpret statutes. he argued it could often support both sides and may have been produced to yield an interpretation not voted on by congress. see merck kgaa, 545 u.s. at 202, 206, 208 (in each passage scalia refuses to impose a limitation on “patented invention” which was not introduced by the statute’s text). 160. see teva pharms. usa, inc., 2013 wl 3732867, at *6 (quoting from merck specifically when assessing whether the patented invention used must itself be subject to fda approval). see also allele biotechnology & pharm., inc., 2021 u.s. dist. lexis 85347, at *7 (reconciling merck with its narrower application of the safe harbor in the context of “patented invention”). 161. merck kgaa, 545 u.s. at 208 n.7 (footnote 7 in merck states that though the court of appeals argued limiting § 271(e)(1) was appropriate to protect patents on research tools, the supreme court explicitly declined to “express a view about whether, or to what extent,” research tools should fall under the safe harbor). 162. see isis pharms., inc. v. santaris pharma a/s corp., no. 11-cv-02214, 2012 u.s. dist. lexis 134107, at *11 (s.d. cal. sept. 18, 2012). 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 165 to pfizer’s motion, was similarly denied. as of july 31, 2022, both parties are preparing for a jury trial, the outcome of which will likely raise the research tool question again on appeal. whether on appeal in this case, or in future cases with arguably distinguishable facts, the contradictory case law will be advanced, and the judge will resolve each case. this scenario is contrary to the desire for consistency in the law and raises questions related to forum shopping, equity, and predictability of the patent laws. b. the future of the controversy 1. an important opportunity several factors unique to allele’s case against regeneron make it a candidate to solidify the status of research tools under § 271(e)(1). first, there is no dispute as to the nature of mneongreen—it is squarely a research tool and used as such in the allegedly infringing activity. relatedly, it is not itself subject to fda approval. second, though the proveris holding will almost certainly be considered relevant, the aerosol spray analyzer in that case was not in fact used for research by the defendant.163 rather, it was used for measuring data from a fully designed consumer product—the data required by the fda before sale.164 further, the aerosol spray analyzer in proveris was being sold by the defendant to third parties who would use it for obtaining data for fda submissions. in other words, innova was making the device to sell it for a direct profit, not conduct research themselves—potentially more scandalous than in-house use of a molecular compound. notably, mneongreen is used for research of promising compounds, in identifying one which may be advanced and eventually require submission to the fda. in that sense, there are factual similarities with merck.165 though it is not the actual compound with hopes of fda submissions being directed at it, as in merck, mneongreen appears to have been genetically integral to those very compounds for the purposes of research.166 in short, proveris may be distinguishable, as mneongreen is the quintessential research tool. thirdly, the financial stakes could scarcely be higher. though the parties are not financial equals, both have adequate access to funding to fully litigate the matter.167 alleles technology was powerful. to illustrate, mneongreen assisted 163. proveris sci. corp., 536 f.3d at *1264. 164. id. 165. merck kgaa, 545 u.s. at 193 (merck states “§ 271(e)(1) exempts from infringement the use of patented compounds in preclinical research, even when the patented compounds do not themselves become the subject of an fda submission.”). 166. amended complaint at 4, allele biotechnology & pharm., inc. v. pfizer, inc., no. 20-cv01958-h, 2021 u.s. dist. lexis 85347 (s.d. cal. feb. 25, 2021). 167. allele biotechnology and pharmaceuticals inc., https://www.allelebiotech.com [https://perma.cc/74uk-m7uv] (last visited oct. 24, 2021); see also pfizer gross profit 2006-2021 | pfe, marcotrends, https://www.macrotrends.net/stocks/charts/pfe/pfizer/gross-profit [https:// perma.cc/jja7-rl8t] (last visited nov. 14, 2021) (allele is a private corporation with $18m in 166 indiana health law review [vol. 20:143 pfizer in being first to market in the vaccine race—allowing it to immediately secure $400 million in grants,168 an immediate multi-billion-dollar sales contract with the u.s. department of health and human services and the department of defense,169 and maintain leading revenues in continued vaccine sales.170 likewise, regeneron used allele’s mneongreen to be beat competitors to an effective antibody therapeutic for those infected with sars-cov-2, helping it capture over $2.59 billion in antibody-related revenue alone in just the second quarter of 2021.171 assigning a monetary value to that advantage may prove difficult. if successful securing a verdict for infringement, allele hopes to task a jury with just such a difficult determination. what share of regeneron’s profits belong to allele? as such, regeneron is strongly motivated to secure a noninfringement verdict. with the non-infringement so far denied, settlement negotiations will surely be considered. however, if negotiations are unsuccessful, the safe harbor issue is sure to arise again on appeal. 2. benefit of a bright-line rule in a word, the benefit of having a bright line rule in law is commonly noted as predictability.172 in the same way detailed statutes and case law on corporations offer value to business ventures seeking to organize as a corporation, a clear interpretation of § 271(e)(1)’s “patented invention” would offer research tool users and developers value. this clarity would add predictability to respective liabilities and inform disputes prior to the cost of judicial involvement. information concerning liability, or the lack thereof, for use of research tools will influence how researchers allocate resources for research and development. the total funding from three investors while pfizer regularly reports annual profits in excess of $30 billion). 168. rebecca tapscott, regeneron, pfizer and biontech accused of infringing allele patent in connection with covid-19 technologies, ipwatchdog (oct. 7, 2020), https://www. ipwatchdog.com/2020/10/07/regeneron-pfizer-biontech-accused-infringing-allele-patentconnection-covid-19-technologies/id=126017/ [https://perma.cc/a9vd-58hg]. 169. pfizer and biontech announce an agreement with u.s. government for up to 600 million doses of mrna-based vaccine candidate against sars-cov-2, businesswire (july 22, 2020), https://www.businesswire.com/news/home/20200722005438/en/ [https://perma.cc/m4af2z2d]. 170. kevin dunleavy, pfizer, moderna will rake in a combined $93 billion next year on covid-19 vaccine sales: report, fierce pharma (oct. 18, 2021), https://www.fiercepharma. com/pharma/pfizer-moderna-will-rake-a-combined-93-billion-next-year-covid-19-sales-saysanalytics-group [https://perma.cc/jj6v-dx9s]. 171. kevin dunleavy, surprise covid-19 antibody sales of $804m help regeneron trounce expectations in third quarter, fierce pharma (nov. 4, 2021), https://www.fiercepharma. com/pharma/surprise-antibody-sales-804-million-help-regeneron-exceed-revenue-expectationsthird-quarter [https://perma.cc/3ujw-872x]. 172. bright-line rule, cornell l. sch., https://www.law.cornell.edu/wex/bright-line_rule [https://perma.cc/w5xa-wll4] (last visited oct. 23, 2021). 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 167 clearer the rule, the more efficient the outcome. the interpretation of § 271(e)(1) needs a bright-line rule. 3. danger of a bright-line rule why has the court been so reluctant to provide a bright-line rule on the status of research tools under the safe harbor provision of § 271(e)(1)? first, bright-line rules are often deemed mechanical, objective, and invariant. when applied across all cases, mitigating factors or extenuating circumstances may be silenced, underemphasized or ignored entirely–thus violating a sense of fairness in a given outcome.173 second, courts do not like to tie their own hands. a clear rule will demand an outcome given some triggering fact pattern–regardless of an unforeseen nuance the court would have rather weighted more heavily. third, and most relevant in the present instance, issuing a bright-line rule limiting statutory language which appears broad to a judge requires reading more than the words of the legislature–it often requires supposing intent of the legislature–anathema to a strict textualist.174 4. a conflict between courts another obstacle to the adoption of a bright line rule is the furthering of a controversial influence of the supreme court on the country’s patent laws. of course, the supreme court has general subject matter jurisdiction and is superior to the federal circuit. however, the federal circuit was specifically created to resolve patent disputes and provide better predictability in patent law.175 to what extent the supreme court should assert itself in reviewing the court specifically designated to resolve patent disputes has been, and will continue to be, debated. the supreme court has a habit of reversing the federal circuit on patent cases, and has become increasingly active in doing so over the last twenty years–reversing twenty two out of twenty seven cases between 2005 and 2015.176 with the vast majority of reversals favoring an alleged infringer, it is not surprising the supreme court is considered hostile to patent holders; the federal circuit is notably more likely to uphold the validity of a patent.177 though the supreme court is the highest authority in united states patent law, it has a 173. id. 174. see merck kgaa, 545 u.s. at 202, 206 (justice scalia’s aversion to “read narrowly” where the statutory text “provides a wide berth” is both illustrative in general and captures the issue in the context of this exact statute). 175. cong. research serv., patent law and innovation: the creation, operation and a twenty-year assessment of the u.s. court of appeals for the federal circuit 1 (2003). 176. osha bergman watanabe burton, why does the u.s. supreme court keep reversing the federal circuit? (mar. 31, 2017), https://www.obwbip.com/newsletter/why-doesthe-u-s-supreme-court-keep-reversing-the-federal-circuit [https://perma.cc/9xb3-qje2]. 177. id. 168 indiana health law review [vol. 20:143 limited docket for reviewing patent cases and the federal circuit generally has the final word on all but a handful178 of the roughly 450 cases decided annually.179 as such, though speculation often erupts with any supreme court decision perceived as threatening the enforceability of patents, as in merck,180 concern is generally quelled shortly thereafter by the less rigid and more patent-holderfriendly, application by the federal circuit. with a practical limit on case-by-case enforcement, the threat of undesirable rigidity, and a tendency for the federal circuit to ameliorate resultant rules, might a bright line rule from the supreme court quickly become blurry? to answer this question with any persuasiveness will require unfolding the proposed rule–which will now be explained quite simply. 5. the proposed resolution the supreme court, potentially in response to these cases, should enunciate a rule ensuring the enforceability of patents directed at research tools. the defining characteristic of this class of inventions is that they are not themselves subject to fda approval. hence, the safe harbor of § 271(e)(1) should not apply to research tools and strict symmetry between § 156 and § 271(e)(1) should be an unambiguous requisite for shielding under the safe harbor. it is this author’s position that a bright line rule from the supreme court on this issue would not be subject to typical vulnerabilities or ineffectual application in the lower courts. initially, with respect to the rigidity of the rule, the concern surrounding a harmful mechanical application is quelled due to the nature of the players in this industry. those made subject to liability after any narrowing of the safe harbor are largely sophisticated players with a close eye on this very topic. a word of warning would spread rapidly through a tight community of highly skilled research professionals. this warning would allow them to quickly license their use of equipment belonging to a now emboldened patent holder or seek an alternative technology. those affected know they are affected and generally have suitable resources to respond. beyond the parties affected, a second factor strongly supporting the success of a bright line rule in this case relates to the nature of the rule itself. formally recognizing the criteria of fda approval calls for an objective test which is resolved through a purely factual inquiry. there is no heavy lifting required by courts to expand upon the ‘reasonableness’ standard. 178. devin salmon, a sign of the times? a brief look at the trend of patent cases before the us supreme court, ip.com, https://ip.com/blog/a-sign-of-the-times-a-brief-look-at-the-trendof-patent-cases-before-the-us-supreme-court/ [https://perma.cc/g8nt-lhjh] (last visited oct. 22, 2021) (though the supreme court has averaged just one or two patent cases per year over the last 80 years, it has roughly tripled this average over the last 10 years). 179. dan bagatell, fed. cir. patent decisions in 2019: an empirical review, law360 (jan. 9, 2020), https://www.law360.com/articles/1232623/fed-circ-patent-decisions-in-2019-anempirical-review [https://perma.cc/e8ty-f9ja]. 180. see supra note 26 and accompanying text. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 169 a third factor forecasting the success of the rule relates to the dynamic between the supreme court and the federal circuit. simply put, the rule would generally support patent enforceability and be favored in its most simple form at the federal circuit. further, if a desire to alter the rule arose, there is little nuance to leverage. with two recent controversies emerging in jurisdictions having uncertain precedent, historical revenues at stake, and plenty of interested money available for advocacy, the supreme court should consider resolving these cases with a landmark decision of clarity. as far as the safe harbor is concerned, there is disagreement and ambiguity on specialized doctrine. whether research tools fall under the safe harbor is a matter lower courts can manipulate by selective use of precedent. this yields uncertainty, expense, and potentially fosters bad faith in competition. alternatively–and indeed the most direct means of clarification–would be for the legislature to take unilateral action. a sufficient action from the legislature would consist of merely an exchange of the term “patented invention” in § 271 for the § 156 “product” and it’s associated definition.181 with decades of this debate as context, and § 156’s explicit definition of “product”–being limited to articles subject to fda approval182 –this would result in a clear understanding and virtually immediate predictability among courts. c. the scope of relevance 1. illustrative importance of research tools i) molecular biomarkers much of the litigation discussed centers on this class of research tools, but why are they important? as has been explained, mneongreen and other fluorescent proteins are considered “marker” or “indicator” proteins. in the case of vaccine research, they annunciate the existence of antibodies successfully produced during clinical trials of vaccines or similar activities. more generally, molecular biomarkers are used to “diagnose disease, monitor disease progression and response to therapy, and are targets for development of new drugs.”183 generally, these biomarkers are not subject to fda approval since they are not administered to patients. a lack of patent protection for molecular biomarkers would allow uncompensated use and copying in a majority of their applications–reducing both the value of the inventions and investment in the technology. 181. § 156(f). 182. id. 183. keck graduate inst., about the center for biomarker research, https://www.kgi.edu/ faculty-and-research/centers-initiatives/center-for-biomarker-research/ [https://perma.cc/tlf37y5q] (last visited oct. 24, 2021). 170 indiana health law review [vol. 20:143 ii) medical laboratory devices medical devices used as research tools are more intuitive and are indeed ubiquitous. from laboratory microscopes to centrifuges, this class of tools is interacted with in a high-school science classroom and the occasional visit to the general practitioner. some of these devices are subject to fda approval, such as a cardiac defibrillator, and in that sense, do not fall within the typical definition of a research tool. generally, devices used in laboratory settings are not subject to fda approval and would be at risk of losing patent protection if research tools were widely included in the ambit of § 271(e)(1). a loss of commercial value in the development of new and improved laboratory equipment, by the unencumbered copying by competing manufacturers, would diminish the investment in this industry and reduce published technological advances. iii) artificial intelligence one technology often classified as a research tool is artificial intelligence (ai). for ai to be patentable it must do more than perform mathematical formulas, mental processes, or organize ordinarily human activity.184 even so, thousands of ai related patents have met that burden and have been granted. the growth of ai patents in the medical industry has experienced rapid acceleration since 2011 due to a significant increase in big data analytics and improvements in computing power.185 patents on ai research tools–especially those mining and predicting usefulness of the astronomical number of uncharted chemical compounds–will become increasingly contentious as the space gets crowded.186 for prospective investors, it will be increasingly important to understand the issue of ai as research tools under patent protection prior to entering into this new era. ai is particularly vulnerable to copying as it is often, in large part, code which is run on a supercomputer. 2. importance of patent protection whether the right to exclude extends to lawfully patented research tools must be clearly answered in the affirmative to secure current investment, and promote future investment, in the above industries of public import. if a patented research tool, requiring a large capital investment, can be used without compensation 184. andrew rapacke, are machine learning algorithms patentable?, rapcke l. grp. (jan. 27, 2020), https://arapackelaw.com/patents/softwaremobile-apps/are-machine-learning-algorithmspatentable/ [https://perma.cc/jax2-vy5v]. 185. yang xin et al., the development trend of artificial intelligence in medical: a patentometric analysis, (1) a.i life sci. 100006 (2021). 186. sam lemonick, exploring chemical space: can ai take us where no human has gone before?, chem. & eng’g news (apr. 6, 2020), https://cen.acs.org/physical-chemistry/ computational-chemistry/exploring-chemical-space-ai-take/98/i13 [https://perma.cc/2wtz2mae]. 2023] the safe harbor of 35 u.s.c. § 271(e)(1) 171 under a negotiated licensing agreement, why should companies like allele invest in producing fluorescent proteins capable of accelerating the development of future vaccines? though allele could use the technology internally, allele generates a large part of its revenue from producing and selling cutting edge technology for clinical and therapeutic use and develops an array of research tools.187 a second consequence of limiting enforceability of research tool patents is that fewer patents will be issued on research tools commonly used in generating data for fda approval. this will discourage public disclosure of available technology for research tools and preclude possible advancements thereupon. rather, developers of research tools may elect for keeping trade secrets. protecting the trade secrets may needlessly complicate experiments required to generate data for the fda or limit where the experiments may be conducted. these outcomes would slow the progress of valuable technologies. some may argue an exception should be carved out for the case where a patented research tool is the exclusive option for obtaining specific data required for fda approval. if the holder of the patent on the research tool and the patent on the drug are one and the same, the owner could conceivably delay fda approval by withholding the required patented research tool, thus extending their monopoly. this reasoning is not persuasive and fails to consider existing processes and procedures. such an exception is not required because the research tool may be properly licensed by the generic. if the holder is unwilling, a case for mandatory licensing may be considered under those rare circumstances. nullifying the patent amounts to taking property rights promised by the constitution188 and otherwise does not advance the state of science. iv. conclusion any ambiguity in a statute is properly presumed a legislative failure. as such, the duty to remove alternative readings and denounce misconceived case law rests first with the legislature. adopting symmetric language and definitions between § 156 and § 271 of the act would resolve the ambiguity faced by federal district courts and prospective litigants. while an amendment from the legislature is the preferable solution, the supreme court must not be idle while opposing interpretations leave an issue essentially without law. if the remaining allele case is eventually appealed to the supreme court, the court should enunciate an interpretation of merck and § 271 which explicitly excludes patented inventions not themselves subject to fda approval. the supreme court should clarify that research tools are not within the purview of § 271(e)(1) and clarify that the “product” of §156 has the same scope as the “patented invention” of § 271. while the judiciary is not licensed to write laws, and the nation admires judicial humility, the duty to interpret is of particular 187. second amended complaint at 4, allele biotechnology & pharm., inc. v. regeneron pharm’s, inc., no. 20-cv-08255, 2021 wl 2880694 (s.d.n.y apr. 8, 2021). 188. u.s. const. art. i, § 8 cl. 8. 172 indiana health law review [vol. 20:143 importance when ambiguity has resulted in inconsistent application of the patent laws. poorly worded statutes need not beget murky interpretations. whether a particular use of a patented invention in the united states is patent infringement should not depend on which federal district one lives within. advancing the human right to health: eleanor kinney’s seminal contributions to the development and implementation of human rights for public health benjamin mason meier & lance gable professor eleanor kinney long served as a foundational scholar at the intersection of law and public health, pushing scholarship forward across the fields explored in this special issue. yet, while this special issue is largely confined to the domestic legal space, professor kinney also served as an early and influential scholar on the international human right to health, and this contribution has proven central to the field of health and human rights over the past two decades. having worked alongside professor kinney throughout these years, drawing on her research in framing our own scholarship, it is an honor to reflect on her seminal works that have defined the field and influenced rightsbased health policy – developing the right to health under international law and implementing that right in u.s. health policy. eleanor kinney and the authors at the american public health association annual meeting i. development of the right to health under international law professor kinney was already a leading scholar of u.s. health law and public health law when she sought to advance understanding of the international human right to health. this development of the right to health, bringing together theoretical conceptualization and comparative analysis, provided an early american effort to understand the scope and content of this human right as a framework for public health. 22 indiana health law review [vol. 17:21 a. conceptualizing a human right to health as the co-director of the center for law and health at the indiana university school of law-indianapolis, professor kinney used the inaugural lecture of her samuel r. rosen professorship to frame an international legal mandate for government responsibilities in health, looking to the human right to health as a basis for governmental accountability. where the united nations (un) committee on economic, social and cultural rights (“cescr”) had adopted in 2000 a “general comment” on the content of the right to health under the international covenant on economic, social and cultural rights,1 professor kinney sought to elaborate the meaning of this newly interpreted right. this lecture at the turn of the century, expanded upon and published in 2001 in the indiana law review, provided an early academic examination of the development of the human right to health under international law and offered a forceful argument for its implementation in the united states.2 with the field of health and human rights just coming into focus,3 this early academic effort sought to conceptualize the development of the human right to health under international law.4 although this right had long been dormant in international legal developments throughout the cold war—with the dueling cold war superpowers split on the existence and obligations of economic, social, and cultural rights5—the end of the cold war provided an opening to see the right to health as indivisible from other rights.6 as nations embraced health-related human rights in a post-cold war world, the cescr’s general comment 14 on the right to health established a broad and encompassing view of rights to underlying determinants of health, assessing the realization of these determinants on the basis of their availability, accessibility, acceptability, and quality.7 professor kinney looked to these international legal developments as a foundation for the future of health and human rights, tracing the origins of the right to health from enlightenment thinkers through un treaties. in defining the content of the right to health, she examined the codification of the right to health 1. comm. on econ., soc. & cultural rights, general comment no. 14: right to the highest attainable standard of health (art. 12), u.n. doc. e/c.12/2000/4 (aug. 11, 2000) [hereinafter general comment 14]. 2. eleanor d. kinney, the international human right to health: what does this mean for our nation and world?, 34 ind. l. rev. 1457 (2001). 3. see generally health and human rights: a reader (jonathan m. mann et al. eds. 1999). 4. kinney would go on to work with ethicists to clarify the non-legal “foundation for a natural right to health care.” see generally jason eberl, eleanor kinney & matthew williams, foundation for a natural right to health care, 36 j. med. & phil. 537 (2011). 5. see generally stephen p. marks, the past and future of the separation of human rights into categories, 24 md. j. int’l l. 209 (2009). 6. world conference on human rights, vienna declaration and programme of action, ¶ 5, u.n. doc. a/conf.157/23 (june 25,1993). 7. general comment 14, supra note 1, at 4-5. 2020] advancing the human right to health 23 under international treaties, recognizing that the united states had not ratified many of these international human rights treaties but noting that customary international law (based on existing treaty ratifications and national laws) could fill these legal gaps to implement the right to health in u.s. policy. the implementation of this right—in the united states and beyond—would serve as a basis to refine the normative content of the right to health through national practice. yet, this focus on national practice would require attention to national health resources. reflecting on the “principle of progressive realization” under international law,8 professor kinney conceptualized the obligations of the right to health “on a continuum” – contingent upon the resources and cultures of individual countries.9 this continuum of obligations would require clarification to support states in their interpretation, implementation, and enforcement of the right to health at various stages of development. in assuring accountability for these implementation efforts, professor kinney quickly recognized that the judiciary would not be central to the enforcement of progressive realization, looking beyond these “legalistic visions”10 to assure the maximum available resources for health through legislative processes. such accountability for health could be structured through measurement, assessing “indicators” of human rights realization and comparing these indicators – across national public health outcomes, in the work of international lending institutions, and through implementation measures in national law. b. comparative analysis across countries this focus on national law would be taken up in the first cross-national examination of legal provisions for health and health care across all the countries of the world. through professor kinney’s empirical research on national laws, this study would be explicitly framed to assess human rights implementation, opening with the statement: “[a]t a time of renewed interest in the international human right to health, it is useful to identify and examine the provisions of the constitutions of the world regarding health and health care.”11 having focused 8. under the “principle of progressive realization,” codified in the icescr, a state is only obligated to: “take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present covenant by all appropriate means, including particularly the adoption of legislative measures” (emphasis added) g.a. res. 2200a (xxi), international covenant on economic, social & cultural rights, art. 2 (dec. 16, 1996). as the cescr has noted, the principle of progressive realization is a recognition that the full realization of economic, social, and cultural rights will be dependent on resources and that states will differ in their realization of rights based upon those resources. comm. on econ., soc. & cultural rights, general comment no. 3: the nature of states parties obligations, ¶ 9, u.n. doc. e/1991/23 (1991). 9. kinney, supra note 2, at 1457. 10. id. at 1467. 11. eleanor d. kinney & brian alexander clark, provisions for health and health care in 24 indiana health law review [vol. 17:21 previously on the importance of national constitutions to the development and implementation of the right to health, professor kinney recognized how these national constitutions had increasingly established health-related obligations—especially those constitutions developed since the end of world war ii—drawing from international human rights standards in their domestic rights elaboration.12 the study of these national constitutions would mark an early effort to bring empirical research methods into legal research on the right to health. professor kinney described this research in the manner of a scientific research paper—including tables and graphs in a law review publication—with a methods section that elucidated the procedures taken in her analytic coding study: narrowing the constitutions in her sample and categorizing the types of constitutional provisions that address health.13 categorizing these constitutional provisions provided professor kinney with a basis to give meaning to the right to health and to assess the influence of constitutional protections on indicators of health sector performance.14 this empirical coding at the intersection of health and human rights would soon become a model for research on rights-based national laws,15 human rights litigation,16 and human rights treaty bodies.17 professor kinney argued that the constitutional codification of health and health care obligations reflects an explicit government commitment to implement the international human right to health. however, while professor kinney found that over two-thirds of constitutions have expressed a national commitment to health, she nevertheless concluded that “the national commitment to health and health care is not highly related to whether or not a nation’s constitution specifically addresses health or health care.”18 this conclusion, highlighting a the constitutions of the countries of the world, 37 cornell int’l l.j. 285, 285 (2004). 12. id. at 291-93, 296-97. 13. id. at 289-90. 14. id. at 301 (recognizing that “policy imperatives created by constitutional provisions and international human rights treaties can be used as standards for the evaluation of government’s performance with respect to the realization of economic and social human rights”). 15. see jody heymann et al., constitutional rights to health, public health and medical care: the status of health protections in 191 countries, 8 glob. pub. health 639, 641 (2013) (“in order to obtain the information on health rights necessary for this study, a coding team fluent in several official un languages reviewed the constitutions of 191 un member states as amended to two points in time: august 2007 and june 2011.”). 16. see generally colleen m. flood & aeyal gross, litigating the right to health: what can we learn from a comparative law and health care systems approach?, 16 health & hum. rts. j. 62 (2014). 17. benjamin mason meier, marlous de milliano, averi chakrabarti & yuna kim, accountability for the human right to health through treaty monitoring: human rights treaty bodies & the influence of concluding observations, 13 glob. pub. health 1558, 1562-64 (2018) (describing the coding methodology employed to analyze the content of state reporting on the right to health and concluding observations of the cescr). 18. kinney & clark, supra note 11, at 287. this counterintuitive conclusion reflects the fact 2020] advancing the human right to health 25 weakness in the causal chain linking the state ratification of international treaties with the lived experience of public health, would frame a new comparative research agenda on the human rights implementation process.19 (this imperative to understand human rights implementation would lead future researchers to investigate the country-specific processes by which human rights are translated from international ratification to national implementation.20) with this new understanding of right to health implementation in national laws throughout the world, professor kinney would return her focus home, examining the implementation of the right to health in u.s. health care policy. c. application to the united states the political acceptance and policy implementation of the right to health remained uncertain in the united states, leaving it as the only developed nation without policies to realize universal health coverage. although the u.s. government played a key role in the early development of the right to health under international law,21 it had long faltered in the implementation of these rights-based norms through u.s. health care policy.22 as other nations moved to establish universal health care systems, the expanding u.s. system of private employer-sponsored insurance and the strident opposition of the american medical association repeatedly blunted calls for sweeping government action.23 yet, despite the failure of these early efforts to bring about universal health care, such rights-based advocacy spurred incremental efforts to expand government involvement in health care in the united states—universal access to emergency care, coverage for the needs of the elderly and indigent, and access to basic services for children—offering evolving government recognition of rights-based obligations for the health of the most vulnerable members of society.24 however, these increasingly expansive efforts failed to codify a universal right to comprehensive health care. that “the most resounding constitutional commitments to health and health care are in poor countries with tenuous democracies.” id. at 294. 19. id. at 298. 20. gillian macnaughton & angela duger, translating international law into domestic law, policy, and practice, in foundations of global health & human rights (lawrence o. gostin & benjamin mason meier eds., forthcoming 2020). 21. see benjamin mason meier, global health governance and the contentious politics of human rights: mainstreaming the right to health for public health advancement, 46 stan. j. int’l law 1, 3-5 (2010). 22. anja rudiger & benjamin mason meier, a rights-based approach to health care reform, in rights based approaches to public health 69, 72-73 (elvira beracochea et al. eds., 2010). 23. see anne-emmanuelle birn et al., struggles for national health reform in the united states, 93 am. j. pub. health 86 (2003). 24. benjamin mason meier & lance gable, us efforts to realise the right to health through the patient protection and affordable care act, 13 hum. rts. l. rev. 167, 168-73 (2013). 26 indiana health law review [vol. 17:21 corresponding with international law, professor kinney found a right to health care to exist as a “statutory right” under u.s. law, framed by domestic legislation that had progressively realized access to health care in the united states. professor kinney’s analysis would arrive just as a debate was beginning on what would become the largest leap forward in realizing the right to health through u.s. law – the 2010 patient protection and affordable care act (“affordable care act” or “aca”).25 presidential candidate barack obama was asked for the first time in the debates preceding the 2008 u.s. elections whether health care is a human right. focusing on inequities in insurance coverage, obama responded: i think it [health care] should be a right for every american. in a country as wealthy as ours, for us to have people who are going bankrupt because they can’t pay their medical bills – for my mother to die of cancer at the age of 53 and have to spend the last months of her life in the hospital room arguing with insurance companies because they’re saying that this may be a pre-existing condition and they don’t have to pay her treatment, there’s something fundamentally wrong about that.26 in meeting the government’s obligation to secure the health of every american, the affordable care act would draw on the “internationally recognized conception of a human right to health, seeking to progressively realize the highest attainable standard of physical and mental health through policies that ensure the availability, accessibility, acceptability, and quality of health care.”27 ii. implementation of the right to health under u.s. policy while others had begun to examine the right to health, professor kinney recognized that the weakness of this right extended to its implementation in the united states: u.s. health policy makers do not look to international human rights law for mandates or guidance when it comes to domestic health policy. in fact, it would probably surprise many u.s. health policy makers that a body of international law exists that has concrete implications for domestic policy making regarding health.28 raising an imperative to implement the right to health in u.s. policy, professor kinney continued to expand her scholarship on the recognition and implementation of the right to health by addressing aspects of this right in the 25. patient protection and affordable care act, 42 u.s.c. § 18001 (2010). 26. october 7, 2008 debate transcript, comm’n on presidential debates (oct. 7, 2008), https://www.debates.org/voter-education/debate-transcripts/october-7-2008-debate-transcrip/ [https://perma.cc/7b7l-73mv]. 27. meier & gable, supra note 24, at 167. 28. kinney, supra note 2, at 1458. 2020] advancing the human right to health 27 united states. her scholarship sought to implement the right to health under u.s. law and presciently highlighted areas—including international trade, for-profit insurance, and immigrant health—where the limited application of the right to health in u.s. law has continued to imperil the public’s health. a. recognition of the right to health in the united states professor kinney began to lay the foundations for u.s. health policy reforms in 2008 with her development of a far-reaching analysis on the recognition of the right to health in various aspects of u.s. law. as a natural extension of her work on the right to health under international law, professor kinney chronicled the many areas in which the united states fell far below other high-income countries in health indicators in spite of far larger per capita expenditures on health. she acknowledged that structural impediments within the united states prevented an explicit analysis of u.s. obligations under the right to health with limited recognition of the right to health in the u.s. constitution and forestalled ratification of international human rights treaties that include the right to health. yet, despite these limitations, she observed that the united states could nevertheless realize many aspects of the right to health through statutory and regulatory means, finding that “express recognition of the international human right to health in a constitution is by no means essential to achieve national recognition.”29 professor kinney articulated a clear connection between her scholarship on the u.s. health care system and the international human right to health by demonstrating both the deficiencies in u.s. health policies that undermine the right to health and the opportunities to remedy these shortcomings through legislative reforms. in doing so, she outlined a series of recommendations to realize the right to health in the united states, including formal ratification of international human rights treaties that include the right to health and modification of domestic health care policies that could effectively implement the right to health even without formal treaty recognition. drawing from professor kinney’s scholarship, the aca would create a framework for health care reforms in the united states and a model for realizing universal health coverage pursuant to the right to health – even without formally recognizing the right.30 as argued by professor kinney, the enactment of the aca moved the united states closer to realizing many aspects of the right to health. when the u.s. government reported on its human rights obligations before the u.n. human rights council’s universal periodic review, this 2011 u.s. report heralded the promulgation of the aca as a foundation for realizing the right to health: the act [aca] makes great strides toward the goal that all americans 29. eleanor d. kinney, recognition of the international human right to health and health care in the united states, 60 rutgers l. rev. 335, 364 (2008). 30. lance gable, the patient protection and affordable care act, public health, and the elusive target of human rights, 39 j. l. med. & ethics 340 (2011). 28 indiana health law review [vol. 17:21 have access to quality, affordable health care. the law is projected to expand health insurance coverage to 32 million americans who would otherwise lack health insurance, significantly reduces disparities in accessing high-quality care, and includes substantial new investments in prevention and wellness activities to improve public health.31 however, absent formal recognition of a right to health under u.s. law, these statutory gains have remained susceptible to future revocation through executive orders, legislative repeals, and judicial challenges, leaving an uncertain future for health and human rights in the united states.32 b. trade in an economically integrated north america focusing additionally on the implications of international trade agreements for implementing the right to health in the united states, professor kinney examined the historic changes ushered in by the north american free trade agreement (nafta). this analysis, published just at debates were beginning on the aca, served not only as an opportunity to highlight the deficiencies of the u.s. health system in upholding the right to health, but also as a platform for comparative analysis of the respective health systems in the united states, canada, and mexico.33 nafta’s lowering of trade and commercial barriers between countries (with vastly different health insurance and delivery systems) raised concerns that private entities would seek to undermine the government health care systems in place in canada and mexico. professor kinney’s analysis articulated a clear assessment of some of the unresolved health policy questions raised by nafta, including whether forprofit business interests would be able to use nafta to challenge public benefits systems and whether individuals would still receive health insurance coverage while in neighboring countries.34 examining the possibility that the provision of health care by the private sector could violate the right to health, professor kinney proposed an explicit limitation on such efforts: “[p]rivate insurers and for-profit providers should not be able to profit from the care of the healthy and wealthy in ways that compromise the viability of public programs that serve the 31. human rights council, national report submitted in accordance with paragraph 15 (a) of the annex to human rights council resolution 5/1, ¶ 70, u.n. doc. a/hrc/wg.6/9/usa/1 (aug. 23, 2010). 32. see meier & gable, supra note 24. 33. see generally eleanor d. kinney, health care financing and delivery in the united states, mexico, and canada: establishing intentional principles for sound integration, 26 wis. int’l l. j. 934 (2009). this comparative analysis of the right to health across the united states, canada, and mexico related to professor kinney’s earlier comparative work on the right to health. see kinney & clark, supra note 11. see also lance gable, brooke courtney, robert gatter & eleanor d. kinney, global public health legal responses to h1n1, 39 j.l. med. & ethics 46 (2011) (extending professor kinney’s focus on health challenges in mexico). 34. eleanor d. kinney, realization of the international human right to health in an economically integrated north america, 37 j.l. med. & ethics 807, 812-13 (2009). 2020] advancing the human right to health 29 poor and seriously ill.”35 she also suggested that the nafta framework could be used to expand health insurance coverage for those traveling between countries, noting that “[m]uch could be done if public and private health insurance on the continent were more portable and the coverage was available regardless of immigrant status.”36 these proposals, coming on the cusp of the passage of the aca, would prove influential in the years that followed. although attempts by private health care entities to challenge the validity of canada’s government health insurance system were dismissed,37 many of the other issues highlighted by professor kinney remain unresolved. as the countries of north america continue to integrate economically under new international trade agreements, regulating trade in ways that may undercut health and human rights, the public health impact of these policies must be taken into account in protecting human rights from violation by the for-profit health care system.38 c. the challenge of for-profit health care flowing from her critique of free trade agreements, professor kinney sought to address the complex issue of how to reconcile the for-profit health care model in the united states with the realization of the international human right to health. while the provision of health care through the private sector has a major role in the health systems of many countries, human rights treaties that codify government obligations under the right to health do not address the private sector.39 however, profit motives pursued by private-sector entities may conflict with or undermine the realization of the right to health. professor kinney’s concerns about the continued influence of for-profit entities on the realization of the right to health invoked a timely warning as the u.s. congress was debating the aca. although the final aca expanded health insurance coverage through significant regulations on for-profit health insurers, congressional debates ultimately rejected proposals that would have presented government competition to private health insurers – a so-called “public option” that would have made the government directly responsible for assuring access to health care. professor kinney recognized the failure of private markets as an imperative for government initiatives to realize the right to health. she found that “[p]rivate competitive markets for health care, in particular, have proven unable to provide 35. id. at 813. 36. id. 37. gov’t of can., centurion health corp. v. government of canada, glob. affairs can. (dec. 12, 2017), https://www.international.gc.ca/trade-agreements-accords-commerciaux/topicsdomaines/disp-diff/centurion.aspx?lang=eng [https://perma.cc/sc95-kb67]. 38. see generally ronald labonte et al., usmca (natfa 2.0): tightening the constraints on the right to regulate for public health, 15 globalization & health 35 (2019). 39. see generally m. gregg bloche, is privatisation of health care a human rights problem?, in privatisation and human rights in the age of globalisation 207 (koen de feyter & felipe gümez isa eds., 2005). 30 indiana health law review [vol. 17:21 affordable and high quality health care for all people. throughout the world, governments have assumed part of the burden of providing or financing health care services for their populations.”40 to alleviate these threats to health from the private sector, professor kinney proposed incorporating specific provisions in trade agreements to allow countries to protect public health care systems from private competitors, take measures to limit profit-seeking in the health care sector, and expand “universal access to affordable and portable health coverage.”41 further, with skilled health care professionals lured away from low-income countries to serve more lucrative for-profit systems in the global north, professor kinney concluded that trade agreements should incentivize strategies to backfill these positions and support educational institutions in the countries that are experiencing shortages of human resources and health expertise. finally, professor kinney recommended additional efforts to ensure that low-income countries have access to essential medicines despite international trade protections for intellectual property, looking to the right to health to prioritize public health over patent protections.42 while the subsequent implementation of the aca has expanded access to health insurance and health care, private-sector health care entities have retained their power and privilege within the u.s. health care system, leaving many of the concerns raised by professor kinney to persist. as a result, the trends of privatization and financialization of health care insurance and services have continued in the united states, often to the detriment of stable health care programs, as private competitors siphon off customers and increase costs within the health care system. moreover, as right-leaning governments and austerity policies have depleted the public sector, with populist governance rejecting universal rights as a foundation for health, the conflicting motives of for-profit entities and the right to health continue to manifest in countries around the world.43 the rights-based promise of professor kinney’s ideas have yet to be realized in assuring universal health coverage. d. realizing health for non-citizens in protecting the most vulnerable through the right to health, professor kinney sought to link the right to health to the treatment of immigrants – in the united states and throughout the world. while the aca represented a significant 40. eleanor d. kinney, realizing the international right to health: the challenge of forprofit health care, 113 w. va. l. rev. 49, 59 (2010). 41. id. at 66. 42. this argument served to support others in the health and human rights movement who were looking to implement a human right to essential medicines, challenging the international patent regime to assure compulsory licensing of pharmaceutical patents in the context of a public health emergency. see lisa forman, trade rules, intellectual property, and the right to health, 21 ethics & int’l aff. 337 (2007). 43. see audrey chapman, the impact of reliance on private sector health services on the right to health, 16 health & hum. rts. j. 122 (2014). 2020] advancing the human right to health 31 step in the progressive realization of the right to health in the united states, noncitizens were explicitly excluded from aca provisions that expanded access to health insurance.44 professor kinney expertly navigated the complicated landscape of non-citizen eligibility for u.s. federal health programs and private insurance, drawing on the right to health to call attention to the substantial gaps and inconsistencies in access to health insurance and health care for immigrants. professor kinney’s forward-looking analysis provided several practical yet aspirational recommendations to expand health insurance to non-citizens and move law and policy into alignment with the right to health.45 citing examples from the european union’s policies on cross-border health insurance reciprocity, she urged the three largest north american countries, already bound together by nafta, to extend the portability of health insurance to non-citizens in their respective countries.46 she also cited approvingly to proposals that would allow the same sort of cross-border reciprocity in the private health insurance market.47 in clearly recognizing the universality of human rights and the interconnectedness of the right to health with immigration and trade law, professor kinney proved once again that her insights ran well ahead of her contemporaries. in so doing, she articulated the importance of migrant health in realizing the right to health, presaging more recent global debates on the rights of non-citizens to health care under international human rights norms.48 her recognition of the inherent disparities in health care access faced by noncitizens—due to the public charge rule in the united states—also predicted the contemporary legal challenges to current u.s. policies to prevent documented immigrants from accessing public insurance programs.49 these efforts to protect the health of those who lack legal status but have human rights continues to be an urgent necessity in u.s. policy and global governance.50 44. see patient protection and affordable care act, 42 u.s.c.a. §18032(f)(3) (2010). see also helen b. marrow & tiffany d. joseph, excluded and frozen out: unauthorised immigrants’ (non)access to care after us health care reform, 41 j. ethnic & migration stud. 2253 (2015). 45. eleanor d. kinney, realizing the international human right to health for non-citizens in the united states, 1 notre dame j. int’l comp. & hum. rts. l. 94, 112-13 (2011). 46. id. at 109–12. 47. see nathan cortez, embracing the new geography of health care: a novel way to cover those left out of health reform, 84 s. cal. l. rev. 859 (2010-2011). 48. see kristine husøy onarheim, andrea melberg, benjamin mason meier & ingrid miljeteig, towards universal health coverage: including undocumented migrants, bmj global health (oct. 8, 2018) https://gh.bmj.com/content/3/5/e001031?utm_campaign=bmjgh&utm_ content=consumer&utm_medium=cpc&utm_source=trendmd&utm_term=1-a#block-system-main [https://perma.cc/cy6w-55w7]. 49. see wendy e. parmet, the trump administration’s new public charge rule: implications for health care and public health, health aff. (aug. 13, 2019) https://www.healthaffairs.org/do/10.1377/hblog20190813.84831/full/ [https://perma.cc/mh3d5nht]. 50. see int’l org. for migration (iom), international organization for migration, migration and the right to health: a review of international law (2013) 32 indiana health law review [vol. 17:21 iii. conclusion through her important scholarly contributions to the field of health law, professor eleanor kinney’s research has proven influential in academic discourse and policy debates, with this engaged scholarship serving as an inspiration to the field and a framework for policy. her tireless devotion and thoughtful insights have provided unique perspectives, supported by rigorous research and innovative thought, on the development and implementation of the human right to health. in reflecting on her legacy, we recognize professor kinney’s enduring contributions to the intersection of health law and human rights, which were not only ahead of her time in understanding the importance of international law, but also continue to have relevance in these uncertain times for the realization of health and human rights in the united states. https://publications.iom.int/system/files/pdf/iom_unhchr_en_web.pdf [https://perma.cc/58ejcpxk]; int’l org. for migration (iom), migration and the right to health: a review of international law (2009) https://publications.iom.int/system/files/pdf/iml_19.pdf [https://perma.cc/mc7u-efjq]. indiana health law review, vol stop playing through it: why indiana needs to reassess its stance towards brain injuries and its current concussion protocol in high school sports joshua piercey* i. introduction junior seau, one of the national football league’s most feared and talented defensive linebackers, was known for his toughness and his ability to play through pain.1 during a stint towards the end of his career with the new england patriots, seau suffered a fractured hand, and when the trainer asked about xraying his hand and removing him from the game, he responded, “[w]hy? i know it’s broke. we don’t need to x-ray it.”2 not surprisingly, seau went on to finish the game.3 it was this sort of tenacious dedication to the game that painted his legacy as a legendary linebacker, but his biggest and most lasting contribution to football may not have even come until after his career was finished.4 at the age of 43, after a 13-year nfl career, seau was found dead in his home from self-inflicted gunshot wounds.5 after being questioned about her son’s tragic passing, seau’s mother cried out to reporters, “i don’t understand . . . i am shocked.”6 his death was a shock to all and left many wondering what may have caused him to take his own life.7 reporters believed this tragedy was a result of his ongoing battle with depression, and some believed that his recent divorce might have been the inciting incident that caused him to take his own life. his family believed there was more to it, and they were confident that his time playing in the nfl might have heavily contributed to his depressed state.8 in the search for truth, the seau family decided to donate his brain to neuroscientists at the national institute for health in order to research whether or not extensive blows to the head that seau sustained while playing in the nfl might uncover some truth about his mental health.9 * j.d. candidate, 2020, indiana university school of law indianapolis; b.a., 2016, wabash college. 1. jim trotter, junior seau: playing through pain, espn (nov. 19, 2015), http://www.espn.com/nfl/story/_/page/hotread151119/legendary-linebacker-junior-seau-routinelyplayed-pain-nfl [https://perma.cc/h2fa-hhmy]. 2. id. 3. id. 4. id. 5. junior seau dies at 43, espn (may 2, 2012), https://www.espn.com/nfl/story/_/id/ 7882750/jun ior-seau-former-san -d iego-ch arger -found-dead-cops-probe-su icide [https://perma.cc/va8h-b5d4]. 6. id. 7. id. 8. id. 9. id. 314 indiana health law review [vol. 17:313 after several months of analysis, the team of researchers came to the conclusion that seau had suffered from chronic traumatic encephalopathy, commonly known as cte, at the time of his death.10 this “brain disease” is a direct result of continual concussions or head trauma, and unfortunately can only be diagnosed post mortem.11 so, the unfortunate answer that the seau family was looking for could only be known after his passing.12 but, who is to blame? is it the manufacturers of the safety equipment used by players? is it the players themselves, or is it the game? some might think that tragic deaths like seau’s are more likely to happen as a result of grown men violently sacrificing their bodies playing the sport they love; however, head injuries and resulting tragic deaths can be seen in all ages.13 it was a regular friday night under the lights in georgia as parents, friends, and fans packed the stands to watch their sons, classmates, and associates compete against each other in america’s fall ritual . . . high school football.14 the game was going smoothly until dylan thomas, a junior, removed himself from the competition.15 as he walked towards the sidelines, his teammates could tell that something was wrong with him, and once he reached the trainers, he collapsed.16 when he woke up, he said “i can’t feel my body.”17 the medical staff rushed him to the hospital.18 dylan was officially pronounced dead just two days after collapsing on his high school field.19 the coroner’s office determined that the death was caused by “cardiac arrest from his head trauma.”20 after analyzing his records and reviewing the incident, the doctors ultimately viewed his death as an “anomaly” explaining that it must have taken a “perfect hit” to his brain to 10. mark fainaru-wada & steve fainaru, doctors: junior seau's brain had cte, espn (jan. 9, 2013), https://www.espn.com/espn/otl/story/_/id/8830344/study-junior-seau-brain-showschronic-brain-damage-found-other-nfl-football-players [https://perma.cc/k78q-2s2n] 11. ovidiu chiroban & lãcrãmioara perju-dumbravã, postmortem evaluation of chronic traumatic encephalopathy, 24 rom. j. of legal med. 266 (2016). 12. junior seau dies at 43, supra note 5. 13. see what is cte?, concussion legacy found., https://concussionfoundation.org/cteresources/what-is-cte [https://perma.cc/3pee-vu8j]. 14. marlena baldacci, devon m. sayers & eric levenson, georgia high school football player said, 'i can't feel my body,' then died. but why?, cnn (oct. 2, 2018), https://www.cnn. com/2018/10/01/health/georgia-high-school-football-player-dies/index.html [https://perma. cc/vf8g-kj2d]. 15. see id. 16. id. 17. id. 18. id. 19. id. 20. joelle goldstein, high school football player who died after game suffered cardiac arrest caused by a head injury, people.com (oct. 9, 2018), https://people.com/sports/georgiahigh-school-football-player-dylan-thomas-suffered-cardiac-arrest-from-head-injury/ [https://perma.cc/k4yf-s3ua]. 2020] stop playing through it 315 force his body to go into cardiac arrest.21 after a few weeks without obtaining any definitive answers and still baffled by the “anomaly” explanation for dylan’s death, georgia authorities decided to review the game footage to see whether or not dylan did in fact sustain a head injury or a blunt negligent hit to the head, or any other contact to his head, by the opposing team or by his own teammates.22 upon watching the footage, there was not a single incident that showed him receiving a traumatic hit in the head.23 while the issues that need to be addressed are not strictly exclusive to football, as brain injuries are a commonality in almost every sport, these two distinctly different, but eerily similar, stories bring to light a shared issue that direly needs to be addressed regarding the safety of playing football. the big question that needs to be answered is whether or not we, as a society, are willing to rectify our recent past blind-eyed ignorance towards awareness of head trauma in football and move forward to take the proper steps to make an already dangerous sport safer at all playable levels. there used to be a train of thought that it was less likely to have a concussion or brain injury as young athlete because the pace and speed of play by younger athletes was not as quick as individuals who play collegiately or professionally; however, contrary to this belief, the likelihood to sustain a brain injury is not correlated to age level, as concussions and other head injuries can be sustained at almost any level of a sport.24 dr. henry feuer, a practicing neurosurgeon and member of the national football league’s head, neck, and spine medical subcommittee, commented on this issue of concussions and how they are affecting all ages by stating, “[t]he kids we’re talking about, middle school, high school, they’re more vulnerable than the pros.”25 so if kids are more vulnerable to head injuries, are we wrongfully cultivating a culture of “play through the pain” in our youth? what if playing through the pain means putting your own life at risk? do we, as a state, have a proper protocol setup for our high school athletes to keep them as safe as possible while playing? where should we as a state look to adopt a brain-trauma protocol that will keep our high school athletes as safe as possible? the nfl has gone through rigorous criticism regarding their historic protocols in hopes of finding the best possible way to prevent permanent brain injuries.26 should the ihsaa and other affiliated groups involved with players’ safety in indiana 21. id. 22. id. 23. id. 24. see football can damage kids' brains — even if they don't get concussions, wbur (sept. 19, 2017), https://www.wbur.org/hereandnow/2017/09/19/youth-footballconcussions [https://perma.cc/2h55-czs9]. 25. indiana mandates concussion training for public coaches, chi. trib. (apr. 3, 2016), http://www.chicagotribune.com/news/nationworld/midwest/ct-indiana-concussion-training20160403-story.html [https://perma.cc/3vuy-quq9] (internal quotation marks omitted.) 26. see agence france-presse, n.f.l. changes concussion protocol, n.y. times (dec. 24, 2017), https://www.nytimes.com/2017/12/24/sports/football/nfl-concussion-protocol.html [https://perma.cc/48qm-zqs9]. 316 indiana health law review [vol. 17:313 follow the nfl, or is there a better protocol out there?27 a. map of review part i of this note will discuss concussions from a scientific and medical perspective, providing an explanation of what a concussion is, including a medical definition of concussion, diagnosis and grading of concussions, as well as an explanation of the common symptoms and resulting medical outcomes expected for someone who has sustained a concussion. it will also provide the long-term effects of sustaining a concussion, such as the possibility to develop cte, as well as provide statistical data showing the dangers of sustaining a concussion at a young age. part ii of this law review will offer an assessment of the nfl’s current concussion protocol and explain how it has changed over the years, as well as compare its protocol to the ufc’s current concussion protocol to see if there are any major differences between the two. part iii will review indiana’s current concussion protocol established for high school sports to see how it compares to the professional ones reviewed in the note, as well as explain why it is important to regulate state laws and rules to make the prospective games safer. lastly, this review will call for a change to some of the current rules and laws established in indiana regarding head trauma in high school sports. ii. part i: a medical overview of concussions although there is much uncertainty about what a concussion is, most medical practitioners agree that, “[a] concussion is a type of traumatic brain injury–or tbi–caused by a bump, blow, or jolt to the head or by a hit to the body that causes the head and brain to move rapidly back and forth.”28 these rapid movements, resulting from direct contact to the head, make the actual brain itself jerk and jolt around inside the skull, and when this occurs it sometimes causes the brain to twist inside the skull.29 these rapid movements and the possible twisting of the brain creates drastic changes in the chemical makeup of the brain and can cause severe cell damage to the brain cells altogether.30 historically, these concussions have been considered “mild brain injur[ies]” by neuroscientists, and some even today still consider them as such, but concussions can be serious if not treated properly, and if left untreated, they can result in death.31 now that the basics of what a concussion is has been explained, it is imperative to look at the many types of concussions and what causes them and the symptoms that are tied 27. see marissa payne, ufc ceo lorenzo fertitta outlines why his concussion protocol is better than the nfl's, wash. post (jan. 15, 2015), https://www.washingtonpost.com/news/ early-lead/wp/2015/01/15/ufc-ceo-lorenzo-fertitta-outlines-why-his-concussion-protocol-is-betterthan-the-nfls/?noredirect=on&utm_term=.7ab715875e72 [https://perma.cc/4h43-bm2d]. 28. what is a concussion?, ctrs. for disease control & prevention, https://www.cdc. gov/headsup/basics/concussion_whatis.html [https://perma.cc/b2nl-lh87]. 29. id. 30. id. 31. see id. (internal quotation marks omitted). 2020] stop playing through it 317 to the injury.32 concussions can be caused by a variety of actions, but specifically in football, they are normally caused by violent contact to the crown of the head as a result of a collision of two players.33 it is even possible for the constant contact between an offensive lineman and a defensive lineman to cause a player to experience a concussion.34 in some cases, players can even experience concussions as a result of their head hitting the ground, with the resulting impact causing the brain to reverberate inside the skull.35 the symptoms of a concussion, while normally similar with each case, come in an extreme variety.36 the immediate signs of a concussion are extremely subtle and sometimes hard to detect. some prominent symptoms include but are not limited to: loss of memory (usually forgetting the event that caused the concussion) and confusion, headache or pressure in the head, temporary loss of consciousness, confusion or feeling as if in a fog, amnesia surrounding the traumatic event, dizziness or seeing stars, ringing in the ears, nausea, vomiting, slurred speech, delayed response to questions, appearing dazed, and fatigue.37 along with the symptoms that show up as soon as the head trauma happens, or if not immediately after, there are a few symptoms that are delayed and show up some time after the incident occurs.38 these delayed symptoms include: concentration or memory complaints, irritability and other personality changes, sensitivity to light and noises, sleep disturbances, psychological adjustment problems, depression, and disorders of taste and smell.39 neurologists and doctors also break concussions into type and severity, or “grade.”40 they generally grade these concussions based off of severity and they are split into three specific grades.41 a grade 1 concussion consists of: “transient confusion, no loss of consciousness, and a resolution of mental-status abnormalities in less than 15 minutes.”42 a grade 2 concussion consists of: “no loss of consciousness; concussions symptoms or mental abnormalities with 32. id. 33. see christine m. baugh et al., frequency of head-impact–related outcomes by position in ncaa division i collegiate football players, 32 j. neurotrauma 314 (2015). 34. steven p. broglio et al., cumulative head impact burden in high school football, 28 j. neurotrauma 2069, 2070, 2073 (2011). 35. roy j. shephard et al., yearbook of sports medicine 2011, 20–22 (2011). 36. what is a concussion?, supra note 28. 37. concussion signs and symptoms, ctrs. for disease control & prevention, https://www.cdc.gov/headsup/basics/concussion_symptoms.html [https://perma.cc/5qjy-536d]. 38. id. 39. concussion, mayo clinic, https://www.mayoclinic.org/diseases-conditions/concussion/ symptoms-causes/syc-20355594 [https://perma.cc/9wf6-sv3t]. 40. concussion (traumatic brain injury) webmd, https://www.webmd.com/brain/ concussion-traumatic-brain-injury-symptoms-causes-treatments#2 [https://perma.cc/sus7-lgss] 41. id. 42. roberto masferrer et al., grading scale for cerebral concussions, 16 barrow q. (2000). 318 indiana health law review [vol. 17:313 amnesia for longer than 15 minutes.”43 lastly, a grade 3 concussion consists of “any loss of consciousness whether it is brief or prolonged.”44 from the neurologists grading scale, it is obvious that it is worse to have a grade 3 concussion as opposed to a grade 1, but even medical personnel have a difficult time labeling concussions because the “biomechanical forces that are associated with blows to the head produce different injury presentations in different people.”45 andrew gregory, also commenting on the difficulty of grading concussions stated, “[w]e’ve learned that each concussion acts differently, so trying to use a template just doesn’t work for individual patients . . . [u]sually it’s only in retrospect that you can say how severe a concussion actually is.”46 with the understanding that concussions are difficult to label and sometimes as equally difficult to diagnose, it brings to light the rather frightening conclusions that many players may experience undiagnosed concussions, play while currently having a concussion, or try to hide symptoms of a concussion in efforts to stay in a game or play the ensuing week, which ultimately does nothing but add detrimental effects to the already dangerous epidemic of the sport.47 there are often instances where a player will play through a concussion without even knowing or play before it has fully healed, because the player may not be able to make the causal link between the symptoms they are experiencing to the injury.48 so, what does happen if a person experiences continual concussions or keeps playing a sport before concussion is properly healed? there are many consequences that are a result of an athlete who continues to play with a concussion.49 one issue that athletes who experience concussions deal with is a condition called sis, or second impact syndrome.50 sis is what scientists claim occurs when an athlete experiences a concussion when the symptoms of a previous concussion have not subsided.51 it is also known that a person who experiences sis may be prone to the condition without even experiencing a previous concussion, and in fact there are many cases where a person can acquire 43. id. 44. id. 45. stacey colino, the challenges of gauging concussion severity, everyday health (mar. 14, 2018), https://www.everydayhealth.com/neurology/challenges-gauging-concussionseverity/ [https://perma.cc/ut7v-75a6]. 46. id. 47. associated press, players still willing to hide head injuries, espn (dec. 5, 2011), http://www.espn.com/nfl/story/_/id/7388074/nfl-players-say-hiding-concussions-option [https://perma.cc/cbx5-jgy2]. 48. patrick sullivan, could you have a concussion and not know it?, sharecare, https://www.sharecare.com/health/brain-nervous-system/article/could-you-have-concussion [https://perma.cc/ghc7-ndvx]. 49. see id. 50. terry zeigler, second impact syndrome, sportsmed.com, https://www.sportsmd.com/ concussions-head-injuries/second-impact-syndrome/ [https://perma.cc/r64n-bmrz]. 51. id. 2020] stop playing through it 319 sis only through minor contact.52 even these minor impacts are able to cause the head to snap and “impart[] accelerative forces to the brain.”53 sis carries the same post-concussion symptoms as a normal concussion would, but these symptoms will normally be more reflective of a grade one concussion.54 however, within fifteen seconds to several minutes after the second impact, an individual will collapse with rapidly dilating pupils, loss of eye movement, and respiratory failure.55 studies suggest that “[o]nce a player has incurred an initial cerebral concussion, his or her chances of incurring a second one are three to six times greater than for an athlete who has never sustained a concussion.”56 a great deal of literature now suggests that continual head trauma and concussions can leave people at great risk to develop chronic traumatic encephalopathy or cte.57 this severe brain disease is a result of repeated blows to the head and linked to the onset of dementia.58 similar to graded concussions and sis, people who experience chronic traumatic encephalopathy are diagnosed through symptoms.59 some symptoms commonly related to cte include: memory loss, confusion, personality changes (including depression and suicidal thoughts), erratic behavior (including aggression), problems paying attention and organizing thoughts, and difficulty with balance and motor skill.60 the unfortunate part of cte is that these symptoms may not occur in those inflicted with this condition until years or even decades after the actual brain injury occurs.61 even worse, there is no possible way to pin point someone who is suffering with cte, seeing that those afflicted with cte cannot be diagnosed as having cte until after death.62 research suggests that there is no definitive type of head trauma one experiences that causes an automatic diagnosis of cte as well as the fact that there is no evidence to prove that a single concussion increases the risk of cte.63 however, it is widely accepted that a number of traumatic blows to the head 52. id. 53. robert c. cantu & alisa d. gean, second-impact syndrome and a small subdural hematoma: an uncommon catastrophic result of repetitive head injury with a characteristic imaging appearance, 27 j. neurotrauma 1557, 1557 (2010). 54. id. 55. id. 56. robert c. cantu, posttraumatic retrograde and anterograde amnesia: pathophysiology and implications in grading and safe return to play, 36 j. athletic training 244, 246 (2001). 57. 5 risks of repetitive concussions, neurotracker (aug. 22, 2017), https://neurotracker. net/2017/08/22/5-risks-repetitive-head-impacts/ [https://perma.cc/7p2y-x6aq]. 58. id. 59. zeigler, supra note 50. 60. chronic traumatic encephalopathy (cte), alzheimer’s assoc., https://www.alz. org/alzheimers-dementia/what-is-dementia/related_conditions/chronic-traumatic-encephalopathy(cte) [https://perma.cc/ckm8-jvau] 61. id. 62. id. 63. id. 320 indiana health law review [vol. 17:313 makes it more likely for a patient to end up with the condition.64 even if doctors and neurologists were able to diagnose someone with cte, there is no set treatment for someone who may have the condition, and the best course of action for someone who may be suffering from it is to avoid continued head trauma.65 this really puts players and athletes at even more of a risk: if there is no way to diagnose whether or not someone is suffering from cte, how is it reasonably safe to let them even continue to play such a dangerous sport? if league safety officials were to completely bar players from playing after they experience single or multiple concussions, they would be taking the necessary preventative steps towards making the game safer. but on the other hand, in the search for absolute safety, disallowing people from having a career, being employed, or simply enjoying high school or youth athletics because of their head trauma risks may be overstepping the boundaries. the truth is that with games as violent as football, there is no way to remove all danger, just as there is no way to make living a normal life absolutely safe.66 concussion occurrence in athletics is not a rare event, and that is expected.67 it is said that in competitive sports, it is estimated that close to 3.8 million concussions occur in the us alone.68 and even worse, close to 50% of these concussions may actually go unreported.69 in 2017 alone, it is estimated that 2.5 million high school students reported having experienced a concussion during their season, and of those 2.5 million, “an estimated 1 million reported experiencing two or more concussions during that time frame.”70 iii. part ii: historical view of the nfl and brain safety it is well known that concussions are a common injury sustained in the nfl because of the mere nature of the game.71 one columnist noted, “[h]eads and bodies get smashed and shuddered every week during football season. and despite changing the rules to allow for more severe penalties and fines for flagrant helmet-to-helmet hits, the nfl has not succeeded so far in preventing 64. id. 65. id. 66. see nicole wetsman, we have no idea how dangerous football really is, popular sci. (feb. 2, 2018), https://www.popsci.com/how-dangerous-is-football-cte#page-2 [https://perma. cc/xa7h-tk5m]. 67. ryan basen, can science solve football's concussion crisis?, nbc news (oct. 27, 2017), https://www.nbcnews.com/mach/science/can-science-solve-football-s-concussion-crisisncna809771 [https://perma.cc/2jxk-v26m]. 68. concussion and sports, brainline (jul. 30, 2018), https://www.brainline.org/ article/concussion-and-sports [https://perma.cc/vv95-7ac2]. 69. id. 70. lara depadila et al., self-reported concussions from playing a sport or being physically active among high school students—united states, 2017, 67 morbidity and mortality wkly rep. 682, 683 (2018). 71. wetsman, supra note 67. 2020] stop playing through it 321 concussions.”72 even with the nature of the game being so violent, league officials have not always taken a stance towards player safety.73 although the basic understanding of concussions has been around for many years, there really was no science and understanding of the dangers that are a result of blunt traumas to the head, and until 1994, the nfl took no stance towards concussions.74 during that year, then nfl commissioner, paul tagliabue, created the mild traumatic brain injury committee.75 however, tagliabue appointed dr. elliot pellman to be the chairman of the committee, despite having no previous experience with brain injuries.76 in 2002, forensic pathologist and co-founder of the brain injury research institute, dr. bennet omalu, performed an autopsy of the brain of deceased pittsburgh steeler center, mike webster.77 after studying webster’s brain, omalu suggested that webster had cte, and his suicide may have been a result of his constant head injuries that he sustained during the course of his career in the nfl.78 despite omalu’s findings, in 2005 the mild traumatic brain injury committee disregarded them, as they concluded that sustaining a concussion, “does not involve significant risk of second injury either in the same game or during the season.”79 after a year of finding more players with cte post-mortem, dr. pellman resigned as chair of the mtbic and the nfl finally decided to take action, and for the rest of 2007, the nfl decided to formalize new concussion guidelines and rules that would report when players were being forced to play through injuries . . . specifically head injuries.80 after being renamed to the head, neck, and spine committee, nfl commissioner roger goodell issued a memo to all nfl teams, preparing to increase preventative efforts of concussions and player’s safety by establishing that anyone in violation of the rules would be suspended, specifically stating that, “playing rules that unreasonably put the safety of another player in jeopardy have no place in the game, this being especially true in the case of hits to the head and neck.”81 from 2010 to 2013, three more retired players committed suicide and all were diagnosed with cte.82 in response to a 2013 lawsuit where the nfl and 72. brian resnick, what a lifetime of playing football can do to the human brain, vox (feb. 3, 2019), https://www.vox.com/science-and-health/2018/2/2/16956440/concussionsymptoms-cte-football-nfl-brain-damage-youth [https://perma.cc/9zy9-k7xb]. 73. kevin clark, a brief history of nfl rule changes allegedly ruining football, ringer (mar. 29, 2018), https://www.theringer.com/nfl/2018/3/29/17174936/targeting-rule-change-historyruining-football-roger-goodell [https://perma.cc/5922-5ve4]. 74. nfl concussions fast facts, cnn (aug. 15 2019), https://www.cnn.com/2013/ 08/30/us/nfl-concussions-fast-facts/index.html [https://perma.cc/52gv-762e]. 75. id. 76. id. 77. id. 78. id. 79. id. 80. id. 81. id. 82. id. 322 indiana health law review [vol. 17:313 4,500 ex-players reached a deal of $765 million to help “fund medical exams, concussion-related compensation, and medical research for retired nfl players and their families,” the nfl decided to donate more of its money and efforts to support research on concussions and cte to better understand why so many players were struggling with the condition.83 it wasn’t until 2016, that the nfl finally acknowledged that there was indeed a connection between football, concussions, and cte, and also during this year commissioner goodell announced his official plans to increase the safety of the game, with specific focus on preventing, diagnosing, and treating head injuries.84 so what did the nfl do in 2016? iv. the nfl’s new concussion protocol and rule changes the newly established concussion protocol took full effect in 2017 season and was the nfl’s best effort at preventing players from playing through head injuries after one had been sustained.85 the format is quite complicated, however. per espn, the protocol starts with staffing enough people to watch for concussions.86 more specifically, during each game, there are four independent medical professionals who observe from the sidelines.87 on top of this, there are also two certified trainers (atc’s) that are positioned above the field in a press box or suite acting as spotters.88 these spotters are equipped with “video playback gear and a dedicated radio connection with the sidelines.”89 furthermore, each team is assigned an “unaffiliated neurological consultant”, who works on the sidelines with the respective team doctor.90 this unc also has access to video replays to see if there are any players involved in plays likely to cause a concussion.91 while players are encouraged to “self-report” their conditions and/or symptoms, the doctor affiliated with the team is ultimately responsible for administering care to the possibly concussed player.92 also, the atc spotters, who undergo extensive training on how to spot someone who may be concussed, look for any players who they believe may be concussed, and have the authority to stop play for a medical timeout if they identify a player who they believe may be possibly concussed.93 if a player has shown signs of a concussion, he is taken 83. id. 84. id. 85. clark, supra note 73. 86. kevin seifert, how is the nfl concussion protocol supposed to work? espn (dec. 11, 2017), http://www.espn.com/blog/nflnation/post/_/id/261317/how-is-the-nfl-concussion-protocolsupposed-to-work [https://perma.cc/r4zd-grdh]. 87. id. 88. id. 89. id. 90. id. 91. id. 92. id. 93. id. 2020] stop playing through it 323 to what is called the “tent” to undergo what the nfl describes as a “sideline survey.”94 during this “sideline survey” the players are asked about the hit, and if the player is unable to recall, he is diagnosed with a concussion.95 another form of questioning that the trainers use is the “maddock’s questions” which require the player to perform random recall games such as reciting random events, stating the current month, or even solving a simple word problem.96 after either of these tests are complete, the doctor conducts a neurological exam to make sure everything is functioning properly in the player’s nervous system.97 this evaluation by the doctor includes a “cervical spine examination,” as well as a test for eye movement and speech clarity.98 if a player shows signs that he is concussed, then the player must be removed from the game and taken off the field to the locker room to go through even further assessments to test for the severity of the concussion.99 for this portion of the protocol, the team uses “scat 5” which is a concussion assessment tool that is a more comprehensive version of the sideline tests.100 if they pass the scat 5 test, they are cleared to return to the game, however, if they do not pass the scat 5 test, they are ruled out for the remainder of the game.101 if a player is ruled out, a player has a five-step process they must go through before they can be medically cleared to play or practice.102 this process includes making sure the player goes through each of these phases: rest and recovery, light aerobic exercise, continued aerobic exercise/strength training, football specific activities, and full football activity/clearance.103 if a team misses a concussion or lets a player play through a concussion knowing he is injured, the team is assessed a fine of up to $150,000 and forced to go through remedial education.104 one major issue to point out is that regardless of the capability to watch for concussions, a lot of concussed players go unwatched, and unfortunately some players who experience concussions do not take the necessary steps to get treated.105 much of this deals with the fact that concussions that are unseen by the spotters, referees, or medical staff fall unreported.106 94. id. 95. id. 96. id. 97. id. 98. id. 99. id. 100. id. 101. see id. 102. id. 103. id. 104. id. 105. bob grotz, despite concussion concerns, nfl players say game here to stay, del. county daily times (aug. 22, 2017), https://www.delcotimes.com/sports/despite-concussionconcerns-nfl-players-say-game-here-to-stay/article_285e4b14-5172-52b1-9ffb-939bf5fc19e6.html [https://perma.cc/765x-q9qf]. 106. seifert, supra note 87. 324 indiana health law review [vol. 17:313 in addition to implementing a new concussion protocol system, the nfl has also implemented new rules that attempt to prevent head unnecessary trauma.107 many of the head trauma rule changes started in the early 2000’s with one of the first making it illegal for defensive players to hit a quarterback “helmet-tohelmet” after a change of possession, such as an interception or a fumble recovery.108 this rule change was one of the first to put quarterback’s safety as a priority.109 in 2005, the nfl modified the “unnecessary roughness” rule, defined as “[u]nnecessarily running, diving into, or throwing the body against a player who should not have reasonably anticipated such contact by an opponent ” to apply to all players, not just ones out of bounds.110 in 2009, the nfl established that “[t]eams are not permitted to intentionally form a wedge of more than two players on a kickoff return in an attempt to block for the runner” as well as implement the defenseless receiver rule which states, “[i]t is an illegal hit on a defenseless receiver if the initial force of the contact by the defender’s helmet, forearm, or shoulder is to the head or neck area of the receiver.”111 both of these rules were once again attempts of the nfl to minimize the amount of unnecessary contact that a player receives during a game.112 in 2011, the nfl implemented the idea of moving back kick off locations, from the 30-yard line to the 35-yard line, to prevent full on collisions that occur during the most dangerous play of the game, kick offs.113 in 2012, the nfl “[expanded] the list [] to include defensive players on crackback blocks, making it illegal to hit them in the head or neck area.”114 while there were no drastic rule changes from 2013 to 2016, the nfl modified, expanded, and strengthened the “defenseless player” rule to include receivers running pass-routes in 2017.115 all of these rule changes were the nfl’s attempt to make the game safer, but their biggest changes came before the beginning of the 2018 season.116 efforts to positively change the rules regarding head safety were completely revamped at the start of the 2018 season.117 according to the nfl operations 107. leigh steinberg, helmet rule change: nfl's next step toward player safety, forbes (aug. 4, 2018), https://www.forbes.com/sites/leighsteinberg/2018/08/14/rule-change-nfls-next-stepat-player-safety/#625801607f7f [https://perma.cc/3peb-qwzc]. 108. health & safety rules changes, nfl, https://operations.nfl.com/football-ops/nfl-opshonoring-the-game/health-safety-rules-changes/ [https://perma.cc/7g8s-n2nx]. 109. id. 110. id. 111. id. 112. see id. 113. id. 114. id. 115. id. 116. see kevin seifert, guide to nfl's new rules: what to know about approved, tabled and rejected proposals, espn (mar. 28, 2018), http://www.espn.com/blog/nflnation/post/_/id/272769/ guide-to-nfls-new-rules-what-to-know-about-approved-tabled-and-rejected-proposals [https://perma.cc/4pga-nn66]. 117. id. 2020] stop playing through it 325 website, the biggest change came with the implementation of the “use of helmets rule.”118 this rule states, “[i]t is a foul if a player lowers his head to initiate and make contact with his helmet against an opponent. this rule pertains to all players on the field, and to all areas of the field.”119 regarding this rule the officials are to look for certain factors to determine whether or not a player should be penalized including, “[l]owering the head (not to include bracing for contact)[,] initiating contact with the helmet to any part of an opponent. contact does not have to be made in head and neck area – lowering the head and initiating contact to an opponent’s torso, hips and lower body is also considered a foul; [, and] making contact on an opponent (both offense and defense).”120 to further stress the importance of avoiding head injuries, the nfl implemented ejections for players who use the crown of the helmet as a way of tackling.121 when a player has been flagged for lowering his helmet to create contact, a team of officials in new york reviews the footage to dictate whether or not the player should be ejected from continued play.122 the new york team will notify the game officials that an ejection should occur if, “[t]he player lowers his helmet to establish a linear body posture prior to initiating and making contact with the helmet; [t]he player delivering the blow had an unobstructed path to his opponent; [and] if the contact was clearly avoidable.”123 v. is the nfl’s concussion protocol the golden standard? from the years 2012 to 2017, the nfl reported nearly 1,500 concussions, most of which occurred during a game, or in practice.124 even more disturbing, “[t]his data doesn’t cover the countless additional blows to the head that don’t reach the level of concussion but still may pose a risk for the brain.”125 even after the rule changes, the nfl is still seeing a drastic increase of the number of concussions per year.126 so, what is the problem? is it the fact that the game is too dangerous even with the newly implemented guidelines? is it the fact that players are too stubborn to self-report their symptoms? or, is it an unknown factor that hasn’t been considered yet? josh cribbs, a wide receiver who played eleven years for multiple teams in the nfl and sustained many concussions, stated in regards to the nfl’s efforts 118. see 2019 rules changes and points of emphasis, nfl, https://operations.nfl.com/therules/2019-rules-changes-and-points-of-emphasis/ [https://perma.cc/4kfc-fkzr]. 119. id. 120. id. 121. see id. 122. id. 123. id. 124. see resnick, supra note 73. 125. id. 126. kevin seifert, nfl concussions continue to rise, espn (jan. 26, 2018), https://www. espn.com/nfl/story/_/id/22226487/nfl-concussions-rise-highest-level-league-began-sharing-data [https://perma.cc/9gdd-9x7t]. 326 indiana health law review [vol. 17:313 to make the game safer that, “football is 100 percent injury.”127 during his “head safety and football panel discussion” with the association of health care journalist (ahcj), cribbs touched on the internal struggle to balance his love for the game with the notion that the game he actually loves could be hindering his ability to live a healthy life in the future.128 cribbs noted that the nfl contract system is incentive based, which unfortunately gives players the sub-conscious desire to play in as many games as possible regardless of their physical health status from a week to week basis.129 this ultimately forces some players to disregard their own future by covering up symptoms of concussions in hopes of being able to play the game they love and keep getting paid while doing so.130 this can be seen in the divide amongst players who are upset with nfl rule changes that have been implemented to make the game safer.131 eric weddle, safety of the baltimore ravens, was one of many players concerned with the nfl’s new rules and how it is negatively changing the sport.132 in an interview conducted after weddle was forced to watch the nfl’s video instructions on how to properly tackle during the 2018 season, weddle stated: i think the nfl is trying. . . you don’t want to fault them for putting in the effort to finding the best helmets and keeping players safe and all that. but the biggest problem i have is this: how do you not consult with the players and have them agree with it? you make these changes. well, we play the game. how are you going to make these cultural changes without asking us? they think that it is going to make the game better and safer. it’s not.133 while many of the players understand why the new rules were implemented—to ultimately make football as safe as possible—for the most part, players were in agreement that the rules were a bit drastic, harsh, and over the top.134 kevin seifert, a writer for nfl nation covering the rule changes, interviewed many veterans and noted that the players, “were not unappreciative of the league’s efforts.”135 however, he noted that, “the players simply questioned whether the initiative [would] work and who would be blamed if it doesn’t . . .[and that] a few 127. parimal rohit, concussions in the nfl: a player tells his story, ctr. health journalism (apr. 15, 2016), https://www.centerforhealthjournalism.org/2016/04/14/concussionsnfl-player-tells-his-story-part-1 [https://perma.cc/d6u9-nepn]. 128. see id. 129. id. 130. id. 131. kevin seifert, the nfl's latest safety measures face resistance from players, espn (aug. 9, 2018), http://www.espn.com/nfl/story/_/id/24318483/how-nfl-latest-safety-measures-faceresistance-players-helmet-rule-concussions [https://perma.cc/rs5b-6h2u]. 132. id. 133. id. 134. see id. 135. id. https://www.centerforhealthjournalism.org/2016/04/14/concussions-nfl-player-tells https://www.centerforhealthjournalism.org/2016/04/14/concussions-nfl-player-tells 2020] stop playing through it 327 [players] would prefer to make their own decisions about brain health.”136 many players like d.j swearinger, key safety for the washington redskins, issued concern over the rule changes because the nfl’s new tackling standards and rule changes may make gameplay more dangerous to other areas of the body.137 he stated in an interview: a lot of [players] would rather take their hit up top because they can live to see another day rather than have a knee injury . . . if i was an offensive player i would want to get hit right in my face because i signed up for football. i didn’t sign up for basketball. i didn’t sign up for soccer. i signed up for football.138 lastly, redskins running back chris thompson voiced his opinion on the rule changes by saying, “[y]ou’re trying to make the game safer. but football is a violent sport, and you are not going to be able to take that away from it.”139 rich mckay, nfl competition committee for the nfl stated in response, “[t]here’s no question it’s hard on [the players]. but they need to adjust. we’re not doing this to do anything other than make the game safer.”140 one truth resonates from both of the previous quotes, and that is the game is dangerously violent, and that factor will only increase over time as more skilled athletes with bigger physiques sign up to play every sunday, but the nfl has drastically tried to put forth maximum effort to change the game to make it safer for the players. there is a possibility that the sport itself has become too dangerous and that even attempts to reform the concussion protocol testing to make players safe is not enough because of the reliance of self-reporting.141 recalling a specific memory about his nfl career and the ways players avoided the protocol, josh cribbs told a story about one of the concussions he encountered while playing for the cleveland browns.142 after he was knocked down and completely dazed by a defensive tackle, cribbs knew that the hit that had occurred would require the appropriate medical personnel to assess whether or not he had been injured.143 after returning to the sidelines, the medical staff asked him what team the browns were playing against, to which if cribbs stated the wrong team or gave no answer at all would result in further tests and assessments to the extent of his concussion.144 cribbs noted had no idea who he was playing against and instead of responding an incorrect choice or giving no answer, he decided to buy time by acting as if he was out of breath until he could figure out what team the browns 136. id. 137. id. 138. id. 139. id. 140. id. 141. see resnick, supra note 73. 142. rohit, supra note 128. 143. id. 144. id. 328 indiana health law review [vol. 17:313 were playing against that sunday.145 even after faking being out of breath, he still did not know what team the browns were playing against, so he asked to be seated on the bench to buy even more time.146 while on the bench, he was again asked whom the browns were playing against, and he still had no idea, so in another attempt to stall, he heard the referee blow a whistle and he stood up and acted as if something major had happened on the field to distract the trainer.147 in the meantime, he glanced at the scoreboard and was able to figure out that the browns were playing the denver broncos and he was able to get medical clearance from the trainers.148 cribbs’s story goes to show the underlying motivation to continue to play through pain as a player, and the ultimate motivation to avoid being diagnosed with any injury, specifically a concussion in this instance, that would keep one sidelined. players will do whatever it takes to keep playing, regardless of the effects it has on their health, and they will continue to do so as long as the game exists. one thing is a certain, the nfl will continue to exist. it is stockpiled with fans that on a weekly basis pay top-dollar to go and see the exact aspects of the game that make it so dangerous big hits, physical violence, and humans at peak performance playing the sport they love. but, at the mere chance that there could be a better system, where should the nfl start looking if they choose to reform their current protocol? maybe they should look towards another dangerous sport. dana white of the ufc, (a competitive fighting league that is considered by most more brutal than football because it is basically boxing with little to no protection,) stated that the ufc’s concussion protocol is the best out there and that it is even better than the nfl’s.149 injuries in the ufc are normally gruesome, as there is no protective gear. without protective gear, it is highly probable that the fighters who undergo extensive bare-knuckled beatings to the head are susceptible to concussions.150 in his discussion, white described the ufc’s stance on concussions as being “a little more cautious” stating that, the ufc goes “‘above and beyond’ when it pertains to a fighter’s safety.”151 in full, dana stated: concussion[s] [are] a huge dilemma right now for the nfl. here's the difference between the ufc and the nfl as far as concussions are concerned. first of all, if you get a concussion, if you get knocked out or you get hurt whatsoever in the ufc, three months suspension. you are on suspension for three months and you cannot come back until you are 145. id. 146. id. 147. id. 148. id. 149. adam guillen jr., dana white on concussions: ufc is safer than the nfl, sb nation (jan. 8, 2013), https://www.mmamania.com/2013/1/8/3852326/ufc-president-dana-white-mmaconcussions-nfl-mma [https://perma.cc/h9ap-5z77]. 150. see id. 151. id. 2020] stop playing through it 329 cleared by a doctor. you can't have any contact whatsoever. in the nfl, you're not going to lose tom brady for three months, man. you lose tom brady for three months and your whole season is wiped out. so, the ufc, listen, we don't hide from it, it's a contact sport and that's [why] what these guys do, [is] much safer. in the 20-year history of the ufc, it will be 20-years in november, there has never been a death or a serious injury. never been a death or serious injury in 20 years because we go above and beyond when it comes to the safety of these guys. when you know you have two healthy athletes getting ready to compete, they get the proper medical attention before and after, it's the safest sport in the world, fact.152 so, in comparison to the nfl, the ufc uses a strict ninety-day suspension from any activity related to fighting. during this suspension, the fighters are not allowed to even revisit the doctor until the ninety days has been passed up, and this is a drastic difference when compared to the nfl policy. the nfl’s protocol has no minimum required sit out period.153 the distinction between the two sports is obvious—one is a team sport with a season lasting only four to five months at most—while being a fighter in the ufc is purely an individual sport where fights are scheduled on a four to five month basis. so, if the nfl adopted a minimum sit out requirement, they would lose key players for an extended amount of time, possibly losing them for a significant portion of the season. but, if the current protocol is not effective, as it has shown not to be, and the nfl wants to reduce and hopefully abolish the amount of current and retired players being diagnosed with cte after their death, shouldn’t they take the proper steps to promote absolute safety, even if this means benching one of their best players for ninety days? even more importantly, if an organization like the nfl reformed their standards as to how head trauma and head safety should be followed by their football players, shouldn’t indiana as a state reassess its stance and leniency towards high school player head safety? vi. part iii: concussions and indiana high school sports unlike the league officials and committee members of the nfl and other head trauma regulatory committees that have recently been committed to regulating rules and laws to make sports safer, the leaders of indiana haven’t always been on the fast track to making indiana sports safer in response to the raised awareness of the head trauma that can occur to those who participate in contact sports. however, the leaders and lawmakers of indiana changed their stance on may 10, 2011, when mitch daniels, a strong advocate for youth sports safety, made indiana the sixteenth state to recognize head trauma by signing a law 152. id. 153. nfl return-to-participation protocol, nfl player health & safety (jun. 20, 2017), https://www.playsmartplaysafe.com/focus-on-safety/protecting-players/nfl-return-to-participationprotocol/ [https://perma.cc/97rv-f9r8]. 330 indiana health law review [vol. 17:313 that was initially enacted in washington.154 the law that mitch daniels enacted is commonly known as the “zackery lystedt law” or the “lystedt law.”155 this law was created in may of 2009, and was the first state law specifically created with the idea of raising awareness of youth concussions.156 the law created four requirements for the states to follow: (1) the development of uniform concussion guidelines and distribution of educating materials regarding brain injury; (2) mandatory consent from parents for the participation in youth athletics; (3) immediate removal of the youth athlete from competition after suffering an apparent brain injury; and (4) mandatory compliance with return-to-play protocol before allowing the youth athlete to return to athletic competition.157 under this indiana law, there are certain guidelines in place that require the “development and dissemination of concussion guidelines, information sheets and forms to inform and educate coaches, student athletes and parents of the nature and risk of concussions, including the risk of continu[ed] play after concussion or head injury.”158 furthermore, with this law there is a requirement that, “youth athletes and a parent and/or guardian sign and return a concussion and head injury information sheet on a yearly basis before the athlete’s first practice or being allowed to compete.”159 regarding indiana’s specific protocol for concussions, under indiana code § 20-34-7-4, a student athlete who is suspected of sustaining a concussion or head injury in a practice or game, “[s]hall be removed from play at the time of the injury, and [] [m]ay not return to play until the student athlete has received a written clearance.”160 lindsey straus went on to explain the procedure in more depth when she noted that, “[y]outh athletes who have been taken out of a game because of a suspected concussion are not allowed to return to play until after: waiting 24 hours; being evaluated by a health care provider with specific training in the evaluation and management of concussions; and receiving a written clearance to play from that health care provider.”161 from the nfl to even high school sports, the ability to allow a child, teen, or nfl player to return to play places a strong sense of liability on specific health care providers. what happens when a healthcare provider allows someone to return to play when they in fact are not healed from an injury like a concussion, which shows almost no markers for complete recovery? straus also noted this in her article on concussions regarding legal immunity, “[a] licensed health care provider who evaluates a student athlete for concussion and in good faith 154. lindsey barton straus, youth sports concussion safety laws: indiana, moms team, https://www.momsteam.com/health-safety/youth-sports-concussion-safety-laws-indiana [https://perma.cc/d4h8-tc7d] (last modified mar. 30, 2015). 155. id. 156. id. 157. id. 158. id. 159. id. 160. ind. ann. code § 20-34-7-4 (west 2020). 161. straus, supra note 154. 2020] stop playing through it 331 authorizes a student athlete to return to play is not liable for civil damages resulting from an act or omission in the rendering of an evaluation unless the acts or omissions constitute gross negligence or willful or wanton misconduct.”162 realistically, what is stopping a parent or a coach from going to a legal professional and persuading them to let their player, son or daughter play in a big game? do we, as citizens, know for certain that doctors and medical professionals follow the rules as strictly as they should when it comes to clearing players who have head injuries? that is a question that is almost impossible to answer. it would seem that in a perfect world, no player would be allowed to go back to play prior to his or her full medical clearance from his or her health care provider, but the problem is we don’t live in a perfect world. if there is no liability pressed upon medical professionals unless they act in “gross negligence or willful or wanton misconduct,” who is to say that these professionals may or may not be making decisions as fans that may supersede their decisions as professionals?163 the identification of concussions is not just left up to professionals, however. in july of 2017, and stated under indiana code § 20-34-7-6(b), “[p]rior to coaching football to individuals who are less than (20) years of age and are in grades 1 through 12, each head football coach and assistant football coach shall complete a certified coaching education course that: (1) is sport specific; and (2) contains player safety content, including content on” concussion awareness; equipment fitting, heat emergency preparedness; and proper technique.164 basically, what these laws are doing is establishing a check that places responsibility not only on the health professionals, but also shifts some of that burden to the coaches in indiana. these training “seminars” are establishing a basis that “all coaches[,] for every public school sport offered to students . . . must complete a course on how to spot symptoms, such as dizziness and temporary loss of consciousness, and the potential consequences of concussions.”165 but, once again, how realistic is it that a coach who is preoccupied with doing his job, will have the absolute ability to fulfill his duties as a coach, as well as, fulfill his new role as a makeshift medical professional? the indiana high school athletic association, the primary governing body when it comes to rules for concussions and regulations regarding indiana sports, has taken its own stance regarding the concussion epidemic. per the national federation sports rulebook as stated in the ihsaa suggested guidelines for management of a concussion and pursuant to indiana laws and regulations, “[a]ny athlete suspected of having a concussion should be evaluated by an appropriate health care professional that day. any athlete with a concussion should be medically cleared by an appropriate healthcare professional prior to resuming 162. id. 163. id. 164. ind. ann. code § 20-34-7-6(b) (west 2020). 165. indiana mandates concussion training for public coaches (apr. 3, 2016), http://www.chicagotribune.com/news/nationworld/midwest/ct-indiana-concussion-training20160403-story.html [https://perma.cc/jz6j-mplr]. 332 indiana health law review [vol. 17:313 participation in any practice or competition.”166 regarding their protocol for concussions, they state the following: a high school student athlete who may have sustained a concussion or a head injury in a high school practice or a high school contest in an ihsaa recognized sport should immediately have the existence of a concussion or a head injury confirmed by the school’s medical person, who (i) is an individual who has training in the evaluation and management of concussions and head injuries and who is either an indiana athletic trainer atc/l or an indiana medical doctor (md) or doctor of osteopathic medicine (do) holding an unlimited license to practice medicine in the state of indiana, and (ii) has been assigned to a contest to provide medical services or has been assigned to provide medical services to students at a school’s athletic practice. if it is confirmed by the school’s medical person that the student athlete has not sustained a concussion or a head injury, the student athlete may continue participation in the contest or practice.167 furthermore, it makes mention that anyone suspected of having sustained an injury in a high school practice or contest should: (1) be removed from practice or the contest at the time of the injury is sustained, (2) be evaluated immediately by the appropriate health professionals, and (3) follow a step-wise concussion protocol.168 the sad truth is that within this documentation, there is no step-wise protocol even listed. one way that some schools governed by the ihsaa have established a way to get a baseline for concussion testing is by implementing what is called impact testing.169 however, even this is not a requirement for every school. impact stands for immediate post-concussion assessment and cognitive testing and is a neurocognitive assessment administered online in a controlled environment.170 the impact test has been around for almost twenty years and is known as “the first, [and] most-widely used, and most scientifically validated computerized concussion evaluation system.”171 one popular aspect of the test is 166. ind. high sch. athletic ass’n, ihsaa suggested guidelines for management of concussion, https://www.ihsaa.org/portals/0/ihsaa/documents/quick%20resources/ihsaa% 20concussion%20guidelines.pdf [https://perma.cc/t2wz-l6wn]. 167. id. 168. id. 169. see new indiana state law affects concussion management, brownsburg high school (2012), https://www.brownsburgathletics.com/information/concussion_info/concussion story [https://perma.cc/52ad-yqh9]. 170. r. robert franks, impact test: how it’s used to determine concussion recovery, phila. inquirer (nov. 30, 2012), https://www.inquirer.com/philly/blogs/sportsdoc/ what-is-an-impact-test.html [https://perma.cc/m5xf-3xtt]. 171. impact frequently asked questions, athletico, https://www.athletico.com/services/ head-injury-and-concussion-management/concussion/a-step-ahead-baseline-testing/impactfrequently-asked-questions/ [https://perma.cc/3xuz-2732]. 2020] stop playing through it 333 its simplicity in the way it is administered.172 the only requirement that is necessary for administration is that the administrator is trained.173 in regard to what the test consists of, there is one basic preliminary section which is called the “impact baseline test,” which is used “to establish how one’s brain functions in normal, everyday circumstances,” users can then compare this test to later test to see if a player has incurred a concussion or any other head trauma.174 for the baseline test, the test takers are asked to submit basic information regarding their demographics.175 the baseline test then ask the test takers report about any previous concussion that they may have had in the past.176 also, during the preliminary portion, the tester is asked about the symptoms experienced during the concussion, including, how long the symptoms lasted, how their sleep was affected, and whether or not they took medication for their symptoms.177 lastly, for the baseline portion, the testers are required to rate the severity and duration of twenty-two concussion symptoms.178 the test then divulges into its main part, a neurocognitive test, which is partitioned into six modules.179 these modules are: (1) word memory; (2) design memory; (3) a visual test which assesses reaction time and recall called “x’s and o’s”; (4) symbol matching; (5) color matching; and (6) a three-letter memory task.180 after the tester finishes, there is a score that is kept as his or her baseline.181 if a player experiences a concussion, he or she is then required to come in and take the impact test again to see if their new score deviates from their baseline score.182 the tester then retakes every portion of the test, from the preliminary portion to the module portion, and then receives his or her updated score.183 the last part of the “re-test” asks the tester to give a more detailed description of the event that may have caused the concussion, including safety equipment used, sport played, area of head hit, and upon completion the test is over.184 the trained software professional then takes the baseline score and compares it to the new score to see whether or not the player does in fact have a 172. see id. 173. id. 174. eunyoung song, immediate post-concussion assessment and cognitive testing (impact), scipol, https://scipol.duke.edu/track/immediate-post-concussion-assessment-andcognitive-testing-impact [https://perma.cc/ld9c-shnk]. 175. franks, supra note 170. 176. id. 177. see id. 178. id. 179. id. 180. see impact, impact 2007 (6.0) clinical interpretation manual 37-42 (2007), https://www.sjschools.org/images/athletics_hs/impact_clinical_interpretation_manual.pdf [https://perma.cc/7x3f-e4mj] 181. song, supra note 174. 182. id. 183. id. 184. see franks, supra note 170. 334 indiana health law review [vol. 17:313 concussion.185 overall, the test is not lengthy as it normally only takes around twenty-five minutes.186 according to dr. dan kraft, co-director of the indiana sports concussion network, “approximately two-thirds of the schools in indiana are currently using impact.”187 this raises the question as to why it isn’t mandatory for every school in the state to use the impact test to help detect concussions better. is it due to finances or is it the fact that the remaining onethird of schools is under the belief that maybe player safety isn’t of absolute importance? while impact testing is useful, there is the risk that there may be some ways that someone could actually manipulate the scores. while i conducted an interview of a football player at a local high school in indiana, this player revealed to me that his school used the impact test, and that some of his teammates came up with the idea to score as low as possible on the baseline test so that at the random possibility of getting a concussion, they would be able to at least have a fair shot at beating the baseline scores.188 in fact, the player noted that this was also encouraged by some of his teammates’ parents, once again bringing to light the idea that players are sometimes wrongly instilled with the unfair ideology of playing through pain.189 but, enough is enough. it is time that indiana takes a stand for player “head” safety and become a leader in the field in the fight towards making high school sports as safe as possible.190 there are many problems that need to be addressed that have been mentioned above and here are some simple solutions that the state of indiana can use to establish a safer playing environment for our high school athletes. vii. what can indiana do? if indiana wants to be a leader in promoting player safety, specifically regarding the prevention of head trauma, we need to look to the nfl’s standard for concussion protocol and see if we can implement their approach and, in some way, make it even better. in efforts to get more personal opinions about head trauma in indiana, i conducted an interview with a parent of an indiana high school football player who attends a well-known football school in the state.191 regarding player safety, the parent was keen on the idea of creating a safer game in indiana, and instantly made recollections about attending a recent game where he specifically wanted to watch how the trainers and medical personnel were 185. song, supra note 174. 186. what is impact testing and why is it important to you? top tier sports med., http://www.toptiersportsmed.com/what-is-impact-testing-and-why-is-it-important-to-you/ [https://perma.cc/x32d-esdt] 187. nat newell, the hardest hit, indianapolis star, oct. 1, 2010, § local metro & state, at a1. 188. interview with a senior from warren central high school who wishes to remain anonymous (aug 28, 2018). 189. id. 190. id. 191. interview with a vernon williams (aug. 28, 2018). 2020] stop playing through it 335 handling head safety.192 at this game the interviewee noted that there was one trainer, one team doctor that was present for both teams, and two assistant trainers that were students.193 during the game, the parent noted that a player got hit in the head and, of course it was violent, but it was not violent enough for the player to get taken off of the field by assistants or anyone else, as most concussions are not.194 this player actually removed himself from the game and went and sat on the bench.195 from the time of the injury until the fourth quarter of the football game, the only person who came and talked to him was the head coach. not once did the trainer, the team doctor, nor the assistants come to even check up on him.196 this raises a big question – are indiana high school athletic programs properly equipped to help make the game safer? if there is only one trainer – who is tasked with evaluating other players, making sure the training facilities are in proper service, as well as watching the game – and who is ultimately tasked with keeping an eye out for player safety, how can we possibly say with full conviction that we are making the game as safe as possible in indiana? as noted above, the nfl staffs a full team to specifically watch for head trauma and they still suffer the consequences of seeing players get hurt week in and week out. shouldn’t we be focusing our efforts on maintaining players safety at the age where the brain is most vulnerable? maybe we should be looking into other means of safety precautions such as helmet regulation. some people believe that there should be rules established that mandate football players to wear certain helmets.197 gene cato, the commissioner of the ihsaa stated, “i think we all must be concerned about the safety and welfare of the players even though these things aren’t mandated.”198 he even went on to suggest that it would be ideal to not strictly mandate helmets, but make sure the safety of the helmets is up-kept.199 but this has never happened. most high school teams are sponsored by certain corporations that supply the equipment that players use.200 while there are some schools that allow players to use their own equipment, some schools make it mandatory that the players use school sponsored equipment, whether it is safer or not.201 in a study conducted by the virginia tech school of biomedical engineering 192. id. 193. id. 194. id. 195. id. 196. id. 197. roman modrowski, are football helmets safe? lack of rule ties ihsaa's, nwi.com (oct. 2, 1991), https://www.nwitimes.com/uncategorized/are-football-helmets-safe-lack-of-ruleties-ihsaa-s/article_1052a8a8-041c-5273-aef3-b43445cf19a6.html [https://perma.cc/ay2t-hb8u]. 198. id. 199. id. 200. see bob segall, investigation prompts schools to remove low-rated football helmets, wthr (apr. 14, 2016), https://www.wthr.com/article/investigation-prompts-schools-to-removelow-rated-football-helmets [https://perma.cc/ad7y-g4kz]. 201. see id. 336 indiana health law review [vol. 17:313 and sciences, researchers tested the different brands and models of helmets that football players use in each level of play to see which helmet is most efficient at preventing concussions and other brain trauma.202 the research team, which started it study on the effectiveness of helmets in the early 2000’s, ultimately came up with a rating system called the star (summation of tests for the analysis of risk) system which “grade[s] helmets according to their ability to reduce brain acceleration during different types of hits.”203 the results of the research raised awareness from league officials and schools alike by showing that a helmet with a five-star rating drastically reduced the amount of gravitational forces when compared to a helmet with a one-star rating.204 in relation to indiana, recently a team of investigators found out that many of indiana high schools use helmets that would receive a one-star rating.205 and, even more frightening is the fact that many of these schools are aware of the rating system and the dangers that can be present in using a low rated helmet.206 the problem lies with the cost of higher rated helmets, and the assumption that younger aged players aren’t exerting enough gravitational force to cause significant brain injury, but this would contradict any idea or notion that there is a common ground effort to protect our youth’s health when they participate in violent sports such as football.207 it is time to aside our misplaced pride and really dig deep to see what we value as a state. how much does safety cost, and how much does a life cost? should indiana value the idea of saving money over the value of keeping high school athletes safe? viii. resolution it is obvious that there is a problem. in indiana specifically, the state has lost sight of the value of safety regarding our high school athletes, especially in the sport that leaves players at a higher risk for head trauma than any other football. it is easy to point out the flaws, but it should be just as easy to recognize the problems and establish a plan to fix the problems. stefan duma, the key researcher for the virginia tech helmet safety stated that the importance of making football safer is not just through better equipment but also by reassessing the many culminating factors that can be changed to make the game safer.208 duma stated, “[t]here are three things that have to be done . . . the first and most important is [changing] league rules; the second is coaching technique; and the third layer is equipment.”209 and, duma is correct. in order to make football safer 202. richard lovegrove, hard -h itting research , va . te c h ma g . , https://www.vtmag.vt.edu/winter17/helmet-research.html [https://perma.cc/8q6y-98er]. 203. id. 204. id. 205. segall, supra note 200. 206. id. 207. id. 208. lovegrove, supra note 202. 209. id. 2020] stop playing through it 337 in indiana, there needs to be changes implemented to the ihsaa rules regarding the equipment being used. therefore, indiana lawmakers should drive these changes in the ihsaa rules through legislation. indiana needs to address player safety by supplying schools with more funding to athletic programs so that they are fully equipped with the appropriate staff during practices and games. it is obvious that the nfl is a money making machine, so it is much easier for them to supply teams with the appropriate staffing to watch specifically for head trauma; consequently, if the state realizes that head trauma is a major issue here as well, and we accept the truth that players in their teens are more susceptible to long term brain issues from concussions, all while accepting the fact that it is important to still allow teens to play the sports they love, then the choice to increase funding to high school athletic programs should be a simple one to make. furthermore, the ihsaa should work toward adapting the nfl’s concussion protocol with one major change. in order to make high school football safer in indiana, we need to implement the mandatory sit out policy that the ufc has established. if a player sustains a concussion, they should be required to sit out for at least two weeks. this creates a balance between the minimum ninety days that the ufc has established, and the almost non-existent time period that is established currently in the nfl and ihsaa. it would also be ideal for the ihsaa and legislatures to do extensive research to determine what helmet is safest to use and then implement that standard helmet statewide. furthermore, the ihsaa needs to do extensive research as to what the nfl has done regarding rule changes to make the game as safe as possible and implement these rules immediately to prevent unnecessary injury. lastly, there needs to be more training done in all facets of the game. referees, coaches, and trainers need to be better equipped with the knowledge and skills necessary to help accurately spot when a player has a concussion, and then take the necessary steps to remove them from practice and play. it is important to understand that high school players do not make money. many of them play merely because they love the sport. their passion to step on the field on a daily basis to work as a unified group towards winning a game is always present. the same passion for the game is true for nfl players and collegiate players; however, players at that level are getting scholarships to attend the school or are getting paid millions of dollars to participate. these high school athletes are sacrificing themselves merely because they love the sport and if we, as a state and law makers, truly cares about the safety of our high school athletes, we will do whatever it takes to change the rules, change the safety precautions, and change the way we view head trauma in sports. the syringe that drips money: how title vii affects employer-mandated vaccinations in the manufacturing sector conner j. voegel* i. introduction on december 31, 2019, as many around the world were celebrating the new year, chinese health officials were reporting to the world health organization (“who”) that approximately forty-one people had contracted a mysterious pneumonia from the huanan seafood wholesale market.1 within seven days, chinese officials determined the virus was a novel coronavirus, now known as sars-cov-2, which causes the covid-19 illness.2 the virus rapidly spread throughout the world, including the united states, and prompted all but eight states to issue statewide shutdown orders.3 these shutdowns, which had questionable effectiveness,4 closed businesses, hamstrung the supply chain, and are expected to play a role in shrinking the united states’ expected real gross domestic product (“gdp”) by $7.9 trillion over the next decade.5 however, sars-cov-2 is not the first pandemic to cause a mass disruption. for instance, the 1918 h1n1 pandemic swept across the globe, prompting quarantines, shutdowns, social distancing, and mask use throughout the united states.6 * j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.a., 2019, university of southern indiana. i would like to thank dr. robert brookins, professor of law at indiana university robert h. mckinney school of law; daniel orenstein, visiting assistant professor of law at indiana university robert h. mckinney school of law; and steven clark, member at stoll keenon ogden pllc for their assistance with this note. 1. sandip sen, how china locked down internally for covid-19, but pushed foreign travel, econ. times (apr. 30, 2020, 10:55 am), https://economictimes.indiatimes.com/blogs/ whathappensif/how-china-locked-down-internally-for-covid-19-but-pushed-foreign-travel/ [https://perma.cc/uz3v-sfm3]. 2. id. 3. jiachuan wu et al., stay-at-home orders across the country, nbc news, https://www. nbcnews.com/health/health-news/here-are-stay-home-orders-across-country-n1168736 [https://perma.cc/q7ln-uh37] (last updated apr. 29, 2020). 4. donald l. luskin, the failed experiment of covid lockdowns, wall st. j. (sept. 1, 2020, 6:54 pm), https://www.wsj.com/articles/the-failed-experiment-of-covid-lockdowns-1159900 0890 [https://perma.cc/azr4-mdvn]. but see marco vinceti et al., lockdown timing and efficacy in controlling covid-19 using mobile phone tracking, 25 eclinicalmedicine 1, 7 (2020) (finding the italian shutdown measures generally began to slow the spread of sars-cov-2 after 14-18 days). 5. letter from philip l. swagel, dir., cong. budget off., to hon. charles e. schumer, democratic leader, u.s. senate (june 1, 2020), https://www.cbo.gov/system/files /2020-06/56376gdp.pdf [https://perma.cc/xdz4-gwqq]. 6. richard j. hatchett et al., public health interventions and epidemic intensity during the 1918 influenza pandemic, 104 proc. nat’l acad. sci. u.s. am. 7582, 7583 (2007) (providing a 218 indiana health law review [vol. 19:217 while novel viruses such as sars-cov-2 and h1n1 have caused extreme economic hardships and widespread morbidity, communicable diseases have also been doing so for decades. nevertheless, many private employers outside the healthcare industry have never implemented mandatory vaccination policies.7 while there are multiple reasons employers may refuse to enact such policies,8 fearing legal action under title vii of the civil rights act of 1964 (“title vii”) is among the most prevalent. this note will analyze the legal ramifications title vii has on employer mandated vaccination policies, specifically focusing on the manufacturing sector. section ii provides relevant background information for vaccine mandates in the industry. section iii analyzes title vii, including the different claims employees have under the statute and certain affirmative defenses available to employers. section iv then applies reasonable accommodation and undue hardship to the manufacturing sector. section v provides certain factors manufacturers should consider when determining whether a vaccine mandate is the best option for their facility. finally, section vi concludes that, with guaranteed exceptions, title vii poses little legal threat to mandatory vaccination policies in the manufacturing sector. ii. background information to best understand vaccine mandates and why this note focuses on the manufacturing sector, this section provides details on the industry’s economic importance, a brief history of government-mandated vaccine policies, the impact of vaccine preventable diseases (“vpds”), and potential reasons people refuse vaccines. a. the importance of manufacturing as of june 2021, the united states manufacturing industry employs over summary of mitigation techniques during the 1918 pandemic in table 1); nina strochlic & riley d. champine, how some cities ‘flattened the curve’ during the 1918 flu pandemic, nat’l geographic (mar. 27, 2020), https://www.nationalgeographic.com/history/2020/03/ how-citiesflattened-curve-1918-spanish-flu-pandemic-coronavirus/ [https://perma.cc/e9e7-37lr]. 7. cf. tina bellon, u.s. employers could mandate a covid-19 vaccine, but are unlikely to do so-experts, reuters (dec. 2, 2020, 11:30 am), https://www.reuters.com/article/us-healthcoronavirus-vaccine-companies/u-s-employers-could-mandate-a-covid-19-vaccine-but-areunlikely-to-do-so-experts-iduskbn28c2ll [https://perma.cc/w9gg-6ua8] (stating vaccine mandates are common in the healthcare industry). the article states vaccine mandates are common only in the healthcare industry, so readers can infer such mandates are uncommon in other private industries. 8. 42 u.s.c. § 2000e-2. title vii is a federal statute that works to eliminate discrimination in the workplace. see id. while title vii is the focus of this note, comparisons to the americans with disabilities act (“ada”) and other considerations will be mentioned when appropriate. these other laws and considerations should be examined further in future research on employer-mandated vaccine policies. 2022] the syringe that drips money 219 twelve million people.9 manufacturing is particularly important because it provides high wages for industry employees. manufacturing industry wages range from an average of $23.12 per hour for production and nonsupervisory positions, to an average of $28.92 per hour for all positions.10 in contrast, the federal minimum wage is only $7.25 per hour.11 additionally, a 2019 study found u.s. manufacturing accounted for approximately $2.3 trillion in total output—11.39% of the united states’ gdp.12 moreover, manufacturing accounted for approximately $274 billion in total domestic research and development in 2018.13 b. state-sponsored vaccination mandates within the united states for over a century, the united states supreme court has held that, with few exceptions, states may use their police power to mandate vaccines in an effort to suppress and prevent the spread of communicable diseases.14 in jacobson v. massachusetts, the board of health for cambridge, massachusetts enacted a regulation requiring smallpox vaccinations for all inhabitants of the city.15 the jacobson holding still plays out every day in the vaccination requirements of both public and private educational institutions.16 while the jacobson holding was premised on the police power, the court also rationalized its decision with the idea of a “social compact” that can limit the 9. databases, tables & calculators by subject, u.s. bureau lab. stats., https://data.bls. gov/timeseries/ces3000000001 [https://perma.cc/2l36-skhb] (last visited july 20, 2021). 10. id. 11. but see state minimum wage laws, u.s. dep’t lab., https://www.dol.gov/ agencies/whd/minimum-wage/state [https://perma.cc/y8xh-whyg] (last visited feb. 28, 2021) (showing 29 states provided higher minimum wages than the federal minimum wage). the wages listed are still lower than the manufacturing industry average. see id. 12. 2019 united states manufacturing facts, nat’l ass’n mfrs, https://www.nam.org/statemanufacturing-data/2019-united-states-manufacturing-facts/ [https://perma.cc/nuq6-v8fe] (last visited jan. 25, 2021). 13. raymond m. wolfe, u.s. businesses reported $441 billion for r&d performance in the united states during 2018, a 10.2% increase from 2017, nat’l ctr. for sci. & eng’g stats. (aug. 26, 2020), https://ncses.nsf.gov/pubs/nsf20316/ [https://perma.cc/58ce-4m6q]. 14. jacobson v. massachusetts, 197 u.s. 11, 25-26 (1905); zucht v. king, 260 u.s. 174, 176 (1922) (upholding jacobson). the constitutionality of state-sanctioned mandatory vaccination cases will be determined on the “necessities of the case.” jacobson, 197 u.s. at 28. 15. cf. jacobson, 197 u.s. at 12 (holding there was an exception to the regulation for children who had a note from a physician stating they were unfit for vaccination). 16. jacobson, 197 u.s. at 25-26; zucht, 260 u.s. at 177 (upholding a state-mandated vaccine policy for a private school); see klaassen v. trs. of ind. univ., no.1:21-cv-238 drl, 2021 u.s. dist. lexis 133300 (n.d. ind. july 18, 2021), aff’d, no. 21-2326, 2021 u.s. app. lexis 22785 (7th cir. aug. 2, 2021), inj. denied, no. 21a15, 2021 u.s. lexis 3677 (aug. 12, 2021) (upholding indiana university’s covid-19 vaccine mandate); see also ind. code § 20-34-4-5 (2021) (requiring parents to provide the school a vaccination statement proving their child has been vaccinated for certain diseases). 220 indiana health law review [vol. 19:217 freedom of some for the common good of all.17 for example, the court stated: but the liberty secured by the constitution of the united states to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. there are manifold restraints to which every person is necessarily subject for the common good.18 continuing its discussion on liberty, the court noted that, “[e]ven liberty itself, the greatest of all rights, is not unrestricted license to act according to one’s own will. it is only freedom from restraint under conditions essential to the equal enjoyment of the same right by others.”19 thus, the court allows the intrusion into one’s liberty based on the safety and wellbeing of the general population. employers do not possess the police power, so they must look towards other authorities to mandate vaccines. for example, an employer may use its contractual authority. this authority is, however, limited by title vii and other laws. nevertheless, because employers must use other authorities to implement such mandates, this note will not apply the jacobson holding to its analysis. while jacobson provides important historical context to vaccine mandates, its authority would not be persuasive in a private sector employment case. c. vaccine preventable diseases and their impact vpds are viral and bacterial diseases that spread among humans, but can be slowed or prevented by vaccination.20 in 2021, the who listed twenty-five known vpds that can be treated by vaccines available to the public.21 a few common examples of vpds include influenza, tetanus, mumps, and polio.22 the who also considers sars-cov-2 a vpd.23 the who estimates vaccines prevent millions of deaths each year, and yet vpds continue to be the cause of death for approximately 1.5 million people annually due to inability or refusal to get vaccinated.24 while morbidity caused by vpds is striking, the diseases also have a significant impact on the economy. for example, one study has estimated 17. jacobson, 197 u.s. at 27. 18. id. at 26. 19. id. at 26-27 (quoting crowley v. christensen, 137 u.s. 86, 89 (1890)). 20. samantha vanderslott, how is the world doing in its fight against vaccine preventable diseases?, glob. change data lab (apr. 24, 2018), https://ourworldindata.org/ vaccinepreventable-diseases [https://perma.cc/5yk8-wwhs]. 21. immunization, vaccines and biologicals, world health org., https://www.who.int/ teams/immunization-vaccines-and-biologicals/diseases [https://perma.cc/fl9b-yxej] (last visited july 20, 2021). 22. id. 23. id. 24. vanderslott, supra note 20. 2022] the syringe that drips money 221 employees miss approximately 3.5 workdays upon onset of influenza symptoms.25 another study found seasonal influenza has a total economic burden of approximately $11.2 billion, 71.3% of which comes from “indirect costs” such as loss of productivity due to work absenteeism and death.26 additionally, sarscov-2 will have long-term effects on the u.s. economy, shrinking it by an estimated $7.9 trillion throughout the next decade.27 manufacturers, especially those of nonmedical and nondurable goods, were severely impacted due to a decline in consumer need throughout the sars-cov-2 pandemic.28 however, certain manufacturers had the opposite issue. for instance, soda and beer companies saw unprecedented demand for canned and bottled beverages, forcing them to slow or cease production of certain products due to shortages of aluminum.29 d. why people refuse vaccines people refuse vaccines for innumerable reasons; thus, this section only focuses on legally relevant explanations.30 religious beliefs are generally among the most prevalent reasons for refusal.31 other reasons include philosophical 25. jeffrey j. van wormer et al., influenza and workplace productivity loss in working adults, 59 j. occupational & env’t med. 1135, 1138 (2017). these missed days amounted to approximately $7 billion in lost wages. patricia curran, the economic effect of influenza on businesses, soc’y hum. res. mgmt. (dec. 13, 2012), https://www.shrm.org/ resourcesandtools/hrtopics/risk-management/pages/economic-effect-influenza-businesses.aspx [https://perma.cc/n46u67rd]. along with incurring sick-time costs for approximately two-thirds of the missed workdays, it is also estimated employers lose around $10 billion in productivity each year because of the flu. id. 26. wayan putri et al., economic burden of seasonal influenza in the united states, 36 vaccine 3960, 3964 (2018). the total economic burden ranges from $6.3-$25.3 billion. id. at 3965. 27. letter from philip l. swagel to hon. charles e. schumer, supra note 5. 28. coronavirus update: industry fast facts, ibisworld (june 1, 2020), https://www. ibisworld.com/industry-insider/coronavirus-insights/coronavirus-update-industry-fastfacts/#manufacturing [https://perma.cc/68wt-2c6l]. 29. nathan bomey, another shortage! beer, soda makers struggle with aluminum can supply, plan to limit niche drinks, usa today, https://www.usatoday.com/story/money/2020/07/ 15 /aluminum-can-shortage-beer-soda-coca-co la -pepsico-covid-19 /5443308002/ [https://perma.cc/em3s-wcrw] (last updated july 16, 2020). but cf. sanjoy kumar paul & priyabrata chowdhury, a production recovery plan in manufacturing supply chains for a highdemand item during covid-19, 51 int’l j. physical distrib. & logistics mgmt. 104 (providing analysis on how manufacturers can recover after unprecedented demand of certain products). 30. this section recognizes disability as an inability to obtain a vaccine as opposed to a refusal, and thus it is not considered for purposes of this note. 31. chephra mckee & kristin bohannon, exploring the reasons behind parental refusal of vaccines, 21 j. pediatric pharmacology & therapeutics 104, 106-07 (2016) (arguing religion goes to the core of a person, making it difficult to change that belief). 222 indiana health law review [vol. 19:217 and/or personal beliefs, including general anti-vaccination sentiments.32 some individuals are also concerned with the safety of vaccinations.33 finally, some refuse vaccines simply due to a want for more information.34 people refusing vaccinations for lack of information is important for many reasons, especially because employers may be able to persuade employees to get vaccinated by supplying medical advice through local healthcare providers. although it can be time-consuming and costly, persuasion tends to lead to better results over time when compared to coercive techniques such as vaccine mandates.35 based on how courts have defined religion,36 those within the antivaccination movement may be able to successfully argue to a court that their beliefs are religious in nature. to many, this proposition seems preposterous due to its link to personal, non-religious beliefs.37 theories of the anti-vaccination campaign have been overwhelmingly disproven by science.38 nevertheless, the anti-vaccination campaign, which is predominately the product of social media use,39 may become an issue for employers when applying a court’s definition of 32. id. at 107. 33. id. at 107-08. see julia ries, you’re more likely to be hit by lightning than to have severe vaccine allergy, healthline (apr. 8, 2019), https://www.healthline.com/healthnews/youre-probably-not-allergic-to-vaccines [https://perma.cc/n5za-ptyp] (citing derek k. chu & zainab abdurrahman, vaccine allergy, 191 can. med. ass’n j. e395 (2019)) (arguing safety concerns are generally misguided). some people, though very few, are known to have severe, adverse reactions to certain vaccines which could present ada issues. see 42 u.s.c. § 12112. 34. mckee & bohannon, supra note 31, at 108. 35. daniel g. orenstein & y. tony yang, from beginning to end: the importance of evidence-based policymaking in vaccination mandates, 43 j. l. med. & ethics 99, 99 (2015). it is presumed persuasion can only be more effective than coercion if the party receiving the information is open to logical, scientific reasoning. nevertheless, the proposition that persuasion can be more effective than coercion will be an important reminder for employers moving forward. see infra section v. 36. see infra text accompanying notes 45-50. 37. see mckee & bohannon, supra note 31, at 107 (providing arguments generally used by the anti-vaccine campaign). 38. cf. autism and vaccines, ctr. for disease control & prevention, https://www.cdc. gov/vaccinesafety/concerns/autism.html [https://perma.cc/s24g-pf74] (last visited mar. 19, 2021) (arguing vaccines do not cause autism); see generally julie a. boom et al., vaccine myths: setting the record straight, 18 j. fam. strengths 1 (2018). 39. elvira ortiz-snchez et. al., analysis of the anti-vaccine movement in social networks: a systematic review, 17 int’l j. env’t rsch. & pub. health 5394 (2020), at 10. but cf. lauren dunn & linda carroll, some doctors helping anti-vaccine parents get medical exemptions, nbc news (jan. 27, 2019, 4:01 pm), https://www.nbcnews.com/health/kids-health/some-doctorshelping-anti-vaccine-parents-get-medical-exemptions-n963011 [https://perma.cc/e3as-erll] (providing some u.s. doctors are unethically advancing this campaign); barbara maria kollataj et al., anti-vaccine movements – health care, ignorance or a diversion aimed at destabilizing the health situation? part 2. contemporary conditions for the functioning and development of antivaccination movements, 27 annals agric. & env’t med. 553, 555-56 (2020) (providing polish 2022] the syringe that drips money 223 religion.40 iii. title vii title vii is a federal statute that applies to employers with at least fifteen employees for at least twenty calendar weeks in a year.41 courts have expressed congress’s objective in title vii is clear from the language of the statute—to remove barriers that have created unequal employment opportunities throughout history.42 title vii prohibits employers from discriminating against employees because of their race, color, sex, national origin, or religion.43 while a vaccine mandate could create a discrimination claim under any of the protected classes, a religious discrimination claim is the most conceivable challenge to such a mandate.44 thus, to best explain religious discrimination under title vii, this section will be broken into five subsections that define religion, analyze the sincerity needed for a religious belief, describe the potential legal claims afforded to employees, discuss the principle of reasonable accommodation, and explain undue hardship. a. defining religion defining religion is a consequential step in a title vii religious discrimination claim, and one that could provide arguments to those with sincerely held personal beliefs.45 title vii broadly defines religion as “all aspects of religious observance and practice, as well as belief.”46 the united states examples of doctors promoting the anti-vaccination movement). 40. but see fallon v. mercy catholic med. ctr., 877 f.3d 487 (3d cir. 2017) (finding antivaccine belief was medical rather than religious in nature); mason v. gen. brown cent. sch. dist., 851 f.2d 47, 51 (2d cir. 1988) (upholding that the anti-vaccine belief was not based “on religious grounds, but on scientific and secular theories”); brown v. children’s hosp. of phila., 794 fed. appx. 226 (3d cir. 2020) (finding anti-vaccine belief was not religious). 41. 42 u.s.c. § 2000e(b). this note presumes most manufacturers will meet the basic requirements of title vii and be subject to its provisions. 42. see griggs v. duke power co., 401 us. 424, 429-31 (1970) (explaining the overarching goal of title vii, but specifically applying title vii to a racial discrimination case). 43. 42 u.s.c. § 2000e-2(b). 44. cf. dylan j. yépez, healthcare employers: exercise caution when enforcing mandatory vaccination policies, nat’l l. rev. (july 5, 2019), https://www.natlawreview. com/article/ healthcare-employers-exercise-caution-when-enforcing-mandatory-vaccination-policies [https://perma.cc/lfd2-za9b]. 45. see generally joshua t.b. williams et al., religious vaccine exemptions in kindergartners: 2011-2018, 144 pediatrics 1, 3-4 (2019) (finding states with vaccine exemptions for religious and personal beliefs “had significantly lower mean proportions of kindergartners with religious exemptions [. . .] compared with states with religious exemptions only”). the researchers suggest those with personal beliefs are likely disguising such as religious beliefs when the state only provides a religious exemption for school children. id. 46. 42 u.s.c. § 2000e(j). 224 indiana health law review [vol. 19:217 supreme court has adopted this definition;47 however other courts have expanded the scope, allowing its reach to be virtually unlimited by including any conduct that is motivated by religion—meaning “all forms and aspects of religion, however eccentric.”48 in fact, the united states district court for the southern district of ohio recently observed that “religious practices [. . .] include moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of religious views.”49 with this broad definition of religion, the court allowed the plaintiff to prevail over a motion to dismiss because it was “plausible that [p]laintiff could subscribe to veganism with a sincerity equating that of traditional religious views.”50 some may brush off this opinion as extreme and unlikely to have weight in other jurisdictions, but it provides an example of how courts may define religion and subsequently force employers to seriously consider any belief, no matter how unique. b. sincerity of the religious belief the next step in a title vii analysis is determining whether the employee sincerely holds the claimed religious belief. as previously stated, religion includes both traditional religious beliefs and moral and ethical beliefs that are “sincerely held [with] the strength of [religion].”51 thus, the employee’s sincerity in their specific belief is determinative.52 sincerity is subjective, often making is difficult for employers to disprove the sincerity of an employee’s belief.53 in fact, 47. trans world airlines inc. v. hardison, 432 u.s. 63, 71-72 (1977). 48. redmond v. gaf corp., 574 f.2d 897, 900-01 (7th cir. 1978) (citing cooper v. general dynamics, 533 f.2d 163, 168 (5th cir. 1976)). while courts are willing to protect eccentric, religious behavior, this behavior is also, in part, defined by societal norms. for example, while generally not an issue within employment law, polygamy is outlawed in all 50 states—presumably because of societal norms—even though it has been and continues to be practiced by various denominations of the mormon church. e.g., ind. code § 35-46-1-2 (2021). while still illegal, utah has effectively decriminalized polygamy by changing its penalty to an infraction. see utah code ann. § 76-7-101 (west 2021). 49. chenzira v. cincinnati children’s hosp. med. ctr., no. 1:11-cv-00917, 2012 wl 6721098, at *4 (s.d. ohio dec. 27, 2012) (citing 29 c.f.r. § 1605.1 (2012)). defining religion as such is parallel to some states allowing philosophical or personal belief vaccine exemptions for students. e.g., colo. rev. stat. ann. § 25-4-903(2)(b)(i) (west 2020). 50. chenzira, 2012 wl 6721098, at *4. but see friedman v. s. cal. permanente med. grp., 125 cal. rptr. 2d 663, 685-86 (cal. ct. app. 2002) (holding veganism does not constitute a religious belief under california’s fair employment and housing act, which provides protections similar to title vii). 51. chenzira, 2012 wl 6721098, at *4. 52. see brown v. f.l. roberts & co., 419 f. supp. 2d 7, 12 (d. mass. 2006) (citing e.e.o.c. v. union independiente de la authoridad de acueductos y alcantarillados de puerto rico, 270 f.3d 49, 56 (1st cir. 2002)). 53. see generally adeyeye v. heartland sweeteners, llc, 721 f.3d 444, 448 (7th cir. 2013) (alleging the validity of someone’s religious sincerity cannot be questioned). anglo-saxon 2022] the syringe that drips money 225 the seventh circuit has gone so far as to implicitly hold that while theologians may be tempted to examine the sincerity of an employee’s belief, the government is prohibited from making such inquiries.54 nonetheless, disproving sincerity is possible. in fallon, the third circuit held an employee’s belief was medical in nature and thereby not protected as a religious belief under title vii.55 there, a hospital employee objected to a vaccination policy, stating he believed vaccines did more harm than good to the body.56 the employee argued this stance was accompanied by a sincerely held belief that one should not harm their own body.57 the court found in favor of the employer, reasoning because the belief was isolated and not accompanied with any other religious teaching, the belief was not sincerely held at a level akin to that of a religious belief.58 while the fallon decision shows disproving sincerity is possible, employers are more likely to prevail on other defenses, such as undue hardship. jurisprudence generally requires the proponent of an allegation, here the employee, to carry the burden of proving part of the case, here the sincerity of their religion. however, title vii places the burden on the employer to disprove such sincerity. courts may reject the general evidentiary principle because of the heightened protections for religion or for various other reasons not explored in this note. some employers, like conway regional health system, have even asked employees requesting religious exemptions from covid-19 vaccination mandates to sign an attestation. these statements provide that the undersigned employee does not and will not use common medications developed from fetal cells, and ultimately help ensure the employee’s claim is actually a sincerely held religious belief. parris kane, conway regional ceo says covid-19 religious exemption isn’t an attempt to shame employees, katv (sept. 14, 2021), https://katv. com/news/local/conway-regional-ceo-says-covid-19-religious-exemption-isnt-an-attempt-to-shameemployees [https://perma.cc/w3e8-9xde]. the list includes, but is not limited to: tylenol, tums, motrin, ibuprofen, benadryl, sudafed, claritin, and many others. id. many courts’ refusals to question sincerity and religious objections are pliable, so it is undetermined whether this approach provides the employer any additional support or if it will hold up to scrutiny if judicially tested. 54. see adeyeye, 721 f.3d at 448-52 (citing united states v. seeger, 380 u.s. 163, 184 (1965)); see also tagore v. u.s., 735 f.3d 324, 328 (5th cir. 2013) (citing moussazadeh v. tex. dep’t of crim. justice, 703 f.3d 781, 790-92 (5th cir. 2012)) (reasoning while the sincerity component is important, courts must use “judicial shyness” when completing the inquiry). 55. see fallon v. mercy catholic med. ctr. of se. pa., 877 f.3d 487, 492 (3d cir. 2017). 56. id. 57. id. 58. see id. the court focused on the fact that the belief was isolated and not accompanied by any other teaching, that it did not deal with imponderable matters like most religions, and that there were no formal signs of a religious belief. id. (citing africa v. commonwealth of pa., 662 f.2d 1025, 1032 (3d cir. 1981)). this framework of questions was not used in previous cases cited within this note, as the courts were virtually unwilling to question the sincerity at all. see adeyeye, 721 f.3d at 448. 226 indiana health law review [vol. 19:217 c. legal claims title vii offers employees two theories to bring discrimination claims: disparate treatment and disparate impact.59 these subsections briefly provide explanations of the prima facie elements of each claim. 1. disparate treatment title vii prohibits employers from taking adverse employment actions against any individual because of their race, color, sex, national origin, or religion.60 disparate treatment requires a showing of intent.61 to demonstrate religious discrimination under a theory of disparate treatment, the employee carries the initial burden of presenting a prima facie showing of religious discrimination.62 the employee must show he or she (1) is in a protected class, (2) was otherwise qualified for the job, (3) was rejected from the position, and (4) either an employee outside of the protected class was selected for the job, or the employer continued searching for employees for the job.63 if the employee meets these elements, the burden shifts to the employer to show a legitimate, nondiscriminatory reason for the action.64 the employee may rebut the employer’s given reason by showing it is pretextual.65 2. disparate impact disparate impact is the second type of claim an employee may bring to show discrimination under title vii.66 “[d]isparate-impact discrimination occurs when an employer uses facially neutral policies or practices that have a 59. 42 u.s.c. § 2000e-2(a); eeoc v. abercrombie & fitch stores, inc., 135 s. ct. 2028, 2032 (2015). 60. 42 u.s.c. § 2000e-2(a); mcdonnell douglas corp. v. green, 411 u.s. 792, 801 (1973). 61. see 42 u.s.c. § 2000e-2(a); see also mcdonnell, 411 u.s. at 804. 62. see mcdonnell, 411 u.s. at 802 (providing a prima facie case for racial discrimination). 63. see id. at 802. a showing under the disparate treatment theory is available for both prospective and current employees. element three of the prima facie case generally means an adverse employment action was taken against the employee. however, the mcdonnell prima facie framework is flexible. it can be used for claims related to hiring, firing, or other actions, and is even used for other statutes, such as the ada. for example, the tenth circuit reworded the framework to conform to the facts of a wrongful termination case, stating the employee must show: “(1) he belongs to a racial minority; (2) that he was qualified for his job; (3) that, despite his qualifications, he was discharged; and (4) that after his discharge the job remained available.” lujan v. n.m. health & soc. servs., 624 f.2d 968, 970 (10th cir. 1980) (citing mcdonnell, 411 u.s. at 802). 64. mcdonnell, 411 u.s. at 802. 65. id. at 804. 66. 42 u.s.c. § 2000e-2(a)(2); eeoc v. abercrombie & fitch stores, inc., 135 s. ct. 2028, 2032 (2015). 2022] the syringe that drips money 227 disproportionately adverse effect on protected groups.”67 disparate impact discrimination does not require a showing of intent.68 the employee need only show the employment practice has a disparate impact on a protected class.69 disparate impact discrimination is generally shown through statistical evidence.70 however, an employee can also make a prima facie case by demonstrating that a reasonable jury could infer a similarly-situated employee not in the protected class would not be adversely impacted by the neutral policy, but they, as an employee of the protected class, are adversely affected.71 once an employee has shown the employment policy creates a disparate impact, the employee may move in one of two ways. first, an employee may show the employer uses an employment practice that causes a disparate impact, and the employer has failed to show the practice is “job related for the position in question and consistent with business necessity.”72 otherwise, an employee may demonstrate they provided the employer with a reasonable alternative to the neutral policy and the employer failed to adopt that alternative.73 d. reasonable accommodation after providing the different types of legal claims an employee may bring under title vii, it is vital to consider reasonable accommodation. unlike other protected classes in title vii, reasonable accommodation claims are available for both disparate impact and disparate treatment religious discrimination cases.74 67. muhammad v. n.y.c. transit auth., 52 f. supp. 3d 468, 485 (e.d. n.y. 2014) (citing ricci v. destefano, 557 u.s. 557, 577-78 (2009)). 68. id. (citing u.s. v. brennan, 650 f.3d 65, 90 (2d cir. 2011)). 69. 42 u.s.c. § 2000e-2(k)(1). 70. ricci, 557 u.s. at 587 (citing conn. v. teal, 457 u.s. 440, 446 (1982)); muhammad, 52 f. supp. 3d at 486 (citing lewis v. n.y.c. transity auth., no. 04-cv-2331 (slt) (mdg), 2014 u.s. dist. lexis 46471 (e.d. n.y. mar. 31, 2014)); see dothard v. rawlinson, 433 u.s. 321, 32930 (1977). 71. muhammad, 52 f. supp. 3d at 486 (citing lewis, 2014 u.s. dist. lexis 46471). 72. 42 u.s.c. § 2000e-2(k)(1)(a)(i). see note, business necessity under title vii of the civil rights acts of 1964: a no-alternative approach, 84 yale l.j. 98 (1974) (providing analysis on the theories of disparate impact and business necessity). the business necessity defense is an important step in analyzing title vii and other anti-discrimination statutes; however, because it is believed most claims arising from vaccination policies will arise under claims that are alleging the employer failed to provide reasonable accommodation, this note looks to focus its analysis solely on reasonable accommodation. further analysis of the business necessity defense is warranted for future notes. 73. 42 u.s.c. § 2000e-2(k)(1)(a)(ii). 74. see eeoc v. abercrombie & fitch stores, inc., 135 s. ct. 2028, 2032 (2015) (citing 42 u.s.c. § 2000e(j) (2012)); see also amina musa, note, ‘a motivating factor’ – the impact of eeoc v. abercrombie & fitch stores, inc. on title vii religious discrimination claims, 61 st. louis l. j. 143, 155 n.87 (2016) (noting title vii religious accommodation claims have seemingly merged with disparate treatment claims). the job necessity defense is only available for disparate 228 indiana health law review [vol. 19:217 once an employee shows religious discrimination, and absent a showing of an undue hardship by the employer, the employer is obligated to provide reasonable accommodation to the policy.75 reasonable accommodation eliminates the conflict between the employee’s religious practice and the employment policy.76 an employee may establish a prima facie case of failure to reasonably accommodate by demonstrating that “(1) he or she has a bona fide religious belief that conflicts with an employment requirement; (2) he or she informed the employer of this belief; and (3) he or she was disciplined for failure to comply with the conflicting employment requirement.”77 determining whether an accommodation is reasonable is a question of fact that should be determined based on the totality of circumstances.78 to determine an accommodation, both the employer and employee should work cooperatively and in good faith.79 nevertheless, the duty to cooperate in good faith does not require the employer to grant the employee’s preferred accommodation, but rather only those that are reasonable.80 it is important to note that while reasonable accommodation and undue hardship are distinct elements, reasonable accommodation is inherently determined in relation to undue hardship.81 for example, the second circuit stated that “the defendant’s burden of persuading the factfinder that the plaintiff’s impact discrimination. see also 42 u.s.c. § 2000e-2(k)(2). 75. see trans world airlines inc. v. hardison, 432 u.s. 63, 66 (1977) (citing 42 u.s.c. § 2000e(j) (1970)); see also 42 u.s.c. § 2000e(j) (2018). unlike the ada, reasonable accommodation is not its own claim under title vii; rather, reasonable accommodation is best understood as a way to move under disparate treatment or disparate impact discrimination. see abercrombie, 135 s. ct. at 2032. 76. muhammad, 52 f. supp. 3d at 483. 77. chalmers v. tulon co. of richmond, 101 f.3d 1012, 1019 (4th cir. 1996) (quoting philbrook v. ansonia bd. of educ., 757 f.2d 476, 481 (2d cir. 1985)). as expressed, an employee must notify their employer that the policy conflicts with their religion before the employee can claim the employer failed to make a reasonable accommodation. 78. robinson v. children’s hosp. boston, no. 14-10263-djc, 2016 wl 1337255, at *6 (d. mass. apr. 5, 2016) (citing e.e.o.c. v. unión independiente de la authoridad de acueductos y alcantarillados de puerto rico, 279 f.3d 49, 56-57 (1st cir. 2002)). 79. cloutier v. costco wholesale corp., 390 f.3d 126, 131 (1st cir. 2004) (citing cloutier v. costco wholesale corp., 311 f. supp. 2d 190, 199 (d. mass. 2004)). 80. patterson v. walgreen co., 727 f. app’x 581, 587 (11th cir. 2018), cert. denied, 140 s. ct. 685 (2020); horvath v. city of leander, 946 f.3d 787, 792 (5th cir. 2020) (citing bruff v. n. miss. health servs., inc., 244 f.3d 495, 501 (5th cir. 2001)); dorit r. reiss & veena b. dubal, influenza mandates and religious accommodation: avoiding legal pitfalls, 46 j.l. med. & ethics 756, 757 (2018). 81. pamela s. karlan & george rutherglen, disabilities, discrimination, and reasonable accommodation, 46 duke l.j. 1, 11-13 (1996). this article looks specifically at the ada; however, the proposition that reasonable accommodation and undue hardship are distinct is applicable to title vii. 2022] the syringe that drips money 229 proposed accommodation is unreasonable merges, in effect, with its burden of showing, as an affirmative defense, that the proposed accommodation would cause it to suffer an undue hardship.”82 e. undue hardship undue hardship is a bedrock principle for many equal employment opportunity (“eeo”) laws. this note considers undue hardship in relation to safety and cost—which inherently includes efficiency. once accommodations are proposed, if the parties are unable to reach an agreement, the employer must show the proposed accommodations would cause an undue hardship.83 under title vii, undue hardship is determined using a de minimis standard.84 that is, if the proposed accommodation would have greater than a de minimis impact on the employer, the accommodation is considered unduly burdensome.85 1. safety considerations a safe work environment may be the most important reason to implement a vaccine mandate. when considering title vii’s de minimis impact standard, 82. borkowski v. valley cent. sch. dist., 63 f.3d 131,138 (2d cir. 1995). but see vande zande v. state of wis. dep’t. of admin., 44 f.3d 538, 542-43 (7th cir. 1995) (stating proposed accommodations that do not pose an undue hardship may still be found unreasonable in certain circumstances). both cases are ada cases but can be compared to title vii. 83. see trans world airlines inc. v. hardison, 432 u.s. 63, 66 (1977) (citing 42 u.s.c. § 2000e(j) (1970); see also 42 u.s.c. § 2000e(j) (2018). reasonable accommodation and undue hardship are distinct elements; however, it is difficult to think of any situation where a court would find a reasonable accommodation also causes an undue hardship. see also karlan & rutherglen, supra note 81, at 6-8. 84. trans world airlines inc., 432 u.s. at 84. there has been some indication that a few justices on the united states supreme court are willing to reconsider the de minimis standard; but all petitions for certiorari have been denied. see patterson, 727 f. app’x at 587; see also small v. memphis light, gas & water, 952 f.3d 821 (6th cir. 2020), cert. denied, 141 s. ct. 1227 (2021); dalberiste v. gle assocs., inc., 814 fed. app’x. 495 (11th cir. 2020), cert. denied, 2021 u.s. lexis 1773 (2021). this note does not look to analyze whether the de minimis standard is an appropriate way to balance an employer’s interests against an employee’s religious freedom. see generally alan d. schuchman, note, the holy and the handicapped: an examination of the different applications of the reasonable-accommodation clauses in title vii and the ada, 73 ind. l.j. 745 (1998) (providing an analysis of whether the de minimis standard is appropriate for title vii religious accommodation). de minimis is defined as “[t]rifling; negligible.” de minimis, black’s law dictionary (11th ed. 2019). 85. trans world airlines inc., 432 u.s. at 84. as previously stated, it is possible a court could determine an accommodation is both reasonable and unduly burdensome; however, this possibility is negligible, and if the court were to find this, it would be obligated to rule in favor of the employer due to its finding of undue hardship. see karlan & rutherglen, supra note 81, at 6-8 (making a similar argument for the ada). 230 indiana health law review [vol. 19:217 “safety considerations are highly relevant in determining whether a proposed accommodation would produce an undue hardship on the employer’s business.”86 courts generally seem to consider the safety of the employee seeking a specific accommodation and their fellow coworkers;87 however, courts have also been willing to allow safety concerns to encompass the public in the healthcare industry.88 virtually no privately implemented vaccine mandates outside of the healthcare industry have been tried in court.89 thus, while this note is focused on manufacturing, it is important to explain how the healthcare industry has dealt with such mandates. in robinson, a healthcare employee refused to obtain the influenza vaccine because it contained pork byproduct, which her islamic faith prohibited her from consuming.90 her employer attempted to reasonably accommodate her by offering an influenza vaccine without pork byproduct, but the employee refused.91 the court found an assessment of public risk would presumably be included in an undue hardship analysis for healthcare workers.92 the court held that retaining the unvaccinated employee would cause an undue hardship because medical evidence not only showed vaccines were the most effective means of preventing the transmission of influenza, but also because the employee would increase the risk of infecting an already vulnerable patient population.93 while there are other hospital-related mandates, many cases challenging such 86. draper v. u.s. pipe & foundry co., 527 f.2d 515, 521 (6th cir. 1975). 87. see bhatia v. chevron u.s.a, inc., 734 f.2d 1382, 1384 (9th cir. 1984) (per curiam); see also e.e.o.c. v. oak-rite mfg. corp., no. ip99-1962-c-h/g, 2001 wl 1168156, at *13 (s.d. ind. aug. 27, 2001) (citing kalsi v. n.y.c. transit auth., 62 f. supp. 2d 745, 748 (e.d. n.y. 1998)). 88. see robinson v. children’s hosp. boston, no. 14-10263-djc, 2016 wl 1337255, at *6 (d. mass. apr. 5, 2016) (citing eeoc informal discussion letter, u.s. equal emp. opportunity comm’n, https://www.eeoc.gov/foia/eeoc-informal-discussion-letter-250 [https://perma.cc/enj4jdly] (last updated apr. 6, 2012) (considering the patient population in its analysis). 89. see generally teri dobbins baxter, employer-mandated vaccination policies: different employers, new vaccines, and hidden risks, 2017 utah l. rev. 885; brian d. abramson, vaccine law in the health care workplace, 12 j. health & life sci. l. 22 (2019); daria koscielniak, note, broadening healthcare personnel’s exemptions to vaccination: will patients pay the ultimate price?, 25 temp. pol. & civ. rts. l. rev. 171 (2016). the articles cited within this footnote are only to provide a few examples of journals discussing mandatory vaccine policies within the healthcare industry. 90. robinson, 2016 wl 1337255, at *3. the employee later confirmed in her deposition that she learned of her religion’s moratorium on all vaccinations the same month she met with hospital officials. id. at *8. 91. id. at *3-4. the employer offered to provide the employee with a pork-free vaccination and a list of all ingredients in the vaccine; however, the employee did not seek to obtain this information. id at *3. 92. id. at *6 (citing eeoc informal discussion letter, supra note 88). 93. id. at *9. 2022] the syringe that drips money 231 mandates have either settled or are still within the discovery stage.94 it is thus necessary to provide other examples of safety considerations outside of vaccine mandates. in bhatia, the employer implemented a policy stating any employee who worked around toxic gases and had facial hair that prevented a gas-tight face seal would need to shave their face and wear a fitted, gas-tight respirator.95 however, one employee’s religious beliefs prohibited the shaving of body hair.96 the court eventually found in favor of the employer, stating undue hardship could be established in two ways: (1) by showing that allowing the employee to work without a gas-tight respirator would increase the possibility that the employer would face lawsuits for violating california occupational safety and health administration standards;97 or (2) that assigning the employee only to projects that did not involve toxic gases would require the employer to make unnecessary predictions and force the employee’s coworkers to assume his share of the work for projects involving such gases.98 the court rationalized its argument, stating that “[a]n employer may prove that an employee’s proposal would involve undue hardship by showing that either its impact on coworkers or its cost would be more than de minimis.”99 furthermore, in kalsi, the employer implemented a policy requiring all employees to wear hard hats at all times while inside maintenance facilities, which conflicted with one employee’s religious belief that required him to wear a turban.100 the court granted summary judgment in favor of the employer, initially stating “[w]here, as here, the proposed accommodation threatens to compromise the safety in the workplace, the employer’s burden of establishing an undue burden is light indeed.”101 the court reasoned that by wearing the turban 94. see douglas j. opel et al., vaccination without litigation—addressing religious objections to hospital influenza-vaccination mandates, 378 new eng. j. med. 785, 786 (2018) (providing a table of some cases involving vaccine mandates in the healthcare industry). 95. bhatia v. chevron u.s.a, inc., 734 f.2d 1382, 1383 (9th cir. 1984) (per curiam). 96. id. 97. id. at 1384. 98. id. 99. id. (citing yott v. n. am. rockwell corp., 602 f.2d 904, 908 (9th cir. 1979), cert. denied, 445 u.s. 928 (1980)). this rule seems to suggest the court is not so much concerned with the health of the individual employee refusing to adhere to the questioned policy as it is with the costs associated with the potential negative health effects. 100. kalsi v. n.y.c. transit auth., 62 f. supp. 2d 745, 748-49 (e.d. n.y. 1998). this policy arose when most employees began wearing “bump caps” instead of hard hats because they felt the bump caps were more comfortable. id. at 749. nevertheless, the transit authority found the protection afforded by the bump caps were at best questionable and decided implementing a requirement for hard hats was necessary to better promote the safety of its employees. id. 101. id. at 758. the court seems to make the proposition that safety considerations lessen the already low de minimis burden and premise this implicit statement on the draper v. u.s. pipe & foundry co. argument that safety considerations are relevant to undue hardship; however, draper never states safety considerations lessen the de minimis requirement, nor has any case made this proposition. see id. (citing draper v. u.s. pipe & foundry co., 527 f.2d 515, 521 (6th cir. 1975)). 232 indiana health law review [vol. 19:217 instead of the hard hat, the plaintiff was at a higher risk of catching fire and electrocution, which would potentially require coworkers to save him and consequently face safety risks of their own.102 thus, kalsi provides employers an example of where potential litigation expenses and potential safety risks to coworkers can cause an undue hardship.103 moreover, in oak-rite the employer required all employees working on the riveting machine to wear full-length pants as a safety precaution;104 however, a prospective employee informed the employer her religion forbid her from wearing attire associated with men and she was required to wear a skirt.105 when the employee sued for religious discrimination, the court found in favor of the employer, stating that there is “an undue hardship (a burden that is more than de minimis) if the proposed accommodation would create any significant safety or legal risks.”106 thus, employers need not show any type of actual injury, but instead only that there is an increased risk of injury if the proposed accommodation were adopted.107 while undue hardship for safety matters is generally not difficult for employers to show, not all employers meet the burden. for example, in draper the employer stated the employee’s proposed accommodations to not work certain saturdays constituted an undue hardship because it would cause the employee’s coworkers to work over eight hours—causing fatigue and increasing the potential risk of injury.108 the court reasoned, however, there was no undue hardship because the employer was a party to a collective bargaining agreement that permitted employees to work over twelve-hour days.109 thus, while the de minimis standard is a low bar for employers to meet, draper shows employers cannot meet their burden simply by invoking potential safety hazards, but rather must have some reasonable basis for refusing the accommodation to meet the de minimis standard.110 safety considerations are relevant and can help show an undue hardship; however, they do not lessen the de minimis standard. 102. id. at 760. this court also seemed to recognize they are not concerned with the wellbeing of the plaintiff if they are harmed by refusing to conform with the policy, but rather with the cost of potential litigation that could ensue from the injury and the wellbeing of the employee’s coworkers. see id. 103. see id. 104. e.e.o.c. v. oak-rite mfg. corp., no. ip99-1962-c-h/g, 2001 wl 1168156, at *5-6 (s.d. ind. aug. 27, 2001). the employer’s expert witness observed wearing a dress would increase the possibility of entanglement in moving parts and cuts to exposed skin; however, the expert stated his observation also depended in part on fit and material of the skirt. id. at *12. 105. id. at *6-7. 106. id. at *12. 107. see id. at *13. 108. draper v. u.s. pipe & foundry co., 527 f.2d 515, 517-21 (6th cir. 1975). 109. id. at 521-22. 110. id. at 521-23. 2022] the syringe that drips money 233 2. economic costs in its leading case defining the de minimis standard, the united states supreme court showed just how easy it is for an employer to establish undue hardship. in trans world airlines, inc., an employee informed his employer of his religious observance of the sabbath and asked that the employer not schedule him on saturdays.111 the employer refused to grant the request, stating it would either have to employ someone not regularly scheduled to work on saturdays and pay premium wages or fill the employee’s position with a supervisor or other employee, consequently unmanning a separate operation.112 the supreme court found in favor of the employer, stating the accommodations would either lead to a loss in efficiency or higher wages, both of which would require the employer to bear more than a de minimis cost.113 interestingly, the dissent pointed out the record was devoid of any efficiency loss the employer may face, and the only costs the employer would have incurred were three $150 payments over a period of three months.114 the seventh circuit implicitly echoed the united states supreme court, stating their circuit decisions allow the “most modest burdens on employers” to overcome the de minimis standard.115 the seventh circuit also found transferring an employee to a new city and incurring costs to retrain that employee for a new position would constitute an undue hardship.116 in contrast, the sixth circuit held a shift change allowing an employee to observe the sabbath did not cause an undue hardship on the employer, even though the employer would have to reschedule disgruntled employees.117 the sixth circuit reasoned that “an employer does not sustain his burden of proof merely by showing that an accommodation would be bothersome to administer or disruptive to the operating routine.”118 thus, while the de minimis standard is a low bar for employers, the sixth circuit has shown the fact sensitive nature of title vii cases can cause 111. trans world airlines, inc. v. hardison, 432 u.s. 63, 67-68 (1977). 112. id. at 68-69. it should also be noted the employer indicated it would have granted the accommodation if not for a collective bargaining agreement that prohibited such an accommodation due to seniority protocols. 113. id. at 84. cf. 29 c.f.r. § 1605.2 (2021) (providing the e.e.o.c.’s interpretation of premium wages in conjunction with the de minimis standard). 114. trans world airlines, inc., 432 u.s. at 92 n.6 (marshall, j., dissenting). when adjusted for inflation, $150 from 1970 would amount to approximately $1,000 in 2021. 115. see e.e.o.c. v. oak-rite mfg. corp., no. ip99-1962-c-h/g, 2001 wl 1168156, at *5-6 (s.d. ind. aug. 27, 2001) (citing ryan v. u.s. dep’t. of justice, 950 f.2d 458, 461-62 (7th cir. 1991)). 116. ryan, 950 f.2d at 462. 117. draper v. u.s. pipe & foundry co., 527 f.2d 515, 520-23 (6th cir. 1976). notably, the employer in draper was also subject to a collective bargaining agreement; however, the agreement allowed the employer to assign employee shifts without regard to seniority. id. at 518. 118. id. at 520 (citing cummins v. parker seal co., 516 f.2d 544, 551 (6th cir. 1975)) (finding objections from coworkers alone do not constitute an undue hardship). 234 indiana health law review [vol. 19:217 different results for cases alleging similar facts and undue hardships. as previously stated, an employer can show an undue hardship simply by arguing the proposed accommodation may, but not necessarily will, lead to a safety hazard.119 this principle also extends to economic costs and inefficiencies. for example, the ninth circuit held that potential costs, specifically potential legal costs caused from a potential violation of california occupational safety and health administration standards, was enough to cause an undue hardship.120 furthermore, in kalsi, the court held that potential workers’ compensation claims resulting from a possible catastrophic safety hazard constituted an undue hardship.121 thus, both trivial and potential costs can trigger a finding of undue hardship. finally, cost is directly related to efficiency. as previously stated, the united states supreme court held a loss of efficiency and three minor payments constituted an undue hardship.122 the fifth circuit seemingly expanded the supreme court’s holding, finding an accommodation that creates a burden on efficiency, whether or not the accommodation would bear any monetary costs, can constitute an undue hardship.123 however, the ninth circuit has stated that complete harmony among employees is not title vii’s objective, implicitly holding animosity alone does not constitute an undue hardship.124 nonetheless, if the accommodation causes employees to became so hostile as to cause greater than a de minimis inefficiency, the accommodation would almost certainly cause an undue hardship.125 iv. applying reasonable accommodation and undue hardship to the manufacturing sector before a court undertakes an undue hardship analysis, the following must occur: (1) a manufacturing facility implements a vaccine mandate; (2) an employee refuses to adhere to the vaccine mandate on religious grounds; (3) both parties undergo an interactive process to determine a potential reasonable 119. kalsi v. n.y.c. transit auth., 62 f. supp. 2d 745, 760 (e.d. n.y. 1998). 120. see bhatia v. chevron u.s.a, inc., 734 f.2d 1382, 1384 (9th cir. 1984) (per curiam). 121. kalsi, 62 f. supp. 2d at 760. the court furthered its analysis, stating the potential for incurred costs associated with a less than catastrophic injury could also constitute an undue hardship in certain circumstances. id. so long as the potential, less than catastrophic injury could lead to a greater than de minimis cost, an undue hardship would exist. accord trans world airlines, inc. v. hardison, 432 u.s. 63, 84 (1977). 122. trans world airlines inc., 432 u.s. at 84. 123. howard v. haverty furniture cos., 615 f.2d 203, 206 (5th cir. 1980) (citing trans world airlines inc., 432 u.s. at 84). 124. peterson v. hewlett-packard co., 358 f.3d 599, 607-08 (9th cir. 2004) (citing franks v. bowman transp. co., 424 u.s. 747, 775 (1976)); see also draper v. u.s. pipe & foundry co., 527 f.2d 515, 520 (6th cir. 1976) (citing cummins v. parker seal co., 516 f.2d 544, 550 (6th cir. 1975)) (finding objections from coworkers alone does not constitute an undue hardship). 125. draper, 527 f.2d at 520 (citing cummins, 516 f.2d at 551). 2022] the syringe that drips money 235 accommodation; and (4) the parties fail to agree on a reasonable accommodation. reasonable accommodation and undue hardship are fact sensitive, so this section discusses potential accommodations that may be considered by the manufacturing industry while also focusing its analysis on multiple factors that may tempt a court to find an undue hardship. thus, this section analyzes a few potential accommodations, the transmission of the virus, vaccine safety and effectiveness, economic burdens, coworker considerations, and the type of product the manufacturer produces. a. potential accommodations the general consensus among the scientific community is that masks work as a physical barrier to the spread of many communicable diseases and thus are the best option to limit disease transmission, second only to vaccination.126 social distancing, or the act of remaining a certain number of feet away from one another, has also been used as a mitigation technique in previous pandemics.127 finally, the use of protective clothing other than masks may be a potential accommodation for manufacturers who produce certain dangerous objects. nevertheless, while these accommodations may seem reasonable, they all succumb to similar flaws. when analyzing social distancing and protective clothing, practical complications arise in the manufacturing setting. for example, most manufacturing employees work on an assembly line, making it almost impossible for employers to properly distance employees without measures that would lead to greater than a de minimis cost.128 even if the manufacturer could ensure social distancing on the assembly line, it would be nearly impossible to implement the measures during the lunch hours or when employees are simply moving throughout the rest of the building.129 additionally, protective clothing that would 126. cf. robert c. reiner jr. et al., modeling covid-19 scenarios for the united states, 27 nature med. 94 (2021) (analyzing how universal mask use on the national level could save hundreds of thousands of lives in the united states). 127. hatchett et al., supra note 6, at 7582. 128. social distancing for manufacturers: is it possible?, glob. elec. serv., inc., https://gesrepair.com/social-distancing-for-manufacturers-is-it-possible/ [https://perma.cc/phu9jdz6] (last visited feb. 1, 2021). 129. evidence from the cdc on sars-cov-2 suggests if an unvaccinated individual has close contact with an infected person for a total of fifteen minutes in a twenty-four-hour period, whether in continuous or interval periods, they could contract the virus and should self-isolate. coronavirus disease 2019 (covid-19): appendices, ctr. disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracingplan/appendix.html#contact [https://perma.cc/g8p6-pyga] (last visited july 21, 2021). this time may differ between each communicable disease. those who are considered fully vaccinated or who have tested positive for covid-19 in the past three months need not self-isolate after a sarscov-2 exposure unless they develop symptoms. when you’ve been fully vaccinated, ctr. disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully236 indiana health law review [vol. 19:217 reduce or eliminate the risk of puncture wounds or cuts, including gloves, long pants, and other similar clothing, may create additional safety hazards or inefficiencies. for example, if the proposed protective clothing has an increased probability of getting caught in a machine, an employer could show the accommodation is not reasonable.130 protective clothing may also reduce mobility for some workers, thereby slowing production and creating inefficiencies.131 it is also unclear how much this type of clothing would cost. simple cotton products are unlikely to provide protection against major puncture wounds, making it likely that the manufacturer would need to purchase more durable clothing, which could itself lead to a greater than de minimis cost. next, when considering all the potential accommodations, each could be considered unduly burdensome on employers. while each option may be somewhat effective in preventing the spread of disease, vaccines offer the greatest protection. as stated, mask use is an effective measure, but the medical consensus is that masks are second best to vaccines. nevertheless, with the give-and-take nature of reasonable accommodation, there is an argument that, although not the most effective, mask use and other similar accommodations would provide enough protection and thus should be upheld. however, courts have held that forcing an employer to test a hypothesis as to whether an accommodation is reasonable in light of the employer’s policy can cause an undue hardship.132 in other words, a court is unlikely to test, or unwilling to force an employer to test, whether a specific accommodation provides enough protection when medical studies show vaccines are the most effective.133 thus, if a vaccine is approved and recommended by the fda and cdc, under the de minimis standard it is likely anything less than vaccination would create an undue hardship so long as factors discussed later in the note are met.134 nonetheless, manufactures cannot automatically discard all requested accommodations. take, for example, a hypothetical disease that can be treated by two totally different vaccines. one vaccine contains a pork byproduct, prohibited by the islamic and jewish faiths, or cloned fetal cells, prohibited by the christian faith, while the other vaccine does not contain either of the potentially vaccinated.html [https://perma.cc/yj4u-e7fy] (last visited july 27, 2021). 130. see e.e.o.c. v. oak-rite mfg. corp., no. ip99-1962-c-h/g, 2001 wl 1168156, at *13 (s.d. ind. aug. 27, 2001). 131. see anna-katrina shedletsky, the covid-19 problems that will force manufacturing to innovate, forbes (may 5, 2020, 2:38 pm), https://www.forbes.com/sites/ annashedletsky/ 2020/05/05/the-covid-19-problems-that-will-force-manufacturing-to-innovate/?sh=3782445130d0 [https://perma.cc/lq8y-u3ml] (noting gloves may reduce finger dexterity for electronic manufacturing employees). 132. bhatia v. chevron u.s.a, inc., 734 f.2d 1382, 1384 (9th cir. 1984) (per curiam); oakrite mfg. corp., 2001 wl 1168156, at *14. 133. see oak-rite mfg. corp., 2001 wl 1168156, at *14; see also robinson v. children’s hosp. boston, no. 14-10263-djc, 2016 wl 1337255, at *9 (d. mass. apr. 5, 2016) (providing an example where the court looked towards medical evidence to help reach its conclusion). 134. see infra text accompanying notes 137-78. 2022] the syringe that drips money 237 objectionable materials. with certain exceptions, it is almost unquestionable that an employee requesting a religious accommodation to receive the vaccine that does not contain the pork byproduct or cloned fetal cells would be considered reasonable. the employee is not asking to remain unvaccinated; rather, they are agreeing to adhere to the precise employment policy in exchange for a specific vaccine. thus, this accommodation should lean in favor of the employee because they will remain vaccinated. of course, the previous argument relies on many factors to be discussed later in this note.135 if the employer discovers the alternative vaccine is significantly less effective or costlier, an employer may be able to show this request would cause an undue hardship, although they should still be inclined to grant the accommodation. the fact that the vaccine is available means the fda and cdc authorized or approved and recommended its use; thereby allowing the employee, employer, and court to infer its effectiveness in preventing the specific disease.136 this alone should allow the accommodation to lean in favor of the employee because in the end, the employee is still getting a vaccine. therefore, even if the other vaccine is less effective or costlier, the employer must question whether the expense of litigation is worth denying an employee seeking a good faith accommodation and continuing to adhere to the employment policy. b. transmission of the virus before evaluating how cost and safety will impact a manufacturer’s undue hardship analysis, the employer must evaluate the disease’s transmission.137 two components of transmission should be considered: the mode and the rate. when considering the mode of transmission, compare influenza or sars-cov-2 to hepatitis b. both influenza and sars-cov-2 spread in similar manners: (1) through droplets containing the respective virus that are inhaled or land in the nose or mouth, (2) through human contact, and (3) by touching surfaces that contain a live virus.138 in contrast, hepatitis b is spread through bodily fluids such as blood and semen, generally by sexual contact, sharing injection equipment, or during childbirth.139 rate of transmission is also relevant. one method to determine the rate of transmission is through the disease’s r0, which represents the average number of 135. see infra text accompanying notes 137-78. 136. this statement presumes the vaccine was approved rather than provided emergency use authorization. 137. this section only considers person-to-person transmission. 138. similarities and differences between flu and covid-19, ctr. disease control & prevention, https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm#:~:text=both%20covid%% 2 0 2 d 1 9 % 2 0 a n d % % 2 0 2 0 f lu ,fever% 2 0 or%2 0 fee l in g % 2 0 f e v e r i s h % 2 fc h i l l s [https://perma.cc/9evg-vgx5] (last visited jan. 30, 2021). 139. hepatitis b, ctr. disease control & prevention, https://www.cdc.gov/hepatitis/hbv/ index.htm#:~:text=hepatitis%20b%20is%20spread%20when,mother%20to%20baby%20at%20 birth [https://perma.cc/wj7j-tsae] (last visited oct. 29, 2020). 238 indiana health law review [vol. 19:217 additional people infected by each infected person.140 compare influenza and sars-cov-2 to measles. the median r0 of seasonal influenza is estimated to be 1.28.141 the average r0 of sars-cov-2 is approximately 3.28.142 in contrast, the r0 of measles is generally cited at 12 to 18.143 from the provided values, measles is clearly spread much easier than both influenza and sars-cov-2. nevertheless, simply stating the vpd spreads easily is not enough. the employer will need to explain how the mode and rate of transmission of the vpd will impact their workplace. specifically, the employer must show how the vpd would spread among employees while acting within the scope of employment.144 when considering how a specific vpd is transmitted, it is unlikely a manufacturer could mandate that employees obtain a hepatitis b vaccine. as hepatitis b spreads through bodily fluids,145 it is highly unlikely any activity among manufacturing employees acting within the scope of their employment would cause vpd transmission. in contrast, influenza and sars-cov-2 spread through droplets containing live virus, human contact, and touching a surface with live virus.146 a simple cough or sneeze could transmit the vpds to fellow coworkers. thus, it is much more likely that a manufacturer could move onto economic and safety arguments to show an undue hardship for influenza and sars-cov-2 as compared to hepatitis b due to the modes of transmission. the rate of transmission has a similar analysis. measles spreads much quicker when compared to influenza and sars-cov-2. however, measles may spread quicker, but the number of reported cases among the vpds are just the opposite.147 this is because the vast majority of americans are vaccinated against 140. r0 is pronounced “r naught” and is a mathematical term that gauges how easily the specific disease spreads. vanessa bates ramirez, what is “r-naught”? gauging contagious infections, healthline, https://www.healthline.com/health/r-nought-reproduction-number [https:// perma.cc/jp4b-uxf5] (last updated apr. 20, 2020). for example, if the r0 is 4, one infected person will, on average, infect four other people. see id. 141. matthew biggerstaff et al., estimates of the reproduction number for seasonal, pandemic, and zoonotic influenza: a systematic review of the literature, 14 bmc infectious diseases, sept. 2014, at 1, 10. 142. ying liu et al., the reproductive number of covid-19 is higher compared to sars coronavirus, 27 j. travel med., mar. 2020, at 1, 1. the delta variant, also known as the b.1.617.2 variant, is estimated to have an r0 of 6 to 7. talha khan burki, lifting of covid-19 restrictions in the uk and the delta variant, 9 lancet respiratory med. e85, e85 (2021). 143. paul l. delamater et al., complexity of the basic reproduction number (r0), 25 emerging infectious diseases, jan. 2019, at 1, 3. but see fiona m. guerra et al., the basic reproduction number (r0) of measles: a systematic review, 17 lancet infectious diseases e420, e424 (2017) (finding the measles r0 could range from 3.7-203.3). 144. see generally arguello v. conoco, inc., 207 f.3d 803 (5th cir. 2000); see also wilson v. joma, inc., 537 a.2d 187, 189 (del. 1988); hurlow v. managing partners, inc., 755 n.e.2d 1158 (ind. ct. app. 2001). all cases cited provide an example of how to determine scope of employment. 145. hepatitis b, supra note 139. 146. similarities and differences between flu and covid-19, supra note 138. 147. see measles cases and outbreaks, ctr. disease control & prevention, 2022] the syringe that drips money 239 measles as children, which has allowed society to reach heard immunity.148 in contrast, estimates for adult vaccination coverage was 48.4% for influenza during the 2019-2020 flu season and is at 59.4% of the total population for full protection against sars-cov-2, neither of which are enough to achieve herd immunity.149 thus, even though measles spreads easier, influenza or sars-cov2 would impact a manufacturer at greater levels because immunity levels are much less, thereby making it reasonable for them to implement vaccine mandates for influenza and sars-cov-2 but not for measles. both the mode and rate of transmission arguments will be premised on an evaluation as to what percentage of the employees are requesting an accommodation to the vaccine policy and how many employees are already vaccinated. for example, if 95% of the workforce is already vaccinated for influenza or sars-cov-2, it will be much more difficult for an employer to show the 5% of employees who are requesting certain accommodations pose any reasonable threat to burdening the employer with greater than a de minimis cost. nonetheless, because manufacturers, lawyers, and courts are generally not medical experts, and because an evaluation into what percentage of the workforce needs to be vaccinated against a specific disease to prevent substantial harm is highly scientific, this evaluation will likely need to be considered by immunologists, other medical professionals, or through other expert testimony in court. the mode and rate of transmission are the most important considerations in undue hardship analysis. if the vpd is unlikely to spread among employees, other practical considerations, such as not granting an accommodation, are unreasonable. of course, the employer may still mandate a vaccine, but because the vpd is unlikely to spread, the employer will have a difficult time arguing it cannot grant a reasonable accommodation. while courts are willing to find https://www.cdc.gov/measles/cases-outbreaks.html [https://perma.cc/6m9q-dq3b] (last visited oct. 30, 2020); see also disease burden of influenza, ctr. disease control & prevention, https://www.cdc.gov/flu/about/burden/index.html#:~:text=while%20the%20impact% 20of%20flu,61%2c000%20deaths%20annually%20since%202010 [https://perma.cc/24xm-ln 5m] (last visited oct. 30, 2020). these statistics are not meant to reflect the importance of one vaccine over the other. in fact, recent outbreaks of measles reiterate the importance of continuing vaccination against the disease. see michael gold & tyler pager, new york suburb declares measles emergency, barring unvaccinated children from public, n.y. times (mar. 26, 2019), https://www.nytimes.com/2019/03/26/nyregion/measles-outbreak-rockland-county.html [https://perma.cc/5bn7-l2tp]. 148. measles, mumps, and rubella, ctr. disease control & prevention, https://www.cdc. gov/nchs/fastats/measles.htm [https://perma.cc/m26b-v4pw] (last visited jan. 30, 2021). 149. flu vaccination coverage, united states, 2019-20 influenza season, ctr. disease control & prevention, https://www.cdc.gov/flu/fluvaxview/coverage-1920estimates.htm [https://perma.cc/y2jv-g5ra] (last visited jan. 30, 2021); covid-19 vaccinations in the united states, ctr. disease control & prevention, https://covid.cdc.gov/covid-data-tracker/# vaccinations_vacc-people-onedose-pop-5yr [https://perma.cc/ua88-uhuz] (last visited dec. 2, 2021). 240 indiana health law review [vol. 19:217 potential costs and safety hazards to be an undue hardship, the line must be drawn at some point. thus, even if the potential costs or safety hazards of a specific vpd outbreak may be enormous, a court should not find an undue hardship when a vpd is unlikely to spread among employees while acting within the scope of employment. c. vaccine safety and effectiveness after determining whether the vpd is likely to spread among employees while acting within the scope of employment, it is necessary to consider the vaccines overall safety and effectiveness. however, because it is unlikely that manufacturers would have any expertise in immunology, they should make this consideration based on fda approval and cdc recommendation.150 potential vaccines are put through intense clinical trials that analyze the vaccine’s safety and efficacy or effectiveness.151 the results from these trials guide the fda’s decision on whether to approve the vaccine. presumably, if the vaccine is shown to be unsafe or ineffective, the fda would not approve the vaccine. however, this analysis may change in the case of vaccines given an emergency use authorization (“eua”). an eua vaccine is not approved by the fda, but rather is authorized for use due to exigent circumstances, such as lack of other adequate treatments for the disease.152 the fda is required by statute, with limited exception, to ensure recipients of an eua vaccine are “informed of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”153 notably, only providers, recipients, and the department of health and human services are explicitly addressed—not private employers.154 little judicial guidance is given on this statute;155 however, in the absence of presidential waiver, one court allowed the department of defense to only administer an eua vaccine on a voluntary 150. from a purely economic standpoint, it seems that even if an employee were to suffer some type of adverse reaction to a vaccine, the employer could be exonerated from liability under the national vaccine injury compensation program. 42 u.s.c. §§ 300aa-10 et seq. such analysis goes beyond the scope of this note and further research is warranted. 151. vaccine efficacy is a figure that is determined in controlled clinical trials, while vaccine effectiveness is determined once the vaccine has been approved and is available to the general public. efficacy and effectiveness, immunisation advisory ctr., https://www.immune.org.nz/ vaccines/efficiency-effectiveness#:~:text=vaccine%20efficacy%20and%20effectiveness%20 are,use%20in%20the%20general%20population [https://perma.cc/by2k-c5kz] (last updated jan. 2020). 152. 21 u.s.c. § 360bbb-3(b)-(c). 153. id. at § 360bbb-3(e)(1)(a)(i)(iii). 154. see id. 155. but see complaint, legaretta v. macias, no. 2:21-cv-00179 (d. n.m. feb. 28, 2021) (providing an example of a recent challenge of a mandated eua vaccine). 2022] the syringe that drips money 241 basis.156 since the fda presumably only approves vaccines that data shows to be safe and effective, manufacturers should not weigh this consideration too heavily. nonetheless, a court may question what rate of effectiveness is necessary for the employer to mandate such a policy. for example, if a vaccine is only 40% effective, is the employer’s intrusion justified? interestingly, the influenza vaccine only prevents 40%-60% of flu related illnesses and is considered one of the least effective vaccines on the market.157 despite this, the cdc continues to recommend that everyone, except in extreme circumstances, receive the influenza vaccine each year because studies estimate the vaccine annually prevents millions of influenza-related illnesses, medical visits, hospitalizations, and deaths.158 if a specific vaccine prevents medical visits, illnesses, hospitalizations, and deaths, it can be reasoned that a high rate of vaccination among employees would, at minimum, slow the spread or lessen the impact of the vpd. if the spread of the disease is slowed, it could reduce disease-related costs and inefficiencies. in contrast, low levels of vaccination among employees could force employers to bear more than a de minimis cost, pushing the court to rule in favor of undue hardship.159 d. economic consequences of the questioned disease once the employer has shown the specific vpd is reasonably likely to spread among employees, they can then turn to other important factors such as cost. one study has found employees who contract influenza and experience symptoms will miss approximately 3.5 workdays in a given week.160 this not only costs employers in paid sick leave, but also leads to a decrease in efficiency and approximately $11.2 billion in total economic burden.161 moreover, sars-cov-2 156. doe v. rumsfeld, no. 03-707 (egs), 2005 u.s. dist. lexis 5573, at *2-3 (d. d.c. april 6, 2005). see 10 u.s.c. § 1107a(a) (providing the president the ability to waive the choice requirement only (1) for those in the armed forces and (2) in specific circumstances). 157. vaccine effectiveness: how well do the flu vaccines work?, ctr. disease control & prevention, https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm [https://perma.cc/sj3dtfy7] (last visited nov. 4, 2020). the percentages are only correct when the flu vaccine is wellmatched to the flu strand circulating that year. id. while the influenza vaccine is not highly effective in preventing illness, it does reduce severity if infected. see robert g. deiss et al., vaccine-associated reduction in symptom severity among patients with influenza a/h3n2 disease, 33 vaccine 7160, 7166 (2015) (providing analysis only on the a/h3n2 influenza strain). 158. vaccine effectiveness: how well do the flu vaccines work?, supra note 157. 159. see bhatia v. chevron u.s.a., inc., 734 f.2d 1382, 1384 (9th cir. 1984) (per curiam); see also howard v. haverty furniture cos., inc., 615 f.2d 203, 206 (5th cir. 1980) (citing trans world airlines, inc. v. hardison, 432 u.s. 63, 84 (1977)) (noting inefficiencies without monetary burdens can cause an undue hardship). 160. van warmer et al., supra note 25. these missed days amount to approximately 20.1 million days in lost productivity. putri et al., supra note 26. 161. putri et al., supra note 26. 242 indiana health law review [vol. 19:217 is expected to shrink the united states economy by approximately $7.9 trillion over the next decade.162 while not every vpd ravages the economy on an annual basis, these figures show just how devastating certain vpds can be for employers. the above figures do not reflect how vpds impact manufacturers directly, but when considering the de minimis standard, it seems a court examining these astounding costs would find in favor of the employer. for example, the united states supreme court found that three $150 payments constituted an undue hardship.163 furthermore, the fifth circuit went as far to say that an inefficiency, even without any monetary costs, can cause an undue hardship.164 both of these holdings must also be read in conjunction with the fact that most courts find potential costs, both from litigation and everyday losses in productivity, can cause an undue hardship.165 it seems without question that potential costs or inefficiencies associated with paid sick leave, short-term disability, or even shutting down the manufacturing plant, alongside a slew of other costs should point towards an undue hardship. employers can also show vaccine mandates in the healthcare setting have decreased absenteeism of employees,166 providing employers a valuable efficiency argument. of course, a mandatory vaccine policy will not eliminate all costs or inefficiencies, but it will at least be a step towards seeing a great reduction.167 e. coworker considerations the assembly line is a key function of the manufacturing industry, but it is not conducive to social distancing.168 employees are constantly near one another, making it easier to spread many communicable diseases. while close proximity alone may not constitute an undue hardship, one court has noted where “the proposed accommodation threatens to compromise the safety in the workplace, the employer’s burden of establishing an undue burden is light indeed.”169 therefore, any other showing, such as the fact that the close proximity leads to a higher chance of disease transmission, thus leading to higher costs and inefficiencies, will likely allow the employer to meet its burden. 162. letter from philip l. swagel to hon. charles e. schumer, supra note 5. 163. trans world airlines inc., 432 u.s. at 92 n.6 (marshall, j., dissenting). 164. howard, 615 f.2d at 206, (citing trans world airlines inc., 432 u.s. at 84). 165. see bhatia v. chevron u.s.a., inc., 734 f.2d 1382, 1384 (9th cir. 1984) (per curiam). 166. john frederick et al., protecting healthcare personnel in outpatient settings: the influence of mandatory versus nonmandatory influenza vaccination policies on workplace absenteeism during multiple respiratory virus seasons, 39 infection control & hosp. epidemiology 452, 457 (2018). 167. see id. 168. see supra text accompanying notes 128-29. 169. kalsi v. n.y.c. transit auth., 62 f. supp. 2d 745, 758 (e.d. n.y. 1998). but see discussion supra note 101. 2022] the syringe that drips money 243 it could also be argued the close proximity makes manufacturing employees vulnerable to contracting diseases, thus constituting an undue hardship.170 for instance, tyson foods is being sued because of the alarming spread of sarscov-2 among employees on the assembly line, forcing the company to shut down plants to help slow the spread of the disease and prevent further deaths of employees who contracted the disease at work.171 the tragedy at tyson foods indicates how vulnerable assembly line employees are to contracting and spreading communicable diseases. this vulnerability—a consideration of the robinson court—should also be considered by manufacturers. of course, there is an argument that because robinson focused its analysis on the patient population rather than the employee’s coworkers or the employee herself,172 the case is not applicable to the manufacturing sector. the previous proposition does have merit; however, this note focuses specifically on the use of the word “vulnerable.”173 the lack of social distancing within assembly line facilities likely increases viral transmission among employees. thus, when analyzing vulnerability, employers and courts should find in favor of vaccine mandates within manufacturing facilities. an employer may also need to consider animosity among coworkers that could arise if a group of employees view the vaccine exemption as a threat to their wellbeing. as previously stated, courts have long held employee objections to a coworker’s accommodation alone do not constitute an undue hardship.174 thus, the employer would need to show the coworker’s objection to the accommodation could lead to an inefficiency causing an undue hardship. for example, the fifth circuit held a decline in morale by depriving coworkers of a shift preference because of an employee’s requested accommodation constituted an undue hardship.175 while employee animosity can be used to show undue hardship, it is unnecessary for the employer to meet its burden. employers should be able to show safety hazards, other practical inefficiencies, and potentially enormous costs, and thus should only examine coworker considerations in the rarest of circumstances. 170. see robinson v. children’s hosp. boston, no. 14-10263-djc, 2016 wl 1337255, at *9 (d. mass. apr. 5, 2016). 171. families of 3 dead workers sue tyson foods over coronavirus outbreak, fortune (june 26, 2020, 5:27 am), https://fortune.com/2020/06/26/ tyson-foods-coronavirus-lawsuit/ [https://perma.cc/h5bz-lpaw]. 172. robinson, 2016 wl 1337255, at *9. 173. id. 174. peterson v. hewlett-packard co., 358 f.3d 599, 607-08 (9th cir. 2004) (citing franks v. bowman transp. co., 424 u.s. 747, 775 (1976)); draper v. u.s. pipe & foundry co., 527 f.2d 515, 520 (6th cir. 1976) (citing cummins v. parker seal co., 516 f.2d 544, 551 (6th cir. 1975)). 175. brener v. diagnostic ctr. hosp., 671 f.2d 141, 146-147 (5th cir. 1982). but see opukuboateng v. cal., 95 f.3d 1461, 1473-74 (9th cir. 1996) (coming to a different result on similar facts). an in-depth analysis regarding coworker morale is beyond the scope of this note. but see generally lisa e. key, co-worker morale, confidentiality, and the americans with disabilities act, 46 depaul l. rev. 1003, 1011-22 (1997). 244 indiana health law review [vol. 19:217 f. products the manufacturer produces another factor that a court may use to determine whether an undue hardship exists in the manufacturing sector is the type of products produced within a specific manufacturing plant. take, for example, two manufacturers: manufacturer a produces plastic and cardboard widgets and manufacturer b produces sharp, metal widgets. now consider the outcomes of two separate religious discrimination lawsuits that follow when both manufactures implement a new vaccination policy requiring all employees to obtain the tdap vaccine which, among other things, protects against tetanus.176 potential safety hazards and increased costs, including litigation or productivity costs, can cause an undue hardship.177 if an employee were to be injured while acting within the scope of employment and contract tetanus, an employer’s liability could be enormous. for example, the court may find the employer liable for medical costs. one study found medical costs associated with tetanus could range from $22,229 to $1,024,672.178 this potential cost would almost certainly cause an undue hardship. nevertheless, the associated costs may only cause an undue hardship for one of the hypothetical manufacturers. while puncture wounds may be likely for employees working for manufacturer b because of its production of sharp, metal widgets, they are unlikely for employees working for manufacturer a because of its production of plastic and cardboard widgets. since puncture wounds would be unlikely for manufacturer a’s employees, contracting tetanus while acting within the scope of employment would also be unlikely. therefore, because contracting tetanus while working for manufacturer a is unlikely, a court should find manufacturer a’s de minimis cost analysis is too far-fetched to serve any legitimate business interest. the same court should rule in favor of manufacturer b because of the reasonable possibility that an employee could contract tetanus and incur major medical costs. an evaluation into the types of products the manufacturer produces will only be necessary for certain diseases. for example, it would be unreasonable to enter 176. tdap (tetanus, diphtheria, pertussis) vis, ctr. disease control & prevention, https://www.cdc.gov/vaccines/hcp/vis/vis-statements/tdap.html [https://perma.cc/zt4r-84ar] (last visited october 28, 2020). tetanus is caused by a toxin created by bacterial spores called clostridium tetani—found in soil, dust, and animal feces—which can enter the body through puncture wounds and other cuts. tetanus, mayo clinic, https://www.mayoclinic.org/diseasesconditions/tetanus/symptoms-causes/syc-20351625 [https://perma.cc/xh3a-n7mm] (last visited october 28, 2020). tetanus vaccines can be obtained within a specified period after the injury, but this hypothetical does not recognize this as a limiting factor because (1) the religious objection would still be an obstacle after the injury occurred and (2) some similar disease in the future may only be prevented from a vaccine injected before the injury. 177. see kalsi v. n.y.c. transit auth., 62 f. supp. 2d 745, 760 (e.d. n.y. 1998). 178. see cynthia yen et al., missed opportunities for tetanus postexposure prophylaxis— california, january 2008-march 2014, 64 morbidity & mortality wkly. rep. 243 (2015) (providing an analysis of fifteen patients who contracted tetanus). 2022] the syringe that drips money 245 this analysis for a disease such as influenza because the disease predominately spreads through person-to-person transmission. nonetheless, the comparison between manufacturers a and b is an important reminder of why title vii lawsuits must be considered on a case-by-case basis. v. best steps moving forward at minimum, manufacturers should consider vaccine mandates for certain vpds. manufacturers are unquestionably key to a healthy economy. without manufacturers being able to make products, truckers are unable to carry out shipments, retailers cannot make sales, hospitals are unable to acquire supplies, and consumers are unable to purchase certain goods. these economic tolls indirectly lead to psychological phenomena. for example, at the beginning of the sars-cov-2 pandemic, the united states, japan, and australia saw panic buying of toilet paper, and the united kingdom, france, and china saw the same occur with face masks—depleting and straining the supply chain.179 these stresses were in part fueled by manufacturing closures because of viral spread within facilities. thus, while jacobson will not persuade a court to act in favor of a manufacturer, the court’s idea of the “social compact” between citizens provides manufacturers a moral argument to at least consider implementing such a mandate.180 nevertheless, even with the likelihood of success in title vii challenges to vaccine mandates, employers may still approach the subject with hesitancy. this hesitancy may arise for different reasons, but the ever-increasing cost of litigation will undoubtedly be at the forefront of the employer’s mind. thus, before implementing a vaccine mandate, employers may consider the art of persuasion to achieve high levels of vaccination among employees. employers could persuade employees to obtain a vaccine by sponsoring seminars featuring local health professionals to discuss the importance of vaccines, providing free vaccines for employees if insurance or the government does not cover the costs, and offering on-site vaccines as doses are made available. another interesting option may be to incentivize employees to obtain a vaccine by offering a small stipend or paid time off upon proof of a final dose.181 however, the e.e.o.c. 179. ross adkin, panic buying follows coronavirus across the globe, medical xpress (mar. 5, 2020), https://medicalxpress.com/news/2020-03-panic-coronavirus-globe.html [https:// perma.cc/93w8-vwbj]. cf. janni leung et al., anxiety and panic buying behaviour during covid-19 pandemic—a qualitative analysis of toilet paper hoarding contents on twitter, 18 int’l j. env’t res. & pub. health 1 (2021) (analyzing the impact of social media on panic buying). 180. see generally jacobson v. commonwealth of mass., 197 u.s. 11, 27 (1905). 181. requiring an employee to provide proof of vaccination would be considered a medical inquiry and potentially violate the ada, unless the employer could show the inquiry is “job-related and consistent with business necessity.” 42 u.s.c. § 12112(d)(4). the standard to determine the inquiry will differ depending on whether it is for a current, prospective, or other employee. see id. at (d). the “final dose” will be different for each vaccine. paid time off is likely only needed for vaccines with harsher side effects such as the sars-cov-2 vaccine. 246 indiana health law review [vol. 19:217 requires that these incentives not be “so substantial as to be coercive.”182 while offering free vaccines, vaccine education, and on-site administration should be used whether manufactures implement a vaccine mandate or not, incentives may be too costly in the long run. furthermore, it may be necessary to implement a mandatory vaccine policy where persuasion efforts do not lead to high levels of vaccination among employees. even more concerning, some manufactures may be forced to implement some type of mandate due to an increasing number of lawsuits alleging osha-related violations and workers’ compensation claims.183 to help counteract this, many states have already enacted protections for employers providing some level of immunity from lawsuits involving employees alleging they were exposed to sars-cov-2 while acting within the scope of their employment.184 additionally, if a vaccine mandate is implemented, other practical considerations, such as the staggering of employee vaccinations, must also be examined. employers should also consider other eeo laws when implementing such a mandate. 182. what you should know about covid-19 and the ada, the rehabilitation act, and other eeo laws, u.s. equal emp. opportunity comm’n., https://www.eeoc.gov/wysk/what-yoush ou ld-kn ow -abou t -cov id-1 9 -a n d -a da-reh ab il i t a t ion -ac t -an d-o th e r -eeo-law s [https://perma.cc/r2ye-hj4r] (last visited july 22, 2021). this guidance is specifically related to the ada. see id. the guidance also only applies to employers who require proof of vaccination. id. the incentive limitation does not apply to employers who offer incentives to employees who voluntarily provide proof of vaccination so long as those who administered the vaccine to the employee were not the employer or the employer’s agent. id. 183. but see paul davidson & nicholas wu, workers face ‘uphill battle’ proving firms liable if they catch covid-19 as economy reopens, usa today (apr. 28, 2020, 3:54 pm), https://www.usatoday.com/story/money/2020/04/28/ coronavirus-can-you-sue-if-you-get-covid-19work/3035422001/ [https://perma.cc/yp4y-ytf7]; see also mark h. hyman et al., evaluating covid-19 injury claims with a focus on workers’ compensation, 62 j. occupational and env’t med. 692, 692-95 (2020) (noting it may be difficult to classify covid-19 as an occupational illness but that some states have provided broader protections for certain industries). cf. protecting workers: guidance on mitigating and preventing the spread of covid-19 in the workplace, u.s. dep’t lab., https://www.osha.gov/coronavirus/safework [https://perma.cc/ank3fvxs] (last visited feb. 8, 2021) (providing guidance to help limit the spread of sars-cov-2 within the workplace). president biden has directed osha to write a rule requiring employers with 100 or more employees to mandate employees get vaccinated or undergo weekly testing. path out of the pandemic: president biden’s covid-19 action plan, white house, https://www. whitehouse.gov/covidplan/ [https://perma.cc/5e2x-sul3] (last visited sept. 9, 2021) (the constitutionality of the president’s proposed ohsa rule is still unknown). cf. mark a. rothstein et al., employer-mandated vaccination for covid-19, 111 am. j. pub. health 1061, 1063 (2021) (providing potential legal arguments against an osha vaccine mandate). analysis into osha and workers’ compensation claims goes beyond the scope of this note. 184. accord ind. code § 34-30-32 et seq. (2021) (providing employers immunity from tort liability in certain actions dealing with sars-cov-2). governor eric holcomb signed this bill into law on february 18, 2021. the bill is retroactive to march 1, 2020, and is extended until december 31, 2024. id. these state actions do not protect employers against osha-related violations. 2022] the syringe that drips money 247 all of this is premised on whether the specific vaccine is approved by the fda or only authorized through eua. as previously stated, the eua statute does not explicitly discuss employers.185 thus, a plain reading of the statute could indicate employers may mandate vaccines under eua if they continue to follow title vii and other eeo laws. nonetheless, if the vaccine is only authorized through eua, an employer should consider delaying their vaccine mandate. finally, and perhaps most important, the manufacturing community, and employers at-large, should reach out to religious communities and explain the importance of vaccines. some may throw this proposition out as ludicrous and better suited for the healthcare industry; however, industries should work together to achieve common goals. nevertheless, these criticisms may be correct, as it would be a lofty and uncomfortable step for private employers to take, but it could make a world of difference. religion, no matter the denomination, is founded on principles that stress coming together for a better purpose and to better a community. therefore, showing a religious community the detrimental impact of a vpd spreading through a single manufacturing plant, let alone an entire community, could make an impact. of course, there is no legal obligation to take this step, but it is a low-cost act that could help persuade hesitant employees. vi. conclusion title vii’s fact-sensitive nature prohibits a conclusory statement that all manufacturing employers can implement a vaccine mandate and subsequently show an undue hardship whenever an employee seeks a religious accommodation. nevertheless, because of the enormous costs, inefficiencies, and safety hazards associated with a vpd spreading through the assembly line, many manufactures should be able to show allowing employees to remain unvaccinated against certain vpds would create greater than a de minimis cost. therefore, with guaranteed exceptions, title vii is unlikely to legally impede a manufacturer from implementing a mandatory vaccine policy for vpds that are reasonably likely to spread among employees while acting within the scope of employment. 185. see 21 u.s.c. § 360bbb-3. reverse payment: a comparative study garry a. gabison* and zaakir tameez** abstract this article compares reverse payment settlements, also known as pay-fordelay deals, in the united states and europe. these deals occur where a branded drug manufacturer sues, settles with, and pays a generic manufacturer to delay the entry of its generic. unlike the united states, which has a decentralized drug purchasing system, european healthcare systems such as those in france and the united kingdom wield monopsony buying power over drugs. we investigate whether regulator and monopsony power can neutralize these anticompetitive agreements. we conclude that while the incentives to agree to a reverse settlement are more limited in europe, they do not disappear. regulators should do more to encourage the entry of generics by: (1) making patents protected by anticompetitive reserve settlement unenforceable and (2) linking generic entry to a clear statutory entry system instead of an opaque patent system. i. introduction most pharmaceutical companies in both the united states (“us”) and the european union (“eu”) face little competition for their drugs because of patent and statutory protections. first, both us and eu regulators delegate to the pharmaceutical companies the task of assessing whether patents constitute entry barriers. in the us, the federal drug administration (“fda”) requires brand-name drug manufacturers to declare which patents cover a drug in its market authorization application. but the fda does not scrutinize these patent declarations. instead, the fda relies on generic manufacturers to challenge the patents or assert that patents are invalid and/or not infringed if they want to produce the same drug.1 in the eu, the european medicines agency (“ema”) ignores patent statuses * j.d.-ph.d., senior lecturer of law, economics & regulation at the centre for commercial law studies, queen mary university of london. ** l.l.m. candidate at the centre for commercial law studies, queen mary university of london. 1. 21 u.s.c. § 355(b)(2)(a). “(2) an application [. . .] shall also include [. . .] (a) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c)— (i) that such patent information has not been filed, (ii) that such patent has expired, (iii) of the date on which such patent will expire, or (iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and [. . .].” 22 indiana health law review [vol. 19:21 for the issuance of market authorization.2 most european countries – including france and the united kingdom (“uk”) – do not practice patent linkage.3 instead, generic manufacturers have to perform their own patent clearance studies to decide whether a generic drug infringes on brand-name patents.4 therefore, generic manufacturers must exercise more caution than in the us because they do not benefit from the market authorization disclosure. second, even without patent protection, pharmaceutical companies enjoy exclusivity periods in the us and eu. filing a market authorization guarantees a market exclusivity of five years in the us and ten years in the eu for most drugs.5 many manufacturers use different strategies to expend these exclusivity periods.6 the lack of competition has a larger effect on consumer surplus in drug markets than other markets. the demand curves for most medications are highly inelastic7 because they are necessities for most consumers. this inelasticity means that even a slight decrease in competition can lead to large price increase and deadweight loss. to countervail these effects, many countries regulate the price of medications. direct price regulation has proven difficult because costs are often difficult to assess.8 instead, many countries like france or the uk rely on the monopsony power of the healthcare system to negotiate prices against the costs 2. article 81 of regulation (ec) no 726/2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a european medicines agency and article 126 of directive 2001/83/ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use. 3. global guide to patent linkage, baker mckenzie (nov. 4, 2019), https://www. bakermckenzie.com/en/insight/publications/guides/global-gu ide-to-paten t-linkage [https://perma.cc/n237-u74t] (“patent linkage is generally understood to be the practice of linking the granting of marketing approval or any other regulatory approval for a generic or biosimilar medicinal product to the status of a patent for the originator reference product.”). 4. pharmaceutical sector inquiry final report, eur. comm'n ¶¶ 1100-04 (2009) [hereinafter ec report]. 5. valérie junod, droit pharmaceutique: un aperçu global, 4 eur. l.j. 23, 26 (2006). some medications, such as drugs for rare diseases (orphan drugs), have longer exclusivity periods in both the us and eu. see 21 u.s.c. § 360cc; article 8(1) of regulation (ec) no. 141/2000 of the european parliament. 6. see, e.g., ec report, supra note 4, at ¶ 1558 (identifying many strategies such as patent clusters around a medication, litigation against competitors, challenging market approvals, etc.). 7. see e.g., justin gatwood et al., price elasticity and medication use: cost sharing across multiple clinical conditions, 20 j. managed care pharmacy 1102 (2014). 8. see, e.g., patricia m. danzon, regulation of price and reimbursement for pharmaceuticals, oxford univ. press 286 (2012) (discussing the different regulatory approaches including cost of production pricing). 2022] reverse payment: a comparative study 23 of other existing treatments. monopsony power plays a central role9 in reducing prices of healthcare during negotiations between the purchasing governmental agency and the drug manufacturers. this negotiation approach has had some success.10 nonetheless, medication spending remains a substantial portion of total healthcare spending in france, the uk, and the us.11 competition authorities in the us and the eu have cracked down on some practices that enable drug manufacturers to extend their monopoly power and add to healthcare costs. this article focuses on one such practice: reverse payment settlements. it attempts to answer whether the centralized monopsony system common in the eu has decreased the incentives of drug manufacturers to carry out reverse payment settlements as compared to the us drug pricing system. section 2 focuses on drug pricing mechanisms in the us. these mechanisms remain opaque and do not provide many constraints on what drug manufacturers can charge. in this context, stopping competition becomes lucrative. courts have failed to provide plaintiffs with the tools that drug consumers need to increase competition and lower prices. section 3 discusses pricing strategies in the uk and france. drug manufacturers must negotiate with the agencies in charge of healthcare expenditure. these agencies wield a stronger bargaining position than private insurers in the us because of their monopsony power. however, reverse payments still occur, and the competition authorities still need to oversee drug settlements. section 4 provides some recommendations. first, the finding of an anticompetitive reverse payment should be coupled with a suspension of entry barrier—whether through compulsory licensing, rendering the patent unenforceable, or a price reduction of the branded drug. second, the market exclusivity period and the pricing mechanism of branded drugs should be linked to market authorization instead of patent protection. this approach would nullify the need to regulate pay-for-delay settlements and streamline generic entry. ii. reverse payments in the us this section highlights the complexity of the drug market in the us and the 9. see e.g., zack cooper et al., the price ain’t right? hospital prices and health spending on the privately insured, 134 q. j. econ. 51 (2019) (finding concentration of us insurers lead to lower prices in local markets). 10. pierre dubois & laura lasio, identifying industry margins with price constraints: structural estimation on pharmaceuticals, 108 am. econ. rev. 3685 (2018) (discussing how the switch in regulatory setting leads to a 2% price decrease for anti-ulcer drugs). 11. according to the organization for economic co-operation and development, medication expenditure constituted 13.03%, 12.27%, and 11.55% of total healthcare expenditure in france, the uk, and the us in 2018 respectively. medication expenditure includes over-the-counter and prescription drugs, but ignores drugs provided to patients “in hospitals and other health care settings.” pharmaceutical spending, org. econ. coop. & dev. 1 (2021), https://data.oecd.org/ healthres/pharmaceutical-spending.htm [https://perma.cc/nmp8-5jxv]. 24 indiana health law review [vol. 19:21 distorted incentives of market participants. case law shows that many pharmaceutical companies have delayed generic entry. the supreme court decision on the topic has left much to interpretation. public and private enforcers have faced problems proving payment amounts to pay-for-delay. a. opaque drug pricing: opportunities for pay-for-delay the us drug supply chain has been described as a “complex,”12 “nonintuitive,”13 and “gordian”14 system that is growing “curiouser and curiouser.”15 a traditional supply chain has manufacturers, wholesalers, and retailers distributing products and negotiating prices. but the us pharmaceutical industry has two parallel chains that distribute and negotiate separately. figure 1 is a simplified model of the distributing and pricing chains. the distribution chain runs from drug manufacturers, which sell products to wholesalers, which distribute them to retailers (pharmacies), which sell to consumers.16 each participant in the distribution chain buys and sells drugs at close to list price. however, list price is misleading. a parallel pricing chain negotiates (usually in secret) rebates and other discounts.17 thus, no public data exists on how much manufacturers receive for their drugs in the us.18 12. the prescription drug landscape, explored, pew trusts (mar. 8, 2019), https://www. pewtrusts.org/en/research-and-analysis/reports/2019/03/08/the-prescription-drug-landscapeexplored [https://perma.cc/xc7z-93yk]. 13. see gary novack, what determines how much your patient pays for their medication in the united states?, 167 am. j. ophthalmology 48 (2016). 14. see national academies of sciences, engineering, and medicine, making medicines affordable: a national imperative (2018) [hereinafter “national academies”]. 15. wayne winegarden, the economist costs of pharmacy benefit managers: a review of the literature, pac. rsch. inst. 1, 3 (2017). 16. national academies, supra note 14, at 41-47. 17. id. 18. id. 2022] reverse payment: a comparative study 25 insurance companies sit at the bottom of the pricing chain. insurance covered about 86% of drug spending in the united states in 2016.19 the largest payors are private insurance (43%) followed by medicare (29%) and medicaid (10%).20 medicare is a federal program that primarily supports the elderly and disabled. in theory, the federal government has significant buying power to negotiate rates and determine which drugs to cover. however, federal law prohibits the government from negotiating rates for most medicare drugs.21 the law also limits the ability of the government to use benchmarks, such as costeffectiveness, to decide which drugs to cover.22 so, medicare’s prescription drug program covers nearly all drugs that are approved by the fda.23 19. centers for medicare and medicaid services, national health expenditure projections 2017-2026, table 11 prescription drug expenditures; aggregate and per capita amounts, percent distribution and annual percent change by source of funds (feb. 16, 2018) (on file with the author). 20. id. 21. section 1860d-11(i) of the social security act, 42 u.s.c. § 1395w-111(i). 22. for a good discussion of the many relevant statutes, see national academies, supra note 14, at 49. 23. id. (“historically, cms and its predecessor organizations have relied on approval by the fda for those determinations, and have not used cost as a component of coverage 26 indiana health law review [vol. 19:21 medicaid is a federally financed program run by states that primarily covers the poor. medicaid has rebates set by law that ensure states receive rates at lower costs than either medicare or private insurers.24 these rates are pegged to either a fraction of the average manufacturer price or the best price that a manufacturer charges wholesalers.25 while regulating medicaid prices ensures that states pay less, it also disincentivizes manufacturers to compete. manufacturers that compete by lowering rates for other insurers risk reducing the prices used to calculate medicaid rates. most medicare and medicaid plans, while publicly funded, are administered by private insurance companies. these private insurers can negotiate rates directly with drug manufacturers. however, they usually opt not to because of their weak bargaining power. the insurance market is decentralized. in 2016, the share of the largest five insurance companies was 39.4% based on market capitalization; the share of the next twenty was only 33%.26 the rest of the market is covered by around 700 additional insurance companies.27 to make up for their limited buying power, insurers enlist pharmaceutical benefits managers (“pbms”).28 pbms are third-party administrators of prescription drug plans and formularies. they use their market power to negotiate drug rates with pharmacies and rebates with manufacturers on behalf of insurers. to do so, they often manage tiered formularies for insurance plans. in a tiered formulary, drugs that are assigned to higher tiers have higher copayments for patients. pbms use tier placement as a bargaining chip to reduce rates and increase rates. these negotiations typically occur in secret. pbms could use their bargaining power to reduce drug costs for consumers; they have however mixed incentives. unlike insurance, the pbm market is highly concentrated. the three largest pbms negotiate rates and rebates for nearly 75% of the drug purchasing market.29 pbms not only have market power against manufacturers, but also against insurers. these insurers are not privy to the confidential rates and rebates that pbms negotiate.30 so, a pbm could encourage manufacturers to increase public list prices while decreasing private rebates and pocket the difference.31 then, manufacturers can use these higher list prices as the baseline for determining rebates for medicaid plans and leverage determinations.”). 24. for a good discussion of the many relevant statutes, see id. at 107-08. 25. id. 26. see mitchell k. ng et al., u.s. healthcare insurance market concentration from 2001 to 2016: increased growth in direct written premiums and overall decreased market consolidation, 12 cureus 1 (2020). 27. id. 28. see generally, national academies, supra note 14, at 47-53. 29. pharmacy benefit managers: as drug prices soar, policymakers take aim, colo. health inst. 1, 5 (2018). 30. id. 31. id. because rebates are generally negotiated in secret, while list prices are often public, pbms can theoretically pocket the rebate savings and charge insurers prices close to the list price. 2022] reverse payment: a comparative study 27 these prices to negotiate rates for other insurers and out-of-pocket payors that lack buying power. in conclusion, no major payor of pharmaceuticals in the us has both significant buying power and the incentive to lower effective prices. this distorted pricing model contributes to significantly higher prices for brand-name drugs compared to other countries. for example, a 2021 study by the government accountability office determined that gross retail drug prices are 4.36 times higher in the us compared to france.32 another study estimates that retail drug prices are 2.56 times higher in the us compared to all oecd countries.33 b. pay-for-delay tests the gap between brand-name and generic prices is also much higher in the us than in other countries. one study estimates that the average annual retail price of therapy for brand-name drugs is eighteen times higher than that of generics.34 another study concludes that brand-name drugs are more expensive, while generics are less expensive, in the us than in other oecd countries.35 generic drugs save patients money while giving them a nearly identical drug to the brand-name medication. nearly every state in the us permits pharmacies to substitute brand-name drugs with generic drugs.36 some states require patient consent before pharmacists make substitutions, while other states require pharmacists to substitute in nearly all cases.37 brand manufacturers a strong incentive to delay the entry of cheaper, substitutable generic drugs. brand manufacturers can do so by suing generics alleging patent infringement—even when infringement was unlikely to have occurred. then, the brand offers to settle with the generic for the lawsuit it initiated. in these reverse payment settlement schemes, brand companies often pay generics hundreds of millions of dollars to not enter the market. the cartel schemes draw antitrust scrutiny because the parties are sharing monopoly profits rather than competing. they are also known as pay-for-delay agreements. the us regulatory framework incentivizes patent litigation that can lead to pay-for-delay settlements. passed in 1984, the hatch-waxman act offers generic companies an expedited approval process if they can show their generic is 32. prescription drugs: u.s. prices for selected brand drugs were higher on average than prices in australia, canada, and france, u.s. gov’t accountability office 1, 15 (2021). 33. andrew w. mulcahy et al., international prescription drug price comparisons: current empirical estimates and comparisons with previous studies, rand corp. 1, 12 (2021). 34. see stephen w. schondelmeyer & leigh purvis, price decreases for widely used generic drugs slow in 2017 after two years of substantial price drops, aarp pub. pol’y inst. 1 (2019). 35. mulcahy, et al., supra note 33, at xii. 36. see yan song & douglas barthold, the effects of state-level pharmacist regulations on generic substitution of prescription drugs, 27 health econ. 1717 (2018). 37. id. 28 indiana health law review [vol. 19:21 chemically similar to the brand-name drug and does not violate any brand-name patents.38 it encourages generic companies to more quickly introduce generics for drugs protected by weak patents. however, brand-name companies can delay the approval process for up to thirty months by timely filing a lawsuit against the generic alleging patent infringement.39 thus, brand-name manufacturers were incentivized to sue generic entrants irrespective of patent strength to delay the review process. as one court put it, “litigiousness was a product of hatchwaxman.’’40 reverse payment settlements that resolved patent infringement litigation thus became ubiquitous. in 2003, congress responded by passing a law41 that required pharmaceutical companies to report these settlements to the federal trade commission (“ftc”).42 the ftc would then investigate these settlements, challenge some in court, and publish annual reports that summarize the agreements formed each year.43 the ftc argued that these agreements violated section 1 of the sherman act by foreclosing competition between generic and brand-name drugs.44 circuit courts agreed that manufacturers who engaged in reverse payment settlements were maintaining monopolies over their brand-name drugs.45 but some circuits held that these monopolies are lawful because they are granted by patents. in schering-plough v. ftc, the eleventh circuit adopted a patent validity test.46 this test holds that a “reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the 38. drug price competition and patent term restoration act of 1984, 21 u.s.c. §§ 301, 355, 360cc. 39. 21 u.s.c. § 355(c)(3)(c). 40. in re wellbutrin xl antitrust litigation, 868 f.3d 132, 158 (3d cir. 2017) (internal quotation marks and citations omitted). 41. medicare prescription drug, improvement, and modernization act of 2003, h.r. 1, 108th cong. (2003). 42. 21 u.s.c. §§ 1112-13 (2011). 43. pharmaceutical agreement filings, fed. trade comm’n, https://www.ftc.gov/tipsadvice/competition-guidance/industry-guidance/health-care/pharmaceutical-agreement-filings [https://perma.cc/9f2f-b26m] (last visited april 5, 2021). 44. id. 45. see generally andrx pharms., inc. v. biovail corp. int’l, 256 f.3d 799 (8th cir. 2001); louisiana wholesale drug co. v. hoechst marion roussel, inc. (in re cardizem cd antitrust litig.), 332 f.3d 896 (6th cir. 2003); valley drug co. v. geneva pharms., inc., 344 f.3d 1294 (11th cir. 2003); schering-plough corp. v. ftc, 402 f.3d 1056 (11th cir. 2005); joblove v. barr labs., inc. (in re tamoxifen citrate antitrust litig.), 466 f.3d 187 (2d cir. 2006); ark. carpenters health & welfare fund v. bayer ag (in re ciprofloxacin hydrochloride antitrust litig.), 544 f.3d 1323 (fed. cir. 2008); arkansas carpenters health & welfare fund v. bayer ag, 604 f.3d 98 (2d cir. 2010); in re k-dur antitrust litig., 686 f.3d 197 (3d cir. 2012); ftc v. watson pharms., inc., 677 f.3d 1298 (11th cir. 2012). 46. schering-plough corp., 402 f.3d at 1064. 2022] reverse payment: a comparative study 29 exclusionary potential of the patent.”47 because a valid patent grants a legal right to exclude, a brand manufacturer suing for patent infringement cannot be violating antitrust law. so, a pay-for-delay agreement could only be illegal if the patent was invalid.48 this created a significant hurdle for the ftc and private plaintiffs, who were expected to show a patent was invalid when its infringement lawsuit had already been settled. in k-dur antitrust litigation,49 the third circuit disagreed with the eleventh circuit in a case that concerned the same agreement as schering-plough. the court held that the manufacturer’s monopoly over its brand-name drug is only lawful if its patents are valid. because the parties settled out of court with a large payment, the court reasoned that the contested patents were probably weak.50 thus, the payment could reveal that the generic was likely to win the case if it did not settle. so, the court ruled that the reverse payment settlement violated antitrust law even though the underlying patent validity was unknown because it eliminated the possibility of competition.51 the supreme court followed a similar line of reasoning in ftc v. actavis, inc.52 the brand firm solvay sued the generic firm actavis for allegedly violating its patents in creating a generic alternative of the testosterone drug androgel.53 solvay than settled with actavis, agreeing to pay $19-30 million per year to delay generic entry.54 solvay sued and settled with other generic companies as well.55 in 2009, the ftc sued all parties, alleging illegal monopoly profit sharing.56 the appeals court ruled that the settlement scheme could not be illegal because solvay’s agreements fell within the scope of its patent rights.57 at the ftc’s request, the court granted certiorari. to evaluate whether a reverse payment scheme is anticompetitive, the court adopted an unjustified payment size test.58 in the court’s reasoning, a larger payment by the plaintiff suggests that the plaintiff did not expect to win the infringement case. payment size could serve as a proxy for patent validity. the question that courts must then resolve is whether the payment size is “large and 47. ftc v. actavis, inc., 133 s. ct. 2223, 2230 (2013) (citing ftc v. watson, 677 f.3d 1298, 1312 (11th cir. 2012)). 48. id. 49. in re k-dur antitrust litig., 686 f.3d at 211 (“we do not find the eleventh circuit’s decision in schering-plough persuasive, and thus decline to follow it.”). 50. id. 51. id. 52. actavis, inc., 570 u.s. at 136. 53. id. at 144-46. 54. id. 55. id. 56. id. 57. id. 58. id. at 159 (“the likelihood of a reverse payment bringing about anticompetitive effects depends upon its size.”) 30 indiana health law review [vol. 19:21 unjustified.”59 to do so, courts should look at “[the payment] size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing [procompetitive] justification.”60 actavis was a victory for consumers. it established that reverse payment schemes can be subject to antitrust scrutiny under an unjustifiability standard. since then, the number of illegal reverse payment schemes in the united states has reduced considerably (according to the ftc).61 but this does not mean that reverse payment schemes have disappeared. instead, pharmaceutical companies have established many creative arrangements that make prosecution harder.62 courts have also disarmed some public and private enforcers from disincentivizing pay-for-delay. first, some courts have constricted the ability of private plaintiffs to claim antitrust injury. in wellbutrin,63 a pay-for-delay scheme settled several patent disputes for a brand-name drug but left one dispute unresolved because the patent belonged to a third party.64 the court ruled that plaintiffs could not claim injury without showing that the outstanding patent dispute was likely to be resolved in favor of the generics.65 to make this showing, the court expected plaintiffs to discuss the underlying patent’s validity; it held that the unjustified payment size alone was insufficient evidence.66 in nexium, the first circuit similarly ruled that defendants did not cause injury even though they were liable.67 the companies astrazeneca and ranbaxy formed a billion-dollar reverse payment scheme. ranbaxy, however, was soon thereafter suspended from marketing any drugs by the fda after a quality control scandal.68 so, the court reasoned that generic entry by ranbaxy never would have 59. id. 60. id. 61. jamie towey & brad albert, then, now, and down the road: trends in pharmaceutical patent settlements after ftc v. actavis, fed. trade comm’n (may 28, 2019, 12:23 pm), https://www.ftc.gov/news-events/blogs/competition-matters/2019/05/then-now-down-road-trendspharmaceutical-patent [https://perma.cc/zq3x-6r7e]. 62. see garry a. gabison and zaakir tameez, multilateral reverse payment settlements, 16 rutgers bus. l. rev. 340 (2021). in recent years, brand and generic companies have formed complex pay-for-delay schemes involving multiple parties, drugs, or jurisdictions. 63. in re wellbutrin xl antitrust litigation, 868 f.3d 132, 141 (3d cir. 2017). 64. id. at 167. 65. id. 66. id. at 168 n.58 (“we cannot resolve this aspect of the case without considering the merits of the underlying patent dispute.”). 67. see am. sales co., llc v. astrazeneca lp (in re nexium (esomeprazole) antitrust litig.), 842 f.3d 34 (1st cir. 2016). 68. id. at 43. see also katherine eban, how ranbaxy hurtled towards a meltdown, mint, (july 11, 2019, 10:13 pm), https://www.livemint.com/companies/news/how-ranbaxy-hurtledtowards-a-meltdown-1562861830620.html [https://perma.cc/tt4e-ww37]. 2022] reverse payment: a comparative study 31 happened regardless of the illegal pay-for-delay scheme.69 the court denied plaintiffs any relief. second, other courts have undermined the ability of the government to disincentivize pay-for-delay. in ftc v. abbvie, inc.,70 the third circuit held that section 13 of the federal trade commission act does not grant the agency the authority to order disgorgement of the profits made from a reverse payment scheme.71 in the court’s view, the ftc can only enjoin antitrust defendants from committing future harm.72 this statutory interpretation was echoed by a unanimous supreme court in a recent ruling.73 finally, courts have only accepted federal antitrust damage claims from direct purchasers of brand-name drugs.74 while this approach is consistent with wellestablished supreme court doctrine,75 it is poorly suited for a market where direct purchasers have mixed incentives on reducing prices. direct purchasers are typically wholesalers but can also be pbms, pharmacies, or insurers.76 wholesalers purchase drugs from manufacturers and re-sell them to pharmacies to make profit on the margins.77 pharmacies pass on most costs to consumers and make profit on privately negotiated reimbursements from pbms. pbms pass on most costs to insurers and make profit on privately negotiated rebates with manufacturers. and insurers pass on most costs to consumers indirectly through insurance premiums.78 each of these participants in the pharmaceutical supply chain makes profit from private or nontransparent margins that are benchmarked to the public list prices set by manufacturers.79 these public list prices, therefore, are subject to distorted incentives. but the downstream implications are serious for consumers, who suffer the brunt of brand-name drug overcharges but lack federal standing in antitrust claims as indirect purchasers. while this issue does not have a clear resolution under standard antitrust doctrine, it highlights an additional challenge that plaintiffs face to disincentivize pay-for-delay in the united states. 69. id. 70. see ftc v. abbvie inc., 976 f.3d 327 (3d cir. 2020). 71. id. at 374-81. 72. id. 73. see amg cap. mgmt., llc v. ftc, 141 s.ct. 1341 (2021). 74. see, e.g., in re niaspan antitrust litigation, 42 f. supp. 3d 735 (2014); in re nexium antitrust litigation, 777 f.3d 9 (1st cir. 2015); in re aggrenox antitrust litigation, 94 f. supp. 3d 224 (2015); in re humira (adalimumab) antitrust litigation, 465 f. supp. 3d 811 (n.d. ill. 2020). 75. see illinois brick v. state of illinois, 431 u.s. 720 (1977). 76. for example, all of these classes were litigants in in re lipitor antitrust litigation, 868 f.3d 231 (3d cir. 2017). 77. national academies, supra note 14, at 41-47. 78. id. 79. neeraj sood et al., follow the money: the flow of funds in the pharmaceutical distribution system, usc schaeffer ctr. for health pol’y & econ., figure 2 (2017). 32 indiana health law review [vol. 19:21 iii. reverse payments in the eu this section investigates the importance of generics in europe and the need to decrease reverse payment settlement in europe – even though prices are controlled through a centralized health care system. a. monopsony decreases the incentive but does not eliminate pay-for-delay all european countries have socialized health care. the entities in charge of health care act as monopsonists. these monopsonists control prices and hence may decrease the incentive of pharmaceutical companies to attempt pay-fordelay. the first subsection below discusses the healthcare system in the uk and france. the second subsection discusses the need to enable generic competition. 1. the health care system in the uk and france in both the uk and france, the regulated prices of medication used to be derived through a cost-plus-profit margin model. both countries deviated from this model because of the difficulties in proving costs.80 in the uk, the national health service (“nhs”) is the main purchaser of medications. the national institute for health and care excellence (“nice”) measures the cost efficiency of a medication based on the offer made by the manufacturer.81 new drug manufacturers must show that the new drug “provides an economic advantage over the currently used next best treatment for the same condition.”82 if the treatment passes a certain cost-effectiveness threshold, nice recommends it for adoption.83 if the threshold is not passed, the manufacturer may negotiate with the nhs.84 generic entry undercuts brand-name drug profits in two ways. first, uk pharmacists can substitute a brand drug with a generic and pocket the difference.85 thus, they are incentivized to look for the cheapest generic86 and often benefit from the cheaper products.87 second, after generic entry, nice 80. see vivek kotecha & karl claxton, who decides the price and availability of nhs medicines?, ctr. for health & pub. int. 1 (2019). 81. see the pharmaceutical price regulation scheme 2014, u.k. dep’t health 1 (2013). 82. id. at ¶ 13. 83. changes to nice drug aappraisals: what you need to know, nat’l inst. for health & care excellence (apr. 4, 2017) https://www.nice.org.uk/news/feature/changes-to-nice-drugappraisals-what-you-need-to-know [https://perma.cc/j5vg-udse]. 84. see leo ewbank et al., the rising cost of medicines to the nhs: what’s the story?, king’s fund 1 (2018). 85. see the pharmaceutical price regulation scheme 2009, ass’n brit. pharm. indus. 1 (2008). 86. id. at 23. 87. panos kanavos et al., the economic impact of pharmaceutical parallel trade in european union member states: a stakeholder analysis, london sch. econ. & pol. sci. 1, 123 (2004). 2022] reverse payment: a comparative study 33 measures the cost-effectiveness of the generic alternative rather than the original brand-name drug. in france, the social security (securité sociale) reimburses the cost of medication. the system is financed through taxes on income and on alcohol and tobacco. according to the french pharmaceutical association, french pharmaceutical manufacturers earn over 80% of their income through sales to the social security system.88 the price of a medication depends on several factors.89 first, the manufacturer must decide whether it wants the product reimbursed. if the medication is not reimbursed, the manufacturer can set its wholesale price based on economic forces (i.e., competition, demand, etc.). pharmacists can also set their margin freely. this may lead to double marginalization, which means higher prices but lower demand. if a manufacturer decides to have its medication reimbursed, then the social security determines how the prices are fixed in accordance with the law.90 reimbursement will mean wider access and demand, but lower prices. the comité économique des produits de santé (“ceps”) negotiates the price with the manufacturer. the price will depend on four factors: (1) improvement on existing medication(s); (2) price of existing therapeutic treatment(s); (3) expected demand of the medication; and (4) actual use of the medication.91 depending on its therapeutic offering, the medication will be reimbursed at 0%, 35%, 65%, or 100% of the medication price while the rest is paid by the consumer (or their complementary insurance).92 the ceps will negotiate the price up or down from the price of existing treatment based on the improvement offered. once a generic enters, the price of the generic is fixed at 60% of the original negotiated price and the price of the brand is decreased by 20%.93 after 18 months, the branded medication is reimbursed based on the generic price or both 88. bilan économique, les enterprises du medicament 1, 6 (2020). the industry makes €60bn in france. 50% of this revenue is from exports. €25.5bn come reimbursement from insurances, which include both the social security system and private top-up insurances, who complement the social security for deductibles. 89. sophie rémond, the price of drugs, institut national de la consommation (sept. 12, 2020) https://www.inc-conso.fr/content/le-prix-des-medicaments [https://perma.cc/m854yv9l]. 90. l’article l. 162-16-4 du code de la sécurité sociale. 91. id. (“la fixation de ce prix tient compte principalement de l'amélioration du service médical rendu par le médicament, le cas échéant des résultats de l'évaluation médico-économique, des prix des médicaments à même visée thérapeutique, des volumes de vente prévus ou constatés ainsi que des conditions prévisibles et réelles d'utilisation du médicament.”) 92. rémond, supra note 89. the price will also depend on comparable european country. the reimbursement system was introduced because france was the highest consuming country in the world. see also sylvain duffaud & sandra liébart, how do general practitioners limit their prescriptions? qualitative study by collective interviews, 26 santé publique 323 (2014). 93. rémond, supra note 89. 34 indiana health law review [vol. 19:21 prices are further dropped.94 for reimbursed medication, the margins of pharmacists are also regulated: on average, 76% of the medication price is pocketed by the manufacturer, while the pharmacists and wholesalers make 22% combined and the remaining 2% is the tax.95 the monopsony power of the uk and french governments allows them to negotiate prices lower than us insurers.96 however, monopsony power does not eliminate the need for generics. the next section investigates drug competition in countries with drug price regulations. 2. intra-brand vs. inter-brand competition: the eu functioning and drug circulation in the eu competition plays an important role in decreasing prices. in any country, competition comes from: (1) the same drug coming from abroad through parallel imports (intra-brand competition); (2) different drugs with similar therapeutical treatment (“me-too” drugs); and (3) generics competition (inter-brand competition). of these three, only generic competition exerts significant downward pressure on drug prices. first, intra-brand competition occurs when a branded drug competes with itself. in europe, a branded drug may compete with itself through parallel imports. parallel imports occur when a branded drug marketed for one country is sold in another country. aside from the coronavirus pandemic (when the european commission intervened),97 each member state individually negotiates with pharmaceutical companies.98 these individual negotiations lead to different prices in different jurisdictions. parallel importers can take advantage of those different prices to profit.99 parallel imports rely on the patent exhaustion doctrine: once a patent holder sells a patented product, the product can circulate freely inside the stream of commerce. in the european economic area (“eea”), the patent exhaustion doctrine applies to all patented products within the stream of commerce – even though patent protection remains member state-specific.100 in the post-brexit united kingdom, parallel imports are accepted from the eea, but not vice94. id. 95. id. 96. prescription drugs, supra note 32. 97. see commission decision of june 18, 2020, eur. comm’n 1 (2020) (approving the agreement with member states on procuring covid-19 vaccines on behalf of the member states and related procedures); annex to the commission decision, eur. comm’n 1 (2020). 98. nicole scholz, medicinal products in the european union, eur. parliamentary rsch. serv. 9 (2015). 99. kanavos et al., supra note 87, table 6.20 (showing parallel importers are the main beneficiary of this practice). 100. garry a. gabison, worldwide frand licensing standard, 8 am. u. bus. l. rev. 139, 154-62 (2019). 2022] reverse payment: a comparative study 35 versa.101 in centrafarm bv et adriaan de peijper v. sterling drug inc.,102 sterling drug inc. sought an injunction to stop the dutch drug seller centrafarm from importing sterling-patented drugs from germany and england to sell in the netherlands.103 the dutch court referred the case to the european court of justice. the court concluded that the right of a patentee “to prohibit the sale . . . is incompatible with the rules of the eec treaty concerning the free movement of goods within the common market.”104 the court also allowed parallel imports from a member state where the patent holder freely marketed the drug but did not hold a patent105 into a member state where it did. more importantly, the court also barred laws that impede the movement of generics between european countries.106 however, the court held that if the drug was manufactured in one country under a compulsory license, the patent holder may prevent import to another european country where it holds another patent.107 parallel imports enabled some arbitrage. prices decrease in countries where drugs are more expensive108 and the national insurance system garner some benefits.109 however, these benefits are limited. regulated prices deter pharmaceutical manufacturers from introducing their own generics, which would create undesired intra-brand competition. parallel imports increase this 101. exhaustion of ip rights and parallel trade, uk i.p. off., https://www.gov.uk/ guidance/exhaustion-of-ip-rights-and-parallel-trade (last updated june 21, 2021). 102. centrafarm bv and adriaan de peijper v. sterling drug inc, case 15-74 (1974). 103. centrafarm b.v. and adriaan de peijper v sterling drug inc., [1974] 2 c.m.l.r. 1. 104. case 15-74 at ¶ 15. 105. see e.g., merck & co. inc. v. stephar bv, case 187/80 (1980) (allowing the free movement of a drug from a country where the patent holder marketed the drug but did not have a patent to a county where it holds a patent); merck & co. inc. v primecrown ltd., case 267/95 (1997) (allowing the free movement of a drug from a country where the patent holder marketed the drug but did not have a patent because pharmaceutical were not patentable to a county where it holds a patent). 106. kohlpharma gmbh v. bundesrepublik deutschland, case c-112/02 (2004) (barring laws that affect the free movement of a drugs even when the parallel importer did not obtain marketing authorization when it has the same active ingredients as another authorized drug – even if the drug does not originate from the same entity); delfarma sp. z o.o. v. prezes urzêdu rejestracji produktów leczniczych, wyrobów medycznych i produktów biobójczych, case c-387/18 (2019) (barring laws that affect the free movement of a generics even if the parallel importer did not obtain a marketing authorization when it has the same active ingredients as an authorized patented drug). 107. pharmon bv v. hoechst ag, case 19/84 (1984) (allowing the patent holder to block the importation of patented drugs that were produced under a compulsory because he did not freely choose to market the drug). 108. see e.g., mattias ganslandt & keith e. maskus, parallel imports and the pricing of pharmaceutical products: evidence from the european union, 23 j. health econ. 1035 (2004) (finding parallel imports lead to a price decrease in sweden). 109. kanavos et al., supra note 87, table 6.16. 36 indiana health law review [vol. 19:21 deterrence because introducing a generic could affect all other countries in the european common market. parallel imports have also incentivized drugs companies to negotiate higher prices in countries where prices were previously lower. these low-price countries have had to react and change their laws to account for parallel exports.110 this reaction explains why the french ceps looks at the prices set in the uk, germany, italy, and spain when negotiating its prices with pharmaceutical companies.111 the limited success of parallel import at creating competition means that competition must either come from a drug with a similar therapeutic treatment or from a generic. drugs with similar therapeutic treatment are known as “me-too” drugs. these me-too drugs have not created the desired competition.112 this limited competition has been linked to the pricing mechanisms in countries with large monopsonist health insurance.113 for example, the french system creates no incentive for me-too drugs to compete on price: doctors prescribe the drug based on treatment, not on cost. the doctor has no incentive to look at treatment cost when prescribing drugs.114 the decisionmaker in the market for drug consumption is the doctor, whereas the payors are the health agency and consumers (through deductibles). this relationship raises a principal-agent problem because the decisionmaker differs from the cost bearer.115 thus, generics remain the only mechanism for competition in the 110. id. at table 4.3. 111. see rémond, supra note 89 (« ce prix dépend : . . . des prix pratiqués à l’étranger : le ceps est soumis au "comparateur de prix européen" qui est une disposition par laquelle il s’oblige à fixer un prix similaire à ceux pratiquées au royaume-uni, en allemagne, en italie et en espagne. le prix du médicament ne peut être inférieur aux prix pratiqués dans ces quatre pays. » which translates to “the price depends on the prices practiced abroad: the ceps must “compares with other european prices” which obliges the ceps to fix a similar price to those practices in the uk, germany, italy, and spain. the price of medication cannot be inferior to the price practices in those four countries.”). 112. see e.g., gisela hostenkamp, do follow-on therapeutic substitutes induce price competition between hospital medicines? evidence from the danish hospital sector, 111 health pol’y 68 (2013) (finding limited evidence of price decreased linked to the introduction of competing therapeutic treatment). 113. see mats ekelund & björn persson, pharmaceutical pricing in a regulated market, 85 rev. econ. & stat. 298 (2003) (comparing the us to sweden in their pricing, finding that, in sweden, price less competition occurs when new therapeutic drugs were introduced when controlling to therapeutic improvements, and concluding that the price-cap system has led to less declining prices over time). 114. duffaud & liébart, supra note 92, at ¶ 41 & ¶ 47 (surveying french doctors and they observed that doctors did not consider the price or the reimbursement rate when making prescriptions). 115. see e.g., oliver d. hart & bengt hölmstrom, the theory of contracts, advances econ. theory: fifth world cong. 75-106 (t. bewley ed. 1987). 2022] reverse payment: a comparative study 37 pharmaceutical industry when health systems implement a regulated pricing mechanism. therefore, health agencies in those countries should pay more attention to any barriers to generic entry because these barriers can cost taxpayers billions of pounds or euros. brand-name drug manufacturers in the uk and france have a strong incentive to cartelize with generic entrants because of the pricing mechanism. as discussed, uk generic manufacturers set their own prices, compete directly with brand-name drugs, and lower the cost-effectiveness benchmark for alternative branded drugs. this combination has the potential to destroy the monopoly profits of a brand-name drug. and in france, branded drugs lose 20% of the price of the medication immediately upon generic entry and 60% of the price after eighteen months.116 this price decrease does not even account for the substitution effect linked to consumers buying from the generic company instead of the branded manufacturer. the margins in the uk and france are still smaller than in the us, where pay-fordelay is more common.117 but this does not negate the incentive for european drug manufacturers to introduce barriers to entry. the next section discusses european cases of pay-for-delay. b. the “no-alternative-explanation” test the european commission (“commission”) has fined a few companies over the years for “pay-for-delay” agreements. however, cases are far and few by comparison with the number of cases in the us. on june 19, 2013, the commission fined a brand manufacturer, lundbeck, and four generic manufacturers—generics (uk) (a merck subsidiary), arrow, alpharma, and ranbaxy—for six agreements spanning across different countries within the european economic area.118 the commission found that the agreements did not resolve any patent disputes and delayed generic market entry beyond what the patent protection would have allowed: the brand manufacturer paid the generic companies lump sums and bought their drug stocks to destroy them.119 the participants appealed the commission’s decisions.120 in 2016, a general court of the european union found that the agreements had for object a restriction of competition and that the brand manufacturer failed to demonstrate 116. rémond, supra note 89. 117. comparaison internationale des prix des medicaments, ministère des solidarités et de la santé 1 (2015). 118. case at.39226 – lundbeck (2013). 119. id. 120. see case t-460/13 sun pharmaceutical indus. & ranbaxy v. comm’n; t467/13 arrow grp. & arrow generics v. comm’n; t-469/13 generics (uk) v comm’n; t-470/13 merck v. comm’n; t-471/13 xellia pharmaceuticals & alpharma v. comm’n; t-472/13 lundbeck v. comm’n. 38 indiana health law review [vol. 19:21 that the agreements were necessary to protect its intellectual property rights.121 because of the anticompetitive object of the agreement, the commission did not have to investigate the effect of the agreement.122 the general court affirmed the €150 million fines. the general court spent a large part of the decision assessing whether generic manufacturers were competitors.123 it looked at whether the companies believed that the generic had the ability to enter the market.124 the court reasoned that the fact that brand manufacturer concluded these “agreements with the generic undertakings is a strong indication that it perceived those undertakings as a potential threat.”125 the general court also rejected the scope-of-the-patent test, citing actavis.126 in 2013, the commission fined the brand manufacturer, janssen-cilag (a johnson & johnson subsidiary), and the generic manufacturer, sandoz (a novartis subsidiary), for pay-for-delay in the netherlands.127 the “co-promotion” agreement set out profit transfer to sandoz in exchange for promoting the branded product and refraining from introducing its own generic. this agreement delayed entry from july 2005 to december 2006. the parties did not appeal the €16 million fines. in 2014, the commission fined a brand manufacturer, servier, and five generic manufacturers (niche/unichem, matrix (a mylan subsidiary), teva, krka and lupin) €427.7 million for multiple deals delaying the entry of generics.128 servier deployed different strategies (including catch-and-kill129 of compound manufacturers) to maintain its monopoly. on appeal, the general court affirmed the commission’s decision with respect to four of the five generics based on the object of the agreements.130 it confirmed the amount of servier’s fine with respect to three agreements and reduced it with respect to the fourth agreement (with matrix). the general court focused on the commission’s findings to conclude that the agreement had an anticompetitive object. the court stated that the commission 121. case t-472/13 at ¶¶ 478-501 (“in that respect, even if the agreements at issue also contained restrictions potentially falling within the scope of the applicants’ patents, those agreements went beyond the specific subject matter of their intellectual property rights, which indeed included the right to oppose infringements, but not the right to conclude agreements by which actual or potential competitors were paid not to enter the market.”). 122. id. at ¶¶ 418-40. 123. id. at ¶¶ 88-330. 124. id. at ¶ 131. 125. id. at ¶ 181. 126. id. at ¶¶ 353, 492-93 (citing actavis to support its rejection of the patent scope test). 127. case at.39685 – fentanyl. 128. case at.39612 – perindopril (servier) 129. catch-and-kill or “killer acquisitions” refers to purchasing and shutting down a competitor before they can start marketing the product. see e.g., colleen cunningham et al., killer acquisitions, 3 j. pol. econ. 129, 649-702 (2021). 130. case t-691/14. 2022] reverse payment: a comparative study 39 rightly considered (1) “transfer of value from the originator company to the generic company”; (2) whether the parties were “potential competitors”; (3) “whether those settlements included non-challenge and non-marketing clauses”; and (4) whether the parties signed to these non-marketing and non-challenge clauses “in return for a transfer of value.”131 the general court also focused on the existence of “side deals” that can be used to induce the parties to sign onto those agreements.132 the court acknowledged that the commission would struggle making connections between side deals unless they are “concluded on the same day, where they are legally linked, the binding nature of one of the agreements being conditional upon the conclusion of the other agreement, or . . . they are indissociable.”133 the general court spent a lot of time on appeal establishing the market definition and discussing whether the non-identical generics compete with the branded products. the former question focused on treatment;134 but the court found that me-too drugs “exercised little pressure on the prices of” the patented drug.135 in the latter inquiry, the court found medications – generics included – with the same active ingredients may be considered competitors.136 these cases show that the commission has taken an active role in enforcing pay-for-delay. despite these cases, in many situations, pay-for-delays do not have a european dimension that would require the commission’s involvement. for example, in the generics (uk) ltd et al. v. competition and markets authority137 case, the uk competition authority intervened in a case involving uk sales.138 in this case, the patent holder, glaxosmithkline plc (gsk), concluded multiple agreements with generic manufacturers who had submitted or obtained market authorization139 applications in different european countries: ivax in ireland; guk in denmark; and alpharma in the uk. the generic manufacturers agreed to stop ongoing challenges to gsk’s patent in exchange for exclusive dealing agreements. the uk competition and markets authority fined these companies for 131. id. at ¶ 406 and affirmed by the general court in ¶ 418. 132. id. at ¶ 797. 133. id. at ¶ 798. 134. id. at ¶¶ 123-40. 135. id. at ¶ 125. 136. id. at ¶ 131. 137. generics (uk) ltd., glaxosmithkline plc, xellia pharmaceuticals aps, alpharma llc, formerly zoetis products llc, actavis uk ltd., merck kgaa v. competition & markets authority, case c-307/18 (2020). 138. note that this case was expedited because of the uk’s exit from the eu. 139. drug manufacturers must seek a market authorization from “the competent authorities of that member state . . . in accordance with regulation” to commercialize a drug in the eu. id. ¶ 40. mas ensure the protection of patients and public health. id. ¶ 139. patents are jurisdictional in the eu: with such authorization, the manufacturer can sell across eu borders as long as the drug does not infringe any patents. 40 indiana health law review [vol. 19:21 forming a cartel (unlawful agreements and concerted practices) and gsk for abusing its dominant position. the parties appealed the decision to the competition appeal tribunal who referred some questions to the general court of the european union. first, the appeal tribunal asked: “for the purpose of article 101(1) [tfeu], are the holder of a patent for a pharmaceutical drug and a generic company seeking to enter the market with a generic version of the drug to be regarded as potential competitors when the parties are in bona fide dispute as to whether the patent is valid and/or the generic product infringes the patent?”140 the uk appeal tribunal added further sub-questions to the general court of the european union. first, it asked whether ongoing litigations would impact the anticompetitive ruling. if it did, the tribunal asked whether the probability of invalidation/success, or the duration of delay versus the duration of patent validity, would affect the anticompetitive finding. the european court of justice refers to this as the “effect” of the agreement.141 second, it asked whether the benefit or payment size would affect this finding as compared to: (1) the litigation costs; and (2) the potential market earnings if the patent is invalidated. the european court of justice refers to this as the “object” of the agreement.142 these questions mirror the inquiry that took place in us courts. the general court found that reverse payment can amount to a violation of the competition laws. however, the general court went further. first, the general court stated that courts must still assess barriers to entry; but the lawsuits against the generic manufacturers can be used as evidence that the brand manufacturer sees the generic manufacturers as possible entrants.143 second, the general court stated that courts do not have to investigate the validity of the underlying patent.144 the agreement to limit trade was sufficient in itself to find anticompetitive object. third, the general court recognized that the agreements must be viewed in light of each other.145 because gsk concluded those three agreements, it could maintain its dominant position: together, they formed an overall multilateral reverse payment strategy. in many respects, the general court went further than the us supreme court and the federal circuit courts. the general court presented a “no-alternative 140. id. at ¶ 21. 141. id. 142. id. 143. id. at ¶ 52. 144. id. at ¶ 122. 145. id. at ¶ 155-57 (“[t]he set of settlement agreements concluded on the initiative of gsk were part of an overall strategy on the part of that manufacturer of originator medicines and had, if not as their object, at least the effect of delaying the market entry of generic medicines [. . .]. the anticompetitive effects of such a contract-oriented strategy are liable to exceed the anticompetitive effects inherent in the conclusion of each of the agreements that are part of it.”). 2022] reverse payment: a comparative study 41 explanation” test: if the agreement has the object of restricting entry, then it is anticompetitive. therefore, the court did not require looking at whether the agreement was effective at decreasing entry. however, if the competition authority tries to prove the agreement has anticompetitive effects, then the competition authority cannot presume that, without the agreement, the patent would have been invalidated or the parties could settle in a less restrictive manner. the patent holder could also present pro-competitive evidence. the next section discusses what can be done to further disincentivize pay-fordelay and ease the entry of generics. iv. recommendations and conclusion pay for delays are hard to identify and even harder to prosecute. this section attempts to make some recommendation how pay-for-delay can be disincentivized or illuminated. a. remedies against abuse current remedies are maladapted for pay-for-delay suits. they do not optimally compensate the victims of cartels, nor do they optimally deter the cartel members. in private suits, damages attempt to make the victims whole. in cartel suits, damages should compensate the purchasers of the good for the additional costs linked to the coordinated behavior. in the us, these damages are trebled to promote deterrence.146 however, in practice most total damages do not even fully compensate consumers once.147 even if they compensate for the price difference, compensatory damages do not cover the harm created by pharmaceutical companies carrying out pay-fordelay. victims in this case would include both the drug purchasers and the individuals who had not been able to purchase the drug because of the cartel surcharge.148 the latter victims cannot recover from the pain and suffering that would have been avoided had they had access to these medications. since pharmaceutical companies do not internalize these costs, they are not optimally deterred. in public suits, fines and declaratory judgements are also maladapted to deterring pay-for-delay cases for similar reasons. fines attempt to make the cartel members internalize the cost of their past activities. declaratory judgments invalidate agreements to stop the cartel from operating. however, these two remedies do not address the issues of future activities. in the case of pay-fordelay, the patents used to leverage a settlement remain in play. after the agreements are invalidated and the fines are paid, the branded companies would 146. 15 u.s.c. § 15(a). 147. see john m. connor & robert h. lande, not treble damages: cartel recoveries are mostly less than single damages, 100 iowa l. rev. 1997 (2014). 148. see e.g., blue shield of virginia v. mccready, 457 u.s. 465 (1982) (holding purchasers of alternative treatment had standing to recover damages). 42 indiana health law review [vol. 19:21 still return to a monopoly position. the period until which generics may enter still leads to more monopoly deadweight loss. to address the issue of future activities, courts and policymakers should impose three remedies. first, courts should create a compulsory licensing scheme. if a patent holder has been found to engage in an anticompetitive payfor-delay, then any generic manufacturer should be able to enter the market. most countries – including france, the uk, and the us – have compulsory licenses.149 compulsory licenses are rare occurrences because some argue that it would deter future innovations; however, the evidence tends to contradict this argument.150 under the agreement on trade-related aspects of intellectual property rights (“trips”),151 a government can create compulsory licenses for medications if the country faces a public health emergency.152 the trips agreements also permit these licenses to address “the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade.”153 the trips authors may not have contemplated pay-for-delay when drafting this article; but pay-for-delay is an unreasonable restraint of trade. compulsory licensing as a remedy for pay-for-delay would provide an additional deterrent. courts may disfavor this remedy because it requires ongoing monitoring to ensure the compulsory licensing fee is properly set and paid. however, this remedy would address future sales from the patent holder. second, since most courts do not like constant supervision, courts may delegate that regulatory duty.154 in most countries, governmental agencies (e.g., nice in the uk and ceps in france) regulate medication prices. these regulating entities could oversee compulsory licensing. these regulating entities (e.g., france) benchmark the price of the generic against the branded drug and vice-versa benchmark: when a generic enters, the price of the generic is fixed at 60% of the branded drug price.155 such an entity could combine the compulsory licensing with an automatic price drop as soon as a court holds that a patent holder engaged in a pay-for-delay agreement: i.e., the branded drug would be set at 60% of its originally negotiated price. in doing so, the branded drug would not enjoy the remainder of the patent. finally, the courts and regulatory entity could avoid oversight issues 149. see colleen chien, cheap drugs at what price to innovation: does the compulsory licensing of pharmaceuticals hurt innovation, 18 berkeley tech. l.j. 853 (2003) (discussing compulsory licensing in the pharmaceutical industry in the united states). 150. see id.; petra moser & alessandra voena, compulsory licensing: evidence from the trading with the enemy act, 102 am. econ. rev. 396 (2012) (finding compulsory licenses boosted domestic inventions). 151. see agreement on trade-related aspects of intellectual property rights, apr. 15, 1994, marrakesh agreement establishing the world trade organization. 152. id. at art. 8. 153. id. 154. see paul l. joskow, transaction cost economics, antitrust rules, and remedies, 18 j. law, econ. & org. 95 (2002) (discussing why courts favor certain remedies). 155. rémond, supra note 89. 2022] reverse payment: a comparative study 43 altogether by rendering the patent(s) used to protect the branded drug unenforceable. this unenforceability would extend to any compound that serves the same therapeutic treatment or any patents that cover the manufacturing process. patents obtained through fraud can violate antitrust laws.156 the u.s. supreme court has expressed that patents are like a “public franchise.”157 an unlawful pay-for-delay amounts to an illegal extension of the public franchise that defrauds the public. policymakers should investigate how to make unenforceable any patent maintained through anticompetitive behavior. b. beyond regulated prices countries like france benchmark the pricing of generics against the branded drug manufacturer. while the benefits of those settlements are smaller than in other jurisdictions (e.g., the us), this approach still incentivizes pay-for-delay settlements. regulators can deter many practices by regulating the period of exclusivity and attaching generic market entry to the branded market authorization instead of the patent protection. regulators already ignore patent validity when they guarantee years of exclusivity.158 while pharmaceutical companies could use patents to protect their innovation during their research and development, the market exclusivity of a drug period should not be linked to patents. first, such an approach could streamline market entry because generic manufacturers would no longer have to carry out a patent clearance studies. instead, they could safely enter a market knowing that the statutory period has expired. alleviating some patent uncertainties would promote generic entry. regulatory agencies should investigate what should be the optimal statutory period. currently, patent protection duration varies from drug to drug because some manufacturers extend their protection through process patent protection or compound protection. drug manufacturers complain that patent protection is necessary because research and development for drugs are expensive and that only a few drugs pan out.159 however, much of this complaint seems 156. see e.g., walker process equipment, inc. v. food machinery & chemical corp., 382 u.s. 172 (1965) (holding enforcing a patent obtained through fraud on the patent office may be violative of the sherman act); therasense inc. v. becton dickinson and co., 649 f.3d 1276, 1288 (fed. cir. 2011) (“[i]nequitable conduct regarding any single claim renders the entire patent unenforceable,” “cannot be cured by reissue,” and “can spread from a single patent to render unenforceable other related patents and applications in the same technology family.”). 157. oil states energy v. greene's energy group, 138 s. ct. 1365 (2018). the us supreme court has referred to patent as “public franchise” instead of a right akin to property rights. id. 137374. so, patents can be revoked without compensation or a review from article iii courts under the seventh amendment. 158. valerie junod, drug marketing exclusivity under united states and european union law, 59 food & drug l.j. 479 (2004). 159. melanie j. brown, reverse payment settlements in the european commission's pharmaceutical sector inquiry report: a missed opportunity to benefit from u.s. experience, 33 44 indiana health law review [vol. 19:21 exaggerated. first, most of the manufacturers’ cost are not linked to research. in a survey, the european commission found that drug manufacturers spent more on marketing and promotion than on research (21% versus 18% of annual costs) in 2007.160 the scale of marketing costs may also be underestimated: an industry observer noted that some marketing costs are classified as research costs.161 this observation in europe is surprising because most european countries do not allow most drugs to be advertised to consumers.162 second, the cost survey did not ask about litigation costs. however, during a hearing, congresswoman katie porter pointed out that abbvie spent $1.6 billion on litigation and settlements, $2.45 billion on research and development, and $4.71 billion on marketing between 2013 and 2018.163 in total, abbvie’s litigation and settlements and marketing budgets were more than double its research budget. incentivizing research and bringing drugs to the market through patent protection leads to more expenditure on rent-seeking than on research. abbvie is one of the companies most involved in us pay-for-delay cases.164 the abbvie expenditures show that the period of exclusivity approach would reduce the need for these litigations and settlements, many of which have been linked to pay-for-delay and the litigations discussed above. ignoring marketing costs in the exclusivity calculation would disincentivize poor practices as well. second, regulatory agencies should investigate the optimal statutory protection period. these protection period may not need to be identical. instead, colum. j.l. & arts 377, 378-79 (2009). 160. ec report, supra note 4, table 4. 161. id. at fn. 51. 162. for example, in france, article l. 5122-1 to l. 5122-16 code de la santé publique (french public health code) regulates advertisement to the general public and medical professionals. article l. 5122-6 prohibits the direct advertisement to the general public of prescription-only medicinal products (i.e., « la publicité auprès du public pour un médicament n'est admise qu'à la condition que ce médicament ne soit pas soumis à prescription médicale » which translate to advertising the public for any medication is only possible if this medication is not subject to medical prescription (authors’ translation)). 163. tim dickinson, katie porter delivers another knockout punch, rolling stone (may 19, 2021, 3:51 pm), https://www.rollingstone.com/politics/politics-news/katie-porter-abbviegonzalez-big-pharma-knockout-punch-1171735/ [https://perma.cc/4als-xpj6]. 164. abbvie or abbvie subsidiaries have been involved in at least ten federal pay-for-delay antitrust cases since 2003: andrx pharms., inc. v. biovail corp., int’l, 256 f.3d 799 (d.c. circ. 2001); in re cardizem cd antitrust litig., 332 f.3d 896 (6th cir. 2003); arkansas carpenters health & welfare fund v. bayer ag, 604 f.3d 98 (2d cir. 2010); ark. carpenters health & welfare fund v. bayer ag (in re ciprofloxacin hydrochloride antitrust litig.), 544 f.3d 1323 (fed. cir. 2008); ftc v. watson pharms., inc., 677 f.3d 1298 (11th cir. 2012); ftc v. actavis, inc., 570 u.s. 136 (2013); in re loestrin antitrust litigation, nos. 14-2071, 15-1250, 2016 wl 698077 (1st cir. 2016); in re wellbutrin xl antitrust litigation, 868 f.3d 132, 141 (3d cir. 2017); in re actos direct purchaser antitrust litig., 414 f. supp. 3d 635, 640 (s.d.n.y. 2019); ftc v. abbvie inc., 976 f.3d 327 (3d cir. 2020). 2022] reverse payment: a comparative study 45 the regulatory agency could change the statutory protection based on the type of diseases and/or the existing therapeutical treatment. these governmental already do a cost-efficiency analysis to award prices: they could do the same to award protection. the period should also depend on whether the drug gained its first market authorization, or the drug uses molecules that were already approved for a different therapeutic treatment. an additional therapeutic application does not involve the same cost of development as a novel application and hence should not be rewarded with the same exclusivity period. in other words, the period could depend on the marginal benefit of the drug. more importantly, such an approach would avoid pay-for-delay. patent validity would become irrelevant, and the generics could enter as soon as the statutory period is over. furthermore, the agency could also terminate the statutory protection if the brand manufacturer were found to be acting anticompetitively. while such widescale reform is unlikely because of vested interest, if nothing, the coronavirus pandemic has reinforced to many that the current healthcare system – including drug treatment – needs to be revisited. it is a unique market where the market participants have always found new ways to profit at the consumers’ expense. the death sentence that is america’s toxic prisons taylor carpenter* i. introduction seeing inequity in the environmental protection of their communities, concerned citizens started the environmental justice movement in the 1960s, and attempted to address the burden of environmental harms on minority and lowincome communities.1 the environmental justice movement strives for “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income, with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.”2 all peoples having the same protection from environmental and health hazards and having equal access to the decision-making for a healthy community is ultimately the goal of the movement.3 our country’s inmates suffer from environmental injustice and have been largely left out of the movement until fairly recently.4 however, the inmates’ plight is a pressing environmental justice issue because of their exposure to environmental and health hazards, and the large number of incarcerated minorities.5 the health and environmental hazards in prisons disproportionately impact minority populations because minority populations are disproportionately incarcerated.6 for example, in indiana, whites makeup eighty-two percent of the total population, but only comprise fifty-nine percent of the incarcerated population.7 in contrast, blacks make up thirty-four percent of the incarcerated population while only making up nine percent of the total population.8 this * indiana university robert h. mckinney school of law, j.d. candidate, 2020; bachelor of arts, 2016, university of georgia. 1. environmental justice, u.s. envtl. protection agency, https://www.epa.gov/ environmentaljustice [https://perma.cc/rk4y-98yq]. 2. id. 3. id. 4. andrea c. armstrong, death row conditions through an environmental justice lens, 70 ark. l. rev. 203, 207 (2017). 5. nathalie prescott, prisoner (in)consideration in environmental justice analyses, geo. envtl. l. rev. online (2016). 6. leah sakala, breaking down mass incarceration in the 2010 census: state-by-state incarceration rates by race/ethnicity, prison pol’y initiative (may 28, 2014), https://www. prisonpolicy.org/reports/rates.html [https://perma.cc/yxl7-krtd]. 7. graph showing whites are underrepresented in indiana prisons and jails, prison pol’y initiative, https://www.prisonpolicy.org/graphs/2010percent/in_whites_2010.html [https://perma.cc/l5sp-ymur]. 8. graph showing blacks are overrepresented in indiana prisons and jails, prison pol’y initiative, https://www.prisonpolicy.org/graphs/2010percent/in_blacks_2010.html [https://perma. cc/bd6v-dbpf]. 230 indiana health law review [vol. 17:229 disparity illustrates why inmates need to be included in the environmental justice movement—it’s supposed to protect these vulnerable groups of people.9 so far, the discussions examining inmate health through an environmental justice lens has largely focused on the building sites for new prisons.10 however, the recent addition of the prison layer to the environmental protection agency’s (hereinafter “epa”) “environmental justice and screening tool” is an example of the positive progress in this area.11 according to the epa, the tool uses national data and amalgamates environmental and demographic indicators into maps and reports.12 the tool allows users to find areas with: “minority and/or low-income populations, potential environmental quality issues, [and] a combination of environmental and demographic indicators that is greater than usual.”13 the prison layer allows users to analyze the location of prisons, jails, and detention centers in relation to environmental hazards.14 the addition of the prison layer is a big step for the growing national movement of environmental justice for inmates and for analyzing prisons from an environmental justice perspective.15 as the discussion surrounding the environmental and health hazards of prisons progresses, our country needs to start examining legal solutions to the problem—solutions that will lead to fewer exposures and better quality of life for those men and women who are forced to live in a particular place. ii. toxic prisons there are different types of exposures in different prisons across the country.16 inmates’ conditions vary from breathing in coal ash to exposure to nuclear waste, which illustrates why there is no one simple solution to the problem.17 however, this country cannot allow this problem to continue and let a simple prison sentence essentially become a death sentence for those inmates who are exposed to these toxins. 9. prescott, supra note 5. 10. armstrong, supra note 4, at 213-14. 11. zoe loftus-farren, epa adds prison locations to its environmental justice mapping tool, eco watch (sept. 21, 2017), https://www.ecowatch.com/prison-locations-environmentaljustice-2488013644.html [https://perma.cc/7kw5-4fm3]. 12. ejscreen: environmental justice screening and mapping tool, envtl. prot. agency, https://www.epa.gov/ejscreen [https://perma.cc/bg9j-y3e4]. 13. purposes and uses of ejscreen, envtl. prot. agency, https://www.epa.gov/ejscreen/ purposes-and-uses-ejscreen [https://perma.cc/l3de-ntus]. 14. loftus-farren, supra note 11. 15. id. 16. candice bernd, maureen nandini mitra & zoe loftus-farren, america’s toxic prisons: the environmental injustices of mass incarceration, truthout (jun. 1, 2017), https://truthout.org/ articles/america-s-toxic-prisons-the-environmental-injustices-of-mass-incarceration/ [https://perma.cc/rlc2-hhsc]. 17. id. 2020] the death sentence that is america’s toxic prisons 231 this note will explore four examples of toxic prisons or detention centers already in operation and one currently being built that could potentially cause similar health concerns in later years. these toxic prisons and detention centers are unconstitutional and should not be in operation. a. coal ash exposure—sci fayette (pennsylvania) as of february 28, 2019, fayette state correctional institute was at 98.8 percent capacity with its total institute population at 2,104.18 the pennsylvania general assembly voted to authorize the facility in 1997; ground was broken in march of 2000, and the inmates arrived in august of 2003.19 the facility is located on a corner of “what, in the 1940s through the 1970s, was once one of the largest coal preparation plants in the world.”20 here the coal was washed and graded, and the clean coal was sent off, and the leftover coal refuse was dumped at the site.21 by the mid-1990s, about 40 million tons of coal refuse had been dumped at the site.22 the site was eventually purchased by a local company that partnered with the pennsylvania department of environmental protection to dump a different type of coal byproduct on the site—coal ash.23 coal ash is a waste produced when coal is burned at power plants; more than 5 million tons of coal ash has been dumped at the site since 1997.24 coal ash is more toxic than unburned coal because it contains higher concentrations of heavy metals and minerals (mercury, lead, arsenic, hexavalent chromium, cadmium, boron, and thallium).25 the site at issue here is unlined and these contaminants can not only get into the local water sources but also blow in the air as “fugitive dust”.26 “if eaten, drunk or inhaled, these toxicants can cause cancer and nervous system impacts such as cognitive deficits, developmental delays and behavioral problems.”27 “they can also cause heart damage, lung disease, respiratory distress, kidney disease, reproductive problems, 18. pennsylvania department of corrections monthly population report (feb. 28, 2019), pa. dep’t of corrections, https://www.cor.pa.gov/about%20us/statistics/documents/current% 20monthly%20population.pdf [https://perma.cc/22yt-z6cx]. 19. sci fayette, pa. dep’t of corrections, https://www.cor.pa.gov/facilities/stateprisons/ pages/fayette.aspx [https://perma.cc/3whd-8yhz]. 20. bernd, mitra & loftus-farren, supra note 16. 21. id. 22. id. 23. id. 24. id. 25. id. 26. id. 27. coal ash: hazardous to human health, physicians for soc. resp., https://www.psr. org/wp-content/uploads/2018/05/coal-ash-hazardous-to-human-health.pdf [https://perma.cc/xpl3fdrz]. 232 indiana health law review [vol. 17:229 gastrointestinal illness, birth defects, and impaired bone growth in children.”28 other health conditions that coal ash can cause or contribute to include “respiratory problems, hypertension, heart problems, brain and nervous system damage, liver damage, stomach and intestinal ulcers, and many forms of cancer, including skin, stomach, lung, urinary tract and kidney.”29 living near a coal ash disposal site can increase your risk of getting cancer and other diseases, according to the epa.30 when the dumping started at the site, the residents of the nearby town of labelle began getting sick and reported respiratory problems, kidney failure, and cancers.31 they blamed the dumping site.32 then, when sci fayette was built, inmates and staff began experiencing health problems similar to those of the local residents.33 the abolitionist law center and the human rights coalition conducted a 12-month investigation into the health impacts of exposure to toxic coal waste on the inmates at fayette.34 their investigation found several troubling statistics among reporting inmates.35 for example, about “81% of responding prisoners (61/75) reported respiratory, throat, and sinus conditions, including shortness of breath, chronic coughing, sinus infections, lung infections, chronic obstructive pulmonary disease, extreme swelling of the throat, as well as sores, cysts, and tumors in the nose, mouth, and throat.”36 additionally, “68% (51/75) of responding prisoners experienced gastrointestinal problems, including heart burn, stomach pains, diarrhea, ulcers, ulcerative colitis, bloody stools, and vomiting.”37 also, “52% (39/75) reported experiencing adverse skin conditions, including painful rashes, hives, cysts, and abscesses.”38 moreover, “12% (9/75) of prisoners reported either being diagnosed with a thyroid disorder at sci fayette, or having existing thyroid problems exacerbated after transfer to the prison.”39 and finally, “[e]leven prisoners died from cancer at sci fayette between january of 2010 and december of 2013. another six prisoners have reported being diagnosed with cancer at sci fayette and a further eight report undiagnosed tumors and lumps.”40 28. id. 29. bernd, mitra & loftus-farren, supra note 16. 30. coal ash: hazardous to human health, supra note 27. 31. bernd, mitra & loftus-farren, supra note 16. 32. id. 33. id. 34. dustin s. mcdaniel, bret grote, ben fiorillo, devon cohen & quinn a. cozzens, no escape: exposure to toxic coal waste at state correctional institution fayette (2014) 1, http://abolitionistlawcenter.org/wp-content/uploads/2014/09/no-escape-3-3mb. pdf [https://perma.cc/l67l-sk2l]. 35. id. 36. id. 37. id. 38. id. 39. id. 40. id. at 2. 2020] the death sentence that is america’s toxic prisons 233 while one cannot definitively say that all of these prisoners experienced these conditions because of their exposure to coal ash, the statistics are alarming.41 the report asserts these prisoner’s symptoms did not begin to appear until they arrived at fayette—this is different from health reports from other pennsylvania prisons.42 “the patterns of illnesses described in this report, coupled with the prison being geographically enveloped by a toxic coal waste site, point to a hidden health crisis impacting a captive and vulnerable population.”43 the report states that while they believe the inmates’ health issues are caused by the toxic environment around the prison, “the inherent limitations of the survey do not establish this belief at an empirical level.”44 the authors of the study understand that there will be more investigation needed to establish the connection between the inmates’ health and exposure.45 the authors’ understanding that there needs to be more research done to establish a relationship between the coal ash exposure and the inmates’ declining health mirrors the big hurdle ligation will face in this arena—causation. b. toxic sludge—northwest detention center (washington) the northwest detention center, located in tacoma, washington, holds undocumented immigrants and is located next to the tacoma’s tar pits.46 the tar pits are a superfund site.47 superfund is the informal name for the comprehensive environmental response, compensation and liability act (hereinafter “cercla”), which gives the epa the authority to clean up contaminated sites.48 in addition, the act “forces the parties responsible for the contamination to either perform cleanups or reimburse the government for epa-led cleanup work.”49 the tar pits were once wetlands, however, that were filed in and used for industrial purposes.50 one such purpose was coal conversion, which produced 41. id. at 20. 42. id. at 6. 43. id. at 2. 44. id. 45. id. 46. michael waters, how prisons are poisoning their inmates, the outline (july 23, 2018, 10:40 am), https://theoutline.com/post/5410/toxic-prisons-fayette-tacoma-contaminated? zd=1&zi=ya5d6dym [https://perma.cc/4upv-z6ka]. 47. superfund site information: tacoma tar pits, u.s. envtl. prot. agency, https://cumulis.epa.gov/supercpad/cursites/csitinfo.cfm?id=1000965 [https://perma.cc/xbr678rn]. 48. what is superfund?, u.s. envtl. prot. agency, https://www.epa.gov/superfund/whatsuperfund [https://perma.cc/3dv3-dmsa]. 49. id. 50. dan mcshane, the grassy knoll tacoma’s, reading the washington landscape (may 13, 2010, 6:32 pm), https://washingtonlandscape.blogspot.com/2010/05/grassy-knoll234 indiana health law review [vol. 17:229 coal tar as waste.51 “the tar was disposed of by discharging it into the wetlands and other low areas around the site.”52 a preliminary final environmental impact statement for the tacoma/seattle detention center found that the j street location (what became the location of the center), “contains undefined levels of hazardous waste contamination that exceeds established regulatory levels for both soil and groundwater.”53 this, along with the fact that the site is located abject to the tar pits led the report to say the site presented “an undefined risk associated with redevelopment of the site resulting in liability concerns.”54 the report, therefore, selected a port site as the preferred alternative to the j street location.55 however, port officials did not like this finding and turned to congressmen and other politicians to fight the decision.56 the “the agency ultimately changed its conclusions. its final recommendation for a new northwest detention facility did not identify a preferred building site, describing both as satisfactory for the project.”57 the newspaper who reported on this issue had three environmental attorneys analyze the review process, and all three said it was unusual in several ways.58 first, the lawyers pointed out that the state and federal studies were not synchronized, which normally happens.59 “such coordination typically occurs partly because federal law requires that until a final decision on a federal environmental review has been made, ‘no action concerning the proposal shall be taken.’”60 secondly, the correctional services corporation “sought a separate state environmental determination . . . only for one of the site alternatives in play—the east j street site,” and “[t]he city issued that determination several months before the federal decision had been made.”61 and third, “the federal review’s final impact statement did not identify a preferred site alternative as is usually required. under federal law, a final environmental impact statement must identify the agency’s preferred alternative, ‘unless another law prohibits the expression of tacomas.html [https://perma.cc/j43j-8wqy]. 51. id. 52. id. 53. immigration and naturalization serv., preliminary final environmental impact statement for the tacoma/seattle area detention center, pierce county, washington (feb. 2001), http://www.documentcloud.org/documents/408887-snewsroomp12081312560.html#document/p2/a67579 [https://perma.cc/43jl-4d42]. 54. id. 55. id. 56. lewis kamb, a rare look inside tacoma’s northwest detention center, investigatewest (sept. 9, 2012), http://www.invw.org/2012/09/09/a-rare-look-inside-tacoma1309/ [https://perma.cc/v6rp-y6zl]. 57. id. 58. id. 59. id. 60. id. 61. id. 2020] the death sentence that is america’s toxic prisons 235 such a preference.’”62 the draft report had taylor way as the preferred building site, but “the final report stated federal bidding regulations ‘prohibit ins from identifying the preferred site prior to entering into a contract for the facility.’”63 the center was built on the site despite warnings,64 and there are still health concerns at the center—particularly about the water.65this one example illustrates how economic and political pressure can cause a prison to be built on toxic land and result in an entire inmate population to get exposed to environmental hazards. c. toxic nuclear waste—adx florence (colorado) adx florence is the highest-security prison in the united states and is known for housing notorious inmates as well as inmates who are flight or behavior risks.66 the cotter uranium mill is located a few miles away from florence and once produced yellowcake; the mill “produced and stored radioactive chemicals like uranium, vanadium, and molybdenum.”67 the mill stored “more than 3.5 million tons of radioactive waste and much of that was stored in lined ponds — which are usually around 40 feet deep — meant to keep materials from leaking out.”68 waste from the mill overflowed from “unlined impoundments” into a creek that flowed into the arkansas river, which was a water source for nearby communities.69 a ditch was constructed in the 1970s to prevent the creek from flowing into the river, but it overflows during irrigation season.70 “although the bop expressed concerned in 1989 that the prison’s water supply may have to be rerouted in the future due to pollution, a water quality report shows that the arkansas still remained a source for the city’s water supply as late as 2013.”71 the epa declared the mill a superfund site in 1984, stating that “waste from the mine had seeped into the groundwater and contaminated local wells.”72 seventy leaks were reported between 1980 and 1986, and a state of colorado 62. id. 63. id. 64. id. 65. id. 66. mark binelli, inside america’s toughest federal prison, n.y. times (mar. 26, 2015), https://www.nytimes.com/2015/03/29/magazine/inside-americas-toughest-federal-prison.html [https://perma.cc/6byb-3n7c]. 67. waters, supra note 46. 68. id. 69. laura cepero, toxic traps: environmental hazards threaten two federal supermax prisons, solitary watch (sept. 10, 2015), https://solitarywatch.org/2015/09/10/toxic-trapsenvironmental-hazards-threaten-two-federal-supermax-prisons/ [https://perma.cc/a9mu-hwct]. 70. id. 71. id. 72. id. 236 indiana health law review [vol. 17:229 investigation “concluded that drainage from the cotter mine spilled into the fremont ditch, resulting in elevated levels of molybdenum, arsenic, lead, and other contaminants.”73 in addition, 19.9 tons of radioactive dust were released into the air every year the mill was in operation, and because florence lies in the mill’s wind pattern “the prison and its inhabitants are subject to gusts of radium, uranium, and thorium.”74 the mill is still a superfund site, “but the contamination concerns . . . appear to be dwindling thanks to cleanup efforts (the site isn’t expected to lose superfund status until at least 2027),” and “potential public exposures are below regulatory limits.”75 nonetheless, inmates have spoken about their health issues and those they have observed in other inmates that they believe to be caused by exposure.76 d. industrial solvents and nuclear contamination— fci victorville (california) victorville federal correctional complex consists of three facilities and houses thousands of inmates in san bernardino county.77 it is built on what was once george air force base.78 the base closed in 1992 and opened in 1941 just before the united states joined the fight in world war ii.79 there were reports of soil contamination on base in 1977 which included pesticide contamination near base housing.80 by 1981 medical personnel were advising women not to get pregnant while being stationed at the base because of the high infant mortality rate.81 in the 1980s the air force acknowledged contamination by jet fuel, gasoline, paints, and solvents.82 the air force initially denied any nuclear waste testing at the base, however, it has since become clear that there was nuclear and other radioactive work done on the base, and that radioactive materials were disposed of there.83 in 1979, environmental tests done by the u.s. air force 73. id. 74. id. 75. waters, supra note 46. 76. id. 77. fci victorville medium ii, fed. bureau of prisons, https://www.bop.gov/locations/ institutions/vvm/ [https://perma.cc/2688-mt66]; fci victorville medium i, fed. bureau of prisons, https://www.bop.gov/locations/institutions/vim/ [https://perma.cc/am8w-c9gx]; usp victorville, fed. bureau of prisons, https://www.bop.gov/locations/institutions/vip/ [https:// perma.cc/9328-qj3t]. 78. waters, supra note 46. 79. mark gutglueck, air force less than clear on extent of nuclear contamination at gafb, san bernardino county sentinel (may 17, 2015), http://sbcsentinel.com/2015/05/airforce-less-than-clear-on-extent-of-nuclear-contamination-at-gafb/ [https://perma.cc/xrp3-5etq]. 80. id. 81. id. 82. id. 83. id. 2020] the death sentence that is america’s toxic prisons 237 found “18 to 20 55-gallon drums of radioactive material…had been dumped at the site.”84 in 2016 the california water boards requested soil sampling be done at school sites now on the former base.85 the boards were concerned about pesticide contamination because pesticides had been applied at the former housing area beneath and around the building foundations for terminate control purposes.86 one of the pesticides used was dieldrin, “a toxic chlorinated pesticide that is relatively persistent and immobile,” and was banned in the united states by 1987; it can “cause adverse health effects when present at high concentrations.”87 “dieldrin has been linked to human health problems including parkinson’s disease and breast cancer, and damage to the immune, reproductive, and nervous systems.”88 several service members who were stationed at the base think radioactive waste caused their health problems.89 for example, kenn finkelstein was stationed at the base and said “he developed hundreds of warts on his feet before later losing a kidney to cancer.”90 furthermore, he was “discharged for health reasons in 1974 after suffering seizures, migraines, and excessive bleeding because of radiation exposure.”91 another example of health problems at the base is illustrated by the fact that women there were warned not to get pregnant during the 1990s due to “disproportionate numbers of hysterectomies, miscarriages, and babies born with birth defects.”92 fci victorville was built twelve years after the base closed down.93 the epa is letting the toxic water degrade on its own rather than clean it up as part of its policy of monitored natural attenuation.94 the california water boards found that this waiting policy means it will take over 500 years for the water to be restored.95 several prisoners blame the contaminated water for their health concerns.96 after eric mcdavid was released, he found elevated levels of copper in his 84. waters, supra note 46. 85. cal. water bds, request for soil sampling at the school properties, noncercla site ot071, former george air force base, victorville, san bernardino county (april 8, 2016) 1, https://truthout.org/wp-content/uploads/legacy/documents/2016_0417soil-sampling-at-schools.pdf [https://perma.cc/wzk4-t3g4]. 86. id. 87. id. at 1-2. 88. id. at 2. 89. waters, supra note 46. 90. id. 91. id. 92. id. 93. id. 94. id. 95. id. 96. id. 238 indiana health law review [vol. 17:229 system.97 he says the copper levels were “40 times higher than what it should have been.”98 pauline blake was detained in victorville from 2011 to 2016 and said that the inmates were told to only drink water and that it sometimes was “a grayish-brown,” after it went through a filter.99 blake said the guards would not drink the water.100 blake also said the prison “saw an outbreak of stomach ulcers caused by the bacterium h. pylori.”101 e. indianapolis’s new criminal justice center the city of indianapolis broke ground on a new criminal justice center in july of 2018.102 the new center is being constructed on the former citizens energy coke plant and is scheduled to be completed in 2021.103 the site “will undergo environmental remediation with the indiana department of environmental management and experts from purdue university.”104 construction of the center will begin once the site remediation is completed, but before water quality is restored.105 jeffrey harrison, ceo of citizens energy group said “the long-term goal is that the water quality of the site will be restored by 2025.”106 the city is leasing the contaminated land for the time being and will take full ownership citizens completes its remediation work.107 “coke is a fuel and reducing agent in melting iron ore.”108 citizens produced coke on the site for 99 years.109 the plant closed in 2007, but the land and creek 97. id. 98. id. 99. id. 100. id. 101. id. 102. indianapolis breaks ground on robust new criminal justice center, correctional news (july 19, 2018), http://correctionalnews.com/2018/07/19/indianapolis-breaks-ground-robustnew-criminal-justice-center/ [https://perma.cc/35x6-vllr]. 103. id. 104. fatima hussein, indianapolis takes next step toward long-sought new criminal justice center, indystar (dec. 18, 2017), https://www.indystar.com/story/news/2017/12/18/indianapolist akes -n ex t -s t ep-tow ard-lon g-sou gh t -n ew -cr im in al-just ice-cen ter/96 0 5 9 0 0 0 1 / [https://perma.cc/mgr4-buk6]. 105. id. 106. id. 107. id. 108. how does coke and coal play into steel making?, fed. steel supply, inc. (june 22, 2016), https://www.fedsteel.com/our-blog/how-does-coke-and-coal-play-into-steel-making/ [https://perma.cc/3hgc-4fg7]. 109. russ mcquaid, $24 million in cleanup continues at proposed site for new criminal justice complex, fox59 (feb. 7, 2017, 9:05 am), https://fox59.com/2017/02/07/24-million-incleanup-continues-at-proposed-site-for-new-criminal-justice-complex/ [https://perma.cc/pe6zhgsw]. 2020] the death sentence that is america’s toxic prisons 239 bed on the site were polluted from coal tar deposits.110 “coal tar is derived from coal. it is a byproduct of the production of coke…and coal gas. coal tar is used primarily for the production of refined chemicals and coal-tar products, such as creosote and coal-tar pitch.”111 coal tar can be a carcinogen in heavy concentrations.112 citizens has been cleaning up the site for a decade and has spent $12 million “on environmental studies as well as some environmental remediation work.”113 when the cleanup first started citizens stated that their studies indicated that the “contamination is contained on the site and therefore, does not pose a danger to public health as defined by the u.s. environmental protection agency.”114 citizens said they were focused on protecting a waterway “from potential effects from the plant site.”115 the waterway is “impacted by a variety of sources of pollution, including overflows from the aging sewer system that citizens acquired in 2011.”116 citizens states they will complete “an underground tunnel system that will virtually eliminate sewer overflows” in waterways over the next 11 years.117 a corporate communications manager for citizens “said coal tar deposits on the land are inert and don’t migrate but have settled into the bed of [the waterway], which runs through the land”118 the manager also said they found some coal tar deposits in the sediments and mud of the creek.119 according to the manager, citizens planned to start removing these deposits in the summer of 2017.120 the manager also said while there were “some impacts to the shallow groundwater” there were no impacts to the deep ground.121 the manager at citizens said the coal tar at the site for the new justice center is: not a threat to human health . . . in some cases, the coal tar deposits will be removed. in other cases, they will be left in place because they pose no threat to human health or the environment, so they’ll be paved over. “in areas where there’s buildings there will be appropriate measures of 110. id. 111. coal tar and coal-tar pitch, nat’l cancer inst., https://www.cancer.gov/aboutcancer/causes-prevention/risk/substances/coal-tar [https://perma.cc/7cy7-xjtb] (last updated dec. 28, 2018). 112. mcquaid, supra note 109. 113. id. 114. jeff harrison, citizens energy working to clean up old coke plant site, indystar (may 16, 2014, 4:10 pm), https://www.indystar.com/story/opinion/readers/2014/05/16/citizensenergy-working-clean-old-coke-plant-site/9184973/ [https://perma.cc/39sk-jpl5]. 115. id. 116. id. 117. id. 118. mcquaid, supra note 109. 119. id. 120. id. 121. id. 240 indiana health law review [vol. 17:229 remediation taken to accommodate those buildings and in other areas where there’s parking lots, there’ll be another level of remediation.122 the site was chosen because of its “size, location, access to main streets, proximity to criminal justice challenges and acceptance of neighbors.”123 the new criminal justice center has been pitched as a win for the community. mayor hogsett said: for nearly a century in the twin aire neighborhood, the former citizens energy coke plant helped fuel the steel industry. but since operations ceased in 2007, that land has stood vacant and the neighborhood has yearned for community development and investment. today is a testament to the community members and neighborhood leaders who tirelessly advocated for the community justice campus in twin aire.124 however, building a new prison on such a contaminated site should cause our community to pause. yes, a new, not overcrowded prison is good. yes, bringing new jobs to an area that lost so many when a factory left the neighborhood is good. however, these are these were the same promises made when prisons were built in coal country.125 and as a community indianapolis needs to not only hold the citizens accountable for the pollution they caused to the neighborhood but also the community needs to hold the city of indianapolis responsible before they house 3,000 inmates on land that could potentially cause them health problems in the future.126 iii. the unconstitutionality of toxic prisons forcing inmates to live on toxic land is unconstitutional not only an environmental justice concern since it disproportionately affects minorities and low-income individuals, but it is also unconstitutional.127 these exposures are unconstitutional in two ways—first as a substantive due process violation under the fourteenth amendment, and second as a form of cruel and unusual punishment under the eighth amendment.128 it is a substantive due process violation because by building prisons on or near toxic land sites the government created a danger 122. id. 123. id. 124. jordan fischer & rafael sanchez, mayor hogsett announces old citizens energy coke plant to be site of new community justice campus, rtv6 indianpolis (jan. 30, 2017, 1:21 pm), https://www.theindychannel.com/news/crime/call-6-old-citizens-energy-coke-plant-to-be-siteof-new-criminal-justice-complex [https://perma.cc/5lhu-bhp8]. 125. see nicole greenfield, the connection between mass incarceration and environmental justice, nrdc (jan. 19, 2018) https://www.nrdc.org/onearth/connection-between-massincarceration-and-environmental-justice [https://perma.cc/27lg-evj3]. 126. see indianapolis breaks ground on robust new criminal justice center, supra note 102. 127. see sakala, supra note 6. 128. see u.s. const. amend. xiv; u.s. const. amend. viii. 2020] the death sentence that is america’s toxic prisons 241 that harmed the inmates—this, therefore, meets the danger creation exception.129 secondly, by being deliberately indifferent to the serious medical needs of the inmates these the government engaged in cruel and unusual punishment.130 a. substantive due process violation the exposures at issue here are substantive due process violations and are therefore unconstitutional under the fourteenth amendment. generally, the due process clause does not require the government to act to protect due process rights.131 however, the “danger creation exception” allows a substantive due process claim when the government “places a person in peril in deliberate indifference to their safety.”132 several circuits have recognized the danger creation exception.133 however, the elements for what meets this exception varies from circuit to circuit.134 for example, in the ninth circuit, a plaintiff must prove the “state action create[d] or expose[d] an individual to a danger which he or she would not have otherwise faced.”135 additionally, “the state action must place the plaintiff ‘in a worse position than that in which he would have been had the state not acted at all.’”136 furthermore, the plaintiff must also prove the “state actor . . . recognize[d] the unreasonable risks to the plaintiff and ‘actually intend[ed] to expose the plaintiff to such risks without regard to the consequences to the plaintiff.’”137 lastly, the state actor had to act with “[d]eliberate indifference,” which “requires a culpable mental state more than gross negligence.”138 in contrast, the third circuit’s elements for the danger creation exception are: (1) “the harm ultimately caused was foreseeable and fairly direct;” (2) a state actor acted with a degree of culpability that shocks the conscience; 129. see penilla v. city of huntington park, 115 f.3d 707, 709-10 (9th cir. 1997). 130. estelle v. gamble, 429 u.s. 97, 104 (1976). 131. deshaney v. winnebago county dep. of social services, 489 u.s. 189, 196 (1989). 132. penilla, 115 f.3d at 709. 133. see cornelius v. town of highland lake, 880 f.2d 348, 356 (11th cir. 1989); kneipp v. tedder, 95 f.3d 1199, 1208–1211 (3d cir. 1996); dwares v. city of new york, 985 f.2d 94, 99 (2d cir. 1993); reed v. gardner, 986 f.2d 1122, 1124-25 (7th cir. 1993); freeman v. ferguson, 911 f.2d 52, 54–55 (8th cir. 1990). 134. see bright v. westmoreland county, 443 f.3d 276, 281 (3d cir. 2006); juliana v. united states, 217 f. supp. 3d 1224, 1251 (d. or. 2016). 135. kennedy v. city of ridgefield, 439 f.3d 1055, 1061 (9th cir. 2006). 136. juliana, 217 f. supp. 3d at 1251 (quoting pauluk v. savage, 836 f.3d 1117, 1125 (9th cir. 2016)). 137. id. (quoting campbell v. wash. dep't of soc. & health servs., 671 f.3d 837, 846 (9th cir. 2011)). 138. pauluk v. savage, 836 f.3d 1117, 1125 (9th cir. 2016) (quoting patel v. kent sch. dist., 648 f.3d 965, 974 (9th cir. 2011). 242 indiana health law review [vol. 17:229 (3) a relationship between the state and the plaintiff existed such that “the plaintiff was a foreseeable victim of the defendant's acts,” or a “member of a discrete class of persons subjected to the potential harm brought about by the state's actions,” as opposed to a member of the public in general; and (4) a state actor affirmatively used his or her authority in a way that created a danger to the citizen or that rendered the citizen more vulnerable to danger than had the state not acted at all.139 while some of these elements are similar, the third circuit has more elements, and those elements impose a higher standard than the ninth circuit.140 therefore, this note will illustrate that the inmates’ claims would meet this higher standard and will examine the claims that would result from the exposures at fci victorville in particular. 1. reasonably foreseeable the first element “the harm ultimately caused was foreseeable and fairly direct.”141 in kneipp v. tedder, the third circuit held that the injuries to the plaintiff were foreseeable.142 there, samantha kneipp her husband joseph were returning on foot from a night of drinking, and according to joseph, “samantha was visibly intoxicated—she smelled of urine, staggered when she walked and, at times, was unable to walk without assistance.”143 a police officer stopped the kniepps, and samantha was leaning on the officer’s car because she was unable to stand by herself.144 joseph left at one point to check on the couple’s children that were with a babysitter and left to walk home, leaving samantha behind.145 he thought the officers were going to take samantha either the hospital or to the police station; “his thoughts at the time were that samantha should not be left alone in her inebriated state and that the police officers would take care of her, so he proceeded home without her.”146 however, the officer sent her home alone and she never made it.147 later that night samantha “was found unconscious at the bottom of an embankment next to a parking lot at the shopping plaza across the 139. bright, f.3d at 281 (quoting kneipp v. tedder, 95 f.3d 1199, 1208 (3d cir. 1996); citing county of sacramento v. lewis, 523 u.s. 833, 118 s. ct. 1708, 140 l. ed. 2d 1043 (1998); miller v. city of philadelphia, 174 f.3d 368, 375-76 (1999); schieber v. city of philadelphia, 320 f.3d 409, 416 (2003); quoting morse v. lower merion sch. dist., 132 f.3d 902, 906, 913 (3d cir. 1997); citing rivas v. city of passaic, 365 f.3d 181, 195 (3d cir. 2004); deshaney v. winnebago county dep't of social services, 489 u.s. 189, 201 (1989)). 140. see generally juliana, f. supp. 3d at 1251; bright, 443 f.3d at 281. 141. bright, 443 f.3d at 281 (quoting kneipp v. tedder, 95 f.3d 1199, 1208 (3d cir.1996)). 142. kneipp v. tedder, 95 f.3d 1199, 1208 (3d cir.1996). 143. id. at 1201. 144. id. 145. id. at 1202. 146. id. 147. id. 2020] the death sentence that is america’s toxic prisons 243 street from” her home.148 “as a result of her exposure to the cold, samantha suffered hypothermia, which caused a condition known as anoxia. consequently, the anoxia resulted in permanent brain damage impairing many basic body functions.”149 the court reasoned samantha’s injuries were reasonably foreseeable because an expert reported that at her high blood alcohol level of .25%, her muscular coordination would have been “seriously impaired.”150 additionally, the court said joseph’s testimony about having to help his wife walk showed her inability to walk.151 the court held samantha’s injuries were foreseeable because “[a] reasonable trier of fact could conclude that in samantha's state of intoxication, she would be more likely to fall and injure herself if left unescorted than someone who was not inebriated.”152 here it was reasonably foreseeable that the exposure to the toxins would cause injuries to the plaintiff because the government knew of and acknowledged the contamination on the land before the prison was built.153 for example, in 1979 about twenty drums of radioactive material were to have been dumped at the site.154 these drums were found “a quarter mile upstream of the wells used” at the base, and some believe the radioactive waste trickled directly into these wells because “[t]he groundwater flows northeast from the [radioactive dumping site], directly toward” the wells.155 the fact that the government knew about the contamination means that the harm was foreseeable because when one is aware of contamination it is reasonable to conclude that it might harm people, especially here because they also knew of the health problems associated with the contamination.156 this is evidenced by the fact that by 1981, medical personnel were advising women not to get pregnant while being stationed at the base because of the high infant mortality rate.157 because the government knew of the contamination and knew it could cause health problems, the harm caused was foreseeable. 2. shocks-the-conscience test the second element is that the “state actor acted with a degree of culpability that shocks the conscience.”158 courts have found behavior like the forced 148. id. 149. id. at 1203. 150. id. at 1208. 151. id. 152. id. 153. gutglueck, supra note 79. 154. waters, supra note 46. 155. id. 156. id. 157. gutglueck, supra note 79. 158. bright v. westmoreland county, 443 f.3d 276, 281 (3d cir. 2006) (citing county of 244 indiana health law review [vol. 17:229 pumping of an inmate’s stomach to shock the conscience.159 additionally, the supreme court said in county of sacramento v. lewis that actions constituting deliberate indifference can shock the conscience in certain circumstances.160 however, this is a fact-sensitive determination; the court in lewis said “[d]eliberate indifference that shocks in one environment may not be so patently egregious in another, and our concern with preserving the constitutional proportions of substantive due process demands an exact analysis of circumstances before any abuse of power is condemned as conscienceshocking.”161 there, the court held that a high-speed chase with “no intent to harm suspects physically or to worsen their legal plight” does not shock the conscience and does not violate the fourteenth amendment.162 nonetheless, they said deliberate indifference could be conscience shocking in custodial settings.163 they reasoned that this is because when the state takes someone into custody there is a constitutional duty to provide for their safety and well-being.164 “the rationale for this principle is simple enough: when the state by the affirmative exercise of its power so restrains an individual's liberty that it renders him unable to care for himself, and at the same time fails to provide for his basic human needs . . . it transgresses the substantive limits on state action set by the . . . due process clause.”165 the court considers the difference between in-custody and out-of-custody actions by police.166 they reasoned that prison officials have “time to make unhurried judgments, upon the chance for repeated reflection, largely uncomplicated by the pulls of competing obligations. when such extended opportunities to do better are teamed with protracted failure even to care, indifference is truly shocking.”167 the court then contrasts this to circumstances involving police in non-custody situations, stating “when unforeseen circumstances demand an officer's instant judgment, even precipitate recklessness fails to inch close enough to harmful purpose to spark the shock that implicates ‘the large concerns of the governors and the governed.’”168 an eighth circuit case succinctly states when using deliberate indifference for the shocks-the-conscience test is appropriate. “in cases where “defendants acted under circumstances in sacramento v. lewis, 523 u.s. 833, 118 s. ct. 1708, 140 l. ed. 2d 1043 (1998); miller v. city of philadelphia, 174 f.3d 368, 375-76 (1999); schieber v. city of philadelphia, 320 f.3d 409, 416 (2003)). 159. cty. of sacramento v. lewis, 523 u.s. 833, 846 (1998) (citing rochin v. california, 342 u.s. 165, 172-73 (1952)). 160. id. at 850. 161. id. 162. id. at 854. 163. id. at 851 164. id.. 165. id. (quoting deshaney v. winnebago county dept. of social servs., 489 u.s. 189, 199200 (1989). 166. id. at 851-53. 167. id at 853. 168. id. at 848 (quoting daniels v. williams, 474, u.s. 327, 332 (1986)). 2020] the death sentence that is america’s toxic prisons 245 which actual deliberation was practical . . . their conduct may shock the conscience of federal judges only if they acted with ‘deliberate indifference.’”169 here, because the inmates are in custody and actual deliberation was practiced, it is appropriate to analyze the conscience-shocking element through a deliberate indifference lens. the deliberate indifference standard applied in a substantive due process case is the same as that applied in eighth amendment cases.170 once again, the circuits’ standards for deliberate indifference vary slightly.171 for example, in the eighth circuit for deliberate indifference, “the official must both be aware of facts from which the inference could be drawn that a substantial risk of serious harm exists, and he must also draw the inference.”172 in contrast, the eleventh circuit held “deliberate indifference has three components: (1) subjective knowledge of a risk of serious harm; (2) disregard of that risk; (3) by conduct that is more than mere negligence.”173 this note will explore the eleventh circuit’s elements in a later section analyzing the cruel and unusual punishment claim. so, here the note will examine deliberate indifference using the eighth circuit’s elements to demonstrate how these inmates’ claims will be successful regardless of where the claims are brought. here the officials were “both . . . aware of facts from which the inference could be drawn that a substantial risk of serious harm exists,” and drew the inference.174 as stated previously, the government knew of and acknowledged the contamination on the land before the prison was built—this means that they were aware of the facts from which the inference could be drawn. furthermore, the government has been slowly attempting to clean up the site for twenty years, which is also evidence that they were aware of the contamination.175 additionally, they knew “trichloroethylene, a cancer-causing solvent, has contaminated two aquifers underneath the base and threatens a third aquifer, as well as the mojave river. it has also tainted monitoring wells at a nearby wastewater reclamation plant and forced workers there to drink bottled water as a precaution.”176 furthermore, the fact that as far back as 1981, medical personnel were advising women not to get pregnant while being stationed at the base because of the high 169. moore ex rel. moore v. briggs, 381 f.3d 771, 773 (8th cir. 2004) (citing cty. of sacramento v. lewis, 523 u.s. 833, 851-52 (1998)). 170. estate of johnson v. weber, 785 f.3d 267, 272 (8th cir. 2015). 171. see generally mcelligott v. foley, 182 f.3d 1248, 1255 (11th cir. 1999); see also estate of johnson, 785 f.3d at 272. 172. estate of johnson, 785 f.3d at 272 (citing moore ex rel. moore v. briggs, 381 f.3d 771, 773-74 (8th cir. 2004)). 173. mcelligott, 182 f.3d at 1255. 174. estate of johnson, 785 f.3d at 272 (citing moore ex rel. moore v. briggs, 381 f.3d 771, 773-74 (8th cir. 2004). 175. dan ross, why the epa is allowing contaminated groundwater to go untreated, newsweek (mar. 9, 2017), https://www.newsweek.com/2017/03/17/toxic-waste-contaminatedwater-monitored-natural-attenuation-epa-565830.html [https://perma.cc/6bna-hdjh]. 176. id. 246 indiana health law review [vol. 17:229 infant mortality rate is evidence that officials drew the inference that the contamination could cause health concerns.177 because the officials were aware of the contamination and of the health concerns associated with that contamination, they were deliberately indifferent to the plight of the men that would be housed there. this meets the shocks-theconscience test not only because these individuals are in custody, but also because the “defendants acted under circumstances in which actual deliberation was practical.”178 the governmental officials could have built the prison someone else, but they decided to put in on contaminated land with contaminated groundwater—they decided it was okay to force people to live on land that could kill them and that should shock one’s conscience. 3. relationship between the state and plaintiff the third element of the danger creation exception is “a relationship between the state and the plaintiff existed such that ‘the plaintiff was a foreseeable victim of the defendant's acts,’ or a ‘member of a discrete class of persons subjected to the potential harm brought about by the state's actions,’ as opposed to a member of the public in general.”179 in kneipp, the court held that there was “a relationship between the state and the person injured” because “[a] reasonable jury could find that [the] [o]fficer exerted sufficient control over samantha to meet the relationship requirement.”180 however, there was no real dispute as to whether or not a relationship existed.181 therefore, in morse v. lower merion school dis. the lower court examined the pre-kneipp decisions to understand the parameters of this requirement.182 the lower court analyzed doe v. methacton sch. dist. “which held that the state-created danger theory would only affix liability if the victim of the resulting harm is ‘known and identified,’ and not ‘simply a member of the greater public.’”183 here, at fci victorville for example, the inmates were not only a “foreseeable victim of the defendant’s acts,” but they were also a “discrete class of persons.”184 when the federal bureau of prisons decided to build the complex in southern california the foreseeable victims were those inmates who were going to be forced to live on the land. additionally, the inmates are a discrete class of persons and not members of the greater public because they were “known and identified”—they were inmates who were going to be sent to serve their time at 177. gutglueck, supra note 79. 178. moore ex rel. moore, 381 f.3d at 773. 179. bright v. westmoreland cty., 443 f.3d 276, 281 (quoting kneipp v. tedder, 95 f.3d 1199, 1209 (3d cir. 1996); morse v. lower merion sch. dis., 132 f.3d 902, 905-06 (3d cir. 1997)). 180. kneipp v. tedder, 95 f.3d 1199, 1209 (3d cir. 1996). 181. morse v. lower merion sch. dis., 132 f.3d 902, 906 (3d cir. 1997)). 182. id. 183. id. (quoting doe v. methacton sch. dist., 880 f. supp. 380, 386 (e.d. pa. 1995)). 184. see bright, 443 f.3d at 281. 2020] the death sentence that is america’s toxic prisons 247 fci victorville, not just members of the “greater public” who might happen to live on the contaminated land.185 4. state actor affirmatively used their authority to create a danger the fourth and final element of the danger creation exception is that “a state actor affirmatively used his or her authority in a way that created a danger to the citizen or that rendered the citizen more vulnerable to danger than had the state not acted at all.”186 there, the court explained, “while we have acknowledged that the line between action and inaction may not always be clear . . . we have never found a state-created danger claim to be meritorious without an allegation and subsequent showing that state authority was affirmatively exercised.”187 in kneipp for example, the court held that there was sufficient evidence to show that the officers “used their authority as police officers to create a dangerous situation or to make samantha more vulnerable to danger had they not intervened.”188 the court reasoned that by letting joseph go home alone and by keeping samantha before then letting her go “in a seriously intoxicated state in cold weather, made samantha more vulnerable to harm. it is conceivable that, but for the intervention of the police, joseph would have continued to escort his wife back to their apartment where she would have been safe.”189 here, the state “affirmatively used” its “authority in a way that created a danger” to the inmates by building a prison on toxic land.190 building a prison is an affirmative action. additionally, building it on contaminated land and is affirmative action taken by the government that created a danger. the second way this element can be met, and how it was met in kneipp, is when the state “rendered the citizen more vulnerable to danger than had the state not acted at all.”191 here, the inmates’ claims met this option for the fourth element as well because had the government not acted by not building the prison the inmates would have been less vulnerable to the danger of exposure. the inmates of fci victorville claims to due process violation meet the danger creation exception because (1) the harm to the inmates was foreseeable, (2) the government’s actions met the shocks-the-conscience test, (3) the inmates were the foreseeable victims of the government’s actions and (4) the government affirmatively used their authority to create the danger.192 for these reasons the 185. see morse, 132 f.3d at 906. 186. bright, 443 f.3d at 281. 187. id. at 282. 188. kneipp v. tedder, 95 f.3d 1199, 1209 (3d cir. 1996). 189. id. 190. see bright, 443 f.3d at 281. 191. bright, 443 f.3d at 281; kneipp, 95 f.3d at 1209. 192. see bright, f.3d at 281 (quoting kneipp v. tedder, 95 f.3d 1199, 1208 (3d cir. 1996); citing county of sacramento v. lewis, 523 u.s. 833, 118 s. ct. 1708, 140 l. ed. 2d 1043 (1998); miller v. city of philadelphia, 174 f.3d 368, 375-76 (1999); schieber v. city of philadelphia, 320 248 indiana health law review [vol. 17:229 toxic exposures discussed in this note are a substantive due process violation and are therefore unconstitutional. b. cruel and unusual punishment in addition to being a due process violation, these toxic prisons are also a form of cruel and unusual punishment and are therefore unconstitutional under the eighth amendment. the eighth amendment is violated when there is deliberate indifference to an inmate's serious medical needs.193 “to prevail on this type of claim a plaintiff must show (1) a serious medical need; (2) deliberate indifference to that need on the part of the defendant; and (3) causation between the defendant's indifference and the plaintiff's injury.”194 in clemmons v. bohannon the inmate plaintiff clemmons was a nonsmoker at the kansas state penitentiary.195 he alleged being involuntarily exposed to environmental tobacco smoke (hereinafter “ets”) violated his eighth amendment right to be free from cruel and unusual punishment.196 the court held that exposure to ets did not rise to an eighth amendment violation because there was no evidence that clemmons’ health was adversely affected by the cigarette smoke.197 additionally, clemmons did not demonstrate that the defendants were deliberately indifferent to serious medical needs.198 on the first issue of serious medical need, clemmons submitted affidavits about his exposure to ets.199 clemmons claimed he suffered from physical problems and medical problems as a result of . . . inhal[ing] carcinogens from the tobacco of inmates who smoke tobacco” on a “daily basis” and expose him to “toxic smoke fumes” and “stress.” clemmons alleges that he “suffers shortness of breath.” clemmons's pro se brief opposing summary judgment, signed but not sworn, states that his “throat, eyes and nose” were irritated by tobacco smoke and that this irritation required repeated medical care.200 the court reasoned that even if there were sufficient facts proving his injuries were linked to ets, “these symptoms alone do not compare to the medical needs that courts have found sufficiently serious to constitute an eighth amendment f.3d 409, 416 (2003); quoting morse v. lower merion sch. dist., 132 f.3d 902, 906, 913 (3d cir. 1997); citing rivas v. city of passaic, 365 f.3d 181, 195 (3d cir. 2004); deshaney v. winnebago county dep't of social services, 489 u.s. 189, 201 (1989)). 193. estelle v. gamble, 429 u.s. 97, 104 (1976). 194. mann v. taser intern, inc., 588 f.3d 1291, 1306-07 (11th cir. 2009). 195. clemmons v. bohannon, 956 f.2d 1523, 1524 (10th cir. 1992). 196. id. 197. id. at 1525. 198. id. 199. id. at 1526. 200. id. 2020] the death sentence that is america’s toxic prisons 249 violation.”201 the court cited several cases where the medical need did rise to an eighth amendment violation, and those medical needs were much more severe—for example, a “painful nasal deformity requiring surgery and head injury from being struck with a lead pipe may be sufficiently serious;”202 “gross medical deficiencies in prison resulting in undiagnosed tuberculosis, untreated broken back, and unattended abscessed rectum sufficiently serious,”203 and “deep, heavily bleeding eye injury requiring stitches sufficiently serious.”204 on the second requirement that the defendants were deliberately indifferent to the medical need, the court reasoned: even if we concede that exposure to ets can have serious medical consequences, the allegation of exposure in a penitentiary setting, without more, is not enough to satisfy the subjective component of cruel and unusual punishment. if plaintiff had shown or even alleged that defendants forced him to live with others who smoked and that they did so intentionally, knowing the smoke would have serious medical consequences for him, a different result might obtain. indeed, constant confinement under those conditions could be patently cruel. yet, defendants consistently made a reasonable effort to accommodate plaintiff's needs consistent with the conditions found in the institution.205 so, clemmons’s exposure to ets was not a sufficient medical need and there was no deliberate indifference to his exposure, and therefore he did not meet the necessary elements for an eighth amendment claim.206 however, his case provides a good example of an exposure cause brought as an eighth amendment claim. and the cases discussed above have stronger claims than clemmons’. 1. serious medical need courts have defined a serious medical need as “one that has been diagnosed by a physician as mandating treatment or one that is so obvious that even a lay person would easily recognize the necessity for a doctor's attention.”207 additionally, “whether a delay in treating the need worsens the condition” is another way of determining a serious medical need.208 “in either case, ‘the medical need must be one that, if left unattended, poses a substantial risk of serious harm.’”209 201. id. 202. id. (citing dace v. solem, 858 f.2d 385, 386-88 (8th cir. 1988)). 203. id. (citing french v. owens, 777 f.2d 1250, 1254 (7th cir. 1985)). 204. id. (citing aldridge v. montgomery, 753 f.2d 970, 972 (11th cir. 1985)). 205. id. at 1528. 206. id. at 1526. 207. hill v. dekalb reg'l youth det. ctr., 40 f.3d 1176, 1187 (11th cir. 1994). 208. id. at 1188-1189. 209. mann v. taser intern, inc., 588 f.3d 1291, 1307 (11th cir. 2009) (quoting farrow v. 250 indiana health law review [vol. 17:229 for example, a severe cataract that resulted in blindness in one eye was deemed to be a serious medical need.210 additionally, a delay in an inmate’s treatment for dentures was found to be a serious medical need because the evidence illustrated “pain, continual bleeding and swollen gums, two remaining teeth slicing into gums, weight loss, and such continuing medical problems.”211 here, continued exposure to toxins has led to serious medical needs. the inmates at sci fayette, for example, have serious medical needs for a variety of medical concerns ranging from lung infections to cysts and tumors in the nose, mouth, and throat, to gastrointestinal problems to skin conditions.212 while some of these conditions, like shortness of breath, may not be considered “serious” for purposes of an eighth amendment claims, others are sufficiently serious because a physician would mandate treatment for something as severe as a tumor, lung infection, or cancer. additionally, some of the conditions that may seem less serious now might worsen over time if left untreated, as the case with the dentures in farrow, which would constitute an eighth amendment violation.213 2. deliberate indifference the supreme court reasoned that “deliberate indifference” entails more than mere negligence in estelle v. gamble.214 the court clarified that a prison official “must both be aware of facts from which the inference could be drawn that a substantial risk of serious harm exists, and he must also draw the inference.”215 the eleventh circuit held “deliberate indifference has three components: (1) subjective knowledge of a risk of serious harm; (2) disregard of that risk; (3) by conduct that is more than mere negligence.”216 additionally, the eleventh circuit has also held that “an official acts with deliberate indifference when he knows that an inmate is in serious need of medical care, but he fails or refuses to obtain medical treatment for the inmate.”217 once again examining the situation at sci fayette, the guards may not have subjective knowledge of a particular inmates’ medical needs, however, the pennsylvania general assembly had subjective knowledge of the health risks posed at the site because when the dumping started at the site the residents of the nearby town of labelle began getting sick.218these residents reported respiratory west, 320 f.3d 1235, 1243 (11th cir. 2003)). 210. colwell v. bannister, 763 f.3d 1060, 1067 (9th cir. 2014). 211. farrow v. west, 320 f.3d 1235, 1244-45 (11th cir. 2003)). 212. mcdaniel, grote, fiorillo, cohen & cozzens, supra note 34, at 7-10. 213. farrow, 320 f.3d at 1244-45. 214. id. at 1245. 215. id. (quoting farmer v. brennan, 511 u.s. 825, 837 (1994)). 216. mcelligott v. foley, 182 f.3d 1248, 1255 (11th cir. 1999). 217. lancaster v. monroe county, 116 f.3d 1419, 1425 (11th cir. 1997). 218. bernd, mitra & loftus-farren, supra note 16. 2020] the death sentence that is america’s toxic prisons 251 problems, kidney failure, and cancers, and blamed the dumping site.219 however, construction on the prison continued “essentially putting the health of the entire prison population, as well its staff, at risk.”220 additionally, beyond the evidence in the local community of the risks from this particular coal ash dump, there are known health risks associated with living near these kinds of sites.221 “if eaten, drunk or inhaled, these toxicants can cause cancer and nervous system impacts such as cognitive deficits, developmental delays and behavioral problem. they can also cause heart damage, lung disease, respiratory distress, kidney disease, reproductive problems, gastrointestinal illness, birth defects, and impaired bone growth in children.”222 other health conditions that coal ash can cause include respiratory problems, hypertension, heart problems, brain and nervous system damage, liver damage, and stomach and intestinal ulcers.223 living near a coal ash disposal site can increase your risk of getting cancer and other diseases, according to the epa.224 so, instead of a particular guard having subjective knowledge of a serious harm posed to a particular inmate, this is actually a much more disturbing situation where the pennsylvania general assembly knew not only of the specific harm caused to a nearby town but also knew of the harms generally associated with the exposure to coal ash. therefore, there was subjective knowledge of the risk and the first element of the deliberate indifference analysis is met. what is more, they decided to build the prison anyway—they disregarded the risk of these serious health concerns by building the prison on the site.225 this meets the second element of the deliberate indifference analysis. additionally, this conduct was more than mere negligence—the third and final element of the deliberate indifference analysis.226 for the conduct to be more than mere negligence it would be reckless.227 reckless misconduct differs from negligence, in that negligence consists of mere inadvertence, incompetence, unskillfulness, or failure to take precautions; reckless misconduct, on the other hand, involves a conscious choice of a course of action, with knowledge or a reason to know that it will create serious danger to others. recklessness also differs in that it consists of intentionally doing an act with knowledge not only that it contains a risk of harm to others, as does negligence, but that it actually involves a risk substantially greater in magnitude than is necessary in the 219. id. 220. id. 221. coal ash: hazardous to human health, supra note 27. 222. id. 223. bernd, mitra & loftus-farren, supra note 16. 224. coal ash: hazardous to human health, supra note 27. 225. bernd, mitra & loftus-farren, supra note 16. 226. mcelligott v. foley, 182 f.3d 1248, 1255 (11th cir. 1999). 227. 57a am. jur. 2d negligence § 278 (2019). 252 indiana health law review [vol. 17:229 case of negligence.228 here, there was “a conscious choice of . . . action, with knowledge or a reason to know that it will create serious danger to others” because, as stated previously, the pennsylvania general assembly had reason to know that building the prison on the site would cause the adverse health effects already discussed.229 knowing about the health risks associated with exposure to coal ash and consciously choosing to build the prison on the site anyway is reckless and therefore meets the third element of the deliberate indifference analysis.230 3. causation between the defendant's indifference and the plaintiff's injury causation will be the most difficult element of the cruel and unusual punishment claim.231 in order to prove causation, there will need to be empirical studies done that prove the connection between the exposures and the harm suffered by inmates, as well as expert testimony that explain that connection.232 these are necessary aspects to prove causation and are beyond the scope and capability of this note. however, by examining causation in a toxic tort context, one can understand how the analysis under this element will likely unfold. in order for tortious conduct to be the cause of an injury, the “conduct must be the ‘factual cause’ of the physical harm to the plaintiff.”233 this is also known as the but-for cause; meaning the “harm would not have occurred absent the conduct.”234 the problem with factual causation in toxic torts is that it is difficult to prove the connection between the exposure to a substance and the development of a health effect, and the plaintiff must prove this connection by a preponderance of the evidence.235 this is different from the typical traumatic-injury tort case where, based on reasonable inferences, the defendant’s tortious conduct is the only potential cause of the injury.236 for example, in a car crash where a passenger breaks an arm, causes other than the accident are easily ruled out—reasonable inferences and experiences allow one to decide that a car crash is capable of 228. id. (footnotes omitted). 229. id. (footnote omitted). 230. mcelligott, 182 f.3d at 1255. 231. see restatement (third) of torts: liab. for physical & emotional harm § 28 (am. law inst. 2010). 232. see id. at cmt. c. 233. june v. union carbide corp., 577 f.3d. 1234, 1239 (10th cir. 2009) (quoting restatement (third) of torts: liability for physical & emotional harm §§ 26, 27 (2010)). 234. id. at 1240 (quoting restatement (third) of torts: liability for physical & emotional harm §§ 26 (2010)). 235. restatement (third) of torts: liability for physical & emotional harm § 28 cmt. c (2010). 236. id. 2020] the death sentence that is america’s toxic prisons 253 causing a broken arm.237 on the other hand, the causes of diseases are not as well understood.238 even known causes for certain diseases may explain only a fraction of the incidence of such diseases, with the remainder due to unknown causes. causal agents are often identified in group (epidemiologic) studies that reveal an increase in disease incidence among a group exposed to the agent as compared to a group not exposed. biological mechanisms for disease development—i.e., a series of causally linked physiological changes from exposure to disease development—are frequently complicated and difficult to observe. science continues to develop a better understanding of the biological steps in the development of diseases, but current knowledge in this respect is considerably more modest than for traumatic injury. as a consequence, courts in toxicsubstances cases often must assess various alternative methods proffered with regard to factual causation.239 because proving causation in toxic torts case is so specific regarding if exposure can cause disease, there is generally testimony from experts about why they believe an exposure could have or could not have caused disease.240 over the years, courts have varied in their standard for admissibility for expert testimony on this point because in some cases, experts differ on whether an exposure can be the cause of an injury.241 the restatement rejects any bright-line for this because “there are instances in which although one scientist or group of scientists comes to one conclusion about factual causation, they recognize that another group that comes to a contrary conclusion might still be ‘reasonable.’”242 however, the substantial factor test is an exception to a but-for cause.243 section 432 of the restatement (second of torts) states: “if two forces are actively operating, one because of the actor's negligence, the other not because of any misconduct on his part, and each of itself is sufficient to bring about harm to another, the actor's negligence may be found to be a substantial factor in bringing it about.”244 section 433 sets out considerations for “determining whether the actor's conduct is a substantial factor in bringing about harm to another.”245 those considerations are: (a) the number of other factors which contribute in producing the harm 237. id. 238. id. 239. id. 240. id. 241. id. 242. id. 243. june v. union carbide corp., 577 f.3d. 1234, 1240-41 (10th cir. 2009). 244. restatement (second) of torts § 432 (am. law inst.1965). 245. id. at § 433. 254 indiana health law review [vol. 17:229 and the extent of the effect which they have in producing it; (b) whether the actor's conduct has created a force or series of forces which are in continuous and active operation up to the time of the harm, or has created a situation harmless unless acted upon by other forces for which the actor is not responsible; (c) lapse of time.246 the court in june v. union carbide corp. explains how all these sections of the restatement interact with one another, stating, “[o]nce conduct satisfies one of the alternative requirements in § 432 . . . which in the restatement (third) . . . are the alternative grounds for being a factual cause—it must still qualify under § 433 if it is to be considered a substantial factor.”247 the substantial factor test is relevant here because, as with many toxic torts cases, there may be more than one factor or exposure that contributed to the inmates’ health problems.248 and, the exposure can still be the legal but-for cause of the health problems if it was a substantial factor in bringing about those health concerns.249 here, in the case of sci fayette, the exposure to coal ash was a substantial factor because the exposure itself was sufficient to bring about the harm to the inmates. the first consideration of section 433 of the restatement, is “the number of other factors which contribute in producing the harm and the extent of the effect which they have in producing it,” is difficult to discuss here because one does not know the other factors that might have contributed to a particular inmate’s condition.250 for example, if an inmate got lung cancer while at sci fayette, but also smoked a pack of cigarettes every day, that would be a factor to take into account under this consideration. without knowing more, one cannot get into this analysis at this time. however, the other two considerations are easier to analyze in this setting. the second consideration is “whether the actor's conduct has created a force or series of forces which are in continuous and active operation up to the time of the harm or has created a situation harmless unless acted upon by other forces for which the actor is not responsible.”251 here, the actor, the pennsylvania general assembly, created a force by building the facility next to the dumpsite.252 additionally, that force was in continuous and active operation up to the time of the harm, when the inmates got sick.253 the third consideration is “lapse of time.”254 the comments to section 433 explain that when there has been a long lapse of time it might diminish the effect 246. id. 247. june, 577 f.3d at 1240-41. 248. see generally restatement (second) of torts § 433b cmt. c (am. law inst. 1965). 249. id. § 431. 250. id. § 433. 251. id. 252. see bernd, mitra & loftus-farren, supra note 16. 253. id. 254. restatement (second) of torts § 433 (am. law inst. 1965). 2020] the death sentence that is america’s toxic prisons 255 of the actor’s conduct to where it becomes unsubstantial when compared to other contributing factors.255 however, the comments go on to state that “where it is evident that the influence of the actor's negligence is still a substantial factor, mere lapse of time, no matter how long, is not sufficient to prevent it from being the legal cause of the other's harm.”256 here, there was no lapse of time between the exposure and the harm because the inmates were being continuously exposed to the coal ash.257 the abolitionist law center and the human rights coalition’s twelve-month investigation into the health impacts of exposure to toxic coal waste on the inmates at sci fayette found startling health impacts among reporting prisoners, discussed above.258 the alarming statistics, however, are probably not enough to prove causation in court. the authors of the investigation seem to agree with this sentiment saying, “the inherent limitations of the survey do not establish this belief at an empirical level.”259 however, this feels like a strong basis in order to get more parties interested and invested in getting more studies done to prove causation in this case. when the choice was made to build prisons on toxic land those decisionmakers are deliberately indifferent to the serious medical needs that result from exposure to toxins. this is a form of cruel and unusual punishment and is therefore unconstitutional. iv. conclusion bringing these constitutional claims may be the wake-up call this country needs regarding the environmental injustices facing our inmate population. however, at its core, this is an attitude problem—a problem with having an indifferent attitude to the health and well-being of the inmates of this country. yet, the ways in which this indifference has manifested is unconstitutional, and going forward our country needs to either hold in the court or pass laws that prohibit these types of situations and protect our inmates’ constitutional rights. for example, the land on or near fci victorville, adx florence, and the northwest detention center are all built on or near superfund sites.260 the courts should hold or congress should pass a law that makes it illegal to build prisons on these sites because the government is forcing people to live on land with known serious health concerns associated with exposures from these sites. or, when there is a preferred alternative site, like at the northwest detention center, because of hazardous contamination on the other option, the hazardous option should be automatically taken out of the running because of the possible health 255. id. at cmt f. 256. id. 257. see bernd, mitra & loftus-farren, supra note 16. 258. mcdaniel, grote, fiorillo, cohen & cozzens, supra note 34. 259. id. at 2. 260. waters, supra note 46. 256 indiana health law review [vol. 17:229 problems that could arise from housing people there.261 indianapolis’ new criminal justice center presents an opportunity for the proper clean-up and safeguards to be in place before housing inmates on possibly toxic land and causing constitutional rights violations.262 forcing inmates to serve out their time in these toxic prisons is essentially a death sentence for those who never were condemned to such a harsh punishment and is unconstitutional on due process and cruel and unusual punishment grounds. however, this problem represents a bigger problem with how this country values those men and women trapped in our prison system and this country will need to reconsider the worth it puts on an inmate’s life. 261. immigration. & naturalization serv., supra note 53. 262. indianapolis breaks ground on robust new criminal justice center, supra note 103. something has to change: what can indiana do to save our babies? star s. meyer* i. introduction why does indiana have such a high infant mortality rate? what can healthcare providers and lawmakers do differently to decrease infant mortality rates in indiana? although the infant mortality rate in indiana is recognized as a serious problem, it remains high year after year.1 the indiana state department of health (“isdh”) recently announced that in 2018, indiana experienced its largest decrease in infant mortality rates in six years.2 however, despite multiple organizations providing resources to address infant mortality in indiana, we are not experiencing a sustained decrease in our rates. recent legislation requiring hospitals to implement perinatal standards of care, in an effort to obtain a certification from the state, also will not decrease infant mortality.3 once pregnancy begins, what often follows is a series of decisions that must be made in a system that can be difficult for anyone to navigate.4 whether you are a single teenager in high school, or a married professional, pregnancy can potentially launch women into a healthcare system of which they may have little knowledge or experience. regardless of the intended outcome of the pregnancy, one of the first decisions that must be made early on is choosing a healthcare provider.5 there are different options for women seeking prenatal care.6 when choosing a prenatal care provider, it is possible that the first thought many people have is an obstetrician-gynecologist (“ob-gyn”). however, there are other options including board certified family medicine physicians and certified nurse midwives (cnm).7 despite these different options, “[a]pproximately one-third * j.d. candidate, 2020, indiana university school of law – indianapolis; b.s.n., 2002, saint joseph’s college. 1. quality improvement comm., addressing infant mortality in indiana: a report to the ipqic governing council 4 (mar. 26, 2014), https://www.in.gov/isdh/files/ addressing_infant_mortality_in_indiana.pdf [https://perma.cc/2cc2-acu7]. 2. indiana infant mortality rate shows biggest decrease in 6 years, ind. st. dep’t health, https://calendar.in.gov/site/isdh/event/indiana-infant-mortality-rate-shows-biggestdecrease-in-6-years/ [https://perma.cc/2byv-qeta]. 3. program to certify perinatal levels of care designations for licensed hospitals and birthing centers that provides birthing services, ind. code ann. § 16-21-13-1 (lexisnexis 2019). 4. see office on women’s health, prenatal care and tests, u.s. dep’t health & human servs., https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-andtests [https://perma.cc/b5ts-ykes]. 5. see id. 6. id. 7. id. https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-andhttps://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-and292 indiana health law review [vol. 17:291 of indiana mothers (31.9%) do not receive prenatal care in their first trimester.”8 along with prenatal care, a pregnant woman must also decide where to deliver her baby and begin thinking about a plan for the birth.9 in deciding where to deliver a baby, the choice is often deciding among a hospital, birthing center, or home.10 when it comes to choosing between hospitals, the reality is that if you have already chosen a healthcare provider, there is not much of an option as to where the delivery will occur.11 healthcare providers are required to have privileges and to be credentialed in any hospital where they practice.12 if the healthcare provider does not have privileges at a certain hospital, then they cannot deliver babies there.13 additionally, many rural communities have limited access to hospital services.14 in fact, in indiana, fifty-two counties have less than two hospitals to choose from.15 of those fifty-two counties, twenty-five counties have no hospitals that provide maternity care.16 all of this, combined with insurance restrictions on in-network healthcare providers, means mothers do not necessarily have many options in deciding which hospital will deliver their baby. this is why it is puzzling that governor holcomb signed a new bill into law in 2018 that is supposed to decrease infant mortality.17 the purpose of the law, which went into effect on july 1, 2018, is to provide certifications of perinatal levels of care for hospitals and birthing centers.18 the rationale for the law is to assist new mothers in choosing which facility to deliver their baby.19 during news coverage on the new bill, governor holcomb stated, “[w]hen you think about the 623 babies that didn’t make it past their first year in the state of indiana, it’s clear that we have work to do.”20 the new law may be helpful for women in deciding 8. quality improvement comm., supra note 1, at 8. 9. office on women’s health, supra note 4. 10. id. 11. obstetric health care providers: choosing one right for you, cleveland clinic (apr. 26, 2017), https://my.clevelandclinic.org/health/articles/9698-obstetric-health-care-providerschoosing-one-right-for-you [https://perma.cc/4zc7-58kv]. 12. hospital governing board; responsibilities, ind. ann. code § 16-21-2-5 (lexisnexis 1999). 13. see id. 14. healthcare access in rural communities, rural health info. hub, https://www. ruralhealthinfo.org/topics/healthcare-access [https://perma.cc/bg8q-hzfy]. 15. march of dimes found., nowhere to go: maternity care deserts across the u.s. 2 (2018), https://www.marchofdimes.org/materials/nowhere_to_go_final.pdf [https://perma.cc/j8l7-b9gx]. 16. see id. at 4. 17. lauren chapman, holcomb signs bill to reduce infant mortality, standardize care, wfyi indianapolis (mar. 8, 2018), https://www.wfyi.org/news/articles/holcomb-signs-bill-toreduce-infant-mortality-standardize-care [https://perma.cc/8kys-tchc]. 18. id. 19. id. 20. id. https://my.clevelandclinic.org/health/articles/9698-obstetric-health-care-provide https://my.clevelandclinic.org/health/articles/9698-obstetric-health-care-provide 2020] something has to change: what can indiana do to save our babies? 293 whether to deliver their baby in a birthing center versus a hospital.21 however, almost 99% of deliveries in the united states occur in a hospital.22 because many women in indiana may not ultimately be choosing which hospital they will deliver their baby, we must question how this certification system would actually decrease infant mortality. a. the issue more must be done to decrease the infant mortality rate in indiana. as of december 2019, indiana has the seventh highest infant mortality rate in the country.23 at issue is the focus of indiana lawmakers in addressing infant mortality in the state. the new law, signed by governor holcomb effective july 1, 2018, implements a program to certify perinatal levels of care designations for licensed hospitals and birthing centers that provide birthing services.24 providing expectant mothers with information on the quality of care provided in the hospital in which they are going to deliver a baby will hopefully provide peace of mind. however, it is difficult to imagine how requiring hospitals to meet criteria for certifications will decrease infant mortality in indiana. the certification requirements are extremely complex and do not directly address the top causes of infant mortality.25 the long list of requirements to become certified as a level i-iv facility does not offer ways to decrease the risks of the top causes of infant mortality.26 the requirements also do nothing to address the problem of maternity care deserts.27 since this law will not solve the problem of infant mortality in indiana, lawmakers should look at what drives the infant mortality rate in indiana and address those specific issues. for example, especially in certain geographic locations, access to care specifically impacts infant mortality.28 lawmakers and 21. id. 22. marian f. macdorman et al., trends in out-of-hospital births in the united states, 1990–2012, nat’l ctr. for health stat. 1 (mar. 2014), https://www.cdc.gov/nchs/data/ databriefs/db144.pdf [https://perma.cc/mk64-59hv]. 23. infant mortality rates by state, ctrs. for disease control & prevention, https://www.cdc.gov/nchs/pressroom/sosmap/infant_mortality_rates/infant_mortality.htm [https://perma.cc/c4mr-brdb]. 24. program to certify perinatal levels of care designations for licensed hospitals and birthing centers that provides birthing services, ind. code ann. § 16-21-13-14 (lexisnexis 2019). 25. 410 ind. admin. code 39 (2019), https://www.in.gov/isdh/files/18-416%20-%20final% 20rule%202.pdf [https://perma.cc/n3w5-fkh8]. 26. see generally id. § 39-4-1. 27. id. 28. elaine cox, u.s. infant mortality: a case study in health care disparities, u.s. news & world rep. (may 23, 2016, 10:50 am), https://health.usnews.com/health-news/patientadvice/articles/2016-05-23/us-infant-mortality-a-case-study-in-health-care-disparities 294 indiana health law review [vol. 17:291 healthcare providers should also assess methods used in states with lower infant mortality rates and consider using the same approaches. the current indiana legislation will be ineffective in decreasing infant mortality rates. indiana needs to use an evidence-based and multi-disciplinary approach to address this very serious problem.29 b. roadmap this note discusses the consistently high infant mortality rate in indiana and the need for meaningful steps to decrease infant mortality in this state. section ii provides a background of infant mortality in the united states and in indiana. this section includes causes and risk factors of infant mortality. section ii also looks at maternity care deserts and what other states are doing to lower infant mortality rates or to maintain lower rates than indiana. section iii provides information on current indiana legislation that was signed into law in 2018. the purpose of the legislation is to decrease infant mortality, so a breakdown of the statute is provided in this section.30 this section will also describe why the current law will not work to decrease infant mortality. section iv discusses what organizations are doing, nationally and in indiana, to help decrease infant mortality rates. it also gives a detailed description of other steps that indiana could be taking to actually address risk factors and prevention of infant mortality, which would occur outside of the hospital setting. section v concludes the note by summarizing what indiana needs to do to lower infant mortality. this note analyzes the current situation and argues for a different approach to protect our babies. ii. background of the issue a. what is infant mortality? according to the centers for disease control and prevention (cdc), the definition of infant mortality is the death of an infant prior to his or her first birthday.31 the top five causes of infant mortality are: (1) birth defects, (2) preterm birth and low birth weight, (3) sudden infant death syndrome, (4) maternal complications, and (5) injuries.32 infant mortality caused by injuries includes suffocation.33 infant mortality is determined by calculating the number of infant deaths out [https://perma.cc/qu54-36d4]. 29. see infant mortality: what is cdc doing?, ctrs. for disease control & prevention, https://www.cdc.gov/reproductivehealth/maternalinfanthealth/infantmortalitycdcdoing.htm [https://perma.cc/g765-yucq]. 30. chapman, supra note 17. 31. infant mortality, ctrs. for disease control & prevention, https://www.cdc.gov/ reproductivehealth/maternalinfanthealth/infantmortality.htm [https://perma.cc/tbm7-uwc4]. 32. id. 33. id. 2020] something has to change: what can indiana do to save our babies? 295 of every 1,000 live births.34 as of december 2019, the infant mortality rate in the united states is 5.8 infant deaths per 1,000 live births.35 for that same time period, the infant mortality rate in indiana is significantly higher at 7.3 infant deaths per 1,000 live births.36 although there is no single cause of infant mortality, there are important factors to consider when addressing the issue. important factors during pregnancy that ultimately impact infant mortality rates include: starting folic acid, immunizations for the mother, smoking cessation, alcohol use during pregnancy, drug use during pregnancy, and maternal obesity.37 according to the indiana state department of health (isdh), “[a]s a risk factor, obesity is associated with preterm births (obese=25%, morbidly obese=33%). the negative health outcomes associated with preterm births can also be risk factors for mortality and include low/very low birth weights, respiratory distress, and feeding issues.”38 b. maternity care deserts like other areas in the country, many residents in indiana live in maternity care deserts.39 the march of dimes defines access to maternity care as, “availability of hospitals providing obstetric care, availability of providers offering obstetric care and access to that care through health insurance.”40 women who live in a maternity care desert live in a county that does not have obstetric providers or a hospital the providing obstetric care.41 nationwide, 1,085 counties are maternity care deserts.42 this equates to over five million women living in a maternity care desert in the united states.43 further, 150,000 babies are born to women living in maternity care desserts.44 in indiana, twenty-five counties are maternity care deserts.45 34. infant mortality rates by state, ctrs. for disease control & prevention, https://www.cdc.gov/nchs/pressroom/sosmap/infant_mortality_rates/infant_mortality.htm [https://perma.cc/e5th-ptzh]. 35. infant mortality, supra note 31. 36. infant mortality rates by state, supra note 34. 37. see march of dimes found., march of dimes foundation data book for policy makers: maternal, infant, and child health in the united states 44-50, (2016), https://www.marchofdimes.org/march-of-dimes-2016-databook.pdf [https://perma.cc/bt9767hh]. 38. quality improvement comm., supra note 1, at 8. 39. march of dimes found., supra note 15, at 2. 40. id. 41. id. 42. id. at 1. 43. id. 44. id. 45. id. at 2. 296 indiana health law review [vol. 17:291 healthy pregnancies start with early access to care.46 that care and support is extremely important for early identification and treatment of serious health conditions of mothers and babies.47 infants of mothers who live in maternity care deserts are at an increased risk of complications and death.48 it is essential that we address the problem of maternity care deserts in indiana. how can women access early prenatal care in an effort to decrease infant mortality if they do not have access to care in their community? the state should work with hospitals and healthcare providers to develop a solution for providing care to mothers and their babies. c. infant mortality in indiana indiana has historically had one of the highest infant mortality rates in the country.49 until 2018, infant mortality numbers were announced by the isdh, indiana’s infant mortality rate has been greater than 6.9 for over 100 years.50 there are likely many reasons that indiana’s infant mortality rate is high.51 one problem is that indiana has an extremely high smoking rate among pregnant women.52 in fact, the smoking rate is twice that of the national average with one in five pregnant women smoking in indiana.53 the quality improvement committee of the isdh points out that only eight states have a higher pregnancy smoking rate.54 this is important because of the negative impact that smoking has on infant mortality as a result of sudden unexpected infant death.55 in fact, a recent study showed that even smoking just one cigarette a day during pregnancy doubles the risk of sudden unexpected infant death.56 smoking is one example where addressing the problem with maternity care deserts could have a meaningful impact on infant mortality. it seems that early and consistent access to care would provide more of an opportunity for healthcare providers to screen patients for smoking and provide assistance in smoking cessation. however, without access to care, it would be more difficult to provide this assistance. work has been done in indiana in an effort to reduce infant mortality. in 2013, the isdh stated that it was making infant mortality, and focused efforts in 46. see id. at 10. 47. do you live in a maternity care desert?, march dimes found. (oct. 25, 2018, 11:28am), http://newsmomsneed.marchofdimes.org/?p=27523 [https://perma.cc/65jg-yt7w]. 48. id. 49. quality improvement comm., supra note 1, at 8. 50. id. 51. see id. at 9. 52. id. at 22. 53. id. at 8. 54. id. 55. tatiana m. anderson et al., maternal smoking before and during pregnancy and the risk of sudden unexpected infant death, 143 pediatrics 1, 4 (2019). 56. id. at 1. 2020] something has to change: what can indiana do to save our babies? 297 decreasing the infant mortality rate in indiana, its top priority.57 the isdh stated, “[i]nfant mortality reflects the health of a population at large and serves as a key indicator of a community’s health and care resources.”58 the isdh seemed to recognize that decreasing infant mortality can actually impact the overall health of indiana, which is one of the reasons that they chose to make this effort a priority.59 indiana held its first infant mortality summit in 2013.60 the governor at the time, mike pence, spoke at the summit.61 at that time, data from 2010 showed that indiana’s infant mortality rate was the seventh highest in the country.62 this summit was five years ago, and as of the publication of this note, indiana has the same ranking in infant mortality.63 in 2014, the quality improvement committee of the indiana perinatal quality improvement collaborative put together recommendations for decreasing indiana’s infant mortality rate.64 the report included: (1) a background overview of infant mortality in indiana and in the united states; (2) an assessment and explanation of the complexity of addressing this issue; (3) an assessment of the approaches by other states to decrease infant mortality that have been successful; (4) an explanation of indiana’s strengths and weaknesses in addressing this problem; (5) an explanation of how decreasing indiana’s infant mortality rate would benefit indiana; (6) an explanation of indiana’s current infant mortality rate and recommendations for improvement.65 despite this work and focused effort by the quality improvement committee, indiana’s infant mortality rate has not significantly decreased.66 as previously mentioned, indiana has a higher infant mortality rate than the national infant mortality rate. if indiana’s infant mortality rate was the same as the national rate, there would have been 118 fewer infant deaths in indiana in 2016.67 we must assess what other states are doing to accomplish significantly lower infant mortality rates than indiana. we must also specifically address the impact that smoking has on infant mortality in indiana. decreasing the smoking rate in indiana could decrease the risk of sudden unexpected infant death, which would impact our infant mortality rate. 57. quality improvement comm., supra note 1, at 4. 58. id. 59. see id. 60. id. at 7. 61. id. 62. id. 63. infant mortality rates by state, supra note 23. 64. quality improvement comm., supra note 1, at 4-5. 65. id. 66. infant mortality rates by state, supra note 23. 67. ind. state dep’t of health, infant mortality disparities 2016, (2016), https://www.in.gov/isdh/files/im%20disparities%202016.pdf [https://perma.cc/7m4h-79lp]. 298 indiana health law review [vol. 17:291 d. infant mortality throughout the united states indiana has an opportunity to learn from successes in other parts of the country. like the variance in infant mortality rates from county to county in indiana, there is a great deal of difference in infant mortality rates between the states.68 the geographic locations with the lowest infant mortality rates are on the east and west coasts with washington, oregon, california, new york, new jersey, vermont, new hampshire, massachusetts, and connecticut all having infant mortality rates below the national average.69 the states with the highest infant mortality rates are primarily in the south and include oklahoma, tennessee, georgia, delaware, louisiana, arkansas, mississippi, and alabama.70 indiana and ohio have the highest infant mortality rates in the midwest.71 while infant mortality rates have remained unchanged nationwide, california has experienced a 37% decrease from 1994-2015.72 a lot of the focus in california has been on the health and safety of pregnant women.73 california’s journey in decreasing infant mortality rates began with collecting data over a twenty year period and looking at what caused infant deaths in the state.74 a database was created by the california perinatal quality care collaborative and is where california hospitals could enter their data and compare themselves to other neonatal intensive care units (nicu) in the state.75 the data entered is related to infant deaths and complications and is paid for by the state of california.76 in reviewing the data in california, one specific hospital was able to see that it had a significantly higher rate of brain bleeds in infants in its nicu than other hospitals.77 understanding that intracranial hemorrhages are a leading cause of death in premature babies, this became actionable data when the hospital implemented evidence-based strategies to decrease brain bleeds in its nicu.78 the strategies included steroid shots for women in preterm labor, delayed umbilical cord clamping, and hospital wide training for staff on how to create a calm environment for premature infants in the hospital.79 the outcome was that 68. infant mortality rates by state, supra note 23. 69. id. 70. id. 71. id. 72. lucile packard found. for children, learn more about infant mortality, kidsdata.org, https://www.kidsdata.org/topic/294/infantmortality/table [https://perma.cc/3nem-cd3u]. 73. id. 74. anna almendrala, how california became the only state to lower its infant mortality rate, huffington post (aug. 9, 2018, 10:56pm), https://www.huffpost.com/entry/californiainfant-mortality-premature-babies_n_5b6b650de4b0bdd062062348 [https://perma.cc/4l3t-6xsz]. 75. id. 76. id. 77. id. 78. id. 79. id. 2020] something has to change: what can indiana do to save our babies? 299 within three years the hospital saw its rate of brain bleeds decrease from approximately 15% to 3.8%.80 the number of deaths in the nicu of that hospital decreased by almost half in that time.81 the doctors of the hospital credited the rapid improvement to having actionable real-time data that allowed interventions to be implemented quickly.82 maryland has an only slightly lower infant mortality rate than indiana at 6.4.83 however, areas in maryland have had some success stories that we could learn from. the b’more for healthy babies initiative is an approach used in baltimore.84 the program began in 2009 and uses public and private funding (a “collaborative funding model”).85 efforts in the program include: public education campaigns; home visits for pregnant women; and “collaborations with clinics and hospitals to make contraception more accessible.”86 the result of the program was that the infant mortality rate, in the area served, fell by 35%.87 other successes from the b’more for healthy babies initiative were that the disparity between african-american infant deaths and deaths of white infants decreased by 64%; teen birth rate decreased by 49%; and sleep related infant deaths decreased by 71%.88 another program in montgomery county in maryland has been working to reduce the disparity between african-american infant deaths and deaths of caucasian infants.89 the infant mortality rate in that area was only 4.8.90 however, the rate was 3.6 for caucasian county residents and 8.3 for african american county residents.91 montgomery county used a fetal infant mortality review board to actually determine the reasons for infant mortality. they then used this information to determine next steps and interventions.92 lawmakers in indiana can certainly evaluate the successes of other 80. id. 81. id. 82. id. 83. infant mortality rates by state, supra note 23. 84. using collective impact to reduce infant mortality in baltimore city, annie e. casey found. (june 22, 2018), https://www.aecf.org/blog/using-collective-impact-to-reduce-infantmortality-in -balt imore-city/?gclid=eaiaiqobchmisrt1v7ee3givhiszc h 3 q twveaayasaaegjyvfd_bwe [https://perma.cc/5n2c-qzve]. 85. id. 86. id. 87. id. 88. id. 89. laura jenkins, working to reduce infant mortality in maryland, wash. post (jan. 15, 2016), https://www.washingtonpost.com/opinions/working-to-reduce-infant-mortality-inmaryland/2016/01/14/027e078c-b310-11e5-9388-466021d971de_story.html?noredirect= on&utm_term=.3bb3c5a5e2c1 [https://perma.cc/6qqy-zmxy]. 90. id. 91. id. 92. id. 300 indiana health law review [vol. 17:291 communities and other states. in indiana, we should look at the success that a state like california has had in decreasing their infant mortality rates and determine if the same interventions can be used in indiana.93 like california, indiana has a perinatal quality improvement collaborative.94 however, not all collaboratives are the same.95 california’s was the first and it will take indiana time to build something similar.96 however, it is also important that the indiana perinatal quality improvement collaborative provide hospitals with assistance to actually implement improvement initiatives.97 simply providing education and resources will not make meaningful changes to infant mortality rates.98 certainly, requiring hospitals to spend money and resources to obtain a certification from the isdh will not make meaningful changes to infant mortality rates. we can also evaluate successes that smaller communities have had, such as b’more for healthy babies initiative, and try to implement those on a larger scale in indiana.99 fortunately, senate bill 278 passed in the indiana senate in february 2019.100 the bill became law on july 1, 2019, which means the isdh will assist with oversight of local fetal-infant mortality review teams.101 hopefully, like montgomery county in maryland, data collected from fetal-infant mortality review teams can be used to improve care and access to resources in communities in indiana. iii. legislation to improve infant mortality a. indiana legislation the current indiana legislation, which focuses on requiring hospitals to obtain certifications from the isdh, likely will not decrease infant mortality.102 for example, a healthy full-term pregnancy is an important factor in decreasing the risk of infant mortality.103 in order to decrease the risk of pre-term birth we must 93. lucile packard found. for children, supra note 72. 94. quality improvement comm., supra note 1, at 4. 95. almendrala, supra note 74. 96. id. 97. see id. 98. id. 99. using collective impact to reduce infant mortality in baltimore city, supra note 84. 100. leising: bill to address indiana’s high infant mortality rate passes senate, ind. senate republicans (feb. 5, 2019), https://www.indianasenaterepublicans.com/leising-bill-to-addressindiana-s-high-infant-mortality-rate-passes-senate [https://perma.cc/5vnm-7lfn]. 101. id. see generally fetal-infant mortality review teams, ind. code ann. § 16-49-6 (lexisnexis 2019). 102. program to certify perinatal levels of care designations for licensed hospitals and birthing centers that provides birthing services, ind. code ann. § 16-21-13-1 (lexisnexis 2019). 103. promoting health for infants, ctrs. for disease control & prevention, https://www. cdc.gov/chronicdisease/resources/publications/factsheets/infant-health.htm?cdc_aa_ refval=https%3a%2f%2fwww.cdc.gov%2fchronicdisease%2fresources%2fpublications%2f 2020] something has to change: what can indiana do to save our babies? 301 focus on interventions such as improving access to perinatal care and smoking cessation.104 however, the standards used to certify levels of care do not accomplish that.105 to understand the legislation, it is helpful to read the actual verbiage in the statute. ic § 16-21-13-1 states, “[t]he state department shall establish a program to certify perinatal levels of care designations for every hospital and birthing center licensed under this article that provides birthing services. (b)the program must include obstetrics level certification and neonatal level certification.”106 this section gives the isdh the authority to establish the levels of care for both the obstetrics and neonatal programs of hospitals and birthing centers. i.c. § 16-21-13-2 explains the authority of the isdh and states: the state department may do any of the following: (1) change the perinatal level of care designation for a hospital or birthing center if the state department determines that the hospital or birthing center failed to meet the standards necessary for the designated perinatal level of care. (2) investigate a complaint against a hospital or birthing center concerning a perinatal certification.107 ic § 16-21-13-3 provides explanation of licensed hospitals/birthing centers as well as duties and peer review.108 the statute specifically states: (a) a hospital or birthing center licensed under this article that offers birthing services may operate as a perinatal center if the hospital or birthing center complies with the perinatal certification requirements of the following: (1) the american academy of pediatrics. (2) the american college of obstetricians and gynecologists. (b) a perinatal center may perform peer review (as described in ic 34-30-15) for: (1) the perinatal center; (2) other hospitals; or (3) other birthing centers; that offer birthing services. this subsection does not prevent a perinatal center from performing its own peer review. (c) peer review performed by a perinatal center under this chapter must comply with ic 34-30-15.109 aag%2finfant-health.htm [https://perma.cc/86z5-knj7]. 104. see id. 105. see revised indiana perinatal hospital standards, ind. state dep’t of health 1, 4-27 (june 16, 2015), https://www.in.gov/laboroflove/files/revised_perinatal_hospital_ standards_6.15.pdf [https://perma.cc/4eem-bkxu]. 106. program to certify perinatal levels of care designations for licensed hospitals and birthing centers that provides birthing services, ind. code ann. § 16-21-13-1 (lexisnexis 2019). 107. authority of state department, ind. code ann. § 16-21-13-2 (lexisnexis 2019). 108. licensed hospitals or birthing centers; duties—peer review, ind. code ann. § 16-2113-3 (lexisnexis 2019). 109. id. 302 indiana health law review [vol. 17:291 b. perinatal hospital services levels of care to guide the work of the program of certifying perinatal levels of care, indiana has adopted the “revised perinatal hospital standards of 2015.”110 hospitals and birthing centers will be measured by six standards in obstetrics.111 there are also an additional five standards for neonatal and four standards for the entire facility.112 the first standard is organization and relates to the neonatalperinatal programs of the hospital.113 the second standard is obstetrical unit capabilities.114 obstetrical unit capabilities is the resources, supplies, and staffing available on the unit where deliveries will occur.115 the third is obstetric personnel and is related to the availability and roles of hospital personnel.116 this includes personnel such as obstetrics providers, anesthesia providers, radiologists, medical specialists, surgeons, and registered nurses (rn).117 the fourth standard is obstetric support personnel and is related to support services such as pharmacists, lactation consultants, social workers, rn case managers, blood bank technicians, and bereavement specialists.118 the fifth standard is obstetric equipment and includes such things as radiology equipment and resuscitation equipment and supplies.119 the sixth standard is obstetric medications and, in addition to requiring all resuscitation medications, it provides a list of medications that must be available to the obstetrics unit.120 the seventh standard is neonatal unit capabilities.121 the eighth standard is neonatal personnel and includes staffing requirements and the availability of certain consultants.122 the ninth standard is neonatal support personnel, which includes requirements for certain support staff such as radiology and blood bank.123 the tenth standard is neonatal equipment and the eleventh standard is neonatal medication.124 standard twelve is for laboratory requirements for obstetrics and neonatal.125 110. jon davis, indiana puts perinatal ‘levels of care’ standards into state law to reduce infant mortality, council st. gov’t (sept. 2018), https://www.csgmidwest.org/policyresearch/ 0918-perinatal-levels-of-care.aspx [https://perma.cc/bb4l-rv85]. 111. id. 112. revised indiana perinatal hospital standards, supra note 105, at 16-28. 113. id. at 2. 114. id. 115. id. 116. id. 117. id. at 8-11. 118. id. at 11-12. 119. id. at 12-13. 120. id. at 13-14. 121. id. at 16-17. 122. id. at 17-21. 123. id. at 21-22. 124. id. at 22-23. 125. id. at 24. 2020] something has to change: what can indiana do to save our babies? 303 standards thirteen through fifteen are education, performance improvement, and policies and protocols for the facility.126 within each standard is a set of written criteria and those criteria are used to assign the hospital or birthing center’s level of care certification.127 the levels of certification available are levels i – iv for obstetrics and neonatal.128 the revised indiana perinatal hospital standards provide a brief description of each level of certification under the obstetrical definitions and neonatal definitions.129 as you can see, the levels of certification are very specific and have complex requirements.130 however, the requirements within the standards for the levels of care do little to specifically address prevention of birth defects, preterm birth and low birth weight, sudden infant death syndrome, maternal complications, or injuries.131 if the standards do not address the top five causes of infant mortality, how could the requirements have a substantial impact on actually reducing infant mortality?132 instead of requiring hospitals to spend money and resources in meeting the requirements for the levels of certification, the state should partner with healthcare providers to decrease risk of infant mortality. it seems that the best way to decrease risk of infant mortality would be to focus on the causes of infant mortality and work to eliminate those causes as much as possible. lawmakers should also focus on the issue of maternity care deserts in this state.133 incentivizing providers and hospitals to expand services to underserved communities in indiana would provide an opportunity for early identification of risks for infant mortality.134 this would be a much more impactful use of resources than requiring existing hospitals that provide maternity care to obtain a certification by meeting standards that do not address the top risks of infant mortality. iv. more meaningful steps to decrease infant mortality in indiana the quality improvement committee for the isdh points out that there are a great deal of resources available to decrease infant mortality.135 however, we lack a coordinated effort in putting it all together to actually improve infant mortality rates.136 indiana needs to use an evidence-based and multi-disciplinary 126. id. at 24-28. 127. id. at 6, 9, 14, 17, 22, 26. 128. id. at 4-5. 129. see generally id. 130. see id. at 24-27. 131. see id. 132. infant mortality, supra note 31. 133. march of dimes found., supra note 15, at 10. 134. id. 135. quality improvement comm., supra note 1, at 4. 136. see id. 304 indiana health law review [vol. 17:291 approach to take steps in actually decreasing infant mortality. a. what non-profits are doing to address infant mortality other organizations within local communities have also been involved in the attempt to decrease infant mortality across the state. for example, indiana university health has invested in a safe and sound sleep program in an effort to achieve one of its primary goals of decreasing infant mortality in indiana.137 recognizing that the third leading cause of infant mortality in indiana is sleep related deaths, indiana university health hospitals send each baby home with a sleep sack and provide parents with education and tools for safe sleep.138 also, st. vincent hospital sends safe sleep bundles home with new parents.139 recognizing the importance of safe sleep in decreasing infant mortality, st. vincent is able to send parents home with a sleep sack, a pack-n-play with a sheet, and a safe sleep booklet.140 franciscan health made reducing infant mortality a system-wide community health goal in 2016.141 franciscan health states, “[f]rom mooresville to crawfordsville to hammond, programs are designed to help educate and empower parents. our programs provide education, supplies, counseling and resources to pregnant and new mothers through one-on-one interactions. participants report less stress, better bonding and confidence in their parenting abilities.”142 one example is the grace project in indianapolis, which helps mothers and babies recovering as a result of a mother’s substance abuse.143 another example is a program in lafayette for smoking cessation and breastfeeding support.144 community health network hosted an infant mortality summit in july 137. ind. u. health, safe and sound sleep, https://cdn.iuhealth.org/resources/09501010_community_impact_report_web_3.pdf?mtime=20180117141750 [https://perma.cc/6lmanbx3] 138. id. 139. 2018 associates campaign highlighted projects, ascension st. vincent found. (2018), https://give.stvincent.org/2018acprojects [https://perma.cc/9pvu-fh5t]. 140. id. 141. franciscan health, inspiring health: 2017 community benefit report 4 (2017), http://images.franciscanhealthcare.org/pdfs/enterprise/cbsa/community-benefit-report-2017.pdf [https://perma.cc/9v55-ylkz]. 142. id. 143. help precious babies have a better start to life through the grace project, franciscan health, https://www.franciscanhealth.org/news-and-events/news/help-preciousbabies-have-better-start-life-through-grace-project [https://perma.cc/7qdf-x7c5]. 144. tobacco cessation, franciscan health, https://www.franciscanhealth.org/health-careservices/tobacco-cessation-457 [https://perma.cc/de3t-4rhm]. lactation services, franciscan health, https://www.franciscanhealth.org/health-care-services/lactation-specialists-193 [https://perma.cc/e74z-kgmj]. 2020] something has to change: what can indiana do to save our babies? 305 2018.145 over 100 people attended and included representatives from community health network as well as “iu health, st. vincent health, eskenazi health, anthem indiana medicaid, the marion county public health department, the indiana house of representatives, the indiana senate, the minority health coalition, the march of dimes, the urban league, and indiana family and social services administration.”146 community health network’s website states, “[t]he four-hour event included the review of recent data regarding infant mortality rates; group discussions related to opportunities for improvement; and the development of action plans to promote positive change.”147 this summit is a great example of the collaborative work that needs to occur. it is excellent that members of the indiana house of representatives and the indiana senate were present.148 the question remains, however, what lawmakers will do to make meaningful improvement in infant mortality rates in indiana. the nurse-family partnership is a national organization and is a community health program.149 the program provides a visiting nurse to first time mothers who qualify, which begins during pregnancy and continues until the child turns two years old.150 the nurse-family partnership reports that their program results in an 18% decrease in preterm deliveries and a 21% increase in the number of newborns breastfed.151 the march of dimes foundation also does a great deal of work and has developed a data book for policy makers.152 the march of dimes foundation states, “[t]oday, the foundation works to improve the health of women, infants, children and families by preventing birth defects, premature birth and infant mortality through research, community services, education and advocacy.”153 a lot of great work and collaboration is already occurring, and the state should consider assisting with coordination of these efforts. assistance from the isdh on expanding efforts such as access to care, smoking cessation, breastfeeding support, and substance abuse recovery in our hospital systems would be a better use of resources than implementation of levels of certification. 145. press release, community health network, community health network hosts infant mortality summit (july 26, 2018), https://www.ecommunity.com/news/2018/community-healthnetwork-hosts-infant-mortality-summit [https://perma.cc/hsm8-8fe4]. 146. id. 147. id. 148. id. 149. nurse-family partnership overview, nurse-fam. partnership (2018), https://perma.cc/r8ep-csdc. 150. id. 151. nurse-fam. p’ship, nurse-family partnership continues to improve the health of our children (2017), https://www.nursefamilypartnership.org/wp-content/uploads/2017/ 02/2017-thorland-nfp-research-outcomes.pdf [https://perma.cc/ap7f-zjev]. 152. see generally march of dimes found., supra note 37. 153. id. at iii. 306 indiana health law review [vol. 17:291 b. what other professional organizations recommend professional organizations such as the american college of obstetricians and gynecologists and the american academy of pediatrics are also involved in the attempt to decrease infant mortality. support, research, and education from professional organizations can provide helpful insights from clinicians most involved and impacted by infant mortality. the american college of obstetricians participates in the fetal and infant mortality review.154 the american college of obstetricians website states, “fetal and infant mortality review (fimr) is a community-based and action-oriented process used to improve service systems and resources for women, infants[,] and families. this evidence-based method examines fetal and infant deaths, determines preventability, and engages communities to take action.” considering the recommendations of professional organizations might also be helpful for indiana in efforts to decrease infant mortality. c. reducing babies’ risk many organizations in indiana are doing a lot of important work to decrease infant mortality. however, a lot of that work is focused on safe sleep. although safe sleep is extremely important in decreasing a baby’s risk, there are other steps that we should be taking to make meaningful progress in decreasing infant mortality.155 it would be easier to decrease infant mortality if there were concrete ways to prevent those things that cause infant deaths, but that is not the case.156 however, work can be done to decrease the risks of the top causes of infant death.157 as previously mentioned, the top five causes of infant mortality are: (1) birth defects, (2) preterm birth and low birth weight, (3) sudden infant death syndrome, (4) maternal complications, and (5) injuries.158 it seems logical that addressing the risk factors for those top causes of infant mortality, especially for those people who experience higher infant mortality rates, would assist in decreasing infant mortality. 154. national fetal and infant mortality review (nfimr), am. c. obstetricians, https://perma.cc/ry9k-bgd3. 155. sudden unexpected infant death and sudden infant death syndrome, ctrs. for disease control & prevention, https://www.cdc.gov/sids/parents-caregivers.htm#additional [https://perma.cc/29xq-ae28]. 156. are there ways to reduce the risk of infant mortality?, eunice kennedy shriver nat’l inst. child health & human dev. (dec. 1, 2016), https://www.nichd.nih.gov/health/topics/ infant-mortality/topicinfo/reduce-risk [https://perma.cc/k23n-tlfv]. 157. id. 158. infant mortality, supra note 31. 2020] something has to change: what can indiana do to save our babies? 307 1. decreasing risk of birth defects. the leading cause of infant mortality in the united states is birth defects.159 birth defects can be structural or functional/developmental, and are present at birth.160 birth defects can cause a number of disabilities and health problems.161 the types of structural birth defects include: cleft lip and palate, heart defects, abnormal limbs, and neural tube defects.162 neural tube disorders involve problems with the brain and problems with the spine, such as spina bifida.163 the types of functional/developmental birth defects include: nervous system problems, brain problems, sensory problems, metabolic disorders, and degenerative disorders.164 the birth defect rate in the united states is one in every thirty-three births.165 risk factors for birth defects include: folic acid deficiency, alcohol consumption, smoking during pregnancy, drug use, certain medications, infections, obesity, diabetes, and environmental exposures.166 there are things that can be done to address these risk factors. for example, folic acid deficiency increases the risk of neural tube defects.167 because of this risk, the cdc recommend that pregnant women and women who plan to become pregnant consume 400 micrograms of folic acid each day.168 this level of folic acid can be found in vitamins that are sold over the counter at most pharmacies.169 unfortunately, however, only 40% of women who are of childbearing age are ingesting the recommended amount of folic acid.170 early access to perinatal care could be an opportunity to educate women on the amount of folic acid they should be ingesting to protect their babies.171 159. id. 160. birth defects, eunice kennedy shriver nat’l inst. child health & human dev., https://www.nichd.nih.gov/health/topics/birthdefects [https://perma.cc/62gq-esnh]. 161. id. 162. id. 163. id. 164. what are the types of birth defects?, eunice kennedy shriver nat’l inst. child health & human dev., https://www.nichd.nih.gov/health/topics/birthdefects/conditioninfo/types [https://perma.cc/h4ad-ukh7]. 165. birth defects, supra note 160. 166. what are the types of birth defects?, supra note 164. 167. how many people are affected by/at risk for birth defects?, eunice kennedy shriver nat’l inst. child health & human dev., https://www.nichd.nih.gov/health/topics/birthdefects/ conditioninfo/risk [https://perma.cc/n2qa-vqpv]. 168. id. 169. folic acid, ctrs. for disease control & prevention https://www.cdc.gov/ ncbddd/folicacid/about.html [https://perma.cc/23ab-mwee]. 170. how many people are affected by/at risk for birth defects?, supra note 167. 171. id. 308 indiana health law review [vol. 17:291 2. addressing the risks associated with preterm birth. preterm birth is the birth of a baby prior to the end of the thirty-seventh week of pregnancy.172 preterm births result in a higher risk of death and disability and approximately 10% of pregnancies result in preterm birth.173 although there are known risks for preterm birth, causes are often unknown and difficult to prevent.174 the cdc is collaborating with other organizations to address preterm births.175 the focus is on increasing awareness of preterm births in an effort to prevent preterm births and to address challenges faced by infants who are born preterm.176 because preterm births are often unexpected, prevention based on risk factors and the ability to address outcomes are important steps in decreasing the risk of infant mortality.177 3. addressing the risks associated with low birth weight. the cdc defines low birth weight as an infant weighing less than five and a half pounds immediately after birth.178 low birth weight can occur in infants born preterm and also in infants born at full term.179 low birth weight puts babies at higher risk for complications, including illness.180 the risk factors for low birth weight in infants include: smoking during pregnancy; alcohol consumption during pregnancy; history of preterm labor; maternal age of less than fifteen years old or more than thirty-five years old; environmental exposures (including lead in drinking water); and poor maternal weight gain during pregnancy.181 weight gain recommendations are based on a woman’s body mass index (bmi) before she became pregnant.182 approximately 21% of pregnant women are below the recommended weight gain for pregnancy.183 other risk factors for low birth 172. preterm birth, ctrs. for disease control & prevention, https://www.cdc. gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm [https://perma.cc/7e7z-wcve]. 173. id. 174. are there ways to reduce the risk of infant mortality?, supra note 156. 175. cdc preterm birth activities, ctrs. for disease control & prevention, https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermcdc-activities.html [https://perma.cc/4jgp-lv57]. 176. are there ways to reduce the risk of infant mortality?, supra note 156. 177. id. 178. reproductive and birth outcomes, ctrs. for disease control & prevention, https://ephtracking.cdc.gov/showrblbwgrowthretardationenv.action [https://perma.cc/58989gat] (last updated oct. 26, 2016). 179. are there ways to reduce the risk of infant mortality?, supra note 156. 180. reproductive and birth outcomes, supra note 178. 181. id. 182. see id. 183. weight gain during pregnancy, ctrs. for disease control & prevention, https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregnancy-weight-gain.htm [https://perma.cc/23sx-88uf]. 2020] something has to change: what can indiana do to save our babies? 309 weight are socioeconomic and include: income, education and marital status, stress, abuse, and domestic violence.184 addressing risks associated with low birth weight should involve a combination of screening, education, and support.185 for example, a pregnant woman who smokes will likely need assistance to stop smoking.186 like preterm birth, early and consistent access to prenatal care allows for identification of risk factors as well as treatment and support to decrease the risk of low birth weight.187 4. addressing the risks associated with sudden infant death syndrome and injuries. according to the centers for disease control and prevention, “[s]udden unexpected infant death (suid) is a term used to describe the sudden and unexpected death of a baby less than (one) year old in which the cause was not obvious before investigation.”188 although the risk of sudden infant death syndrome is unknown, through research, experts have been able to identify risk factors and recommendations for decreasing that risk.189 sudden infant death syndrome is a subcategory of sudden unexpected infant death, which also includes accidental suffocation while the baby is in a sleeping environment.190 as previously mentioned, infant mortality caused by injuries includes suffocation.191 one recommendation for decreasing the risk of sudden infant death syndrome and sudden unexpected infant death is related to educating pregnant mothers on the importance of refraining from smoking and using drugs and alcohol.192 this is another example of the importance of early and consistent access to prenatal care for identification of risk factors and education. in fact, one of the risk factors for sudden infant death syndrome is poor prenatal care.193 the cdc also recommends breastfeeding as a method of decreasing the risk of sudden infant death syndrome and sudden unexpected infant death.194 parents should also prevent their babies from being too warm.195 other steps in decreasing 184. reproductive and birth outcomes, supra note 178. 185. id. 186. id. 187. id. 188. about suid and sids, ctrs. for disease control & prevention, https://www.cdc. gov/sids/about/index.htm?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fsids%2fabo utsuidandsids.htm [https://perma.cc/xje3-9erk]. 189. sudden unexpected infant death and sudden infant death syndrome, supra note 155. 190. about suid and sids, supra note 188. 191. infant mortality, supra note 31. 192. about suid and sids, supra note 188. 193. id. 194. id. 195. id. 310 indiana health law review [vol. 17:291 the risk of sudden infant death syndrome and sudden unexpected infant death are related to safe sleep.196 these steps include: placing babies on their backs to sleep, avoiding loose bedding and soft surfaces, and only using safe cribs for sleep.197 the cdc also recommend regular doctor visits and vaccines for babies as well as use of a pacifier during sleep.198 5. addressing the risks associated with maternal complications. like other causes of infant mortality, maternal complications highlight the need for early and continuous access to prenatal care.199 however, it is also important for some women to have access to care before becoming pregnant.200 maternal complications specifically refer to pregnancy complications.201 maternal complications can occur before and during the actual pregnancy.202 possible maternal complications include: anemia, urinary tract infections, mental health conditions, high blood pressure, diabetes, obesity, infections, and severe nausea and vomiting.203 screening and care prior to becoming pregnant and early in pregnancy can help identify maternal complications for treatment.204 addressing all of the risk factors for infant mortality would be helpful in decreasing the infant mortality rate. according to the cdc, screening, treatment and education are common themes in addressing each of the infant mortality risks.205 for example, access to prenatal care can identify nutritional problems in mothers and decrease the risk of low birth weight.206 d. improve access to care the common theme in addressing the risk factors of infant mortality is the care, screening, and education associated with prenatal care.207 prenatal care is care received related to a pregnancy.208 in 2015 in indiana, one in eighteen babies 196. id. 197. id. 198. parents and caregivers, ctrs. for disease control & prevention, https://www.cdc. gov/sids/parents-caregivers.htm [https://perma.cc/2ymg-sllm]. 199. pregnancy complications, ctrs. for disease control & prevention, https://www. cdc.gov/reproductivehealth /maternalin fanthealth /pregnancy-complicat ions.h tml [https://perma.cc/75aq-5a7j]. 200. id. 201. infant mortality, supra note 31. 202. pregnancy complications, supra note 199. 203. id. 204. id. 205. pregnancy, ctrs. for disease control & prevention, https://www.cdc.gov/ pregnancy/during.html [https://perma.cc/6t7w-85kl]. 206. id. 207. see reproductive and birth outcomes, supra note 178. 208. quick facts: prenatal care, march dimes found., https://www.marchofdimes.org/ 2020] something has to change: what can indiana do to save our babies? 311 was delivered by a mother who received late or no prenatal care.209 adequate prenatal care includes monthly visits to your healthcare provider until week twenty-eight, bi-weekly visits from week twenty-eight through week thirty-six, and then weekly visits until childbirth.210 the frequency of prenatal care visits increases for women with high risk pregnancies.211 prenatal care also includes important screening, testing and education.212 part of the screening and education provided is related to smoking cessation, which is the most preventable cause of illness and death in infants.213 there are many resources emphasizing the importance of early prenatal care.214 however, it is unclear how indiana is expanding access to those women who do not seek any prenatal care. for example, what is the state doing to reach the mothers who live in the twenty-five counties in indiana that are maternity care deserts?215 another issue related to access to prenatal care is insurance coverage for that care. maternity care is one of the ten essential health benefits under the affordable care act.216 unfortunately, however, pregnancy is not a life qualifying event that allows enrollment or changes in plans outside of the once per year open enrollment period.217 also, if you have purchased a plan that existed on or before march 23, 2010, it is likely a grandfathered plan and is not required to provide maternity care.218 what is the state doing to provide prenatal care for mothers with no insurance coverage or insurance coverage that does not cover maternity care expenses? in 2015, indiana finally implemented a modified medicaid expansion, which was extremely important for access to prenatal care for indiana residents.219 however, with eligibility for pregnant women with household incomes up to 208% of the federal poverty level (fpl), what is peristats/viewtopic.aspx?reg=99&top=5&lev=0&slev=1 [https://perma.cc/7bfh-bj3f] 209. late/no prenatal care: indiana, 2007-2015, march dimes found., https://www. marchofdimes.org/peristats/viewsubtopic.aspx?reg=18&top=5&stop=25&lev=1&slev=4&obj=1. [https://perma.cc/r293-fpt4] 210. office on women’s health, supra note 4. 211. id. 212. id. 213. during pregnancy, ctrs. for disease control & prevention, https://www.cdc.gov/ pregnancy/during.html [https://perma.cc/d2y5-dfzs] 214. office on women’s health, supra note 4. 215. march of dimes found., supra note 15, at 2. 216. maternity insurance coverage, ehealth, https://www.ehealthinsurance.com/maternityinsurance-coverage [https://perma.cc/m6q5-qn6e] 217. id. 218. maternity insurance for pregnant women, am. pregnancy ass’n (dec. 12, 2017), https://americanpregnancy.org/planning/matern ity-insurance-for-pregnant-women/ [https://perma.cc/2a69-squ3] 219. indiana and the aca’s medicaid expansion, healthinsurance.org (mar. 27, 2018), https://www.healthinsurance.org/indiana-medicaid/ [https://perma.cc/3n4d-dksq] 312 indiana health law review [vol. 17:291 indiana doing to bridge the gap for women who do not qualify? 220 governor holcomb has stated that indiana will have the lowest infant mortality rate in the midwest by 2024.221 the indiana state health commission, dr. kristina box, acknowledges that access to prenatal care is important to healthy pregnancies and healthy babies.222 therefore, it is time for more action outside of hospital certifications and safe sleep practices.223 the state needs to actually partner with hospitals to provide outreach and access to prenatal care for indiana residents. v. conclusion when a woman becomes pregnant, one of the most important steps she will take will be obtaining early and consistent prenatal care. ideally, a woman will have access to care when she needs it. however, when access to care is limited in indiana, a hospital certification is unhelpful to expectant mothers who are seeking prenatal care. more important than hospital certifications, is early detection of factors increasing the risk of infant mortality as well as education and interventions to decrease those risks. current indiana legislation requiring certification of birthing centers and hospitals likely will not impact indiana’s infant mortality rate. indiana legislators need to take an evidence-based and multi-disciplinary approach to determine the best steps for addressing risk factors of infant mortality. access to care prior to pregnancy, during pregnancy, and after birth will impact infant mortality more than anything else. it is time for indiana to learn from states with lower infant mortality rates and take steps to provide that care to mothers and babies. instead of forcing hospitals to pour additional resources into obtaining an unhelpful certification status, we should be supporting healthcare organizations in expanding access to perinatal care. 220. id. 221. lindsay moore, state health commissioner talks infant mortality, family planning and abortion, j. & courier (apr. 26, 2019), https://www.jconline.com/story/news/2019/04/26/healthcommissioner-infant-mortality-family-planning-abortion/3495764002/ [https://perma.cc/2fmswapn]. 222. id. 223. id. indiana health law review volume xv 2018 number 1 note indiana’s public health is in jeopardy: lessons to learn from toxic chemical contamination in east chicago hannah reed * i. introduction life in government-subsidized housing is not always easy, especially for the residents of the west calumet housing complex (wchc) in east chicago, indiana. the wchc is a 346-unit public housing complex that was built atop the former u.s. smelter and lead refinery and was first occupied in 1973. post-1 industrialism and racially disparate housing patterns collided in this high-risk region to create a devastating public health crisis. for akeesha daniels, who moved with her children to the complex in 2004, the sinister secret of what lie within the soil was the difference between sickness and health. from living at the2 wchc, daniels’ two toddlers became sick with scarlet fever, a disease that has not been common since the 1950s, and struggled with health problems over the next ten years. when daniels voiced her concerns about conditions at the wchc3 to the east chicago housing authority (echa), they did not take daniels seriously and questioned whether she was keeping her unit clean enough. in the4 summer of 2016, daniels received letters from the environmental protection agency (epa) and the mayor of east chicago, informing her of the toxic chemical contamination in the housing complex’s soil and that residents would be “temporarily” relocated due to the public health risk. after receiving the5 letters, daniels and other residents of the complex were worried for their health and had many questions, such as who was going to pay for the move, where the * j.d. candidate, 2018, indiana university robert h. mckinney school of law; b.a. sociology 2015, purdue university. 1. west calumet – east chicago housing authority relocation plan 3, e. chi. hous. auth., http://echa-in.org/drupal/drupal-7.26/sites/default/files/wcal%20echa% 20relocation%20plan%20final%201-10-17.pdf [https://perma.cc/94nb-fm2f]. 2. alex zilenski, an indiana city is poised to become the next flint, thinkprogress (aug. 15, 2016, 12:33 pm) https://thinkprogress.org/40-years-in-the-dark-public-housing-residents-havebeen-living-on-toxic-soil-for-decades-4c6c3927edba#.9t27y18ex [https://perma.cc/5gtz-7y76]. 3. id. 4. id. 5. id. http://doi.org/10.18060/3911.0045 110 indiana health law review [vol. 15:109 residents would be moved to, and why residents were not informed of the serious health risk sooner.6 a. the issue the condition of the environment impacts public health in numerous ways.7 chemical contaminants such as lead are present in nearly all aspects of the environment; additionally, lead is reasonably anticipated to be a human carcinogen, meaning that exposure in high levels can affect the function of the body.. the majority of lead exposure is caused by human actions such as8 manufacturing. lead, arsenic, and other toxic chemicals are a threat to public9 health and the environment, especially when the chemical contaminants are not cleaned up properly and left to linger for several decades. lead poses a serious10 threat to public health when people are not aware of its existence in their surroundings, such as the soil where their home is located. the residential leadbased paint hazard reduction act defines lead-contaminated soil as “bare soil on residential real property that contains lead at or in excess of the levels determined to be hazardous to human health by the appropriate federal agency.”11 lead poisoning disproportionately affects low-income people and minorities, and even low-levels of lead poisoning can adversely affect public health, especially the health of children.12 studies indicate that lead in indiana’s soil from past and current industry use has substantially affected the lead levels in children’s blood. in fact, soil in13 indiana’s urban regions, like east chicago, contains up to twice as much the natural amount of lead in the soil found in rural areas throughout the state.14 unfortunately, significant legislative action has not yet been taken to address lead contamination problems in indiana and protect vulnerable communities throughout the state. 15 this note will argue that few viable remedies are available to predominately 6. id. 7. see lauri harvey keagle, health concerns at center of ec lead, arsenic cleanup, nw. ind. times (sept. 4, 2014), http://www.nwitimes.com/news/local/lake/east-chicago/healthconcerns-at-center-of-ec-lead-arsenic-cleanup/article_bbf6467a-e346-56fd-ac137a8948e0aa33.html [https://perma.cc/7xcl-bgj8]. 8. toxic substances portal: lead, agency for toxic substances & disease registry, https://www.atsdr.cdc.gov/substances/toxsubstance.asp?toxid=22 [https://perma.cc/s4s6-w4ju]. 9. id. 10. keagle, supra note 7. 11. residential lead-based paint hazard reduction act of 1992 § 1004(17), 42 u.s.c.a. § 4851b(17) (1992). 12. 42 u.s.c.a. § 4851(1), (2) (1992). 13. carlton m. waterhouse & ravay smith, the lingering life of lead pollution: an environmental justice challenge for indiana, 49 ind. l. rev. 99, 100-01 (2015). 14. id. at 103. 15. id. at 110. https://doi.org/10.18060/4806.0063 2018] indiana’s public health is in jeopardy 111 poor, urban communities affected by lead contamination, focusing on the recent lead contamination crisis faced by the wchc in east chicago, indiana. although many environmental laws are now in place to address contamination issues and protect public health in heavily industrialized communities, the laws have neither been adequate nor effective to prevent wchc residents from living in heavily poisonous community. lastly, this note will analyze past and current response mechanisms to toxic chemical contamination crises affecting public health and will recommend more appropriate and effective ways to respond, should another one arise in the future. in the end, this note will suggest education, preventative action, and interdisciplinary efforts are required to keep people safe from instances of toxic chemical contamination. b. roadmap this note discusses the recent revelation of heavily contaminated soil underneath the wchc in east chicago, indiana in july of 2016. in order to provide some background and analogy of the problem, section ii discusses the highly-publicized lead-contamination scandal in flint, michigan that preceded the scandal in east chicago, and looks at the existing factors in east chicago that likely lead to the contamination beneath the wchc. section iii analyzes the problem and the government’s response from a legal and sociological perspective, as well as past attempts to solve issues of environmental contamination and disparate impact. section iv examines legal liability for responsible parties, including federal, state and local agencies and polluters. section v outlines potential causes of action for victims of toxic chemical contamination with commentary on the likelihood of success for each cause of action. finally, section vi concludes with a call to action and a realization that changes must be made at the local, state, and federal level to ensure a timely and comprehensive response occurs should another toxic environmental contamination crisis arise. ii. background of the problem a. flint, michigan: indiana’s troubled neighbor one may easily draw comparisons between 2014’s lead contamination disaster of water pipes in flint, michigan and the lead-contaminated soil in east chicago, indiana, which is 252 miles southwest of flint. both cities are historic industrial towns with majority-black populations and a high percentage of people living in poverty. both cities have also had public health crises involving lead,16 which can cause health problems such as learning disabilities, mental retardation, and behavioral problems. 17 in flint, government officials sought to save money by switching the city’s water supply from the detroit water and sewerage department to the flint river 16. quick facts, u.s. census bureau, https://www.census.gov/quickfacts/table/ pst045216/2629000,1819486,00 [https://perma.cc/4437-wy5y]. 17. zilenski, supra note 2. 112 indiana health law review [vol. 15:109 in april 2014. however, the water drawn from lead pipes without corrosion-18 control poisoned residents in the post-industrial city and caused a widespread public health crisis. while many residents and businesses in flint noticed that19 the water was contaminated soon after the switch was made, the city government did not issue a lead advisory to residents until september 2015, and the epa did not issue an emergency order to take action until january 2016. after the flint20 crisis drew national attention for the government’s failure to respond in a timely manner, the east chicago crisis in indiana came under close scrutiny because the city also falls within epa region 5. the fact that east chicago falls under the21 same epa region as flint is significant because, should another environmental health crisis arise (as it did this time in indiana), the same officials within the same federal agency will handle the issue. therefore, because cities can learn from the mistakes made by responders in other cities with similar demographics and problems, government officials in east chicago may learn what to do, as well as what not to do, if they heed the lessons on protecting public health taught by the flint water crisis. b. east chicago, indiana: the crisis arises 1. industrious past with the events of the flint water crisis still making national news headlines, another highly publicized toxic chemical contamination made local and national headlines with the recent public revelation of heavily contaminated soil beneath the low-income wchc in east chicago. like flint, east chicago is a highly22 industrialized town that has been known to use toxic chemicals in the production of steel, petroleum, cement, lead, zinc, aluminum, and tin. lake county, which23 encompasses east chicago in indiana’s northwest region, is also home to one of the state’s most concentrated populations with, or at risk of, lead poisoning.24 deadly chemicals, such as lead and arsenic, were produced by a lead refinery and lead smelter and deposited in the soil long before the wchc was built on the same site in the 1970s. 25 18. merrit kennedy, lead-laced water in flint: a step-by-step look at the makings of a crisis, npr (apr. 20, 2016, 6:39 pm) http://www.npr.org/sections/thetwoway/2016/04/20/465545378/lead-laced-water-in-flint-a-step-by-step-look-at-the-makings-of-acrisis [https://perma.cc/zu3m-csyq]. 19. id. 20. id. 21. about epa: epa region 5, u.s. envtl. prot. agency, https://www.epa.gov/aboutepa/ epa-region-5 [https://perma.cc/tb9j-3wqu]. 22. david rutter, generations paid for east chicago’s pollution, indifference, chi. trib. (aug. 2, 2016, 12:12 pm) http://www.chicagotribune.com/suburbs/post-tribune/opinion/ct-ptbrutter-eclead-st-0803-20160802-story.html [https://perma.cc/22yr-swjp]. 23. zilenski, supra note 2. 24. waterhouse & smith, supra note 13, at 111. 25. rutter, supra note 22. 2018] indiana’s public health is in jeopardy 113 while the epa had been monitoring lead in the soil since west calumet’s designation as a superfund site, recent testing revealed soil contamination levels26 above the acceptable threshold. by 2014, the indiana department of27 environmental management (idem), the epa, and the department of justice (doj) negotiated cleanup settlements with the corporate polluters. however,28 residents of the wchc were not notified of the health risk in the soil beneath their homes until two years later in the summer of 2016. notice came in the29 form of letters from the epa and the mayor of east chicago, telling residents they would be relocated due to toxic contamination and risk to public health. in30 fact, the “extent of the contamination came as a shock to residents of the complex, even though it is just north of a former lead smelting plant and on top of a smaller former smelting operation, in an area that was designated as a superfund site in 2009.” in 2010,31 the echa conducted a physical needs assessment and discovered that the majority of housing units at the wchc had reached the end of their useful life and that repairs to the units would be too costly. residents of the wchc were not formally informed of the echa’s32 decision to remove residents until august 3, 2016, and echa’s relocation plan33 was not submitted to the department of housing and urban development (hud) for approval until september 2016. however, according to the initial relocation34 plan, residents were still required to pay rent up until november 1, 2016, and any residents remaining at the complex past march 31, 2017 were required to resume paying rent. as of october 2017, all residents of the wchc had moved out, and35 26. west calumet housing complex – east chicago, ind., u.s. envtl. prot. agency (last updated oct. 25, 2017), https://www.epa.gov/uss-lead-superfund-site/west-calumet-housingcomplex-east-chicago-ind [https://perma.cc/v3rr-tpt7]. 27. west calumet – east chicago housing authority relocation plan, e. chi. hous. auth., (last updated nov. 17, 2016) http://echa-in.org/drupal/drupal-7.26/sites/default/files/wcal% 20echa%20relocation%20plan%20final%201-10-17.pdf [https://perma.cc/94nb-fm2f]. 28. zilenski, supra note 2. 29. id. 30. id. 31. abby goodnough, their soil toxic, 1,100 indiana residents scramble to find new homes, n.y. times (aug. 30, 2016), http://www.nytimes.com/2016/08/31/us/lead-contaminationpublic-housing-east-chicago-indiana.html?hp&action=click&pgtype=homepage&clicksource= story-heading&module=first-column-region&region=top-news&wt.nav=top-news&_r=1 [https://perma.cc/xt68-ednp]. 32. west calumet – east chicago housing authority relocation plan, supra note 27, at 3. 33. id. 34. lauren cross, east chicago’s lead crisis: questions, concerns raised about east chicago housing authority relocation plan, nw. ind. times (sept. 25, 2016). http://www.nwitimes.com/news/local/lake/questions-concerns-raised-about-east-chicago-housingauthori ty-relocation-plan/art icle_dbc02f33-7c76-53f1-b34f-ed0009d729ef.html [https://perma.cc/42b8-77e4]. 35. west calumet – east chicago housing authority relocation plan, supra note 27, at 10. 114 indiana health law review [vol. 15:109 hud and the echa decided to demolish the tainted apartment complex.36 2. superfund designation a superfund site is any land in the united states that has been contaminated by hazardous waste and identified by the epa as a candidate for cleanup because it poses a risk to human health and the environment. superfund sites, such as the37 wchc, typically consist of abandoned plots of land that have been heavily contaminated in the past, perhaps by businesses that are no longer in operation.38 superfunds were created in 1980 by the comprehensive environmental response, compensation, and liability act (cercla), which imposed a tax on certain polluting industries to provide funding for government actions in response to toxic releases or abandoned hazardous waste sites. arsenic and lead, two39 materials found in the soil at the wchc superfund site, are ranked first and second on cercla’s priority list of hazardous substances. the epa40 acknowledged that “[l]ead contamination at superfund sites presents a threat to human health and the environment . . . [that] can be harmful to humans (particularly children) when ingested or inhaled.” despite the harmful41 contaminants that exist at many superfund sites, there is no time limit within which industry owners or potentially responsible parties must complete superfund site cleanup. cleanup at some superfund sites may even last several42 decades. 43 in 2009, the site beneath the wchc was listed on the national priorities list of the worst contaminated superfund sites in the country with lead and arsenic as the primary contaminants of concern. since july 2016, tests have shown that44 hundreds of children living in the housing complex have dangerously high levels of lead in their blood. while the wchc’s location atop a superfund site was45 36. west calumet housing complex – east chicago, ind., supra note 26. 37. what is a superfund site?, u.s. envtl. prot. agency (last visited oct. 18, 2017), https://superfund.zendesk.com/hc/en-us/articles/211634808-what-is-a-superfund-site[https://perma.cc/xb8m-92d4]. see generally comprehensive environmental response, compensation, and liability act of 1980, 42 u.s.c.a. §§ 9601-9675. 38. id. 39. id. 40. priority list of hazardous substances, agency for toxic substances & disease registry (last updated sept. 25, 2017), https://www.atsdr.cdc.gov/spl/#modalidstring_ mytable2015 [https://perma.cc/efu6-r66k]. 41. lead at superfund sites, u.s. envtl. prot. agency (last updated may 26, 2017), https://www.epa.gov/superfund/lead-superfund-sites [https://perma.cc/5hu6-zj5c]. 42. how much time does an industry owner of a superfund site have to clean the site up? u.s. envtl. prot. agency (last visited oct. 18, 2017), https://superfund.zendesk.com/hc/enus/articles/211635188-how-much-time-does-an-industry-owner-of-a-superfund-site-have-to-cleanthe-site-up[https://perma.cc/k2rf-wqa7]. 43. id. 44. uss lead superfund site, u.s. envtl. prot. agency (last updated jan. 10, 2018), https://www.epa.gov/uss-lead-superfund-site?id=0501433 [https://perma.cc/8w98-nss8]. 45. goodnough, supra note 31. 2018] indiana’s public health is in jeopardy 115 not a secret, one must ask why the echa continued to lease apartments to tenants at a location deemed one of the worst contaminated sites in the country for seven years after the wchc’s superfund designation and national priorities listing in 2009. as of july 2016, east chicago wanted to relocate 1,200 residents,46 including 600 children, living in the wchc projects, but many residents were unsure of where else to go due to lack of money and few comparable low-income housing units available in east chicago. while east chicago officials47 distributed housing vouchers and relocation counseling to wchc residents, this solution was not effective. some residents felt that the echa dodged questions48 and offered vouchers in lieu of answers, while other residents who received vouchers still could not afford to pay a new security deposit to landlords.49 3. ineffective local solutions despite the voucher system, relocating affected wchc residents outside east chicago may not solve the housing issue for various reasons, including the residents’ reluctance to uproot their lives and the lack of comparable housing in the immediate area. research conducted in late 2016 indicated that all of the50 families residing at the wchc are unlikely to find housing options within the echa’s jurisdiction, which adds to the struggle of finding comparable housing that adequately meets the residents’ needs. other issues that may discourage51 affected wchc residents from leaving east chicago are family members living nearby and the potential for gang violence in surrounding cities. additionally,52 geographic immobility may plague low-income residents who may not able to afford a personal car, and who may rely on public transit to get to and from work. reliance on public transit may limit where a person can live and travel. residents of the wchc will likely face housing struggles whether they remain in east chicago or leave. c. questions to consider consider the relationship between federal, state, and local officials. public health disasters often arise from a failure of government or as a consequence of poor policy choices at all levels. a system of overlapping and shared53 responsibility among federal, state, and local governments is often required.54 ideally, each tier of government should play a unique role in a well-coordinated 46. zilenski, supra note 2. 47. rutter, supra note 22. 48. west calumet – east chicago housing authority relocation plan, supra note 27, at 4. 49. goodnough, supra note 31. 50. id. 51. west calumet – east chicago housing authority relocation plan, supra note 27, at 11. 52. zilenski, supra note 2. 53. lawrence o. gostin & lindsay f. wiley, public health law: power, duty, restraint 76 (3rd ed. 2016). 54. id. 116 indiana health law review [vol. 15:109 effort to ensure the health and safety of all citizens. unfortunately, it seems that55 the government agencies involved in the east chicago lead contamination crisis left the public in the dark about the public health and environmental issues around them. government agencies should be, and could have been, more cohesive in56 reacting to this environmental health crisis. determining which entity had knowledge of the environmental contamination and resulting health crisis, and which one had the most resources to address the problem are important to think about in determining who should be held responsible. identifying the responsible party and what remedies are available can streamline the compensation and remediation process should another toxic environmental crisis arise in the future. iii. analysis of the problem a. threats to public health science has proven that toxic chemical exposure leads to illness, disease, and negatively affects mental processes. as wchc residents found out at a57 community meeting, “children [if exposed to lead at a young age] can be left with severe brain damage, resulting in irreversible mental disorders, seizures, behavioral disorders like adhd, and stunted educational growth.” lead does58 not linger in the blood for long before being absorbed by bones and organs.59 thus, the damage of lead poisoning is irreversible and side effects will linger for the rest of an exposed person’s life. a 2008 study found that children with high60 levels of lead in their blood end up with significant decreased brain volume as adults, indicating lead’s adverse effect on brain development and its alteration of the brain’s structure. lead affects the brain’s gray matter, a region which is61 responsible for executive functions, mood regulation, and decision-making.62 alteration to such crucial factors of the brain are significant because an affected child may have trouble with fine motor skills and may develop abnormal social behavior, such as aggression. other studies have found that this brain alteration,63 abnormal social behavior, and aggression can be linked with higher violent crime 55. id. 56. goodnough, supra note 31. 57. zilenski, supra note 2. 58. id. 59. abby goodnough & diantha parker, the facts about lead exposure and its irreversible damage, n.y. times (jan. 29, 2016) https://www.nytimes.com/2016/01/30/us/lead-poisoning.html [https://perma.cc/jjv4-umgb]. 60. id. 61. kim m. cecil, et al, decreased brain volume in adults with childhood lead exposure, plos med. (may 27, 2008) http://journals.plos.org/plosmedicine/article?id=10.1371/journal. pmed.0050112 [https://perma.cc/fc6m-xz2t]. 62. id. 63. id. https://doi.org/10.1371/journal.pmed.0050112 2018] indiana’s public health is in jeopardy 117 rates. 64 because lead affects the body’s nervous system and cognitive development, childhood lead poisoning may also result in problems such as lower i.q., hearing loss, reduced attention span, learning disabilities, and perhaps death. early65 childhood educators often see the aforementioned mental and physical effects of lead poisoning on child development. the areas affected by lead poisoning will66 also pose negative consequences for children throughout their years in school, and may set them up for a lifetime of failure. since the harm caused by lead poisoning is irreversible, the implications of lead poisoning on vulnerable young children should have been enough to spur the echa, idem, the epa, and state and local governments into action. while lead and other toxic chemicals pose health risks to all individuals who are exposed to them, recent headlines of the events in flint and east chicago have prompted government agencies to act to preserve public health and safety of vulnerable populations, such as children, whose “bodies absorb lead more quickly and efficiently than adults.” to combat permanent health problems suffered by67 children who are exposed to lead, the centers for disease control and prevention (cdc) implemented a childhood lead prevention program to protect this vulnerable population. the cdc partnered with hud and the epa, as well as68 other agencies, to eliminate lead poisoning in children by the year 2020 in a plan called healthy people 2020. 69 although the healthy people 2020 plan is targeted at lead poisoning stemming from house-related hazards – like lead paint – perhaps several of its measures can be aimed at tackling lead poisoning from other sources near or surrounding the home, such as soil. the healthy people 2020 federal strategy to eliminate childhood lead poisoning as a public health problem includes measures such as identification and care for children with elevated blood levels, surveillance of elevated blood levels in children to monitor progress, and research to further improve childhood lead poisoning prevention methods. a central goal70 of this plan is to eliminate elevated blood lead levels in children, especially in 64. kevin drum, lead: america’s real criminal element, mother jones (feb. 11, 2016) http://www.motherjones.com/environment/2016/02/lead-exposure-gasoline-crime-increasechildren-health [https://perma.cc/5kat-7usp]. 65. marco beltran, impact of lead exposure in very young children, admin. for children & families, https://www.acf.hhs.gov/blog/2016/03/impact-of-lead-exposure-in-veryyoung-children-0 [https://perma.cc/fd6v-cc2v]. 66. id. 67. id. 68. cdc’s childhood lead poisoning prevention program, healthypeople.gov, https://www.healthypeople.gov/2020/prevention-portal-508/initiative/cdcs-childhood-leadpoisoning-prevention-program [https://perma.cc/xga3-shtb]. 69. cdc’s childhood lead poisoning prevention program, ctrs. for disease control and prevention, https://www.cdc.gov/nceh/lead/about/program.htm [https://perma.cc/u3n38wq6] (last updated feb. 9, 2015). 70. id. 118 indiana health law review [vol. 15:109 low-income housing where young children live. hundreds of children residing71 at the wchc could have benefitted from this plan had the toxic soil contamination crisis been publicized in time to prevent damage. if the epa can learn from its past mistakes and failed initiatives, it may find success in forming a multi-agency partnership with the cdc and hud to prevent lead poisoning resulting from lead exposures. b. negative social effects children who are at the highest risk for lead exposure are often low income, members of racial or ethnic minority groups, recent immigrants, have parents who are exposed to lead at work, or live in older, poorly maintained rental properties or areas with outdated plumbing. the children of the wchc fall into at least72 three of the aforementioned categories: low income, member of racial or ethnic minority groups, and live in older or poorly maintained rental properties. while73 racial and socioeconomic barriers to health are difficult to transgress, the variable that can be the most easily remedied is the type of housing in which the children live. however, low-income individuals of racial or ethnic minority groups have limited choices in where they can live due to the prevalence of environmental racism and housing discrimination.74 environmental racism signifies “any policy, practice, or directive that differentially affects or disadvantages (whether intended or unintended) individuals, groups, or communities based on race or color.” this kind of racism75 is often reinforced through legal or governmental means, and is targeted toward people of color, working class people, and poor people. the residents of the76 wchc have historically been poor racial minorities who, due to their indigent status, may struggle to obtain adequate healthcare, hire a lawyer to file a lawsuit, or find suitable alternate housing. 77 in 2010, the epa promised to make environmental justice a priority of the agency, alongside air and water quality and chemical safety. the epa defines78 environmental justice as “the fair and meaningful involvement of all people regardless of race, color, national origin, or income, with respect to the 71. eliminating childhood lead poisoning: a federal strategy targeting lead paint hazards, president’s task force on envtl. health risks and safety risks to children (feb. 2000), https://www.cdc.gov/nceh/lead/about/fedstrategy2000.pdf [https://perma.cc/e9yv9r78]. 72. beltran, supra note 65. 73. id. 74. see robert d. bullard, essays on environmental justice: environmental racism and “invisible” communities, 96 w. va l. rev. 1037, 1038 (1994). 75. id. at 1037. 76. id. 77. zilenski, supra note 2. 78. david m. konisky, environmental justice delayed: failed promises, hope for the future, 58 envtl. just. 2, 4 (march/april 2016). 2018] indiana’s public health is in jeopardy 119 development, implementation, and enforcement of environmental laws, regulations, and policies.” when everyone has “the same degree of protection79 from environmental and health hazards, and equal access to the decision-making process to have a healthy environment in which to live, learn, and work,”80 environmental justice can be achieved. environmental justice “involves issues and concerns around . . . lead poisoning . . . unequal protection, differential exposures, and unequal enforcement of environmental, public health, civil rights, and housing laws.”81 the existence of lead in the soil at the wchc in east chicago is an environmental justice issue because the residents were disproportionally exposed to a toxic environmental and health hazard based on the government housing resources available to them. the epa has even labeled the wchc as an82 environmental justice community due to the residents’ unequal degree of protection from environmental health hazards in their home. however, this83 “health emergency . . . is a window into a larger environmental justice crisis playing out in neighborhoods across the country.” because the residents of the84 wchc have suffered from lead-contaminated soil in their yards, the epa did not meet its goal of providing equal protection from environmental and health hazards. distributive justice is the equitable distribution of environmental burdens and benefits. ideally, all groups of people (e.g. poor, wealthy, minority, white)85 would receive equal protection under the law from environmental health hazards and receive equal treatment (e.g. response time, cleanup efforts) in the event of an environmental health disaster. however, the “less politically powerful a community, and the lower the land values, the more likely it is that polluting industry will be sited in that community.” as a result, distributive justice does86 not seem to be the case in east chicago because as a poor community made up of mostly minorities, the city and the wchc seem to bear disproportionate burdens of environmental health hazards. procedural justice has to do with the87 79. environmental justice, u.s. envtl. prot. agency, https://www.epa.gov/ environmentaljustice [https://perma.cc/7dvq-zrra]. 80. id. 81. bullard, supra note 74, at 1041. 82. see brian eason, chelsea schneider, & maureen groppe, east chicago lead pollution ‘a potential catastrophe’, indianapolis star (aug. 22, 2016, 8:50 pm), http://www.indystar.com/story/news/2016/08/22/east-chicago-lead-pollution-potentialcatastrophe/89112984/ [https://perma.cc/qdh8-ls86]. 83. atlantic richfield: faces suit over arsenic poisoning, 18 class action rep. (nov. 14, 2016) lexisnexis legal news. 84. zilenski, supra note 2. 85. konisky, supra note 78, at 7. 86. elizabeth b. forsyth, solving widespread toxic chemical exposure: a taxing job, 29 va. envtl. l. j. 115, 122. (2011). 87. see rutter, supra note 22. 120 indiana health law review [vol. 15:109 fairness and transparency of decision-making processes. questions addressed88 by procedural justice include who makes the siting decisions for chemical polluters and for government-subsidized housing, and whether residents of government-subsidized housing know about environmental health hazards that may be affecting their lives. in the case of the wchc, the environmental contamination and resulting health hazards beneath the feet of residents remained ignored until july 2016 because the government failed to act. in turn, the89 wchc residents had little decision-making power regarding environmental issues that posed a threat to their health and the health of their families. the story of akeesha daniels being “brushed off” by echa authorities and reprimanded for “not cleaning well enough” when she confronted them with her concerns is90 a procedural justice issue because she was turned away by the very authority that should have been protecting her. corrective justice refers to the degree of fairness with which punishments are levied for violations of environmental and public health laws, and how government agencies use legal tools to prevent and redress disparities. the main91 chemical polluters in east chicago today, dupont and atlantic richfield, reached a $26 million cleanup agreement in 2014 with the state of indiana, the epa, and the doj to pay for remediation of the affected properties. however, this92 “penalty” outlined in the agreement pales in comparison to the $1 billion profit dupont made in 2015, and therefore does not represent much of a penalty at all.93 in fact, the city of east chicago has reported to the state that it needs an estimated $56 million for cleanup costs associated with the lead contamination crisis. nevertheless, the polluters can still be held accountable for their pollution94 and may be found civilly liable for claims by the affected residents.95 social justice “emphasizes the roles of individuals and social arrangements as causes of environmental problems” and notes that environmental disparities are part of a larger scheme, including race and socioeconomic status that perpetuates social inequality. discriminatory housing practices on the basis of race, color,96 national origin, or familial status fall into the social justice category. social97 justice applies to the residents of the wchc because hud filed a formal complaint on behalf of the residents against the echa for discriminatory housing 88. konisky, supra note 78. 89. zilenski, supra note 2. 90. id. 91. konisky, supra note 78, at 7. 92. rutter, supra note 22. 93. id. 94. nick janzen, east chicago estimates $56 million needed for lead cleanup, wfyi indianapolis (mar. 10, 2017), http://www.wfyi.org/news/articles/east-chicago-estimates-56million-needed-for-lead-cleanup [https://perma.cc/xe5g-wcfz]. 95. see infra section iv. 96. konisky, supra note 78, at 7. 97. id. 2018] indiana’s public health is in jeopardy 121 practices under federal law. the complaint alleged that the echa discriminated98 against residents in its relocation efforts by attempting to relocate them into “poor, segregated communities with similar or serious levels of environmental contaminations.” 99 the wchc is but one of many low-income communities that face issues of unequal protection when it comes to the environment and health, and is but one population for whom the consequences of environmental hazards and contamination have long been ignored. environmental racism, along with100 unequal enforcement of laws, places communities of color at risk. african101 american children are roughly three times more likely to suffer from lead poisoning than caucasian children in families with similar income. majority-102 white communities also tend to see more proactive governmental action, faster results, and stiffer penalties against violators of the law than do minority communities. this vulnerable population has clearly fallen through the cracks103 and not received the protection they deserve from their government. environmental protection from serious health hazards should be afforded to all communities in a non-discriminatory way. c. the government’s response government failure to act in response to environmental health crises that affect poor urban communities is not new. federal studies done in the 1980s found evidence of lead poisoning in children living in a predominately black west dallas, texas neighborhood where residue from a lead smelting factory was dumped. although the dallas health department knew of these findings, no104 action was taken to prevent future illnesses. although many officials among105 differing levels of government were involved, the public likely expected government officials to fulfill their duty of communication and candor to the public. the people of east chicago certainly deserved communication and candor, as well. while the epa set up yard signs at the wchc in east chicago telling residents not to play in the contaminated dirt in august 2016, this warning came too late and did nothing to correct the damage that had already occurred to public 98. opinion letter on preliminary voluntary compliance agreement and title viii conciliation agreement, u.s. dep’t of hous. & urban dev. (sept. 7, 2016), http://echain .o rg /d rupal /d rupal-7 .26/s i tes /defau l t / f i les /execu ted%20vca%20effected% 20nov%202%202016.pdf [https://perma.cc/p9dg-rw8a]. 99. id. 100. zilenski, supra note 2. 101. bullard, supra note 74, at 1044. 102. id. at 1042. 103. id. at 1045. 104. id. at 1043. 105. id. 122 indiana health law review [vol. 15:109 health, the residents themselves, and the environment. throughout august106 2016, the epa spread mulch in yards and playground areas as a “temporary barrier” to keep contaminated dirt from being tracked into homes. the epa107 claimed these efforts were “part of a larger effort to clean up the u.s.s. lead superfund site.” the december 2016 site update for east chicago states that108 from august 2016 through the first week of november, epa officials “surveyed homes [at the wchc] to get access agreements to conduct indoor sampling; sampled around 270 homes to determine indoor lead levels; [and] temporarily relocated about 270 households to hotels and cleaned their homes.” thirty-109 seven residents declined the epa’s offer to have their homes and furniture cleaned, and the remaining units in the complex were vacant. as of early 2017,110 the epa announced it had shut down most sampling and cleanup activities in the residential areas of the wchc for the end of 2016, and planned to continue sampling and cleanup in the spring of 2017. by late 2017, the epa announced111 it was accepting public comments on a sixty-million-dollar increase in its cost for cleanup of the wchc site.112 unfortunately, several experts have “consistently and repeatedly concluded” that the government and epa’s efforts to redress environmental health hazards have fallen short of expectations. in fact, as of early 2017, there is no mention113 on the epa’s website of compensating the victims for their lead exposure or struggles to find adequate housing. while the echa’s west calumet114 relocation plan provided that residents may appeal to the echa for any disputes related to the housing relocation or the housing choice voucher program, no cause of action or other source of compensation stemming from the lead exposure was mentioned. only time will tell if the epa’s remedial measures of spreading115 mulch and cleaning the inside of homes in the wchc will prove effective. rather than relying wholly on the epa, indiana law delegates responsibility for lead poisoning programming to local government agencies. however, state116 government agencies may not be efficiently coordinated in their efforts to combat wide-reaching public health problems. some east chicago residents hoped for more consistency in federal lead regulation as a result of the flint crisis, but that did not occur. when residents of east chicago reached out to the state for help,117 106. rutter, supra note 22. 107. west calumet housing complex – east chicago, ind., supra note 26. 108. id. 109. id. 110. id. 111. uss lead superfund site, supra note 44. 112. id. 113. konisky, supra note 78, at 9. 114. uss lead superfund site, supra note 44 (discussing cleanup activities and progress but not financial compensation for victims). 115. west calumet – east chicago housing authority relocation plan, supra note 27, at 16. 116. ind. code ann. §§16-41-39.4-1 to -9 (west 2016). 117. zilenski, supra note 2. 2018] indiana’s public health is in jeopardy 123 idem responded “the epa was ‘the lead agency with the authority and responsibility for this site.’” the epa then stated that their delayed notification118 to the residents of the unsafe lead levels in the soil on “problems with the contractor the agency hired to tabulate the data and concerns about the data’s quality.”119 media coverage of past environmental and housing disasters, like in flint, likely affected the government’s response to east chicago lead contamination crisis. the national attention garnered by the water contamination crisis in120 flint, michigan may have ignited action for other contaminated communities like east chicago. if flint had not happened, the east chicago crisis may have121 continued to be ignored. d. past attempts to correct health risks from environmental contamination for decades, the law has struggled to right the wrongs of environmental contamination and its disparate impact. some legal and policy solutions that have been passed to prevent and address lead poisoning will be discussed below. 1. legal solutions congress enacted cercla in 1980 to address serious environmental and health risks caused by industrial pollution. a probable failure of cercla’s122 effectiveness in the past is that it is complex, complicated, and leaves the ultimate responsibility for cleanup to a large, overburdened government agency. on the state level, indiana has the benefit of drawing from the hazardous substances trust fund, which maintains a source of money collected from punitive damage awards or violations of indiana environmental law. the trust fund pays123 expenses related to the release of hazardous substances and contaminants where no responsible party can be found and invests money into an environmental remediation fund. as seen in east chicago, contaminated communities may get124 lost in the bureaucratic shuffle while waiting for much-needed aid from the epa, which allows harm to continue for longer than necessary. one may argue both sides of whether this was a bureaucratic or monetary decision. it may be argued that placement of low income housing on the site of a dangerous superfund site was both monetary and bureaucratic. the city may have wanted to save money by sacrificing the health of people living in the environmental justice community, and the decision to place low-income housing there was a simple and easy one to make. 125 the residential lead-based paint hazard reduction act (rlphra) of 1992 118. goodnough, supra note 31. 119. id. 120. zilenski, supra note 2. 121. id. 122. supra note 37. 123. ind. code ann. § 13-25-4-1(a)(9) (2014). 124. id. 125. bullard, supra note 74. 124 indiana health law review [vol. 15:109 addresses lead exposure resulting from the use of lead-based paint and household dust in public housing, as well as lead exposure through contaminated soil. the126 rlphra contains disclosure provisions that require the epa to regulate disclosure of lead-based paint hazards in homes for sale or lease by providing the purchaser or lessee with lead hazard information and providing a lead hazard evaluation report about such housing. some actions for damages brought under127 this law were initially successful. unfortunately, this law does not allow for128 private rights of action under 42 u.s.c.a. § 1983, a law which is one potential legal remedy for wchc residents. this law should be interpreted more broadly129 by courts to more effectively meet its goal of reducing lead exposure, perhaps by allowing children affected by lead poisoning to bring actions or by permitting causes of action for violations of civil rights pursuant to 42 u.s.c. § 1983. while the rlphra expanded the definition of lead poisoning by including housing conditions that may cause harmful exposures, this law represents the extent of federal laws specifically addressing exposure to lead hazards in or around the home.130 in 1994, president clinton signed executive order 12898—federal actions to address environmental justice in minority populations and low-income populations—to direct federal agencies, such as the epa, to identify communities most at risk of environmental health hazards and address the disproportionately 126. residential lead-based paint hazard reduction act of 1992, 42 u.s.c.a. §§ 4851-4856 (1992). see supra notes 11, 12. 127. 42 u.s.c.a. § 4852d (1992). 128. minor children and their parents brought a class action against the housing authority of louisville (hal) seeking monetary and injunctive relief from violations of federal, state, and municipal codes to prevent and eliminate lead-based paint exposure in public housing. charges included negligence, gross negligence, outrage, fraudulent concealment, punitive damage, and breach of contract between hal and hud, based on covenants that hal properties were safe and in compliance with federal statutes for the prevention of lead-based paint exposure. the court found that the plaintiffs did not have standing to seek injunctive relief from hal because they did not have constitutional standing, or a personal stake, in requiring hal to take remedial action. the court found that the plaintiffs have constitutional standing to seek monetary relief from their damages, and the plaintiffs had prudential standing to seek damages under the rlphra. l.b. iii v. hous. auth. of louisville, 344 f. supp. 2d 1009 (w.d. ky. 2004). 129. see mair v. city of albany, new york, 303 f. supp. 2d 237, 243 (n.d. ny 2004) (finding that the statute supporting plaintiffs’ prayer for relief from the city of new york’s leadbased paint abatement activities did not meet the requirements of a § 1983 claim, which are congressional intent, showing by proponent that the right assertedly protected by statute is not vague and amorphous, and the statute impose a binding obligation on the states). see also l.b. iii v. hous. auth. of louisville, 345 f. supp. 2d 725 (w.d. ky. 2004) (holding in a subsequent decision that minor children had no cause of action based on the rlphra because they were neither purchasers nor lessees, and rlphra’s disclosure provisions did not create federal rights in residents of public housing properties that could be enforced pursuant to § 1983). see infra note 156 for more discussion of § 1983. 130. waterhouse & smith, supra note 13, at 109. 2018] indiana’s public health is in jeopardy 125 high adverse environmental or health effects of the agency’s actions on minority or low-income populations. in response to this executive order, an official from131 the epa confessed that the agency neglected to consistently integrate environmental justice into its daily operations, had not clearly defined the populations that the executive order was supposed to cover, and failed to develop criteria for determining disparate impacts. despite its idealistic aims,132 critical internal failures prevented this executive order from achieving its purpose and goals. analysts of this executive order have found that incorporation of environmental justice principles into protective programs has been rare. an133 additional failure of this executive order, alongside lack of implementation and failure to execute, was that it did not include state or local government officials and the affected populations in its plan to instill environmental injustice principles in solution-making. 134 2. policy solutions the epa developed plan ej 2014 as an agency roadmap to integrate environmental justice into programs, policies, and initiatives. this plan135 indicated that the “epa has taken serious strides to translate the principles and policy directives articulated in e.o. 12898 and other federal environmental justice pledges into a concrete and comprehensive strategy.” scholars questioned136 whether this plan would actually help the epa become more responsive to environmental justice concerns. ej 2014 provided the foundation for the ej137 2020 action agenda, which advanced the epa’s environmental justice agenda until the year 2020. through the ej 2020 action agenda, the epa wishes to138 integrate environmental justice ideals into its programs and partner with state and local governments, other federal agencies, and people in affected communities to correct environmental health hazards found in lead, drinking water, air quality, and hazardous waste sites. ej 2020 recognizes that low-income populations and139 underserved communities, such as the wchc, are most vulnerable to adverse health effects resulting from exposure to environmental contamination. this140 plan perhaps demonstrates a renewed commitment to implementing 131. laws and regulations: summary of executive order 12898 – federal actions to address environmental justice in minority populations and low-income populations, u.s. envtl. prot. agency, https://www.epa.gov/laws-regulations/summary-executive-order-12898-federal-actionsaddress-environmental-justice [https://perma.cc/t29e-tgwx]. 132. konisky, supra note 78, at 5. 133. id. at 9. 134. id. 135. id. 136. id. at 10. 137. id. at 6. 138. environmental justice: about ej 2020, u.s. envtl. prot. agency, https://www.epa.gov/environmentaljustice/ej-2020-action-agenda-epas-environmental-justicestrategy [https://perma.cc/7dvq-zrra]. 139. id. 140. id. 126 indiana health law review [vol. 15:109 environmental justice initiatives into the epa’s permitting, rule-making, and enforcement because these measures are important steps toward ensuring people in communities like the wchc receive the attention and care they deserve during times of environmental and public health crises. despite its proactive aims, perhaps the ej 2020 action plan inadvertently demonstrates the lack of care and concern shown to poor and at-risk communities in the past, despite numerous attempts at federal action to promote environmental justice initiatives. the epa still has a few years to achieve the goals outlined141 in the ej 2020 plan. the probability of these federal initiatives tricking down into state environmental agencies remains to be seen. hopefully the exposure of environmental health problems plaguing flint and east chicago will encourage agency administrators to stick to environmental justice initiatives and encourage full participation, something never before achieved. iv. legal liability a. liability for federal agencies the east chicago crisis was “a mind-numbing failure of government to hold polluters accountable.” the epa considers lead concentration of 400 parts per142 million (ppm) to be safe for residential use, concentrations higher than 400 ppm to warrant cleanup, and concentrations exceeding 1200 ppm to require emergency removal. in may 2016, the epa and hud provided updated lead levels to east143 chicago city officials that reached 91,100 ppm in some areas of the complex, an astonishingly high level which is 228 times greater than the epa’s maximumpermitted lead level of 400 ppm for residential areas. hud, along with other144 federal agencies, has a statutory duty to conduct research to develop improved methods for testing for lead in soil, establish appropriate cleanup standards, and evaluate the effectiveness of testing techniques. 145 judicial review of administrative action may hold federal agencies liable for inadequately addressing problems in comparison with legal standards.146 proposed legislation in congress, called the regulatory accountability act of 2017, amends the administrative procedure act of 1982, reforms the procedure by which federal agencies analyze and form new regulations and guidance, and clarifies the nature of judicial review of agency actions. the new act states that147 agencies should consider whether their actions have created or contributed to the 141. see konisky, supra note 78, at 5 (noting that the epa “has long been criticized for making empty pledges on environmental justice.”). 142. rutter, supra note 22. 143. cross, supra note 34. 144. zilenski, supra note 2. 145. 42 u.s.c.a. § 4854(a) (1992). 146. william h. timbers & david a. wirth, private rights of action and judicial review in federal environmental law, 70 cornell l. rev. 403, 407 (1985). 147. regulatory accountability act, h.r. 5, 115th cong. (2017); 5 u.s.c.a. § 701 ( 2011). 2018] indiana’s public health is in jeopardy 127 problem, and whether the agency’s rules or procedures could be amended to address the problem.148 many federal environmental laws expressly allow citizens to bring civil suits on behalf of themselves against any other person, federal agency, or the united states government. if a federal act does not expressly provide an enforcement149 mechanism, courts have interpreted the existence of implied private rights of action in many federal laws.150 however, the barrier of governmental immunities limits private rights of action against the federal government because the federal government has sovereign immunity and cannot be sued unless it waives its sovereign immunity or consents to suit. additionally, private right of action151 suits brought against governmental entities based on federal environmental laws have not been successful in the past. 152 b. liability for state agencies idem tested forty soil samples taken from the wchc in 2004. finding153 dangerous levels of lead and arsenic but faced with limited resources, idem turned the site over to the epa. idem’s act of turning over cleanup154 148. regulatory accountability act, h.r. 5, 115th cong. § 103 (2017). 149. timbers & wirth, supra note 146, at 405-06. see, e.g., toxic substances control act, 15 u.s.c.a. § 2619 (west 1982) (authorizing any person to commence a civil action against any person, including the united states or any other governmental agency in violation of the toxic substances control act). 150. timbers & wirth, supra note 146, at 406. see cort v. ash, 95 s. ct. 2080, 2088 (1975) (determining that an implied cause of action is to be discerned from relevant factors, such as the statute creating an especial benefit for a class of which the plaintiff is a member, legislative intent to create a remedy, the remedy is consistent with the underlying purpose of the legislative scheme, and whether the cause of action is traditionally relegated to state law so that it would be inappropriate to infer a cause of action based solely on federal law). see also transamerica mortg. advisors, inc. v. lewis, 100 s.ct. 242, 252 (1979) (finding that “[o]nce it is recognized that a statute creates an implied right of action, courts have wide discretion in fashioning available relief.”). 151. see price v. united states, 174 u.s. 373, 375-376 (1899) (noting that the government is not liable to suit unless it consents thereto). see also schillinger v. united states, 155 u.s. 163, 166 (1894) (finding that the united states cannot be sued in federal courts without its consent, and in consenting congress has discretion to specify the types of cases in which governmental liability may be brought before the courts). 152. timbers & wirth, supra note 146, at 406. see california v. sierra club, 451 u.s. 287, 295 (1981) (finding that congress was not concerned with the rights of individuals in the environmental law cited by petitioners, and “there is no ‘indication of legislative intent, explicit or implicit, either to create such a remedy or deny one.’”). see also middlesex cty. sewerage auth. v. nat’l sea clammers ass’n, 453 u.s. 1, 22 (1981) (finding that there was no implied right of action under the federal environmental laws). 153. rutter, supra note 22. 154. id. 128 indiana health law review [vol. 15:109 responsibility of the wchc property may have confused the community about which party was leading the cleanup efforts. companies acting without fair warning that their actions are valid under federal law, such as idem, are entitled to the presumptive validity and immunity from liability. while indiana law155 does not provide immunity from civil liability for an act or omission that constitutes gross negligence or willful or wanton misconduct, idem should156 not be allowed by law to shift the full burden onto the epa in an attempt to escape liability or discharge a duty to act. as a result of the toxic environmental contamination crisis at the wchc, a change should be made in the law to prevent state agencies such as idem from turning over a matter to the epa without expressly notifying affected victims or releasing knowledge of existing contamination. turning over a contaminated property is not the answer because it may prevent timely remediation, rehabilitation, and notification to the public. c. liability for local agencies the echa may have knowingly placed the wchc on top of a contaminated site that was known to contain toxic chemicals in the soil. if so, the echa may be subject to a civil rights claim by the affected residents. in fact, a resident of157 east chicago included a § 1983 claim in a lawsuit that she brought individually and on behalf of her children against the city, the echa, east chicago mayor anthony copeland, and polluters dupont and atlantic richfield. the lawsuit158 brought numerous claims against the defendants, including a violation of 42 u.s.c. § 1983, the 14th amendment, rights to due process and bodily integrity, contractually-created property rights in the wchc, conspiracy, personal injury, breach contract, breach of implied warranty of habitability, fraud and misrepresentation, and trespass. the lawsuit also alleged that when the159 polluters entered into a consent decree with the city of east chicago in 2014, residents should have been notified that an agreement to clean up the lead and arsenic contamination had been reached and in not being notified, federal, state, 155. wis. resources prot. council v. flambeau mining co., 727 f.3d 700, 708 (7th cir. 2013) (finding that although the polluting party’s permit was not valid under epa regulations, the permit was presumptively valid because it relied on the state epa administrator’s directions). 156. ind. code ann. § 34-30-6-2(2) (west 2016). 157. any person who subjects or causes to be subjected the deprivation of privileges and immunities secured by the constitution or other laws shall be liable to the injured party in an action by law, suit in equity, or other proper proceeding for redress. 42 u.s.c.a. § 1983 (1996). see maine v. thilboutot, 448 u.s. 1, 4 (1980) (holding that a plaintiff can sue under § 1983 for violations of federal law in addition to violations of constitutional rights). see also blessing v. freestone, 520 u.s. 329, 340 (1997) (holding that only violations of federal rights, not mere violations of federal statutes, will give rise to a § 1983 action). 158. walker v. city of e. chi., no. 2:16 cv 367, 2017 u.s. dist. lexis 160729 (n.d. ind sept. 29, 2017) (lexis, indiana resident: city, makers of lead paint liable for contamination, injuries, 25:11 mealey’s emerging toxic torts 12 (2016)). 159. id. 2018] indiana’s public health is in jeopardy 129 and local authorities condoned wrongdoing and maliciously exposed wchc residents to harmful contaminants through their wrongdoing. 160 in the echa’s act of not providing timely replacement housing to affected residents of the wchc and siting federally-assisted housing atop contaminated land, the echa is likely liable for a disparate impact claim under the civil rights act of 1964. this act provides “[n]o person in the united states shall, on the161 ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal assistance.” 162 d. liability for polluters environmental risk disparities often result from discriminatory decisions, made intentionally or unintentionally, by private actors. civil liability for163 violations of environmental law is strict. nevertheless, it is still difficult to hold164 industrial polluters accountable, especially when the initial polluters are no longer in operation. a solution to this issue is the legal theory of successor in interest, which provides a way for victims to recover from businesses that are no longer solvent or in operation by holding the defunct business’ successors or assigns liable so long as the ownership of a business is carried on and controlled substantially as it was before the transfer. under the theory of successor in interest, atlantic165 richfield and dupont are liable based on their connection to operators of the plants that produced and released lead and arsenic contaminants in the affected wchc location. 166 an additional road to remediation of the wchc land is through a consent decree between government authorities and the polluting party. the united states filed a complaint under cercla of 1980 on behalf of the epa, idem, and the state of indiana to recover past cleanup costs incurred by the epa, doj, and the 160. id. 161. see villanueva v. carere, 85 f.3d 481, 486 (10th cir. 1996) (finding that certain regulations promulgated pursuant to title vi of the civil rights act prohibit actions that have a disparate impact on protected groups, even in the absence of discriminatory intent). see also guardians ass’n v. civil serv. comm’n of n.y.c., 103 s.ct. 3221, 3235 (1983) (holding that proof of discriminatory intent is not required to establish a violation of the civil rights act, but unless discriminatory intent is shown, declaratory and injunctive relief should be the only available remedies). 162. civil rights act of 1964, 42 u.s.c.a. § 2000d (west 1964). see supra note 76 (noting that the residents of the west calumet housing complex were predominantly minorities). 163. konisky, supra note 78, at 13. 164. see, e.g., clean water act, 33 u.s.c.a. § 1319. see also kelly v. u.s. epa, 203 f.3d 519, 522 (7th cir. 2000) (holding that civil liability under the clean water act is strict, and good faith or lack of knowledge is not a defense). 165. successor in interest, black’s law dictionary (10th ed. 2014). 166. keagle, supra note 7. 130 indiana health law review [vol. 15:109 state in responding to the u.s.s. lead superfund site and requested the performance of response actions by atlantic richfield and dupont. the167 primary objective of the consent decree, drafted in 2014, is to protect the public health and welfare or the environment by designing and implementing cleanup and response actions by atlantic richfield and dupont. the consent decree168 binds atlantic richfield, dupont, and their successors and assigns to ensure that any change in ownership of the contaminated property where the wchc currently stands would not change the terms of the consent decree. the terms169 of the consent decree also require the polluters to submit monthly progress reports and release report to the epa and the state of indiana, and post a $21 million surety bond with the epa as a performance guarantee. in the interest of170 transparency, these reports from polluters also should have been available or easily accessible to affected wchc residents. however, despite the consent decree, indiana law provides for immunity for a person who implements or completes an approved response action, such as a consent decree, from claims concerning matters addressed in the response action.171 thus, additional claims field against the polluters with subject matter already covered by the consent decree may not succeed in indiana courts. if a consent decree with a polluting party is not successful, the epa’s superfund enforcement program comes into play under the authority of cercla. the epa begins enforcement and monitoring of superfund cleanup172 by identifying potentially responsible parties and asking them to perform cleanup before using superfund money. if the responsible polluting party does not173 agree to cleanup, the enforcement program works to bring the contaminating party into compliance with an order or settlement, such as a consent decree.174 the epa may issue an order compelling the parties to clean up the site, assess penalties, take over the work themselves, or partner with the doj to file a civil complaint against the responsible party in federal court. the superfund175 enforcement program exempts state and local governments from liability for costs resulting from emergency response to a hazardous substance release and offers 167. consent decree at 1, u.s. v. atl. richfield co. & e. i. dupont de nemours and co. (n.d. ind. 2014) (no. 2:14-cv-312), https://semspub.epa.gov/work/05/919701.pdf [https://perma.cc/c9jd-96mw]. 168. id. at 10. 169. id. at 1. 170. see also id. at 14, 17. 171. ind. code ann. § 13-25-4-27(b) (west 2016). see also ind. code ann. § 34-30-2-51.6 (west 2016). 172. s u p e r f u n d e n f o r c e m e n t , u . s . e n v t l . p r o t . a g e n c y , https://www.epa.gov/enforcement/superfund-enforcement [https://perma.cc/6d6k-mh84]. see generally comprehensive environmental response, compensation, and liability act of 1980, 42 u.s.c.a. §§ 9601-9675. 173. superfund enforcement, supra note 172. 174. id. 175. id. 2018] indiana’s public health is in jeopardy 131 protection from liability to state and local governments that “involuntarily” acquired a superfund site so long as no negligence or intentional misconduct is involved and the government did not cause or contribute to the contamination.176 thus, assuming the city of east chicago involuntarily acquired the former u.s.s. lead site and did not intentionally place public housing there, the echa, and idem likely will not be found financially liable for cleanup of the wchc. v. causes of action a. state statutory remedies the lack of environmental protection laws in the early twentieth century allowed heavily industrialized cities, like east chicago, to become contaminated quickly. indiana law now provides for several ways for the state to recover177 from toxic chemical contamination. one avenue for recovery is an environmental remediation loan program to assist and encourage the remediation, rehabilitation, and reuse of contaminated land (commonly called “brownfields”), created with the intent that cities and local government entities will actively engage in brownfield remediation and development. contaminated lands located in areas178 of poverty or socioeconomic distress, such as east chicago, are supposed to have a priority ranking in receiving financial assistance. perhaps if these laws were179 in place in the 1970s when the wchc was built, east chicago would have acted to rehabilitate and revitalize the contaminated land instead of building lowincome housing on top of it. indiana law also provides for enforcement and legal actions on behalf of the state for the unchecked environmental pollution by companies. under this law,180 it is illegal to “[d]ischarge, emit, cause, allow, or threaten to discharge, emit, cause, or allow any contaminant or waste . . . either alone or in combination with contaminants from other sources, into the environment.” another indiana law181 mandates that a person who violates any provision of indiana’s environmental laws, permits, or orders is liable for a $25,000 civil penalty per day of violation, and may be enjoined by the idem from continuing the violation. the $25,000182 per day of violation civil penalty would have a significant deterrent impact on companies who polluted on the wchc site for decades. the statute’s penalty,183 176. id. 177. see eason, schneider, & groppe, supra note 82 (noting that the 1970s, when the wchc was built, was an era of lax environmental regulations). 178. environmental remediation revolving loan program, ind. code ann. § 13-19-5-1 (2007). see also cooper indus., llc v. city of south bend, 899 n.e.2d 1274, 1284 (ind. ct. app. 2010) (discussing the purpose of the environmental remediation revolving loan program). 179. ind. code ann. § 13-19-5-8 (2016). 180. ind. code ann. § 13-30 (2016). 181. ind. code ann. § 13-20-2-1(1) (2016). 182. ind. code ann. § 13-30-4-1 (2016). 183. see rutter, supra note 22. 132 indiana health law review [vol. 15:109 if applied to u.s.s. lead, atlantic richfield, and dupont also exceeds east chicago’s estimated cleanup cost of $56 million, which amounts to roughly six years of violations. 184 the indiana environmental legal action (ela) statute provides another cause of action for environmental disasters that allows individuals to bring suit against a person that caused or contributed to the release of a hazardous substance, and recover costs of a removal or remedial action. indiana law185 defines an environmental legal action as “any legal action brought to recover reasonable costs associated with removal or remedial action involving a hazardous substance . . . released into the surface or subsurface soil . . . that poses a risk to human health and the environment.” the indiana legislature enacted186 this statute “to shift the financial burden of environmental remediation to the parties responsible for creating contaminations” in the hopes to overcome barriers to redevelopment and economic renewal. ela claims have a ten-year statute187 of limitation. indiana courts have also ruled that a cause of action accrues and188 the statute of limitation period begins to run when a claimant knows, or should know, that the damage of a negligent act has occurred. because idem, the189 epa, and the state of indiana were parties to a consent decree with atlantic richfield and dupont in 2014, the parties had actual knowledge that190 environmental damage had occurred and have until the year 2024 to bring ela claims. another indiana environmental law allows a citizen to bring a suit against polluters or government officials in the name of the state. the statute provides:191 [a] citizen of indiana . . . may bring an action for declaratory and equitable relief in the name of the state of indiana against . . . a company, a corporation . . .a state agency or an officer of the state, a city, a town, a county, a local government unit, and agency, or an official of a city, a town, a county, a local government unit, or an agency, or another legal entity or their legal representative, agent, or assigns for the protection of the environment of indiana from significant pollution, impairment, or 184. janzen, supra note 94. 185. ind. code ann. § 13-30-9-2 (west 1997). see reed v. reid, 980 n.e.2d 277, 289 (ind. 2012) (interpreting the plain and ordinary meaning of “caused” or “contributed” to require some involvement by the actor which produces a result). see also jdn prop., llc v. vanmeter enter., inc., 17 n.e.3d 357, 363 (ind. ct. app. 2014) (finding that the ela does not require a plaintiff to sue the person who caused or contributed to pollution, just a person). 186. ind. code ann. § 13-11-2-70.3 (west 2016). 187. cooper indus., llc v. city of south bend, 899 n.e.2d 1274, 1284 (ind. 2009). 188. ind. code ann. § 13-30-9-2.5 (west 2011). see ind. code ann. § 34-11-2-11.5 (west 2011) (providing that a person may seek to recover costs incurred for a removal action, a remedial action, or a corrective action incurred not more than ten years before the date the action is brought). 189. wehling v. citizens nat’l bank, 586 n.e.2d 840, 842 (ind. 1992). 190. see consent decree, supra note 167. 191. ind. code ann. § 13-30-1-1 (west 2016). 2018] indiana’s public health is in jeopardy 133 destruction.192 this law gives courts discretion to grant temporary and permanent equitable relief for pollution. however, this chapter of the law is geared toward remediation193 and rehabilitation of the land, not to provide compensation for personal injury, and is intended to benefit the environment of the state, not an individual. 194 b. individual victims independent causes of action may be unsuccessful for individual residents of the wchc due to the high cost involved in hiring a lawyer and bringing an independent tort claim against a major chemical polluter that has considerable financial resources. constitutional due process does not require the provision of counsel in all civil cases, but only presumes a right to counsel in cases involving incarceration. thus, since the victims’ right to counsel is limited, the victims195 may have to rely on pro bono services to bring their claim or find a lawyer willing to work on a contingency-fee basis. if individual victims overcome the high cost associated with lawsuits, they may face additional barriers on the path to recover from the negative effects of living in the wchc, such as proving causation and overcoming a statute of limitations. causation can be difficult for an individual victim to prove because harm from toxic chemical exposure is often not noticed right away and may have come from multiple polluters. if a victim develops cancer from toxic chemical196 contamination, it is difficult to prove that the toxic chemical exposure was the proximate cause of the cancer. 197 by the time a victim learns of the toxic chemical exposure as the cause of the victim’s harm, the statute of limitations may have run out. for most civil198 claims, indiana residents only have a six-year statute of limitation.199 nevertheless, since illness stemming from toxic chemical contamination may go undiscovered for several years, indiana law provides some leeway on the statute of limitations for torts related to toxic chemical contamination in the environment. indiana has a longer statute of limitations for deficiency in200 192. ind. code ann. § 13-30-1-1 (west 2016). 193. ind. code ann. § 13-30-1-11 (west 2016). 194. walling v. appel serv. co., inc., 641 n.e.2d 647, 652 (ind. ct. app. 1994). 195. in re gault, 387 u.s. 1 (1967). 196. elizabeth b. forsyth, solving widespread toxic chemical exposure: a taxing job, 29 va. envtl. l. j. 115, 122 (2011). 197. id. at 123. 198. id. at 124. 199. ind. code ann. § 34-11-2-7 (2016). 200. see cooper indus., llc v. city of south bend, 899 n.e.2d 1274, 1284 (ind. 2009) (reasoning that a “statute of limitation does not begin to run against a cause of action before that cause of action exists, i.e. before a judicial remedy is available to the plaintiff.”). see also pflanz v. foster, 888 n.e.2d 756, 758-59 (ind. 2009) (determining that a cause accrues when all the elements of a cause of action can be shown and that it is not necessary for the full extent of damage 134 indiana health law review [vol. 15:109 improvements to real property, benefitting claimants by giving them more time to bring claims. the statute provides for recovery of damages, whether based201 on contract, tort, nuisance, or another legal remedy for: (1) a deficiency or an alleged deficiency in the design, planning, supervision, construction, or observation of construction of an improvement in real property; (2) an injury to real or personal property arising out of a deficiency; or (3) an injury or wrongful death of a person arising out of a deficiency; may not be brought against a designer or possessor unless the action is commenced within the earlier of ten (10) years after the date of substantial completion of the improvement or twelve (12) years after the completion and submission of plans and specifications to the owner if the action is for a deficiency in the design of the improvement.202 thus, the wchc residents have ten years to bring a claim against their landlords who had possession and supervision of the housing complex at the time any of the residents contracted lead poisoning. c. class action class action lawsuits require plaintiffs to meet certain criteria to bring a claim. in theory, a class action suit against polluting businesses may be a viable203 alternative for residents of the wchc because the criteria for class actions are met. joining over one thousand residents in a single suit is not practicable, the204 residents all lived in contaminated housing units, the claims of the representatives would be typical of the claims of the class, and the representative parties will surely fairly and adequately protect the interests of the class. while class205 actions can reduce costs to the individual in bringing the lawsuit, these types of cases are not received well in mass tort cases because the members of the class may be suffering from different afflictions from diverse sources, thus rendering all members of the class unable to be treated as a single plaintiff. on the other206 hand, a class action may not work for wchc residents because, in large-claim situations where individual harms may differ, courts find individual lawsuits to be superior because they allow each plaintiff their day in court. 207 be known or ascertainable). 201. ind. code ann. § 32-30-1-5(d) (2016). 202. id. 203. one or more members of an affected class sues on behalf of all members, the class is so numerous that joinder of all members is impracticable, questions of fact or law are common to the class, the claims or defenses of the representatives are common to those of the class, and the representatives will fairly and adequately protect the claims of the class. fed. r. civ. p. 23. 204. id. 205. id. 206. forsyth, supra note 196, at 123. 207. william b. rubenstein, newberg on class actions § 4:88. comparing class 2018] indiana’s public health is in jeopardy 135 d. mass tort mass torts are another way for common claims to be heard at once, preserving fairness and efficiency. mass tort cases often treat each plaintiff208 individually, and may be an alternative to a class action suit if the claimants do not meet the requirements of a class action, such as having common claims or defenses among the entire class. in a case of mass exposure to a toxic chemical, “individual issues of causation and injury are likely to vary among potential class members” which may prohibit the filing of a class action. the outcome of a209 mass tort action may differ from the outcome of a class action due to how plaintiffs are treated procedurally. e. risk tax some scholars suggest a risk tax should be levied on the production of certain chemicals. revenue generated by that tax would then go into a fund to210 compensate victims for harms resulting from toxic chemical exposure. a211 benefit of this tax would be that it helps a wider group of people affected by toxic chemical exposure rather than providing a remedy for a few individuals who brought a tort claim.212 a portion of the fund could be used for medicaid, which provides healthcare to poor populations who are often disproportionally exposed to environmental health hazards and have little resources to combat the problem. another portion213 of the fund could also be used for monitoring and treatment of health problems that result from environmental health hazards and toxic chemical exposure. the214 fund could also be used to finance programs that “decrease exposure pathways [including cleanup of contaminated sites], educate the public, and better treat chemically-related diseases.”215 vi. conclusion since news of the lead contamination beneath the wchc broke in 2017, the epa has been faced with legal action, cleanup orders, and settlements. these216 actions to alternate forms of litigation – large claims cases (5th ed. west 2016). 208. id. 209. forsyth, supra note 196, at 124. 210. id. at 132. 211. id. 212. id. 213. id. 214. id. 215. id. 216. see generally technical and legal documents: uss lead, u.s. epa https://www.epa.gov/uss-lead-superfund-site/technical-and-legal-documents-uss-lead [https://perma.cc/h67p-bqd4] (last updated jan. 17, 2018). 136 indiana health law review [vol. 15:109 remedial actions are certainly warranted and long overdue. perhaps what we know now will lessen the likelihood of another lead-induced public health crisis occurring in the future. a. what have we learned? based on this recent public health disaster and the government’s poor track record of timely responses to environmental health crises, it is likely that public perception regards government agencies and actors as unhelpful and untrustworthy. indiana residents may not have confidence in the government after seeing what happened in flint and east chicago. as a solution, some scholars call for a replacement of “the current system which trades human health for profit, that places the burden of proof on the ‘victims’ as opposed to the polluting industries, legitimatize human exposure to harmful chemicals . . . exploits economically and politically vulnerable populations, [and] delays cleanup activities based on race, class, and geographic location.” however, a complete217 overhaul of an unjust system is not something that is likely to happen. encouraging government transparency, communication, and cohesive action would be more effective in combating public health crises stemming from environmental contamination. from an interdisciplinary perspective, the epa should not be the only government agency involved in the west calumet housing complex cleanup process. “as the recent situation in flint, mi has shown us, health emergencies can be unexpected and require a public health approach to address the needs of the community.”218 b. preventative action must be taken it is the responsibility of humanity to look after the health and wellbeing of future generations, especially once we become aware of problems to be treated. because past environmental wrongs and health problems cannot be solved, preventative action must be taken to preserve the health of the environment and communities in the state of indiana. the government must take actions to ensure the most vulnerable populations are protected and made aware when they are subject to serious health hazards like lead poisoning. indiana should be responsive and proactive in remedying the ill health effects of the east chicago crisis; we do not want to be “another flint.” going forward, rules and regulations that aim to prevent the disparate health effects of environmental racism must be enforced. 1. comprehensive and concrete response strategy the city attorney for east chicago encountered inconsistencies in federal agencies’ regulation for lead levels, which was confusing in trying to find out whether those laws were violated and whether compensation to victims was necessary. a more comprehensive version of the already-existing laws is219 217. bullard, supra note 74, at 1041-42. 218. beltran, supra note 65. 219. zilenski, supra note 2. 2018] indiana’s public health is in jeopardy 137 needed to streamline and expedite the process of discovering contamination, notifying residents, and cleaning up the problem. the epa cannot be the only agency involved; state and local agencies are needed to reach a solution, too. would the creation of an emergency law for environmental chemical disasters such as this, in addition to cercla, help matters? in my opinion, an interdisciplinary emergency response law modeled after cercla but with an emphasis on public health and a plan to locate safe housing would have greatly assisted the victims of the wchc. legislative responses to environmental health crises have played an effective role in responding to the occurrence of environmental health hazards in other situations. h.r. 4479, also known as the “families of flint act,” was introduced in 2016 as a bill to provide emergency assistance related to the flint water crisis and amends the safe drinking water act. indiana should follow michigan’s lead and create similar legislation to220 help the affected families of east chicago. indiana recently introduced senate bill 322 to help identify lead poisoning in children. this bill would require the state department of health to develop221 and distribute to primary health care providers a series of questions about a child’s exposure to lead, and may trigger a recommendation for blood lead testing depending on the family’s responses. this bill, requires reporting of the blood222 lead test results to the state health commissioner, who must then conduct a public health investigation of the child’s home and school if the child has a blood lead level of at least ten micrograms per deciliter. this bill also gives the state health223 commissioner authority to order the property manager or owner to control existing lead hazards, and to issue noncompliance orders prohibiting the use of the property if the lead hazard is not controlled. if passed, this bill is a224 wonderful example of an interdisciplinary approach to help residents solve lead hazards existing in their homes or schools. 2. review of residential ordinances and permitting requirements residential communities, especially ones that are government-subsidized, should not be built on top of contaminated soil. the statutory creation of a multiagency task force combining officials with hud, the epa, and the department of health to review strategies to annually review federal programs to combat lead poisoning is another avenue where governmental agencies can do their due diligence to make sure public health of populations are protected. however,225 these programs must be enforced and the government must be held accountable for inter-governmental task forces to work. 3. educational outreach the health of entire generations of children growing up on contaminated soil 220. h.r. 4479, 114th cong. 2nd session (2016). as of january 2018, the families of flint act has not yet been passed. 221. s.b. 233, 112th gen. assemb., reg. sess. (ind. 2018). 222. id. 223. id. 224. id. 225. 42 u.s.c.a. § 247b-3 (1992) (west 2016). 138 indiana health law review [vol. 15:109 should no longer be sacrificed. the epa acknowledged that when it comes to lead poisoning at superfund sites, “education is the key.” statutes that provide226 for expansion of community education programs about lead poisoning may be a step in the right direction. if people in the community are taught about lead227 poisoning, they may recognize its indicators and be more empowered to take the appropriate steps to seek medical or legal assistance. grants for lead poisoning related activities, which include community outreach and education targeted at people with lead contamination with the goal of reducing ongoing exposure may also help affected communities heal, as well as providing an outlet to have their issues redressed. 228 in some instances, results of environmental investigations of toxic chemicals are only communicated to government officials and not the public, as evinced229 by east chicago in regards to the wchc situation. a solution to toxic chemical contamination that involves the community and focuses on “[i]mplementing community-based programs . . . allow citizens to be informed of the findings and learn the skills to combat lead actively in their communities” and would likely achieve great results. lower levels of government and the people affected need230 to be notified of what is happening in their community. if someone in power, like the mayor of east chicago, is notified, they must be compelled to take action. if everyone is involved and participating to find a solution, environmental health disasters will be solved faster and more efficiently. it is “the adoption of a new paradigm of decision making altogether that is more democratic and participatory, that empowers communities to more effectively engage, and that incorporates changes to the very social structure of american society.” only with a new231 point of view and an interdisciplinary approach to toxic chemical contamination crises can communities like the wchc be safe from crises related to public health and environmental contamination in the future. 226. lead at superfund sites, supra note 41. 227. 42 u.s.c.a. § 247b-1 (2016). see also 42 u.s.c.a. § 247b-3 (2016). 228. 42 u.s.c.a. § 247b-16 (2016). 229. waterhouse & smith, supra note 13, at 113. 230. id. 231. konisky, supra note 78, at 13. nonmedical exemptions to public school vaccination mandates in the post-pandemic world: solutions within existing state frameworks lucien j. dhooge* “if an individual deeply and sincerely holds beliefs that are purely ethical or moral in source and content . . . those beliefs certainly occupy in the life of that individual a place parallel to that filled by god in traditionally religious persons.”1 “liberty of conscience is one thing. license to endanger the lives of others by practices contrary to statutes passed for the public safety and in reliance upon modern medical knowledge is another.”2 abstract: the article examines issues relating to nonmedical exemptions to vaccination as a condition of public-school attendance. the article contends that the public health impacts of exemptions may be mitigated through the application of existing state frameworks relating to procedural tightening, counseling and persuasion, assessments of sincerity and good faith, the application of public emergency laws, and transparency. the article identifies best practices in each of these frameworks. the article concludes that nonmedical exemptions are unlikely to be eliminated. as such, public health and educational authorities must act to prevent further erosion of the benefits associated with vaccination. introduction on october 1, 2021, california governor gavin newsom announced plans to add covid-19 (“covid”) vaccines to the list of vaccinations required to attend school in-person, contingent upon completion of the biologics license application approval process by the u.s. food and drug administration (“fda”).3 governor newsom directed the california department of public health (“dph”) to initiate the administrative process to add covid vaccines to the existing list of ten required vaccinations and to be phased in by grade span.4 however, on april 14, 2022, the california health and human services agency (“hhsa”) announced a postponement of the implementation of governor newsom’s order until july 2023 due to the fda’s slow pace in approving * sue and john staton professor of law, scheller college of business, georgia institute of technology. 1. welsh v. united states, 398 u.s. 333, 340 (1970). 2. anderson v. state, 65 s.e.2d 848, 852 (ga. ct. app. 1951). 3. see press release, off. of the governor, california becomes first state in nation to announce covid-19 vaccine requirements for schools (oct. 1, 2021) (on file with author). 4. id. see also cal. health & safety code §§ 120335(b) (1-10) (2022) (listing vaccinations against diphtheria, haemophiles influenzae type b, measles, mumps, pertussis, polio, rubella, tetanus, hepatitis b, and varicella as conditions for in-person school attendance). 24 indiana health law review [vol. 20:23 covid vaccines for children and the lack of time to implement the mandate before the start of the 2022-23 academic year.5 the california dph is authorized to require vaccination for “[a]ny other disease deemed appropriate by the department, taking into consideration the recommendations of the advisory committee on immunization practices of the united states department of health and human services, the american academy of pediatrics, and the american academy of family physicians.”6 california’s requirement of covid vaccines was followed by louisiana’s. in december 2021, governor john bel edwards allowed an administrative rule proposed by the louisiana department of health to take effect, which added covid vaccines to the list of required vaccinations for school attendance and child day care.7 in so doing, governor edwards overruled the louisiana house committee on health and welfare, which rejected the proposed rule earlier in the month.8 as a result, vaccination for covid was added to the list of eleven existing vaccinations required for in-person school attendance.9 as in california, the rule was to become effective upon completion of the biologics license application approval process by the fda, which, at the time, was only applicable to the vaccine produced by pfizer-biontech to those sixteen years of age and older.10 california and louisiana’s vaccination mandates are subject to statutory provisions, allowing for students (or parents acting on their behalf) to opt out by objecting to the vaccination. louisiana’s exemption permits students eighteen years of age and younger to opt out of vaccination through a “written dissent from [the pupil’s] parents.”11 the california exemption is limited to pupils who submitted a letter or affidavit stating beliefs opposed to vaccination prior to january 1, 2016.12 the exemption is applicable to private and public elementary 5. see soumya karlamangla, california delays k-12 vaccine mandate, n.y. times (apr. 18, 2022), https://www.nytimes.com/2022/04/18/us/california-covid-vaccine.html [https://perma. cc/n3y9-x4ce]. 6. cal. health & safety code §§ 120335(b) (1-10) (2022). 7. see letter from john bel edwards, governor, state of louisiana, to lawrence a. bagley, chairman, house comm. on health and welfare, state of louisiana (dec. 14, 2021) (on file with author). 8. id. at 1. 9. see la. admin. code tit. 51, §§ 701(a)(1)-(7), (e) (2022) (listing vaccinations against diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis a and b, varicella, and meningococcal infection as conditions for in-person school attendance). 10. see letter from denise m. hinton, chief scientist, u.s. food & drug admin., to elisa harkins, global senior dir., pfizer, inc. 2 (may 10, 2021) (reconfirming authorization of the pfizerbiontech vaccine for emergency use in individuals sixteen years of age or older on december 11, 2020, and authorizing use in individuals twelve to fifteen years of age). 11. la. admin. code tit. 51, §§ 701(c), (e) (2022) (recognizing an exemption to covid vaccination for any individual attending any school or day care center based upon a “written dissent” submitted by the individual or his or her parent or guardian). 12. see cal. health & safety code § 120335(g)(1) (2022). 2023] nonmedical exemptions to public school vaccination mandates 25 and secondary schools, child day care centers, day nurseries, nursery schools, family day care homes, and development centers located within the state.13 individual exemptions are to remain in effect until a pupil enrolled in the next grade span as defined by statute, at which time the exemption was to expire and vaccination becomes a prerequisite to school attendance.14 exemptions from vaccination requirements such as those provided in louisiana and attempted by california are widespread throughout the united states. forty-four states and the district of columbia permit exemptions based upon religious objections to vaccination.15 sixteen states also recognize philosophical or conscience-based objections to vaccination.16 legislation adding conscience-based objections has been introduced in several statehouses since the beginning of the covid pandemic.17 ii. vaccines and vaccination vaccination is the “medical process by which an agent similar to the disease or virus being prevented is deliberately introduced into a non-exposed individual, thereby causing the body to produce antibodies against the underlying illness.”18 the term “vaccination” was coined by edward jenner as a result of his work with cowpox.19 michael mcdonnell and fredrick askari describe vaccination as an example of active immunization in which the recipient’s immune system is induced to produce antibodies against a pathogen as a result of administering an immunobiological agent in the form of a vaccine.20 the development of vaccines 13. id. 14. id. grade spans are defined as birth to preschool, kindergarten to grade six, and grades seven through twelve inclusive. see cal. health & safety code §§ 120335(g)(2)(a)-(c), (g)(3) (2022). 15. see infra notes 31-39 and accompanying text. 16. see infra notes 40-51 and accompanying text. 17. see, e.g., h.b. 30, 2022 reg. sess. (ala. 2022) (“sincerely held personal beliefs”); h.b. 238, 32nd leg., 1st reg. sess. (alaska 2022) (“philosophical grounds”); s.b. 398, 89th leg., 2022 reg. sess. (kan. 2022) (“theistic and non-theistic moral and ethical beliefs as to what is right and wrong that are sincerely-held with the strength of traditional religious views”); h.b. 1453, 137th leg., reg. sess. (miss. 2022) (“philosophical belief” and “conscientious belief”); h.b. 1665, 101st leg., 2d reg. sess. (mo. 2022) (“conscientious belief”); h.b. 1035, 167th leg., 2d sess. (n.h. 2022) (creating “conscientious objector” status); h.b. 4620, 85th leg., reg. sess. (w. va. 2022) (providing parents are “free to choose . . . as it relates to immunizations). 18. steve p. calandrillo, vanishing vaccinations: why are so many americans opting out of vaccinating their children?, 37 u. mich. j. l. reform 353, 362 (2004) (citing james g. hodge, jr. & lawrence o. gostin, school vaccination requirements: historical, social, and legal perspectives, 90 ky. l. j. 831, 837 n.19 (2002)). 19. stefan riedel, edward jenner and the history of smallpox and vaccination, 18 proc. baylor u. med. ctr. 21, 24 (2005). 20. w. michael mcdonnell & frederick k. askari, immunization, 278 jama 2000, 2000 26 indiana health law review [vol. 20:23 and their widespread distribution are one of the most important medical achievements in the twentieth century.21 vaccination has eradicated, prevented, or controlled numerous life-threatening and debilitating diseases, such as diphtheria, measles, meningitis, polio, rubella, and tuberculosis, and resulted in “a dramatic reduction in morbidity and mortality due to vaccine preventable illnesses.”22 prior to the development of vaccines, there were 200,000 cases and 4,000 deaths attributable to pertussis and 20,000 cases and 1,800 deaths attributable to polio occurring in the united states on an annual basis.23 on a global scale, the world health organization (“who”) has estimated that vaccination and resultant immunization prevent two to three million deaths annually.24 undoubtedly, vaccines are “literally lifesavers.”25 the importance of vaccination extends beyond individual well-being and has a significant impact on social well-being. vaccination protects the individual recipient and those with whom the recipient comes into contact, including persons medically unable to receive vaccinations or for whom vaccination is only partially effective.26 vaccination, and the failure to vaccinate also have enormous economic consequences. vaccines save billions of dollars every year which (1997). 21. see mark navin, values and vaccine refusal: hard questions in ethics, epistemology, and health care 6 (routledge, 2016) (describing vaccines as “a huge success”); alexandra minna stern & howard markel, the history of vaccines and immunization: familiar patterns, new challenges, 24 health affs. 611, 611 (2005) (describing vaccination as represent[ing] the single greatest promise of biomedicine: disease prevention”). 22. alicia novak, comment, the religious and philosophical exemptions to statecompelled vaccination: constitutional and other challenges, 71 u. pa. j. const. l. 1101, 1105 (2005) (citing ross d. silverman, no more kidding around: restructuring non-medical childhood immunization exemptions to ensure public health protection, 12 annals health l. 277, 281-82 (2003)). 23. sandra w. roush & trudy v. murphy, historical comparisons of morbidity and mortality for vaccine-preventable diseases in the united states, 298 jama 2155, 2156 tbl.1 (2007). see also hillel y. levin, why some religious accommodations for mandatory vaccinations violate the establishment clause, 68 hastings l. j. 1193, 1198 (2017) (discussing disease eradication and control as a result of vaccination). 24. see 10 facts on immunization, world health org., https://www.who.int/mongolia/ health-topics/vaccines/10-facts-on-immunization [https://perma.cc/w5xt-lch2] (last updated mar. 2018). see also megan gibson, note, competing concerns: can religious exemptions to mandatory childhood vaccinations and public health successfully coexist?, 54 u. louisville l. rev. 527, 528 (2016) (describing the success of the who’s smallpox eradication program and the global polio eradication initiative). 25. dorit rubinstein reiss & lois a. weithorn, responding to the childhood vaccination crisis: legal frameworks and tools in the context of parental vaccine refusal, 63 buff. l. rev. 881, 883 (2015). see also robert i. field, vaccine declinations present new challenges for public health, 33 pharmacy & therapeutics 542, 542 (2008) (concluding that “it would be safe to say that vaccines have saved more lives than other medical technology”). 26. see gibson, supra note 24, at 541-42. 2023] nonmedical exemptions to public school vaccination mandates 27 would otherwise be spent treating vaccine preventable diseases.27 the failure to vaccinate also bears a multi-billion price tag for the u.s. healthcare system.28 these costs are in addition to the impacts upon the labor force and productivity as a result of the continuing prevalence of vaccine preventable diseases.29 for example, more than thirty-thousand, otherwise avoidable deaths, occur in the united states annually as a result vaccine preventable diseases.30 for all of its health and economic benefits, vaccination is not without controversy. the society of anti-vaccination was founded contemporaneously with edward jenner’s development of the smallpox vaccine in 1796, based upon the belief that vaccination was “an inappropriate meddling in the work of god.”31 more recent opposition to vaccination has asserted a wide variety of reasons including “objections based on effectiveness, transmission of other diseases, fear of harmful effects . . . religious or philosophical beliefs . . . [and] governmental interference with personal autonomy.”32 this controversy has only intensified as a result of the development of covid vaccines with proand anti-vaccination supporters engaging in increasingly confrontational rhetoric and tactics.33 novak discusses concerns regarding the introduction of foreign substances into the 27. see martha mccarthy, student vaccination requirements: can nonmedical exemptions be justified?, 320 educ. l. rep. 591, 607 (2015). 28. u.s. healthcare costs attributable to vaccine preventable diseases are estimated at ten dollars billion annually. see calandrillo, supra note 18, at 427. see also anthony ciolli, religious and philosophical exemptions to mandatory school vaccinations: who should bear the costs to society?, 74 mo. l. rev. 287, 290 (2009). 29. see james lobo, note, vindicating the vaccine: injecting strength into mandatory school vaccination requirements to safeguard the public health, 57 b.c. l. rev. 261, 271 (2016). 30. ciolli, supra note 28, at 290; see roush & murphy, supra note 23, at 2155 (identifying societal costs associated with vaccine preventable diseases as including missed time from school and work, doctor’s visits, and hospitalizations). 31. calandrillo, supra note 18, at 388. 32. gibson, supra note 24, at 535. see also calandrillo, supra note 18, at 390-93 (discussing medical risks associated with vaccination); hodge & gostin, supra note 18, at 844-49 (discussing anti-vaccination sentiment in general). 33. see, e.g., bridges v. houston methodist hosp., no. h-21-1774, 2021 wl 2399994, at *1-2 (s.d. tex. june 12, 2021) (dismissing claims challenging houston methodist hospital’s covid vaccine mandate and describing as “reprehensible” the claim that the policy constitutes medical experimentation in violation of the nuremberg code); complaint, cal. educators for med. freedom v. l.a. unified sch. dist., no. 21-cv-2388 (c.d. cal. mar. 17, 2021) (claiming that policies requiring vaccination constitute nonconsensual medical experimentation and clinical research); richard pan, anti-vaccine extremism is akin to domestic terrorism, wash. post (feb. 28, 2021), https://www.washingtonpost.com/opinions/anti-vaccine-extremism-is-akin-to-domestict e r ro r ism /2 0 2 1 /0 2 /2 6 /7 3 6 aee2 2 -7 8 7 e-1 1 eb-8 1 1 5 -9 ad 5 e9 c0 2 1 1 7 _ s tory.h tml [https://perma.cc/8uxv-7d4n] (contending that anti-covid vaccination campaigns are propaganda in an effort to market “alternative remedies and magical supplements” which could result in unnecessary deaths and are thus akin to domestic terrorism). 28 indiana health law review [vol. 20:23 human body, the absence of vaccine preventable disease in the community, distrust of public health officials, personal autonomy, and religious objections.34 reiss discusses safety concerns such as vaccine toxicity and damage to the immune system and belief in the superiority of “natural immunity.”35 tomsick attributes anti-vaccination sentiment to beliefs that the government and regulatory agencies have concealed information regarding medical risk and that pharmaceutical companies are motivated by profit rather than safety.36 iii. vaccination, religion, conscience, and state law a. vaccination and state law every state requires vaccination against certain communicable diseases as a condition for school attendance.37 the vast majority of school vaccination laws apply to both public and private schools.38 these policies are not entirely uniform but nevertheless nearly unanimous with respect to several diseases.39 for 34. novak, supra note 22, at 1106-07. 35. dorit rubinstein reiss, thou shalt not take the name of the lord thy god in vain: use and abuse of religious exemptions from school immunization requirements, 65 hastings l.j. 1551, 1553 (2014). 36. emma tomsick, note, the public health exemptions demand for revoking non-medical to compulsory vaccination statutes, 34 j. l. & health 130, 153 (2020) (citing anna kata, a postmodern pandora’s box: anti-vaccination misinformation on the internet, 28 vaccine 1709, 1713 (2010)). 37. see state school immunization requirements and vaccine exemption laws, u.s. dep’t of health & human servs. ctrs. for disease control & prevention 7-9, app. a (2017), https://www.cdc.gov/phlp/docs/school-vaccinations.pdf [https://perma.cc/zk4b-sg3c]. for a comprehensive overview of state vaccination requirements as a condition for attendance at public and private educational institutions, see generally hodge & gostin, supra note 18. 38. see id. (noting that forty-six state school vaccination laws are applicable to public and private educational institutions). all fifty state school vaccination laws are applicable to day care facilities. id. 39. see hepatitis b vaccine mandates for child care and k-12, immunization action coal. 1-2 (2019), https://www.cdc.gov/hepatitis/hbv/vaccchildren.htm [https://perma.cc/cms94k3n]. every state requires the polio vaccine for those students attending childcare centers and elementary schools and the dtap vaccine for diphtheria, tetanus, and pertussis for those students attending childcare centers and elementary and secondary schools. see polio vaccine mandates for child care and elementary schools, immunization action coal. 1-2 (2020), https://www.cdc. gov/vaccines/parents/diseases/polio.html [https://perma.cc/4cgx-q7lk]; dtap vaccine mandates for elementary and secondary schools, immunization action coal. 1-2 (2020), https://www. cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html [https://perma.cc/ffe6-nhx5]. vaccination for haemophiles influenza is required in every state for children attending daycare centers. see hib vaccine mandates for childcare, immunization action coal. 1-2 (2019), https://www.cdc.gov/ vaccines/parents/diseases/hib.html [https://perma.cc/fe3x-q87w]. other vaccines are subject to fewer requirements. 2023] nonmedical exemptions to public school vaccination mandates 29 example, forty-eight states require vaccination for hepatitis b for child care centers, elementary, and secondary schools.40 the mmr vaccine for measles, mumps, and rubella is required in every state for attendance at elementary and secondary schools and child care centers.41 elementary and secondary schools and child-care centers are subject to mandatory varicella vaccination in all states with the exception of south dakota.42 these requirements are paramount due to the absence of federal vaccination requirements as a condition of admission to public schools. b. religious exemptions to vaccination forty-four states and the district of columbia grant exemptions to students based upon religious objections to vaccination.43 the language creating these exemptions varies by state ranging from belief to active practice of religious principles to membership in a recognized congregation. the significance of these differences is uncertain given the sparsity of interpretive case law. specifically, in workman v. mingo city board of education, the court of appeals for the fourth circuit concluded that the termination of religious exemptions in west virginia did not impermissibly interfere with the free exercise of religion.44 in whitlow v. california, the u.s. district court for the southern district of california concluded that the u.s. constitution does not require religious exemptions, and that the right to practice religion freely does not give individuals the liberty to expose the community to communicable disease or children to the risk of ill health and death.45 in love v. state department of education, the california court of appeals held that repeal of the state’s religious 40. dtap vaccine mandates for child care and elementary schools, immunization action coal. 1-2 (2019), https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html [https:// perma.cc/6kzf-hl8e]. 41. mmr vaccine mandates for child care and k-12, immunization action coal. 1-2 (2019), https://www.cdc.gov/vaccines/vpd/mmr/public/index.html [https://perma.cc/p5yg-3gk7]. 42. varicella vaccine mandates for child care and k-12, immunization action coal. 1-2 (2020), https://www.cdc.gov/vaccines/vpd/varicella/hcp/recommendations.html [https://perma. cc/2sdy-6g5l]. 43. religious exemptions are not recognized or are chronologically limited in california, connecticut, maine, mississippi, new york, and west virginia. see cal. health & safety code § 120335(g)(1) (2022) (eliminating exemptions unless filed before january 1, 2016, and subject to termination upon enrollment in an advanced grade span); conn. gen. stat. §§ 10-204a(b)(1)-(7) (2022) (eliminating exemptions unless filed before april 28, 2021); 2019 me. leg. serv., ch. 154 (h.p. 586) (l.d. 798 (2019)) (eliminating exemptions effective september 1, 2021); miss. code ann. § 41-23-47 (2022); 2019 n.y. sess. laws, ch. 35 (a2371-a) (2022) (eliminating exemptions effective immediately); w. va. code § 16-3-4(h) (2022) (limiting exemptions to medical reasons). 44. workman v. mingo cty. bd. of educ., 419 f.app’x 348, 353-54 (4th cir. 2011). 45. whitlow v. california, 203 f. supp. 3d 1079, 1084, 1086 (s.d. cal. 2016). 30 indiana health law review [vol. 20:23 exemption did not transgress the free exercise of religion.46 in brown v. smith, the california court of appeals upheld the elimination of religious exemptions on the grounds of the state’s interest in public health and safety, and the potential for significant social burdens associated with the absence of widespread vaccination.47 the largest number of exemptions are based upon religious beliefs or convictions. twenty-three states and the district of columbia exempt public school students from vaccination on these grounds.48 these exemptions are broader than those requiring active practice of religious principles and membership in a religious congregation in at least four states arkansas, maryland, massachusetts, and ohio. in arkansas, the court found that religious exemption limited to members of a “recognized church or religious denomination” was too narrow and required school administrators and courts to make impermissible distinctions between sincere religious beliefs.49 in maryland, the supreme court struck down an exemption limited to “adherents of a recognized church or religious denomination” as a violation of the establishment clause of the u.s. constitution.50 in massachusetts, the supreme court struck down an exemption limited to objectors who subscribe to “tenets and practice of a recognized church or religious denomination” as a violation of the establishment clause of the u.s. constitution.51 the ohio court of appeals denied custody to a mother due to failure to immunize her child based upon her inability to identify a religious denomination to which she belonged or teachings that dictated her refusal to vaccinate.52 closely related to belief and convictions are exemptions based upon 46. love v. state dep’t of educ., 240 cal. rptr. 3d 861, 873 (cal. ct. app. 2018). 47. brown v. smith, 235 cal. rptr. 3d 218, 225 (cal. ct. app. 2018). 48. for states granting exemptions on the basis of religious beliefs, see ark. code ann. § 6-18-702(d)(4)(a) (2022); del. code ann. § 131(6) (2022); d.c. code § 38-506(1) (2022); ga code ann. § 20-2-771(c) (2022); ind. code §§ 20-34-3-2(a)(1)-(3) (2022); md. code educ. § 7-403(b)(1) (2022); mass. gen. laws ch.76 § 15 (2022); minn. stat. § 121a-15(3)(d) (2022); mo. rev. stat. § 167.181(3) (2022); mont. code ann. §§ 20-5-403(1)(d), (2)(a)(ii), 20-5405(1)(a)-(d) (2022); nev. rev. stat. § 392.437 (2022); n.h. rev. stat. ann. § 141-c.20-c(ii) (2022); n.m. stat. ann. § 24-5-3(a)(3) (2022); n.c. gen. stat. § 130a-157 (2022); n.d. cent. code § 23-07-17.1(3) (2022); or. rev. stat. § 433.267(1)(c)(a) (2022); r.i. gen. laws § 16-382(a) (2022); tex. educ. code ann. § 38.001(c)(1)(b) (2022); utah code ann. § 53g-9-303(3) (2022); vt. stat. ann. tit.18, § 1122(a)(3)(a) (2022); wash. rev. code § 28a.210.090(1)(b) (2022); s.c. code ann. regs. § 61-8(ii)(a)(2) (2022). for states granting exemptions on the basis of religious convictions, see mich. comp. laws § 333.9215(2) (2022); ohio rev. code ann. § 3313.671(b)(4) (2022). 49. boone v. bozeman, 217 f. supp. 2d 938, 947 (e.d. ark. 2002). 50. davis v. state, 451 a.2d 107, 113-14 (md. 1982). 51. dalli v. bd. of educ., 267 n.e.2d 219, 223 (mass. 1971). 52. in re i.w., no. c-180095, 2019 wl 1781486, at *2 (ohio ct. app. apr. 24, 2019). 2023] nonmedical exemptions to public school vaccination mandates 31 “religious grounds” and “personal beliefs.”53 these exemptions are undefined by statute or case law but may be broader given the absence of reference to an underlying religious belief or conviction. new jersey’s exemption may also be broad given its focus on free exercise rights of objectors.54 exemptions granted by three states based upon dissent and objections are broader.55 three categories of exemptions require active engagement by religious objectors. three states require objectors to demonstrate that they are adherents to a religious belief.56 this category seems to imply that objectors follow specific religious teachings in their daily lives. similarly, five states require objectors to adhere to religious practices, once again implying active participation rather than mere belief.57 this conclusion may be drawn with greater certainty in the three states which require active membership in a religious congregation in order to qualify for an exemption.58 c. conscience-based exemptions to vaccination conscience-based objections may be divided into two categories. the first, and most common, exemption requires some kind of belief. twelve states require belief, although they differ in their descriptions. three states grant exemptions based upon philosophical beliefs.59 washington’s statute is broader as it also 53. see ariz. rev. stat. ann. § 15-873(a)(1) (2022) (personal belief); idaho code § 394802(2) (2022) (religious grounds); ill. comp. stat. § 5/27-8.1(8) (2022) (religious grounds); ky. rev. stat. ann. § 214.036 (2022) (religious grounds); 24 pa. cons. stat. § 13-1303a(d) (2022) (religious grounds); wis. stat. § 252.04(3) (2022) (religion). 54. see n.j. stat. ann. § 26:1a-9.1 (2022) (“free exercise of the pupil’s religious rights”). 55. see la. stat. ann. § 17:170(e) (2022) (dissent); okla. stat. tit. 70, § 1210.192(2) (2022) (objection); wyo. stat. ann. § 21-4-309(a) (2022) (religious objection). 56. see colo. rev. stat. § 25-4-903(2)(b)(i) (2022) (“adherent to a religious belief whose teachings are opposed to immunizations”); kan. stat. ann. § 72-6262(b)(2) (2022) (“adherent of a religious denomination whose religious teachings are opposed to . . . inoculations”); s.d. codified laws § 13-28-7.1(2) (2022) (“adherent to a religious doctrine whose teachings are opposed to such immunization”). 57. see ala. code § 16-30-3(1) (2022); fla. stat. § 1003.22(5)(a) (2022); haw. rev. stat. § 302a-1156(2) (2022); tenn. code ann. § 49-6-5001(b)(2) (2022); va. code ann. §§ 22.1-271.2(c)(i), 2(e), 32.1(d)(1) (2022). 58. see iowa code § 139a.8(4)(a) (2) (2022) (“tenets and practices of a recognized religious denomination of which the applicant is an adherent or member”); neb. rev. stat. § 79-221(2) (2022) (“tenets and practices of a recognized religious denomination of which the student is an adherent or member”); alaska admin. code tit. 4, § 06.055(b)(3) (2022) (“tenets and practices of the church or religious denomination of which the applicant is a member”). the exemption in nebraska is broader than those in alaska and iowa as the statute also grants exemptions to students based upon their “personal and sincerely followed religious beliefs.” neb. rev. stat. § 79-221(2) (2022). 59. see ark. code ann. § 6-18-702(d)(4)(a) (2022); or. rev. stat. § 433.267(1)(c)(a) 32 indiana health law review [vol. 20:23 permits exemptions based upon personal objections but is narrower to the extent that exemptions regardless of their basis are inapplicable to vaccination for measles, mumps, and rubella.60 north dakota’s statute similarly mentions philosophical beliefs but, unlike arkansas, oregon, and washington, expressly requires such beliefs be “sincerely held” and not a “pretense for avoiding legal requirements.”61 pennsylvania describes belief as “a strong moral or ethical conviction similar to a religious belief” thereby injecting an undefined degree of sincerity and fervor into the exemption determination.62 an additional four states delink belief from philosophy by simply granting exemptions based upon personal belief.63 however, arizona requires an explicit statement of the personal belief underlying the exemption request.64 the statutes in three other states similarly delink belief from philosophy but require that beliefs be “conscientiously held.”65 applicable case law in minnesota declares that personal convictions should be treated equally with similarly situated religious beliefs.66 the second type of exemption requires no particular belief objecting to vaccination. statutes in oklahoma and michigan require only objection to vaccination.67 however, a 2007 opinion by the michigan attorney general’s office provides objections must be “actual,” and local health departments are empowered to require explanations and determine if an exemption has been properly claimed.68 idaho’s statute grants exemptions based upon “religious or other grounds.”69 louisiana’s exemption is arguably the most liberal of all by merely requiring a “written dissent” to vaccination.70 whether these distinctions represent true differences in the nature of the protected beliefs and exemptions is (2022); wash. rev. code § 28a.210.090(1)(c) (2022). 60. see wash. rev. code § 28a.210.090(1)(c) (2022). 61. n.d. admin. code § 33-06-05-01(c) (2022). see also n.d. cent. code § 23-07-17.1(3) (2022). 62. 28 pa. code § 23.84(b) (2022). see also 24 pa. cons. stat. § 13-1303a(d) (2022). 63. see ariz. rev. stat. ann. § 15-873(a)(1) (2022); colo. rev. stat. § 25-4-903(2)(b)(i) (2022); utah code ann. § 53g-9-303(3) (2022); wis. stat. § 252.04(3) (2022). 64. see ariz. admin. code § r9-6-706(a)(5) (2022). but see colo. rev. stat. § 25-4903(2.3)(b)(v) (2022) (prohibiting the state from requiring explanation of the religious or personal beliefs serving as the basis for an exemption request). 65. minn. stat. § 121a-15(3)(d) (2022); ohio rev. code ann. § 3313.671(b)(4) (2022); tex. educ. code ann. § 38.001(c)(1)(b) (2022). see minn. stat. § 121a.15(3)(d) (2022) (exemption limited to diphtheria, hepatitis b, pertussis, polio, and tetanus); tex. educ. code ann. § 38.001(a) (2022) (exemption limited to diphtheria, mumps, polio, rubeola, rubella, and tetanus). 66. see in the matter of the welfare of x (sibley cty. ct., family div. dec. 29, 1977), cited in off. of the att’y gen., 1980 wl 119579, at *4 (minn. july 23, 1980). 67. see mich. comp. laws § 333.9215(2) (2022); okla. stat. tit. 70, § 1210.192(2) (2022). 68. off. of the mich. att’y gen., 2007 wl 2734012, at *5 (sept. 14, 2007). 69. idaho code § 39-4802(2) (2022). 70. la. stat. ann. § 17:170(e) (2022). see also la. admin. code tit. 28, §§ 303(e), 1101(e) (2022). 2023] nonmedical exemptions to public school vaccination mandates 33 uncertain as there is an absence of interpretive case law.71 iv. nonmedical exemptions to vaccination and public health nonmedical exemptions to vaccination may have significant impacts on public health. widespread and broadly drawn exemptions may damage the success of vaccination programs.72 supporters of exemptions are not necessarily unconcerned about public health and the common well-being.73 instead, exemption supporters and public health advocates reach different conclusions about how to achieve these goals due to competing and often conflicting assumptions. on one side of the conflict are religious teachings about right and wrong and strongly held moral and ethical considerations regarding individual autonomy.74 these beliefs are confronted by social concerns and epidemiological data on the other side of the issue.75 conscience-based objections to vaccination are more susceptible to criticism due to their perceived lack of connection to widely accepted religious doctrines and teachings. this lack of connection and the vagueness of such exemptions in state statutes may lead to more conscience claims as compared to religious claims 71. the language utilized in the recognized bases for exemption from school vaccination requirements closely tracks language in recent state legislation prohibiting covid vaccination mandates in the employment, education, and public accommodations contexts. see, e.g., h.b. 2001, § 1(d)(8), 2021 spec. sess. (kan. 2021) (“theistic and non-theistic moral and ethical beliefs as to what is right and wrong that are sincerely-held with the strength of traditional religious views”); n.d. cent. code § 34-03-10(2)(c)(2) (2022) (“philosophical or moral beliefs opposed to . . . immunization”); tenn. code ann. § 14-2-102(a) (2022) (prohibiting private businesses, governmental entities, schools or local educational agencies from compelling or taking “an adverse action against a person to compel the person to provide proof of vaccination if the person objects to receiving a covid-19 vaccine for any reason”); utah code ann. § 26-68-201(2)(c) (2022) (prohibiting public and private employers from requiring vaccination for covid if receiving such a vaccination conflicts with an employee or prospective employee’s “sincerely held personal belief”); exec. order ga. 40 § 1 (tex. 2021) (prohibiting public and private employers and public accommodations from requiring vaccination or proof thereof based upon “personal conscience”). 72. see, e.g., timothy j. aspinwall, religious exemptions to childhood immunization statutes: reaching for a more optimal balance between religious freedom and public health, 29 loy. u. chi. l. j. 109, 114 (1997) (concluding that broad religious exemptions are inconsistent with public health objectives); allan jacobs, do belief exemptions to compulsory vaccination programs violate the fourteenth amendment?, 42 u. mem. l. rev. 73, 76 (2011) (contending that widespread religious and philosophical exemptions endanger existing vaccination programs and public health as a result of their “expanding and unlimited scope”). 73. see aspinwall, supra note 72, at 111 (arguing that religious teachings often share concerns about public health and the common well-being with public health advocates). 74. id. 75. id. 34 indiana health law review [vol. 20:23 and the consequent spread of disease and harm to non-claimants.76 the result may be a proliferation of “exemptions of convenience” given the absence of required documentation of sincere beliefs opposed to vaccination.77 proliferation may pose a risk to public health and safety especially during an epidemic of vaccine preventable disease.78 these risks include decreases in vaccination rates necessary to establish and maintain so-called herd immunity and overtaxing of resources to process exemption requests at the expense of vaccine distribution.79 “herd immunity” and the “herd effect” occur when a critical mass of vaccination rates within a population is reached, thereby conferring protection upon, and reducing the risk of infection to, persons who remain unvaccinated by reason of choice or medical necessity.80 according to gonzalez, states offering conscience-based and religious exemptions have higher overall exemption rates which poses a threat to herd immunity for vaccine preventable diseases.81 increases in the number of conscience-based exemptions nationwide and linking such increases with the ease of obtaining exemptions and resultant enhanced risk of the spread of vaccine preventable diseases.82 moreover, horowitz argues that conscience-based exemptions “could lead to wholesale ineffectiveness of the vaccination program [in times of a health emergency] and create under-inclusiveness issues”.83 thompson concluded that nonmedical exemptions threaten herd immunity for 76. see sara mahmoud-davis, balancing public health and individual choice: a proposal for a federal emergency vaccination law, 20 health matrix 219, 245 (2020). 77. see calandrillo, supra note 18, at 432 (contending that conscience-based exemptions “pose a risk to societal welfare because they allow parents to decline to vaccinate their children even where there is no documentation of a sincere belief opposed to immunization”). however, the same criticism is equally applicable to religious objectors. see lobo, supra note 29, at 273-74 (concluding that the absence of prohibitions upon vaccination in the most widely practiced religions in the united states indicates that most religious objectors “are actually using religion as a proxy for a non-religious motive”). 78. see, e.g., mahmoud-davis, supra note 76, at 244 (contending that “[t]he number of individuals who might claim vaccination exemptions on philosophical grounds could pose significant risks to the public health and safety” in a multi-state emergency). 79. id. at 244. saad b. omer et al., nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence, 296 j. am. med. ass’n 1757, 1761 (2006) (contending that states offering conscience-based and religious exemptions have higher overall exemption rates). 80. see gibson, supra note 24, at 528-29. 81. victor diego gonzalez, religion in the time of measles: prescriptions for minimizing the public health threats associated with religious exemptions from mandatory vaccinations, 15 cardozo pub. l. pol’y & ethics j. 413, 434 (2017). 82. mccarthy, supra note 27, at 608. 83. ben horowitz, a shot in the arm: what a modern approach to jacobson v. massachusetts means to mandatory vaccination during a public health emergency, 60 am. u. l. rev. 1715, 1743 (2011). 2023] nonmedical exemptions to public school vaccination mandates 35 vaccine preventable diseases.84 v. should conscience-based exemptions be eliminated? critics of conscience-based exemptions have raised several grounds in support of their elimination. most of these grounds relate to individual and collective concerns. unlike other types of medical decision-making, vaccinations, and their absence, are unique in their ability to impact individual and collective health and well-being.85 individual well-being is not limited to objectors but also includes those whom they may infect and, in particular, society’s most vulnerable members children, the immunocompromised, and those medically unable to be vaccinated.86 collective interests most commonly cited by critics include public health, achievement and preservation of herd immunity, and overall well-being associated with control of the spread of communicable diseases.87 these collective interests are subject to protection through invocation of the communal self-defense principle.88 the supreme court stated that the communal selfdefense principle in the context of vaccination provides that “a community has the right to protect itself against an epidemic of disease which threatens the safety of its members” which epidemic is considered to be an event of “paramount necessity.”89 the court concluded that creation of a minority privilege to defy mandatory vaccination for smallpox presents “the spectacle . . . of the welfare and safety of an entire population being subordinated to the notions of a single individual who chooses to remain a part of that population” and refusing to “hold it to be an element in the liberty secured by the constitution of the united states that . . . a minority of persons . . . should have the power thus to dominate the 84. joseph w. thompson et al., impact of addition of philosophical exemptions on childhood immunization rates, 32 am. j. preventative med. 194, 199 (2007). 85. see gibson, supra note 24, at 541-42. 86. id. see also jacobs, supra note 72, at 101 (criticizing belief exemptions as creating “an unnecessary risk of children acquiring communicable diseases in a school environment . . . [and violating] the right of children to enjoy the safest possible school environment”). 87. see, e.g., gibson, supra note 24, at 544 (concluding that the balance between individual liberty and collective welfare must weigh in favor of public health thereby requiring the elimination of nonmedical exemptions); novak, supra note 22, at 1125 (arguing for the abolition of nonmedical exemptions on public health grounds); tomsick, supra note 36, at 142 (arguing for the abolition of nonmedical exemptions in order to achieve and maintain herd immunity); michael lederman et al., defeat covid-19 by requiring vaccination for all. it’s not un-american. it’s patriotic, usa today (aug. 6, 2020), https://www.usatoday.com/story/opinion/2020/08/06/stop-coronaviruscompulsory-universal-vaccination-column/3289948001/ [https://perma.cc/6skp-dgds] (contending nonmedical exemptions violate the social contract). see also supra notes 59-60 and accompanying text. 88. see novak, supra note 22, at 1123. 89. jacobson v. massachusetts, 197 u.s. 11, 27 (1905). https://www.usatoday.com/story/opinion/2020/08/06/stop-coronavirus-compulsory-uni https://www.usatoday.com/story/opinion/2020/08/06/stop-coronavirus-compulsory-uni 36 indiana health law review [vol. 20:23 majority when supported in their action by the authority of the state”.90 these interests may be further described as compelling thereby permitting states to eliminate all nonmedical exemptions, religious or otherwise, without impermissibly intruding upon the rights of objectors.91 these concerns, while undoubtedly significant, must be balanced against individual interests such as voluntariness, consent, and the primary right and responsibility of parents, to make determinations regarding the perceived wellbeing of their children.92 these rights and responsibilities include the authorization of medical treatment for their minor children.93 this authorization requires consent beyond “cursory agreement to vaccinations based on provider recommendations and legal mandates.”94 rather, consent requires “disclosure, comprehension [and] voluntariness” on behalf of the party charged with decisionmaking.95 this is not to argue that parental interests are sufficient in and of themselves to overturn vaccination mandates for children. rather, it is to argue that elimination of nonmedical exemptions, including those based upon conscience, negates voluntariness and consent and treats recipients as a collective manner rather than individuals worthy of particularized assessment.96 it is also important to not overestimate the effect of nonmedical exemptions on disease control. the elimination of nonmedical exemptions will not prevent all future outbreaks of vaccine preventable disease.97 instead, future outbreaks will result from a combination of failure or inability to vaccinate and vaccine 90. id. at 37-38. 91. see, e.g., sherr v. northport-e. northport union free sch. dist., 672 f. supp. 81, 88 (e.d.n.y. 1987) (holding that “[i]t has been settled law for many years that claims of religious freedom must give way [to] the competing interest of society in fighting . . . contagious diseases through mandatory inoculation programs”). see also gibson, supra note 24, at 543-44 (concluding that the elimination of nonmedical exemptions would be sustained through application of the compelling interest test). 92. see katherine drabiak, disentangling dicta: prince v. massachusetts, police powers, and childhood vaccine policy, 29 annals of health l. & life sci. 173, 184-85 (2020). 93. see, e.g., macklin v. ark. dep’t of human servs., 624 s.w.3d 869, 874 (ark. 2021) (holding the state’s interest in promoting the health and safety of its children must yield to the rights of parents to make fundamental decisions regarding the lives of their children and the balancing of these interests was a matter of legislatively-determined public policy in which the court could not interfere); in re lepage, 18 p.3d 1177, 1181 (wyo. 2001) (holding that the state department of health had no statutory authority to inquire into the sincerity of parents’ religious beliefs regarding the vaccination of their children); off. of the att’y gen., 1991 wl 634929, at *1 (mont. feb. 27, 1991) (instructing school districts to refrain from challenging affidavits stating parents’ religious beliefs regarding vaccination of their children). 94. drabiak, supra note 92, at 185 (citing kristine severyn, jacobson v. massachusetts: impact on informed consent and vaccine policy, 5 j. pharmacy & l. 249, 252-53 (1995)). 95. drabiak, supra note 92, at 185. 96. id. 97. id. at 204 (contending that “[p]resenting the removal of [nonmedical exemptions] as a sufficient solution misleadingly simplifies vital facts behind why outbreaks occur”). 2023] nonmedical exemptions to public school vaccination mandates 37 failure.98 some vaccine recipients will fail to develop antibodies that confer immunity, some recipients may develop disease despite vaccination, and immunity will inevitably wane over time.99 the existence of nonmedical exemptions has little, if any involvement, with these issues. enforcement difficulties have also been cited as an argument for elimination of nonmedical exemptions.100 these difficulties arise primarily from the creation and application of appropriate tests for determining who may qualify for an exemption.101 leaving aside the argument that difficulty in applying vague language in statutes should not serve as an excuse for the wholesale gutting of legislatively created rights, it is without dispute that abuses of exemptions may occur. abuses are much more likely to occur in states where there is minimal oversight of exemption processes.102 this lack of oversight and accompanying deference to claims may result in “exemptions of convenience” in certain circumstances.103 some critics have concluded that anyone who wants an exemption will receive it.104 there are few legal obstacles to elimination of conscience-based exemptions. the united states supreme court has not directly ruled on whether an individual has a right to object to vaccination of his or her children on the basis of conscience.105 in dicta, the court has stated that parents “cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds.”106 according to the court, the free exercise of religion “does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.”107 giving these statements greater weight than they are due as dicta and recognizing that they address religious issues relating to vaccination, it is fair to conclude conscience-based exemptions would equally fail. 98. see gregory a. poland & robert m. jacobson, the re-emergence of measles in developed countries: time to develop the next-generation measles vaccination?, 30 vaccine 103, 103 (2012). “vaccine failure” is defined as either primary wherein a percentage of recipients fail to develop antibodies resulting in immunization or waning in which effectiveness of the vaccine decreases over time. 99. see drabiak, supra note 92, at 204-05. 100. see novak, supra note 22, at 1124. 101. id. 102. id. 103. see § 39-4802(2), supra note 58. 104. see novak, supra note 22, at 1124. 105. see zucht v. king, 260 u.s. 174, 176 (1922) (holding that school admission may be conditioned upon vaccination but did not address a conscience-based objection to such requirement). for a detailed discussion of u.s. supreme court jurisprudence regarding vaccination, see mccarthy, supra note 27, at 599-600. 106. prince v. massachusetts, 321 u.s. 158, 166 (1944) (relating to the application of labor laws to the distribution of jehovah’s witness’ pamphlets by a minor). 107. id. at 166-67. 38 indiana health law review [vol. 20:23 this conclusion is consistent with holdings in federal and state courts determining that the recognition of conscience-based objections is not constitutionally required.108 this conclusion is also consistent with administrative rules and regulations, judicial opinions, and opinions of attorneys general in states with otherwise robust protection of religious objections to vaccination. specifically, in kleid v. board of education, the court concluded that the failure to include conscience-based objections in kentucky’s religious exemption statute is not a violation of the establishment clause.109 in syska v. montgomery city board of education, the court held that the failure to include conscience-based objections in maryland’s religious exemption statute was constitutional.110 the office of attorney general in iowa concluded that iowa’s religious exemption was inapplicable to “ethical or moral beliefs outside of a recognized religion.”111 the office of attorney general in kansas concluded that the failure to include conscience-based objections in kansas’ religious exemption statute was not a violation of the establishment clause.112 the law is clear, states need not grant exemptions other than those deemed medically necessary.113 all of the above objections duly noted, the elimination of nonmedical exemptions, including those that are conscience-based, is unrealistic.114 conscience-based exemptions are too well-established under existing state law to be easily uprooted.115 furthermore, many states have not back-tracked despite the covid pandemic, but instead have sought to expand existing statutory exemptions with at least one state going as far as to determine that covid is not a public health emergency negating the application of nonmedical objections.116 an added obstacle is the understandable reluctance of courts to delve into religious and personal beliefs in a quest to separate sincere beliefs from claims 108. see, e.g., phillips v. city of new york, 27 f. supp. 3d 310, 313 (e.d.n.y. 2014), aff’d, 775 f.3d 538 (2d cir. 2015) (holding that religious exemptions to vaccination are not constitutionally required). 109. see kleid v. bd. of educ., 406 f. supp. 902, 907 (w.d. ky. 1976); 10a n.c. admin. code § 41a.0403 (2022) (providing that north carolina’s religious exemption is inapplicable to personal belief or philosophy not founded upon a religious belief). 110. syska v. montgomery cty. bd. of educ., 415 a.2d 301, 304 (md. ct. spec. app. 1980). 111. off. of the att’y gen., 1977 wl 18943, at *2-3 (iowa july 14, 1977). 112. off. of the att’y gen., 2012 wl 3782384, at *3-4 (kan. aug. 28, 2012). 113. see, e.g., calandrillo, supra note 18, at 429-30 (concluding that religious exemptions are “probably not required” and conscience-based exemptions are “certainly not required”); lobo, supra note 29, at 279 (stating that “no court has ever required a state to include anything other than a medical exemption to compulsory vaccination laws, despite the fact that most states have religious exemptions”); reiss, supra note 35, at 1563 (describing the judicial history of exemptions as “enabling, not mandating” nonmedical exemptions). 114. see, e.g., ciolli, supra note 28, at 290-93 (contending that the elimination of nonmedical exemptions is unrealistic given the current state of statutory and case law). 115. see supra notes 32-52 and accompanying text. 116. see off. of the att’y gen., 2021 wl 6275030, at * 1 (va. dec. 30, 2021). see also supra note 15 and accompanying text. 2023] nonmedical exemptions to public school vaccination mandates 39 asserted in bad faith or without adequate justification, however those terms may be defined.117 such quests require “high levels of entanglement” with individual beliefs, inquiries about which local school administrators, health department officials, and federal and state judges may be ill-equipped.118 authority to make these determinations may be misused and abused “especially if the decisionmaker does not share the values of the exemption-seeking parent, which is almost always the case.”119 the delegation of such authority also assumes a degree of sophistication about issues of religion and conscience which may be lacking or absent, especially if claimed exemptions are based upon beliefs and practices unfamiliar to decisionmakers. in this regard, compliance with legal standards is only part of the equation. empathy with individual claimants, open-mindedness regarding their beliefs, and even-handedness in the application of standards are also required. these traits are unlikely to be present in all cases. critics of nonmedical exemptions have alternatively argued in favor of retaining religious objections and abolishing conscience-based objections.120 leaving the unrealistic nature of such proposals aside for the reasons previously discussed, these arguments also fail to recognize the fine and often indistinguishable line between religion and conscience.121 the hallmarks of religion are threefold.122 the first component is belief, which consists of faith in “the mission of a certain individual or group prophet, incarnate god or church or assent to a particular interpretation of existence,” the desire to belong to a spiritual society which shares the same world-view, and release from daily life.123 117. see, e.g., reiss, supra note 35, at 1569 (stating that “[f]reedom of conscience and religion means that the state may not tell me if my beliefs are legitimate . . . [and] it is none of the state’s business what i believe, and it does not get to tell me that my beliefs are not worthy”). 118. id. at 1589. 119. id. at 1590. 120. see, e.g., gonzalez, supra note 68, at 418 (advocating the tightening of requirements for religious objections and the abolition of conscience-based objections); lobo, supra note 29, at 26364 (arguing for the creation of a uniform vaccination mandate to be adopted by the states in which religious objections are limited and conscience-based objections are eliminated); rials, supra note 68, at 238 (contending that conscience-based exemptions should be eliminated as they encourage “illegitimate objections” having no basis in science and interfere with the creation and maintenance of herd immunity). 121. see united states v. seeger, 380 u.s. 163, 174 (1965) (clark, j., concurring) (describing the distinction between conscience and religious belief as difficult due to the fact that “in no field of human endeavor has the tool of language proved so inadequate”). see also reiss & weithorn, supra note 25, at 918 (noting that distinguishing between religious and conscience-based objections can be “quite challenging and can lead to substantial debate”). 122. see lucien j. dhooge, the equivalence of religion and conscience, 31 notre dame j. l., ethics & pub. pol’y 253, 255-56 (2017) (defining religion as consisting of belief, action, and purpose). 123. john o. hayward, religious pretenders in the courts: unmasking the imposters, 20 trinity l. rev. 24, 28 (2014). 40 indiana health law review [vol. 20:23 belief is manifested through “categorical demands on action” that require satisfaction regardless of individual desire or societal incentives and disincentives.124 these actions are intended to serve a “higher good or ultimate end” beyond ordinary human existence.125 in a similar manner, conscience consists of belief and response.126 belief refers to identification of moral principles and assessment of context, which in turn, influence decision-making and judgments.127 decisions and judgments based upon such evaluations create a moral consciousness for each individual and provide him or her with a sense of self.128 response is a necessary element as a claim of conscience is “about what one must do, no matter what.”129 conscience often draws upon the same spiritual and transcendental beliefs that motivate religious actors.130 likewise, religious beliefs share characteristics with conscience-based thought.131 these belief systems do not operate independently 124. brian leiter, why tolerate religion?, 34 (princeton uni. press, 2013). 125. hayward, supra note 103, at 30. see also russell blackford, freedom of religion and the secular state 6 (2012). 126. see dhooge, supra note 95, at 266–67 (defining conscience as consisting of belief and response). see also steven d. smith, what does religion have to do with freedom of conscience?, 76 univ. colo. l. rev. 911, 923 (2005) (contending that conscience “involves more than mere belief: it entails acting living in accordance with central convictions”). 127. see darlene fozard weaver, conscience: rightly formed and otherwise, 132 commonwealth 10, 11 (sept. 18, 2005), https://www.commonwealmagazine.org/conscience [https://perma.cc/9j6s-6eum] (referring to conscience as “human knowledge of right and wrong . . . our moral consciousness, process of moral decision-making, and settled moral judgments or decisions”). see also elizabeth sepper, taking conscience seriously, 98 va. l. rev. 1501, 1526-27 (2012) (discussing the impact of perceptions of right and wrong upon moral decision-making). 128. see sepper, supra note 127, at 1526-27. see also martha c. nussbaum, liberty of conscience: in defense of america’s tradition of religious equality, 79 (2008) (describing conscience as the “core of [an individual’s] humanity”); dan w. brock, conscientious refusal by physicians and pharmacists: who is obligated to do what, and why?, 29 theoretical med. & bioethics 187, 189 (2008) (contending that conscience-based judgments “define who, at least morally speaking, the individual is, what she stands for, what is the central moral core of her character”). 129. leiter, supra note 124, at 95. leiter further describes conscience-based responses as “a kind of moral imperative central to one’s integrity as a person.” id. see also john rawls, a theory of justice, 207 (belknap press rev. ed., 1999) (1971) (describing claims of conscience as “binding absolutely” and non-negotiable). 130. see, e.g., welsh v. united states, 398 u.s. 333, 340, 343-44 (1970) (plurality opinion) (granting an exemption from compulsory military service on the basis of deeply and sincerely held beliefs deriving from purely moral and ethical sources); united states v. seeger, 380 u.s. 163, 16566 (1965) (holding that an agnostic belief system in which the existence of a supreme being remained an open question and the adherent’s words and deeds were motivated by a devotion to goodness and virtue for their own sake was sufficient to qualify for an exemption from military service as long as such belief system was sincere and meaningful). 131. see levin, supra note 23, at 1207. 2023] nonmedical exemptions to public school vaccination mandates 41 but parallel to one another with frequent overlaps.132 furthermore, conscience may occupy a place in the believer’s life, similar to those of religious adherents.133 conscience and religion share sufficient “critical core characteristics” as to be moral equivalents and, thus, subject to equivalent treatment under the law.134 courts and scholars have struggled with these issues in opinions dating back decades.135 local school boards and administrators, and health department officials are unlikely to possess any greater competence to resolve these issues, 132. id. 133. see, e.g., welsh, 398 u.s. at 340 (concluding that the beliefs at issue occupied “a place parallel to that filled by god” in religious persons); seeger, 380 u.s. at 166 (holding that the belief system at issue occupied a place in the life of the possessor parallel to that occupied by belief in god in the life of a religious adherent). 134. levin, supra note 23, at 1207. see also martha c. nussbaum, women and human development: the capabilities approach 208-09 (2000) (equating religious freedom and liberty of conscience and contending that fairness requires equal accommodation of both); michael j. sandel, democracy’s discontent: america in search of a public philosophy 65-71 (belknap press, 1998) (contending that conscience-based exemptions should be treated in a manner similar to those available for religious beliefs); dhooge, supra note 94, at 277-91 (arguing that religion and conscience are moral and legal equivalents); rodney k. smith, converting the religious equality amendment into a statute with a little “conscience,” 1996 byu. l. rev. 645, 662-74 (1996) (supporting the treatment of conscience-based exemptions in a manner similar to those available to religious beliefs). but see john garvey, what are freedoms for?, 54-55 (harv. univ. press, 2000) (supporting exemptions from civil obligations solely for religious beliefs and practices); andrew koppelman, conscience, volitional necessity, and religious exemptions, 15 legal theory 214, 234-36 (2009) (supporting a broad definition of religion and accompanying protection with weaker protections for claims of conscience); michael w. mcconnell, the origins and historical understanding of the free exercise of religion, 103 harv. l. rev. 1409, 14991500 (1990) (supporting exemptions from civil obligations solely for religious beliefs and practices); steven d. smith, the tenuous case for conscience, 10 roger williams u. l. rev. 325, 357 (2005) (supporting a broad definition of religion and accompanying protection with weaker protections for claims of conscience). 135. see, e.g., thomas v. rev. bd. of ind. emp’t sec. div., 450 u.s. 707, 714 (1981) (stating that defining religious belief and practice are “more often than not a difficult and delicate task”); see also sherr v. northport-east northport union free sch. dist., 672 f. supp. 81, 92 (e.d.n.y. 1987) (describing the determination of which denominations may qualify for an exemption as an “inherently tricky proposition”). compare davis v. beason, 133 u.s. 333, 342 (1890) (holding that religion “has reference to one’s views of his relations to his creator, and to the obligations they impose of reverence for his being and character, and of obedience to his will”), and united states v. macintosh, 283 u.s. 605, 633-34 (1931) (hughes, c.j., dissenting) (stating that “the essence of religion is belief in a relation to god involving duties superior to those arising from any human relation”), with torcaso v. watkins, 367 u.s. 488, 495 n.11 (1961) (finding buddhism, taoism, ethical culture and secular humanism to qualify as religions despite the absence of a belief in god). 42 indiana health law review [vol. 20:23 especially on behalf of multiple students in any given academic year. there are risks associated with fluid definitions and blurred boundaries. fluidity and blurring may lead to the creation of exemptions from otherwise binding legal obligations, which are especially acute when they impose costs and burdens upon others such as in the area of public health.136 misuse of exemptions by undeserving claimants is a further risk exacerbated by judicial limitations upon consideration of the truth or falsity of the contested beliefs.137 risks aside, however, fluidity is necessary in order to account for “the diversity of human experience with what people take to be the divine, transcendence, or mystery.”138 new and different viewpoints regarding imponderable questions should generally be welcomed rather than cast aside out of fear of misuse and concerns relating to potential overbreadth. vi. mitigating the impact of nonmedical exemptions on public health: solutions within existing state frameworks given the likelihood that nonmedical exemptions, including those that are conscience-based, will remain part of the legal landscape and may in fact increase in number, it is important to strike a balance between exemptions and public health. the underlying fundamental principle in achieving balance is recognition that neither interest has absolute priority.139 in practice, this means there will be occasions when the beliefs of objectors and the exemptions they seek must yield to the greater good in maintaining public health.140 it also means that objectors and their interests must be accommodated to the extent they do not cause significant harm to societal interests in disease control.141 136. see, e.g., lucien j. dhooge, public accommodation statutes and sexual orientation: should there be a religious exemption for secular businesses?, 21 wm. & mary j. women & l. 319, 356-58 (2015) (discussing the unworkability of religiously based exemptions for vital services). 137. see united states v. ballard, 322 u.s. 78, 85-86 (1944) (requiring that sincerity of religious beliefs be determined “without a view as to [their] truth or falsity”). see also winnifred fallers sullivan, the impossibility of religious freedom 3 (2005) (questioning the competence and ability of courts to define religion without establishing “a legal hierarchy of religious orthodoxy”). 138. nathan s. chapman, disentangling conscience and religion, 2013 u. ill. l. rev. 1457, 1477 (2013). 139. see aspinwall, supra note 72, at 134. 140. id. 141. id. see also drabiak, supra note 92, at 207 (contending that “[p]ublic health ethics requires maximizing noncompulsory strategies and permitting conscientious objections, which do not necessarily impede health officials’ desired outcomes”); douglas diekema, personal belief exemptions from school vaccination requirements, 35 ann. rev. public health 275, 275-92 (2014); alvin nelson el amin et al., ethical issues concerning vaccination requirements, 34 pub. health rev. 1, 5-6 (2012); douglas opel & douglas diekema, finding the proper balance between freedom and justice: why we should not eliminate personal belief exemptions to 2023] nonmedical exemptions to public school vaccination mandates 43 states may achieve balance through reexamination of the administrative processes by which nonmedical exemptions in general, and conscience-based exemptions in particular, are granted. optimal processes “encourage deliberative thought and [verification] of sincerity of beliefs.”142 fortunately, many states already have elements of such processes in their existing vaccination laws. what is missing is uniformity and consistency across state laws. this section of the article examines elements within existing state laws and identifies best practices with respect to the granting and maintenance of nonmedical exemptions. these proposals are described under the headings of procedural tightening, counseling and persuasion, sincerity and good faith, the continuation of exemptions in times of medical emergencies such as epidemics and outbreaks, and transparency. a. procedural tightening procedural tightening strategies focus on enhancing rigor with respect to processes by which individuals seek exemptions from vaccination.143 the goal of these strategies is to increase vaccination rates by creating more complex and rigorous processes which in turn deter objectors from seeking exemptions.144 some objectors may simply choose to accept vaccination rather than undertake a rigorous administrative process.145 there is a direct correlation between procedural complexity and the number of exemptions sought and ultimately granted.146 there is considerable support for such a correlation in research relating to religious exemptions to school vaccination requirements.147 this correlation is also supported in administrative law literature examining “the role of procedural mechanisms and institutional design in controlling and managing behavior.”148 vaccine mandates, 37 j. health pol., pol’y & l. 141, 141-57 (2012). 142. calandrillo, supra note 18, at 434. 143. see reiss & weithorn, supra note 25, at 974-79. 144. see ciolli, supra note 28, at 295-96. see also gonzalez, supra note 81, at 437. 145. see levin, supra note 23, at 1240. 146. see rials, supra note 60, at 218 (concluding that “the higher the rate of complexity in the process of applying for exemptions, the lower the rate of actual exemptions, and the lower the rate of complexity, the higher the rate of exemptions”). 147. for summaries of research correlating procedural complexity with lower numbers of exemptions in the context of school vaccination requirements, see, e.g., calandrillo, supra note 18, at 434-35; nili karako-eyal, beyond the ethical boundaries of solidarity: increasing vaccination rates through mandatory education to solidarity, 6 tex. a&m l. rev. 345, 362-63 (2019); reiss & weithorn, supra note 25, at 964. 148. reiss & weithorn, supra note 25, at 961 n.307. see also mathew d. mccubbins et al., administrative procedures as instruments of political control, 3 j. l. econ. & org. 243, 243 (1987); william f. west, formal procedures, informal processes, accountability, and responsiveness in bureaucratic policy making: an institutional policy analysis, 64 pub. admin. rev. 66, 67-68 (2004). 44 indiana health law review [vol. 20:23 procedural tightening must begin with the documentation necessary to obtain a nonmedical exemption. every state recognizing nonmedical exemptions requires a written statement from a parent, guardian, or student if he or she is over the age of eighteen years. however, the required form of these statements varies with some state statutes lacking explicit reference to any document other a writing of some type.149 jurisdictions requiring nothing more than a writing have tipped the balance too far in favor of exemptions. these policies lack the sufficient degree of rigor necessary to establish a bona fide exception to important public health requirements. exemptions may flourish in such an environment. signed statements with some informational requirements is a step in the right direction but also does not rectify the imbalance between individual and collective interests.150 the requirement of a notarized affidavit affirming the applicant’s beliefs and identifying their conflict with vaccination is a sounder approach.151 tennessee’s statute explicitly provides that affidavits are submitted under penalty of perjury, which is unnecessary duplicative given the affiant’s oath, but may have some effect on bad faith applicants and discourage “exemptions of convenience.”152 the utilization of required state forms is a preferable approach given that they 149. see ala. code § 16-30-3(1) (2022) (writing); d.c. code § 38-506(1) (2022) (writing submitted in good faith); fla. stat. § 1003.22(5)(a) (2022) (writing); haw. rev. stat. § 302a1156(2) (2022) (writing); idaho code § 39-4802(2) (2022) (writing); ind. code § 20-34-3-2(a)(1) (2022) (signed writing delivered to teacher or official who may order vaccination); kan. stat. ann. § 72-6262(b)(2) (2022) (signed writing); la. stat. ann. § 17:170(e) (2022) (“written dissent”); mass. gen. laws ch. 76, § 15 (2022) (writing); n.j. stat. ann. § 26:1a-9.1 (2022) (written statement); n.c. gen. stat. § 130a-157 (2022) (written statement); 24 pa. cons. stat. § 13-1303a(d) (2022) (writing); vt. stat. ann. tit. 18, § 1122(a)(3) (2022) (signed written document); wis. stat. § 252.04(3) (2022) (written statement provided to school); wyo. stat. ann. § 21-4-309(a) (2022) (“written evidence”); la. admin. code tit. 28, §§ 303(e), 1101(e) (2022) (“written dissent”). 150. see n.m. stat. ann. § 24-5-3(a)(2) (2022) (affidavit or written affirmation that religious beliefs do not permit administration of a vaccine or other immunizing agent); wash. rev. code § 28a.210.090(1)(b) (2022) (signed written certification of beliefs); ariz. admin. code §§ r9-6-706(a)(1)-(6) (2022) (signed statement disclosing names of parents, names and dates of birth of children for whom an exemption is sought, disclosure of the vaccine that is the subject matter of the request, statement of personal belief opposed to vaccination, and parents’ dated signature). 151. see ark. code ann. § 6-18-702(d)(4)(b) (2022) (signed affidavit affirming beliefs); ga. code ann. § 20-2-771(e) (2022) (signed affidavit affirming conflict); iowa code § 139a.8(4)(a)(2) (2022) (signed affidavit affirming tenets and practices); ky. rev. stat. ann. § 214.036 (2022) (signed affidavit affirming beliefs); neb. rev. stat. § 79-221(2) (2022) (signed affidavit affirming tenets and practices); n.h. rev. stat. ann. § 141-c-:20-(c)(ii) (2022) (notarized form affirming beliefs); tenn. code ann. § 49-6-5001(b)(2) (2022) (signed written statement affirming tenets and practices); alaska admin. code tit. 4, § 06.055(b)(3) (2022) (signed affidavit affirming conflict); 14 del. admin. code § 804(7.1.2) (2022) (signed affidavit affirming beliefs). 152. see tenn. code ann. § 49-6-5001(b)(2) (2022). 2023] nonmedical exemptions to public school vaccination mandates 45 promote uniformity throughout the jurisdiction. courts have held that the required use of state-generated forms is not a violation of free exercise rights nor compels speech by potential objectors.153 however, the utility of such forms is dependent on the information which the objector is required to disclose and affirm.154 the most complete approaches utilizing a state forms approach may be found in existing statutes and administrative rules in illinois and texas, and the former approach in connecticut prior to its elimination of nonmedical exemptions in 2019. forms required by these states are note-worthy, as they impose burdens on objectors which are not undue but nevertheless cumbersome. for example, the required form in texas may only be obtained through a written request to the state, must be notarized, and must be submitted to the admitting official of a school within ninety days of notarization.155 the required form in illinois must contain a detailed description of the objection including identification of the belief that is in conflict with a specific vaccination requirement.156 the form must also be signed by a health care provider describing information provided to the objecting party.157 the previous exemption provided by connecticut law required a description of the conflict between the vaccination requirement and the objector’s religious beliefs.158 the connecticut statute also required an extensive acknowledgement process involving judges, notary publics, and members of the state bar.159 these forms strike an appropriate balance between the rigor to protect 153. see w.b. by and through baker v. crossroads academy-central street, 2019 wl 6257963 (w.d. mo., 2019) (upholding the rejection of a handwritten objection to vaccination). see also b.w.c. v. williams, 990 f.3d 614, 618-22 (8th cir. 2021) (concluding that the required use of a state-generated form in order to obtain an exemption is not compelled speech in violation of the u.s. constitution). 154. see colo. rev. stat. §§ 25-4-903(2)(b)(ii)(b), 25-4-903(2.3)(b)(ii)-(v) (2022); n.d. cent. code § 23-07-17.1(3) (2022); or. rev. stat. § 433.267(1)(c)(a) (2022); r.i. gen. laws § 16-38-2(a) (2022); md. code regs. § 10.06.04.05(a) (2022); minn. r. 4604.0400 (2022); mo. code regs. ann. 19 § 20-28.010(1)(c)(2) (2022); mont. admin. r. 37.114.716(1) (2022); nev. admin. code 46-20 § (2)(2) (2022); s.c. code ann. regs. § 61-8(ii)(a)(2) (2022); s.d. admin. r. 44:81:06:01 (2022); utah admin. code § 396-100-5(1) (2022); 12 va. admin. code § 5-11080(a)(1) (2022); off. of the att’y gen., 2021 wl 6275030, at *5 (mich. sept. 14, 2007) (providing that local health departments may require utilization of exemption forms and require explanation of “other objection to immunization”). 155. see tex. health & safety code ann. §§ 161.0041(a)-(c) (2022) (requiring utilization of a form provided by the state, notarization, and receipt of the form through written request to the state). see also tex. educ. code ann. § 38.001(c)(1) (2022) (requiring utilization of a stateprovided form submitted to an “admitting official” within ninety days of notarization). 156. see ill. comp. stat. § 5/27-8.1(8) (2022). 157. id. 158. see conn. gen. stat. §§ 10-204a(b)(1)-(7) (2022). 159. id. (requiring acknowledgement by a judge of a court of record, a family support magistrate, a clerk or a deputy clerk of a court having a seal, a town clerk, a notary public, a justice of the peace, an attorney admitted to the connecticut state bar, or a school nurse). 46 indiana health law review [vol. 20:23 public health and the accommodation of individual belief. additional procedural tightening occurs in the small number of states requiring parties to identify the specific vaccinations to which they object or requiring objections to all vaccinations as a condition for exemption.160 these approaches may reduce the number of applications especially given the accompanying requirement that individuals describe the specific nature of their objection to each and every vaccination for which an exemption is sought. hawaii’s absolute prohibition upon a la carte exemptions may be the most effective approach to reducing the number of applications.161 however, the impact of this prohibition may be reduced to the extent that hawaii’s statute does not expressly require a detailed explanation of the applicant’s reason for seeking an exemption from all required vaccinations.162 illinois’ required identification of vaccinations, when combined with its previously-discussed detailed state form, may prove to be more effective.163 administrative regulations implementing wisconsin’s statutory exemption for religious beliefs and personal convictions may provide an additional means by which to discourage exemption applications. the signed statement of “religious or personal conviction grounds” submitted to the wisconsin department of health requires written evidence of prior receipt of required vaccinations.164 although the regulation does not explicitly provide as such nor is there governing case law, it may be implied that past receipt of a vaccination which is the subject matter of a current request disqualifies the applicant from an exemption.165 at the very least, past receipt of a vaccination should require an explanation of the changed circumstances underlying the new-found objection. resolution of this issue also may be useful in the determination of the applicant’s sincerity and good faith in seeking the exemption.166 although outright disqualification may be too harsh of a penalty and may fail to take into account changes in the applicant’s personal beliefs, prior receipt of the vaccination which is the subject matter of a current exemption request should require a detailed 160. see colo. rev. stat. § 25-4-903(2.3)(b)(ii)(a) (2022) (requiring identification of the vaccination from which an exemption is sought). see also ariz. admin. code §§ r9-6-706(a)(4)(5) (2022) (requiring identification of the vaccination from which an exemption is sought and statement of personal belief with respect to such vaccination); n.d. admin. code § 33-06-05-04 (2022) (providing that, while exemptions are available for all required vaccinations, objectors must identify specific vaccinations in their applications). 161. see haw. code § 11-157-5(b) (2022). see also novak, supra note 22, at 1109 (contending that individuals must be required to object to all vaccines in order to receive a conscience-based exemption). 162. see supra note 121 and accompanying text. 163. see ill. comp. stat. § 5/27-8.1(8) (2022). 164. wis. admin. code, dep’t of health serv’s § 144.05 (2022). 165. but see grzyb v. grzyb, 2009 wl 7388854 (va. cir. ct. 2009) (concluding that a parent’s prior receipt of vaccines does not mean that the parent has no bona fide religious objection to the vaccination of his or her child). 166. see infra notes 161-93 and accompanying text. 2023] nonmedical exemptions to public school vaccination mandates 47 explanation of the circumstances, necessitating the change and a more probing inquiry into the applicant’s sincerity and good faith. a final example of procedural tightening may be found in the five exemption statutes, which require periodic renewal. these statutes recognize that objections and resultant exemptions are not static but may change over time. three states expressly require annual renewal of exemption requests.167 texas’ and utah’s statutes provide that exemptions are effective for two years which, while preferable to no chronological limitations whatsoever, provides convenience to parents at the expense of school administrators and public health authorities.168 new mexico’s statute requires renewal every nine months.169 this period of time, not only adheres to the traditional school year for elementary and secondary students, but also requires parents to apply in advance of each new academic year. however, annual renewals more accurately reflect modern school attendance patterns as some portion of student populations may be expected to attend school for at least part of the summer. in any event, regardless of the form it takes, the placement of another obstacle in the path of objectors may reduce exemption applications which is the objective of procedural tightening. b. counseling and persuasion the second element of a balanced approach to the granting of nonmedical exemptions is counseling and persuasion. counseling consists of a review of educational materials provided by the federal or state government, an acknowledgement that the failure to be vaccinated increases the risk of personal infection as well as infection of others including classmates and family members, and that such infections may prove to be life-altering or life-threatening.170 counseling could be informal through providing parents with information or more intensive including the requirement that it be provided by medical personnel.171 more stringent counseling requirements such as the use of quizzes to verify informed consent could also be utilized.172 regardless of form, 167. see ark. code ann. § 6-18-702(d)(4)(b) (2022) (requiring an annual application process); vt. stat. ann. tit. 18, § 1122(a)(3) (2022) (requirement of annual signed statement). see also nev. admin. code 46-20 § (2)(1) (2022) (requiring annual submission of exemption requests). 168. see 25 tex. admin. code ann. § 97.62(2) (2022) (providing that the signed exemption form is effective for two years from the date of notarization); utah code ann. § 53g-9-303(4)(e) (2022). 169. see n.m. stat. ann. § 24-5-3(b) (2022) (providing exemptions are for a period of nine months and must be renewed in order to remain effective). 170. see gonzalez, supra note 81, at 441. 171. see silverman, supra note 22, at 285 (advocating mandatory consultation with medical personnel as a condition of granting exemptions to school vaccination requirements). see also mccarthy, supra note 27, at 598. 172. see reiss, supra note 35, at 1596 (stating that “[a] somewhat rigorous educational requirement seems appropriate, potentially with a short quiz at the end” in order to obtain an 48 indiana health law review [vol. 20:23 compliance with counseling requirements should be memorialized in signed statements.173 counseling requirements are not excessive given the risks associated with unvaccinated status and do not impose “insurmountable barriers” for those seeking exemptions.174 most individuals seeking exemptions could overcome these obstacles. even if they fail as a deterrent, these obstacles enhance the accuracy of the exemption process by requiring documentation and bolstering informed decision-making.175 additionally, less committed parents may decide to have their children vaccinated in order to avoid the time and effort associated with undergoing counseling.176 a crucial element of counseling is persuasion through education. persuasion and educational efforts emphasize “interventions that strive to change attitudes and minds” through “information, logic, and reason to empower an individual to make his or her own wise choices.”177 persuasive efforts should focus on the benefits of vaccination, the remoteness of risks associated with vaccination, and the avoidable risks that unvaccinated persons impose on themselves and those with whom they interact.178 more intensive educational programs may include information regarding the approval process for vaccines and safety profiles for specific vaccines.179 however the program as structured, should focus on the personal consequences associated with non-vaccination and avoid giving additional publicity to vaccine misinformation.180 exemption). 173. see devin w. quackenbush, religion’s hepatitis b shot: the arkansas general assembly established an overly broad religious exemption to mandatory immunization after the district court invalidated the original religious exemption mccarthy v. ozark school district, 42 creighton l. rev. 777, 819 (2009) (arguing in favor of signed statements in the form of affidavits). 174. reiss & weithorn, supra note 25, at 975. 175. id. 176. id. counseling and persuasion may be useful in convincing “vaccine hesitant” parents who have general and unarticulated anxiety about vaccines to immunize their children. id. at 929. weithorn and reiss further contend that counseling and persuasion will have little or no impact on so-called “vaccine rejectors” and “vaccine resistant” parents. id. 177. id. at 965. 178. see gonzalez, supra note 81, at 438 (advocating educational content that “increase[s] public knowledge about the life-saving benefits of vaccinations, about the remote risks posed by [. . .] vaccinations, and about the avoidable risks that non-vaccinations impose”). see also silverman, supra note 22, at 293. 179. see priya shetty, experts concerned about vaccination backlash, 375 lancet 970, 971 (2010) (quoting dr. paul offit of the children’s hospital of philadelphia as advocating “educational classes that teach the public what the safety profiles of different vaccines are, before they are allowed to opt out of vaccination”). 180. see tomsick, supra note 36, at 154 (concluding that “educational efforts that are not focused on vaccine misinformation, but rather focus on the personal consequences of not 2023] nonmedical exemptions to public school vaccination mandates 49 counseling and persuasion are part of the requirements for nonmedical exemptions in several states. the majority of these states require the completion of an educational module regarding the benefits associated with vaccination and the risks of non-vaccination.181 the content of these modules is not specified by statute, although vermont lists the information that must be disclosed in its educational materials including the requirement that such information be “evidence-based.”182 one state specifically allows for completion of the required education module in an online format.183 required education modules and the provision of vaccine information have been held not to violate the free exercise rights of potential objectors.184 while these statutes are preferable to no educational requirements whatsoever, they do not go far enough in ensuring adequate understanding of the magnitude of the decision to avoid vaccination and imposing a more formidable obstacle in the path of potential objectors. the addition of two requirements present in a small number of existing state statutes would address these shortcomings. initially, state educational modules should include a required review and signature by an independent individual as is the case in florida, illinois, oregon, and washington. each of these states require exemption applications to be reviewed and signed by medical personnel.185 a second vaccinating [. . .] have been more successful”). 181. see, e.g., ariz. rev. stat. ann. § 15-873(a)(1) (2022); ark. code ann. §§ 6-18702(d)(4)(c)(ii)-(iii) (2022) (requiring completion of an educational component and signed informed consent form by parents seeking exemption for their children); colo. rev. stat. § 25-4903(2)(b)(1) (2022) (requiring completion of an educational module or certificate as a condition of receipt of a nonmedical exemption); tex. health & safety code ann. § 161.0041(d) (2022); 14 del. admin. code § 804(7.1.2) (2022); minn. r. 4604.0400 (2022) (providing that schools may send “other information . . . related to immunization” to parents in addition to that required by state law); mich. att’y gen. op. no., 7205 at 1,5 (sept. 14, 2007) (permitting local health departments to provide information regarding vaccination to parents). see also supra note 150 and accompanying text. 182. vt. stat. ann. tit. 18, §§ 1122(a)(3)(b)(i)-(iii) (2022) (requiring review of educational materials relating to the risks of adverse reactions to vaccination, the increased risk to the child and others of contracting or carrying vaccine preventable diseases, and the heightened risk to those who cannot be vaccinated or who have higher risk of contracting disease and for whom this risk could be life-threatening). 183. see utah code ann. §§ 53g-9-304(3)(a)(i)-(ii), (3)(b)(i) (2022) (permitting completion of an online educational module unless the parent has an in-person consultation with a health official at a local health department). 184. see, e.g., nikolao v. lyon, 875 f.3d 310, 316 (6th cir. 2017) (holding the provision of information regarding the benefits of vaccination and risks associated with non-vaccination by a local health department in michigan did not intrude upon the free exercise of religion). 185. see ill. comp. stat. § 5/27-8.1(8) (2022) (requiring certificate of religious exemption to be signed by a health care provider and describing the efforts to educate parents on the benefits of vaccination and risks of non-vaccination to the child and the community); or. rev. stat. § 50 indiana health law review [vol. 20:23 requirement is administrative review of compliance with exemption processes by school administrators and local health departments.186 these additional hurdles have the advantages of improving parental understanding, enhancing the accuracy of the exemption process, combatting vaccine misinformation, and transforming the educational requirement into something more than a check-the-box exercise.187 these hurdles may discourage less committed parents and persuade undecided parents to permit vaccination of their children.188 although such instances may be rare, every such occurrence is a victory for public health by eliminating a potential vector for disease in the community and securing individual well-being. the infrequency of such occurrences aside, each such victory is well worth a more rigorous educational requirement. c. sincerity and good faith nonmedical objections to vaccination should require sincerity of belief.189 state statutes provide a starting point for the assessment of sincerity. unfortunately, these statutes utilize different terms to describe their sincerity requirements. these differences make comparisons across states difficult. a small group of states granting either religious exemptions or religious and conscience-based exemptions utilize the term “sincerity of belief.”190 an equally small group require that the beliefs be “bona fide.”191 perhaps closely related are requirements that the beliefs be actual or held in good faith.192 the mere presence 433.267(1)(c)(b)(i) (2021) (requiring the certification to receive an exemption be signed by a health care practitioner and describing the efforts to educate parents on the benefits of vaccination and risks of non-vaccination); wash. rev. code § 28a.210.090(2)(a) (2022) (requiring the certification to receive an exemption be signed by a health care practitioner and describing the efforts to educate parents on the benefits of vaccination and risks of non-vaccination). 186. see or. rev. stat. §§ 433.267(4), (7) (2021) (requiring review of exemptions for compliance with state law by school administrators and local health departments); 2007 mich. op. att’y gen. no. 7205, 2007 wl 2734012, at *1, 5 (sept. 14, 2007) (authorizing local health departments to determine if an exemption has been properly claimed pursuant to state law). 187. see infra text accompanying notes 146-48. 188. id. 189. but see dep’t of health v. curry, 722 so.2d 874, 878 (fla. dist. ct. app. 1998) (prohibiting inquiry into the sincerity of a religious belief serving as grounds for an exemption from vaccination). see infra text accompanying note 64. 190. see, e.g., mass. gen. laws ch. 76, § 15 (2022); n.d. admin. code § 33-06-05-01(1)(c) (2022). 191. see, e.g., haw. rev. stat. § 302a-1156(2) (2022) (bona fide religious tenets and practices); md. code ann. educ. § 7-403(b)(1) (2022) (bona religious beliefs and practices); n.c. gen. stat. § 130a-157 (2022) (bona fide religious beliefs). 192. see, e.g., d.c. code § 38-506(1) (2022) (objections filed in good faith); 2007 mich. op. att’y gen. no. 7205, 2007 wl 2734012, at *1, 5 (sept. 14, 2007) (requiring objection to be “actual”). 2023] nonmedical exemptions to public school vaccination mandates 51 of such beliefs is inadequate in pennsylvania, which requires that they be strongly held.193 other states assume the presence of sincerity as objectors is required to submit affidavits in support of exemption requests.194 detailed descriptions of the objector’s beliefs such as are required in illinois may also be viewed as an attempt to verify sincerity.195 assessments of sincerity are more difficult in the area of conscience than religion, as people may be unable to articulate the depth of a particular conviction and its importance in their lives or in comparison to other beliefs.196 as a result, there is no guarantee that examination of one’s behavior will provide clear resolutions with respect to personal motivations of the actor, sincerity, and establishment of a hierarchy of convictions.197 this difficulty is exacerbated by the likelihood that conscientious objectors are not affiliated with a religious congregation or ascribe to tenets, beliefs, and practices associated with a specific faith tradition. however, the absence of membership in a religious congregation may not be necessary for a valid religious objection.198 acceptance of vaccination by the objector’s religion also is not conclusive.199 the absence of required membership in a congregation, ascription to specific religious tenets and beliefs, and doctrinal conformity blurs the line 193. see, e.g., 28 pa. code § 23.84(b) (2022) (requiring objections to be supported by “religious grounds or on the basis of a strong moral or ethical conviction similar to a religious belief”). 194. see infra text accompanying notes 123, 126. but see infra text accompanying note 64. 195. see infra text accompanying notes 128-29. 196. see chapman, supra note 138, at 1478 (noting that “[s]ome people are remarkably ‘inarticulate’ about their motivation for acts of moral courage”). see also andrew koppelman, how shall i praise thee? brian leiter on respect for religion, 47 san diego l. rev. 961, 978 n.79 (2010) (discussing the inability of some people to clearly articulate the motivations for their behavior). 197. see kent greenawalt, the significance of conscience, 47 san diego l. rev. 901, 906 (2010) (questioning the reliability of even “a fairly intense examination” in distinguishing “genuine claims of conscience from lesser moral objections”). 198. see, e.g., maier v. besser, 341 n.y.s.2d 411, 413 (n.y. sup. ct. 1972) (granting an exemption from a required certificate of vaccination to a child of a parent who subscribed to christian scientist beliefs despite the absence of membership in the church). 199. see, e.g., berg v. glen cove city sch. dist., 853 f. supp. 651, 655 (e.d.n.y. 1994) (granting an exemption from vaccination to the child of a jewish parent based upon her sincere and genuine interpretation of hebrew scripture, despite the fact that the branch of judaism to which she subscribed did not oppose vaccination). for examples of acceptance of vaccination by specific faith traditions, see, e.g., nat’l catholic bioethics ctr., new charter for health care workers, arts. 69-70 (2017); geoffrey s. nelson, mormons and compulsory vaccination, mormon press (mar. 30, 2015), https://www.mormonpress.com/mormon_vaccination [https://perma.cc/tqy5-k5we]. for a general discussion of acceptance of vaccination by various religions, see reiss, supra note 35, at 1574-84 (discussing the acceptance of vaccination by christianity, judaism, and islam and the views of christian scientists and jehovah’s witnesses). 52 indiana health law review [vol. 20:23 between religious objections and conscience-based objections which also lack such attributes.200 current case law does not provide adequate guidance regarding the question of sincerity of belief with respect to conscience-based objections. opinions addressing exemptions in the context of public-school attendance primarily concern the issue of whether beliefs qualify as religious.201 another group of cases address purely religious questions from constitutional perspectives.202 courts are, in any event, institutionally ill-suited to make determinations regarding sincerity of beliefs.203 courts struggle with defining religion and conscience, let alone rejecting accommodations for lack of sincerity.204 distinguishing between sincere and insincere beliefs is a difficult task, as such determinations tend to be fact-specific and subjective.205 as noted by levin, “if religious beliefs can be personal and idiosyncratic, who can say that any particular person seeking a religious accommodation is lying or insincere, and on what basis?”206 the ubiquity of the internet and its proliferation of sources of information and misinformation regarding religion and vaccines further complicates any judicial inquiry into the issue of sincerity.207 200. critics have contended that the absence of these factors encourages individuals to cloak their philosophical objections to vaccination under the guise of religion. see, e.g., lobo, supra note 29, at 273-74 (concluding that “many objectors who claim ‘religious’ reasons are actually using religion as a proxy for a non-religious motive”); reiss, supra note 35, at 1586-87 (discussing socalled “fake religions”); tomsick, supra note 36, at 137 (noting that only dutch reformed congregations and faith-healing denominations such as christian scientists object to vaccination leaving one to wonder “who is actually pursuing religious exemptions to compulsory vaccination statutes”). 201. see, e.g., watkins-el v. dep’t of educ., wl 5867048, at *3 (e.d.n.y. oct. 7, 2016) (concluding that an objection to vaccination was genuine and sincere but did not stem from the objector’s islamic faith); caviezel v. great neck pub. sch., 701 f. supp. 2d 414, 418 (e.d.n.y. 2010) (concluding that objector’s belief in pantheism was genuine and sincere but not religious in nature); farina v. bd. of educ., 116 f. supp. 2d 503, 508 (s.d.n.y. 2000) (concluding that the objectors’ beliefs were not the product of their roman catholic faith but were “borrowed from outside sources” including information available on the internet). 202. see infra text accompanying notes 31, 33, 84, 125, 156. see also maricopa cty. health dep’t v. harmon, 750 p.2d 1364, 1370 (ariz. ct. app. 1987) (concluding that the denial of a requested exemption from vaccination for measles on the basis of religious belief was not a denial of religious freedom pursuant to the arizona constitution). 203. see levin, supra note 23, at 1222 (contending that determinations of sincerity of belief “call on judges to make assessments that they are not institutionally well-suited to make”). see also infra text accompanying notes 89-91. 204. see levin, supra note 23, at 1208. 205. id. see also flynn v. estevez, 221 so.3d 1241, 1247-52 (fla. dist. ct. app. 2017) (refusing to adjudicate a dispute between a member of the catholic church and church teachings regarding vaccination based upon the ecclesiastical abstention doctrine). 206. levin, supra note 23, at 1208. 207. see mahmoud-davis, supra note 76, at 241 (concluding that “the accessibility of the 2023] nonmedical exemptions to public school vaccination mandates 53 the same conclusion holds true for conscience-based beliefs to the extent that they parallel religion by drawing upon similar ideas, motivating similar behaviors and lifestyle choices, and serving as the basis for personal identity.208 levin also correctly concludes that the necessary case-by-case approach to assess sincerity would be cost prohibitive, not only for school administrators and health departments, but also for courts which would inevitably be required to review any finding of insincerity.209 conflicting outcomes would invariably result from such inquiries. this is not to contend that consideration of sincerity should be beyond administrative or judicial inquiry. the burden of proof regarding belief and sincerity remains with the individual seeking an exemption by a preponderance of the evidence.210 this inquiry may be narrower than in the case of religion, given the absence of indicia of belief, such as church membership, formal services, rituals, ceremonies, accepted texts, recognized clergy, holidays, and efforts at propagation.211 but such inquiry must nevertheless proceed.212 there are several factors which are relevant to the sincerity inquiry. lines of inquiry relating to the belief may include its sources, the level of detail, and its connection to the vaccination from which an exemption is sought.213 non-specific beliefs and standalone principles, bearing only a tangential relationship to vaccination, may be indicative of factors beyond the bounds of conscience such as mistrust of government, fear, and reliance upon misinformation.214 while maintaining some degree of rigor, administrators and courts should exercise caution in their assessments of the validity of individual beliefs.215 of equal importance are the objector’s words and actions.216 the impact of the belief upon daily routine, as manifested through health care decisions, diet, and other aspects of the objector’s lifestyle, may provide a window into internet and the proliferation of information about religion and vaccines makes the task of distinguishing between legitimate and fraudulent opt-out requests even harder”). 208. see levin, supra note 23, at 1207. 209. id. 210. see, e.g., farina v. bd. of educ., 116 f. supp. 2d 503, 508 (s.d.n.y. 2000); sherr v. northport-east northport union free sch. dist., 672 f. supp. 81, 94 (e.d.n.y. 1987). 211. see malnak v. yogi, 592 f.2d 197, 209 (3d cir. 1979) (adams, j., concurring) (recognizing the existence of a religion by external signs such as “formal services, ceremonial functions, the existence of clergy, structure and organization, efforts at propagation, observation of holidays and other similar manifestations associated with traditional religions”). 212. but see infra text accompanying note 161. 213. see mahmoud-davis, supra note 76, at 243. 214. see farina, 116 f. supp.2d at 513 (discussing the necessity of distinguishing between genuine beliefs and personal fears of vaccination). 215. see int’l soc’y of krishna consciousness v. barber, 650 f.2d 430, 441 (2d cir. 1981). 216. see farina, 116 f. supp. 2d at 508 (providing that government officials “may draw inferences from an [individual’s] words and actions in determining whether they hold genuine and sincere . . . beliefs against inoculations”). 54 indiana health law review [vol. 20:23 individual sincerity.217 inconsistent words and deeds, including consent to the administration of other vaccinations and medical interventions, may indicate a lack of sincerity.218 chronological considerations may also be critical to the determination of sincerity, specifically, the length of time that the individual has held the belief and whether such belief has changed over time.219 a final indication of non-sincerity is whether the objector began pursuit of a consciencebased exemption after the rejection of a medical or religious exemption. such behavior may be indicative of “exemption shopping.” evidence of sincerity may also exist when an individual suffers a negative consequence as a result of his or her belief, such as an adverse health condition or heightened risk thereof to him or herself or affected children, public condemnation, and exclusion from school. the willingness to voluntarily suffer such consequences demonstrates a degree of individual sincerity indicative of a conscience-based response and serves to distinguish it from instances in which an individual objects to a particular set of circumstances, but “lacks the moral strength to adhere to that conviction.”220 unwillingness to suffer “significant adverse consequences” casts doubt upon the honesty and depth of an individual’s convictions.221 d. exemptions in times of epidemics and outbreaks state statutes granting conscience-based exemptions identify two instances in which existing exemptions may be disregarded. these instances relate to epidemics and outbreaks of vaccine preventable disease.222 the most common exception is the occurrence of an outbreak of disease.223 the existence of an 217. see mahmoud-davis, supra note 76, at 243. 218. but see farina, 116 f. supp. 2d at 508; sherr v. northport-east northport union free sch. dist., 672 f. supp. 81, 91 (e.d.n.y. 1987) (recognizing inconsistency of beliefs with established dogma or orthodoxy of religion). see also infra text accompanying note 137. 219. see mahmoud-davis, supra note 76, at 243 (discussing the relevance of the objector’s past and current beliefs to the question of sincerity). 220. greenawalt, supra note 197, at 905-06. 221. id. 222. an “epidemic” is defined as “an increase, often sudden, in the number of cases of a disease above what is normally expected in that population in that area.” u.s. dep’t of health & hum. servs., ctrs. for disease control & prevention, introduction to epidemiology, epidemic disease occurrence 1 (2011). an outbreak “carries the same definition of epidemic but is often used for a more limited geographic area.” id. 223. see ariz. rev. stat. ann. § 15-873(c) (2022) (outbreaks of communicable vaccine preventable diseases as determined by state or local health authorities); ark. code ann. §§ 6-18702(d)(4)(c )(iv)(a)-(b) (2022) (outbreak); la. stat. ann. § 17:170(f) (2022) (outbreak); utah code ann. § 53g-9-304(1)(a)(iv) (2022) (outbreak); wis. stat. § 252.04(7) (2022) (“substantial outbreak” at schools or municipality of diphtheria, measles, mumps, pertussis, polio, rubella, tetanus, and other diseases specified by the state health department). 2023] nonmedical exemptions to public school vaccination mandates 55 epidemic or threat thereof is required in a smaller number of states.224 three states specifically limit exemptions to a list of vaccine preventable diseases.225 these exceptions closely track those applicable to religious exemptions.226 differences between statutes permitting states to disregard exemptions are substantial. epidemics and outbreaks have different definitions in medical parlance. these definitions may also be too narrow in the event of an immunological emergency. state and local officials may find their power unduly constrained to undertake measures to protect students and the public. affected populations may include those outside of the locality or state in question, given the ubiquity of modern travel and the obvious fact that contagions do not recognize county lines or state borders. there are also a number of states that have no explicit statutory provisions relating to the non-recognition of exemptions during outbreaks, epidemics, or emergencies.227 furthermore, the 224. see colo. rev. stat. § 25-4-908 (2022) (“danger of an epidemic”); n.d. cent. code § 23-07-17.1(6) (2022) (“danger of an epidemic” existing with respect to chickenpox, diphtheria, hepatitis a and b, meningococcal disease, mumps, polio, pertussis, rotavirus, rubella, and rubeola); tex. educ. code ann. § 38.001(f) (2022) (“in times of emergency or epidemic” as declared by the commissioner of public health). see also rhea v. bd. of educ., 171 n.w. 103, 105-06 (n.d. 1919) (prohibiting vaccination mandate for smallpox in the absence of an imminent or existing epidemic). but see booth v. bd. of educ., 70 s.w.2d 350, 352-53 (tex. app. 1934) (upholding the denial of admission to public school of children unvaccinated for smallpox despite the absence of an imminent or actual epidemic). ohio provides for an exception to exemptions in the case of an epidemic, but the exception is limited to varicella epidemics declared by the director of the state department of health. see ohio rev. code § 3313.671(c) (2022). 225. see infra text accompanying notes 41, 46. 226. for state statutes and regulations permitting disregard of religious exemptions in times of an outbreak; see, e.g., ill. comp. stat. § 5/27-8.1(8) (2022) (outbreaks or exposure to disease); mont. code ann. § 20-5-405(4) (2022) (students may be excluded if there is a risk of exposure or transmission); wyo. stat. ann. § 21-4-309(a) (2022) (outbreak as determined by state or county health authority); del. admin. code § 804(7.1.3) (2022) (exclusion from school if the division of public health declares an outbreak or a student has had or is at risk of exposure). see, e.g., ala. code § 16-30-3(1) (2022) (epidemic or immediate threat thereof); ky. rev. stat. ann. § 214.036 (2022) (epidemic in a given area which may, by emergency regulation issued by the cabinet for health and human services, require vaccination). but see haw. code § 11-157-5(c) (2022) (“danger or presence of an outbreak or epidemic”). for state statutes and regulations permitting disregard of religious exemptions in times of a public health emergency; see, e.g., iowa code § 139a.8(4)(b) (2022) (emergency or epidemic as determined by the state board of health and declared by the director of public health); md. code ann. educ. § 7-403(b)(1) (2022) (emergency or epidemic declared by secretary of health); mass. gen. laws ch. 76, § 15 (2022) (emergency or epidemic declared by department of public health). 227. states lacking explicit statutory provisions relating to the non-recognition of exemptions during outbreaks, epidemics, or emergencies are florida, indiana, kansas, missouri, nebraska, nevada, new hampshire, new mexico, oklahoma, oregon, pennsylvania, rhode island, south carolina, and south dakota. but see infra text accompanying notes 205-06 (discussing the adoption 56 indiana health law review [vol. 20:23 ability of authorities to respond to outbreaks and epidemics is under attack in some states.228 public emergency laws provide a unified approach to addressing exemptions during an epidemic or outbreak of disease. the model state emergency health powers act (“msehpa”) serves as a model for uniformization.229 drafted in the wake of the attacks of september 11, 2001, and amplified concerns about bioterrorism, msehpa is designed to be implemented during a public health emergency which was defined, in part, as “an occurrence or imminent threat of an illness or health condition that is believed to be caused by . . . the appearance of a novel or previously controlled or eradicated infectious agent.”230 this occurrence or imminent threat must present a “high probability” of a large number of deaths, serious or long-term disabilities, or widespread exposure posing a significant risk of substantial future harm.231 msepha authorizes public health authorities to vaccinate persons against infectious disease during a public health emergency and quarantine persons who are unable or unwilling to undergo vaccination for medical, religious, or philosophical reasons.232 the laws in numerous states either duplicate233 or closely of the model state emergency health powers act by florida, new mexico, oklahoma, oregon, south carolina, and south dakota). 228. see, e.g., h.b. 30, 2022 reg. sess. (ala. 2022) (eliminating the exception to exemptions in the event of an epidemic); h.b. 266, 32nd leg., first sess. (alaska 2022) (providing that the governing body of school districts may, rather than shall, order vaccination of students if the commissioner of health and social services deems it necessary for the welfare of individual students or the general public); h.b. 2281, 55th leg., second reg. sess. (ariz. 2022) (providing that students may be excluded from public schools only if there is an active case of vaccine preventable disease within the school and the department of health services or local health department declares an outbreak in the area including the school). see also infra text accompanying note 88. but see doe v. san diego unified sch. dist., 19 f.4th 1173, 177-82 (9th cir. 2021) (concluding that an individual’s belief that covid-19 vaccines were derived from fetal stem cells was insufficient to avoid vaccination mandate); masseth v. jones, 2021 wl 6752317, at *13 (c.d. cal. nov. 9, 2021) (concluding that administration of the pertussis vaccine was rationally related to the protection of student health and an incidental burden on religion); s.b. 153, 2021-22 leg. sess. (vt. 2022) (eliminating religious exemptions to vaccination in public schools). 229. lawrence o. gostin, proposed draft: the model state emergency health powers act (hereinafter “msepha”)., ctr. for law & pub’s health georgetown & johns hopkins univs. (oct. 23, 2001), https://biotech.law.lsu.edu/blaw/bt/msehpa.pdf [https://perma. cc/mln2-6wcb]. 230. msepha, § 104(m)(1)(ii). for a discussion of the factors motivating the drafting of msepha, see horowitz, supra note 83, at 1728. 231. msepha, §§ 104(m)(2)(i)-(iii). 232. id. §§ 603(a)(1)-(3). 233. see, e.g., ala. code § 31-9-3(4) (2022); del. code ann. tit. 20, §§ 3132(11) (a)-(b) (2022); ga. code ann. § 31-12-1.1(2) (2022); iowa code § 135.140(6) (2022) (referring to a “public health disaster”); la. stat. ann. § 29:762(12) (2022); n.j. stat. ann. § 26:13-2 (2022); okla. stat. tit. 63, §§ 6104(2)(a)-(b) (2022); or. rev. stat. §§ 433.442(4)(a)-(b) (2022); wis. 2023] nonmedical exemptions to public school vaccination mandates 57 track msepha’s public health emergency language.234 a smaller number of states endorse msepha’s vaccination provision.235 adopting msepha’s provisions into state laws granting exemptions has several advantages. msepha is non-controversial, as demonstrated by its wide acceptance by numerous states recognizing nonmedical exemptions, including seven states which currently recognize conscience-based exemptions.236 utilization of msepha’s emergency standard is broader than the epidemic and outbreak standards currently in use in many states. this breadth empowers state and local health departments and officials to act prior to the occurrence of an outbreak or epidemic, by which time efforts to contain disease may be too late.237 msepha’s emergency standard narrows exemptions during times of exigency. this narrowing recognizes that exemptions are intended to be the exception to universal school vaccination and not the rule. to allow objectors to dictate the terms of state and local responses to outbreaks and epidemics is inconsistent with public and school health considerations. states are under no legal obligation to grant nonmedical exemptions and, in so doing, are free to set stat. §§ 323.02(16)(a)-(b) (2022); wyo. stat. ann. § 35-1-115(a)(1) (2022) (referencing “a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability”). 234. see, e.g., ariz. rev. stat. ann. § 36-787(a) (2022) (defining a state of emergency as “an occurrence or imminent threat of an illness or health condition that is caused by . . . an epidemic or pandemic disease . . . that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability”); fla. stat. § 381.003315(1)(c) (2022) (defining a public health emergency to include any occurrence or threat “which results or may result in substantial injury or harm to the public health from infectious disease”); 20 ill. comp. stat. § 3305/4 (2022) (defining a “disaster” to include “an occurrence or threat of widespread or severe damage, injury or loss of life . . . resulting from . . . [an] epidemic”); ind. code § 10-14-31(b)(22) (2022) (defining a “disaster” to include “an occurrence or imminent threat of widespread or severe damage, injury or loss of life . . . resulting from . . . [an] epidemic”). 235. see, e.g., fla. stat. § 381.003315(1)(d)(4) (2022) (empowering the state health officer to order vaccinations for “communicable diseases that have significant morbidity or mortality and present a severe danger to public health”); ga. code ann. § 31-12-3(a) (2022) (authorizing the georgia department of public health and county boards of health to mandate vaccination against “contagious or infectious disease where the particular disease may occur, whether or not the disease may be an active threat”); 20 ill. comp. stat. § 3305/4 (2022) (authorizing the state department of public health to order the administration of vaccines “as necessary to prevent the probable spread of a dangerously contagious or infectious disease”); iowa code § 135.144(6) (2022) (empowering the iowa department of public health to order vaccination against “an infectious disease and to prevent the spread of communicable or potentially communicable disease”). 236. see infra text accompanying notes 205-07. 237. see aspinwall, supra note 72, at 136 (contending that vaccination mandates in the event of an epidemic are of “limited utility because the disease already has spread by the time symptoms appear”). see also tomsick, supra note 36, at 137 (noting that “vaccinations are preventative health measures; once an outbreak exists, is it not too late to vaccinate?”). 58 indiana health law review [vol. 20:23 the terms by which they are granted.238 the non-recognition of exemptions in times of emergency is a reasonable limitation upon a privilege which states are not constitutionally compelled to grant. e. transparency a final strategy for addressing nonmedical exemptions is transparency. transparency serves as “a tool increasingly used in modern administrative states to achieve goals.”239 in the context of school vaccination, transparency “focuses on publicizing information regarding non-vaccination [sic], identifying children who are unvaccinated, and perhaps also publishing rates of vaccination of individual schools or other facilities, and localities.”240 transparency serves two important goals. first, publication of information regarding vaccination rates and the number of unvaccinated children allows parents to make informed decisions about where their children can safely attend school.241 informed decisions promote not only children’s health, but also benefits society, as the impact of unvaccinated individuals in the community may have a negative impact on public health.242 second, transparency provides valuable information to non-governmental organizations and health care providers, which may prove useful to their efforts to increase vaccine uptake in the communities they serve.243 an added benefit is the potential stigmatizing impact of such information, and resultant social pressure to conform individual behavior to accepted social norms.244 however, care needs to be exercised in order to avoid a backlash among vaccine resistant and hesitant parents, and maintain confidentiality of medical and educational records.245 states have taken different approaches to transparency. some states expressly require schools, officials, or districts to retain documents relating to exemptions.246 although the aggregation of information is undoubtedly important 238. see infra text accompanying notes 80-85. 239. reiss & weithorn, supra note 25, at 973. 240. id. at 963. 241. see tomsick, supra note 36, at 136 (citing caitlin cardenas-comfort & mary majumder, laws about transparent school vaccination reporting: public health context & ethics, 109 am. j. pub. health 1687, 1688 (2019)). 242. see tomsick, supra note 36, at 136. 243. id. 244. see reiss & weithorn, supra note 25, at 963 (contending that such stigmatization may “exert influence on the conduct of some who might otherwise avoid vaccination”). see also infra text accompanying note 148. 245. see reiss & weithorn, supra note 25, at 973 (discussing and rejecting the “extreme” approach of publicizing the names of all unvaccinated children attending school and their parents which would alert others of the risk of contact with such individuals and allow them to undertake self-protective measures). 246. see, e.g., ga. code ann. § 20-2-771(e) (2022) (requiring filing of documents relating to 2023] nonmedical exemptions to public school vaccination mandates 59 to schools, school districts, and state health and educational agencies, it is of far less use to individuals and health care providers, to the extent it cannot be shared due to privacy considerations. this approach also requires parties to be proactive in seeking out information shared with the public. individuals need to be knowledgeable about the sources of information and how to access it. procedures for obtaining information may prove cumbersome and confusing for inexperienced individuals. the same criticisms hold true for states requiring the filing of annual reports with administrative bodies.247 the preferable approach to transparency is one in which school districts and officials actively engage interested parties. such an approach is found in colorado’s procedures governing the granting of exemptions. colorado’s certificate seeking an exemption requires the gathering of significant amounts of information, including the identities of the parents and students, the names and locations of the schools that the students are attending, and the vaccines for which an exemption is sought.248 the state is specifically prohibited from requiring identification of the religious faith or reason for seeking a conscience-based exemption.249 the state is also prohibited from storing any such information.250 however, school districts are required to annually disclose to all parents the exemption rates for measles, mumps, rubella, and any other required vaccinations in the school’s discretion.251 exemption information thus reaches even the most passive of parents, does not require active searches, maintains the privacy of persons seeking exemptions, and protects them from stigmatization. in this manner, parents may make informed choices about school attendance for their children, and non-governmental organizations and health care providers may target communities lagging in vaccine uptake to the detriment of public health and well-being. vii. conclusion the covid-19 pandemic has brought renewed attention to issues religious exemptions with the “responsible official of the school or facility”); ind. code § 20-34-32(a)(3) (2022) (requiring delivery of documents seeking a religious exemption to a teacher or other person who may order vaccination); nev. rev. stat. § 392.437 (2022) (providing for filing of a written statement seeking a religious exemption with the board of trustees of the local school district); r.i. gen. laws § 16-38-2(a) (2022) (requiring retention of documents seeking religious exemptions by the administrative head of the school). 247. see, e.g., minn. stat. § 121a.15(3)(d) (2022) (requiring school administrators to forward exemption requests to the commissioner of the state department of health); md. code regs. § 10.06.04.05(c)-(d) (2022) (requiring schools to maintain a list of exempted students and annually report the number of exemptions to the secretary of health). 248. see colo. rev. stat. §§ 25-4-903(2.3)(b)(ii)(a), (b)(iii) (2022). 249. id. § 25-4-903(2.3)(b)(v). 250. id. 251. see 6 colo. code regs. §§ 1009-2-xiv(c)(1)-(2) (2022). 60 indiana health law review [vol. 20:23 surrounding vaccination, which have smoldered for decades. skepticism regarding the efficacy of vaccination requirements has thrived among a small but vocal portion of the population. controversy swirls around questions of individual autonomy versus contributing to the collective good and the political weaponization of vaccination in an increasingly divided nation.252 in such a highly polarized society, vaccination has become an additional log on the cultural fires that have consumed the country in recent years. successful public health policies rely heavily on a substantial degree of voluntary cooperation.253 the underlying assumption in a cooperative approach is that policies are consistent with social attitudes and values.254 while there is strong support for required vaccination as a condition of public school attendance, the consistency of such support with social norms may depend upon factors beyond health considerations.255 every state has compelled cooperation through mandates, but these coercive policies have promoted work-arounds in the form of nonmedical exemptions.256 despite the criticism of nonmedical exemptions as a surrender of public health to the control of a minority who refuse vaccination, and the conclusion that they are not legally required, the elimination of nonmedical exemptions is unrealistic.257 the recognition of this reality by public health authorities and school administrators, sooner than later, is the preferable course. this recognition does not mean that those responsible for the health and safety of students and the general public must surrender their authority to those who oppose vaccination for whatever reason. instead, state and local officials must act to discourage, if not actively impede, exemptions through enhanced procedural rigor, counseling and persuasion, assessment of good faith and sincerity, and the exercise of emergency powers in appropriate circumstances.258 greater transparency empowers parents to make appropriate choices for their children in often uncertain circumstances.259 this article proposes methods by which to achieve these goals utilizing existing state law. for better or worse, nonmedical exemptions are a fixture of current health and education law. but the vast majority of those who support 252. see infra text accompanying notes 26-27, 67-71. 253. see reiss & weithorn, supra note 25, at 955 (contending that “[p]ublic health policy success typically depends on a substantial degree of voluntary cooperation”). see also lawrence o. gostin et al., the law and the public’s health: a study of infectious disease law in the united states, 99 colum. l. rev. 59, 120 (1999). 254. reiss & weithorn, supra note 25, at 955. 255. see, e.g., grace sparks et al., kff covid-19 vaccine monitor: profile of the unvaccinated, kaiser family found. (june 11, 2021), https://www.kff.org/coronavirus-covid19/poll-finding/kff-covid-19-vaccine-monitor-profile-of-the-unvaccinated/ [https://perma.cc/568t6v5q] (finding significant differences in vaccination rates and willingness to be vaccinated depending upon race, gender, age, education, income, geographic location, and political affiliation). 256. see infra text accompanying notes 32-52. 257. see infra text accompanying notes 65, 80-88. 258. see infra text accompanying notes 115-210. 259. see infra text accompanying notes 211-23. http://www.westlaw.com/link/document/fulltext?findtype=y&sernum=0110707930&pubnum http://www.westlaw.com/link/document/fulltext?findtype=y&sernum=0110707930&pubnum 2023] nonmedical exemptions to public school vaccination mandates 61 universal vaccination of children as a condition of public-school attendance are not powerless. rather, it is best to accept what cannot be changed, act to limit that which already exists, and prevent further erosion of the benefits associated with vaccination. in so doing, the interests of current public-school students and future generations may best be protected. fda preemption: pros, cons, & a path forward for public health in the 21st century indiana health law review volume xxii 2025 number 1 articles fda preemption: pros, cons, & a path forward for public health in the 21st century jordan jekel * introduction in the modern era, the food and drug administration (“fda”) serves a public health role in protecting the public from products that fail to meet safety and efficacy standards and by promoting health through making healthy and aidful drugs, food, and devices available, along with the necessary information to use those products. 1 given the broad intersection of health regulation from the federal government and the states, preemption greatly affects public health. 2 as federal regulation of health grows more expansive, preemption doctrine becomes more important. 3 there is a delicate balance of state and federal health regulation within the “healthcare federalism” framework. 4 a recently passed california state law exemplifies how fda preemption may conflict with state requirements. in october 2023, california passed the california food safety act, which banned four harmful food and drink ————————————————————————————— * jordan jekel graduated from the university of maryland francis king carey school of law in may 2024. during law school, she served as editor-in-chief of the journal of health care law & policy and as a student attorney in the public health law clinic. she is currently working in big law through the legal innovators program. jordan thanks professor frank palumbo for his feedback in the development of this article. she also thanks professors paula monopoli and kathi hoke for their mentorship and guidance. this article does not reflect the views of the author’s employer, legal innovators, or the author’s supervising law firm. 1. patricia j. zettler, pharmaceutical federalism, 92 ind. l.j. 845, 857 (2017). 2. lawrence o. gostin, the fda, preemption, and public safety: antiregulatory effects and maddening inconsistency, hasting ctr. rep. 11, 11 (2011), https://scholarship.law.georgetown. edu/facpub/695 [https://perma.cc/cnl5-tx7g]; elizabeth y. mccuskey, body of preemption: health law traditions and the presumption against preemption, 89 temple l. rev. 95, 96-97 (2016). 3. mccuskey, supra note 2, at 97–98; christine a. gaddis, buckman extended: federal preemption of state fraud-on-the-fda status, 69 food & drug l.j. 113, 114 (2014) (citing medtronic, inc. v. lohr, 518 u.s. 470, 475 (1996)). 4. allison m. whelan, the preemption prescription: combatting health disparities caused by state pharmaceutical restrictions, harv. advanced leadership initiative soc. impact rev. (nov. 8, 2022), https://www.sir.advancedleadership.harvard.edu/articles/preemptionprescription-combatting-health-disparities-caused-by-state-pharmaceutical-restrictions [https:// perma.cc/4c5m-dh4w]. https://www.sir.advancedleadership.harvard.edu/articles/preemption https://perma.cc/cnl5-tx7g https://scholarship.law.georgetown indiana health law review [vol. 22:1 2 additives. 5 the restriction will begin in 2027. 6 currently, all four banned additives are approved by the fda for usage in food. 7 many producers are already signaling that they will adapt recipes to california standards, inherently benefitting consumers across the country. 8 but, time will tell if other companies choose to challenge the law on an impossibility preemption basis, using stopsell rationale. 9 this matter illustrates the constantly evolving and pressing necessity of understanding how fda preemption affects public health. to address this potential preemption conflict, and other preemption issues moving forward, it may be most prudent for the fda to argue that there is a presumption in favor of preemption when the agency conducted an informed risk-benefits analysis pre-approval and no new information or considerations are available. 10 part i will address the history and development of federal preemption doctrine, including the different types of preemption and the growth of agency preemption. 11 part ii will cover the history of fda preemption and how it evolved over time, starting with the origination of the fda and its initial preemption powers. 12 then, part ii will discuss fda preemption in the modern era, including the drug versus device distinction and examples of fda preemption over the last thirty years. 13 part iii discusses the advantages, from a public health lens, of pursuing an “aggressive” versus a “deferential” fda preemption strategy. 14 additionally, part iii will analyze three current public health matters to focus the preemption discussion: opioids, obesity, and abortion. 15 part iv will provide a recommendation for how fda should pursue preemption strategies in the future to best support public health. 16 finally, part v will provide a conclusion.17 ————————————————————————————— 5. joe hernandez, california becomes the first state to ban 4 food additives linked to disease, npr (oct. 10, 2023, 1:05 pm), https://www.npr.org/2023/10/10/1204839281/california-banfood-additives-red-dye-3-propylparaben-candy [https://perma.cc/men8-kjmx]. 6. id.; katharina buchholz, the products affected by the california food additives ban, forbes (nov. 3, 2023, 10:51 am), https://www.forbes.com/sites/katharinabuchholz/2023/10/ 13/the-products-affected-by-the-california-food-additives-ban-infographic/?sh=3ccb564e6b7d [https://perma.cc/2lst-xu4v]. 7. hernandez, supra note 5. 8. see infra section ii.b.2. 9. see infra section ii.b.2. 10. see infra part iv. 11. see infra part i. 12. see infra part ii. 13. see infra part ii. 14. see infra part iii. 15. see infra part iii. 16. see infra part iv. 17. see infra part v. https://perma.cc/2lst-xu4v https://www.forbes.com/sites/katharinabuchholz/2023/10 https://perma.cc/men8-kjmx https://www.npr.org/2023/10/10/1204839281/california-ban 2025] fda preemption 3 i. history & development of federal preemption doctrine a. how federal preemption doctrine developed over time preemption is implicated when, inevitably, state and federal laws overlap. 18 the united states constitution provides that where a federal law and state law conflict, the federal law prevails. 19 this federal preemptive power arises from the supremacy clause. 20 when preemption occurs, the state law is effectively displaced. 21 courts do traditionally try to find a “presumption against preemption” when evaluating potentially conflicting federal and state legislation, particularly when a federal law is regulating within the traditional state police powers. 22 these police powers include regulation of health and safety. 23 despite the state hold over police powers, courts do sometimes find that federal laws preempt state health laws, for example, when the purpose of congress, “‘the ultimate touchstone’ in determining the scope of preemption,” so requires. 24 b. overview of the types of preemption a state law is expressly preempted by a federal law when congress “explicitly state[s] its intent to preempt state law” in the legislation. 25 congress is clearly authorized by the constitution to preempt state authority through express statement. 26 however, when a federal law directly and expressly preempts in an area considered a traditional state police power, the supreme ————————————————————————————— 18. caleb nelson, preemption, 86 va. l. rev. 225, 225 (2000). 19. gibbons v. ogden, 22 u.s. 1, 129 (1824); tamsen valoir & shubha ghosh, fda preemption of drug and device labeling: who should decide what goes on a drug label, 21 health matrix 555, 559 (2012). 20. u.s. const. art. vi, § 2; see also chi. & n.w. transp. co. v. kalo brick & tile co., 450 u.s. 311, 317 (1981) (stating supremacy clause is root of preemption doctrine). 21. maryland v. louisiana, 451 u.s. 725, 746 (1981). 22. cipollone v. liggett grp., inc., 505 u.s. 504, 516, 518 (1992); valoir & ghosh, supra note 19, at 560; see also cal. v. ferc, 495 u.s. 490, 497 (1990) (“just as courts may not find state measures pre-empted in the absence of clear evidence that congress so intended, so must they give full effect to evidence that congress considered, and sought to preserve, the states' coordinate regulatory role in our federal scheme.”); altria grp., inc. v. good, 555 u.s. 70, 77 (2008) (explaining how state police powers impact the court’s analysis). 23. valoir & ghosh, supra note 19, at 560. 24. thomas a. costello, quitting cold turkey: federal preemption doctrine and states bans on fda-approved drugs, 26 wm. & mary bill rts. j. 839, 845 (2018) (quoting medtronic, inc. v. lohr, 518 u.s. 470, 485 (1996)); buckman co. v. plaintiffs’ legal comm., 531 u.s. 341, 347 (2001). 25. leslie c. kendrick, fda’s regulation of prescription drug labeling: a role for implied preemption, 62 food & drug l.j. 227, 228 (2007) (citing jones v. rath packing co., 420 u.s. 519, 525 (1977)). 26. pac. gas & elec. co. v. state energy res. conservation & dev. comm’n, 461 u.s. 190, 203 (1983). indiana health law review [vol. 22:1 4 court requires a narrow reading.27 while not explicit, implied preemption also can block a state law. implied preemption takes on two forms: field or conflict. federal courts may find field preemption “when an act of congress touches ‘a field in which the federal interest is so dominant that the federal system …’” assumedly precludes any state law enforcement “on the same subject.” 28 this may occur when a federal interest in a particular field is so controlling that the federal law “preclude[s] enforcement of state laws on the same subject.” 29 for example, in rice v. santa fe elevator corp., the supreme court found that a congressional statute which set federal requirements over grain storage preempted state laws governing similar grain warehouse practices because “[t]he scheme of federal regulation [was] so pervasive” that it is reasonable to infer “that congress left no room for the states to supplement it.” 30 conflict preemption occurs “when there is outright or actual conflict between federal and state law.” 31 conflict preemption either qualifies as impossibility preemption or obstacle preemption. 32 impossibility preemption occurs when complying with both the state and the federal law is physically impossible. 33 this doctrine is illustrated in mutual pharmaceutical co. v. bartlett. 34 in mutual pharmaceutical, the supreme court found that because new hampshire’s design defect claims conflicted with a federal law that precludes generic drug manufacturers from making label changes, it was impossible to comply with both laws, thus, requiring preemption of the state law. 35 obstacle preemption occurs when a state law creates “an obstacle to the accomplishment and execution of the full purposes and objectives of congress.”36 for example, in crosby v. national foreign trade council,37 the supreme court preempted a massachusetts law that prohibited state citizens from buying any goods or services from myanmar providers. 38 the court reached decided to apply preemption because the state law conflicted with a ————————————————————————————— 27. nelson, supra note 18, at 291 (quoting cipollone, 505 u.s. at 518); see also medtronic, inc., 518 u.s. at 485 (reasserting narrow preemption reading when in arena of police powers). 28. valoir & ghosh, supra note 19, at 562 (citing rice v. santa fe elevator corp., 331 u.s. 218, 230 (1947)). 29. nelson, supra note 18, at 227 (quoting rice, 331 u.s. at 230). 30. 331 u.s. at 224–27, 230, 237. 31. la. publ. serv. comm’n v. fcc, 476 u.s. 355, 368 (1986). 32. nelson, supra note 18, at 228. 33. fla. lime & avocado growers, inc. v. paul, 373 u.s. 132, 142–43 (1963). 34. 570 u.s. 472 (2013). 35. id. at 479-80; see also jamie kendall et al., fda preemption and albrecht’s progeny, 76 food & drug l.j. 579, 579 (2022). new hampshire argued that the tort liability created a positive duty for manufacturers to create safe products. mut. pharm., 570 u.s. at 481. 36. hines v. davidowitz, 312 u.s. 52, 67 (1941); see also nw. cent. pipeline v. state corp. comm’n of kan., 489 u.s. 493, 509 (1989) (“in the absence of explicit statutory language signaling an intent to pre-empt, we infer such intent . . . because the state law stands as an obstacle to the accomplishment and execution of congressional objectives . . . ”). 37. 530 u.s. 363 (2000). 38. id. at 388. 2025] fda preemption 5 federal act that gave the president power to implement sanctions and created an obstacle for the president in executing his duties. 39 c. the development of agency preemption preemption also extends to agency action. 40 agencies are able to preempt state law when they act within the scope of the authority delegated to the agency from congress. 41 further, the supreme court determined that when an agency makes specific determinations based on a comprehensive analysis of risks, express and implied preemption may require overriding state law. 42 for example, in williamson v. mazda motor of america, the supreme court rested its analysis of whether a federal safety regulation preempted a state tort action primarily on the agency’s interpretation of its preemptive force. 43 of note, agency preemption is often used as a defense against state tort claims.44 geier45 addressed this issue and set the stage for the current agency preemption doctrine. 46 in geier, the plaintiff sued honda, the defendant, after getting seriously injured in an accident while driving a honda automobile. 47 the plaintiff argued that the negligent design of the car, specifically, the lack of a driver side airbag, made honda liable. 48 honda argued that the national traffic and motor vehicle safety act, which congress enacted specifically to outline vehicle safety measure requirements, preempted the plaintiff’s claim. 49 the supreme court found that the department of transportation safety regulations, arising from this act, preempted state tort actions against manufacturers who failed to install airbags. 50 the court reached this decision through conflict preemption analysis—if the state tort remedy prevailed, the department’s comprehensive regulation could not have accomplished its full purpose. 51 ————————————————————————————— 39. id. 40. see la. pub. serv. comm’n v. fcc, 476 u.s. 355, 369 (1986) (explaining that “federal agency acti[on] within the scope of its congressionally delegated authority may pre-empt state regulation.”). 41. n.y. v. fed. energy regul. comm’n, 535 u.s. 1, 18 (2002). 42. kendrick, supra note 25, at 240-41; see generally geier v. am. honda motor co., 529 u.s. 861 (2000). 43. catherine m. sharkey, inside agency preemption, 110 mich. l. rev. 521, 524 (2012) (citing williamson v. mazda motor of am., inc., 562 u.s. 323, 330 (2011)). 44 . see, e.g., silkwood v. kerr-mcgee corp., 464 u.s. 238, 256 (1984) (finding no preemption of state tort law claims against nuclear facility, even though federal government regulates nuclear safety). 45. 529 u.s. 861 (2000). 46. sara rosenbaum, wyeth v. levine: implications for public health policy and practice, 125 pub. health reps. 494, 494–95 (2010). 47. geier, 529 u.s. at 865. 48. id. 49. id.; costello, supra note 24, at 850. 50. geier, 529 u.s. at 864–65, 867. 51. id. at 867, 869–75. indiana health law review [vol. 22:1 6 ii. history of fda preemption & evolution over time a. original fda preemption powers under the federal food, drug, and cosmetic act of 1938 congress established the fda through the pure food and drug act of 1906 and supplemented the agency’s responsibilities with the federal food, drug, and cosmetic act (“ffdca”) in 1938.52 the ffdca created greater regulation of drugs and food on a national scale, with a focus on safety, effectiveness, and proper labeling. 53 originally, the ffdca did not include an express preemption provision. 54 pursuant to the national uniform nutrition labeling 55 and safe medical device amendments, 56 fda is now granted express preemption authority over inconsistent state law requirements. 57 beyond this express preemptive power, like other federal agencies, the fda also has extensive implied preemptive authority through the supremacy clause and the commerce clause. 58 when discussing fda preemption, it is important to understand that fda’s jurisdiction covers medical products, not the practice of medicine (which is a distinct area of regulation reserved for the states). 59 b. fda preemption in the modern era traditionally, fda is willing to work with states to avoid preemption where possible. 60 in the past, the fda only pursued preemption in cases not involving ————————————————————————————— 52. milestones in u.s. food and drug law, fda (jan. 30, 2023), https://www.fda.gov/ about-fda/fda-history/milestones-us-food-and-drug-law. 53. valoir & ghosh, supra note 19, at 563–64; mccuskey, supra note 2, at 133 (“the fda oversees the testing, approval, labeling, and marketing of drugs, devices, radiation-emitting products, vaccines, blood, biologics, animal and veterinary food, drugs, cosmetics, tobacco products, and supplements.”); see also u.s. const. art. i, § 8, cl. 3 (giving congress the authority to regulate interstate sales through the commerce clause, which may include sale of food and drugs). 54. 21 u.s.c. § 301. 55. id. § 343-1. 56. id. § 360(k). 57. food & drug l. inst., a practical guide to fda’s food and drug law and regulation 83–84 (stephen m. kanovsky & wayne l. pines eds., 7th ed. 2020) [hereinafter a practical guide]. 58. id.; see also u.s. const. art. i, § 8, cl. 3; u.s. const. art. vi, § 2. 59. zettler, supra note 1, at 849 (“the ‘crucial distinction between product and practice regulation’ is the cornerstone of federalism in pharmaceutical regulation. . . . [c]ourts, lawmakers, and [fda] itself have long opined that state jurisdiction is reserved for medical practice—the activities of physicians and other health care professionals—and federal jurisdiction for medical products, including drugs.”) (quotations omitted). 60. a practical guide, supra note 57, at 83–84; kendrick, supra note 25, at 231 (stating that the fda historically “embraced state tort law as complementary to its regulatory mission”). https://www.fda.gov 2025] fda preemption 7 state tort liability. 61 for example, in jones v. rath packing co., 62 the fda submitted an amicus brief arguing for preemption over a state regulation that conflicted with a federal regulation. 63 in eli lilly & co., inc. v. marshall,64 the court found that the fda’s confidentiality practice preempted a state court order requiring disclosure of information protected under federal regulation. 65 the fda also relied on a floor-ceiling model of drug regulation—where fda regulations set the floor (the minimum) requirements and state tort suits set the ceiling (the maximum) for liability. 66 this aligns with the judiciary’s tradition of avoiding preemption of state tort laws where there is a lack of a comparable federal remedy.67 however, over time, the fda seems more eager to pursue preemption. 68 for example, during the bush administration, the fda started to assert that certain state laws which add or differ from the federal medical product requirements are preempted. 69 additionally, in 2006, fda stated in a preamble to a final rule on prescription drug package inserts that the fda prescription drug labeling preempts state failure-to-warn claims in some scenarios. 70 while the fda stated this is a long held position, this regulation marked the first time that the agency so blatantly expressed a pro-preemption position. 71 the preemption position asserted by fda in this context is an implied preemption view.72 to support this position, the fda relies on its history of comprehensive drug labeling authority. 73 the fda further expressed concern that state law ————————————————————————————— 61. kendrick, supra note 25, at 231; but see buckman co. v. plaintiffs’ legal comm., 531 u.s. 341 (2001) (evaluating state “fraud on the fda” causes of action through a preemption lens). 62. 430 u.s. 519, 522 (1977). 63. id. at 522–24 (finding federal laws that regulate net weight labeling for meat packages preempt similar state regulations); see also grocery mfr. of am., inc. v. gerace, 755 f.2d 993 (2d. cir. 1985) (holding that federal regulation about descriptive cheese labeling, arising from ffdca, preempts state cheese imitation law because provisions are in direct conflict). 64. 850 s.w.2d 155, 158 (tex. 1993). 65. see generally id. 66 . michael r. abrams, renovations needed: the fda’s floor/ceiling framework, preemption, and the opioid epidemic, 117 mich. l. rev. 143, 152–53 (2018). 67. amanda frost, judicial review of fda preemption determinations, 54 food & drug l. j. 367, 375 (1999) (citing symens v. smithkline beecham corp., 152 f.3d 1050, 1055 (8th cir. 1998)). 68. kendrick, supra note 25, at 232. 69. a practical guide, supra note 57, at 97. 70. requirements on content and format of labeling for human prescription drug and biological products, 71 fed. reg. 3922, 3934 (jan. 24, 2006) (to be codified at 21 c.f.r. pts. 201, 314, 601) (“fda is the expert [f]ederal public health agency charged by congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading.”) whether or not the preamble declaration should receive judicial deference, is up for debate. see kendrick, supra note 25, at 233, 236. 71. kendrick, supra note 25, at 233, 227. 72. id. at 227. 73. id. indiana health law review [vol. 22:1 8 labeling requirements may lead to misbranding of a drug. 74 more recently, fda asserted statutory preemption in the skin protectant rule 75 and the bottled water rule. 76 the agency asserted that the skin protectant rule gives express preemption through 21 u.s.c. § 379r(a) and that the bottled water rule deserves preemptive effect through the misbranded food regulation of 21 u.s.c. § 403a.77 however, it is important to note that fda assertions are not law and are subject to potential challenges. in the modern era, fda preemption frequently arises in state failure-towarn cases. failure-to-warn claims are actions brought against drug manufacturers alleging that the manufacturer failed to provide adequate caution as to the risks of a certain drug that harmed a user (the plaintiff). 78 a manufacturer may use a preemption defense to defend its labeling choices when the state requirements conflict with the federal requirements for drug labeling. 79 1. drug versus device distinction in preemption current supreme court precedent reaches different preemption holdings with relation to drugs versus devices. broadly, federal labeling requirements do not preempt state tort claims against drugs, but federal labeling requirements do preempt state tort claims against medical devices. 80 this is a complicated area of fda preemption, because the supreme court is quite nuanced in its analysis. in under four years, the court ruled that state tort litigation against fda medical devices and stare failure-to-warn claims against generic drugs are preempted, while holding that state failure-to-warn claims against brand name drugs are not preempted. 81 the main difference between device regulation and the rest of the regulations under the ffdca is the express preemption provision 82—which is part of why the supreme court has issued varying preemption rulings for drugs versus devices. the primary example of this dichotomy is wyeth 83 versus riegel,84 as outlined further below.85 in the drug space, misbranding is a hot topic in fda preemption. one of the fda’s core functions is eliminating misbranding vis-à-vis making sure that ————————————————————————————— 74. 71 fed. reg. at 3935 (providing examples of types of state failure-to-warn claims that are preempted by fda labeling requirements). 75. 21 c.f.r. §§ 310, 347 (2009). 76. id. §§ 129, 165. 77. sharkey, supra note 43, at 548. 78. kendall et al., supra note 35, at 579. 79. id. (citing merck sharp & dohme corp. v. albrecht, 587 u.s. 299, 302–04 (2019)). 80. valoir & ghosh, supra note 19, at 555; see generally wyeth v. levine, 555 u.s. 555 (2009); riegel v. medtronic, inc., 552 u.s. 312 (2008). 81. gostin, supra note 2, at 11; see also wyeth, 555 u.s. 555; riegel, 552 u.s. 312; pliva, inc. v. mensing, 564 u.s. 604, 618 (2011). 82. 21 u.s.c. § 360k(a) (2012); valoir & ghosh, supra note 19, at 569. 83. wyeth, 555 u.s. 555. 84. riegel, 552 u.s. 312. 85. see infra notes 91–101, 109–13 and accompanying text. 2025] fda preemption 9 drugs are labeled properly and that drug advertising is truthful. 86 when a new drug is approved, the drug manufacturer and the fda work together to develop the drug label, with the fda giving final approval; if the manufacturer wants to change the label in the future, the agency must approve any substantive change.87 the wyeth case largely centered around the fda’s “changes being effected” (“cbe”) regulation. cbe allows a drug manufacturer to simultaneously bolster the safety language on a drug label before receiving fda approval and to notify the fda of the intended change. 88 a manufacturer may only utilize the cbe process if they knew or should have known about the newly acquired information, if the newly acquired information shows an association between an effect and the drug, and the casual association warrants adding a warning. 89 in practice, this cbe regulation is rarely used and typically only applies in emergency situations as a narrow exception for newly discovered risks.90 in wyeth v. levine, the plaintiff received phenergan, a drug for migraine treatment from wyeth (the defendant drug manufacturer). 91 if injected into an artery, phenergan may cause gangrene, a dangerous medical condition that can result in long-term injury. 92 when the plaintiff received her phenergan injection, the drug went into her artery, leading to gangrene and amputation. 93 the plaintiff consequently brought a negligence and strict liability lawsuit against wyeth, claiming that wyeth inadequately labeled the drug, leading to the injuries she received through the iv push method of injection. 94 wyeth argued that the plaintiff’s claims are preempted because it was impossible to modify phenergan’s label without violating federal law and because the “state tort action creates an unacceptable ‘obstacle to the accomplishment and execution of the full purposes and objectives of congress.’” 95 the supreme court held that a state failure-to-warn claim is not preempted unless the state law claims are clearly in tension with the ffdca. 96 wyeth represents a consumer-centric, anti-preemption approach. 97 despite the fda’s preamble asserting its preemptive effect over state failure-to-warn claims, the supreme court disagreed and “refused to defer to . . . fda’s position on ————————————————————————————— 86. 21 u.s.c. § 331(a), (b) (2006); valoir & ghosh, supra note 19, at 565. 87. kendall et al., supra note 35, at 580. 88. 21 c.f.r. § 314.70(c)(1)-(5) (2016). 89. kendall et al., supra note 35, at 582 (citing dolin v. glaxosmithkline l.l.c., 951 f.3d 882, 885 (7th cir. 2020)); see also 21 c.f.r. § 314.70(b)(2)(v)(a) (2016). 90 . valoir & ghosh, supra note 19, at 566–67 (citing background and proposed amendments, 73 fed. reg. 2850 (jan. 16, 2008) (to be codified at 21 c.f.r. pts. 314, 601, 814)). 91. wyeth v. levine, 555 u.s. 555, 559 (2009). 92. id. 93. id. 94. id. at 559–60. 95. id. at 563–64 (quoting hines v. davidowitz, 312 u.s. 52, 67 (1941). 96. kendall et al., supra note 35, at 580; see also wyeth, 555 u.s. at 581. 97. rosenbaum, supra note 46, at 496. indiana health law review [vol. 22:1 10 preemption.” 98 the court determined that the fda regulations create a floor, rather than a ceiling, for the required warnings. 99 impossibility preemption did not apply because, through the cbe process, wyeth could have changed the label unilaterally without the fda’s prior approval. 100 thus, the supreme court ultimately found that the state law presented no obstacle to the purpose of the ffdca, and thus, there is no preemption of state failure-to-warn suits against pharmaceuticals.101 medical device cases also shed light on preemption. for example, in cipollone, the supreme court determined that federal regulations preempted product liability claims against medical devices. 102 after the plaintiff’s mother, a smoker, died due to lung cancer, he sued a cigarette manufacturer for failureto-warn of the cigarette’s harm. 103 the defendant manufacturer argued that the public health cigarette smoking act, a federal statute, preempted the claims because the act requires a specific warning to appear on all cigarette packets. 104 the supreme court determined that the statute did indeed preempt the state law claims because congress considered preemption and explicitly included preemptive effect in the statute. 105 the medical device amendments of 1976 (“mda”), which amended the ffdca, added explicit language clearly granting fda preemptive powers over device regulations (akin to the public health cigarette smoking act in some respects). 106 the mda came in the wake of the dalkon shield crisis and at a time when some states had already enacted medical device regulations. 107 ————————————————————————————— 98. sharkey, supra note 43, at 546 (citing wyeth, 555 u.s. at 577); see also wyeth, 555 u.s. at 576–79 (determining that fda’s preamble asserting preemption is not persuasive because “it reverses the fda’s own longstanding position without providing reasoned explanation”). 99. wyeth, 555 u.s. at 575–76. 100. rosenbaum, supra note 46, at 496. 101. wyeth, 555 u.s. at 578, 581; see also valoir & ghosh, supra note 19, at 559–80 (describing court’s findings that congress consistently decided not to preempt state law through ffdca and that public policy requires holding drug companies accountable for their warning labels). 102. robert s. adler & richard a. mann, preemption and medical devices: the courts run amok, 59 missouri l. rev. 895, 904 (1994) (citing cipollone v. liggett grp., inc., 505 u.s. 504 (1992)); see also medtronic, inc. v. lohr, 518 u.s. 470 (1996). 103. cipollone, 505 u.s. at 508–09 . 104. id. at 508, 510. the act states: “no requirement or prohibition based on smoking and health shall be imposed under state law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this act.” 15 u.s.c. § 1334(b) (1988). 105. cipollone, 505 u.s. at 517; see also id. at 524 (“thus, insofar as claims under either failure-to-warn theory require a showing that respondents' post-1969 advertising or promotions should have included additional, or more clearly stated, warnings, those claims are pre-empted.”). 106 . 21 u.s.c. § 360k(a) (2012); leonard h. glantz & george j. annas, the fda, preemption, and the supreme court, 358 new eng. j. med. 1883, 1885 (2008). 107. valoir & ghosh, supra note 19, at 568–69. 2025] fda preemption 11 accordingly, congress included an express preemption clause in the mda. 108 in riegel v. medtronic, inc., the supreme court held that the express preemption clause of the mda preempts state law claims against the safety and efficacy of devices approved through the fda’s pre-market approval process. 109 the injured plaintiff argued that he had a case against medtronic, the device manufacturer, because the design, labeling, and manufacturing of the device violated new york law. 110 the supreme court determined that since the state common law claims imposed different requirements than the fda’s pre-market approval process to evaluate the safety and effectiveness of a device, preemption applied. 111 justice ginsburg issued a sole dissent in riegel. 112 she argued that because the medical device amendments were intended to improve public health by protecting from dangerous devices, congress could not have intended to take away the right of an injured patient to sue the manufacturer of a faulty device. 113 the dissent tracked closely with wyeth and the floor-ceiling model. 114 2. prime examples of fda preemption – 1990s to present as explained above, 115 state tort claims against medical devices are generally preempted by express preemption. 116 however, in medtronic, inc. v. lohr,117 the supreme court evaluated whether the medical device requirements from the fda preempt state law tort claims for injuries that arise from a medical device approved through the 510(k) process. the supreme court held that the requirements did not preempt the claims. 118 even though 510(k) relates to medical devices, the court determined that the manufacturing and labeling requirements fell outside the preemption provision. 119 coming out of ————————————————————————————— 108. 21 u.s.c. § 360k(a) (“[n]o state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”). 109. see generally riegel v. medtronic, 552 u.s. 312 (2008). 110. gaddis, supra note 3, at 118–19. 111. riegel, 552 u.s. at 330. 112. id. at 333–45 (ginsburg, j., dissenting). 113. glantz & annas, supra note 106, at 1885 (discussing j. ginsburg dissent in riegel). 114. see supra note 66–67 and accompanying text, discussing floor-ceiling model. 115. see generally supra section ii.b.1. 116. see, e.g., king v. collagen corp., 983 f.2d 1130 (1st cir. 1993) (determining mda preempted state law failure-to-warn claims against cosmetic medical device); martin v. medtronic, inc., 254 f.3d 573 (5th cir. 2001) (holding that because manufacturer complied with the fda’s “rigorous premarket approval procedure,” plaintiff’s “common law products liability tort claims are preempted by . . . the medical devices amendments”); rattay v. medtronic, inc., 482 f. supp. 2d 746 (n.d. w.v. 2007) (finding state strict liability, negligence, and failure-towarn claims against medical device (catheter) manufacturer preempted). 117. 518 u.s. 470 (1996). 118. id. 119. id. at 501. indiana health law review [vol. 22:1 12 medtronic, the court seemed to draw a line between general requirements— which are not preemptive—and specific determinations – which do carry a preemptive force. 120 next, in buckman co. v. plaintiffs’ legal comm., 121 the supreme court found that state fraud-on-the-fda claims are preempted by federal regulations through implied conflict preemption. 122 fraud-on-the-fda state statutes eliminate drug manufacturer protection from product liability when a plaintiff proves the manufacturer misrepresented data or information to the fda during the market approval process. 123 buckman involved class iii medical devices approved by the fda through the § 510(k) process. 124 the plaintiffs in this suit alleged that the manufacturer “made fraudulent representations to . . . the [fda]” when obtaining market approval and that the fraudulent representations gave rise to their injuries.125 in determining that the claims were preempted, the supreme court noted that the presumption against preemption is inapplicable in this case, despite dealing with health and safety, because the case “involve[s] the relationship between a federal agency and the entity it regulates.” 126 further, the court emphasized that these fraud-on-the-fda claims serve to potentially upset the careful balancing act done by the fda in approving such devices. 127 the state claims also could increase the burden on device applicants by potentially creating liability for manufacturers under the ffdca and each individual state scheme. 128 later, in pliva, inc. v. mensing,129 the supreme court found that despite wyeth, state failure-to-warn claims are preempted when brought against generic drug manufacturers, as the state cause of action directly conflicts with federal generic drug regulation. 130 in arguing before the court, the generic drug manufacturer asserted that it was impossible to comply with the state and federal labeling requirements, as each jurisdiction required different labels. 131 the court reasoned that since under the hatch-waxman act 132 generic manufacturers cannot unilaterally change a drug label through cbe, it would be impossible for a generic drug manufacturer to “simultaneously satisfy their state ————————————————————————————— 120. kendrick, supra note 25, at 240. 121. 531 u.s. 341 (2001). 122. id. at 348; see also gaddis, supra note 3, at 124 (outlining preemption decision, claim type, and outcome for major drug and device preemption cases in chart). 123. gaddis, supra note 3, at 113. 124. id. at 122. 125. buckman, 531 u.s. at 343. 126. gaddis, supra note 3, at 123 (quoting buckman, 531 u.s. at 347). 127. buckman, 531 u.s. at 348. 128. id. at 350. 129. 564 u.s. 604 (2011). 130. id. at 618, 626. 131 . peter grossi & daphne o’connor, fda preemption of conflicting state drug regulation and the looming battle over abortion medications, 10 j.l. & biosciences 1, 13 (2023). 132. 21 u.s.c. § 355(j). 2025] fda preemption 13 law duty to pro[vide] additional warning and their federal law duty to provide the same labeling as the brand name drug.” 133 the court solidified this decision in mutual pharmaceutical co. v. bartlett. 134 the plaintiff sued a generic drug manufacturer for injuries, allegedly due to unsafe drug design, since the drug label did not warn the plaintiff of the risk of a rare and serious condition she developed. 135 the court found impossibility preemption barred the design defect claims. 136 further, the court disregarded the plaintiff’s argument that impossibility could be avoided if the manufacturer just stopped selling its drug in the state as a means of compliance. 137 pliva receives criticism for making such a strong distinction between brand and generic drugs. this is because an individual’s ability to bring a failure-to-warn claim against a manufacturer will turn on whether the pharmacist dispensed a brand or generic name drug on the day in question.138 with generic drugs continually carving out a greater market share, preemption will likely overcome more consumer, state law claims over time. 139 as long as the hatch-waxman act stands as is, the court’s distinction between brand and generic name drugs is supported by federal law to some degree. 140 fda preemption also occurs when a state tries to enact less restrictive regulations than the fda. for example, in ouellette v. mills, 141 a federal district court judge found that federal law preempted a maine law that allowed patients to import unapproved drugs from specific countries. 142 congress gave the fda authority to inspect imported drugs and detain any drug that seems adulterated or in violation of united states drug regulations. 143 notably, maine (unsuccessfully) constructed its law to fall within the practice of medicine sphere, rather than product regulation. 144 an example of preemption in the food space arose from state food additive regulations. the ffdca requires the fda premarket approval of additive usage, but the fda’s final rule does not require notification about gras ————————————————————————————— 133. sharkey, supra note 43, at 551 (citing pliva, 564 u.s. at 606). 134. 570 u.s. 472 (2013). 135. id. at 478–79. 136. id. at 475, 485–87. 137. id. at 487–88. 138. gostin, supra note 2, at 12; see also abrams, supra note 66, at 162 (“consumers often play no role in the decision between a generic or brand-name drug that ends up impeding their path to recovery.”). 139. gostin, supra note 2, at 12 (“currently, the prescriptions for more than 90 percent of drugs for which a generic version exists are filled with generics.”). 140. 21 u.s.c. § 355(j). 141. 91 f. supp. 3d 1 (d. me. 2015). 142. zettler, supra note 1, at 848 (citing oullette, 91 f. supp. at 12). 143. 21 u.s.c. § 381(a). 144. jones v. rath packing co., 430 u.s. 519, 540–43 (1977); cosmetic, toiletry & fragrance ass’n, inc. v. minnesota, 440 f. supp. 1216, 1222 (d. minn. 1977), aff’d, 575 f.2d 1256 (8th cir. 1978). indiana health law review [vol. 22:1 14 substance use. 145 however, california enacted the sherman act, which only allowed limited quantities of added unsafe substances in food. 146 in sciortino v. pepsico, inc., 147 a federal court determined that because the relevant federal laws, the delaney clause and the color additives amendment, did not contain express preemption provisions, the state law could stand. 148 this case involved a california law that required an additional warning label, based on safety concerns, on products with certain color additives. 149 manufacturers raised preemption claims because the fda previously determined that the additive met a minimum safety threshold, though its ffdca authority. 150 the court reached this conclusion through relying on the presumption against preemption, bolstered by the fact that the state action fell within the realm of traditional police power regulations.151 most recently, in 2019, the supreme court addressed preemption of failureto-warn claims in merck sharp & dohme corp. v. albrecht. 152 albrecht built upon wyeth to set up a clearer standard for impossibility preemption analysis when analyzing pharmaceutical failure-to-warn claims: (1) determine if sufficient evidence exists to trigger the manufacturer’s ability to add the desired warning label to the product (unilaterally through cbe) and (2) if so, present “clear evidence … that fda would not have approved such changes.” 153 the plaintiff can only proceed if the manufacturer actually possessed the information needed to cure the labeling deficiency through cbe at the time the plaintiff took the drug.154 while the court did not reach a decision on the merits about whether preemption occurred, the majority did emphasize that preemption is a question of law that a court, rather than a jury, should determine. 155 iii. is it better to pursue an aggressive or deferential fda preemption strategy for public health? the fda contributes to public health by aiding in treatment and prevention of diseases and unsafe products through food and drug regulations. 156 there is ————————————————————————————— 145 . 21 c.f.r. § 170.30 (2024); laurie j. beyranevand & diana winters, retooling american foodralism, 44 am. j.l. & med. 489, 500–01 (2018). 146. beyranevand & winters, supra note 145, at 501 (citing cal. health & safety code §§ 110545–110655 (west 1970)). 147. 108 f. supp. 3d 780 (n.d. cal. 2015). 148. id. at 805–06 (citing 21 u.s.c. §§ 379e(b)(5)(b), 379e(a)). 149. beyranevand & winters, supra note 145, at 501. 150. id. 151. id. at 501–02. 152. 587 u.s. 299 (2019). 153. kendall et al., supra note 35, at 580, 582 (citing albrecht, 587 u.s. at 307-11). 154. id. at 589–90. 155. albrecht, 587 u.s. at 307–09. 156. mccuskey, supra note 2, at 129, 131. 2025] fda preemption 15 an ongoing debate as to what degree of preemption best serves public health. 157 looking at the advantages of various preemption strategies, as well as the effect of preemption on current public health issues, can shed light on how to approach fda preemption moving forward. but, it is important to note that to adopt either strategy, certain federal statutory changes may be necessary. a. advantages of pursuing an aggressive fda preemption strategy a main benefit of preemption is that it creates national uniformity across drug, device, and food regulations. 158 with greater federal preemptive force, states will likely be less inclined to try to enact contradictory or supplementary state laws. uniformity may also increase innovation and access, 159 as without the fear of litigation, drug manufacturers may be more willing to try out new products and less likely to increase prices. additionally, uniformity can decrease health disparities that arise when certain states enact regulations that impact access. 160 preemption may serve as a greater protector than litigation, because litigation rarely is corrective or additive to safety. 161 even if an aggressive preemption strategy is utilized, this does not mean that private litigants are precluded from bringing any and all lawsuits. 162 while preemption will inherently decrease litigation, drug companies are now required to publish clinical trials and adverse event summaries, providing greater clarity and information to the fda through other channels than at ffdca’s enactment. 163 additionally, the fda can rely on other “helpers” that watch and regulate the drug industry, such as watchdog groups and citizen petitions. 164 aggressive preemption can lead to better actions by manufacturers (at least theoretically). drug companies may use amounting litigation costs as a reason to increase drug prices, which in turn, limits access to drugs and harms public health. 165 again, aggressive preemption can also serve a stronger role in protecting innovation. without greater fear of state tort litigation, manufacturers may more willingly develop and promote new drugs to treat chronic and rare ————————————————————————————— 157. a practical guide, supra note 57, at 97. 158. see glantz & annas, supra note 106, at 1884 (“the theory behind preemption is that some activities . . . require nationally uniform federal regulation.”); zettler, supra note 1, at 852 (illustrating how federal regulation of drugs arose as a response to “disparate state laws”). 159. mccuskey, supra note 2, at 111. 160. whelan, supra note 4. 161. valoir & ghosh, supra note 19, at 589. 162. glantz & annas, supra note 106, at 1884 (citing silkwood v. kerr-mcgee corp., 464 u.s. 238 (1984)). 163. valoir & ghosh, supra note 19, at 557. 164. id. at 592. 165. rosenbaum, supra note 46, at 496; see also wyeth v. levine, 555 u.s. 555, 582 (2009) (breyer, j., concurring) (“i also note that some have argued that state tort law can sometimes raise prices to the point where those who are sick are unable to obtain the drugs they need.”). indiana health law review [vol. 22:1 16 diseases. 166 further, preemption gives fda the first bite at making product safety and availability determinations. one could also argue that drug and medical device regulation, as a highly scientific and technical field, is not within the general police powers of health and safety, and thus, should defer to federal laws as a default. strong preemption creates standard, minimum protections, based on safety, efficacy, and science. 167 this strategy also avoids the issue of over-warning. plaintiffs will usually present a compelling argument in the courtroom, as they are able to offer a tragic story. however, this may result in manufacturers inserting an overly expansive package insert that can bury the important information. 168 over-warning can also lead to under prescription of a beneficial medical product, which can diminish public welfare, if patients are not getting the drugs they need. 169 the fda already is conducting important balancing analysis to make sure that the benefits and risks are presented and measured for each product on the market, and it is best to respect this evaluation. 170 pursuing a more aggressive preemption strategy across the board may bring drug and device preemption policies into greater alignment. 171 additionally, just because congress did not include a broad express preemption provision in all parts of the ffdca does not mean it completely ruled out implied preemption. 172 b. advantages of pursuing a deferential fda preemption strategy the fda frequently relies on the states to help with enforcement, through regulating facilities and performing manufacturer inspections. 173 by avoiding preemption, the fda can better foster these state relationships. as the supreme court even acknowledged, given the limited resources of the agency, state laws compliment the fda’s drug regulation. 174 the fda also tends to lack sufficient resources, so state tort claims can fill in these gaps and provide additional, ————————————————————————————— 166. rosenbaum, supra note 46, at 497. 167. mccuskey, supra note 2, at 111–12; costello, supra note 24, at 852. 168. valoir & ghosh, supra note 19, at 557. 169. id. 170. see id. at 557–58. it is important to note that the fda notoriously takes a long time to make decisions; a truth that should be factored into this preemption strategy analysis. so, while the balancing analysis is important, it can take an exorbitant amount of time for the agency to complete. 171. see id. at 580–82 (“[t]here is no reason to treat the two products differently. both types of medical product are highly regulated—indeed, the regulatory regimes for drugs and class iii pma devices are largely analogous. each requires a detailed approval application including copious safety and efficacy data, as well as detailed manufacturing and packaging specifications, including the proposed text and layout of the package insert, which provides instructions for use of the drug or device.”). 172. kendrick, supra note 25, at 239. 173. a practical guide, supra note 57, at 83–84. 174. wyeth v. levine, 555 u.s. 555, 577–79 (2009). 2025] fda preemption 17 needed monitoring of manufacturers. 175 a deferential preemption strategy also allows states to fill in the gaps where greater food regulation could improve public health and safety. 176 with regards to food specifically, over-preemption and a uniform food safety approach may diminish local and sustainable food systems, because national standards can create heavy burdens and high costs for smaller producers. 177 further, fda regulations inherently encompass traditional police powers of health and safety and there is not enough in the legislative history to suggest that congress intended to completely override these powers through the ffdca. 178 deferential preemption allows the floor-ceiling model of fda drug regulation to play out in a more balanced way (as intended). 179 this strategy also permits state governments to react to public health issues in a more timely and efficient manner, too. 180 states should retain the ability to address the public health systems in their own communities, even when involving fda-regulated products. 181 moreover, this approach aligns with the legislative history of the ffdca. when congress passed the ffdca originally, it decided not to include a proposal for a private cause of action for those injured by products regulated under the act, because such a remedy was already available through state common law.182 additionally, taking away state tort suits eliminates the ability of injured patients to receive compensation. 183 when the fda is given broad authority to preempt state laws of recovery in the realm of defective drugs and devices, patients lose their main option for recourse. 184 the anti-preemption strategy leaves these potential remedies open to patients. without the protection of preemption, drug manufacturers may more actively seek to change and update drug labels to reflect comprehensive warnings about a drug, given that they want to avoid litigation. 185 consumers are arguably more protected under a ————————————————————————————— 175. costello, supra note 24, at 851 (citing wyeth, 555 u.s. at 578–79). 176. beyranevand & winters, supra note 145, at 498. 177. id. at 497. 178. la. pub. serv. comm’n v. fcc, 476 u.s. 355, 369 (1986); jared c. huber, preemption exemption: fda-approved abortion drugs after dobbs, 98 notre dame l. rev. 2217, 2228 (2023). 179. abrams, supra note 66, at 153. 180 . jason p. block, the calorie-labeling saga – federal preemption and delayed implementation of public health law, 379 new eng. j. med. 103, 104 (2018) (discussing delay in calorie count requirements due to preemptive federal law); whelan, supra note 5. 181. see zettler, supra note 1, at 896–97. 182. kendrick, supra note 25, at 238 (citing h.r. 6110, 73d cong. § 25 (1933); s. 1944, 73d cong. § 24 (1933). 183. wyeth v. levine, 555 u.s. 555, 579 (2009) (“state tort suits . . . also serve a distinct compensatory function . . . ”). 184. glantz & annas, supra note 106, at 1885; lawrence o. gostin, regulating the safety of pharmaceuticals: the fda, preemption, and the public’s health, 301 j. am. med. ass’n 2036, 2037 (2009). 185. see gostin, supra note 2, at 11–12. indiana health law review [vol. 22:1 18 deferential preemption strategy. 186 moreover, without litigation against drug and device manufacturers, the fda loses a useful tool in gathering additional safety data and ensuring that these companies are actually complying with laws and regulations. 187 finally, aggressive preemption severely limits the states’ ability to influence the federal government to adopt certain policies 188 through serving as a living laboratory 189 or making policy that more accurately reflects public desire, given that state officials are elected (and those in agencies are not). this is especially important because federal agencies historically do not give much weight to state opinion. 190 thus, this weighs in favor of a deferential preemption strategy. c. looking at three current, public health issues: opioids, obesity, and abortion 1. opioids and preemption the united states is currently experiencing a public health crisis due to opioid misuse, addiction, and overuse. 191 about two million americans are addicted to or misuse prescription opioids, with many of these users moving on to “stronger illicit drugs” after developing substance use disorder. 192 the united states prescribes opioids at higher rates than other countries and, consequently, experiences high fatalities attributed to prescription opioid use. 193 moreover, nearly half of all overdoses in 2015 are attributed to fda-approved drugs. 194 beyond death, opioids also may cause the development of a substance use disorder, impaired cognitive function, and other debilitating symptoms. 195 given the fda’s involvement in drug regulation, the agency can play a role in ————————————————————————————— 186. rosenbaum, supra note 46, at 496–97. however, it is debatable whether consumer protection and ability to seek compensation for injuries is an element of “public health.” 187. valoir & ghosh, supra note 19, at 557, 582; see also wyeth, 555 u.s. at 579 (“state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”); gostin, supra note 2, at 12 (“in 2009, the fda issued a ‘black box warning’ about the very drug at issue in pliva—metoclopramide, also known as reglan. litigation revealed that manufacturers knew the risks but did not promptly inform the fda.”). 188. beyranevand & winters, supra note 145, at 496–98; zettler, supra note 1, at 850-51. 189. mccuskey, supra note 2, at 112. 190. zettler, supra note 1, at 896. 191. patricia j. zettler et al., implementing a public health perspective in fda drug regulation, 73 food & drug l.j. 221, 221 (2018); see also abrams, supra note 66, at 149. 192. zettler et al., supra note 191, at 229. 193. id. at 222 (stating that in 2016, opioid overdoses caused 42,000 fatalities, with forty percent of those deaths attributed to prescription opioids). 194. zettler, supra note 1, at 846 (“the centers for disease control and prevention (cdc) reported that in 2015, drug overdoses resulted in over 52,000 deaths, and overdoses have eclipsed motor vehicle crashes as the leading cause of injury-related death in the united states.”). 195. zettler et al., supra note 191, at 225. 2025] fda preemption 19 decreasing the potential harms of opioids. 196 when states try to take matters into their own hands, fda preemption often proves fatal. the prime example of this is zogenix, inc. v. patrick. 197 fda approved zohydro, “a new high-dose opioid that lacked abuse-deterrent properties” in october 2013. 198 the drug entered the market in march 2014. 199 shortly after, the governor of massachusetts prohibited the sale and prescription of zohydro within the state until the manufacturer reformulated the drug to include abuse-deterrent properties, as an attempt to address the opioid epidemic.200 as a result, the manufacturer of zohydro filed suit in federal court, asking for a preliminary injunction on the ban. 201 massachusetts argued that the ban fell within the practice of medicine regulation because it governed the manner of prescribing and dispensing of zohydro. 202 but, in april 2014, a federal district court judge enjoined the prohibition on zohydro, finding the ffdca preempted massachusetts’s ban. 203 the judge determined that if the ban stood, “it would undermine the fda’s ability to make drugs available to promote and protect the public health.” 204 following the injunction, the massachusetts board of registration in medicine enacted a regulation that limited who may handle zohydro, put ample restrictions on pharmaceutical dispersion of the drug, and required a letter of medical necessity pre-prescription. 205 initially, the district court granted the manufacturer’s preliminary injunction, through implied obstacle preemption, 206 but the court revoked the injunction upon a showing of “adequate and constitutional guidance to [the] physicians” from massachusetts ————————————————————————————— 196. id. at 221. it is important to note that the fda’s powers are somewhat limited or effected by other agencies (i.e., drug enforcement administration (“dea”)) that also play a role in drug regulation. 197. no. 14-11689-rwz, 2014 wl 1454696 (d. mass. apr. 15, 2014). 198. zettler, supra note 1, at 846. 199. id. at 847; see also costello, supra note 24, at 852 (stating that in 2014, massachusetts had the thirteenth-highest drug overdose rate of any state). 200. zettler, supra note 1, at 847, 872. 201. costello, supra note 24, at 843. 202. zettler, supra note 1, at 872. 203. zogenix, inc. v. patrick, no. 14-11689-rwz, 2014 wl 1454696, at *2 (d. mass. apr. 15, 2014). 204. id. 205. zogenix, inc. v. patrick, no. 14-11689-rwz, 2014 wl 3339610, at *2 (d. mass. aug. 28, 2014); see also zogenix, inc. v. baker, no. 14-11689-rwz, 2015 wl 1206354, at *2 (d. mass. mar. 17, 2015) (“on april 22, 2014, the commonwealth's board of registration in medicine (‘borim’) promulgated an emergency regulation requiring an individually licensed prescriber to take certain steps before prescribing zohydro, including supplying a letter of medical necessity confirming that other pain management treatments had failed. similarly, on may 6, 2014, the commonwealth's board of registration in pharmacy (‘borip’) promulgated two zohydro-related regulations. the first, which i will call the ‘pharmacist-only’ regulation, stated that ‘[a] certified pharmacy technician, pharmacy technician, pharmacy technician trainee, or pharmacy intern may not handle [zohydro].’ the second contained a host of prerequisites a pharmacist must satisfy before dispensing zohydro.”). 206. costello, supra note 24, at 843–44; see also zogenix, 2014 wl 3339610, at *2, *4–*5. indiana health law review [vol. 22:1 20 and a change in law that other pain management is deemed “inadequate,” not failed. 207 the ending result created a much less arduous and stringent regulation of zohydro than the state originally desired. ultimately, while massachusetts tried to improve public health by eliminating sales of a drug that lacks abuse-deterrent qualities, at a time when opioid addiction is rampant, preemption operated to prevent the state remedy. the problem here is that the cost to public health is not borne by the manufacturers. 208 as generic drug sales continue to take a large share of the market, drug manufacturers will continue receive greater insulation from the state tort liability “ceiling” and less frequently bear the cost, leaving society and individuals to deal with the consequences. 209 while other solutions, such as a public nuisance suit, could provide this balance, preemption doctrine may create a more wide-reaching solution. 210 2. obesity and preemption obesity is another chronic public health issue in america. 211 more than 60% of adults in the united states are obese or overweight. 212 as part of the affordable care act (“aca”), congress enacted a law requiring restaurant chains with at least twenty locations to start putting calorie counts on menus. 213 the focus on restaurant calorie counts arose due to the increasing reliance on eating out in america 214 and on the heels of numerous state law requirements on labeling and calorie disclosure. 215 in 2018, eight years after its passage, the calorie labeling requirement finally took force. 216 calorie labeling may potentially create a more calorie-conscious society and aid in obesity prevention.217 given the fractured requirements across states, and the frustration that it caused for national chains, food-industry groups generally supported a federal requirement if it would preempt state and local requirements. 218 resultingly, the fda asked states to halt implementation—but then, due to an arduous notice and comment process, the public health measure ————————————————————————————— 207. zogenix, 2014 wl 3339610, at *1; zogenix, 2015 wl 1206354, at *2. 208. abrams, supra note 66, at 148–49, 159 (discussing the 2015 cost of opioid epidemic, from the white house council of economic advisers, as more than $500 billion). 209. id. at 157. 210. id. at 165. 211. lainie rutkow et al., preemption and the obesity epidemic: state and local menu labeling laws and the nutrition labeling and education act, 36 j. l., med., & ethics 772, 772 (2008). 212. id. 213. 21 u.s.c. § 343(q)(5); block, supra note 180, at 103. 214. rutkow et al., supra note 211, at 772. 215. id. at 775–76; block, supra note 181, at 103. 216. block, supra note 180, at 103. 217. id. at 105. 218. id. at 103. 2025] fda preemption 21 took years to reach fruition. 219 as a result, while preemption had the potential to create wide-sweeping and efficient public health benefits, it actually served to slow progress. 3. abortion and preemption perhaps most recently, rampant debate has emerged about whether state laws that restrict or ban access to abortion medication, in conflict with the fda’s approval, are preempted. 220 it is further unclear whether fda action may preempt a ban based on health and safety versus a ban based on morality. 221 access to mifepristone, “the abortion pill,” is considered crucial to ensure that reproductive health care is available across the country. 222 additionally, statelevel restrictions on abortion medication access “disproportionately impact vulnerable and historically marginalized communities, particularly people of color, low-income populations, persons with disabilities, and the lgbtq+ communities.”223 following the dobbs 224 decision, the biden administration released a statement that the fda regulation of mifepristone preempts any state regulations that are contrary to the agency’s determinations of safety and efficacy.225 the fda asserts that the rems and etasu on mifepristone show that the agency conducted extensive balancing of risks and benefits when approving and modifying the prescription of the drug, too. 226 obstacle preemption may serve as a means to invalidate state restrictions on mifepristone that “encroach on the fda’s purview over drug safety and effectiveness—including the agency’s responsibility to promote public health by making safe and effective drugs available.” 227 using mississippi as an example, the additional requirements on prescription and dispersion, such as a 24-hour waiting period and ingestion of the pill in an abortion facility, may create an obstacle to the fda’s purpose of regulation. 228 specifically, some advocates argue that the state restrictions block patient access, which mollifies ————————————————————————————— 219. id. at 103–04. 220. e.g., huber, supra note 178, at 2218–19. 221. id. at 2250–51; rachel l. sher, fda preemption: implications of dobbs decision for uniform access to fda-approved drugs in the u.s., manatt (aug. 8, 2022), https://www.manatt.com/insights/newsletters/health-highlights/fda-preemption-implications-ofdobbs-decision-for [https://perma.cc/v23l-rv6d]. 222. patricia j. zettler & ameet sarpatwari, state restrictions on mifepristone access – the case for federal preemption, 386 n. eng. j. med. 705, 706 (2022). 223. whelan, supra note 5. 224. dobbs v. jackson women’s health org., 597 u.s. 215 (2022). 225. u.s. dep’t of just., no. 22-663, att’y gen. merrick b. garland statement on sup. ct. ruling in dobbs v. jackson women’s health org. (june, 24, 2022). 226. see patricia j. zettler et al., mifepristone, preemption, and public health federalism, 9 j.l. & biosciences 1, 14 (2023) [hereinafter mifepristone]. 227. zettler & sarpatwari, supra note 222, at 706. 228. mifepristone, supra note 226, at 13–14. https://perma.cc/v23l-rv6d https://www.manatt.com/insights/newsletters/health-highlights/fda-preemption-implications-of indiana health law review [vol. 22:1 22 the ffdca’s purpose and objectives. 229 impossibility preemption could also create fda preemption over state mifepristone restrictions. the fda could argue that where states ban or so greatly restrict a drug such that a manufacturer cannot sell its product in that state, that creates an impossibility. 230 in such a scenario, a court may find that since a manufacturer cannot comply with the state and federal regulations without stopping selling in that state, the law is preempted. 231 just as the zohydro cases prove insightful to the opioid crisis and preemption, they also apply to mifepristone. 232 similarly to zogenix, inc. v. patrick, a court may find that the fda’s public health mission supports finding preemption of state restrictions. 233 also, as with opioids, the fda put a rems on mifepristone after making a calculated risk-benefits analysis. 234 this supports a potential obstacle preemption claim against state restrictions on the sale of mifepristone.235 others argue that state bans of mifepristone are not preempted by current federal regulations, because congress never intended for the fda “to have exclusive, comprehensive domain over drug regulations.” 236 it follows that even if a drug is found safe and effective by the fda, that does not mean the drug must be sold in all fifty states. 237 this is bolstered by the fact that the ffdca lacks any express preemption provision with regards to drugs. 238 however, public health may likely be better supported by uniformly ensuring drugs are available across the entire country. iv. public health focused recommendation for future fda preemption strategy while precedent and the ffdca should guide the determination of whether fda regulations preempt state laws and restrictions, the fda’s own position and the court’s reasoning have changed frequently over the last one hundred years. thus, considering the advantages of each position, as outlined above, 239 and the particularities of current public health issues in evaluating what position ————————————————————————————— 229. id. at 14; grossi & o’connor, supra note 131, at 36–37 (citing in-person provider visits as an example of a state law that may face obstacle preemption). 230. mifepristone, supra note 227, at 17–18; see, e.g., mut. pharm. co. v. bartlett, 570 u.s. 472 (2013) (finding that stopping selling is not an option to complying with both state and federal law, because it leads to impossibility preemption of state law). 231. grossi & o’connor, supra note 131, at 35; mifepristone, supra note 226, at 18. 232. see supra part iii.c.1. 233. mifepristone, supra note 226, at 19–21. 234. id. at 14. 235. huber, supra note 178, at 2249 n.226. 236. id. at 2220. 237. id. at 2234–35; see also id. at 2245 (“the [ffdca] permits the nationwide sale of an approved drug. the [ffdca] does not require the nationwide sale of an approved drug.”). 238. id. at 2220. 239. see supra part iii. 2025] fda preemption 23 the fda should advocate for when moving forward is helpful. but, it is important to also recognize that the supreme court seems to continually move towards a more aggressive preemption doctrine. 240 with that in mind, the question becomes: how can we tailor this presumption in favor of preemption to best serve public health? one suggestion is to pursue preemption when the fda has completed “a careful balancing of competing interests” using science and technical considerations when no new information or considerations are available. 241 this risk-benefit preemption approach is already adopted and used by some courts. 242 when congress requires the fda “to do a complex balancing of numerous considerations,” such as determining if an rems is needed, and if so, what to include in the rems, “a court might reasonably conclude that state requirements additional to those in an fda-required rems pose an obstacle to the fda’s responsibility to satisfy these congressional objectives.” 243 further, the rems provisions of the ffdca clearly task the fda with considering health care system burdens and patient access to drugs. 244 this analysis might require a state, in supporting its additional restrictions or requirements on a drug, for example, to show that based on new information or on the unique local and substantial needs of the jurisdiction, the fda’s value judgment is incorrect and that the risk-benefit analysis is better balanced with the state law. 245 this balancing approach to preemption is fruitful. while there are many disadvantages to aggressive fda preemption, 246 it is a measured strategy. the approach also aligns with the court’s current presumption in favor of preemption. 247 pursuing preemption when the fda completed a balancing of risks and benefits may explain and possibly lead to better outcomes, too. for example, in buckman,248 this can support the court’s finding of preemption better than the old reliance on the floor-ceiling model.249 further, this approach may lead to a more consistent and health-focused outcome in the wyeth-pliva brand namegeneric distinction. rather than basing the determination of preemption on if the ————————————————————————————— 240. see supra part ii, iii. 241. see valoir & ghosh, supra note 19, at 557. 242. zettler, supra note 1, at 868; see also jones v. rath packing co., 430 u.s. 519, 540–43 (1977) (preempting “a california law establishing a standard for weight variance in bagged flour that differed from the federal law”); see also cosmetic, toiletry & fragrance ass’n., inc. v. minnesota, 440 f. supp. 1216, 1222 (d. minn. 1977), aff’d, 575 f.2d 1256 (8th cir. 1978) (preempting a minnesota law that required additional chlorofluorocarbon warnings on cosmetics). 243. zettler, supra note 1, at 875; mifepristone, supra note 226, at 14–15; see, e.g., zogenix, inc. v. patrick, no. 14-11689-rwz, 2014 wl 1454696 (d. mass. apr. 15, 2014) (first zogenix case enjoining massachusetts’ efforts to ban zohydro). 244. 21 u.s.c. § 355-1(f)(2). 245. costello, supra note 24, at 857. 246. see supra section iii.b. 247. see supra text accompanying note 246. 248. see supra text accompanying notes 120–27. 249. see supra note 66–67 and accompanying text, discussing floor-ceiling model. indiana health law review [vol. 22:1 24 drug manufacturer made a unilateral decision, the risk-benefit analysis will prevail. if the plaintiff can prove that there is new information, not part of the risk-benefit calculus, that posits a new risk, then that creates potential for nonpreemption. additionally, this proposed preemption strategy better aligns with the court’s reasoning in medtronic, by giving preemptive force to the fda’s specific determinations.250 this is more public health conscious than the current blanket rule approach of preemption versus non-preemption for different product categories. additionally, this helps alleviate the pains of how long it takes the fda to make decisions and issue rules. 251 when the agency is taking time to reach a determination, state laws govern in the interim. this approach can also allow for local regulations to stand if there is unique information specific to that jurisdiction that did not receive weight in the analysis from the fda, which can alleviate some of the downsides of a national system. 252 for all this to occur though, the hatch-waxman act likely needs to be amended. such a legislative change would increase the validity of this strategy, as it would provide the fda with a reasoned explanation for the change, like the court noted in wyeth. 253 this preemption strategy is also clearly beneficial in the obesity and abortion contexts. if this approach had been applied in the calorie labeling scenario, 254 since the fda had yet to promulgate rules and regulations, the state laws could have stood until the agency completed a risk-benefit analysis and issued the final rule. in future conflicts, such as the california safety food safety act additives ban, 255 this is an opportunity to see if the fda’s riskbenefits calculus involved a full picture of the cancerous properties of the additives when it approved the usage many years ago. potentially, this could serve as a catalyst for the fda to reevaluate its previous decisions, too. the risk-benefit analysis for finding preemption will also provide uniform access to mifepristone. given that the fda placed a rems and etasu on the drug, 256 it is likely this risk-benefit analysis would yield in favor of preemption.257 applying this framework to opioids is more complex. just like with mifepristone, the fda can use the rems process to demonstrate a thoughtful risk-benefit analysis in allowing these painkillers to stay on the market. while this likely means a case like zogenix would still come down in favor of preemption, 258 the framework may encourage the agency to put greater restrictions on drugs that pose higher risks, in order to show the thoughtful process behind the drug approval decision. ————————————————————————————— 250. see supra notes 117–19 and accompanying text. 251. see supra note 160. 252. rutkow et al., supra note 211, at 773. 253. see supra note 98; wyeth v. levine, 555 u.s. 555, 576 (2009). 254. see supra section iii.c.2. 255. see supra text accompanying notes 5–8. 256. see supra text accompanying note 233. 257. sher, supra note 219. 258. see supra section iii.c.1. 2025] fda preemption 25 v. conclusion over time, the united states preemption doctrine continues to develop and evolve. 259 through express and implied preemption, the doctrine became more deferential to agencies. 260 for the fda specifically, the nuances of the ffdca and the brand name versus generic distinction makes preemption analysis sometimes frustrating and not always public health minded. 261 there are many pros and cons to pursuing an aggressive or deferential fda preemption strategy, and the consequences of the fda’s approach may bear directly on current public health crises. 262 consequently, it is recommended that moving forward, the fda should argue for, and the courts should adopt, an fda preemption strategy that favors preemption when the fda conducts a risk-benefits analysis with all available information in approving a product. 263 this approach likely requires amendment of current legislation or regulations, such as the hatchwaxman act, to fully realize the strategy in all facets of fda preemption in the future. 264 such legislative amendment can further bolster and allow for the proposed public health preemption strategy to succeed. ————————————————————————————— 259. see supra part i. 260. see supra section i.c. 261. see supra part ii. 262. see supra part iii. 263. see supra part iv. 264. see supra part iv. structure bookmarks indiana health law review anything you can do, i can do better: the sexist implications & health consequences of k-12 transgender girls sports bans anything you can do, i can do better: the sexist implications & health consequences of k-12 transgender girls sports bans morgan fields * i. introduction the musical annie get your gun tells the story of real-life sharpshooter annie oakley, “[a] backwoods gal” who defied gender norms by using her marksmanship skill to support her family by selling game. 1 after she was persuaded to join a wild west show, she quickly eclipsed the show’s leading man and star marksman, frank butler, thereby jeopardizing her chance at romance with him. 2 “anything you can do” is a duet between the two characters in which both attempt to assert their superiority over the other before a competition. annie is only able to ensure the future of their romance by pretending to lose to frank during a shoot-out,3 illustrating not only the historic fragility of the male ego, but also the requirement for many women to dim their lights for the love of men. annie’s story is not unique for the women of her time (the early 1900s), but today’s girls and women often still must tiptoe around the egos of boys and men to receive their love and admiration—or to simply avoid their ire. misogyny persists, and sometimes it shows its ugly head in the oddest of places—like a transgender girls sports ban. in recent years, several state legislatures have enacted legislation intended to prevent male-to-female transgender students from participating on the sports teams which affirm their gender identities. 4 legislatures frame this legislation as protective in nature, the purported intention being to protect equality in women’s and girls’ sports by limiting access to biologically female student athletes. idaho was the first state to enact such legislation with its 2020 fairness in women’s sports act. 5 the idaho law reaches collegiate athletes and purportedly tracks various biological, psychological, and judicial rationales which suggest that biologically male athletes possess inherently superior athletic ability due to their sex-based characteristics. based on these purported justifications, the law requires designation of sports teams as only male, female, ————————————————————————————— * j.d. candidate, 2024, i.u. robert h. mckinney school of law; b.a. in psychology and philosophy, frankin college, 2021. special thanks to the author’s niece and nephews whose experiences and resiliency serve as constant sources of inspiration. 1. annie get your gun, stageagent, https://stageagent.com/shows/musical/874/annie-getyour-gun [https://perma.cc/hk9p-bxps] (last visited nov. 10, 2022). 2. id. 3. the truth behind… annie get your gun, breaking character, https://www. breakingcharacter.com/home/2020/12/11/the-truth-behind-annie-get-your-gun/ [https://perma.cc/rba9-vzp9] (last visited nov. 11, 2022). 4. equality maps: bans on transgender youth participation in sports, movement advancement project, https://www.lgbtmap.org/equality-maps/sports_participation_bans [https://perma.cc/u5nz-3chl] (last visited july 29, 2023) [hereinafter equality maps]. 5. idaho code ann. § 33-6201 (west 2020). https://perma.cc/u5nz-3chl https://www.lgbtmap.org/equality-maps/sports_participation_bans https://perma.cc/rba9-vzp9 https://breakingcharacter.com/home/2020/12/11/the-truth-behind-annie-get-your-gun https://www https://perma.cc/hk9p-bxps https://stageagent.com/shows/musical/874/annie-get indiana health law review [vol. 21:409 410 or mixed.6 the law specifies that “[a]thletic teams or sports designated for females, women, or girls shall not be open to students of the male sex.”7 a temporary preliminary injunction, issued by the idaho district court in hecox v. little, is currently blocking enforcement of idaho’s law. 8 to answer the question whether the plaintiff in hecox, a transgender woman wanting to join her state college’s women’s track and cross-country teams, had a reasonable likelihood of success on the merits of her claim at trial, the district court made several important findings. first, the court found that transgender women are an historically marginalized community and as less than one percent of the population are unlikely to “displace” female athletes. 9 additionally, the court found a lack of definitive proof regarding transgender women’s physiological advantages. 10 ultimately the idaho law was found to be discriminatory by excluding that historically disadvantaged group from participation in sports and by discriminating against another historically disadvantaged group in cisgender women by subjecting them to the sex dispute process. 11 the court stated that the transgender girls at issue under the law never go through male puberty to create any potential advantage over their female classmates and that the policies of the national collegiate athletic association 12 and idaho high school athletics association, which require testosterone suppression for at least a year prior to competing on women’s teams, does not inadequately address fairness concerns. 13 a temporary injunction is currently barring implementation of a similar law in utah for similar reasons. 14 the united states district court for the southern district of west virginia, however, found similar legislation permissible under the equal protection clause and title ix in a summary judgment order. 15 in the same order, the district court dissolved a preliminary injunction preventing the law from going into effect. 16 in a subsequent memorandum opinion, the same court denied the plaintiff’s motion to stay the dissolution of the preliminary injunction pending appeal,17 meaning the law is currently in full effect in west virginia. ————————————————————————————— 6. idaho code ann. § 33-6202 (west 2020). 7. idaho code ann. § 33-6203(2) (west 2020). 8. hecox v. little, 479 f. supp. 3d 930, 989 (idaho dist. ct. 2020), aff’d mem. 2023 wl 1097255 (9th cir. 2023), at *2. 9. id. at 977-78. 10. id. 11. id. 12. the student in hecox was enrolled in a state university attempting to join her college’s women’s cross country and track teams. id. at 946. 13. id. at 980-82. 14. roe v. utah high sch. activities ass’n, no. 220903262, 2022 u.s. dist. wl 3907182 (utah dist. ct. aug. 19, 2022). 15. see b. p. j. v. w. va state bd. of ed., no. 2:21-cv-00316, 2023 u.s. dist. wl 111875 (s.d. w. va., jan. 5, 2023), appeal denied, 2023 u.s. dist. wl 1805883 (s.d. w. va., feb. 7, 2023), at *3. 16. id. at *10. 17. b. p. j. v. w. va state bd. of ed., no. 2:21-cv-00316, 2023 u.s. dist. wl 1805883, at *3 (s.d. w. va., feb. 7, 2023). 2024] anything you can do, i can do better 411 nineteen states have since followed the lead of idaho, utah, and west virginia, including indiana. 18 in january 2022, indiana house representative michelle davis introduced house bill (h.b.) 1041, which required (1) school corporations, public schools, nonpublic schools, and associations that organize, sanction, or sponsor athletic teams to designate athletic teams according to binary sex terms—either male or female—or as coeducational or mixed; and (2) proscribes biologically male students from participating on teams designated as exclusively female sports teams. 19 the bill described the assignment of male sex as “based on a student’s biological sex at birth in accordance with the student’s genetics and reproductive biology[.]”20 this definition treats sex and reproductive biology as purely binary concepts, which is a categorically false understanding of sex and reproductive biology considering the existence of intersex individuals and individuals with extraordinary hormone production that masks the expression of their sex chromosomes by preventing the development of traditionally understood secondary sex characteristics. the bill also requires schools to establish and maintain grievance procedures for students whose schools failed to designate athletic teams according to the bill’s mandates or permitted male students to participate on female sports teams. 21 the bill creates a cause of action for students who assert they were deprived of an athletic opportunity or were indirectly or directly injured as a result of the school’s failure to follow the bill’s requirements. 22 unlike the idaho law, h.b. 1041 lacks any attempt at scientific or philosophical justification for its isolated focus on female students and girls’ sports. the purported purpose of the bill according to its author “is to maintain fair competition in girls’ sports now and in the future.”23 while maintaining fairness in girls’ sports generally is a valid and perhaps even valiant goal, it is not clear the state of indiana is facing a fairness problem in girls’ sports due to the participation of transgender girls. proponents of the bill failed to produce any instance wherein the participation of transgender ————————————————————————————— 18. equality maps, supra note 4. 19. ind. code ann. § 20-33-13-4(west 2022): “(a) a school corporation, public school, nonpublic school, or association that organizes, sanctions, or sponsors an athletic team or sport described in section 1 of this chapter shall expressly designate the athletic team or sport as one (1) of the following: (1) a male, men’s, or boys’ team or sport. (2) a female, women’s or girls’ team or sport. (3) a coeducational or mixed team sport. (b) a male, based on a student’s biological sex at birth in accordance with the student’s genetics and reproductive biology, may not participate on an athletic team or sport designated under this section as being a female, women’s or girls’ athletic team or sport.” 20. id. 21. ind. code ann. § 20-33-13-5 (west 2022). 22. ind. code ann. § 20-33-13-6 (west 2022). 23. arika herron, despite indiana governor’s veto of banning transgender girls in school sports, it will be law, indianapolis star (may 24, 2022). https:// www.indystar.com/story/news/education/2022/05/24/transgender-girls-school-sports-bill-lawdespite-governor-holcombs-veto/9794587002/ [https://perma.cc/c8v2-jgqn] [hereinafter indianapolis star article 1]. https://perma.cc/c8v2-jgqn https://www.indystar.com/story/news/education/2022/05/24/transgender-girls-school-sports-bill-law indiana health law review [vol. 21:409 412 girls—biologically male athletes—in girls’ sports negatively impacted competition or unfairly burdened female athletes. 24 this dearth of evidence suggests other justifications must belie the bill. the possibility of other justifications is only increased by the indiana legislature’s recent filing of a series of bills targeting the lgbtq+ community, deemed by opponents the “slate of hate.”25 this note proposes transgender girls’ sports bans’ true justifications are rooted in gender and sex-based stereotypes and roles which suggest the lesser capabilities and fragility of girls compared to boys, working to reinforce the idea of female inferiority and the system of patriarchy. by reinforcing this idea and system, the indiana legislature perpetuates negative social and mental health consequences for hoosier students. this note’s primary concern is the indiana law and its likely social and mental health effects on all hoosier children. to best elucidate those effects and the events leading to the law’s passage, this note will also discuss other cases which illustrate the mounting transphobia in the state and in the nation more generally, as well as psychological research on the effects of imposing gender stereotypes and sex roles on children. the goal of this note is to explain how k-12 transgender girls sports bans work to reinforce misogynistic and sexist stereotypes which paint girls and women as weak and physically inferior. then, this note will discuss how those stereotypes affect the mental and social health of children regardless of their gender presentation. in writing this note, care was taken to examine the effects of transgender sports bans on all children, whereas other notes have primarily only considered the effects on transgender students and biological girls. this note ultimately proposes that through its transgender girls’ sports ban, the indiana legislature validates the perpetuation of gender stereotypes and sex roles in the classrooms of kindergarteners, middle schoolers, and high schoolers. by doing so, the indiana legislature perpetuates a hostile environment for transgender students and biologically female students and encourages aggression and misogyny in biologically male students. this hostile environment results from students absorbing these gender and sex stereotypes and converting them into misogynistic action and internalized misogyny, which ultimately negatively ————————————————————————————— 24. arika herron, minutes after lawmakers override veto of transgender sports ban, first lawsuit is filed, indianapolis star (may 24, 2022) https://www.indystar.com/story/ news/politics/2022/05/24/indianas-transgender-sports-ban-first-lawsuit-filed-over/9904915002/ [https://perma.cc/yeq6-kyzw] [hereinafter indianapolis star article 2]. 25. of particular interest for this note are hb 1608 and sb 386. hb 1608 would ban schools and third parties from instructing students in kindergarten through third grade on gender roles, stereotypes, fluidity, expression or sexual orientation. see h.b. 1608, 123rd gen. assemb, sess. § 1 (ind. 2023). sb 386 would limit teachers from “promoting certain concepts” in topics including sex, gender identity, and sexual orientation. see s.b. 386, 123rd gen. assemb., sess. § 1 (ind. 2023). for a brief review of the entire “slate of hate” and what each bill would do if passed, see lauren chapman, indiana lawmakers file record number of anti-lgbtq+ bills, tripling previous years, wfyi (feb. 16, 2023), https://www.wfyi.org/news/articles/indiana-lawmakersfile-record-number-of-anti-lgbtq-bills-tripling-previous-years [https://perma.cc/3tz9-45c4]. https://perma.cc/3tz9-45c4 https://www.wfyi.org/news/articles/indiana-lawmakers https://perma.cc/yeq6-kyzw https://www.indystar.com/story 2024] anything you can do, i can do better 413 impact the mental and social health of all hoosier students. ii. defining essential terms & exploring theoretical understandings before engaging in discussion, it is important to define the terms used in this note. because this note is primarily concerned with psychological and sociological concepts and effects, the majority of these definitions were extracted with little modification from the american psychological association’s apa dictionary of psychology. to clarify the meaning of misogyny, which is so often erroneously presumed to mean the general hatred of women, this note also discusses kate manne’s understanding of misogyny according to her book down girl: the logic of misogyny. to explore the ramifications of misogyny as a mechanism of a patriarchal system on boys and men specifically, this note also considers bell hooks’s observations regarding the stunted abilities of men to feel and express their emotions, including love, detailed in the will to change: men, masculinity, and love. first, however, it is important to define social health and antisocial behaviors. social health is defined as the ways in which people create healthy and positive interpersonal relationships. 26 antisocial behaviors are “disruptive acts characterized by covert and overt hostility and intentional aggression toward others,” including verbal abuse, physical violence, irritability and aggressiveness, indifference or rationalization of hurting others, a strong sense of personal superiority, and covertly aggressive actions like theft, vandalism, and fire-setting.27 antisocial behaviors exist along a continuum. 28 enough antisocial behaviors may be indicative of antisocial personality disorder, 29 which laypeople typically understand as sociopathy. one can exhibit antisocial behaviors without having antisocial personality disorder, but those who exhibit persistent and severe antisocial behaviors from the age of fifteen may be considered for an antisocial personality disorder diagnosis. 30 gender and sex are frequently conflated, but the terms refer to two distinct conditions. gender is the condition of being male, female or other, and is distinguished from sex by its reference to the psychological, behavioral, social, and cultural aspects of being male or female, masculine or feminine. 31 sex refers ————————————————————————————— 26. tammy george, what is social health? definitions, examples and tips on improving your social wellness, hif (2024), https://healthhub.hif.com.au/mental-health/what-is-socialhealth-definitions-examples-and-tips-on-improving-your-social-wellness [https://perma.cc/pk8r-x6mt] (last visited nov. 16, 2022). 27. anti-social behavior indicators, crafton hills coll. https://www.craftonhills.edu/ faculty-and-staff/behavior-intervention-team/anti-social-behavior-indicators.php [https://perma. cc/vry6-7726] (last visited nov. 16, 2022). 28. id. 29. id. 30. id. 31. gender, apa dictionary of psych. (2d ed. 2015). https://perma https://www.craftonhills.edu https://perma.cc/pk8r-x6mt https://healthhub.hif.com.au/mental-health/what-is-social indiana health law review [vol. 21:409 414 to the specific physical and biological traits which distinguish males from females.32 one’s gender identity, which is one’s self-identification as male or female and is influenced by both environmental (societal structures, cultural expectations, and personal interactions) and biological factors, 33 does not always perfectly align with the traditional understanding of sex as determinative of gender. humans often prescribe roles according to one’s sex and gender. one’s gender role encompasses behaviors and personality traits that culturally define masculinity and femininity.34 those whose gender identities match cultural expectations of behavior and roles considered socially appropriate for one’s sex as male or female are considered cisgender. 35 those whose gender identities differ from culturally determined gender roles for their birth sex or sex surgically assigned at birth (in the case of intersex individuals) are considered transgender. 36 transgender individuals may experience gender dysphoria, which is discontent with the physical or social aspects of one’s sex and distress resulting from a sense of incongruence regarding one’s sex and gender,37 prior to transitioning or adopting an alternate gender identity. gender roles do not exist in a vacuum, nor are they necessarily an inherent aspect of human nature. gender roles occur through gender-role socialization, or the conditioning of people to the roles and expectations of behaviors prescribed by society for males and females. 38 people develop gender schemas to understand gender roles and ascribe them to others. gender schemas are organized sets of beliefs and expectations that inform one’s understanding of maleness and femaleness. 39 through a process called gender typing, people develop and internalize expectations regarding behavior based on biological sex.40 gender roles, gender schemas, and gender typing are each interrelated to gender stereotypes, which are relatively fixed and simplified concepts of attitudes and behaviors associated with masculinity or femininity. 41 gender stereotypes are used to support the social conditioning of gender roles. 42 the mere existence of these terms suggests observable phenomena. while they may have not used these exact terms to describe their observations, feminist theorists have long recognized how we are socially conditioned to adopt gendered roles in society and how the adoption of these roles is integral to the continued functioning of the harmful system underlying our society— ————————————————————————————— 32. sex, apa dictionary of psych. (2d ed. 2015). 33. gender identity, apa dictionary of psych. (2d ed. 2015). despite this definition’s binary construction of sex, a person’s gender identity may be neither male nor female. 34. gender role, apa dictionary of psych. (2d ed. 2015). 35. cisgender, apa dictionary of psych. (2d ed. 2015). 36. transgender, apa dictionary of psych. (2d ed. 2015). 37. gender dysphoria, apa dictionary of psych. (2d ed. 2015). 38. gender-role socialization, apa dictionary of psych. (2d ed. 2015). 39. gender schema, apa dictionary of psych. (2d ed. 2015). 40. gender typing, apa dictionary of psych. (2d ed. 2015). 41. gender stereotypes, apa dictionary of psych. (2d ed. 2015). 42. id. 2024] anything you can do, i can do better 415 patriarchy. in the will to change: men, masculinity, and love, bell hooks defines patriarchy as “a political-social system that insists that males are inherently dominating, superior to everything and everyone deemed weak, especially females, and endowed with the right to dominate and rule over the weak and to maintain that dominance through various forms of psychological terrorism and violence.”43 according to hooks, “[p]atriarchy promotes insanity. it is at the root of the psychological ills troubling men in our nation.”44 this promotion of insanity and mental illness begins in boyhood, where boys are socialized through violence and disconnection to turn into emotionally stunted men yearning for connection. 45 they learn in early childhood to silence and suppress their core feelings to achieve the patriarchal masculine ideal. 46 the objectives of a patriarchal system can only be met with finely tuned instruments forged to reinforce the domination complex inherent in a patriarchal society as explained by hooks. one such instrument is misogyny. in down girl: the logic of misogyny, kate manne offers a nuanced understanding of misogyny that adequately accounts for the reality of its effects and how it is wielded as a weapon. according to manne, misogyny is “the system that operates within a patriarchal social order to police and enforce women’s subordination and to uphold male dominance.”47 manne differentiates this more accurate conceptualization from the naïve conception of misogyny, which is the traditional understanding that misogyny refers to a property of individuals, typically but not necessarily men, who are prone to hatred, hostility, or other negative emotions toward women “simply because they are women.”48 the naïve conception envisions misogyny as a personal, psychological problem “rather than a systematic facet of social power relations and a predictable manifestation of the ideology that governs them: patriarchy.”49 the naïve conception is inadequate because (1) it makes misogyny difficult to diagnose unless one is the misogynist’s psychologist, (2) by making it difficult to diagnose, it silences women who try to describe their experiences of misogyny which fall short of overt manifestations of hatred, and (3) it creates an affirmative defense to misogyny in all cases of misogyny because a misogynist’s hatred rarely extends to all women—they frequently valorize the women which conform to their ideas of womanhood. 50 misogyny as an instrument of maintaining a patriarchal system is important to consider with respect to h.b. 1041 because misogyny is learned. children are assigned patriarchal gender roles and are guided by adults in how to best fulfill ————————————————————————————— 43. bell hooks, the will to change: men, masculinity, and love, 18 (2004). 44. see id. at 111. 45. id. at 60. 46. id. at 135, 153. 47. kate manne, down girl: the logic of misogyny, 33 (2018). 48. id. at 32. 49. id. at 48-49. 50. id. at 44-45. indiana health law review [vol. 21:409 416 their roles. 51 as they grow, children learn to police their own and others’ confinement within those roles, often by wielding the weapon of misogyny. these patriarchal teachings are reinforced through institutions—including schools and sports arenas.52 however, these patriarchal teachings have ramifications beyond the context of schools and sports. the long-term negative impacts of patriarchal teachings and misogyny on girls and women have been thoroughly considered by feminist theorists, but the long-term negative impacts of those teachings on boys and men have gone comparatively underdiscussed. 53 hooks uses her book to explore these impacts. hooks observes that adults tend to view gender equality in terms of granting girls the same privileges and rights as boys rather than in terms of granting boys the same rights as girls—e.g., “the right to choose not to engage in aggressive or violent play, the right to play with dolls, to play dress up, to wear costumes of either gender, the right to choose.”54 this unilateral understanding of boys and men as all-powerful neglects the reality that to be allpowerful comes at the price of emotional and mental wellness and perpetuates violence against the weak, whether those weaklings be female, male, something in between or something else entirely. to achieve and maintain dominance, boys and men must shun some of the most human parts of them—the parts that enable them to feel empathy, compassion, love, and connection. as this note will explain, sex-segregated sports, in virtue of being segregated, work to enforce gender stereotypes 55 which in turn perpetuate misogynistic attitudes. girls learn to implicitly (or in some cases explicitly) understand that they are inferior to boys. boys, on the other hand, learn to implicitly (or explicitly) view themselves as superior to girls. not only does this unreasonably inflate boys’ egos, but it also fosters a derogation toward girls and women who fail to abide by feminine gender stereotypes. they grow up to have a distaste for women who challenge their sense of superiority, not only in athletic settings but also in the world more generally.56 girls and women also ————————————————————————————— 51. hooks, supra note 43, at 18. 52. id. 53. id. 54. id. at 111. 55. see nancy leong & emily bartlett, sex segregation in sports as a public health issue, 40 cardozo l. rev. 1813, 1819 (2019) (examining how tennis rules imply women’s physical inferiority by limiting them to three sets while allowing men to play five; how female gymnasts are evaluated on different merits and face strict requirements for hair and makeup compared to male gymnasts; and how the high jump—a sport in which men tend to dominate—is considered an olympic sport whereas limbo—where women tend to dominate—is rejected as a sport despite its requirements for incredible flexibility, strength, and coordination.) 56. see manne, supra note 47 at 101-02, 271 (2018) (“[w]omen may be penalized for being too qualified, too competent. people may be ‘taken aback,’ and unwittingly engage in post hoc rationalization to make sense of their inchoate feelings of suspicion or consternation. [a] woman who has done nothing wrong in moral and social reality [. . .] may be subject to moral suspicion and consternation for violating edicts of the patriarchal rulebook. and her behavior may then be cast as dangerous, suspicious, risky, or deceptive, in line with moral verdicts already rendered.”) 2024] anything you can do, i can do better 417 hesitate to challenge themselves due to their own internalized misogyny. in the context of athletics, they may be less willing to engage in physical activities out of fear harm will inevitably befall them due to their preconceived fragility. 57 iii. mounting transphobia: h.b. 1041’s path to law after making its way through the indiana house and senate, h.b. 1041, now codified in ind. code § 20-33-13-4, landed on governor eric holcomb’s desk for approval. in his letter vetoing the bill dated march 21, 2022, governor holcomb states the law “falls short” of “provid[ing] clarity and one consistent state policy regarding the fairness in k-12 sports in indiana[.]”58 he articulated three concerns. first, the law’s grievance procedures leave unclear for students, parents, and school administrators who would establish procedures for maintaining consistency and fairness in sports and how those procedures would be established and maintained, which governor holcomb asserted could result in disparate treatment of students depending on which school they attend and compete for. 59 this uncertainty increases the likelihood of litigation against schools. 60 additionally, the governor noted the lawsuits filed or threatened to be filed on equal protection grounds in other states with similar legislation and the indiana lawsuit already filed by a student regarding h.b. 1041. 61 he asserted the issues raised in those cases should be preemptively addressed by the bill before it becomes law. 62 finally, the bill’s implication that the goals of consistency and fairness in k-12 girls’ sports are not currently being met is unfounded.63 the indiana high school athletic association’s (ihsaa) decadeold policy for determining whether a male student may participate on a girls’ sports team has not resulted in any male students being permitted to participate on a female team. 64 despite the governor’s concerns, the indiana general assembly overrode his veto to pass transgender girls’ sports ban into law on may 24, 2022. 65 the law is currently codified at indiana code § 20-33-13, with § 20-33-13-4 ————————————————————————————— 57. see allison torres burtka, girls play sports less than boys, miss out on crucial benefits, global sport matters (oct. 11, 2019), https://globalsportmatters.com/youth/2019/ 10/11/girls-play-sports-less-than-boys-miss-out-on-crucial-benefits/#:~:text=research%20show s%20that%20girls%20are,especially%20in%20their%20teen%20years [https://perma.cc/vj3gh2v6] (as to why girls turn away from sports, “research suggests the reasons include a lack of fun, cost barriers and cultural messages that tell girls in subtle and not-so-subtle ways that sports are for boys.”) (emphasis added). 58. veto letter from eric holcomb, , h.e.a. 1041 (mar. 21, 2022), https://www.in. gov/gov/files/veto-hea-1041.pdf. [https://perma.cc/xq86-yqg2] (last visited mar. 24, 2023). 59. id. 60. id. 61. id. 62. id. 63. id. 64. id. 65. herron, supra note 23. https://perma.cc/xq86-yqg2 https://www.in https://perma.cc/vj3g https://globalsportmatters.com/youth/2019 indiana health law review [vol. 21:409 418 specifically creating the designation of athletic teams requirement and prohibition of participation of male students on girls’ sports teams. 66 immediately following the override, the american civil liberties union (aclu) of indiana filed the first lawsuit, known as a.m. v. indianapolis public schools, on behalf of a ten-year-old indianapolis public schools (ips) student, challenging § 20-33-13-4 and requesting a preliminary injunction staying its implementation. 67 prior to the filing of this case in the seventh circuit, the seventh circuit and the court for the southern district of indiana heard two other cases concerning school districts’ policies targeting transgender students. in both cases, school districts refused to permit female-to-male transgender students access to the boys’ restrooms, leading those students to assert claims under title ix and the equal protection clause of the fourteenth amendment to the united states constitution. 68 while this note is not concerned with the constitutionality of transgender sports bans, and while these two cases considered school district policies and not state laws, these cases give insight into the mounting transphobia in indiana and other nearby states and the negative mental health and social health effects policy and law driven by transphobia have on transgender students. a. whitaker v. kenosha unified school district (2017) in whitaker, the united states court of appeals for the seventh circuit affirmed the grant of a preliminary injunction 69 in favor of ash, a female-tomale transgender student, who sued kenosha unified school district, located in wisconsin, for its unwritten policy prohibiting his use of the boys’ bathroom.70 ash began openly identifying and presenting as a boy during the 2013-2014 school year, his freshman year. 71 he wore his hair short, dressed in masculine clothing, and began going by ashton and masculine pronouns. 72 in his sophomore year, ash requested that his teachers and classmates refer to him with masculine pronouns and began seeing a therapist, who diagnosed him with ————————————————————————————— 66. ind. code ann. § 20-33-13-4 ( 2022). 67. indianapolis star article 2, supra note 24. 68. see whitaker v. kenosha unified sch. dist., 858 f.3d 1034, 1055 (7th cir. 2017); see also b.e. v. vigo cnty. sch. corp., 608 f. supp. 3d 725, 727 (s.d. ind. 2022). 69. the court conducted a full inquiry to determine whether to grant a preliminary injunction, including a discussion of potential remedies, the reasonable likelihood of success on the merits, and how to balance the plaintiff’s proposed impending harms versus the school district’s asserted interests. because this note is primarily concerned with the mental and social health effects of anti-transgender policy on students, i will omit discussion of potential remedies and the reasonable likelihood of success on the merits beyond acknowledging that courts have found a likelihood of success on the merits of title ix claims. discussion of these cases will instead primarily focus on the potential harms to the transgender students involved and the purported interests of the school districts. 70. whitaker, 858 f.3d at 1045-46. 71. id. at 1040. 72. id. 2024] anything you can do, i can do better 419 gender dysphoria. 73 one common treatment for gender dysphoria is hormone replacement therapy, which can include puberty-blocking hormones and crosssex hormones. 74 in 2016, ash began hormone replacement therapy and filed a petition to legally change his name to ashton.75 his petition was granted in september 2016. 76 during the spring of his sophomore year, ash’s request to use the boys’ restroom while at school and during school-sponsored events was denied by the school administration. 77 the administration told him his options were the girls’ bathroom and the gender-neutral bathroom in the school’s main office. 78 ash chose to continue using the boys’ restroom out of fear that use of the girls’ restroom would undermine his transition and draw unnecessary and unwanted attention to his transgender status. 79 after using the boys’ restroom without incident for six months, a teacher observed ash washing his hands in the boys’ restroom and reported him to the school administration. 80 the school reiterated that ash may only use the girls’ restroom or the gender-neutral bathroom in the school’s main office, conditioning his access to the boys’ restroom on ash surgically transitioning. 81 surgical transition is an inaccessible procedure to minors. 82 by making this the requirement, the school district created a policy by which no transgender student could access the bathrooms which affirm their gender identities, thus exacerbating their gender dysphoria by preventing complete assimilation and exposing them to animus from other students confused or angered by their incongruent gender presentation. security guards began monitoring ash’s bathroom use. 83 fearing his classmates would notice his use of the office bathroom and feeling deeply uncomfortable using the girls’ bathroom, ash continued using the boys’ restroom.84 this continued use resulted in frequent class disruptions, with ash being repeatedly pulled from class to discuss his violation of the school’s unwritten policy. 85 peers and teachers often questioned him regarding his frequent absences, 86 drawing further attention to his transgender status. eventually ash was given an additional bathroom option. the ————————————————————————————— 73. id. 74. see gender dysphoria, boston children’s hospital, https://www.childrenshospital. org/conditions/gender-dysphoria [https://perma.cc/8v8s-7sxk] (last visited mar. 24, 2023). 75. whitaker 858 f.3d at 1040. 76. id. 77. id. 78. id. 79. id. 80. id. at 1041. 81. id. 82. id. at 1040. 83. id. at 1041. 84. id. 85. id. 86. id. https://perma.cc/8v8s-7sxk https://www.childrenshospital indiana health law review [vol. 21:409 420 administration gave ash sole access to two additional single-user, genderneutral bathrooms on the opposite side of campus relative to his classes. 87 his sole access to these bathrooms generated intrusive questions from his peers regarding his transition. 88 the location of these bathrooms also resulted in ash missing more class time than he did using the boys’ restroom. 89 to avoid his peers’ questions and missing class, ash began restricting his water intake to avoid using the school bathrooms altogether. 90 this exacerbated ash’s symptoms of vasovagal syncope, 91 a common nervous system condition which results in the nerves connecting the heart with blood vessels to give inappropriate signals. 92 symptoms can include nausea, dizziness or lightheadedness, fainting, and blurred vision. 93 symptoms may be triggered by intense emotions like fear, intense pain, prolonged exercise, or dehydration. 94 ash’s water intake restriction resulted in fainting and dizziness. 95 ash also began suffering from stress-induced migraines.96 psychologist dr. budge, who specializes in working with adolescents and adults with gender dysphoria, testified that the school’s policy and actions “directly caus[ed] significant psychological distress and place[d] [ash] at risk for experiencing life-long diminished well-being and life-functioning.”97 she also reported ash’s treatment by the school “significantly and negatively impacted his mental health and overall well-being.”98 ash reported reemergent suicidal thoughts and worsened depression after each meeting with school officials regarding his bathroom usage. 99 dr. budge’s assessment of the policy’s effects on ash’s gender dysphoria corresponds with the known impacts of the increased risk of discrimination for transgender or gender non-conforming individuals. 100 to be clear, the distress associated with gender dysphoria is mostly due to this increased rate of discrimination, and “has been associated with an increased risk of substance abuse, self-harming behaviors, and suicide attempts.”101 this suggests the distress associated with gender non-conformity is a result of social factors rather than any innate characteristic of the individual ————————————————————————————— 87. id. at 1041-42. 88. id. 89. id. 90. id. at 1041. 91. id. 92. vasovagal syncope, cedars sinai, https://www.cedars-sinai.org/health-library/ diseases-and-conditions/v/vasovagal-syncope.html [https://perma.cc/q2ve-kgtv] (last visited nov. 10, 2022). 93. id. 94. id. 95. whitaker v. kenosha unified sch. dist., 858 f.3d 1034, 1041 (7th cir. 2017). 96. id. 97. id. at 1045. 98. id. 99. id. 100. see gender dysphoria, supra note 74. 101. id. https://perma.cc/q2ve-kgtv https://www.cedars-sinai.org/health-library 2024] anything you can do, i can do better 421 suffering the distress. to argue against the granting of a preliminary injunction in ash’s favor, the school district appealed to the privacy rights of other students and asserted the students’ parents’ rights to direct the education and upbringing of their children would be jeopardized. 102 according to the school district, issuance of an injunction would also harm the public by suggesting to other school districts a need to change policies or alter facilities to maintain compliance with title ix and retain title ix funding.103 the seventh circuit appeals court quickly dismissed these arguments. first, the court looked to the record and noted only one parent complaint and no student complaints during the six months ash used the boys’ restroom, thus illustrating no students’ privacy rights or parental rights to direct that the education and upbringing of their children were at risk of infringement. 104 second, the court also recognized the school’s concerns ignored the reality of how ash uses the bathroom: behind a closed door in a stall. 105 regarding the school’s concern of harm to the public, the court referenced statements made by amici, school administrators from 21 states and washington, d.c., who attested these hypothetical invasions of privacy never manifested throughout their efforts to maintain inclusive bathroom policies. 106 given these facts, the court found ash demonstrated the requisite likelihood to suffer irreparable harm warranting a preliminary injunction. 107 b. b.e. v. vigo county school corporation (2022) the students’ stories in b.e. are very similar to the student’s story in whitaker. like ash, 108 the b.e. plaintiffs, referred to in the case as b.e. and s.e., used names and pronouns reflecting their masculine identities, wore masculine clothes and haircuts, were diagnosed with gender dysphoria, had started gender-affirming testosterone therapy, and successfully changed their legal names to reflect their chosen masculine names. 109 they also amended their birth certificates to reflect their chosen names and gender. 110 also like ash,111 the b.e. plaintiffs used the boys’ bathrooms at the start of the school year without incident until a school employee noticed and reported it. 112 as a result of the report, vigo county school corporation, located in indiana, told the ————————————————————————————— 102. whitaker, 858 f.3d at 1054. 103. id. 104. id. at 1052. 105. id. 106. id. at 1054-55. 107. id. at 1046. 108. id. at 1040. 109. b.e. v. vigo cnty. sch. corp., 608 f. supp. 3d 725, 727 (s.d. ind. 2022). 110. id. 111. whitaker, 858 f.3d at 1040. 112. b.e., 608 f. supp. 3d at 728. indiana health law review [vol. 21:409 422 plaintiffs they were only permitted to use the girls’ bathrooms or the unisex bathrooms in the health office and would be disciplined for using the boys’ restrooms. 113 similar to ash, 114 the plaintiffs were informed they would be given access to the boys’ restroom only if they surgically transitioned. 115 because using the girls’ bathroom felt wrong to the plaintiffs and the health restroom was farther away from their classes, plaintiffs eventually strove to avoid using the school bathrooms at all. 116 this avoidance exacerbated plaintiffs’ gastrointestinal problems—s.e. once required a change of clothes because of an accident, and b.e. was once picked up early from school because his stomach hurt from “holding it.”117 in ruling on the irreparable harm to plaintiffs, the court relied primarily on expert witness and psychiatrist dr. fortenberry’s statements asserting the importance of using the bathrooms which affirm one’s gender identity to ameliorating the effects of gender dysphoria. 118 according to dr. fortenberry, [b]eing forced to use restrooms that differ from the person’s identity is a prime reminder that the transgender person is ‘different,’ and this undercuts the purpose and goal of social role transition and can exacerbate the negative consequences of gender dysphoria . . . and can have permanent negative consequences, [including] long-term influences on mental health, physical health, and overall wellbeing.119 an example of long-term consequences are increased risk of posttraumatic stress disorder, depression, anxiety, and suicidality. 120 the court also noted plaintiffs’ testimonies that using the health office bathroom made them “outcasts.”121 the plaintiffs also detailed the general distress and anxiety they experienced due to their exclusion from the boys’ restrooms.122 the school corporation asserted similar interests as those asserted by the school district in whitaker,123 namely, students’ privacy interests and public policy. 124 like the whitaker court, 125 the court for the southern district of indiana dismissed those arguments, appealing to the practical use of the restrooms by the plaintiffs (via stalls) and the civil rights of the plaintiffs and ————————————————————————————— 113. id. 114. whitaker, 858 f.3d at 1040. 115. b.e., 608 f. supp. 3d at 728. 116. id. 117. id. 118. id. at 732. 119. id. at 733 120. id. 121. id. at 734. 122. id. at 733. 123. whitaker v. kenosha unified sch. dist., 858 f.3d 1034, 1055 (7th cir. 2017). 124. b.e., 608 f. supp. 3d at 735. 125. whitaker, 858 f.3d at 1054. 2024] anything you can do, i can do better 423 other transgender students as “a purpose that is always in the public interest.”126 c. a.m. v. indianapolis public schools (2022) the plaintiff in a.m., a ten-year-old fifth grade student in the indianapolis public schools (ips) system, initiated suit against ips and the ips superintendent by her mother and next friend, e.m., through the aclu, alleging § 20-33-13-4 violates title ix, 20 u.s.c. § 1681(a) and the equal protection clause of the fourteenth amendment by discriminating against transgender students.127 unlike the student in whitaker, who began presenting as his preferred identity in high school, 128 a.m. has been living and presenting as a girl since she informed her family at four years old that she was a girl. 129 as a four-year-old, a.m. considered mutilating herself to remove her penis. 130 at the age of six a.m. was diagnosed with gender dysphoria, which untreated culminated in suicidality, depression, anxiety, anger surrounding her body, and fear regarding her ability to be a girl. 131 presumably a.m.’s mother thought embracing her daughter’s preferred identity to prevent genital mutilation and the results of untreated gender dysphoria would result in better outcomes for her child. a.m. began receiving care through riley hospital’s gender health clinic soon after her gender dysphoria diagnosis in 2018 and started a puberty blocker, leuprorelin, in august 2021. 132 due to the leuprorelin, a.m. has not experienced the physiological changes which accompany puberty in adolescent males, 133 and she would like to take feminizing hormones in the future so she can develop feminine secondary sex characteristics. 134 she changed her legal name to her preferred feminine first name in 2021. 135 prior to the passage of § 20-33-13-4 into law and the resultant litigation, a.m.’s classmates had only ever known her as a girl. 136 a.m. began playing on an ips girls’ softball team in 2021, as a fourth ————————————————————————————— 126. b.e., 608 f. supp. 3d at 736 (quoting dodds v. u.s. dep’t of educ., 845 f.3d 217, 222 (6th cir. 2016)). 127. a.m. v. indianapolis pub. sch., 617 f. supp. 3d 950, 954-55 (s.d. ind. 2022). 128. whitaker, 858 f.3d at 1040. 129. a.m., 617 f. supp. 3d at 954-55. 130. id. at 955. 131. id. at 959. 132. id. 133. puberty blockers in general work by limiting the growth of primary and secondary sex characteristics. see pubertal blockers for transgender and gender-diverse youth, mayo clinic, https://www.mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers/ art-20459075 [https://perma.cc/9vpd-vx8s] (last visited mar. 24, 2023). in a.m.’s case, the leuprorelin would ideally have the effect of preventing her voice from deepening and preventing the growth of hair and genitalia. 134. a.m., 617 f. supp. 3d at 955. 135. id. at 960. 136. id. https://perma.cc/9vpd-vx8s https://www.mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers indiana health law review [vol. 21:409 424 grader, and reported the experience helped reduce her gender dysphoria symptoms and “experience her life more fully as a girl.”137 a.m. did not appear to have a competitive edge over her teammates and was considered one of the weaker team members. 138 after the codification of § 20-33-13-4, ips informed a.m. she would not be permitted to play with her softball team during the 2022– 2023 school year because of the law. 139 since joining the boys’ baseball team would undermine her social transition to live as a girl, fail to moderate her gender dysphoria symptoms, and reveal her sex to her classmates, joining that team was determined to be both traumatic and injurious. 140 judge jane magnus-stinson ultimately granted a.m.’s motion for preliminary injunction, barring implementation of the law in the indianapolis public schools system. 141 judge magnus-stinson first considered the likelihood of success on the merits of a.m.’s title ix claim. 142 the court acknowledged the united states supreme court recently resolved the question of whether transgender status is part of sex under title vii in bostock v. clayton county, ga. 143 in bostock, the supreme court acknowledged that “transgender status [is] inextricably bound up with sex [. . .] because to discriminate on these grounds requires an employer to intentionally treat individual employees differently because of their sex. . . .” and stated “discrimination based on [. . .] transgender status necessarily entails discrimination based on sex; the first cannot happen without the second.”144 because the seventh circuit has looked to title vii when construing title ix, and the bostock court did not foreclose application of its holding to the title ix context, judge magnus-stinson looked to bostock for guidance in a.m.’s case. 145 additionally, judge magnus-stinson concluded that discrimination based on transgender status was actionable under title ix’s prohibition of sex-based discrimination as elucidated by this court in whitaker in 2017. 146 to avoid making unnecessary constitutional decisions, the district court refused to consider whether a.m. was entitled to a preliminary injunction based on her equal protection claim. 147 judge magnus-stinson also found a.m. adequately showed she would suffer irreparable harm absent issuance of an injunction by elucidating the exacerbation of gender dysphoria symptoms of suicidality, depression, anxiety, ————————————————————————————— 137. id. 138. id. 139. id. at 961. 140. id. 141. id. at 969. 142. id. at 962-66. 143. id. at 962. 144. id. at 964 (quoting bostock v. clayton county, ga, 590 u.s. 644, 140 s. ct. 1731 (2020)). 145. id. at 964-65 (quoting bostock v. clayton county, ga, 590 u.s. 644, 140 s. ct. 1731 (2020)). 146. id.; see also whitaker v. kenosha unified sch. dist., 858 f.3d 1034, 1041-42 (7th cir. 2017). 147. see a.m., 617 f. supp. 3d at 969. 2024] anything you can do, i can do better 425 and anger due to the legislation’s prevention of her playing with her school’s girls’ softball team. 148 a.m.’s mother emphasized how playing softball significantly “lessen[ed] the distressing symptoms of [a.m.’s] gender dysphoria and allowed her to experience her life more fully as a girl, result[ing] in a better self-image and confidence.”149 her mother also emphasized that prior to this situation, a.m.’s peers had only ever known a.m. as a girl. 150 by prohibiting her participation on the girls’ softball team, a.m.’s biological sex would be revealed to her classmates, who may assert she is not “really” a girl. 151 this would traumatize a.m. and undermine her social transition, further reinforcing the negative symptoms of gender dysphoria. 152 a.m.’s case was dismissed after she transferred to a charter school in january 2023. 153 a.m.’s representation, the aclu of indiana, released a statement acknowledging the dismissal was filed because of a.m.’s transfer to another school district and urging other transgender students being told they cannot participate on a public-school sports team to reach out. 154 the aclu of indiana also reasserted its argument in a.m.— we stand by our argument that when misinformation about biology and gender is used to bar transgender girls from school sports it amounts to the same form of discrimination that has long been prohibited under title ix, a law that protects all students – including trans people—on the basis of sex, as well as under the equal protection clause. 155 absent the preliminary injunction in a.m., § 20-33-13-4 is now in full effect in indiana. ————————————————————————————— 148. id. at 967. 149. id. 150. id. 151. id. 152. id. 153. michelle kaufman, lawsuit against ips regarding transgender girls playing girls sports dismissed, wrtv indianapolis (jan. 19, 2023), https://www.wrtv.com/news/localnews/indianapolis/lawsuit-against-ips-regarding-transgender-girls-playing-girls-sportsdismissed [https://perma.cc/yzk6-7ep3]; for a response from faith-based non-profit legal organization alliance defending freedom in favor of the dismissal, see rachel csutoros, female athletes score again: aclu drops legal challenge to indiana sports law, alliance defending freedom (jan. 20, 2023), https://adfmedia.org/case/am-v-indianapolis-publicschools [https://perma.cc/rb34-xz4z]. 154. kaufman, supra note 153. 155. id. https://perma.cc/rb34-xz4z https://adfmedia.org/case/am-v-indianapolis-public https://perma.cc/yzk6-7ep3 https://www.wrtv.com/news/local indiana health law review [vol. 21:409 426 iv. the history and justifications of sex-based exclusion in sports a. historical justifications—women are fragile, and men are inherently physically superior sports were originally exclusively male activities. 156 the belief that women should be excluded from the ancient olympic games persisted throughout the modern olympic movement in 1896, when founder baron pierre de coubertin justified female athletes’ exclusion with his statement that “[n]o matter how toughened a sportswoman may be, her organism is not cut out to sustain certain shocks.”157 eventually twenty-two women were permitted to participate in sailing, tennis, croquet, equestrian, and golf in the early 1900s, likely because these sports were not deemed inappropriately strenuous for women. 158 elite sports officials and medical observers believed women could not safely perform more strenuous physical activities requiring strength and stamina because of the presumption of female fragility; athletics were purportedly dangerous to reproductive health, 159 emphasizing the traditional role of women being to procreate. a harvard medical school professor, edward clarke, advised reduction of muscular and brain labor at the onset of menstruation in 1874 because physical activity during menstruation was thought to be dangerous. 160 feminine muscle development was thought to interfere with motherhood. 161 feminine muscle development also likely uncomfortably challenged beliefs regarding female fragility and their inherent subordination. inclusion of female athletes in sports accompanied women’s rights movements and historical events in which women’s capabilities in traditionally masculine activities were highlighted. 162 men generally responded to efforts to include female athletes with the assertion that female athleticism conflicted with conventional femininity, emphasizing the physical differences between the sexes to at least maintain separation of the sexes in competition.163 sports were also then viewed as suitable forums for training boys to become men. 164 men worried the inclusion of female athletes would undermine this process by feminizing men.165 the exclusion and gradual but limited inclusion of female athletes in sports emphasizes a binary understanding of sex that perfectly corresponds with a ————————————————————————————— 156. jordan buckwald, outrunning bias: unmasking the justifications for excluding nonbinary athletes in elite sport, 44 harv. j. l. & gender 1, 10-11 (2022). 157. id. at 11. 158. id. 159. id.; see also nancy leong, against women’s sports, 95 wash. u. l. rev. 1249, 1256 (2018). 160. leong, supra note 159, at 1256. 161. buckwald, supra note 156, at 11. 162. id. 163. id at 12-13. 164. id. at 13. 165. id. 2024] anything you can do, i can do better 427 binary understanding of gender identity and gendered behavior. 166 because sport as an institution formed partially to emphasize and revitalize traditionally masculine traits, the eventual inclusion of women in sports was rooted in traditional beliefs regarding sex differences and male competitive superiority. 167 these beliefs resulted in sex-centric policies like sex-verification testing.168 sexverification testing exists to validate that female athletes are ‘fully’ women and tends to be resorted to when female athletes display extraordinary talent. 169 after heinrich (dora) ratjen confessed in 1975 that he was forced to compete in the women’s high jump event disguised as a woman in the 1936 berlin olympics by german officials, sex-verification testing became routine in response to the discomfort surrounding female athleticism and fears of male athletes “masquerading” as female athletes.”170 the purported purposes of this testing is to prevent female athletes from participating against male athletes and maintain fairness in sports, 171 but it tends to prevent biologically female athletes who are especially skilled from competing. 172 because most sports tend to favor traditionally masculine physiques, female athletes whose physiques and abilities “undercut assumed notions of female frailty,” i.e., were particularly tall, maintained higher muscle-to-fat ratios, or demonstrated any sporting advantage, were suspected of being male-sexed. 173 initially, sex verification worked by requiring female athletes to present testers with their genitalia. 174 over time the testing shifted from reliance on external genitalia to chromosomal makeup. 175 testers would swab competitors’ cheeks to determine their chromosomes. 176 eventually reliance on chromosomal makeup was abandoned because it excluded female athletes with xy chromosomal patterns whose bodies were resistant to testosterone (e.g., athletes with complete androgen insensitivity syndrome, which prevents the body from properly responding to testosterone and thus results in the development of more feminine bodies) but permitted female athletes with xx chromosomal patterns who possessed conditions that enabled them to accumulate greater muscle mass and strength (e.g., congenital adrenal hyperplasia) to compete. 177 variants of genetic testing continued despite failing to unequivocally determine sex until the late 1990s and early 2000s and are now only resorted to when suspicions ————————————————————————————— 166. id. 167. id. 168. id. 169. id. at 13-14. 170. id. at 16. 171. id. at 14. 172. see matt slater, sport & gender: a history of bad science & ‘biological racism’, bbc sport (july 28, 2015) https://www.bbc.com/sport/athletics/29446276 [https://perma.cc/l59l7rnu]. 173. buckwald, supra note 156, at 15. 174. slater, supra note 172. 175. id. 176. id. 177. buckwald, supra note 156, at 16. https://perma.cc/l59l https://www.bbc.com/sport/athletics/29446276 indiana health law review [vol. 21:409 428 arise regarding an athlete’s gender identity.178 now when female athletes display extraordinary athleticism, their sex is investigated, and they are recast as men or otherwise masculinized to downplay their abilities as females to be extraordinary athletes. 179 after female athlete caster semenya broke the south african 800 meter record and setting a worldleading time in 2008, the international association of athletics federations (iaaf) asked for a gender test to prove her sex and found that the levels of testosterone her body naturally produced were normally only found in men, resulting in the iaaf scrambling to develop a plan for women with hyperandrogenism.180 after failing a gender test in 2006, indian female athlete santhi soundarajan was stripped of her 800 meter silver medal. 181 a year later she attempted suicide.182 “[i]n practical effect, sex verification tests simply served as one method of policing the boundaries of gender; effectively granting sports’ governing authorities the power to decide what standards women must conform to if they wish to compete.”183 b. modern justifications international athletic associations eventually adopted policies specifically for male-to-female transgender athletes. the international olympics committee adopted a policy in 2004 which required transgender athletes to (1) complete sex reassignment surgery, (2) complete hormone treatments for two years prior to competing, and (3) obtain legal recognition of their transitioned sex. 184 this policy was heavily criticized in part because sex reassignment surgery has no discernible athletic impact on an individual. 185 critics suggested the sex reassignment surgery requirement “impose[d] a sincerity test to weed out men who may be willing to perpetuate gender fraud by taking hormones for several years, but would presumably stop short of permanent removal of their genitals,”186 suggesting both that men would go to great lengths to obtain athletic victory, but would presumably stop short of genital removal because of how much they value their penises and testicles. the hormone requirement reflects the belief that testosterone is largely responsible for male athletes’ competitive advantage over female athletes, but there is dispute among the scientific community regarding that belief’s validity. scientists have thus far failed to demonstrate that testosterone levels in non————————————————————————————— 178. id. at 18-19. 179. id. at 19. 180. slater, supra note 172. 181. id. 182. id. 183. buckwald, supra note 156, at 19-20. 184. id. at 20. 185. id. 186. id. (quoting erin buzuvis, hormone check: critique of olympic rules on sex and gender, 31 wis. j. l. gender & soc’y 29 (2016).) 2024] anything you can do, i can do better 429 binary female athletes affect their abilities to win athletic competitions. 187 by adopting policies focused on testosterone levels, athletic associations assert that science has proven testosterone in non-binary female athletes creates an unfair advantage when no such consensus has been reached. 188 v. how gender stereotypes influence children gender presentation and internalization is largely dependent on socialization according to socialization theorists and social psychologists. as boys and girls are socialized differently depending on their biological sex and assigned gender at birth, they learn different aspects of culture through gender typing.189 various socializing agents, e.g., parents, media, school faculty, peers, etc., treat boys and girls differently. 190 these agents model behaviors and punish or reward children’s behaviors to enforce certain gender boundaries and norms. 191 parents of newborn girls describe their daughters as frailer and more delicate than parents of newborn boys describe their sons, 192 parents tend to allow greater risk-taking by boys than girls, and parents tend to use more friendly speech with boys and assertive speech with girls. 193 in school, girls are taught to speak quietly, defer to boys, avoid science and math, and value appearance over intelligence, though teachers are generally more accepting of variation from gender norms in girls than boys. 194 in media, girls are generally underrepresented, sexualized, or portrayed as helpless, while boys are typically protagonists portrayed as aggressive and powerful. 195 toys with girls as target audiences promote stereotypically feminine qualities, like attractiveness and nurturance (e.g., barbie dolls and baby dolls), while toys marketed to boys tend to promote stereotypically masculine qualities, like a propensity toward violence and competitiveness (e.g., action figures and toy race cars). 196 children interact with these agents and observe their stereotypically feminine and masculine behaviors to build personal gender schemas, defining for themselves what it means to be a boy or girl. 197 “the primacy of gender as a social category encourages children to attend to and process gender-relevant information.”198 over time and with the development of self-regulation skills, ————————————————————————————— 187. id. at 32. 188. id. 189. diane ruble & carol martin, learning to be ourselves in a gender-polarized world, growing up 74, 81 (2012), https://j.b5z.net/i/u/2084689/f/yod_ch04.pdf [https://perma.cc/wz 5e-6a7x]. 190. id. at 82. 191. id. at 83. 192. id. 193. id. at 86. 194. id. at 87. 195. id. at 89-90. 196. id. at 90. 197. id. at 82. 198. id. at 84. https://perma.cc/wz https://j.b5z.net/i/u/2084689/f/yod_ch04.pdf indiana health law review [vol. 21:409 430 children become gender-typed themselves and will encourage or perpetuate gender-typed treatment. 199 they start monitoring their own gendered conduct and making judgments about the appropriateness of their actions, reacting with approval or disapproval in an effort to match their actions with what they are socialized to believe is appropriate. 200 for example, boys may be vehemently averse to playing with baby dolls because they were socialized to believe playing with baby dolls is exclusively a girl activity. this is likely the case since parents tend to prefer toys deemed gender-appropriate for their children. 201 students who mostly play with same-gendered children tend to conform their behavior more to gender stereotypes. 202 boys who play mostly with boys tend to belittle feminine stereotyped traits. 203 in an 1996 study, children aged seven to twelve demeaned the personality of a videotaped fifth-grade girl exhibiting masculine stereotyped behavior. 204 students are also aware of gender bias; in a study of 350 fourth, sixth, and eighth graders, girls complained about discrimination in sports, reporting that girls are not picked to play basketball because they are girls.205 sociologists have conducted several studies over the years to determine the effects of gender and sex stereotypes on children in different scenarios. a study by sociologist matthew tipton on the effect of gender and sex stereotypes on children’s career aspirations across sixty-four children aged five to eleven in the united kingdom showed both boys and girls held gender stereotypes. 206 a total of 75% of children overall described boys as angry compared to girls, and the top three words used to describe boys were footballers, angry and strong, while girls were described as pretty, kind and dancers. 207 in another study, sociologist eric anderson investigated how segregated team sports fosters an oppositional masculinity that influences the reproduction of misogynistic views. 208 the article describes the costs of traditional masculinity for men and women. male athletes in team sports tend to objectify women and view them as conquerable objects.209 some studies have shown that team sport participation increases violence against other men and symbolic, domestic, and public violence against women. 210 while male athletes constitute a mere 3.7% of the men at division 1 universities, they are responsible for 19% of sexual assault reports to campus ————————————————————————————— 199. id. at 83. 200. id. 201. id. at 86. 202. id. at 88. 203. id. 204. id. 205. id. at 87-88. 206. matthew tipton, an investigation into children’s gender stereotypes and the effect they have on children’s career aspirations, 5 step j. 50, 55 (2018). 207. id. at 56-57. 208. eric anderson, “i used to think women were weak”: orthodox masculinity, gender segregation, and sport, 23 socio. f. 257, 257 (2008). 209. id. at 263. 210. id. 2024] anything you can do, i can do better 431 judicial affairs offices. 211 men involved in football, basketball, and hockey are responsible for 67% of the sexual assaults reported by other student athletes despite comprising only 30% of the student athlete population. 212 as part of his study, anderson interviewed men who joined cheerleading squads, traditionally considered a female sport, and had their perceptions of women revolutionized— after their experiences, their opinions of female athletes as weak transformed. 213 they even suggested there were many sports in which women could excel. 214 anderson ultimately concluded that the sex segregation of sports, more particularly the homosocial world of men’s team sports, socialized men to view women as sexual objects and devalued as athletes. 215 he suggests these views result in part because men are not given the opportunity to compete against women or be on teams with women for the majority of their lives. 216 taken altogether, these studies suggest the following: (1) children are influenced by society to develop binary concepts of gender, which they feel compelled to both adhere to and require similar adherence by others, often by demeaning and devaluing possession of gender-inappropriate behavior as a method of controlling their own and the behavior of other children; (2) these concepts persist beyond the classroom and permeate every aspect of children’s lives, from their choices in toys to their choices in friends and careers; and (3) these concepts persist into adolescence and adulthood and contribute to violence against women as men who were isolated from women in team sports convert these concepts into misogynistic attitudes. vi. transgender sports bans rely on inadequate biological justifications to exclude certain student athletes modern and historical justifications ignore biological variation and the myriad of congenital disorders that affect hormone uptake and production. they ignore the existence of intersex individuals. intersex refers to a variety of conditions in which a person is born with atypical reproductive or sexual anatomy, but more generally the term reflects the spectrum of natural, real biological variation.217 intersex anatomy is not always evident at birth; ————————————————————————————— 211. id. 212. id. 213. id. at 271-72. 214. id. at 271. 215. id. at 274. 216. id. 217. what is intersex?, intersex soc’y of n. am., https://isna.org/faq/what_is_intersex/ [https://perma.cc/ac45-akxl] (last visited nov. 16, 2022) [hereinafter intersex society of https://perma.cc/ac45-akxl https://isna.org/faq/what_is_intersex indiana health law review [vol. 21:409 432 individuals may be born with outwardly appearing female anatomy but possess internal male-typical anatomy and only discover their intersex condition once they are having fertility issues. 218 often times children with intersex anatomy noticeable at birth have their genitals modified or mutilated to match binary conceptions of sex, e.g., a girl born with a noticeably large clitoris and who lacks a vaginal opening219 may have her clitoris surgically reduced and a vaginal opening created. 220 as briefly discussed in earlier paragraphs, some athletes with complete androgen insensitivity syndrome possess xy chromosomal patterns but develop feminine secondary sex characteristics due their bodies’ inability to respond to testosterone, while other athletes with congenital adrenal hyperplasia possess xx chromosomal patterns but because of their congenital condition are able to accumulate greater muscle mass and strength. 221 modern justifications for excluding female athletes are similar to historical justifications. while those pressing for sex segregated sports dress up their justifications with incorrect and naïve understandings of biology, they primarily justify the exclusion of female athletes on traditional notions of gender roles and concerns regarding female frailty. while the ideal sportswoman has changed over time—female athletes are now expected to be strong, independent, and competitive compared to other female athletes—certain expectations remain, i.e., that the female athlete should be careful to maintain a feminine and sexy physique so they may continue to satisfy the male gaze. 222 female athletes who meet traditional expectations of femininity while displaying extraordinary athletic ability are valorized, while those who fail to meet these expectations have their sexes questioned and are considered “suspicious.”223 this is evidence of their primary status as sexual objects for men to enjoy and consume. the expectation is that the female athlete will remain something pretty to look at without challenging constructs of femininity or rivaling the abilities of male athletes or men in general. society’s unease regarding female athletes who transcend the traditional bounds of femininity manifests in sex-centric policies ————————————————————————————— north america]; see also what is intersex?, interact, https://interactadvocates.org/ [https://perma.cc/7xt9-qgfd] (last visited nov. 16, 2022). 218. intersex society of north america, supra note 217. 219. it is important to mention here that lacking a vaginal opening is not the equivalent of lacking a urethral opening. given the lack of comprehensive sexual education in the united states, many adults, including those with vaginas, do not realize they have not two holes down there, but three—the urethral opening, vaginal opening, and anus. see attia, how many holes does a female body have down there?, planned parenthood (oct. 28, 2019, 11:10 am), https://www.plannedparenthood.org/learn/ask-experts/help-i-know-alot-about-sex-andeverything-but-i-dont-know-anything-about-what-holes-are-for-what-i-dont-even-know-howmany-are-down-there-please-help#:~:text=the%20opening%20to%20the%20urethra%20(aka %20urethral%20opening)%20is%20the,right%20below%20your%20urethral%20opening [https://perma.cc/3bj5-bk3c]. 220. intersex society of north america, supra note 217. 221. buckwald, supra note 156 at 16. 222. id. at 44. 223. id. at 45. https://perma.cc/3bj5-bk3c https://www.plannedparenthood.org/learn/ask-experts/help-i-know-alot-about-sex-and https://perma.cc/7xt9-qgfd https://interactadvocates.org 2024] anything you can do, i can do better 433 and sex testing in athletic competitions. 224 vii. the perpetuation of gender stereotypes via transgender girls sports bans result in negative mental and social health consequences for all children what is framed as an effort to maintain fairness in women and girls’ sports is a testament to the ingrained societal belief that female athletes must be inherently physically inferior to male athletes, and therefore female athletes should be protected from their male counterparts. female physical inferiority is a transferrable stereotype in that it permeates beliefs about other activities, as evidenced by the psychological research canvased above. the implication that female individuals are naturally physically inferior raises other questions, namely: i. how physically inferior are female individuals to male individuals? ii. is that a generalizable assertion? in other words, are all female individuals, regardless of their upbringing, inclinations, biology, etc., necessarily weaker than male individuals? iii. what else about female individuals is inferior to those of male individuals? are they also cognitively inferior? iv. what other activities outside of sports should female individuals not do because of their purported frailty? what activities are they predisposed to do or ought they engage in because of their frailty, i.e., should they avoid challenging men, be eager to marry so they will have a man’s protection, or avoid challenging themselves in the public sphere? v. how should male individuals respond to female individuals’ purported frailty and their own purported strength? should they treat female individuals as delicate and easy to break? should they utilize their own purported strength to achieve certain results in their relationships with others? vi. most importantly, how will children perceive and act on these beliefs to structure their own behavior, intentionally or unintentionally? sex and gender stereotypes can have damaging effects on children in the short and long term. we know from psychological studies that children absorb sex stereotypes from their surroundings, caregivers, and peers, and tend to reify those stereotypes through their own self-policing and the policing of others. short term, children who endorse traditional sex stereotypes may restrict their interests and berate and exclude those children who fail to do the same. those ————————————————————————————— 224. id. indiana health law review [vol. 21:409 434 children who do change their behavior to conform to sex and gender stereotypes may behave in antisocial ways, negatively impacting the social health of their schools and eventually their workplaces and general society. those children who fail to conform may face inner turmoil compounded by the policing of their peers. long term, as children become adolescents and eventually adults, antisocial behaviors and inner turmoil can manifest in self-harm, the harm of others for failure to conform, and a general restriction of one’s own experiences in order to conform. this note will now consider how indiana’s k-12 transgender girls sports ban hurts the mental and social health of hoosier transgender students, cisgender boys, and cisgender girls, respectively. a. effects on transgender students the effects of indiana’s k-12 transgender girls sports ban on transgender girls are best demonstrated by the ban’s negative mental health consequences on the transgender girl in a.m., but the experiences of the transgender boys involved in b.e. and whitaker exemplify how intolerant policies result in negative mental health consequences for all transgender students. for a.m., being prevented from playing with her softball team exacerbated gender dysphoria symptoms of suicidality, depression, anxiety, and anger. 225 playing on the softball team significantly reduced a.m.’s distressing gender dysphoria symptoms and improved her self-image and confidence by solidifying for both her and her peers that she is a girl. for the boys in b.e. and whitaker, being prevented from using the bathrooms which aligned with their masculine gender presentation resulted in negative mental and physical health consequences. the boys in b.e. experienced general distress, anxiety and exacerbated gastrointestinal problems as they tried to avoid using the school bathrooms at all rather than comply with the school’s unofficial policy and jeopardize the effectiveness of their social transition. 226 in whitaker, ash’s suicidal thoughts returned and his depression worsened after each meeting with school officials regarding his bathroom usage. 227 ash was treated like a criminal, with his bathroom usage being observed by school security guards. 228 symptoms of ash’s vasovagal syncope worsened, causing him to faint, and the stress of the school’s policy caused migraines. 229 as the courts noted in these cases, the public’s interest in privacy and parents’ rights to raise and control the upbringing of their children are neither infringed nor jeopardized by these students’ use of the boys’ ————————————————————————————— 225. a.m. v. indianapolis pub. sch., 617 f. supp. 3d 950, 967 (s.d. ind. 2022). 226. see generally whitaker v. kenosha unified sch. dist., 858 f.3d 1034, 1041 (7th cir. 2017). 227. id. at 1045. 228. id. at 1041. 229. id. 2024] anything you can do, i can do better 435 bathrooms. 230 it is clear from these cases, a.m. included, that the only interests at jeopardy are those of the transgender students to exist within their schools without debilitating mental and physical health effects. b. effects on cisgender boys by reinforcing sex and gender stereotypes regarding the inherent superior physical capabilities of boys, indiana’s k-12 transgender girls sports ban perpetuates misogynistic attitudes in cisgender boys that lead to antisocial behavior toward other children. since cisgender boys associate masculinity with anger, strength, and violence, they may embrace their anger more readily and act on it with violence. they learn to demean, devalue, and objectify cisgender girls and ridicule cisgender boys who fail to abide by masculine gender stereotypes. this policing of peers turns into sex-based violence as cisgender boys become men. cisgender women who fail to be uniquely feminine, who refuse to be objectified, who challenge cisgender men cognitively and physically, are rewarded with sexual violence. while cisgender boys and men’s egos may be inflated by their misogynistic attitudes initially, cisgender boys and men are also harmed by misogyny. misogyny is a mechanism of upholding patriarchal society and therefore cisgender men’s position as the rulers of society, cisgender boys and men are discouraged from exhibiting feminine traits which are healthy to express solely because they are portrayed as unbecoming and weak. cisgender boys and men are told not to cry unless it is in anger and to be hateful as a sign of strength. these behaviors may lead to poorer intimate 231 relationship outcomes for cisgender boys and men as they restrict themselves from expressing emotion to their friends and contract their social circles to exclude cisgender girls and women, and those cisgender boys and men who fail to meet the patriarchal masculine ideal. the lesser diagnoses of depression in cisgender men 232 may be a result of this conditioned hesitancy to allow themselves to express the full spectrum of human emotion and share those feelings with others. the assertion that female athletes are frailer than, and therefore need to be protected from, their male counterparts also suggest something sinister about the nature of boys and men—that their biology makes them weapons, that they are inherently dangerous beings capable and maybe even inclined toward predation. american society reinforces this message in a myriad of ways, but ————————————————————————————— 230. id. at 1034; see also b.e. v. vigo cnty. sch. corp., 608 f. supp. 3d 725, 735 (s.d. ind. 2022). 231. intimacy does not exclusively refer to romantic or sexual relationships. intimate relationships include warm friendships developed through long association or familiarity. see intimate, merriam-webster, https://www.merriam-webster.com/dictionary/intimate [https:// perma.cc/x5a5-ph3k] (last visited nov. 16, 2022). 232. gwendolyn puryear keita, psychosocial and cultural contributions to depression in women: considerations for women midlife and beyond, 13 supp. to j. managed care pharmacy s12, s12 (2007). https://www.merriam-webster.com/dictionary/intimate indiana health law review [vol. 21:409 436 sex-segregated k-12 sports policies are particularly powerful tools because of the physical nature of many sports and the homogenous social environment the teams create. this myth being taken as truth also makes it difficult to prevent violence perpetuated by boys and men. those who do act violently outside of socially acceptable situations, especially toward those they perceive to be weaker than them, may find feeling true shame or guilt for their behaviors difficult. after all, they only became what the world told them they were born to be. meanwhile, those who fail to be aggressive even in situations where it is encouraged may be shamed as not masculine enough. cisgender boys and men are caught in a catch twenty-two. c. effects on cisgender girls by reinforcing sex and gender stereotypes regarding the inherent physical inferiority of cisgender girls and women, indiana’s k-12 transgender girls sports ban perpetuates internalized misogyny within cisgender girls and women, violence against cisgender girls and women, and limited autonomy and ambition for cisgender girls and women. because cisgender girls are taught to associate femininity with frailty, they may opt out of strenuous physical activities for fear of hurting themselves and thus deprive themselves of opportunities to build certain skills. as they develop, they are objectified and berated for their sexual anatomy and gender presentation. they learn that to be worthy, they must maintain a feminine appearance—they must be pretty to be valuable. they may pursue prettiness at the expense of the development of other skills and ambitions. as adults, they are disproportionately victimized by cisgender men, resulting in severe trauma with lasting mental health consequences. cisgender girls and women learn to shrink themselves as they live in fear of what the world has in store for them. together these experiences contribute to extremely poor mental health consequences for cisgender women, who are twice as likely to develop depression than cisgender men. 233 viii. what should be the path forward? because indiana’s k-12 transgender girls sports bans serves to emphasize and reify purported gender and sex differences that fail to accurately capture the variability of human existence, they work to restrict behaviors and interests in children and thereby may result in antisocial behavior and poorer mental health for all children. these bans are an attempt to solidify a divide between men and women that not only does not exist naturally but may only exist where children are conditioned to believe it should. teaching children to abide by binary gender norms works to place female and non-binary individuals generally below male individuals in the hierarchy of life. the socialization of children according to strict masculinity and femininity norms reinforces an exploitative system which ————————————————————————————— 233. id. 2024] anything you can do, i can do better 437 tends to result in (1) exacerbation of distressing gender dysphoria symptoms in children and adults who internally do not and cannot abide by this binary system, (2) antisocial behavior in boys and men as they are conditioned to neglect their own emotional and relational development, and (3) jeopardization of cisgender girls’ safety in the classroom and later cisgender women’s safety in public. though this note primarily considers the results of this socialization in the context of sports, this socialization clearly has long-lasting effects on society. for this reason, indiana’s k-12 transgender girls sports ban should be eliminated from its code of laws and replaced with legislation that gradually integrates k12 sports to reduce the impact of patriarchal expectations on children and the resulting antisocial behavior in childhood and adulthood. if there is anything every hoosier can agree upon, it is that the well-being of our children is of infinite importance. the research and case law are clear—sexist and misogynistic sex and gender stereotypes hurt every child, regardless of their sex and gender. to counteract the impacts of patriarchal expectations on children, states should take a proactive approach and consider legislation which would gradually integrate k-12 sports. ind. code § 20-33-13-4 need not be repealed in its entirety, but several aspects of the law should be revised. subsection 20-3313-4(b) is that which prohibits the participation of transgender girl athletes from participating on girls’ athletic teams. it should be struck from the code entirely and replaced with something resembling the following: (b) following the enactment of this legislation, [insert date], a school corporation, public school, and/or charter school, must provide only coeducational or mixed sports or athletic teams to students beginning kindergarten in the year 20xx. for every incoming group of kindergarten students thereafter, school corporations, public schools, and charter schools must continue providing only coeducational or mixed sports or athletic teams to students. effective 20xx (twelve years after the enactment of this legislation) all indiana school corporations, public schools, and charter schools must provide only coeducational or mixed sports or athletic teams to all students. by replacing ind. code. § 20-33-13-4(b) with something resembling the example above, indiana would be removing law which exacerbates negative health outcomes short and long-term for hoosier children and adults and replacing it with a necessary mechanism for a culture shift. by implementing the change gradually over the course of twelve years, the incoming child athletes will be able to grow accustomed to integrated sports and learn from the start how to hone their skills to compete against opposite sex athletes. more importantly, the students will gain deeper understanding, appreciation, and compassion for the other sex and for themselves. students spend a lot of time with their sports teams. as they continue to practice with the other sex, the unhealthy sex roles and gender expectations will indiana health law review [vol. 21:409 438 seem less imperative to fulfill. children will ideally find in their sports teams safe havens to explore and be as fully themselves as possible. this exploration and opportunity to acquaint themselves with more of the world—all the student athletes rather than just those with the same sexual anatomy or gender presentation—is critical to creating kind, socially and emotionally intelligent children with secure senses of self. it should be noted that by integrating sports teams, indiana would be removing one avenue for binary gender expression in schools. it is clear from the case law that for transgender girls in particular, participating on the sports team which affirms her gender is extremely ameliorative of gender dysphoria symptoms. while transgender students will lose one avenue for binary gender expression, they will still benefit from the integrated teams in the long-term from the relational harmony they should foster. the fact of one’s biological sex will be less necessary to question because there will be no “boys’ team” or “girls’ team.” a.m., for example, would be able to be on the baseball team with girls and boys, and given her gender expression, she would likely be identified with the girls. researchers appear not to have studied the benefits of sex-segregation in sports, but one psychological study found no real advantages associated with single-sex education compared to integrated education.234 in fact, there is evidence single-sex school environments reinforce sex stereotypes and violence. 235 sex-segregated sports, and specifically male-only teams, perpetuate the culture of male dominance “through sexual abuse and dominance by males over males as well as over females.”236 the social and emotional benefits we usually associate with team sports—the development of good sportsmanship, loyalty to a team with a common goal, and camaraderie—can be achieved just as well if not better with integrated teams. additionally, excluding associations from the legislation enables athletic associations to continue conducting, organizing, sanctioning, or sponsoring interscholastic high school athletic events for sex-segregated teams indefinitely. this is because the legislation only reaches those schools which receive state funding. this means private k-12 schools with sex-segregated teams can continue to compete against each other through the organizing of associations, leaving at least one viable alternative to integrated sports. ————————————————————————————— 234. erin pahlke et al., the effects of single-sex compared with coeducational school students’ performance and attitudes: a meta-analysis, 140 psych. bulletin 1042, 1064 (2014). 235. researchers: coed schools provide societal benefits over single-sex classes, ariz. st. univ., https://news.asu.edu/content/researchers-coed-schools-provide-societal-benefits-oversingle-sex-classes [https://perma.cc/q3m4-c58a] (last visited mar. 26, 2023). 236. julia jonieczny, there’s nothing worse than losing to a girl: an analysis of sex segregation in american youth sports, 8 ind. j. l. & soc. equality 70, 83-84 (2020). https://perma.cc/q3m4-c58a https://news.asu.edu/content/researchers-coed-schools-provide-societal-benefits-over 2024] anything you can do, i can do better 439 ix. conclusion indiana does not have a “fairness in girls’ sports” problem. indiana does have a patriarchy problem, and in that it is not alone. by amending the indiana code to integrate publicly funded k-12 sports, indiana would be pioneering a small effort to put a wrench in the cycle of the social and emotional harms of patriarchy. there is a chance for the change to be smooth and sustainable if only the indiana legislature is willing to try. structure bookmarks nything ou an oan o etterhe exist mplications ealth onsequences of ransgender irls ports ans the medical and legal plight of sickle cell patients a case study of racial disparities in health care and the potential legal remedies sonora windermere, supervised by: kenneth b. nunn, j.d.* table of contents introduction section 1: why are scd patients under-treated? 1.1 – opioids work, but how 1.2 – mislabeled addiction leads to mistreated pseudoaddiction 1. 3 – racially biased medical treatment is poor treatment 1.3.1 – racialized research created a hard habit to quit 1.3.2 – get race out of medical decisions 1.3.3 – when racial bias goes from paper to practice 1.4 – black patients and distrust go way back section 2: is there any justice for scd patients? 2.1 – approaches to physician liability 2.1.1 – medical malpractice 2.1.2 – informed consent 2.1.3 breach of fiduciary duty 2.1.4 general barriers in physician liability cases 2.2 civil rights liability 2.2.1 – title vi 2.2.2 – intentionality 2.2.3 – judicial reluctance to finding liability 2.3 – approach to substantive due process claims section 3: how can a broken system recover? 3.1 – better trained physicians make better physicians 3.2 – the resources exists, just not enough 3.3 – emergency physicians need to step up 3.4 – more efficient opioid use is possible 3.5 – expect and demand more from medicine and the law introduction sickle cell disease (scd) is an inherited blood disorder that afflicts 100,000 americans and is predominantly found in people of african and mediterranean1 * m.d., j.d. graduate 2021, university of florida colleges of medicine and law, now completing her surgical training at shands hospital in gainesville, fl. the author extends her gratitude to professor kenneth b. nunn for his mentorship and guidance during the article writing process. the author also thanks the editorial staff of the indiana health law review for their diligence in publishing this article. 1. the sickle cell gene is believed to have arisen through mutation at least twice, spreading from the mediterranean basin to surrounding lands such as northern africa, greece, and italy, 84 indiana health law review [vol. 21:83 descent.2 scd is also the most common genetic disease in the us, as 1 in 12 african americans carry the autosomal recessive mutation on one allele, and 1 in 500 african americans are born with the disease due to inheritance of two mutated alleles.3 the sickle cell mutation causes red blood cells to “sickle” and clump when partially depleted of oxygen causing the clots and subsequent ischemia that instigate the various scd syndromes.4 the numerous scd syndromes include ischemic (venous stasis) leg ulcers, avascular necrosis of the hip, shoulder, or knee, cholecystitis or gallbladder colic, priapism, headache, and gout.5 however, the lifelong and unpredictable vaso-occlusive crisis pain which most necessitates consistent management, also makes scd treatment so problematic.6 opioid analgesics are the well-established treatment for scd, and there is no ethical controversy in administering opioids to scd patients experiencing acute pain.7 early intervention with fluids and opioids is very important, because aborting voc pain can prevent extensive tissue damage.8 nevertheless, despite all the evidence supporting treatment with opioids, scd patients are often refused long-term pain management or are prescribed medications with lower efficacy than opioids.9 unfortunately, there is no quick fix to this problem because scd patients not receiving the care they need due to numerous impeding factors. section 1 of this paper discusses the issues driving health care disparities and inequities in patients with scd, including issues of past and present racial bias along with the deficient evidence driving health policy. section 2 discusses the potential legal remedies scd patients can seek when failed by the health care though mediterranean populations are now more likely to inherit thalassemia than sickle cell disease. see thomas n. williams & david j. weatherall, world distribution, population genetics, and health burden of the hemoglobinopathies, 2 cold spring harbor persp. med. 1, 11 (2012). 2. kathryn l. hassell, population estimates of sickle cell disease in the u.s., 38 am. j. preventive med. 512, 512 (2010). 3. paris b. lovett et al., sickle cell disease in the emergency department, emergency med. clinics n. am. (2014); james v. neel, the inheritance of sickle cell anemia, 110 sci. 64, 66 (1949). 4. david c rees et al., sickle-cell disease, 376 lancet 2018, 2018 (2010). 5. samir k. ballas, defining the phenotypes of sickle cell disease, 35 int’l j. for hemoglobin rsch. 511, 511-19 (2011). 6. martin h. steinberg, management of sickle cell disease, 340 new eng. j. med. 1021, 1023 (1999). 7. wally r. smith, treating pain in sickle cell disease with opioids: clinical advances, ethical pitfalls, 42 j. l. med. & ethics 139, 141 (2014). 8. samir k. ballas et al., sickle cell pain: a critical reappraisal, 120 blood 3647, 3654 (2012). 9. daniel brookoff & rosemary polomano, treating sickle cell pain like cancer pain, 116 annals internal med. 364, 367 (1992) (discussing that the unfortunate tendency to give scd patients short-term prescriptions or ineffective forms of pain medication leads to worsening conditions and increased hospital admittance despite evidence-based medicine espousing the need for adequate opioid prescribing). 2024] the medical and legal plight of sickle cell patients 85 system. finally, section 3 looks at the different ways these injustices can be prevented, by improving training for health providers, evaluating newer treatment options, and changing the standard by which physicians are judged, thus incentivizing active participation in the process toward system wide improvement. section 1: why are scd patients under-treated? 1.1 – opioids work, but how sickle cell patients need opioids for pain management because opioids treat pain for which there is otherwise no cure. in 1806, sertürner isolated morphine from the opium poppy, a discovery leading to modern opioid pharmacology.10 however, morphine is just one of 4 naturally plant-derived amines (alkaloids) that can be isolated from the opium plant, along with codeine, papaverine and thebaine. it is through the chemical manipulation of these basic alkaloids that give rise to more commonly known opioids like naloxone11 and oxycodone. the various opioids are classified based on their activity at their receptors in the body. agonists are the class of opioids producing the maximal analgesic (pain reducing) effects. partial agonists are far less effective, achieving only a partial analgesic response irrespective of dose. anti-agonists, such as naloxone produce no analgesic response when binding with their receptors, but in binding, naloxone prevents agonists from binding and triggering analgesic responses. the three main opioid receptors12 (mu/mop, delta/dop and kappa/kop) are all g-protein-coupled receptors.13 activation of the receptors in the central nervous system, specifically in the midbrain, are believed to be responsible for the pain-relieving effects of opioids. binding with these receptors has a net inhibitory effect on descending neurons, allowing for greater stimulation of 5-ht and enkephalin-containing neurons resulting in reduction of the nociceptive transmission which a person experiences as pain. however, scd pain is complex, occurring in not only nociceptive mechanisms but also through inflammatory, and neuropathic mechanisms, each of which require different approaches for pain management.14 it is the cumulative effect of these different mechanisms creating a cascade of events contributing to the organ damage associated with vasoocclusive pain episodes and thus why treating scd with opioids is more than mere palliative care aimed at alleviating the patient’s discomfort and more about 10. hasan pathan & john williams, basic opioid pharmacology: an update, 6 brit. j. pain 11, 11 (2012). 11. id. naloxone is often used to counteract opioid overdoses. 12. however, scientists have found that medical opioids interact with inner cell receptors unlike the endogenous opioids. id. at 11-16. 13. id. 14. ballas, supra note 8, at 3650; stephen p. hunt & patrick w. mantyh, the molecular dynamics of pain control, 2 nature rev. neuroscience 83, -91 (2001). 86 indiana health law review [vol. 21:83 staving off comorbidities.15 1.2 – mislabeled addiction leads to mistreated pseudoaddiction however, while it is scientifically sound to treat sickle cell pain with opioids, the competing interest in decreasing narcotic addictions can complicate decisions for treatment. scd patients suffer from a subset of chronic pain syndromes, where they experience recurrent acute exacerbations of their pain syndrome, necessitating repeated treatments with opioids.16 unfortunately, the pain accompanying these recurrent acute episodes presents differently in scd patients suffering from chronic pain than those suffering from acute pain episodes in isolation from a larger pain pathology. acute pain usually presents with sympathetic nervous system activation and obvious physical signs of suffering.17 patients suffering from chronic pain no longer exhibit these same overt signs of pain due to desensitization from exposure to painful episodes over a long course of time.18 therefore, the dissimilarity in presentation of scd patients suffering from chronic pain can lead to misdiagnoses and under-treatment of that pain.19 in one study, assessing emergency department patient perspectives, only 15% of patients experiencing high levels of pain intensity received treatment with opioids.20 this study further found that 16% of the patient population sampled would have refused opioids if offered, principally for fear of addiction, despite the indicated need.21 thus where fear of the growing opioid addiction epidemic occurs on both sides of the physician-patient relationship, understanding what addiction is, as opposed to what it is not, and appreciating the inaccuracy in recognizing its signs can help to further highlight the problems without further complicating matters by factoring in racial biases. in 1989, dr. david e. weisman introduced the term “pseudoaddiction” to describe “the iatrogenic syndrome of abnormal behavior developing as a direct consequence of inadequate pain management.”22 the term, “iatrogenic”, is used to describe pathologies inadvertently induced by physicians or medical treatment.23 dr. weisman’s’ pivotal study went further in detailing the natural 15. waltraud binder et al., involvement of substance p in the anti-inflammatory effects of the peripherally selective kappa-opioid asimadoline and the nk1 antagonist gr205171, 11 eur. j. neuroscience (1999) (discussing anti-inflammatory effects of opioids). 16. knox h. todd, chronic pain and aberrant drug-related behavior in the emergency department, 33 j. l. med. & ethics 761, 761-62 (2005). 17. id. 18. id. 19. id. 20. paula tanabe & marybeth buschmann, a prospective study of ed pain management practices and the patient’s perspective, 25 j. emergency nursing 171, 171-77 (1999). 21. id. 22. david e. weissman & david j. haddox, opioid pseudoaddiction--an iatrogenic syndrome, 36 pain 363, 363-66 (1989). 23. iatrogenic, merriam-webster’s dictionary (11th ed. 2003). 2024] the medical and legal plight of sickle cell patients 87 history of pseudoaddiction as a progression through 3 characteristic phases including: “(1) inadequate prescription of analgesics to meet the primary pain stimulus, (2) escalation of analgesic demands by the patient associated with behavioral changes to convince others of the pain’s severity, and (3) a crisis of mistrust between the patient and the health care team.”24 today, the accepted definitions of addiction and pseudoaddiction are as follows: “addiction” is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations . . . characterized by: impaired control over drug use, compulsive use, continued use despite harm, and craving. “pseudoaddiction” is a term which has been used to describe patient behaviors that may occur when pain is undertreated. patients with unrelieved pain may become focused on obtaining medications, may “clock watch,” and may otherwise seem inappropriately “drug seeking.” even such behaviors as illicit drug use and deception can occur in the patient’s efforts to obtain relief. pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated.25 therefore, recognizing the difference between addiction and pseudoaddiction can be the difference between enabling an addict or aiding in their recovery and treating or under-treating legitimate pain syndromes. however, while physicians, with varying degrees of confidence, believe they can correctly make the distinction, assessments are often influenced by subjective judgments with little predictive value regardless of whether such methods are socially accepted.26 furthermore, given the difficulty in making accurate assessments, many emergency physicians are reluctant to prescribe opioids to patients with whom they will only have a temporary relationship.27 this only further supports, as will later be discussed in section 3, the need for training in controlled substance prescribing across all specialties or an increase in the numbers of or access to the kinds of physicians that can provide long term care, observing and assessing individual patients’ behaviors and needs. such training on and awareness of proper prescribing practices are especially important given so many physicians, today, errantly rely on observations of “drug-seeking behaviors” to avoid falling for the pleas of addicts regardless of the risk of under-treating pseudoaddicts. in an attempt to organize the effort against prescribing to addicts, many health care providers and facilities have established “problem patient files” identifying patients who exhibit such “drug-seeking behaviors.” in one study 58% of emergency department medical directors acknowledged the use of such files and estimated that health care providers 24. weissman & daddox, supra note 22, at 364. 25. todd, supra note 16, at 762. 26. id. at 763. 27. id. 88 indiana health law review [vol. 21:83 consulted these files an average of 2.6 times a week.28 however, while consulting these lists may prevent over distributions, there is nothing known about the lists’ accuracy in designating patients as addicts versus pseudoaddicts or efforts to ensure lists are frequently reassessed to detect any errant designations, so to correct for under treatment. regardless, if these lists and individual patient assessments are based on observations of “drug-seeking behaviors” understanding what these behaviors are and their diagnostic value shows just how improper heavy reliance on these behaviors are in any clinical setting, emergency or otherwise. moreover, it is highly inappropriate to use the phrase “drug-seeking behaviors” in a pejorative sense as it is perfectly rational for patients in pain to seek relief. instead, a more instructive term is “aberrant drug-related behaviors,” a term which better encapsulates the broad range of more or less acceptable behaviors in the realm of pain therapy.29 below is a representative list of the various aberrant drug-related behaviors concerning addiction.30 the distinctions between many of the behaviors are highly nuanced. while well trained and experienced physicians may be able to use this list as an effective screening tool, without such insight, physicians may interpret various behaviors based on anecdotal evidence and personal biases. 28. mark a. graber et al., the use of unofficial “problem patient” files and interinstitutional information transfer in emergency medicine in iowa, 13 am. j. emergency med. 510 (1995). 29. todd, supra note 16, at 766. 30. craig l. shalmi, opioids for nonmalignant pain: issues and controversy, in principles & prac. pain med. 607 (c. a. warfield, z. h. bajwa, 2nd ed., the mcgraw-hill companies inc., 2004). 2024] the medical and legal plight of sickle cell patients 89 behaviors less suggestive of addition behaviors more suggestive of addition aggressive complaining about the need for more drugs selling prescription drugs drug hoarding during periods of reduced symptoms prescription forgery requesting specific drugs stealing or “borrowing” drugs from others openly acquiring similar drugs from other medical sources injecting oral formulations occasional unsanctioned dose escalation or other non-compliance obtaining prescription drugs from nonmedical sources unapproved use of the drug to treat another symptom concurrent abuse of alcohol or illicit drugs reporting psychic effects not intended by the clinician repeated dose escalation or similar noncompliance despite multiple warnings resistance to a change in therapy associated with “tolerable” adverse effects with expressions of anxiety related to the return of severe symptoms repeated visits to other clinicians or emergency rooms without informing prescriber drug-related deterioration in function at work, in the family, or socially repeated resistance to changes in therapy despite evidence of adverse drug effects however, these “signs” can prove very misleading because, “[g]iven the high prevalence of chronic pain and the widespread unavailability of chronic pain management resources, particularly for populations served by the emergency department, pseudoaddiction is the most likely cause for a large proportion of drug-related behaviors deemed aberrant.”31 in particular, “aggressive complaining about the need for higher doses of analgesics, and unilateral dose escalation by the patient” are suggestive of pseudoaddiction.32 scd represents the best example of the problems associated with pseudoaddiction in emergency departments. despite initial presentations mislabeled as “drug-seeking behaviors,” the signature of the scd presentation is that any such aberrant drug-related behaviors disappear after administration of appropriate pain therapy.33 this is not new information. the scd process and its mainstay treatment of opioids are both well understood. nevertheless, health professionals are reluctant 31. todd, supra note 16, at 766. 32. id. 33. id. 90 indiana health law review [vol. 21:83 to appropriately prescribe opioids to scd patients experiencing pain crises due to addiction concerns, concerns which often reflect the physician’s specialty.34 contrasting the beliefs of hematologists to emergency physicians, one survey found that where only 23% of hematologists believe twenty percent or more of scd patients to be opioid addicts, 53% of emergency physicians held this alarming assumption.35 when it came to actually treating scd patients, where 35% of hematologists reportedly followed established pain management protocols, only 17% of emergency physicians followed protocol.36 despite the fact that doctors might be held to a higher standard than nurses, given their regular involvement with scd patients, it is no less troubling that another survey found that 63% of nurses presumed prevalence of addiction in the scd population.37 while concerns for addiction are presumably well intentioned, misguided assumptions can have numerous negative effects on a mislabeled patient population of pseudoaddicts. a timid approach to treating vaso-occlusive pain crises will result in continued pain, cause increased anticipation of pain, and generate overall increased patient anxiety.38 worse yet, once the pain is adequately treated with the higher doses required due to natural tolerance development, the necessary doses often cause sedation, which then reinforces the physician’s misguided disbelief in the authenticity of their patient’s original complaint.39 on the other hand, in 1992, an inner-city university hospital in philadelphia found that instituting a structured analgesic regimen for scd patients presenting to the emergency department decreased the number of hospital admissions for sickle cell pain 44%, the number of total inpatient days by fiftyseven percent, the hospital length of stay by 23%, and the number of emergency department visits by 67%.40 by equipping patients with the correct medications, at appropriate dosages, and in sufficient quantities, patients were able to manage their chronic pain like any other lifelong medical condition and were less dependent on visits to the emergency department.41 alas, there is inadequate research to support implementation of these better practices, and nearly no mechanisms holding accountable the healthcare providers and facilities who fail to recognize and act in the face of the evidence already in existence. 34. s. h. yale et al.,approach to the vaso-occlusive crisis in adults with sickle cell disease, 61 am. fam. physician 1349-56, 1363-64 (2000). 35. b. s. shapiro et al., sickle cell-related pain: perceptions of medical practitioners 14 j. pain & symptom mgmt. 173, 168-74, (1997). 36. id. 37. a. pack-mabien et al., nurses’ attitudes and practices in sickle cell pain management, 14 applied nursing rsch. 190, 187-92 (2001). 38. todd, supra note 16, at 767. 39. id. 40. d. brookoff & r. polomano, treating sickle cell pain like cancer pain, 116 annals internal med. 367, 364-368 (1992). 41. id. 2024] the medical and legal plight of sickle cell patients 91 1. 3 – racially biased medical treatment is poor treatment notwithstanding the problems inherent to opioid prescribing across the spectrum of chronic pain pathologies, the majority of scd patients are further at a disadvantage due to the unchecked racial biases plaguing health care providers’ decisions. before getting into the complexities of racial bias in medicine it is important to note that race is not a scientifically valid concept.42 race, however, is still a social construct, a way of signaling a shared culture, and even useful when asserting a political identity. thus, in discussing race it is important to remember that black43 and white are identifiers that still hold real world significance. glossing over that significance and its unfortunate history will hinder efforts to address persistent racism and likely allow for revitalized racism to grow and become normalized when not diligently called out for the evil it is. nevertheless, along with epidemiology, medicine is the only field that still assesses races and its implications as if it had biological significance.44 nevertheless, the real harm is not in over-signifying correlation when there is no causation. the real harm in continuing to use race as a variable in a respected field is that in ignoring the impact of racial bias, it reinforces the pseudoscience of race-based perceptions of health and offers credibility to those already making raced-based decisions from a place of animosity toward what they perceive as the inferior race. 1.3.1 – racialized research created a hard habit to quit numerous studies, following a historical trend, report finding that black patients enjoy less aggressive treatment, experience lower rates of surgical treatment and receive fewer referrals to specialists than similarly presenting white patients.45 having controlled for common compounding variables such as 42. t. a. laveist, why we should continue to study race… but do a better job: an essay on race, racism and health, 6 ethnicity & disease 21, 21 (1996). 43. the terms “black” and “white” are used throughout this article because, despite there being a common origin in africa amongst all peoples, many black americans who are less directly descendent from africans do not identify as african american. furthermore, using black and white as an all-encompassing terms highlights the problem with using such identifiers as telling variables in medical decisions when both black and white people come from so many diverse backgrounds, and thus possess very diverse medical pre-conditions. 44. jay s. kaufman & richard s. cooper, in search of the hypothesis: racial differences and disease, 110 pub. health rep. 662, 663 (1995). 45. h. jack geiger, race and health care – an american dilemma?, 336 new eng. j. med. 815, 816 (1996); council on ethical and judicial affairs, black-white disparities in health care, 2344 jama, 2345 (1990); mark b. wenneker & arnold m. epstein, racial inequalities in the use of procedures for patients with ischemic heart disease in massachusetts, 261 jama 253 (1989); a. oberman & g. cutter, issues in the natural history and treatment of coronary heart disease in black populations: surgical treatment, 108 am. heart j. 688 (1984); john yergan et al., relationship between patient race and the intensity of hospital services, 25 92 indiana health law review [vol. 21:83 wealth and insurance coverage, investigators might often reason that the disparities are the result of patient preferences beyond the survey questions. of course, it is no less likely that patient preferences, differing by race, result from both patient misinformation and distrust of their physicians, two contributing factors also tied to the effects of racial bias in medical treatment. one legal scholar found that when black patients receive different care from the “preferred” patient, the white male, racial bias deprives black patients of assurances that their physician will act in the patient’s best interest contributing to systemic patient distrust of physicians.46 the other possibility, of course, is that disparate treatment is the result of racial bias or misperceptions on the part of the medical practitioner. alas, even when researchers are so bold as to acknowledge the existence of racial bias, the bias is merely characterized as an “unconscious bias,” isolated from its origins and lasting and pervasive effects in the medical context. of course, unconscious or otherwise, there is clear evidence that black patients are treated differently than white patients, disparities resulting in at least 60,000 excess deaths annually in the black patient population.47 heart disease is the leading color-blind killer in america, and yet black patients are less likely to undergo bypass surgery, coronary angioplasty, or even to receive cheap and effective preventative measures such as aspirin and beta blockers.48 most applicable to this assessment is a study that found that 65% of minority patients were denied guideline-recommended analgesic prescriptions compared with 50% of non-black patients.49 these numbers are troubling in any area of medicine, but especially concerning when bias leads to under-treating a particular race that makes up the majority of patients suffering from a particular pathology, such is the case for scd. without sufficient numbers of white scd patients needed for comparison, scd studies fail to consider or recognize how race-based disparities, affect treatment, and inadequate treatment becomes normalized without evidence highlighting the effects of racial bias. racially biased medical decisions do not happen in a vacuum and are far from being the exception to the rule. understanding the extent to which racial bias, dare one say racism, permeates through medical institutions, leads to better recognition of the positive feedback loop between those who discriminate and the organized practices that instigate and perpetuate discrimination. many of these practices are based on “taken-for-granted” background knowledge, observational findings, and short cuts created to circumvent legitimate but tedious med. care, 592 (1987). 46. vernellia r. randall, slavery, segregation and racism: trusting the health care system ain’t always easy! an african-american perspective on bioethics, 15 st. louis u. pub. l. rev. 191, 199 (1996). 47. charles deshazer, letter to the editor, 342 new eng. j. med. 518, 518 (2000). 48. saif raithore et al., race, sex, poverty, and the medical treatment of acute myocardial infarction among the elderly, 102 circulation 642,644 (2000). 49. charles s. cleeland et al., pain and treatment of pain in minority patients with cancer, 127 annals internal med. 813,813 (1997). 2024] the medical and legal plight of sickle cell patients 93 assessments.50 one of the tenants of modern medicine is the religious devotion to evidencebased medicine. however, when the evidence is based on misguided, racialized research, the resulting medicine leaves much to be desired for an already vulnerable patient population. such racialized research uses race as a variable to explain observed differences in disease incidence, health outcomes, survival rates, and even treatment responses.51 without any explicit declarations these research trends paint black patients as degenerate compared with the gold standard white patient. from a biological perspective, racialized research has suggested that black patients respond poorly to treatment in general and are more likely to die from invasive and expensive procedures.52 even modern medical literature refers to the black race as an independent risk factor for survival rates in prostate, breast, and lung cancer.53 the collection of research thus leads to inferences that black patients are biologically different from white patients and that black patients are thus genetically predisposed to disease pathologies in a way that is foreign to white patients. from a practical perspective, similarly conducted research suggests that black patients are less compliant with and less knowledgeable about their treatment to the point that black patients are less likely to consider disease as a negative influence on quality of life.54 objective research is often based on observations. however, when rationalized research reports observations devoid of any context, the findings can be misleading at best and politically weaponized at worst. in pursuit of the truth behind the observed disparities, researchers may seek to find the culprit in biology. alas, any notion that there could be some elusive biological reason likely stems from the historical efforts that sought to prove biological inferiority to justify racial suppression with science.55 regardless of any good intentions behind modern research and far more reputable research practices, dr. fullilove notes, all too often, when race is found to explain a significant portion of the 50. ronald l. jepperson, institutions, institutional effects, and institutionalism, in the new institutionalism in organizational analysis 143, 147 (walter w. powell and paul j. dimaggio eds., 1991). 51. rené bowser, racial bias in medical treatment, 105 dick. l. rev. 365, 371-72 (2001). 52. charles r. bridges et al., the effect of race on coronary bypass operative mortality, 36 j. am. coll. cardiology 1870, 1870 (2000). 53. mack. roach iii, race and the cancer research literature: the impact on health care delivery and policies, health net wellness lecture series, u. c. (oct. 24, 1994). 54. myfanwy morgan, the significance of ethnicity for health promotion: patients’ use of anti-hypertensive drugs in inner london, 24 int’l j. epidemiology s79-s83 (1995). 55. patricia a. king, justice, race and racism in research, in 7 beyond consent: seeking justice in research 88, 92 (jeffrey p. kahn et al. eds. 1998). 94 indiana health law review [vol. 21:83 variation in some health outcome, little is done to explain the meaning of the association. the result is that medical researchers act as if there were inherent—if undefined—differences between racial groups that, once signaled, require no further explanation. in an odd way, there is little difference at times between our modern science and the discredited practice of using science and medicine to justify slavery in the antebellum south: each assumes that racial differences are of unquestioned importance.56 and while many researchers at least question why race is still so frequently considered, the verdict is in. race is only a social construct with no biological basis and thus has no business serving as a proxy for a thorough investigation when making medical treatment decisions. 1.3.2 – get race out of medical decisions there is no scientific foundation for attributing observed or perceived differences between black and white patients to a particular gene or even a collection of dna markers. where geneticists recognize the 9-11% genetic variation between races responsible for skin color, there is actually greater genetic variation within each race than that between two races.57 thus, if there is no sound science behind racial distinctions, race should not be used as a determinative factor when making medical decisions. this is especially true, when in scd, the majority of patients fall within the black race, as this would support a bias against the majority of the patient population instead of treating each patient as an individual susceptible to different biological responses and prone to different behavioral profiles. far from evidence of a biological basis for race, scd is actually an example of the role the environment plays on genetic variation. the single genetic mutation responsible for scd is not more common in black people because they are black but is actually more common in the black and white populations around equatorial africa and the mediterranean because of limited mixing of those populations and the gene’s being a protective adaptation in those same areas prone to higher malaria incidence.58 nevertheless, it is inappropriate and reckless to suggest that one monogenic disease marker, more common to one race, is reason to generalize race as its own marker for disease. even in a “the ends justify the means” world, using race as a factor in research and health care decisions has not led to the improvement of care 56. mindy thompson fullilove, deconstructing race in medical research, 148 archives pediatrics & adolescent med. 1014, 1015 (oct. 1994). 57. masatoshi nei & arun k. roychoudhury, genetic relationship and evolution of human races, 14 evolutionary biology 1, 11 (1982); richard c. lewontin, apportionment of human diversity, 6 evolutionary biology 381, 397 (1972). 58. manuela caruso-nicoletti et al., growth and development in white patients with sickle cell diseases, 14 am. pediatric hematology oncology 285, 285 (1992). 2024] the medical and legal plight of sickle cell patients 95 for anyone, black patients or otherwise.59 and yet, the racialized research continues to be conducted and the findings continue to be published. and where repeated studies support the same flawed conclusions, it only makes it harder to break the cycle. unfortunately, this is largely because a black-white difference can almost always be found,60 and attributing this difference to as of yet undiscovered but still somehow probative genotypic differences between races is far more accepted than crediting systemic racism. this thinking is so pervasive that “[w]hite physicians who focus on racism as opposed to cultural peculiarities or the [true] genetic basis of disease are likely to be considered both as not ‘real scientists’ and as dangerous.”61 and thus, racism is ignored, and so are the needs of those already forced to accept racism’s hold over their lives in so many other areas of their everyday experience. 1.3.3 – when racial bias goes from paper to practice it goes without saying that health care providers have to know a vast amount of very complex information and reconcile old and new information when making every treatment decision in often rushed situations. fortunately, these decisions are guided by the best evidence available in the field. unfortunately, when the best evidence is based on treatment outcomes and survival rates, the typical racialized research studies often are that “best evidence.”62 physicians might thus use that best evidence to decide against recommending heart bypass surgery for a particular black patient, not because the surgery is any less indicated based on that patient’s history and physical, but more because statistical data shows black patients in general enjoy poorer outcomes than white patients.63 thus, when physicians place more trust in largely unscientific statistics than in the actual patient presentation, they tend to forgo much of the typical investigation and instead rely on race-based assumptions. of course, this practice is reinforced by incentives to cut costs and save time. in fact, white physicians spend less time with black patients and often do not involve their black patients in clinical decision-making processes.64 when addressing routine health maintenance concerns, physicians may not experience negative outcomes by 59. videotape: mack roach iii, race and the cancer research literature: the impact on health care delivery and policies, university of california/health net wellness lecture series, 12-13 (oct. 24, 1994). 60. jay s. kaufman & richard s. cooper, in search of the hypothesis: racial differences and disease, 110 pub. health rep. 662, 665 (1995). 61. waqar i. u. ahmad, making black people sick: “race”, ideology and health research, “race” & health in contemporary brit. 11, 26 (1993). 62. bowser, supra note 51, at 378. 63. id. at 366. 64. lisa cooper-patrick et al., race, gender and partnership in the patient-physician relationship, 282 jama 583, 586 (1999). 96 indiana health law review [vol. 21:83 implementing this technique. but by relying on race as if it contributes valuable information, physicians may overlook what is actually relevant and thus rule out certain high-risk disorders despite textbook patient presentation.65 this is no different from a physician seeing a black scd patient and relying on statistics or anecdotal background information about compliance and addiction in the black population and thus ignoring the clear indications supporting opioid prescribing. beyond how physicians picture black patients in the abstract, in a more practical sense, even the physician-patient relationship demonstrates the influence of race on physician perceptions. physicians assess patient intelligence, compliance and likelihood of substance abuse based on the patient’s race.66 even physician affiliation toward patient is associated with patient race.67 and while these too are observations of correlation versus causation, understanding how history and culture likely shaped these findings arms concerned health providers with the fuller picture of the problem so that they might more intelligently and realistically work toward solutions. “it is only when providers know that something is ‘wrong’ that they can be motivated to change the status quo to do what is ‘right’.” 1.4 – black patients and distrust go way back acknowledging that a problem exists may be the first step to solving it. however, ignoring the consequences of longstanding racial bias in medicine handicaps those working toward the solution. the long history of treating black patients as “less than” has resulted in rampant distrust of the medical field in the black patient population. correcting doctor perceptions of and behaviors toward black patients will only go so far to fix the problem if black patients still avoid health care providers. furthermore, physicians may continue to think less of the black patients with whom they struggle, not knowing the very legitimate reasons their black patients have to distrust medical professionals. the medical community recognizes that black patients, as a patient population, have a higher than average distrust toward doctors.68 the historical abuses of black people in general and black patients in specific have contributed to a feedback loop in the physician-patient relationship, only furthering the distrust.69 the tuskegee experiment, where u.s. public health service researchers studied the effects of untreated syphilis in black men, may now only 65. ritchie witzig, the medicalization of race: scientific legitimation of a flawed social construct, 125 annals internal med. 675, 677 (1996). 66. michelle van ryn & jane burke, the effect of patient race and socio-economic status on physicians’ perceptions of patients, 50 soc. sci. med. 813,820 (2000). 67. id. 68. w. michael byrd & linda a. clayton, an american health dilemma: a medical history of african americans and the problem of race: beginnings to 1900 189 (routledge, 2000). 69. mary crossley, infected judgment: legal responses to physician bias, 48 vill. l. rev. 195, 221 (2003). 2024] the medical and legal plight of sickle cell patients 97 represent a mistake of a bygone era, where the black men were subjects far more than patients. however, “in the almost twenty-five years since its disclosure, the [tuskegee] study has moved from a singular historical event to a powerful metaphor. it has come to symbolize racism in medicine, ethical misconduct in human research, paternalism by physicians and government abuse of vulnerable people.”70 when henrietta lacks, a black woman, sought treatment for her aggressive cervical cancer, her doctor collected, reproduced on a grand scale, and sold her cancer cells throughout the research community without her consent or knowledge.71 this was done to advance the field of medicine, but in a way that showed ms. lacks no more consideration than is shown to lab rats. legislation has since prohibited these practices, but the damage is done, and the consequences are certainly experienced differently between races. despite efforts to heal old wounds and dispel modern misconceptions, much of the black patient population’s distrust of medical professionals is still driven by folklore. today, in the african american community, . . . the tuskegee story is a major part of childhood folklore passed down by family members for the purpose of preparing present and future generations to deal with the harsh realities of life. by contrast, in the white community, very few have heard of the tuskegee syphilis study, and even fewer have been affected by it.72 out of distrust, black patients avoid aggressive medical treatment, fearing their physicians’ true motives behind recommendations or having concerns their physicians will not work as hard to save a black patient’s life as they might a white patient’s. of course, now too many physicians assume black patients prefer less invasive treatments and no longer see reason to offer invasive treatment despite clear indications in the patient’s presentation and diagnosis.73 therefore, white physicians, but also all health care providers in general, need to recognize that ignoring or outright denying medicine’s dark history may doom the medical field to repeat its mistakes, or only further slow the field’s ability to evolve from this history when it turns a blind eye to that history’s residual effects. disregarding patient distrust as something arising only from misinformation is insensitive and irresponsible as physicians may need to take more affirmative 70. legacy committee request, reprinted in tuskegee’s truths: rethinking the tuskegee syphilis study 559 (susan m. reverby ed., 2000). 71. ron claiborne & sidney wright, iv, how one woman’s cells changed medicine, abc world news (jan. 31, 2010), https://abcnews.go.com/wn/henrietta-lacks-woman-cells-poliocancer-flu-research-medicine/story?id=9712579#:~:text=they’re%20called%2c%20hela.,and% 20sent%20into%20outer%20space [ https://perma.cc/hk7e-fnse]. 72. peter a. clark, prejudice and the medical profession: a five-year update, 37 j. l. med. & ethics 118, 119 (2009). 73. arnold m. epstein & john z. ayanian, racial disparities in medical care, 344 new eng. j. med. 1471, 1471 (2001). 98 indiana health law review [vol. 21:83 steps to overcome these obstacles for their patient’s sake. section 2: is there any justice for scd patients? when a flawed system is slow to change on its own, a good lawsuit can sometimes give progress the kick in the pants it needs to get a move on. alas, scd patients have little hope of taking control of their situation through legal proceedings given the current laws enacted or judicially decided and many preconceived notions about the medical profession. the equal protection clause and the civil rights legislation are meant to protect the people of this nation from discrimination, especially from those in positions of power over their victims. however, these legal regimes leave minority individuals vulnerable because of the prevailing notion that patients, more so than their physicians, make the majority of their treatment decisions.74 of course, the majority of patients rely on their doctors, regardless of the patient’s race, to inform the patients of their decisions when given choice. the majority of patients also rely on their doctors’ judgment when given no choice, such as in cases of prescriptions for pain management. nevertheless, there is also a notion that health care providers have a “purity of purpose,” such that whenever they draw distinctions based on race, their actions are generally accepted as those intended to best benefit their patients of that particular race.75 this notion was previously prescribed to by those who discriminate.76 however, the practicalities of the medical field often require physicians to make decisions for their patients in their patients’ best interests, further demonstrating the need to hold biased decision makers accountable whether acting from a place of animus or well-intentioned ignorance. 2.1 – approaches to physician liability for plaintiffs’ attorneys, the conventional wisdom is “sue everybody.” thus, if a patient feels discriminated against by their physician, they may first seek remedies in tort litigation by suing their doctor to recover for the damage done or to prevent any continuation of the wrong in question. tort litigation, unlike constitutional law challenges, may only resolve an isolated issue, without forcing change on a nationwide, statewide, or even institution-wide scale. there are legal theory approaches in tort litigation which a patient can take when looking to sue a physician: medical malpractice, violation of informed consent, or breach of the physician’s fiduciary duty. 2.1.1 – medical malpractice to bring a medical malpractice action, the plaintiff claims their physician 74. fran carnerie, crisis and informed consent: analysis of a law-medicine malocclusion, 12 am. j. l. & med. 55, 55 (1986). 75. erik lillquist & charles a. sullivan, the law and genetics of racial profiling in medicine, 39 harv. civ. rts.-civ. liberties l. rev. 391, 442 (2004). 76. 110 cong. rec. 1511, 1516-2805 (1964). 2024] the medical and legal plight of sickle cell patients 99 “failed to conform to the standard of care,” causing the plaintiff injury.77 using expert medical witnesses, plaintiffs seek to prove that their physicians’ actions were inconsistent with the professional standard of care for their specific condition.78 thus where the mainstay treatment for a vaso-occlusive crises is opioids, a physician’s deviation from that standard of care would be sufficient failure to adhere to the standard of care to entitle the under-treated scd patient to recovery.79 unfortunately, unlike other assessments of the standard of care, the jury is traditionally instructed not to judge the physician based on what a reasonable person would do, but instead based on what a similarly situated physician would do, thus the need for expert witnesses to explain what physicians do.80 thus, if the defense team can offer a witness supporting the physician’s actions as consistent with the professional standard of care, then the plaintiff is entitled to no recovery. alas, there are certainly enough physicians who factor race into deciding to prescribe pain management and even more that could see a reason to withhold opioids from a particular patient beyond factoring in race. as long as the school of thought the doctor implemented when denying a scd patient opioids is still considered a valid school of thought, then it matters not if it is only a minority school of thought.81 while a number of states are moving away from a customary physician standard of care to a reasonable physician standard of care, it will still all come down to the battle of the experts where the plaintiff’s expert will claim the actions were unreasonable, while the defense witness will testify that the actions were reasonable.82 however, it is further difficult to prove medical negligence due to racial bias because the standard of care assessment looks at whether the conduct was a deviation, not whether the bias motivations caused that deviation in conduct. a plaintiff could argue that the very consideration of the patient’s race was a deviation from the professional standard of care. however, if the conduct deviated, the court will not consider the biased motivation, and if the conduct did not deviate from the standard of care,83 then the court will find the physician exercised an appropriate degree of care regardless of any racial bias that led the physician to make the challenged actions.84 therefore, scd patients believing their physicians discriminated against 77. mary crossley, infected judgment: legal responses to physician bias, 48 vill. l. rev. at 244. 78. id. 79. sheeley v. mem’l hosp., 710 a.2d 161, 166 (r.i. 1998). 80. philip g. peters, the quiet demise of deference to custom: malpractice law at the millennium, 57 wash. & lee l. rev. 163, 164-65 (2000). 81. gala v. hamilton, 715 a.2d 1108, 1110 (pa. 1998). 82. peters, supra note 80 at 170. 83. lancaster v. kaiser found. health plan of mid-atl. states, inc., 958 f. supp. 1137, 1146 (e.d. va. 1997). 84. macy v. blatchford, 8 p.3d 204, 208 (or. 2000). 100 indiana health law review [vol. 21:83 them in withholding the needed pain management will unlikely find the justice they seek choosing the medical malpractice approach. any racial bias will not matter, either because the court will assess that the conduct deviated regardless of racial motivation, or that the conduct did not deviate to justify recovery for the patient regardless of racial bias. 2.1.2 – informed consent mistreated patients could alternatively seek to have their biased physicians held liable based on the legal theory of negligent informed consent. historically, physicians needed to ask for consent before performing procedures to avoid liability for committing battery against their patients. today, the doctrine of informed consent recognizes not only battery as it pertains to patients’ rights of bodily integrity, but also the need to preserve patients’ autonomy and their rights to self-determination.85 in cases of racial discrimination, the plaintiff would not necessarily allege there was no consent but would instead argue that the physician failed to comply with the duty to fully disclose that race played a role in recommending one treatment over another. or, if the physician completely neglected to inform the patient of an alternative treatment because of the patient’s race, the patient could argue lack of informed consent.86 however, in the second scenario, it won’t matter that the physician acted out of bias, as it will only matter that the physician did not tell the patient about an alternative treatment which would be no different from the physician who neglected to tell a patient about an option without factoring in race. while the element of racial bias might make the allegedly negligent disclosure all the more unsavory, it will likely not play into a judge’s determination of fault based on the traditional analysis in informed consent causes of action.87 in cases concerning aggrieved scd patients, plaintiffs will have an even harder time proving negligent disclosure. first, patients do not consent to getting prescriptions, they simply have the option of whether or not to fill the prescription. secondly, when a physician decides against prescribing opioids based on the scd patient’s race, they will likely prescribe what the physician believes to be a less risky alternative—one with lower chance of dependency. thus, most informed consent cases are unsuccessful when this less risky alternative is prescribed. one, so far seemingly untested, approach would be for the scd patient to argue negligent informed consent during the intake process. it is quite common for hospitals to ask for consent to necessary treatment in emergency situations, such as when a scd patient arrives experiencing a vaso-occlusive crisis. the patient could allege that the intake consent form neglected to disclose that 85. barry r. furrow et al., health law at 315 (2d ed. 2000). 86. bethea v. coralli, 546 s.e.2d 542, 544-45 (ga. app. 2001). 87. barbara a. noah, the invisible patient (reviewing sally satel, how political correctness is corrupting medicine (2000)), ill. l. rev. 121, 141-47 (2002). 2024] the medical and legal plight of sickle cell patients 101 diagnostic and treatment measures might be influenced by the patient’s race. the best way to support such an argument would be to show a history of similar decisions made after providers factor race. in states, such as florida, with liberal sunshine laws, applicable to public institutions, and rather broad patient right to know laws, getting the necessary information will be possible, albeit expensive.88 nevertheless, the sticking point of most informed consent cases is proving causation. plaintiffs need to show that had the physician made full disclosures and that the patient would have reached a different decision than the one resulting in the alleged injury. this piece is especially difficult to prove in emergency situations where patients are not afforded an opportunity to make a choice, informed or otherwise ,89 or where statutes governing recovery make the sufficiency of the informed consent an objective question for a jury,90 or demand a higher culpability for liability under good samaritan acts.91 thus, only a scd patient asked to consent to less effective treatment in a non-emergency situation, by a doctor refusing to offer opioids out of concern for addiction or racial bias, might be able to prove that their consent to the less effective treatment was made after negligence disclosures, warranting recovery. 2.1.3 – breach of fiduciary duty the previous two approaches at physician liability mostly concerned the objective element of whether the conduct was negligent; there was no concern for the subjective element of whether the conduct was driven by racial bias. one way to solely hold physicians accountable for acting out of racial bias is to allege that the physician in resorting to racial bias acted counter to the patient’s best interests and thus breached a fiduciary duty to the patient. this approach focuses on the ethical principle that physicians must have an undivided loyalty to their patients or otherwise disclose any conflicts of interest, such as bias.92 88. fla. stat. § 766.204(1) (allowing health care providers to reasonably charge plaintiffs for pulling and de-identifying records). 89. exceptions to informed consent exist when the patient is unconscious, mentally incapable of giving consent, or an unaccompanied minor. see nermin ersoy et al., informed consent in emergency medicine, 29 turkish j. trauma & emergency surgery 1-8 (jan. 2010). 90. fla. stat. § 766.103 (relieving healthcare providers of liability (1) where informed consent procedures meet the accepted standard of care, (2) where a reasonable person would have had a “general understanding” of the procedure based on the information given, or (3) where a reasonable person would have gone through with the procedure had the appropriate information been given). 91. fla. stat. § 768.13 (demanding that those who have a duty to administer emergency medical services demonstrate “a reckless disregard for the consequences so as to affect the life or health of another” to be held liable, or that the care given by those volunteering emergency services be proven to have been “willful and wanton and would likely result in injury so as to affect the life or health of another”). 92. mary crossley, infected judgment: legal responses to physician bias, 48 vill. l. rev. 102 indiana health law review [vol. 21:83 in moore v. regents of the university of california, the court had to decide if the patient’s doctor needed to disclose the personally lucrative nature of procedure as a conflict of interest in recommending that procedure over another.93 the court asserted that physicians have a “fiduciary duty to disclose all information material to [a] patient’s decision . . . [including a] physician’s personal interests [that may be] unrelated to the patient’s health.”94 the court even recognized that “a physician who does have a preexisting research interest might, consciously or unconsciously, take that into consideration in recommending the procedure.”95 thus, by requiring physicians to disclose any subjective motives they might possess, moore may have created precedent to hold physicians accountable for the racial biases affecting their professional judgement when it has been proven that use of race in making treatment decisions is inappropriate and thus not in the patient’s best interest, whether done consciously or unconsciously, maliciously or not. similar to lawyers who hold control over their client’s financial interests, patients come to their doctors relying on the doctor’s specialized expertise, entrusting their care to the doctor.96 even in emergency settings, where a scd patient would ordinarily have no choice in their health care provider due to urgency or locality, “the patient could argue that, by allowing a clinically irrelevant characteristic to influence [the physician’s] choice of treatment, the physician failed to act solely in the patient’s best interest.”97 this argument would be most effective when the physician acts from a place of animus toward a particular group, but just as moore held doctors accountable for unconscious conflicts of interest, so too might a court recognize potential bias towards black patients as a conflict of interest warranting mandatory disclosure. especially in emergency situations, where a patient is in no position to monitor the physician’s decision-making process, the “physicians’ fiduciary obligations should include an obligation to ‘self-police’ their decision-making processes for any illegitimate influence.”98 unfortunately, even when courts recognize the fiduciary relationship, they have been less eager to hold physicians legally accountable.99 “fiduciary law principles have been applied to physicians only for very limited purposes .... courts and legislatures have not developed comprehensive fiduciary obligations for physicians and do not consistently hold them accountable as such.”100 195, 249 (2003). 93. moore v. regents of the university of california, 793 p.2d 479, 481-82 (cal. 1990), cert. denied, 499 u.s. 936 (1991). 94. id. at 483. 95. id. at 484. (emphasis added). 96. hoopes v. hammargren, 725 p.2d 238, 242 (nev. 1986). 97. crossley, supra note 69, at 252. 98. id. 99. pryzbowski v. u.s. healthcare, inc., 245 f.3d 266, 281-82 (3d cir. 2001). 100. marc a. rodwin, strains in the fiduciary metaphor: divided physician loyalties and obligations in a changing health care system, 21 am. j.l. & med. 241, 247-48 (1995). 2024] the medical and legal plight of sickle cell patients 103 furthermore, when cases already allege medical malpractice, courts have been loath to recognize a separate cause of action for fiduciary duty. in neades v. portes, the court refused to rule on the fiduciary claim, because both the breach of fiduciary duty and the alleged medical malpractice actions concerned the same operative facts, thus making the fiduciary duty claim duplicative.101 even where the plaintiff does not allege both medical malpractice and breach of fiduciary duty, the court may find that the fiduciary duty claim was merely creative lawyering. in states with shortened statute of limitations for medical malpractice causes of action, courts have declined “to create a new cause of action simply to permit the putative class to avoid showing injury or to circumvent the legislatively mandated statute of limitations.”102 nevertheless, when the received treatment falls within the standard of care, the patient could only claim experiencing suboptimal care, because the physician chose that care for reasons other than those in consideration of the patient’s best interests. complaining of this and the dignitary harms accompanying the patient’s violated trust, patients can distinguish these claims from straight medical malpractice claims. even in jurisdictions that only construe fiduciary duty in financial contexts, patients could argue that “cost control is an imperative in contemporary health care” and thus physicians must disclose the financial incentives “encouraging cost-conscious medical practice.”103 hospital policy may require a physician to schedule patients at fifteen-minute intervals, and private and public insurance providers may only reimburse for certain procedures or cover particular prescriptions.104 with the current push to curb opioid over-prescribing, physicians may be more persuaded against prescribing opioids to scd patients suffering from vaso-occlusive crises when they exhibit aberrant drug-related behaviors, typical of pseudoaddiction.105 however, from this perspective, physicians can sufficiently cover themselves legally by disclosing the potential conflicts and having their patients consent to treatment, given awareness of the conflicts.106 still, physicians are either unlikely to recognize their own biases or are certainly unlikely to disclose known racial bias. even when physicians recognize and disclose their biases, this should not 101. neades v. portes, 739 n.e.2d 496, 502-503 (ill. 2000). in this case, a widow sued her late husband’s physician for repeatedly failing to order what would have been a curative angiogram. 102. d.a.b. v. brown, 570 n.w.2d 168,171 (minn. ct. app. 1997). 103. crossley, supra note 69, at 254. 104. peter d. jacobson & michael t. cahill, applying fiduciary responsibilities in the managed care context, 26 am. j.l. & med. 155, 156-57 (2000). 105. mary a. bobinski, autonomy and privacy: protecting patients from their physicians, 55 u. pitt. l. rev. 291, 305 (1994) (discussing how incentives encourage physicians to withhold certain treatment). 106. mark a. hall, “rationing health care at the bedside, 69 n.y.u. l. rev. 693, 762-63 (1994) (explaining how if patients are informed of proposed incentives the conflicts created by incentives to withhold beneficial care may be alleviated). 104 indiana health law review [vol. 21:83 be sufficient to legitimize its influence over the decision-making process as the “bias, even if disclosed, remains problematic because it may serve to interfere with a patient’s receipt of optimal medical care without advancing any legitimate, countervailing interest.”107 given that race has no relevance to diagnosis and treatment decisions, its influence over physicians can have no legitimate interest, and thus cannot go forgiven or further enabled. alas, where courts are unlikely to impose liability upon physicians acting within the standard of care, the plaintiff would have to persuade courts that, despite compliance with the standard of care, the breach of fiduciary duty is independently wrong.108 therefore, even when the biased judgment resulted in no physical harm, the knowledge of that bias may affect the patient’s trust in physicians and health care in general, creating a very valid “psychic injury” warranting recovery.109 2.1.4 – general barriers in physician liability cases of course, before patients can consider bringing suit, they must first suspect bias as a significant cause of their injury. many patients defer to their physicians and rarely question their thought process. however, for black patients who are already prone to distrust their physicians, they may be more likely to notice a physician operating under a bias. still, regardless of which approach patients/plaintiffs pursue, they will have to support their claims with evidence. some patents may recognize the influence of bias in the way physicians interact with patients, patients’ family members, or even with other health care providers. while evidence of this nature will certainly help a case, plaintiffs are better off if they can point to a pattern of treatment disparities to support the tier of fact making inferences of bias in the physicians and that bias as playing a crucial role in the resulting injury. alas, presenting the kind of evidence of a pattern of biased treatment will necessitate exhibiting records of patients not a party to the matter at hand. these kinds of records are ordinarily covered by physician-patient privilege and are thus not discoverable.110 fortunately, there are a number of jurisdictions that allow discovery of this information as long as all identifiable patient information is redacted.111 one court reasoned that, “[o]nce the information cannot be connected with the patient, the risk of embarrassment that might lead a patient to withhold 107. crossley, supra note 69, at 255. 108. see generally, neades, 739 n.e.2d at 506(harrison, c.j., dissenting) (suggesting that failing to disclose financial incentives “constituted an independent wrong”). 109. hein v. freedom from religion found., inc., 551 u.s. 587, 619 (2007) (scalia, j., concurring) (suggesting the existence of psychic injuries derived from “mental displeasure” beyond wallet injuries which are more concrete and particularized). 110. scott r. white, comments, discovery of non-parties’ medical records in the face of the physician-patient privilege, 36 cal. w. l. rev. 523, 532 (2000). 111. in re rezulin prods. liab. litig., 178 f. supp. 2d 412, 416 (s.d.n.y. 2001) (holding that redacted patient information did not infringe upon physician-patient privilege). 2024] the medical and legal plight of sickle cell patients 105 information from a physician and thus interfere with proper treatment, as well as the risk of any invasion of personal privacy, is eliminated.”112 of course, this is not the case in many states, where the plaintiff will likely be barred from discovering the kind of evidence needed to support their claims of biased judgment.113 even in instances where the plaintiff can get the necessary evidence to show a pattern of biased decision-making, the plaintiff will have to prove that such bias played a role in the particular case at issue. when the biased decision falls within the standard of care, physicians may counter that they reached their decision by way of unbiased reasoning. this will shift the burden of proof back to the patient who will have to prove that an unbiased physician would have made a different decision, one that would have prevented the patient’s injury.114 of course, proving causation, even with the evidence of bias, still presents a potentially insurmountable hurdle. as mentioned above, when the physician’s conduct deviates from the standard of care, the patient is entitled to recovery due to medical malpractice regardless of any influence from racial bias. in cases where the care was not substandard, but was merely suboptimal, the plaintiff may still have a difficulty proving that the optimal care would have prevented harm, especially in cases, where certain treatment choices are never certain to be effective over others. in such cases, the patient could wisely argue, based on the “loss of chance” doctrine, that a physician’s negligent recommendation or prescription denied the patient of a better chance at a cure or higher quality of life.115 this may be the only approach for a scd patient denied opioids by an emergency department physician based on the patient’s race and an assumed predisposition for addiction. of course, in all of these cases for physician liability, the battle is certainly uphill at best, and patients will first face the obstacle of finding an attorney willing to take a case with such a small chance of success. 2.2 – civil rights liability116 recognizing the numerous issues a plaintiff faces when alleging that a 112. id. at 415. 113. d.h. v. chi. hous. auth., 746 n.e.2d 274, 277 (ill. app. 2001) (holding that deletion was insufficient to preserve patient privacy); see also pusateri v. fernandez, 707 so. 2d 892, 893 (fla. dist. ct. app. 1998) (holding that even if information is de-identified, the plaintiff must still prove the information’s relevance to be admissible evidence). 114. crossley, supra note 69, at 261. 115. margaret t. mangan, comment, the loss of a chance doctrine: a small price to pay for human life, 42 s.d. l. rev. 279, 290-92 (1997) (identifying jurisdictions that recognize the loss of chance doctrine). 116. this discussion only focuses on title vi claims as the equal protection clause also requires intentional discrimination for a private right of action, but only applies to government action. 106 indiana health law review [vol. 21:83 physician violated industry specific professional obligations in acting under the influence of racial bias, it may be more appropriate to allege violations of a patient’s civil rights by taking the medical professional standards of care out of the equation due to the universal applicability of civil rights protections. 2.2.1 – title vi a patient may allege that in letting the patient’s race influence the physician’s decision, the physician violated title vi of the 1964 civil rights act. title vi provides that “[n]o person in the united states shall, on the ground of race, color, or national origin, … be subjected to discrimination under any program or activity receiving federal financial assistance.”117 where title vi authorizes federal agencies to impose regulations to enforce these rights, many agencies have prohibited policies that are even just facially neutral when the practice has an adverse disproportionate impact on racially defined groups.118 health care providers and health care facilities are governed by the regulations set by the department of health and human services, an agency which has imposed such disparate impact regulations. specifically, a recipient, . . . may not, directly or through contractual or other arrangements, utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their race, color, or national origin, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program as respect to individuals of a particular race, color, or national origin . . . .119 essentially every hospital falls subject to these regulations due to the creation of the medicare program.120 however, since title vi was used to fight racial segregation in hospitals, modern uses of title vi have been met with mixed results.121 thankfully, because the majority of u.s. physicians receive at least some medicare and medicaid reimbursements, those physicians have been interpreted as recipients of the “federal funding assistance” and have thus been subjected to the same prohibitions against discriminatory practices.122 while certain private physicians do not receive “federal funding assistance” the majority of physicians working out of state run emergency departments, such as the ones 117. 42 u.s.c. § 2000d (1964). 118. sidney d. watson, reinvigorating title vi: defending health care discrimination it shouldn’t be easy, 58 fordham l. rev. 939, 948-55 (1990). 119. 45 c.f.r. § 80.3 (2001). 120. sidney d. watson, health care divided: race and healing a nation, j. legal med. 21:4, 601-608 (2000) (explaining the interrelation of medicare and title vi enforcement). 121. crossley, supra note 69, at 254 (discussing the successful challenges brought against discriminatory admission practices and yet the unsuccessful actions against hospital closures having a similarly disparate impact). 122. howe v. hull, 874 f. supp. 779, 789 (n.d. ohio 1994) (discussing the significance of physicians’ receipt of medicare and medicaid funds). 2024] the medical and legal plight of sickle cell patients 107 which scd patients would encounter, certainly do fall subject to the regulations from title vi.123 better yet, the prohibitions against discriminatory actions by physicians and facilities receiving “federal funding assistance” extend not only to the patients covered by medicare and medicaid, but also to all of their patients.124 thus, having experienced discrimination by their doctors, patients could either seek injunctive relief against the “real or immediate threat that the [patient] will be wronged again”125 or prove intentional discrimination in pursuit of monetary damages.126 the claim will depend on whether the patient is claiming that the physician acted based on personal prejudice or that the physician acted in compliance with a discriminatory policy. taking the latter approach, a scd patient could raise a disparate impact claim arguing that the doctor, in treating all patients complaining of pain the same, according to hospital policy, failed to recognize the increased risk that a member of the black patient population would be more likely be suffering from legitimate pain syndromes due to vaso-occlusive crises than a white patient exhibiting similar symptoms. still, while some decisions may be guided by hospital policy, the majority of physician-made decisions are made on a patient-by-patient basis.127 nevertheless, where it was previously a challenge just to prove discrimination, now the patient must also prove that discrimination was intentional.128 to prove such intentional discrimination, a plaintiff could support the claim with direct or circumstantial evidence. direct evidence would be, for example, a statement made to a colleague or included in the patient’s chart by the emergency physician who withheld pain medication to a scd patient because of race.129 of course, this kind of evidence is rare as physicians sensitive to their own prejudices are unlikely to record evidence of such, and ignorant physicians would have no reason to report considerations of which they had no awareness. 123. see sara rosenbaum et al., u.s. civil rights policy and access to health care by minority americans: implications for a changing health system, 57 med. care research & rev. 236, 255-56 (2000). 124. grimes v. superior home health care of middle tenn., inc., 929 f. supp. 1088, 1091-92 (m.d. tenn. 1996). 125. atakpa v. perimeter ob-gyn assocs., 912 f. supp. 1566, 1573 (n.d. ga. 1994) (asserting that injunctive relief can only be sought after satisfying standing requirements). 126. guardians ass’n v. civil service comm’n, 463 u.s. 582, 600 (1983). cf. ferguson v. city of phoenix, 931 f. supp. 688, 697 (d. ariz. 1996) (supporting monetary damages only where proof of intentional discrimination). 127. crossley, supra note 69, at 282. 128. infra section 2.2.2, where i discuss the need for intentional discrimination for a private action as only the federal government is vested with the power to regulate against unintentional discrimination that creates a disparate impact. 129. slack v. havens, 522 f.2d 1091, 1093 (9th cir. 1975) (providing an example of the kind of satisfactory direct evidence in the supervisor’s statement that “colored people were hired to clean because they clean better”). 108 indiana health law review [vol. 21:83 therefore, patients often have to rely solely on circumstantial evidence. circumstantial evidence would allow the trier of fact to infer the existence of race-based differential treatment from directly proven facts.130 essentially the plaintiff would ask the trier of fact “to conclude that discrimination is the most plausible explanation for a particular proven set of facts.”131 where the supreme court established the well-known mcdonnell douglas burden-shifting paradigm132 in an employment discrimination case under title vii of the civil rights act, courts have since adapted this paradigm to title vi statutory claims.133 thus, using the mcdonnell douglas burden-shifting paradigm adapted to prove a title vi claims, the scd plaintiff would likely carry the initial burden under the statute of establishing a prima facie case of racial discrimination. this may be done by showing (i) that [the patient] belongs to a racial minority; (ii) that he [justifiably asked for pain medications] (iii) that, despite his [qualifying presentation], he was [denied]; and (iv) that, after his [denial], [the physician continued to prescribed medications to] persons of complainant’s qualifications . . . . the burden then must shift to the [physician] to articulate some legitimate, nondiscriminatory reason for the [denial] . . . . [even if the physician articulates such a reason], the inquiry must not end here . . . . [the plaintiff must] be afforded a fair opportunity to show that [the physician’s] stated reason . . . was in fact pretext.134 therefore, where a scd patient cannot provide direct evidence of physicians withholding opioids due to the patient’s race, the patient may seek to show that when white patients complained of similar pain intensity, physicians would prescribe opioids. the patient could satisfy the burden of showing a prima facie case of discrimination by offering statistical proof that such a physician tended to only prescribe opioids for non-black patients presenting in the emergency department.135 nevertheless, the physician will have the opportunity to argue that the 130. harris v. marsh, 679 f. supp. 1204, 1279 n.120 (e.d.n.c. 1987) (citing radomsky v. united states, 180 f.2d 781, 783 (9th cir. 1950)) (“circumstantial evidence is that which establishes the fact to be proved only through inference based on human experience that a certain circumstance is usually present when another certain circumstance or set of circumstances is present. direct evidence establishes the fact to be proved without the necessity for such inference.”). 131. crossley, supra note 69, at 283. 132. mcdonnell douglas corp. v. green, 411 u.s. 792, 802-05 (1973). 133. mckie v. n.y. univ., no. 94 civ. 8610, 2000 wl 1521200, at *3 n.1 (s.d.n.y. oct. 13, 2000). 134. mcdonnell douglas corp., 411 u.s. at 802, 804. 135. ann. c. mcginley, !viva la evolucion!: recognizing unconscious motive in title vii, 9 cornell j. l. & pub. pol’y 415, 465-66 (2000) (evidencing how the government needed to demonstrate “by a preponderance of the evidence” that an employer intentionally acted on racial bias). 2024] the medical and legal plight of sickle cell patients 109 physician withheld pain medications because of non-race-based motives such as the patient appearing intoxicated, or the patient exhibiting “drug-seeking behaviors,” or based on hospital policy prohibiting proscribing pain medication to patients before they meet certain criteria. at this point, the patient would have one last opportunity to prove such physician excuses were mere pretext for discrimination.136 of course, to support any of the plaintiff’s claims, the plaintiff will again face the obstacle of getting supported records past privilege exceptions to discovery. however, where peer-review records are ordinarily privileged, courts in recent cases have found that “the medical peer review privilege does not prevent discovery of peer review records in federal actions alleging civil rights violations.”137 one court has gone so far as to reason that [t]he evidence [the plaintiff] seeks is crucial to his attempt to establish that he has been the subject of disparate treatment on the basis of race and ethnicity. to prove his allegations of disparate treatment, [the plaintiff] must compare the proceedings in his case to those involving similarly situated [plaintiffs]. the interest in facilitating the eradication of discrimination by providing perhaps the only evidence that can establish its occurrence outweighs the interest in promoting candor in the medical peer review process.138 alas, because medicine is undoubtedly an art as much as it is a science, the physician will likely have less difficulty proving that race was only a factor and not the prevailing motive, no matter the inferences drawn from the plaintiff’s circumstantial evidence. 2.2.2 – intentionality alas, even if the plaintiff can offer ironclad proof of discrimination, the discrimination needs to have been intentional as the u.s. supreme court recognizes no private right of action exists to enforce against unintentional discrimination.139 the question still remains as to what would satisfy “intentional discrimination.” perhaps a physician consciously considering race when choosing a treatment regimen would suffice. perhaps a physician deciding based on statistics from racialized medical research would be sufficiently intentional 136. mcdonnell douglas corp., 411 u.s. at 805 n.18 (“[the plaintiff] must be given a full and fair opportunity to demonstrate by competent evidence that whatever the stated reasons [for the defendant’s actions], the decision was in reality racially premised.”). 137. mattice v. mem’l hosp. of south bend, 203 f.r.d. 381, 384-85 (n.d. ind. 2001) (admitting discovery of peer review records in ada case). 138. virmani v. novant health inc., 259 f.3d 284, 289 (4th cir. 2001). 139. alexander v. sandoval, 532 u.s. 275, 286 (2001) (stating no private right of action exists to enforce disparate impact regulation, as there is only a private right of action against intentional discrimination). 110 indiana health law review [vol. 21:83 discrimination. in this area’s seminal work, the id, the ego, and equal protection: reckoning with unconscious racism,140 charles lawrence argues that modern racism is embodied more in conscious stereotyping than in conscious bigotry.141 traditional notions of intent do not reflect the fact that decisions about racial matters are influenced in large part by factors that can be characterized as neither intentional in the sense that certain outcomes are self-consciously sought nor unintentional in the sense that the outcomes are random, fortuitous, and uninfluenced by the decision maker’s beliefs, desires, and wishes.142 and while lawrence examined the liability for unintentional bias in the equal protection analysis, “the issue of whether unconscious discrimination might qualify as intentional discrimination sufficient to show a violation of title vi and other spending clause legislation has not been extensively studied.”143 nevertheless, a plaintiff could argue that providers who choose to accept federal funds should justifiably be held to the high standard of self-policing to avoid any “unconscious” or “negligent” discrimination. of course, courts have yet to hold physicians to such a high standard. now where federal civil rights laws require intentional discrimination for a private right of action, there may be a chance of holding providers liable for unintentional discrimination having a disparate impact under state civil rights laws. state civil right statutes have been construed to apply universally and to supersede rights to religious freedoms when upholding such freedoms would immunize a provider who violates a patient’s civil rights.144 without precedent addressing such a legal strategy, courts may defer to federal interpretations requiting intentional discrimination. however, where states have implemented broader and more fundamental protections than federal protections, judges have recognized that such protections supplant the federal laws and thus require an independent interpretation that effectuates the particular intent of the state and its people.145 for example, florida statute section 760.08 provides that “[a]ll persons are entitled to the full and equal enjoyment of the goods, services, facilities, 140. charles r. lawrence, the id, the ego, and equal protection: reckoning with unconscious racism, 39 stan. l. rev. 317, 317 (1987). 141. crossley, supra note 69, at 287 142. lawrence, supra note 140, at 322. 143. watson, supra note 18,.at 978. 144. see n. coast women’s care med. grp., inc. v. super. ct., 189 p.3d 959 (cal. 2008) (holding that a physician’s constitutional right to free exercise of religion does not exempt the physician from affording patients their civil rights under a broad state law, where a physician refused to assist in fertility procedures for a homosexual couple). 145. see weaver v. myers, 229 so.3d 1118 (fla. 2017) (finding that where the florida constitution memorialized a right to privacy, not explicitly granted by the federal constitution, it could only be concluded that the right had a much broader scope). 2024] the medical and legal plight of sickle cell patients 111 privileges, advantages, . . . without discrimination or segregation on the ground of race, color, national origin, sex, pregnancy, handicap, familial status, or religion.” such all-encompassing language could be used as the basis for arguing that a physician has violated a patient’s right by using that patient’s race as a determining factor when it plays no physiological significance, thus making any race-based assumptions, intentional or unintentional a violation the patient’s civil rights under the state law. still, judges may have a difficult time fully separating the concept of medical professional responsibility from the notion of a universal duty to observe the civil rights of others. 2.2.3 – judicial reluctance to finding liability courts are potentially hesitant to hold physicians liable for what appears to be merely poor-quality care due to the patient’s race, versus objectively negligent care.146 however, it is more likely that similar to courts’ aversion to handling cases of political question, federal courts have been reluctant to question professional medical judgement. when determining the appropriate level of deference to afford to treating physicians, the court in lesley v. he man chie sought a middle ground between “a rule giving physicians complete deference and a rule requiring a full-fledged inquiry into their diligence.”147 still, most courts have sided with the more deferential rule when it comes to questioning physicians’ discretion.148 additionally, courts have been loath to impose federal standards upon what they often deem is essentially medical malpractice, and thus a matter for the states to govern. and therefore, should a plaintiff convince a federal court in a civil rights case of the inferiority of the treatment, the court may dismiss the case as one better suited for as state court under that state’s medical malpractice law.149 thus patients must depend on federal agencies such as the department of health and human services to enforce disparate impact claims against unintentional discrimination, despite the agency’s failure to even define the meaning of “discrimination” in the context of health care. 2.3 – approach to substantive due process claims there is a small possibility for scd patients to bring a substantive due 146. scholars have reasoned that where race contributes to a patient receiving superior care, there would be no action brought or liability imposed. therefore, when a patient argues that the delivered care was sub-par, courts may still force plaintiffs to show that the care was so sub-par to the point that it was sub-standard to hold physician liable for negligent treatment, treatment that would have been deemed negligent regardless of the raced-based motivations. see 48 vill. l. rev. at 291. 147. lesley v. he man chie, 250 f.3d 47, 53 (1st cir. 2001). 148. id. at 55. 149. bryant v. madigan, 84 f.3d 246, 249 (7th cir. 1996) (finding that federal statutes protecting civil rights did not create “federal malpractice claims”). 112 indiana health law review [vol. 21:83 process claim on the grounds that physicians, in withholding the appropriate opioid treatment regardless of the patient’s race, are violating scd patients’ rights. when it came to interpreting substantive rights to contraception, abortion and same-sex marriage, the u.s. supreme court had to first take a very creative look at the constitution before recognizing these “rights”.150 of course, courts are unlikely to find any concrete right to opioids, especially given the current state of emergency of addiction. still, washington v. glucksberg, although unsuccessful, may have set the groundwork for asserting a right to use opioids in a more abstract sense of a right.151 glucksberg questioned whether people had a right to physician-assisted suicide, when a patient challenged the washington state law prohibiting such practices.152 the supreme court answered in the negative, reasoning that suicide has long been condemned and that any new bans had repeatedly been affirmed on review.153 nevertheless, one concurring opinion may point towards the best angle for challenging denials of opioid prescriptions for scd patients regardless of the patient’s race. justice breyer postulated that the potential substantive right was incorrectly articulated suggesting that instead of a fundamental right to “suicide” or even “physician-assisted suicide” that people do have a right to “die with dignity.”154 analogizing glucksberg to a case for opioid use, the plaintiff could argue that instead of a right to opioids, that patients have a right to be free from undue suffering. on such grounds, the patient would argue that because opioids are the mainstay treatment for patients experiencing vaso-occlusive crisis, that physicians withholding this treatment are inflicting undue suffering. if such an argument proves successful, patients could look to extend the precedent to other pain syndromes or even to other pain management such as experimental treatments, or federally prohibited, but state approved, medical cannabis.155 alas, despite the relatively large patient population suffering from scd in the u.s. alone, it is unlikely these patients will find bringing any of the above actions as worthwhile measures. 150. see griswold v. connecticut, 85 s. ct. 1678 (1965) (holding that the right to privacy was implied from the penumbras of the bill of rights); see also planned parenthood v. casey, 112 s. ct. 2791 (1992) (recognizing no right to privacy, but the right to define the sweet mysteries of life); see also lawrence v. texas, 123 s. ct. 2472 (2003)(taking an abstract approach when finding a right to private action between consenting adults). 151. washington v. glucksberg, 521 u.s. 702 (1997). 152. id. at 707-08. 153. id. at 716. 154. id. at 790, (breyer, j., concurring). 155. pacher, pál, sándor batkai & george kunos, the endocannabinoid system as an emerging target of pharmacotherapy, 58 pharmacol. rev. 389, 462 (2006) (discussing the analgesic effects of cannabis) https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2241751/ [https://perma.cc/7mkx-drkj]. 2024] the medical and legal plight of sickle cell patients 113 section 3: how can a broken system recover? given the current case precedent and the way race and discrimination are recognized in medicine, it seems unlikely that scd patients will be able to bring about their own change through legal action. it is the department of health and human services’ responsibility to enforce disparate impact regulations. given what is known about race and its place in medical decisions, the department needs to make clear both the irrelevance of race in medical decisions and also how factoring race into medical decisions is inherently discriminatory. 3.1 – better trained physicians make better physicians when it comes to ethical prescribing of opioids in scd, there are three rules responsible physicians should follow. first, physicians should not underprescribe. the hippocratic oath, in its mandate to “do no harm” clearly makes under-prescribing unethical. while over-prescribing is no less ethical given its risks for creating addiction, the current legal and regulatory aims seem to overcorrect in a way that encourages under-prescribing rather than putting an emphasis on appropriate prescribing based on the patient’s actual condition. by imposing new standards156 intended to increase safe opioid prescribing, the federal drug enforcement agency may cause a decrease in all opioid prescribing, because physicians wanting neither the hassle of more training nor the risks in prescribing opioids, may choose not to get trained. this will lead to fewer physicians knowledgeable about proper prescribing practices, further decreasing the numbers available to treat scd patients when they present to their nearest emergency departments in both urban and rural corners of the country. of course, this is not a journey the federal government must take alone. in response to the rising opioid addiction crisis, numerous states have also added to the state-specific training requirements for health care providers who prescribe controlled substances.157 these kinds of training courses are often provided by health care institutions for the convenience of their employed and independently contracted physicians. for the sake of their patients, these institutions would do well to educate their course participants in the importance of recognizing the differences between addiction and pseudo addiction instead of instilling blind fear in prescribing controlled substances altogether. beyond misplaced fear of addiction, evidence shows that underlying racism is also misplaced, as the prevalence of abuse in white patients was significantly 156. press release, obama administration releases action plan to address national prescription drug abuse epidemic: new strategy strikes balance between cracking down on drug diversion and protecting delivery of effective pain management, dea, (april 19, 2011), ondcp public affairs number: 202-395-6618, https://obamawhitehouse.archives.gov/ondcp/news-releasesremarks/obama-administration-releases-action-plan [https://perma.cc/3hjd-7x2e]. 157. fla. stat. § 456.0301(1)(a) (2018) (requiring controlled substance prescribers to complete a new two-hour continuing medical education course in safe prescribing practices). 114 indiana health law review [vol. 21:83 higher than rates of abuse in black patients in the year 2003 (6.9% to 3.7%).158 these statistics may be due to historical aversion to prescribing opioids to black patients, thus making white patients more likely to receive the opioid and then to develop addictions. nevertheless, given that there is no race-based predisposition to addiction and the black patient population’s persistent distrust of physicians, it is likely safer to prescribe based on a patient-by-patient basis irrespective of the patient’s race. in particular, scd patients may require higher doses than inexperienced physicians are comfortable prescribing.159 scd patients have higher opioid dose needs and different opioid responses due to tolerance160 and altered pharmokinetics.161 this altered response is likely due to the multiple exposures to and chronic use of opioids, as most adults with scd have experienced numerous pain crises, many of which require hospitalization and opioid prescribing.162 thus, scd patients exhibiting symptoms of opioid dependence or withdrawal, may be wrongfully labeled as addicts. any further under-treatment will only exacerbate the symptoms of pseudo addiction in scd patients and increase these patients’ distrust in their physicians.163 due to negative experiences with health care providers, scd patients actually avoid the emergency department until severe symptoms force patients to use emergency services, further exacerbating their pseudo addiction presentation and worsening their quality of life.164 physicians need to recognize that scd is a chronic pain syndrome and should thus be treated as such. in 1992, the annals of internal medicine published a cohort study suggesting that scd pain should be treated more like cancer pain with more long-term pain treatment regimens.165 with time, physicians have come to accept the need for prescribing both long-acting and short-acting treatments. however, the willingness to prescribe opioids for non-cancer pain extended 158. samhsa, overview of findings from the 2003 national survey on drug use and health, office of applied studies, nsduh series h-24, dhhs publication no. sma 04-3963 (2004). https://www.datafiles.samhsa.gov/dataset/national-survey-drug-use-and-health-2003nsduh-2003-ds0001 [ttps://perma.cc/jam7-z7jn]. 159. smith, supra note 7, at 142. 160. judith e. beyer, judging the effectiveness of analgesia for children and adolescents during vaso-occlusive events of sickle cell disease, 19 j. pain symptom mgmt. 63, 72 (2000). 161. stacy s. shord et al., the pharmacokinetics of codeine and its metabolites in blacks with sickle cell disease, 65 euro. j. of clinical pharmacol. 654, 655 (2009). 162. imoigele p. aisiku et al., comparisons of high versus low emergency department utilizers in sickle cell disease, 53 annals of emerg. med. 587, 593 (2009). 163. karen miotto, diagnosing addictive disease in chronic pain patients, 37 psychosomatics 224 (1996). 164. nigel murray & alison may, painful crises in sickle cell disease -patients’ perspectives, 297 bmj 453 (1988). 165. daniel brookoff & rosemary polomano, treating sickle cell pain like cancer pain, 166 annals of int. med. 364, 368 (1992). 2024] the medical and legal plight of sickle cell patients 115 beyond scd pain and contributed to the current opioid overprescribing and addiction crisis. thus, the second ethical principle for opioid prescribing instructs physicians to monitor and respond to opioid side effects and diminishing effectiveness. opioids can cause hallucinations, seizures, severe sedation to the point of coma and death, among other serious side-affects. the initial administration of opioids thus requires careful titration up to the appropriate dose, as most of these sideeffects are manageable upon their presentation.166 scd patients are more likely to experience these adverse effects and more quickly develop tolerance when their condition is treated as acute episodes in isolation rather than a chronic pain syndrome.167 nevertheless, because opioid misuse is harder to recognize in patients with chronic pain syndrome, the third ethical principle for responsible prescribing is that physicians must diligently recognize opioid addiction. while the diagnostic and statistical manual for mental disorders has evolved its diagnostic criteria for opioid use disorders, its literal application to scd patients would likely designate most patients as abusers due to their high tolerance and propensity for withdrawal symptoms when under-treated.168 of course, scd patients are not immune to opioid addiction169 and misuse, and thus physicians should assess patients for their risk of addiction, not based on race, but based on observing aberrant drugrelated behaviors pursuant to accepted diagnostic standards. 3.2 – the resources exists, just not enough of course, responsible opioid prescribing requires adequate numbers of knowledgeable physicians treating scd patients. this is why scd patients need the kind of continuity of care that comes from regular visits with a doctor who specializes in their disease pathology such as a hematologist. a long-term physician-patient relationship can engender trust and allow both sides to communicate openly with the other to ensure the best treatment outcomes. a hematologist following an scd will know when to increase doses and when the patient is succumbing to any of opioid’s adverse effects despite appropriate prescribing practices. as discussed previously, because hematologists are more well-versed in 166. principles of analgesic use in the treatment of acute pain and cancer pain, (american pain society ed., 5th ed. 2003). 167. smith, supra note 7, at 143. 168. am. psychiatric ass’n, diagnostic and statistical manual of mental disorders 608-15 (5th ed. 2013); see also dsm-5 clinical diagnostic criteria for opioid use disorder, british col. ctr. on substance use, https://www.bccsu.ca/wp-content/uploads/ 2017/08/dsm-5.pdf [https://perma.cc/y78t-5bpq] (presenting the new diagnostic criteria under the dsm5). 169. james l. levenson et al., alcohol abuse in sickle cell disease: the pisces project, 16 am. j. on addiction 383, 388 (2007). 116 indiana health law review [vol. 21:83 scd, they are less likely to assume their patients are addicts compared with physicians with far less specialized experience.170 hematologists will have a better chance of separating patient race from the scd condition, when the majority of such patients are black. instead of comparing their black patients with white patients, hematologists would more likely compare their black patients to each other, not as black patients, but as scd patients, when considering different treatment approaches and assessing the potential for abuse. additionally, there are specialized treatment centers focused on the needs of scd patients.171 while these treatment centers provide scd-specific comprehensive care, the number of centers is limited, and there are not enough to provide access to scd patients across the country.172 thus, access to primary care providers, improved coverage of coordinated medical homes, and implementing chronic care models, may more realistically address the needs of the average scd patient.173, when it comes to treating relatively uncomplicated vaso-occlusive crises, reports show that day hospitals are an effective health service delivery mechanism, and serve as less expensive alternatives than visits to emergency departments turning into an extended hospitalization.174 however, when it comes to insurance coverage, a significant portion of child and adult scd patients rely on medicaid coverage for their everyday health care needs. 175 among hospitalizations for scd patients, one study showed that sixtysix percent were covered by medicaid as the primary payer.176 despite the affordable care act’s mandatory coverage of preexisting conditions, there are still covered scd patients who either do not know about their particular health care needs and the availability of preventative services to address those needs, or they simply choose to abstain from health care services given the previously mentioned distrust in the black patient population.177 whatever the reason, studies 170. the management of sickle cell disease, nih publ. no. 02-2117(2002). 171. imoigele p. aisiku et al., patient satisfaction in specialized vs. non-specialized adult sickle cell care centers, 99 j. nat’l med ass’n 886, 890 (2007). 172. yusuf et al., sickle cell disease: the need for a public health agenda, am. j. preventative. med. 41(6s4), s376-83 (2011). (doi: 10.1016/j.amepre.2011.09.007. pmid: 22099361). 173. american academy of pediatrics, section on hematology/oncology, committee on genetics, health supervision for children with sickle cell disease, 109 pediatrics 526, 535 (2002); s. d. grosse et al., models of comprehensive multidisciplinary care for individuals in the united states with genetic disorders, 123 pediatrics 407, 412 (2009). 174. lennette j. benjamin et al.,, sickle cell anemia day hospital: an approach for the management of uncomplicated painful crises, 95 blood 1130, 1136 (2000). 175. michelle mayer et al.,hospital resource utilization among patients with sickle cell disease, 14 johns hopkins j. hcpu 122, 135 (2003). 176. claudia a. steiner & jeffrey l. miller, sickle cell disease patients in u.s. hospitals, agency for healthcare rsch & quality (2004), www.hcup-us.ahrq.gov/reports/statbriefs/ sb21.pdf. 177. amanda m. brandow et al.,, hydroxyurea in children with sickle cell disease: practice patterns and barriers to utilization, 85 am. j. hematol. 611, 613 (2010). 2024] the medical and legal plight of sickle cell patients 117 have shown that scd patients utilize primary care providers and specialists at a suboptimal rate.178 thus, in spite of alternative sources for health care services, scd patients continue to present to emergency departments far more than the general population. 3.3 – emergency physicians need to step up for one reason or another, scd patients heavily depend on emergency departments and thus deserve responsible care from emergency physicians. emergency department physicians often implement triage techniques to categorize numerous patients into cases that can wait, cases that need immediate attention, and cases that are beyond help. this may encourage emergency department physicians to quickly prescribe a less effective analgesic to scd patients to avoid the necessary, but time-consuming, investigation or the risk of enabling undiagnosed addiction. however, it is far more inappropriate for emergency physicians to pass the buck to another long-term care provider, when scd patients present in vasoocclusive crisis needing immediate care of the appropriate nature. this is why more emergency department physicians need the necessary training to help guide them to make better decisions for scd patients and empower them to make these decisions despite time constraints in a busy emergency department. otherwise, scd patients will continue to go under-treated or altogether mistreated by their emergency department physicians. on the other side, undertrained emergency department physicians will likely form biased impressions based on anecdotal encounters with of scd patients. this will lead to more physicians presuming scd patients are addicts, and because the majority of scd patients are black, it will only add to the biased thinking that black patients are more likely to be addicts than white patients. therefore, better efforts to train the physicians most likely to encounter scd patients could go a long way to ensuring better treatment, more balanced awareness, and even less opioid addiction. 3.4 – more efficient opioid use is possible despite the appropriateness of opioids for treating vaso-occlusive pain crises179 in scd patients, there are numerous new treatment mechanisms that could improve the efficacy of opioids and thus decrease the needed doses. modern approaches either seek to target the pathobiology underlying scd pain (disease-modifying) or seek to develop new pain relievers specific to the central nervous system.180 studies observing the effects of treatments aimed at decreasing 178. jean. l. raphael et al., health care utilization and expenditures for low income children with sickle cell disease, 52 pediatric blood cancer 263, 267 (2009). 179. samir k. ballas et al, sickle cell pain: a critical reappraisal. 120 blood 3647, 3656 (2012). 180. huy tran et al., targeting novel mechanisms of pain in sickle cell disease, 130 blood 118 indiana health law review [vol. 21:83 leukocyte activity found that this treatment led to significant reductions in pain crises suggesting that leucocytes may contribute to chronic pain in scd patients.181 furthermore, numerous mouse model studies have shown that activated leukocytes may directly or indirectly contribute to chronic as well as acute scd pain and thus medications downgrading their activity may help to alleviate pain.182 when it comes to addressing neurogenic inflammation and pain, scd patients have higher levels of circulating tryptase, a mast cell degranulation marker, suggesting that in instigating inflammatory pathways, mast cells contribute to scd pain.183 and while, cromolyn, a mast cell stabilizer, had no pain-relieving effects on its own, cromolyn’s use in conjunction with opioids, decreased the needed doses of morphine for ameliorating chronic pain.184 additionally, where simvastatin, a typical cholesterol lowering drug, showed signs of decreasing mast cell activity inducing factors, use of simvastatin in scd patients lead to decreased frequency of pain and reduction in the needed doses for opioids, despite having no effect on the reported intensity of scd pain.185 as much of pain intensity is perceived by the central nervous system, treatment mechanisms which decrease this significant pain receptor may add to overall quality of life in scd patients. cannabinoids have well documented analgesic effects186 in the central nervous system, and thus ongoing trials187 may prove the benefits of administering vaporized cannabis to address chronic scd pain in conjunction with the disease-modifying mechanisms. therefore, there are many novel ways of approaching pain management for scd patients. given these various opioid-sparing mechanisms, any push to decrease opioid prescriptions should also champion research into these pharmaceutical alternatives. otherwise, scd patients will perhaps go under-treated and continue to suffer the consequences due to historical overprescribing for other chronic pain syndromes. 2377, 2381 (2017). 181. kenneth. i. ataga et al., crizanlizumab for the prevention of pain crises in sickle cell disease, 376 n. engl. j. med. 429,439 (2017). 182. grace chen et al., heme-induced neutrophil extracellular traps contribute to the pathogenesis of sickle cell disease, 123 blood 3818, 3827 (2014). 183. nina kuei et al., characteristics and potential biomarkers for chronic pain in patients with sickle cell disease, 126 blood 986 (2015). 184. lucile vincent et al., mast cell activation contributes to sickle cell pathobiology and pain in mice, 122 blood 1853, 1862 (2013). 185. carolyn hoppe et al., simvastatin reduces vaso-occlusive pain in sickle cell anaemia: a pilot efficacy trial, 177 br. j. haematol 620, 629 (2017). 186. jaseena elikkottil et al.,the analgesic potential of cannabinoids, 5 j. opioid mgmt. 341, 357 (2009). 187. cannabinoid-based therapy and approaches to quantify pain in sickle cell disease, nct01771731, university of california – san francisco (2017) https://clinicaltrials.gov/ study/nct01771731 [https://perma.cc/f9nh-qr2t] 2024] the medical and legal plight of sickle cell patients 119 3.5 – expect and demand more from medicine and the law lastly, the medical profession’s standard of care needs to evolve to recognize the harmful effects of factoring race into medical decisions. the apparent lack of consensus as the scientific irrelevance of race has allowed racialized research to continue, has emboldened some physicians to discriminate and enabled others to exercise unconscious bias without any legal accountability. the department of health and human services has failed to enforce regulations against disparate impacts in the health care leaving black patients to suffer from discrimination in addition to their medical conditions until their mistreatment rises to the level of clear medical malpractice or intentional discrimination. it is uncertain whether these issues should first be attacked by the medical or the legal community. while it is also unclear whether a joint approach to tackling racial disparities in health care would prove successful, it is clear that current adversarial relationships between medical and legal professionals only further hinder progress. when doctors fear malpractice liability for over-prescribing, they either tend to under-treat or they refuse to satisfy the requirements to prescribe and thus avoid treating patients presenting with pain altogether. legislators may recognize the opioid crisis as one of monumental importance but miss the need for a greater understanding of the scientific complexities of opioid action and responsible prescribing practices. along either well-intentioned path, patients and particularly black scd patients receive lower quality care and thus needlessly suffer further. 1.3.1 – racialized research created a hard habit to quit 1.3.2 – get race out of medical decisions 2.1.2 – informed consent readers of tea-leaves: a common sense good-faith defense for private party section 1983 defendants in the seventh circuit brad taylor* for better or worse, private actors have an increasingly prominent hand in providing historically governmental services in the united states. the privatization of public function is perhaps most apparent in prisons.1 private citizens in many prisons are now charged with overseeing prison operations, providing security as guards, and offering medical services to inmates.2 government service providers face the prospect of civil liability under 42 u.s.c. § 1983 by acting “under color of any statute, ordinance, regulation, custom, or usage, of any state or territory or the district of columbia.”3 despite the threat of litigation, public officials are generally able to perform their public functions without fear thanks to the qualified or absolute immunities inherent in the functions they perform.4 in contrast, private citizens performing identical functions do not benefit from those immunity doctrines.5 the united states supreme court, in wyatt v. cole, (wyatt i), held policies favoring the immunity doctrines for public officials do not apply with equal force to private parties.6 the court found “principles of equality and fairness” favored qualified immunity for private actors performing public functions, but did not, alone, justify that extension.7 without immunity, private citizens, accountable under § 1983 for acting under color of law when providing government services, are potentially liable if a law they relied on when providing those services is later deemed * associate attorney, cassiday schade, llp, springfield, illinois. brad taylor wishes to thank toni judnitch for her infinite patience, support, and insight. her feedback, felicity, and friendship make the arduous seem easy and the impossible merely imposing. 1. government privatization: history, examples, and issues, ill. comm’n on gov’t forecasting & accountability, at 14 (2006), https://cgfa.ilga.gov/upload/2006gov_ privatization_rprt.pdf [https://perma.cc/dx4s-2u5a] [hereinafter commission report] (“privatization in corrections has occurred at all levels of government. services provided include the design, build, finance, operation, and maintenance of prisons. beyond that, corrections officials have outsourced such services as food service, health service, and mental health services in prisons that are run by the public. in 2005, thirty-five states housed prisoners in privately owned or operated prisons.”). 2. id. 3. 42 u.s.c. § 1983 (1994). 4. see owen v. city of independence, 445 u.s. 622, 637 (1980); see also harlow v. fitzgerald, 457 u.s. 800, 807 (1982). 5. wyatt v. cole (wyatt i), 504 u.s. 158, 169 (1992). 6. id. at 168-69 (“accordingly, we have recognized qualified immunity for government officials where it was necessary to preserve their ability to serve the public good or to ensure that talented candidates were not deterred by the threat of damages suits from entering public service.”); see also mitchell v. forsyth, 472 u.s. 511, 526 (1985) (holding immunity is intended to prevent “distraction of officials from their governmental duties, inhibition of discretionary action, and deterrence of able people from public service”) (quoting harlow, 457 u.s. at 826). 7. wyatt i, 504 u.s. at 168. 128 indiana health law review [vol. 19:127 unconstitutional. the court, however, did not foreclose the prospect of an affirmative “goodfaith defense”8 to § 1983 liability.9 specifically, the court intentionally left open the possibility that a private party, performing a public function and therefore susceptible to liability under § 1983, could affirmatively raise good-faith reliance on state or federal law as a defense to liability.10 on remand, the u.s. court of appeals for the fifth circuit held a private § 1983 defendant could raise the good-faith defense and cited support in the concurring and dissenting justices’ opinions.11 since 1993, every circuit court to address the issue has similarly ruled in favor of the good-faith defense.12 most recently, the seventh circuit approved the good-faith defense for private actors liable under § 1983 torts committed while “acting under color of state law.”13 the seventh circuit noted that the defense was justified because private § 1983 defendants had to “abide by, and be able to rely on, what the law is, rather than what the readers of tea-leaves predict that it might be in the future.”14 it remains to be seen how this defense will take shape in the seventh circuit, either in theory or in practice. this article will examine the distinction between qualified immunity and a good-faith defense in § 1983 litigation. then, it will analyze how the good-faith defense has been implemented in other circuits, especially in light of the policy concerns the defense is intended to address. further, it will suggest how the defense can be practically utilized while 8. good-faith defense in a § 1983 suit is distinct from and not to be confused with the goodfaith defense against fraud. in a fraud case, the state has the burden to show that the defendant intended to defraud another party – by showing that he or she did not have the requisite intent to defraud, a defendant can defeat the charge. see, e.g., united states v. casperson, 773 f.2d 216, 223 (8th cir. 1985). 9. wyatt i, 504 u.s. at 169 (“[w]e do not foreclose the possibility that private defendants faced with § 1983 liability under lugar v. edmondson oil co. [] could be entitled to an affirmative defense based on good faith and/or probable cause or that § 1983 suits against private, rather than governmental, parties could require plaintiffs to carry additional burdens.”) (internal citation omitted). 10. id. 11. wyatt v. cole (wyatt ii), 994 f.2d 1113, 1118-19 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993) (“we accordingly hold that private defendants sued on the basis of lugar may be held liable for damages under § 1983 only if they failed to act in good faith in invoking the unconstitutional state procedures, that is, if they either knew or should have known that the statute upon which they relied was unconstitutional.”). 12. see jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994); vector rsch., inc. v. howard & howard att’y p.c., 76 f.3d 692, 699 (6th cir. 1996); clement v. city of glendale, 518 f.3d 1090, 1096-97 (9th cir. 2008); jarvis v. cuomo, 660 f. app’x 72, 75 (2d cir. 2016); janus v. am. fed’n of state, 942 f.3d 352, 363 (7th cir. 2019). 13. janus, 942 f.3d at 367. 14. id. at 366 (emphasis in original); accord with ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1091 (s.d. ohio 2019) (“in short, it is patently unfair to expect private actors to be able to predict the future of constitutional law.”). 2022] readers of tea-leaves 129 advancing the policy principles underlying its creation. lastly, this article will recommend steps seventh circuit courts can take to ensure its viability as an affirmative defense while defining its contours and how states can promote its effective usage through statutory schemes. it also bears noting that, although this article is an academic paper, its authors recognize the fact that the law does not exist in a vacuum. with that in mind, this article will consider the implications of the good-faith defense as it concerns real world litigation, throughout. after all, the good-faith defense is worthy of in-depth study, careful analysis, and thoughtful suggestion precisely because of its considerable impact on judges, litigators, and the parties themselves. i. the distinction between qualified immunity and good-faith defense before examining the modern doctrine of qualified immunity and its distinction from a good-faith defense, it is important to understand the legal context in which this immunity is asserted. typically, a government employee will assert qualified immunity when he or she is named as a defendant in either a 42 u.s.c. § 1983, or a bivens15 suit. section 1983 allows a private party to assert a claim against a state actor for a violation of a federally guaranteed right, while a bivens action allows the same against federal employees. section 1983 is a brief but potent statute: every person who, under color of any statute, ordinance, regulation, custom, or usage, of any state or territory or the district of columbia, subjects, or causes to be subjected, any citizen of the united states or other person within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the constitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceeding for redress, except that in any action brought against a judicial officer for an act or omission taken in such officer’s judicial capacity, injunctive relief shall not be granted unless a declaratory decree was violated or declaratory relief was unavailable. for the purposes of this section, any act of congress applicable exclusively to the district of columbia shall be considered to be a statute of the district of columbia.16 once a plaintiff alleges the government official has violated a federally guaranteed right, the state or federal employee may assert either absolute or qualified immunity as an affirmative defense against civil suits.17 absolute 15. see bivens v. six unknown named agents of fed. bureau of narcotics, 403 u.s. 388 (1971). 16. 42 u.s.c. § 1983. 17. harlow v. fitzgerald, 457 u.s. 800, 807 (1982). 130 indiana health law review [vol. 19:127 immunity is reserved for legislators,18 judges,19 and certain members of the executive branch, like judges20 and the u.s. president.21 qualified immunity, in contrast, protects state and federal executive officials who did not violate “clearly established statutory or constitutional rights of which a reasonable person would have known.”22 whether absolute or qualified immunity applies is a question of function, not position.23 for example, a government employee performing a legislative function will be protected by absolute immunity for that act, but the same official will only receive qualified immunity for a discretionary executive function.24 a private party serving a public function, regardless of the nature of that function, cannot assert absolute or qualified immunity.25 qualified immunity is immunity from suit, not merely damages.26 a defendant must assert qualified immunity as an affirmative defense at the pleading stage, and it will be decided by a judge as a question of law.27 if a court holds the alleged violation was of a clearly established law, then the defendant is not protected by qualified immunity.28 what is “clearly established law” is a very narrow question, and lower courts often struggle to strike the proper degree of specificity between the facts of the case and binding precedent.29 generally, to be clearly established, a court of binding authority in that jurisdiction must have decided a case based on similar facts, such that a reasonable official in the defendant’s position would be on notice “that the alleged conduct ‘was unlawful 18. see eastland v. u.s. servicemen’s fund, 421 u.s. 491 (1975). 19. see stump v. sparkman, 435 u.s. 349 (1978). 20. butz v. economou, 438 u.s. 478, 508-12 (1978). 21. see nixon v. fitzgerald, 457 u.s. 731 (1982). 22. harlow, 457 u.s. at 818. 23. id. at 810. (“moreover, in general our cases have followed a ‘functional’ approach to immunity law.”); see, e.g., gravel v. united states, 408 u.s. 606, 624-25 (1972) (holding only those acts “legislative in nature” are protected by absolute immunity). 24. see harlow, 457 u.s. at 810-11. 25. wyatt v. cole (wyatt i), 504 u.s. 158, 168 (1992). 26. see mitchell v. forsyth, 472 u.s. 511, 526 (1985) (defining qualified immunity as “an entitlement not to stand trial or face the other burdens of litigation”). 27. see saucier v. katz, 533 u.s. 194, 200 (2001) (“where the defendant seeks qualified immunity, a ruling on that issue should be made early in the proceedings so that the costs and expenses of trial are avoided where the defense is dispositive.”). 28. see harlow, 457 u.s. at 818. 29. see ashcroft v. al-kidd, 563 u.s. 731, 741-43 (2011); see also, e.g., white v. pauly, 137 s. ct. 548, 552 (2017) (“today, it is again necessary to reiterate the longstanding principle that ‘clearly established law’ should not be defined ‘at a high level of generality.’”); ziglar v. abbasi, 137 s. ct. 1843, 1867 (2017) (finding that defendants were entitled to qualified immunity); city & cty. of san francisco, calif. v. sheehan, 575 u.s. 600, 610-13 (2015) (reversing the ninth circuit’s denial of qualified immunity to police officer defendants); saucier, 533 u.s. at 209 (“[p]etitioner was entitled to qualified immunity, and the suit should have been dismissed at an early stage in the proceedings.”). 2022] readers of tea-leaves 131 in the situation he confronted.’”30 as such, qualified immunity “protects ‘all but the plainly incompetent or those who knowingly violate the law.’”31 a defendant denied qualified immunity can immediately appeal that decision.32 if, however, a court holds the defendant is protected by qualified immunity, then the case against that defendant is immediately dismissed.33 the strength of qualified immunity as a shield from suit is informed by the policy concerns underlying it. the u.s. supreme court held qualified immunity is necessary to prevent “distraction of officials from their governmental duties, inhibition of discretionary action, and deterrence of able people from public service.”34 although private defendants serve the same functions as their public official equivalents, these policy concerns do not implicate them to the same degree.35 the primary difference between a private party and public official who performs the same function is the cost to the public should they be named as a defendant.36 when a private party is named a defendant, the public is largely unaffected.37 conversely, when public officials are haled into court, they are distracted from performing their duties, discouraged from acting “forcefully and decisively in their jobs” or engaging in public service at all, thus harming the public at-large.38 ultimately, qualified immunity “acts to safeguard government, and thereby to protect the public at large,” and the public officials who enjoy it are merely incidental beneficiaries.39 a good-faith defense, on the other hand, is available to private defendants and does not prevent a suit from proceeding to trial. good faith is a question of fact, not law, and therefore cannot always be determined by a judge early in proceedings. additionally, private defendants cannot merely assert a lack of “clearly established law,” but rather must cite a state or federal law that justified 30. ziglar, 137 s. ct. at 1867 (quoting saucier, 533 u.s. at 202). 31. id. (quoting malley v. briggs, 475 u. s. 335, 341 (1986)). 32. see harlow, 457 u.s. at 807, n.11 (holding denial of qualified immunity is an appealable issue under the collateral order doctrine); see also mitchell v. forsyth, 472 u.s. 511, 530 (1985) (“[a] district court’s denial of a claim of qualified immunity, to the extent that it turns on an issue of law, is an appealable ‘final decision’ within the meaning of 28 u.s.c. § 1291 notwithstanding the absence of a final judgment.”). 33. see saucier, 533 u.s. at 209 (“[p]etitioner was entitled to qualified immunity, and the suit should have been dismissed at an early stage in the proceedings.”). 34. mitchell, 472 u.s. at 526 (quoting harlow, 457 u.s. at 826). 35. wyatt v. cole (wyatt i), 504 u.s. 158, 167-68 (1992). 36. the validity of the assertion that the public is protected by a public official’s use of the qualified immunity, but not by a private party’s use of the same for performing a similar or identical function is debatable, but ultimately beyond the scope of this article. 37. wyatt i, 504 u.s. at 168 (“[u]nlike…government officials performing discretionary functions, the public interest will not be unduly impaired if private individuals are required to proceed to trial to resolve their legal disputes.”). 38. id. 39. id. 132 indiana health law review [vol. 19:127 their actions.40 namely, a private defendant is shielded from liability only if he or she relied in good-faith on a statute that was valid at the time and authorized the defendant’s allegedly tortious conduct.41 that the statute was later ruled unconstitutional is of no consequence, so long as the private defendant neither “knew nor should have known that the statute upon which they relied was unconstitutional.”42 at least one circuit has discarded the objective component of the defense, instead embracing a purely subjective good-faith standard.43 under the subjective standard, a defendant must prove merely that she relied in goodfaith on a presumptively valid law, not that her reliance was reasonable.44 these distinctions separate qualified immunity from a good-faith defense. qualified immunity is not available to private parties and a decision denying qualified immunity can be appealed immediately.45 further, although qualified immunity is never presumed, it is easier to argue because it merely requires a “lack of clearly established law,” as opposed to a reliance on a specific statute. the good-faith defense standard contains objective and subjective components in some jurisdictions,46 or a purely subjective showing in others.47 qualified immunity is always based on an objective, reasonable person standard.48 in its decision denying qualified immunity to private parties, the u.s. supreme court noted policy concerns justified the immunity in regards to public officials but did not apply with equal force to private parties.49 overall, qualified immunity represents the more powerful defensive tool, because it shields defendants from 40. wyatt v. cole (wyatt ii), 994 f.2d 1113, 1118 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993). 41. id. 42. id. 43. jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994) (“these considerations lead us to conclude ‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more demanding objective standard of reasonable belief that governs qualified immunity.”). 44. id. 45. harlow v. fitzgerald, 457 u.s. 800, 807 (1982) (holding denial of qualified immunity is an appealable issue under the collateral order doctrine). 46. wyatt ii, 994 f.2d at 1120, 114 s. ct. at 470. 47. see, e.g., jordan, 20 f.3d at 1277 (“these considerations lead us to conclude ‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more demanding objective standard of reasonable belief that governs qualified immunity.”). 48. ziglar v. abbasi, 137 s. ct. 1843, 1866 (2017) (quoting saucier v. katz, 533 u.s. 194, 202 (2001)). 49. wyatt v. cole (wyatt i), 504 u.s. 158, 167 (1992) (“accordingly, we have recognized qualified immunity for government officials where it was necessary to preserve their ability to serve the public good or to ensure that talented candidates were not deterred by the threat of damages suits from entering public service.”); see also mitchell v. forsyth, 472 u.s. 511, 526 (1985) (holding immunity is intended to prevent “distraction of officials from their governmental duties, inhibition of discretionary action, and deterrence of able people from public service”) (quoting harlow, 457 u.s. at 816). 2022] readers of tea-leaves 133 a suit entirely, instead of mere liability. further, as a question of fact, the merits of a good-faith defense argument must sometimes be left to a jury at the verdict stage of trial, rather than by a judge during pleadings or following discovery. ii. implementation of the good-faith defense a. policy concerns informing the good-faith defense although the good-faith defense does not exist for so lofty a purpose as to “protect the public at large,”50 it still serves worthwhile principles. namely, a good-faith defense to § 1983 suits prevents verdicts that would otherwise run counter to “principles of equality and fairness.”51 at its core, the defense is a commonsense doctrine, nearly rising to the level of truism – an individual should not be held civilly liable for following the law, absent some malicious intent. lacking qualified immunity, private defendants “who innocently make use of seemingly valid state or federal laws would be responsible, if the law is subsequently held to be unconstitutional, for the consequences of their actions.”52 the good-faith defense is intended to prevent this seemingly unjust, and arguably absurd, result. the good-faith defense for private defendants in § 1983 suits should serve “principles of equality and fairness”53 by protecting those who act in good-faith reliance on a statute.54 the reliance element is important to the good-faith defense. a private defendant who knew that a statute was unconstitutional will not be protected by the good-faith defense, because doing so would not serve “principles of equality and fairness.”55 in fact, shielding a bad-faith actor would not only work against the purpose of the good-faith defense, but produce an unjust result. similarly, in many jurisdictions, a private defendant cannot hide behind ignorance of a law’s defects, if the law is obviously unconstitutional.56 although a defendant in such a case would lack malicious intent, allowing unreasonable ignorance to defeat a seemingly valid claim would arguably work an injustice against the otherwise meritorious plaintiff. some have questioned this objective element, however, noting that reliance on a presumptively valid law is 50. wyatt i, 504 u.s. at 168. 51. id. 52. lugar v. edmondson oil co., 457 u.s. 922, 942, n.23 (1982). 53. wyatt i, 504 u.s. at 168. 54. wyatt v. cole (wyatt ii), 994 f.2d 1113, 1118 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993) (“we accordingly hold that private defendants sued on the basis of lugar may be held liable for damages under § 1983 only if they failed to act in good faith in invoking the unconstitutional state procedures, that is, if they either knew or should have known that the statute upon which they relied was unconstitutional.”). 55. wyatt i, 504 u.s. at 168. 56. janus v. am. fed’n of state, 942 f.3d 352, 363 (7th cir. 2019) (quoting wyatt ii, 994 f.2d at 1118, 114 s. ct. at 470). 134 indiana health law review [vol. 19:127 reasonable “as a matter of law.”57 it is also important to note what policy concerns are addressed from the § 1983 plaintiff’s perspective. while qualified immunity protects “all [public officials] but the plainly incompetent or those who knowingly violate the law,”58 the good-faith defense will only shield private defendants who acted in good-faith reliance on a state or federal law.59 this significantly narrows the scope of the defense, compared to qualified immunity. as such, plaintiffs with meritorious claims against culpable defendants, either by virtue of actual awareness of a law’s unconstitutionality or unreasonable ignorance, will still receive favorable judgments. relying on a law, even one deemed unconstitutional, is not generally considered culpable behavior absent an element of malice. as punitive damages are intended “to punish wrongdoers and deter wrongful conduct,”60 this defense prevents an illogical result, namely, punishment of a non-culpable party. unfortunately, plaintiffs with meritorious claims against non-culpable defendants will also lose out on compensatory damages. compensatory damages are intended to compensate victims, not punish tortious behavior like punitive damages.61 some might argue that non-culpable defendants should still be liable for compensatory damages, to avoid an unjust result for the plaintiff. this argument is not without merit, but is ultimately fallacious. compensatory damages are not intended to punish wrongful conduct but are only justified when rooted in wrongful conduct.62 misfortune plagues all and sundry, but in tort law, liability only attaches when the source of that misfortune was defendant’s culpable conduct.63 in addition to equality and fairness, the good-faith defense arguably serves the same policies underlying qualified immunity. qualified immunity is intended to protect the public at large by preventing public officials from being distracted from their public service, discouraged from efficiently exercising their own discretion, or deterred from public service altogether.64 the u.s. supreme court held extending qualified immunity to private defendants performing public 57. wyatt i, 504 u.s. at 174 (kennedy, j., concurring) (“[t]here is support in the common law for the proposition that a private individual’s reliance on a statute, prior to a judicial determination of unconstitutionality, is considered reasonable as a matter of law.”). 58. ziglar v. abbasi, 137 s. ct. 1843, 1867 (2017) (quoting malley v. briggs, 475 u.s. 335, 341 (1986)). 59. wyatt ii, 994 f.2d at 1118, 114 s. ct. at 470. 60. restatement (second) of torts § 901(c) (1979). 61. restatement (second) of torts § 901(a) cmt. a (1979) (“[t]he law of torts attempts primarily to put an injured person in a position as nearly as possible equivalent to his position prior to the tort.”). 62. palsgraf v. long island r. co., 248 n.y. 339, 346 (n.y. 1928) (“the question of liability is always anterior to the question of the measure of the consequences that go with liability. if there is no tort to be redressed, there is no occasion to consider what damage might be recovered if there were a finding of a tort.”). 63. id. at 346-47. 64. wyatt v. cole (wyatt i), 504 u.s. 158, 168 (1992). 2022] readers of tea-leaves 135 functions would not serve the public good, as it does in regards to public officials.65 that being said, the public good may be served by allowing nonculpable private defendants to assert good-faith as a defense. there is a continuing modern trend towards privatization of government functions.66 as a result, private citizens now perform identical functions to public officials and have even replaced them in some fields.67 for example, some state governments have outsourced the operation of toll roads,68 utilities,69 prisons,70 lotteries,71 student loans,72 airports,73 and other services.74 private citizens performing public functions may serve the public good by providing equal, or even superior service, at a reduced cost. local and state governments hire private citizens to perform government functions because, it least in theory, it is a cost-effective means to fulfill their purpose.75 additionally, governments may privatize services to displace risk, increase revenue, and provide a higher level of service from more experienced providers.76 if successful, the public benefits by receiving the same or higher quality government services at a reduced burden to the taxpayers.77 litigation involving private defendants can, however, raise the cost of privatizing government services, not directly through indemnification, but indirectly by making the jobs less appealing and therefore, more difficult to attract qualified candidates. hedonistic calculus78 65. id. at 167-68. 66. dan weiss, note, privatization and its discontents: the troubling record of privatized prison health care, 86 u. colo. l. rev. 725, 733-34 (2015) (“america’s recent bipartisan infatuation with the privatization of core government services began in the late 1970s and continues to the present day. this privatization revolution has remade the american regulatory landscape.”) (internal quotations omitted). 67. whether the privatization of governmental services is desirable exceeds the scope of this article but is comprehensively addressed in other works. it will suffice to say such privatization is a reality in the modern united states and many support such a trend. it is the position of this article that if and until that course is reversed, the workings of civil law must take this reality into account in order to reach fair and equitable outcomes. 68. commission report, supra note 1, at 9-11. 69. id. at 12-13. 70. id. at 14. 71. id. at 15. 72. id. at 16. 73. id. at 16-17. 74. id. at 17-19. 75. id. at 4. 76. id. at 5-6. 77. id. at 6. 78. also known as “felicific calculus,” hedonistic calculus was theorized by philosopher jeremy bentham in his 1789 book, introduction to the principles of morals and legislation. at its core, hedonistic calculus is a method of calculating the expected benefits and detriments (or pleasure and pain) of any given action. when an act’s detriments are expected to outweigh its benefits, the actor will more likely refrain from completing the act, compared to when the expected 136 indiana health law review [vol. 19:127 predicts that higher risk of personal liability requires a higher salary to justify that risk. just as litigation can distract, discourage, and deter public officials from performing their duties, so too can it distract, discourage, and deter private citizens from performing the same tasks. the good-faith defense can and should provide some measure of protection from liability, not just because it prevents unfair and inequitable outcomes, but because it will serve the public good in those areas where private service providers have replaced public officials as the source of government services. b. the emergence of good-faith as a defense to liability 1. the fifth circuit’s objective good-faith standard the first court to find in favor of the good-faith defense for a private § 1983 defendant was the united states court of appeals for the fifth circuit in wyatt v. cole (wyatt ii).79 in that case, howard wyatt and bill cole, two business partners, had a falling out.80 cole sought and acquired a writ of replevin against wyatt in a mississippi state court.81 the county sheriff executed the writ, seizing “24 heads of cattle, a tractor, and other property from wyatt on july 29 and 30, 1986.” 82 the writ of replevin was not served on wyatt until the following day, july 31, 1986.83 at a post-seizure hearing, a circuit judge dismissed cole’s complaint and ordered him to return the seized property.84 in july of 1987, wyatt filed suit against cole in the u.s. district court for the southern district of mississippi under § 1983 and several state provisions, alleging the seizure without notice violated his right to due process.85 the district court agreed with wyatt and “declared the state replevin statute unconstitutional.”86 despite that, the court found wyatt could not recover damages because cole, a private citizen, was entitled to qualified immunity.87 wyatt eventually appealed his way up to the u.s. supreme court. as discussed previously, the court found private defendants, like cole, could not benefit from qualified immunity because such an extension of the immunity doctrine was not justified by the policies supporting it.88 the court remanded the case to the fifth circuit to determine whether cole was liable under § 1983, and benefits outweigh associated detriments. 79. wyatt v. cole (wyatt ii), 994 f.2d 1113, 1113 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993). 80. id. at 1115, 114 s. ct. at 470. 81. id. 82. id. 83. id. 84. id. 85. id. 86. id. 87. id. 88. wyatt v. cole (wyatt i), 504 u.s. 158, 167-68 (1992). 2022] readers of tea-leaves 137 if so, entitled to “any affirmative defense based on good faith and/or probable cause or that § 1983 suits against private, rather than governmental, parties could require plaintiffs to carry additional burdens.”89 the fifth circuit addressed each issue, in turn.90 first, as cole had used “procedures prescribed by the [state] statute itself,” he had acted under color of state law and was liable under § 1983.91 the court then moved on to the issue of whether cole could affirmatively assert a defense based on good-faith.92,93,94 the defense also required defendant’s reliance on the statute.95 the fifth circuit found that wyatt presented no evidence cole had known the state replevin statute was unconstitutional at the time he invoked it, nor that he had relied unreasonably it.96 consequently, cole was entitled to the good-faith defense against liability.97 surprisingly, since the holding in wyatt, the good-faith defense has seen very little use in the fifth circuit. the second circuit first brushed against the good-faith defense in 1996, in pinsky v. duncan.98 there, the court suggested the existence of the good-faith defense but framed the issue as a failure of the plaintiff to prove a required element of his case.99 a little more than twenty years later, the second circuit would more definitively find for the good-faith defense.100 in jarvis v. cuomo, the court affirmed a district court’s judgment for a private party § 1983 defendant, based on the good-faith affirmative defense.101 there, the court found for the defendant because it was “objectively reasonable for [defendant] to act on the basis of a statute not yet held invalid.”102 based on jarvis, the second circuit adopted the fifth circuit’s objective good-faith standard for the defense. 89. id. at 169. 90. wyatt ii, 994 f.2d at 1117, 114 s. ct. at 470. 91. id. at 1118, 114 s. ct. at 470. 92. id. at 1120 (“[w]e think that private defendants, at least those involving ex parte prejudgment statutes, should not be held liable under § 1983 absent a showing of malice and evidence that they either knew or should have known of the statute’s constitutional infirmity.”), 114 s. ct. at 470. 93. id. 94. id. at 1121, 114 s. ct. at 470. 95. id. 96. id. 97. id. at 1115, 114 s. ct. at 470. 98. see pinsky v. duncan, 79 f.3d 306 (2d cir. 1996). 99. id. at 312-13 (“we think that malicious prosecution is the most closely analogous tort and look to it for the elements that must be established in order for doehr to prevail on his § 1983 damages claim. accordingly, having established that di giovanni’s attachment proceeding ended in failure, it remains for doehr to demonstrate want of probable cause, malice and damages. the burden of proof is, of course, upon the plaintiff.”). 100. jarvis v. cuomo, 660 f. app’x 72, 75 (2d cir. 2016). 101. id. (“[t]he district court did not err in concluding that a good faith defense was available to a private defendant sued under § 1983 for a first amendment violation.”). 102. id. at 76 (quoting pinsky, 79 f.3d at 313) (internal quotes omitted). 138 indiana health law review [vol. 19:127 in 2008, the ninth circuit also adopted the good-faith defense in clement v. city of glendale.103 like the sixth circuit,104 the ninth circuit did not define the contours of the good-faith defense. later, however, the court did affirm a grant of summary judgment in favor of a defendant in a § 1983 suit because the plaintiff failed to show defendant’s conduct was “unreasonable.”105 the ninth circuit good-faith defense requires, at a minimum, a showing of reasonable reliance on a statute. this likely includes a subjective good-faith belief that the statute is valid, because any reliance on a statute is unreasonable if the defendant actually knew it was unconstitutional. this is supported by the circuit’s lower courts’ application of the defense.106 as such, it most closely resembles the fifth circuit’s approach. 2. the third circuit’s subjective good-faith standard the third circuit also found in favor of the existence of good-faith as a defense, in the context of a due process violation with private § 1983 defendants, in jordan v. fox, rothschild, o’brien & frankel.107 the third circuit, however, diverged from the fifth circuit’s objective good-faith approach. in third circuit courts, a private § 1983 defendant is “entitled to a defense of subjective good faith.”108 the third circuit does not require a defendant’s reliance on the law be objectively reasonable, but rather that it is merely subjectively genuine.109 this standard is less demanding, and therefore more frequently successful, as it does not require a defendant to show that reliance on a statute was objectively 103. clement v. city of glendale, 518 f.3d 1090, 1097 (9th cir. 2008) (“having acted on instructions from the glendale police department that specifically called for the tow, [defendant] is entitled to invoke the good faith defense.”). 104. see infra notes 113-14 and accompanying text. 105. weldon v. conlee, 684 f. app’x 612, 612 (9th cir. 2017) (“the district court properly granted summary judgment on weldon’s unlawful seizure claims because weldon failed to raise a genuine dispute of material fact as to whether the impounding of his vehicle was unreasonable.”). 106. see, e.g., gollub v. city of sausalito, no. 18-cv-07386, 2019 u.s. dist. lexis 162259, at *8 (n.d. cal. sept. 17, 2019) (“yet butler may be entitled to a good-faith defense, provided that he was unaware that he was helping the city violate the gollubs’ constitutional rights.”) (emphasis added); allen v. santa clara cnty. corr. peace officers ass’n, 400 f. supp. 3d 998, 1000-1003 (e.d. cal. 2019) (granting a motion to dismiss because defendants “did [their] best [to] follow the law and had no reason to suspect that there would be a constitutional challenge to [their] actions”) (first and third alterations in original) (quoting hernandez v. afscme california, 386 f. supp. 3d 1300, 1304 (e.d. cal. 2019)). 107. jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994) (“[w]e believe private actors are entitled to a defense of subjective good faith.”). 108. id.; see also oliver v. serv. emps. int’l union loc. 668, 415 f. supp. 3d 602 (e.d. pa. 2019). 109. jordan, 20 f.3d at 1277 (“these considerations lead us to conclude ‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more demanding objective standard of reasonable belief that governs qualified immunity.”). 2022] readers of tea-leaves 139 reasonable.110 the third circuit’s subjective good-faith defense has been asserted with greater frequency than other circuits’ objective good-faith standard.111 the sixth circuit followed suit in 1996 when it decided vector research v. howard & howard attorneys p.c.112 the court, however, did not define how the good-faith defense would be applied in that circuit.113 consequently, a district court in ogle adopted, in name, the fifth circuit’s objective good-faith standard.114 the court, however, arguably lessened a defendant’s burden when it found that the “reliance on a statute establishes good faith as a matter of law.”115 in addressing the apparent contradiction of ruling on a defendant’s subjective state of mind as a matter of law, the court favorably cited justice kennedy’s concurring opinion in wyatt: [t]ypically, subjective states of mind are shown through discovery. vector, 76 f.3d at 699 (“any good faith defense must, however, be resolved on remand and not on this rule 12 motion to dismiss.”). see also duncan, 844 f.2d at 1266 (“a good faith defense, on the other hand, is likely to be based in large part on the facts of the case, with the suit only being dismissed after trial, or on summary judgment if the defendant can show that there is no material dispute as to the facts”). however, it is, as a matter of law, reasonable to rely on a presumptively valid statute. wyatt, 504 u.s. 158, 174, 112 s. ct. 1827, 118 l. ed. 2d 504 (1992) (j. kennedy, concurring) (“there is support in the common law for the proposition that a private individual’s reliance on a statute, prior to a 110. diamond v. pa. state educ. ass’n, 399 f. supp. 3d 361, 401 (w.d. penn. 2019) (“by establishing objective reasonableness as a matter of law, union defendants have met the less demanding subjective standard articulated by the third circuit in jordan.”) (emphasis in original). 111. see, e.g., egervary v. young, 366 f.3d 238, 246 (3d cir. 2004) (noting defendants had asserted good-faith as a defense, but resolving the appeal on different grounds); see also, oliver, 415 f. supp. 3d at 602 (holding a defendant was entitled to good-faith as a defense); diamond, 399 f. supp. 3d at 401 (granting summary judgment in favor of defendant on the basis of good-faith defense); foster v. city of phila., no. 12-5851, 2014 u.s. dist. lexis 143107, at *64 (e.d. pa. oct. 8, 2014) (denying summary judgment based on good-faith because there was a material dispute regarding defendant’s subjective state of mind); customers bank v. mun. of norristown, 942 f. supp. 2d 534, 540 (e.d. pa. 2013) (dismissing a complaint for failing to state a claim but noting that defendants might be entitled to a good-faith defense); benn v. universal health sys., no. 99cv-6526, 2001 u.s. dist. lexis 17121, at *21-23 (e.d. pa. july 27, 2001) (noting the defendants were entitled to a good-faith defense); doby v. decrescenzo, no. 94-3991, 1996 u.s. dist. lexis 13175, at *65-66 (e.d. pa. sept. 9, 1996) (granting summary judgment in favor of defendant on the basis of good-faith defense). 112. vector rsch., inc. v. howard & howard att’y p.c., 76 f.3d 692, 699 (6th cir. 1996). 113. ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1086 (s.d. ohio 2019) (“[t]he sixth circuit has not supplied further guidance on the specific contours of the defense.”). 114. id. at 1087. 115. id. at 1091. 140 indiana health law review [vol. 19:127 judicial determination of unconstitutionality, is considered reasonable as a matter of law”). it would be unreasonable to expose [defendant] to discovery when discovery would not change the fact that [defendant] was simply following the existing law.116 this formulation of the good-faith defense has not yet been approved at the circuit court level, but it has not been disapproved either. although this test follows the fifth circuit test in name, it more closely aligns with the third circuit’s subjective good-faith test. under this quasi-objective test, reasonableness is assumed so long as the defendant subjectively relied on the validity of the law.117 the sixth circuit has not seen prevalent use of the goodfaith defense in § 1983 litigation, but one district court, interestingly, opined that a medical healthcare professional in a prison setting would be able to use goodfaith to successfully defend against an eighth amendment deliberate indifference claim.118 3. the seventh circuit approves the good-faith defense in janus v. am. fed’n of state, the seventh circuit held a private § 1983 defendant was entitled to defend “on the ground that it proceeded in good faith.”119 by that point, three standards for the good-faith defense had arguably emerged since the u.s. supreme court remanded wyatt i.120 the seventh circuit quoted both the fifth and third circuits in its janus decision, without appearing to embrace either approach: the [fifth circuit] accordingly held “that private defendants sued on the basis of lugar may be held liable for damages under § 1983 only if they failed to act in good faith in invoking the unconstitutional state procedures, that is, if they either knew or should have known that the statute upon which they relied was unconstitutional.” [wyatt v. cole, 994 f.2d 1113, 1118 (5th cir. 1992), cert. denied, 126 l. ed. 2d 421, 114 s. ct. 470 (1993).] other circuits followed suit. in jordan, the third circuit noted “the [supreme court’s] statement [in wyatt i] that persons asserting section 116. id. at 1092. 117. id. 118. cuco v. fed. med. ctr.-lexington, no. 05-cv-232, 2006 u.s. dist. lexis 49711, at *121 (e.d. ky. june 9, 2006) (“because dr. schneider is not a federal employee, the qualified immunity defense is not available to her, even with respect to work performed for the federal government. she may employ, however, a ‘good faith’ defense.’”). 119. janus v. am. fed’n of state, 942 f.3d 352, 364 (7th cir. 2019). 120. cf. wyatt v. cole (wyatt ii), 994 f.2d 1113, 1115 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993) (objective good-faith); with jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994) (subjective good-faith); and ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1092 (s.d. ohio 2019) (a quasi-objective good-faith test, where reasonableness is assumed). 2022] readers of tea-leaves 141 1983 claims against private parties could be required to carry additional burdens, and the statements in lugar which warn us [that] a too facile extension of section 1983 to private parties could obliterate the fourteenth amendment’s limitation to state actions that deprive a person of constitutional rights and the statutory limitation of section 1983 actions to claims against persons acting under color of law.” 20 f.3d at 1277 (cleaned up). those considerations, the court said, lead to the conclusion that “‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more demanding objective standard of reasonable belief that governs qualified immunity.”121 without explicitly adopting the objective or the subjective approach, the court did offer at least two clues as to its intentions: like our sister circuits, we read the court’s language in wyatt i and lugar, supplemented by justice kennedy’s opinion concurring in wyatt i, as a strong signal that the court intended (when the time was right) to recognize a good-faith defense in section 1983 actions when the defendant reasonably relies on established law.122 by acknowledging the objective reasonableness element, the seventh circuit seemed inclined towards the fifth circuit’s objective good-faith standard.123 the court also, however, paid special note to justice kennedy’s concurrence in wyatt.124 in that concurrence, justice kennedy showed strong support for a subjective good-faith defense by noting that “the existence of a statute thought valid ought to allow a defendant to argue that he acted in subjective good faith and is entitled to exoneration no matter what the objective test is.”125 justice kennedy went on to say that: [t]here is support in the common law for the proposition that a private individual’s reliance on a statute, prior to a judicial determination of unconstitutionality, is considered reasonable as a matter of law; and therefore under the circumstances of this case, lack of probable cause can only be shown through proof of subjective bad faith.126 this is the same text cited by a district court in the sixth circuit when it articulated its quasi-objective good-faith defense standard.127 unfortunately, the court went on to seemingly narrow the defense’s applicability.128 the court noted, 121. janus, 942 f.3d at 363. 122. id. at 366. 123. id. at 365. 124. id. at 366. 125. wyatt v. cole (wyatt i), 504 u.s. 158, 174 (1992) (kennedy, j., concurring). 126. id. (citing birdsall v. smith, 122 n.w. 626 (mich. 1909)). 127. ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1092 n. 15 (s.d. ohio 2019). 128. janus, 942 f.3d at 367 (“[t]he good-faith defense to section 1983 liability is narrow.”). 142 indiana health law review [vol. 19:127 somewhat axiomatically, that not “every defendant that deprives any person of any constitutional right” would be protected by the good-faith defense.129 the seventh circuit unduly limited the scope of the good-faith defense to those private parties who had “relied substantially and in good faith on both a state statute and unambiguous supreme court precedent validating that statute.”130 this formulation is problematic for two reasons. first, it seemingly requires “substantial” reliance.131 the court did not elaborate on what separates substantial reliance from insubstantial or incidental reliance. even if the distinction were clear, the court did not specify why a private party who insubstantially relied on a law was more culpable than a private party who substantially relied on the same law. this peculiarity suggests that two private party defendants who acted identically could face incongruent judgments, based on nothing more than their degree of reliance on a law that was presumptively valid at the time of their actions. the distinction fails to further policy principles of “equality and fairness,” which underlie the good-faith defense.132 it also conflicts with justice kennedy’s concurring opinion in wyatt i, which the seventh circuit favorably cited as a source informing its decision to adopt the good-faith defense.133 further, the seventh circuit seemed to imply the defense would only protect a private party defendant from liability if the u.s. supreme court had unambiguously validated the statute.134 this turns justice kennedy’s point on its head. in wyatt i, justice kennedy voiced support for the proposition that reliance on a law was presumptively valid “prior to a judicial determination of unconstitutionality.”135 the seventh circuit inverted that principle, and now possibly requires judicial approval of a law, from the highest court in the land no less, before reliance on that law is considered reasonable.136 this standard, perplexingly, requires private parties to maintain a higher degree of legal awareness than their public official counterpart. a public official will benefit from qualified immunity so long as their conduct did not violate a “clearly 129. id. 130. id. (emphasis in original). 131. id. at 365. 132. wyatt v. cole (wyatt i), 504 u.s. 158, 168 (1992). 133. cf. janus, 942 f.3d at 367 (holding for the good-faith defense of a party that “relied substantially and in good faith on both a state statute and unambiguous supreme court precedent validating that statute”) with wyatt i, 504 u.s. at 174 (kennedy, j., concurring) (noting there is support in common for the proposition that reliance on any statute, prior to its judicial invalidation, is reasonable as a matter of law) and janus, 942 f.3d at 366 (“[w]e read the court’s language in wyatt i and lugar, supplemented by justice kennedy’s opinion concurring in wyatt i, as a strong signal that the court intended (when the time was right) to recognize a good-faith defense in section 1983 actions when the defendant reasonably relies on established law.”). 134. janus, 942 f.3d at 364. 135. wyatt i, 504 u.s. at 174 (kennedy, j., concurring). 136. janus, 942 f.3d at 367. 2022] readers of tea-leaves 143 established” law, regardless of his subjective awareness137 but a private party defendant in the seventh circuit cannot rely on a law until it has been validated by the u.s. supreme court.138 this confusing dichotomy runs counter to the court’s opinion earlier in janus, when it noted that “[t]he rule of law requires that parties abide by, and be able to rely on, what the law is, rather than what the readers of tea-leaves predict that it might be in the future.”139 by the end of the janus decision, it was left unclear whether private parties are able to rely on a presumptively valid statute, or instead must wait until the u.s. supreme court affirmatively validates it.140 iii. effectiveness of the good-faith defense based on policy concerns at present, six u.s. courts of appeals have explicitly found for the existence of the good-faith defense for private party § 1983 defendants.141 the fifth circuit was the first court of appeals to approve its use in 1993.142 the seventh circuit is the most recent court to adopt it in 2019.143 consequently, the seventh circuit stands to profit from the lessons learned in other circuits. the effectiveness of the good-faith defense can only be measured in light of the policy concerns the defense is intended to address. notably, the defense serves “principles of equality and fairness” by protecting private defendants who relied on a valid law from § 1983 liability.144 when used appropriately, this results in “equal” and “fair” treatment of private § 1983 defendants when compared to public officials susceptible to § 1983 suits for identical conduct. a. which approach best serves the policies underlying the good-faith defense it is a tenet of american law that severity of punishment is tied to degree of criminal or civil culpability.145 by logical extension, equal culpability will lead to equal liability. all things being equal, if two defendants, one private party and one public official, engaged in identical conduct without malice, their culpability 137. harlow v. fitzgerald, 457 u.s. 800, 818 (1982). 138. janus, 942 f.3d at 367. 139. id. at 366 (emphasis in original). 140. id. at 367. 141. see wyatt v. cole (wyatt ii), 994 f.2d 1113, 1118 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993); jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994); vector rsch., inc. v. howard & howard att’y p.c., 76 f.3d 692, 699 (6th cir. 1996); clement v. city of glendale, 518 f.3d 1090, 1096-97 (9th cir. 2008); jarvis v. cuomo, 660 fed. appx. 72, 75 (2d cir. 2016); and janus, 942 f.3d at 364. 142. wyatt ii, 994 f.2d at 1121, 114 s. ct. at 470. 143. janus, 942 f.3d at 364. 144. wyatt v. cole (wyatt i), 504 u.s. 158, 168 (1992). 145. atkins v. virginia, 536 u.s. 304, 319 (2002) (“[t]he severity of the appropriate punishment necessarily depends on the culpability of the offender.”). 144 indiana health law review [vol. 19:127 levels would be the same. the public official defendant could avoid the suit by successfully claiming qualified immunity, if he or she did not violate clearly established law, under harlow.146 on the other hand, the private party defendant could defend against liability by presenting the affirmative good-faith defense. the private party § 1983 defendant’s defense would take a different form, but ultimately lead to the same favorable outcome as the public official. in light of their respective degrees of culpability, this would be an equitable outcome. the defense also intends to serve the principle of fairness.147 ideally, it does so by holding private § 1983 defendants not liable for acts they committed in reliance on a valid-at-the-time statute. this is fair because private parties are not “readers of tea-leaves” who might predict what laws will be upheld or struck down in the future148 the difference between the objective and the subjective good-faith standards is best examined in light of the differing views on how best to serve the principle of fairness. under the objective view, fairness is best served only if a private party § 1983 defendant reasonably relies on a law.149 in other words, it would be unfair to a plaintiff with a meritorious claim to allow a defendant to avoid liability based on unreasonable reliance. this view is not without merit but fails to account for the obvious question: when is reliance on a valid law’s validity ever unreasonable? it is presumably unreasonable to rely on a law that flagrantly and obviously contravened the u.s. constitution, but such laws are hardly abundant. as a practical matter, for reliance to be unreasonable, the law upon which the defendant relied would have to have been so obviously unconstitutional that even a layperson without legal training would recognize it as such. under the subjective good-faith standard, on the other hand, fairness is served by protecting defendants who actually relied on a valid law.150 fairness is served in this regard by preventing liability from attaching to the ignorant, but not malicious, defendant who violated another’s federal rights in reliance on a law that was later invalidated.151 the subjective approach more congruently serves fairness because it would be unfair to expect laypersons to predict the constitutionality of the very laws they must rely on to perform their myriad of 146. harlow v. fitzgerald, 457 u.s. 800, 818 (1982). 147. wyatt i, 504 u.s. at 168. 148. janus, 942 f.3d at 366 (emphasis in original); accord ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1091 (s.d. ohio 2019) (“in short, it is patently unfair to expect private actors to be able to predict the future of constitutional law.”). 149. see, e.g., wyatt v. cole (wyatt ii), 994 f.2d 1113, 1121 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993). 150. see, e.g., jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994) (“these considerations lead us to conclude ‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more demanding objective standard of reasonable belief that governs qualified immunity.”). 151. see, e.g., ogle, 397 f. supp. 3d at 1091 (“in short, it is patently unfair to expect private actors to be able to predict the future of constitutional law.”). 2022] readers of tea-leaves 145 professional tasks.152 both approaches serve equality by preventing disparate outcomes for similarly culpable § 1983 defendants, but the subjective approach better addresses the principle of fairness. consequently, the subjective good-faith standard is the better approach. further, equality and fairness are best served if the defense is liberally applied. defendants should assert the good-faith defense in every case where it might apply, and courts should assess those assertions in light of the principles of fairness and equality. without liberal application of the good-faith defense, liability will continue to turn merely on the defendant’s employer (a private company or government agency). a public official can claim qualified immunity and defeat not only liability but avoid trial altogether, while the private § 1983 defendant is left mired in litigation and potential liability. equality militates towards an early determination of whether the good-faith defense precludes liability, while fairness requires that a court seriously consider the availability and appropriateness of the good-faith defense in every § 1983 suit in which it is asserted. b. suggestions on successful implementation the subjective good-faith standard is more in line with the policies supporting the defense, and therefore, superior. the fifth, second, and ninth circuits all presently utilize an objective standard.153 without adopting the subjective standard, these circuits can allow more effective use of the good-faith defense by finding that reliance on a valid law is presumptively reasonable as a matter of law, as the district court in ogle did.154 as a presumption, it would weigh in favor of a private § 1983 defendant, but not unreasonably so. a plaintiff could overcome the presumption by offering evidence that a defendant’s reliance on the law in question was unreasonable. this approach would preserve the objective element of the good-faith defense while also acknowledging the extreme rarity of unreasonable reliance on a valid law. in every circuit where the good-faith defense is recognized, district courts should consider the defense early in litigation. as an issue of fact, some courts might wish to err on the side of caution by allowing a jury to decide the issue. the court in ogle contemplated this approach, but ultimately rejected it.155 once asserted by a private § 1983 defendant, a plaintiff must overcome that defense by showing the defendant did not subjectively rely on a valid law, or that reliance was unreasonable (in circuits employing the objective good-faith standard). there are situations, especially in subjective good-faith jurisdictions, where no amount of discovery could defeat reliance on a valid law as a good-faith defense. in situations where discovery cannot bear on the issue, and defendant is entitled to 152. see janus, 942 f.3d at 366. 153. see wyatt ii, 994 f.2d at 1121, 114 s. ct. at 470; clement v. city of glendale, 518 f.3d 1090, 1097 (9th cir. 2008); jarvis v. cuomo, 660 f. app’x 72 (2d cir. 2016). 154. ogle, 397 f. supp. 3d at 1091. 155. id. at 1092. 146 indiana health law review [vol. 19:127 judgment as a matter of law based on good-faith reliance on a valid law, a court should spare the parties the needless and wasteful expense of discovery by dismissing the case. this would most likely take the form of a defendant’s motion to dismiss under federal rule 12(c).156 a defendant should assert the affirmative defense of good-faith in his or her answer, and then file the 12(c) motion to dismiss with the court. if at that point, based on the pleadings and taking all facts alleged by the plaintiff as true, the defendant is entitled to the good-faith defense as a matter of law, the case should be dismissed. if, however, the good-faith defense’s applicability remains unclear, the court must allow the case to move forward to discovery. following discovery, a defendant may again move to dismiss the case by filing a motion for summary judgment.157 at that point, the court should consider whether plaintiff has collected any evidence, regardless of credibility, that would allow a reasonable jury to find the defendant is not entitled to the good-faith defense. if plaintiff cannot produce such evidence, the court should grant the motion for summary judgment in favor of the defendant who is entitled to the good-faith defense.158 if a genuine dispute of material fact regarding whether defendant relied in good-faith on the law, then the issue should be left for the jury to decide. c. the practical implications of efficient implementation of the good-faith defense by considering the good-faith defense early and applying it liberally, courts will better serve the policies informing its utility – equality and fairness.159 equality is served by allowing a nonculpable private § 1983 defendant to avoid a trial, similar to how an identically-situated public official will avoid trial by asserting qualified immunity. fairness is served by allowing nonculpable defendants to not only defeat liability, but to avoid the long and arduous process of trial. whether the good-faith defense applies is a matter of fact, not law, but that does not prevent courts from potentially deciding it early, as the court in ogle did.160 a meritorious plaintiff, however, can defeat the good-faith defense by producing evidence that the defendant did not objectively or subjectively, depending on jurisdiction, rely in good-faith on a valid law at the summary judgment stage. this strikes the proper balance between preserving judicial economy and serving the policies underlying the good-faith defense, while also 156. fed. r. civ. p. 12(c) (“after the pleadings are closed—but early enough not to delay trial—a party may move for judgment on the pleadings.”). 157. fed. r. civ. p. 56(a) (“a party may move for summary judgment, identifying each claim or defense—or the part of each claim or defense—on which summary judgment is sought.”). 158. id. (“the court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”). 159. wyatt v. cole (wyatt i), 504 u.s. 158, 168 (1992). 160. ogle, 397 f. supp. 3d at 1092. 2022] readers of tea-leaves 147 permitting meritorious plaintiffs to vindicate their federal rights. without the good-faith defense, the distinction between public officials and private citizens produces inequitable outcomes. as qualified immunity is available only to public officials, liability for a constitutional tort may turn on employer status. as such, two equally culpable defendants can be subjected to two divergent verdicts. the public official will be immune to suit, while the private citizen is liable for compensatory and possibly punitive damages. this discrepancy is further exacerbated in light of the practical reality of how liability, if eventually assessed, impacts the two distinct classes of defendants. private citizens may be insured in case of liability, but such insurance rarely covers punitive damages.161 conversely, many states indemnify public employees for all damages, in addition to funding legal expenses and attorney’s fees.162 the federal rules of evidence generally preclude consideration of indemnification or liability insurance as evidence of liability,163 but that does not stop some courts from considering them in light of which party might be better positioned to finance the cost of litigation. for example, the famous jurist judge posner of the seventh circuit once opined in dicta that defendants of § 1983 suits were better-positioned to cover the costs of expert witnesses because their defenses were generally financed through liability insurance or indemnification agreements.164 even disregarding the benefits of qualified immunity, public officials still have an advantage over private defendants because indemnification agreements between state employers and their employers are often more comprehensive than the liability insurance of their private citizen counterpart. proper use of the good-faith defense helps to ameliorate these inequitable circumstances by permitting the private defendant to affirmatively defend against liability. section 1983 plaintiffs will argue against the early and liberal use of the good-faith defense as a means to efficiently adjudicate some cases. plaintiffs with 161. alan i. widiss, liability insurance coverage for punitive damages? discerning answers to the conundrum created by disputes involving conflicting public policies, pragmatic considerations and political actions, 39 vill. l. rev. 455, 460 n.11 (1994) (“when courts award punitive damages as the result of a tortious act, liability insurance coverage may be unavailable because: (1) there are terms in the applicable insurance policy setting forth an exclusion for punitive damages; (2) legislative provisions prohibit such coverage; or (3) such coverage violates state public policy established by judicial decision.”). 162. see, e.g., 5 ill. comp. stat. 350/2(d) (2017) (“[t]he state shall indemnify the state employee for any damages awarded and court costs and attorneys’ fees assessed as part of any final and unreversed judgment, or shall pay such judgment.”). 163. fed. r. evid. 411 (“evidence that a person was or was not insured against liability is not admissible to prove whether the person acted negligently or otherwise wrongfully.”). 164. rowe v. gibson, 798 f.3d 622, 634 (7th cir. 2015) (“in addition, an expert’s fee, if any, would in a case such as this, with its numerous defendants, be split many ways or, more likely, be paid for by the indiana department of correction, the state of indiana, corizon or its liability insurer, or individual defendants’ malpractice insurance (depending on the contractual arrangements between corizon and the state, as well as the parties’ insurance arrangements), or some combination of these well-heeled entities.”). 148 indiana health law review [vol. 19:127 seemingly meritorious claims should not be denied access to a jury, but rather allowed to present their evidence and argument to a jury to decide the issues of fact. this is an inherently appealing argument, but ultimately counter-intuitive. the good-faith defense, especially in subjective jurisdictions, will simply defeat all claims of constitutional violations as a matter of law. in circuits that recognize the good-faith defense, this is an unavoidable possibility. allowing a plaintiff to move forward through a trial against a private § 1983 defendant entitled to the good-faith defense, merely to allow a jury to conclude the defense applies, does an injustice to that defendant by needlessly forcing him or her to bear the costs of discovery and litigation. this also burdens the judicial system by futilely trying cases where plaintiffs, as a matter of law, cannot prevail. in an overtaxed judicial system plagued by extended delays and substantial expense, wise use and adjudication of the good-faith defense will help diminish backlogged cases, prevent delay, and reduce costs to the parties. iv. recommendations on practical application in the seventh circuit a. seventh circuit courts should liberally apply the good-faith defense the seventh circuit’s language in janus seemingly precluded liberal application of the good-faith defense by restricting its applicability to defendants who substantially relied on a valid law which had been affirmatively and unambiguously approved by the u.s. supreme court.165 that, however, may not necessarily be true. the seventh circuit, in keeping with the judicial requirement of deciding only live cases or controversies,166 ruled on the case before it. in janus, the private party defendant had substantially relied on a valid-at-the-time law, which had been unambiguously validated by the u.s. supreme court.167 the janus court was asked whether a defendant, under those conditions, was entitled to the good-faith defense,168 and it based its decision on the narrow set of facts. 165. janus v. am. fed’n of state, 942 f.3d 352, 367 (7th cir. 2019) (“we predict that only rarely will a party successfully claim to have relied substantially and in good faith on both a state statute and unambiguous supreme court precedent validating that statute.”). 166. u.s. const. art. iii, § 2, cl. 1 (“the judicial power shall extend to all cases, in law and equity, arising under this constitution, the laws of the united states, and treaties made, or which shall be made, under their authority;—to all cases affecting ambassadors, other public ministers and consuls;—to all cases of admiralty and maritime jurisdiction;—to controversies to which the united states shall be a party;—to controversies between two or more states;—between a state and citizens of another state;—between citizens of different states;—between citizens of the same state claiming lands under grants of different states, and between a state, or the citizens thereof, and foreign states, citizens or subjects.”). 167. janus, 942 f.3d at 356-57. 168. id. at 362 (“we must decide whether a union may raise any such defense against its liability for the fair-share fees it collected before [janus v. afscme, council 31, 138 s. ct. 2448, 2461 (2018)].”). 2022] readers of tea-leaves 149 it did not decide whether a private § 1983 defendant could claim good faith as a defense when he or she had relied on a law that had not been affirmatively and unambiguously validated by the u.s. supreme court because that was not at issue in the case. in fact, the seventh circuit arguably could not have decided that without issuing an advisory opinion.169 as such, courts in the seventh circuit may rightfully consider that the class of defendants who may claim good faith as an affirmative defense has not been conclusively defined. the janus court did note, however, that “the good-faith defense to section 1983 liability is narrow.”170 this explicitly limits applicability of the good-faith defense but does not define its boundaries. seventh circuit courts should still recognize that private party § 1983 defendants who relied on a valid-at-the-time law are entitled to the good-faith defense. this finding is not precluded by the court’s ruling in janus and well in keeping with the policy principle of fairness. as a follow up to janus, the seventh circuit might consider clarifying its holding in that case by more specifically and broadly defining the defense’s applicability. as previously addressed, broad applicability of the good-faith defense is advantageous in light of the policy principles of equality and fairness.171 the good-faith defense serves several policy principles,172 but those principles may only be satisfied if the defense is feasible for worthy defendants. at present, the principal obstacle standing in the way of the defense’s effective use is the seventh circuit’s own use of unnecessarily constrictive language when it adopted the good-faith defense.173 seventh circuit district courts should interpret the janus court as ruling only on the facts before it without expressly precluding the good-faith defense from other private § 1983 defendants. the seventh circuit itself should clarify its position by addressing the broader applicability of the good-faith defense as soon as an opportunity presents itself. b. the good-faith affirmative defense as a practical means to efficiently resolve cases under the federal rules of civil procedure, an affirmative defense must be asserted in response to a plaintiff’s complaint.174 rule 8 allows a party to plead in the alternative, so a defendant may, in her answer, deny performing the 169. see, e.g., united pub. workers v. mitchell, 330 u.s. 75, 89 (1947) (“as is well known, the federal courts established pursuant to article iii of the constitution do not render advisory opinions. for adjudication of constitutional issues, ‘concrete legal issues, presented in actual cases, not abstractions,’ are requisite.”). 170. janus, 942 f.3d at 367. 171. see supra notes 144-56 and accompanying text. 172. see supra notes 43-71 and accompanying text. 173. see janus, 942 f.3d at 367 (“we predict that only rarely will a party successfully claim to have relied substantially and in good faith on both a state statute and unambiguous supreme court precedent validating that statute.”); see also supra notes 122-31 and accompanying text. 174. fed. r. civ. p. 8(c) (“in responding to a pleading, a party must affirmatively state any avoidance or affirmative defense.”). 150 indiana health law review [vol. 19:127 allegedly tortious conduct or omission, deny that the conduct amounted to a constitutional violation, and, in the alternative, plead the affirmative defense of good-faith.175 whether this is a wise strategy will depend on the facts of the case, the court hearing the case, and, ultimately, the judgment, acumen, and competency of the defense attorney presenting those arguments. defendants must always be mindful of how an affirmative defense, as a concept, operates. an affirmative defense is the “defendant’s assertion of facts and arguments that, if true, will defeat the plaintiff’s or prosecution’s claim, even if all the allegations in the complaint are true.”176 a defendant cannot merely invoke the magic words “good faith” and expect a quick dismissal. to successfully plead the good-faith defense, private § 1983 defendants must raise a series of facts that, if true, defeat plaintiff’s claim.177 the first such fact is the existence of a then-valid law.178 the law, either state or federal, had to be in effect at the time the defendant allegedly violated plaintiff’s rights. further, defendant must establish a connection between the law and the alleged violation, namely that the law upon which defendant relied authorized the conduct or omission that plaintiff alleges deprived him or her of a federal right. second, a defendant must show that she “proceeded in good faith.”179 the seventh circuit did not explicitly define how good-faith reliance was to be pled or demonstrated. as a practical matter, a defendant should plead that her course of conduct was guided by the law at the time without a malicious intent to deprive plaintiff of a constitutional right. if defendant did maliciously intend to deprive plaintiff of a constitutional right, then a law permitting such conduct might not excuse the defendant’s liability.180 this subjective intent is a factually sensitive issue, which may preclude dismissal even after discovery.181 the seventh circuit went on to note that the defendant in janus was entitled to the good-faith defense 175. fed. r. civ. p. 8(d)(2) (“a party may set out two or more statements of a claim or defense alternatively or hypothetically, either in a single count or defense or in separate ones. if a party makes alternative statements, the pleading is sufficient if any one of them is sufficient.”). 176. defense, black’s law dictionary (10th ed. 2014). 177. id. 178. janus, 942 f.3d at 366 (finding the existence of a valid-at-the-time law “when [illinois] adopted a labor relations scheme providing for exclusive representation of public-sector workers and the remit of fair-share fees to the recognized union”). 179. id. at 363-64 (“we now join our sister circuits in recognizing that, under appropriate circumstances, a private party that acts under color of law for purposes of section 1983 may defend on the ground that it proceeded in good faith.”). 180. this apparent conflict between good-faith reliance on a valid law and malicious intent to deprive a plaintiff of a constitutional right is not well settled and this article takes no opinion on the preferred outcome. it will suffice to say, however, that defendants who maliciously, but legally (at the time) deprived a plaintiff of a constitutional right may not be able to escape liability through the good-faith defense. 181. fed. r. civ. p. 56(a) (“the court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”). 2022] readers of tea-leaves 151 because it “relied substantially and in good faith on both a state statute and unambiguous supreme court precedent validating that statute.”182 as previously discussed, this language is problematic in what it suggests.183 if the seventh circuit truly intended to limit the good-faith defense’s applicability only to those defendants who had substantially relied on a statute that had been unambiguously validated by the u.s. supreme court,184 then the defense is reduced to a paper tiger.185 no other circuit defined the defense so narrowly.186 in keeping with the opinions favorably cited by the seventh circuit in the janus opinion,187 a defendant should be successful if she can show she relied in good faith on a law valid at the time of the alleged violation. in sum, to be successful, a defendant must plead that (1) a valid law authorized defendant’s conduct which plaintiff claims deprived him or her of a federal right, and (2) the defendant relied on that law in good faith. defendant must support these assertions with facts, which if true, “will defeat the plaintiff’s […] even if all the allegations in the complaint are true.”188 whether that can be established as a matter of law at the pleading stage, as the ogle court held,189 must be determined by the district courts within the seventh circuit. on the other hand, to defeat the good-faith affirmative defense at the summary judgment stage, a plaintiff must produce facts sufficient for a reasonable jury to infer that either there was no valid law which authorized defendant’s conduct, or defendant did not rely on that law in good faith. c. states can encourage the robust use of the good-faith defense through legislation another roadblock to the defense’s effective implementation is a lack of laws regulating areas where private parties perform public functions. after all, a defendant claiming the good-faith defense needs to be able to affirmatively assert 182. janus, 942 f.3d at 335. 183. see supra notes 129-41 and accompanying text. 184. see supra notes 166-70 and accompanying text. 185. merriam-webster defines a paper tiger as “one that is outwardly powerful or dangerous but inwardly weak or ineffectual.” paper tiger, merriam-webster, https://merriam-webster.com/ dictionary/paper%20tiger [https://perma.cc/9rgn-bj9q] (last visited dec. 3, 2019). 186. see generally, wyatt v. cole (wyatt ii), 994 f.2d 1113, 1118 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993); jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994); vector rsch., inc. v. howard & howard att’y p.c., 76 f.3d 692, 699 (6th cir. 1996); clement v. city of glendale, 518 f.3d 1090, 1096-97 (9th cir. 2008); and jarvis v. cuomo, 660 fed. appx. 72 (2d cir. 2016). 187. janus, 942 f.3d at 363-64 (favorably citing the fifth and third circuits’ decisions adopting the defense, as well as justice kennedy’s concurring opinion in wyatt). 188. defense, black’s law dictionary (10th ed. 2014). 189. ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1092 (s.d. ohio 2019) (“[i]t would be unreasonable to expose [defendant] to discovery when discovery would not change the fact that [defendant] was simply following the existing law.”). 152 indiana health law review [vol. 19:127 the existence of a law. by way of example, under the eighth amendment, prisoners are entitled to adequate medical treatment during their incarceration.190 doctors and nurses who provide healthcare to state prisoners, however, are principally guided by administrative codes, operating procedures, and their own medical training – not statutory schemes defining what treatment is “adequate.”191 while it is important to allow healthcare providers the discretion to treat patients flexibly as situations develop and change,192 a statutory set of guidelines would provide a framework defining, at least, a minimal level of care necessary to comply with the law. the area of prisoner healthcare is a superlative area for legislation because “[t]he federal bureau of justice statistics reports that prisoners enter prison with higher rates of health problems than others – higher rates of chronic diseases, more extensive histories of infectious disease”193 and prison litigation remains prevalent despite the prison litigation reform act (“plra”).194 the convergence 190. see estelle v. gamble, 429 u.s. 97, 104 (1976) (concluding “deliberate indifference” to a prisoner’s serious medical needs constitutes a violation of the eighth amendment). 191. cf. holger sonntag, comment, medicine behind bars: regulating and litigating prison healthcare under state law forty years after estelle v. gamble, 68 case w. rsrv. l. rev. 603, 608-09 (2019) (“some statutes formulate basic requirements for prison healthcare--such as an initial physical and mental examination for all new inmates, or that inmates are required to contribute to healthcare expenditures through co-payments --but then delegate the authority to prescribe more detailed standards for healthcare to the state’s department of corrections. other statutes simply delegate all such decisions to the state agency responsible for running state prisons while setting very general or no parameters.”); and jeffrey natterman & pamela rayne, the prisoner in a private hospital setting: what providers should know, 19 j. health care l. & pol’y 119, 119 (2017) (medical providers in a prison setting are expected to “follow ethical clinical practice guidelines established by national medical societies, and base their practices on well-established, evidenced-based metrics.”). see also, damon martin, comment, state prisoners’ rights to medical treatment: merely elusive or wholly illusory, 8 nat’l black l.j., 427, 435-36 (1983) (“[t]here are relatively few statutes that require treatment of particular inmate illnesses. the few statutes that directly pertain to prisoner medical treatment are so ambiguous that they provide little practical guidance determining seriousness [of injury or illness].”); marvin zalman, prisoners’ rights to medical care, 63 j. crim. l., criminology & police sci. 185, 187 (1972) (“absent a statute, states rely on correctional administrators and medical officers to supply the complex of goods and services which amounts to adequate medical care.”). 192. jörg pont et al., prison health care governance: guaranteeing clinical independence, 108 am. j. pub. health 472, 474 (2018) (“unrestricted clinical independence for health care providers constitutes the bedrock of ethically sound health care for individuals in detention, and is based on the assertion that the sole task of health care professionals is to evaluate, protect, or improve their patients’ physical and mental health.”). 193. camille bennett, repairing the health care system for prisoners in illinois, am. civ. liberties union illinois (jan. 10, 2018, 6:00 pm), https://www.aclu-il.org/en/news/repairinghealth-care-system-prisoners-illinois [https://perma.cc/85zw-glab]. 194. margo schlanger, trends in prisoner litigation, as the plra enters adulthood, 5 u.c. irvine l. rev. 153, 156-57 (2015) (“since 2007, filing rates, prison population, and filings have 2022] readers of tea-leaves 153 of generally increased medical necessity, a litigious population, and a lack of protection by qualified immunity places prisoners’ private party healthcare providers in an especially precarious position. factoring in the significant incarceration rates in the united states along with the increased healthcare demands of prisoners makes the lack of a statutory scheme especially harmful for the prisoners themselves.195 statutory guidance would help alleviate these concerns and offer a feasible means to defend against liability through the goodfaith defense. that is not to say that prisoner healthcare is entirely unregulated. virtually every state regulates prisoner healthcare to some degree.196 illinois, for example, has codified a few mandates in regards to prisoner healthcare in its compiled statutes.197 illinois guarantees prisoners “confidential testing for infection with human immunodeficiency virus (hiv)” and “medical care while incarcerated, counseling, and referrals to support services” if positive for hiv.198 the statute goes on to permit a chief administrative officer to consent to treatment on a prisoner’s behalf in certain life-threatening situations, if that prisoner is unable to consent.199 post janus, a private party employed as a chief administrative officer who gives consent to surgical treatment on behalf of a prisoner facing a life-threatening situation but is unable to consent, in good-faith reliance on the illinois statute, can claim the good-faith defense if that prisoner later alleges a constitutional violation based on that action. this scenario, however, is limited to an extraordinarily narrow set of circumstances because the law relied on applies only to a relatively uncommon situation. by more comprehensively codifying prisoner healthcare requirements and permissible treatment methods, states can broaden the applicability of the good-faith defense. states should more comprehensively regulate the area of prisoner healthcare by codifying how medical treatment is to be performed. this would provide private party medical service personnel guidance in how treatment is to be applied, offer a fair defense to liability when applicable, and create uniform procedures in how all state prisoners are to be treated. laws such as these might be a boon to plaintiffs with meritorious claims, as well. a defendant whose conduct violated clear statutory authority could not claim the good-faith defense, and the plaintiff may even be able to offer that violation as evidence of defendant’s negligence or malicious intent. in addition to prisoner healthcare, states can benefit from comprehensively regulating numerous areas where private parties perform public functions.200 all plateaued.”). 195. see amy vanheuverzwyn, note, the law and economics of prison health care: legal standards and financial burdens, 13 u. pa. j.l. & soc. change 119, 120 (2010) (“the combination of the health care crisis and the incarceration crisis can be deadly.”). 196. sonntag, supra at 191. 197. see 730 ill. comp. stat. 5/3-6-2 (2019). 198. id. at 5/3-6-2(d-5). 199. id. at 5/3-6-2(e). 200. see supra notes 69-75 and accompanying text (discussion on traditionally public 154 indiana health law review [vol. 19:127 v. conclusion there is a reason why “every federal appellate court to have decided the question has held” for the existence of the good-faith defense to liability.201 the good-faith defense simply makes good sense. it is intuitively appealing because it serves universally-regarded principles of “equality and fairness,” without allowing culpable defendants to escape consequences.202 before the good-faith defense, liability in many § 1983 cases turned on the character of the defendant’s employer.203 employment status, private or public, is a truly spurious means by which to determine liability and apportion blame. the good-faith defense somewhat corrects that inequity by providing nonculpable private § 1983 defendants a means to defeat liability. after all, private citizens are no more effective “readers of tea-leaves”204 than public officials when it comes to predicting the future constitutionality of present-day law. the fifth circuit has adopted an objective good-faith defense that requires a defendant show actual and reasonable reliance on a law.205 the third circuit, in contrast, has formulated a subjective good-faith defense where a private defendant need only show actual reliance on the law as a means to defend against § 1983 liability.206 the sixth circuit has not definitively ruled on whether a defendant must objectively or subjectively show good-faith to benefit from the defense, but a sixth circuit district court has concluded that reliance on the law is reasonable as a matter of law.207 in considering the principles that the defense serves, the subjective good-faith standard is superior. the subjective good-faith standard protects genuinely nonculpable private § 1983 defendants without requiring a showing of reasonable reliance.208 with that in mind, in circuits where reasonableness remains an functions being increasingly performed by private citizens). 201. janus v. am. fed’n of state, 942 f.3d 352, 361-62 (7th cir. 2019). 202. wyatt v. cole (wyatt i), 504 u.s. 158, 168 (1992). 203. id. at 168-69 (holding qualified immunity was available to public officials but not private citizens performing identical functions). 204. janus, 942 f.3d at 366 (“the rule of law requires that parties abide by, and be able to rely on, what the law is, rather than what the readers of tea-leaves predict that it might be in the future.”) (emphasis in original). 205. wyatt v. cole (wyatt ii), 994 f.2d 1113, 1120 (5th cir. 1993), cert. denied, 114 s. ct. 470 (1993). 206. jordan v. fox, rothschild, o’brien & frankel, 20 f.3d 1250, 1277 (3rd cir. 1994) (“these considerations lead us to conclude ‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more demanding objective standard of reasonable belief that governs qualified immunity.”). 207. ogle v. ohio civ. serv. emp. ass’n, afscme, local 11, 397 f. supp. 3d 1076, 1092 (s.d. ohio 2019). 208. jordan, 20 f.3d at 1277 (“these considerations lead us to conclude ‘good faith’ gives state actors a defense that depends on their subjective state of mind, rather than the more 2022] readers of tea-leaves 155 element of the good-faith defense, the ogle court’s approach to objective reasonableness is extremely appealing.209 in objective good-faith circuits, district courts should consider the line of reasoning proposed by justice kennedy in his concurring opinion in wyatt210 and given effect by the ogle court.211 namely, that reliance on a valid statute is presumptively reasonable as a matter of law. the defense, whether objective or subjective, would most effectively satisfy its underlying policy principles if given meaningful consideration in the earliest stages of § 1983 proceedings. if possible, a court should make a determination of its applicability before the discovery stage of litigation, in order to spare parties the costly expense of discovery. if there remains a genuine factual dispute as to good-faith reliance, the court should allow discovery but revisit the issue prior to trial. defendants should assert the good-faith defense at each available opportunity. states can support the use of the good-faith defense by private § 1983 defendants by legislating those areas where private citizens have prominently begun to replace public officials in providing government services. this will help reduce inconsistent qualities of service between disparate state institutions while providing private party § 1983 defendants a genuine opportunity to plead the good-faith defense. the seventh circuit, despite its problematic language in janus,212 is in a position to develop a robust, rational, and meaningful good-faith defense to satisfy the interests of equality and fairness while positively affecting judicial economy. private party § 1983 defendants cannot benefit from qualified immunity and are subject to a differing standard of liability. the good-faith defense can help alleviate that gross imbalance. ultimately, the good-faith defense is not a means for culpable parties to escape liability – it is a method by which nonculpable parties are efficiently vindicated. those are laudable goals and seventh circuit courts are now well-positioned to embrace an operative goodfaith defense as a means to achieve them. demanding objective standard of reasonable belief that governs qualified immunity.”). 209. ogle, 397 f. supp. 3d at 1092. 210. wyatt v. cole (wyatt i), 504 u.s. 158, 174 (1992) (kennedy, j., concurring) (“[t]here is support in the common law for the proposition that a private individual’s reliance on a statute, prior to a judicial determination of unconstitutionality, is considered reasonable as a matter of law . . . .”). 211. ogle, 397 f. supp. 3d at 1092. 212. janus v. am. fed’n of state, 942 f.3d 352, 367 (7th cir. 2019) (“before closing, we emphasize again that the good-faith defense to section 1983 liability is narrow. it is not true, as mr. janus charges, that this defense will be available to ‘every defendant that deprives any person of any constitutional right.’ we predict that only rarely will a party successfully claim to have relied substantially and in good faith on both a state statute and unambiguous supreme court precedent validating that statute.”) (emphasis in original). breaking barriers to birth control: why access to birth control matters and what still needs to be done breaking barriers to birth control: why access to birth control matters and what still needs to be done shae overton * i. introduction a. the issue: consistent access to medication is important for ensuring women’s health in 2023, the indiana legislature passed a statute, indiana code § 25-26-25, which gives pharmacists the ability to prescribe contraceptives. indiana is far from the first state to pass such legislation, but there are still questions about what would be the best way to maximize the statute’s effectiveness. this note begins with an introductory, fictitious story showing how contraceptive access is vital for a variety of reasons, not just birth control. it will then provide background information about the statute, the history of the right to birth control, and how other states have implemented similar statutes that allow pharmacists to prescribe contraceptives. next, this note will provide an analysis of how indiana should implement the statute to ensure that it does increase access to contraceptives by addressing why pharmacists need proper incentives to provide additional services. the note will then discuss how to increase legislative awareness to inform women of the new services that pharmacists can provide and how pharmacists will be properly educated before prescribing contraceptives. lastly, this note will examine and address pharmacists’ potential concerns about prescribing birth control. b. possible complications when there are gaps in receiving birth control molly jones is from a small town in southern indiana. 1 the summer before starting college, molly experienced severe pre-menstrual symptoms. the symptoms had grown so debilitating that molly had to miss work due to severe cramping and abdominal pain. molly visited a gynecologist located in her hometown the summer before molly started college. the physician prescribed molly birth control to help with the severe pre-menstrual symptoms and to help alleviate the pain that molly was experiencing. 2 after receiving the prescription, ————————————————————————————— * j.d. candidate, 2025, indiana university robert h. mckinney school of law; b.a. 2020, indiana university. the author extends a special thank you to professor stephanie boys, buddy lobermann, and reed overton for their invaluable feedback. 1. molly jones is a fictional character derived from a combination of personal stories the author has heard from close friends. her story helps describe the potential problems that can be derived when women experience gaps in their prescribed contraceptives. 2. see oshin m. bansode et al., contraception, statpearls (july 24, 2023 9:40 pm), https://www.statpearls.com/point-of-care/19940 [https://perma.cc/daq2-wb4f] (discussing certain medical reasons why women may be prescribed birth control). https://perma.cc/daq2-wb4f https://www.statpearls.com/point-of-care/19940 indiana health law review [vol. 22:187 188 molly started school at a college located about three hours away from her hometown. molly began taking the oral contraceptives, and the pain she had been experiencing substantially subsided. molly did not miss any classes in her first year of college. she made many new friends, joined student organizations, and even made the dean’s list in both semesters. molly enjoyed her time at school so much that she decided to apply to be a residential assistant to help incoming students the next school year. after molly’s first appointment, she scheduled another checkup with her same physician the following year. unfortunately, the appointment that molly had scheduled a year prior was to take place after she was already supposed to be back on campus. she called and requested an earlier appointment, but since it had not been a full year between appointments, her insurance would not cover the deductible. molly had to cancel her appointment and could not get another appointment until six months later. molly tried to refill her birth control prescription before going back to school, but unfortunately, she was unable to do so because she needed a new doctor’s prescription. molly then had to start the school year without her medication. after going off the birth control, molly’s menstrual pains reemerged. in fact, her symptoms returned even worse than what they were before. 3 because of the sudden hormonal changes, molly also developed hormonal acne around her jawline and began experiencing headaches and sudden mood swings. 4 molly started missing class because the menstrual pain was so bad. since molly was missing class, her grades began to drop. molly was no longer engaged in the social activities at school. since she was no longer taking her medication, she noticed that she was also increasingly more anxious and began to feel depressed. 5 after an extremely long and difficult semester, molly was finally able to go to her scheduled appointment six months later. she resumed taking the medication, and her symptoms subsided again. molly is now extremely careful to ensure that she does not miss another doctor’s appointment for fear that she might have to deal with another lapse in medication. unfortunately, molly’s story may not be the only reason women experience gaps in their birth control medication. women may forget their medication while traveling, or women may have to wait longer in between appointments ————————————————————————————— 3. jessica caporuscio, stopping birth control: what to expect and management, med. news today, https://www.medicalnewstoday.com/articles/stopping-birth-control [https://perma.cc/ df89-539g] (last updated oct. 26, 2023). (discussing possible symptoms that may result after coming off the birth control pill). 4. id. 5. id. https://perma.cc https://www.medicalnewstoday.com/articles/stopping-birth-control 2025] breaking barriers to birth control 189 due to physician shortages. 6 whenever a woman stops taking birth control, it results in a change of hormonal levels in the body because progesterone and/or estrogen is being removed from the body. 7 the lapse in medication could be especially problematic for women who are using birth control to treat symptoms such as polycystic ovary syndrome or who are using it as a form of family planning.8 women are prescribed birth control for a multitude of reasons. 9 it does not matter why a woman is prescribed birth control; women should not have to experience gaps in their medication just because they cannot get into their yearly scheduled physician’s appointment. by allowing pharmacists to prescribe birth control, women are less likely to experience a disruption in their medication just because they cannot get in to see a physician. the remainder of this note will further discuss the importance of the indiana code section 25-26-26 and how it should be properly implemented to ensure that women have greater access to oral contraceptives. ii. background a. discussing indiana code § 25-26-25 on july 1, 2023, the indiana legislature passed indiana code section 25-2625, which allows pharmacists to prescribe birth control. the statute allows pharmacists to “prescribe and dispense hormonal contraceptive patches and selfadministered hormonal contraceptives” without having a prescription from a practitioner. 10 this does not include injectable contraceptives or intrauterine devices, and pharmacists can only prescribe these self-administered contraceptives to women who are at least eighteen years of age. 11 women would not be required to schedule an appointment with the pharmacist before being prescribed the contraceptive. 12 indiana code section 25-26-25-3 states that the “self-administered ————————————————————————————— 6. cate charron, rural health care gaps complicate health outcomes. where does indiana stand?, inside ind. bus. (nov. 6, 2023), https://www.insideindianabusiness.com/articles/ruralhealth-care-gaps-complicate-health-outcomes-where-does-indiana-stand [https://perma.cc/p375q8j8]. 7. caporuscio, supra note 3. 8. john hopkins med., polycystic ovary syndrome (pcos), https://www.hopkinsmedicine. org/health/conditions-and-diseases/polycystic-ovary-syndrome-pcos#:~:text=pcos%20is%20a %20very%20common,%2c%20infertility%2c%20and%20weight%20gain [https://perma.cc/ jx8x-ql4y] (last visited feb. 4, 2024) (discussing polycystic ovary syndrome (pos) as a “condition in which the ovaries produce an abnormal amount of androgens,” which may cause “irregular periods, excessive body hair, weight gain, acne, hair loss, or infertility”; noting that birth control can “help regulate menstrual cycles, lower androgen levels, and reduce acne.”). 9. see bansode et al., supra note 2. 10. ind. code § 25-26-25-4 (2023). 11. id. 12. id. § 7. https://perma.cc https://www.hopkinsmedicine https://perma.cc/p375 https://www.insideindianabusiness.com/articles/rural indiana health law review [vol. 22:187 190 hormonal contraceptives” include hormonal contraceptive pills, which can be in the form of combination pills that contain both estrogen and progestin or progestin-only pills. 13 these pills are used to “[s]top or reduce ovulation,” “[t]hicken cervical mucus [by] creating a barrier that prevents sperm from entering [a] uterus and [reaching the] egg [and] [t]hin[ing] the lining of [a] uterus” to prevent a fertilized egg from growing.14 hormonal contraceptive patches are a “type of contraception that contains the hormones estrogen and progestin” that one can physically apply to their body to prevent pregnancy. 15 these two types of contraceptives are easy for women to use and help give women the power to choose whether they become pregnant. before pharmacists can prescribe birth control, they must complete a designated training program approved by the state health commissioner or designated public health authority. 16 the training program will educate pharmacists on “prescribing hormonal contraceptive patches and selfadministered hormonal contraceptives.” 17 in addition to completing the designated training program, pharmacists must ensure the woman completes a self-risk screening assessment, and the pharmacist must “[a]dminister the screening protocols” before they prescribe birth control. 18 the screening protocols may differ by state, but they may include gathering a patient’s “medical history, pregnancy status, . . . medication use . . . [a] blood-pressure check,” and patient preferences. 19 after prescribing birth control, pharmacists must “[r]efer the woman to a primary care practitioner or the women’s health care practitioner.” 20 additionally, pharmacists must supply “a written record of the hormonal…contraceptive prescribed” to the woman and recommend a consult with an appropriate practitioner. 21 these steps are similar to the ones that a physician would use before prescribing birth control. since the pharmacists must refer the woman to a physician, any underlying health problems that the woman may have can be quickly addressed. pharmacists only have the authority to prescribe the contraceptive for up to a six-month period. pharmacists “may not issue a prescription to the woman after twelve (12) months unless the woman has been seen by a physician, ————————————————————————————— 13. id. § 3.; see also birth control pills, clev. clinic, https://my.clevelandclinic.org/health/ treatments/3977-birth-control-the-pill [https://perma.cc/5z92-fz37] (last visited july 5, 2023). 14. cleveland clinic, supra note 13. 15. birth control patch, mayo clinic (feb. 9, 2023), https://www.mayoclinic.org/testsprocedures/birth-control-patch/about/pac-20384553 [https://perma.cc/gkx4-9nt6]. 16. ind. code § 25-26-25-5(c)(1) (2023). 17. id. 18. id.; ind. code § 25-26-25(c)(6) (2023). 19. christine chim & pallak sharma, pharmacists prescribing hormonal contraceptives: a status update, 46 u.s. pharm. 45, 48 (2021); see also kierra b. jones, advancing contraception access in states through expanded pharmacist prescribing, ctr. for am. progress (jan. 31, 2023), https://www.americanprogress.org/article/advancing-contraceptionaccess-in-states-through-expanded-pharmacist-prescribing/ [https://perma.cc/r7ve-97cz]. 20. ind. code § 25-26-25-5(c)(3) (2023). 21. id. § 5(c)(4). https://perma.cc/r7ve-97cz https://www.americanprogress.org/article/advancing-contraception https://perma.cc/gkx4-9nt6 https://www.mayoclinic.org/tests https://perma.cc/5z92-fz37 https://my.clevelandclinic.org/health 2025] breaking barriers to birth control 191 advanced practice registered nurse, or physician assistant in the previous twelve (12) month period.” 22 these provisions safeguard women’s health by ensuring that she does not go a prolong time without consulting a physician. furthermore, it is important to note that this statute does not require pharmacists to prescribe contraceptives if they feel as though the contraceptive is “contraindicated” or the pharmacists “objects on ethical, moral, or religious grounds.”23 nowhere does the statute require pharmacists to undergo the training necessary to be able to prescribe contraceptives. this allows pharmacists to decide whether they want to prescribe birth control. b. the legal right to contraception the right to use hormonal contraceptives derives from two supreme court cases: griswold v. connecticut 24 and eisenstadt v. baird. 25 griswold and eisenstadt were vital in giving women and families the ability to participate in family planning. the results of these cases gave women bodily autonomy and gave women the power to decide their future. in 1965, the united states supreme court held it was unconstitutional to prevent married couples from using contraceptives in griswold. 26 within this case, the supreme court declared a connecticut law that prevented the use of contraceptives for marital couples illegal. 27 the supreme court reached the conclusion “that a governmental purpose to control or prevent activities constitutionally subject to state regulation may not be achieved by means which sweep unnecessarily broadly and thereby invade the area of protected freedoms.” 28 this holding was the first step in ensuring that women had the right to contraceptives, but it notably left out unmarried women. the right to use contraceptives was extended to single individuals in eisenstadt. 29 the supreme court held that a state could not “outlaw [the] distribution [of contraceptives] to unmarried but not to married persons” and still be consistent with the equal protection clause. 30 this means that states could not bar access to women who were not married and gave single, not just married, women more power for family planning. 31 although this case allowed ————————————————————————————— 22. id. § 5(c)(7). 23. id. § 8. 24. 381 u.s. 479, 485 (1965). 25. 405 u.s. 438, 454–55 (1972). 26. 381 u.s. at 485 (quoting naacp v. alabama, 377 u.s. 288, 307 (1964)). 27. id. 28. id. at 480. 29. 405 u.s. at 454–55. 30. id. at 454. 31. see mabel felix et al., the right to contraception: state and federal actions, misinformation, and the courts, kff (oct. 26, 2023), https://www.kff.org/womens-healthpolicy/issue-brief/the-right-to-contraception-state-and-federal-actions-misinformation-and-thecourts/#:~:text=currently%2c%20the%20right%20to%20contraception,married%20people%20 to%20obtain%20contraceptives [https://perma.cc/slr5-2hhl]. https://perma.cc/slr5-2hhl https://www.kff.org/womens-health indiana health law review [vol. 22:187 192 the distribution of contraceptives, it produced no guarantee that women would be able to access the contraceptives when they need them. 32 only thirteen states currently protect the right to contraceptives through legal or constitutional provisions. 33 indiana is not one of those states. however, as long as the decisions in griswold and eisenstadt are not overturned by the supreme court, indiana residents will still maintain the right to contraceptives. 34 c. hormonal contraceptives differ from abortion-inducing drugs there are often misconceptions that hormonal contraceptives are related to abortion-inducing drugs, however, they are medically distinct. understanding the difference between hormonal contraceptives and abortion-inducing drugs is important because “fundamental misunderstandings regarding how contraceptives work – particularly how iuds and emergency contraceptive pills operate – present a situation in which legislators and regulatory agencies might conflate abortion and contraception, potentially restricting people’s ability to access these methods in some states.” 35 hormonal contraception is used to prevent pregnancy, 36 while an abortion is termination of a pregnancy. 37 contraceptives “work by inhibiting ovulation or by making it harder for sperm to reach an egg,” which, if used correctly can prevent a pregnancy from occurring.”38 this statute does not allow pharmacists to “knowingly or intentionally prescribe[] a drug…that is intended to cause an abortion.” 39 additionally, under the new statute, a pharmacist commits a level 5 felony if they prescribe an abortion-inducing drug.40 since indiana pharmacists have never been allowed to prescribe abortion-inducing drugs, this section of the statute seems to emphasize that the statute gives pharmacists the power to solely prescribe contraceptives. d. the effect on states that allow pharmacists to prescribe birth control as of january 23, 2023, twenty-four other states currently allow pharmacists to prescribe birth control, and several states currently have similar legislation pending.41 however, legislation in this area is still relatively new; only fourteen ————————————————————————————— 32. id. 33. id. 34. id. 35. id. 36. bansode et al., supra note 2. 37. abortion (termination of pregnancy), harv. health publ’g (jan. 9, 2019), https://www.health.harvard.edu/medical-tests-and-procedures/abortion-termination-ofpregnancy-a-to-z [https://perma.cc/nj3v-cfvh]. 38. felix et al., supra note 31. 39. ind. code § 25-26-25-9(a) (2023). 40. id. § 9(b). 41. jones, supra note 19. https://perma.cc/nj3v-cfvh https://www.health.harvard.edu/medical-tests-and-procedures/abortion-termination-of 2025] breaking barriers to birth control 193 of those twenty-four states had legislation passed before 2020. 42 most states allow pharmacists to prescribe birth control through a statewide protocol or a standing order and give the right to prescribe through a collaborative practice agreement (cpa).43 a collaborative practice agreement is “[a] formal agreement in which a licensed provider makes a diagnosis, supervise[s] patient care, and refers patients to a pharmacist under a protocol that allows the pharmacist to perform specific patient care functions.”44 a collaborative practice agreement allows the pharmacist to provide care services to the patients and in turn can “reduce fragmentation of care, lower health care costs, and improve health outcomes.”45 in 2016, california and oregon became the first two states to pass legislation that allowed pharmacists to prescribe birth control. 46 four other states, colorado, new mexico, hawaii, and maryland, quickly followed suit and also passed legislation. 47 the specific legislation allowing pharmacists to prescribe birth control varies from state to state. 48 the states’ statutes vary on the types of contraceptives that pharmacists may prescribe and what the pharmacists’ training requirements include. 49 state legislation also differs on the minimum age requirement and the time period for how long prescriptions can be refilled. 50 despite these differences, all state protocols require pharmacists to meet certain standards of screening, counseling, documenting, and monitoring. 51 this includes a screening questionnaire that is required by the cdc’s u.s. medical eligibility criteria for contraceptives that a woman must complete before the pharmacist can issue a prescription. 52 the questionnaires include questions that relate to a patient’s “medical history, pregnancy status, and medication use.” 53 if certain risk factors are identified within the questionnaire, the pharmacist may need a physician referral before they can prescribe the contraceptive. 54 these questionnaires help pharmacists identify the patient’s medical history to ensure that it is safe for the pharmacists to prescribe birth control. by identifying certain risk factors, pharmacists detect which patients are more likely to experience complications from taking contraceptives and which ones need to be monitored by a physician. ————————————————————————————— 42. id. 43. chim & sharma, supra note 19, at 45. 44. collaborative practice agreements and pharmacists’ patient care services, cdc 1 (2023), https://stacks.cdc.gov/view/cdc/49016 [https://perma.cc/nhk7-u72s]; see generally chim & sharma, supra note 19, at 45. 45. collaborative practice agreements and pharmacists’ patient care, supra note 44. 46. chim & sharma, supra note 19, at 45. 47. id. 48. id. at 46–47. 49. id. 50. id. 51. id. 52. id. at 46–47. 53. id. at 47. 54. id. https://perma.cc/nhk7-u72s https://stacks.cdc.gov/view/cdc/49016 indiana health law review [vol. 22:187 194 additionally, the national alliance of state pharmacy associations (naspa) issued legislation recommendations that allow pharmacists to prescribe birth control. 55 naspa recommends that state legislation should be general for specific medication categories and that states should not limit where pharmacists can prescribe birth control within the state. 56 naspa’s additional legislation recommendations include limiting delegations to nonpharmaceutical staff, requiring additional pharmaceutical training, and keeping documentation of records and communications with patients. 57 the indiana statute meets all of the above naspa recommendations, but the statute does not include any information about how the statute will affect insurance policies.58 naspa recommends that insurance policies should cover pharmacist-preformed services, like administering vaccines, in the same manner as physician-prescribed services. 59 without a reimbursement incentive, pharmacists may not undergo the proper training needed to prescribe birth control, which would still inhibit women’s ability to access contraceptives. examining some of the first states that allowed pharmacists to prescribe birth control provides insight on how the indiana statute should be implemented. 60 the oregon statute that allows pharmacists to prescribe birth control requires that “state and federal laws governing insurance coverage of contraceptives drugs, devices, products, and services shall apply to hormonal contraceptive patches and self-administered oral hormonal contraceptives prescribed by a pharmacists.” 61 the oregon board of pharmacy originally created a group of “pharmacists, pharmacy administrators, obstetricians and gynecologists, policymakers, and subject-matter experts” to provide suggestions for standard procedures. 62 oregon initially faced problems with finances and consultation costs, and although these issues have improved, the low number of pharmacists willing to prescribe contraceptives continues to be an issue. 63 in 2020, only 46% of pharmacists in oregon prescribed contraceptives, which is still significantly higher than in other states. 64 however, even with these numbers, it is estimated that the oregon policy allowing pharmacists to prescribe birth control, prevented more than fifty unintended ————————————————————————————— 55. nat’l all. st. pharmacy ass’n & nat’l ass’n bds. pharmacy, pharmacist statewide protocols: key elements for legislative and regulatory authority 1 (mar. 2017) [hereinafter legislative and regulatory authority]. 56. id. 57. id. at 5. 58. id. at 6. 59. id. at 3. 60. jones, supra note 19. 61. or. rev. stat. § 689.689 (2024). 62. jones, supra note 19. 63. id. 64. beyond the beltway: pharmacist prescribing of hormonal contraceptives, power to decide 1, 2 (may 3, 2023), https://powertodecide.org/sites/default/files/2023-05/pharmacist%20 prescribing_5-03-23_0.pdf [https://perma.cc/p69g-8lvm]; jones, supra note 19. https://perma.cc/p69g-8lvm https://powertodecide.org/sites/default/files/2023-05/pharmacist%20 2025] breaking barriers to birth control 195 pregnancies and saved the state $1.6 million after just two years of execution. 65 california is another state where a small number of pharmacists are providing birth control. in california, three years after the state allowed pharmacists to prescribe birth control, only 15% of pharmacies included this option.66 california and pharmacies in california have done little to advertise for the new services. 67 because the service has not been well advertised, women likely are not seeking the service, which could be misconstrued as a lack of interest in the service. the primary objective of the california legislation allowing pharmacists to prescribe birth control was to provide more options to underserved communities. 68 however, this is a hard task to accomplish if the underserved communities are not aware of the services. the ceo of the california pharmacists association, jon roth, believed that the biggest obstacle in getting pharmacists to prescribe birth control has been reimbursement. 69 this was also confirmed by a qualitative data survey, which also stated that this was the biggest obstacle in dispensing a year-long supply of birth control. 70 the survey found the second biggest obstacle was “whether the pharmacy had a protocol or policy allowing for such a large quantity of birth control.” 71 by looking at the problems exhibited in california, it shows how important it will be to provide reimbursement for indiana pharmacists and to advertise the new service. e. other states’ reimbursement policies proper compensation for pharmacists’ service is a primary concern. maryland illustrates how pharmacists can be properly compensated for their services.72 pharmacists can bill for patient consultations that determine a patient’s eligibility for contraception if the pharmacist enrolls in maryland’s medicaid pharmacist prescriber program. 73 pharmacists are reimbursed for their services by filing and billing through a specific form at the centers for medicare ————————————————————————————— 65. steve lundeberg, prescriptions written by pharmacists reducing risk of unwanted pregnancies, or. state univ. (may 23, 2019), https://news.oregonstate.edu/news/prescriptionswritten-pharmacists-reducing-risk-unwanted-pregnancies#:~:text=the%20study%20suggests% 20that%20in,million%20in%20associated%20taxpayer%20costs [https://perma.cc/m33yg829]. 66. fran kritz, pharmacists can now prescribe birth control, but few do, cal. health rep. (feb. 15, 2019), https://www.calhealthreport.org/2019/02/15/pharmacists-can-nowprescribe-birth-control-but-few-do-%ef%bb%bf/ [https://perma.cc/t7du-endk]. 67. id. 68. id. 69. id. 70. gelareh nikpour et. al, pharmacy implementation of a new law allowing year-long hormonal contraception supplies, 8 pharmacy 165, 171 (2020) (available at https://www. mdpi.com/2226-4787/8/3/165 [https://perma.cc/st5b-lvmm]). 71. id. 72. jones, supra note 19. 73. id. https://perma.cc/st5b-lvmm https://mdpi.com/2226-4787/8/3/165 https://www https://perma.cc/t7du-endk https://www.calhealthreport.org/2019/02/15/pharmacists-can-now https://perma.cc/m33y https://news.oregonstate.edu/news/prescriptions indiana health law review [vol. 22:187 196 and medicaid services. 74 this method is similar to what indiana pharmacists might currently use for reimbursement for other services. other states have diverse ways of compensating pharmacists as well. new mexico has incentivized pharmacists to prescribe birth control by reimbursing pharmacists at the same rate as other health care providers. 75 in hawaii, some hawaiian insurers have special billing codes for pharmacists, and the pharmacists are reimbursed for any of their services that promote contraceptive use. 76 reimbursing pharmacists at the state rate as other health care provider would perhaps being the greatest incentive for pharmacists to prescribe birth control because it would result in a higher reimbursement amount. f. importance of increasing access for young women and low-income groups by 2014, the affordable care act eliminated cost-sharing for most women who had commercial insurance, resulting in an increased use of prescription contraceptives.77 under the affordable care act, women can avoid copay or out-of-pocket costs for their birth control prescription through most employer health insurance plans, private insurers, or states’ marketplace plans if they have had a valid prescription for fda-approved birth control. 78 eliminating the costsharing for birth control was related to “more consistent contraceptive use and a decrease in birth rates among all income groups,” with the lowest income group experiencing the most dramatic decline in births. 79 the lowest income group saw a 22% decline of births. 80 however, those with insurance from private employers may not have received coverage because private employers have the option to not provide birth control coverage on moral or religious grounds. 81 for those individuals who have insurance plans that do not cover birth control, it is important that prescription costs remain low so they can still receive the medication that they need. encouraging pharmacy providers to provide services that give immediate ————————————————————————————— 74. id. 75. id. 76. id. 77. vaness k. dalton et al., trends in birth rates after elimination of cost sharing for contraception by the patient protection and affordable care act, 3 jama network, nov. 6, 2020, at 1, 2 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2772565 [https:// perma.cc/ssp2-uply]. 78. stephanie watson, birth control coverage: faq, webmd, https://www.webmd.com/ health-insurance/aca-birth-control-coverage-faq [https://perma.cc/aq9e-r5ug] (last updated sept. 17, 2022). 79. beata mostafavi, expanded birth control coverage may help reduce disparities in unplanned pregnancies, mich. med. (nov. 6, 2020, 11:00 am), https://www.michiganmedicine. org/health-lab/expanded-birth-control-coverage-may-help-reduce-disparities-unplannedpregnancies [https://perma.cc/6y8c-l5au]; see dalton et al., supra note 77. 80. mostafavi, supra note 79; see dalton, et al., supra note 77. 81. watson, supra note 78. https://perma.cc/6y8c-l5au https://www.michiganmedicine https://perma.cc/aq9e-r5ug https://www.webmd.com https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2772565 2025] breaking barriers to birth control 197 access to contraception options will help increase contraception access. 82 giving pharmacists the ability to prescribe birth control is especially important for young adults still seeing a pediatrician because many pediatricians do not feel comfortable prescribing contraception. 83 among teens who are currently sexually active, only 33% used effective hormonal birth control, and only 52% of teens used a condom the last time they had sexual intercourse. 84 black, asian, and hispanic teens were significantly less likely to use effective birth control than white teens.85 teen birth rates are currently at their lowest, but there were still over 145,000 infants born to teenagers in 2021. 86 allowing these young women to receive contraceptives at a pharmacy gives them access and the ability to receive contraceptives at the same place and day, especially in areas with physician deserts. same-day services that pharmacists can provide are especially important due to complications of “transportation, confidentiality, and school absences.” 87 additionally, confidentially breaches may occur through billing and insurance claims, which could have dangerous consequences for young adults who are still on their parents’ insurance plans. 88 billing and insurance claims are intended to prevent fraud, but they also notify the policyholders of the services that were provided under health insurance plans. 89 young adults can stay on their parents’ insurance plans until they reach age twenty-six. 90 these young adults may fear getting birth control prescriptions because they are afraid that billing information may be displayed to their parents. 91 being able to receive their prescription from a pharmacist may help young women over age eighteen use their discretion to make the choice that best fits their needs without having to disclose their private health information to their parents. ————————————————————————————— 82. sara green, in a post-roe world, access to contraception is critical for adolescents, child’s. hosp. phila. (oct. 31, 2022), https://policylab.chop.edu/blog/post-roe-world-accesscontraception-critical-adolescents [https://perma.cc/s87z-jqng]. 83. id. 84. youth risk behavior survey data summary & trends report: 2011–2021, cdc 11 (2021) (available at https://www.cdc.gov/healthyyouth/data/yrbs/pdf/yrbs_data-summarytrends_report2023_508.pdf [https://perma.cc/hxn7-dutj]). 85. id. at 21. 86. id. at 11. 87. green, supra note 82. 88. gale r. burstein et al., confidentiality protections for adolescents and young adults in the health care billing and insurance claims process, 58 j. adolescent health, 374, 375–76 (2016). 89. id. at 375. 90. id. at 376. 91. id. https://perma.cc/hxn7-dutj https://www.cdc.gov/healthyyouth/data/yrbs/pdf/yrbs_data-summary https://perma.cc/s87z-jqng https://policylab.chop.edu/blog/post-roe-world-access indiana health law review [vol. 22:187 198 g. pharmacists’ concerns although 79.1% of pharmacy preceptors surveyed from the two indiana pharmaceutical schools, butler university and purdue university, expressed an interest in providing contraceptive services, only 35.6% felt they currently had the resources to prescribe contraceptives. 92 these numbers are similar to the 46% of oregon pharmacists who did not prescribe birth control, indicating that pharmacists’ amount of training could be an indicator of those who elect to take on the services. 93 pharmacists could also be potentially limited by their employer and what services they are allowed to provide. pharmacists may also have liability concerns with prescribing contraceptives. 94 of the pharmacist preceptors in indiana who said they did not have an interest in prescribing contraceptives, 80.7% were concerned with potential liability risks. 95 it is important that these concerns of pharmacists are addressed; otherwise, indiana pharmacists may not be willing to prescribe birth control. h. what retailers are prescribing birth control of the ten largest retail pharmacies in the united states, only five allow pharmacists to prescribe birth control: cvs pharmacy, good neighbor pharmacy, rite aid, safeway pharmacy, and albertsons. 96 whether the pharmacist can prescribe birth control does vary depending on the retailer’s location.97 some retailers allow walk-in consultations, while other may require an ————————————————————————————— 92. jenny l. newlon et al., pharmacists’ perceptions, barriers, and potential solutions to implementing a direct pharmacy access policy in indiana, 78 med. care res. rev. 789, 789 (2020). 93. jones, supra note 19. 94. newlon et al., supra note 92, at 792. 95. id. 96. 10 largest pharmacies in the united states in 2023, scrapehero, https://www. scrapehero.com/location-reports/10-largest-pharmacies-in-the-usa/#:~:text=cvs%20pharmacy %2c%20walgreens%20and%20health,4%2c688%20locations%20in%20the%20us [https:// perma.cc/nd65-ckty] (last visited feb. 1, 2024). 97. see generally birth control in your control, cvs, https://www.cvs.com/content/ pharmacy/womens-health [https://perma.cc/cl9a-gz7l] (last visited feb. 1, 2024) [hereinafter cvs]; birth control, your way, riteaid, https://www.riteaid.com/pharmacy/services/birthcontrol [https://perma.cc/l8m8-d444] (last visited feb. 1, 2024) [hereinafter riteaid] ; michael johnson, albertsons first to bill oregon medicaid for birth control consult, drug store news, https://drugstorenews.com/pharmacy/albertsons-first-bill-oregon-medicaid-birth-control-consult [https://perma.cc/6na5-37ar] (last visited feb. 1, 2024) [hereinafter albertsons]; store news & updates, good neighbor pharmacy, https://www.mygnp.com/pharmacies/munsey-pharmacyoak-ridge-tn-37830/news/appointments-available-to-book-online/ [https://perma.cc/g35y79mb] (last visited feb. 1, 2024) [hereinafter good neighbor pharmacy]; our pharmacists can prescribe select medications, safeway, https://www.safeway.com/pharmacy/careservices/pharmacist-prescribing-services.html#:~:text=va%20and%20vt.-,birth%20control,% 2c%20ut%2c%20va%20and%20vt [https://perma.cc/94fl-nkwd] (last visited feb. 1, 2024) [hereinafter safeway]. https://perma.cc/94fl-nkwd https://www.safeway.com/pharmacy/care https://perma.cc/g35y https://www.mygnp.com/pharmacies/munsey-pharmacy https://perma.cc/6na5-37ar https://drugstorenews.com/pharmacy/albertsons-first-bill-oregon-medicaid-birth-control-consult https://perma.cc/l8m8-d444 https://www.riteaid.com/pharmacy/services/birth https://perma.cc/cl9a-gz7l https://www.cvs.com/content https://www 2025] breaking barriers to birth control 199 appointment. 98 the process to schedule an appointment can take place online or by using a cell phone.99 both options allowed a woman needing birth control to see a pharmacist on the same day. 100 depending on your insurance coverage, cvs offers the ability to “consult with a pharmacist who can recommend and prescribe a birth control best for your goals for $39.” 101 cvs pharmacies that are located in indiana do not currently offer this service, but cvs pharmacies do offer it in ten other states. 102 this option allows women the ability to continue their birth control subscriptions if they forget their medication on vacation. 103 it also allows women to continue their medication without having to wait weeks or months to schedule an appointment with a physician. 104 this is especially important if a woman has recently moved or is trying to find a new physician. purdue university pharmacy was one of the first pharmacies in indiana that prescribed birth control. 105 in march 2024, the consultation for a fee for this service was $45, which does not include the cost of the actual prescription. 106 however, indiana code section 25-26-25 does not currently include any type of reimbursement plan nor does it include any guidance on how pharmacists should bill for their services. 107 to effectively increase the availability of contraceptives, indiana will need to provide pharmacists with incentives to perform the additional services. specific concerns that pharmacists may have prescribing birth control prescriptions need to be addressed as well. iii. analysis a. pharmacists need financial incentives to prescribe birth control pharmacists who elect to prescribe contraceptives take on an entirely new job duty. pharmacists would no longer be filling a prescription authorized by a physician, but instead, they would now be prescribing the medication themselves. the pharmacists would be giving women clinical approval to a medication that may come with many side effects. this is an additional duty that a pharmacist would be adding to their already potentially busy schedule. pharmacists’ most basic responsibilities are ensuring that the medications patients receive meet quality standards and advising patients on how to take ————————————————————————————— 98. see sources cited supra note 97. 99. see id. 100. see id. 101. see cvs, supra note 97. 102. see id. 103. see id. 104. see id. 105. clinical services, purdue univ., https://www.purdue.edu/rx/services/index.php [https://perma.cc/cp7b-hlk3] (last visited mar. 3, 2024). 106. id. 107. see generally ind. code § 25-26-25 (2024). https://perma.cc/cp7b-hlk3 https://www.purdue.edu/rx/services/index.php indiana health law review [vol. 22:187 200 their medication. 108 depending on the pharmacist’s employer, a pharmacist may have other duties as well. 109 pharmacists have to oversee the medication supply chain, ensure that the medications administered are safely distributed, manage medication production, evaluate the medicine quality, and make recommendations on medicine available for sale. 110 additionally, pharmacists may be responsible for “provid[ing] services to patients, such as smoking cessation, blood pressure measurement, and cholesterol management.” 111 asking pharmacists to prescribe birth control is adding another task to the pharmacists’ to-do list. furthermore, there is a pharmacist shortage throughout the united states. 112 the number of pharmacy graduates decreased from 14,223 in 2021 to 13,323 in 2022.113 this is a 6.3% decrease, which is the largest decrease in pharmacy graduates since 1983.114 perhaps even more concerning is that the pharmacy college application service accepted only 9,743 students by the 2023 deadline. this would be almost a 31.5% decrease from 2021. 115 this shows that there could be a shortage of pharmacists in the future. the pharmacists may not be pressed to take on additional tasks that are not currently expected of them. for this new service to be financially sustainable, pharmacists must be reimbursed for this new service that they are providing. 116 since indiana pharmacists are not deemed to be providers under collaborative practice agreements, they cannot bill directly for any patient care service that they provide. 117 this means that pharmacists could not bill directly for any consultations that they had with patients before prescribing birth control or any time that it took to evaluate the patient’s pre-screening questionnaires. to be eligible for reimbursement of their services through insurance, the pharmacists would need to be working “under a statewide protocol or autonomous prescriptive authority.” 118 this is why changes must be made regarding how pharmacists can bill for their services; otherwise, they have no monetary ————————————————————————————— 108. what does a pharmacist do?, gen. pharm. council, https://www. pharmacyregulation.org/raising-concerns/raising-concerns-about-pharmacy-professional/whatexpect-your-pharmacy/what-does-0 [https://perma.cc/w22j-5xqz] (last visited feb. 1, 2024). 109. id. 110. id. 111. id. 112. shawn spencer, the pharmacist shortage: a tipping point in healthcare, pcom (nov. 15, 2023), https://www.pcom.edu/academics/programs-and-degrees/doctor-of-pharmacy/ school-of-pharmacy/blog/the-pharmacist-shortage.html [https://perma.cc/7cms-clu6]. 113. id. 114. id. (the percentage decrease was calculated by subtracting the number of graduates from the previous year from the current number, dividing the result by the number of graduates from the previous year, and multiplying by 100). 115. percentage of decrease was calculated by taking the current number of graduates minus the number of graduates from the previous year and then dividing that sum by the graduates from the previous year and multiplying by 100. 116. newlon et al., supra note 92, at 795. 117. id. 118. id. https://perma.cc/7cms-clu6 https://www.pcom.edu/academics/programs-and-degrees/doctor-of-pharmacy https://perma.cc/w22j-5xqz https://pharmacyregulation.org/raising-concerns/raising-concerns-about-pharmacy-professional/what https://www 2025] breaking barriers to birth control 201 incentive for taking the additional time to prescribe birth control. pharmacists are now typically reimbursed for the prescription drug they dispense, typically known as a dispensing fee. 119 this means that pharmacists are billing under a pharmacy benefit instead of a medical benefit. 120 therefore, pharmacists must bill as a medical provider to receive compensation for their time prescribing the contraceptive. 121 to bill as a medical provider, pharmacists must be “enrolled[ed] in medicaid; be credentialed by, and contract with, health insurance plans (including commercial and medicaid plans, where applicable); submit medical claims; and use medical coding practices.”122 prescribing contraceptives requires additional accommodations that pharmacies do not currently have. 123 pharmacy preceptors surveyed at butler university and purdue university agreed that for pharmacists to prescribe contraceptives, pharmacists would need not only insurance reimbursement, but also more training, possibly a room for private counseling, and perhaps most importantly, more time. 124 due to the added burden and time this would place on pharmacists, an adequate reimbursement plan is essential because, without one, it is unlikely that pharmacists would be willing to provide an additional service. possible implementation methods that could be used to reimburse pharmacists can be viewed by looking at other states’ protocols. as previously stated, new mexico reimburses pharmacists at the exact rate that a physician could use when billing for those same services. 125 if indiana were to implement this same reimbursement rate, then pharmacists could be adequately compensated for their services. currently, indiana does not require pharmacists to conduct an appointment with patients before prescribing birth control. 126 however, the pharmacists who opted to conduct an appointment could be able to bill at the same rate as a physician by following new mexico’s reimbursement policy. 127 to accomplish this, indiana pharmacists would need to be considered physicians under a collaborative practice agreement. this would be a reasonable solution because pharmacists may, in fact, provide just as much, if not more, screening preventatives than a physician. this is especially true for physician appointments that take place via telehealth. the physicians who perform visits via telehealth are permitted to prescribe ————————————————————————————— 119. allison orris et al., implementing pharmacist contraceptive prescribing: a playbook for states and stakeholders, manatt 1, 18 (jan. 2021), https://www.manatt.com/manatt/media/ documents/articles/implementing-pharmacist-contraceptive-prescribing_v3.pdf [https://perma. cc/tq7r-2ul9]. 120. id. 121. id. 122. id. 123. newlon et al., supra note 92, at 795. 124. id. 125. jones, supra note 19. 126. see ind. code § 25-26-25-7 (2024). 127. see jones, supra note 19. https://perma https://www.manatt.com/manatt/media indiana health law review [vol. 22:187 202 medications without seeing the patient, and therefore, the other preventative screening recommended by a gynecologist would not take place either. 128 telehealth visits may take place through “secured videoconferencing,” “storeand-forward technology,” and “remote patient monitoring technology.” 129 the physician is not required to conduct an in-person appointment with the patient before they prescribe the medication. 130 pharmacists would at least be able to check a patient’s blood pressure, which is something that could not be conducted through a telehealth appointment since telehealth appointments take place electronically. in today’s world of growing telehealth appointments, there are services where physicians can prescribe contraceptives to their patients without ever seeing the patient face-to-face. therefore, even if a pharmacist did not choose to have an initial consultation with a patient, this would be like the services that healthcare providers already use. thus, it would be understandable that pharmacists could be reimbursed at an identical rate. another possible method of reimbursement would be for pharmacists to have special billing codes that coincide with the services of prescribing birth control.131 states, such as maryland and hawaii, have taken on this method. 132 in maryland, pharmacists who are medicaid providers may bill maryland medicaid when they conduct maryland’s required patient assessment before prescribing birth control. 133 pharmacists use different billing codes depending on whether the patient is new or already established. 134 hawaii also uses similar billing codes for new or established patients. 135 pharmacists bill more for new patients since it is expected that the assessment will take more time to complete. 136 a research study in oregon estimated that it would take pharmacists approximately fifteen to twenty minutes to complete a patient assessment. 137 pharmacists then required an additional five to eight minutes to fill and issue the prescription to the patient. 138 ————————————————————————————— 128. ind. code § 25-1-9.5-8 (2024). 129. telehealth and virtual services, ind. health coverage programs provider reference module 1 (2022) (available at https://www.in.gov/medicaid/providers/files/modules/ telehealth-and-virtual-services.pdf [https://perma.cc/q383-yvnw]); see also ind. code § 25-19.5-6 (2024). 130. josh archambault & vittorio nastasi, rating the states on telehealth best practices: a toolkit for a pro-patient and provider landscape 5 (2022) (available at https://reason.org/wp-content/uploads/rating-states-on-telehealth-best-practices.pdf [https:// perma.cc/zr2v-yht6]). 131. jones, supra note 19. 132. id. 133. orris, et al., supra note 119. 134. id. 135. id. 136. id. 137.id.; see timothy p. frost, et al., time and motion study of pharmacist prescribing of oral hormonal contraceptive in oregon community pharmacies, 59 j. am. pharm. assoc. 222, 222–27 (2019). 138. frost, supra note 137, at 225. https://reason.org/wp-content/uploads/rating-states-on-telehealth-best-practices.pdf https://perma.cc/q383-yvnw https://www.in.gov/medicaid/providers/files/modules 2025] breaking barriers to birth control 203 depending on the state, certain services relating to prescribing contraceptives may or may not be reimbursed. 139 the difference in reimbursement opportunities could determine what services pharmacists are able and willing to render in each state. 140 educating pharmacists on the proper billing codes to issue is another training aspect that would also be needed for pharmacists. 141 without certain state standards set in place, insurance providers may not reimburse pharmacists for their services, and reimbursing pharmacists is critical. 142 although pharmacists already perform similar tasks, if a pharmacist decides to prescribe birth control, they are taking on another responsibility and cannot be expected to do that without a financial benefit. if pharmacists did not have a reimbursement method offered by the state, pharmacists could potentially charge consumers directly for their services. 143 pharmacists would charge customers for the service of prescribing the contraceptive while also claiming reimbursement for the contraceptive. 144 this method, however, may be ineffective for serving women of low income because it could restrain access. 145 women of lower income may not likely be able to afford the cost and thus would be unable to take advantage of the service. states could also increase medicaid dispensing fees for birth control to cover the additional services that pharmacists are providing. 146 medicaid dispensing fees range between $9 to $12 for each prescription, depending on the state. 147 illinois increased the dispensing fee for certain birth control methods to $35 in 2014 with the goal of improving access to contraceptives. 148 however, this method could also negatively impact low-income persons for the same reason if pharmacists directly charged their customers. 149 this may be more effective if indiana could require all other insurance payers to raise fees, but the state only has control in raising the fees for medicaid patients. this method would likely not be as effective because there is a wide variety of other insurance payers. of these available reimbursement methods, reimbursing pharmacists as a provider would be the most effective. pharmacists are providing the same services that a physician would provide. pharmacists would be taking the time to discuss with each patient and review their medical history before prescribing the medication. this is like if the patient was receiving care from a physician. the billing codes that could be utilized by physicians could also be the same to ————————————————————————————— 139. jones, supra note 19. 140. id. 141. id. 142. spencer, supra note 112. 143. orris, et al., supra note 119, at 9. 144. id. 145. id. at 7. 146.id. at 19. 147. id. 148. id. at 9. 149. see generally id. at 19. indiana health law review [vol. 22:187 204 ensure proper reimbursement. this would also help provide pharmacists with the financial incentive that they would need to provide another service to their patients. if pharmacists are not reimbursed adequately, then their likelihood of wanting to provide these services would probably decrease. b. addressing the concerns that a patient may no longer receive necessary screenings to combat any concerns that patients may no longer attend their yearly screenings, indiana code section 25-26-25-5, says that pharmacists can only issue the prescription to a patient for a year. 150 then, the patient must meet with their physician before the pharmacists can prescribe birth control to them again. 151 there may be possible ways that patients would try to avoid seeing a physician, which could include visiting multiple pharmacists to avoid an annual exam. however, pharmacies, including larger retail pharmacies, keep detailed records of what medications patients have currently been prescribed. 152 this would mean that a patient would not be able to go from one pharmacy to another to get their prescription refilled. instead, the patient would have to seek out a different pharmacist from another retailer in their area. one of the concerns with allowing pharmacists to prescribe birth control is that women would not receive their original preventative screenings. 153 however, the american college of obstetrician and gynecologist committee has deemed that “[p]elvic and breast examinations, cervical cancer screening, and sexually transmitted infection screening are not required before initiating hormonal contraception and should not be used as reasons to deny access to hormonal contraception.” 154 women twenty-one to twenty-nine years old are now only recommended to receive a pap test once every three years with their physicians.155 this has decreased the time between pap tests, which used to be ————————————————————————————— 150. ind. code § 25-26-25-5 (2024). 151. id. 152. see generally, cvs, view prescription history, https://www.cvs.com/retail/help/helpsubtopic-view-print-prescription-history#:~:text=just%20sign%20in%20to%20your,also%20 can%20print%20prescription%20records [https://perma.cc/7cd5-b8zn] (last visited mar. 10, 2024). 153. chim & sharma, supra note 19, at 48. 154. over-the-counter access to hormonal contraception: committee opinion 788, am. coll. obstetrician & gynecologists, (oct. 2019, reaffirmed 2021), https://www.acog.org/ clinical/clinical-guidance/committee-opinion/articles/2019/10/over-the-counter-access-tohormonal-contraception [https://perma.cc/bcd6-6z79] [hereinafter am. coll.]. 155. get screened for cervical cancer, off. disease prevention & health promotion, https://health.gov/myhealthfinder/doctor-visits/screening-tests/get-screened-cervical-cancer#:~: text=if%20you're%20age%2021,years%20with%20an%20hpv%20test [https://perma.cc/ gkc8-7smr] (last updated mar. 10, 2024). https://perma.cc https://health.gov/myhealthfinder/doctor-visits/screening-tests/get-screened-cervical-cancer https://perma.cc/bcd6-6z79 https://www.acog.org https://perma.cc/7cd5-b8zn https://www.cvs.com/retail/help/help 2025] breaking barriers to birth control 205 one year. 156 pap tests “mainly check for changes that may turn into cervical cancer.” 157 sticking to a recommended testing schedule helps prevent most cervical cancers. 158 although it is still recommended that patients see a gynecologist each year to check to talk about potential problems with pelvic pain, abnormal bleeding, or breast exams since indiana pharmacists can only issue a prescription for up to six months, this would only push back a regularly scheduled appointment by six months. 159 therefore, waiting an additional six months would likely not significantly delay any recommended screening. c. addressing pharmacists’ liability concerns when prescribing medications states vary on what type of birth control they allow pharmacists to prescribe. 160 some states allow all current forms of birth control, while some states only allow pharmacists to prescribe self-administered contraceptives. 161 indiana pharmacists are only able to prescribe self-administered contraceptive, which gives indiana pharmacists less liability compared to pharmacists in other states. indiana pharmacists were most comfortable prescribing contraceptives in the form of a combined oral pill, progestin-only oral pill, and a transdermal patch. 162 these are the forms of contraceptives allowed by the indiana statute. 163 the indiana statute is stricter than other states’ statutes in relationship to the age requirement and the fact that pharmacists can only prescribe contraceptives for a year before patients have to see a primary care physician. 164 although these protocols may make contraceptives less accessible to women in indiana compared to women in other states, the statute does help limit pharmacists’ liability because they cannot prescribe them to minors. it also helps ensure that any dangerous side effects that a pharmacist may not notice may be recognized by a physician before a woman is on the prescription for too long. pharmacists may worry that indiana code section 25-26-25 does not require pharmacists to perform consultations with the patient. this does give pharmacists broad discretion, and pharmacists may wonder if the pre-risk assessment is enough to evaluate if someone should be prescribed contraceptives. however, the risk assessment typically includes questions that ————————————————————————————— 156. david mutch, why annual pap smears are history—but routine ob-gyn visits are not, am. coll. obstetrician & gynecologists, https://www.acog.org/womens-health/expertsand-stories/the-latest/why-annual-pap-smears-are-history-but-routine-ob-gyn-visits-are-not [https://perma.cc/7tyy-u6qw] (last updated apr. 2021). 157. pap test, medline plus, https://medlineplus.gov/ency/article/003911.htm [https:// perma.cc/pt5d-dw6f] (last updated jan. 1, 2023). 158. id. 159. mutch, supra note 156. 160. chim & sharma, supra note 19, at 46–47. 161. id. 162. newlon et al., supra note 92, at 792. 163. ind. code § 25-26-25-4 (2024). 164. see id § 5. https://medlineplus.gov/ency/article/003911.htm https://perma.cc/7tyy-u6qw https://www.acog.org/womens-health/experts indiana health law review [vol. 22:187 206 meet the cdc’s u.s. medical eligibility criteria for contraceptive use. 165 additional services may be needed depending on the patient’s medical history and the type of contraceptive prescribed. 166 for example, if the specific contraceptive prescribed is not safe for those with high blood pressure and the patient has hypertension, then the pharmacist may need to perform a blood pressure check. 167 the pharmacist would refer the woman to a physician if there were any indications that the hormonal contraceptive might be ineffective or unsafe for the patient. 168 the pharmacist would not need to prescribe birth control if it could place the patient at risk. 169 on july 13, 2023, the fda approved over-the-counter progestin-only oral contraceptives. 170 before the fda approves a medication in a nonprescription setting, it must be shown that the consumers can take medication without the help of a healthcare professional. 171 this shows that the fda believes that certain birth control medications do not need to be prescribed by your standard physician. the fact that the fda believes that a physician’s prescription is not necessary for birth control helps emphasize the fact that pharmacists—a different kind of healthcare professional—are more than capable of safely prescribing birth control. the fda approval helps increase women’s availability to contraception access, but it does render the pharmacists’ service of prescribing birth control obsolete. the fda has only approved over-the-counter contraceptives in one form, the opill, a norgestrel tablet. 172 there are many different types of contraceptive options available to women. a pharmacist can help determine the type of contraceptive that is best for each individual. if the woman opts for the contraceptive in pill form, the pharmacist can also determine what type of pill would best meet her needs. this is more indicative of what would occur if the woman was seeking a contraceptive prescription from a physician. additionally, the cost and timeline for over-the-counter contraceptives would be determined by the manufacturer. there is no cover date when opill would be available to consumers, and currently, there is no guarantee the contraceptives would be available at an affordable cost. 173 therefore, giving pharmacists the ability to prescribe birth control remains a crucial factor to ensuring women have access to contraceptives. pharmacists and physicians need to understand that allowing pharmacists to ————————————————————————————— 165. chim & sharma, supra note 19, at 46–47. 166. id. at 47–48. 167. id. at 48. 168. id. 169. id. 170. fda approves first nonprescription daily oral contraceptive, u.s. food & drug admin. (july 13, 2023), https://www.fda.gov/news-events/press-announcements/fda-approvesfirst-nonprescription-daily-oral-contraceptive [https://perma.cc/zj2n-r3u2]. 171. id. 172. id. 173. id. https://perma.cc/zj2n-r3u2 https://www.fda.gov/news-events/press-announcements/fda-approves 2025] breaking barriers to birth control 207 prescribe birth control would not replace the physician’s traditional duties but would instead be a way to assist physicians. the indiana court of appeals has recognized that a “recognition of a duty on the part of the pharmacists will not replace the physician’s obligation to evaluate a patient’s needs.” 174 pharmacists and physicians have a legal duty to work together to serve the best interest of their patients.175 pharmacists are already required to warn patients about the side effects of prescription medication when they dispense them which requires the pharmacist to possess “knowledge of the nature of the drug” and have knowledge of the patient’s medical history. 176 prescribing birth control medication is a new step for pharmacists because they are now making recommendations for the patients, but it is not completely out of the pharmacists’ wheelhouse. d. other concerns relating to women not visiting physician numerous studies have shown that women can effectively use selfscreening tools when determining if a certain medication is safe for them to use. 177 these questionnaires can help identify medical conditionals that a woman may have that might make it unsafe for them to be on birth control. 178 the indiana preliminary draft for screening questions about control includes questions about their past history with birth control methods and questions about specific medical conditions and symptoms. 179 the questionnaire questions the woman on whether she has had or is planning to have surgery in the near future, and asks multiple questions about whether the patient has had blood clots. 180 lastly, the questionnaire asks patients what their specific goals are by going on birth control. 181 this is especially important because not all women want to go on birth control to prevent pregnancies and there could be other forms of medication to best meet their needs. it also helps pharmacists identify which type of birth control may best fit the patients’ needs. specific questions on the questionnaires provides pharmacists more insurance that the patient has not forgotten critical information, and it encourages the patient to list information that the patient may not have originally deemed relevant to receiving a contraceptive prescription. ————————————————————————————— 174. kolozsvari v. doe, 943 n.e.2d 823, 827 (ind. ct. app. 2011). 175. hooks superx, inc. v. mclaughlin, 642 n.e.2d 514, 519 (ind. 1994). 176. 856 ind. admin. code 1-23-1 (2024); see also ingram v. hook's drugs, inc., 476 n.e.2d 881, 885 (ind. ct. app. 1985). 177. am. coll., supra note 154. 178. see generally id. 179. screening questions for birth control, ind. dep’t health 1, 1, https://www. in.gov/health/files/dr.-weaver-statewide-standing-order-for-administration-of-hormonalcontraceptives-cso-23-11-appendix-c_september-1-2023.pdf [https://perma.cc/x95a-278j] (last visited mar. 10, 2024). 180. id. 181. id. at 2. https://perma.cc/x95a-278j https://in.gov/health/files/dr.-weaver-statewide-standing-order-for-administration-of-hormonal https://www indiana health law review [vol. 22:187 208 other possible concerns are that pharmacists may not receive thorough documentation of a patient’s medical history because they only have the information that the patient chooses to disclose. 182 patients may choose not to disclose all the medical documentation, or they may be unaware of all of their “underlying medical conditions.” 183 however, it is important to note that this is an issue that physicians may face as well. there are some negative side effects that occur when taking contraceptives, such as “nausea, headaches, irritability or moodiness, breast [] tenderness or swelling, or abnormal menstruation.” 184 those side effects, along with “[a]n increased risk of blood-clotting problems, heart attack, stroke, liver cancer, gallbladder disease, and high blood pressure” and “skin irritation…weight gain, dizziness, acne, diarrhea, muscle spasm, vaginal infections and discharge, fatigue, and fluid retention” could occur from the birth control patch. 185 these effects could be exasperated depending on a patient’s medical conditions, which is why knowing the patient’s medical history is crucial. 186 this is why the screening questionnaires that pharmacists would have patients use would be a crucial part of the process of describing birth control. physicians have unique concerns about pharmacist prescribing birth control. healthcare providers expressed certain concerns about over-the-counter birth control which included a “potential decrease in preventive screenings, changes to the patient-provider relationship” and decrease in patients and revenue. 187 although these concerns may be valid, since pharmacists cannot prescribe birth control to a patient for more than a year without the patient seeing a physician, physicians would still be able to maintain a patient-relationship with women that receive their initial birth control prescription for a pharmacist. iv. training pharmacists need to help address their liability concerns there is a “home study training program” available to pharmacists for $150 that is a “[l]ecture presentation with interactive questions and clinical case applications.”188 this course is accepted by the indiana board of pharmacy and meets the required training allowing pharmacists to prescribe birth control. 189 after completing the course, pharmacists should be able to: ————————————————————————————— 182. see generally chim & sharma, supra note 19, at 48. 183. id. 184. birth control pills, supra note 13. 185. birth control patch, supra note 15. 186. chim & sharma, supra note 19, at 180. 187. am. coll., supra note 154. 188. indiana pharmacist contraception services training program, birth control pharmacist, https://birthcontrolpharmacist.com/training/in/ [https://perma.cc/vdn6-9xfu] (last visited feb. 4, 2024). 189. id. https://perma.cc/vdn6-9xfu https://birthcontrolpharmacist.com/training/in 2025] breaking barriers to birth control 209 (1) discuss the impact of barriers to contraceptive use. (2) describe pharmacist procedures for contraception services. (3) identify appropriate screening assessments for the various methods of contraception. (4) apply the medical eligibility criteria for contraceptive use to individual patients. (5) provide accurate patient counseling about the mechanism, effectiveness, benefits, risks, and instructions for use for contraception methods. (6) assist patients in selecting method(s) of contraception. (7) manage side effects and refer for further evaluation when appropriate. (8) implement contraception prescribing in a pharmacy practice setting. 190 this course would provide pharmacists with more knowledge about prescribing hormonal contraception and would hopefully make them feel more comfortable offering this additional service. a. publicity matters: the public needs to be informed regarding the new legislation so that women benefit information about the new indiana statute needs to be publicized to ensure that women are aware that contraceptives are now more readily accessible. additionally, physicians should be educating their patients on the importance of continued use of their prescriptions. physicians can notify their female patients of what could occur if they quit taking their contraceptives when they are in between prescriptions. if a physician knows they will not be able to refill a prescription via appointment in time, they could notify their patient that the prescription could be prescribed by a pharmacist to prevent any disruptions in receiving medication. indiana code section 25-26-25 will allow pharmacists to prescribe access to younger women who may have situational barriers that prevent them from being able to see a physician. it could also help prevent women from obtaining additional and unneeded medical costs that may come from visiting a physician. this is especially true when women lack health insurance coverage. in indiana, 9.4% of women ages fifteen to forty-four do not have any insurance at all. 191 allowing pharmacists to prescribe birth control can help cover the gaps when patients may not be able to see a physician due to financial or other constraints. further, 65.25% of all abortions occurred between females ages eighteen to twenty-nine in indiana in 2022. 192 some of these young women may still be on their parent’s health insurance and may be afraid that the policyholder would be ————————————————————————————— 190. id. 191. maternity care desert, march dimes, https://www.marchofdimes.org/peristats/ data?reg=18&top=23&stop=643&lev=1&slev=4&obj=9&sreg=18 [https://perma.cc/x45tpdtx] (last updated dec. 2023). 192. lindsay m. weaver et al., div. vital recs. 2022 terminated pregnancy rep. 12 (2023) (available at https://www.in.gov/health/vital-records/files/2022-tpr-annual.pdf [https:// perma.cc/wt9b-bay5]). https://www.in.gov/health/vital-records/files/2022-tpr-annual.pdf https://perma.cc/x45t https://www.marchofdimes.org/peristats indiana health law review [vol. 22:187 210 able to see whether they were on contraceptives.193 providing these women with knowledge about family planning and access to contraceptives is critical to ensure they can make the best choice for their future. this is another reason to ensure that these age groups are aware of the new way they could obtain contraceptives. nearly “45% of all pregnancies are unintended.” 194 there are two different types of unintended pregnancies, which include those that are “mistimed and unwanted.”195 unplanned pregnancies, regardless of whether they are unintended or unwanted, can be detrimental to the health of the mother and the child.196 these numbers are important because “[u]nintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.” 197 mistimed birth resulted in “an estimated $5 billion per year in direct and indirect costs for the u.s. health care system.” 198 unwanted pregnancies can be even more problematic. they are often associated with maternal depression, which can influence a child’s early development. 199 children from unwanted pregnancies are more likely to suffer from domestic violence. 200 they also may be more likely to witness “parental intimate partner violence” and experience conduct and attention problems. 201 by increasing access to contraceptives, the risk of unwanted pregnancies in indiana can also be reduced. medicaid pays for more than half of the pregnancies and deliveries in indiana. 202 indiana state representative, rita fleming, a physician, estimated that “reducing unintended pregnancies and births by even 10% through improved access to long-acting reversible contraception would save [the state] $86 million a year.” 203 although this estimate is for a different kind of contraception not related to what pharmacists can prescribe, it shows the impact that access to contraception can provide. additionally, by “averting unintended pregnancies and other negative ————————————————————————————— 193. burstein, supra note 88, at 376. 194. chim & sharma, supra note 19; see also newlon et al., supra note 88. 195. valeryia pratasava, unwanted pregnancies: outcomes for children, drexel univ. coll. med. (feb. 18, 2022), https://drexel.edu/medicine/academics/womens-health-andleadership/womens-health-education-program/whep-blog/unwanted-pregnancies-outcomes-forchildren/#:~:text=the%20stress%20associated%20with%20unintended,cognitive%2c%20moto r%20and%20emotional%20development [https://perma.cc/5ee3-wkdv]. 196. mostafavi, supra note 79. 197. u.s. food & drug admin., supra note 164. 198. mostafavi, supra note 79. 199. pratasava, supra note 195. 200. id. 201. id. 202. dan carden, indiana house approves plan to reduce unintended pregnancies, times n.w. ind. (feb. 20, 2024), https://www.nwitimes.com/news/state-regional/government-politics/ unintended-pregnancies-contraceptive-implant-medicaid/article_1e67d824-cf40-11ee-b688-0b9 497e5799b.html [https://perma.cc/np8c-adxl]. 203. id. https://perma.cc/np8c-adxl https://www.nwitimes.com/news/state-regional/government-politics https://perma.cc/5ee3-wkdv https://drexel.edu/medicine/academics/womens-health-and 2025] breaking barriers to birth control 211 reproductive health outcomes, publicly funded family planning services…in indiana helped save the federal and state government $140.3 million in 2010.” 204 these services show just how impactful increasing access to contraceptives could be for indiana. state regulators can increase consumer awareness of the new statute allowing pharmacists to prescribe contraceptives through partnerships with “community-based organizations, pharmacists associations, and other state agencies.”205 possible plans could involve ensuring that the public health department is providing information about how to access contraceptives through their website and providing specific informational materials. 206 pharmacies could display signage inside or outside their pharmacies displaying the new services, or pharmacists could even be given special buttons or badges to wear to promote the service. 207 local media networks could be contacted to publicize pharmacies that are providing access to contraceptives. 208 in fact, several states had local news outlets that spread the word about new legislation allowing pharmacists to prescribe contraceptives in their state by interviewing pharmacists and state regulators. 209 creating a “centralized registry of pharmacists certified to prescribe contraceptives” would also help women educate on which pharmacies and pharmacists can prescribe birth control. 210 for example, the utah department of health’s website provides a list of pharmacies where women can obtain contraceptives without a prescription. 211 b. why indiana code § 25-26-25-25 matters and what still needs to be done even though indiana women are living in an industrialized country in the twenty-first century, there is still a shortage of primary care physicians and obstetric care providers in many indiana counties. 212 of the 92 counties in indiana, 53 of those counties show a physician shortage... 213 23.9% of the counties in indiana are considered to be “maternity care deserts.” 214 a county is considered a maternity care desert if the county is “without a hospital or birth center offering obstetric care and without any obstetric providers.” 215 physician ————————————————————————————— 204. state facts about unintended pregnancy: indiana, guttmacher inst. 2 (2016) (available at https://www.guttmacher.org/sites/default/files/factsheet/in_18.pdf [https://perma.cc/ bae2-22m5]). 205. orris et. al., supra note 119, at 15. 206. id. at 16. 207. id. at 15. 208. id. 209. id. at 16. 210. id. at 17. 211. id.; see generally cities, utah gov. https://mihp.utah.gov/wp-content/uploads/ cities.pdf [https://perma.cc/9yb9-3ehd] (last visited mar. 10, 2024). 212. maternity care desert, supra note 191; see also charron, supra note 6. 213. charron, supra note 6. 214. maternity care desert, supra note 191. 215. id. https://perma.cc/9yb9-3ehd https://mihp.utah.gov/wp-content/uploads https://perma.cc https://www.guttmacher.org/sites/default/files/factsheet/in_18.pdf indiana health law review [vol. 22:187 212 shortages throughout the united states are also expected to increase because “the demand for physicians is growing faster than the supply of physicians.” 216 these physician shortages help explain why women may struggle to find access to medications, including contraceptives. in addition, indiana’s recent abortion ban further increases the importance of ensuring that women have access to birth control. by allowing pharmacists to prescribe birth control, it can help make up for physician shortages. physician offices typically close at 5 p.m. each day and are usually only open monday to friday. 217 pharmacies are typically open later in the evenings and are open on the weekends. 218 this would make it easier for women who have school or work to visit a pharmacist for their prescription. 219 allowing pharmacists to prescribe birth control would allow women to refill their birth control prescriptions more conveniently and efficiently. 220 indiana code § 16-34-2-1 went into effect on august 1, 2023, and makes abortion a criminal act unless “the abortion is necessary when reasonable medical judgment dictates that performing the abortion is necessary to prevent any serious health risk to the pregnant woman or to save the pregnant woman's life or the fetus is diagnosed with a lethal fetal anomaly.” 221 this law also prohibits abortion-inducing drugs from being “dispensed, prescribed, administered, or otherwise given to a pregnant woman after eight (8) weeks of postfertilization age.” 222 since women will not be legally able to obtain an abortion in indiana unless they meet the specific criteria, women that do not wish to become pregnant need to have greater access to contraceptives. in 2022, 9,529 abortions were performed and 32.83% of those abortions occurred past eight week of gestation, which ind. code § 16-34-2-1 now prohibits unless they fit the statute’s narrow qualifications. 223 ensuring women have access to contraceptives is now more important than ever so that women can prevent unwanted pregnancies. additionally, birth control may be prescribed for other medical conditions. birth control may be prescribed to treat: “primary dysmenorrhea; endometriosis; amenorrhea due to low weight, stress, or exercise; menstrual cramps; premenstrual syndrome; primary ovarian insufficiency, menorrhagia; acne; [and] polycystic ovary syndrome.”224 ————————————————————————————— 216. xiaoming zhang et al., physician workforce in the united states of america: forecasting nationwide shortages, 18 hum. res. for health. 1, 2 (2020). 217. see generally erin n. deja & joseph l. fink iii, pharmacists prescribing birth control: improving access and advancing the profession, 82 pharmacy times (nov. 16, 2016), https://www.pharmacytimes.com/view/pharmacists-prescribing-birth-control-improving-accessand-advancing-the-profession [https://perma.cc/wk78-jab8]. 218. id. 219. id. 220. id. 221. ind. code § 16-34-2-1(a)(1)(a) (2024). 222. id. § 1(a)(1)(e). 223. lindsay m. weaver et al., supra note 191, at 17; see ind. code § 16-34-2-1 (2024). 224. see bansode et al, supra note 2. https://perma.cc/wk78-jab8 https://www.pharmacytimes.com/view/pharmacists-prescribing-birth-control-improving-access 2025] breaking barriers to birth control 213 women may elect to start birth control to prevent pregnancies or to help with other medical conditions. it does not matter why a woman starts birth control; her contraceptive prescription is just as important as any other medication she may be prescribed. v. conclusion to conclude, indiana residents must have greater access to birth control because of the maternal deserts that exist within indiana. allowing pharmacists to prescribe birth control helps fill in the gap where women may lack access to providers. contraceptives can not only prevent unwanted pregnancies but can also help provide relief to other women’s health concerns. access to contraceptives in indiana is now more important than ever because indiana no longer allows abortions for women unless they meet certain statutory criteria. the vast number of negative side effects that come from unwanted pregnancies is another reason why women need to have contraceptives so they can have the capability to choose what happens to their bodies. to ensure that women have greater access to contraceptives, pharmacists first need to feel comfortable providing the services to women. by providing adequate training and resources for pharmacists, the number of pharmacists that offer these resources will increase. since this is another service that pharmacists would be adding to their already busy schedules, pharmacists need to be properly incentivized for their services. to do this, indiana needs special billing codes that pharmacists can use so they can be properly reimbursed. additionally, once the number of pharmacists willing to provide services increases, then the legislation needs to be publicized so residents can find pharmacists near them who could provide services. the indiana statute allowing pharmacists to prescribe birth control is a small step in the right direction in providing greater access to contraceptives to women, but for the statute is to make a true impact, there is still work that needs to be done. this is why indiana should ensure that there is a proper reimbursement plan in place for pharmacists to have an incentive to prescribe birth control. structure bookmarks reaking arriers to irth ontrolhy ccess to irth ontrol atters and hat till eeds to e one keeping your head on straight: protecting indiana youth athletes from traumatic brain injuries through "return-to­ play" legislation andrew w. breck* i.introduction ....................................................................................... 216 ii. medical background ....................................................................... 219 a. definition and symptoms of a concussion .............................. 219 b. grades ofconcussion .............................................................. 220 c. diagnosis and testingfor concussions .................................. 221 1. american academy of neurology ........................................ 221 2. impact testing ................................................................... 222 d. second impact syndrome ........................................................ 223 e. long-term health effects ......................................................... 224 ill. actions by state legislatures to protect youtii aniletes from traumatic brain injury ............................................................. 225 a. state of washington's "lystedt law" ...................................... 225 b. comparing the lystedt law with variations of return-to-play legislation e1jtlcted by other states ................... 226 1. uniform concussion guidelines and distribution of education materials ............................................................. 221 2. training programs ..................................... : .. ···•·· ................. 228 3. informed consent to play and submission of medical history ....................................................................... 229 4. immediate removal from play ............................................ 230 5. return-to-play requirements ............................................... 231 6. neuropsychological testing ................................................. 233 n. currentr.eturn-to-playguidelinesinindiana ...................... 233 v. analysis of indiana's current"r.eturn-to-play"law ........... 235 a. indiana's new law .................................................................. 235 1. uniform concussion and head injury guidelines ............... 236 2. signed information sheet and form .................................... 236 3. immediate removal from play ............................................. 236 4. return-to-play protocol: written clearance from a licensed health care provider ............................................... 237 b. critique of indiana's proposed legislation ............................. 231 1. uniform concussion and brain injury guidelines .............. 238 2. mandatory concussion and head injury training .............. 238 3. personal brain injury information sheet and form ............ 240 4. impacttesting ................................................................... 240 5. return-to-play protocol: requirements of the licensed health care provider, gradual return-to-play, and a 216 indiana health law review [vol. 9:1 mandatory waiting period ......................... ' ................ .-............ 241 vi. conclusion •.••••••••••.••••••••••••••••••••••.•••••••••••••.•••.•••••..•.•.•••••..••••• ~ ..•.•....• 244 i. introduction justin joyce, an indianapolis-area football player, took a knee to his temple in the first game of the 2010 high school football season.1 joyce felt that something was not quite right, but.he continued to play in the game.2 although joyce finished the game, he reported feeling ill after sustaining the jarring blow to his head? after taking a minor hit in a game the follow­ ing week, joyce lost his balance and was removed from competition.4 joyce was diagnosed with a concussion the next day.5 a "concussion is an invisible injury in a lot of cases, [and] therefore there is no awareness of the injury.'o6 although concussions may be invisi­ ble to the naked eye, a recent spike in traumatic brain injuries suffered by youth athletes participating in amateur sports has cast a national spotlight on the issue. from 2006 to 2009, a study conducted by the national center for catastrophic sport injury research at the university of north carolina reported that thirty-two high school and youth athletes suffered permanent brain damage and nine died from bead injuries. 7 even more alarming, the rate of head injuries in youth athletes reported by the center nearly doubled the total from the. previous four years. 8 the emerging national initiative to combat traumatic brain injuries sustained by youth athletes gained steam following an incident in the state of washington. in october 2006, zackery lystedt, a youth athlete from tacoma, washington, complained of pain in his bead after making a routine tackle during a junior high school football game. 9 after minimal inquiry and no medical tests, coaches later allowed lystedt to return to competition • j.d. candidate, 2012, indiana university robert h. mckinney school of law; b.a., 2006, depauw university. 1. nat newell, the hardest hit, indianapous star, oct. 1, 2010, § localmetro & state, at at. 2. /d. 3. /d. 4. /d. 5. !d. 6. melissa healy, sideline athletes with concussions, group says, cm. trm., nov. 2, 2010, §news, at 13 (quoting dr. jeffi'ey kutcher from the neurosport program at the university of michigan). 7. newell, supra note 1, at al. 8. /d. 9. the zack lystedt law: preventing brain injuries in children, patient power (may 14, 2009), http:/lwww.p!jtientpower.info/programltbe-uck-lystedt-law-preventing­ brain-injuries-in-cbildrenltranscript/2. 2012] "return-to-play" legislation 217 after halftime. 10 unbeknownst to anyone, lystedt had suffered a concus­ sion, and toward the end of the game he collapsed into a coma.11 emergen­ cy surgery on both sides of lystedt's brain saved his life, but he suffered considerably following the injury.12 lystedt was unable to speak for nine months and could not move his limbs for thirteen months.13 although he has since regained these functions,.lystedt remains confined to a wheel­ chair, suffering severe cognitive defects.14 more than three years after the injury, lystedt continues to undergo forty hours.oftherapy every week in a determined effort to rehabilitate.15 in the years following the incident, the lystedt family along with assistance from the brain injury association of washington successfully lobbied for passage of the lystedt law.16 the lystedt law is the nation's first state statute requiring adherence to a strict protocol in allowing youth athletes to return-to-play following an apparent brain injury. 17 unfortunately, both the joyce and lystedt stories are not unique. youth athletes across the nation are suffering concussions with increased frequency in recent years. 18 a survey conducted during the 2008-2009 sea­ son by the indianapolis-based national federation of state high school associations (''nfhs")19 estimates that 140,000 high school athletes, or roughly 1.8% of the total participants, suffer concussions every year.20 the issue is not just limited to football. according to the nfhs study, ice hockey and women's lacrosse rank second and third, respectively, in con­ cussion rates.21 the american academy of neurology issued a position statement in october 2010 supporting implementation of a general policy aimed at pro­ tecting youth athletes from suffering serious brain injuries.22 according to 10. /d. 11. scott sandsberry, gray matter: attitudes toward brain injuries changing with more knowledge, yakima iierald-repubuc (wash.), oct. 29, 2010, http:// sportsya­ kima.com/2010/10/gray-matter-attitudes-toward-brain-injuries-changing-with-more­ knowledge/. 12. the zack lystedt law: preventing brain injuries in children, supra note 9. 13. sandsberry, supra note 11. 14. the zack lystedt law: preventing brain injuries in children, supra note 9~ 15. house call with dr. sanjay gupta: concussion crisis in football (cnn television broadcast nov. 27, 2010). 16. megan foreman, sidelined for sqfety, st. legisla1ur.es, june 1, 2010, at 28. 17. /d. 18. concussion, medlineplus, http://www .nlm.nih.gov/medlineplus/concussion.html (last visited sept. 24, 2011 ). 19. see generally about nfhs, national federation of state high school associations, http://www.nfhs.org/activity3.aspx?id=3260 (last visited sept. 24, 2011) (describing the function ofnfhs as "set[ting] directions for the future by building aware­ ness and support, improving the participation experience, establishing consistent standards and rules for competition, and helping those who oversee high school sports and activities"). 20. newell, supra note 1, at al. 21. id. 22. position statement on sports concussion, am. acad. of neurology (oct. 2010), 218 indiana health law review [vol. 9:1 the group, the driving force behind advocating for a safer concussion and head injury policy is that sports now rank second only to motor vehicle ac­ cidents as a leading cause of traumatic brain injuries in people aged fifteen to twenty-four.23 congress has recently considered at least two bills that would imple­ ment national guidelines for identifying and managing concussions in youth athletes.24 however, federal legislation has yet to be enacted, and there ap­ pears to be a lack of urgency in passing a federal mandate. in fact, the con­ cussion treatment and care tools act ("contact act") unanimously passed the house of representatives in september 2010, but the senate "didn't have much time to finish giving consideration" to the bill before the congressional session concluded, thus allowing the proposed legislation to expire. 25 in the absence of federal regulation, it is critical to have state statutory guidelines regulating a youth athlete's return to the playing field following an apparent head injury. several states have enacted specific return-to-play legislation based on washington state's lystedt law; indiana passed its new law in may 2011, which requires compliance by july 1, 2012.26 return-to-play legislation is intended to protect youth athletes from the potential long-term or fatal health effects that accompany head injuries. it takes young people longer to heal from concussions than adults.z7 "kids' bodies are still growing; so are their brains. but while they rebound from sprains and strains more easily than creaky adults, kids get hurt worse by blows to the head and take longer to recover."28 in fact, an injury that may take an adult's brain five days to heal could require a younger person's brain ten days or even longer to fully recover.29 furthermore, while youth athletes' bodies are growing, they are not in the physical condition to take hits to the head as readily as older, more developed athletes. according to chris nowinski, president of the nonprofit sports legacy institute, "high school players generally have weaker necks than college or professional players . . . which causes their heads to absorb a greater amount of force when hit. "30 http://www.aan.com/ globals/axon/assets/7913.pdf. 23. !d. 24. darla carter, watch your head: concussions are serious, common injuries don't ignore them, courier-journal (louisville, ky.), sept. 30,2010, at dl. 25. jackie friedman, contact act creators seek national guidelines, star-ledger (newark, n.j.), feb. 5, 2011, § sports, at 26 (quoting rep. bill pascrell, a sponsor of the contact act). 26. see ind. code§§ 20-34-7-1 to -5 (2011). 27. foreman, supra note 16, at 28. 28. editorial, adults must use their heads in handling young athletes' concussions, fort worth star-telegram, sept. 6, 2010, available at http://www.star-telegram.com/2010/09/06/2448068/adults-must-use-their-heads-in.html. 29. foreman, supra note 16, at 28. 30. chris hine, going to max protect: ihsa has new concussion rule, but some critics demand more, cm. trib., aug. 26,2010, §chicago sports, at 6. 2012] "return-to-play" legislation 219 part ii of this note will discuss concussions from a medical perspec­ tive including a definition and common symptoms of concussion, an expla­ nation of the different grades of concussion, diagnosis and current testing methods for concussions, the dangers of second impact syndrome, and the long-term health effects associated with traumatic brain injuries. part iii will discuss the features of washington state's lystedt law, the first re­ turn-to-play statute passed by any state legislature, and will compare it with variations of return-to-play legislation subsequently enacted by other state legislatures. part n will discuss indiana's current concussion protocol along with an analysis of the return-to-play legislation recently passed by the indiana legislature. finally, part v of this note will critique indiana's new return-to-play law and set forth recommendations for improvement based on observations of the various permutations of the lystedt law passed by other state legislatures. ii. medical background a. definition and symptoms of a concussion there is no universal agreement among scientists and medical practi­ tioners on the precise definition of a concussion.31 generally, though, a concussion can be defined as "a complex pathophysiological process affect­ ing the brain, induced by traumatic biomechanical forces."32 the centers for disease control and prevention ("cdc") categorizes a concussion as a type of traumatic brain injury ("tbi").33 in fact, "[t]he term 'concussion' is often used in the medical literature as a synonym for a mild traumatic brain injury."34 a concussion may be caused by several factors including "a di­ rect blow to the head, face, neck, or elsewhere on the body with an 'impul­ sive' force transmitted to the head."35 however, it does not take a complete loss of consciousness to suffer a concussion?6 the cdc categorizes the symptoms of concussions into four main 31. robert c. cantu, posttraumatic retrograde and anterograde amnesia: patho­ physiology and implications in grading and safe return-to-play, 36 j. athletic training 244, 244 (200 1 ), available at http://www.ncbi.nlm.nih.gov/pmc/articles/pmc 155413/. 32. paul mccrory et al., consensus statement on concussion in sport: the 3rd inter­ national conference on concussion in sport held in zurich, november 2008, 44 j. athletic training 434, 435 (2009), available at http://bjsm.bmj.com/content/43/suppl_l/ i76.full.pdf. 33. concussion and mild tbi, ctrs. for disease control & prevention, http://www.cdc.gov/concussion/index.html (last updated aug. 25, 201 0). 34. davids. kushner, concussion in sports: minimizing the risk for complications, 64 am. fam. physician 1007, 1008 (2001), available at http://www.aafp.org/afp/2001/0915/ pl007.html. 35. paul mccrory et al., supra note 32, at 435. 36. editorial, adults must use their heads in handling young athletes' concussions, supra note 28. 220 indiana health law review [vol. 9:1 categories: thinking and remembering; physical; emotional and mood; and sleep disturbance.37 an individual suffering from a concussion may have difficulty thinking clearly, concentrating, remembering new information, or may feel slowed down. 38 physical symptoms include headache, nausea or vomiting, balance problems, dizziness, fuzzy or blurry vision, sensitivity to noise or light, or feeling tired and lethargic.39 some patients with concus­ sions may also complain of a ringing in their ears.40 in more severe cases following a traull'latic brain injury, an individual may lose consciousness or suffer the effects of amnesia. 41 furthermore, an individual may exhibit signs of emotional distress or behavioral changes and become irritable, sad, nervous, anxious, or more emotional than normal.42 finally, an individual with a concussion may 'suffer disturbances in sleeping patterns including sleeping more than usual, sleepingjess than usual, or experiencing difficul­ ty in falling asleep;43 ·· some symptoms of a concussion may appear immediately after im­ pact, while other symptoms may not be idnnediately ascertainable until days, or potentially even months, after the injury.44 in the minutes and days following a concussive brain injury, brain cells that are not irreversibly de­ stroyed may remain alive but in a distinctly more vulnerable state.45 b. grades of concussion as with the definition of a concussion, there is no universal agreement among scientists and medical practitioners on the grading of concussions.46 in the field of sports medicine, however, the value of grading scales for as­ sessing the severity of ooneussive brain injuries is recognized by medical practitioners.47 medical experts at the american academy of netirology categorize concussions into three levels: gradel, grade 2, and grade 3.48 a grade 1 concussion is characterized by transient confusion, no loss of consciousness, and concussion symptoms or mental status abnormalities 37 . . concussion, ctrs. for disease control & prevention, http://www.cdc.gov/ concussion!signs_symptoms.btml (last updated mar. 8, 2010). 38. /d. 39. /d. 40. concussion, medlinepws, supra note 18. 41. paul mccrory et al., supra note 32, at 435. 42. concussion, ctrs. for disease control & prevention, supra note 37. 43. /d. 44. /d. 45. cantu, supra note 31, at 244. 46. /d. 47. see am. acad. of neurology, practice parameter: the management of concussion in sports 2 (1997), http://www.aan.com/professionals/practice/guidelines/pda/ concussion_ sports. pdf. 48. /d. at 2-3. 2012] "return-to-play" legislation 221 that resolve in less than fifteen minutes.49 this grade of concussion is the most common yet most difficult to recognize because an individual suffers only momentary confusion. 50 a youth athlete may momentarily be dazed but quickly respond to questioning by coaches or evaluating medical per­ sonnel. youth athletes commonly report feeling "dinged" or getting their ''bell rung."51 a grade 2 concussion is characterized by transient confusion and no loss of consciousness, but concussion symptoms or mental status abnormal­ ities on examination last longer than fifteen minutes. 52 a persistent grade 2 concussion lasting longer than one hour is extremely dangerous and war­ rants immediate medical observation. 53 a youth athlete suffering from a grade 2 concussion may exhibit poor concentration or post·traumatic am­ nesia over an extended period of time. 54 a grade 3 concussion involves any loss of consciousness suffered by a youth athlete-either brief (lasting only a few seconds) or more prolonged (lasting several minutes). ss a grade 3 concussion is the easiest to recognize and warrants immediate medical attention. 56 c. diagnosis and testing for concussions initially, diagnosis of the grade of a concussion is difficult. it depends partly on information from the injured individual, who may not be medical­ ly trained to identify and communicate critical information regarding the effects of the injury. robert cantu, a leading expert on concussive injuries, stated that a "[ c ]oncussion is often referred to as the silent epidemic .... it's not always easy to look at somebody and see if they've suffered a con­ cussion."57 1. american academy of neurology the american academy of neurology provides a breakdown for on· site evaluations of concussions, which includes mental status testing, exter­ nal provocative testing, and neurological testing. 58 the mental status read· 49. !d. 50. !d. at3. 51. !d. 52. id 53. id 54. id 55. id 56. !d. 57. jack mccluskey, tackling a silent epidemic: new law aims at curbing sport­ related concussions, but is it enough?, espnbosron.com (aug. 24, 2010 3:37 pm), http://sports.espn.go.com/bostonlnews/story?id=5489974. 58. see am. acad. of neurology, supra note 47 at 3. 222 indiana heal til law review [vol. 9:1 ing assesses: (1) orientation, by asking an individual to recite the time, place, person, and situation; (2) concentration, by asking an individual to count backwards or recite a sequence of items in reverse order; and (3) short-term memory, by asking about recent events, either regarding the ath­ letic competition where the injury was sustained or other newsworthy events. 59 the external provocative test requires the individual to perform an athletic maneuver (e.g., push-ups, sprinting, sit-ups, or knee bends) in order to evaluate any differences in performance from before the injury.60 if the youth athlete exhibits abnormal signs, such as headaches, dizziness, nausea, blurred vision, or emotional aberrations, then the sideline medical evalua­ tors will classify the injury as a concussive event 61 finally, the neurological testing for a concussion injury includes ex­ amining an individual's: (1) pupils for symmetry and reaction time; (2) co­ ordination, through a finger-nose-finger, in tandem with walking, test; and (3) sensation, through a finger-nose, eyes-closed test.62 2. impact testing a more popular concussion diagnostic tool is called the immediate post-concussion assessment and cognitive testing ("impact").63 de­ veloped in the early 1990's, impact "is the first, most-widely used, and most scientifically validated computerized concussion evaluation system. "64 impact is a twenty-minute evaluation that measures an individual's per­ formance across a number of physical, mental, and neurological criteria including attention span, working memory, sustained and selective attention time, response variability, non-verbal problem solving, and reaction time.65 the scores of an individual taken post-injury are compared with baseline testing performed on the athlete prior to the injury in order to detect abnor­ malities and whether a concussion has occurred.66 a popular feature of im­ pact is that it can be conducted by anyone trained to administer the baseline testing·including an athletic trainer, school nurse, athletic director, team coach, or team doctor.67 imp act is administered on a computer and monitored by a qualified 59. seeid 60. seeid. 61. see id. 62. seeid 63. about impact: overview and features of the impact test, impac'itest.com, http:/ /impacttest.com/aboutlbackgrowtd (last visited july 9, 2011 ). 64. id 65. id 66. id. 67. id 2012] "return-to-play" legislation 223 professional trained on the software.68 the test is broken down into five separate sections, each compiling a variety of medical data.69 section 1 re­ quires individuals to insert basic demographic information and answer a brief health history questionnaire.70 section 2 then asks questions pertain­ ing to the current concussion symptoms being experienced.71 specifically, this section asks about the date of the most recent concussion, number of hours slept afterward, and current medications taken after the injury. 72 ad­ ditionally, this section requires individuals to rate the severity of twenty­ two concussion symptoms, which ultimately factor into the individual's final score.73 section 3 is a neurocognitive test and is split into six separate modules: (1) word discrimination; (2) design memory; (3) "x's and o's," a visual recognition test gauging reaction times to illuminated on-screen ob­ jects; (4) symbol matching; (5) color matching; and (6) a three-letter memory task. 74 then, section 4 requires a more detailed description of the concussive event, including details on loss of consciousness, a description of any mouthguard or helmet worn at the time, and the point of contact.75 lastly, section 5 presents the graphical display of data showing and ex­ plaining the individual's overall impact results.76 using the results from the six modules in section 3 of the test, this section presents a composite of the athlete's final scores relative to verbal memory, visual memory, reaction time, and impulse control. 77 the final cumulative score then can be used to identify a concussed individual suffering from the effects of a traumatic brain injury from a non-injured individual. 78 d. second impact syndrome a series of repeated concussions over a short period of time may lead to a serious condition commonly referred to as second impact syndrome 68. /d. 69. id. 70. about impact: test featuresquestionnaire, impacti'est.com, http://impact test.com/aboutltest_features/questionaire (last visited aug. l 0, 2011 ). 71. about impact: test features current symptoms & condition, impact test.com, http://impacttest.com/aboutltest _features/current_ symptoms (last visited aug. l 0, 2011). 72. /d. 73. /d. 74. about impact: test featuresneurocognitive test, impacttest.com, http:// impacttest.com/about/test_features/neurocognitive _test (last visited aug. 10, 2011 ). 75. about impact: test features description of the concussion injury, imp acttest.com, http://impacttest.com/index.php/aboutltest _features/injury_ description (last visited aug. 10, 2011). 76. about impact: test featuresgraphic display of data, impacttest.com, http://impacttest.com/index.php/about!test_featureslgraphic _display (last visited aug. l 0, 2011). 77. /d. 78. /d. 224 indiana health law review [vol. 9:1 ("sis").79 sis develops when an athlete suffers a second head injury before symptoms have fully subsided from. the first brain trauma. 80 a second im­ pact that causes sis need only be a minor blow and may not even be direct­ ly to the head, but the blow will cause the individual's head to snap and "impart accelerative forces to the brain.'.s1 sis starts with typical post­ concussion symptoms and the individual will generally appear stunned and exhibit symptoms of a grade 1 concussion. 82 within fifteen seconds to several minutes of the second impact, an individual will collapse with rap­ idly dilating pupils, loss of eye movement, and respiratory failure. 83 studies have shown that the severity and duration of functional im­ pairment may be significantly'increased with repeated concussions.84 rob­ ert cantu stated that "[ o ]nee a player has incurred an initial cerebral concussion, his or her chances of incurring a second one are 3 to 6 times greater than for an athlete who has never sustained a concussion. "85 e. long-term health effects long-term outcomes for individuals· suffering concussions and other brain injuries include deficits in memory, reasoning, sensation, language, and emotion. 86 a traumatic brain injury {''tbf') such as a concussion may also cause significant long-term h~th effects including epilepsy and an increased risk for alzheimer's disease, parkinson's disease, and other brain disorders. 87 repeated, mild tbis occurring over an extended period of time, such as within months or years, can cause cumulative neurological and cognitive defects. 88 furthermore, repeated, mild tbis occurring within a short period of time, such as within hours, days, or weeks, can be cata­ strophic or even fatal. 89 79. kushner, supra note 34, at 1008. 80. robert c. cantu & robert voy, second impact syndrome a risk in any contact sport, 23 physician & sportsmedicine 27 (1995). 81. !d. 82. !d. 83. !d. 84. cantu, supra note 31, at 246. 85. id 86. traumatic brain injury: long-term outcomes, ctrs. for disease con'irol & prevention, http:l/www.cdc.gov/fraumaticbtainlnjury/outcomes.html (last visited mar. 8, 2010). 87. id 88. !d. 89. id. 2012] "return-to-play" legislation 225 iii. actions by state legislatures to protect youth athletes from traumatic brain injury a. state ofwashington's "lystedt law" the state legislature of washington passed the zackery lystedt law ("lystedt law") in may 2009.90 it was the first state law to implement statutory requirements for youth athletes suffering from concussions.91 the statute sets forth four key requirements: (1) development of uniform con­ cussion guidelines and distribution of educational materials regarding brain injuries; (2) mandatory consent from parents for participation in youth ath­ letics; (3) immediate removal of the youth athlete from competition after suffering an apparent brain injury; and (4) mandatory compliance with re­ turn-to-play protocol before allowing the youth athlete to return to athletic competition.92 first, each school district's board of directors must work in concert with washington's state interscholastic activities associations to develop guidelines on pertinent information regarding concussions.93 then, the col­ lective information must be compiled and communicated to coaches, youth athletes, and parents or guardians of youth athletes. 94 the educational system established after passage of the lystedt law allowed coaches to receive concussion training from online rules clinics, which were offered free of charge from the washington interscholastic ac­ tivities association ("wiaa") website.95 while coaches are not required to pass an official state examination or obtain state certification as part of the education process, they are responsible for transmitting pertinent infor­ mation to their youth athletes.96 furthermore, each school district is indi­ vidually responsible for adopting concussion management policies and ensuring that all coaches receive proper education on the nature, risks, signs, and symptoms of brain injuries prior to the coach's first practice or competition. 97 second, on an annual basis, each youth athlete and a parent or guardi­ an must jointly sign and return a concussion and head injury information 90. foreman, supra note 16, at 28. 91. /d. 92. see wash. rev. code ann.§§ 28a.600.190(2)(4) (west20ll). 93. wash. rev. code ann.§ 28a.600.190(2) (west 2011). 94. /d. 95. publications: concussion management guidelines coaching resources, wash. interscholastic activities ass'n, http://www.wiaa.com/subcontent.aspx?secid=624 (last visited sept. 24, 2011). 96. /d.. 97. publications: concussion management guidelines school resources, wash. interscholastic activities ass'n, http://www.wiaa.com/subcontent.aspx?secid=627 (last visited aug. 12, 2011). 226 indiana realm law review [vol. 9:1 sheet circulated by the school district before the youth athlete is allowed to participate in any sporting practice or competition.98 if a youth athlete is suspected of sustaining a concussion or head injury in a practice or game, the youth athlete must be immediately removed from the practice or game at that time.99 moreover, a youth athlete may not be allowed to return-to­ play until both of the following criteria are met: the youth athlete is evaluat­ ed by a licensed health care provider trained in the evaluation and manage­ ment of concussions, and the youth athlete receives written clearance to return to play from that licensed health care provider.100 the statute allows a volunteer to act as the health care provider for a school district responsible for both the initial concussion evaluation and management, as well as for the subsequent written authorization for the youth athlete to return to com­ petition.101 furthermore, following passage of the lystedt law, the wiaa specif­ ically identified which licensed health care providers could conduct the re­ turn-to-play protocol: medical doctors, doctors of osteopathy, advanced registered nurse practitioners, physician assistants, and licensed certified athletic trainers. 102 the wiaa is currently researching other medical pro­ viders who may qualify for return-to-play authorization and will communi­ cate any changes directly to all schools in the state.103 b. comparing the lystedt law with variations of return-to-play legisla­ tion enacted by other states eight other states have since passed specific return-to-play legislation for youth athletics modeled in some part after washington's lystedt law including: oregon, oklahoma, virginia, new mexico, connecticut, rhode island, idaho, and new jersey. texas previously enacted sport safety laws in 2007 before passage of the lystedt law;104 however, its requirements are more lenient than the state statutes modeled after the lystedt law, focusing only on annual head injury training for coaches and athletic trainers and providing no explicit return-to-play protocol.105 98. wash.rev.codeann. § 28a.600.190(2)(west2011). 99. wash. rev. code ann.§ 28a.600.190(3) (west 2011). 100. wash. rev. code ann.§ 28a.600.190(4) (west 2011). 101. id. 102. publications: concussion management guidelines health care providers, wash. interscholastic activities ass'n, http://www.wiaa.com/subcontent.aspx?secid= 628 (last visited sept. 24, 2011 ). 103. id. 104. editorial, adults must use their heads in handling young athletes' concussions, supra note 28. 105. see tex. eouc. code ann. § 33.202 (west 2011 ). 2012] "retijrn-to-play" legislation 227 1. uniform concussion guidelines and distribution of education ma­ terials seven states require uniform concussion guidelines to be developed and implemented by local school districts; however, the states differ on the specific collaborative efforts needed to develop the guidelines. in washing­ ton106 and oklahoma,107 the local school districts work in concert with the states' respective youth interscholastic athletic activities associations to de­ velop concussion guidelines. new mexico requires the state's activities association and local school districts to develop the guidelines and training programs as well as collaborate with the state's brain injury advisory coun­ cil. los in contrast, other state statutes require no involvement of local school districts in the guideline development process. for example, the virginia board of education is the sole entity charged with developing concussion guidelines and distributing such guidelines to the local school districts in a top-down directive approach. 109 in contrast, rhode island's statute requires both the state's department of education and department of health to work jointly with the state's interscholastic athletic association to develop the guidelines on concussions and other head injuries. 110 idaho also requires collaboration between the state's board of education and the state's high school athletic association.111 idaho provides the most lenient standard and only requires the brain injury guidelines and other pertinent educational forms to be posted and easily retrievable on the state's board of education website;112 idaho does not require actual direct distribution of the material to local school districts.113 finally, new jersey requires its commissioner of education to devel­ op a model policy on sports-related concussion guidelines.114 this model policy, along with policies established by other organizations specializing in the prevention and treatment of sports-related concussions, 115 must be reviewed by each school district in developing an individualized written 106. wash. r:ev. code ann.§ 28a.600.190(2) (west 2011). 107. okla. stat. ann. tit. 70, § 24-155(a) (west 2011). 108. n.m. stat. a."<n. § 22-13-31(0) (west 2011). 109. va. code ann.§ 22.1-271.5(a)(west 2011). llo. r.i. gen. laws ann.§ 16-9l-3(a)(west2011). 111. idaho code ann. § 33-1625{1) (west 2011 ). 112. idaho code ann.§ 33-1625(2)(west 2011). 113. see id. 114. n.j. stat. ann.§ 18a:40-41.3(b) (west 2011). 115. n.j. stat. ann. § 18a:40-41.3(a) (west 2011) (listing the various organi7.ational policies to consider as "the new jersey state interscholastic athletic association, the na­ tional collegiate athletic association, and the recommendations made by the brain injury association of new jersey concussion in sports steering committee, [and] the athletic trainers' society ofnew jersey"). 228 indiana health law review [vol. 9:1 policy for that district regarding head injuries sustained by youth athletes.116 further, in an effort to ensure availability of the most up-to-date infor­ mation, each school district's policy must be annually reviewed and updat­ ed as necessary. 117 the current oregon and connecticut statutes do not require develop­ ment of uniform guidelines for concussion management, but they do require development of some form of standardized concussion training. oregon charges the state's board of education with establishing the appropriate head injury training requirements along with implementing a timeline for com­ pletion of this training prior to the start of each athletic season. 118 connect­ icut requires the training guidelines to be developed by the state's board of education in conjunction with the state's intramural and interscholastic ac­ tivities association, an appropriate organization representing licensed athlet­ ic trainers, and an appropriate organization representing county medical associations. 119 2. training programs several states currently require some form of organized concussion training program. however, the states differ regarding the type of training required, who must participate, and the frequency of training. oregon's statute is the least stringent ·and requires only coaches to receive annual training on the recognition of concussion symptoms.120 the oregon statute does not otherwise require any education or organized training program for other school officials, parents or guardians of youth athletes, or the youth athletes themselves. 121 connecticut also requires only coaches to complete initial training, but imposes stricter requirements by requiring the coach to review training materials annually and to complete a refresher course every five years.122 new mexico requires each coach participating in school athletic activ­ ities to receive training on the nature and risk of brain injury, recognition of symptoms of brain injury, understanding when it is critical to contact medi­ cal professionals, and the importance of following medical direction from professionals.123 however, the new mexico statute does not impose a fre­ quency requirement for the training.124 the new mexico statute goes fur116. /d. 117. id. 118. or. rev. stat. ann.§ 336.485(2) (west 2011). 119. conn. gen. stat. ann.§ 10-149b(bx1) (west 2011). 120. or. rev. stat. ann. § 336.485(2xa) (west 2011 ). 121. see id. 122. conn. gen. stat. ann.§§ 10-149b(ax2)-(3) (west 2011). 123. n.m. stat. ann.§§ 22-13-31(c)(d)(1) (west 2011). 124. see n.m. stat. ann. § 22-13-31 (west 2011). 2012] "return-to-play" legislation 229 ther than the oregon statute by mandating that the state's athletic activities association develop and distribute educational materials on brain injuries to a wider cross-section of individuals, including coaches, student athletes, and parents or guardians of student athletes.125 rhode island requires schools to make use of specified training mate­ rials made available by the centers for disease control and prevention ("cdc").126 rhode island's department of education must post the train­ ing materials on its website, making the information. readily available to each school district.127 additionally, the rhode island statute requires all coaches and volunteers involved in youth athletic activities subject to the state's athletic association to complete a training course on concussions and traumatic brain injuries.128 rhode island requires the coaches and volun­ teers to complete a refresher course on an annual basis thereafter.129 new jersey's statute mandates that the state's department of education develop and implement an interscholastic athletic head injury safety. train­ ing program.130 the statute requires school physicians, any coach of a pub­ lic or nonpublic school interscholastic sport, and all athletic trainers of public and nonpublic school interscholastic programs to complete . such training.131 furthermore, the new jersey department of education is re­ quired to update the training program. when necessary to ensure the appro­ priate education is provided to the proper individuals.132 the texas statute requires coaches, trainers, and sponsors for extra­ curricular athletic activities to satisfactorily complete a safety-training pro­ gram, 133 which includes certification requirements of all participants from the american red cross, american heart association, or a similar organi­ zation under the state's youth interscholastic athletic associatimi!34 infor­ mation that must be presented within the training and later provided to student athletes includes recognizing symptoms of catastrophic injuries specifically related to the head and neck, concussions, and second impact syndrome. 135 3. informed consent to play and submission of medical history a majority of states require some form of informed consent or sub125. n.m. stat. ann.§ 22-13-31(dx2) (west 2011). 126. r.i. gen. laws ann.§ 16-91-3(b)(west 2011). 127. id. 128. /d. 129. id. 130. n.j. stat. ann.§ 18a:40-412(a)(west2011). 131. !d. 132. n.j. stat. ann.§ 18a:40-412(b) (west2011). 133. tex. eouc. code ann.§ 33.202(bx1)(west 2011). 134. tex. eouc. code ann.§ 33.202(cxl)(west20ll). 135. tex. eouc. code ann.§§ 33.20i(cx2)(d),(dxl)(west2011). 230 indiana heal til law review [vol. 9:1 mission of medical history prior to allowing a youth athlete to participate in sporting activities. currently, the return-to-play laws require only a youth athlete and the athlete's parent or guardian to annually sign a generic head or brain injury information form developed by either the state or the local school district. five states require signature of these basic informational forms: washington,136 virginia, 137 oklahoma, 138 new mexico, 139 and new jersey.140 rhode island's statute is even more stringent, requiring the gen­ eral concussion and brain injury information form to be signed and returned prior to the start of every sport season, which requires a multi-sport athlete and their parent or guardian to sign and return the form before the start of each separate sport season.141 specifically, these general concussion and brain injury infortnation forms communicate the symptoms, risks, and long-term health effects rela­ tive to head injuries and are required to be signed and returned to the school or coaches prior to the athletic season to document receipt of the infor­ mation. therefore, none of the current return-to-play statutes mandate that a youth athlete provide any personal head injury or concussion history in­ formation either to the coaches or to any school district officials prior to participation in athletic competition. 4. immediate removal from play a critical piece of all return-to-play legislation involves the immediate removal of a youth athlete suffering from an apparent head injury from the field of play. several states currently require an athlete to be immediately removed from practice or competition if they appear to have suffered a head injury or concussion. these states include washington,142 oregon,143 vir­ ginia,144 oklahoma,'45 new mexico,'46 connecticut,147 new jersey,'48 and rhode island.149 these eight states take a more stringent approach to youth athlete head injuries, in that a youth athlete will be immediately removed from play after a head injury, even if the athlete does not suffer uncon­ sciousness. by contrast, the current idaho laws do not address or require 136. wash. rev. code ann. § 28a600.190(2) (west 2011 ). 137. va. code ann. § 22.1-271.5(bx1) (west 2011). 138. okla. stat. ann. tit. 70, § 24-155(a) (west 2011). 139. n.m. stat. ann.§ 22-13-31(e) (west 2011). 140. n.j. stat. ann.§ 18a:40-41.2(c) (west 2011). 141. r.i.gen.lawsann. § 16-91-3(c)(west2011). 142. wash. rev. code ann.§ 28a.600.190(3) (west 2011). 143. or.. rev. stat. ann.§ 336.485(3xa) (west 2011). 144. va. code ann.§ 22.1-271.5(bx2)(west 2011). 145. okla. stat. ann. tit. 70, § 24-155(b) (west 2011). 146. n.m. stat. ann.§§ 22-13-31(ax1)-(2) (west 2011). 147. conn. gen. stat. ann.§§ 10-149c(ax1xa)-(b) (west2011). 148. n.j. stat. ann.§ 18a:40-41.4 (west 2011). 149. r.i. gen. laws ann.§ 16-91-3(d)(west 2011). 2012] ''return-to-play" legislation 231 immediate removal of a youth athlete when he or she appears to have suf­ fered either a head injury or concussion.150 5. return-to-play requirements several states require a youth athlete who appears to have suffered a head injury or concussion to be evaluated before returning to athletic prac­ tice or competition. the rhode island statute e~bits the least restrictive language by requiring an evaluation from a licensed physician and written clearance before the youth athlete may return to play.151 the new mexico statute is virtually the same and mandates medical clearance by a licensed health care provider.152 oregon's statutory language is similarly broad, re­ quiring the youth athlete to be evaluated and medically released by a health care professiona1.153 these three statutes do not explicitly mandate that the licensed medical personnel who are evaluating and medically clearing the youth athlete have any specific training in concussion or head injury man­ agement. other state statutes are more strict and require youth athletes suspect­ ed of sustaining a head injury to be evaluated by a licensed medical health care provider specifically trained in concussion evaluation and management and receive written clearance from that licensed health care provider prior to returning to competition. these states include washington,154 oklaho­ ma, 155 connecticut, 156 and new jersey.157 these additional requirements ensure that the medical evaluator has specific training in concussion man­ agement and provide a safeguard to ensuring appropriate medical decision­ making. two states provide even more demanding requirements, such as ex­ plicitly identifying the medical licenses appropriate to evaluate and manage concussions of youth athletes under return-to-play protocols. new mexi­ co's statute clearly mandates that the health care professional conducting the return-to-play protocol meet one of the following state licensing re­ quirements: practicing physician or physician assistant licensed under the state's medical practice ·act, practicing osteopathic physician, practicing certified nurse practitioner, practicing osteopathic physician's assistant, practicing psychologist, or practicing athletic trainer.158 connecticut's stat­ ute also mandates that the health care professional meet one of the follow150. see idaho code ann.§ 33-1625 (west 2011). 151. r.i. gen. laws ann.§ 16-91-3(e)(west 2011). 152. n.m. stat. ann.§ 22-13-31(b)(2) (west 2011). 153. or. rev. stat. ann.§ 336.485(3)(b)(b) (west 2011). 154. wash. rev. code ann.§ 28a.600.190(4)(west2011). 155. okla. stat. ann. tit. 70, § 24-155(c) (west 2011). 156. conn. gen. stat. ann.§§ 10-149c(a)(2), (a)(3)(b) (west 201 1). 157. n.j. stat. ann.§ 18a:40-41.4 (west 2011). 158. n.m. stat. ann. § 22-13-31(f)(5) (west 2011). 232 indiana health law review [vol. 9:1 ing state statutory licensing requirements: licensed physician, licensed phy­ sician assistant, licensed advanced practice registered nurse, or a licensed athletic trainer.159 virginia's return-to-play law requires a youth athlete who appears to have suffered a head injury or concussion to be evaluated by a licensed health care provider and receive written clearance from that health care provider prior to returning to competition.160 however, the statute also re­ quires that the licensed health care provider be deemed .. appropriate," as determined by the state's board of education.161 this language provides flexibility in allowing the state board of education to determine the proper medical credentials necessary to perform concussion evaluation and man­ agement in youth athletics without providing an exhaustive listing of licens­ ing requirements within the statute itself. additionally, washington, 162 virginia, 163 and oklahoma, 164 all explic­ itly allow volunteers to be the licensed medical health care providers re­ sponsible for evaluating and authorizing the youth athlete to return to play. by allowing volunteers, these state statutes provide an element of flexibility for school districts to fully comply with return-to-play legislation in a more cost-effective manner. in addition to regulating the requirements of health care providers per­ forming return-to-play protocol, some state statutes impose a mandatory waiting period before allowing a youth athlete to return to sporting competi­ tion. specifically, oregon requires a youth athlete to sit out at least one day after the injury before returning to athletic competition.165 even more pre­ cautionary, new mexico does not allow a youth athlete to return to compe­ tition for at least one week after sustaining a brain injury.166 connecticut's statute is unique in incorporating a two-tiered approach in its return-to-play protocol. initially, a youth athlete may be granted writ­ ten medical clearance from a licensed health care professional to engage in supervised physical exertion.167 following initial clearance from the li­ censed health care professional to engage in restricted and supervised phys­ ical exertion, a youth athlete must receive a second written clearance from that licensed health care professional in order to·fully participate in athletic competition without any limitations on contact and physical exertion.168 accordingly, connecticut requires that coaches gradually introduce the 159. conn. gen. stat. ann.§ 10..149c(c) (west 2011). 160. va. code ann.§ 22.1-271.5(8)(2) (west 2011). 161. id. 162. wash. rev. code ann.§ 28a.600.190(4) (west 2011). 163. va. code ann.§ 22.1-271.5(b)(2) (west2011). 164. okla. stat. ann. tit. 70, § 24-155(c)(west2011). 165. or. rev. stat. ann.§§ 336.485(3)(a)-(b) (west 2011). 166. n.m. stat. ann.§ 22-13-3l(b) (west2011). 167. conn. gen. stat. ann.§ 10..149c(a)(~) (west 2011). 168. conn. gen. stat. ann.§ 10..149c(a)(3) (west 2011). 2012] "return-to-play" legislation 233 youth athlete back into athletic activity by mandating an initial limitation on physical exertion and continually monitoring the athlete's increased expo­ sure to physical contact and exertion over time. 6. neuropsychological testing rhode island's statute also encourages, but does not mandate, that schools perform baseline neuropsychological testing .· on student athletes to aide in concussion management.169 no other state's return-to-play protocol explicitly mandates or encourages any specific form of brain testing to be conducted in the evaluation and management of concussions in youth ath­ letes. n. current return-to-play guidelines in indiana return-to-play legislation was introduced in the indiana senate on january 5, 2011, and was passed by both houses in april2011.170 the gov­ ernor signed the bill on may 10, 2011, and it became effective .july 1, 2011.171 the indiana high school athletic association ("ihsaa") is the primary authority foneturn-to-play issues within indiana's youth· interscho­ lastic athletics until mandatory compliance of this law becomes effective during the 2012-2013 high school athletic season, at which time, regulating return-to-play will be the state's responsibility. the ihsaa requires member institutions to follow the concussion guidelines promulgated by the national federation of state high school associations (''nfhs").172 the current ihsaa protocol requires all mem­ ber school districts to immediately remove a player from a contest who ex­ hibits signs, symptoms, or behaviors consistent with a . concussion, including loss of consciousness, headache, dizziness, confusion, or balance problems.173 under the new indiana law, the statutory language is more specific than the ihsaa protocol. currently. the ihsaa protocol requires immediate removal only if the injury occurs during an athletic "contest."174 indiana's new law extends the requirement to include removal of a youth 169. rl. gen.lawsann. § 16-91-3(c)(west2011). 170. action list: senate bill 0093, indiana general assembly, http://www.in.gov/ apps/lsa/sessionlbillwatcblbillinfo?year=2011&request=getactions&doctype=sb&docno=o 093 (last visited july 11, 2011 ). 171. /d. 172. newell, supra note 1, at at. 173. quick resources: concussion protocol, ihsaa protocol for implementation of national federation of state high school associations (nfhs) sports playing rules for concussions, ihsaa.org, http://www.ihsaa.orgldnn!home/tabid/38/default.aspx (last visit­ ed mar. 10, 2011). 174. /d 234 indiana health law review [vol. 9:1 athlete from the playing field during a practice as well. 175 additionally, the current ihsaa protocol requires a youth athlete to be cleared by a "designated health care professional" before returning to competition.176 more specifically, the protocol requires game officials who observe a player suffering from an apparent concussion to inform coaches and to advise that the player be removed from competition to be evaluated by the school's designated health care professiona1.177 under the new indi­ ana law, the responsibility of removing the youth athlete from competition for medical evaluation is not specifically designated to game officials and, therefore, this responsibility would be more evenly spread among both coaches and game officials alike. 178 the ihsaa protocol clearly defines a "designated health care provid­ er" who may perform the initial screening of a youth athlete removed from competition as any of the following licensed professionals: medical doctor ("md") or doctor of osteopathic medicine ("do") who holds an unlimited license to practice medicine in the state of indiana; or a certified athletic trainer ("atc/l") licensed in the state oflndiana.179 by contrast, the new indiana law provides less restrictive language by allowing the initial medi­ cal evaluation to be performed "by a licensed health care provider trained in the evaluation and management of concussions and head injuries"180 with­ out listing any specific licensing or certification requirements. indiana's new law provides additional flexibility by allowing the licensed health care provider to be a volunteer health care provider. 181 according to current ihsaa protocol, if the designated health care provider determines that the youth athlete did not sustain a concussion and clears the athlete for play, then the head coach may advise game officials of the athlete's medical clearance from the md, do, or atc/l.182 the offi­ cial may then immediately allow the athlete to return to competition. 183 in contrast, the new indiana law does not include any explicit reference as to whether a youth athlete may immediately return to play following removal 175. ind. code§ 20-34-7-4 (2011). 176. quick resources: concussion protocol, ihsaa protocol for implementation of national federation of state high school associations (nfhs) sports playing rules for concussions, ihsaa.org, supra note 173. 177. id. 178. see ind. code§ 20-34-7-4 (2011). 179. quick resources: concussion protocol, ihsaa protocol for implementation of national federation of state high school associations (nfhs) sports playing rules for concussions, ihsaa.org, supra note 173. 180. ind. code§ 20-34-7-s(a)(l) (2011). 181. ind. code§ 20-34-7-s(b) (2011). 182. quick resources: concussion protocol, ihsaa protocol for implementation of national federation of state high school associations (nfhs) sports playing rules for concussions, ihsaa.org, supra note 173. 183. id. 2012] "return-to-play., legislation 235 and a subsequent negative initial diagnosis for concussion or head injury. 184 if the designated health care provider does not authorize the youth ath­ lete to return to competition, then the lllsaa protocol mandates the follow­ ing requirements be satisfied before the youth athlete may return to play: (1) only a md or do may clear the individual to return to competition; (2) the medical clearance must be in writing; and (3) the medical clearance may not be on the same date on which the athlete was removed from play.185 there­ fore, if the youth athlete is initially diagnosed as exhibiting signs of a con­ cussion or brain injury, an atc/l cannot authorize the subsequent medical clearance for the youth athlete to return to play.186 on the other hand, the new indiana law provides a less strict protocol. in the event a youth athlete is diagnosed with an apparent concussion or brain injury, the licensed health care provider must still provide written clearance for the youth athlete to return-to-play;187 however, there is no ex­ plicit requirement for a mandatory sit-out period. under the current lllsaa protocol, the official who decided to re­ move the youth athlete from competition must file a report of the incident with the local school district's athletic director.188 the official must file this report regardless of whether the athlete is allowed to return-to-play follow­ ing removal.189 furthermore, the school's athletic director is then required to file the report and make it available to the lllsaa website. 190 the new indiana law requires no formal documentation of the incident to be prepared or retained on file. 191 v. analysis of indiana's current "return-to-play" law a. indiana's new law on january 5, 2011, return-to-play legislation was first introduced on the floor of the indiana senate by senator travis holdman.192 the senator consulted with the lllsaa, nfl, american college of sports medicine, usa football, and a neurodevelopmental pediatrician at riley hospital for 184. see ind. code§ 20-34-7-5 (2011). 185. quick resources: concussion protocol. ihsaa protocol for implementation of national federation of state high school associations (nfhs) sports playing rules for concussions, ihsaa.org, supra note 173. 186. id. 187. ind. code§ 20-34-7-5 (2011). 188. quick resources: concussion protocol, ihsaa protocol for implementation of national federation of state high school associations (nfhs) sports playing rules for concussions, ihsaa.org, supra note 173. 189. id. 190. id. 191. see ind. code§ 20-34-7-5 (2011). 192. action list: senate bill 0093, inoiana general assembly, supra note 170. 236 indiana health law review [vol. 9:1 children in indianapolis, indiana prior to introducing the legislation.193 the new return-to-play statute is based on requirements already in place under ihsaa rules. the new return-to-play statute will require the following: (1) devel­ opment and communication of uniform concussion and head injury guide­ lines; (2) submission and retrieval of signed head injury information sheets; (3) immediate removal of a youth athlete from athletic competition after sustaining an apparent concussion or head injury; and (4) satisfaction of specific return-to-play protocol before allowing a youth athlete to partici­ pate again in athletic competition. each requirement is discussed in detail below. 1. uniform concussion and head injury guidelines first, the new indiana law requires the indiana department of educa­ tion to consult with the state's interscholastic athletic association to develop guidelines, information sheets, and forms on the nature and risk of concus­ sions and head injuries.194 next, the department of education must dissem­ inate the information to the schools for distribution to coaches, student athletes, and parents of student athletes. 195 2. signed information sheet and form the new law further requires that prior to beginning practice for each interscholastic or intramural sport, a concussion and head injury infor­ mation sheet and form must be given to the student athlete and the athlete's parent.196 the information sheet and formis to be developed by the de­ partment of education.197 in order to acknowledge and document receipt of the educational material, both the student athlete and the athlete's parent must sign and return the form to the student athlete's coach.198 the coach must then maintain the signed forms on file at the school. 199 3. immediate removal from play the new indiana law also requires that any student athlete suspected of sustaining a concussion or head injury must be immediately removed 193. nat newell, concussion bill would follow ihsaa 's lead, indy.com (jan. 5, 2011 ), http://www .indy.com/posts/concussion-bill-would-follow-ihsaa-s-lead. 194. ind. code§ 20-34-7-2(a)(20ll). 195. !d. 196. ind. code§ 20-34-7-3(1)(2011). 197. id. 198. ind. code§ 20-34-7-3(2)(2011). 199. ind. code§ 20-34-7-3 (2011). 2012] "return~ to~pla y" legislation 237 from the practice or game at the time of the injury.200 furthermore, the youth athlete is not allowed to return to athletic competition until the speci~ fied return~to~play protocol is satisfied.201 4. return-to-play protocol: written clearance from a licensed health care provider if a student athlete is removed from practice or competition, the new law then requires the youth athlete to be evaluated by a licensed health care provider trained in the evaluation of concussions and head injuries.2°2 the student athlete will not be allowed to return to athletic competition until receiving written medical clearance from the same licensed health care pro~ vider who evaluated the student athlete immediately following the injury.203 finally, the new law allows a licensed health care provider to volunteer his or her services for both the initial evaluation of the youth athlete and the subsequent medical clearance of the youth athlete prior to returning to com­ petition.204 b. critique of indiana's proposed legislation although the proposed return-to-play legislation in indiana covers the basic concussion and head injury issues for youth athletes enacted in other states, it misses the mark in terms of necessary safety precautions. the leg­ islation is almost directly modeled after the original washington statute,205 but suffers from the same ailments as its washington forebear. namely, critics argue the washington legislation is too weak, stating that "[t]he lystedt law, and other state legislation like it, still allows for mismanage­ ment of injuries. ,,z06 therefore, the following recommendations would suc­ ceed in bolstering the indiana return-to-play legislation, in both providing the necessary protection for youth athletes and establishing indiana at the forefront of increased safety standards regarding concussion and head inju­ ry management in youth athletics. 200. ind. code§ 20-34-7-4(1)(2011). 201. ind. code§ 20-34-7-4(2)(2011). 202. ind. code§ 20-34-7-5(a)(l) (2011). 203. ind. code§ 20-34-7-5(a)(2) (2011). 204. ind. code§ 20-34-7 -5(b )(20 11 ). 205. compare wash. rev. code ann.§§ 28a.600.190(2)(4) (west 2011), with ind. cone§§ 20-34-7-1-20-34-7-5 (showing similarity in the statutory language employed with only minor differences noted in terms of organization of the statutory requirements). 206. alan schwarz, despite law, town finds concussion dangers lurk, n.y. times, sept. 23,2010, at b15. 238 indiana health law revmw [vol. 9:1 1. uniform concussion and brain injury guidelines the new indiana law requires the department of education to develop and disseminate the concussion and head injury guidelines with only the assistance of the llisaa and merely suggests consultation with outside medical professionals.207 the new indiana law should further address in­ volvement in the development process of uniform guidelines. specifically, the law should mandate that representatives from local school districts work in concert with both indiana's department of education and the llisaa to develop standard guidelines. additionally, the law should require that input and research be obtained from other sources with specialized knowledge of concussion and head injury treatment and management including local med­ ical professionals. the key to the uniform guidelines' success will lie in adopting rules that adequately protect youth athletes but also allow school districts with limited financial resources the ability to comply. by requiring indiana's department of education, the llisaa, local school districts, and state medical professionals to collaborate, all voices will be heard and the appropriate provisions can be determined with all parties representing their unique positions. a second recommendation is to mandate rather than suggest that the guidelines be readily accessible from the llisaa's website, similar to the idaho statutory mandate that requires information be posted on the state board of education website.208 additionally, legislation should require an annual review of the uniform concussion and head injury guidelines by the llisaa and department of education, similar to new jersey's statutory requirement. 209 furthermore, any intermittent updates to the uniform guide­ lines that occur during the year should be communicated from the llisaa directly to local school districts when appropriate to provide the most up­ dated safety information. 2. mandatory concussion and head injury training indiana's new return-to-play law does not currently mandate any for­ mal educational training on concussion and head injury evaluation and management. the language in the. new law only requires information on the nature and risk of concussion be "disseminated" by indiana's depart­ ment ofeducation.210 this language is simply not strong enough to effect a proper mandate of concussion and head injury education to youth athletes and coaches. 207. ind. code§§ 20-34-7-2(a)(b) (2011). 208. compare ind. code§ 20-34-7-2(c) {2011) with idaho code ann. § 33-1625(2) (west20ll). · 209. n.j. stat. ann.§ 18a:40-41.3(a) (west20ll). 210. ind. code§§ 20-34-7-2(a) (20ll). 2012] "return-to-play" legislation 239 prior to the beginning of each athletic season, indiana's law should in­ clude mandatory training for all coaches and youth athletes subject to indi­ ana's interscholastic athletic association. the american academy of pediatrics' council on sports medicine and fitness purports that "[ r ]ecognition and education are paramount, because although proper equipment, sport technique and adherence to rules . . . may decrease the incidence or severity of concussions, nothing has been shown to prevent them."211 awareness of the signs and symptoms of concussions is critical to proper head injury evaluation and management. without proper education, youth athletes are not in the best position to recognize symptoms of concus­ sions and head injuries and to adequately protect themselves from potential long-term negative health effects. anonymous questionnaires released to high school football players after the season ended yielded information that 15% of athletes admitted to sustaining a concussion.212 through the same study, the number increased to about 50% when the word concussion was omitted and only concussion symptoms were listed.213 furthermore, 35% of the players reported suffering from two or more incidents of head trau­ ma.2i4 even more troubling is that youth athletes tend to shy away from self­ reporting injuries for fear of being perceived as weak by coaches and fellow teammates.215 furthermore, "[m]any athletes fear they will be stigmatized or demoted if they admit to being hurt, so they lie about their condition!'216 therefore, "it is important not only to inform athletes, coaches and parents of the risks of concussion but also to impress upon them the benefits of re­ porting and recovering from a concussion early on."217 a statute mandating annual concussion training would accomplish the necessary goal of educating coaches and youth athletes about the symptoms and dangers of not properly managing a head injury. the state mandate should provide school districts with a number of ways to train athletes on concussion and head injury awareness in a number of ways in order to bet­ ter accommodate various school budget constraints. for example, the train­ ing could be offered free online via the ihsaa website. the statutory language should not place a heavy administrative burden on individual 211. editorial, adults must use their heads in handling young athletes ' concussions, supra note 28. 212. alan schwarz. silence on concussions raises risks of injury, n.y. times, sept. 15, 2007, at al, available at http://www.nytimes.com/2007/09/15/sports/footballl 15concussions.html? r= 1. 213. id. 214. id. 215. see id. 216. rachel blount, mayo clinic out to check sports concussions, star tribune (minneapolis, minn.), oct. 21,2010, at 01a. 217. mccluskey, supra note 57. 240 indiana health law review [vol. 9:1 school districts to develop any sophisticated training, as it is unlikely that school districts of limited financial means would be able to comply. in short, the goal should be to equip coaches and youth athletes with general awareness of concussion symptoms and to stress the importance of seeking proper medical management if head injury symptoms present themselves during athletic competition. 3. personal brain injury information sheet and form the new indiana law only requires that the youth athlete and a parent of the youth athlete sign and return an information sheet and form providing general education on concussions and head injuries.218 this check-the-box type of requirement does not go far enough in providing proper concussion and head injury care. the statute should require every youth athlete to submit to the school district's athletic department a personal brain injury information form identifying any past history of concussion or other head injuries suffered by the youth athlete. also, the youth athlete's personal brain injury information form should be signed by both the youth athlete and his or her respective parent or guardian prior to participation in each athletic season. in order to relieve any additional administrative burden, the personal brain injury information could be reported as a section of the in­ formational sheet and form already required under the new law. the personal brain injury information form should be developed joint­ ly by the llisaa, indiana's department of health, and indiana's depart­ ment of education. the form should be reviewed annually along with the uniform concussion guidelines and updated as necessary to provide for the utmost safety of youth athletes. furthermore, for ease of access and to as­ sist with compliance, the llisaa should make the personal brain injury in­ formation form readily available on its website. overallt the cost of filling out the personal brain injury form would be marginal moreover, this provision would allow for local school athletic departments, coaches, and designated medical professionals to be aware of critical head injury history. in turn, this knowledge of a youth athlete's per­ sonal medical history will provide for better evaluation and management of the athlete in the event of a subsequent head injury. 4. impacttesting presently, the indiana law does not require any form of testing to as­ sist in concussion and head injury management. to further enhance proper medical decision-making, the indiana statute should require athletes from all ihsaa member schools to undergo baseline imp act testing by a li218. ind. code§ 20-34-7-3 (2011). 2012] "return-to-play" legislation 241 censed medical professional trained in concussion management before the start of every athletic season. this regulation would -allow all youth athletes to have a uniform testable basis from which a licensed health care provider. responsible for concussion evaluation and management could accurately' determine the proper course of action if an injury were to occur during the athletic season. if an injury occurs during a game or practice, indiana law should re­ quire a post-injury impact test to be conducted,. and those results should be measured against the youth athlete's baseline score. impact reduces the speculation in determining when a youth athlete is no longer suffering the effects of a brain injury and can return to the field. 219 "in fact, neu­ rocognitive testing has recently been called the 'cornerstone' of proper con­ cussion management by an international panel of sports medicine experts.'.no return-to-play legislation is not intended to add an expense to families of youth athletes or local school districts by requiring a potentially costly medical evaluation. the imp act test is an inexpensive twenty-minute test that can be conducted by "anyone trained to administer the baseline test­ ing.''221 local school districts may purchase the imp act tool on a yearly subscription for $500 to $1,000 depending on the anticipated number :of baseline tests and post-injury tests required 222 furthermore, additional baseline or post-injury imp act tests in excess of the purchased package can be bought as needed in incremental costs of two dollars for each base­ line test and ten dollars for each post-injury test.223 already, "[a]pproximately two-thirds of ·the schools in indiana use impact" according to dr. dan kraft, co-director of the irrdiana sports concussion network.224 this statistic suggests that only a minority of ihsaa member schools would need to implement baseline and post-injury imp act testing to achieve participation by all member schools. thus, a statutory mandate would be a useful mechanism of ensuring statewide im­ plementation of imp act. 5. return-to-play protocol: requirements of the licensed health care provider, gradual return-to-play, and a mandatory waiting period a key point of contention in the passage of return-to-play legislation 219. newell,supranote l,atal. 220. about impact: overview and features of the impact test, impactfest.com, supra note 63. · · 221. /d. 222. purchase: order formsfor academic institutio71s, high schools, colleges, and universities, impactfest.com, http://impacttest.com/purchase (last visited aug. 16, 2011). 223. /d. 224. newell, supra note 1, at ai. 242 indiana health law review [vol. 9:1 in other states has been defining the individuals qualified to evaluate and authorize a youth athlete's return to competition. in pennsylvania, pending legislation requires that return-to-play protocol be conducted "by a licensed or certified health care practitioner whose scope of practice includes the management and evaluation of concussions.'.ns dr. mike cordas, former football team physician at penn state, believes the terminology is danger­ ously unrestrictive, and he advises that "[y]ou have to have more than a sur­ face knowledge of concussions ... otherwise you're going to hurt somebody."226 as a result of this criticism, indiana should clearly defme and limit the class of individuals who can perform the initial evaluation and subsequent authorization to return-to-play to only those who specialize in brain injury evaluation and management. the new indiana law requiring evaluation and clearance by a "licensed health care provider trained in the evaluation and management of concussions and head injuries'.n7 teeters on the brink of those dangers noted by dr. cordas relative to the proposed pennsylvania statute. the qualifying word "trained" in indiana's new law provides too loose of a standard to ensure proper brain injury evaluation and injury man­ agement. it is imperative to include explicit language in the indiana statute that clearly identifies the specific medical professionals allowed to perform return-to-play procedures, including a non-exhaustive list of the types of appropriate state-licensed or state-certified medical personnel. amending the law to include a non-exhaustive list of qualified medical personnel would put the indiana statute on par with statutes in connecticuf'z8 and new mexico.229 a second recommendation concerning indiana's proposed return-to­ play protocol involves instituting a two-tiered approach to a youth athlete's return to competition similar to the connecticut statute. 230 the connecticut statute focuses on a supervised, gradual introduction to physical exertion. after sustaining a concussion, athletes should not return to play until symp­ toms have fully subsided, both before and after gradually increasing physi­ cal activity.231 more specifically, concussion experts advise that athletes "should follow a guided exercise progression for seven days after becoming symptom-free before returning to full participation.'.232 225. chuck finder, pa. house concussion bill draws a mrxed reaction congress also wrestling with issue of brain injuries, piti'sburghpost-gazetie, sept 30,2010, at bl. 226. /d. 227. ind. code§ 20-34-7-5(a)(2011). 228. conn. gen. stat. ann.§ l0-149c(c) (west 2011). 229. n.m. stat. ann.§ 22-13-31(f)(5) (west 2011). 230. conn. gen. stat. ann.§§ l0-149c(ax2)-(3) (west20ll). 231. schwarz, supra note 206, at b 15. 232. louise continelli, sharing insight on sports-related concussions, buffalo news (n.y.), feb. 6, 2011, § niagara week, at 1 {quoting dr. anthony surace, director of sports medicine at the university sports medicine ofniagara concussion clinic). 2012] "return-to-play'' legislation 243 the sponsor of indiana's new law, senator travis holdman, stated that "doctors around the state are still seeing kids go back to sports too ear­ ly."233 accordingly, the law in indiana should mandate a youth athlete be first granted an initial written medical clearance from an appropriate li­ censed health care professional allowing engagement in limited, supervised physical exertion. following this initial clearance from the appropriate li­ censed medical professional to re-engage in limited physical activity, a youth athlete should then be required to receive a second written clearance from the same licensed medical professional authorizing full participation in athletic competition. the ability to monitor a youth athlete's recovery through gradual increases in physical exertion will better safeguard the ath­ lete from returning too quickly and decrease the likelihood of sustaining a subsequent and potentially more dangerous medical injury. finally, with the difficulty in gauging concussion symptoms and the medical uncertainty regarding concussions and head injuries, it seems the most risk-averse approach would be for the proposed indiana legislation to be amended to institute a mandatory waiting period even after concussion and head symptoms subside. as dr. joseph o'neil of riley hospital in indianapolis advocates: the more we have learned about the effects of a con­ cussion on a young brain, the more we are concerned that the brain needs time to rest and heal. ... if we al­ low the student-athlete to get back into competition or practice too soon it slows down the healing process and also puts the young person at risk for greater inju­ ry.234 concussion specialists have recently emphasized the critical need for a rest period even after an athlete is asymptomatic.235 specifically, one con­ cussion expert advised that patients should wait seven to ten days after they become symptom-free before returning to full athletic competition, stating that "[t]here are biochemical changes occurring in the brain that must return to baseline before returning to full participation.'.236 therefore, indiana's new law should be amended to include amanda­ tory waiting period. the waiting period should be imposed immediately after a youth athlete is removed from competition and is initially deemed to have suffered a concussion or head injury. while oregon's statute requires 233. niki kelly, state law on concussions proposed: bill tightens rules for studentathletes who get hurt, journalgazetie(ft. wayne, ind.), dec. 30,2010, at lc. 234. !d. 235. continelli, supra note 232, at 1. 236. !d. {quoting dr. anthony surace, director of sports medicine at the university sports medicine ofniagara concussion clinic). 244 indiana health law review [vol. 9:1 a youth athlete to sit out at least qne day following injury,237 new mexico's more expansive one-week standard238 would provide an even greater oppor­ tunity to, properly evaluate a youth athlete's progression through recovery. furthermore, a mandatory one-week waiting period would aid in allowing the youth athlete ample time to be monitored and evaluated through the suggested two-tiered gradual return-to-play protocol described above. vi. conclusion it is without question that the issue of concussions and other head in­ juries in youth athletes is a major issue nationwide. the u.s. congress tried to enact federal legislation last year, but failed to do so, citing a lack of time to give the bill full consideration.239 in the absence of a federal man­ date, a handful of states have either specific return-to-play legislation or general concussion management statutes currently in force. numerous oth­ er states have proposed similar legislation. although indiana youth athletic programs tied to the ihsaa already have a protocol in place based on guidelines promulgated by the nfhs, the current measures do not go far enough and would not carry the weight and breadth of protection that a statutory mandate can provide. currently, the new indiana law provides only basic precautions that must be strengthened to eliminate potential inefficiencies and loopholes. a wider circle of minds should be involved in the development of statewide uniform concussion and head injury guidelines. specifically, representa­ tives from local school districts should be consulted along with other organ­ izations possessing specialized knowledge in the treatment and management of concussion and other head injuries. additionally, amending the legislation to include a mandate for a con­ cussion and head injury safety-training program would put coaches, youth athletes, and parents or guardians on notice of the dangers of playing sports with regard to traumatic brain injuries. the recommended improvements to indiana's current return-to-play legislation described in this note would also mandate baseline and post-injury imp act testing for all school athlet­ ic programs, which will provide a uniform and more accurate way to evalu­ ate and manage all youth athletes suffering from potentially dangerous head and brain injuries. furthermore, the suggested enhancements to indiana's new law out­ lined in this note would streamline the return-to-play process by clearly defining the specific medical professionals qualified to conduct the youth athlete's initial evaluation and subsequent written authorization to return-to237. or. rev. stat. ann.§ 336.485(3)(b) (west 2011). 238. n.m. stat. ann.§ 22-l3-3l(b) (west 2011). 239. friedman, supra note 25, at 26. 2012) "return-to-play" legislation 245 play, establishing a two-tiered return-to-play protocol focusing on a super­ vised, gradual return to athletic competition and establishing a uniform mandatory waiting period within which. to appropriately evaluate a youth athlete's recovery from a concussion or suspected brain injury. although a youth athlete may resist being removed from athletic com­ petition due to a suspected concussion or head injury, the state must consid­ er whether the reward of winning a game is really worth the potential long­ term health risks of not removing that athlete from play. zackery lystedt's family valiantly fought for passage of the first state statutory mandate for concussion and head injury protection and they "know only too well the ramifications of hoping for the best when, in fact, the worst may be just the next hit away."240 it is imperative for indiana to amend its current return­ to-play law to provide effective yet fiscally manageable requirements in the name of protecting youth athletes from serious harm. as kathy malone sparks, sports medicine services coordinator for indianapolis public schools puts it, "[y]ou only have one brain, and you'll need it later in life."24i 240. sandsberry, supra note 11. 241. newell, supra note 1, at al. indiana’s punitive responses to prenatal marijuana use: a recommendation for the indiana legislature indiana health law review volume xxii 2025 number 1 notes indiana’s punitive responses to prenatal marijuana use: a recommendation for the indiana legislature sarah brown * i. introduction forty-three years ago, president ronald reagan stated marijuana was “probably the most dangerous drug in the united states.” 1 reagan’s presidency was, in part, defined by his expansion of president richard nixon’s proclaimed “war on drugs,” an era of united states’ law and policy which increased punishment for use and possession of many illegal drugs, including marijuana. 2 although the “war on drugs” has gradually relaxed and led to the full or partial legalization of marijuana in thirty-eight states, 3 the effects of the “war” are still felt throughout the country. specifically, indiana retains “war on drugs” era policies through its child abuse statutes which penalizes maternal marijuana use. indiana child abuse statutes govern the treatment of children born marijuana positive. under indiana law, a child is considered a “child in need of services” (chins)4 if any amount, including a trace amount, of marijuana is found in their system and the child needs care, treatment, or rehabilitation that is unlikely without court intervention. 5 furthermore, hospital drug testing policies and the indiana department of child services (dcs) supports indiana’s legal framework by discovering, investigating, and civilly pursuing cases of ————————————————————————————— * jd candidate 2025, indiana university robert h. mckinney school of law. the author thanks professor frank sullivan jr., katie kelsey, and professor michael pitts for their support of this note. the author also thanks the editors of the indiana health law review for their support in preparing this note for publication. 1. kyle jaeger, how marijuana ruined ronald reagan’s valentine’s day, marijuana moment (feb. 14, 2019), https://www.marijuanamoment.net/how-marijuana-ruined-ronaldreagans-valentines-day/ [https://perma.cc/6wq8-sczn]. 2. war on drugs, history.com (may 31, 2017), https://www.history.com/topics/crime/thewar-on-drugs [https://perma.cc/98gm-w29y]. 3. state medical cannabis laws, nat’l conf. of state legislatures (june 22, 2023), https://www.ncsl.org/health/state-medical-cannabis-laws [https://perma.cc/tgk6-mj7d]. 4. chins is a term which includes a wide array of circumstances of child abuse and neglect. see ind. code § 31-34-1-1 (2024) (circumstances under which a child is a child in need of services). 5. ind. code § 31-34-1-10 (2024). https://www.marijuanamoment.net/how-marijuana-ruined-ronald-reagans-valentines-day/ https://www.marijuanamoment.net/how-marijuana-ruined-ronald-reagans-valentines-day/ https://www.history.com/topics/crime/the-war-on-drugs https://www.history.com/topics/crime/the-war-on-drugs https://www.ncsl.org/health/state-medical-cannabis-laws https://perma.cc/tgk6-mj7d https://perma.cc/98gm-w29y https://history.com https://perma.cc/6wq8-sczn indiana health law review [vol. 22:125 126 marijuana-positive infants.6 although the indiana court of appeals held in 2015 that in-utero marijuana exposure standing alone is not a sufficient basis to support a child abuse or neglect petition, 7 dcs continues involvement in such families. 8 while these laws and policies are meant to protect infants from abuse through the agency’s involvement, medical racism and a lack of trust between a health care provider and patients causes numerous harms to families. prenatal marijuana use is a common occurrence in the united states. between 2016-2017, 7% of pregnant individuals self-reported marijuana use during pregnancy. 9 however, self-reported data can be inaccurate 10 and use among certain populations are estimated to be higher. for example, 14–28% of low-income, urban women are estimated to use marijuana during pregnancy. 11 research has not conclusively connected in-utero marijuana exposure to any adverse infant health outcomes. 12 although some research has suggested a connection with low birth weight, these connections have not been definitively proven. 13 the harm to families created by indiana’s response to prenatal marijuana use outweighs the potential harms to the infant exposed. this note will discuss the effects of prenatal marijuana use on mother and infant and the relevant policies and laws which currently govern the indiana’s response to marijuana-exposed infants. additionally, this note will address the harms resulting from these policies and laws, potentials for reform within indiana hospitals and dcs, and end with a recommendation that indiana legislature exclude marijuana from the state’s definition of child abuse. ————————————————————————————— 6. most states do not have criminal penalties for maternal drug use. in states with criminal statutes, the focus is on opioid use. see emma coleman, many states prosecute pregnant women for drug use. new research says that’s a bad idea, vand. univ. ctr. for child health pol’y (dec. 5, 2019), https://www.vumc.org/childhealthpolicy/news-events/many-states-prosecutepregnant-women-drug-use-new-research-says-thats-bad-idea [https://perma.cc/9g79-rmgx]. 7. a.m. v. ind. dep’t of child servs. (in re s.m.), 45 n.e.3d 1252, 1256 (ind. ct. app. 2015). 8. see generally a.m. v. ind. dep’t of child servs. (in re ad.m.), 103 n.e.3d 709, 711-712 (ind. ct. app. 2018). 9. nora d. volkow et al., self-reported medical and nonmedical cannabis use among pregnant women in the united states, 322 jama 167, 168 (2019). 10. nat’l acads. scis., eng’g, and med., the health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research 245 (robert pool ed. 2017). 11. samarth shukla & harshit doshi, marijuana and maternal, perinatal, and neonatal outcomes, eur. pmc (2023), https://europepmc.org/article/nbk/nbk570616#__nbk570616_ dtls__ [https://perma.cc/8z3b-2v9d]. 12. comm. obstetric prac., committee opinion no. 722: marijuana use during pregnancy and lactation, 130 am. coll. obstetricians & gynecologists 205, 206 (2017). 13. hanan el marroun et al., intrauterine cannabis exposure affects fetal growth trajectories: the generation r study, 48 j. am. acad. child & adolescent psychiatry 1173, 1181 (2009). https://perma.cc/8z3b-2v9d https://europepmc.org/article/nbk/nbk570616#__nbk570616 https://perma.cc/9g79-rmgx https://www.vumc.org/childhealthpolicy/news-events/many-states-prosecute 2025] a recommendation for the indiana legislature 127 ii. background a. what is marijuana? marijuana is an alternative name for cannabis, a plant within the hemp family.14 marijuana is hemp that contains primarily two chemicals: delta-9tetrahydrocannibinol and cannabinol. 15 delta-9-tetrahydrocannibinol (thc) is a psychoactive chemical which causes the user to feel an euphoric high. 16 thc crosses the placenta and can reach high concentrations in infant’s systems due to repeated in-utero exposure. 17 thc-containing products can be smoked, ingested, vaporized, or topically applied depending on the type of product used,18 and the potency of thc substance differs depending on the type of product.19 conversely, cannabinol (cbd) does not deliver the same psychoactive effects as thc, therefore, users do not feel a “high” after consumption. 20 cbd produces the opposite effect of thc as it functions to decrease the psychological reactions of thc when consumed together. 21 isolated cbd has been shown to reduce anxiety, inflammation, and produce sedative-like effects. 22 there are three common types of thc-related products: marijuana, isolated cannabidiol (cbd), and delta-8 tetrahydrocannabinol (delta-8). marijuana is currently illegal in the state of indiana and it is classified as a schedule 1 narcotic. 23 to be classified as schedule 1, the indiana legislature must determine that the substance has a high potential for abuse, has no accepted medical use in treatment, and there is a lack of accepted safety for use under medical supervision. 24 marijuana was legal in the state until 1913 when its use was restricted and only allowed with a doctor’s prescription. 25 marijuana use for medical reasons became illegal after the passage of the controlled substances ————————————————————————————— 14. see leslie l. iversen, the science of marijuana 5 (1st ed. 2000). 15. zerrin atakan, cannabis, a complex plant: different compounds and different effects on individuals, 2 therapeutic advances psychopharmacology 241, 241 (2012). 16. shukla & doshi, supra note 11. 17. id. 18. center for disease control and prevention, what we know about marijuana, (sept. 9, 2021), https://www.cdc.gov/marijuana/what-we-know.html [https://perma.cc/3revx8wx]. 19. stacy steigerwald et al., the form and content of cannabis products in the united states, 33 j. gen. internal med. 1426, 1428 (2018). 20. cbd: what you need to know, centers for disease control and prevention (aug. 8, 2022), https://www.cdc.gov/marijuana/featured-topics/cbd.html#:~:text=cannabidiol%20 (cbd)%20is%20a%20compound,not%20cause%20a%20 [https://perma.cc/vdt4-tl2n]. 21. atakan, supra note 15, at 245. 22. id. 23. ind. code § 35-48-2-4(d)(22) (2024). 24. ind. code § 35-48-2-3 (1976). 25. indiana marijuana laws 2024, indiana cannabis information https://indiana cannabis.org/laws# [https://perma.cc/3jhu-48h4] (last visited jan. 31, 2024). https://perma.cc/3jhu-48h4 https://cannabis.org/laws https://indiana https://perma.cc/vdt4-tl2n https://www.cdc.gov/marijuana/featured-topics/cbd.html#:~:text=cannabidiol%20 https://perma.cc/3rev https://www.cdc.gov/marijuana/what-we-know.html indiana health law review [vol. 22:125 128 act of 1970 which federally classified marijuana as a schedule 1 narcotic. 26 in 2024, all bills in the indiana legislature regarding the full or partial legalization of marijuana have failed.27 the second product available in indiana is isolated cbd. although isolated cbd is not meant to contain noticeable levels of thc, cbd products are susceptible to manufacturing deficiencies and mislabeling, resulting in an estimated 21% of cbd products containing levels of thc which can appear on a drug test.28 in the indiana 2024 legislative session, bills aiming to create regulatory testing and packaging requirements for low thc hemp products are pending in the senate. 29 cbd products are widely available throughout indiana in a variety of products such as oils, edibles, and topical lotions. 30 furthermore, cbd became legal in indiana following the passage by congress of the 2018 farm bill. 31 the 2018 farm bill federally legalized products containing less than 0.3% of thc 32 and indiana adopted the federal law into the indiana code within a year. 33 lastly, delta-8 tetrahydrocannabinol (delta-8) is another product created from hemp. delta-8 is a psychoactive substance derived from the cannabis sativa plant, a type of marijuana, 34 which will result in a positive thc drug test if used. 35 delta-8 is commonly found in smokable oils and edibles which can be purchased at a variety of stores throughout indiana. similarly to cbd, delta-8 became legal in indiana after the passage of the 2018 farm bill. 36 however, the legality of delta-8 is currently being assessed. delta-8’s legal status in indiana ————————————————————————————— 26. 21 u.s.c. § 812 (1970). 27. s.b. 107, 123rd gen. assemb., second reg. sess. (ind. 2024) (establishing regulations for the production and sale of cannabis); h.b. 1146, 123rd gen. assemb., second reg. sess. (ind. 2024) (legalizing medical marijuana); h.b. 1282, 123rd gen. assemb., second reg. sess. (ind. 2024); h.b. 1350, 123rd gen. assemb., second reg. sess. (ind. 2024); h.b. 1410, 123rd gen. assemb., second reg. sess. (ind. 2024); h.b. 1349, 123rd gen. assemb., second reg. sess. (ind. 2024) (decriminalizing personal use marijuana possession). 28. staff sgt. tony harp, cbd can trigger positive drug test, joint base san antonio (jan. 16, 2020), https://www.jbsa.mil/news/news/article/2057582/cbd-can-trigger-positivedrug-test/#:~:text=the%20simple%20answer%3a%20no.,military%20drug%20demand%20 reduction%20program [https://perma.cc/jnp9-hm26]. 29. s.b. 59, 123rd gen. assemb., second reg. sess. (ind. 2024) (creating requirements for testing and packaging of hemp products); s.b. 175, 123rd gen. assemb., second reg. sess. (ind. 2024) (creating packing regulations for low thc hemp products). 30. cbd: what you need to know, supra note 20. 31. agricultural improvement act of 2018, pub. l. no. 115-334 §10113, 132 stat. 4490, 4908 (2018). 32. id. 33. ind. code § 15-15-13-7 (2019). 34. 5 things to know about delta-8 tetrahydrocannabinol – delta-8 thc, fda (may 4, 2022), https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8tetrahydrocannabinol-delta-8-thc [https://perma.cc/9zqd-9ecq ]. 35. sian ferguson, does delta-8 show up on a drug test?, healthline (mar. 15, 2023) https://www.healthline.com/health/does-delta-8-show-up-on-a-drug-test [https://perma.cc/43tzzt7w]. 36. ind. code § 15-15-13-7 (2019). https://perma.cc/43tz https://www.healthline.com/health/does-delta-8-show-up-on-a-drug-test https://perma.cc/9zqd-9ecq https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8 https://perma.cc/jnp9-hm26 https://www.jbsa.mil/news/news/article/2057582/cbd-can-trigger-positive 2025] a recommendation for the indiana legislature 129 may change due to indiana attorney general todd rokita’s advisory opinion stating that the substance is illegal in the state due to the prohibition on marijuana. 37 b. pregnancy and thc use 1. why do women use marijuana during pregnancy? skeptics of marijuana question why a women would use the substance while pregnant. in fact, stigma and guilt caused by marijuana use is a major reason many women choose to stop use during pregnancy. 38 nevertheless, many choose to continue to use it for a variety of motivations. a 2021 study found three main reasons mothers use marijuana during pregnancy: recreational enjoyment, symptom and pain management, or emotional coping. 39 the majority of participants identified more than one category for their use. 40 however, the most common reason was for symptom and pain management during pregnancy. 41 many used marijuana outside of the advice of a medical professional and believed marijuana eased their nausea and vomiting more effectively than prescribed medications. 42 only one participant identified their sole reason for use as recreational enjoyment. 43 the stigma surrounding prenatal marijuana use also affects the mother’s consumption. although the exact risks of marijuana use are largely unknown to both medical providers and expecting mothers, a study found a universal agreement from all participants that there was a high risk of being reported to child protective services if the use was revealed to a healthcare provider. 44 furthermore, most women attempted to decrease their use or quit use altogether during the third trimester, 45 likely to avoid detection. cultural effects from legalized areas of the united states may also be influencing overall maternal marijuana use. a 2020 study found that women ————————————————————————————— 37. tetrahydrocannabinol variants and other designer cannabinoid products, ind. op. att’y gen. 2023-1, 1–2 (2023); see also 3c, llc v. rokita, no. 23-cv-01115-jrs-mkk, 2024 wl 1348221 (s.d. ind. mar. 29, 2024); marella porter, decisions on delta 8 ban in indiana expected following lawsuit, wkrc news (jan. 19, 2024) https://local12.com/news/local/ decisions-on-delta-8-ban-in-indiana-expected-any-day-following-lawsuit# [https://perma.cc/ 35gf-wuhy]. 38. meredith vanstone et al., reasons for cannabis use during pregnancy and lactation: a qualitative study, 193 can. med. ass’n j. 1906, 1910 (2021). 39. id. at 1906. 40. id. 41. id. at 1910. 42. id.; see also judy c. chang et al., beliefs and attitudes regarding prenatal marijuana use: perspectives of pregnant women who report use, 196 drug & alcohol dependence 14, 16 (2019). 43. vanstone et al., supra note 39, at 1906. 44. chang et al., supra note 43. 45. id. https://perma.cc https://local12.com/news/local indiana health law review [vol. 22:125 130 residing in legal recreational marijuana states were 2.21 times more likely to use marijuana during pregnancy compared to those in illegal states. 46 furthermore, a 2018 study found that 70% of colorado marijuana dispensaries recommended cannabis to pregnant women to treat nausea during the first trimester. 47 the uncertainty surrounding the effects of maternal marijuana use and the perceived benefits of use from cannabis industry actors has culminated in an online community of mothers that recommend use during pregnancy. due to the illegality of marijuana and the fear of child protective services involvement, many women turn to online chat rooms for information rather than seeking out the advice of healthcare professionals. 48 these online chat rooms focus more on personal testimonies and experiences and questions about hospital testing policies is the topic with the highest frequency of posts. 49 the most common post in these chat rooms are state-specific questions looking for information on how to avoid detection from child services in the mother’s home state. 50 the stigma of prenatal marijuana use and the culture of fear surrounding child services involvement encourages mothers who are using to seek out nonmedical advice online which could have detrimental effects on prenatal care. 51 2. marijuana’s effects on infants marijuana use among pregnant women is rising in the united states.52 healthcare providers are advised to never encourage the use of marijuana during pregnancy. 53 however, there is currently insufficient data to support any adverse effects of in-utero marijuana exposure in infants. 54 specifically, research has found no connection between maternal marijuana use and the adverse pregnancy outcomes of small for gestational age; spontaneous preterm birth; and pregnancy hypertensive disorders. 55 furthermore, neonatal intensive care unit admission rates are not statistically different between marijuana-positive infants and non-positive infants. 56 overall, current research does not connect maternal ————————————————————————————— 46. kara r. skelton et al., recreational cannabis legalization in the us and maternal use during the preconception, prenatal, and postpartum periods, 17 int’l j. env’t rsch. & pub. health 909, 912 (2020). 47. betsy dickson et al., recommendations from cannabis dispensaries about firsttrimester cannabis use, 131 obstetrics & gynecology 1031, 1032 (2018). 48. cynthia n lebron, et al., “ganja mamas”: online discussions about cannabis use in pregnancy, 241 drug & alcohol dependence 109689, 109691 (2022). 49. id. at 109697. 50. id. at 109692. 51. id. at 109697. 52. kelly c. young-wolff et al., rates of prenatal cannabis use among pregnant women before and during the covid-19 pandemic, 326 jama 1745, 1745 (2021). 53. comm. obstetric prac., supra note 12, at 205. 54. id. at 206. 55. torri metz et al., maternal marijuana use, adverse pregnancy outcomes, and neonatal morbidity, 217 am. j. obstetrics & gynecology 478, 484 (2017). 56. id. at 479. 2025] a recommendation for the indiana legislature 131 marijuana use to risks of physical harm or deformities in infants exposed inutero. 57 however, some studies suggest a risk of physical harm to infants’ post-birth from in-utero marijuana exposure, however, these findings are not certain. some studies have found a connection between maternal marijuana use and low birth weight, however, inconsistencies in the studies call their findings into question. 58 many of the studies rely on birth weight alone which is not reliable indicator for fetal growth, utilize small sample sizes, and do not account for the potency of the marijuana used by the pregnant person. 59 furthermore, it is difficult to discern the exact effects of marijuana on infants because marijuanapositive infants are at a higher risk of also being exposed to tobacco, alcohol, or other illicit drugs. 60 the college of obstetricians and gynecologists has recommended individuals discontinue marijuana use during pregnancy, however, their reaffirmed 2021 opinion states there is no current association between marijuana use and increased risk of stillbirth, low birth weight, and pre-term birth. 61 furthermore, the college of obstetricians and gynecologists stated that many studies on maternal marijuana use are limited by the use of animals in the research and the effect of tobacco use on the affected infants. 62 overall, the current research does not connect marijuana use alone to adverse infant health outcomes and the current opinion is that the risk of harm is minimal. 63 c. indiana law 1. indiana child welfare statute § 31-34-1-10 indiana child welfare statutes, referred to as child in need of services (chins) law, is the primary source of law that governs the penalties for marijuana-positive infants. indiana chins statutes require three conditions to support a child welfare petition: (1) the child is under eighteen years old; (2) the abuse or neglect meets one of the eleven statutory definitions of abuse or neglect; and (3) the child needs intervention from the court. 64 indiana dcs must prove the three conditions by a preponderance of the evidence to adjudicate the ————————————————————————————— 57. comm. obstetric prac., supra note 12, at 206. 58. marroun et al., supra note 13, at 1181. 59. id. 60. see comm. obstetric prac., supra note 12; sheryl a. ryan et al., marijuana use during pregnancy and breastfeeding: implications for neonatal and childhood outcomes, 142 am. acad. pediatrics 1889 (2018); see also shukla & doshi, supra note 11. 61. comm. obstetric prac., supra note 12, at 206. 62. id. at 207. 63. id. 64. m.y. v. state dep’t of child servs. (in re k.y.), 145 n.e.3d 854, 860 (ind. ct. app. 2020); see also a.r. v. ind. dep’t of child servs. (in re a.r.), 121 n.e.3d 598, 603 (ind. ct. app. 2019). indiana health law review [vol. 22:125 132 child a child in need of services. 65 among the statutory definitions of abuse or neglect is indiana law section 31-34-1-10, which states: (1) the child is born with: (a) fetal alcohol syndrome; (b) neonatal abstinence syndrome; or (c) any amount, including a trace amount of a controlled substance, a legend drug, or a metabolite of a controlled substance or legend drug in the child’s body, including the child’s blood, urine, umbilical cord tissue or meconium; and (2) the child needs care, treatment, or rehabilitation that: (a) the child is not receiving; or (b) is unlikely to be provided or accepted without the coercive intervention of the court.66 the statute specifically defines maternal controlled substance use during pregnancy as conduct that can cause a child to be deemed a victim of abuse or neglect. 67 marijuana is a schedule i narcotic in indiana. 68 therefore, any trace amount of thc detected in a newborn satisfies section 31-34-1-10. the judicial intervention condition of a child in need of services statute is the most difficult to prove in cases of marijuana-positive infants. there is little uniformity among indiana courts in whether prong three is met in cases in-utero marijuana exposure. 69 although sole marijuana use with no aggravating factors is unlikely to meet the threshold of prong three, judges have vast discretion in a chins determination. many times, the judge will adjudicate the child as a child in need of services if the parent is low income, has a prior criminal history, has a prior history of substance use, or has had any contact with dcs in the past. 70 ————————————————————————————— 65. ind. code § 31-34-12-3 (2024); see also a.c. v. ind. dep’t of child servs., 198 n.e.3d 1, 12 (ind. ct. app. 2022). 66. ind. code § 31-34-1-10 (2024). 67. id. 68. ind. code § 35-48-2-4(d)(22) (2024). 69. see j.j. v. ind. dep’t of child servs. (in re k.s.), 78 n.e.3d 740, 745 (ind. ct. app. 2017) (reversed lower court’s finding of chins); d.v. v. ind. dep’t of child servs. (in re b.v.), 110 n.e.3d 437, 441 (ind. ct. app. 2018) (reversed lower court’s finding of chins due to dcs support of the reversal). 70. see roark v. roark, 551 n.e.2d 865, 872 (ind. ct. app. 1990) (holding evidence of injury to other children not involved in the current case is admissible); see also in re j.l.v., jr., 667 n.e.2d 186, 190 (ind. ct. app. 1996) (finding that evidence of mother’s prior involvement with dcs was admissible for a case involving a latter born child); in re k.s., 78 n.e.3d at 743 (discussing mother’s housing status). 2025] a recommendation for the indiana legislature 133 2. legislative history of § 31-34-1-10 the current indiana code section 31-34-1-10 was adopted in 1997. 71 prior to 1997, indiana did not include any language classifying the mere presence of any amount of a controlled substance as evidence of a child being a child in need of services. 72 instead, the statute required that the child either be addicted to the controlled substance upon birth or born with injury or developmental issues caused or aggravated by the mother’s use of the controlled substance during pregnancy. 73 similarly to the current version of the statute, the pre-1997 code also required that the child need the coercive intervention of the court to justify involvement. 74 the current code section conflates any use of a controlled substance during pregnancy with abuse while the pre-1997 code focused more on the harms of use when determining abuse. 75 although the current code section requires dcs to show the need for the coercive intervention of the court to support a chins adjudication,76 this broad language allows for nonuniform application depending on the jurisdiction or judge hearing the case. however, the harmcentered language of the pre-1997 statute ensures that evidence of the infant’s injury or addiction to a controlled substance must be shown by dcs in chins cases. 77 indiana’s purpose when writing the 1997 family law code was to present the code “in a style that is clear, concise, and easy to interpret and apply.” 78 however, it is unclear why the indiana legislature chose to change the language of the statute in 1997. one possible explanation is that infant drug testing did not become common until the mid-1980s79 and the indiana legislature added the “trace amount” language to reflect the new capabilities of drug testing procedures. wide-spread infant drug testing was a direct response from the war on drugs and the panic caused by the “crack baby” epidemic of the 1980s.80 the “crack baby” epidemic was a period of united states history which promoted the idea that mothers, predominantly black mothers, who used crack cocaine were substantially harming their infants. 81 the “crack baby” panic not only led to mass infant drug testing procedures, but also resulted in many states passing ————————————————————————————— 71. ind. code § 31-34-1-10 (2024). 72. see ind. code § 31-6-4-3.1 (1996) (repealed). 73. id. 74. id. 75. ind. code § 31-34-1-10 (2024); cf. ind. code § 31-6-4-3.1(1996) (repealed). 76. ind. code § 31-34-1-10 (2024). 77. ind. code § 31-6-4-3.1 (1996) (repealed). 78. id. 79. theresa kurtz & marcela c. smid, challenges in perinatal drug testing, 140 j. obstetrics & gynecology 163, 163 (2022). 80. id. 81. katharine mccabe, criminalization of care: drug testing pregnant patients, 63 j. health & soc. behav. 162, 163 (2022). indiana health law review [vol. 22:125 134 laws to include prenatal substance use as a form of child abuse. 82 although it is unclear if the “crack baby” panic and subsequent availability of infant drug testing influenced the indiana legislature, the historical context reflects the government’s views and attitudes towards prenatal substance use in the 1990s. d. application of the law 1. hospital policies generally, there are three types of drug testing procedures for infants: meconium, umbilical cord, and urine testing. meconium is a substance passed by a newborn during his or her first bowel movement. 83 meconium testing is an extremely accurate method for drug testing 84 and the test can generally detect maternal marijuana use from twenty-four weeks gestation to birth. 85 umbilical cord testing is also extremely accurate for infant drug testing, however, it differs from meconium as it will not reveal positives for any drug given to the infant post-birth. 86 similarly to meconium, an umbilical cord test will reveal maternal marijuana use from twenty-four weeks gestation to birth.87 lastly, urine testing is more difficult to administer on newborn patients 88 and the method only shows maternal marijuana use from thirty-two weeks gestation to birth.89 therefore, it is recommended that hospital staff primarily utilize meconium or umbilical cord testing. 90 in indiana, hospitals have discretion to determine their own drug testing policies which leads to large discrepancies as to which individuals are tested, how they are tested, and when they are tested. in 2018, iu health assessed and evaluated all pregnant patients on an individual basis. 91 conversely, in 2018 at community health network, all pregnant individuals were drug tested upon being admitted for delivery and the infant was automatically drug tested with ————————————————————————————— 82. id. 83. edward c. maynard et al., meconium for drug testing, 145 am. j. diseases child. 650, 652 (1991). 84. id. 85. colo. dep’t. pub. health & env’t, marijuana pregnancy and breastfeeding guidance for colorado health care providers, (mar. 18, 2015). https://wicworks.fns.usda.gov/sites/ default/files/media/document/mjpregbreastfeedingguidelines.pdf [https://perma.cc/jvs6-z3 eg]. 86. kendra l. palmer et al., evaluating a switch from meconium to umbilical cord tissue for newborn drug testing: a retrospective study at an academic medical center, 50 j. clinical biochemistry 255, 256 (2017). 87. colo. dep’t. pub. health & env’t, supra note 82, at 1. 88. maynard et al., supra note 83, at 650. 89. colo. dep’t. pub. health & env’t, supra note 85, at 1. 90. maynard et al., supra note 83, at 651. 91. nina criscuolo, marijuana and mothers-to-be: potential impacts and how local hospitals are tracking drug use, wishtv (jan. 11, 2018, 8:03 am), https://www.wishtv.com/ news/marijuana-and-mothers-to-be-potential-impacts-and-how-local-hospitals-are-trackingdrug-use/ [https://perma.cc/g32x-e5sm]. https://perma.cc/g32x-e5sm https://www.wishtv.com https://perma.cc/jvs6-z3 https://wicworks.fns.usda.gov/sites 2025] a recommendation for the indiana legislature 135 either an umbilical cord or meconium screen upon a positive maternal test. 92 st. vincent also universally screened all pregnant individuals upon admittance in 2018, however, if a pregnant woman did not consent to testing, the infant’s umbilical cord was automatically tested. 93 lastly, franciscan health only screened pregnant women who exhibited suspicious behaviors, had unexplained separation of the placenta from the uterine lining, had unexplained fetal growth issues, and did not seek prenatal care before birth in 2018.94 a positive maternal test resulted in automatic umbilical cord testing on the infant per the policy. 95 indiana law bars hospital providers from releasing the results of a verbal substance use screening, a urine test, or a blood test provided without the pregnant individual’s consent to law enforcement or dcs. 96 nevertheless, the indiana perinatal quality improvement collaborative (ipqic) recommends that providers perform an umbilical cord screen on all infants whose parent has a positive verbal screen based on a drug use questionnaire. 97 once the infant tests positive, the mandatory reporting statute is triggered and the hospital must report to dcs. 98 the mandatory reporting statute does not allow any discretion and healthcare providers are required to report the positive-thc result regardless of their interactions with the patient, the health of the infant, or their knowledge of safety of the home. 99 this lack of discretion is harmful because it places a blanket punishment on all families, regardless of the effect on the infant or safety of the home. 2. dcs policies the department of child services (dcs) governs how cases of marijuanapositive infants are investigated by the state of indiana. 100 all cases begin with a report of abuse to the dcs hotline. 101 a hotline report is statutory requirement if any individual has reason to believe a child is a victim of abuse or neglect. 102 hospital staff have a higher standard; any member of hospital staff must ————————————————————————————— 92. id. 93. id. 94. id. 95. id. 96. ind. code § 25-1-9-22 (2024). 97. deborah evert, indiana efforts to address perinatal substance use, ind. perinatal quality improvement collaborative 9 (aug. 27, 2019), https://www.ihaconnect.org/ resources/public/patient safety/2019 psu conference/ipqic community hn slides to share.pdf [https://perma.cc/58aa-vpfs]. 98. see ind. code § 31-33-5-1 (2024). 99. see id. 100. ind. code § 31-25-2-11 (2024). 101. see ind. code § 31-33-8-1(c) (2024); see also indiana child abuse and neglect hotline, ind. dep’t of child servs. https://www.in.gov/dcs/contact-us/child-abuse-and-neglecthotline/ [https://perma.cc/p5dg-2c9p] (last visited dec. 28, 2024). 102. ind. code § 31-33-5-1 (2024). https://perma.cc/p5dg-2c9p https://www.in.gov/dcs/contact-us/child-abuse-and-neglect https://perma.cc/58aa-vpfs https://www.ihaconnect.org indiana health law review [vol. 22:125 136 immediately notify dcs or law enforcement of suspected abuse. 103 there is no discretion permitted by law for hospital personnel or individuals to abstain from calling in a report even if they believe dcs involvement is not necessary. it would be beneficial for a provider to have discretion when to call in these situations because a marijuana-positive test does not equate to abuse. therefore, allowing the provider to use their best judgment based on their expertise and experience saves not only valuable dcs resources but protects the family from unnecessary intrusion by the agency. once the report is received by dcs, the department is required to make a prompt and thorough assessment. 104 once this assessment is completed and the family has been investigated, dcs will either substantiate the report if they believe enough evidence has been presented to support the allegations or unsubstantiate if the allegations are not supported by evidence. 105 the assessment manager who investigates the abuse must show by a preponderance of the evidence that the allegations are substantiated. 106 the dcs manual states that a single positive drug screen should not be considered an automatic chins, however, information relating to the impact of the drug use on the child and home environment should be used to make a determination on a case-by-case basis. 107 nevertheless, the dcs manual specifically excludes § 31-34-1-10 from this policy. 108 under the policy, a positive drug screen supports a substantiation for a drug born infant, encouraging case managers to ignore the coercive need for court intervention condition of the statute. 109 such broad language gives assessment workers wide discretion on whether or not chins would be found at the assessment stage. since every individual has different biases and attitudes towards marijuana use, unequal application of the law and treatment to the families occurs throughout the state and even within counties. once a report has been substantiated, a parent has thirty days after the notice of substantiation to request an administrative review of the assessment. 110 dcs will then notify the parent if their appeal will be heard at least ten days before ————————————————————————————— 103. id. § 2.5. 104. ind. code § 31-33-8-6 (2024). 105. id. § 12. 106. ind. dep’t of child servs., indiana department of child services child welfare policy: making an assessment finding 1 (2020) [hereinafter, making an assessment finding], https://www.in.gov/dcs/files/4.22-making-an-assessment-finding.pdf [https://perma.cc/h3w3-bg97]. 107. id. at 6. 108. ind. dep’t of child servs., indiana department of child services child welfare policy: drug screening in assessments 1 (2022) [hereinafter, drug screening in assessments], https://www.in.gov/dcs/files/4.40.pdf [https://perma.cc/4znw-53bp]. 109. see id. 110. ind. dep’t of child servs., indiana department of child services child welfare manual: administrative appeal hearings 3 (2013) [hereinafter, administrative appeal hearings], https://www.in.gov/dcs/files/2.05_administrative_appeal_hearings.pdf [https://perma.cc/av7g-v4uv]. https://perma.cc/av7g-v4uv https://www.in.gov/dcs/files/2.05_administrative_appeal_hearings.pdf https://perma.cc/4znw-53bp https://www.in.gov/dcs/files/4.40.pdf https://perma.cc/h3w3-bg97 https://www.in.gov/dcs/files/4.22-making-an-assessment-finding.pdf 2025] a recommendation for the indiana legislature 137 dcs’s chosen date of hearing. 111 the appeal is quasi-judicial and conducted “in the same manner as if it were preparing for a chins juvenile court fact finding hearing.” 112 administrative reviews very rarely happen after a substantiation. the quasi-judicial nature of the hearing makes it difficult for a parent to prepare on short notice without the aid of legal counsel. impoverished families are over forty times more likely to enter the child welfare system compared to middle class families 113 and many of these families will not have the financial resources to hire counsel to fight a substantiation. if a report is substantiated and dcs determines that juvenile court involvement is necessary, dcs files a chins petition. 114 at the initial hearing, the parent has the opportunity to admit or deny the allegations in the petition. 115 the court considers the parent’s testimony and all relevant evidence presented to determine whether the child will be found chins under the law. if the court finds that the child is not a chins, the child will be discharged and the substantiation will be removed from the parents’ record within ten working days.116 if chins is found, the court may order removal, coercive intervention, or a period of informal adjustment. after chins adjudication, the court will hold a dispositional hearing, which creates a safety plan and orders courtmandated services that must be completed by the parents. 117 commonly in cases of marijuana-positive infants, the court will order the mother to participate in random drug screening, which may range in frequency from twice a week to monthly depending on dcs’s recommendation. 118 3. judicial interpretation of § 31-34-1-10 there is no uniformity in how lower indiana courts respond to cases of marijuana-positive infants. juvenile courts have wide discretion during the chins adjudication process, which creates inconsistencies on how marijuana use is treated under the child abuse statutes. juvenile court judges in some counties will remove the child from mother’s care for prenatal marijuana use, 119 ————————————————————————————— 111. id. at 1. 112. id. at 4. 113. family and child well-being system: economic & concrete supports as a core component, chapin hall univ. chi. (apr. 2021), https://www.in.gov/dcs/files/economicsupports-deck.pdf [https://perma.cc/2wts-kuy2]. 114. ind. code § 31-33-14-1 (2024). 115. id. § 31-34-10-6. 116. id. § 31-33-26-15(a)(1). 117. id. § 31-34-19-1(a). 118. ind. dep’t of child servs., service standard indiana department of child services random drug testing, [hereinafter, random drug testing] https://www.in.gov/ dcs/files/27-random-drug-testing.pdf [https://perma.cc/69sh-uylq] (last visited sept. 28, 2024). 119. see h.g. v. ind. dep’t of child servs. (in re l.k.), no. 23a-jc-1249, 2024 ind. app. lexis 183, at *2 (ind. ct. app. 2024); see also d.v. v. ind. dep’t of child servs. (in re b.v.), https://perma.cc/69sh-uylq https://www.in.gov https://perma.cc/2wts-kuy2 https://www.in.gov/dcs/files/economic indiana health law review [vol. 22:125 138 while others will reject such arguments. 120 however, recent decisions of the indiana court of appeals demonstrate that mandatory dcs involvement in marijuana-positive infants should be reassessed. in 2015, the indiana court of appeals found that a showing of a marijuana-positive meconium test did not alone show an endangerment to the child, which satisfies the need for the coercive intervention of the court. 121 furthermore, in 2017, a separate panel of the indiana court of appeals held that a mother’s marijuana use two months before the birth of her infant did not alone satisfy prong two of section 31-34-1-1,122 requiring that dcs show the “child needs care, treatment, or rehabilitation that… is unlikely to be provided or accepted without coercive intervention of the court.” 123 the indiana court of appeals is clear: there must be a showing of “specific evidence that the marijuana itself or mother’s use of it present[s] a serious danger to the children,” 124 and mother’s use of marijuana during pregnancy is not considered sufficient evidence to satisfy this standard. 125 importantly, the sole issue of marijuana use, “whether isolated or habitual” is not enough to support a chins finding.126 although the indiana court of appeals has held marijuana use does not alone constitute a chins adjudication, dcs and juvenile courts still continue to use a positive marijuana test to justify family intervention. 127 there appears to be a trend in which some courts use the positive marijuana test as their primary reason to be involved in impoverished families who do not satisfy the standard to fit into other abuse or neglect statutory categories. in 2015, judge baker writing for the indiana court of appeals stated: “the mere fact of an unemployed parent does not make a chins. the mere fact of a family on food stamps does not make a chins. even the mere fact of a family living in a shelter while seeking stable housing does not make a chins.” 128 however, the factors listed by judge baker in his 2015 opinion are still used by dcs to justify a chins petition. for example, dcs filed a chins petition ————————————————————————————— 110 n.e.3d 437, 439 (ind. ct. app. 2018) (reversing trial court finding of chins and removal order for prenatal marijuana use). 120. see j.j. v. ind. dep’t of child servs. (in re k.s.), 78 n.e.3d 740, 745 (ind. ct. app. 2017). 121. a.m. v. ind. dep’t of child servs. (in re s.m.), 45 n.e.3d 1252, 1256 (ind. ct. app. 2015). 122. j.j., 78 n.e.3d at 745. 123. ind. code § 31-34-1-1 (2017). 124. a.m. v. ind. dep’t of child servs. (in re ad.m.), 103 n.e.3d 709, 714 (ind. ct. app. 2018). 125. id. (citing a.m. v. ind. dep’t of child servs. (in re s.m.), 45 n.e.3d at 1255). 126. e.t. & t.t. v. ind. dep’t of child servs., no. 21a-jc-203, 2021 ind. app. lexis 532, at *20 (ind. ct. app. june 23, 2021). 127. see j.j., 78 n.e.3d at 745 (reversing a lower court’s chins adjudication for mother’s marijuana use and unstable housing situation). 128. a.m. v. ind. dep’t of child servs. (in re s.m.), 45 n.e.3d 1252, 1256 (ind. ct. app. 2015). 2025] a recommendation for the indiana legislature 139 against a mother predominantly for her marijuana use, a single incident of domestic violence between mother and father, and having a cluttered home with sporadic electricity outages. 129 the court of appeals reversed the lower court’s chins adjudication because the mother had already remedied the home and domestic violence issues before the chins petition was even filed by dcs. 130 this case illustrates that dcs continues to substantiate on marijuana cases, even after the court of appeals has rejected such measures. another example is a case where an infant tested positive for marijuana at birth and the mother alleged, she did not know she was pregnant until she was twenty-six weeks along and immediately stopped use once she discovered her pregnancy. 131 although the family case manager found that there was adequate food, working utilities, and appropriate cleanliness in the home, there were seven people living in the apartment. 132 the living arrangements combined with the family case managers’ “number one issue” of the marijuana positive birth led to dcs filing a chins petition. 133 this 2009 panel of the indiana court of appeals ultimately upheld the chins adjudication. 134 judge may of the indiana court of appeals served on the panel for this 2009 case and also served on the 2017 panel which heard j.j. v. indiana department of child service (in re k.s.), a case that reached the opposite conclusion and held mother’s use of marijuana during pregnancy is not justification to support a chins adjudication. 135 judge may’s decisions in these two cases reflect the indiana court of appeals’ changing attitude towards this issue and further illustrates dcs’s continued efforts to involve the department in the families of marijuana-positive infants. even though the court of appeals has clearly stated that marijuana-use alone during pregnancy is not enough to justify dcs involvement, dcs will remove a child to foster care for sole marijuana use. in 2022, madison county, indiana dcs removed an infant and placed it in foster care due to the sole issue of mother’s use of thc products during pregnancy. 136 furthermore, the decision to place the child in foster care occurred after the mother testified that she used legal delta-8 purchased in indiana gas stations. 137 the court of appeals in their 2024 opinion reversed the trial court’s chins finding. 138 the court rejected dcs’s position and held that dcs provided no evidence on how the child was endangered by the marijuana use nor any evidence why the child needed the ————————————————————————————— 129. a.m. v. ind. dep’t of child servs. (in re ad.m.), 103 n.e.3d at 711–12. 130. id. at 715. 131. in re b.c. v. marion cnty. dep’t of child servs., no. 49a05-0806-jv-320, 2009 ind. app. lexis 187, at *2 (ind. ct. app. jan. 20, 2009). 132. id. at *3. 133. id. 134. id. at *12–13. 135. 78 n.e.3d 740, 745 (ind. ct. app. 2017). 136. h.g. v. ind. dep’t of child servs. (in re l.k.), no. 23a-jc-1249, 2024 ind. app. lexis 183, at *2–4 (ind. ct. app. feb. 19, 2024). 137. id. 138. id. at *11. indiana health law review [vol. 22:125 140 coercive intervention of the court. 139 this separate panel of the court of appeals relied on judge baker’s 2015 precedent: a “[m]other’s ingestion of thc while pregnant and thc in the [c]hild’s umbilical cord at birth do not alone demonstrate [the] [c]hild is seriously endangered.” 140 iii. analysis a. why is this legal scheme harmful? 1. stress on the family structure a positive thc screen triggers dcs involvement, causing harm to the mother, infant, and outside family. although the indiana court of appeals has held that a thc-positive infant does not solely support a chins adjudication, dcs continues to substantiate such cases 141 and send the families to court. 142 when a report of neglect or abuse is substantiated on, this means that the agency has authenticated their preliminary finding of abuse or neglect. 143 once a person receives a substantiation, they can no longer adopt a child, hold a teaching license, work in a childcare facility, or supervise children in an informal setting such as a school field trip.144 additionally, entering foster care can be detrimental to a child’s mental state.145 in the first years of life, children depend on stable caregivers to regulate “their physiology, attention, behavior, and emotions.” 146 young children who experience disruptions in caregiving stability can exhibit issues in behavioral function later in life.147 during the first three to four years of life, a young child’s brain develops its personality traits, learning processes, stress coping skills, and emotional regulation processes. 148 stress from removal, even in a young child ————————————————————————————— 139. id. 140. id. at *7–8. 141. see in re a.a. v. ind. dep’t of child servs., no. 21-a-jc-1671, 2022 ind. app. lexis 19, at *2 (ind. ct. app. jan. 13, 2022) (discussing a prior substantiation on the mother for prenatal marijuana use). 142. see ind. code § 31-33-8-12 (2024). 143. id. 144. dcs substantiation indiana, banks & brower, llc (sept. 10, 2017) https://banksbrower.com/2017/09/10/dcs-substantiation-indiana/ [https://perma.cc/wl2n-8f yx]. 145. am. acad. of pediatrics comm. on early childhood, adoption, and dependent care, developmental issues for young children in foster care, 106 pediatrics 1145, 1146 (2000). 146. mary dozier et al., infants and toddlers in foster care, 7 child dev. persps. 166, 167 (2013). 147. id. at 168.; see also cynthia v. healey & philip a. fisher, children in foster care and the development of favorable outcomes, 33 child youth serv. rev. 1822, 1832 (2012). 148. am. acad. of pediatrics comm. on early childhood, adoption, and dependent care, supra note 145, at 1145. https://perma.cc/wl2n-8f https://banksbrower.com/2017/09/10/dcs-substantiation-indiana 2025] a recommendation for the indiana legislature 141 or infant, can impair this brain development. 149 due to the potential severe developmental consequences, a child should not be removed from his or her parent’s care unless the potential abuse or neglect from the parent outweighs the potential developmental consequences resulting from removal. racial disparities also play a role in an analysis of harm from child welfare involvement. the child welfare services system throughout the united states more often negatively impacts impoverished, people of color.150 black children are more likely to experience both child abuse investigations and removal from their parents compared to white children. 151 24 percent of child abuse or neglect reports were made for black children, and black children account for 21 percent of those entering the foster care system. 152 rates of removal to the foster care system are even higher for indigenous children; an indigenous mother is four times more likely to have their children removed compared to non-indigenous parents. 153 child services involvement disrupts the family structure through “changes in residence, parental employment, and social support” which negatively impacts child development by causing stress and conflicts among parents. 154 parents of removed children also experience higher rates of “depression, substance use, physician visits for mental illness, and prescriptions of psychotropic medications.” 155 overall, child services involvement harms both the parents and the infants involved, and these harms should be avoided when the child is not in danger of abuse or neglect. 156 even after the court of appeals rejected chins adjudication for in-utero marijuana exposure in 2015, removal to foster care is still currently an option for dcs in such cases. in 2022, dcs in madison county, indiana removed an infant and placed the baby in foster care due to the sole issue of mother’s use of thc products during pregnancy. 157 furthermore, the decision to place the child in foster care occurred after the mother testified that she used legal delta-8 purchased in indiana gas stations. 158 the court of appeals in their 2024 ————————————————————————————— 149. id. 150. us: child welfare system harms families, hum. rts. watch (nov. 17, 2022, 12:01 am), https://www.hrw.org/news/2022/11/17/us-child-welfare-system-harms-families [https:// perma.cc/6nq9-zj7s]. 151. id. 152. id. 153. id. 154. sharon h. bzostek & lawrence m. berger, family structure experiences and child socioemotional development during the first nine years of life: examining heterogeneity by family structure at birth, 54 demography 513, 516 (2017). 155. kathleen s. kenny, mental health harm to mothers when a child is taken by child protective services: health equity considerations, 63 can. j. psychiatry 304, 304 (2018). 156. see a.m. v. ind. dep’t of child servs. (in re s.m.), 45 n.e.3d 1252, 1256–57 (ind. ct. app. 2015) (stating that the indiana department of child services should not focus its time and effort on cases of marijuana-positive infants). 157. h.g. v. ind. dep’t of child servs. (in re l.k.), no. 23a-jc-1249, 2024 ind. app. lexis 183, at *2–4 (ind. ct. app. feb. 19, 2024). 158. id. https://www.hrw.org/news/2022/11/17/us-child-welfare-system-harms-families indiana health law review [vol. 22:125 142 unpublished opinion reversed the trial court’s chins finding. 159 the court rejected dcs’s position and held that dcs provided no evidence on how the child was endangered by the marijuana use nor any evidence why the child needed the coercive intervention of the court. 160 this separate panel of the court of appeals relied on judge baker’s 2015 precedent: a “[m]other’s ingestion of thc while pregnant and thc in [the] [c]hild’s umbilical cord at birth do not alone demonstrate that [the] [c]hild is seriously endangered.” 161 2. physician-patient distrust the hospital policies on drug testing disadvantage low-income people of color. 162 since iu health and franciscan health do not universally screen mothers, the hospital staff independently determines which individuals are suspected drug users. a 2023 published study found that 43.3% of all drug positive infants were positive solely for thc at a midwest hospital. 163 between 2014-2020, hospital staff ordered drug tests for black newborns at a rate of 7.3% compared to just 1.9% of white newborns even though 71.6% of those admitted for delivery to the hospital were white. 164 the hospital’s bias for drug testing black mothers is not unique. after being admitted for delivery, black women are at least 1.5 times more likely to be drug tested than non-black women. 165 race is not associated with whether a mother will test positive for an illegal drug. 166 nevertheless, black mothers are tested at much higher rates than white mothers. iu health and franciscan health’s policies allowing for hospital staff to independently determine which parents are drug screened furthers the disparity. human biases and racist attitudes towards black families are likely to contribute to the decision to drug test a pregnant parent or infant without a set procedure for when these individuals are drug tested. 167 black, pregnant women “experience maltreatment and preventable adverse outcomes in [maternal] healthcare settings at higher rates than white women.” 168 furthermore, black parents are four times more likely to be reported to child protective services ————————————————————————————— 159. id. at *11. 160. id. 161. id. at *7–8. 162. see generally supra sec. d1. 163. sebastian schoneich et al., incidence of newborn drug testing and variations by birthing parent race and ethnicity before and after recreational cannabis legalization, 6 jama network open 1, 4–6 (2023). 164. id. at 5. 165. hillary veda kunins et al., the effect of race on provider decisions to test for illicit drug use in the peripartum setting, 16 j. women’s health 245, 255 (2007). 166. id. 167. see generally hayley r. price et al., screening pregnant women and their neonates for illicit drug use: considerations of the integrated technical, medical, ethical, legal, and social issues, 9 frontiers pharmacology 961, 961 (2018). 168. brittany d. chambers et al., clinicians’ perspectives on racism and black women’s maternal health, 3.1 women’s health reps. 476, 480 (2022). 2025] a recommendation for the indiana legislature 143 from a hospital provider compared to white parents. 169 hospital policies which allow for staff to independently determine who will be drug tested result in high harm for black parents and allows for black women to face punitive consequences for maternal marijuana use even though rates of use are similar among racial groups.170 an additional consequence of the current legal and policy framework is patient mistrust of medical providers. physician mandatory reporting creates an “adversarial relationship” between the provider and patient and encourages the patient to either not be truthful about their substance use or avoid prenatal care altogether. 171 pregnant mothers who are using marijuana are put in a difficult position, they can: (1) be honest with their doctors and have their infants unconsensually drug tested; (2) refuse prenatal care and risk adverse health outcomes; or (3) lie to their providers about their substance use. dishonesty is the only method of ensuring the infant is not drug tested based on the mother’s interactions with their medical providers. it is necessary to foster trust between doctor and patient to promote the health and welfare of both mother and infant. 172 prenatal care “greatly reduces” risks of low birth weight and prematurity, 173 two health risks with potential connections to prenatal marijuana use. 174 the american college of obstetricians and gynecologists strongly recommends healthcare providers counsel all pregnant individuals about the potential negative effects of maternal marijuana use;175 however, indiana providers are unable to follow their guidance due to the mandatory reporting law. if the physician learns of marijuana use and counsels the pregnant patient to abstain, the physician must still drug test the infant under the hospital’s policies. such an act breaks the parent’s confidence and trust based on their disclosure. dismantling the punitive system of maternal drug testing will improve access to prenatal care and substance use treatment which will result in improved health outcomes for both the mother and infant involved.176 ————————————————————————————— 169. id. at 481. 170. am. coll. obstetricians & gynecologists, opposition to criminalization of individuals during pregnancy and postpartum period statement of policy (dec. 2020), https://www.acog.org/clinical-information/policy-and-position-statements/statements-ofpolicy/2020/opposition-criminalization-of-individuals-pregnancy-and-postpartum-period [https://perma.cc/6d64-nn43]. 171. am. coll. obstetricians & gynecologists committee on health care for underserved women, substance abuse reporting and pregnancy: the role of the obstetrician-gynecologist: committee opinion 473 (jan. 2011), https://www.acog.org/ clinical/clinical-guidance/committee-opinion/articles/2011/01/substance-abuse-reporting-andpregnancy-the-role-of-the-obstetrician-gynecologist [https://perma.cc/m9pd-ha2z]. 172. id. 173. id. 174. marroun et al., supra note 13, at 1181. 175. comm. obstetric prac., supra note 12, at 207. 176. price et al., supra note 167, at 961. https://perma.cc/m9pd-ha2z https://www.acog.org https://perma.cc/6d64-nn43 https://www.acog.org/clinical-information/policy-and-position-statements/statements-of indiana health law review [vol. 22:125 144 3. dcs burden the financial costs of the child welfare system is immense. yearly across the united states, direct public expenditures by state and local child welfare agencies total thirty-three billion dollars. 177 in indiana, dcs requested $931,492,447 from the state to continue their operations for the 2025 year. 178 the majority of this budget is used just to provide services for families in the child welfare system. 179 furthermore, the dcs system faces numerous challenges. a 2018 report from child welfare policy and practice group (cwg)180 found a multitude of issues plaguing indiana dcs. in this report, the group found indiana dcs has an “exceptionally high rate of court involvement”, high staff caseloads, and uneven interpretation and implementation of policies across counties. 181 specifically, the number of court involved cases is double the national average, indiana accepts more abuse and neglect reports than the national average, and in 2017 dcs spent $24,933,487 just on drug testing and supplies. 182 the group recommended broad legislation to solve the problems, however, much was not implemented. for example, it was recommended the indiana legislature “exclude neglect which is solely based on poverty or limited, one-time lapses in parental judgement . . . .” 183 this has not been implemented by the indiana legislature as of 2023. currently, there is no pending legislation in the 2024 session to address this issue. furthermore, the report identified high staff caseloads and a major concern for the agency. 184 although staff turnover rate dropped in 2019 after the cwg report, it currently is on the rise once more. 185 in 2022, dcs identified staffing as still a major concern due to losing 774 family case managers between january to november 2022 alone. 186 in the 2023 fiscal ————————————————————————————— 177. family and child well-being system: economic & concrete supports as a core component, supra note 113, at 14. 178. ind. dep’t child servs., dcs state budget committee presentation 16 (2022), https://www.in.gov/sba/files/1.-dept-of-child-services-budget-committee-presentation.pdf [https://perma.cc/u4bq-dg3k]. 179. id. 180. the cwg is a private, non-profit organization which assists child welfare agencies throughout the country to create, design, and manage organizational changes to improve the agencies’ outcomes and practices. see generally the child welfare policy and practice group, cause iq, https://www.causeiq.com/organizations/the-child-welfare-policy-and-practice-group, 721364474/ [https://perma.cc/8ryu-3vbj] (last visited mar. 7, 2024). 181. child welfare policy & practice group, evaluation of the indiana department of child services 5 (2018). 182. id. at 7. 183. id. at 7, 89. 184. id. at 30. 185. editorial: case manager turnover remains a problem at dcs, daily j. (dec. 7, 2023), https://dailyjournal.net/2023/12/07/editorial-case-manager-turnover-remains-a-problem-at-dcs/ [https://perma.cc/2kxm-acj5]. 186. ind. dep’t child servs., supra note 178, at 13. https://perma.cc/2kxm-acj5 https://dailyjournal.net/2023/12/07/editorial-case-manager-turnover-remains-a-problem-at-dcs https://perma.cc/8ryu-3vbj https://www.causeiq.com/organizations/the-child-welfare-policy-and-practice-group https://perma.cc/u4bq-dg3k https://www.in.gov/sba/files/1.-dept-of-child-services-budget-committee-presentation.pdf 2025] a recommendation for the indiana legislature 145 year, indiana dcs saw a turnover of over one third of its statewide staff. 187 the cwg report also identified attitudes of family case managers, attorneys, and others in the department which reflected an “increased prevalence of the assumption that a parent who uses any type of substance, particularly any that is illegal, is a ‘bad person’ and unsuitable as a parent.” 188 the group’s reviewers frequently heard references from dcs staff regarding a substance’s illegal status when determining case outcomes rather than discussions of impairment or child endangerment. 189 furthermore, many case managers specifically stated that they felt dcs takes an “aggressive approach” to parental marijuana use when the same focus is not used for parental alcohol use. 190 although case managers have identified dcs cultural issues which results in aggressive and unfair pursuit of marijuana cases in 2018, the state has not implemented any comprehensive reform to solve the issue. furthermore, prenatal marijuana use is still a large factor in chins adjudications in the state, five years after the cwg report was released. 191 it is unclear why the indiana legislature will not take action to lessen the burden on dcs regarding marijuana. staffing and budget issues are high level concerns for the agency, therefore, removing marijuana use as an neglect/abuse indicator would free up time and resources for dcs staff to focus on more pressing cases. furthermore, the indiana court of appeals is clear in its precedent that marijuana use will not support a chins adjudication on appeal. the resources exerted by dcs to involve themselves in prenatal marijuana cases wastes the time and energy of the already over-burdened case managers, especially considering many of these cases will lose on appeal. iv. possible solutions to reduce harm of the statutory scheme a. how do other states approach this issue? currently, twenty-four states have legalized recreational marijuana, and thirty-eight states have legalized medicinal marijuana. 192 however, even legalized states differ in their approach to prenatal marijuana use. indiana’s surrounding states of ohio, illinois, and kentucky illustrate three different ————————————————————————————— 187. editorial: case manager turnover remains a problem at dcs, supra note 185. 188. ind. dep’t child servs., supra note 178, at 55. 189. id. 190. id. 191. see l.h. v. ind. dep’t of child servs., no. 22a-jc-730, 2022 ind. app lexis 1153, at *10 (ind. ct. app. sept. 30, 2022) (explaining mother’s prenatal marijuana use and continued use post birth was a factor in her child’s removal); see also mother v. ind. dep’t of child. servs. (in re of f.f.,), no. 23a-jt-494, 2023 ind. app. lexis 1430, at *2 (ind. ct. app. 2023) (discussing the original chins petition which alleged prenatal marijuana use as its first factor supporting removal). 192. state medical cannabis laws, supra note 3. indiana health law review [vol. 22:125 146 approaches for child welfare services involvement in marijuana-positive infants. ohio legalized recreational marijuana on november 7, 2023. 193 in ohio, child welfare services is statutorily barred from filing a complaint against a mother using a controlled substance during pregnancy if the mother: (1) enrolled in a drug treatment program before the twentieth week of pregnancy; (2) successfully completed the program or is in the process of successful completion; and (3) maintained her regularly scheduled appointments and prenatal care as recommended by a physician. 194 furthermore, there is no comparable “trace amount” of a controlled substance language in the ohio child abuse statutes and ohio child welfare services has more discretionary power when choosing to file complaints compared to indiana. in illinois, individuals who are mandatory child abuse reporters may report a pregnant individual with substance use disorder to the department of human services for treatment. 195 although illinois legalized recreational marijuana in 2019,196 the legislator includes “a spectrum of persistent and reoccurring problematic” cannabis use which results in “clinically significant impairment or distress” within their definition of substance use disorder. 197 however, the illinois cannabis regulation and tax act expressly prohibits cannabis use from being the sole factor supporting an action by the child welfare agency. 198 nevertheless, there are reports of judges and child welfare agency actors continuing to use marijuana as primary justification for child welfare agency involvement. 199 lastly, kentucky, a state which marijuana is illegal, includes in their definition of child abuse or neglect a parent which “creates or allows to be created a risk of physical or emotional injury… to the child by other than accidental means.” 200 however, there is no trace amount language or reference to parental substance use in the statute. nevertheless, kentucky courts have extended this definition of abuse to prenatal marijuana use. 201 this statute is broader than indiana’s because it does not expressly include prenatal substance use, allowing child welfare workers to use their discretion during child abuse ————————————————————————————— 193. samantha hendrickson & julie carr smith, adults can now legally possess and grow marijuana in ohio – but there’s nowhere to buy it, ap news (dec. 7, 2023, 6:11 pm), https://apnews.com/article/ohio-legalized-recreational-marijuanaeb7fb8bc24d5f04e35cae89f491b3995 [https://perma.cc/r2nz-a2qr]. 194. ohio rev. code ann. § 2151.26(b) (1)-(3) (lexisnexis 2017). 195. 325 ill. comp. stat. 5/7.3b (2019). 196. 410 ill. comp. stat. 705/1-5 (2019). 197. 20 ill. comp. stat. 301/1-10 (2019). 198. 410 ill. comp. stat. 705/10-30 (2019). 199. jaye r. lindsay, illinois: marijuana consumers still face discrimination in family court, norml (feb. 19, 2021), https://norml.org/blog/2021/02/19/illinois-marijuanaconsumers-still-face-discrimination-in-family-court/ [https://perma.cc/97x9-nqjd]. 200. ky. rev. stat. ann. § 600.020(a)(1)(2) (2022). 201. see c.j.m. v. cabinet for health & family servs., 389 s.w.3d 155, 155-56 (ky. ct. app. 2012) (affirming a father’s termination of parental rights when the original complaint was due to the mother’s prenatal marijuana use). https://perma.cc/97x9-nqjd https://norml.org/blog/2021/02/19/illinois-marijuana https://perma.cc/r2nz-a2qr https://apnews.com/article/ohio-legalized-recreational-marijuana 2025] a recommendation for the indiana legislature 147 investigations. indiana has uniquely rigid child abuse definitions compared to many other areas of the united states. 202 in fact, twenty-six states have no specific statute defining prenatal substance use as child abuse or neglect. 203 in these twenty-six states, the legislators have chosen to generally “afford discretion to individual providers, hospitals, and other policy implementers to determine whether abuse is suspected,” 204 rather than automatically requiring a punitive approach. b. hospital policy reform hospitals have the opportunity to be at the forefront of marijuana reform by amending their internal policies on marijuana-positive infants. hospitals can either create a universal drug testing system, ban maternal drug testing, or counsel women regarding the harms of marijuana use during pregnancy whilst also working within the confines of section 31-34-1-10(c) and the mandatory reporting statute.205 one solution to decrease racism and biases, which lead to black mothers being drug tested at higher rates, is to require all indiana hospitals to drug test every individual who is admitted for delivery; community health currently follows this type of policy. 206 although universal drug testing would create an equitable system in which everyone, regardless of race, is treated the same in the hospital, this policy choice would heighten other types of harm to the parent and family. the american college of obstetricians and gynecologists opposes universal, mandated drug testing for pregnant women because the drug testing “disrupts bodily autonomy of the pregnant person and their newborn and is inconsistent with treating substance use disorder.” 207 a universal drug testing policy would increase the harm to the family structure as it would cause more maternal marijuana use to be discovered and increase the reports to dcs. furthermore, a universal system would not solve the issue of physician-patient mistrust because pregnant individuals will continue to “engage in behavior to avoid detection, including not presenting for prenatal care and attempting to deliver outside the hospital environment.” 208 the risk of increasing harm from dcs involvement and encouraging unsafe prenatal and labor care makes universal drug screening an unwise policy decision. a second potential solution is to ban maternal drug testing altogether. ————————————————————————————— 202. see ga. code ann. § 15-11-2 (2021) (georgia has a similar statute to indiana which defines prenatal abuse in part as the “presence of a controlled substance or a metabolite thereof in the newborn’s body, blood, urine, or meconium that is not the result of medical treatment”). 203. alexander d. mccourt et al., development and implementation of state and federal child welfare laws related to drug use in pregnancy, 100 milbank q. 1076, 1076 (2022). 204. id. 205. ind. code § 31-33-5-1 (2024). 206. criscuolo, supra note 91. 207. am. coll. obstetricians & gynecologists, supra note 170. 208. price et al., supra note 167, at 961. indiana health law review [vol. 22:125 148 banning maternal drug testing would solve the issues of dcs involvement, medical racism, and physician-patient mistrust because the hospital will never discover the marijuana use. furthermore, an overall ban would conform to the college of obstetricians and gynecologists recommendation that health care providers encourage self-reporting substance use rather than utilizing drug testing procedures. 209 maternal drug testing supports a culture of fear surrounding prenatal health and banning the practice would encourage patients to seek prenatal care and increase healthy outcomes for the pregnant parent and infant in the context of maternal marijuana use. however, banning maternal drug testing would not necessarily create the best outcomes for all pregnant mothers and infants. although marijuana has not been connected to adverse health outcomes for infants, there are many other types of illegal substances which can cause severe health issues which healthcare workers must be aware of before birth. for example, infants exposed to methamphetamine have an increased chance of low birth weight, growth issues, and preterm delivery. 210 furthermore, methamphetamine-exposed infants have a high chance of post-birth withdrawal systems including poor muscle control, poor appetite, jittery temperament, sleeping issues, and/or trouble breathing. 211 in cases of methamphetamine exposure, it is critical that healthcare providers know the infant is methamphetamine-positive to provide care which could be lifesaving to the child. 212 banning maternal drug testing would prevent care for other types of drug exposure, so the harms associated with non-marijuana drug exposure potentially outweigh the harms of involvement for marijuana. the last solution is for hospitals to amend their policies and counsel all pregnant patients about marijuana use without asking whether or not they partake in the substance. the hospitals can create a pamphlet and a small discussion about the potential risks of marijuana use and require that all patients are counseled about the risk during their prenatal appointments. if the healthcare providers are clear at the beginning of an appointment that they do not want an admission of use but only wish to provide resources and information regarding marijuana, this will not trigger the mandatory reporting statute. this solution will solve the issues of dcs involvement, medical racism, and physician-patient mistrust since all patients, regardless of race, will receive the same information and counseling. furthermore, it gives pregnant individuals an opportunity to learn about the potential risks of infant marijuana-exposure without being forced to admit use; however, without substantial change to hospital drug testing policies, this solution will not necessarily solve the inequalities in testing procedures. pregnant black mothers will still be tested at ————————————————————————————— 209. am. coll. obstetricians & gynecologists, supra note 170. 210. mother to baby fact sheets methamphetamine, mothertobaby (jan. 2024) https://mothertobaby.org/fact-sheets/methamphetamine/ [https://perma.cc/cs89-x6kz]. 211. id. 212. id. https://perma.cc/cs89-x6kz https://mothertobaby.org/fact-sheets/methamphetamine 2025] a recommendation for the indiana legislature 149 higher rates than white individuals under individualized drug testing determination policies.213 however, all pregnant mothers will receive the opportunity to learn about marijuana and decide whether to stop use without giving the hospital staff opportunity to suspect use via the patient’s admission or inquiries into the potential harms of maternal marijuana use. although hospitals can amend their internal policies, such solutions do not change the root of the issue: state involvement. hospitals are the first step in the cycle of the state’s involvement for maternal marijuana use, however, hospitals cannot completely change the system through their actions. the only way to ensure dcs does not involve themselves in marijuana-positive infants is through legislative action. c. dcs reform dcs also has opportunity to reform their internal practices to decrease rates of involvement in marijuana-positive infants. a potential solution is for dcs to focus solely on the need for the coercive intervention condition of the statute when investigating such cases. 214 although this condition is supposed to be highly considered when investigating all cases, there is a lack of uniformity among the department’s case and assessment managers in what constitutes the need for coercive intervention. current dcs procedure states, “[w]ith the exception of ic 31-34-1-10, [a] decision to substantiate or unsubstantiate an allegation should not be based solely on the existence or absence of substance.”215 this policy in itself supports the practice of substantiating all cases of drug-positive infants under section 31-34-1-10 and ignores the coercive intervention requirement under the code. instead of promoting a policy of substantiating all cases of drug-born infants, dcs could create a policy which emphasizes a need to show how the prenatal drug use creates an unsafe environment for the child. such policy would more accurately reflect the requirements under the statute, align with the indiana court of appeals opinions, and help promote the best interests of the child. however, such policy would not necessarily create uniform procedures throughout the state since different case and assessment managers in different offices may have opposing views on what conditions constitute coercive intervention. dcs needs clear direction from the indiana legislature expressly excluding marijuana-positive infants from the statutory definition of a child in need of services to ensure that all offices throughout the state are treating such cases in a consistent manner. ————————————————————————————— 213. see criscuolo, supra note 91. 214. ind. code § 31-34-1-10 (2024). 215. drug screening in assessments, supra note 108, at 1 (emphasis added). indiana health law review [vol. 22:125 150 d. amendment to the statute there are two possible solutions to reduce the harm of the state’s involvement in marijuana-positive infants through legislative action. firstly, indiana could amend section 31-34-1-10(1)(c) to specifically exclude marijuana from the substances included in the definition of abuse or neglect. under this solution, the statute section would read: (1) a child is a child in need of services if: . . . (c) any amount, including a trace amount, of a controlled substance, a legend drug, or a metabolite of a controlled substance or legend drug in the child’s body, including the child’s blood, urine, umbilical cord tissue, or meconium, 216 excluding the presence of any amount, including a trace amount, of marijuana or other forms of delta-9-tetrahydrocannabinol (thc). amending the statute to exclude marijuana would be the simplest solution in reducing the harm from state involvement in marijuana-positive infants. one benefit of such a solution is that this language only affects in-utero marijuana exposure rather than a complete overhaul of how all controlled substances are treated under section 31-34-1-10. adding a marijuana exception would ensure that marijuana-positive infants are excluded from the statute, thereby not triggering hospital mandatory reporting laws 217 and ending any form of statutorily required dcs involvement in affected families. however, such an amendment would rigidly exclude marijuana from any dcs involvement no matter the outcomes. although marijuana has no proven connection to any infant adverse health outcomes, 218 future research may change the current understanding of marijuana’s effects during pregnancy. if so, a rigid exclusion of marijuana from the statute may become problematic if evidence of injury to the child is discovered. furthermore, laws relating to marijuana traditionally fail in indiana and any statute aiming to relax restrictions on the substance will most likely be met with resistance from indiana governor holcomb and certain members of the indiana legislature. 219 a second possible amendment to section 31-34-1-10 would be to change the statute back to its original pre-1997 version. this language would read: ————————————————————————————— 216. ind. code § 31-34-1-10(1)(c) (2024). 217. ind. code § 31-33-5-1 (2024). 218. see comm. obstetric prac., supra note 12, at 206–07; see also metz et al., supra note 56, at 484. 219. see indiana marijuana laws, indiana cannabis information (2023), https://indiana cannabis.org/laws [https://perma.cc/9h69-a9xd]; see also brittany carloni & kayla dwyer, ohio voted to legalize recreational marijuana. why indiana is unlikely to do the same, indystar (nov. 9, 2023 5:18 am), https://www.indystar.com/story/news/local/2023/11/09/ indiana-unlikely-legalize-recreational-marijuana-despite-ohio-vote/71503838007/ [https:// perma.cc/6has-va2c]. https://www.indystar.com/story/news/local/2023/11/09 https://perma.cc/9h69-a9xd https://cannabis.org/laws https://indiana 2025] a recommendation for the indiana legislature 151 a child is a child in need of services if: . . . (1) the child is born with: (a) fetal alcohol syndrome (b) an addiction to a controlled substance or a legend drug; or (2) the child: (a) has an injury; (b) has abnormal physical or psychological development; or (c) is at a substantial risk of a life threatening condition that arises or is substantially aggravated because the child’s mother used alcohol, a controlled substance, or a legend drug during pregnancy. . . .220 repealing section 31-34-1-10 and replacing it with the pre-1997 code section ensures that the harm element of the mother’s marijuana use is given great weight by dcs. under this language, the mere presence of thc in the infant’s system is not enough to satisfy any section of the statute. the infant must be born addicted to marijuana, which is not scientifically possible, 221 or have developmental issues due to the marijuana use. 222 returning to this statutory language could potentially decrease the amount of families referred to dcs for marijuana-positive infants because marijuana has not been directly connected to adverse developmental outcomes nor infant addiction and withdrawal symptoms. 223 furthermore, this language allows for marijuanapositive infants born with health issues to potentially be considered chins if future scientific research finds developmental issues from in-utero marijuana exposure. nevertheless, the pre-1997 code section is not a perfect solution. firstly, the language does not reflect the modern medical and scientific precision of the current language of section 31-34-1-10. section 31-34-1-10 includes neonatal abstinence syndrome and types of drug testing procedures in its language, 224 which informs healthcare providers of what types of tests and types of disorders should be included under the statute. furthermore, the term “addiction” is not defined in the statute. currently, healthcare providers consider an infant “addicted” to a substance if the infant suffers from neonatal abstinence syndrome. 225 however, without a clear definition of “addiction” under the statute, interpretations of what constitutes addiction could result in nonuniform application of the statute depending on the healthcare provider, dcs assessment worker, or judge involved. ————————————————————————————— 220. ind. code § 31-6-4-3.1 (1996) (replaced with ind. code § 31-34-1-10 (2024)). 221. shukla & doshi, supra note 11. 222. ind. code § 31-6-4-3.1 (1996) (replaced with ind. code § 31-34-1-10 (2024)). 223. see comm. obstetric prac., supra note 12, at 206–07. 224. ind. code § 31-34-1-10 (2024). 225. neonatal abstinence syndrome, stan. med. childs. health, https://www. stanfordchildrens.org/en/topic/default?id=neonatal-abstinence-syndrome-90-p02387 [https:// perma.cc/3uhh-7nld] (last visited sept. 29, 2024). https://www indiana health law review [vol. 22:125 152 v. proposal the state’s punitive approach towards prenatal marijuana use is neither decreasing the marijuana-positive births nor protecting the best interests of the child. amending the code to exclude marijuana would promote honesty between patients and doctors, dcs efficiency, and healthy family outcomes. furthermore, an amendment to section 31-34-1-10(c) excluding marijuana would end the requirement that healthcare providers must report marijuanapositive infants and allow them vital discretion in determining the needs of the child and family. in order to exclude marijuana while maintaining the majority of the statute’s language, the amended statute should read: (1) a child is a child in need of services if: . . . (c) any amount, including a trace amount, of a controlled substance, a legend drug, or a metabolite of a controlled substance or legend drug in the child’s body, including the child’s blood, urine, umbilical cord tissue, or meconium, 226 excluding the presence of any amount, including a trace amount, of marijuana or other forms of delta-9-tetrahydrocannabinol (thc). maintaining the majority of the language of the current section 31-34-110(c) section ensures that other controlled substances which are scientifically proven to cause harm are still included in the statute. furthermore, it allows dcs to focus its limited time and resources on cases of heroin, methamphetamine, fentanyl, and other dangerous drugs whose use substantially creates a high risk of abuse for the child after birth. lastly, this proposed amendment would end the lower court’s involvement in marijuana-positive infants and save the court’s time, money, and resources when these cases are usually reversed upon appeal. nevertheless, an amendment excluding marijuana is likely to be met with push back from the indiana legislature. bills regarding marijuana’s legalization and decriminalization have been on the indiana legislative docket for years but have never advanced, even when there has been bipartisan support. 227 furthermore, current indiana governor eric holcomb strongly opposes marijuana’s legalization because the federal government classifies it as a schedule 1 narcotic. 228 although holcomb’s tenure as indiana’s governor will end in november 2024, his opinion on indiana’s legalization of marijuana is shared by other indiana politicians. in the 2024 legislative session, a bipartisan ————————————————————————————— 226. ind. code § 31-34-1-10(1)(c) (2024). 227. kayla dwyer, where indiana’s candidates for governor stand on marijuana legalization, indystar (last updated jan. 8, 2024 2:33 pm), https://www.indystar.com/ story/news/politics/elections/2023/11/20/is-weed-legal-indiana-2024-governor-candidatespositions/71506905007/ [https://perma.cc/5nkw-7aah]. 228. id. https://perma.cc/5nkw-7aah https://www.indystar.com 2025] a recommendation for the indiana legislature 153 bill authorized by republican senator eric bassler and democrat senator rodney pol has been introduced to legalize medical marijuana in indiana upon the federal reclassification of marijuana off of the schedule i narcotics list. 229 in the dcs context, the department continues to substantiate on cases of marijuana positive infants. although the legislature enacted several recommendations by the cwg in their 2018 report on dcs, 230 the legislative response was to increase dcs’s budget to hire more family case managers rather than create policy instruments to reduce dcs involvement in low-risk families. 231 in the 2024 indiana legislative session, there were no bills introduced regarding dcs’s response to drug exposed infants and such reform is unlikely to occur in the near future. vi. conclusion the rates of prenatal marijuana use are increasing in the united states. 232 although the exact harms of marijuana exposure on infants are unclear, the government has a valid interest in promoting marijuana free pregnancies to ensure the health of mother and infant. however, the punitive approach taken by the indiana legislature creates more harm than good by adding stress to the family’s structure through dcs involvement, creating distrust between mother and physician via mandatory reporting laws, and burdening the court system and dcs employees with such cases. the indiana court of appeals has clearly held that evidence of marijuana in an infant cannot be the sole factor in supporting a chins adjudication. 233 since the indiana court of appeals will not adjudicate a child chins for in-utero exposure to marijuana, the goal of promoting marijuana free pregnancies is better obtained by removing dcs involvement in such cases to allow for healthcare workers to engage in honest conversations with pregnant women about the risks of use. amending indiana code § 31-341-10 to exclude marijuana furthers this goal and allows for medically informed prenatal care regarding marijuana use. as judge baker stated in his 2015 indiana court of appeals opinion, “dcs and the courts are overwhelmed with the growing number of chins cases statewide. all would be better served if the system focused its time, efforts, and ————————————————————————————— 229. s.b. 294, 123rd gen. assemb., second reg. sess. (ind. 2024). 230. the indiana legislature passed bills relating to support for foster care families, foster care children support, and an increased budget for dcs in response to the 2018 cwg report. see abraham hurt, holcomb touts improvements at indiana department of child services, s. bend trib. (june 16, 2019, 5:00 pm), https://www.southbendtribune.com/story/news/2019/06/ 16/holcomb-touts-improvements-at-indiana-department-of-child-services/117179292/ [https:// perma.cc/rn4v-a8gx]. 231. see id. (the dcs’s 2021 fiscal year budget was increased to more than 800 million dollars and a 25-million-dollar state surplus was redirected to the agency in 2018). 232. young-wolff et al., supra note 52, at 1745. 233. a.m. v. ind. dep’t of child. servs. (in re s.m.), 45 n.e.3d 1252, 1265–57 (ind. ct. app. 2015). https://www.southbendtribune.com/story/news/2019/06 indiana health law review [vol. 22:125 154 resources on the families who really need them. this [family of a marijuana positive infant] does not.”234 nearly nine years after judge baker’s opinion, it is time for the indiana legislature to statutorily ensure marijuana-exposed infants are best served through the healthcare system and end dcs’s involvement in their families. ————————————————————————————— 234. id. structure bookmarks indiana health law review eleanor kinney tribute barry r. furrow* eleanor kinney was a giant in health law scholarship, the master of medicare and medicaid, the critic of medical malpractice reforms, and the scholar of government action in health care. she was someone a fledging health law scholar would turn to understand why the world of health care regulation in the united states was shaped the way it was. i would see eleanor at health law conferences frequently in my long career in the field, particularly in the early years when the field was younger and smaller, and intimate conversations were easier to have. we shared an interest in health care quality—my focus early on was on hospitals rather than physicians, and hers was on the role of medicare in policing both cost and quality in hospitals, and the limits of tort reform in improving patient compensation for medical errors. i want in this brief essay to discuss two related themes that eleanor developed masterfully in her work on medicare: first, the evolution of the program from a benefits administration payment program to today’s p4p regulator; and second, her constant concerns about beneficiaries and the quality of care they receive under medicare, including fair treatment for adverse events. my own work has looked at the limits of tort as a compensation tool and more recently on the struggles of hospitals caught in a complex world of pay for performance (p4p) reimbursement metrics combined with artificial intelligence (ai) tools of detection of patient injury, and my own ideas have benefitted from her excellent scholarship. eleanor tackled the federal health programs, medicare and medicaid, early in her academic career.1 she was a master of medicare and its development—from a beneficiary payer, to a procurement agency, and finally to a regulatory powerhouse pursuing value-based purchasing. eleanor’s work on medicare’s evolution is thorough and well footnoted; i’m struck by her sheer skill in dissecting medicare’s evolution. it is fair to say that for most health law scholars, laboring in the vineyards of medicare was dry research indeed, lost in an everchanging and confusing regulatory morass of u.s. code provisions and payment reforms.2 eleanor’s background led her to focus on federal reimbursement programs. early in her career, she worked as a program analyst for the u.s. department of health and human services in washington, d.c. she later was assistant general counsel of the american hospital association. her early experience was bookended by her government work for health and human services and her work for the american hospital association—regulator and regulated, an ideal path to building an academic career based on a deep * barry furrow is the professor of law and director of the health law program, at the kline school of law at drexel university in philadelphia; he is the lead author of the health law casebook, health law: cases, materials and problems (8th ed. 2018). 1. see eleanor d. kinney, medicare payment to hospitals for a return on capital: the influence of federal budget policy on judicial decision-making, 11 j. contemp. l. 453 (1984). 2. see eleanor d. kinney, the accidental administrative law of the medicare program, 15 yale j. health pol’y, l. & ethics 111 (2015). 80 indiana health law review [vol. 17:79 understanding of the world of health care regulation. in her 2015 article “the accidental administrative law of the medicare program,” she lays out this evolution toward the modern medicare of accountable care organizations, with reimbursement tied to “shared savings” and to penalty structures of quality failures such as hospital readmissions, infection rates, and patient safety indicators.3 one could design a whole health policy course around this article as the framework for more detailed readings, cases, and examples. she describes this research area as follows: “[t]oday, the medicare program is governed by a complex web of legislative rules, interpretive rules and manuals, policy guidance and computer programs which guide a host of decisions on issues related to the operation of the medicare program.”4 from a young scholar’s perspective, this is a daunting starting point in understanding a system. fortunately, eleanor has done the work for us. she carefully outlined the building blocks with clear graphic depictions of structure.5 and she masterfully laid out how the current contours of medicare regulation were hardwired into medicare’s dna.6 her background made her one of the ideal health law academics to trace this evolution. she observed that unlike other federal benefit programs that provided health care services and items, medicare had to act as a purchaser of covered items and services from independent vendors rather than just distributing cash.7 in her words, “medicare eventually had to become a procurement program and finally a regulatory program. because of the inflationary costs and charges presented by providers and suppliers for compensation, the medicare program had to resort to rate regulation to control medicare expenditures.”8 i was a young lawyer at a law firm in boston during the early 1970s, as medicare blossomed into a major payer of hospital expenses. i represented, among my firm’s clients, massachusetts general hospital, and in that early era of medicare, i handled a medicare reimbursement hearing triggered by a government accounting office audit of the hospital. the appeals process was chaotic, administered by a fiscal intermediary, with no one really understanding the alleged overcharge. i was left to represent the hospital since no senior lawyer in my firm wanted anything to do with it. this was early in the awkward evolution of medicare as solely a payor of benefit costs, and it was already clear that medicare had to evolve beyond a mere payor to better police errors and what would eventually become massive medicare fraud. the need for medicare to change was obvious. eleanor was a student of medicare early in her career, as she cataloged its metamorphosis from benefits provider to benefits procurer to benefits policer to a benefit-cost mediator (and collaborator). this evolution of a benefits program to a financer of new delivery 3. id. 4. id. at 111. 5. id. at 113. 6. id. at 115. 7. id. 8. id. 2020] eleanor kinney tribute 81 models such as acos was driven by the vast sums of money that health care delivery required, the rapid growth of payments, and the need to protect the beneficiaries and more importantly the federal budget.9 eleanor writes: throughout this transformation, and with the mindset of a benefits program, medicare policy-makers wrestled with associated administrative law issues with a poor sense of how administrative law functions in a regulatory context. the result of their deliberations was the development of unanticipated and often unique procedures for making rules and policy, enforcing regulatory requirements and adjudicating disputes.10 medicare has adapted, as eleanor notes, developing a more collaborative approach to achieving regulatory goals, particularly with the growth of accountable care organizations.11 these acos, seeking the balance of higher quality care at a lower cost, are a big jump beyond crude cost containment tools that preceded acos. she correctly sings the praises of acos as offering a better model of delivery, involving patients, based on treatment evidence, and combining providers into a much more coordinated framework.12 this could well be a medicare success story in its evolution toward a collaborator with providers in promoting new models of care. let me introduce a critique of medicare as a regulator at this point. the other prong of medicare reimbursement may be the mr. hyde of medicare’s regulatory toolbox. medicare has become excited by the use of reimbursement to punish by penalizing hospitals. the use of pay-for-performance metrics are designed to focus on measurable specific conditions like hospital-acquired conditions (hacs), through the hac reduction program13, and through the use of patient outcome measures, such as patient safety indicators (psis) to score hospitals.14 fix the problem or take a medicare reimbursement hit, says cms to thousands of u.s. hospitals.15 cms brags that its non-payment policy for hacs, including mrsa and c. diff infections, has already saved medicare almost $350 9. see id. at 114, 117. 10. id. 11. id. at 139. 12. id. at 135. 13. hospital-acquired condition reduction program (hacrp), ctrs. for medicare & med ic aid se r v s . , h ttps:/ /www.cms.gov/medicare/medicare-fee-for-servicepayment/acuteinpatientpps/hac-reduction-program.html [https://perma.cc/82y8-3ac8]. 14. fact sheet on patient safety indicators, agency healthcare research & quality https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/systems/hospital/qitoolkit/combi ned/a1b_combo_psifactsheet.pdf [https://perma.cc/ry8m-4lbv]. 15. hospital-acquired condition reduction program fiscal year 2020 fact sheet, ctrs. for medicare & medicaid servs., https://www.cms.gov/medicare/medicare-fee-for-servicepayment/acuteinpatientpps/downloads/hac-reduction-program-fact-sheet .pdf [https://perma.cc/z75u-jxnr]. 82 indiana health law review [vol. 17:79 million each year.16 however, these figures represent money saved by medicare but money lost to hospitals,17 which they could have spent on other areas of patient care. here, medicare as the policer of adverse event costs has created tools that appear to be hardening medicare into a tougher and less flexible collaborator on patient quality metrics. eleanor would have read the new studies of the past two to three years and raised her voice to suggest that medicare needed to do much more work to sort out the validity of reimbursement measures used, or much staff time and hospital money would be wasted.18 these pay-for-performance penalty tools can be fixed, and hopefully will be, before billions in hospital income is misdirected.19 acos, on the other hand, hold out the promise of successfully striking the right balance but using a less intrusive regulatory approach to a new delivery structure of which physicians are willing to be part.20 my second theme in professor kinney’s scholarship is that of patient quality and the treatment of medicare adverse events. the previous discussion points to medicare’s emergence as the promoter of new models of health care organizations such as acos and new sharp-edged reimbursement penalty tools to reduce patient adverse events. it is clear that medicare is now obsessed not only with cost but also quality, although the quality metrics may not yet be sufficiently tested to be trusted.21 i’m more interested here in looking at eleanor’s prescient writing on a medicare system that would provide a compensation 16. hospital-acquired condition (hac) reduction program, ctrs. for medicare & medicaid servs., https://www.cms.gov/medicare/quality-initiatives-patient-assessmentinstruments/value-based-programs/hac/hospital-acquired-conditions [https://perma.cc/26zhux4g]. 17. see jessica martin, substantial economic burden attributed to recurrent clostridium difficile, infectious disease advisor (feb. 21, 2019), https://www. infectiousdiseaseadvisor.com/home/topics/gi-illness/clostridioides-difficile/substantialeconomic-burden-attributed-to-recurrent-clostridium-difficile/ [https://perma.cc/23smn37c] (explaining the money lost by hospitals for treatment of c. diff infections, i.e. the money lost by hospitals as a result of cms’ non-payment policy for hacs). 18. see elizabeth a. fehlberg, robert j. lucero, michael t. weaver, anna m. mcdaniel, a. michelle chandler, phyllis a. richey, lorraine c. mion, & ronald i. shorr, impact of the cms no-pay policy on hospital-acquired fall prevention related practice patterns, 1 innovation in aging art. igx036 at 1 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6002153/ pdf/igx036.pdf [https://perma.cc/jk84-srbk]. (“the cms no-pay policy increased utilization of fall prevention strategies despite little evidence that these measures prevent falls.”) 19. see generally aaron mendelson, karli kondo, cheryl damberg, allison low, makalapua motúapuaka, michele freeman, maya o’neil, rose relevo, & devan kansagara, the effects of pay-for-performance programs on health, health care use, and processes of care: a systematic review, 166 annals internal med. 341 (2017). 20. kinney, supra note 2, at 134-35, 138. 21. see niall brennan, allison oelschlaeger, christine cox, and marilyn tavenner, leveraging the big-data revolution: cms is expanding capabilities to spur health system transformation, 33 health affs. 1195, 1196 (2014). 2020] eleanor kinney tribute 83 scheme for patients who suffer adverse events. her article, with william sage, that i want to talk about is “dances with elephants: administrative resolution of medical injury claims by medicare beneficiaries.” this article offers a possible future for the new and improved medicare as a quality promoter through the use of medicare’s quality improvement organizations (“qios”).22 eleanor in this article notes the limits of qios as quality improvement tools. they exclude quality of care problems from mediation, thereby hiding provider errors from beneficiaries.23 qios also take few corrective actions against providers even with valid complaints.24 they fail to share information with other regulatory bodies.25 they are little more than tort-excluding, anti-compensatory creations of the early history of medicare.26 but they have great potential as a platform for a patient compensation process. eleanor jumps right to the recommendation of a “radical reinvention” of medicare’s complaint review process: “give qios both the authority and the responsibility not only to review complaints, but also to provide beneficiaries with complete information and appropriate compensation for medical injury.”27 she contends that giving medicare an injury compensation system for beneficiaries “could have a salutary effect on the malpractice system as well as on the weak system of complaint review that medicare currently supports.”28 qios haven’t yet evolved into a valuable federal compensation system, but medicare evolution in its use of system reform and reimbursement penalties perhaps has opened to door to eleanor’s elegant proposal. political pressure for a government-administered patient compensation system is currently lacking in the united states. a storm may however be brewing. first, hospitals are facing doctrinal movements in state courts to expand their exposure to liability, through corporate negligence doctrine.29 courts have become impatient with the halo defense that nonprofit hospitals used to be able to use.30 second, the level of adverse events in hospitals seems to be increasing,31 in spite of medicare efforts through cms reimbursement penalties, readmissions, and hospital-acquired conditions. third, the consumer movement in health care, as seen in patient 22. eleanor d. kinney & william m. sage, dances with elephants: administrative resolution of medical injury claims by medicare beneficiaries, 5 ind. health l. rev. 1 (2008). 23. id. at 5. 24. id. 25. id. 26. see id. at 4. 27. id. at 6. 28. id. 29. see larson v. wasemiller, 738 n.w.2d 300, 306-07 (minnesota, 2007) (adopting negligent credentialing for minnesota, the court noted that more than half of the state courts have adopted the tort. the concept also has support in restatement (second) tort sections such as sections 320 and 411). 30. see scott v. ssm healthcare st. louis, 70 s.w. 3d 560 (mo. app. ed. 2002). 31. david c. classen et al., ‘global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured, 30 health aff. 581, 581 (2011). 84 indiana health law review [vol. 17:79 engagement models and drives toward transparency in hospital billing,32 is sharpening citizen awareness of system failures in the u.s. health care system. fourth, the growth in the sheer size of baby boomers retiring into the medicare system provides fuel for disruptive changes.33 cms innovations in reimbursement through reimbursement and system reforms still leave patients “bare” when it comes to compensating them for infections, patient safety incidents, and other adverse events that have hurt them. for the elderly medicare patients, who have little access to the tort system anyway because of the problems in proving substantial damages, they are truly lost. eleanor wrote many articles on medical malpractice and tort reform. her work on qios suggests a masterful solution—a federal adverse event compensation model that schedules damage payouts, works efficiently through an administrative structure and thereby creates the financial pressures to force hospitals to pay attention at the highest level to adverse event generation.34 it is a perfect pairing for reimbursement penalties. i have learned a great deal from professor eleanor kinney over my career. she was a friend, a colleague, a sharp-edged critic of government policy, and an astute observer of medicare. she was one of the few scholars i would trust when i needed to fill in my own ignorance of medicare and its regulatory tools. and as i have reread, or read for the first time, her remarkable corpus of work, i see a remarkable mind at work—thorough, innovation, collaborative. she will be missed. 32. see julia james, health policy brief: patient engagement (2013), https://www.healthaffairs.org/do/10.1377/hpb20130214.898775/full/healthpolicybrief_86.pdf [https://perma.cc/tbd5-ruvz]. 33. see c2b solutions, understanding boomers, a disruptive force in american healthcare (2019), https://cdn2.hubspot.net/hubfs/300901/docs/understanding_boomers_a_ disruptive_force_in_american_healthcare.pdf?t=1455206530609 [https://perma.cc/n3ge-enlj]. 34. kinney & sage, supra note 22, at 6-7. an argument for multi-district climate litigation sidney m. lewellen* i. introduction climate change is no longer an abstract problem for future generations. it is an immediate threat to human life and health, the tangible effects of which can be seen and felt around the world. the news is teeming with examples of climate disasters. in march 2022, an antarctic ice shelf the size of rome collapsed due to abnormally high temperatures.1 in 2021, there were four major disasters that cost over $20 billion each.2 the average temperatures from 2010 to 2019 were the highest on record,3 and july 2021, was the hottest month in recorded history.4 nearly one third of the world’s population is exposed to deadly heat waves for more than twenty days out of the year.5 these are just a few examples of how climate change is already having a disastrous impact on the world. in its 2021 report, the united nations’ intergovernmental panel on climate change warned that many of the changes to our climate caused by carbon emissions will be irreversible for hundreds or thousands of years to come.6 the world health organization has dubbed climate change as the biggest threat to humanity, and climate change is projected to lead to an additional 250,000 deaths per year between 2030 and 2050.7 climate litigation is one strategy being used to address the impacts of climate change. while climate litigation has seen some success in other countries, climate * j.d. candidate, 2023, indiana university – robert h. mckinney school of law; b.s. 2019, ball state university. i would like to thank my advisors: professor daniel orenstein, for his thoughtful feedback, and scott a. faultless, for his thoughtful feedback and for fostering my interest in tort law. a special thanks to my husband, erin lewellen, and sister, cat vanmeter, for their unwavering support of all my endeavors. 1. donna lu, satellite data shows entire conger ice shelf has collapsed in antarctica, guardian (mar. 24, 2022), https://www.theguardian.com/world/2022/mar/25/satellite-data-showsentire-conger-ice-shelf-has-collapsed-in-antarctica [https://perma.cc/9bzc-dq8x]. 2. id. 3. facts about the climate emergency, un env’t programme, https://www.unep.org/ news-and-stories/speech/one-people-one-planet-peace [https://perma.cc/3sfp-87d4] (last visited mar. 21, 2022). 4. jeff masters, the top 10 global weather and climate change events of 2021, yale climate connections (jan. 11, 2022), https://yaleclimateconnections.org/2022/01/the-top-10global-weather-and-climate-change-events-of-2021/ [https://perma.cc/su96-yxnc]. 5. id. 6. richard p. allan et al., climate change 2021: the physical science basis, intergovernmental panel on climate change 1, 17 (2021), https://www.ipcc.ch/report/ ar6/wg1/downloads/report/ipcc_ar6_wgi_full_report.pdf. 7. climate change and health, world health org. (oct. 30, 2021), https://www.who. int/news-room/fact-sheets/detail/climate-change-and-health [https://perma.cc/uw6q-tvjp]. 412 indiana health law review [vol. 20:411 cases have struggled in the united states. u.s. climate litigation often faces procedural obstacles that have prevented climate cases from being resolved on the merits.8 a recent trend in climate litigation involves cities suing oil companies in state court, primarily using tort law.9 similar approaches led to success in the past with tobacco and opioid litigation, both of which resulted in large settlements. these city-led climate cases were having more success than previous climate litigation strategies in overcoming procedural hurdles. in four of these cases, the u.s. courts of appeals resolved jurisdictional issues in favor of keeping the cases in state court.10 this momentum was short lived because in may 2021, the supreme court gave a procedural win to oil companies in bp p.l.c. et al. v. mayor and city council of baltimore by leaving the door open for these city-led cases to be removed to federal court.11 procedural issues have already taken up three years in the baltimore case, and the supreme court’s refusal to decide the case on the merits shows it could take years before any of these city-led climate cases are resolved on the merits.12 while the future of climate litigation is unclear, there is hope that climate litigation can reach the same success as past social policy torts such as tobacco and opioid litigation. the success of climate litigation is vital because it would provide financial support to redress harms, raise awareness of the need for climate action, and mitigate or prevent future harm to the environment. this note will analyze the potential of these city-led climate cases, concluding that these cases have the best chance at making meaningful change through multi-district litigation in federal court. section ii provides relevant background on climate change’s impact on public health and the federal response to climate change in the legislative, executive, and judicial branches. section iii explores the recent city-led climate cases and the utility of using a state court approach to climate litigation. section iv compares climate, tobacco, firearm, and opioid litigation, and analyzes the strengths and weaknesses of climate litigation compared to these past social policy torts. section v analyzes the benefits of consolidating the city-led climate cases through multi-district litigation in federal court. section vi considers how on-going climate advocacy is necessary to ensure that money recovered from climate cases is allocated to climate-related purposes. 8. see discussion infra section iii. 9. norman w. spindel et al., circuit courts give climate change litigation new life in state court, lowenstein sandler (aug. 3, 2020), https://www.lowenstein.com/news-insights/ publications/client-alerts/circuit-courts-give-climate-change-litigation-new-life-in-state-courtenvironmental [https://perma.cc/s4va-jnhy]. 10. id. 11. ellen m. gilmer, supreme court’s climate case focuses on procedure, not policy, b.l. (oct. 5, 2020, 6:00 am), https://news.bloomberglaw.com/environment-and-energy/supreme-courtsclimate-case-focuses-on-procedure-not-policy [https://perma.cc/bw5j-4yq8]. 12. emma f. blake, kicking the climate can down the road: bp v. baltimore and chevron v. oakland, hausfeld (july 20, 2021), https://www.hausfeld.com/en-us/what-we-think/ perspectives-blogs/kicking-the-climate-can-down-the-road-bp-v-baltimore-and-chevron-voakland/#_edn5 [https://perma.cc/38vl-9qmk]. 2023] an argument for multi-district climate litigation 413 ii. background to understand the future of climate change litigation, it is important to understand why climate litigation is necessary in the first place. to do so, this section explores the impacts climate change has on public health, and the lack of a comprehensive federal approach to climate change policy in the united states. a. climate change’s impact on public health climate change and public health are inextricably linked. climate change impacts “many of the social and environmental determinants of health – clean air, safe drinking water, sufficient food and secure shelter.”13 climate change worsens the existing disease burden and further impedes healthcare access, which makes it harder to implement universal health coverage.14 it also exacerbates existing inequalities in healthcare.15 even though climate change has global consequences, it impacts communities differently.16 for example, a report by the environmental protection agency found that in the united states, climate change disproportionately affects underserved communities, and “racial and ethnic minority communities are particularly vulnerable to the greatest impacts of climate change.”17 the intergovernmental panel on climate change (“ipcc”) is the united nation’s body dedicated to climate change research.18 the ipcc was created in 1988, to provide governments “with scientific information that they can use to develop climate policies.”19 the 2021 report from the ipcc explains that human influence has caused the atmosphere, land, and air to warm, and it explains that without serious intervention the earth will warm by at least 1.5°c or 2°c before 2100.20 climate-related risks to health, livelihoods, food security, and water supply are projected to increase with global warming of 1.5°c and increase further with warming of 2°c.21 climate change affects the transmission of disease, increases the frequency of extreme weather events, and may cause food 13. climate change and health, supra note 7. 14. id. 15. id. 16. cdc policy, ctr. disease control & prevention, https://www.cdc.gov/climate andhealth/policy.htm [https://perma.cc/pwe6-zkvd] (last updated sept. 9, 2019). 17. press release, u.s. env’t prot. agency, epa report shows disproportionate impacts of climate change on socially vulnerable populations in the united states (sept. 2, 2021), https://www.epa.gov/newsreleases/epa-report-shows-disproportionate-impacts-climate-changesocially-vulnerable [https://perma.cc/852c-48nq]. 18. about the ipcc, intergovernmental panel on climate change, https://www. ipcc.ch/about/ [https://perma.cc/5vrl-8nty] (last visited oct. 15, 2021). 19. id. 20. allan et al., supra note 6, at 17. 21. id. 414 indiana health law review [vol. 20:411 shortages and malnutrition by disrupting patterns of food production.22 climate change already accounts for approximately 150,000 deaths annually.23 while people tend to view climate change as a national or international issue, there are tangible harms that can be seen in individual communities. an example of the local health impacts of climate change can be seen in baltimore, maryland. baltimore is a coastal city with sixty miles of waterfront land, which makes it particularly vulnerable to climate change.24 the sea level in baltimore rose thirteen inches between 1902 and 2006, and it rose at a rate higher than the global average.25 average temperatures in maryland have increased by 1.8°f, and intense precipitation events have increased by twenty percent in the last century.26 these figures are projected to worsen over the course of the next century. baltimore’s average annual temperatures are projected to increase by 12°f before 2100.27 heavy storm events will become more frequent, and baltimore’s sea levels are expected to rise another thirteen inches by 2050.28 these climate-change-related issues began to impact the health of baltimore residents, according to a study of maryland data from 2000-2012. during this time period, extreme heat events increased the risk of hospitalization for heart attack among baltimore residents by forty-three percent.29 exposure to extreme heat and precipitation significantly increased the risk of salmonella infections in maryland, and the risk was even stronger in coastal communities such as baltimore.30 exposure to extreme precipitation during the summer increased the risk of hospitalization for asthma by sixteen percent in baltimore.31 while these numbers are already alarming, it is projected that by 2040, increases in extreme weather will lead to another large increase of heart attack and asthma hospitalizations in baltimore.32 climate change already has tangible effect on the health of baltimore residents. the public health impacts of climate change, both locally and globally, are only going to become more palpable in the future. rather than trying to prevent 22. climate change, world health org., https://www.who.int/heli/risks/climate/climate change/en/ [https://perma.cc/ef2w-54jn] (last visited oct. 15, 2021). 23. id. 24. disaster preparedness and planning project: a combined all hazards mitigation and climate adaptation plan, balt. off. sustainability 1, 26 (oct. 2013), https://www. baltimoresustainability.org/wp-content/uploads/2015/12/chapter-1_introduction.pdf [https://perma.cc/46ky-mn5w]. 25. id. 26. id. 27. id. 28. id. 29. maryland climate and health profile report, md. dep’t health & mental hygiene 1, 19 (apr. 2016), https://mde.maryland.gov/programs/marylander/documents/mccc/ publications/reports/marylandclimateandhealthprofilereport.pdf [https://perma.cc/z483-hta5]. 30. id. 31. id. 32. id. 2023] an argument for multi-district climate litigation 415 or slow climate change, some countries have found it easier to simply adapt.33 many countries have tried to limit damage from climate change by spending massive amounts of money on adaptation measures.34 however, the reality is that climate change is beginning to outpace the human ability to adapt.35 this makes it more imperative than ever that individual countries, and the world as a whole, take substantial action to prevent further harm. without substantial action, the impact of climate change on human health will only worsen. b. climate policy in the united states the united states is one of the top four countries responsible for global carbon emissions, and in 2019, the united states was responsible for fifteen percent of the world’s total emissions.36 unfortunately, despite being one of the world’s biggest carbon emitters, the united states has not managed to make any meaningful federal plans to address the problem. congress has failed to enact any significant legislation to address climate change. starting in 1997, the senate unanimously adopted a resolution refusing to ratify the kyoto protocol, the first international treaty to cut greenhouse gases.37 in 2009, a sweeping climate bill was introduced into the house that sought to lower carbon emissions using a capand-trade system, whereby the government would give polluting companies a limited number of allowances to emit greenhouse gases and slowly reduce the number of allowances given over time.38 while the bill narrowly passed in the house, it did not reach a vote in the senate.39 this failure was followed by a decade of legislative inaction on climate change.40 the executive branch has tried to act, but changing administrations has led to revolving climate change regulation. because the legislature has been unable to pass climate legislation, temporary executive orders and regulations have been the main mechanisms to bypass partisan gridlock.41 but executive orders and 33. brad plumer & raymond zhong, climate change is harming the planet faster than we can adapt, u.n. warns, n.y. times (feb. 28, 2022), https://www.nytimes.com/2022/02/28/ climate/climate-change-ipcc-report.html [https://perma.cc/v4ca-asn7]. 34. id. 35. id. 36. max sarinsky, u.s. domestic climate policy – looking back, 11 eur. ass’n env’t & res. economists 1, 31 (2021), https://www.eaere.org/wp-content/uploads/2021/03/eaeremagazine-n.11-winter-2021.pdf [https://perma.cc/sl3j-m4mz]. 37. jeffrey pierre & scott neuman, how decades of disinformation about fossil fuels halted u.s. climate policy, nat’l pub. radio (oct. 27, 2021, 10:35 am), https://www.npr.org/ 2021/10/27/1047583610/once-again-the-u-s-has-failed-to-take-sweeping-climate-action-heres-why [https://perma.cc/h7d5-324f]. 38. id. 39. id. 40. sarinsky, supra note 36, at 31. 41. pierre & neuman, supra note 37. 416 indiana health law review [vol. 20:411 regulations have been swiftly overturned by subsequent administrations.42 for example, president trump rescinded countless regulations from the obama administration that were aimed at cutting carbon emissions.43 more recently, president trump pulled the united states out of the paris climate agreement, and president biden immediately rejoined it when he came into office. the ebb and flow of executive climate regulation does not provide a stable foundation to prevent further climate disruption. changing leadership is not the only issue that prevents climate action. even when legislative or executive action starts to gain traction, there is often political backlash from the public. while most scientists can agree that the earth has warmed since the industrial revolution, some scientists are skeptical that this warming is attributable to human influence.44 other scientists who do believe climate change is caused by humans still argue about which human activities are causing it.45 while most scientists believe greenhouse gases are to blame, some scientists have blamed “black soot, land use changes, and more.” it can be difficult for the legislative and executive branch to provide solutions to climate change when the cause of the problem is still disputed.46 there is further political debate regarding the economic implications of climate change that can prevent action. danish author bjørn lomborg argued that “efforts to reduce greenhouse gas emissions by eighty percent by 2050… would cost trillions of dollars and inflict more pain than climate change itself.”47 it is unsurprising that many governments, not just the u.s. government, are reluctant to take action to remedy climate damage and prevent future climate harm when such action would be very costly.48 these arguments about the underlying science behind climate change and the cost of acting only create more obstacles for the legislative and executive branch. because the united states lacks a comprehensive federal approach to climate change, states have had to fill in the gaps and create their own climate change policy. for example, twenty-five states have already committed to emission reduction goals in line with the standards set forth in the paris climate agreement.49 additionally, fifteen states and territories have “taken legislative or executive action to move toward a 100 percent clean energy future.”50 42. id. 43. id. 44. charles w. schmidt, a closer look at climate change skepticism, 118 env’t health persp. a536, a538 (2010). 45. id. at a538-a539. 46. id. at a539. 47. id. 48. id. 49. morgan higman et al., clean resilient states: the role of u.s. states in addressing climate action, ctr. for strategic & int’l stud. (feb. 9, 2021), https://www.csis.org/ analysis/clean-resilient-states-role-us-states-addressing-climate-action [https://perma.cc/z8f99jdf]. 50. sam ricketts et al., states are laying a road map for climate leadership, ctr. for am. 2023] an argument for multi-district climate litigation 417 this state leadership on climate change is not a recent development. in 1983, iowa was the first state to pass legislation encouraging and setting standards for the use of renewable energy, which prompted twenty-eight states and washington, d.c., to enact similar policies.51 california was the first state to adopt a comprehensive and economy-wide climate program in 2006.52 in fact, there were twelve states that sued the federal government in the landmark massachusetts case.53 states have shown far more willingness to address climate issues. while state climate leadership is a crucial step, the severity of climate change requires a federal and global collaboration to truly make the necessary changes. the lack of a substantial federal climate initiative and the growing health impacts of climate change have led people to turn to the courts for reprieve. c. history of climate litigation the united states supreme court first acknowledged climate change in massachusetts v. epa, admitting that “the harms associated with climate change are serious and well recognized.”54 in massachusetts, states, local governments, and private organizations filed suits against the epa.55 prior to the lawsuit, the epa had denied a rulemaking petition asking the agency to regulate vehicle emissions.56 as a result, the petitioners alleged that the epa “abdicated its responsibility under the clean air act to regulate the emissions of four greenhouse gases.”57 the supreme court reversed the epa’s decision to decline rulemaking, determining that the epa’s reasons for regulating vehicle emissions were arbitrary, and that its denial of the petition for rulemaking needed to be grounded in the clean air act.58 the supreme court’s decision did not require the epa to regulate vehicle emissions, but the epa did start regulating and studying vehicle emissions after the case.59 massachusetts “shows that the court can encourage agencies to regulate under already enacted statutes but does not ensure the court can provide its own relief to parties harmed by climate change.”60 progress (apr. 30, 2020), https://www.americanprogress.org/article/states-laying-road-mapclimate-leadership/#content [https://perma.cc/p4f9-5hsb]. 51. id. 52. id. 53. id. 54. massachusetts v. epa, 549 u.s. 497, 520 (2007). 55. id. 56. id. 57. id. 58. id. 59. elizabeth w. de leon, note, the opioid crisis or climate change: which is more likely to succeed under the tobacco litigation model?, 8 tex. a&m l. rev. 27, 59-60 (2021). 60. id. 418 indiana health law review [vol. 20:411 since massachusetts, climate litigation in the united states has been far less successful. many lawsuits seeking to hold government entities and corporations responsible for climate change have faced significant setbacks in federal courts due to issues with standing and preemption by the clean air act. for example, in american electric power company v. connecticut, three states and new york city brought public nuisance claims against electric companies under federal common law alleging that “the defendants' carbon-dioxide emissions created a ‘substantial and unreasonable interference with public rights.’61 the supreme court held that the clean air act preempts any federal common law right to relief for carbon emissions.62 similarly, in juliana v. united states, twenty-one young citizens tried to seek relief from climate change against the united state government.63 the plaintiffs claimed the government “violated their constitutional rights, including a claimed right under the due process clause of the fifth amendment to a ‘climate system capable of sustaining human life.’”64 the plaintiffs sought remedies such as, a declaration that the government was violating the constitution, and an injunction requiring the government to “cease permitting, authorizing, and subsidizing fossil fuel use… [and] to prepare a plan subject to judicial approval to draw down harmful emissions.”65 the ninth circuit determined that the claims were nonjusticiable.66 the court indicated that the requested remedies were unlikely to mitigate the plaintiffs’ injuries because the bulk of emissions come from nongovernmental sources.67 the court further determined that it is beyond the power of an article iii court “to order, design, supervise, or implement the plaintiffs’ requested remedial plan.”68 ultimately, the ninth circuit remanded the case to the district court with instructions to dismiss, explaining that the court is not the proper branch of government to enact climate policy.69 these cases illustrate that federal courts in the united states are often reluctant to get involved in climate litigation. while climate litigation has faced obstacles in the united states, there has been success in other countries. globally, climate cases have almost doubled in the last three years with at least 1,550 cases filed in thirty-eight countries during 2020.70 climate cases against governments have had success in other countries. in 2018, the supreme court of colombia ruled in future generations v. ministry 61. am. elec. power co., et al. v. connecticut, 564 u.s. 410, 418 (2011). 62. id. 63. see juliana et al. v. u.s., 947 f.3d 1159, 1164 (9th cir. 2020). 64. id. 65. id. at 1170. 66. id. at 1175. 67. see id. at 1170. 68. id. at 1171. 69. see id. at 1169-75. 70. climate litigation spikes, giving courts an ‘essential role’ in addressing climate crisis, united nations (jan. 26, 2021), https://news.un.org/en/story/2021/01/1083032 [https://perma. cc/3y3b-dtv3]. 2023] an argument for multi-district climate litigation 419 of the environment and others that “the constitutional rights to life, health, minimum subsistence, freedom, and human dignity were substantially linked to the environment and the ecosystem and ordered the government to develop and implement a plan to halt deforestation in the country.”71 similarly, in a landmark 2019 case against the government, state of the netherlands v. urgenda foundation, the supreme court of the netherlands determined the government was obligated “to take steps to reduce carbon emissions consistent with limiting warming to an average of 1.5°c.”72 finally, a dutch court gave a huge win to climate activists in milieudefensie et al. v. royal dutch shell by ruling that oil giant royal dutch shell “must reduce its greenhouse gas emissions to forty-five percent by 2030.”73 there are several factors that contribute to climate change litigation seeing less success in the united states than in other countries. one difference is that most countries in the world have guarantees to a clean environment within their constitutions, while the united states does not.74 this can make it more difficult for u.s. climate litigants to bring successful constitutional claims because the right to a healthy environment is not explicitly guaranteed. similarly, some countries with successful climate cases, like the netherlands, expressly allow interest groups to bring class actions.75 these kinds of laws can prevent the standing issues that u.s. climate litigants have faced in cases like juliana. additionally, countries that have a separation of powers doctrine like the u.s. have to overcome the additional hurdle of a judiciary that is unwilling to encroach on legislative or executive power.76 these differences between u.s. climate litigation and climate litigation in other countries has forced u.s. climate litigants to get creative in their strategies. iii. state tort law and climate change in response to obstacles in federal court, climate litigants begun suing large oil companies in state court. this new wave of litigation involves oil companies being sued by cities, including baltimore, that have experienced tangible harm caused by climate change. these cities are bringing their claims in state court using theories such as “nuisance, trespass, failure to warn, damage to property, 71. global climate litigation report: 2020 status review, united nations env’t programme 1, 15 (2020), https://wedocs.unep.org/bitstream/handle/20.500.11822/34818/gclr. pdf?sequence=1&isallowed=y [https://perma.cc/49vd-x2gu]. 72. id. 73. jeff brady, in a landmark case, a dutch court orders shell to cut its carbon emissions faster, nat’l pub. radio (may 26, 2021, 11:08 am), https://www.npr.org/ 2021/05/26/1000475878/in-landmark-case-dutch-court-orders-shell-to-cut-its-carbon-emissionsfaster [https://perma.cc/epx7-y7ne]. 74. global climate litigation report: 2020 status review, supra note 71, at 42. 75. id. at 39. 76. id. at 40. 420 indiana health law review [vol. 20:411 and various consumer protection and deceptive trade practices claims.”77 these climate suits are unique in that they focus on corporate wrongdoing as the basis for relief rather than bringing claims for emissions.78 the lawsuits are “underpinned by accusations that the industry severely aggravated the environmental crisis with a decades-long campaign of lies and deceit to suppress warnings from their own scientists about the impact of fossil fuels on the climate and dupe the american public.”79 information has come to light, showing exxon knew about the dangers of climate change caused by fossil fuels since the 1970s or 1980s, but paid over $31 million to block climate change solutions and spread misinformation to the public.80 exxon gave money “to members of congress who denied the expert climate consensus and acted to obstruct climate policies… [and] outside scientists who published some of the 2–3 percent of shoddy research that disputed the global warming consensus.”81 these city-led cases are unique because they emphasize local harm. past cases in the united states – like juliana and american electric power company – were focused on pollution as a violation of rights more generally. while courts have been unwilling to establish the right to a pollution-free environment, they appear more open to providing remedies for demonstrable harm caused by pollution. these city-led cases are brought by plaintiff cities like baltimore that can demonstrate actual harms such as sea level rise and increased climate related hospitalizations. by using a tort-based approach rather than a rights-based approach, these cases could allow courts to provide relief to climate litigants without causing too much political backlash. because these city-led cases are based on tort law, the cases do not necessarily require courts to deal with the more political and polarizing aspects of climate change. these cases can be decided narrowly on whether oil companies knew of the dangers associated with carbon emissions and if they failed to warn of them and engaged in deceptive trade practices. unlike massachusetts and juliana, state climate torts do not seek to force agency action or establish a right to a clean environment. because of this, state climate torts can be resolved in state court in a way that avoids making broad climate policy changes that would interfere with national and international approaches to climate change. 77. dylan bruce, climate change litigation plaintiffs have struck oil, b.l. (nov. 16, 2020, 4:39 am), https://news.bloomberglaw.com/bloomberg-law-analysis/analysis-climate-changelitigation-plaintiffs-have-struck-oil [https://perma.cc/3fnh-r67b]. 78. de leon, supra note 59, at 63-65. 79. chris mcgreal, big oil and gas kept a dirty secret for decades. now they may pay the price, guardian (june 30, 2021, 3:00 pm), https://www.theguardian.com/environment/ 2021/jun/30/climate-crimes-oil-and-gas-environment [https://perma.cc/3dae-kxgr]. 80. dana nuccitelli, two-faced exxon: the misinformation campaign against its own scientists, guardian (nov. 25, 2015, 6:00 pm), https://www.theguardian.com/environment/ climate-consensus-97-per-cent/2015/nov/25/two-faced-exxon-the-misinformation-campaignagainst-its-own-scientists [https://perma.cc/9uxb-8vyp]. 81. id. 2023] an argument for multi-district climate litigation 421 these cases have not been fully litigated on the merits yet, but they provide hope that state tort law may be able to provide relief to climate litigants in the united states. while state tort law may not be able to create comprehensive federal climate change policy, it has several potential benefits. it works to fill in the gaps left by a federal government that refuses to take necessary action to protect the public health from impending climate disaster. state tort law has historically served as an alternative to redress harm when federal law is inadequate.82 state-based climate cases have the potential to repay those who have been harmed by climate change; any money won through these cases could be used to mitigate the damage already done to local communities.83 additionally, holding oil companies and other major corporate polluters accountable and making them pay has the potential to deter them from further wrongdoing.84 state climate torts can also serve as a catalyst to foster the much needed legislative and executive action required to create a comprehensive federal climate plan.85 while these city-led cases are a unique new strategy with potential benefits for the climate, they still must overcome the same obstacles that have plagued past climate litigation to be successful. the common strategy for defendant oil companies in climates cases is removal to federal court. as discussed above, federal courts have shown a clear unwillingness to decide climate cases on the merits. this means that the federal court is more favorable to oil companies because it allows them to easily escape liability in climate cases. in the recent city-led climate cases, the defendant oil companies predictably attempted to remove to federal court, but the fourth, ninth, and tenth circuits all ruled in favor of litigating the cases in state court.86 one of these cases, mayor & city council of baltimore v. bp p.l.c., was recently heard by the u.s. supreme court. in baltimore, the defendants were removed to federal court invoking several statutes.87 the district court decided that none of the statutes authorized removal and remanded the case back to state court.88 typically, these remand orders are not appealable.89 however, 28 u.s.c. § 1447 states that an order remanding a case to state court is not reviewable on appeal unless the case was removed using the federal officer removal statute.90 because the defendants 82. karen c. sokol, seeking (some) climate justice in state tort law, 95 wash. l. rev. 1383, 1438 (2020). 83. id. 84. id. 85. id. 86. see city of oakland v. bp plc, 969 f.3d 895, 911 (9th cir. 2020); bd. of comm’rs of boulder cty. v. suncor energy (u.s.a.) inc., 965 f.3d 792, 827 (10th cir. 2020); cty. of san mateo v. chevron corp., 960 f.3d 586, 603 (9th cir. 2020); city council of baltimore v. bp p.l.c., 952 f.3d 452, 471 (4th cir. 2020). 87. bp p.l.c. v. city council of baltimore, 141 s. ct. 1532, 1536 (2021). 88. id. 89. id. 90. 28 u.s.c. § 1447. 422 indiana health law review [vol. 20:411 invoked the federal officer removal statute, § 1447 opened the door for appellate review in baltimore. however, the court of appeals for the fourth circuit interpreted 28 u.s.c. § 1447 as giving it limited authority to review only the part of the district court’s remand order that involved the federal officer removal statute.91 based on this, the fourth circuit affirmed the district court’s decision without reviewing the defendants’ other arguments for removal.92 the supreme court reviewed the case and determined that the fourth circuit’s interpretation of § 1447 was too narrow. the court held that § 1447 gave the appellate court not only the power to review the portion of the remand order involving the federal officer removal statute, but also the authority to review the entirety of the remand order including the defendants’ other removal arguments.93 the case was remanded back to the fourth circuit court of appeals for further consideration,94 opening the door for the fourth circuit to reverse the district court’s decision and allow the case to proceed in federal court. this narrow procedural ruling again illustrates the reluctance of federal courts, including the supreme court, to rule on the merits in climate cases. baltimore is a setback to climate litigation because it delays, or may prevent, the adjudication of climate cases on the merits. considering baltimore, several u.s. courts of appeals must reconsider whether to allow these city-led cases to remain in state court. in february 2022, the tenth circuit reviewed a case brought by multiple colorado cities against oil companies in light of the supreme court’s decision in baltimore.95 the tenth circuit determined for a second time that the case should be heard in state court.96 the tenth circuit is the first to rule on this jurisdictional issue since baltimore was decided.97 the baltimore case was also re-argued to the fourth circuit in january 2022.98 at the time this note was written, the decision in baltimore and several other city-led climate cases was still pending.99 while the recent win in colorado provides hope that state courts will be able to hear and decide these cases, there is still the chance that the cases will be removed to federal court. in federal court, different circuit courts of appeal 91. bp p.l.c., 141 s. ct. at 1537. 92. id. 93. id. 94. id. 95. sebastien malo, 10th circuit hands boulder's climate lawsuit the home court advantage, reuters (feb. 8, 2022, 6:44 pm), https://www.reuters.com/legal/litigation/10thc i r c u it -h an ds -bou lder s -c l im a te -law su it -h om e-cou r t -advan tage -2 0 2 2 -0 2 -0 8 / [https://perma.cc/g8nu-38br]. 96. id. 97. id. 98. kate fried, appeals court confirms that historic climate lawsuit will proceed in state court, boulder (feb. 8, 2022), https://bouldercolorado.gov/news/appeals-court-confirms-historicclimate-lawsuit-will-proceed-state-court [https://perma.cc/5rq8-6xyd]. 99. id. 2023] an argument for multi-district climate litigation 423 could reach different decisions on the issues, which could create a circuit split on the substantive issues like the procedural circuit split in baltimore. further, even if all these cases go back to state court, the oil companies will use their vast resources to delay the cases and make it a long time before substantive arguments will be heard. while these cases are waiting for a resolution and dealing with these delays in federal and state courts, climate change is only getting worse. people and communities are suffering, and the goal of climate litigation is to compensate for these harms and help deter future harm. because of this, it is necessary to look for alternative litigation strategies that could resolve climate litigation more efficiently. iv. comparing past social policy torts with climate litigation to analyze how these city-led climate torts can be resolved more efficiently, it is beneficial to compare them to past social policy torts. social policy torts allow litigants to use adjudication as the “first step to encourage new legislation, change public opinion, and uncover the truth about wrongful corporate conduct.”100 many social policy torts such as tobacco, firearm, opioid, and now climate litigation involve issues that impact public health. social policy torts are controversial, as some claim they threaten the democratic norms of society and bypass the legislative process.101 however, advocates of this strategy argue that social policy torts “are responding to a failure of government to meet its responsibilities to its citizens.”102 tobacco litigation is considered the first and most successful social policy tort.103 tobacco litigation began in the 1950s and had little success due to issues proving causation.104 by the 1990s, tobacco litigants began to use corporate wrongdoing as the nexus for their lawsuits as more information came to light showing that tobacco manufacturers “willfully ignored evidence of the harm caused by tobacco products.”105 by this time, there was more evidence proving the causal relationship between smoking and lung cancer, which helped eliminate public support for tobacco manufacturers.106 nearly every state attorney general brought suit against tobacco manufacturers, and a settlement was reached in 1998 where tobacco companies agreed “to fund anti-smoking programs and to curtail objectionable marketing practices.”107 firearm litigation has not had the same success as tobacco litigation. in the 100. de leon, supra note 59, at 28. 101. deborah r. hensler, the new social policy torts: litigation as a legislative strategy some preliminary thoughts on a new research project, 51 depaul l. rev. 493, 496 (2001). 102. id. 103. de leon, supra note 59, at 32. 104. 2 lawrence g. cetrulo, toxic torts litigation guide § 18:1 (2021). 105. id. 106. id. 107. id. 424 indiana health law review [vol. 20:411 late 1990s, individuals and cities tried to sue gun manufacturers for harm caused by third parties using state consumer protection laws and the public nuisance theory.108 but these attempts were unsuccessful and were either dismissed before trial or lost on the merits.109 unlike tobacco litigation, firearm litigation has “yet to yield a core body of repetitive, probative expert testimony that may be reliably used from one case to the next.”110 additionally, state attorney generals have not shown interest in pursuing firearm litigation, and there have not been enough cases to necessitate the kind of consolidation that makes a mass tort.111 a recent case brought by the relatives and survivors of the sandy hook elementary school shooting against the gun manufacturer remington has shown some potential. the plaintiffs claimed that the gun manufacturer violated connecticut consumer protection laws by wrongfully advertising guns for “for civilians to carry out military-style actions against perceived enemies.”112 the plaintiffs had a narrow win in 2019 when the connecticut supreme court allowed the litigation to proceed.113 after this win, remington offered to settle the lawsuit for around $33 million in 2021, and the sandy hook families ultimately settled with remington for $73 million in february of 2022.114 this case provides hope that similar consumer protection statutes in other states could be an avenue for relief for victims of gun violence.115 in contrast, opioid litigation has shown success following a similar strategy to tobacco litigation. opioid litigation used the public nuisance doctrine to sue pharmaceutical companies who manufactured and marketed opioids in state court. misleading marketing by pharmaceutical companies is remarkably similar to the marketing campaigns undertaken by tobacco companies prompting tobacco litigation. opioid litigants recently reached a $572 million settlement against johnson & johnson in oklahoma state court in 2019.116 the district court of oklahoma found that johnson & johnson’s false and misleading marketing about the risk of opioid addiction made it liable under state public nuisance law.117 three u.s. drug distributers and drug manufacturer johnson & johnson are 108. linda s. mullenix, outgunned no more?: reviving firearms industry mass tort litigation, 49 sw. l. rev. 390, 398-99 (2021). 109. id. 110. id. 111. id. 112. id. 113. id. 114. rick rojas et al., sandy hook families settle with gunmaker for $73 million over massacre, n.y. times (feb. 15, 2022), https://www.nytimes.com/2022/02/15/nyregion/sandyhook-families-settlement.html [https://perma.cc/s89y-w263]. 115. mullenix, supra note 108, at 398. 116. anthony juzaitis, analysis: the public nuisance doctrine is having a moment, bloomberg (nov. 4, 2019, 6:04 am), https://news.bloomberglaw.com/bloomberg-law-analysis/ analysis-the-public-nuisance-doctrine-is-having-a-moment [https://perma.cc/3gye-erah]. 117. judgment after non-jury trial at 12, oklahoma v. purdue pharma l.p., no. cj-2017816, 2019 wl 4019929 (okla. dist. ct. aug. 26, 2019). 2023] an argument for multi-district climate litigation 425 currently working out a twenty-six-billion-dollar settlement with forty-two states.118 a federal jury trial also recently found that pharmacies such as cvs, walgreens, and walmart, helped fuel the opioid epidemic in ohio under the same public nuisance theory.119 these recent opioid wins again demonstrate the power of mass social policy torts. a lot can be learned from these three examples. when comparing climate litigation to these examples, it has similarities to both the successful tobacco and opioid cases, and the less successful firearm litigation. one key factor distinguishing climate litigation and firearm litigation from opioid and tobacco litigation is political polarization. while tobacco and opioid use is more politically neutral, climate change and guns can be more divisive topics. most states and local governments took part in the tobacco and opioid settlements. on the other hand, few state attorney generals were willing to pursue firearm litigation. in this sense, climate litigation is more like firearm litigation because many states have expressed opposition to the city-led climate cases proceeding in state court. indiana and seventeen other states filed a brief with the supreme court in opposition to letting the cases continue in state court.120 similarly, indiana filed a brief along with twelve other states in the baltimore case, which argued that climate change is a global issue that states have no business deciding on.121 these briefs illustrate that states are not unified about climate litigation in the way that they were about tobacco and opioid litigation. climate change is a highly politicized and deeply partisan issue, with more democrats than republicans agreeing that “human activity is contributing a great deal to climate change (72% vs. 22%), that it is impacting their own local community (83% to 37%), and that the government is doing too little to reduce the effects of climate change (89% to 35%).”122 while nicotine and opioid 118. nate raymond, drug companies say enough u.s. states join $26 billion opioid settlement to proceed, reuters (sept. 7, 2021, 2:04 pm), https://www.reuters.com/world/us/drugcompanies-say-enough-us-states-join-26-bln-opioid-settlement-proceed-2021-09-04/ [https://perma.cc/vk5y-quxy]. 119. nate raymond, pharmacy chains including cvs helped fuel opioid epidemic, u.s. jury finds, reuters (nov. 23, 2021, 9:56 pm), https://www.reuters.com/legal/litigation/cvs-otherpharmacy-chains-found-liable-their-first-t r ial-over-us-opioid-epidemic-2021-11-23/ [https://perma.cc/5uet-aqbe]. 120. sarah bowman, indiana ag todd rokita files brief to stop california cities from setting climate policy, indy star (mar. 22, 2021, 7:40 am), https://www.indystar.com/story/ news/environment/2021/03/22/indiana-tries-stop-california-setting-climate-policy/4735937001/ [https://perma.cc/acv4-hu4s]. 121. brief of indiana, alabama, alaska, georgia, kansas, mississippi, missouri, nebraska, north dakota, south carolina, south dakota, texas, and utah as amici curiae in support of petitioners at 24, bp p.l.c. v. city council of baltimore, 141 s. ct. 1532 (2021) (no. 19-1189). 122. alec tyson & brian kennedy, two-thirds of americans think government should do more on climate, pew rsch. ctr. (june 23, 2020), https://www.pewresearch.org/science/2020/ 06 /23/two-th irds-of-americans-th in k-govern m en t -sh ou ld-do-m ore-on -climate/ 426 indiana health law review [vol. 20:411 addiction are typically viewed as individual or community problems, climate change is often viewed as a global issue. in fact, the number of americans who believe that their local area is impacted by climate change fell seven percent between 2020 and 2021 from twenty-four percent to seventeen percent.123 this perception of climate change as an international issue makes federal courts less willing to decide climate issues. any successful strategy for these city-led cases is going to have to overcome this obstacle. another characteristic that made the tobacco and opioid cases successful was their ability to prove harm. with opioid and tobacco litigation, there are specific people and communities who suffered severe harm and damages. however, proving firearm manufacturers are a cause of the harm is harder to prove in firearm litigation because there is the intervening actor that is the but-for cause of injury in cases of gun violence. because of this, firearm litigation is more about preventing future harms caused by gun violence. climate litigation falls in the middle of these examples. while climate change is already impacting human life, a substantial portion of the harm has not yet occurred. in this sense, climate change litigation is concerned with preventing or mitigating future harm like firearm litigation. future harms are more difficult to definitively prove than past or present harms. however, the city-led climate cases have the benefit of being grounded in real, evidence-based local harms. this reasoning shows that any new climate litigation strategy should maintain this city-based approach to show severe harm. additionally, tobacco and opioid litigation were successful because both were able to gather substantial evidence relating to corporate wrongdoing and misleading the public. similarly, in these city-led climate cases, there is proof of wrongdoing on the part of the defendant oil companies based on their knowledge of climate change and willful, continued use of deceptive marketing practices. as these climate cases continue and gather more information through discovery mechanisms, new evidence could also help garner more public support for climate litigation like in the tobacco litigation. finally, one of the most notable features of tobacco and opioid litigation that distinguishes them from firearm litigation is consolidation. both tobacco and opioid litigation were mass torts where plaintiffs joined instead of pursuing their claims individually. firearm litigation has been more focused on individual cases of gun violence, such as the sandy hook elementary school case. these city-led cases are currently being pursued by individual cities, but there is nothing preventing these cases from consolidating into a mass climate tort. a mass climate tort may be the solution to successfully and more efficiently resolving climate litigation in federal court. [https://perma.cc/l232-86va]. 123. alec tyson et al., local impact of climate change, environmental problems, pew rsch. ctr. (may 26, 2021), https://www.pewresearch.org/science/2021/05/26/local-impact-of-climatechange-environmental-problems/ [https://perma.cc/pr2a-qcv8]. 2023] an argument for multi-district climate litigation 427 v. the benefits of a federal climate mdl although federal court has not been welcoming to climate litigants in the past, these city-led climate cases could potentially succeed in federal court. first, there is federal district court precedent that these claims could avoid preemption by the clean air act. preemption has caused issue for climate cases in federal court, as seen in american electric. these city-led cases focus on the wrongful conduct of the oil companies rather than the emissions themselves. precedent from several federal district courts show that this argument may be able to survive preemption challenges.124 for example, the district court of new jersey determined that product liability claims against a diesel engine manufacturer were “not preempted because they were based on problems with the product, rather than violations of an emissions standard.”125 similarly, in the baltimore case, the district court actually disagreed with the defendants’ claims that baltimore’s state law claims were preempted by the clean air act, and the court declined to remove the case to federal court on preemption grounds.126 although this decision does not foreclose the possibility of the defendants’ using preemption as a state court defense,127 it shows that these city-led torts may stand a better chance of surviving preemption challenges that have defeated past climate cases. in addition to beating preemption obstacles, these city-led cases may also see success in federal court using the multidistrict litigation (“mdl”) model used in opioid litigation. mdls allow consolidated pre-trial proceedings for civil actions with usual questions of fact.128 mdls are a great tool to address complex litigation because they allow “one judge to consider pre-trial motions and discovery of multiple cases filed in different courts.”129 there are two procedures for creating an mdl. first, the judicial panel on multidistrict litigation (“jpml”) can initiate an mdl of its own accord.130 in the alternative, parties can file a motion in district court seeking the creation of an mdl.131 regardless of which procedure is used, at least four out of seven jpml members must agree to create an mdl.132 mdls differ from class actions because if the mdl cases are not settled or resolved, each case is sent back to its original court for trial.133 there would be 124. rachel rothschild, state nuisance law and the climate change challenge to federalism, 27 n.y.u. env’t l. j. 414, 449 (2019). 125. id. 126. city council of baltimore v. bp p.l.c., 388 f. supp. 3d 538, 563 (d. md. 2019). 127. id. 128. 28 u.s.c. § 1407. 129. de leon, supra note 59, at 48-49. 130. 28 u.s.c. § 1407. 131. id. 132. id. 133. rachel abrams, multidistrict litigation consolidation: pros and cons, plaintiff mag., at 1, 2 (jan. 2016), available at https://www.levinsimes.com/wp-content/uploads/2016/01/ 428 indiana health law review [vol. 20:411 several benefits to mdls in climate litigation. first, they often encourage settlement because the judge overseeing the mdl is “expected to work with the parties in finding a resolution.”134 in fact, “most mdl cases are resolved through aggregate settlements in the transferee courts or are finally resolved in other ways there without ever returning to the transferor court.”135 mdls also provide more consistent rulings by lessening the “risk of contrary legal opinions from different districts, even when the defendants and representative plaintiffs are dealing with the same underlying facts and apply the same legal analysis.”136 mdls help give plaintiffs leverage by allowing them to collaborate to show defendants the scope and seriousness of the claims against them, thus encouraging defendants to settle.137 finally, it can also be argued that the publicity surrounding the formation of an mdl is good for public health since it allows for public awareness of potential health hazards.138 there are three statutory requirements the cities in these climate cases would need to prove to create an mdl. first, civil actions must involve one or more common questions of fact.139 second, the consolidation of the cases must be for the convenience of the parties and the witnesses on balance.140 finally, the mdl must promote the just and efficient conduct of the cases.141 these factors often overlap, and the jpml does not tend to weigh each factor equally when deciding whether to form an mdl.142 the party motioning for consolidation has the burden of proving these elements.143 while these three factors are the only statutorily required conditions for creating an mdl, the jpml would have considerable discretion in determining whether to form a climate mdl and could consider other factors not explicitly mentioned in the statute.144 the first requirement of commonality is not usually sufficient on its own to create an mdl, but if a movant fails to prove this requirement, the jpml will usually deny the consolidation.145 the jpml has interpreted common questions abrams_multidistrict-litigation-consolidation_pros-and-cons_plaintiff-magazine.pdf [https://perma.cc/x2me-dh7n]. 134. de leon, supra note 59, at 49. 135. wen shen, cong. research. serv., lsb10365, overview of the opioid litigation and related settlements and settlement proposals 1, 2 (nov. 25, 2019), (available at https://crsreports.congress.gov/product/pdf/lsb/lsb10365 [https://perma.cc/5gak-vcvc]). 136. abrams, supra note 133, at 2. 137. see morgan a. mccollum, local government plaintiffs and the opioid multi-district litigation, 94 n.y.u. l. rev. 938, 966-67 (2019). 138. abrams, supra note 133, at 2. 139. 28 u.s.c. § 1407. 140. id. 141. id. 142. 15 charles alan wright & arthur r. miller, federal practice and procedure § 3863 (4th ed. 2021). 143. id. 144. id. 145. id. 2023] an argument for multi-district climate litigation 429 of fact broadly to include “important or dispositive questions of law, as well as factually similar cases involving the assertion of different legal theories.”146 this means it is not necessary for the parties and facts of the different cases to be identical to create an mdl.147 while an mdl can involve common questions of law, “if the common questions are purely legal, the statutory requirement for transfer literally is not satisfied.”148 city-led climate litigation meets this first mdl requirement. although each city has different questions of fact when proving the local impact of climate change on each city, they also share many common questions of fact. all cities must prove corporate wrongdoing by defendant oil companies and show that the companies knew about the environmental impact of their activities and actively spread misinformation to the public. there are also common questions of causation because cities must prove that the conduct of the defendant oil companies led to these local harms. also, since all these climate cases are based on the same public nuisance theory, there is a clear commonality when it comes to questions of law. these common questions of law and fact are likely to pass the jpml’s low bar for the commonality requirement. the second requirement for mdls, convenience for the parties and witnesses, carries the least weight.149 the jpml takes the position that the time and costs saved through consolidation will outweigh any inconvenience caused to some lawyers that have to travel to the mdl court.150 further, if the other two mdl requirements are met, the jpml will normally consolidate the cases because any “inconvenience can be mitigated by efficient management of the coordinated actions.”151 the second requirement is met in city-led climate cases because an mdl will be more convenient for both the plaintiffs and defendants. as of june 2021, there were twenty-six cases involving cities and states suing oil and gas companies using the public nuisance theory.152 for defendant oil companies such as shell, bp, exxon, and chevron, who are defendants in most of these cases,153 consolidating the cases will be more convenient because it will help avoid juggling various cases across several states during pretrial proceedings. additionally, both the plaintiffs and defendants are likely to have costly expert 146. yvette ostolaza & michelle hartmann, overview of multidistrict litigation rules at the state and federal level, 26 rev. litig. 47, 52 (2007). 147. id. 148. wright & miller, supra note 142. 149. ostolaza & hartmann, supra note 146, at 54. 150. wright & miller, supra note 142. 151. id. 152. chris mcgreal & alvin chang, how cities and states could finally hold fossil fuel companies accountable, guardian (june 30, 2021), https://www.theguardian.com/environment/ ng-in t e rac t ive /2 0 2 1 /jun /30 /climate-crimes-fossil-fuels-cit ies-states-in teract ive [https://perma.cc/2svx-58jt]. 153. see id. 430 indiana health law review [vol. 20:411 witnesses testifying on their behalf to prove or disprove causation, the nature and extent of the harms, and other elements. consolidation creates less of a burden on expert witnesses during the pretrial proceedings, and it would also save money by allowing plaintiffs to cost share when hiring expert witnesses. furthermore, mdls often lead to successful dispute resolution prior to trial. if the cases end up resolved in an mdl, both the plaintiffs and defendants would save significant amounts of time and money by avoiding the drawn-out litigation in multiple jurisdictions that is likely to continue if these cases proceed individually. all these considerations point towards the convenience of a climate mdl. the third factor for creating an mdl, which is that the mdl must promote the just and efficient conduct of the cases, is the most important factor.154 it is essential to show that consolidation will make the use of party and judicial resources more efficient to fulfill this requirement.155 if the movant can show “separate actions will lead to duplicative discovery (including expert discovery), the need for coordination becomes more persuasive and such a showing does not depend on total identity of the parties or claims.”156 however, the efficiency of an mdl is reduced if the individual cases have had significant rulings or are already nearing trial.157 yet again, city-led climate cases present a compelling case for creation of an mdl under this third and most crucial factor. because there are twenty-six cases alleging similar facts under the same legal theory that name the same few defendant oil companies, allowing the cases to proceed separately would clearly lead to duplicative discovery for the defendant oil companies to complete. additionally, combining these twenty-six cases is also going to conserve judicial resources by having the pretrial proceedings supervised in one court by one judge. having one judge in charge of pre-trial climate case proceedings would also increase consistency in outcomes across climate cases from varying districts. finally, due to procedural delays, there have not been any significant rulings on the merits of these cases, and they are unlikely to reach trial soon. because of this, it would be more efficient just to consolidate these cases into an mdl because they successfully meet all three of the statutory prerequisites. creating an mdl for city-led climate cases could help avoid many obstacles currently preventing the individual cases from progressing quickly enough. the mdl created for opioid litigation based on similar claims for corporate wrongdoing led to the pending twenty-six-billion-dollar opioid settlement previously discussed.158 if these cities could agree to litigate as an mdl and get approval from the jpml, climate litigation could see similar success. the jpml might be open to creating a climate mdl because it could help address the 154. ostolaza & hartmann, supra note 146, at 54. 155. id. 156. id. 157. id. 158. mdl 2804: national prescription opiate litigation, u.s. dist. ct. n. dist. ohio, https://www.ohnd.uscourts.gov/mdl-2804 [https://perma.cc/g248-ws8a] (last visited oct. 17, 2021). 2023] an argument for multi-district climate litigation 431 unique concerns presented by city-led climate cases. the consistency in rulings associated with mdls would help alleviate concerns by some states that these city climate suits would produce conflicting results and interfere with federal policy on climate change.159 having a consistent starting point through a climate mdl could make climate litigation easier to accept for people who view climate change as a national issue. additionally, since mdls encourage settlement, consolidating the cases could lead to a quicker resolution of the cases. through an mdl, the plaintiffs can combine resources, evidence, and bargaining power. this in turn could be the leverage needed to get the defendant oil companies to negotiate. for this reason, an mdl may be more beneficial than city-led climate cases proceeding in state court. even if the cases are successful in state court, it will take years for the cases to sort through procedural issues and be adjudicated on the merits. an mdl is more likely to reach a quick resolution like that of the opioid cases, which is critical because of the time sensitive nature of climate change. finally, the biggest benefit of a climate mdl is the publicity it would bring. a climate mdl could be the catalyst needed to push the federal government to enact a comprehensive climate plan. in fact, pushing the federal government to act may be the most important aspect of these cases. while monetary awards would allow these cities to counteract some of the damage climate change has caused, the money would not be a long-term solution to climate change. the publicity garnered from a climate mdl could help get the legislative and executive branches to finally take meaningful action on climate change. by putting public pressure on the legislative and executive branches, a climate mdl could help lead to the creation and enforcement of important climate regulations. this publicity is especially important considering the biden administration’s commitment to the environment and the potential for federal legislation. in an executive order from january 2021, president biden explains: it is, therefore, the policy of my administration to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; [and] to bolster resilience to the impacts of climate change.160 with a narrow democratic house majority for the first time in a decade, this could be the perfect time to push for more comprehensive federal environmental protections. this means that the publicity garnered from a climate mdl could 159. brief of indiana, alabama, alaska, georgia, kansas, mississippi, missouri, nebraska, north dakota, south carolina, south dakota, texas, and utah as amici curiae in support of petitioners at 24, bp p.l.c. v. city council of baltimore, 141 s. ct. 1532 (2021) (no. 19-1189); see also bowman, supra note 120. 160. exec. order no. 13990, 86 fed. reg. 7037 (jan. 20, 2021). 432 indiana health law review [vol. 20:411 make a stark difference in pushing the federal government to finally take much needed climate action. a climate mdl would not only put pressure on the federal government, but also on the oil companies. one of the main goals of social policy torts is to “reveal companies’ wrongdoings to the public so they are forced to change.”161 these city-led cases have already been making headlines, especially the baltimore case when it was heard by the supreme court. if these cities band together to create a climate mdl, this is likely to attract more public attention. as these cases progress through the court system, discovery is likely to produce more information regarding oil companies’ knowledge of the environmental impacts of carbon emissions as well as the deceptive practices the companies engaged in to hide this information from the public. this kind of publicity could help undo some of the damage created by oil companies’ decades long marketing campaigns that disseminated misinformation on climate change to the public. information demonstrating oil companies’ misdeeds could further affect stock prices for these companies, which could put added pressure on the companies to take steps to remediate the harm they have caused and mitigate any future harm. publicity is a valuable tool to help force oil companies to stop their harmful behavior. vi. the need for settlement safeguards while the success of past social policy torts provides hope that a climate mdl could reach a historic settlement, that is only half of the battle. a mass climate tort may succeed in court, but a climate tort’s ability to make meaningful change can be limited by how recovered money is used. an issue with social policy torts pursued by state and local governments is that the use of the funds will be determined by governors, attorney generals, and legislators.162 while most people assume that these settlement funds would have to be appropriated to climate related projects, this is not necessarily the case. the tobacco settlement provides a cautionary tale. the tobacco settlement did not legally require states to use their payments for smoking-related purposes, but many states pledged to do so anyway.163 for example, massachusetts passed legislation in 2000 allocating seventy-percent of settlement funds to a trust fund and thirty-percent to health care services.164 however, by 2003 the state was instead using the entirety of its tobacco payment 161. de leon, supra note 59, at 33. 162. principles for the use of funds from the opioid litigation, n.h. dep’t health & hum. serv., https://www.dhhs.nh.gov/dcbcs/bdas/documents/opioid-settlement-report.pdf [https://perma. cc/72qj-xahe] (last visited feb. 13, 2022). 163. vanessa o’connell, states siphon off bigger share of tobacco-settlement money, wall st. j. (oct. 9, 2003, 12:53 am), https://www.wsj.com/articles/sb106565273470749100 [https:// perma.cc/g2rc-3reu]. 164. id. 2023] an argument for multi-district climate litigation 433 for general budget purposes.165 states have repeatedly spent less than threepercent of their tobacco settlement money on tobacco prevention and cessation.166 rather than being earmarked to promote antismoking initiatives, states increasingly funneled tobacco money into general funds to help deal with budgetary gaps.167 tobacco settlements have essentially become a substitute for state revenue rather than a means to improve public health.168 with this in mind, public health scholars and coalitions are urging states to avoid repeating the same mistake with the recent opioid settlements.169 in october 2021, the office of national drug control policy announced the release of a model law for state legislatures to use to prevent opioid funds from being similarly appropriated.170 there is hope that this guidance from the white house will lead states to use the opioid settlement money for its intended purposes, but this is not a guarantee. this demonstrates that even if these climate cases are won in state or federal court, the fight is not over. ongoing climate advocacy will be necessary to ensure that these funds are used appropriately to mitigate climate change, counteract existing climate damage, ameliorate the climate burden on minority communities, and prevent future harm. vii. conclusion climate change is a pressing issue that is already having detrimental effects on the health of people all over the world. the lack of substantial climate action by the legislative and executive branches has led people to use litigation to combat climate change. climate litigants in the united states have had limited success due to procedural obstacles and preemption issues. city-led climate cases are the most recent strategy in the ongoing fight for successful climate litigation in the united states. while these cases could find success in state court, it may be more beneficial for them to proceed in federal court through multi-district litigation. a climate mdl provides several benefits that could make these city-led cases the next successful mass social policy tort. a climate mdl would allow the 165. id. 166. coalition publishes principles to guide state and local spending of opioid litigation settlement funds, johns hopkins u. (jan. 27, 2021), https://hub.jhu.edu/2021/01/27/principles-forspending-opioid-settlements/ [https://perma.cc/9p52-x837]. 167. o’connell, supra note 163. 168. see id. 169. coalition publishes principles to guide state and local spending of opioid litigation settlement funds, supra note 166. 170. press release, white house, ondcp announces model law for states to help ensure opioid litigation settlements funds address addiction and overdose (oct. 21, 2021), https://www.whitehouse.gov/ondcp/briefing-room/2021/10/21/ondcp-announces-model-law-forstates-to-help-ensure-opioid-litigation-settlements-funds-address-addiction-and-overdose/ [https://perma.cc/llg6-8nac]. 434 indiana health law review [vol. 20:411 dozens of cities that have initiated tort-based lawsuits against oil companies to combine their resources during pre-trial proceedings. this combined power has the potential to lead to a quicker resolution of climate cases and could help garner publicity surrounding the alleged misconduct of many large oil companies. this new wave of climate litigation may be enough to force oil companies to help repair the harm carbon emissions have done to the environment and mitigate future harm. however, ongoing climate advocacy is necessary alongside these climate litigation efforts to ensure meaningful change is realized. the relationship between food sovereignty and hawaiian health: the implications behind alexander and baldwin’s recent land sale kaylee kilolani michiko correa i. introduction the hawaiian creation story, or kumulipo, features wâkea (sky-father) and papa (earth-mother), parents of the hawaiian islands.1 ho#ohôkûlani was the daughter of wâkea and papa; wâkea and ho#ohôkûlani had a stillborn baby boy, so they buried him on the east side of their house, facing the sunrise.2 a plant soon grew in the burial spot, which became the first kalo (taro) plant, named hâloanakalaukapalili.3 wâkea and ho#ohôkûlani had another son, named hâloa, to honor his older brother, hâloanakalaukapalili; hâloa is said to be the first hawaiian and all hawaiians trace their mo#okûauhau (genealogy) back to hâloa.4 this story illustrates the familial-like connection hawaiians have with the land and the vitality of that connection: kânaka maoli [native hawaiians] trace their ancestry to the #âina (land), to the natural forces of the world, and to kalo (taro), the staple food of the hawaiian people. all are related in a deep and profound way that infuses hawaiian thought and is expressed in all facets of hawaiian life.5 native hawaiian6 land rights have been a highly debated issue for the past 125 years;7 yet, a neglected discussion is the impact of land rights on native hawaiian health. while obesity rates in hawai#i have decreased significantly in the past seven years, hawai#i still ranks 25 out of 50 for diabetes-related deaths, 17 out of 50 for physical inactivity, 29 out of 50 for low birthweight, and 38 out of 50 for excessive drinking, according to america’s health rankings.8 1. hâloa, kumukahi, http://www.kumukahi.org/units/ka_hikina/haloa [https://perma.cc/ npe9-zwbd]; cosmology, haw. his., http://www.hawaiihistory.org/index.cfm?fuseaction=ig. page&categoryid=276 [https://perma.cc/8fc5-svvc]. 2. hâloa, supra note 1. 3. id. 4. id. 5. melody kapilialoha mackenzie, historical background, in native hawaiian law: a treatise 1, 6 (melody kapilialoha mackenzie et al. eds., 2015). 6. for the sake of this note, “native hawaiians” and “hawaiians” are used interchangeably to denote all peoples of hawaiian ancestry. see haw. rev. stat. § 10-2 (2018). 7. see hawaii v. office of hawaiian affairs, 556 u.s. 163, 163 (2009) (holding that after the hawaiian monarchy was overthrown in 1893, hawai’i ceded all of its land to the u.s., including “public, government, and crown lands,” and that despite the 1993 congressional apology resolution, the state maintains the power to use or sell that land, as long as the “proceeds are held in trust for hawaiian citizens”). 8. united health found., hawaii summary 2017, america’s health rankings, https://www.americashealthrankings.org/explore/annual/measure/overall/state/hi?editionyear=2017 [https://perma.cc/y594-s9qr]. the low birth weight ranking is significant because one 258 indiana health law review [vol. 17:257 these poor health statistics are a result of, amongst other factors, a postcolonization reliance on imported and processed foods.9 so, reliance on food produced on hawai#i soil, particularly foods that fall within traditional hawaiian means of subsistence, seem to be a plausible solution to improving the health of our people.10 this concept is otherwise known as food sovereignty:11 a general definition of the concept is as follows:“[f]ood sovereignty . . . is that state of being in which ‘all community residents obtain a safe, culturally acceptable, nutritionally adequate diet through a sustainable food system that maximizes community self-reliance and social justice.’”12 however, it is difficult to pursue this endeavor when there is little land available; for instance, taro13 farmers in hawai#i face a handful of challenges, including a rapidly decreasing amount of agricultural land and a recent maui land sale demonstrates the importance of food sovereignty. the alexander & baldwin company (“a&b”) possessed over 41,000 acres of sugar cane land on maui and retained land and water rights to all of it; however, a&b stopped its sugar cane production in 2016 after 145 years of production.14 in 2018, a&b sold 41,000 acres of sugar cane land to a californiaowned company called mahi pono.15 initial reports suggest that mahi pono plans to grow a wide range of crops, such as coffee, fruits, and vegetables for local use and as exports.16 mahi pono also acquired kûlôlio ranch, a&b’s grass-fed cattle production project in partnership with maui cattle company, and central maui feedstocks.17 mahi pono’s two land purchases makes them the biggest private of the causes of low birth weight is mothers experiencing high blood pressure, diabetes, heart disease, or lung disease, all problems that can result from poor diets. 9. see claire k. hughes, traditional hawai#ian diet programs: a culturally competent chronic disease intervention, 5 pac. health dialog 328 (1998). 10. see kathryn true, reclaiming tradition: native hawaiian health systems emphasize healing ties to the land, in context: good med. 54 (1994). 11. alicia bell-sheeter, food sovereignty assessment tool 4 (2004). food sovereignty also includes the right (for all people) to generate “culturally appropriate” food and the right to self-sustaining food resources. 12. id. 13. jeremy miller, the (poi) power of hawaiian food sovereignty, sierra club (mar. 8, 2017), https://www.sierraclub.org/sierra/2017-2-march-april/feature/poi-power-hawaiian-foodsovereignty [https://perma.cc/ss7l-qqul]. taro was and is an integral part of the hawaiian diet; ancient hawaiians would eat up to ten pounds of poi (pounded taro mixed with water) per day. 14. lee imada, a&b map shows possible uses for fallow sugar fields, maui news (apr. 1, 2017), http://www.mauinews.com/news/local-news/2017/04/ab-map-shows-possible-uses-forfallow-sugar-fields/ [https://perma.cc/9c9m-24ye]. a&b sells 41,000 acres of former maui sugar lands, hawaii news now (dec. 20, 2018, 1:51pm), http://www.hawaiinewsnow.com/ 2018/12/20/ab-sells-acres-former-maui-sugar-lands/ [https://perma.cc/r6d8-xn34]. 15. a&b sells 41,000 acres of former maui sugar lands, supra, note 15. 16. id. 17. id. 2020] the relationship between food sovereignty and hawaiian health 259 landowner on maui.18 the people of hawai#i are quite familiar with private corporations coming in and purchasing land for commercial land development.19 haunani-kay trask, a prominent hawaiian activist, educator, and writer, noted that since 1893, hawaiian lands have been used for things like urbanization, resorts, and plantation agriculture.20 while most hawaiians are not supportive of the land development that occurred and continues to occur throughout the islands, they disagree on something that could impact hawaiian land rights: federal recognition.21 federal recognition is one of several hawaiian rights advocacy approaches circling around the native hawaiian community22 – indigenous peoples rights, decolonization, and sovereignty are the three other main theories.23 federal recognition grants tribes a government-to-government relationship with the united states in which they can self-govern and receive federal assistance.24 the indigenous peoples rights theory is rooted in international human law and focuses on protecting native hawaiian rights within the american legal structure.25 decolonization is also rooted in international law and strives to turn the state into an independent nation-state.26 lastly, sovereignty is based on the “states-rights frame of international law” and seeks to restore the hawaiian monarchy.27 a modified model of federal recognition is the logical and most immediate resolution to hawaiian health issues because it would be a major step towards hawaiian food sovereignty.28 in order to understand this, section ii explains the history of hawai#i, focusing on events leading up to and including the transformation in the land ownership and usage system from ad 600 until today. section ii will also provide an overview of native hawaiian health. section iii 18. id. 19. haunani-kay trask, the struggle for hawaiian sovereignty – introduction, cultural survival (mar. 2000), https://www.culturalsurvival.org/publications/cultural-survivalquarterly/struggle-hawaiian-sovereignty-introduction [https://perma.cc/w9qu-6w64]. 20. id. 21. anita hofschneider, the coming debate on federal recognition for native hawaiians, honolulu civ. beat (june 23, 2014), https://www.civilbeat.org/2014/06/the-coming-debate-onfederal-recognition-for-native-hawaiians/ [https://perma.cc/6pnq-mjqd]. 22. telephone interview with melody kapilialoha mackenzie, law professor, univ. of hawai#i at mânoa (jan. 25, 2019) [hereinafter interview]. 23. s. james anaya & robert a. williams, jr., study on the international law and policy relating to the situation of the native hawaiian people i, ii (2015), http:// legislature.maine.gov/doc/3139 [https://perma.cc/h43q-6jxv]. 24. frequently asked questions, u.s. dep’t interior: indian affs., https://www.bia.gov/ frequently-asked-questions [https://perma.cc/95ma-92c6]. 25. anaya & williams, supra note 24, at 3. 26. id. 27. id. at 19. 28. see bell-sheeter, supra note 11. 260 indiana health law review [vol. 17:257 will explore the concept of food sovereignty in general and how it can operate in hawai#i. section iv offers a case study of the multimillion-dollar sale of a&b sugar cane land on maui to a farming venture company, mahi pono. section v discusses the different legal theories hawaiian scholars have analyzed to reclaim hawaiian land rights. finally, section vi proposes a federal regulation as the most immediately attainable opportunity for hawaiians, specifically on maui, to progress towards food sovereignty. ii. the little-known narrative of “paradise” a. hawaiian history hawai#i attracts millions of tourists every year: in 2017, nearly 9.3 million visitors ventured to hawai#i.29 the tourism industry alone generates billions of dollars for our state.30 and though tourists visit the state to escape reality, it is important to remember the origin of “paradise” and the historical, spiritual link hawaiians share with their land. 1. hawaiian society pre-contact though the date of the original settlement of the hawaiian people is debated, the widely agreed upon timeframe is sometime in the 10th century, but no later than ad 1200.31 most evidence comes from early settlers on o#ahu, who were agriculturalists; from about ad 600-1100, the hawaiian social system was communal and organized around subsisting the #ohana where people had equal control over the land and natural resources.32 once the community grew on o#ahu, chiefs implemented many “public works” projects, which eventually spread to the rest of the islands; these projects produced a great amount of food while simultaneously supporting the remodeled hawaiian social system.33 despite this new social classification system, the kânaka maoli remained an agriculture and family-based economy34 ahupua`as (land divisions running from the ocean to the mountains) were the most common forms of land units used by the hawaiian people; commoners built irrigation systems, fishponds, hunted, harvested kalo, and fished.35 in other words, private 29. katie murar, hawaii tourism industry sets record for sixth consecutive year, pac. bus. news (jan. 31, 2018, 3:50 pm), https://www.bizjournals.com/pacific/news/2018/01/31/hawaiitourism-industry-sets-records-for-sixth.html [https://perma.cc/e8l5-9mcz]. 30. id. tourist spending produced $1.96 billion in state tax revenue. 31. mackenzie, supra note 5, at 6. 32. id. 33. id. at 7. on hawai#i island, projects included lo#i (irrigated taro terraces), water irrigation systems, and heiau (places of worship); on moloka#i and o#ahu, large fishponds were implemented. the “new” social classes were the ali#i (chiefs), kahuna (priests), and maka#âinana (commoners). 34. id. 35. id. at 9. “maka#âinana could freely trade and move within the ahupua#a . . . these activities were regulated by an intricate system of rules designed to conserve natural resources and 2020] the relationship between food sovereignty and hawaiian health 261 land ownership did not have a place in ancient hawai#i and was introduced when westerners arrived.36 thus, the hawaiians’ “mutual dependence” lifestyle worked well for centuries prior to the arrival of captain cook. 2. colonizers arrive – land use and ownership transforms captain james cook was an english navigator who “discovered” places such as tahiti, new zealand, and australia.37 he landed on o#ahu in 1778, where he was welcomed as a high chief or god.38 upon cook’s arrival, the estimated hawaiian population was between 400,000 to one million.39 the land ownership system was stable and spanned across all eight islands by this time.40 after kamehameha united all the islands, he delegated governance over lands to his chiefs in the traditional hawaiian manner and appointed other loyal ali#i (chiefs) as governors over each island.41 kamehameha i began to trade land with westerners in exchange for services, and soon, westerners wanted the right to grant land to their heirs.42 land rights between natives and foreigners immediately became an issue.43 for instance, the 1840 hawai#i constitution maintained the traditional land system, but created limitations, and was interpreted to prohibit the king from reclaiming land held by foreigners and allowing 50-year leases between governors and foreigners.44 westerners pressured the hawaiian government to secure their land, sometimes utilizing the influence of hawaiian government allies and foreign gunboats.45 several years later, the mâhele occurred, which was a process of multiple land divisions; the lands were split into government lands, the king’s lands, the ali#i and konohiki (headman of the ahupua#a) lands, and kuleana lands.46 provide for all ahupua#a residents.” 36. id. 37. cook, james (1728-1779), austrl. dictionary biography, http://adb.anu.edu.au/ biography/cook-james-1917 [https://perma.cc/5ax5-hk66]. “discovered” is in quotations to reference the doctrine of discovery, or the justification used by colonial powers to claim title to lands that were “newly discovered” by “invalidating or ignoring aboriginal possession;” this doctrine is still used in american indian law. what is the doctrine of discovery?, doctrine discovery, https://doctrineofdiscovery.org/what-is-the-doctrine-of-discovery/ [https://perma.cc/ jm8j-bkzs]. 38. captain cook arrives in hawai#i, hawaiihistory.org, http://www.hawaiihistory.org/ index.cfm?fuseaction=ig.page&pageid=265 [https://perma.cc/t335-zb5r]. 39. mackenzie, supra note 5, at 48. 40. see id. at 11. 41. id. at 10. 42. id. 43. see id. at 11. 44. id. at 11, 12. 45. id. 46. id. at 14. 262 indiana health law review [vol. 17:257 five years after the mâhele, the maka#âinana were to receive about one-third of the total land in hawai#i, but, they were only awarded about 1% via the kuleana act of 1850.47 at this point, land rights steadily began to slip out of hawaiian control and into western hands.48 essentially, westerners manipulated the hawaiian economy to benefit themselves by exploiting hawai#i sandalwood and introducing large-scale sugar plantations.49 many kuleana land grants were lost in this economic shift because natives were not taught this foreign legal system; additionally, the kuleana lands became wedged in between big agricultural or ranching ahupua#a that were now western-owned.50 moreover, the kuleana act contained a “really cultivated” clause that, upon court interpretation, prohibited farmers from claiming land; because hawaiians had always utilized the ahupua#a communally, there were only a small number of individual farmers.51 further, oni v. meek, 2 haw. 87 (1858) found that the kuleana act did not allow for the maka#âinana to grow crops or animals on unclaimed parts of an ahupua#a because the act only included land that the farmer cultivated and a lot for their home not exceeding a quarter acre.52 some believe westerners illegally seized land from hawaiians during this time, but it can be argued that the land transfers were a choice made by the kings and chiefs.53 in essence, they chose to accept the western land ownership system because they were not only pressured to do so, but because they wanted to ensure the survival of their people.54 nevertheless, the maka#âinana attempted to band together and hold these lands communally, but due to the fractioning of land interests, particularly sales to plantations, hawaiians lost even more land.55 similarly, chiefs lost control of their lands through debts owed to westerners.56 47. act of aug. 6, 1850, granting to the common people allodial titles for their own lands and house lots, and certain other privileges [hereinafter kuleana act], reprinted in penal code of the hawaiian islands 32-33 (1850), http://punawaiola.org/es6/index.html?path=/ collections/statutes/penalcode1850001.pdf [https://perma.cc/j5se-ydj8]. mackenzie, supra note 5, at 15. 48. neil m. levy, native hawaiian land rights, 63 cal. l. rev. 848, 857 (1975). 49. id. at 857. levy also notes that, due to the importation of foreign labor for asia and europe, hawaiians soon became “a minority in their own homeland.” 50. mackenzie, supra note 5, at 17. because native kuleana land farmers could not access former common cultivation and livestock areas, they were forced to leave their lands, which were either absorbed by surrounding landowners via adverse possession or simply not returned to them after being leased to westerners. 51. see id. at 15. other reasons why hawaiians could not secure kuleana land include: they could not afford it, they were unaware of or did not understand western land laws, they did not want to betray their chiefs by claiming land, and the population of hawaiians severely decreased due to widespread epidemics. 52. id. at 15-16. 53. interview, supra note 23. 54. see mackenzie, supra note 5, at 16-17. 55. id. 56. id. chiefs who tried to start large-scale agriculture were unable to meet the monetary 2020] the relationship between food sovereignty and hawaiian health 263 government lands were sold to native tenants in this post mâhele era to ensure that the kuleana act was upheld.57 but, by this time, westerners possessed about 320,000 acres of government lands.58 this land transition marked the beginning of the descent of the hawaiian kingdom and culture. 3. the overthrow and its results king david kalâkaua was forced to sign the 1887 constitution (“bayonet constitution”) due to the demands of “western business interests,” even though he intended to abolish voter property qualifications from the constitution of 1864.59 in 1893, queen lili#uokalani drafted and was set to authorize a new constitution, but the u.s. minister to hawai#i, john stevens, ordered american marines to honolulu to “protect american lives and property” on january 16, 1893.60 by this point, the rise of plantation-style agriculture meant most of the government lands were owned by non-hawaiians; many sugar plantations had long-term leases on government and crown lands.61 the provisional government took control of government lands and the crown lands and, when annexation with the united states failed, formed the republic of hawaii in 1894.62 the republic passed the 1895 land act, which merged the crown and government lands into public lands.63 in 1895, after royalist groups battled with the republic and martial law was declared, the royalist groups and lili#uokalani herself were arrested and she formally renounced the throne to the united demands of maintaining plantations and lost their land through foreclosure. 57. id. at 18. 58. id. 59. id. at 19-20. kalâkaua’s powers were reduced significantly – his military powers were subject to legislative control and his status became more symbolic than anything. see hawaii, laws of her majesty liliuokalani, queen of the hawaiian islands: passed by the legislative assembly at its session, 1892 343, 355 (1892), https://babel.hathitrust.org/ cgi/pt?id=mdp.35112204552212&view=1up&seq=9. 60. see mackenzie, supra note 5, at 20-21. american and european businessmen who controlled the hawaiian economy formed a “committee of safety” and proposed annexation to the u.s. by using the sugar industry as its primary motivation. annexationists then seized the government building, proclaimed that the monarchy was no more, and a provisional government was now in place. queen lili#uokalani realized that resisting could result in the unnecessary bloodshed of her people, so she ceded her power to the united states. 61. see id. at 18. the last census before the overthrow, taken in 1890, showed that hawaiians owned very little land, if any; though a small population, westerners owned over a million acres of land. 62. mackenzie, supra note 5, at 24-25. 63. id. at 24-25. “139 americans received 10,084 acres . . . in contrast, 230 hawaiians received 6,502 acres.” 264 indiana health law review [vol. 17:257 states.64 4. annexation, statehood, and beyond eventually, the united states annexed the republic of hawai#i and the republic ceded title to all public lands to the u.s.65 the estimated amount of land was about 1.8 million acres and valued around $5.5 million.66 the 1900 organic act stated that all ceded public lands would remain in control of the government and any sale or lease revenue coming from those lands would be deposited into the territory of hawai#i’s treasury to “benefit . . . inhabitants of the territory of hawai#i.”67 by 1921, the hawaiian homes commission act (“hhca”) was enacted, making over 200,000 acres of public land available to be leased for homesteading68 for native hawaiians with at least 50% of native hawaiian blood.69 and yet, the hhca still protected the interests of sugar plantation owners because “cultivated sugarcane lands,” under “homestead lease[s],” lands under right of purchase leases, and lands under “certificate[s] of occupation” were excluded from the act.70 in the 1959 hawai#i admissions act, the federal government turned over title to the majority of the “public lands” to the new state; additionally, the act required the state to adopt the hhca.71 approximately 373,719 acres of the public lands were set aside for federal government and military use.72 the lands 64. see id. at 25. in fear of her supporters’ deaths, the queen officially renounced all claims to the throne. 65. see id. at 27. 66. see id. at 27, 79. the ceded lands were hawaiian government and crown lands, originally reserved for hawaiians despite the transition to the “fee-simple ownership system” resulting from the mâhele. according to professor mackenzie, the joint resolution of annexation (enacted in 1898 by congress) “implicitly recognized the trust nature of the government and crown lands,” yet, much of the land was used by the federal government. thus, the “ceded” lands are often referred to as “public land trust” or “trust lands.” 67. id. at 28. the act was enacted, at least in part, to benefit of hawai#i inhabitants, however, the u.s. had legal title to the lands, thus, the federal government retained the right to use land. 68. homesteading, merriam-webster dictionary (2019). “homesteading” can be defined as: “the home and adjoining land occupied by a family” or “a tract of land acquired from u.s. public lands by filing a record and living on and cultivating the tract.” 69. mackenzie, supra note 5, at 30-31. hawaiian leaders originally asked for a bill that would allow hawaiians without any amount of “aboriginal blood” to be eligible for these homestead lands, but sugar plantation owners made it so that the blood quantum was set at 50% to protect their land interests. 70. id. at 31. 71. id. at 33. 72. see id. at 32. 227,972.62 acres of land were national parks. the federal government also had permits and licenses for another 117,413 acres of land and had acquired the fee interest of 28,235 acres. 2020] the relationship between food sovereignty and hawaiian health 265 that the new state received were to be held in trust for one of more of five trust purposes including “the betterment of the conditions of native hawaiians, as defined in the [hhca].”73 the 1978 hawai#i constitution stated that the office of hawaiian affairs (“oha”)74 would hold a part of the income and revenue from the lands granted to the state.75 additionally, section 7 of the hawai#i constitution affirmed land rights of all hawaiians, subject to state regulations.76 the hhca adoption section stated that these lands would benefit two groups: “the native hawaiians and hawaians”; all real or personal property was set aside for native hawaiians and hawaiians.77 the shifts hawai#i experienced between the arrival of captain cook in 1778 to statehood in 1959 impacted many things – culture, social structure, and the governmental system to name a few. one of the biggest and most lasting effects of this transformation has been its impact on native hawaiian health. b. hawaiian health though hawaiian health has significantly improved over the past sixty years, hawaiian health professionals remain concerned about challenges faced by the hawaiian population.78 to understand why, we must look back at the history of hawaiian health. ancient hawaiian history suggests that hawaiians were physically fit and strong from their labor and had low-fat, high-carbohydrate diets.79 the traditional hawaiian diet consisted of “a high amount of complex carbohydrates (78%), a moderate amount of protein (12%), and a small amount of fat (10%).”80 in a 1963 study, diabetes rates were six times higher in hawaiians living in hawai#i than caucasians living in hawai#i.81 full blooded hawaiians were found to have a diabetes prevalence rate of 48.8% while part hawaiians had 73. id. 74. melody kapilialoha mackenzie, native hawaiians and us law, in native hawaiian law: a treatise 273-74 (melody kapilialoha mackenzie et al. eds., 2015). haw. rev. stat. §10-6 (2018). oha was established by the hawai#i constitution in 1978 “to reaffirm the state’s obligation with regard to the public land trust, the former government and crown lands of the hawaiian kingdom.” oha has many powers, such as the power to obtain and oversee property and create public policies regarding hawaiian issues. further, oha is a state agency that is independent from all branches of government and self-governs with a board of trustees. 75. haw. const. art. xii, § 6. 76. haw. const. art. xii, § 7. 77. haw. const. art. xii, § 4. 78. email from joseph gonsalves, exec. dir., hui no ke ola pono, to author (sept. 21, 2018, 14:36 est) [hereinafter email] (on file with author). 79. jane h. lassetter, the integral role of food in native hawaiian migrants’ perceptions of health and well-being, 22 j. transcultural nursing, 63, 63-64 (2011). 80. id. at 64. 81. norman r. sloan, ethnic distribution of diabetes mellitus in hawai#i, 183 j. am. med. ass’n, 419, 419 (1963). 266 indiana health law review [vol. 17:257 a diabetes prevalence rate of 26.6%.82 by 1998, the poor health conditions of urbanized native populations in the pacific had been properly recorded, yet, there was little to no information about fruitful strategies to promote health within those populations.83 because “medically competent” healthcare professionals may not be aware of the correlation between lifestyle choices and recurring illnesses, they cannot treat native patients adequately.84 illnesses such as diabetes and hypertension were unusual in pacific islanders before westernization caused a shift in diet and a decrease in physical activity.85 in a 2008 study of hawaiians, filipinos, japanese, and caucasians living in hawai#i, hawaiian participants had the highest caloric intake out of all the ethnic groups as well as higher body mass indexes and higher waist-to-hip ratios than both japanese and caucasian participants.86 these health issues can be attributed to the impact of westernization on many ethnic (specifically, native) groups: the change away from traditional foods to high fat, high calorie, low fiber, refined foods, canned meats, imported food products and alcoholic beverages has resulted in significantly higher prevalence rates of obesity, cardiovascular disease, high blood cholesterol levels, glucose intolerance and the eventual occurrence of type ii diabetes mellitus within these ethnic populations.87 luckily, there are now organizations and programs in place to actively combat the negative health impact of westernization on native hawaiians, such as traditional hawaiian diet programs. traditional hawaiian diet (“thd”) programs began in 1987 and eventually became part of successful intervention programs that remedy the effects of illnesses, especially diabetes cardiovascular disease, and high blood pressure.88 thd programs normally last for three weeks and aim to teach obese and chronically ill participants about several things, including the culture and value surrounding traditional hawaiian foods, portion sizes, and cooking techniques.89 the first implemented thd program was the moloka#i diet study (“mds”) in 1987; the mds involved meals of traditional hawaiian foods, such as “fresh fish and occasionally chicken, taro[], sweet potatoes, yams, breadfruit, seaweed, bananas, taro leaves and sweet potato leaves, and several native greens.”90 the most well-known thd program is the wai#anae diet program (“wdp”), established in 1989; participants only consume pre-western contact hawaiian 82. id. at 419-24. 83. see generally hughes, supra note 9. 84. see id. at 329. 85. see id. at 330. 86. see lassetter, supra note 79, at 64-65. 87. hughes, supra note 9, at 328-29. 88. see id. at 330. 89. see id. at 329. 90. id. 2020] the relationship between food sovereignty and hawaiian health 267 foods, with the exception of a controlled amount of protein.91 the main sources of protein were fresh fish and sometimes chicken, similar to the mds.92 in its very first study, the wdp served ten men and ten women whose average body mass index was 39.6 (a body mass index of 30 or higher is considered obese), and the average weight loss was 7.8 kg (about 17 pounds).93 moreover, blood pressure levels and chronic asthmatic symptoms decreased amongst participants as a result of the first wdp.94 further, two of the six diabetic participants completely stopped taking their diabetes medication simply by sticking to the thd; subsequent wdp’s have yielded similar results to that of the first wdp.95 to even the non-academic or non-biased eye, the wdp demonstrates that consuming foods conducive to the thd is a beneficial way to lessen the effects of chronic illnesses such as obesity and diabetes. in 2001, the first three-phase uli#eo koa program incorporated thd and evaluated the wellness and physical health effects of the thd component.96 the uli#eo koa program offered similar information as the mds and wdp on what a thd consists of: the thd is composed of 78% carbohydrates, 12% protein, and 10% fat.97 pre-contact hawaiians had a predominately plant-based diet, consisting of “starchy and leafy green vegetables, a few fruits, moderate amounts of protein, and minimal fat.”98 examples of carbohydrate sources consumed by ancient hawaiians are taro and breadfruit; examples of leafy greens sources are taro leaves and seaweed; examples of fruit sources are bananas and mountain apples; examples of protein sources are fish and shellfish; and examples of fat sources are coconut and chicken.99 the uli#eo koa program report emphasized that taking preventative measures to preserve and benefit native hawaiian health is just as important as mediating the effects of illnesses such as obesity and diabetes.100 the report also concluded that the nutrients provided within this modified thd exceeded the national resource council dietary standards.101 the diets of koa (warriors) were that of the plant-based thd and these warriors had both strength and stamina.102 so, there is little reason to believe that the thd would not provide the same benefits for 91. see id. 92. see id. 93. see id. 94. see id. 95. id. 96. see generally jodi haunani leslie, uli#eo koa program: incorporating a traditional hawaiian dietary component, 8 pac. health dialog 401 (2001). 97. see id. at 402. 98. id. 99. see id. 100. see id. at 405. 101. see id. at 406. 102. see id. at 405. 268 indiana health law review [vol. 17:257 athletes, laborers, adults, and children of today. an interesting note made in the uli#eo koa program report is that, various traditionally hawaiian foods could not be served at every meal due to their “high cost and limited availability” [emphasis added].103 because of this, food substitutes had to be used; for example, instead of poi and fish, brown rice and lean chicken were served in daily meals.104 it is odd that foods with demonstrated health benefits over the course of at least 200 years are of “high cost and limited availability.” it appears that westernization did not only result in a loss of land, culture, and identity, it resulted in a loss of good health. thankfully, there are now a number of hawaiian organizations trying to incorporate or mimic thd programs into their projects. hui no ke ola pono, located on maui, is “one of five native hawaiian health care systems created under the native hawaiian health care act of 1988 and reauthorized under the native hawaiian health care improvement act of 1992.”105 joseph gonsalves, the executive director of hui no ke ola pono, remains concerned about the health of the indigenous people of hawaii: statewide and on maui, the native hawaiian population has been adversely affected by unmet needs and poor health indicators … by 2010, native hawaiians had the highest diabetes mortality rates either as an underlying cause of death (ucd) or contributing cause of death (ccd) (hawaii diabetes report 2010, hawaii department of health). eight primary diseases related to metabolic dysfunction include type 2 diabetes, hypertension, lipid problems, heart disease, non-alcoholic fatty liver disease, polysystic ovarian syndrome, cancer, and dementia. obesity is a marker for all of them, and these eight diseases account for a staggering 75 percent of the healthcare costs in the us.106 hui no ke ola pono received $3.1 million in federal funding for 2018, and as a result of this generous amount of money, they were able to create more services and programs for maui’s native hawaiian community.107 gonsalves provided an in-depth look at what exactly hui no ke ola pono does for the maui community: the hui’s nutrition program is unique with the “simply healthy café” providing nutritional outreach education and cooking demonstrations to all ages in the community[,] using the diet standards of the modified native hawaiian diet program (mea ‘ai pono)…the café also does special catering for cultural and community groups who have ask[ed] for their members to experience mea ‘ai pono for the first time. the physical exercise program (‘eleu) provides several avenues for exercise 103. id. at 403. 104. see id. 105. who we are, hui no ke ola pono, http://hnkop.org/about-us/who-we-are/ [https:// perma.cc/3l4e-w3gl]. 106. email, supra note 78 (emphasis added). 107. id. 2020] the relationship between food sovereignty and hawaiian health 269 such as walking, hulacise [“hula-exercise”], gym facility and swim aerobics . . . the mea ‘ai pono program also has an exercise component. health education and disease prevention presentations are offered to the community and client groups, along with community health screening and wellness events. a major delivery method for the hui is through health fairs. the hui, in partnership with other organizations will be collaborating in health fairs, participating with display, information[,] and enrollment booths. other programs that will be included: vital health screenings, including, eye, dental and medical screening exams, through a cadre of medical doctors, a dentists and allied health professionals.108 though hui no ke ola pono is a native hawaiian healthcare system, it services the entire maui community to improve the overall health and wellness of our island. and as mentioned earlier in this note, a necessary tool to improving the health of both hawaiians and the hawai‘i community as a whole is land. ma#o organic farms, a “community food systems initiative” on o#ahu, has stated: “[h]igh rates of food insecurity and diet-related health disparities have long impacted hawai‘i, while much prime agricultural land lays idle or slated for urban development.”109 in other words, access to agricultural land is key in improving hawaiian health, and improving indigenous health in this way is the goal of food sovereignty. iii. food sovereignty: the intersection of hawaiian land rights and health a. the concept of food sovereignty food sovereignty is where native hawaiian land rights and native hawaiian health intersect. dr. kyle powys whyte, a philosophy professor at michigan state university, noted: “[t]o understand this concept of food sovereignty, it is critical to be able to connect settler colonialism with the ecological value of food.”110 whyte cited to the detroit food justice task force and described food sovereignty as freeing up land to generate food for the community, which in turn, creates designs for “collective control of land and waterways.”111 further, food sovereignty “includes the true right to food and to produce food, which means that all people have the right to safe, nutritious and culturally appropriate food and to food-producing resources and the ability to sustain themselves and societies.”112 at the 1996 world summit, la via campesina defined food 108. id. 109. growing our farm to grow our youth, ma#o organic farms, https://perma.cc/93lmsu9x. 110. kyle powys whyte, indigenous food sovereignty, renewal and u.s. settler colonialism, in routledge handbook of food ethics 354, 354 (mary rawlinson & caleb. ward eds., 2016). 111. id. 112. bell-sheeter, supra note 11, at 4. 270 indiana health law review [vol. 17:257 sovereignty as “the right of each nation to maintain and develop their own capacity to produce foods that are crucial to national and community food security, respecting cultural diversity and diversity of production methods.”113 the concept of food sovereignty normally operates in the context of indigenous rights. for instance, federally recognized indian tribes ensured their rights to harvesting foods on treaty-enforced ceded lands by using “englishlanguage concepts and frames associated with concepts of inherent sovereignty, self-determination, cultural integrity, subsistence harvesting, and treaty rights as ways of justifying their own control over foods that matter culturally, economically, and nutritionally.”114 additionally, the first nations institute stated: control of native food systems is intricately connected to control of native assets, and increased native control of agricultural assets is an important strategy for increasing control of native food systems . . . because the federal government and the bureau of indian affairs (bia) hold this land in trust for native peoples, individuals and tribal governments often have little say in how their land is used or have little experience managing land for agricultural pursuits.115 essentially, native peoples hold quite a bit of land in trust but do not control how it is used, and thus are unable to use it for traditional agricultural purposes to promote physical, spiritual, and cultural health.116 a similar problem plagues native hawaiians, with the key difference being that hawaiians do not own a majority of their land and were unable to secure any sort of agricultural rights to the ceded lands.117 notably, most of the food available in native communities is supplied by either the federal government or non-native businesses, with a small number of prosperous, locally-supported agriculture endeavors.118 similar to that of native american communities, native hawaiians depend on traditional foods and connection with the land for strengthening physical, cultural, and spiritual health.119 in analyzing testimony from several native voices, dr. whyte observed 113. whyte, supra note 110, at 355. 114. id. at 356. casandia bellevue, gmos, international law and indigenous peoples, 30 pace int’l l. rev. 1, 33-34 (2017). moreover, a recent examination of food sovereignty in a native context noted: “[t]o be food sovereign is much more complex, but essentially it means food autonomy, and it is based on sustainable agricultural practices and an ability to shapes one's own means of subsistence. by preventing or in any way interfering with traditional seed saving or cultivation practices, companies are effectively depriving indigenous peoples of their food sovereignty” (emphasis added). 115. bell-sheeter, supra note 11, at 12. 116. id. see also johnson v. mcintosh, 21 u.s. 543, 562 (1823) (“the exclusive right of the british government to the lands occupied by the indians, has passed to that of the united states.”). 117. see miller, supra note 13. 118. see bell-sheeter, supra note 11, at 8. 119. id. at 9. 2020] the relationship between food sovereignty and hawaiian health 271 that indigenous people value food in a way that cannot be reduced to scientific nutritional quality measures.120 all the processes involved with food, from production to consumption, are “woven tightly with land tenure, a community’s way of life, reciprocal gift giving and life sustenance, connecting people in a community, and respect for nonhuman life.”121 dr. whyte went on to note the effects of settler colonialism122 on native communities, particularly on native food systems; settler colonialism interfered with the food systems’ ability to supply a community with things such as “cultural integrity, freedom, food security, public health.”123 therefore, food sovereignty is dr. whyte’s solution for native peoples to ensure their social, cultural, and physical health.124 for instance, the anishinaabe people’s food sovereignty with respect to wild rice is an intricate and robust relationship that allows the anishinaabe to adapt to modern life while simultaneously perpetuating their cultural identity.125 dr. whyte concluded that food sovereignty is a “strategic process whereby foods that are renewed serve to engender ranges of adaptive options that are appropriate when confronted with the challenges of indigenous erasure in settler landscapes.”126 likewise, for the hawaiian people, farming and consuming traditional foods is a claim to sovereignty and identity.127 b. hawaiian food sovereignty across the state of hawai#i, farmers are attempting to both restore hawaiian agriculture and “reorient the islands’ economy and food system, around local, traditional, organic produce.”128 danny bishop, a member of na hui kalo, a local organization dedicated to bringing back ancient farming methods, sees the efforts of hawaiian food sovereignty as a responsibility to the keiki (children).129 bishop reminisced on the success of hawaiian agriculture in ancient times, expressing that crops such as kalo, malay apples, bananas, and breadfruit were harvested for centuries and yielded enough to feed the entire population of hawai#i.130 but due 120. whyte, supra note 110, at 358. 121. id. 122. id. at 359-60. dr. whyte described settler colonialism as: “a structured process of erasing another population’s range of adaptation options” in which colonizers imposed their own “homelands and futurity” in indigenous lands. essentially, settlement is a method for colonizers to eliminate native peoples’ ways of life to make it their land culturally, socially, and politically so as to make the western way of life unavoidable. 123. id. at 359. 124. id. at 16. 125. id. at 361-63. 126. id. at 363. 127. miller, supra note 13. 128. id. 129. see id. 130. id. bishop also made note of the stark contrast between the shared responsibility model of hawaiian farming and the corporate pineapple and sugarcane farms that took over immense 272 indiana health law review [vol. 17:257 to the aftershocks of captain cook’s arrival, the traditional food system was eventually eradicated and our population cut in half; bishop believes hawaiian farming plays an integral role in the revitalization of hawaiian identity and health.131 however, this endeavor is not without hurdles: approximately 80% of crops grown in hawai#i are exported due to the modern-day “industrial monocrop” agriculture system.132 fortunately, the number of taro farmers continues to grow, in an attempt to “regain[] lost knowledge” through traditional agriculture.133 for example, ma#o organic farms is actively reclaiming hawaiian identity through farming.134 they commented on the islands’ significant food dependency and risk of food insecurity, stating that hawai#i imports 85% of its food and necessary elements to cultivate crops because “of global climate change, fuel price fluctuations and other economic disturbances.”135 daniel anthony, a well-known poi pounder, articulated a powerful statement on food sovereignty for hawaiians: “[e]ating is a powerful declaration of sovereignty. . . and the means by which native hawaiians will regain their independence.”136 as evidenced above, food sovereignty would enable hawaiians to improve our overall health, revitalize our identity, and regain our independence. yet, accessible agricultural lands in hawai#i are scarce due to the impact of the largescale sugarcane plantations.137 the a&b land empire illustrates this point. iv. alexander & baldwin case study a. the beginning of maui’s transition into large-scale agriculture in 1869, samuel thomas alexander and henry perrine baldwin, both sons of missionaries, purchased 12 acres of land in makawao on maui island for $110 to begin their sugar cane farming venture.138 in 1870, alexander and baldwin bought another 559 acres; six years later, the two men constructed an irrigation system that diverted water from haleakalâ (maui’s dormant volcano) to their sugar cane land in central maui.139 once alexander and baldwin passed away, the company continued to acquire more land and develop water systems, and “these resources, initially acquired for agricultural purposes, would eventually tracts of land on all the islands. “the chiefs had a reciprocal responsibility to the people and the environment . . . and the people had that same reciprocal responsibility to the environment and the chief.” 131. id. 132. miller, supra note 13. 133. id. 134. see growing our farm to grow our youth, supra note 109. 135. id. 136. miller, supra note 13. 137. see mackenzie, supra note 5, at 17. 138. history, alexander & baldwin, https://alexanderbaldwin.com/about/history/ [https://perma.cc/4d64-w8y7]. 139. id. 2020] the relationship between food sovereignty and hawaiian health 273 become the foundation of a&b’s strength and success today.”140 a&b is now one of the largest hawai#i real estate companies and has both commercial real estate and land development operations on maui, o#ahu, kaua#i, and the mainland.141 they “own, operate and manage 3.4 million square feet of retail, industrial, and office space in hawaii . . . . and [are] the largest owner of grocery and drug-anchored retail centers in the state.”142 in other words, it appears as though a&b has evolved past being a primarily agricultural company, so the 2016 maui sugarcane production shutdown brought speculation on what would be done with the land. pictured above: alexander & baldwin lands; credit: maui news b. a further departure from food sovereignty on maui after announcing its decision to stop producing sugar cane, a&b received backlash from farmers, locals, and activists as a result of the shutdown.143 in the 140. id. 141. see alexander & baldwin, inc. , alexander & baldwin 2017 annual report + form 10k 4-5 (2018), http://investors.alexanderbaldwin.com/static-files/2f648544-5459-46909134-d651c2ad4725 [ https://perma.cc/zs99-sag6]. 142. about, alexander & bald win , https://alexanderbaldwin.com/about/ [https://perma.cc/td6w-hw56]. 143. stephen mclaren, hawaii’s last sugar harvest paves the way for a fight over the land’s future, guardian (apr. 28, 2016), https://www.theguardian.com/usnews/2016/apr/28/maui-hawaii-sugar-cane-crops-agriculture-hcs-monsanto [https://perma.cc/s2jl274 indiana health law review [vol. 17:257 press release announcing the end of sugar cane production, a&b stated that it planned to divvy up the land into smaller farms for “varied agricultural uses.”144 specifically, a&b planned to use the land for things such as: “biogas feedstock crops,” “pongamia orchards,” and beverage crops.145 the most fascinating part of a&b’s plan was an agricultural park component: a&b plans to establish an agriculture park on former sugar lands in order to provide opportunities for farmers to access these agricultural lands and support the cultivation of food crops on maui. hc&s employees will be given preference to lease lots from the company to start their own farming operations.146 pictured above: 2017 proposed agricultural plan; credit: alexander & baldwin, inc. this press release seemingly gives hope to the possibility of achieving food sovereignty – maui farmers who grow traditional hawaiian crops would have access to land that has been out of their grasp for years. since 2016, a&b has entered into discussions with “hundreds” of interested parties, most of whom intended to grow one crop on only parts of the plantation jvmp]. 144. press release, alexander & baldwin, alexander & baldwin announces transition of hawaiian commercial & sugar company to a diversified farm model (jan. 6, 2016), http://investors.alexanderbaldwin.com/news-releases/news-release-details/alexander-baldwinannounces-transition-hawaiian-commercial-sugar [https://perma.cc/nv9y-953d] [hereinafter transition]. 145. see imada, supra note 15. 146. transition, supra note 144. 2020] the relationship between food sovereignty and hawaiian health 275 land.147 the company eventually found mahi pono, a startup farming venture company resulting from the efforts of a california-based agricultural group, pomona farming, llc, and a canadian pension investment manager, public sector pensions board.148 according to pomona farming’s website, “maui pono is a maui farming company dedicated to transforming 41,000 acres of vacant former sugarcane land and 15,000 acres of watershed into a thriving hub of diversified agriculture, community engagement, and local employment.”149 mahi pono is based out of wailuku, maui and consists of a&b’s former diversified agriculture employees, east maui irrigation employees, and a handful of experienced farmers.150 mahi pono also intends to utilize the land to “operate the property as a large diversified agriculture farm” and is considering including crops that are part of the traditional hawaiian diet.151 the first phase of mahi pono’s plan is to open a community agriculture farm, one of a&b’s original goals after stopping sugar cane production.152 this community farm would provide one, five, and ten-acre tracts of land to maui farmers, who currently have crops but are in need of land and water for crop rotation; the farmers would also have access to mahi pono’s “equipment, management, budgeting and marketing services.” 153 additionally, the community farm would reserve plots for research, offer collegiate and high school internships, and have an advisory board made up of locals who would determine the rules for the farm.154 as of february 2019, mahi pono planned on implementing their first round of agricultural endeavors by planting “leafy green vegetable crops” within six to eight months.155 mahi pono’s plans create both hope and skepticism within the maui community; particularly, maui residents are concerned about transparency for what exactly will be grown and the disproportionately high costs of farming on 147. press release, alexander & baldwin, a&b agreement with mahi pono launches new era of agriculture on maui (dec. 20, 2018), http://investors.alexanderbaldwin.com/news-releases/newsre leas e -de t a i ls / ab-agreem en t -m ah i-pon o-lau n ch es -n ew -era -agr icu ltu re-m au i [https://perma.cc/kyk8-b5wx] [hereinafter press release]. 148. mahi pono purchase of former hc&s lands helps ensure agricultural future for maui, businesswire (dec. 20, 2018, 5:01 pm), https://www.businesswire.com/news/home/2018 1220005936/en/mahi-pono-purchase-hcs-lands-helps-ensure [https://perma.cc/kz94-6fdu]. 149. projects, pomona farming, https://pomonafarmingllc.com/projects/ [https://perma. cc/qg7s-ry2u]. 150. email from grant nakama, operations manager, mahi pono, to author (feb. 1, 2019, 19:28 est) (on file with author). 151. id. 152. colleen uechi, community farm near mill in mahi pono early plans, maui news (feb. 1, 2019), http://www.mauinews.com/news/local-news/2019/02/community-farm-near-mill-in-mahipono-early-plans/ [https://perma.cc/57s6-pezr]. 153. id. 154. see id. 155. see id. (emphasis omitted). 276 indiana health law review [vol. 17:257 maui.156 brandon sato, president of kula onions etc., llc and a long-time maui farmer, observed that maui county is the state’s highest food importer because the costs of doing business for local farmers is quite high.157 however, sato asserts that there is a niche for traditional hawaiian crops (e.g. taro, taro leaves, and breadfruit) on maui, but the biggest obstacle farmers face is obtaining land to compete with larger farms within the state and on the mainland.158 while mahi pono’s 41,000+ acre purchase came as a surprise to the maui community, 2018 also saw a shocking end to the 17-year battle over water rights between a&b and native hawaiian farmers – the state commission on water resource management ordered the full restoration of ten of maui’s streams for kalo farming and limited diversion of seven more streams for habitat restoration.159 moreover, in an august 2018 article published by pacific business news, a&b agreed to sell over 300 acres of its agricultural land to the state of hawai#i to expand the kahului-maui airport.160 since shutting down its sugar cane production, a&b has sold approximately 46,000 acres of land to mahi pono and reported profits of about $270 million.161 it is also important to recognize how a&b was able to acquire its land in 1869 to better understand why the mahi pono land purchase is important. in other words, the events that allowed a&b to make its original land purchase are critical to this argument. according to james podgers, former editor of the aba journal, before hawaiian citizens voted for statehood in 1959, america took hawai#i off the united nations’ list of non-self-governing territories.162 the vote instead asked residents if hawai#i should be admitted as a state.163 in 1996, professor richard falk of the center of international studies at princeton university wrote to sovereignty groups in hawai#i, stating that: “‘[i]t can…be concluded as a matter of law’ that native hawaiians ‘never relinquished, in any appropriate or binding form, their right to self-determination under international law.’”164 many scholars and activists use international law to argue for hawaiian rights, and there are three core theories based on international law pursued by these hawaiian 156. see id. 157. telephone interview with brandon sato, president, kula onions etc., llc (jan. 26, 2019). 158. id. 159. lee imada, taro growers, practitioners elated with e. maui water rights decision, maui news (june 21, 2018), http://www.mauinews.com/news/local-news/2018/06/taro-growerspractitioners-elated-with-e-maui-water-rights-decision/ [https://perma.cc/j48j-crv9]. 160. janis l. magin, a&b selling land for airport expansion, maui shopping center in separate deals, pac. bus. news (aug. 2, 2018, 9:02pm), https://www.bizjournals.com/pacific/ news/2018/08/02/a-b-selling-land-for-airport-expansion-maui.html?ana=yahoo&yptr=yahoo [perma.cc/wup2-d5hq]. 161. press release, supra note 147. 162. james podgers, greetings from ‘independent’ hawaii, 83 a.b.a. j. 74, 76 (1997). 163. see id. 164. id. 2020] the relationship between food sovereignty and hawaiian health 277 groups.165 thus, a concise analysis of hawaiian case history and each advocacy theory will offer a clearer foundation for the relationship between hawaiian health and food sovereignty. v. potential legal strategies to accomplish hawaiian food sovereignty without land, hawaiians have no chance at food sovereignty. without food sovereignty, hawaiian health suffers from decreased availability of foods conducive to the thd. fortunately, land can be reclaimed through sovereignty, federal recognition, and other rights-based theories. each of these, as well as the cases leading up to their creation, is outlined below. a. an abbreviated case history in price v. state of hawaii, 764 f.2d 623 (9th cir. 1985), a group called hou hawaiians sued the state under 28 u.s.c. §1362166 for “failing to expend any . . . funds ‘for the betterment of the conditions of native hawaiians.’”167 the 9th circuit found that hou hawaiians did not qualify for jurisdiction under this section of the code because they were not federally recognized by the secretary of the interior and dismissed the case.168 later, in rice v. cayetano, 528 u.s. 495 (2000), a non-hawaiian citizen of hawai#i attempted to vote in the oha election but was denied eligibility and brought suit.169 the supreme court found that the hawaiian ancestry limitation violated rice’s right to vote because it was racially exclusive.170 further, native hawaiians are not considered a “political group” like federally recognized tribes, so a racially exclusive vote is unconstitutional.171 finally, in kahawaiolaa v. norton, 386 f.3d 1271 (9th cir. 2004), plaintiffs sued the department of interior for precluding native hawaiians from the tribal acknowledgment process.172 the court concluded that the department of interior failed to adequately determine native hawaiians’ eligibility for a government-togovernment relationship, but nevertheless left the question of eligibility for 165. anaya & williams, supra note 24, at 3. 166. 28 u.s.c. § 1362 (2018) (giving federal district courts jurisdiction over lawsuits filed under federal law brought by federally recognized native american tribes) (this section has not been amended since 1985, the year of the case being discussed). 167. price v. state of hawaii, 764 f.2d 623, 625 (9th cir. 1985). 168. see id. at 626. 169. rice v. cayetano, 528 u.s. 495, 499 (2000) (stating that oha’s election process involves choosing nine members of hawaiian ancestry to a board of trustees on four-year terms; at least one member each must be from kaua#i, o#ahu, moloka#i, maui, and hawaii island) and a chairman and vice-chairman are elected by the board). mackenzie, supra note 74, at 273-74. 170. rice, 528 u.s. at 522. 171. id. 172. kahawaiolaa v. norton, 386 f.3d 1271, 1272 (9th cir. 2004). 278 indiana health law review [vol. 17:257 congress.173 because hawai#i has a unique history with the united states (when compared with native americans), congress has created native hawaiian federal programs and benefits that differ from federally recognized tribes.174 b. three hawaiian advocacy theories the commonality between the above cases is simple: the lack of federal recognition has precluded hawaiians from asserting their rights for years. yet, there are hawaiians who seek to obtain recognition of our rights under international law.175 james anaya, dean of the university of colorado-boulder law school and robert williams, jr., professor at the university of arizona college of law, declared the following: the duty of states (that, is independent states, in particular those that are members of the united nations) to recognize indigenous peoples and to respect and protect their rights is well established under international law and policy. the united states has the responsibility to recognize and protect these rights and to provide remedies for their infringement. this responsibility applies toward native hawaiians, who unquestionably qualify as an indigenous people within the contemporary international understanding of the indigenous rubric.176 rooted in this duty, anaya and williams outline three main schools of thought in the pursuit for hawaiian rights: indigenous peoples’ rights, decolonization, and sovereignty.177 1. indigenous peoples’ rights theory per this view, the target is native hawaiians, and the united nations declaration on the rights of indigenous peoples178 and international human rights 173. id. at 1280, 1282. 174. id. at 1282. programs include the hawaiian homes commission act and the native hawaiian health care improvement act. 175. see anaya & williams, supra note 24, at ii. 176. id. at i. 177. see id. at ii. 178. id. at i, 4-5. the united nations declaration on the rights of indigenous peoples (“declaration”) was adopted by the united nations general assembly in 2007. the united states, along with other independent states, voted against the declaration, but it was later endorsed in 2010 by president obama. the declaration is not legally binding, but is legally important because: [it] represents an authoritative synthesis of the human rights principles found in various treaties, beginning with the united nations charter, and their application to indigenous peoples . . . the declaration can be seen as expressive of general principles of international law, both categories of law being, like treaties, binding on states. anaya and williams call the declaration a “remedial instrument” because its goal is remedying past dismissal of indigenous peoples’ rights to self-determination so that they “may overcome systemic disadvantage and achieve a position of equality vis-à-vis heretofore-dominant sectors of society.” 2020] the relationship between food sovereignty and hawaiian health 279 law are the “sources of authority.”179 the goal is to safeguard native hawaiian rights in relation to culture, land, and self-governance within the american legal structure.180 according to professor erica daes, the chair of the united nations working group on indigenous populations, this approach highlights a process in which hawaiians, in conjunction with the rest of the united states, could mutually agree upon terms to simultaneously observe their distinctness and include them “in the fabric of the state.”181 in fact, the declaration instructs states to collaborate with native peoples and take the proper actions to ensure indigenous rights and the objective of the declaration.182 furthermore, the declaration compels states to afford “redress, by means that can include restitution or, when this is not possible, just, fair and equitable compensation” for seizing indigenous lands.183 the topic of food sovereignty also cites to the declaration as a foundation; the declaration specifies a number of basic rights indigenous peoples are entitled to, including “the right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions . . . including human and genetic sources, seeds, medicines.”184 further, article 24(1) enumerates the right to “the conservation of their vital medicinal plants, animals, and minerals.185 the united nations continues to develop its efforts to afford indigenous peoples more agricultural rights in 2016, the united nations enforced the “17 sustainable development goals (sdgs)” set out in its 2030 agenda for sustainable development.186 its second sdg seeks to “achieve food security and improved nutrition and promote sustainable agriculture ” in various ways.187 the most pertinent to the issue at hand is as follows: “[b]y 2030, double the agricultural productivity and incomes of small-scale food producers, in particular women, indigenous peoples [emphasis added], family farmers, pastoralists and fishers, including through secure and equal access to land [emphasis added], 179. id. at ii. 180. id. at 6. 181. id. some mandated actions are: to establish a self-governance right in agreement with indigenous peoples’ own cultures and political schemes; and to guarantee a right, if the indigenous peoples’ so desire, to participate in the independent state’s affairs. additionally, states must obtain “free, prior and informed consent” from the indigenous people before approving any legislation or decision that may affect them. 182. id. 183. g.a. res. 61/295, united nations declaration on the rights of indigenous peoples, art. 28(1) (sept. 13, 2007). 184. id. at art. 31(1). 185. id. at art. 24(1). 186. see generally g.a. res. 70/1, transforming our world: the 2030 agenda for sustainable development (sept. 25, 2015). the 2030 agenda for sustainable development was adopted by the general assembly in september 2015. 187. id. at 15. 280 indiana health law review [vol. 17:257 other productive resources and inputs, knowledge, financial services, markets and opportunities.”188 2. decolonization theory decolonization differs slightly from the indigenous peoples’ rights regime; its target varies, but it is generally all residents of hawai#i who have “strong roots in the archipelago.”189 the “source of authority” for decolonization is article 73 of the united nations charter along with other “related united nations declarations and practice;” the goal is creating a mechanism in which hawai#i has the option to change its status to an independent nation-state.190 anaya and williams point out that decolonization and the indigenous peoples’ rights school of thought are both rooted in the self-determination right and remedying historical wrongs, however, decolonization focuses on getting rid of “conditions of classical colonialism in the administration of entire territories that are deemed non-self-governing.”191 in essence, decolonization applies to colonized territories whereas the indigenous peoples’ rights theory applies to “culturally differentiated indigenous peoples within both colonial territories and territories that are deemed fully self-governing as independent or parts of independent states.”192 3. sovereignty and the restoration of the hawaiian monarchy the sovereign hawaiian monarchy is possibly the most popular theory pursued by hawaiian activists; anaya and williams tell us that this theory is “grounded in the states-rights frame of international law (or the law of nations, as the discipline was often called in the late nineteenth-early twentieth centuries)” and rests “on a highly formalistic understanding of the law of nations.”193 188. id. 189. anaya & williams, supra note 24, at 3. 190. id. 191. id. at 15. 192. id. at 15-16. hawai#i was considered a non-governing territory until it became a state in 1959; apparently the united states administered a plebiscite where people had to choose between either “the status quo” and statehood, but independence was not a choice. interestingly, all united states citizens living in hawai#i, including those who had only lived there for a year, were eligible to vote. hawai#i was then taken off the united nations general assembly’s list of non-selfgoverning territories. as a result, some hawaiians demand for the reinclusion of hawai#i on the general assembly’s list and another plebiscite. 193. id. at 19. anaya and williams outline the movement in further detail: the argument claims for hawaii the sovereign prerogatives of an independent state under the monarchy that originated in king kamehameha i and continued through successive heirs to the throne. within this argument, the united states’ presence in [the] hawaii, which came about with the overthrow of the monarchy, represents an illegal occupation and hence the law of nations requires ‘de-occupation’ and effective 2020] the relationship between food sovereignty and hawaiian health 281 supporters of this theory rely on the 1993 congressional apology, which sought to make peace with native hawaiians for the “ramifications of the overthrow for the kingdom of hawaii.”194 moreover, activists in favor of the restoration of the hawaiian monarchy contend that the united states’ “assertion of sovereignty over hawaii” is baseless under international law due to the “illegality” of the overthrow.195 anaya and williams clarify that the indigenous peoples’ rights theory endorses a “hawaiian-led process toward restoration of the monarchy with some level of authority and shared sovereignty, by virtue of the rights of selfdetermination and self-government that are recognized in the un declaration and other sources.”196 the previously discussed theories are grounded in international law, but it is also helpful to look into opportunities founded in american federal law. c. federal recognition the bureau of indian affairs (“bia”) is the go-to federal resource for native american, american indian, and alaska native dealings. their website states: “u.s. supreme court chief justice john marshall articulated the fundamental principle that has guided the evolution of federal indian law to the present: that tribes possess a nationhood status and retain inherent powers of selfgovernment.”197 consistent with this statement, in seminole nation v. u.s., the supreme court noted that the united states has legal and “moral obligations of the highest responsibility and trust” to indian tribes.198 the bureau of indian affairs further stipulated that, per this “federal indian trust responsibility,” the united states possesses a fiduciary obligation to “protect tribal treaty rights, lands, assets, and resources, as well as a duty to carry out the mandates of federal law with respect to american indian and alaska native tribes and villages.”199 a federally recognized tribe is defined as a tribal entity, whether alaska native or native american, “recognized as having a government-to-government relationship with the united states, with the responsibilities, powers, limitations, and obligations attached to that designation, and is eligible for funding and services from the bureau of indian affairs.”200 federally recognized tribes also have self-government rights, such as sovereignty, and have financial assistance and certain protections as a result of their relationship with america.201 currently, restoration of the monarchy. 194. id. 195. id. 196. id. at 21. but, it does not endorse the complete revival of the hawaiian monarchy (should hawai#i achieve independence). 197. frequently asked questions, supra note 25. 198. seminole nation v. united states, 316 u.s. 286, 297 (1942). 199. see frequently asked questions, supra note 25. 200. id. 201. id. 282 indiana health law review [vol. 17:257 there are 573 federally recognized tribes, 229 of which are from alaska.202 the process of federal recognition can be long and complicated; most tribes were able to obtain federal recognition through treaties, acts of congress, executive orders, federal court decisions, or federal administrative actions.203 the office of federal acknowledgement (“ofa”), a branch of bia, handles requests for federal recognition through the federal acknowledgment process.204 public law 103-454, also known as the federally recognized indian tribe list act of 1994, authorized three ways in which a tribe can achieve federal recognition: 1) by an act of congress; 2) administratively through 25 c.f.r. part 83; or 3) by a united states court decision.205 as a reminder, hawaiians have notoriously been excluded from going through the federal recognition process; however, 2016 brought about a new path for hawaiians to pursue in the form of a federal rule.206 and this federal rule could be the first step towards native hawaiian food sovereignty. vi. tying it all together a. the new rule every hawaiian wants what is best for the community, but there are differing views on how to accomplish that – sovereignty, decolonization, indigenous peoples’ rights, and federal recognition all have strong followings.207 those who support federal recognition say that, because native hawaiians programs are being criticized as race-based by a republican congress, they no longer have federal traction.208 on the other hand, critics of federal recognition say that it is not enough, and “‘anything short of self-determination is unprincipled, immoral[,] and illegal.’”209 however, hawaiians struggle to achieve food sovereignty without federal recognition because no land entitlement means little possibility of enforcing traditional agriculture to benefit our indigenous community.210 luckily, there seems to be hope on the horizon for hawaiian food sovereignty with the passing of a new federal rule. in november 2016, hawai#i and the united states made significant progress in providing hawaiians with an opportunity to seek federal recognition equivalent 202. id. alaska region, u.s. dep’t interior: indian affs., https://www.bia.gov/regionaloffices/alaska [https://perma.cc/ehr3-8nea]. 203. id. 204. id. 205. federally recognized indian tribe list act of 1994, pub. l. no. 103-454, §103-04 (1994). 206. see generally 43 c.f.r. § 50 (2016). 207. see rick daysog, na#i aupuni kicks off amid heated talks, hawaii news now (feb. 1, 2016, 3:22am), http://www.hawaiinewsnow.com/story/31104257/nai-aupuni-kicks-off-amidheated-talks/ [https://perma.cc/feu9-kdyc]. 208. id. 209. id. 210. see whyte, supra note 110, at 354. https://www.bia.gov/regional-offices/alaska https://www.bia.gov/regional-offices/alaska 2020] the relationship between food sovereignty and hawaiian health 283 to that of native american tribes with the enactment of 43 c.f.r. § 50, or the procedures for reestablishing a formal government to government relationship with the native hawaiian community. according to the executive summary, the rule: establishes the secretary[’s] . . . administrative process for reestablishing a formal government-to-government relationship with the native hawaiian community to more effectively implement the special political and trust relationship that congress established between that community and the united states. the rule does not attempt to reorganize a native hawaiian government or draft its constitution, nor does it dictate the form or structure of that government. rather, the rule establishes an administrative procedure and criteria that the secretary would use if the native hawaiian community forms a unified government that then seeks a formal government-to-government relationship with the united states. consistent with the federal policy of self-determination and selfgovernance for indigenous communities, the native hawaiian community itself would determine whether and how to reorganize its government.211 in 2010, the house passed a bill discussing native hawaiian government reorganization that was backed by bills from the senate committee on indian affairs and the executive branch.212 the bill provided guidelines for a native hawaiian government, which included self-governing rights under current indian law; it afforded hawaiians protection under the indian civil rights act of 1968 and stated that the native hawaiian government was ineligible for federal indian programs without specific congressional intent.213 further, the bill created a process in which native hawaiians could have the ability to “reorganize a single unified native hawaiian governing entity.”214 then, in 2011, act 195 created the native hawaiian roll commission (also known as kana#iolowalu), which was the state government’s way of supporting the creation of a native hawaiian government eligible for federal recognition.215 211. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. 71278 (oct. 14, 2016) (codified at 43 c.f.r. pt. 50). 212. the bills, however, were not enacted. see id. at 71283. see generally native hawaiian government reorganization act of 2010, h.r. 2314, 111th cong. (2010); native hawaiian government reorganization act of 2009, s.1011, 111th cong. (2010); native hawaiian government reorganization act of 2010, s.3945, 111th cong. (2010). 213. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. at 71283-84. 214. id. at 71284. but see id. (stating there are still congressional members who prefer that hawaiians go through the normal federal acknowledgment process). 215. id. act 195 acknowledged native hawaiians as the only aboriginal people of hawai#i and established a process for “compiling a roll of qualified native hawaiians to facilitate the native hawaiian community’s development of a reorganized native hawaiian governing entity.” 284 indiana health law review [vol. 17:257 kana#iolowalu made an initial list of over 95,000 qualified native hawaiians who were either “pre-certified” on any list managed by oha or registered directly with kana#iolowalu.216 however, act 195, kana#iolowalu, and the 2010 u.s. house bill are independent of 43 c.f.r. part 50.217 the rule recognizes that the “continuity of the native hawaiian community” has been acknowledged by congress in “over 150 separate statutes, which ensures it has a special political and trust relationship with the united states;” still, “a working relationship between government officials is absent.”218 it explains that this relationship has yet to exist because 1893 (the year of the overthrow) is the last time native hawaiians had an organized government; the rule admits the overthrow occurred “when a united states officer, acting without authorization of the u.s. government, conspired with residents of hawaii to overthrow the kingdom of hawaii.”219 the final rule leaves the responsibilities of “convening a constitutional convention . . . drafting a constitution or other governing document for the native hawaiian government . . . registering voters for purposes of ratifying that document . . . electing officers for that government” to the native community and precludes federal government involvement.220 if a native hawaiian governing body is established, it would enjoy the same relationship as that between the united states and federally-recognized tribes, subject to limitations on certain programs, services, and benefits.221 the rule also identifies the two different definitions of “native hawaiian;” under the hawaiian homes commission act, a native hawaiian is someone of at least 50% hawaiian ancestry (otherwise known as “hhca native hawaiians” in the rule).222 the other definition (known as “native hawaiians” in the final rule) is anyone “who is a descendant of the aboriginal people who, prior to 1778, occupied and exercised sovereignty in the area that now constitutes the state of hawaii.”223 the required proof to be classified as an hhca native hawaiian is 216. id. kana#iolowalu has since certified additional lists of qualified native hawaiians available online on their website. certified list as of october 19, 2015, kana#iolowalu (oct. 19, 2015), http://www.kanaiolowalu.org/list/ [https://perma.cc/4pw6-clqx]. 217. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. at 71284. 218. id. at 71278. 219. id. at 71278-79. 220. id. at 71285. the federal government is to only be involved when evaluating the satisfaction of the rule’s requirements and having the secretary of the interior decide whether to restore a formal government-to-government relationship with the newly created native hawaiian government. 221. id. at 71286. the rule also stipulates that the native hawaiian government would “be subject to the same plenary authority of congress” and would “have the same inherent sovereign governmental authorities” as federally recognized tribes. 222. id. see also haw. rev. stat. § 10-2 (2018). 223. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. at 71286. see also haw. rev. stat. § 10-2 (2018). 2020] the relationship between food sovereignty and hawaiian health 285 “documentation demonstrating eligibility under hhca sec.201(a)(7) . . . such as official department of hawaiian home lands (dhhl) records or other state records.”224 to satisfy the native hawaiian classification, the rule requires several things, including generational descent records verified by a state agency or through a kamehameha schools program.225 additionally, this part expresses the federal government’s inability to take land into trust for the potential native hawaiian government; the 1934 indian reorganization act226 does not apply to hawai#i, so the secretary of interior has no power to take lands into trust.227 finally, the final rule lists the seven required elements needed to submit a request to the secretary of interior to reestablish a formal government-to-government relationship.228 these elements include documentation detailing how the native hawaiian community drafted the governing document; documentation detailing who was chosen to ratify the document and why; the actual ratified governing document; and a detailed description of the election process for the government officials listed in the governing document.229 according to professor melody kapilialoha mackenzie, law professor at the university of hawai#i at mânoa william s. richardson school of law and chief editor and author of a number of chapters in native hawaiian law: a treatise, the native hawaiian community held a constitutional convention in february 2016 with participation from those who had signed up on the roll established through act 195 and the kana#iolowalu process.230 she relayed that a constitution was drawn up and the idea was to raise funds, do educational outreach in the native hawaiian community, and eventually hold a ratification vote on the constitution.231 unfortunately, after the 2016 election, and given the uncertainty 224. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. at 71286. 225. id. at 71285-86 (“a native hawaiian may also sponsor a close family relative through a sworn statement attesting that the relative meets the definition of native hawaiian. enumeration in official dhhl records demonstrating eligibility under the hhca also would satisfy the definition of ‘native hawaiian,’ as it would show that a person is an hhca native hawaiian and by definition a ‘native hawaiian’ as that term is used in this rule.”). 226. see generally 25 u.s.c § 5108 (2018). this section of the indian reorganization act allows the secretary of interior to acquire “through purchase, relinquishment, gift, exchange, or assignment, any interest in lands, water rights, or surface rights to lands, within or without existing reservations, including trust or otherwise restricted allotments, whether the allottee be living or deceased, for the purpose of providing land for indians.” 227. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. at 71291. 228. 43 c.f.r. § 50.10 (2019). 229. id. 230. interview, supra note 23. 231. id. a private nonprofit organization put on the constitutional convention based on those 286 indiana health law review [vol. 17:257 of federal policy following president trump’s election, funding became much more difficult.232 in making a decision, the secretary of interior will consider various factors; besides the seven required components, the secretary will examine the number of votes cast in favor of the governing document by native hawaiians if it “exceeded half of the total number of ballots that native hawaiians cast in the ratification referendum,” as long as the amount of votes were enough to “demonstrate broad-based community support among native hawaiians.”233 curiously, the rule also states that the amount of votes cast by hhca native hawaiians will be considered separately.234 b. criticisms while this rule is an impactful step in adjusting the relationship between the united states and hawai#i, it is not perfect. for example, relevant criticism of this rule dealt with land status; § 50.44(f) declares: “reestablishment of the formal government-to-government relationship does not affect the title, jurisdiction, or status of federal lands and property in hawaii.”235 several comments objected to this section of the rule and requested transferring some federal lands to the native hawaiian government.236 the response is that there is a future possibility for the native hawaiian government to secure federal land under certain federal laws, but any revisions to entitlement to federal lands calls for congressional actions.237 related to the theme of this note, commenters indicated the significance of allowing a future native hawaiian governing entity to hold land entitlements because of our spiritual connection to our land.238 the response points to the possibility that a potential native hawaiian sovereign could obtain property through other means not enumerated in the rule.239 also, many comments on the who said they wanted to run as potential native hawaiian sovereign officials as a result of act 195 being challenged in court. 232. id. 233. 43 c.f.r. § 50.16(g) (2019). if there are less than 30,000 votes are cast in favor of the document, then this element is considered unsatisfied; conversely, if more than 50,000 votes are cast in favor of the document, the element is presumed to be satisfied. 234. 43 c.f.r. § 50.16(h) (2019). similar to § 50.16(g), this section of the rule says that the votes in favor of the governing document must exceed half of the total number of votes, as long as the total number of votes were enough to show native hawaiian community approval. further, if less than 9,000 hhca native hawaiian votes are cast in favor of the document, the element is unsatisfied; if more than 15,000 hhca native hawaiian votes are in favor of the document, the element is presumed to be satisfied. 235. 43 c.f.r. § 50.44(f) (2019). 236. procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. at 71305. 237. id. at 71306. 238. id. at 71305. 239. id. at 71305. the rule gives the example of a state provision allowing the transfer of kaho#olawe “to the sovereign native hawaiian entity upon its recognition by the united states and 2020] the relationship between food sovereignty and hawaiian health 287 final rule criticize the distinction between native hawaiians and hhca native hawaiians, calling for the decision on membership to be made by the native hawaiian governing entity itself.240 another concern was raised by professor mackenzie: she noted that this is an administrative rule enacted under the obama administration and will not be tested until a native hawaiian entity seeks to go through the process.241 moreover, because the rule was promulgated by the executive branch, a challenge would be more likely under the theory that that the rule “overreaches” since it is congress that has plenary authority over indian affairs.242 though many are concerned about the implications of this rule, it is likely the most available and practical steppingstone to achieving a native hawaiian sovereign, and more pertinently, food sovereignty. creating a native hawaiian governing entity under the federal regulation could provide a number of jurisdictional solutions for hawaiians: land ownership rights, the power to regulate agriculture, and a right to produce and self-sustain off of culturallyappropriate food.243 and in fixing native hawaiian jurisdictional issues, hawaiian health concerns would also be remedied. essentially, establishing a native hawaiian sovereign would allow for food sovereignty because hawaiians would likely have more land rights and thus will have a right to producing culturallyand nutritionally adequate foods on their own terms. in other words, the land could be used to grow crops that support the traditional hawaiian diet. and in having more access to thd foods, hawaiians with chronic diseases in which dietary changes can have a positive impact (e.g. diabetes and hypertension) would benefit immensely. this proposal can be applied to specific contexts as well, such as the a&b land sale to mahi pono. if a native hawaiian governing entity is created, it is possible that those privately-owned sugarcane lands could transition into trust lands within native hawaiian power. a portion of those trust lands could then become agricultural land for maui farmers to grow taro, breadfruit or purple yams. with a higher production of thd foods comes easier and cheaper access to said foods; this is food sovereignty. and food sovereignty can better supplement programs that work to combat hawaiian health issues, such as the simply health café of hui no ke ola pono. c. conclusion attaining food sovereignty for the benefit of hawaiian health begins with restoring hawaiian land rights, and reclaiming land rights begins with more the state of hawaii.” 240. id. at 71314. many of the responses to the “two types of hawaiians” criticisms reflect the ideal that until the native hawaiian government comes into existence, the baseline criteria will reflect the native hawaiian community and programs that congress has already acknowledged. 241. interview, supra note 23. 242. see id. 243. see bell-sheeter, supra note 11, at 4. 288 indiana health law review [vol. 17:257 political power. seemingly, building a native hawaiian government first, with the hopes of eventual independence, is the most accessible way to do so.244 most hawaiian legal issues are dismissed because we have no political power.245 and yet, there is pushback to the idea of federal recognition for fear of giving up claims of independence.246 however, this proposal does not wish to give up a claim to independence either; rather, it urges native hawaiians to consider looking past our intra-community opinions to work toward one goal: eventual independence. it is easy to dwell on the past wrongs experienced by hawaiians the overthrow of our monarchy, the negative health impacts of a westernized diet, and the setbacks of transitioning to a western land ownership system. the “wrongs” continuously discussed by hawaiian activists are common to all indigenous communities, including those of indiana. similar to what happened with native hawaiians, in the late 18th century, the native americans of indiana came to the realization that the british and american colonists’ main goal was to take native american land.247 the native americans were unfamiliar with the british-american concept of land tenure and fought endlessly with the americans; by 1794, a treaty was drafted and signed, stating that the native americans gave up a strip of land in southeastern indiana in exchange for goods worth $20,000 and an annual payment to all the tribes, ranging from $500$1000.248 the native american leader who signed the treaty, chief little turtle, had the same spirit as queen lili#uokalani in that he hoped signing the treaty would improve the conditions for his people, even though it meant that the americans now had sole authority.249 chief little turtle and queen lili#uokalani did what was best for their people at the time, and the native hawaiian community faces a choice to do what is best for our people now. in order to move forward in reclaiming our identity, health, and land rights, native hawaiians must work with what is available to us: 43 c.f.r. § 50. native hawaiians need access to their own land because it touches all aspects of our health physically, spiritually, mentally, and emotionally.250 while private entities, such as a&b and mahi pono, promise to keep the agricultural integrity of our land and consider the incorporation of traditional 244. interview, supra note 23. 245. see section v, subsection a for examples. 246. see section v, subsection b for theories of hawaiian rights advocacy; anaya & williams, supra note 24. 247. james h. madison & lee ann sandweiss, hoosiers and the american story, 8 (2014), https://indianahistory.org/wp-content/uploads/hoosiers-and-the-american-story-fulltext.pdf [https://perma.cc/d3hx-fxbf]. 248. id. at 11-12. 249. id. at 12. 250. interview, supra note 23. 2020] the relationship between food sovereignty and hawaiian health 289 hawaiian foods into their plans, the reality is that these promises are subject to many variables.251 in other words, this is not food sovereignty. however, with the establishment of a native hawaiian governing entity, the possibility of food sovereignty and a healthier native hawaiian community becomes much more possible because with land, comes power.252 251. see generally uechi, supra note 152; projects, supra note 149. 252. see generally procedures for reestablishing a formal government to government relationship with the native hawaiian community, 81 fed. reg. 71278. extending hoosier hospitality to lgbtq youth: why indiana should pass a conversion therapy ban to protect and promote mental health outcomes for lgbtq youth warren cangany* i. introduction my sessions . . . focused on becoming a “proper woman.” i was told to become more submissive. i remember her saying, “it’s really a blessing we took you out of your leadership roles so guys will be more attracted to you.” the [other] woman focused on changing my physical appearance through feminine clothing and makeup. i soon developed an eating disorder: i don’t have a choice in attending these sessions, i thought, but at least i can control what i eat and throw up.1 gay, lesbian, bisexual, and transgender youth, as well as adolescents questioning their gender identity, gender expression, or sexual orientation (“lgbtq”) “experience significant health and behavioral health disparities. negative social attitudes and discrimination related to an individual’s lgbtq identity contribute to these disparities, and lead to individual stressors that affect mental health and well-being.”2 “today’s lgbtq youth face a variety of stressors – harassment, family and peer rejection, bullying from their peers, isolation and a lack of a sense of belonging – that have a major impact on their overall well-being.”3 along with these challenges, lgbtq youth also face the same age-related developments that accompany adolescence for all youth.4 these challenges include, but are not limited to, processing and expressing gender identity, romantic attraction, and physical changes experienced through puberty.5 however, unlike their heterosexual peers, lgbtq youth must navigate * j.d. candidate, 2021, indiana university robert h. mckinney school of law; b.a., 2011, depauw university. thank you to my family, friends, and the indiana health law review for their support throughout this writing process. a special thank you to my note advisor, professor jennifer a. drobac, samuel a. rosen professor of law at the indiana university robert h. mckinney school of law, for her thoughtful and constructive insight throughout the writing process. 1. amanda loucks, i survived conversion therapy, advocate (aug. 9, 2018), h t tps:/ /www.advocate.com/commentary/2018/8/09/i-survived-conversion-therapy [https://perma.cc/bj56-j3fh] (describing mandatory and weekly conversion therapy sessions). 2. substance abuse & mental health servs. admin., ending conversion therapy: supporting and affirming lgbtq youth 1 (2015) [hereinafter samhsa]. 3. human rights campaign, 2018 lgbtq youth report 6 (2018), https://assets2.hrc. org/files/assets/resources/2018-youthreport-novid.pdf?_ga=2.61088296.526363940.1570234928658909893.1566136340 [https://perma.cc/qd74-upzn]. 4. samhsa, supra note 2, at 2. 5. id. 156 indiana health law review [vol. 18:155 awareness and acceptance of an oftentimes socially marginalized sexual identity or gender expression on top of being a normal adolescent. and, for some lgbtq youth, this minority identity forces them to navigate adolescence without the support of family, local community, or society. this type of chronic stress has become known as minority stress among social scientists.6 it is a high level of stress associated with stigmatized minority groups and has increasingly been linked to damaging mental health outcomes.7 comparing these challenges with those of heterosexual peers, lgbtq youth are at an increased risk for psychological distress and substance abuse behaviors, including depressive symptoms, increased rates of substance use and abuse, suicidal ideation and attempts, as well as increased likelihood of experiencing victimization, violence, and homelessness.8 a recent national survey of 12,000 plus youth conducted by the human rights campaign (“hrc”) in 2018 revealed that 77% reported feeling depressed, 95% reported having trouble sleeping at night, more than 70% reported feeling worthless and hopeless, and 67% reported overhearing negative comments regarding lgbtq people in their home.9 the hrc notes that parents and families play an essential role in promoting adolescent health and well-being, and lgbtq youth that have a family that supports them and accepts their sexual or gender minority identity positively correlates with higher reporting of greater self-esteem and overall lower risk of negative health outcomes such as “depression, distress, hopelessness, and substance use.”10 while advocating for inclusion and acceptance for lgbtq youth does promote more awareness and better overall outcomes, it simply is not enough. lgbtq youth need protection under the law against practices that will be detrimental to their safety and health. this includes anti-discrimination legislation, anti-bully legislation, and a ban on the practice of conversion therapy by licensed mental health providers (“lmhps”). this note’s focus narrows on the legislative efforts to protect and support lgbtq youth. specifically, it considers the impact of a ban on conversion therapy in the state of indiana. it demonstrates that such a ban will lead to better mental health outcomes and overall better health outcomes generally for hoosier lgbtq youth. “[c]onversion therapy—efforts to change an individual’s sexual orientation, gender identity, or gender expression—is a practice not supported by credible evidence and has been disavowed by behavioral health experts and associations.”11 individuals subjected to conversion therapy experience long-term 6. jessica cerretani, pattern constraints, harv. med., https://hms.harvard.edu/magazine/ lgbtq-health/pattern-constraints [https://perma.cc/9zs7-dtf3] (last visited dec. 19, 2020). 7. id. 8. id. 9. see human rights campaign, supra note 3, at 4-7 (providing responses from 12,005 youth aged thirteen to seventeen who identify broadly as lesbian, gay, bisexual, transgender, and/or queer from all fifty states in the united states and the district of columbia). 10. id. at 4. 11. samhsa, supra note 2, at 7 (footnote omitted). 2021] extending hoosier hospitality to lgbtq youth 157 harm, which includes “higher rates of depression, suicidal thoughts, and suicide attempts and lower educational achievement, lower income, and lower work performance into young adulthood.”12 a ban on conversion therapy in the state of indiana for minor children will also prevent uninformed parents or guardians from seeking out the detrimental practice and subjecting their child to irreparable harm. “often these well-meaning parents choose an option that is destructive to their child and family relations because they trust practices that are misleadingly labeled as ‘therapy’ or ‘treatment.’”13 the practice is especially damaging for younger children with studies revealing children exposed to gender expression conversion therapy before the age of ten are four times more likely to attempt suicide.14 if conversion therapy is labeled as illegal, well-meaning and uninformed parents or guardians might pause before attempting to change their minor child.15 in 2018, the hrc released a letter signed by national organizations representing millions of mental health care professionals, educators, and child welfare advocates backing legislative efforts to ban the discredited practice of conversion therapy throughout the united states.16 we emphasize the dangers of sexual orientation and gender identity change efforts, particularly for youth, which include increased risk of anxiety, depression, decreased self-esteem, social withdrawal and isolation, homelessness, substance abuse, and suicidality. sexual orientation and gender identity change efforts present additional, preventable risk factors to lgbt youth, a group that is already at heightened risk for suicide.17 the following professional organizations have issued statements opposing the use of conversion therapy on minors: american academy of child and 12. cerretani, supra note 6. 13. human rights campaign, just as they are: protecting our children from the harms of conversion therapy 4 (2017) [hereinafter just as they are]. 14. cerretani, supra note 6. 15. leila fadel, activists and suicide prevention groups seek bans on conversion therapy for minors, npr (apr. 26, 2019), https://www.npr.org/2019/04/26/716416764/activists-andsuicide-prevention-groups-seek-bans-on-conversion-therapy-for-minors [https://perma.cc/yb49watu]. 16. stephen peters, mental health, child welfare & education orgs back legislative efforts to protect lgbtq youth, hum. rts. campaign (apr. 17, 2018), https://www.hrc.org/pressreleases/national-ch ild-welfare-orgs-back-legislative-efforts-to-protect-lgbtq-youth [https://perma.cc/n4u7-h5l3]. 17. letter from the am. acad. of pas et al. (apr. 17, 2018), https://assets2.hrc.org/files/ assets/resources/national_orgs_letter_in_support_of_legislative_efforts_to_end_conversion _therapy.pdf?_ga=2.28596284.1818856687.1602211879-1707161046.1602211879 [https://perma.cc/q8jp-4a39] (emphasis added). 158 indiana health law review [vol. 18:155 adolescent psychiatry, american academy of pediatrics, american association for marriage and family therapy, american college of physicians, american counseling association, american medical association, american school health association, american psychoanalytic association, american psychiatric association, american psychological association, american school counselor association, and national association of social workers.18 however, despite the overwhelming support from major medical and mental health organizations, innocent children are still being forced into the so-called therapy by lmhps. while a conversion therapy ban will not solve nor completely close the gap between mental health outcomes and health outcomes in general between lgbtq youth and their heterosexual peers, its impact will make a difference. “studies have identified higher rates of psychological distress and psychiatric disorders among lgbtq adults who live in u.s. states that banned same-sex marriage . . . . likewise, state laws that permit the refusal of services to lgbtq people . . . have had damaging psychological effects.”19 a conversion therapy ban not only will protect lgbtq youth, but also, through its expressed impact, promote the reduction of minority stress in lgbtq youth. indiana has the opportunity to be a trailblazer among states to protect and support vulnerable lgbtq youth. lgbtq youth subjected to the harmful practices of conversion therapy are eight times more likely to attempt suicide, six times more likely to report high levels of depression, three times more likely to use illegal drugs, and three times more likely to engage in risky sexual behaviors that lead to a higher risk of human immunodeficiency virus and sexually transmitted diseases.20 the disparity in mental health outcomes, and health outcomes generally, between lgbtq youth and their heterosexual peers is a health care concern. therefore, indiana must protect lgbtq youth by banning conversion therapy provided by uninformed lmhps to promote and protect lgbtq youth in the hoosier state. a. the issue: indiana’s failure to protect lgbtq youth in january of 2019, indiana politicians introduced two bills to ban the practice of conversion therapy by licensed medical professionals.21 advocates of the bans stated that the bills would not cost the state any money and were not uncommon bills.22 however, micah clark, president of the american family association of indiana, a socially conservative organization, challenged the bans. 18. christy mallory et al., ucla sch. l. williams inst., conversion therapy and lgbt youth: update 9 n.17 (2019). 19. cerretani, supra note 6. 20. the lies and dangers of efforts to change sexual orientation or gender identity, hum. rts. campaign, https://www.hrc.org/resources/the-lies-and-dangers-of-reparative-therapy [https:// perma.cc/5c2j-kl4s] (last visited dec. 19, 2020) [hereinafter lies and dangers]. 21. kaitlin lange, lawmakers propose ban on conversion therapy for minors, indy star (jan. 9, 2019), https://www.indystar.com/story/news/politics/2019/01/09/lawmakers-proposesexual-orientation-conversion-therapy-ban/2514253002/ [https://perma.cc/2d2x-jprt]. 22. id. 2021] extending hoosier hospitality to lgbtq youth 159 he claimed the bills would infringe on medical providers’ first amendment rights, more narrowly their freedom of speech.23 senator mark stoops introduced senate bill 284 to amend the indiana code to prohibit the practice of conversion therapy on lgbtq minors in the state of indiana.24 the bill aimed to amend section 25-23.6-11 of the indiana code by adding language that prohibited lmhps from engaging in the practice of conversion therapy with a patient under the age of eighteen.25 the bill also expressly stated that any lmhp who engaged in conversion therapy on a minor would be subject to disciplinary action.26 stoops argued that the bill was necessary because lmhps should not make minors feel unwanted or isolated, especially when lgbtq youth are more likely to experience negative mental health outcomes.27 the bill did not gain any momentum and failed before any committee meetings. indiana house bill 1231 was also introduced at the same time as senate bill 284.28 the bill, which was submitted by representative chris chyung, called for a ban on the practice of conversion therapy by lmhps in the state of indiana.29 house bill 1231 used the exact language as senate bill 284, and it attempted to amend indiana code provisions that regulate professional marriage and family therapists by adding conversion therapy to the chapter of prohibited practices.30 chyung reasoned, “this was one of those things that we saw was a real opportunity to show all hoosier kids that they’re welcome in this [s]tate.”31 the bill did not advance past the introduction phase.32 ultimately, both bills failed because the protection of lgbtq youth is not a high priority in indiana. also, a ban on conversion therapy is currently a stigmatized topic in the state. however, a 2019 report found that hoosier youth are significantly more likely to consider or attempt suicide than their peers in other states.33 one in five hoosier lgbtq youth considers suicide.34 hoosier youth who identify as a sexual orientation minority are five times more likely to attempt suicide than their heterosexual peers.35 youth in indiana, regardless of 23. see u.s. const. amend. i; lange, supra note 21. 24. lange, supra note 21. 25. s.b. 284, 121st gen. assemb., 1st reg. sess. (ind. 2019). 26. id. 27. see lange, supra note 21. 28. see id.; h.b. 1231, 121st gen. assemb., 1st reg. sess. (ind. 2019). 29. lange, supra note 21. 30. h.b. 1231. 31. lange, supra note 21. 32. h.b. 1231. 33. ind. youth inst., 2019 indiana kids count data book: a profile of hoosier youth 126 (2019), https://s3.amazonaws.com/iyi-website/data-book/2019+data+book+/2019_ iyi_databook_022619.pdf [https://perma.cc/f3gy-9qps]. 34. id. 35. id. at 127. 160 indiana health law review [vol. 18:155 whether or not they identify as lgbtq, are taking their own lives at alarming rates compared to their peers in other states.36 indiana missed an opportunity to be an advocate for its youth to promote a healthier and happier state, which includes lgbtq youth living in the state. b. an argument for reform this note advocates for a ban on conversion therapy practices by lmhps and for the protection of lgbtq youth’s mental health outcomes. it discusses the statutes and bills passed by other states to ban the practice of conversion therapy by licensed medical providers. section ii reviews the historical background of the rise and development of conversion therapy in the united states. section iii offers an analysis of the different conversion therapy bans passed in the united states. specifically, this note focuses on california and new jersey laws, as well as the hrc’s call for a complete ban on conversion therapy. section iv argues that indiana has a duty to adopt a conversion therapy ban because no empirical evidence proves that conversion therapy works. indiana must regulate lmhps. indiana also has a duty to protect lgbtq youth. finally, section v advocates that indiana must pass legislation banning the practice of conversion therapy by lmhps and protect lgbtq youth in the state. ii. background the first step – which usually lasted six months – is where they “deconstruct us as a person.” their tactics still haunt me. aversion therapy, shock therapy, harassment and occasional physical abuse. their goal was to get us to hate ourselves for being lgbtq . . . . the second step of the program, they “rebuilt us in their image.” they removed us of everything that made us a unique person, and instead made us a walking, talking, robot for jesus. they retaught us everything we knew. how to eat, talk, walk, dress, believe, even breathe. we were no longer people at the end of the program.37 a. the development of conversion therapy up until the 1970s, homosexuality was deemed by the american psychiatric association to be a certified mental disorder.38 in 1973, however, the american psychiatric association removed it from the diagnostic and statistical manual of mental disorders.39 leading up to that declaration, emerging scientific 36. see generally id. 37. james michael nichols, a survivor of gay conversion therapy shares his chilling story, huffpost (nov. 17, 2016), https://www.huffpost.com/entry/realities-of-conversion-therapy_ n_582b6cf2e4b01d8a014aea66 [https://perma.cc/w6ra-6au3]. 38. samhsa, supra note 2, at 15. 39. judith m. glassgold et al., am. psychol. ass’n, report of the american 2021] extending hoosier hospitality to lgbtq youth 161 evidence and social awareness advocated for the end of sexual orientation discrimination.40 the effort was led by the american psychiatric association and other professional organizations to affirm that homosexuality was not a mental disorder and rejected the stigma of mental illness that medical and mental health professions had previously placed on sexual orientation minorities.41 this change propelled many mental health providers to begin to adopt the position that homosexuality was a normal variation in human sexuality and that sexual minority identities should be affirmed.42 however, despite the affirmation by the american psychiatric association regarding homosexuality, many sexual orientation minorities still faced discrimination and were subjected to outdated social prejudices. for years, lgbtq people have been told that they are abnormal. this negative belief gave birth to the idea that lgbtq people can also be changed or converted to heterosexual or cisgender through what is commonly referred to as conversion therapy, reparative therapy, or sexual orientation change efforts (“soce”).43 this note will use conversion therapy and soce interchangeably. the practice of conversion therapy aims to alter a core component of a person’s identity and attempts “to change a person’s identity from transto cisgender or their orientation from lgb to heterosexual.”44 the practice of conversion therapy has been documented in academic literature as early as the 1890s.45 the practice became common during the 1950s and the 1960s at a time when homosexuality was still branded as a mental disorder.46 the mental illness classification gave rise to the notion that it needed to be cured.47 the first attempts to cure homosexuality included “reversing the effects of pathogenic genetic defects, flawed or excessive parenting, and lasting trauma from sexual abuse” because the cure was based on the idea that reversing those factors would remove individual blocks to heterosexuality.48 over time, the techniques therapists used to try to change sexual orientation and gender identity developed into more drastic and devastating medical measures. these toxic so-called therapy techniques included “inducing nausea, vomiting, or paralysis; providing electric shocks; or having the individual snap psychological association task force on appropriate therapeutic responses to sexual orientation 11 (2009). 40. id. 41. id. 42. id. 43. id. at 71 n.61; samhsa, supra note 2, at 64 (defining cisgender as “[a] person whose gender identity, gender expression, and sex assigned at birth all align.”). 44. cerretani, supra note 6. 45. mallory et al., supra note 18, at 2. 46. glassgold et al., supra note 39. 47. mcdermott will & emery llp, the pernicious myth of conversion therapy: how love in action perpetrated a fraud on america 3 (2018). 48. id. 162 indiana health law review [vol. 18:155 an elastic band around the wrist when the individual became aroused to same-sex erotic images or thoughts. other examples of aversive behavioral treatments included” using shame to create an aversion to same-sex attractions; orgasmic reconditioning; and satiation therapy.49 unfortunately, the federal government also supported the conversion therapy efforts by providing funding to st. elizabeths hospital, which was also known as the “government hospital for the insane,” where lgbtq individuals were subjected to invasive surgical procedures, such as an ice pick lobotomy in hopes of curing homosexuality.50 this barbaric procedure included, “an instrument [being] inserted through the eye socket to detach the frontal lobe of the brain from the hypothalamus, believed to be the source of irrationality.”51 these cruel techniques, which many would consider to be torture, not only had a detrimental impact on the lgbtq individual’s mental health but also led to negative physical health outcomes. the belief of conversion therapy paved the way for perpetuating the negative societal stigmas surrounding the lgbtq community.52 despite the declassification of homosexuality as a mental disorder in 1973, the notion that homosexuality could be cured had become embedded in american culture. and after the american psychiatric association declared that homosexuality was not a mental disorder, love in action (“lia”) took on the mission of curing lgbtq americans.53 lia redeveloped the techniques commonly associated with conversion therapy and implemented techniques that consisted of biblical teachings, spiritual discipline, and a twelve-step program designed to heal.54 the founder of the lia sought out lmhps to staff his programs to promote the idea that his program was credible, despite the american psychologists association’s (“apa”) position against conversion therapy.55 lia employed lmhps with the right credentials who also agreed with lia’s mission and philosophies of curing lgbtq individuals.56 in the twenty-first century, lgbtq youth are realizing and disclosing their minority sexual orientation or identifying as lesbian, gay, or bisexual at younger ages than in previous generations.57 while this trend of lgbtq youth coming out earlier speaks to society’s acceptance of the lgbtq community, it creates a larger vulnerable population that may be subjected to conversion therapy.58 in the early 1990s, the apa noticed the “resurgence of individuals and organizations that actively promoted the idea of homosexuality as a developmental defect or a 49. glassgold et al., supra note 39, at 22. 50. mcdermott will & emery llp, supra note 47, at 6. 51. id. at 6-7. 52. see cerretani, supra note 6. 53. mcdermott will & emery llp, supra note 47, at 13. 54. id. at 12. 55. id. at 16. 56. id. 57. samhsa, supra note 2, at 2. 58. id. 2021] extending hoosier hospitality to lgbtq youth 163 spiritual and moral failing.”59 these anti-gay organizations advocated for psychotherapy coupled with religious ministry to alter a person’s feelings.60 the detrimental practice’s resurgence led the apa to adopt the resolution on appropriate therapeutic response to sexual orientation in 1997.61 this resolution reaffirmed the conclusion “shared by all mainstream health and mental health professions that homosexuality is not a mental health disorder and rejected any form of discrimination based on sexual orientation.”62 additionally, the resolution highlighted many ethical issues surrounding the harmful practice. “in 2009, the apa taskforce on appropriate therapeutic responses to sexual orientation change efforts concluded . . . that no methodologically-sound research on adults undergoing conversion therapy has demonstrated its effectiveness in changing” an individual’s sexual orientation minority identity.63 the amount of physically abusive and physically damaging therapy techniques has drastically reduced today.64 however, conversion therapy has evolved into a talk therapy practice.65 this practice includes training a person to conform to stereotypical gender norms, teaching heterosexual dating skills, and using hypnosis to try to redirect desires.66 although the techniques used today in conversion therapy are “less shocking and extreme,” they still lack an empirical basis for accomplishing their intended goal.67 the williams institute at the university of california, los angeles school of law (the “williams institute”) estimated that 698,000 lgbtq adults have been subjected to conversion therapy in their lifetime.68 this figure includes 350,000 lgbtq adults who experienced detrimental brainwashing during adolescence.69 iii. conversion therapy bans in the united states the therapist ordered me bound to a table to have ice, heat and electricity applied to my body. i was forced to watch clips on a television of gay men holding hands, hugging and having sex. i was supposed to associate those images with the pain i was feeling to once and for all turn into a straight boy. in the end it didn’t work. i would say that it did, just to make the pain go away.70 59. glassgold et al., supra note 39, at 12. 60. id. 61. id. 62. id. 63. samhsa, supra note 2, at 25. 64. just as they are, supra note 13, at 7. 65. id. 66. id. 67. id. 68. mallory et al., supra note 18. 69. id. 70. sam brinton, i was tortured in gay conversion therapy. and it’s still legal in 41 164 indiana health law review [vol. 18:155 conversion therapy has been disavowed by all leading behavioral health experts and health providers. “conversion therapy perpetuates outdated views of gender roles and identities as well as the negative stereotype that being a sexual or gender minority or identifying as lgbtq is an abnormal aspect of human development.”71 conversion therapy is also a practice that is not supported by credible empirical evidence and has been rejected by behavioral health experts and associations.72 moreover, conversion therapy puts young lgbtq people at risk of serious harm and continues to destroy the lives of not only lgbtq individuals but also their families and communities.73 “sometimes [conversion therapy is] the conscious choice of loving parents who think they’re doing what is best for their child but who lack accurate information about its inefficacy and dangers.”74 a. popular culture prompts legislative change conversion therapy found its way into popular culture in 2016 when garrard conley released his memoir recounting his experience with conversion therapy as a teenager.75 at age nineteen, conley was forced into an lia program because his parents could not accept his gay identity.76 lia operated on the misconception that “homosexuality meant unhappiness, isolation and death.”77 while enduring lia’s brainwashing, conley witnessed a mock funeral for a “defector,” which included other patients reading the defector’s obituary.78 lia attempted to control every aspect of conley’s life: where he went, who he spoke to, his grooming habits, and dress code.79 conley was able to escape the program along with his lia handbook, which detailed the destructive techniques.80 the novel was adapted into a golden globe-nominated film in 2018 starring nicole kidman, russell crowe, and lucas hedges.81 conley’s memoir and the film brought awareness to the discredited practice and evoked a call to action around the nation. most recently, the film inspired republican kentucky senator alice states., n.y. times (jan. 24, 2018), https://www.nytimes.com/2018/01/24/opinion/gay-conversiontherapy-torture.html [https://perma.cc/7pce-y9b2]. 71. samhsa, supra note 2, at 1. 72. id. at 7. 73. julie laemmle, california’s conversion: a ban on minor conversion therapy and the effect on other states, 2 ind. j.l. & soc. equality 248, 254 (2013). 74. just as they are, supra note 13, at 4. 75. see garrard conley, boy erased: a memoir (2016). 76. aaron hicklin, i was 19, gay and ready to be ‘cured’ by conversion therapy, guardian (june 10, 2018), https://www.theguardian.com/lifeandstyle/2018/jun/10/i-was-19-gayand-ready-to-be-cured-by-conversion-therapy [https://perma.cc/n7zt-q3uj]. 77. id. 78. id. 79. id. 80. id. 81. boy erased (perfect world pictures 2018). 2021] extending hoosier hospitality to lgbtq youth 165 forgy kerr, a conservative christian, to advocate for a ban in kentucky in 2020 after witnessing the terrible treatment of conley in the film.82 conversion therapy again emerged into popular culture in the film the miseducation of cameron post.83 this movie portrayed a high school girl subjected to conversion therapy practices.84 in 2019, lifetime released a made-for-tv movie, trapped: the alex cooper story based on the memoir by alex cooper, which depicted the harsh and brutal realities of the unregulated practice of conversion therapy.85 cooper, a california native, was only fifteen-years-old when she came out as gay to her mormon family.86 cooper’s parents, distraught with the news, forced cooper to utah to stay with a family her parents believed would be able to cure her.87 cooper’s parents signed the proper guardianship documents to allow the family to enroll cooper into school while staying in utah and left cooper with the family against her will – helpless.88 cooper spent eight months with the family who attempted to cure her through physically and verbally abusive measures.89 in cooper’s devastating memoir, she recalled standing for hours in front of a wall while wearing a backpack full of rocks for days on end, which led her to contemplate suicide. cooper wrote: i just could not do it anymore. i had always had a fighting spirit. even my suicide attempt was in its own way part of my fight to control who i was and where my life would take me. my fighting spirit had gotten me into trouble at times, to be sure. but now i could feel something in me surrendering and lying down.90 cooper eventually was able to break free from the family holding her captive in utah.91 cooper released her memoir in 2016 with hopes that it would bring attention to the detrimental practice of conversion therapy and would help motivate more states to ban the practice.92 cooper has since been able to reconcile 82. trudy ring, a kentucky republican with a gay son wants to ban conversion therapy, advocate (jan. 20, 2020), https://www.advocate.com/politics/2020/1/30/kentucky-republicangay-son-wants-ban-conversion-therapy [https://perma.cc/nx9m-vche]. 83. the miseducation of cameron post (parkville pictures 2018). 84. id. 85. trapped: the alex cooper story (silver screen pictures 2019); see also alex cooper & joanna brooks, saving alex: when i was fifteen, i told my mormon parents i was gay, and that’s when my nightmare began (2016). 86. see cooper & brooks supra note 85. 87. see id. 88. see id. 89. see id. 90. id. at 123-24. 91. id. 92. elizabeth daley, teen forced to carry rocks to ‘cure’ her lesbianism, advocate (mar. 17, 2016), https://www.advocate.com/religion/2016/3/17/teen-forced-carry-rocks-cure-herlesbianism [https://perma.cc/f5qv-hwkb]. 166 indiana health law review [vol. 18:155 with her parents after they abandoned her with the utah family when she was just fifteen-years-old.93 conley and cooper hope their memoirs will bring awareness to the practice of conversion therapy and will make parents think twice before forcing their children into the practice. “they thought they were doing the best thing for me . . . . i think that’s what a lot of parents are under the impression of, that they’re doing the best thing for their child.”94 conley and cooper’s stories reflect an all too common experience for lgbtq youth, who are coerced by family members to undergo the damaging practices.95 in early 2020, conversion therapy reemerged into mainstream media when bowen yang became the first celebrity to share his personal struggle of being forced into conversion therapy as a teenager with the new york times.96 as the newest cast member and first openly gay chinese-american to appear on “saturday night live,” yang used his newfound fame to share his struggle with the life-shattering practice.97 yang was outed to his conservative chinese parents when he was just seventeen-years-old after they discovered an aol instant message conversation between him another man.98 yang recalled the painful experience, “i’d only seen my father cry when my grandpa died and now he’s sobbing in front of me every day at dinner . . . . this is the worst thing you can do as a child of immigrants. it’s just like you don’t want your parents to suffer this much over you.”99 soon after the tearful family meeting, yang’s father enrolled yang into an eight-session conversion therapy program in colorado springs.100 yang completed the program, which he recalled used talk therapy and shaming.101 like many other young lgbtq youths coerced into the detrimental practice, the feeling of family rejection outweighed the present-perceived harm.102 yang went on to attend new york university where he realized he would not be able to ignore his same-sex feelings and that conversion therapy did not cure 93. curtis m. wong, mormon woman exposes barbaric and ‘humiliating’ treatment for being gay, huffpost (mar. 17, 2016), https://www.huffpost.com/entry/saving-alex-mormonteen_n_56ead60ee4b09bf44a9c9152?guccounter=1&guce_referrer=ahr0chm6ly93d3cuz29v z2xllmnvbs8&guce_referrer_sig=aqaaacwavengwydheso9uho9ogiyseanehj4v1x2 pnmhhev20uke8hvbdq7ml034ddtdp_6fblsgblzkxtwjllpsuicu7xcddpwobfuitndx jszwmzdtalhc3-pckkgjh0pirksbdsv6opifuaisvk2avsvhlbyyv49owu01vtjlrbzb [https://perma.cc/k5wh-ltfp]. 94. daley, supra note 92. 95. see wong, supra note 93. 96. maureen dowd, bowen yan of ‘s.n.l.’ is a smash. and a mensch., n.y. times (jan. 25, 2020), https://www.nytimes.com/2020/01/25/style/bowen-yang-snl.html [https://perma.cc/k4aa4e55]. 97. id. 98. id. 99. id. 100. id. 101. id. 102. id.; sanam assil, can you work it? or flip it and reverse it?: protecting lgbt youth from sexual orientation change efforts, 21 cardozo j.l. & gender 551, 561 (2015). 2021] extending hoosier hospitality to lgbtq youth 167 him.103 reflecting back on his experience with conversion therapy, yang said, “it was just crazy. explain the gay away with pseudoscience.”104 conley, cooper, and yang’s experiences with conversion therapy are not uncommon and also demonstrate the many different ways conversion therapy may be practiced around the united states. “most often, young lgbt individuals do not choose to receive reparative therapy voluntarily; rather instead, their family, and mainly their parents, force them to undergo treatment because they do not want to accept that their children are gay.”105 the williams institute estimates that 16,000 lgbtq youth will be forced into conversion therapy programs in states without bans.106 b. conversion therapy visibility creates a wave of change popular culture unveiled these hidden, damaging practices of conversion therapy. conversion therapy no longer only existed in the memories of innocent victims, devastating memoirs, or moving motion pictures. it also appeared in major publications like vogue, teen vogue, the atlantic, time, and people.107 the spotlight on conversion therapy began an undeniable shift in conversion therapy ban legislation as many americans began to advocate for bans. in 2018, the hrc along with numerous national medical and mental health organizations took advantage of conversion therapy’s growing exposure in popular culture and called for legislative action in banning conversion therapy practices.108 currently, twenty states, along with the district of columbia, have banned conversion therapy practices by lmhps on minors. to date, california, colorado, connecticut, delaware, hawaii, illinois, maine, maryland, massachusetts, 103. dowd, supra note 96. 104. id. 105. assil, supra note 102. 106. mallory et al., supra note 18. 107. see lauren sanchez, chloë grace moretz preaches self-love at last night’s new york city premiere of the miseducation of cameron post, vogue (aug. 2, 2018), https://www.vogue. com/article/new-york-city-premiere-the-miseducation-of-cameron-post [https://perma.cc/zg5s3447]; see chelsea greenwood lassman, how conversion therapy came to be, and how it persists today, teen vogue (aug. 7, 2018), https://www.teenvogue.com/ story/how-gayconversion-therapy-came-to-be-and-how-it-persists-today [https://perma.cc/jps7-4baz]; see joseph frankel, more and more states are outlawing gay-conversion therapy, atlantic (july 10, 2017), https://www.theatlantic.com/health/archive/2017/07/states-outlawing-conversiontherapy/533121/ [https://perma.cc/g4w5-xczr]; see mathew shurka, i did conversion therapy for 5 years—now i’m working to end it, time (oct. 27, 2015), https://time.com/4075291/ conversion-therapy/ [https://perma.cc/2k3g-4npb]; see caitlin keating, woman recalls being held against her will during gay conversion therapy as teen: ‘i wanted to die,’ people (nov. 9, 2018), https://people.com/human-interest/girl-15-held-against-her-will-endured-8-months-gayconversion-therapy/ [https://perma.cc/2xmt-ltuv]. 108. just as they are, supra note 13. 168 indiana health law review [vol. 18:155 nevada, new hampshire, new jersey, new mexico, new york, oregon, rhode island, utah, vermont, virginia, and washington have all banned conversion therapy for minors.109 notably, utah is the most conservative state to pass a ban on conversion therapy.110 utah’s conversion therapy ban is an acknowledgment that a ban is a necessary step in protecting lgbtq minors and further demonstrates that this issue crosses political lines.111 the church of jesus christ of latter-day saints also expressed its support for the ban, which many lgbtq advocates tied to the rising suicide rate in utah, especially for minors.112 north carolina has also passed a partial ban on conversion therapy through a recent executive order, which prohibits the use of state funds from being used towards supporting conversion therapy.113 c. california becomes the first state to pass a conversion therapy ban in the united states in 2012, california became the first state in the united states to pass a conversion therapy ban with senate bill 1172 (“sb 1172”).114 sb 1172 prohibits state-licensed health care providers from engaging in conversion therapy with minor youth under the age of eighteen-years-old.115 “under no circumstances shall a mental health provider engage in soce with a patient under [eighteen] years of age.”116 the ban considers the practice of conversion therapy to be “unprofessional conduct” and would subject the health care provider to “discipline by the licensing entity for that mental health provider.”117 senator ted w. lieu’s sb 1172 advocated that not only is conversion therapy scientifically ineffective but it also causes great harm, including rising suicide rates in lgbtq 109. see conversion “therapy” laws, movement advancement project, https://www. lgbtmap.org/equality-maps/conversion_therapy [https://perma.cc/7myu-yukz] (last visited dec. 19, 2020). 110. colin dwyer, utah becomes latest state to ban discredited lgbtq ‘conversion therapy,’ npr (jan. 22, 2020), https://www.npr.org/2020/01/22/798603313/utah-becomes-lateststate-to-ban-discredited-lgbtq-conversion-therapy [https://perma.cc/tb3l-crbb]. 111. id. 112. tara law, why the lds church joined lgbtq advocates in supporting utah’s conversion therapy ban, time (nov. 29, 2019), https://time.com/5741789/utah-conversiontherapy-ban-lds/ [https://perma.cc/hz99-kczy]. 113. tim fitzsimmons, n. carolina is first in south to ban state funding for conversion therapy, nbc news (aug. 2, 2019), https://www.nbcnews.com/feature/nbc-out/n-carolina-firstsouth-ban-state-funding-conversion-therapy-n1038846 [https://perma.cc/j9rg-y8ds]. 114. lgbt policy spotlight: conversion therapy bans, movement advancement project 1 (july 2017), https://www.lgbtmap.org/file/policy-spotlight-conversion-therapy-bans.pdf [https:// perma.cc/2rp2-fp3v]. 115. id. 116. cal. bus. & prof. code § 865.1 (2020). 117. cal. bus. & prof. code § 865.2 (2020). 2021] extending hoosier hospitality to lgbtq youth 169 youth.118 california’s conversion therapy ban was challenged in pickup v. brown. the plaintiffs argued that sb 1172 infringed upon a therapist’s protected speech rights and the parental rights of parents who sought conversion therapy for their minor children.119 the ninth circuit court of appeals held that california’s conversion therapy ban did not violate the free speech rights of soce practitioners or minor parents.120 the ninth circuit failed to find that the practice of conversion therapy was protected speech, which would have triggered strict scrutiny in analyzing the bill’s constitutionality.121 “senate bill 1172 regulates conduct. it bans a form of treatment for minors; it does nothing to prevent licensed therapists from discussing the pros and cons of soce with their patients. senate bill 1172 merely prohibits licensed mental health providers from engaging in soce with minors.”122 the ninth circuit found that sb 1172 sought to regulate the medical profession and, therefore, a rational basis standard applied.123 the ninth circuit distinguished the bill from regulating free speech protections under the first amendment because it did not prevent lmhps from discussing conversion therapy with the public, expressing their personal views about the practice, recommending the practice to patients, or participating in conversion therapy with adults over the age of eighteen.124 sb 1172 regulates mental health treatment and does not regulate lmhps’ free speech.125 further, the ninth circuit “conclude[d] that the first amendment does not prevent a state from regulating treatment even when the treatment is performed through speech alone.”126 the ninth circuit also held that the ban did not violate parents’ fundamental rights furnished by the fourteenth amendment.127 parental rights were established in meyer v. nebraska when the fourteenth amendment was interpreted to provide parents exclusive rights when raising their children.128 the constitution has consistently been interpreted to preserve and protect a parent’s autonomy to direct the care and treatment of his or her child.129 however, despite this consistent recognition, the supreme court has outlined that a state may interfere with this right when it concerns the health or safety of children.130 a 118. assil, supra note 102, at 564. 119. laemmle, supra note 73, at 262. 120. see pickup v. brown, 740 f.3d 1208 (9th cir. 2014). 121. laemmle, supra note 73, at 263. 122. pickup, 740 f.3d at 1229. 123. laemmle, supra note 73, at 263. 124. pickup, 740 f.2d at 1223. 125. id. 126. id. at 1230. 127. see id. 128. meyer v. nebraska, 262 u.s. 390, 398-400 (1923). 129. laemmle, supra note 73, at 256. 130. id. 170 indiana health law review [vol. 18:155 state is empowered to restrict parental rights if it is deemed necessary.131 therefore, the ninth circuit held in favor of sb 1172 because it was within the power and control of the state of california to protect the health and safety of minor children.132 “[t]he fundamental rights of parents do not include the right to choose a specific type of provider for a specific medical or mental health treatment that [a] state has reasonably deemed harmful.”133 the landmark decision affirmed protections for lgbtq youth in california, and it also reaffirmed that conversion therapy was not an acceptable mental health practice.134 d. new jersey stands up to protect lgbtq minors in 2013, new jersey became the second state to ban the practice of conversion therapy on lgbtq minors.135 new jersey passed a ban for imposing soce upon a person under the age of eighteen.136 republican governor chris christie stated that on issues of medical treatment for children we must look to experts in the field to determine the relative risks and rewards. the american psychological association has found that efforts to change sexual orientation can pose critical health risks including, but not limited to, depression, substance abuse, social withdrawal, decreased self-esteem and suicidal thoughts. i believe that exposing children to these health risks without clear evidence of benefits that outweigh these serious risks is not appropriate.137 new jersey’s conversion therapy ban was challenged in king v. governor of new jersey. the third circuit court of appeals held that the state’s conversion therapy ban did not violate lmhps’ first amendment rights to free speech because new jersey’s ban regulated professional speech and not speech generally.138 the third circuit noted this distinction from the ninth circuit’s ruling in 2014 by stating that “the argument that verbal communications become ‘conduct’ when they are used to deliver professional services was rejected . . . . further, the enterprise of labeling certain verbal or written communications [as] ‘speech’ and others [as] ‘conduct’ is unprincipled and susceptible to 131. id. at 257. 132. pickup, 740 f.3d at 1236. 133. id. 134. see id. 135. nancy cutler, new jersey conversion therapy ban stands, for now, but lgbt groups expect more challenges, tyler clementi found. (apr. 19, 2019), https://tylerclementi.org/newjersey-conversion-therapy-ban-stands-for-now-but-lgbt-groups-expect-more-challenges/ [https://perma.cc/4l79-qfgb]. 136. n.j. rev. stat. § 45:1-55 (2020). 137. just as they are, supra note 13. 138. see king v. governor of new jersey, 767 f.3d 216 (3d cir. 2014). 2021] extending hoosier hospitality to lgbtq youth 171 manipulation.”139 the third circuit made a clear distinction between a free citizen’s first amendment right to free speech and the first amendment right to free speech furnished to licensed professionals. the third circuit held “that a licensed professional does not enjoy the full protection of the first amendment when speaking as part of the practices of her profession . . . . [a] professional’s speech warrants lesser protection only when it is used to provide personalized services to a client based on the professional’s expert knowledge and judgment.”140 additionally, the third circuit likened professional speech to commercial speech, which is subjected to intermediate scrutiny and not the strict scrutiny standard that is typically applied to freedom of speech cases.141 the third circuit also emphasized that “regulation of professional speech is spared from more demanding scrutiny only when the regulation was . . . enacted pursuant to [a] [s]tate’s interest in protecting its citizens from ineffective or harmful professional services.”142 this determination by the third circuit provided the foundation for the new jersey conversion therapy ban to withstand the constitutional challenges brought by conversion therapy practitioners. new jersey further upheld lgbtq rights in ferguson v. jonah, when a jury found in favor of a claim, which was brought under new jersey’s consumer fraud act, that a conversion therapy program was fraudulent and unconscionable.143 this case distinguished itself from other conversion therapy ban challenges because it provided a monetary remedy for individuals who had previously participated in conversion therapy and suffered negatively because of it. ferguson v. jonah analyzed the issue from a consumer perspective.144 in ferguson v. jonah, the plaintiffs, who were former male participants of a conversion therapy program offered by jews offering new alternatives for healing (“jonah”), alleged that jonah “engaged in unconscionable practices, deception, fraud, false promises, and misrepresentations in rendering its services.”145 the plaintiffs provided detailed descriptions of the individual and group therapy sessions they experienced, which included being subjected to homophobic slurs, required to remove articles of clothing in group settings while negatively talking about oneself, and subjected to counseling that suggested the plaintiffs spend more time at the gym and naked with their fathers in steam rooms.146 jonah reportedly charged the plaintiffs $100 for individual sessions and $60 for group sessions, and, depending on the individual, the costs could 139. id. at 228. 140. id. at 232. 141. id. at 234. 142. id. at 235. 143. see ferguson v. jonah, 445 n.j. super. 129 (n.j. super. ct. law div. 2014). the program claimed to change individuals from homosexual to heterosexual. id. 144. see id. 145. id. at 139. 146. id. at 134-35. 172 indiana health law review [vol. 18:155 exceed over $10,000 in one year.147 the plaintiffs asserted that because of jonah’s therapy practices, the plaintiffs sought help for increased depression, anxiety, and suicidal thoughts.148 the court denied jonah’s motion for partial summary judgment, emphasizing that “jonah’s conversion therapy damaged the individuals it was meant ‘to cure,’ any subsequent costs of repairing plaintiffs’ mental or emotional health are the direct and proximate result of jonah’s actions, and hence, should be borne by jonah.”149 the third circuit determined that the plaintiffs were able to recover damages sustained from the conversion therapy practices because the damage was quantifiable and could demonstrate an ascertainable loss under new jersey’s consumer fraud act.150 in ferguson v. jonah, the plaintiffs properly established unlawful conduct by jonah, an ascertainable loss by the plaintiffs, and a causal relationship between the unlawful conduct and the loss.151 the decision in ferguson v. jonah not only reaffirmed that conversion therapy is a discredited and harmful practice but also established judicial recognition of the practice as fraudulent because one cannot be cured if one is not truly sick. the supreme court denied certiorari in 2019, leaving the 2013 ban in place.152 despite the persuasive ninth and third circuit decisions upholding the constitutionality of conversion therapy bans, the supreme court in national institute of family and life advocates v. becerra set forth a foundation for successfully challenging state conversion therapy bans. in national institute of family and life advocates v. becerra, the supreme court overturned a ninth circuit decision.153 the ninth circuit previously held that the california reproductive freedom, accountability, comprehensive care, and transparency act did not violate the national institute of family and life advocates’ (“nifla”) first amendment rights by requiring the pro-life clinic to post information about contraception and abortion opportunities.154 the ninth circuit held that the speech being regulated was “professional speech” and, therefore, only subjected to intermediate scrutiny.155 this classification of “professional speech” was similar to the third circuit’s decision in king v. governor of new jersey.156 consequently, the supreme court held that “professional speech” is not 147. id. at 135. 148. id. at 136. 149. id. at 142. 150. see id. 151. id. at 139. 152. susan k. livio, n.j. ban on gay-to-straight conversion therapy for kids won’t be overturned as u.s. supreme court rejects challenge, nj.com (apr. 16, 2019), https://www. nj.com/news/2019/04/nj-ban-on-gay-to-straight-conversion-therapy-for-kids-wont-be-overturnedas-us-supreme-court-rejects-challenge.html [https://perma.cc/b5a2-kfr6]. 153. see nat’l inst. of family & life advocates v. becerra, 138 s. ct. 2361 (2018). 154. see id. 155. see id. 156. see king v. governor of new jersey, 767 f.3d 216 (3d cir. 2014). 2021] extending hoosier hospitality to lgbtq youth 173 a separate category of speech or subject to different rules or protections under the first amendment.157 in a 5-4 opinion penned by justice thomas, the supreme court held that “[t]his court has not recognized ‘professional speech’ as a separate category of speech. speech is not unprotected merely because it is uttered by ‘professionals.’”158 this ruling was considered a huge victory for the pro-life movement, and the state of california could not force pro-life crisis centers to include posters about state-sponsored abortion services.159 however, despite the supreme court finding that professional speech is not a distinct category of speech, the supreme court did recognize two exceptions to the strict scrutiny requirement: commercial speech and professional conduct that involves speech.160 “[c]ommercial speech relates to the compelled disclosure of ‘factual and uncontroversial information.’ the disclosure requirements at issue in [national institute of family and life advocates v. becerra] did not relate to the services provided by the clinic but those by the state.”161 moreover, “[p]rofessional conduct relates to the practice of the profession. the court found the disclosure requirements were not professional conduct: they were ‘not tied to a procedure at all’ and so regulated ‘speech as speech.’”162 the supreme court’s decision in national institute of family and life advocates v. becerra certainly created more obstacles for states when regulating licensed professionals, however, it did not completely rule that conversion therapy bans will fail when challenged.163 the supreme court’s decision in national institute of family and life advocates v. becerra overturned the california decision in pickup v. brown in part for its classification of professional speech.164 the supreme court decision also overturned the third circuit’s decision in king v. governor of new jersey, which distinguished professional speech protections from the strict scrutiny standard.165 while the supreme court’s decision represents, facially, a devastating verdict when considering conversion therapy bans, many first amendment scholars are still confident that conversion therapy bans do not represent first amendment violations.166 the decision in national institute of family and life 157. nat’l inst. of family & life advocates, 138 s. ct. at 2371. 158. id. at 2371-72. 159. emma green, the supreme court hands a win to the pro-life movement, atlantic (june 26, 2018), https://www.theatlantic.com/politics/archive/2018/06/the-supreme-court-hands-awin-to-the-pro-life-movement/563738/ [https://perma.cc/ukf4-muth]. 160. nat’l inst. of family & life advocates, 138 s. ct. at 2372.; melanie griffith, cities are turning on conversion therapy bans, minn. l. rev. (nov. 12, 2019), https://minnesotalawreview. org/2019/11/12/cities-are-turning-on-conversion-therapy-bans/ [https://perma.cc/2yny-xjpx]. 161. griffith, supra note 160 (footnotes omitted). 162. id. (footnotes omitted). 163. id. 164. see pickup v. brown, 740 f.3d 1208 (9th cir. 2014). 165. see king v. governor of new jersey, 767 f.3d 216 (3d cir. 2014). 166. mark joseph stern, bans on lgbtq “conversion therapy” for minors are now under 174 indiana health law review [vol. 18:155 advocates v. becerra can be distinguished from conversion therapy bans simply on the merits of the facts.167 national institute of family and life advocates v. becerra regulates “speech as speech” and does not consider speech as conduct on behalf of licensed professionals.168 conversion therapy bans limit speech as a form of treatment or talk-therapy practice provided to a patient, not simply speech as speech or as a regulation preventing lmhps from speaking about practice.169 many scholars also argue that the bans represent the government’s acknowledgment of a duty to regulate a medical and mental health practice that has been disavowed by every major medical and mental health organization in the united states.170 “[j]ust as doctors can be forbidden from ‘treating’ a broken bone by reciting the lord’s prayer, they can be barred from ‘treating’ lgbtq identity by engaging in discredited coercion.”171 iv. argument: indiana has a duty to pass a conversion therapy ban for licensed mental health care providers the chorus of voices will grow each year, revealing decades of pain, decades lost, families torn apart, relationships ruined because people outside the ex-gay world can never understand what we patients went through.172 as stated previously in this note, hoosier youth are significantly more likely to consider or attempt suicide than their peers living in other states with one in five youth considering suicide.173 hoosier youth who identify as a sexual orientation minority are five times more likely to attempt suicide than their heterosexual peers.174 youth subjected to soce are eight times more likely to commit suicide.175 and, among indiana’s neighboring states, indiana has the highest number of youth who have seriously considered suicide.176 indiana also ranked forty-six in the united states, including the district of columbia, for youth with at least one major depressive episode.177 alarmingly, indiana ranked threat thanks to the supreme court, slate (feb. 1, 2019), https://slate.com/news-andpolitics/2019/02/lgbtq-conversion-therapy-bans-clarence-thomas-supreme-court.html [https://perma.cc/6n85-3xs3]. 167. griffith, supra note 160. 168. id. 169. id. 170. stern, supra note 166. 171. id. 172. conley, supra note 75, at 335. 173. ind. youth inst., supra note 33. 174. id. at 127. 175. just as they are, supra note 13. 176. ind. youth inst., supra note 33, at 128. 177. michele hellebuyck et al., mental health am., the state of mental health in america 17 (2019), https://mhanational.org/sites/default/files/2019-09/2019%20mh%20in 2021] extending hoosier hospitality to lgbtq youth 175 fiftieth in the united states in the same report for youth with severe mental depressive episodes typically triggered by depression compounded by other issues like substance abuse, anxiety, and disorderly behavior.178 there is a clear mental health concern for youth living in the state of indiana that requires state action. the already disturbing suicide rates and mental health concerns are only exacerbated for lgbtq youth living in the state of indiana. it is time for indiana to act to promote well-being for all hoosier youth. as more and more states throughout the united states adopt conversion therapy bans, indiana will likely become a destination state for the uncredited practice. while conversion therapy is currently banned in twenty states in the united states, only one state prevents licensed medical and mental health care providers from referring patients to other states without bans.179 therefore, “individuals will be able to seek therapy in other states, essentially ‘state-forum-shopping’ to receive conversion therapy.”180 presently, delaware is the only state to include prohibitions in its conversion therapy ban to prevent medical and mental health care providers from referring minors to conversion therapy practitioners outside the state of delaware.181 by not passing a conversion therapy ban in indiana, indiana may become responsible not only for the poor mental health outcomes experienced by hoosier minors but also for the poor mental health outcomes of other states’ youth. indiana has a duty to adopt a conversion therapy ban in the state, not only to protect and promote the mental health of hoosier youth but also because the practice is not supported by any empirical evidence. also, the practice is disavowed by all leading medical and mental health professional organizations, and indiana has the ability and duty to regulate licensed mental health providers. a. no empirical evidence proves conversion therapy works in 2009, the apa conducted a peer review of all empirical research on treatment outcomes published from 1960 to 2007 concerning studies that used the following terms: “conversion therapy, sexual orientation, homosexuality, and exgays.”182 the apa reviewed the studies considering three aspects: the efficacy, safety, and harm of soce.183 generally, the apa “found that the low quality of the research on soce [was] such that claims regarding its effectiveness and widespread applicability must be viewed skeptically.”184 the apa addressed the methodological problems with soce research, asserting that “limitations in %20america%20final.pdf [https://perma.cc/s74a-rhzc]. 178. id. at 19. 179. assil, supra note 102, at 569-70. 180. id. 181. del. code ann. tit. 24, § 3510(d) (2020). 182. glassgold et al., supra note 39, at 27 (emphasis omitted). 183. id. 184. id. 176 indiana health law review [vol. 18:155 making casual claims due to threats to internal validity (such as sample attrition, use of retrospective pretests); lack of construct validity, including definition and assessment of sexual orientation; and variability of study treatments and outcome measures” made the findings unreliable and unpersuasive to support that soce is effective.185 the apa also analyzed the efficacy and potential harm of soce and determined that studies “indicate that attempts to change sexual orientation may cause or exacerbate distress and poor mental health in some individuals, including depression and suicidal thoughts. the lack of rigorous research on the safety of soce represents a serious concern . . . .”186 the apa uncovered that the available research did not address diverse populations and the overwhelming majority of individuals studied represented religious-conservative caucasian men who sought out soce.187 the limited and lack of diversity in the population size of those studies also demonstrated that the participants’ motivation to change helped shape the self-reports of perceived sexual orientation change.188 the limited population group of research also demonstrated that those who seek out soce report a higher motivation to change, which led to a positive impact on the participants’ perceived change in sexual orientation.189 however, the apa noted that the various studies indicated “that those who were less religious were more likely to perceive themselves as having an lgb sexual orientation after the intervention.”190 the conflicting results between religiously motivated participants and non-religious participants clearly shaped the perceived sexual orientation change in self-reports, but do not represent an actual change.191 alongside the underwhelming evidence that the tactics used in soce were casually connected to actual changes in sexual orientation, the apa reviewed studies from 2002 and 2004, which demonstrated the harm the practice causes.192 the studies described the detrimental harm that many of the participants experienced through soce, which included increased confusion, guilt, selfhatred, depression, suicidality, and decreased self-esteem.193 also, although the studies reported some benefits associated with patient participation, the apa noted that such might be related to therapy techniques outside the traditional soce structure and that these benefits “can [also] be provided within an affirmative and multiculturally competent framework.”194 the lack of evidence and identifiable positive outcomes led the apa to 185. id. at 34. 186. id. at 42. 187. id. at 45. 188. id. at 50. 189. id. 190. id. 191. id. 192. id. 193. id. 194. id. at 3. such a framework “mitigate[s] the harmful aspects of soce by addressing sexual stigma while understanding the importance of religion and social needs.” id. 2021] extending hoosier hospitality to lgbtq youth 177 firmly reject the practice of soce.195 in doing so, the apa stated that it “consider[s] it inappropriate for psychologists and other lmhp to foster or support in clients the expectation that they will change their sexual orientation if they participate in soce.”196 the apa denounced the practice because it operates based on a foundation that is inconsistent with the scientific and professional consensus that homosexuality is a mental disorder requiring treatment.197 the apa asserted that soce violates the general principles that guide and govern psychologists.198 providing soce services would directly conflict with principle a of the apa ethics code, which “establishes that psychologists aspire to provide services that maximize benefit and minimize harm.”199 the apa noted that the practice reinforces the stigma and discrimination against the lgbtq community.200 the apa also found that soce comes into conflict with principle e, self-determination, which is defined as “the process by which a person controls or determines the course of her or his own life.”201 the apa recognized that clients have a right to designate their own treatment.202 however, lmhps providing soce, despite the harmful impact, would not promote client selfdetermination.203 the lmhp would be neglecting her responsibility to provide competent assessments and interventions that benefit the client rather than harm the client.204 the apa advocated for lmhps to respect and understand religious diversity and how the client’s religious relationship impacts the client’s worldview of the lgbtq community, however, the lmhp should focus on the scientific evidence and use her professional judgment in determining proper mental health interventions.205 narrowing the scope to minor children, the apa firmly asserted that it “conclude[d] that there is no existing research to support the hypothesis that psychotherapy in children alters adult sexual orientation.”206 the apa recommended that lmhps practice affirmative therapeutic interventions for lgbtq minors seeking a change in their sexual orientation or their behavioral 195. id. at 66. 196. id. 197. id. 198. id. at 67. 199. id.; see also am. psychol. ass’n, ethics principles of psychologists and code of conduct 3 (2017), https://www.apa.org/ethics/code/ethics-code-2017.pdf [https://perma.cc/tpt3bxfb]. 200. glassgold et al., supra note 39, at 67. 201. id. at 66. 202. id. at 69. 203. id. 204. id. 205. id. at 70. 206. id. at 73. 178 indiana health law review [vol. 18:155 expression.207 the apa also endorsed identity exploration and development, which includes “offering permission and opportunity to explore a wide range of options and reducing the conflicts caused by the dichotomous or conflicting conceptions of self and identity without prioritizing a particular outcome.”208 this approach supports helping religious individuals with same-sex attractions explore options.209 typically the practice of identity exploration and development is excluded from state bans on conversion therapy.210 the apa recommended that lmhps provide support to children and youth in their developmental processes and milestones, reduce internalized stigmas in children and the stigmas held by their parents, and provide affirming information and education on lgbtq identities and lives.211 any interventions outside of affirmation therapy or identity exploration produced “serious concerns that the coercive or involuntary treatment of children or adolescents has the potential to be harmful and may potentially violate current clinical and practice guidelines, standards for ethical practice, and human rights.”212 the apa’s research and opinions regarding conversion therapy, guided other organizations, including the pan american health organization to denounce the practice in 2012.213 the international public health agency asserted that “[h]omophobic ill-treatment on the part of health professionals or other members of health care teams violates human rights obligations . . . . such treatment is unacceptable and should not be tolerated.”214 most recently, the american medical association (“ama”) voted in 2019 to support state and federal efforts to ban conversion therapy. dr. william e. kobler, an ama board member, stated that “conversion therapy needs to end in the united states given the risk of deliberate harm to lgbtq people . . . . conversion therapy has no foundation as scientifically valid medical care and lacks credible evidence to support its efficacy or safety.”215 in the ama’s brief rejecting conversion therapy, the ama outlined the following ethical concerns regarding the practice. 207. id. at 79-80. 208. id. at 4. 209. marie-amélie george, expressive ends: understanding conversion therapy bans, 68 ala. l. rev. 793, 797 (2017). 210. id. 211. glassgold et al., supra note 39, at 80. 212. id. at 86. 213. pan am. health org., “cures” for an illness that does not exist 3 (2012), https://www.paho.org/hq/dmdocuments/2012/conversion-therapies-en.pdf [https://perma.cc/ at9v-gdmm]. 214. id. 215. tim fitzsimons, american medical association backs nationwide conversion therapy ban, nbc news (nov. 21, 2019), https://www.nbcnews.com/feature/nbc-out/american-medicalassociation-backs-nationwide-conversion-therapy-ban-n1088731 [https://perma.cc/kpn3-2y79]. 2021] extending hoosier hospitality to lgbtq youth 179 [a]dminstering change efforts is an inherently discriminatory practice often administered coercively and fraught with ethical problems, such as: • uninformed consent: change efforts are often prescribed without full descriptions of risk and disclosure of lack of efficacy or evidence • breaches of confidentiality: content of treatment, sexual orientation and gender identity may be shared with family, school or religious leaders without proper consent • patient discrimination: change efforts reinforce bias, discrimination and stigma against lgbtq individuals • indiscriminate and improper treatment: change efforts are recommended regardless of evidence • patient blaming: the failure of treatment may be blamed on the patient it is clinically and ethically inappropriate for health care providers to direct mental or behavioral health interventions, including soce and [gender identity change efforts], with a prescriptive goal aimed at achieving a fixed development outcome of a child’s or adolescent’s sexual orientation, gender identity or gender expression.216 in the ama’s issue brief, the organization outlined a clear commitment to the lgbtq community by adding an explicit opposition to conversion therapy to a recent ama policy, which states that the organization “opposes, the use of ‘reparative’ or ‘conversion’ therapy of sexual orientation or gender identity.”217 the issue brief also outlined the ama’s commitment to educate physicians on the needs of the lgbtq population, increase physician competency on lgbtq health issues, and to collaborate with other organizations to streamline education and research on mutual concerns impacting the lgbtq community.218 “historically, medical professionals have contributed to the stigmatization of lgbtq individuals, so the ama’s active involvement in lgbtq health advocacy is incredibly important . . . .”219 despite the lack of credible or empirical evidence to support the notion that conversion therapy is effective, prominent former leaders of conversion therapy have also discredited it. notably, in 2013, john paulk, a former chairman of exodus international and acclaimed conversion therapy success story, came out 216. lgbtq change efforts (so-called conversion therapy), ama 3 (2019), https:// www.ama-assn.org/system/files/2019-12/conversion-therapy-issue-brief.pdf [https://perma.cc/j8s6f9j6]. 217. id. at 4. 218. see id. at 4-5. 219. fitzsimons, supra note 215. 180 indiana health law review [vol. 18:155 as gay.220 in his formal apology, paulk wrote, “parents, families, and their loved ones were negatively impacted by the notion of reparative therapy and the message of change. i am truly, truly sorry for the pain i have caused.”221 shortly thereafter, alan chambers, the leader of exodus international also rejected conversion therapy, which led to the organization closing.222 in 2014, nine former leaders of leading conversion therapy organizations, including lia and exodus international, released a letter acknowledging the pain and hurt they personally caused and denounced the practice of conversion therapy.223 “as former ‘ex-gay’ leaders, having witnessed the incredible harm done to those who attempted to change their sexual orientation or gender identity, we join together in calling for a ban on conversion therapy.”224 since the 2014 letter, other former leaders have come out not only in opposition to conversion therapy but also as part of the lgbtq community. recently, mckrae game, the leader of hope for wholeness, david matheson, a former mormon conversion therapist, and also randy thomas, the former executive director of exodus international, have all come out against conversion therapy.225 game also exposed the deceptive nature of conversion therapy, stating that “[c]onversion therapy is not just a lie, but it’s very harmful . . . [b]ecause it’s false advertising.”226 based on the lack of empirical evidence for conversion therapy’s efficacy, the overwhelming majority of leading medical and mental health care professional organizations advocating to ban conversion therapy, and the testimony and confessions of prominent ex-conversion therapy leaders, indiana should ban the practice of conversion therapy for lmhps in the state. 220. katie mcdonough, conversion therapy advocate issues formal apology, renounces “ex-gay” past, salon (apr. 25, 2013), https://www.salon.com/2013/04/25/conversion_therapy_ advocate_issues_formal_apology_renounces_ex_gay_past/ [https://perma.cc/7gel-4g3u]. 221. id. 222. tim fitzsimons, ‘doesn’t surprise me’: conversion therapy survivors on another extherapist coming out, nbc news (sept. 4, 2019), https://www.nbcnews.com/feature/nbcout/doesn-t-surprise-me-conversion-therapy-survivors-another-ex-therapist-n1049781 [https://perma.cc/9ry2-vqv3] [hereinafter doesn’t surprise me] 223. former ex-gay leaders unite in opposition to conversion therapy, nat’l ctr. for lesbian rts., http://www.nclrights.org/former-ex-gay-leaders-unite-in-opposition-to-conversiontherapy/ [https://perma.cc/393y-mfs8] (last visited mar. 29, 2020). 224. id. 225. mahita gajanan, ‘i was a religious zealot that hurt people.’ after coming out as gay, a former conversion therapy leader is apologizing to the lgbtq community, time (sept. 4, 2019), https://time.com/5668351/mckrae-game-comes-out-gay-conversion/ [https://perma.cc/4tzlqpuc]; doesn’t surprise me, supra note 222. 226. michael majchrowicz, conversion therapy leader for 2 decades, mckrae game disavows movement he helped fuel, post & courier (aug. 30, 2019), https://www. postandcourier.com/news/conversion-therapy-leader-for-2-decades-mckrae-game-disavowsmovement-he-helped-fuel/art icle_fb56dcfc-c384-11e9-970d-bb9a2a8656c5 .h tml [https://perma.cc/8kya-e66p]. 2021] extending hoosier hospitality to lgbtq youth 181 b. indiana has a duty to regulate licensed health providers indiana has a duty and is permitted to regulate lmhps to promote the best health outcomes for hoosier residents. title 25 of the indiana code has clear and explicit guidelines regulating different licensed professionals in the state of indiana.227 the indiana code outlines regulations for licensed medical professionals, nurses, psychologists, behavioral health and human services, and other licensed professions.228 these codified regulations include governing medical and mental health professions to protect indiana residents from unlawful and unethical practices.229 this note section will focus on the indiana code provisions that apply to marriage and family therapists, and it examines the 2019 politics.230 section 25-19-6.7 of the indiana code gives the state the power to exercise sanctions upon licensed practitioners, more narrowly, marriage and family therapists, if the practitioner performs conduct in direct violation of the statute.231 the practice of conversion therapy directly violates many of the outlined provisions of conduct that would subject a practitioner to sanctions under indiana law. lmhps are in direct violation of section 25-1-9-6.7(2) of the indiana code when the lmhp “fail[s] to meet the minimum standards of performance in professional activities when measured against generally prevailing peer performance in professional activities, including the undertaking of activities that the practitioner is not qualified by training or experience to undertake.”232 the practice of conversion therapy by lmhps would be a direct violation of this section because no educational curriculum for lmhps includes conversion therapy.233 many institutions actually present and instruct the exact opposite of practicing conversion therapy.234 the apa only advocates for affirmative, not conversion, therapy programs for minors seeking guidance for sexual orientation and gender expression identity struggles.235 therefore, any licensed therapist claiming to provide conversion therapy is acting in direct conflict with the therapist’s education and training.236 it would be reckless for the state of indiana to allow licensed professionals to practice a therapy without qualified training, certified education, or experience, especially on vulnerable minor children. section 25-1-9-6.7(3) of the indiana code also comes into direct conflict, 227. see ind. code § 25-0.5-8 (2020). 228. see ind. code § 25-0.5-8-11, 12, 17, 25 (2020). 229. id. 230. see lange, supra note 21. 231. ind. code § 25-1-9-6.7 (2020). 232. ind. code § 25-1-9-6.7(2) (2020). 233. assil, supra note 102, at 572. 234. id. 235. glassgold et al., supra note 39, at 79-80. 236. assil, supra note 102, at 572. 182 indiana health law review [vol. 18:155 stating that a licensed therapist is subject to sanctions if the lmhp “performed services, including any duties required of the individual . . . in reckless disregard of the best interests of a patient, a client, or the public.”237 overwhelmingly, the majority of leading medical and mental health care organizations recognize the detrimental impact conversion therapy has on the lgbtq community.238 any form of conversion therapy is reckless and directly goes against the individual patient’s positive health care needs. “institutions offering such ‘treatment’ at the margin of the health sector should be viewed as infringing the right to health by assuming a role properly pertaining to the health sector and by causing harm to individual and community well-being.”239 indiana has a duty to ban this so-called therapy to prevent the potential harm patients will experience if allowed to be subjected to the treatment. section 25-1-9-6.7(8) of the indiana code would also support a conversion therapy ban. this section subjects therapists to discipline for “willfully plant[ing] in the mind of [a] patient suggestions that are not based in facts known to the [therapist].”240 for an lmhp to suggest that she specializes in conversion therapy or practices conversion therapy would plant in the mind of a patient a false impression, and such is dishonest.241 “[a] mental health practitioner who advertises their ability to ‘cure’ patients that have homosexual attractions is deceptive because they are fraudulently misleading their patients and fabricating unjustified expectations that there is an antidote for being gay.”242 by allowing lmhps to promote the unfounded notion that they can change an individual’s sexuality or gender identity is impractical and creates a gross misrepresentation not supported by any factual evidence.243 finally, a conversion therapy ban in indiana would be supported by section 25-1-9-6.7(9) of the indiana code, which permits sanctions if the lmhp “performed services outside of the scope of practice of the license.”244 section 2523.6-1-7 specifies lmhps to provide therapy that coincides with classifications in the diagnostic and statistical manual of mental disorders and to the extent of the lmhp’s “education, training, experience, and scope of practice.”245 the diagnostic and statistical manual of mental disorders has not classified homosexuality as a mental disorder since 1973, and no accredited educational curriculums provide training on conversion therapy.246 clearly, this section supports a ban on conversion therapy. it is well-defined from the indiana code sections that indiana has the ability and the duty to regulate the practices 237. ind. code § 25-1-9-6.7(3) (2020). 238. see lies and dangers, supra note 20. 239. pan am. health org., supra note 213 (footnote omitted). 240. ind. code § 25-1-9-6.7(8) (2020). 241. assil, supra note 102, at 573-74. 242. id. at 572. 243. id. at 574. 244. ind. code § 25-1-9-6.7(9) (2020). 245. ind. code § 25-23.6-1-7 (2020). 246. samhsa, supra note 2, at 15. 2021] extending hoosier hospitality to lgbtq youth 183 performed by lmhps in the state. a conversion therapy ban also would protect lmhps from being subjected to sanctions of disciplinary action because a ban would absolve lmhps from any pressure from clients to provide the therapy for the client’s minor children. the lmhp would be legally obligated not to practice the detrimental therapy. it would not be an overstep by the indiana legislature to prohibit lmhps from practicing conversion therapy because the practice is fundamentally at odds with what indiana tries to eliminate from practicing lmhps in the state. therefore, the state of indiana should amend section 2523.6-11 of the indiana code to include conversion therapy as a prohibited practice because the indiana code has already provided a strong foundation to regulate lmhps in the state. indiana also is permitted to limit what is deemed a permissible practice provided by lmhps if the limitation or ban serves to protect the public’s health, safety, and welfare.247 the authority for states to regulate lmhps is furnished by the tenth amendment.248 the tenth amendment, which provides states with their police power authority, has been used to justify reporting laws, which require clinicians to report public health risks because the laws and regulations serve the welfare of the public.249 the tenth amendment has also afforded states the ability to limit individual liberties when necessary to safeguard the public’s health and safety.250 in jacobson v. massachusetts, the supreme court acknowledged the states’ rights to regulate certain activities within their state lines, as long as such did not impact the people in other states; “[a]ccording to settled principles, the police power of a state must be held to embrace, at least, such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety.”251 the supreme court further elaborated that the “manner in which those results are to be accomplished is within the discretion of the state . . . only to the condition that no rule prescribed by a state. . . shall contravene the constitution of the united states, nor infringe any right granted or secured.”252 a conversion therapy ban would clearly promote public health and welfare in the state of indiana. conversely, opponents of conversion therapy bans traditionally argue that the bans violate the first amendment rights of lmhps, including infringement upon the freedoms of speech and religion. however, a conversion therapy ban seeks to regulate licensed therapy conduct and does not aim to restrict freedom of speech 247. janet l. dolgin, physician speech and state control: furthering partisan interests at the expense of good health, 48 new eng. l. rev. 293, 322 (2014). 248. u.s. const. amend. x. (“the powers not delegated to the united states by the constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people.”) 249. dolgin, supra note 247, at 336-37. 250. jacobson v. massachusetts, 197 u.s. 11, 25 (1905). 251. id. 252. id. 184 indiana health law review [vol. 18:155 or freedom of religion.253 in the twenty states with conversion therapy bans, lmhps are only prevented from practicing conversion therapy, the bans do not prevent the lmhp from discussing conversion therapy, expressing their views on the practice, recommending patients to unlicensed conversion therapists, nor does it prevent lmhps from providing conversion therapy to adults seeking the treatment who are over the age of eighteen.254 in an amicus brief written by first amendment scholars submitted to the ninth circuit in pickup v. brown, the scholars laid out the foundation that permitted the state of california to allow a conversion therapy ban to stand against challenges of infringement of first amendment rights.255 the scholars cited the supreme court’s holding in giboney v. empire storage & ice co., which asserted that “it has never been deemed an abridgment of freedom of speech or press to make a course of conduct illegal merely because the conduct was in part initiated, evidenced, or carried out by means of language, either spoken, written, or printed.”256 therefore, it would not be an infringement upon lmhps to prohibit conversion therapy because, even though the practice mainly consists of talk therapy today, the state of indiana still has the right to regulate the harmful spoken conduct. the first amendment scholars also cited another supreme court holding that demonstrated that the rule provided in giboney applied to all areas of conduct.257 in ohralik v. ohio state bar association, the supreme court held that “the state [did] not lose its power to regulate commercial activity deemed harmful to the public simply because speech [was] a component of that activity.”258 similarly, conversion therapy is a commercial and professional activity that has been deemed harmful to those subjected to it, which enables state intervention. it does not promote positive mental health outcomes for its patients and only perpetuates negative social stigmas around the lgbtq identity and also fosters homophobia and transphobic ideologies. therefore, the state of indiana is well within its right to prohibit the practice. the amicus brief equated the regulation of lmhps to doctors in malpractice suits by arguing that “[a] doctor surely could not evade a malpractice liability for giving incompetent medical advice—say, advising a patient to take up smoking because the doctor believes it to be healthy . . . .by claiming it was speech and thus protected by the first amendment.”259 it would be hypocritical to provide 253. george, supra note 209, at 823. 254. tiffany graham, conversion therapy: a brief reflection on the history of the practice and contemporary regulatory efforts, 52 creighton l. rev. 419, 424-25 (2019). 255. see brief for amicus curiae of first amendment scholars in support of defendantsappellees supporting affirmance at 7, pickup v. brown, 740 f.3d 1208 (9th cir. 2014) (no. 1217681). 256. id. (quoting giboney v. empire storage & ice co., 336 u.s. 490, 502 (1949)). 257. id. 258. ohralik v. ohio state bar ass’n, 436 u.s. 447, 456 (1978) (holding that the state was able to prohibit solicitation by lawyers). 259. brief for amicus curiae of first amendment scholars in support of defendants2021] extending hoosier hospitality to lgbtq youth 185 first amendment protections to one licensed profession and not another, especially when both licensed professions have the potential to drastically and dramatically impact the health outcomes of their patients. therefore, indiana, through the powers vested by the tenth amendment and as proscribed by the supreme court,260 is permitted to ban conversion therapy. a conversion therapy ban would serve the public health and welfare needs of hoosier residents because the ban seeks to prohibit a practice that is not founded on promoting and achieving positive health outcomes nor is it supported by evidence-based research. c. indiana has a duty to protect lgbtq youth indiana has a duty to protect lgbtq youth and should outlaw harmful therapy practices designed to target and eliminate their existence. youth living in the state of indiana are significantly more likely to consider or attempt suicide than their peers nationally.261 and youth living in the state of indiana that identify as lgbtq are five times more likely than their heterosexual peers to commit suicide.262 it is estimated that 16,000 lgbtq youth will be subjected to conversion therapy in the united states in states without conversion therapy bans.263 in a national survey conducted by the trevor project, two-thirds of lgbtq youth reported that someone tried to change their gender identity or sexual orientation.264 32% of the lgbtq youth respondents reported a suicide attempt within the past year after undergoing conversion therapy.265 according to a recent indiana youth institute report, teen suicide in indiana ranks among one of the highest in the nation.266 based on these statistics, the state of indiana should take action to prevent and reduce the number of teen suicide deaths in the state, regardless of a minor’s sexual orientation or gender identity. appellees supporting affirmance, supra note 255, at 7. 260. without infringing upon the first amendment, the supreme court vests power in the states to regulate speech when deemed actual conduct. 261. ind. youth inst., supra note 33. 262. id. 263. mallory et al., supra note 18. 264. landmark study finds 39 percent of lgbtq youth and more than half of transgender and non-binary youth report having seriously considered suicide in the past twelve months, trevor project (june 11, 2019), https://www.thetrevorproject.org/trvr_press/landmark-studyfinds-39-percent-of-lgbtq-youth-and-more-than-half-of-transgender-and-non-binary-youth-reporthaving-seriously-considered-suicide-in-the-past-twelve-months/ [https://perma.cc/6ene-dezb]. the trevor project’s national survey on lgbtq youth mental health is the largest survey ever conducted on the mental health of lgbtq youth. id. the survey included nearly 35,000 lgbtq youth respondents between the ages of twelve and twenty-four from every state of the united states. id. 265. id. 266. ind. youth inst., supra note 33, at 1. 186 indiana health law review [vol. 18:155 conversion therapy bans “are much more than the four corners of their pages.”267 conversion therapy bans provide expressed acknowledgment and validation to the lgbtq identity, which changes minds and saves lives. “conversion therapy bans send a message to lgbt youth: ‘our state . . . does not see you as “sick” and in need of a cure. we will not allow practitioners to attempt to change you, even if your parents want them to. we see you, and we will protect you.’”268 by not banning the practice, indiana indirectly endorses the practice of conversion therapy and demonstrates its lack of care for lgbtq youth. public opinion would also support a conversion therapy ban. in 2014, a national poll revealed that 63% of americans believe that conversion therapy does not change a person’s sexual identity from gay to straight.269 recent polls in arizona, florida, new mexico, north carolina, pennsylvania, and virginia revealed strong support for conversion therapy bans on youth by lmhps.270 more recently, a 2019 national poll found that 56% of adults in the united states support making the practice of conversion therapy on youth by lmhps illegal.271 this shift in opinion, along with the growing amount of states banning the practice, represents sweeping support that the so-called therapy is ineffective, outdated, and dangerous. v. conclusion eliminating the practice of conversion therapy on sexual and gender minority minors is an important step in promoting better mental health outcomes and health outcomes in general for lgtbq youth. while banning conversion therapy will not completely eliminate the gap in mental health outcomes between lgbtq youth and their heterosexual peers, it will be an important step in the right direction to prevent lgbtq youth from being exposed to outdated stereotypes, feelings of rejection through the veil of therapy, and will eliminate societal bias.272 a conversion therapy ban in the state of indiana would not only protect vulnerable lgbtq minors but it would also – through the ban’s expressive 267. george, supra note 209, at 830. 268. griffith, supra note 160. 269. peter moore, only 8% of americans think gay conversion therapy works, yougov (june 12, 2014), https://today.yougov.com/topics/lifestyle/articles-reports/2014/06/12/gayconversion-therapy [https://perma.cc/qhr2-rgwx]. 270. mallory et al., supra note 18. 271. stonewall anniversary poll 06.06.2019, ipsos (june 6, 2019), https://www.ipsos. com/sites/default/files/ct/news/documents/2019-06/2019_reuters_tracking_-_stonewall_ anniversary_poll_06_07_2019.pdf [https://perma.cc/5akm-fwzb]. the survey includes responses from roughly 2,237 adults age eighteen and older from the united states. id. it also includes 1,972 registered voters who identify as either democrat, independent, or republican. id. 272. samhsa, supra note 2, at 3. 2021] extending hoosier hospitality to lgbtq youth 187 impact – promote eliminating homophobia and negative stigmas generally.273 with indiana’s minor youth suicide rates exceeding national averages, indiana should join the twenty other states in banning the detrimental practice.274 therefore, indiana should pass a conversion therapy ban for lmhps to confirm its commitment to promoting a healthier and happier hoosier state and to support lgbtq youth. 273. see george, supra note 209. 274. see ind. youth inst., supra note 33. a crisis set to repeat itself: improving regulation following the catastrophe of the west calumet housing complex a crisis set to repeat itself: improving regulation following the catastrophe of the west calumet housing complex chelsey lang * i. introduction a. the issue the west calumet housing complex (wchc), public housing located in east chicago, indiana, posed severe environmental and health risks to its residents from the time the project was built. in april 2018, the complex was torn down due to arsenic and lead contamination which posed a risk to residents’ health.1 over the course of the complex’s lifespan at least ninety-five children were confirmed to have elevated blood lead levels and likely suffered adverse health effects. 2 prior to demolition, there were numerous opportunities to prevent residents’ exposure decades sooner, especially given the complex’s land use history as being used for heavy industry and its proximity to contaminated sites. 3 although the destruction of the wchc may seem like a resolution to the long-drawn-out crisis, this crisis is set to repeat across the country. the complex’s story makes clear the numerous problems with how department of housing and urban development (hud) handles environmental contamination of public housing. there are some safeguards that exist today— primarily federal environmental statutes—which would prevent the construction of public housing on contaminated land. yet these safeguards did not ensure the contamination at the wchc was discovered in a timely manner. the absence of a system to check for contamination in older projects means there are likely many current public housing residents being unknowingly exposed to hazardous substances. in february 2020, the u.s. environmental protection agency (epa) and hud found that more than 2,000 public and project-based housing developments are located within one mile of the ————————————————————————————— * j.d. candidate, 2024, indiana university robert h. mckinney school of law; m.a.t. 2018, marian university; b.s., 2016, university of michigan. a special thank you to bill padgett, nermy winner, evan golightly, and my other advisors for their prompt and invaluable comments on this note. 1. samantha horton, demolition begins at contaminated east chicago public housing complex, wfyi indianapolis (apr. 2, 2018), https://www.wfyi.org/news/articles/demolitionbegins-at-contaminated-east-chicago-public-housing-complex [https://perma.cc/9lmm-ausj]. 2. stephanie gosk & corky siemaszko, west calumet housing complex faces wrecking ball due to high lead levels, nbc news (sept. 3, 2016, 7:59 pm), https://www.nbcnews. com/news/us-news/west-calumet-housing-complex-faces-wrecking-ball-due-high-lead-n640766 [https://perma.cc/5nsp-9nkh]; see also agency for toxic sub. & disease registry, u.s. dep’t of health & hum. serv., exposure investigation 4, 6 (may 7, 1998). 3. off. of inspector gen., report no. 2019-oe-0003, contaminated sites pose potential health risks to residents at hud-funded properties 1, 1 (feb. 14, 2021); see also u.s. env’t prot. agency, 315-rico-053j, uss lead feasibility study report 1, 1-6 (june 2012), https://semspub.epa.gov/work/05/941442.pdf [https://perma.cc/4y9j-z5zf] [hereinafter feasibility study report]. https://perma.cc/4y9j-z5zf https://semspub.epa.gov/work/05/941442.pdf https://perma.cc/5nsp-9nkh https://www.nbcnews https://perma.cc/9lmm-ausj https://www.wfyi.org/news/articles/demolition indiana health law review [vol. 21:441 442 country’s most hazardous waste sites and where human exposure was not under control.4 to prevent the wchc’s story from repeating, hud must update and strengthen its regulations to promote communication and cooperation between agencies, the local public housing authority (pha), and residents. one way to do this would be to amend hud regulations to ensure that environmental reviews are performed at all public housing within one mile of hazardous waste sites. in addition, the inclusion of the environmental reviews’ finding should be made a mandatory reporting requirement with each phas’ annual plan. this would improve hud oversight, lead to sanctions and fines for phas out of compliance, and ensure the results are communicated to residents. both the epa and hud have committed to creating healthy environments and communities, 5 but the failure of these agencies to protect residents of public housing must be rectified. given the various limitations associated with civil litigation actions in environmental contaminant cases, a statutory scheme must be adopted by the state of indiana or the federal government, to provide residents relief with fewer barriers. this note suggests using the national childhood vaccine injury act to create an analogous no-fault compensation scheme that, unlike the tort system, would allow harmed residents to recover easily and with certainty. the exposure of tens of thousands of families to hazardous chemicals arising from living in contaminated public housing, 6 and the resultant health impacts they will suffer, is imminent and likely. thus, the solutions advocated for in this note must be realized so that residents of public housing harmed by contamination in the future will not suffer in the same ways those at the wchc did. b. roadmap this note demonstrates, through the drawn-out discovery and cleanup of lead and arsenic contamination at the west calumet housing complex, the failure of hud and the epa to alert and move affected residents. to understand multiple factors that contributed to a public housing complex being built on a contaminated site and then going unaddressed while close to a hundred children were exposed to lead, 7 section ii provides an overview of the wchc’s history. ————————————————————————————— 4. off. of inspector gen., supra note 3, at 16. 5. fy 2022-2026 hud strategic plan, u.s. dep’t of hous. & urb. dev., https://www.hud. gov/hud-fy22-26-strategic-plan-focus-areas [https://perma.cc/d9wt-4kc5] (last visited nov. 20, 2022); see also epa strategic plan, epa u.s. env’t prot. agency (june 13, 2022), https://www.epa.gov/planandbudget/strategicplan [https://perma.cc/6p4c-rkkh]. 6. emily coffey et al., poisonous homes the fight for environmental justice in federally assisted housing, shriver ctr. on poverty l. 1, 2 (june 2020), https://www.povertylaw.org/ wp-content/uploads/2020/06/environmental_justice_report_final.pdf [https://perma.cc/s966-pv he]. 7. gosk & siemaszko, supra note 2; see also agency for toxic sub. & disease registry, supra note 2, at 6. https://perma.cc/s966-pv https://www.povertylaw.org https://perma.cc/6p4c-rkkh https://www.epa.gov/planandbudget/strategicplan https://perma.cc/d9wt-4kc5 https://www.hud 2024] a crisis set to repeat itself 443 an overview of the relevant environmental laws will also be provided, to illuminate which safeguards existed and when. to show the scope and gravity of the contamination, section ii also examines the wchc’s situation more broadly and provides details on health impacts and the make-up of the greater community. section iii analyzes the problems posed by the contamination at the wchc and highlights the fact that action must be taken since the same story is likely to play out again in other parts of the country. most importantly, this section provides support for why and how these problems should be addressed. it offers solutions, focusing on two key aspects that must be addressed. first, hud must close gaps in agency rules by expanding lead testing to include all surface types and more of the toxins most found at hazardous sites near public housing. in addition, hud must require that environmental assessments be performed at public housing near contaminated sites and reported to hud and residents by phas as a part of their yearly plans. second, legislative bodies must adopt a recourse for impacted public housing residents who have been exposed and harmed by contaminated public housing. the section details how this proposed compensation system should be structed so that it would guarantee easy and certain compensation to residents, without needing to prove fault, while also balancing public policy considerations. finally, section iv examines the barriers facing the solutions proposed in this note and the opportunities there might be for progress in the future. ii. background information a. the wchc’s complicated history to understand the problems presented by the wchc this and the following sub-sections will give context to wchc’s history and setting. understanding the details of what happened at one such site, will help show what has likely occurred and will soon surface at many other public housing sites. the wchc opened in 1972 and consisted of 107 residential buildings with a total of 346 units. 8 during the summer of 2016, the epa notified residents it had found lead in the soil with thirty times more lead than is considered safe. 9 at that time, 1,100 tenants lived in the wchc. 10 of these 1,100 tenants, 680 were children and eighty five of those children had elevated levels of lead in their blood. 11 in fact, compared to children living in other parts of east chicago, children living ————————————————————————————— 8. off. of inspector gen., supra note 3, at 1. 9. gosk & siemaszko, supra note 2; see also rosa flores, lead levels in indiana town’s yard 6 times higher than safe, cnn (sept. 1, 2016, 7:30 am), https://www.cnn.com/2016/08/ 30/health/indiana-lead-contamination [https://perma.cc/k8n2-ykgf] (noting that the most contaminated yards tested for lead levels 227 times greater than the epa’s safe lead limit and 135 times greater than the epa’s safe arsenic limit). 10. gosk & siemaszko, supra note 2. 11. off. of inspector gen., supra note 3, at 13. https://perma.cc/k8n2-ykgf https://www.cnn.com/2016/08 indiana health law review [vol. 21:441 444 in the wchc had nearly a three times greater chance of having elevated blood lead levels. 12 the epa’s finding of contamination shocked residents in multiple ways. given how easily children and residents can be exposed to lead, the extremely high levels of lead and arsenic in the soil were frightening to residents. exposure can happen simply by tracking lead particles into one’s home after walking over the soil, or by playing in one’s yard, as children often do. 13 additionally, residents only learned of the test results more than eighteen months after the epa had conducted sampling.14 the epa began sampling in november of 2014 and received the preliminary results between may and october 2015. 15 the final data, however, was not shared with the city of east chicago until may 2016 and then with the residents shortly after. 16 because lead can cause irreversible damage to one’s body and children are the most vulnerable to its effects, 17 residents believe they should have received the results sooner. yet, this was just one instance where residents could have been warned earlier. the wchc’s location and history clearly foreshadowed its potential contamination, but the dangers went unrecognized. the site the wchc was built atop was formerly owned and operated by anaconda lead products and the international smelting and refining company. 18 these companies manufactured, refined, and stored lead primarily for use in lead paint. 19 anaconda lead products was in operation from at least 1938 to 1965, 20 and the international smelting and refining company facility stopped its operations not long after, in 1968.21 hud’s records show that the local pha, the east chicago housing authority (echa), selected the wchc’s site this same year. 22 local phas are government housing agencies, established under state law, 23 that ————————————————————————————— 12. id. 13. lead in soil, cdc ctr. for disease control & prevention (may 2, 2022), https://www.cdc.gov/nceh/lead/prevention/sources/soil.htm [https://perma.cc/9vj6-lefw]. 14. flores, supra note 9. 15. sarah reese, east chicago officials accused epa of ‘breaking trust’ in lead cleanup, nwi.com (mar. 30, 2018), https://www.nwitimes.com/news/local/lake/east-chicago-officialsaccused-epa-of-breaking-trust-in-lead-cleanup/article_f5980b21-069c-5fd4-8890f209363bb296.html [https://perma.cc/em93-flcf]. 16. letter from anthony copeland, mayor, cty. of e.chi, to gina mccarthy, epa adm’r, u.s. env’t prot. agency (july 14, 2016), http://media.wix.com/ugd/d9c0d6_25cb9907943341e 2bfe37ea6e8136ae7.pdf [https://perma.cc/wb5j-3zvx]; see also flores, supra note 9. 17. off. of inspector gen., supra note 3, at 2-3. 18. id. at 1. 19. id. 20. sara burnett & jason keyser, lead crisis in housing project was actually no surprise, ksl.com (sept. 23, 2016, 12:20 am), https://www.ksl.com/article/41587068 [https://perma.cc/ sm4g-p843]. 21. mark johnson et al., health consultation u.s. smelter and lead refinery, u.s. dep’t of health & hum. serv. at 2, 4 (aug. 16, 2018), https://www.atsdr.cdc.gov/hac/pha/uss melterandleadrefinery/us_smelter_lead_refinery_hc_2018-508.pdf [https://perma.cc/zs d5-dk9z]. 22. off. of inspector gen., supra note 3, at 8. 23. ind. code § 36-7-18-4 (2021). https://perma.cc/zs https://www.atsdr.cdc.gov/hac/pha/uss https://perma.cc https://www.ksl.com/article/41587068 https://perma.cc/wb5j-3zvx http://media.wix.com/ugd/d9c0d6_25cb9907943341e https://perma.cc/em93-flcf https://www.nwitimes.com/news/local/lake/east-chicago-officials https://perma.cc/9vj6-lefw https://www.cdc.gov/nceh/lead/prevention/sources/soil.htm 2024] a crisis set to repeat itself 445 provide low-income families and individuals access to public housing. 24 phas assist hud in carrying out its policy of remedying unsafe housing conditions and the shortage of decent, safe, and affordable housing. 25 hud, in turn, provides federal funding to phas to develop and manage public housing. 26 it also grants responsibility and flexibility in administering hud programs to phas that perform well. 27 across the street and directly north of the wchc site, was the u.s. steel (uss) lead facility. 28 this facility served as a lead refinery from 1920 to 1985. 29 a public health assessment by the agency for toxic substances and disease registry (atsdr) has since found that lead-contaminated air created by the site was a hazard to human health from 1920 to 1985. 30 since the wchc site was downwind of the uss lead facility, the atsdr also concluded that lead from the air likely settled onto the complex’s lawn. 31 today, lead particulates are regulated by the clean air act (caa), which authorized the epa to establish national ambient air quality standards to protect public health and the environment. 32 while the caa was passed in 1970, 33 lead was not initially recognized as an air pollutant until the natural resource defense council and other plaintiffs brought suit force the epa to list lead under §108 of the caa. 34 since the epa’s administrator had determined that lead had an adverse effect on public health and its presence in the air resulted from numerous and diverse mobile or stationary sources, the plaintiffs prevailed, 35 and the epa subsequently set primary and secondary air quality standards for lead in 1978. 36 thus, at the very least, the uss lead facility had been emitting lead-laden air onto the wchc property for fifty-eight years, with six of those years overlapping with the time when the first residents lived in the wchc. ————————————————————————————— 24. ind. code § 36-7-18-2 (2021); see also public housing development, u.s. dep’t hous. & urban dev., https://www.hud.gov/programdescription/phd [https://perma.cc/mdt7-rfzr] (last visited feb. 23, 2023). 25. 42 u.s.c. § 1437. 26. id.; see also kate walz & emily coffey, public housing, environmental health, and racism: the west calumet story, strategies for health just.: lessons from the field, at 9, 10 (nov. 2018) (noting that “[i]n 1970, the echa received a $13.4 million grant from hud to build the complex”). 27. 42 u.s.c. § 1437. 28. walz & coffey, supra note 26, at 10; see also off. of inspector gen., supra note 3, at 1. 29. michael brooks & david mellard, agency for toxic sub. & disease registry, pub. health ass’t 1, 2-3 (jan. 27, 2011), https://www.atsdr.cdc.gov/hac/pha/ussmelterandlead refinery/ussleadphablue01272011.pdf [https://perma.cc/24qp-47pv]. 30. id. 31. off. of inspector gen., supra note 3, at 1. 32. 42 u.s.c. § 7409. 33. id. 34. nat. res. def. council, inc. v. train, 411 f. supp. 864, 867 (s.d.n.y. 1976). 35. id. at 870. 36. national primary and secondary ambient air quality standards for lead, 43 fed. reg. 46246 (oct. 5, 1978). https://perma.cc/24qp-47pv https://www.atsdr.cdc.gov/hac/pha/ussmelterandlead https://perma.cc/mdt7-rfzr https://www.hud.gov/programdescription/phd indiana health law review [vol. 21:441 446 when the wchc was built in the early 1970s, and later opened in 1972, 37 not only was its air contaminated; but the echa constructed it on land that had been used to refine lead and arsenic for thirty years. 38 in 1968 when the echa was selecting the wchc site, the link between lead and its adverse health effects were known generally and scientists were collecting data pointing to a clear consensus. 39 yet there was little wider societal concern about childhood lead poisoning. 40 “many considered lead poisoning to be a problem that affected only poor children in slum dwellings.”41 to further illustrate this conundrum: although lead was recognized as a danger in high-dose workplaces during the industrial revolution, lead was commonplace in gasoline and paint. 42 while the science took time to develop, 43 it also took far too much time for the federal government to act on that science. chicago began the first lead poisoning screening programs for children in 1966, 44 though the chicago program likely did not extend to any cities in indiana, despite their proximity. records show that the echa knew locations for public housing projects were limited. 45 the echa also knew the site would likely have to be situated around industry. 46 early deeds show the land was transferred from the international smelting and refining company to another company that manufactured lead and eventually to the blaw-knox company,47 which used lead to craft steel products. so, while the echa might have known from the deeds that this land belonged to multiple companies involved in lead smelting, refining, and manufacturing, it is unclear whether the echa knew the site posed a danger. the echa might not have thought children in their proposed project would be at risk of lead poisoning because the housing would be new and remove children from “slum dwellings” or they may not have considered lead poisoning at all given the lack of general public concern. 48 although the lead-based paint poisoning prevention act ————————————————————————————— 37. off. of inspector gen., supra note 3, at 1. 38. burnett & keyser, supra note 20. 39. herbert l. needleman, human lead exposure 27-28 (1992). 40. id. 41. id. 42. michele augusto riva et al., lead poisoning: historical aspects of a paradigmatic “occupational and environmental disease”, 3(1) safety & health work 11, 13-14 (2012). 43. carrie arnold, the man who warned the world about lead, nova (may 31, 2017), https://www.pbs.org/wgbh/nova/article/herbert-needleman/ [https://perma.cc/h3f4-xeu2] (addressing how lead was suspected in 1943 to have long-lasting effects on children but was confirmed by studies between 1972 and 1979). 44. needleman, supra note 39. 45. public housing sites are scarce, chi. trib. (oct. 6, 1966), https://chicagotribune. newspapers.com/image/196692244/?terms=public%20housing%20sites%20are%20scarce&mat ch=1 [https://perma.cc/hjw8-37sq]. 46. id. 47. ex. a at 1-26, mabry v. cty. of e. chi., no. 2:16-cv-402-jvb-jem (n.d. ind. oct. 20, 2021), https://www.indianaenvironmentalreporter.org/content/posts/20210331-decades-ofmissed-opportunities-exposed-multiple-generations-of-east-chicago-residents-to-leadcontamination-federal-report-finds/exhibita.pdf [https://perma.cc/8jlk-p4sm]. 48. needleman, supra note 39. https://perma.cc/8jlk-p4sm https://www.indianaenvironmentalreporter.org/content/posts/20210331-decades-of https://perma.cc/hjw8-37sq https://chicagotribune https://perma.cc/h3f4-xeu2 https://www.pbs.org/wgbh/nova/article/herbert-needleman 2024] a crisis set to repeat itself 447 banned the use of lead paint in public housing in 1971, 49 this does not necessarily mean the echa was aware of the dangers of lead within soil and air, though in hindsight the pieces were there for echa to have alarm bells sound. today, in compliance with the national environmental policy act (nepa), hud must perform an environmental assessment when a pha proposes constructing new public housing, rehabilitating a property, or changing the land use of a property.50 while nepa will be discussed in more detail in section iv of this note, the environmental assessment must, in part, examine how the environment may affect the project. 51 it would likely unveil contamination or, at least, evidence pointing to contamination. here, echa’s decision to build the wchc and where to build it was approved by hud prior to the adoption of the nepa in 1970.52 had nepa been enacted, an environmental assessment would have been required as part of the hud approval process. 53 however, nepa was not the only environmental statutory safeguard that was not in place when the echa selected the wchc site and built upon it. the resource conservation and recovery act (rcra) of 1976 gives the epa the authority to control the generation, transportation, treatment, storage, and disposal of hazardous waste. 54 rcra primarily “focuses on active and future facilities and generally does not address abandoned or historical sites.”55 the comprehensive environmental response, compensation, and liability act (cercla) of 1980 fills this gap by creating a path to hold statutorily defined parties responsible for cleaning up contaminated sites. 56 cercla established a trust fund, often referred to as the “superfund,” to clean-up hazardous-waste sites as well as releases of contaminants into the environment. 57 the superfund can be used by federal and state governments to finance cleanup actions. 58 under cercla the epa must create a list, known as the national priorities list (npl), which prioritizes sites across the nation with known or threatened releases “of hazardous substances, pollutants, or contaminants.”59 these sites are then often referred to as “superfund sites.” placing a site on the npl, then serves as a necessary precursor to the federal and state governments being able ————————————————————————————— 49. 42 u.s.c. § 4831 (2022). 50. 24 c.f.r. § 50.1 (2023); 24 c.f.r. § 50.17 (2023); 24 c.f.r. § 50.20 (2023). 51. environmental review, hud exch., https://www.hudexchange.info/programs/ environmental-review/ [https://perma.cc/r5yn-686b] (last visited feb. 23, 2023). 52. 42 u.s.c. § 4321 (1970); see also burnett & keyser, supra note 20. 53. 24 c.f.r. §§ 50.17, 50.3 (2023). 54. 42 u.s.c. § 6902 (1984). 55. history of the resource conservation and recovery act (rcra), epa u.s. env’t. prot. agency (dec. 12, 2016), https://19january2017snapshot.epa.gov/rcra/history-resourceconservation-and-recovery-act-rcra_.html#:~:text=rcra%20focuses%20only%20on%20 active,)%20%e2%80%93%20commonly%20known%20as%20superfund [https://perma.cc/3v ut-l5a5]. 56. 42 u.s.c. §§ 9605, 9607 (2002). 57. 42 u.s.c. § 9607 (2002). 58. 42 u.s.c. § 9605 (2002). 59. id.; see also 40 c.f.r. § 300.425 (2022). https://perma.cc/3v https://19january2017snapshot.epa.gov/rcra/history-resource https://perma.cc/r5yn-686b https://www.hudexchange.info/programs indiana health law review [vol. 21:441 448 to obtain financial support for cleanup from parties deemed responsible for contaminating the site. 60 today, nepa, rcra, cercla, and the caa serve as safeguards to control environmental pollution and protect the health of communities by verifying which substances are harmful and making public information about which hazardous substances are being released, where, and in what quantities. 61 this information now serves as a tool that hud can use when conducting environmental assessments or due diligence. 62 when the wchc was built in the early 1970s, and later opened in 1972, the echa and hud did not have the statutory safeguards of nepa or cercla to alert them to the danger of lead contamination, to require them to conduct environmental assessments, or to incentivize them to avoid potential liability. given this historical context, the echa and hud likely did not have bad intentions in building the wchc on top of land heavily connected to lead refining. nor would the echa or hud have had reason to consider the danger until the science supporting the dangers of lead and arsenic was developed and the above environmental regulations were more established. over time the science proving the dangers of lead and arsenic became accepted and environmental statutes were adopted. despite statutory and regulatory safeguards to uncover and address the contamination at the wchc, discovery of the contamination did not come until a long time afterwards. as hud policies for conducting environmental assessments were established, field inspections, research into historic uses, records searches, and tools using data gathered from environmental statutory schemes should have hinted at the contamination at the wchc. nevertheless, because the complex was already built, there was nothing to trigger such investigation until 2003 when echa proposed a rehabilitation of the property. 63 b. the long road to discovering and resolving the wchc contamination the first call for action regarding environmental concerns came in 1985 after the indiana board of health found uss lead in violation of state law and responsible for lead contamination in the area surrounding the refinery. 64 on november 21, 1985, a local representative requested that the epa initiate a hazardous waste removal action under cercla. 65 despite this, it was not until ————————————————————————————— 60. 40 c.f.r. § 300.425 (2022). 61. see generally 42 u.s.c. § 4321; 42 u.s.c. § 6902; 42 u.s.c. § 9601; 42 u.s.c. § 7401. 62. paul mohr et al., evaluating site contamination for hud projects, hud off. of env’t & energy (aug. 22, 2012), https://www.hud.gov/sites/documents/cpd_env_slides8-22. pdf [https://perma.cc/5r3e-9vdf]. 63. feasibility study report, supra note 3, at 11. 64. feasibility study report, supra note 3, at 6. 65. letter from peter visclosky, rep., cong. of the u.s., to valdus adamkus, reg’l adm’r, u.s. env’t prot. agency (nov. 21, 1985), https://bloximages.chicago2.vip.townnews.com/ https://bloximages.chicago2.vip.townnews.com https://perma.cc/5r3e-9vdf https://www.hud.gov/sites/documents/cpd_env_slides8-22 2024] a crisis set to repeat itself 449 1992 that the epa proposed adding the uss lead site to the npl, 66 which would allow the state or federal government to recover cleanup costs. in 1993, the epa pursued cleanup using an alternative method, entering an administrative order of consent (aoc) with uss lead. 67 although the aoc required remediation of the facility under rcra, the cleanup did not extend to residential areas around the site. 68 the extent of the surrounding contamination would not be unveiled until testing occurred in the mid-1990s.69 regardless, the land use history and proximity to the uss lead site should have indicated that immediate testing was necessary. as part of the proposed npl listing, cercla required the atsdr to conduct a health assessment and provide results to the epa and the state of indiana.70 in 1994, atsdr found that lead soil contamination not only posed a danger at the uss lead site, but was also a hazard to those living within a half mile north and northeast of the facility, which encompassed the wchc. 71 it also recommended that the indiana state department of health continue testing local residents’ blood lead levels. 72 in the years following the atsdr’s health assessment, testing of both lead blood levels and surface soil levels in the west calumet area continued. even before the turn of the century, reports indicated abnormal lead levels in throughout the west calumet community. 73 a 1997 lead screening conducted jointly by the east chicago heath department, indiana state health department, and the atsdr found that ten out of thirty children from the wchc and surrounding neighborhoods had lead blood levels at alarmingly high levels. 74 the report attributed the exposure to lead-based paint and soil contamination as possible sources. 75 however, a 1998 exposure investigation report by the u.s. department of health and human services concluded soil samples from the area did not contain lead “at levels of health concern.”76 this conclusion was not only inconsistent with the findings of the 1997 report, but it was also contrary to the 1998 report’s own data.77 it noted there were dangerous ————————————————————————————— nwitimes.com/content/tncms/assets/v3/editorial/9/20/920d1e8a-8c87-5e9e-8e362a5946195bf7/57c9ffffd1728.pdf.pdf [https://perma.cc/4qyj-aqaz]. 66. news release, us. env’t prot. agency, epa proposes 2 midwest sites for superfund list (feb. 7, 1992), https://bloximages.chicago2.vip.townnews.com/nwitimes.com/content/ tncms/assets/v3/editorial/e/97/e9708b38-aeeb-522f-b214-c69f8add8e52/57c87f287cd67.pdf.pdf [https://perma.cc/jy44-pn4d]. 67. feasibility study report, supra note 3, at 6. 68. feasibility study report, supra note 3, at 6. 69. brooks & mellard, supra note 29, at 14. 70. 42 u.s.c. § 9604 (2018). 71. brooks & mellard, supra note 29, at 14. 72. id. 73. agency for toxic sub. & disease registry, supra note 2, at 6. 74. id. 75. id. 76. id. 77. id. https://perma.cc/jy44-pn4d https://bloximages.chicago2.vip.townnews.com/nwitimes.com/content https://perma.cc/4qyj-aqaz https://nwitimes.com/content/tncms/assets/v3/editorial/9/20/920d1e8a-8c87-5e9e-8e36 indiana health law review [vol. 21:441 450 soil lead levels an elementary school just across the street from the wchc and that surface soil lead level samples were not actually taken in the vicinity of the tested children’s homes. 78 the 1998 report was also inconsistent with additional data from 1990 to 1997, which indicated that the west calumet area had higher blood lead levels compared to average state-wide data. 79 starting in 2003, the echa rehabilitated the wchc property, which triggered requirements to conduct environmental reviews. 80 as discussed earlier, this should have uncovered the contamination; however, the reviews were not conducted properly. 81 this allowed the echa to complete rehabilitation projects between 2003 and 2016 without discovering the site contamination. 82 in 2003, the epa conducted soil sampling focused on 83 residential properties near the wchc. 83 more than half were found to have soil exceeding the safe level of 400mg/kg of lead for residential soils. 84 just below this level, from 150mg/kg to 400mg/kg, children should wash their hands when playing outside and gardening practice must be modified to produce safe food. 85 above 400mg/kg abatement or remediation actions must be conducted and children should be restricted or prohibited from playing in the area. 86 the high lead soil levels led to the cleanup of fifteen residential properties and other nearby industrial sites also contaminated with lead. 87 the history of industrial land use, alarming child blood lead levels, and remediation of surrounding areas should have prompted earlier action. instead, soil testing did not occur on the wchc property until after it became a cercla superfund site six years later.88 though the uss lead site had been pending placement on the npl since it was first proposed in 1992, it was not until april 2009 that the epa placed the tracts of land containing the former uss lead facility, as well as the wchc, on the npl. 89 from december 2009 to september 2010, an epa contractor collected soil samples for lead and arsenic across the tract of land containing the wchc, known as operating unit 1 (ou1) of the uss lead superfund site. 90 yet ————————————————————————————— 78. id. 79. id. at 5. 80. off. of inspector gen., supra note 3, at 11; see also 24 c.f.r. §§ 50.3, 50.17 (2023). 81. off. of inspector gen., supra note 3, at 11-12. 82. id. at 11-13. 83. feasibility study report, supra note 3, at 6. 84. id. 85. richard stehouwer & kirsten macneal, lead in residential soils: sources, testing, and reducing exposure, pennstate extension (sept. 15, 2010), https://extension.psu.edu/lead-inresidential-soils-sources-testing-and-reducing-exposure [https://perma.cc/5ajv-bupk]. 86. id. 87. feasibility study report, supra note 3, at 7. 88. off. of inspector gen., supra note 3, at 10. 89. memorandum from douglas ballotti, acting dir., superfund div., to mathy stanislaus, assistant adm’r, off. of land & emergency mgmt. 8 (oct. 24, 2016), https://semspub. epa.gov/work/05/929998.pdf [https://perma.cc/5jdv-9sns]. 90. feasibility study report, supra note 3, at 8. https://perma.cc/5jdv-9sns https://epa.gov/work/05/929998.pdf https://semspub https://perma.cc/5ajv-bupk https://extension.psu.edu/lead-in 2024] a crisis set to repeat itself 451 it was not until 2012, within a feasibility study report, that the epa summed up the finding of the 2009-2010 sampling.91 all samples taken in the wchc exceeded the safe level for lead.92 furthermore, the wchc samples were found to have the highest arsenic and lead concentrations in all of ou1. 93 despite this finding, wchc residents, the east chicago housing authority, and the city of east chicago were not directly notified of the danger by the epa. the epa’s 2012 record of decision (rod) clearly states that the yards in ou1 were contaminated “with lead and arsenic at levels that pose a threat to human health via ingestion, inhalation, and direct contact.”94 the rod also determined a remedy or cleanup plan to address the contamination. 95 thus, at the time the epa conducted additional sampling in 2014, it was aware of the threat to human health and primarily conducted additional sampling to cover properties “[with]in the public housing area that were not previously tested.”96 as mentioned earlier, it was not until 2016 that the city of east chicago and wchc residents were notified of the complex’s high lead and arsenic soil levels by the epa.97 upon receiving the 2014 data from the epa, east chicago’s mayor, anthony copeland, responded to the agency blaming it for the crisis at the wchc and specifically pointing to its inadequate cleanup plan, slow response, and lack of communication. 98 copeland also requested that before any remediation took place that wchc residents be relocated first. 99 following the request, hud provided $1.9 million in rent vouchers and $400,000 for relocations specialists to assist wchc residents in finding new housing. 100 although hud gave wchc residents assistance in finding new housing, their options were limited. 101 to expand residents’ options, hud said residents could move to illinois, but moving states could cost residents in other ways, such a ————————————————————————————— 91. id. at 5-6, 8. 92. id. at 8-9. 93. id. at 8. 94. u.s. env’t prot. agency region 5, uss lead record of decision 1, 4 (nov. 2012), https://semspub.epa.gov/work/05/446987.pdf [https://perma.cc/6p9f-avel]. 95. id. 96. fact sheet, agreement helps start project to clean up contaminated soil, u.s. env’t prot. agency (nov. 2014), https://semspub.epa.gov/work/05/919976.pdf [https://perma.cc/ 3db6-a5sl]. 97. gosk & siemaszko, supra note 2; see also letter from copeland, supra note 16. 98. letter from copeland, supra note 16; see also letter from anthony copeland, mayor, city. of e. chi., to robert kaplan, epa region 5 acting reg’l adm’r (june 16, 2016), http://media.wix.com/ugd/d9c0d6_cd6fc9810bdb4bf089c75fe00d3cf078.pdf [https://perma.cc/jb2m-n434]. 99. letter from copeland, supra note 16. 100. flores, supra note 9. 101. tom davies, dozens of families remain at lead-tainted east chicago complex, wbezchicago (mar. 31, 2017, 12:07 pm), https://www.wbez.org/stories/dozens-of-familiesremain-at-lead-tainted-east-chicago-complex/64812a26-02cf-4931-8e52-af892e3e94b3 [https:// perma.cc/96xw-mr7h] (noting that there are “limited rental options in the formerly industrial area [and] landlords who will not accept government housing vouchers”). https://www.wbez.org/stories/dozens-of-families https://perma.cc/jb2m-n434 http://media.wix.com/ugd/d9c0d6_cd6fc9810bdb4bf089c75fe00d3cf078.pdf https://perma.cc https://semspub.epa.gov/work/05/919976.pdf https://perma.cc/6p9f-avel https://semspub.epa.gov/work/05/446987.pdf indiana health law review [vol. 21:441 452 losing their local communities, jobs, and medicaid coverage. 102 it was only after residents were moved out and the demolition of the complex had been approved that hud completed its own environmental site assessment, further confirming the incredibly high soil concentrations of lead and arsenic. 103 the epa has since said that it is working to institute processes that, in situations like these, would involve using preliminary data to spur immediate action, rather than waiting until the data is fully assessed. 104 the story of the wchc encapsulates the lack of communication and cooperation between hud and the epa, as well as between those agencies, the echa, and residents. the failures by numerous parties in varying degrees over almost half a century since the complex was built, have resulted in challenges in holding culpable parties accountable. most significantly, the crisis demonstrated the lack of safeguards protecting residents of public housing and requires solving the problems that have been made apparent. thus, the first solution this note proposes is to make environment reviews required at public housing complexes within one mile of a superfund site and to include the results within each phas’ annual plan. expanding hud regulation so that environmental reviews do not overlook the surfaces children play on and the types of contaminants most often found at superfund sites, will also close additional gaps. c. understanding the wchc within the broader context lake county hosts “three of the nation’s largest integrated steel mills, one of the world’s largest oil refineries, several coal-fired power plants, and countless industrial facilities.”105 in addition to the uss lead site, there are six active superfund sites within lake county, 106 many of which have been the source of consent decrees and litigation. the epa’s toxic release inventory (tri) program shows that in 2021 there were 97 different toxic chemicals ————————————————————————————— 102. id. 103. lewis mason, phase ii environmental site assessment west calumet housing complex, hud exchange 1, 1 (feb. 15, 2017), https://www.hudexchange.info/sites/onecpd/ assets/file/segment-001-of-phase-ii-report-west-calumet-housing-17.1151.2.pdf [https:// perma.cc/gtl8-u5dv] (prepared for east chicago housing authority). 104. flores, supra note 9. 105. assessment of environmental justice needs in northern lake county communities, hoosier env’t council, https://www.hecweb.org/wp-content/uploads/2019/03/hecassessment-of-ej-needs-in-northern-lake-county-communities-final-report2.pdf [https://perma.cc/f8ev-y7pp] (last visited mar. 28, 2023). 106. search for superfund sites where you live, epa u.s. env’t. prot. agency (sept. 2, 2022), https://www.epa.gov/superfund/search-superfund-sites-where-you-live [https://perma.cc/ z2da-jhw7] (choose “indiana” from the select a state dropdown; click “go”; then search in search bar “lake”). https://perma.cc https://www.epa.gov/superfund/search-superfund-sites-where-you-live https://perma.cc/f8ev-y7pp https://www.hecweb.org/wp-content/uploads/2019/03/hec https://www.hudexchange.info/sites/onecpd 2024] a crisis set to repeat itself 453 released in lake county, totaling 16.5 million pounds of pollutants. 107 when a toxic chemical has been emitted, either into air or water, or “placed in some type of land disposal,” it qualifies as a release. 108 the chemicals listed within the tri program “cause one or more of the following: 1) cancer or other chronic human health effects; 2) significant adverse acute human health effects; or 3) significant adverse environmental effects.”109 of those pollutants released on-site by generators, the greatest proportion of toxic contaminants is released as land pollution, followed by air, then water pollution. 110 according to the u.s. census bureau, 15.8% of lake county’s population is living in poverty. 111 yet when east chicago is looked at in isolation, this figure doubles. 112 east chicago is also made up a significantly larger proportion of african americans and latinos than compared to lake county and the state of indiana as a whole, as indicated by the chart below. 113 east chicago lake county indiana african american 36% 24.5% 10.2% latino 57.5% 20.4% 7.7% white 6.3% 53% 77.5% in one of his letters to the epa, mayor copeland refers to the wchc as an “environmental justice community.”114 in making this statement, copeland was not only referring to the fact that east chicago is a low-income community of color, but also that the epa should be prioritizing this community, consistent with its internal goals. the epa defines “environmental justice” as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and ————————————————————————————— 107. tri explorer releases: chemical report, epa u.s. env’t. prot. agency (oct.15, 2022), https://enviro.epa.gov/triexplorer/release_chem?p_view=coch&fld=&trilib=triq1& tab_rpt=1&linespp=&sort=re_tolby&industry=all&sort_fmt=2&topn=&state= 18&county=18089&chemical=all+chemicals&year=2021&report=&bgcolor=%23d0e 0ff&foregcolor=black&font_face=arial&font_size=10+pt&font_width=nor mal&font_style=roman&font_weight=bold [https://perma.cc/4dgu-f676]. 108. what is the toxics release inventory?, epa u.s. env’t. prot. agency (jan. 25, 2023), https://www.epa.gov/toxics-release-inventory-tri-program/what-toxics-release-inventory [https://perma.cc/5393-guaa]. 109. tri-listed chemicals, epa u.s. env’t. prot. agency (aug. 11, 2022), https://www.epa.gov/toxics-release-inventory-tri-program/tri-listed-chemicalsd [https://perma. cc/87da-rd5z]. 110. tri explorer 2021 tri factsheet: county – lake, in, epa u.s. env’t. prot. agency, https://enviro.epa.gov/triexplorer/tri_factsheet.factsheet?pzip=&pstate=in&pcity=&pcounty=la ke&pyear=2021&pparent=tri&pdataset=triq1 (last visited nov. 20, 2022). 111. quickfacts indiana; east chicago city, indiana; lake county, indiana, u.s. census bureau, https://www.census.gov/quickfacts/fact/table/in,eastchicagocityindiana,lakecounty indiana/rhi125221 [https://perma.cc/a83q-n5mk] (last visited nov. 20, 2022). 112. id. 113. id. 114. letter from copeland, supra note 16. https://perma.cc/a83q-n5mk https://www.census.gov/quickfacts/fact/table/in,eastchicagocityindiana,lakecounty https://enviro.epa.gov/triexplorer/tri_factsheet.factsheet?pzip=&pstate=in&pcity=&pcounty=la https://perma https://www.epa.gov/toxics-release-inventory-tri-program/tri-listed-chemicalsd https://perma.cc/5393-guaa https://www.epa.gov/toxics-release-inventory-tri-program/what-toxics-release-inventory https://perma.cc/4dgu-f676 https://enviro.epa.gov/triexplorer/release_chem?p_view=coch&fld=&trilib=triq1 indiana health law review [vol. 21:441 454 enforcement of environmental laws, regulations, and policies.”115 according to the epa, this can only be achieved when “everyone enjoys the same degree of protection from environmental and health hazards, and equal access to the decision-making process to have a healthy environment in which to live, learn, and work.”116 as policies around environmental justice grow, the story of the wchc epitomizes how unequal access to affordable, safe housing corresponds with environmental and health issues. d. the potential for serious health impacts the specific health impacts suffered by former residents of the wchc is not publicly available. apart from blood testing that has shown elevated blood lead levels in residents,117 a group of wchc residents have asserted suffering emotional distress, driven by their fear that they or a closely related person will contract a future disease or illness because of the lead and arsenic exposure. 118 the scope and severity of health impacts cannot be known at this time. often cases of environmental contamination pose special challenges concerning latency, which is the unknown period between exposure to a toxic substance and the development of associated diseases and conditions. 119 for each individual exposed, the disease or condition that arises as well as the latency period can vary, or the disease or condition may never manifest. however, given the harmful levels of lead and arsenic found at the wchc, and given the potential for others living near superfund sites to be exposed to these substances, 120 one should understand the health risk these substances can pose. as part of the 1986 amendments to cercla, congress mandated the atsdr produce peer-review profiles of the hazardous substances found at superfund sites, including lead and arsenic. 121 lead-based paint in pre-1978 ————————————————————————————— 115. environmental justice, epa u.s. env’t. prot. agency (sept. 30, 2022), https://www. epa.gov/environmentaljustice [https://perma.cc/k7qt-ba92]. 116. id. 117. e-mail from motria caudill, env’t health scientist, agency for toxic substances & disease registry, to michael ribordy, chief of emergency response section #3, u.s. env’t prot. agency region 5 (sep. 14, 2016, 12:56 pm), https://semspub.epa.gov/work/05/929439.pdf [https://perma.cc/3pp9-cpuq]. 118. mabry v. cty. of e. chi., no. 2:16-cv-402-jvb-jem, 2021 wl 5141371 (n.d. ind. oct. 20, 2021) (residents filed suit against the city of east chicago, its mayor, the echa and its director, and numerous lead and arsenic manufactures, alleging that the defendants should have known of the serious environmental problem and that unreasonably dangerous conditions existed at the wchc). 119. margie searcy-alford, a guide to toxic torts § 10.06 (2022). 120. coffey et al., supra note 6, at 11. 121. u.s. dep’t of health & hum. ser., toxicological profile for lead vi (aug. 2020), https://www.atsdr.cdc.gov/toxprofiles/tp13.pdf [https://perma.cc/jp2b-7yy] [hereinafter tox. profile for lead]; see also u.s. dep’t of health & hum. ser., toxicological profile for arsenic vi (aug. 2007), https://www.atsdr.cdc.gov/toxprofiles/tp2.pdf [https://perma.cc/yva45va7] [hereinafter tox. profile for arsenic]. https://perma.cc/yva4 https://www.atsdr.cdc.gov/toxprofiles/tp2.pdf https://perma.cc/jp2b-7yy https://www.atsdr.cdc.gov/toxprofiles/tp13.pdf https://perma.cc/3pp9-cpuq https://semspub.epa.gov/work/05/929439.pdf https://perma.cc/k7qt-ba92 https://epa.gov/environmentaljustice https://www 2024] a crisis set to repeat itself 455 housing continues to be a major source of childhood lead poisoning;122 however, this danger is well publicized and addressed by numerous laws and regulations. 123 generally, the largest source of lead found in soil arises through its settling out of the atmosphere, but industry also contributes to adding to lead in soil.124 because of properties that allow lead to absorb strongly into soils as well as its resistance to degradation, historic sources of lead soil contamination are and will continue to be a source of lead exposure. 125 exposure to lead can cause a lasting loss of neurological functions, not limited to a reduction in cognitive functioning, but also altering behavior and mood, and motor and sensory functions. 126 this concern is elevated for children, and exposure can begin prenatally and adversely affect development. 127 blood lead concentration (pbb) levels at very low levels, such as beyond 5 micrograms per deciliter, can lead to adverse effects in many organ systems. 128 even so, the cdc has found that no lead blood level is safe for children. 129 arsenic has been found in at least 1,149 of the 1,684 current or former most serious waste sites in the nation and it is possible that the number of sites at which arsenic is found may increase in the future as more sites are evaluated. 130 when arsenic at hazardous waste sites is not disposed of properly, one can be exposed to it in the surrounding water, air, or soil. 131 children are at an increased risk of exposure through eating small amounts of soil. 132 many social factors contribute to health outcomes, such as location. 133 one study has found significant differences in life expectancy between census tracts without superfund sites within their boundary and neighboring tracts that contain a superfund site.134 in fact, the negative adverse impact on life expectancy could be up to five times higher for those who live in tracts in the lower 10% percentile income and contain a superfund site. 135 additionally, racial minority groups and low-income communities have been shown to have ————————————————————————————— 122. tox. profile for lead, supra note 121, at 1. 123. lead-based paint poisoning prevention act: pub. l. no. 91-695, 84 stat. 2078 (1971) (banning the use of lead-based paint in all residential projects). 124. tox. profile for lead, supra note 121, at 1-2. 125. id. 126. id. at 5. 127. id. at 4. 128. id. at 3. 129. id. 130. tox. profile for arsenic, supra note 121, at 1. 131. id. at 3. 132. id. at 4. 133. paula braveman & susan egerter, overcoming obstacles to health, rwjf comm’n to build a healthier america 1, 12 (feb. 2008), http://www.commissiononhealth.org/ pdf/obstaclestohealth-report.pdf [https://perma.cc/tr4v-fslp]. 134. amin kiaghadi et al., the presence of superfund sites as a determinant of life expectancy in the united states, nature comm. 1 (apr. 13, 2021), https://www.nature.com/ articles/s41467-021-22249-2 [https://perma.cc/r28k-n5yk]. 135. id. at 4 (stating that “[s]uch an increase in the severity of the harmful effects in tracts with more sociodemographic disadvantages is consistent with findings from other studies”). https://perma.cc/r28k-n5yk https://www.nature.com https://perma.cc/tr4v-fslp http://www.commissiononhealth.org indiana health law review [vol. 21:441 456 poorer health outcomes than others. 136 these groups bear a disproportionate share of environmental exposures and related illnesses. 137 studies and researchers have found that the lead levels in older, poorer neighborhoods often exceed safe levels, which can harm children and their development. 138 thus, it is essential that tools to identify and address contamination, as well as a system that mandates checking for contamination in housing projects, are in put into place. iii. analysis a. limited options in the face of future crises the wchc story and complex history shows for decades how hud and the epa struggled to respond to, and then right the wrongs of, the lead and arsenic contamination at the complex. without action, it is probable that residents living in other public housing will face similar contamination. as noted earlier, residents have already asserted claims premised on fear that health conditions will arise. 139 yet, residents will need to overcome multiple barriers to prevail on their claims. hud created the crisis by allowing the echa to construct public housing on a contaminated site and then failing to address the problem for decades. thus, instead of relying on courts to be compensated for their suffering, hud should be obligated to make residents whole and stop similar crises from repeating. residents of the wchc have not only been harmed, but the situation at the wchc is likely to repeat across the nation. in 2020, the shriver center on poverty law found that “70% of all superfund sites are located within one mile of hud-assisted housing developments.”140 however, this finding does not include federal housing programs not administered by hud or hazardous sites ————————————————————————————— 136. manuel pastor & rachel morello-frosch, gaps matter: environmental, health, & social equity, generations: j. am. soc’y on aging 28 (2018), https://www.jstor. org/stable/26556357 [https://perma.cc/muc5-bbux]; see also rachel morello-frosh et al., understanding the cumulative impacts of inequalities in environmental health: implications for policy, health aff. 879 (may 2011), https://pubmed.ncbi.nlm.nih.gov/21555471/ [https:// perma.cc/x78y-25eu]. 137. devon payne-sturges & gilbert c. gee, national environmental health measures for minority & low-income populations: tracking social disparities in environmental health, env’t rsch. 154, 154 (2006), https://pubmed.ncbi.nlm.nih.gov/16875687/ [https://perma.cc/9t4fe2yf]. 138. gabriel m. filippelli & mark a. laidlaw, the elephant in the playground: confronting lead-contaminated soils as an important source of lead burdens to urban populations, persp. in biology & med. 31 (2010), https://pubmed.ncbi.nlm.nih.gov/20173294/ [https://perma.cc/ e6ub-7hya]; see also c. marjorie aelion et al., associations between soil lead concentrations and populations by race/ethnicity & income-to-poverty ratio in urban and rural areas, env’t geochem health 1 (feb. 2013), https://pubmed.ncbi.nlm.nih.gov/22752852/ [https://perma. cc/k6cj-fv7b]. 139. mabry v. city of e. chi., 2021 wl 5141371. 140. coffey et al., supra note 6, at 11. https://perma https://pubmed.ncbi.nlm.nih.gov/22752852 https://perma.cc https://pubmed.ncbi.nlm.nih.gov/20173294 https://perma.cc/9t4f https://pubmed.ncbi.nlm.nih.gov/16875687 https://pubmed.ncbi.nlm.nih.gov/21555471 https://perma.cc/muc5-bbux https://www.jstor 2024] a crisis set to repeat itself 457 not on the npl. 141 the epa and hud estimate that the section 8 housing developments located within one mile of these hazardous waste sites are home to approximately 77,000 families. 142 furthermore, the lead and arsenic contamination faced by the wchc residents is not the only type of contamination that can plague a superfund site and risk the health of those who live near them. as required by the 1986 amendments to cercla, the atsdr has established a list recording and ranking at least 100 of the most hazardous substances currently present in at least one superfund site on the npl. 143 every two years, atsdr updates this list, now known as substance priority list. 144 each substance is ranked by its toxicity, the number of times it’s been found at a npl site, and the likelihood of exposure. 145 as of 2019, arsenic was ranked first, followed by lead. 146 despite only being required to list 100 substances, atsdr has listed 275 total substances that are of concern.147 tens of thousands of families live in public housing developments located within one mile of sites that can contain a wide array of toxic chemicals. 148 thus, it is unfortunate and likely that the wchc’s residents will not be the last to be exposed and impacted by the negative environmental health impacts linked to these sites. in indiana alone, about half of the fifty-three sites that have been on the npl since it was first published in 1980 are within two miles or less of hud-funded public housing.149 wchc residents may seek to recover costs associated with relocating, emotional distress, or for future medical monitoring and health impacts, but so too may other public housing residents if the wchc’s story repeats itself. the ability of residents to be made whole is limited legally. future residents of public housing that find they’ve been exposed need to consider the following hurdles to recovery. as one scholar notes, bringing independent causes of action, such as those grounded in tort-law, are cost-prohibitive and may require extensive law firm resources—limiting the firms that would be open to taking ————————————————————————————— 141. id. 142. id. 143. 42 u.s.c. § 9604 (2022). 144. atsdr’s substance priority list, atsdr agency for toxic substances & disease registry (jan. 17, 2020), https://www.atsdr.cdc.gov/spl/ [https://perma.cc/9q29-6u8j]; see also 10 steps to making an astdr toxprofile, atsdr agency for toxic substances & disease registry (nov. 12, 2019), https://www.atsdr.cdc.gov/toxprofiles/toxprofile_infographic.html [https://perma.cc/7hy7-45cr]. 145. 42 u.s.c. § 9604; see also 10 steps to making an astdr toxprofile, supra note 144. 146. atsdr’s substance priority list, supra note 144. 147. id. 148. coffey et al., supra note 6, at 2. 149. enrique saenz, decades of “missed opportunities” exposed multiple generations of east chicago residents to lead contamination, federal report finds, ind. env’t rep. (mar. 21, 2021), https://www.indianaenvironmentalreporter.org/posts/decades-of-missed-opportunitiesexposed-multiple-generations-of-east-chicago-residents-to-lead-contamination-federal-reportfinds [https://perma.cc/urw9-hde2]. https://perma.cc/urw9-hde2 https://www.indianaenvironmentalreporter.org/posts/decades-of-missed-opportunities https://perma.cc/7hy7-45cr https://www.atsdr.cdc.gov/toxprofiles/toxprofile_infographic.html https://perma.cc/9q29-6u8j https://www.atsdr.cdc.gov/spl indiana health law review [vol. 21:441 458 such cases. 150 in addition, a running statute of limitations and issues with latency between exposure and the onset of disease present additional barriers to recovery. 151 many, though not all, of the industrial polluters are no longer solvent or in operation, but may be pursued via the legal theory of successor in interest. 152 to recover from the federal or state government for their roles in the catastrophe, immunity presents another barrier to overcome. 153 and while the state of indiana, idem, and the epa, have been able to recover the costs of cleanup through cercla imposed strict-liability, 154 cercla does not allow funds to go towards compensating residents for moving or future health impacts.155 given the various limitations associated with civil litigation actions, such as those above as well as issues with latency, lapse of time, and proving causation, this note will focus on the regulatory options to preventing and solving environmental contamination facing residents of public housing. however, this is not to say that suing is impossible; residents of the wchc have overcome some of these hurdles to present their claims. 156 the outcome of the wchc-associated litigation could forecast the likelihood of recovery for other public housing residents put in a similar situation in the future. in state and federal courts, residents of the wchc have brought a variety of claims including but not limited to negligence, nuisance, trespass, intentional and negligent infliction of emotional distress, fraudulent concealment, breach of contract and implied warranty, as well as violations 14th amendment due process and of various statutes. 157 industrial defendants, such as atlantic richfield and dupont, have met these allegations with motions to dismiss. 158 thus far, plaintiffs’ claims against former industrial owners and operators of facilities at the wchc site for nuisance have been dismissed on multiple grounds.159 nevertheless, some of the residents’ claims may succeed against other parties, such as the echa and its director or the city of east ————————————————————————————— 150. hannah reed, indiana’s public health is in jeopardy: lessons to learn from toxic chemical contamination in east chicago, 15 ind. health l. rev. 109, 133 (2018). 151. id.; see also ind. code § 34-11-2-7 (2022). 152. reed, supra note 150, at 129. 153. id. at 126-128. 154. consent decree at 1, u.s. v. atl. richfield co. & e. i. dupont de nemours and co. (n.d. ind 2014) (no. 2:14-cv-312), https://semspub.epa.gov/work/05/919701.pdf [https://perma. cc/8w54-pbpz]. 155. 42 u.s.c. § 9611; see also paul j. lioy & thomas burke, superfund: is it safe to go home?, 20(2) j. exposure sci. & env’t epidemiology 113, 114 (2010). 156. rolan v. atl. richfield co., no. 1:16-cv-357-tls, 2017 wl 3191791, at 12 (n.d. ind. july 26, 2017). 157. mabry v. city of e. chi., 2021 wl 5141371.; see also adams v. atl. richfield co., no. 2:18-cv-375-jvb-jpk, 2021 wl 4819608, at 3 (n.d. ind. oct. 15, 2021). 158. mabry v. city of e. chi., 2021 wl 5141371.; see also adams v. atl. richfield co., 2021 wl 4819608, at 1. 159. rolan v. atl. richfield co., supra note 156, at 15 (stating that plaintiffs have failed to state a claim for nuisance because a “later purchaser of property cannot sue a prior owner of that same property for nuisance, as the latter owes no duty to the former” and that the contamination was not ongoing). https://perma https://semspub.epa.gov/work/05/919701.pdf 2024] a crisis set to repeat itself 459 chicago and its mayor. because this litigation is ongoing, the outcome will not be speculated upon in this note. rather, since these proceedings are ongoing and recovery is not ensured, this note will look to regulatory options that can promote the discovery of environmental contamination at public housing projects and options to provide residents more certain relief with fewer barriers. this is especially important given the potential for the wchc’s situation to arise again at other housing complexes. today the dangers of lead and arsenic are now well known and have been of high concern since the first substance priority list was published in 1987. 160 although unknown at the time the echa built the wchc, today land use history and elevated blood lead levels are indicative of chemical contamination. in the situation of the wchc, there were reports with data contrary to their conclusions, missed opportunities by hud to perform environmental assessments, and years of additional testing and waiting for data to be fully assessed while residents were being exposed. while hud should certainly partner with the epa and use its data, delaying action when there are other indicators of contamination, only furthers slow agency response. measures must be taken to prevent contamination from going undiscovered, undisclosed, and unremedied for such long periods of time. these measures must include updating hud regulation to ensure environmental reviews are performed proactively and with proper oversite, as well as expanding testing to cover a wider array of hazardous substances and surface types. in addition, regulation must provide recourse to residents if they face health conditions from being exposed at sites that were not remedied quickly and competently. b. solution one: safeguards to prevent a similar crisis the wchc’s story illustrates how both hud and the epa, which are responsible for keeping communities safe, 161 had multiple opportunities to discover and warn residents of the contamination at the complex as early as 1994. the failure of hud to provide adequate oversight resulted in wchc residents living in unsafe conditions for decades and the lead poisoning of children. 162 since the crisis at the wchc, both agencies have been working to close various gaps to prevent a similar crisis in the future, but they need to do more. while this section will provide an overview of those actions, it will also examine why these actions are insufficient and propose additional ways to protect public housing residents who live near superfund sites. following the relocation of wchc residents, hud promulgated a final rule ————————————————————————————— 160. notice of first priority list of hazardous substances that will be the subject of toxicological profiles, 52 fed. reg. 74, 12866, 12869 (apr. 17, 1987) (listing lead and arsenic within the highest priority group, “priority group 1”). 161. brooks & mellard, supra note 29, at 14. 162. off. of inspector gen., supra note 3, at 13. indiana health law review [vol. 21:441 460 in 2017 aligning its regulatory definition of elevated blood lead levels in children under six years old with the cdc’s determination that levels beyond 5 μg/dl are dangerous. 163 prior to updating this regulation, housing providers were not required to intervene unless the child had elevated blood levels four times higher than the cdc’s intervention level. 164 the final rule has also established more comprehensive testing and communication procedures under the lead safe housing rule (lshr), 165 and clarifies each parties’ responsibility. 166 now once this much lower-threshold blood level is detected in a child who lives in public housing, the pha must notify the public health department, various offices within hud, and all other residents if the property has multiple units. 167 additionally, an environmental investigation which includes testing “bare soil,” must be performed within fifteen days. 168 while the final rule amends hud’s lead based-paint regulations to address and, in the future, prevent some of the issues that occurred at the wchc, it could go farther to protect residents. first, “bare soil” only includes soil or sand not covered by grass or other types of ground cover. 169 the lion’s share of environmental contamination comes from former industry, and many toxins, as particulate matter, settle out of the air onto surfaces. given that children are likely to play on grassy surfaces, a variety of outdoor surfaces, as well as “bare soil” should be tested. second, an environmental investigation and communication is triggered only for lead, not other hazardous substances. certainly, the lshr is an important statute providing residents of all federally ownedand assisted-housing protection against lead. 170 the statute was originally designed to focus on leadbased paint but was amended by title x of the housing and community development act of 1992 to include lead-contaminated dust and soil. 171 while the lshr’s scope encompasses only lead, parallel statutes could be passed using its regulatory scheme to expand resident’s protection to other types of environmental contaminants. one place to start would be with the other ————————————————————————————— 163. requirements for notification, evaluation and reduction of lead-based paint hazards in federally owned residential property and housing, 82 fed. reg. 4151, 4152 (jan. 13, 2017) (codified at 24 c.f.r. 35). 164. walz & coffey, supra note 26, at 9, 10; see also off. of inspector gen., supra note 3, at 13. 165. requirements for notification, evaluation and reduction of lead-based paint hazards in federally owned residential property and housing, supra note 163, at 4152-54. 166. id. at 4156-72. 167. id. at 4170. 168. 24 c.f.r. §§ 35.730, 35.1335 (2022). 169. 24 c.f.r. § 35.110 (2022). 170. lead-safe housing rule requirements, u.s. dep’t of hous. & urb. dev., https:// www.hud.gov/program_offices/healthy_homes/enforcement/lshr_summary [https://perma.cc/z6 pq-3ebj] (last visited nov. 20, 2022). 171. an overview of what five federal agencies are currently doing to help make housing lead-safe for children: hearing before the subcomm. on hous. and transp. of the comm. on banking, hous., and urb. aff., 107th cong. 2 (2002) (statement of jack reed, senator) [hereinafter hearing]. https://perma.cc/z6 https://www.hud.gov/program_offices/healthy_homes/enforcement/lshr_summary 2024] a crisis set to repeat itself 461 substances at the top of the atsdr’s substance priority list since these substances are already ranked by their prevalence and threat to human health. 172 additionally these sister statutes could be narrowed to apply only to section 8 housing, and further to hud-assisted housing developments located within a mile of any site on the npl. third, while strengthening and clarifying testing and communication procedures is undoubtedly needed, it is only a response mechanism once elevated blood levels have already been detected. 173 given that an estimated one thousand public housing projects are within one mile of a superfund site, 174 phas should be taking steps to check these properties’ soil for environmental toxins, rather than responding only once elevated blood levels are detected. hud has relied on the epa to identify contaminated properties and does not have its own strategy to research and review potential contaminated properties. 175 furthermore the environmental review process, which would uncover contamination and trigger remediation or abatement, is not being performed by phas proactively. under hud’s regulations, phas are usually the “responsible entities” that must perform environmental reviews of multifamily housing to obtain hud approval of a project or funding. 176 phas should be performing environmental assessments which would unveil some contamination posing health risks under nepa. 177 under nepa, federal agencies are required to assess the environmental effects of proposed “major federal actions.”178 since a “major federal action” includes projects entirely or partly financed, assisted, regulated, or approved by federal agencies, the construction or financing of a public housing project by hud qualifies as a “major federal action” and triggers nepa.179 under nepa, before action is taken, federal agencies or the agency carrying out the federal action as well as cooperating agencies, 180 must explore and document alternative approaches and describe any potential environmental effects of each alternative.181 they must also involve the public through a scoping process and inviting comments on their assessment to increase public awareness and involvement. 182 the environmental effects to be assessed under nepa are broad,183 including not only how construction of a project might impact the ————————————————————————————— 172. atsdr’s substance priority list, supra note 144. 173. hearing, supra note 171. 174. coffey et al., supra note 6, at 11. 175. off. of inspector gen., supra note 3, at 16. 176. 24 c.f.r. §§ 58.1, 983.58 (2023). 177. 42 u.s.c. § 4332(2)(c)(i) (2022). 178. id. 179. 42 c.f.r. § 1508 (2023). 180. what is the national environmental policy act?, epa u.s. env’t. prot. agency (nov. 16, 2021), https://www.epa.gov/nepa/what-national-environmental-policy-act [https://perma.cc/ t9ze-92h3]. 181. 40 c.f.r. § 1502 (2023). 182. 40 c.f.r. §§ 1501.7, 1503 (2023). 183. 40 c.f.r. §1508(b) (2023). https://perma.cc https://www.epa.gov/nepa/what-national-environmental-policy-act indiana health law review [vol. 21:441 462 environment, but also in the context of hud-assisted projects, how the environment can affect the project and its residents. 184 in passing nepa, congress asserted that “each person should enjoy a healthful environment,” yet the act does not require agencies to choose a less environmentally impactful course of action after completing their assessment and receiving feedback from the public. 185 still controlling supreme court decisions held that nepa “does not mandate particular results, but simply prescribes the necessary process” to be followed. 186 so, while nepa generates agency transparency and promotes public engagement, an agency is not mandated to take a particular action in accordance with the results. thus, while hud would likely discover contamination through a nepa assessment, it could still construct housing on that site. of course, this decision would be unlikely not only because public involvement via nepa would promote outcry, but also because regulation governing hud requires that “all property proposed for use in hud programs be free of hazardous materials, contamination, toxic chemicals and gases, and radioactive substances.”187 this same regulation specifically requires an environmental review by hud to ensure compliance with nepa as well as other related laws and authorities. 188 therefore, hud has a responsibility to “ensure that state and local governments, as well as local housing authorities, comply with environmental reviews so potential contaminants that could endanger residents’ health are addressed.”189 hud’s compliance with nepa has one large caveat. since nepa was not passed until 1970, this means many hud-funded properties built before then, like the wchc, likely never received an initial environmental review. the 1989 american housing survey found that up to 61% of public housing units were built before 1970. 190 while some of this housing may have since been shut down, this still leaves much of public housing vulnerable. additionally, before 1996, environmental reviews were completed inconsistently. 191 both the epa and hud have been working together to determine which properties are within one mile of a superfund site on which “human exposure was not under control ————————————————————————————— 184. orientation to environmental reviews, hud exch., https://www.hudexchange.info/ programs/environmental-review/orientation-to-environmental-reviews/#overview [https://perma. cc/a5ak-skcp] (last visited nov. 20, 2022). 185. 42 u.s.c. § 4331 (2022). 186. robertson v. methow valley citizens council, 490 u.s. 332, 354 (1989); see also strycker’s bay neighborhood council, inc. v. karlen, 444 u.s. 223, 227-28 (1980). 187. 24 c.f.r. § 50 (2022). 188. 24 c.f.r. § 50 (2022); 24 c.f.r. § 58 (2022). 189. tracy jan, internal report cites hud for lead poisoning in east chicago, ind., children. more could be at risk., the wash. post (feb. 17, 2021, 6:00 am), https://www. washingtonpost.com/business/2021/02/17/hud-toxic-superfund/ [https://perma.cc/bn28-hm cm]. 190. public housing: image versus facts, u.s. hous. mkt. conditions (may 1995), https://www.huduser.gov/periodicals/ushmc/1stqtr95.txt [https://perma.cc/x7rd-aewm]. 191. off. of inspector gen., supra note 3, at 17. https://perma.cc/x7rd-aewm https://www.huduser.gov/periodicals/ushmc/1stqtr95.txt https://perma.cc/bn28-hm https://washingtonpost.com/business/2021/02/17/hud-toxic-superfund https://www https://perma https://www.hudexchange.info 2024] a crisis set to repeat itself 463 or there was not enough information to determine human exposure status.”192 in february 2020, this list included 2,528 public housing properties and 217 multifamily section 8 project-based rental assistance properties, 193 yet neither hud nor the inspector general’s office have released the list of properties. 194 this list not only needs to be released so residents may be warned of potential contamination, but environmental assessments need to be conducted to confirm contamination, initiate the remediation or abatement process, and allow residents support in relocating. hud has the ability and procedures to guide it in conducting environmental reviews, however, there is nothing to incentivize hud to perform environmental assessments retroactively on pre1970 properties or on other properties that have fallen through the cracks. by completing environmental reviews hud could be proactive in protecting its residents and through the procedural nepa process hud could involve and give notice to residents of their findings. currently hud defers to the epa on what action to take when public housing is located on an existing or proposed superfund site. 195 while hud should certainly consult with the epa, it should not wait for the epa to conduct testing before it acts. 196 hud policies and procedures state that hud should “must conduct its own due diligence at npl sites,”197 but the agency is not doing so. while environmental assessments are triggered by rehabilitation, this was not sufficient at the wchc to discover the contamination. as mentioned earlier, the echa’s failure to properly conduct environmental reviews allowed the echa to complete rehabilitation projects between 2003 and 2016 without discovering wchc’s contamination. 198 instead of waiting for these properties to be rehabilitated, change ownership, or change their land use, which would trigger an environmental assessment under nepa, the triggers of an environmental assessment should be adjusted. to add to these triggers, an environmental assessment should be done by phas a multi-family housing project it oversees is within one mile of a superfund site. under part 58, hud intends to check that phas are conducting their environmental reviews correctly every three years. 199 due to lack of time hud interviewees have said that “only very cursory review is ever done of the environmental issues.”200 to promote review by hud on a regular basis, ————————————————————————————— 192. id. at 16. 193. id. 194. jan, supra note 189. 195. dep’t of hous. & urb. dev., omb no. 2502-0541, env’t rev. & requirements 11, 9-23-24 (mar. 19, 2021), https://www.hud.gov/sites/dfiles/ochco/documents/4430ghsgg. pdf [https://perma.cc/2mje-hers]. 196. id. at 9-23-24. 197. id. 198. off. of inspector gen., supra note 3, at 11-13. 199. study of hud’s site contamination policies, huduser.gov es-1, 2-32-33 (june 20, 2003), https://www.huduser.gov/publications/pdf/hudsitecontamination.pdf [https://perma. cc/6534-h465] (prepared for u.s. department of housing and urban development). 200. id. https://perma https://www.huduser.gov/publications/pdf/hudsitecontamination.pdf https://huduser.gov https://perma.cc/2mje-hers https://www.hud.gov/sites/dfiles/ochco/documents/4430ghsgg indiana health law review [vol. 21:441 464 environmental assessments for housing projects within one mile of a superfund site should be an included aspect of the pha’s annual plan. annual plans are documents containing a statement of housing needs, financial resources, operation and management rules and standards, and the pha’s eligibility, selection, and admissions policies.201 it also includes other information about discretionary policies, as well as non-discretionary requirements. 202 this plan must be consistent with the pha’s overarching goals, missions, and objectives and provide grievance procedures available to residents and applicants. 203 in addition, public hearings and an opportunity to comment on the plan must be provided to residents. 204 a section detailing the findings of each environmental assessment performed at each housing complex within one mile of a superfund site should be added to 24 cfr § 903.7, which sets of the information which much be provided in an annual plan. 205 since the annual plan requirement was one of congress’s ways of holding pha accountable, the addition of information about environmental contamination would only further this accountability. requiring an environmental review’s findings in the annual plan would make phas’ capital funding dependent on conducting these. 206 this would create additional incentive for pha to comply and also give residents direct notice of any contamination.207 in addition, hud should be held responsible for conducting environmental reviews when it fails to properly oversee or withhold funds when a pha has not conducted the review properly or at all. as with other agencies who provide a public service, residents of public housing within one mile of a superfund site should also have a system to appeal to hud if the pha has not conducted an environmental assessment or shared the results with residents in their annual plan. this would encourage agency action and give residents an additional recourse when hud does not fulfil its charge that all properties be free of hazardous materials and contamination. 208 while the 2017 proposed rule by hud established more comprehensive testing and communication procedures under the lshr, it also requires that phas must abate “lead-based paint hazards.”209 this includes not just leadbased paint and dust, but the “removal or permanent covering of soil-lead ————————————————————————————— 201. 24 c.f.r. § 903.7 (2023). 202. id. 203. id. 204. 24 cfr § 903.17 205. 24 cfr § 903.7.. 206. dep’t of hous. & urb. dev., public housing agency (pha) plan desk guide 1, 12 (sept. 20, 2001), https://www.hud.gov/sites/documents/doc_8904.pdf [https://perma.cc/ ps8a-numb]. 207. id. at 1-2. 208. 24 cfr § 58.5 (2023). 209. requirements for notification, evaluation and reduction of lead-based paint hazards in federally owned residential property and housing, 82 fed. reg. at 4170 (feb. 13, 2017) (to be codified at 24 c.f.r pt.35) https://perma.cc https://www.hud.gov/sites/documents/doc_8904.pdf 2024] a crisis set to repeat itself 465 hazards.”210 to hold the pha accountable and ensure remediation or abatement is performed, compliance with these updated requirements and the rest of the lshr is included as part of the capital fund program regulations. 211 “[phas] that are not compliant with the lshr may be subject to sanctions including withholding, reducing, or terminating capital fund or operating fund assistance.”212 hud must begin holding phas accountable and subjecting phas to sanctions when they are noncompliant. as one scholar has suggested, hud grant and contract documents should also specify explicit amounts that will be withheld in the event lshr requirements are not satisfied. 213 additionally hud should ensure phas comply with the quarterly data collection and record keeping requirements, 214 by also making this information a necessary requirement of each pha’s annual plan. any failure to comply should result in a fine, which could then be used to create a fund, proposed below, to compensate residents for their suffering and any health conditions that arise from exposure. c. solution two: developing a recourse for harmed residents even if there are sufficient safeguards put in place to prevent environmental contamination from continuing to go unnoticed and unaddressed, systems need to be developed to provide recourse to injured residents. wchc residents deserve compensation for their suffering, having to relocate, and to help pay future medical expenses; however, there should be an option other than litigation. in the likely event additional contamination of public housing is uncovered at other complexes, those residents will also need an alternative option. while some argue that hud’s efforts to relocate affected residents was insufficient, the white house council on environmental quality has recommended that hud should establish a voluntary relocation program for residents whose housing was built on toxic sites. 215 president biden’s 2023 budget request sought up to ten million dollars to fund a pilot program which would, in part, include this voluntary relocation program. 216 since there are no proposals focused on compensating residents for their suffering and any health conditions that arise from exposure, this note proposes a solution tailored to that unaddressed issue. ————————————————————————————— 210. 24 c.f.r. § 35.110 (2022). 211. id. § 905.308. 212. id. § 905.804 (emphasis added). 213. emily a. benfer et al., duty to protect: enhancing the federal framework to prevent childhood lead poisoning and exposure to environmental harm, 18 yale j. health pol’y l. & ethics 1, 20 (2019). 214. 24 c.f.r. § 35.1225(g) (2022). 215. white house council on env’t quality, justice40 revisions 2, 132 (may 21, 2021), https://www.epa.gov/system/files/documents/2022-05/ceq_response_to_the_whej ac_may_2021_recommendations.pdf [https://perma.cc/29xp-5sbt]. 216. id. https://perma.cc/29xp-5sbt https://www.epa.gov/system/files/documents/2022-05/ceq_response_to_the_whej indiana health law review [vol. 21:441 466 once contamination of a property has been confirmed by an environmental review, the residents should also be supplied with options, apart from litigation, to remedy the situation. under hud’s 2017 final rule, residents must wait for the remediation or abatement process to be carried out and do not have any power in the process. 217 while residents will be notified of hazards, and interim controls may be put in place, they must be provided an option to receive more immediate assistance. senator durbin has proposed one solution, the lead-safe housing for kids act, which would require hud to relocate residents on an emergency basis without any wait, penalty, or lapse in assistance. 218 this proposal should be adopted because it will move many children out of danger. however, it only provides a remedy for those children exposed to lead and does not provide any assistance with residents’ health. as recommended earlier, sister statutes could be passed using the lshr regulatory scheme with senator’s durbin’s amendment to expand resident’s protection to other types of environmental contaminants. a much more comprehensive option would be for indiana, or the federal government, to pass a law that provides compensation to public housing residents—children and adults—exposed to hazardous chemicals due to their public housing’s proximity to a superfund site. since this note is the first to propose this solution, it thus looks to existing legislation that a compensation program could be modeled after. there are many existing no-fault compensation schemes for a variety of injured parties that are alternatives to the traditional tort system. 219 in the case of residents seeking compensation for their injuries and suffering caused by living in contaminated public housing, the most applicable legislation to model a fund after is the national childhood vaccine injury act of 1986 (ncvia). 220 the ncvia provides an alternative to the traditional tort system for compensating people injured by any vaccines administered on or after october 1, 1998, suffering injuries listed at 42 u.s.c.a. section 300aa-14. 221 under the act’s national vaccine injury compensation program, 222 a person who has suffered a vaccine-related illness or death need only submit a petition to the united states claims court alleging that the injury is vaccine related. 223 a special master will then issue a decision as to whether and how much ————————————————————————————— 217. benfer et al., supra note 213, at 21. 218. lead-safe housing for kids act, s.1860, 117th cong. (2021). 219. betsy j. grey, homeland security and federal relief: a proposal for a permanent compensation system for domestic terrorist victims, 9 n.y.u. j. legis. & pub. pol’y 663, 66768 (2005/2006); see also kathryn whetten-goldstein et al., compensation for birth-related injury no-fault programs compared with tort system, 153 archives pediatrics & adolescent med. 41, 41 (jan. 1999), https://jamanetwork.com/journals/jamapediatrics/ fullarticle/344865 [https://perma.cc/8bkh-kqyn]. 220. 42 u.s.c. § 300aa-1 (2022). 221. id. § 300aa-11. 222. id. § 300aa-10-19. 223. id. § 300aa-11. https://perma.cc/8bkh-kqyn https://jamanetwork.com/journals/jamapediatrics 2024] a crisis set to repeat itself 467 compensation is to be provided to the victim. 224 so long as the petitioner has demonstrated by a preponderance of the evidence that the injury or death is within the above timeframe and listed by the act, compensation shall be awarded. 225 thus, to receive compensation a victim does not need to demonstrate the vaccine manufacturer or administrator’s fault, a defect with the vaccine, or causation connecting the injury to a specific manufacturer or administrator under the ncvia. 226 a petitioner may also receive compensation by providing proof that a vaccine caused one’s condition or aggravated a previously existing condition. 227 compensation consists of expenses that will be incurred or have already resulted from the vaccine-related injury, and can include the costs of diagnosis and medical or other remedial or rehabilitative care. 228 compensation can also include attorney’s fees and awards for pain and suffering, limited to $250,000; punitive damages are prohibited. 229 if the person died from the vaccination, an award is limited to $250,000, plus attorney’s fees. 230 the ncvia is funded partially by appropriations from federal tax revenue and partially by an excise tax on each dose of a vaccine. 231 if a victim submits a petition but chooses not to proceed with their claim under ncvia and instead seeks to recover in court, their theories of liability in tort will be limited. if the injury or death was “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings” then a vaccine manufacturer shall not be held liable for such. 232 on the other hand if a victim agrees to accept compensation under ncvia they may not receive “a subsequent award in a civil trial.”233 since the ncvia’s inception, over 11,000 petitions have been filed. 234 while it may seem that the pool of who may collect from the ncvia is broad, the listed injuries and vaccines does not cover every injury and vaccine but ————————————————————————————— 224. id. § 300aa-12. 225. id. § 300aa-13. 226. lainie rutkow et al., balancing consumer and industry interests in public health: the national vaccine injury compensation program and its influence during the last two decades, 111 penn st. l. rev. 681, 684 (2007); see also shackil v. lederle labs., div. of am. cyanamid, co., 116 n.j. 155, 184 (1989). 227. 42 u.s.c. § 300aa-11 (2022). 228. 42 u.s. c. § 300aa-15 (including developmental evaluation, special education, vocational training and placement, counseling and therapy, and residential care, among other things). 229. id. 230. id. 231. id.; see also about the national vaccine injury compensation program, hrsa health res. & serv. admin. (apr. 2023), https://www.hrsa.gov/vaccine-compensation/about# :~:text=funded%20by%20a%20%24.,is%20prevented)%20of%20a%20vaccine [https://perma. cc/6kzj-hpx8]. 232. 42 u.s.c. § 300aa-22 (2022). 233. shackil v. lederle labs., div. of am. cyanamid, co., 116 n.j. 155, 185 (n.j. sup. ct. 1989). 234. rutkow et al., supra note 226, at 688. https://perma https://www.hrsa.gov/vaccine-compensation/about indiana health law review [vol. 21:441 468 rather mainly those routinely given to children and some adult vaccines. 235 in addition, the injury’s effects must have continued at least 6 months after the vaccine was administered or resulted in inpatient hospitalization or surgical intervention.236 however, the ncvia requires that all victims injured after 1988 must first prosecute a claim under the act before pursuing a separate cause of action under tort law. 237 thus, this may broaden the pool of petitioners slightly since it functions as a precursor to pursuing other tort actions. those harmed by exposure to contamination at public housing located within one mile of a superfund site should similarly be able to seek compensation under a no-fault scheme that would function similarly to ncvia. a person who has died or suffered an illness or condition arising from their exposure to contamination of their residence would file a petition that their claim is related to exposure in public housing with a court in indiana that is most akin to a court of claims. like the ncvia, exposure would have to occur after a certain date, which here might be the date of the report discovering which public housing complexes were located within a mile of a superfund site or [give date]. the list of injuries stemming from certain vaccines listed at 42 u.s.c. § 300aa-14, could be replaced with a list of substances on the atsdr’s substance priority list and the known conditions arising from exposure to those substances. this list could be narrowed to include only the top fifteen substances on the list and the resulting conditions or injuries that most commonly arise in children exposed to these, to mirror how the ncvia is tailored to focus on risks to children. if the petitioner demonstrates by a preponderance of the evidence that they lived within public housing within one mile of a superfund site and during their residence their injury or death is within the above timeframe and listed by the act, compensation should be awarded. like the ncvia, the injury’s effects must also continue for a certain amount of time from when the resident was exposed to the hazardous chemical or exposure resulted in inpatient hospitalization or surgical intervention. a petitioner could also be given the option to receive compensation by providing proof that exposure caused one’s condition, such as by showing elevated blood lead levels, or aggravated a previously existing condition. for ease of reference and lack of a better name, this proposal can be deemed the injured residents of contaminated public housing act (ircpha). the scheme could also be adopted nationally or by other states since it is estimated that approximately 77,000 families live within section 8 housing developments located within one mile a superfund site. 238 as mentioned above, residents have ————————————————————————————— 235. vaccine injury compensation programs, coll. of physicians of phila., https:// historyofvaccines.org/vaccines-101/ethical-issues-and-vaccines/vaccine-injury-compensationprograms [https://perma.cc/52vt-8d9b] (last visited apr. 5, 2023). 236. national vaccine injury compensation program, health & hum. serv. admin., https://www.in.gov/health/files/vicp.pdf [https://perma.cc/7tbu-uxw8] (last visited apr. 5, 2023). 237. 42 u.s.c. § 300aa-11 (2022). 238. coffey et al., supra note 6, at 11. https://perma.cc/7tbu-uxw8 https://www.in.gov/health/files/vicp.pdf https://perma.cc/52vt-8d9b https://historyofvaccines.org/vaccines-101/ethical-issues-and-vaccines/vaccine-injury-compensation 2024] a crisis set to repeat itself 469 numerous barriers to overcome to prevail in a tort action. like ncvia, this scheme should provide an alternative to the traditional tort system and wouldn’t make recovery contingent upon demonstrating that a provider of public housing knew it was contaminated or proving causation. to reduce litigation against providers of public housing and the industry that caused the contamination and prevent double recovery, a victim who accepts compensation should be precluded from receiving a subsequent award in a civil trial. however, the other parts of the ncvia that act as a required precursor to filing a tort action or limit victim’s ability to assert certain theories should not be retained since there already sufficient hurdles that make prevailing on a claim difficult for victims. as for compensation and funding of the indiana ircpha, these would again resemble the ncvia’s scheme. compensation for injured residents could include expenses that have already been incurred or have resulted from the resident’s exposure-related injury and should include the costs of diagnosis, medial, and other care. 239 although the children’s health insurance program (chip) provides some assistance to families in covering their children’s health care needs,240 compensation under the proposed act would also include compensation for developmental evaluation, special education, and therapy among other things which are particularly needed for children suffering from cognitive and learning disabilities due to lead exposure. also, like the ncvia, compensation could also include awards or pain and suffering and exclude awards for punitive damages. funding would not have to be equivalent of the “up to the eighty million dollars” which congress appropriated for the ncvia. 241 here the pool of potential injured individuals in indiana would be those living in public housing complexes within one mile or less of public housing and is thus much smaller than all individuals in the nation who might be harmed by a vaccine. this pool would widen if an ircpha were enacted by the federal government, rather than just the state of indiana. for an act applicable only to indiana, the indiana general assembly could appropriate some funds, just as congress did with the ncvia to “assure funding during the nascent stages of the act. . . .”242 the rest of the funding could come from fines on phas that do not properly conduct environmental reviews or comply with annual plan requirements. until hud begins enforcing compliance and fining phas, this may not be sufficient. generally, other scholars have also suggested levying a risk tax on the production of certain chemicals. 243 in this application, the chemicals taxed should be the top fifteen substances on the atsdr’s substance priority list. ————————————————————————————— 239. 42 u.s.c. § 300aa-15 (2022). 240. hoosier healthwise, ind. medicaid for members, https://www.in.gov/medicaid/ members/member-programs/hoosier-healthwise/ [https://perma.cc/g5eu-8fj8] (last visited apr. 5, 2023). 241. shackil v. lederle labs., div. of am. cyanamid, co., 116 n.j. 155,183 (n.j. sup. ct. 1989). 242. id. 243. reed, supra note 150, at 135. https://perma.cc/g5eu-8fj8 https://www.in.gov/medicaid indiana health law review [vol. 21:441 470 for example, in indiana, this would consist of a tax on manufacturers of lead or arsenic, which generally operate in the areas that most need public housing like east chicago, indiana. some may argue that adopting an entire compensation scheme would be overly complicated and that a simpler option would be for indiana courts to broaden liability and reduce barriers so that plaintiffs may more easily prevail on their claims and receive compensatory damages. in shackil v. lederle laboratories, div. of american cyanamid, co. the supreme court of new jersey found that broadening liability in order to provide compensation would not serve the goals of public policy. 244 in shackil, the primary plaintiff, after being administered the dpt vaccine as an infant suffered severe decreases in brain functioning.245 by the time of the suit, the plaintiff had difficulties proving a reasonable connection between the act or omission of the vaccine manufacturer and the damages. 246 this was due to “the extensive time that had elapsed between the inoculation and the lawsuit,”247 and while not the same as latency, lapse of time is another barrier facing many plaintiffs who bring tort claims. instead of expanding liability by allowing the plaintiff to shift to the defendant the burden of proof on the causation issue using various exceptions, the court found that the ncvia fulfilled the goal of providing satisfactory compensatory relief to injured plaintiffs. 248 to make litigation easier for plaintiffs to prevail, indiana courts could adopt similar exceptions as those mentioned in shackil, but this approach has not been adopted in indiana. 249 nor would it be the most tailored solution for providing residents harmed by living in contaminated public housing compensation. while the shackil opinion was confined solely to the context of vaccines, 250 that context is analogous to providing public housing. like how one societal goal supporting the public welfare is to encourage the use and development of needed drugs,251 another is to promote the availability of safe and affordable housing for low-income families. a goal of the ncvia was to provide compensation to plaintiffs “who would otherwise engage in protracted litigation against a vaccine manufacturer with the consequent risk of being denied recovery because of failure to prove the prima facie elements of a tort-law cause of action.”252 the proposed indiana ircpha would severe a similar goal. both acts would eliminate the “traditional elements of proof that often prove fatal to a tort-law claim” and thus, provide a remedy while also supporting, rather than detracting ————————————————————————————— 244. shackil, 116 n.j. at 158. 245. id. at 159. 246. id. at 163. 247. id. at 159. 248. id. at 158, 163. 249. city of gary v. smith & wesson, 801 n.e.2d 1222, 1245 (ind. 2003). 250. shackil, 116 n.j. at 191. 251. id. at 178. 252. id. at 184. 2024] a crisis set to repeat itself 471 from, public policy. 253 like the nvcia, an analogous act for indiana public housing residents makes a means of compensatory relief available to the plaintiff, and “although potentially smaller than a jury award,” compensation would be certain. 254 expanding exceptions for proving causation and fault in the tort context would thus impose more liability on the providers of public housing. while this may help hold hud and phas accountable, it may also make providing affordable and safe public housing more difficult. since the 1990’s budget reductions and the faircloth amendment have limited progress in the construction and repairs of public housing. 255 like the public policy of encouraging the development of necessary drugs, public policy also must encourage the development of safe and affordable public housing. the ncvia, in its adoption was intended to maintain an adequate number of vaccine manufacturers and prevent a vaccine shortage. 256 the website for rental assistance in indiana notes that “some phas have long waiting lists,”257 and while there are seventeen phas in indiana, less than half have public housing waitlists that can be applied to while all the others’ waitlists are closed. 258 as in shackil, the issue cannot be resolved “simply by expanding tort-law liability” since the nature of the problem is complex. 259 the goal here is not to completely insulate public housing providers from liability but acknowledge that imposing excessive liability would discourage a highly useful activity to the public welfare. 260 at the same time, providing compensatory relief to harmed individuals and families is desirable. 261 therefore, indiana should adopt the proposed no-fault compensation scheme, and thus balance the interests of harmed residents with that of the public welfare. like ncvia, the proposed indiana ircpha would allow awards to be granted to injured residents “quickly, easily, and with certainty and generosity.”262 ————————————————————————————— 253. id. 254. id. at 186. 255. jackson gandour, “we deserve to have a place to live” how us underfunding public housing harms rights in new york, new mexico, and beyond, hum. rts. watch (sept. 27, 2022), https://www.hrw.org/report/2022/09/27/we-deserve-have-place-live/how-us-underfund ing-public-housing-harms-rights-new [https://perma.cc/6z93-mk2h]. 256. see shackil, 116 n.j. at 184. 257. rental help: indiana, u.s. dep’t hous. & urb. dev., https://www.hud.gov/states/ indiana/renting [https://perma.cc/t238-nns3] (last visited apr. 5, 2023). 258. public housing agency websites: indiana, u.s. dep’t hous. & urb. dev., https:// www.hud.gov/states/indiana/renting/hawebsites [https://perma.cc/n96s-wcym] (last visited apr. 5, 2023). 259. shackil,116 n.j. at 186. 260. id. at 191. 261. id. at 181. 262. id. at 182. https://perma.cc/n96s-wcym https://www.hud.gov/states/indiana/renting/hawebsites https://perma.cc/t238-nns3 https://www.hud.gov/states https://perma.cc/6z93-mk2h https://www.hrw.org/report/2022/09/27/we-deserve-have-place-live/how-us-underfund indiana health law review [vol. 21:441 472 iv. conclusion research has shown that low-income minority populations shoulder a disproportionate share of environmental exposures and related illnesses. 263 the fact that 66% of hud users are racial minorities, 264 and an estimated 77,000 families live in public housing developments located within one mile of a hazardous waste sites, 265 supports this research. however, these statistics also indicate a clear opportunity for the hud to rectify its failures in providing these communities a safe and healthy environment. the story of the wchc is the result of an unfortunate combination in the lack of communication and coordination by the epa, hud, and the echa, as well as gaps in regulation and oversight that allowed environmental assessments to go unperformed. while there are some safeguards that were put in place after the wchc’s construction, these proved insufficient. as the office of the inspector general found in their report, until hud has a clear strategy to “review, research, and monitor” the public housing properties where human exposure to contamination from nearby superfund sites was not under control, “the longer residents will live on potentially contaminated land, prolonging their exposure.”266 thus, this note ultimately advocated for two solutions. first, hud’s regulations could be further strengthened to promote the discovery of contamination sooner, and second, indiana must adopt a no-fault compensation scheme to provide harmed residents recourse. if the two solutions are adopted in indiana this will have the potential to uncover contamination at many of the hud-funded public housing that are within two miles about half of state’s fifty-three superfund sites. 267 for residents, especially for those that are the most vulnerable such as children, this could reduce the time they are exposed to hazardous chemicals and kick start their process of moving into cleaner housing. if the indiana ircpha is enacted those harmed would also have a guaranteed source of compensation that could reimburse them for their pain and suffering and cover related health, rehabilitation, and other expenses. for children with elevated blood lead levels, this would mean additional support for them to access specialized educational programs, therapy, vocational training, and residential care, if needed. this note’s proposals would likely face multiple challenges. first, there may be push back from phas that do not want to perform environmental assessments, there could be a presumption of having to perform these and include the results in its annual plans if the public housing it oversees is within ————————————————————————————— 263. payne-sturges & gee, supra note 137, at 154. 264. public housing statistics, ipropertymanagement, https://ipropertymanagement. com/research/public-housing-statistics#:~:text=45%25%20of%20hud%2dassisted%20ind ividuals,housing%20assistance%20for%209.8%20years [https://perma.cc/22zm-b7qn] (may 9, 2022). 265. coffey et al., supra note 6, at 11. 266. off. of inspector gen., supra note 3, at 18. 267. saenz, supra note 149. https://perma.cc/22zm-b7qn https://ipropertymanagement 2024] a crisis set to repeat itself 473 one mile of a superfund site. phas could be allowed to overcome this presumption and attendant requirements by proving that contamination is under control and not at a level that poses a substantial risk to the most vulnerable residents’ health. in addition, indiana’s pha’s ranked second to last out of fifty states in “in winning just a fraction of the more than $354 million” in federal funding to support public housing that was distributed between phas nationally. 268 the indianapolis housing agency has failed to apply for “at least $4.4 million in annual federal funding.”269 if indiana phas made improving the grants for funding a priority, this money would support the phas in performing environmental reviews. second, there may also be push back by lawmakers when it comes to adopting the proposed compensation scheme. the wchc has not only shown that adopting such a program is needed, but with the high potential for the situation to repeat elsewhere in the state, lawmakers should be ready to address the outcry and possible lawsuits when it does occur. more importantly, funding is available. in 2022, indiana had $6.1 billion in reserves and $1.24 billion more than expected.270 this is more than enough to ensure that indiana can continue to provide essential services while also adding some to a compensation program until revenue from fines and a risk tax can support the scheme fully. 271 while indiana industry may push back against a risk tax, it could be set at a reasonable level and spread across many manufacturers and users of hazardous chemicals. in addition, industry most often operates in the overburdened communities that most need public housing and are part of the reason why public housing is often contaminated in the first place. as time progresses, the inclusion of environmental justice considerations in legislation and the prioritization of environmental justice issues in regulations is only growing. 272 to align with environmental justice priorities and prevent issues like the ones epitomized by the echc, affirmative steps must be taken now. however, hud’s failure to amend its regulations as proposed in this note, as well as the absence of this note’s compensatory scheme, leads only to the foregone conclusion that wchc residents will not be the last to be exposed and ————————————————————————————— 268. russ mcquaid, homeless funding failure tied to previous mayor’s grant request, cbs4 (may 8, 2016, 7:30 pm), https://cbs4indy.com/news/homeless-funding-failure-tied-to-previousmayors-grant-request/ [ https://perma.cc/j2s9-zzsa]. 269. ko lyn cheang, as indy housing agency faces financial crisis, residents suffer the brunt of its neglect., indystar (june 2, 2022, 2:20 pm), https://www.indystar.com/story/news/local/ marion-county/2022/06/02/indianapolis-housing-agency-bedbugs-apartment-conditionsresidents-neglect-property/9576197002/ [https://perma.cc/4shr-mlbx]. 270. kaitlin lange, state ends fiscal year with $6.1 billion in reserves as lawmakers mull taxpayer refund, indystar (july 15, 2022, 2:13 pm), https://www.indystar.com/story/news/ politics/2022/07/15/indiana-ends-fiscal-year-with-6-1-billion-in-reserves/65374284007/ [https:// perma.cc/rn3q-t54w]. 271. id. 272. environmental justice update, o’melveny (jan. 31, 2022), https://www. omm.com/resources/alerts-and-publications/alerts/environmental-justice-update-january-2022/ [https://perma.cc/xhv4-rexr]. https://perma.cc/xhv4-rexr https://omm.com/resources/alerts-and-publications/alerts/environmental-justice-update-january-2022 https://www https://www.indystar.com/story/news https://perma.cc/4shr-mlbx https://www.indystar.com/story/news/local https://perma.cc/j2s9-zzsa https://cbs4indy.com/news/homeless-funding-failure-tied-to-previous indiana health law review [vol. 21:441 474 impacted by the negative environmental health impacts linked to nearby superfund sites. in fact, it is unfortunate and likely that the wchc’s residents will not be the last to be exposed. therefore, the solutions proposed by the note are necessary and urgent. structure bookmarks risis et to epeat tselfmproving egulation ollowing the atastrophe of the est alumet ousing omplex health & justice: how misconduct commissions revived covid protocols through judicial discipline marcus alan mcghee* i. nature of the problem the model code of judicial conduct is a set of standards for the ethical conduct of judges.1 these rules are promulgated, not as an exhaustive guide, but as guidance to assist judges in maintaining the highest standard of judicial and personal conduct.2 when there are violations of these ethical norms, these rules also provide a basis for regulating judicial conduct through disciplinary agencies.3 this article seeks to answer the question of whether a judge’s impartiality can reasonably be questioned if they decide not to participate in or discourage healthcare directives articulated by the executive branch and other health care organizations during a global pandemic. this article posits that a judge demonstrates bias and violates their ethical responsibilities under the code of judicial conduct when they take personal actions that contravene lawfully established health protocols. part ii of this article introduces the problems courts faced when they had to shutter and reopen courtrooms during the coronavirus (“covid-19”) pandemic. part iii reviews the ways judges attempted to bypass, discourage the use of, or otherwise disparaged covid protocols and how judicial misconduct commissions disciplined those transgressions. part iv proposes tailored continued legal education programming that would assist judges in distinguishing between personal autonomy and their responsibilities under the code of judicial conduct. ii. legal status quo during the early months of 2020, court systems across the nation were challenged with closing their judicial system to stop the spread of the coronavirus.4 this was an arduous and complex task given constitutional * ethics attorney; ll.m. candidate, 2022, indiana university robert h. mckinney school of law; j.d., 2016, indiana university robert h. mckinney school of law; m.p.a., 2012, northern kentucky university; b.a., 2010, criminal justice, cum laude, northern kentucky university. 1. model code of jud. conduct, preamble, § 3 (2011). 2. id. 3. id. 4. see e.g. ind. exec. order no. 20-8, p. 6 (2020) [https://perma.cc/gzk7-452h]; in re: covid-19 pandemic emergency response, administrative order suspending all inperson court proceedings for the next thirty-days (mar. 13, 2020), https://www.ncsc.org/ _ _ data / assets/pdf_file/0014/19103/alabama-3-13-2020-cov-1 9 -order -f in a l. pdf [https://perma.cc/4a5v-vwxp]; in re response to the covid-19 pandemic (mar. 17, 2020), https://www.ncsc.org/__data/assets/pdf_file/0025/19681/arkansas-3-17-2020-supreme-court-ofarkansas-per-curiam-re-response-to-covid-19-pandemic.pdf [https://perma.cc/7gvb-x9ng]. 388 indiana health law review [vol. 19:387 provisions to keep courts open to the public.5 nevertheless, governors activated their emergency management powers by issuing executive orders and mandated isolation and quarantining.6 this had several negative side effects. first, criminal trials were continued, leaving prisoners to experience extended stays in detention facilities.7 second, court proceedings were delayed as judges, attorneys, and litigants attempted to get acclimated to video conferencing platforms.8 nevertheless, some jurisdictions halted foreclosures and evictions.9 this action prevented vulnerable populations from losing the one thing that—at the time—had the most notable impact on transmission of the virus, being able to retreat into the privacy of one’s home. additionally, some states participated in early release programs, allowing low-risk offenders to return home pending trial to decrease the likelihood of new arrestees spreading the virus in jail and among prison populations.10 similarly challenging was the task of reopening. staffing was inconsistent as agencies dealt with resignations and illness.11 on top of that, courts now needed to determine effective methodologies for reducing the transmission of a contagious virus. this meant attempting to process more cases with fewer people permitted in the building and even fewer employees to process the paperwork. to address these concerns, supreme courts activated emergency administrative rules to ease the burden.12 through resuming court operations plans courts advocated for the enforcement of mask mandates, social distancing, room capacity 5. see e.g., ind. const. art. 1 § 12. 6. see e.g., ind. code § 10-14-3 (2020); see also ind. exec. order 88 (2020), [https://perma.cc/gzk7-452h]. 7. melissa chan, 'i want this over.' for victims and the accused, justice is delayed as covid-19 snarls courts, time, https://time.com/5939482/covid-19-criminal-cases-backlog/ [https://perma.cc/mr8p-qrkq] (last updated feb. 23, 2021); see also jenni bergal, states halt jury trials again, leaving many defendants in jail, nat’l conf. state legislatures (dec. 8, 2020), https://www.ncsl.org/research/civil-and-criminal-justice/states-halt-jury-trials-again-leavingmany-defendants-in-jail-magazine2020.aspx [https://perma.cc/2x38-bfb8]. 8. steven lerner, virtual courtrooms prove to be both curse and blessing, law360 (jan. 8, 2021, 12:44 pm), https://www.law360.com/articles/1339460/virtual-courtrooms-prove-to-beboth-curse-and-blessing [https://perma.cc/4xum-azmc]. 9. see e.g., jeff weise, updated status of foreclosure and eviction proceedings with federal directives and state executive order (may 20, 2020), https://www.in. gov/courts/files/covid19-2020-0520-foreclosure-eviction.pdf. 10. see e.g., letter from eric holcomb, rodric bray, loretta rush, todd huston (apr. 3, 2020), https://www.in.gov/courts/files/covid19-2020-0403-release-assessment-local-effort.pdf [https://perma.cc/22rm-kep2]. 11. see e.g., matt markovick, king county courthouse staff quitting, blame safety issues at homeless camp, komonews (may 17, 2021), https://komonews.com/news/local/growinghomeless-camp-outside-courthouse-creating-safety-concerns-for-employees-residents [https://perma.cc/rwj4-2944]. 12. see e.g., ind. sup. ct. admin. r. 17. 2022] health & justice 389 restrictions, remote working schedules, and the liberal use of sick leave policies.13 unfortunately, even with these clearly articulated parameters, trial court judges across the nation failed to adhere to health measures.14 some judges required in-person appearances, failed to social distance and attended work while caring for those who had contracted the coronavirus.15 these actions are particularly puzzling given that the law—state issued executive orders and supreme court opinions—explicitly outlawed such practices. in doing so, they demonstrated a personal bias that they would impose their personal beliefs on others despite legal authority to the contrary. to prove these assertions, the following case studies are provided. the cases are divided into three separate sections. the first section discusses how a judge failed to comply with the law by not implementing proper health edicts and how that endangered the wellbeing of attorneys and defendants. the second section discusses how one trial court judge denied a party the opportunity to be heard, thereby denying the litigants procedural and substantive due process rights. finally, the third section describes how judges demonstrated improper demeanor when discussing covid protocols, which contributed to decreasing the public’s confidence in the integrity of the judiciary. iii. interstate review a. failure to comply with the law in in re disqualification of fleegle, judge mark fleegle of ohio’s muskingum county court of common pleas was disqualified from two criminal jury trials for failing to implement covid protocols.16 during december 2020, judge fleegle expressed concern that two cases would have to be dismissed for violating the defendant’s right to a speedy trial if they did not proceed to trial.17 to prevent this, the judge marshalled through the cases without regard to any health guidelines implemented since the start of the covid-19 pandemic.18 one defense attorney noticed. specifically, he observed the judge conducting hearings in person rather than by remote technology and that he did not mandate facial coverings.19 the attorney objected to the judge’s procedure, arguing judge fleegle risked trial participants’ health by violating the governor’s statewide mask order and ignoring recommendations from the chief justice.20 judge fleegle 13. see e.g., guidance from the resuming court operations task force, ind. sup. ct., h t tps://www.in.gov/courts/f iles/covid19-resuming-tr ial-court-operations-fall.pdf [https://perma.cc/7r4b-4am8] (last visited mar. 13, 2022). 14. see e.g., infra section ii. 15. id. 16. in re disqualification of fleegle, 161 ohio st. 3d 1263, 1267 (ohio 2020). 17. id. at 1266. 18. id. 19. id. 20. id. 390 indiana health law review [vol. 19:387 “dismissed the objection by stating that the recommendations were not mandatory and that his large courtroom allowed for social distancing.”21 the attorney insisted that the increasing number of covid cases in their county necessitated a strict compliance approach.22 furthermore, the attorney stated that due to his age he was at greater risk of having a severe reaction to contracting the virus.23 moreover, the attorney noted that his clients wanted to the trial continued because they feared their attorney would be preoccupied with the lack of covid protocols instead of focusing on the specifics of their case.24 judge fleegle insisted that the recommendations from the supreme court were not binding since they were not rules or orders.25 nevertheless, he decided that based on the increase in covid cases to require face masks.26 the defense attorney rebuked the judge’s efforts and filed for the judge to be disqualified.27 the attorney noted that the judge’s policy was not reduced to writing so no one knew that he had changed his stance, for example, on masks in the courtroom.28 when the supreme court reviewed the attorney’s request, they asked judge fleegle to provide a copy of his covid protocols.29 the judge responded that he had no written policy but that he had recently made the following changes: all persons in his courtroom will wear masks, except he will remove his mask when seated on the bench, witnesses will remove their masks when they testify, and attorneys may lower their masks to speak and be understood; social distancing will be followed; the courthouse staff will continue to screen and check the temperature of individuals entering the courthouse; and anyone uncomfortable with the requirements will be permitted to leave, including potential jurors.30 in finding that judge fleegle’s courtroom policies were wanting, the court removed him from the cases.31 the court supported their decision by emphasizing the increase in covid cases, the number of deaths, and the county’s decision to declare a public emergency, which ordered residents to limited activities and follow health orders.32 in their opinion, the court reasoned that “[w]ithout written procedures, no one [would] know what [was] expected of them 21. id. 22. id. 23. id. at 1263. 24. id. 25. id. 26. id. 27. id. 28. id. 29. id. at 1264. 30. id. 31. id. at 1267. 32. id. at 1265-67. 2022] health & justice 391 upon entering judge fleegle’s courtroom.”33 further, they noted that “unwritten (and unknown) policies cannot be effectively enforced.”34 additionally, they scolded judge fleegle and stated that “he should have recognized that other people take public-health recommendation very seriously and that the health concerns of attorneys and parties should be an important factor in deciding whether to proceed with jury trials . . . .”35 most notably though, the supreme court pointed out that judge fleegle “failed to sufficiently explain the urgency of going forward with the two jury trials . . . .”36 while judge fleegle attributed it to the speedy trial requirements, the court highlighted that the governor’s executive order tolled the speedy trial statute, and that in one of the cases the litigant even waived the requirement.37 while the disqualification motion did not explicitly result in judicial misconduct, the order from the supreme court can be seen as being analogous to a discipline proceeding. a review of the rules suggest judge fleegle violated rules 1.138 and 1.2,39 and possibly rule 2.4(b)40 of the model code of judicial conduct. rule 1.1 requires judges to comply with the law, including constitutional provisions, statutes, case law, executive orders, and supreme court rules and opinions.41 rule 1.2 requires judges to act at all times to promote public confidence in the integrity and impartiality of the judiciary.42 rule 2.4(b) requires judges to ensure that political and other outside factors do not influence how they behave in court.43 in examining his decision opposing the law requirements, a violation of rule 1.1 and 1.2 becomes clear. additionally, the concern of whether external influences (e.g., politics) impacted the judge’s ability to comply with the law takes center stage. while a judge’s personal choices and other political views may permissibly differ from the law, their behavior must always conform to the law.44 judge fleegle’s decision to deviate from mandates from the department of health, the governor, and the supreme court and implement his own procedure unnecessarily 33. id. at 1265. 34. id. 35. id. at 1266. 36. id. 37. id. 38. model code of jud. conduct r. 1.1 (2020) (“a judge shall comply with the law, including the code of judicial conduct.”). 39. model code of jud. conduct r. 1.2 (2020) (“a judge shall act at all times in a manner that promotes public confidence in the independence, integrity, and impartiality of the judiciary, and shall avoid impropriety and the appearance of impropriety.”). 40. model code of jud. conduct r. 2.4(b) (2020) (“a judge shall not permit family, social, political, financial, or other interests or relationships to influence the judge’s judicial conduct or judgment.”). 41. model code of jud. conduct r. 1.1. 42. model code of jud. conduct r. 1.2. 43. model code of jud. conduct r. 2.4(b). 44. model code of jud. conduct r. 1.1. 392 indiana health law review [vol. 19:387 endangered the health of those who entered the courthouse and their families.45 b. failure at ensuring the right to be heard in in re burchett, judge debra burchett of washington’s cowlitz county district court was disciplined for, amongst other things, denying a litigant’s right to appear virtually at a court hearing.46 the misconduct board received complaints “[i]n january and february 2020 concerning respondent’s handling of court proceedings, alleging [she] failed to conduct hearings in accordance with court rules and established case law[,] which protect criminal defendants' fundamental due process and constitutional rights.”47 during the investigation for the misconduct, commission learned of other transgressions by judge burchett.48 specifically, they learned that on february 26, 2021, judge burchett was concluding her afternoon docket when her clerk noticed that one person remained in the zoom waiting room.49 the clerk asked whether the person should be granted entry and in an exhausted tone, judge burchett said, “[i] just can’t.”50 the clerk looked to see who the person was to notify them that their court date would be continued to the next hearing.51 in doing so, the person’s name caught the clerk’s attention. the person had renamed themselves “help i couldn’t log in at 2pm.”52 the clerk immediately recalled that the judge had issued a bench warrant for a litigant who failed to appear at the 2:00 p.m. docket call.53 she notified the judge that it was likely the defendant who had failed to appear earlier, but the judge insisted on closing the docket for the day.54 as a result, the clerk notified the litigant that they would have to appear at the bench warrant docket scheduled for another day.55 in a public admonishment, the misconduct commission held that judge burchett had failed to conform to the ethical standards of her office. the board noted that “[b]y choosing not to hear from a person who seemed to be a litigant attempting to participate in a hearing via zoom, respondent abdicated her responsibility to ensure the right to be heard” in violation of rule 2.6(a)56 of the 45. see state v. lynum (in re fleegle), 163 n.e.3d 609 (ohio 2020) 46. in re the honorable debran burchett, wash. comm’n on jud. conduct, cjc# 9848-f-191 (2021), https://www.cjc.state.wa.us/materials/activity/public_actions/2021/9848final stip.pdf [https://perma.cc/mf6c-l3ak]. 47. id. at 1. 48. id. at 3. 49. id. 50. id. 51. id. 52. id. 53. id. 54. id. 55. id. 56. see e.g., model code of jud. conduct r. 2.6(a) (2020) (“a judge shall accord to every person who has a legal interest in a proceeding, or that person’s lawyer, the right to be heard 2022] health & justice 393 code of judicial conduct.57 the judge’s actions also had the potential to negatively impact the litigant’s future desire to use of zoom to attend court hearings. it would not be unreasonable for a litigant to believe that if their technology should fail them that they risk having a warrant issued for their arrest. this may encourage some to risk an in-person appearance, which could expose them to the coronavirus, all to have their day in court. c. failure to support pandemic protocols in in re connolly, judge patrick connolly of california’s los angeles county superior court was disciplined for improper demeanor toward two criminal defense attorneys during an arraignment.58 on march 20, 2020, the day after the governor announced the statewide stay-at-home order due to covid19, two defense attorneys—each representing one of the co-defendants— requested to appear telephonically.59 both stated they were concerned about having been exposed to the covid-19 virus and the possibility of spreading it at the courthouse.60 defense attorney #1 called judge connolly’s clerk to request permission to appear by telephone for the arraignment scheduled that afternoon.61 ultimately, the judge agreed and both attorneys appeared by phone.62 their clients were in custody and appeared in person.63 both attorneys proceeded through arraignment and at the end requested that their clients be release on their own recognizances, citing, among other reasons, health concerns outline in written documents.64 in each case, judge connolly trotted out his intransigence as if it were a virtue. each time one of the attorneys attempted to discuss the written evidence the judge would retort, “how am i going to see that letter, if you’re not in my courtroom?”65 when the attorneys attempted to reply to the judge, he would talk over them.66 the attorneys struggled to reassure the judge they were in possession of the necessary evidence.67 every time they discussed a document the judge would say, “which i cannot see, because you have not come to my courtroom.”68 when the attorneys according to law.”). 57. in re burchett, supra note 46, at 7. 58. in re connolly, cal. comm’n on jud. performance (2021), https://cjp.ca.gov/wpcontent/uploads/sites/40/2021/04/connolly_do_pub_adm_4-2-2021.pdf [https://perma.cc/2uhnuknc]. 59. id. at 2. 60. id. 61. id. 62. id. 63. id. 64. id. at 2-3. 65. id. 66. id. 67. id. 68. id. at 3. 394 indiana health law review [vol. 19:387 endeavored to reason with the judge one last time, he declined to listen to any future arguments and summarily set bail.69 after a complaint was filed with the misconduct board, judge connolly was called to answer for his behavior. “in judge connolly’s response to the preliminary investigation letter, he acknowledged that he ‘should not have demonstrated irritation or impatience with defense counsel’ and that he ‘spoke too sharply’ to them.”70 “the commission acknowledge[d] that the circumstances caused by the public health crisis were unusual and presented challenges,” but held, “that the initial lack of clarity about how to handle court proceedings during the public health crisis did not excuse or explain the judge’s mistreatment of the attorneys.”71 at his appearance before the commission, judge connolly claimed—for the first time—that he spoke with [defense attorney #1] on the telephone twice and told [him] to send whatever information he had to present to the court before the hearing, but that he had not received anything from [defense attorney #1].72 the misconduct commission found that statement disingenuous. they noted that “[i]f judge connolly had instructed [defense attorney #1] by telephone to provide the court with whatever he had before the hearing, judge connolly likely would have brought that up during the arraignment.”73 additionally, “[i]nstead of asking [defense attorney #1] why he had not provided the letter to the court before the hearing, judge connolly rebuked him by stating four times that [defense attorney #1] had not come to the courtroom.”74 the commission found that judge connolly’s behavior demonstrated poor demeanor,75 created the appearance of impropriety and failed to promote public confidence in the integrity and impartiality of the judiciary.76 when compiled these actions, like those in previous sections, are indicative of someone who did not appreciate the new covid-19 protocols and attempted to obstruct them by returning to business as normal. another instance in which a judge’s behavior attempted to negatively impact a covid protocol occurred in south carolina. in in re rivers, florence county magistrate jerry fletcher rivers was sanctioned for threatening the chief magistrate while she outlined new covid procedures.77 on may 14, 2020, a meeting was held with magistrates and clerks regarding the plan to re-open magistrates’ court to the public.78 during the meeting, “[magistrate rivers] began asking questions repeatedly, speaking in a loud voice and challenging the chief 69. id. 70. id. at 4. 71. id. 72. id. at 5. 73. id. at 6. 74. id. 75. see e.g., model code of jud. conduct r. 2.8(b) (2020). 76. see e.g., model code of jud. conduct r. 1.2 (2020); see also in re connolly, supra note 58, at 7. 77. see in re rivers, 862 s.e.2d 449 (s.c. 2021) (per curiam). 78. id. 2022] health & justice 395 magistrate's covid-19 safety plan for reopening.”79 as the meeting continued, the magistrate “became visibly agitated, reading aloud portions of the [supreme court’s order regarding the steps courts needed to take to reopen] and challenging the chief magistrate's implementation plan.”80 magistrate rivers’ behavior became so distracting that “[a]t one point during the meeting another magistrate in attendance told [him] to follow the chief magistrate's direction.”81 ultimately, the chief magistrate ended the meeting due to magistrate rivers’ antics.82 enraged by the dressing-down, magistrate rivers “exited the meeting room and confronted the magistrate who suggested he follow the chief magistrate's directions” and “expressed his displeasure and told the other magistrate not to disrespect him again.”83 magistrate rivers then returned to the meeting room and advanced toward the chief magistrate while “hitting his hands together and loudly requesting that going forward the chief magistrate should show him respect.”84 the next day the chief magistrate filed a report with the misconduct commission.85 a month later, while the investigation was still pending, magistrate rivers told a clerk’s office employee that the “chief magistrate ‘does not know who she is dealing with, and she will regret doing this.’”86 for this threatening behavior the magistrate was placed on an interim suspension.87 in the end, magistrate rivers was suspended for six months.88 the supreme court found that the magistrate’s “disruptive behavior reflected poorly on his professional judgement and temperament.”89 they found that magistrate rivers failed to avoid impropriety and the appearance of impropriety and failed to cooperate with other judges and court officials in the administration of court business.90 with this decision the supreme court made it clear that allowing your feelings to override your responsibilities as a judge would not be tolerated. the opinion acknowledged the magistrate’s concerns but impressed upon him that the way he conveys those concerns is paramount. appropriately, the court removed the magistrate from office for a definite period to relay the message that no amount of intimidation tactics will prevent the court from implementing protocols that safeguard the health and wellbeing of the public. 79. id. at 449-50. 80. id. at 450. 81. id. 82. id. 83. id. 84. id. 85. id. 86. id. 87. id. 88. id. 89. id. 90. id. 396 indiana health law review [vol. 19:387 d. failed covid-19 marketing strategy the final example demonstrating how judges have negatively impacted covid protocols centers around judicial commentary. in in re ledsinger, tennessee’s coffee county general sessions judge jere ledsinger was disciplined for making a racially insensitive statement.91 on july 16, 2020, while before an audience of criminal defendants, some of whom were african american, judge ledsinger tried to quell the discontentment surrounding the mask mandate.92 he attempted this feat by trying to invoke the common enemy theory, the phenomenon that members of a group work together when they face an opponent, although they otherwise have little in common.93 the “common enemy” in this example being the tennessee supreme court’s chief justice, who on march 13, 2020, declared a state of emergency for the judicial branch and on july 9, 2020, along with his colleagues, issued an order requiring face masks.94 when the audience bemoaned the constraint, judge ledsinger responded by saying, “the grand wizard of our supreme court said we have to wear these masks.”95 the grand wizard he referenced being the leader of the ku klux klan (“kkk”), “a violent post-civil war secret society founded in tennessee in 1866 to upend the black political and social power that was being established during reconstruction.”96 moving swiftly, the misconduct board launched an inquiry and eventually a full investigation.97 the board was able to get judge ledsinger to admit that he made the comment, that it was improper, and that it created the appearance of impropriety.98 in its order disciplining the judge, the board cited his failure to maintain the highest standards of conduct and dignity.99 more specifically, they scolded judge ledsinger because “a participant in a legal proceeding who hears racially insensitive comments . . . may reasonably perceive that the judge is bias or prejudice, regardless of whether bias or prejudice actually exists.”100 this concern is magnified in tennessee since it is the birthplace of the kkk. 91. letter from dee david gay, bd. chair, state. ten. bd. jud. conduct, to judge jere ledsinger (sept. 28, 2020), https://www.tncourts.gov/sites/default/files/docs/jere_ledsinger_ reprimand_2020_09_28.pdf [https://perma.cc/cx5u-589v]. 92. id. 93. see hans haller & britta hoyer, the common enemy effect under strategic network formation and disruption, 162 j. econ. behav. & org. 146 (2019). 94. in re covid-19 pandemic, order regarding face coverings, tenn. sup. ct., (july 9, 2020), https://www.tncourts.gov/sites/default/files/docs/order_regarding_face_coverings.pdf [https://perma.cc/7b6l-r3s3]. 95. letter from dee david gay, supra note 91. 96. ku klux klan, merriam-webster, https://www.merriam-webster.com/dictionary/ ku%20klux%20klan [https://perma.cc/m33d-66hr] (last visited feb. 25, 2022). 97. letter from dee david gay, supra note 91. 98. id. 99. id. 100. id. 2022] health & justice 397 moreover, if the chief justice is the leader of the kkk, then it would not be unreasonable for a litigant to believe judge ledsinger occupied a lower ranking status of the same domestic terrorist organization. finally, judge ledsinger’s words failed to take into consideration the colonial overtones his statement had on african american who have, as a people, been laboratory subjects for government sponsored treatments (e.g., tuskegee syphilis study, henrietta lacks).101 iv. recommendation each of the above referenced judges understood that a global pandemic arrived which authorized the governor and supreme court to enact emergency protocols to safeguard the public. however, each one misapprehended that their personal views on the appropriate response to the pandemic would usurp the directives of the leaders of each branch of government. each judge erroneously believed that because they disagreed with the prescribed course of action that they could deviate without recourse. if they were normal members of the community that might have been true. unfortunate for them, they are judicial officers held to the highest ethical standards, with the most salient being a requirement to follow and enforce the law. given the clear proclamation, the only conclusion for a failure to follow the law is that their personal biases or outside political influences infiltrated their decision-making processes. to remedy this failure, the judiciary’s education division should institute greater bias training. for example, the training could go beyond the state’s codes of judicial conduct and review international codes of conduct, like the bangalore principles on judicial conduct. perhaps a demonstration that a judicial officer should maintain a bias-free, impartial disposition will be best understood when examined from the perspective of international tribunals who, in some instances, deal with issues not only from different parts of the states, but different parts of the world.102 similarly, it may be useful guidance to review the universal declaration of human rights. for example, a review of how article 10—which principally advocates for fair, impartial tribunals—might prove instructive.103 another component of this training could focus on teaching judicial officers how to properly participate in extrajudicial activities that discuss things like mask mandates and emergency powers of the executive and legislative branches. for example, rule 3.7 of the model code of judicial conduct does say “a judge may participate in activities sponsored by organizations or governmental entities 101. see, e.g., dezimey kum, fueled by a history of mistreatment, black americans distrust the new covid-19 vaccines, time (dec. 28, 2020), https://time.com/5925074/black-americanscovid-19-vaccine-distrust/ [https://perma.cc/eg89-shez]. 102. see the bangalore principles of judicial conduct, united nations off. drugs & crime (2018), https://www.unodc.org/documents/ji/training/bangaloreprinciples.pdf [https://perma. cc/vq7l-lqhp]. 103. see g.a. res. 217 (iii) a, universal declaration of human rights, art. 10 (dec. 10, 1948). 398 indiana health law review [vol. 19:387 concerned with the law, the legal system, or the administration of justice, and those sponsored by or on behalf of educational, religious, charitable, fraternal, or civic organizations not conducted for profit.”104 by exploring the legal avenues available, judges can express their legal curiosity, maintain an outlet for expression, all while understanding their obligations to the populace. more specifically, such an education might illuminate the restrictions being a judge places on your freedoms and aids that person in selecting another profession if they determine the burdens to be onerous. another outlet could be for a judicial officer to donate time or money to non-discriminatory organizations who share similar opinions regarding covid-19 protocols.105 v. conclusion whether judges adhere to the codes of judicial conduct will be entirely up to the agencies who supervise their behavior. nevertheless, when interacting with directives that impact the physical well-being of others, each judge should heed the advice of the supreme judicial court of massachusetts when they said: it is not enough that we know ourselves to be fair and impartial or that we believe this of our colleagues. our power over our fellow citizens requires that we appear to be so as well. how else are ordinary citizens to have the faith in us that we have in ourselves . . . [?] an impartial manner, courtesy, and dignity are the outward sign of that fairness and impartiality we ask our fellow citizens, often in the most trying of circumstances, to believe we in fact possess. surely it is arrogance for us to say to them that we may not seem impartial, but we know we are, and so they must submit. precisely because the public cannot witness, but instead must trust, what happens when a judge retires to the privacy of [their] chambers, the judiciary must behave with circumspection when in the public eye.106 104. see model code of jud. conduct canon 3, r. 3.7 (2020). 105. see, e.g., model code of jud. conduct canon 3, r. 3.6(a) (2020) (prohibits judges from having memberships in any organization that practices invidious discrimination on the basis of race, sex, gender, religion, national origin, ethnicity, or sexual orientation). 106. in re brown, 691 n.e.2d 573, 576 (mass. 1998). financial conflicts in the new era of sunshine: what we know and still need to know © richard s. saver * abstract the health care system has entered a new era of sunshine about financial conflicts. disclosure, an increasingly favored regulatory approach, significantly expanded with enactment of the physician payments sunshine act, the first comprehensive federal legislation mandating public reporting of payments between industry and medicine. but is it making any difference? and what is all the increased disclosure actually revealing? this article critically analyzes the mixed experience with the sunshine act, what has been learned from the information generated, and the ramifications for health law and policy. this article also considers how, even in the new era of sunshine, many still important unknowns remain that complicate and potentially undermine successful financial conflicts regulation. one clear lesson from the sunshine act is that inherent implementation challenges, such as data identification and translation, can seriously undermine transparency as a regulatory tool. there are considerable doubts whether the law will significantly impact decision-making of primary audiences such as patients and physicians. at the same time, the sunshine act has generated valuable information about the nature and scope of financial ties between industry and medicine, such as variations by clinical specialty, type of payment, and physician gender, all of which have important implications for health law and policy and can inform future regulation. notwithstanding greater transparency, a great deal unfortunately still remains unknown. a critical need for more evidentiary support exists in several key areas, including the actual causal impact of financial conflicts, the optimal way to disclose conflicts, what patients really think about financial relationships with industry, and the role of institutional conflict of interest committees in monitoring financial ties. i. introduction financial conflicts pervade modern medicine. according to data from the1 * arch t. allen distinguished professor, unc school of law; professor (secondary appointment), unc school of medicine; adjunct professor, unc gillings school of global public health. thanks to participants at the indiana health law review symposium and the unc faculty workshop series for helpful comments. special thanks to kerry dutra and mackenzie dickerman for excellent research assistance. 1. the terms “financial conflicts” and “conflicts of interest” are used throughout this article as defined by the institute of medicine. a health care provider’s primary interests include rendering professional care to patients, engaging in credible, ethical research, and supporting quality medical education. inst. of med. of the nat’l acads., conflict of interest in medical research, education, and practice 6 (bernard lo & marilyn j. field, eds., 2009) [hereinafter iom conflict of interest report]. a “conflict of interest” involves “circumstances that create a risk http://doi.org/10.18060/3911.0044 68 indiana health law review [vol. 15:67 physician payments sunshine act (sunshine act), nearly half of all physicians2 (48%) received some form of payment from drug companies and device manufacturers in 2015. patients have broad exposure to physicians under3 financial influence, with estimates suggesting about two-thirds of patients see physicians receiving industry payments. the high prevalence of financial4 conflicts raises numerous concerns for health law and policy. the institute of medicine’s conflict of interest report, for example, warns that medicine’s financial ties to industry can harm patient care, increase costs, limit choice, erode trust, and threaten the integrity of medical research.5 it is tempting to view the sturm und drang about financial conflicts in health care as relatively new, resulting from medicine’s increased commercialization and the expanded influence of drug companies and device manufacturers. however, financial conflicts of interest in health care have been long-standing. also long-6 standing have been confusion and disagreements about how best to address them. indeed, “[t]he problem of pharmaceutical promotion . . . presents an enduring dilemma.” financial conflicts in health care raise continual, thorny challenges7 for regulation, ranging from correctly identifying the problematic financial ties, to developing effective management strategies when the evidence base remains limited for many interventions, to avoiding deterrence of innovation and beneficial industry-medicine collaborations. what is new about this enduring dilemma is far greater transparency. disclosure about financial conflicts in health care, an increasingly favored regulatory approach, received a significant boost in 2010 from enactment of the sunshine act, the first comprehensive federal legislation mandating public reporting of payments between industry and medicine. the health care system has entered a new era of sunshine about financial conflicts. but is it making any difference? and what is all the increased disclosure actually revealing? to address these questions, this article critically analyzes the experience with the sunshine act. the legislation offers an unprecedented opportunity to evaluate the effectiveness of financial conflicts disclosure on a wide scale. the law so far has a very mixed, uneven record. among other limitations, the sunshine act demonstrates that commanding transparency through legislation is both difficult that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest,” such as financial gain. id. 2. physician payments sunshine act of 2010, pub. l. no. 111-148, § 6002, 124 stat. 689 (codified at 42 u.s.c. § 1320a-7h). 3. kathryn r. tringale et al., types and distributions of payments from industry to physicians in 2015, 317 jama 1774, 1774 (2017). 4. genevieve pham-kanter et al., public awareness of and contact with physicians who receive industry payments: a national survey, 32 j. gen. internal med. 767, 770 (2017). 5. iom conflict of interest rep., supra note 1, at 23, 27. 6. abigal zuger, what do patients think about physicians’ conflict of interest? watching transparency evolve, 317 jama 1747, 1747 (2017). 7. scott h. podolsky & jeremy a. green, a historical perspective of pharmaceutical promotion and physician education, 300 jama 831, 833 (2008). https://doi.org/10.1001/jama.2017.3091 https://doi.org/10.1007/s11606-017-4012-3 https://doi.org/10.1001/jama.2017.2995 https://doi.org/10.1001/jama.300.7.831 2018] financial conflicts in the new era of sunshine 69 and can have unintended effects. the law has encountered serious implementation challenges in its rollout and uncertainty remains about the intended audiences and their ability to use the information about financial relationships effectively. at the same time, the sunshine act is generating the most comprehensive data to date about the nature, scope, variation, and pervasiveness of financial ties between industry and medicine. as this article explores, this information has important implications for health law and policy. it offers valuable guidance for evidence-based regulation of financial conflicts moving forward, such as identifying predictors of significant financial entanglement and facilitating tailored regulatory responses depending on differing clinical contexts. this article is part of a symposium that asks “what works and what doesn’t work?” in various areas of health law and policy. as applied to financial conflicts of interest regulation, answering these questions remains difficult, given the limited evidence base for many regulatory interventions. an equally important, threshold set of questions to ask: (1) what do we know and (2) what do we still need to know? the sunshine act’s greatest and likely most sustaining contribution is helping address the first question. because of the law, we know a great deal more about the epidemiology of industry-medicine financial ties, such as the incidence, distribution, and predictive factors for financial conflicts, and this data can inform future regulation. however, as explained further below, there is also strong reason to doubt that the sunshine act’s increased transparency will result in significant changes in patient and physician decision-making. moreover, notwithstanding increased transparency, a great deal still needs to be known about financial conflicts regulation. evidentiary support remains critically missing on key issues. this article identifies several of the important remaining unknowns. part ii of this article describes the sunshine act’s basic requirements and how it expands upon and amplifies previous disclosure laws and policies. part iii explores many of the stumbles encountered in the sunshine act’s rollout and the considerable implementation challenges in identifying and communicating the data about industry-medicine financial ties. it also considers the uncertainty about the intended audiences, the considerable doubts about their ability to act on the information, and the possible unintended effects of mandatory disclosure. part iv analyzes what the sunshine act has revealed about industry-medicine financial ties and the important ramifications for evidence-based regulation of financial conflicts. part v considers how, even in the new era of sunshine, significant unknowns about financial conflicts remain that complicate and potentially undermine effective regulation. these include the actual causal impact of financial conflicts, the comparative effectiveness of different regulatory approaches, the optimal methods for disclosing financial relationships, what patients really think about financial conflicts, and the appropriate role of institutional conflict of interest committees in the monitoring of financial ties. part vi concludes. ii. sunshine act and the open payments database the sunshine act, enacted in 2010 as part of the larger affordable care act, 70 indiana health law review [vol. 15:67 is the first comprehensive federal legislation to require reporting of industrymedicine financial relationships. the law does not prohibit or otherwise alter the financial relationships that can be created. but it does impose the reporting requirement, a form of regulation by transparency which, in theory, advances important goals. public disclosure of financial ties, by subjecting the parties to increased scrutiny and market pressures, may deter problematic industrymedicine financial relationships. further, increased transparency may facilitate8 improved decision-making by patients, physicians, and other stakeholders.9 the sunshine act applies to drug companies and medical device firms manufacturing products covered by medicare, medicaid, or the children’s health insurance program. these manufacturers, as well as group purchasing10 organizations, must report annually to the federal government if they have physician owners or investors. in addition, manufacturers must report annually11 all “transfers of value” to physicians and teaching hospitals. a “transfer of12 value” is defined broadly and can cover not only direct monetary payments but provision of food, lodging, equipment and other items of tangible value. the13 centers for medicare and medicaid services (cms) compiles the reported data and releases it on a publicly available and searchable website, known as the open payments database. physicians have the opportunity to review the manufacturer14 reports online during a limited forty-five day time window before public posting by cms to the open payments database and they may access a dispute resolution process if they disagree with particular reports. 15 even small dollar financial relationships need to be reported. payments of greater than $10 per instance or $100 per year must be disclosed as “transfers of value.” in addition, in reporting each payment a manufacturer must place it16 within a limited number of categories defined by the statute and implementing regulations, such as consulting fees, travel and lodging, research payments, royalty and license fees, and grants. manufacturers began collecting data in17 8. alison hwong & lisa lehmann, putting the patient at the center of the physician payment sunshine act, health aff. blog (june 13, 2012), http://healthaffairs.org/blog/ 2012/06/13/putting-the-patient-at-the-center-of-the-physician-payment-sunshine-act/ [https://perma.cc/6h4e-eu3z]. 9. medicare, medicaid, children’s health insurance programs; transparency reports and reporting of physician ownership or investment interests, 78 fed. reg. 9458, 9458-59 (2013) (codified at 42 c.f.r. pts. 402, 403). 10. 42 u.s.c. § 1320a-7h(a)(1)(a), (e)(2), (e)(4), (e)(5) (2012). 11. 42 u.s.c. § 1320a-7h(a)(2). 12. 42 u.s.c. § 1320a-7h(a)(1), (e)(6). 13. 42 u.s.c. § 1320a-7h(e)(10). 14. see open payments, ctrs. for medicare & medicaid servs., https://www.cms.gov/ openpayments/ [https://perma.cc/bdp7-veje] (last modified july 11, 2017, 1:32 pm). 15. 42 c.f.r. § 403.908(g). 16. 42 u.s.c. § 1320a-7h(e)(10); 42 c.f.r. § 403.904(h). 17. 42 u.s.c. § 1320a-7h(a)(1)(a)(vi); 42 c.f.r. § 403.904(e)(2) (providing that the possible payment categories are consulting fees, compensation for non-consulting services such as 2018] financial conflicts in the new era of sunshine 71 august 2013 and reporting it to the government in march 2014. cms has released the data in batches. industry-medicine financial transactions currently posted to the open payments database cover the latter part of 2013, and all of 2014–2016.18 manufacturers who violate the reporting requirements risk civil fines up to $10,000 for each violation, capped annually at $150,000. knowing violations19 are subject to civil fines of up to $100,000 for each incident, capped annually at $1 million. the fines are one-sided in application. recipients of payments, such20 as physicians and teaching hospitals, have no direct reporting obligation. instead the manufacturers making the payments bear the full reporting burden and face possible sanction for non-compliance. the sunshine act expands upon and amplifies previous disclosure laws and programs. as for institutional policies and rules, many medical journals now require authors to disclose financial relationships with industry. similarly, health care21 institutions commonly have internal policies requiring medical staff to disclose industry financial ties to conflicts of interest committees within their institution for further evaluation and management. as for direct reporting laws, a handful22 of states, such as massachusetts, minnesota, and vermont, have previously enacted their own sunshine laws, but the state laws vary in terms of the23 minimum value that triggers reporting of payments, the exceptions that apply, and other material terms. also, the department of justice has negotiated fraud and abuse settlements with several pharmaceutical companies, such as eli lilly and co., requiring public disclosure of their payments to physicians. 24 speaker fees, honoraria, gifts, entertainment, food and beverage, travel and lodging, education, research-related payments, charitable contributions, royalties and license fees, payments related to ownership and investment interests, speaker/faculty fees for non-accredited educational events, speaker/faculty fees for accredited continuing education programs, grants, and space rental or facility fees). 18. see open payments, supra note 14. 19. 42 u.s.c. § 1320a-7h(b)(1). 20. 42 u.s.c.§ 1320a-7h(b)(2). 21. see, e.g., int’l comm. med. j. editors, form for disclosure of potential conflicts of interest, icmje, http://www.icmje.org/conflicts-of-interest/ [https://perma.cc/67ut-3cjh] (last visited june 23, 2017). 22. see, e.g., u. mich. office of res., conflict of interest, res. ethics & compliance u. mich. (march 31, 2017), http://research-compliance.umich.edu/conflict-interest-coi [https://perma.cc/f3p4-etex]; wfbmc conflict of interest office, policy on conflict of commitment and conflict of interest, wake forest baptist med. ctr. 8&9, file:///c:/users/ sdrs8/downloads/approved%20mcconnell_coi_policy%202012_09_05[1]%20(1).pdf [https://perma.cc/pqt6-y7yh] (last updated aug. 24, 2012). 23. see mass. gen. laws ch. 111n, § 6 (2012); minn. stat. § 151.47(f) (2013); vt. stat. ann. tit. 18, § 4632 (2016). 24. eli lilly & co. agrees to pay $1.415 billion to resolve allegations of off-label promotion of zyprexa, dep’t of justice (jan. 15, 2009), https://www.justice.gov/archive/opa/pr/ 72 indiana health law review [vol. 15:67 federal regulations also require reporting of certain medical industry financial ties, but these apply only in the research context. national institutes of health (nih) regulations require grantees to disclose to their institutions significant financial ties ($5,000 or more) with industry and the institutions, in turn, to disclose how they managed perceived financial conflicts to the public health service. meanwhile food and drug administration (fda) rules require25 a company seeking fda approval of its product to report to the agency certain financial relationships (payments over $25,000 and equity interests over $50,000) with clinical investigators testing the product in fda-regulated clinical trials.26 the sunshine act thus breaks new ground as the first comprehensive reporting program and it establishes uniform requirements through federal law. it is also far broader than the previous laws and disclosure programs, as it has a low dollar threshold to trigger reporting and more types of transactions are generally covered. in addition, the public can more easily access the information in the open payments database than the information disclosed under several of the state sunshine laws and settlement agreements.27 iii. implementation challenges and unintended effects the sunshine act has been bedeviled by considerable implementation problems. its troubled rollout demonstrates that despite the theoretical appeal of disclosure as a regulatory tool, challenges in data selection and communication, which arise in many disclosure programs, make achieving meaningful transparency in action quite difficult. in addition, there is reason to doubt that increased transparency will result in significantly changed medical decisionmaking by primary audiences such as patients and physicians. moreover, mandatory disclosure can have unintended effects. a. data gathering a well-functioning transparency program depends, in the first instance, on selecting representative data to disclose. unfortunately, gathering all the relevant information regarding industry-medicine financial ties has proven to be disappointingly difficult. this is understandable because of the many moving 2009/january/09-civ-038.html [https://perma.cc/8gdg-m6ck]; corporate integrity agreement between the office of inspector general of the department of health and human services and eli lilly and company, sec.gov, 28-29 (jan. 14, 2009), https://www.sec.gov/archives/edgar/ data/59478/000095015209001897/c49534exv10w17.htm [https://perma.cc/8qnx-k9tb]. 25. 42 c.f.r. §§ 50.601–605; 45 c.f.r. §§ 94.1–5. 26. 21 c.f.r. pt. 54. 27. for example, minnesota’s sunshine law initially provided only public access to the data on paper, with no aggregate reports made available to the public, while west virginia’s law required disclosure of payments to state regulators but did not make this information, in turn, readily available to the public. see susan chimonas et al., show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws, 45 health servs. res. 98, 100 (2010). https://doi.org/10.1111/j.1475-6773.2009.01048.x 2018] financial conflicts in the new era of sunshine 73 parts. financial ties between industry and medicine arise in a complex web of relationships between individual physicians, larger medical groups, hospitals, multi-provider health systems, drug companies, device manufacturers, wholesalers, distributors, educational and conference providers, and research support organizations, among others. further, financial influence can take many forms, such as returns to physician investors, direct payments for services such as consulting, research grants, educational support, and intellectual propertyrelated fees. against this backdrop, the sunshine act, while broad in scope, still misses important data points. for one, it fails to account for all important recipients of industry payments. according to the statute, transfers of value to “physicians” must be reported.28 cms interprets this provision as requiring the disclosure of payments to a physician licensed and legally authorized to practice medicine in any state.29 under this interpretation, payments to medical residents, nurse practitioners, physician assistants and other ancillary personnel are excluded from the reporting obligation. medical residents and ancillary providers are, however, in an30 important position to make referrals and prescriptions as they have independent prescribing authority in several states and otherwise can generate significant referrals. they also have financial entanglements with industry similar to31 physician-industry financial relationships. it can be expected that these32 providers will be additional targets of industry financial influence and that manufacturers, wary of reporting to the open payments database, will restructure transactions and allocate more industry spending toward residents and nonphysician personnel. as a result, the sunshine act may end up obscuring important new forms of financial influence in the health care market. in addition, focus group research indicates that many physicians view the sunshine act as unfair because of its focus only on physician interactions with industry and not potentially conflicting relationships between other prescribers and industry.33 this perceived disparity contributes to physician distrust and cynicism about the 28. 42 u.s.c. §§ 1320a-7h(a)(1)(a), (e)(6) (2012). 29. medicare, medicaid, children’s health insurance programs; transparency reports and reporting of physician ownership or investment interests, 78 fed. reg. 9458, 9466 (feb. 8, 2013) (codified at 42 c.f.r. § 403.902). 30. id. at 9467. 31. nurse practitioners and physician assistants wrote approximately ten percent of all prescriptions in 2013 under medicare’s part d prescription drug program and they are among the top prescribers for certain narcotic controlled substances. charles orenstein, transparency program obscures pharma payment to nurses, physician assistants, propublica (july 6, 2015), https://www.propublica.org/article/transparency-program-obscures-pharma-payments-nursesphysician-assistants [https://perma.cc/pp9z-c9lc]. 32. see, e.g., quinn grundy et al., marketing and the most trusted profession: the invisible interactions between registered nurses and industry, 164 annals internal med. 733, 735 (2016). 33. susan chimonas et al., powered by sunshine: next steps for making transparency matter, 17 am. j. bioethics w1, w1 (2017). https://doi.org/10.7326/m15-2522 https://doi.org/10.1080/15265161.2017.1324584 74 indiana health law review [vol. 15:67 law, making it more difficult to enforce. the sunshine act also misses important data with regards to the entities making payments. the statute imposes reporting obligations only on manufacturers (and, in more limited circumstances, gpos). cms has interpreted this to mean that only companies that have title to a drug, device, or other reimbursable product must report their payments to physicians. however, before34 a product reaches the market, and is ordered by a physician, it often passes through other entities in the production chain, such as wholesalers and distributors. because these downstream entities economically benefit from greater utilization of the product, they also have an interest in wielding financial influence over health care providers to induce more prescriptions and referrals. but when wholesalers and distributors (if not also holding title to the product) enter into financial relationships with physicians, the transactions are not reported to the open payments database. not only does this obscure important sources of financial influence, it may encourage manufacturers to evade reporting obligations by restructuring transactions to make greater use of downstream entities as the source of payments. 35 data glitches have also arisen because of the difficulty, given the complex web of industry-medicine financial ties, keeping straight which companies and which medical products are involved in a financial relationship. reporting into the open payments database has not always been consistent. for example, multiple corporate affiliates can make payments to the same physician with regard to the same drug or device. each payment is reported separately by the36 distinct corporate affiliate’s name. many end-users of the open payments database may be unaware when related corporate entities are making coordinated payments, as the distinct payment reports are not linked and the companies’ affiliation may not be common knowledge or apparent from name alone. likewise, despite the expectation that each payment report will identify which product was involved in the disclosed financial relationship, manufacturers have submitted several reports with no identified drug or device to match to a payment, or with more than one underlying drug or device and no breakdown of how much 34. medicare, medicaid, children’s health insurance programs; transparency reports and reporting of physician ownership or investment interests, 78 fed. reg. 9458, 9461–62 (feb. 8, 2013) (codified at 42 c.f.r. pts. 402, 403). 35. a manufacturer that tries to “pass through” payments to physicians by first paying a distributor, which, in turn, relays the funds to the physician, would still likely have to report such payments as the sunshine act does require reporting of indirect payments. see 42. c.f.r. § 403.902 (definition of “indirect payments or other transfers of value”). however, more sophisticated business models where the cooperating distributor is arguably making the physician payment independently, and not under the control or direction of the manufacturer, would likely not trigger reporting as indirect payments. 36. see charles ornstein et al., data on payments from drugmakers to doctors is marred by error, n.y. times (jan. 22, 2015), https://www.nytimes.com/2015/01/23/upshot/data-onpayments-from-drugmakers-to-doctors-is-marred-by-error.html [https://perma.cc/rs6f-b94d]. 2018] financial conflicts in the new era of sunshine 75 of the payment was allocated to each product. as a result of such data glitches,37 the full extent of financial influence behind a particular drug or device at times remains obscured even after disclosure into the open payment database. one supposed advantage of the sunshine act, compared to many previous disclosure programs, is that it does not depend upon physician reporting. the reporting obligations fall entirely upon manufacturers, the entities making payments. previous disclosure programs have been marred by low physician compliance in identifying and disclosing payments, perhaps because physicians38 are already over-burdened by other reporting obligations or because they cannot keep accurate track of all the payments they typically receive from multiple sources, and may be reluctant to draw attention to their receipt of payments. however, putting reporting obligations entirely on manufacturers has not fully avoided the challenge of ensuring physician compliance. physicians are not fully engaging with the data. in the beginning of the open payments database rollout, a sizeable number of physicians did not fully participate in the verification process, meaning that much of the posted data had not been fully vetted. according to a market research survey conducted several weeks after the39 open payments database went public, only 46% of physicians reported having checked the website, for reasons ranging from curiosity to verifying the accuracy of payments reported to them. other physicians who did register and identified40 payment reports they thought inaccurate complained about the inability to get the information timely corrected and problems with the dispute resolution process.41 these problems may be arising in part because of the misaligned incentives under the sunshine act for reporting compliance. companies can incur substantial fines for insufficient reporting of their payments to physicians. they42 may be inclined to err on the side of over-reporting, identifying some payments even if unsure really whether they needed to be reported or if unsure which 37. id. 38. see iom conflict of interest report, supra note 1, at 63; kanu okike et al., accuracy of conflict-of-interest disclosures reported by physicians, 361 new eng. j. med. 1466, 1470–71 (2009); gardiner harris, top psychiatrists didn’t report drug makers’ pay, n.y. times (oct. 3, 2008), http://www.nytimes.com/2008/10/04/health/policy/04drug.html [https://perma.cc/ e9fw-zqn5]. 39. sachin santhakumar et al., the physician payment sunshine act: testing the value of transparency, 313 jama 23, 23 (2015) (noting that only 4.8% of physicians and 29.8% of teaching hospitals engaged in the vetting process for the 2013 open payments data). 40. ed silverman, what money? many docs haven’t visited the open payments database, wall st. j. (feb. 20, 2015), https://blogs.wsj.com/pharmalot/2015/02/20/what-money-most-docshavent-visited-the-open-payments-database/ [https://perma.cc/cy2z-9f83]. 41. elizabeth richardson, health policy briefs: the physician payments sunshine act, health aff. 1, 4 (oct. 2, 2014), http://www.healthaffairs.org/healthpolicybriefs/brief.php? brief_id=127 [https://perma.cc/vz57-amg8]; see also susan chimonas et al., bringing transparency to medicine: exploring physicians’ views and experiences of the sunshine act, 17 am. j. bioethics 4, 10 (2017) (noting that physician participation “has been exceedingly low”). 42. see 42 u.s.c. § 1320a-7h(b) (2012). https://doi.org/10.1056/nejmsa0807160 https://doi.org/10.1001/jama.2014.15472 https://doi.org/10.1080/15265161.2017.1313334 76 indiana health law review [vol. 15:67 physician recipients were involved. physicians, however, face no direct sanctions under the sunshine act as to whether their financial relationships were reported inaccurately or not at all. thus, physicians have limited direct incentives to engage with and verify the data. while presumably reputational concerns associated with public disclosure would motivate a fair number of physicians to want to review the accuracy of reports appearing in the open payments database, physician engagement still could be considerably improved. b. data translation and communication a successful transparency program attends to data translation and communication. even with the most accurate and meaningful information gathered, a disclosure program can be rendered ineffective by how the data is interpreted and displayed. there is considerable risk that end users may simply tune out, misinterpret, or fail to engage with the disclosed information. thus, effective disclosure programs translate the gathered data in a way that is comprehensible to end-users and compatible in format and other features with their typical decision-making so that the information likely becomes “embedded” in user decisions. likewise, end users must obtain the relevant data with low43 enough information costs to justify their expected benefits, and end users must perceive that the information has value because they are in a position to act on and make meaningful choices with the information. 44 like many transparency programs, the sunshine act struggles with these inherent challenges in data translation and communication. presenting the information in a manner compatible with patient decision-making and facilitating comprehension about industry-medicine financial ties proves enormously difficult. a problem fundamental to financial conflicts disclosure is how to provide all the information actually relevant to the risk of bias? the literature on physician financial incentives cautions that there is a great deal more to consider than simply the amount of money conveyed. risk of bias and undue influence45 in an industry-medicine financial relationship depends on number of variables, including the amount of money at stake, but importantly also how the payment compares relative to the recipient physician’s other sources of income, the nature of physician services involved in the transaction, the historical relations between the transacting parties and any power imbalances that may exist, how long the financial relationship will continue, the number of patients affected, whether many other physicians enjoy the same financial relationship with the company, 43. archon fung et al., full disclosure: the perils and promises of transparency 56–62 (2007). 44. id. at 55–56. 45. see, e.g., bernard lo et al., payments to physicians: does the amount of money make a difference?, 317 jama 1719, 1719 (2017) (“the degree of concern will vary . . . according to the type of financial relationship and the nature of the physician’s advice or activity.”). https://doi.org/10.1001/jama.2017.1872 2018] financial conflicts in the new era of sunshine 77 the recipient physician’s ability to direct referral and prescription decisions for the company’s products, and the physician’s interest in maintaining relations with the company in other settings. how is a transparency program supposed to46 disclose all this, and yet still be easily comprehensible and readily accessible to the public? the architects of the open payments database have opted to keep the disclosure deceptively simple, omitting much of the relevant background and important contextual information. a payment report in the database displays the company and physician/teaching hospital in the transaction, the dollar value conveyed, and the type of payment involved by referencing one of the limited payment categories (consulting, travel/lodging, speaker fees, etc.). end-users do not necessarily understand, from just the associated category descriptor, the fuller context as to what the underlying payments are about and where there may be greater risks of bias and undue influence. as an example, learning that a financial relationship involved “consulting” by the physician to a drug company for a certain dollar amount does not really provide the end user with much relevant information as to the legitimacy of the relationship and the actual risk of bias involved. moreover, in the face of such disclosure, many users will not even know what additional contextual questions to ask. not only does the open payments database omit key contextual information, but the limited information it does display risks skewing patient responses in ways that mask the real risks of bias and undue influence. as noted, particularly prominent in payment reports in the open payments database are the payment amount and type of payment category (consulting fee, research payment, royalty and license fee, etc.). as for payment amount, end users likely instinctively react primarily to this factor, assuming there is greater concern the greater the payment. however, such assumptions reflect misunderstandings about how bias and undue influence arise in industry-medicine financial relationships. the conflict of interest literature cautions that the risk of undue influence and bias does not necessarily correlate with the amount of money at stake. small gifts and de47 minimis payments can also warrant serious concern because of accompanying non-economic influences. the underlying relationships arising from the financial ties, even if involving low dollars, can create indebtedness, unconscious gratitude, 46. see, e.g., richard s. saver, squandering the gain: gainsharing and the continuing dilemma of physician financial incentives, 98 nw. u. l. rev. 145, 207–10 (2003); brian armour et al., the effect of explicit financial incentives on physician behavior, 161 archives internal med. 1261, 1265–66 (2001); patrick l. taylor, innovation incentives or corrupt conflicts of interest? moving beyond jekyll and hyde in regulating biomedical academic-industry relationships, 13 yale j. health pol’y l. & ethics 135, 154–63 (2013). 47. see, e.g., troyen a. brennan et al., health industry practices that create conflicts of interest, 295 jama 429, 430–32 (2006); dana katz et al., all gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving, 10 am. j. bioethics 11, 11–14 (2010) (“[w]hile it might seem both logical and practicable to distinguish small gifts from larger, seemingly more problematic gifts, a large body of evidence from the social sciences shows that behavior can be influenced by gifts of negligible value.”). https://doi.org/10.1001/jama.295.4.429 https://doi.org/10.1080/15265161.2010.519226 78 indiana health law review [vol. 15:67 and reciprocation obligations for the physician recipients. these cumulative48 pressures can exert potential bias in subtle but powerful ways. for example, a49 study of open payments database reports found significant correlation between a physician’s receipt of a single meal (cost around $12-$18) promoting a brand name drug and higher prescribing of that medication relative to alternatives within the same drug class. 50 additional problems arise with the prominence of payment categorization in the open payments database. a study of patient views about financial conflicts, modeled on the sunshine act disclosures, found that patients generally reacted more negatively to a reported financial relationship when the underling payment amount was larger. however, even more salient to patients was the payment51 category, which seemingly exerted strong influence on patient perceptions. for52 example, patients generally viewed physicians who received consulting payments as experts with more knowledge about medical advances. meanwhile,53 physicians paid for travel or with ownership interests were perceived as less trustworthy than physicians receiving other categories of payment, perhaps54 because payments such as travel were viewed as “unearned” by the recipient physicians. other research also indicates that payment categorization influences patient and research subject perceptions to a large degree. 55 thus, open payments database reports may cause patients to react vigorously to some disclosures and minimally to others, if influenced primarily by amount of money involved and payment category. importantly, these skewed responses do not necessarily correspond to the payment’s actual risk of bias and undue influence. for example, despite the perception that industry selects physicians as consultants because of their expertise, fraud and abuse 48. see, e.g., william w. stead, the complex and multifaceted aspects of conflicts of interest, 317 jama 1765, 1765 (2017). 49. see generally jason dana, how psychological research can inform policies for dealing with conflicts of interest in medicine, in iom conflict of interest report, supra note 1, app. d at 358–74. 50. colette dejong et al., pharmaceutical industry-sponsored meals and physician prescribing patterns for medicare beneficiaries, 176 jama internal med. 1114, 1114, 1116, 1121 (2016). the study looked at physician prescribing behavior with regard to statins, angiotensin receptor blockers, selective serotonin reuptake inhibitors and several other commonly prescribed classes of drugs. id. at 1114. 51. joshua e. perry et al., trust and transparency: patient perceptions of physicians’ financial relationships with pharmaceutical companies, 42 j. l. med. & ethics 475, 478, 485 (2014). 52. id. at 475, 478, 485. 53. id. at 484, 487. 54. id. at 480–82, 487. 55. see, e.g., adam licurse et al., the impact of disclosing financial ties in research and clinical care, 170 archives internal med. 675, 678 tbl.2, 680 (2010) (“[w]e find that, across multiple studies, patients and research participants are able to distinguish between different types of [financial relationships] as well as the relative importance of disclosure of each.”). https://doi.org/10.1001/jama.2017.3435 https://doi.org/10.1001/jamainternmed.2016.2765 https://doi.org/10.1111/jlme.12169 https://doi.org/10.1001/archinternmed.2010.39 2018] financial conflicts in the new era of sunshine 79 investigations have revealed various drug companies’ and device firms’ use of consulting payments as schemes to secure physician loyalty. likewise, certain56 small dollar financial ties may warrant vigorous attention and management because they do present real risk of actual bias, even if typical end users would57 assume they have limited impact. further difficulties arise because the open payments database lacks important comparative benchmarks. how a particular physician’s financial relationships compare to peers in the field is very material information for patients and other stakeholders. only in 2017 did cms add at least some comparative information in response to ordinary searches. but this is rather limited, showing how a physician’s payments compare to national and specialty peers, not regional, and not addressing which general payment categories are involved.58 missing contextual and comparative information are recurring problems for transparency programs generally. this information is often necessary for the disclosures to be meaningful, accurate, and practical to end users. however, for certain complex topics such as financial conflicts, this means a great deal of additional contextual and comparative information will need to be disclosed. the more that needs to be disclosed, the greater the risk that the transparency program overloads end-users with too much information and additional search costs, and displays the information in formats that are not likely to be compatible with their typical decision-making. the sunshine act demonstrates that, at bottom, achieving transparency that is simultaneously accurate, meaningful, comprehensible, accessible, and compatible with end users’ decision-making frequently requires working at cross purposes. c. audience and unintended effects to be truly effective, a disclosure program needs to account for the needs and abilities of the targeted information recipients. the sunshine act lacks this finetuned design. indeed, uncertainty remains as to who is the intended audience? regulatory guidance from cms has been unclear, mentioning that “the public” will be able to use the open payments database information to make informed 56. see, e.g., avoiding medicare fraud and abuse: a roadmap for physicians, ctrs. for medicare & medicaid servs. 8 (august 2016), https://www.cms.gov/outreach-ande d u c a t i o n / m e d i c a r e l e a r n i n g n e t w o r k m l n / m l n p r o d u c t s / d o w n l o a d s / avoiding_medicare_fanda_physicians_factsheet_905645.pdf [https://perma.cc/e695-w6qp]; united states of america v. reinstein, 1:12cv09167, wl 9307035 (n.d. ill. feb. 13, 2015); press release, dep’t of justice, drug maker forest pleads guilty to pay more than $313 million to resolve criminal charges and false claims act allegations, justice news (sept. 15, 2010), https://www.justice.gov/opa/pr/drug-maker-forest-pleads-guilty-pay-more-313-million-resolvecriminal-charges-and-false [https://perma.cc/9g4r-lyy5]. 57. see lo, supra note 45, at 1720. 58. see open payments data, ctrs. for medicare & medicaid servs., https://openpaymentsdata.cms.gov/ [https://perma.cc/a7us-5g4l]. 80 indiana health law review [vol. 15:67 decisions about their health care, and otherwise being vague as to specific audiences.59 1. patients patients presumably form part of the core intended audience. but the sunshine act’s disclosure program seems poorly designed for patients’ abilities and preferences and its direct impact on patient decision-making remains questionable for several reasons. first, the search costs for patients may dissuade many from using the open payments database. while searching an electronic database with simple name queries may not seem daunting, patients must factor this in along with the many other searches they ordinarily have to undertake in arranging for treatment, such as finding an available physician that is covered by the patient’s insurance, evaluating the physician’s qualifications, and ascertaining the cost and quality of proposed treatments. data about financial ties may simply be less salient, or not worth the effort due to informational fatigue, in light of all the other search costs patients typically must endure. another reason to question patient engagement with financial conflicts information concerns the timing of disclosure. many healthy patients might agree, in the abstract, that they would want to know information about provider financial conflicts of interest because this could affect them therapeutically and financially. but most patients must engage with this information when they are sick and seeking treatment. in these circumstances, financial conflicts information may be more easily tuned out as extraneous to the more immediate questions of proposed treatments and their risks and benefits. “when people get sick, all they really want is to get well again, and even the enlightened 21st century patient undoubtedly cares much less about how that happens than it happens at all.”60 in fact, the early sunshine act data indicates that patients are engaging with the information in only modest numbers. from september 30, 2014 to august 1, 2015, the open payments database received 1.1 million page views from visitors. during the same time period, data within the open payments database61 59. see ctrs. for medicare & medicaid servs., annual report to congress on the open payments program 2 (2016) [hereinafter 2016 cms annual report to congress] (“this public website is designed to increase access to, and knowledge about, healthcare industry financial relationships and provide the public with information to enable them to make informed decisions about their healthcare.”); open payments data in context, ctrs. for medicare & medicaid servs., https://www.cms.gov/openpayments/about/open-payments-data-incontext.html [https://perma.cc/26hf-9hje] (last modified nov. 28, 2016, 6:57 am) (“open payments means different things to different people and audiences. for patients, consumers, and the public, open payments can be used to learn about the relationships between physicians and applicable manufacturers and gpos. . . . for physicians and teaching hospital representatives, reviewing the data reported about you in the open payments system can ensure that this information is accurate. you can also . . . use the information reported about you to plan for questions from patients.”). 60. zuger, supra note 6, at 1748. 61. ctrs. for medicare & medicaid servs., annual report to congress on the open payments program 20 (2016). 2018] financial conflicts in the new era of sunshine 81 was searched over 6.5 million times and data downloaded close to 50,000 times.62 it is not clear whether this volume of page views and searches was undertaken primarily by patients, or by physicians, companies, information intermediaries, or other stakeholders. nonetheless, even if this volume represented entirely patient searches, it still is a relatively small number when one considers there are over 57 million patients enrolled in the medicare program alone, and the open63 payments database covers financial relationships related to products covered not only by medicare but also medicaid and the children’s health insurance program. likewise, physician focus group participants indicate that their patients are not asking about any information appearing in the open payments database,64 suggesting limited patient engagement with the data. some commentators are optimistic that over time more patients will interact with the open payments database as general awareness of the sunshine act increases, but this remains65 to be seen. moreover, while patients may desire to learn about financial conflicts, this does not mean they are prepared to seek out this information themselves. the open payments database assumes patients have the inclination to engage with and search the database on their own and can ask follow-up questions to their physicians later. but a recent focus group survey indicates that patients have a strong preference not to learn of financial conflicts via searchable websites, and instead desire live discussion of the conflict with their physicians during an office visit oriented around the treatment for which the financial relationship is relevant. as the sunshine act rollout demonstrates, there is a key distinction in66 disclosure programs between making information accessible to patients and ensuring that the information is actually accessed by patients. more generally, financial conflicts disclosures to patients can have limited impact or even counterproductive effects. as noted previously, patients may not recognize the many contextual factors that increase the risk of undue influence and bias in a financial relationship. instead, they may react more strongly to information about the dollar amount of payment, or how a payment is categorized, and may not even know what further questions to ask. other67 behavioral research suggests that disclosure can have unintended consequences for patients. in the face of financial conflicts information, patients may experience “insinuation anxiety” to follow the physician’s recommendation, as to not follow 62. id. 63. medicare enrollment dashboard, ctrs. for medicare & medicaid servs. (april 2017), https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andreports/dashboard/medicare-enrollment/enrollment%20dashboard.html [http://perma.cc/7gldr6dy]. 64. chimonas et al., supra note 41, at 7. 65. see joseph s. ross, having their cake and eating it too: physician skepticism of the open payments program, 17 am. j. bioethics 19, 20 (2017). 66. j. michael oaks et al., how should doctors disclose conflicts of interest to patients; a focus group investigation, 98 minn. med. 38, 40–41 (2015). 67. see supra notes 46–55 and accompanying text. https://doi.org/10.1080/15265161.2017.1313340 82 indiana health law review [vol. 15:67 it would send an implied message that the patient believes the physician is dishonest, something the patient prefers to avoid. also, perhaps counter-68 intuitively, patients may become more trusting of the physician after a financial conflicts disclosure because the act of disclosure may signal the physician’s candor and openness. even if a patient might be on guard and want to discount69 a conflicted physician’s recommendation, the patient may be unsure how much actually to discount.70 moreover, a growing body of research suggests that financial ties disclosures have limited sway over patient/research subject decision-making, possibly because they care more about other factors or may not appreciate the true risk posed by conflicted financial ties. many patients and subjects report that they would like to know about financial ties, but far fewer report that this information would cause them to change their choice of treatment or provider. for example, a majority of research subjects consider it acceptable for an investigator to own stock in the company making the experimental drug or to have a consulting agreement with the company sponsoring the research. a survey of orthopedic71 surgery patients indicated that a large majority of the patients would want to know if their doctor was involved with industry in design of a device the doctor was recommending. at the same time, a majority of the same patients were72 nonetheless not bothered by surgeons paid to act as consultants for device manufacturers in this manner and an even larger majority of patients viewed it as beneficial if their doctor could provide consulting advice to device manufacturers. a more systematic review of several previous studies and73 surveys indicates that while a majority of patients and subjects say they wish to know about financial ties, only smaller numbers indicate that this information would affect their decision-making about the type of clinical care to receive or whether to participate in research.74 finally, patients may not be in a position to act on their concerns about financial conflicts. they may have insurance coverage with limited provider networks, where changing physicians is not always readily feasible. there may also be a limited number of available physicians in the area who do not have the 68. george loewenstein et al., the unintended consequences of conflict of interest disclosure, 307 jama 669, 669–70 (2012). 69. george loewenstein et al., the limits of transparency: pitfalls and potential of disclosing conflicts of interest, 101 am. econ. rev. 423, 424 (2011). 70. id. at 424. 71. lindsay a. hampson et al., patients’ views on financial conflicts of interest in cancer research trials, 355 new eng. j. med. 2330, 2330 (2006). 72. m.h. khan et al., the surgeon as consultant for medical device manufacturers: what do our patients think?, 32 spine 2616, 2617 (2007). 73. id. at 2619. 74. licures et al., supra note 55, at 675; see also christine grady et al., the limits of disclosure: what research subjects want to know about investigator financial interests, 34 j. l. med. & ethics 592 (2006); kevin p. weinfurt et al., effects of disclosing financial interests on attitudes toward clinical research, 23 j. gen. internal med. 860 (2008). https://doi.org/10.1001/jama.2012.154 https://doi.org/10.1257/aer.101.3.423 https://doi.org/10.1056/nejmsa064160 https://doi.org/10.1097/brs.0b013e318158cc3a https://doi.org/10.1111/j.1748-720x.2006.00073.x https://doi.org/10.1007/s11606-008-0590-4 2018] financial conflicts in the new era of sunshine 83 same financial relationships the patient deems concerning. 2. physicians physicians would seem a better audience than patients for making productive use of sunshine act data. faced with public disclosure of their financial ties with industry, physicians may more carefully self-scrutinize such relationships. sunshine act disclosures could pressure physicians to decline certain questionable payments. physicians can also perform the traditional role of learned intermediary for their patients, as they are in a position to evaluate other physicians’ reported financial relationships. for example, a physician may be inclined to view more critically the favorable research results reported out of a study where the physician-investigators had publicly disclosed financial ties to the industry sponsor. as a result, the physician can change her clinical recommendations to patients about the underlying study drug or device. but it remains to be seen whether transparency really impacts physician behavior in this way. according to a market research survey conducted early in the sunshine act rollout, only 21% of physicians reported that their activities with industry had decreased. a more recent focus group study found that many75 of the participating physicians were unfamiliar with key details of the sunshine act and had only limited interactions with the open payments database. this76 disengagement may reflect the additionally expressed views of a fair number of the physicians, however accurate or not, that disclosures would mislead patients, damage physician reputations, the typical disclosed financial relationships were inconsequential, and any biased behavior involved only a small number of other clinicians and did not relate to their own practices. these responses cast doubt77 on whether many physicians are ready and willing to use the open payments database as a resource for managing financial conflicts and to discuss their financial ties to industry with patients and other stakeholders.78 also, the experience with the few state sunshine laws calls into question whether financial conflicts disclosure programs strongly influence physician behavior. a study of maine and west virginia’s sunshine laws looked at physician prescribing rates of brand name statins and selective serotonin reuptake inhibitors (ssris), two classes of drugs where pharmaceutical marketing of brand name drugs is very active and where it is suspected financial ties influence physicians to prescribe costlier, brand name drugs instead of cheaper, clinically suitable generics. but the study found almost no difference in physician79 prescribing rates in the maine and west virginia of the brand name drugs before and after each state’s disclosure law went into effect. one important caveat is80 that the west virginia and maine disclosure programs required reporting of 75. silverman, supra note 40. 76. chimonas et al., supra note 41, at 6–7. 77. id. at 8–10. 78. id. at 9–10. 79. genevieve pham-kanter et al., effect of physician payment disclosure laws on prescribing, 172 archives internal med. 819, 819–20 (2012). 80. id. at 820. https://doi.org/10.1001/archinternmed.2012.1210 84 indiana health law review [vol. 15:67 financial ties only to state regulators and the information was not made easily accessible to the public at large, unlike the open payments database. thus, it81 is unclear how generalizable the results are to the sunshine act’s broader transparency program.82 additionally, behavioral analysis suggests that disclosure may have, like patients, unintended effects on physicians. studies of advisors with financial conflicts suggest that when they have to disclose financial conflicts they may end up giving more biased advice. one possible explanation is “strategic exaggeration,” where advisors, to offset anticipated discounting of their recommendations, give more exaggerated advice. another possibility is “moral83 licensing,” where advisors may feel more emboldened to give biased advice because their advisees have been warned about the underlying financial conflict through disclosure.84 iv. revelations from sunshine act disclosures and the implications while its impact on physician and patient decision-making remains unclear and possibly confounded by unintended behavioral effects, the sunshine act still offers the most comprehensive accounting to date of the financial ties between industry and medicine. this emerging epidemiology of financial relationships is crucial to developing evidence-based regulation of financial conflicts. this section explores what has been learned so far from the sunshine act about industry-medicine financial ties and the ramifications for financial conflicts 81. chimonas et al., supra note 27, at 100. 82. a more recent study reached contrary results. the investigators examined the impact of massachusetts’ sunshine law during the time period before rollout of the federal sunshine act. they reviewed physician prescribing rates within three common drug classes: statins, antidepressants, and antipsychotics. tong guo et al., let the sun shine in: the impact of industry payment disclosure on physician prescription behavior 1, 1–2 (april 18, 2017), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2953399 [https://perma.cc/n68m-gnv3]. the study authors compared prescribing of massachusetts physicians under the state sunshine law with their counterparts in bordering counties in new york and connecticut, states without a sunshine law. id. at 2. they concluded the massachusetts sunshine law did correlate with a decline in physician prescribing in all three drug classes. id. at 2–3. however, it is again unclear how generalizable these results are to the sunshine act. see id. at 21–22. among other limitations, the investigators noted that they could not definitively conclude whether the lower prescribing rates seen in the massachusetts physicians were due to changed payment practices by industry in their dealings with massachusetts physicians, as opposed to self-monitoring by the physicians themselves, because payment data before the state sunshine law went into effect was not available. id. at 22. moreover, the use of counterpart physicians as controls in the bordering counties in different states raises questions how comparable these physicians were because of possible statespecific differences. id. at 13. 83. loewenstein et al., supra note 68, at 669. 84. id. see also sunita sah, conflicts of interest and your physician: psychological processes that cause unexpected changes in behavior, 40 j. l. med. & ethics 482, 485 (2012). https://doi.org/10.1111/j.1748-720x.2012.00680.x 2018] financial conflicts in the new era of sunshine 85 regulation. a. how common? a threshold question for regulators in addressing financial ties between industry and medicine is how commonly they occur. an oft-cited statistic, that as many as 94% of physicians have financial relationships with industry, comes from a national survey of physicians in 2003-2004 published in the new england journal of medicine. other recent surveys have estimated about 70-80% of85 physicians receive gifts from industry. 86 however, the emerging sunshine act data suggests lower prevalence rates for financial conflicts, between 40% and 50%. an analysis of data from the first five months of sunshine act disclosures suggests that about 40% of physicians received some form of payment reported into the open payments database.87 review of all of the 2015 data in the open payments database indicated about 48% of all physicians nationally received form of payment from drug companies and device manufacturers. 88 these generally lower prevalence rates (40–50%), based on analysis of open payments database records, likely have greater accuracy because of the sunshine act’s inclusion of more physicians than earlier disclosure programs and surveys. the lower prevalence rates likely also reflect changing industry practices. to avoid increased public scrutiny, manufacturers may have ended certain payments to physicians in anticipation of the sunshine act’s implementation. likewise, physicians may have started to decline transaction opportunities. nonetheless, in the 2013–2016 data in the open payments database, there is no indication of major changes year-to-year in terms of number of physicians reported or overall general payments spending, suggesting that any such blanket deterrence more89 85. eric g. campbell et al., a national survey of physician-industry relationship, 356 new eng. j. med. 1742, 1742 (2007). 86. see aaron kesselheim et al., distribution of industry payments to massachusetts physicians, 368 new eng. j. med. 2049, 2049 (2013) (citing surveys that indicate about 83% of physicians received industry gifts in 2004 and about 71% in 2009). 87. deborah c. marshall et al., disclosure of industry payments to physicians: an epidemiologic analysis of early data from the open payments program, 91 mayo clinic proc. 84, 93 (2016). 88. tringale, supra note 3, at 1774. 89. the open payments database contains only five months of reported data for 2013. as for full year comparisons, for 2014 the open payments database shows $2.68 billion in general payments, $4.07 billion in research payments, with a combined total of $6.75 billion. for 2015, there were $2.68 billion in general payments, $4.45 billion in research payments, with a combined total of $7.13 billion. for 2016, there were $2.80 billion in general payments, $4.36 billion in research payments, with a combined total of $7.16 billion. these estimates refer to payment transfers and do not include ownership or investment interests held by the physicians and teaching hospitals. see the facts on open payments, summary data, ctrs. for medicare & medicaid servs., https://openpaymentsdata.cms.gov/summary [https://perma.cc/8w6l-gl6j]. https://doi.org/10.1056/nejmsa064508 https://doi.org/10.1056/nejmp1302723 https://doi.org/10.1016/j.mayocp.2015.10.016 86 indiana health law review [vol. 15:67 likely had stronger impact in the run-up to the sunshine act data going public than afterward. still, even with the somewhat lower prevalence rates associated with the open payments database reviews, regulators still have reason for concern that patients remain widely exposed to potential financial conflicts. how often patients encounter physicians with financial conflicts does not necessarily correlate with how many physicians nationally have reported payments. physicians who accept more industry payments may care for more patients than those physicians who do not accept industry payments, or patients may more regularly visit clinicians who practice in specialties with greater industry influence. researchers estimated patient exposure to physicians with financial90 conflicts by reviewing a full year of open payments database reports, compared to a national patient sample group’s physician contacts for the same period. they found that about 65% of patients had seen a physician in the measurement period who had received a reportable general payment from industry. in other words,91 about two-thirds of patients had contact with physicians with industry payments, suggesting patient exposure to physicians under industry influence remains quite broad. b. variation by physician specialty industry-medicine financial ties have not developed uniformly between medical fields. the open payments database indicates that tremendous specialty variation exists as to prevalence of financial relationships. for example, open payments database reports for august 1, 2013 to december 31, 2013 indicate that a large number of cardiologists (78%) and gastroenterologists (68%) received some form of reportable industry payment. this contrasts with primary care92 physicians as less than half of internal medicine physicians (42%) and pediatricians (23%) had a reportable financial relationship, and a slim majority of family medicine practitioners (55%) received some form of reportable payment. lower prevalence rates were not limited to primary care fields,93 however. for the same measurement period, a small number of physicians within the fields of anesthesiology (22%), radiology (17%), and psychiatry (34%) had any form of reportable financial tie. similar trends in terms of prevalence and94 specialty variation were seen in the 2015 open payments database reports.95 apart from prevalence of financial ties, how much money flows within each financial relationship also varies tremendously between physicians in different clinical fields. according to open payments database reports for the last five months of 2013, the mean value of general payments (excluding research 90. pham-kanter, supra note 4, at 768. 91. id. at 769. 92. marshall, supra note 87, at 88. 93. id. 94. id. 95. see tringale, supra note 3, at 1774. 2018] financial conflicts in the new era of sunshine 87 payments) per surgeon ($2383) was more than twice as much as reported for physicians in general medical specialties ($976). analysis of the 2015 open96 payments database information revealed similar trends, with surgeons more likely receiving industry payments and of higher value per physician than primary care physicians.97 orthopedic surgeons are at the top in terms of lucrative financial ties with industry. for the reporting period from august 1, 2013, through december 31, 2013, the mean value of general payments per orthopedic surgeon was $7114, the highest among all physician groups, and driven largely by the high value of royalty and license payments. the mean value of general payments per98 practitioner was also relatively large in interventional specialties such as cardiology ($1866). but certain primary medical specialties attracted much99 lower overall value of payments. family medicine practitioners, pediatricians, and obstetrics and gynecology physicians, for example, had less than $500 as the mean value of general payments per physician. meanwhile, a specialty like100 neurology had relatively average rates of physicians having any form of financial relationship (49%), yet the dollar amounts attracted by those physicians were still relatively large ($2342 mean value of general payments per physician).101 thus, the open payments database has revealed considerable specialty variation across several dimensions with regard to financial relationships. in some clinical fields, like orthopedic surgery, a large number of physicians have some form of financial relationship with industry and the mean amount of general payments received by each physician is high relative to other fields. in other fields such as obstetrics/gynecology, although a large number of payments occur, the dollar value of payments is relatively small. in primary fields like pediatrics, only a smaller relative number of physicians have reportable ties to industry and the dollar amounts involved are also relatively low. because different clinical fields have interacted with industry in such divergent ways, this raises doubt about generalized regulatory rules for addressing industry-medicine financial ties. the tremendous variation of industry financial influence in different medical sectors strongly suggests that the underlying financial conflicts’ actual risks, facilitating conditions, and optimal responses, likely vary between specialties as well. at the very least, monolithic approaches for managing financial conflicts may need reevaluation. for example, transactional bans based on certain dollar thresholds or requiring second medical opinions from non-conflicted peers within the same clinical field, may be ill96. marshall et al., supra note 87, at 88. 97. tringale, supra note 3, at 1774, 1780 (finding that 61% of surgeons, compared with 47.7% of primary care physicians, were reported to have received industry payments, and that surgeons had a mean per-physician general payment value of $6879, compared to $2227 for primary care physicians). 98. marshall, supra note 87, at 90, 92–93. 99. id. at 88. 100. id. 101. id. 88 indiana health law review [vol. 15:67 fitting and overor under-inclusive with regard to how financial ties are actually developing on the ground within particular specialties. in addition, probing why such specialty variation exists can also improve financial conflicts regulation. variation in prevalence rates likely arises because of different incentives within each field to engage with industry and the accepted legitimacy within each specialty of physicians entering into financial relationships with drug companies and device manufacturers. consideration of each medical102 field’s distinct incentives and facilitating conditions for financial relationships can help guide development of regulation responsive to conditions on the ground. for example, the high degree of financial entanglement in orthopedic surgery reflects that orthopedic surgeons have historically taken the lead in product invention and development around new devices. the resulting royalty and license arrangements with device companies differs markedly from other medical fields’ interactions with pharmaceutical companies around drug development. thus,103 financial conflicts regulation may need to be more specifically tailored and modified for orthopedic surgery, such as developing new safe harbor regulations for the very large royalty and license fee relationships to minimize risk of bias but still permit valuable collaborations. 104 the variation between specialties in prevalence of financial ties also reveals industry interest in leveraging certain physician groups more than others. manufacturers will have stronger interest in wielding financial influence with physicians who are in the best position to order their drugs and devices and these clinicians tend to work in more interventional fields. the sunshine act data reveals that, roughly, and with some exceptions, medical specialties at the higher end of the interventionist spectrum, such as cardiology, neurosurgery, and gastroenterology, have higher prevalence rates of clinicians receiving any form of industry payment than the low intervention fields such as pediatrics and internal medicine. this information can help guide regulators develop targeted105 audits and educational efforts within certain specialty fields to facilitate more efficient enforcement of the anti-kickback statute, false claims act,106 107 physician self-referral law (aka “stark law”), and other healthcare fraud and108 abuse laws that may be triggered by the industry-medicine financial relationships. 102. kesselheim et al., supra note 86, at 2051. 103. see, gregory l. cvetanovich et al., industry financial relationships in orthopaedic surgery: analysis of the sunshine act open payments database and comparison with other s u r g i c a l s p e c i a l t i e s , 9 7 j . b o n e j o i n t s u r g e r y 1 2 8 8 ( 2 0 1 5 ) , https://www.ncbi.nlm.nih.gov/pubmed/26246264 [https://perma.cc/y6ty-49dl]. 104. id. 105. marshall, supra note 87, at 88 (noting that one exception to this trend, for example, is plastic surgery, a high interventionist field where the prevalence rate (37%) of physicians having any form of reported financial ties is relatively low). 106. 42 u.s.c. § 1320a-7b (2015). 107. 31 u.s.c. §§ 3729-3733 (2009). 108. 42 u.s.c. § 1395nn (2010). https://doi.org/10.2106/jbjs.n.01093 2018] financial conflicts in the new era of sunshine 89 c. variation by physician gender gender matters according to the sunshine act data. similar to physician specialty, physician gender correlates with different frequency and dollar value of financial ties with industry. analysis of 2015 reports in the open payments database indicated that among physicians nationally, 51% of male physicians but only 42.7% of female physicians had a reportable financial relationship with industry. female physicians nationally also had a lower mean value of general109 payments per physician than their male peers ($1309 compared to $5031).110 these trends for physicians overall also carried over to distinct medical specialties, as within most medical fields male physicians were more likely to receive general payments from industry, and their mean per-physician payments were higher. these results are consistent with earlier analyses. for example,111 analysis of 2013 open payments database reports revealed that of the 300 doctors who received the most money for speaking and consulting payments, 90% were male. similarly, among reported general payments to oncologists,112 male physicians were more likely to receive industry payments and in greater amounts than female physicians. 113 the gender disparity in overall general payments likely arises for several reasons. royalty and license payments can significantly increase the overall dollar value of payments flowing to individual physicians. but female114 physicians remain underrepresented in product invention and development and may therefore have less interactions with device companies and drug manufacturers. others speculate that female physicians tend to desire more115 patient-oriented care and may have different preferences than male physicians regarding dealing with industry. it may also be that because male physicians116 tend to earn higher compensation in the medical labor market, industry needs117 to offer more, in terms of dollar value, to attract the attention of male physicians 109. tringale, supra note 3, at 1777. 110. id. at 1779. 111. id. at 1779, 1783. 112. charles ornstein, men dominate list of doctors receiving largest payments from drug companies, n.y. times (oct. 9, 2014), https://www.nytimes.com/2014/10/09/upshot/mendominate-list-of-doctors-receiving-largest-payments-from-drug-companies.html [https://perma.cc/ez66-m2c2]. 113. deborah c. marshall et al., distribution and patterns of industry-related payments to oncologists in 2014, 108 j. nat’l cancer inst. 1, 4, 9 (2016), https://academic.oup.com/jnci/ art icle-abstract/108/12/djw163/2706926/distr ibution-and-patterns-of-industryrelated?redirectedfrom=fulltext [https://perma.cc/3vgx-248g]. 114. tringale, supra note 3, at 1781. 115. marshall, supra note 113. 116. tringale, supra note 3, at 1781. 117. catherine saint louis, dr. paid-less: an old title still fits female physicians, n.y. times (july 11, 2016), https://www.nytimes.com/2016/07/12/health/women-doctors-salaries-paygap.html [https://perma.cc/7lhw-k4d4]. https://doi.org/10.1093/jnci/djw163 90 indiana health law review [vol. 15:67 when initiating financial relationships. moreover, the gender disparity may be self-reinforcing, as industry may prefer to target influential opinion leaders and manufacturers may view more male physicians belonging in this group precisely because of the male physicians’ greater likelihood of having previous deals with manufacturers.118 the gender disparity data also has interesting ramifications for regulation and policy. because gender is a predictor, among other factors, for potential financial conflicts, regulators might consider physician gender in developing targeted educational efforts and monitoring plans for compliance under the health care fraud and abuse laws. moreover, the incentives female physicians face for less financial relationships with industry might be further studied and replicated on a broader scale to counter aggressive industry influence. meanwhile, some commentators hope that the sunshine act’s transparency about gender disparity will end up reducing gender differences. under this view, increased visibility119 of how industry payments to physicians differ by gender could lead to greater questioning of manufacturers’ business practices generally, pressuring companies to adopt more gender-neutral payment practices in interacting with medicine.120 any such impact of the sunshine act, however, remains to be seen. d. skewed distribution: small number of physicians attracting most dollars the emerging sunshine act data has also revealed interesting patterns in the distribution of payments within a medical specialty. among physicians within a particular medical field who do receive payments, the financial amounts involved are not relatively uniform. instead, payment distribution is heavily skewed toward a small number of physicians who are top earners. for example, among orthopedic surgeons, a very small number of practitioners attract the lion share of payments in terms of dollar value. open payments database reports indicates that only about 2% of orthopedic surgeons receive royalty and license payments from industry. but the aggregate dollar value of these payments is quite large, accounting for 70% of the total value of monetary payments received by all orthopedic surgeons.121 similar skewed payment distribution patterns, with large dollar amounts flowing toward a few top-earners, have been observed in several other specialties. according to early sunshine act data, the top ten percent of otolaryngologists, ranked by the dollar value of industry payments they each receive, account for 87% of all the industry payments to their specialty field as a whole. industry122 118. id. 119. susannah l. rose et al. gender differences in physicians’ financial ties to industry: a study of national disclosure, plos one 1, 8 (june 11, 2015), http://journals.plos.org/plosone/ article?id=10.1371/journal.pone.0129197 [https://perma.cc/7ub4-mm85]. 120. id. 121. cvetanovich, supra note 103, at 1293–94. 122. vinay rathi et al., industry ties in otolaryngology: initial insights from the physician payment sunshine act, 152 otolaryngology-head & neck surgery 993 (2015) https://doi.org/10.1371/journal.pone.0129197 https://doi.org/10.1177/0194599815573718 2018] financial conflicts in the new era of sunshine 91 payments to obstetrics-gynecologists likewise seem skewed to a small number of top earners. orthopedic surgery and neurosurgery have the greatest payment123 distribution disparity (in terms of overall dollar value flowing to each physician) between practitioners in their disciplines. however, not all medical fields have this very high degree of skewed payment distribution. primary care fields like internal medicine and family medicine are not as heavily skewed in payment distribution.124 the skewed payment distribution patterns can be interpreted in different ways. a more benign explanation is that manufacturers target the few respected opinion leaders within each field based on academic credentials and general reputation, hoping to tap their expertise and standing in the field in a variety of legitimate collaborations, such as consulting on product development. in addition, royalty and license fees often comprise the large dollar payments to the top few earners. it should not surprise that only a few physicians in each field are able to earn such fees as successful innovators because of the long, arduous process for taking products from the invention stage to regulatory approval and regular clinical use. a more troubling explanation, however, is that this represents industry attempts to heavily leverage a few physicians through very lucrative relationships, and rely upon those physicians to influence their peers’ prescribing and referral choices, which may be a more cost-effective way of driving physician prescribing in the aggregate than more equal distribution of payments. further, the skewed payment distribution patterns have implications for regulation and policy. in clinical fields where heavily skewed payment distributions occur, regulators might consider taking action specifically directed at the top dollar physician recipients as their financial ties may warrant more finetuned responses. this could include concentrated audit and enforcement actions and prophylactic monitoring of the top dollar physician recipients’ prescribing. regulators might also consider looking at the underlying payment categories driving the skewed payment distributions and consider whether additional rules are needed. for example, royalty and license payments appear to contribute significantly to the skewed distribution patterns. additional safe harbor regulations might be considered to minimize risk of bias and undue influence within royalty and license arrangements. as an illustration, surgeons might be required to contribute more than just surgical volume with a device in order to be considered part of the device’s design team and be eligible for sharing in royalty http://journals.sagepub.com/doi/pdf/10.1177/0194599815573718 [https://perma.cc/z8e7-255h]. 123. see nicole tierney et al., industry payments to obstetrician-gynecologists, 127 obstetrics & gynecology 376, 379 (2016), http://journals.lww.com/greenjournal/ abstract/2016/02000/industry_payments_to_obstetrician_gynecologists_.28.aspx [https://perma.cc/pya9-hef8]. 124. andre samuel et al., orthopedic surgeons receive the most industry payments to physicians but large disparities are seen in sunshine act data, 47 clinical orthopaedics & related res. 3287, 3301 fig. 3 (2015), https://www.ncbi.nlm.nih.gov/pubmed/26088767 [https://perma.cc/hw5b-jyg9]. https://doi.org/10.1097/aog.0000000000001270 https://doi.org/10.1007/s11999-015-4413-8 92 indiana health law review [vol. 15:67 and license payments from the product’s commercialization.125 v. what still needs to be known while the sunshine act is building up the evidence base in some key respects, a great deal remains unknown, even in this new era of sunshine, about financial conflicts regulation. this section considers several significant areas where the lack of firm evidence continues to complicate and undermine development and enforcement of optimal laws and policies. a. correlation vs. causation: the actual causal impact of financial conflicts the sunshine act has made more transparent the pervasiveness and wide variety of industry-medicine financial relationships. but whether these financial ties directly create harm, and to what extent, remains far less certain. limited data exists concerning the effects of financial conflicts in health care decision-making generally and it remains subject to conflicting interpretation. opponents of126 heightened regulation charge that proof is still lacking that financial ties sway physicians’ prescribing and referral decisions in ways that actually harm patients therapeutically. for example, while financial ties have been correlated with127 more expensive drug prescribing, this does not mean patients are receiving128 clinically inappropriate treatments. standards of care are rarely uniform; wide variations exist in the way clinicians practice medicine. many prescribing129 decisions are made where there is no one clear treatment pathway and reasonable clinicians may have different preferences, all within various accepted schools of thought. thus, “it is often quite difficult to assess whether advice is biased or not, even in the presence of a conflict of interest.” the knowledge gap about the130 125. cf. richard h. gelberman, orthopedic surgeons and the medical device industry: the threat to scientific integrity and the public trust, 92 j. bone & joint surgery 765, 773 (2010), http://journals.lww.com/jbjsjournal/citation/2010/03000/orthopaedic_surgeons_and_the_medi cal_device.30.aspx [https://perma.cc/wg9t-xrxf]. 126. compare christopher robertson et al., effects of financial relationships on the behaviors of health care professionals: a review of the evidence, 40 j. l. med. & ethics 452 (2012), with teddy d. warner & john p. gluck, what do we really know about conflicts of interest in biomedical research?, 171 psychopharmacology 36 (2003). see also ronald bailey, scrutinizing industry funded science: the crusade against conflicts of interest (american council on science & health, 2008). 127. see, e.g., d. barton et al., after 20 years, industry critics bury skeptics, despite empirical vacuum, 68 int’l j. clinical prac. 666, 666 (2014). 128. see infra notes 141–46 and accompanying text. 129. see, e.g., john e. wennberg, variation in use of medicare services among regions and selected academic medical centers: is more better?, commonwealth fund pub. no. 874 (2005); james f. blumstein, medical malpractice standard-setting: developing malpractice “safe harbors” as a new role for qios?, 59 vand. l. rev. 1017, 1026–27 (2006); mark a. hall et al., health care law and ethics 322 (8th ed. 2013). 130. sunita sah et al., effect of physician disclosure of specialty bias on patient trust and https://doi.org/10.2106/jbjs.i.01164 https://doi.org/10.1111/j.1748-720x.2012.00678.x https://doi.org/10.1007/s00213-003-1657-x https://doi.org/10.1111/ijcp.12438 https://doi.org/10.1073/pnas.1604908113 2018] financial conflicts in the new era of sunshine 93 true impact of industry-medicine financial ties is particularly acute regarding medical research. financial relationships between industry and investigators, while correlated with possible publication bias, have not been linked to increased rates of adverse events for subjects participating in clinical trials. 131 debate over the true impact of financial conflicts boils down to correlation versus causation. much of the empirical data about financial interests is based on observational rather than conventional studies. the studies typically report132 association between financial ties and problematic research behavior, as opposed to causal evidence. many serious risks are associated with financial conflicts,133 including harming patients, increasing costs, limiting choice, and biasing research. but for all these supposed risks, virtually none have been causally134 linked to underlying financial conflicts through comprehensive studies employing gold standard proof and rigorous statistical techniques, such as randomization and use of controls. as opponents of stricter regulation often highlight, any number of confounding variables may be responsible for associations between financial ties and certain problematic conduct. moreover, design limitations make135 determining the effects of financial conflicts difficult. for example, observed associations may be false negatives arising from the often-small sample sizes.136 meanwhile, multiple possible sources of causation raise contamination problems. comparison physicians, thought to be unexposed to financial ties, may be treatment choice, 113 pnas 7465, 7467 (2016). 131. thomas p. stossel, regulating academic-industrial research relationships–solving problems or stifling progress?, 353 new eng. j. med. 1060, 1061 (2005). 132. see, e.g., josephine johnston, financial conflicts of interest in biomedical research, in trust & integrity in biomedical research 11, 16–17 (thomas h. murray & josephine johnston, eds., 2010) (noting that as even the institute of medicine’s 2009 conflict of interest report concedes, “on many topics related to conflicts of interest, no systematic studies are available…[while] for other topics, data are suggestive rather than definitive.”). iom conflict of interest report, supra note 1, at 4. 133. see, e.g., stanford c. taylor et al., physician-industry interactions and anti-vascular growth factor use among us ophthalmologists, 134 jama opthamology 897, 897 (2016) (“[t]his analysis cannot determine whether the payments reported caused the increased use, are a result of the increased use, or are merely associated with some other factor that causes the increased use.”). 134. iom conflict of interest report, supra note 1, at 23, 27. 135. see, e.g., barton supra note 127, at 671 (“[a] 1998 study found that authors with financial ties to drug manufacturers were more likely to endorse the use of calcium channel blockers, which some believed to be unsafe, than those without such ties. this was interpreted as a case where financial ties caused physicians to endorse a product they otherwise might not have. yet, the association is confounded since these authors’ views could also be explained by their greater seniority, prominence and experience.”). 136. see geoffrey k. spurling et al., information from pharmaceutical companies and the quality, quantity, and cost of physicians’ prescribing: a systematic review, 7 plos med. 1, 17 (2010), http://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed. 1000352&type=printable [https://perma.cc/d4bt-gv32]. https://doi.org/10.1056/nejmsb051758 https://doi.org/10.1001/jamaophthalmol.2016.1678 https://doi.org/10.1371/journal.pmed.1000352 94 indiana health law review [vol. 15:67 influenced by their peers who do transact with industry, while physicians with financial ties may nonetheless be more strongly influenced by non-financial sources. further, some correlations may reflect bidirectional causation, as137 physicians who prescribe in larger volume or more expensively may in turn willingly expose themselves to more promotional activities and industry influence. 138 the sunshine act has moved the ball in some respects. the information generated offers even stronger evidence of correlation and in a wide variety of contexts. publicly available databases detail the medicare-reimbursable services provided by individual physicians and the prescription drugs ordered by139 individual physicians under the medicare part d prescription drug program.140 thus, it is now theoretically feasible to compare industry spending directed at an individual physician within the open payments database and the prescribing and referral decisions of that same physician for medicare patients within these latter databases. a first wave of studies making such comparisons has been published, with interesting conclusions about correlation. 141 one noteworthy investigation, looking at 12 different medical specialties, indicated that physician receipt of industry payments was associated with greater prescribing costs per medicare patient and greater likelihood of the physician prescribing more costly brand name medications instead of cheaper generics.142 the study authors noted that this association persisted across all the medical specialties examined, except for general surgery, even though there was wide variation between most of the medical specialties in the distribution and amount of industry payments. the study authors further noted that in some specialties143 the cost increases largely arose due to the physicians’ more expensive prescribing overall, whereas in other specialties the cost increases were driven largely by the 137. id. 138. id. 139. medicare provider and utilization and payment data: physician and other supplier, ctrs. for medicare & medicaid servs., https://www.cms.gov/research-statistics-data-andsystems/statistics-trends-and-reports/medicare-provider-charge-data/physician-and-othersupplier.html (last modified june 15, 2017) [https://perma.cc/fl62-vvzc]. 140. medicare provider and utilization and payment data: part d prescriber, ctrs. for medicare & medicaid servs., https://www.cms.gov/research-statistics-data-andsystems/statistics-trends-and-reports/medicare-provider-charge-data/part-d-prescriber.html (last modified may 25, 2017) [https://perma.cc/x3uf-klvy]. 141. see, e g., william fleischman et al., association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study, 354 bmj 1, 4–5 (2016); taylor, supra note 133, at 899–902; dejong, supra note 50, at 1114. 142. roy h. perlis & clifford s. perlis, physician payments from industry are associated with greater medicare part d prescribing costs, plos one, 1, 1 (may 16, 2016), http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0155474&type=printable [https://perma.cc/4teu-b9q9]. 143. id. at 6. https://doi.org/10.1136/bmj.i4189 https://doi.org/10.1371/journal.pone.0155474 2018] financial conflicts in the new era of sunshine 95 physicians prescribing brand-name drugs over generics. 144 another such study found correlation between physician prescribing and mere receipt of meals. the investigators looked at physicians who received reported food payments from industry and their prescriptions to medicare patients for statins, angiotensin receptor blockers, cardioselective beta-blockers, and selective serotonin reuptake inhibitors. the researchers found a significant145 association between a physician receiving a single meal and higher rates of prescribing the costlier brand name medication connected to the promotional meal. this association persisted even though for the class of drugs studied there was no strong evidence that the brand name medications were any better than cheaper generic equivalents.146 the sunshine act has even led to correlation studies concerning physicians’ use of social media. one recent investigation, using open payments database reports, found that more than 70% of cancer doctors with active twitter accounts received payments from industry unrelated to research or grants. these ties147 were ordinarily not disclosed on their twitter accounts. in some instances, the physicians might have been tweeting reviews about particular medications or clinical trials involving products made by manufacturers making payments to the physicians.148 however, as intriguing as these studies utilizing open payments database information may be, they still only show correlation, not causation. for example, with the dejong meal study, the physicians who accepted the industry meals may have already developed a preference for the brand name medications, for reasons unrelated to industry payments, and so they were more likely to attend promotion meals sponsored by the brand name manufacturers than other physicians.149 under this interpretation, it is still debatable whether the financial relationships directly swayed physician prescribing. unfortunately, it is unlikely that the emerging sunshine act data will ever be able to resolve definitively the enduring uncertainty about financial conflicts and causation. financial conflicts of interest, risk of bias, and undue influence operate in a complex and ultimately murky environment with many levers and moving parts. confounding factors include: the widely different types of financial transactions that arise; industry-medicine financial relationships also have nonfinancial dimensions; the supposed biasing effect of financial ties involves hard to measure psychological pressures and unconscious decision-making; difficulty in isolating the effect of particular financial ties on individual physicians from the impact of larger financial relationships industry may form with institutions where 144. id. at 7. 145. dejong, supra note 50, at 1114. 146. id. 147. derrick l. tao et al., financial conflicts of interest among hematologists-oncologists on twitter, 177 jama internal med. 425, 426 (2017). 148. alexandra sifferlin, what your doctor isn’t telling you on twitter, time (jan. 17, 2017), http://time.com/4634502/twitter-cancer-doctors/ [https://perma.cc/tbm7-vbw8]. 149. dejong, supra note 50, at 1121. https://doi.org/10.1001/jamainternmed.2016.8467 96 indiana health law review [vol. 15:67 the physicians practice; and physician behaviors can change over measurement periods for reasons unrelated to industry’s financial influence, such as malpractice liability concerns, new institutional policies, and reimbursement changes from payers. moreover, it is nearly impossible to design rigorous randomized trials with controls to study causation when investigating financial relationships already occurring, leaving much of the analysis to observational studies that inevitably can be challenged as not firm enough proof. it should be noted that evidence of correlation, even if not causation, may still be enough to warrant stronger regulatory responses. for one, financial relationships may reinforce problematic prescribing patterns through association, even if not initially causing those prescribing choices. moreover, the risk of150 harm from certain financial relationships may be of such concern that, because of risk mitigation and the “precautionary principle,” it may be better to regulate151 prophylactically even where evidence of causation is still lacking. the dangers of inaction may be so great that it is unwise to wait for definitive causation evidence to arrive, if it ever does. further, as robert steinbrook has argued, it may not be necessary to prove a causal relationship between industry-medicine financial ties and changes in physician behavior. associations between industry payments and physician prescribing of more expensive brand name medications are troubling enough because of the perceptions created of industry influence.152 also, even in the absence of causation evidence, physicians have a professional obligation to consider how these relationships with industry affect the costs imposed on patients.153 nonetheless, the lack of firm causation evidence remains a serious challenge. it calls into question the proportionality and ultimate justification for much financial conflicts regulation. this makes it all the harder to obtain political consensus on the best policy options, including all-important buy-in from more entrepreneurial physicians. perceptions that financial conflicts regulation inequitably burdens physicians who collaborate with industry can encourage cynicism, disregard, and noncompliance, making it much harder to implement and enforce rules addressing financial conflicts. 154 b. choosing between regulatory options transparency alone clearly is insufficient to address health care financial conflicts. knowing this, then what? which regulatory options, beyond 150. lo, supra note 45, at 1720. 151. daniel goldberg, on physician-industry relationships and unreasonable standards of proof for harm: a population-level bioethics approach, 26 kennedy inst. ethics j. 173, 175 (2016). 152. robert steinbrook, physicians, industry payments for food and beverages, and drug prescribing, 317 jama 1753, 1753–54 (2017). 153. id. 154. richard s. saver, shadows amid sunshine: regulating financial conflicts in research, 145 chest 379, 383 (2014). https://doi.org/10.1353/ken.2016.0022 https://doi.org/10.1001/jama.2017.2477 https://doi.org/10.1378/chest.13-1719 2018] financial conflicts in the new era of sunshine 97 disclosure, should also be deployed? non-disclosure regulatory alternatives include supplying alternative sources of information to guide health care decision-making, such as mandatory second opinions from independent physicians about recommended treatment and research. similarly, governmental and institutional policies can support academic detailing programs. academic detailing provides neutral expert physician advice to community physicians about particular treatment options, and employs similar persuasion techniques used by pharmaceutical companies to counter industry’s marketing efforts. regulation155 can also impose outright prohibitions, such as transactional bans of financial ties of certain dollar amounts or within certain payment categories (e.g., banning speaker fees) or barring physicians with apparent financial conflicts from rendering certain services such as serving on clinical practice guideline committees or conducting primary research. regulation can also address industry influence by substituting certain industry roles with governmental action. for example, commentators have urged minimizing financial conflicts in research by requiring that independent entities, overseen by government agencies, entirely take over the design and conduct of clinical trials. 156 unfortunately, almost none of these approaches has been implemented in a way to accrue significant data. the dearth of information arises because much conflict of interest regulation, whether through law or institutional policies, has developed ad hoc in response to particular crises. as lisa rosenbaum observes, “conflict of interest policies have evolved not through careful data gathering and analysis but through intensification of regulations after each big scandal.”157 accordingly, questions arise whether particular regulatory options work well in the broad range of situations contemplated. further, like mandated disclosure, will some of these alternatives have unintended effects and introduce new problems? for example, requiring patients to seek a second medical opinion from a physician who has no financial relationship seems, at first impression, a promising way to counter potential bias of conflicted physicians. but behavioral studies suggest that professional advisors with a conflict, aware that their clients will have access to a second opinion, are more likely to give more biased recommendations. therefore, a required second opinion policy could be158 155. see generally jerry avorn, academic detailing: marketing the best evidence to clinicians, 317 jama 361 (2017) (detailing a discussion of academic detailing modeled on the very successful practices adopted by pharmaceutical companies to create physician interest in their firms' drugs, such as the use of physician peer educators and face-to-face discussions with physicians by drug company sales representatives. academic detailing involves one-on-one or small group visits between the targeted physicians and an expert physician spokesperson). 156. see marc a. rodwin, independent drug testing to ensure drug safety and efficacy, 18 j. health care l. & pol’y 45, 77–81 (2015). 157. lisa rosenbaum, beyond moral outrage—weighing the trade-offs of coi regulation, 372 new eng. j. med. 2064, 2065 (2015). 158. sah, supra note 130, at 7465; see also sunita sah & george loewenstein, conflicted advice and second opinions: benefits but unintended consequences, 130 organizational behav. & hum. decision process 89, 89 (2015). https://doi.org/10.1001/jama.2016.16036 https://doi.org/10.1056/nejmms1502498 https://doi.org/10.1016/j.obhdp.2015.06.005 98 indiana health law review [vol. 15:67 counterproductive, increasing the degree of biased advice that patients receive from their primary physicians with financial conflicts. perhaps most vexing, comparative effectiveness data about the possible regulatory responses is sorely lacking. even if interested in moving beyond transparency, policymakers lack a foundation to understand how to choose between the regulatory alternatives, as some may be more effective than others in differing contexts. also lacking is comparative effectiveness data on whether transparency combined with one or more additional regulatory approaches is ultimately more effective than one of the alternatives alone. heavy reliance on any one regulatory approach is unwise, because industry-medicine financial relationships are so pervasive, varied, and complex. each regulatory alternative159 may work through different channels and levers, with particular advantages that can be combined to address more comprehensively the underlying risks posed by financial conflicts. however, finding the right regulatory mix remains uncertain. in optimally choosing between regulatory alternatives, it also remains important, but unfortunately difficult, to account properly for the costs of potential over-deterrence. for example, transactional bans limiting industrymedicine financial relationships of certain types or amounts, or barring physicians with financial ties from rendering certain opinions and services, may seem cleaner and more direct than regulation through transparency. but such aggressive approaches could also lead to slower development of important therapies and the lack of needed expertise in development of clinical practice guidelines or even publication of important study results. these lost benefits often are less visible and salient than the risks of potential bias arising from financial conflicts. as lisa rosenbaum writes in the new england journal of medicine: the invisibility of potential benefits makes rationally weighing the tradeoffs we make with conflict of interest policies even harder. when we miss an appendicitis diagnosis, we usually find out that we’ve erred. when we prevent the dissemination of expertise, thwart productive collaborations, or dissuade patients from taking effective drugs, we get no such feedback. meanwhile, we’re incessantly reminded of the socalled risks [of financial conflicts]. . . .160 thus, choosing between regulatory options in moving beyond transparency remains fraught with uncertainty and possible counterproductive effects. c. if disclosure, how to do it effectively? even if policymakers continue to look to transparency as an important, if not by itself sufficient, regulatory tool for addressing financial conflicts, much still remains uncertain about the optimal way to go about disclosing. thorny logistical issues and many possible pitfalls arise in deciding the process and format for 159. stead, supra note 48, at 1765. 160. rosenbaum, supra note 157, at 2065. 2018] financial conflicts in the new era of sunshine 99 disclosing information about a topic as complex and multifaceted as industrymedicine financial ties. primary audiences may not know what to make of the disclosed financial conflict, have considerable uncertainty about how it actually affects their care, become overwhelmed by too much disclosure, or simply ignore the information. unfortunately, there have been few studies of the relative161 effectiveness of different ways to disclose financial conflicts. indeed, “given the importance of this issue for u.s. health care, it is striking how little evidence exists to guide policies or interventions.” 162 as previously discussed, the open payments database has clear limitations, notably the lack of important comparative and contextual information. however, adding detailed comparative and contextual information threatens to burden and confuse end users with too much complexity. a significant unknown, and where more research is sorely needed, is determining the hard to find sweet spot between financial conflicts disclosure that is engaging, accessible, and understandable but also accurate and sufficiently detailed. moreover, the optimal disclosure method and parties that should be involved also remain unclear. is transparency best done through a publicly accessible, searchable database, such as the open payments database? or by requiring providers to make their conflicts disclosures directly to patient, payers, and other stakeholders? as previously noted, the open payments database may not match patient preferences for how to learn about financial conflicts. focus group research suggest patients prefer a live discussion of the conflict with their physicians during an office visit oriented around the treatment for which the financial relationship is relevant. direct disclosure of this type may be163 preferable because it best facilitates a dialogue, immediately responsive to the disclosure, between the patient and the provider about the financial conflict where the patient can ascertain more personally relevant information about the conflict’s possible implications. also, having physicians more actively involved in164 initiating financial conflict disclosure makes the process more automatic, with patients as regular recipients of the information even when they do not ask about it. would requiring that providers directly disclose their conflicts to patients therefore be better? not necessarily. removing physicians directly from the disclosure process, as the sunshine act does, helps minimize concerns suggested by behavioral research that the act of disclosing can lead advisors like physicians to give more biased advice. also, physicians are unlikely to have as accurate165 information about their financial ties as the manufacturers. many physicians typically have a wide variety of financial relationships that arise with multiple 161. katrina armstrong et al., challenges and opportunities in disclosing financial ties to patients, 317 jama 1743, 1743–44 (2017). ian larkin & george loewenstein, business modelrelated conflicts of interest in medicine, 317 jama 1745, 1746 (2017). 162. armstrong, supra note 161, at 1744 163. oaks, supra note 66, at 40–41 164. armstrong, supra note 161, at 1744. 165. see supra notes 83 to 84 and accompanying text. https://doi.org/10.1001/jama.2017.2656 https://doi.org/10.1001/jama.2017.2275 100 indiana health law review [vol. 15:67 drug and device firms in everyday medical practice, including receipt of small items such as food, making it difficult to keep track of all the transactions. further, removing physicians from having to make the direct disclosures also eases the regulatory burden on already time-pressed physicians and may be a more politically palatable way of ensuring some form of transparency. in theory, decision aids could make the disclosure process more effective.166 for one, decision aids could educate patients about the risk of bias arising even in small dollar transactions with industry and also the prevalence of financial ties. but their content, and how they would best be used, is still the subject of167 much speculation given the limited experience with using decision aids for financial conflicts disclosures. some commentators suggest that financial conflicts disclosure might work better if patients were generally educated about industry-medicine financial relationships well before they consider a particular treatment choice, such as during the time of enrollment with their health plans.168 again, however, given the dearth of studies, whether this would actually improve the disclosure process is mostly speculation. d. what do patients really think? while patients may ultimately not be the best audience for financial conflicts disclosure, for reasons previously discussed, accounting for their views remains169 important to designing responsive regulation as part of a patient-centered health care system. unfortunately, what patients really think about financial conflicts170 remains muddled. for example, as earlier noted, research indicates that most patients want to know whether their physician has financial ties with industry, but far fewer indicate that it would materially change their decision-making. what171 should be concluded from this? are these seemingly divergent views—wanting to know the information, but saying it would likely not sway their decision—irrational? understandable? one view is that such patients may respond, “the more information the better,” under a vague right-to-know imperative, even if they are not materially bothered by learning about physicians with financial ties. such patients may correctly perceive that other constraints, such as reimbursement rules, professional norms, and tort liability, already limit the likelihood that their physicians will provide flawed, biased advice and treatment. also, patients may be unbothered and even blasé about industry-medicine financial ties because they remain well aware of financial conflicts arising elsewhere in medicine and 166. sah, supra note 130, at 7468. 167. cf. chimonas, supra note 41, at 10. 168. armstrong, supra note 161, at 1744. 169. see supra notes 60–74 and accompanying text. 170. cf. inst. of med., crossing the quality chasm: a new health system for the 21st century 48 (2001); joan h. krause, can health law truly become patient centered?, 45 wake forest l. rev. 1489, 1489–90 (2010). 171. see supra notes 71 to 74 and accompanying text. 2018] financial conflicts in the new era of sunshine 101 perceive such conflicts as ingrained. many patients recognize that, despite the lofty ideal of a physician with undivided loyalty to the patient, a physician can earn more depending on the type and volume of services recommended. under the traditional fee-for-service reimbursement model, a physician faces financial conflicts—the more severe and long-lasting the illness, the more complex services a physician can provide, and the higher fees earned. thus, risk of bias172 arising in financial ties with industry may seem, to many patients, to simply be more of the same. a more troubling consideration is that many patients have general awareness of industry-medicine financial relationships but underestimate how this may affect their own health care. even with increased sunshine, patients may not know what to make of the disclosed information and how it may affect them, therapeutically and financially. disregard is especially likely because, as previously discussed, only certain contextual factors, such as payment amount and payment category, may be salient to patients and not the many other conditions that can increase risk of bias. also, disclosing the data on financial173 relationships simply may lead to more questions with no good answers. as abigail zuger observes, “[t]he meaning behind the numbers still remains elusive. are lavishly compensated physicians just shrills for the pharmaceutical industry? or are they simply well-paid advisers…? [h]ow can patients be expected to decide?”174 it is tempting to assume that because of extensive news coverage of problematic industry-medicine relationships and the rollout of the sunshine act patients are at least primed to consider possible financial conflicts in their own health care decision-making. but a recent national patient survey indicated that 45% of the patients were generally aware of industry payments to physicians, but only 12% knew that this information was publicly available through programs like the sunshine act. moreover, only five percent of the patients reported175 knowing whether their own physician had received industry payments. even176 worse, among patients who believed that their physician did not receive an industry payment, a review of the open payments database revealed that 41% were incorrect. thus, a fair number of patients may mistakenly assume that177 financial ties to industry do not impact their own personal health care. another possible explanation for the seemingly divergent patient responses is the stickiness of the doctor-patient relationship. many patients, even if concerned about a disclosed financial conflict, likely find it difficult to contemplate terminating their relationships with their physicians. for the mysterious therapeutic healing process to activate in the doctor-patient relationship, the patient ordinarily must have a certain level of trust and even 172. zuger, supra note 6, at 1747. 173. see supra notes 47 to 56 and accompanying text. 174. zuger, supra note 6, at 1748. 175. pham-kanter, supra note 4. 176. id. 177. id. 102 indiana health law review [vol. 15:67 uncritical faith in the physician. a financial conflicts disclosure may not be178 enough to jeopardize that trust and motivate the patient to seek treatment elsewhere. indeed, a patient may be less tolerant of financial conflicts generally179 than for her own physician because the personal connection formed with the physician, and the special investment in the treatment relationship, may outweigh more abstract concerns about financial conflicts. another reason for stickiness180 in the doctor-patient relationship is patient realization that search costs and insurance coverage constraints may make it hard to change physicians anyway. unfortunately, while these explanations of patients’ seemingly divergent views seem plausible, they also are highly speculative. we just do not know enough at present about the full scope of patient expectations and attitudes about industry-medicine financial relationships. further research is needed to get a better handle on what patients really think about financial conflicts and why. e. role of conflict of interest committees an important but underappreciated entity in the regulatory space concerning financial conflicts is the institutional conflict of interest committee (coic). coics exist at most major medical centers and health systems. usually established pursuant to internal institutional policies, they are comprised of a mix of physician and medical center administrative staff. certain financial181 relationships between the medical center, staff physicians, and industry will be referred to and reviewed by the coic. these committees can act as proxies for patients and research subjects, and in theory, can better assess and interpret the relevant conflicts disclosures. apart from internal institutional policies, federal research regulations also contemplate an active role for coics in monitoring financial conflicts. for example, the nih regulations require that nih grantees disclose to their institutions “significant financial interests,” such as consulting payments or182 equity interests that relate to their research-related activities. the institution183 must then evaluate the disclosed financial relationship and report to the public health service any interests identified as conflicting and the institution’s 178. see generally mark a. hall, law, medicine, and trust, 55 stan. l. rev. 463 (2002). 179. genevieve pham-kanter, act ii of the sunshine act, plos med. (nov. 4, 2014), http://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1001754&type=printable [https://perma.cc/t6cb-mvxx]. 180. zuger, supra note 6, at 1748. 181. see, e.g., northwestern university conflict of interest committee oversight guidelines, nw . u. (oct . 20 , 2014) , h t tp : / /www.nor thwestern .edu /coi/commit tees / coioc_final_guidelines_final.pdf [https://perma.cc/4g3n-5klj]; see also conflict of interest (coi), u. mich. res. ethics & compliance, http://research-compliance.umich.edu/conflictinterest-coi [https://perma.cc/h6ln-5whe] (last visited sept. 9, 2017). 182. 42 c.f.r. § 50.604(e). 183. 42 c.f.r. § 50.603. https://doi.org/10.1371/journal.pmed.1001754 2018] financial conflicts in the new era of sunshine 103 management plan for dealing with the conflict. coics usually perform this184 important required review at the institutional level for financial relationships that trigger the nih reporting requirement. in coming up with management plans, coics have tremendous discretion to impose safeguards that they feel adequately address a financial relationship they have identified as conflicting. for example, coics can choose to require the investigator to disclose the conflict in all published studies resulting from the research, move the research to another site, or ban the conflicted investigator from directly enrolling subjects for the research. similarly, guidance from the department of health and human185 services (hhs) urges medical centers where hhs funded research is conducted to make distinct use of their own coics to monitor and address recurring issues of financial conflict of interest for both the investigators doing the clinical trial work and for the institutions as a whole.186 thus, as the sunshine act generates information about industry-medicine financial ties, more questions about specific financial relationships uncovered can be expected to be referred to coics at the applicable institutions. coics will play a critical role on the ground in how most institutions respond to and manage newly identified financial ties that have been revealed through greater transparency. but there is a striking dearth of information about the institutional capacity of coics to perform this role and the best practices that they should follow. indeed,“[d]espite . . . federal regulation and substantial debate over the appropriateness of financial ties and their management, very little is known about the actual decision-making processes of university coi committees.” minimal187 to no regulatory guidance exists on basic matters such as how coics are to be constituted, the procedures they should follow, and the substantive criteria that should guide their reviews. this can leave coics woefully unprepared for simply assessing the financial relationships, let alone determining appropriate oversight steps. as a result, many important questions are left for ad hoc development by188 each coic. for example, what is the optimal membership composition between committee members with scientific backgrounds and lay perspectives? how to ensure coics have sufficient membership expertise to understand the underlying economic terms and other technical financial aspects of the business relationships they review? how significant must a conflict be for the coic to conclude the 184. 42 c.f.r. §§ 50.604(f), 50.605(a). 185. 42 c.f.r § 50.605(a)(1). 186. financial relationships and interests in research involving human subjects: guidance for human subject protection, 69 fed. reg. 26393, 26936 (may 12, 2004). 187. elizabeth a. boyd & lisa a. bero, defining financial conflict and managing research relationships: an analysis of university conflict of interest committee decisions, 13 sci. & engineering ethics 415, 416 (2007). 188. francesco pelliccia et al., transparency in medical research: time for a paradigm shift, 186 int’l j. cardiology 259, 260 (2015) (“[n]ot surprisingly, given all these complicated dynamics at play, [coics] reports enormous difficulties in making sense of the actual economic relationships and tracking how the money flows.”). https://doi.org/10.1007/s11948-007-9041-6 https://doi.org/10.1016/j.ijcard.2015.03.219 104 indiana health law review [vol. 15:67 financial relationship must be terminated? are coic reviews best done by reviewing form disclosures about each deal or by having the committee talk to the physicians involved? what type of follow-up should coics require once they institute a management plan? the unfortunate lack of guidance for coics stands in contrast to the more detailed regulations directed at institutional review boards (irbs) in their role in approving and monitoring proposed research studies for acceptable risk/benefit ratios and for ensuring protection of human subjects. 189 because of the minimal regulatory guidance for coics, inconsistency between coics in addressing similar financial relationships is a suspected problem. this parallels the well-known variability that has been identified with irbs. one of the only studies to examine the workings of coics in detail, a190 review of the deliberations of three coics at three public universities in california, found that the committees struggled in several respects, including consistency. the study observed that the coics had difficulty applying191 relevant policies about financial conflicts, did not work from a standardized definition of what was a conflict, and rarely ever recommended refusing research funding as a way of managing the conflict, although other less strict management plans were considered and recommended. on the one hand, the coics showed192 some flexibility in how they responded to identified financial conflicts, balancing concerns of academic freedom and professional autonomy with concerns of protecting subjects and providing accountability. on the other hand, this rather193 ad hoc process, with little express guidance for coics as to how to do their jobs, seems to have resulted in coics underutilizing their compliance roles. 194 it seems we may be expecting too much of coics to do their important work as conflicts monitors without further study as to whether coics are well designed to perform these tasks and without standardized guidelines for coics to follow. the risk is that the information uncovered by transparency programs195 like the sunshine act may end up being underutilized by coics and inconsistently acted upon. indeed, “disclosure without corresponding guidance [to coics] for the practical management of particular financial relationships may not be the ultimate solution to the problem of conflict of interest in academic research.” further, the failure to subject conflicts oversight to rigorous196 assessment means that coics operate without a strong empirical basis for 189. see 45 c.f.r. § 46 (hhs regulations, 2017); 21 c.f.r. § 56 (fda regulations, 2017). 190. carl schneider, the censor’s hand: the misregulation of human-subject research 82–83 (2015). 191. boyd & bero, supra note 187, at 430–431. 192. id. at 422–423, 431. 193. id. at 416. 194. id. at 433. 195. trust and integrity in biomedical research: the case of financial conflicts of interest 123 (thomas h. murray & josephine johnston, eds. 2010) (“there is, as yet, no comprehensive source of data on the oversight activities of universities….without data, it is difficult for institutions to learn from themselves or from one another in this area…”). 196. boyd & bero, supra note 187, at 433. 2018] financial conflicts in the new era of sunshine 105 determining which conflicts pose greater risk of bias and which management plans prove effective. in short, because there is such implicit reliance on coics to do important financial conflicts oversight in the face of new sunshine act disclosures, we need to know a lot more about how to ensure coics are up to the task. f. what about non-financial interests? the sunshine act exclusively focuses on financial relationships. this does not surprise. concern about financial conflicts has crowded out consideration of other secondary interests that can also bias health care decision-making. for example, the institute of medicine’s conflict of interest report focuses almost entirely on financial conflicts. likewise, many institutional policies and197 professional society guidelines address only financial conflicts. but what about198 non-financial influences that can also negatively impact a healthcare provider’s professional judgment and conduct? nonfinancial interests of this type include prestige, professional honors, career advancement, glory seeking, political predispositions, and intellectual zeal. 199 unfortunately, the evidence base is underdeveloped concerning the prevalence and influence of non-financial interests. there is no equivalent to the sunshine act in terms of comprehensive reporting of non-financial interests. public disclosure of non-financial interests has been very limited, such as with the international committee of medical journal editors (icmje)’s uniform disclosure rules that require medical journal authors to report certain nonfinancial interests in their publications. equally unclear is how to regulate non-200 financial interests, which are more intangible and amorphous compared to financial relationships. but enough is known to suspect that nonfinancial interests warrant greater regulatory attention. for example, in the clinical research context, investigations suggest that financial conflicts and certain non-financial interests, such as allegiance to a particular treatment approach, raise comparable concerns. both are associated with quite similar bias effects, including failure to publish negative results and selection of less effective interventions to compare against the favored approach. indirect and circumstantial evidence suggest that non-financial201 197. iom conflict of interest report, supra note 1, at xii (“[w]e focus on conflicts that involve financial interests because they are at the heart of concerns and debates about conflicts of interest.”). 198. see, e.g., protecting patients, preserving integrity, advancing health: accelerating the implementation of coi policies in human subjects research, aamc-aau (feb. 2008), https://members.aamc.org/eweb/upload/protecting%20patients,%20preserving%20integrity.pdf [https://perma.cc/ve55-latv] (concentrating exclusively on financial conflicts). 199. richard s. saver, is it really all about the money? reconsidering non-financial interests in medical research, 40 j.l. med. ethics 467, 468 (2012). 200. see int’l committee med. j. editors, supra note 21, at § 5. 201. see mario maj, non-financial conflicts of interest in psychiatric research and practice, https://doi.org/10.1111/j.1748-720x.2012.00679.x 106 indiana health law review [vol. 15:67 interests raise misaligned incentives problems on a regularly recurring basis. a review of scientific misconduct incidents reported on hhs’ office of research integrity’s website concluded that many of the reported incidents of faked data and other troubling actions to alter study results rarely appeared to involve researchers with conflicting financial interests, but instead involved non-financial pressures such as academic advancement pressures. researchers also202 anecdotally report that non-financial interests are widespread and, at times, pose more risk than financial interests.203 regulatory disregard of non-financial interests is concerning not only because of the risks they pose. financial conflicts regulations are simply inadequate when they address problematic provider and researcher behaviors likely influenced both by financial ties and non-financial interests. moreover, it may be unwise, and204 even impossible, to treat financial conflicts as a discrete, compartmentalized area of focus, as the sunshine act attempts to do. where financial ties end and nonfinancial interests begin is often unclear. non-financial rewards can also result in financial gain. an investigator’s enhanced academic reputation may be able to be monetized as it increases the researcher’s ability to attract grants or demand a higher salary. the boundary problems run in the other direction as well. financial ties can facilitate relationships that ultimately warrant concern primarily because of the social, not economic, influences introduced, such as the pressures of indebtedness, unconscious gratitude, and reciprocity that are thought to arise for physicians receiving even small gifts and low dollar payments. non-economic205 interests often not only accompany but also “modify and strengthen financial incentives.” the increasingly blurred distinctions between financial and non-206 financial interests calls into question the exclusive regulatory focus on financial conflicts. while the evidence base is limited regarding non-financial interests, they certainly combine with and magnify the risk of financial conflicts. thus, to improve regulation of financial conflicts generally, a great deal more needs to be learned about non-financial influences, including further research on their prevalence and impact, how they interact with financial conflicts, and the efficacy 193 brit. j. psychiatry 91, 91 (aug. 2008); making sense of non-financial competing interests, 5 plos med 1299, 1299 (sept. 30, 2008), http://journals.plos.org/plosmedicine/article?id= 10.1371/journal.pmed.0050199 [https://perma.cc/3xfq-uhml]. 202. jerry menikoff & ed richards, what the doctor didn’t say: the hidden truth about medical research 226 (2006). 203. see, e.g., david korn, conflicts of interest in biomedical research, 284 jama 2234, 2334 (2000). 204. yuval feldman et al., curbing misconduct in the pharmaceutical industry: insights from behavioral ethics and the behavioral approach to law, 41 j.l. med. ethics 620, 621 (2013). 205. lo, supra note 45, at 1720. 206. s.a. magnus, physicians' financial incentives in five dimensions: a conceptual framework for hmo managers, 24 health care mgmt. rev. 57, 67 (1999). https://doi.org/10.1192/bjp.bp.108.049361 https://doi.org/10.1371/journal.pmed.0050199 https://doi.org/10.1001/jama.284.17.2234 https://doi.org/10.1111/jlme.12071 https://doi.org/10.1097/00004010-199901000-00006 2018] financial conflicts in the new era of sunshine 107 of regulatory responses. vi. conclusion the new era of sunshine about financial conflicts has not been entirely radiant. considerable implementation challenges concerning data selection and communication have hampered the sunshine act’s rollout. these problems are likely inherent and unavoidable in transparency programs dealing with industrymedicine financial relationships. financial conflicts are particularly unwieldy subject matter for many reasons, including the complex transactions involved, the necessary importance of contextual and comparative information, the seeming low concern and disregard about financial conflicts among patients, and the inevitable, enduring uncertainty as to the actual causal impact of financial conflicts on the health care system. additionally, considerable doubts exist about the sunshine act’s effect on primary audiences, such as patients and physicians. the sunshine act suffers from uncertainty and poor design as to intended audience and mandatory disclosure has possible counterproductive behavioral effects. nonetheless, because of the sunshine act, a great deal more has been learned about industry-medicine financial dealings. the new era of sunshine has generated valuable information about the nature and scope of financial ties between industry and medicine, such as variations by clinical specialty, type of payment, and physician gender, all of which have important implications for health law and policy and can inform future evidence-based regulation. unfortunately, even with this greater understanding, knowledge gaps about financial conflicts remain and are not answerable by the sunshine act. these significant unknowns have become even more salient and vexing as they complicate and undermine effective financial conflicts regulation. a critical need for more evidentiary support exists in several key areas, including the actual causal impact of financial conflicts, the comparative effectiveness of different regulatory approaches, the optimal way to disclose conflicts, what patients really think about financial relationships with industry, and the role of institutional conflict of interest committees in monitoring financial ties. despite the new era of sunshine, much more work remains for developing sensible and effective financial conflicts regulation. indiana health law review volume xviii 2021 number 2 notes minding baby: the link between maternal depression and infant health and development paige ferise* we have a secret in our culture, and it’s not that birth is painful. it’s that women are strong. – laura stavoe harm i. introduction in 2018, during the state of the state address, indiana governor, eric holcomb, declared that indiana would have the lowest infant mortality rate in the midwest by 2024.1 this was a lofty goal in light of indiana’s historically poor ranking in infant mortality.2 in the two years since governor holcomb made this promise, several steps have been taken to work towards caring for mothers’ and babies’ physical health, but very little has been done to address maternal mental health or maternal trauma.3 there is a genetic and cyclical nature to trauma that causes mothers and babies to be disproportionately affected. mothers who experience trauma in childhood are more likely to experience depression during or after pregnancy. similarly, infants born to mothers who experienced untreated depression are at a higher risk for childhood trauma. much of the policy surrounding maternal care focuses on important aspects of prenatal care such as physical health, but largely ignores mental health. maternal depression can have devastating effects on babies ranging from attachment disorders to developmental delays. left untreated, maternal depression can cause adverse health outcomes; not only for the mother but also for the baby. maternal mental health and trauma screenings during pregnancy and * j.d. & m.p.h candidate, 2022, indiana university robert h. mckinney school of law & fairbanks school of public health; b.a. 2017, butler university. 1. governor eric holcomb, 2018 state of the state address: the next steps to the next level (jan. 9, 2018), https://www.in.gov/gov/2972.htm [https://perma.cc/jsn3-ygnu]. 2. infant mortality, ind. u. sch. med., https://medicine.iu.edu/expertise/indiana-health/ infant-mortality [https://perma.cc/37du-f26l] (last visited mar. 28, 2021) [hereinafter ind. u. sch. med.]. 3. my health baby: indiana’s ob navigator program, ind. st. dep’t health, https://www.in.gov/isdh/28233.htm [https://perma.cc/g2av-brmm] (last visited mar. 28, 2021). 372 indiana health law review [vol. 18:371 postpartum should be the required standard of care for all medicaid mothers, or for all mothers who are not enrolled in medicaid, but whose child is medicaid eligible. screening for, and offering services to treat, maternal mental health disorders can reduce adverse outcomes for infants – including infant death – and end the epigenetic cycle of mental illness and toxic stress that is particularly rampant in low-income communities. a. road map this note will begin with an overview of the background of maternal mental health in the united states. section ii will first describe in detail what maternal depression is and how it affects both mothers and infants. this section will give a brief history of maternal mental health in the united states and where the country, as well as the state of indiana, currently stands in terms of maternal depression screenings. section ii will then draw a connection between maternal mental health and infant mortality. this section will delve into specifics on infant mortality in the united states as well as in the state of indiana. finally, section ii will discuss the concept of adverse childhood experiences (“aces”) and the role that these experiences play on maternal mental health and infant health. this section will define aces as well as toxic stress and draw connections between trauma and public health. in section iii, this note will present a full literature review. first, section iii will give a literature review of the connection between maternal depression and adverse outcomes in infant health. this portion will dive further into research about the severe effect that maternal mental health can have on infant mortality. next, section iii will provide a full review of the research regarding the generational effect of maternal mental health and trauma. this section will define the term epigenetics and will provide research on the generational effects of toxic stress and mental health disorders on pregnant women and mothers. finally, section iii will provide an overview of research connecting maternal aces and toxic stress with infant health outcomes. specifically, this section will present research that draws a connection between maternal trauma and infant mortality rates. section iv will give a policy review of different jurisdictions in the united states. this section will go over various policies that touch on maternal mental health screenings, maternal aces screenings, as well as billing and reimbursement policies. section iv will compare and contrast policies in states that are geographically near indiana or states that are also in the bottom ten nationally for infant mortality. this portion will also discuss where indiana currently stands on maternal mental health policies. finally, section v will give policy recommendations for the state of indiana. this portion will draw from other state policies and make a proposal for how indiana can change and improve policy so as to better care for the mental health of mothers, and in turn, reduce infant mortality. 2021] minding baby 373 ii. background a. maternal depression maternal depression describes a wide variety of perinatal4 mental health conditions that can affect women throughout their pregnancy and postpartum.5 prenatal depression is a mental health condition that occurs during pregnancy.6 it is estimated that ten to twenty percent of mothers experience prenatal depression.7 symptoms can include crying or weepiness, lack of appetite, loss of enjoyment of regular activities, or poor fetal attachment.8 often prenatal depression can also include severe anxiety about the health of the baby or of the mother herself.9 depression during pregnancy is the greatest indicator for postpartum depression and women who present with depressive symptoms during pregnancy should be tested again after the birth.10 studies have shown that “[n]early [seventy-three] percent of women who report antepartum depression also experience postpartum depression, compared to [thirty-eight] percent of women who did not experience antepartum depression but later experienced it postpartum.”11 prenatal depression is easy to misdiagnose and is often reduced to a mother simply being hormonal. antenatal depression can have significant health effects on both mom and baby.12 experienced by as much as eighty percent of new mothers, the most common form of maternal depression is referred to as “baby blues.”13 baby blues tend to 4. perinatal refers to the period of time directly before (approximately twenty-two completed weeks of gestation) and after the birth of a child (seven completed days postpartum). maternal and perinatal health, world health org., https://www.who.int/maternal_child_ adolescent/topics/maternal/maternal_perinatal/en/ [https://perma.cc/ltd4-bnme] (last visited mar. 28, 2021). 5. what is maternal depression?, n.y. st. dep’t health, https://www.health.ny.gov/ community/pregnancy/health_care/perinatal/maternal_depression/providers/what_is_maternial_ depression.htm [https://perma.cc/9t6r-2h4j] (last updated jan. 2015). 6. id. 7. see anne-claude bernard-bonnin, can. pediatric soc’y, maternal depression and child development, 9 paediatrics & child health 575, 575 (2004). 8. what is maternal depression?, supra note 5. 9. juli fraga, prenatal depression may be the most severe form of maternal depression, wash. post (aug. 29, 2016), https://www.washingtonpost.com/news/to-your-health/wp/2016/ 08 /29/prenatal-depression-may-be-the-most-severe-form-of-maternal-depression / [https://perma.cc/57yf-zedn]. 10. margaret wile, from pregnancy to postpartum: the effects of maternal depression on mothers, infants and toddlers 1 (2019), https://www.ncsl.org/ research/ human-services/from-pregnancy-to-postpartum-the-effects-of-maternal-depression-on-mothersinfants-and-toddlers.aspx [https://perma.cc/c4ej-bd9p]. 11. id. (footnote omitted). 12. fraga, supra note 9. 13. what is maternal depression?, supra note 5. 374 indiana health law review [vol. 18:371 begin “during the first few weeks after delivery” and typically last between one and two weeks.14 symptoms can include weepiness, anxiety, irritability, mood swings, insomnia, and an exaggerated sense of empathy.15 baby blues are categorized as the “least severe form of postpartum depression.”16 the american pregnancy association recommends self-care such as maintaining a healthy diet and keeping a journal of feelings and moods as a way to combat baby blues.17 it is also recommended that new mothers experiencing these symptoms find someone they trust to talk with and ask for help when they need it.18 postpartum depression is the form of maternal depression that is most commonly discussed in literature and policy. postpartum depression is categorized by a sense of more persistent sadness and is distinguishable from baby blues by the length of time the emotional distress lasts.19 symptoms of postpartum depression include many of the symptoms of baby blues but also can include more severe symptoms such as difficulty bonding with baby, recurrent thoughts of self-harm or harming the baby, panic attacks, feelings of worthlessness or hopelessness, and fear of being a bad mother.20 in recent years, postpartum depression has been recognized as a major public health issue globally.21 studies conducted in the united states, the united kingdom, and australia show that, on average, ten to fifteen percent of new mothers experience postpartum depression.22 treatment for postpartum depression can include pharmacological therapy, cognitive behavioral therapy, or both.23 the most severe form of maternal mental illness is called postpartum psychosis (“pp”).24 pp symptoms generally begin as early as two to three days after birth and can last between one and four weeks.25 pp is rare and occurs only in one to two mothers out of 1000.26 pp is characterized by hallucinations, paranoia, inability to perform simple tasks, obsessive thoughts about harming the 14. id. 15. id. 16. baby blues, am. pregnancy ass’n (jan. 25, 2019), https://americanpregnancy.org/firstyear-of-life/baby-blues/ [https://perma.cc/7cxs-2eza] 17. id. 18. id. 19. what is maternal depression?, supra note 5. 20. mayo clinic staff, postpartum depression, mayo clinic (sept. 1, 2018), https://www. mayoclinic.org/diseases-conditions/postpartum-depression/symptoms-causes/syc-20376617 [https://perma.cc/5eff-26td]. 21. see generally elizabeth fitelson et al., treatment of postpartum depression: clinical, psychological and pharmacological options, 3 int’l j. women’s health 1 (2010). 22. id. at 1. 23. id. at 3. 24. what is maternal depression?, supra note 5. 25. dorothy sit et al., a review of postpartum psychosis, 15 j. women’s health 352, 353 (2006). 26. id. 2021] minding baby 375 child, excessive energy or agitation, and confusion.27 overwhelming research has shown that pp is linked to bipolar disorder, schizoaffective disorder, or schizophrenia.28 women who have a personal or family history of one or more of the above disorders are at the highest risk for developing pp.29 this disorder requires immediate medical attention and treatment that often includes both medical intervention as well as cognitive and behavioral therapy.30 though any mother can experience depressive symptoms after the birth of any child, there are some risk factors that can make certain people predisposed to perinatal mental illness.31 those with a history of mental illness, both during pregnancy and prior to pregnancy, are more likely to experience some form of maternal mental illness.32 mothers who have a childhood trauma history (e.g., aces), particularly of sexual assault, are also more at risk for maternal depression.33 higher-risk pregnancies and traumatic deliveries are also related to a higher risk of developing depressive symptoms.34 age can be a risk factor and the highest rates of depression have been observed in young mothers aged thirteen to nineteen years old.35 perhaps the biggest risk factor for developing maternal depression is social isolation. the existence of a poor relationship with the father of the child, or a lack of support from other family members has been shown to have a significant effect on the development of depressive symptoms.36 “in addition to the [woman's] relationship with family members and [the] community, behaviors such as smoking during [the] prenatal period, [are] . . . social factors associated with increased incidence of postpartum depression a[t] 1.7 times.”37 finally, socioeconomic status, as well as education, play a role in the development of depressive symptoms.38 though each of the above-mentioned maternal mental illnesses is incredibly important in its own right, this note will focus largely on baby blues and postpartum depression due to the higher rate of occurrence of both conditions as well as the effect that they have on maternal and infant health. 27. id.; mayo clinic staff, supra note 20. 28. see sit et al., supra note 25; kimberly a. yonkers et al., management of bipolar disorder during pregnancy and the post-partum period, 161 am. j. psychiatry 608 (2004); ian brockington & antoine guedeney, motherhood and mental health, 2 infant observation 116 (1999). 29. yonkers et al., supra note 28. 30. mayo clinic staff, supra note 20. 31. what is maternal depression?, supra note 5. 32. id. 33. see maryam ghaedrahmati et al., postpartum depression risk factors: a narrative review, 6 j. ed. & health promotion art. 60 (2017). 34. see id. 35. id. at 16. 36. see id. at 23-24. 37. id. at 24 (footnote omitted). 38. id. 24-25. 376 indiana health law review [vol. 18:371 b. infant mortality infant mortality is defined as “the death of an infant before his or her first birthday.”39 the infant mortality rate is calculated as the number of infant deaths for every 1,000 live births, and there were 4.1 million infant deaths globally with an average mortality rate of twenty-nine deaths for every 1,000 live births.40 the highest average rate was in the africa region, as categorized by the world health organization (“who”).41 though infant death may seem to be a problem of the past for the global north, it continues to plague even the wealthiest nations. the infant mortality rate in the who europe region is eight deaths per 1,000 live births.42 the overall infant mortality rate in the united states is 5.8 deaths for every 1,000 live births.43 as with many other public health issues in the united states, infant death is not experienced equally throughout the country. new hampshire has the lowest rate of infant death with only 3.9 deaths per 1,000 births.44 mississippi has the highest rate of infant death with 9.1 deaths per 1,000 births.45 the disparity in infant deaths goes beyond geographic location. race plays a significant role in infant mortality with the average rate for african american infants being 10.9 per 1,000 births, nearly twice that of the national average.46 similarly, native american populations also experience considerably higher rates of infant death with the average in these populations being 8.4 per 1,000 births.47 this note will focus on infant death rates in indiana. of the fifty united states, indiana ranks forty-third for infant mortality, reporting 7.4 deaths per 1,000 live births in 2019.48 indiana’s infant death rate is more than twenty percent higher than the national average.49 in 2017, 601 infants died before their first birthday, and of those deaths, twenty-five percent occurred in just three percent 39. infant mortality, ctr. for disease control & prevention, https://www.cdc.gov/ reproductivehealth/maternalinfanthealth/infantmortality.htm [https://perma.cc/tjf2-589b] (last updated sept. 10, 2020) [hereinafter cdc]. 40. infant mortality, world health org., https://www.who.int/gho/child_health/mortality/ neonatal_infant_text/en/ [https://perma.cc/2vc9-g5bv] (last visited mar. 28, 2021). 41. id. the who categorizes its member states into six regions: african region, region of the americas, south-east asian region, european region, eastern mediterranean region, and western pacific region. 42. id. 43. cdc, supra note 39. 44. infant mortality, am. health rankings (2019), https://www.americashealthrankings. o r g / e x p lo r e / h e a l t h -o f -w o m e n -a n d -c h ildren /m easu re / imr _ mc h /s t a t e / al l [https://perma.cc/h5xk-fyu2] [hereinafter am. health rankings]. 45. id. 46. id. 47. id. 48. id. 49. ind. u. sch. med., supra note 2. 2021] minding baby 377 of the state’s zip codes.50 indiana also experiences extreme racial disparities in infant mortality. in 2017, the rate of infant death for african american babies in indiana was 12.5 per 1,000.51 in that same year, the rate for hispanic babies was 7.8 per 1,000 births.52 comparatively, the rate of infant death for white infants in indiana was only 6.1 per 1,000 births in 2017.53 there are several reasons why an infant may die before their first birthday. in 2017, the centers for disease control and prevention (“cdc”) ranked birth defects as the leading reason for infant death.54 the cdc did not provide an explanation as to what the most common birth defects were, or if the defects were genetic or due to prenatal risks taken by the mother. rounding out the top five, the causes of death that were identified by the cdc were preterm birth or low birth weight, maternal and pregnancy complications, sudden infant death syndrome (“sids”), and injuries such as suffocation.55 indiana categorizes its infant deaths into most the common causes. the largest number of infant deaths in indiana (forty-eight percent) is attributed to perinatal risks.56 perinatal risks can include mental health conditions as well as physical health conditions such as obesity, hypertension, diabetes, or heart disease.57 other perinatal risks can include tobacco use, alcohol use, or illicit drug use.58 the next highest percentage of infant deaths in indiana can be attributed to congenital malformations.59 the remainder of infant deaths in indiana is due to 50. id. 51. am. health rankings, supra note 44. 52. id. 53. infant mortality, ind. dep’t health, https://www.in.gov/isdh/27470.htm [https://perma. cc/5prw-y4gk] (last visited july 20, 2020). 54. cdc, supra note 39. 55. id. a preterm birth is one that occurs prior to the thirty-seventh week of gestation, or three weeks early. the earlier a baby is born, the more likely it is to experience complications. mayo clinic staff, premature birth, mayo clinic (dec. 21, 2017), https://www.mayoclinic.org/ diseases-conditions/premature-birth/symptoms-causes/syc-20376730 [https://perma.cc/xv6sb4uk]. low birth weight is defined as a baby born weighing less than five pounds and eight ounces. low birth weight, u. rochester med. ctr., https://www.urmc.rochester.edu/ encyclopedia/content.aspx?contenttypeid=90&contentid=p02382 [https://perma.cc/2quw-9cuy]. 56. ind. u. sch. med., supra note 2. 57. pregnancy complications, ctr. for disease control & prevention (oct. 23, 2018), h t t p s : / / w w w . c d c . g o v / r e p r o d u c t iv e h e a l t h / m a te rn a lin fan th ea lth /pregn an cycomplications.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2freproductivehealth %2fmaternalinfanthealth%2fpregcomplications.htm [https://perma.cc/7ntx-ee3f]; maternal, infant, and child health, off. disease prevention & health promotion, https://www. healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health#top [https://perma.cc/lpb7-ka7m] (last visited mar. 28, 2021). 58. mayo clinic staff, sudden infant death syndrome (sids), mayo clinic (may 20, 2020), https://www.mayoclinic.org/diseases-conditions/sudden-infant-death-syndrome/symptomscauses/syc-20352800 [https://perma.cc/n3k6-elan]. 59. am. health rankings, supra note 44. 378 indiana health law review [vol. 18:371 sids (14.4 percent), accidents or assaults (4.5 percent), and what is referred to as “other” (12.7 percent).60 though many of the leading causes of infant death, such as sids, may not necessarily be preventable, there are ways to reduce the risks. one of the best ways to reduce the risk of adverse infant health is to receive appropriate prenatal care.61 once the infant is born, infant health care and education for the mother on how to best care for the baby – particularly on subjects such as safe sleep practices and feeding – can help to reduce an infant’s risk of death in their first year of life.62 c. adverse childhood experiences and toxic stress the term adverse childhood experiences (“aces”) encompasses a multitude of traumas and toxic stress experienced prior to a person’s eighteenth birthday.63 these traumas can include physical abuse, witnessing the abuse of a parent, food or shelter insecurity, substance abuse by a parent, or parental incarceration.64 approximately sixty percent of adults in america have experienced one or more adverse experiences in childhood.65 on average, 20.5 percent of american children aged zero to seventeen experienced two or more adverse events in 2019.66 the seminal study on aces was conducted in 1997 by kaiser permanente health and the cdc.67 the study showed “a strong graded relationship between the breadth of exposure to abuse or household dysfunction during childhood and multiple risk factors for several of the leading causes of death in adults.”68 60. ind. univ. sch. med., supra note 2. there is no definitive reason for sids, but there are some risk factors including preterm birth and low birth weight. sids fact sheet, ill. dep’t health, http://www.idph.state.il.us/sids/sids_factsheet.htm [https://perma.cc/4zbj-m83s] (last visited mar. 28, 2021). 61. are there ways to reduce the risk of infant mortality?, nat’l inst. child health & hum. dev., https://www.nichd.nih.gov/health/topics/infant-mortality/topicinfo/reduce-risk [https:// perma.cc/s7gw-je75] (last visited mar. 28, 2021). 62. id. 63. tracy flanagan et al., feasibility and acceptability of screening for adverse childhood experiences in prenatal care, 27 j. women’s health 903, 903 (2018). 64. laura starecheski, take the ace quiz – and learn what it does and doesn't mean, npr (mar. 2, 2015), https://www.npr.org/sections/health-shots/2015/03/02/387007941/take-theace-quiz-and-learn-what-it-does-and-doesnt-mean [https://perma.cc/8pba-qvg9]. 65. flanagan et al., supra note 63. 66. adverse childhood experiences, am. health rankings (2019), https://www. americashealthrankings.org/explore/health-of-women-and-children/measure/aces/state/in [https://perma.cc/zz25-2d2q]. 67. about the cdc-kaiser ace study, ctr. for disease control & prevention, https://www.cdc.gov/violenceprevention/childabuseandneglect/acestudy/about.html [https://perma.cc/b32d-767x] (last updated apr. 13, 2020). 68. vincent j. felitti et al., relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: the adverse childhood experiences (ace) study, 14 am. j. prev. med. 245, 245 (1998). 2021] minding baby 379 though the study was conducted in the late 1990s, the results did not gain significant attention until well into the 2000s when the current surgeon general of california, dr. nadine burke harris, took notice in her practice of the effects of trauma on her pediatric patients.69 dr. harris began research of her own and is now one of the leading experts on aces and ace policy.70 since then, aces have become a centerpiece of early childhood research.71 however, research on adult outcomes, and more specifically the effects of trauma on expecting mothers, is still limited. one connection that has been fairly well-established in the literature is the connection between maternal depression and trauma experienced by the mother in childhood.72 a number of studies have found a connection between the number of aces experienced by a mother and her risk of developing some form of perinatal depression.73 a dose-response relationship was reported between the number of aces and the likelihood of developing either prenatal or postpartum depression; the higher a mother’s ace score, the more likely she was to develop depression at some point.74 stress is a common part of life for all humans, but particular types of stress can be damaging to developing children. there are three generally recognized types of stress: positive stress, tolerable stress, and toxic stress.75 positive stress refers to the normal, healthy stress that all people experience during childhood and adolescence.76 examples of positive stress for a child could include the first time at school or daycare away from a parent, or routine doctor’s visits and 69. see generally nadine burke harris, the deepest well: healing the long-term effects of childhood adversity 1 (2018). 70. id. 71. see sukhdip k. purewal et al., screening for adverse childhood experiences (aces) in an integrated pediatric care model, 36 zero to three j. 10, 10-17 (2016); yael cannon, a mental health checkup for children at the doctor’s office: lessons from the medical-legal partnership movement to fulfill medicaid’s promise, 17 yale j. health pol’y. l. ethics 253 (2017); jack p. shonkoff et al., the lifelong effects of early childhood adversity and toxic stress, 129 pediatrics e232 (2012). 72. see esther k. chung et al., depressive symptoms in disadvantaged women receiving prenatal care: the influence of adverse and positive childhood experiences, 8 ambulatory pediatrics 109 (2008); joshua p. mersky & colleen e. janczewski, adverse childhood experiences and postpartum depression in home visiting programs: prevalence, association, and mediating mechanisms, 22 maternal & child health j. 1051 (2018). 73. see generally chung et al., supra note 72; mersky & janczewski, supra note 72. 74. chung et al., supra note 72. a dose-response, which involves a relationship between an exposure and the risk of an outcome, is a relationship where increasing levels of an exposure are associated with either an increasing or a decreasing risk of an outcome. sydney pettygrove, doseresponse relationship, britannica, https://www.britannica.com/science/dose-responserelationship [https://perma.cc/w6l2-94uj] (last visited mar. 29, 2021). 75. toxic stress, ctr. on developing child harv. u., https://developingchild. harvard. edu/science/key-concepts/toxic-stress/ [https://perma.cc/yxg7-g5th] (last visited mar. 20, 2020). 76. id. 380 indiana health law review [vol. 18:371 immunizations.77 the “middle level” of stress is referred to as tolerable stress. tolerable stress “activates the body’s alert systems to a greater degree as a result of more severe, longer-lasting difficulties.”78 examples of tolerable stress would be the loss of a loved one or a serious injury or illness.79 while both of these forms of stress can have serious implications, supportive adult relationships that enhance a child’s ability to cope will generally allow a child to recover from them.80 the strongest and most damaging form of stress is called toxic stress. stress becomes toxic after prolonged exposure to extreme trauma experiences.81 living under this level of stress for long periods of time creates a buildup of cortisol – the hormone that is released during times of stress or anxiety.82 large amounts of cortisol in the body can result in a number of adverse effects including developmental delay and cognitive development.83 examples of toxic stress include prolonged physical, sexual, or emotional abuse, prolonged periods of poverty or food instability, exposure to substance abuse, or the death or imprisonment of a caregiver.84 once stress becomes toxic, the cumulative effect on a child can result in negative health impacts for the remainder of their life.85 a method for screening for aces has been developed and proved to be effective.86 the screening consists of ten yes-or-no survey questions regarding three areas of childhood trauma: abuse, neglect, and household dysfunction.87 the aces assessment has been shown to take less than ten minutes.88 the screening has been tested in clinical settings and shown to be an accurate predictor of health outcomes.89 iii. literature review a. connection between maternal depression and infant health outcomes maternal depression, both during pregnancy and after, has shown to have 77. id. 78. id. 79. id. 80. what is toxic stress, fla. st. u., https://med.fsu.edu/childstress/whatis [https://perma. cc/q3nh-bpxa] (last visited mar. 20, 2020). 81. id. 82. harris, supra note 69, at 21. 83. see toxic stress, supra note 75. 84. id. 85. id. 86. felitti et al., supra note 68, at 246-49. 87. meryl schulman & alexandra maul, screening for adverse childhood experiences and trauma, ctr. for health care strategies (feb. 2019), https://www.chcs.org/media/ta-toolscreening-for-aces-and-trauma_020619.pdf [ https://perma.cc/869f-94me]. 88. id. 89. see id. 2021] minding baby 381 significant health effects on the infant both in utero and after birth.90 depression creates a chemical change in the mother that directly affects hormone production and can have dangerous ramifications for the infant.91 these changes in hormones can cause preterm birth, low birth weight, and cognitive and developmental delay in babies.92 preterm birth and low birth weight are also two of the biggest contributors to infant death.93 a study conducted in sweden between 2007 and 2012 examined more than 350,000 births.94 researchers tested both parents for depression, followed the pregnancy, and then recorded if the infant was born either very preterm (born between twenty-two and thirty-one weeks) or moderately preterm (born between thirty-one and thirty-six weeks).95 the study showed that mothers who had new or recurrent depression had between a thirty percent and forty percent increased risk for moderately preterm birth.96 one of the most important aspects of infant development is called “serve and return.”97 serve and return refers to the “give and take” exchange between infants and adults where infants react to adult interaction and vice versa.98 an example of a serve and return interaction would be an adult making a silly face at a baby, which in turn results in the baby responding by giggling.99 maternal depression has been shown to affect a mother’s ability to perform the serve and return pattern that is essential to an infant’s brain development.100 babies who do not receive this stimulation at a young age can experience developmental and cognitive delays.101 babies who are consistently deprived of the necessary serve and return exchange can suffer from toxic stress that can ultimately lead to adverse health outcomes and continue the cycle for future generations.102 b. generational effects of maternal depression and toxic stress maternal mental health and maternal trauma are public health issues. trauma and mental health disorders experienced by mothers can directly affect the health 90. wile, supra note 10. 91. id. 92. id. 93. ind. u. sch. med., supra note 2. 94. depression of either parent during pregnancy linked to premature birth, sciencedaily (jan. 20, 2016), www.sciencedaily.com/releases/2016/01/160120091754.htm [https://perma.cc/l9wa-hqf3]. 95. id. 96. id. 97. wile, supra note 10. 98. id. 99. id. 100. maternal depression in rhode island: two generations at risk, r.i. kids count (jan. 2018), http://rikidscount.org/portals/0/uploads/documents/issue%20briefs/3.18%20maternal% 20depression%20update.pdf [https://perma.cc/mr7p-weey]. 101. id. 102. wile, supra note 10. 382 indiana health law review [vol. 18:371 of their infant and may even have a generational effect. epigenetics is the idea that trauma can leave a “chemical mark” on a person’s genes and be passed down to future generations.103 this leads to a seemingly endless cycle of trauma and associated mental health disorders. several studies have shown direct correlations between high rates of childhood trauma in mothers and poor health outcomes in infants.104 in addition, studies have shown that mothers with multiple aces are more likely to develop depression.105 trauma changes the chemistry in the brain in a way that is inheritable.106 even if the child themselves never experience trauma, they may still experience poor health outcomes that are associated with trauma, simply because their mother had a high prevalence of aces.107 this can also be true for maternal depression. recent studies have shown that there is now “converging evidence supporting the idea that offspring are affected by parental trauma exposures occurring before their birth, and possibly even prior to their conception.”108 trauma experienced by the mother can be passed genetically to her infant and the effects of such trauma can be felt for multiple generations. studies done regarding epigenetics and health risk behaviors during pregnancy have shown that the behaviors of a mother will not only affect the child but can affect up to three additional generations.109 studies have shown that early traumatic experiences evoke a cascade of system-wide changes that persist into adulthood and then those genetic changes can be passed along to future generations.110 c. adverse childhood experiences and maternal and fetal health exposure to trauma in childhood has been shown to affect mothers and babies both during pregnancy and birth, as well as after the birth of the child.111 though 103. benedict carey, can we really inherit trauma?, n.y. times (dec. 10, 2018), https://www.nytimes.com/2018/12/10/health/mind-epigenetics-genes.html [https://perma.cc/5vwpkxxz]. 104. see christina g. mcdonnell & kristin valentino, intergenerational effects of childhood trauma: evaluating pathways among maternal aces, perinatal depressive symptoms, and infant outcomes, 21 child maltreatment 317, 317-26 (2016); see also nicole racine et al., maternal adverse childhood experiences and infant development, 141 pediatrics art. e20172495 (2018). 105. see karen a. ertel et al., maternal depression in the united states: nationally representative rates and risks, 20 j. women’s health 1609 (2011). 106. rachel yehuda & amy lehrner, intergenerational transmission of trauma effects: putative role of epigenetic mechanisms, 17 world psychiatry 243, 243-57 (2018). 107. id. 108. id. 109. carey, supra note 103. 110. nicole r. nugent et al., topical review: the emerging field of epigenetics: informing models of pediatric trauma and physical health, 41 j. pediatric psychol. 55, 55-64 (2016). 111. see megan v. smith et al., early childhood adversity and pregnancy outcomes, 20 maternal child health j. 790 (2016). 2021] minding baby 383 this is a relatively new field of research, several studies have found that “a doseresponse relationship exists between the number of reported adverse childhood events and risk of having an operative delivery or infant’s admission to the neonatal intensive care unit.”112 adverse childhood experiences can also lead to difficulties in pregnancy including maternal depression and substance abuse.113 screening for trauma can inform care during pregnancy and potentially reduce the adverse health outcomes that have been shown the be associated with higher rates of trauma in childhood. in indiana, this is particularly of importance because indiana’s maternal and infant mortality rate is higher than the national rate of such.114 children of mothers who have been exposed to aces are at increased risk of a multitude of poor health and developmental outcomes.115 these outcomes can include delayed achievement of developmental milestones and increased likelihood of parent-child relationship difficulties in infancy.116 numerous studies have shown that there is a significant connection between a high number of aces experienced by the mother and her development of maternal depression.117 a study conducted with low-income pregnant women of all ages and races showed that the prevalence of aces, particularly in lowincome women, was significantly higher than the original aces study estimated.118 furthermore, the study found that there was a very high association between aces and postpartum and antepartum depression.119 results showed that exposure to aces increases the risk of adverse adult experiences, which also increases the risk of poor mental health.120 iv. policy review a. recommendations from u.s. health care organizations several u.s. health care organizations have published recommendations on screening mothers for perinatal depression.121 the american college of 112. id. at 791. 113. racine et al., supra note 104. 114. indiana summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/in?editionyear=2019 [https://perma.cc/v8px-94bk]. 115. racine et al., supra note 104. 116. id. 117. see mersky & janczewski, supra note 72, at 1058; jasmine e. kim et al., the association between maternal adverse childhood experience and maternal depression: a longitudinal cohort study, 57 j. am. acad. child adolescent psychiatry s227 (2018); racine et al., supra note 104. 118. mersky & janczewski, supra note 72. 119. id. 120. id. 121. see comm. on obstetric practice, am. coll. of obstetrics & gynecologists, screening for perinatal depression, 132 obstetrics & gynecology e208 (2018); screening process 384 indiana health law review [vol. 18:371 obstetricians and gynecologists published a committee opinion in 2018 (the original opinion was published in 2015 but updated in 2018) recommending that all providers “complete a full assessment of mood and emotional well-being (including screening for postpartum depression and anxiety with a validated instrument) during the comprehensive postpartum visit for each patient.”122 similarly, the american academy of pediatrics (“aap”) recommends screening the mother for depression during an infant’s well-child visit.123 the aap argues that untreated maternal depression can “lead to impaired parent-child interaction, discontinuation of breastfeeding, child abuse and neglect, and family dysfunction.”124 other pediatric and maternal health organizations are in agreement on the importance of screening and treating maternal depression. the association of women’s health obstetric and neonatal nurses (“awhonn”) stated in a formal opinion that “all postpartum women should be screened for mood and anxiety disorders.”125 the awhonn also recommends “systematic screening in pregnancy and the postpartum period [to] help detect early symptoms of perinatal psychiatric distress.”126 b. current indiana policy in the 2019 session of the indiana general assembly, house bill 1007 was passed.127 the law established a perinatal navigator program called the ob navigator program.128 the program, which was slated to begin in january 2020, is in a pilot stage, with only twenty-two of indiana’s ninety-two counties participating at the outset.129 “the ob navigator program is a collaboration between the indiana state department of health (isdh), the indiana family and social services administration (fssa) and the indiana department of child services (dcs).”130 this initiative will create a network of wraparound services resources, am. acad. pediatrics, https://www.aap.org/en-us/advocacy-and-policy/aap-healthinitiatives/screening/pages/screening-recommendations.aspx [https://perma.cc/66y7-46hk] (last visited feb. 2, 2021); marian f. earls et al., incorporating recognition and management of perinatal depression into pediatric practice, 143 pediatrics art. 20183259 (2019); assoc. of women’s health, obstetric & neonatal nurses, mood and anxiety disorders in pregnant and postpartum women, 44 j. obstetric, gynecologic & neonatal nursing 687, 689 (2015); nat’l assoc. of pediatric nurse practitioners, napnap position statement on the pnp’s role in supporting infant and family well-being during the first year of life, 25 j. pediatric health care 9a (2011). 122. see comm. on obstetric practice, supra note 121. 123. see screening process resources, supra note 126. 124. id. 125. assoc. of women’s health, obstetric and neonatal nurses, supra note 121, at 687. 126. id. 127. ind. code § 16-35-11-3 (2019). 128. id. 129. my health baby: indiana’s ob navigator program, supra note 3. 130. id. 2021] minding baby 385 to support healthier outcomes for mothers and babies.131 the program will require health care providers who provide maternal care in indiana’s most at-risk counties to administer a “validated and evidence-based verbal screening tool to assess substance abuse” in pregnant patients.132 if, after using the screening tool, a health care provider identifies a pregnant woman who has a substance use disorder and is not currently receiving treatment, the health care provider must: (1) provide treatment to the patient; or (2) refer the patient to treatment.133 although the act only specifies that maternal health providers screen for and treat substance abuse, the intent is that the program will go far beyond just treating moms with substance use disorder. the ob navigator program will include a sliding scale of care for women who are pregnant and on medicaid.134 the levels of care will include, from least intervention to most intervention, the following initiatives: healthy families indiana, community health partners, the paramedic program, and the nurse-family partnership.135 dcs is already providing home visitation services via its healthy families indiana program.136 this program operates in every county in the state and offers home visitation services for children and families. it is a “voluntary evidencebased home visitation program that is designed to promote healthy families and healthy children through a variety of services including child development, access to health care, and parent education.”137 at this level, mothers who have had previous uncomplicated pregnancies will be provided education and support, but no other interventions.138 the second tier of care in the ob navigator program will be the community health partners.139 this tier is for women who are not immediately flagged as high risk, but who perhaps have not had a pregnancy previously, or who need more support than other mothers. the third level of care will be the paramedic program.140 this level is designated for women who are at a higher risk of fetal or maternal health issues. women who have had previous issues with pregnancies, or who are already engaging in health-risk behaviors may be assigned to this level. at this level, the women will have access to their assigned paramedic who will be available to assist them with any potential health issues that arise, as well as continually check in with the women for routine health screenings during their pregnancy.141 the final level, and the level with the greatest amount of intervention, will be 131. id. 132. h.b. 1007, 121st gen. assemb., 1st reg. sess. (ind. 2019). 133. id. 134. my health baby: indiana’s ob navigator program, supra note 3. 135. id. 136. id. 137. id. 138. id. 139. id. 140. id. 141. id. 386 indiana health law review [vol. 18:371 the nurse-family partnership.142 women who are actively engaging in health-risk behaviors and are consequently at the highest risk will be assigned to this level. women who are weening off of illicit substances, such as opioids, would be assigned to this level. nurses are assigned to the mothers and are available for the women for the duration of their pregnancy to assist with health issues and monitor the mother during treatment.143 indiana’s standards for prenatal care currently only address the requirements for hospitals, birthing centers, neonatal care, and physicians.144 the standards do not address maternal mental health, or the requirement of any screenings during any point in the pregnancy or postpartum.145 c. maternal mental health and trauma screening policy in other states in the united states, thirty-five states plus the district of columbia have implemented policies that require or recommend maternal mental health screenings both during and after the pregnancy.146 some of the states have continuing education requirements for providers, and some have created an outline for how the providers will be reimbursed for the screening services.147 this portion of the note will review policies in states that are geographically or politically similar to indiana, or states that are also ranked in the bottom ten nationally for infant mortality as well as discuss some of the infant and maternal health statistics for the states under review. 1. georgia georgia is ranked as one of the worst states for infant mortality. they currently are ranked as forty-five out of fifty with 7.6 deaths per 1,000 live births.148 as a response, georgia added screening for maternal depression as a requirement during well-child visits.149 georgia’s provider manual, detailing the state’s early and periodic screening, diagnostic and treatment services (“epsdt”), requires that all medicaid mothers be screened for depression during 142. id. 143. id. 144. see generally 410 ind. admin. code art. 39 (2020) (addressing indiana maternal care standards). 145. see generally id. 146. medicaid policies for maternal depression screening (mds) during well-child visits, by state, nat’l acad. for st. health pol’y (mar. 1, 2018), https://healthychild.nashp.org/wpcontent/uploads/2018/04/nashp-mds-table-4.24.18.pdf [https://perma.cc/w4ab-em85]. 147. id. 148. georgia summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/ga?editionyear=2019 [https://perma.cc/nu9p-7q45]. 149. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 2021] minding baby 387 their child’s one-, two-, four-, and six-month visits.150 the reimbursement rate for screenings is $3.95 per screening and is included as part of georgia’s epsdt.151 if a mother screens positive for depression she is referred to the georgia crisis and access line (“gcal”).152 “gcal, a statewide toll free crisis hotline, provides access to resources and services to individuals in need of crisis management for mental health, addictive disease, and crisis services.”153 this service is available to anyone who needs it twenty-four hours a day and seven days a week by phone or website.154 2. mississippi mississippi has the highest infant mortality rate of all fifty states at 9.1 deaths per 1,000 live births.155 the state implemented required screenings for maternal depression during the first six months of an infant’s life.156 screenings are administered once during the infant’s one-, two-, four-, and six-month visits.157 the screening is reimbursable by fee for service at the rate of $3.65 per screening.158 caregivers other than the child’s mother are not eligible for screenings.159 3. michigan michigan added maternal depression screenings as a required portion of epsdt in 2017 and implemented the practice in 2018.160 mothers are to be 150. div. of medicaid, ga. dep’t of cmty. health, part iii: policies and procedures for early and periodic screening, diagnostic and treatment (epsdt) services – health check program (cos 600) (2021), at ix-15, https://www.mmis.georgia.gov/portal/portals/ 0/staticcontent/public/all/handbooks/epsdt%20services%20health%20check%20program%20m anual%2020201216205300.pdf [https://perma.cc/7hks-uqjy]. 151. id. at x-9. 152. id. 153. id. 154. id. 155. mississippi summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/ms?editionyear=2019 [https://perma.cc/h5gt-vv25]. 156. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 157. epsdt periodic examination schedule, miss. division medicaid, https://medicaid.ms. gov/wp-conten t/uploads/2016/07 /epsdt-periodicity-examination-schedule.pdf [https://perma.cc/ac6m-22en] (last visited mar. 29, 2021). 158. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 159. id. 160. see mich. dep’t of health & human servs., bulletin no. msa 17-34, updates to the early and periodic screening, diagnosis and treatment chapter of the medicaid 388 indiana health law review [vol. 18:371 screened per the aap’s guidelines which recommend screening at the infant’s one-, two-, four-, and six-month well-visits.161 michigan has included maternal depression screenings as part of its infant mortality reduction plan.162 the infant mortality rate in michigan has been slowly declining from 2016, when it was at 7.0 deaths per 1,000 live births, to 2019, when it was 6.5 deaths per 1,000 live births.163 4. texas texas passed legislation that not only addresses the importance of maternal mental health screening but also lays out a plan for how providers will be reimbursed. the texas statute states that “[t]he covered services under the child health plan must include a maternal depression screening for an enrollee's mother, regardless of whether the mother is also an enrollee, that is performed during a covered well-child or other office visit for the enrollee that occurs before the enrollee's first birthday.”164 this progressive stance on maternal mental health screening allows for greater access to care, something that is particularly important in texas where 25.6 percent of women in the state are uninsured.165 since these changes have been made, infant deaths in texas are trending down. the texas infant mortality rate for 2019 was 5.7 deaths per 1,000 births.166 this is lower than the national average and lower than the previous three years in texas.167 these numbers show that screening for maternal depression during well-child visits successfully reduces infant deaths. 5. illinois illinois has an infant mortality rate of 6.2 deaths per 1,000 births, which is higher than the national average.168 illinois has a maternal mortality rate of 21.4 provider manual and 2017 american academy of pediatrics periodicity schedule 1 (2017), https:/ /www.michigan.gov/documents/mdhhs/msa_17-34_607322_7.pdf [https://perma.cc/vj3g-vdms]. 161. see id. at 2. 162. see medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146; mich. dep’t of health & human servs., mother infant health & equity improvement plan 1 (2020), https://www.michigan.gov/documents/ infantmortality/final_miheip_665052_7.pdf [https://perma.cc/nw49-w8cn]. 163. mich. dep’t of health & human servs., supra note 160. 164. tex. health & safety code § 62.1511 (2019). 165. texas summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/tx?editionyear=2019 [https://perma.cc/v88q-m7hm]. 166. id. 167. id. 168. illinois summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/il?edition2021] minding baby 389 deaths per 100,000 live births.169 the rate of postpartum depression is 9.3 percent.170 in the 2019 session of the illinois general assembly, a bill recognizing the importance of maternal mental health was passed.171 a further bill was passed to require educational materials to be distributed at all birthing hospitals statewide.172 the statute states in part that [t]he department shall develop educational materials for health care professionals and patients about maternal mental health conditions. a birthing hospital shall, on or before january 1, 2021, distribute these materials to employees regularly assigned to work with pregnant or postpartum women and incorporate these materials in any employee training that is related to patient care of pregnant or postpartum women.173 the statute goes on to describe what the materials should include, such as materials for physicians and hospital staff on how to recognize maternal depression, as well as materials for new mothers and fathers on signs and symptoms of maternal depression.174 this is not the first time that illinois sought to address maternal depression. in 2008, it was one of the first states to pass legislation regarding maternal mental health and screening practices.175 the perinatal mental health disorders prevention and treatment act compels health care professionals to meet certain requirements, including both prenatal care as well as postnatal care.176 for prenatal care, providers must present educational material on maternal mental health disorders to all patients.177 in addition, [l]icensed health care professionals providing prenatal care at a prenatal visit shall invite each pregnant patient to complete a questionnaire and shall review the completed questionnaire . . . . assessment for perinatal mental health disorders must be repeated when . . . a reasonable possibility exists that the woman suffers from perinatal mental health disorders.178 the statute also covers postnatal care, requiring that all birthing hospitals year=2019 [https://perma.cc/9x8s-fpfp]. 169. id. 170. id. 171. 405 ill. comp. stat. 120/5 (2020). 172. id. 173. id. 174. id. 175. screening and treatment for perinatal mental health disorders, ill. dep’t hum. serv., https://www.dhs.state.il.us/page.aspx?item=35251 [https://perma.cc/3lzc-ejvm] (last visited mar. 29, 2021). 176. 405 ill. comp. stat. ann. 95/15 (2019). 177. id. 178. id. 390 indiana health law review [vol. 18:371 distribute educational materials to the mothers (and if possible, fathers) prior to discharge and offer screening services to all mothers receiving postnatal care.179 finally, the statute covers screenings at well-baby visits.180 the statute provides that “[l]icensed health care professionals providing pediatric care to an infant shall invite the infant's mother to complete a questionnaire at any well-baby check-up at which the mother is present prior to the infant's first birthday.”181 illinois reimburses providers on a fee-for-service basis. the reimbursement rate for a screening is $14.60.182 the state of illinois does not allow for other caregivers besides the mother to be screened.183 if a mother screens positive for maternal depression, providers can offer information on resources and referral services.184 6. ohio ohio recommends screenings during well-child visits as medically necessary.185 services are available for caregivers of children on medicaid who are reimbursed at a rate of $3.43 per screening.186 if a mother screens positive for depression, they are offered enhanced care, including wraparound.187 ohio is one of the bottom ten states for infant mortality. with a death rate of 7.3 infant fatalities per 1,000 live births, ohio is ranked at forty-first.188 since 2016, ohio has put a heavy focus on improving its infant health outcomes. the ohio provision of enhanced maternal care services was created by their medicaid office in june 2016 and called for improvement on support and care for all ohio medicaid mothers and babies.189 179. id. 180. id. 181. id. 182. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 183. id. 184. id. 185. id. 186. ohio rev. code § 5167.17 (2021); see generally ohio dep’t of medicaid, guidance for managed care plans: provision of enhanced maternal care services 2 (2016), https://medicaid.ohio.gov/portals/0/providers/providertypes/managed%20care/provision-forenhanced-maternal-care.pdf [https://perma.cc/zrj3-9s6g]. 187. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146; see § 5167.17. 188. ohio summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/oh?editionyear=2019 [https://perma.cc/mt6k-zceu]. 189. see ohio dep’t of medicaid, supra note 186. 2021] minding baby 391 7. tennessee in the past three years, tennessee has seen an increase in infant mortality rates.190 in 2019, the infant mortality rate in tennessee matched that of indiana at 7.4 deaths per 1,000 live births.191 a low estimate is that 15.4 percent of mothers in tennessee are diagnosed with postpartum depression.192 in response, tennessee added mental health and maternal depression as a key strategy to their tenncare quality improvement plan.193 tennessee recommends that all mothers be screened for maternal depression at well-child visits.194 other caregivers are allowed to be screened as well, as long as they are a tenncare member.195 reimbursement rates are not made clear for screenings.196 providers are able to offer referral follow-up and guidance to mothers who screen positive for depression.197 8. west virginia the infant mortality rate in west virginia is slightly lower than in indiana at 7.2 deaths per 1,000 live births.198 policy in west virginia recommends that mothers are screened for depression at well-child visits.199 in 2012, west virginia added maternal depression screenings to its home visitation program.200 the policy allows for mothers to be screened up to four times within the first 120 days 190. tennessee summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/tn?editionyear=2019 [https://perma.cc/q3ej-85af]. 191. id. 192. the importance of maternal depression screenings, tenn. just. ctr., https://www. tnjustice.org/importance-maternal-depression-screenings/https://www.tnjustice.org/importancematernal-depression-screenings/ [https://perma.cc/tnl2-yrwy] (last visited mar. 28, 2021). 193. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146; see generally div. of tenncare, 2019 update to the quality assessment and performance improvement strategy 8 (2019), https://www.tn.gov/ content/dam/tn/tenncare/documents2/2019updateofqualityimprovementstrategy.pdf [https://perma.cc/r4nf-8btr]. 194. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 195. id. 196. id. 197. id. 198. west virginia summary 2019, am. health rankings (2019), https://www. am er icash ea lth ran kin gs .o rg / explore/health-of -w omen -an d-ch ild ren /m easu re / imr_mch/state/wv?edition-year=2019 [https://perma.cc/6bvb-w8xt]. 199. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 200. benchmarks, w. va. dep’t health & hum. res. (dec. 5, 2012), https://www.wvdhhr. org/wvhomevisitation/pdf/wvhvp_benchmarks_2013.pdf [https://perma.cc/24xc-xauu]. 392 indiana health law review [vol. 18:371 of their infant’s life.201 the reimbursement rate is $2.78 per screening and providers are able to offer follow-up and referral services.202 9. alabama in 2017, alabama medicaid added maternal depression screenings as a reimbursable test during well-child visits.203 the screenings are reimbursable through medicaid code 96161, which allows for the “[a]dministration of caregiver-focused health risk assessment instrument.”204 alabama does not give specific guidelines on when or how many times the screenings can be provided during well-child visits.205 postpartum depression in alabama has been on the rise jumping from 16.3 percent in 2018 to 19.9 percent in 2019.206 infant mortality has remained steady in the state moving up only slightly from 8.5 deaths per 1,000 live births in 2018 to 8.7 deaths per 1,000 live births in 2019.207 though still higher than the national average of 20 percent, alabama has seen a decrease in the percentage of children with two or more aces, dropping from 27.7 percent in 2018 to 26.3 percent in 2019.208 10. kentucky kentucky recommends maternal depression screening “as is medically necessary.”209 the reimbursement rate is $3.38, and there are no limits on how many screenings may be performed.210 caregivers other than the mother are also eligible for screening at the same reimbursement rate.211 in the case that a mother screens positive for depression managed care organizations “offer toolkits to 201. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 202. id. 203. id. 204. aap div. of health care fin., update on use of, payment for new health risk assessment codes, aap news (may 24, 2017), https://www.aappublications.org/news/2017/ 05/24/coding052317 [https://perma.cc/nsn9-9mrz]. 205. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 206. alabama summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/al?editionyear=2019 [https://perma.cc/y22v-chmk]. 207. id. 208. id. 209. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 210. id. 211. id. 2021] minding baby 393 providers with guidance for referral and follow up services.”212 kentucky ranks as thirty-six out of fifty states for infant mortality with 6.7 deaths per 1,000 live births.213 for aces, kentucky ranks in the bottom ten states with 25.8 percent of children screening positive for two or more aces.214 11. delaware delaware added a maternal mental health policy to its public health code in 2016, recommending that mothers be screened for depression during well-child visits.215 the legislation calls for the delaware division of public health to create educational materials regarding maternal depression.216 the statute further states that health care providers shall provide educational materials to mothers who present depressive symptoms.217 finally, the policy asserts that “health care provides shall begin evaluations and take action when they recognize symptoms of maternal depression in a woman or family.”218 health care providers are reimbursed through medicaid at a rate of $3.95 per screening.219 since 2017, infant mortality has been on the rise in delaware.220 the rate rose from 6.6 deaths per 1,000 in 2017 to 8.5 deaths per 1,000 in 2019.221 maternal mortality in delaware is lower than the national average at 16.9 deaths per 100,000 births.222 postpartum depression declined in the last year from 13.9 percent to 11.7 percent.223 12. district of columbia in 2018, the district of columbia (“dc”) created a maternal mental health task force.224 the task force was charged with identifying vulnerable 212. id. 213. kentucky summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/ky?editionyear=2019 [https://perma.cc/a7a6-bxfs]. 214. id. 215. del. code tit. 16, § 801d (2021); medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 216. tit. 16, § 801d. 217. id. 218. id. 219. medicaid policies for maternal depression screening (mds) during well-child visits, by state, supra note 146. 220. delaware summary 2019, am. health rankings (2019), https://www.americashealth rankings.org/explore/health-of-women-and-children/measure/imr_mch/state/de?editionyear=2019 [https://perma.cc/jy5m-vatl]. 221. id. 222. id. 223. id. 224. d.c. code § 7-1233.02 (2021). 394 indiana health law review [vol. 18:371 populations and risk factors, identifying barriers to screening and models for private and public funding for maternal mental health screening and treatment.225 infant mortality in dc is significantly higher than the national average at 8 deaths per 1,000 live births.226 the maternal mortality rate in dc is also much higher than the national average at 35.6 deaths per 100,000 live births.227 the maternal mental health task force will be able to collect data on maternal mental health and use that to create legislation to make screening and services more accessible. d. federal policy the bringing postpartum depression out of the shadows act was passed in 2016 and was the first time that congress recognized the importance of maternal mental health treatment.228 the act allows for the department of health and human services (“hhs”) to provide grant funding to states for the purpose of establishing maternal depression screening programs or educational programs.229 the law provides that states that propose programs to enhance access to screening will be given priority.230 the act also allows for funding to be used for educating and training physicians on maternal mental health disorders.231 further, the centers for medicaid and medicare services authorized state agencies to provide maternal depression screenings as a service for children at well-child visits reimbursable under epsdt, to which all children covered on medicaid are entitled.232 in 2018, minnesota was awarded a block grant through this act, which allocated funds to provide screening and home-based services for perinatal mood and anxiety disorders.233 the grant allows for services to extend up to the first year of the child’s life.234 the grant money comes from hhs and can be used for “establishing new screening or treatment programs, or [to] expand or maintain existing screening or treatment programs.”235 the commissioner is responsible for determining who is eligible for use of the money and is mandated by the statute 225. id. 226. district of columbia summary 2019, am. health rankings (2019), https://www. am er icash ea lth ran kin gs .o rg / exp lore /h ea lth-of-women-and-ch ild ren /m easu re / imr_mch/state/dc?edition-year=2019 [https://perma.cc/5kxc-zhry]. 227. id. 228. caroline bologna, congress passes groundbreaking postpartum depression legislation, huffpost (dec. 7, 2016), https://www.huffpost.com/entry/congress-passes-groundbreakingpostpartum-depression-legislation_n_584053a6e4b09e21702d2a43 [https://perma.cc/2945-847k]. 229. 42 u.s.c. § 247b-13a (2020). 230. id. 231. id. 232. the importance of maternal depression screenings, supra note 192. 233. see minn. stat. § 145.908 (2021). 234. id. 235. id. 2021] minding baby 395 to prioritize screening and assessment of maternal mental health.236 v. recommendations for indiana policy though indiana is taking steps towards combating the high infant mortality rate, very little is being done regarding maternal mental health. as a state, indiana needs to recognize that maternal mental health and trauma play a significant role in the health of both mother and baby. policy needs to be enacted that will address the significance of maternal depression in the fight against infant and maternal mortality and will provide services for screening and treatment of maternal mental health. indiana should model its code after surrounding states that have adopted mandatory or recommended screening protocol. all mothers enrolled in medicaid or the healthy indiana plan (also known as hip, indiana’s medicaid expansion) should be screened for postpartum depression. policy should include a plan for reimbursement for the screening. like the texas statute, indiana should allow for mothers who are not covered under medicaid or hip, but whose babies are, to still be covered for purposes of screening up to the infant’s first birthday. once mothers have been screened, if diagnosed with maternal depression, services should be provided to treat the symptoms and offer support. services offered by the ob navigator program should be utilized as means of support for mothers struggling with depression. there are several services that already work in indiana that could potentially be leveraged for wraparound services.237 many of these organizations are already working with the ob navigator program and therefore would be easy to incorporate into mental health wraparound services. vi. conclusion current indiana policy surrounding maternal health addresses many important aspects of physical health, but largely disregards the importance of mental health. unlike many surrounding and similarly situated states, indiana does not require, recommend, or even allow for reimbursement for maternal depression screenings during well-child visits. this ultimately is causing significant costs to the state both socially and financially. there is a significant financial cost to ignoring maternal mental health. maternal mental health affects more than just the mother. for each infant born preterm, with birth defects, or birth complications, an estimated $93,800 is spent on health care for the child’s first year of life with most of that cost being borne 236. id. 237. some of these services include evidence practices that are endorsed by the indiana state department of health such as healthy families indiana and the nurse-family partnership. both organizations are home-visit based and serve elkhart, grant, lake, laporte, st. joseph, scott, delaware, madison, and marion through funding from the maternal, infant, & early childhood home visiting program. see maternal, infant, & early childhood home visiting (miechv) program, ind. dep’t health, https://www.in.gov/isdh/25565.htm [https://perma.cc/h4vb-8r8b] (last visited mar. 29, 2021). 396 indiana health law review [vol. 18:371 by medicaid.238 life-long adverse outcomes are possible for the infant. the ultimate cost of ignoring maternal mental health is too high. by shedding light on the reality of maternal depression and the effect of trauma on maternal health, indiana can become a national leader in maternal and infant health, and ultimately lower the infant and maternal mortality rate. nearby states, as well as states that (like indiana) are ranked in the bottom ten for infant mortality rates, have all taken action to combat maternal depression. if indiana is serious about lowering the infant mortality rate in this state it is time to follow the lead of other states, as well as the aap’s screening recommendations, which encourage screening medicaid mothers for maternal depression. 238. how much does infant mortality cost the nation, nat’l healthy start ass’n (2015), http://www.nationalhealthystart.org/healthy_start_initiative/how_much_does_infant_mortality_ cost#:~:text=those%20babies%20that%20survive%20the,smallest%20survivors%20will%20av erage%20%24273%2c900 [https://perma.cc/jn78-wutx]. indiana health law review volume xvi 2019 number 2 article law and policy approaches to sex-based disparities in musculoskeletal health care frank griffin, m.d., j.d.* abstract women’s health care law and policy discussions tend to focus on reproductive health and breast cancer, but there are significant disparities involving other physiologic systems—like the musculoskeletal system. failure to recognize sex-based differences in health and in health care leads to inequalities in delivery and outcome of medical care—especially negatively impacting young, active girls and women, as well as adult and aging women. for example, in sports medicine, female athletes are two to eight times more likely to tear their acl (knee) than their male counterparts participating in the same sports and to have worse outcomes after surgical repair. similarly, older women are more likely to need knee replacement and to do poorly after surgery. male bias and male norm historically built into musculoskeletal care and research likely contribute to disparities. only around 6% of practicing orthopedic surgeons are women. physicians and other providers are generally under-educated in sex-based differences involving the musculoskeletal system and typically deliver care in a gender-neutral manner, which leads to disparities disproportionately affecting women. the causes of disparities are multifactorial and complex with strong influences of biological and social/cultural factors playing a role, which are discussed in this paper. interdisciplinary approaches involving medical providers, medical educators, medical researchers, lawmakers, policymakers and courts are discussed to address this emerging and important issue. continuing to acknowledge and embrace sex-based differences in musculoskeletal medical care will lead to improvements in the health and health care for everyone. introduction an individual’s sex plays an important role in his or her experience of disease and injury—all disease and injury . . . not just that associated with reproductive organs; male and female cells have basic chromosomal differences leading to * dr. frank griffin, m.d., j.d., is the health law scholar-in-residence and adjunct professor at the university of arkansas school of law and is an adjunct assistant clinical professor, division of orthopedic surgery, university of arkansas for medical sciences. 252 indiana health law review [vol. 16:251 sexual dimorphism that make them respond differently to their environment causing disparities in health and health care.1 these differences are present across organ systems throughout the whole body; yet women’s health research and regulation have historically focused on “women’s health issues” as those related to the reproductive system (e.g., childbirth) or “women’s diseases” (e.g., breast cancer) with the assumption that sex differences in other organ systems could be explained by differences in height, weight, etc.2 biological, psychological, socioeconomic, and cultural factors interact to cause differences in health and health care for men and women.3 recognition of sex-based differences in the medical needs of patients leads to improvement of health care delivery and outcomes.4 medical teaching, treatment, and research outside of reproductive medicine have traditionally been gender-neutral5 1. inst. of med., exploring the biological contributions to human health: does sex matter? 1 (2001), http://www.nationalacademies.org/hmd/~/media/files/report%20files/ 2 0 0 3 /e xplor in g-th e-b io log ica l-c o n t r ib u t io n s t o -h u m a n -h e a lth -d oes -sexmatter/doessexmatter8pager.pdf [https://perma.cc/8bfw-j6gm] (“evidence suggests that the distinct anatomy and physiology that develop as a result of having been dealt two x chromosomes (xx) or an x chromosome and a y chromosome (xy) at fertilization can have a much broader influence on an individual’s health than was previously thought.”); see also laura l. tosi et al., does sex matter in musculoskeletal health? the influence of sex and gender on musculoskeletal health, 87-a j. bone & joint surgery 1631, 1631-32 (2005), http://citeseerx.ist.psu.edu/ viewdoc/download?doi=10.1.1.819.9234&rep=rep1&type=pdf [https://perma.cc/4fpf-y5wy] (“[a] male cell is not the same as a female cell, and sex chromosome-linked genes can be expressed differently in cells from all organ systems.”); see also cordelia w. carter et al., sex-based differences in common sports injuries, 26 j. am. acad. orthopeadic surgeons 447, 447 (2018) https://pdfs.journals.lww.com/jaaos/2018/07010/sex_based_differences_in_common_sports_i njuries.1.pdf?token=method|expireabsolute;source|journals;ttl|1547483647280;payload|my8d 3u1tccsnvp5e421jyk6n6xicdamxbyyypanzk7fkjtaa1yz22mivkhzqjgp4kds2v0j76w ganhach69s21csk0opqi3ybjemdsoz2uhvybfqqxa7lkwsula502zqzr96tqrwhvloce p/sj586avbcbflltknko+tbumfl73hipqjliudqs17chelclbv/cqjlp3io0jghlhqtjwcicdday gjmnpi6rlbejarhegeh5z5uvqz3flhgpkvxjzd/9s7nivsi/te1ihgtttbj3ix3uzku6/hxszyybr m23o=;hash|ulk+fgqoykp1fjlntegwoa== [https://perma.cc/pbn5-4xpr] (“the patient’s sex plays an important role in mediating the risk for, and experience of, disease.”). 2. tosi et. al., supra note 1, at 1631 (noting that women had been presumed to be “little men” and that in spite of calls to broaden the study, even the institute of medicine’s iom’s 2011 report “did not include any musculoskeletal health issues.”). 3. halime h. celik et al., gender sensitivity among general practitioners: results of a training programme, 8 bmc medical educ. 1, 1-2 (2008), https://bmcmededuc. biomedcentral.com/track/pdf/10.1186/1472-6920-8-36 [https://perma.cc/l9b2-xst2] (“differences between men and women in health depend on the interaction of biological, psychological, socio-economic, and cultural factors.”). 4. id. at 2 (“recognition of gender differences can prevent inequity in caregiving [and] . . . . [a]s a result the health of women and men can be improved.”). for specifics, see remainder of this paper. 5. id. (pointing out that sex-based differences in treatment remain underdeveloped and most 2019] sex-based disparities in musculoskeletal health care 253 —especially in fields like musculoskeletal medicine. failure to adjust medical care based on sex can lead to disparities, especially among women.6 many musculoskeletal diseases and injuries have sex-based differences. anterior cruciate ligament (acl) tears, osteoarthritis, ankle sprains, osteoporosis, hip & wrist fractures, spinal disorders, severe scoliosis, and many other musculoskeletal problems are more prevalent among women than men.7 sexbased differences in injury mechanism, pain sensation, drug handling by the body, and healing responses have also been noted and can lead to differences in responses to treatments like surgery, anesthesia, pain medication, pharmaceuticals, and rehabilitation.8 therefore, health care professionals need to be “sex sensitive” to optimally treat both sexes.9 law and policy measures can sometimes unintentionally complicate medical care by making medical professionals uneasy and perhaps less likely to acknowledge or address non-obvious sex-based differences to avoid the appearance of sex stereotyping or of treating the sexes unequally in a socially and politically charged environment. section 1557 of the affordable care act (“aca”) “prohibits discrimination on the grounds of . . . sex . . . in certain health programs and activities” with the “final rule appl[ying] to any health program or activity, any part of which receives funding from” entities funded by the department of health and human services (“hhs”), like medicare and medicaid10—virtually including all health care activities, including doctor and hospital interactions with patients. “the rule makes clear that sex discrimination prohibited under section 155711 includes discrimination based on . . . sex stereotyping.”12 sex stereotypes means stereotypical notions of masculinity or femininity, including expectations of how individuals represent or communicate their clinical practice guidelines remain gender neutral failing to cover gender issues related to diagnosis/treatment). for problems with gender neutral medicine, see infra pp.19-26. 6. see generally inst. of med., supra note 1. 7. tosi et al., supra note 1, at 1632 tbl. i; carter et al., supra note 1, at 347 (observing differences in rates of acl tears, stress fractures, and other sports-related injuries). 8. tosi et al., supra note 1, at 1632 (“responses to therapy (e.g., surgery, anesthesia, pain medication, pharmaceuticals, and rehabilitation) also differ with sex.”); carter et al., supra note 1, at 347-48 (noting differences in outcomes of acl surgery based upon type of graft chosen). 9. celik et al., supra note 3, at 1. 10. section 1557: protecting individuals against sex discrimination, dep’t of health & human servs., https://www.hhs.gov/civil-rights/for-individuals/section-1557/fs-sexdiscrimination/index.html [https://perma.cc/7lyx-wbk5]. see 45 c.f.r. § 92.1 (2018); 42 u.s.c.a. § 18116 (2018); 20 u.s.c.a. § 1681 (2018) (“on the basis of sex”). 11. patient protection and affordable care act, 42 u.s.c.a. § 18116, sec. 1557 (2010). 12. dep’t of health & human servs., section 1557: protecting individuals against sex discrimination, https://www.hhs.gov/sites/default/files/1557-fs-sex-discrimination-508.pdf [https://perma.cc/fu57-3mfw]. 254 indiana health law review [vol. 16:251 gender to others, such as . . . body characteristics. these stereotypes can include the expectation that individuals will consistently identify with only one gender and that they will act in conformity with the genderrelated expressions stereotypically associated with that gender.13 the inclusion of “body characteristics” in the definition above could arguably create some issues and potential claims of discrimination against medical providers considering differences between the sexes’ body characteristics noted below. sex stereotyping is defined by at least one legal author as “a form of discrimination rooted in conformist notions of appropriate behavior, appearance or mannerisms for each gender.”14 some musculoskeletal biologic differences discussed below could arguably be construed as forms of sex stereotyping; for example, the idea that women’s bones are smaller and ligaments more lax could be construed as signs of “weakness” or being the “weaker sex.” in addition, hhs says that “[w]omen must be treated equally with men in the health care they receive . . . ”15 “sex-specific health programs or activities are permissible only if the entity can demonstrate an exceedingly persuasive justification, that is, that the sex-specific health program or activity is substantially related to the achievement of an important health-related or scientific objective.”16 however, sometimes in medicine, “equally” may not mean “the same”; in other words, to achieve equal outcomes, physicians may need to treat patients differently (i.e., arguably “unequally”) based upon sex as outlined below. medicine is constantly evolving, treatments are changing as research emerges (sometimes contradicting prior consensus), and some treatments are based upon long-standing consensus that arguably may or may not be supported by “exceedingly persuasive justification”—such as a randomized, controlled, clinical trial. further complicating evaluation and management of sex-based differences is an ongoing redefinition of “sex” and “gender” in the medical literature. the institute of medicine (“iom”) defined “sex” as “the classification of living things, generally as male or female according to their reproductive organs and functions assigned by chromosomal complement,” which researchers consider to be biologic.17 the iom defined “gender” as “a person’s self-representation as male or female, or how that person is responded to by social institutions based on the individual’s gender presentation.”18 the iom notes that “[g]ender is rooted 13. 45 c.f.r. § 92.4 (2016) (emphasis added). 14. kevin costello & maryanne tomazic, on sex discrimination in health care, the pendulum swings with severity, health aff. blog (jan. 22, 2018), https://www.healthaffairs.org/ do/10.1377/hblog20180122.689768/full/ [https://perma.cc/p6bb-bgfs]. 15. dep’t of health & human servs., supra note 12. 16. id. (emphasis added). 17. inst. of med., supra note 1, at 1. 18. id. 2019] sex-based disparities in musculoskeletal health care 255 in biology and shaped by environment and experience.”19 the law adds additional layers of complexity on the definition of gender and handling of sex-based differences in medical care. the rule from section 1557 of the aca defines gender identity as follows: gender identity means an individual's internal sense of gender, which may be male, female, neither, or a combination of male and female, and which may be different from an individual's sex assigned at birth. the way an individual expresses gender identity is frequently called “gender expression,” and may or may not conform to social stereotypes associated with a particular gender.20 hhs initially enacted rules including gender identity in the definition of sex discrimination in title ix. however, the rule was found to be “contrary to law” and “exceed[] statutory authority,” so “the prohibition of discrimination on the basis of ‘gender identity’” was enjoined.21 the court explained: prior to the passage of the aca in 2010 and for more than forty years after the passage of title ix in 1972, no federal court or agency had concluded sex should be defined to include gender identity. accordingly, hhs's expanded definition of sex discrimination exceeds the grounds incorporated by section 1557.22 these definitions and rulings can impact delivery of health care by providers. sex plays an important role in musculoskeletal health. sex and gender include an “array of socially constructed roles, behaviors and values that society ascribes to the two sexes on a differential basis.”23 this paper is intended to address differences in biologic sex determined at birth by chromosomal makeup, and will therefore use the term “sex” instead of “gender” throughout—even though some of the studies cited use the term “gender” synonymously with “sex.” the focus of this paper is policy and legal ways to address the largely ignored “sex-based differences in cell biology, tissue function, and disease presentation and management” that musculoskeletal experts agree have the potential to affect medical and surgical treatment recommendations in the area of musculoskeletal health care.24 in part i, some common sex-based disparities in musculoskeletal care are discussed. in part ii, the potential causes of sex-based disparities are explored—including biologic, societal and cultural, and medical community biases. in part iii, potential solutions to gender disparities in musculoskeletal care 19. id. 20. 45 c.f.r. § 92.4 (2016). 21. franciscan alliance, inc. v. burwell, 227 f. supp.3d 660, 695 (n.d. tex. 2016). 22. id. at 689. 23. celik et al., supra note 3, at 1-2. 24. tosi et al., supra note 1, at 1643 (“this workshop unambiguously concluded that there are indeed sex-based differences in cell biology, tissue function, and disease presentation and management with the potential to affect how orthopaedic surgeons manage their patients.”). 256 indiana health law review [vol. 16:251 are explored. i. gender disparities in musculoskeletal care many musculoskeletal diseases have different prevalence, treatment, and/or outcomes based upon sex (i.e., there is a sexual dimorphism). disparities disfavoring women are present in sports and military training, in arthritis treatment regimens, as well as in many other areas of general musculoskeletal care. in addition, some disparities are present that disfavor men in musculoskeletal care. this section includes is a partial listing of some representative examples of musculoskeletal sex-based disparities. other disparities have been identified, and many more likely have not yet been discovered due to limited research in this area. a. disparities disfavoring young, active girls and women women are “at an increased risk of musculoskeletal injury during sport and military training.”25 a few representative examples of known disparities include knee injuries involving the anterior cruciate ligament (acl), other ligamentous injuries involving other joints, stress fractures, concussions, and fractures due to intimate partner violence (ipv). first, many ligament injuries, sprains, and tears are more prevalent among females than males. the acl is an important stabilizing ligament in the center of the knee, and an acl tear usually leads to surgery and an extended absence from sports-related activity. acl tears are most common among young athletes in cutting sports like basketball and soccer.26 female athletes are particularly vulnerable to rupture of the acl with an incidence of noncontact acl injuries that is two to eight times higher than males participating in the same sports.27 in addition, female athletes respond disparately to surgery compared to males, with females being less likely to return to sport than males after acl reconstruction surgery.28 some other ligament injuries involving the shoulder and ankle are also more prevalent among females. females have higher rates of atraumatic multidirectional shoulder instability than in males.29 women sustain ankle sprains almost twice as commonly as men, and female athletes have higher rates of 25. christopher m. daniels et al., gender disparities within us army orthopedic surgery: a preliminary report, 183 mil. med. e162, e162 (2018). 26. jennifer moriatis wolf et al., male and female differences in musculoskeletal disease, 23 j. am. acad. orthopaedic surgeons 339, 339 (2015). 27. carter et al., supra note 1, at 449. 28. wolf et al., supra note 26, at 341 (observing that “[a]fter acl reconstruction, women are less likely to return to sport than men.”). 29. carter et al., supra note 1, at 450 (discussing atraumatic shoulder instability); see also, wolf et al., supra note 26, at 341 (explaining that “[m]ultidirectional shoulder instability (mdi) is thought to occur more commonly in women.”).”). 2019] sex-based disparities in musculoskeletal health care 257 chronic ankle instability in high school and college than male athletes.30 second, stress fractures are more common in females than in males. in military personnel, females sustain three times more stress fractures than males.31 in female athletes, the incidence of stress fractures is 9.7% compared to 6.5% in male athletes.32 third, possibly due to musculoskeletal issues discussed below, “female athletes sustain markedly more concussions than male athletes” participating in the same sport.33 some studies reveal that female athletes are twice as likely as male athletes in similar sports to sustain a concussion.34 in addition, some authors have shown that “female athletes sustain more severe concussions than do males, with greater deficits in cognitive function reported and a longer recovery period required than their male counterparts.”35 finally, women with broken bones or fractures are more likely to be the victims of intimate partner violence (ipv). musculoskeletal injuries are one of the most common manifestations of ipv, which is the “leading cause of non-fatal injury to women worldwide.”36 one in six women orthopaedic fracture clinic patients disclosed a history of ipv within the previous year, and one in three had experienced ipv within their lifetime.37 almost 2% (1/50) of women in orthopaedic fracture clinics attended their visit as a direct result of ipv, but only 14% of them were ever asked about ipv in a health care setting. 38 b. disparities disfavoring adult and aging women degenerative arthritis of the knee, hip and back are common among adults of both sexes, but disparities are present with regard to the experience of these diseases based upon sex. in addition, older women disproportionately experience osteoporosis and several other diseases. first, disparities in knee osteoarthritis are present. knee osteoarthritis (oa) is a leading cause of disability in the united states affecting up to 6% of 30. tosi et al., supra note 1, at 1637 (noting higher prevalence of ankle sprains among women); wolf et al., supra note 26, at 341 (noting “women have higher rates of chronic ankle instability . . .”). 31. carter et al., supra note 1, at 448. 32. laurel wentz et al., females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review, 176 mil. med. 420, 423 (2011). 33. carter et al., supra note 1, at 452. 34. id. 35. id. 36. praise investigators, prevalence of abuse and intimate partner violence surgical evaluation (praise) in orthopaedic fracture clinics: a multinational prevalence study, 382 lancet 866, 866 (2013). 37. id. 38. id. 258 indiana health law review [vol. 16:251 americans and is up to twice as common in women as men.39 women tend to experience knee osteoarthritis differently than men. women wait longer to present to orthopaedic surgeons for consideration of total knee replacement (tkr) surgery evidenced by the fact that women have a “higher burden of disease, greater pain, and [greater] functional impairment” at the time of their total knee replacements than men.40 women have about 40% more total knees than men, but some researchers suggest that the overall need for tkr among women is around three times as high as in men.41 in addition, disparities persist after tkr surgery. women “do not appear to recover to the same level as men following” knee replacement and have worse functional outcomes, more pain after surgery, more use of opioid pain medication, and less range of motion.42 similar disparities may be present when it comes to hip replacement surgery, but data are confounded by hip replacement surgeries performed for hip fracture (which occur more frequently in women), instead of osteoarthritis, making analysis more difficult.43 second, sex-based disparities in the treatment of degenerative back problems are evident. women have a worse functional status before undergoing some spine surgeries (e.g., laminectomy for spinal stenosis) than men and are operated 39. atul f. kamath et al., ethnic and gender differences in the functional disparities after primary total knee arthroplasty, 468 clinical orthopaedics related res. 3355, 3355 (2010) (observing that knee oa is a leading cause of disability and has a 6% prevalence); jeffrey n. katz et al., differences between men and women undergoing major orthopedic surgery for degenerative arthritis, 37 arthritis rheumatism 687, 688 (1994) (noting that women “have a 1.5-2.0-fold higher incidence of knee osteoarthritis”). 40. wolf et al., supra note 26, at 343-44 tbl. 1 (stating that some studies show that women have more pain before surgery); katz et al., supra note 39, at 693 (observing specifically, women have more advanced osteoarthritis and much worse functional status prior to tkr than men immediately prior to tkr suggesting that doctors or patients put off tkr longer in women than in men). 41. katz et al., supra note 39, at 688 (“the age-adjusted frequency of total knee arthroplasty is approximately 40% higher in women than in men.”); jasvinder a. singh et al., gender and surgical outcomes after primary total knee arthroplasty, 65 arthritis care & res. 1095, 1010 (2013), (“although age-adjusted rates of tja are higher for women, the overall need for arthroplasty is three times greater for women compared to men.”); see also kamath et al., supra note 39, at 3358 (proclaiming an “underuse” of tkr in women). 42. wolf et al., supra note 26, at 343-44 (observing that compared to men after tkr, women have worse functional outcomes and higher dependence on gait aids with female gender being a “predictor of moderate to severe functional limitation at 2 and 5 years” and that some studies show that women have more pain after surgery and more use of opioid pain medication at 2 and 5 years); see also kamath et al, supra note 39, at 3359 (explaining women have worse functional outcomes after tkr with regard to postop range of motion). 43. katz et al., supra note 39, at 688 (“similarly, the age-adjusted frequency of total hip arthroplasty is approximately 30% higher in women, but these data include arthroplasty for hip fracture, which occurs much more frequently in women.”). 2019] sex-based disparities in musculoskeletal health care 259 on at a more advanced state of the disease.44 researchers concluded that the disparities are not “due to gender differences in demographic or clinical characteristics of the patients, and cannot be justified by differences between men and women in the outcome of surgery.”45 females are also eight times more likely to have scoliosis severe enough to require medical intervention, often including back surgery.46 third, women disproportionately experience osteoporosis and fragility fractures associated with osteoporosis. osteoporosis in the u.s. in persons who are at least 50 years of age is four times more common in women than men.47 the risk of hip fracture is three times higher in women than in men based on age and other risk fractures.48 fragility fractures of the distal radius in the wrist are six times more common in women than men.49 finally, other musculoskeletal diseases with increased prevalence among females include frozen shoulder (i.e., adhesive capsulitis),50 lumbar disc degeneration, lupus (9:1), sjogren syndrome (9:1), graves disease (9:1), hashimoto thyroiditis (10:1), hip dysplasia, metastatic bone cancer,51 rotator cuff tears, bunions (i.e., hallux valgus), and some musculoskeletal tumors.52 c. disparities disfavoring men not all musculoskeletal health and health care disparities disfavor females. many musculoskeletal disparities disfavor males—including boys and young active men, as well as adult and aging men. first, several disparities disfavor boys and young active men. males participating in sports “are markedly more likely than females to sustain acute, traumatic injuries such as . . . fractures.”53 overall, boys more frequently suffer 44. id. at 687. 45. id. 46. scoliosis, am. ass’n neurological surgeons, https://www.aans.org/patients/ neurosurgical-conditions-and-treatments/scoliosis [https://perma.cc/686e-b5zt] (“females are eight times more likely to progress to a curve magnitude that requires treatment.”). 47. wolf et al., supra note 26, at 341 (observing osteoporosis as it is present in 16% of women compared to 4% in men). 48. id. (noting post-menopausal osteoporosis related to estrogen deficiency is linked to hip fracture occurrence). 49. id. at 342 (explaining females have a “6:1 preponderance of age-related increases in wrist fractures compared with males.””). 50. tosi et al., supra note 1, at 1632 tbl. 1. 51. id. at 1641. 52. tosi et al., supra note 1, at 1632 tbl. i; see also elizabeth matzkin et al., does sex matter in orthopedic care?, 19 orthopedic j. harv. med. school 38, 39 tbl.29 (table 1 (2018). 53. carter et al., supra note 1, at 447 (also noting that studies support the finding that females are more likely to sustain overuse injuries, like stress fractures and patellofemoral pain, whereas males are more likely to sustain acute traumatic injuries, like fractures or traumatic dislocations). 260 indiana health law review [vol. 16:251 sports-related injuries (sris) than girls with males sustaining 71% of the sris and having higher injury rates in 11 of the 13 sports studied.54 traumatic shoulder dislocations and instability, including likelihood of recurrence, is more common (i.e., traumatic shoulder dislocations are more than twice as common) in male athletes than female athletes.55 when it comes to hip injuries, males are much more likely to develop femoroacetabular impingement (fai) than females.56 even though females are more likely statistically to sustain an acl tear, the absolute number of males having acl tears is higher than females because the absolute number of males participating in sports in general is higher.57 while female basketball players are more likely to sustain acl tears, male basketball players are more likely to have osgood-schlatter disease and jumper’s knee (patellar and femoral tendinopathy).58 male players are also almost twice as likely to have an upper extremity injury as female athletes.59 second, several disparities disfavor adult and aging men. men are more likely suffer from traumatic injuries like broken bones and traumatic dislocations60 in addition, men have worse outcomes after hip fractures, including increased morbidity and twice the mortality of women.61 osteoporosis has been poorly 54. id. 55. id. at 450 (observing in one study, researchers found males were 2.6 times more likely to “present to the emergency department with a shoulder dislocation than are females.”); elizabeth matzkin, sports medicine experts highlight sex-based differences in common sports injuries, healio: orthopedics today (july 24, 2018), https://www.healio.com/orthopedics/sportsmedicine/news/online/%7b57a1eb08-f160-4a9d-b2ea-8377803dafa6%7d/sports-medicine-expertshighlight-sex-based-differences-in-common-sports-injuries [https://perma.cc/36a8-qxnh]. 56. andrea halim et al., the importance of sex of patient in the management of femoroacetabular impingement, 44 am. j. orthopedics 172, 174 (2015), https://www. amjorthopedics.com/sites/default/files/issues/articles/ajo0440172.pdf [https://perma.cc/7mxk9hb6]. 57. carter et al., supra note 1, at 449 (“therefore, given the higher rate of sports participation among males, the absolute number of acl injuries remains higher for this group than for female athletes.”). 58. eri ito et al., sex-specific differences in injury types among basketball players, 6 open access j. sports med. 1, 2 tbl. 1 (2015) (noting for osgood-schlatter’s disease rates of 12.5% males vs. 1.8% females in 10-19 y/o age group and 14.6% males vs. 3.7% females in the 20-29 y/o age group). 59. id. at 2 tbl. 2 (noting rates of upper extremity injuries of 9.7% in males vs. 5.1% in females). 60. rebecca mitchell et al., understanding trauma as a men's health issue: sex differences in traumatic injury presentations at a level 1 trauma center in australia, 19 j. trauma nursing 80, 80 (2012) (observing that “males had a higher proportion of trauma presentations,” that males were four times more likely to be victims of assault (8% vs. 2%), that males were more likely to be severely injured, and that males were more likely to be injured while working and during leisure activities). 61. wolf et al., supra note 26, at 342 (observing male sex increases the risk of death (mortality) significantly after hip fracture and that there is “excess mortality after hip fractures in 2019] sex-based disparities in musculoskeletal health care 261 studied in men,62 so there is a significant gender gap in diagnosis and treatment of osteoporosis with around 90% of men with osteoporosis going untreated after fragility fractures.63 similarly, only 1.2% of male veterans in the va system underwent bone mineral density testing.64 failure to diagnose osteoporosis in males has important implications to prevent future fractures and to improve longevity.65 with regard to cancer, men experience “60% more primary musculoskeletal tumors than females.”66 other musculoskeletal diseases with an increased prevalence among males include goodpasture syndrome (3:1), rheumatoid arthritis (3:2), malignant hyperthermia (including prolonged recovery), legg-calve-perthes disease, osteoid osteoma (3:1), trauma, clubfeet, dupuytren’s contracture (hand), and sepsis.67 it is important to note that men die at greater rates than women for almost all of the leading causes of death in the united states—including all twelve of the leading causes of death—and often from preventable causes.68 regarding health in general, men have significantly shorter life spans than women, which may be the result of societal expectations including engaging in riskier jobs, military service, etc.69 some of these same issues may contribute to disparities disfavoring males in musculoskeletal health. ii. causes of gender disparities in musculoskeletal care causes of gender disparities in musculoskeletal health and health care include issues involving the medical community, biological differences between the sexes, and sex-based cultural and societal differences. a. medical community issues leading to disparities in musculoskeletal care, male norm and male bias may cause disparities due to the lack of sex-based diversity in orthopedics and due to the sex-based bias built into research studies historically. in addition, lack of physician education regarding sex-based differences may play a role. men compared with women” in all age groups). 62. id. 63. id. (noting only 10.3% of canadian men were treated for osteoporosis after fragility fracture). 64. id. 65. id. 66. tosi et al., supra note 1, at 1641. 67. id. at 1632 tbl. 1. see also matzkin et al., supra note 52, at 39. 68. shari l. dworkin, masculinity, health and human rights: a sociocultural framework, 33 hastings int'l & comp. l. rev. 461, 464 (2010). 69. id. (explaining men “die nearly seven years younger than women in the u.s.”). 262 indiana health law review [vol. 16:251 1. male norm male norm is the tendency to use men as the standard in studies that involve disease affecting both sexes.70 as explained below, musculoskeletal research, like much of medical research, has historically disproportionately used male subjects and applied findings across the sexes. when research is performed using predominantly male subjects in areas with sex-based differences, the male response is seen as the “norm,” and the female response is seen as “deviant” or abnormal.71 historically, sex-based disparities developed in research studies because females were considered vulnerable and complex. the nuremburg code (1949) and the declaration of helsinki (1964) protected human subjects involved in medical research.72 tragedies linked to the use of diethylstilbestrol and thalidomide in pregnant women in the 1950s and 1960s led to classification of women and unborn children as “vulnerable populations,” such that the fda established a policy excluding pregnant women and potentially pregnant women from phase-i clinical studies unless research on potential fetal toxicity had been completed.73 in addition, female hormonal cycles created an additional set of variables that made research study design and data analysis more complicated, so researchers primarily studied males as representative of the entire human population.74 this led to a sampling error with a predominance of male specimens in clinical trials.75 because there was a general belief that men and women did not differ significantly in their responses to treatments, researchers did not correct for this sampling error.76 in 1985, just eight years after the fda’s guidelines were established, the united states public health service task force on women’s health issues found that lack of research on women’s health issues was compromising women’s health care.77 due to research bias, male responses had “subtly came to be seen as the ‘norm’ and female responses as ‘deviant or problematic.’”78 in 1986, the nih, in response to this report, issued guidelines encouraging researchers to include women in federally funded clinical research projects—but not requiring 70. tosi et al., supra note 1, at 1643. 71. id. at 1642. 72. id. 73. id. 74. id. 75. id. 76. id. 77. id. (stating “a report from the united states public health service task force on women’s health issues concluded that women’s health care was compromised by lack of research on women’s health issues” and citing united states public health service task force on women’s health issues (task force). task force, report of the public health service task force on women’s health issues, 100 pub. health rep. 73 (1985)). 78. id. 2019] sex-based disparities in musculoskeletal health care 263 women’s inclusion.79 the general accounting office (gao) found in 1990 that these guidelines were not being followed.80 finally, in 1993, the nih revitalization act of 1993 mandated the inclusion of women in clinical trials and established the office of research on women’s health (orwh), while the fda rescinded its policy excluding women from phase-i trials.81 in 1998, the fda “announced that it would refuse to file any new drug application that did not include enough women to assess safety and efficacy on the basis of sex.”82 while statistics are not available specifically for musculoskeletal disorders in an iom report, overviews of studies involving other types of diseases are telling.83 for example, a 2012 report indicated that women “constituted less than 40% of participants” in cancer studies.84 similarly, research on cardiovascular disease is particularly male-biased with only 27% of participants being female in a cross-sectional analysis of 19 studies.85 historical underrepresentation of women in research studies has led to “male norm” playing a role in disparities negatively impacting women. 2. male bias musculoskeletal doctors are predominantly male—so, male thought processes and unconscious bias likely are present in musculoskeletal care. male bias is an observer error related to the adoption of a male perspective and habit of thought.86 physicians, like everyone else, stereotype patients by using “cognitive shortcuts” using social categories (like sex) in “acquiring, processing, and recalling information” about patients.87 cognitive shortcuts can be important for busy professionals to efficiently process, organize, and simplify complex medical 79. id. (citing dep’t of health & human servs., nih guide for grants and contracts., vol. 16., no. 3, 2 (u.s. government publishing office, 1987). 80. id. 81. tosi et al., supra note 1, at 1642 (citing guideline for the study and evaluation of gender differences in the clinical evaluation of drugs, 58 fed. reg. 39,406 (july 22, 1993); national institute of health revitalization act of 1993, pub. l. no. 103-43, 107 stat. 122 (1993) ( “in conducting or supporting clinical research for purposes of this title, the director of nih shall . . . ensure that—(a) women are included as subjects in each project of such research.”). 82. id. at 1643 (citing investigational new drug applications and new drug applications, 63 fed. reg. 6854 (feb. 11, 1998)). 83. theresa wiseman, sex-specific reporting of scientific research: a workshop summary 1 (the national academies press, 2012), https://genderedinnovations.stanford.edu/ sex%20specific%20reporting%20wizemann%202.pdf [https://perma.cc/3792-4aa4]. 84. id. at 2. 85. id. 86. tosi et al., supra note 1, at 1642-43; see also wolf et al., supra note 26, at 344 (noting that surgeon unconscious bias may play a role). 87. alan nelson, unequal treatment: report of the institute of medicine on racial and ethnic disparities in health care, 76 annals thoracic surgery s1377, s1379 (2003). 264 indiana health law review [vol. 16:251 situations, but can also cause unconscious bias in well-meaning, well-educated professionals.88 in addition, such unconscious bias can even have self-fulfilling effects by leading to outcomes propagated by the shortcut.89 cognitive shortcutting may be especially prevalent in physicians in high demand, timelimited, and resource-limited environments—like orthopaedic surgeons delivering musculoskeletal care in busy clinics and operating rooms.90 women are less likely to pursue careers in orthopaedic surgery than in any other specialty accounting for only 13% of orthopaedic surgery residents and only 4% of practicing orthopaedic surgeons, even though women make up approximately on half of u.s. medical students.91 the rate of female medical students entering orthopaedic surgery is around 0.6%.92 orthopaedic surgery also has the lowest representation of women academic faculty of any specialty.93 male physicians may unconsciously treat female patients differently than their male counterparts. for example, surgeons in one study were twenty-two times more likely to recommend tkr to standardized male patients with moderate knee oa than female patients with identical disease.94 the researchers concluded that unconscious bias by surgeons played a role in disparate use of tkr between men and women.95 patient-physician communication may play a role in creating disparities. “[t]here are differences in how men and women communicate with physicians, as well as differences in how male and female healthcare providers relate to patients.”96 studies show that having a doctor of the same sex (i.e., gender concordance) improves communication and trust in the doctor patient relationship.97 gender concordance between physician and patient can be important with “evidence suggest[ing] that same-gender dyads strengthen the effects observed.”98 for example, “medical visits between female physicians and 88. id. 89. id. 90. id. 91. rachel rohde et al., where are the women in orthopaedic surgery?, 474 clinical orthopaedics & related res. 1950, 1951 (2016) (explaining that women are only 4% of the fellows of the american academy of orthopedic surgeons, which likely represent almost all practicing orthopedic surgeons); mission and history, per ry in it iat iv e , https://perryinitiative.org/about/mission-statement/ [https://perma.cc/ejt4-w8ah]. 92. rachel rohde et al., supra note 91, at 1954. 93. id. at 1951. 94. wolf et al., supra note 26, at 344; see also kamath et al., supra note 39, at 3358 (“orthopaedic surgeons may be more likely to recommend tka for men than women with moderate oa.”). 95. wolf et al., supra note 26, at 344. 96. id. at 339. 97. debra roter & judith hall, physician gender and patient-centered communication: a critical review of empirical research, 25 ann. rev. pub.health 497, 508 (2004). 98. id. 2019] sex-based disparities in musculoskeletal health care 265 female patients [are] characterized by longer encounter length and more equal patient and physician contributions to the medical dialogue (18, 51)”99 with “more positive statements, head nodding, and interest cues(18, 27).”100 interestingly, “[m]edical visits between male physicians and male patients were characterized by the shortest visit time and the highest level of physician verbal dominance.”101 however, it is not clear that gender concordance would lead to higher satisfaction among female patients, nor improve disparities noted above. interestingly, “on average, female physicians spend 2 minutes longer with patients; however, patient perceptions of female physicians are consistently more likely to be negative compared with male physicians.”102 similarly, in one study of primary care physicians, “female patients who chose female physicians were the least satisfied, while male patients who selected these same female physicians were the most satisfied.”103 “patients who chose a physician of the opposite gender tended to be more satisfied with their physician than patients who selected a physician of the same gender.”104 “‘gender-based’ care ideals such as better communication on social, lifestyle, prevention, and emotional concerns” may lead to higher expectations and lower ratings for female physicians when patients feel these “ideals” are not met.105 interestingly, “[f]emale physicians treating male patients have been shown to display a different manner, including smiling more and acting more interested, than when treating female patients,” which “may account for male patients’ higher satisfaction” with the same female doctors.106 3. lack of education regarding sex-based differences musculoskeletal physicians “do not routinely consider the sex of a patient when evaluating or formulating treatment plans for patients with musculoskeletal disorders.”107 for example, only 37% of physicians had even heard of female athlete triad in a recent study, which has important implications for long term 99. id. 100. id. “a recent comparative study of medical communication in six western european countries also found that female concordant dyads were longer, had higher levels of psychosocial discussion, emotional exchange, and eye contact, and had lower levels of physician verbal dominance.” id. 101. id. 102. wolf et al., supra note 26, at 339. 103. j. schmittdiel et al., effect of physician and patient gender concordance on patient satisfaction and preventive care practices, 15 j. gen. intern med. 761, 768 (2000). 104. id. at 766 (speculating that female patients may have higher expectations of female doctors than male doctors). 105. id. (“[f]emale patients place a higher value than male patients on physicians’ communication skills and personal manner.”). 106. id. at 767. 107. matzkin et al., supra note 52, at 38. 266 indiana health law review [vol. 16:251 bone health in young women.108 failure of doctors to recognize bone issues like female athlete triad in adolescents can lead to lasting effects because failure to accrue important bone mass at an early stage in life may lead to osteoporosis and fragility fractures later in life because 90% of peak bone mass is accumulated by adolescence.109 physicians also generally fail to recognize that women may respond differently to pain and to pain medications than men due to neurophysiologic differences.110 many of the other sex-based differences noted throughout the rest of this article are largely de-emphasized or ignored in medical training—potentially contributing to disparities disfavoring both sexes, but especially women. b. sex-based biologic differences may contribute to some disparities emerging research across organ systems, not just reproductive organ systems, now shows that the human body responds differently based upon sex.111 musculoskeletal medical experts agree that there are “sex-based differences in cell biology, tissue function, and disease presentation and management” affecting musculoskeletal care.112 these differences are related to hormonal and chromosomal (genetic) differences between the sexes.113 “[a] male cell is not the same as a female cell, and sex chromosome-linked genes can be expressed” differently in cells from all organ systems.114 important musculoskeletal differences between males and females include differences in (1) bone size, shape, and material properties, (2) neuromuscular characteristics, (3) ligament properties, and (4) hormonal influences. 108. carter et al., supra note 1, at 449. 109. id. at 448. 110. kamath et al., supra note 39, at 3359 (observing that women have worse pain postoperatively than men); tosi et al., supra note 1, at 1639 (“differences in the efficacy of analgesics in men and women have also been described.”). 111. tosi et al., supra note 1, at 1631 (“[e]merging information . . . provides a compelling case for the existence of innate, and heretofore unexamined, differences between men and women.”); carter et al., supra note 1, at 447 (observing that the “musculoskeletal system is rife with sexual dimorphism” and giving one example as “males have greater bone mass, greater muscle mass, and greater lean mass than do females”); see also, matzkin et al., supra note 52, at 39 (stating (1) “women tend to have less muscle mass and different skeletal muscle fiber composition,” (2) “sex-specific hormones such as estrogen and testosterone are implicated in muscle growth, regulation of muscle mass, and contractile function,” (3) “[w]omen have lower bone mineral density and lower peak bone mass,” (4) “female bone has less cortical area due to reduced periosteal apposition during growth, resulting in intrinsically weaker bone,” and (5) “functional stabilizing control also differs between men and women, because of sex-based differences in muscle recruitment and activation as well as greater ligamentous laxity amongst women”). 112. tosi et al., supra note 1, at 1643. 113. id. at 1643. 114. id. at 1631-32. 2019] sex-based disparities in musculoskeletal health care 267 1. differences in bone size, shape, and material properties first, men and women have different bone characteristics including size, shape, and material properties, and the genes that control bony traits may be different for women than men.115 however, these differences rarely account for disparities in rates of injury or in recovery statistics.116 bone strength is influenced by size, shape, and material properties that differ based upon sex.117 in young adulthood, “men have a bone area that is 35% to 42% larger than women,” which is consistent with men’s generally larger body size.118 at full maturity, generally men’s bones are wider and longer than women’s bones.119 in addition, some differences in the shapes of male versus female bones can lead to disparities. for example, women have anatomic shapes of their shoulder bones that predispose them to shoulder dislocations like smaller glenoids (shoulder socket), higher glenoid inclination angles, and a more oval shape (compared to a more circular shape for men’s glenoids).120 however, a causal link between higher injury rates and smaller bone size or different morphology has not been definitively established. larger bones do not always translate into fewer injuries. for example, young men are more prone to traumatic injuries like fractures generally, where tendencies toward higher risk behaviors and occupations and higher velocity/mass traumas may contribute.121 in addition, women tend to place proportionately less force across their bones and joints due to their generally smaller body size—so that proportionately, their bones are not necessarily smaller in relation to their overall body size. for example, with regard to acl tears in the knee, sex-based smaller boney dimensions and possibly unfavorable acl attachment orientation have not been proven to have a causal relationship to acl injury to date.122 similarly, when falling from a standing height, because men are generally taller, they may fall from a higher height, placing more pressure upon impact and leading to similar fracture risk. 115. id. at 1636 (“bone strength is determined by the morphology (shape and size) and the quality (material properties) of the bones; the genes that control these traits may be different for men and women.”). 116. id. 117. id. 118. wolf et al., supra note 26, at 342. 119. id. 120. carter et al., supra note 1, at 450. 121. see discussion infra note 123. 122. carter et al., supra note 1, at 449 (“sex-based differences in the osseous anatomy of the knee have been reported, including differences in femoral condyle shape, hip version, and the length of the femur compared with the pelvic width [, but t]o date, however, no causal relationship between these factors and acl injury has been proven.”). 268 indiana health law review [vol. 16:251 2. differences in neuromuscular characteristics second, men and women have different neuromuscular characteristics. generally, men have greater lean body mass with muscle composing a larger percentage of body mass than women.123 sex differences in muscle response and recruitment may play a role in some injury patterns.124 men and women have different gait and motion patterns, as well as different responses to muscle stiffness.125 women have an “impaired ability . . . to recover balance after a perturbation” compared to men, potentially leading to more falls.126 however, it is not clear that these differences are causally linked to increased injury rates. for example, sex differences in musculoskeletal stability related to active muscle recruitment and coactivation have been postulated to be related to higher incidences of acl injuries in females, but a causal link has not been proven to date.127 neuromuscular factors are also postulated to be related to higher concussion rates among females. “biomechanical factors such as head size and neck strength and girth have been associated with higher concussion rates among females.”128 biomechanical studies reveal that during trauma “females can experience nearly 50% more head acceleration during head trauma than males” possibly due to more slender necks and weaker neck musculature.129 in addition, as a result of sex-based differences, “[c]oncussion outcome may be worse in females than males.”130 neuromuscular differences may also play a role in how men and women experience pain and pain medications. “[t]he sexes differ qualitatively in their neural processing of pain and analgesia.”131 in other words, “different neural circuits, transmitters, receptors, and genes may be relevant to pain modulation in males and females.”132 generally, “[f]emales are more sensitive to, less tolerant of, and more able to discriminate pain,” and “painful disorders are more prevalent in females than in males.”133 in addition, pain medications may work differently 123. carter et al., supra note 1, at 447 (“[m]ales have greater bone mass, greater muscle mass, and greater lean mass than do females.”); see also matzkin et al., supra note 52, at 39 (explaining “women tend to have less muscle mass and different skeletal muscle fiber composition”). 124. tosi et al., supra note 1, at 1636, 1641 tbl. iii. 125. id. at 1638 (“men and women have different patterns of athletic injuries as well as altered gait and motion patterns. biomechanical responses to muscle stiffness exhibit sex differences.”). 126. id. at 1641 tlb. iii. 127. id. at 1637. 128. andrew lincoln et al., trends in concussion incidence in high school sports: a prospective 11-year study, 39 am. j. sports med. 958, 962 (2011), https://journals.sagepub.com/ doi/abs/10.1177/0363546510392326. 129. carter et al., supra note 1, at 452. 130. lincoln et al., supra note 129, at 962. 131. tosi et al., supra note 1, at 1639 (emphasis omitted). 132. id. 133. id. 2019] sex-based disparities in musculoskeletal health care 269 based upon sex leading do differences in efficacy.134 in addition, neuromuscular differences may lead to disparities in preoperative function prior to joint replacement surgeries.135 3. differences in ligament characteristics sexual dimorphism in ligament laxity is well established and has been partially attributed to hormonal differences.136 generally female ligaments are smaller and more lax than male ligaments on average.137 in some cases, these differences are believed to account for differences in rates of injury. for example, female athletes are more prone to ankle sprains than their male counterparts, possibly due to higher ligamentous laxity, altered proprioception, and/or neuromuscular deficit.138 x-ray tests show that female athletes’ ankles “tilt” under stress around triple the amount males’ ankles tilt using the same test.139 increased shoulder range of motion and greater prevalence of ligamentous laxity also contribute to shoulder instability in females.140 little information is available regarding sex-based treatment differences or in functional outcomes between the sexes with regard to multidirectional shoulder instability.141 however, these differences do not necessarily account for differences in injury rates for all ligaments. for example, while it is true that the acl is generally smaller in females than males and thus likely has a lower load to failure (assuming no sex differences in internal structure of the ligament),142 females likely place a proportionately lower load across their acls given lower bone mass and weights—so it is not surprising that these size differences have not been causally linked to higher incidence of acl tears among females to date. 4. differences in hormonal influences hormonal differences may account for some disparities in male and female 134. id. (“differences in the efficacy of analgesics in men and women have also been described.”). 135. wolf et al., supra note 26, at 344 (noting that “[w]orse preoperative function in women may be related to gender-based differences in neuromuscular activation.”). 136. tosi et al., supra note 1, at 1637-38 (“sex differences in ligament laxity are well established and partially attributed to hormonal differences.”). 137. id. at 1637 (“because the size of the anterior cruciate ligament is generally smaller in females than in males, the loads at failure will be lower, assuming that there are no sex differences in the internal structure of the anterior cruciate ligament.”). 138. wolf et al., supra note 26, at 341. 139. id. (explaining that talar tilt stress radiographs in athletes reveals that female athletes tilted 3.20 in vs. 1.07 in males). 140. carter et al., supra note 1, at 450. 141. id. 142. tosi et al., supra note 1, at 1637. 270 indiana health law review [vol. 16:251 musculoskeletal injury—however, research if far from conclusive. for example, some evidence suggests hormonal differences play a role in acl tears. for acl injuries, researchers know that acl cells (fibroblasts) contain estrogen (and androgen) receptors, but the impact of these receptors is not clear.143 menstrual cycle phase has been found to correlate with the occurrence of acl injury in at least a couple of studies, suggesting circulating hormone levels may play a role.144 research is unclear as to whether estrogen affects ligamentous laxity, and more study is needed.145 in another example, hormonal differences may play a role in concussions where animal studies hint that estrogen has a greater detrimental effect on the brain after trauma in females.146 “concussion outcome may be worse in females than males” with differences noted in baseline neuropsychological function and in post concussion outcomes for collegiate athletes.147 also, hormonal differences may account for differences in rates of arthritis in the knee in females versus males. between the ages of fifty and seventy-nine, women lose articular cartilage in their knee three to four times faster than men.148 the reasons behind these differences is unclear.149 estrogen may play a role because knee articular cartilage contains estrogen receptors and oa is higher incidence in postmenopausal women.150 estrogen replacement therapy did prevent around 13% of tkrs in one study—but the finding was not statistically significant and other studies have been contradictory.151 biologic processes (like inflammation) and physical factors (like obesity and physical activity) can influence the prevalence of oa of the knee.152 obesity has a stronger association with onset and progression of knee oa in women than men—possibly due to an increase in inflammatory cytokines and mechanical factors.153 this is another area 143. wolf et al., supra note 26, at 340. 144. tosi et al., supra note 1, at 1638 (noting a study finding a correlation between “the occurrence of a noncontact injury of the anterior cruciate ligament and the female collegiate athlete’s menstrual cycle” and another study demonstrating “an effect of menstrual cycle phase on anterior cruciate ligament injury”). 145. id. (noting one study “observed a negative effect of high-dose estrogen on rabbit ligament laxity,” while another study “reported no difference,” and that “the basis for the sex differences in ligament laxity remains controversial”). 146. carter et al., supra note 1, at 452. 147. lincoln et al., supra note 129, at 962. 148. wolf et al., supra note 26, at 342-43 (observing that mri studies show that women lose articular cartilage in the knee (tibia) at four times the annual rate of men between the ages of 50 and 79 and that women lose their kneecap cartilage at a rate of 3.3% annually compared to 1.4% for men). 149. id. at 343. 150. id. 151. id. (explaining that while hormone replacement therapy decreases joint pain, it does not protect against development of oa on x-ray at 14 years). 152. id. 153. id. 2019] sex-based disparities in musculoskeletal health care 271 where research to understand gender-based biologic differences may be helpful.154 c. cultural or societal differences in sex-based expectations leading to disparities cultural or societal differences in sex-based expectations and socioeconomic status can play a role in disparities. men and women tend to behave in different ways culturally in society (e.g., they dress differently, enjoy different activities, eat differently, etc.). these differences in behavior may be related to societal or cultural pressures, but may also reflect biologic differences related to genetic and hormonal influences. for example, identical twin studies demonstrate the strong influence that genetics have on behavior.155 cultural and/or social pressures/differences include: (1) societal influences, (2) relationship factors including intimate partner violence (ipv), (3) risk preferences, and (4) socioeconomic factors. 1. societal influences societal influences may include differences in (a) dietary pressures, (b) functional expectations, (c) willingness to reveal injury, (d) exercise patterns and responses, and (e) stereotyping of particular female-dominated activities. a. dietary differences leading to stress fractures dietary differences between the sexes begin in childhood and adolescence. girls “[feel] obliged” to “be slim” and therefore “eat less and pay attention to calories, sugar and fat intake.”156 consequently, “girls are more likely than boys to develop eating disorders (i.e., anorexia, bulimia, binge eating disorder).”157 dietary disorders among young active women can lead to hormonal irregularities and stress fractures. the task force on women’s issues of the american college of sports medicine identified the syndrome they called female athlete triad describing 154. id. 155. thomas bouchard et al., sources of human psychological differences: the minnesota study of twins reared apart, 250 science 223, 223 (1990) (noting that on “multiple measures of personality and temperament, occupational and leisure time interests, and social attitudes” that identical twins reared apart are “about as similar” as identical twins reared together—suggesting that genetics, and not environment, may play a larger role in behavior). 156. claudia arganini at al., gender differences in food choice and dietary intake in modern western societies, in public health: social and behavioral health 83, 89 (2012), http://cdn.intechopen.com/pdfs/36935/intech-gender_differences_in_food_choice_and_dietary_ intake_in_modern_western_societies.pdf [https://perma.cc/5dje-nj9l]. 157. id. (explaining that women—especially during childhood and adolescence—are more likely to have eating disorders than men). 272 indiana health law review [vol. 16:251 disordered eating or low energy availability, menstrual irregularities (i.e., amenorrhea), and low bone mineral density (bmd).158 up to 36% of female high school athletes have demonstrated low energy availability possibly reflecting an eating disorder.159 similarly, 54% of female high school athletes had menstrual dysfunction.160 in one study, 11% of adolescent female athletes had bone stress injuries related to female athlete triad.161 because 90% of peak bone mass is accumulated by adolescence, failure to accrue important bone mass at an early stage in life may lead to osteoporosis and fragility fractures later in life—so, the effects of early dietary discrepancies between females and males may persist into later life.162 supporting the idea that societal pressure may play a significant role in development of female athlete triad and its associated bone stress injuries and fractures, a similar syndrome called “red-s” is relatively common in male athletes who “participate in sports emphasizing leanness, including aesthetic sports (e.g., [sic] gymnastics), endurance sports (e.g., [sic] running, cycling), and sports with weight classification (e.g., [sic] rowing, wrestling).”163 b. functional expectations: patient preferences or doctor biases? some researchers suggest that women may be more willing to accept functional limitations than men. physicians and/or their female patients may view “symptoms and functional loss as less important for women than for men,” and therefore women may choose or be steered toward less aggressive courses of treatment than men.164 in addition, “[m]en may place greater value on physical function than women and therefore accept greater potential risk to improve their functional status.”165 women tend to be operated on at a more advanced stage of the disease, suggesting either patient delay or doctor delay in scheduling surgery.166 for example, women tend to present to orthopedic surgeons for treatment of their knee oa later in the course of the disease than men.167 but delay in elective surgery is not necessarily discriminatory or negative. researchers could not tell whether women received surgery “too late in the 158. carter et al., supra note 1, at 448. 159. id. (including 63% of endurance athletes and 77% of ballet dancers). 160. id. (including 60% of endurance athletes and 36% of ballet dancers). 161. id. 162. id. 163. id. at 449. 164. katz et al., supra note 39, at 693. 165. id. 166. id. at 692 (explaining that “women undergoing 3 major orthopedic procedures have worse preoperative functional status than men, suggesting that they are operated on at a more advanced stage in the course of disease”). 167. singh et al., supra note 41, at 1100; katz et al., supra note 39, at 692 (observing that differences in preoperative functional status were “not explained . . . by variables . . . [like] age, comorbidity, body mass index, work status, and whether patients live alone).” 2019] sex-based disparities in musculoskeletal health care 273 course of disease, men too early, or whether the patterns we observed were appropriate.”168 they observed that if “men and women receive services consistent with their preferences [under informed consent doctrine], the disparities . . . observed may be appropriate.”169 however, even appropriate delays respecting patient preferences can lead to disparities after surgery. researchers speculate that worse outcomes may be due to the fact that women undergo tkr when the arthritis is in a more advanced state, which correlates with worse functional outcomes after surgery.170 c. willingness to reveal injury: male underreporting may lead to sampling error inflating apparent disparities males may perpetuate sampling errors by being less likely to reveal injury, which can lead to erroneous appearance of a disparity. “evidence suggests that females are more willing than males to report general injuries, which represents a potential bias toward increased detection in females.”171 in addition, women report more disabilities than men when dealing with “similar observed difficulty in performing specific tasks.”172 “male athletes may be more likely than female athletes to hide concussions and fail to report them for fear of not being able to continue playing or to participate in sports.”173 “gender stereotypes may reinforce this behavior, with boys wanting to appear ‘manly’ after sustaining a concussion and ‘toughing it out’.”174 some researchers find that adult men likewise may be underreporting functional impairments.175 d. exercise and landing position factors in acl tears [elissa stop] in jumping sports, girls tend to land differently than boys, leading to higher incidence of acl injuries. before puberty, males and females land similarly with knees wide apart, but this changes after puberty such that females land with their knees closer together in a position called “valgus,” which makes females more prone to acl tears because it increases strain across the acl.176 whether this is 168. katz et al., supra note 39, at 692. 169. id. at 694688. 170. kamath et al., supra note 39, at 3359 (observing that women have worse functional outcomes after tka with regard to postop rom). 171. lincoln et al., supra note 129, at 962; see also katz et al., supra note 39, at 692 ( “[w]“omen have been noted to report more disability than men with similar observed difficulty in performing specific tasks[, so,] our findings may simply indicate that men underreport, or women over-report, functional limitations.”). 172. katz et al., supra note 39, at 692. 173. carter et al., supra note 1, at 452. 174. id. 175. katz et al., supra note 39, at 692. 176. tosi, et al., supra note 1, at 1637. 274 indiana health law review [vol. 16:251 a learned social response or a biologic response to differences in body characteristics is difficult to say. likewise, modifiable leg and pelvis positioning tendencies demonstrated while performing mini-squats make female athletes more vulnerable to acl rupture.177 e. sex-stereotyping: failure to adequately recognize health risks associated with some predominantly female athletic activities failure of medical professionals and educational institutions to recognize some traditionally female activities as “sports” with injury potential can lead to disparities that compromise musculoskeletal safety. for example, 96.8% of injured high school cheerleaders are girls.178 “cheerleading athletes have historically been marginalized as supportive performers.”179 in addition, medical professionals often fail to recognize the risks and schools fail to recognize the medical needs of some female athletes—like cheerleaders.180 cheerleading is not just a sideline activity, it is an athletic and competitive sport at many schools.181 “approximately 400,000 students participate in u.s. high school cheerleading annually,” which ranks cheerleading as the “fourth most popular high school girls’ activity.”182 although cheerleading is relatively safe overall, when injuries do occur, they may be more severe, with catastrophic injury rates in cheerleading accounting for 65% of female catastrophic injuries in high school sports.183 2. relationship factors: intimate partner violence (ipv) is more likely to be a cause of fracture in women musculoskeletal injuries are one of the most common manifestations of intimate partner violence (ipv), which is the “leading cause of non-fatal injury to women worldwide.”184 “one in six women [orthopedic fracture clinic patients] . . . disclosed a history of ipv within the previous year, and one in three had . . . experienced ipv in their lifetime.”185 almost 2.2% (1/50) of women in the orthopedic fracture clinic attended their visit as a direct result of ipv, but only 177. carter, supra note 1, at 449 (table 1). 178. dustin w. currie et al., cheerleading injuries in united states high schools, 137 pediatrics 1, 1 (2016), http://pediatrics.aappublications.org/content/pediatrics/137/1/e20152447. full.pdf [https://perma.cc/uj9t-q8a2]. 179. id. at 7. 180. cheerleading: where the injuries are less frequent, more severe, health essentials: brain & spine (jan. 13, 2017), https://health.clevelandclinic.org/cheerleading-injuries-lessfrequent-severe/ [http://perma.cc/yel4-q5m8]. 181. id. 182. currie, supra note 179, at 2. 183. id. at 7. 184. praise investigators, supra note 36, at 866. 185. id. 2019] sex-based disparities in musculoskeletal health care 275 14% of them were ever asked about ipv in a health care setting.186 3. preferences and risks men and women tend to view risk differently.187 these differences can lead to an increased prevalence of risk-related injuries in men, such as fractures and dislocations associated with trauma from risky behavior. in addition, men may be more willing to accept surgical risks in order to gain improved function than women, leading to differences in rates of choosing elective surgeries like joint replacements. a. risk taking behaviors: risk of injury men tend to engage in activities with higher risks of musculoskeletal injury at higher rates than women.188 men are more likely to poorly manage anger and stress than women.189 “men abuse alcohol and other drugs at least twice as often as women.”190 men “commit 86% of violent crimes.”191 although women fracture patients are at risk of being victims of violence at the hands of men, men actually injure and “kill other men at a significantly higher rate than they do women.”192 “men are three times as likely as women to be involved in fatal car accidents.”193 in the u.s., men “constitute more than ninety percent of those employed in dangerous occupations, and men have a much higher workplace injury rate than do women.”194 “men are also injured in and killed in wars at far greater rates than women.”195 all of the above contribute to differing types and rates of musculoskeletal injury among men and women. b. risk taking behaviors: accepting surgical risks similarly, men may be more willing to engage in activities with inherent risks—like surgery. women may be more inclined than men to avoid taking risks associated with surgery due to different analysis of the risk/benefit ratio of the 186. id. at 872. 187. christine r. harris et al., gender differences in risk assessment: why do women take fewer risks than men? 1 judgment and decision making 48, 48 (july 2006), http://journal.sjdm.org/jdm06016.pdf [https://perma.cc/2bxy-4uqu]. 188. dworkin, supra note 68, at 464. 189. id. 190. id. 191. id. 192. id. at 465. 193. harris, supra note 188, at 48; see also, dworkin, supra note 68, at 464 (noting that men are involved in car accidents at higher rates than women). 194. dworkin, supra note 68, at 465. 195. id. 276 indiana health law review [vol. 16:251 surgical procedure.196 likewise, “men may place greater value on physical function than women and therefore accept greater potential risk to improve their functional status.”197 return to physical activities may be more important psychologically for men, which may account for differences in statistics regarding return to activities.198 “[i]f . . . men and women receive services consistent with their preferences, the disparities . . . may be appropriate.”199 researchers indicate that these are only theoretical differences and that further study is required.200 4. socioeconomic status and practical considerations socioeconomic status can play a major role in propagating disparities. poverty, lack of insurance, lack of transportation, and similar issues can create barriers to access necessary musculoskeletal care. likewise, practical barriers like living alone, lack of a social support network to help during times of recovery from injury/illness, and caregiver obligations for dependent family members or friends can limit access to musculoskeletal care. a. poverty, lack of insurance (or under insurance), transportation, etc. “[p]overty has always been a key factor in determining a person’s prospects for health.”201 women are more likely to be living in poverty than men.202 also, socioeconomic pressures may play a role in accepting lower functional levels where women may be less likely to be able to afford expensive procedures. factors contributing to women’s lack of access to health care include “lack of transportation, inability to pay for services, [and] lack of health insurance.”203 women are often the primary caregivers to the children in their family, and therefore, “women are less likely to have employment-related health insurance coverage” than men.204 “thus, in general, women are less likely to have private insurance and are more likely to have public assistance coverage.”205 in addition, many private insurance policies and medicaid “do not cover many important services for women.”206 therefore, elective surgeries like knee replacement may be relatively inaccessible to women compared to men. 196. katz, supra note 39, at 693 (stating “women may be more averse to taking risks than are men, and avoid surgery because of its potential complications”). 197. id. 198. id. at 692. 199. id. at 694. 200. id. 201. susan l. waysdorf, fighting for their lives: women, poverty, and the historical role of united states law in shaping access to women’s health care, 84 ky. l. j. 745, 745 (1996). 202. id. at 760. 203. id. at 756. 204. id. at 757. 205. id. 206. id. 2019] sex-based disparities in musculoskeletal health care 277 b. practical barriers: living alone, lack of social support network, caregiver obligations “practical considerations may prompt women to defer surgery as long as possible”; for example, “women more often live alone or take care of disabled spouses.”207 women undergoing total knee replacement are four times more likely to live alone than men.208 in addition, women are more likely to be functioning as caregiver and may be less able to take time to care for themselves.209 lesser social support networks can play a role in delaying elective surgeries;210 this may be particularly relevant for african american women because “[o]nly 30.8% of african-american women had someone at home to care for them after surgery compared to 50% of african-american men and 75% of caucasians.”211 these practical issues present barriers to major surgeries like joint replacement surgery. women living alone have been shown to more commonly delay surgery and have worse 1-year outcomes.212 social or familial support is usually necessary for the patient after major surgeries like joint replacement after they return home in the weeks immediately following the surgery.213 therefore, due to delays in seeking care, women may experience decreased function, be older in age, and have more pain compared to men immediately prior to their elective surgeries.214 however, disparities are present, even when living arrangements are considered, so the other disparities mentioned above also likely play a more significant role in the overall causation of disparities. 207. katz, supra note 39, at 693; see also rajiv gandhi et al., effect of sex and living living arrangement on the timing and outcome of joint replacement joint replacement surgery, 53 can. j. surgery 37, 37 (2010) (“patients who live alone may delay joint replacement surgery until an older age and have greater joint pain and dysfunction than those who live with another person, leading to poorer 1-year outcomes.”). 208. katz, supra note 39, at 691 (table 1) (finding 33.6% of women undergoing total knee replacement lived alone versus 8.3% of men). 209. women and caregiving: facts and figures, fam. caregiver all. (dec. 31, 2003), https://www.caregiver.org/women-and-caregiving-facts-and-figures [https://perma.cc/w4vz9w64] (noting that “[a]n estimated 66% of caregivers are female”). 210. id. at 694 (noting additional social support services might help women acting as caregivers decide to have elective surgeries sooner). 211. kamath, supra note 39, at 3359. 212. wolf, supra note 2726, at 344; see also, gandhi, supra note 209208, at 37 (“patients who live alone may delay joint replacement surgery until an older age and have greater joint pain and dysfunction than those who live with another person, leading to poorer 1-year outcomes.”). 213. katz, supra note 39, at 694 (noting additional social support services might help women acting as caregivers decide to have elective surgeries sooner). 214. wolf, supra note 2726, at 344. 278 indiana health law review [vol. 16:251 iii. law and policy solutions to sex-based disparities in musculoskeletal health sex-based disparities in musculoskeletal care are multifactorial and complex, and correction of disparities will require combined efforts by lawmakers, policymakers and medical professionals. solutions to gender disparities in musculoskeletal care include: (a) improving sex-based musculoskeletal care in the medical community, (b) embracing sex-based differences in health care needs in musculoskeletal care, and (c) addressing societal and cultural factors. a. improving sex-based musculoskeletal care in the medical community in the medical community, improving musculoskeletal care in both sexes can be achieved by (1) sex-specific medical research and (2) increasing the sex diversity of musculoskeletal professionals. in addition, incorporation of sex-based differences in musculoskeletal medicine in medical education is important and is covered in the next section (b). 1. sex-specific medical research increased understanding of sex-based differences related to genetics, hormones, and biologic makeup gained through sex-specific scientific research should improve health outcomes for both sexes. in the past, “[o]nly rarely have sex-specific differences been considered when defining how best to provide clinical care.”215 nih is already attempting to address this issue in government funded research. nih-funded clinical research has been undergoing changes to include more women in research. concerns were raised in the late 1980s that clinical research being conducted primarily using males was being applied to women.216 in 1990, the office of research on women’s health was established to ensure inclusion of women in nih-funded clinical studies.217 the nih revitalization act of 1993218 included four major requirements on the inclusion of women in clinical research: (1) “ensure that women . . . are included in all human-subjects research;” (2) “ensure that in phase 3 clinical trials [if evidence reveals likelihood of sex-based differences], women . . . are included in such a way that valid analyses of differences in intervention effect can be performed;” (3) “not allow cost to be used as an excuse for excluding [women];” and (4) “initiate programs and support for outreach efforts to recruit [women] groups into clinical studies.”219 these changes have produced some positive effects. by 2000, the gao 215. tosi, et al., supra note 1, at 1632. 216. wiseman, supra note 83, at 4 (box 1). 217. id. 218. national institute of health revitalization act of 1993, pub. l. no. 103-43, 107 stat. 122. 219. wiseman, supra note 83, at 4 (box 1). 2019] sex-based disparities in musculoskeletal health care 279 “reported that nih had made substantial progress in strengthening and implementing its policy on inclusion of women in clinical trials.”220 other researchers noted, nih has “implemented a series of policy changes that substantially increased the proportion of females participating in nih-funded clinical trials,” which is already “improving our understanding of sex-based differences that exist in clinical medicine.”221 in addition, the researchers acknowledged that the nih is focusing on “ensuring that preclinical trials include both male and female cells and animals in the laboratory.”222 however, even today, “[p]otential sex bias [still] exists in orthopaedic surgery basic science and translational research, with an overrepresentation of male specimens.”223 basic science research forms the foundation for subsequent clinical research, which can propagate disparities if sex-based differences go unrecognized.224 in a systematic review in 2018, 35% of authors “did not report the sex of animals, cells, or cadavers used.”225 in the studies where sex was reported, 43% used male only, 25% used female only, and 33% used both sexes.226 when both sexes were used, only 13% of authors reported sex-based results. 227 additional studies, similar to the 20-plus year, multi-billion-dollar women’s health initiative (whi) sponsored by the national institutes of health (nih) should be supported—with attention to differences in musculoskeletal health. the whi is a “long-term national health study that has focused on strategies for preventing major causes of death, disability, and frailty in older women, specifically heart disease, cancer, and osteoporotic fractures.”228 the study originally enrolled over 161,000 women aged 50-70 between 1993 and 1998, and it included a clinical trial part including over 68,000 women and an observational study part including over 93,000 women.229 the study has been extended several times, most recently in 2015 for an additional five years of funding to continue follow-up of participants through 2020 with annual reports available online.230 220. id. 221. carter, supra note 1, at 447. 222. id. 223. jessica bryant, et al., potential sex bias exists in orthopaedic basic science and translational research, 100 j. bone joint surg. 124, 124 (jan. 17, 2018). 224. id. 225. id. 226. id. 227. id. 228. about whi, women’s health initiative, https://www.whi.org/about/sitepages/ about%20whi.aspx [https://perma.cc/83sw-c3f4]. 229. id. 230. whi extension study 2005-2010, https://www.whi.org/about/sitepages/whi% 20extension%202005-2010.aspxwomen’s health initiative, https://www.whi.org/about/ sitepages/whi%20extension%202005-2010.aspx [https://perma.cc/4a2f-w5x6]. 280 indiana health law review [vol. 16:251 over the years, the whi ground-breaking study has yielded important sexspecific treatment recommendations for women with regard to major diseases affecting postmenopausal women.231 results from the whi hormone trials alone “have been estimated to have already saved $35.2 billion in direct medical costs in the u.s. alone.”232 in addition, over 1,400 articles have been published by the whi, and 289 ancillary studies have been funded.233 these articles and studies have impacted management of women’s coronary heart disease, stroke, breast cancer, colorectal cancer, endometrial cancer, ovarian cancer, osteoporotic fractures, diabetes, and total mortality.234 more also needs to be done in nongovernmental research. “nih does not have any control over what is published in the scientific literature.”235 medical journal editors and editorial bodies—such as the international committee of medical journal editors (icmje)—are “uniquely positioned as gatekeepers for much of the scientific knowledge that reaches the public domain”—including appropriate consideration of sex differences and noting that “one size does not fit all.”236 guidelines could be set for manuscripts to be included in musculoskeletal publications such that the sex of origin of tissues, cells, animals, and humans in the studies must be considered in analysis with reporting of any sex differences.237 in addition, pregnant women should be included in orthopedic research.238 because of exclusion, 80% of pregnant women are prescribed treatments that have never been studied in pregnant women.239 pregnant women are capable of autonomous decision-making for themselves and for their fetuses, just as they will be for their children when they become mothers.240 therefore, they should be allowed to participate in clinical trials involving musculoskeletal care where appropriate.241 some additional protections for physicians regarding potential malpractice risks may be necessary to encourage physicians to offer pregnant women these opportunities.242 “in the orthopaedic practice of the future, sex differences in the physiology 231. id. 232. id. welcome to women's health initiative, women’s health initiative, https://whi.org/sitepages/whi%20home.aspx?tabyitgl/viom/sg-cialisbyitgl/v-price/4/ [https://perma.cc/5zvz-tp8j]. 233. id. 234. observational study (os), women’s health initiative, https://www.whi.org/ about/sitepages/observational%20study.aspx [https://perma.cc/6w5g-mprf]. 235. wiseman, supra note 83, at 40. 236. id. 237. id. 238. katrina heyrana et al., increasing the participation of pregnant women in clinical trials, 320 jama 2077 (2018), https://jamanetwork.com/journals/jama/fullarticle/2714380 [https://perma.cc/76pt-rvbw]. 239. id. 240. id. 241. id. 242. id. 2019] sex-based disparities in musculoskeletal health care 281 and pathogenesis of disease will determine how each patient is treated.”243 priorities include (1) monitoring musculoskeletal diseases for sex differences related to diagnosis and treatment, (2) analyzing age studies by sex, (3) improving availability of sex-specific data, (4) stratifying of studies based on sex, (5) expanding research involving neurologic responses to pain and analgesia between sexes, and (6) promoting of sex-specific research on the molecular, cellular, and tissue levels.244 much research is needed to improve treatment of musculoskeletal diseases with proper recognition of sexual dimorphism. 2. diversification of the medical professional community musculoskeletal doctors are predominantly male. in 2014, only 6.1% of fully accredited practicing orthopaedic surgeons were women.245 women are less likely to pursue careers in orthopaedic surgery than any other specialty with the rate of female medical students entering orthopaedic surgery being around 0.6%.246 if more women were in the field of orthopaedic surgery, it is possible that some disparities in musculoskeletal care might improve by decreasing male bias in the profession, possibly increasing attention to female issues previously unrecognized, and by improving gender concordance between doctors and female patients. as explained above, gender concordance between doctor and patient may help improve care in some instances. increasing the number of female orthopaedic surgeons could be approached in several ways. first, getting more women to consider orthopaedics as a career might be accomplished by requiring early exposure to musculoskeletal care during medical school.247 early exposure to orthopaedics by requiring musculoskeletal education in medical school leads to higher rates of application to orthopaedic residencies—especially among women who had a 75% higher rate of orthopaedic residency applications when musculoskeletal education was required by their medical school.248 second, the “most common reasons indicated for why women might not choose orthopaedics included perceived inability to have a good work/life balance (78%), perception that too much physical strength is required (74%), and lack of strong mentorship in medical school or earlier (69%).”249 adherence to work-hour regulations helps make “[t]he prolonged hours of surgical training appear less daunting” and may “account for the increased pursuit of surgical residencies by 243. tosi et al., supra note 1, at 1643. 244. id. at 1631. 245. mission and history, the perry initiative, https://perryinitiative.org/about/missionstatement/ [perma.cc/ejt4-w8ah]. 246. rohde et al., supra note 91, at 1954. 247. id. at 1955. 248. id. 249. id. at 1950. 282 indiana health law review [vol. 16:251 women.”250 although physical strength can seemingly be required for some orthopaedic tasks, like reducing a hip dislocation, women and older men with less strength obviously practice orthopaedic surgery successfully, so physical concerns could be addressed by mentoring of medical students by female orthopaedic surgeons.251 “role models have been shown to attract medical students to surgical subspecialty training, and an interested mentor has been cited as the most important factor in a medical student initially being attracted to a field.”252 orthopaedic surgery has the lowest representation of women academic faculty of any specialty, and female representation on medical faculties “has been associated with whether women medical students choose surgery as a career.”253 without a “critical mass” of female orthopaedic faculty members, female medical students may be dissuaded from applying for orthopaedic residency positions.254 “programs designed to improve mentorship . . . will be important to attract” more women to orthopaedics.255 increasing diversity of orthopaedic faculty through “targeted programming and recruitment” may also be an option.256 one example of a targeted approach is the perry initiative, a 501(c)(3) nonprofit organization named after dr. jacquelin perry, one of the first ten women orthopaedic surgeons in the u.s.257 the perry initiative is “committed to inspiring young women to be leaders in . . . orthopaedic surgery” by running outreach programs in high schools, colleges, and medical schools.258 founded in 2009, the perry initiative now “runs over 40 one-day outreach programs nationwide and has reached over 7500 high school, college, and medical students through over 260 outreach events.”259 these day long events allow participants to perform mock orthopaedic surgeries, while also hearing from prominent women orthopaedic surgeons.260 “perry initiative medical student outreach programs are hosted by medical schools and connect students to orthopaedic surgeon mentors and like-minded peers, as well as introduce fracture fixation techniques and power tools.”261 250. id. at 1955. 251. id. (noting that “mentorship—when present—plays a role in career choice and advancement”). 252. id. 253. id. 254. id. (observing that “absence of a ‘critical mass’ of women may dissuade female applicants.”). 255. id. at 1951. 256. id. at 1955. 257. the perry initiative, supra note 246. 258. id. 259. id. 260. program description, the perry initiative, https://perryinitiative.org/programs/ outreach-program/ [https://perma.cc/f3fp-qckk]. 261. id. 2019] sex-based disparities in musculoskeletal health care 283 b. embracing, acknowledging, and treating sex-based care needs in musculoskeletal education and care recognition of sex-based differences in experience, diagnosis, and treatment of musculoskeletal disease is an important step in eliminating disparities in musculoskeletal care because development of sex-based treatment algorithms is needed to help eliminate disparities and improve care of both sexes. to optimize women’s (and men’s) musculoskeletal care, sex-based differences should be recognized and treated, and laws and policies should allow physicians to safely embrace and acknowledge these biologic, cultural, and societal differences in order to eliminate disparities and prevent discrimination against either sex. 1. in medicine musculoskeletal health care professionals, like orthopaedic surgeons, often fail to consider the patient’s sex in treatment decisions.262 health care professionals need to be “[sex] sensitive” to optimally treat both sexes by showing “sensitivity to [sex] issues in clinical decision-making” and by having “an awareness that [sex] . . . affects the presentation of health complaints.”263 failure to recognize and acknowledge these differences based upon biologic sex leads to disparities and discrimination in musculoskeletal care.264 “targeted attempts to provide early and ongoing education regarding sex-based differences in musculoskeletal disorders are likely necessary to address this knowledge gap.”265 a few currently known examples follow. with continued research, other differences are likely to continue to be delineated. a. sports medicine first, active young women and girls need musculoskeletal care providers to recognize and treat sex-based differences.266 “mounting evidence exists supporting the concept that the incidence, clinical presentation, and functional 262. matzkin, supra note 52, at 38 (“orthopaedic surgeons [and other musculoskeletal professionals] do not routinely consider the sex of a patient when evaluating and formulating treatment plans for patients with musculoskeletal disorders.”). 263. celik, supra note 3, at 2 (“[sex] differences contribute to patients’ health and illness,” and “[r]ecognizing these differences and taking them into account can improve the quality of care.”). 264. carter, supra note 1, at 447 (“by improving our understanding of these sex-based differences, orthopaedic surgeons may be better equipped to care for patients with common sports injuries and improve treatment outcomes.”). 265. matzkin, supra note 52, at 38. 266. carter, supra note 1, at 448 (“investigating this and similar hypotheses in a systematic fashion may lead to the development of sex specific treatment algorithms that may optimize clinical outcomes.”). 284 indiana health law review [vol. 16:251 outcomes for male and female patients with sports injuries may profoundly differ.”267 for starters, medical professionals working with colleges, universities, and high schools should promote development of female specific athletic training protocols because physical exercise exhibits sexual dimorphism.268 for example, the prevalence of female acl tears might be reduced with sex-specific athletic training. experts generally agree that “modifiable factors may be more important in explaining the higher incidence of noncontact acl injuries among female athletes.”269 sex-specific training regarding landing patterns in jumping sports and positioning techniques during exercise might reduce the prevalence of acl tears among female athletes.270 policymakers should support research and development of female specific exercise protocols to bring female acl injuries more in line with male numbers, and coaches and trainers should be encouraged and educated to understand and recognize differences between male and female athletes. in addition, “males and females differ in their response to exercise with regard to fuel utilization patterns, temperature control, neuroendocrine regulation, immune response, and muscle damage.”271 “males demonstrate a substantial increase in muscle heat shock protein” compared to females following exercise, which enhances protection of heart muscle and inhibits muscle damage in males—with “important implications to the efficacy of exercise . . . across the life span of both men and women.”272 attention to these sex-specific differences by medical professionals and policymakers involved in sports medicine is important. similarly, sex-specific concussion prevention and treatment should be considered more frequently. in similar sports (baseball/softball, basketball, and soccer), females had “roughly twice the concussion risk of males.”273 to remedy this, modifications should be considered to rules, protective equipment, and/or level of contact permitted to bring females’ concussion risk more in line with males.274 this idea is supported by the fact that girls participating in lacrosse had a lower concussion rate than boys participating in lacrosse—where there are fundamental differences in the rules, protective equipment, and level of contact based upon sex.275 in male lacrosse, checking or physical contact with body or 267. id. at 447. 268. matzkin, supra note 52, at 39. 269. carter, supra note 1, at 449. 270. id. (noting that a significant modifiable risk factor for acl injury is the way athletes land after jumping with female athletes tending to land in a way that predictably leads to acl injury and that modifiable leg and pelvis positioning tendencies make female athletes more vulnerable to acl rupture); see also, tosi, supra note 1, at 1638 (noting that before puberty, males and females land similarly with knees wide apart, but this changes after puberty such that females land with their knees closer together in a position called ‘valgus,’ which makes females more prone to acl tears because it increases strain across the acl.). 271. tosi, supra note 1, at 1638. 272. id. 273. lincoln, supra note 129, at 961. 274. id. at 962. 275. id. at 960. 2019] sex-based disparities in musculoskeletal health care 285 sticks is allowed, whereas in female lacrosse, there is a no-checking rule.276 women’s sticks are smaller than men’s, meaning contact with the smaller stick may be less likely to cause injury.277 also, “[m]ost female players are required to wear goggles and mouth guards.”278 in addition, expanded access to athletic trainer coverage for female athletes should be considered because it increases the likelihood that concussions are recognized and treated.279 further, new state laws, along with rule changes and treatment recommendations by national organizations, can lead to improvement in concussion recognition and treatment.280 also, surprisingly only 37% of physicians in one study had heard of female athlete triad mentioned above, which can have significant effects on bone mass in teenage girls—so better physician education is needed.281 failure to develop strong bone mass at an early stage in life can be particularly important because 90% of peak bone mass is accumulated by adolescence, which means that untreated girls may end up with a higher incidence of osteoporosis and fragility fractures later in life.282 early treatment and recognition can therefore have dramatic and permanent positive effects. finally, some traditionally female-dominated sports—like cheerleading—should be recognized as sports potentially warranting closer attention to potential injuries. designation of cheerleading as a “sport” is important, so that it is subject to rules and regulations set forth by organizations like the ncaa—improving access to “athletic trainers, appropriate medical care, certified/qualified coaches, better facilities, and an injury surveillance program.”283 designation as a “sport” also ensures that cheerleaders must get a pre-participation physical examination and have access to appropriate strength 276. what’s the difference between men’s and women’s lacrosse, dick’s pro tips, https://protips.dickssportinggoods.com/sports-and-activities/lacrosse/whats-the-difference-betweenmens-womens-lacrosse (last visited nov. 30, 2018) [https://perma.cc/hgs3-6gzt]. 277. id. 278. id. 279. lincoln, supra note 129, at 962 (noting that expanded access to athletic trainers from two part time to one full time and one part time trainer led to better concussion recognition and treatment). 280. lincoln, supra note 129, at 962 (“new state laws and rule changes and treatment recommendations by the national collegiate athletic association, the national athletic trainers’ association, the national federation of state high school associations, the centers for disease control and prevention, and sports-governing bodies have likely contributed to greater awareness of concussion among players, coaches, parents, and clinicians.”). 281. carter, supra note 1, at 449. 282. id. at 448. 283. grant jones & michael khazzam, cheerleading injuries, sports medicine (am. orthopaedic soc. sports med., rosemont, ill.), 2017, at 3, 6. https://www.sportsmed.org/ aossmimis/members/downloads/smu/2017fall.pdf [https://perma.cc/u8e6-x4u6]. 286 indiana health law review [vol. 16:251 and conditioning programs.284 this is important because cheerleading leads to a disproportionately high rate of catastrophic injuries, accounting for over 65% of catastrophic injuries in female high school athletes—“including skull fractures, death, cervical fractures or major ligamentous injury, spinal cord contusions, paralysis, and severe head injuries resulting in permanent brain injury.”285 prevention efforts should “focus on activities placing cheerleaders at risk for severe injuries,” including practices—where cheerleaders are particularly susceptible to injury.286 safety organizations like the american association of cheerleading coaches and administrators (aacca), the united states all star federation (usasf), cheersafe, and the national federation of state high school associations (nfhs), and even the american academy of pediatrics (aap) are important in helping reduce these numbers.287 emergency plans should be developed for serious injuries to involve athletic trainers and team physicians.288 cheer venues should be compliant with national safety recommendations, including appropriate medical coverage and proper landing mat, foam floor, or grass/turf.289 adequate supervision by properly trained coaches is important to prevent and treat injury.290 b. general musculoskeletal care musculoskeletal evaluation, intraoperative decision making, and postoperative care often need to be modified based upon sex. a few known examples follow here. many more are evident, and more are likely to be discovered with increased attention to this issue. first, attention to sex-specific musculoskeletal disease patterns is necessary. one example is obviously fracture care with the recognition and treatment of intimate partner violence (ipv) among women with broken bones. almost 2% of women in the orthopedic fracture clinic attended their visit as a direct result of ipv, but only 14% of them were ever asked about ipv in a health care setting.291 musculoskeletal professionals should be trained to recognize that ipv is a “serious public health issue that affects a large proportion of orthopaedic 284. id. at 4, 6 (by 2012, “only 29 state high school athletic associations recognized cheerleading as a sport and the [ncaa] did not include competitive cheerleading as a sponsored sport.” therefore, up until more recently, “injuries that occur[ed] in cheerleading [were] often not reported in sports injury surveillance systems.”). 285. id. at 4, 5 (observing that cheerleading accounted for 71% of catastrophic injuries to female college athletes in one study over a 17-year period). 286. currie, supra note 179, at 7. 287. jones, supra note 284, at 5-6. 288. id. at 6. 289. id. 290. id. (in one study, “cheerleaders supervised by coaches with the most education, qualifications, and training had a nearly 50% reduction in injury compared to those supervised by coaches with less training.”). 291. praise investigators, supra note 36, at 872. 2019] sex-based disparities in musculoskeletal health care 287 patients,” and should be prepared to handle the issues and complexities surrounding ipv.292 policymakers should consider requiring ipv training similar to child abuse training required for medical licensure in some states.293 board certification should include some assessment of ability to recognize ipv. fracture clinics should improve identification of and response to victims of ipv including offering referral services to people who can provide assistance.294 another example of a musculoskeletal disease where sex-based recognition and treatment is important is osteoporosis—where interestingly males may have the most to gain. postmenopausal women at risk for osteoporosis and hip fracture related to estrogen deficiency should be recognized and treated or referred.295 in addition, orthopedists should recognize that osteoporosis is underdiagnosed in men, and similarly, be aware of its risks—especially considering men’s higher mortality rates associated with hip fractures.296 failure to diagnose osteoporosis in males has important implications to prevent future fractures and to improve longevity.297 second, preoperative surgical decision-making and evaluation should include evaluation of sex-based factors. sex-biased “social determinants of health” should be considered—like (1) socioeconomic and insurance status and (2) whether the person is living alone or serving as a caregiver. in addition, providers should not assume male elective surgery (i.e., “male norm”) rates are correct and should consider whether males or females are currently choosing elective surgeries at the optimum rate. in fact, some studies show that with the use of better education preoperatively through decision aids, many fewer patients choose to proceed with total knee replacement298—so it is possible that the current female rate of tkr is actually closer to the optimum than the male rate, and if the male rate were diminished, the disparities would decrease.299 292. sheila sprague et al., intimate partner partner violence and musculoskeletal injury: injury: bridging the knowledge knowledge gap in orthopaedic fracture clinics, fracture clinics, 14 bmc musculoskeletal disorders 1,8 (2013), https://www.ncbi.nlm.nih.gov/pmc/ articles/pmc3585708/ [https://perma.cc/z7sy-qwn6] (suggesting that orthopedic surgeons in fracture clinics should consider who to include in ipv screening, decide who should ask about ipv, ensure confidentiality and patient safety, and help in the development of social support programs). 293. see, e.g., mandated training related to child abuse, n.y state. st. department educ. dep’t, http://www.op.nysed.gov/training/camemo.htm [https://perma.cc/3sby-cccx].] (last updated april 4, 2017). 294. praise investigators, supra note 36, at 874. 295. wolf et al., supra note 26, at 341. 296. id. at 341-2. 297. id. 298. emily lee, shared decision making to improve care and reduce costs, 368 new eng. j. med. 1 (jan. 3, 2013) (finding that when patients received enhanced preoperative counseling for tkr with decision aids, tkr surgery rates dropped by 38%). 299. celik et al., supra note 3, at 1. 288 indiana health law review [vol. 16:251 in addition, socioeconomic and insurance status can affect whether or not a person opts for an elective surgery–like total knee replacement—and can lead to delays that ultimately negatively impact outcomes because the disease progresses to a point where the treatment it simply less effective. if socioeconomic issues are identified early, appropriate counseling might help some women decide to go ahead with elective surgeries previously outside their financial reach at earlier stages of their disease by revealing sources of assistance that were previously unknown to the patient. also, practical factors like living alone or functioning as a caregiver for a dependent spouse or relative can lead to delays of necessary surgery. women who are living alone or serving as caregivers may need special assistance or planning in order to recover after surgery. early identification of these factors may allow health care providers to alert women to options for postoperative assistance for those living alone and assistance for those serving as caregivers. the medical community’s involvement in developing and promoting support for older women may be helpful in eliminating disparities affecting elective surgery.300 pension reforms and reforms to the supplemental security income and disability insurance benefits (ssi/dib) program to ensure widows who have not worked are not left alone without income after their husband’s death may be important. also, supporting employment opportunities for older women to allow them to remain active and provide income may help eliminate disparities. further, continued trends toward equal pay and equal insurance coverage will likely help eliminate disparities related to socioeconomic differences. also, under the aca’s minimal essential benefits provisions, the gap between coverage obtained through employer-based plans compared to marketplace plans or plans obtained via medicaid is narrowing. therefore, disparities related to differences in insurance coverage (i.e., fewer women on employer-based plans and more on medicaid) differences should diminish. third, sex-based decisions may be necessary during surgery (i.e., intraoperatively). for example, with regard to acl reconstruction, women may not be getting equal results because “[f]emales [are] more likely than males to require further acl surgery and less likely to return to play.”301 some authors suggest that the graft material used in males and females during acl reconstruction surgery may need to be sex-specific.302 the story is a little different and confusing with regard to knee replacement. several studies have shown equal results for standard non-sex-specific total knee 300. supportive older women’s network, helping women discover the power of mutual support as they age, http://www.sown.org/pdf/sown-brochure.pdf [https:// perma.cc/4pc6-lxxc]. 301. carter et al., supra note 1, at 450 (referring to one study of soccer players followed for seven years after acl reconstruction). 302. id. at 447-48 (“for example, the intraoperative choice of an anterior cruciate ligament (acl) autograft is a notable factor in determining return-to-sport and reinjury rates, especially for adolescent females with high quadriceps to hamstring strength ratios.”). 2019] sex-based disparities in musculoskeletal health care 289 implants when comparing the sexes with regard to implant survival/failure.303 research suggests that a gender-specific total knee implant did not result in improved outcomes for women—“although differences between the bony anatomy of the knee joint of men and women are well-documented.”304 a review at the american academy of orthopaedic surgery meeting in 2008 did not “consistently show differences between men and women in most outcomes of tricompartmental total knee replacement surgery” raising questions about the need for a gender-specific implant.305 in addition, a 2011 systematic review revealed that “function and satisfaction scores did not differ with use of genderspecific knee implants when compared to unisex implants.”306 while this specific implant did not seem to make a difference in these studies, with more research, sex-specific knee replacements might eventually make important clinical differences given some of the documented differences in bone and ligament anatomy around the knee in men and women. fourth, postoperative musculoskeletal care may also need to be sex-specific. recognition of differences in pain perception and response may eventually lead to different treatment protocols for postoperative and preoperative pain in men and women with musculoskeletal problems.307 women may perceive pain differently and respond differently to pain medications than men, and therefore, different pain management protocols may be appropriate for women over men.308 sex-based differences in animals and humans have been found in response to the use of opiates and anti-inflammatory medications often used to treat musculoskeletal disorders.309 therefore, preoperative pain recognition and postoperative pain management protocols may need to be modified based upon sex. finally, many other differences may become evident with more research as outlined above. 2. in law and policy: emerging legal issues related to sex-based medical treatment recognition and proper treatment of sex-based differences in musculoskeletal care requires support from the legal community and from policymakers. biologic males and females are different—even beyond the obvious differences involving 303. wolf et al., supra note 26, at 343. 304. id. 305. id. 306. id. at 344. 307. e.j. bartley & r.b. fillingim, sex differences in pain: a brief pain: a brief review of clinical and experimental findings, 111(1) brit. j. anesthesia 52, 52 (2013). 308. kamath et al., supra note 39, at 3359 (noting that women often have worse pain postoperatively than men); tosi, supra note 1, at 1639 (observing that “[d]ifferences in the efficacy of analgesics in men and women have also been described.”). 309. tosi et al., supra note 1, at 1639 (including specifically differences in responses to “mureceptor opiates, kappa-acting opiates, and anti-inflammatory medications . . .”). 290 indiana health law review [vol. 16:251 the reproductive system. as discussed above, failure to recognize biologic differences in female versus male response to disease and treatment has likely led to diminished success in the treatment of both sexes—but especially in women. therefore, it is important for policymakers to acknowledge biologic and other differences between the sexes when it comes to musculoskeletal health care. a. recognizing “real differences” between the sexes under the constitution current sex discrimination doctrines—either constitutional or statutory—generally are considered to recognize formal equality as the standard,310 which usually allows room for medical professionals to properly acknowledge sex-based treatment and training protocols. formal equality requires equal treatment of persons who are similarly situated (e.g., persons who have similar athletic interests).311 the supreme court has recognized real differences between males and females,312 and has “consistently upheld statutes where the gender classification . . . realistically reflects that the sexes are not similarly situated in certain circumstances.”313 “‘real’ differences are defined broadly to include definitional differences, legally created differences, and differences that result from past discrimination against women.”314 the court notes that the equal protection clause “does not ‘demand that a statute necessarily apply equally to all persons’ or require ‘things which are different in fact . . . to be treated in law as though they were the same.”’315 “this approach is also associated with a high degree of tolerance for facially sex-neutral rules that have a disparate impact on one sex.”316 the court also makes clear that “a legislature may ‘provide for the special problems of women.’” 317 however, a “legislature may not ‘make overbroad generalizations based on sex which are entirely unrelated to any differences between men and women or which demean the ability or social status of the affected class.’” 318 therefore, generally speaking, policy initiatives can take into account sex-based differences and allow for different treatment of men and women—even for the same types of issues—so, the proposals mentioned above should generally be permissible. therefore, sex-specific protocols with regard to treatment of female athletes and 310. katharine bartlett, gender law, 1 duke j. gender l. and pol’y 1, 2-4 (1994) (“formal equality is the familiar principle that individuals who are alike should be treated alike, according to their actual characteristics, rather than stereotypical assumptions.”). 311. id. 312. ann freedman, sex equality, sex differences, and the supreme court, 92 yale l.j. 913, 918 (1983); michael m. v. superior court sonoma cty., 450 u.s. 464, 481 (1981). 313. michael m., 450 u.s. at 469. 314. freedman, supra note 312, at 931. 315. michael m., 450 u.s. at 469. 316. freedman, supra note 312, at 931. 317. michael m., 450 u.s. at 469. 318. id. 2019] sex-based disparities in musculoskeletal health care 291 female medicare recipients are likely within the equal protection clause if based upon real differences between men and women. b. development of sex-specific protocols under title ix and hhs rules title ix, implemented in 1972, prohibits discrimination on the basis of sex in educational programs and activities that receive federal funding.”319 title ix led to vastly increased participation in sports by females from fewer than 300,000 female students participating in interscholastic athletics in 1971 to over 2.6 million in 1998-99.320 for perspective, only one in twenty-seven girls played high school sports prior to title ix, whereas by 1998, it was one in three.321 likewise, at the college level, female participation has increased from 32,000 in 1971 to 150,000 in 1998.322 girls and women also are increasingly involved in traditionally male sports like baseball, football, “rugby, boxing, judo, wrestling, body-building, stock car driving, weightlifting, and throwing events.”323 with increased participation, comes increased risk of sports-related injury. title ix compliance includes “the treatment and benefits provided to male and female athletes”—which may arguably include access and quality of musculoskeletal care provided.324 title ix includes a three-part test for measuring discrimination in provision of athletic opportunities to male and female students.325 under title ix, “no person . . . shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving federal financial assistance.”326 the three-part test issued in 1979 means that an institution may comply with title ix by meeting at least one of three benchmarks: (1) whether intercollegiate level participation opportunities for male and female students are provided in numbers substantially proportionate to their respective enrollments; or (2) where the members of one sex have been and are underrepresented among intercollegiate athletes, whether the institution can show a history 319. 20 u.s.c. § 1681 (2018) (“no person in the united states shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving federal financial assistance . . .”). 320. deborah brake, the struggle for sex equality in sport and the theory behind title ix, 34 u. mich. j. l. reform 13, 15 (2001); see also carter, supra note 1, at 448 (stating, “[s]ince the implementation of title ix in 1972, the number of females participating in sports has increased dramatically at all levels of play.”). 321. brake, supra note 320, at 15. 322. id., at 15. 323. id., at 16. 324. id., at 47. 325. id., at 47-8. 326. 20 u.s.c. § 1681(a) (2018) (emphasis added). 292 indiana health law review [vol. 16:251 and continuing practice of program expansion which is demonstrably responsive to the developing interest and abilities of the members of sex; or (3) where the members of one sex are underrepresented among intercollegiate athletes, and the institution cannot show a continuing practice of program expansion such as that cited above, whether it can be demonstrated that the interests and abilities of the members of that sex have been fully and effectively accommodated by the present program.327 really, only the third option addresses obtaining equally effective accommodation of sex-specific musculoskeletal differences—so programs are not obligated under title ix’s three-part test to make sex-based changes to musculoskeletal care . . . unless they fail to meet the other two options. however, some argue that title ix goes beyond formal equality because it can hold institutions accountable for “their role in constructing and perpetuating such differences.”328 title ix’s three-part test is “influenced by structuralism, a theoretical approach which emphasizes the need to critically examine the structures and cultures of institutions that differently situate men and women and result in subordination of women.”329 it may be possible to argue that failure to develop sex-specific protocols discourages participation of women in sports due to their fear of injury, which has led to continued disparities in the number of women participating in athletics compared to men. even with the previously noted gains under title ix, participation disparities still persist; for example, 3.8 million high school males competed in sports compared to only 2.6 million females, and women comprise fifty-three percent of undergraduate college students, but only thirty-seven percent of college athletes.330 “equality” may be another perceived concern when treatment recommendations diverge based upon sexual dimorphism—especially if the treatment for one sex is significantly more expensive or more burdensome than for the other sex. hhs says that “[w]omen must be treated equally with men in the health care they receive . . .”331 “sex-specific health programs or activities are permissible only if the entity can demonstrate an exceedingly persuasive justification, that is, that the sex-specific health program or activity is substantially related to the achievement of an important health-related or scientific objective.”332 when treating the same disease, however, “equally” may not necessarily mean the “same,” because sexual dimorphism may mandate different treatments for the same musculoskeletal issue—as outlined above. sometimes, exceedingly persuasive justifications—like double-blind, randomized 327. title ix and intercollegiate athletics, 44 fed. reg. 71413 (dec. 11, 1979) (to be codified at 45 c.f.r part 86) (emphasis added). 328. brake, supra note 320, at 22. 329. id. at 23. 330. id. at 19. 331. hhs, supra note 12. 332. id. (emphasis added). 2019] sex-based disparities in musculoskeletal health care 293 research studies—simply are hard to find in medicine, even though there is a medical consensus that one treatment is better than the other.333 when treatments fail or become outdated, providers and institutions may become targets for sex discrimination lawsuits accusing them of basing treatment upon “archaic stereotypes,”334 even though the treatment was based upon medical consensus—just as much treatment is based upon medical consensus without “exceedingly persuasive justification,”335 even in modern medicine. physicians must be allowed to acknowledge sex-based differences and treat patients accordingly without fear of reprisals from lawyers based upon accusations of sex discrimination where medical consensus warrants. an alternative analysis to formal equality is “anti-subordination,” which “is as concerned with the perpetuation of existing disadvantages through formally neutral structures as it is with formal barriers to equality.”336 under anti-subordination, the “central question is whether the challenged rule or practice perpetuates the subordination of women.”337 as long as the medical consensus did not somehow subordinate women, it could be justified, even if “exceedingly persuasive justification”338 was lacking, and the treatment later turned out to be suboptimal in retrospect. c. balancing transgender rights with medical need to recognize biologic sex failure to recognize and acknowledge biologic sex-based differences will continue to lead to disparities in musculoskeletal care. this is true, even though societal shifts demanding “non-binary” treatment threaten to label recognition of patients’ biologic sex as discrimination. nonbinary people may identify themselves on a spectrum between male and female, as neither male nor female, as both male and female, or as totally outside of a male-female dichotomy and instead inhabiting a “gender galaxy,” defined as “a three-dimensional non-linear space in 333. institute of medicine, evidence-based medicine and the changing nature of health care: 2007 iom annual meeting summary 49 (the nat’l acad. press 2008) (noting that “recommended care is often not delivered and insufficient evidence often leads to wide practice variations with little to no health benefit to patients”); see also frank griffin, prejudicial interpretation of expert reliability on the “cutting edge” enables the orthopaedic implant industry’s bodily eminent domain claim, 18 minn. j.l. sci. & tech. 207, 254 (2017) (stating, “[o]nly 11.3% of the orthopaedic literature used the most reliable level of evidence (level 1) and only 3% of orthopaedic articles were randomized, controlled trials (the gold standard for clinical research).”). 334. brake, supra note 320, at 25. 335. hhs, supra note 12 (emphasis added). 336. brake, supra note 320, at 27. 337. id. at 28. 338. hhs, supra note 12 (emphasis added). 294 indiana health law review [vol. 16:251 which every gender has a location that may or may not be fixed.”339 however, generally speaking (unless the person has a genetic anomaly) every cell in each person’s body is biologically male or female and the proper treatment of that cell, organ system, and entire body often requires accurate acknowledgement of those basic differences by medical professionals.340 the importance of genetics cannot be overemphasized. twin studies reveal just how important a person’s biologic genetic makeup can be.341 medical charts and physicians communicating with each other regarding patient care should be allowed to communicate biologic sex clearly and protected from claims of discrimination for “misgendering.” certainly, where feasible, medical personnel should also attempt to honor patients’ preferences that do not impact the patient by a preferred sex pronoun as long as it does not disrupt medical care or endanger the patient. however, the landscape is under increasing scrutiny that could make it more difficult for medical professionals to avoid allegations of discrimination. for example, section 1557 of the affordable care act “prohibits discrimination on the grounds of . . . sex . . . in certain health programs and activities” with the “final rule appl[ying] to any health program or activity, any part of which receives funding from” hhs funded entities like medicare and medicaid, which includes activities like physician and hospital interactions with patients.342 “the rule makes clear that sex discrimination prohibited under section 1557 includes discrimination based on . . . sex stereotyping.”343 hhs initially enacted rules including “gender identity” in the definition of sex discrimination in title ix; the rule from section 1557 of the aca defines gender identity as follows: gender identity means an individual's internal sense of gender, which may be male, female, neither, or a combination of male and female, and which may be different from an individual's sex assigned at birth. the way an individual expresses gender identity is frequently called “gender expression,” and may or may not conform to social stereotypes associated with a particular gender. a transgender individual is an individual whose gender identity is different from the sex assigned to that person at birth.344 339. olga tomchin, bodies and bureaucracy: legal sex classification and marriage-based immigration for trans* people, 101 calif. l. rev. 813, 854 (2013) (citation omitted). 340. iom, supra note 1, at 1 (“evidence suggests that the distinct anatomy and physiology that develop as a result of having been dealt two x chromosomes (xx) or an x chromosome and a y chromosome (xy) at fertilization can have a much broader influence on an individual’s health than was previously thought.”). 341. see generally bouchard, supra note 156. 342. hhs, supra note 12. 343. id. 344. 45 c.f.r. § 92.4 (2019). 2019] sex-based disparities in musculoskeletal health care 295 however, the hhs rule including gender identity in the definition of sex discrimination was found to be “contrary to law” and “exceed[ed] statutory authority,” so “the prohibition of discrimination on the basis of ‘gender identity’” was enjoined.345 the court explained: prior to the passage of the aca in 2010 and for more than forty years after the passage of title ix in 1972, no federal court or agency had concluded sex should be defined to include gender identity. accordingly, hhs's expanded definition of sex discrimination exceeds the grounds incorporated by section 1557.346 adding gender identity to the potential legal pitfalls for physicians could potentially lead to less acknowledgment of sex-based differences given the difficult social interactions physicians face daily, with resultant increases in disparities and discrimination against women—so, this injunction potentially helps protect physicians trying to treat patients based upon biologic sex. physicians may be leery of acknowledging sex in some cases because they can be accused of sex stereotyping and/or discrimination on the basis of sex for recognizing and treating patients based upon their biologic sex, instead of their asserted gender. the law in this area is still emerging and can be quite confusing. for example, a california court found that because a hospital’s staff often misgendered a deceased transgender male teen by referring to him as “she” or “her,” the patient’s mother was permitted to recover damages for the deceased’s emotional distress prior to his death, and that under the aca, discrimination of the basis of transgender identity was discrimination “on the basis of sex.”347 yet, under title ix (and similarly under the aca), another court held that sex discrimination “unambiguously refers to ‘the biological and anatomical differences between male and female students as determined at their birth.’”348 the franciscan alliance court concluded that “congress intended to prohibit sex discrimination on the basis of the biological differences between males and females.”349 the issue appears in lay blogs and media and includes allegations that doctors who acknowledge biologic sex are discriminatory. for example, in one article, the author accused the hospital and physicians of discrimination because a transgender teen was misgendered and later committed suicide.350 physicians must be able to recognize and acknowledge biologic sex to 345. franciscan all., inc. v. burwell, 227 f. supp. 3d 660, 695 (n.d. tex. 2016). 346. id. at 689. 347. prescott v. rady children’s hosp.–san diego, 265 f. supp.3d 1090 (s.d. cal. 2017). 348. franciscan all., 227 f. supp. 3d at 687. 349. id. 350. shabab ahmed mirza & caitlin rooney, discrimination prevents lgbtq people from accessing health care, ctr. am. progress, (jan. 18, 2018, 9:00 am), https://www. americanprogress.org/issues/lgbt/news/2018/01/18/445130/discrimination-prevents-lgbtq-peopleaccessing-health-care/ [https://perma.cc/npk2-pvk6]. 296 indiana health law review [vol. 16:251 optimally provide medical care without being accused of discrimination for misgendering someone or of acknowledging medically valid differences between the sexes that some might see as a stereotype. and doctors must be able to treat patients differently based upon sex when medically appropriate—even when treating identical disease processes unlinked to obvious sex differences because without considering biologic sex, the lack of a sex-based link may not have been evident because consideration of sex-based issues is part of the diagnostic and treatment process for all patients. although they might be hesitant to acknowledge it in a socially charged environment, it is possible that medical schools and residency training programs feel some pressure to avoid emphasizing sex differences based upon mixed messages present today in the law and in society. failure to recognize sex-based differences can lead to disparities and discrimination—especially against women for the reasons outlined in this paper. iv. conclusions each individual’s biologic sex plays an important role in his or her experience of musculoskeletal disease, in the physician’s accurate diagnosis of the problem, in the treatment prescribed, and in the ultimate outcome of the experience. significant disparities exist negatively impacting females related to failure of the health care delivery system to recognize and treat sex-based differences—including disparities impacting young, active girls and women, as well as adult and aging women. sometimes failure to recognize sex-based differences also negatively affects males. the medical community has historically been inundated with adoption of male norm in research and male bias in thinking that has likely contributed to disparities impacting females. physicians and other musculoskeletal care providers have largely been undereducated in sex-based differences outside obvious differences related to the reproductive organs and sex hormones. while significant biological differences exist in the musculoskeletal systems of men and women, these biologic differences often fail to account for disparities observed in treatment and outcomes. societal and cultural influences often play a significant role in propagating disparities in musculoskeletal health and health care. to reduce sex-based disparities in musculoskeletal health care, more sexspecific research is needed with an emphasis on development of sex-specific treatment protocols. increased gender diversity of orthopaedic surgeons would also likely help. improved medical education regarding sex-based differences in presentation, diagnosis, treatment, and response to treatment is needed, with continued updating of medical education as research continues to emerge—including recognition of social and cultural factors that contribute to disparities. law and policy makers can help improve sex-based musculoskeletal care by continuing to address gender inequalities affecting socioeconomic status and insurance status. in addition, legal scholars, lawmakers, and the courts should carefully consider law and legal precedent that inhibits physicians’ and providers’ 2019] sex-based disparities in musculoskeletal health care 297 ability to acknowledge and communicate openly their patients’ biologic sex without fear of being accused of sex stereotyping or misgendering. with continued research and attention to sex-based differences in musculoskeletal care, outcomes for all patients are likely to improve in this emerging area. the road to safer streets: tackling the pedestrian & cyclist safety crisis in indianapolis the road to safer streets: tackling the pedestrian & cyclist safety crisis in indianapolis jaden montgomery * i. introduction henry najdeski, a distinguished attorney, embodied success and integrity in his career at barrett mcnagny, an indiana law firm. 1 specializing in real estate law, najdeski's accolades were numerous—listed in the best lawyers in america since 2019, recognized as a “rising star” in the 2009 indiana super lawyers publication, and featured among fort wayne monthly’s “top lawyers.” 2 a loving family, a flourishing career, and a promising future marked his life.3 yet, in april of 2023, tragedy struck. najdeski, while crossing the street in a designated crosswalk with a pedestrian walk sign in downtown fort wayne, was fatally struck by an unmarked police truck driven by sgt. joshua hartup turning left into the crosswalk. 4 sgt. hartup, asserting that he hadn’t seen najdeski, 5 received only a $35.50 fine with an additional $139.50 in court fees. 6 he faced no criminal charges or disciplinary action from the police force. 7 compounding the issue, it was revealed that hartup had been involved in four prior crashes while operating a police vehicle, each classified as “preventable.” 8 remarkably, for all these prior occurrences, which included hitting curbs and ————————————————————————————— * j.d. candidate, 2026, indiana university robert h. mckinney school of law. b.s.b.a. finance 2021, the ohio state university. the author extends his deepest gratitude to nicole berwick and professor lee little for their invaluable guidance throughout the note-writing process, and to the indiana health law review staff for their support. the author also thanks eric holt for his dedication in founding the indy pedestrian safety crisis organization and for his efforts in raising awareness and managing vital community reporting. 1. rex smith et al., coroner rules on death of man hit by police officer’s vehicle, wane, https://www.wane.com/top-stories/update-victim-struck-by-police-officers-vehicle-dies/ [https:// perma.cc/z3l6-7j7z] (last updated apr. 25, 2023, 1:31 pm). 2. id. 3. id. 4. jazlynn bebout, allen county prosecutor finds ‘no criminal liability’ for fwpd officer who struck, killed pedestrian, 21 alive (aug. 8, 2023, 11:18 am), https://www.21alivenews. com/2023/08/08/allen-county-prosecutor-finds-no-criminal-liability-fwpd-officer-who-struckkilled-pedestrian/ [https://perma.cc/tc97-23us]. 5. id. 6. rebecca green, officer fined for traffic violation in fatal pedestrian collision, wfyi indianapolis (aug. 30, 2023), https://www.wfyi.org/news/articles/officer-fined-for-trafficviolation-in-fatal-pedestrian-collision [https://perma.cc/cy2q-uc5v]. 7. jamie duffy, fort wayne police officer involved in pedestrian fatality pleads guilty to failure to yield, wane, https://www.wane.com/top-stories/fort-wayne-police-officer-involvedin-pedestrian-fatality-pleads-guilty-to-failure-to-yield/ [https://perma.cc/425z-zktg] (last updated aug. 30, 2023 10:38 am). 8. jazlynn bebout, 21 investigates: new documents detail past letters of reprimand filed against fwpd officer police say hit, killed pedestrian, 21 alive (may 10, 2023, 9:57 am), https://www.21alivenews.com/2023/05/10/21investigates-new-documents-detail-past-lettersreprimand-filed-against-fwpd-officer-police-say-hit-killed-pedestrian/ [https://perma.cc/zsu2uzhy]. https://perma.cc/zsu2 https://www.21alivenews.com/2023/05/10/21investigates-new-documents-detail-past-letters https://perma.cc/425z-zktg https://www.wane.com/top-stories/fort-wayne-police-officer-involved https://perma.cc/cy2q-uc5v https://www.wfyi.org/news/articles/officer-fined-for-traffic https://perma.cc/tc97-23us https://www.21alivenews https://www.wane.com/top-stories/update-victim-struck-by-police-officers-vehicle-dies indiana health law review [vol. 22:155 156 concrete poles, hartup faced more significant disciplinary measures—receiving letters of reprimand, undergoing mandatory remedial driver's training, and even a suspension. 9 the outcome here is clear: hartup faced harsher penalties for damaging property than for taking a pedestrian’s life. 10 the story of najdeski's untimely death serves as a poignant illustration of a systemic problem demanding urgent reform. while his story garnered attention due to his prominence, countless similar incidents involving people who are low-income or face other disadvantages go unnoticed. in indianapolis alone, the numbers reveal a stark reality: only fifteen out of sixty-eight fatal crashes involving pedestrians or cyclists in 2020 and 2021 led to criminal charges. 11 this note aims to shed light not only on the specific injustices encountered by individuals such as henry najdeski, but also on the widespread issue of disregard for the safety of vulnerable road users. it's a troubling trend where accidents involving pedestrians and cyclists are frequently dismissed as unpreventable. 12 this perspective is not limited to the fort wayne police department; it's a viewpoint often echoed by public officials and policymakers throughout the state. such attitudes reveal a broader, institutionalized indifference towards ensuring the safety of those most at risk on our roads. while some attribute these incidents to the inevitabilities of our car-centric society, numerous cities, states, and countries have proven such collisions are preventable. 13 proposing a comprehensive reevaluation of indiana's protections for pedestrians and cyclists, this note advocates for reforms in criminal and civil liability, improved enforcement, and enhanced infrastructure. to navigate through the complexities of the pedestrian and cyclist safety crisis, this note unfolds in a structured manner. it first examines the nationwide crisis, comparing that with the specific challenges faced in indianapolis. this sets the stage for an in-depth examination of the root causes contributing to the pedestrian and cyclist safety crisis in central indiana, where factors such as increased walking and cycling trends, vehicle miles traveled, and poor driver behaviors are scrutinized, along with policy-driven challenges including deficiencies in traffic enforcement and infrastructural shortfalls. shifting focus, the subsequent section proposes actionable solutions, advocating for a strategic mix of traffic law enforcement enhancements, infrastructure improvements, and legislative reforms, with each evaluated for their potential impact and feasibility. recognizing the intricacies of policy implementation, the narrative also delves into the legislative hurdles that pose impediments to progress, giving insight into the complex policy landscape. the conclusion underscores the necessity for indianapolis to secure dedicated funding for pedestrian safety ————————————————————————————— 9. id. 10. id. 11. kayla dwyer, people keep dying in crashes on indianapolis streets. what can actually be done about it?, ind. star, may 9, 2022. 12. bebout, supra note 8. 13. gregory h. shill, regulating the pedestrian safety crisis, 97 n.y.u. l. rev. 194, 200 (2022). 2025] the road to safer streets 157 initiatives, effectively enforce the rules of the road, bridge infrastructural gaps that disproportionately endanger vulnerable road users, and rethink the carcentric legal framework by altering laws that disadvantage pedestrians and cyclists. a. nationwide crisis: pedestrian and cyclist safety concerns in the broader context of the nationwide crisis surrounding pedestrian and cyclist safety, the alarming surge in crashes leading to injuries and fatalities transcends the boundaries of indiana. in 2018, the united states experienced the highest number of pedestrian deaths in a generation, with pedestrian fatalities escalating by 50% over the past decade. 14 concurrently, cyclist fatalities surged by 38% during the same period.15 data released in june of 2023 by the national highway traffic safety administration (nhtsa) reveals a trend of rising pedestrian and cyclist casualties due to traffic crashes. 16 a traffic crash is defined as “an incident that involve[s] one or more [] vehicles in-transport that originated on or had a harmful event (injury or damage) on a public traffic way, such as a road or highway.” 17 a pedestrian is defined as “any person on foot, walking, running, jogging, hiking, sitting, or lying down” who is involved in a motor vehicle traffic crash. 18 according to the nhtsa, in 2021 there were 7,388 pedestrians killed in traffic crashes, a 12.5% increase from the 6,565 pedestrian fatalities in 2020. 19 this is the highest number since 1981 when 7,837 pedestrians died in traffic crashes. 20 in addition, in 2021 there were an estimated 60,577 pedestrians injured in traffic crashes, an 11% increase from 54,771 pedestrians injured in 2020.21 the situation is also alarming for pedal cyclists, defined as bicyclists and other cyclists including riders of two-wheel, non-motorized vehicles, tricycles, and unicycles powered solely by pedals. 22 in 2021 there were 966 pedal cyclist fatalities, accounting for 2.2% of all traffic fatalities that year. 23 moreover, in 2021 an estimated 41,615 pedal cyclists were injured, a 7% increase from 38,886 pedal cyclists injured in 2020. 24 in sum, the 2021 data displays that traffic crashes claimed the lives of 8,354 pedestrian and pedal cyclists, and ————————————————————————————— 14. angie schmitt, right of way 2 (2020). 15. id. 16. u.s. dep’t of transp., pedestrians traffic safety facts 2021 data 2 (2023). 17. id. 18. id. at 1. 19. id. 20. id. 21. id. 22. u.s. dep’t of transp., bicyclists and other cyclists traffic safety facts 2021 data 1 (2023). 23. id. 24. id. indiana health law review [vol. 22:155 158 injured another 102,192. angie schmitt, a leading expert and advocate for sustainable transportation, described the surge in pedestrian and cyclist deaths as “a mounting crisis,” that was “so unexpected and unusual that for a long time, experts dismissed it as . . . an aberration.” 25 however, as the pedestrian and cyclist deaths and injuries have continued to grow, quickly outpacing growth of driver and passenger fatality rates, it is now clear that pedestrians and cyclists are part of a fast-growing and frequently-overlooked epidemic. 26 the danger to pedestrians and cyclists in the u.s. has risen significantly since 2010, but this cannot be explained only by the less than 10% increase in vehicle miles traveled or the 6.14% population growth during the same period. 27 this trend also cannot be simply categorized as part of a global trend; on the contrary, it is a global outlier. 28 as gregory h. shill, who is professor of law at the university of iowa college of law and a transportation policy expert, observed in a 2022 law review note titled “regulating the pedestrian safety crisis”, “the dismal state of u.s. pedestrian safety contrasts sharply with the significant reductions in pedestrian deaths achieved by peer nations during a comparable window.” 29 most importantly, the pedestrian and cyclist safety crisis exhibits a pattern of discrimination. data reveals these tragedies disproportionately impact marginalized groups, specifically people of color and individuals in low-income communities who rely on walking and biking for transportation. 30 the death rates from such collisions vary significantly by race and ethnicity, as shown in figure 1. figure 1: age-adjusted death rates for pedestrians involved in a collision with a motor vehicle by race and ethnicity (per 100,000 standard population) in 202131 race/ethnicity death rate american indian or alaska native 8.2 black or african american 4.4 hispanic or latino 3.0 white 1.9 asian 1.4 ————————————————————————————— 25. schmitt, supra note 14. 26. id. 27. shill, supra note 13, at 200. 28. id. 29. id. 30. schmitt, supra note 14. 31. ctrs. for disease control and prevention, quickstats: age-adjusted death rates for pedestrians involved in a collision with a motor vehicle, by race and hispanic origin – national vital statistics system, united states, 2021, 72 morbidity & mortality wkly. rep. 670, 670 (2023). this graph was created by the author using the statistics provided in the cited article. 2025] the road to safer streets 159 the cdc report on pedestrian collision death rates by race and hispanic origin for 2021 paints a clear picture: marginalized groups, especially american indian, alaska native, and black or african americans, are disproportionately affected by these tragedies. in 2021, the pedestrian death rate for american indian or alaska native persons was more than four times higher than that for white persons, and the rate for black or african american persons was more than twice as high. 32 these disparities reflect the systemic barriers and risks that minorities face when accessing safe pedestrian and cyclist infrastructure. 33 the nationwide crisis surrounding pedestrian and cyclist safety demands immediate attention and comprehensive solutions. the surge in injuries and fatalities, as highlighted by nhtsa, transcends state borders and constitutes a fast-growing, frequently overlooked epidemic, as aptly described by angie schmitt. the crisis, when viewed through the lens of discrimination against marginalized groups, emphasizes the need for equitable and sustainable solutions. gregory h. shill's comparison with peer nations emphasizes the failure of the u.s. to align with global trends. as the note’s focus shifts to indiana, the urgency for localized and targeted interventions becomes even more evident. the state-specific examination acts as a detailed reflection of the broader problem, underscoring the critical need for wide-ranging policy reforms. b. localizing the issue: the elevated pedestrian safety crisis in indiana in central indiana, comprising the eight-county region of marion, hamilton, hancock, shelby, johnson, morgan, hendricks, and boone, the indianapolis metropolitan planning organization witnessed a staggering 30% surge in fatal crashes from 2019 to 2020, far outpacing the national average of 6.8%. 34 this trend is especially strong in marion county, the most populous county in the state and home to indianapolis. as figure 2 shows, marion county had the highest pedestrian fatality rate per 100,000 in the state and the nation every year since 2018. ————————————————————————————— 32. id. 33. schmitt, supra note 14. 34. kayla dwyer, in indianapolis fatal pedestrian crashes, 2022 has outpaced 2021. what’s being done?, indy star, https://www.indystar.com/story/news/local/transportation/ 2022/08/10/2022-may-be-deadliest-year-yet-for-pedestrians-on-indianapolis-streets/65393508 007/ [https://perma.cc/w5p3-5nc9] (last updated aug. 10, 2022, 9:21 am). https://perma.cc/w5p3-5nc9 https://www.indystar.com/story/news/local/transportation indiana health law review [vol. 22:155 160 figure 2: pedestrian fatality rate per 100,000 for marion county, indiana, and the united states, 2018-202035 year marion county indiana united states 2016 1.90 1.31 1.31 2017 2.21 1.80 2.27 2018 2.81 1.96 2.35 2019 2.70 1.62 2.34 2020 4.30 1.72 2.38 2021 3.60 2.06 2.71 data in chart represents crude fatality rates per 100,000 population sourced from the centers for disease control and prevention. fatality rates are based on reported fatal incidents of pedestrians involved in collisions with motor vehicles. in 2021, the marion county’s rate of 3.6 pedestrian fatalities per 100,000 individuals was nearly double the state’s rate of 2.06 and 1.3 times higher than the nation’s rate of 2.71. 36 2020 was even worse, with marion county experiencing pedestrian fatalities at a rate 2.5 times the state of indiana and 1.8 times higher than the nation. 37 furthermore, indystar reporter kayla dwyer found that “nearly twice as many severe crashes occur in . . . census areas where the population rate of historically disadvantaged populations exceeds the regional rate, than in other parts of central indiana.” 38 dwyer used police reports and census data to examine the spatial disparity and the impact of pedestrian crashes on historically disadvantaged populations in indianapolis. subsequently, it comes as no surprise that indianapolis’s pedestrian safety ranking is notably low among major u.s. cities—a fact corroborated by a kuru footwear study which ranked indianapolis the tenth most dangerous city for pedestrians in the united states. 39 this study considered indianapolis’s walkability score and the number of pedestrian fatalities across the state in 2024.40 across the entire state, preliminary data for 2022 shows a 20.10% ————————————————————————————— 35. web-based inj. statistics query & rep. sys. (wisqars), explore fatal injury data visualization, ctrs. for disease control & prevention, https://wisqars.cdc.gov/explore/?o= mort&y1=2021&y2=2021&g=00&t=0&i=0&m=20810&d=&s=0&r=0&me=0&ry=0&yp=65 &e=0&a=all&a1=0&a2=199&g1=0&g2=199 [https://perma.cc/e5jq-72rb] (last visited nov. 12, 2024) (the author used the fatal injury explore tool to sort by year, state, country, and cause of death. this tool excludes pedacyclists). this graph was created by the author using statistics provided in the cited source. 36. id. 37. id. 38. dwyer, supra note 34. 39. how safe are u.s. cities for pedestrians? see if your city made the list in our 2024 rankings, kuru footwear blog, https://www.kurufootwear.com/blogs/articles/safest-andmost-dangerous-cities-for-pedestrians [https://perma.cc/72qt-jefg] (last updated sept. 16, 2024). 40. id. https://perma.cc/72qt-jefg https://www.kurufootwear.com/blogs/articles/safest-and https://perma.cc/e5jq-72rb https://wisqars.cdc.gov/explore/?o 2025] the road to safer streets 161 increase in pedestrian fatalities when compared to 2021. 41 compared to other states, indiana faced the 13th largest pedestrian fatality increase in the u.s. 42 while the total number of incidents may seem relatively small because “accidents involving a pedestrian account for 1% of accidents in indianapolis, they make up 20% of all fatalities involving a vehicle.” 43 further, published numbers are often incomplete and fail to fully represent the breadth of the issue. police track and record incidents only where a police report is filed, which does not happen with every accident.44 local pedestrian safety advocates created the indianapolis pedestrian and bicyclist safety crisis dashboard to expose the reality of the problem by tracking and recording all reported crashes involving pedestrians and bicyclists that have been called into emergency services. 45 throughout 2023, the organization recorded 684 incidents, defined as “a crash between a person driving a vehicle and a person walking or biking.” 46 of the 684 total incidents, forty-seven were fatal, while the remaining 637 were nonfatal. 47 in addition, “[t]otal fatalities increased from forty-five in 2022 to fortyseven in 2023. this ties 2020 for the year with the most total pedestrian and bicyclist fatalities in indianapolis.” 48 the escalating pedestrian and cyclist safety crisis in central indiana, particularly marion county, requires immediate attention. the surge in fatal crashes, surpassing national averages, illuminates the urgency of this issue. disparities in impact, notably affecting minority populations, emphasize the need for change. as the crisis’s background and causes are explored in the next section, the call to action from the indy pedestrian and bicyclist safety crisis is clear: “while our elected leaders continue to downplay the severity of pedestrian and bicyclist safety issues in indianapolis, the data does not lie: this crisis is continuing to worsen. it is beyond time our leaders step up and treat this crisis with the urgency it deserves.” 49 ————————————————————————————— 41. kara macek, pedestrian traffic fatalities by state: january – june 2022 preliminary data, governors highway safety ass’n 1, 5 (2023), https://www.ghsa.org/sites/default/files/ 2023-02/ghsa%20pedestrian%20traffic%20fatalities%20by%20state%2c%20january-june %202022%20preliminary%20data.pdf [https://perma.cc/pww4-sctd]. 42. id. 43. connectivity fund, indygo [https://perma.cc/7t53-nvhq] (last visited oct. 11, 2023). 44. meredith hackler, indianapolis pedestrians, organizations raise awareness of vehicles driving on the monon trail, wrtv indianapolis, https://www.wrtv.com/news/publicsafety/indianapolis-pedestrians-organizations-raise-awareness-of-vehicles-driving-on-themonon-trail [https://perma.cc/mt9d-dute] (last updated july 16, 2023, 11:18 pm). 45. see generally 2023 indianapolis pedestrian and bicyclist safety analysis, indy pedestrian/bicyclist safety crisis (jan. 30, 2024), https://indypedcrisis.info/assets/ downloads/2023_indianapolis_pedestrian_and_bicyclist_safety_analysis.pdf [https://perma.cc/ hvt2-snum]. 46. id. at 2. 47. id. 48. id. at 6. 49. id. at 7. https://perma.cc https://indypedcrisis.info/assets https://perma.cc/mt9d-dute https://www.wrtv.com/news/public https://perma.cc/7t53-nvhq https://perma.cc/pww4-sctd https://www.ghsa.org/sites/default/files indiana health law review [vol. 22:155 162 ii. background – causes of the crisis in central indiana a. increase in walking, cycling, and public transportation the surge in walking and cycling in the us reflects a positive shift towards sustainable transportation. between 2019 and 2022, the average daily bike trips in the nation rose by 37%, with a substantial spike occurring in 2020. 50 similarly, the indianapolis metro area witnessed a 37.5% increase in cycling trips during the same period. 51 these trends indicate a growing demand and preference for active modes of transportation that are healthier, cheaper, and more environmentally friendly than driving. 52 however, walking and cycling are not only personal choices; they are also influenced by the availability and quality of public transit. for many indianapolis residents, especially those who do not own a car, public transit is a vital lifeline that connects them to jobs, education, health care, and other essential services. 53 approximately 30,000 households in marion county do not own a car, which is nearly three times as many as all the counties bordering it combined. 54 for these households, walking or cycling to and from indygo transit stops is often the only option to access their destinations. 55 recognizing the importance and potential of public transit, marion county voters approved a transit tax referendum in 2016, authorizing a 0.25% income tax hike to fund indygo’s transit plan. 56 this plan aimed to enhance the frequency, reliability, and coverage of the transit system through enhanced service which includes the implementation of three bus rapid transit (brt) lines: the red line, the purple line, and the blue line. 57 brt is a high-capacity, high-frequency mode of transit utilizing dedicated lanes, level boarding, off————————————————————————————— 50. casey lewis, erin o’higgins & emily adler, bike boom or bust? ranking u.s. metros & states by cycling activity, streetlight 5 (2023) https://learn.streetlightdata.com/ranking-usbicycle-count-trends [https://perma.cc/a36g-j9zy]. 51. alex fitzpatrick & alice feng, america’s bicycling hot spots, mapped, axios (oct. 12, 2023), https://www.axios.com/2023/10/12/biking-cities-bike-friendly-bicycle-us-map?utm_ source=newsletter&utm_medium=email&utm_campaign=newsletter_axioswhatsnext&stream=s cience [https://perma.cc/y23m-lgsg]. 52. lewis, o’higgins & adler, supra note 50. 53. sydney dauphinais, commuting problems: central indiana’s lack of public transportation limits access to good jobs, wyfi indianapolis (june 8, 2022), https://www. wfyi.org/news/articles/commuting-problems-central-indianas-lack-of-public-transportationlimits-access-to-good-jobs#:~:text=not%20everyone%20in%20central%20indiana,households %20do%20not%20have%20vehicles [https://perma.cc/r7hj-rnrz]. 54. id. 55. see generally mission and values, indygo https://www.indygo.net/about-indygo/ mission-and-values/ [https://perma.cc/d5ge-yrfv] (last visited jan. 28, 2024). 56. john tuohy, supporters declare victory for mass transit tax hike in marion county, indystar, https://www.indystar.com/story/news/politics/2016/11/08/marion-county-votersconsider-tax-hike-mass-transit/93284726/ [https://perma.cc/gjk3-a84k] (last updated nov. 9, 2016, 3:20 pm). 57. id. https://perma.cc/gjk3-a84k https://www.indystar.com/story/news/politics/2016/11/08/marion-county-voters https://perma.cc/d5ge-yrfv https://www.indygo.net/about-indygo https://perma.cc/r7hj-rnrz https://wfyi.org/news/articles/commuting-problems-central-indianas-lack-of-public-transportation https://www https://perma.cc/y23m-lgsg https://www.axios.com/2023/10/12/biking-cities-bike-friendly-bicycle-us-map?utm https://perma.cc/a36g-j9zy https://learn.streetlightdata.com/ranking-us 2025] the road to safer streets 163 board fare collection, and traffic signal priority to provide faster, safer, and more convenient service than traditional buses. 58 the red line launched in 2019 and has been a success story for indygo, evident from the 12.9% increase in ridership from 2021 to 2022, totaling over 1.6 million trips. 59 brt encourages more people to utilize public transit, bringing with it a rise in individuals walking and cycling to and from transit stations, as “transit riders start and end every trip as pedestrians.” 60 the second brt line, the purple line, which is expected to launch in late 2024, will bring essential infrastructure improvements, such as sidewalks, bike lanes, drainage, and curbs, to the neighborhoods along the route. 61 the third and final brt line, the blue line, which is planned to launch in 2027, will run east-west along washington street from cumberland to the indianapolis international airport. 62 the blue line plans also include a multitude of benefits to pedestrians and cyclists, in the form of approximately 359 new or replaced ada curb ramps, 9.7 miles of new or replaced sidewalks, and 2.3 miles of new or refreshed crosswalks.63 unfortunately, major projects put on by the city often experience challenges and battles with the state of indiana to implement. for example, a bill in the indiana state legislature, authored by state senator aaron freeman (r-indianapolis), threatened to prohibit public transportation projects from utilizing dedicated lanes, a crucial element for planned federal funding for the blue line. 64 walking, cycling, and public transit have gained popularity in central indiana, but the hesitation to respond to this shift has left many vulnerable. as more people walk, cycle, or give up cars due to rising costs or personal choice, they find themselves without adequate protections. projects that would improve safety face criticism because losing a lane of traffic is seen as too high a price to pay. episodes like senator aaron freeman’s attempt to block a city-approved project due to the removal of car lanes on one of the city’s most dangerous streets illustrate the persistence of car-centric culture. ————————————————————————————— 58. bus rapid transit, fed. transit admin., https://www.transit.dot.gov/researchinnovation/bus-rapid-transit [https://perma.cc/ndc7-58pu] (last updated aug. 26, 2024). 59. indygo, january board of directors & board of finance meeting book 169 (2023). 60. purple line, indygo, https://www.indygo.net/purple-line/ [https://perma.cc/w68zdz53] (last visited feb. 3, 2024). 61. id. 62. blue line, indygo, https://www.indygo.net/blue-line/ [https://perma.cc/p4p8-usz8] (last visited feb. 3, 2024). 63. id. 64. s.b. 52, 124th gen. assemb., 2d reg. sess. (ind. 2024). https://perma.cc/p4p8-usz8 https://www.indygo.net/blue-line https://perma.cc/w68z https://www.indygo.net/purple-line https://perma.cc/ndc7-58pu https://www.transit.dot.gov/research indiana health law review [vol. 22:155 164 b. increase in vehicle miles traveled (vmt) figure 3: indianapolis driver data65 year vehicle miles traveled (all vehicles) % change 2016 6,612,675 0% 2017 6,716,260 2% 2018 6,666,493 -1% 2019 6,790,615 2% 2020 6,113,919 -10% 2021 6,644,752 9% 2022 7,938,444 19% chart displays total vehicle miles traveled (vmt) for all cars driving on indianapolis roads and the percentage change in vmt year over year from 2016-2022. vehicle miles traveled (vmt) serves as a key metric for assessing traffic safety, providing insight into the exposure to potential crashes. a single car driving one mile down a road constitutes one vehicle mile traveled. 66 figure 3 shows the vmt for all vehicles in indianapolis from 2016 to 2022, along with the percentage change from the previous year. notably, a contributing factor to the ongoing crisis is the sharp post-covid increase in vmt in indianapolis. in 2022 alone, vehicles within the city covered a record-breaking 7,938,444 miles, reflecting a substantial 19% increase from 2021. 67 this surge in driving heightens the risk for pedestrians and cyclists, who face increased vulnerability to serious injuries and fatalities in the event of a collision. however, vmt alone does not offer a comprehensive explanation for the uptick in collisions. for instance, in 2020 with a 10% reduction in vmt, there was a paradoxical thirty percent increase in fatal crashes. 68 this highlights the importance of considering that the culmination of multiple factors such as driver behavior, increase in walking and cycling, access to public transit, infrastructure, and enforcement, all play a crucial role in determining the level of safety on the streets. ————————————————————————————— 65. mileage and daily vehicle miles traveled (dvmt) by year, county, city, and functional classification, ind. dep't of transp., https://www.in.gov/indot/files/historic invmt-bycityandfunctionalclass-2015-2022-20230807.xlsx [https://perma.cc/gwk3-8esn] (last visited nov. 12, 2024). this graph was created by the author using statistics found in the cited source.. 66. id. 67. id. 68. dwyer, supra note 34. https://perma.cc/gwk3-8esn https://www.in.gov/indot/files/historic 2025] the road to safer streets 165 c. driver behavior trends in the post-pandemic era since 2020, distracted driving, aggressive driving, drowsy driving, and impaired driving have all been on the rise. 69 according to the american automobile association traffic safety index, “driver’s risk-taking behaviors were associated with their perceived danger and social disapproval of the behavior.” 70 a noteworthy discovery from the index indicates that half of respondents acknowledged exceeding the speed limit by 15 mph in the past thirty days.71 based on this self-admission of frequent speeding, it comes as no surprise that only 45% of respondents supported a policy employing cameras to automatically ticket drivers exceeding the speed limit by 10 mph in residential areas. 72 this reluctance shows that people are comfortable with speeding because they rarely face consequences. speed cameras challenge that comfort, threatening their ability to break the law without repercussions. the pandemic played a significant role in exacerbating bad driving behavior. during lockdowns, the period of empty roadways inadvertently fostered a culture of not just speeding but “extreme speeding,” defined as exceeding the speed limit by more than 20 mph. 73 this was compounded by police reluctance to engage with drivers for fear of infection, creating a sense of impunity among drivers surrounding breaking traffic laws. 74 moreover, studies reveal a surge in alcohol consumption during the pandemic, 75 contributing to a 5% increase in vehicular deaths related to both speeding and alcohol in 2022. 76 pre-pandemic factors, notably distracted driving and cellphone use, continue to persist which further contributes to the poor driving behaviors. 77 ————————————————————————————— 69. aaa found. for traffic safety, 2021 traffic safety culture index 6 (2022). 70. id. at 7. 71. id. at 16. 72. id. at 18. 73. alvin powell, drivers who are frustrated, distracted, mad — and somewhat rusty, harv. gaz. (july 6, 2022), https://news.harvard.edu/gazette/story/2022/07/drivers-who-arefrustrated-distracted-and-rusty/ [https://perma.cc/n2kt-ewqb]. 74. id. 75. megan e. slater & hillel r. alpert, surveillance report #120 apparent per capita alcohol consumption: national, state, and regional trends, 1977–2021 1 (2023) (report sponsored by the national institute on alcohol abuse and alcoholism). 76. powell, supra note 73. 77. id. https://perma.cc/n2kt-ewqb https://news.harvard.edu/gazette/story/2022/07/drivers-who-are indiana health law review [vol. 22:155 166 figure 4: pedestrian severe injuries based on vehicle speed78 vehicle impact speed (mph) 16 23 31 39 46 average risk of severe injury for pedestrians struck 10% 25% 50% 75% 90% as speeding becomes ingrained in driver behavior, it is crucial to examine the pivotal role vehicle speed has in a pedestrian or cyclist collision. figure 4 illustrates the severity at varying impact speeds, with a 50% risk of severe injury at 31 mph—a common speed on city streets. if a driver exceeds the speed limit by 9 mph, pedestrians face a 75% risk of severe injury. figure 5: pedestrian deaths based on vehicle speed79 vehicle impact speed (mph) 23 32 42 50 58 average risk of death for pedestrians struck by a vehicle 10% 25% 50% 75% 90% figure 5 shifts the focus to the stark reality of pedestrian deaths based on vehicle speed. at 32 mph, pedestrians face a 25% risk of death, escalating to a 50% risk if a driver exceeds the speed limit by 10 mph. these statistics underscore the unforgiving nature of increased vehicle speeds, especially at a time when half of drivers admit to exceeding speed limits by 15 mph regularly. 80 these rates, presented as averages, can vary based on the victim's age. for instance, “the average risk of severe injury or death for a 70-year-old pedestrian struck at 25 mph aligns with the risk for a 30-year-old pedestrian struck at 35 mph”81—highlighting the heightened vulnerability of the elderly in these situations. what seems like a minor increase in speed to drivers can mean the difference between life and death for pedestrians, especially for the most vulnerable. in their pursuit of saving a few seconds, drivers are casting aside the safety and lives of those not in a car. in response to the surge in reckless driving behaviors and fatal vehicle collisions, the indianapolis city-county council created a fatal crash review ————————————————————————————— 78. brian c. tefft, impact speed and a pedestrian’s risk of severe injury or death 11 (2011) (report sponsored by the aaa foundation for traffic safety). this graph was created by the author using statistics provided in the cited source. 79. id. this graph was created by the author using the statistics provided in the cited article. 80. aaa found. for traffic safety, supra note 69, at 6. 81. tefft, supra note 78, at 9. 2025] the road to safer streets 167 board in 2022. 82 however, according to one of the board appointees, most fatal crashes involving vehicles in indianapolis are caused by drivers breaking traffic laws. 83 minutes from a meeting of the board highlight the ongoing problem, with the board attributing numerous fatalities to "reckless driving" without making actionable recommendations or addressing preventive measures. 84 this highlights the pressing need for stronger and more consistent enforcement of traffic laws to combat reckless driving. d. policy-driven challenges in indianapolis: impact on traffic enforcement and street infrastructure 1. critical gaps in indianapolis traffic enforcement a significant contributor to the crisis in central indiana is the lack of traffic enforcement by the indiana metropolitan police department (impd), particularly post-pandemic. impd’s chief of police chris bailey has acknowledged a notable decline in the robustness of impd’s traffic unit, which now predominantly focuses on managing sporting events and conventions. 85 this shift translates to fewer officers patrolling the streets and enforcing traffic laws, including speeding, running red lights, and driving under the influence. between 2017 and 2021, indianapolis had a decrease of twenty sworn officers in the impd, despite the city’s population growing by 55,818 over the same period.86 in 2021, the total number of sworn officers fell to eighty-seven officers below the allocated force strength of 1,743. 87 with a change in focus and a declining force, it is unsurprising that drivers feel emboldened to violate traffic laws. a key indicator of the level of traffic enforcement in indianapolis is reflected in the number of traffic tickets issued by impd. unfortunately, this critical data is not readily available to the public, and it must be obtained by submitting a lengthy records request or aggregating the tickets available in yearly reports from all six of the impd districts covering indianapolis. in 2017, ————————————————————————————— 82. eric graves, fatal crash review board trying to make indy safer as crash deaths grow, fox 59, https://fox59.com/news/fatal-crash-review-board-trying-to-make-indy-safer-ascrash-deaths-grow/ [https://perma.cc/t8ml-dafv] (last updated dec. 6, 2022, 10:46 pm). 83. id. 84. see generally indianapolis fatal crash review comm’n, meeting minutes and report (2022) (minute meeting report from the august 24, 2022 and november 15, 2022 meetings of the commission). 85. vic ryckaert, traffic deaths increasing statewide as fewer officers ticket drivers in indianapolis, wrtv indianapolis (aug. 17, 2023, 4:45 pm), https://www.wrtv.com/news/ local-news/crime/traffic-deaths-increasing-statewide-as-fewer-officers-ticket-drivers-inindianapolis [https://perma.cc/799s-aglt]. 86. see indianapolis metro. police dep’t, 2017 annual report 44 (2017) [hereinafter 2017 report] ; indianapolis metro. police dep’t, 2021 annual report 5–6 (2021) [hereinafter 2021 report]. 87. 2021 report, supra note 86, at 6. https://perma.cc/799s-aglt https://www.wrtv.com/news https://perma.cc/t8ml-dafv https://fox59.com/news/fatal-crash-review-board-trying-to-make-indy-safer-as indiana health law review [vol. 22:155 168 impd issued 31,602 total “traffic tickets”. 88 the annual report did not specify the type of tickets issued. while subsequent yearly breakdowns are unavailable, two reports from 2022 show the total number of combined traffic citations and warnings for the majority of 2022, totaling 29,377. 89 even without the breakdown of citations versus warnings in the 2022 total, this source of data suggests a decline in ticketing activity compared to 2017. figure 6: impd provided ticket totals90 total traffic citations issued total no-turn on red violations issued year tickets year tickets 2018 34069 2018 1225 2019 38980 2019 1047 2020 30259 2020 1199 2021 29018 2021 203 2022 37519 2022 1106 2023 33873 2023 376 note: the term “traffic citation” refers to a single instance of issuing a ticket. each citation is counted individually, and this figure does not encompass multiple violations that could be associated with a single citation. further examination through a public records request unveils more specific data on citations from 2018 to 2023, including those for no-turn-on-red violations (ntor), as depicted in figure 6. on june 5, 2023, the indianapolis city-county council passed a general ordinance, establishing “pedestrian safety priority areas” and ntor restrictions in intersections to improve pedestrian safety.91 the decrease in issued violations in 2023, despite nearly 100 ————————————————————————————— 88. 2017 report, supra note 86, at 45–46. 89. see indianapolis metro. police dep’t, traffic violator race and sex by officer years of service and race and sex january 1, 2022 june 30, 2022 1–2 (2022); see also indianapolis metro. police dep’t, traffic violator race and sex by officer years of service and race and sex july 1, 2022 september 30, 2022 1–2 (2022). 90. see generally indianapolis metro. police dep’t, request for traffic citation data (2018– 2023) (unpublished data) (on file with the author). this graph was created by the author using statistics from the cited source. 91. indianapolis, ind., city-county council, gen. ordinance no. 27 (2023). 2025] the road to safer streets 169 new ntor intersections being implemented across the city, 92 points to a major enforcement deficit. this is especially concerning given the city’s acknowledgment that 57% of downtown pedestrian crashes stem from vehicles failing to yield to pedestrians crossing the road. 93 although city leaders initially expressed reservations about adopting the ordinance without a concrete plan for its enforcement, they reassured constituents that there was federal funding allocated to impd specifically for policing ntor infractions. 94 despite these assurances, the subsequent decline in enforcement suggests that these commitments were never truly fulfilled. this cycle reveals a systemic lack of accountability. drivers feel emboldened to break the law without consequences, while municipal actors offer empty solutions to rising pedestrian deaths. the city creates task forces that identify reckless driving as a cause of pedestrian deaths and passes de jure ordinances to enforce driving laws in response, yet, when those laws are not enforced and a pedestrian is subsequently killed, city officials can maintain, "[w]e passed a law to help," and police respond, "[w]e need more resources," which leaves all parties unaccountable. ultimately, drivers continue to violate traffic laws unchecked, and every party involved avoids responsibility—except the pedestrian, who pays with their life. 2. the state of sidewalks in indianapolis indianapolis has a substantial shortage of sidewalks, a challenge amplified by the extensive road network the city must maintain in marion county. in addition, because of indiana’s income tax system, which directs taxes to residents’ counties rather than where they work, 95 many commuters utilize city infrastructure without contributing to its maintenance. constrained by limited resources and competing priorities, sidewalks in the city have endured decades of neglect.96 this has resulted in streets either lacking sidewalks altogether or experiencing deterioration and disrepair. 97 this is not a new problem. in fact, most of the road and sidewalk issues seen today originated in the 1970s when the city of indianapolis and marion county consolidated. 98 prior to the city————————————————————————————— 92. jill sheridan, no turn on red signs going up in indianapolis, wyfi indianapolis (aug. 10, 2023), https://www.wfyi.org/news/articles/no-turn-on-red-signs-going-up-inindianapolis [https://perma.cc/ja8e-fts4]. 93. matt christy, republican state senator moves to void indy’s no-turn-on-red ordinance, fox 59, https://fox59.com/indianapolitics/republican-state-senator-moves-to-voidindys-no-turn-on-red-ordinance/ [https://perma.cc/n4kt-yu3m] (last updated jan. 4, 2024, 2:40 pm). 94. e-mail from indianapolis city-councilor to constituent (on file with author). 95. brenna cooper, indianapolis infrastructure impacts pedestrian safety, indianapolis recorder (oct. 7, 2021), https://indianapolisrecorder.com/indianapolis-infrastructure-impactspedestrian-safety/ [https://perma.cc/z65v-9f6w]. 96. id. 97. id. 98. id. https://perma.cc/z65v-9f6w https://indianapolisrecorder.com/indianapolis-infrastructure-impacts https://perma.cc/n4kt-yu3m https://fox59.com/indianapolitics/republican-state-senator-moves-to-void https://perma.cc/ja8e-fts4 https://www.wfyi.org/news/articles/no-turn-on-red-signs-going-up-in indiana health law review [vol. 22:155 170 county merger, every indianapolis street had a sidewalk while the county had no set standards. 99 post-merger economic woes led to the city halting new sidewalk construction altogether during the 1990s. 100 this compounded the challenges faced by pedestrians, particularly those reliant on walking as their primary mode of transportation. 101 despite boasting a vast road network spanning 3,400 miles (or 8,400 miles if each lane is counted), indianapolis has a serious issue—more than half of these roads, primarily residential streets, are without sidewalks. 102 nearly 2,000 miles of roads in the city have no sidewalks at all, rendering them hazardous and inconvenient for pedestrians. 103 the financial burden of installing sidewalks on all the roads in indianapolis is far beyond the city’s budget and capacity. 104 in 2022, the city contracted the infrastructure firm hntb corporation to conduct a study examining the cost of fixing all of the city’s transportation-related infrastructure, including sidewalks, culverts, traffic signals, and bridges. 105 the study estimated that it would take $7.2 billion to build missing sidewalks, with an additional $92 million needed to rectify the poor condition of existing sidewalks. 106 for context, the city’s proposed total budget for 2024 slightly exceeds $1.5 billion, with only a fraction of that ($325.7 million) allocated for transportation infrastructure. 107 furthermore, a mere $6.3 million is expected to go towards pedestrian safety improvements. 108 this fiscal reality means that city leaders must make tough choices and prioritize other projects and solutions over addressing the sidewalk deficiency. while it is easy to attribute indianapolis's sidewalk shortage solely to financial constraints, a deeper investigation reveals the issue's roots in historical and systemic discrimination. these roots are exemplified in a july 2022 incident reviewed by the indianapolis fatal crash review commission, where a pedestrian fatality on dr. mlk jr. drive highlighted the ongoing consequences of interstate highways on local connectivity. 109 such highways, legacies of discriminatory urban planning, have fragmented communities and led to ————————————————————————————— 99. id. 100. id. 101. indygo, supra note 43. 102. kayla dwyer, indianapolis should spend 5 times what it currently does on infrastructure, study says, indystar (mar. 16, 2022, 5:01 am), https://www.indystar.com/story/ news/local/transportation/2022/03/16/indianapolis-infrastructure-billion-dollar-gap-roadsbridges-sidewalks/7006898001/ [https://perma.cc/eqx4-33eg]. 103. id. 104. id. 105. id. 106. id. 107. city of indianapolis, 2024 proposed budget book 7–8 (2023). 108. id. at 8. 109. indianapolis fatal crash review comm’n, supra note 84. https://perma.cc/eqx4-33eg https://www.indystar.com/story 2025] the road to safer streets 171 underinvestment in pedestrian infrastructure. 110 andrew w. ramsey, a local civil rights activist and educator, wrote about this issue in the indianapolis recorder in 1970, deconstructing the adverse impacts of these "concrete ribbons." 111 his critique highlighted how interstate highways, particularly in indianapolis, carved "island towns" within the city, cutting through neighborhoods and severing essential connections to city services. 112 this urban dissection left a scar on the community, leading to isolation, heightened insurance rates, and plummeting property values. 113 figure 7: map of the 2022 fatal pedestrian collision site114 ————————————————————————————— 110. fact sheet: equity in the bipartisan infrastructure law, u.s. dep’t of transp., https://www.transportation.gov/bipartisan-infrastructure-law/fact-sheet-equity-bipartisaninfrastructure-law [https://perma.cc/m2sq-8zpx] (last updated jul. 5, 2022). 111. andrew w. ramsey, denizens of island black ghettos get the official 'if', indianapolis recorder, june 27, 1970, at 9. 112. id. 113. id. 114. indianapolis fatal crash review comm’n, supra note 84. https://perma.cc/m2sq-8zpx https://www.transportation.gov/bipartisan-infrastructure-law/fact-sheet-equity-bipartisan indiana health law review [vol. 22:155 172 figure 7 showcases an example of the aftermath of such planning in the area surrounding the fatal collision on dr. mlk jr. drive. this neighborhood, once a hub of local activity and connectivity, has been disrupted since the early 1970s.115 during their daily commutes, pedestrians are met with perilous conditions as they navigate unmarked crossings at 33rd or 32nd street to find continuity in their sidewalks. 116 the allocation of infrastructure funding has historically favored commuters and car owners, often at the expense of pedestrian safety and mobility in historically disadvantaged communities. 117 with over 30,000 marion county households living without a vehicle and relying on these inadequate sidewalks, 118 the recent pedestrian fatality on dr. mlk jr. drive serves as an important reminder of the need to address long-standing inequities resulting from past infrastructural decisions. 3. lighting infrastructure inadequacies in indianapolis transitioning from the pressing issue of sidewalks, the spotlight now shifts to another critical aspect of pedestrian safety—lighting infrastructure inadequacies in indianapolis. while strides have been made through initiatives like "operation night light," indianapolis is still far behind other comparably sized cities in terms of street lighting. 119 exploring the deficiencies in lighting infrastructure reveals an additional layer to the challenges pedestrians face. in 1980, indianapolis city leaders, when faced with a staggering $2.9 million annual electric bill, instituted a moratorium on new street light installations. 120 for the next thirty-five years, the city remained in the dark, until mayor joe hogsett initiated “operation night light” in 2015. 121 the initiative aimed to install up to 4,000 new streetlights in indianapolis. 122 despite these efforts, indianapolis still trails behind comparable cities in terms of street lighting. by 2025, the initiative is expected to increase the total number of lights in the city to 33,000, 123 which will still be significantly lower than other comparably sized cities such as minneapolis (48,000) and milwaukee (77,000), according to an ————————————————————————————— 115. id. 116. id. 117. u.s. dep’t of transp., supra note 111. 118. dauphinais, supra note 53. 119. operation night light, indy.gov, https://www.indy.gov/activity/operation-nightlight [https://perma.cc/a979-bbgc] (last visited oct. 12, 2023). 120. john tuohy & tony cook, left in the dark: indy’s deadly streets, indystar, https:// www.indystar.com/story/news/2016/09/18/left-dark-indys-deadly-streets/88838610/ [https:// perma.cc/lr9t-cmjx] (last updated sept. 19, 2016, 7:44 am). 121. indy.gov, supra note 119. 122. id. 123. amelia pak-harvey, indianapolis has installed hundreds of new streetlights, indystar, https://www.indystar.com/story/news/local/marion-county/2020/03/18/indianapolis-hasinstalled-hundreds-streetlights/4798738002/ [https://perma.cc/zhz6-bwj8] (last updated mar. 21, 2020, 8:38 pm). https://perma.cc/zhz6-bwj8 https://www.indystar.com/story/news/local/marion-county/2020/03/18/indianapolis-has https://indy.gov https://www.indystar.com/story/news/2016/09/18/left-dark-indys-deadly-streets/88838610 https://perma.cc/a979-bbgc https://www.indy.gov/activity/operation-nightlight https://indy.gov 2025] the road to safer streets 173 indystar analysis.124 figure 8: % of indianapolis pedestrian crashes in the dark125 2016 100% 2017 83% 2018 91% 2019 94% 2020 84% 2021 89% figure 8 sheds light on the inadequate street lighting in indianapolis, revealing that the percentage of pedestrian crashes in the dark remained consistently high from 2016 to 2021, ranging from 83% to 100%. this data suggests that the ongoing addition of only 4,000 streetlights through operation night light has not markedly improved pedestrian safety. furthermore, the data indicates a worsening situation over time. between 2010 and 2016, the average percentage of incidents occurring in dark conditions was 78%. however, from 2016 to 2021, the average rose to 90%, underscoring the urgent need for increased and enhanced lighting in the city reflective of its growing population and size. 126 the 10% drop between 2019 and 2020 is most likely attributable to fewer cars on the road during covid-19 lockdowns, resulting in fewer pedestrian deaths at night. the shortcomings in street lighting in indianapolis not only underscore immediate safety concerns, but also pave the way for a deeper exploration of policy-driven challenges that hinder progress in safeguarding pedestrians and cyclists. e. policy-driven challenges at the state level in indiana 1. inequitable road funding formulas at the state level, a central challenge stems from the imbalanced distribution of road funding. gas tax revenues, intended for road maintenance and improvements, are allocated based on the number of center lane miles without considering road width, usage, or an urban-rural classification. 127 consider a ————————————————————————————— 124. tuohy & cook, supra note 120. 125. health by design, marion county pedestrian crash data report 8 (2022). this graph was created by the author using the statistics provided in the cited article. 126. id. at 2, 8 (averages calculated by taking the mean of the percentages reflected in the chart on page 8 of the report). 127. transportation funding flowchart (illustration), ind. dep’t of transp. (2003), https://www.researchgate.net/profile/qiang-bai-3/publication/254638489/figure/fig1/as:66949 6935202819@1536631916134/ndiana-transportation-funding-chart-indot-2003.png [https:// perma.cc/8yua-52fn]. https://www.researchgate.net/profile/qiang-bai-3/publication/254638489/figure/fig1/as:66949 indiana health law review [vol. 22:155 174 scarcely used two-lane rural road serving family farms in a remote area of indiana. contrast this with washington street in indianapolis, a bustling fourlane urban thoroughfare complete with crosswalks, traffic lights, sidewalks on both sides, and a high volume of vehicle traffic contributing to rapid road wear. despite the differences in usage and maintenance needs, the funding formula treats these roads as identical, focusing solely on their length. 128 indianapolis city-county councilor, dan boots, analyzed the funding disparities, finding that “indianapolis gets about $3.22 per vehicle mile traveled (vmt) of the total statewide distribution, while the smallest county in indiana . . . receives $19.15.”129 this funding strategy is inequitable, unsustainable, and fails to address the varied demands and maintenance requirements of diverse road types. furthermore, with over 180,000 individuals commuting to work in marion county but residing elsewhere, the city lacks an effective means to tax these individuals who contribute to the daily wear and tear on indianapolis’ roads. 130 this leads to an inequitable situation where commuters benefit from city's job opportunities, amenities, and infrastructure, yet pay their income taxes to neighboring counties that already enjoy superior infrastructure. meanwhile, marion county residents are left shouldering the financial burden and crumbling infrastructure. in the face of this, the state should reconsider how road funding is dispersed, incorporating additional metrics beyond center line miles to ensure proper upkeep and fair distribution. 2. lack of statutory protections for pedestrians indiana's legal framework offers limited safeguards for pedestrians, both in the civil and criminal courts, perpetuating an environment where accountability for collisions is hard to come by. for example, crossing streets outside designated areas requires pedestrians to yield the right-of-way to all vehicles on the roadway.131 further, indiana law holds children as young as twelve responsible for contributory negligence in pedestrian accidents, illustrated in the case of dale smith, where a twelve-year-old was struck while crossing a road in kokomo.132 smith, crossing a four-lane road with no sidewalks, crosswalks, or stop signs to get milk for his family, was deemed negligent by the court of appeals for not seeing the incoming vehicle and was, therefore, unable to recover ————————————————————————————— 128. id. 129. dan boots, why indianapolis roads don’t ever seem to get better, n. shadeland alliance (feb. 8, 2023), https://northshadeland.com/why-indianapolis-roads-dont-ever-seemto-get-better/ [https://perma.cc/bh5n-3d96]. 130. indiana commuting patterns (illustration), hoosiers by the numbers (june 2023), https://www.hoosierdata.in.gov/infographics/commuting-acs.asp [https://perma.cc/vea5anck]. 131. ind. code § 9-21-17-7 (2024). 132. smith v. diamond, 421 n.e.2d 1172, 1180 (ind. ct. app. 1981). https://perma.cc/vea5 https://www.hoosierdata.in.gov/infographics/commuting-acs.asp https://perma.cc/bh5n-3d96 https://northshadeland.com/why-indianapolis-roads-dont-ever-seem 2025] the road to safer streets 175 damages after a driver hit him. 133 given the infrastructural shortfalls in indianapolis, such as the lack of proper crosswalks, sidewalks, and lighting, cases like this create a presumption that children are guilty when accidents occur. in smith’s case, the court debated whether he could have even seen the vehicle due to a car blocking his view, yet he was still held responsible. 134 similarly, esther jones, who was struck by a car on a rainy night in indianapolis while crossing the street, was found negligent by the indiana supreme court due to being outside a crosswalk, even though her testimony, and that of another witness, revealed that the driver did not have headlights on.135 the driver’s simple denial was enough to convince the majority of the court that jones was to blame, resulting in her receiving no recovery on her claim. 136 justice debruler dissented, questioning how the testimony of two witnesses could be so easily dismissed by one person’s claim that he had his headlights on.137 this case reflects a troubling pattern: the courts' willingness to dismiss pedestrian testimony in favor of drivers, even when evidence suggests the driver's negligence. guidance for pedestrians walking on streets lacking sidewalks or shoulders is outlined by statute, directing them to walk near the roadway's edge. 138 if the road is two-way, they must walk on the left side of the road. 139 however, legal complexities arise, as seen in hill v. gephart, where a pedestrian's violation of this statute led to a severe collision. 140 in this case, hill and his daughter walked to a park near their home. 141 on their way back, near dusk, they walked on the side of the street with their backs to traffic. 142 the street had no sidewalks. 143 hill was hit by a jail transport vehicle that was driving 10 mph over the speed limit and suffered numerous severe injuries that left him incapacitated. 144 an accident reconstruction specialist concluded that the cause of the accident was the dusk environment and the dark clothes hill wore. 145 although the trial court granted summary judgment in favor of the driver, the court of appeals reversed, finding that hill should be allowed to argue why he was walking on the right side of the road, where vegetation blocked the left side. 146 the court held that a jury should decide whether his decision was reasonable under the ————————————————————————————— 133. id. at 1173. 134. id. at 1179–80. 135. jones v. gleim, 468 n.e.2d 205, 208 (ind. 1984). 136. id. at 207. 137. id. at 208 (debruler, j., dissenting). 138. ind. code § 9-21-17-14 (2024). 139. id. 140. 54 n.e.3d 402, 407 (ind. ct. app. 2016), aff’d on reh’g, 62 n.e.3d 408 (ind. ct. app. 2016). 141. id. at 404. 142. id. 143. id. at 404 n.1. 144. id. at 404–05. 145. id. at 405 146. id. at 407. indiana health law review [vol. 22:155 176 circumstances, rather than barring his claim outright. these examples underscore the difficulties pedestrians face in navigating roads without proper infrastructure and highlight the judicial leniency often afforded to drivers. even though hill was struck by a speeding driver on a road without sidewalks, the trial court initially granted summary judgment against him. 147 only on appeal was he given the opportunity to justify his decision to a jury. 148 the broader concern is that if pedestrians are consistently held to unreasonable standards in a city with no traffic law enforcement and skyrocketing rates of accidents, they will never succeed in court. one could argue that it is not the driver’s fault if a street has improper infrastructure or crosswalks, but that raises the issue of accountability. if not the driver, then responsibility must fall on the city, the police, or the state, because multiple failures allowed such accidents to occur in the first place. the state’s stance on criminal charges further complicates the pursuit of justice for pedestrians and cyclists. in indiana, when a driver crashes into a vulnerable road user causing harm or death, the driver’s actions are not necessarily considered to be criminal. 149 it only ascends to criminality if accompanied by additional illegal conduct, such as impaired driving150 or hitand-run behavior. 151 for the driver’s actions to be considered criminal, the act of crashing into the vulnerable road user must be linked to illicit behavior such as driving under the influence152 or fleeing the scene after the crash. 153 in the instances where drivers face criminal charges for causing a fatality, the penalties can be surprisingly lenient—often no more severe than a temporary license suspension or a small fine, which scarcely reflects the serious nature of taking a life.154 this leniency is illustrated in a july 2022 case documented by the indianapolis fatal crash review commission. 155 in this collision, a cyclist was struck from behind by a motorist with eighteen prior offenses. 156 remarkably, the incident's potential criminality hinged not on the act of causing death but on the driver's failed attempt to flee the scene. under indiana’s existing legal framework, had the driver not tried to evade, they likely would have faced minimal consequences. it is troubling that someone with 18 prior offenses can continue driving and ultimately cause a fatality. complicating matters further, indiana lacks a "negligent vehicular homicide" law, a gap acknowledged in whitaker v. state, where the court noted ————————————————————————————— 147. id. at 404. 148. id. at 407. 149. ind. code § 9-30-16-2 (2024). 150. ind. code § 9-30-5-5 (2024). 151. ind. code § 9-26-1-1.1 (2024). 152. ind. code § 9-30-5-5 (2024). 153. ind. code § 9-26-1-1.1 (2024). 154. ind. code § 9-30-16-2 (2024). 155. indianapolis fatal crash review comm’n, supra note 84 at 7. 156. id. 2025] the road to safer streets 177 that the general assembly has not enacted statutes for “negligent homicide” or “vehicular homicide,” unlike in other states. 157 such a statute would address deaths caused by careless, yet not intentionally reckless, driving. currently, establishing accountability in fatal traffic accidents demands proof of reckless disregard for safety. 158 in other words, a driver must knowingly take substantial risks that endanger lives to be held accountable. 159 the high burden of proof is exemplified in cozmanoff v. state, where the defendant received a four-year sentence for reckless homicide after fleeing a scene where he hit four correctional officers, resulting in one death. 160 the cozmanoff case demonstrates how the absence of a negligent vehicular homicide statute allows for a significant gap in accountability. while cozmanoff’s actions were extreme enough to meet the threshold for reckless disregard, many cases involving fatal traffic accidents do not rise to this level. without a statute addressing negligent driving, drivers who cause deaths through careless actions—such as speeding or distracted driving—can evade criminal liability. this leaves victims’ families with little recourse and perpetuates a legal framework that fails to adequately address the seriousness of negligent driving in fatal accidents. in indiana, one final law stands out for its inadequacy in safeguarding pedestrians and cyclists. the state’s safe passing statute mandates a minimum three-foot clearance for vehicles overtaking bicycles. 161 however, this statute fails to offer any mandates for drivers overtaking pedestrians walking on roads. in the city of indianapolis, where over half the city roads (2,000 miles) do not have sidewalks, pedestrians often have no choice but to walk on and alongside roads. 162 additionally, the statute explicitly allows drivers to pass cyclists in nopassing zones when it is "safe to do so," which appears to contradict the very purpose of no-passing zones. 163 roads are marked with double lines due to unclear sightlines or the lack of a safe opportunity to pass. by allowing exceptions to these markings, the law promotes risky behavior, encouraging drivers to attempt unsafe maneuvers that put themselves, oncoming drivers, and cyclists at unnecessary risk. the absence of a mandated safe passing distance for pedestrians, coupled with their obligation to yield to vehicles on the roadway, highlights the extent to which pedestrian safety is marginalized in favor of motorists.164 indiana's legal protections for pedestrians and cyclists are alarmingly inadequate, casting a shadow over the state's commitment to public safety. in ————————————————————————————— 157. whitaker v. state, 778 n.e.2d 423, 425 (ind. ct. app. 2002). 158. id. (noting the absence of statutes for negligent or vehicular homicide in indiana, which would address deaths caused by less than reckless conduct). 159. id. (explaining that accountability for fatal traffic accidents in indiana requires proof of reckless disregard, rather than mere negligence). 160. cozmanoff v. state, 134 n.e.3d 513, 514 (ind. ct. app. 2019). 161. ind. code § 9-21-8-5(3)(a) (2024). 162. dwyer, supra note 102. 163. ind. code § 9-21-8-5(4) (2024). 164. ind. code § 9-21-17-7 (2024). indiana health law review [vol. 22:155 178 civil matters, victims face barriers impacting their ability to secure compensation for injuries. in criminal matters, drivers are not held accountable; in 2020 and 2021, a staggering 78% of fatal crashes involving vulnerable road users went without criminal charges. 165 the report of a driver with eighteen prior offenses fatally striking a cyclist underscores a broader issue: a tolerance for repeat offenders until it's too late. with the legal shortcomings now acknowledged, the following section proposes preventative measures to ensure crashes are avoided before they occur. iii. analysis a. combatting traffic law enforcement inadequacies even those who may not initially grasp the severity of the pedestrian and cyclist safety crisis cannot ignore the compelling evidence it presents. data reveals a troubling reality: half of all incidents involving pedestrians and cyclists are concentrated in just 7% of the city’s land area;166 areas often inhabited by vulnerable groups such as people of color and the elderly. 167 this crisis is exacerbated by a no-traffic law enforcement. yet, proposing an increase in police patrols in the most affected neighborhoods introduces potential risks, including discriminatory enforcement and harassment, particularly towards marginalized communities. for example, in carmel, indiana, statistics show that black individuals are ticketed at a rate eighteen times higher than their representation in the local population. 168 while indianapolis exhibits less racial bias in ticketing, with black residents receiving about 40% of tickets despite making up 30% of the population, it still raises questions about fairness and equity in law enforcement practices. 169 accordingly, while increased traffic enforcement might reduce the risk of traffic-related danger, it may simultaneously increase the risk of the harms associated with racial profiling, harassment, and violence at the hands of law enforcement. a better alternative to increased police presence can be found with the implementation of speed cameras, which offer a promising solution with a track record of successfully reducing speeding and accidents across the country. indiana legislators saw the value in this technology as a means to bolster road ————————————————————————————— 165. dwyer, supra note 11. 166. kayla dwyer, indianapolis’ fatal crash problem is worsening. here are 4 takeaways and what’s to be done, indystar, https://www.indystar.com/in-depth/news/local/transportation/ 2022/05/02/accident-takeaways-indianapolis-traffic-fatal-car-crashes-pedestrian-safety-crisisviable-answers/7268573001/ [https://perma.cc/zk4a-w6kr] (last updated may 2, 2022. 1:50 pm). 167. id. 168. stephanie zepelin, carmel police ticket black drivers at higher rate, data shows, wishtv, https://www.wishtv.com/news/i-team-8/carmel-police-ticket-black-drivers-at-higherrate-data-shows/ [https://perma.cc/nk2d-2hhl] (last updated jun. 24, 2020, 11:35 am). 169. id. https://perma.cc/nk2d-2hhl https://www.wishtv.com/news/i-team-8/carmel-police-ticket-black-drivers-at-higher https://perma.cc/zk4a-w6kr https://www.indystar.com/in-depth/news/local/transportation 2025] the road to safer streets 179 safety for pedestrians after investigating how to combat the noticeable uptick in work zone fatalities and injuries observed from 2019 to 2022. 170 however, the deployment of speed cameras in indiana has been cautiously approached by the state legislature, resulting in the implementation of a limited pilot program confined to highway work zones.171 this program is tightly regulated, allowing only four speed cameras statewide and mandating extensive advance notice to drivers, reflecting legislative concerns about privacy and the potential for increased surveillance. 172 in addressing privacy concerns associated with the widespread implementation of speed cameras across indiana, the necessity for precise and transparent legislation cannot be overstated. such legislation must guarantee that data captured by speed cameras is restricted in scope, securely safeguarded, and quickly deleted after its intended use for public safety. 173 this approach helps protect people's privacy while also keeping roads safe. 174 another factor to consider is that the emphasis on privacy concerns in discussions surrounding speed camera legislation may not be entirely rooted in privacy advocacy. considering the extensive surveillance networks already established in indianapolis and other cities within indiana, the opposition to only speed cameras is surprising. remarkably, the city of indianapolis administers a comprehensive surveillance system, comprised of over 300 license plate readers that monitor the movements of thousands of vehicles every minute, a practice that has been in place for the better part of a decade.175 katie blair of the aclu of indiana has articulated apprehensions regarding the potential of such pervasive surveillance to empower oppression, effectively casting all community members as subjects of suspicion. 176 while the extensive data collection by these readers undeniably raises legitimate privacy concerns, speed cameras emerge as a narrowly tailored solution. their aim is straightforward: to enforce speed limits for the sake of public safety, without engaging in the broader, more ————————————————————————————— 170. casey smith, indiana senate advances license plate speed camera pilot despite republican pushback, ind. cap. chron. (apr. 4, 2023, 6:00 am), https://indianacapital chronicle.com/2023/04/04/speed-camera-pilot-bill-advances/ [https://perma.cc/z92t-mb2v]. 171. ind. code § 8-23-32-11 (2024). see also h.b. 1015, 122d gen. assemb., 1st reg. sess. (ind. 2023). 172. smith, supra note 170. 173. steve scauzillo, controversial bill to put ‘speed cameras’ on la streets has backers in sacramento, l.a. daily news, https://www.dailynews.com/2023/04/21/controversial-bill-toput-speed-cameras-on-la-streets-has-backers-in-sacramento/ [https://perma.cc/xuh6-blpm] (last updated oct. 16, 2023, 3:36 pm). 174. id. 175. vic ryckaert, license plate readers are solving crimes but critics fear misuse, privacy concerns, wrtv, https://www.wrtv.com/news/local-news/crime/license-plate-readersare-solving-crimes-but-critics-fear-misuse-privacy-concerns#:~:text=they%20snap%20pictures %20of%20thousands,%2c%20muncie%2c%20anderson%20and%20plainfield [https://perma. cc/vsu3-pnaz] (last updated july 25, 2023, 1:20 pm). 176. id. https://perma https://www.wrtv.com/news/local-news/crime/license-plate-readers https://perma.cc/xuh6-blpm https://www.dailynews.com/2023/04/21/controversial-bill-to https://perma.cc/z92t-mb2v https://chronicle.com/2023/04/04/speed-camera-pilot-bill-advances https://indianacapital indiana health law review [vol. 22:155 180 intrusive surveillance practices associated with license plate readers. unlike the current readers, speed cameras do not track the comprehensive movements of drivers across the city, state, and country, nor do they share or retain data indefinitely.177 examining success stories from other states offers a compelling argument for indiana to expand the adoption of speed cameras. pennsylvania’s automated work zone speed enforcement program, one of the first in the nation, has achieved remarkable results in curbing excessive speeding and reducing work zone crashes with only 2.6% of drivers exceeding the speed limit by more than 11 mph in work zones equipped with speed cameras. moreover, work zone crashes decreased for pennsylvania in 2022, while the national average has increased. 178 new york’s experience with speed cameras since 2013, particularly around school zones where children are vulnerable to speeding drivers, further strengthens the case for this technology. a pilot program with 20 speed cameras operating during school hours showed dramatic decreases in speeding violations (63%), injuries (17%), and fatalities (55%) in the selected school zones. the program has since expanded to be the largest urban network of safety cameras in the u.s., with 2,000 cameras in operation. 179 given the proven effectiveness of speed cameras, indiana lawmakers must permit the usage of speed cameras beyond work zones. these devices, being cost-effective and evidence-based, can significantly enhance safety in pedestrian and cyclist high-risk areas. furthermore, speed cameras mitigate the risk of officer discretion in ticket issuance, resulting in more equitable enforcement of traffic laws. beyond speed cameras, it is essential for the city to tackle the infrastructural shortfalls that initially place pedestrians and cyclists in harm's way, paving the way for a comprehensive strategy to enhance urban safety. b. improving infrastructure indianapolis leaders are at a crossroads, grappling with a dire need for infrastructure improvements while facing severe financial constraints. transforming and pedestrianizing all 3,000 miles of marion county's roads is a logistical impossibility. 180 hindered by the inability to levy sales taxes, capped property taxes, and the improbability of instituting new levies like a commuter tax, indianapolis finds its hands tied, pushing the city into an overreliance on ————————————————————————————— 177. id. 178. pa. dep’t of transp., 2023 annual report automated work zone speed enforcement 2 (2023). 179. u.s. dep’t of transp. fed. highway admin., successful strategies for adoption of safety cameras 2 (2020), https://safety.fhwa.dot.gov/speedmgt/ref_mats/fhwasa200 76/fhwa-sa-20-081-successful_strategies_for_adoption_of_safety_cameras.pdf [https:// perma.cc/525f-4h7f]. 180. dwyer, supra note 102. https://safety.fhwa.dot.gov/speedmgt/ref_mats/fhwasa200 2025] the road to safer streets 181 federal funds to bridge the gap in its infrastructure budget. 181 this is not a good position for pedestrians and cyclists to be in, given the slow and competitive nature of federal funding allocations. the city's receipt of $25 million from the bipartisan infrastructure law of 2021—matched with an additional $20 million of indianapolis’s own funding— marks a step forward, yet this $50 million investment will only slightly dent the city's vast needs, covering a mere 3.5 miles of sidewalk improvements and 5.5 miles of resurfaced bike lanes. 182 with construction bids not anticipated until 2026 and completion a year later, the pace of progress is alarmingly out of sync with the immediacy of the crisis. 183 indianapolis's struggle for more comprehensive federal support was evident when its application for the safe streets and roads for all (ss4a) grant program was turned down in 2023. 184 this cycle of dependency on uncertain federal support underscores the city's vulnerability to shifting political winds and policy priorities, emphasizing the inadequacy of piecemeal funding in tackling widespread infrastructure deficits. 185 amid these challenges, addressing the inequitable gas tax formulas could be a potential avenue to unlock additional funding for indianapolis. city leaders recently put forth two proposals for the state legislature that, if adopted, could dramatically increase urban infrastructure funding. 186 the first proposal seeks to shift the basis for allocating state funds from center line miles—a method that doesn’t account for traffic volume or road usage intensity—to a system based on total vehicle miles traveled (vmt). this change would ensure that roads with higher traffic volumes, typically found in urban areas like indianapolis, receive a fairer share of funding. 187 although the proposal to base funding on vmt would better reflect the infrastructure demands of urban areas, it is likely to face resistance. given the state's historical interference in indianapolis' affairs, particularly to the city’s disadvantage, it remains uncertain whether such a change will be promptly adopted. nevertheless, discussions on reforming the funding formula to account ————————————————————————————— 181. id. 182. indianapolis to spend $46.5m on road improvements. here's what the city plans, indystar, https://www.indystar.com/story/news/local/indianapolis/2023/06/29/indianapolisroad-improvements-bipartisan-infrastructure-law-grant/70370273007/ [https://perma.cc/q2zp78gv] (last updated june 29, 2023, 4:52 pm). 183. id. 184. kaitlyn kendall, indianapolis denied federal money by biden administration to make roads physically safer, wrtv, https://www.wrtv.com/news/state-news/indiana-denied-federalmoney-by-biden-administration-to-make-roads-physically-safer [https://perma.cc/3e9z-2hsq] (last updated feb. 23, 2023, 9:18 pm). 185. dwyer, supra note 102. 186. ko lyn cheang, hogsett to put $30m into residential streets and press state for fair funding formula, indystar, https://www.indystar.com/story/news/local/indianapolis/2023/07/ 06/indianapolis-roads-joe-hogsett-to-spend-30-million-wants-fair-state-funding-formula/70388 030007/ [https://perma.cc/yx82-xq4s] (last updated july 6, 2023, 4:19 pm). 187. id. https://perma.cc/yx82-xq4s https://www.indystar.com/story/news/local/indianapolis/2023/07 https://perma.cc/3e9z-2hsq https://www.wrtv.com/news/state-news/indiana-denied-federal https://perma.cc/q2zp https://www.indystar.com/story/news/local/indianapolis/2023/06/29/indianapolis indiana health law review [vol. 22:155 182 for traffic volumes are critical. additionally, factoring in pedestrian and cyclist traffic could help further address the reality that cars are not the sole users of roads in urban environments. the second proposal focuses on the community crossing grant program, a source of funding the state holds for local road projects, currently endowed with over $221 million. 188 city leaders are advocating to merge this program with the motor vehicle highway account and, crucially, to eliminate the existing $1 million cap on grants. 189 this cap disproportionately affects larger cities which face more substantial infrastructure challenges and costs, while inadvertently favoring smaller, rural communities with lesser needs. by lifting the cap and rewriting the road funding formulas, indianapolis could gain access to an additional $49 million a year, facilitating significant improvements in road safety and maintenance. this $49 million could provide critical resources for the city’s recently established vision zero task force. 190 announced as part of a broader effort to eliminate traffic deaths and serious injuries by 2035, vision zero currently lacks meaningful funding, which undermines its potential impact. as it stands, the task force risks becoming yet another symbolic initiative without the power to resolve the pedestrian and cyclist safety crisis. however, with proper funding— whether from state grants, reallocating current city resources, or securing additional federal support—the vision zero initiative could be positioned for real success. for that to happen, city leaders must move beyond promises and commit to real, sustained action. cincinnati offers a clear example of how proper investment can lead to meaningful results. after traffic deaths in the city peaked in 2018, cincinnati increased its spending for pedestrian-focused engineering projects from $500,000 to $7 million annually. 191 as a result, the city has seen real progress in reducing traffic fatalities. 192 city councilor mark jeffries noted that more community members are noticing the visible impact of traffic-calming measures now that significant investment and enforcement have been in place for the past two years—something indianapolis has yet to catch onto.193 indianapolis’ vision zero task force could follow a similar path, but only if city leaders take decisive action to allocate proper resources. the next section turns to the state level, where legislative resistance frequently undermines efforts to protect pedestrians and cyclists, stalling crucial ————————————————————————————— 188. id. 189. id. 190. indianapolis, ind., city-county council, gen. ord. no. 224 (2024). 191. andrew rowan, cincinnati has made meaningful progress on pedestrian safety, but still working toward ‘vision zero’, wcpo cin., https://www.wcpo.com/news/localnews/finding-solutions/cincinnati-has-made-meaningful-progress-on-pedestrian-safety-but-stillworking-toward-vision-zero [https://perma.cc/pg3k-hfdj] (last updated jan. 18, 2024, 8:58 pm). 192. id. 193. id. https://perma.cc/pg3k-hfdj https://www.wcpo.com/news/local 2025] the road to safer streets 183 projects like the blue line that are vital for creating safer and more accessible streets. c. legislative hurdles another piece of a comprehensive solution to the crisis could come in the form of a venerable road user law (vru). a vru law would define who are considered vulnerable road users, such as people who walk, bike, use wheelchairs, operate farm equipment, work along streets and highways, operate tow trucks, or are first responders. 194 a vru law would also enhance the civil and criminal liability of drivers who cause harm to vrus, by suspending or revoking licenses, imposing higher fines or fees, requiring driver education or community service, or increasing jail time for drivers who “commit a moving traffic offense that results in serious bodily injury or death of a vulnerable road user.” 195 analogous to the higher penalties in construction work zones, vru laws acknowledge that the same kind of careless driving or traffic offenses that may cause minor crashes between cars can have much worse consequences when a vulnerable road user is involved, allowing there to be clear criminal ramifications for the disparity of the outcomes. 196 unfortunately, proposals for vru laws in indiana face significant opposition from state legislators who are more concerned about protecting driver rights and driver convenience than saving lives. 197 this reluctance to implement protections for vulnerable groups underscores a misconceived notion of a “war on cars,” while failing to recognize that enhancing safety for one group benefits all road users, including drivers. 198 in tandem with a vru law, revisiting indiana’s safe passing law could provide additional protections for pedestrians and cyclists. 199 for example, new hampshire’s safe passing law sets a higher standard by creating a due care responsibility for drivers passing cyclists, defining a reasonable and prudent distance based on road conditions, and requiring greater distances when speed and road conditions demand it.200 indiana’s current law, by contrast, provides only a rigid three-foot buffer, without consideration for varying speeds or road conditions, and lacks many of the additional protections seen in other states. 201 ————————————————————————————— 194. s.b. 211, 123rd gen. assemb., 1st reg. sess. (ind. 2023). 195. id. 196. ken mcleod, bike law university: vulnerable road user laws, league of am. bicyclists (mar. 28, 2013), https://bikeleague.org/bike-law-university-vulnerable-road-userlaws/ [https://perma.cc/jb6e-dxer]. 197. ko lyn cheang, in bid to protect pedestrians, indy defies state lawmaker to push no-turn-on-red proposal, indystar, https://www.indystar.com/story/news/local/indianapolis/ 2023/06/02/indianapolis-no-turn-on-red-city-county-council-defies-legislature/70278284007/ [https://perma.cc/5l9c-pcr4] (last updated june 2, 2023, 9:46 am). 198. id. 199. see ind. code § 9-21-8-5 (2024). 200. n.h. rev. stat. ann. § 265:143-a (2024). 201. ind. code § 9-21-8-5 (2024). https://perma.cc/5l9c-pcr4 https://www.indystar.com/story/news/local/indianapolis https://perma.cc/jb6e-dxer https://bikeleague.org/bike-law-university-vulnerable-road-user indiana health law review [vol. 22:155 184 to improve safety, indiana’s law should define specific guidelines for safely passing pedestrians walking on streets without sidewalks, as these individuals are particularly vulnerable. furthermore, the statute’s provision allowing drivers to pass bicycles in no-passing zones “when it is safe to do so” 202 should be eliminated. this exception contradicts the very purpose of no-passing zones, especially when vulnerable road users are involved. instead of setting a fixed passing distance, indiana could follow new hampshire’s model by instituting a general duty of care. this would allow for a more adaptable approach, ensuring that drivers maintain a safe distance based on the specific conditions of the road. finally, the state must refrain from interfering in city affairs and obstructing vital safety projects, as seen with their failed attempts to block both the no-turnon-red ordinance and the blue line expansion. these critical initiatives, aimed at improving pedestrian safety, should not face opposition from state legislators more concerned with preserving road miles than protecting vulnerable road users, as this not only jeopardizes federal funding but also puts the entire project at risk of never being realized. 203 pedestrian corridors like washington street, which make up only 0.4% of the city’s road mileage, saw thirty-two fatal crashes between 2015 and 2020, accounting for 6% of the county’s total fatal crashes during that period. 204 the planned rework of washington street, utilizing federal funding for the blue line expansion, is a clear example of significant progress at risk due to state interference. these obstructions must be actively opposed by advocates, city officials, and the community to ensure that critical infrastructure improvements, policy changes like the vru law, and safety measures are not blocked by legislative resistance. iv. conclusion the tragic story of henry najdeski and the subsequent deaths highlighted in this note underscore the tragedy of pedestrian and cyclist safety in indiana. these deaths and many others across the city, state, and nation are not merely accidents. they are the result of systemic failures—failures to prioritize safety, enforce accountability, and address the racial and infrastructural divides that persist today. as of september 2024, indianapolis is on pace to experience its third consecutive record-breaking year for pedestrian and cyclist incidents, with 589 reported to date. 205 this is not the time to push blame from one party to ————————————————————————————— 202. id. 203. james briggs, the view from aaron freeman's indianapolis, indystar, https://www. indystar.com/story/opinion/columnists/james-briggs/2024/01/09/aaron-freeman-returns-to-fightindygos-blue-line-right-on-red-ban/72154360007/ [https://perma.cc/bu5u-qujs] (last updated jan. 9, 2024, 6:04 am). 204. dwyer, supra note 11. 205. indy pedestrian safety crisis dashboard, indianapolis pedestrian & bicyclist safety crisis, https://www.indypedcrisis.info/#/dashboard [https://perma.cc/dt8f-wzas] (last visited nov. 21, 2024). https://perma.cc/dt8f-wzas https://www.indypedcrisis.info/#/dashboard https://perma.cc/bu5u-qujs https://indystar.com/story/opinion/columnists/james-briggs/2024/01/09/aaron-freeman-returns-to-fight https://www 2025] the road to safer streets 185 another; it is the time for clear, decisive action. the solutions to this crisis are within reach. from infrastructure upgrades to legislative reforms, the tools necessary to prevent these tragedies are already available. now is the time for clear enforcement, transparent funding, and unwavering commitment from all stakeholders—policymakers, engineers, city planners, and law enforcement. a proactive approach must be adopted, recognizing that safer streets inherently serve the common good, fostering a healthier, more vibrant, and equitable city for all. structure bookmarks he oad to afer treetsackling the edestrian yclist afety risis in ndianapolis with liberty and justice for all: the case for decriminalizing homelessness and mental health in america with liberty and justice for all: the case for decriminalizing homelessness and mental health in america siya hegde and carlton martin * i. introduction i remember the heartbreak i felt when my best friend deserted me shortly after our wedding . . . i spiraled into an even deeper depression, leading to my resignation from apple and eventual homelessness in north carolina. events turned even more harrowing when an unfortunate encounter with the police led to my hospitalization and official diagnoses of psychosis, schizophrenia, and bipolar disorder. all these experiences hammered home the true weight of loneliness. 1 although the study of america’s homelessness epidemic has deepened in the past two decades, 2 public narratives about homelessness are misconceived and inconsistent. when we look beyond the numbers and delve into accounts of advocates like jha’asryel-akquil bishop, whose lived expertise offers a heartbreaking perspective of homelessness, policing, and mental illness, we realize how increased access to voluntary, community-based mental health supports and decriminalization are necessary means to ending homelessness. personal accounts also reinforce how conditions of homelessness are intrinsically intersectional. predominantly black and brown racial and ethnic ————————————————————————————— * siya (she/her) is a civil and human rights lawyer at the national homelessness law center (nhlc), based in new york city, where she is building strategic litigation and policy advocacy capacity in the movement to decriminalize homelessness and make housing a human right. prior, she was a civil public defender and movement lawyer at the bronx defenders, mostly representing clients in eviction proceedings and supporting state and city grassroots tenant groups on housing policy priorities. carlton is the director of the homeless persons representation project’s montgomery and prince george’s county office. carlton leads a team dedicated to providing direct representation to people experiencing homelessness and people who are at risk of homelessness, organizing community-based outreach and educational programs, and advocating for just policies at the local and statewide level. he is a former director at nhlc, where hiswork involved a range of legal and policy issues impacting people experiencing homelessness nationwide. additionally, he was formerly a staff attorney with the indiana supreme court and an indiana deputy state public defender. the authors sincerely thank eric tars (senior policy director, nhlc), tristia bauman (directing attorney of the housing unit, law foundation of silicon valley), and monica porter gilbert (policy & legal advocacy attorney, bazelon center for mental health law) for their constructive editorial support of this writing, as well as the diligent student board of the indiana health law review for this publication opportunity. 1. jha’asryel-akquil bishop, the solitude and power of self-love in overcoming hardships, medium (nov. 3, 2023), https://medium.com/@jhaasryel/the-solitude-and-power-of-self-love-inovercoming-hardships-914bef8cebe1 [perma.cc/3vum-p6q3]. 2. see generally state of homelessness: 2023 edition, nat’l all. to end homelessness (2023), https://endhomelessness.org/homelessness-in-america/homelessness-statistics/state-ofhomelessness/#homelessness-trends-over-time [perma.cc/79lv-m36f] (detailing homelessness trends, noting that homelessness “has largely been defined by steady but modest progress since data collection began in 2007”) [hereinafter state of homelessness]. https://endhomelessness.org/homelessness-in-america/homelessness-statistics/state-of https://medium.com/@jhaasryel/the-solitude-and-power-of-self-love-in indiana health law review [vol. 21:249 250 groups suffer the highest incidences of homelessness and have historically been the most susceptible to land and property exclusion, displacement, eviction, and housing discrimination. 3 gender-based subgroups, such as members of the lgbtqia community, also suffer disproportionately higher rates of unsheltered homelessness and “may not be equally benefitting from government investments in solutions to homelessness.”4 central to each account is the reality that one’s experience of living unsheltered can, and often does, adversely affect their health, safety, and security. living unsheltered can lead to higher rates of chronic disease (i.e., covid-19, tuberculosis, and lung disease) and exacerbate pre-existing serious mental illness. 5 living unsheltered also heightens one’s risk of being physically or sexually victimized, robbed, or otherwise subjected to additional traumas. 6 this article examines the criminalization of people with mental health disabilities who experience homelessness, 7 incorporating various race and poverty factors associating housing with health. section ii critiques the judicial landscape of homelessness criminalization by first turning to the seminal decisions of martin v. boise and johnson v. city of grants pass, which have shaped the past five years of homeless rights law and policy. it then assesses how the insufficient framework of the equal protection clause of the federal constitution limits courts’ abilities to protect the rights of poor people experiencing homelessness and resolve related socioeconomic issues. against this backdrop, section iii details the history of homelessness criminalization, focusing more narrowly on the criminalization of mental health and the emergence of involuntary civil commitments as a proxy of the criminal legal system. the section will address the involuntary mental health directive promulgated in new york city and california’s care act, showcasing the different legal standards governing the commitment processes of people with mental disabilities who experience homelessness in both locations, and the increased role of law enforcement as first responders. our analysis of these ————————————————————————————— 3. see generally richard rothstein, the color of law: a forgotten history of how our government segregated america (2017) (discussing how u.s. governments in the twentieth century systematically imposed racial segregation laws and policies on african americans and other communities of color living in white neighborhoods). 4. state of homelessness, supra note 2. 5. see jessica richards & randall kuhn, unsheltered homelessness and health: a literature review, 2 ajpm focus 1, 6 (2022); see also “about homelessness & health,” cdc off. readiness & response (may 6, 2022), https://www.cdc.gov/orr/science/homelessness/ about.html#:~:text=homelessness%20is%20known%20to%20increase%20the%20risk%20for,i mmunodeficiency%20virus%20%28hiv%29%2c%20and%20coronavirus%20disease%2020 19%20%28covid-19%29 [perma.cc/7c3x-fpxv]. 6. hsun-ta hsu et al., location, location, location: perceptions of safety and security among formerly homeless persons transitioned to permanent supportive housing, 7 j. soc’y soc. work & rsch. 65, 66 (2016). 7. throughout this article, we have chosen to use “people experiencing homelessness” and “people with mental disabilities” in sensitivity to people-first language. this humanizes individuals’ identities and unique needs, rather than suggest that their conditions, statuses, and experiences define their worth and capabilities. https://www.cdc.gov/orr/science/homelessness 2024] with liberty and justice for all 251 involuntary commitment schemes critiques the judicial and policymaking authorities responsible for implementing them. we also incorporate findings from our recent related advocacy before the united nations, emphasizing how such practices that criminalize mental health also violate key civil and political rights—i.e., the right to life—under international law. section iv comments on what “justice” should look like outside the utility of judicial, legislative, and other political bodies when addressing the root causes of homelessness and the criminalization of mental health. our policy recommendations and philosophies draw from a grounding poverty abolitionist framework and set of international human rights principles, with hopes of advancing anti-policing, humane housing solutions across the homelessness decriminalization and eradication movement. section v concludes. ii. legal precedents of the movement to decriminalize homelessness a. martin, johnson, and safeguarding the rights of people experiencing homelessness 2019 marked a pivotal affirmation of federal eighth amendment jurisprudence regarding the rights and protections of people living in encampments. 8 in its seminal opinion of martin v. boise, 9 the ninth circuit held that the eighth amendment’s cruel and unusual punishment clause precludes enforcement of ordinances prohibiting publicly sleeping, sitting, and lying down when an individual had no practical access to shelter. 10 further, it determined that so long as people experiencing homelessness lacked the option of sleeping ————————————————————————————— 8. while martin v. boise (2019) garnered widespread notice for affirming these principles at a time of rapidly accelerating unsheltered homelessness on the west coast, its eighth amendment applications were predated by other cases: robinson v. california, 370 u.s. 660 (1962) (finding that punishing someone for their involuntary status of addiction constituted cruel and unusual punishment under the eighth amendment); powell v. texas, 392 u.s. 514 (1968) (extending the robinson principle to distinguish how convicting an individual for public intoxication did not constitute cruel and unusual punishment under the eighth amendment); pottinger v. city of miami, 810 f.supp. 1551 (s.d.f.l. 1992) (finding that miami’s practice of arresting individuals experiencing homelessness for involuntary, harmless public acts is an eighth amendment violation, a fourteenth amendment violation as per their “fundamental right to travel,” and a fourth amendment violation when their personal property is seized and destroyed in noncompliance with their “own written procedure”); and jones v. city of los angeles, 444 f.3d 1118 (9th cir. 2006) (finding that los angeles could not punish people experiencing homelessness for sleeping on the streets, as doing so would violate the eighth amendment with regard to involuntary conduct). 9. martin v. city of boise, 920 f.3d 584 (9th cir. 2019). 10. the case settled in favor of the six boise residents who were experiencing or recently experienced homelessness, spanning over a decade of litigation, and considered their lack of choice to sleep anywhere but publicly when shelters were at full capacity. indiana health law review [vol. 21:249 252 indoors, the government could not criminalize them “for sleeping outdoors, on public property, on the false premise they had a choice in the matter.”11 while the martin ruling is only binding in the ninth circuit, it has reverberated nationally in other legal battlegrounds. dozens of courts, including federal district courts in pennsylvania, 12 illinois,13 hawai’i, 14 ohio,15 and texas, 16 have cited martin in their opinions. more recently, the ninth circuit reiterated its martin holding and affirmed a district court’s ruling that the city of grants pass, oregon cannot, consistent with the eighth amendment, enforce its anti-camping laws against people experiencing homelessness for the mere act of sleeping outside with rudimentary protection from the elements, or for sleeping in their car at night, when there was no shelter available. 17 the ninth circuit’s ruling in johnson v. city of grants pass, in part, barred the issuance of fines for violations and a trespass order that banned people experiencing homelessness from public parks prior to charging them with misdemeanor criminal trespass. 18 in fact, johnson clarified how civil fines levied against people experiencing homelessness were a method of cruel and unusual punishment. however, on january 12, 2024, the u.s. supreme court granted the city of grants pass’ petition for certiorari19 to reconsider the ruling. ————————————————————————————— 11. martin, 920 f.3d at 617. 12. see better days ahead outreach v. borough of pottstown, 2023 wl 8237255 1, 4-5 (e.d.p.a. 2023) (examining the pottstown case as “strikingly similar to martin” for pottstown’s increasing homeless population, lack of sufficient shelter space, and the shelter policies in existence that precluded people experiencing homelessness to access their services, while reaffirming how “the eighth amendment prohibits the state from punishing an involuntary act or condition if it is the unavoidable consequence of one’s status or being.”). 13. see barnes v. jeffreys, 529 f.supp.3d 784, 794-95 (n.d.i.l. 2021) (granting plaintiffs’ (i.e., sex offenders experiencing homelessness) motion for summary judgment on eighth amendment grounds as a statute operating “to keep indigent and homeless sex offenders incarcerated beyond their term of imprisonment” was deemed unconstitutional under the martin principle). 14. see char v. simeona, 2018 wl 4323894 1, 5 (d. hawai’i, 2018) (relying, in part, on martin for assessing the validity of a malicious prosecution claim before seeking relief under sec. 1983). 15. see phillips v. city of cincinnati, 2019 wl 2289277 1, 2 (s.d. o.h. 2019) (acknowledging that though the sixth circuit has not addressed criminalization of homelessness issues, the ninth circuit, in martin, ruled that an “ordinance violates the eighth amendment insofar as it imposes criminal sanctions against homeless individuals for sleeping outdoors, on public property, when no alternative shelter is available to them”). 16. see gbalazeh v. city of dallas, 394 f.supp.3d 666, 671 (n.d. t.x. 2019) (adopting the ninth circuit’s logic under martin for determining scope of retroactive and prospective relief). 17. johnson v. city of grants pass, 50 f.4th 787, 804 (9th cir. 2022) (amended and superseded on denial of re-hearing en banc by johnson v. city of grants pass, 72 f.4th 868 (9th cir. 2023)). 18. johnson v. city of grants pass, 72 f.4th 868, 896 (9th cir. 2023) (“our decision reaches beyond martin slightly. we hold, where martin did not . . . that martin applies to civil citations where, as here, the civil and criminal punishments are closely intertwined.”). 19. see petition for writ of certiorari, city of grants pass v. johnson, u.s. 1, 6 (2023) (no. 23-175) (signaling a written request on behalf of the city of grants pass, oregon, for the u.s. 2024] with liberty and justice for all 253 should the case be overturned, cities and localities across the country could renew efforts to arrest or fine people experiencing homelessness for simply surviving in public in the absence of safe shelter elsewhere. 20 of graver concern, overturning could lead to a dangerous slippery slope around eighth amendment limits: deciding what other involuntary statuses may be criminalized or fined. currently, with unsheltered homelessness exceeding sheltered homelessness since 2020 21—cities “are scrambling to comply with” martin and its progeny. 22 while martin and johnson have offered much needed commentary decrying the criminalization of homelessness, local governments, like boise, have erroneously claimed that their decisions have created a constitutional “right” to camp and reside in public parks and on sidewalks, mostly on public health and safety grounds. 23 mayors , 24 governors, 25 chambers ————————————————————————————— supreme court to review the judgment of the u.s. court of appeals for the ninth circuit—”the ninth circuit’s arrogation of quintessential policymaking authority over public health and safety has struck a blow not only to the principle of democratic governance, but also to the practical ability of cities to address the growth of public encampments. only this court can end this misguided project of federal courts dictating homelessness policy under the banner of the eighth amendment.”). 20. see “statement: scotus takes up johnson v. grants pass, the most significant case about homelessness in 40+ years,” nat’l homelessness l. ctr. (jan. 12, 2024), https://homelesslaw.org/statement-johnsonvgrantspass/. [https://perma.cc/f842-djgc] 21. see “fact sheet: 2023 annual homelessness assessment report,” u.s. dep’t hous. & urban dev. (dec. 1, 2023), https://www.hud.gov/sites/dfiles/pa/documents/hud_no_23_278_ 4.pdf [https://perma.cc/rh75-vz8v]; see also generally nat’l l. ctr. on homelessness & poverty, don’t count on it: how the hud point-in-time count underestimates the homelessness crisis in america (2017), https://homelesslaw.org/wp-content/uploads/ 2018/10/hud-pit-report2017.pdf [https://perma.cc/e48h-x4m4 ] (examining how hud’s pit count is a substantial undercount that applies a narrow definition of homelessness, systematically undercounts unsheltered adults and youth, and varies in its methodology). 22. rachel cohen, the little-noticed court decision that changed homelessness in america, vox (june 12, 2023), https://www.vox.com/23748522/tent-encampments-martin-boisehomelessness-housing [https://perma.cc/zrh4-2999]. 23. patrick sisson, homeless people gain ‘de facto right’ to sleep on sidewalks through federal court, curbed (dec. 16, 2019, 11:23 am), https://archive.curbed.com/2019/4/5/1829 6772/supreme-court-homeless-lawsuit-boise-appeals-court [https://perma.cc/g7xt-kkk3]. 24. see brandon hollingsworth, woodward joins national push to overturn martin v. boise ruling, spokane pub. radio (oct. 4, 2023, 4:55am pdt), https://www.spokane publicradio.org/regional-news/2023-10-04/woodward-joins-national-push-to-overturn-martin-vboise-ruling [https://perma.cc/29ep-qjfg]. 25. see jay barmann, city of san francisco files brief with supreme court on homeless encampment case, sf news (oct. 5, 2023), https://sfist.com/2023/10/05/san-francisco-mayorand-city-attorney-file-brief-with-supreme-court-on-homeless-encampment-case/ [https://perma.cc/f4lj-uvjx ] (“governor gavin newsom, for his own political reasons, has been vocal in seeking supreme court intervention on the issue, and essentially admitting that he hopes the conservative majority on the court will help in this case.”). https://perma.cc/f4lj-uvjx https://sfist.com/2023/10/05/san-francisco-mayor https://perma.cc/29ep-qjfg https://publicradio.org/regional-news/2023-10-04/woodward-joins-national-push-to-overturn-martin-v https://www.spokane https://perma.cc/g7xt-kkk3 https://archive.curbed.com/2019/4/5/1829 https://perma.cc/zrh4-2999 https://www.vox.com/23748522/tent-encampments-martin-boise https://perma.cc/e48h-x4m4 https://homelesslaw.org/wp-content/uploads https://perma.cc/rh75-vz8v https://www.hud.gov/sites/dfiles/pa/documents/hud_no_23_278 https://perma.cc/f842-djgc https://homelesslaw.org/statement-johnsonvgrantspass indiana health law review [vol. 21:249 254 of commerce, 26 public civic organizations, 27 and other entities have opposed these rulings, invoking separation of powers concerns. primarily, they argue that courts are intervening in policy matters reserved to the legislature. specifically claiming that judges are not well-suited in micromanaging public policy issues—like homelessness—that are based on apparent ill-defined rules. 28 neither martin nor johnson overturned laws punishing people experiencing homelessness on account of their poverty status, nor did they equip local municipalities with the appropriate financial or political incentives to invest in humane, adequate housing solutions. both rulings were insufficient in jurisdictions where alternative shelter accommodation is available, enabling the false narrative of service resistance 29 that continues to paint people experiencing homelessness in a culpable light for refusing to accept temporary shelter services. the courts left “ample power to police [to] punish homeless people” while also “regulat[ing] and restrict[ing] their access to public space.”30 ————————————————————————————— 26. see generally brief of amici curiae los angeles area chamber of commerce and central city association of los angeles in support of petitioner, city of grants pass v. johnson, ___ u.s. 1 (2023) (no. 23-175) (arguing that should martin and johnson remain intact, “they will continue to interfere with the efforts of local governments to enact and enforce reasonable regulations to protect public health and safety”). 27. see alexander l. merritt et al., supreme court weighs whether to clarify camping bans and homelessness policies, 14 nat’l l. rev. (nov. 16, 2023), https://www.natlawreview. com/article/supreme-court-weighs-whether-clarify-camping-bans-and-homelessness-policies [https://perma.cc/sv88-mfth] (stating how the california state association of counties and the league of california cities contend that martin and johnson have created an “unworkable” standard for governments to address homelessness). 28. see, e.g., brief for california governor gavin newsom as amicus curiae supporting petitioner at 2, city of grants pass v. johnson, 217 l. ed. 2d 341 (2024) (no. 23-175), 2024 u.s. lexis 422 (“the governor thus has a strong interest in ensuring that judicially created rules . . . do not hamstring state and local governments’ ability to address these problems, and do not impede common-sense measures to keep people safe.”). 29. see new york university, study counters narrative that street homeless are ‘service resistant,’ phys.org (june 10, 2019), https://phys.org/news/2019-06-counters-narrative-streethomeless-resistant.html [https://perma.cc/fjf4-u92j] (“these barriers [for finding housing] are exacerbated by [people experiencing homelessness’] reasonable aversion to shelters seen as overcrowded and unsafe. ‘in the process of trying to secure safe, permanent housing there is almost no light at the end of the tunnel and little to be gained by cooperation when the results are so disappointing. in this context, homeless people are not ‘service resistant,’ they are rational actors all too familiar with un-kept promises,’”) (quoting dr. deborah padgett at n.y.u. silver school of social work). 30. eighth amendment – criminalization of homelessness – ninth circuit refuses to reconsider invalidation of ordinances completely banning sleeping and camping in public, 133 harv. l. rev. 699, 704 (2019); see also lillian hernandez caraballo, despite public criticism, orlando passes ordinance banning people from blocking sidewalks, wmfe (jan. 9, 2024, 10:32am est), https://www.wmfe.org/housing-homelessness/2024-01-09/orlando-passesordinance-banning-people-blocking-sidewalks [https://perma.cc/8qtz-f8ty] (reporting a new ordinance enacted by the orlando city council that allows police to arrest or fine anyone intentionally blocking public sidewalks, which community members and homeless rights advocates fear “might be used to disproportionately target orlandoans living unsheltered.”). https://perma.cc/8qtz-f8ty https://www.wmfe.org/housing-homelessness/2024-01-09/orlando-passes https://perma.cc/fjf4-u92j https://phys.org/news/2019-06-counters-narrative-street https://phys.org https://perma.cc/sv88-mfth https://www.natlawreview 2024] with liberty and justice for all 255 b. the courts’ failure to recognize poverty as a suspect class under the equal protection clause and their limited power to fix socioeconomic issues even as the martin and johnson rulings have defended and enforced the eighth amendment rights of people experiencing homelessness, the courts’ adjudicatory authority to rule on matters of poverty and wealth is still concerningly limited. the dicta interpreting the equal protection clause of the federal constitution’s fourteenth amendment did not recognize poverty as a suspect classification. in what some scholars have argued is the “most famous footnote in constitutional law,”31 justice harlan stone penned that the u.s. supreme court would continue to apply a heightened scrutiny standard to laws and regulations “prejudice[d] against discrete and insular minorities.”32 subsequent decisions relied on this broad language to ascribe constitutional protections to minority groups based on race, birthing the “strict scrutiny” standard to say that a law needed to be “narrowly tailored . . . to achieve a compelling governmental interest” to survive a standard of review predicated on race. 33 this scrutiny standard often attributed to a class of individuals historically subjected to discrimination—termed “suspect classification”34— was never extended to individuals with disabilities, nor has constitutional law offered sufficient space outside of the equal protection clause context to explore the intersections of disability law, mental health, and poverty. 35 recognizing this gap in legal doctrine is important for establishing broader interpretations and reforms of the strict scrutiny standard so as to embolden the rights of people experiencing homelessness and people with mental health disabilities. ————————————————————————————— 31. peter linzer, the carolene products footnote and the preferred position of individual rights: louis lusky and john hart ely vs. harlan fiske stone, 12 const. comm. 277, 277 (1995). 32. united states v. carolene products co., 304 u.s. 144, 152 (1938) (determining that the rational basis standard of review applied to “regulatory legislation affecting ordinary commercial transactions” may not be extended to other legislation that “appears on its face to be within a specific prohibition of the constitution, such as those of the first ten amendments,” as the latter may be subjected to higher judicial scrutiny). 33. see generally april j. anderson, cong. rsch. serv., r47471, the constitution and race-conscious government action: narrow tailoring requirements, (march 14, 2023), (analyzing the strict-scrutiny test as it focuses on racial classifications). 34. see generally marcy strauss, reevaluating suspect classifications, 35 seattle univ. l. rev. 135 (2011) (discussing how courts have varied in their interpretation of suspect classification, weighing factors of historical discrimination, political powerlessness, and discrete and insular minority statuses). 35. see michael waterstone, disability constitutional law, 63 emory l. j. 527, 527 (2014) (“the largest constitutional ‘moment’ for disability law was the supreme court’s decision in city of cleburne v. cleburne living center, inc. there, while striking down a zoning ordinance as infringing the equal protection rights of individuals with mental retardation, the court held that the disability classification was only entitled to rational basis scrutiny. . . constitutional law has evolved, but it has stayed frozen in time for people with disabilities.”). indiana health law review [vol. 21:249 256 in the mid-1950s, the u.s. supreme court began narrowly considering equal protection principles and socioeconomic issues of poverty. the 1956 decision of griffin v. illinois held that a denial of an indigent person’s appeal of their criminal conviction for their inability to afford a transcript was discriminatory on the basis of poverty. 36 although the griffin court assessed equal protection in the context of one’s economic conditions, its ruling was still restricted to the way those conditions were shown to affect convicted indigent persons in criminal appellate procedure. accordingly, it did not declare that a state should “correct or cushion” those conditions responsible for indigents’ status of poverty.37 a string of subsequent decisions linking individuals’ status of indigency, economic oppression, and the equal protection clause arose regarding court fees, 38 welfare benefits, 39 and education. 40 the outcomes of these cases varied, based on what the court considered a fundamental constitutional right (i.e., education was not treated as such, while access to court process was). relatedly, the u.s. supreme court ruled that “the assurance of adequate housing” was a legislative rather than a judicial function, 41 interpreting one’s “need for decent shelter” and “right to retain peaceful possession of [his or her] home” as outside the scope of a constitutional mandate for court systems to decide on. 42 we extrapolate that the courts were underscoring judicial economy when opining a limited availability of judicial remedies and operations in redressing “every ————————————————————————————— 36. griffin v. illinois, 351 u.s. 12, 17 (1956) (“in criminal trials a state can no more discriminate on account of poverty than on account of religion, race, or color.”). 37. id. at 23 (concurring, j. frankfurter) (“a man of means may be able to afford the retention of an expensive, able counsel not within reach of a poor man’s purse. those are contingencies of life which are hardly within the power, let alone the duty, of a state to correct to correct or cushion. but when a state deems it wise and just that convictions be susceptible to review by an appellate court, it cannot by force of its exactions draw a line which precludes convicted indigent persons . . . from securing such a review merely by disabling them from bringing to the notice of an appellate tribunal errors of the trial court . . . .”). 38. see generally boddie v. connecticut, 401 u.s. 371 (1971) (holding that denying those who could not afford a fee the access to a divorce proceeding was unconstitutional on procedural due process grounds (i.e., requiring a meaningful opportunity to be heard) and substantive due process grounds (i.e., recognizing marriage as a fundamental interest at stake)). 39. see generally dandridge v. williams, 397 u.s. 471 (1970) (upholding a maryland state law that allocated its welfare payments to families with dependent children on the basis that the state demonstrated a “legitimate interest in encouraging employment and in avoiding discrimination between welfare families and the families of the working poor”). 40. see generally san antonio indep. sch. dist. v. rodriguez, 406 u.s. 966 (1973) (upholding a funding scheme across a texas school district by finding it not to have discriminated against the poor, and deciding further that because education is not a fundamental right under the constitution, strict scrutiny of the funding scheme was not required); but see generally plyler v. doe, 457 u.s. 202 (1982) (holding that undocumented persons, as persons “in any ordinary sense of the term” were to be afforded fourteenth amendment protections and that a state law severely disadvantaging the children of undocumented persons by denying them a right to education was unconstitutional under the equal protection clause). 41. lindsey v. normet, 405 u.s. 56, 74 (1972). 42. id. at 73-74. 2024] with liberty and justice for all 257 social and economic ill”,43 including inadequate, unaffordable housing. in turn, this limitation affected the ways that litigants experiencing poverty could challenge facially discriminatory laws and policies. it is, thus, unsurprising that the courts’ failure to recognize a fundamental constitutional right to housing bore direct consequences on people experiencing homelessness as a cause and consequence of their condition of poverty. the u.s. supreme court’s failure in determining if “the indicia of suspectness apply to the poor in america,” might help explain why laws and practices criminalizing people experiencing homelessness—especially those with health conditions—are not subject to a heightened judicial scrutiny in the ways that alienage, race, gender, and certain other protected categories are.44 consequently, the court has overlooked key historical and present-day realities connecting race and racism to poverty. it has also overlooked ways that cycles of poverty stem from intergenerational trauma. these considerations qualify one’s status of poverty as an immutable characteristic or historically discriminated condition to be classified as quasi-suspect or suspect under the equal protection clause.45 iii. criminalization of homelessness and mental health the courts’ limited success in enforcing anti-discrimination and equal protection provisions on behalf of people experiencing homelessness and people with disabilities forces us to look beyond judicial powers in discussions about decriminalizing homelessness. scapegoating these individuals for issues related to crime or public safety has perpetuated violent hate crimes against them. research studies have demonstrated that “mental illness alone is not a predictor of violence and that people with mental illness are actually more likely to be victims of violence than perpetrators”. 46 the disproportionately high incidence ————————————————————————————— 43. id. at 74. 44. henry rose, the poor as a suspect class under the equal protection clause: an open constitutional question, 34 nova l. rev. 407, 421 (2010). 45. an analysis was developed to explore the socioeconomic bias of the judges on the bench. see generally michele benedetto neitz, socioeconomic bias in the judiciary, 61 golden gate univ. sch. l. (2013) (recognizing that a privileged socioeconomic status of many judges may make them highly susceptible to implicit bias that affects their judicial opinions). we ascertain that in the context of homelessness, such judges would not understand why one would opt to sleep on the streets—subject to police interrogation, the weather, litter, etc.—instead of inside a congregate shelter. in many cases, the streets are safer. 46. joanna laine, from criminalization to humanization: ending discrimination against the homeless, 39 harbinger 1, 3-4 (2015) (citing margarita tartakovsky, media’s damaging depictions of mental illness, pysch central, https://psychcentral.com/lib/medias-damagingdepictions-of-mental-illness#1 [https://perma.cc/ud4r-qyj6] (may 17, 2016) (quoting cheryl k. olson, sc.d., co-director of the center for mental health and media at massachusetts general hospital department of psychiatry)); see linda a. teplin et al., crime victimization in adults with severe mental illness, 62 arch. gen. psychiatry 911, 914 (2005) (“over one quarter of the smi sample had been victims of a violent crime . . . in the past year, 11.8 times higher than the [general population] . . .”). https://perma.cc/ud4r-qyj6 https://psychcentral.com/lib/medias-damaging indiana health law review [vol. 21:249 258 of physical, mental, and psychological health disparities amongst people experiencing homelessness has worsened in recent years. an estimated 31% of people experiencing homelessness nationwide have at least one serious mental illness, contrasting to the 5.5% of the rest of the public. 47 mental health conditions are prone to worsen with the existence of homelessness and in the absence of housing.48 furthermore, those individuals living in “socially underprivileged and poor city areas” more often experience “depression, anxiety and psychosis” than those in higher-income neighborhoods.49 a. historical underpinnings the dehumanizing derogatory language our culture uses to describe people with mental disabilities who experience homelessness contributes to their criminalization. both the criminalization of homelessness and the criminalization of mental health draw from the damaging, misguided premise that these individuals are blameworthy for “causing” their own conditions, and, consequently are less deserving of life. 50 as far back as the 1700s, many people with mental health disabilities were imprisoned for being societally deemed as “barbaric” and having “incurable” moral failings, while others were hidden in attics and sheds by their families “in order to avoid [public] embarrassment.”51 although mid-19 th century reform efforts sought to help incarcerated people with mental health disabilities, the establishment of publicly funded psychiatric hospitals was closely followed by the inhumane eugenics movement. 52 broadly, ————————————————————————————— 47. health, nat’l all. to end homelessness, https://endhomelessness.org/homelessnessin-america/what-causes-homelessness/health/#:~:text=health%20and%20homelessness,an%20acute%20physical&text=on%20a%20given%20night%20in,11%2c000%20people%20 had%20hiv%2faids [https://perma.cc/q6nw-f8ap] (dec. 2023). 48. homelessness & health: what’s the connection, nat’l health care for homeless council 1, 1 (feb. 2019), https://nhchc.org/wp-content/uploads/2019/08/homelessness-andhealth.pdf [https://perma.cc/gg9r-kds8]. 49. derin marbin et al., perspectives in poverty and mental health, 10 frontiers pub. health 1, 2 (2022), https://doi.org/10.3389/fpubh.2022.975482 [https://perma.cc/8l8v-lvzd]. 50. see taylor griggs, homelessness is not a personal failure, invisible people (june 8, 2021), https://invisiblepeople.tv/homelessness-is-not-a-personal-failure/ [https://perma.cc/x6jq7l4u]. 51. covering mental health: 1840s-1890s, pbs newshour classroom, https://www. journalisminaction.org/case/nellie-bly (last visited sept. 6, 2023) [https://perma.cc/88bldzhy]. 52. see alisa roth, the truth about deinstitutionalization, atlantic (may 25, 2021), https://www.theatlantic.com/health/archive/2021/05/truth-about-deinstitutionalization/618986/ [https://perma.cc/6xdg-vn4d] (“in 1841, a former schoolteacher named dorothea dix visited a massachusetts jail to teach a bible class. she was appalled to find it filled with people with mental illness, living in horrific conditions; traveling around the country, she found similar conditions in other jails. residents were kept in ‘cages, closets, cellars, stalls, pens!’ she later wrote in a letter to the massachusetts legislature.”); see also “the 19th century asylum,” hearing voices, https://librarycompany.org/hearingvoices-online/section1.html (last visited sept. 6, 2023) [https://perma.cc/l4ug-beuv] (“the theory of degeneracy and the eugenics movement https://perma.cc/l4ug-beuv https://librarycompany.org/hearingvoices-online/section1.html https://perma.cc/6xdg-vn4d https://www.theatlantic.com/health/archive/2021/05/truth-about-deinstitutionalization/618986 https://perma.cc/88bl https://journalisminaction.org/case/nellie-bly https://www https://perma.cc/x6jq https://invisiblepeople.tv/homelessness-is-not-a-personal-failure https://perma.cc/8l8v-lvzd https://doi.org/10.3389/fpubh.2022.975482 https://perma.cc/gg9r-kds8 https://nhchc.org/wp-content/uploads/2019/08/homelessness-and https://perma.cc/q6nw-f8ap https://endhomelessness.org/homelessness 2024] with liberty and justice for all 259 this movement emerged in an attempt to eliminate so-called “social ills,” targeting certain groups of people, including those living in poverty and those experiencing homelessness. 53 more narrowly, its link to forced sterilization— described by the misnomer of the progressive era—were central issues that the u.s. supreme court subsequently adjudicated in one of its most harmful rulings. in a 1927 majority opinion authored by justice oliver wendell holmes, jr., “mental defectives” needed to be sterilized to promote their “welfare and that of society”. 54 a century later, it is beyond troubling to revisit this language coined by the nation’s highest court, which reduced the worth of persons with mental disabilities to “imbeciles” who were “manifestly unfit” for human society (“three generations of imbeciles are enough.”).55 the ruling triggered forced sterilization of as many as 70,000 individuals during the 20th century, dangerously upholding the state’s right to determine one’s fitness to procreate. 56 this speaks volumes about how state power has segregated and weaponized individuals with mental health disabilities, and how our country’s history of eugenics deliberately undercut their fundamental rights to life and liberty. it further reinforces the concern of why courts have failed to ascribe fourteenth amendment suspect classification to this population along with people living in poverty—as the eugenics movement demonstrated, these groups endured a history of purposeful unequal treatment and political powerlessness. 57 policies born out of eugenics legacies continue to affect interconnected issues of race, poverty, and mental health. poor women of color, particularly, were subjected to forced sterilizations well into the 1960s and 1970s, “often while seeking another type of surgery or after childbirth.”58 it reinforced the punitive notion that people living in poverty needed to be “fixed,” and that they lacked autonomy as an “undesirable” population.59 concurrent with the rise of these policies was states’ increased investment in their own state-run psychiatric ————————————————————————————— it precipitated led to the forced sterilization of countless mentally ill patients to prevent the inheritance of insanity.”). 53. see “fact sheet: eugenics and scientific racism,” nat’l hum. genome rsch. inst. (may 18, 2022), https://www.genome.gov/about-genomics/fact-sheets/eugenics-and-scientificracism#:~:text=eugenicists%20worldwide%20believed%20that%20they%20could%20perfect %20human,of%20individuals%20deemed%20by%20them%20to%20be%20unfit. [https://perma.cc/47sw-6q8c] 54. buck v. bell, 274 u.s. 200, 205-07 (1927). 55. id. at 207. 56. the supreme court ruling that led to 70,000 forced sterilizations, npr (march 7, 2016), https://www.npr.org/sections/health-shots/2016/03/07/469478098/the-supreme-courtruling-that-led-to-70-000-forced-sterilizations [https://perma.cc/ur5j-r9vv]. 57. see rose, supra note 44, at 421 (describing the “‘traditional indicia of suspectness’”); see also strauss, supra note 34. 58. caitlin fendley, eugenics is trending. that’s a problem., wash. post (feb. 17, 2020, 6:00am est), https://www.washingtonpost.com/outlook/2020/02/17/eugenics-is-trendingthats-problem/ [https://perma.cc/dm2c-pa35]. 59. lisa ko, unwanted sterilization and eugenics programs in the united states, pbs indep. lens (jan. 29, 2016), https://www.pbs.org/independentlens/blog/unwanted-sterilizationand-eugenics-programs-in-the-united-states/ [https://perma.cc/rn7w-2q7x]. https://perma.cc/rn7w-2q7x https://www.pbs.org/independentlens/blog/unwanted-sterilization https://perma.cc/dm2c-pa35 https://www.washingtonpost.com/outlook/2020/02/17/eugenics-is-trending https://perma.cc/ur5j-r9vv https://www.npr.org/sections/health-shots/2016/03/07/469478098/the-supreme-court https://perma.cc/47sw-6q8c https://www.genome.gov/about-genomics/fact-sheets/eugenics-and-scientific indiana health law review [vol. 21:249 260 facilities designed to involuntarily institutionalize persons with mental and behavioral health disabilities. 60 by the 1950s, the numbers of institutionalized patients had vastly exceeded discharged patients, with only twenty-five u.s. cities having a population exceeding that of public psychiatric institutions. 61 in a federal effort to deinstitutionalize publicly funded hospitals, thenpresident john f. kennedy issued the 1963 community mental health act (“cmha”). 62 we interpret the cmha as one of the earlier preceptors of the housing first model.63 it purported to shift the treatment of people with mental health disabilities from state psychiatric facilities to local, “self-sufficient” community-based clinics. 64 this aim was furthered by the creation of medicaid and medicare two years after cmha’s implementation. 65 medicaid’s incorporated “imd” exclusion, prohibiting the use of federal medicaid funds to provide inpatient care or services to people between the ages of twenty-one and sixty-four in “institutions for mental disease”—e.g., facilities where over 50% of its residents were institutionalized for “mental disease” as their main reason 66—was itself a product of the deinstitutionalization movement. 67 this ————————————————————————————— 60. elliott young, locking up the mentally ill has a long history, wash. post (jan. 3, 2023, 6:00 am), https://www.washingtonpost.com/made-by-history/2023/01/03/history-mentalillness-incarceration/ [https://perma.cc/tt2b-24tq]. the new york lunacy commission found in 1912 that one-third of new york’s budget “was spent locking up and caring for the mentally ill.” the state’s office of mental hygiene was established in 1926, with its very name suggesting eugenicist undertones of “disinfecting” persons with mental and behavioral health disabilities. 61. id. 62. see vic digravio, the last bill jfk signed – and the mental health work still undone, wbur (oct. 23, 2013), https://www.wbur.org/news/2013/10/23/community-mental-healthkennedy (“. . . president kennedy called for society to embrace a new vision for people with mental health disorders and developmental disabilities, one in which the ‘cold mercy of custodial care would be replaced by the open warmth of community.’”). 63. housing first is an evidence-based policy approach for connecting individuals and families experiencing homelessness to permanent supportive housing, or housing that contains few to no programmatic requirements to entry (i.e., sobriety, treatment, or service participation requirements). see housing first in permanent supportive housing, hud exchange, https://files.hudexchange.info/resources/documents/housing-first-permanent-supportivehousing-brief.pdf [(last visited jan. 24, 2024). 64. see blake erickson, deinstitutionalization through optimism: the community mental health act of 1963, 16 am. j. psychiatry residents’ j. 6,6 (2021); see also digravio, supra note 62.. 65. see jennifer mathis et al., medicaid’s institutions for mental diseases (imd) exclusion rule 10 (2018), https://www.scattergoodfoundation.org/wp-content/uploads/2021/ 02/medicaids-institutions-for-mental-diseases-imd-exclusion-rule.pdf [https://perma.cc/7v zr-wqh6] (discussing how medicaid and medicare, borne out of the 1965 social security amendments, financially incentivized states to shift from psychiatric hospitals to communitybased services, the former of which contained dehumanizing conditions with care that were often “purely custodial” in nature); see also jennifer mathis, medicaid’s institutions for mental diseases (imd) exclusion rule: a policy debate—argument to retain the imd rule, 70 psychiatric servs. 4, 4 (2019). 66. see megan houston, cong. rsch. serv., medicaid’s institution for mental diseases (imd) exclusion 1 (2023), https://crsreports.congress.gov/product/pdf/if/if10222. 67. mathis, supra note 65, at 4. https://crsreports.congress.gov/product/pdf/if/if10222 https://perma.cc/7v https://www.scattergoodfoundation.org/wp-content/uploads/2021 https://files.hudexchange.info/resources/documents/housing-first-permanent-supportive https://www.wbur.org/news/2013/10/23/community-mental-health https://perma.cc/tt2b-24tq https://www.washingtonpost.com/made-by-history/2023/01/03/history-mental 2024] with liberty and justice for all 261 exclusion policy, in part, was intended to financially incentivize states to invest in community-based services instead of institutions. 68 vowing to reduce the population of 600,000 people institutionalized for apparent psychological disabilities by half, president kennedy’s vision considered supportive housing advancements. 69 however, many psychiatrists cautioned that for a community model under the cmha to operate effectively, mental health professionals needed to address specific determinants such as “poor socialization and lack of housing, food, and clothing” that were root causes of the mental health crisis. 70additionally, as well-intended as chma was, it was never adequately funded to create the community clinics needed to transition individuals with mental health disabilities from larger institutions to housing and community-based services, resulting in many of them simply being discharged into the streets. paired with the loss of deeply affordable single room occupancy (“sro”) housing units, where at least some could find housing, this contributed substantially to the growth of modern homelessness. states and municipalities gradually adopted their own deinstitutionalization (and institutionalization) standards, while rates of homelessness and untreated mental illness still proliferated. in his capacity as california’s governor, ronald reagan signed the lanterman-petris-short (“lps”) act,71 which set into motion “modern mental health commitment procedures”.72 while lps intended to end the involuntary commitment of individuals with mental and developmental disabilities, and chronic alcoholism, its funding was not reserved for community-based services or non-state funded mental health facilities. moreover, it introduced narrower criteria for detention and greater judicial oversight of the institutionalization process. 73 the criteria it established for a psychiatric “5150 hold”—a strict seventy-two-hour involuntary treatment— required a probable cause showing to believe that the individual was a danger to themselves or others or considered “gravely disabled” because of their mental health condition(s). 74 the former criteria of posing a danger to self or others ————————————————————————————— 68. see mathis et al., supra note 65, at 25; see also macpac, report to congress on oversight of institutions for mental diseases 4 (2019), https://www.macpac.gov/wpcontent/uploads/2020/01/report-to-congress-on-oversight-of-institutions-for-mental-diseasesdecember-2019.pdf [https://perma.cc/5ept-lsx7]. 69. erickson, supra note 64, at 6; see robert c. toth, president seeks funds to reduce mental illness, n.y. times (feb. 6, 1963), https://timesmachine.nytimes.com/timesmachine/ 1963/02/06/89517937.html [https://perma.cc/679r-8ba6]. 70. erickson, supra note 64, at 7. 71. see generally cal. welf. & inst. code § 5000 et seq. (1967) (amended by stats. 2022) [hereinafter lps act]. 72. what is the lanterman-petris short act?, superior ct. cali.: cnty. l.a., https:// www.lacourt.org/division/mentalhealth/mh0017.aspx [https://perma.cc/pg78-l25h] (last visited dec. 17, 2023). 73. nathaniel p. morris, reasonable or random: 72-hour limits to psychiatric holds, 72 psychiatric servs. 210, 210-11 (2021). 74. lps act § 5150; see diane y. byun, gravely disabled: the vestigial prong of 5150 designations, 34 j. l. & health 192, 203-05 (detailing the criteria that a police officer must rely on in making a 5150 designation). https://perma.cc/pg78-l25h https://www.lacourt.org/division/mentalhealth/mh0017.aspx https://perma.cc/679r-8ba6 https://timesmachine.nytimes.com/timesmachine https://perma.cc/5ept-lsx7 https://www.macpac.gov/wp indiana health law review [vol. 21:249 262 does not require a risk of violent behavior or propensities, but most often has been qualified by threats or attempts at self-harm, suicidal ideation, or threats to harm others. 75 meanwhile, the grave disability standard has since evolved to mean that the individual cannot provide for their own basic needs for food, clothing, or shelter on account of a mental illness. 76 even if this definition does not read explicitly as saying people experiencing homelessness are “gravely disabled” by virtue of being homeless, it discounts the structural conditions and policy failures that make accessing housing or shelter unsustainable and untenable. given the state of psychiatric facilities through the 1950s and 60s, we view the ‘deinstitutionalization’ label commonly used to describe this era as a misnomer. 77 while the cmha, lps act, and other related laws and policies, took effect, federal courts continued to issue conflicting rulings regarding the legal standards that authorized involuntary commitments of people with mental health disabilities. such standards exhibited the overreach of judiciary function in establishing institutionalization parameters, though not always in a light unfavorable to institutionalized patients. the u.s. supreme court, for instance, sided with the state of wisconsin’s statutory definition of “mental illness” in its 1972 decision of lessard v. schmidt in holding that institutionalization was warranted should “the potential for doing harm be ‘great enough to justify such a massive curtailment of liberty.’”78 the lessard decision established the strictest possible standard—beyond a reasonable doubt—that considered an involuntarily committed individual’s “loss of basic civil rights and loss of future opportunities,” including their access to housing and employment. 79 it also recognized the state’s responsibility to aid these individuals’ re-entry and readjustment to society, naming the stigmas of commitment in the public eye.80 it clarified the constitutional right to counsel to those navigating civil commitment proceedings, thus strengthening procedural due process arguments, asserting that the role of guardian ad litems insufficiently satisfied this right.81 ————————————————————————————— 75. see “understanding the lanterman-petris-short (lps) act,” disability rts. cali. (jan. 8, 2018), https://www.disabilityrightsca.org/publications/understanding-the-lanterman-petrisshort-lps-act [https://perma.cc/8tk6-83t8]. 76. lps act § 5008(h). 77. see jeffrey geller, “the rise and demise of america’s psychiatric hospitals: a tale of dollars trumping sense,” am. psychiatric ass’n: psychiatric news (march 14, 2019), https://psychnews.psychiatryonline.org/doi/10.1176/appi.pn.2019.3b29[https://perma.cc/nx73398y] (“whether deinstitutionalization has ever occurred remains a matter of debate.”). 78. lessard v. schmidt, 349 f. supp. 1078, 1093 (e.d. wis. 1972). 79. id. at 1090. 80. see, e.g., id., at 1085 (arguing how the criterion of “dangerousness” upon which commitment could be based “apparently rest[s] on the assumption that a state could proceed as parens patriae to protect the interests of the person involved.”). 81. id. at 1097-1100 (underscoring, in part, how the role of an attorney and the role of a guardian ad litem serve distinct functions, and that the former is no substitute for the latter when https://psychnews.psychiatryonline.org/doi/10.1176/appi.pn.2019.3b29[https://perma.cc/nx73 https://perma.cc/8tk6-83t8 https://www.disabilityrightsca.org/publications/understanding-the-lanterman-petris 2024] with liberty and justice for all 263 from these lenses, we interpret lessard’s holding and rationale as favorable to those individuals suffering from mental illness. but it also had its limitations, especially as it did not explicitly speak to the rights of people experiencing homelessness, their disproportionately higher propensity of undergoing an involuntary commitment, and their limited “less restrictive” alternatives for treatment outside of involuntary commitments. 82 it also derived its requirement of “dangerousness” from a separate u.s. supreme court case, humphrey v. cady, that interpreted the wisconsin statutory definition of mental illness without considering its constitutionality. 83 consequently, it still left up to the courts the parameters for determining an individual’s potential for harm, while arbitrarily equating the same standard for people with physical and mental health disabilities. three years after lessard was rendered, the u.s. supreme court’s o’connor v. donaldson ruling recognized “involuntary commitment to a mental hospital . . . for any reason, [to be] a deprivation of liberty which the state cannot accomplish without due process of law.”84 its standard for determining such confinement centered on whether a “non-dangerous individual [was] capable of surviving safely in freedom” independently or with the support of responsible community.85 mental health advocates have viewed this landmark decision in a favorable light for the strict standards set for detention of individuals with serious mental health conditions. it offered the much-needed commentary that the treatment needed for an individual with mental health disabilities did not, and should not, equate to a dangerousness standard. involuntary commitment, in the ways that an individual’s prolonged confinement violated their right to liberty, was a proxy of the criminal legal system and the harmful, irreversible effects of incarceration. moreover, its legacy gained traction over the coming decades when cities, “often under pressure from local businesses,” looked to dismantle mental facilities. 86 b. forced treatment schemes as proxies of the criminal legal system even with this ‘dismantlement’ legacy intact, our state and municipal governments still have not prioritized a well-funded community treatment ————————————————————————————— it comes to judicial hearings on civil commitments); see michael j. remington, lessard v. schmidt and its implications for involuntary civil commitment in wisconsin, 57 marquette l. rev. 65, 73-74 (1973) (“the more specific issue in the lessard case . . . is whether the wisconsin provision for a guardian ad litem serves a function different from that of adversary counsel . . . . [and that it] does not satisfy the constitutional right to counsel.”). 82. remington, supra note 81, at 77–78. 83. humphrey v. cady, 405 u.s. 504, 510 (1972) (“the statute authorizes renewal of the commitment order if the court finds that discharge would be ‘dangerous to the public because of the person’s mental or physical deficiency, disorder or abnormality.’”) (citing wis. stat. ann. § 975.14 (1971)). 84. o’connor v. donaldson, 422 u.s. 563, 580 (1975). 85. id. at 575. 86. allen pusey, a woman wins the right to be homeless, 103 a.b.a. j. 72, 72 (2017). indiana health law review [vol. 21:249 264 system or allocated sufficient resources for permanent supportive housing, housing vouchers, pathways to education, and job and vocational training. rather, we have seen the rise of civil commitment laws and policies, with countless individuals subjected to these schemes—disproportionately those experiencing homelessness—winding up in jails and prisons. these carceral facilities are “warehouses of people with serious mental illnesses, where what is most often meted out is punishment and brutality rather than treatment.”87 an estimated 44% of pre-trial detainees and 37% of prison detainees have a mental health condition. 88 furthermore, many people with mental health disabilities who are ensnared in the criminal legal system are also less likely to make bail, as they also often lack the financial support of friends, family, and community members and suffer instantaneous civil penalties (i.e., loss of employment and housing) because of a single arrest. 22,000 people, according to the prison policy initiative, are involuntarily committed across various institutional facilities “and many without any determined release date.”89 consequently, these individuals experience the devastating reality of languishing in jail at a rate “nearly twice as long as [persons] without mental [health disabilities].”90 some states, like idaho and mississippi, actively fund programs designed to detain psychiatric patients in prisons, using carceral facilities to “house” those who neither face a criminal trial nor charges. 91 in idaho particularly, correction officers can decide if an individual should be placed in prison rather than in a treatment facility. it has been a practice of several decades, despite attempts by mental health and homeless rights advocates to overhaul it. 92 this, if anything, reinforces how the carceral state violates the civil and human rights of individuals, including those committed by courts for forced treatment. it is separate from idaho’s court-ordered involuntary mental health commitment law requiring at least two professionals to ascertain whether an individual with mental health disabilities satisfies the “gravely disabled” legal standard.93 ————————————————————————————— 87. ayelet waldman, the legal fight that ended the unjust confinement of mental health patients, literary hub (jan. 21, 2020), https://lithub.com/the-legal-fight-that-ended-the-unjustconfinement-of-mental-health-patients/ [https://perma.cc/aj6a-tkqf]. 88. aashna lal, new york city’s involuntary commitment plan: fulfilling a moral obligation?, hastings center (jan. 10, 2023), https://www.thehastingscenter.org/new-yorkcitys-involuntary-commitment-plan-fulfilling-a-moral-obligation/ [https://perma.cc/dz5w-wv yx]. 89. derecka purnell, becoming abolitionists: police, protests, and the pursuit of freedom 216 (2021). 90. treatment, not jail, for the mentally ill, n.y. times (jan. 31, 2013), https://www .nytimes.com/2013/02/01/opinion/treatment-not-jail-for-the-mentally-ill-in-new-york-city.html. 91. audrey dutton, idaho keeps some psychiatric patients in prison, ignoring decades of warnings about the practice, propublica (dec. 13, 2023, 6:00am est), https://www. propublica.org/article/idaho-keeps-some-psychiatric-patients-in-prison-ignoring-decades-ofwarnings-about-the-practice. 92. id. 93. idaho code § 66-329(2) (2023). https://propublica.org/article/idaho-keeps-some-psychiatric-patients-in-prison-ignoring-decades-of https://www https://nytimes.com/2013/02/01/opinion/treatment-not-jail-for-the-mentally-ill-in-new-york-city.html https://www https://perma.cc/dz5w-wv https://www.thehastingscenter.org/new-york https://perma.cc/aj6a-tkqf https://lithub.com/the-legal-fight-that-ended-the-unjust 2024] with liberty and justice for all 265 relatedly, criminalization agendas enforced by former president trump further emboldened right-winged entities like the texas-based cicero institute94 to push punitive, non-evidence-based narratives about homelessness and public safety. specifically, the institute drafted a template state-level “cicero bill” that bans camping on statewide public lands, divest funding from permanent housing solutions towards mass encampments and police-led street outreach teams, and weaken due process protections that would enable the state to involuntarily commit people with mental health disabilities who experience homelessness. 95 while at least seven states—georgia, missouri, tennessee, texas, arizona, wisconsin, and oklahoma—have adopted some version of the cicero bill, 96 others, like kentucky, 97 have introduced related provisions that, though not explicitly based on the cicero bill, will likely criminalize people experiencing homelessness through anti-housing first agendas, under the guise of “tackling violent crime.” moreover, indiana introduced its own version of the cicero bill as of january 2024.98 slated to take effect on july 1, 2024, indiana house bill 1413 regards the prohibition of street camping and appropriation of state funds for temporary shelter, parking areas and camping facilities, 99 while it proposes to cancel fy 2025 funding appropriated for the housing first program. 100 meanwhile cities and states continue to find more creative ways to confine, rather than house. below are case studies of how new york city and california have resorted to the civil involuntary commitment system to effectively remove people experiencing street homelessness without addressing their underlying ————————————————————————————— 94. a new way on homelessness, cicero inst., https://ciceroinstitute.org/issues/ homelessness/ [https://perma.cc/4s6y-37q7] (last visited jan. 11, 2024). 95. see reducing street homelessness act of 2022, cicero inst. (2022), https:// ciceroinstitute.org/wpcontent/uploads/2021/11/reducing-street-homelessness-act-modelbill.090821.pdf [https://perma.cc/2xd4-lp3d] [hereinafter 2022 cicero bill]. 96. see clara bates, missouri’s new law criminalizing homelessness is already causing ‘uncertainty and fear, npr (jan. 17, 2023, 9:17 am), https://www.kcur.org/news/2023-0117/missouris-new-law-criminalizing-homelessness-is-already-causing-uncertainty-and-fear [https://perma.cc/k499-bhuc]; see also kristian hernandez, homeless camping bans are spreading. this group shaped the bills, gpb news (apr. 12, 2022, 11:30am), https://www. gpb.org/news/2022/04/12/homeless-camping-bans-are-spreading-group-shaped-the-bills [https:// perma.cc/7s6k-ckay]. 97. lawmakers file ‘safer kentucky act,’ aimed at tackling violent crime, wdrb (jan. 9, 2024), https://www.wdrb.com/news/politics/lawmakers-file-safer-kentucky-act-aimed-attackling-violent-crime/article_5e3d942c-af31-11ee-8d6a-67bd1c8300d2.html (“tuesday, lawmakers mentioned that municipalities or cities could create designated areas, like a parking lot, for encampments to operate. in an effort, their hope is to limit panhandling and dangerous conditions for those experiencing homelessness and the public.”) [https://perma.cc/m8nm85q8]. 98. see generally h.b. 1413, 123rd gen. assemb., reg. sess. (ind. 2024) (amending the indiana code regarding state and local administration of funds for housing or homelessness) [hereinafter ind. h.b. 1413]. 99. id. § 1 (adding chapter 12 to the indiana code proposing the cancelation of housing first funds for the state from july 1, 2024, through june 30, 2025). 100. id. § 1, 4 (adding chapters 12 and 31.5 to the indiana code concerning funds for parking areas, camping areas, and individual shelters, and the prohibition of street camping, respectively). https://perma.cc/m8nm https://www.wdrb.com/news/politics/lawmakers-file-safer-kentucky-act-aimed-at https://gpb.org/news/2022/04/12/homeless-camping-bans-are-spreading-group-shaped-the-bills https://www https://perma.cc/k499-bhuc https://www.kcur.org/news/2023-01 https://perma.cc/2xd4-lp3d https://ciceroinstitute.org/wpcontent/uploads/2021/11/reducing-street-homelessness-act-model https://perma.cc/4s6y-37q7 https://ciceroinstitute.org/issues indiana health law review [vol. 21:249 266 housing needs. moreover, they demonstrate how concerning it is for law enforcement officials to intervene as first responders in mental health crises. i. new york city’s involuntary mental health directive the politics of new york city’s so-called criminal justice reform measures and burgeoning homelessness epidemic are complicated and intertwined. rikers island, the nation’s most notorious prison industrial complex for its ongoing carceral culture of abuse, neglect, and punishment of detainees, is also coined new york’s largest psychiatric care provider. 101 half of rikers’ jail population (an estimated 2,780 detainees) have a mental health diagnosis on any given day. 102 and while rikers has operated for over ninety years, the new york city police department (“nypd”) predated it by nearly a full century. 103 in the early 1980s, the nypd established a homeless outreach unit aiming to relocate people experiencing homelessness out of subways and into temporary shelters and social service programs. 104 this structural change within the agency supplemented its pre-existing emergency service unit (“esu”) that was part of the special operations bureau since 1930. 105 the esu deliberately invested funds and resources into training nypd officers to deal with those they deemed “emotional disturbed people” (“edps”). 106 the high-profile murder of 66-year-old eleanor bumpers—a black, bronx resident who was experiencing a mental health crisis during her eviction from public housing 107—in 1984 triggered citywide use-of-force policy changes to be instituted against edps. 108 one of these changes consisted of requiring street-level nypd officers to wait until the arrival of a supervisor before confronting an epd in their line of ————————————————————————————— 101. annie mcdonough, mental health care on rikers: new york’s largest psychiatric provider, city & state (sept. 30, 2022), https://www.cityandstateny.com/policy/ 2022/09/mental-health-care-rikers-new-yorks-largest-psychiatricprovider/377870/. 102. id. 103. history of the new york city police department, pure hist. (may 11, 2012), https:// purehistory.org/history-of-the-new-york-city-police-department/. 104. lal, supra note 88. 105. matt coneybeare, [watch] new york police department highlights a vintage emergency services unit from 1930, viewing nyc (may 10, 2017, 11:30am), https:// viewing.nyc/watch-new-york-police-department-highlights-a-vintage-emergency-services-unitfrom-1930/. 106. purnell, supra note 89, at 222. 107. bumpers was a mother of seven and grandmother of ten. due to her “disability,” she received minimal government assistance, and she spent nearly a year in prison before moving to new york where she faced multiple arrests and involuntary commitments through the rest of her life. in the bronx particularly, she lived in deplorable living conditions, including broken pipes, defective kitchen, and a frequently flooded toilet, causing her to withhold her rent. purnell, supra note 89, at 221-22; see alan feuer, fatal police shooting in bronx echoes one from 32 years ago, n.y. times (oct. 19, 2016), https://www.nytimes.com/2016/10/20/nyregion/fatal-police-shooting-in-bronx-echoes-onefrom-32-years-ago.html. 108. see feuer, supra note 107. https://www.nytimes.com/2016/10/20/nyregion/fatal-police-shooting-in-bronx-echoes-one https://purehistory.org/history-of-the-new-york-city-police-department https://www.cityandstateny.com/policy 2024] with liberty and justice for all 267 duty.109 in the revamping of the nypd patrol guide, officers were generally required to “isolate . . . and establish a ‘zone of safety’” around those they believed to be “suspects in mental distress.”110 the year of bumpers’ murder brought upon nearly 34,000 epd calls to the nypd, over half of which were eligible for esu response. 111 however, this figure, if anything, is likely an undercount as the nypd has also injured or killed individuals outside of the esu’s purview. these targeted responses against edps have only accelerated in recent years. between 2009 and 2019, the number of edp calls increased from 97,000 to nearly 180,000, rising in every police precinct. 112 any discussion about new york city’s criminalization of mental health requires historical context of its policing policies and perpetual racial inequality. edp calls have disparately affected poorer, black and latino city residents. 113 more broadly, despite statistically suffering serious mental health conditions at a rate seven times less than non-black new yorkers, black new yorkers undergo a higher hospitalization rate. 114 former mayor ed koch authorized involuntary commitments of new yorkers in 1987, furthering a renewed era of institutionalization that has disproportionately targeted and affected people with mental health disabilities who experience homelessness. 115 almost thirty years later, former mayor bill de blasio created an inaugural task force on behavioral health and criminal justice, which, in part, incorporated a crisis intervention team (“cit”) training protocol for nypd officers when in contact with individuals with apparent mental health disabilities. presently, the cit program is “likely the largest in the nation,” having trained an estimated 10,000 officers on “de-escalation” techniques with edps since its inception. 116 even with the eventual dissolution of the nypd’s homeless outreach unit, 117 degrading, counterproductive practices designed to remove people ————————————————————————————— 109. see feuer, supra note 107. 110. see feuer, supra note 107. 111. purnell, supra note 89, at 223. 112. greg b. smith, the nypd’s mental illness response breakdown, the city (apr. 6, 2020, 4:57 pm), https://www.thecity.nyc/2019/03/21/the-nypd-s-mental-illness-response-break down/ [https://perma.cc/jp52-gvkq] 113. see id. (“. . . precinct-specific data indicating large numbers of mental health 911 calls in poorer neighborhoods mirror data showing that poorer black and hispanic neighborhoods register a higher number of psychiatric hospitalizations.”). 114. transcript of the minutes of the committee on public safety jointly with committee on fire and emergency management and committee on mental health, disabilities, and addiction, nyc city council, p. 21, ll. 23-25 (feb. 6, 2023) [hereinafter city council transcript]. 115. david oshinsky, it’s time to bring back asylums, wall st. j. (july 21, 2023, 10:56 am), https://www.wsj.com/articles/its-time-to-bring-back-the-asylum-ec01fb2. 116. stephen eide, systems under strain: deinstitutionalization in new york state and city, 10 (manhattan inst., nov. 2018) https://manhattan.institute/article/systems-understrain-deinstitutionalization-in-new-york-state-and-city [https://perma.cc/2qxw-jsgh]. 117. see courtney gross, nypd getting kicked out of homeless services, spectrum news ny1 (jul. 3, 2020, 6:07pm), https://ny1.com/nyc/all-boroughs/public-safety/2020/07/03/nypdgetting-kicked-out-of-homeless-services [https://perma.cc/ely9-zf6a]; see also #human plan: https://perma.cc/ely9-zf6a https://ny1.com/nyc/all-boroughs/public-safety/2020/07/03/nypd https://perma.cc/2qxw-jsgh https://manhattan.institute/article/systems-under https://www.wsj.com/articles/its-time-to-bring-back-the-asylum-ec01fb2 https://perma.cc/jp52-gvkq https://www.thecity.nyc/2019/03/21/the-nypd-s-mental-illness-response-break indiana health law review [vol. 21:249 268 experiencing homelessness from encampments and public spaces continue. upon taking office in 2022, mayor eric adams promulgated a series of criminalization agendas against people experiencing homelessness that escalated police violence. one policy—the mental health involuntary removals directive (“the directive”)—interpreted and expanded article 9 of the new york state mental hygiene law as it regarded the involuntary removal standard. under the guise of maintaining and improving public safety, the directive explicitly enables patrol officers “to take into custody, for the purpose of a psychiatric evaluation, an individual who appears to be mentally ill and is conducting themselves in a manner likely to result in serious harm to self or others”118 when they apparently cannot meet their “basic human needs”. 119 the directive has been heavily criticized by homeless rights and disability rights advocates, as well as civil rights lawyers who are challenging its facially discriminatory basis in an ongoing federal court proceeding. 120 not only does its language directly contravene the new york city human rights law and the americans with disabilities act regarding disability discrimination, but it suggests that even those who have not committed an overtly dangerous act may still be subjected to forced removal and hospitalization by law enforcement. in partnership with other housing advocates across the country, the national homelessness law center called for the condemnation of this directive in extensive consultation with the united nations’ (“un”) human rights committee (“the committee”) and multiple un special rapporteurs in the fall of 2023. 121 in a detailed set of concluding observations expressing its concerns ————————————————————————————— removing law enforcement from homeless outreach, hum. nyc (last visited dec. 20, 2023), https://www.humanplan.nyc/removing-law-enforcement [https://perma.cc/9unn-3cdy]. 118. mental health involuntary removals (mhir), (nov. 28, 2022), in official website of n.y.c., office of the mayor., https://www.nyc.gov/assets/home/downloads/pdf/press-releases/ 2022/mental-health-involuntary-removals.pdf. 119. eric adams, mayor, nyc, transcript: mayor eric adams delivers address on mental health crisis in new york city and holds q-and-a, (nov. 29, 2022), https://www.nyc.gov/ office-of-the-mayor/news/871-22/transcript-mayor-eric-adams-delivers-address-mental-healthcrisis-new-york-city-holds. 120. see generally second amended class action complaint, greene v. city of new york, no. 21-cv-05762-pac (s.d.n.y. apr. 20, 2023), ecf no. 155 (detailing a class action suit on behalf of six individuals and four similarly situated organizations against the nypd and mayor eric adams regarding the removals directive) [hereinafter greene v. city of new york]; see also mayor adams’ plan will not help people with mental disabilities, nat’l. low income hous. coal. (dec. 12, 2022), https://nlihc.org/sites/default/files/nyc-statement_final_121222.pdf (containing nearly 300 organizational and individual signatories opposing the mayor’s removals directive). 121. see generally eric tars et al., criminalization of homelessness and mental health in the united states: shadow report to the united nations human rights committee for the united states’ review of the international covenant on civil and political rights, nat’l homelessness l. ctr & miami l. hum. rts. clinic (sept. 12, 2023) (detailing policy recommendations for the human rights committee to issue upon the u.s. government, while demonstrating the prevalence of the criminalization of homelessness and mental health in the u.s.) [hereinafter iccpr shadow report]; see also eric tars et al., the criminalization of homelessness and mental health in the https://nlihc.org/sites/default/files/nyc-statement_final_121222.pdf https://www.nyc.gov https://www.nyc.gov/assets/home/downloads/pdf/press-releases https://perma.cc/9unn-3cdy https://www.humanplan.nyc/removing-law-enforcement 2024] with liberty and justice for all 269 and policy recommendations to the u.s. government, the committee characterized “the disproportionate impact of homelessness on . . . persons with disabilities” as a violation, inter alia, of the right to life. 122 the center further argued that the directive is demonstrable of how de facto criminalization policies have, just the same as certain judicial precedent, created arbitrary legal standards around involuntary commitment. the directive does not address the root causes of homelessness, nor does it address the range of reasons mental health disabilities are exacerbated and so widely prevalent across populations experiencing homelessness and racial and socioeconomically marginalized communities. rather, these standards disregard the civil liberties of people with mental disabilities who experience homelessness, and their humane, basic needs, including, but not limited to, permanent supportive housing. ii. california’s care courts california’s housing affordability and homelessness crisis has reached an unsustainable threshold. between 2014 and 2020, the state’s homelessness count increased by 42%, compared to the 9% decrease in homelessness in the rest of the country.123 the department of housing and urban development (“hud”)’s most recent point-in-time (“pit”) count found that california’s 123,423 unsheltered individuals accounted for an estimated 48% of the u.s.’s unsheltered population, 124 while a related university of california-san francisco (“ucsf”) study confirmed that the state contains 30% of the u.s.’s total homeless population. 125 furthermore, the vastly high prevalence of mental illness amongst californians experiencing homelessness has been a hotly contested issue in discussions about homelessness’s causes and consequences. ————————————————————————————— united states: submission to the special rapporteur on extreme poverty and human rights and the special rapporteur on the right to adequate housing, nat’l homelessness l. ctr. & miami l. hum. rts. clinic (sept. 19, 2023); see also eric tars et al., racial injustice in homelessness and housing in the united states: submission to the special rapporteur on contemporary forms of racism, racial discrimination, xenophobia and related intolerance, nat’l homelessness l. ctr. & miami l. hum. rts. clinic (oct. 6, 2023). 122. hum. rts. comm. concluding observations on the fifth periodic report of the united states of america, ¶ 40, u.n. doc. ccpr/c/usa/co/5 (dec. 7, 2023) [hereinafter 2023 iccpr concluding observations]. 123. jialu l streeter, homelessness in california: causes and policy considerations, stan. inst. for econ. pol’y rsch. (may 2022) , https://siepr.stanford.edu/publications/policybrief/homelessness-california-causes-and-policy-considerations#:~:text=california%e2%80% 99s%20homeless%20crisis%20is%20associated%20with%20high%20housing,the%20regulatio ns%20that%20have%20hindered%20new%20housing%20development [https://perma.cc/uu 2x-jatu] [hereinafter homelessness in california]. 124. 2023 ahar: part 1 – pit estimates of homelessness in the u.s., off. pol’y dev. & rsch. (dec. 2023), https://www.huduser.gov/portal/sites/default/files/pdf/2023-ahar-part1.pdf [https://perma.cc/xfv7-ql8c] (linking to 2007-2023 pit estimates by state). 125. victoria colliver, “california statewide study investigates causes and impacts of homelessness,” ucsf (june 20, 2023), https://www.ucsf.edu/news/2023/06/425646/californiastatewide-study-investigates-causes-and-impacts-homelessness [https://perma.cc/wmt2-gf58]. https://perma.cc/wmt2-gf58 https://www.ucsf.edu/news/2023/06/425646/california https://perma.cc/xfv7-ql8c https://www.huduser.gov/portal/sites/default/files/pdf/2023-ahar-part https://perma.cc/uu https://siepr.stanford.edu/publications/policy indiana health law review [vol. 21:249 270 an individual’s mental health conditions, perpetuated by multiple stress factors (i.e., loss of employment, inability to pay rent, physical health challenges, etc.) and often resulting in hospitalizations predict future homelessness—but these conditions are products of structural circumstances and policy failures rather than an individual’s voluntary choice or alleged personal failings. a total of 7% of all ucsf survey participants reported mental health hospitalization in the six months prior to homelessness. 126 about 25% of all los angeles county adults experiencing homelessness were found to have at least one serious mental illness in 2020, 127 compared to the estimated 25% of the state’s homeless population with a serious mental illness in 2023. 128 described as an “experiment . . . [of] coercive compassion,”129 governor gavin newsom signed the california community assistance, recovery and empowerment (“care”) act in 2022 to invoke civil courts’ authority in mandating involuntary commitments. 130 the care act incorporates the lps act and existing statutory provisions regarding assisted outpatient treatment programs (“laura’s law”). 131 however, it signals an expansion of state power and the unchecked pseudo-legislative function of courts, while also enabling practically anyone, including law enforcement, to petition for a commitment process. 132 rather than codifying the strict legal standards for involuntary commitments borne out of o’connor and its progeny, the care act requires an initial showing that an individual’s serious mental illness is “substantially deteriorating” or that such deterioration “would be likely to result in grave disability or serious harm to the person or others.”133 moreover, this showing may be conducted in abstentia of the individual at issue, thus implicating a lack ————————————————————————————— 126. margot kushel & tiana moore, toward a new understanding: the california statewide study of people experiencing homelessness ucsf 1, 43 (june 2023), https://homelessness.ucsf.edu/sites/default/files/2023-06/caspeh_report_62023.pdf [https://perma.cc/kja6-xhzk]. 127. see greater los angeles homeless count suggests pandemic-era policies prevented surge in homelessness, cty. l.a. homeless initiative (sept. 8, 2022), https://homeless. lacounty.gov/news/2022-homeless-count-results/ [https://perma.cc/a4vb-yxz9]. 128. scott wilson, “california shifts to an experiment in coercion to treat the homeless,” wash. post (apr. 27, 2023, 12:22pm est), https://www.washingtonpost.com/nation/023/ 04/27/california-homeless-mental-illness-newsom/ [https://perma.cc/8fwj-pzv3]. 129. id. 130. see generally s.b. 1338, 2021-2022 reg. sess. (cal. 2022) (authorizing adults to petition a civil court to create a voluntary or court-ordered care plan and implement services to “provide behavioral health care . . . to adults who are experiencing a severe mental illness . . . and who meet other specified criteria”) [hereinafter care act]. 131. see generally a.b. 1421, 2001-2002 reg. sess. (cal. 2002) (establishing an assisted outpatient treatment program for anyone suffering from a mental disorder so long as they meet certain criteria) (amended by s.b. 507, 2021-2022 reg. sess. (cal. 2021)) [hereinafter laura’s law]; see also assisted outpatient treatment, dhcs (accessed dec. 13, 2023), https:// www.dhcs.ca.gov/formsandpubs/pages/assisted-outpatient-treatment-program.aspx [https:// perma.cc/3lum-s8au]. 132. see care act, supra note 130, § 5974(f). 133. see care act, supra note 130, § 5972(d). https://www.dhcs.ca.gov/formsandpubs/pages/assisted-outpatient-treatment-program.aspx https://perma.cc/8fwj-pzv3 https://www.washingtonpost.com/nation/023 https://perma.cc/a4vb-yxz9 https://lacounty.gov/news/2022-homeless-count-results https://homeless https://perma.cc/kja6-xhzk https://homelessness.ucsf.edu/sites/default/files/2023-06/caspeh_report_62023.pdf 2024] with liberty and justice for all 271 of procedural due process that would otherwise afford them the right to rebut the “likely to” standard. the standard is vague, inviting arbitrary court speculation with the risk of basing itself on biased conceptions of an individual’s poverty. the care program is also inherently coercive. if an individual qualifies for it after a clinical assessment, they risk jail time or conservatorship if they do not participate or try to exit the program. 134 noncompliance might also subject an individual to a more permanent conservatorship, “which can include locked placements and forcible psychotropic medication for an extended—and potentially unlimited—duration.”135 it is troubling how care program participation is statutorily considered “the least restrictive alternative necessary” for ensuring the individual’s recovery and stability.136 for example, while one measurable outcome for assessing its effectiveness includes “reductions in law enforcement encounters and incarceration,”137 law enforcement and others who may not serve in the individual’s best interest can still subject them to a court process in violation of their due process rights. as was discussed in the context of new york city’s directive, law enforcement’s role as first responders for people experiencing homelessness often escalates times of crisis. their coercive authority over people with mental disabilities “only nods to the deeper problems causing homelessness, mental health crises, and violence.”138 and, in the absence of supportive housing and other humane treatment plans intended to safeguard the liberties of people with mental disabilities who experience homelessness, the path to recovery and stability is bleak. disability rights advocates have challenged the care act’s legal validity,139 while the un human rights committee has called for the “redirecting [of] funding from criminal justice responses towards adequate housing and shelter programmes.”140 the committee recognizes that enhanced police budgeting at the cost of state-funded homelessness programs destabilizes ————————————————————————————— 134. “disability rights california & advocates urge assembly health committee to vote no on sb1338: joint letter in opposition to care court,” disability rts. cali. (june 22, 2022), https://www.disabilityrightsca.org/latest-news/disability-rights-california-advocates-urgeassembly-health-committee-to-vote-no-on-sb [https://perma.cc/z47g-83d9] (noting, also, that conservatorships deprive people of “the right to choose where to reside, to make medical decisions, to vote, [etc.]” and, thus, perpetuate institutional racism and health disparities). 135. iccpr shadow report, supra note 121, ¶ 33. 136. care act, supra note 130, § 5972(e). 137. care act, supra note 130, § 5985(e)(17). 138. beth haroules & simon mccormack, we can’t police our way out of homelessness and mental health crises, nyclu (mar. 24, 2022, 12:15pm), https://rightsandrecovery.org/enews-bulletins/2022/3/24/nyclu-we-cant-police-or-coerce-our-way-out-of-homelessness-andmental-health-crises/ [https://perma.cc/vny5-npez]. 139. disability rights california, disability rights advocates file petition challenging the constitutional validity of the care act, press release (jan. 26, 2023), https://www.disabilityrightsca.org/press-release/disability-rights-advocates-file-petitionchallenging-the-constitutional-validity-of [https://perma.cc/m5nc-3n5j]. 140. 2023 iccpr concluding observations, supra note 122, ¶ 41. https://perma.cc/m5nc-3n5j https://www.disabilityrightsca.org/press-release/disability-rights-advocates-file-petition https://perma.cc/vny5-npez https://rightsandrecovery.org/e https://perma.cc/z47g-83d9 https://www.disabilityrightsca.org/latest-news/disability-rights-california-advocates-urge indiana health law review [vol. 21:249 272 the lives of people experiencing homelessness and criminalizes them in violation of international human rights standards. accordingly, as the courtsanctioned process and care act mechanism is inarguably coercive, it is no extension of compassion. despite what care stands for, this legislation removes people from their community, disempowers them, fails to assist them, and is unlikely to lead to recovery. iv. policy recommendations: re-imagining justice while “justice” was inscribed in the preamble of our federal constitution, the framers (arguably) did not contemplate how america’s colonialist legacies and conditions of poverty, inequitable wealth distribution, and racial capitalism would impede its actualization. in the 200th anniversary of the document’s founding, then-supreme court justice thurgood marshall voiced that the framers’ vision was “defective from the start” and that while there were “eloquent objections” to slavery raised by several of them, the document “laid a foundation for the tragic events that were to follow.”141 justice marshall was right. the experiences of many members of today’s judiciary, confined within elite social establishments, guard them from the realities of oppression and marginalization. the same can be said of the mostly white men in congressional halls, governors’ mansions, city halls, and city council chambers. this, among other reasons, is how and why systems of law and policy were built for maintaining power for few, rather than administering justice for all, and why society must re-imagine each system if it wants to decriminalize homelessness and mental health and enforce universal human rights like the right to adequate housing. a. adopting an international human rights framework the un special rapporteur on adequate housing condemned homelessness as “perhaps the most visible and most severe symptom of the lack of respect for adequate housing.”142 according to the un committee on economic, social and cultural rights, adequate housing is the right to live in “security, peace, and dignity.”143 adequate housing demands more than just four walls and a roof. at ————————————————————————————— 141. david g. savage, marshall on constitution: ‘defective from start’, l.a. times, may 7, 1987, https://www.latimes.com/archives/la-xpm-1987-05-07-mn-4540-story.html [https:// perma.cc/9ynt-r3z2]. 142. u.n. off. high comm’r for hum. rts., the human right to adequate housing: fact sheet no. 21/rev.1 21 (2009), https://www.ohchr.org/sites/default/files/documents/ publications/fs21_rev_1_housing_en.pdf [https://perma.cc/wu88-gjap]. 143. id., at 3. https://perma.cc/wu88-gjap https://www.ohchr.org/sites/default/files/documents https://www.latimes.com/archives/la-xpm-1987-05-07-mn-4540-story.html 2024] with liberty and justice for all 273 least seven key dimensions 144 must be met before housing can be considered “adequate” under the international human rights framework: security of tenure, availability of services, materials, facilities and infrastructure, affordability, 145 habitability,146 accessibility,147 location,148 and cultural adequacy. “in the [international] human rights framework, every right creates a corresponding duty on the part of the government to respect, protect, and fulfill the right.”149 contrary to the propaganda of its opponents, the right to adequate housing does not require the government to build free houses for every person. it does, however, ascribe ultimate responsibility to the government to act in utility of its “maximum available resources.”150 accordingly, it creates an affirmative governmental obligation to expeditiously implement a plan for housing people without a home. 151 most importantly, we must transform our views of housing as a privatized commodity, primarily accessible to the wealthy, and adopt the core central belief that housing is a universal human right, not a privilege. this requires honoring the principles enshrined in our international human rights commitments, ensuring that they are appropriately and effectively utilized as a tool of governance and accountability. ————————————————————————————— 144. see u.n. off. high comm’r for hum. rts., cescr general comment no. 4: the right to adequate housing (art. 11(1) of the covenant), u.n. doc. e/1992/23 (dec. 13, 1991) [hereinafter general comment no. 4]. 145. see jennifer ludden, housing is now unaffordable for a record half of all u.s. renters, npr (jan. 25, 2024), https://www.npr.org/2024/01/25/1225957874/housingunaffordable-for-record-half-all-u-s-renters-study-finds [https://perma.cc/3mf6-l9dv] (quoting jeff olivet, executive director of the u.s. interagency council on homelessness: “we simply don’t have enough homes people can afford.”). 146. see general comment no. 4, supra note 144, § 8(d) (explaining how habitable housing guarantees physical safety, adequate space, and protection against cold, damp, heat, rain, wind, other health and structural hazards threats); see, e.g., anita snow, sweltering streets: hundreds of homeless die in extreme heat, ap (june 24, 2022, 1:35pm est), https://apnews.com/article/ climate-science-health-and-environment-4f23d928ea637d239147c0e4adbad6dc [https://perma.cc/c7zt-fbvd] (discussing how phoenix, arizona’s excessive heat wave and uninhabitable conditions caused 130 people experiencing homelessness to die in 2021). 147. see general comment no. 4, supra note 144, § 8(e) (discussing how accessible housing must consider and meet the specific needs of disadvantaged and marginalized groups—especially those with physical and mental health disabilities). 148. see general comment no. 4, supra note 144, § 8(f) (discussing how housing should be close to employment opportunities, health-care amenities, schools, childcare centers, and other social establishments, and in a clean environment without pollution and other dangers in the area). 149. see eric tars, housing as a human right, nat’l low income hous. coal. 2018 advocates’ guide 1-13 (2018). 150. id. 151. see all in: the federal strategic plan to prevent and end homelessness, u.s. interagency council homelessness (usich), (2022), https://www.usich.gov/sites/default/ files/document/all_in.pdf (expressing the need to expand housing stock availability, but neither defining nor providing criteria for what constitutes adequate housing). https://www.usich.gov/sites/default https://perma.cc/c7zt-fbvd https://apnews.com/article https://perma.cc/3mf6-l9dv https://www.npr.org/2024/01/25/1225957874/housing indiana health law review [vol. 21:249 274 b. adopting a poverty abolitionist framework we often think about abolitionism as tearing down systems of power, creating and envisioning a world without harm. but abolitionism, at its core, is about healing, restorative transformation, and love—the kind of love that views others as an extension of self. practicing it requires completely shifting our conceptions of systemic reform. to decriminalize homelessness and mental health, we must first intentionally center disability justice and dismantle ableism because “carceral systems medicalize, pathologize, criminalize, and commodify survival, divergence, and resistance.”152 people with disabilities comprise 26% of the country’s population, yet are over-represented across all carceral populations and across all civil commitment “treatment” facilities, nursing facilities, and “hospitals”. 153 many of these facilities operate under the false pretense of providing care and wrap-around support services. the rise of civil involuntary commitment schemes are explicit examples of how the judicial system and police forces are deliberately evaluating an individual’s “qualifications” for treatment based on perceived, subjective divergences. they also perpetuate ableism, “a systemic oppression that allows social systems, and individuals to assign value to people based on their appearance and their ability to re/produce, excel, and behave” among other things. 154 second, we must acknowledge our society’s reliance on the criminal legal system by way of surveillance tactics, the policing of people experiencing homelessness, the denial of their civil liberties, and their further economic deprivation. this reliance completely disregards the extent of how mental, emotional, and psychological trauma often worsen because of oppressive carceral conditions. as eleanor bumpers’ tragedy demonstrates, their contact may even result in a killing. 155 this overtly biased and racist policing serves the opposite purpose of compassionate crisis intervention. accordingly, creating a world that decriminalizes homelessness and mental health, among other conditions of poverty, must attack the various tiers of oppression and demand a transformation shift, abolition of court structures, and shrinkage of the carceral state’s footprint. this includes pressuring our elected officials to divest funding from carceral responses toward homelessness, and repeal punitive, criminalization laws and policies that expand police authority. ————————————————————————————— 152. talila lewis, disability justice is an essential part of abolishing police & ending incarceration, abolition for the people: the movement for a future without policing & prisons 60, 62 (colin kaepernick ed., 2021). 153. id. 154. id. at 61. 155. see supra. sec. iii.b.i.; see also advancing an alternative to police: community-based services for black people with mental illness, legal defense fund & bazelon ctr. mental health l. 1-9 (2022) (narrating the tragic accounts of natasha mckenna, saheed vassell, and daniel prude to demonstrate how the racially biased and discriminatory treatment of black people with mental disabilities have resulted in countless senseless killings by law enforcement). 2024] with liberty and justice for all 275 these officials—i.e., governors, mayors, and judges—can (and should) “take the lead from organizers [and persons with lived expertise] as ‘fellow advocates,’ pushing legal doctrine in an abolitionist direction”.156 however, even if this advocacy produced harm-reducing outcomes in the short-term, abolitionism demands a longer-term shift of hearts and minds. ultimately, all institutional legacies predicated on racial capitalism, settler colonialism, militarism, and white supremacy—the same legacies that have disproportionately criminalized and disempowered poor people of color, and those experiencing homelessness and health disparities—must be replaced by institutions anchored in fairness and justice. dismantling these social ills and their root causes is an essential step towards preserving and honoring the humanity of all individuals. v. conclusion in most cases, statistical findings interpreting decades of epidemiological and sociological research do not capture the multitude of civil consequences and systemic institutional barriers that criminalize rather than humanize people experiencing homelessness. many of these individuals, particularly those with health conditions, are victim-blamed for their own circumstances of poverty. society has stigmatized their mental health disabilities as the drivers of homelessness, labeled them as dangerous violent criminals who make communities less safe, and treated them as pariahs who are less worthy and less deserving of the most basic and essential human needs. imagine a world where the u.s. adopted a human rights framework as the model for building affordable, adequate housing. would homelessness still be on the rise? 157 imagine if jha’asryel-akquil bishop was met with a plan to be housed and healed, rather than handcuffed and forcibly hospitalized. imagine if instead of the “coercive compassion” of california’s care act or new york city’s mental health involuntary removals, there was a directive that criminalize people experiencing homelessness, our executives, legislators, and other policymakers exercised true compassion by fully embracing policies prioritizing permanent supportive housing over handcuffs. ending homelessness is not just about curbing street homelessness. nor is it about providing just any physical structure or shelter to ensure protection from the elements. rather, ending homelessness demands deliberately addressing its root causes and legacies—the historical structural racism, gender and sex-based discrimination, and ableism that not only affect one’s housing conditions, but the health of one’s body and mind. it demands a restructuring of the legal system that has failed to remedy structural inequalities, and funding vital health and ————————————————————————————— 156. id. 157. see steff danielle thomas, homelessness in us surges to highest-recorded level, the hill (dec. 15, 2023, 7:55 pm), https://thehill.com/homenews/administration/4363103homelessness-sours-highest-recorded-level/ [https://perma.cc/j9r5-66n4]. https://perma.cc/j9r5-66n4 https://thehill.com/homenews/administration/4363103 indiana health law review [vol. 21:249 276 community-based services 158 and expanding the availability of affordable housing. all of this requires accountability from our elected officials and those equipped with enforcing the law to ensure that everyone has a fundamental human right to adequate housing. getting there requires courage. courage to view our neighbors who experience homelessness as an extension of ourselves. courage to reject the loud and dehumanizing calls to sweep those neighbors from public view and into a concrete cell, a dangerous and uninhabitable congregate shelter, or on the fringes of town for “someone else” to deal with. and lastly, courage to expand our vision and reimagine a society where this is all possible. the strong will of the people can make it so. ————————————————————————————— 158. see, e.g., colleen f. shanahan & anna e. carpenter, simplified courts can’t solve inequality, 148 daedalus 128, 130 (2019) (“but are state civil courts the appropriate institution to address individual socioeconomic needs like untreated substance abuse and mental illness, domestic violence, and unstable housing that manifest in a society with stagnant wages and rising inequality?”). structure bookmarks with liberty and justice for all: the case for indiana health law review volume xix 2022 number 2 articles sperm and eggs in consideration of money: a pound of flesh for three thousand ducats? adeline a. allen* donor conception is a practice in which a donor sperm or egg (or both) is used to conceive a child. usually, the donor sperm or egg is procured in a financial transaction: gametes exchanging hands for money. the “donor” in donor conception is a bit of an oxymoron, for a donation it is not when money—and sometimes big money—is a feature of the practice, not a bug. this article will show that donor conception is not proper to who human beings are given their nature as embodied beings, with particular attention to the children of donor conception and to the donors. the bargained-for exchange of sperm and eggs for money also does not satisfy the requirement of commutative justice, historically understood to be of paramount importance in the doctrine of consideration in contract law. further, the aspects of both the embodied nature of the person and the impropriety of trading on the body present in donor conception are considered in light of william shakespeare’s play the merchant of venice. this article concludes that donor conception, being unjust and not oriented to human flourishing, ought not to be done. a re-orientation of the law toward a proper respect for each person’s embodied nature and toward fostering a posture of gratitude in receiving each child as a gift would be welcome. i. introduction eli baden-lasar has thirty-two half siblings, perhaps more.1 he was conceived using the sperm of a donor, and as he grew up, he became curious about any half siblings out there.2 he went on a quest to find as many half siblings as he could, and when he found them, he met with them and took * associate professor of law, trinity law school. i thank melissa moschella, ana samuel, c. scott pryor, charles t. rubin, andrew r. deloach, the shakespeare reading group at trinity law school, kathryn francisco, and james j. duane for their various help. the positions taken in this article and any errors or omissions are mine alone. 1. eli baden-lasar, a family portrait: brothers, sisters, strangers, n.y. times (june 26, 2019), https://www.nytimes.com/interactive/2019/06/26/magazine/sperm-donor-siblings.html [https://perma.cc/l9b3-4zlu]. as of 2019, he has taken photographs of thirty-two of his half siblings. id. 2. id. 276 indiana health law review [vol. 19:275 photographs of them.3 one day, he and three half siblings were huddled together, listening to a recording of the voice of their father from long ago. their father was speaking to the sperm bank that collected his sperm.4 in baden-lasar’s words: the bank asks the donor at the end of the audio interview whether he has anything he would like to tell any children conceived with his sperm. our donor’s response: “i wish them all the luck.” one sibling scribbled that on his bedroom wall during high school in colorful chalk as if it were an inspirational quote. i heard it more as an irreverent provocation: my job here is done. may the odds be ever in your favor.5 this article explores “the odds” of the children of donor conception, given the nature of the practice. part i of this article lays out the practice of donor conception and the greater fertility industry of which it is a part. part ii briefly sketches the historical context of commutative justice and its relationship with the doctrine of consideration in contract law. part iii considers the practice of donor conception from the perspective of the child’s resulting genealogical bewilderment, the commodification of the child, and the health risks involved in the practice for the child and the egg donor. it also considers some counterarguments to the position taken in the article. part iv considers how william shakespeare’s play the merchant of venice, with its story of the bargain of a pound of flesh for a sum of money, might shed light on the practice of donor conception. this article will show that donor conception is not proper to who human beings are given their nature as embodied beings, with particular attention to the children of donor conception and to the donors. the bargained-for exchange of sperm and eggs for money also does not satisfy the requirement of commutative justice, historically understood to be of paramount importance in the doctrine of consideration in contract law. the aspects of both the embodied nature of the person and the impropriety of trading on the body present in donor conception are illuminated in the lessons of the merchant of venice. this article concludes that donor conception, being unjust and not oriented to human flourishing, ought not to be done. a re-orientation of the law toward a proper respect for each person’s embodied nature and toward fostering a posture of gratitude in receiving each child as a gift would be welcome. 3. id. 4. id. 5. id. eli baden-lasar’s take on the meaning of their father’s comment to his children (“may the odds be ever in your favor”) comes from the hunger games trilogy, a series of dystopian novels that tells of a society that sacrifices children in bloody, fatal games. the children are sacrificed in the games for the sake of, among other things, the enjoyment of the people: the games are popular, and it’s what the people want. see the hunger games, suzanne collins (2008); catching fire, suzanne collins (2009); mockingjay, suzanne collins (2010). 2022] sperm and eggs in consideration of money 277 ii. the practice of donor conception to borrow from leon r. kass, if the reader will pardon the impropriety, i will not beat around the bush: the subject is sperm and eggs, the goal is making babies, the question is, “to market or not to market?”6 donor conception is a practice in which a donor sperm or egg (or both) is used to conceive a child. usually, the donor sperm or egg is procured in a financial transaction: gametes exchanging hands for money. the cast of characters in donor conception are the sellers of the gametes, the buyers of those gametes, and—out of the transaction—the resulting children. the term “donor conception” masks the sale involved: buyers pay the sperm “donor” for his sperm and the egg “donor” for her eggs.7 perhaps the masking is not unintentional. the term “donor” softens the impact on the hearer.8 for the buyers in this market buy sperm and eggs not for the sake of buying sperm and eggs, but for the sake of having children.9 the fertility industry, estimated as a $33.1 billion industry globally in 2020,10 6. the original quote is, “if the reader will pardon the impropriety, i will not beat around the bush: the subject is human flesh, the goal is the saving of life, the question is, ‘to market or not to market?’” leon r. kass, organs for sale? propriety, property, and the price of progress, nat’l aff. 65, 65 (june 11, 1991), https://www.nationalaffairs.com/storage/app/uploads/public/58e/1a5/ 0fb/58e1a50fb5d22479581310.pdf [https://perma.cc/k6va-67u8]; see also debora l. spar, the baby business: how money, science, and politics drive the commerce of conception xvxvi, at 195-96 (2006); kara w. swanson, banking on the body: the market in blood, milk, and sperm in modern america 225-37, 240 (2014) (exploring the market rhetoric and practice for sperm and eggs). 7. see courtney megan cahill, the new maternity, 133 harv. l. rev. 2221, 2226 (2020); henry t. greely, the end of sex and the future of human reproduction, 130 harv. l. rev. 1785, 1785 (2017); douglas nejaime, the nature of parenthood, 126 yale l. j. 2260, 2264 (2017); courtney g. joslin, nurturing parenthood through the upa (2017), yale l.j. f. 589, 599-600 (2018); spar, supra note 6, at 200-01; brenda reddix-smalls, assessing the market for human reproductive tissue alienability: why can we sell our eggs but not our livers?, 10 vand. j. ent. & tech. l. 643, 652 (2008); paris martineau, inside the quietly lucrative business of donating human eggs, wired (apr. 23, 2019, 7:00 am), https://www.wired.com/story/insidelucrative-business-donating-human-eggs/ [https://perma.cc/vun2-e8rx]. 8. see spar, supra note 6, at 6; swanson, supra note 6, at 4-8, 205. consider, for example, the oxymoron in the following gamete donation advertisement: “get paid [t]o donate?” sonia f. epstein & polina n. whitehouse, inheriting the ivy league: the market for educated egg and sperm donors, harv. crimson (apr. 30, 2020), https://www.thecrimson.com/article/2020/4/30/ inheriting-the-ivy-league/ [https://perma.cc/8dd4-nxl7]; see melissa moschella, reproductive technologies and human dignity, pub. discourse (nov. 17, 2019), https://www. thepublic discourse.com/2019/11/57961/ [https://perma.cc/qp2g-gj5h]. 9. see spar, supra note 6, at xv-xvi, 3, 195-96. 10. fertility market size to hit around us$ 47.9 billion by 2030, globenewswire (feb. 10, 2021, 10:46 am), https://www.globenewswire.com/news-release/2021/02/10/2173389/0/en/ fertility-market-size-to-hit-around-us-47-9-billion-by-2030.html [https://perma.cc/r2r3-hpj2]. 278 indiana health law review [vol. 19:275 markets to both buyers and sellers of gametes.11 the buyers are would-be parents, be they couples, singles, or those in some other arrangements12 who need a sperm, egg, or both, to have a baby through in-vitro fertilization (“ivf”).13 the process is involved and not cheap, so it is not for the faint of heart—or for the poor.14 the fertility industry markets to potential sellers too, targeting students and professionals15 who would make for young16 and healthy17 gamete donors (bonus points for smart, accomplished, and attractive18). college campuses are lucrative markets.19 california cryobank, for example, a leading sperm-and-egg bank in the country,20 has locations within walking distances of or near harvard university, mit, stanford university, nyu, and ucla.21 college students routinely find 11. michele goodwin, introduction, in the global body market: altruism’s limits xvii, xix (michele goodwin ed., 2014); o. carter snead, what it means to be human: the case for the body in public bioethics 188-89 (2020); spar, supra note 6, at 37, 39. 12. see ian jenkins, three dads and a baby: adventures in modern parenting (2021); spar, supra note 6, at 1-6; ian jenkins, our poly family legal battle: answering faqs, psych. today (mar. 1, 2021), https://www.psychologytoday.com/us/blog/better-or-worse/202103/ our-poly-family-legal-battle-answering-faqs [https://perma.cc/d75s-wtzh]; single mothers by choice, fairfax cryobank, https://fairfaxcryobank.com/single-mothers [https://perma.cc/8kh9m22z] (last visited apr. 14, 2022); brett wilkins, mass. lesbian ‘throuple’ expecting first child, dig. j. (apr. 24, 2014), http://www.digitaljournal.com/life/lifestyle/mass-lesbian-throupleexpecting-first-child/article/381913 [https://perma.cc/rq5g-clzr]. 13. see snead, supra note 11, at 186-200; spar, supra note 6, at 31-67. 14. see, e.g., egg donor fees at west coast egg donation, w. coast egg donation, https://www.westcoasteggdonation.com/egg-donor-program/costs-fees [https://perma.cc/f6xttyv5] (last visited apr. 14, 2022); samantha fields, the cost of building a family using donor sperm, marketplace (oct. 24, 2019), https://www.marketplace.org/2019/10/24/the-cost-ofbuilding-a-family-using-donor-sperm/ [https://perma.cc/vl86-h5ac]; frozen donor egg cycle cost at the advanced fertility center of chicago, advanced fertility ctr. chi., https:// advancedfertility.com/fert ility-treatment/affording-care/frozen-donor-eggs-cost / [https://perma.cc/g8cd-u4j2] (last visited apr. 14, 2022); rachel gurevich, how much does ivf really cost?, verywell fam., https://www.verywellfamily.com/how-much-does-ivf-cost1960212 [https://perma.cc/7vpy-g3xx] (last updated nov. 27, 2021); sharon mazel, using a donor egg to get pregnant, what to expect (mar. 29, 2019), https://www.whattoexpect.com/ getting-pregnant/fertility-tests-and-treatments/donor-egg/ [https://perma.cc/jqs5-pyzs]. 15. spar, supra note 6, at 37. 16. richard a. epstein, how to create markets in contestable commodities, in the global body market: altruism’s limits 44, 60 (michele goodwin ed., 2014). 17. spar, supra note 6, at 37. 18. id. at x, xi, 37, 81; see swanson, supra note 6, at 230-33. 19. spar, supra note 6, at 39; swanson, supra note 6, at 198-99. 20. press release, california cryobank, california cryobank offers world’s largest sperm/egg donor catalog (feb. 21, 2018), https://www.cryobank.com/about-us/press-releases/ california-cryobank-offers-world-s-largest-sperm/egg-donor-catalog/ [https://perma.cc/j2ltbxue]. 21. see branch laboratories, cal. cryobank, https://www.cryobank.com/about-us/ 2022] sperm and eggs in consideration of money 279 advertisements by sperm and egg banks in their campus newspapers, with a noble call to help would-be parents in exchange for payment.22 payment to sperm donors is about $75 per specimen23 and to egg donors ranging from $2,500 to $50,000, depending on the donor’s “qualifications.”24 (one ad promised payment of $100,000.25) so-called “ivy eggs,” eggs from a woman with an ivy league college on the résumé, have commanded $50,000.26 buyers, on their part, choose the sperm or egg with desired characteristics and qualifications27 out of the website catalogue:28 clean family medical history?29 height of at least 5’9”?30 blond(e) hair?31 jewish?32 asian?33 indian?34 white?35 sat score of at least locations/ [https://perma.cc/2wzg-ubt6] (last visited apr. 14, 2022); see also epstein, supra note 16, at 60. 22. egg donor wanted, “b” students need not apply, stan. daily (may 30, 2012, 12:05 am), https://www.stanforddaily.com/2012/05/30/egg-donor-wanted-b-students-need-not-apply/ [https://perma.cc/nwy4-94pl]; elitist and racist egg donation ads have no place in student newspapers, tech (feb. 18, 2021), https://thetech.com/2021/02/18/egg-donation-ad-editorial [https://perma.cc/3fyx-g6q6]; kat huang, egg donor ads target women of ivy league, yale daily news (mar. 22, 2005, 12:00 am), https://yaledailynews.com/blog/2005/03/22/egg-donorads-target-women-of-ivy-league/ [https://perma.cc/z69z-edjc]; rachel p. kovner, egg-seeking ad draws nearly 30 harvard applicants, harv. crimson (july 2, 1999), https://www. thecrimson.com/article/1999/7/2/egg-seeking-ad-draws-nearly-30-harvard/ [https://perma.cc/6pfp9n9t]; divya subrahmanyam, ‘ivy league egg donor wanted,’ yale daily news (apr. 23, 2008, 12:00 am), https://yaledailynews.com/blog/2008/04/23/ivy-league-egg-donor-wanted/ [https://perma.cc/bn9w-uu5q]. 23. spar, supra note 6, at 39. 24. id. at x, xi, 46, 81; see swanson, supra note 6, at 230-33. 25. spar, supra note 6, at 46. 26. id. at 64, 81; susan weidman schneider, jewish woman’s eggs, lilith (sept. 19, 2001), https://lilith.org/articles/debut-57/ [https://perma.cc/p5j4-txvr]. 27. epstein, supra note 16, at 60; snead, supra note 11, at 189; spar, supra note 6, at x; swanson, supra note 6, at 229. 28. swanson, supra note 6, at 2-3. 29. spar, supra note 6, at 46; epstein & whitehouse, supra note 8. 30. donna dickenson, exploitation and choice in the global egg trade: emotive terminology or necessary critique?, in the global body market: altruism’s limits 21, 3738 (michele goodwin ed., 2014); swanson, supra note 6, at 232. 31. from a real advertisement in a 1999 college newspaper, cited in andrew wancata, note, no value for a pound of flesh: extending market-inalienability of the human body, 18 j. l. & health 199, 200 n.4 (2003); epstein & whitehouse, supra note 8. 32. helen m. alvaré, the case for regulating collaborative reproduction: a children’s rights perspective, 40 harv. j. legis. 1, 13 (2003); epstein & whitehouse, supra note 8; martineau, supra note 7. 33. alvaré, supra note 32, at 13; epstein & whitehouse, supra note 8; martineau, supra note 7. 34. epstein & whitehouse, supra note 8; martineau, supra note 7. 35. spar, supra note 6, at 46; michele goodwin, the body market: race politics & private 280 indiana health law review [vol. 19:275 1400?36 plays the cello?37 does modeling and calligraphy on the side?38 or even . . . nobel prize winners and olympic athletes?39 the popular view is that donor conception, the practice of which involves paying the donor for the gametes, is fine.40 the thriving fertility industry includes a robust market for sperm and eggs, a market that exists to produce babies—“the baby business,” dubbed debora l. spar.41 so the market at this point seems to be taken for granted,42 which is to say, that the acceptability of the buying and selling of human gametes seems to be similarly settled. certainly the buyers of the gametes have often walked a long road of infertility’s sorrow, and the aching longing for children is deep and heartbreaking.43 and certainly the sellers are often motivated by altruism in their desire to help those who want to have children by providing the requisite gametes, even if at the same time the payment is important to them.44 but if the bargained-for exchange is gametes for money, how does that consideration satisfy the requirement of commutative justice, historically an important principle in contract law? and what does donor conception entail, particularly from the perspectives of the resulting children and from the egg donors? iii. commutative justice and consideration aristotle and aquinas thought of contract-making as an exercise of moral virtue, with one such important virtue being commutative justice.45 commutative ordering, 49 ariz. l. rev. 599, 608 (2007). 36. dickenson, supra note 30, at 37-38; spar, supra note 6, at 46. 37. dickenson, supra note 30, at 37-38; spar, supra note 6, at 81. 38. see wesley j. smith, a right to the baby we want, first things (oct. 27, 2017), h t tps:/ /www.first th ings.com/web-exclusives/2017/10/a-right-to-the-baby-we-want [https://perma.cc/65ky-caj8]. 39. spar, supra note 6, at 37. the sperm bank that marketed the sperm of nobel prize winners closed in 1999, and as it turned out had carried the sperm of only three nobel laureates, which in turn did not fertilize any eggs. snead, supra note 11, at 189. 40. melissa moschella, rethinking the moral permissibility of gamete donation, 35 theoretical med. & bioethics 421, 422 (2014). 41. spar, supra note 6, at xvii. 42. id. 43. see spar, supra note 6, at 31-46; see, e.g., stories from our donor egg families, donor egg bank usa, https://donoreggbankusa.com/success-rates/testimonials [https://perma.cc/u625965c] (last visited apr. 14, 2022); i used an egg donor, parents (sept. 10, 2018), https:// w w w .paren t s . com/ge t t in g-pregn an t / t ryin g-to -con ce ive / i-u sed-an -egg-don or / [https://perma.cc/9qpt-x2fs]; sarah kowalski, the truth about infertility for women over 40, harper’s bazaar (feb. 21, 2018), https://www.harpersbazaar.com/culture/features/a15943359/ egg-donor-infertility-ivf/ [https://perma.cc/mv76-vnvl]. 44. see spar, supra note 6, at xi; swanson, supra note 6, at 198-99. 45. james gordley, the philosophical origins of modern contract doctrine 7, 1012 (2011) [hereinafter gordley, origins]; see also james gordley, the jurists: a critical 2022] sperm and eggs in consideration of money 281 justice requires that “in an exchange, the value of what each party gives should equal that of what he receives, thereby preserving each party’s share of purchasing power.”46 in other words, commutative justice is about meeting the requirement of roughly equal values being exchanged47 that neither party be unjustly enriched at the other’s expense.48 if the telos or end of law is the common good49 and the common good requires justice, then the telos of justice, commutative justice included, is flourishing, a life of virtue.50 law, then, inescapably deals with morality, as morality is but “another name for a fully reasonable concern for human flourishing in all its basic aspects, integrally considered,” john finnis writes.51 commutative justice was part of the bedrock of contract law for over half a millennium in the western legal thought.52 being the beneficiary of jurists following the late scholastic, humanist, and modern jurists53 who have dropped certain aspects of the aristotelian–thomistic understanding of law and commutative justice in contracting, which has resulted in a rather incoherent theory of contracts, we would do well to go back to the roots of contract law in our jurisprudence54—natural law’s understanding of fairness and its relationship to justice and flourishing. history 109 (2013) [hereinafter gordley, jurists]. 46. james gordley, foundations of private law: property, tort, contract, unjust enrichment 404 (2007) [hereinafter gordley, foundations]. 47. see mary l. hirschfeld, aquinas and the market: toward a humane economy 134 (2018); gordley, foundations, supra note 46, at 361; gordley, jurists, supra note 45, at 93-95; gordley, origins, supra note 45, at 13-14; c. scott pryor, revisiting unconscionability: reciprocity and justice, in christianity and private law 178, 179 (robert f. cochran, jr. & michael p. moreland eds., 2021). 48. gordley, foundations, supra note 46, at 287, 404; gordley, jurists, supra note 45, at 84; gordley, origins, supra note 45, at 55. 49. thomas aquinas, summa theologiae (i-ii, q.96, a.1). 50. see john finnis, aquinas and natural law jurisprudence, in the cambridge companion to natural law jurisprudence 17, 19, 24, 34, 38, 41, 46, 51, 53 (george duke & robert p. george eds., 2017); john finnis, natural law & natural rights 161 (1980); gordley, jurists, supra note 45, at 84, 107, 110; gordley, origins, supra note 45, at 19-20, 22-23, 244-48; see also christopher tollefsen, natural law, basic goods and practical reason, in the cambridge companion to natural law jurisprudence, supra, at 133, 156. 51. john finnis, the nature of law, in the cambridge companion to the philosophy of law 38, 47 (john tasioulas ed., 2020); see also 1 john finnis, commensuration and public reason, in reason in action 233, 243 (2013); finnis, supra note 50, at 19-20; robert p. george, natural law, god and human dignity, in the cambridge companion to natural law jurisprudence, supra note 50, at 59; tollefsen, supra note 50, at 151, 153. 52. pryor, supra note 47, at 179. 53. gordley, foundations, supra note 46, at 287-88; gordley, jurists, supra note 45, at 109-10. 54. see gordley, origins, supra note 45, at 7-9, 230, 232. 282 indiana health law review [vol. 19:275 historically, “causa,” or latin for “reason,”55 also often understood as motive,56 has evolved into consideration, which has since modernly evolved, or perhaps better stated “redesigned,” into the concept of bargained-for exchange.57 despite the similarities, different understandings and sensibilities informed each doctrine’s development and definition. commutative justice is no longer an important principle in the modern doctrine of consideration as bargained-for exchange, with, for example, the modern doctrine of consideration jettisoning the virtue of liberality or gift as a valid reason to enforce a contract.58 there went the validity of love and affection as consideration also.59 that the modern doctrine of consideration is rather incoherent as a result60 may be seen, for example, in the tortured treatment of adequacy of consideration: courts now say that they are restrained from scrutinizing the adequacy of consideration—but if the value of what is exchanged is too blatantly unequal, it is suspect as a gift or gratuitous consideration, which is not valid consideration.61 similarly, if adequacy of consideration is truly not an issue, why require a detriment be “fresh,” invalidating past consideration and moral consideration?62 of course if adequacy of consideration is truly of no issue at all, commutative justice is weakened because there would then be no requirement that the value of what is being exchanged be equal.63 and yet the doctrine of consideration shows ambivalence in committing to such a stark conception of the law, bereft of commutative justice. the incoherence evident in consideration is a result of it. causa, by contrast, recognized that contracts needed to fulfill the requirement of commutative justice,64 even if modern consideration may only give an uneasy nod to it.65 the doctrine of unconscionability, for example, is used in an answer 55. id. at 50. 56. a. w. brian simpson, a history of the common law of contract: the rise of the action of assumpsit 321, 322, 373-74 (2005); see also harold j. berman, the christian sources of general contract law, in christianity and law: an introduction 125, 134-36 (john witte, jr. & frank s. alexander eds., 2008); c. m. a. mccauliff, a historical approach to contractual ties that bind parties together, 71 fordham l. rev. 841, 850 (2002). 57. see gordley, foundations, supra note 46, at 288; gordley, jurists, supra note 45, at 210-12; gordley, origins, supra note 45, at 49. 58. gordley, origins, supra note 45, at 137-39. 59. see restatement (second) of contracts § 71 cmt. a (am. law inst. 1981). 60. gordley, foundations, supra note 46, at 288; gordley, origins, supra note 45, at 230, 236-38. 61. berman, supra note 56, at 136; gordley, origins, supra note 45, at 146-58, 171-72, 205-08, 237; see restatement (second) of contracts § 71 cmt. b, c (am. law inst. 1981). 62. gordley, origins, supra note 45, at 173, 175; james barr ames, two theories of consideration, 12 harv. l. rev. 515, 515-17 (1899); see also restatement (second) of contracts § 71 cmt. a, § 86 cmt. a (am. law inst. 1981). 63. see berman, supra note 56, at 136. 64. gordley, origins, supra note 45, at 79; see gordley, jurists, supra note 45, at 211. 65. gordley, origins, supra note 45, at 147-58. 2022] sperm and eggs in consideration of money 283 to the injustice of unequal exchange.66 also by contrast, historically, a contract of any valuable consideration is fine,67 but consideration must not have an immoral object.68 the doctrine of causa for the earlier canonists is represented by astexanus’s statement: “[e]very pact is to be kept if it be such that it can be kept without harm to the soul or the safety of the body . . . so long as it is lawful, honest, and possible.”69 but what constitutes an “immoral object” in consideration?70 what might constitute “harm to the soul” or “safety of the body”?71 this article will take up some aspects of donor conception as related to these questions and to commutative justice. iv. donor conception, considered a. genealogical bewilderment we humans are embodied beings: we are our bodies,72 not minds or souls who happen to have bodies. this is the “understanding of the human person in which the body is an essential and intrinsic aspect of personal identity, rather than a mere extrinsic instrument of the conscious, thinking willing ‘i’ or self.”73 this view, the aristotelian-thomistic hylomorphism,74 understands the human person as one of “a substantial unity of mind and body.”75 melissa moschella explains the embodiment of the child and his relationship to his parents: the parents’ combined gametes are the biological cause of their child’s existence and identity as a human organism, which in turn is the basis of that child’s overall continuity of personal identity overtime. the child is who he is because of who his parents are; to be begotten by other parents is, simply, to be someone else.76 66. berman, supra note 56, at 131-32; gordley, origins, supra note 45, at 147-58, 236; pryor, supra note 47, at 178-79; cf. the aristotelian tradition on unjust price, gordley, foundations, supra note 46, at 366. 67. 2 william blackstone, commentaries *444. 68. berman, supra note 56, at 131, 135; edward jenks, the history of the doctrine of consideration in english law 23, 75 (1892); see also simpson, supra note 56, at 317. 69. simpson, supra note 56, at 385. 70. see jenks, supra note 68, at 23. 71. simpson, supra note 56, at 385. 72. snead, supra note 11, at 3. 73. melissa moschella, to whom do children belong?: parental rights, civic education, and children’s autonomy 9 (2017); see id. at 36. 74. patrick lee & robert p. george, body-self dualism in contemporary ethics and politics 17-18, 48-49 (2008); melissa moschella, the wrongness of third-party assisted reproduction: a natural law account, 22 christian bioethics 3, 5-8 (2016). 75. moschella, supra note 73, at 36. 76. id. at 35; see also moschella, supra note 40, at 430. 284 indiana health law review [vol. 19:275 clarity with regard to our origins is needed to understand our identity, our own selves.77 it is the parents’ united gametes, carrying the genetic information from each parent, that produced the child, and so the child is dependent on the parents for both his existence and identity.78 his parents’ presence, guidance, and relationship with him is necessary for the child to make sense of his own person and identity because of the genetic relationship between them.79 loss of his genetic parents results in a genealogical bewilderment from having been separated from one’s parents.80 this makes sense only if we are not ghosts in machines, but rather embodied beings.81 aquinas says that a child “is by nature part of” his parents, as “enfolded in the care of its parents,” physically first in his mother’s womb, then also in the “spiritual womb” of the family.82 parents are, at least initially, the closest people to the child by virtue of their given genetic relationship,83 which makes their relationship one of the strongest among all human relationships.84 if so, then children and parents belong together, and genealogical bewilderment makes sense if children and parents are torn apart. there is then an inherent longing to know and be known, to love and be loved, by our parents, by those to whom we owe our existence and identity.85 children have a special need to be, and indeed the right, to be known, raised, and loved by their biological parents.86 there is a special benefit to be loved by them 77. leon r. kass, life, liberty and the defense of dignity: the challenge for bioethics 100 (2002). 78. see moschella, supra note 40, at 429, 432. 79. see moschella, supra note 73, at 28; moschella, supra note 40, at 430. 80. katy faust, why embryo adoption damages children’s rights, them before us (dec. 5, 2019), https://thembeforeus.com/why-embryo-adoption-damages-childrens-rights/ [https:// perma.cc/kvr7-vxf6]. 81. see kass, supra note 77, at 181-82; lee & george, supra note 74, at 67. 82. thomas aquinas, summa theologiae (ii-ii, q.10, a.12); moschella, supra note 73, at 25-26. 83. moschella, supra note 73, at 37. 84. moschella, supra note 40, at 430; see finnis, supra note 50, at 205-10; moschella, supra note 73, at 50-51. 85. moschella, supra note 73, at 37, 41; alvaré, supra note 32, at 48; moschella, supra note 40, at 433-34; william joseph wagner, the contractual reallocation of procreative resources and parental rights: the natural endowment critique, 41 case w. rsrv. l. rev. 1, 146 (1990). 86. see moschella, supra note 73, at 39, 41; moschella, supra note 74, at 4, 15; wagner, supra note 85, at 146; devorah goldman, gene editing and planned personhood, pub. discourse (nov. 12, 2020), https://www.thepublicdiscourse.com/2020/11/72616/ [https://perma.cc/n3lusmch]; christopher o. tollefsen, making children, unmaking families, pub. discourse (aug. 19, 2020), https://www.thepublicdiscourse.com/2020/08/70265/ [https://perma.cc/nep6-sk76]. contrasted with the argument that adults have the right to have children, see, e.g., john a. robertson, children of choice: freedom and the new reproductive technologies 16, 2022] sperm and eggs in consideration of money 285 and to be able to respond to that love.87 conversely then, to be known, raised, and loved by their biological parents are owed to the children.88 this needed love and relationship, by their very nature grounded in their unique genetic relationship, are not replaceable by other people’s loves, however grand and deep those loves may be.89 that is to say, the will of those who brought the child into existence in the case of donor conception and are now raising him may very well be accompanied by a generous and genuine love for him, and yet the child’s embodiment, with all its needs and longings, testifies against our notions of bringing forth children as if they were “unencumbered selves,” free of any “unchosen obligations,” who would be alright if they were wanted and loved enough.90 rather, the child needs the love that is that child’s biological parents’ love for him, the relationship between that child and his parents.91 this obligation of personal love and care that the parents owe to the child is non-transferable, because no one else will do; no other people bear this special relationship between biological parents and child.92 our navel and genitalia are a reminder of our ancestors before us and our children after us,93 “our bodily mark of linkage, pointing ultimately forward to our descendants,” leon r. kass says.94 but it is a physical, ever-present reminder of the pain, loss, confusion, and dissonance for those with unknown donor parents. this may be far from the minds of would-be parents who buy the gametes with the best of intentions, but from the child’s perspective as an embodied being, he is bereft not of his sperm or egg donor, but of his very father 40, 42 (1994) (“procreative liberty”); debora l. spar, free markets, free choice?, in the global body market: altruism’s limits 3, 16 (michele goodwin ed., 2014), this position focuses on children—what they need, what is owed to them, and thus their rights—as opposed to the adults, adults’ wishes, and adults’ desires. see alvaré, supra note 32, at 55. canavox, a movement dedicated to marriage and family, states the case well: “every child has a right to a mother and a father; no one has a right to a child.” what we cheer for, canavox, https://canavox.com/whatwe-cheer-for/ [https://perma.cc/tt69-25yt] (last visited apr. 14, 2022). helen m. alvaré has also argued eloquently that there is no constitutional protection to collaborative reproduction such as donor conception. alvaré, supra note 32, at 33-41. 87. moschella, supra note 40, at 433-34. 88. see moschella, supra note 74, at 11-15; alana s. newman, what are the rights of donor-conceived people?, pub. discourse (aug. 2, 2013), https://www.thepublicdiscourse.com/ 2013/08/10511/ [https://perma.cc/68be-43qe]; see also spar, supra note 86, at 19 (welcoming the dimension of the child’s right to the discussion of reproductive ethics). 89. moschella, supra note 73, at 41; moschella, supra note 40, at 425-26, 429; moschella, supra note 74, at 11-12. 90. see snead, supra note 11, at 86-87, 269-70; see also epstein & whitehouse, supra note 8. see generally snead, supra note 11, at 65-105; lee & george, supra note 74, at 149. 91. moschella, supra note 73, at 41; moschella, supra note 40, at 425-26, 433-35; moschella, supra note 74, at 11-12. 92. moschella, supra note 40, at 428-34; see also snead, supra note 11, at 232. 93. kass, supra note 77, at 182-83. 94. id. at 101. 286 indiana health law review [vol. 19:275 or mother. so from wondering whether one’s donor parent similarly has deep-set eyes, or a wide nose, or hates the taste of cilantro,95 or enjoys restoring houses,96 to deeper questions of identity and longing for closeness and relationship,97 sixtyfive percent of sperm donor-conceived children in a survey agreed with the statement that “my sperm donor is half of who i am.”98 lindsay greenawalt, for example, said, “i feel my right to know who i am and where i come from has been taken away from me.”99 said another, olivia pratten, “i think of myself as a puzzle; the only picture i have ever known is half-complete.”100 the imagery of loss, a hole, a wound, or having something missing, is a common one.101 tom ellis, submitting his dna to the uk donor link registry to look for his sperm donor father, said, “[h]e is a part of me and without him, i will never feel completely whole.”102 to the extent that the gamete donation was made anonymously, or that laws are such that finding one’s biological parent would be harder for the child, they only make things worse, not better.103 whereas “[t]he bond of natural necessity which tied sexual union to engendering children, engendering to pregnancy, pregnancy to a relationship with the child, gave us the 95. see kyle swenson, nineteen children and counting, wash. post (sept. 7, 2020, 2:15 pm), https://www.washingtonpost.com/national/sperm-donor-father-19-children/2020/09/07/97b6f 8de-ba65-11ea-8cf5-9c1b8d7f84c6_story.html [https://perma.cc/4dd7-4yzg]. 96. kathryn francisco, it’s okay to believe that the method of your conception was wrong and still give thanks for your life, them before us (jan. 21, 2020), https://thembeforeus. com/kathryn-francisco-its-okay-to-believe-that-the-method-of-your-conception-was-wrong-andstill-give-thanks-for-your-life/ [https://perma.cc/v82j-wrs8]. 97. see elizabeth marquardt et al., my daddy’s name is donor: a new study of young adults conceived through sperm donation 11-12 (2010); goldman, supra note 86; california cryobank, kids of donor 5114, youtube (may 29, 2013), https://www.youtube. com/watch?v=ppeevvkcwma [https://perma.cc/n72b-22qm]. 98. marquardt et al., supra note 97, at 5. 99. id. at 21. 100. id. 101. of course this fragmentation is a two-way street, however infrequently explored. thus, paul ramsey remarks of the donor parents, “but to be debiologized and recombined in various ways, parenthood must first be broken or removed. when the transmission of life has been debiologized, human parenthood as a created covenant of life is placed under massive assault and men and women will no longer be who they are.” paul ramsey, fabricated man: the ethics of genetic control 135 (1970); see also epstein & whitehouse, supra note 8; alana newman, i donated my eggs, and i regret it, verily, https://verilymag.com/2015/10/reproductive-healthfertility-donating-eggs [https://perma.cc/ug37-ktda] (last updated jan. 25, 2018); three things you should know about sperm “donation,” ctr. bioethics & culture network, http://www.cbc-network.org/pdfs/3_things_you_should_know_about_sperm_donationcenter_for_bioethics_and_culture.pdf [https://perma.cc/a5nk-l5db] (last visited apr. 14, 2022); see infra notes 231-38 and accompanying text. 102. marquardt et al., supra note 97, at 21. 103. see id. at 51-54. 2022] sperm and eggs in consideration of money 287 foundation of our knowledge of human relationships in this area,”104 the missing biological parent(s) and the related kin relationships and network in the lives of donor-conceived children make for a bewildering, fragmented life.105 research supports this. recalling eli baden-lasar’s story, the young man who searched for and photographed as many of his half siblings as he could, and his understanding of his father’s nonchalant, even dismissive, legacy comment to all his children as saying, “may the odds be ever in your favor,”106—the odds are, well, frankly not in their favor. empirical data suggest that children do best when raised by their biological parents, married to each other.107 children conceived through donor conception suffer from delinquency, substance abuse, and depression at a significantly higher rate than children raised by their parents.108 certainly a child can do well outside of the household of marriedbiological parents, and there are many children outside of this environment who do thrive.109 and certainly these children are very much wanted and may very much be well loved.110 but still the data point to the optimal set of conditions for children, which are for their biological parents to be the ones raising them in a 104. oliver o’donovan, begotten or made?: human procreation and medical technique 48 (1984). 105. see marquardt et al., supra note 97, at 7-8, 11-12; wagner, supra note 85, at 171; goldman, supra note 86. a contrast between the modern practice of donor conception and a couple of ancient practices as recorded in the book of genesis is worth noting. the patriarchal pattern (as when hagar was offered to abraham to bear a child who would be considered the child of abraham and his then-barren wife sarah) and the institution of levirate marriage both presuppose “a close relationship between the representative and the represented, so that there is some meaning in the transfer of responsibility,” o’donovan, supra note 104, at 33-34, however inconceivable such transfer of responsibility seems to us modernly. by contrast, in the modern practice of donor conception, the gamete donor is kept “deliberately anonymous” and missing from the child’s life. id. at 34. 106. supra note 5 and accompanying text. 107. ryan t. anderson, truth overruled: the future of marriage and religious freedom 148-52 (2015); kristin anderson moore et al., marriage from a child’s perspective: how does family structure affect children, and what can we do about it?, child trends 1, 1-2, 6 (2002), https://www.childtrends.org/wp-content/uploads/2002/06/marriagerb602.pdf [https://perma.cc/3g6n-fb7z]; alysse elhage, how marriage makes men better fathers, inst. fam. stud. (june 19, 2015), https://ifstudies.org/blog/how-marriage-makes-men-better-fathers [https://perma.cc/clm9-nmte]; david c. ribar, children raised within marriage do better on average. why?, child & fam. blog (oct. 2015), https://www.childandfamilyblog.com/childdevelopment/children-marriage-do-better-why/ [https://perma.cc/4a8d-jmxm]; ana samuel, the kids aren’t all right: new family structures and the ‘no differences’ claim, pub. discourse (june 14, 2012), https://www.thepublicdiscourse.com/2012/06/5640/ [https://perma.cc/mj7832mm]. 108. marquardt et al., supra note 97, at 9. 109. moschella, supra note 73, at 41. 110. id. 288 indiana health law review [vol. 19:275 married household.111 thus the child may be well-loved by another parent, not the biological parent, and that parent may even do a better job raising the child, and yet there is still harm to the child for not being known, raised, and loved by his biological parents.112 adoptive parents merit a special mention here for being especially heroic: stepping in, picking up, welcoming, and grafting into their families children, not theirs biologically, who come from (already-existing) broken situations.113 but it is a very different case in donor conception, when the parents who raise you participated in your separation from your biological parent(s). here, the parents who raise you played a hand in creating that wound,114 as contrasted with adoptive parents, who care for children who already exist, whose circumstances are already less than ideal.115 research supports this painful internalization. empirical data show that donor-conceived children may suffer from greater psychological harm, and even physical harm, than adopted children.116 one might observe that whereas adoption serves the child,117 donor conception serves the parents, not the child.118 for children of donor conception, their own sense of alienation, loss, and longing may well sit in tension with the disposition of the parents who raised them. one person who was conceived with a donor sperm said, “my mom paid thousands of dollars for my creation, so for me to just tell her that i want to know where half of my dna has originated, for me to tell her that i want to look at the man that is my biological father in the eyes, for me to want more than just her in my life, it’s wrong.”119 one woman conceived through sperm donation, alana s. 111. id.; see supra note 107. 112. moschella, supra note 73, at 41; moschella, supra note 40, at 432, 435. 113. see o’donovan, supra note 104, at 36-37, 40; moschella, supra note 40, at 435; moschella, supra note 74, at 13. empirical data also suggest that adoptive children still struggle and carry the wound of separation from their biological parents, which is in line with the data that show that children do best when raised by their married, biological parents. anderson, supra note 107, at 148-52; moschella, supra note 40, at 435; see nicholas zill & w. bradford wilcox, the adoptive difference: new evidence on how adopted children perform in school, inst. fam. stud. (mar. 26, 2018), https://ifstudies.org/blog/the-adoptive-difference-new-evidence-on-howadopted-children-perform-in-school [https://perma.cc/y6zm-4ktu]. 114. moschella, supra note 8. 115. see marquardt et al., supra note 97, at 14; o’donovan, supra note 104, at 36, 40; moschella, supra note 40, at 435; moschella, supra note 74, at 13; goldman, supra note 86. 116. marquardt et al., supra note 97, at 28; moschella, supra note 40, at 435 n.32; moschella, supra note 8. other things that may be bothersome about donor conception, in particular to the children conceived with donor sperm, are the use of pornography and masturbation in the ejaculation of their donor sperm. see alvaré, supra note 32, at 10, 25, 44. 117. o’donovan, supra note 104, at 36-37. 118. id; alvaré, supra note 32, at 55. 119. katy faust, why it’s probably not a coincidence that the mother transing her 7-yearold isn’t biologically related, federalist (oct. 24, 2019), https://thefederalist.com/2019/10/24/ why-its-probably-not-a-coincidence-that-the-mother-transing-her-7-year-old-isnt-biologically2022] sperm and eggs in consideration of money 289 newman,120 said, “i knew from an early age that i was purchased and selected from essentially a catalog. i knew that my blonde hair and blue eyes was somehow valued above other colorations . . . i always knew that i was purchased and created precisely to make [my mother] happy[;] that was my raison d’etre.”121 yet another donor-conceived child, bethany, put it bluntly thus, “being ‘wanted’ can sometimes feel like a curse, like i was created to make you happy, my rights be damned.”122 unlike children in adoption, donor-conceived children may find it harder to grief their loss and to express it because doing so may be taken to mean that they reject the parents who have raised them, or else condemn these parents’ decision.123 relatedly, being raised in family with one’s biological siblings, those who are similarly situated to oneself, helps with identity formation and making sense of one’s self, which is also missing for donor-conceived children—which is yet another loss.124 anxiety about not knowing one’s family and extended family, along with its attendant problems like unwittingly meeting, dating, or marrying one’s half sibling;125 or not knowing one’s medical history from the donor parent’s side of the family;126 is also common among donor-conceived children. in one case, at least nineteen children were born in the same area in oregon from the sperm of a man, bryce cleary, who had given it to oregon health & science university’s fertility clinic.127 (the clinic told him that his sperm would be used to conceive babies in the east coast, and at most five babies at that.128) cleary went on to marry and have four children with his wife.129 the twenty-three related/ [https://perma.cc/487m-tska]. 120. alana s. newman, children’s rights, or rights to children?, pub. discourse (nov. 10, 2014), https://www.thepublicdiscourse.com/2014/11/13993/ [https://perma.cc/n6rp-ayre]. alana s. newman founded the “anonymous us project,” a website where children (and other characters) of third-party reproduction are welcome to share their stories. about, anonymous us, https://anonymousus.org/about/ [https://perma.cc/xjp2-gcm9] (last visited apr. 14, 2022). 121. katy faust, “#bigfertility” documentary exposes 3 ways surrogacy harms children, ctr. bioethics & culture network (july 24, 2019), http://www.cbc-network.org/2019/07/ bigfertility-exposes-ways-surrogacy-harms-children/ [https://perma.cc/ay6h-nv6e]. 122. faust, supra note 119. 123. see faust, supra note 80. 124. see moschella, supra note 73, at 40. 125. see ramsey, supra note 101, at 127-28; goldman, supra note 86. 126. see ramsey, supra note 101, at 127-28; goldman, supra note 86; sperm donation, ctr. bioethics & culture network, http://www.cbc-network.org/issues/making-life/sperm-donation/ [https://perma.cc/z45p-xzc5]; three things you should know about sperm “donation”, supra note 101. 127. meagan flynn, sperm donor who discovered he fathered at least 17 kids—most in the same area—says fertility clinic lied, wash. post (oct. 3, 2019, 3:51 am), https://www. wash ingtonpost .com/nation /2 0 1 9 /1 0 /0 3 /oregon -sperm-donor-children-lawsuit / [https://perma.cc/dn2b-v38j]; swenson, supra note 95. 128. flynn, supra note 127. 129. id. 290 indiana health law review [vol. 19:275 children now run the risk of meeting and interacting with each other without knowing that they are siblings.130 two of the children were students at the same elementary school, at least two were at the same high school, some others socialized in the same circles (social events, churches), and one had a job at a coffee shop not a few of blocks away from another child’s house.131 cleary himself, a medical student when he gave his sperm, is now a physician in corvallis, oregon, practicing in family medicine.132 at least one of the children lived in the same town, corvallis.133 one child worked in the very same building where cleary practiced.134 cleary is now faced by the possibility that, as a doctor, he may have treated his own children as a doctor without the slightest bit of idea.135 for eli baden-lasar,136 discovering early in his quest to find his half siblings that a friend he had known from a program in high school was actually his half brother was a moment of glee but also of horror. i knew that as a story it was mind-blowing, but it was also disturbing—to have the script switched, to go from friends to brothers. in our experiential-learning program, we were constantly being asked to write personal essays to try to understand our lives. for four months, we were doing that and reading each other’s work and sleeping on the same floor of a dorm, all the while not knowing that we were half brothers—the perversity of that was not lost on either of us.137 producing children with donor gametes is not appropriate, not honoring, to our nature as embodied beings of body-soul unity.138 it impoverishes us from our full humanity.139 put more bluntly, it is rather injurious to who we are as embodied beings: leading to a bewildering life, characterized by a sense of loss, fragmentation, and even woundedness—a “harm to the soul” spoken of earlier.140 b. children as (luxury) goods? a gamete has special properties as carriers of genes and identity of a 130. see id.; swenson, supra note 95. 131. flynn, supra note 127. 132. id.; swenson, supra note 95. 133. flynn, supra note 127. 134. swenson, supra note 95. 135. flynn, supra note 127. the man filed a lawsuit against oregon health & science university, where the fertility clinic was. one of the man’s four children in his marriage was an attorney, who represented his father in the lawsuit. id. 136. baden-lasar, supra note 1. 137. id. 138. see kass, supra note 77, at 100. 139. see id. 140. supra notes 69, 71, and accompanying text. 2022] sperm and eggs in consideration of money 291 person,141 properly thought of not as eggs or sperm “from” a person, but the eggs or sperm “of” a person.142 gametes are constitutive of some aspect of the self.143 should a gamete meet the other, requisite gamete, that meeting will produce a child—which is precisely what the contract for buying and selling gametes is for. in contrast to the classification of gametes and embryos as “property,” with which the property owners can do what they choose,144 i submit that the starting point of thinking through donor conception issues should be what the children are owed. put another way, the framework of consideration for the propriety of donor conception ought to be the respect for a basic and inherent aspect of the children’s well-being.145 this obligation to the child is every bit as valid and in need of honoring, no matter how “unchosen [an] obligation” it is, as what is owed to every member of the human family by virtue of our humanity.146 insofar that buying and selling gametes results in the making of babies, margaret jane radin’s oft-cited argument of market-inalienability applies. she argues that certain things in life should not be alienable, that is to say, they should not be sold or traded in the market.147 babies would be one.148 they should not be alienable, and in fact, when we permit baby-selling, we commodify babies.149 when we commodify these babies in the market, we really commodify all babies because of the domino effect on how we as a culture think of children.150 she says, “conceiving of any child in market rhetoric wrongs personhood. . . . conceiving of children in market rhetoric would foster an inferior conception of human flourishing, one that commodifies every personal attribute that might be valued by people in other people.”151 so leon r. kass says that in “[s]elling our bodies, we come perilously close to selling out our souls. . . . if we come to think about ourselves like pork bellies, pork bellies we will become.”152 141. o’donovan, supra note 104, at 43. 142. r. j. snell, a hard truth: ivf is not moral, culture life found. (jan. 24, 2020), https://cultureoflife.org/2020/01/24/a-hard-truth-ivf-is-not-moral/ [https://perma.cc/s9g6-5993]. 143. see r. j. snell, google and violating patients’ privacy: it’s worse than it appears, culture life found. (nov. 27, 2019), https://cultureoflife.org/2019/11/27/google-and-violatingpatients-privacy-its-worse-than-it-appears/ [https://perma.cc/hgf9-5xm7]. 144. see hecht v. superior court, 20 cal. rptr. 2d 275, 283 (1993); swanson, supra note 6, at 221-22; james e. bailey, an analytical framework for resolving the issues raised by the interaction between reproductive technology and the law of inheritance, 47 depaul l. rev. 743, 761-64, 768-70 (1998) (exploring that although gametes, zygotes, and embryos may be understood as property, whether they may be bequeathed is a different issue). see generally radhika rao, property, privacy, and the human body, 80 b.u. l. rev. 359, 416-17, 456-59 (2000). 145. moschella, supra note 8. 146. see snead, supra note 11, at 86-87, 101; lee & george, supra note 74, at 149. 147. margaret jane radin, market-inalienability, 100 harv. l. rev. 1849, 1850, 1909 (1987). 148. id. at 1925. 149. id. at 1925-28. 150. id. at 1926, 1933; see also spar, supra note 86, at 16-17. 151. radin, supra note 147, at 1927-28. 152. kass, supra note 77, at 195. 292 indiana health law review [vol. 19:275 recalling that the fertility industry deals in gametes not for the sake of gametes but to the end goal of producing children, following radin’s argument, gametes then should not be alienable.153 that is to say, they should not be sold or traded in the market.154 the commodifying nature inherent in the transaction of gamete selling155 is not proper to human beings, who should be begotten, not made or manufactured.156 children should not be treated as if they were consumer goods, even if luxury goods.157 there is something shocking in valuing some gametes (and their sources) more than others in how higher prices are paid to jewish, asian, or indian egg donors for their eggs,158 how the fertility industry prefers white sperm and egg donors,159 how higher prices are paid for “ivy eggs,”160 how sperm and egg banks require a minimum sat score or gpa for their donors,161 or how higher prices are paid for the eggs of pretty,162 tall,163 and athletic women.164 the flip side of valuing these gametes and their sources more than others is that rest are devalued.165 the practice suggests that the fertility industry does not believe that all men are created equal. rather discomfortingly, such practice also shares the logic of eugenics in choosing certain traits over others in human breeding. this tendency toward eugenics is captured by helen m. alvaré in her article, with one medical personnel involved in the industry commenting that “agencies report a steady stream of would-be parents smitten by the human tendency to want to improve on nature. for recipient couples, beauty often plays as large a role as any other 153. see also spar, supra note 6; moschella, supra note 40, at 422 n.4. thus alana s. newman pointedly asks, “is gamete-selling all that different from baby-selling?” newman, supra note 88. 154. see also spar, supra note 6; moschella, supra note 40, at 422 n.4. 155. alvaré, supra note 32, at 59; see also dickenson, supra note 30, at 30; swanson, supra note 6, at 229. 156. see o’donovan, supra note 104, at 1-2, 39-40; ramsey, supra note 101, at 137. 157. see tollefsen, supra note 86. 158. dickenson, supra note 30, at 37-38; alvaré, supra note 32, at 13; epstein & whitehouse, supra note 8; martineau, supra note 7. 159. goodwin, supra note 35, at 599, 608. 160. spar, supra note 6, at 64, 81, 99; epstein & whitehouse, supra note 8; schneider, supra note 26. 161. spar, supra note 6, at 46; alvaré, supra note 32, at 13 n.72; kari l. karsjens, boutique egg donations: a new form of racism and patriarchy, 5 depaul j. health care l. 57, 65 (2001); elitist and racist egg donation ads have no place in student newspapers, supra note 22; epstein & whitehouse, supra note 8. 162. alvaré, supra note 32, at 15 n.96; karsjens, supra note 161, at 65; wancata, supra note 31, at 200 n.4. 163. dickenson, supra note 30, at 37-38; swanson, supra note 6, at 232. 164. karsjens, supra note 161, at 65; elitist and racist egg donation ads have no place in student newspapers, supra note 22. 165. karsjens, supra note 161, at 64-65; see also dickenson, supra note 30, at 27. 2022] sperm and eggs in consideration of money 293 characteristics,” and a director of an egg donation program commenting that “the husband in particular, will always choose the prettiest, even if she looks nothing like his wife.”166 alvaré notes that the donor selection process has extended far beyond health considerations (for example, that the donor has good family medical history167) to other desired characteristics like thinness or academic prowess.168 after all, if we are already picking and choosing the gametes, why not choose certain (better?) ones over others? why not produce children who are more, not less, perfect?169 one might say that the eugenic nature of the donor conception is congenital.170 before the days of ivf as the vogue mode for donor conception, artificial insemination was used.171 it first developed in the field of animal husbandry, the improvement of stock being a goal (farmers trying to increase the yield of their dairy cow, or using the semen of “prize stud bulls and horses”),172 and the same reasoning was extended to humans for human artificial insemination.173 in the words of one researcher, “[w]hat is true for animals is also true of men.”174 its “benefits” were already cited in the earliest days of artificial insemination: dr. robert latou dickinson, the 1920’s president of the american gynecological society, made the approving suggestion that artificial insemination had “enormous potentialities of betterment of the race,”175 seemed to have 166. alvaré, supra note 32, at 16; sharon krum, american beauty, here is lauren bush, this year’s model. americans want her looks, her figure, even her brains, indep., june 17, 2001, at 1. 167. spar, supra note 6, at 46; alvaré, supra note 32, at 13. 168. alvaré, supra note 32, at 16, 25; see also spar, supra note 6, at 99-100; swanson, supra note 6, at 229-33; epstein & whitehouse, supra note 8. 169. gilbert meilaender, bioethics: a primer for christians 16 (3d. ed. 2013); spar, supra note 6, at 99-100; alvaré, supra note 32, at 54; smith, supra note 38; see also swanson, supra note 6, at 229-33; leon kass, address at the united states holocaust memorial museum: a more perfect human: the promise and peril of modern science (mar. 17, 2005). the “quality control” aspect of donor and gamete selection extends also to the selection of better embryos and fetuses over others, resulting in the “termination” of some of these lives, whether still in the laboratory or already in the womb. john finnis, c. s. lewis and test-tube babies, in human rights & common good 273, 278-80 (2013); alvaré, supra note 32, at 25. see generally robert p. george, conscience and its enemies: confronting the dogmas of liberal secularism 196-97, 200-02 (2013) (explaining how each person’s life starts at conception and how human embryos are embryonic humans, exploring its ethical implications). 170. see swanson, supra note 6, at 201-05. 171. id. at 199-218. 172. id. at 212-13. 173. id. at 212-14. 174. id. at 213. 175. wendy kline, building a better race: gender, sexuality, and eugenics from the turn of the century to the baby boom 66-67, 132-34 (2001); swanson, supra note 6, at 201-02; merriley borell, biologists and the promotion of birth control research, 1918–1938, 20 j. hist. biology 51, 64-73 (1987); robert latou dickenson, address of the president: 294 indiana health law review [vol. 19:275 avoided using the sperm of men who were “idiots, epileptic, hopelessly insane, or incurably criminal,”176 and was a proponent that women who were “idiots, epileptic, hopelessly insane, or incurably criminal” be sterilized.177 the realization of the embarrassing link between nazism and eugenics in the post-world war ii days cooled the overt enthusiasm for eugenics,178 but eugenics quietly lives on in the practice of donor conception.179 human beings (through their gametes) are ranked and priced nowadays in donor conception according to their traits. if artificial insemination was first started in animal husbandry with an eye toward improving stock,180 the early days of human artificial insemination met opposition that stemmed from the ethical, social, and legal implications related to this commodifying and dehumanizing tendency of the practice.181 it is unsurprising that today donor-conceived children are unsettled by the arrangement that brought them into being: a transaction, with money changing hands.182 “it bothers me that money was exchanged in order to conceive me,” forty-two percent said in a study of young adults conceived from donor conception.183 eli baden-lasar184 spoke of his project of photographing as many half siblings as he could as a balm of sorts: “the emotional labor of the project was intended to be almost reparative—a response to the transactional nature of the sperm bank and the financial exchange our parents made in order to create us.”185 the quid pro quo of money for the making of a child is unsettling, and suggestions for a program for american gynecology, 45 transactions am. gynecological soc’y 1, 6, 10-11 (1920). 176. swanson, supra note 6, at 203. 177. id. 178. id. at 209. see generally bessie blackburn, cited at nuremberg: the american eugenics movement, its influence abroad, the buck v. bell decision, and the subsequent bioethical implications of the holocaust, 4 bound away: liberty j. hist. 1, 1 (2021) (exploring the eugenics zeitgeist animating the time in the united states, much as it did in nazi germany). 179. swanson, supra note 6, at 225, 229-33; see also spar, supra note 6, at 101-27 (discussion of eugenics as a backdrop for the pursuit of a perfect baby). 180. swanson, supra note 6, at 212-13. 181. see id. at 209, 213-25; see also moschella, supra note 8. 182. marquardt et al., supra note 97, at 65; rennie burke et al., how do individuals who were conceived through the use of donor technologies feel about the nature of their conception?, harv. med. sch. ctr. bioethics (apr. 1, 2021), https://bioethics.hms.harvard.edu/ journal/donor-technology [https://perma.cc/6ta2-w67p]; see also newman, supra note 88 (“[i]t is unjust for children to have price tags.”). 183. marquardt et al., supra note 97, at 7. 184. see supra note 1 and accompanying text. 185. baden-lasar, supra note 1; goldman, supra note 86. baden-lasar chose to take pictures of his half siblings partly as a way to combat the commodifying nature of donor conception on children: the camera makes images that are rich and detailed. i wanted something that was going to feel like the opposite of mass production, that would have none of the slickness that i was starting to associate with the sperm bank. it has a clean, simple, commercial 2022] sperm and eggs in consideration of money 295 rightly so. oliver o’donovan says, “for whatever may be said about gametes,186 children are not property to be conveyed. the notion that one might undertake to become the parent of a child in order to alienate one’s parental relation to another, implicitly converts the child from a person to a commodity.”187 it is not proper for gametes to be the object of the bargained-for exchange in a contract because of the intrinsic nature of what gametes are,188 and because doing so is injurious to any children who are later produced. oliver o’donovan continues: “[w]e do not have to introduce the notion of payment to make it repugnant. the suggestion of a commercial transaction merely underlines what is already present in the deliberate purpose of incurring a parental relation in order to alienate it.”189 actually, then, because of the nature of gametes as lifeproducing, even if the gametes were a gift, that is, sans payment, making it an actual donation, it would still not be appropriate.190 leon r. kass was writing about surrogacy and prostitution here, but his remark is equally applicable to the sale of gametes in the market for children: “the buying and selling of human flesh and the dehumanized uses of the human body ought not to be encouraged” primarily because of its inherently degrading nature, and derivatively because money was involved.191 there is an impropriety of consideration or a quid pro quo of selling one’s (or another’s) life. blackstone was writing about the wrongness of slavery in the following, but his point speaks with clarity to the consideration of money for gametes: “every sale implies a price, a quid pro quo, an equivalent given to the seller in lieu of what he transfers to the buyer: but what equivalent can be given message about helping families and ads that present donors as superheroes, their future babies as geniuses. i wanted to produce something that would be exhaustive and overwhelming, that would complicate the industry’s message—that would refute any simple narratives. baden-lasar, supra note 1. 186. see infra notes 228-43 and accompanying text. 187. o’donovan, supra note 104, at 37; cf. radin’s critique of “universal commodification,” wherein everything is a commodity, including children. radin, supra note 147, at 1860-61. with regard to the transaction and the commissioning parents, oliver o’donovan asks a hard question: “[w]hat kind of identification, we must ask, might be appropriate for an act so personal? a friend may guide my hand upon the saw while i try to build a bookcase; but who may guide my hand while i embrace my wife?” o’donovan, supra note 104, at 42. furthermore, if we still find ourselves thinking of the gift of sperm or ovum as the gift of self, and if we still revolt against the idea that it may be saleable? . . . . then, it seems to me, we should recognize that we are thinking in terms, which, of themselves, ought to make aid [artificial insemination by donor] unthinkable. we are thinking in terms of a third personal presence in procreation, a presence which cannot be effaced. id. at 44. 188. o’donovan, supra note 104, at 42-44; see also dickenson, supra note 30, at 30. 189. o’donovan, supra note 104, at 37. 190. we might add consent to the list: consent does not change the inherent wrong in such alienation. see dickenson, supra note 30, at 37; see infra notes 263, 324. 191. kass, supra note 77, at 101. 296 indiana health law review [vol. 19:275 for life, and liberty, both of which (in absolute slavery) are held to be in the master’s disposal?”192 blackstone is apt to be considered here because the inherent relationship of parent and child, conceived through means like donor conception or ivf, has been observed to be—as hard as this is to countenance—one of maker and a thing made; artificer and artifice; superior and inferior; master and slave, even.193 it is a relationship marked by domination, with its attendant “attitude of mastery and manipulation” toward the artifice,194 as opposed to one that honors the inherent equality between the two.195 if human beings ought to be begotten and not made, it is the made-ness of the child that puts him at an inferior status vis-à-vis his parent, because the parent enjoys the status of having been begotten himself.196 this is true, oliver o’donovan explains, because our offspring are human beings, who share with us one common human nature, one common human experience and one common human destiny . . . . but that which we make is unlike ourselves . . . . in that it has a human maker, it has come to existence as a human project, its being at the disposal of mankind. it is not fit to take its place alongside mankind in fellowship . . . . to speak of ‘begetting’ is to speak of . . . the possibility that one may form another being who will share one’s own nature, and with whom one will enjoy a fellowship based on radical equality.197 in this light, the impropriety of selling gametes that become human beings is evident. the coarsening, commodifying, and dehumanizing nature of the practice of donor conception, and the parallels between it and slavery are deeply uncomfortable and unnerving. blackstone’s question haunts us. if the consideration in donor conception, the “quid pro quo” of which he spoke, is money for what becomes our children, then how could that ever be justly “equivalent,” satisfying the requirement of justice in commutative justice? how could what ought to be inalienable be properly the object of sale? in blackstone’s forceful inquiry once more, “what equivalent can be given for life, and liberty, both of which . . . are held to be in the master’s disposal?”198 might sperm and eggs be an “immoral object” in consideration spoken of earlier?199 c. the health risks of donor conception placing into focus here the physical health of the egg donor and donor192. 1 william blackstone, commentaries *412. 193. finnis, supra note 169, at 276-79, 281; o’donovan, supra note 104, at 1-2; tollefsen, supra note 86; see also o’donovan, supra note 104, at 15, 42-43. 194. tollefsen, supra note 86; see finnis, supra note 169, at 276-79; o’donovan, supra note 104, at 1-2. 195. finnis, supra note 169, at 276-77; o’donovan, supra note 104, at 1-2. 196. o’donovan, supra note 104, at 1-2; see also id. at 15; tollefsen, supra note 86. 197. o’donovan, supra note 104, at 1-2; see also id. at 15. 198. blackstone, supra note 192, at *412. 199. supra notes 68, 70 and accompanying text. 2022] sperm and eggs in consideration of money 297 conceived children, it is worthy of note that, first, egg donation poses health risks. the process of egg donation is not only much more involved than sperm donation,200 it is also risky, with some risks under-researched and much remains unknown.201 the process of eggs harvested for ivf includes known risks of “three stages of ovarian function suppression, ovarian hyperstimulation, and egg extraction under anesthetic,”202 ovarian torsion, ovarian cysts, loss of fertility, premature menopause, kidney disease, and stroke.203 donna dickenson says, “it is quite incredible that in an age when evidence-based medicine is the universal mantra, we know so little about the long-term risks of hyperstimulation, cancer, or infertility to healthy young women from egg provision.”204 lupron, a drug needed to stop the donor’s ovarian function, is a drug that the food and drug administration has not approved.205 it has been given a “category x” rating: should the donor become pregnant while taking lupron, the baby in her womb would be at risk for harm.206 aside from this, there may also be risks unknown: there have been no studies done on the long-term effects on the donor for donating eggs.207 if it is disclosed to the young women who are considering selling their eggs that the process involves no known risks for the long term, it is easily misheard as there being no risks for the long term—which of course is not the same thing at all.208 the center for bioethics and culture network warns that egg donation is, soberingly, “uncharted territory.” anecdotal accounts of egg donors who have become very sick or died following the procedure are harrowing.209 dr. jennifer schneider wrote on the death of her daughter jessica, who had been a graduate student at stanford 200. snead, supra note 11, at 192; epstein & whitehouse, supra note 8; martineau, supra note 7. 201. spar, supra note 6, at 46; 43; jennifer lahl, what we don’t know just might kill you, pub. discourse (jan. 30, 2015), https://www.thepublicdiscourse.com/2015/01/14353/ [https:// perma.cc/2lpq-dlpb]. 202. dickenson, supra note 30, at 25; martineau, supra note 7. 203. institute of medicine and the national research council of the national academies, assessing the medical risks of human oocyte donation for stem cell research: workshop report (2007); three things you should know about sperm “donation,” supra note 101. 204. dickenson, supra note 30, at 41; see also lahl, supra note 203; martineau, supra note 7. 205. three things you should know about sperm “donation,” supra note 101. 206. id. 207. id. 208. egg “donation” and exploitation of women, ctr. bioethics & culture network, http://www.cbc-network.org/issues/making-life/egg-donation-and-exploitation-of-women/ [https://perma.cc/k99y-kd4n] (last visited apr. 15, 2022). 209. see generally martineau, supra note 7; diane tober, student debt is driving more americans to donate their eggs—and some suffer lasting complications, salon (feb. 14, 2021, 7:30 pm), https://www.salon.com/2021/02/14/student-debt-is-driving-more-americans-to-donatetheir-eggs--and-some-suffer-lasting-complications/ [https://perma.cc/3t8q-w8dn]. 298 indiana health law review [vol. 19:275 university.210 jessica died at the age of thirty-one of colon cancer after donating her eggs three times.211 there was no family history of cancer.212 maggie eastman is another egg donor, age thirty-two years old. after going through ten rounds of egg retrievals, she was diagnosed with stage 4 breast cancer.213 she then had to undergo a hysterectomy.214 another young woman almost died after seventy of her eggs were retrieved in one cycle.215 as donor conception these days often involves ivf, health problems known to affect the children born of it are also worthy of concern. the risks for ivf babies include fetal growth restriction,216 gestational diabetes,217 pre-eclampsia,218 low or very low birth weight,219 a near fourfold increase in premature birth,220 a fourfold increase in caesarean section birth,221 increased nicu admission and longer hospital stay,222 and a four-to-fivefold increase in stillbirth.223 additionally, children conceived through sperm donation, now adults reporting on their own health, suffer from a higher rate of type 1 diabetes, sleep apnea, acute bronchitis, thyroid disease, allergies, and other autoimmune diseases.224 it is thought that the 210. jennifer schneider, fatal colon cancer in a young egg donor: a physician mother’s call for follow-up and research on the long-term risks of ovarian stimulation, 90 fertility & sterility e1-5 (2008). 211. id. at e-1. 212. id. 213. jane ridley, ‘being an egg donor gave me terminal cancer,’ n.y. post (dec. 3, 2015, 6:00 am), https://nypost.com/2015/12/03/being-an-egg-donor-gave-me-terminal-cancer/ [https:// perma.cc/tsr8-jaze]. 214. id. 215. dickenson, supra note 30, at 41; allen jacobs et al., seventy ova, 31 hastings ctr. rep. 12 (2001). 216. esme i. kamphuis et al., are we overusing ivf?, 348 brit. med. j. 252, 253 (2014). 217. id. 218. id. 219. laura a. schieve et al., low and very low birth weight in infants conceived with use of assisted reproductive technology, 346 new eng. j. med. 731, 734-36 (2002). 220. t.a. merritt et al., impact of art on pregnancies in california: an analysis of maternity outcomes and insights into the added burden of neonatal intensive care, 34 j. perinatology 345, 348-49 (2014); see also stephanie m. caballero, gestational surrogacy in california, in handbook of gestational surrogacy: international clinical practice and policy issues 296, 302 (e. scott sills ed., 2016); kamphuis et al., supra note 216, at 253. 221. merritt et al., supra note 220, at 348-49. 222. caballero, supra note 220, at 302; merritt et al., supra note 220, at 348-49; yona nicolau et al., outcomes of surrogate pregnancies in california and hospital economics of surrogate maternity and newborn care, 4 world j. obstetrics & gynecology 4 (2015). 223. merritt et al., supra note 220, at 348-49; see also kamphuis et al., supra note 216, at 253. 224. damian h. adams et al., self-reported physical health status of donor-conceived adults, j. dev. origins health & disease 1-14 (2020); donor-conceived adults have higher incidence of immunology diseases, sci. daily (sept. 23, 2020), https://www.sciencedaily.com/ releases/2020/09/200924101846.htm [https://perma.cc/g23h-h3mh]. 2022] sperm and eggs in consideration of money 299 higher rate of pre-eclampsia for pregnancies using donated gametes may be a reason for the immunological changes in the bodies of those conceived with sperm donation.225 so donor conception carries concerning risks, both known and unknown, particularly for egg donors and donor-conceived children. these risks indicate that it is worrisome enough for the women who donate their eggs, but, further, it is troubling to subject children knowingly to these risks through the necessary processes involved in donor conception. it is one thing for children who are conceived in a conjugal union between a man and a woman to suffer from natural illnesses, but quite another ethically to bring forth children under this cloud of known risks.226 the health risks of donor conception ought not to be ignored or glossed over—and they call into question the fulfillment of that requirement in consideration, historically understood, of “safety of the body.”227 d. some counter-arguments considered but surely it is not so bad, donor conception can’t be. to begin with, it’s not that babies are actually being bought and sold, like a scene out of some grotesque ancient foreign market. here, the market is for nothing more than sperm and eggs. no less than the federal government condones it in the national organ transplant act [nota]. and even if the transaction does produce babies, well, aren’t children a good thing? these are some popular counter-arguments, and below is a brief consideration of each. 1. for sale: strictly gametes, no children what to make of the transaction between the buyer and seller as for, emphatically, gametes, not babies? how should we consider the argument that what is being bought and sold here is not human beings, but only gametes? it is telling that those who buy gametes are setting up a nursery after the transaction.228 buyers are patently not buying gametes merely to collect them. debora l. spar bluntly puts it this way: “when [buyers] buy eggs, for example, they aren’t really interested in the eggs per se, but rather in the person they suspect those eggs will become.”229 thus kara w. swanson is admirably truthful with the choice of the following title for a chapter on the sperm market in her book: “buying dad from the sperm bank.”230 if “dad” is what one buys from the 225. donor-conceived adults have higher incidence of immunology diseases, supra note 224. 226. o’donovan, supra note 104, at 83. 227. supra notes 69, 71 and accompanying text. 228. newman, supra note 88. thus alana s. newman asks, “do vials of sperm require crib mobiles and changing tables? no, babies do.” id. 229. spar, supra note 6, at xvi. 230. swanson, supra note 6, at 198-237. cf. debora l. spar’s “daddy arrived via fedex” for how the sperm came to the buyer. spar, supra note 6, at 38. 300 indiana health law review [vol. 19:275 sperm bank, a baby is what one buys with a sperm (or egg). sometimes the mask slips on the other side too.231 dr. bryce cleary, whose sperm donation earlier in life has resulted in, so far, nineteen children,232 said that the children may have been an abstraction to him once.233 but no longer: “now they were real people, people whose hands he had shaken, young men and women with their own children and families, lives he could see on facebook.”234 conflicted about his moral and ethical responsibilities toward these children, he said to himself, “hey, wait. these are human beings running around with your genes.”235 indeed. one egg donor said that she would check once a month or so to find out whether her eggs have (been fertilized and) produced children.236 she had also stipulated that the buyers of her eggs be in a financially stable situation.237 another revealed why she cared about the state of the buyers’ finances: “i would like for my genetic children to have at least the standard of living that i had growing up, and hopefully better.”238 but why check to see whether there is any news, if all one is selling is eggs qua eggs, not eggs for their procreative potential? why care about the buyers’ financial state, so long as they pay for the eggs, one and done? alas, the egg donor who spoke of envisioning an acceptable standard of living for her “genetic children” spoke the hard truth. no one buys eggs and sperm just to have eggs and sperm: it is the making of children that is the aim of this buying and selling of eggs and sperm. melissa moschella considers the gamete donation qua gamete, contrasted to a gamete that is later united with another gamete to form a child: the act of donation itself, therefore, cannot be done out of love for the child. nor, by the same token, is the act of donation in itself a harm to the child. however, it is wrong (incompatible with a will toward integral human well-being) because it involves acting in a way that will foreseeably lead to the acquisition of a weighty, personal obligation, with the intention of not fulfilling that obligation should it arise.239 put another way, gamete donors, by acting in a way that will foreseeably lead to their becoming a biological parent precisely on condition that they will not be called upon to raise the resulting children, thus act wrongly by failing to show adequate respect for the well-being of their future children. their 231. supra note 101. 232. see swenson, supra note 95; supra notes 127-35 and accompanying text. 233. swenson, supra note 95. 234. id. 235. id. 236. epstein & whitehouse, supra note 8. 237. id. 238. id. 239. moschella, supra note 74, at 13-14 (emphasis added); see also moschella, supra note 8. 2022] sperm and eggs in consideration of money 301 wrong consists in a conditional willingness (it is conditional because there is no certainty that a child will actually come into existence with the help of their donation) to harm their future children by depriving them of important benefits: the benefits of being loved and raised by their biological parents.240 there is an argument to be made that culpability would not extend to those gametes that don’t become children, but for those that do, let it be made clear that culpability is owed to none other than children who ended up being conceived out of the sold gametes.241 the gametes that become babies grow up to be children, then adults, like everyone else.242 they are owed what is rightfully theirs by virtue of their humanity and inherent worth. that includes being known, raised, and loved by their genetic parents. if their parents’ action creates a situation wherein the children are intentionally cut off from these things, as is the case with donor conception,243 such action ought not to be done. 2. nota says it’s okay: let us buy and sell away nota prohibits the sale of human organs, although donation is encouraged.244 the senate report that accompanied the act revealed the rationale for the legislation: that “human body parts should not be viewed as commodities.”245 by contrast, body parts such as hair, blood, breastmilk, and 240. moschella, supra note 74, at 15; wagner, supra note 85, at 146; see also alvaré, supra note 32, at 11, 15, 25 (disclaimer of parental rights as a standard part of the agreement signed by sperm and egg donors); moschella, supra note 40, at 424, 437-39; wagner, supra note 85, at 92. thus donor conception is to be distinguished from cases in which genetic parents, by reason of, for example, genuine incompetence, decides to give up the child for adoption. moschella, supra note 40, at 436. key to this distinction is that the decision to give up the child due to genuine incompetence is made after the child comes into existence, not before, as in the case of donor conception. id. incidentally, this argument shines light on the error of the argument that it is proper for embryos to lack full recognition of legal personhood compared to those more developed gestationally, whether inside or outside the womb; and as a corollary, that the propriety of the alienability of gametes (as the materials used to the end of producing children) and embryos would not be in question. see, e.g., robertson, supra note 86, at 103-04; see also bailey, supra note 144, at 764-66 (1998). because human embryos are embryonic humans, george, supra note 169, at 196-97, 200-02, these embryos will grow up to be children with needs, longings, and questions. the rights of the children produced in this way cry out. if the buying and selling children is wrong, so is the buying and selling of the gametes, whose sale is for the very purpose of producing such children. 241. see moschella, supra note 74, at 13-14, 15. 242. marquardt et al., supra note 97, at 80. 243. see moschella, supra note 8. 244. national organ transplant act, 42 u.s.c. § 274(e); kass, supra note 77, at 178; snead, supra note 11, at 47; see reddix-smalls, supra note 7, at 646 (2008). 245. s. rep. no. 98-382, at 17 (1984). but see kass, supra note 77, at 177-98, for an 302 indiana health law review [vol. 19:275 gametes are not covered in the text of nota and are sold in the market.246 thus it is commonly understood that nota allows for the sale of gametes, with the rationale that they are replenishable, as in the case of sperm, blood, hair, and breastmilk; or plentiful, as in the case of ova.247 but in fact, organs and body parts, unlike gametes, “do not convey [a person’s] genetic individuality”248 and do not have the potential of producing other human beings, with inherent rights owed to them.249 if sale of organs is exploration of whether organ donation is appropriate, apart from its legality. 246. kristy williams, the hidden economy of hsc transplantation is inconsistent with prohibiting the compensation of hsc donors, 16 minn. j. l. sci. & tech. 215, 240 (2015); see swanson, supra note 6, at 11, 15-24, 30-38; rao, supra note 144, at 375-77; reddix-smalls, supra note 244 at 646, 664. but see swanson, supra note 6, at 167 (explaining how breastmilk is perceived and treated differently in the market due to the absence of market rhetoric for it). the law with regard to other body parts are a bit all over the map. for example, it has been found that there is no cause of action in conversion for a person’s spleen that has been used without his consent for research, generating lucrative economic results, moore v. regents of university of california, 793 p.2d 479 (cal. 1990); that there is no ownership interest retained by donors in donated biological materials, wash. univ. v. catalona, 490 f.3d 667, 673 (8th cir. 2007); more recently after the passage of nota, that bone marrow is excluded from the prohibition of human organ sale in nota, flynn v. holder, 684 f.3d 852, 865 (9th cir. 2012). see generally rao, supra note 144, at 437-38 (considering the holdings of both moore and hecht through the lens of privacy law). there was also a ruling that a decedent’s sperm “sufficiently constituted property” as understood under the california probate code. hecht v. superior court, 20 cal. rptr. 2d 275, 283 (1993). but even if sperm or eggs could be viewed as property, see, e.g., bailey, supra note 144, at 759, 773-75; rao, supra note 144, at 365-87, whether they should be alienable is a different question. this is the line of thought in the argument that although a woman’s body is her own, prostitution and surrogacy commodify her body such that her very person is commodified, and because of that, prostitution and surrogacy should not be alienable. see radin, supra note 147, at 1921-36; see also bailey, supra note 144, at 761-64, 768-70 (exploring that although gametes, zygotes, and embryos may be understood as property, whether they may be bequeathed is a different issue). see generally swanson, supra note 6, at 221-22; rao, supra note 144, at 416-17, 456-59. 247. williams, supra note 246, at 240; kristy lynn williams et al., just say no to nota: why the prohibition of compensation for human transplant organs in nota should be repealed and a regulated market for cadaver organs instituted, 40 am. j. l. & med. 275, 293 (2014); see also dickenson, supra note 30, at 25, 42-43; swanson, supra note 6, at 15-24, 30-38; robert p. s. jansen, sperm and ova as property, 11 j. med. ethics 123, 123 (1985). this rationale is reflected in multiple reports of congressional intent, including in the 1984 bill sent to president ronald reagan for his signature: that the “term ‘human organ’ is not intended to include replenishable tissues such as blood or sperm,” complaint at 34-35, flynn v. holder, no. 2:09-cv-07772) (c.d. cal. oct. 26, 2009); john a. robertson, paid organ donations and the constitutionality of the national organ transplant act, 40 hastings const. l. q. 221, 229 (2013); williams, supra note 246, at 240. 248. o’donovan, supra note 104, at 43; see also spar, supra note 6, at 17 (noting that gamete-selling exploits donors); swanson, supra note 6, at 11; jansen, supra note 247, at 124-25. 249. see bailey, supra note 144, at 774-75, 813-14; moschella, supra note 74, at 13-15; 2022] sperm and eggs in consideration of money 303 prohibited, certainly gametes should be also.250 by allowing for the sale of gametes, nota here is consistent with the impoverished understanding of the human person that animates our nation’s bioethics laws (when there are laws to regulate these matters at all): the assumption that people are atomized, independent, autonomous, self-determining individuals, forgetting our embodiment as the very fabric of our nature, as our lives as actually lived in reality.251 others argue for the opposite position: if gametes are allowed to be sold, so should organs be—arguing that commodification of the human body is here to stay252—and the way forward is merely to regulate such commodification, not eradicate it.253 but commodifying gametes and children (and commodifying human flesh generally, as in the sale of organs) is not proper to the nature of human beings: it leads to dehumanization and is injurious to our well-being. thus it should not be done, as opposed to merely tolerated and regulated. donna dickenson makes an arresting comparison to murder laws: we certainly don’t stop criminalizing murder although people still commit murder against each other.254 so she argues that proponents of regulation are really standing for a position of “won’t regulate” as opposed to “can’t regulate.”255 france, for example, opted to make the sale of ova unlawful.256 but perhaps the “idols of the marketplace” explains much of the laxity of donor conception and the fertility industry.257 “big fertility,”258 might this idol be called? some argue that just as organ donors are reimbursed for the costs associated with the process of donating the organ—while not allowing for payment for the organ itself259—so are gamete donors reimbursed for their time and trouble,260 particularly for egg donors, who have to go through an arduous procedure for the egg extraction.261 but if this were true, surely the different price points paid for wagner, supra note 85, at 146; see also moschella, supra note 40, at 424, 437-39. 250. dickenson, supra note 30, at 42-43; karsjens, supra note 161, at 73-75. 251. see snead, supra note 11, at 3, 7, 8, 12, 40-41, 64, 70, 78-79, 89-90, 96-96, 104-05, 191, 202, 206-07, 218, 221; see also roscoe pound, the spirit of the common law 13 (1999). 252. spar, supra note 6, at xv, 196. 253. see, e.g., epstein, supra note 16, at 50, 60, 64; spar, supra note 6, at xvii-xix, 196, 20304, 217-24; spar, supra note 86, at 19-20; swanson, supra note 6, at 8, 243-52; goodwin, supra note 35, at 632, 634. 254. dickenson, supra note 30, at 22. 255. id. 256. id. at 23. 257. id. at 34. 258. as aptly coined by the center for bioethics and culture. center for bioethics and culture, #bigfertility: it’s all about the money, vimeo (sept. 17, 2018), https://vimeo.com/ ondemand/bigfertility [https://perma.cc/p3gf-wu5s] (the documentary focuses on surrogacy, an issue within the fertility industry related to donor conception). 259. s. rep. no. 98-382, at 16. 260. wancata, supra note 31, at 222-23; martineau, supra note 7. 261. dickenson, supra note 30, at 25, 43; see snead, supra note 11, at 192; epstein & 304 indiana health law review [vol. 19:275 certain eggs over others262 betray the narrative. there would be no reason to pay the pretty, tall, ivy league jewish, asian, or indian woman more than other women for the exact same procedure, time, and trouble undergone by all of them. the different price points testify to the reality of the world of egg-selling.263 3. children, a very good thing lastly, potential sperm and egg donors are frequently courted with the noble call to help in this “market where sellers often cloak their wares in the language of charity”264: “[g]ive the gift of life and love,”265 or “give the gift of family.”266 and of course, for the parent(s) seeking to buy gametes to have children, what they seek is a good and worthy end. children are a good thing, and indeed, a very good thing. but means matter as ends do—good ends don’t justify the means.267 we ought not to use children as means because people should never be made into mere tools: doing so is unworthy of and dishonoring to man’s inherent rational nature.268 “man contradicts his rational being by treating his body as a mere instrument,” leon r. kass says, precisely because of our body-soul unity.269 despite the very best of intentions from the buyers and sellers of the gametes, whitehouse, supra note 8; martineau, supra note 7. 262. see supra note 26 and accompanying text. 263. my position is that the nature of a gamete as life-, thus child-producing, upon unity with another gamete makes its transfer inappropriate, even if no payment is involved. see supra note 190, infra note 324 and accompanying text. 264. spar, supra note 6, at 196. but see swanson, supra note 6, at 233-35, for the gendered differences in the market practice for sperm and eggs, with the emphasis on helping others for egg donors. see also spar, supra note 6, at 42-44, for the altruistic history and subsequent coloring of the practice, or at least the marketing, of egg donation. 265. spar, supra note 6, at 46; james herbert, donation dilemmas: selling of eggs gives birth to controversy, san diego union-trib., sept. 3, 2000, at e1. 266. top reasons to donate sperm, cal. cryobank, https://www.spermbank.com/whydonate/top-reasons-to-donate-sperm [https://perma.cc/f86z-bvqc] (last visited apr. 15, 2022). see, for e.g., become an egg donor, elite fertility sols., https://www.elitefertility.com/ become-an-egg-donor/ [https://perma.cc/rjp5-zrwr] (last visited apr. 15, 2022) (“you can help couples build a family.”); why donate sperm, fairfax cryobank sperm donor program, https://www.beaspermdonor.com/why-donate/ [https://perma.cc/379e-bsr9] (last visited apr. 15, 2022) (“you can directly help someone realize their [sic] dream of having a healthy, happy baby!”); why donate?, sperm bank cal., http://donors.thespermbankofca.org/ [https://perma.cc/zz9y5qyg ] (“help someone have the family they [sic] always wanted.”). 267. finnis, supra note 50, at 43-44. 268. see john finnis, on producing human embryos, in intention & identity 293, 299 (2013) (specifically with regard to child-producing using ivf); george, supra note 51, at 57, 60; moschella, supra note 40, at 437; see also kass, supra note 77, at 185; newman, supra note 88. 269. kass, supra note 77, at 185; see also dickenson, supra note 30, at 31, 37; supra notes 72-76 and accompanying text. 2022] sperm and eggs in consideration of money 305 there is an objective loss for the children. from the perspective of donorconceived children, even when they are thankful and happy for their existence, which in their particular case would not have happened without donor conception, they may well still feel wronged by it, and grieve the loss of all that donor conception has wrought.270 the pain of those who seek to have children but cannot is nothing short of grievous, heart wrenching.271 the desire to have children is surely deep and innate, written into our being.272 so it is hard to hear this conclusion: that it may be that the technology of donor conception exists for making children, but it would be wise for us to refrain from using it. and yet an examination of what is required of our nature and the evidence of what donor conception has done to children and egg donors, in particular, leads us to that conclusion. gilbert c. meilaender says of the thinking that we must explore what is available to us “the tyranny of the possible.”273 similarly, paul ramsey observes that “man the selfcreator seems also the slave of the actions that biology now makes possible.”274 just because we can do it, does not necessarily mean that we should. v. selling a pound of flesh (and blood) perhaps a turn to considering the matter through the lens of shakespeare’s the merchant of venice might lend us a fresh perspective.275 the play, i think, speaks to the issue of donor conception in compelling and poignant ways: it is a vivid tale that forces us to reckon with the wrongness, the grotesque ugliness of the buying and selling of the flesh. two aspects will be considered here: first, the role of usury and its relationship to commutative justice, and second, the commodification of the body (and the person). a. usury and commutative justice in the play, bassanio borrows three thousand ducats from shylock because he needs money to court the beautiful and wealthy heiress portia276—with a 270. see moschella, supra note 40, at 436 n.33; francisco. supra note 96; newman, supra note 88. 271. see spar, supra note 6, at 4-6. while the focus in this article is on the children and donors, the would-be parents’ pain, vulnerability, and desperation seem to make exploitation by the fertility industry only easier, which is to say, worse. see snead, supra note 11, at 221. 272. see spar, supra note 6, at 4-6. 273. meilaender, supra note 169, at 96. 274. ramsey, supra note 101, at 108. 275. if this turn to the bard is a bit too surprising, permit me to cite thus, “for, as the poet well knows, as does also the seer and prophet, it is only by means of these hidden analogies that the greatest truths, otherwise inexpressible, can be given a form or shape capable of being grasped by the human mind.” caroline f. e. spurgeon, shakespeare’s imagery and what it tells us 7 (2014). 276. william shakespeare, the merchant of venice act 1, sc. 1, ll. 160-85; id. act 1, sc. 3, ll. 1-12; marjorie garber, shakespeare after all 284, 297 (2004). 306 indiana health law review [vol. 19:275 pound of flesh of his best friend antonio’s body as the bond.277 antonio and bassanio are young men in the story.278 there is an interesting similarity here with how donors in donor conception tend to be young people, college students or professionals, many of whom needing money for their student loan debt.279 they look to get paid with money in exchange for (a type of) their flesh: their gametes—but then again, a type of flesh that may well become their own flesh and blood. the charging of interest—or to be more precise, the charging of excess interest—was understood as usury.280 usury was frowned upon in the medieval age.281 canon lawyers understood usury as a violation of commutative justice:282 because the interest charged in usury exceeds that of the normal rate of lending,283 the requirement of exchange of equal values in commutative justice is violated.284 chief of the concerns about usury was whether money should be allowed to “breed.”285 for canon lawyers, it was not profit-making per se that was the issue as much as it was “shameful profit” (turpe lucrum, “filthy lucre”), which was associated with greediness in business.286 (this view seemed to hold centuries later, as reflected in blackstone’s writing on usury.287) it is no surprise that usury by the time of shakespeare was viewed as a contract in which people would bind themselves “into debts that would kill them” 277. shakespeare, supra note 276, act 1, sc. 3, ll. 142-50; see kenji yoshino, a thousand times more fair: what shakespeare’s plays teach us about justice 40 (2012). 278. see garber, supra note 276, at 284. 279. epstein & whitehouse, supra note 8; moschella, supra note 8; tober, supra note 209. 280. see berman, supra note 56, at 132; garber, supra note 276, at 305. 281. see berman, supra note 56, at 132. 282. see gordley, origins, supra note 45, at 14. 283. see blackstone, supra note 67, at *462-63 for a list of acceptable interest rates from sundry eras, from the time of the romans (twelve percent) to elizabethan england (eight to ten percent; reduced to five percent thereafter). 284. see berman, supra note 56, at 132. 285. garber, supra note 276, at 305. aristotle was against it, as were, for example, dante’s virgil in inferno, canon lawyers, and francis bacon. dante alighieri, inferno 115, 436 (anthony esolen trans., 2003); w. h. auden, lectures on shakespeare 79 (arthur c. kirsch ed., 2019); berman, supra note 56, at 132; blackstone, supra note 67, at *455; garber, supra note 276, at 305. 286. berman, supra note 56, at 132; cf. hirschfeld, supra note 47, at 136 (the thomistic framework for the charging of interest can take into account loan-servicing, risks, or expected inflation); john kerrigan, shakespeare’s binding language 189 (2018) (in the elizabethan era, usurers were commonly viewed as “cheating and mendacious”); brian m. mccall, to build the city of god: living as catholics in a secular age 175-83 (2014) (explaining and exploring the historic catholic understanding of the difference between legitimate investment of money as a type of productive property that can be used without being consumed completely, akin to planting a potato seed to grow potatoes; and usury, which inwardly would involve a desire to do harm to the debtor, and outwardly as evinced in the lending of money with a high interest). 287. blackstone, supra note 67, at *455-58. 2022] sperm and eggs in consideration of money 307 due to such a high cost:288 “a slow death,” or even “manslaughter.”289 this understanding of usury was reflected in the 1571 acte against usurie in england at the time of shakespeare: it softened the former prohibition against usury to prohibiting only contracts that charged an excessive amount of interest, defined to be in excess of ten percent per year.290 while the christian teaching governing usury applied to all transactions of which christians took part,291 jews were allowed to engage in usury with nonjews, although they were prohibited to do so with fellow jews.292 technically, it is the bond of the pound of flesh that shylock (cast as jewish by shakespeare) considers to be his consideration for the loan293—except he wants it in the form of a pound of antonio’s flesh as specific performance, not mere money as damages.294 but its connection to usury is of particular interest.295 the poet w. h. auden comments that one reason for our alienation of sympathy to shylock is because “his revenge is in excess of the injury,”296 with its connection to the prohibition against usury as understood as the charging of excess interest readily seen. we understand that shylock is justly owed his money back, and we can understand that he demand a bond for it—but the bond of a pound of flesh is just too much for what is owed, and actually not at all appropriate: grotesque, shocking, injurious to the point of death, even malicious. it would be a clear violation of commutative justice because of the inherent unequal exchange of the transaction: money for human flesh, even possibly human life. the human body and the human person ought not to be up for sale. this is a high view of the human body and person that is not subscribed to universally in our late-modern age, but it is one that shakespeare successfully 288. see kerrigan, supra note 286, at 189. 289. see id. 290. yoshino, supra note 277, at 38. 291. it is interesting to note that dante placed those who committed usury rather low in the circles of hell, in canto seventeen of inferno. dante, supra note 285, at 171-75. anthony esolen notes in his commentary on dante that he “seems to condemn all brokerage, whereas his master aquinas admitted that, as all goods command a just price, so could the use of money.” id. at 436; see also id. at 450. 292. deuteronomy 23:19-20; yoshino, supra note 277, at 38; see also kerrigan, supra note 286, at 189. 293. see yoshino, supra note 277, at 40-41; see also blackstone, supra note 67, at *444 (explaining that “loans of money upon bond” provide consideration for a contract). or it may be viewed as “a free loan with forfeiture” of antonio’s flesh. see kerrigan, supra note 286, at 155, 161. but see christina g. waldman, francis bacon’s hidden hand in shakespeare’s the merchant of venice: a study of law, rhetoric, and authorship 127 (2018) (regarding the seal for the bond as what furnished the consideration, although also noting that antonio the person becomes the quid pro quo for the transaction). 294. see shakespeare, supra note 276, act 1, sc. 3, ll. 142-50; garber, supra note 276, at 305; yoshino, supra note 277, at 40, 42-43. 295. see garber, supra note 276, at 305. 296. auden, supra note 285, at 81. 308 indiana health law review [vol. 19:275 harnesses and points to in the play to audience after audience, enduring as the play is from the elizabethan age to ours.297 this high view is precisely what makes the play coherent—without such a view, the play simply would not make sense. and yet it does make sense to us because the shocking shocks, the pathos resonates, and the wrong infuriates. if our reigning late-modern thought is one that denies this high view of the body and the person, our inner recognition that the bargained-for exchange of money for the pound of flesh in the merchant of venice is simply wrong betrays ourselves. when, in the courtroom scene, antonio is ordered to “lay bare your bosom” for the carving out of the pound of flesh298 and we hear sylock’s ready response, “ay, his breast. so says the bond, doth it not, noble judge? ‘nearest his heart’—those are the very words,”299 we can’t help but see that shylock’s stubborn demand is wrong. we can’t help but blanch at it. we can’t help but recoil. further, usury and breeding as a leitmotif is captured in shylock’s musing out loud of (and in the process comparing usury with) the ancient genesis story of jacob’s clever breeding techniques to amass his own wealth while working under laban.300 it is also captured in shylock’s lively line when he receives the news that his daughter jessica has eloped with lorenzo, taking her father’s money with her, “my daughter! o, my ducats! o, my daughter!”301 since one might say that both his daughter and his ducats are a result of breeding.302 breeding as a picture of shylock’s bond of the pound of flesh, but also as his flesh and blood in his offspring,303 has a discomfiting parallel to our own issue of breeding children304 with the less-than-kosher means of the gamete as the pound of flesh. b. the body, thus the person, as a (luxury) good in the exchange with bassanio about the loan, shylock says, “antonio is a good man.”305 here, there is a play on the word “good” in that it is the moral sense of the word that bassanio has in his mind, but the financial sense of the 297. will dahlgreen, shakespeare 400 years on: every play ranked by popularity, yougov (apr. 22, 2016, 3:21 am), https://yougov.co.uk/topics/lifestyle/articles-reports/2016/04/22/ shakespeare-400 (finding that among the british polled for the question of which of shakespeare’s plays they had read or seen, the merchant of venice was ranked fifth); david rooney, william shakespeare’s the merchant of venice, variety (sept. 6, 2004, 4:10 pm), https://variety.com/ 2004/film/awards/william-shakespeare-s-the -m erch an t -of -ven ice-1200531265/ [https://perma.cc/4h4c-jnlv] (“‘the merchant of venice’ is considered among shakespeare’s greatest plays . . . .” in an article discussing a 2004 film adaptation of the play). 298. shakespeare, supra note 276, act 4, sc. 1, l. 249. 299. id. act 4, sc. 1, ll. 249-51. 300. id. act 1, sc. 3, ll. 90-92; genesis 30:25-43; garber, supra note 276, at 305. 301. shakespeare, supra note 276, act 2, sc. 8, l. 15. 302. garber, supra note 276, at 306; see also kerrigan, supra note 286, at 158-60. 303. kerrigan, supra note 286, at 204-05. 304. see supra notes 170-98 and accompanying text. 305. shakespeare, supra note 276, act 1, sc. 3, l. 11. 2022] sperm and eggs in consideration of money 309 word that shylock has in his.306 thus, how antonio will be “good for the loan” can be understood as “good” or trustworthy security for bassanio,307 but also, grotesquely, as delivering the flesh as the “good” under the terms of the loan, expensive—a luxury, as it were—as it may be.308 the word play continues with the loan that shylock offers in “kind” and in “kindness”309 with the word also having a double meaning, that is, as the goodness of the creditor’s heart, and as the form of payment of antonio’s flesh, which would be “in kind” as opposed to money.310 the play brings out with clarity the grotesque reality of commodification of the body in a way that may jar us, in contrast to the more opaque, but i submit no less grotesque, reality of commodification in donor conception. shylock and antonio, like the seller and buyer of the gametes, are bound in what john kerrigan calls “the carnality of their legal bond,” because “their carnal bonds meshed with financial contracts.”311 in both cases, the reigning thought is that the body can be parceled out for payment.312 an astonishing line uttered by portia upon sweeping into the courtroom, disguised as the young doctor of law balthasar,313 is, “which is the merchant here, and which the jew?”314 it would be unthinkable that antonio and shylock would be hard to tell apart, since jews in that day were consigned to wearing the “jewish gaberdine,”315 a type of garment that is long and coarse,316 and because actors playing jews on the elizabethan stage customarily put on large noses and red wigs.317 (it is interesting to note that the english at the time would actually not have been familiar with the jews since jews were driven out of england in 1290 and were not allowed in the land again until cromwell was in power,318 so the representation of jews on stage would have been a powerful shaping force of the 306. see garber, supra note 276, at 297. 307. see id. 308. see id. 309. shakespeare, supra note 276, act 1, sc. 3, ll. 140, 176. 310. see garber, supra note 276, at 297. 311. kerrigan, supra note 286, at 175. 312. w. h. auden compares the different attitudes toward money in the merchant of venice and twelfth night. whereas people are careless and even carefree with money in the merchant of venice, they are world-weary and cynical about it in twelfth night, with “an awareness that services must be paid for, that people can be bought, and that money can get you what you want.” auden, supra note 285, at 154. one wonders whether an imprudent use of money in one may not lead to another, whether there may not be a discernable line from the merchant of venice to twelfth night in following the money, or more precisely, in following money’s dark purchase powers. 313. shakespeare, supra note 276, act 4, sc. 1, ll. 149-66. 314. id. act 4, sc. 1, l. 171; garber, supra note 276, at 308. 315. shakespeare, supra note 276, act 1, sc. 3, l. 111. 316. garber, supra note 276, at 308. 317. id. 318. auden, supra note 285, at 75. 310 indiana health law review [vol. 19:275 imagination.) marjorie garber astutely observes that portia is making a point here that the loan of three thousand ducats for a pound of flesh has made something similar out of the hitherto-different characters of shylock and antonio.319 likewise, in donor conception, might the privity of contract that binds both buyer and seller of gametes situate them similarly as ones who both treat the flesh and the person as commodities, and who both treat their own resulting children as commodities? one reading of the merchant of venice yields a view that antonio may not have taken seriously shylock’s bond of his pound of flesh, and so he does not go into the contract with eyes wide open of the possibility of being grievously injured or dead.320 on the one hand, unlike antonio, modern-day sperm and egg donors know that they are selling their flesh for some money. on the other hand, like antonio, they may not realize the full-blown implications of it—and the arguments in these pages are certainly made without supposing that those who donate their gametes do so with the calculated intent to injure their resulting children, or themselves. but as kenji yoshino points out, much as portia’s argument of “the blood spilled in acquiring the flesh” is implied in the enforcement of a bond of a pound of flesh for money,321 so it is implied in selling one’s gamete that the very purpose of the purchase by the buyer is to make children—of the seller’s own flesh and blood—out of the gamete. this flesh, unlike the flesh in the merchant of venice, meets with the other gamete and becomes a human being of his own, with questions, longing, and the desire to know and to be known. selling one’s flesh inescapably makes for a wound. it kills, even—“the murderous pound of flesh,” john kerrigan calls it.322 as g. k. chesterton writes of the merchant of venice, “the pound was a part of an organic life, and that in taking that [shylock] was in fact taking more.”323 but we have seen how the selling of flesh (one’s gametes) injures the resulting children most obviously. it might even kill in that it creates a kind of death: a void, a real loss in the children’s lives.324 portia is right after all. we can’t sell our pound of flesh—and blood, in that famous twist of the story. not without resulting in a death. 319. garber, supra note 276, at 308-09. 320. antonio assures bassanio about shylock, “the hebrew will turn christian; he grows kind.” shakespeare, supra note 276, act 1, sc. 3, l. 176; see garber, supra note 276, at 297. 321. see shakespeare, supra note 276, act 4, sc. 1, ll. 321-29; yoshino, supra note 277, at 44; see also kerrigan, supra note 286, at 204-05. 322. kerrigan, supra note 286, at 168. what is more, he says, “a forfeit can deny you life by taking that by which you live.” id. at 171. 323. g. k. chesterton, the pound of flesh, in the soul of wit: g. k. chesterton on william shakespeare 117, 119 (dale ahlquist ed., 2012). 324. just as it does not require payment of money for the taking of a pound of flesh to be injurious, so it does not require payment for a gamete for it to be injurious to the resulting child (or the donor). so it holds that even if the gamete is gifted to the recipient, with absolutely no money changing hands, it would still be harmful and thus inappropriate. see supra notes 190, 263 and accompanying text. 2022] sperm and eggs in consideration of money 311 to be sure, the analogy between the merchant of venice and donor conception breaks down at some point. of course the flesh in the merchant of venice is not something that needs something else to be yet something of an entirely different kind, as is true of a gamete that needs a gamete mate to become an embryo. the pound of flesh is, furthermore, useless to shylock,325 except in the sense that the taking of it would injure or kill antonio. yet the gamete is useful to the buyer, and any injury to donor and child is emphatically not intended. far from harboring malice, the actors in donor conception are most well-intentioned in their chosen course of action: the buyers want to have a baby, and the sellers want to help make that baby, even if money is involved. moreover, the poet w. h. auden observes that the different treatments of who was and was not allowed to transact with usury betray the ambivalence of a society that frowned on usury but whose members still needed to borrow money from creditors, who, due to the nature of the business, ended up being outsiders to society, as shylock was.326 but unlike shylock, the buyers in the market of gametes are not outsiders,327 at least in the financial sense, since these buyers tend to be the those with means and resources.328 (both gamete buyers and shylock do share the similarity of being in a position of having means.) but even with these limitations of analogy, the merchant of venice sheds light on donor conception in some poignant ways: the commodification of the body, and thus the person; the impropriety, the injustice, even the basic wrongness of that commodification; and how the taking of the flesh and blood injures and brings forth a loss, a wound, even a death. if we as a society commit to the proposition that our bodies be alienable, does that commitment not lead us to the selling of our pound of flesh and blood for money? if everything is truly up for sale and nothing is off limits, richard posner would be exactly correct that it is rather “puzzling from an economic standpoint” that one is not allowed to contract to sell himself into slavery, or that a husband cannot contract to kill himself in a fire in a funeral pyre for his wife, or that shylock is not allowed to enforce his bond of pound of flesh.329 in fact, shylock himself points out that for all the condemnation that the venetians direct at him for seeking enforcement of his bond of a pound of flesh, they themselves purchase slaves and work the slaves like animals.330 if the venetians were to be confronted of this wicked practice and demand were to be made of them to release their slaves, shylock, speaking to the venetians, makes the chilling argument that “you will answer, ‘the slaves are ours.’ so do i answer you. 325. shakespeare, supra note 276, act 1, sc. 3, ll. 164-66; kerrigan, supra note 286, at 162. 326. auden, supra note 285, at 79-80; see also garber, supra note 276, at 285-86. 327. see garber, supra note 276, at 285-86. 328. see supra note 14 and accompanying text. 329. richard posner, economic analysis of law 187 (1977); gordley, origins, supra note 45, at 235. 330. auden, supra note 285, at 80. 312 indiana health law review [vol. 19:275 the pound of flesh which i demand of him is dearly bought. ‘tis mine, and i will have it.’”331 vi. conclusion if the common good as the telos of law requires justice, and the telos of justice is human flourishing,332 then it makes sense that law ought to be for the sake of persons: for their good, for their flourishing.333 law is inextricable from morality,334 as morality is that dealing with care the question of human flourishing, considering integrally all the basic goods of human life.335 so the questions posed earlier of an “immoral object,” “harm to the soul,” or “safety of the body”336 in the doctrine of consideration within the context of donor conception can be answered as follows. a recovery of the principle of commutative justice in the doctrine of consideration would be a recovery of the importance of equal values being exchanged in a contract. a framework of law for the buying and selling of gametes is that of consideration, the freely bargained-for exchange between a “donor” for his or her gamete and buyers for their money. it is understood as the two parties’ atomized will to contract with each other, edging out careful thought of what it does to the “product” of the contract: not gametes changing hands to be left as gametes, but the child as an embodied being, along with his needs and natural rights, and what is owed to him that he may flourish.337 thus the body, even from the embryonic stage, is “recruited as instrumentalities” of the project of the assertion of the autonomous will, as “the body and its parts are explicitly 331. shakespeare, supra note 276, act 4, sc. 1, ll. 96-99. 332. see supra notes 49-50 and accompanying text. 333. finnis, supra note 268, at 22-23; snead, supra note 11, at 65, 68, 269. 334. a. w. brian simpson wrote of the connection between consideration and morality as follows, [t]he view that the law of contract is the handmaid of commerce seems to me to be mistaken if it is opposed to the view that the law of contract expresses, in a form thought appropriate (bearing in mind the practicalities of litigation), moral ideas. for commerce, like other areas of life, must be conducted morally if the general good is to be furthered and there is no special set of principles of commercial morality. the doctrine of consideration is indeed intensely moralistic, and we may disagree with some of its judgments; what is mistaken is to fail to see that a good law of contract has as its function in relation to the commercial world the imposition of decent moral standards. simpson, supra note 56, at 488 (emphasis added). thus to think of contracts as a product of the will only, severed from moral virtue, is to render the doctrine of contract law incoherent. gordley, origins, supra note 45, at 7-9. 335. finnis, supra note 51, at 38, 47; finnis, supra note 50, at 19-20; george, supra note 51, at 59; tollefsen, supra note 50, at 151, 153; supra note 51 and accompanying text. 336. see supra notes 70-71 and accompanying text. 337. see snead, supra note 11, at 70, 271; goldman, supra note 86; martineau, supra note 7. 2022] sperm and eggs in consideration of money 313 reduced to articles of commerce. people enter and exit intimate procreative relationships marked by contract and bargained-for exchange,” o. carter snead wrote.338 donor conception treats the body and the person as objects—our very own modern, grotesque version of a pound of flesh for three thousand ducats. but if commutative justice requires what it does, what hath donor conception wrought, for the donor and for the resulting child? should the body (or its parts) and thus the person be sold like goods, even if luxury goods? how could the human person ever rightly be reconciled as having “equal values” with money in the bargained-for exchange of the body for cash? is this not an “immoral object” spoken of as historically prohibited in consideration?339 and this, despite the worrisome health risks involved in the process necessary for donor conception, quite the concern apropos of “safety of the body” in consideration?340 should the seeds of our children be up for the exchange of money? and if we dare say yes to commodifying children, how much would be the appropriate sum? such commodification surely explains the price differentials in ivy eggs compared to other eggs. are we prepared to justify it? if we are, are some humans then of more worth than others? it is surely a slippery slope from here to the nazi’s lebensunwertes leben341 to aborting down syndrome babies in our day.342 or perhaps we are more like the venetian slave-owners whom shylock criticized343 than we are willing to admit. in contrast, if law ought to be for the sake of persons344 and persons are embodied beings, then, as o. carter snead exhorts, law “must begin with the meaning and consequences of embodiment.”345 the dignity of the person and what it means that he is an embodied person must be the starting point.346 they must be paramount.347 let it be emphasized again that the profound longing for a child is for a profoundly good thing, and the devastating pain of infertility is truly grave. but no one has a right to a child; rather, it is the child who has a right 338. snead, supra note 11, at 219. 339. supra notes 68, 70 and accompanying text. 340. supra notes 69, 71 and accompanying text. 341. j. daryl charles, lebensunwertes leben: the devolution of personhood in the weimar and pre-weimar era, 21 ethics & med. 41 (2005); robert jay lifton, german doctors and the final solution, n.y. times mag., sept. 21, 1986, at 64; adam s. cohen, harvard’s eugenics era, harv. mag. (mar.-apr. 2016), https://www.harvardmagazine.com/2016/03/harvards-eugenics-era [https://perma.cc/ru65-h442]. 342. ed gantt, abortion, down syndrome and eugenics, byu wheatley inst. (mar. 30, 2018), https://wheatley.byu.edu/abortion-down-syndrome-and-eugenics/# [https://perma.cc/9w24y2qk]. 343. shakespeare, supra note 276, act 4, sc. 1, ll. 96-99; see supra note 331 and accompanying text. 344. finnis, supra note 268, at 22-23; snead, supra note 11, at 65, 68, 269. 345. snead, supra note 11, at 222. 346. see id. at 223, 225-27. 347. id. 314 indiana health law review [vol. 19:275 to his father and mother.348 as painful as childlessness is, if donor conception commodifies the body and the person and unjustly creates bewilderment, fragmentation, loss, and woundedness in the child’s life—that “harm to the soul” spoken of earlier349—then donor conception ought not to be done. if gametes are being exchanged for money in the name of consideration in contract law, then such an exchange ought to be called out as unjust and immoral; it ought not to be recognized as proper. the body—both the donor’s and the child’s—in donor conception has become a means to an end. but no body, and thus nobody, should be treated as a means to an end, however good or noble or worthy the end. donor conception, helen m. alvaré writes, “jeopardizes the idea of parents as recipients of a very vulnerable gift, as lovers of an unknown person.”350 an examination of the framework of consideration in donor conception reveals an impoverished vision of what is owed to the characters involved in the story: the children and the donors in particular. the practice is ill-suited to, even unworthy of, each person’s inherent dignity. a way forward would be to stop allowing for the buying and selling of gametes in the name of consideration. in so doing, we would begin to make room for law that is oriented away from treating the body as a commodity and the child as something to which we are entitled; and toward proper respect of the person and the lovely posture of receiving each child as a gift.351 348. supra note 86 and accompanying text. 349. supra notes 69, 71 and accompanying text. 350. alvaré, supra note 32, at 54; see snead, supra note 11, at 100, 103. 351. see snead, supra note 11, at 100, 103, 224; alvaré, supra note 32, at 54; moschella, supra note 8; see also tollefsen, supra note 86. unaccountable care: the dangers of federal support for anticompetitive behavior in the healthcare market unaccountable care: the dangers of federal support for anticompetitive behavior in the healthcare market wesley moss * “most people do not like to compete, and will seek ways of avoiding competition by agreement tacit or explicit, depending of course on the costs of agreeing.” – judge posner, united states v. rockford memorial corp, 898 f.2d 1278, 1285 (7th cir. 1990). i. introduction in the ten years after the introduction of accountable care organizations (acos) into the healthcare marketplace, counties which have high aco adoption have seen a 4% increase in the number of large healthcare practices. 1 small physician practices have decreased by 2.7%. 2 these changes are difficult to conceptualize in the abstract, but the reality of the situation is that patients in these areas are suffering from the pitfalls of consolidation. 3 the aco program was supposed to save the taxpayer and medicare beneficiaries money by improving continuity of care. 4 healthcare providers have always struggled with coordination of care. 5 tracking a patient’s status from one appointment to the next is difficult, while tracking a patient’s progress from one healthcare entity to the next can be almost impossible. the obama administration sought to improve this issue by introducing the aco model in 2012.6 at its core, an aco is an operating agreement between healthcare providers to work cooperatively and take financial responsibility for the outcomes of their ————————————————————————————— * j.d. candidate, 2024, indiana university robert h. mckinney school of law; b.s., 2020, indiana university. the author extends special thanks to vice dean max huffman, the indiana health law review staff, his parents, debbie moss, john barton, and to his fiancé anahli patel for their support. 1. genevieve p. kanter et al., changes in physician consolidation with the spread of accountable care organizations, 28 health aff. 1936, 1940 (2019). 2. id. 3. id. at 1942 (“these patterns suggest that the consolidation concerns initially raised regarding acos were warranted and that gains from care coordination facilitated by acos will have to be balanced against higher prices and possibly lower-quality care that could result from consolidation.”). 4. elizabeth fowler et al., accountable care and accountable care organizations, ctr. for medicare & medicaid serv., https://innovation.cms.gov/key-concept/accountable-care-andaccountable-care-organizations [https://perma.cc/7ggx-dyv5] (last visited july 27, 2023). 5. care coordination, ctr. for medicare & medicaid serv., https://innovation.cms.gov/ key-concept/care-coordination [https://perma.cc/xr9c-5ma2] (last visited feb. 26, 2023). 6. tianna tu et al., the impact of accountable care: origins and future of accountable care organizations 3 (may 2015), https://www.brookings.edu/wp-content/ uploads/2016/06/impact-of-accountable-careorigins-052015.pdf [https://perma.cc/e54l-hd 8k]. https://perma.cc/e54l-hd https://www.brookings.edu/wp-content https://perma.cc/xr9c-5ma2 https://innovation.cms.gov https://perma.cc/7ggx-dyv5 https://innovation.cms.gov/key-concept/accountable-care-and indiana health law review [vol. 21:475 476 patients. 7 this value-based care means that the providers are reimbursed for quality of the care, not just for the quantity of care provided. 8 to assist the delivery of high quality care among member providers, the federal government gave aco members permission to share information regarding patients, pricing, and costs. 9 the guidance was removed in july 2023, reverting aco participants to the more general horizontal merger guidelines. 10 the information sharing of this arrangement is presents a strong risk of harm to competition.11 however, aco participants operate without fear of antitrust litigation because the federal government has given aco members an exemption from the normal antitrust rules. 12 with fewer unaffiliated community hospitals, and a rise in the number of healthcare large in 2021 and 2022, competition in the healthcare marketplace is at its tipping point.13 before the aco guidance was repealed, the question was why the federal government maintains support for an anticompetitive system? now that it has been repealed in its entirety, the question is what will the agencies replace their guidance with? a. the issue aco participation has been linked to a decline in the number of independent healthcare providers. small providers been replaced by larger healthcare networks. 14 the disappearance of the local provider has been one of the ————————————————————————————— 7. id. 8. id. 9. see generally, fed. trade comm’n & antitrust div. of dept. of justice, statement of antitrust enforcement policy regarding accountable care organizations participating in the medicare shared savings program 1 (2011), https://www. justice.gov/d9/atr/legacy/2011/10/20/276458.pdf [https://perma.cc/2vfj-y9ns] [hereinafter repealed aco guidelines]; see also u.s. dept. of justice & fed. trade comm’n, statements of antitrust enforcement policy in healthcare, antitrust div. u.s. dept. of justice 1 (aug. 1996), https://www.justice.gov/atr/statements-antitrust-enforcement-policyin-health-care [https://perma.cc/sy8v-u39e] [hereinafter repealed healthcare guidelines]. 10. federal trade commission withdraws health care enforcement policy statements, fed. trade comm’n (july 14, 2023), https://www.ftc.gov/news-events/news/press-releases/ 2023/07/federal-trade-commission-withdraws-health-care-enforcement-policy-statements [https://perma.cc/5n2x-m7pu]; see also justice department withdraws outdated enforcement policy statements, off. of pub. aff. u.s. dept. of justice (feb. 3, 2023), https://www.justice. gov/opa/pr/justice-department-withdraws-outdated-enforcement-policy-statements [https:// perma.cc/hu4w-tbas]. 11. federal trade comm’n & dept. of justice, horizontal merger guidelines 34 (aug. 19, 2010), https://www.ftc.gov/legal-library/browse/horizontal-merger-guidelines-unitedstates-department-justice-federal-trade-commission [https://perma.cc/kut3-ba4r]. 12. repealed aco guidelines, supra note 9, at 6 (establishing the “safety zone” for acos). 13. sherry a. glied & stuart h. altman, beyond antitrust: health care and health insurance market trends and the future of competition, 36 health aff. 1572, 1572 (2017). 14. kanter et al., supra note 1, at 1940. https://perma.cc/kut3-ba4r https://www.ftc.gov/legal-library/browse/horizontal-merger-guidelines-united https://www.justice https://perma.cc/5n2x-m7pu https://www.ftc.gov/news-events/news/press-releases https://perma.cc/sy8v-u39e https://www.justice.gov/atr/statements-antitrust-enforcement-policyin-health-care https://perma.cc/2vfj-y9ns https://justice.gov/d9/atr/legacy/2011/10/20/276458.pdf https://www 2024] unaccountable care 477 hallmarks of aco adoption. 15 with cost savings usurping the previous goal of patient outcomes, there is a new incentive to merge. without any further intervention by regulators, the taxpayer will be left holding the bag for the unnecessary increases in healthcare costs. 16 the new guidance, if there is any, must keep a closer eye on acos and remove parts of their antitrust exemptions, so that the benefits of the aco model can be kept, without its negative sideeffects. to counteract the growing trend of conglomeration of aco participants, the federal and state governments have a duty to scrutinize the mergers and acquisitions of aco participants. this requires a three-pronged approach: first, the agencies must issue new guidance redefining the amnesty granted to acos which takes into consideration the merger of former aco participants. second, the new guidance must strip aco participants of their automatic “rule of reason” treatment. the regulating agencies need to take advantage of tools like “quick look” analysis for any aco merger. third, the courts must accept the agencies’ guidance and interpret an aco merger under the “quick look” standard to ensure that aco dominated markets remain competitive. b. roadmap this note is an analysis of anticompetitive effects accountable care organizations have had on the communities they serve. section ii provides background information to contextualize the issue. it begins with an explanation of healthcare antitrust concepts and relevant caselaw for this issue. section ii also explains the origins of the aco scheme and the subsequent implementation by the affordable care act. section iii will compare and contrast the positive patient care effects of acos with the negative anticompetitive results. then the note will turn to how the federal guidance for acos can be improved and changed. the note will argue that although the aco scheme’s success at achieving the triple aim of healthcare, it cannot continue without intervention from the federal and state governments. next, the note will change course and look prospectively at upcoming changes to the aco program and discuss the validity of criticism from politicians and policymakers. finally, section iv will summarize the findings and assert that based on the sum of the evidence new guidance must be promulgated, or else the aco program will lead to worse outcomes for patients and taxpayers. ————————————————————————————— 15. id. at 1936 (“a 4.0-percentage-point increase in large practices (those with fifty or more physicians) in counties with the greatest aco penetration, compared to counties with zero aco penetration, and a 2.7-percentage-point decline in the percentage of small practices (ten or fewer physicians) from 2010 to 2015.”). 16. how is medicare funded?, medicare.gov, https://www.medicare.gov/about-us/how-ismedicare-funded [https://perma.cc/s8sg-7twf] (last visited feb. 26, 2023). https://perma.cc/s8sg-7twf https://www.medicare.gov/about-us/how-is https://medicare.gov indiana health law review [vol. 21:475 478 ii. background a. antitrust statutory framework antitrust is the field of law which deals with how the government protects and promotes competition in the name of consumer welfare. 17 this area was developed during the gilded age when anticompetitive behavior grew to untenable levels. 18 since then, it has adapted to the changes in the economy by lawsuits brought by the federal and state governments, as well as by individuals asserting their own private rights of action.19 at the federal level antitrust enforcement is handled by two agencies, the department of justice and the federal trade commission. these two agencies are guided and authorized by the sherman antitrust act and the clayton antitrust act.20 the agencies enforcing the laws act in conjunction with one another and protect consumers from the dangers of anticompetitive behavior. 21 the first section of the sherman antitrust act prohibits any conduct by two or more persons that “produces anticompetitive effects outweighing any procompetitive effects stemming from the agreement.”22 the second section prevents “unilateral conduct” to monopolize a specific industry. 23 the third section prevents independent industry participants from making contractual agreements with competitors to do things like fix prices. 24 the clayton act built on the sherman act by expanding the definition of anticompetitive behavior to include specific business practices. 25 these specified five practices which were prohibited: (1) price discrimination, (2) tying arrangements, (3) exclusive dealings contracts, (4) anticompetitive mergers and acquisitions, and (5) interlocks of directors and certain officers. 26 these enumerated practices put teeth in the government’s enforcement efforts. 27 before this, there was relatively little that the government could do to prevent anticompetitive behavior.28 ————————————————————————————— 17. phillip e. areeda & herbert hovenkamp, antitrust law: an analysis of antitrust principles and their application § 100 (5th ed. 2022). 18. see generally id. at § 101. 19. id. at § 100. 20. see generally 15 u.s.c. §§ 2, 18-25. 21. areeda & hovenkamp, supra note 17, at § 2400 (state law generally tracks the federal government closely, with some even adopting statutes that makes federal jurisprudence binding on the state. in most states, the attorney general is tasked with enforcing the antitrust laws, however, due to practical concerns, state enforcement is relatively rare.). 22. sherman antitrust act, 26 stat. 209 § 1 (1890). 23. 15 u.s.c. § 2; see also areeda & hovenkamp, supra note 17, at § 914 (defining “unilateral conduct”). 24. see generally 15 u.s.c. §§ 2, 18-25. 25. see generally 15 u.s.c. §§ 18-25. 26. id. 27. areeda & hovenkamp, supra note 17, at § 101. 28. id. 2024] unaccountable care 479 of importance for this note is the clayton act’s prohibition on anticompetitive mergers and acquisitions. a merger, like any business practice, is anticompetitive if its effect “may be substantially to lessen competition or to tend to create a monopoly.”29 b. antitrust standards of review the caselaw on antitrust is vast, but for the purpose of acos, there are three relevant standards of analysis for a potentially anticompetitive merger or acquisition: per se analysis, rule of reason analysis, and quick look analysis. 30 per se analysis has limited in its application by the supreme court, however some lower courts still favor it. 31 this note will focus on rule of reason analysis and quick look. the basic requirement of the rule of reason approach is that the plaintiff must show that there is no competitive purpose reasonably accomplished by the defendant’s anticompetitive behavior.32 “rule of reason” analysis must be done on a case-by-case basis and requires an in-depth market analysis. 33 market analysis requires an understanding of the market size and the market dominance of the defendant business. 34 as with many things, this seems simpler than it is. the requirement of a market analysis can be the death knell for an otherwise successful antitrust lawsuit. 35 also, the burden placed on the plaintiff is heavy. proving that there is an anticompetitive behavior in the first place can be difficult. 36 for instance, consider a regulator attempting to pre-emptively block a merger of two widget manufacturers. the regulator must not only show that the widget market would be dominated by the merged entity, but that the market dominance would not have otherwise happened without the merger.37 this is a tremendous task requires an analysis of the relevant market’s size, the competitors in the market, trends in the market, differences in the widgets produced, etc. a market analysis like this has extremely high financial and time costs to the point that it disincentivizes regulators from regulating. placing the market analysis ————————————————————————————— 29. 15 u.s.c. § 18. 30. areeda & hovenkamp, supra note 17, at §§ 1500-12. 31. see generally id. at § 1500 (per se analysis requires that if an activity violates an enumerated prohibition in the antitrust laws, then the court must find it illegal per se. however, this rigid enforcement has fallen out of favor with courts which see the enforcement as a negative. courts favor rule of reason for its more flexible approach to the law.). 32. id. at § 1508. 33. id. (“like all such general standards, reasonableness varies not only with the circumstances but also with the purpose of the inquiry.”). 34. matthew lane, antitrust in 60 seconds: market definition, disruptive competition project (sept. 5, 2018), https://www.project-disco.org/competition/090518-antitrust-in-60seconds-market-definition/ [https://perma.cc/su6h-d5aj]. 35. id. 36. id. 37. id. https://perma.cc/su6h-d5aj https://www.project-disco.org/competition/090518-antitrust-in-60 indiana health law review [vol. 21:475 480 requirement on the regulator, or the plaintiff, means that the party with the least amount of information carries the heaviest burden. some courts have avoided rule of reason analysis in scenarios where a person with “even a rudimentary understanding of economics” could look at a proposal and determine that it would be anticompetitive. 38 in those cases, the court could opt for a “quick look” analysis of the anticompetitive behavior. 39 this standard resembles per se in its straightforward application to the facts of the case, but maintains aspects of the rule of reason balancing test. 40 but it is not as unyielding as per se because it requires that the anticompetitive behavior be so egregious and its effects be so obvious, that anyone would agree that there was a problem.41 to consumer protection activists, the quick look approach is enticing because it solves the burden of market analysis requirements. it places the burden of proof on the defendant, who would have the information necessary to prove that a potential action is not anticompetitive. 42 quick look accelerates litigation and reduces the financial costs for the regulator or the individual seeking to enforce the antitrust law. 43 simply put, the quick look analysis puts the burden of information where it can best be borne, on the defendant. 44 so, in industries like healthcare where performing market analysis is especially difficult the quick look standard is ideal. it saves the plaintiff time and money by not having to prospectively find anticompetitive behavior, while providing the defendant the opportunity to show that their merger will be good for the consumer. 45 this does not mean that the quick look analysis is perfect, there certainly are questions of judicial fairness. however, it is important to understand that the quick look is not a “guilty until proven innocent” framework. instead, it places a high bar for a prima facie showing that anticompetitive behavior will take place, and then shifts the burden of proof onto the defendant. this style of burden-shifting is common throughout the law and is not a novel concept.46 ————————————————————————————— 38. cal. dental ass’n v. ftc, 526 u.s. 765, 770 (1999). 39. areeda & hovenkamp, supra note 17, at § 1911. 40. id. 41. cal. dental ass’n, 526 u.s. 765, 770 (1999). 42. ftc v. indiana fed’n of dentists, 476 u.s. 447, 459 (1986); see also cal. dental ass’n v. ftc, 526 u.s. 765, 780 (1999) (a quick look can be applied in the “twinkling of an eye”). 43. areeda & hovenkamp, supra note 17, at § 1911. (“the inquiry can be severely truncated when the restraint is sufficiently threatening to place it in the presumptively per se class”). 44. id. (“with power and highly likely anticompetitive effects established, the burden would better have been placed on the defendant to justify its restraint.”). 45. id. 46. id. 2024] unaccountable care 481 c. federal guidelines statutes and caselaw have the final say in whether an activity is anticompetitive, but the regulators have made their enforcement practices known to the public. the department of justice and the federal trade commission have published “guidelines” which describes the enforcement measures taken by the federal regulators. 47 these guidelines have not gone through any federal rulemaking process so they are not binding on any party, even the agency that wrote them. 48 however, they are highly persuasive on courts and offer information to regulated industries to ensure that they are not violating antitrust law. for our purposes, there are three guidelines which will be important to understand. the first is the horizontal merger guidelines which describe the agencies’ position on mergers and acquisitions of businesses in all industries. 49 this guidance describes how the federal trade commission will treat horizontal integration, i.e. one company purchasing another in the same market. 50 these guidelines are not perfect; however, they serve an important role in helping regulated industries remain compliant with antitrust law. one pro-consumer criticism is that the guidelines do not address small-market or “roll-up” mergers, but recent policy changes show that the agencies are focusing more of their attention on these issues. 51 however, the merger guidelines have been successful at helping industry participants remain compliant with one another. 52 the second are the healthcare guidelines. 53 although recent critics have called it into question, the traditional thinking was that healthcare was a unique market, not subject to traditional economic principles. 54 this is reflected in antitrust, and as such regulators believed healthcare deserved its own antitrust guidance. 55 the statement itself does not differ in many ways from the general ————————————————————————————— 47. see generally repealed aco guidelines, supra note 9, at 2; see also federal trade commission withdraws health care enforcement policy statements, supra note 10 (for another ftc guideline). 48. ftc publishes final guides governing endorsements, testimonials, fed. trade comm’n (oct. 5, 2009), https://www.ftc.gov/news-events/news/press-releases/2009/10/ftcpublishes-final-guides-governing-endorsements-testimonials [https://perma.cc/cut2-xx2l]. 49. u.s. dept. of justice & fed. trade comm’n, horizontal merger guidelines 1 (aug. 19, 2010), https://www.ftc.gov/system/files/documents/public_statements/804291/100819 hmg.pdf [https://perma.cc/6gah-r23u]. 50. areeda & hovenkamp, supra note 17, at § 900 (contrast this with a vertical merger where a company purchases the business which provide the services necessary for the business). 51. fed. trade. comm’n, file no. p110014, statement of commissioner rohit chopra regarding private equity roll-ups and the hart-scott rodino annual report to congress (2023), https://www.ftc.gov/system/files/documents/public_statements/1577783/p110 014hsrannualreportchoprastatement.pdf [https://perma.cc/a83a-49yy]. 52. id. 53. repealed healthcare guidelines, supra note 9, at 1. 54. amitabh chandra et al., healthcare exceptionalism? performance and allocation in the u.s. healthcare sector, 106 am. econ. rev. 2110, 2110 (2015). 55. repealed healthcare guidelines, supra note 9, at 1. https://perma.cc/a83a-49yy https://www.ftc.gov/system/files/documents/public_statements/1577783/p110 https://perma.cc/6gah-r23u https://www.ftc.gov/system/files/documents/public_statements/804291/100819 https://perma.cc/cut2-xx2l https://www.ftc.gov/news-events/news/press-releases/2009/10/ftc indiana health law review [vol. 21:475 482 horizontal and vertical guidelines. however, the general guidance is lacking for the healthcare market in a few key areas. healthcare systems typically place competitors in situations where collaboration is highly incentivized, if not mandatory, so the horizontal guidelines prohibition on information sharing or pricing may not be applicable. what the healthcare guidelines did is carve out specific “zones of safety” for healthcare entities. 56 specific examples include language on competitor collaboration in joint ventures, information sharing, and mergers in specific markets.57 again, these markets are not perfect and leave a lot of wiggle room for anticompetitive behavior, but they serve a crucial role in setting the black and white rules for what activities will and will not be condoned by the regulating agencies. the third is the aco guidelines which will be described in length later in this section. 58 these guidelines provide aco participants with easy-to-follow instructions on remaining compliant with the antitrust law. 59 both the aco guidelines and the healthcare guidelines were repealed by the doj and the ftc in july of 2023. the ftc cited to the fact that the guidelines were “outdated.” instead of “rely[ing] on outdated guidance, the commission will rely on general principles of antitrust enforcement.”60 the “general principles” which the federal trade commission refers to here are likely their guidance for horizontal mergers, as well as interpretations from the courts regarding the sherman, clayton, and federal trade commission acts. although repealed, the guidance is still crucial to understand because it gives an indication for how the agencies thought about the healthcare marketplace. prior to their repeal the healthcare market was a unique marketplace necessitating its own regulations. now, the agencies seem to be taking an approach which de-prioritizes the healthcare market’s unique characteristics. now, the agencies are treating the markets for hospitals the same as markets for hotels. at least in the case of acos, this could prove to be incredibly troubling. all guidelines are not binding on the states or on private rights of action. 61 even if the guidelines allow an anticompetitive behavior individuals or state governments are not bound by the guidelines. in practice claims from individuals which conflict with the guidelines are not rare and serve as an effective tool for enforcement of antitrust principles. in fact, the supreme court has held that the antitrust laws are formed to allow people to serve as their own “attorneys general” to enforce the law. 62 ————————————————————————————— 56. id. at 5. 57. id. 58. repealed healthcare guidelines, supra note 9, at 5. 59. id. at 8, 13-14. 60. federal trade commission withdraws health care enforcement policy statements, supra note 10. 61. federal trade comm’n & dept. of justice, supra note 11, at 1 (guidance is not binding on the federal regulators since it did not go through notice and comment. however, it is relevant to courts.) 62. hawaii v. stand. oil co. of cal., 405 u.s. 251, 262 (1972). 2024] unaccountable care 483 d. healthcare antitrust competition in the healthcare industry is difficult to address succinctly. scholars and regulators agree that competition is necessary in the healthcare market because it leads to lower price and higher quality. 63 but difficulty in defining the healthcare marketplace is what leads to debate among antitrust and healthcare scholars. is choice really a factor in determining where someone gets their care? what about in an emergency, does the patient really have any choice of what hospital to go to? these questions go beyond the topic of this note and have been addressed previously by the courts and scholarship, 64 but they are constantly in the background when discussing a healthcare antitrust issue. a few key concepts will help guide our analysis of the aco mergers. first, non-profit hospitals are just as subject to antitrust law as for-profit hospitals. 65 although a healthcare entity is more likely than not a non-profit institution, they are still subject to antitrust laws. 66 there had been some debate as to whether the two antitrust acts were applicable to non-profit hospitals since non-profits do not have stock. 67 this lack of ownership of a nonprofit gave some hospitals the impression that they could avoid antitrust laws. 68 in united states v. rockford memorial corporation, the 7 th circuit court of appeals rejected that argument. 69 the court reasoned that there was nothing about the non-profit structure which made it more likely to compete “vigorously” than a for-profit business. 70 the argument that the non-profit hospitals have no stock was also not persuasive, since the sherman act puts a blanket restriction on business behavior which is in restraint of trade.71 thus, antitrust laws are just as applicable to nonprofit hospitals as their for-profit counterparts. 72 just because the organizations are subject to the non-distribution principle, and thus assets cannot be held in stock, is not an excuse to avoid application of the antitrust laws.73 ————————————————————————————— 63. competition in the health care market, fed. trade comm’n., https://www.ftc. gov/advice-guidance/competition-guidance/industry-guidance/competition-health-caremarketplace [https://perma.cc/7ula-9sz4] (last visited nov. 19, 2022) (however, the argument that a consolidation in the healthcare marketplace is good is certainly common). 64.karyn schwartz at al., what we know about provider consolidation, kff (sept. 2, 2020), https://www.kff.org/health-costs/issue-brief/what-we-know-about-provider-consolida tion/ [https://perma.cc/yd5w-pphy] (addressing health care market consolidation and high prices); see also emily gee & ethan gurwit, provider consolidation drives up healthcare costs, cap20 (dec. 5, 2018), https://www.americanprogress.org/article/provider-consolidationdrives-health-care-costs [https://perma.cc/r47y-276m]. 65. see u.s. v. rockford memorial corp., 898 f.2d 1278, 1285 (7th cir. 1990). 66. id. 67. id. 68. id. 69. id. 70. id. 71. id. 72. id. 73. id. https://perma.cc/r47y-276m https://www.americanprogress.org/article/provider-consolidation https://perma.cc/yd5w-pphy https://www.kff.org/health-costs/issue-brief/what-we-know-about-provider-consolida https://perma.cc/7ula-9sz4 https://www.ftc indiana health law review [vol. 21:475 484 second, a competitive healthcare market is one with multiple diverse players, that promote high quality care, and keep the costs down to attract new clientele. 74 thus, an effective and competitive healthcare market will satisfy the so-called triple-aim of healthcare. this triple aim is “(1) improving the individual experience of care; (2) improving the health of populations; and (3) reducing the per capita costs of care for populations.”75 a noncompetitive healthcare market will not achieve these gains since a noncompetitive market results in higher costs and worse quality of care. 76 this theory has been proven true in multiple studies with many demonstrating that the triple aim of healthcare is seriously impaired by consolidation and other anticompetitive behavior.77 third, the history of implementation of antitrust law in the healthcare marketplace is vast and we will only touch on a small but crucial moment in it: the prohibition on clinician managed care. in the 1950s healthcare providers were beginning to get frustrated with the relatively new system of health insurance payors. 78 to the providers, it seemed like the health insurance system took care out of the hands of providers and into the hands of the insurance companies. the insurers could determine where someone went to receive treatment and how much the procedure would cost. some providers took action on their belief that they should be making billing decisions instead of an actuary who had never practiced medicine. 79 they formed foundations for medical care (fmcs) which would negotiate price ceilings among all providers in a geographic area. 80 in consideration of paying their premiums, member-patients of these foundations would be provided healthcare services for no additional cost and the provider would be paid a flat fee described in their plan. 81 at first this model was successful at containing costs for patients, many patients received treatment at lower prices than they would pay if they were part of a “traditional” insurance plan.82 however, once some fmcs grew too large and began increasing premiums simply to increase the payment to the provider, regulators got involved. 83 the regulators argued that these horizontal price-fixing schemes were per se violations of the clayton and sherman acts. 84 in the eyes of regulators, an ————————————————————————————— 74. competition in the health care marketplace, supra note 58; see also discussion of the triple aim of healthcare, infra section iv. 75. berwick et. al. the triple aim: care, health, & cost, 27 health aff. 1, 1 (may/june 2008). 76. competition in the health care marketplace, supra note 58. 77. id. 78. donald c. harington, foundations for medical care, 170 j. am. med. ass’n 969, 96970 (1959) (discussing the creation of foundations for medical care). 79. see ariz. v. maricopa county medical soc., 457 u.s. 332, 351 (1982). 80. id. at 337. 81. id. at 341. 82. id. 83. id. 84. id. 2024] unaccountable care 485 fmc was a restraint on commerce. 85 arizona v. maricopa county medical society was a pivotal decision for fmcs and eventually acos. 86 in that case, the supreme court found that fmcs were a per se violation of the antitrust acts and must be barred by law. 87 although the foundations set price ceilings, the court still saw them as an unfair restraint on commerce. 88 in a 4-3 majority opinion, justice stevens refused to interpret the business structure under the rule-of reason. 89 instead, the court opted for a per se approach which invalidated the fmc model. 90 further, the court gave little credence to the argument that since fmcs were procompetitive, holding that the fmcs had failed to demonstrate their procompetitive benefits sufficiently to overcome a pro se analysis.91 this case demonstrated that the court does not interpret a horizontal price ceiling any different than horizontal price floors. 92 had the court applied the rule of reason in maricopa, it would have been required to prove that the price ceiling was not reasonably necessary to keep costs down. 93 the fmc argued that the organization could not have existed without the price-ceiling.94 thus the harsh result of the maricopa decision calls into question the use of per se analysis in a healthcare antitrust action. putting the correctness of the maricopa decision aside the reality today is that a program like an fmc is an illegal restraint on trade. 95 yet, if we compare an aco to the fmc in maricopa, the structures are almost identical. both are a group of providers, sharing information, setting prices, and negotiating with payors as an organization. this begs the question: how are accountable care organizations allowed to exist when the supreme court explicitly banned that structure in the 1970s? the short answer: the government has agreed to look the other way in exchange for cost-savings.96 ————————————————————————————— 85. id. 86. id. at 332. 87. id. 88. id. 89. id. 90. id. 91. id. 92. id. 93. id. 94. id. 95. id. 96. see generally repealed aco guidelines, supra note 9, at 2, 6; see also andrew a. kasper, comment, antitrust review of accountable care organizations: an assessment of ftc and doj’s relaxed approach to regulating physician-hospital networks, 90 n.c. l. rev. 203, 203 (2011). indiana health law review [vol. 21:475 486 e. aco history in the 2000s cms was exploring new methods to respond to the neverending public backlash to managed care. 97 unsure of what would work, cms turned to experimenting with “demonstrations” in small markets across the country. these demonstrations included new and untested techniques for controlling healthcare cost. 98 in 2006 cms hypothesized the basis for the aco program; if financial risk for patient outcomes was placed on providers, then providers would help keep costs down and deliver higher quality care. 99 to test their hypothesis, cms formed the medicare physician’s group practice (pgp) demonstration project to pilot a program of rewarding physicians for taking on risk. 100 providers would be paid bonuses if they were able to make efficiency gains and improve quality in any of the thirty-two predetermined care measures. 101 the pgp demonstration ended in 2010 and was generally successful at accomplishing its cost and quality goals. 102 the lessons learned from the pgp demonstration would be incorporated into the affordable care act.103 the aca included a provision to allow cms to create a system of reimbursement for acos. 104 the statute permitted providers to form contractual obligations with one another and to share information regarding patient care and risk. 105 the aco model would, in theory, take the benefits of a consolidated healthcare system while avoiding the results of anticompetitive mergers and acquisitions.106 the aca created two types of accountable care organizations: public and commercial. 107 public accountable care organizations are those which participate in the medicare shared savings program (mssp). 108 the mssp is a carrot and stick approach to ensure cost efficient care and quality outcomes. if an accountable care organization can reach the benchmarks, then they will be rewarded with a payment which is distributed to participants. 109 however, if the aco falls short of their goal then the participants are penalized and must pay cms back for their ————————————————————————————— 97. tu et al., supra note 6, at 2. 98. id. 99. id. 100. id. 101. id. (this is known as “benchmarking” the acos). 102. id. 103. id. 104. patient protection & affordable care act, pub. l. no. 111-148, 124 stat. 119, 395 (2010). 105. id. 106. repealed aco guidelines, supra note 9, at 2-3. 107. id. 108. id. 109. 42 c.f.r. § 425.20 (2011) (“shared losses means a portion of the aco’s performance year medicare fee-for-service parts a and b expenditures, above the applicable benchmark, it must repay to cms.”). 2024] unaccountable care 487 failure.110 f. how the government preemptively addressed the antitrust concerns with acos. scholars were concerned that two features of acos would encourage anticompetitive behavior, particularly price-fixing. 111 first, the aco participants can share information with one another regarding price. 112 second, the participants can negotiate collectively for reimbursement. 113 the aco scheme is almost identical to that in maricopa.114 they both include physician-managed pricing and information sharing. 115 the reason why an aco is permitted to exist while an fmc cannot is simple, the ftc and doj have ruled—preemptively—that the sharing agreements are reasonably required to accomplish the goals of the aco. 116 so, the issue has never actually reached the courts to decide if an aco is an illegal restraint on trade. 117 instead, the preemptive permission has resulted in the government not enforcing the antitrust law against acos.118 to instill confidence in the accountable care model, the cms partnered with the ftc and the doj to craft policy which would require the three agencies to work together to keep a close eye on accountable care organizations. 119 the agreement between the agencies required that cms craft policy which will ensure that the acos will stay competitive and not devolve into price-fixing schemes. 120 ————————————————————————————— 110. id. at § 425.112(a)(3)(i). see also cms, shared savings and losses and assignment methodology (2022). the program increases reimbursement to providers who agree to take on more financial risk. id. at 52. providers who take on no risk can still benefit from the mssp but at a significantly reduced rate. id. at 56. (level a & level b (one-sided model)). 111. kasper, supra note 97, at 226. 112. tu et al., supra note 6, at 2. 113. id. 114. compare patricia m. bruns, note, accountable care organizations: 2012 symposium comments: an antitrust analysis of accountable care organizations: potential abuses from allowing reduced scrutiny under the affordable care act, 28 j. contemp. health l. & pol’y. 268, 269 (2012) (“acos will consist of competing providers who will work together to deliver care in a more coordinated, efficient, and cost effective manner and will “negotiate contracts on behalf of their participating providers including price terms.”) with ariz. v. maricopa county medical soc., 457 u.s. 332, 335-336 (1982) (“agreements among competing physicians setting, by majority vote, the maximum fees that they may claim in full payment for health services provided to policyholders of specified insurance plans.”). 115. repealed aco guidelines, supra note 9, at 2-3; see also tu et al., supra note 6, at 2. 116. repealed aco guidelines, supra note 9, at 2-3 117. but see sidibe v. health, 4 f. supp. 3d 1160, 1177-78 (n.d. cal. 2013) (dismissing a case against an accountable care organization in part because the court applied the rule of reason instead of per se analysis). 118. repealed aco guidelines, supra note 9, at 2-3. 119. kasper, supra note 97, at 207. 120. id. indiana health law review [vol. 21:475 488 striking this balance between the antitrust agencies’ desire to protect competition and the cms’ desire to reduce healthcare costs was contentious. 121 however, the respective agencies eventually found a happy medium. in the end, the antitrust agencies preemptively applied the rule of reason to the accountable care organizations. 122 this more forgiving standard of review was necessary because their structure would be a per se violation of the two antitrust acts. despite using a more relaxed standard for review, the agencies put limits on the acos in the “zone of safety.” notably, exclusive acos cannot become a dominant market participant, meaning that no one participant of an aco can control more than 50% of their relevant market and be exclusive to the aco. 123 additionally, the participants cannot share “competitively sensitive information” with one another. 124 unpacking those two exceptions is important. relevant market share is defined as the geographic area in which a customer, in this case a patient, may access services. 125 for instance, if the geographic area was defined as “marion county, indiana” and there were two providers, say dentists, then each dentist would control 50% of the relevant market. if there were three providers, then they would each control 33% of the market. if one of the dentists in this example were to have purchased one of the other two dentists in marion county and then join an aco, they would be deemed to be preemptively in violation of federal antitrust law because they control more than 50% of the relevant market. clinicians in the same market who practice in the same medical specialty are competitors. for instance, dermatologist a in the same market as dermatologist b are competitors. an aco, operating within the guidelines, can have both dermatologist a and b in the same organization. this collaboration means that participants are at risk for anticompetitive behavior in their relevant market. thus, the guidance would not allow any single aco participant from controlling more than 50% of a relevant market. 126 similarly, the acos were allowed to share information with each other subject to limitation.127 if information could lead to opportunities for collusion on issues of price or output, it is “competitively sensitive.”128 this would seem to be a strict standard to place on acos since the sharing of any patient or pricing information would seem to lead to the opportunity for collusion. however, the guidance recognized this and only limits the sharing of ————————————————————————————— 121. bruns, supra note 109, at 269. 122. repealed aco guidelines, supra note 9 at 4. 123. id. 124. id. 125. competition and monopoly: single-firm conduct under section 2 of the sherman act: chapter 2, u.s. dep’t of just. (mar. 18, 2022), https://www.justice.gov/archives/atr/ competition-and-monopoly-single-firm-conduct-under-section-2-sherman-act-chapter-2 [https:// perma.cc/7t2q-y7xa]. 126. repealed aco guidelines, supra note 9, at 9. 127. id. at 10. 128. id. at 63. https://www.justice.gov/archives/atr 2024] unaccountable care 489 competitively sensitive information if it is related to business “outside the aco.”129 so, if the information is not related to the aco, then the competitively sensitive information cannot be shared. 130 by way of example, if one dermatologist aco participant were to send information regarding the number of medicare patients that he or she was seeing this month, and what the prices he or she was paying for supplies to serve those patients to the aco members, it would not violate the guidance. however, if the dermatologist sent the aco members information regarding all (i.e. nonmedicare beneficiaries) of his or her patients seen at the clinic and the costs to serve those patients, then it would have violated the guidance.131 the reasoning behind the ban on sharing competitively sensitive information regarding outside-aco business is that the regulators are concerned with competitors knowing each other’s pricing and output information. 132 since the aco model requires reporting of pricing and cost, the agencies acquiesced to the cms and allowed the sharing of competitively sensitive information only when it involves aco patients. 133 if all competitively sensitive information was banned from being shared, then the aco would never be able to report to the cms the amount of money they saved or how many patients they saw. neither the 2010 nor the 2023 horizontal merger guidelines are express regarding the sharing of competitively sensitive information. it does speak to the danger of sharing this information with a competitor when merging and will likely interpret the share of competitively sensitive information under a rule of reason approach. however, the ftc has prosecuted cases against merging firms for sharing competitively sensitive information under §1 of the sherman act. so, how harshly the ftc will enforce this issue on aco participants will need to be seen, due to the lack of current guidance. g. criticism at the following aco implementation after the introduction of acos, the program was subject to a dearth of literature and scholarship, both legal and otherwise. skeptics anticipated that the federal government would struggle to define and implement regulations which would actually keep costs down and quality up. 134 proponents anticipated that they would be the future of healthcare. further, they predicted that the guidance passed by the regulatory agencies would be insufficient at ensuring that the anticompetitive qualities inherent in the accountable care model would not ————————————————————————————— 129. id. at 167. 130. id. at 99-100. 131. id. 132. e. john steren, antitrust compliance and exchanges of competitively sensitive information three situations in which access can lead to antitrust concerns and possible safeguards for each, 21 j. health care compliance 61, 61 (2019). 133. see generally tu, supra note 6. 134. see bruns, supra note 109. indiana health law review [vol. 21:475 490 raise their ugly head and destroy any good qualities. 135 the concerns echoed those of the supreme court in the maricopa county decision. 136 many worried that the acos would be encouraged to set price ceilings with one another since they negotiate together and share price information. specifically, there was concern that the government had not adequately defined the limitations of the aco, and that anticompetitive behavior by aco participants would be the result. 137 h. the future of acos: the reach model in august of 2022, the centers for medicare and medicaid services published a proposed rule change to the mssp which introduced the aco realizing equity, access, and community health (aco reach) plan. 138 the proposal would increase payments to acos participating in the mssp, increase aco participation of mental health professionals, and increase aco participation in underserved communities. 139 the agencies were encouraged to do this because of demonstrations by different aco groups and claims that acos were not equitably available to all medicare enrollees. 140 also, the cms saw that retaining aco participants would only be possible if the agency increased the shared savings payments. 141 so, by increasing aco payments, cms is hoping that they will encourage more providers to join the aco model. 142 while the increase in payments will reduce the net cost savings from mssp participants, the increase in quality care across the nation will hopefully result in fewer visits to providers and better outcomes for medicare enrollees. 143 ————————————————————————————— 135. id. 136. see generally tu, supra note 6. see also bruns, supra note 109. 137. see generally julia kapchinskiy, the duality of provider and payer in the current healthcare landscape and related antitrust implications, 55 san diego l. rev. 617, 652 (2018). see also shaun e. werbelow, rule of reason without a rhyme: using “big data” to better analyze accountable care organizations under the medicare shared savings program, 90 nyu l. rev. 361, 364 (2015). 138. medicare and medicaid programs; payment policies under the physician fee schedule, 87 fed. reg. 45860 (july 29, 2022). 139. id. at 46098. 140. id. at 46040. 141. id. at 46163. 142. id. at 46094. 143. id. at 46082. 2024] unaccountable care 491 iii. analysis a. have acos achieved their goals? for the accountable care organizations to maintain their rule of reason status, they must prove that their behavior is reasonably necessary to achieve their triple aim goals. 144 the goals of the triple aim are to reduce healthcare costs, provide a better individual experience, and improve population health. 145 the anticompetitive behavior must be reasonably necessary to achieve these goals. so, it is necessary to analyze how acos performed in each of the triple aim categories. in terms of savings, the data is pretty clear. acos save the cms money and since the cms is funded through tax dollars it eventually saves the taxpayer money. 146 in the first five years after the adoption of the aco program, the medicare shared savings program participating acos only had modest annual net savings.147 the reason for the slow start to aco savings was difficulty in adoption and formation of acos. 148 many organizations could not take advantage of the mssp reimbursements because they had difficulties meeting the benchmarks or justifying taking on more patient risk. 149 eventually, in 2019 annual savings nearly doubled to $1.4 billion and signaled that the aco savings that cms had promised had finally been delivered.150 most scholars agree that an overhaul in how the program penalizes providers for not meeting cost and quality benchmarks is the lead driver in the cost savings.151 in 2020 it is estimated that the program saved medicare about $4 billion while in 2021 it saved a more modest $1.6 billion. 152 ————————————————————————————— 144. j. michael mcwilliams & alice j. chen, understanding the latest aco “savings”: curb your enthusiasm and sharpen your pencils—part 1, health aff. forefront (nov. 12, 2020), https://www.healthaffairs.org/content/forefront/understanding-latest-aco-savings-curbyour-enthusiasm-and-sharpen-your-pencils-part-1https://www.healthaffairs.org/do/10.1377/fore front.20201106.719550/. [perma: https://perma.cc/q65v-z58w]. 145. donald m. berwick et al., the triple aim: care, health, and cost, 27 health aff. forefront 759, 760 (may/june 2008), https://doi.org/10.1377/hlthaff.27.3.759 [https://perma. cc/c9f8-nla9]. 146. cms supra note 16. 147. allen dobson et al., estimates of savings by medicare shared savings program acos, naacos, https://www.naacos.com/full-report-for-mssp-savings-2012-2015 [https://perma.cc/ l6kv-vnt9] (last visited nov. 19, 2022). 148. mcwilliams & chen, supra note 139. 149. id. 150. id. 151. jonathan gonzalez-smith et al., the medicare shared savings program in 2019: positive results during major transitions and on the eve of a pandemic, health aff. forefront (oct. 20, 2020), https://www.healthaffairs.org/do/10.1377/forefront.20201016.884 678/ [https://perma.cc/bnp4-wvde]. 152. thomas sullivan, acos saved medicare more than $4 billion in 2020, accountable care organizations (dec. 5, 2021) https://www.policymed.com/2021/12/acos-savedmedicare-more-than-4-billion-in-2020.html [https://perma.cc/xy92-lv3k]. https://perma.cc/xy92-lv3k https://www.policymed.com/2021/12/acos-saved https://perma.cc/bnp4-wvde https://www.healthaffairs.org/do/10.1377/forefront.20201016.884 https://perma.cc https://www.naacos.com/full-report-for-mssp-savings-2012-2015 https://perma https://doi.org/10.1377/hlthaff.27.3.759 https://perma.cc/q65v-z58w https://your-enthusiasm-and-sharpen-your-pencils-part-1https://www.healthaffairs.org/do/10.1377/fore https://www.healthaffairs.org/content/forefront/understanding-latest-aco-savings-curb indiana health law review [vol. 21:475 492 as for individual experience, the quality requirements of the mssp have led to better patient outcomes. at its heart, the aco and the mssp are quality improvement organizations. unless the participating provider meets the quality benchmark, they will not get paid by the mssp. 153 thus, the mssp has been effective at policing provider outcomes. in 2021, the mssp reported that nearly all providers met quality benchmarks to be reimbursed as part of the mssp reimbursement program while having average performance and quality measures higher than those of non-participating physicians’ groups. 154 finally, how did acos do at improving population health? accountable care organizations were first marketed as an alternative to “normal” managed care. 155 when the program first started the number of participating groups in mssp acos was rapidly accelerating. 156 however, in the past five-or-so years the number of clinicians participating in the program has begun to stagnate. 157 this has not translated into a decrease in the number of enrollees covered in the program. 158 currently, about 11 million medicare enrollees are served by about 525,000 aco participant clinicians. 159 this is a significant population who benefits from the care provided by acos. acos certainly have been successful at achieving their goals. 160 the inability of other payer models to do what acos have done demonstrates that the anticompetitive behavior that the ftc and doj permitted for acos was reasonably necessary for their success. the ftc and doj’s plan to put the oversight in the hands of cms was pragmatic. the strict quality and cost requirements from cms proved to be a good measure of anticompetitive behavior. 161 if any aco participant began to practice anticompetitively then they would fall out the program and be penalized for providing low quality care. 162 in reverse, if the participant was acting in a way to drive up costs, then ————————————————————————————— 153. tu, supra note 6. 154. centers for medicare and medicaid services, medicare shared savings program saves medicare more than 1.6 billion in 2021 and continues to deliver high-quality care, newsroom (aug. 30, 2022), https://www.cms.gov/newsroom/press-releases/medicare-sharedsavings-program-saves-medicare-more-16-billion-2021-and-continues-deliver-high [https://perma.cc/kg9q-2gbr]. 155. how do acos and mcos compare and contrast, george washington university (may 13, 2019), https://healthcaremba.gwu.edu/blog/how-do-acos-and-mcos-compare-andcontrast [https://perma.cc/p5qz-rg4j]. 156. statista, number of accountable care organizations (acos) participating in the medicare shared savings program in the united states from 2012/2013 to 2022, statista (last visited nov. 19, 2022), https://www-statista-com.proxy.ulib.uits.iu.edu/statistics/1278895/ number-of-acos-in-medicare-shared-savings-program/ [https://perma.cc/dd34-uaa2]. 157. id. 158. id. (the acos collectively care for around 10.9 million beneficiaries in 2023, which is roughly one in six medicare enrollees.” id. 159. id. 160. id. 161. sullivan, supra note 147. 162. see generally cms, supra note 4. see also, repealed aco guidelines supra note 9, at 4. https://perma.cc/dd34-uaa2 https://www-statista-com.proxy.ulib.uits.iu.edu/statistics/1278895 https://perma.cc/p5qz-rg4j https://healthcaremba.gwu.edu/blog/how-do-acos-and-mcos-compare-and https://perma.cc/kg9q-2gbr https://www.cms.gov/newsroom/press-releases/medicare-shared 2024] unaccountable care 493 their savings would not be paid out. 163 the self-regulating system designed by cms has been successful. does this disprove the worries of aco critics? not at all, instead it shows that there were aspects of acos which the critics and regulators could not yet anticipate. 164 specifically, the aco system leads to anticompetitive mergers and acquisitions between aco participants which directly impacts the triple aim of healthcare. 165 b. anticompetitive merger of aco participants. most criticism of acos was directed to worries about horizontal price fixing, 166 instead aco skepticism should have been focused on “soft consolidation” turning into actual mergers and acquisitions. 167 the likelihood of an aco participant to merge is significantly higher than other providers. 168 ftc guidance explicitly indicates that a merger or acquisition of an aco participant will not be governed by the aco guidelines. 169 by focusing solely on pricefixing issues, the federal guidance failed to anticipate that there would be concerns regarding aco consolidation. in a 2020 study, counties with above average aco participation were shown to have 5% higher rates of mergers and acquisitions than counties that did not have high levels of aco participation. 170 this is attributed to the aco members working closely together with one another and learning of the benefits that could be gained by integrating clinical systems. 171 because of the agencies voluntary bliss. so, providers working together to provide low cost care in the aco scheme are not likely to stay in that system. 172 which is especially unfortunate considering that medicare enrollees and taxpayers are forced to pick up the costs associated with healthcare consolidation. 173 the medicare enrollee will pay more because their copays and other fees will increase according to any increase in cost on the provider’s side.174 while the taxpayer will be forced to pay more since medicare and medicaid are funded through taxes. 175 with the ————————————————————————————— 163. id. 164. kanter, supra note 1. 165. id. (the anticipation that aco participants would merge at higher rates than other healthcare provider systems.) id. 166. see generally collin c. groebe, note, the evolution of federal courts’ healthcare antitrust analysis: does the ppaca spell the end to hospital mergers?, 92 wash. u. l. rev. 1617, 1628 (2015). 167. kanter et al. supra note 1. 168. id. 169. repealed aco guidelines, supra note 9, at 3. 170. kanter et al., supra note 1. 171. id. 172. id. 173. cms, supra note 16. 174. id. 175. id. indiana health law review [vol. 21:475 494 federal and state governments already shelling out for healthcare at increasingly shocking amounts, any increase in costs deserves serious consideration. it is unpersuasive to argue that mergers and acquisitions by aco participants is reasonably necessary for the accomplishment of the triple aim. while merger or acquisitions can be procompetitive, that is not always the case. 176 if a merger is in restraint of trade and does not offer any “merger specific benefits,” then the merger is anticompetitive and must be struck by the courts. 177 there are no pro-competitive benefits available to an aco participant which wishes to merge with another. 178 every pro-competitive benefit possible through merger was already addressed by the aco system specifically, proponents of merger and acquisition argue that the efficiency gains by information sharing and price sharing allow for reduced costs and improved continuity of care. 179 and to a certain extent, those advocating for consolidation in healthcare are correct. it is much more efficient to run a healthcare organization if it benefits from horizontal and vertical integration. 180 streamlined continuity of care is much cheaper and more effective than disparate providers not coordinating with one another. 181 however, all of those benefits are available to acos. 182 they can share information with one another about patients, they coordinate care, and they get rewarded when the program keeps costs down and quality up. 183 acos can even share pricing information together and negotiate with payors as a collective. 184 it seems, the only benefit of a merger of aco partners is to remove the profit incentive from keeping high quality outcomes. 185 the only potential benefit of merger and acquisition is in the form of profit to the ownership group which no longer needs to be concerned with meeting the aco benchmarks to receive their bonus. 186 once merger takes place, profit no ————————————————————————————— 176. dirk hackbarth, can horizontal mergers boost competition? promarket (aug. 14, 2018), https://www.promarket.org/2018/08/14/can-horizontal-mergers-actually-boost-competi tion [https://perma.cc/9vbg-hl5m]; c.f. tyler j. kubik, the efficiencies defense after anthem: asymmetric burdens and strict scrutiny of merger efficiencies, 26 geo. mason l. rev. 1365, 1365 (2019). (highlighting the strict scrutiny of merger specific benefits when analyzing mergers and acquisitions.) 177. id. 178. tu, supra note 6. 179. monica noether & sean may, hospital merger benefits views from hospital leaders and econometric analysis, am. hosp. ass’n, (jan. 2017) https://www.aha.org/guidesreports/ 2017-01-24-hospital-merger-benefits-views-hospital-leaders-and-econometric-analysis [https:// perma.cc/5jem-bgw2]. 180. id. at 3. 181. id. 182. tu, supra note 6, at 8. 183. id. 184. id. 185. id. 186. fred schulte, sick profit: investigating private equity’s stealthy takeover of health care across cities and specialties, kff health news, (nov. 14, 2022), https://khn.org/news/ https://khn.org/news https://www.aha.org/guidesreports https://perma.cc/9vbg-hl5m https://www.promarket.org/2018/08/14/can-horizontal-mergers-actually-boost-competi 2024] unaccountable care 495 longer flows from the accomplishment of the triple aim, instead it flows from the reduction in cost of services and an increase in the number of services provided. 187 without any quality requirement, the newly merged aco participants are encouraged to do the highest number of procedures for the highest price. in a consolidated system without the aco quality protection a patient’s care may decrease in quality and thus their outcomes suffer. 188 it has already been shown that an aco leads to better outcomes for its patients than in a non-aco provider, so it is expected that the quality and outcomes will be worse in a consolidated aco. 189 although removing the government’s ability to oversee a business has not yet been recognized as a procompetitive benefit, it is a necessary aspect of the aco system. without the oversight, the ftc and doj would not have given their blessing to acos. 190 c. necessary changes to federal regulation the now repealed doj and ftc guidance is focused on ensuring that aco participants who take part in the mssp are protected from antitrust enforcement. based on the context and the time when the guidance was written, the agencies would not have been concerned with what aco participants would eventually do when they decided to stop participating. instead, the guidance focuses on encouraging aco participation, and instilling confidence that the aco system would not be anticompetitive. 191 now, the agencies have the opportunity to implement regulations to prevent these mergers. if not, cms will continue to be required to pay higher costs for medicare enrollees and the enrollees themselves will pay higher out of pocket costs for lower quality care. further, the horizontal merger guidelines and “general principles of antitrust enforcement” will be inappropriately applied to acos, resulting in them losing critical protections from antitrust enforcement. specifically, the new guidelines need to include a provision which will require that any merger between aco participants will not be analyzed under the rule-of-reason. instead, the standard needs to be changed to a quick-look analysis. to someone with “even a rudimentary understanding of economics,” the merger of a former aco participant with another similarly situated clinician ————————————————————————————— article/private-equity-takeover-health-care-cities-specialties/ [permalink: https://perma.cc/syy72l99]. 187. id. 188. see generally id. if the motive in private equity funded hospitals is only profit, then it is fair to impute that motive onto consolidated acos which no longer have their profit motive based on quality of care. id. 189. id. 190. id. 191. id. https://perma.cc/syy7 indiana health law review [vol. 21:475 496 is clearly anticompetitive.192 it is a naked restraint on the healthcare market. it is abandoning a model which keeps costs down and quality up and moving to a system which has documented pattern of increasing costs and decreasing quality. 193 so, the agencies could prevail in court with a simple quick look analysis of the proposed merger. unfortunately, the guidance on this issue is also lacking in that it is not as easily applied to small clinicians, who are more likely to be aco participants. 194 thus, the aco participants who need this regulation the most are also the most likely to be overlooked. by incorporating the language into new aco specific guidelines, the agencies would be drawing a hard line in the sand. pointing to aco participants and declaring that mergers will be viewed under a quick-look model, is a much stronger carrot than saying “we will let the horizontal guidelines dictate this issue.” additionally, the guidelines for acos are only for acos. this negates any concern about quick look being applied too broadly to other industries. on the other hand, the logistical concerns of monitoring aco mergers and acquisitions are real. specifically, the higher burden on the regulating agencies. overextension of the ftc and doj antitrust enforcement is a real concern. it would be unwise to require them to analyze every merger and acquisition in every healthcare market. however, they are not going to be alone in implementing these new requirements. by effectively partnering with state attorneys general, the federal government can shift some of its burden over to the states. this is not an unprecedented idea and would not require any overhaul of agency procedure. the ftc, doj, and the states already work closely with one another to ensure that federal and state consumer law is enforced across the nation. the states serve a boots-on-the-ground purpose to the federal agencies. recent successes by state attorneys general have grown support for state action to protect their residents. for instance, the opioid litigation has greatly increased the public’s confidence that ags will act in the best interest of their citizens. 195 with this power, the ags would have public support on their side to defeat these anticompetitive mergers before they get into court. in people v. sutter health, a case from california eventually settled out of court, the attorney general of california was able to negotiate a settlement for the anticompetitive behavior of one of the largest hospital networks in the ————————————————————————————— 192. cal. dental ass’n., 526 u.s. at 770. (recall, this standard is required by cal. dental ass’n v. ftc, or else an in-depth market analysis is required); see also supra text accompanying note 32. 193. jacqueline lapointe, healthcare private equity down but not out, rev cycle intelligence, (jan. 19, 2023), https://revcycleintelligence.com/news/healthcare-private-equitydown-but-not-out-report-finds (https://perma.cc/ljn3-vqbf). 194. kanter, supra note 1. 195. people v. sutter health, 2018 cal. super. lexis 1948. (this action was brought by former california attorney general xavier becerra, who is at the time of writing the secretary of health and human services.) https://perma.cc/ljn3-vqbf https://revcycleintelligence.com/news/healthcare-private-equity 2024] unaccountable care 497 state. 196 the lawsuit was based entirely on state law causes of action. 197 this action could be replicated throughout the country. the participation between strong state ags and the federal regulators is crucial for the success of regulating acos. some states have requirements in place to review healthcare mergers and acquisitions pre-consummation. 198 even in these states, enforcement of purely state law antitrust rules is not common. sutter demonstrates that this does not need to be the case and state law can prevail as the only ground on which to block a healthcare merger. 199 also, state attorneys general have shown that they can work together independent of the federal government to enforce antitrust policy. 200 for instance, attorneys general across the country have come together to enforce their state and federal laws regarding antitrust. 201 this shows that there is nothing stopping attorneys general offices from blocking these mergers. especially considering the hyper-local market analysis which might be necessary to enforce antitrust laws on aco participants, the attorneys general might be better positioned than the federal government to act against aco consolidation. what does limit the attorneys general from achieving their goals is the cost associated with enforcement. 202 many attorneys general offices are limited in their resources and convincing them to act can be difficult. 203 also, many rely heavily on complaints from constituents. in many cases, complex cases like this cannot get off the ground because the patient’s themselves do not know that they are the victim of anticompetitive practices. 204 they will feel the increased costs in their pocketbook but have no knowledge of the complex organizational ————————————————————————————— 196. id. 197. id. 198. alexandra montauge et. al, state action to oversee consolidation of health care providers, milbank memorial fund (aug. 5, 2021), https://www.milbank.org/publications/ state-action-to-oversee-consolidation-of-health-care-providers/ [https://perma.cc/6t3r-rj5w]. 199. california and washington have seen great success in their courts bringing solely state antitrust claims. see generally cal. office of atty gen., antitrust enforcement in california: how you can help. https://www.oag.ca.gov/sites/all/files/agweb/pdfs/antitrust/antitrust.pdf (last visited feb. 29, 2024) [https://perma.cc/h57x-p9ue]. 200. diego lasarte, the ongoing big tech antitrust cases to watch in 2023, quartz (jan. 24, 2023), https://qz.com/antitrust-cases-big-tech-2023-guide-1849995493 [https://perma.cc/ 3qmk-54qz]. 201. id. 202. see generally clark corbin, after budget concerns, jfac reduces raises for idaho attorney general’s office, idaho capital sun (mar. 20, 2023, 4:38 pm), https:// idahocapitalsun.com/2023/03/20/after-budget-concerns-jfac-reduces-raises-for-idaho-attorneygenerals-office/ [https://perma.cc/5w5z-y7ly] (supporting the position that state ag offices are underfunded.). 203. see generally id. 204. the challenge of health care fraud, nhcaa, https://www.nhcaa.org/toolsinsights/about-health-care-fraud/the-challenge-of-health-care-fraud/ [https://perma.cc/u4v8-m5 rz] (last visited july 27, 2023). https://perma.cc/u4v8-m5 https://www.nhcaa.org/tools https://perma.cc/5w5z-y7ly https://idahocapitalsun.com/2023/03/20/after-budget-concerns-jfac-reduces-raises-for-idaho-attorney https://perma.cc https://qz.com/antitrust-cases-big-tech-2023-guide-1849995493 https://perma.cc/h57x-p9ue https://www.oag.ca.gov/sites/all/files/agweb/pdfs/antitrust/antitrust.pdf https://perma.cc/6t3r-rj5w https://www.milbank.org/publications indiana health law review [vol. 21:475 498 structures which lead to these changes. therefore, any attempt by state attorneys general must be coupled with an increase in education to the public about their rights and some way to help fund these investigations by state attorneys general. a patient also has a private right of action under both state and federal antitrust law. 205 this might be an additional tool to keep pressure off of the overworked regulators. if private plaintiffs’ attorneys are willing to put in the work to complete market analysis and take a consolidated aco into court, they can win sizable awards for their clients while benefiting the public. 206 also, since it is a private action, the plaintiff will be unbound from the federal guidance on antitrust law. 207 this would allow them to argue for the use of quick look analysis instead of rule of reason. unfortunately, the private attorney will run into the same cost and time roadblocks the federal regulators will if they have to overcome a rule of reason defense. so, it is crucial that the regulators set an example by waiving their own standard of review. d. criticism of the aco reach program the issue with this proposed aco expansion is that it will permit private firms to get involved in the aco model. 208 set up as a middleman in between the providers and medicare, a new player representing private interests has been introduced to the mssp aco scheme: the direct contractor. the direct contractor is an independent entity who receives the payment from medicare to the aco participant and ensures that the quality standards are met before payment is dispersed. policymakers and regulators are concerned with the attention the aco direct contractor has received from private equity and other capital focused firms. 209 while there is nothing necessarily anticompetitive about these firms getting involved in the aco scheme, they carry a connotation which worries lawmakers. 210 since their motive is purely to achieve profit, many regulators are concerned that the direct contractors will have perverse incentives and encourage anticompetitive behavior.211 afterall, what makes the acos so beneficial is that they put the cost and financial risk of care in the hands of clinical providers, not ————————————————————————————— 205. 15 u.s.c. § 15(a) 206. id. 207. id. (private right of action is based entirely on §15(a) of the clayton act, not on federal regulatory framework). 208. robert king, house progressives push for cms to end newly rebranded aco reach model, fierce healthcare, (mar. 17, 2022), https://www.fiercehealthcare.com/payers/houseprogressive-push-cms-end-newly-rebranded-aco-reach-model [https://perma.cc/9fty-grah] (the aco reach model was proposed and lobbied for by aco industry groups like the national association for acos.). 209. id. 210. id. 211. id. https://perma.cc/9fty-grah https://www.fiercehealthcare.com/payers/house 2024] unaccountable care 499 third parties reviewing their decisions. a private third party getting involved in the aco process is not as clearly anticompetitive as a merger between two former aco participants. the agencies will probably have to go a bit further than a quick look analysis in this case to prove that it would violate the statute. but nevertheless, if the effects of this new aco reach system are what politicians think they will be, then the regulators must remove reach participants from the zone of safety. even if rule-of-reason analysis is necessary, this should not be barring the agencies from bringing action against aco reach participants who act anticompetitively. if not, then the triple aim will no longer be the purpose of the accountable care organizations. instead, the profitability and financial success of the aco will become the organization’s priority. as the rest of the healthcare industry has seen, the introduction of private equity firms into the management and provision of healthcare has had terrible effects on cost, quality, and access. 212 so, it seems unwise to encourage these firms to join acos. especially when the purpose of the reach program is to increase the equitable distribution of highquality care. not every government intervention needs a private-public partnership to justify its existence. sometimes, a program can exist solely on its own merit, and acos have shown that they can be successful on their own. e. preventing aco participants from merging. preventing this consolidation should be the primary focus of any new regulation. thus, any regulatory changes must be able to prevent anticompetitive effects before the consolidation takes place. conspiracy to place a restraint on trade is a violation of the sherman antitrust act. 213 conspiracy to restrain trade requires two or more people planning to restrain trade by producing anticompetitive effects which outweigh any procompetitive effects stemming from the agreement which affects interstate or foreign commerce. 214 federal and state regulators, after revision of the federal aco guidance to include quick-look analysis, can use conspiracy to restrain trade to prevent potential consolidation of aco participants. 215 a couple hurdles make this more difficult than a “normal antitrust” action. first, a conspiracy action requires proof that the restraint would outweigh any procompetitive effects. 216 second, there must be some form of overt action that would clearly demonstrate anticompetitive action. 217 the requirement for an overt action poses an interesting problem in aco antitrust. the organization members already are participating in overt anticompetitive action. specifically, they share ————————————————————————————— 212. schulte, supra note 187. 213. 15 u.s.c. § 1 (1890). 214. id. 215. areeda & herbert hovenkamp, supra note 17, at § 101. 216. id. 217. id. at § 1416 indiana health law review [vol. 21:475 500 information and act in a concerted effort to set prices, contain spending, and coordinate care. 218 this type of behavior would be described as “tacit coordination,” or merely the coordination of competitors which is created by interdependence. 219 an overt action would be something like secretive meetings or communication, a contract to agree to merge, or something else that a regulator could point to and easily identify as anticompetitive. 220 further, the conspiracy litigation, if successful, would solidify that the acos require the federal regulation in order to remain valid under the antitrust statutes. this would put the third parties who profit from acos on notice that they cannot simply strip the profit out of the acos and walk away. f. unwinding consummated mergers simply put, the damage has already begun with aco mergers. 221 the data is clear that aco participants have already begun to consolidate at a high rate. 222 so, how can the state and federal regulators undo the mergers and acquisitions of aco participants? this can be done through the use of post-consummation lawsuits brought by federal and state governments. a post-consummation action mirrors the pre-consummation actions in that it requires that the plaintiff prove that the defendant acted in restraint of trade. 223 however, a post-consummation merger requires proof that it had actual negative effects on the market. 224 this means if a merger has already taken place, then the plaintiff must show that there were actually negative trade results. 225 this is a difficult hurdle to meet and requires a standard of review higher than quick look or rule of reason. it requires essentially per se analysis of the proposed restraint on trade. 226 considering that there is sufficient evidence to show that there have been negative effects on price and quality by aco participants merging, this standard should be achievable. iv. conclusion accountable care organizations work. they are effective tools to contain costs and improve quality. the data shows that the aco system can lead to lower costs, higher quality, and greater access. acos have saved billions of dollars over the past decade. they contain anticompetitive qualities, but the procompetitive benefits have outweighed those aspects. the aco gives the ————————————————————————————— 218. id. 219. id. 220. id. 221. kanter et. al, supra note 1, at 1936. 222. id. at 1941. 223. areeda & herbert hovenkamp, supra note 17, at § 315(b). 224. id. and that the negative effects would not have occurred otherwise. id. 225. id. 226. id. 2024] unaccountable care 501 benefits of a merger or consolidation without the risks of price hikes and reduced quality. from a financial point of view, it seems that preserving the aco model is crucial to keeping medicare and medicaid functional. to keep acos, the government must overcome the fundamental truth that adam smith wrote in wealth of nations, and that justice posner paraphrased in his rockford opinion: “most people do not like to compete and will seek ways of avoiding competition by agreement tacit or explicit, depending of course on the costs of agreeing.” so, how can the federal government maintain the aco system but avoid their members from merging? by publishing new guidelines to include a quick look analysis of any proposed merger of healthcare entities who were previously members of the same aco. if the federal and state governments can come together to draft new guidance then the harm that has already been done can be reversed and further harm can be stopped. by promulgating new guidance to include quick-look review of aco participant mergers, the agency can prevent these mergers from taking place. instead of asking whether the anticompetitive behavior is reasonably required to achieve the pro-competitive gains, the authors of the new guidance should ask whether the effects of an anticompetitive merger are so clear that even someone with a “rudimentary understanding of economics” could see the harm. since this requires a clear proof of anticompetitive harm, this standard might be a bit more difficult to achieve. however, when the harm is clear the standard is easier to achieve than rule of reason. in the case of aco participants merging, the harm is clear. under this new standard of review the agencies will be able to bring conspiracy to restrain trade suits against potentially consolidating acos and bring post-consummation suits against those that already have merged. further, it will allow the federal government, state agencies like their attorney general, and private citizens to bring more meritorious claims against these consolidating acos. this has to happen now before any further changes to the aco model can be implemented. the effects of private organizations entering the aco scheme has politicians concerned. if plans like the reach model are implemented before any change to the antitrust framework for acos can be implemented, then we will see consolidation trends increase drastically. the aco reach has wonderful goals which should be applauded, increasing the access and equity of acos is something that everyone agrees is necessary. however, the method to do so will only further drive acos away from their original goal of keeping cost, quality, and access down. by including private third-party payors into the program, reach will result in skyrocketing costs and undermine the integrity of the entire aco program. indiana health law review [vol. 21:475 502 the future for acos does not look bright unless the regulators can come together to draft new pro-competitive guidance. while it appears that the regulators are doing this now, it may not be soon enough. hopefully any new guidance will reflect the reality that aco participants do not want to compete and will do whatever they can to avoid being forced to compete. structure bookmarks naccountable arehe angers of ederal upport for nticompetitive ehavior in the ealthcare arket indiana health law review volume xx 2023 number 1 articles gutting grutter: the effect of the loss of affirmative action on diversity among physicians asees bhasin & gregory curfman, m.d.* abstract over the last four decades, race-conscious admission policies have been the subject of heated judicial and social controversy. in 1978, in the case regents of the university of california v. bakke, the consideration of race was held to be permissible to serve the compelling interest of promoting diversity in higher education. since then, this issue has come up before the supreme court several times. in october 2022, the supreme court of the united states heard oral arguments in two cases—students for fair admissions v. president & fellows of harvard college and students for fair admissions v. university of north carolina. in the harvard case, students for fair admissions (“sffa”), a conservative organization led by edward blum, argues that harvard discriminates against asian american applicants, thereby violating title vi of the civil rights act of 1964. in both the harvard college and university of north carolina cases, sffa argues that the supreme court should overrule grutter v. bollinger, a case that cemented the proposition that narrowly tailored admission policies that consider race to achieve diversity are constitutional. on a second level, sffa argues that both harvard’s and unc’s policies are not narrowly tailored due to their rejection of workable race-neutral alternatives. part i of this article provides an overview of past litigation concerning affirmative action policies. part ii discusses the two cases students for fair admissions v. president & fellows of harvard college and students for fair admissions v. university of north carolina that are up for consideration before the supreme court. part iii discusses the importance of diversity in the medical workforce, and the potential impact of the sffa lawsuits on medical practice. part iv discusses arguments that may become important in these cases, potential outcomes of this litigation, and what the future of higher education looks like if * asees bhasin, law & policy fellow for the evidence equity project at the center for antiracist research, formerly the senior research fellow at the solomon center for health law and policy yale law school. gregory curfman, deputy editor of jama, senior advisor, and physician scholar in residence for the solomon center for health law and policy at yale law school. 2 indiana health law review [vol. 20:1 race is prohibited from being considered in university admissions. table of contents introduction i. a brief history of the litigation surrounding affirmative action ii. the students for fair admissions litigation a. should grutter v. bollinger be overruled? b. did the admission policies meet the strict scrutiny standard? iii. the importance of diversity in the medical profession iv. potential outcomes of the sffa litigation and the path forward conclusion introduction in 1978, a polarizing question appeared before the supreme court in regents of the university of california v. bakke—are universities permitted to consider race as a factor in admissions? justice powell’s controlling opinion found that it could be constitutionally permissible if serving the compelling interest of promoting diversity in higher education. since this decision, over the last four decades, race-conscious admissions policies have been the subject of social, political, and judicial controversy, and have raised questions about the scope of the fourteenth amendment. the admissions policies have also been criticized as sanctions of “reverse-discrimination,” a claim recently made by asian-american students in relation to the students for fair admissions v. president & fellows of harvard college. on january 24, 2022, the supreme court agreed to hear challenges to affirmative action policies in college admissions at harvard university and at the university of north carolina (“unc”). the cases are students for fair admissions v. president & fellows of harvard college and students for fair admissions v. university of north carolina were argued on october 31, 2022. students for fair admissions (“sffa”) is an organization led by edward blum, a conservative activist who also initiated the litigation in shelby county v. holder and fisher v. university of texas ii.1 while the court has repeatedly upheld admissions programs similar to the ones being challenged in this lawsuit (as recently as 2016), these cases may come out differently due to the conservative supermajority of justices that will be hearing these cases. this article will discuss the potential impact of these cases on affirmative action policies of universities and will examine how this may affect the practice of medicine. part i will provide a brief overview of affirmative action jurisprudence to situate this case within a long history of affirmative action litigation. part ii will discuss the two cases being litigated by sffa. part iii will expand upon the importance of diversity in the medical workforce and describe 1. anemona hartocollis, he took on the voting rights act and won. now he’s taking on harvard, n.y. times (nov. 19, 2017), https://www.nytimes.com/2017/11/19/us/affirmative-actionlawsuits.html [https://perma.cc/k66z-qe47]. 2023] gutting grutter 3 how affirmative action policies promote diversity among physicians. part iv will discuss the possible outcomes of this litigation and what the path forward looks like if the court decides to prohibit race as a consideration in higher education. i. a brief history of the litigation surrounding affirmative action the affirmative action debate has continued across the united states for decades, and the supreme court has ruled on several cases that have shaped current practices on race-based admissions. the first case was regents of university of california v. bakke, decided in 1978, concerned a white man who alleged that he had been denied admission to the university of california school of medicine at davis due to the school’s consideration of race in the admissions process.2 the court found that the use of race in school admissions would trigger the strict scrutiny standard of review, which warranted a showing that the government had a compelling interest and that the means chosen were narrowly tailored to achieve that interest.3 in bakke, the medical school’s special admissions program was organized so that underrepresented minority applicants were considered in a separate pool from other applicants,4 and the two different pools had different admissions criteria. also, the school had a specific racial quota (16 of 100 students in each class were allotted to underrepresented minority applicants).5 justice powell’s opinion upheld the use of race as a consideration in higher education admissions generally but found that specified quotas were unconstitutional. in 2003, the supreme court reaffirmed the holding in bakke in grutter v. bollinger. in which the court upheld the university of michigan law school’s admission policy that focused on students’ academic abilities, flexibly assessed their experiences and application materials, and looked at “soft variables” to ensure a critical mass of students from underrepresented minority groups.6 on the same day, the supreme court also decided gratz v. bollinger, in which it found that the university of michigan’s undergraduate admission policy— that use a system that awarded points to applicants from racial and ethnic minorities— was unconstitutional due to its lack of individualized assessment.7 in fisher v. university of texas at austin, which came up twice before the supreme court, in 2013 (“fisher i”) and 2016 (“fisher ii”), a white woman challenged the university of texas’ admission policies, which dictated that 75% of the freshman class be allocated to students from the “texas’ top ten percent program while the remaining 25% would be admitted taking into account students’ “personal achievement index” that considered their race among other 2. regents of university of california v. bakke, 438 u.s. 265, 276 (1978). 3. id. at 290-91. 4. id. at 274. (identifying “minority groups” as “blacks, chicanos, asians, and american indians” (internal quotations omitted)). 5. id. at 274-76. 6. grutter v. bollinger, 539 u.s. 306, 309 (2003). 7. gratz v. bollinger, 539 u.s. 244, 246 (2003). 4 indiana health law review [vol. 20:1 factors.”8 here, abigail fisher—the plaintiff—was not among the top ten percent of her high school class and alleged that she was rejected because of her race.9 in fisher ii, the supreme court applied strict scrutiny and found that courts also must consider, in their analysis of narrow tailoring, whether universities have other race-neutral alternatives available.10 on these facts, the supreme court found that the university here had adequately demonstrated that race-neutral alternatives would not achieve their compelling interest in diversity.11 ii. the students for fair admissions litigation the two cases at hand, students for fair admissions v. president & fellows of harvard college and students for fair admissions v. university of north carolina, were considered by the supreme court at three consecutive conferences in 2022 before review was granted.12 the admission policies followed by harvard and unc have similarities and differences. in harvard’s first-read of the thousands of undergraduate applications it receives, it assesses applicants in four areas— academic, extracurricular, athletic, and personal.13 while harvard held that race does not inform a student’s personal score, experiences tied to an applicant’s race did.14 in its application process, harvard also uses a system of “tips,” or plus factors that are considered during the ratings and committee review processes.15 these tips include the consideration of race, and tips are also given to athletes, legacy applicants, dean’s interest list applicants, and children of faculty or staff (aldcs).16 the university of north carolina’s policy differs slightly from that of harvard’s. unc uses a list of forty criteria, one of which is race, which may be considered at any stage of the admissions process.17 readers assign a numerical rating for some of these categories, but the scores are never added together, and while race, in addition to other criteria, may be awarded a “plus,” it is not assigned a numerical value, nor does it result in admission.18 8. fisher v. university of texas, 570 u.s. 297, 305-07 (2013). 9. id. 10. fisher v. university of texas, 579 u.s. 365, 365 (2016). 11. id. 12. amy howe, court will hear challenges to affirmative action at harvard and university of north carolina, scotus blog (jan 24, 2022, 11:44 am), https://www.scotusblog.com/2022/ 01/court-will-hear-challenges-to-affirmative-action-at-harvard-and-university-of-north-carolina/ [https://perma.cc/jm3g-jgva]. 13. brief for respondent at 7, students for fair admissions v. president & fellows of harvard college, 142 s. ct. 895 (2022). 14. id. at 8. 15. id. at 30. 16. id. 17. brief for respondent at 9, students for fair admissions v. university of north carolina (2022) (no. 21-707). 18. id. at 9-11. 2023] gutting grutter 5 in both cases, sffa asks whether the court should overrule grutter v. bollinger and hold that institutions of higher education cannot use race as a factor in admissions.19 sffa also asks whether there is a violation of the u.s. constitution due to improper compliance with the equal protection clause, and title vi of the civil rights act of 1964.20 a. should grutter v. bollinger be overruled? to fully understand what grutter accomplished, a deeper analysis of the bakke case is warranted. in bakke, davis’ special admissions program that considered race purported to serve four purposes: “(i) reducing the historic deficit of traditionally disfavored minorities in medical schools and in the medical profession (ii) countering the effects of societal discrimination; (iii) increasing the number of physicians who will practice in communities currently underserved; and (iv) obtaining the educational benefits that flow from an ethnically diverse student body.”21 as law professor guido calabresi identified, bakke involved a clash between two conceptions of egalitarianism—one that implicated the meritocratic notion of opportunity regardless of race, and the other that was built on the idea of reparation because of society’s past discrimination.22 this contradiction was reflected by the court. on one hand, four justices voted to invalidate the davis affirmative action program under title vi of the 1964 civil rights act (and did not reach the constitution).23 on the other hand, four justices voted to uphold the affirmative action program, including for remedial reasons, and declared the davis admissions program to be constitutional on the basis of the equal protection clause of the fourteenth amendment.24 justice powell, who provided the swing vote, split the difference between these two factions, finding that davis’ program was impermissible under both title vi and the equal protection clause, while refusing to invalidate affirmative action programs generally. justice stevens’ authored the opinion, joined by chief justice burger and justices stewart and rehnquist, which held that the dispute at hand did not require the consideration of constitutional questions. instead, the dispute can be settled by considering title vi, which he held was independent from the equal protection clause and consisted of “language and emphasis in addition to that found in the constitution.”25 upon reviewing the legislative history of the civil rights act of 1964, justice stevens found that there was a distinct statutory 19. see brief for petitioner, students for fair admissions v. president & fellows of harvard college (2022) (no. 20-1199); see also brief for petitioner, students for fair admissions v. university of north carolina (2022) (no. 21-707). 20. id. at 71. 21. bakke, 438 u.s. at 306. 22. guido calabresi, bakke as pseudo-tragedy, 28 cath. univ. l. rev. 427, 427-28 (1979). 23. see bakke, 438 u.s. at 412-21 (stevens, j., concurring in part). 24. id. at 375-76 (brennan, j., concurring in part). 25. id. at 416 (stevens, j., concurring in part). 6 indiana health law review [vol. 20:1 prohibition on the exclusion of individuals from federally funded programs because of their race.26 justice brennan’s opinion, joined by justices white, marshall and blackmun, expressed a disagreement with justice stevens’ reading of title vi and found that it was coextensive with the equal protection clause and would permit the use of race in accord with the fourteenth amendment.27 justice steven’s opinion then considered how title vi and the equal protection clause allowed for the remedial use of race-conscious measures: “[a] reading of title vi as prohibiting all action predicated upon race which adversely affects any individual would require recipients guilty of discrimination to await the imposition of such remedies by the executive branch. indeed, such an interpretation of title vi would prevent recipients of federal funds from taking race into account even when necessary to bring their programs into compliance with federal constitutional requirements. this would be a remarkable reading of a statute designed to eliminate constitutional violations, especially in light of judicial decisions holding that under certain circumstances the remedial use of racial criteria is not only permissible but is constitutionally required to eradicate constitutional violations.”28 this reading was substantiated by the justices’ reading of regulations adopted by the department of health, education, and welfare.29 justice brennan next turned to whether a strict scrutiny standard of review should be adopted to review racial classifications serving remedial purposes, and instead followed an intermediate scrutiny standard used for sex discrimination challenges thereby upholding the davis program as constitutional.30 justice powell agreed with the brennan group that title vi had no independent force and only prohibited racial classifications that would violate the equal protection clause.31 justice powell, however, believed that the strict scrutiny standard of review should be applied.32 in his controlling opinion, justice powell found that the first three interests articulated by uc davis would not pass strict scrutiny for different reasons. he opposed the idea that race-conscious admissions were constitutional to meet the interest of “countering societal discrimination.” he found that such programs did not— “. . . justify a classification that imposes disadvantages upon persons like respondent, who bear no responsibility for whatever harm the beneficiaries of the special admissions program are thought to have 26. id. at 418. 27. id. at 325 (brennan, j., concurring in part). 28. id. at 336-37. 29. id. at 343. 30. id. at 357-62. 31. id. at 287. 32. id. at 291. 2023] gutting grutter 7 suffered. to hold otherwise would be to convert a remedy heretofore reserved for violations of legal rights into a privilege that all institutions throughout the nation could grant at their pleasure to whatever groups are perceived as victims of societal discrimination.”33 justice powell, however, found that achieving diversity within the student body was “a constitutionally permissible goal for an institution of higher education.”34 his reasoning centered on “academic freedom” that “though not a specifically enumerated constitutional right, long has been viewed as a special concern of the first amendment.”35 in driving home, the academic importance of diversity, justice powell held that—”[p]hysicians serve a heterogeneous population. an otherwise qualified medical student with a particular background—whether it be ethnic, geographic, culturally advantaged or disadvantaged—may bring to a professional school of medicine experiences, outlooks, and ideas that enrich the training of its student body and better equip its graduates to render with understanding their vital service to humanity.”36 despite the presence of a compelling interest, justice powell concluded that the davis program was not narrowly tailored because it failed the “less burdensome means” requirement by denying bakke his right to individualized consideration.37 in his opinion, justice powell lauded harvard college’s admission program that, without using set target quotas, prioritized creating diversity in the student body following the principle that “[a] farm boy from idaho [could] bring something to harvard college that a bostonian [couldn’t] offer.” the decision in bakke was so severely fractured that it left lower courts wondering how to apply justice powell’s ruling.38 when grutter v. bollinger came before the supreme court in 2003, the diversity rationale adopted by justice powell in bakke was espoused in a 5-4 majority that left no uncertainty.39 here, it became clear that a non-remedial justification for reverse discrimination by a public institution was possible.40 in its reasoning, “the court adopted an expansive vision of racial diversity through a ‘common good’ approach in characterizing the social goods provided by racial diversity.”41 justice o’connor’s opinion considered a variety of interests met by 33. id. at 310. 34. id. at 311. 35. id. at 312. 36. id. at 314. 37. see id. at 318-20. 38. see hopwood v. texas, 78 f.3d 932, 944 (5th cir. 1996) (“justice powell’s argument in bakke garnered only his own vote and has never represented the view of a majority of the court in bakke or any other case”). 39. grutter, 539 u.s. at 325 (“today we endorse justice powell’s view that student body diversity is a compelling state interest that can justify the use of race in university admissions”). 40. id. at 338-40. 41. michelle adams, stifling the potential of grutter v. bollinger: parents involved in 8 indiana health law review [vol. 20:1 racial diversity including benefits related to cross-racial understanding, enhanced learning outcomes and preparation for a diverse workforce and society, enhanced business-related skills developed through exposure to diverse cultures, and cultivating leadership with legitimacy in the eyes of citizenry.42 a crucial aspect of justice o’connor’s opinion in grutter was its emphasis on reviewing a university’s admission decisions with deference— “our scrutiny of the interest asserted by the law school is no less strict for considering complex educational judgments in an area that lies primarily within the expertise of the university. our holding today is in keeping with our tradition of giving a degree of deference to a university’s academic decisions, within constitutionally prescribed limits.”43 in her opinion, however, justice o’connor cautioned that the narrow tailoring component of the strict scrutiny analysis “require[d] that a race-conscious admissions program not unduly harm members of any racial group.”44 justice o’connor provided the swing vote in grutter, and when she retired, the main swing vote on the court was by justice anthony kennedy, who in fisher ii, switched sides (from his dissenting vote in grutter), and voted to uphold the consideration of race.45 in this opinion, justice kennedy provided “controlling principles” that guided his review, and found that a university had to articulate “precise and concrete goals” that were “sufficiently-measurable” to survive strict scrutiny; in addition to providing a reasoned and principled decision for pursuing those goals.46 the first question raised in the family and social services administration (“fssa”) litigation is whether the court should overrule grutter v. bollinger and largely do away with the diversity rationale. before delving into the arguments made by the parties, it is worth considering the criticisms that the diversity rationale has garnered from both the left and right sides of the ideological spectrum. many scholars and commentators framed justice powell’s decision as “judicial statesmanship” since it “neither legitimized racial quotas nor put down affirmative action programs.”47 the same sentiment was echoed by then-professor robert bork who found that justice powell’s opinion interpreted the equal community schools v. seattle school district no. 1, 88 bos. univ. l. rev. 937, 948 (2008). 42. grutter, 539 u.s. at 330. 43. id. at 328. 44. id. at 341. 45. see noah feldman, this supreme court won’t uphold college affirmative action, bloomberg (jan. 24, 2022), https://www.bloomberg.com/opinion/articles/2022-01-24/affirmativeaction-in-college-admissions-faces-supreme-court-curbs [https://perma.cc/xy92-mnrr]. 46. see fisher ii, 579 u.s. at 365. 47. linda greenhouse, bell hails decision, n.y. times (june 29, 1978), https://www. nytimes.com/1978/06/29/archives/bell-hails-decision-calls-ruling-a-great-gain-plaintiff-ispleased.html [https://perma.cc/3hhy-k6mz]. 2023] gutting grutter 9 protection clause as allowing some but not too much reverse discrimination.48 ever since justice powell’s opinion in bakke was submitted, the intellectual foundation of the diversity rationale has been in question. professor calabresi referred to justice powell’s opinion as a “subterfuge.”49 he argued that the appropriate degree of diversity was left to be decided by universities, thereby allowing them to “work out [their] own quiet compromise between our deeply held, but irreconcilable ideals.”50 calabresi discussed the problems with this subterfuge—”the standard universities are to apply— diversity— has been sufficiently used by them in the past to disfavor disadvantaged groups that it should give one pause as to its suitability as the basis for the ‘acceptable,’ if unspoken and unreviewable, decisions of today.”51 reflections of calabresi’s critique that decisions about diversity were deferred to universities were echoed by conservatives, such as brian t. fitzpatrick who, following the decisions in grutter and gratz, made a bold claim that “the university of michigan lied to the supreme court when it claimed it discriminates to obtain the educational benefits of diversity.”52 he substantiated this claim by arguing that the university’s scheme was underinclusive, and that it was insincere because while it purported to create a more lively and enlightened classroom space, it adopted measures to censor certain classroom conversations.53 in a similar vein, law professor jed rubenfeld argued that the universities were not actually pursuing actual diversity, which is why there were no preferences for fundamentalist christians and neo-nazis.54 another robust body of critique comes from scholars who believe that the diversity rationale was a weaker justification for race-conscious admission policies than looking at affirmative action as a method of remediation for america’s history of racism. law professor and scholar melissa murray has written how diversity— as the primary rationale for affirmative action— is unfaithful to the remedial rationales that animated such policies in the first place, and fails to engage deeply with the question of how affirmative action can be a remedy for state-sanctioned oppression.55 in particular, she takes issue with the fact that “thinking about diversity in terms of what beneficiaries might contribute makes the benefits of affirmative action contingent and conditional.”56 law professor randall kennedy also discusses how the supreme court has limited the discourse around reparations-based affirmative action and rendered certain 48. robert h. bork, the unpersuasive bakke decision, wall st. j. 1, 8 (july 21, 1978). 49. guido calabresi, bakke as pseudo-tragedy, 28 cath. univ. l. rev. 427, 430 (1979). 50. id. at 431. 51. id. 52. brian t. fitzpatrick, the diversity lie, 27 harv. l. j. & pub. pol’y 385, 386 (2003). 53. id. at 389-97. 54. jed rubenfeld, affirmative action, 107 yale l. j. 427, 471 (1997). 55. melissa murray, that affirmative action ruling was good. its rationale, terrible, n.y. times (oct. 2, 2019), https://www.nytimes.com/2019/10/02/opinion/harvard-affirmative-action. html [https://perma.cc/uf7f-wmuv]. 56. id. 10 indiana health law review [vol. 20:1 histories as irrelevant— you know, in the latest supreme court affirmative action decision, fisher v. university of texas at austin, the majority opinion never even cites sweatt v. painter. . . in sweatt, a black man applies to be a student at the university of texas law school. the authorities reject him solely because he is black. the dean says, you’re qualified, you’re a good student, but you’re black so you’re ineligible. the supreme court in 1950 orders that he be admitted to the all-white university of texas law school. it says that texas could exclude him on racial grounds if the state could offer to him a separate but equal law school for blacks. but since the state had no equal law school for blacks at hand, sweatt was entitled to attend the white one.57 against this background of various criticisms levied against the diversity rationale, it is evident that the diversity rationale has been controversial since justice powell articulated the rationale in bakke. the brief for sffa argues in support of overruling grutter on three levels: that grutter is grievously wrong, has spawned negative consequences, and generated no legitimate reliance interests.58 a large part of the petitioner’s first argument is that grutter’s diversity rationale flouts equal-protection principles.59 the petitioner’s brief makes arguments about how grutter uses “race as proxy for views” and how such stereotyping doesn’t have a place in today’s society where racial lines are becoming more blurred.60 petitioners also objected to justice o’connor’s deference to universities’ experience.61 one of the petitioners’ main arguments in sffa is that grutter has led to consequences such as discrimination against asian americans.62 in the amicus brief of the pacific legal foundation in support of the petitioner, the amici argue that this discrimination exacerbates a long history of discrimination against asian americans.63 these allegations were denied by harvard in their brief and were not accepted by the lower courts.64 the first circuit held that harvard had identified, in compliance with guidance in fisher ii, specific and measurable goals it sought to achieve by considering race. it found that harvard had considered the khurana committee’s report that set out various goals including training future leaders, allowing productive participation in a pluralistic society, 57. randall l. kennedy & andra gillespie, racial preferences are fair—and they work, bos. rev. (oct. 9, 2013), https://bostonreview.net/articles/gillespie-interview-randall-kennedy/ [https://perma.cc/pw9j-b2u6]. 58. see sffa brief, supra note 19. 59. id. at 50-60. 60. id. at 52-53. 61. id. at 55. 62. id. at 72. 63. brief of pacific legal foundation et al. as amici curiae supporting petitioner, president & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 64. harvard brief, supra note 13, at 42. 2023] gutting grutter 11 and producing knowledge stemming from diverse outlooks.65 b. did the admission policies meet the strict scrutiny standard? in addition to arguing that grutter’s diversity rationale should be overruled, sffa simultaneously argues that if not, the court should still consider the argument that harvard’s policies did not pass strict scrutiny review because they were not narrowly tailored enough to meet the interest of diversity. it should be reiterated that justice o’connor’s opinion in grutter stated that any admissions program that “unduly harmed” members of any racial group would fail to survive strict scrutiny.66 while the admissions policy in grutter was upheld, the policy in gratz v. bollinger was not because the policy awarded students from underrepresented minorities twenty points, making race a decisive factor for almost every candidate from this background, thereby failing to satisfy strict scrutiny.67 in fisher i, the supreme court summarized that an admissions program could not be narrowly tailored, if it involved racial balancing or quotas, and if it uses race as a mechanical plus factor.68 in fisher ii, an addition to the bakke criteria was not only that the university needed to provide evidence that it undertook “serious, good faith consideration of workable race-neutral alternatives” before resorting to its choice of a race-conscious plan, but that those alternatives either did not suffice to meet its approved educational goals or would have required some sacrifice of its “reputation for academic excellence.”69 sffa argued that harvard penalizes asian americans, and in this process, race is used as a “minus factor.” in support of this argument, sffa cited evidence compiled by the harvard office of institutional research (“oir”) that asians were disadvantaged in the admissions process due to harvard’s “personal rating” system and pointed to expert testimony at trial that harvard admitted asian americans at lower rates than whites despite higher academic, extracurricular, and alumni-interview scores.70 sffa alleged that harvard engaged in racial balancing, and pointed to the fact that the percentages of racial groups in harvard’s class by race consistently fell within a narrow range as evidence of this, in addition to its use of “onepagers” that displayed the racial makeup of a class.71 sffa also argued that harvard uses race as a mechanical plus factor, and that it failed to consider raceneutral alternatives such as “simulation d”—an approach that would eliminate the consideration of race, eliminate tips for aldcs, and increase the tip for low65. students for fair admissions, inc. v. president & fellows of harvard college, 980 f.3d 157, 186 (1st cir. 2020). 66. grutter, 539 u.s. at 341. 67. gratz, 539 u.s. at 275. 68. fisher i, 570 u.s. at 311. 69. fisher ii, 579 u.s. at 385. 70. see sffa brief, supra note 19, at 25. 71. id. at 48. 12 indiana health law review [vol. 20:1 income students.72 in affirming the district court’s opinion, the first circuit went step-by-step in challenging sffa’s arguments. the first circuit also concluded that sffa failed to demonstrate discrimination towards asian americans.73 an amicus brief in favor of sffa, filed by a group of economists, found that based on data made available by harvard, “asian americans should do better than whites on the overall rating, but they do worse. african americans and hispanics would be expected to do much worse than whites (and asian americans) on the overall rating, but they do much better.”74 this brief, in addition to reporting findings of discrimination against asian americans, took issue with the reasoning of the first circuit, finding that it “misunderstood basic statistical principles for when an explanatory variable should be included or excluded from a regression model” and that its hypothesis regarding white privilege was dependent on evidence that was not in the record and contradicted the court’s own conclusions.75 with respect to unc, sffa based the main thrust of its argument on alleging that unc had workable race-neutral alternatives, including giving preference to socioeconomically disadvantaged students.76 the district court had argued that this suggested plan would lead to a drop in underrepresented minority admissions and sat scores, but sffa argued that if strict scrutiny had any teeth, “the tiny dips” identified by the district court were not enough to justify the use of explicit racial classifications.77 iii. the importance of diversity in the medical profession in the harvard case oral arguments, justice kagan asked mr. norris, counsel for the petitioner: “if you’re a hospital and you serve a diverse group of patients, is it super-important to you to have a diverse set of doctors?”78 mr. norris responded saying that he did not know about the evidence around diversity of doctors and patients or anything about the medical field.79 this section seeks to shed some light on the benefits of diversity in the medical field. a statement by the american council on education (“ace”) recognizes some as furthering of diversity, which include enrichment of the educational experience, promotion of personal growth by encouraging critical thinking, strengthening of communities, and enhancing competitiveness.80 similar to 72. id. at 33. 73. see president & fellows of harvard college, 980 f.3d at 202. 74. brief of economists as amici curiae supporting petitioners, president & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 75. id. at 18. 76. sffa brief, supra note 19, at 83-86. 77. id. at 84. 78. transcript of oral argument at 27, president & fellows of harvard college (2022) (no. 20-1199). 79. id. 80. on the importance of diversity in higher education, am. council educ. (june 2012), 2023] gutting grutter 13 justice o’connor’s description of diversity as furthering “the common good,”81 an analysis of the benefits of diversity in the medical profession show results beyond those that have been identified. diversity within the medical profession has special significance— due to the nature of the service that medical personnel provide to society— it is important that the workforce reflects the range of patients they serve.82 diversity can ensure that providers understand the unique health issues their patients face and can recognize the roles their racial, ethnic, gender, and class backgrounds play in affecting their health.83 this is particularly crucial because health disparities fall along racial and class lines, and a diverse and culturally competent workforce can respond to the cultural needs of their patients as well as the health needs shaped by their culture.84 in contrast, the lack of a diverse workforce can lead to miscommunication between patients and their providers and to limited perspectives when providing care and support to a diverse population of patients.85 evidence suggests that a diverse medical workforce is associated with improved health outcomes, due in part to cultural competency and promotion of a relationship of trust. for instance, a study on hospital births in florida between the years 1992 and 2015 found that there was an association between newborn infant and physician racial concordance.86 there was reduced infant mortality for black newborn infants, such that the mortality rates for black babies were 0.169 when provided care by black physicians versus 0.318 for those provided care by white physicians.87 studies have also found that minority patients are more likely to choose an under-represented minority (“urm”) physician, and experience more satisfaction regarding care when it is provided by someone from a urm background.88 in the h t tps :/ /w ww .acen e t . edu /d ocu m en t s /b oardd iver s i t ysta t emen t -j u n e2 0 1 2 .pdf [https://perma.cc/62y3-jedv]. 81. see claire andre & manuel velasquez, the common good, 5 issues ethics 1, 2 (1992). 82. the importance of diversity in health care: medical professionals weigh in, st. george’s univ. (aug. 19, 2021), https://www.sgu.edu/blog/medical/pros-discuss-the-importanceof-diversity-in-health-care/ [https://perma.cc/sl6t-u636]. 83. id. 84. see diversity in healthcare and the importance of representation, univ. st. augustine health servs. (mar. 2021), https://www.usa.edu/blog/diversity-in-healthcare/ [https://perma. cc/2hc7-mtde]. 85. the importance of diversity in healthcare & how to promote it, provo. coll. (june 1, 2022), https://www.provocollege.edu/blog/the-importance-of-diversity-in-healthcare-how-topromote-it/ [https://perma.cc/2x25-yhfj]. 86. brad n. greenwood et al., physician–patient racial concordance and disparities in birthing mortality for newborns, 117 proc. natl. acad. sci. 21194, 21194 (2020). 87. id. at 21196. 88. see generally in the nation’s compelling interest: ensuring diversity in the health-care workforce (brian d. smedley et al., eds., 2004). see also lisa cooper et al., patient-centered communication, ratings of care, and concordance of patient and physician 14 indiana health law review [vol. 20:1 same vein, a 2018 study found that african-american men were more likely to participate in preventive services if seen by a black physician.89 additionally, this research also supported the fact that black doctors, compared with non-black doctors, could reduce cardiovascular mortality among black men by 16 deaths per 100,000 per year.90 in addition to benefits directly related to health outcomes, there are other benefits of a diverse medical workforce. data have shown that urm physicians are more likely to care for minority and vulnerable patients,91 including those who are on medicaid and from lower socio-economic classes.92 some studies have also indicated that minority doctors, particularly hispanic doctors, have higher career satisfaction and lower perceived stress when compared to their white peers, which may be associated with lower risks of burnout.93 despite the benefits of a diverse medical workforce, data published by the association of american medical colleges (“aamc”) showed that, in 2018, among active physicians, 56.2% identified as white, 17.1% identified as asian, 5.8% identified as hispanic, and only 5.0% identified as black or african american.94 in 2014, in new york city where 53% of the population was african american or hispanic, data showed that only 12% of practicing physicians were from urms.95 this data highlights the disappointingly low numbers of black and hispanic medical professionals in the workforce. these data points do not seem surprising considering the number of urm matriculants to medical school. in 2018-2019, of accepted applicants, half were white, 22.0% were asian, 7.1% were black or african american, and 6.2% were hispanic, latino, or of spanish origin.96 while there has been a reported increase, observed in 2018, in the number of women and people of diverse racial race, 139 annals internal med. 907, 907 (2003). 89. marcella aslan et al., does diversity matter for health? experimental evidence from oakland 29, nat’l bureau of econ. rsch., (working paper no. 24787) (2018). 90. id. at 8. 91. peter b. bach, primary care physicians who treat blacks and whites, 351 new eng. j. med. 575 (2004); see also sarah e. brotherton et al., minority and nonminority pediatricians’ care of minority and poor children, 154 archives pediatrics & adolescent med. 912, 912 (2000). 92. lyndonna m. marrast, minority physicians’ role in the care of underserved patients: diversifying the physician workforce may be key in addressing health disparities, 174 jama intern. med. 289, 289 (2014). 93. m. maria glymour et al., physician race and ethnicity, professional satisfaction, and work-related stress: results from the physician work life study, 96 j. nat’l med. ass’n 1283, 1288 (2004). 94. diversity in medicine: facts and figures 2019, ass’n am. med. cs. (july 1, 2019), https://www.aamc.org/data-reports/workforce/interactive-data/figure-18-percentage-all-activephysicians-race/ethnicity-2018 [https://perma.cc/d5g8-eelz]. 95. said ibrahim, physician workforce diversity and health equity: it is time for synergy in missions!, 3:1 health equity 601, 601 (2019). 96. diversity in medicine: facts and figures 2019, supra note 94. 2023] gutting grutter 15 groups applying to medical school,97 in the longer-term, the reality is that the number of urm medical students has been declining.98 for example, an aamc report showed that there were fewer black male medical students in 2014 than there were in 1978.99 the declining rates of urm students in the medical field can be explained by many factors. unfortunately, the reality remains that students from minority backgrounds must overcome obstacles through their journeys to becoming doctors. they might experience barriers at every step including gaining admissions into and pursuing undergraduate degrees, during the application process to medical school itself, throughout the duration of attending medical school, as well as barriers caused by the prohibitive cost of attendance.100 if the court prohibits the consideration of race in university admissions, this may make the entry of students of color much harder at the admissions stage for undergraduate degrees and medical schools independently. a smaller pool of racially diverse students at the undergraduate level would also impact the number of urms who go on to join the medical profession. this was confirmed in a study published in 2022 that compared twenty-one public medical schools in eight states with affirmative action bans— compared to thirty-two medical schools in twenty four states without bans between 1985 and 2019.101 this study found that within five years of the implementation of these bans, urm enrollment declined 4.8% in the banned schools, as compared to schools in which affirmative action was not banned.102 another study published in 2015 examined the impact of affirmative action bans in six states on the matriculation rates of historically underrepresented students of color in public medical schools.103 it concluded that affirmative action bans led to a seventeen-percent decline in this population.104 similar rates of decline have been noted in the enrollment of underrepresented students of color 97. id. 98. id. 99. alicia gallegos, aamc report shows decline of black males in medicine, ass’n am. med. cs. (sept. 27, 2016), https://www.aamc.org/news-insights/aamc-report-shows-decline-blackmales-medicine [https://perma.cc/77xd-ampj]. 100. see addressing the challenges to a diverse physician workforce, associated med. sch’s. n.y. (feb. 2020), https://amsny.org/wp-content/uploads/2020/02/addressing-the-challengesto-a-diverse-physician-workforce-amsny-optimized.pdf [https://perma.cc/zd99-n9nu]. 101. dan p ly et al., affirmative action bans and enrollment of students from underrepresented racial and ethnic groups in u.s. public medical schools, annals internal med. (2022), https://www.acpjournals.org/doi/10.7326/m21-4312 [https://perma.cc/cwq4mrgp]. 102. id. 103. liliana m. garces & david mickey-pabello, racial diversity in the medical profession: the impact of affirmative action bans on underrepresented student of color matriculation in medical schools, 86 j. higher educ. 264, 264 (2015), https://www.ncbi.nlm.nih.gov/ pmc/articles/pmc4454423/ [https://perma.cc/22tn-smm7]. 104. id. 16 indiana health law review [vol. 20:1 at some of the most selective public undergraduate institutions as well.105 in their brief opposing the grant of certiorari, harvard university claimed that if it were to abandon all consideration of race in their admissions process, africanamerican and hispanic enrollment would decline from 14% to 6% and 14% to 9%, respectively.106 given the already low numbers of urms in the medical profession, such a steep decline could severely curtail the medical school pipeline and have serious ramifications for public health and the medical workforce. iv. potential outcomes of the sffa litigation and the path forward it is yet to be seen how the supreme court will assess the various arguments made by each party in the sffa lawsuits and what the turning points will be. this section reviews some of the main arguments that may become relevant for the justices and reviews the evidence that may sway the court. this section also details some of the arguments that gained attention during the oral argument in october 2022. how the court deals with allegations of asian american students being disadvantaged may become important to the outcome of the harvard case and the future affirmative action policy. the district court dealt with the issue of asian american discrimination in a footnote, a decision that scholar jeena shah has lamented and argued should have been the primary focus of the court.107 similarly, in the first circuit, judge sandra lynch analyzed harvard’s affirmative action policy separately from the intentional discrimination claim, finding in favor of harvard on both those claims.108 a harvard law review article argues that despite the first circuit’s convincing analysis, it failed to address the relationship between the two claims and did not adequately address sffa’s argument that “an intentional discrimination claim should be part of a race-conscious program’s strict scrutiny analysis.”109 the author of this article argues that “incorporating allegations of intentional discrimination into such analysis would, without precedent, invalidate affirmative action programs unless a defendant can prove that they aren’t biased against any racial minority.”110 arguing that the first circuit accepted such incorporation or merging of these two issues, the article finds that judge lynch’s analysis was “far from the ‘stringent’ narrow tailoring requirement[.]”111 in light of the above, 105. id. 106. brief in opposition at 35, president & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 107. jeena shah, affirming affirmative action by affirming white privilege: sffa v. harvard, 106 geo. l. j. o. 134, 134-135 (2020). 108. president & fellows of harvard college, 980 f.3d at 157. 109. students for fair admissions, inc. v. president & fellows of harvard college—first circuit holds that harvard’s admissions program does not violate the civil rights act, 134 harv. l. rev. 2630, 2634 (2021). 110. id. 111. id. at 2636. 2023] gutting grutter 17 it is important to determine whether asian american discrimination is featured in the court’s analysis in this case, and if so, is it treated as part of the program’s strict scrutiny analysis. in their amicus brief in support of sffa, america first legal foundation argued that the court, instead of seeking to resolve harder constitutional law questions, should look simply to the statutory command of title vi which “prohibits all forms of racial discrimination at universities that accept federal funds, with no exceptions for ‘compelling interests,’ ‘diversity,’ or ‘strict scrutiny’.”112 following justice stevens’ approach in bakke, this brief argues that harvard’s stance, that title vi prohibits only the racially discriminatory acts that would violate the equal protection clause if committed by a state actor, is incorrect.113 this approach would be contingent on following textualist reasoning that has gained traction in recent times.114 it is important to consider how the court reads title vi and whether its reasoning mirrors that of justice stevens or justice brennan in bakke. while this argument did not become too important during oral arguments, justice gorsuch returned to it time and again, even though mr. strawbridge, counsel for the petitioners, claimed that for their purposes, there was not a difference between how the fourteenth amendment should read, and how title vi’s prohibition should read.115 separately from title vi, there is a long-standing question about the scope of the fourteenth amendment and whether it is colorblind in its application. the brief for harvard argues that the equal protection clause does not mandate complete colorblindness.116 an amicus brief filed by professors of history and law disagrees with sffa’s claim that grutter is at odds with the original meaning of the fourteenth amendment and argues that there exists a distinction between racial designations that harm and those that ameliorate discrimination, such that the latter are permissible under the fourteenth amendment.117 similarly, the amicus brief filed by the constitutional accountability center stated that the framers of the fourteenth amendment “time and again rejected proposed constitutional language that would have precluded race-conscious measures designed to assist black americans in their transition to equal citizenship.”118 deep into the oral arguments in the unc case, justice kagan 112. brief of america first legal foundation et al. as amici curiae in support of neither party at 3, students for fair admissions, inc. v. pres. & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 113. id. 114. see adam liptak, a conservative lawyer’s new target after abortion: affirmative action, n.y. times (may 23, 2022), https://www.nytimes.com/2022/05/23/us/politics/supremecourt-affirmative-action.html [https://perma.cc/s44q-43vd]. 115. transcript of oral argument at 55, university of north carolina (2022) (no. 21-707). 116. harvard brief, supra note 13, at 22. 117. brief of professors of history and law as amici curiae supporting respondents at 2, president & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 118. brief of constitutional accountability center as amicus curiae supporting respondents 18 indiana health law review [vol. 20:1 expressed that there had been very little discussion of what originalism suggested about the issue of race-conscious admissions.119 while the conversation on this point was limited, the decision in brown v. board of education was evoked by both sides. mr. strawbridge claimed that the decision “firmly rejected the view that racial classifications have any role to play in providing educational opportunities.”120 but as legal journalists dahlia litwick and mark joseph stern wrote, “sotomayor and jackson reminded their colleagues, this argument is a historical nonsense: the 14th amendment was a color-conscious effort to give black americans all the rights and privileges enjoyed by white americans.”121 it remains to be seen whether and how conservative judges will interpret the fourteenth amendment, and how they will respond to the more progressive originalist questions being raised by justice jackson and her colleagues on the bench.122 another argument that may become relevant is justice o’connor’s statement in her opinion in grutter: “we expect that 25 years from now, the use of racial preferences will no longer be necessary to further the interest approved today.”123 while her reasoning and the motivation behind her statement have been often debated,124 and were raised at the oral arguments in the unc case before the supreme court justice barrett asked: “this -this distance of time, this 50 years since bakke, suggests accurately, i think, that achieving diversity and diverse student populations in universities has been difficult. what if it continues to be difficult in another 25 years? i take it that you, because you’ve repeatedly said that the 25 years is aspirational and you told justice kavanaugh it wasn’t a holding, that you don’t think that university of north carolina has to stop in 25 years, at that 2028 mark. so, what are you saying when you’re up here in 2040? are you still defending it like this is just indefinite, it’s going to keep going on?”125 justice jackson came at the question of the 25-year expiration deadline from at 7, president & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 119. oral argument transcript, supra note 115, at 160. 120. id. at page 4. 121. dahlia lithwick & mark stern, the supreme court has no reason to end affirmative action. they’re doing it anyway, slate (oct. 31, 2022), https://slate.com/news-and-politics/ 2022/10/supreme-court-end-affirmative-action-unc-harvard-why.html [https://perma.cc/y2sfjxce]. 122. see mark joseph stern, hear ketanji brown jackson use progressive originalism to refute alabama’s attack on the voting rights act, slate (oct. 4, 2022), https://slate.com/newsand-politics/2022/10/ketanji-brown-jackson-voting-rights-originalism.html [https://perma.cc/b8fsdtl9]. 123. bollinger, 539 u.s. at 343. 124. see vijay s. sekhon, maintaining the legitimacy of the high court: understanding the “25 years” in grutter v. bollinger, 3 conn. pub. int. l. j. 301(2018). 125. oral argument transcript, supra note 115, at 108. 2023] gutting grutter 19 a different angle and asked about unc’s history of exclusion. this led mr. park to claim that a university’s history is relevant to the diversity analysis because it could help explain why the progress that unc was pursuing was behind another universities. to this answer, justice jackson stated that the “25-year expiration deadline [couldn’t] really be blanketly applied, because we start in different places with respect to how race has been considered to exclude people in -in our various communities.”126 in light of this debate, it is yet to be seen how the court interprets justice o’connor’s statement. both briefs filed by harvard and the university of north carolina (“unc”) argue that the supreme court only revisits precedents when there are compelling reasons to do so, and that sffa has failed to offer a legitimate justification for this extraordinary step.127 in particular, both claim that sffa did not identify any recent factual or legal developments that warranted revisiting the long history of affirmative action jurisprudence.128 if the supreme court decides to overrule grutter, what would be the reasoning for revisiting settled precedent at this point? some scholars who follow the proceedings of the court believe that these cases may signal the end of affirmative action as we know it.129 in fisher ii, justices thomas, alito, and roberts issued dissents to strike down the university of texas’ holistic admission policy.130 these three justices have now been joined by conservative justices gorsuch, kavanaugh, and barrett, tilting the ideological composition of the court. also, justice jackson, during her nomination process, said that she would recuse herself from the harvard case given her previous position on harvard’s board of overseers and that she would therefore only hear the unc case.131 with five conservative justices and only two liberal justices hearing the harvard case, it is uncertain whether harvard can succeed. . . it seems plausible that the court may issue a single opinion from the court applicable to both cases. despite how the court rules, several institutions of higher education have vocalized their support for race-conscious admissions programs, while underscoring the vitality of diversity.132 due to the potential demise of affirmative action, institutions of higher education have already begun strategizing on how 126. id. at 91. 127. see harvard brief, supra note 13; unc brief, supra note 17. 128. harvard brief, supra note 13; unc brief, supra note 17. 129. see ian millihiser, the supreme court will hear two cases that are likely to end affirmative action, vox (jan. 24, 2022), https://www.vox.com/2022/1/24/22526151/supreme-courtaffirmative-action-harvard [https://perma.cc/2umk-dqr8]. 130. see fisher ii, 579 u.s. at 365. 131. see kimberly strawbridge robinson, supreme court decouples harvard, unc affirmative action cases (2), bloomberg (july 22, 2022), https://news.bloomberglaw.com/us-lawweek/supreme-court-separates-affirmative-actions-cases-for-jackson [https://perma.cc/63tky5e2]. 132. see brief of amherst et al. as amici curiae supporting respondent, president & fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 20 indiana health law review [vol. 20:1 they can continue to diversify their university campuses.133 some methods being suggested require making a more concerted effort to recruit from a greater number of high schools that may be geographically diverse and seeking potential students at churches and community centers.134 such strategies have reportedly helped in california, where affirmative action was outlawed in 1996 by proposition 209.135 universities might also consider “race-neutral” alternatives suggested by the petitioners.136 one such alternative would eliminate harvard’s racial preferences while simultaneously eliminating its preferences for aldcs and increasing the socioeconomic boost to one-half that of recruited athletes.137 this approach could be helpful as tips for aldcs come under fire. elie mystal, a journalist, writes that the unfairness of harvard’s treatment of asian american applicants is the proper focus of the lawsuit rather than affirmative action: an internal harvard study, made public during the trial, suggested that if harvard looked only at “academic” factors, asian american students would make up 43 percent of its class, not the 20 percent representation they enjoy now. furthermore, a different study found that 43 percent of white students at harvard were actually legacies, athletes, or kids from families who donated money to the school. you’ve got to have some serious racial hang-ups to read those numbers and conclude that black and brown kids are why your kid didn’t get into school.138 the adoption of race-neutral means will not be without challenge either. for instance, justice kavanaugh in the oral arguments for the unc case asked if it would be permissible for a university to pick a race-neutral alternative if it would lead to the highest number of african american students.139 in response to this, mr. strawbridge responded that if it were the only reason considered, and there was no other race-neutral justification that would have led them to adopt the policy anyway, it would create problems under the court’s precedent.140 to this, justice kagan pressed—”well, that really means it’s not the reason at all. so, you are saying, if the -if -if -if that contributes at all to the decision-making, then 133. see laura krantz, as affirmative action decision looms, colleges look for alternative ways to achieve diversity, bos. globe (may 22, 2022), https://www.bostonglobe.com/2022/05/ 22/metro/affirmative-action-decision-looms-colleges-look-alternative-ways-achievediversity/?s_campaign=8315 [https://perma.cc/3jaw-x8j9]. 134. id. 135. id. 136. see sffa brief, supra note 19, at 80. 137. id. at 81. 138. elie mystal, harvard’s thrilling—and pyrrhic—affirmative action victory, nation (oct. 2, 2019), https://www.thenation.com/article/archive/harvard-affirmative-action/ [https:// perma.cc/9c45-7yjv]. 139. oral argument transcript, supra note 115, at 15. 140. id. 2023] gutting grutter 21 that’s impermissible?”141 this too did not lead to a clear answer about what would be permissible and impermissible, and it would not be surprising if race-neutral means adopted to improve diversity will be litigated separately. in addition to the above recommendations, other methods have been suggested to target the historical white supremacy baked into the admissions process. in their article dismantling the master’s house: establishing a new compelling interest in remedying past discrimination, chris c. goodman and natalie antounian demonstrate how remedying systemic discrimination is equivalent to remedying past and present discrimination and should therefore qualify as a compelling government interest.142 a similar argument was also made in the black women law scholars’ amicus brief filed in the sffa cases that recounted a history in which black people were excluded from the educational institutions that they helped build after the civil war.143 it argues that while the supreme court has recently taken a “stingy view” of the remedial rationale, the fourteenth amendment was “meant for better things” and “was never meant to hamstring university officials from taking commendable steps to remedy the lasting effects of white supremacy and structural racism.”144 harvard university just invested one-hundred million dollars to redress its ties to slavery,145 and measures such as this may be consistent with devising a new compelling interest. that said, since this measure requires the intervention of the courts, it may be hard to accomplish. other more specific steps must also be taken to increase diversity in the medical workforce. in their journal of the american medical association (“jama”) article, diversity in medical schools—need for a new bold approach, clyde w. yancy and howard bauchner side-step conventional affirmative action arguments, and instead support the creation of a new medical school, specifically at a historically black college and university (“hbcu”) to enhance capacity and substantively address the concerns of diversity in the medical profession.146 in support of this proposal, this article cites data showing that the current four medical schools in part aligned with hbcus and serving black medical students represent merely 2.6% of total medical schools, yet 141. id. 142. chris chambers goodman & natalie antounian, dismantling the master’s house: establishing a new compelling interest in remedying systemic discrimination, 73 hastings l. j. 437, 437 (2022). 143. brief of black women law scholars as amici curiae supporting respondent, president and fellows of harvard college, 142 s. ct. 895 (2022) (no. 20-1199). 144. id. at 24. 145. cara j. chang & isabella b. cho, harvard pledges $100 million to redress ties to slavery, crimson (apr. 27, 2022), https://www.thecrimson.com/article/2022/4/27/100-millionendowment-for-slaveryredress/#:~:text=harvard%20committed%20%24100%20million% 20to,by%20university%20president%20lawrence%20s [https://perma.cc/j7ng-pxp7]. 146. clyde w. yancy & howard bauchner, diversity in medical schools—need for a new bold approach, 325 jama 31, 31 (2021). 22 indiana health law review [vol. 20:1 account for 15% of all black medical students.147 conclusion this article has aimed to provide an overview of the litigation led by students for fair admissions against harvard college and the university of north carolina, and to situate it within four decades of litigation around affirmative action. it also discussed the “diversity rationale” and why diversity is important, particularly in the medical workforce. as we await a final decision in the sffa cases, this article provides context on why affirmative action is once again before the court and how the court’s opinion might be influenced by provocative matters of law and policy. 147. id. (citing facts: applicants, matriculants, enrollment, graduates, md-phd, and residency applicants data, assoc. am. med. coll. (2020), https://www.aamc.org/datareports/students-residents/report/facts [https://perma.cc/hk9d-yuj8]). introduction in 1978, a polarizing question appeared before the supreme court in regents of the university of california v. bakke—are universities permitted to consider race as a factor in admissions? justice powell’s controlling opinion found that it could be constitutionally permissible if serving the compelling interest of promoting diversity in higher education. since this decision, over the last four decades, race-conscious admissions policies have been the subject of social, political, and judicial controversy, and have raised questions about the scope of the fourteenth amendment. the admissions policies have also been criticized as sanctions of “reverse-discrimination,” a claim recently made by asian-american students in relation to the students for fair admissions v. president & fellows of harvard college. on january 24, 2022, the supreme court agreed to hear challenges to affirmative action policies in college admissions at harvard university and at the university of north carolina (“unc”). the ca habeas corpus and covid-19: in the midst of a viral pandemic, can the “great writ” provide home supervision to at-risk plaintiff inmates? jake zurschmiede* i. introduction the world health organization declared the novel sars-cov-2 coronavirus (hereinafter “covid-19,” “covid,” or “pandemic”) a global pandemic in march 2020.1 within the span of one summer, all of the top ten clusters of covid-19 in the united states were linked to prisons and jails.2 by october 2020, there were nearly 1,000 covid-related deaths of inmates in prisons and jails, more than the total covid-related deaths from nineteen different states and washington d.c. put together.3 four months later, this total more than doubled to at least 2,400 covid-related deaths among the total american incarcerated population.4 ultimately, by mid-december 2020, one in every five state and federal prisoners had tested positive for covid-19, a rate over four times that of the general population.5 overall, the national covid mortality rate among prisoners has remained approximately 45% higher than the overall rate.6 in march 2020, the center for disease control and prevention (“cdc”) established that spread of the novel coronavirus is transmitted mainly from person-to-person within close, six-foot contact with one another.7 the cdc also advised the spread of the disease occurs via respiratory droplets produced when an infected person coughs or sneezes. according to the cdc, “the droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”8 while the spiking rates among the incarcerated population are significant, the * j.d. candidate, 2022, indiana university robert h. mckinney school of law; b.a., 2019, hanover college. 1. emily widra, visualizing changes in the incarcerated population during covid-19, prison pol’y initiative (sept. 10, 2020), https://www.prisonpolicy.org/blog/2020/09/10/ pandemic_population_changes/ [https://perma.cc/mm9x-hffw]. 2. id. 3. id. 4. a state-by-state look at coronavirus in prisons, marshall project, https://www. themarshallproject .org/2020/05 /01 /a-state-by-state-look-at-coronavirus-in-prisons [https://perma.cc/qmx7-crb8] (last visited feb. 17, 2021). 5. beth schwartzapfel et al., 1 in 5 prisoners in the u.s. has had covid-19, marshall project (dec. 18, 2020, 6:00 am), https://www.themarshallproject.org/2020/12/18/1-in-5prisoners-in-the-u-s-has-had-covid-19 [https://perma.cc/5j8q-7tmz]. 6. id. 7. how covid-19 spreads, ctr. disease control & prevention, https://www.cdc.gov/ coronavirus/2019-ncov/transmission/index.html [https://perma.cc/ell2-9mm3] (last visited feb. 17, 2021). 8. id. 250 indiana health law review [vol. 19:249 underlying statistics of viral transmissibility in federal prisons are staggering.9 the federal prison system currently houses over 140,000 inmates.10 while these federal prisons may appear to be closed environments because prisoners cannot leave and return to the facility on their own volition, prison staff members have the ability to come and go as they please, providing opportunities for the disease to be introduced into a prison.11 federal prisons typically hold hundreds of prisoners who live in close proximity to one another, and in some facilities, prisoners live in dormitory-style housing where many share the same space.12 even if prisoners are housed in individual cells, they typically share the same ventilation system with prisoners in other cells.13 as of june 2021, 240 federal inmates and four bureau of prisons (“bop”) staff members have died from covid-19.14 of the over 100,000 federal inmates who have been tested for covid-19, over 47,000 – almost half – have been positive.15 the bop has placed just over 27,000 inmates on home confinement, which includes prisoners who completed their sentence within that time frame.16 this comprises fewer than 20% of federally incarcerated individuals.17 according to homer venters, an epidemiologist and member of the biden-harris covid-19 health equity task force, these statistics are “likely an undercount of infections in settings where crowding makes it easy for the virus to spread, and inadequate health care leaves populations especially vulnerable.”18 in response to the viral spread of covid-19 among prison populations, congress passed the coronavirus aid, relief, and economic security (“cares”) act, which was executively signed into law on march 27, 2020.19 the cares 9. see covid-19 coronavirus, fed. bureau prisons, https://www.bop.gov/coronavirus/# :~:text=covid%2d19%20cases&text=currently%2c%2044%2c644%20inmates%20and%20 4%2c502,occurred%20while%20on%20home%20confinement [https://perma.cc/2ugr-ekdg] (last visited june 24, 2021). 10. wendy sawyer & peter wagner, mass incarceration: the whole pie 2020, prison pol’y initiative (march 24, 2020), https://www.prisonpolicy.org/reports/pie2020.html [https:// perma.cc/8l6p-f8s3]. over two million americans were incarcerated nationwide per a march 2020 report by prison policy initiative, comprising nearly 700 per every 10,000 u.s. residents. id. 11. maria morris, are our prisons and jails ready for covid-19?, am. civ. liberties union (mar. 6, 2020), https://www.aclu.org/news/prisoners-rights/are-our-prisons-and-jails-readyfor-covid-19/ [https://perma.cc/23qb-edj7]. 12. see id. 13. id. 14. covid-19 coronavirus, supra note 9. 15. id. 16. id. 17. id. 18. rachel harrison, fighting covid behind bars, n.y.u. (mar. 23, 2021) http://www.nyu. edu /about/news-publicat ions/news/2021/march /covid-beh ind-bar s -ven ters.h tml [https://perma.cc/w45b-l2c7] (emphasis added). 19. the cares act works for all americans, u.s. dep’t treasury, https://home.treasury. gov/ policy-issues/cares [https://perma.cc/v3fx-umhq] (last visited nov. 8, 2020). 2022] habeas corpus and covid-19 251 act provided an economic stimulus to u.s. citizens and gave the u.s. attorney general the authority to expand the cohort of inmates who could be considered for release to home confinement.20 home confinement is defined as “any judicially or administratively imposed condition requiring a participant to remain in [their] residence for any portion of the day.”21 those in home confinement are often geographically monitored with the assistance of electronic equipment.22 the attorney general can effectuate an expansion of this cohort upon a finding that “emergency conditions are materially affecting the functioning of the bureau of prisons.”23 the vague nature of the home release of prisoners under the act, however, makes it so that legal professionals, like defense attorneys and nonprofit advocates, such as the american civil liberties union (“aclu”), should make an inquiry into the availability of legal recourse for prisoners to obtain home release. this is especially pertinent to those prisoners with conditions that make them substantially at-risk if they catch the virus. many of these inmates who have not been granted home release under the cares act have brought suit against their federal prisons, oftentimes petitioning the court to recognize the writ of habeas corpus.24 habeas corpus is an ancient common law writ.25 the writ directs the entity that holds an individual in custody to produce that individual before the court.26 this mechanism is used by plaintiff inmates to correct alleged violations of personal liberty through judicial inquiry into the legality of their custody.27 this note regards the potential of current prison inmates who are not covered by or are otherwise excluded from cares act protections to successfully raise a habeas corpus claim to appeal for home confinement on grounds of adverse confinement location or overall condition of an inmate’s confinement. there exists a split between the sixth circuit and the seventh circuit regarding the ability of a court to grant the writ of habeas corpus pursuant to 28 u.s.c. § 2241 on the grounds of conditions of an inmate’s confinement. the sixth circuit has held that plaintiffs can petition for habeas on the grounds of adverse confinement 20. id.; memorandum from att’y gen. william p. barr to dir. bureau prisons (apr. 3, 2020), h t tps:/ /www.bop.gov/coronavirus/docs/bop_memo_home_confinement_april3 .pdf [https://perma.cc/3946-z258]. 21. see jody klein-saffran, electronically monitored home confinement – not a panacea for corrections, but a useful tool, int’l ass’n residential & cmty. alternatives, may/june 1991, 30-1, https://www.bop.gov/resources/research_projects/published_reports/gen_program_ eval/oreprelectronicmon.pdf [https://perma.cc/m2zc-78n4]. 22. id. 23. memorandum from att’y gen. william p. barr, supra note 20; see also the cares act works for all americans, supra note 19. 24. see, e.g., savage v. warden of fci pekin, no. 20-cv-1181, 2020 wl 4060768 (c.d. ill. july 20, 2020). 25. habeas corpus, britannica, https://www.britannica.com/topic/habeas-corpus [https:// perma.cc/c6dp-fggp] (last visited feb. 12, 2021). 26. id. 27. id. 252 indiana health law review [vol. 19:249 conditions, whereas the seventh circuit precludes these plaintiffs from doing so.28 for example, in the recent u.s. district court for the central district of illinois case savage v. warden of pci pekin, the court precluded a plaintiff inmate from covid-justified home confinement on the basis of habeas corpus. the court held that the writ did not apply because the plaintiff, who sought release by petitioning for a habeas writ on the basis of conditions of his confinement, did not challenge the fact or duration of his sentence.29 the aforementioned circuit split arises from the 1973 supreme court decision preiser v. rodriguez, where the court found that a claim against the deprivation of good-time credits that might have led to an early release for the plaintiff inmate was cognizable under habeas corpus jurisdiction for challenging the fact or duration of the plaintiff’s confinement.30 this holding left open the question as to what qualifies as a “condition of confinement.”31 historically, the seventh circuit has stuck with this standard – that habeas corpus can only be brought as to challenge the fact or duration of a sentence, which effectively barred the plaintiff’s covid-related claim in savage.32 conversely, the sixth circuit has held that habeas corpus jurisdiction is available in a specific circumstance – if the conditions of a sentence are so adverse as to effectively challenge the legality of the confinement.33 in other words, the sixth circuit has recognized that habeas jurisdiction is able to cover claims involving conditions of confinement that rise to an extremely adverse level.34 as such, the guiding question of this note centers on the willingness of courts to deem viral pandemic-related dangers as so materially deleterious to inmate health as to comprise the very legality of an inmate’s confinement. while the theory of the sixth circuit’s ruling is that a court that finds a plaintiff inmate to be under such danger is more likely to admit a petition for the writ of habeas corpus, courts have laterally held during the covid-19 pandemic that a plaintiff inmate cannot effectuate a conditions of confinement claim with a petition for the writ of habeas corpus on the basis of pandemic-related dangers.35 this is not to say that hope for plaintiff inmates seeking a habeas writ on the basis of adverse conditions of confinement during the pandemic is completely lost; some jurisdictions do recognize habeas admissibility in conditions of confinement claims and, as such, hold case law that proves more analogous to covid-era claims than courts have recognized. ultimately, the nation continues to deal with a multifaceted viral threat that has lasted more than a calendar year. on its face, an established doctrine like habeas corpus should not only provide a supplemental 28. see preiser v. rodriguez, 411 u.s. 475 (1973) (emphasis added). 29. see warden of fci pekin, 2020 wl 4060768. 30. rodriguez, 411 u.s. at 475. 31. see id. 32. warden of fci pekin, 2020 wl 4060768, at *2. 33. id. at *3. 34. see id. 35. see, e.g., id. see also miller v. beard, no. 21-11, 2021 u.s. dist. lexis 14246, at *4 (e.d. ky. jan. 26, 2021) (emphasis added). 2022] habeas corpus and covid-19 253 option for plaintiff inmates seeking recourse when no other avenue is available, but its admittance in prison health-based claims would provide precedent for any future threat to communal health. the circuit split reveals the theoretical nature behind the potential for habeas corpus to work in providing relief to those federal prisoners not selected for home confinement. before detailing the split, however, this note outlines several factors vital to contextualizing jurisdictional precedent – (a) the definition of habeas corpus; (b) the intersection of covid-19 and the eighth amendment “conditions of confinement” prong; (c) the deficiencies of the former attorney general’s direction to federal prisons; and (d) the inadequacy of compassionate release to cover all aggrieved plaintiff inmates. ii. background information a. the writ of habeas corpus under the authority of 28 u.s.c. § 2241, habeas corpus, otherwise known as the “great writ,” is the legal procedure that keeps the government from holding individuals in detention indefinitely without showing cause.36 per § 2241(a), writs of habeas corpus may be “granted by the supreme court, any justice thereof, the district courts and any circuit judge within their respective jurisdictions.”37 relevant to this note, plaintiff inmates not only petition for the court to grant the writ for the purpose of “judicial review” of their sentence, but often attempt to pair the writ with a conditions of confinement claim under the eighth amendment.38 b. the eighth amendment – conditions of confinement despite the eighth amendment imposing a duty on correctional facilities to provide inmates with health care, the american prison system is generally not administered in a method conducive to providing sufficient or affordable care for at-risk inmates, especially during a viral pandemic.39 as this note principally 36. faqs: what is habeas corpus, cent. const. rts., https://ccrjustice.org/home/getinvolved/tools-resources/fact-sheets-and-faqs/faqs-what-habeas-corpus [https://perma.cc/4bq5v4r5] (last updated jan. 11, 2010). 37. 28 u.s.c. § 2241. 38. habeas corpus, black’s law dictionary (11th ed. 2019) habeas corpus . . . [law latin “that you have the body”] (18c) a writ employed to bring a person before a court, most frequently to ensure that the person's imprisonment or detention is not illegal (habeas corpus ad subjiciendum). in addition to being used to test the legality of an arrest or commitment, the writ may be used to obtain judicial review of (1) the regularity of the extradition process, (2) the right to or amount of bail, or (3) the jurisdiction of a court that has imposed a criminal sentence. 39. jill burke, while america shelters at home, confinement endangers the incarcerated, univ. s. cal. annenberg media (sept. 11, 2020, 9:25 am), http://www.uscannenbergmedia. com/2020/09/11/while-america-shelters-at-home-confinement-endangers-the-incarcerated/ [https://perma.cc/6y4c-qtu4]. 254 indiana health law review [vol. 19:249 concerns a legal theory of recourse for inmates being put at a high risk of contracting the virus due to their communal living arrangements, the eighth amendment analysis of this note addresses only its “conditions of confinement” clause. the amendment stipulates that “[e]xcessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.”40 per supreme court case rhodes v. chapman, “it is unquestioned that ‘[c]onfinement in a prison [. . .] is a form of punishment subject to scrutiny under the eighth amendment standards.’”41 the court further stated that conditions of confinement “must not involve the wanton and unnecessary infliction of pain, nor may they be grossly disproportionate to the severity of the crime warranting imprisonment.”42 the supreme court in wilson v. seiter established that parties who bring conditions of confinement claims must meet both a subjective and objective standard.43 according to the court, before conditions of confinement can qualify as “punishment,” claimants must prove a culpable, “wanton” state of mind on the part of prison officials.44 in the context of general prison conditions, a context relevant to a covid-based inquiry on the preparedness and ability of detention centers to properly handle the dangers of the virus, this culpable state of mind is “deliberate indifference.”45 in farmer v. brennan, the supreme court furthered the definition of “deliberate indifference” as it pertains to eighth amendment conditions of confinement claims.46 the court established that the standard of “deliberate indifference” goes beyond disregarding an “unjustifiably high risk of harm that is either known or so obvious that it should be known.”47 instead, “it requires a finding of recklessness only when a person disregards a risk of harm of which he is aware.”48 further complicating matters for inmates seeking merely adequate conditions of confinement, the legal bar for claims against prison administration for deliberate indifference to serious inmate needs was set high by the supreme court in estelle v. gamble.49 there, the court held that (a) deliberate indifference constitutes the “unnecessary and wanton infliction of pain” barred by the eighth amendment; but (b) the action at bar must exceed an “inadvertent failure to 40. u.s. const. amend. viii, § 2. 41. rhodes v. chapman, 452 u.s. 337, 345 (1981) (quoting hutto v. finney, 437 u.s. 678, 685 (1978)). 42. id. at 347. 43. see wilson v. seiter, 501 u.s. 294 (1991). the subjective prong details that plaintiffs are burdened with proving prison officials failed to create safe conditions for prisoners during the covid-19 pandemic, while the objective prong details the inquiry as to whether deprivation was sufficiently serious for plaintiffs to prevail. id. 44. id. at 297. 45. id. at 303. 46. see farmer v. brennan, 511 u.s. 825 (1994). 47. id. at 836. 48. id. at 837. 49. see estelle v. gamble, 429 u.s. 97 (1976). 2022] habeas corpus and covid-19 255 provide adequate [care]” in order to be found unconstitutional.50 the jurisprudential history of prison conditions of confinement has generally not favored the most physically or financially-vulnerable prisoners, and this precedent does not bode well for a new class of plaintiff inmates seeking recourse in covid-19-related claims.51 for instance, incarcerated individuals are over five times more likely to test positive for covid-19 than the rest of the u.s. population.52 inside prisons, administration has struggled to mitigate the dangers that the virus has brought to the communal health of inmates.53 janet lee walton, president of the coalition for prison reform, advised inmates in a low-security portion of the federal correctional institution of yazoo city, mississippi, to sleep head-to-toe in an attempt to expand their breathing space.54 this was likely the best the inmates could do to mitigate the dangers of viral transmission in their living space, where three inmates shared a cell “no bigger than the average bathroom.”55 in one particular institution in virginia, the lawrenceville correctional center, there is no doctor on-site for large portions of the day, and, as of september 2020, there were no nurses on-site due to understaffing at the institution.56 according to jill burke of usc annenberg media, these accounts “go[] to show that a lack of appropriate [. . .] care for incarcerated people is not a new phenomenon. rather, the covid-19 pandemic is merely exacerbating and exposing a pre-existing problem.”57 task force member homer venters, too, recognizes the poor conditions of confinement shared amongst prison inmates during the pandemic in explaining that “ [. . .] the physical confines of detention settings promote the spread of covid-19.”58 as an exacerbating element of viral transmissibility in these prisons, venters highlights “the manner in which we have filled carceral settings with high-risk people, those with physical and behavioral problems, and people who are older.”59 similarly, the negative impact of the viral pandemic on prison operations has caused judicial protocol to be compromised.60 due to a state ordinance, new york defense attorneys could not visit their imprisoned clients from mid-march to mid-july, and with the indefinite future of the virus, there is no guarantee that such inhibitions on in-person contact will not reappear.61 while recognizing the 50. id. at 105-106. 51. see burke, supra note 39. 52. id. 53. see id. 54. id. 55. id. 56. id. 57. id. 58. harrison, supra note 18. 59. id. 60. see burke, supra note 39. 61. id. (explaining that many requirements for constitutionality in new york were compromised during its judicial system shutdown in the summer of 2020, as the guarantee of a person being arrested on a felony to appear before a judge in a preliminary hearing within 128 256 indiana health law review [vol. 19:249 difficulty of such a process to continue when workplace congregation poses a threat to communal health in the midst of a viral pandemic, this also means that someone who was arrested on a high-level felony in mid-march would have sat in jail until mid-july without a preliminary hearing, which is a violation of a basic constitutional right.62 in the chance that a preliminary hearing would result in a favorable finding for the accused, a four-month incarceration is at stake, at which time the individual would be exposed to a close and communal living space during a viral threat deleterious to their own health. while the pandemic has matured over the course of a year, society is still at the precipice of how to properly deal with its dangers. as it pertains to the american prison system and the fragility of current prison preparedness to deal with the ramifications of a quickly moving virus, legal professionals should seek alternative means and theories in advocating for inmates, including release and home confinement. venters identifies release as the most imperative means by which to mitigate the spread of the virus in prison settings.63 venters’ concept of release involves “working to identify high-risk people who are close to release dates or otherwise can be released without public safety concerns.”64 such a system, according to venters, “decreases [inmates’] risk of contracting and dying from covid-19, as well as increasing the ability of facilities to manage outbreaks.”65 c. the barr memos in late march 2020, former u.s. attorney general william barr issued memoranda and other communications directing the bop in its handling of inmate relocation per the cares act.66 these communications established an overall plan, but for the forthcoming reasons may have lacked the specificity required to insulate that plan from under-inclusiveness (which is to say that fewer inmates were covered by the plan than was intended) and disparate impact concerns. in his march 26, 2020 memo, the former attorney general outlined a non-exhaustive list of discretionary factors to the bop director to be used by federal facilities in determining which inmates should be granted home confinement.67 this list includes inmate age, vulnerability, conduct in prison, propensity for recidivism, and the nature of the inmate’s conviction.68 barr also hours of the arrest was “thrown out the window”). 62. id. 63. harrison, supra note 18. 64. id. 65. id. 66. see memorandum from att’y gen. william p. barr to dr. bureau prisons (mar. 26, 2020), https://www.bop.gov/coronavirus/docs/bop_memo_home_confinement.pdf [https://perma.cc/ugj9-xm74]. 67. id. 68. id. barr listed the following relevant factors: (a) “the age and vulnerability of the inmate to covid-19, in accordance with the centers for disease control (cdc) guidelines; 2022] habeas corpus and covid-19 257 detailed in his march 26 memo that inmates transferred to home confinement under this process would also be subject to location monitoring technology while in home detention.69 by confining prisoners to their homes or community supervision facilities, this location monitoring requirement works to curb the legitimate threat of over-inclusivity of home release (which is to say that more inmates were covered by the plan than was intended); that releasing prisoners en masse would create a less safe public sphere.70 in his april 3, 2020 memorandum to the bop director, barr explained that the cares act vested his office with the authority to expand the cohort of inmates who can be considered for home release, albeit predicated on his finding that emergency conditions are “materially affecting the functioning of the bureau of prisons.”71 finding this material danger, barr proceeded to advise the bop to give priority in granting home confinement to “the most vulnerable inmates at the most affected facilities.”72 barr detailed that inmates are to be chosen by a less restrictive standard than outlined by the cares act in those facilities which pose a material threat to bop operations.73 he further stated that the extent by which an inmate’s medical inhibitions are to be evaluated should be consistent with cdc regulations, and that any prisoner granted release is subject to a fourteenday quarantine at an appropriate bop facility or, when deemed appropriate on a case-by-case basis, in the residence of the inmate.74 in doing so, the office of the attorney general (“oag”) put a majority of the weight of authority in deciding qualification for release in the hands of the bop.75 barr delegated to the bop the (b) the security level of the facility currently holding the inmate, with priority given to inmates residing in low and minimum security facilities; (c) the inmate’s conduct in prison, with inmates who have engaged in violent or gang-related activity in prison or who have incurred a bop violation within the last year not receiving priority treatment under this memorandum; (d) the inmate’s score under pattern, with inmates who have anything above a minimum score not receiving priority treatment under this memorandum; (e) whether the inmate has a demonstrated and verifiable re-entry plan that will prevent recidivism and maximize public safety, including verification that the conditions under which the inmate would be confined upon release would present a lower risk of contracting covid-19 than the inmate would face in his or her bop facility; (f) the inmate’s crime of conviction, and assessment of the danger posed by the inmate to the community. some offenses, such as sex offenses, will render an inmate ineligible for home detention. other serious offenses should weigh more heavily against consideration for home detention.” 69. id. 70. id. (emphasis added). 71. memorandum from att’y gen. william p. barr, supra note 20. 72. id. 73. id. 74. id. 75. id. 258 indiana health law review [vol. 19:249 task of providing supervision to its facilities in a manner consistent with the attorney general’s guidance, stating too that federal institutions will exert different levels of operative action based on (a) the quality and amount of their resources; and (b) the ability of their staff.76 here, even barr lamented that there is facially no way to guarantee that every federal institution will follow a uniform protocol in deciding which inmates qualify under, albeit, a more inclusive oag standard of review.77 ironically, such lack of uniformity allows for an underinclusiveness that leaves otherwise-eligible inmates without recourse in being granted home confinement based on individual risk factors. the federal prison system has reason, too, to limit the inclusivity of eligible prisoners.78 in his memorandum, barr warned against releasing prison populations “en masse onto the streets,” as doing so, according to barr, “would pose profound risks to the public from released prisoners engaging in additional criminal activity, potentially including violence or heinous sex offenses.”79 barr characterized the decision-making vested in the bop as needing to be of the “careful, individualized determinations bop makes in the typical case” in order to curb the chance that prisoners that are more prone to recidivism would not be granted release.80 the attorney general’s office labeled the determination of who has to stay and who gets to be partially released among the inmate population as needing to be “careful” and “individualized.”81 here, even when considering the criteria for release, it follows that barr has given vague guidance as to how the bop is to make these determinations.82 barr’s direction to the bop may impede homer venters’ vision of sweeping equitable release.83 as argued by eli hager of the marshall project, barr’s home confinement plan “may exclude many vulnerable prisoners from being released, and may also create racial disparities in who gets out of prison.”84 in barr’s fourth prong of the march 26 memorandum list of factors to determine which prisoners qualify for home confinement, he “instructs the prison system to prioritize for release only those inmates who receive” the lowest possible score on pattern (prisoner assessment tool targeting estimated risk and needs).85 pattern is a computerized “risk assessment” algorithm that deems white-collar offenders 76. id. 77. id. 78. see id. 79. id. 80. id. 81. id. 82. see id. 83. see harrison, supra note 18 (explaining that venters’ concept of release involves “working to identify high-risk people who are close to release dates or otherwise can be released without public safety concerns”). 84. eli hager, how bill barr’s covid-19 prisoner release plan could favor white people, colorlines (apr. 2, 2020, 10:05 am), https://www.colorlines.com/articles/how-bill-barrs-covid19-prisoner-release-plan-could-favor-white-people [https://perma.cc/kl32-smzf]. 85. id. 2022] habeas corpus and covid-19 259 generally safe to be let out of prison.86 conversely, those incarcerated on drug charges or with a series of prior arrests face a less favorable outcome from the pattern system.87 on this standard alone, the department of justice (“doj”) has determined that use of the pattern system has a disparately negative impact on the black community.88 according to the doj, only 7% of black men in federal prisons would be granted home confinement through pattern, whereas 30% of white men in federal prisons would be granted home confinement.89 further, the pattern algorithm had not been “fully tested or independently reviewed” prior to its use as a determining factor in the potential home release of federal inmates due to pandemic-related dangers.90 hager reported that, while less algorithmic and more circumstantial factors – including age, health, good conduct, and length of sentence–are included in barr’s march 26 memo, “they would be overruled by a poor score on the pattern assessment."91 seeing as though the doj found that the pattern test operationally favors white prisoners who seek home confinement, it follows that the inclusion of the algorithm in bop’s greater assessment of who qualifies for home release underrepresents black, indigenous, and people of color (“bipoc”) federal prisoners.92 d. compassionate release thus far, inmates have principally relied on motions for compassionate release in order to prevail when requesting home confinement, but their results have been overwhelmingly unfruitful.93 in the first three months of the covid19 pandemic, over 10,000 federal inmates applied for compassionate release.94 only 156 of these requests, or fewer than 2%, were approved.95 just over 2,000 new jersey inmates, all of whom had less than a year remaining on their sentence, were released in november 2020, but this class of prisoners had to wait eight months after the pandemic began.96 for the forthcoming reasons, many inmates who lack a specific combination of qualifications may be without luck in motions for compassionate release, as the bar to relief set by the relevant federal statute has remained high. in the recent 86. id. 87. id. 88. see the first step act of 2018: risk and needs assessment system, u.s. dep’t just. off. att’y gen. (july 19, 2019), https://nij.ojp.gov/sites/g/files/xyckuh171/files/media/document/thefirst-step-act-of-2018-risk-and-needs-assessment-system_1.pdf [https://perma.cc/2cbu-h6q8]. 89. id. 90. hager, supra note 84. 91. id. 92. id. 93. schwartzapfel et al., supra note 5. 94. id. 95. id. 96. id. 260 indiana health law review [vol. 19:249 u.s. district court for the eastern district of michigan case, samy v. united states, the plaintiff inmate was able to prevail on a motion for compassionate release by satisfying two elements – (a) an exhaustion of administrative remedies; and (b) the showing of extraordinary and compelling reasons for release.97 the court held that the plaintiff, an incarcerated medical doctor, satisfied the first statutory element in part because he had “petitioned the bop for compassionate release at least six times, at every administrative level.”98 additionally, the court held that the plaintiff satisfied the second statutory element by explaining that continuing his incarceration under the current pandemic could be a “lethal decision” when factoring in the plaintiff’s age of 72 years, heart condition, diabetes, and asthma.99 while the court furnished the plaintiff inmate with a favorable decision here, his case was undoubtedly helped by facts supporting both statutory elements that may not mirror or even resemble those of other inmates seeking compassionate release. while samy met an exception to the “exhaustion of administrative remedies” prong, other inmates seeking recourse may not be able to show such a record of filings.100 this is especially true when considering that those seeking release due to pandemic-imposed dangers are likely doing so in as short of a period of time as allowable, so as to limit exposure to adverse conditions.101 while the court in samy did recognize the danger of viral transmission posed to those in a communal setting, the plaintiff’s showing of three different underlying medical conditions helped the court reason with the his legal theory.102 under this standard, a plaintiff inmate who shows anything less than a combination of underlying health conditions may have a more difficult time being granted compassionate release under the statute. this, again, brings about the necessity of an inquiry into alternate means by which at-risk inmates may be granted proper release in the midst of a viral pandemic. iii. circuit split and jurisdictional support a. seventh circuit “fact or duration” standard – a blockade to habeas relief exists, but the blockade is not as strong as we think while the seventh circuit is rich with case law that establishes the jurisdictional precedent of allowing habeas petitions only under a challenge to the “fact or duration” of a sentence, it has yet to face a question or controversy where conditions of confinement are so adverse as to challenge the “fact or duration” of the sentence.103 for example, in waletzki v. keohane, the seventh circuit found 97. see samy v. u.s., no. 16-20610-1, 2020 wl 1888842 (e.d. mich. apr. 16, 2020). 98. id. at *6. 99. id. at *10. 100. id. at *6. 101. see id. 102. id. at *8. 103. see savage v. warden of fci pekin, no. 20-cv-1181, 2020 wl 4060768 (c.d. ill. july 20, 2020). 2022] habeas corpus and covid-19 261 that, while the plaintiff inmate’s claim for habeas-based release was within the habeas corpus jurisdiction of the district court, the plaintiff’s claim did not succeed on the merits.104 rather, the court held it should not intervene in policing the exercise of the prison officials’ discretion in awarding “good-time” credits based on performance.105 according to the court, if the decision at bar to deny the plaintiff inmate good-time credits had been on the basis of religion, race, or “some other constitutionally forbidden criterion,” the court would have intervened, but nothing of that sort was alleged.106 similarly, in robinson v. sherrod, a district court within the seventh circuit held that the federal habeas corpus statute cannot be used to challenge conditions of one’s confinement.107 on appeal, the circuit court affirmed the holding, finding that the plaintiff inmate could not bring a § 2241 habeas petition, as none of the alleged failures on the part of prison staff had even an indirect effect on duration of punishment.108 in glaus v. anderson, a prisoner suffering from hepatitis c who stopped receiving treatment from the institution could not prevail on his habeas corpus claim.109 the court reasoned that glaus’s habeas petition would have been proper had release been “among the possible remedies for an eighth amendment deliberate indifference claim.”110 the seventh circuit’s precedent on the matter dictated that claims for the conditions of confinement are not covered under habeas, so the court found glaus’s complaint to be only potentially cognizable under a civil rights or a federal tort claim act-based claim.111 glaus nevertheless cited preiser and the circuit split in arguing that there is a potential for the court to grant his petition for habeas corpus.112 on this matter, the court stated, “[w]hile the supreme court has left the door open a crack for habeas corpus claims challenging prison conditions, it has never found anything that qualified.”113 it is not as if plaintiff inmates have not asked the seventh circuit to adopt a more habeas-friendly approach to covid-19-based claims.114 while merely a district court case, in maday v. fluke, a wisconsin prisoner incarcerated in a south dakota prison brought a petition for the writ of habeas corpus based on his claim that the institution had not enacted safety measures to prevent the spread of the virus.115 the prisoner further claimed that he had underlying health 104. waletzki v. keohane, 13 f.3d 1079, 1081 (7th cir. 1994). 105. id. at 1082. 106. id. 107. robinson v. sherrod, 631 f.3d 839, 840-41 (7th cir. 2011). 108. id. at 843. the plaintiff brought the action on the grounds of the prison apparently failing to investigate his complaints of back pain, failing to schedule for him a diagnostic mri, and failing to administer to him appropriate medication. 109. see glaus v. anderson, 408 f.3d 382 (7th cir. 2005). 110. id. at 387. 111. id. 112. id. 113. id. 114. see maday v. fluke, no. 20-cv343, 2020 wl 2769486 (w.d. wis. may 28, 2020). 115. see id. 262 indiana health law review [vol. 19:249 concerns that would make contracting the virus particularly deleterious to his health.116 in a motion for reconsideration, the prisoner asked the court to adopt the reasoning of courts outside the seventh circuit in their more favorable handling of habeas corpus as a means of relief in conditions of confinement cases.117 denying the prisoner’s request for reconsideration, the district judge made clear that “an eighth amendment conditions of confinement claim cannot be raised in a habeas petition, because release is not an available remedy to an eighth amendment claim.”118 further, the judge reiterated that the seventh circuit had not made an exception to its preclusion of habeas petitions for challenges to the condition of confinement.119 the question here becomes whether the danger of covid-19 viral transmissibility in prisons qualifies as a condition of confinement adverse enough to challenge the “fact or duration” of an inmate’s sentence. referencing glaus v. anderson, despite the supreme court not finding a circumstance or pattern of facts justifying the establishment of an affirmative stance on the ability of habeas corpus to be used in a claim of adverse conditions of confinement, it has nevertheless “left the door open a crack.”120 despite unfavorable findings for the plaintiff inmates in savage and maday, this “crack” could be wide enough for covid-19 to fit in. in theory, the covid-19 viral pandemic is such a categorically different threat than anything the american prison system has seen. the threat is exacerbated by the viral transmissibility at play, which hits hardest to those in close quarters, like in a prison.121 considering waletzki v. keohane, too, the threat of potentially deadly viral transmission must rise above a claim for release based on the revocation of good-time credits, as the former pertains to potentially dire life-or-death circumstances. naturally, an adverse finding would more significantly affect the constitutional rights of the aggrieved inmate housed in a covid “hotspot” than it would affect a prisoner denied of good-time credits.122 the same can be said, too, when considering the plaintiff inmate’s back pain in robinson v. sherrod.123 in a word, the mere life-or-death ramifications of relegating an individual to habitation in an environment adverse to public health must squeeze through the “crack” left by the supreme court in preiser. it follows that this could at least raise the possibility that habeas can work to provide recourse for plaintiff inmates in a covid context. the sixth circuit, in fact, has taken the more habeas-friendly approach to the split, and has historically allowed habeas to fit into the jurisprudential scheme.124 as a result, covid-era cases that 116. id. at *1. 117. id. 118. id. 119. id. 120. glaus v. anderson, 408 f.3d 382, 387 (7th cir. 2005). 121. burke, supra note 39. 122. waletzki v. keohane, 13 f.3d 1079, 1081 (7th cir. 1994). 123. see robinson v. sherrod, 631 f.3d 839, 840-41 (7th cir. 2011). 124. see, e.g., savage v. warden of fci pekin, no. 20-cv-1181, 2020 wl 4060768 (c.d. ill. july 20, 2020). 2022] habeas corpus and covid-19 263 have arisen out of the sixth circuit should provide a model for other jurisdictions that have retained a strict construction of habeas corpus. b. sixth circuit “legality” standard – the theory of why habeas should work in the sixth circuit unlike the cases arising from the seventh circuit, the following cases form the basis of the habeas-friendly sixth circuit as it pertains to the savage decision, which theoretically would provide recourse for plaintiff inmates challenging the very legality of their sentence under materially adverse conditions of confinement. while not dealing with covid-era controversies, the foregoing case provides a framework for the sixth circuit’s approach to habeas corpus that affirms, “where no set of conditions would be constitutionally sufficient, habeas is appropriate because the claim challenges the fact or extent [. . .] of the confinement.”125 in adams v. bradshaw, an ohio death-row inmate challenged the state’s method of execution, which involved lethal injection, by arguing that it was a violation of his eighth amendment rights.126 the plaintiff brought a claim for federal habeas corpus-based relief, which the court held was jurisdictionally cognizable.127 while lethal injection as a procedure for capital punishment is not facially analogous to conditions of confinement in a covid context, both circumstances involve the consequence of death, albeit to differing extremities. while death is no guarantee when catching the novel coronavirus, the chance of fatality increases in individuals with specific risk factors and pre-existing medical proclivities.128 this common thread of fatality, however, raises the stakes in broadening the scope of doctrines on which the aggrieved may rely. this broadened scope should help high-risk prisoners in the sixth circuit, coupled with the authority of the forthcoming case. the holding of this sixth circuit in wilson v. williams provides a small glimmer of hope for plaintiff inmates looking to gain covid-based recourse on habeas claims.129 while the court found that the class-action plaintiffs would likely struggle to prove the subjective prong of eighth amendment deliberate indifference, habeas corpus jurisdiction would have, in fact, existed for the claims made by the plaintiff class had congress not ratified the cares act, which has thus far worked as a lateral blockade to habeas jurisdiction in conditions of confinement claims (to be discussed further in this note).130 the unusual facts of 125. id. at *3. 126. see adams v. bradshaw, 644 f.3d 481 (6th cir. 2011). 127. id. at 483. 128. people with certain medical conditions, ctr. disease control & prevention, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medicalconditions.html [https://perma.cc/8pku-b783] (last visited nov. 7, 2020). 129. see wilson v. williams, 961 f.3d 829 (6th cir. 2020). 130. see id. the subjective prong details that plaintiffs are burdened with proving that prison officials failed to create safe conditions for prisoners in the midst of the covid-19 pandemic. id.; 264 indiana health law review [vol. 19:249 this case should not distract from the vehicle this holding provides for habeas admissibility in covid-based cases. while the court did establish that “even if the bop's response has been inadequate, it has not disregarded a known risk or failed to take any steps to address the risk,” the court still recognized the admissibility of an emergency habeas corpus petition on the strength of the sixth circuit’s precedent in recognizing habeas in conditions of confinement claims.131 had prison administration materially disregarded the threat of the virus and taken no steps to mitigate its dangers, the habeas petition may have worked in concert with the eighth amendment. this, in turn, would have produced a favorable outcome for the class of medically vulnerable plaintiff inmates. plaintiff inmates, therefore, would be burdened with showing that conditions in prisons are so adverse to the extent that “no set of conditions would be constitutionally sufficient.”132 pairing (a) a jurisdictional tolerance for habeas corpus in claims either regarding the location of confinement or involving facts so egregious as to call the constitutionality of the confinement into question with (b) a closer look by courts into the degree to which prison administration attempts to mitigate viral dangers would produce a more favorable landscape for plaintiff inmates. the sixth circuit is also not entirely alone in theoretical habeas-friendliness. c. second circuit writ recognition for bail the split on the matter of habeas corpus admissibility in conditions of confinement claims does not pertain only to the sixth and seventh circuits. reflective of the high degree to which the virus has affected new york city and much of the surrounding northeast, the second circuit is rich with recent case law involving plaintiff inmates’ attempts to petition for bail through a number of legal theories – paramount of which involves habeas corpus petitions under § 2241.133 while primarily dealing with petitions for release on bail and not necessarily home confinement, this recent influx of legal controversies on the matter of prisons and viral transmission in the second circuit reflects the sixth circuit’s habeas-friendly approach.134 since the beginning of the viral pandemic, the second circuit has not been afraid to hear petitions for habeas corpus based on dangers posed by communal living.135 in martinez-brooks v. easter, decided by the u.s. district court for the district of connecticut, four inmates with covid-19 risk factors filed a petition for writ of habeas corpus under § 2241 against both the institution’s warden and see, e.g., miller v. beard, no. 21-11, 2021 u.s. dist. lexis 14246 (e.d. ky. jan. 26, 2021). 131. id. at *843. 132. id. at *838. 133. see, e.g., martinez-brooks v. easter, no. 20-cv-00569, 2020 u.s. dist. lexis 94038, at *4-5 (d. conn. may 29, 2020); basank v. decker, no. 20 civ. 2518, 2020 u.s. dist. lexis 72178, at *27 (s.d. n.y. apr. 23, 2020). 134. id. 135. id. 2022] habeas corpus and covid-19 265 the bop director.136 the inmates made a preliminary showing that officials at the institution made only limited use of the home confinement authority vested in them by barr’s memorandum. the inmates also showed that the failure of administration to “downsize immediately the incarcerated population and [. . .] to undertake aggressively the detection, prevention, and treatment measures that public health and medical experts have recommended, including effective social distancing” amount to deliberate indifference to a substantial risk of serious harm to inmates in violation of the eighth amendment.137 the plaintiff inmates brought other issues which raised factual disputes that precluded the court from granting relief outside of a temporary restraining order, but led to a quicker posting of bail.138 the court did, however, grant an order that requires the warden to adopt a more efficient and clearly-focused process for evaluating the home confinement merits of inmates with risk factors.139 while dealing solely with a controversy surrounding bail, this case is apposite to the sixth circuit in that habeas-friendly adjudication can theoretically apply to covid-era cases. despite the respondents’ argument that the court lacked jurisdiction over the habeas petition and that the plaintiffs failed to state a claim, the court explained that the respondents cited neither a supreme court nor a second circuit decision suggesting that release is unavailable to a § 2241 petitioner asserting an eighth amendment claim.140 the court further explained that, per authority from mapp v. reno, the second circuit affords bail “in unusual cases, or when extraordinary or exceptional circumstances exist which make the grant of bail necessary to make the habeas remedy effective.”141 per the court’s holding in martinez-brooks, it seems that plaintiff inmates in the second circuit are able to raise a habeas corpus § 2241 claim for bail. this holds as long as they can prove that the insufficiency of prison administration in following proper protocol is an “extraordinary or exceptional circumstance,” and that the habeas remedy is only effective when the grant of bail is made.142 since the beginning of the viral pandemic, plaintiff inmates in the second circuit have relied on this authority in order to successfully petition for § 2241 for the purpose of bail, and two primary cases emerged from the circuit that demonstrate the value of petitioning for habeas corpus in such a circumstance. in basank v. decker, decided by the u.s. district court for the southern district of new york, the court found that the inmate petitioners established their entitlement to a preliminary injunction, and further found that detainees in the 136. martinez-brooks, 2020 u.s. dist. lexis 94038, at *4-5. the inmates were held at the danbury federal correctional institution, the low-security prison in connecticut that experienced the covid-19 outbreak that triggered attorney general barr’s memoranda to the bop. 137. id. 138. id. at *3-4. 139. id. 140. id. at *4. 141. mapp v. reno, 241 f.3d 221, 226 (2d cir. 2001). 142. martinez-brooks, 2020 u.s. dist. lexis 94038, at *9. 266 indiana health law review [vol. 19:249 facility at bar were not required to practice social distancing.143 the court further stated that, even if the petitioners had not met the requirements for a preliminary injunction, they would likely be released on bail pending final resolution of their habeas remedy.144 staying consistent with the standard set in mapp v. reno, the court held that releasing the petitioners from confinement was necessary to “make the habeas remedy effective.”145 if the high-risk petitioners were to remain detained, “they would face a significant risk that they would contract covid-19, the very outcome they seek to avoid.”146 just as the second circuit has historically held that severe health issues have been the prototypical case of “extraordinary circumstances” that justify release under habeas corpus, the aforementioned circumstance involving the grave nature of allowing plaintiff inmates to live in adverse conditions also qualifies.147 finally, in fellow southern district of new york case coronel v. decker, the petitioners were detained by u.s. immigration and customs enforcement (“ice”) and subsequently placed in a facility.148 this occurred despite each of the petitioners having medical conditions that put them at risk of catching the virus.149 in a departure from the prior two cases but providing a callback to claims made along the vein of the eighth amendment guarantee of livable conditions of confinement, the petitioners here brought a claim for deliberate indifference against the government for placing them in a high-risk arrangement despite their medical issues.150 the court reaffirmed the merit of the deliberate indifference claim, stating that the goal of the claim was “to ensure constitutionally adequate protection from covid-19 in light of petitioners’ underlying health conditions.”151 as was the case in basank, the court found that “there is a likelihood that petitioners are being subjected to unconstitutional conditions of confinement, and that the risks posed by covid-19 are imminent.”152 the court therefore found that these risks made release on bail necessary to “make the habeas remedy effective.”153 on its face, this looks great for plaintiff inmates not necessarily covered by the cares act; when paired with an eighth amendment conditions of confinement claim to effectuate release on bail, the habeas writ 143. basank v. decker, no. 20 civ. 2518, 2020 u.s. dist. lexis 72178, at *27 (s.d. n.y. apr. 23, 2020). those detainees who exhibited covid-19 symptoms, the court found, often waited to receive medical attention, were not separated from cell mates, and may have been returned to the general population anyway. 144. id. 145. id. (quoting mapp, 241 f.3d at 226). 146. id. at *35. 147. id. at *34. 148. coronel v. decker, 449 f. supp. 3d 274, 289 (s.d. n.y. 2020). 149. id. 150. id. 151. id. 152. id. 153. id. 2022] habeas corpus and covid-19 267 seems to do its job.154 however, while habeas jurisdiction is cognizable for bail in the second circuit, the question remains whether the writ in practice effectuates home confinement for those serving sentences in federal prisons. iv. has habeas corpus actually moved a prisoner’s sentence to home confinement? thus far, no court in any jurisdiction, including the sixth circuit, has recognized habeas corpus as a proper means of attaining home confinement in an eighth amendment covid-based claim. in such cases, courts have laterally held that the standard of release to home confinement, as prescribed by former attorney general barr, cannot be sidestepped by a § 2241 claim.155 despite roughly 20,000 federal inmates having been granted home confinement since march 2020, the fact remains that over 46% of federal inmates have contracted the novel coronavirus, and at least 240 federal inmates and even a few bop staff members have died from contracting the virus.156 despite being from the sixth circuit, the court in the january 2021 case miller v. beard out of the eastern district of kentucky, northern division denied the plaintiff’s petition for the writ of habeas corpus based on pandemic-related dangers.157 miller is far from the only instance of petition denial in the sixth circuit or otherwise, as no court has allowed for the writ of habeas corpus to provide relief for plaintiff inmates during the pandemic. in this case, plaintiff miller – an inmate at f.c.i. ashland (kentucky) – asserted that prison officials are “not doing enough to combat the spread of covid-19 at the prison,” and have not “adequately utilized the authority conferred upon them by the [cares] act to transfer inmates to home confinement or to grant compassionate release.”158 miller further requested that the court order bop officials to release more inmates at f.c.i. ashland through the avenues allowed by the cares act, and to be excused from the requirement of exhausting administrative remedies prior to filing suit under a § 2241 claim.159 under fazzini v. ne. ohio correctional center, a prisoner must exhaust their administrative remedies with the bop before seeking habeas relief under § 2241.160 therefore, aggrieved prisoners, like miller, must file an inmate grievance regarding their concerns and further pursue an appeal process under the bop’s inmate grievance program.161 miller sought exclusion from the exhaustion 154. see basank v. decker, no. 20 civ. 2518, 2020 u.s. dist. lexis 72178 (s.d. n.y. apr. 23, 2020); see also coronel v. decker, 449 f. supp. 3d 274 (s.d. n.y. 2020). 155. see, e.g., miller v. beard, no. 21-11, 2021 u.s. dist. lexis 14246 (e.d. ky. jan. 26, 2021). 156. covid-19 coronavirus, supra note 9. 157. see miller, 2021 u.s. dist. lexis 14246. 158. id. at *3. 159. id. 160. fazzini v. ne. ohio correctional ctr., 473 f.3d 229, 231 (6th cir. 2006). 161. see id. 268 indiana health law review [vol. 19:249 requirement “because of the dangerous conditions at f.c.i. ashland.”162 this is to say that miller thought it deleterious to his health and that of fellow inmates to wait through an administrative process when viral threats perpetuated in their living quarters.163 the court denied miller’s petition because, while the cares act authorizes the bop to consider placing an inmate in home confinement, “it does not require it to do so.”164 the bop has absolute power in making this determination; while the american procedures act usually provides an avenue for judicial review of these decisions, 28 u.s.c. § 3625 exempts the bop’s placement decisions from this review.165 the court further stated that “a prisoner may not invoke the court’s habeas corpus jurisdiction in an effort to sidestep the limitations and requirements of the cares act.”166 even if miller had (a) formalized an eight amendment argument surrounding his claim that prison officials had not “done enough” to contain the virus; (b) asserted that prison officials exhibited “deliberate indifference” in inadequately protecting the facility’s prisoner population from viral threats; and (c) used a petition for the writ of habeas corpus to effectuate home release, the inability of a prisoner to invoke habeas corpus jurisdiction to sidestep the requirements of the cares act would have precluded miller from relief anyway. this is but one example of habeas not working the way that the habeas-friendly side of the circuit split made it seem like it would. a fellow district court case in the sixth circuit, woods v. beard, concluded in the denial of the writ of habeas corpus to another inmate a month prior to the miller case on identical grounds.167 even the court in the aforementioned wilson v. williams case found that habeas jurisdiction was – at the very least – cognizable, despite the petitioners’ likely difficulty in proving “deliberate indifference” under the eighth amendment. there, the court held that “a district court reviewing a claim under § 2241 does not have authority to circumvent the established procedures governing the various forms of release enacted by congress.”168 the primary “form[] of release enacted by congress” that provides the roadblock to habeas corpus relief for aggrieved plaintiff inmates is manifest in former attorney general barr’s directions to the bop. the holding of wilson makes it clear – a court will not invoke habeas corpus jurisdiction during the covid-19 pandemic so long as no legal challenge to the authority of established governmental procedures of release exists.169 the judicial inadmissibility of motions for the writ of habeas corpus on conditions of confinement claims during the covid-19 pandemic is not confined 162. miller, 2021 u.s. dist. lexis 14246, at *4. 163. see id. 164. id. 165. id. 166. id. (quoting price v. quintana, no. 20-246, 2020 u.s. dist. lexis 107395 (e.d. ky. june 19, 2020)). 167. see woods v. beard, no. 20-151, 2021 u.s. dist. lexis 7440 (e.d. ky. jan. 14, 2021). 168. wilson v. williams, 961 f.3d 829, 839 (6th cir. 2020). 169. see id. 2022] habeas corpus and covid-19 269 to just the federal circuits analyzed in this note. to the detriment of plaintiff inmates, courts in the eighth and eleventh circuits continue to rule unfavorably toward those who assert conditions of confinement claims in a habeas petition. for example, the aclu of minnesota filed a lawsuit against the federal correctional institution of waseca, minnesota, in december 2020.170 the minnesota aclu alleged that the prison “failed to take sufficient steps to prevent the spread of the coronavirus and did not provide adequate health care as the virus swept through the facility.”171 at the time the suit was filed, nearly 70% of the prison’s inmates had contracted the virus.172 in pursuit of release into home confinement for the fourteen inmates, the minnesota aclu petitioned for the writ of habeas corpus.173 while the u.s. district court for the district of minnesota precluded plaintiffs from relief, just as miller was unsuccessful in his claims against f.c.i. ashland, the reasoning of the appellate and magistrate judges was more akin to the seventh circuit holdings.174 as such, this march 2021 decision establishes that the eighth circuit falls on the seventh circuit’s side of the split in providing no relief on the plaintiffs’ conditions of confinement grounds.175 the judges affirmed that “a writ of habeas corpus [cannot] be used when inmates are claiming they are incarcerated in unsafe conditions [. . .].”176 independent of any mention of the cares act or its inability to be “sidestepped” by habeas, the judges here established that pandemic-related dangers, even in a facility that saw seven out of every ten inmates contract the virus, are not enough to supersede the circuit’s precedent that plaintiff-inmates cannot petition for habeas on conditions of confinement grounds.177 indeed, the court here affirmed that “[t]he eighth circuit holds that a prisoner may not assert a constitutional claim relating ‘to the conditions of [their] confinement’ in a ‘habeas petition.’”178 the court further highlighted that a writ of habeas corpus is not the proper remedy in the eighth circuit “‘[i]f the prisoner is not challenging the validity of [their] conviction or the length of [their] detention [. . .].’”179 under a similar fact 170. kristine goodrich, aclu lawsuit against waseca prison dismissed, free press (mar. 23, 2021), https://www.mankatofreepress.com/news/local_news/aclu-lawsuit-against-wasecaprison-dismissed/article_6e92290e-8c21-11eb-a691-f75dbd38dd34.html [https://perma.cc/jj8rdvhf]. 171. id. 172. id. 173. id. 174. id.; see miller v. beard, no. 21-11, 2021 u.s. dist. lexis 14246 (e.d. ky. jan. 26, 2021). 175. see goodrich, supra note 170; see also savage v. warden of fci pekin, no. 20-cv-1181, 2020 wl 4060768, at *2 (c.d. ill. july 20, 2020) (citing waletzki v. keohane, 13 f.3d 1079, 1080 (7th cir. 1994)). 176. goodrich, supra note 170. 177. see id.; see also, e.g., miller, 2021 u.s. dist. lexis 14246. 178. malcom v. starr, no. 20-2503, 2021 u.s. dist. lexis 45387, at *6-7 (d. minn. mar. 11, 2021) (quoting spencer v. haynes, 774 f.3d 467, 470 (8th cir. 2014)). 179. id. at *7. (quoting kruger v. erickson, 77 f.3d 1071, 1073 (8th cir. 1996)). 270 indiana health law review [vol. 19:249 pattern from the southern district of alabama in royster v. oliver, the eleventh circuit has followed suit in holding that habeas brings no cognizable means of relief in pandemic-related conditions of confinement cases.180 there, the court firmly held that “the eleventh circuit has ‘concluded that a petition for a writ of habeas corpus is not the appropriate mechanism for contesting a prisoner’s conditions of confinement.’”181 narrowing the scope to covid-based claims, the court concluded that “‘[a]ccordingly, courts in this circuit [. . .] have concluded that they lack habeas jurisdiction over claims related to the risk posed by covid19.’”182 in the context of the split between the sixth and seventh circuits, this conclusion regarding the lateral inadmissibility of habeas corpus in covid-based claims is unexpected. prior to the pandemic, the sixth circuit championed the admittance of habeas corpus jurisdiction when conditions of the location of confinement proved adverse to the point of calling the legality of the detention into question.183 now, plaintiff inmates who find themselves not covered by the cares act are without remedy due to the blockade of former attorney general barr’s direction to the bop and subsequent criteria for home release. “deliberate indifference” on the part of prison staff in their protection of prisoners from viral threats is hard for plaintiff inmates to prove.184 this “deliberate indifference” standard is tough in that it requires proof of reckless disregard for a known threat.185 worse for these plaintiff inmates, habeas corpus cannot crack the authority of a congressionally-ratified plan for release like the cares act.186 the covid-19 pandemic compelled congress to enact and the former attorney general to guide the enforcement of a plan of action.187 the plan’s implementation dulled the strength of habeas corpus as a result.188 v. where do we go from here? while courts have not yet granted petitions for the writ of habeas corpus as a remedy for inmates not covered by the cares act, legal practitioners can learn from courts’ treatment of habeas claims and from the intersection between the pandemic and prison law, in general. 180. royster v. oliver, no. 21-00102-cg-b, 2021 u.s. dist. lexis 49696, at *9 (s.d. ala. mar. 15, 2021). 181. id. (quoting a.s.m. v. donahue, no. 20-cv-62, 2020 u.s. dist. lexis 65226, at *3-4 (m.d. ga. apr. 10, 2020)). 182. id. (quoting s.s. v. stewart det. ctr., no. 20-cv-59-cdl, 2020 u.s. dist. lexis 243494, at *5 (m.d. ga. oct. 15, 2020)). 183. see, e.g., adams v. bradshaw, 644 f.3d 481 (6th cir. 2011). 184. see farmer v. brennan, 511 u.s. 825 (1994). 185. see id. 186. see miller v. beard, no. 21-11, 2021 u.s. dist. lexis 14246, at *4 (e.d. ky. jan. 26, 2021). 187. memorandum from att’y gen. william p. barr, supra note 20. 188. see generally miller, 2021 u.s. dist. lexis 14246, at *4. 2022] habeas corpus and covid-19 271 a question arising from the pandemic is how courts treat the “deliberate indifference” standard of eighth amendment conditions of confinement claims.189 while no federal prisoner has successfully paired a habeas corpus petition with proof of “deliberate indifference” by prison staff to the threats of the virus, the amount of prisoners who have complained about prisons doing an inadequate job of protecting against the virus is voluminous.190 the context of the pandemic compels courts to draw a line in the sand; a global viral threat that results in nearly half of the federal prison population contracting a virus should per se fit the definition of “deliberate indifference” in spaces where protocol is not followed. it follows, too, that making prison staff strictly liable for the positive tests of their inmates may not give sufficient deference to the many institutions that follow protocol as best they can and still report positive cases. secondarily, had former attorney general barr’s direction to the bop director and subsequent criteria for release not included the relatively untested pattern electronic algorithm system, it is likely that fewer prisoners will be or would have been precluded from attaining home release.191 the advent of covid-19, too, should allow the legal community the chance to further discuss the problems associated with prison overcrowding and the disparate impact of systems of detention and release on bipoc individuals. the greater conversation regarding inmate advocacy in a viral pandemic has already begun. to combat this disparate impact of viral transmissibility on incarceration settings, health equity task force member homer venters proposes a system of independent audits.192 this auditing, according to venters, “involves creating an official role for the cdc [. . .] in measuring how well carceral settings are doing in these complex [mitigation] tasks, not leaving the assessment of adequacy up to [prisons] to report.”193 further, venters urges systems of auditing to “include measuring whether and how facilities are implementing cdc guidelines and assessing whether deaths from covid-19 related illnesses reflect systemic difficulties in facility responses.”194 even after vaccination mitigates the threat of the novel coronavirus to the degree that americans can resume their lives as normal, legal issues surrounding a prisoner’s ability to appeal their sentence on the grounds of the adverse nature of its setting will still be relevant. this is especially true in a post-covid-19 society that will likely be more conscious of disease control and sensitive to the conditions of those who may pose a greater risk of bodily ailment or death when exposed to a transmittable virus. although the eighth amendment theoretically stands to protect those subjected to the american prison system, individuals put into federally funded and administered custody should not have to be subjected to conditions deleterious to their health and ability to rehabilitate, appeal, or 189. see farmer, 511 u.s. at 825. 190. see miller, 2021 u.s. dist. lexis 14246, at *4. 191. memorandum from att’y gen. william p. barr, supra note 20; hager, supra note 84. 192. harrison, supra note 18. 193. id. 194. id. 272 indiana health law review [vol. 19:249 otherwise operate as a member of society. sans covid-19, the sixth circuit recognizes the strength of habeas corpus to supersede the barriers constructed by legal precedent against plaintiff inmates seeking release when the adverse conditions of confinement go beyond that which should be tolerable under american jurisprudence.195 the same can be said for the second circuit, which has gone further in allowing the pandemic to effectively modify what qualifies as an “extraordinary circumstance”196 that triggers habeas in bail controversies. all jurisdictions should follow suit by recognizing the threats of the covid-19 virus, its morbid dangers to elderly and at-risk individuals, and the speed of its transmissibility as part of a larger “extraordinary circumstance.”197 in hypothesizing the post-pandemic state of improving health in detention settings, homer venters urges that society “ [. . .] need[s] to be honest about the health risks of incarceration. going to jail, prison, and immigration detention brings health risks to people, and the thousands of covid-19 deaths among detained people provide a devastating example of this truth.”198 while venters hopes to “leverage the involvement of public health agencies in covid-19 behind bars” to create substantive change, responsibility falls, too, on the judiciary in providing equitable outcomes for aggrieved plaintiff inmates not covered by the cares act.199 the strength of the federal legislature and the former executive administration in ratifying the cares act provided a blockade that the judiciary has failed to overcome.200 during the covid-19 pandemic, not one plaintiff inmate has effectuated an eighth amendment conditions of confinement claim with a petition for the writ of habeas corpus.201 what courts ignore, or at the very least what the cares act precludes courts from recognizing, is that both the second and sixth circuits different from the seventh, eighth, and eleventh circuits recognize petitions for the writ of habeas corpus in effectuating a conditions of confinement claim.202 in the sixth circuit, the holding of adams v. bradshaw and the court’s recognition of habeas in 195. see e.g., adams v. bradshaw, 644 f.3d 481 (6th cir. 2011). 196. mapp v. reno, 241 f.3d 221, 226 (2d cir. 2001). the second circuit affords bail “in unusual cases, or when extraordinary or exceptional circumstances exist which make the grant of bail necessary to make the habeas remedy effective.” 197. id. 198. harrison, supra note 18. 199. id. 200. see price v. quintana, no. 20-246, 2020 u.s. dist. lexis 107395 (e.d. ky. june 19, 2020). 201. see, e.g., miller v. beard, no. 21-11, 2021 u.s. dist. lexis 14246, at *4 (e.d. ky. jan. 26, 2021). 202. see savage v. warden of fci pekin, no. 20-cv-1181, 2020 wl 4060768 (c.d. ill. july 20, 2020) (holding that the sixth circuit has recognized that habeas jurisdiction is able to cover claims involving conditions of confinement that rise to an extremely adverse level); see also mapp v. reno, 241 f.3d 221, 226 (2d cir. 2001) (explaining that the second circuit affords bail “in unusual cases, or when extraordinary or exceptional circumstances exist which make the grant of bail necessary to make the habeas remedy effective”). 2022] habeas corpus and covid-19 273 wilson v. williams stand analogous to the efforts of those seeking habeas petitions since the beginning of the pandemic.203 in the second, while plaintiffs have found success during the pandemic in petitioning for the writ in obtaining bail instead of relocating their sentences, the fact that cases martinez-brooks v. easter, basank v. decker, and coronel v. decker produced holdings favorable to plaintiffs raises a legitimate question as to their authority in conditions of confinement claims from incarcerated individuals.204 vi. conclusion focusing on the circuit split which provided the occasion for this inquiry, a more liberal interpretation of habeas corpus admissibility based in eighth amendment conditions of confinement claims – where the conditions would have to be proven as challenging the fact of confinement – is the more equitable path during the covid-19 crisis. the worldwide viral pandemic allows for a context through which legal practitioners can analyze the strength of habeas corpus. until authorities publish further information on the matter, legal advocates for habeas corpus jurisdiction cannot purport to say that any of the 200-plus lives lost in federal prisons could have been avoided with the admittance of habeas corpus jurisdiction.205 we fail to know how many of these deaths involved individuals with cognizable risk factors. a discussion regarding the mere potential for these individuals to have obtained representation in the first place beyond the scope of 203. see adams v. bradshaw, 644 f.3d 481, 483 (6th cir. 2011) (holding an ohio death-row inmate challenging the state’s method of execution, which involved lethal injection, by arguing that it was a violation of his eighth amendment rights could successfully petition for the writ of habeas corpus); see also wilson v. williams, 961 f.3d 829 (6th cir. 2020) (holding habeas corpus jurisdiction would have, in fact, existed for the claims made by the plaintiff class had congress not ratified the cares act). 204. see martinez-brooks v. easter, no. 20-cv-00569, 2020 u.s. dist. lexis 94038, at *4-5 (d. conn. may 29, 2020) (holding a petition for the writ of habeas corpus for bail was cognizable where the inmates made a preliminary showing that officials at the institution made only limited use of the home confinement authority vested in them by barr’s memorandum, and that the failure of administration to “downsize immediately the incarcerated population and [. . .] to undertake aggressively the detection, prevention, and treatment measures that public health and medical experts have recommended, including effective social distancing” amount to deliberate indifference to a substantial risk of serious harm to inmates in violation of the eighth amendment); basank v. decker, no. 20 civ. 2518, 2020 u.s. dist. lexis 72178, at *35 (s.d. n.y. apr. 23, 2020) (quoting mapp, 241 f.3d at 226) (holding releasing the petitioners from confinement in this case was necessary to “make the habeas remedy effective” in the circumstance where, if the high-risk petitioners were to remain detained, “they would face a significant risk that they would contract covid-19, the very outcome they seek to avoid”); coronel v. decker, 449 f. supp. 3d 274 (finding a petition for habeas corpus cognizable where “there is a likelihood that petitioners are being subjected to unconstitutional conditions of confinement, and that the risks posed by covid19 are imminent”). 205. covid-19 coronavirus, supra note 9. 274 indiana health law review [vol. 19:249 this note. further discussion regarding the threat of prison overcrowding and, notably, the prison litigation reform act (“plra”) is also better analyzed in a note that is not predicated on a habeas theme.206 however, the pandemic should serve as an example for legal practitioners; perhaps it is important to advocate for the ability of our most fundamental american legal doctrines to gain a level of usability in modern contexts. the viral pandemic will end, but that end has not yet occurred. an ancient legal doctrine like habeas corpus should be construed as to provide relief where the legislature cannot. if greater health and prison law is to reflect pure equity, the legal community must take and recognize the power that their own jurisdictions may give to the writ of habeas corpus. 206. see 18 u.s.c. § 3626(a)(3). the plra requires a special three-judge panel to be requested and convened to decide whether prisoners should be released from prison based on illegal conditions of confinement caused by overcrowding, but the plra also requires there be evidence of a prior court order with less intrusive relief that failed to remedy the deprivation of the federal right sought to be remedied after the prison defendants had a reasonable amount of time to comply. malcom v. starr, no. 20-2503, 2021 u.s. dist. lexis 45387, at *5 (d. minn. mar. 11, 2021). although the act is a vehicle for plaintiff inmates bringing eighth amendment conditions of confinement claims, because this process is wholly different from and does not pertain to a petition for the writ of habeas corpus, an analysis of the plra and covid-era controversies does not appear in this note. indiana health law review volume xx 2023 number 2 articles insider trading in the clinical trial setting allan horwich* and crista m. brawley** abstract the securities and exchange commission’s enforcement agenda regularly includes charges of trading based on material nonpublic information about a clinical drug trial conducted to obtain fda approval to market a new drug. almost half of the recent cases have been accompanied by a criminal indictment. in an academic setting, researchers and those who advise them, unlike employees of public companies, are not generally given training about the risks of securities trading. recent developments in the law might be applied in connection with clinical trial information in ways that would not have been foreseen until recently. it is time for a comprehensive analysis of how the law of insider trading may be applied to the important endeavor of clinical drug trials. clinical trials should not be sullied by conflicts created by unlawful trading. this article begins with the basic principles of insider trading, followed by a summary of how clinical trials are conducted and regulated. it then turns to the ways in which nonpublic information material to the stock price of the sponsor of the trial might be used to trade or tip. the analysis that follows identifies a number of situations where use or disclosure of material nonpublic information about a trial could be unlawful. employees of sponsors of the trial, clinical investigators, and even the subjects * professor of practice, northwestern pritzker school of law (a-horwich@law. northwestern.edu), and partner, arentfox schiff (allan.horwich@afslaw.com), jd. ** associate vice president for research, northwestern university (crista.brawley@ northwestern.edu), ph.d., ccrp. the views expressed in this article should not be attributed to arentfox schiff or to any of its clients. no statements of what northwestern university’s rules, policies, or forms require should be understood as a statement on behalf of northwestern university or any of its affiliates. the authors express their appreciation to northwestern colleagues yoon-ho alex lee and cary martin shelby for useful comments; to qian (eva) gao and juneyoung (june) choi, northwestern pritzker school of law, jd 2023 (candidates), for invaluable research; and to jack hitt and samantha kessler of arentfox schiff for shouldering the burden of compliance with the bluebook. allan horwich offers special thanks to mark j. ratain for prompting analysis of the issues analyzed here. any errors are those of the authors. this article speaks as of may 1, 2023, unless otherwise noted. 200 indiana health law review [vol. 20:199 participating in a trial could run afoul of the prohibition on insider trading, such as when information has been used in breach of a confidentiality agreement or exchanged between an investigator and a trial participant, exchanged among trial participants, gleaned from attending medical conferences, and obtained in other settings specific to this industry. presenting the full potential reach of the law facilitates taking steps to avoid violating the law. the analysis demonstrates that anyone involved in a clinical drug trial must be attuned to the risks of misusing material nonpublic information, including in scenarios not yet pursued by the sec. by understanding the potential reach of the law, those involved in or who learn information about a specific trial can take steps to avoid or minimize the risk of liability. the article concludes with recommendations to achieve this end. the article thus presents a complete case study of an industry-specific application of insider trading law, with recommendations that can be applied to other industries. table of contents i. introduction ii. the fundamentals of the law of insider trading under rule 108-53 a. the classical theory of insider trading b. the misappropriation theory of insider trading 1. relationship of trust and confidence a. caselaw b. rule 10b5-2 c. the deception theory d. culpability e. tipping f. proposed legislative changes to insider trading law iii. material nonpublic information a. nonpublic information b. material information iv. an overview of the clinical trail framework a. the regulatory process b. financial interests and conflicts of interest v. insider trading in the clinical trial setting – cases where the law has been applied vi. insider trading in the clinical trial setting – applying recognized principles a. participant enrollment phase b. active trial phase 1. potential securities law liability arising from trading based on or disclosing mnpi during the trial and other concerns a. risk to the trial itself from a securities law violation or other misconduct b. potential rule 10b-5 liability for (a) classical trading, (b) misappropriating to trade, or (c) tipping 2023] insider trading in the clinical trial setting 201 c. risks of insider trading violation by government personnel d. other risks of violating rule 10b-5 not involving insider trading c. what information about a clinical trial is material? d. when does information about a clinical trial become public? e. summary of types of insider trading claims that might arise in clinical trial setting vii. recommendations for prophylactic action viii. conclusion appendix i. introduction a substantial body of federal common law delineates when it is unlawful to trade in securities based on material nonpublic information (“mnpi”) relating to the company that issued the securities.1 this law springs primarily from securities and exchange commission (“sec” or “commission”) rule 10b-5,2 adopted pursuant to authority granted by section 10(b) of the securities exchange act of 1934 (“exchange act”).3 rule 10b-5 is the basis for a substantial proportion of all sec civil and doj criminal cases for a violation of the securities laws, including insider trading.4 no drug can be marketed in interstate commerce without the prior approval of the federal food and drug administration (“fda”),5 a division of the 1. see donald c. langevoort, insider trading: reg., enf’t & prevention § 1:10 (2022) (the two principal theories of insider trading under rule 10b-5 “are largely federal common law concepts accepted judicially as a way of interpreting the very general language of rule 10b-5”). see infra part ii.g (identifying proposed legislative changes). most references in this article to “insider trading” mean “unlawful insider trading.” there is no detailed discussion of state securities laws or state case law that prohibits or provides a remedy for insider trading. see stephen m. bainbridge, insider trading l. & pol’y ch. 2 (2014) (discussing state law of insider trading). most notably, delaware courts recognize a cause of action on behalf of the company to recover insider trading profits reaped by insiders. see brophy v. cities serv. co., 70 a.2d 5 (del. 1949). 2. 17 c.f.r. § 240.10b-5. it shall be unlawful for any person, directly or indirectly, by the use of any means or instrumentality of interstate commerce, or of the mails or of any facility of any national securities exchange, (a) to employ any device, scheme, or artifice to defraud, (b) to make any untrue statement of a material fact or to omit to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading, or (c) to engage in any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person, in connection with the purchase or sale of any security. 3. 15 u.s.c. § 78j(b). 4. see, e.g., donna m. nagy et al., securities litigation, enforcement, and compliance: cases and materials 23 (5th ed. 2023) (“rule 10b-5 is the leading anti-fraud weapon in the federal securities laws.”). 5. 21 u.s.c. § 355. 202 indiana health law review [vol. 20:199 department of health and human services (“hhs”),6 after a clinical trial.7 this article evaluates many scenarios where insider trading might occur in the context of a clinical trial. while there have been many sec enforcement actions charging insider trading based on mnpi about clinical trials,8 there has been scant scholarly attention to the insider trading issues peculiar to that highly regulated framework.9 the prevalence of these claims demonstrates that a comprehensive analysis is called for to address conduct that might be unlawful and how to avoid it. this article applies both recognized and developing principles of insider trading to all stages of a clinical trial. parts ii and iii explain the core principles of the law of insider trading. part iv describes the framework for conducting human clinical drug trials to obtain fda approval. parts v and vi address how the law of insider trading, as well as rule 10b-5 more broadly, has been applied and might be applied where there is mnpi regarding a trial. part vii recommends measures to reduce the risk of violating the law for anyone who might be involved in or learn about a clinical trial, including medical doctors, other investigators, and the trial participants, sometimes called “subjects,” in a clinical trial, part viii concludes. ii. the fundamentals of the law of insider trading under rule 10b-5 the sec can pursue civil enforcement charges for insider trading in a federal court or at the sec itself in an administrative proceeding.10 only the doj can 6. see food & drug administration, hhs.gov, https://www.hhs.gov/ohrp/regulations-andpolicy/regulations/fda/index.html [https://perma.cc/7hph-cbxp] (last updated mar. 18, 2016) (“the food and drug administration (fda) is an hhs agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.”). 7. 45 c.f.r. § 46.102(b). the fda defines “clinical trial” to mean a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” fda requirements are described in more detail in part iv. 8. see, e.g., infra text accompanying notes 22-25 and 115-21 (discussing cases). 9. see, e.g., allan horwich, the clinical trial research participant as an inside trader: legal and policy analysis, 39 j. health l. 77 (2006); aaron s. kesselheim et al., physicians and insider trading, 175 jama internal med. 1955 (2015); james r. ferguson, biomedical research and insider trading, 337 new eng. j. med. 631 (1997); robert a. prentice, clinical trial results, physicians, and insider trading, 20 j. legal med. 195 (1999); paul r. helft et al., inside information: financial conflicts for research subjects in early phase clinical trials, 96 j. nat’l cancer inst. 656 (2004). 10. see exchange act sections 21, 21a, 21b(a)(2), and 21c, 15 u.s.c. §§ 78u, 78u-1, 78u2(b)(2), 78u-3. there is limited discussion here of the sanctions that are available. see langevoort, supra note 1, ch. 8 (describing civil and criminal remedies for unlawful insider trading). throughout this article, however, there are descriptions of the sanctions imposed or agreed to in specific cases, to demonstrate the potential severity of the consequences of engaging in insider trading. someone who has engaged in insider trading may also be sued by an investor for 2023] insider trading in the clinical trial setting 203 prosecute criminal charges; the sec can, however, suggest that the doj do so.11 what follows provides a primer of the law of insider trading sufficient to understand its potential application in the clinical trial setting. a. the classical theory of insider trading under the classical, or traditional, theory of insider trading, rule 10b-5 is “violated when a corporate insider trades in the securities of his corporation on the basis of material, nonpublic information” about the company or its securities.12 this violates rule 10b-5 because “a relationship of trust and confidence” exists “between the shareholders of a corporation and those insiders who have obtained confidential information by reason of their position with that corporation,” which gives rise to a duty to make public disclosure before trading or to abstain from trading.13 this is the “disclose or abstain” rule.14 under the classical theory, an “insider” subject to this duty includes not only a member of the board of directors and a senior officer of the company but also any employee of the company that issued the securities in which the “insider” traded.15 this also includes a “temporary insider”: under certain circumstances, such as where corporate information is revealed legitimately to an underwriter, accountant, lawyer, or consultant working for the corporation, these outsiders may become fiduciaries of the shareholders. the basis for recognizing this fiduciary duty is not simply that such persons acquired nonpublic corporate information, but rather that they have entered into a special confidential relationship in the conduct of the business of the enterprise and are given access to information solely for corporate purposes.16 for example, the lead investigator of a clinical trial who works for an academic institution may be a temporary insider of the trial sponsor.17 b. the misappropriation theory of insider trading under the misappropriation theory of insider trading, a person violates rule damages, relying on rule 10b-5 or exchange act section 20a, 15 u.s.c. § 78t-1 (providing for private cause of action). see langevoort, supra note 1, ch. 9 (describing private claims for insider trading). 11. exchange act section 21(d)(1), 15 u.s.c. § 78u(d)(1) (last sentence). 12. united states v. o’hagan, 521 u.s. 642, 651-52 (summarizing the import of chiarella v. united states, 445 u.s. 222, 228 (1980)). 13. o’hagan, 521 u.s. at 652. 14. see bainbridge, supra note 1, ch. 6. 15. see langevoort, supra note 1, § 3:5 (“employees of the issuer are agents/servants of the corporation and are held to duties of loyalty that include the obligation not to profit from confidential information given to them in the course of their employment.”). 16. dirks v. sec, 463 u.s. 646, 655 n.14 (1983). 17. see infra text accompanying notes 22-25 (discussing case). 204 indiana health law review [vol. 20:199 10b-5 when he takes confidential information for securities trading purposes, in breach of a duty owed to the source of the information, because a fiduciary’s undisclosed, self-serving use of a principal’s information to purchase or sell securities, in breach of a duty of loyalty and confidentiality, defrauds the principal of the exclusive use of that information.18 trading before first making disclosure to the source of the information of the intent to trade based on mnpi violates rule 10b-5; there is no requirement that the trader first obtain permission from the source to trade or, unlike the classical theory, to make public disclosure before trading.19 1. relationship of trust and confidence a. caselaw initially it fell to the courts to determine what constituted a “relationship of trust and confidence.”20 a relationship of trust and confidence might exist between employer and employee, doctor and patient, attorney and client, and among family members, as well as where there is a confidentiality agreement, requiring the application of state law.21 two insider trading criminal convictions demonstrate how the misappropriation theory has been applied in a medical setting. trading in breach of confidentiality agreements was the basis for the conviction of a medical doctor who held a senior role at one clinical trial site.22 he had been required “to maintain in ‘strict confidence’ all the information with which he was provided to enable him to perform as principal investigator.”23 when he received confidential 18. o’hagan, 521 u.s. at 652-53 (recognizing and applying misappropriation theory, resolving circuit split). 19. id. see also united states v. falcone, 257 f.3d 226, 232 n.3 (2d cir. 2001) (stating that notwithstanding the damaging effect of inequality of information vis-à-vis the public, disclosure to the information source can eliminate liability under the misappropriation theory). 20. see bainbridge, supra note 1, at 81-85 (discussing pre-o’hagan developments and the ensuing circuit split). 21. william k. s. wang & marc i. steinberg, insider trading § 5.4.3 (3d ed. 2010) (citing and discussing cases); langevoort, supra note 1, §§ 6:6-6:7 (including extended discussion of major cases); bainbridge, supra note 1, ch. 8c (discussing covered relationships). 22. united states v. kosinski, 976 f.3d 135 (2d cir. 2020) (affirming insider trading convictions). kosinski was sentenced to six months imprisonment, among other penalties. sec v. kosinski, litig. release no. 25077, 2021 wl 1580442 (apr. 21, 2021). in another recent case where a principal investigator was indicted for trading based on material clinical trial results, the defendant pleaded guilty and was sentenced to a year of supervised release, with the first five months under home confinement. ivan moreno, ex-uchicago professor avoids prison for insider trading, law360 (aug. 3, 2022, 7:52 pm), https://www.law360.com/capitalmarkets/articles/ 1518062/ex-uchicago-professor-avoids-prison-for-insider-trading?about=capitalmarkets [https://perma.cc/9jhy-n8rn]. 23. kosinski, 976 f.3d at 140. 2023] insider trading in the clinical trial setting 205 bad news about the trial, he sold the stock he owned in the trial sponsor. as more bad news emerged internally, he bought put options on the stock, presumably concluding that when the news became public the price of the stock would drop, which it did, with a corresponding increase in the value of the puts.24 the defendant was held to have misappropriated the information he received by trading in breach of the confidentiality agreements and to have violated rule 10b5 by trading based on mnpi he received as a temporary insider of the sponsor.25 in an earlier case, united states v. willis, a patient allegedly confided to her psychiatrist that her husband was seeking to become the ceo of a major financial institution.26 after dr. willis learned this information in the therapy session, he purchased stock in that company. when the husband’s appointment as ceo was announced and the stock price rose, willis sold at a profit. in denying a motion to dismiss the indictment, the court stated that “[a] treating psychiatrist’s relationship to his patient is a traditional inherently fiduciary relationship,”27 and so applied the misappropriation theory to willis’s breach of duty to the patient. b. rule 10b5-2 the sec sought to bring some clarity to the concept of the relationship of trust and confidence in misappropriation cases by adopting rule 10b5-2(b).28 it provides in part that a “duty of trust or confidence” exists: (1) whenever a person agrees to maintain information in confidence; (2) whenever the person communicating the material nonpublic information and the person to whom it is communicated have a history, pattern, or practice of sharing confidences, such that the recipient of the information knows or reasonably should know that the person communicating the material nonpublic information expects that the recipient will maintain its confidentiality[.]29 24. id. at 139. the sponsor terminated the clinical trial because of adverse reactions to the drug, including one death. 25. id. at 144-46 (applying temporary insider concept in misappropriation case). 26. united states v. willis, 737 f. supp. 269, 271 (s.d.n.y. 1990) (initial opinion denying motion to dismiss indictment); see also united states v. willis, 778 f. supp. 205 (s.d.n.y. 1991) (denying motion to dismiss indictment a second time, after consideration of intervening second circuit insider trading case). 27. willis, 778 f. supp. at 209. willis pleaded guilty and was sentenced to a five-year term of probation and other penalties. inside-trading psychiatrist is spared jail: securities: a new york man who obtained stock information from a patient--the wife of a top executive--gets probation and a $150,000 fine, la times archives (jan. 8, 1992, 12:00 am), https://www.l atimes.com/archives/la-xpm-1992-01-08-fi-1619-story.html [https://perma.cc/57bx-6jqz]. 28. whether this rule is valid is beyond the scope of this article. see united states v. mckee, 763 f.3d 304, 316 (3d cir. 2014) (upholding rule 10b5-2 but also stating “we are not without reservations concerning the breadth of misappropriation under rule 10b5-2(b)(2)”). 29. 17 c.f.r. § 240.10b5-2(b). 206 indiana health law review [vol. 20:199 when an insider has received mnpi from the corporation in confidence and then uses it to trade, both the classical theory and the misappropriation theory apply.30 c. the deception theory a third category of a violation of rule 10b-5 violations involves obtaining mnpi by affirmative deception and subsequent trading based on that information.31 the seminal case involved “deceiving” a computer system, apparently using hacked credentials of an authorized person so that the system was deceived into allowing the trader access to nonpublic earnings information he used to trade.32 d. culpability there is a state of mind, or culpability, requirement in every case under rule 10b-5. early in its rule 10b-5 jurisprudence, the supreme court held that an essential element of any rule 10b-5 claim is that the defendant acted with scienter–an “intent to deceive, manipulate or defraud.”33 negligence does not suffice.34 this applies to rule 10b-5 enforcement actions.35 in a civil insider trading case, for example, the sec must prove that the defendant knew, or was reckless in disregarding, that the mnpi was material and nonpublic.36 in criminal 30. see united states v. kosinski, 976 f.3d 135, 145 (2d cir. 2020). “temporary insiders are . . . forbidden from trading under both the classical and misappropriation theories without the requisite disclosure. indeed, the only meaningful difference between the two theories is the victim of the fraud. where, as here, a trader owes a duty to both the shareholders with whom he trades and the source of the confidential information on which he trades, he must make disclosure to both.” in complaints for insider trading, the sec seldom specifies which theory it is relying on. 31. sec v. dorozhko, 574 f.3d 42, 49-51 (2d cir. 2009) (obtaining mnpi through deceptive means and then trading based on that information may violate rule 10b-5). 32. see sec v. dorozhko, sec litig. release no. 21465, 2010 wl 1213430 (mar. 29, 2010) (summarizing the court’s grant of summary judgment to sec on remand of dorozhko). 33. ernst v. hochfelder, 425 u.s. 185, 193, n.12 (1976) (footnote omitted). 34. id. at 203, 215. while the court observed that “[i]n certain areas of the law recklessness is considered to be a form of intentional conduct,” the court did not determine whether recklessness was sufficient. id. at 193 n.12. the court has not addressed the question since hochfelder; all courts of appeals that have addressed the issue have found scienter to include reckless conduct, variously defined. tellabs, inc. v. makor issues & rights, ltd., 551 u.s. 308, 319 n.3 (2007). 35. aaron v. sec, 446 u.s. 680, 691 (1980) (“the rationale of hochfelder ineluctably leads to the conclusion that scienter is an element of a violation of § 10(b) and rule 10b-5, regardless of the identity of the plaintiff or the nature of the relief sought”). see dirks v. s.e.c., 463 u.s. 646, 663 n.23 (1983) (discussing application of scienter requirement in insider trading case); see generally langevoort, supra note 1, §§ 3:13, 6:12 (discussing scienter under classical and misappropriation theories). 36. see langevoort, supra note 1, § 5.5 (“scienter is established if the defendant knew that the information was material and nonpublic, or recklessly disregarded facts that would indicate that 2023] insider trading in the clinical trial setting 207 cases, section 32 of the exchange act requires that the government prove willful misconduct,37 which means “[w]illful intentional, purposeful, and voluntary, as distinguished from accidental or negligent.”38 e. tipping where the person who knows mnpi cannot lawfully trade, it may be unlawful for him to disclose that mnpi to another: tipping. in the supreme court’s first tipping case, a company insider provided mnpi to dirks, a stockbroker, hoping dirks would bring public attention to what the insider believed, accurately, was a massive fraud at the company.39 while dirks was trying to bring the fraud to light, he also disclosed the mnpi to some of his customers. they sold their stock in the company before the truth was revealed, and the stock price plummeted.40 the sec brought an administrative proceeding against dirks as a broker, alleging that he violated the exchange act when he provided mnpi to his customers.41 the supreme court held that insiders may not disclose mnpi to an outsider, a “tippee,” for the “improper purpose of exploiting the information for their personal gain.”42 “[t]he test is whether the insider personally will benefit, directly or indirectly, from his disclosure. absent some personal gain, there has been no breach of duty to stockholders. and absent a breach by the insider, there is no derivative breach” by the tippee who trades.43 the tippee is liable “when the insider has breached his fiduciary duty to the shareholders by disclosing the information to the tippee and the tippee knows or should know that there has been a breach.”44 in assessing whether a disclosure breached a duty, the fact-finder should look to “objective criteria, i.e., whether the insider receives a direct or indirect personal the information in his possession was material and nonpublic”) (footnote omitted). in the tipping context (discussed infra part ii.e), see sec v. obus, 693 f.3d 276, 286 (2d cir. 2012) (finding that “the tipper must know that the information that is the subject of the tip is non-public and is material for securities trading purposes or act with reckless disregard of the nature of the information”). 37. 15 u.s.c. § 78ff (providing criminal sanctions of up to twenty years in prison, a fine of five-million dollars (or up to twenty-five-million dollars in the case of a defendant other than a natural person) or both for “willfully violat[ing]” an sec rule). 38. see, e.g., united states v. o’hagan, 139 f.3d 641, 647 (8th cir. 1998) (ruling that “willfully” requires only the intentional doing of the wrongful acts, there is no requirement that the defendant knew of the rule or regulation that was violated). 39. dirks, 463 u.s. at 646. 40. id. at 649-50. 41. in re dirks, securities exchange act release no. 17480, 1981 wl 36329 (jan. 22, 1981) (finding that dirks aided and abetted his customers’ violations of rule 10b-5), pet. for rev. dismissed, 681 f.2d 824 (d.c. cir. 1982), rev’d 463 u.s. 646 (1983). 42. dirks, 463 u.s. at 660 (footnotes omitted). 43. id. at 662 (footnote omitted). 44. id. at 660 (footnote omitted). 208 indiana health law review [vol. 20:199 benefit from the disclosure, such as a pecuniary gain or a reputational benefit that will translate into future earnings.”45 for example, “there may be a relationship between the insider and the recipient that suggests a quid pro quo from the latter, or an intention to benefit the particular recipient.”46 the court exonerated dirks because, among other factors, the persons who gave dirks the information did so for a proper purpose, to reveal the fraud.47 one element of tipper liability is that the tipper must have expected or reasonably expected that the tippee would trade based on the mnpi shared by the tipper.48 a tipper may be liable when the tippee is not liable, even though the tippee traded.49 two aspects of tipping liability should be kept in mind when reading the analysis in parts v and vi infra. first, application of the law of tipping in the clinical trial setting may focus on whether the tipper would benefit by tipping, and what the nature of that benefit might be. that is, however, only one element of tipping. though it will not be repeated every time a tipping question is addressed here, the essential elements of (a) whether the tipper breached a duty by tipping, (b) whether the tippee understood that the tipper breached by tipping, and (c) whether the tipper had some expectation that the tippee would trade, must eventually be addressed in order to do a comprehensive analysis. second, misappropriation and tipping are distinctly different paths to liability. if x gave y mnpi so that y can do his job, to fulfill some sort of lawful responsibility, and then y, instead of or in addition to the proper purpose, used that information to trade in the stock, y engaged in misappropriation in violation of rule 10b-5, if y had a relationship of trust and confidence with x. if, however, x provided y, the mnpi with the expectation that y would trade and y did trade, then x has likely disclosed mnpi to y for an improper purpose, and, depending on what y understood about the nature of the disclosure by x to him (e.g., did y recognize that x’s disclosure was in breach of a duty?), y might be an unlawful tippee. 45. id. at 663-64 (citations omitted). 46. id. at 664 (citations omitted). 47. id. at 666-67. 48. in the criminal context, see salman v. united states, 137 s. ct. 420, 428 (2016) (ruling that tipper must be shown to have expected tippee would trade). in the civil enforcement context, see sec v. obus, 693 f.3d 276, 287 (2d cir. 2012) (ruling that test is whether tippee “may reasonably be expected [by the tipper] to use [mnpi] to his advantage,” (quoting elkind v. liggett & myers, inc., 635 f.2d 156, 167 (2d cir. 1980)). in obus, the court stated that in a civil case “there is a valid defense to scienter if the tipper can show that he believed in good faith that the information disclosed to the tippee would not be used for trading purposes.” id. at 287. see langevoort, supra note 1, § 4:10 (discussing various aspects of tippee scienter). 49. see, e.g., sec v. tome, 638 f. supp. 596, 617 (s.d.n.y. 1986) (“even if there has been a breach by the tipper of his fiduciary or similar duty of trust and confidence, the tippee only commits fraud within the meaning of section 10(b) and rule 10b-5 if the tippee trades on that inside information when he ‘knows or should know’ that the inside information was conveyed to him in breach of the tipper’s duty.”). 2023] insider trading in the clinical trial setting 209 f. proposed legislative changes to insider trading law congress has made some efforts to define insider trading in legislation.50 most recently, on may 18, 2021, the house of representatives passed h.r. 2655, the insider trading prohibition act.51 no action was taken in the senate.52 the operative provision would have predicated liability on the misuse of information “obtained wrongfully.” the bill defined that to include information obtained by: (a) theft, bribery, misrepresentation, or espionage (through electronic or other means); (b) a violation of any federal law protecting computer data or the intellectual property or privacy of computer users; (c) conversion, misappropriation, or other unauthorized and deceptive taking of such information; or (d) a breach of any fiduciary duty, a breach of a confidentiality agreement, a breach of contract, a breach of any code of conduct or ethics policy, or a breach of any other personal or other relationship of trust and confidence for a direct or indirect personal benefit (including pecuniary gain, reputational benefit, or a gift of confidential information to a trading relative or friend).53 iii. material nonpublic information the prohibitions discussed here apply only to information that is both material and not public. this part explains these concepts in general terms; they are expanded upon and applied in parts vi.c and vi.d. the analysis of these issues is informed not only by insider trading cases, but also by other litigation under rule 10b-5. every public company is vulnerable to a rule 10b-5 class action claim by investors that its public disclosures, such as press releases and filings with the sec, misled investors.54 pharmaceutical companies are no exception, though they often successfully fend off the claim on a motion to dismiss.55 one commentator reported that in the first six months of 50. langevoort, supra note 1, ch. 13 (including an account of prior efforts to reform the law of insider trading through legislation). 51. insider trading prohibition act, h.r. 2655, 117th cong. (2021), reprinted in 167 cong. rec. h2460 (daily ed. may 18, 2021); langevoort, supra note 1, ch. 13 (including an account of prior efforts to reform the law of insider trading through legislation). 52. h.r. 2655. 53. id. (proposed new section 16a(c)(1) of the exchange act). 54. see arnold s. jacobs, disclosure & remedies under the securities laws § 12:112 (2022) (discussing cases of corporate liability for misleading statements in violation of rule 10b-5). 55. see, e.g., thant v. karyopharm therapeutics inc., 43 f.4th 214 (1st cir. 2022) (affirming dismissal of complaint that alleged that company materially misled investors in statements about a trial for its cancer-fighting drug, finding that plaintiff did not plausibly allege a materially 210 indiana health law review [vol. 20:199 2022, drug companies were the second largest category of business sued in securities class actions.56 they are also vulnerable to sec enforcement actions for misleading investors.57 any ruling in a class action complaint that alleges that a company made deceptive statements about a drug in development is instructive on elements of insider trading by an individual in the pharmaceutical setting. for example, investor-plaintiffs in a rule 10b-5 class action often seek to demonstrate the required element of scienter of the company or of the individual defendants in making materially false statements to the public, by alleging that members of management engaged in insider trading.58 any determination of what is found to be material in a class action will shed light on what information is material generally, and in particular, in a parallel insider trading case. a. nonpublic information if information can be found in an internet search, it is almost certainly not “nonpublic.”59 information can be public even if it is not generally available, however, such as a report by a research analyst provided only to his clients.60 information can also be “public” even if it does not meet the test of what a public company must do when it seeks to achieve public disclosure. for example, in 2000, the sec adopted a regulation that required “public disclosure” of misleading statement or omission with respect to the drug trial disclosures). 56. kevin lacroix, pace of securities suit filings in first half 2022 slightly below last year’s annual level, d&o diary (july 5, 2022), https://www.dandodiary.com/2022/07/articles/ securities-litigation/pace-of-securities-suit-filings-in-first-half-2022-slightly-below-last-yearsannual-level/ [https://perma.cc/n79b-xyal] (referring to companies in sic code 283). 57. see sec v. ferrone, no. 11-c-5223, 2014 wl 5152367 (n.d. ill. oct. 10, 2014) (granting summary judgment to s.e.c. on insider trading claim regarding status of clinical trial). investors filed a class action based on the same nucleus of facts. compl., campbell v. immunosyn corp., no. 09-cv-00197 (s.d. tex. aug. 24, 2009), ecf no. 1. 58. see supra text accompanying notes 31-36. in the pharmaceutical field, see compl. at ¶¶ 3-5, 6, 24, 28, 36, 134-37, in re fibrogen, inc., sec. litig., no. 21-cv-02623 (n.d. cal., oct. 29, 2021), ecf no. 91 (alleging insider trading by executives as supporting allegation of scienter in rule 10b-5 class action complaint regarding public statements regarding alleged falsified phase iii clinical trial results). 59. robert a. prentice, the internet and its challenges for the future of insider trading regulation, 12 harv. j. l. & tech. 263, 282-83 (1999) (stating that availability of information on internet may be “public” for purposes of insider trading law, though the issue is not free from doubt). 60. see, e.g., lea v. tal educ. grp., 837 f. app’x 20, 27-28 (2d cir. 2020) (holding that disclosure of previously nonpublic information and of information not readily accessible by investors that is included in securities firm research report followed by significant loss in company’s stock price was sufficient allegation of public disclosure of prior misleading statements for purposes of a rule 10b-5 issue before the court). 2023] insider trading in the clinical trial setting 211 previously nonpublic information in certain circumstances.61 “[p]ublic disclosure” includes “disseminat[ing] the information through [a] method (or combination of methods) of disclosure that is reasonably designed to provide broad, nonexclusionary distribution of the information to the public.”62 an alternative test recognizes that information is no longer nonpublic “even though there has been no public announcement” where the trading of those who do know the information has caused the information to be “fully impounded into the price of the particular stock. once the information is fully impounded in price, such information can no longer be misused by trading because no further profit can be made.”63 b. material information a fact is material if there is a substantial likelihood that a reasonable investor would consider it important in making an investment decision. an omitted fact is material if there is a substantial likelihood that the disclosure of the omitted fact would have been viewed by the reasonable investor as having significantly altered the “total mix” of information made available.64 “[w]ith respect to contingent or speculative information or events . . . materiality ‘will depend at any given time upon a balancing of both the indicated probability that the event will occur and the anticipated magnitude of the event in light of the totality of the company activity.’”65 this probability/magnitude test could apply in a clinical trial setting, as more information emerges, resulting in more–or less–confidence in the outcome of the trial.66 in a case addressing the materiality of adverse events that might have been caused by a drug already on the market, defendants argued that facts that are not statistically significant cannot be material.67 the supreme court rejected that bright line rule, noting that the “fda . . . does not limit the evidence it considers for purposes of assessing causation and taking regulatory action to statistically significant data[,]” and “[g]iven that medical professionals and regulators act on the basis of evidence of causation that is not statistically significant, it stands to reason that in certain cases reasonable investors would as well.”68 a significant movement in the price of a stock after disclosure of previously 61. sec regulation f.d., 17 c.f.r. § 243 (2011). 62. 17 c.f.r. § 243.101(e) (2011). 63. united states v. libera, 989 f.2d 596, 601 (2d cir. 1993). 64. basic, inc. v. levinson, 485 u.s. 224, 231-32 (1988). 65. id. at 238 (quoting sec v. tex. gulf sulphur co., 401 f.2d 833, 849 (2d cir. 1968) (en banc)). 66. sec v. johnston, 986 f.3d 63, 76-77 (1st cir. 2021) (approving probability/magnitude jury instruction in affirming judgment against defendant for having misled investors in statements relating to clinical trial). see also infra part iii.b. 67. matrixx initiatives, inc. v. siracusano, 563 u.s. 27, 38 (2011). 68. id. at 40, 43 (citations to cases and to the record omitted). 212 indiana health law review [vol. 20:199 undisclosed facts is often evidence that the facts were material.69 disclosure of the results of a drug trial can have a significant effect on the price of the sponsoring company’s stock, especially where the company’s fortunes stand or fall with whether the particular drug is approved by the fda.70 determining whether a fact is material depends on an assessment of all of the facts.71 “[m]ateriality has become one of the most unpredictable and elusive concepts of the federal securities laws.”72 iv. an overview of the clinical trial framework this part describes the requirements for conducting a clinical trial sufficient to understand the application of insider trading law to that endeavor, for all persons involved–from the firm sponsoring the trial to clerical personnel who record trial data.73 because sec enforcement actions for insider trading typically involve transactions in the stock of a public company, the focus in this article is on clinical trials where the outcome of the trial reasonably could affect the value of the stock of a publicly traded company, the sponsor, seeking fda approval to 69. see, e.g., oran v. stafford, 226 f.3d 275, 282 (3d cir. 2000) (holding that in an efficient stock market “the materiality of disclosed information may be measured post hoc by looking to the movement, in the period immediately following disclosure, of the price of the rm’s stock”). but see, united states v. bilzerian, 926 f.2d 1285, 1298 (2d cir. 1991) (ruling that whether a stock price moves after disclosure of the previously undisclosed facts “does not establish the materiality of the statements made”). one study addressed the difficulty of analyzing stock price movements where clinical trials are involved. see adam feuerstein & mark j. ratain, oncology micro-cap stocks: caveat emptor!, 103 j. nat. cancer inst. 1488, 1489 (2011). 70. see, e.g., united states v. kosinski, 976 f.3d 135, 141 (2d cir. 2020) (alleging stock price dropped 58% after announcement of termination of clinical trial); order instituting proceedings, in re sweeney, securities exchange act release no. 95204 (july 7, 2022) (alleging that stock dropped 71% after disclosure of discontinuance of clinical trial); order instituting proceedings at ¶ 6, in re spector, securities exchange act release no. 95163 (june 27, 2022) (alleging, in clinical trial insider trading case, where company “had never generated revenues and depended on products then in development for future revenues” and the drug in question “was its lead product candidate, and the only one publicly identified as having advanced to the clinical trial stage of development,” stock dropped 75% when bad news was disclosed.). id. at ¶ 13. 71. see, e.g., joan macleod heminway, materiality guidance in the context of insider trading: a call for action, 52 am. u. l. rev. 1131, 1138-39 (2003) (“the interpretation and application of the materiality standard are highly fact-dependent and do not always produce predictable or certain planning options or judicial results.”) (footnote omitted). 72. sec v. bausch & lomb inc., 565 f.2d 8, 10 (2d cir. 1977). see also james d. cox et al., securities regulation cases and materials 552 (10th ed. 2021) (making these judgments is an “ulcerating experience”). 73. for a comprehensive description of the clinical trial process from the perspective of the researcher, see deborrah norris, clinical research coordinator handbook 1 (5th ed. 2019). 2023] insider trading in the clinical trial setting 213 market the drug for profit.74 a. the regulatory process all trials seeking fda approval to market a drug must comply with regulations in title 21 of the code of federal regulations.75 a second set of regulations, in part 46 of title 45 of the code of federal regulations (part a of which is referred to as the “common rule”76), may also apply, particularly where federal funding finances the trial.77 the common rule is generally adhered to by a research institution, such as a medical school, in all of its human subjects research.78 as a practical matter, most human clinical trials will comply with both portions of the code of federal regulations; if the regulations differ, the regulations that offer the greater protection to human subjects are followed.79 the 74. id. at 8. 75. see 21 c.f.r. § 50 (2022). 76. 45 c.f.r. § 46 (2018). 77. see 45 c.f.r. §§ 46.101(a), 46.122 (“federal funds administered by a federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.”). funding is often provided by multiple sources such as pharmaceutical companies, academic medical centers, and federal agencies like the national institutes of health, who conducts clinical studies?, clinicaltrials.gov, https://clinicaltrials.gov/ct2/about-studies/learn#whoconducts [https://perma.cc/h963-9qpj] (last visited jan. 19, 2023). government funding may be provided for a clinical trial even where an ultimate financial beneficiary will be a for-profit corporation that began development of the drug. david austin & tamara hayford, cong. budget off., research and development in the pharmaceutical industry (2021) (discussing generally the role of the federal government, private industry, and private investment in the development of new drugs). in most instances, the eventual sponsor is a pharmaceutical company. theresa wizemann et al., inst. med. nat’l acads., breakthrough business models: drug development for rare and neglected diseases and individualized therapies: workshop summary 7 (nat’l acads. press 2009). 78. see generally anushya vijayananthan & ouzrei nawawi, the importance of good clinical practice guidelines and its role in clinical trials, 4 biomedical imaging & intervention j. 1 (2008). in some cases, the research is carried out by a contract research organization (“cro”), a third-party in the business of conducting trials. it, too, must abide by the fda regulations addressed here. see 21 c.f.r. § 312.52(a) (“a sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization”); and § 312.52(b) (“a contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations.”). 79. for example, northwestern university (“northwestern”) expressly requires compliance with fda regulations. nw. univ. irb off., app. a-2 additional requirements for usfdaregulated research 41, investigator manual (2021), http://irb.northwestern.edu/docs/ investigator-manual-general-103.pdf [https://perma.cc/97gr-9all] (generally expressly requiring 214 indiana health law review [vol. 20:199 differences between the two sets of regulations do not affect the insider trading analysis that follows. after researchers test potential new drugs in the lab and in animals, the most promising ones are moved into human clinical trials. clinical trials follow a protocol designed to determine impacts to participants and answer specific research questions. the protocol describes the goal of the trial, principally to determine if a treatment is safe and effective.80 clinical trials are conducted in phases. in phase i trials, a drug or treatment is administered to a small group of humans to learn about its safety and side effects. in phase ii, the new drug is given to a larger group (one to three hundred) to determine its effectiveness and to further study its safety. in phase iii, the new drug or treatment is given to large groups (one to three-thousand) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug to be used safely.81 after each phase of the trial the researchers decide whether the endpoints were met and whether to move to the next phase or to stop testing because the drug was unsafe or not sufficiently effective to be marketed profitably. if the drug trials are successful in phase iii, the next step is to seek fda approval to market the drug, as discussed below. after a new drug has been approved it may become a new standard of care in medical practice.82 a phase iii trial may employ one of three principal types of study design. in a double-blind study, neither the participant nor the researcher knows which treatment each participant is receiving. in a single-blind study, the researcher knows which treatment each participant is receiving, the participant does not. in an open-label study, both the researcher and the participant know which treatment compliance with fda regulations) (hereinafter investigator manual). while there has been no review of the policies or forms of any other major research institution, it is reasonable to assume that northwestern’s policies and forms are, or at least approach, the state of the art, given its very substantial involvement in sponsored research, including clinical trials. see, e.g., our research, nw. feinberg sch. of med., https://www.feinberg.northwestern.edu/about/facts/research/index. html [https://perma.cc/5u8u-j59n] (last visited jan. 19, 2023) (presenting data on northwestern conduct of sponsored research). 80. see, e.g., what are clinical trials and studies?, nih nat’l inst. on aging, https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies [https://perma.cc/q6mk-gkbj] (last updated apr. 9, 2020) (explaining that clinical trials “are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment”). 81. fda’s drug review process: continued, fda, https://www.fda.gov/drugs/informationconsumers-and-patients-drugs/fdas-drug-review-process-continued [https://perma.cc/p4nh-hff6] (last updated aug. 24, 2015). 82. the standard of medical care is “[t]reatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals.” standard of care, nat’l cancer inst., https://www.cancer.gov/publications/dictionaries/cancerterms/def/standard-of-care [https://perma.cc/c4tr-kl8z] (last visited mar. 20, 2023). 2023] insider trading in the clinical trial setting 215 the participant is receiving.83 some participants may receive a placebo, “[a]n inactive substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested.”84 “the placebo effect is a beneficial health outcome resulting from a person’s anticipation that an intervention will help. how a health care provider interacts with a patient also may bring about a positive response that’s independent of any specific treatment.”85 “the ‘gold standard’ for testing interventions in people is the ‘randomized, placebo-controlled’ clinical trial . . . comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance.”86 if phase iii is sufficiently successful, the sponsor can choose to file an application to market the drug.87 the purpose of the new drug application (“nda”) is to demonstrate that a drug is safe and effective for its intended use in the population studied. all studies, data, and analyses must be presented to the fda. if the nda is complete, the review team has approximately six to ten months to analyze the data to determine whether to approve the drug. the team issues a recommendation, and a senior fda official makes a decision. there may be remaining issues to address before final approval. if a developer disagrees with an fda decision, it can appeal. every clinical study is led by a principal investigator (pi), who must be “qualified by training and experience as [an] appropriate expert [] to investigate the drug.”88 the pi is [t]he person(s) in charge of a clinical trial or a scientific research grant. the principal investigator prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant. the principal investigator also analyzes the data and reports the results of the trial or grant 83. blinded study, nat’l cancer inst., https://www.cancer.gov/publications/dictionaries/ cancer-terms/def/blinded-study [https://perma.cc/qr9t-zpxb] (last visited jan. 19, 2023). 84. placebo, nat’l cancer inst., https://www.cancer.gov/publications/dictionaries/cancerterms/def/placebo [https://perma.cc/9jjp-mj8m] (last visited jan. 19, 2023). 85. placebo effect, nat’l ctr. for complementary & integrative health, https:// www.nccih.nih.gov/health/placebo-effect [https://perma.cc/h8w8-y5eg] (last updated jan. 2020). 86. id. as one example, albeit one where plaintiff’s claim did not pass muster, plaintiffs alleged that investors were misled about whether a placebo “was chemically active” which “could have affected the trial’s results and thereby exaggerated ‘the drug’s efficacy’.” in re amarin corp. plc sec. litig., no. 21-2071, 2022 wl 2128560, at *1 (3d cir. june 14, 2022) (affirming grant of motion to dismiss complaint on ground the plaintiffs had not adequately alleged false statements). 87. the basics, nat’l inst. health, https://www.nih.gov/health-information/nih-clinicalresearch-trials-you/basics [https://perma.cc/bw2j-pafv] (last updated oct. 3, 2022); step 4: fda drug review, food & drug admin., https://www.fda.gov/patients/drug-development-process/step4-fda-drug-review [https://perma.cc/8s6a-ynav] (last updated jan. 4, 2018). 88. 21 c.f.r. § 312.53(a) (2023). the pi must submit a completed fda form 1572 to the trial sponsor. this form reflects his qualifications to serve as a pi and attests that he will comply with specific legal requirements. 21 c.f.r. § 312.53(c) (2023); norris, supra note 73, at 11. 216 indiana health law review [vol. 20:199 research.89 “clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.”90 while the pi for the investigation of a drug for human use need not be a medical doctor (“m.d.”),91 if the pi is not a medical doctor, “a qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.”92 as discussed below (parts v and vi), any of these people could engage in unlawful trading. the net is wide. there is a pi at each site, with a single pi responsible for the entire trial.93 significant responsibilities of the pi may be delegated to other qualified members of the team, such as enrollment of individual participants.94 in this article, references to “the pi” generally include the persons designated by the pi to carry out delegated responsibilities. every clinical trial carried out in accordance with the common rule must be overseen by an institutional review board (“irb”), which performs the ethical review of the trial.95 as explained by the fda:96 [a]n irb is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. in accordance with fda regulations, an irb has the authority to approve, require modifications in (to secure approval), or disapprove research. this group review serves an important role in the protection of 89. principal investigator, nat’l cancer inst., https://www.cancer.gov/publications/ dictionaries/cancer-terms/def/principal-investigator. [https://perma.cc/nwa7-7489] (last visited jan. 19, 2023). 90. learn about clinical studies, clinicaltrials.gov, https://clinicaltrials.gov/ct2/aboutstudies/learn#whoconducts [https://perma.cc/t69f-tfge] (last updated mar. 2019); see also principal investigator eligibility for irb protocols, nw. uni., https://irb.northwestern.edu/docs/pieligibility-for-irb-protocols-v.2.pdf [[https://perma.cc/9zme-jwnx] (last visited jan. 19, 2023) (presenting flowchart for determining individual eligibility to serve as pi). 91. see id. 92. norris, supra note 73, at 12; investigator manual, supra note 79, at p. 41. 93. jennifer l. gold & carolyn s. dewa, institutional review boards and multisite studies in health services research: is there a better way?, 40 health serv. res. 291, 291 (2005) (“recent years have seen a shift away from studies performed at single academic centers to larger, multisite projects involving numerous institutions in disparate geographic locations.”). 94. see norris, supra note 73, ch. v & vii (describing responsibilities of a clinical search coordinator (“crc”) or “qualified person” designated by the pi, including obtaining informed consent). 95. 45 c.f.r. § 46.102(a) (2023). 96. institutional review boards frequently asked questions, food & drug admin. (jan. 1998), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutionalreview-boards-frequently-asked-questions [https://perma.cc/yx9k-k2yg]. (for detailed regulations regarding the irb itself, see 45 c.f.r. §§ 46.107-109 (2023)). 2023] insider trading in the clinical trial setting 217 the rights and welfare of human research subjects. the purpose of irb review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. to accomplish this purpose, irbs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.97 an irb must have at least one member who is not affiliated with the entity, such as the medical school, that is conducting the trial.98 northwestern also requires that clinical trials be conducted in accordance with the ethical principles that have their origin in the helsinki principles.99 the helsinki principles are the most widely accepted statements of ethical principles in human clinical trials.100 b. financial interests and conflicts of interest financial interests on the part of anyone involved in the trial are pertinent not only to the integrity of the trial itself—so that no one might have an incentive to, for example, alter trial results—but also to claims for insider trading. these considerations are important in insider trading not only as indicative of a motive to misbehave, but also to the essential element of “benefit” in a claim of tipping.101 trial sponsors have a significant financial interest in the outcome of the trial they are funding, hoping that a marketable drug emerges. those carrying out a trial on the front line, such as a pi, may have a direct or indirect financial interest in the outcome. for example, the pi might be tempted to improperly influence people to enroll or to take action to affect the outcome of the trial as it 97. an irb must have at least one person not affiliated with the entity conducting the trial. 21 c.f.r. § 56.107(d) (2013). for an example of a confidentiality agreement between the irb members and a university, see confidentiality agreement, u. ky. (aug. 20, 2018), https://www. research .uky.edu/uploads/ori-f180000-irb-member-confidentiality-agreement-pdf. [https://perma.cc/2ell-cd9v]. 98. 21 c.f.r. § 56.107(d) (2023). 99. investigator manual, supra note 79, p. 43 (referring to wma declaration of helsinki – ethical principles for medical research involving human subjects, world med. ass’n, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medicalresearch-involving-human-subjects/#:~:text=1.,identifiable%20human%20material%20and%20data [https://perma.cc/56sd-teum] (last updated sept. 6, 2022) (hereinafter “helsinski principles”). 100. investigator manual, supra note 79, p. 43. at northwestern, the helsinki principles are “the basis for good clinical practices used today.” research ethics, nw. u., https://irb. n or th w es t e rn . edu / su bm it t in g-to -th e -irb /ge t t in g-s t a r t ed / resea rch -e th ics . h tml [https://perma.cc/vj8w-qgw2] (last visited jan. 19, 2023). 101. see supra text accompanying notes 42-43. 218 indiana health law review [vol. 20:199 proceeds.102 these interests—to get the trial off the ground and to skew some action to enhance the chance that the drug will be approved, such as altering a lab result to reflect favorable data—may have securities law, and in particular insider trading, implications. that is, the pi may know material negative facts that are inconsistent with positive information publicly disclosed by the sponsor about the progress of the trial, such as recruitment or interim results. trading while knowing the truth may be unlawful. these interests are potentially troublesome where employees of the sponsor or a pi own stock of the sponsor, so that an unsuccessful trial may provide an incentive to sell the stock before the negative information becomes public.103 ownership of sponsor stock is not generally prohibited, though it must be disclosed.104 northwestern, for example, has two conflict policies. one focuses on work outside northwestern.105 the second, most directly pertinent here, relates to research conducted under the auspices of northwestern.106 northwestern’s policy “promotes objectivity in research and establishes the university’s conflict of interest compliance framework.”107 to this end, anyone covered by the policy must report ownership of more than five-thousand dollars of stock of a public company.108 at northwestern’s feinberg school of medicine, however, any interest in any public company, no matter how small or when acquired, must be reported.109 102. see, e.g., jodi s. cohen, university of illinois at chicago missed warning signs of research going awry, letters show, pro publica (mar. 20, 2019), https://www.propublica.org/ article/university-of-illinois-ch icago-u ic-research-misconduct-let ters-documents [https://perma.cc/mfg5-nnlm] (reporting that medical institution terminated clinical trial and paid a $3.1 million penalty to the government because of, among other considerations, misconduct of pi). 103. see united states v. kosinski, 976 f.3d 135, 139, 141, 143 (2d cir. 2020). 104. see infra text accompanying notes 108-109. in the absence of publicly available policies in this regard, it is reasonable to speculate that some institutions do expressly prohibit ownership of sponsor stock, that institutions that do not prohibit it in so many words require internal disclosure to facilitate “managing” the potential conflict such as instituting a prohibition in practice. too much is at stake to run the risk of a disqualifying interest discovered ex post. 105. policy on conflict of interest and conflict of commitment, nw. uni. (jan. 22, 2018), https://www.northwestern.edu/coi/docs/core_coi_policy.pdf [https://perma.cc/9sq7-m9v3]. 106. see policy on conflict of interest in research, nw. u. (aug. 24, 2012), https://www. northwestern.edu/coi/policy/research_policy.pdf [https://perma.cc/w7s4-sd9s]. 107. id. 108. id. at 4. an important finding in the affirmance of kosinski’s conviction for insider trading was his failure to provide required information about his ownership trial sponsor stock. kosinski, 976 f.3d at 145 (“kosinski further agreed to disclose if his holding of [the sponsor’s] stock exceeded $50,000, which presumably would have triggered [its] closer oversight of kosinski (or even his termination) given its significance to the fda, and which he failed to do.”). 109. see policy on conflict of interest in research, supra note 106, § 4.1. see also conflict of interest – significant financial interests, nw. uni., https://www.northwestern.edu/coi/ 2023] insider trading in the clinical trial setting 219 noncompliance with these policies may play a role in a finding of insider trading liability. in kosinski, a factor in affirming his conviction for insider trading was his failure to provide required information about his ownership of stock in the trial sponsor.110 v. insider trading in the clinical trial setting – cases where the law has been applied since at least 1997, the sec has charged individuals in the pharmaceutical industry with insider trading based on mnpi regarding clinical trials.111 therefore, it is important to stress that those who trade based on mnpi regarding clinical trials are sometimes caught and when they are, they often suffer serious consequences, such as imprisonment, so that anyone involved in any trial should take steps to avoid, or at least reduce the risk of, a violation. the appendix is a hand-collected list of twenty-eight sec insider trading enforcement actions involving pharmaceutical industry clinical trials filed by the sec between january 1, 2012, and september 30, 2022.112 in eleven of those cases, there was also an indictment; all of the persons indicted were either convicted after a trial or pleaded guilty. undoubtedly, the overwhelming number of violations in any industry are not detected, and there is no way to determine how much insider trading escapes investigation. because of the sec’s limited resources, it is “impracticable for the staff to investigate or proceed in more than a small fraction of cases in which unlawful trading has likely occurred.”113 nevertheless, some are caught, and no disclosing/significant-financial-interests.html [https://perma.cc/8m44-x4ek] (last visited jan. 19, 2023). 110. kosinski, 976 f.3d at 145 (“kosinski further agreed to disclose if his holding of [the sponsor’s] stock exceeded $50,000, which presumably would have triggered [its] closer oversight of kosinski (or even his termination) given its significance to the fda, and which he failed to do.”). 111. see ferguson, supra note 9, at 631 (stating that the first such case was filed in 1997, referring to sec v. mutchnick, litig. release no. 15322, 1997 wl 169980 (apr. 10, 1997)). 112. seven percent of the insider trading cases filed in that period involved clinical trial mnpi. five cases were filed in just the sec’s fiscal year ending september 30, 2022. see app’x. the appendix shows that on average three cases filed each year were based on misuse of clinical trial mnpi. the total number of insider trading cases filed each fiscal year ending september 30 by the sec from 2017 (when the sec first included this category in its annual reports) to date have ranged from twenty-eight to fifty-one, averaging thirty-eight. see, e.g., s.e.c., div. of enf’t ann. rep. 20 (2018), https://www.sec.gov/files/enforcement-annual-report-2018.pdf [https://perma.cc/hv85pwl7] (fifty-one cases in court or at the sec, involving seventy-four individuals). more recently, see press release, s.e.c., sec charges former ceo of biotech company cytodyn with fraud, insider trading (dec. 20, 2022) (available at https://www.sec.gov/news/press-release/2022-232 [https://perma.cc/6cp3-97w4]) (reporting action filed alleging insider traded without disclosing negative reaction to company biologics license application). 113. see langevoort, supra note 1, § 8:1 (footnote omitted). 220 indiana health law review [vol. 20:199 one can be sure that her trading will not be. several cases involving clinical trial mnpi were noteworthy in showing how the law can be applied in that context and generally. one was kosinski,114 singled out as important when it was decided.115 the second was the controversial decision in united states v. martoma, where the second circuit court of appeals affirmed the conviction of martoma, a hedge fund manager, who paid gilman, a doctor involved in a clinical trial, for mnpi about the trial.116 martoma presented a controversial approach toward tipping that may been inconsistent with a prior second circuit panel opinion.117 gilman, a member of the safety monitoring committee for the trial, told martoma that he had identified “two major weaknesses in the data” that called into question the efficacy of the drug as compared to a placebo.118 on behalf of the portfolios he managed, martoma undertook transactions in securities of the trial sponsors that resulted in substantial profits and avoided losses for those portfolios.119 martoma’s conviction as a tippee was affirmed.120 though gilman, a doctor, was not indicted for tipping martoma, the sec sued him, and they settled.121 114. see supra text accompanying notes 22-25. 115. kosinski was the only insider trading case included in the aba business law section discussion of notable securities law cases in 2020. william o. fisher et al., caselaw developments 2020, 76 bus. law. 1069, 1117-21 (2021). 116. united states v. martoma, 894 f.3d 64 (2d cir. 2017) (two to one decision, the second panel decision in the case). see united states v. martoma, 869 f.3d 58 (2d cir. 2017) (two to one decision, first panel decision). one element of the disagreement among the panel members related to the meaning of the comma in the last sentence of the quote from dirks, supra text accompanying note 46. see martoma, 894 f.3d at 74 (majority opinion), 84-85 (dissenting opinion). 117. criminal law –insider trading –second circuit redefines personal benefit requirement for insider trading—united states v. martoma, 894 f.3d 64 (2d cir. 2018), 132 harv. l. rev. 1730 (2019) (discussing martoma’s “stealth overruling” of a prior second circuit panel decision). 118. martoma, 894 f.3d at 69-70. the practice of securities professionals paying doctors involved in trials to provide nonpublic information had become commonplace. see david heath & luke timmerman, drug researchers leak secrets to wall st., seattle times (may 12, 2005), h t t ps :/ / special.seat t let imes.com/o/h tml/businesstech n ology/dru gsecre t s1 .h tml [https://perma.cc/z5r2-hnyf] (reporting finding at least twenty-six cases in which doctors leaked “confidential and critical details” of their ongoing drug research to wall street firms, in twenty-four of which “the firms issued reports to select clients with detailed information obtained from doctors involved in confidential studies” and which advised clients whether to buy or sell a drug stock). this practice continues in the form of “expert networks” which provide what may be mnpi to members of the investment community. see langevoort, supra note 1, § 11:5 (discussing legal and unlawful expert networks). experts can easily be found with a google search for “medical expert network clinical trial.” 119. martoma, 894 f.3d at 70. 120. id. at 68. 121. sec v. cr intrinsic inv’s llc, litig. release no. 22539, 2012 wl 5872931, at *2 (nov. 20, 2012) (reporting gilman’s settlement). 2023] insider trading in the clinical trial setting 221 the deception theory of insider trading has been invoked in a clinical trial setting. a researcher for a brokerage firm allegedly “sent his brother, a research assistant at the firm, to impersonate him by signing up to participate in the clinical trial of the drug” to learn information about the trial. the firm published a research report five days later recommending the sale of the stock of the manufacturer of the drug, citing a side effect the phony applicant learned about when registering for the trial. after public disclosure of this information, the stock fell by a third. the brokerage firm, the firm’s researcher, and his brother all quickly settled charges by the national association of securities dealers, their principal self-regulator in the securities industry.122 in another deception case, the sec alleged that a former fda employee, consulting for an investment advisor at the time, deceived a former fda colleague still working there to obtain mnpi about the status of the trial that he passed on.123 that defendant settled the case.124 someone working on a clinical trial may learn mnpi about the sponsor that has nothing to do with the drug under investigation. the “insider” who is told about some nonpublic impending development, such as an acquisition, and then trades in the securities of the issuer may have violated the law, such as a consultant on one matter who learns of another development.125 if the pi is deemed a temporary insider of the sponsor, and if the pi trades based on the mnpi about the acquisition, he may have exposure to an insider trading claim.126 professor langevoort, noted that “where a person who is an insider under the [classical theory] overhears fellow insiders talking about a material development . . . because of the insider’s fiduciary status, he is precluded from using the information.”127 any information he hears about the company might be within the scope of any confidentiality agreement he signed in connection with the trial. that agreement may provide the foundation for a misappropriation claim. in the potentially groundbreaking misappropriation case sec v. panuwat, the sec alleged that information about one company in the pharmaceutical field was material to the value of the stock of an “economically linked” company, even one 122. randall smith, sterling financial, employees are punished in “‘posing’ case nasd imposes fine, suspension on biotech analyst, his brother, wall st. j. (oct. 29, 2002), https://www.wsj.com/articles/sb1035843978859763871 [https://perma.cc/88kf-j3cy]. 123. press release, sec, hedge fund managers and former government official charged in $32 million insider trading scheme (june 15, 2016) (available at https://www.sec.gov/news/ pressrelease/2016-119.html [https://perma.cc/qxv3-j8vy]) (alleging that deception was used to obtain mnpi in cmpl., at ¶¶ 62, 66, 77). 124. see sec v. valvani, litig. release no. 23688, 2016 wl 9086445 at *1 (nov. 14, 2016). 125. see, e.g., sec v. glassner, litig. release no. 25398, 2022 wl 1644020 at *1 (may 24, 2022) (reporting filing of action against compensation consultant for pharmaceutical company who “learned about [his client’s] impending acquisition by global biopharmaceutical company sanofi s.a. in the course of his engagement to provide acquisition-related consulting services to kadmon” and soon thereafter bought stock of the client). 126. see infra part vi (discussing scenarios). 127. langevoort, supra note 1, § 4.7 n.10. 222 indiana health law review [vol. 20:199 that was not a counterparty to or otherwise involved with the first company.128 the sec contended that when the defendant learned mnpi that his pharmaceutical employer was going to be acquired at a substantial premium, he purchased the stock of another company in the same “mid-cap oncology-focused biopharmaceutical” field, believing that it would be seen as a target of other buyers on the prowl. the trader was not alleged to have had any mnpi regarding the other company itself. the court held that this stated a plausible misappropriation insider trading claim.129 the propensity of the sec to push the limits of the law should give rise to a clarion call for those who trade securities to be wary of how the sec will use the current outcome in panuwat to press its agenda. there are important scenarios other than panuwat, not yet the subject of claims by the sec and much less adjudicated, that must be addressed if one is to appreciate the full range of the potential application of the prohibition on insider trading involving mnpi about a clinical trial. these are addressed in part vi. vi. insider trading in the clinical trial setting – applying recognized principles the analysis to this point demonstrates that the pi and the rest of the clinical trial team are likely to violate rule 10b-5 if they trade in the stock of the sponsor when they know mnpi about the trial. they are exposed as insiders (or temporary insiders) as well as potential mis-appropriators, arising out of a relationship of trust and confidence with the sponsor, if only because—as is generally the case—there is a confidentiality agreement that creates that relationship, as under rule 10b5-2(b)(1). the net in clinical trial cases has been cast very wide, for example, pursuing an outside investor relations consultant who used mnpi about a clinical trial of a pharmaceutical firm client of his, among others.130 analyses of scenarios not yet the subject of a claim by the sec 128. sec v. panuwat, no. 21-cv-06322, 2022 wl 633306 at *9 (n.d. cal. jan. 14, 2022) (denying motion to dismiss). see also infra text accompanying note 254 (for a further discussion of panuwat). see, e.g., celeste koeleveld, shadow trading – the sec’s novel theory of insider trading to be tested, clifford chance (aug. 27, 2021), https://www.cliffordchance.com/ briefings/2021/08/shadow-trading---the-sec-s-novel-theory-of-insider-trading-to-be.html [https://perma.cc/6xm4-4dcu]. (the complaint suggests that the sec may attempt to expand the scope of insider trading liability to include a theory a recent academic paper dubbed “shadow trading”: where corporate insiders exploit material nonpublic information about their firm, to trade in the securities of an “economically linked” firm, such as a similarly situated competitor.). 129. sec v. panuwat, no. 21-cv-06322, 2022 wl 633306, at *1-2 (n.d. cal. jan. 14, 2022). 130. see press release, sec charges investor relations firm executive with insider trading ahead of news announcements by clients (aug. 26, 2014) (available at https://www.sec.gov/ news/press-release/2014-175 [https://perma.cc/yjl3-nb7y]). the defendant pleaded guilty to a related indictment and was sentenced to two-and-a-half years in prison. see also press release, u.s. attorney’s office for the southern district of new york, former director of market intelligence at investor relations firm sentenced in manhattan federal court for insider trading (jan. 21, 2023] insider trading in the clinical trial setting 223 follow. while there is no current reason to believe some of the claims described here are on the immediate horizon, they could be – the vigilant must take that risk into account. a. participant enrollment phase these authors are not the only science and legal professionals concerned about the potential breadth of clinical trial insider trading claims, as more than fifteen years ago, four medical and legal authors asked what “if any, are physician–investigators’ scientific, ethical, and legal responsibilities concerning research subjects who choose to buy stock in the companies sponsoring the clinical trials in which they are participating.”131 with these concerns in mind, we begin with the protocols that must be followed when persons are recruited and enrolled as “participants” in a clinical trial. pis must comply with requirements of their institution, the fda, the irb of record, and the sponsoring company.132 first and foremost, there must be informed consent by anyone enrolled in a clinical trial, evidenced by signing an informed consent form (icf).133 complete candor by the investigation team is required. in medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. participants can be identified using hospital diagnostic records, support group membership lists, lab screening records, and physician referrals.134 participants 2015) (available at https://www.justice.gov/archive/usao/nys/pressreleases/january15/lucarelli michaelsentencingpr.php?print=1 [https://perma.cc/2cyj-cb6r]). 131. helft, supra note 9, at 656. 132. see generally 45 c.f.r. § 46 protection of human subjects, especially subparts a (basic hhs protection of human research subjects); and e (registration of institutional review boards). the process is described at norris handbook, supra note 73, ch. x. 133. 45 c.f.r. § 46.116(a)(1). some of the requirements imposed on a medical doctor acting as a pi parallel provision of the ama ethical principles. see ama, principles of med. ethics (june 2001), https://www.ama-assn.org/about/publications-newsletters/ama-principles-medicalethics [https://perma.cc/6mka-8z22], and code of med. ethics, https://www.ama-assn.org/ delivering-care/ethics/code-medical-ethics-overview [https://perma.cc/zz3m-uf3e] (last visited jan. 19, 2023) (containing links to the individual chapters and opinions) [hereinafter ama opinions] (containing links to the individual chapters and opinions). see also northwestern univ., permission to take part in human research study, form hrp-592, passim (revised june 27, 2022), https://irb.northwestern.edu/resources-guidance/consent-templates-hipaa-requirements/ biomedical-social-behavioral-consent-templates/index.html [https://perma.cc/3p8v-75cg]. to the same effect, see investigator manual, supra note 79, at app. a-3, pp. 41, 43. 134. norris, supra note 73, at 67. the privacy rule under the health insurance portability 224 indiana health law review [vol. 20:199 can be solicited using general media advertising, posters in waiting rooms or doctor’s offices, newsletters to patients, and health fairs.135 initial screening can be done in person or by phone.136 while there is limited evidence that anyone enrolls in a trial to obtain mnpi about the sponsor in the recruiting phase,137 there could be disclosures to the prospect that could pose an insider trading issue. is mnpi revealed by the pi to the participant in confidence in the recruiting phase, supplying the potential predicate for a misappropriation claim? when discussing potential enrollment and obtaining consent the fda requires that a potential participant “must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information,”138 including “a concise and focused presentation of the key information that is most likely to assist a prospective subject . . . in understanding the reasons why one may or may not want to participate in the research.”139 one important disclosure – where permitted – is the identity of the sponsoring entity and the name of the drug under investigation.140 “an investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.”141 the potential participant must be informed from whom he can obtain “answers to pertinent questions about the research and research subjects’ rights,”142 and “whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.”143 there are limits on what can be done. “neither the investigator, nor the trial and accountability act (hipaa) applies to protect information obtained from and about the trial participant in some clinical trials. see hhs, summary of the hipaa privacy rule (july 26, 2013), https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html#:~:text=the%20 privacy%20rule%20protects%20all,health%20information%20(phi).%22 [https://perma.cc/3f8ga4s7]; hhs, research (dec. 18, 2017), https://www.hhs.gov/hipaa/for-professionals/specialtopics/research/index.html [https://perma.cc/fvw7-ew6c]. the question of the extent to which paa requirements might have to be complied with in a clinical trial (see norris handbook, supra note 73, at 53-54; investigator manual, supra note 79, at 17) is beyond the scope of the analysis here. 135. norris, supra note 73, at 67-68. 136. id. at 69. 137. see supra text accompanying note 122 (discussing case). 138. 45 c.f.r. § 46.116(a)(4). 139. 45 c.f.r. § 46.116(a)(5)(i). 140. the northwestern irb provides that the identity of the drug be disclosed to the participant “whenever appropriate.” northwestern univ. permission, supra note 133, at 4, 14. 141. 45 c.f.r. § 46.116(a)(2). 142. 45 c.f.r. § 46.116(b)(7). 143. 45 c.f.r. § 46.116(c)(1), (c)(8). 2023] insider trading in the clinical trial setting 225 staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial.”144 the american medical association (“ama”) cautions physicians to “refrain[] from persuading the individual to enroll.”145 at northwestern, the potential participant is to be told, “[y]ou can ask all the questions you want before you decide”146 and be informed who he can talk to if he has any questions, including the irb.147 this requires meaningful responses to those inquiries, as no information can be withheld.148 all questions are to be answered “to the satisfaction of the subject.”149 persons involved in face-to-face encounters at the intake phase should be attuned to the risk that someone might be feigning interest in the trial as a means of learning mnpi they would use to trade.150 while the person who engages in deception to obtain information which is then used to trade may violate rule 10b5, the pi who is tricked is not exposed,151 at least so long as he does not know he is providing more information than necessary to be responsive such that he might be a tipper.152 one case presents a perspective on how legally mandated clinical trial disclosures that might be material can be reconciled with a potential tipping claim. in fifth third bancorp v. dudenhoefer, the supreme court addressed a claim of trustee imprudence in oversight of retirement plan assets covered by the employee retirement income security act of 1974 (erisa).153 the court explained how erisa and the federal securities laws intersect in making investment decisions affecting ownership of company stock held as a plan asset in an employee stock ownership plan (esop), “a retirement plan in which an employer contributes its stock to the plan for the benefit of the company’s employees.”154 the plaintiffs alleged that mnpi known to the (insider) plan trustees suggested that the company stock was overvalued. they contended that 144. investigator manual, supra note 79, app. a-3, item 7.c, p. 43. see also 45 c.f.r. § 46.116(a)(2) (providing that person obtaining informed consent shall “minimize the possibility of coercion or undue influence” when seeking consent). 145. see ama opinions, informed consent in research, supra note 133, at opinion e-7.1.2. 146. northwestern univ. permission, supra note 133, at 2. 147. id. at 3. 148. in the doctor-patient context, see ama opinions, supra note 133, at opinion 2.1.3 (“withholding pertinent medical information from patients in the belief that disclosure is medically contraindicated creates a conflict between the physician’s obligations to promote patient welfare and to respect patient autonomy.”). 149. investigator manual, supra note 79, app’x a-3, item 9(g), p. 44. 150. see supra text accompanying notes 122 (describing such a case). 151. see supra text accompanying note 122. 152. see supra text accompanying notes 42-49. 153. fifth third bancorp v. dudenhoefer, 573 u.s. 409 (2014) (addressing issues under 29 u.s.c. § 1104(a)(1)). 154. sec, employee stock ownership plans esops, invester.gov, https://www.investor. gov/introduction-investing/investing-basics/glossary/employee-stock-ownership-plans-esops [https://perma.cc/nf7y-82eb] (last visited jan. 19, 2023). 226 indiana health law review [vol. 20:199 the trustees could have used the information by selling the stock held by the esop, refraining from buying more stock, or making public disclosure of the mnpi.155 the court stated: to state a claim for breach of the duty of prudence on the basis of inside information, a plaintiff must plausibly allege an alternative action that the defendant could have taken that would have been consistent with the securities laws and that a prudent fiduciary in the same circumstances would not have viewed as more likely to harm the fund than to help it.156 further, “[t]he duty of prudence . . . does not require a fiduciary to break the law . . . erisa’s duty of prudence cannot require an esop fiduciary to perform an action—such as divesting the fund’s holdings of the employer’s stock on the basis of inside information—that would violate the securities laws.”157 as explained by professor langevoort, “[t]he court has made clear that erisa’s fiduciary status affords no license (much less responsibility) to engage in unlawful insider trading.”158 this principle should apply equally to requirements imposed by the fda, so that making the disclosures required by the fda to obtain informed consent cannot be unlawful and thus cannot expose the pi to a tipping claim, even if the pi is seeking to achieve a benefit, such as enrolling the minimum cohort to be able to proceed with the trial.159 if, however, the person doing the intake makes more disclosure than required by fda rules, consideration should be given to whether he was acting for an improper purpose especially if enrollment might produce a benefit for the person making the disclosure, satisfying one crucial element of unlawful tipping. that is, if the pi provides more information than is required to be disclosed, to persuade the person to enroll, this might be unlawful tipping because the pi is seeking to benefit himself by enhancing his reputation leading to increased compensation or receiving increased compensation directly.160 of course, if he has no expectation that the prospect will trade in sponsor securities, there is no unlawful disclosure. cash is the paradigm benefit, as gilman received in martoma.161 another 155. dudenhoefer, 573 u.s. at 427-28. 156. id. at 428 (emphasis added). 157. id. at 428 (citation omitted). 158. langevoort insider trading, supra note 1, at § 3:1. 159. this question may implicate complex questions of pre-emption, such as those addressed in pliva, inc. v. mensing, 564 u.s. 604 (2011), where the court held that fda regulations preempted state labeling laws because it was impossible for the drug manufacturers to comply with state law without violating federal law. 160. see supra text accompanying note 45. as stated in dirks, it is not mere reputational benefit, but rather a benefit “that will translate into future earnings.” dirks, 463 u.s. at 663. 161. see martoma, 894 f.3d at 71 (discussing cash payments to gilman in exchange for his tip). more recently, the sec alleged that tips about a clinical trial were paid for with cash. see sec v. rayapureddy, 2:22-cv-01592-wsh (w.d. pa, 2022), https://www.sec.gov/litigation/complaints/ 2023] insider trading in the clinical trial setting 227 concrete benefit to the pi or to his institution is that there are enough enrollees to proceed.162 there might be monetary rewards to the institution that employs the pi through commercial exploitation of the drug, or even to the pi himself, such as earning patent royalties if the trial drug is successfully marketed.163 enhancement or preservation of reputation might satisfy the “benefit” element of tipping, as noted in dirks, the seminal tipping case, at least when it is expected to enhance the income of the tipper in the long run.164 if the person to whom the pi-tipper made excess disclosure – the prospective enrollee – then traded based on mnpi, that tippee-trader could be an unlawful tippee.165 the prospective participant herself could not be a “temporary insider” before she is enrolled.166 there could be no pre-enrollment relationship of “trust and confidence” between the pi and the prospect, even if the pi were an m.d., though it might evolve to embrace some aspects of the traditional doctor-patient relationship for those who participate.167 while the northwestern consent form 2022/comp-pr2002-204.pdf [https://perma.cc/ab77-89g9]. 162. see, e.g., nat’l inst. of allergy & infectious diseases, div. of aids (daids) site clinical operations & research essentials (score) manual: premature termination or suspension of a clinical trial, at 2 (jan. 19, 2021), https://www.niaid.nih.gov/sites/default/ files/score-premature-termination-or-suspension-of-clinical-trial.pdf [https://perma.cc/695ugwux] (listing as a reason for early “fails to enroll participants within a requisite time period”). 163. see supra text accompanying notes 101-102 (discussing potential tangible benefits). the fda requires disclosures of these interests. 21 c.f.r. § 54 (2023). one notable example of the realization of significant royalties in connection with a clinical trial is described by daniel p. smith, the pregabalin story: how northwestern university transformed a $681,764 grant into a fortune of good, northwestern univ. invo news archive (apr. 1, 2017), https://www.invo. northwestern.edu/about/news/news-archive/the-pregabalin-story.html [https://perma.cc/3q73jbbd] (describing the royalties received by northwestern for pregabalin (lyrica), which had been discovered by a northwestern chemistry professor and a visiting colleague, and that pfizer royalties are responsible for about 18 percent of the university’s endowment, “[f]irst spurred by a $681,764 grant from the national institutes of health in 1987”). 164. see supra text accompanying note 45 (quoting dirks). see also sec v. stevens, litig. release no. 12813, 48 sec docket 841 (1991) (describing complaint alleging that when it appeared that company would report earnings lower than expected defendant called analysts to give them advance notice of the impending announcement “in order to protect and enhance his reputation. the complaint alleges that that action was seen by [defendant] as having direct, tangible benefit to his status as a corporate manager.”). 165. see supra text accompanying notes 42-49 (describing elements of tipping). 166. see supra text accompanying note 16 (describing “temporary insider”). 167. the relationship between the pi who is an m.d. and trial participant differs from the relationship with a treating physician. the participant must be informed of “the differences between the physician’s responsibilities as a researcher and as the patient’s treating physician.” ama opinions, supra note 133, opinion e-7.1.2(c)(ii). at the same time, the physician should “[d]emonstrate the same care and concern for the well-being of research participants that they would for patients to whom they provide clinical care in a therapeutic relationship. physician researchers should advocate for access to experimental interventions that have proven effectiveness 228 indiana health law review [vol. 20:199 contains many explicit references to maintaining the privacy of the participant’s information, it makes no reference to the participant maintaining the confidentiality of anything she learns.168 rather, it expressly permits the potential participant to “discuss this study with another person who is not part of the research team before deciding whether to participate in the research.”169 thus, though perhaps unlikely at the recruiting stage, tipping could become an issue or something could occur to create a relationship of trust and confidence.170 if there is any potential insider trading exposure for sharing information at this stage, the organization conducting the trial could – before making any but the most basic introductory disclosures to a prospective enrollee – require that the prospect sign a confidentiality agreement covering any information provided in the enrollment process. consideration of whether to enter into a confidentiality agreement should consider that it would create a relationship of trust and confidence, applying rule 10b5-2(b)(1). this creates a risk for the participant by creating the foundation for the application of the misappropriation theory if she trades. is it worth the benefit of obtaining enrollment to expose the eventual participant to liability under that theory, remote though the risk may be? a confidentiality agreement is neither mandated nor recommended by the fda,171 nor is it listed on the northwestern icf, which, in any event, is signed only upon enrollment, not before.172 upfront confidentiality agreements in the nonpublic testing setting are not unheard of, however. one parallel is the confidentiality agreement obtained from a person who does “beta testing” of computer software.173 outsiders are given nonpublic information to provide, with for patients. id. at e-7.1.1(d). the fda requires disclosure to the participant of “appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject” when seeking consent. 45 c.f.r. § 46.116(b)(4). to the same effect, see investigator manual, supra note 79, at 45. 168. investigator manual, supra note 79, passim. 169. id. at 1. while this reads in the singular, it seems unlikely that a prospect is to be limited to speaking to only one other person. 170. if there is a prolonged period of recruitment efforts between a pi and a potential participant, sec rule 10b5-2(b)(2) might come into play. that provides that there is a relationship of trust and confidence if two persons develop “a history, pattern, or practice of sharing confidences, such that the [participant] … knows or reasonably should know that the [pi] … expects that the [participant] will maintain [information’s] confidentiality.” 17 c.f.r. § 240.10b52(b)(2). frequent one-on-one discussions, especially face-to-face, may produce the kind of intimate relationship that often arises in the traditional doctor-patient setting over time. see also complaint at ¶ 24, sec v. rayapureddy, 2:22-cv-01592-wsh (w.d. pa, nov. 10, 2022), https://www.sec. gov/litigation/complaints/2022/comp-pr2002-204.pdf [https://perma.cc/lx46-j76y] (alleging that “close personal relationship is shown by “regularly spoke on the telephone, messaged each other, and socialized in person”). 171. 45 c.f.r. § 46 (2023). 172. northwestern univ., supra note 133. 173. 1 l. j. kutten, computer software protection/liability/law/forms § 3:19, at 3-23, 25 (2005) (“beta testing of software occurs when the software is stable enough so that parties 2023] insider trading in the clinical trial setting 229 or without compensation, their analysis or reaction to the product in the development stage. because there is a confidentiality agreement between the members of the irb, notably the required non-affiliated member of the irb, and the university for which it functions, irb members who receive mnpi cannot trade in the stock of a sponsor.174 the adverse implications of obtaining a confidentiality agreement are extremely speculative, though before dismissing the topic altogether the issues that could arise should be understood. obtaining a confidentiality agreement from the participant at any stage of the clinical trial process raises many practical issues. first, requesting an agreement at the outset might have a chilling effect. the participant might ask herself, “what is so secret about this that i can tell only a few persons?” and conclude that the information to be kept secret must be negative. the impact that a request for a confidentiality agreement could have to discourage enrollment when recruiting for clinical trials is counter to the public policy of encouraging and facilitating the development of new drugs. while the focus of the fda regulations described throughout this article is the safety of trial participants, the fda also seeks to foster development of new drugs that are effective.175 an agreement, at this stage or any time during the trial, might give the relationship an adversarial or at least party-counterparty flavor, potentially undermining the mutual candor desired in the pi-participant relationship, especially if there is a conventional doctor-patient relationship. this promise of confidentiality could be set forth in the icf itself, not as a separate document, but included with other prohibitions and cautions. it could expressly cover pre-enrollment disclosures. this is also a good place to include prohibitions on posting on social media.176 a promise of confidentiality, even if included only somewhere in a lengthy document with many independent provisions, would likely be binding on the participant in the absence of a successful conventional contract defense such as fraud, duress, or unconscionability. enforceability presents questions of contract law of the jurisdiction whose law applies that are beyond the scope of this article. the participant’s failure to read the agreement, standing alone, is not outside the developing organization may participate in the debugging, testing, and evaluation . . . in setting up a beta-test agreement, the tester must . . . sign a confidentiality agreement . . .”). for a current template including a confidentiality agreement for beta testing, see beta test agreement ¶ 2, https://www.upcounsel.com/beta-test-agreement [https://perma.cc/3jx6-xljg]. 174. see confidentiality agreement, supra note 97. 175. “fda is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” fda, what we do – fda mission (mar. 28, 2018), https://www.fda.gov/ about-fda/what-we do#:~:text=fda%20basics fda%20mission,and%20products%20that%20emit%20radiation [https://perma.cc/z57g-fs68] (emphasis added). 176. see infra text accompanying notes 223-224 (discussing chatrooms). 230 indiana health law review [vol. 20:199 ordinarily a defense.177 the seventh circuit has held that “a software license agreement ‘encoded on the cd–rom disks as well as printed in the manual, and which appears on a user’s screen every time the software runs’” was valid because the buyer has an opportunity to read the license.178 the court also found that “[s]hrinkwrap licenses are enforceable unless their terms are objectionable on grounds applicable to contracts in general (for example, if they violate a rule of positive law, or if they are unconscionable).”179 in the clinical trial enrollment setting, there is to be no pressure on the person to enroll and the keystone of the informed consent process is full disclosure and responsiveness to questions, factors which, if satisfied, should counter any argument of duress, for example. another issue is the scope of any agreement. the prospect cannot be expected to agree not to disclose important information about the trial to her primary care physician (pcp),180 or to her spouse, children, and others she might consult or inform when deciding whether to enroll as well as after enrollment. moreover, any treating physician should be informed of the participant’s involvement in the trial.181 for this reason, the participant should carry a card that states he is in a trial, identifying the trial, so that in an emergency anyone treating the participant can take this information into account. under insider trading law trading may be prohibited even if there is no agreement not to trade in addition to an agreement to keep information confidential.182 the confidentiality agreement is enough to establish the relationship of trust and confidence, at least under rule 10b5-2(b)(1), to trigger misappropriation. in any event, if the principal concern is that anyone involved in the trial does not trade, rather than a sweeping agreement not to reveal confidential information a middle ground could be an express agreement only not to buy or sell any securities of the trial sponsor. requesting this agreement from a layperson, however, might be like telling her, “don’t think about elephants,” planting an idea that might never have occurred to her, especially in this nonfinancial setting. moreover, it does not address tipping or trading in a stock other than that of the sponsor, as in panuwat, for example. nor does this narrowly 177. see, e.g., ballas v. virgin media, inc., 18 misc.3d 1106(a), 2007 wl 4532509, at *3 (n.y. sup. ct. 2007) (“a party is under an obligation to read a document before accepting its terms and cannot avoid the effect of the document by asserting [that] he or she did not read or understand [its] contents . . .”), aff’d 60 a.d.3d 712 (2009) (applying new york law). 178. procd, inc. v. zeidenberg, 86 f.3d 1447, 1451-52 (7th cir. 1996). 179. id. at 1449. 180. at northwestern, pis are encouraged, with the participant’s approval, to tell a participant’s pcp about the participant’s involvement. investigator manual, supra note 79, appendix a-3 at 42. 181. see, e.g., joan antoni schoenenberger-arnaiz et al., informing primary care physicians of patients’ involvement in clinical trials carried out at a specialist care level, 9 open access j. clinical trials 59 (2017). 182. see o’hagan, 521 u.s. at 656 (“[f]raud is consummated, not when the fiduciary gains the confidential information, but when, without disclosure to the principal, he uses the information to purchase or sell securities.”). 2023] insider trading in the clinical trial setting 231 tailored approach preclude trading by the prospect’s pcp and others to whom the prospect might provide mnpi she has learned in this setting, as they are not parties to the agreement.183 thus, at the pre-enrollment stage, insiders, temporary insiders, and those on the research side of the process who have a relationship of trust and confidence with the sponsor in which they obtained mnpi about the trial will likely violate rule 10b-5 if they trade. the potential enrollee, however, could violate rule 10b5 only if she was tipped by any of those persons and then traded, or something in the process created a relationship of trust and confidence. measures to avoid or discourage wrongful conduct are addressed in part vii. b. active trial phase most insider trading cases in the pharmaceutical field have involved an insider of a sponsor, a pi, or other person who learned mnpi about the trial and then traded or tipped based on that information, as in kosinski and martoma. beyond those scenarios, the devil is in the details.184 1. potential securities law liability arising from trading based on or disclosing mnpi during the trial and other concerns a. risk to the trial itself from a securities law violation or other misconduct though not a securities law issue per se, perhaps first and foremost from the perspective of the trial sponsor, the pi, and the latter’s institution, any conduct by a participant that might compromise the trial, even lead to its termination, must be avoided.185 a trial can be adversely affected, for example, by premature disclosure of nonpublic information on social media. the mother of a boy with duchenne muscular dystrophy heard through facebook that the trial her son was participating in had been stopped. to learn this devastating news this way was most unfortunate. moreover, this causes those in the trial to try, more than usual, to find out which participants received the drug, and which received the placebo. this could lead to unblinding everyone, with some participants leaving the trial, potentially impairing the usefulness of the results of the trial.186 183. tipping can be a simple “thumbs up.” where a wife broke a promise to her husband not to reveal mnpi regarding his company, the court found that the sec sufficiently alleged that she tipped her brother when she called him “and gave him ‘a wink and a nod’ regarding [the company]. [the brother] interpreted this to mean that he should sell” his stock in the company and did so. sec v. rocklage, 470 f.3d 1, 4 (1st cir. 2006). 184. see, e.g., supra note 116 (describing the disagreement between the majority and dissent in martoma regarding the meaning of a comma in dirks). 185. 45 c.f.r. § 46.113. 186. bibiana campos seijo, concerns over social media and clinical trials, chem. & eng. news (nov. 18, 2018), https://cen.acs.org/pharmaceuticals/drug-development/concerns-oversocial-media-clinical/96/i46 [https://perma.cc/bp5n-dy2g]. 232 indiana health law review [vol. 20:199 the duchenne situation is a paradigm example of what not to do. this may become a serious issue with regard to the integrity of trials: one potential concern is the use of online forums by variously interested persons or organizations with the intent of influencing the outcome of a clinical trial. this can occur when the forum collects information from study participants that is not otherwise publicly available (such as impressions of a study drug’s efficacy, or the frequency of certain adverse events). we did not see any clear evidence of this in our searches, although we are aware of cases in which online forum postings by self-identified study participants have been cited as source material by journalists and financial analysts. potential misuse could theoretically come at the hand of researchers, competing pharmaceutical companies, the financial sector, journalists, or any individual who has a stake in the success (or failure) of a drug in development. for example, parties could enter online forums with the aim of discouraging subjects from participating in trials, to solicit information directly from subjects that is not publicly available, or to post misinformation about study-related issues (such as adverse events).187 b. potential rule 10b-5 liability for (a) classical trading, (b) misappropriating to trade, or (c) tipping as in kosinski188 and martoma,189 as a clinical trial proceeds, those involved on the sponsor/investigator side may cross the line into unlawful territory by trading or tipping. disclosures may be made to participants.190 individual participants will observe not only their own apparent response to the drug but possibly that of other trial participants, such as persons with whom they interact in a waiting room, the infusion or treatment area, or a support group.191 information about a participant’s medical status might also be shared with her pcp, who might piece together information about multiple participants among his patients or those of other physicians which was revealed as a doctor-patient 187. seth w. glickman et al., the potential influence of internet-based social networking on the conduct of clinical research studies, 7 j. emp. rsch. on hum. rsch. ethics 71, 77 (2012). 188. see supra text accompanying notes 22-25. 189. see supra text accompanying notes 118-21. 190. disclosure to the participant about her situation is not mandated by the fda. see, e.g., 45 c.f.r. § 46.116(c)(8) (2018) (specifying that the participant be provided “[a] statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions”) (emphasis added). the fda’s rules provide, however, that “[w]hen appropriate” the icf should include “[a] statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.” 21 c.f.r. § 50.25(b)(5) (2017). 191. see infra text accompanying note 202 regarding the materiality of this information. 2023] insider trading in the clinical trial setting 233 confidence.192 in the active trial stage, a participant is still neither a traditional insider nor a temporary insider of the trial sponsor,193 unlike the pi who could be either. the classical theory thus does not apply to information the participant learns from the research team or from other participants. this shifts the analysis to the misappropriation theory and to tipping. clinical trial protocols include numerous pledges of confidentiality to the participant. applying the misappropriation theory must consider whether there is a relationship of trust and confidence based on the agreements and understandings particular to the specific trial or participant. what the pi tells the participant about the participant’s own situation, or any other information about the trial, is not ordinarily told in confidence, there is no relationship of trust and confidence unless rule 10b5-2(b)(2) applies to the facts, i.e., depending on the creation of a relationship between the parties during the interactions. participants would not ordinarily have a relationship of trust and confidence with their fellow trial participants unless (1) a disclosure to the fellow participant is expressly made in confidence, such as when one participant tells someone else, asking her to keep it confidential, and the recipient agrees,194 or (2) the parties have developed a practice of sharing confidences as they bond during the trial.195 what one participant simply observes about someone in the next infusion chair is not, without more, confidential. after the participant is already enrolled, the prospect of obtaining a confidentiality agreement from her, which, applying rule 10b5-2(b)(1), would create a relationship of trust and confidence, may be remote. obtaining an agreement, even one that does no more than preclude trading in the stock of the sponsor, has the shortcomings noted earlier.196 moreover, if a team were to request a confidentiality agreement for the first-time mid-trial it might provoke a suspicion that something really important, likely negative, has happened. she might withdraw from the trial – an option she can exercise at any time.197 withdrawals in substantial numbers could jeopardize the completion of the trial.198 the pi does not want to run that risk. 192. see supra text accompanying notes 26-27 (involving psychiatrist-patient confidentiality). 193. see supra text accompanying notes 166-67. 194. whether there has been assent, such as by silence, is a matter of general contract law. 195. see willis, supra notes 28-29; see also, supra note 170 (discussing sec rule 10b52(b)(2)). 196. see supra text accompanying note 175. 197. 45 c.f.r. § 46.116(b)(8) (2019); northwestern univ., supra note 133, at p. 4. 198. see david b. fogel, factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review, 11 contemp. clin. trials comm. 156 (sept. 11, 2018), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6092479/ [https://perma.cc/6j9rqu5v] (discussing reasons for termination of clinical trials); rebecca j. williams et al., terminated trials in the clinicaltrials.gov results database: evaluation of availability of primary outcome data and reasons for termination, plos one (may 15, 2015), https://www.ncbi.nlm. nih.gov/pmc/articles/pmc4444136/pdf/pone.0127242.pdf. [https://perma.cc/z6z7-vjkr]. 234 indiana health law review [vol. 20:199 suppose the pi meets with the participant and tells her that the trial is being terminated because the results are tending strongly negative or because funding has run out. he may make this disclosure so that the participant knows that she may no longer have access to the drug.199 public disclosure of termination often has a dramatic effect on the sponsor’s stock price, confirming its materiality.200 suppose further that the participant acts quickly, before a public announcement, selling any stock she owns in the sponsor or buying a put option on the sponsor’s stock, avoiding a loss or profiting on the sale of the puts. this disclosure by the pi may have breached a duty of confidentiality owed by the pi to the institution that employs him or to the trial sponsor. his disclosure may thus have been a breach that was an element of an unlawful tip. the participant’s trade would not have been an unlawful tippee trade, however, if she did not know or should not have known that the pi breached a duty in revealing the information.201 trading by the participant also would have been misappropriation only if there was a relationship of trust and confidence between the pi and the participant, such as a confidentiality agreement or a newly developed personal relationship within rule 10b5-2(b)(2). alter the facts a bit. the pi tells the participant that he has some information the participant might be interested in, but the pi can reveal it only if the participant agrees to keep it confidential. the participant agrees and the pi then tells her that the research team has unblinded the results and this participant, whose condition has improved during the trial, was one who received the drug, not a placebo. the participant now purchases the sponsor’s stock, hoping to profit on a rise in the stock price after this favorable information is made public. begging the fundamental question whether the information revealed to the participant only about herself is material,202 this trade could trigger the misappropriation theory, because the oral pledge of confidentiality by the participant created a relationship of trust and confidence between the pi and the participant, which the participant has breached by trading.203 if the participant then told her son the good news, the mother may have unlawfully tipped her son, breaching a duty to the pi – if there was a sufficient benefit to satisfy that element of a tipping claim. in any event, applying sec rule 10b5-2(b)(3), a trade by the son based on what his mother told him could be a violation of the misappropriation theory unless the son can show that the mother 199. the fda requires “return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated.” 21 c.f.r. § 312.59 (2017). northwestern’s irb has a comparable requirement. northwestern manual, supra note 79, at 35. there may be an exception if the drug is a providing benefit for the particular participant. then the sponsor may continue to provide it to the participant even if the trial is terminated as part of the protocol for termination of a trial. 200. see supra text accompanying notes 69-70 (regarding stock price movement as indicative of materiality). 201. see supra text accompanying note 42-46. 202. see infra text accompanying notes 229-34. 203. see supra text accompanying notes 18-30. 2023] insider trading in the clinical trial setting 235 did not expect her son to keep the information confidential.204 if these activities come to light, it might embarrass the institution, for having prematurely released some aspect of the trial results or allowed them to be discovered by a participant. though there might not be any institutional liability under the securities laws, the misconduct by its pi might tarnish its chances, or those of the pi who leaked, of becoming a site for further drug trials, or it could lose future funding or even have to repay funds already spent.205 potential institutional liability in this context has not been discussed in this article, and for good reason. the bar is very high for the sec to prevail on that claim. it is extremely unlikely that the institution, such as a medical school, would be charged as a direct participant in the trade which acted with scienter, such as engaging in insider trading in securities held by its endowment, unless the manager of the endowment knew the mnpi.206 section 21a of the exchange act provides for the imposition of a penalty on someone who directly or indirectly controlled the person who committed the insider trading violation.207 there are two barriers to sec success in asserting that claim against the institution. first, controlling person status here cannot be based solely on the fact that the controlling person, the medical school, employed the inside trader. more must be shown to establish control .208 second, the burden is 204. that rule provides that a duty of trust and confidence exists, whenever a person receives or obtains material nonpublic information from his or her spouse, parent, child, or sibling; provided, however, that the person receiving or obtaining the information may demonstrate that no duty of trust or confidence existed with respect to the information, by establishing that he or she neither knew nor reasonably should have known that the person who was the source of the information expected that the person would keep the information confidential, because of the parties’ history, pattern, or practice of sharing and maintaining confidences, and because there was no agreement or understanding to maintain the confidentiality of the information. 17 c.f.r. § 240.10b5-2(b)(3) (emphasis added). bear in mind, once again, that tippee lability and misappropriation liability on the part of the son who received the information in a relation of trust and confidence, as provided in rule 10b-5(b)(3), are distinct claims. see supra two paragraphs following text at end of note 49. 205. see 21 c.f.r. § 16 (“regulatory hearing before the food and drug administration”). for a summary of sanctions, see fda guidance document, clinical investigator regulatory sanctions information sheet (jan. 1998), https://www.fda.gov/regulatory-information/search-fdaguidance-documents/clinical-investigator-regulatory-sanctions-information-sheet. the fda explained the process for disqualification of investigators at clinical investigators disqualification proceedings. see, e.g., 21 c.f.r. § 312.70 (“disqualification of a clinical investigator”). 206. sec rule 10b5-1(c)(2) provides an affirmative defense for an entity that trades securities charged with insider trading if, among other things, the firm “implemented reasonable policies and procedures . . . to ensure that individuals making investment decisions would not violate the laws prohibiting trading on the basis of material nonpublic information. these policies and procedures may include those . . . that prevent such individuals from becoming aware of such information.” rule 10b5-1(c)(2)(ii), 17 c.f.r. § 240.10b5-1(c)(2)(ii). 207. exchange act section 21a(a)(1)(b), 15 u.s.c. § 78u-1(a)(1)(b). 208. exchange act section 21a(a)(2), 15 u.s.c. § 78u-1(a)(2). 236 indiana health law review [vol. 20:199 on the sec to prove that the “controlling person knew or recklessly disregarded the fact that such controlled person was likely to engage in the act or acts constituting the violation and failed to take appropriate steps to prevent such act or acts before they occurred.”209 the onerous nature of these conditions may explain why there are no decided cases assessing a penalty for control person liability outside the context of entities regulated by the sec, such as a brokerdealer.210 even if an institution concludes that there is nothing to fear here, however, the fact that the institution implemented the suggestions in part vii should cause the sec to think more than twice about asserting an institutional claim. entering into a confidentiality agreement presents a potential conundrum. if the sponsor or the research institution wants to minimize the risk of disclosure of mnpi, whether or not they are concerned about anyone’s unlawful trading, the prudent thing is to obtain a confidentiality agreement and highlighting it to the participant (where it might be one of many fine print provisions, say in the icf). doing so, however, makes the recipient of information vulnerable to violating rule 10b-5 if she were to trade, an exposure that might not exist but for that agreement. this may be seen as boxing in the recipient or, perhaps worse, setting the participant up for a problem were she to trade without fully appreciating the legal risk. is it appropriate for the sponsor or institution to place the participant it recruited at risk in that manner? c. risks of insider trading violation by government personnel persons other than pis, their teams, trial participants, and people they know who lawfully come into possession of mnpi about a clinical trial, most notably fda personnel, could be impacted by insider trading laws. fda employees as well as their spouse and minor children are prohibited from holding financial interests, like stock, in certain businesses regulated by fda. this includes many companies working in the drug, biologic, medical device, food, and tobacco industries, among others.”211 in one case, an fda chemist was charged with insider trading based on confidential information about at least 27 upcoming fda announcements of drug approval decisions, positive and negative, generating more than $3.6 million in illicit profits and avoided losses.212 the defendant was 209. exchange act section 21a(b)(1), 15 u.s.c. § 78u-1(b)(1). 210. in that context, the proceeding is commonly based on a failure by the broker to supervise. see, e.g., in the matter of sg americas securities, llc exchange act release no. 59,401, 95 sec docket 580 (feb. 13, 2009) (sanctioning firm and direct supervisor of employee for failure to supervise what was the other employee’s unlawful trading, including apparent insider trading). 211. fda, prohibited financial interests for fda employees, who are restricted from holding financial interest in sros? (july 22, 2020), https://www.fda.gov/about-fda/ethics/ prohibited-financial-interests-fda-employees [https://perma.cc/q83p-5n6k]. 212. sec litigation release, sec charges fda chemist with insider trading ahead of drug approval announcements, litig. rel. no 21,907 (mar. 29, 2011), https://www.sec.gov/ news/press/2011/2011-76.htm [https://perma.cc/j2z6-72nq]. the defendant settled the case. sec 2023] insider trading in the clinical trial setting 237 also indicted; he pleaded guilty and received a five-year sentence.213 there had been a question whether any of the doctrines of insider trading developed under rule 10b-5 applied to government employees. for example, did a government employee owe a duty of trust and confidence to anyone, so that the misappropriation theory could apply to his trading or tipping?214 in the complaint against the fda chemist just described, the sec alleged that the fda employee owed a duty of trust and confidence to the fda.215 congress sought to eliminate any ambiguity in this respect by enacting the stop trading on congressional knowledge (“stock”) act in 2012.216 in pertinent part, section 21a(h) of the exchange act, amended by the stock act, now provides that for purposes of rule 10b-5 each executive branch employee, each judicial officer, and each judicial employee owes a duty arising from a relationship of trust and confidence to the united states government and the citizens of the united states with respect to material, nonpublic information derived from such person’s position as an executive branch employee, judicial officer, or judicial employee or gained from the performance of such person’s official responsibilities.217 thus, information learned by an fda employee “derived from such person’s position as an executive branch employee” provides the predicate for a charge of insider trading. the potential targets of an enforcement action are many, with two principal theories supplemented by tipper-tippee liability, reaching the sponsor (and its insiders), the clinical trial team (not just someone designated a pi), and advisors to any of them, such as an investor advisor to the sponsor,218 a member of the litig. release, former fda chemist settles sec insider trading charges, litig. rel. no. 22, 171 (nov. 30, 2011), https://www.sec.gov/litigation/litreleases/2011/lr22171.htm [https://perma.cc/ jes8-gkuj]. 213. press release, doj, former fda chemist sentenced to 60 months in prison for insider trading (mar. 5, 2012), https://www.justice.gov/opa/pr/former-fda-chemist-sentenced-60-monthsprison-insider-trading [ https://perma.cc/7zjl-7nnr]. 214. see bainbridge l&p, supra note 1, at 110-12 (describing pre-stock act debate). 215. see supra notes 212-213; cmpl. at ¶¶ 46-56, sec v. liang, no. 8:11-cv-00819 (d. md. mar. 29, 2011), https://www.sec.gov/litigation/complaints/2011/comp21907.pdf [https://perma.cc/ 8khm-8bue] 216. stock act, pub. l. 112-105, 126 stat. 291., 112th cong. (2012). the background of the stock act is described at bainbridge l&p, supra note 1, at 109-13. 217. 15 u.s.c. § 78u-1(h). the stock act provides that nothing in the stock act “shall be construed to— (1) impair or limit the construction of the antifraud provisions of the securities laws . . . or (3) be in derogation of existing laws, regulations, or ethical obligations governing members of congress, employees of congress, executive branch employees, judicial officers, or judicial employees.” stock act, pub. l. 112-105, 126 stat. 291, 112th cong. (2012). an “executive branch employee,” as defined in 5 u.s.c. § 2015, includes an employee of the fda, part of the executive branch of the government. 218. see text accompanying notes 124 (citing case). 238 indiana health law review [vol. 20:199 sponsor’s advisory board,219 and government employees.220 d. other risks of violating rule 10b-5 not involving insider trading anyone with mnpi about a drug trial should not lose the forest of overall trial integrity for the insider trading tree. in particular, anything nonpublic that the participant learns from any source conducting the trial should not be publicly revealed by him because public revelation might compromise the trial.221 one paper recommended that “research teams should also talk to their study subjects about where and how they are obtaining information in order to prevent behaviors and correct misinformation that could put a subject’s safety or the study objectives at risk.”222 for these and other reasons, participants must be requested not to post clinical trial information on investor, disease-related, or drug-specific chatrooms.223 participants asked not to post on chatrooms may, however, perceive this as “a violation of their right to self-expression.”224 returning to securities law concerns, a person posting on a chatroom information he knows to be false, or posts recklessly, might violate rule 10b-5. this could have the characteristics of a classic “pump and dump scheme.” where insiders inflate demand for a stock by disseminating laudatory information about a company—information that is usually false. if the market reacts favorably, the insiders’ cash in their shares before the market readjusts and the share price collapses.”225 219. sec litig. release, sec charges pharma insider and two relatives with insider trading, litig. rel. no. 25, 458 (july 28, 2022), https://www.sec.gov/litigation/litreleases/ 2022/lr25458.htm [https://perma.cc/7h6u-wwxr]. (reporting complaint filed against member of advisory board of sponsor who allegedly tipped his brother who in turn tipped his son-in-law after he learned the fda “had concluded that the clinical study for [the sponsor’s] developmental drug . . . was not adequate and well-controlled,” and reporting that the initial tipper had settled the case). 220. see supra text accompanying notes 214-15 (citing case and discussing stock act). 221. see supra text accompanying note 185 (discussing power of irb to terminate trial). 222. glickman, supra note 117, at 71 (emphasis added). see also id. at 73-74, 77. 223. see examples of chatrooms or virtual communities are at healthful chat, https://www.healthfulchat.org/health-chat-rooms.html [https://perma.cc/lud3-tu8e] (last visited jan. 19, 2023); see also patient community forums, https://patient.info/forums [https://perma.cc/ 4qwy-g8n2] (last visited jan. 19, 2023) (providing list and links to disease-specific chatrooms); yahoo! finance, https://finance.yahoo.com/quote/gsk/community/ [https://perma.cc/9lgxrtc6] (last visited jan. 19, 2023); london south east, https://www.lse.co.uk/sharechat.asp?share ticker=gsk&share=glaxosmithkline [https://perma.cc/hv3q-a66b] (last visited jan. 19, 2023) (chatrooms regarding stock of pharmaceutical company glaxosmithkline plc); drugs-forum, https://drugs-forum.com/ [https://perma.cc/8prb-2atw] (last visited jan. 19, 2023) (chatroom regarding any drug). 224. glickman, supra note 187 at 78. 225. united states v. weed, 873 f.3d 68, 70 n.1 (1st cir. 2017), quoting garvey v. arkoosh, 354 f. supp. 2d 73, 76 n.4 (d. mass. 2005). 2023] insider trading in the clinical trial setting 239 the initial purchase of sponsor stock by someone involved in the clinical trial might be entirely innocent. if, however, negative information about the drug emerged during the trial and anyone knowing it then posted false favorable information on a chatroom to retard a decline in the price of that stock, he might be liable to public investors under rule 10b-5 on the price maintenance theory.226 if the participant later sold the stock before the company released the bad news, insider trading would become an issue.227 the practical point bears emphasis – one who buys stock may be locked in to retaining that stock once she learns mnpi that is unfavorable, if she is an insider or has a relationship of trust and confidence with the source of that information. the participant is frozen until the information becomes public or is no longer material. stock bought many years ago might have to be held for many more. c. what information about a clinical trial is material? materiality is often incontestable, for example where the stock price moves immediately and significantly after release of new information and nothing else is offered to account for that but the new information. the clinical trial insider trading case is one where the sec’s assertion of materiality could reasonably be contested, as where the price movement is not dramatic. if the information is not material there is no concern about anyone trading while aware of it. the fundamental question is whether the reasonable investor would find the information important in making an investment decision regarding the stock of the trial sponsor. because a clinical trial is an ongoing process, the probability/magnitude test could come into play as events ebb and flow.228 in many clinical trials, whether the drug succeeds or fails has a potentially dramatic impact on the company, satisfying the magnitude prong.229 to apply that materiality test a court or jury would also have to determine what the probability was, at the time of the securities transaction underlying the claim, that the trial was going to succeed or, in the mirror image, fail. material information could 226. posting false information to maintain the price when the participant has learned mnpi and wants to dump the stock before the truth becomes public, may violate rule 10b-5. under the inflation maintenance theory, “a misrepresentation causes a stock price ‘to remain inflated by preventing preexisting inflation from dissipating from the stock price.’” goldman sachs grp., inc. v. arkansas teacher retirement sys., 141 s. ct. 1951, 1959 (2021), quoting findwhat investor grp. v. findwhat.com, 658 f.3d 1282, 1315 (11th cir. 2011) (emphasis in findwhat). 227. the timing of when a company should disclose new material information is typically properly a matter of discretion for management of the company. in re time warner inc. sec. litig., 9 f.3d 259, 267 (2d cir. 1993) (“a corporation is not required to disclose a fact merely because a reasonable investor would very much like to know that fact. rather, an omission is actionable under the securities laws only when the corporation is subject to a duty to disclose the omitted facts.”) 228. see supra text accompanying notes 64-72. 229. see supra text accompanying note 70. the question is how significant to the company fda approval or disapproval would be. 240 indiana health law review [vol. 20:199 emerge at any stage of the process. this is an inherently fact-intensive question at every point, as the probability of a positive or negative outcome ebbs and flows. there is another materiality-related factor. the scienter, an intent to deceive necessary for liability, depends on what the alleged trader or tipper knew about the trial – facts – as there is liability only if the person knew or recklessly disregarded that the facts were material. this depends on what she knew.230 the information known to the participant – or what she thinks she knows – might be materially incomplete, she might be entirely wrong about what she thinks she knows. information about a single trial participant, such as herself, might not be material. she might misinterpret the information she thinks she knows – her perceived improvement of her own health or that of others in the trial might be the result of the placebo effect, providing no meaningful information about the efficacy of the drug. what she learns and observes about a few other participants might still not, in the aggregate, be material. the accuracy and materiality of what is known by the participant might depend on whether the trial is double blind, single blind, or open label at the time she trades. on the other hand, isolated instances of adverse effects that might be attributable to the drug could be material, as the court held in matrixx.231 a fact that may seem innocuous may be material. for example, financial institutions maintain a restricted list of companies in which company personnel are prohibited from trading. the list contains no information other than the name of the company whose stock is off limits. there is no explanation why the company is on the list.232 the single fact that a company is on the list, however, might pose insider trading concerns: the problem with the restricted list is that the simple fact of placement of a company on the list—which by definition will be available to a wide variety of persons within and without the firm—is then a signal that there is undisclosed material information about the particular issuer, which by itself might operate as a tip.233 demonstrating the level of detail that may come into play in making this determination, consider the putative class action where the court declined to dismiss the complaint where the plaintiff alleged there were materially incomplete disclosures regarding a phase iii trial. assessing materiality required an understanding of the particulars of an international trial. the court held that the plaintiff “sufficiently pleads that defendants’ statements characterizing their phase 3 trials as conducted in ‘europe’ were misleading” when the european trials were all conducted in “eastern europe.” “given that [plaintiff] alleges differences between eastern and western european patient populations and that the fda treats clinical data from those populations differently, defendants’ 230. see supra text accompanying notes 33-38. 231. see supra text accompanying notes 67-68. 232. langevoort insider trading, supra note 1, at § 12:3. 233. id. 2023] insider trading in the clinical trial setting 241 statements ‘create[d] an impression of a state of affairs that differ[ed] in a material way from the one that actually exist[ed].’”234 d. when does information about a clinical trial become public? rule 10b-5 is not violated if the trading is based on information that is public. a potential trader has no way to know when an event will occur that constitutes public revelation of material information – this raises questions of both fact and law.235 information can become public when it leaks236 or when it is posted to a chatroom. as noted earlier, if information can be found on the internet it is most likely public, but its absence from internet search results does not mean it is not public.237 there are several ways information about a trial is lawfully provided to a limited audience, where it is not a tip.238 information regarding ongoing clinical trials is presented at medical conferences. a major cancer conference had restricted participation; after repeated leaks, however, the proceedings and written presentations were opened to the public.239 many conferences, however, remain 234. pardi v. tricida, inc., no. 21-cv-00076-hsg, 2022 wl 3018144, at *5 (n.d. cal. july 29, 2022) (quoting brody v. transitional hosps. corp., 280 f.3d 997, 1006 (9th cir. 2002)). 235. the sponsor in kosinski issued a press release announcing the hold on any further activity in the trial. see press release, sec, regado biosciences announces clinical hold of regulate-pci trial following voluntary halt of trial by regado, exhibit 99.1 to form 8-k of regado biosciences, inc. (july 9, 2014), https://www.sec.gov/archives/edgar/data/1311596/00011931 2514264453/d755202dex991.htm [https://perma.cc/gh36-xut4]. 236. see adam feuerstein & matthew herper, early peek at data on gilead coronavirus drug suggests patients are responding to treatment, stat (apr. 16, 2020), https://www. statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-areresponding-to-treatment/ [https://perma.cc/snw4-4all] (reporting on preliminary clinical trial results, based on comments made by pi within the past week “during a video discussion about the trial results with other university of chicago faculty members. the discussion was recorded, and stat obtained a copy of the video.”). 237. see supra text accompanying note 63 (discussing libera). libera remains the touchstone. see, e.g., sec v. mayhew, 121 f.3d 44, 50 (2d cir. 1997) (applying libera in determining information on which defendant traded was nonpublic). 238. sec regulation fd (17 c.f.r. pt. 243) requires a public company to make simultaneous or prompt public disclosure when a “senior official” of the company makes a private disclosure to anyone in certain categories of persons, such as a securities research analyst. the nonpublic disclosures discussed in this article would not likely trigger a disclosure obligation under regulation fd. 239. the american society of clinical oncology (asco) holds an annual conference. there was an “asco effect” where stock prices of companies whose clinical trial results were going to be revealed there “would often go up or down based on early word on results that were sent to about 25,000 people 2 weeks ahead of time so people could plan what sessions they wanted to attend at the meeting.” merrill goozner, stocks’ study renews concerns over insider trading on oncology drugs, 103 natl. cancer inst. 1652, 1655 (2011). asco now publishes abstracts 242 indiana health law review [vol. 20:199 closed.240 whether or not the presentation is open to the general public, attendees could carry a phone, tablet, or even a laptop as they roam the conference rooms, in order to place a trade in the stock of a trial sponsor based on what is revealed there, before the press could even blog about the previously undisclosed information. whether this event constitutes public disclosure is an open question, likely to depend on the specifics of the event, such as who was invited. registrants are generally not required to sign any confidentiality or nondisclosure agreement to attend or to access materials (often posted online before the conference opens). for example, the terms and conditions for a september 2022 program sponsored by the national comprehensive cancer network imposed only a very limited restriction on the use of information provided at the program.241 attendees are not insiders, nor temporary insiders. there is no relationship of trust and confidence that would preclude trading. under these circumstances the attendee is likely free to trade, she need not wait to trade once the information is disclosed to a broader audience. there may be internal presentations at the institution conducting the trial, such as during grand rounds at a hospital, where personnel who are not part of the clinical trial team learn about the status of the trial before any “broad, nonexclusionary distribution” of the information.242 disclosure to a large number of persons, especially where – as here – there is typically no express pledge of confidentiality, could be deemed to be public disclosure, even if the event is limited to employees of the institution. developments in a clinical trial are often first disclosed intentionally in a when they are sent to participants. id. currently the conference is essentially open to the public. 2023 asco annual meeting, https://conferences.asco.org/am/attend [https://perma.cc/dv8q5nnp] (last visited jan. 19, 2023). 240. see, e.g., per, 21st annual international congress on the future of breast cancer® east, https://event.gotoper.com/event/7f23d043-df27-42c6-92ab-609355ae164a/summary?utm_ medium=paid&utm_source=google&utm_campaign=ibc_east&utm_term=awareness_breast&u tm_content=_&gclid=cjwkcajw7vuubhbueiwaedu2plnwl4hjik5xcrzihkwq1ygx8dqj 3pshrnjjmm-591fue6rlvz82abocsdyqavd_bwe [https://perma.cc/3fag-hkkh] (regarding 2022 meeting) (last visited jan. 19, 2023). a non-systematic internet search reveals that many conferences are now open to non-professionals, presumably including trial participants, though often at a very high fee to attend. webcasting makes it more feasible for non-professionals to attend. 241. see nccn, event terms and conditions, ¶ 1.4 (“by registering for nccn 2023 congress, you agree not to sell, trade, transfer, or share your access link and/or onsite meeting badge, unless such transfer is granted by the organizer.”); ¶ 1.7 (no part of the nccn 2023 congress, including handout materials and slides, may be recorded, rebroadcasted, reproduced, or transmitted in any other form or by any means, electronic or mechanical, without first obtaining written permission from nccn, participants are permitted to print a copy of handouts for personal use only.”), https://web.cvent.com/event/98f8aeb9-2328-420b-9d38-7f0e08509127/websitepage: 9e1112b4-3248-4591-9060-202baee45470 [https://perma.cc/fkx6-h4el] (last visited jan. 19, 2023). 242. see supra text accompanying note 62 (quoting regulation fd). 2023] insider trading in the clinical trial setting 243 medical journal.243 publication is typically preceded by a “preprint” of the article before publication in a journal. [a] preprint is defined as a complete written description of a body of scientific work that has yet to be published in a journal. typically, a preprint is a research article, editorial, review, etc. that is ready to be submitted to a journal for peer review or is under review.244 in one case, an author of a paper traded in advance of the publication of the article, using his knowledge of the impending publication to time his trade.245 reviewers of a preprint may sign a confidentiality agreement or are subject to the publication’s peer review confidentiality policy.246 breaching that agreement and trading is misappropriation, not trading on a tip.247 the sponsor might give journalists with special knowledge in the field an advance look at trial results, so that when public disclosure is made, such as through a press release by the sponsor, the reporters will be able to publish a prompt, informed, not spur-of-the-moment, analysis. typically, the contents revealed to the journalist are subject to an embargo, a time-limited confidentiality agreement. the policy of the new england journal of medicine, for example, states that it “employs a media embargo system, which allows journalists time to conduct interviews in the days before an article’s publication.”248 this journalistic practice presents two potential opportunities for unlawful 243. see, e.g., supra note 235 (noting publication of early-stage trial results in a medical journal). 244. philip e. bourne et al., ten simple rules to consider regarding preprint submission, 13 plos comput. biol. 13(5) (2017), https://doi.org/10.1371/journal.pcbi.1005473 [https://perma. cc/t3gs-4h92]. 245. sec litigation release, sec v. changnian liu, litig. rel. no. 15,783 (june 17, 1998), https://www.sec.gov/litigation/litreleases/lr15783.txt [https://perma.cc/rt56-hm2t] (reporting that the lead author of paper about drug under study settled case in which sec alleged he traded before the article was published when he knew the article was to be published in a few days). 246. see, e.g., nature, editorial policies – confidentiality, https://www.nature.com/natureportfolio/editorial-policies/confidentiality#:~:text=editors%2c%20authors%20and% 20reviewers%20are,of%20reviewers%20are%20not%20released [https://perma.cc/4d8e-pecn] (“unless otherwise declared as a part of open peer review, the peer review process is confidential and conducted anonymously; identities of reviewers are not released. reviewers must maintain confidentiality of manuscripts. . . nature portfolio reserves the right to contact funders, regulatory bodies, journals and the authors’ institutions in cases of suspected research or publishing misconduct.”) (last visited jan. 19, 2023); the lancet, peer review, https://www.thelancet. com/peer-review (last visited jan. 19, 2023). (“authors share their work with editors on the principle of confidentiality and the expectation that editors and peer reviewers will not circulate the manuscript outside of the peer review process.”). 247. see supra second paragraph of text following note 49. 248. the new england j. of med., editorial policies embargo, https://www.nejm.org/aboutnejm/editorial-policies [https://perma.cc/h5cd-b98t] (last visited jan. 19, 2023). earlier practices were discussed in m. waldholz & e. wyatt, stock traders get early look at drug studies, wall st. j. (feb. 18, 1988), https://www.sec.gov/news/press-release/2021-94 [https://perma.cc/2f8wujef]. 244 indiana health law review [vol. 20:199 trading. if the journalist accepted the early look under a pledge of confidentiality and then traded based on the information, he is exposed under the misappropriation theory because the journalist breached a duty of confidentiality. a leading case involved persons who obtained and the traded and tipped based on advance information about upcoming market-moving columns in the wall street journal.249 the author of some of the columns tipped information about the contents of forthcoming columns by himself and others to stockbrokers. the second circuit found it clear that [the columnist], as an employee of the wall street journal, breached a duty of confidentiality to his employer by misappropriating from the journal confidential prepublication information, regarding the timing and content of certain newspaper columns, about which he learned in the course of his employment, which sufficed to establish a violation of rule 10b-5 in connection with the subsequent trading.250 there are many ways in which clinical trial results may become public, other than by a conventional press release, inclusion in an sec disclosure document (which often attaches a press release as an exhibit), or in a scientific journal. in all cases it is critical to determine when nonpublic information becomes public, as well as whether it is material. this involves the exercise of informed legal judgment, often at one’s peril. assume that an insider learns that clinical trial mnpi is about to be made public, as in a press release or sec filing. is it lawful for that insider, sitting at his computer logged into his brokerage account, having completed all of the terms of his order, to click on “place order” as soon as someone else presses “send” to release the news in a way that is “reasonably designed to provide broad, nonexclusionary distribution of the information to the public.”251 the best practice is to wait until the investment professionals whose trading sets the market price have had some time, however short, to factor in this information, so that the individual trading does not benefit from knowing the inside information as to both the facts to be disclosed and the timing of disclosure.252 249. united states v. carpenter, 791 f.2d 1024 (2d cir. 1986) (affirming convictions, including under rule 10b-5 applying a version of the misappropriation theory before the definitive ruling in o’hagan), aff’d by equally divided court on rule 10b-5 claim, 484 u.s. 19 (1987) (affirming convictions for mail and wire fraud). 250. carpenter, 791 f.2d at 1029, 1034. 251. see supra text accompanying note 62 (quoting regulation fd). 252. see bainbridge l&p, supra note 1, at 68-70 (stating it is permissible to trade once “the price should have started rising or falling (as the case may be) to reflect the new information”). see also, supra text accompanying note 63, describing the libera test for when information becomes public. this may happen very fast, if the market is driven by algorithmic trading enhanced by artificial intelligence, factoring the content of new information into the process. “whereas initial algorithmic trading relied on preset electronic instructions to execute trading strategies, new technology is introducing artificially intelligent (‘ai’) trading algorithms that learn dynamically from data and respond intuitively to market changes.” gine-fail s. fletcher, deterring algorithmic manipulation, 74 vand. l. rev. 259, 259 (2021); cox, supra note 72, at 97 (describing algorithmic trading as occurring in milliseconds or microseconds, based on a variety of data, including news 2023] insider trading in the clinical trial setting 245 e. summary of types of insider trading claims that might arise in clinical trial setting this article has identified several quite plausible situations where someone involved in or privy to information about a clinical trial might run afoul of the rule 10b-5 prohibition on insider trading or otherwise violate rule 10b-5. they include: trading by an insider, including a temporary insider, of the trial sponsor, aware of mnpi about the company, including mnpi about the sponsor’s clinical trial, but also, in some circumstances, a pending acquisition by or of the company or other material event. trading by a participant in the trial if she knows or discerns, from nonpublic sources, mnpi regarding the trial – but only if the information was obtained from one or more persons with whom the participant has a relationship of trust and confidence. depending on the circumstances – development of a practice of sharing confidences or entering into a confidentiality agreement, which need not be a formal document – the misappropriation theory may apply. limited but arguably unrestricted disclosure, such as at a medical gathering, even before more conventional disclosure such as a press release, may make the information public, so that those who have the benefit of early information may trade. tipping mnpi regarding a trial. this includes tips by an insider of the sponsor, anyone on the trial team at the investigating institution, and – at least in theory – a participant in the trial. the tip is unlawful only if the arguable tipper could not himself have traded because to do so would have violated the classical or misappropriation theory. providing information to a journalist to give her an advance look at trial information to facilitate informed publication, where providing early information might take on the trappings of a tip by that member of the trial team, though not if the investigator’s sole purpose in disclosing was to facilitate accurate reporting. being deceived into revealing mnpi about the trial. while the person deceived by the wrongdoer would not ordinarily violate the law, that person could become enmeshed in a proceeding against the person who engaged in the deception. a member of the trial team or a participant intentionally or recklessly posting arguable mnpi regarding the trial on any chatroom, all the more so if it is false. in considering the consequences of trading in the stock of a trial sponsor, or a company “economically linked” to it, any entity or individual must bear in mind the consequences of becoming involved in an sec investigation, even if no proceeding is ultimately filed by the sec. a securities law violation or other misuse of mnpi might compromise the trial itself, because of conflict-of-interest issues on the part of those who traded, such as the pi. reports and social media). 246 indiana health law review [vol. 20:199 vii. recommendations for prophylactic action many steps should be taken in connection with clinical trials, including those routinely implemented in the for-profit corporate world, to reduce the risk of unlawful conduct, or even of embarrassment and reputational harm that can arise if an investigation ensues. any entity, including a for-profit trial sponsor and a not-for-profit institution conducting the trial, should have written policies prohibiting insider trading, typically more broadly defined than the law reaches today, signed by each appropriate person (erring on the side of inclusion) and re-affirmed periodically. insider trading policies must be updated to reflect developments in the law. one example is including the “shadow trading” theory in the entity’s insider trading policy if only to demonstrate how unpredictably broad the law may be.253 corporate insider trading policies are sometimes filed with the sec as exhibits to a variety of company reports or are otherwise made public by the company. some are better than others, and anyone contemplating using one as a model should bear in mind that they are tailored for the circumstances of the particular company or institution. some of the most important components are noted here, by no means everything that should or might be included in the policy for a pharmaceutical company or institution that conducts trials. the steps suggested here should extend to all employees involved in trials who have access to nonpublic information about the trial.254 there should be periodic training explaining generally the law of insider trading and the prohibition on trading when aware of mnpi about a drug or the sponsor of a drug trial, with ample time for questions and answers.255 what reason could there be not to do this training from time to time, save the time it takes to train every so often and the potential legal fees in connection with the presentation? training could include requiring viewing of a video, where those who must watch it cannot fast-forward or click on “next” to avoid watching or listening to the content. live training could be done under the aegis of a professional organization or group of institutions to reduce the cost for a single institution. considering this approach must consider whether the participating entities have different written policies, and that confidential information might be revealed during the typical question and answer session. the pledge of confidentiality should be required of anyone arguably a temporary insider – to the extent that they can be identified, such as temporary staff hired to do data entry – and of anyone who might learn material information 253. see supra text accompanying notes 128-29 (discussing shadow theory as addressed in panuwat). 254. training and policies that are signed should extend to some persons who are not directly involved in the trial, including senior administrative personnel, such as the dean of a medical school, who might learn mnpi in their general oversight role. 255. this explanation of the law need not, indeed should not, be of the scope presented in this article. the typical description, which often errs on the side of over-designation of what is prohibited may be just a few pages. 2023] insider trading in the clinical trial setting 247 about an ongoing trial, including during a chat over coffee with a colleague not involved in the trial or during an organized internal presentation. the fda form 1572 requires disclosure to the sponsor of certain financial interests of the pi, including others involved in the trial.256 the best practice is to absolutely prohibit any trading in the stock of a company, including any derivatives whose value depends on the price of the sponsor’s stock, by any person involved in any way in the conduct of a clinical trial sponsored or otherwise supported by that company or institution.257 when the trial results in publication, any conflict of interest must be disclosed by the authors.258 someone who fails to comply with financial disclosure requirements and traded while aware of mnpi might thereby compound his rule 10b-5 violation.259 one step, analyzed earlier, is to obtain a signed confidentiality agreement from the pi and the staff involved, and possibly trial participants, as early in the process as possible, even if none is signed by a participant until after the icf is signed. alternatively, or in addition, the entire investigation team and the trial participants should agree, in writing, not to trade, or at the very least, at a bare minimum be admonished not to trade. limits should be imposed on participants telling others about how the trial appears to be going, such as informing family members without running the risk of someone misappropriating mnpi told to them in confidence by the participant.260 to be sure, in the case of the trial participant these are substantial concerns only if the information they know, or perhaps deduce, is mnpi – unless they spread false information, which of course they should be admonished in no uncertain terms not to do. it would be best if participants did not share information among themselves about how they are doing vis-à-vis the purpose of the trial. while that information may provide a false impression of the effects of the drug, the more one knows about the apparent response of others the more likely one might create a meaningful mosaic of information that could actually be material, posing a risk that any trading or further disclosure could be unlawful. 256. 21 c.f.r. pt. 54. disclosures are required of the spouse and each dependent child of the investigator and sub-investigator. 21 c.f.r. pts. 54.2(d), 54.4. the fda has provided guidance on financial disclosures in guidance for clinical investigators, industry, and fda staff financial disclosure by clinical investigators (feb. 2013), https://www.fda.gov/media/85293/download [ https://perma.cc/mxb6-cgln]. the recommendations regarding what financial information is to be provided when submitting a marketing application include disclosing “any equity interest in any sponsor of the covered clinical study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices. id. p. 4, item b.3. 257. here consider the fda’s strict policy prohibiting ownership of any stock of a trial sponsor, among others. see supra text accompanying note 211 (discussing fda policy). 258. see, e.g., jeffrey m. drazen et al., toward more uniform conflict disclosures — the updated icmje conflict of interest reporting form, 363 n. eng. j. med. 188 (july 8, 2010) (discussing conflict of interest disclosures in medical publications). 259. see kosinski, 976 f.3d at 147. 260. see supra note 204 (discussing rule 10b5-2(b)(3)). 248 indiana health law review [vol. 20:199 this suggests that some effort should be made to isolate information about each participant from each other – though likely a fool’s errand. if there is no confidentiality agreement with the participant, participants should be given scripted, low key but clear, cautions about what information they can reveal (and what they should not) and to whom they can reveal it if the need arises, explaining that a disclosure could undermine the trial, lead to termination of the trial because it has been compromised in some way, or have other adverse repercussions. they should be told that early termination of the trial might adversely affect their disease population, such as when termination of the trial or of their participation would mean that the drug can no longer be evaluated, at least as part of the current trial. at the extreme, though likely impractical, measures could be taken to avoid consecutive or overlapping treatment appointments or to isolate participants if the trial entails coming to a hospital for a treatment or tests. this would be comparable to measures taken in the financial services world to separate (a) those doing research on issuers of securities or trading for the account of the firm from (b) those who provide services to those same companies, such as investment or commercial banking, where they invariably learn client mnpi.261 the institution should direct trial participants not to post any information about any aspect of the trial on a chatroom and to reveal information only to persons who have a need to know. best to have an agreement to that effect. this might seem unduly cautious. nevertheless, better to be conservative to avoid any possible compromise of the trial. the participant ought to be able to respond in general terms to a social or community acquaintance who simply wants to know how the person is doing. the inquirer may know of the person’s malady but not that she is in a trial or what the drug is. the participant should be told he can discuss the fact of the trial if it comes up but not reveal the name of the drug or manufacturer unless her participation in this trial has been disclosed. these instructions and admonitions should be written, providing a copy to each participant, and they should be told to retain it. one measure to consider, which in the corporate world is often applied only to more senior personnel, is to require prior approval of any trade – purchase or sale – in the securities of an issuer. this requires a robust approval process, which means that the approving person must have real-time access to information sufficient to determine whether there is mnpi which might require rejection of the request.262 if there is such a policy, there must be a prohibition on revealing 261. see sec rule 10b5-1(c)(2), quoted supra note 206. 262. this practice is not fool proof. a senior attorney at apple who was privy to draft financial disclosures and responsible for monitoring compliance with the company’s insider trading policy, pleaded guilty to a charge of insider trading. press release, united states attorney’s office for the district of new jersey, apple’s former director of corporate law admits insider trading (june 30, 2022), https://www.justice.gov/usao-nj/pr/apple-s-former-director-corporate-law-admitsinsider-trading#:~:text=gene%20levoff%2c%2048%2c%20of%20san,by%20complaint% 20in%20february%202019 [https://perma.cc/4sgn-jp3l]. in one sec case, the defendant claimed that a trade was approved by the company’s general 2023] insider trading in the clinical trial setting 249 that a request was declined, as it may imply the presence of mnpi in a specific direction.263 given the practical difficulties of implementing some of these steps, trading in the sponsor’s stock by anyone involved in the trial should be prohibited for the duration of the trial, including selling a pre-existing holding. for example, an investigator may purchase stock of a pharmaceutical company with which he has no current involvement, basing his purchase entirely on public information. later he becomes a pi for that company’s trial. if he learns mnpi about that company, such as clinical trial data, he may – he is likely to be – constrained from trading for a long time. this restriction could last for years, as more mnpi is learned; often there is no point at which all material information has been made public because new information may be developed on an ongoing basis. viii. conclusion the clinical trial setting can present temptations to engage in insider trading for anyone on the research team. trial participants might experience the same urge. many persons – corporate executives, medical professionals, and other team members – have given in to the temptation, with regrettable results. even though the sec has not brought cases based on some of the theories posited in this article, the risk is there, with little or no broadening of existing law. medical and other scientific professionals, as well as the institutions that employ them, and clinical trial participants should be aware of these risks and take the relatively benign steps recommended here to prevent or at least deter violations. the easiest, best answer, as always, is – when in doubt, don’t trade or tip. no case is too small for the sec and the consequences can be dire. counsel, in accordance with company policy. sec v. adler, 137 f.3d at 1329. “when [the general counsel was] asked why he interposed no objection when told of [defendant’s] proposed sale, and whether he believed [defendant] possessed material nonpublic information at the time, [the general counsel, also a member of the board] stated that he ‘really did not think of it in those terms.’” id. at 1329 n.7. 263. see ari b. lanin & daniela l. stolman, building a better insider trading compliance program, 25 insights (no. 3) 1, 6 (mar. 2011), https://www.gibsondunn.com/wp-content/ uploads/documents/publications/lanin-stolman-buildingabetterinsidertradingcompliance program.pdf [https://perma.cc/9gtt-wmnn]. 250 indiana health law review [vol. 20:199 appendix no. filing date venue s = sec c = court i = also indicted name of first def; total number sued url for sec release or pleading (complaint or order instituting proceedings) disposition s = settled sf = settled when filed 1 7/28/22 klein/3 https://www.sec. gov/litigation/litr eleases/2022/lr25 458.htm sf one defendant 2 7/7/22 s sweeney/1 https://www.sec. gov/litigation/ad min/2022/3311079.pdf sf 3 6/27/22 s spector/1 https://www.sec. gov/litigation/ad min/2022/3311078.pdf sf 4 12/20/21 c, i catenacci/1 https://www.sec. gov/litigation/litr eleases/2021/lr25 291.htm pleaded guilty 5 12/2/21 c, i malik/2 https://www.sec. gov/news/pressrelease/2021-249 wood pleaded guilty https://www.justi ce.gov/usaonj/pr/formerhead-corporatecommunications21-billionbiopharmaceutic al-companyadmits-insider 6 9/17/21 c, i mallu/1 https://www.sec. gov/news/pressrelease/2021-181 sf pleaded guilty 7 6/7/21 c calice/2 https://www.sec. gov/news/pressrelease/2021-94 sf 2023] insider trading in the clinical trial setting 251 8 7/21/20 s leung/1 https://www.sec. gov/enforce/3489352-s sf 9 12/20/19 c, i wang (songjiuang) /1 https://www.sec. gov/litigation/litr eleases/2019/lr24 697.htm convicted, aff’d us v. chan 981 f.3d 39 (1st cir. 2021) s (https://www.sec. gov/litigation/litr eleases/2021/lr25 122.htm) 10 12/20/19 c, i chan/1 https://www.sec. gov/litigation/litr eleases/2019/lr24 697.htm convicted, aff’d us v. chan 981 f.3d 39 (1st cir. 2021) summary judgment granted to sec (https://www.sec. gov/litigation/litr eleases/2021/lr25 122.htm) 11 2/21/19 c vacante/1 https://www.sec. gov/litigation/litr eleases/2019/lr24 406.htm sf 12 8/8/18 c, i collins/3 https://www.sec. gov/litigation/litr eleases/2018/lr24 231.htm all three pleaded guilty s later (https://www.sec. gov/litigation/litr eleases/2019/lr24 687.htm) 13 8/16/18 s wang (hongian)/1 https://www.sec. gov/litigation/ad min/2018/3483857.pdf sf 252 indiana health law review [vol. 20:199 14 7/10/18 c shen/1 https://www.sec. gov/litigation/litr eleases/2018/lr24 194.htm sf 15 12/7/17 c leonard/1 https://www.sec. gov/litigation/litr eleases/2017/lr24 005.htm sf 16 9/21/17 s zingerman/1 sf 17 6/27/17 c, i alvater/3 3 separate complaints alvater indicted https://www.sec. gov/litigation/litr eleases/2017/lr23 868.htm alvater convicted two defendants sf this defendant settled later (https://www.sec. gov/litigation/litr eleases/2020/lr24 855.htm) 18 12/16/16 s myers/2 https://www.sec. gov/litigation/litr eleases/2017/lr24 005.htm sf 19 9/29/16 c, i gadimian/1 https://www.sec. gov/litigation/litr eleases/2016/lr23 662.htm pleaded guilty settled with sec after pleading guilty (https://www.sec. gov/litigation/litr eleases/2018/lr24 217.htm 2023] insider trading in the clinical trial setting 253 20 8/14/16 c, i kosinski/1 https://www.sec. gov/litigation/litr eleases/2016/lr23 611.htm conviction aff’d 976 f.3d 135 (2d cir. 2020) s (https://www.sec. gov/litigation/litr eleases/2021/lr25 077.htm) 21 6/15/16 c valvani/2 https://www.sec. gov/news/pressre lease/2016119.html case abandoned against valvani who had died johnston settled after filing (https://www.sec. gov/litigation/litr eleases/2016/lr23 688.htm) 22 6/9/15 c, i fefferman/3 https://www.sec. gov/litigation/litr eleases/2015/lr23 279.htm sf as to all three wiegand and eracleous pleaded guilty, 23 7/10/15 s boudreault https://www.sec. gov/litigation/ad min/2015/339864.pdf sf 24 8/216/14 c, i lucarelli https://www.sec. gov/news/pressrelease/2014-175 s https://www.sec. gov/news/pressrelease/2014-175 pleaded guilty 254 indiana health law review [vol. 20:199 25 5/19/14 c chu/2 https://www.sec. gov/litigation/litr eleases/2011/lr22 057.htm sf 26 4/21/14 c itri/2 https://www.sec. gov/news/pressrelease/2014-80 sf 27 11/20/12 c, i martoma/3 https://www.sec. gov/litigation/litr eleases/2012/lr22 539.htm sf – gilman (https://www.sec. gov/litigation/litr eleases/2012/lr22 539.htm) conviction of martoma aff’d 894 f.3d 64 (2d cir. 2017) s martoma (https://www.sec. gov/litigation/litr eleases/2021/lr25 022.htm) s funds (https://www.sec. gov/litigation/litr eleases/2013/lr22 647.htm) 2023] insider trading in the clinical trial setting 255 28 9/27/12 c, i lee/1 https://www.sec. gov/news/pressrelease/20122012-201htm s https://www.sec. gov/files/judg12cv-05031lee.pdf https://www.sec. gov/files/judg12cv05031chen.pdf pleaded guilty https://www.sec. gov/litigation/litr eleases/2013/lr22 678.htm https://www.sec. gov/litigation/litr eleases/2013/lr22 758.htm how our buildings shape us: an argument against pl 180’s preemption of local government control over green building codes in indiana hope rice* i. introduction “we shape our buildings; thereafter our buildings shape us.” – winston churchill1 as our climate changes, our building practices must also change. conventionally built infrastructure will deteriorate as natural disasters become more prevalent and severe. additionally, built environments contribute to the worsening effects of climate change by generating over 40% of annual global carbon dioxide emissions.2 implementation of green building codes, which consider durability and sustainability in the materials, design, and components of construction, can lower the environmental impact from conventional buildings while creating resilience and protection from the effects of climate change. in 2021, the indiana general assembly added public law 180 (pl 180) to indiana’s home rule statute, historically a statute which grants broad power for self-government to local communities. instead, pl 180 preempts local indiana governments at the state level, prohibiting them from requiring that their built environments be constructed with any energy-saving or -producing designs, components, or materials.3 additionally, pl 180 reinforces indiana’s dependence on fossil fuel powered energy sources and delays our inevitable shift to renewable energy production, causing higher utility bills for hoosiers and maintaining vulnerability to power outages. rumored to be enacted for the benefit of gas and construction companies, pl 180 unnecessarily takes power from local indiana governments to protect residents from the effects of climate change that are forecasted to become severely destructive in our near future.4 * j.d. candidate, 2024, iu robert h. mckinney school of law; b.a. art history, 2017, university of cincinnati. 1. churchill and the commons chamber, uk parliament, https://www.parliament. uk/about/living-heritage/building/palace/architecture/palacestructure/churchill/#:~:text=churchill% 20insisted%20that%20the%20shape [https://perma.cc/me7z-jqcf] (last visited mar. 1, 2023). 2. why the built environment?, architecture 2030, https://architecture2030.org/why-thebuilding-sector/ [https://perma.cc/xs4q-26m5] (last visited mar. 9, 2023). 3. ind. code § 36-1-3-13 (2021). 4. enrique saenz, new law restricts local government’s ability to address climate change, ind. env’t rep. (may 5, 2021), https://www.indianaenvironmentalreporter.org/posts/newlaw-restricts-local-governments-ability-to-address-climate-change#:~:text=public% 2 0 law%20 18 0 %2 c%2 0as%20hb,b ased %2 0 o n %2 0 th e%2 0 en ergy%20 so u rce . [https://perma.cc/7fs7-p5h2]; see also indiana’s past and future climate: a report from the indiana climate change impacts assessment, purdue univ. 1 (mar. 1, 2018), https://docs.lib. purdue.edu/cgi/viewcontent.cgi?article=1000&context=climatetr [https://perma.cc/pmn9-myr4]. 200 indiana health law review [vol. 21:199 after the house of commons chamber was destroyed by bombing in world war ii, winston churchill advocated for the chamber to be rebuilt in an adversarial rectangular shape which encouraged debate between members of the house and caused them to “seriously weigh their commitments” before they crossed the floor.5 churchill insisted that the shape of the chamber should reflect strength and trust in their democratic system.6 he believed that the chamber was more than just a structure; the chamber symbolized human trust and resilience. similarly, hoosiers should be able to trust that their built environment can provide durable shelter and protection in the face of severe storms, flooding, and other natural disasters. hoosiers should also be able to trust that the indiana general assembly is acting in their best economic and environmental interest, not the financial interest of gas and construction companies. while many local indiana governments have climate action plans that will add more protections for their residents in the face of climate change, pl 180 restricts local indiana governments from reaching their full potential to create trust and resilience in their built environments and protect hoosier’s physical, financial, and environmental health. this note argues that pl 180 works against the historical purpose of building codes to protect the public, causes indiana communities to be more vulnerable to the effects of climate change, and makes an empty promise of municipal selfgovernment through indiana’s home rule statute. first, this note provides a brief historical background of american building codes and the current american trend to embrace green buildings codes or prohibit them through state preemption. next, this note discusses influence from utility and construction companies that induced the passage of pl 180 as well as the economic benefits that pl 180 provides to the law’s primary author. this note then analyzes pl 180 as a burdensome policy to the economic and environmental health of hoosiers and indiana communities and asserts that pl 180 works against the historical purpose of home rule. finally, this note argues that the indiana general assembly must repeal pl 180 or limit it through a sunset clause, and then considers a possible challenge to pl 180 through the privileges and immunities clause of the indiana constitution to restore constituent’s faith in our general assembly’s commitment to legislate on behalf of hoosiers’ concerns and not those of gas and construction companies. 5. russel smith, winston churchill on how our buildings shape us, russell’s inspiration daybook (apr. 24, 2018), https://inspirationdaybook.wordpress.com/2018/04/24/ winston-churchill-on-how-our-buildings-shape-us/ [https://perma.cc/3e6e-ksu9]. see also churchill and the commons chamber, supra note 1. 6. mark petock, more than structures? we are creating environments of trust., automated bldg. (aug. 2020), http://automatedbuildings.com/news/aug20/articles/lynxspring/ 200721102909lynxspring.html [https://perma.cc/l7m9-cuf3]. 2024] how our buildings shape us 201 ii. background a. what makes a building code “green”? building codes reflect society’s expectation that our built environment should be safe for use and habitation.7 building codes are laws that set minimum requirements for the design and construction of structural systems, heating and air conditioning, ventilation, electrical and natural gas systems, and other aspects of commercial buildings and residences.8 the first building codes appeared in the code of hammurabi.9 one code stated that if a “builder builds a house for someone, and does not construct it properly, and the house falls in and kills its owner, then that builder shall be put to death.”10 in the united states, devastating events like natural disasters and major fires influenced the adoption of building codes first by individual cities.11 after the great chicago fire of 1871, the chicago city council mandated the use of fire-resistant building materials, like brick and terra cotta, and banned the use of wood as a building material from the downtown chicago area.12 the 1906 san francisco earthquake caused legislators to consider seismic effects and implement earthquake engineering design in building codes.13 new york city mandated sprinkler systems and fire extinguishers in buildings after the 1911 triangle shirtwaist factory fire took hundreds of workers’ lives.14 building codes evolved to protect the public after environmental disasters devastated built environments and destroyed thousands of lives and vast amounts of property. 7. elizabeth a. cocke, building codes: the role they can play, u.s. dept. of hous. & urb. dev. (feb. 20, 2018), https://www.huduser.gov/portal/pdredge/pdr-edge-frm-asst-sec022018.html [https://perma.cc/2al8-8btt]. 8. understanding building codes, nat’l inst. of standards & dev. (june 16, 2022), https://www.nist.gov/buildings-construction/understanding-building-codes [https://perma.cc/j49ld5bv]. 9. eugene j. heady, construction law – the history is ancient!, smith currie, https://www.smithcurrie.com/publications/common-sense-contract-law/construction-law-thehistory-is-ancient/pdf/#:~:text=hammurabi's%20code%20was%20one%20of,shall%20be% 20put%20to%20death [https://perma.cc/a7kv-wznm] (last visited feb. 25, 2023). 10. id. 11. jim rossberg & roberto t. leon, evolution of codes in the usa, nat’l earthquakes prevention program 2-3, https://www.nehrp.gov/pdf/ujnr_2013_rossberg_manuscript.pdf [https://perma.cc/9dap-dh29] (last visited feb. 15, 2023). 12. blair kamin, city learned lessons from its catastrophes, chi. tribune (apr. 28, 1992), https://www.chicagotribune.com/news/ct-xpm-1992-04-28-9202070670-story.html [https://perma.cc/dw8g-8rnd]. 13. evolution of codes, stan. univ., https://quake06.stanford.edu/centennial/tour/stop10. html [https://perma.cc/c79c-n2v7] (last visited feb. 15, 2023). 14. u.s. census bureau history: the triangle shirtwaist fire of 1911, u.s. census bureau (mar. 2016), https://www.census.gov/history/www/homepage_archive/2016/march_2016.html [https://perma.cc/9m7y-6wwk]. 202 indiana health law review [vol. 21:199 american state and local governments mostly control building codes.15 the federal government does not set standards for state and local building codes, except for manufactured homes.16 many states adopt statewide building codes but leave adoption of their code to the discretion of individual cities, counties, and townships.17 consequently, many large cities follow their own building code, while rural areas of a state sometimes do not adopt any building codes.18 state and local governments model their building codes from regional “model codes” developed by two private organizations: the international code council and the national fire protection association.19 building code development was historically outsourced to private organizations because of the “fundamental belief” that the private sector can produce better standards, more efficiently, than the government.20 the private organizations that write conventional building codes do not consider the environmental impact from construction or the built environment.21 conversely, green building codes consider public safety from an additional perspective: structural resiliency that protects inhabitants from the effects of climate change.22 green building refers to both the structure and construction processes that are environmentally responsible and resource efficient in the design, construction, operation, maintenance, and deconstruction of a building.23 green buildings improve upon conventional building materials’ 15. understanding building codes, supra note 8. 16. the u.s. department of housing and urban development (hud) sets building standards for manufactured housing which preempt state and local building codes. manufactured homes are built in a factory and transported in one or more sections to a plot of land. for more on hud’s manufactured home construction and safety standards, see proposed updates to the manufactured home construction and safety standards, u.s. dept. of hous. & urb. dev., https://www.hud.gov/omhp#:~:text=hud's%20manufactured%20housing%20program%20is, and%20administration%20of%20dispute%20resolution [https://perma.cc/cgs6-c7qf] (last visited feb. 15, 2023). 17. rossberg & leon, supra note 11. 18. id. 19. cocke, supra note 7. 20. rossberg & leon, supra note 11. 21. alexander c. kaufman, cities voted for green building codes. now developers want to end voting., grist (mar. 1, 2021), https://grist.org/politics/minneapolis-building-codes-industrybacklash/ [https://perma.cc/2tqt-yzev]. 22. see green building standards, u.s. env’t prot. agency, https://www.epa.gov/ smartgrowth/green-building-standards#:~:text=buildings%20(ashrae% 20189.1),a%20model%20code%20that%20contains%20minimum%20requirements%20for% 20increasing%20the,and%20modular%20and%20mobile%20homes [https://perma.cc/lqj8mtne]; see also green building codes, standards, and rating systems, bldg. with chemistry https://www.buildingwithchemistry.org/building-future/green-building-codes-standards-ratingsystems/ [https://perma.cc/gk8p-lcqw] (last visited feb. 1, 2023). 23. green building, basic information, u.s. env’t prot. agency (feb. 20, 2016), https://archive.epa.gov/greenbuilding/web/html/about.html [https://perma.cc/yul7-s3z9]. 2024] how our buildings shape us 203 environmental impact by instead using sustainably manufactured materials.24 green building materials are often made from reutilized materials like recycled plastic, reclaimed wood, or recycled steel.25 some green buildings use natural materials like bamboo, straw, sheep’s wool insulation, “hempcrete” (a concretelike material made from hemp fibers), or “timbercrete” (a mix of sawdust and concrete).26 green buildings also consider resource conservation through devices like high-efficiency plumbing fixtures and water-efficient irrigation technologies.27 energy efficiency is a cornerstone of green building.28 green buildings use energy efficient appliances that use less power to accomplish the same task as a competing appliance.29 for example, smart thermostats are an energy efficient alternative to manual thermostats because they connect to the internet and read weather forecasts to self-adjust indoor temperatures.30 tankless water heaters instantaneously provide hot water only as needed instead of tank water heaters that constantly use energy to keep gallons of water warm at all times.31 thicker insulation helps to cut utility bills by 50% and significantly reduces carbon dioxide emissions from buildings.32 some green buildings even cover uninsulated roofs with living plants, which can save up to 5% of heating energy in the winter and 33% of cooling energy in the summer.33 24. joseph g. allen et al., green buildings and health, 2 current env’t health rep. 250 (july 10, 2015), https://link.springer.com/article/10.1007/s40572-015-0063-y#citeas [https://perma. cc/v46f-cmwu]. 25. id. 26. id. 27. how to increase water efficiency in green buildings?, one energy sys., https://www. 1energysystems.com/water-efficiency-in-green-building/#:~:text=the%20core% 20concepts%20of%20green,avoiding%20wastage%20of%20natural%20resources [https://perma.cc/h2u6-5y48] (last visited feb. 1, 2023). 28. emily rabin, durability: a key component of green building, greenbiz (dec. 18, 2005), https://www.greenbiz.com/article/durability-key-component-green-building [https://perma.cc/yt2s-lpcx]. 29. jane marsh, the top energy efficient appliances, env’t (july 11, 2022), https://environment.co/the-top-energy-efficient-appliances/ [https://perma.cc/vmg9-y853]. 30. id. 31. tankless water heaters v. storage tank water heaters, grainger (feb. 17, 2022). https://www.grainger.com/know-how/equipment-information/kh-tankless-vs-storage-tank-waterheaters?gucid=n:n:ps:paid:ggl:csm-2296:ad9mjx:20511231&gclid=eaiaiqob chmik5ak7rmx_qiv8ciucr2fuw0jeaayasaaeglzsfd_bwe&gclsrc=aw.ds [https://perma.cc/7rtv-al35]. 32. karen carstens, size and thickness do matter, say housing-insulation makers, politico (may 27, 2003), https://www.politico.eu/article/size-and-thickness-do-matter-say-housinginsulation-makers-2/ [https://perma.cc/3l9a-3l66]. 33. 17+ sustainable and green building construction materials, conserve energy future, https://www.conserve-energy-future.com/sustainable-construction-materials.php [https://perma.cc/n49m-abp4] (last visited feb. 1, 2023). 204 indiana health law review [vol. 21:199 durability is another cornerstone of green buildings because they must withstand the effects of climate change.34 extreme temperatures, strong storms, flooding and other intense weather events cause conventional building materials to deteriorate, but green building materials are manufactured to withstand these events with minimal damage.35 green buildings consider durability in the siting of new buildings, so that they are built outside of floodplains and away from coastlines.36 green buildings consider internal moisture management, implementing exhaust systems where the most significant moisture sources are located, like kitchens and bathrooms.37 other durability considerations in the construction or retrofitting of buildings are thermal stressors which can cause building materials to contract and expand, degradation from ultraviolet rays, insect damage, and life cycle analyses of building materials so that builders can be sure they are using materials that do not wear out as quickly as competing materials.38 conventional building materials can negatively affect human health, while green buildings consider the effect of pollution and toxins on humans from building materials. many conventional building materials contain chemicals which can lead to shortand long-term adverse health effects.39 conventional materials like concrete and certain types of paints and varnishes contaminate the environment and can cause illness because of the human and environmental consumption from their mining, extraction, production, treatment, transport, and installation processes.40 indoor air quality is especially affected by volatile organic compounds emitted from building materials, which have an adverse effect on the health of humans, especially humans that spend a lot of time indoors, like students and office workers.41 short-term effects are skin allergies, eye irritation, throat irritation, or sneezing, while long term effects can manifest as asthma, cancer, or infertility.42 some of these effects can even pass to the next generation in the form of autism, obesity, or hormonal disorders.43 green buildings that use 34. rabin, supra note 28. 35. id. 36. id. 37. id. 38. id. 39. partisha laskar, importance of building materials on human health, linkedin (aug. 23, 2020), linkedin.com/pulse/importance-building-materials-human-health-pratisha-laskar/?utm_ medium=website&utm_source=archdaily.com [https://perma.cc/4hec-abxt]. 40. non-polluting construction materials, sustainability for all, https://www. activesustainability.com/construction-and-urban-development/non-polluting-constructionmaterials/?_adin=02021864894) [https://perma.cc/a3c6-dy4x] (last visited feb. 1, 2023. 41. mateusz kozicki & adam nieslochowski, materials contamination and indoor air pollution caused by tar products and fungicidal impregnations: intervention research in 20142019, nat’l libr. of med. (july 23, 2020), https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc7435637/ [https://perma.cc/sf9y-p8rh]. 42. laskar, supra note 39. 43. id. 2024] how our buildings shape us 205 natural and sustainable materials can decrease or eliminate the negative health effects to humans caused by conventional building materials. additionally, studies show that buildings which incorporate green infrastructure like green roofs, ornamental living walls, or a surrounding landscape with trees or living plants have positive effects on human health.44 people that live or work near areas with a higher concentration of green roofs have better mental health, heal more quickly after an illness, and are more productive at work.45 australian hospitals with interior and exterior living plant infrastructure reported reduced hospital stays by 8.5%, increased recovery time by 15%, and lowered need for pain medication by 22%.46 living plant infrastructure in buildings also improves indoor air quality, which is one of the top five environmental risks to human health.47 green building codes complement and expand the conventional building concerns of economy, utility, durability, and comfort.48 while conventional and green buildings share a primary goal of public safety, green buildings consider additional layers of public safety: the protection of humans and the natural environment from pollution caused by buildings, within the broader context of how the built environment can protect humans from the worsening effects of climate change. by requiring durable, healthy, and sustainable materials, designs, and components, green building codes provide long-lasting benefits to human and environmental health. b. what is happening with green building codes throughout the united states? building codes are an increasingly popular area of legal interest to gas and construction companies.49 gas companies losing profits through the transition to energy efficient homes and an increasing use of renewable energy sources are influencing state legislators to pass state preemption laws which preclude local governments from restricting the use of gas-powered appliances.50 similarly, construction companies are lobbying state legislators to preempt building code control at the state level so that local governments cannot require environmentally conscious building practices, which can require more expensive materials and 44. sazan rahman, green buildings can reduce temperatures by up to 2c, study shows, world econ. f. (feb. 17, 2022), https://www.weforum.org/agenda/2022/02/green-buildings-canboost-productivity-well-being-and-health-of-workers [https://perma.cc/39c3-m429]. 45. id. 46. id. 47. id. 48. green building, basic information, supra note 23. 49. see kaufman, supra note 21; rebecca leber, an “attack on american cities” is freezing climate action in its tracks, vox, (sep. 29, 2021), https://www.vox.com/22691755/gasutilities-fight-electrification-preemption [https://perma.cc/w4sh-7stq]. 50. id. 206 indiana health law review [vol. 21:199 specialized training for builders.51 the state of arizona passed a building code preemption law in 2020.52 after california’s calgreen legislation, nearby natural gas companies noticed the fiscal impact from lower usage rates of natural gas.53 influenced by southwest natural gas and it’s political action committees’ campaign donations, arizona senate president, karen fann, and speaker of the house, rusty bowers, introduced a bill that prohibited local governments from enacting building codes that would favor electricity over natural gas.54 their bill became law even though no arizona cities or towns had even attempted to pass a local law requiring that any structures adhere to any sort of green building code at that time.55 additional states that have similarly passed building code preemption laws from the influence of gas and construction companies are texas, oklahoma, kansas, and tennessee, while fourteen other states are considering preemption bans.56 nevertheless, the city of scottsdale, arizona created a voluntary green building program designed to reduce the environmental impact of buildings.57 scottsdale’s green building program works around the state’s building code preemption statute because it is voluntary; the city did not set green building code requirements. the city of scottsdale gives cooperating builders the green building program logo to display in their structures because the city believes that the logo will strengthen cooperating companies’ environmental image. the city acknowledges that modern home buyers are more “savvy and demanding” when selecting environmentally conscious home products.58 scottsdale’s voluntary program does not conflict with arizona’s state preemption statute but provides a pathway for environmentally conscious builders to follow. some states follow an opposite path by codifying green building codes. the state of california adopted the first and most robust statewide green building code in the united states in 2009.59 the california green building standards code, or calgreen, works to improve public health, safety, and general welfare through design and construction of residential and non-residential buildings.60 51. id. 52. joan fitzgerald, preemption of green cities in red states, planetizan (sept. 7, 2021), h t tps : / /www.planet izen .com/b logs/114584-preemption-green-ci t ies-red-states [https://perma.cc/k3wz-d6qg]. 53. id. 54. id. 55. id. 56. id. 57. invitation to participate, city of scottsdale, https://www.scottsdaleaz.gov/greenbuilding-program/invitation [https://perma.cc/7knm-7ndb] (last visited mar. 1, 2023). 58. id. 59. california green building standards code, tit. 24, part 11 (2022, act effective jan. 1, 2023). 60. calgreen, cal. dep’t of hous. & dev., https://www.hcd.ca.gov/building-standards/ calgreen#:~:text=calgreen%20is%20california's%20first%20green,california%20code%20o f%20regulations%20%e2%80%8c [https://perma.cc/3fvf-qstp] (last visited mar. 1, 2023). 2024] how our buildings shape us 207 calgreen does not preclude local california governments from enacting stricter green building regulations, however, by 2010, at least fifty california local governments did so.61 california’s goal is to encourage positive environmental impact and sustainable construction practices through five categories: planning and design, energy efficiency, water efficiency and conservation, material conservation and resource efficiency, and environmental quality.62 calgreen involves mandatory and voluntary practices for all buildings constructed after january 1, 2011, with provisions for both newly constructed buildings and alterations for existing buildings.63 additional states that have codified green building codes or standards are colorado,64 virginia, washington, and oregon.65 states are divided over the issue of building codes and how much control their local governments should have to enact their own building requirements. further, interference from utility and construction companies has caused building codes throughout states to become a “battleground.”66 indiana is one such battleground state. iii. legislative background and analysis of pl180, how pl 180’s policy has a negative impact on indiana communities, and possible legal solutions pl 180 was enacted in 2021 and added to indiana’s home rule statute.67 pl 180 provides that local units may not: (a) require that new buildings be constructed, or existing buildings be retrofitted, with a particular component, design, or type of material because that component, design, or material has energy-saving or energy-producing qualities; (b) prohibit the use of a particular component, design, or type of 61. andrea ward, california adopted nation’s first statewide green building code, architectural rec., (feb. 9, 2010), https://www.architecturalrecord.com/articles/5407california-adopts-nation-s-first-statewide-green-building-code [https://perma.cc/lvw8-pzhn]. 62. calgreen, supra note 54. 63. id. 64. calvin hennick, regulatory wins for green buildings in three u.s. states, u.s. green bldg. council (feb. 11, 2021), https://www.usgbc.org/articles/regulatory-wins-green-buildingthree-us-states [https://perma.cc/dv3z-s77g]; colorado has adopted green building standards, not green building codes. building standards are voluntary requirements typically written in technical language for architects and builders, while building codes are law. see green building codes, standards, and rating systems, supra note 21. 65. hennick, supra note 63; see also green codes and initiatives, bldg. innovations database, https://www.buildinginnovations.org/green-codes-initiatives/ [https://perma.cc/95uf6vqm] (last visited mar. 14, 2023). 66. david iaconangelo, building codes: the new natural gas battlefront?, energy wire (may 3, 2022), https://www.eenews.net/articles/building-codes-the-new-natural-gas-battlefront/ [https://perma.cc/5w8s-dqc4]. 67. ind. code § 36-1-3-13 (2021). 208 indiana health law review [vol. 21:199 material in the construction of a building because the component, design, or material does not meet an energy saving standard; (c) prohibit or restrict the purchase or use of vehicles or other machines based upon the type of energy that powers it;68 (d) prohibit the sale, installation, or use of natural-gas powered home heating equipment and home or outdoor appliances; or (e) enact codes, ordinances, or land use regulations that would stop utilities from selling, or customers from purchasing, liquid petroleum gas or other fuel based on the energy source.69 pl 180 has wide-ranging subject matter, combining restrictions on building materials, designs, and components based on their energy-saving or -producing capabilities, restriction to prohibit natural gas powered appliances, restriction of vehicle sales based on their power source, and restriction of local land use ordinances based on the ability of customers to purchase or utilities to sell liquid petroleum gas.70 construction materials, vehicles, home appliances, and land use ordinances seem disconnected to be joined in one law; the connecting factor is that their sale, use, or installation is limited based on what kind of energy they use. more specifically, the law prohibits the sale, use, or installation of these components only if local governments work to require that they have energysaving qualities. this note focuses on pl 180’s construction limitations but finds that home appliances and land use ordinances conveniently work into an overall preclusion of green building codes. the passage of pl 180 was supported by country mark, indiana/michigan power, the indiana energy association, the indiana manufacturer’s association, and the indiana builder’s association.71 the law was also supported by the indiana chamber of commerce, whose members use, trade, and invest in fossil fuels.72 further, the indiana environmental reporter has conjectured that the law was supported by members of the american legislative exchange council (alec), a nonprofit organization that joins state legislators with experienced drafters, which can include lobbyists.73 critics point to alec’s boilerplate language, present in pl 180, that has also turned up in energy and building code 68. part (c) prohibits local governments from requiring that vehicles used or purchased in their jurisdiction have any energy saving attributes. for example, a local government cannot require that car dealerships in their jurisdiction only sell electric vehicles. the transportation sector accounted for 27% of u.s. greenhouse gas emissions in 2020, exceeding the electric power sector’s emissions by 2%. however, the transportation sector is outside the scope of this note. see daniel a. farber & cinnamon p. carlarne, climate change l. 148, 291 (foundation press, 2nd ed. 2023). 69. see ind. code § 36-1-3-13 (2021); see also saenz, supra note 4 (saenz paraphrases pl 180 in an easy-to-read way in which it is displayed in this note but is not the full text in the indiana code). 70. ind. code § 36-1-3-13 (2021). 71. saenz, supra note 4. 72. id. 73. id. 2024] how our buildings shape us 209 preemption laws at the influence of alec in kansas, missouri, west virginia, and several other states.74 rep. jim pressel, the primary author of the law, framed pl 180 as a shortterm measure to aid hoosiers during the covid-19 pandemic: “i think it’s very unfair to our constituents . . . to take away any source of energy that is . . . during a pandemic, the cheapest and most affordable way to heat your house.”75 while pressel describes the law as a pandemic protection, many pandemic protections were temporary and ended when federal funding ceased or the state ended its public health emergency status,76 unlike pl 180, a law that will be codified as indiana law unless it is repealed by the legislature or successfully challenged in court. pressel’s reasoning may be more self-serving than a measure to help hoosiers during a pandemic–pressel was the president of the indiana home builder’s association in 2016, and is also a current member of the board of directors for a high school program regarding building trades.77 further, rep. pressel owns a construction business which primarily builds new residential homes and remodels old residential homes in northwest indiana.78 conveniently for rep. pressel, pl 180 precludes local indiana governments from requiring that his business should construct or remodel homes according to any green building codes. pl 180 is not a law to help hoosiers during a pandemic; pl 180 is a law that insulates construction companies, like rep. pressel’s, from changing their building techniques or bearing extra expense to use environmentally conscious building materials, designs, and components. further, at the behest of local utility companies, pl 180 reinforces hoosiers’ dependence on fossil fuels as well as the 74. id.; see also kari lydersen, indiana lawmakers to vote on bill to ban local heating electrification initiatives, energy news network (jan. 25, 2021), https://energynews.us/ 2021/01/25/indiana-lawmakers-to-vote-on-bill-to-ban-local-heating-electrification-initiatives/ [https://perma.cc/qr38-qy9e]. 75. id. 76. the state of indiana ended its public health emergency status resulting from the covid-19 pandemic on march 3, 2022. see brandon smith, gov. holcomb officially ends indiana’s covid19 public health emergency, wfyi (mar. 3, 2022), https://www.wfyi.org/news/articles/gov-ericholcomb-officially-ends-indianas-covid-19-public-health-emergency [https://perma.cc/bjf5-a8j4]. during the covid-19 pandemic, many hoosiers were eligible to receive temporary emergency resources, such as rental assistance and additional snap benefits. the indy rent program stopped taking applications in 2022 when federal funding ended; see indyrent assistance portal, city of indianapolis, https://indyrent.org/ [https://perma.cc/j8cn-9an6] (last visited feb.19, 2023). additional snap benefits given during the covid-19 pandemic ceased when the state ended its public health emergency status. see snap benefits – covid-19 pandemic and beyond, u.s. dept of agric. (oct. 8, 2021), https://www.fns.usda.gov/snap/benefit-changes-2021#:~:text=30%2c% 202021.,permanently%20adjusted%20as%20of%20oct [https://perma.cc/vnh7-zywt]. 77. jim pressel, ind. house of rep. republican caucus, https://www.indianahouse republicans.com/members/general/jim-pressel) [https://perma.cc/y37r-lte6] (last visited mar. 15, 2023). 78. id. 210 indiana health law review [vol. 21:199 money hoosiers give to gas companies through the payment of their energy bills. rep. pressel’s purported consideration for hoosier’s energy costs is merely cover for the protection of his own construction interests as well as the gas companies that influenced passage of the law. a. pl 180’s impact on indiana communities there is a misconception that hoosiers are not concerned about the effects of climate change.79 in a survey of about twelve hundred hoosiers across the state, indiana university found that over 80% of rural and urban residents believe that climate change is happening to some degree.80 the environment ranks third out of the top four priorities for hoosiers, after education and health care, respectively.81 because hoosiers are concerned about the effects of climate change in their communities, many local governments have enacted climate action plans (with assistance from indiana university’s environmental resilience institute), which describe specific strategies that communities will take to reduce their local greenhouse gas (ghg) emissions and adapt to climate change.82 in richmond, indiana, over 80% of respondents to richmond’s climate action survey expressed concern about climate change and its future effects.83 richmond’s climate action plan associates five symbols attributed to certain provisions described as “co-benefits,” beneficial side effects of pursuing a particular adaptation or mitigation strategy.84 some co-benefits consist of a “nature co-benefit” which improves the natural environment, an “economic cobenefit” which could manifest as cost savings or significant revenues, and a “health co-benefit” which could reduce or avert negative health effects, like 79. molly burhans et al., how do rural hoosiers view climate change? insights towards engagement and policy design, ind. univ. env’t resilience inst. (2022), https://eri.iu.edu/toolsand-resources/hoosier-life-survey/hls-rural-report-text-alternative.html [https://perma.cc/j6fezy4q]. 80. id. 81. david daugherty et al., attitudes and opinions about environmental issues in indiana, ariz. state univ. morrison inst. for pub. pol’y (may 2020), https://www.ninapulliamtrust. org/wp-content/uploads/2020/09/website-pulliam-indy-enviro-survey-report-2020-5-15-20201.pdf [https://perma.cc/2nvm-ces3]. 82. other local units with climate action plans include bloomington, fort wayne, carmel, indianapolis, elkhart, evansville, gary, goshen, zionsville, and west lafayette. jonathan hines, indiana cities to develop climate action plans in partnership with iu, ind. univ. (mar. 9, 2020), https://news.iu.edu/stories/2020/03/iu/releases/09-indiana-cities-reduce-greenhouse-gasesresilience-cohort.html [https://perma.cc/eaf7-u7xs]. 83. city of richmond, indiana climate action plan, res. 9-2022, 2 (aug. 31, 2022) https://portal.laserfiche.com/portal/docview.aspx?id=166377&repo=r-979ae874&preview= zzbka7b [https://perma.cc/2tyt-geh2]. 84. id. at 9. 2024] how our buildings shape us 211 improved air quality or decreased heat stress.85 the first approach to richmond’s plan is to adapt their built environment.86 richmond asks: “[h]ow can we strengthen infrastructure knowing that extreme temperatures and precipitation can be destructive to concrete, pavement, and other commonly used construction materials?”87 their strategies to address this problem include implementing programs that reduce heat impacts on buildings and adopting policies for post-flood repairs to damaged infrastructure.88 richmond also plans to evaluate how their local business community will be affected by increasing costs to recover from extreme weather events and higher insurance rates.89 pl 180 precludes richmond from requiring that homes and local businesses build or retrofit their buildings with green building materials; as a result, richmond will continue to mitigate destructive climate events, spending local tax dollars on these issues in perpetuity, instead of being able to require green building codes which would provide a long-lasting foundation of protection and economic savings. richmond’s plan also contains a provision for increasing renewable energy sources in their local energy portfolio and integrating renewable energy into land use and zoning codes.90 notably, richmond’s plan “encourage[s] alternative energy generation,” 91 but pl 180 precludes richmond from requiring alternative energy generation, storage, and distribution. pl 180 also precludes richmond from adopting any land use ordinances which would stop utilities from selling, or customers from purchasing, liquid petroleum gas as their energy source instead of requiring the use of renewable energy.92 richmond’s climate action plan and projected co-benefits will never reach their full potential for protection, economic savings, and health benefits if richmond cannot fully implement their mitigation and adaptation strategies. instead, richmond and other indiana communities will exist in a constant state of trying to mitigate and recover, rather than providing meaningful and reliable resilience to their built environments and residents through green building codes. pl 180 unnecessarily stymies indiana local governments’ plans to fight climate change through environmentally conscious construction and energy production. consequently, indiana communities’ plans to create resilience for their residents will never be fully realized and communities will never be able to provide the full protection they seek and which climate change commands. sadly, pl 180 disincentivizes local indiana governments from enacting climate change mitigation and adaptation efforts and sends a broader message that their state legislators are not on their side and may even preempt any climate action efforts 85. id. 86. id. at 2. 87. id. at 12. 88. id. at 20-21. 89. id. at 23. 90. id. at 3. 91. id. (emphasis added). 92. ind. code § 36-1-3-13 (2021). 212 indiana health law review [vol. 21:199 they attempt to implement. most egregiously, pl 180 is a misuse of power by our legislators who will not act on constituents’ concerns about the effects our state faces from climate change, and instead use their ability to create law to their own advantage at the environmental and economic detriment of hoosiers and indiana communities. b. pl 180 is a burden to indiana communities’ environmental health pl 180 maintains the status quo for indiana’s current environmental health rankings: indiana has the forty-sixth worst natural environment and forty-sixth worst air quality in the united states.93 indiana has the highest carbon footprint in the industrial midwest94 and ranks eighth in the top ten states which emit the highest levels of ghg emissions.95 indiana has already been impacted by climate change through effects like heavy rainfall, extreme heat waves, and increasing disease-spreading insect populations like mosquitos.96 by 2050, the number of extremely hot days will significantly increase in every indiana county.97 these issues are forecast to become worse as ghg emissions rise.98 while conventional buildings contribute to over 40% of national ghg emissions, green buildings can reduce emissions significantly.99 a 2014 uc berkeley study found that buildings constructed to leadership in energy and environmental design (leed) standards reduced their emissions by 50% due to efficient water consumption, 48% through reduced solid waste generation, and 5% from reduced transportation.100 when buildings use less water, the emissions which result from the energy used to withdraw, treat and pump the water are reduced.101 recycled and sustainably manufactured building materials cause less solid waste to end up in landfills, and reduced transportation of materials and solid waste to and from buildings lowers emissions from fuel consumption.102 indiana communities are denied a crucial opportunity to provide protection 93. emily hopkins, indiana has a pollution reputation. here’s how bad it is., indianapolis star (apr. 24, 2018), https://www.indystar.com/story/news/2018/04/19/how-badindianas-environment-actually-according/525003002/ [https://perma.cc/44rn-p8s9]. 94. saenz, supra note 4. 95. sarah bowman, scrub hub: how much of the u.s. carbon emissions come from indiana? (hint: it’s a lot), indianapolis star (sept. 7, 2021), https://www.indystar.com/story/ news/environment/2021/09/07/indiana-carbon-emissions-ranking-among-highest-us/5683729001/ [https://perma.cc/m2g7-pkcm]. 96. burhans et al., supra note 79. 97. see indiana’s past and future climate, supra note 4, at 3-4. 98. id. 99. christina huynh, how green buildings can help fight climate change, u.s. green bldg. council (mar. 1, 2021), https://www.usgbc.org/articles/how-green-buildings-can-helpfight-climate-change [https://perma.cc/bs6q-t9dl]. 100. id. 101. id. 102. id. https://www.usgbc.org/articles/how-green-buildings-can-help-fight-climate-change https://www.usgbc.org/articles/how-green-buildings-can-help-fight-climate-change 2024] how our buildings shape us 213 and longevity to their environments without the ability to require a reduction in ghg emissions from their local built environments through green building codes. as our global climate rapidly and severely warms, state and local government initiatives can make a significant collective difference in the reduction of ghg emissions: “[t]he truth is that despite the large-scale, global impact of climate change . . . states and cities, not washington d.c. . . . have most of the legal powers to prevent warming. . . .”103 pl 180 precludes local indiana governments from facilitating their powerful role in protecting our local, state, and global climate. instead, pl 180 reinforces our current trajectory towards an uninhabitable climate by bolstering indiana’s astonishing rate of ghg emissions through usage of conventional construction practices.104 additionally, pl 180 reinforces indiana’s dependence on fossil fuel powered energy sources, historically an industry which has emitted the most ghg emissions than any other sector.105 gabriel fillipelli, executive director of indiana university’s environmental resilience institute, said that pl 180 “delays the really critical inevitability of switching over to renewable, non-climate destructive energy sources.”106 our climate will never heal if we do not “dramatically” change how we generate and use electricity.107 indiana communities must make this switch to renewable energy as natural resources become scarcer and more expensive,108 and ghg emissions from fossil fuel 103. bill ritter, why states and cities must lead the way on climate change, wall st. j. (apr. 26, 2016), https://www.wsj.com/articles/bl-258b-6941 [https://perma.cc/6tkj-klvm]. 104. a u.n. report published on mar. 20, 2023 reveals that “nations will need to make an immediate and drastic shift away from fossil fuels to prevent the planet from overheating dangerously . . . .”; brad plumer, world has less than a decade to stop catastrophic warming, u.n. panel says, n.y. times (mar. 21, 2023), https://www.nytimes.com/2023/03/20/climate/ global-warming-ipcc-earth.html [https://perma.cc/ge8x-99g5]. 105. the energy sector has historically been the largest emitter of ghg emissions, though the transportation sector’s ghg emission surpassed the energy sector’s by 2% in 2020. see farber & carlarne, supra note 68. 106. saenz, supra note 4. 107. importance of renewable energy in the fight against climate change, world wildlife fund (2015), https://www.worldwildlife.org/magazine/issues/summer-2015/articles/ importance-of-renewable-energy-in-the-fight-against-climate-change--3 [https://perma.cc/8fve9lce]. 108. see energy prices expected to stay at historic highs through 2023, enbridge (july 27, 2022), https://www.enbridge.com/projects-and-infrastructure/public-awareness/line-5newsroom/energy-prices-expected-to-stay-at-historic-highs-through-2023 [https://perma.cc/wr2nj8p7]; heath knakmuhs, inflation and resource scarcity drove electricity rates higher in 2021, u.s. chamber com. glob. energy inst. (april 12, 2022), https://www.globalenergyinstitute. org/inflation-and-resource-scarcity-drove-electricity-rates-higher-2021 [https://perma.cc/x2wkjzka]. utility prices have also been affected by the russia/ukraine war. see suriya jayanti, think the energy crisis is bad? wait until next winter, time (oct. 31, 2022), https://time.com/6226587/ energy-crisis-next-winter/ [https://perma.cc/6sbw-92d2]. 214 indiana health law review [vol. 21:199 powered energy sources create untenable emissions levels.109 however, pl 180 keeps indiana communities from shifting to renewable energy sources, delaying our ability to become familiar and comfortable with renewable energy technologies and maintaining indiana’s significant contribution to global ghg emissions levels through fossil fuel powered energy sources. finally, pl 180 sets a discouraging tone for indiana communities to effect meaningful changes to lower their environmental impact. pl 180 sends a message to local indiana governments that they can expect their environmental efforts to be preempted by the state, especially when those efforts affect major corporations with close ties to indiana legislators. unlike scottsdale’s green building logo, which the city believes will encourage interest in environmental consciousness, pl 180 precludes local governments from increasing visibility of environmental conservation through requirement of green building practices. hoosiers know the truth is that our climate is dangerously changing, and we will be affected by catastrophic climate effects soon,110 but our legislature continuously denies opportunities to enact law or policy that reflect constituents’ climate concerns.111 indeed, pl 180 demonstrates that our legislators actively work against their constituent’s concerns about climate change. c. pl 180 is a burden to hoosiers’ and indiana communities’ economic health pl 180 acts as an economic security for rep. pressel’s home building business and gas and construction companies at increasing, long-term costs to indiana residents and communities. pl 180 will cause hoosiers to pay more for energy and building maintenance costs as natural resources become more scarce and conventional building materials deteriorate.112 pl 180 also precludes hoosier’s properties from reaching their full property value potential since resilient homes boast higher values.113 finally, pl 180 precludes local governments from attracting environmentally conscious businesses, an expense borne by indiana residents and community economic development. green buildings are an important financial investment for hoosier home and 109. farber & carlarne, supra note 68. 110. hines, supra note 82. 111. the indiana general assembly has denied many environmental actions supported by hoosiers. see karl schneider, youth-driven bill to create climate task force dies in senate — again, indianapolis star (feb. 27, 2023), https://www.indystar.com/story/news/2023/02/27/ indiana-cl imate-change-task-force-bil l -gets-hearing-but-no-vote/69927018007/ [https://perma.cc/6k4k-bbhs]; sarah bowman & karl schneider, these bills seek to protect the environment and hoosiers’ health. they die every year., indianapolis star (jan. 30, 2023), https://www.indystar.com/story/news/environment/2023/01/30/indiana-general-assembly-ignoresenvironment-public-health-bills-year-after-year/69833407007/ [https://perma.cc/kd26-ye3d]. 112. knakmuhs, supra note 108. 113. alice c. hill & leonardo martinez-diaz, building a resilient tomorrow 23, 213 (oxford university press, 2020). 2024] how our buildings shape us 215 business owners and indiana communities.114 while green building materials can command higher prices in the building process, they provide significant longterm financial savings.115 green building materials are more expensive than conventional building materials because they may be less readily available and construction may take longer and require specialized knowledge to work with green technologies and materials.116 however, the cost of green building materials is lowering as competition in the market and interest in green building grows.117 one study found that a structure built to achieve basic leed certification costs only 0.8% more to build than a conventional building.118 importantly, green buildings create significant long-term savings for hoosiers and local governments through energy efficiency and lower maintenance costs which offset higher upfront costs. mit technology review predicts that energy demands for cooling will triple by 2050.119 increased energy usage in indiana homes and businesses will result in higher utility bills. in a 2020 survey, almost 30% of indiana households go without food or medicine to pay their utility bill.120 these households also received at least one disconnection notice or will keep their home at “unhealthy” temperatures to keep their utility bills low.121 energy efficiency is a critical part of green building design that lowers residents’ utility bills. pl 180 disincentivizes energy efficiency: real estate developers are likely to install cheaper-for-them, less energy efficient appliances without a requirement to install environmentally conscious building components. this issue is precisely why local communities must be able to require green building codes. otherwise, builders will choose materials, designs, and components that seem easier and less expensive for them to work with, at the long-term expense of hoosiers. since green buildings are more durable than conventional buildings, they 114. marc karell, saving green: the financial benefits of green buildings, fm link (dec. 2019), https://www.fmlink.com/articles/saving-green-financial-benefits-green-buildings/#:~: text=reduced%20costs.&text=many%20green%20updates%20prove%20to,cost%20savings% 20year%20after%20year [https://perma.cc/rkw8-gfzh]. 115. green buildings: what are green buildings?, pac. nw. nat’l lab’y, https://www.pnnl. gov/explainer-articles/green-buildings#:~:text=benefits%20of%20green%20buildings,reducing% 20emissions%20and%20other%20waste [https://perma.cc/cf9g-fg8j] (last visited mar. 1, 2023). 116. id. 117. karell, supra note 114. 118. charles lockwood, building the green way, harv. bus. rev. (june 2006), https://hbr. org/2006/06/building-the-green-way [https://perma.cc/qn7m-e43j]. 119. green building and design: the future of sustainable design, ohio univ. (july 20, 2022) https://onlinemasters.ohio.edu/blog/green-building-and-design/ [https://perma.cc/d766qjn3]. 120. rebecca thiele, how many hoosiers are getting their power shut off? a state agency wants more info, wfyi indianapolis (july 7, 2022) https://www.wfyi.org/news/articles/howmany-hoosiers-are-getting-their-power-shut-off-a-state-agency-wants-more-info [https://perma.cc/wj37-666h]. 121. id. 216 indiana health law review [vol. 21:199 create less long-term maintenance costs.122 the savings from green buildings return the initial investment in green materials and construction; if a property owner initially pays for more durable construction materials and energy efficient appliances, they will experience the savings from those improvements perpetually.123 marc karell, president of the energy and environmental consulting firm climate change & environmental services, describes the return on green building investment: if a building owner saves, say, $10,000 per year in electricity costs the first year after changes, the savings will not only be the same $10,000 the next year, but actually more, as savings are based on a utility rate which only rises in time (how often do utilities lower their electric or gas rates?). the second year, the cost savings may well be $10,300, and the third year, $10,700, etc., for as many years as the technologies last. for led lighting, that could mean seven to ten years or more; and all without having to do any additional efforts.124 pl 180 precludes hoosiers and indiana communities from investing in the perpetual savings that green buildings provide. consequently, indiana residents will see increasing utility and structural maintenance costs as fossil-fuel-powered energy costs rise125 and conventional building infrastructure deteriorates.126 further, hoosiers who own homes not built or retrofitted according to green building practices will miss out on higher property values, since green singlefamily residences can command up to an estimated $15,000 increase in home value.127 additionally, pl 180 detracts from environmentally conscious talent, business, and technology.128 hoosier environmental council executive director jesse kharbanda said, “this [law] will hamper the plans of any indiana cities that might have aspired, for economic development, talent attraction and retention, and/or quality of life reasons, to be at the national forefront of being an all-around environmentally sustainable city.”129 branding is powerful; companies push environmental branding because many consumers care about the environmental impact of their purchasing power.130 the city of scottsdale, arizona realized that green branding attracts customers to their green building program when cooperative builders display their green logo.131 pl 180 disincentivizes companies who want to make an environmental impact from coming to indiana 122. rabin, supra note 28. 123. karell, supra note 114. 124. id. 125. knakmuhs, supra note 108. 126. rabin, supra note 28. 127. hill & martinez-diaz, supra note 113. 128. saenz, supra note 4. 129. id. 130. see city of scottsdale, supra note 57. 131. id. 2024] how our buildings shape us 217 communities, an expense which is not borne by legislators, but directly borne by residents and communities. through pl 180, our legislature has limited the types of economic development opportunities indiana may attract, and instead has given that financial benefit to gas and construction companies. pl 180 reduces communities’ ability to reduce costs from energy and building maintenance, while constraining avenues to invite new opportunities to stimulate their local economies. d. pl 180 diminishes indiana communities’ resilience from the effects of climate change the u.s. department of health and human services defines community resilience as “the sustained ability of communities to withstand, adapt to, and recover from adversity.”132 the department connects community resilience to human health, noting that health is a “key foundation” of community resilience because much of the department’s purpose is in the “interest of human health and welfare.”133 communities are collectively healthier and more resilient when their residents are protected by durably built environments with reliable energy sources. however, pl 180 precludes indiana communities from reaching their full potential to create resiliency by precluding them from requiring that homes and buildings be constructed or retrofitted through robust and sustainable green building codes. green buildings improve human health not only through use of materials which reduce or avert the effects of pollution from conventional materials, but also by protecting hoosiers and communities through buildings constructed to withstand severe natural disasters.134 green buildings consider sea level rise, extreme temperatures, severe storms, and other climate risks that can deteriorate or destroy the structures that humans live and work in.135 for example, newly constructed leed certified buildings resilient from flooding are built with consideration of the 500-year floodplain, and existing leed certified buildings below the 500-year floodplain develop a detailed flood plan with on-site supplies and modifications for electrical switches outside the reach of high water levels.136 heat resistant leed certified structures provide external shade areas with access to water sources, implement drought-resistant plants that provide shade, and use 132. community resilience, u.s. dep. of health & human serv. (june 9, 2015), https://www.phe.gov/preparedness/planning/abc/pages/community-resilience.aspx#:~:text= community%20resilience%20is%20the%20sustained,big%20part%20of%20overall%20resilience. [perma.cc/2md5-bk4p]. 133. id. 134. design for enhanced resilience, u.s. green bldg. council, https://www.usgbc.org/ credits/enhancedresilience [https://perma.cc/6nlh-45tm] (last visited march 13, 2023). 135. why green building is synonymous with resilience, u.s. green bldg. council, https://www.usgbc.org/articles/why-green-building-synonymous-resilience (last visited march 13, 2023) [https://perma.cc/3drj-6lfc]. 136. design for enhanced resilience, supra note 134. 218 indiana health law review [vol. 21:199 high-reflectivity paving materials like concrete, a material more durable than asphalt or gravel. similarly, renewable energy sources are a characteristic of green buildings that can support resiliency by providing reliable power in the event of power outages caused by natural disasters.137 as indiana experiences more symptoms of climate change, energy derived from renewable sources like solar panels and wind turbines can maintain power to cooking appliances, medical equipment, or keep families warm during colder winters and cool during hotter summers. renewable energy sources save lives: the blue lake rancheria tribe in northern california reported that their solar grid saved four tribal members’ lives by powering essential medical devices during a multi-day power outage.138 while renewable energy sources can save lives, green buildings can also help can help people heal faster, improve mental health, lower the need for pain medication, and improve indoor air quality.139 as climate disasters become more severe — disasters able to destroy homes or leave residents stranded in their homes without power — indiana communities must be able to help residents prevent as much harm as possible and recover from harm quickly.140 green buildings are a necessary step in saving lives, bouncing back, and creating meaningful community resilience. further, lower income communities are more susceptible to health-related effects of climate change from power outages and extreme heat waves.141 in robert r.m. verchick’s book arguing that the federal government should assume a stronger regulatory role in managing natural infrastructure and public risk in our post-hurricane katrina world, he notes that “[c]atastrophe is bad for 137. michael panfil, resiliency +: renewable energy can boost grid resilience in vulnerable new jersey, env’t. defense fund (april 30, 2014), https://blogs.edf.org/energy exchange/2014/04/30/resiliency-renewable-energy-can-boost-grid-resilience-in-vulnerable-newjersey/#:~:text=renewable%20energy%20can%20increase%20energy,wake%20of%20a%20nat ural%20disaster [https://perma.cc/yh3v-k8k7]. 138. alexander dane & katie pastor, 3 ways us cities are investing in clean energy for resilience, world resources inst. (june 16, 2020), https://www.wri.org/insights/3-ways-uscities-are-investing-clean-energy-resilience [https://perma.cc/q4hr-3zbq]. 139. rahman, supra note 41. 140. see kaitlyn radde, storms across the u.s. cause deaths and power outages, npr (mar. 4, 2023), https://www.npr.org/2023/03/04/1161131706/storms-deaths-power-outages-extremeweather-wind-snow [https://perma.cc/se2l-qlda]; staggering snowfall in california leaves residents trapped for days, cbs news (mar. 2, 2023), https://www.cbsnews.com/news/californiasnow-winter-storm-residents-trapped/ [https://perma.cc/pl5p-a6uu]; irina ivanova, millions of americans are fleeing their homes because of extreme weather, cbs news (feb. 14, 2023), https://www.cbsnews.com/news/climate-change-displaced-millions-from-homes-extreme-weathernatural-disaster/ [https://perma.cc/4gfw-3ylp]. 141. kaiyu sun, et al., passive cooling designs to improve resilience of homes in underserved and vulnerable communities, science direct (dec. 2021), https://www. sciencedirect.com/science/article/abs/pii/s0378778821006678 [https://perma.cc/z7ge-mns9]. 2024] how our buildings shape us 219 everyone. but it is especially bad for the weak and disenfranchised.”142 verchick’s assertion is particularly true in relation to the effects of climate change.143 pl 180 precludes local governments from requiring green building practices in communities where environmentally conscious construction could be lifesaving to those who cannot afford higher cooling and heating rates. for example, a study found that passive cooling measures, which operate without power, can be effective if the method is tailored to the particular building.144 however, pl 180 prohibits local governments form requiring that buildings be built or retrofitted with any energy-saving design like passive cooling. pl 180 precludes indiana local governments from requiring that homes and built environments be constructed or retrofitted to protect hoosiers’ lives or help them recover from the physical effects caused by severe weather and temperatures. in this way, pl 180 works against the historical purpose of building codes to protect the public; instead, the law makes communities vulnerable and unsafe to our increasingly dangerous climate, which could result in injury and death to hoosiers. indiana’s legislature has decreased communities’ ability to adapt, withstand, and recover from the effects of climate change for the benefit of industries which are directly making our climate more threatening. e. pl 180 undercuts the historical purpose of home rule power local governments derive their power to control municipal and regulatory activities from the state in which they are located, usually through general statutes, constitutional provisions, or local charters.145 one way states grant power to local governments is through constitutional or statutory home rule. home rule is generally celebrated as a state’s most meaningful grant of independence to its local governments, though there is great variation of home rule powers among states.146 home rule grants local governments discretion over government form, structure, functions, fiscal, and regulatory matters, unless the state has specifically retained certain powers through statutory or constitutional preemption.147 proponents of home rule believe that effective local government depends on local autonomy from the state government, that local governments 142. robert r.m. verchick, facing catastrophe: environmental action for a postkatrina world 104, 336 (harvard university press, 1st ed., 2010); see also farber & carlarne, supra note 68. 143. farber & carlarne, supra note 68. 144. sun et al, supra note 141. 145. daniel l. mandelker et al., state and local government in a federal system, 95, 988 (2021). 146. kate leo shaffner, what is home rule? whyy (july 24, 2014) https://whyy.org/articles/ what-is-home-rule/ [https://perma.cc/6vj8-j9ma]; see also home rule in the midwest, ind. univ. pub. pol’y inst. (july 2010), https://ppidb.iu.edu/uploads/publicationfiles/pc_hmrules_ web.pdf [https://perma.cc/4auw-8vdm]. 147. mandelker et al., supra note 145 at 108; see also home rule in the midwest, supra note 145. 220 indiana health law review [vol. 21:199 can best address their community’s needs, and that the state legislature should focus on uniform statewide policies rather than specific local issues.148 home rule gives authority to local governments to “evolve solutions” to local problems without seeking state approval.149 the constitutional home rule movement developed in the late nineteenth century from a desire to provide local governments with autonomy in deciding matters of local importance and to preclude “governmental favoritism in the form of special privileges to favored private actors.”150 the “urban reformers” who championed the home rule movement sought to protect the public from special state legislation influenced by private actors which created higher levels of local taxing and spending.151 the reformers deemed the special favors conferred by law to private actors as a burden on local units of a “particularly odious species.”152 indiana adopted its home rule statute from the home rule act of 1980.153 under the home rule act, indiana local governments have broad authority to adopt any local law needed for “the effective operation of government as to local affairs.”154 however, there is a long list of restrictions to local control, and local laws may be invalidated if they are preempted by a state law.155 critics assert that the indiana general assembly has not honored our home rule statute because legislators have continuously preempted local government power.156 pl 180 is another example of state preemption which undercuts the historical purpose of home rule because the final adoption authority of building codes is commonly left to local governments.157 interestingly, while pl 180 includes a provision for control of vehicles, much of pl 180 controls building codes and the energy sources used in buildings, but the law was not placed in indiana’s administrative code where indiana’s minimum building codes are located.158 further, indiana sets statewide minimum building codes but leaves control of 148. susan barnhizer rivas, the indiana home rule act: a second chance for local selfgovernment, 16 ind. l. rev. 677, 704 (1983). 149. id. 150. david j. barron, reclaiming home rule, 116 harv. l. rev. 2255, 2293 (2003); see also mandelker et. al, supra note 145, at 107. 151. rivas, supra note 148. 152. id. 153. ind. code § 36-1-3-1 (2022); see also home rule in the midwest, supra note 143 (describing indiana’s home rule act). 154. ind. code § 36-2-3-2 (2022). 155. ind. code §§ 36-1-3-8,5 (2022). 156. some other issues preempted by the indiana general assembly are plastic bag bans, setting of local minimum wages, regulation of housing and agricultural operations, worker schedules, and “good neighbor” ordinances. see joshua claybourn, claybourn: in defense of hoosier home rule, indianapolis star (may 7, 2017), https://www.indystar.com/story/opinion/ 2017/05/07/claybourn-defense-hoosier-home-rule/101289696/ [https://perma.cc/me7d-p4hs]. 157. rossberg & leon, supra note 11. 158. indiana’s minimum building codes are located in title 675 of the indiana administrative code. 2024] how our buildings shape us 221 building code adoption and enforcement to individual cities and towns.159 in fact, many indiana counties and cities have adopted their own building codes in their local laws.160 pl 180’s placement in indiana’s home rule statute, instead of our administrative code, reveals that rep. pressel and the legislators who passed the law were seeking control through preemption, not public safety through building code requirements. pl 180 is an example of the “odious” nature of state control that the home rule reformers worked against: a law which takes power from local governments and gives it to private companies, at the expense of individual residents and communities.161 iv. legal solutions to pl 180 the indiana general assembly must repeal or place a sunset provision upon pl 180. a sunset provision would terminate the law at a certain point chosen by the legislature, potentially because pl 180 is not actually a pandemic protection, because fossil fuel powered energy source prices will become increasingly high, or because climate change will become more destructive to our built environment – all reasons that undermine pl 180’s purported purpose. however, as the effects of climate change command a more urgent response and negatively affect our physical, economic, and environmental health, hoosiers cannot wait for the indiana general assembly to repeal or place a termination point on the law. hoosier lawyers must instead challenge pl 180. an opportunity to challenge the law as unconstitutional may lie in the privileges and immunities clause of the indiana constitution: “the general assembly shall not grant to any citizen, or class of citizens, privileges or immunities, which, upon the same terms, shall not equally belong to all citizens.”162 in collins v. day, the indiana supreme court enumerated the history of article 1, section 23 of the indiana constitution as well as the test to determine whether the state legislature has violated the clause.163 framers of the indiana constitution included the privileges and immunities 159. indiana building code, permit, and licensing information, permit place (jan. 11, 2023), https://permitplace.com/state/indiana-permit-building-code-and-licensinginformation/#:~:text=indiana%20state%20wide%20building%20codes,without%20plan%20revi ew%20or%20inspection [https://perma.cc/fsp3-72gd]. 160. some examples of indiana municipal building codes are: the consolidated city of indianapolis’ municipal building code, see building standards and procedures, city of indianapolis, https://www.indy.gov/activity/building-standards-and-procedures [https://perma.cc/ z5pg-akk6] (last visited mar. 18, 2023); richmond, in’s municipal building code, see richmond city code, title xv, ch. 150 (2021) [https://perma.cc/76da-uuah]; allen county, in created a building department to enforce their local building code, which was enacted for the “protection of life, limb, health, environment, public safety and welfare, and for the conservation of energy,” see building department, allen cnty., ind., https://www.allencounty.us/building-department [https://perma.cc/xc69-234a] (last visited mar. 18, 2023). 161. barron, supra note 148. 162. ind. const. art. 1§, 23. 163. collins v. day, 644 n.e.2d 72 (ind. 1994). 222 indiana health law review [vol. 21:199 clause specifically to prohibit the legislature from giving favors or immunities involving the state’s participation in commercial enterprises.164 the clause was first discussed during the constitutional convention which met in late 1850 and early 1851, when the state had become “bankrupt” after issuing bonds that had greatly depreciated and “utterly ruined” the state’s credit after the public works programs they were intended to finance had been left uncompleted.165 the state then authorized private companies to finish the projects, issuing more bonds and levying taxes for counties, which caused “heavy and onerous debts” to many counties.166 one month before he introduced section 23, monroe county delegate daniel read asserted: money making is not the business of the state . . . . if she sells out a monopoly for a bonus, the robbery upon the citizens is ordinarily still worse, as being paid for and sanctified by a right purchased from government. if the state becomes a partner with a few of her citizens, to the exclusion of others, offering the same terms, it is still a most odious and anti-republican principle . . . .167 the indiana supreme court found that during the years following the ratification of the 1851 indiana constitution, “section 23 was often applied to invalidate enactments which, rather than granting special privileges, imposed special burdens.”168 through a consideration of caselaw applying section 23, the court found that no cases have declined to apply the section just because a statute created a special burden rather than a special privilege — this is because “implicit in an enactment that imposes an unequal burden is the grant of a special privilege or immunity to persons or classes exempted from the new burden.”169 collins enumerates a test based on two requirements for statutes that grant unequal privileges or immunities to differing classes. first, the disparate treatment accorded by the statute must be reasonably related to inherent characteristics which distinguish the unequally treated classes.170 the distinctions must involve something more than characteristics which serve to divide or identify the class; instead, there must be inherent differences in situations related to the subject matter of the statute which require, necessitate, or make expedient different or exclusive legislation with respect to the members of the class.171 second, the preferential treatment must be uniformly applicable and equally available to all persons similarly situated.172 this prong of the collins test requires that “any privileged classification must be open to all persons who share 164. id. at 77. 165. id. at 76. 166. id. (quoting lafayette, m., b. r.r. co. v. geiger, 34 ind, 185, 206 (ind. 1870)). 167. id. 168. id. at 77 (emphasis added). 169. id. 170. id. at 80. 171. id. at 78. 172. id. 2024] how our buildings shape us 223 the characteristics which distinguish and justify the classification.”173 the court must give substantial deference to the legislature and balance the competing interests involved.174 the burden of proof is upon the challenger “to negative every conceivable basis” which could support the classification.175 in collins, a farm worker who broke his leg while working was denied worker’s compensation because his employer had not agreed to provide worker’s compensation coverage under the indiana worker’s compensation act. the act, enacted in 1915, explicitly excluded “farm or agricultural employees” from its coverage, and allowed those employers to choose whether or not they wanted to provide worker’s compensation to their employees.176 the farm worker brought a section 23 claim, contending that the agricultural exemption extended to a “special class of employers an immunity denied to the general class of employers.”177 he also contended that the option for agricultural employers to be covered by or exempt from the indiana worker’s compensation act was a privilege denied to both a class of agricultural employees and to the general class of indiana employers.178 the court found that the inherent characteristics between the agricultural employees and employers and the general class of employers were reasonably related to the act’s exemption.179 the court also found that the exemption from worker’s compensation for agricultural employees was “uniformly applicable and equally available to all persons who are or may become agricultural employers.”180 pl 180 creates a classification between building materials and appliances based on their energy source; the law protects non-energy saving components but does not protect energy-saving components. in granting a protective privilege to conventional materials and natural gas-powered appliances by creating a space where they may always be employed, the law places a burden on green building materials and electric powered appliances by allowing space for them to be banned. consequently, the law creates security for companies which use conventional materials or implement natural gas-powered appliances, while creating a vulnerability for companies which implement green building practices 173. id. at 79. 174. id. at 79-80. 175. id. at 80 (quoting johnson v. st. vincent hosp., 273 ind. 374, 392 (ind. 1980)). 176. id. at 73; see also indiana worker’s compensation insurance, hartford ins. grp., https://www.thehartford.com/workers-compensation/indiana#:~:text=indiana%20workers'%20 compensation%20act,act%20of%20indiana%20in%201915.&text=the%20act%20created% 20a%20workers,recover%20and%20return%20to%20work [https://perma.cc/v5k5-pghd] (last visited mar. 22, 2023) (describing the indiana worker’s compensation act). 177. collins, 664 n.e.2d at 74. 178. id. (collins also asserted that the indiana supreme court should apply the fourteenth amendment of the u.s. constitution to his case, which the court declined to do, finding that section 23 should be given independent interpretation.). 179. id. at 81. 180. id. at 82. 224 indiana health law review [vol. 21:199 and electric appliances. further, pl 180 creates a protected industry which incentivizes companies to manufacture and use the protected materials and appliances, creating an imbalance in the construction and appliance market. producers are more likely to manufacture goods that are inherently protected than those that are vulnerable or less likely to be used. several indiana construction companies specialize in green building: lancia homes, gh homes, fall creek homes, cedar street builders, and commodore homes.181 these companies constitute a group of possible petitioners similarly situated to the protected construction companies, that endure a burden from pl 180 because of the security given to conventional construction companies that is denied to them. these companies are at risk to be banned from building in local communities, while other companies using conventional materials are not. a petitioner must first demonstrate that the vulnerability that pl 180 creates for green construction companies and electric appliances is not reasonably related to the inherent characteristics of the class distinctions. there are not inherent differences in the construction and energy sources classified by pl 180 that require exclusive legislation. conventional and green construction companies do the same things – build or retrofit structures. while green construction employees require different levels of training than conventional construction employees, extra training is counterbalanced with the protection and durability it ultimately provides to hoosiers and indiana communities from the effects of climate change. if construction companies take extra time or expense to learn to use green technologies and materials, their construction will last longer and be more protective. further, unlike the difficulty that agricultural employers face in passing additional costs to consumers, both conventional and green construction companies directly pass their costs to property buyers. similarly, natural gas and electricity producers do the same thing – power appliances. pl 180 is an unnecessary preventative measure for a feared natural gas ban which no indiana cities have attempted.182 in the broader national conversation about natural gas bans, states are not likely to apply the ban to homes already using natural gas appliances; they would only apply the ban to appliances in newly built homes.183 of course, because no indiana cities have attempted to ban natural gas-powered appliances, we do not know what a potential indiana ban would entail. preventative legislation like pl 180 does not demonstrate any need for exclusive legislation or classification between energy sources that are both currently in use without any limitation. second, a petitioner must show that the preferential treatment pl 180 creates 181. the top 7 sustainable green home builders in indiana, attainable home (mar. 26, 2022), https://www.attainablehome.com/the-top-7-green-home-builders-in-indiana/ [https://perma.cc/yhj9-q6ap]. 182. id. 183. ty roush, u.s. regulators and state lawmakers consider banning natural gas stoves–here’s why, forbes (jan. 11, 2023), https://www.forbes.com/sites/tylerroush/2023/01/11/ us-regulators-and-state-lawmakers-consider-banning-gas-stoves-heres-why/?sh=386078204e49 [https://perma.cc/fz7f-bvbt]. 2024] how our buildings shape us 225 is not uniformly applicable to all persons similarly situated. the protective privilege that pl 180 provides to conventional construction companies and natural gas-powered appliances is not open to companies which use green materials or implement electric appliances. finally, a petitioner must negate every “conceivable basis” for the law because the court will show substantial deference to the legislature.184 the known reasons behind the passage of the law are maintaining a “cheaper” form of energy for hoosiers during the covid-19 pandemic and preventative protections for natural gas.185 neither of these points create a reasonable basis for a protective classification for one group of construction companies or type of appliance over the other. rep. pressel’s assertion that natural gas-powered appliances are cheaper for hoosiers is becoming increasingly untrue as natural gas becomes more scare and supply becomes limited through world events like the russia/ukraine war.186 additionally, the state of indiana ended its public health emergency status resulting from the covid-19 pandemic on march 3, 2022.187 if pl 180 is a law to protect hoosiers during the covid-19 pandemic, then it should have been a temporary measure which ended with the conclusion of the public emergency status, like rental assistance or increased snap benefits.188 the preventative measure taken through pl 180 because of the fear of the legislature with close ties to natural gas and conventional construction companies do not constitute a reasonable basis to offer them protection while creating a vulnerability for others. finally, roger horner offers a note for hoosier lawyers filing environmental claims.189 rule 2.1 of the model rules of professional conduct advises: “in rendering advice, a lawyer may refer not only to law but to other considerations such as moral, economic, social, and political factors that may be relevant to the client’s situation.”190 the legislative history and the substance of pl 180 provides moral, political, economic, environmental, and social arguments for hoosiers and indiana communities. pl 180 is an ethically questionable law because our legislature has chosen to support gas and construction companies at the expense of indiana residents, and further, rep. pressel used his platform as an elected legislator to protect his business instead of his constituents. the law imposes a burden to communities’ financial health by forcing hoosiers to pay higher utility bills and higher insurance rates and decreases property values. hoosiers will 184. collins, supra note 163 at 79. 185. sarah bowman & london gibson, banning natural gas would cut emissions. but lawmakers don’t want that happening in indiana., indianapolis star (mar. 3, 2021), https://www.indystar.com/story/news/environment/2021/03/03/indiana-general-assembly-tries-stopcities-banning-natural-gas/4540329001/ [https://perma.cc/y724-jbwc]. 186. knakmuhs, supra note 108. 187. see supra text accompanying note 76. 188. bowman and gibson, supra note 185. 189. roger horner, saving the world: how municipal lawyers can help in the fight against climate change, mun. law. 15, 35 (jan 2023). 190. id. at 15; see also model rules of professional conduct, rule 2.1, cmt. 2 (2023). 226 indiana health law review [vol. 21:199 continue to suffer from the negative effects to their health and their environment from ghg emissions from conventional building infrastructure. finally, pl 180 decreases our ability to survive and bounce back from the effects of climate change. indiana residents will lose friends and family members — unnecessarily — without the ability for local governments to reach their full potential to protect their residents, especially in communities which are already the most vulnerable. these are all arguments that hoosier lawyers should consider when challenging pl 180. v. conclusion building codes were enacted to provide safety for the public as they engaged with their built environments.191 green building codes expand upon the historical purpose of conventional building codes by reflecting society’s increasing need for protection and resilience in the face of the worsening effects of climate change.192 extreme temperatures, flooding, severe storms, and disease-spreading mosquito populations are all necessary reasons to adopt green building codes, just as the 1871 great chicago fire and the 1906 san francisco earthquake caused state legislators to act for the protection of their residents. the indiana general assembly must allow local indiana governments to require green building codes in order to reduce the effects of a warming climate in their own localities and protect hoosiers’ lives. indiana’s built environments must reflect trust that our legislature is enacting laws for our benefit and protection, not for private companies. winston churchill was not likely thinking about climate change when he asserted that our buildings symbolize the strength of our democratic system, but his assertion that our buildings shape our ability to trust that our leaders will protect us still applies today. 191. cocke, supra note 7. 192. green building standards, supra note 22. a breath of polluted air: how indiana’s air pollution policies are impacting its citizens kyle andrew tucker* i. introduction nestled between two rivers, at the tip of indiana’s most southern point, lies evansville, indiana, a town of approximately 119,000 residents.1 of those residents, resided a 12-year-old boy named kavon cooper who suffered from severe asthma.2 so severe that it restricted the amount of time kavon could spend outside or whether he could stay at a friend’s house overnight; because of this, kavon spent most of his time indoors, windows shut, playing video games.3 this was his norm, at least until he collapsed and died in his home on april 18, 2015.4 the coroner ruled kavon’s death “an acute asthma attack” and the only explanation that kavon’s mother, kris dasch, received was that the “pollen had spiked” that day.5 however, something else had spiked the previous day and continued to spike on the day kavon died, it was “fine particulate matter.”6 fine particulate matter are tiny toxic specs that are released into the air by emissions from coal-fired power plants, vehicles, and other factories.7 according to the air monitor, less than half a mile away from kavon’s home, fine particulate matter had increased twenty micrograms per cubic meter the day before kavon died, and then increased by an additional nine micrograms per cubic meter the next day.8 dr. carrie a. redlich, director of the yale occupational and environmental medicine program believes that air pollution was at the very least, a contributing factor in kavon’s death.9 however, kavon cooper’s death is not an isolated one. approximately sixtyfive miles north of evansville, in washington, indiana, 3-year-old leighton fry suffers from chronic asthma which requires two daily breathing treatments and * j.d. candidate, 2020, indiana university robert h. mckinney school of law—indianapolis; b.a., 2015, indiana university—bloomington. 1. quick facts evansville city, indiana, u. s. census bureau, https://www.census.gov/ quickfacts/fact/table/evansvillecityindiana/pst045218 [https://perma.cc/q2xu-xaxk]. 2. jamie smith hopkins, america’s super polluters. many states have at least one. in southwest indiana, there are four, ctr. for health journalism (sept. 30, 2016), https://www.centerforhealthjournalism.org/fellowships/projects/america’s-super-polluters [https://perma.cc/g83b-etj3]. 3. id. 4. kavon cooper, courier & press (apr. 22, 2015), https://obits.courierpress.com/ obituaries/courierpress/obituary.aspx?n=kavon-cooper&pid=174688817 [https://perma.cc/48dt9cdc]. 5. hopkins, supra note 2. 6. see id. 7. id. 8. id. 9. id. 340 indiana health law review [vol. 17:339 up to five other medications.10 the fry house is located eight miles downwind from indianapolis power & light company’s petersburg plant in gibson county.11 leighton’s pediatrician, norma kreilein, is certain that air pollution is the causation of leighton’s asthma, and also for other respiratory illnesses found in children in the area, stating “[t]he [link] is a mathematical certainty. pollutants are inflammatory. it’s the same link we see with cigarette smoke.”12 a contributing factor to air pollution in southwest indiana are the seven coalfired power plants within the region.13 of the seven, four are what the center for public integrity have dubbed “super polluters.”14 to determine a super polluter, the center engaged in a nine-month long study that merged two federal datasets on united states air pollutants in 2014.15 through the study, they found that out of 20,000 registered facilities, a third of all toxic air releases came from 100 facilities; and a third of all greenhouse gas emissions came from 100 facilities—with twenty-two facilities being on both lists.16 these twenty-two facilities came to be known as “super polluters.”17 the four southwest indiana super polluters include: the indiana-michigan power’s rockport plant in spencer county, the indianapolis power and light plant in pike county, the duke energy’s gibson power plant in gibson county, and the alcoa and vectren generating unit in warrick county.18 together they emit millions of tons of toxic air pollution per year; so much in fact, that activist have started referring to southwest indiana as “the sacrifice zone.”19 a. a brief history of coal coal has had a deep developmental and social impact on the world and especially the united states. prior to coal, wood was the world’s primary energy source.20 but due to increased populations, development, and deforestation, wood was no longer viable, and the world transitioned to coal throughout the 19th 10. bob segall, 13 investigates: indiana’s toxic air, wthr (apr. 14, 2016, 9:34 pm), https://www.wthr.com/article/13-investigates-indianas-toxic-air [https://perma.cc/9e3a-w2mn]. 11. id. 12. id. 13. see hopkins, supra note 2. 14. id. 15. id. 16. id. 17. id. 18. mark wilson, super polluters tour gives people close up look at where hoosiers get their power, courier & press (aug. 17, 2018, 1:42 pm), https://www.courierpress.com/story/ news/local/2018/08/17/sou thwest-indiana-power-plants-super-polluters-tour-sierraclub/1019414002/ [https://perma.cc/p2xy-j675]. 19. id. 20. coal in the u.s. and indiana, ind. geological & water surv., https://igws.indiana. edu/coal/ [https://perma.cc/8nds-8dxn]. 2020] how indiana’s air pollution policies are impacting its citizens 341 century.21 this transition was especially correlated to the increased number of steam-powered locomotives like ships and trains: to say, as coal consumption increased, so did the expansion of railroads and ships in the united states.22 it can most easily be seen through the production and demand for coal. for example, in 1850, the us produced approximately 9.3 million tons of coal, this number jumped to 750 million by 1918 and by the 1940s, it was responsible for up to 75% of us energy.23 therefore, coal has greatly influenced and is attributable to the gains in economic and social developments for the last 150 years. this is especially true in the united states simply because of its abundance. there is estimated to be 257 billion tons of coal in the us, which accounts for “more than one-fourth of the world’s total known coal reserves.”24 coal seemed like a solution to all energy issues. however, by the 1970s, air pollution in general was a noticeable problem. this led to president richard nixon signing the clean air act (“caa”) in 1970 with the goal of “foster[ing] the growth of a strong american economy and industry while improving human health and the environment.”25 by 1990, the caa is estimated to have “prevented more than 200,000 premature deaths, and almost 700,000 cases of chronic bronchitis.”26 then, after caa revisions in 1990, the epa was responsible for decreasing six criteria air pollutants (carbon monoxide, particulate matter, nitrogen oxides, sulfur dioxide, lead, and ozone) by forty-one percent, “while the gross domestic product increased by more than 64 percent.”27 the reduction of air pollution while simultaneously increasing gdp is proof that environmental and economic policies can coexist for the benefit of both sectors. b. coal’s impact on indiana why are there so many coal-fired power plants in southwest indiana? as just explained above, it’s big coal country. specifically, southwest indiana is the only part of the state that has access to the illinois basin, one of the largest coal basins 21. id. 22. tristan, the history of wood and coal in industrial transport, burycoal (feb. 26, 2010), http://burycoal.com/blog/2010/02/26/the-history-of-wood-and-coal-in-industrial-transport/ [https://perma.cc/czw8-jzcf]. 23. coal in the u.s. and indiana, supra note 20. 24. our energy sources, fossil fuels, coal, nat’l acads. sci., eng’g, med., http://needtoknow.nas.edu/energy/energy-sources/fossil-fuels/coal/ [https://perma.cc/wp6e-7ch6]. 25. 40th anniversary of the clean air act, u.s. envtl. prot. agency (sept. 14, 2010), https://www.epa.gov/clean-air-act-overview/40th-anniversary-clean-air-act [https://perma.cc/cs66wsuu]. 26. id. 27. id. see managing air quality, u.s. envtl. prot. agency, https://www.epa.gov/airquality-management-process/managing-air-quality-air-pollutant-types [https://perma.cc/wfu47npm]. 342 indiana health law review [vol. 17:339 in the us.28 in all, indiana has roughly fifty-seven billion tons of unmined coal but only seventeen billion tons is accessible with current technology.29 still, of the 17 billion tons of accessible coal, it is estimated to last indiana up to 500 years.30 according to indiana’s department of natural resources (“dnr”), indiana produces up to thirty-five million tons of coal each year, consistently making it a top ten coal producing state in the country.31 indiana’s dnr contributed coal production to “ten southwestern indiana counties” which results an additional $750+ million to indiana’s economy.32 indiana consumes approximately 75% of the 30 million tons of coal it produces each year (shipping the remaining to other states) and imports coal from west virginia, kentucky, illinois, and wyoming to meet remaining demands.33 due to coals abundance and cheap source of energy, indiana relies on it heavily. in 2018, 70% of indiana's electricity was generated by coal.34 out of indiana’s 44,792 thousand short tons of coal consumption, 39,144 thousand short tons of it are used for electricity, making it the second largest-coal consumer in the country only behind texas.35 36 28. indiana state profile and energy estimates, u.s. energy info. admin., https://www.eia.gov/state/analysis.php?sid=in [https://perma.cc/s3xz-f4e9]. 29. coal in the u.s. and indiana, supra note 20. 30. id. 31. indiana coal by the numbers, ind. dep’t nat. resources, https://www.in.gov/ dnr/reclamation/3464.htm [https://perma.cc/y9mc-nqdt]. 32. id. 33. indiana state profile and energy estimates, supra note 28. 34. id. 35. table f23: coal consumption estimates and imports and exports of coal coke, 2018, u.s. energy info. admin., https://www.eia.gov/state/seds/sep_fuel/html/pdf/fuel_use_cl.pdf [https://perma.cc/b3e4-jdq8]; id. 36. coal in the u.s. and indiana, supra note 20. 2020] how indiana’s air pollution policies are impacting its citizens 343 the amount of coal production and consumption therefore requires employment. the coal industry supplies up to 6,500 well-paying jobs in southwest indiana.37 further, because the cheap energy source provides an incentive for businesses, coal also relates to and is a cause for increased manufacturing jobs in indiana.38 in 2013, manufacturing employed over 16% (over 500,000 employees) of indiana’s workforce, the largest proportion for any state in the country.39 ii. pollutants produced by coal-fired power plants and their correlated health risks air pollution caused by coal occurs when the chemical bonds holding carbon together are broken to release energy.40 under the authority of the caa, air pollutants have been characterized and grouped into two separate emission standards by the united states environmental protection agency (“epa”).41 the first group, known as “criteria air pollutants” consists of six specific pollutants, and includes particulate matter (“pm”), carbon monoxide (“co”), lead (“pb”), nitrogen dioxide (“no2”), ozone, and sulfur dioxide (“so2”) which standards are controlled under the national ambient air quality standard (“naaqs”).42 the second group includes a multitude of other “cancer causing” pollutants classified as hazardous air pollutants (“haps”) and are controlled under the national emission standards for hazardous air pollutants (“neshaps”).43 a. criteria air pollutants particulate matter (“pm”) is a combination of solid particles and liquids found in the air and may contain a combination of up to “hundreds of difference chemicals.”44 pm is categorized into two separate groups based on its size: pm10 37. see economy at a glance, bureau of labor stats., https://www.bls.gov/eag/eag. in.htm [https://perma.cc/c8b4-39k5]. 38. see mark crawford, the states leading the u.s. manufacturing resurgence, area development (winter 2013), http://www.areadevelopment.com/regionalreports/q1-2013/statesleading-us-manufacturing-resurgence-2665542.shtml?page=2 [https://perma.cc/7t24-vdy8]. 39. id. 40. coal and air pollution, union concerned scientists (july 28, 2008, updated dec. 19, 2017), https://www.ucsusa.org/resources/coal-and-air-pollution[https://perma.cc/ebr2-k98w]. 41. ind. dep’t envtl. management, e101 – module one: air permitting 3 (2017), https://www.in.gov/idem/ctap/files/e101_air_manual.pdf [https://perma.cc/f4g3-gnuh]. 42. criteria air pollutants, u.s. envtl. prot. agency, https://www.epa.gov/criteria-airpollutants [https://perma.cc/64t7-y4gq]. 43. hazardous air pollutants, u.s. envtl. prot. agency, https://www.epa.gov/haps [https://perma.cc/w436-mwgc]. 44. particulate matter (pm) basics, u.s. envtl. prot. agency, https://www.epa.gov/pmpollution/particulate-matter-pm-basics [https://perma.cc/bm7m-jhml]. 344 indiana health law review [vol. 17:339 and pm2.5. 45 pm10 is generally ten micrometers across or smaller and can be inhaled; meanwhile pm2.5 is generally two and a half micrometers across and smaller (in comparison, a single strand of hair is about 70 micrometers across).46 although both pm10 and pm2.5 can be inhaled and cause health problems, pm2.5 is considered more dangerous because its size allows it to lodge deeper into the lungs where it can remain stagnant for many years or enter the bloodstream.47 therefore, long or short term exposure to both types of pm have been linked to “illnesses and deaths from heart or lung disease” especially for sensitive groups like the elderly, children and those with preconditions.48 specifically, people with heart or lung diseases may experience chest pain, palpitations, shortness of breath, asthma attacks, cardiac arrhythmias, or heart attacks, and are therefore “more likely to visit emergency rooms, be admitted to hospitals, or … even die.”49 further, chronic illnesses may develop, like: congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe asthma, and chronic bronchitis—leading to more medications and more doctor visits.50 carbon monoxide (“co”) is a colorless, odorless gas released when “something is burned” and can be harmful in large amounts.51 the primary producers of co are vehicles or machinery that burn fossil fuels.52 co causes health problems by entering the bloodstream and binding to hemoglobin (the component in blood that carries oxygen to cells)53 and reduces the amount of oxygen that can be transported to critical organs (i.e. the heart and brain).54 if inhaled in a confined space, co can “cause dizziness, confusion, unconsciousness and death.”55 due to the concentration levels that co needs to be harmful, it is unlikely for the health problems to persist while outside.56 however, the effects of co poisoning impact adults and children differently. the journal of toxicology conducted a two-year study where they found, in general, that adults with co poisoning resulted in symptoms “like headache, nausea, and coma were less frequent, whereas loss of consciousness, convulsions, and lethargy were more 45. id. 46. id. 47. health and environmental effects of particulate matter (pm), u.s. envtl. prot. agency, https://www.epa.gov/pm-pollution/health-and-environmental-effects-particulate-matterpm [https://perma.cc/tmb5-7nxs]. 48. craig n. johnston et al., legal protection of the environment 354-55 (4th ed. 2018). 49. id. 50. id. 51. basic information about carbon monoxide (co) outdoor air pollution, u.s. envtl. prot. agency, https://www.epa.gov/co-pollution/basic-information-about-carbon-monoxide-cooutdoor-air-pollution#what%20is%20co [https://perma.cc/p9uh-8unv]. 52. id. 53. johnston et al., supra note 48, at 355. 54. basic information about carbon monoxide (co) outdoor air pollution, supra note 51. 55. id. 56. id. 2020] how indiana’s air pollution policies are impacting its citizens 345 frequent in children than in adults.”57 further, the journal of toxicology found that the impacts of co poisoning effected a fetus more prevalently than the mother and that “the severity of fetal intoxication cannot be assessed solely by the maternal state.”58 symptoms for a fetus include neurological dysfunction, decreased birth weight, and a four times more likelihood of fetal death.59 lead (pb) is a natural metal that is emitted from coal-fired power plants.60 once in the body, lead “distributes throughout the body in the blood and is accumulated in the bones.”61 this accumulation can wreak havoc on the nervous system, immune system, cardiovascular system, kidneys, and reproductive and developmental systems.62 further, like co, it can affect the “oxygen carrying capacity of the blood.”63 pb most commonly effects children neurologically, including behavioral problems, learning deficits, and lowered iq (even in low amounts), and cardiovascular effects in adults.64 nitrogen dioxide (no2) is family to a group of highly reactive gases.65 it gets in the air primarily from burning fuels; therefore, automobiles and power plants are high producers.66 no2 primarily affects the respiratory system when inhaled.67 short periods of exposure can aggravate already existing respiratory diseases and long exposures may contribute to the development of asthma and respiratory infection.68 no2 reacts with other particles in the air to form particulate matter and ozone.69 further, it has been shown that children are again especially susceptible to excess levels of no2, including “daily personal exposure to no2 levels readily available in the domestic setting and chest tightness on the same day, breathlessness on exertion with a one-day lag, daytime and nighttime asthma attacks on the same day and with a one-day lag time.”70 ozone is a gas that is composed of three atoms of oxygen and occurs in both the atmosphere and at ground level and can have positive or negative health affects depending on where it is found.71 stratospheric ozone occurs naturally and 57. johnston et al., supra note 48, at 362. 58. id. 59. id. 60. see union concerned scientists, supra note 40. 61. id. 62. id. 63. id. 64. id. 65. basic information about no2, u.s. envtl. prot. agency, https://www.epa.gov/no2pollution/basic-information-about-no2#what is no2/ [https://perma.cc/g9ag-y87w]. 66. id. 67. id. 68. id. 69. id. 70. johnston et al., supra note 48, at 360. 71. ground-level ozone basics, u.s. envtl. prot. agency, https://www.epa.gov/groundlevel-ozone-pollution/ground-level-ozone-basics#wwh [https://perma.cc/w4as-gpcg]. 346 indiana health law review [vol. 17:339 is a protective layer against ultraviolet rays from the sun.72 however, ozone at the ground level has adverse effects against human health and is the primary proponent in smog.73 ground level ozone is created by “chemical reactions between oxides of nitrogen (nox) and volatile organic compounds (voc).”74 it occurs when pollutants from vehicles and power plants chemically react in sunlight.75 therefore, ozone reaches the most unhealthy levels on hot, sunny days,76 and it puts people who are active outdoors at the greatest risk because it penetrates deeper into the lungs during physical activity.77 ozone can reduce lung function, making it more difficult to breathe deeply; when ozone levels are high, it causes an increased amount of asthma attacks that require medication or doctor visits; ozone can cause an “increase[d] susceptibility to respiratory infections;” and “[o]zone can inflame and damage the lining of the lungs” which, if repeatedly occurs, can result in permanent scarring of the lungs and therefore lower lung functionality and an overall lower quality of life.78 sulfur dioxide (so2) is a toxic gas that is produced primarily from the “burning of fossil fuels by power plants . . . .”79 nasal passages naturally remove so2, so moderate activity, or activity that triggers mouth breathing, is needed to trigger health effects.80 exposure in small amounts affects the respiratory system, especially for children and people who suffer from asthma,81 and exposure specifically causes the “narrowing of the airways” which leads to “wheezing, chest tightness, and shortness of breath.”82 in larger amounts, the same symptoms can occur in healthy individuals.83 larger amounts of so2 emissions can also mix with other sulfur oxides in the air and contribute to creating pm.84 finally, longterm exposure of so2 “can cause respiratory illness, alter the lung’s defense mechanisms, and aggravate existing cardiovascular disease.”85 b. hazardous air pollutants hazardous air pollutants (haps) are pollutants that are known or expected to cause cancer or other serious health effects, including issues with the immune, 72. id. 73. id. 74. id. 75. id. 76. see johnston et al., supra note 48, at 358. 77. id. at 353. 78. id. at 354. 79. sulfur dioxide basics, u.s. envtl. prot. agency, https://www.epa.gov/so2pollution/sulfur-dioxide-basics#what is so2 [https://perma.cc/l5x4-mgdc]. 80. johnston et al., supra note 48, at 355. 81. sulfur dioxide basics, supra note 79. 82. johnston et al., supra note 48, at 355. 83. id. 84. sulfur dioxide basics, supra note 79. 85. johnston et al., supra note 48, at 355. 2020] how indiana’s air pollution policies are impacting its citizens 347 neurological, reproductive, developmental, and respiratory systems.86 haps most produced by power plants include metals like cadmium, mercury, and chromium.87 iii. federal and state emission standards a. federal emission compliance and monitoring standards for stationary facilities the authority for determining federal emission standards for coal-fired power plants falls under the epa. this authority is delegated to the epa from the clean air act of 1990 (caa).88 the caa creates two broad areas of regulatory authority: (1) for “criteria air pollutants” like fine particulate matter, carbon monoxide, lead, sulfur dioxide and nitrogen dioxide through the national ambient air quality standard (naaqs), and (2) for “hazardous air pollutants” (hap) through the national emission standard for hazardous air pollutants (neshaps). 1. national ambient air quality standard a. process of reviewing the national ambient air quality standards the national ambient air quality standards (naaqs) are contained under sections 108 and 109 of the caa with its primary purpose being for the epa to review and revise the science used to set standards for “criteria air pollutants.”89 a review of the naaqs is a comprehensive five step process which includes: planning, an integrated science assessment (“isa”), risk/exposure assessment (“rea”), policy assessment (“pa”), and rulemaking.90 the planning phase begins with a “science policy workshop,” that entails gathering input from the scientific community and the public “regarding policy-relevant issues and questions that will frame the review.”91 based from the input received, epa prepares an “integrated review plan” (“irp”) which outlines the schedule for the review, the process used to conduct the review, and the “policy-relevant science 86. health and environmental effects of hazardous air pollutants, u.s. envtl. prot. agency, https://www.epa.gov/haps/health-and-environmental-effects-hazardous-air-pollutants [https://perma.cc/nag3-j7lr]. 87. see id. coal and air pollution, supra note 40. 88. controlling hazardous air pollutants, u.s. envtl. prot. agency, https://www.epa.gov/ haps/controlling-hazardous-air-pollutants [https://perma.cc/q9eu-kd39]. 89. see criteria air pollutants, supra note 42. 90. process of reviewing the national ambient air quality standards, u.s. envtl. prot. agency, https://www.epa.gov/criteria-air-pollutants/process-reviewing-national-ambient-airquality-standards [https://perma.cc/4tsj-jbhx]. 91. id. 348 indiana health law review [vol. 17:339 issues” that will be covered.92 second, the isa phase is a more comprehensive assessment of the “most policy-relevant science.”93 third, the rea phase draws from the conclusions presented in the isa and used to “develop quantitative characterizations of exposures and associated risks to human health” that are associated with current air quality conditions and with air quality that is estimated to meet the current or possible alternative standards, including any uncertainties about the estimates.94 fourth, is the policy assessment phase, which provides an analysis of the “scientific basis for alternative policy options” under consideration by senior epa management.95 this phase helps connect how the epa decides whether to revise or retain current naaqs standards based on the scientific evidence collected in the earlier phases and the recommendation from the clean air scientific advisory committee (“casac”).96 the pa and casac focuses on evaluating the basic elements of the naaqs, which includes: indicator, averaging time, form, and level.97 finally, the rulemaking stage considers the information from all other stages and publishes a “notice of proposed rulemaking” that outlines the epa’s review of the naaqs.98 afterwards, a public comment period occurs, and a public hearing is usually held.99 the final rule is published once public comments are taken into consideration.100 b. the national ambient air quality standard designation process the naaqs designation process is implemented after a standard is created or revised to determine if areas of the country abide by them.101 the process begins by states submitting recommendations to the epa on whether an area within their jurisdiction meets the new standards.102 a state’s recommendation is based on monitors that collect air quality data and are located throughout the state.103 the epa then compares this data against the new standard to determine if an area is in “attainment or nonattainment.”104 an attainment area is a region that “meets or is cleaner than the [new] national standard” and no further step is necessary.105 a nonattainment area is a region that does not qualify under the new 92. id. 93. id. 94. id. 95. id. 96. id. 97. id. 98. id. 99. id. 100. id. 101. naaqs designation process, u.s. envtl. protection agency, https://www.epa.gov/ criteria-air-pollutants/naaqs-designations-process [https://perma.cc/r7ax-6yel]. 102. id. 103. id. 104. id. 105. id. 2020] how indiana’s air pollution policies are impacting its citizens 349 standard.106 under either designation state and local governments must develop implementation plans outlining how areas will attain and maintain the standards by reducing air pollution emissions.”107 c. the national ambient air quality standard state implementation plans once the designation process is finished, states must develop general plans for all areas concerning how an area will seek or maintain attainment and specific plans on how an area designated nonattainment will reach attainment. these are known as state implementation plans (sips).108 sips are developed by state and local “air quality management agencies” and must be approved by the epa.109 there are two purposes for sips: (1) they “[d]emonstrate that the state has the basic air quality management program components in place to implement a new or revised naaqs” and (2) they “[i]dentify the emissions control requirements the state will rely upon to attain and/or maintain the primary and secondary naaqs.”110 the sip development process begins with the designation of an area as achieving attainment or nonattainment.111 within three years after new naaqs are set, all states must submit a sip proving that they have the appropriate components to implement the new standards.112 sips for nonattainment areas are due within eighteen to thirty-six months, with varying dates being based on the type of pollution and area classification.113 for example, due dates for sulfur dioxide (so2), nitrogen dioxide (no2), coarse particle pollution (pm10), and lead (pb) are due no later than eighteen months after designation, and pollutants like ozone (o3), fine particle pollution (pm2.5), and carbon monoxide (co) are generally given thirty-six months from designation.114 these nonattainment sips must outline “the strategies and emissions control measures that show how the area will improve air quality and meet the naaqs.”115 further, “sips must be developed with public input, be formally adopted by the state, and submitted by the governor’s designee to epa.”116 the epa must then either approve or disapprove all or part of the plan after further consideration from the public and before its final action is enforced.117 if all or 106. id. 107. id. 108. naaqs implementation process, u.s. envtl. prot. agency, https://www.epa.gov/ criteria-air-pollutants/naaqs-implementation-process [https://perma.cc/697k-pu5l]. 109. id. 110. id. 111. id. 112. id. 113. id. 114. id. 115. id. 116. id. 117. id. 350 indiana health law review [vol. 17:339 part of a sip is approved, then it is enforceable in federal court, if a state does not pass the epa’s consideration, then the “epa is required to develop a federal implementation plan (fip).”118 d. national ambient air quality standard for each criteria air pollutant the clean air act identifies two separate national ambient air quality standards for criteria air pollutants: (1) the primary standard and (2) the secondary standard.119 the primary standard is designated for “public health protection including protecting the health of ‘sensitive’ populations such as asthmatics, children, and the elderly.”120 the secondary standard provides for “public welfare protection, including protection against decreased visibility and damage to animals, crops, vegetation, and buildings.”121 three separate units of measurements for criteria air pollutants are used and include “parts per million (ppm) by volume, parts per billion (ppb) by volume and micrograms per cubic meter of air (µg/m3).122 the following table is the epa’s current primary and secondary standard for each criteria air pollutant.123 pollutant primary/secondary average time level form carbon monoxide (co) primary 8 hours 9 ppm not to be exceeded more than once per year 1 hour 35 ppm lead (pb) primary and secondary rolling 3month average 0.15 µg/m3 not to be exceeded nitrogen dioxide (no2) primary 1 hour 100 ppb 98th percentile of 1-hour daily maximum concentrations averaged over 3 years primary and secondary 1 year 53 ppb annual mean 118. id. 119. naaqs table, u.s. envtl. prot. agency, https://www.epa.gov/criteria-airpollutants/naaqs-table [https://perma.cc/mm2s-rg25]. 120. id. 121. id. 122. id. 123. id. 2020] how indiana’s air pollution policies are impacting its citizens 351 ozone (o2) primary and secondary 8 hours 0.070 ppm annual fourthhighest daily maximum 8hour concentration, averaged over 3 years pm2.5 primary 1 year 12.0 µg/m3 annual mean, averaged over 3 years secondary 1 year 15.0 µg/m3 annual mean, averaged over 3 years primary and secondary 24 hours 35 µg/m3 98th percentile, averaged over 3 years pm10 primary and secondary 24 hours 150 µg/m3 not to be exceeded more than once per year on average over 3 years sulfur dioxide (so2) primary 1 hour 75 ppb 99th percentile of 1-hour daily maximum concentrations, averaged over 3 years secondary 3 hours 0.5 ppm not to be exceeded more than once per year 2. national emission standard for hazardous air pollutants haps are pollutants that are known or expected to cause cancer or other serious health effects, like reproductive birth defects.124 haps originate from 124. national emission standards for hazardous air pollutants compliance monitoring, u.s. envtl. protection agency, https://www.epa.gov/compliance/national-emission-standards352 indiana health law review [vol. 17:339 man-made sources including mobile sources like vehicles, and stationary sources like power plants.125 neshap standards are set for stationary sources emitting haps and are conducted in two separate phases.126 phase one is a “technologybased” standard where the epa sets emission standards based from sources of an industry group.127 these standards are considered “maximum achievable control technology” (mact) and are based on “emissions levels that are already being achieved by the controlled and low-emitting sources in an industry.”128 phase two is based off “residual risks” where the epa is required to assess the remaining health risks within eight years of setting the mact standard and more stringent standards are necessary if the current standards do not “protect public health with an ample margin of safety.”129 the requirements for these regulations took effect between 1999 and 2011, the epa projects that once the standards are fully implemented, they will reduce “annual air toxics emissions by about 1.7 million tons.”130 next, the epa is mandated to conduct compliance monitoring inspections of facilities under neshap, which includes: “[r]eviewing reports and records, [i]nterviewing facility personnel knowledgeable of the facility, [i]nspecting the processes that have emissions points subject to the standard sampling wastewater discharges . . . , [i]nspecting against design and work practice standards, [and] [r]eviewing leak detection and repair methods.”131 facilities must then perform an “initial performance test to demonstrate compliance” and must monitor emissions based on parameters from the initial performance test to demonstrate continued compliance.132 if a facility meets the caa’s definition of a “major source” then a state or regional office is required to perform a “full compliance evaluation” once every two years.133 a full compliance evaluation is just that, a “comprehensive evaluation of the compliance status of the facility.”134 specifically, it evaluates the regulated pollutants and emission units of the hazardous-air-pollutants-compliance-monitoring [https://perma.cc/n6xg-m2n3]. 125. hazardous air pollutants: sources and exposure, u.s. envtl. protection agency, https://www.epa.gov/haps/hazardous-air-pollutants-sources-and-exposure [https://perma.cc/zvk8sl8l]. 126. national emission standards for hazardous air pollutants compliance monitoring, supra note 124. 127. controlling hazardous air pollutants, supra note 88. 128. id. 129. id. 130. reducing emissions of hazardous air pollutants, u.s. envtl. protection agency, https://www.epa.gov/haps/reducing-emissions-hazardous-air-pollutants [https://perma.cc/34qdmqpq]. 131. national emission standards for hazardous air pollutants compliance monitoring, supra note 124. 132. id. 133. id. 134. how we monitor compliance, u.s. envtl. prot. agency, https://www.epa.gov/ compliance/how-we-monitor-compliance#pane-5 [https://perma.cc/58df-fdtp]. 2020] how indiana’s air pollution policies are impacting its citizens 353 facility, as well as the facilities ability to maintain continued compliance.135 b. indiana’s monitoring, designation, and implementation implementing effective air pollution controls would be too broad of a task for the epa to do for each state; therefore, the clean air act delegates some of the authority to the states.136 the caa allows and even encourages states to implement their own rules that abide by the caa so long as they meet the standards set by the epa.137 however, states are not subjected to only meet the standards set by the epa, the caa allows states to implement—more restrictive standards—as long as they do not “void any part of the federal regulation.”138 the same is true for local governments as well.139 in indiana, the state regulatory authority falls under the responsibility of the indiana department of environmental management (idem).140 1. indiana’s environmental rules board and permits indiana code (ic) 13-13-8 permits idem to create the environmental rules board (the “board”) which encompasses the broad task of adopting rules and regulations for all air pollution.141 the board specifically establish requirements for issuing air permits, which includes: (1) “[p]ermits to control or limit the emission of any contaminants into the atmosphere;” (2) “[p]ermits for the construction, installation, or modification of facilities, equipment, or devises to control or limit any discharge, emission, or disposal of contaminants into the air;” and (3) [p]ermits for the operation of facilities, equipment, or devices to control or limit the discharge, emission, or disposal of any contaminants into the environment.”142 in general, all sources that emit regulated air pollutants must apply for an air permit to do so.143 in order to receive a permit, applications submitted to idem must outline several factors, most important of which are 135. id. 136. delegation of clean air act authority, u.s. envtl. prot. agency, https://www.epa. gov/caa-permitting/delegation-clean-air-act-authority [https://perma.cc/rkx3-9ev6]. 137. ind. dep’t envtl. mgmt, supra note 41, at 3. 138. id. 139. id. at 3-4. 140. see ind. dep’t envtl. mgmt., air quality, in.gov, https://www.in.gov/idem/airquality/ [https://perma.cc/s8tv-cncz]. 141. ind. dep’t envtl. mgmt., environmental rules board, in.gov , https://www.in.gov/idem/ legal/2348.htm [https://perma.cc/qg9y-86ke]. 142. lucas d. martin, 5 ind. l. encyc. conserv. § 4 permit requirements, (westlaw 2019) (database updated jan. 2019). 143. ind. dep’t envtl. mgmt., air permit applications, in.gov, https://www.in.gov/idem/ airquality/2495.htm [https://perma.cc/d6ea-u8qw]. 354 indiana health law review [vol. 17:339 those used to calculate a source’s potential to emit (“pte”).144 idem calculates pte by taking the maximum amount of air pollution that each piece of equipment may emit if it operates at full capacity, without any pollution control equipment for twenty-four hours a day, 365 days a year.145 pte is then used to determine which air permit level the source will receive and the air pollution laws that will regulate it.146 a lower level permit will be issued directly to the source but higherlevel permits are subject to public comments and approval from the epa.147 air permits consists of five main sections. first, the source summary describes the type of industry the source pertains to and the equipment that will be regulated by the permit.148 the second section entails the general conditions that apply to all permitted sources.149 the third section includes the operating conditions that apply to all sources.150 the fourth entails the specific operating conditions for the source, including specific regulations and controls or limitations on emissions.151 finally, the last section is an incorporation of federal standards.152 2. indiana’s air quality modeling policies idem requires “air dispersion modeling” to demonstrate that a source will not violate air quality standards.153 indiana models its air quality policies in three separate categories, each complying with epa’s standards: (1) major source prevention of significant deterioration (psd) modeling, (2) non-attainment new source review (nsr) modeling, and (3) hazardous air pollutants (haps) emissions modeling.154 a. major source prevention of significant deterioration modeling “a source applying for a psd permit or modification is required to perform modeling when its potential to emit (pte) … is over the thresholds used to 144. see ind. dep’t envtl. mgmt., terms and definitions, in.gov, https://www.in.gov/idem/ airquality/2532.htm [https://perma.cc/d4ey-5p5m]. 145. id. 146. see id. 147. see ind. dep’t envtl. mgmt., air permitting timeframes and fees, in.gov, https://www. in.gov/idem/airquality/2648.htm [https://perma.cc/f3cy-66ul]. 148. ind. dep’t envtl. mgmt., air permitting background and terminology, in.gov, https://www.in.gov/idem/airquality/2649.htm [https://perma.cc/7zsk-vjcx]. 149. id. 150. see id. 151. id. 152. id. 153. ind. dep’t envtl. mgmt., modeling, in.gov, https://www.in.gov/idem/airquality/ 2375.htm [https://perma.cc/eg6q-3f29]. 154. ind. dep’t envtl. mgmt., air quality modeling policies 5 (2018), https://www.in. gov/idem/airquality/files/modeling_policies.pdf [https://perma.cc/vn42-z382]. 2020] how indiana’s air pollution policies are impacting its citizens 355 determine psd applicability.”155 depending on the source category, new sources must emit a pte greater than 100 or 250 tons per year to require psd modeling.156 for an already existing major source, any modification pertaining to a criteria air pollutant must exceed the “significant emission rate” distinguished in 326 iac 2-2-1 to make it a major modification.157 measurements are calculated in tons per year and include: • carbon monoxide—100 • nitrogen oxides—40 • sulfur dioxide—40 • fine particulate matter—10 • coarse particulate matter—15 • ozone—40158 next, idem determines the “significant impact level” of the new or modified source determined by the “significant net emissions increase” from the source.159 “once the significant net increase is determined, the proposed project is modeled to determine if it is above the [significant impact level].”160 “if the project does not exceed the significant impact levels” of any pollutant then “no further modeling is required.”161 if, however, the project does exceed significant impact levels then the “modeling impact analysis” must include: “the potential emissions after controls from the proposed new source or emissions from the existing source including the potential emissions from the proposed modification after controls; all other sources inside the [significant impact area]; and other distant sources taken from the naaqs inventory that may impact this [significant impact area].”162 hap analysis modeling is required for a source to retain a permit, but it further provides information to the public about the haps emission health impact on the area.163 modeling is based on major sources and major sources are considered any source that has a potential to emit any single hap by an excess of ten tons per year, or all haps combined by twenty-five tons per year.164 for modifications that exceed these standards, idem uses an approved epa dispersion model to “calculate off-site haps . . . concentrations in conjunction with toxicological information to conduct a cancer risk and hazard screening evaluation.”165 155. id. 156. id. at 7. 157. id. 158. id. 159. id. at 11. 160. id. 161. id. 162. id. 163. id. at 39. 164. id. at 38. 165. id at 39. 356 indiana health law review [vol. 17:339 idem also calculates the potential risk of cancer to the area’s inhabitants from the haps emissions.166 it does this by “multiplying the maximum, modeled annual concentration by its corresponding unit risk factor for carcinogenic haps” to estimate potential cancer risk for a single individual (i.e. cancer risk = annual concentration x unit risk factor).167 the result represents an “estimated individual cancer risk” based on the probability that a single person may develop cancer over the course of their lifetime due to exposure to the hap.168 it assumes that the individual has constant exposure to the hap throughout his life (24 hours a day, 365 days a year, for 70 years).169 idem considers any value above 1x10-6 to be a “level of concern” and will conduct another, more refined analysis.170 the “upper range of acceptability” by the epa is one in ten thousand (1.0e-04) cancer risks.171 iv. indiana should implement more stringent air pollution regulations for the amount of pollution being emitted by coal-fired power plants in southwest indiana, there has been very little nonattainment issues overall.172 in fact, indiana has repeatedly met attainment standards that have only increased since the caa was enacted.173 since 2005, out of nine southwest counties (including daviess, dubois, gibson, knox, pike, posey, spencer, vanderburgh, and warrick) seven counties have been in nonattainment for a pollutant, and only pike, vanderburgh, and warrick counties being in nonattainment for multiple pollutants.174 as of 2019 only two counties, daviess and pike, are in nonattainment, with both exceeding so2 levels.175 however, as is permissible under the caa, indiana has not adopted regulations that are more stringent than epa’s standards.176 due to the current nonattainment standards being a relative non-issue and the fact that indiana’s citizens still incur adverse health effects from air pollution, indiana should adopt regulations that impose stricter emission 166. id. at 40. 167. id. 168. id. 169. id. 170. id. 171. id. 172. see ind. dep’t envtl. mgmt., current and historical list of nonattainment areas by county, https://www.in.gov/idem/airquality/files/nonattainment_county_list.pdf [https://perma.cc/hjd6-4xtk]. 173. see id. 174. ind. nonattainment/maintenance status for each county by year for all criteria pollutants, u.s. envtl. prot. agency, https://www3.epa.gov/airquality/greenbook/anayo_in.html [https://perma.cc/2zzz-6dgn]. 175. id. 176. see ind. dep’t envtl. mgmt., nonattainment status for ind. counties, in.gov, https://www.in.gov/idem/airquality/2339.htm [https://perma.cc/ut9l-l86r]. 2020] how indiana’s air pollution policies are impacting its citizens 357 standards. a. indiana compared to states with more stringent regulations 1. california california is one of the most well-known states that has enacted stricter emission standards than the epa. it did this through the development of the california air resources board (“carb”). carb consists of sixteen members that represent various components of air pollution regulation.177 carb regulates air quality as part of a three-tiered approach: (1) the epa setting national emission standards, (2) carb setting the state’s own stricter standards, and (3) thirty-five “local air pollution control districts regulat[ing] emissions from business and stationary facilities.”178 carb sets california’s emission standards based on multiple factors including: (1) levels that “protect those at greatest risk,” (2) “identifying pollutants that pose the greatest health risks,” (3) measuring progress, (4) determining solutions based on “the best available science and technology,” and (5) studying the “costs and benefits of pollution controls.”179 further, carb considers public participation by holding monthly public meetings and by consulting with industry, scientific, and health experts.180 carb’s standards, known as caaqs, are for the same six criteria air pollutants as the naaqs, including four additional ones (which will not be discussed), and are as follows (with the epa’s and indiana’s in parenthesis): co: • 8 hours—9 ppm (in 9 ppm) • 1 hour—20 ppm (in 35 ppm) pb: • 30-day average—1.5 µg/m3 (in on a rolling three-month average at 0.15 µg/m3) no2: • 1-hour—0.18 ppm (in 100 ppb) • annual—0.030 ppm (in 0.053 ppm) 177. the california air resources board, cal. air resources board, https://ww2.arb.ca. gov/about [https://perma.cc/cn62-dmgf] (members consists of five who serve on local air districts, four experts in fields that shape air quality rules, two public members, two members who represent environmental justice communities, two nonvoting members appointed for legislative oversight, and one fulltime member that serves as the chair). 178. id. 179. id. 180. id. 358 indiana health law review [vol. 17:339 ozone: • 1-hour—0.09 ppm (in no standard) • 8-hour—0.070 ppm (in 0.070 ppm) pm2.5: • 24-hour—no standard (in 35 µg/m3) • annual—12 µg/m3 (in 12 µg/m3) pm10: • 24-hour—50 µg/m3 (in 150 µg/m3) • annual—20 µg/m3 (in no standard) so2: • 1-hour—0.25 ppm (in 75 ppb) • 3-hour—no standard (in 0.5 ppm (secondary)) • 24-hour—0.04 ppm (in 0.14 ppm) • annual—no standard (in 0.030 ppm)181 still, carb estimates that over “90 percent of californians breathe unhealthy levels of one or more air pollutants during some part of the year.”182 unlike indiana though, coal was never a huge factor for energy consumption in california.183 however, stricter emission standards have caused coal to drop even lower than its already low level.184 for example, in 2007, the “total megawatt hours” attributed to coal was at a mere one percent, by 2015 it dropped even further to two-tenths of one percent.185 secondly, the electric power consumption by coal dropped by ninety-six percent within those same years.186 besides the caaqs, other determining factors for decreasing coal use includes lower natural gas prices and california’s overall goal for promoting renewable energy.187 therefore, this correlation shows that if indiana would adopt stricter emission standards, then utility companies would likely transition to alternate energy source. 181. ambient air quality standards, cal. air resources board (may 4, 2016), https://www.arb.ca.gov/research/aaqs/aaqs2.pdf?_ga=2.134284849.1327462312.15504445891717364413.1536618703 [https://perma.cc/3zcq-ycn9]. nonattainment status for ind. counties, supra note 176. 182. common air pollutants, cal. air resources board, https://ww2.arb.ca.gov/resources/ common-air-pollutants [https://perma.cc/rj29-hw6w]. 183. see rob nikolewski, california’s coal collapse, san diego union-trib. (may 5, 2016), https://www.sandiegouniontribune.com/sdut-california-coal-collapse-2016may05-story.html [https://perma.cc/5m5w-4ysx]. 184. id. 185. id. 186. id. 187. id. 2020] how indiana’s air pollution policies are impacting its citizens 359 2. north carolina unlike california, and more similar to indiana, north carolina has relied on coal and manufacturing to develop its society and boost its economy.188 however, due to increasing pollution issues by outdated power plants, in 2002 north carolina enacted the clean smokestacks act (csa), which is a regulation that specifically targeted a reduction in emissions of no2 and so2 from coal-fired power plants.189 the csa established a maximum annual amount of emissions that coal-fired power plants could emit for those two pollutants; specifically, when compared to 1998 emission levels, requiring a “permanent” reduction of 77% in no2 by 2009, and 73% of so2 by 2013.190 the goal of these emission standards were to either require the “modernization or retirement of all forty-five coal-fired generating units . . . at their fourteen sites in north carolina.”191 the csa was successful in achieving its primary objectives, by 2012 no2 emissions were reduced by 84% and so2 emissions by 89%.192 it forced duke energy—one of the super polluting utility companies in indiana—to “retire[] or schedule[] retirement of fifteen of its twenty-eight coal-fired power plants” and it modernized the emission process for the rest.193 studies have been conducted over the health and economic effectiveness of north carolina’s csa. the international journal of environmental science and technology conducted one such study based on the health impact that csa had on north carolina’s residents from 2002-2012.194 the study did so by comparing “observed pm2.5 sulfate concentrations to so2 emissions over time and examin[ing] changes in the public health burden due to coal-fired power plant emissions . . . .”195 this study reinforces the data by confirming that so2 emissions were reduced drastically by 2012, stating that the “annual power plant so2 emissions decreased from 459.7 thousand tons to 53.5 thousand tons.”196 it further found that the emission rate for north carolina’s piedmont region (the region that holds most of the state’s coal-fired power plants), comparable to 188. see the coal institute, coal inst., http://thecoalinstitute.org/ [https://perma.cc/2sg2wuz4]. 189. richard n. l. andrews, state environmental policy innovations: north carolina’s clean smokestacks act, 43 envtl. l. rev. syndicate 881, 883 (2013), https://law.lclark.edu/live/files/ 16063-43-4andrews [https://perma.cc/vg6s-8fkk]. 190. id. 191. id. 192. id. 193. id. 194. ya-ru li & jacqueline macdonald gibson, health and air quality benefits of policies to reduce coal-fired power plant emissions: a case study in north carolina, 48 envtl. sci. & tech. 10019 (2014). 195. id. at 10020 (pm2.5 sulfate concentrations is a “major component” of pm2.5 found to be mainly emitted from coal-fired power plants). 196. id. at 10022. 360 indiana health law review [vol. 17:339 southwest indiana, decreased at a significantly faster rate than the rest of north carolina and that overall, north carolina’s emissions decreased significantly faster than surrounding states that had not adopted more stringent emission standards.197 finally, a reduction in so2 also correlated to a reduction in pm2.5 sulfate concentrations and again the greatest area of impact was north carolina’s piedmont region.198 from 2002-2012, pm2.5 sulfate concentration decreased from 4.2 µg/m3 to 1.7 µg/m3 which is a decrease of sixty percent.199 the study suggests that the reduction of so2 and pm2.5 sulfate concentration is attributable to a reduction of premature deaths in north carolina over the same period.200 specifically, “all-cause deaths” from pm2.5 sulfate decreased by 63% from 20022012 and resulted in the prevention of 1,700 premature deaths—or, if “pm2.5 sulfate [emissions] had remained the same in 2012 as in 2002, then an additional 1700 deaths would have been expected.”201 overall, this study argues that the csa has had multiple significant findings and benefits.202 besides preventing 1700 premature deaths in north carolina, the empirical data shows (as could be reasonably hypothesized) that the csa reduced coal-fired power plant emissions quicker and more effectively than what federal implementation could have done alone—in other words, more stringent emission standards equals a greater reduction in that pollutant.203 the study supports this conclusion by comparing the rate of reduction between north carolina and its neighboring states, which did not adopt stricter emission policies—finding that the average rate of reduction for southeastern states fell at about 13.6% annually, while north carolina’s reduction reached 20.3% annually.204 next, the study argues that the csa possibly did not only benefit north carolina, but it also benefited surrounding states.205 it is estimated that the average distance that so2 travels in the southeast is anywhere from 115 to 220 kilometers.206 a reduction of so2 emissions traveling through the air has been shown to cause a reduction in pm2.5 sulfates as well, this is especially relevant when paired with the study’s analysis that “direct reductions from local sources appear to be effective in reducing pm2.5 sulfate levels both locally and in surrounding areas.”207 another study also found similar health results when they analyzed the csa. the international journal of copd “analyzed the trends of emphysema, asthma, and pneumonia mortality and changes of the levels of ozone, sulfur dioxide (so2), nitrogen dioxide (no2), carbon monoxide (co), and particulate matter 197. id. 198. id. 199. id. 200. id. at 10024. 201. id. 202. see id. at 10025. 203. id. 204. id. 205. id. 206. id. 207. id. at 10022, 10025. 2020] how indiana’s air pollution policies are impacting its citizens 361 (pm2.5 and pm10) . . . .” 208 this study found that lower levels of so2, co, and pm10 resulted in a decline in emphysema, asthma, and pneumonia deaths.209 it further concluded that improved air quality by decreasing levels of so2, co, and pm10 in the air “contributed to the improved respiratory health of the north carolina population.”210 however, the csa was not only beneficial for north carolina’s public health, but it also created solutions to potential problems in the energy sector too. utilities tend to favor “regulatory certainty” when it comes to compliance because plans, permits, construction and operating lifetimes tend to span over a period of decades for a facility.211 however, because of frequent policy changes at the federal level and actions by the courts “often creates unpredictable and short compliance timelines for environmental regulation.”212 therefore, since the csa was enacted before federally mandated emission standards like the cross-state air pollution rule (csapr) and the mercury air toxics standard (mats), the csa created four benefits for utility companies and consumers.213 first, by the time that federally mandated emission standards are increased, utility companies are already in compliance with the new standards; which reduces the need for a sudden upgrade in emission technology.214 this becomes more important through the second benefit, which the study argues, that because the csa was enacted before new federal emission standards, it created a longer compliance period; therefore, utility companies had more time to adjust to the new standards and could spread out consumer costs over a greater period of time.215 the third benefit distinguished by the study, again discusses the health benefits of reduced emissions, specifically stating that the health benefits are “an order of magnitude greater than potential increases in costs for ratepayers that may result from clean smokestacks.216 finally, the csa “likely reduced other environmental compliance costs”217 by avoiding compliance costs associated with naaqs.218 the study concludes that it is possible (however, difficult) for a state to adopt 208. julia kravchenko et al., long-term dynamics of death rates of emphysema, asthma, and pneumonia and improving air quality, 9 int’l j. chronic obstructive pulmonary disease 613, 613 (2014). 209. id. 210. id. at 623. 211. david hoppock et al., benefits of early state action in environmental regulation of electric utilities: north carolina’s clean smokestacks act 1-25, 24 (nicholas inst. for envtl. policy sols., working paper no. 12-05, 2012). 212. id. 213. id. at 3. 214. id. 215. id. 216. id. 217. id. 218. id. at 25. 362 indiana health law review [vol. 17:339 policies that benefit both utilities and environmental objectives.219 to do so, a state must incorporate “[c]ollaborative thinking about future risks and interdependencies between state utility policy, environmental quality, and state energy policy goals” in order to avoid inconsistencies within the energy sector while also improving the “quality of life for state citizens.”220 b. health statistics the primary health conditions related to coal-fired power plant emissions include heart disease, lung disease, and cancer.221 this section will first discuss and compare indiana health statistics compared to california and north carolina. secondly, it will compare evansville to fort wayne, indiana. 1. indiana’s health compared california and north carolina the three main causes of death in indiana include heart disease, cancer, and chronic lower respiratory disease.222 according to the american college of cardiology (college), air pollution can trigger a heart attack or stroke by reducing the heart’s ability to pump blood.223 pm contributes the highest risk to triggering a cardiovascular event.224 the college recommends exercise to lower one’s risk, however, it cautions doing so while in urban settings with high levels of traffic or in industrial areas.225 the centers for disease control and preventions (center) keeps statistics for health-related deaths in all states and includes an age-adjusted rate for population comparison.226 according to the center, heart disease was the leading cause of death for indiana residents in 2016 at 13,952 deaths.227 this puts indiana at an adjusted rate of 180.6, which is ranked as the thirteenth most in the us, and 15.1 points higher than the us average of 165.5.228 in comparison, california had 61,573 heart disease related deaths in 2016, at an adjusted rate of 143.1, ranking it fortieth in the country.229 further, north carolina had 18,266 heart disease 219. id. 220. id. 221. power plants, u.s. nat’l lib. med., (may 31, 2017) https://toxtown.nlm.nih.gov/ sources-of-exposure/power-plants [https://perma.cc/jwt9-8wj6]. 222. stats of the state of indiana, ctrs. for disease control & prevention, https://www.cdc.gov/nchs/pressroom/states/indiana/indiana.htm [https://perma.cc/5gpw-hjsm]. 223. envtl. prot. agency, heart disease, stroke, and outdoor air pollution, https:www3.epa.gov/airnow/heartflyer.pdf [https://perma.cc/3hfv-x9kh]. 224. id. 225. id. 226. see stats of the state of indiana, supra note 222. 227. id. 228. id. 229. stats of the state of california, ctrs. for disease control & prevention, https://www.cdc.gov/nchs/pressroom/states/california/california.htm [https://perma.cc/m2s52020] how indiana’s air pollution policies are impacting its citizens 363 related deaths, with an adjusted rating of 155.8, ranking it twenty-eighth in the country.230 just under heart disease, follows cancer, which accumulated 13,424 deaths for indiana in 2016.231 this corresponds to an adjusted rate of 172.5, ranked ninth in the us and 16.7 points above the country’s average of 155.8.232 cancer is also the second highest leading cause of death in california in 2016, at 59,515 deaths its adjusted rate falls at 139.7 and ranked forty-fifth in the country.233 cancer was the leading cause of death in north carolina in 2016, taking 19,523 lives, its adjusted rate falls at 161.6 and corresponds to the nineteenth highest rating in the country.234 finally, chronic lower respiratory disease took 4,214 indiana lives in 2016 with an adjusted rate of 54.6, ranking it ninth in the country and above the countries average of 40.6 by 14 points.235 chronic lower respiratory disease was california’s fifth leading cause of death at 13,710 deaths in 2016, adjusted to 32.6 points it is ranked forty-third in the country.236 finally, north carolina lost 5,311 lives to chronic lower respiratory disease, with an adjusted rate of 44.8 and ranking it twenty-second in the country.237 2. vanderburgh county v. allen county this subsection will compare indiana’s vanderburgh county (evansville) to allen county which is located in the northeast corner of the state and holds indiana’s second largest city, fort wayne.238 health comparisons are based off of indiana indicators, an interactive website that allows users to compare health statistics between specific counties in indiana, with the data being updated with the most recent information.239 although other factors contribute to the public health of an area, this data shows that vanderburgh county, while being stuck bfjc]. 230. stats of the state of north carolina, ctrs. for disease control & prevention, h t t ps :/ /w w w .cdc .gov/n ch s /press room /s t a t es /n or th carolina/north ca ro lin a .h tm [https://perma.cc/r7wm-7mry]. 231. stats of the state of indiana, supra note 222. 232. id. 233. stats of the state of california, supra note 229. 234. stats of the state of north carolina, supra note 230. 235. stats of the state of indiana, supra note 222. 236. stats of the state of california, supra note 229. 237. stats of the state of north carolina, supra note 230. 238. indiana, statsindiana, http://www.stats.indiana.edu/profiles/profiles.asp?scope_ choice=a&county_changer=18000 [https://perma.cc/8td4-anxu] (showing that fort wayne has a population of approximately 268,000 while evansville is ranked indiana’s third largest city with a population of about 118,000). 239. health maps, indicators, http://indianaindicators.org/dash/map.aspx [https://perma.cc/ l4f3-6y9w]. 364 indiana health law review [vol. 17:339 between four super polluters,240 is overall less healthy than allen county which boasts a larger population and therefore a higher number of mobile sources. to continue the health-based risks most common with air pollution, comparisons will be drawn from cases of asthma, chronic lower respiratory disease, heart disease and cancer. to begin, the data showed asthma emergency room (er) visits for adults per a 10,000-population basis and found that vanderburgh county recorded 68.8 cases while allen county recorded 50.6.241 this number increased for children (ages five to seventeen) where vanderburgh county recorded 88.8 cases while allen county recorded 54.9 cases.242 inversely, allen county recorded a higher ratio of asthma hospitalizations for adults at 12.5 cases and 7.3 cases for children while vanderburgh county recorded 10.7 cases for adults243 and 6.3 for children.244 next, is chronic lower respiratory disease deaths per a 100,000population basis and found that allen county recorded 41.9 cases while vanderburgh county recorded 77.3 cases.245 vanderburgh county is also higher for heart disease cases recording 107.3 heart disease hospitalizations per 10,000 population while allen county recorded 81.9 cases;246 and for heart disease deaths where vanderburgh county recorded slightly more at 171.2 cases per 100,000 population basis while allen county recorded 170 cases.247 further, cancer deaths were also higher in vanderburgh county, which recorded 194 deaths per 100,000 population basis, while allen county recorded 172.2 deaths.248 finally, vanderburgh county also recorded higher rates of new cancer cases per 100,000 population basis, 475.1 to 424.6,249 new lung cancer cases, 79.2 to 61.7,250 and lung cancer deaths, 56.9 to 46.8.251 the data also shows that adults in vanderburgh county report a higher percentage of “poor to fair health” at 20.0% while allen county adults reported in at 15.0%.252 this also correlates to the rate of premature deaths (ages 75 and below) in each county with vanderburgh reporting 439 deaths and allen county reporting 385 deaths.253 however, as mentioned above, these results could be impacted by other factors. for example, adults in vanderburgh county reported a higher percentage of adults that lacked physical activity at 27% while allen county reported 22% of 240. hopkins, supra note 2. 241. health maps, supra note 239, at asthma emergency dep’t visits per 10k. 242. id. at child asthma emergency dep’t visits per 10k. 243. id. at asthma hospitalizations per 10k. 244. id. at child asthma hospitalizations per 10k. 245. id. at chronic lower respiratory disease deaths per 100k. 246. id. at heart disease hospitalizations per 10k. 247. id. at heart disease deaths per 100k. 248. id. at cancer deaths per 100k. 249. id. at new cancer cases per 100k. 250. id. at new lung cancer cases per 100k. 251. id. at lung cancer deaths per 100k. 252. id. at adults reporting poor to fair health. 253. id. at premature deaths (aged 75 and under) per 100k. 2020] how indiana’s air pollution policies are impacting its citizens 365 adults.254 further, the rate of adults who reported to smoke was also higher in vanderburgh county at 21%, with allen county reporting 20% of its adults as smokers.255 although, these factors contribute to public health, they do not rule out the fact that millions of tons of toxic pollutants by coal-fired power plants also impacts public health.256 v. conclusion although coal has been a reliable and cheap resource, the public health benefits of implementing more stringent air pollution emission standards outweigh its economic benefit. proof of this can be seen by comparing indiana’s health statistics with other states who have implemented more stringent standards, like california and north carolina, and by comparing indiana to national averages. moreover, it is especially beneficial to look at the impact of north carolina’s clean smokestacks act. north carolina is similar to indiana, in that it hosts a multitude of coal-fired power plants.257 through the csa, north carolina was able to lower emission levels which benefited public health by forcing the shutdown of old coal-fired power plants.258 the csa has been contributed to saving up to 1700 premature deaths alone.259 the csa has also been argued to have benefited north carolina economically by granting longer compliance periods for utilities to make adjustments and to also spread out any increased compliance costs to its customers over a longer period of time.260 this same theory could also be used to argue for a transition to renewable energy and leaving coal behind for good. besides the positive public health and environmental impacts from renewable energy sources, like solar and wind power, renewable energy sources produce jobs. unlike fossil fuel jobs, “which are typically mechanized and capital intensive,” renewable energy jobs are more labor intensive.261 which means, that, “on average, more jobs are created for each unit of electricity generated from renewable sources than from fossil fuels.”262 in 2016, wind energy employed over 100,000 full-time jobs while solar energy created even more at over 260,000 jobs, 254. id. at adults reporting physical inactivity. 255. id. at adults who smoke. 256. see hopkins, supra note 2. 257. see li & gibson, supra note 194, at 10019 (discussing north carolina’s piedmont region). 258. see andrews, supra note 189, at 883. 259. li & gibson, supra note 194, at 10025. 260. hoppock, supra note 211, at 3. 261. benefits of renewable energy use, union concerned scientists (dec. 20, 2017) https://www.ucsusa.org/clean-energy/renewable-energy/public-benefits-of-renewable-power#bftoc-3 [https://perma.cc/rd3u-p6y9]. 262. id. 366 indiana health law review [vol. 17:339 and to “contrast, the entire coal industry employed 160,000 people.”263 the renewable energy sector needs employment that includes manufacturing, development, transportation and maintenance among others.264 this resulted in more than 500 factories manufacturing parts for wind turbines in the united states in 2016, which “represented $13.0 billion in investments.”265 this, in turn, would also benefit indiana and local governments by replacing income from property and income taxes from coal mines with those taxes from a greater number of residents and facilities.266 this is just a small analysis of the economic benefits of renewable energy, but with other states and countries throughout the world making the transition, it would be beneficial for indiana to do the same, and do so with increased economic, public health, and environmental benefits. 263. id. 264. id. 265. id. 266. id. indiana health law review volume xviii 2021 number 2 articles residential eviction and public housing: covid-19 and beyond* anne kat alexander** i. introduction this article provides an account and analysis of the eviction-reducing public health measures taken during the covid-19 pandemic in the united states, adding to the urgent and growing body of research that seeks both to capture a description of the current situation and press for best practices to be implemented more widely.1 i gave the panel presentation that this article accompanies approximately six weeks before this writing, and already much has changed with * this article was completed on november 30, 2020. ** researcher in the eviction lab at princeton university. i am grateful to the organizers of the 2020 indiana health law review symposium for the invitation to speak on the topic of pandemic eviction and housing policy and to all symposium attendees for the attention to this crucial topic. i thank lillian leung and katie krywokulski for their comments after reading this article and extend a thousand thanks to sarah lee for research assistance. finally, my thanks also to professors matthew desmond and emily benfer for guidance and mentorship throughout the process of researching eviction moratoria during the pandemic. 1. e.g., anne kat alexander & sarah lee, preliminary analysis: a year of eviction moratoria, eviction lab (mar. 29, 2021), https://evictionlab.org/one-year-of-eviction-moratoria/ [https://perma.cc/3thf-4yv6]; emily a. benfer et al., health justice strategies to combat the pandemic: eliminating discrimination, poverty, and health disparities during and after covid19, 19 yale j. health pol’y l. & ethics 122 (2020); kathryn m. leifheit et al., expiring eviction moratoriums and covid-19 incidence and mortality 5 (nov. 30, 2020) (unpublished manuscript) (on file with the indiana health law review); emily a. benfer et al., eviction, health inequity, and the spread of covid-19: housing policy as a primary pandemic mitigation strategy, 98 j. urb. health 1 (2021); renee louis et al., preliminary analysis: eviction claim amounts during the covid-19 pandemic, eviction lab (aug. 27, 2020), https://evictionlab.org/ covid-eviction-claims [https://perma.cc/nv2y-turs]; peter hepburn & renee louis, preliminary analysis: shifts in eviction filings from the cares act to the cdc order, eviction lab (sept. 22, 2020), https://evictionlab.org/shifts-in-eviction-filings-from-cares-act-to-cdc-order [https:// perma.cc/6jk4-gqmr]; peter hepburn & renee louis, preliminary analysis: eviction filings during and after local eviction moratoria, eviction lab (nov. 15, 2020), https://evictionlab.org/ moratoria-and-filings/ [https://perma.cc/4udl-qtzz] [hereinafter eviction filings during and after local eviction moratoria]. 244 indiana health law review [vol. 18:243 respect to housing policy, infection counts, and the pandemic as a whole; even more will change before this article goes to press. during the time between my presentation and this writing, americans elected a new president; that new president, joe biden, will be inaugurated on january 20, 2020. before inauguration day, the national eviction moratorium put in place to curb the spread of covid-19 by the centers for disease control and prevention (“cdc”) is scheduled to expire.2 the past several weeks and months have seen governors, state supreme courts, and legislatures implement extraordinary measures to keep people housed. the policy landscape shifts like sand underfoot, but reviewing those early, remarkable emergency orders provides a spark of hope that the shifts can move in a direction that promotes housing stability and, consequently, improved public health. in this article, i combine an early analysis of covid-19 emergency housing policies put in place during the ongoing pandemic with a look to the future and some of the options available to policymakers working to create a more stable rental housing market than the one that existed prior to the health and economic crisis. i aim to answer the following questions, which are relevant both at the present moment and in the months and years to come: what did we do about eviction during this once-in-a-generation pandemic? why did we do it? where did we go wrong? and, what should we do next? in section ii, i begin with a brief overview of the problem of eviction, its definition and characteristics, and what it has to do with health. eviction is associated with many harms to tenants and falls within two main categories: (1) harms having to do with the acute crisis of removal from one’s home and (2) long-term harms having to do with the “scarlet e” that an eviction filing leaves on a tenant’s rental history,3 which prevents the tenant from accessing healthy housing later.4 section iii examines covid-19 rental housing policy responses in general, including social distancing in courts, financial assistance, and eviction moratoria. remarkably, forty-three states and the district of columbia implemented some form of emergency anti-eviction policy other than or in addition to financial assistance.5 in this section, i outline the contours of what policies were 2. temporary halt in residential evictions to prevent the further spread of covid-19, 85 fed. reg. 55,292 (sept. 4, 2020). 3. scarlet e: unmasking america’s eviction crisis, wnyc studios (june 6, 2020), https://www.wnycstudios.org/podcasts/otm/scarlet-e-unmasking-americas-eviction-crisis [https://perma.cc/fu8v-pr6g]. 4. see generally rudy kleysteuber, tenant screening thirty years later: a statutory proposal to protect public records, 116 yale l.j. 1344 (2007); allyson e. gold, no home for justice: how eviction perpetuates health inequality among low-income tenants, 24 geo. j. poverty l. pol’y 59 (2016); katelyn polk, screened out of housing: the impact of misleading tenant screening reports and the potential for criminal expungement as a model for effectively sealing evictions, 15 nw. j.l. & soc. pol’y 338 (2020); matthew desmond, eviction and the reproduction of urban poverty, 118 am. j. soc. 88, 118 (2012). 5. emily benfer et al., covid-19 eviction moratoria & housing policy: federal (cdc), 2021] residential eviction and public housing 245 implemented, thus proving to be possible, in 2020. section iii also discusses the goals of covid-19 rental housing policy and flaws in policies and programs that prevent the achievement of these goals. i pay particular attention to four types of flaws: (1) intervention that targets an action too late in the eviction process; (2) intervention that only applies to subsets of renters or types of housing; (3) intervention that requires action by tenants; and (4) intervention that postpones, rather than eliminates, risk of eviction. three policy regimes are discussed in greater detail in section iv: the responses of massachusetts and austin, texas, which stand out as exemplary among responses from states, localities, and the federal government’s response in the coronavirus aid, relief, and economic security act (“cares act”) and the cdc’s eviction moratorium. i conclude with notes about court actions in section v and thoughts on how, in the wake of strong anti-eviction measures during a crisis, we might move forward with creating a housing policy regime that supports public health following the pandemic. key to any discussion about eviction in the united states is understanding that the hardships caused by housing insecurity are not distributed evenly throughout the american population. systemic racism has denied black americans the key wealth-building activity of homeownership for centuries. whereas more than three in four non-hispanic white families own their homes, fewer than half of all black families are homeowners.6 this difference in homeownership contributes to the fact that the median white family in america has ten times the wealth of the median black family.7 the simple demographic truth that a higher proportion of nonwhite than white families are renters means that, by definition, nonwhite and especially black american households, as a population, will be more exposed to eviction and its harms than white american households. further, research into the demographic characteristics of evicted tenants and distribution of eviction cases within cities demonstrates that black households8 and black neighborhoods9 experience this form of housing instability state, commonwealth, and territory, google, http://bit.ly/covid19evictionfreezeus [https:// perma.cc/p2kr-ecgz] (last visited mar. 28, 2021) [hereinafter covid-19 eviction moratoria & housing policy]. 6. quarterly residential vacancies and homeownership, fourth quarter 2020, u.s. census bureau (oct. 27, 2020), https://www.census.gov/housing/hvs/files/currenthvspress.pdf [https://perma.cc/5ksa-wrf3]. 7. christopher ingraham, a new explanation for the stubborn persistence of the racial wealth gap, wash. post (mar. 14, 2019), https://www.washingtonpost.com/us-policy/2019/03/14/ new-explanation-stubborn-persistence-racial-wealth-gap/ [https://perma.cc/pyv9-bdfm]. 8. sophie beiers et al., clearing the record: how eviction sealing laws can advance housing access for women of color, aclu (jan. 10 2020), https://www.aclu.org/news/racialjustice/clearing-the-record-how-eviction-sealing-laws-can-advance-housing-access-for-women-ofcolor/ [https://perma.cc/8wd9-4t2t]; timothy a. thomas et al., the state of evictions: results from the university of washington evictions project § 4.3 (2019), https:// evictions.study/washington/index.html [https://perma.cc/6lnf-ead3] [hereinafter the state of evictions]; tim thomas et al., baltimore eviction map, evictions study (may 8, 2020), 246 indiana health law review [vol. 18:243 at a rate disproportionate to their share of the renting population. these racial inequities will be even more pronounced during the covid-19 pandemic and corresponding economic crisis. the [cdc has] estimated that covid-19 case and hospitalization rates are at least 2.5 and 4.5 times higher, respectively, among black, hispanic, and native american populations than among [w]hite populations. black individuals have died from covid-19 at more than twice the rate as [w]hite individuals.10 at the same time, unemployment rates during the crisis are higher for black and hispanic workers than white and non-hispanic workers.11 this article considers eviction as a public health issue, but one should keep in mind that this public health burden is particularly and disproportionately borne by black americans. ii. what does eviction have to do with health? the covid-19 pandemic resulted in an unprecedented health and economic crisis in the united states. still, it may not be immediately evident why a ban on evictions, accompanied by rental assistance (i.e., economic relief for landlords to recoup lost rental payments), makes sense as a public health response alongside measures like stay-at-home orders, limits on public gatherings, facial covering mandates, or orders designed to increase the supply of personal protective equipment. eviction bans appear logical as part of the economic response, alongside measures like expanded unemployment insurance, but an immediate link may not be clear between eviction and public health. to see the link, one must consider the fundamental role that housing plays in health, both in the daily lives of renters prior to the covid-19 pandemic and during the acute crisis of the pandemic. a. the eviction process and characteristics: common, quick, and traumatic legal eviction is the court-ordered removal of a tenant from their home, returning exclusive possession of the rental property to the owner (i.e., landlord). other forced moves include rental units being condemned; foreclosures (i.e., when a lending institution recovers possession of a home from an owner); socalled “self-help,” “illegal,” or “informal” evictions, which are all terms used to describe when a landlord takes an illegal action to recover possession of the rental unit (e.g., cutting electricity or heat to an apartment or changing the locks); or what is sometimes called a “no cause” eviction (i.e., when a landlord declines to https://evictions.study/maryland/report/baltimore.html [https://perma.cc/9upn-u87e]. 9. desmond, supra note 4. 10. rohan khazanchi et al., racism, not race, drives inequity across the covid-19 continuum, 3 jama network open art. e2019933 (2020), at 1. 11. gene falk et al., cong. research serv., r46554, unemployment rates during the covid-19 pandemic: in brief 8 (2020), https://fas.org/sgp/crs/misc/r46554.pdf [https:// perma.cc/cz7m-f2g7]. 2021] residential eviction and public housing 247 renew a lease or raises the rent above what the tenant can afford when renewing the lease, thus causing the tenant to need to move). all of these forced moves contribute to housing insecurity and deserve attention from scholars, policymakers, and the public. however, this article focuses narrowly on the forced move that comes about after an eviction judgment is given by a court. the word “eviction” in this article refers to a forced move at any point in the legal eviction process. in 2016, landlords filed an estimated 3.6 million eviction cases in courts across the united states, the equivalent of seven cases per minute.12 more eviction cases are filed in a typical year than there were foreclosure starts at the height of the great recession.13 this eviction figure comes not from a government entity tracking the number of eviction cases but from the eviction lab at princeton university because the federal government does not keep track of this measure of housing insecurity, nor do all states. of course, not all of the estimated 3.6 million cases filed resulted in the tenant being forced to leave their home. how many of these filings eventually become evictions is an open question. the eviction lab cannot clearly determine the legal outcome of every case. such can remain unclear even when the case disposition information is recorded by the court. for example, some court systems list case outcomes with opaque labels like “disposed.”14 and even when the lab can observe a non-opaque outcome on a case, the legal decision does not always comport with the situation on the ground (i.e., whether or not a forced move occurred). perhaps a tenant, believing that their case is hopeless, leaves before a judgment is entered, in turn causing the landlord to withdraw the case. in that situation, the “dismissed” case disposition might represent a forced move. other times, a court might enter a judgment for the landlord, but the tenant does not leave the unit. a court might enter a judgment for the landlord even in settled cases or cases with other outcomes.15 we observe an example of the latter case in what the eviction lab calls serial cases or repeated filings and eviction judgments against the same tenant at the same address. these serial cases were first noticed by the eviction lab while 12. on the brink of homelessness: how the affordable housing crisis and the gentrification of america is leaving families vulnerable: hearing on h.r.1856 and h.r.5187 before the h. comm. on fin. servs., 116th cong. 3 (2020) (statement of matthew desmond, maurice p. during professor of sociology & principal investigator, eviction lab, princeton university). 13. lynn adler, u.s. 2009 foreclosures shatter record despite aid, reuters (jan. 14, 2010), https://www.reuters.com/article/us-usa-housing-foreclosures/u-s-2009-foreclosures-shatterrecord-despite-aid-idustre60d0lz20100114 [https://perma.cc/s62c-sj3h]. 14. adam porton et al., inaccuracies in eviction records: implications for renters and researchers, 31 housing pol’y debate (forthcoming 2021). 15. esme caramello & annette duke, the misuse of masscourts as a free tenant screening device, bos. bar j. (oct. 21, 2015), https://bostonbarjournal.com/2015/10/21/the-misuse-ofmasscourts-as-a-free-tenant-screening-device/ [https://perma.cc/grt6-p6pk]; mary b. spector, tenants’ rights, procedural wrongs: the summary eviction and the need for reform, 46 wayne l. rev. 135, 185 (2000). 248 indiana health law review [vol. 18:243 cleaning administrative court data from south carolina.16 at first, it was not clear if these cases were real or mistakes, perhaps duplicates. after all, if a tenant was filed against and ordered by the court to leave in june, how could the “evicted” tenant be evicted again in july and august? but, calls to court clerks and legal aid lawyers in south carolina revealed that indeed these situations were common for many tenants, and the cases were each real.17 some landlords and property managers in south carolina, maryland, and other states, cities, and towns with high serial eviction filing rates file eviction cases as a matter of course when a tenant first falls behind on rent. these cases are not uniformly dismissed every time a landlord allows a tenant to stay (e.g., because a tenant comes up with the late rent or the landlord and tenant agree to a payment plan for the debt). sometimes, these cases are marked as judgments for plaintiff.18 the presence of serial cases thus debunks the notion that tenants uniformly leave in cases that are tagged in the court’s digital record-keeping system as “judgment in favor of plaintiff.”19 one can expect the rate at which a judgment for plaintiff results in a forced move (i.e., an eviction) to vary from state to state and to be closer to 100% in states with low serial filing rates.20 as such, attempts to accurately determine the number of evictions that take place in the united states encounter three major hurdles. first, the information is not tracked in a centralized location, sometimes not even at the state level. second, the information from court records can be opaque or functionally nonexistent, even when one can obtain it. third, a distance exists between the recorded decision of the court and the reality. based on what evidence is available, it is safe to say that millions of american households each year are 16. matthew desmond et al., eviction lab national database: version 1.0, at 27 (2018), https://evictionlab.org/docs/eviction%20lab%20methodology%20report.pdf [https:// perma.cc/xbl4-4esm]. 17. id. 18. hous. action ill. & the lawyers’ comm. for better hous., prejudged: the stigma of eviction records 6 (2018), https://lcbh.org/sites/default/files/resources/prejudgedeviction-report-2018.pdf [https://perma.cc/w9sr-hhs6 ] (discussing cases dismissed after a settlement); see lillian leung et al., serial eviction filing: civil courts, property management, and the threat of displacement, 99 soc. forces 1 (2020) (discussing judgments entered after settlement). 19. serial cases also exemplify the fact that eviction, at least for some landlords, is a routine proceeding, in which the court acts as little more than a rubber stamp to compel a tenant to pay rent or get out. meanwhile, serial cases have tremendous ill effects for tenants. even if the tenant in a serial eviction case does not lose their home, they now have an eviction filing on their record – perhaps even a judgment as well – which will limit their ability to find high quality housing later. the tenant will likely be required to pay additional fees over and above the rent that was owed, like the landlord’s attorney fees, late fees, and the fee to file the case. leung et al., supra note 18, at 3. and, the tenant will have been forced to shoulder the psychological burden of being days away from losing their home. 20. states with relatively low serial filing rates include alabama, florida, washington, utah, west virginia, oklahoma, mississippi, kansas, indiana, and illinois. id. at 11. 2021] residential eviction and public housing 249 confronted with court-ordered eviction and even more with forced moves that do not directly involve the civil court system.21 eviction, even setting aside all other types of forced moves from rental properties, is common. to understand the health problems and potential solutions to the eviction crisis, both during the pandemic and following it, one must understand both the typical procedure of an eviction case and some key characteristics of a typical eviction case. the first characteristic is that eviction is common, as discussed above. eviction is also quick. this is a fast-moving legal process, despite its severe consequences in the lives of tenants, and it creates lasting trauma. the second characteristic will be addressed in the following discussion of how an eviction case typically moves through the court system. the third characteristic will be addressed in the next subsection, which is on the health impacts of eviction. each state outlines procedures for eviction cases – whether calling the process eviction, summary process, unlawful detainer, forcible entry and detainer, or another name in its civil code.22 depending on the state, further variation may exist between counties, cities, or other judicial boundaries, or procedures may be relatively consistent across the state. what follows is a general outline for a nonpayment of rent case that is not specific to any individual state. 1. notice to quit across most of the united states, an eviction case begins with the landlord issuing a “notice to quit” or “notice to vacate” to the tenant. the state’s civil code will usually provide specific requirements about the format of this notice (e.g., must be in writing, must be in language of the lease), as well as how many days must pass between the landlord issuing the notice and the landlord filing an eviction case in court. the notice to quit can take many forms. for example, a notice to quit might look like a text message from the landlord reading, “i didn’t get this month’s rent. you have three days to get me $890 plus a $45 late fee or i’m filing to evict,” or it can look like an official document printed on brightlycolored paper taped to the door that gives a fourteen-day window before the eviction case is filed. some tenants will leave after receiving this notice to quit and before an eviction case is filed. this choice may be the result of confusion – interpreting the notice, which might give two clear options of (1) pay rent or (2) leave, as a legal order to vacate rather than a warning notice in advance of a court case, during which the tenant would have an opportunity to mount a defense. on the other hand, leaving can also be a tenant’s informed decision based on the knowledge 21. see matthew desmond et al., forced relocation and residential instability among urban renters, 89 soc. forces 227, 244 (2015) (describing how informal eviction is twice as frequent as formal eviction). 22. arkansas also has criminal eviction procedures. see ark. code ann. § 18-16-101 (2021). 250 indiana health law review [vol. 18:243 that winning their case is unlikely.23 by vacating the apartment, they can evade a mark on their credit and rental history records that could become a cause for landlords to reject their rental applications for years to come (indeed, even if the tenant were to win their case).24 2. eviction filing assuming the tenant neither vacates nor pays the remaining rent, the landlord next files an eviction case in the appropriate court (e.g., county, district, municipal, housing) the case type may have a clear label like “eviction,” or it might be something more opaque to the general public, like “unlawful detainer” or “summary process.” depending on where the case is filed, this action might come with a steep filing fee or additional costs like attorney fees. in some areas, a property manager can represent the landlord, but in others, only either the owner of the unit or the owner’s attorney may appear. in maryland, filing fees range from $15 to $25,25 whereas in mobile, alabama, it costs $256 to file an eviction case.26 filing the case might be simple to do online, or it might require appearing in person, a relative inconvenience. 3. eviction hearing we do not know how many eviction cases nationwide end with a default judgment to the plaintiff, or, in plain terms, the landlord “winning” the eviction case because the tenant does not appear in court. based on the proportion of default judgments in places in the united states where the data is available, one can assume this number must be in the hundreds of thousands.27 when they do appear in court, tenants most often do not receive legal counsel, while landlords typically are represented by lawyers. as a rule of thumb, one can expect nine out of ten landlords to be represented, but only one in ten tenants.28 tenants are more 23. see karen tokarz et al., addressing the eviction crisis and housing instability through mediation, 63 wash. u. j.l. pol’y 243, 256-57 (2020) (discussing tenants’ low rates of success in st. louis, missouri.). 24. see gold, supra note 4; see also polk, supra note 4. 25. district court of maryland cost schedule, md. cts. (dec. 2020), https://www.courts. state.md.us/sites/default/files/court-forms/dca109.pdf [https://perma.cc/32b6-wmzt]. 26. leung et al., supra note 18, at 20. 27. see, e.g., reinvestment fund, resolving landlord-tenant disputes: an analysis of judgments by agreement in philadelphia’s eviction process 2 (2020), https://www.reinvestment.com/wp-content/uploads/2020/05/reinvestmentfund_report-2020_phlevictions-judgments-by-agreement-landlord-court.pdf [https://perma.cc/pe6k-6l4h]; the state of evictions, supra note 8. 28. e.g., hous. action ill. & the lawyers’ comm. for better hous., supra note 18; tokarz et al., supra note 23; evictions in the courts: an analysis of 106,000 cases from 2006-2016 in jackson county, kan. city eviction project (jan. 24, 2018), https://static1.squarespace. com/static/59ba0bd359cc68f015b7ff8a/t/5a68e811e4966bee3fb5d6cd/1516824594549/kc+evi 2021] residential eviction and public housing 251 likely to win eviction cases when represented, even when representation does not depend on the perceived merits of the case.29 eviction cases can end with a judgment for the plaintiff (i.e., landlord), judgment for the defendant (i.e., tenant), dismissal, or settlement (otherwise known as a stipulated settlement or simply a “stip”).30 common settlement stipulations include “pay and stay” or “pay and go” terms, which should avoid a judgment for the plaintiff – though still requiring the tenant to pay the past due rent and, in the latter case, move. notably, court fees and landlord attorney fees are often shifted to tenants who lose eviction cases or agree to pay and stay stipulations, significantly increasing the tenants’ housing costs.31 4. writ of possession issued following a judgment for the landlord, a writ of possession (sometimes alternatively called a writ of detainer or writ of eviction) is issued to the law enforcement agency tasked with enforcing court-ordered evictions. 5. writ of possession executed in the final stage of the eviction case, local law enforcement executes the writ of possession. this is what television news shows as “an eviction.” a sheriff and someone from a moving company arrive at the tenant’s door, open the apartment, and remove all of the tenant’s belongings into a truck (where the belongings will be held in storage at the tenant’s expense) or onto the curb. sometimes the tenant has already left by this stage, and the state-paid moving service might remove any belongings left behind in the haste to depart. from the first notice to the execution of the writ, the eviction process typically takes about a month,32 making it a quick legal process that belies the seriousness of the consequences of a case outcome in the plaintiff’s favor. for the landlord, this timeline can mean losing out on one month’s rent, any rent that was ction+project+-+courts+analysis.pdf [https://perma.cc/vj7e-5yt3]. 29. see d. james greiner et al., the limits of unbundled legal assistance: a randomized study in a massachusetts district court and prospects for the future, 126 harv. l. rev. 901 (2013); carroll seron et al., the impact of legal counsel on outcomes for poor tenants in new york city’s housing court: results of a randomized experiment, 35 l. & soc’y rev. 419 (2001); oksana mironova, nyc right to counsel: first year results and potential for expansion, community serv. soc’y (mar. 25, 2019), https://www.cssny.org/news/entry/nyc-right-to-counsel [https://perma.cc/u4cm-r62b]. 30. n. r. kleinfield, where brooklyn tenants plead the case for keeping their homes, n.y. times (may 20, 2018), https://www.nytimes.com/interactive/2018/05/20/nyregion/landlord-tenantdisputes-housing-court.html [https://perma.cc/g3hp-67ca]. 31. leung et al., supra note 18, at 3-4. 32. see, e.g., matthew desmond & tracy shollenberger, forced displacement from rental housing: prevalence and neighborhood consequences, 52 demography 1751, 1755 (2015); polk, supra note 4. 252 indiana health law review [vol. 18:243 owed at the beginning of the case,33 rent for the period of time it takes to find a new occupant for the unit, and any costs of the court proceeding that are not passed to the tenant. for a typical tenant, however, this means going from housed to not having a home in the span of two paychecks – hardly enough time to scrape together move-in costs (e.g., first and last month’s rent and a security deposit, often equal to another month’s rent) in a country where more than half of renters pay more than 30% of their income to rent and utilities every month34 and nearly half of renters have less than $1000 in savings.35 that is to say that an eviction case can easily cause a family’s living situation to change from housed to homeless – doubled up with friends or family, living in an unaffordable hotel or motel, checking into a shelter if beds are available, or sleeping in a car or on a sidewalk – in less than a month. b. effect of eviction on individual and public health what effect does eviction have on the health of individuals and families in normal, pre-pandemic times? research indicates that eviction should be regarded as a traumatic experience, given its links to poorer mental health outcomes, including increased likelihood of dying by suicide,36 higher rates of depression among mothers,37 and more.38 another thread in the literature of health and eviction considers housing quality and ties into the housing vein of the social determinants of health research. when tenants are evicted, or even merely filed against, that interaction 33. eviction lab data on judgment amounts – the amount of money that the court orders the tenant to pay to the landlord at the end of the suit, which can include attorney fees, late rent fees, damages, and court fees on top of missed rent – indicates that amounts of rent owed are typically quite low. in a sample of thousands of records across twenty-two states, about one-third of all judgment amounts were for less than the median amount for one month’s rent in that area. emily badger, eviction crises that a few hundred dollars could solve, n.y. times (dec. 18, 2019), https://www.nytimes.com/2019/12/12/upshot/eviction-prevention-solutions-government.html [https://perma.cc/v5ql-wcxe]. 34. press release, u.s. dep’t of hous. & urban dev., hud and census bureau release new american housing survey (sept. 16, 2020), https://www.hud.gov/press/press_releases_media_ advisories/hud_no_20_147 [https://perma.cc/cj5x-3azr]. 35. riordan frost, cash-strapped during covid-19, joint ctr. for housing stud. harv. u. (june 11, 2020), https://www.jchs.harvard.edu/blog/cash-strapped-during-covid-19 [https:// perma.cc/3lbx-lcnm] (analyzing of pre-pandemic data). 36. see katherine a. fowler et al., increase in suicides associated with home eviction and foreclosure during the us housing crisis: findings from 16 national violent death reporting system states, 2005-2010, 105 am. j. pub. health 311 (2015); yerko rojas & sten-åke stenberg, evictions and suicide: a follow-up study of almost 22,000 swedish households in the wake of the global financial crisis, 70 j. epidemiology community health 409 (2016). 37. see matthew desmond & rachel tolbert kimbro, eviction’s fallout: housing, hardship, and health, 91 soc. forces 295 (2015). 38. see hugo vásquez-vera et al., the thread of home eviction and its effects on health through the equity lens: a systematic review, 175 soc. sci. & medicine 199 (2017). 2021] residential eviction and public housing 253 with the civil justice system becomes part of their rental history, locking them out of high-quality housing for years to come.39 many landlords who offer highquality housing rule out all tenants who have received eviction orders.40 this explains why tenants who are evicted land in neighborhoods with much higher levels of crime and poverty compared to tenants whose most recent move was voluntary.41 at the same time, abundant research has established that poor-quality housing can make you sick.42 for example, household mold can cause a variety of respiratory issues,43 and lead paint causes developmental harm to children.44 as a result, when evicted tenants are locked out of safe and decent housing, they can also be thought of as locked into the health risks associated with subpar housing. eviction both directly causes health challenges for tenants and indirectly places tenants in situations where they will be exposed to further environmental harms. these health challenges are persistent, haunting tenants for years following their eviction. eviction should not, though, be considered merely a risk factor for an individual’s health. first, because eviction affects racial groups in the united states disproportionately, it should be considered among the factors that make racism a threat to public health.45 second, because evicted people have persistent differences in the ability to access high-quality housing for years following an eviction,46 eviction creates a group of “evicted people” who are, as a population, exposed to specific health risks. third, a small but growing number of neighborhood-level studies find positive correlations between rates of eviction and rates of health-related outcomes in a given neighborhood.47 that is to say that 39. gold, supra note 4, at 63; polk, supra note 4. 40. kleysteuber, supra note 4; desmond, supra note 4. 41. desmond & shollenberger, supra note 32, at 1763. 42. see generally mary shaw, housing and public health, 25 ann. rev. pub. health 397 (2004); emily a. benfer & allyson e. gold, there’s no place like home: reshaping community interventions and policies to eliminate environmental hazards and improve population health for low-income and minority communities, 11 harv. l. & pol’y rev. online s1 (2017). 43. dennis hevesi, the turmoil over mold in buildings, n.y. times (mar. 23, 2003), https://www.nytimes.com/2003/03/23/realestate/the-turmoil-over-mold-in-buildings.html [https://perma.cc/h9qa-vk7d]. 44. see generally emily a. benfer, contaminated childhood: how the united states failed to prevent the chronic lead poisoning of low-income children and communities of color, 41 harv. envtl. l. rev. 493 (2017). 45. see generally new ama policy recognizes racism as a public health threat, ama (nov. 16, 2020), https://www.ama-assn.org/press-center/press-releases/new-ama-policy-recognizesracism-public-health-threat [https://perma.cc/a33p-36rw] (stating the position of the american medical association that racism is a threat to public health). 46. gold, supra note 4; kleysteuber, supra note 4; polk, supra note 4. 47. e.g., lindsey rose bullinger & kelley fong, evictions and neighborhood child maltreatment reports, 31 housing pol’y debate (forthcoming 2021); aayush khadka et al., in utero exposure to threat of evictions and preterm birth: evidence from the united states, 55 health serv. res. 823 (2020); corey hazekamp et al., eviction and pediatric health outcomes 254 indiana health law review [vol. 18:243 it is possible that your neighbor’s eviction might not only affect your neighbor’s health but also your own.48 on the other side of the coin, these studies indicate that lowering eviction rates could improve the overall health of residents in a neighborhood. further, this bifurcation of the rental housing market into “evicted people, subpar properties” and “never-evicted people, general rental market” does not affect solely the adults who are listed as defendants on the eviction suit but also the children in the household. indeed, the presence of children has been identified as a risk factor for eviction.49 in addition to the above harms that subpar housing can cause to children’s health, research links housing instability generally to the types of harm to children’s health that can alter the course of the children’s lives.50 eviction does not cause one move, but it often a series of at least two moves. first, the eviction causes a move into subpar housing. then, one or more moves attempting to leave housing of that condition, which makes research on general housing instability all the more relevant for discussions on eviction.51 eviction’s harms are not limited to the effects of moves on the child’s psyche; eviction and the threat of eviction during gestation are associated with negative birth and neonatal health outcomes.52 this research into the effect of eviction on children indicates that this state process creates intergenerational cascades of harm. in sum, eviction is a stressor itself associated with poor health; a barrier to safe, decent housing; a trauma that can reverberate through a child’s later years; and potentially a poison to a neighborhood. all of these factors demand that experts and policymakers consider eviction not merely as an issue of individual responsibility and risk, but as a public health concern appropriately addressed through system-wide government intervention. c. public health in a pandemic the research cited above could all be said for “normal times.” these times are decidedly abnormal. as of this writing at the end of november 2020, and in the united states alone, more than thirteen million people have been confirmed in chicago, 45 j. community health 891 (2020). 48. cf. mariana arcaya et al., effects of proximate foreclosed properties on individuals’ systolic blood pressure in massachusetts, 1987 to 2008, 129 circulation 2262 (2014). 49. see matthew desmond et al., evicting children, 92 soc. forces 303 (2013). 50. see generally t. jelleyman & n. spencer, residential mobility in childhood and health outcomes: a systematic review, 62 j. epidemiology & community health 584 (2008). 51. desmond et al., supra note 20. 52. see khadka et al., supra note 47; kathryn m. leifheit et al., severe housing insecurity during pregnancy: association with adverse birth and infant outcomes, 17 int’l j. envtl. res. & pub. health 8659 (2020); corey hazekamp et al., eviction and pediatric health outcomes in chicago, 45 j. community health 891 (2020); gracie himmelstein & matthew desmond, association of eviction with adverse birth outcomes among women in georgia, 2000 to 2016, jama pediatrics (mar. 1, 2021), https://jamanetwork.com/journals/jamapediatrics/fullarticle/ 2776776 [https://perma.cc/l5fs-fnef]. 2021] residential eviction and public housing 255 to have covid-19. more than 250,000 of those people have died.53 during this emergency, an acute health problem emerges: evicted people will be at greater risk of contracting covid-19 due to decreased or non-existent ability to socially distance, wash hands, and wear masks following the eviction. additionally, each individual who contracts covid-19 both has the potential to spread the disease to others and has the potential to require assistance from a strained medical system.54 this crisis is not theoretical. a recent study estimated that lifting eviction moratoria in the summer of 2020 translated to more than 400,000 excess cases of covid-19 and 10,700 excess deaths from the illness.55 this acute health crisis cannot be separated from the existing eviction crisis, particularly because it shares similar racial disparities due to systemic racism. ii. covid-19 and eviction policy responses next, i consider the eviction-related policy measures that have been implemented by governments at all levels – local, state, and federal – to keep individuals and families safe from covid-19, to keep families’ housing secure during a period of economic turmoil, and to decrease community spread of the virus. i consider three major groups of eviction-related public health measures: (1) social distancing in housing courts; (2) rental assistance and other financial supports; and (3) eviction moratoria. many of these measures are tracked on the covid-19 housing policy scorecard, an online tool from the eviction lab and professor emily a. benfer that reports on the current status of statewide emergency housing policy in all fifty states and the district of columbia.56 when surveying judicial, legislative, and executive orders on eviction in the pandemic, one notices right away that the rationales listed by different policymaking bodies for these actions differ from one another. in other words, these officials do not all share the same single problem statement or goal. this could make evaluating the effectiveness of these policies using the same standard less appropriate. the supreme court of south carolina, for example, cited in their order that the covid-19 pandemic would create “difficulties” for “ institutions and individuals” and that “increased housing insecurity and homelessness [would] worsen the threat posed by the illness.”57 this order does not define the problem as eviction itself. instead, it defines the problem as forced 53. covid-19 united states cases by county, johns hopkins u. & med., https:// coronavirus.jhu.edu/us-map [https://perma.cc/w673-f59s ] (last visited dec. 3, 2020). 54. see eviction, health inequity, and the spread of covid-19, supra note 1; see also justin sheen et al., the effect of eviction moratoria on the transmission of sars-cov-2, at 1 (jan. 19, 2021) (unpublished manuscript) (on file with the indiana health law review). 55. leifheit et al., supra note 1, at 5. 56. covid-19 housing policy scorecard, eviction lab, www.evictionlab.org/covid-policyscorecard/ [https://perma.cc/szq8-6afh] (last visited mar. 15, 2021). 57. s.c., statewide evictions and foreclosures, 2020-03-18-01 (mar. 18, 2020), h t tps:/ /www.sccourts.org/courtorders/displayorder.cfm?orderno=2020-03-18-01 [https://perma.cc/6uza-tm66]. 256 indiana health law review [vol. 18:243 moves and one particular outcome of forced moves (i.e., homelessness).58 it also specifies that the problem with housing instability in this instance is that it will exacerbate the spread of covid-19.59 to curtail the threat of covid-19, the supreme court of south carolina paused all eviction enforcement actions and its ability to accept eviction filings, schedule hearings, or issue writs.60 the court’s order included a similar set of restrictions for foreclosure cases.61 the rationale presented by the court characterizes the order as both an act of mercy toward individuals in an extreme time and a necessary threat-reducing public safety measure.62 this second rationale, that eviction is tied to the public health response, is articulated even more clearly in some other orders. for example, a march directive for implementing executive orders states plainly that “[e]victing montanans from their homes during the emergency will only worsen the [s]tate’s ability to respond to the emergency.”63 in another example, an executive order in indiana that contained an eviction moratorium articulated a slightly different rationale. the indiana order sought “to avoid the serious health, welfare, and safety consequences that may result if hoosiers are evicted or removed from their homes . . . .”64 the order did not explicitly specify the population that would experience these serious health, welfare, and safety consequences (e.g., all hoosiers and residents of neighboring states).65 however, in the absence of another population, one can assume that it is the hoosiers who are evicted or otherwise removed from their homes who would suffer these deleterious consequences. as such, the order articulates a rationale that, in this emergency, the state should intervene to protect individuals who might be exposed to risks to their health, welfare, and safety by being evicted. unlike south carolina’s approach, indiana does not clearly reference a risk to the public, which is inherent in residents losing access to housing.66 also, the indiana order does not explicitly tie housing to the public health struggle against the covid-19 pandemic.67 although south carolina mentioned “difficulties” 58. see id. 59. id. 60. id. 61. id. 62. see id. (“in recognition of the difficulties the covid-19 pandemic may have on institutions and individuals . . . .”). 63. mont. exec. order nos. 2-2020 & 3-2020 (apr. 13, 2020), https://dphhs.mt.gov/portals/ 85/documents/coronavirus/lowincomerentassistancedirective.pdf [https://perma.cc/a3knjymr]. 64. ind. exec. order no. 20-06 (mar. 19, 2020), https://www.in.gov/gov/files/eo_20-06.pdf [https://perma.cc/28xr-cb7j]. 65. see id. 66. see id. 67. see id. 2021] residential eviction and public housing 257 that could include financial strain,68 neither order made the argument that preventing a given household’s eviction during the pandemic, which is a time of extreme financial stress, shields that household from long-term harm. both the south carolina and indiana orders were issued early in the pandemic – in the middle of march – and applied to all renters and eviction cases. the orders differ slightly in how they frame the problem and its solution, but the main solution is the same: prevent anyone from being evicted because anyone being evicted would cause serious negative consequences. as the pandemic wore on, new orders more often limited protection to tenants who could demonstrate financial difficulties due to covid-19. this approach implies a different principle. instead of it being imperative to reduce all evictions to as near zero as possible, allowing tenants only to be removed if the safety or life of another person is at risk, the principle is that covid-19 should not be a reason why anyone is evicted. this principle implies concern about what economists call a “moral hazard.”69 specifically, the concern that if the punishment for not paying rent or losing one’s home is removed, people will simply stop paying rent. this splits tenants facing eviction into two groups: those deserving and undeserving of protection. this approach to emergency housing policy has a number of flaws. first, the moral hazard argument deteriorates when considering that the money will come due eventually and the debt could well be unaffordable. renters are aware of this fact, that the moratorium does not make rent a “free lunch.” even as eviction moratoria blanketed much of the united states and unemployment claims skyrocketed,70 more than one in ten renters told census surveyors that they were “not at all confident” that next month’s rent would be paid on time.71 also, industry groups reported that the vast majority of renters stayed up-to-date on rent.72 second, programs or policies that apply only to certain tenants require those tenants either to prove or to self-certify that they qualify. in the former case, this 68. s.c., statewide evictions and foreclosures, 2020-03-18-01 (mar. 18, 2020), https://www.sccourts.org/courtorders/displayorder.cfm?orderno=2020-03-18-01 [https://perma.cc/6uza-tm66]. 69. see definition of ‘moral hazard,’ econ. times, https://economictimes.indiatimes.com/ definition/moral-hazard [https://perma.cc/qeh3-422v] (last visited mar. 24, 2021). 70. see about 30 million workers are collecting jobless benefits, n.y. times, https://www.nytimes.com/live/2020/07/23/business/stock-market-today-coronavirus#roughly-onein-five-workers-are-collecting-unemployment-benefits [https://perma.cc/95q3-hupx] (last updated july 24, 2020). 71. the census phase 2 household pulse survey and rental housing during the pandemic, pd&r edge, https://www.huduser.gov/portal/pdredge/pdr-edge-frm-asst-sec-092820.html [https:// perma.cc/3jpf-pqld] (last visited dec. 4, 2020) (showing data for early september 2020). 72. press release, nat’l multifamily hous. council, nmhc rent payment tracker finds 90.6 percent of apartment households paid rent as of october 20 (oct. 22, 2020), https://www.nmhc.org/news/press-release/2020/nmhc-rent-payment-tracker-finds-90-6-percent-ofapartment-households-paid-rent-as-of-october-20/ [https://perma.cc/ku35-3bdm]. 258 indiana health law review [vol. 18:243 often requires documentation that tenants may not have, such as proof of loss of income or documentation proving that the tenant applied for every available rental assistance program.73 this means that there would be tenants who fulfill the qualifications for the program or policy, but who are not able to prove that they fulfill the qualifications. thus, they would be locked out of receiving assistance. third, many of these programs and policies require affirmative action on the part of the tenant in order to claim the right or receive assistance. for example, an early eviction moratorium in california required tenants to inform their landlords of their covid-19-related financial distress within seven days of missing rent in order to receive protection from eviction,74 and the cdc eviction moratorium requires tenants to fill out a form and deliver it to their landlords.75 this, again, has the result that many tenants who are intended to be covered by the order are not covered. not all qualifying tenants will be aware of the new emergency measure. when discussing the relative strengths or weaknesses of the emergency programs and policies below, i start with a premise that every person in the united states should be housed. no person should be without shelter during this pandemic. this is not only a moral stance but also one rooted in the public health reality that every family that is evicted during the pandemic is at increased risk for contracting covid-19, a risk that not only affects them but also affects their neighbors and community. this risk to the community is the result of both the chance that an evicted person with covid-19 could pass the virus to others and because limited medical resources (e.g., ventilators, icu beds, and medical staff) have caused leading medical and public health experts to worry that the united states’ medical system will reach capacity, forcing rationing of care.76 with this in mind, this section generally considers a few types of policies and programs that were implemented during the pandemic and whether they worked. the section then considers a few example emergency policy regimes in different parts of the united states. a. social distancing measures in courts in mid-march, as the united states became aware of unchecked community 73. see, e.g., bryce covert, despite the cdc’s eviction ban, thousands of tenants are losing their homes, nation (nov. 24, 2020), https://www.thenation.com/article/society/evictionstenants-covid/ (stating that some courts are holding evidentiary hearings to examine tenants’ declarations regarding lost work and efforts made in purportedly seeking rental assistance). 74. cal. exec. order no. n-37-20 (mar. 27, 2020), https://www.gov.ca.gov/wp-content/ uploads/2020/03/3.27.20-eo-n-37-20.pdf [https://perma.cc/a9nu-ze5d]. 75. temporary halt in residential evictions to prevent the further spread of covid-19, 85 fed. reg. 55,292 (sept. 4, 2020). 76. reed abelson, covid overload: u.s. hospitals are running out of beds for patients, n.y. times (nov. 27, 2020), https://www.nytimes.com/2020/11/27/health/covid-hospitalsoverload.html [https://perma.cc/r3tk-a3z9]; e.g., an open letter to the people of wisconsin, u. wis. health, https://coronavirus.uwhealth.org/an-open-letter-to-the-people-of-wisconsin/ [https:// perma.cc/h4n2-km88] (last visited mar. 15, 2021). 2021] residential eviction and public housing 259 spread of the novel coronavirus that causes covid-19, courts and other public buildings began to shut their doors. many courts across the country implemented emergency closures in the spring, but nearly all courts “reopened” to allow eviction proceedings by the end of 2020, whether in person or by video or phone conferencing.77 video conference proceedings might appear to widen access to justice relative to in-person court by removing the barrier of getting to the courthouse, but, in fact, many tenants lack access to the technology required for video conferences.78 plus, even when the video link technology works smoothly on both ends, research indicates that video conference hearings might result in worse outcomes for tenants compared to in-person hearings.79 video conference proceedings are used to reduce the likelihood of a tenant, judge, court staff person, or advocate being exposed to covid-19 at the courthouse or during the proceeding, though there remains the chance of exposure if any of these parties must be in a public place to take the video call (e.g., a judge who dials in from a courtroom or a tenant who joins a call from a place with public wi-fi). at least one court relocated to a convention center to support social distancing between people before, during, and after eviction proceedings.80 these measures reduce the risk of transmission of covid-19 during the pandemic, but they do not respond to the public health risk inherent in removing people from their homes. while courts should avoid gathering large numbers of people in the courthouse, attending to the congregation problem without acknowledging the public health risk inherent in allowing eviction cases to proceed fails to see the forest for the trees. 77. see judiciary preparedness for coronavirus (covid-19), u.s. cts. (mar. 12, 2020), https://www.uscourts.gov/news/2020/03/12/judiciary-preparedness-coronavirus-covid-19 [https://perma.cc/a83k-c2k2]. 78. e.g., chris arnold, zoom call eviction hearings: ‘they’ll throw everything i have out on the street,’ npr (june 19, 2020), https://www.npr.org/2020/06/19/880859109/zoom-calleviction-hearings-they-ll-throw-everything-i-have-out-on-the-street [https://perma.cc/33bg-8y3c]; cf. mark lieberman, laptop delays, zoom glitches, equity gaps: remote learning faces big challenges, educ. wk. (aug. 24, 2020), https://www.edweek.org/leadership/laptop-delays-zoomglitches-equity-gaps-remote-learning-faces-big-challenges/2020/08 [https://perma.cc/6z57-6chz]. 79. lorelei laird, videoconferencing’s promise of increased access to justice has a disconnect in immigration courts, a.b.a.j. (july 1, 2019), https://www.abajournal.com/magazine/ article/videoconferencings-access-to-justicei-immigration-courts [https://perma.cc/nhy2-au6f] (discussing videoconferencing in immigration court); christina goldbaum, videoconferencing in immigration court: high tech solution or rights violation?, n.y. times (feb. 12, 2019), https://www.nytimes.com/2019/02/12/nyregion/immigration-court-video-teleconferencing.html [https://perma.cc/w9pl-u5v9]; cf. aaron hass, videoconferencing in immigration proceedings, 5 pierce l. rev 59 (2006). 80. kriston capps, the columbus convention center is now a pandemic housing court, bloomberg citylab (june 18, 2020), https://www.bloomberg.com/news/articles/2020-0618/how-do-you-hold-housing-court-in-a-pandemic [https://perma.cc/nez3-phpy]. 260 indiana health law review [vol. 18:243 b. financial assistance financial assistance plays a key role in preventing evictions during the covid-19 pandemic. one problem with eviction moratoria is that tenants who miss rent during the covered period may well still have rental debt at the end of the moratorium, even if they become financially stable enough to pay rent moving forward. for example, consider a service worker who is laid off in april and misses rent in may and june while she waits to begin receiving unemployment. she is not able to pay those two months of rental debt, even when she receives benefits or resumes working later in the summer. when one in four of american households who rent pays more than half of the household’s income to rent and utilities each month,81 coming up with an additional month or two of rent over the course of a short period of time is not possible for many. tenants with outstanding rental debt following the expiration of the eviction moratorium then face eviction or civil debt collection proceedings. financial assistance is necessary for tenants to come out on the other side of the moratorium without these insurmountable debts. the expanded unemployment insurance payments funded through the cares act are one example of financial assistance offered during the pandemic. the extra $600 per week kept the rent paid for millions of out-of-work tenants.82 the federal government also issued a one-time $1,200 stimulus check to every american.83 more commonly, though, financial assistance comes in the form of rental assistance paid directly to landlords. the national low income housing coalition (“nlihc”) is tracking rental assistance programs during the pandemic. as of october 2020, it had identified 438 rental assistance programs totaling nearly $4 billion in funding.84 four major problems have become apparent with respect to rental assistance. first, the programs are woefully underfunded.85 four 81. joint ctr. for hous. studies, harvard u., america’s rental housing 2020, at 4 (2020), https://www.jchs.harvard.edu/sites/default/files/reports/files/harvard_jchs_americas_ rental_housing_2020.pdf [https://perma.cc/dg6k-kmx2]. 82. mary k. cunningham et al., don’t overlook the importance of unemployment benefits for renters, urb. inst. (apr. 23, 2020), https://www.urban.org/urban-wire/dont-overlookimportance-unemployment-benefits-renters [https://perma.cc/4mmb-vy85]. 83. kenneth terrell, stimulus checks: who is eligible and how much will they be?, aarp (mar. 11, 2021), https://www.aarp.org/politics-society/advocacy/info-2020/coronavirus-stimuluschecks.html [https://perma.cc/z5he-9qlv]. 84. rebecca yae et al., nlihc research note: emergency rental assistance programs in response to covid-19 3 (2020), https://nlihc.org/sites/default/files/emergencyrental-assistance-programs-3.pdf [https://perma.cc/5e4s-nbua]. 85. e.g., elizabeth trovall, $15 million in rent relief claimed in less than 2 hours, as tenant demand creates lag in response, hous. pub. media (may 15, 2020), https://www. houstonpublicmedia.org/articles/news/houston/2020/05/13/369448/houstons-15-million-rent-relieffund-drained-in-under-two-hours [https://perma.cc/525z-a8qp]; leon fooksman, applications for housing assistance in coral springs closed minutes after opening monday, tap into coral springs (aug. 24, 2020), https://www.tapinto.net/towns/coral-springs/sections/government/ articles/applications-for-housing-assistance-in-coral-springs-closed-minutes-after-opening-monday 2021] residential eviction and public housing 261 billion dollars in funding pales in comparison to the $100 billion that nlihc estimates would be required to keep tenants housed through this crisis.86 second, narrow eligibility requirements and strenuous application processes make it more difficult for tenants in need to access financial assistance.87 these eligibility requirements sometimes include the requirement that the landlord already has filed to evict before the tenant can apply for assistance, a stipulation that requires tenants be branded with the “scarlet e” to access help even if the landlord would prefer not to involve the courts.88 third, not all programs cover both rental arrears (i.e., unpaid, past-due rent) and future rent payments, nor do programs cover enough months of each. only 4% of the programs tracked by nlihc extended further than six months,89 even as unemployment remains stubbornly high, other benefits (e.g., extended unemployment insurance) that could pay rent expire, and schools and other childcare facilities remain closed in many parts of the country.90 the fourth problem with rental assistance programs concerns landlord behavior. there have been reports of landlords not agreeing to participate in rental assistance programs, sometimes because participation in the program (i.e., accepting the taxpayer money) comes with restrictions like not filing to evict the tenant for a certain number of days.91 on the other end, at least one landlord was found to have evicted his tenant even after a rental assistance program paid the tenant’s rental arrears.92 the scale of these problems is not known. still, given the enormous impact that eviction can have in a tenant’s life, these concerns about landlord behavior may be a sufficient reason to investigate cash assistance – programs like the one-time stimulus payment and expanded unemployment insurance – as an alternative to rental assistance programs. c. eviction moratoria: many opportunities for intervention different actors control various parts of the eviction process, which allow states, cities, and the federal government many points of entry to introduce [https://perma.cc/j2hh-3u4l]. 86. andrew aurand et al., nlihc research note: the need for emergency rental assistance during the covid-19 and economic crisis 2 (2020), https://nlihc.org/sites/ default/files/need-for-rental-assistance-during-the-covid-19-and-economic-crisis.pdf [https://perma.cc/q6uw-gfvs]. 87. yae et al., supra note 84, at 5-6; rental relief programs in major cities and counties in texas: what we learned from nine local governments across the state, texas housers 6-7 (july 27, 2020), https://texashousers.org/wp-content/uploads/2020/07/rental-reliefrecommendations-v4.0-wo-es.pdf [https://perma.cc/mj4p-wk4g]. 88. yae et al., supra note 84, at 6. 89. id. at 8. 90. as of writing in november 2020. 91. see generally id. (discussing the program requirements, including an agreement by landlords to drop eviction cases and late fees in exchange for assistance). 92. matthew desmond, the rent eats first, even during a pandemic, n.y. times (aug. 29, 2020), https://www.nytimes.com/2020/08/29/opinion/sunday/coronavirus-evictions-superspreader. html [https://perma.cc/9gx6-94yk]. 262 indiana health law review [vol. 18:243 interventions that interrupt evictions during the crisis. among other housingrelated actions, during the covid-19 pandemic, governors suspended the statutes giving causes of action for non-emergency eviction cases,93 banned eviction filings,94 and forbade the execution of eviction orders.95 state court systems continued all eviction cases,96 stopped taking new eviction filings,97 ordered eviction hearings not to be scheduled or heard,98 and stayed eviction judgments and writs.99 at least one major public safety department announced that they would not serve writs of possession.100 legislatures made it illegal to evict someone for nonpayment of rent during the emergency.101 forty-three out of fifty states, plus the district of columbia, implemented some form of evictionprevention measures other than or in addition to economic supports.102 to discuss the diversity in eviction moratoria in this subsection and the following, i use the framework from the covid-19 housing policy scorecard (the “scorecard”).103 the scorecard categorizes interventions into five categories.104 the first three roughly correspond to the five chronological stages of the eviction process listed above: (1) initiation covers the notice and filing of the order; (2) court process covers hearings and whether eviction judgments or 93. see a survey on restrictions on eviction and foreclosure remedies, king & spaulding, https://www.kslaw.com/pages/a-survey-of-restrictions-on-eviction-and-foreclosure-remedies [https://perma.cc/tq3w-xjf2] (last visited mar. 28, 2021). 94. e.g., minn. exec. order no. 20-79 (july 14, 2020), https://mn.gov/governor/assets/ eo%2020-79%20final%20signed%20and%20filed%20(002)_tcm1055-440501.pdf [https://perma.cc/ash6-ecxa]. 95. see a survey on restrictions on eviction and foreclosure remedies, supra note 93. 96. e.g., va., fifth order modifying and extending declaration of judicial emergency in response to covid-19 emergency (june 1, 2020), https://arlingtonva.s3.amazonaws.com/wpcontent/uploads/sites/9/2020/06/supreme-court-of-virginia-order-modifying-and-extendingdeclaration-of-judicial-emergency.pdf [https://perma.cc/q7fq-nwyw]. 97. see ann o’connell, emergency bans on evictions and other tenant protections related to coronavirus, nolo, https://www.nolo.com/evictions-ban [https://perma.cc/77cg-p3xf] (last updated mar. 23, 2021). 98. e.g., haw., in the matter of the judiciary’s response to the covid-19 outbreak, scmf20-0000152 (mar. 16, 2020), https://www.courts.state.hi.us/wp-content/uploads/2020/03/031619_ scmf-20-152_in_re_covid-19.pdf [https://perma.cc/g753-q24z]. 99. see a survey on restrictions on eviction and foreclosure remedies, supra note 93. 100. e.g., public safety sheriff division temporarily suspends eviction activities, haw. dep’t pub. safety (mar. 17, 2020), https://governor.hawaii.gov/newsroom/latest-news/psd-newsrelease-sheriff-division-temporarily-suspends-eviction-activities/ [https://perma.cc/cd6x-cukw]. 101. see a survey on restrictions on eviction and foreclosure remedies, supra note 93. 102. covid-19 eviction moratoria & housing policy, supra note 5. 103. emily a. benfer et al., covid-19 housing policy scorecard methodology, eviction lab (apr. 20, 2020), https://evictionlab.org/covid-housing-scorecard-methods/ (describing the eviction lab’s full methodology with scoring details) [https://perma.cc/6xhb-ua2x] [hereinafter covid-19 housing policy scorecard methodology]. 104. id. 2021] residential eviction and public housing 263 writs are stayed; and (3) enforcement covers whether law enforcement is permitted to physically carry out the eviction order. each also corresponds to a different actor: measures in the initiation category, once implemented, curtail actions taken by the landlord; court process corresponds to the courts; and enforcement corresponds to law enforcement officers. orders that integrate one or more measures from these three categories can be referred to as eviction moratoria because these orders contain direct blocks to the eviction process.105 the other two categories on the scorecard, short-term supports and tenancy preservation measures, track measures that support housing stability but do not constitute eviction moratoria (e.g., implementing a rental assistance program, sealing or masking eviction cases, or banning late fees – which can artificially raise rental arrears, making rental assistance programs more expensive for the state).106 three supportive measures on the scorecard are unscored: whether the state mandated landlords to file an affidavit certifying that the property was not “covered” under the cares act federal eviction moratorium when filing to evict and whether utility providers were banned from shutting off service due to nonpayment or required to restore service previously disconnected due to nonpayment.107 the first of these measures is not scored because it merely tracked whether the state was taking a step to follow federal law. the latter two are not scored due to jurisdictional differences between states that prevent state actors from creating these measures as a binding policy for all utilities. not all eviction moratoria produce equally effective results. though it will not be possible to craft a full reckoning of which policies were more effective and which were less effective until after the pandemic has concluded and more data have been collected, preliminary evidence strongly indicates that interventions that blocked earlier stages in the eviction process were more effective at reducing eviction filings than interventions that blocked later stages.108 in other words, late interventions like blocking enforcement of writs of eviction do not produce a complete chilling effect that discourages all eviction filings. blocking eviction notices and filings, rather than just enforcement of eviction orders, is key because tenants move out at all stages of the eviction process, beginning with the first notice to quit. still, across the country, initial data from the collection of court filings indicate that the eviction moratoria of all types worked and are working to reduce eviction filings.109 where eviction moratoria remain as of this writing, eviction filings are low, and where local eviction moratoria have been phased out, 105. id. three measures in these categories – specifically the measures requiring certification that a property was not subject to the cares act federal moratorium, tolling court deadlines, and sealing eviction records – do not constitute eviction moratoria. 106. see id. 107. see id. 108. see hepburn & louis, supra note 1; eviction filings during and after local eviction moratoria, supra note 1. 109. see id. 264 indiana health law review [vol. 18:243 eviction filings have immediately risen.110 generally speaking, eviction moratoria implemented near the beginning of the crisis were short-term but comprehensive (e.g., executive or judicial orders blocking all eviction filings or all hearings for thirty days). as the pandemic wore on, more eviction moratoria were introduced with restrictions (e.g., only protecting tenants that could demonstrate financial difficulties caused by the pandemic). in the summer, states began phasing out eviction moratoria at the same time that rental assistance programs began accepting applications. by the fall, most eviction moratoria still in place were long-term, like the new jersey moratorium that will remain in place until forty-five days after the expiration of the state of emergency, or extended monthly like clockwork, as is the case for orders in illinois and minnesota.111 at some point during the pandemic, all but seven states implemented a statewide eviction moratorium of some kind.112 only fourteen states and the district of columbia still have eviction moratoria in place as of november 30, 2020.113 d. weak points in pandemic housing responses as discussed above, emergency housing policy orders were, and still are, riddled with holes that compromise their effectiveness at reducing the number of forced moves due to evictions that occur during the pandemic. this subsection briefly summarizes four common flaws that have prevented housing stability orders from keeping as many people housed as possible. in addition to these flaws, the timing of an order also affects the order’s success. orders that began well after the pandemic or ended before the economic crisis ended and aid was distributed (a point in time that has not been reached by this writing) necessarily cannot be as successful as orders that cover more of the crisis time period. 1. intervention targets action too late in the process some eviction moratoria only block the enforcement of an eviction order. this creates several problems. first, tenants move out at all points in the eviction process, so allowing nearly the entire eviction process to run out introduces the risk that tenants will move after receiving the notice to quit, the filing, or immediately following the hearing. this defeats the purpose of the order in keeping people from moving, doubling-up with other families, or becoming homeless, all of which introduce potential for the tenant to contract covid-19 and expose others to the illness. this downside could be prevented if such a moratorium created a “chilling effect” so pervasive that landlords opted not to file at all. however, data on eviction filings shows that the chilling effect was not this pervasive. for example, in florida, the governor signed a series of executive 110. leifheit et al., supra note 1; see hepburn & louis, supra note 1; see eviction filings during and after local eviction moratoria, supra note 1. 111. covid-19 eviction moratoria & housing policy, supra note 5. 112. id. 113. covid-19 housing policy scorecard, supra note 56. 2021] residential eviction and public housing 265 orders that included eviction moratoria.114 the last of these orders, in place for the months of august and september, were enforcement-only eviction moratoria that postponed only enforcement of eviction orders and only for households that had experienced financial hardship due to the pandemic.115 during the last month of the order, september 2020, more than 900 eviction cases were filed in duval county, florida, home to florida’s capital, jacksonville.116 two other problems emerge because of this flaw. if the intervention targets an action after the initial filing, tenants are not protected from the long-term harm of an eviction filing blocking access to safe and healthy housing. additionally, allowing the entire court process to play out limits tenants’ ability to secure rental assistance that could prevent the eviction. 2. intervention only apply to subsets of renters or types of housing other programs and policies fail because they do not apply universally to all tenants. for example, the city of boston announced to great fanfare an “eviction moratorium,” which was in place through the end of 2020 and applied only to public housing.117 this measure, which protects some of our most economically vulnerable neighbors from eviction, is important, but one must remember that for every low-income renter who receives housing assistance, there are three others who do not.118 boston’s so-called “eviction moratorium” leaves renters in the far larger private, unassisted rental market without protection. flaws in policies narrowly targeting tenants who have experienced financial hardship due to the pandemic are discussed above. 3. intervention requires action by the tenant this problem often accompanies interventions that only apply to subsets of renters or types of housing. if tenants must take an action to receive a right or benefit, there will be tenants who do not take the action because they are not 114. fla. exec. order no. 20-180 (july 29, 2020), https://www.flgov.com/wp-content/uploads/ orders/2020/eo_20-180.pdf [https://perma.cc/b5hg-8ym3]; fla. exec. order no. 20-211 (aug. 31, 2020), http://www.flchamber.com/wp-content/uploads/2020/09/eo-20-211.pdf [https://perma .cc/qb63-pgpc]. 115. fla. exec. order no. 20-211. 116. eviction tracking system, eviction lab (dec. 12, 2020), https://evictionlab.org/ eviction-tracking/ [https://perma.cc/3sv9-zr67]. 117. press release, mayor martin j. walsh & the bos. hous. auth., mayor walsh, boston housing authority extend moratorium for nonessential evictions through 2020 (july 10, 2020), https://www.bostonhousing.org/en/news/mayor-walsh,-boston-housing-authority-extendmorat.aspx [https://perma.cc/2nfu-l7uw]. 118. three out of four low-income at-risk renters do not receive federal rental assistance, ctr. on budget & pol’y priorities (aug. 2017), https://www.cbpp.org/three-out-offour-low-income-at-risk-renters-do-not-receive-federal-rental-assistance [https://perma.cc/4jcb6yct]. 266 indiana health law review [vol. 18:243 aware of the order. a state or city could attempt to bridge this information gap by implementing a costly and difficult outreach and education campaign. indeed, governments at all levels should take tenant education seriously, even if tenant action is not needed to receive the protection. during the covid-19 emergency, however, when time is of the essence, it is contrary to the public good to wait for a tenant to learn about what might be a quite complex new law, evaluate if they qualify for the protection or program, gather any documentation, apply or otherwise submit documentation, and wait for the application to be evaluated, or for an evidentiary hearing to take place. this is not to mention that if a tenant must take an action to inform the landlord that they will invoke their right not to be evicted or to apply for rental assistance, the state runs the risk of bad action by the landlord. for example, at one point, california’s eviction moratorium required tenants to have experienced financial distress due to covid-19 and to report this to their landlords.119 a landlord could, though, file to evict and take their chances for whether the landlord would appear in court to claim that the filing was unlawful – either out of ignorance of the law or willfully breaking the law. this is, in essence, a moral hazard argument, alleging that the tenant will break the law. however, unlike this tenant moral hazard argument, for which little evidence has surfaced during the pandemic, news organizations have identified hundreds of instances where landlords illegally filed evictions against tenants covered by the cares act.120 some types of programs always seem to require a request or application on the part of the tenant, like rental assistance. but if for the sake of argument, we assume as a premise that successful programs do not require tenants to jump through hoops, wait for applications to be evaluated, and the like, then another road emerges: cancel all rental debt121 (e.g., suspend the cause of action statues for nonpayment of rent eviction and pass a law that rental debt from the pandemic cannot be retrieved through the eviction or small claims court process) and create a landlord bailout fund to which landlords apply to recoup lost rent. such a program might even require the landlord to go to the tenant to certify that the landlord has fulfilled obligations related to the condition of the unit and that the landlord is requesting the appropriate amount of money based on the agreed-upon rent. 119. cal. exec. order no. n-37-20 (mar. 27, 2020), https://www.gov.ca.gov/wp-content/ uploads/2020/03/3.27.20-eo-n-37-20.pdf [https://perma.cc/a9nu-ze5d]. 120. e.g., jeff ernsthausen et al., despite federal ban, landlords are still moving to evict people during the pandemic, propublica (apr. 16, 2020), https://www.propublica.org/article/ despite-federal-ban-landlords-are-still-moving-to-evict-people-during-the-pandemic [https://perma.cc/9ayd-a3bc]. 121. see keeanga-yamahtta taylor, cancel the rent, new yorker (may 12, 2020), https://www.newyorker.com/news/our-columnists/cancel-the-rent [https://perma.cc/d2dn-xxbr]; see also h.r. 6515, 116th cong. § 2 (2020). 2021] residential eviction and public housing 267 4. intervention postpones the risk of eviction any eviction moratorium that is not accompanied by financial support postpones but does not eliminate the risk of eviction. successful interventions require both an eviction moratorium – a broad measure that eliminates the immediate risk of eviction without requiring intervention by the tenant – and financial support to assist the tenant in paying any debts. financial support without an eviction moratorium fails because the support can take a considerable amount of time to come through, which is a time during which a landlord may file for eviction. not all tenants at risk of eviction will successfully apply for assistance, and not all landlords will take the money, especially if they are able to remedy the rent loss by evicting the tenant. an eviction moratorium without financial support fails because the moratorium will one day end, and tenants who have accumulated rental debt may well be unable to pay the debt off. thus, they will face eviction. these policies, financial support and eviction moratorium, are two sides of the same coin. financial supports are discussed at greater length above. iii. example policies in this section, i consider a few different emergency anti-eviction policy regimes implemented at different levels of government. this small sample of policy responses does not represent the range of all responses available during the pandemic. this section instead illustrates what the above ideas looked like in practice in different states. this section also explores how a one-size-fits-all policy regime would not only fail in every state due to differences in governmental powers and politics but also is not necessary. states, local governments, and the federal government have many paths to the same goal of reducing evictions during the pandemic. a. massachusetts massachusetts implemented the strongest anti-eviction protections in the country according to the scorecard, scoring 4.15 out of 5 stars.122 the highscoring suite of measures was in place from april 20, 2020, to october 17, 2020. the road to the strongest policy in the country took more than a month following the first wave of stay-at-home orders. on march 13, 2020, the massachusetts housing court issued a standing order that continued all nonemergency cases until april 21, 2020.123 city governments in cambridge and somerville also issued orders preventing evictions from being enforced during the state of emergency, which prevented writs of eviction that had already been 122. covid-19 housing policy scorecard, supra note 56. 123. mass., temporary modifications to court operation arising from the coronavirus (covid 19) outbreak, standing order 2-20 (mar. 13, 2020), https://www.mass.gov/doc/housingcourt-standing-order-2-20-temporary-modifications-to-court-operations-arising-from-the/download [https://perma.cc/u63r-e9zp]. 268 indiana health law review [vol. 18:243 issued from being enforced.124 the massachusetts supreme court, that same month, ordered that only emergency cases that could not be heard remotely should be heard in person, and all others should be remote.125 in turn, the housing court updated their standing order and clarified that emergencies, in this instance, were situations like temporary restraining orders when a landlord illegally locks out a tenant or shuts off a tenant’s heat.126 at the beginning of april 2020, the housing court extended these measures to the beginning of may 2020.127 meanwhile, advocates in massachusetts lobbied for more protections, and the massachusetts legislature drafted stronger measures.128 a bill began circulating in the first two weeks of april 2020, and it rapidly passed both chambers and was signed into law by the governor, with an effective date of april 20, 2020.129 the new law would be in force for forty-five days following the expiration of the state of emergency, and it included a provision that permitted the governor to extend the law.130 at the time this law came into effect, my colleagues and i considered this to be a generously long timeline. 124. city of cambridge issues emergency temporary eviction enforcement order, city cambridge (apr. 3, 2020), https://www.cambridgema.gov/covid19/news/2020/04/eviction moratorium [https://perma.cc/9eg5-gxnt]; somerville issues eviction moratorium, orders unit showing to cease, somerville times (mar. 30, 2020), https://www.thesomervilletimes.com/ archives/98644 [https://perma.cc/6xug-f7jl]. 125. mass., order limiting in-person appearances in state courthouses to emergency matters that cannot be resolved through a videoconference or telephonic hearing, oe-144 (mar. 17, 2020), https://www.mass.gov/doc/repealed-sjc-order-limiting-in-person-appearances-instate-courthouses-to-emergency-matters/download [https://perma.cc/79kf-ckmd]. 126. mass., supplement to housing court standing order 2-20 relating to the coronavirus (covid-19) outbreak, standing order 3-20 (mar. 17, 2020), https://www.mass.gov/doc/housingcourt-standing-order-3-20-supplement-to-housing-court-standing-order-2-20-relating-to/download [https://perma.cc/6dwd-zbm2]. 127. mass., supplement to housing court standing order 2-20 and 3-20 relating to the coronavirus (covid-19) outbreak, standing order 4-20 (apr. 3, 2020), https://www.mass.gov/ doc/housing-court-standing-order-4-20-supplement-to-housing-court-standing-orders-2-20-and-320/download [https://perma.cc/3sws-ed4j]. 128. see erin tiernan, eviction filings off to slow start, court data reveal, bos. herald (nov. 2, 2020), https://www.bostonherald.com/2020/11/02/eviction-filings-off-to-slow-start-courtdata-reveal/ [https://perma.cc/bcd9-8aj6]. 129. mass. gen. laws ch. 65, § 3 (2020). 130. mass. gen. laws ch. 65, §§ 6, 7 (2020). 2021] residential eviction and public housing 269 table 1: statewide eviction-prevention measures effective in massachusetts on may 1, 2020131 initiation court process enforcement short term supports tenancy preservation u landlords cannot give notices to quit u landlords cannot file for eviction for any non-emergency reason u court deadlines are tolled for the duration of the act u courts cannot schedule or hold nonemergency eviction hearings u eviction orders cannot be issued and existing orders are stayed x eviction cases are not sealed or masked u law enforcement cannot enforce an order to remove a tenant if issued for a non-emergency reason u eviction prevention measures extend past the end of the state of emergency u utilities under the jurisdiction of the department of public utilities cannot shut off service due to nonpayment of bills x orders do not give a grace period to pay past-due rent x orders do not prohibit reporting of missed payments to credit bureaus u foreclosure proceedings are blocked x landlords can still charge late fees x landlords are not prohibited from raising rent u new funding is made available for statewide rental assistance programs x tenants are not guaranteed counsel in eviction cases the massachusetts housing policy regime was highly effective at reducing eviction filings. the boston eviction tracking system site – which covers the greater boston area as far north as revere, as far south as west roxbury, and as far west as newton – only saw one or two eviction filings per week during the 131. this chart summarizes all statewide measures in force in massachusetts on may 1, 2020. 270 indiana health law review [vol. 18:243 effective dates of the massachusetts law, with a few outliers of up to five filings and one week with sixteen filings near the end of the effective dates.132 in august 2020, landlords filed eleven eviction filings in boston; in a typical year, one would expect to see around 780 eviction filings.133 massachusetts also made significant investments in rental assistance programs for low-income renters.134 according to the nlihc database of covid-19 rental assistance programs, statewide assistance programs received an influx of $125 million to support households earning up to 80% of the area median income (“ami”) that had experienced financial hardship due to the pandemic.135 dozens of cities additionally created new funds for covid-19 rental assistance with different requirements for assistance and payments covered.136 on october 17, 2020, the massachusetts law expired, and the overall statewide policy regime dropped to a 0.5-star ranking – all scored supports removed except for the new funding for rental assistance.137 as of november 30, 2020, no new statewide measures have been implemented by the massachusetts legislature, executive branch, or judicial system that would raise the state’s score on the scorecard. a few isolated supports remained in massachusetts cities, like a ban on filing eviction cases against residents of public housing in boston138 or bans on eviction enforcement in cambridge and somerville that had been implemented prior to the law and remained afterward.139 in massachusetts, landlords are required to issue a two-week notice to quit prior to filing for eviction,140 so landlords could not file to evict through the end of october 2020. during the first three weeks of november 2020, landlords filed 171 eviction cases in the greater boston area alone.141 this number is about half of the caseload that one would expect to see for the first three weeks of november, in this area and in a typical year.142 that said, these are not normal 132. eviction tracking system, supra note 116. 133. id. 134. id. 135. state and local rental assistance, nat’l low income housing coalition, https://nlihc.org/rental-assistance [https://perma.cc/ne7w-rpha] (last visited mar. 24, 2021); see nat’l low income hous. coal., nlihc covid-19 rental assistance database, google, https://docs.google.com/spreadsheets/d/1hlfybfo9nydiptqu5wghupkxecimh3gaoqt7lu1jgc 8/edit#gid=79194074 [https://perma.cc/mvd3-ung2] (last updated mar. 24, 2021). 136. see generally state and local rental assistance, supra note 135. 137. covid-19 housing policy scorecard, supra note 56. 138. press release, mayor martin j. walsh & the bos. hous. auth., supra note 117. 139. cambridge amends emergency temporary eviction enforcement order and creates requirements for showings of occupied dwelling units, city cambridge (july 23, 2020), https://www.cambridgema.gov/covid19/news/2020/07/cambridgeamendsemergencytemporarye victionenforcementorder [https://perma.cc/aq6z-utj8]; see somerville issues eviction moratorium, orders unit showing to cease, supra note 124. 140. mass. gen. laws ch. 186, § 11 (2021). 141. eviction tracking system, supra note 116. 142. id. 2021] residential eviction and public housing 271 times, so a 50% reduction may not be an appropriate metric for success. rather than compare to a typical year, the november filings can be compared to the month prior. in october 2020, landlords filed thirty-eight cases.143 despite there being no significant improvement in the pandemic or economic recovery between october and november 2020 that would make it possible for more massachusetts residents to pay rent,144 massachusetts policymakers permitted the eviction caseload to increase by at least 450%.145 b. austin, texas eviction-limiting actions in texas were issued from the texas supreme court. on march 19, 2020, the court suspended proceedings in eviction cases and stayed execution of writs until mid-april.146 these provisions were later extended until may 18, 2020, and may 25, 2020, respectively, and were not extended or reissued after the may expirations.147 the texas supreme court also issued directives designed to ensure compliance with the federal cares act and cdc eviction moratorium.148 in late september 2020, the state also made available $171 million, mostly in funding from the cares act, for an eviction diversion program, which would pay off up to six months of back rent for eligible renters whose landlords filed to evict them.149 143. id. 144. see press release, exec. office of labor & workforce dev., massachusetts weekly unemployment claimant data 11-12-20 (nov. 12, 2020), https://www.mass.gov/news/ massachusetts-weekly-unemployment-claimant-data-11-12-20 [https://perma.cc/b7qr-m2xt]; see generally mass. dep’t of pub. health, massachusetts department of public health covid-19 dashboard weekly covid-19 public health report 3-23 (2020), https://www.mass.gov/doc/weekly-covid-19-public-health-report-november-27-2020/download [https://perma.cc/56xl-qmrv]. 145. eviction tracking system, supra note 116. 146. texas renters cannot be evicted at least until april 19, state supreme court says, cbs dfw (mar. 31, 2020), https://dfw.cbslocal.com/2020/03/31/texas-renters-evicted-state-supremecourt/ [https://perma.cc/w4jz-fpa3]. 147. order prohibiting residential evictions in texas extended through may 18, cbs dfw (apr. 29, 2020), https://dfw.cbslocal.com/2020/04/29/order-prohibiting-evictions-texas-extendedmay-18/ [https://perma.cc/4vrk-sxzm]. 148. tex., fifteenth emergency order regarding the covid-19 state of disaster, 20-9066 (may 14, 2020), https://www.txcourts.gov/media/1446543/209066.pdf [https://perma.cc/ha3v9852]; tex., twenty-fifth emergency order regarding the covid-19 state of disaster, 20-9109 (sept. 17, 2020), https://www.txcourts.gov/media/1449728/209109.pdf [https://perma.cc/qpn4z726]. 149. tex., twenty-seventh emergency order regarding the covid-19 state of disaster, 209113 (sept. 25, 2020), https://www.txcourts.gov/media/1449812/209113.pdf [https://perma.cc/ 276p-am4g]; juan pablo garnham, texas will spend $171 million in federal coronavirus relief funds to help renters avoid evictions, tex. trib. (sept. 25, 2020), https://www.texastribune. org/2020/09/25/texas-rent-help-evictions/#:~:text=texas%20is%20using%20%24171% 20million,fund%20legal%20services%20for%20texans [https://perma.cc/265c-ajrz]. 272 indiana health law review [vol. 18:243 on the local level, travis county and the county seat, the city of austin, implemented more extensive eviction moratoria that worked in tandem to stop pandemic evictions. on march 26, 2020, the austin city council adopted an ordinance requiring landlords to offer a sixty-day grace period to tenants who had not paid rent on-time prior to issuing a notice to vacate; this ordinance has been extended multiple times, and currently is set to expire at the end of 2020.150 the same day, in a separate order, the mayor of austin prohibited the issuance of notices to vacate for non-emergency eviction cases.151 this order has been extended multiple times.152 though in the extension issued on september 30, 2020 the order was narrowed to apply only to nonpayment of rent cases where the monthly rent of the unit is $2,475 or less or the tenant is qualified for protection under the cdc eviction moratorium.153 such is currently set to expire at the end of 2020.154 the county judge and justices of the peace further issued orders limiting evictions, beginning in the spring.155 these orders were nearly identical to the city orders in scope, only differing in the specific actions prohibited in accordance with the bodies’ different jurisdictions. as such, the order from the county judge built upon the relevant texas supreme court order, incorporating the order, adding provisions prohibiting issuance of notices to quit and enforcement of writs, and instituting a penalty for noncompliance with the order.156 the order has been extended multiple times simultaneously with the separate city of austin executive order; when the order was re-issued on september 30, 2020, to extend protections through the end of the year, it was narrowed to only prohibit the specified eviction actions in nonpayment of rent cases where the monthly rent of the unit is $2,475 or less or the tenant is qualified for protection under the cdc 150. alyssa gourd, austin city council extends renter protections related to eviction notices through dec. 31, kxan (sept. 17, 2020), https://www.kxan.com/news/local/austin/austincity-council-extends-ren ter-protect ions-related-to-evict ion-notices-through-dec31/#:~:text=my%20personal%20information-,austin%20city%20council%20extends%20renter% 20protections%20related%20to%20eviction%20notices,31&text=austin%20(kxan)%20% e2%80%94%20on%20thursday,issue%20a%20notice%20to%20vacate [https://perma.cc/m2j8t4ln]. 151. christopher neely, austin’s multilayered eviction protections to be extended until at least march, leaders say, community impact newspaper (dec. 10, 2020), https://community impact.com/austin/central-austin/coronavirus/2020/12/10/austins-multilayered-eviction-protectionsto-be-extended-until-at-least-march-leaders-say/ [https://perma.cc/mm23-ysel]. 152. see id. 153. kut staff, covid-19 latest: city of austin extends ban on evictions through the end of 2020, kut (sept. 30, 2020), https://www.kut.org/health/2020-09-30/covid-19-latest-city-ofaustin-extends-ban-on-evictions-through-the-end-of-2020 [https://perma.cc/jbyv-yhj2]. 154. id. 155. kate goodrich & jackson walker, evictions in travis country suspended through the end of the year due to covid-19, jd supra (oct. 5, 2020), https://www.jdsupra.com/legalnews/ evictions-in-austin-travis-county-61870/ [https://perma.cc/w2f8-9m3k]. 156. see id. 2021] residential eviction and public housing 273 eviction moratorium.157 very similarly, the justices of the peace for travis county issued a standing order prohibiting non-emergency eviction cases from being heard, any writs of possession from being issued, and any previously-issued writs of possession from being executed. this order has been extended multiple times; when the order was re-issued on september 24, 2020, it was narrowed to only prohibit the specified eviction actions in nonpayment of rent cases where the monthly rent of the unit is $2,475 or less or the tenant is qualified for protection under the cdc eviction moratorium.158 table 2: local and state eviction-prevention measures effective in travis county, texas on september 1, 2020 initiation court process enforcement short term supports tenancy preservation u landlords cannot give notices to quit u landlords cannot file to evict for nonemergency reasons u court deadlines are tolled u courts cannot schedule or hold non-emergency eviction hearings u eviction orders cannot be issued and existing orders are stayed x eviction cases are not sealed or masked u law enforcement cannot enforce an order to remove a tenant if issued for a non-emergency reason x eviction prevention measures do not extend past the end of the state of emergency u utilities under the jurisdiction of the department of public utilities cannot shut off service due to nonpayment of bills u orders give a grace period to pay past-due rent x orders do not prohibit reporting of missed payments to credit bureaus x orders do not block foreclosure proceedings x landlords can still charge late fees x landlords are not prohibited from raising rent u new funding is made available for statewide rental assistance programs x tenants are not guaranteed counsel in eviction cases in total, three different bodies in the austin-travis county area issued 157. see id. 158. see id. 274 indiana health law review [vol. 18:243 separate, overlapping eviction moratoria. these eviction moratoria overlapped with the statewide eviction moratorium temporally and in terms of scope but extended past the state moratorium in both respects as well. in other words, the local moratoria lasted longer and included additional protective measures. the result is a coherent and nearly water-tight eviction moratorium. between the time that the first eviction moratorium (the texas supreme court order) went into effect on march 19, 2020, and the most recent date with data available as of this writing, only 617 eviction cases have been filed in travis county, or about sixteen per week.159 this is higher than the number of evictions per week in boston during the massachusetts eviction moratorium, but still constitutes a decline in case volume of more than 90% relative to a typical year. the city of austin operated two emergency financial relief assistance programs: (1) relief in a state of emergency (“rise”), which was funded at $15 million for round one and $10 million for round two; and (2) relief for emergency needs for tenants (“rent”), which was funded at $1.2 million for round one and $17 million for round two.160 rise offered direct financial support: $2000 grants to people living in austin and travis county whose household income was below 200% of the federal poverty line, who had experienced financial impact due to covid-19, and who had not received more than $1000 in assistance from another source in the past month.161 eligible households who applied in the one-week window for the second round were chosen to receive the money by lottery,162 as even a pot of $10 million was not enough to go around.163 applications for the program closed in september 2020;164 as of the end of november 2020, there has not been a third round of rise. rent offered traditional rental assistance: money paid to the landlord for rent.165 applications for the first round of funding were accepted for a week in early may 2020.166 the second round, with more than ten times the funding, 159. eviction tracking system, supra note 116. 160. see nat’l low income hous. coal., supra note 135. 161. covid-19 relief in a state of emergency (rise) fund, city austin, http://www. austintexas.gov/article/covid-19-relief-state-emergency-rise-fund [https://perma.cc/8sxb-56vr] (last visited dec. 3, 2020). 162. id. 163. see id. 164. kut staff, covid-19 latest: austin reopens relief grant program for nonprofits, hutto to offer free testing, kut (sept. 21, 2020), https://www.kut.org/health/2020-09-21/covid19-latest-austin-reopens-relief-grant-program-for-nonprofits-hutto-to-offer-free-testing [https://perma.cc/38ul-j2ur]. 165. rent assistance for austin tenants affected by covid-19, housing authority city austin, https://austin.covidrenthelp.org/home/faqs [https://perma.cc/pp8m-zfw2] (last visited dec. 4, 2020). 166. andy jechow & jerry quijano, city providing $1.2 million in rental assistance for austinites affected by the pandemic, kut (may 1, 2020), https://cbsaustin.com/news/local/city-ofaust in -issu ing-12m-in-residen tial-rental-assistance-am id-coronavirus-pandemic [https://perma.cc/6858-hpf8]. 2021] residential eviction and public housing 275 opened for applications in august 2020.167 for both rounds, tenants needed to have a household income of less than 80% of the ami and demonstrate a negative financial impact from covid-19 to be eligible, but the precise geographic boundaries of where one needed to live to receive aid shifted between the first and second rounds.168 as of the end of november 2020, the application (available in nine languages) is still open for rent 2.0, which in october 2020 was expanded from paying up to three months of rent to covering up to six months of rent.169 the application has remained open because the city has struggled to get the money out the door.170 by contrast, in neighboring san antonio, city officials estimated in late september 2020 that they would exhaust $50 million in rental assistance funding by the end of that month.171 an october 2020 memorandum to austin city council members makes clear the significance of six months of rent payments: the average household income of an applicant for rent was just $15,000.172 still, landlords could opt out of the program. if a landlord refused to participate, or simply did not fill out the paperwork within forty-eight hours of being contacted by the program administrators, the tenant would not receive assistance.173 despite challenges like slow rent relief payments, austin’s covid-19 housing response has been remarkable for its scope and comprehensiveness. texas’s statewide moratorium expired in may 2020 and never included a filing ban, but in travis county, tenants have continuously been protected from eviction filings since april 2020. unlike the state eviction diversion program, which requires tenants to have received an eviction filing (one that might follow them for years regardless of the outcome of the case) in order to apply for six months of assistance, austin’s rent relief program permits tenants to pay rent before the situation progresses to a court filing. austin’s response should serve as a model for other local governments to follow in keeping their residents housed, particularly in states with weak or nonexistent state-level eviction167. audrey mcglinchy, the city’s got millions to help austinites pay rent, but giving it away is harder than expected, kut (oct. 22, 2020), https://www.kut.org/austin/2020-10-22/thecitys-got-millions-to-help-austinites-pay-rent-but-giving-it-away-is-harder-than-expected [https://perma.cc/ur9u-aln7]. 168. arden ward, city of austin launches $17m rent relief plan amid coronavirus crisis, culturemap austin (aug. 17, 2020), https://austin.culturemap.com/news/city-life/08-17-20-cityof-austin-launches-17m-rent-relief-plan-amid-coronavirus-crisis/ [https://perma.cc/t2lm-ds78] 169. audrey mcglinchy, concerned that money will go unspent, austin makes changes to its rent help program, kut (nov. 2, 2020), https://www.austinmonitor.com/stories/2020/11/ concerned-that-money-will-go-unspent-austin-makes-changes-to-its-rent-help-program/ [https://perma.cc/l2wp-7nms]. 170. id. 171. garnham, supra note 149. 172. memorandum from rosie truelove, dir., hous. & planning dev., to mayor and council members (oct. 30, 2020), http://www.austintexas.gov/edims/pio/document.cfm?id=349480 [https:// perma.cc/cr3j-4s5b]. 173. covid-19 relief in a state of emergency (rise) fund, supra note 161. 276 indiana health law review [vol. 18:243 blocking emergency policies and programs. c. federal interventions 1. cares act the federal cares act, which was signed into law on march 27, 2020, included several key supports that helped to reduce the number of eviction cases filed in the united states during the pandemic.174 first, the cares act included an eviction moratorium that protected millions of renting households from eviction filings between march 27, 2020, and july 25, 2020.175 second, the act appropriated funding to help renters stay current on rental payments, specifically an extra $600 per week to supplement state unemployment benefits, other expanded unemployment insurance provisions, a one-time payment of $1200 (enough to cover one month of median rent in the vast bulk of counties in the united states),176 and a large appropriation for grants that states could use for rental assistance.177 the cares act did not, however, include an enforcement mechanism or a penalty for landlords who violated the order. it also did not establish clear or comprehensive national standards for how rental assistance programs should be administered (e.g., forbidding, recommending, or requiring that tenants be permitted to self-certify fulfillment of eligibility requirements).178 as such, the implementation of the cares act resembled a patchwork of protections across the nation. landlords could not, for the reason of nonpayment of rent, issue a notice to quit or file to evict tenants residing in covered properties for the duration of the act. following the expiration of the act, landlords were required to give a thirty-day notice to quit, meaning that the earliest that landlords could issue notices to quit to tenants in covered properties was august 25, 2020.179 put simply, “covered properties” under the cares act are any and all properties that receive federal funds or are financed by the federal government.180 however, more than a dozen specific housing programs fell under the “covered properties” definition in the act, making it challenging to determine whether any 174. coronavirus aid, relief, and economic security act, pub. l. no. 116-136, 134 stat. 281 (2020). 175. id. 176. john w. schoen & lorie konish, where your coronavirus stimulus check will go furthest, based on us rents, cnbc (apr. 1, 2020), https://www.cnbc.com/2020/04/01/whereyour-coronavirus-stimulus-check-will-go-farthest-based-on-rents.html [https://perma.cc/6qky8jnu]. 177. see the cares act provides assistance for state, local, and tribal governments, u.s. dep’t treasury, https://home.treasury.gov/policy-issues/cares/state-and-local-governments [https://perma.cc/pe3z-pklt] (last visited mar. 28, 2021). 178. id. 179. see grace gregson et al., implications of the cares act for landlords and residential tenants, jd supra (apr. 15, 2020), https://www.jdsupra.com/legalnews/implications-of-the-caresact-for-65433/ [https://perma.cc/knt3-2bp3]. 180. id. 2021] residential eviction and public housing 277 given unit was a covered property.181 while a tenant likely would know if they received a section 8 voucher, the tenant might not know if the landlord received tax credits under the low income housing tax credit program, or if the landlord’s mortgage was backed by freddie mac.182 no centralized database existed for covered properties.183 plus, the federal government could not even determine how many properties were covered, let alone which properties those were; the atlanta branch of the federal reserve estimated that anywhere between 28.1% and 45.6% of occupied units were covered properties.184 in some states, like texas as discussed above, landlords were required to certify that a unit was not “covered” by the cares act moratorium when filing to evict a tenant from that unit.185 this informed landlords about the act, which in theory created a penalty for non-compliance with the act (perjury) and aided the court in ensuring that landlords were complying with federal law. in others, such certification was not required by the court, nor was a fact-finding process to determine whether the filing was allowable under the law.186 in these places, the cares act could be a tree falling unnoticed in a forest. early evidence indicates that the cares act did prevent an unknown number of eviction cases from being filed during the effective period.187 when the cares act expired, eviction filings went up in most sites tracked on the eviction lab’s eviction tracking system that were not covered by a local or state moratorium.188 it is not possible to say, at least at this time, how many eviction filings were avoided or how many were avoided by particular provisions in the act. the supplementary unemployment insurance – the extra $600 per week for people receiving unemployment benefits – ended on august 31, 2020, coinciding with the expiration of the cares act eviction moratorium. at this point in late summer, businesses were also opening across the country, giving the impression 181. see does a new federal law protect you from eviction?, nat’l low income housing coalition., https://www.nhlp.org/wp-content/uploads/federal-tenant-notice-nhlp-ahjnlihc.pdf [https://perma.cc/6yvm-xjee] (last visited mar. 24, 2021). 182. see id. 183. sarah stein & nisha sutaria, housing policy impact: federal eviction protection coverage and the need for better data, fed. res. bank atlanta, https://www.frbatlanta.org/ community-development/publications/partners-update/2020/covid-19-publications/200616housing-policy-impact-federal-eviction-protection-coverage-and-the-need-for-better-data.aspx [https://perma.cc/kx57-8e75] (last visited nov. 30, 2020). 184. id. 185. covid-19 housing policy scorecard, supra note 56. eighteen states implemented a policy requiring landlords to certify that the unit was not subject to the cares act when filing to evict: arizona, arkansas, georgia, idaho, illinois, iowa, kentucky, maryland, michigan, new hampshire, new jersey, north carolina, oklahoma, rhode island, south carolina, tennessee, texas, and vermont. id. 186. see id. 187. hepburn & louis, supra note 1; eviction filings during and after local eviction moratoria, supra note 1. 188. id. 278 indiana health law review [vol. 18:243 that the pandemic was “over” or that it was time to return to “business as usual.” all of these factors likely played a role in the lower number of eviction filings prior to august 25, 2020, and the elevated filings numbers following that date. 2. cdc order and cdc order redux soon after the expiration of the cares act, on september 1, 2020, the cdc announced a new eviction moratorium that would be in effect from september 4, 2020, to december 31, 2020.189 the moratorium relied on a statute allowing the cdc director to take necessary measures to prevent the spread of communicable diseases when the cdc director deemed local measures to be insufficient.190 unlike the cares act, the cdc eviction moratorium did not have a financial assistance component, nor was it accompanied by new financial assistance from congress.191 the main thrust of the order is contained in a single sentence: under this order, a landlord, owner of a residential property, or other person with a legal right to pursue eviction or possessory action, shall not evict any covered person from any residential property in any jurisdiction to which this order applies during the effective period of the order.192 exceptions to the blanket ban on evictions included any cause other than nonpayment of rent.193 the order initially applied everywhere falling under the federal government’s jurisdiction except american samoa (which did not have any cases of covid-19 at the time of september 4, 2020) and states and local areas with more protective measures in place (e.g., massachusetts or austin, texas).194 whereas the cares act had covered properties – and tenants could not always determine on their own whether their unit was a covered property – the cdc order covered people, with eligibility requirements that hinged on information tenants could be expected to know about themselves, to which tenants could attest without having to provide documentation.195 to qualify for protection under the order, tenants needed to certify, generally speaking, that they expected to make less than $99,000 in 2020 and were doing their best to pay rent during the pandemic.196 the cdc order defined “eviction” and “evict” in this way: “any action by a landlord, owner of a residential property, or other person with a legal right to pursue eviction or a possessory action, to remove or cause the removal of a 189. temporary halt in residential evictions to prevent the further spread of covid-19, 85 fed. reg. 55,292 (sept. 4, 2020). 190. id. 191. see id. 192. id. 193. see id. 194. id. 195. see id. 196. id. at 55,293. 2021] residential eviction and public housing 279 covered person from a residential property.”197 on its face, this appeared quite broad. initial analysis by nlihc and some courts indicated that this would cover all parts of the eviction process controlled by the landlord, from issuing a notice to quit to requesting a writ of eviction.198 as such, the cdc moratorium would provide more substantial protection from eviction – and thus would apply – in the bulk of american states and territories. this interpretation also comported with the order’s statement of intent, which instructed that the order should be interpreted in such a way as to mitigate the spread of covid-19.199 as discussed above, for an eviction moratorium to be the most effective in preventing residential mobility and thus potential covid-19 spread, it must stop the eviction process at the earliest stage possible.200 in early october, after the eviction moratorium had already taken effect, however, the cdc issued a frequently asked questions (“faq”) flyer that stated that the order was not intended to “terminate or suspend the operations of any state or local court,” nor “prevent landlords from starting eviction proceedings.”201 the order did not clarify how permitting eviction proceedings to begin comported with the stated goal of mitigating evictions.202 rather, the order appeared to anticipate a scenario where writs of eviction would tee up at a sheriff’s office until january 1, 2021, when they would suddenly all become active at once. the faq flyer additionally clarified that landlords could challenge the veracity of tenant declarations in court and did not have to take them at face value.203 in sum, what initially appeared to be a quite strong ban on eviction filings for most tenants experiencing financial hardship due to covid-19 has turned into, at best, a half-measure: a postponement of eviction by a few months, for a few well-informed tenants who land before well-informed judges and magistrates. between the day that the cdc eviction moratorium went into effect and november 27, 2020 (the last day with data available as of this writing), 55,180 eviction cases have been filed in the twenty-seven cities included in the eviction 197. id. 198. matthew goldstein, how does the federal eviction moratorium work? it depends where you live, n.y. times (sept. 16, 2020), https://www.nytimes.com/2020/09/16/business/ eviction-moratorium-renters-landlords.html [https://perma.cc/fv39-naef]. 199. temporary halt in residential evictions to prevent the further spread of covid-19, 85 fed. reg. at 55,293. 200. id. at 55,292. 201. hhs/cdc temporary halt in residential evictions to prevent the further spread of covid-19: frequently asked questions, ctr. for disease control & prevention 1, https://www.cdc.gov/coronavirus/2019-ncov/downloads/eviction-moratoria-order-faqs.pdf [https://perma.cc/u8v2-d63z] (last visited jan. 17, 2021). 202. see temporary halt in residential evictions to prevent the further spread of covid19, 85 fed. reg. at 55,296. 203. hhs/cdc temporary halt in residential evictions to prevent the further spread of covid-19: frequently asked questions, supra note 201. 280 indiana health law review [vol. 18:243 tracking system.204 iv. a word about courts the courts’ ability to respond to the pandemic and to institute reforms that ensure improved access to justice for tenants is obviously much more limited than that of the legislatures or governors. courts, after all, do not write the law. even still, court systems have many measures available to them, depending on the powers given to courts in different states. during the pandemic, courts stopped accepting filings, stopped holding hearings, continued cases, and stayed writs and judgments.205 these emergency measures shielded tenants from immediate harm during the pandemic. some courts and judges also worked to ensure that federal emergency orders were followed and that renters and landlords were aware of the orders (e.g., sending copies of the cdc tenant declaration along with the notice of an eviction filing, requiring landlords to certify along with an eviction filing that the property in question was not covered by the cares act, or asking from the bench if the tenant was aware of or qualified for the protections in the cdc moratorium). meanwhile, other courts appeared to do little to ensure that landlords followed the federal orders.206 looking ahead, courts have many options available to them to reduce fallout from the pandemic and its accompanying economic crisis. courts can seal or mask eviction records, concealing the tenants’ names and addresses from when the case is filed onward and mitigating the harm that the record does to a tenant in later years.207 courts can create mediation programs that run alongside the eviction system and permit landlords to sit down with tenants and mediators prior to, or hopefully instead of, filing for eviction.208 courts can partner with law schools to build out housing law clinics, increasing the fraction of tenants who receive legal assistance during their case. courts can advocate for the right to counsel to be implemented in their states, cities, and counties. these are not 204. eviction tracking system, supra note 116. these twenty-seven cities are: austin, texas; boston, massachusetts; bridgeport, connecticut; charleston, south carolina; cincinnati, ohio; cleveland, ohio; columbus, ohio; ft. worth, texas; gainesville, florida; greenville, south carolina; hartford, connecticut; houston, texas; indianapolis, indiana; jacksonville, florida; kansas city, missouri; memphis, tennessee; milwaukee, wisconsin; minneapolis-st. paul, minneapolis; new york, new york; philadelphia, pennsylvania; phoenix, arizona; pittsburgh, pennsylvania; richmond, virginia; south bend, indiana; st. louis, missouri; tampa, florida; and wilmington, delaware. id. 205. covid-19 eviction moratoria & housing policy, supra note 5. 206. matthew goldstein, as evictions loom, lawyers are gearing up to help, n.y. times (aug. 24, 2020), https://www.nytimes.com/2020/08/24/business/tenants-lawyers-evictionmoratorium.html [https://perma.cc/227a-ymqk] (describing the cares act); goldstein, supra note 158 (describing the cdc eviction moratorium). 207. see, e.g., michael c. zogby & kaitlyn e. stone, a litigator’s guide to the 2020 new jersey rule amendments, nat’l l. rev. (sept. 8, 2020), https://www.natlawreview.com/article/ litigator-s-guide-to-2020-new-jersey-rule-amendments [https://perma.cc/h34m-4ekb]. 208. e.g., tokarz et al., supra note 23. 2021] residential eviction and public housing 281 extreme measures, despite how rarely the measures are taken across the country. courts must not simply leave housing to the legislature. as the emergency measures during the pandemic have shown, all branches of government have a role to play in keeping people housed in this country. v. moving forward: considering eviction system reform through health justice at some point in the near future, the last remaining eviction moratoria will end. for a brief moment in may 2020, more than half of renters were covered by some form of state eviction ban, in addition to a targeted federal ban and many local bans.209 these actions were taken as emergency steps to prevent an acute catastrophe, recognizing both that america was facing an economic meltdown and that this particular byproduct of the economic crisis would further the health crisis. as the crisis wore on, however, this early commitment to stabilizing the economic situation and preventing further negative health impacts fell to the wayside. as of this writing in november 2020, covid-19 infections are increasing at a rate greater than in march 2020, yet the vast majority of renters live in states with little or no protection from eviction (defined as states with under 1.5 stars on the scorecard). eviction courts across the country are resuming business as usual, despite the fact that the pandemic has yet to subside or that “business as usual” already represented a severe housing crisis. the pandemic forced policymakers to take dramatic, expedited action to stabilize the american rental housing market in the spring and summer. the continued pandemic forces policymakers to confront the choice of whether to return to a worsened status quo – the crises of the past few years and months – now in the middle of winter, with renters’ savings and relief aid exhausted, or whether to build long-term programs to move into a better future. physicians are guided by the hippocratic principle of “[f]irst, do no harm.”210 what if housing policy was similarly guided by a principle of first, keep people housed? eviction presents numerous health risks, yet even amidst this once-in-a-generation emergency, relief measures are designed to ward off moral hazard: executive orders forbidding eviction filings included explicit warnings that renters were still on the hook for rent; rental assistance programs designed to keep low-income families from becoming homeless included such onerous documentation and application requirements that the program staff worried that they would not be able to spend all of their federal dollars.211 these measures are haunted by a phantom unsavory tenant from whom policymakers must protect the landlord and the taxpayer. american housing policy treats rental housing first as an investment and income-generating scheme for landlords, and second as homes for renters. there is another way. the current best practice in homelessness response is 209. covid-19 eviction moratoria & housing policy, supra note 5. 210. robert h. shmerling, first, do no harm, harv. health pub. (oct. 13, 2015), https://www.health.harvard.edu/blog/first-do-no-harm-201510138421 [https://perma.cc/fg5as7sh]. 211. e.g., mcglinchy, supra note 167. 282 indiana health law review [vol. 18:243 a “housing first” policy: do not require people without housing to get sober or get a job or even just wait to secure housing for them. start with housing and supply wraparound services to support them, resolving the other issues.212 a policy of “first, keep people housed” should be even easier to implement: the population the policy serves already by definition has housing. all the policy regime must do is assist in keeping those people housed and accessing higher-quality housing. how do we keep people housed? we raise barriers to filing for eviction so that landlords must treat eviction as a tool of last resort, rather than a rentcollection strategy when a tenant misses a payment. this might look like raising filing fees, establishing a floor for nonpayment eviction claims to eliminate evictions over small sums of money, or requiring an out-of-court mediation process prior to filing. we make housing more affordable, which can look like building new housing, funding rental assistance or housing vouchers, or implementing rent control, but can also look like raising the minimum wage to a living wage. we support tenants through the eviction process by establishing the right to counsel in housing cases – guaranteeing that all people receive adequate legal counsel when their home is at risk. we mitigate the harm done by eviction by removing requirements that renters have an eviction-free record to apply for government housing assistance and sealing or masking more eviction cases. none of these policies is extreme or impossible, and nearly all can be done at the local or state level. indeed, the fact that so many states and cities, as well as the federal government, stepped up to institute extraordinary anti-eviction measures during the early days of the pandemic should indicate that where there is a will, there is a way to keep people housed. can we keep that will to keep people housed as the pandemic continues and, eventually, ends? eviction is common, quick, and traumatic. eviction is a public health crisis. eviction is at once life-altering for the tenant and routine for the landlord. none of this is inevitable. we must not allow it to remain the case. the health of our neighbors and communities depends on it. 212. see generally fact sheet: housing first, nat’l alliance to end homelessness (apr. 2016), http://endhomelessness.org/wp-content/uploads/2016/04/housing-first-fact-sheet.pdf [https://perma.cc/lv9u-cxkp]. old-age-based and disability-focused: a scoping literature review on the intersection of older persons’ rights and disability rights old-age-based and disability-focused: a scoping literature review on the intersection of older persons’ rights and disability rights yotam tolub,* sagit mor,** israel (issi) doron *** elder law and disability law have historically developed separately, with minimal interaction. however, there are many similarities and shared interests between both fields and both groups – older persons and persons with disabilities. this paper is the first attempt to comparatively analyze the legal academic publications that have addressed both disability and older persons’ rights in the last two decades. using a systematic scoping review methodology, we quantitatively analyzed 180 articles published in the last two decades in legal journals and qualitatively analyzed seventeen of these articles that directly address the relationship between both fields. this systematic review yielded a comprehensive up-to-date quantitative and qualitative picture of the relationship between disability law and elder law. our findings show that current comparative literature is one-directional, as it is ‘old-age-based’ and ‘disability-focused’. the analysis produced five elements characterizing the relationship between the two fields: similarities, differences, tension, separation efforts and bridging efforts. discussing these findings, this paper suggests two different narratives to explain the revealed relationship. one emphasizes the subtle manifestations of ageism in disability studies and disability law and ableism in gerontology and elder law. the other highlights the different histories of both fields and the human rights movements they serve. more broadly, the paper demonstrates the benefits of a systematic scoping review as an empirical methodology for comparative research generally, and specifically, the opportunities that an open dialogue between elder law and disability law provides. ————————————————————————————— * yotam tolub, ll.b. (hebrew university in jerusalem); ma in gerontology (haifa university); doctoral student at the faculty of law at the haifa university and a young researcher at the minerva center on intersectionality in aging (mcia). ** prof. sagit mor, ll.b. (tel aviv university); ll.m. (nyu law school); jsd (nyu law school). prof mor is the director of the ll.m. program in law and health at the university of haifa faculty of law, the head of the international center for health law and ethics, and the cofounder of collaborative research network on disability legal studies at the law and society association. *** prof. israel (issi) doron, ll.b. (hebrew university in jerusalem); ll.m. (washington college of law, d.c.); ph.d. (osgoode hall law school, toronto): currently prof. doron is the dean of the faculty of social welfare and health sciences at the university of haifa, and the past president of the israeli gerontological society. indiana health law review [vol. 21:311 312 table of contents introduction i. overview on disability law and elder law – parallel and intersecting lines a. disability law b. elder law c. disability law and elder law – similarities and differences ii. methodology iii. quantitative analysis a. key background characteristics of the articles b. key content description of articles c. analysis of articles content d. the overall quantitative descriptive picture iv. qualitative analysis a. key background characteristics of the articles b. common features c. the relationships between elder law and disability law 1. similarity 2. difference 3. tension 4. separation 5. bridging d. common human rights challenges 1. legal capacity 2. independent living and de-institutionalization 3. employment e. international law instruments the crpd and older persons’ rights v. discussion a. literature characteristics 1. american-based 2. normative-based 3. old-age-based and disability-focused 4. core issues b. the relationship between disability law and elder law 1. manifestation of ableism in elder law and ageism in disability law 2. contrasting approaches in elder law and disability law: exploring divergence vi. conclusion 2024] old-age-based and disability-focused 313 introduction this article presents the outcomes of a scoping literature review that examines the existing legal research comparing the rights of individuals with disabilities and older persons and the relationship between these two fields of research. the objective is to identify the current intersections between disability law and elder law and analyze their broader potential. to our knowledge, this scoping review represents the first attempt to compare the writings about the intersection between disability law and elder law through both fields’ published research. the outcomes of our review uncover an underexplored narrative concerning the connection between these two fields’ intersectional writing, which we have termed “old-age-based” and “disability-focused”. this term represents the tension between elder law and disability law as well as both fields’ potential benefit from a more direct and eye-to-eye dialogue. in part i, the article discusses the similarities and differences in the development of disability law and elder law, providing a theoretical foundation for the subsequent sections. part ii outlines the methodology employed, introducing the scoping review method and the two components used for analysis: quantitative and qualitative. part iii focuses on the quantitative analysis, drawing on a selection of 180 articles. it presents a detailed statistical examination of the current comparative legal research on disability and older persons’ rights, including the nature of the research, publication venues, specific issues addressed, and contextual frameworks. in part iv, the qualitative analysis delves into 17 articles that directly explore the relationship between the rights of older persons and people with disabilities. this chapter examines the similarities, differences, and additional patterns, such as tension, efforts toward separation, and efforts toward bridging. lastly, in the integrative part v, we engage in a comprehensive discussion of the implications of our findings from both the qualitative and quantitative chapters. in the concluding remarks, we highlight the potential and relevance of further research on the understudied connection between these two fields, impacting the daily lives of many people. i. overview on disability law and elder law – parallel and intersecting lines historically, the disability rights movement and the older persons rights movement have progressed independently with minimal interaction. consequently, it is not surprising to find significant disparities in the fields of disability law and elder law. in this part, we will examine the historical evolutions of disability law and of elder law and analyze their similarities and differences as a foundation for addressing the central inquiry of our research: how do these fields intersect? as will be demonstrated in this chapter, there is a parallel in the development of both fields, transitioning from a positivist and impartial legal perspective to a more critical and proactive approach supported indiana health law review [vol. 21:311 314 by wider theoretical frameworks. a. disability law prior to the 1970s, disability law primarily fell under the umbrella of welfare law, which addresses issues related to people with disabilities within the context of social welfare, such as rehabilitation, financial benefits, medical treatment, and social services. this approach, rooted in positivism, considered disability as a welfare matter with distinct legal aspects that should be addressed through relevant legal frameworks. 1 however, the emergence of the disability movement and the establishment of disability studies as an academic discipline during the latter half of the twentieth century reshaped disability law. understanding the foundations of disability studies is crucial for comprehending the transformations in disability law. to better comprehend disability studies it is helpful to understand the approach it sought to replace. 2 the traditional approach to disabilities as formulated by its critics was an individualist approach that viewed disability as an individual trait and a personal tragedy. 3 disability was considered an objective problem to be remedied by society through healing and rehabilitation, and when necessary by providing a social and economic safety net and special segregated frameworks developed for persons who lacked the capacity to integrate in society. 4 the medical approach to disability is related to the individual one, and it reduces the experience of illness and disability to a purely medical-clinical phenomenon. therefore, people with disabilities are considered to be sick and in need of treatment 5 resulting in medical, health and welfare professions being granted sweeping authority in all areas of their lives. 6 the social model of disability offers a completely different perspective:7 ————————————————————————————— 1. see, e.g., simi linton, claiming disability: knowledge and identity 117-131 (1998); david pfeiffer, a bit of history, 21 disability stud. q. 1 (2001); michael e. waterstone, disability constitutional law, 63 emory l. j. 527 (2014). 2. handbook of disability studies 125 (gary l. albrecht, katherine seelman & michael bury eds., 2001). 3. colin barnes & michael oliver, disability: a sociological phenomenon ignored by sociologists (1993); simon brisenden, independent living and the medical model of disability, 1 disabil. handicap & soc. 173 (1986). 4. marno retief & rantoa letšosa, models of disability: a brief overview, 74 hts theol. stud. (2018). 5. linton, supra note 1; michael oliver, the politics of disablement: a sociological approach 12-24 (1990). 6. for a brief historical context of the medical model, see jamelia n. morgan, policing under disability law, 73 stan. l. rev. 1401, 1404-14 (2021). 7. tom shakespeare, the social model of disability, in disability stud. reader 2, 197 (lennard j. davis ed., 2d ed. 2006); tony makin, the social model of disability, in counselling: the bacp counselling reader 184, 184-85 (volume 2, pat milner & stephen palmer eds., 2001); torn shakespeare & nicholas watson, the social model of disability: an outdated ideology?, in exploring theories and expanding methodologies: where we are 2024] old-age-based and disability-focused 315 disability is not inherent to individuals but rather is located in relationships and interactions between people and their surroundings. thus, disability is not an individual medical condition but the product of a longstanding social construct that includes discrimination, marginalization, oppression, and paternalism. 8 therefore, the burden of remedying this relationship rests on society. 9 a critical theory of disability not only underlines the oppression (negative) against people with disabilities but also calls for liberation (positive) by mobilizing for a common struggle, pride, and the celebration of disability as part of human diversity. 10 the emergence of disability studies, concurrent with the rise of the independent living (il) movement 11 and drawing lessons from the civil rights movement and feminist struggle, 12 played a pivotal role in shaping the development of disability law. this transformative period can be characterized as a shift from a welfare-oriented approach to a rights-based approach.13 disability law became a site for advancing equality, combating discrimination, advocating for accessibility, and promoting accommodations to include and integrate people with disabilities in all aspects of life. at the core of the rights-based approach to disability law is a deep-seated mistrust of the existing segregating welfare services. here, persons with disabilities were conceptualized as a minority group vulnerable to marginalization and discrimination. 14 under this view, the law’s role is to ————————————————————————————— and where we need to go 9, 9-28 (sharon n. barnartt & barbara m. altman eds., 2001). there are many nuanced combinations of the social model and human rights model in disability studies. see also shakespeare’s analysis of four approaches (sociology of chronic illness, british social model, american cultural disability studies (critical disability studies), nordic relational understanding of disability which he favors). tom shakespeare, disability rights and wrongs revisited (2d ed. 2013). 8. paul abberley, the concept of oppression and the development of a social theory of disability, 2 disabil. handicap & soc. 5 (1987); susan wendell, the rejected body: feminist philosophical reflections on disability 35 (1996). 9. for a comprehensive comparison of the two competing approaches, the individualistic traditional representation of disability and disability studies’ perspective, see linton’s forceful essay. simi linton, disability studies/not disability studies, 13 disability & soc. 525 (1998). the limits of the social model as a theoretic model in disability law is discussed in: adam m. samaha, what good is the social model of disability?, 74 u. chi. l. rev 1251 (2007). 10. see, e.g., john swain & sally french, towards an affirmation model of disability, 15 disability & soc. 569 (2000). 11. david l. braddock & susan l. parish, an institutional history of disability, in handbook of disability studies 11, 48 (gary l. albrecht, katherine d. seelman & michael bury eds., 2001). 12. arlene s. kanter, the law: what’s disability studies got to do with it or an introduction to disability legal studies, 42 columbia hum. rts. l. rev. 403 (2011); joseph p. shapiro, no pity: people with disabilities forging a new civil rights movement 105 (1994) . 13. samuel r. bagenstos, the future of disability law, 114 yale l. j. 1 (2004). 14. id., at 14-15. bagenstos argues that human rights activists for people with disabilities went farther than other welfare activists by rejecting welfare services for people with disabilities and not advocating for improving services. indiana health law review [vol. 21:311 316 protect the rights of this minority group, eliminate discriminatory practices, promote equality, dismantle barriers, and provide the necessary support for full inclusion and participation. 15 a landmark achievement of the rights-based approach occurred in 1990 with the passage of the americans with disabilities act (ada). 16 the ada made significant strides by emphasizing the prohibition of discrimination, promoting accessibility in various domains, and introducing accommodations to enable equal opportunities for individuals with disabilities. its success served as an inspiration for similar legislative efforts in other countries, amplifying the impact of the rights-based approach to disability law. 17 in conjunction with the rights-based approach, a more radical and critical theory of disability law emerged, known as disability legal studies (dls). 18 this theoretical framework, as identified by mor, bridges critical disability theory with critical legal theories. 19 similar to feminist legal theory, critical race theory, and queer theory, disability legal studies aim to shed light on how the law reflects, perpetuates, and establishes power dynamics and oppression between individuals with and without disabilities. this perspective challenges the notion that relying solely on existing legal structures, such as antidiscrimination laws, is sufficient in addressing the needs and rights of people with disabilities. 20 according to this third wave of disability law, there is a recognition that the existing legal framework is inadequate for ensuring the full participation and empowerment of individuals with disabilities. new doctrines and approaches are required to amplify the voices of people with disabilities, grant them agency over their own lives, and enable active engagement in the social realm. 21 one key concept that emerges within disability legal studies is “ableism,” which encompasses the socially constructed hierarchy between “able-bodied” individuals and people with disabilities. ableism is sometimes codified into law and sometimes dealt with by law for example in determining that accessibility ————————————————————————————— 15. kanter, supra note 12. see also waterstone, supra note 1. waterstone’s claim that too much effort was invested in legislation and jurisprudence for prohibiting discrimination and providing benefits or support without developing a constitutional approach to disability law. 16. americans with disabilities act (ada) of 1990, 42 u.s.c. § 12101. 17. elizabeth f. emens, disabling attitudes: us disability law and the ada amendments act, 60 am. j. compar. l. 205, 206 (2012); katharina heyer, rights enabled: the disability revolution, from the us, to germany and japan, to the united nations 5 (2015). 18. sagit mor, equal rights for people with disabilities in employment – from rehabilitation of the individual to rehabilitation of the society, 35 tel aviv univ. l. rev. 97, 100 (2012) (heb.). 19. sagit mor, between charity, welfare and warfare: a disability legal studies analysis of privilege and neglect in israeli disability policy, 18 yale j. of l. & human. 63, 67-79 (2006). 20. natalie m. chin, centering disability justice, 71 syracuse l. rev. 683, 691 (2021). 21. sagit mor, towards radicalization of disability insurance: chronicles of a struggle for social change, in l. soc. & cult. – empowerment in law 91, 124-26 (mimi aizenshtat & guy mundlak eds., 2008) (heb.). 2024] old-age-based and disability-focused 317 is a fundamental right designed to remove barriers society enacts against its members. 22 the united nations convention on the rights of persons with disabilities (crpd) is arguably the most advanced legal document to reflect the findings of critical disability legal studies. 23 the convention is firmly rooted in the framework of critical disability legal studies theory, along with the overarching model of human rights. 24 notably, it encompasses both civil and socialeconomic rights, making it one of the most comprehensive un conventions in terms of the range of issues it addresses and the practical tools it provides . 25 let us now turn to elder law and examine its theoretical development. b. elder law elder law emerged in the united states in the late 1970s and was centered around the clinical aspects of legal practices in this field. 26 the lack of adequate legal mechanisms to meet the needs of older people required a development of new legal instruments to contend with the unique needs of older people. this led the way to a newly recognized specialization. 27 during these years, elder law was positivist and eclectic by nature, split into topics and areas, such as: agebased discrimination, asset planning, medicaid/medicare law, legal competency, protective labor law, wills and estate planning, and more. this first stage was characterized by the absence of an over-arching organizing theory, very little interdisciplinary research (and even estrangement from the field of gerontology) and few empirical studies in the field. 28 but more than anything else, elder law’s early positivist approach responded to the existing needs using systems that were based on the existing legal paradigms. it made no attempt to envision an alternative, nor did it critically examine the role of the law in sustaining the dominant paradigm, and naturally ————————————————————————————— 22. gregor wolbring, the politics of ableism, 51 dev. 252, 253 (2008); kathleen r. bogart & dana s. dunn, ableism special issue introduction, 75 j. of soc. issues 650, 652 (2019); fiona a. k. campbell, inciting legal fictions: disability’s date with ontology and the ableist body of the law, 10 griffith l. rev. 42, 43 (2001). 23. u. n. convention on the rights of persons with disabilities (2007). 24. theresia degener & maría gómez-carrillo de castro, toward inclusive equality: ten years of the human rights model of disability in the work of the un committee on the rights of persons with disabilities, in disability law and human rights: theory and policy 27 (franziska felder, laura davy & rosemary kayess eds., 2022). 25. arlene s. kanter, the development of disability rights under international law: from charity to human rights 7 (2014). 26. israel doron, 25 years of elder law: an integrative and historical account of the field of law and aging, 21 theoretical inquiries l. 1, 3 (2019). 27. allan d. bogutz, elder law: a personal perspective, in theories on law and ageing: the jurisprudence of elder law 1 (israel doron ed., 2009); lawrence a. frolik, the developing field of elder law: a historical perspective 1 elder l.j. 1 (1993). 28. israel doron, a multi-dimensional model of elder law, in theories on law and ageing: the jurisprudence of elder law 59 (israel doron ed., 2009). indiana health law review [vol. 21:311 318 it did not try to replace it. 29 new and significant changes began in the 1990s with innovative empirical research in elder law; elder law transcended the boundaries of the united states and was incorporated into international law and regional contexts (africa, south america and europe), 30 as well as various theoretical approaches, such as the therapeutic approach, a law and economics approach, the feminist approach, a multidimensional model, and others. 31 this second stage in the development of elder law was characterized by an effort to apply existing legal theories without formulating a broad and unique theory grounded in aging. a more radical and critical approach to elder law emerged during the first decade of the millennium, addressing old age as a social construct and lamenting the elimination of unique identities in the classic discourse on elder law. it seeks to focus on the unique experience of certain groups who are older people and envisions a new legal reality which remedies existing injustices. 32 in this context, kohn, for example, presented three questions which she argued that this new approach seeks to examine: how does the law define old age and how can it aid aging successfully and intergenerational justice; how can it guarantee support and solutions suitable for the needs and interests of older persons; and what is the legal significance of age, meaning when—if at all—and how should the law treat the category of age (such as for affirmative action based on age). 33 under this new legal scholarship, older persons were thus viewed as a social group subject to ageism, i.e. stereotyping, social prejudices and discrimination based on chronological age or on perceptions of old age overtly or covertly. 34 similarly to ableism in the disability context, ageism is manifested both in societal attitudes and in discriminatory and exclusionary practices embedded in law. 35 finally, in an attempt to transcend sociological characteristics of ageism, elder law was framed not only in new and critical approaches, but also in new ideological forms. for example, doron suggested the term ageivism to describe the current need for an elder rights movement based on political, social and economic principles of identity, respect and social justice. 36 ————————————————————————————— 29. dafna hacker, elder law and its justifications: a hybrid vision inspired by family law jurisprudence, 21 theoretical inquiries l. 25, 27 (2020); nina a. kohn, a framework for theoretical inquiry into law and aging, 21 theoretical inquiries l. 187, 198 (2020). 30. diego rodriguez-pinzón & claudia martin, the international human rights status of elderly persons, 18 am. u. int’l l. rev. 915 (2003); israel doron, from national to international elder law, 1 j. int’l aging l. & pol’y 43 (2005). 31. doron, supra note 26. 32. sue westwood, i may be older, but i ain’t no ‘elder’: a critique of ‘elder law’, 21 temple pol. & civ. rts. l. rev. 485 (2012). 33. kohn, supra note 29. 34. thomas nicolaj iversen, lars larsen & per erik solem, a conceptual analysis of ageism, 61 nordic psych. 4 (2009). 35. robert n. butler, ageism: a foreword, 36 j. soc. issue 8 (1980); israel issi doron et al., ageism and anti-ageism in the legal system: a review of key themes, in contemporary perspectives on ageism 303 (liat ayalon & clemens tesch-römer eds., 2018). 36. israel doron, re-thinking old age: time for ageism, 27 hum. rts. def. 33 (2018). 2024] old-age-based and disability-focused 319 c. disability law and elder law – similarities and differences as we have observed, there are notable distinctions between disability law and elder law. while the critical perspective is predominant in disability studies, prominent approaches in elder law do not necessarily emphasize the social construct and marginalization of old age, often leaning toward a positivist and liberal approach. while both elder law and disability law share a common focus on stigma and discrimination, they differ in their approaches. elder law emphasizes the use of anti-discrimination tools and equal rights while disability law addresses the rights to access and to inclusion based on the principles of the social model.37 elder law, primarily developed by legal professionals and scholars who may not have been older persons themselves, 38 differs from disability law, which has been significantly influenced by the activism and literary contributions of individuals with disabilities, emphasizing the principle of “nothing about us without us.”39 furthermore, while disability law has undergone transformative changes, particularly in the form of comprehensive equal rights for individuals with disabilities and the un convention on disability rights, these changes have yet to be fully or extensively applied to elder law. 40 despite these differences, there are conceptual commonalities and overlaps between the two fields. 41 first and foremost, both groups are engaged in a struggle for the recognition of their fundamental human rights. individuals with disabilities and older people face a heightened risk of having their human rights curtailed or even eradicated, including the rights to liberty, equality, and legal capacity. 42 shared struggles for human rights serve as the initial and central connection between disability and old age. in addition, both fields consider the role of social constructs based on stigma, discriminatory approaches and wrongful assumptions and their influence on both groups of people. in disability theory this is termed ableism ————————————————————————————— 37. doron et al., supra note 35. an interesting comparison between elder law and disability law in terms of strategies to combat ageism/ableism can be found in: annika taghizadeh larsson & håkan jönson, ageism and the rights of older people, in contemporary perspectives on ageism 369 (liat ayalon & clemens tesch-römer eds., 2018). 38. frolik, supra note 27. 39. richard k. scotch, “nothing about us without us”: disability rights in america, 23 oah mag. hist. 17 (2009) . 40. israel doron & itai apter, the debate around the need for an international convention on the rights of older persons, 50 gerontologist 586, 586 (2010); israel doron, elder law: current issues and future frontiers, 3 eur. j. ageing 60 (mar. 2006). 41. sagit mor, law fac., haifa u., comment address at the elder law and its discontents conf. at the cegla ctr. for interdisc. rsch. of the law, tel aviv u. (june 19, 2018). see hacker, supra note 29 (distinguishing elder law from disability law as a response to this overlap). 42. arlene s. kanter, the united nations convention on the rights of persons with disabilities and its implications for the rights of elderly people under international law, 25 ga. st. u. l. rev. 527, 527 (apr. 1, 2009). indiana health law review [vol. 21:311 320 and in elder theory it is termed ageism, and these are more similar than different. 43 the significance is that any policy analysis concerning persons with disabilities and older persons must strive to expose social, legal, and historical circumstances which have shaped the conditions these groups face. limiting research to examining the needs of these populations and to ways for addressing these needs without considering external circumstances is partial and therefore unjust. moreover, international law is assuming more of a central role in developing the rights of persons with disabilities and older persons. 44 the un convention on the rights of persons with disabilities demonstrates the power of international law to shape the lives of persons with disability by raising awareness and changing legislation. the international perspective is crucial as international law expands to address more areas and deepens its grip on domestic law45 in a world that must contend with global demographic challenges of aging population and an increasing number of persons with disabilities, and where international and multinational knowledge have become readily accessible. 46 finally, people with disabilities live longer (aging with disability) and older persons acquire disabilities (aging into disabilities). there is a growing group of people that are both persons with disabilities and elder persons. 47 therefore, there is an increasing need, opportunity, and potential for a dialogue between both fields. in summary, it is evident that the legal context offers numerous potential intersections between disability and age. nevertheless, the existing academic literature lacks a comprehensive examination of these intersections. therefore, this study, the first of its kind, aims to address this scholarly gap by conducting a systematic review and analysis of the evolving relationship between disability and age. ii. methodology scoping reviews have been used increasingly over the past fifteen years for mapping areas of research. such reviews are designed to determine the scope of literature in the field and conceptualize core theories in the existing research. ————————————————————————————— 43. christine overall, old age and ageism, impairment and ableism: exploring the conceptual and material connections, 18 nwsa j. 126, 126 (2006). 44. gerard quinn, the united nations convention on the rights of persons with disabilities: toward a new international politics of disability, 15 tex. j. cl & cr 33 (apr. 17, 2009); doron, from national, supra note 30. 45. daphne barak-erez, the international law of human rights and constitutional law: a case study of an expanding dialogue, 2 int. j. const. l. 611, 614 (oct. 2004). 46. benny spanier et al., older persons’ use of the european court of human rights, 28 j. crosscult. gerontol. 407, 407 (oct. 20, 2013). 47. the aging–disability nexus 3 (katie aubrecht, christine kelly & carla rice eds., 2020). 2024] old-age-based and disability-focused 321 scoping reviews are suitable for the preliminary stage of developing the area when it is still too early for a systematic literature review which also assesses the research methods and the empirical findings. scoping reviews are used to identify the existing data, clarify central terms, examine how research is designed and managed in a certain field, identify themes and central characteristics, and point to gaps. 48 scoping reviews are particularly well suited for policy-oriented research and are frequently used to lay the groundwork for more focused research in the future. scoping reviews are most commonly use to map the existing literature in a certain field, and this is how it is being used here.49 the most notable model for conducting a scoping review was developed by arksey and o’malley and it includes five stages: formulating the research question; locating relevant research using various information sources; sampling the studies using inclusion and exclusion parameters that arise during the process of reading and gaining a more profound understanding of the literature; organizing information by arranging it according to themes and central issues by coding and narrative descriptions; and processing and synthesizing knowledge by way of comparison, conclusion and presenting the findings.50 for this research, the “population group” (and inclusion criteria) is all the articles published over the past decade (2009–2021)51 in law reviews and journals that discuss specific or general legal issues while addressing or mentioning their implication on both persons with disabilities and older people. the search strategy required at least five mentions of the following three components: older people, persons with disabilities, and policy/rights. 52 searches were conducted using the web-based legal database westlaw us, complemented by searches in westlaw international and google scholar. the search results included 377 initial articles. initial search results were sorted in two stages: first by title and abstract and then by full text. after reading the abstracts, 197 of the articles were filtered out: 112 because of their unrelated topics, forty-nine were on medicaid or medicare, twenty-four were on caregivers and the remaining were drawn out due to technical reasons (they were not law review articles, or they were duplicates). 180 articles were left for the ————————————————————————————— 48. zachary munn et al., systematic review or scoping review? guidance for authors when choosing between a systematic or scoping review approach, 18 bmc med. rsch, method. 1, 2 (2018). 49. phillip d. rumrill et al., using scoping literature reviews as a means of understanding and interpreting existing literature, 35 work 399, 401 (2010). 50. hilary arksey & lisa o’malley, scoping studies: towards a methodological framework, 8 int’l j. soc. rsch. method. 1, 19 (2005); kathy davis, et, what are scoping studies? a review of the nursing literature, 46 int’l j. nursing stud. 1386 (mar. 27, 2009) . 51. the search was conducted in june 2021. 52. (atleast5(elderly) or atleast5(“senior citizen”) or atleast5(“senior citizens”) or atleast5(“older people”)) and (atleast5(disability!) or atleast5(disable!)) and (atleast5(rights) or atleast5(policy)). indiana health law review [vol. 21:311 322 quantitative research. the research methodology included two components: quantitative and qualitative. quantitative research was undertaken by coding the articles included in the final sample and quantifying the data to form a statistical dataset. coding included the research’s characteristics (discipline, methodology, geographical location), publication characteristics (type of publication, publication year, authors), the population’s characteristics (characteristics of disabilities and characteristics of old age), the article’s core topic and the nature of the relationship between disabilities and old age, as well as type of research. qualitative research focuses on seventeen articles that directly addressed the comparison between disability and old age and vice versa, as will be later explained in part iv. thematic content was analyzed based on identifying and extracting central theories in the various research, as well as their central arguments. this analysis was based on the substantive content in the articles and based on in-depth and repeated reading by the research team, as well as by creating criteria for identifying and defining the various arguments in the articles. we will now describe the quantitative analysis, its findings, and a discussion of its findings, followed by the quantitative analysis, its findings and an integrative discussion of the issues that arose. iii. quantitative analysis as described above, the scoping review yielded a sample of 180 articles that addresses both disability rights and older persons rights. in the following we provide an analysis of this sample on two different levels: a descriptive quantitative level, and a qualitative analysis level. we begin with the quantitative analysis. a. key background characteristics of the articles the analysis of the background characteristics of the articles found that 85% of the articles were of an academic nature, while 12% were non-academic, appearing in non-refereed or popular publications. furthermore, 88% of the articles were published in the united states, reflecting a predominant focus on the domestic legal landscape. among the selected articles, approximately seventy-six percent concentrated on national-level issues, with 13% addressing state or regional matters, particularly in states such as texas, illinois, and new york. around 8% of the articles adopted an international perspective. the temporal distribution of publications revealed a notable trend, with half of the articles published between 2009 and 2014, and the remaining half between 2015 and 2021. notably, two peak years of interest emerged: 2009 and 2017, followed by a subsequent fluctuation in attention over the years (see chart 1). on a broader scale, the long-term pattern suggests a decline in publications within 2024] old-age-based and disability-focused 323 this field. chart 1 – publication year the sources utilized in this research exclusively comprised legal and policy papers. within this category, approximately 56% of the articles were published in general academic legal journals, encompassing a range of legal disciplines rather than being specifically focused on disability or elder law. the remaining 44% were specialized academic journals, with 10% specifically centered on elder law, while others explored topics such as human rights, health, race, gender, class, finance, and international human rights (see chart 2). it is worth noting that there are no journals dedicated to disability and law, which attests to the marginalized status of the field in legal research. chart 2 – sub-discipline of journal b. key content description of articles upon coding for key legal topics and issues, we found twenty distinct subjects at center of the articles. notably, the concept of legal capacity emerged as the most prevalent topic, accounting for 12% of the articles (see chart 3). 24 11 10 18 16 9 14 13 21 16 8 14 6 0 10 20 30 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 publication year 56.1 10.0 4.4 5.0 4.4 6.7 4.4 8.9 0.0 10.0 20.0 30.0 40.0 50.0 60.0 sub-discipline of journal (percentage) indiana health law review [vol. 21:311 324 chart 3 – main issue through the process of clustering the various issues, a more distinct understanding of the dominant themes has emerged. two prominent themes, namely personhood (encompassing legal capacity, voting, legal representation, and citizenship) and independent living and inclusion (encompassing housing, discrimination, long-term care, accessibility, socio-economic rights, and deinstitutionalization), come into focus (see chart 4). additionally, the topic of protection, encompassing protective measures, emergencies, and covid-19, also received attention. 0 5 10 15 20 25 le ga l c ap ac it y o th er h o u si n g v o ti n g so ci o -e co n o m ic r ig h ts lo n g te rm c ar e p ro te ct iv e m e as u re s st ig m a an d d is cr im in at io n en d o f lif e in ca rc er at io n in te rn at io n al c o n ve n ti o n s em er ge n ci es a cc es ib ili ty c o n ce p tu al le ga l r ep re se n ta ti o n c o m p an io n a n im al s to rt l aw r et ir em en t c o vi d -1 9 c it iz en sh ip 23 16 15 13 13 12 11 11 10 8 7 6 6 6 5 5 4 3 3 3 main issue 2024] old-age-based and disability-focused 325 chart 4 – main theme the majority of articles included in our research adopt a normativeargumentative approach (70%), wherein a legal issue is addressed, its shortcomings are identified, and suggestions for improvement are proposed. these articles do not incorporate empirical investigations as part of their methodology. a smaller proportion of articles are descriptive (10%), primarily focusing on providing an overview of the current situation. another portion (14%) takes a critical perspective, employing a critical lens to comprehend and interpret the legal landscape. only a small percentage of articles (4%) are theoretical in nature, establishing a theoretical foundation on disability or elder law. it is noteworthy that a significant portion of the articles (59%) do not explicitly state or rely on a single theoretical framework, while the remaining articles discuss or reference a diverse range of theoretical frameworks (24% primarily referencing civil rights theory and 17% citing other theories such as distributive justice, disability studies, vulnerability, critical thinking, and therapeutic justice). when identifying the population at center in the articles we can see that older persons (22%) or people with disabilities (18%) were at the center of less than half of the articles. in 12% of the articles the population at center was intersectional mostly referring to people aging into disability such as dementia and only one article focused on people aging with disability. 53 in 19% of the articles, both populations were equally referenced, typically in articles that concentrated on a specific subject relevant to both groups. the largest category of population at the center (24%) was broader groups, such as vulnerable populations or individuals living in poverty, which included both people with disabilities and older persons. the majority of articles did not specifically focus on particular disabilities (76%), with the sole major sub-category of disability being “mental disability” (13%), which included individuals with diminished ————————————————————————————— 53. william n. myhill & peter blanck, disability and aging: historical and contemporary challenges, 11 marq. elder’s advisor 47 (2009). personhood 30% independent living 39% protection 13% other 18% main theme indiana health law review [vol. 21:311 326 capacity such as those with psychosocial disabilities, intellectual disabilities, dementia, and autism. approaching the core of our research, we identified three distinct relationships between older persons and people with disabilities in the articles. the primary category (72%) encompasses similar issues that are relevant to both groups, indicating overlapping concerns and challenges. the second category (19%) explores the intersectionality between older persons and disability, primarily focusing on people aging into disability and analyzing the shared needs of people with disabilities, regardless of whether their disabilities are lifelong or age-related. finally, a mere 9% of the articles directly compared the rights of older persons and disability rights. these seventeen comparative articles have been selected as the focal point for a separate qualitative research study in the subsequent chapter. c. analysis of articles content through the process of cross-tabulation, we have uncovered intriguing relationships between the various fields. when examining the frequencies of the main themes in relation to the population at the center, a distinct pattern emerges. articles centered on people with disabilities primarily focus on personhood (34%) and independent living (thirty-eight percent), while placing relatively less emphasis on protection issues (6%) (chart 5). on the other hand, articles concentrating on older persons exhibit a lower focus on personhood (10%) and a greater emphasis on protection (13%) (chart 6). chart 5 – pwd: article content personhood 34% independent living 38% protection 6% other 22% pwd 2024] old-age-based and disability-focused 327 chart 6 – older persons: article content furthermore, in articles that address both populations, the majority concentrate on themes related to personhood (40%) and independent living (51%). none of the comparative articles, when cross-tabulated with the main themes, incorporate the topic of protection (chart 7). chart 7 – comparative articles’ main themes: lastly, it is noteworthy that there is no apparent evolvement in the main themes throughout the years. articles covering all three major themes were written in equal proportions during both the periods of 2009–2014 and 2015– 2021. d. the overall quantitative descriptive picture the overall findings provide a comprehensive overview of the published personhood 18% independent living 35%protection 0% other 47% comparative articles personhood 10% independent living 32% protection 13% other 45% older persons indiana health law review [vol. 21:311 328 literature in the comparative field of disability and aging. the majority of the literature originates from the united states, primarily focusing on national-level issues. a wave-pattern is observed, with peaks in publication years occurring in 2009 and 2017. methodologically, the majority of articles take a non-empirical and normative approach, with only a small number of studies employing quantitative measurements or developing theoretical frameworks. regarding the population at the center, a diverse range of relationships between disability and older persons is evident. these relationships can be categorized into five groups, with varying proportions ranging from 12% to 24%: the marginalized population (such as poor people comprising both people with disabilities and older persons), people with disabilities in the forefront and older persons in the background, the front and older person at the back, older persons in the forefront and people with disabilities in the background, both groups in the forefront, and individuals who are aging into disability (such as those experiencing dementia). the main connection between disability and age is through common legal issues (such as voting rights), rather than the shared experience of being both old and having a disability (such as the negative social construction, stereotypes, or stigma associated with it). the findings highlight two key issues that connect disability and aging discourse: independent living and personhood. protection concerns are more prevalent in literature focused on old age and is absent in the seventeen comparative articles. in the subsequent chapter, we will delve further into the relationship between disability and aging as reflected in these comparative articles. iv. qualitative analysis following the statistical analysis of 180 articles through a scoping review, our research now transitions into a qualitative analysis focusing on a subset of seventeen articles. these selected articles were specifically chosen for their comparative nature, aiming to explore what one group can learn from the other. through this qualitative analysis, we aim to uncover current trends in disability and elder law and to understand the relationship between both fields. a. key background characteristics of the articles out of the initial pool of 180 articles examined in the quantitative chapter, our focus narrowed down to seventeen articles that were identified as comparative in nature. these selected articles delve into six distinct issues: international law, stigma and discrimination, legal capacity, theory development, housing, and reasonable accommodation. notably, none of these articles center on the topic of protection. of the seventeen articles, the majority (82%) approach disability rights from 2024] old-age-based and disability-focused 329 the perspective of elder law, seeking to explore what lessons can be gleaned from disability law. two articles adopt a thematic comparative approach, analyzing legal capacity 54 and discrimination 55 in both groups, while only one article focuses on the intersectionality of aging with disability 56 . it is worth noting that none of these articles specifically address the reverse perspective, wherein disability law learns from elder law. as indicated in the quantitative chapter, if these selected articles reflect current trends, it suggests that disability scholars generally do not perceive elder law as a source for learning within the field of disability studies. additionally, there has been criticism from the gerontology community regarding the exclusion of older individuals from the disability discourse. westwood, for instance, highlights this concern by stating: ageing as experienced by a person with a disability is an underresearched area and still needs to be put on the policy agenda. it involves in part seeing people through a single identity lens and as their disability, rather than in terms of intersecting identities. but it also involves the way disability is conceptualized. older people are routinely excluded from disability rights discourse . . . . 57 in a similar vein, another argument highlights the exclusion of older individuals from disability activism and policies, suggesting that disability movements inadvertently contribute to ageism by creating a divide between disability rights and the rights of older persons aging with and into disabilities.58 the complex tension arising from this issue will be thoroughly examined and discussed in the forthcoming chapter. additionally, our discussion will explore traces of ableism within the elder law writing. we will now turn to analyze the content of these articles and the main themes that can be extricated from them. b. common features the starting point of all seventeen articles is that there are many common features shared by older people and people with disabilities. these commonalities vary based on the standing point and topic of the research. they can be phrased from an individualistic, and partly medical, point of view such ————————————————————————————— 54. eliana j. theodorou, supported decision-making in the lone-star state, 93 n.y.u. l. rev. 973 (2018). 55. leslie pickering francis & anita silvers, bringing age discrimination and disability discrimination together: too few intersections, too many interstices, 11 marq. elder’s advisor 139 (2009). 56. myhill & blanck, supra note 53. 57. westwood, supra note 32, at 501. 58. håkan jönson & annika taghizadeh larsson, the exclusion of older people in disability activism and policies—a case of inadvertent ageism?, 23 j. aging stud. 69 (2009). indiana health law review [vol. 21:311 330 as this, “membership in either group suggests depleted capability, decreased social contribution, significant fragility, and heightened susceptibility to maltreatment by other people.”59 they are sometimes set in a civil-human right perspective, some with a social-model influence, addressing the common social challenges of stigma, inequalities and discrimination that are common in different areas such as participation in the workforce or independent living. 60 alternatively, the common features can be set in a demographic context such as the growing rate of older adults or people with disabilities in the population. 61 and they can be set in a legal context comparing both groups as protected categories 62 that share the ambivalence of the law toward them as vulnerable categories that do not reach the “discrete and insular” minority title that race and sex have been acknowledged. 63 in addition to comparing both categories, many of the articles address their potential for intersectionality. one of the articles interestingly emphasizes the conflation of both categories since historically people were regarded as old when their abilities decreased to a level of disability. 64 but even today when there are definitions that draw a distinct line between both categories, more and more people cross over these lines. many of the seventeen articles address the growing numbers of older people with acquired disabilities 65 stating that “arguably every person will be disabled if they live long enough”. 66 only one article addresses the intersection of age and disability from the other direction— not only are older people acquiring more disabilities but more people with disabilities are living longer hence reaching older age. 67 there is an understanding that as more and more people belong to both groups, the difference in attitudes, theories and policies bring many people into conflict with themselves.68 therefore, there is a need for a more holistic approach and bridging efforts between both categories acknowledging the conceptual benefits ————————————————————————————— 59. francis & silvers, supra note 55, at 140. 60. myhill & blanck, supra note 53, at 47. 61. id. at 56. it is interesting to see how the ‘tsunami’ metaphor common in gerontology (‘the gray tsunami’) is infiltrating into disabilities’ discourse mostly regarding autism. see, e.g., mark blaxill et al., autism tsunami: the impact of rising prevalence on the societal cost of autism in the united states, 52 j. autism & developmental disorders 2627 (2022). 62. for example, the age discrimination in employment act compared to the americans with disabilities act of 1990. 63. francis & silvers, supra note 55, at 147-48. 64. paul harpur, old age is not just impairment: the crpd and the need for a convention on older persons, 37 u. pa. j. int’l l. 1027, 1043 (2015). 65. myhill & blanck, supra note 53, at 56; see also kevin m. cremin, regarding age as a disability: conceptualizing age discrimination at work as (mis) perception of disability discrimination, 39 cardozo l. rev. 439, 447 (2017); phyllis talley, the elderly disabled: the applicability of disability rights for age-related disability, 40 j. legal med. 115, 121 (2020). 66. harpur, supra note 64, at 1043. 67. they are sometimes addressed as the first generation of individuals aging with disabilities. see myhill & blanck, supra note 53, at 56. 68. francis & silvers, supra note 55, at 141. 2024] old-age-based and disability-focused 331 of mutual learning. in the next sections we will focus on three comparative perspectives in these articles: analysis of the relationships between disability law and elder law; common human rights challenges; and finally, the effect of the crpd on current efforts to protect older persons’ rights in international law. c. the relationships between elder law and disability law the relationship between elder law and disability law, as reflected in these articles, can be reduced to five elements: disability and old age are both similar and different in many aspects. this unique combination leads to a tension between both worlds in their legal context. the tension is approached by two opposite strategies: separation efforts and bridging efforts. the discussion in this chapter is based on the seventeen articles that were at the heart of the qualitative research and, when necessary, with a few references to additional articles. 1. similarity as already stated in chapter i, there is a considerable overlap between elder law and disability law due to many common challenges and social obstacles. this overlap is addressed throughout the focus articles in several ways. for example, both fields deal with similar issues such as legal capacity, housing, and employment. both are tied, sometimes wrongly, to vulnerability and diminished capacities. both suffer from a similar perception as ‘warm but incompetent’ leading to a paternalistic prejudice against them. 69 but the main similarity that was addressed in the focus articles is that both old age and disability are labels and categories that can be used to trigger legal overprotection and to promote human rights. 70 this raises one of the leading dilemmas of both disability and old age discourse: is the gain of their unique label worth the pain? this is also addressed as the law’s ambivalence toward disability and old age as to when they matter and when are they irrelevant in shaping policies and social attitudes. for example, age and disability are set apart from race and sex regarding the fourteenth amendment because the age or disability of the person is seen to be a relevant and legitimate question. 71 both disability and old age share the tension between stereotypical generalizations used to justify discrimination versus relevant characterizations that are the basis for benefits (pensions, discounts), special services (assisted living) and rights ————————————————————————————— 69. cremin, supra note 65, at 450-51. 70. helene love, ageism, language and the law, 31 windsor rev. legal & soc. 133, 141 (june 8, 2011). 71. francis & silvers, supra note 55, at 148. indiana health law review [vol. 21:311 332 (accommodations). 72 in other words, they share the “difference dilemma:”73 is equality best achieved by treating people with disabilities and older people the same as others or by treating them differently? 74 one of the main questions lying underneath many of the discussions in the articles is when does specialism perpetuate the marginalization of both groups and when does it help shed a light on their disempowerment and need for affirmative action? another important similarity is the mutual focus on the structural factors that lead to inequality and rejection of the idea that individual differences and deficits explain and justify discriminatory practice. disability legal scholars often reject the medical model and refer to the social model and to human rights as a basis for reframing and interpreting the legal aspects of disabilities. 75 the interactive model that acknowledges the equally important roles of the person’s state and the environment’s design is usually at the core of these articles. 76 age scholars as well have emphasized the structural approaches that lead to oppression, poverty, and marginalization of older persons. 77 finally, older persons and people with disabilities share a common history of neglect under international law for many years. this similarity has dramatically changed since the adoption of the crpd, as will be elaborated later in this chapter. 78 2. difference the similarities described above, do not cover all grounds. there are different historical and social background to ageism and ableism. ableism is driven by a unique history of segregation, medicalization, and eugenics. ageism, on the other hand, derives from a combination of power and disempowerment that characterize the economic status, social power, and position of older persons in society. ableism and ageism describe different social problems and fighting them means using a different set of tools. 79 one example of the difference between both worlds is the rejection of the medical and individual model within disability studies. this leads to critique of the health and welfare professionals, who are viewed with suspicion for being paternalistic, arbitrary, and oppressive. a notion that is not as dominant in elder ————————————————————————————— 72. id. at 149. 73. martha minow, learning to live with the dilemma of difference: bilingual and special education, 48 l. & contemp. prob. 157 (1985). 74. westwood, supra note 32, at 508. 75. jerome e. bickenbach et al., models of disablement, universalism and the international classification of impairments, disabilities and handicaps, 48 soc. sci. & med. 1173 (1999). 76. matilde leonardi et al., the definition of disability: what is in a name? 368 lancet 1219 (oct. 7, 2006). 77. harpur, supra note 64, at 1047-56. 78. kanter, supra note 42, at 539. 79. harpur, supra note 64, at 1058. 2024] old-age-based and disability-focused 333 law. 80 another difference is the scholar’s perception of legal change and reform. a good example is the efforts to apply lessons learned from the olmstead decision addressing institutionalization and the right to receive services in the most integrated setting, to the legal capacity field. two of the articles that focus on legal capacity for older adults, learn from olmstead the need for safeguards in guardianship and the role of public guardians in promoting community living:81 olmstead serves as a charge to states, if not a duty, to address unmet needs in the area of public guardianship.82 these articles do not say a word about eliminating guardianship and do not call for a paradigm shift. this thread of thought is almost outrageous in the disability rights movement. 83 in the disability rights discourse, olmstead is a call for elimination of exclusion and isolation of people with disabilities. guardianship is exactly these things, since it “creates a legal construct that parallels the isolation of institutional confinement.”84 therefore, guardianship is a form of disability-based discrimination. it needs not improvement but replacement, and a shift from substitute decision making to supported decision making. 85 this is one example of the different mindsets of disability and oldage legal scholars. its outcomes will be followingly discussed. interestingly enough, none of the articles learned from olmstead about de-institutionalization of nursing homes. this example might imply a more dramatic difference between disability law and elder law. disability law scholars turn to critical thinking hence to a radical demand for full human rights realization and opposition to segregationbased arrangements. whereas elder law scholars have a more moderate perspective which emphasizes the spectrum of solutions and interventions and even a discomfort from all-or-nothing approaches. ————————————————————————————— 80. theodorou, supra note 54, at 985. however, one can find some criticism over professionals’ paternalistic approach toward older persons, for example, in elder law writings in the field of elder-guardianship. see israel doron, aging in the shadow of the law: the case of elder guardianship in israel, 16 j. aging & soc. policy 59 (2004) . 81. see eleanor cashmore, guarding the golden years: how public guardianship for elders can help states meet the mandates of olmstead, 55 b.c. l. rev. 1217 (2014). 82. hailey m. hanners, who wants the ward: the state’s role in adult guardianship proceedings, 11 est. plan. & cmty. prop. l. j. 359, 371 (2018). 83. robert dinerstein, esme grant grewal & jonathan martinis, emerging international trends and practice in guardianship law for people with disabilities, 22 ilsa j. int’l & comp. l. 435 (2015); arlene s. kanter & yotam tolub, the fight for personhood, legal capacity, and equal recognition under law for people with disabilities in israel and beyond, 39 cardozo l. rev. 557 (2017). 84. leslie salzman, rethinking guardianship (again): substituted decision making as a violation of the integration mandate of title ii of the americans with disabilities act, 81 u. colo. l. rev. 157, 194 (2010). 85. claudia martin et al., the human rights of older persons in the european institutions: law and policy, in 45 human rights of older people: universal and regional legal perspectives 125, 135 (2015). indiana health law review [vol. 21:311 334 3. tension the similarities and differences described above create a complex intertwined relationship between the assumptions at the base of the disability movement and those at the base of the older rights movement. ageism is the attribution of a deficit in abilities based upon age. therefore, one of the main strategies used by age scholars to fight ageism is to disentangle age from disability. whereas one of the main strategies used in disability discourse is to describe disability as a ‘difference’ that reflects the range of human experience. 86 this leads to an inherent tension between one movement’s renunciation of the other movement’s main characteristic. without explicitly saying so, the fight against ageism can easily turn to ableism. 87 this ambivalence can be seen also in love’s paper on the term ‘elderly’. love turns to feminist and disability critical writing that emphasizes the importance of language in perpetuating or revealing stereotypes and oppression. but her next step is to reject the use of the word ‘elderly’ (as opposed to older adults) because it implies frailty, disability, and senility. older adults, according to love, choose not to associate with the term ‘elderly’ because of its negative connotation of disability, care, vulnerability, and neediness. 88 again disability is seen as a negative stigma that is wrongly tied to old age. the tension hereby described, can explain a tendency that is shared by disability and older age legal scholars, to step away one from the other, as described in the next part. 4. separation there are many levels of efforts in the focus articles, to mark the difference between disability and old age. these efforts are described as the tendency of the people themselves, but they are explained, understood, and even supported by scholars. for example, many older people tend to alienate themselves from a disability label and even more from a disability identity, attributing their disabilities to normative aging to alienate themselves from the stigma that comes along with a disability label. 89 this shoving away also happens when there are clear advantages under the disability label; for example, the remedies of employment discrimination under the ada or access to disability benefits. for many people, the disability-label’s ‘cost’ outweighs its benefits. 90 the disability-label brings along stigma, a declaration of incompetence, and calls for protective and limiting measures. older people are in no hurry to embrace these ————————————————————————————— 86. myhill & blanck, supra note 53, at 55. 87. harpur, supra note 64, at 1047-56. 88. love, supra note 70, at 146, 153. 89. cremin, supra note 65, at 450-51. 90. id, at 475-79; talley, supra note 65, at 125. 2024] old-age-based and disability-focused 335 limitations.91 there are other separative efforts for more practical reasons. for example, revealing the unique manifestations of ageism that are not protected under antidisability-discrimination policy. harpur lists several examples of ageist attitudes that are not related to disability: a mandatory retirement age, conceptualizing old age as a demographic hazard, and discrimination based on the appearance as old. 92 this is part of a broader effort to define a distinct line between disability and older persons’ rights. a different way to differentiate disability and older persons’ rights is to relocate all the issues derived from ‘physical or mental infirmities’ to the disability world. in other words, some scholars claim that legal capacity or supported housing should be conceptualized through a disability’s lens as opposed to age. 93 a similar but more nuanced approach is to distinguish between different kinds of disabilities. for example, hacker distinguishes between agerelated disability (e.g. geriatric hospitalization) and other kinds of disabilities 94 while kaya distinguishes ‘atypical impairments’ covered by the disability rights umbrella and ‘age-based impairments or weaknesses’ that are typical and therefore ignored by the disability community. 95 to summarize, we can see that scholars are busy differentiating between disability and older person’s rights. 5. bridging along these separationist efforts we can also see an attempt to develop bridging strategies. the rising number of people with acquired disabilities in mid and later life enhances the need to develop successful aging practices from a disability perspective. the rising number of people with disabilities reaching old age requires a deeper understanding and acknowledgment of gerontology in the disability community. the two worlds cannot stay apart. 96 an interesting example of the potential cooperation between disability and older persons’ rights is manifested in theodorou’s explanation to texas’ pioneering 2015 legislation on supported decision-making.97 texas is a conservative state, suspicious of international law, and yet it is the first state in the us to legislate a crpd inspired law. thodorou’s explanation is that two combined forces came into play—a disability rights movement that, according to thodorou, was an effective stakeholder, and concern from the ‘gray tsunami’ and its implications on the public guardian system. theodorou illustrates how ————————————————————————————— 91. talley, supra note 65, at 125-28. 92. harpur, supra note 64, at 1052-54. 93. westwood, supra note 32, at 507. 94. see generally hacker, supra note 29 (this article, which was not included in the focus articles, includes interesting opening remarks regarding the distinction between disability law and elder law). 95. refia kaya, reasonable accommodation for age, 33 can. j. law soc. 115, 129 (2020). 96. myhill & blanck, supra note 53, at 59. 97. theodorou, supra note 54. indiana health law review [vol. 21:311 336 disability and age interplay and affect each other in unexpected ways, one bringing ideology and the other the urgent need for reform. to summarize this section, the differences and similarities between both worlds lead to interesting and sometimes conflicting efforts to create a dialogue between disability and older persons’ rights. in the next chapter we will dive into several common human rights issues addressed in the focus articles to see this complex relationship in action. d. common human rights challenges there are many shared human rights challenges for people with disabilities and older persons. in this chapter we will address three main examples described in the articles and analyze the similarities and differences in how these challenges are approached by each discipline. 1. legal capacity as described earlier, legal capacity is one of the leading subjects in the quantitative analysis. there is shared concern regarding peoples’ capacity, the flaws of guardianship, and the need for change. 98 the crpd is also a powerful force to promote change based on article 12’s standards. however, the emancipative arguments against guardianship from the disability standpoint turns to a more moderate note, hesitant or cautious, in the articles concerning older persons’ rights: although there is growing societal acknowledgment of the importance of respecting individual choice, guardianship is still widely accepted as a necessary mechanism for the protection of vulnerable adults. 99 respectively, the focus of legal capacity in these articles focused on older persons is improving guardianship, recognizing new mechanisms such as supported decision making and pushing forward safeguards. one interesting effort that is described in several articles is redefining the guardian’s role as an advocate for human rights. for example, fighting for the right of their wards for independent living with community-based services instead of institutionalization.100 2. independent living and de-institutionalization the independent living movement that arose in the 1960s in the disability community had a major effect on developing both person-centered services and ————————————————————————————— 98. martin et al., supra note 85, at 134-39. 99. cashmore, supra note 81, at 1220. 100. id. at 1235-37; hanners, supra note 82, at 370-71. 2024] old-age-based and disability-focused 337 home and community-based services (hcbs). personal care assistance (pca) is prominent today for people with disabilities and older persons who need inhome assistance and enables an alternative to institution-based care. 101 there is a vibrant discussion regarding the different aspects of pca that need to be rethought, such as recognizing and paying for family caregiving, self-directed programs, and giving out money versus service providing. however, there is an important difference between disability and older persons when it comes to segregated living. ‘senior living’ communities are common in the united states and are seen as a legitimate response for older persons. this trend affects and weakens the right to independent living of older persons in many ways. the communities are isolated, transportation is mostly private, choices are more likely to be limited in a gated neighborhood, and they set a distance between older adults and their families and communities. moreover, the rising alternative of senior living communities has a negative impact on the development of services, support, and accommodations that enable older persons to age in their communities. 102 although one can find articles, mostly non-legal writing, legitimizing ‘intentional communities’ for people with disabilities 103 , the leading line especially in policy papers is to oppose these solutions and to describe them as new versions of the same old and problematic institutional regime 104 . 3. employment the main issue discussed regarding employment in the focus articles, is the right for accommodation. both adea and ada protect from discrimination on age and disability grounds respectively. ada covers employers of fifteen or more people while the adea covers only employers of twenty or more. but the main difference between both groups is the right to accommodation. an employer is obligated to provide reasonable accommodations due to disability. failure to do so constitutes discrimination. this is a clear disadvantage for older persons who do not enjoy this right. two of the articles in this research address this difference. one investigates why older people with disabilities do not make more use of the ada measures. 105 the other tries to develop a separate clause for reasonable accommodation based on age. 106 this is a good example of how disability sets forward a new legal mechanism that can eventually influence the ————————————————————————————— 101. bridget haeg, the future of caring for elders in their homes: an alternative to nursing homes, 9 naela j. 237, 238-41 (2013). 102. francis & silvers, supra note 55, at 150-57. 103. louise meijering et al., intentional communities in rural spaces, 98 tijdschrift voor economische en sociale geografie 42 (2007). 104. national council on disability, home and community-based services: creating systems for success at home, at work and in the community 36-40 (2015) https://ncd.gov/publications/2015/02242015 [https://perma.cc/g33r-6ld9]. 105. cremin, supra note 65 106. kaya, supra note 95, at 9. https://perma.cc/g33r-6ld9 indiana health law review [vol. 21:311 338 rights of older people. finally, there are many issues mentioned in the articles that provoke a comparison between disability and older persons’ rights. in the u.s, anti-hate crime legislation includes people with disabilities and excludes older persons, 107 protection against exclusion in public places and receiving public services is given to people with disabilities and absent in older persons’ legislation, the fair housing act protects people with disabilities against discrimination without including older persons. 108 one can see a returning pattern: people with disabilities enjoy greater protection by law. in our discussion we will ask how this difference shapes the relationship between disability and elder law. e. international law instruments – the crpd and older persons’ rights four of the articles included in this research focus on international law and crpd’s influence on the promotion of older persons’ human rights. the discussion includes two questions: is there a need for a special convention on the rights of older persons and how are older persons affected by the crpd? one of the main arguments against promoting a separate human rights convention for older persons, mentioned in these articles, is that they are already protected under existing international human rights law—in general, and by crpd—specifically, hence there are no normative gaps that need to be dealt with. the articles also mention the position that fragmentation of human rights poses danger to the idea of universal rights and therefore we should avoid them. 109 the strongest answer to this argument comes from a comparison to people with disabilities. both people with disabilities and older persons have not received adequate protection in international law through the universal mechanisms (i.e. the universal declaration of human rights). 110 just as people with disabilities experience unique social conditions that need to be addressed separately, so do older persons. finally, just as people with disabilities have benefited in many ways from the crpd, so will older people benefit from their own un convention. 111 one example of the need for a separate treaty is given in an analysis of the scarce reference to older persons in human rights reports. for example, out of 124 state reports under the iccpr from 2000–2008, only three made a reference to older persons. 112 the crpd has the potential to influence the rights of older persons by highlighting the gaps in the current international elder law field. it calls for a shift from a focus on treatment and protection to a human rights-based approach. this includes not only addressing issues like guardianship, social security, and ————————————————————————————— 107. francis & silvers, supra note 55, at 141. 108. id. at 149. 109. frédéric mégret, the human rights of older persons: a growing challenge, 11 hum. rts. l. rev. 37, 41 (2011). 110. kanter, supra note 42 at 549. 111. harpur, supra note 64, at 1036. 112. mégret, supra note 109, at 50. 2024] old-age-based and disability-focused 339 medical care but also recognizing the right to work, independent living, access, autonomy, and even a general human right to age. the crpd stands out as a treaty that encompasses both human, civil, and political rights, as well as social, economic, and cultural rights. 113 in conclusion, the crpd’s participatory process, inclusive language, comprehensive human rights framework, and effective legal enforcement mechanisms can serve as a model for developing a specific un treaty addressing the rights of older persons. 114 the second question raised in the articles is in what ways are older persons included and excluded from the crpd? first, older persons are included in the crpd since many of them meet the definition of disability. two articles in the crpd 115 specifically protect older persons with disabilities 116 and the others cover the most fundamental rights of any person with disability, including older persons with disabilities, such as the right to health, liberty, access to justice, mobility, privacy, legal capacity, independent living and more. 117 furthermore, the crpd has an indirect influence on older persons by promoting new standards for their rights. for instance, the recommendation on promotion of human rights of older persons, adopted by the committee of ministers of the council of europe in 2014, is directly influenced by article 12 of the crpd, which highlights supported decision-making as a best practice. 118 this demonstrates how the crpd extends its impact beyond disability rights to shape the discourse on the rights of older persons. however, protection against ageism is not directly related to disability and therefore is not protected under the crpd. unlike women and children, older persons with disabilities are not specifically addressed in dedicated articles within the crpd. additionally, there are issues that are specifically relevant to older individuals, such as retirement, and challenges that are relevant to disability but manifest uniquely in old age, including the right to life in the context of euthanasia, the right to family life in relation to nursing homes and hospitalization, and the right to legal capacity in cases of dementia. 119 these gaps in coverage underscore the necessity for a distinct treaty dedicated to upholding the human rights of older persons. in summary, the crpd stands out as a prominent illustration of both direct and indirect influence from the disability sphere on older persons, serving as a significant normative framework that encompasses older persons with disabilities and as a reference for the possible advancement of older persons’ rights in the realm of international law. ————————————————————————————— 113. kanter, supra note 42, at 572. 114. id. at 571. 115. g.a. res. 61/106, at art. 25 (dec. 12, 2006); see also id. at art. 25. 116. harpur, supra note 64, at 1044-47. 117. harpur, paul, embracing the new disability rights paradigm: the importance of the convention on the rights of persons with disabilities, 27 disability & soc’y 1 (2012). 118. martin et al., supra note 85, at 136-38. 119. mégret, supra note 109, at 49-63. indiana health law review [vol. 21:311 340 v. discussion in this final chapter we wish to integrate the quantitative and qualitative parts and incorporate them into a broader context rooted in elder law and disability law. in the first part we will discuss the characteristics of the articles in this research. in the second part we will draw a wider picture of the relationship between elder law and disability law that can be drawn from this research. a. literature characteristics there a several distinct attributes that can be observed in the reviewed literature. firstly, it is predominantly centered on the american context, emphasizing its specific legal framework. secondly, the literature exhibits a non-empirical approach, primarily analyzing the existing legal situation from a normative perspective. thirdly, when conducting direct comparative analysis, the articles are primarily focused on issues related to old age, thus the ‘old age based and disability focus’ theme. finally, there is an interesting pattern regarding the three core issues of independent living, personhood and protection. we will address each one of these characteristics separately. 1. american-based this research is primarily based on english literature, which limits its representation of the extensive international discussions taking place in the fields of elder law and disability law. nevertheless, it is important to acknowledge that both disciplines have a significant foundation rooted in the american legal context. both academic disciplines, elder law and disability law, have emerged and are primarily rooted in the american legal literature. the reasons behind this association are distinct for each field yet also share commonalities. elder law literature, in particular, has traditionally been more extensively developed in north america, 120 with a significant emphasis on the civil rights framework and sociolegal theory. its origins can be traced back to the 1980s when the aging population in america led to the recognition of a distinct and unique field of study. consequently, references and contributions to elder law from outside the united states were scarce until the 2000s. however, over the past two decades, there has been a notable shift, with an increasing interest in this field from other countries and the emergence of transnational comparative elder law studies, as well as international developments in elder law. despite this growing international interest, it remains evident that u.s. academic writings continue to hold a central position in shaping the discourse ————————————————————————————— 120. helen meenan, age discrimination and the future development of elder rights in the european union: walking side by side or hand in hand?, in beyond elder law: new directions in law and aging 57 (israel doron et al. eds. 2012). 2024] old-age-based and disability-focused 341 surrounding elder law. 121 since the implementation of the americans with disabilities act (ada) in 1990, disability law scholarship has predominantly thrived in the united states, significantly influencing the anti-discrimination perspective within the field. 122 in the wake of the ada, numerous countries enacted their own disability rights legislation, leading to the development of localized disability jurisprudence that bore the unmistakable imprint of american influence. this influence is particularly noteworthy in english-speaking countries like england, canada, and australia. additionally, the widespread adoption of the convention on the rights of persons with disabilities (crpd) by many countries played a pivotal role in fostering international and comparative interest in disability law. 123 nevertheless, disability legal theory, often referred to as disability legal studies (dls), remains predominantly grounded in sociolegal and critical legal theories originating from the united states. these theories scrutinize the role of law in perpetuating and reinforcing social hierarchies, drawing inspiration from critical legal studies, feminist and queer legal theory, and critical race theory.124 consequently, it is evident that both elder law and disability law have flourished in the united states due to the distinctive characteristics of american legal scholarship and its tradition of civil rights advocacy. this contextual backdrop may account for the predominance of united states-based academic research that compares the rights of older individuals and individuals with disabilities. 2. normative-based traditionally elder law and disability law are normative in their methodology i.e., they are based on textual analysis and founded on moral, value-based, or ideological argumentation on how law should address old-age or disability issues. 125 therefore, it is not surprising that there were very few empiricist articles (2 of 180) in our research. although empirical legal studies have become central in legal publications and the number of empirical-based works published have skyrocketed over the decades, 126 this is not the case in this literature review. ————————————————————————————— 121. doron, supra note 26 at 3. 122. bagenstos, supra note 13; david a. weisbach, toward a new approach to disability law, 2009 u. chi. legal f. 47 (2009). 123. andrea broderick & delia ferri, international and european disability law and policy 30 (2019); michael l. perlin, a change is gonna come: the implications of the united nations convention on the rights of persons with disabilities for the domestic practice of constitutional mental disability law, 29 n. ill. ul rev. 483 (2008); kanter, supra note 12, at 471. 124. mor, supra note 19, at 68. 125. this is a wider tradition of legal research. see sanne taekema, theoretical and normative frameworks for legal research: putting theory into practice, l. & method (2018). 126. daniel e. ho & larry kramer, introduction: the empirical revolution in law, 65 stan. l. rev. 1195 (2013). indiana health law review [vol. 21:311 342 elder law started out with very little empirical-quantitatively based research in the field, 127 and empirical information describing the field is scarce. 128 this has changed in the last decades and there is a call from within legal scholarship for more els oriented research. 129 disability law was also established from a non-empiricist perspective. the theoretical thickness of disability studies has influenced disability law research to focus on the application of the human rights model and the social model in the legal context of disability. the sociological roots of disability law have also affected the nature of the research focusing on the social construction of disability, a more conceptual than empirical perspective. 130 throughout the years there is a rise in empirical research in disability law and elder law. disability law researchers have analyzed court decisions to reveal law in action 131 , conducted surveys and in-depth interviews to understand the perspectives of people with disabilities and their surroundings 132 , and mined data to find a correlation between disability policy and the actual lives of people with disabilities. 133 old age law scholars have analyzed legal texts such as wills, court decisions, and lasting powers of attorney to reveal their hidden agendas, 134 conducted in-depth interviews with older persons, policy makers and others to help shape the next steps in legislation, 135 and used empirical methods to describe the evolving field of elder law (courses taught, areas litigated and attitudes toward the field). 136 the low rate of empirical research in this study cannot be attributed solely to the nature of disability and elder law. consequently, we explore four possible explanations for the lack of an empirical approach in our literature. first, as previously mentioned, legal ————————————————————————————— 127. doron, supra note 26, at 14; israel doron & itai apter, international rights of older persons: what difference would a new convention make to the lives of older people? 11 marq. elder’s advisor 367, 368 (2009). 128. nina a. kohn & edward d. spurgeon, elder law teaching and scholarship: an empirical analysis of an evolving field, 59 j. leg. educ. 414 (2010); 129. doron, supra note 26, at 7-8, 14. 130. katharina heyer & sagit mor, guest editors’ introduction: disability legal studies, 53 l. & soc’y rev. 948 (2019). 131. sagit mor & rina b. pikkel, disability, rights, and the construction of sexuality in tort claims, 53 l. & soc’y rev. 1016 (2019); robyn m. et al., the americans with disabilities act and termination of parental rights cases: an examination of appellate decisions involving disabled mothers, 39 yale l. & pol’y rev. 157 (2020). 132. doron dorfman, (un)usual suspects: deservingness, scarcity, and disability rights, 10 uc irvine l. rev. 557 (2020). 133. david freeman engstrom & david k. hausman, rights, redistribution, and the rise of the “litigation state”: the case of disability discrimination laws, 46 l. & soc. inquiry 788 (2021); christopher l. griffin, jr., explaining ada employment discrimination charges over the business cycle, 84 u. cin. l. rev. 737 (2016). 134. shiri regev-messalem, how the law “keeps the money in the family”: lessons at the intersection of elder care and inheritance disputes in israel, 45 l. & soc. inquiry, 1 (2019). 135. nina a. kohn et. al, identifying connections between elder law and gerontology: implications for teaching, research, and practice, 25 elder l.j. 69 (2017). 136. spanier et al. supra note 46; israel doron, older europeans and the european court of justice, 42 age & ageing, 604 (2013); kohn & spurgeon, supra note 128. 2024] old-age-based and disability-focused 343 research tends to be primarily normative in nature. second, the scarcity of data regarding individuals with disabilities and older persons poses a challenge to understanding legal policies, attributable to privacy concerns and a lack of effort in collecting relevant data by the authorities. when available, the data often relies heavily on statistical analysis and is infused with ageist or ableist assumptions, such as the medical definition of disability. 137 third, this literature review concentrates on the emerging comparative field of age and disability. given its nascent stage, the focus naturally gravitates toward thematic and normative comparisons, encompassing legislation, societal barriers, and ideologies. although empirical research and normative research are parallel and stand in tension and relation, 138 empirical research often emerges once common theoretical foundations are established, and a clearer understanding of the areas requiring investigation and comparison is attained. 139 lastly, empirical studies tend to incur higher costs, which may influence researchers in doctrinal-focused fields to lean toward non-empirical endeavors. 3. old-age-based and disability-focused perhaps the most noteworthy observation derived from this research is the prevailing nature of the existing literature on disability and aging, which we refer to as “old-age-based and disability-focused.” in other words, it primarily explores what older individuals and old-age policies can learn and benefit from disability policies. this conclusion is substantiated by two key findings. first, 82% of the articles analyzed in the qualitative research approach the subject from an oldage perspective, focusing predominantly on older persons. only one article adopts a disability perspective to investigate aging policies in relation to disability. 140 second, in the quantitative research, when examining articles that address intersectional identity (n=34), with the exception of two, all of them center on the concept of aging into disability, particularly in the context of dementia. the second finding can be attributed to the historical integration of ————————————————————————————— 137. andrea rosales & mireia fernández-ardèvol, structural ageism in big data approaches, 40 nordicom rev. 51 (2019); cynthia bruce, unsettling ableism in research traditions: toward establishing blind methodologies, in social research and disability: developing inclusive research spaces for disabled researchers 127 (ciaran burke & bronagh byrne eds. 1st ed. 2020). 138. theresia anita christiani, normative and empirical research methods: their usefulness and relevance in the study of law as an object, glob. j. of bus. & soc. sci. 16 (2015); carlo leget et. al, ‘nobody tosses a dwarf!’ the relation between the empirical and the normative reexamined, 23 bioethics 226 (2009). 139. see taekema, supra note 124, at 10-11 (“it is not fully social scientific, because it does not usually aim at empirical data collection or at answering explanatory questions. in its own way, it does gather facts, but then one needs to understand fact-gathering more broadly than as empirical data collection.”). 140. myhill & blanck, supra note 53. two other articles come from a thematic point of view and do not have a population focus. indiana health law review [vol. 21:311 344 aging into disability discourse, while the exploration of aging with disability is a relatively emerging and understudied area, particularly beyond the realm of medicine. 141 however, the first finding suggests an imbalance in the relationship between disability and older individuals within legal studies. it raises the question of why scholars specializing in elder law demonstrate interest in disability law, while the opposite perspective seems to be lacking. while various explanations exist, the issue at hand remains unexplored, thus underscoring the novelty of our argument. one potential reason could be attributed to the remarkable progress made within the disability field, which has positioned itself as a paradigm for other groups to follow. alternatively, some may emphasize the well-established nature of elder law as a field that is receptive to drawing lessons from its surroundings. 142 we want to suggest that the one-directional observed in this research can be key to gaining a better understanding of the two-directional relationship and intersection between elder law and disability. 4. core issues as described above, there are three core issues that are discussed in the literature: personhood, independent living, and protection. however, when analyzing the core issues by main target-population we can clearly see a difference between disability-focused and old-age-focused literature. disability-focused research is mostly interested in personhood and independent living and less in protective measures. in contrast, older persons’ literature is much less interested in personhood and more interested in protection. among the comparative articles, none has focused on protection. why is protection absent from the articles included in the qualitative research? according to bagenstos, the disability rights movement in america primarily prioritized two key objectives. first, there is a negative goal of attaining freedom from the control and paternalism of others, emphasizing autonomy. second, there is a positive aim of complete integration into society. 143 for many activists within the disability rights movement, protective measures such as guardianship, forced treatment, and out-of-home placement are considered part of the problem rather than a solution. consequently, disability-focused literature is less inclined to address protective measures as a goal, instead choosing to concentrate on concepts such as personhood, independent living, and the provision of access accommodations and support as ————————————————————————————— 141. michelle putnam, extending the promise of the older americans act to persons aging with long-term disability, 39 rsch. on aging 799, 799 (2017). 142. kohn & spurgeon, supra note 128. 143. see samuel r. bagenstos, law and the contradictions of the disability rights movement 76 (2009) (claiming that these two objectives are limited and therefore we need to move beyond anti-discrimination and accommodation toward a new definition of a tailored social welfare). 2024] old-age-based and disability-focused 345 a means to achieve these objectives. 144 this is also the reason why the focus articles, old-age-based and disability-focused, do not include protection as a core issue. the perspective of elder law on protection differs from that of disability law. doron’s multi-dimensional model of elder law highlights the significance of the protective dimension in addressing issues of abuse and neglect. 145 the negative perception of protective measures within disability scholarship might explain why scholars in elder law tend to avoid making comparisons. instead, they focus on shared areas of learning and enrichment, such as personhood and independent living. in summary, the issue of protection emerges as a distinguishing factor when comparing elder law and disability law, influencing discussions related to personhood and independent living. if protection is considered a priority, guardianship and institutionalized settings may be viewed as legitimate solutions for older individuals. however, where protection is viewed more as a double-edged sword, the disability law community tends to adopt a more critical all-or-nothing stance toward guardianship and institutionalization. b. the relationship between disability law and elder law in this final chapter we wish to take a step forward and propose a connection between the findings of our research and the relationship between disability law and elder law. there exists a tension between these two, and while this tension is not explicit in the reviewed literature, it is present in numerous subtle ways. in the following section, we will explore the various manifestations of this tension. 1. manifestation of ableism in elder law and ageism in disability law when investigating the complex realm of discrimination and stigma between two marginalized groups and two critical legal domains, one must exercise caution. in the subsequent section, our aim is to present potential manifestations of ageism and ableism in the approaches adopted by elder law and disability law. these manifestations are not explicit in the focus articles. 146 we therefore turn to broader legal and non-legal literature to propose an explanation for our principal finding, which highlights the “old-age-based and disability-focused” nature of the qualitative analysis. ————————————————————————————— 144. robert perske, the dignity of risk and the mr, 10 mental retardation 24 (1972) (first coining the term ‘dignity of risk’ as a human right; it is one of the ways scholars address risk and protective measures in disability); for a literature review on the subject, see pauline marsh & lisa kelly, dignity of risk in the community: a review of and reflections on the literature, 20 health, risk & soc. 297 (2018). 145. doron, supra note 28, at 61. 146. see jönson & larsson, supra note 58 (the one exception, addressing ageism in disability activism). indiana health law review [vol. 21:311 346 first, we will acknowledge the common attributes between ageism and ableism. recognizing the parallels between these forms of discrimination is a crucial stride toward comprehending their intersections, divergences, and occasional collision. afterward, we will address the tension between both fields, which can lead to mutual stigma and discriminatory attitudes. we will start with the shared grounds of both fields. both disability and old age are socially constructed categories. both ageism and ableism are groupbased discriminations that share many assumptions on frailty and vulnerability, 147 and both are based on a social constructionist approach to old age and disability. 148 moreover ageism and ableism frequently go hand-in-hand, positioning older persons and people with disabilities on the same discriminated side. the covid-19 pandemic serves as a most recent example, where we saw how older persons and people with disabilities were excluded in protocols from lifesaving treatments, 149 were being called to sacrifice themselves for the sake of the economy, 150 were isolated in long-term care institutions and suffered higher rates of mortality in those institutions. 151 as one article title said, covid19 was not only a virus spread. ageism and ableism were diffused as well. 152 finally, both disability and old age policy and anti-discrimination efforts refer to communities with loose boundaries. there is a potential wide entrance door to these categories. this looseness can explain the efforts to define who is a person with disability and who is a person of old age; when the borders are vague, they become an essential part of the discussion. 153 responses to this question may vary depending on the context, but the question itself serves as a compelling and distinctive characterization of both groups. in a playground where boundaries hold significance, the convergence of age and disability introduces complexity and fluidity. how do we categorize a sixty-five-year-old individual with parkinson’s disease? where do we place a fifty-year-old person with intellectual disability and memory loss? does the differentiation between a seventy-five-year-old individual who has been blind since birth and a seventy————————————————————————————— 147. carla branco et al., the association of group‐based discrimination with health and well‐being: a comparison of ableism with other “isms”, 75 j. soc. issues 814 (2019). 148. overall, supra note 43, at 129 149. samuel r. bagenstos, who gets the ventilator? disability discrimination in covid19 medical-rationing protocols, 130 yale l.j. f. 1 (2020); leniza de castro-hamoy & leonardo d. de castro, age matters but it should not be used to discriminate against the elderly in allocating scarce resources in the context of covid-19, 12 asian bioethics rev. 331 (2020). 150. sunder john boopalan, injustices of ableism and ageism during the pandemic: a call for intergenerational solidarity, 22 vision 52 (2021); joel michael reynolds & anna landre, ableism and ageism: insights from disability studies for aging studies, in critical humanities and ageing: forging interdisciplinary dialogues 118 (kate de medeiros, marlene goldman & thomas cole eds., 2022). 151. liat ayalon et al., long-term care settings in the times of covid-19: challenges and future directions, 32 int’l psychogeriatrics 1239 (2020). 152. federica previtali, laura d. allen & maria varlamova, not only virus spread: the diffusion of ageism during the outbreak of covid-19, 32 j. aging & soc. policy 506 (2020). 153. bagenstos, supra note 143, at 34 (discussing the supreme court’s decisions to narrow ada’s definition of disability and the politics of definition in disability). 2024] old-age-based and disability-focused 347 five-year-old individual who has recently acquired blindness hold significance and carry weight? this last emphasis on boundaries is a valuable starting point to discuss the tension between these two fields. in a bifurcated system wherein older individuals and people with disabilities are entitled to distinct rights, benefits, and supports, the act of categorization becomes instrumental in determining the allocation of resources. besides these practical implications, there is a concealed ideological and social bias that subtly influences the process of categorization. who is part of “us” and who is not, who do we want to join “us” and who is unwelcomed? this brings us to the possible manifestations of ableism in elder law and ageism in disability law. despite the shared values, experience, barriers and challenges of both fields there is a tension between ageism and ableism as two competing frameworks of power relations. kelley-moore coined the term ‘the social construction of causality’ to describe the social process of framing disability prior to old age as non-normative and disruptive while perceiving the development of functional limitation in later stages of life as normative. 154 in other words, disability is seen as a relevant category when experienced in early stages of life. as a person grows old, disability is a ‘normal’ part of being old and therefore it is secondary and sometimes completely transparent in old age as a separate category. moreover, the disentanglement of disability and old age is one of the main goals of the ‘successful aging’ project. 155 successful aging emerged in the 1960s as a significant ideal within the field of gerontology, aiming to challenge dominant negative narratives of old age that emphasized decline in old age. it encompasses various multidimensional aspects, including physical health, mental well-being, social engagement, and active participation in meaningful activities. 156 successful aging emphasizes the importance of maintaining functional independence, adaptive coping strategies, and a positive outlook on aging. it recognizes that aging is a diverse and individualized process, influenced by various factors such as genetics, lifestyle choices, and environmental circumstances. 157 however these positive aspects of ‘successful aging’ come with a price tag. the emphasis of health and functionality, absence of disease and disability, and activeness leads to a form of what gibbons named ‘compulsory youthfulness’ i.e. the idea that to be fully human, one must remain youthful and able-bodied. 158 in recent years there have been many critiques that ————————————————————————————— 154. jessica kelley-moore, disability and ageing: the social construction of causality, sage handbook soc. gerontology 96 (dale dannefer & chris phillipson eds., 2010). 155. john w. rowe & robert l. kahn, successful aging, 37 gerontologist 433 (1997). 156. ann bowling, enhancing later life: how older people perceive active ageing?, 12 aging & mental health 293 (2008). 157. sarah lamb et al., successful aging as a contemporary obsession: global perspectives (2017). 158. hailee m. gibbons, compulsory youthfulness: intersections of ableism and ageism in “successful aging” discourses, 12 rev. disability stud. 3 (2016). indiana health law review [vol. 21:311 348 call for a rejection of the ‘successful aging’ model, not only because it is too narrow but also because it is rooted in medical assumptions regarding the good life and therefore associated with understanding disability solely through the medical lenses. consequently, it contributes to the marginalization of older persons with disabilities.159 in berridge & martinson’s words: if we continue to promote models of aging that leverage ableism to combat ageism, we leave people fearful of their own and others’ aging bodies—hardly a liberating scenario for older adults, and especially for older women, who are particularly disadvantaged by successful aging and the medical model of disability. 160 moreover, only a minority (12%) of people older than sixty-five in the us meet rowe and kahn’s definition of successful aging. 161 in other words, ableist assumptions embedded in the concept of successful aging can contribute to ageism toward older persons who do not meet the health and activity standards associated with successful aging. as a result, scholars highlight the intersections and entanglement of ageism with ableism, emphasizing that these two forms of discrimination can reinforce and perpetuate each other. 162 alongside the presence of ableism within elder law, manifestations of ageism can also be observed within disability law. jönson and larsson highlight the presence of ingrained age-related stereotypes within the discourse of disability rights activists aiming to advocate for the inclusion of young individuals with disabilities in activities typically associated with youth. by making comparative references to younger age groups, the focus shifts from the individual’s disability and functional limitations toward their potential and rightful pursuit of a rich and purposeful life. 163 consequently, the entitlements of individuals with disabilities in later stages of life, such as the right to engage in purposeful activities, participate in community life, access accessible environments, and maintain autonomy, are diminished. the comprehension of the tension between ableism and ageism appears to be in its early stages. numerous practical dilemmas arise when grappling with ————————————————————————————— 159. marty martinson & clara berridge, successful aging and its discontents: a systematic review of the social gerontology literature, 55 gerontologist 58 (2015); stephen katz, active and successful aging. lifestyle as a gerontological idea, 44 recherches sociologiques et anthropologiques 33 (2013); jiayin liang & baozhen luo, toward a discourse shift in social gerontology: from successful aging to harmonious aging, 26 j. aging stud. 327 (2012). 160. clara w. berridge & marty martinson, valuing old age without leveraging ableism, 41 generations 83, 89 (2018). 161. sara j. mclaughlin et al., successful aging in the united states: prevalence estimates from a national sample of older adults, 65 j. gerontology series b: psyc. sci. & soc. sci. 216 (2010). 162. mariska van der horst & sarah vickerstaff, is part of ageism actually ableism?, 42 ageing & soc. 1979 (2021). 163. håkan jönson & annika taghizadeh larsson, ableism and ageism, in encyclopedia gerontology & pop. aging 4 (2022). 2024] old-age-based and disability-focused 349 this intricate relationship. for instance, in the attempt to challenge ageist criteria within covid-19 treatment protocols by emphasizing the resilience and wisdom of older individuals, are we inadvertently reinforcing ableist perspectives on human worth and value? 164 when prioritizing younger people with disabilities in de-institutionalization programs, are we supporting ageist assumptions on whose life matters more? the findings in this research strengthen our assumption that ageism and ableism play a role in both disability law and elder law. the tendency of many old-age-focused articles to mark a clear line between older persons and people with disabilities can be understood as ableist or at the least, as an attempt to duck ableist prejudice by others. the fact that disability-focused articles do not turn to elder law can also be explained as an ageist tendency to dismiss the valuable knowledge developed in gerontology and perceive it as irrelevant. however, as later discussed, there are other reasons for this phenomenon, one being the difference in the developments of rights in each realm and their different characteristics. 2. contrasting approaches in elder law and disability law: exploring divergence another plausible explanation for the unbalanced nature of the articles in the qualitative analysis lies not in the mutual biases and stigmas harbored by the fields, but rather in the distinct attributes that characterize each domain. for example, when comparing the legal accomplishments of each field, disability law demonstrates an advantage. in fact, many of the articles in this research described elder law as being one step behind disability law. the articles, mostly old age based, mentioned the many ways in which disability is a better protected category compared to age in employment, discrimination in public places and services, housing, and de-institutional efforts. this is not only in legislation but also in litigation. even twenty years after olmstead, we do not have a landmark ‘olmstead ii’ decision on nursing homes acknowledging the state’s obligation to promote inclusive independent living for older persons. 165 on the international level the crpd has accelerated unprecedent international and cross-national legislative, litigative and academic efforts in disability. the significance of establishing an international un convention on the rights of older persons becomes evident when considering the profound impact of the crpd. this can explain the lack of disability-based articles focused on old age and the interest in disability by elder law. ————————————————————————————— 164. christopher c. colenda et al., covid-19 pandemic and ageism: a call for humanitarian care, 68 j. gerontology: series a bio. sci. & med. sci. (2020); cera cruise & bonnie lashewicz, say what?! ableist logic used in misguided attempt to combat ageism during covid‐19, 69 j. am. geriatrics soc. 47 (2021). 165. stephen j. bartels et al., are nursing homes appropriate for older adults with severe mental illness? conflicting consumer and clinician views and implications for the olmstead decision, 51 j. am. geriatrics soc. 1571 (2003). indiana health law review [vol. 21:311 350 nevertheless, this justification based on difference in achievements might obscure a more fundamental distinction between elder law and disability law. the different historical development of each field results in differences in character. consequently, as will be demonstrated shortly, both fields perceive each other through their own distinct perspectives. this is meant to say that elder law’s interest in disability law demonstrates its multi-faceted nature. disability law’s relatively limited interest in elder law indicates its more radical nature. the history of disability is marked by a distressing chronicle of attempts to “fix” disabled people, the denial of autonomy and authority, marginalization of people with disabilities, as well as the presence of eugenic policies. older people have suffered from discrimination and exclusion but in less absolute and blatant ways or in more ambivalent ways (i.e. in some cases withholding status, social privileges and respect due to old age). this can explain the radical nature of disability discourse in general and disability law in particular. the disability movement aims not only to improve individuals’ lives but also strives to liberate them from oppressive practices. surtees sees a direct connection between the different histories of people with disability and older persons and their respective social change strategies: this different history helps explain why the civil rights model was seen as such a step forward for people with disabilities . . . . the civil rights model was an improvement, and a move closer to the universalism model for people with disabilities. it would not be much of a move forward for elders. certainly, there are individual elders and elder law issues which can and do receive helpful results from the civil rights model. as a group, however, elders generally do not have to take steps in order to move the conversation towards the need to accommodate. that is where the conversation starts. 166 hence the achievements of the disability movement when compared to those of older persons, serve as a reminder of their relatively disadvantaged starting point. another difference between the two movements is related to their leadership. in the field of older persons’ rights, professionals and service providers take the lead in advocating for policy changes, while older individuals themselves have not been actively involved in advocating for their own rights. this is quite different from the disability movement, where self-advocacy and the principle of “[n]othing about us without us” are central and highly valued.167 another important difference is that while old age does not generally form a ————————————————————————————— 166. doug surtees, what can elder law learn from disability law?, in theories on law and ageing: the jurisprudence of elder law 93, 103-04 (israel doron ed., 2009). 167. nina a. kohn, a civil rights approach to elder law, in beyond elder law: new directions in law and aging 19, 24 (israel doron & ann m. soden eds., 2012). 2024] old-age-based and disability-focused 351 cohesive group identity, 168 disability often serves as a significant identity for many individuals. another closely interconnected distinction lies in the fact that old age has not emerged as a unified group identity, whereas disability often holds significant importance as an identity, and in some cases, takes precedence over other identities. 169 these differences in historical, sociological, and political backgrounds, undoubtfully have influenced the difference in character between disability law and elder law. both disability rights discourse and elder law discourse draw upon principles of human rights. however, they interpret and apply these principles differently. disability rights discourse takes a more categorical and dichotomous approach, sharply distinguishing between policies that uphold human rights and those that violate them. in contrast, elder law discourse emphasizes the need to consider a range of flexible solutions and strike a balance between conflicting factors, such as protecting individuals while respecting their autonomy. this contrast is evident in discussions among elder law scholars regarding legal capacity, where the concept of supported decision-making was introduced as an additional legal tool alongside existing mechanisms like lasting power of attorney and guardianship. 170 the conflict between autonomy and the need for care and protection is recognized in elder law as a tension that should be acknowledged. in response, a range of interventions is available to enable individuals and their families to make choices based on their specific needs and preferences. 171 while disability law encourages a variety of legal approaches as long as they conform to the human rights framework, elder law encourages various legal approaches and tactics to reach a fine balance between the different values and needs.172 as summarized by morgan: elder law, so the multi-dimensional model suggests, includes distinct types of legal tools, a range of political and philosophic approaches, and multiple perspectives on the concept of “elder rights.” in other words, this field is by no means directed by a single viewpoint: it cannot be considered either “individualistic” or “paternalistic,” nor can it be portrayed as promoting “negative” as opposed to “positive” rights, or as favoring the individual over the family, the private over the public. elder law covers the range of possible approaches and perspectives, and it can be fully appreciated only by understanding the internal balance ————————————————————————————— 168. nina a. kohn, elder rights: the next civil rights movement, 21 temp. pol. & civ. rts. l. rev. 321, 325 (2012). 169. kohn, a civil rights approach, supra note 167, at 24. 170. charles p. sabatino & erica wood, the conceptualization of legal capacity of older persons in western law, in beyond elder law: new directions in law and aging 35, 3536 (israel doron & ann m. soden eds., 2012). 171. terry carney, guardianship, “social” citizenship, & theorizing substitute decisionmaking law, in beyond elder law: new directions in law and aging 1, 10 (israel doron & ann m. soden eds., 2012). 172. doron, supra note 28, at 71. indiana health law review [vol. 21:311 352 between all of its components. 173 in summary, the differing perspectives of each field can impact how they interact with one another. the majority of old-age-based and disability-focused articles can be attributed to the willingness to adopt elements from disability law and integrate them in the range of solutions available for older persons. the efforts to mark a line between elder law and disability in many articles, can be explained not only by their differences or by ableist bias but also because of a strong notion that these are two distinct fields. the binary treatment of institutions, guardianship, segregated settings in disability law, is at odds with elder law’s approach to these issues. as is the different perspective on the role of professionals and family members. and so, while open to compare and learn from disabilities, elder scholars are careful in marking the line and differentiating both fields. in contrast, disability legal scholars, particularly those adopting a critical perspective, will have mixed feelings about the more moderate approach taken by elder law scholars. the acceptance of segregated settings or the recognition of the necessity for guardianship is perceived as a compromise, and even more so, as a paternalistic compromise imposed by professionals above the heads of older people themselves. this unspoken aspect of the relationship carries significant implications. what elder law considers as balanced and nuanced, can be viewed as a potential threat within the realm of disability law. for instance, if a un convention on older persons’ rights were to recognize the legitimacy of guardianship, it could trigger a backlash against the progress achieved by the disability movement. the relative silence within disability scholarship regarding issues related to older age may reflect an intense silence driven by concerns about the potential outcomes of this relationship. vi. conclusion this study is innovative in its focus on the relationship between elder law and disability law. it demonstrated the rich potential of a direct dialogue between both. this dialogue is currently at an early stage, and it consists not only of what is said and written in current literature but of the silences and subtext in this dialogue. we tried to mark the current common issues and the comparative insights, quantitively and qualitatively. we also tried to bring a wider picture of the relationship between disability rights and elder rights and to understand the tension between both disciplines. one thing is sure, comparative research between disability and elder law has far and wide horizons. when are age boundaries relevant in disability policy, if at all? how can the radical nature of disability studies and the practical problem-solving ————————————————————————————— 173. r. c. morgan, the future of elder law, in theories on law and ageing: the jurisprudence of elder law 145, 148 (israel doron ed., 2009). 2024] old-age-based and disability-focused 353 nature of elder law join forces? how can the disability perspective enrich the lives of people aging into disability and how can the old-age perspective enrich the lives of people aging with disability? these are all questions that need to be addressed and that can influence the lives of many people living at the intersection of age and disability. lastly, we would like to outline several potential research directions that can guide future studies on this issue. this article highlights the scarcity of comparative research in the fields of disability and elder law, emphasizing the potential of this kind of work. there are several types of research that can be undertaken in this regard. first, thematic comparative research can delve into exploring the similarities and differences between elder law and disability law on various shared subjects, such as guardianship, institutionalization, protective measures, accessibility, voting rights, end of life, vulnerability, stigma etc. although legislation may sometimes encompass both populations, practical application of the law and litigation may differ. second, procedural comparative research can focus on examining the legislative processes and the evolution of legal frameworks in both fields. this includes a comparison of the different achievements as well as exploring how variations in the process influence the outcomes. third, epistemological comparative research can explore the different ways in which both fields conceptualize the relationship between law, people with disabilities or older persons. this research can shed light on the unique perspectives and approaches employed by each field. finally, it is time for a direct and constructive dialogue between disability and elder law practitioners, scholars, and stakeholders. this dialogue should encompass discussions surrounding fears, disagreements, potential collaborations, and constructive criticism. only through such a dialogue can each field address its unexplored territory, uncover hidden perspectives, and develop in innovative and productive ways. this article, written by scholars from both fields, is our contribution to this evolving dialogue and serves as an exemplar of its potential. structure bookmarks old-age-based and disability-focused: indiana health law review volume xx 2023 number 2 notes indiana’s efforts to reduce maternal mortality: necessary, but insufficient kasey barnes* i. introduction nearly one-hundred women in indiana die from a pregnancy-related complication each year.1 courtney reimlinger, a twenty-three-year-old indianapolis native was nearly one of them.2 one week after delivering her son, she experienced excruciating chest pain that spread to her head and neck and resulted in periods of unconsciousness.3 courtney was rushed to a local hospital and was diagnosed with postpartum eclampsia, a pregnancy complication that when left untreated, can lead to seizures, strokes, organ damage, and even death.4 after spending a week in the hospital for treatment, courtney recovered.5 unfortunately, the same cannot be said for other indiana women who live in one of the nation’s worst states for maternal mortality. a. the issue maternal mortality is a leading indicator for the overall health quality of a * j.d. candidate, 2023, indiana university – robert h. mckinney school of law— indianapolis; b.s.n., 2012, iu school of nursing at iupui; m.p.h., richard m. fairbanks school of public health at iupui. 1. darian benson, health experts discuss how to lower indiana’s maternal mortality rate, wfyi (may 26, 2021), https://www.wfyi.org/news/articles/health-experts-discuss-how-tolower-indianas-maternal-mortality-rate [https://perma.cc/ua8m-6hzh]. (cisgender women are not the only people who may become pregnant, but i chose to use the term “woman” and “women” in this note to refer to those who experience pregnancy because data collected around maternal mortality generally utilizes the categories of “woman” and “women.”). 2. lauren bavis, why new mothers in indiana are dying at one of the nation’s highest rates, side effects (june 13, 2018, 6:00 am), https://www.sideeffectspublicmedia.org/ community-health/2018-06-13/why-new-mothers-in-indiana-are-dying-at-one-of-the-nationshighest-rates [https://perma.cc/4pzn-yg48]. 3. id. 4. id. 5. id. 358 indiana health law review [vol. 20:357 population.6 multiple factors contribute to maternal mortality including barriers to health care access, missed or delayed diagnoses, racial and ethnic disparities, escalating maternal comorbidities, failure to recognize warning signs, and variable reporting statistics.7 despite an array of contributing factors, each death “reflects a web of missed opportunities” because the majority of maternal deaths are preventable.8 in the united states, maternal mortality has been the focus of recent national attention due to its high rates. moreover, in 2018, indiana ranked the third worst state in the u.s. with a maternal mortality rate of 43.6 deaths per 100,000 live births,9 a rate nearly twice as high as neighboring states such as kentucky, ohio, illinois, and michigan, and twice as high as the national average.10 by comparison, california, massachusetts, and nevada, have some of the lowest rates with 4.0, 8.4, and 8.4 deaths per 100,000 live births, respectively.11 the variability in maternal mortality rates between states is just one example of why improving maternal mortality rates is a complex and challenging issue to improve. even so, solutions exist that prove rates can be lowered if policymakers are willing to support a multifaceted approach. this note discusses policy efforts implemented by the federal government and other states to improve maternal mortality and morbidity rates, including the state of indiana. to decrease indiana’s maternal mortality rate, this note first argues that policy changes must include funding doula support services for medicaid eligible women, reviewing severe maternal morbidity events, expanding home visiting services, requiring implicit bias training for health care providers, and partnering with a statewide health information exchange. part ii describes the rise in maternal mortality over the past seventy years, including counting and identifying maternal deaths, as well as the causes and disparities in maternal mortality. part iii discusses federal and state legislative efforts to address maternal mortality. part iv examines other states’ policy efforts to reduce maternal mortality rates. part v analyzes and argues policies indiana should adopt to decrease maternal mortality rates. finally, part vi concludes by reiterating why indiana’s efforts to improve maternal mortality are necessary, but insufficient to improve indiana’s current unacceptable maternal mortality rate. 6. indiana maternal mortality review committee:2020 annual report, ind. dep’t. health 1, 16 (2020). 7. pregnancy-related deaths, ctr. disease control & prevention, https://www.cdc. gov/vitalsigns/maternal-deaths/index.html [https://perma.cc/tg7g-5xgc] (last updated may 7, 2019). 8. id. 9. laura ungar & carline simon, which states have the worst maternal mortality?, usa today (nov. 1, 2018, 2:26 pm), https://www.usatoday.com/list/news/investigations/maternalmortality-by-state/7b6a2a48-0b79-40c2-a44d-8111879a8336/ [https://perma.cc/5kj9-jqke]. 10. bavis, supra note 2. 11. ungar & simon, supra note 9. 2023] indiana’s efforts to reduce maternal mortality 359 ii. maternal mortality over the last seventy years to best understand maternal mortality and why this note focuses on indiana’s unacceptable high rates, the following section provides details about how maternal mortality is defined and measured, causes of maternal mortality, disparities that exist, and how examining severe maternal morbidity may aid in preventing maternal deaths. a. a premature declared victory in 1950, leaders in medical research made a bold and dramatic claim in the journal of the american medical association—the fight to stop women from dying during childbirth had ended.12 the journal reported that what was once unthinkable, was achieved; the maternal mortality rate dropped to one per 1,000 live births.13 for several decades, maternal mortality rates remained low as a result of healthier living conditions, improved maternity healthcare services, safer surgery procedures, and access to antibiotics.14 obstetric experts in the medical community believe this was a premature declared victory that led to a shift in focus from mothers to babies.15 infant mortality rates continue to reach historic lows, while maternal mortality rates continue to rise, leading some medical experts to conclude that the american health care system has prioritized infant survival over maternal care.16 today, the u.s. has the highest maternal mortality rate among developed countries.17 b. maternal mortality and morbidity rates in the u.s. almost seven-hundred women die each year as a result of complications during pregnancy or delivery.18 according to the centers for disease control and prevention (“cdc”), about three in five pregnancy-related deaths are 12. renee montagne, to keep women from dying in childbirth, look to california, nat’l pub. radio (july 29, 2018, 8:02 am), https://www.npr.org/2018/07/29/632702896/to-keepwomen-from-dying-in-childbirth-look-to-california [https://perma.cc/s634-zh9a]. 13. id. 14. eugene declercq & laurie zephyrin, maternal mortality in the united states: a primer, commonwealth fund (dec. 16, 2020), https://www.commonwealthfund.org/publications/issuebrief-report/2020/dec/maternal-mortality-united-states-primer [https://perma.cc/ees2-fl3l]. 15. montagne, supra note 12. 16. id. (improvements in infant mortality rates have not kept pace with other developed countries.). 17. roosa tikkanen et al., maternal mortality and maternity care in the united states compared to 10 other developed countries, commonwealth fund (nov. 18, 2020), https://www.commonwealthfund.org/publications/issue-briefs/2020/nov/maternal-mortalitymaternity-care-us-compared-10-countries [https://perma.cc/nep8-bnyk]. 18. michael c. lu, reducing maternal mortality in the united states, 320 jama 1237, 1237 (2018). 360 indiana health law review [vol. 20:357 preventable.19 further, an additional fifty-thousand women suffer from maternal morbidity, which includes short or long-term health consequences such as postpartum hemorrhage or hypertensive complications.20 perhaps even more troubling is that the covid-19 pandemic has disrupted maternal health care by altering or cancelling prenatal visits and limiting some birth-related services.21 in fact, the maternal mortality rate increased twenty-percent from 2019 to 2020, illustrating the potential impact the covid-19 pandemic has had on worsening maternal mortality.22 moreover, understanding the true picture of maternal mortality can be difficult due to the different terms classifying maternal mortality and the different methods of counting maternal mortality. 1. classifying and counting maternal deaths the world health organization (“who”) defines maternal mortality as “the death of a woman while pregnant or within [forty-two] days of termination of pregnancy, irrespective of the duration and the site of pregnancy, from any cause related to, or aggravated by the pregnancy or its management, but not from accidental or incidental causes.”23 this definition is used for international comparisons and is expressed as a ratio of deaths per one-hundred-thousand births.24 more specific definitions are used to add value and context to the data regarding maternal mortality. for example, pregnancy-associated death is defined as “death while pregnant or within one year of the end of pregnancy, irrespective of the cause.”25 conversely, the cdc defines a pregnancy-related death as “the death of a woman while pregnant or within [one] year of the end of pregnancy[,]” regardless of the outcome, duration or site of the pregnancy, “from any cause 19. pregnancy-related deaths, supra note 7. 20. analysis of federal bills to strengthen maternal health care, kaiser fam. found. (dec. 21, 2020), https://www.kff.org/womens-health-policy/fact-sheet/analysis-of-federal-bills-tostrengthen-maternal-health-care/ [https://perma.cc/k5d7-pqkm]; nan h. troiano & patricia m. witcher, maternal mortality and morbidity in the united states: classification, causes, preventability, and critical care obstetric implications, 32 j. perinatal & neonatal nursing 222, 227 (2018). 21. steven r. johnson, the u.s. maternal mortality rate surged by nearly 20% in 2020, u.s. news & world rep. (feb. 23, 2022), https://www.usnews.com/news/health-news/articles/ 2022-02-23/u-s-maternal-mortality-rate-surged-in-2020. 22. id.; see also donna l. hoyert, maternal mortality rates in the united states, ctr. disease control & prevention, https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/ maternal-mortality-rates-2020.htm [https://perma.cc/na84-6mum] (last visited mar. 20, 2023). (the u.s. maternal mortality rate increased from 20.1 deaths per 100,000 live births in 2019, to 23.8 deaths per 100,000 live births in 2020.) 23. nan h. troiano & patricia m. witcher, maternal mortality and morbidity in the united states: classification, causes, preventability, and critical care obstetric implications, 32 j. perinatal & neonatal nursing 222, 223 (2018). 24. tikkanen et al., supra note 17. 25. id. 2023] indiana’s efforts to reduce maternal mortality 361 related to or aggravated by the pregnancy or its management” and generally excludes deaths due to injury.26 in other words, pregnancy-associated deaths are a broader category representing all deaths that occur within one year of pregnancy, regardless of the cause, while pregnancy-related deaths are a more narrow category of deaths related to pregnancy or its management.27 for example, a woman’s death caused by a motor vehicle accident within one year of pregnancy would not be counted as a pregnancy-related death, but it would be counted as a pregnancy-associated death. currently two national sources exist for capturing maternal death information. the first source, the national vital statistics system (“nvss”), is part of the u.s. federal statistical system and reports the number of maternal deaths per onehundred-thousand live births.28 the nvss utilizes two pieces of information to identify maternal death. one includes the pregnancy checkbox, and the other is a certified recording of the icd-10 codes used to assign a maternal death, both of which are located in death records.29 the second source, the cdc’s pregnancy mortality surveillance system (“pmss”), is a more rigorous and in-depth review of death records than the nvss, and the review is conducted by medical epidemiologists.30 similar to the nvss, the pmss examines death records for women of reproductive age, but it also incorporates media searches, reporting from public health agencies, and reporting from health care providers to identify maternal deaths from pregnancy through one year postpartum.31 when the cdc began monitoring maternal deaths using the pmss in 1987, the maternal mortality rate was 7.2 deaths per 100,000 live births.32 by 2019, the u.s. rate had nearly tripled to 20.1 deaths per 100,000 live births, the highest among high-income countries.33 the rising rates are even more troubling considering that during this time, global maternal mortality rates among high income countries declined.34 for example, france has the next highest rate of 8.7 deaths per 100,000 live births, while new zealand and norway 26. pregnancy mortality surveillance system, ctr. disease control & prevention, https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillancesystem.htm [https://perma.cc/yj6w-nz6d] (last updated nov. 25, 2020). the u.s. is the only country that utilizes the pregnancy-related deaths as a category and this measurement is usually reported as a ratio of deaths per one-hundred thousand live births. 27. ind. dep’t. health, supra note 6, at 16. 28. troiano & witcher, supra note 20, at 223; pregnancy mortality surveillance system, supra note 26. 29. pregnancy mortality surveillance system, supra note 26. 30. id. 31. id. 32. id. 33. donna l. hoyert, maternal mortality rates in the united states, 2019, ctr. disease control & prevention, https://www.cdc.gov/nchs/data/hestat/maternal-mortality-2021/maternalmortality-2021.htm [https://perma.cc/fg43-abh7] (last updated mar. 23, 2021). 34. tikkanen et al., supra note 17. 362 indiana health law review [vol. 20:357 have the lowest rates of 1.7 and 1.8 deaths per 100,000 live births, respectively.35 the last method of identifying maternal deaths occurs at a state level through maternal mortality review committees (“mmrcs”). mmrcs convene to systematically and comprehensively review deaths that occurred during pregnancy or within one year of the termination of pregnancy.36 mmrcs identify maternal deaths in a similar manner as the pmss through linkage of vital records, but they are able to more thoroughly examine medical and social contributing factors by accessing additional sources of information such as medical records, police investigations, and interviews.37 mmrcs are considered the gold standard in identifying pregnancy-associated deaths because they critically evaluate information related to maternal deaths and subsequently identify solutions to improve care for deaths that are determined to be preventable.38 2. the “pregnancy checkbox” in part, maternal mortality rates have been increasing since 2003 because of changes in reporting of vital statistics. in 2003, a “pregnancy checkbox” was added to death certificates indicating whether a decedent was currently or recently pregnant.39 this checkbox was added to more accurately identify maternal deaths, as rates prior to 2000 are believed to be underreported.40 however, states adopted the checkbox revision at different times between 2003 and 2017, creating difficulty in accurately estimating national trends in maternal mortality prior to 2017.41 improved reporting has undoubtedly contributed to a documented increase in mortality rates; however, this explanation does not sufficiently explain why the u.s. has the highest rate of maternal mortality among developed countries.42 further, variability among maternal mortality rates between states have raised questions about access and availability of family planning methods, as well as the increasing prevalence of chronic medical conditions like obesity, diabetes, and 35. id. 36. susanna l. trost et al., preventing pregnancy-related mental health deaths: insights from 14 us maternal mortality review committees, 2008-2017, 40 health aff.’s 1551, 1552 (2021). 37. troiano & witcher, supra note 20, at 224. 38. ai-ris y. collier & rose l. molina, maternal mortality in the united states: updates on trends, causes, and solutions, 10 neoreviews 1, 3-4 (2019). 39. lauren m. rossen et al., the impact of the pregnancy checkbox and misclassification on maternal mortality trends in the united states, 1999-2017, 44 vital & health stat. 1, 2 (2020). 40. id. 41. id. 42. michael r. kramer et al., changing the conversation: applying a health equity framework to maternal mortality reviews, 221 am. j. obstetrics & gynecology 609, 609 (2019). 2023] indiana’s efforts to reduce maternal mortality 363 heart disease.43 moreover, advanced maternal age, high rates of cesarean deliveries, the opioid epidemic, and limited access to quality care in the perinatal period have been cited as potential contributors to the increased rates.44 c. causes of maternal mortality the leading causes of maternal mortality differ depending on whether the death occurs during or after pregnancy.45 for example, hemorrhages and cardiovascular conditions are responsible for most deaths during pregnancy.46 during delivery, obstetric emergencies such as hemorrhage and an amniotic fluid embolism are responsible for the most deaths.47 in the week following delivery, hemorrhage, hypertension, and infections are the most common causes of death.48 cardiomyopathy is the leading cause beyond the week after delivery.49 overall, heart disease and stroke are responsible for most maternal deaths.50 d. disparities in maternal mortality since the beginning of comprehensive data collection for maternal mortality in 1915, disparities between black and white maternal mortality ratios have existed.51 rates declined more quickly for white mothers as compared to black mothers after world war ii, and that disparity continued to increase until today.52 in 2019, the maternal mortality rate for non-hispanic black women was 44.0 deaths per 100,000 live births, a rate double that of non-hispanic white women (17.9) and triple of hispanic women (12.6).53 in other words, black women are three to four times more likely to die of pregnancy-related causes than white women.54 racial and ethnic disparities in maternal mortality rates are attributable to the “legacy of structural racism that permeates people’s lived experiences, including experiences in the health care system.”55 notably, between 2005 and 2013, 12.3% of black respondents reported experiencing racial discrimination in a health care setting as compared to 2.3% of white respondents in a nationally representative 43. collier & molina, supra note 38, at 2. 44. id. 45. pregnancy-related deaths, supra note 7. 46. declercq & zephyrin, supra note 14. 47. pregnancy-related deaths, supra note 7. 48. id. 49. id. 50. id. 51. declercq & zephyrin, supra note 15. in 1915, the black maternal mortality ratio was 1,065 deaths per 100,000 births compared to 601 deaths per 100,000 births for whites. 52. id. 53. hoyert, supra note 33, at 3. 54. benson, supra note 1. 55. collier & molina, supra note 38, at 7. 364 indiana health law review [vol. 20:357 survey.56 further, a study at an academic health center in chicago found that healthcare providers were more than twice as likely to describe black patients using one or more negative patient descriptors in the electronic health records as compared to their white counterparts.57 further, disparities are not limited to race and ethnicity. women living in rural parts of the country experience greater risks during childbirth than women in urban areas.58 e. examining severe maternal morbidity maternal mortality is considered only the “tip of the iceberg” of an even larger phenomenon of adverse maternal outcomes impacting women across the u.s. known as severe maternal morbidity (“smm”).59 smm is defined as “unexpected outcomes of labor and delivery that result in significant shortor long-term consequences to a woman’s health.”60 in fact, for every maternal death, an estimated one-hundred episodes of smm occur.61 in 2014, it was estimated that smm affected more than fifty-thousand women.62 56. irena stepanikocva & gabriela r. oates, perceived discrimination and privilege in healthcare: the role of socioeconomic status and race, 52 am. j. preventive med. s86, s88 (2016). the behavioral risk factor surveillance system (“brfss”) is a national telephone survey that collects state data about u.s. residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services. 57. michael sun et al., negative patient descriptors: documenting racial bias in the electronic health record, 41 health aff.’s 203, 203 (jan. 19, 2022). these findings persisted after controlling for sociodemographic and health characteristic variables. fifteen negative descriptors were used such as noncompliant, hysterical, challenging, defensive, unpleasant, refuse, and exaggerate. 58. katy backes kozhimannil et al., beyond the preventing maternal deaths act: implementation and further policy change, health aff. (feb. 4, 2019), https://www. healthaffairs.org/do/10.1377/hblog20190130.914004/full/ [https://perma.cc/3wau-wae8]. 59. sophie wheelock et al., complications of childbirth: racial & ethnic disparities in severe maternal morbidity in new york state, n.y. state health found. 1, 2 (2020), https://nyshealthfoundation.org/wp-content/uploads/2020/08/severe-maternal-morbidity.pdf [https://perma.cc/8vdn-h4cz]. 60. severe maternal morbidity in the united states, ctr. disease control & prevention, https://www.cdc.gov/reproductivehealth/maternalinfanthealth/severematernalmorbidity.html [https://perma.cc/zrq7-49g3] (last updated feb. 2, 2021). this is the most recent year that smm data is available. smm is not limited to poor health outcomes for women, but also increases fetal deaths and infant mortality. 61. press release, am. coll. obstetricians & gynecologists, national initiative aimed at reducing maternal deaths shows early signs of improvement in severe maternal morbidity (jan. 2, 2018), https://www.acog.org/news/news-releases/2018/01/national-initiative-aimed-at-reducingmaternal-deaths-shows-early-signs-of-improvement-in-severe-maternal-morbidity [https://perma.cc/3zbu-hwv3]. 62. severe maternal morbidity in the united states, supra note 60. this is the most recent year that smm data is available. smm is not limited to poor health outcomes for women, but also 2023] indiana’s efforts to reduce maternal mortality 365 women who experience a pregnancy-related death typically progress along a continuum; normal pregnancy, morbidity, severe morbidity, near-miss morbidity, to maternal death.63 postpartum hemorrhage and hypertensive complications account for two-thirds of smm events.64 it is unclear why smm rates are steadily increasing, but factors related to the overall health of women such as increased maternal age, obesity, and other preexisting chronic health conditions may be contributing.65 health experts argue that cases of smm merit quality review because like maternal mortality, smm has a high rate of preventability.66 systematic reviews of smm events provides a proactive approach to provide quality improvement in obstetric care that could stop the progression from morbidity to maternal death, given that smm occurs at a significantly higher frequency than maternal deaths.67 furthermore, smm is often considered a “near miss” for maternal mortality because identifying and treating these conditions can help avoid death.68 while health experts are advocating for hospitals to review smm cases, this endeavor may be slightly difficult because to date, there is not complete consensus among health care professionals about which conditions should represent smm.69 despite this lack of consensus, the american college of obstetricians and gynecologists (“acog”) encourages institutions to adopt an existing screening criteria, or to create their own list of outcomes to review based on the determination of which conditions are consequential to their population.70 the cdc also standardized a list of twenty-one indicators that correspond to international classification of diseases (“icd”) diagnosis and procedure codes to identify smm cases, which could serve as a resource for those wanting to examine smm.71 it is also important to note that some morbidity cases reflect the underlying health conditions of a woman and therefore are unavoidable. for example, if a physician plans to admit a woman to an intensive care unit for observation and to receive safe intrapartum care because of a known congenital heart disease, this would not be considered a smm event.72 conversely, a woman who develops acute heart failure and requires significant interventions to manage the heart increases fetal deaths and infant mortality. 63. troiano & witcher, supra note 23, at 227. 64. id. 65. severe maternal morbidity in the united states, supra note 60. 66. sarah k. kilpatrick & jeffrey l. ecker, severe maternal morbidity: screening and review, 215 am. j. obstetrics & gynecology b17, b17-18 (2016). 67. id. at b17. 68. id. at b18. 69. id. 70. id. 71. severe maternal morbidity in the united states, supra note 60. 72. kilpatrick & ecker, supra note 66, at b18. 366 indiana health law review [vol. 20:357 failure would be considered a smm event.73 while it is true that not all cases of morbidity are preventable, it is still critically important to review cases in detail to determine if changes in the delivery of care is needed to ensure quality obstetric care is provided.74 preventing smm is a key component for reducing maternal mortality, however many states’ mmrcs, including indiana’s mmrc, do not review smm cases.75 iii. legislative efforts to address maternal mortality both the united states congress and the indiana general assembly have enacted policies to reduce maternal mortality rates. this section describes those recently enacted federal and state policies, with a particular focus on the creation of indiana’s own mmrc and the mmrc’s findings. a. recent federal legislative efforts long overdue, given the persistent high rates of maternal mortality, congress passed the preventing maternal deaths act of 2018 (“pmda”), allowing the cdc to establish state and tribunal mmrcs and increase support for existing mmrcs.76 beginning in 2019 and lasting through 2023, the law provides fiftyeight million dollars annually to fund prevention research, preventive programs, and mmrcs.77 in the wake of passing the pmda, congress introduced nearly three dozen bills during the 2019-20 legislative session.78 these bills addressed a number of issues pertaining to maternal health including devoting funding for health equity and implicit bias training for clinical providers, extending medicaid postpartum coverage beyond sixty days, broadening obstetric support in rural areas, and providing medicaid coverage for doula care.79 only two of these bills made it past the introduction phase, and both bills died in the senate.80 additionally, the american rescue plan act of 2021 (“arp”) fills in a gap that exists for many low-income women in the postpartum period by allowing states the option to extend medicaid postpartum coverage from sixty days to twelve months.81 states that elect to extend the postpartum coverage period to one year may do so by filing a state plan amendment to their medicaid program.82 73. id. 74. id. 75. see ind. dep’t. health, supra note 6. 76. preventing maternal deaths act, 42 u.s.c. § 247b-12. 77. id. the preventing maternal deaths act is an amendment to the public health service act, which implements the safe motherhood initiative of the cdc. 78. analysis of federal bills to strengthen maternal health care, supra note 20. 79. id. 80. analysis of federal bills to strengthen maternal health care, supra note 20; see also helping medicaid offer maternity services act of 2020, h.r. 4996, 116th cong. (2020); and maternal health quality improvement act of 2020, h.r. 4995, 116th cong. (2020). 81. 42 u.s.c. § 1396a(e)(16)(a). 82. usha ranji et al., postpartum coverage extension in the american rescue plan act of 2023] indiana’s efforts to reduce maternal mortality 367 this statute also requires states to provide the full set of medicaid benefits, rather than the narrow set of pregnancy-related benefits that is currently allowed.83 extending postpartum coverage to a full year is an important policy to address the largely preventable maternal mortality and morbidity rates, specifically to address the racial and ethnic disparities that exist.84 additionally, it is an important strategy to address many conditions that significantly impact pregnancy-related mortality and morbidity such as hypertension and depression, both of which generally require long-term care.85 moreover, providing extended medicaid coverage to low-income women increases accessibility of preventive services such as family planning services and intrapartum care.86 notably, funding for medicaid’s extended coverage will expire after five years unless congress reauthorizes the funding or amends it to become permanent.87 b. indiana’s recent legislative efforts the indiana general assembly has historically supported committees and commissions that focus specifically on issues that hoosier women face.88 for example, the bipartisan indiana commission for women (“icw”) was established in 1992 by a gubernatorial executive order and later codified in 1996 to signify “indiana’s commitment to improving the quality of life for women and families.”89 notably, one of icw’s duties includes assessing the health care needs of indiana women.90 similarly, the office of women’s health (“owh”), housed within the indiana department of health (“idoh”), was established in 1998 and later codified in 1999.91 owh is responsible for assisting the state health commissioner in “identifying, coordinating, and establishing priorities for programs, services, and resources [indiana] should provide for women’s health 2021, kaiser fam. found. (mar. 18, 2021), https://www.kff.org/policy-watch/postpartumcoverage-extension-in-the-american-rescue-plan-act-of-2021/ [https://perma.cc/99tc-xn2s]. 83. id. 84. id. 85. id. 86. id. 87. whitney downard, federal provision could change indiana’s maternal mortality, herald bull. (apr. 2, 2021), https://www.heraldbulletin.com/news/state_news/federal-provisioncould-change-indianas-maternal-mortality/article_ffac827a-93da-11eb-b0b8-9745d10ad55c.html [https://perma.cc/lp9y-uqjg] . 88. see ind. code § 4-23-25-7 (2021); ind. code § 16-19-13-3 (2021). 89. indiana commission for women about us, in.gov, https://www.in.gov/icw/about-us/ [https://perma.cc/pu2s-4v74] (last visited feb. 4, 2022). 90. ind. code § 4-23-25-7(1)(f) (2021). 91. office of women’s health history, in.gov, https://www.in.gov/health/owh/aboutwomens-health/history/ [https://perma.cc/k6tq-845p] (last visited feb. 4, 2022). 368 indiana health law review [vol. 20:357 issues. . .relating to the reproductive, menopausal, and postmenopausal phases of a woman’s life, with an emphasis on postmenopausal health.”92 further, owh is tasked with recommending programs for the state health commissioner to include for idoh’s budget, seeking funding to carry out its purposes, and upon request, representing the state health commissioner before the general assembly and the icw.93 while it is clear indiana lawmakers support committees that assess the health needs of women and make recommendations based on those assessments, it is less clear whether lawmakers equally support implementing needed recommendations. for example, during the 2020 legislative session, a bill requiring employers to make reasonable accommodations for pregnant employees failed to be enacted.94 three of the four indiana general assembly members serving on the icw co-authored or sponsored the bill, emphasizing the importance of the law for women’s health.95 furthermore, the law was supported by the governor and the state health commissioner as an important measure to prevent preterm labor and ultimately improve the health of pregnant mothers and their babies.96 instead of joining twenty-five other states that require reasonable accommodations for pregnant workers, the indiana general assembly enacted a law requiring an employer to “respond to an employee’s request . . . within a reasonable time[,]”specifically stating that an employer is not required or obligated to provide an accommodation per the request.97 1. indiana’s maternal mortality review committee in response to indiana’s abysmal rate, the indiana general assembly passed indiana code section 16-50-1-3 to establish a statewide mmrc.98 indiana’s mmrc is also supported by the pmda that congress enacted to provide states with financial and technical support to improve maternal mortality.99 under indiana code section 16-50-1-3(a)(1)-(4) the mmrc is established to: (1) “review cases of maternal morbidity and maternal mortality; (2) determine factors contributing to maternal morbidity and maternal 92. ind. code § 16-19-13-3(2) (2021) (emphasis added). 93. ind. code §§ 16-19-13-3(6), (7), (11) (2021). 94. s.b. 342, 121st gen. assemb., 2d reg. sess. (ind. 2020). 95. see id.; commissioners, in.gov, https://www.in.gov/icw/about-icw/commissioners/ [https://perma.cc/a3ch-awg8] (last visited feb. 4, 2022). 96. kayla sullivan, governor holcomb wants accommodations for pregnant workers, fox 59 (dec. 12, 2019), https://fox59.com/news/gov-holcomb-wants-accommodations-for-pregnantworkers/ [https://perma.cc/lb9s-q8tk]. 97. ind. code § 22-9-12-3 (2021). employers with at least fifteen employees may be required to provide reasonable accommodations to pregnant workers under the american with disabilities act amendments act of 2008. see 42 u.s.c. § 12101. 98. ind. code §§ 16-50-1-3(a)(1)-(4) (2021). 99. 42 u.s.c. § 247b-12(a)(1). 2023] indiana’s efforts to reduce maternal mortality 369 mortality; (3) identify public health and clinical interventions to improve systems of care and enhance coordination; and (4) develop strategies for the prevention of maternal morbidity and maternal mortality.”100 further, the statute states that the mmrc “shall review cases involving the death of a woman occurring during pregnancy, irrespective of the duration and site of the pregnancy, through one (1) year after the pregnancy; and may review cases of maternal morbidity[.]”101 thus, the mmrc must review all maternal mortality cases in indiana, but it is not required to review maternal morbidity cases. 2. indiana and medicaid expansion indiana lawmakers proposed bills in the 2020 and 2021 legislative sessions extending the pregnancy medicaid coverage period from sixty days to one year postpartum.102 the indiana mmrc also made this medicaid policy recommendation in its 2020 annual report.103 despite the proposed bills and mmrc recommendation, the bills failed to pass.104 yet, indiana elected to extend medicaid under the federal arp, meaning that medicaid-eligible pregnant women in indiana would continue to receive medicaid benefits for twelve months postpartum rather than the previous sixty-day limit.105 notably, this was a temporary measure that was due to expire in 2026 unless congress or the indiana general assembly passed legislation to permanently extend medicaid benefits through one year postpartum.106 fortunately, during the 2022 legislative session, the indiana general assembly voted to permanently expand medicaid coverage for pregnant women to “at least [sixty] days but not more than [twelve] months.”107 moreover, the bill expands medicaid access by increasing the income eligibility requirements.108 100. ind. code §§ 16-50-1-3(a)(1)-(4) (2021). 101. ind. code §§ 16-50-1-3(b)(1)-(2) (2021) (emphasis added). 102. h.b. 1155, 122nd gen. assemb., reg. sess. (ind. 2021); h.b. 1248, 121st gen. assemb., reg. sess. (ind. 2020). 103. ind. dep’t health, supra note 6, at 43. 104. ind. h.b. 1155; ind. h.b. 1248. 105. brandon smith, indiana expanding medicaid coverage to new mothers 12 months postpartum, wfyi indianapolis (apr. 19, 2021), https://www.wfyi.org/news/articles/indianaexpanding-medicaid-coverage-to-new-mothers-12-months-postpartum [https://perma.cc/4gtd9l2l]. 106. downard, supra note 87. 107. h.b. 1140, 123rd gen. assemb., reg. sess. (ind. 2022). 108. id.; press release, indiana house democratic caucus, summer commends passage of medicaid expansion for pregnant women, more action needed in 2023 (mar. 7, 2022), 370 indiana health law review [vol. 20:357 additionally, the bill eliminates the pregnancy medicaid limitation that medical assistance coverage only applied to pregnancy-related services.109 the importance of the indiana general assembly permanently extending medicaid coverage beyond sixty days to potentially a full year cannot be overstated. the year after delivery is a medically vulnerable period for women who may be suffering from childbirth complications, anxiety, or depression, and it is a period when many maternal mortality cases occur.110 traditionally, postpartum care was centered around one clinical visit about eight weeks after delivery; however, it is becoming increasingly understood that postpartum care is an ongoing process, potentially requiring multiple visits and follow up care beyond eight weeks.111 in fact, the majority of pregnancy-associated deaths in indiana occur after six weeks postpartum, highlighting this policy’s integral role in protecting the health of postpartum women.112 3. doula services under indiana medicaid indiana enacted a law that provides reimbursement for doula services for medicaid recipients in 2019, signaling that the indiana general assembly was committed to taking action to mitigate the state’s maternal mortality crisis.113 at that time, indiana was only the third state to extend medicaid to cover doula care.114 doulas provide physical, emotional, and educational support and encouragement for women during labor, delivery, and the postpartum period.115 doula support helps lead to better birth outcomes by supporting women in foregoing epidurals, avoiding unnecessary cesarean deliveries, and having less stressful births overall.116 notably, the positive impact that doula support provide is shown to be greater for women who are “socially disadvantaged, low income, unmarried, primiparous, giving birth in a hospital without a companion, or had https://indianahousedemocrats.org/news-media/summers-commends-passage-of-medicaidexpansion-for-pregnant-women-more-action-needed-in-2023 [https://perma.cc/j6j3-fttz]. 109. ind. h.b. 1140; press release, ind. house democratic caucus, summers commends passage of medicaid expansion for pregnant women, more action needed in 2023 (mar. 7, 2022), https://indianahousedemocrats.org/news-media/summers-commends-passage-of-medicaidexpansion-for-pregnant-women-more-action-needed-in-2023 [https://perma.cc/j6j3-fttz]. 110. usha ranji et al., expanding postpartum medicaid coverage, kaiser fam. found. (mar. 9, 2021), https://www.kff.org/womens-health-policy/issue-brief/expanding-postpartummedicaid-coverage/ [https://perma.cc/6vmr-hnsc]. 111. id. 112. ind. dep’t health, supra note 6, at 27. 113. ind. code § 12-15-5-7(a) (2021). 114. jill sheridan, indiana moves to expand medicaid coverage for doulas, wfyi indianapolis (apr. 22, 2019), https://www.wfyi.org/news/articles/indiana-moves-to-expandmedicaid-coverage-for-doulas [https://perma.cc/pya7-s3tb]. 115. kenneth j. gruber et al., impact of doulas on healthy birth outcomes, 22 j. perinatal educ. 49, 49 (2013). 116. id. 2023] indiana’s efforts to reduce maternal mortality 371 experienced language/cultural barriers.”117 instead, the $20,000 that was included in the state budget and to be matched with federal dollars, was stripped from the bill during the final days of the 2019 legislative session, making it unclear how the law moves forward without the necessary financial means.118 given that medicaid pays for half of all indiana births, this law would greatly improve access to doulas for low-income, vulnerable families.119 in reality, without funding for these services, the law has little effect on improving maternal mortality in the state. further, indiana lawmakers have introduced several bills in the 2021 legislative session aiming to improve maternal health, including a bill allowing doulas to directly bill medicaid for their services, but the bills received little to no attention.120 c. indiana’s maternal mortality review committee findings indiana’s mmrc produced its first annual report in 2020, which included key findings, opportunities for intervention, and multi-level recommendations based on its review of the pregnancy-associated and pregnancy-related deaths that occurred in 2018.121 the indiana mmrc used multiple methods to identify maternal deaths. one method included reviewing death certificates to verify if the “pregnancy checkbox” was marked to identify whether a woman was pregnant at the time of death or within the past year.122 an additional method included matching death certificates to birth and fetal death records, as death certificates for any woman between the ages of ten and sixty are linked with birth and fetal death records that occurred within the previous two years.123 further, the indiana hospital association and indiana hospitals must report any known pregnancyassociated deaths to the indiana department of health (“idoh”).124 lastly, to identify how a woman died, whether her death was preventable, or whether other contributing factors existed, the indiana mmrc follows the cdc’s recommendations and gathers additional information from medical records, social service records, and law enforcement records where applicable.125 in indiana, the pregnancy-associated mortality ratio in 2018 was 77.2 per 100,000 live births, while the pregnancy-related mortality ratio was 12.2 per 117. id. at 50. 118. jill sheridan, funding for doulas cut out of budget, ind. pub. radio (apr. 26, 2019), https://indianapublicradio.org/news/2019/04/funding-for-doulas-cu t-ou t-of-budget/ [https://perma.cc/gmv4-lkc6]. 119. sheridan, supra note 114. 120. downard, supra note 87. 121. see ind. dep’t health, supra note 6. 122. ind. dep’t. health, supra note 6, at 19. 123. id. 124. ind. code § 16-50-1-6 (2021). 125. ind. dep’t. of health, supra note 6, at 19-20. 372 indiana health law review [vol. 20:357 100,000 live births through its method of case identification.126 specifically, the mmrc determined that forty-seven deaths were pregnancy-associated127 meaning, a “death while pregnant or within one year of the end of pregnancy, irrespective of the cause.”128 further, the mmrc determined ten deaths in indiana were pregnancy-related, meaning that those deaths were a “direct result of a pregnancy complication, a chain of events initiated by pregnancy, or the aggravation of an unrelated condition by the physiological effects of pregnancy.”129 the complicated issue with these ratios, as calculated by the indiana mmrc, is that they differ greatly from the rates provided by the pmss, making it challenging to compare indiana’s maternal mortality ratios to the national average and other states.130 furthermore, the 2018 mortality ratios as calculated by the indiana mmrc should not be used for comparisons to any rates based on pmss or other data, unless that data originates from a comparable mmrc that analyzes their own pregnancy-related deaths.131 despite the challenges that now come with comparing the indiana mmrc ratios to past rates in indiana, the annual report highlights several important findings that are critical to consider when examining strategies to reduce indiana’s maternal mortality. first, the report confirmed that indiana is not immune to the racial disparities that exist within maternal mortality. the ratio of pregnancy-associated deaths by race indicates that black women are more likely to die during childbirth (103.1 per 100,000 live births) than their white counterparts (86.0 per 100,000 live births).132 next, 70% of pregnancy-related deaths occurred during pregnancy or within the first week of the postpartum period, while 65% of pregnancyassociated deaths occurred after six weeks postpartum.133 moreover, 10% of pregnancy-related deaths occurred among women living in an ob desert.134 an ob desert means there is limited access, or no maternity healthcare services available.135 more than a quarter of indiana counties are ob deserts,136 and given the proportion of births that occur in those counties, the mmrc reported it expected this figure.137 notably, substance use disorder was the most prevalent contributing factor 126. id. at 23. 127. id. at 22. 128. tikkanen et al., supra note 17. 129. ind. dep’t. health, supra note 6, at 22. 130. id. at 23-24. 131. id. 132. id. at 25. 133. id. at 27. 134. id. at 28. 135. jill sheridan, report: 27 percent of hoosiers counties considered ‘maternal care deserts, wfyi indianapolis (oct. 10, 2018), https://www.wfyi.org/news/articles/report-27percent-of-hoosier-counties-considered-maternal-care-deserts [https://perma.cc/43yd-3hfw]. 136. id. 137. ind. dep’t. health, supra note 6, at 28. 2023] indiana’s efforts to reduce maternal mortality 373 to maternal deaths, occurring in 49% of pregnancy-associated deaths.138 additionally, the mmrc concluded that mental health conditions (excluding substance use) either definitely or likely contributed to 38% of pregnancyassociated deaths.139 the committee also noted a heavy overlap existed between the occurrence of substance use disorder and other mental health conditions.140 finally, the mmrc concluded that 87% of pregnancy-associated deaths were preventable as compared to 90% of pregnancy-related deaths.141 iv. other states’ efforts to address maternal mortality other states such as new york, michigan, and california have implemented policies to reduce maternal mortality that indiana has yet to enact. thus, this section analyzes those policies and their potential to prevent future maternal deaths, so that indiana may have a roadmap to address its own policy gaps. a. new york efforts the new york city health department recently became the first city in the country to implement smm surveillance in an effort to ensure that lifethreatening complications at childbirth are included in case reviews to promote health equity, reduce disparities in maternal health, and to create supportive materials for other jurisdictions.142 even with the lack of a consensus definition for smm, obstetric healthcare experts recommend that smm cases are reviewed as it is an “important step toward promoting safe obstetric care.”143 additionally, new york included in its state budget an investment totaling $8 million over two years to improve maternal health initiatives like a perinatal data warehouse.144 modeled after the california maternal data center, this data warehouse may add significant value by creating comparative maternal performance measures for hospitals and other perinatal providers by linking vital statistics, electronic medical records, and autopsy reports.145 this type of data warehouse allows for real-time monitoring and gives the state the ability to assess adverse outcomes in a timely manner, rather than 138. id. at 35. substance use disorder and how the opioid epidemic has impacts maternal mortality and infant health is an important issue that extends beyond the scope of this note. 139. id. 140. id. 141. id. at 37. 142. press release, n.y.c. health, health department receives $1.8 million grant to reduce disparities in maternal health and to support improvements in maternal care across the city (feb. 23, 2018), https://www.nyc.gov/site/doh/about/press/pr2018/pr014-18.page [https://perma. cc/y9qe-4qyv]. 143. kilpatrick & ecker, supra note 66, at b17. 144. wheelock et al., supra note 59, at 32. 145. id.; see infra section c. (discussing california maternal data center.) 374 indiana health law review [vol. 20:357 studying multiple cases in a single period of review.146 while it is too early to know if these initiatives will lower maternal mortality or smm rates, they will nonetheless provide transparency to healthcare consumers. in particular, these initiatives empower pregnant healthcare consumers to make informed decisions about where they may want to deliver based on comparisons of maternal performance measures.147 b. michigan efforts michigan has a long history of supporting maternal health. in 1950, a collaborative effort between the state’s public health agency and medical society formed a maternal death review process.148 further, michigan has utilized medicaid to help finance home visiting for more than two decades through the medicaid maternal and infant health program (“mihp”).149 mihp is available to all pregnant women enrolled in medicaid, and aims to promote healthy pregnancies and birth outcomes through home visiting services provided by teams of social workers, nurses, and dieticians.150 while michigan’s maternal mortality was still too high at 16.4 deaths per 100,000 in 2018,151 it was far better than indiana’s 24.5 deaths per 100,000.152 this evidence further illustrates that this type of state support and investment makes a difference. additionally, michigan recently passed administrative rules requiring licensed health care providers to receive implicit bias training in an effort to address health care disparities and improve equity in the delivery of health care services.153 new applicants for licensure must complete two hours of training and those applying for license renewal must complete at least one hour of training.154 the training may cover an array of topics that relate to implicit bias, but it must include strategies to reduce disparities in accessing healthcare services, as well 146. id. 147. id. at 4. 148. michigan maternal mortality surveillance, mich. dep’t health & hum. serv.’s, h t tps:/ /www.mich igan .gov/mdhhs/0 ,5885,7-339-73971_4911_87421---,00 .h tml [https://perma.cc/yd3d-9qdc] (last visited mar. 20, 2023). 149. johnson grp. consulting, inc.. medicaid and home visiting: the state of states’ approaches 1, 16 ( 2019). 150. id. 151. peristats michigan, march dimes, https://www.marchofdimes.org/peristats/view subtopic.aspx?reg=26&top=6&stop=370&lev=1&slev=4&obj=35 [https://perma.cc/n33y-92z3] (last visited mar. 20, 2023). 152. id. 153. press release, gretchen whitmer, governor gretchen whitmer and lara announce adopted training requirement to improve equity across michigan’s health care system (june 1, 2021), https://www.michigan.gov/whitmer/0,9309,7-387-90499_90640-561034--,00.html [https://perma.cc/7x79-4es5]. 154. id. 2023] indiana’s efforts to reduce maternal mortality 375 as preand post-self-assessments.155 c. california efforts california has become a beacon for improving maternal health outcomes since it formed the california maternal quality care collaborative (“collaborative”) in 2006.156 between 2006 and 2013, the maternal mortality rate decreased from 16.9 to 7.3 maternal deaths per 100,000 live births, or a 57% reduction.157 this reduction was achieved by an array of strategies, including the launch of a statewide quality improvement initiative aiming to improve the quality and safety of maternity care in hospitals.158 the collaborative began by reviewing maternal deaths from the previous five years and identified that when hemorrhage and preeclampsia are treated properly, it offers the greatest chance for survival.159 the collaborative created innovative toolkits that promoted a standardized approach in treating obstetrical emergencies by providing best practices, educational tools, sample protocols, and policies.160 impressively, a control trial involving 147 california hospitals revealed that implementing the toolkit to address obstetrical hemorrhage led to a 20.8% reduction in smm hemorrhaging episodes.161 taking notice of this impressive reduction, in 2015, the maternal and child health bureau and health resources and services administration, launched the alliance for innovation in maternal health (“aim”) program, which is led by acog.162 similar to california’s quality improvement toolkits, the aim program has designed safety bundles to aid providers, hospitals, and health systems, in improving the “4rs”—readiness, recognition, response, and reporting.163 further, california developed a robust statutory scheme, implementing more than twenty policy actions to improve maternal health—more than any other state.164 while some may contend that california may be over-legislating when it comes to maternal health policies, it is difficult to ignore that california has 155. mich. admin. code r. 338.7004(2)(3)(2021); see id. 156. montagne, supra note 12. 157. lu, supra note 18. 158. id. 159. montagne, supra note 12. 160. lu, supra note 18. 161. id. at 1238; see also jeanne mahoney, the alliance for innovation in maternal health care: a way forward, 61 clinical obstetrics & gynecology 400, 401 (2018). 162. lu, supra note 18, at 1238; jeanne mahoney, the alliance for innovation in maternal health care: a way forward, 61 clinical obstetrics & gynecology 400, 401 (2018). 163. lu, supra note 18, at 1238. 164. state policies to improve maternal health outcomes, commonwealth fund (nov. 19, 2020), https://www.commonwealthfund.org/publications/maps-and-interactives/2020/nov/statepolicies-improve-maternal-health-outcomes [https://perma.cc/6gn7-5awf]. 376 indiana health law review [vol. 20:357 managed to cut its maternal mortality rate in half.165 the decrease in maternal mortality rates in california is in stark contrast to the situation occurring in the rest of the country,166 and it is undoubtedly because of the collaborative’s quality improvement efforts strengthened by enacted state policies to support these efforts. for example, one statute requires that any hospital that provides perinatal care must implement an evidenced-based implicit bias program for all health care providers providing perinatal care to patients.167 implicit bias training is required every two years and must include a curriculum that provides information about communicating more effectively across racial, ethnic, and religious identities, as well as identifying previous or current unconscious bias and misinformation, among several other topics.168 california also requires the state department of public health to collect and track data on smm, including conditions such as obstetric hemorrhage, hypertension, preeclampsia and eclampsia, venous thromboembolism, sepsis, cerebrovascular accident, and an amniotic fluid embolism.169 to better understand and prioritize addressing these events, california established what may be described as a “low burden, rapid-cycle data system.”170 the maternal data center is a “real-time” data warehouse that depends on already collected data from birth certificates, as well as hospital discharge diagnosis files for both mothers and infants.171 this approach means that over 98% of data elements are automatically transmitted into the maternal data center, reducing the need for expensive chart reviews.172 in total, this data warehouse creates over fifty maternal and infant performance measures that help hospitals track progress and compare outcomes with other hospitals.173 additionally, medi-cal also provides targeted case management services to at-risk pregnant women and infants through evidenced based programs such as nurse family partnership and healthy families of america, as well as other local community-based organizations.174 these programs are highly effective and provide in-home support, services, and education for vulnerable families beginning in pregnancy and continuing through early childhood.175 165. montagne, supra note 12. 166. elliot k. main et al., addressing maternal mortality and morbidity in california through public-private partnerships, 37 health aff.’s 1484, 1485 (2018). 167. cal. health & safety code § 123630.3(a) (2021). 168. cal. health & safety code § 123630.3 (2021). 169. cal. health & safety code §§ 123630.4(a)(1)-(7) (2021). 170. main et al., supra note 166. 171. id. 172. id. 173. id. 174. rachel herzfeldt-kamprath et al., medicaid and home visiting, ctr. am. progress (jan. 25, 2017), https://www.americanprogress.org/issues/early-childhood/reports/2017/01/25/ 297160/medicaid-and-home-visiting/ [https://perma.cc/v57p-8pks]. (medi-cal is california’s medicaid health care program). 175. id. 2023] indiana’s efforts to reduce maternal mortality 377 most recently, california is receiving praise for its passage of the california momnibus act.176 notably, this bill addresses racial and socio-economic factors that contribute to higher rates of maternal mortality in communities of color.177 the momnibus act codifies the work of the pregnancy associated mortality review committee, which includes not only analyzing pregnancy-related deaths, but also analyzes common indicators of smm to reduce near-miss events.178 importantly, the statute provides that to the degree practicable, family members, support persons, and members of the medical team with direct knowledge or involvement in a maternal death or smm event should be interviewed to gain qualitative information of the circumstance.179 finally, it builds on the 2021-2022 state budget priorities by providing doula services for medi-cal recipients and extending medi-cal eligibility for postpartum women from sixty days to one year after delivery.180 v. policy recommendations for indiana given california’s incredible success of reversing its maternal mortality rate and becoming a state with one of the lowest rates, it would seem logical that indiana adopt a similar statutory scheme. although california’s efforts to decrease maternal mortality rates are laudable, it is important to keep in mind that california’s success cannot be attributed to any single factor or statute. further, to improve maternal mortality in indiana, it is imperative that the recommendations are tailored to the needs of indiana women. this section argues for an array of policies that indiana should enact. while these recommendations are based on policies similar to new york, michigan, and california, they are also based on recommended best practices. importantly, several of these policy recommendations align with what indiana’s own mmrc is recommending. a. indiana’s mmrc shall review smm events first, indiana should amend indiana code section 16-50-1-3(b)(2) to require the mmrc to review smm cases, rather than allowing it to be optional. several studies of small datasets utilize smm as a surrogate for maternal mortality because smm is believed to be a “near miss” that leads to increased risk of 176. press release, march of dimes, march of dimes hails new california law to reduce black maternal and infant death (oct. 5, 2021), https://www.marchofdimes.org/news/march-ofdimes-hails-new-californ ia-law-to-reduce-black-maternal-and-in fan t-death .aspx [https://perma.cc/8na9-9t6n]. 177. press release, gov. gavin newsom, governor newsom signs ‘momnibus’ act to tackle racial disparities in maternal and infant health (oct. 4, 2021), https://www.gov.ca.gov/2021/10/ 04/governor-newsom-signs-momnibus-act-to-tackle-racial-disparities-in-maternal-and-infanthealth/ [https://perma.cc/569s-mtlv]. 178. s.b. 65, 2021 legis. sess. (cal. 2021). 179. id. 180. id. 378 indiana health law review [vol. 20:357 death.181 because the indiana mmrc is currently studying a small data set, which will likely remain the case for the next several years, analyzing smm cases will add value in understanding the circumstances and contextual factors that may not be available if the case reviews continue to be limited to solely deaths. further, obstetric experts recommend reviewing smm events to ensure safe obstetric care is being provided.182 moreover, the indiana mmrc entered into a collaborative relationship with the grassroots maternal child health leadership training project (“grassroots project”).183 the grassroots project’s purpose is to train community leaders in conducting survivor interviews to gain qualitative insights from the families, friends, and communities of women who suffered from a pregnancy-associated or pregnancy-related death.184 the mmrc highlighted lessons from the fetal infant mortality review process that includes interviewing families who suffered infant losses, to gain valuable insights into the families’ interactions with health care providers leading up to and including the death of their baby.185 recognizing that the perspectives of family and friends is important for enriching the data and circumstances leading up to an infant or maternal death would also be useful in smm cases. women who have experienced near death events during pregnancy, delivery, or the postpartum period may provide valuable qualitative insight related to their interactions with health care providers leading up to the event. these perspectives are integral to understanding the full context of smm events. b. indiana should fund doula and home visiting services next, the indiana general assembly seemed as if it was beginning to prioritize maternal health when it enacted a statute to provide doula services to low-income hoosier women. instead, lawmakers removed $20,000 in appropriated funds toward doula services on the final days of the 2019 legislative session making the effort void.186 doula care is a promising intervention for combating poor birth outcomes for low-income women and women of color, as doulas are well positioned to provide individual, patient-centered care that is culturally appropriate.187 doula services not only improve birth outcomes for mothers, but they also support healthy infant outcomes such as increased breastfeeding initiation rates and fewer low birth weight infants.188 given the numerous benefits, it is troubling that the indiana general assembly felt it was important enough to codify doula service coverage for medicaid recipients, but 181. kramer et al., supra note 42. 182. see kilpatrick & ecker, supra note 66. 183. ind. dep’t. health, supra note 6, at 51. 184. id. 185. id. 186. sheridan, supra note 118. 187. doula medicaid project, nat’l health l. program, https://healthlaw.org/ doulamedicaidproject/ [https://perma.cc/gdh9-cgsx] (last visited mar. 20, 2023). 188. id. 2023] indiana’s efforts to reduce maternal mortality 379 not important enough to fund doula services.189 additionally, providing home visiting services to every eligible new mother is an important strategy to combat maternal mortality and morbidity. several states pay for home visiting programs with public and private funding streams, including indiana.190 currently, idoh and the department of child services receive federal dollars from the maternal, infant and early childhood home visiting grant to provide home visiting services in six indiana counties.191 further, indiana code section 16-46-14-2 provides funds to idoh under the protecting indiana’s newborns (“safety pin”) grant.192 the safety pin grant provides funds to evidence-based home visitation programs for at-risk pregnant women.193 while these grants undoubtedly provide critical home visitation services to vulnerable pregnant women, the funds are limited and leave other vulnerable families from receiving services. similar to michigan and california, utilizing medicaid funds to expand home visitation services is an important step that indiana should take. to be sure, financing home visitation programs with medicaid funds can be complex because of the range of services that different home visiting programs provide, coupled with medicaid program requirements.194 fortunately, medicaid provides multiple paths for states to finance home visiting services, including through the use of medicaid waivers or amendments to state plans.195 further, the mmrc found that several pregnancy-associated deaths occurred shortly after women were discharged from an inpatient substance use treatment facility.196 the indiana mmrc recommends that women who use substances are immediately connected to outpatient services.197 similarly, supporting pregnant women with social support services, such as home visitation, is an integral strategy to supporting women going through recovery because it adds an additional layer of support to families. c. indiana should require implicit bias training for all healthcare providers importantly, the indiana mmrc also recommends that standardized education regarding implicit bias is provided for clinicians.198 it is wellestablished that healthcare providers’ implicit biases are associated with lower189. ind. code § 12-15-5-7(a) (2021); see sheridan, supra note 118. 190. becky normile et al., medicaid financing of home visiting services for women, children, and their families, nat’l acad. state health pol’y 1, 9 ( 2017). 191. governor newsom signs ‘momnibus’ act, supra note 177. 192. ind. code § 16-46-14-2 (2021). 193. ind. code § 16-46-14-4(a)(4) (2021). 194. normile et al., supra note 190, at 2. 195. id. at 9. 196. bavis, supra note 2, at 49. 197. see id. 198. see id. at 10. 380 indiana health law review [vol. 20:357 quality patient-provider communication for patients in marginalized groups.199 further, it is well-established that the u.s. healthcare system has historically minimized the concerns of people of color and women.200 for example, a study reviewing audio recordings of healthcare encounters found that healthcare providers who tested higher on implicit bias measures were “more verbally dominant and used less-patient centered language with black patients.”201 accordingly, requiring clinicians to undergo regular implicit bias training is an important step for mitigating health inequities that exist for pregnant women of color and pregnant women who use substances. moreover, recent national attention has highlighted the critical importance of mitigating racial bias in healthcare, but discriminatory practices among people who use substances has received less attention.202 substance users are “often seen as criminals, poor employees, and lacking a moral compass”203 and this becomes especially important to understand in the context of pregnant women who use illicit substances.204 in fact, studies have shown that regardless of knowledge and experiences’, the majority of nurses report feeling anger toward pregnant women who use substances.205 providing staff with education about addictions, and recognizing their own feelings about addictions has been shown to decrease provider frustration, and in turn, improve care.206 further, when clinicians do not understand their own biases, they are more likely to make unconscious assumptions about their patients and their patients’ needs that can lead to inappropriate treatment and misdiagnosis.207 accordingly, indiana should adopt a similar law as michigan’s administrative rule requiring that health care providers receive implicit bias training as a condition to receiving or renewing a health care license. this is a straightforward strategy to ensure the standardized education that the indiana mmrc recommends. the indiana general assembly is arguably obligated to enact such policy, yet 199. nao hagiwara et al., a call for grounding implicit bias training in clinical and translational frameworks, 395 lancet 1457, 1457 (2020). see also sun et al., supra note 57. 200. shanoor seervai, health care has a bias problem: here’s how to fix it, commonwealth fund (nov. 16, 2019), https://www.commonwealthfund.org/publications/ podcast/2019/nov/health-care-has-bias-problem-heres-how-fix-it?gclid=cjwkcajwzaslbhb jeiwajsrokn4tqr9upiuc4ufhgx3a8trxycgwyatstyycmrkavtwmrkcuv4dbuboc7eeq avd_bwe [https://perma.cc/k9fl-xqa9]. 201. sun et al., supra note 57. 202. see dara seybold et al., evaluation of a training to reduce provider bias toward patients with substance abuse, 14 j. soc. work prac. addictions 1, 3 (2015). 203. zara greenbaum, the stigma that undermines care, am. psych. ass’n. (june 2019), https://www.apa.org/monitor/2019/06/cover-opioids-stigma [https://perma.cc/ur6n-wl8f]. 204. see seybold et al., supra note 202. 205. id. 206. id. 207. mary kate brogan, addressing racial bias in health care a ‘life or death’ matter, va. commonwealth univ. health (jan. 11, 2021), https://www.vcuhealth.org/news/addressingracial-bias-in-health-care-a-life-or-death-matter [https://perma.cc/sjf5-3ger]. 2023] indiana’s efforts to reduce maternal mortality 381 it seems unlikely that it would pass, given the legislature’s recent push to enact a policy in public education that is nearly the complete opposite. during the 2022 legislative session, republican lawmakers introduced house bill 1134, attempting to ban “divisive concepts” by limiting what teachers could speak about in their classrooms including race, sex, and religion.208 specifically, the bill was inspired by opposition to “critical race theory” and aimed to give parents more power to oppose material they found inappropriate.209 the bill was highly controversial and ultimately died in the senate, but not before drawing criticism from the indiana state teachers association and the black community.210 notably, critics were concerned that the bill would prevent children from receiving an honest education.211 undoubtedly education and healthcare are separate issues, but the republican lawmakers tenacity towards passing a bill that would stifle teaching accurate racial history is indicative of whether the legislature would pass a law requiring implicit bias training for healthcare providers.212 in the likely event the general assembly refuses to act, hospitals and other healthcare facilities are well-suited to fill this gap by implementing implicit bias training for employees. because racism and bias are antithetical to the oaths and ethical responsibilities that healthcare professionals hold, it follows that organizations employing and training healthcare providers are well-positioned to develop and implement specific, concrete strategies to combat and raise awareness of biases held by their employees.213 importantly, before healthcare organizations invest time and financial resources in implicit bias training, they should critically evaluate the type of training they select.214 meaning, to truly move the needle and mitigate bias, healthcare organizations must commit to providing more than “box-checking training activities that result in no improvement in antiracism competencies or in institutional measures of inclusion, equity, or health outcomes.”215 this will require implementing a range of strategies such as aligning antiracism training with the organization’s mission and values, identifying institutional leaders and staff to oversee and direct trainings, developing a longitudinal antiracism training curriculum, and developing external 208. arika herron, indiana senate kills crt-inspired legislation that created outrage among educators, black hoosiers, indy star (feb. 28, 2022), https://www.indystar.com/story/ news/education/2022/02/28/hb-1134-indiana-senate-kills-crt-critical-race-theory-inspiredlegislation/9323738002/ [https://perma.cc/d5fr-qsuv]; see h.b. 1134, 123rd gen. assemb., reg. sess. (ind. 2022). 209. herron, supra note 208. 210. id. 211. id. 212. see id. 213. alicia d.h. monroe et al., antiracism training in medicine, jama health f. (dec. 3, 2020), https://jamanetwork.com/journals/jama-health-forum/fullarticle/2773845 [https://perma. cc/ey5e-ut8e]. 214. hagiwara et al., supra note 199, at 2. 215. monroe et al., supra note 213. 382 indiana health law review [vol. 20:357 partnerships to build trust with vulnerable populations.216 d. indiana should create a perinatal data warehouse finally, the indiana mmrc recommends that indiana promotes a statewide information exchange among indiana providers and agencies.217 through the indiana’s mmrc case review, it became clear that a woman’s outcome may have been different if health care providers from different organizations and agencies were able and willing to communicate with each other regarding the woman’s personal and health history.218 indiana is well-positioned to partner with an already existing and reputable health information exchange that exists in indiana— the indiana health information exchange (“ihie”). ihie has existed for over a decade and enables hospitals, doctors, labs and other health care service providers to deliver efficient and quality health care.219 ihie achieves this by promoting interoperability between electronic health records (“ehrs”), holding a large inter-organizational data repository, and maintaining a platform that supports population health efforts.220 partnering with ihie can potentially serve several purposes. first, it can eliminate the barriers to inter-provider communication that the mmrc highlighted such as disjointed ehrs, fragmented data sharing between state agencies and local health care providers, and hipaa limitations.221 second, multiple health systems participate in ihie across indiana, creating an already strong foundation for inter-provider communication that can be readily built on.222 finally, partnering with ihie provides an opportunity for indiana to create an innovative perinatal data warehouse similar to new york and california, where health officials can track maternal mortality, smm, and other maternal health indicators in real time. vi. conclusion because of the complexity of factors that contribute to maternal mortality, a multifaceted approach and sustained effort will be required to reduce the prevalence. while indiana has made necessary progress in implementing policies to reduce maternal mortality, these policies alone are insufficient. indiana has an unacceptable rate of maternal mortality. the indiana mmrc is undoubtedly doing critical work to study, evaluate, and make recommendations to prevent 216. id. 217. ind. dep’t. health, supra note 6, at 41. 218. id. 219. about us, ind. health info. exch., https://www.ihie.org/about-us/ [https://perma. cc/a933-lc6j] (last visited oct. 15, 2021). 220. id. 221. ind. dep’t. health, supra note 6, at 42. hipaa is a federal law that requires standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. 222. see careweb facilities list, ind. health info. exch. (jan. 2020), https://www.ihie.org/ wp-content/uploads/2020/01/careweb-facility-list.pdf [https://perma.cc/42wk-24x4]. 2023] indiana’s efforts to reduce maternal mortality 383 maternal deaths and improve indiana’s maternal mortality rates, yet it is unlikely that indiana will see improvements without more state legislative support. moving the needle to improve indiana’s maternal mortality requires more than the indiana general assembly codifying another committee or commission, such as the indiana mmrc, that focuses on women’s health. it requires implementing policies that are proving to reduce maternal deaths and appropriating the necessary funds. indiana has the opportunity to improve from its position as the third worst state for maternal mortality, but it will require the indiana general assembly to find the political will to enact policies that are recommended by its own mmrc and also working in other states. every hoosier woman deserves to have a healthy and safe outcome during pregnancy, delivery, and the postpartum period, and no family should lose a mother for reasons that are largely preventable. defying the odds: how indiana schools should implement multisystemic therapy to reduce the rate of juvenile incarceration for children with oppositional defiant disorder indiana health law review volume xxi 2024 number 2 notes defying the odds: how indiana schools should implement multisystemic therapy to reduce the rate of juvenile incarceration for children with oppositional defiant disorder madison steele * i. abstract under indiana code section 20-35-4-1.5, schools have a duty to educate students with a disability. 1 however, due to ineffective disciplinary measures in schools, students with debilitating behavioral health disorders are not receiving the education they are due. this note will explore why indiana should adopt legislation like new york’s ‘timothy’s law’ to allow for insurance coverage of multisystemic therapy to be implemented in schools as an alternative to other disciplinary actions for students diagnosed with disruptive behavioral disorders, and in particular, oppositional defiant disorder (odd). specifically, this note will begin with a hypothetical scenario of a young child diagnosed with odd who did not receive proper treatment of his disorder. this note will then outline what odd is, its history, and discuss how it is currently treated. next, this note will outline how schools are affected by oppositional defiant disorder and how this directly contributes to juvenile incarceration rates. this note will then propose a solution to juvenile incarceration rates of children with odd by proposing that schools implement multisystemic therapy programs, modeled after a californian logic model. during this proposal, this note will discuss what multisystemic therapy is and how it would look in a school setting. this note will further outline the cost of implementing the program and analyze how indiana legislation currently has passed some legislation that can off-set the cost of the program. finally, this note will recommend further legislative changes like new york’s “timothy law” that will allow for insurance coverage of the therapy. ————————————————————————————— * j.d. candidate 2024, indiana university robert h. mckinney school of law. b.a. law and justice 2021, auburn university. the author extends her gratitude to professor cynthia baker and professor jonathan warner for their mentorship and guidance during the note writing process. the author also thanks the editorial staff of the indiana health law review for their diligence in publishing this note. 1. ind. code § 20-35-4-1.5. indiana health law review [vol. 21:387 388 a. john’s story john carter, of benton county, indiana, was diagnosed at age eight with oppositional defiant disorder (odd). 2 over the past year, during school and at home, john would experience frequent patterns of angry and irritable moods, argumentative and defiant behavior, and vindictiveness. doctors described oppositional defiant disorder to john’s parents as a disruptive behavioral disorder in which children show frequent patterns of defiant acts, which appear typically in the presence of adults and authority figures. after diagnosis, john’s parents were referred to the nearest children’s hospital that specialized in behavioral health treatment to set up an appointment. the following week, john carter and his family made the hour and forty-five-minute journey to indianapolis for their first of many weekly treatment sessions. traveling to these therapy sessions required john to miss entire days of school and caused john’s parents to take off work due to the distance needed to travel for treatment. missing school often caused john to fall behind in his courses. over the course of the next five-years, physicians tried several therapies and treatments to address john’s behavioral issues including behavioral therapy, therapies targeted towards parent-child interaction, and medication. behavioral therapy was targeted towards john’s odd diagnosis because of the impulsive behaviors associated with the disorder. doctors believed that if john learned how to control these impulses, he would be less likely to act defiantly in the presence of others. however, when john’s behavioral issues persisted, doctors adjusted his therapy to be modeled around parent-child interactions. this therapy involved the therapist watching from an observation room with a one-way mirror or live video feed. during this therapy, john and his mother would interact with each other in a playroom while his mother was wearing an earpiece. through the earpiece, the therapist would provide realtime coaching on skills to manage john’s behavior. one afternoon, while the carter family was in this interaction therapy, john was instructed by his mother to pick up the toys around the playroom. john refused and after several failed attempts to redirect his behavior, john’s mother was instructed to leave the room by the therapist. his mother entered the observation room with the therapist and watched as john continued to play with the toys scattered around the room. when john realized his mother would not be returning to the room, his behavioral issues worsened and he began to make a larger mess in the playroom, scattering toys and tipping over furniture. the therapist instructed john’s mother to wait in the observation room, under the suspicion that if his negative behavior were not acknowledged, he would cease his destructive conduct. eventually, john threw a chair at the one-way mirror ————————————————————————————— 2. john carter is a fictional subject inspired by the author’s personal experience with oppositional defiant disorder and juvenile delinquency. his story is used to discuss the implications of the disorder and the effects that it can have on a child if not properly treated. 2024] defying the odds 389 where he knew his mother and the therapist were observing. concerned for his safety and the safety of others, the physician recommended that john be committed to the children’s psychiatric ward at the hospital they were at. following his in-patient care, john’s parents felt that treatment at the children’s hospital was not effectively addressing john’s disorder. while he was making progress in his behavior at home, at school john received more negative marks for his behavior on the days following a trip to his therapy than he did leading up to the appointment. his parents feared that his missing school, and effectively falling behind in his lessons and not understanding the material, was causing him to act out even more. when they discussed alternative treatment with the physicians, they prescribed john medication to reduce the symptoms of his oppositional defiance disorder. the carter family was advised that they may have to try several medicines to find one that works for john. john continued to act out in school, resulting in the principal sending him to the local alternative school. there he met two seventeen-year-old boys who lived in his neighborhood. when he returned from his alternative school placement, john’s behavior persisted, resulting in several out-of-school placements through suspension. during these suspensions, john would be left home alone while his parents went to work. he would frequently meet up with the older boys in his neighborhood and engage in delinquent behavior such as committing curfew violations, underaged drinking, and illegally shooting fireworks. one night, john and the two seventeen-year-old boys broke into the home of carter’s sixty-two-year-old neighbor, susan vance, while wearing bright orange ski masks. vance, upon hearing the commotion, walked downstairs and found the boys rummaging through a closet under the staircase. carter, who was standing nearest to the base of the stairwell, saw vance approach and pulled out a plastic pistol that was spray-painted black to look more realistic. believing that the gun in carter’s hand was real, vance attempted to run upstairs where her phone was charging in her bedroom. carter caught her by the arm and pulled her towards the other boys. the boys then threatened vance and ordered her to show them where any cash was hidden. vance directed the boys toward a vintage, sewing kit box where $200 cash was hidden inside. the boys took the money and left the home. they were arrested the next day after police found a ski mask, matching the description given by vance, hanging on a fence post separating vance and carter’s homes. john carter was fourteen years old when he was convicted of armed robbery and sentenced to seven years in a juvenile detention center. 3 children, like john carter, who suffer from behavioral disorders, like oppositional defiant disorder, are at an increased risk of being incarcerated in ————————————————————————————— 3. juveniles, of similar age to carter, have been charged as adults for crimes like those in this example scenario; see, e.g., mcguire v. lee, 239 ariz. 384 (ariz. ct. app. 2016). indiana health law review [vol. 21:387 390 their youth.4 these youths are of younger ages at the time of the first arrest and have an increased risk of recidivism compared to children of similar ages without disruptive behavior disorders. 5 of committed youth, nationally, 94.9% appeared to have significant symptoms of attention deficit hyperactivity disorder, conduct disorder, oppositional defiant disorder, or substance use disorder. 6 ii. what is oppositional defiant disorder (odd)? oppositional defiant disorder is a disruptive behavioral disorder in which children show frequent patterns of defiant acts. 7 these uncooperative behaviors appear typically in the presence of adults and authority figures. 8 symptoms of oppositional defiant disorder include a pattern of angry/irritable mood, argumentative and defiant behavior, and vindictiveness lasting at least six months. 9 children with odd will often lose their temper; be easily annoyed, are often angry or resentful; will often argue with authority figures; actively defy or refuse to comply with request from authority figures; deliberately annoy others; and have a pattern of being spiteful or vindictive. 10 like other children with oppositional defiant disorder, the symptoms that john was experiencing can be seen in many children and teens, however children with odd express these behaviors on a frequent basis and with more hostility than peers of their age. 11 there is no known cause of oppositional defiant disorder, but some physicians and researchers believe it can be linked to genetics and a child’s environment (i.e. lack of supervision, inconsistent or harsh discipline, or abuse or neglect). 12 without proper treatment, children, like john, will continue to lose their temper, argue with authority figures, and actively defy and refuse to comply with request from authority figures. 13 these continued behaviors can lead to an increased risk for a number of problems including antisocial behavior, ————————————————————————————— 4. marjorine castillo, disruptive behavior disorders in childhood and criminal justice system involvement in adolescence and emerging adulthood: pilot results among puerto rican youth (2016) (m.a. psychology dissertation and thesis, hunter college cuny) (on file with hunter college cuny’s theses and dissertation collection). 5. id. 6. valerie slater, juvenile justice, 56 u. rich. l. rev. 107, 122 (2021). 7. oppositional defiance disorder, nationwide child.’s hosp., https://www.nationwide childrens.org/conditions/oppositional-defiant-disorder [https://perma.cc/4npr-8vem] (last visited sept. 5, 2022). 8. id. 9. am. psychiatric ass’n, diagnostic and statistical manual of mental disorders 462 (5th ed. 2013). 10. id. 11. oppositional defiance disorder, supra note 7. 12. oppositional defiant disorder, mayo clinic, https://www.mayoclinic.org/diseasesconditions/oppositional-defiant-disorder/symptoms-causes/syc-20375831 [https://perma.cc/m2u2-8scv] (last visited oct. 16, 2022). 13. am. psychiatric ass’n, supra note 9. these are only a fraction of symptoms experienced by children with oppositional defiant disorder. https://perma.cc/m2u2-8scv https://www.mayoclinic.org/diseases https://perma.cc/4npr-8vem https://childrens.org/conditions/oppositional-defiant-disorder https://www.nationwide 2024] defying the odds 391 impulse-control problems, substance abuse, anxiety, and depression. 14 when oppositional defiant disorder is not properly addressed, children with the disorder will experience frequent conflicts with parents, teachers, supervisors, and peers. 15 these problems lead to impairments in the child’s present and future emotional, social, academic and occupational development. a. history of odd as a declared mental disorder oppositional defiant disorder was first introduced into the second edition of the american psychiatric association’s diagnostic and statistical manual of mental disorders (dsm). 16 it was not listed as an official disorder until the publication of the third edition of the dsm in 1980. 17 with this designation, there were questions as to the validity of the disorder. many criticized that odd was just unruly behavior, and others argued that the disorder was just a mild form of a conduct disorder. 18 revisions were made to the dsm in 1987 and 1994 to answer these questions and distinguish odd from conduct disorder. 19 the 1987 revision clarified that odd is separate from conduct disorder because its symptoms are considered to be less aggressive. 20 the published research at the time even suggested that odd could be a pre-curser to conduct disorder in extreme cases. 21 because of this research, and clarifications, odd has now become widely accepted as a disorder but there is still confusion about the frequency and severity of the disorder, especially because the symptoms can lead to incomplete diagnosis through comorbid disorders or through differential diagnosis.22 for example, attention deficit hyperactivity disorder (adhd) frequently overlaps with “externalizing disorders” such as odd. 23 with both disorders, children may resist work or school task that require self-application. 24 in adhd the children resist work or school task that require self-application due to their inability to keep focus on assignment. 25 however, children with odd resist work because they resist conforming to others demands. 26 rates of odd are found more frequently in children with adhd, which is theorized to be the ————————————————————————————— 14. id. at 464. 15. id. at 465. 16. dustin a. pardini, et. al, building an evidence base for dsm-5 conceptualizations of oppositional defiant disorder and conduct order: introduction to the special section, 119 nat’l libr. med. 683-88 (2010), [https://perma.cc/9by9-xxef]. 17. id. 18. id. 19. id. 20. id. 21. id. 22. id. 23. dsm-v, supra note 9, at 65. 24. id. at 63. 25. id. 26. id. https://perma.cc/9by9-xxef indiana health law review [vol. 21:387 392 result of temperamental risk factors. 27 additionally, children with odd are at increased risk for diagnosis of anxiety disorders and major depressive disorders. 28 these diagnoses are attributable to the presence of the angry and irritable moods. 29 with the publication of the dsm-v, the fifth edition of the manual, came several updates to the diagnosis of odd. 30 symptoms of the disorder were grouped into three major categories: vindictiveness, angry/irritable moods, and argumentative behavior. 31 these groupings were used to emphasize that the disorder is both behavioral and emotional. 32 information on the frequency of the symptomatic behaviors was also added to the newest edition of the dsm. 33 this information is useful for physicians tasked with diagnosing the disorder because it allows them to differentiate between poor, but normal, childhood behavior and behavior caused by odd. the final update with the dsm-v was a new severity category that allows physicians to analyze the disorder across different settings to determine how the disorder is affecting the child’s life.34 there are three levels of severity that physicians use to diagnose odd. 35 a mild diagnosis is given when symptoms are confined only to one setting (e.g. at home, at school, at work, or with peers). 36 a diagnoses of moderate oppositional defiant disorder shows that symptoms of the behavior present themselves in at least two settings (e.g. both at home and in school). when a child is diagnosed with a severe case of odd, they are exhibiting symptoms in three or more settings. john carter’s diagnosis would be appropriate under this severe category. b. current medical based treatments of odd early diagnosis by a trained child psychologist or psychiatrist is crucial to treat the disorder and prevent future problems. 37 popular treatment for oppositional defiant disorder includes cognitive-behavioral therapy, family therapy, and medicines to treat comorbid disorders such as adhd which exacerbate the symptoms of the disorder. 38 ————————————————————————————— 27. id. 28. id. at 462. 29. id. 30. pardini et al, supra note 16. 31. id. 32.id. 33. id. 34. id. 35. dsm-v, supra note 9, at 462-63. 36. id. 37. oppositional deviance disorder (odd) in children, john hopkins med., https://www. hopkinsmedicine.org/health/conditions-and-diseases/oppositional-defiant-disorder [https:// perma.cc/q3nk-6u6u] (last visited sept. 5, 2022). 38. id. https://hopkinsmedicine.org/health/conditions-and-diseases/oppositional-defiant-disorder https://www 2024] defying the odds 393 1. cognitive behavioral therapy cognitive behavioral therapy is a form of therapy that looks to identify and change potentially self-destructive or unhealthy behaviors. 39 cognitive behavioral therapy is centered around how one’s thoughts and beliefs influence one’s actions and moods. 40 it focuses on current problems and how to solve them. 41 the long-term goal is to build thinking and behavioral patterns that helps the patient achieve a better quality of life. 42 this therapy was targeted towards, the hypothetical, john carter’s odd diagnosis because of the impulsive behaviors associated with the disorder. doctors believed that if john learned how to control these impulses, he would be less likely to act defiantly in the presence of others. cognitive behavioral therapy may be one of the most productive treatments towards odd available to patients. some critics of cognitive behavioral therapy believe that because it only addresses current problems and focuses on specific issues, the underlying cause of mental health conditions are not addressed. 43 cognitive behavioral therapy only focuses on the individual’s ability to change themselves through their thoughts, feelings, and behaviors. it does not look at wider problems in the child’s environment like their families or peers that may have a significant impact on their health and wellbeing. 44 other therapies may help bridge this gap between a child’s internal issues and their environment. multisystemic therapy, for example, would do this by targeting the child’s school, home, and community environments and the interactions held within those environments. 2. parent-child interaction therapy parent-child interaction therapy is a behavioral therapy that is conducted through coaching sessions that navigate parent-child interactions. 45 this therapy involves the therapist watching from an observation room with a one-way mirror or live video feed. 46 during this therapy, a parent and child will interact with each other in a play room while the parent is wearing an earpiece, where the therapist will provide real time coaching on skills to manage a child’s ————————————————————————————— 39. ana gotter & molly burford, behavioral therapy, healthline, https://www.healthline. com/health/behavioral-therapy#who-benefits [https://perma.cc/xj82-a3q2] (mar. 17, 2022). 40. id. 41. id. 42. id. 43. pros and cons of cbt therapy, the cbt clinic, http://www.thecbtclinic.com/proscons-of-cbt-therapy [https://perma.cc/fzw2-vjbf] (last visited mar. 26, 2023). 44. id. 45. what is parent-child interaction therapy (pcit)?, pcit international, www.pcit. org/what-is-pcit.html [https://pema.cc/kkpf4-bhvx] (last visited oct. 16, 2022). 46. id. https://pema.cc/kkpf4-bhvx https://perma.cc/fzw2-vjbf http://www.thecbtclinic.com/pros https://perma.cc/xj82-a3q2 https://www.healthline indiana health law review [vol. 21:387 394 behavior. 47 doctors attempted this therapy with john carter and his parents because some behavioral physicians and researchers believe odd can be caused by a child’s environment (i.e. “lack of supervision, inconsistent or harsh discipline, or abuse or neglect”). 48 parent-child interaction therapy is conducted in two phases. 49 first, the treatment focuses on establishing a warmer relationship between parent and child “through learning and applying skills that allow children to feel calm, secure in their relationships with their parents, and good about themselves.”50 the second phase of this therapy focuses on equipping the parent to manage their child’s behaviors while remaining calm, confident, and consistent in their approaches to discipline. 51 this therapy yields positive results towards reforming a child’s interaction with their parents and vice-versa. while this is productive in repairing the home environment, there is no guarantee that the behavioral therapy will translate into other environments of the child’s life (such as in school or in the community). an alternative therapy, like multisystemic therapy would focus on individual, family, peer, school, and community risk factors that contribute to concerning behaviors. through focusing on more than one environment of a child’s life, children can learn to transfer their learned behaviors into different areas of their day-to-day. 3. medication medication is usually only prescribed to children with disruptive behavioral disorders if “psychosocial treatment does not help enough.”52 “these medicines cannot cure disruptive behavioral disorders”, but they can be “used to reduce the symptoms and improve [a child’s] quality of life.”53 these medicines will work differently in different children and teens because of the way they change how certain chemicals act in the brain. 54 because of this, parents “may have to try several medicines to find one that works” for each child.55 this treatment for odd is helpful in reducing the symptoms of the disorder and may reduce the impulses to act out. however, the root of the issue is not being addressed. children’s behavioral problems are still present, even though they may not be as visual. multisystemic therapy would work to reduce delinquent behavior by improving cognitive responses to temperamental ————————————————————————————— 47. id. 48. mayo clinic, supra note 12. 49. pcit international, supra note 45. 50. id. 51. id. 52. treating disruptive behavior disorders in children and teens, agency for healthcare research and quality, https://effectivehealthcare.ahrg.gov/products/disruptivebehavior-disorder/consumer, [https://perma.cc/9ryj-ygud] (last visited oct. 16, 2022). 53. id. 54. id. 55. id. https://perma.cc/9ryj-ygud https://effectivehealthcare.ahrg.gov/products/disruptive 2024] defying the odds 395 triggers. iii. why should indiana focus on treating oppositional defiant disorder in schools? when students, like those with oppositional defiant disorder, consistently exhibit disruptive behavior, they are often disciplined by being removed from the classroom through suspension, detention, or other out of school placements like alternative schools. 56 detrimental discipline policies, such as removing students from school for disruptive behavior, contributes to the school-to-prison pipeline. the more a child is suspended, the less likely they are to complete or even return to school. 57 a child’s conduct, if not properly addressed, is likely to become more severe when they are not able to attend school, leading to out of home placements in residential facilities and similar juvenile detention centers. 58 by removing the child from school, via suspension or similar disciplinary measures, the root of the behavioral problems are not being addressed. a. history of the school to prison pipeline the “school-to-prison pipeline” represents a national trend where primarily youth of color, children with disabilities, and children with histories of poverty, abuse, or neglect are funneled out of public schools and into the juvenile and criminal legal systems. 59 prior to the gun-free schools act of 1994, keeping children out of school as a punishment was rare and fewer than 4% of students were suspended across the united states in 1973. 60 this act, signed into law by president bill clinton, encouraged states who received federal funding to implement “zero-tolerance policies” which required educational agencies to, at minimum, implement one-year expulsions upon any student that has brought a weapon to school. 61 additionally, schools were directed to refer these children to the criminal justice or juvenile delinquency system, or risk losing their federal funding.62 the rate of suspension drastically increased as schools began to interpret the term “weapon” broadly; leading to the suspension and expulsion of students ————————————————————————————— 56. amreen khan, multisystemic therapy can help slow the school-to-prison pipeline, mst services, https//www.mstservices.com/school-safety-resources (last visited oct. 16, 2022) [https://perma.cc/dd49-sraq]. 57. id. 58. id. 59. school-to prison pipeline, aclu, https://www.aclu.org/issues/juvenile-justice/juvenilejustice-school-prison-pipeline [https://perma.cc/4qxb-ejl9] (last visited oct. 16, 2022). 60. libby nelson & dara lind, the school-to-prison pipeline, explained: police officers in classrooms are just the tip of the iceberg, vox (oct. 27, 2015, 11:05 am), https://www. vox.com/2015/2/24/8101289/school-discipline-race [https://perma.cc/rw9z-vknl]. 61. gun-free school’s act, 20 u.s.c.a. § 7961 62. id. https://perma.cc/rw9z-vknl https://vox.com/2015/2/24/8101289/school-discipline-race https://www https://perma.cc/4qxb-ejl9 https://www.aclu.org/issues/juvenile-justice/juvenile https://perma.cc/dd49-sraq https://https//www.mstservices.com/school-safety-resources indiana health law review [vol. 21:387 396 who, for example, made handguns with their fingers, or chewed pop-tarts into the shape of a gun.63 around the same time as these zero-tolerance policies were being enacted, schools were also heavily disciplining small offenses to “make [students] feel safer and discourage more serious crimes.”64 this meant that bad behaviors such as talking back to teachers, skipping class, or being disobedient or disruptive, would lead to more suspensions and out-of-school placements.65 children with odd are likely to exhibit these behaviors, putting them at greater risk of heavy discipline under these strict policies. students who are suspended are more likely to repeat a grade, or drop out, than students who were not. 66 a texas study found that students who had been suspended or expelled were twice as likely to drop out compared to students with similar characteristics at similar schools who had not been suspended. 67 following the columbine massacre, 68 school administrators also began relying heavily on school resource officers (sros) being stationed at school. while there is no federal mandate requiring the use of sros, the national association of school resource officers estimated in 2018 that at least 42% of schools in the united states have at least one sro present at least one day a week during the academic year. 69 however, the resource officers who were designated for a specific occurrence, to prevent school shootings, were soon being used to manage misdemeanor and civil violations caused by students. 70 these officers patrol the schools, often with little to no training on how to work with youth. 71 this resulted in more school-based arrests, “the majority of which [were] for non-violent offenses, such as disruptive behavior.”72 prior to governor eric holcomb signing house bill 1093 into law in february of 2022, there were a large number of police officers working inside of indiana schools without specialty training on how to interact with children. 73 ————————————————————————————— 63. patrik jonsson, ohio boy suspended for pointing finger like a gun. ‘zero tolerance’ run amok?, the christian science monitor (mar. 4, 2014) https://www.csmonitor.com/usa/ education/2014/0304/ohio-boy-suspended-for-pointing-finger-like-a-gun.-zero-tolerance-runamok [https://perma.cc/zcp3-tuhy]. 64. libby nelson & dara ling, supra note 60. 65. id. 66. id. 67. id. 68. the 1999 school shooting and attempted bombing in columbine, colorado, that resulted in the death of twelve students and one teacher. see charles schaefer, columbine shooting, history (june 29, 2023), https://www.history.com/topics/1990s/columbine-high-schoolshootings [https://perma.cc/3aqz-ldtd]. 69. how many school resource officers are there in the united states?, nat’l ass’n of sch. res. officers, https://www.nasro.org/faq/ [https://perma.cc/4qfn-ua7l] (last visited jan. 23, 2024). 70. libby nelson & dara ling, supra note 60. 71. id. 72. aclu, supra note 59. 73. lee v. gaines, new law closes training loophole for police in indiana schools, wfyi indianapolis, https://www.wfyi.org/news/articles/holcomb-signs-law-training-loophole-policeindiana-schools [https://perma.cc/an2g-pnr9] (last visited, mar. 1, 2023). https://perma.cc/an2g-pnr9 https://www.wfyi.org/news/articles/holcomb-signs-law-training-loophole-police https://perma.cc/4qfn-ua7l https://www.nasro.org/faq https://perma.cc/3aqz-ldtd https://www.history.com/topics/1990s/columbine-high-school https://perma.cc/zcp3-tuhy https://www.csmonitor.com/usa 2024] defying the odds 397 previous legislation required that any officer who identified themselves as an sro was required to undergo an forty-hour sro training from the national association of school resource officers. 74 this training taught officers basic understandings “on adolescent brain development, how to interact with students with disabilities,” how to understand racial biases, and other subjects to improve officer-student interactions. 75 a loophole existed in previous legislation –– according to chase lyday, director of the indiana school resource officer association –– that police who worked inside of schools could avoid the required training by not identifying themselves as sros. 76 lyday reported that the state did not track how many officers in school had received the basic sro training, so there was no way to determine if police in schools were properly trained. 77 during the 2018–2019 academic year, 1,217 arrests occurred in schools across the state of indiana. 78 this total accounted for 1% of all students enrolled in public schools across the state. according to the 2020 indiana probation report, created in accordance with indiana code section 31-31-10-1 et seq., a total of 6,412 individuals ranging from ages six-to-eighteen were declared juvenile delinquents.79 house bill 1093 was designed to eliminate this loophole. the bill amends several sections of the indiana code concerning education and the responsibilities of school resource officers. 80 the bill defines an sro as “a law enforcement officer who has completed the [required] training . . ., [and] is assigned to one (1) or more school corporations or charter schools during school hours.”81 through this new definition, the previous loophole has been eliminated because officers do not have to identify themselves as sros in order to require the training, they need only to be assigned to a school corporation during school hours. the law also specifies that officers must receive the required forty-hours of training within one-hundred-eighty days from the date the officer is assigned as an sro. 82 the law, as amended, opens “law enforcement agencies to potential legal action” when an sro is found to have not completed the training, or violated the duties of their role. 83 ————————————————————————————— 74. id. 75. id. 76. id. 77. id. 78. stephanie wang & dylan peers mccoy, why are school police twice as likely to arrest black students in indiana than white students?, chalkbeat indiana, https://in.chalkbeat. org/2020/6/24/21301860/indiana-black-students-arrested-2-5-rate-of-white-peers [https://perma. cc/7hlu-fgmd] (last visited, oct. 16, 2022). 79. probation department of the juvenile court, 2020 indiana probation report: summary and statistics, 25, https://www.in.gov/courts/iocs/files/rpts-ijs-2020-probation.pdf [https://perma.cc/64ys-kuw9] (last visited june 17, 2024). 80. h.b. 1093 (in. 2022). 81. id. 82. id.; the training requirement may be extended to up to a year if the assigned school has a student population of less than one thousand. 83. lee v. gains, supra note 73. https://perma.cc/64ys-kuw9 https://www.in.gov/courts/iocs/files/rpts-ijs-2020-probation.pdf https://perma https://in.chalkbeat indiana health law review [vol. 21:387 398 this amended law is a critical step towards reforming how schools, and sros, manage juvenile misconduct; however, children are still at risk of juvenile detention with these changes. when a school permits an sro to arrest a student, they are turning the student over to the juvenile justice system, making it easier for a student to gain a juvenile record. 84 for districts with disciplinary alternative schools, children who are removed from their regular schools are often sent to alternative schools that are not regulated by educational accountability standards, like curriculum requirements and minimum classroom hours. 85 this means that children already struggling from out-of-school placements are returning to the classroom unprepared. 86 students in districts without alternative schools, or students who are funneled through alternative schools into the juvenile justice system, are often denied procedural protection in court.87 up to 80% of court-involved children do not have lawyers. 88 children put on probation within the juvenile justice system may end up in out-of-home placements for minor probation violations like missing school or disobeying teachers. 89 in 2022, indiana was still incarcerating juveniles at a rate that is around 40% higher than the national average. 90 around 55% of indiana children and teens who were detained in 2022, prior to a court decision, were accused of misdemeanors like theft or possession of marijuana. 91 about 5% of the youth in indiana who were detained prior to trial, in 2022, were accused of offenses that are only illegal because of their age, such as running away or missing school.92 students who end up in out-of-home placements like juvenile detention facilities are provided with few, if any, educational services. 93 these delays make it harder for the impacted children to finish school, leading to higher chances of delinquency and recidivism as an adult. b. juvenile incarceration and its long-term effects during a recent study conducted by the marshall project, keri blakinger and maurice chammah interviewed over a dozen cases of death row prisoners who previously spent time in juvenile detention centers. 94 throughout the study, ————————————————————————————— 84. libby nelson & dara ling, supra note 60. 85. aclu, supra note 59. 86. id. 87. id. 88. id. 89. id. 90. dylan peers mccoy & katrina pross, why indiana locks up more children and teens than new york, wfyi (nov. 16, 2022), https://www.wfyi.org/news/articles/indiana-detainscommits-at-a-rate-40-above-the-national-average [https://perma.cc/3j7k-fph6]. 91. id. 92. id. 93. aclu, supra note 59. 94. keri blakinger & maurice chammah, they went to prison as kids. now they’re on death row: fight clubs, solitary confinement and neglect make juveniles angrier and more https://perma.cc/3j7k-fph6 https://www.wfyi.org/news/articles/indiana-detains 2024] defying the odds 399 the marshall project noted the history of policing and detaining youth and how it often leads to angrier and more violent behavior than when the juveniles entered the facilities. 95 as early as 1830, the united states implemented the first “reform school” which aimed to “rehabilitate troubled city kids through communion with nature.”96 these “schools” eventually evolved to work farms where children were violently abused. 97 in the 20th century, states began sending “juvenile delinquents” to youth prisons. 98 in states, like texas, kids were reporting abuses that could only be described as “exotic torture.”99 in the class action suit of ruiz v. estelle, eight inmates sued texas department of corrections alleging that present conditions of their incarceration (including overcrowding, lack of access to health care, and abusive security practices) were a violation of their constitutional rights under the eighth amendment.100 the united states district court for the southern district of texas found that the conditions of the texas department of corrections prisons constituted cruel and unusual punishment in violation of the eighth amendment of the united states constitution. 101 after ruiz a nationwide trend began to move away from incarceration and into moving “delinquent children” into group homes that emphasized treatment. 102 soon after the movement came into effect, the war on drugs began. 103 this created fear, across the country, of teenage “super predators” which led to an influx of juvenile incarceration. 104 researchers found that incarceration, both in juveniles and adults, leads to increased recidivism rates. 105 researchers found that people incarcerated during their youth were less likely to finish high school and more likely to be incarcerated as adults. 106 juan ramirez, another inmate on death row, tried to escape gang involvement as a teenager but was eventually sent to a juvenile detention center “dominated by gang violence.”107 michele deitch, a professor at the university of texas, wrote a defense affidavit on behalf of mr. ramirez. 108 in the affidavit, she noted that “the punitive treatment of youth confirms their self-identity as ————————————————————————————— violent, the marshall project (feb. 1, 2022), https://www.themarshallproject.org/ 2022/02/01/they-went-to-prison-as-kids-now-they-re-on-death-row [https://perma.cc/u3mtr6n9]. 95. id. 96. id. 97. id. 98. id. 99. id. 100. see generally, ruiz v. estelle, 503 f. supp. 1265 (s.d. tex. 1980). 101. id. 102. plakinger & chammah, supra note 94. 103. id. 104. id. 105. id. 106. mccoy & pross, supra note 90. 107. blakinger & chammah, supra note 94. 108. id. https://perma.cc/u3mt https://www.themarshallproject.org indiana health law review [vol. 21:387 400 criminals and increases their anger, trauma, and reliance on physical force.”109 in indiana, virsarah davis’s son was “held in juvenile detention so many times, the reasons blur together in her memory,” starting with the first detention at only ten-years-old. 110 following the initial detainment, davis’s son was inand-out of detention for the next eight years. 111 she noted that every time he came home, he became less like himself and acted more like he was still in detention.112 executive director of the children’s policy and law initiative of indiana noted that “the justice system imposes its own trauma. . . [a]nytime you take a child into a locked situation, you’re going to be imposing, potentially, more harm.”113 juvenile incarceration facilities are continuing to fail to address the root causes of the problems that led to incarceration in the first place. it is important that children receive adequate care and support to prevent both the initial incarceration, and to reduce the rate of recidivism for those who have already become victims of mass incarceration. there is robust evidence that multisystemic therapy reduces the likelihood of incarceration and recidivism for juveniles more than other treatments. 114 iv. multi-systemic therapy as an alternative to disciplinary action in the indiana behavioral health commission’s september 2022 report, the commission reported that members unanimously agreed that the intersection between criminal incarceration and individuals with behavioral health issues is a priority area that needs to be addressed. 115 their report found that 37% of people in state and federal prisons, and 44% of people in jail have been diagnosed with a mental illness. 116 multisystemic therapy (mst) is an intensive family and community-based treatment for at-risked youth.117 the goal of mst is to decrease criminal behavior in juveniles and reduce “out-of-home” placements. 118 mst treatments ————————————————————————————— 109. id. 110. mccoy & pross, supra note 90. 111. id. 112. id. 113. id. 114. multisystemic therapy (mst) for juvenile offenders, county health rankings, https://www.countyhealthrankings.org/take-action-to-improve-health/what-works-for-health/ strategies/multisystemic-therapy-mst-for-juvenile-offenders [https://perma.cc/q7s3-xjhm] (last visited mar. 23, 2023). 115. indiana behavioral health commission, final report 27 (2022), https://www. in.gov/fssa/dmha/files/inbhc-report.pdf [https://perma.cc/t5rn-swlm]. 116. id. 117. county health rankings, supra note 114. 118. california evidence-based clearinghouse for child welfare, multisystemic therapy program guide (2009), https://www.cebc4cw.org/program/multisystemic-therapy/ detailed [https://perma.cc/xdl4-xzpa]. https://perma.cc/xdl4-xzpa https://www.cebc4cw.org/program/multisystemic-therapy https://perma.cc/t5rn-swlm https://in.gov/fssa/dmha/files/inbhc-report.pdf https://www https://perma.cc/q7s3-xjhm https://www.countyhealthrankings.org/take-action-to-improve-health/what-works-for-health 2024] defying the odds 401 include several key features like: (a) integration of treatment approaches aimed to address risk factors across family, peer, school, and community contexts; (b) promotion of behavior changes in children’s natural environment and to empower caregivers; and (c) implementing assurance mechanisms that focus on maintaining treatment fidelity and which overcome barriers of the intended behavior change. 119 this treatment, unlike other mental health treatments that focuses on one core issue, works to both reshape behavioral responses as well as rebuilding relationships within a child’s environment.120 the program targets all influences of a child’s ecology. the california evidence-based clearinghouse for child welfare created a multisystemic therapy program guide outlining the program, required training, and implementation. the program’s key components include improving family functioning, and intervention into peer, school, and community ecology. 121 these interventions improve family functioning; decreases association with negative peers; improves school behavior, attendance, and performance; improves family connections with informal supports, community resources, and formal systems; and increases prosocial attitudes and skills within the individual which reduces other individually based problems for children. 122 each therapist carries a maximum caseload of six families and each case length would range from three-to-five months.123 the expected beneficial outcomes of the program include a reduced rate of incarceration and recidivism for at-risk youth.124 other potential benefits include reduced delinquent behaviors, reduced risk of substance abuse disorders, improved family and community interactions, improved mental health, and reduced foster care use. 125 a. what would multisystemic therapy look like in schools? according to california’s program guide, service intensity would vary slightly with the needs of the student in the program. 126 early in the treatment, the therapist may meet with the student several times per week, but as treatment progresses the intensity tapers. 127 the recommended duration of the multisystemic therapy is typically between three-to-five months. 128 during this ————————————————————————————— 119. id. 120. id. 121. scott henggeler et. al, multisystemic therapy logic model, evidence-based prevention & intervention support ctr. at penn st. univ., https://www.episcenter. psu.edu/sites/default/files/202006/mst%20logic%20model%20rev%202015.pdf [https://perma.cc/6ty4-863p] (last revised feb. 2015). 122. id. 123. california evidence based clearinghouse for child welfare, supra note 118. 124. county health rankings, supra note 114. 125. id. 126. henggeler et. al, supra note 121. 127. california evidence based clearinghouse for child welfare, supra note 118. 128. id. https://perma.cc/6ty4-863p https://www.episcenter indiana health law review [vol. 21:387 402 time a mst therapist will meet with the caregiver, family, and/or youth, as well as others in the child’s life. services are delivered in home, school, and community, at times convenient for the family. 129 specific strategies and techniques will then be selected and tailored after careful assessment of the factors driving the problem behavior. 130 interventions are then closely monitored for effectiveness and modified as needed. 131 mst would include a homework component, which may be assigned in relation to parent management training, treatment for anger management, treatment for caregiver or youth substance abuse, or for family communication training. 132 mst therapists will then target decreasing risk factors that increase the likelihood of negative outcomes, such as drug use, delinquency, school dropouts, violent behavior, and incarceration. 133 they will also target increasing protective factors that exert positive influence, such as engagement in prosocial activities in school and community, commitment to schooling, problem-solving skills, and more that buffer against negative outcomes. 134 during this time, a child should be given their own individualized education plan (iep) to be used as the therapy is being implemented. ieps serve as a “map that lays out the program of special education instruction, supports, and services kids need to make progress and thrive in school.”135 these individualized educations should give students extra help and support in the classroom while they are completing the multisystemic therapy program. these plans will be effective in insuring that these children continue to learn alongside their peers in regular classroom settings, as much as possible, while still getting the accommodation needed to be successful in the curriculum. however, the implementation of ieps should not be seen as a permanent solution for children with behavioral health issues, like oppositional defiant disorder. while ieps typically contain several educational objectives that make it easier for a child to understand the curriculum, 136 they do not target solutions to the cognitive, behavioral, and social struggles children with disruptive behavioral issues face. these children with behavioral health disorders need programs like multisystemic therapy to address these cognitive, behavioral, and social issues so that youths are better prepared to function within and to keep up with the pace of the general classroom setting as well as the curriculum they are expected to follow. ieps will not follow children into post-secondary education or the workforce, but the behavioral coping skills they develop within the multisystemic therapy will follow them beyond the classroom. ————————————————————————————— 129. id. 130. id. 131. id. 132. id. 133. id. 134. county health rankings, supra note 114. 135. gail belsky, what is an iep?, understood, https://www.understood.org/en/ articles/what-is-an-iep [https://perma.cc/64er-389l] (last visited mar. 23, 2023). 136. id. https://perma.cc/64er-389l https://www.understood.org/en 2024] defying the odds 403 supervisors over the program should be required to be, at minimum, master’s-prepared clinicians with training in behavioral and cognitive behavioral therapies and pragmatic family therapies. 137 at least 66% of therapists must have a master’s degree in counseling or social work. 138 to meet the demands of the program, it is important to utilize indiana code section 2020-18.5-1, which created a grant provides funding for training for school counselors in kindergarten to grade twelve schools to obtain a mental health counselor license under indiana code section 25-23.6-8.5. 139 this grant would fund a school counselor to receive the master’s degree needed to supervise the program. further, it would be beneficial if the supervisor understood juvenile justice and child welfare systems. 140 they must have some experience in managing severe family crises that involve safety risks to the family. 141 clinical teams for the mst program would include a staff of two to four therapists and a supervisor.142 all staff within the program would complete a standard five-day orientation. after which the team would participate in weekly consultation with an expert on the program, quarterly booster training, ongoing organizational assistance, and quality assurance support through the monitoring of treatment adherence. 143 the targeted population for mst is delinquent or antisocial youth between the ages of twelve-to-seventeen-years-old who are at imminent risk of out-ofhome placement due to criminal offenses; those who experience physical aggression at home, at school, or in the community; and those who express verbal aggression, or verbal threats of harm to others. 144 the indiana code defines a delinquent child who needs care, treatment, or rehabilitation as a child who, before becoming eighteen years of age, . . . commits a delinquent act; and needs care, treatment, or rehabilitation that (a) the child is not receiving; (b) the child is unlikely to accept voluntarily; and (c) is unlikely to be provided or accepted without the coercive intervention of the court. 145 a child could be considered delinquent and in need of care for a number of reasons including, but not limited to, violations of compulsory school ————————————————————————————— 137. california evidence based clearinghouse for child welfare, supra note 118. 138. id. 139. ind. code § 20-20-18.5-1 (2015). 140. california evidence based clearinghouse for child welfare, supra note 118. 141. id. 142. id. 143. id. 144. multisystemic therapy, the family partnership, https://www.thefamilypartnership. org/services/mental-health-therapies/multisystemic-therapy/ [https://perma.cc/ug22-bups] (last visited mar. 24, 2023). 145. ind. code § 31-37-2-1 (2022). https://perma.cc/ug22-bups https://www.thefamilypartnership indiana health law review [vol. 21:387 404 attendance,146 leaving home, or a designated location without reasonable cause or parental approval, 147 being out past curfew, 148 or disobeying a parent, guardian, or custodian (such as a teacher or school administrator). 149 these “delinquent acts” can be minor and are often over policed, leading to out-ofhome and out-of-school placements to punish the child for committing these acts. multisystemic therapy can be used to target a broad range of behavioral health issues, many of which are diagnosed comorbidly with oppositional defiant disorder. 150 these disruptive, impulse-control, and conduct disorders work well in a multisystemic therapy setting because the treatment works to address the distress in the individual and others within his or her immediate social context (i.e. family, peer group, school administration). 151 these disorders tend to be more common in males than in females, although the degree of predominance between genders may vary across disorders and within a disorder at different ages. 152 children with oppositional defiant disorder are at risk for eventually developing other disorders, including anxiety and depressive disorders which can further lead to increased risks of developing substance-use disorder. 153 this raises their risk of being incarcerated for crimes associated with substance use and possession of illegal substances (e.g., driving under the influence, or charges of possession). addressing this disorder as soon as possible reduces the risk of other disorders developing and further reduces the risk of incarceration. one roadblock of the mst program is that it excludes youth living independently or without a primary caregiver; those who are actively suicidal, homicidal, or suffering from psychosis; and those who have severe difficulties with social communication and interaction, such as those with autism. 154 this is mainly because the program’s focus is to improve behavioral responses to a child’s environment. this program focuses on the child’s environment in school, home, and community. it is crucial that they can communicate effectively with a caregiver who can provide them with adequate support during this therapy. while other programs may be available to those who do not qualify as participants in the multisystemic therapy program, this issue is beyond the scope of this note. ————————————————————————————— 146. ind. code § 31-37-2-3 (2022). 147. ind. code § 31-37-2-2 (2022). 148. ind. code § 31-37-2-5 (2022). 149. ind. code § 31-37-2-4 (2022). 150. dsm-v, supra note 9 at 465. 151. california evidence based clearinghouse for child welfare, supra note 118. 152. dsm-v, supra note 9 at 461. 153. id. 154. california evidence based clearinghouse for child welfare, supra note 118. 2024] defying the odds 405 b. legislative changes to support therapy implementation under the federal patient protection and affordable care act, group and individual health insurance providers must provide essential health benefits in accordance with federal and state laws. “essential health benefits” must include: “ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.”155 thirty-four states have licensed multisystemic therapy providers, and some states, including indiana, fund these programs through medicaid state plans. 156 in indiana, outpatient coverage for mental health treatment is available to the following provider types, who are enrolled within the managed care entities (mce) network: outpatient mental health treatments, community mental health centers (cmhcs), psychologist, psychiatrist, health service providers in psychology, certified social workers, certified clinical social workers, psychiatric nurse, independent practice school psychologists, advanced practice nurses (credentialed in psychiatric or mental health nursing by the american nurses credentialing center), and persons holding a master’s degree in social work, marital and family therapy, or mental health counseling, under 405 iac section 5-20-8.157 currently, the indiana department of insurance may review insurance plans for parity compliance only to the extent that an insurance plan chooses to include any coverage of behavioral health care. 158 however, it lacks any enforcement ability to investigate violations that may occur in practice. 159 by implementing legislation like timothy’s law, the indiana department of insurance would be given the authority to investigate parity violations. 160 1. timothy’s law on december 22, 2006, new york state enact “timothy’s law” which expanded coverage requirements to include comparable coverage for adults and children with “biologically based mental illness or serious emotional disturbance disorders” as provided for treatment for physical illness. 161 biologically based mental illness is defined by the law as “a mental, nervous, or ————————————————————————————— 155. patient protection and affordable care act of 2010, 42 u.s.c. § 18022(b)(1)(a)-(j). (emphasis added) 156. county health rankings, supra note 114. 157. outpatient mental health services, 405 ind. admin. code 5-20-8 (2016). 158. indiana behavioral health commission, supra note 115. 159. id. 160. id. 161. timothy’s law, 2006 n.y. als 748, 2005 n.y. s.n. 8482 (2006). indiana health law review [vol. 21:387 406 emotional condition that is caused by a biological disorder of the brain and results in a clinically significant, psychological syndrome that substantially limits the functioning of the person with the illness.”162 the law further defines a person with emotional disturbance disorders as someone with a diagnosed disorders such as attention deficit disorder, disruptive behavioral disorders, or pervasive development disorders, who have had suicidal or self-destructive behaviors, significant psychotic symptoms, or behavior that places the patient at substantial risk of removal from the household. 163 the intent of timothy’s law was to strengthen and enhance the protections established by federal law, as well as to ensure that mental health coverage is provided by insurance companies and health maintenance organizations in comparable terms to other healthcare services. 164 oppositional defiant disorder would fall under coverage of this law because it is an emotional disturbance disorder and is a biologically based mental illness that substantially limits the functioning of the person with the illness as improper treatment of the disorder can lead to impairments in the child’s present and future emotional, social, academic and occupational development. under the law, the superintendent of insurance will monitor the implementation of the coverage required under the law and take any action as necessary to ensure that insurers’ contracts or policies do not contain unreasonable definitions of mental or emotional disorders or ailments in their policies. 165 the superintendent will also work with the office of mental health and perform a study on the effectiveness of the mental health parity which would include a comprehensive analysis of the costs associated with coverage pursuant to the act, a record of the number of policy holders which have elected to purchase other mental health coverage, and a comparison of the type and number of illnesses for which coverage has been provided during the study period, which would occur over a two-year-span.166 indiana currently allows mst services to be funded through medicaid reimbursement by using therapy cpt codes, and, in eligible cases, indiana department of child services funding can be used to cover the cost of treatment.167 by implementing legislation similar to timothy’s law, parity treatment of oppositional defiant disorder and other behavioral health disorders through programs like multisystemic therapy would also be covered under an individual’s private insurance plan. this means that multisystemic therapist working within the school could bill the individual student’s insurance company to cover the cost of the therapy versus the funding coming from an education fund, or through increased taxpayer dollars. ————————————————————————————— 162. id. 163. id. 164. id. 165. id. 166. id. at § 7 (a-b). 167. faq: indiana statewide implementation of mst, in.gov, https://www.in.gov/ children/files/indiana-mst-faq.pdf [https://perma.cc/zx3f-bgex] (last visited feb. 7, 2024). https://perma.cc/zx3f-bgex https://www.in.gov 2024] defying the odds 407 c. considerations the average cost for multisystemic therapy is $6,000 per juvenile participant, which is substantially less than the cost of incarceration, group home placement, or residential treatment.”168 having the cost of the program covered under insurance would further reduce the burden on individuals and taxpayers. the cost to imprison a child in the state of indiana can reach to over $96,000 per year in taxpayer dollars, as opposed to the less than $10,000 average cost to educate the child in public school. 169 for children who become recidivist after their time in juvenile detention, the cost of detention for adults in the state averages over $19,000 per year. 170 making the investment, even into costly programs such as multisystemic therapy, to properly address disruptive behavior disorders, like oppositional defiance disorder, prior to the initial out of home placement, will reduce the rate of incarceration, and thus greatly reduce the cost of housing detained individuals throughout the state. another roadblock of the program is the apprehension towards programs that may promote “social-emotional learning.” social-emotional learning was previously seen as a crucial program in schools, and many districts were developing practices to support social and emotional development throughout various parts of the school day. 171 implementing these practices reportedly made improvements in student behavior and outcomes. 172 however, because of the debate over critical race theory in schools, social-emotional learning has also fallen under attack by critics. 173 social-emotional learning is a process in which children develop life skills, such as communication, problem solving, and managing stress to help them be successful learners and communicators inside and outside of the classroom. 174 multisystemic therapy may fall under the category of social-emotional learning because it targets behavioral and emotional responses to a child’s environment, much like social-emotional learning. despite critical debate over the use of social-emotional learning, programs ————————————————————————————— 168. jessica ann garascia, note, the price we are willing to pay for punitive justice in the juvenile detention system: mentally ill delinquents and their disproportionate share of the burden, 80 ind. l.j. 489, 509–10 (2005). 169. youth incarceration in indiana, no kids in prison campaign, https://www. nokidsinprison.org/explore/indiana/?section=race-interactive [https://perma.cc/qhy9-gz26] (last visited oct. 10, 2022). 170. how much does it cost to keep an offender in prison?, in.gov, https://faqs. in.gov/hc/en-us/articles/115005238288-how-much-does-it-cost-to-keep-an-offender-in-prison[https://perma.cc/yms2-c374] (last visited, oct. 16, 2022). 171. emily tate sullivan, demystifying social-emotional learning, and the controversy surrounding it, edsurge (sept. 30, 2022), https://www.edsurge.com/news/2022-09-30demystifying-social-emotional-learning-and-the-controversy-surrounding-it [https://perma.cc/24qg-42aq]. 172. id. 173. id. 174. id. https://perma.cc/24qg-42aq https://www.edsurge.com/news/2022-09-30 https://perma.cc/yms2-c374 https://in.gov/hc/en-us/articles/115005238288-how-much-does-it-cost-to-keep-an-offender-in-prison https://faqs https://perma.cc/qhy9-gz26 https://www indiana health law review [vol. 21:387 408 like multisystemic therapy are beneficial in developing essential life skills to be productive members of society. research shows that having strong socialemotional competency will lead to both short-term and long-term successes. 175 students who undergo social-emotional learning are more likely to graduate from high school or college, be more career ready, and develop healthier and more positive relationships.176 v. recommendations and conclusion schools can be an ideal outlet for students needing mental health support as they spend more time interacting at school than at home. at school, children can receive support from teachers, counselors, coaches, and other staff. 177 however, school staff are stretched thin, and many families are unable to cover the cost of treatment on their own. in the indiana behavioral health commission’s september 2022 report, access to behavioral healthcare has been identified as a key challenge across the state. 178 this challenge is typically driven by affordability and insurance coverage. supplemental programs are crucial in making sure that children needing this support receive it. 179 multisystemic therapy can be the model supplemental program as mst therapists work within the school and community to help youth struggling with mental health and behavioral issues. 180 these therapists also provide school faculty and staff with tools to address troubling situations with students who have disruptive behavior disorders. 181 when schools are able to develop mental health support, the entire community benefits. children who have the resources to address mental and behavioral challenges early are more likely to gain skills to be successful in school and life. through this, the threat of later harm or crime is significantly reduced. 182 a twenty-one year follow up evaluation of mst showed a reduced rate of recidivism and less frequent offenses among its patients as compared to individual therapy participants, in programs like cognitive behavioral therapy. 183 it is recommended that indiana pass legislation like new york’s timothy’s law to create parity expansion through insurances, which will allow for coverage of multisystemic therapy to be used as an alternative to disciplinary measures for children with oppositional defiant disorder. ————————————————————————————— 175. id. 176. id. 177. khan, supra note 56. 178. indiana behavioral health commission, supra note 115, at 39. 179. khan, supra note 56. 180. school safety: addressing school shootings, student mental health, and other related factors, mst services, https://www.mstservices.com/school-safety-resources [https://perma.cc/ pd67-rrqj] (last visited oct. 16, 2022). 181. id. 182. id. 183. indiana behavioral health commission, supra note 115. https://perma.cc https://www.mstservices.com/school-safety-resources structure bookmarks indiana health law review indiana health law review volume xv 2018 number 2 articles deploying prescription drug monitoring to address the overdose crisis: ideology meets reality leo beletsky* “the greatest dangers to liberty lurk in insidious encroachment by men of zeal, well-meaning but without understanding.” olmstead v. united states, 277 u.s. 438, 479 (1928) (brandeis, j., dissenting). i. introduction the united states is in the midst of a historic drug overdose crisis. each day, well over 100 americans die of drug overdose, driven increasingly by street opioids.1 largely as a result of these deaths, overall life expectancy is steadily declining, and especially among certain groups of the american public—a trend seldom observed outside of conflict settings.2 as deaths involving prescription painkillers have leveled off, the latest data on heroin and illicitly-manufactured * associate professor at the school of law & bouvé college of health sciences, northeastern university and adjunct professor at the university of california in san diego school of medicine. j.d., temple university beasley school of law, 2008; m.p.h., brown university, 2004; a.b., vassar college, 2000. financial assistance was provided by the northeastern school of law research stipend program. a preliminary version of this article was presented at the indiana health law review’s symposium ideology meets reality, as well as faculty colloquia at northeastern university school of law, suffolk university school of law, the data privacy in the digital age symposium at the us department of health and human services, and oxford university faculty of law’s center for socio-legal studies. johnathon card, amanda dolan, daniel espinoza, mark martinez, sarah scotland, sarah seymour and zachary siegel provided valuable research assistance. 1. holly hedegaard et al., nchs data brief no. 294: drug overdose deaths in the united states, 1999–2016, u.s. dep’t of health & human servs., ctrs. for disease control & prevention & nat’l ctr. for health stats. (dec. 2017), https://www.cdc.gov/nchs/data/ databriefs/db294.pdf [https://perma.cc/9qrm-z3k3] (last accessed on december 22, 2017). 2. kenneth d. kochanek et al., nchs data brief no. 293, mortality in the united states, 2016, u.s. dep’t of health & human servs., ctrs. for disease control & prevention & nat’l ctr. for health stats (dec. 2017), https://www.cdc.gov/nchs/data/databriefs/db293.pdf [https://perma.cc/sc5w-q46y] (last accessed on december 22, 2017). http://doi.org/10.18060/3911.0046 140 indiana health law review [vol. 15:139 fentanyl fatalities could not be more dire.3 these deaths have more than quintupled between 2010 and 2016,4 with the rate of fentanyl-attributable fatalities doubling in a single twelve-month period.5 as with past crises, what has been dubbed an “opioid epidemic”6 has invoked an expansion in the number and scope of public health surveillance efforts. since the dominant narrative pins the root cause of this crisis on over-prescription and diversion of prescription drugs, the response has focused on tracking and suppression of medication prescription and dispensation.7 by collecting information on who is prescribing, dispensing, and receiving scheduled drugs, prescription drug monitoring systems (pdmps) are intended to help identify problem patients, rogue prescribers, and pharmacists who may be diverting potentially addictive and otherwise risky drugs.8 by imposing this surveillance framework, programs are also thought to deter “aberrant” practices.9 the concept behind these systems is far from new,10 but the current crisis has spawned unprecedented extension in their number, scope, funding, and legal mandates. every state and the district of columbia has authorized a pdmp.11 much has 3. hedegaard et al., supra note 1, at 4. 4. josh katz, the first count of fentanyl deaths in 2016: up 540% in three years, n.y. times (sept. 2, 2017), https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drugoverdose-deaths.html [http://perma.cc/b8bf-vhu3]; ctrs. for disease control & prevention & u.s. dep’t of health & human servs., drug overdose deaths in the united states, 1999–2015, nat’l ctr. health stats. (feb. 2017), https://www.cdc.gov/nchs/data/ databriefs/db273_table.pdf#5 [http://perma.cc/rt2q-4nxx]. 5. hedegaard et al., supra note 1, at 4. 6. nabarun dasgupta, leo beletsky & dan ciccarone, opioid crisis: no easy fix to its social and economic determinants, 108 am. j. pub. health 182 (2018) (arguing that the current framing of, and response to the crisis fails to address its social and economic drivers). 7. the regulatory framework for the collection of patient data on the prescription and dispensing of controlled substances is not new to the u.s., but the recent efforts mark a sharp scaleup in the scope and utilization of these mechanisms. 8. see e.g. prescription drug monitoring programs: a guide for healthcare providers, 10 samhsa in brief 4 (2017), https://store.samhsa.gov/shin/content/sma16-4997/sma16-4997.pdf [https://perma.cc/588s-veps] (describing the concept of aberrant” prescriber and patient behavior, and noting the difficulty in its previse definition) 9. id. see also michel foucault, discipline and punish: the birth of the prison 195201 (ny: vintage books 1995) (noting the introduction of “panopticon” surveillance is to “induce ... a state of conscious and permanent visibility that assures the automatic functioning of power. so to arrange things that the surveillance is permanent in its effects, even if it is discontinuous in its action; that the perfection of power should tend to render its actual exercise unnecessary.”) 10. see infra notes 78-80, 87 and accompanying text. 11. what states need to know about pdmps, ctrs. for disease control & prevention (oct. 3, 2017), http://www.cdc.gov/drugoverdose/pdmp/index.html [https://perma.cc/w2bj-s6un] (last visited dec. 5, 2017); see also prescription drug monitoring programs, nat’l all. for model state drug laws, http://www.namsdl.org/prescription-monitoring-programs.cfm [https://perma.cc/4h84-n7f9] (last visited dec. 5, 2017). 2018] deploying prescription drug monitoring 141 been written to extol the potential of these programs—and their enabling legal instruments—to curb drug misuse and diversion.12 but the discourse on pdmps and their role in addressing the drug-related harms has been situated primarily in the province of criminal justice and criminal law,13 allowing these interventions to proliferate without sufficient scrutiny from ethical, sociolegal, and empirical public health perspectives. in parallel with the rhetorical shift towards a “public health response” to the overdose crisis, the lens of health law and public health law research has begun to be trained on pdmps.14 in addition, privacy concerns about pdmps have spawned a number of important cases, including recent appellate decisions with wide-ranging implications.15 this article adds to this nascent discourse. i argue that the zeal with which we have traditionally pursued supply reduction measures to address drug-related harms16 reflects the legal and system design of pdmps, as well as the implementation of these programs. in view of their law enforcement roots, pdmps evolved primarily to track and restrict the supply of potentially addictive substances—the animating mission of u.s. drug policy.17 this is why the success of pdmps has for too long been measured primarily by 12. andrew kolodny & thomas frieden, ten steps the federal government should take now to reverse the opioid addiction epidemic, 318 jama 1537 (2017) (making the case for pdmps, and other supply reduction strategies as an effective tool to reduce overdose deaths and prevent future cases of addiction); nathan trexler, developments in delaware health law: addressing prescription drug abuse, 14 del. l. rev. 29 (2013) (reviewing delaware’s new prescription drug monitoring program, calling the new laws “safeguards in safely prescribing to a sensitive patient population); amy l. cadwell, in the war on prescription drug abuse epharmacies are making doctor shopping irrelevant, 7 hous. j. health l. & pol’y 85 (2006) (arguing pdmps reduce doctor shopping and diversion to illegal market). 13. miles d. schreiner, a deadly combination: the legal response to america's prescription drug epidemic, 33 j. legal med. 529 (2012) (arguing that doctors should be legally responsible for using pdmps); neha casturi, a modern day apocalypse: the pill mill epidemic, how it took texas by storm, and how texas is fighting back, 14 tex. tech. admin. l. j. 445 (2012) (contending that the texas pdmp law wiped out pill mills and doctor shopping in the state); joanna shepherd, combating the prescription painkiller epidemic: a national prescription drug reporting program, 40 am. j. l. & med 85 (2014) (arguing against state pdmps in favor of a national system); ashley dutko, florida’s fight against prescription drug abuse: prescription drug monitoring program, 34 nova l. rev. 739 (2010) (heralding the effectiveness of florida’s pdmp as a response to doctor shopping and drug diversion). 14. see, e.g., d. b. brushwood, maximizing the value of electronic prescription monitoring programs, 31 j. l., med. & ethics 41 (2003); see also rebecca haffajee, preventing opioid misuse with prescription drug monitoring programs: a framework for evaluating the success of state public health laws, 67 hastings l. j. 1621 (2016); devon t. unger, minding your meds: balancing the needs for patient privacy and law enforcement in prescription drug monitoring programs, 117 w. va. l. rev. 345 (2014). 15. see infra notes 264-67 and accompanying text. 16. see infra notes 73-75 and accompanying text. 17. see infra notes 178, 182-83 and accompanying text. 142 indiana health law review [vol. 15:139 their impact on suppressing medication supply, with too little regard for the more meaningful metrics anchored to reducing risky drug use and overdose.18 government surveillance systems, including various electronic databases like pdmps, are well-understood to have a sinister side.19 monitoring mechanisms and the predictive technologies they deploy may perpetuate biases and disproportionate impact on underprivileged citizens, given their common roots with other kinds of surveillance of poor, immigrant, and stigmatized communities.20 as an exercise of state “police power,” public health is never immune from operationalizing social control21 that responds to political and normative pressures.22 this implies the imperative to treat systems like pdmps with caution and deliberate about their proper calibration that guards against unintended consequences. such discourse is especially important at a time when the nation’s overdose crisis has spurred a rapid expansion in the number, scope, and legal authority of pdmps.23 ultimately, pdmps are here to stay. but deriving full value from effective public health surveillance without triggering unintended adverse consequences demands careful calibration. how do we decide what information must be collected? who is able to access surveillance data? how are these data to be used? how must they be protected from undesired public and other disclosure? to answer these questions, the legal and bioethical canon is supposed to draw on a familiar balancing test: to weigh the state imperative to protect the public’s health against the patients’ individual privacy and confidentiality interests.24 supported by published and original empirical data, this article argues that surveillance efforts that fail to adequately safeguard patient data do much more than harm individual rights; by undermining patient trust and creating a system of perverse incentives, they can push patients away from seeking appropriate, timely help. at the population level, this hampers disease monitoring and control efforts, aggravating the very problems these policies and programs were intended to ameliorate. in other words, this policy heuristic fails to account for behavioral theory, sociolegal critique, and empirical evidence on the impact of public health 18. see infra notes 211-21 and accompanying text; see also table 1 infra. 19. see infra notes 62-64 and accompanying text. algorythms 20. see infra notes 206-08 and accompanying text. see also john gilliom, overseers of the poor (u. chicago press 2001). 21. wendy e. parmet, populations, public health, and the law 13, 117-19 (geo. u. press 2009). 22. id. see also foucault, supra note 9, at 195-99 (introducing the concept of panopticon in the context of disease surveillance and quarantine). 23. the number of states with pdmps grew rapidly from thirteen in 1999 to fifty states and washington, d.c., in 2016. pdmp access and registration, the policy surveillance program: a law atlas project (2016) http://www.lawatlas.org/query?dataset=prescriptionmonitoring-program-laws-1408223332 [http://perma.cc/qy9d-274f]; see infra notes 177-80 and accompanying text. 24. wendy k. mariner, mission creep: public health surveillance and medical privacy, 87 bos. u. l. rev. 347 (2007). 2018] deploying prescription drug monitoring 143 surveillance programs. the article unfolds as follows: part ii provides an overview of public health surveillance systems, the positioning of patient confidentiality as a countervailing consideration to balance individual rights with community interests, and the role of ideology in shaping the design, legal posture, and implementation of such systems. it then situates pdmps and their early evolution within this larger public health surveillance story. part iii brings this historical discussion to the present day by focusing specifically on the role of pdmps within the overdose crisis. it then reviews current programmatic and legal posture of pdmps, with focus on law enforcement access, criminal justice data integration, and the continued struggle to harmonize the law enforcement-driven design of prescription drug monitoring with its supposed public health mandate. part iv reviews the available empirical evidence on pdmp impact and adds original qualitative empirical data, supported by emerging jurisprudence elevating privacy concerns about these systems. finally, in part v, i synthesize the preceding analysis by proposing changes to pdmp policies and programs that are informed by evidence rather than ideology and are designed to maximize the utility of these programs while minimizing their risk of considerable unintended consequences. ii. public health surveillance and the health care encounter a. patient privacy and public health surveillance we trust the information we share with our health care providers to be received in confidence and without judgment.25 this is why the patient’s right to confidentiality is fundamental to the provision of medical care. at its core, this right protects the deeply private information gathered in the course of medical encounters from disclosure to third parties without the patient’s express consent;26 the very fact that a patient has sought medical assistance typically comes under the scope of restricted information.27 from the normative perspective, such protections derive their justification in patients’ expectation of privacy, agency, and control over information (including 25. though the “do no harm” mantra is the most well-known element of the hippocratic oath, a less universally-known element of the declaration holds “sacred” any information learned in the course of medical practice. oxford treasury of sayings & quotations 407 (susan ratcliffe ed., 4th ed. 2011) (“and whatsoever i shall see or hear in the course of my profession, as well as outside my profession . . . if it be what should not be published abroad. i will never divulge, holding such things to be holy secret.”). across the world, this normative and instrumental significance has overtime become codified by constitutional, statutory, and administrative protections, professional ethics rules, institutional policies, and an extensive canon from both domestic and international tribunals. for this international perspective, see generally, declaration of geneva, world med. assoc. (1948). 26. see generally h. tristram engelhardt, jr., the foundations of bioethics 337 (2nd ed. 1996). 27. id. see 45 c.f.r. § 160.103 (2017). 144 indiana health law review [vol. 15:139 possibly embarrassing, incriminating, or otherwise damaging facts) revealed during the health care encounter.28 this right is central to a bioethical and medical providers’ professional responsibility framework designed to recalibrate the balance of power within the inherently unequal provider-patient relationship.29 as it has been enshrined in bioethical canon,30 the rights-based framing of confidentiality empowers patients to avail themselves of the unique trust understood to be at the core of the provider-patient relationship since ancient times.31 conversely, the absence of this trust—and the attendant sense of fear and pessimism32—further exacerbates the fundamental vulnerability of patients at the hands of medical providers. the right to privacy and confidentiality also has vital instrumental value. perceived or real confidentiality breaches erode the trust necessary for the provision of effective medical care. first, without confidence that their physical and mental health concerns and conditions will be held in secret, patients may delay or forgo essential services, with detriment to their health.33 second, the lack 28. one example is in help-seeking during overdose events. laws in most (32, 64%) states now provide good samaritan protections for victims and witnesses of such events in order to dispel fears of legal consequences from calling emergency medical assistance. state legislation: overdose prevention, drug policy all. (jan. 2016), http://www.drugpolicy.org/sites/default/files/ fact%20sheet_state%20based%20overdose%20prevention%20legislation%20%28january%2 02016%29.pdf [http://perma.cc/7ng3-eb92]. 29. see i. kleinman et al., bioethics for clinicians: 8. confidentiality, 156 canadian med. ass’n j. 521 (feb. 15, 1997). 30. bioethical pillars of beneficence, autonomy, and justice seek to address many of the types of patient abuses and human rights violations that may occur in healthcare settings. see generally engelhardt, jr., supra note 26. some commentators consider non-malfeasance and human dignity as central facets of bioethics. see generally international dual loyalty working group & physicians for human rights, dual loyalty and human rights in health professional practice: proposed guidelines & institutional mechanisms (2002), http://physiciansforhumanrights.org/library/reports/dual-loyalty-and-human-rights-2003.html [https://perma.cc/6dtu-qfbr] [hereinafter international dual loyalty working group]. 31. there is some debate as to whether the concepts of trust and a “rights-based” framework are in opposition to one another, but i agree with mark hall’s conceptualization of these frameworks as completely compatible. see generally mark a. hall, law, medicine, and trust, 55 stan. l. rev. 463 (2002) (opposing the view of provider-patient trust as an inherently and unacceptably paternalistic concept, as framed by some scholars); see, e.g., sheldon f. kurtz, the law of informed consent: from “doctor is right” to “patient has rights”, 50 syracuse l. rev. 1243 (2000). 32. hall, supra note 31, at 474 (“trust consists of an optimistic attitude towards one’s vulnerability, whereas distrust connotes an attitude of wariness or pessimism.”). 33. for example, since medical and law enforcement emergency response is linked, many drug users and others who witness drug overdoses delay or forgo calling for professional help out of fear of adverse legal consequences. see, e.g., leo beletsky et al., prevention of fatal opioid overdose, 308 jama 1863, 1863-64 (2012) (providing a general discussion of this paradigm and the role of 9-1-1 good samaritan laws); see also caleb banta-green et al., police officers’ and 2018] deploying prescription drug monitoring 145 of trust can produce dangerous gaps in patient-provider communication, whereby patients may misstate or omit important information. such gaps can hamper appropriate diagnosis, treatment, and follow-up.34 third, the very presence or absence of trust in the patient-provider relationship has measurable therapeutic effects.35 likely related to the dynamics of the self-healing “placebo effect,” the extent to which a patient perceives her provider as trustworthy and dependable can enhance the health benefit of the patient’s treatment.36 conversely, unauthorized disclosure of sensitive patient information and associated stigmatization can cause a cascade of harm in physical and mental health, economic, family, social, and other dimensions.37 confidential medical care is not equally distributed. there is a growing, global body of empirical data documenting the disparities in systemic violations to confidentiality and other rights of patients belonging to marginalized groups. this includes ethnic minorities;38 people living with hiv/aids;39 people who use drugs;40 and the poor.41 reflecting the power imbalance that affects these groups in other domains, confidentiality violations disproportionately impact these patients because they are subject to increased state control, surveillance, and paramedics’ experiences with overdose and their knowledge and opinions of washington state’s drug overdose-naloxone-good samaritan law, 90 j. urb. health 1102, 1102-03 (2013). 34. thomas a. laveist et al., mistrust of health care organizations is associated with underutilization of health services, 44 health servs. res. 2093, 2093-3015 (2008) (finding that patient mistrust leads to underutilization of health care); katrina armstrong et al., distrust of the health care system and self-reported health in the united states, 21 j. gen. intern. med. 292, 292-97 (2006) (finding that patient distrust is associated with worse self-reported health). 35. see hall, supra note 31, at 470 (“trust is shown to be essential and unavoidable in medical relationships because patients need and want to trust, and without trust medical relationships never form or are entirely dysfunctional.”). 36. id. at 479-80. 37. id. at 473-88. 38. alphia abdikeeva, roma health rights in macedonia, romania, and serbia: a baseline for legal advocacy, open society founds. (june 2013), https://www.opensocietyfoundations.org/ sites/defau lt / files/roma-health -righ ts-macedonia-rom an ia-serb ia-2 0 130628 .pdf [https://perma.cc/v46d-awbv] (noting violations to right to privacy and confidentiality of roma individuals). 39. judith a. schwartzbaum et al., physician breach of patient confidentiality among individuals with human immunodeficiency virus (hiv) infection: patterns of decision, 80 am. j. pub. health 829 (1990) (outlining confidentiality breach in healthcare sector toward people living with hiv/aids). 40. lianne l. hu et al., privacy protection for patients with substance use problems, 2 substance abuse & rehab. 227 (2011) (discussing privacy vulnerabilities in the substance use disorder field). 41. amanda dennis et al., a qualitative exploration of low-income women's experiences accessing abortion in massachusetts, 25 women’s health issues 463 (2015) (finding that lowincome women reported fears of confidentiality violations while accessing abortion services). 146 indiana health law review [vol. 15:139 stigmatization;42 they also often lack access to both formal and informal mechanisms to vindicate their individual rights and to address privacy violations.43 effective flows of accurate information play a vital role in informing decisions on both the individual and community health. given accurate information about the patient’s symptoms, risk factors, and medical history, providers can combine their clinical judgment with the latest available research to make diagnostic and treatment decisions. despite its critical importance and deep philosophical roots, the right to patient privacy and confidentiality is nowhere absolute, as it must be balanced with community interests.44 common law and statutory limitations of this right are acknowledged, for example to control emerging diseases and other public health and disease surveillance activities,45 and to prevent clear and present danger to the patient or to third parties.46 international, national and local laws around the world reflect the imperative to balance community interests in health and safety with the individual patient’s right to privacy.47 many jurisdictions mandate provider disclosure of confidential patient information in certain cases, including virulent infections, child abuse, and domestic violence.48 but normative and legal protections generally require such disclosure to be narrowly tailored and delineated by safeguards, for example in ways that facilitate testing and treatment.49 data gleaned in the course of health care encounters also holds enormous 42. see, e.g., mariner, supra note 24, at 349 (noting the history of public health surveillance efforts in the u.s. as affecting economically marginalized communities and ethnic minorities). 43. deborah l. rhode, access to justice (oxford u. press 2004) (outlining disparate access to justice system along social class lines); michele estrin gilman, the class differential in privacy law, 77 brook. l. rev. 1389 (2012) (reviewing the methods of surveillance and privacy violations unique to lower class communities). 44. see engelhardt, jr., supra note 26, at 337 (discussing the parallels between the exemptions in provider-patient privilege and that governing members of the clergy and attorneys), and at 338-39 (discussing the balancing of interests in allowing such exceptions to the confidentiality rule). 45. chris verity & angus nicoll, consent, confidentiality, and the threat to public health surveillance, 324 brit. med. j. 1210 (2002). 46. see, e.g., tarasoff v. regents of univ. of cal., 17 cal. 3d 425, 435-36 (cal. 1976). this rule has been adopted widely by the courts throughout the united states. many jurisdictions around the world follow similar principles. 47. see, e.g., nino kiknadze & leo beletsky, overview of the gaps in the health care legislation in georgia: short-, medium-, and long-term priorities, 15 health & human rights j. 32, 32-40 (2013); gabriela alcheva, filip gerovsky & leo beletsky, implementation of patients’ rights legislation in the republic of macedonia: gaps and disparities, 15 health & human rights j. 20, 20-31 (2013). 48. see engelhardt, jr., supra note 26, at 338-39. 49. see amy l. fairchild et al., searching eyes: privacy, the state, and disease surveillance in america (u. california press 2007). 2018] deploying prescription drug monitoring 147 value to the public. by tracking cases of emerging contagions, genetic problems among newborns,50 clusters of poisonings, injuries, or cancer diagnoses, as well as antisocial behaviors like child abuse, surveillance data are essential to fully understanding community hazards.51 the aggregate sum of medical encounters forms a critical component of a society’s public health defense—health care settings create a “sentinel surveillance” network to discern the prevalence of certain conditions and risk behaviors, track emerging health threats and offer a platform for prevention and intervention efforts. only when armed with such information can governments mount timely and proportional responses to public health threats.52 thus, up-to-date data on where and how diseases spread and how best to control them are critical to drive state efforts to protect the public. generating the best available evidence for individuals and populations requires a number of elements, with patient confidentiality being one of the most fundamental. yet, as with other forms of government surveillance,53 these systems are prone to abuse. in the face of emerging public health threats (be they real or perceived), policymakers often respond by mounting expansive, intrusive monitoring. these invasive initiatives certainly affect individuals; the failure of policymakers to adequately protect patients’ rights and confidentiality can generate adverse impacts on a population level. with concrete and consistent safeguards, individuals are typically willing to cede some measure of confidentiality for the benefit of the community. conversely, lack of trust in health providers and concern about legal, social, and other consequences of unauthorized disclosure push risky practices and stigmatized diseases underground. fear of disclosure of confidential health information to employers, family members, mass media, and law enforcement can create dangerous barriers to preventative care, emergency services, and other domains of health care. a real or perceived risk that confidential medical information may be used to inflict psychological, social, economic, or other harm acts as a direct disincentive to patients seeking professional help or being completely forthright during their 50. newborn screening reports and publications, nat’l newborn screening & genetics res. ctr., http://genes-r-us.uthscsa.edu/newborn_reports [https://perma.cc/beg3-3hn5] (last updated nov. 3, 2014). 51. over time, patient records can also help researchers glean lifesaving insights about factors shaping health and disease. 52. flint represents a failure of such a system, as it took over a year to identify the lead poisoning trend. much of the preliminary data that sounded the alarms was collected and identified within a patient care setting, highlighting the value of sentinel surveillance. see events that led to flint’s water crisis, n.y. times (jan. 21, 2016), https://www.nytimes.com/interactive/2016/ 01/21/us/flint-lead-water-timeline.html [https://perma.cc/a3en-tmk7]. 53. see barton gellman, nsa broke privacy rules thousands of times per year, audit finds, wash. post (aug. 25, 2013), https://www.washingtonpost.com/world/national-security/nsa-brokeprivacy-rules-thousands-of-times-per-year-audit-finds/2013/08/15/3310e554-05ca-11e3-a07f49ddc7417125_story.html?utm_term=.633543b25f3c [https://perma.cc/9nwu-vsyv]; see generally fairchild et al., supra note 49. 148 indiana health law review [vol. 15:139 interactions with healthcare providers. such risk may push patients to seek treatment outside of formal channels. this opens patients up to increased exposure to poor quality care and can potentially nudge them away from protective and towards risky health behaviors. when patients delay treatment, misrepresent their symptoms, and withhold information, public health authorities also lose their ability to contain and prevent emerging threats.54 on the population level, these abuses can wreak havoc.55 in special settings, such as schools, armed forces, or employer-sponsored health clinics, patients expect fewer privacy protections because of the intimate ties binding care providers with entities with an interest in private patient data.56 some of these settings are characterized by special links between health care providers and other third parties. known as “dual loyalty,” health care providers’ split commitment or “simultaneous obligation to a patient and a third party” presents a number of challenges.57 this includes obligations to third party payers, state actors, and other institutional parties. in most egregious cases, dual loyalty may lead to patient abuses and rights violations, such as coerced medical or mental health treatment.58 overall, balancing state, community, payer, and individual interests continues to be a hotly contested area,59 and is highly dependent on a society’s cultural, economic, and legal contours. the u.s. has a long and complicated history of public health surveillance. dating back to the early days of the republic and substantially evolving during the late 19th and early 20th centuries, public health surveillance systems have typically emerged in response to real or perceived public health crises, such as yellow fever.60 typically intended to identify emergent threats, target interventions and inform policy responses, they are also often conceptualized as deterrents to undesirable behavior. by and large, these monitoring and surveillance systems 54. fairchild et al., supra note 49, at 510. 55. the recent ebola crisis represents an example of how the lack of adequate protections for patient right for confidentiality can adversely impact public health. in many of the affected locales, cases of infection quickly became public knowledge, leading to devastating consequences to both individuals and their families and neighbors. in response, infected individuals were often hidden for the fear of being ostracized and did not seek help until it was too late and their caregivers had been put at an unnecessary risk of infection. see, e.g., fear, politics, and ebola: how quarantines hurt the fight against ebola and violate the constitution, am. civil liberties union & yale glob. health j. p’ship (2015), https://law.yale.edu/system/files/ documents/pdf/intellectual_life/aclu_yale_ghjp_-_fear_politics_and_ebola-december_2015.pdf [https://perma.cc/dlg3-665t]. 56. see engelhardt, jr., supra note 26, at 339-40. 57. see international dual loyalty working group, supra note 30, at 11. 58. see, e.g., policing patient privacy, propublica, https://www.propublica.org/series/ patient-privacy# [https://perma.cc/npc3-f76b]. 59. see generally mariner, supra note 24. 60. stephen b. thacker et al., public health surveillance in the united states: evolution and challenges, ctrs. for disease control & prevention at 3-9 (2012), https://www.cdc.gov/ mmwr/pdf/other/su6103.pdf [https://perma.cc/d7db-wlrh]. 2018] deploying prescription drug monitoring 149 have used health care encounters as their sentinel points of data collection, mandating providers to report confidential data without patient consent in instances of a whole range of instances ranging from suspected child abuse to gunshot wounds to sexually-transmitted diseases and, at one time, abortions.61 just as with other forms of government surveillance, public health surveillance can be both “vital to the maintenance of our welfare” and “a policy of rounding undesirable” citizens.62 the history of mandated disclosure programs in the u.s. and elsewhere is marked by a steady march towards more comprehensive, systematic, and effective surveillance. the dual-edged view of surveillance also means that its development has been shaped by the parallel evolution of privacy as american “society’s limiting principle,”63 especially its emergence as a normative consideration and legal construct in jurisprudence and political thought.64 throughout the decades, public health surveillance has periodically invoked privacy concerns, closely tied to the abuse, over-reach, and stigmatization it potentiated.65 in instances exemplified by the vociferous advocacy of the citizens’ council on health care against birth defect registries, such concerns may have been principally theoretical.66 they have been spurred by general distrust in government and libertarian sentiment.67 conversely, episodes like the tuskegee syphilis study fueled well-founded suspicion of public health surveillance efforts in african americans and other minority groups,68 people living with hiv/aids,69 gay men,70 as well as undocumented immigrants.71 61. see whalen v. roe, 429 u.s. 589, 602 (1977); see also planned parenthood of cent. missouri v. danforth, 428 u.s. 52, 79-81 (1976) (upholding the constitutionality of missouri’s abortion registry). 62. james scott, seeing like a state: how certain schemes to improve the human condition have failed 4 (yale u. press 1998). 63. laurence tribe, american constitutional law 1302 (foundation press, 2d ed. 1988). 64. fairchild et al., supra note 49, at 23-25. 65. id. 66. id. at 164-65 (noting that minnesota department of public health found themselves embroiled in an unanticipated political dispute concerning their prospective implementation of a birth defect registry in the 1990s. though the surveillance system was introduced as a public health response to heightened pesticide exposure in children, political advocacy groups such as the citizens’ council on health care capitalized on social anxieties and historical concerns about patient privacy to launch a formidable counter-campaign against the measure. consequently, public health officials eventually withdrew their proposal, despite the state’s rising rates in pesticiderelated birth defects.). 67. id. 68. id. at 68-69. 69. id. at 194-95 (describing a 1986 incident in florida, where the hiv positive status of thousands of patients was widely disclosed). 70. id. at 197-99. 71. id. 150 indiana health law review [vol. 15:139 these concerns included consideration of how class, social status, and racial characteristics of affected patients affected the implementation and “politics of surveillance.”72 b. pdmps as a tool of public health surveillance the emergence of prescription drug monitoring programs reflects the evolution of disease-related surveillance in the us. in fact, efforts to track prescription of potentially-addictive medications date back to the early 1900s, including legislation like the harrison narcotics act,73 which set minimum standards for recording and reporting prescription of certain opioid medications. steeped in drug panics of the era with roots in anti-immigrant sentiment,74 this legislation cemented federal government jurisdiction of prescription and pharmacy practice in the space that would become known as “controlled substances.”75 in the intervening years,76 the tracking of prescription medications deemed at high risk of misuse was accomplished primarily through the requirement of a triplicate prescription form, with one form being given to the patient, another being retained on file with the pharmacy, and the third being sent to a relevant government agency. the history of modern-day pdmps dates back to the 1960s and 1970s. renewed legislative interest in these programs reflected emerging concerns about substance misuse among soldiers returning from vietnam77 and changes wrought by the countercultural movement. during this era of panic over drug use, new legislation expanded both the scope and the tools of surveillance.78 the simultaneous advent of computer-assisted pdmps occurred just as public health surveillance79 was making its transition into the digital age.80 72. id. 73. 38 u.s.c. § 785 (1914). 74. deborah ahrens, drug panics in the twenty-first century: ecstasy, prescription drugs, and the reframing of the war on drugs, 6 alb. gov't l. rev. 397 (2013). 75. joe spillane & william b. mcallister, keeping the lid on: a century of drug regulation and control, 70 drug & alcohol dependence s5 (2003); david f. musto, the american disease: origins of narcotic control (yale u. press 1973). 76. the first three states to pass pdmps were california (1939), hawaii (1943), and illinois (1958). 77. lee n. robins et al., drug use by u.s. army enlisted men in vietnam: a follow-up on their return home, 99 am. j. epidemiology 235, 235-49 (1974). 78. fairchild et al., supra note 49, at 25-27. 79. william phillips, kurt gorwitz, & anita k. bahn, electronic maintenance of case registers, 77 pub. health reps. 503, 503-04 (1962). 80. fairchild et al., supra note 49. states adopting pdmps during this era also included pennsylvania and new york (1972), and rhode island (1978). see karen blumenschien et al., review of prescription drug monitoring programs in the united states (2010), h t tp : / / ch f s .ky.gov/n r /rdon lyres /8 5 9 8 9 8 2 4 -1 030-4aa6-91e1-7f9e3ef68827/0 / kasperevaluationpdmpstatusfinalreport624 [https://perma.cc/v3z6-4c85]. 2018] deploying prescription drug monitoring 151 the emergence of the early modern pdmp is also closely enmeshed with the passage of sweeping drug control reforms, especially federal controlled substances act (csa).81 this law would also become the model state-level drug control framework. in 1970, congress adopted this legislation with the express purpose of “conquer[ing] drug abuse and . . . control[ling] the legitimate and illegitimate traffic in controlled substances.”82 this framework aimed to establish a “comprehensive” system to control the supply of drugs deemed potentially addictive or otherwise able to be abused.83 critical to this closed system is the articulation of a schedule, which categorizes drugs based on potential for abuse, accepted medical use, and likelihood of psychological or physical dependence.84 overtime, the scope of state pdmp laws adopted federal or state csa scheduling frameworks by training their surveillance efforts on specific drug schedules (typically schedules ii-v). during this same era, the construct of patient privacy and autonomy saw substantial expansion. emerging jurisprudence, epitomized in the progression from griswald v connecticut in 1965 to roe v wade in 1973, cemented the evolving understanding of privacy’s constitutional underpinnings.85 notably, both of these landmark privacy cases addressed disputes arising from highly-sensitive medical procedures, with griswald specifically invoking the patient’s autonomy in controlling their prescription drug choices.86 this jurisprudence set expanded pdmp laws and programs on a collision course with the emergent constitutional conceptualization—and public yearning for—privacy rights. spurred by anxiety about novel electronic database systems, this tension would come to a head in the watershed pdmp case whalen v. roe.87 at issue in whalen was the 1972 passage of a new york state (nys) provision directing the department of health to electronically document basic information for any patient prescribed a schedule ii medication.88 in contrast to existing nys paper-based prescription reporting, the new system would enable more practicable data management and streamlined analytical capability. this novel capability was aimed at identifying possible cases of drug diversion among patients and flagging patterns of potential inappropriate practices among prescribers.89 notably, this reform was part of a broad array of legislation buoyed by a wave of “get tough” ideology on drugs, exemplified by the highly-punitive rockefeller drug laws.90 a group of concerned citizens joined by health care providers challenged the 81. 21 u.s.c. § 801 et seq. 82. gonzales v. raich, 545 u.s. 1, 12 (2005). 83. 21 u.s.c. §§ 841(a)(1), 844(a) (1970). 84. 21 u.s.c. § 812 (1970). 85. tribe, supra note 63. 86. fairchild et al., supra note 49, at 22-23. 87. whalen v. roe, 429 u.s. 589 (1977). 88. id. 89. id. 90. fairchild et al., supra note 49, at 25. 152 indiana health law review [vol. 15:139 law. they sought to set minor constraints to state police power to store and collate data using new computerized tools. one plaintiff—a mother—claimed she had taken her child off ritalin to avoid him being “branded for life.”91 other adult plaintiffs recounted foregoing pain medication for the fear of being “labelled an addict,” especially disquieting at a time when nixon’s “public enemy number one” rhetoric was stoking the war on drugs.92 after being initially upheld93 the law was later struck down after the case was remanded on appeal.94 balancing low actual system utilization at the time of the trial with the law’s potential to violate “the most sensitive physical and psychological sensibilities” of patient privacy, the court struck down the new pdmp law.95 bucking its favorable disposition in privacy jurisprudence, the burger court reversed.96 it deemed weighing program value against possible privacy violations a legislative, not a judicial matter. brushing off these existential considerations, the court opined that the state police power entitled new york state to rationally “experiment with new techniques of [drug] control.”97 it further rationalized that the risk of harmful data disclosure through a subpoena was too “remote” to invalidate the entire state regulatory scheme—a scheme, it pointed out, analogous to two other states and any number of existing new york state patient reporting mechanisms.98 by articulating that “privacy” has multiple meanings, and that case law relating to autonomy in decision making did not apply to all matters of confidentiality,99 whalen demarcated the limits of privacy-based objections to government surveillance in modern jurisprudence. its broad recognition of state police power to collect and store large amounts of information formed the basis for controversial surveillance programs in the intervening decades.100 in rejecting to implicate surveillance program utility and impact, the court left the design and configuration of these surveillance programs generally (and pdmps in particular) a difficult target for legal challenge. in the context of the ideological discourse that captivated legislatures during the dawn of the war on drugs, this implicit endorsement set the stage for the later expansion and intensification of pdmps in the context of the overdose crisis. 91. id. at 26. 92. id. 93. id. 94. id. 95. id. 96. id. 97. whalen v. roe, 429 u.s. 589, 598 (1977). 98. id. at 601-02. 99. id. at 599-602. 100. see fairchild et al., supra note 49 (describing the impact of whalen and how upholding this public health surveillance as constitutional laid the groundwork for more extensive surveillance programs in later years), and at 246-50 (describing the social and political pressure following september 11, 2001 to increase national public health surveillance methods in order to prepare for bioterror attacks). 2018] deploying prescription drug monitoring 153 iii. pdmps in the age of the overdose crisis starting in around 2000, the us began to see steep increases in drug-related deaths, many involving opioid analgesics along with other depressants like benzodiazepines and alcohol.101 this has evolved into one of most devastating public health crises in its recent history. after rising at around 10% per year between 1999 and 2006, the overdose rate precipitously accelerated to 18% between 2014 and 2016. over 64,000 americans were killed by drug overdose in 2016—an unprecedented increase of more than 300% since the turn of the century.102 the death rate specifically attributable to synthetic drugs like fentanyl shockingly doubled just within a one-year period, from 2015 to 2016. the grim toll of overdose-related death and disability is propelled primarily by opioids. a drug family that includes both prescription analgesics and street drugs like heroin, opioids contribute to an average of well over 100 americans fatalities every day. the human toll of this crisis has impacted countless families,103 communities, and businesses; its financial costs already number in tens—perhaps hundreds—of billions per year.104 in order to understand this crisis, it is first useful to provide an overview of its key elements and evolution. a. opioid overdose, defined opioids kill by depressing the individual’s central nervous system, which in turn slows respiration.105 this process can take up to 90 minutes or longer.106 in lay discourse, overdose is often conflated with opioid addiction. a small but significant (up to 8%)107 prescription drug users develop substance use disorder 101. see dasgupta et al., supra note 6. 102. overdose death rates, nat’l inst. on drug abuse (sept. 2017), https://www. drugabuse.gov/related-topics/trends-statistics/overdose-death-rates [https://perma.cc/n7r3-fx95]. 103. in a recent poll, 56% of respondents, across all demographics, reported a personal connection to someone who has abused prescription painkillers. 63% of white-identifying respondents reported a personal connection, a rate higher than any other racial group. most americans report a personal connection to those who have abused prescription painkillers; whites more likely to be affected than blacks or hispanics, kaiser family found. (nov. 24, 2015), https://www.kff.org/health-reform/press-release/most-americans-report-a-personalconnection-to-those-who-have-abused-prescription-painkillers-whites-more-likely-to-be-affectedthan-blacks-or-hispanics/ [http://perma.cc/m82e-85dc]. 104. phillip o. coffin & sean d. sullivan, cost-effective of distributing naloxone to heroin users for lay overdose reversal variation in the delivery of health care: the stakes are high, 158 annals of internal med. 866 (2013). 105. scott burris, leo beletsky, carolyn castagna, casey coyle, colin crowe & jennie mclaughlin, stopping an invisible epidemic: legal issues in the provision of naloxone to prevent opioid overdose, 1 drexel l. rev. 273, 274-76 (2009). 106. id. 107. mark j. edlund et al., the role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription, 154 indiana health law review [vol. 15:139 (as “addiction” is referred to in clinical discourse),108 translating to increasing prevalence of risky non-medical use, such as snorting or injecting crushed pills. ultimately, it is not possible to ascertain what proportion of overdose victims would have met the diagnosis of severe substance use disorder. what we do know is that addiction is not the sole risk factor for a fatal overdose. polydrug use, especially the kind of mixing of opioids with other depressants like benzodiazepines, vastly increases overdose risk; doubling with every illicit drug consumed in combination with opioids.109 another critical driver of risk for overdose is resuming drug use after periods of voluntary or forced abstinence.110 such abstinence could result from drug “detoxification” or other treatment, incarceration, or other factors. upon resuming drug use, individuals’ overdose risk skyrockets because of loss of tolerance to the drug; when an individual consumes a dose similar to what they had used prior to incarceration, the loss of tolerance can render that dose fatal.111 in the case of incarceration, during the first month of re-entry, ex-prisoners’ risk of overdose is magnitudes higher than the background rate.112 the opioid antidote naloxone reverses the respiratory depression, reviving the victims regardless of setting.113 naloxone is a prescription medication, although states have adopted legal strategies to facilitate its lay distribution amidst calls to make this drug available over the counter.114 30 clinical j. pain 557 (2014) (finding the rate of substance use disorder among pain patients on high dose opioids is roughly 6%); nora d. volkow & a. thomas mclellan, 374 new eng. j. med. 1253 (2016) (underscoring the need for some patients to remain on opioids, citing fewer than 8% of pain patients develop substance use disorder). 108. see diagnostic & stat. manual of mental disorders (dsm-5) (2015). 109. world health org., prevention of acute drug-related mortality in prison populations during the immediate post-release period 10 (2010). 110. ingrid a. binswanger et al., release from prison—a high risk of death for former inmates, 356 new eng. j. med. 157, 160-61 (2007). among washington state prisoners, overdose mortality risk was elevated twelve-fold compared to similar demographic groups within the general population; see also p.b. christensen et al., mortality among danish drug users released from prison, 2 int’l j. prisoner health 13, 13-19 (2006); michael farrell & john marsden, acute risk of drug-related death among newly released prisoners in england and wales, 103 addiction 251, 252-54 (2007). 111. edle ravndal & ellen j. amundsen, mortality among drug users after discharge from inpatient treatment: an 8-year prospective study, 108 drug & alcohol dependence 65 (2010). 112. binswanger et al., supra note 110, at 157, 160-61; see also mass. dep’t of pub. health, an assessment of opioid-related deaths in massachusetts (2013–2014) 38 (sept. 2016), http://www.mass.gov/eohhs/docs/dph/stop-addiction/dph-legislative-report-chapter-55opioid-overdose-study-9-15-2016.pdf [https://perma.cc/96w3-nh3a] (estimating postincarceration risk at 650 times the background rate). 113. leo beletsky, josiah d. rich & alex y. walley, prevention of fatal opioid overdose, 308 jama 1863 (2012). 114. id. at table 1. see also leo beletsky, the benefits and potential drawbacks in the approval of evzio for reversal of opioid overdose, 48 am. j. preventative med. 357, 357-59 2018] deploying prescription drug monitoring 155 b. the ideology of opioid response: focus on the drug supply as the vector for decades, opioid overdose had been endemic in urban communities of color, pockets of deep poverty in appalachia, and other limited settings.115 aside from periodic celebrity deaths and occasional spikes in fatalities among heroin users related to fluctuations in drug purity, overall prevalence of opioid overdose remained relatively constant; so did public apathy.116 stigma attached to illicit drug use and reinforced by criminal law—as well as class and racial prejudice—translated to the lack of any concerted public health response. this endemic phase of apathy would gradually come to an end as the sheer magnitude, geography and demographics—its “changing face”—would begin to attract the mainstream attention it now so consistently receives.117 the commonplace story about the current overdose crisis—both among professional and lay observers—is a narrative based on what in public health is referred to as the “vector model of disease.” rooted in the customary public health concern with infection control, this theory frames opioid drugs as a contagion. as with a virus, exposure to the opioid supply carries a risk of disease and even death.118 similarly, opioid fatalities have rapidly spread regionally and even internationally in a short period of time. this framing helps explain the wide popularity of the term “epidemic” to describe a crisis. the vector model narrative proceeds as follows: towards the end of the twentieth century, american medicine was shocked by a series of epiphanies about the appalling societal levels of under-treated pain. this launched a wellintentioned drive to improve its management. pain became the “fifth vital sign” and its self-assessment was introduced as a measure of consumer satisfaction, with implications for health care facilities’ ratings and accreditation.119 a movement towards “patient-centeredness” also catalyzed health care providers’ focus on patient comfort and satisfaction. sensing a business opportunity, several drug makers engaged in aggressive physician detailing and other marketing to assuage concerns about the risks of (2015). 115. theodore j. cicero et al., the changing face of heroin use in the united states: a retrospective analysis of the past 50 years, 71 jama psychiatry 821 (2014). 116. see burris et al., supra note 105, at 273-75 (discussing the relative apathy of the general public towards opioid overdose, despite the relative frequency in deaths of celebrities struggling with heroin use). 117. julie netherland & helena b. hansen, the war on drugs that wasn’t: wasted whiteness, “dirty doctors,” and race in media coverage of prescription opioid misuse, 40 culture, med., & psychiatry 664 (2016); theodore j. cicero et al., supra note 115. 118. see generally dasgupta et al., supra note 6 (interrogating the application of the vector model to the overdose crisis). 119. jane c. ballantyne & mark d. sullivan, intensity of chronic pain—the wrong metric?, 373 new eng. j. med. 2098 (2015). 156 indiana health law review [vol. 15:139 dependence, addiction, and overdose inherent to opioid therapy.120 this included the creation of astro-turf “patient rights” groups that would use legitimate gaps in patient care to advance the agenda of the pharmaceutical industry. some of these initiatives intentionally misled prescribers about risks by asserting, without much evidence, that new product formulations successfully minimized adverse side effects in treatment of chronic pain.121 these developments drove a rapid expansion in the availability of opioid analgesics. prescribers readily relied on these medications to treat all kinds of pain, including acute, chronic, and palliative indications. prescriptions were often made for medication courses that were substantially longer than necessary—epitomized in the narratives featuring high school athletes receiving a thirty-day oxycontin supply for a sprained ankle.122 in addition to those acting in good faith, a small proportion of providers established “pill mills,” which issued opioid prescriptions with inadequate regard for the patients’ actual medical need. as a result, the rate of opioid analgesic consumption more than tripled between 1999 and 2006123 but leveled off and started to decline after 20112012.124 with steep increases in exposure to these powerful depressants, the number of americans experiencing accidental opioid poisonings began to grow.125 this has been attributed to the inherent habit-forming properties of these drugs and to the poor understanding of how to properly balance appropriate pain care with the risk of addiction and overdose. ultimately, the rising popularity of opioid analgesics was closely trailed by an upward curve in opioid overdose fatalities.126 120. francis b. palumbo & c. daniel mullins, the development of direct-to-consumer prescription drug advertising regulation, food & drug l. j. 423 (2002). 121. ironically, the same pitch was used to market heroin when it was first formulated by bayer laboratories as a less addictive form of morphine. 122. l. jon wertheim & ken rodriguez, how painkillers are turning young athletes into heroin addicts, sports illustrated (june 18, 2015), https://www.si.com/moresports/2015/06/18/special-report-painkillers-young-athletes-heroin-addicts [http://perma.cc/bc4jxb3w]; kenneth craig & polly leider, the surprising path from student athlete to heroin addict, cbs news (mar. 2, 2016, 5:30 pm), https://www.cbsnews.com/news/student-athletes-on-painkillers-at-risk-for-heroin-addiction/ [https://perma.cc/82ec-vsuk]. 123. li-hui chen et al., rates of deaths from drug poisoning† and drug poisoning involving opioid analgesics§ — united states, 1999–2013, morbidity & mortality weekly report (jan. 16 , 2015), h t tps:/ /www.cdc.gov/mmwr/preview/mmwrhtml/mm6401a10 .h tm [https://perma.cc/3ccl-g9a5] 124. id. see also gery p. guy jr. et al., vital signs: changes in opioid prescribing in the united states, 2006–2015, morbidity & mortality weekly report (july 7, 2017), https://www.cdc.gov/mmwr/volumes/66/wr/mm6626a4.htm [https://perma.cc/mm2w-sx2g]; edmund j. pezalla, secular trends in opioid prescribing in the usa, 10 j. pain res. 383 (2017). 125. hedegaard et al., supra note 1. 126. li-hui chen et al., drug-poisoning deaths involving opioid analgesics: united states, 1999–2011, nat’l ctr. health stats data brief no. 166 (sept. 2014) http://europepmc.org/ abstract/med/25228059 [https://perma.cc/56jg-2v4p]. 2018] deploying prescription drug monitoring 157 around 2010, the second phase of the crisis began to take shape. after remaining stable for years, overdose deaths involving heroin spiked rapidly, tripling between 2010 and 2015.127 the “vector model” associates this shift with rising rates of addiction among those taking opioid medications; once the users were exposed and seeking an ever-elusive high, prescription opioids would then act as a “gateway” to black market drugs, based on their ubiquitous availability and lower price relative to diverted prescription medications. this narrative is encapsulated in the often-cited statistic that “4 out of 5 new heroin users started with prescription drugs.128 starting in 2014, the crisis spiraled into its third phase. black market drugs—including heroin and counterfeit pills—became increasingly adulterated with illicitly-manufactured synthetic opioids, mainly fentanyl analogues.129 these substances can be clandestinely synthesized cheaply and with relative ease by anyone with the requisite knowledge of—and access to—chemical laboratory equipment. in the span of a single year, from 2014 to 2015, u.s. deaths attributed to fentanyl analogues spiked by over 72% to almost 10,000.130 in an increasing number of locales, these clandestinely-manufactured synthetics now constitute the primary drivers of fatal opioid poisoning.131 under the vector model, the fault for this uncontained crisis falls principally—and almost exclusively—on the substances and their distributors. were it not for the unenlightened or unscrupulous behavior by health care providers and drug companies, this line of logic suggests we would not be in the situation we are in today. this logic certainly applies to contaminated food products.132 however, aside from their habit-forming properties, opioids provide, powerful relief to sufferers of physical and emotional pain—which is the reason they have remained a critical healing tool for centuries.133 even a cursory 127. rose a. rudd et al., increases in drug and opioid-involved overdose deaths–united states, 2010-2015, morbidity & mortality weekly report (dec 30, 2016), https://www.cdc. gov/mmwr/volumes/65/wr/mm655051e1.htm?mbid=synd_yahoohealth&s_cid=mm655051e1_w [https://perma.cc/aq4t-yaat]. 128. heroin, nat’l inst. on drug abuse (july 2017), https://www.drugabuse.gov/ publications/drugfacts/heroin [https://perma.cc/5jmf-azwc]. 129. sheila kaplan, c.d.c. reports a record jump in drug overdose deaths last year, n.y. times (nov. 3, 2017) https://www.nytimes.com/2017/11/03/health/deaths-drug-overdosecdc.html?_r=0 [https://perma.cc/gjw2-37jr]. 130. rudd, supra note 127. some of this increase may have been caused by broader awareness and better surveillance of the problem. 131. mass. dep’t of pub. health, supra note 112. see also denise paone, unintentional drug poisoning (overdose) deaths involving heroin and/or fentanyl in new york city, 2000-2015 (2016). 132. multistate outbreak of listeriosis linked to soft raw milk cheese made by vulto creamery (final update), ctrs. for disease control & prevention (may 3, 2017, 1:30 pm), https://www.cdc.gov/listeria/outbreaks/soft-cheese-03-17/index.html [https://perma.cc/h7d4qhtn]. 133. id. 158 indiana health law review [vol. 15:139 examination of the demographic, epidemiological and economic evidence limits the explanatory power of the vector model as it applies to the overdose crisis. c. the social determinants critique although it is a common refrain to say that the overdose crisis cuts across geographic and demographic fault lines, not all racial and economic groups have been uniformly affected. areas and groups characterized by poverty, concentrated disadvantage, and poor economic opportunity have been noted to be at much higher risk.134 these statistics readily point to more fundamental underlying causes of the crisis. modern public health embraces economic, social, and other “structural” factors as “social determinants” of health.135 central to the social determinants framework is the recognition of wide disparities in health.136 although some differences in health outcomes may be due to biological factors (for example, life expectancy differences between the sexes), observed differences in disease prevalence and life expectancy based on racial, class, geographical and other arbitrary characteristics vividly demonstrate the influence of structural factors.137 in addition to clear links between poor health and low economic attainment, inequality in-and-of-itself appears to play a role in generating stress, substance misuse, and other disease-causing processes.138 a deeper exploration of the relationship between structural determinants, pain, addiction, and overdose has been covered elsewhere139 and is beyond the scope of this paper. what is critical to the discussion of the role of pdmps in the response to the current crisis is that there is ample evidence pointing to the importance of social, economic, health care systems, and other factors as the drivers of drug use and overdose crisis.140 so, while the expansion in the availability of prescription analgesics certainly played a role in facilitating this crisis, an exclusive focus on that expansion misses its underlying root causes. an emerging domain of demographic research into “diseases of despair” helps to better understand the broader phenomena that precipitated the current overdose emergency. coined by princeton economists anne case and angus deaton, this term refers to the interconnected trends in fatal drug overdose, alcohol-related disease, and suicide. since 1999, age-specific mortality attributed 134. see infra notes 139-40 and accompanying text. 135. see parmet, supra note 21. 136. id. at 53-54; see also katherine unger davis, racial disparities in childhood obesity: causes, consequences, and solutions, 14 u. pa. j. l. & soc. change 313, 333 (2011). 137. david s. jones et al., the burden of disease and the changing task of medicine, 366 new eng. j. med. 2336 (2012). 138. rick mayes & thomas r. oliver, chronic disease and the shifting focus of public health: is prevention still a political lightweight?, 37 j. health pol., pol’y, & law 181 (2012). 139. johann hari, chasing the scream: the first and last days of the war on drugs (bloomsbury 2015). 140. see dasgupta et al., supra note 6. 2018] deploying prescription drug monitoring 159 to “diseases of despair” has seen an “extraordinary” and “unanticipated” rise previously rarely seen in times of peace.141 based substantially on these three causes of death, middle-aged white americans without a bachelor’s degree now have a lower life expectancy than their parents.142 the “reversal of fortunes”143 in life expectancy originally identified in underserved counties of appalachia and the southwest in the first decade of the 21st century now characterizes the overall demographic trend for the united states.144 alcohol-related liver disease and—to a substantial degree—suicide are not directly attributable to the risks posed by opioid medications. alarming upward trends in those realms challenge the centrality of opioid supply as the root cause of the overdose crisis.145 case and deaton attribute these unprecedented demographic shifts to deterioration in economic and social factors, linked primarily to the stagnation in real wages, decline in economic opportunity, and the economic shocks following the 2008 financial crisis.146 ultimately, they argue, these drastic demographic shifts are linked to cumulative deprivation following a long-term process of decline. this has culminated in the loss of hope for a better future that has hit white working-class americans especially hard. austerity politics have accelerated these trends.147 in a wave of political 141. anne case & angus deaton, mortality and morbidity in the 21st century, brookings panel on econ. activity conference 8 (mar. 17, 2017), https://www.brookings.edu/wpcontent/uploads/2017/03/6_casedeaton.pdf [https://perma.cc/z3f4-xrqa]. 142. id. see also majid ezzati et al., the reversal of fortunes: trends in county mortality and cross-county mortality disparities in the united states, plosmedicine (april 22, 2008) h ttp:/ / journals.plos.org/plosmedicine/art icle?id=10 .1371/journal.pmed.0050066 [https://perma.cc/v8wk-93wb] (noting that mortality rates of whites with no more than a high school degree, which were around 30% lower than mortality rates of blacks in 1999, grew to be 30% higher than blacks by 2015). 143. ezzati et al., supra note 142 (stating that ultimately, disparities are responsible for reversing overall life expectancy gains made in the last century). 144. case & deaton, supra note 141, at 12 (“the epidemic spread from the southwest, where it was centered in 2000, first to appalachia, florida and the west coast by the mid-2000s, and is now country-wide.”). 145. anne case & angus deaton, rising morbidity and mortality in midlife among white nonhispanic americans in the 21st century, 112 proc. nat’l acad. of sci. of the u.s. 15078 (2015), http://www.pnas.org/content/112/49/15078.full [https://perma.cc/8p2x-88re]. 146. see id. this paper has not been peer reviewed, but it fits with a broader literature on “reversal of fortunes” for large swaths of us population in terms of health outcomes tied to economic and other factors. 147. arne ruckert & ronald labonté, health inequalities in the age of austerity: the need for social protections policies, 187 soc. sci. & med. 306 (aug. 2017) (arguing that paradoxically, divestment and dismantling of the social safety net has rendered governments on all levels illequipped to provide meaningful and effective protection from major community threats. regulated industries have seized on this opportunity to advance policies based on laissez-faire economic principles. ironically, the downward spiral in investment and regulation has fueled libertarian movements like the tea party. in the u.s., this has culminated with the surprise victory of trump 160 indiana health law review [vol. 15:139 pressure to cut costs, governments on all levels of the u.s. federalist structure have failed to invest in prevention, basic services, and economic resilience.148 they have also failed to address deep structural issues that have fueled the crisis, eroding perceived utility of collective responses to societal challenges. paradoxically, this frustration propelled to victory politicians espousing increasingly more austere policies.149 in view of the broader uncertainty, declining opportunity, and other societal stressors, opioids are singular in their ability to provide fast, effective, and relatively cheap analgesia, be it from physical and psychological trauma. if we recast “pain” as inclusive of economic stress, social isolation, and other structural trends, the role of opioids as symptomatic of neglected societal problems begins to come into focus.150 other, more proximal structural contributors to the opioid crisis are also clearly important. this includes the architecture and function of the health care system. far beyond merely acting as a potential source of harmful exposure to opioid drugs, health care can have a protective effect against precursors to opioid misuse and overdose; this includes provision of effective and accessible pain care, mental health care, and risk-reduction interventions for individuals with substance use disorder.151 yet, the u.s. health care system and its providers are unprepared to meet many of these challenges. utilization of psychoactive medications other than opioids--including benzodiazepines--has literally skyrocketed in the last two decades, underscoring over-reliance on risky pharmacotherapy to address complex psychosocial challenges.152 limited physician understanding of substance use disorder is well-documented: very few providers receive adequate training in this realm (although this may be changing).153 substance use screening and other risk reduction interventions are not systematic and may be disincentivized by insurance architecture, lack of enforcement of legal mandates such as mental health and substance use coverage parity, and other financial and handing republican control of all three branches of the federal government, along with the overwhelming majority of governorships and state legislatures). 148. id. see also david stuckler & sanjay basu, the body economic: why austerity kills (basic books 2013). 149. id. 150. see dasgupta et al., supra note 6, at 184-85. 151. sarah bowman et al., reducing the health consequences of opioid addiction in primary care, 126 am. j. med. 565 (2013). 152. maia szalavitz, the mystery of the terrifying xanax resurgence in america, vice news (mar. 28, 2018), https://www.vice.com/en_us/article/paxg39/the-mystery-of-the-terrifying-xanaxresurgence-in-america [https://perma.cc/9rq4-y72k] (noting the eight-fold rise in benzodiazapinerelated overdose since the start of the 21st century and the relationship to deaths of despair structural cause framework). 153. colum. u. nat’l ctr. on addiction & substance abuse, missed opportunity: national survey of primary care physicians and patients on substance abuse (apr. 2000), http://files.eric.ed.gov/fulltext/ed452442.pdf [https://perma.cc/fw86-cac9]. 2018] deploying prescription drug monitoring 161 pressures.154 more generally, providers share general societal attitudes towards substance users as a difficult population not amenable to intervention.155 in addition, geographical barriers, inadequate health insurance coverage, and uneven distribution of medical resources may influence access to pain management services, preventative care, and substance use treatment.156 technical features like insurance pre-authorization requirements, coverage limitations, and provider compensation rates can substantially shape what care is provided, and to whom.157 gaps in care can induce self-medication (for pain, as well as for drug withdrawal symptoms) and contribute to overdose risk. for instance, nationwide, access to evidence-based substance use treatment—a critical tool in the fight against opioid overdose—is available only to an estimated onein-ten patients who require it.158 in about one third of us states, including some of the hardest-hit jurisdictions, state medicaid policies prohibit coverage of methadone—a lifesaving maintenance medication that can cut overdose risk by over 50%.159 the extent to which these and other protective functions of health care are accessible, appropriate, affordable, and of high quality are critical determinants of opioid overdose risk. finally, the demand for pain relief is often a function of the individual’s overall health. consider the example of obesity. individuals who meet the definition of obesity are much more likely to suffer from other chronic health 154. uncovering coverage gaps: a review of addiction benefits in aca plans, nat’l ctr on addiction & substance abuse (june 2016), https://www.centeronaddiction.org/ download/file/fid/1678 [https://perma.cc/3y28-gxqr]. 155. lin ding et al., predictors and consequences of negative physician attitudes toward hiv-infected injection drug users, 165 arch. intern. med. 618, 618-23 (mar. 28, 2005); see also leo beletsky et. al., physicians’ knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities, 84 j. urb. health 126-37 (2007). 156. colleen galambos, health care: overview, encyc. of soc. work (2014) http://socialwork.oxfordre.com/view/10.1093/acrefore/9780199975839.001.0001/acrefore9780199975839-e-549 [https://perma.cc/33mx-fhf4]. 157. zachary siegel, we know how to treat opioid addiction, slate (nov. 30, 2016, 9:17 am), http://www.slate.com/articles/health_and_science/medical_examiner/2016/11/ we_do_not_use_an_evidence_backed_method_for_treating_heroin_addict ion .html [https://perma.cc/bz2j-kztc] (arguing that pre-authorization and other bureaucratic obstacles causes a lack of access to lifesaving drugs like methadone and buprenorphine). 158. dep’t of health & human servs., office of the surgeon general, facing addiction in america: the surgeon general’s report on alcohol, drugs, and health 1-3 to 1-25 (2016). 159. christine vestal, still not enough treatment in the heart of the opioid crisis, pew charitable trusts (sept. 26, 2016), http://www.pewtrusts.org/en/research-and-analysis/blogs/ stateline/2016/09/26/st ill-not-enough-treatment-in -the-heart-of-the-opioid-crisis [https://perma.cc/d8cf-8g45] (noting that “west virginia is one of the 17 states where medicaid does not pay for methadone, and it has had an adversarial relationship with methadone clinics for decades. methadone clinics weren’t allowed in the state until 2001, and after nine for-profit clinics set up shop in west virginia, the legislature in 2007 placed a moratorium on opening any more.”). 162 indiana health law review [vol. 15:139 problems, including chronic pain.160 rates of “overweight” and obesity have skyrocketed among americans in the last four decades.161 today, two thirds of american adults are overweight or obese.162 among well-documented “obesogenic” factors are the individual’s nutritional, informational, and built environment.163 to the extent that being overweight elevates one’s vulnerability to acute and chronic pain, the numerous environmental elements operative in obesity may factor into the structural equation for the overdose crisis. although far from exhaustive, this overview of the “structural determinants” framework helps illuminate the reality that the conditions for the overdose crisis have deep, tangled roots. only in embracing this complexity can we hope to craft appropriate, multi-pronged responses. to date, this conceptualization has seldom reflected the solutions and interventions that have been advanced to curb the crisis. d. the role of pdmps in overdose crisis response broadly speaking, the opioid crisis illustrates the folly of employing simple solutions to address complex problems. the crisis’ origins implicate health care providers’ over-reliance on opioid therapy for a broad set of health problems. in many cases, especially those involving patients with complex interactions of physical and mental health needs, opioids became an attractive go-to response to a range of physical and mental health complaints, including many cases where a highly-personalized and resource-intensive course of treatment would have been more appropriate.164 this resulted in temporarily assuaging patient symptoms and claiming success in metrics such as patient satisfaction surveys. over time, however, it became clear that the failure to apply more intensive and caseappropriate care up front caused considerable downstream complications.165 on the policy level, reducing the supply of prescription medications to solve the overdose crisis offers an analogous mirage of a simple solution to a complex challenge. this parallel appears to be lost on key decision-makers tasked with addressing the crisis. as deaths involving prescription painkillers have leveled off, the latest data on opioid-related fatalities could not be more dire. these 160. aiko okifuju & bradford d. hare, the association between chronic pain and obesity, 8 j. pain res. 399 (2015). 161. inst. of med., accelerating progress in obesity prevention 2 (2012); see also cynthia l. ogden et al., prevalence of childhood and adult obesity in the united states, 20112012, 311 jama 806, 806-07 (2014). 162. see inst. of med., accelerating progress in obesity prevention, supra note 161. 163. james o. hill et al., obesity and the environment: where do we go from here?, 299 sci. 853 (2003). over the last several decades, the nutritional value of food and beverages has shifted to higher simple sugar content. portions in retail and restaurant offerings have grown considerably. another notable aspect of the food environment is food and beverage advertising, which is pervasive and highly-targeted. 164. see dasgupta et al., supra note 6, at 184-85. 165. id. 2018] deploying prescription drug monitoring 163 deaths have quadrupled between 2000 and 2013,166 doubling just between 2010 and 2012.167 they have experienced another, even more shocking recent spike, largely related to fatalities caused by illicitly-manufactured fentanyl.168 this is because the trends in prescription painkiller and heroin use are linked. there is substantial evidence169 to suggest that the crisis is being fueled by the crackdown on painkillers like oxycontin and vicodin. shuttering pill-mills, tightening restrictions on certain analgesics, and making products harder to snort and inject seem to be curbing prescription drug use.170 but addiction does not simply go away when the pills do, which is why people dependent on prescription opioids have been switching to heroin in record numbers.171 from a chemical standpoint, heroin is very similar to its prescription drug cousins. its uncontained black market availability, increasing adulteration with the potent synthetics, and association with injection drug use make heroin a much more risky substance of choice.172 troubling emerging data indicate that an increasing proportion of users are now initiating opioid use with heroin, not with particular prescription drugs.173 these data underscore the fundamental reality that slashing opioid prescribing is unlikely to result in marked reductions 166. hedegaard et al., supra note 1. 167. matt sledge, heroin-linked deaths surge 39 percent, cdc finds, huffpost (jan. 12, 2015, 7:14 pm), http://www.huffingtonpost.com/2015/01/12/heroin-deaths-cdc_n_6459130.html [https://perma.cc/3csf-kv7k]. 168. katz, supra note 4. 169. see olga khazan, the new heroin epidemic, the atlantic (oct. 30, 2014), http://www.theatlantic.com/features/archive/2014/10/the-new-heroin-epidemic/382020 [https://perma.cc/x6sw-x4ej]. 170. gregory d. curfman, leo beletsky & ameet sarpatwari, benefits, limitations, and value of abuse-deterrent opioids, 178 jama internal med. 131 (2018). see also mark r. larochelle et al., rates of opioid dispensing and overdose after introduction of abuse-deterrent extendedrelease oxycodone and withdrawal of propoxyphene, 175 jama internal med. 1978 (2015); abby alpert et al., supply-side drug policy in the presence of substitutes: evidence from the introduction of abuse-deterrent opioids (nat’l bureau of econ. research, working paper no. 23031, 2017), http://www.nber.org/papers/w23031.pdf [https://perma.cc/e7lv-yjar]. 171. cicero et al., supra note 115. 172. nora d. volkow, america’s addiction to opioids: heroin and prescription drug abuse: hearing before s. caucus on international narcotics control, nat’l institute on drug abuse (may 14, 2014), http://www.drugabuse.gov/about-nida/legislative-activities/testimony-tocongress /2 0 1 4 /am er icas -add ic t ion -to -op io ids -h e ro in -presc ript ion-drug-abuse [https://perma.cc/2vv5-yept]. 173. theodore j. cicero et al., increased use of heroin as an initiating opioid of abuse, 74 addictive behav. 63 (2017) (“in 2005, only 8.7% of opioid initiators started with heroin, but this sharply increased to 33.3% (p<0.001) in 2015, with no evidence of stabilization. the use of commonly prescribed opioids, oxycodone and hydrocodone, dropped from 42.4% and 42.3% of opioid initiators, respectively, to 24.1% and 27.8% in 2015, such that heroin as an initiating opioid was now more frequently endorsed than prescription opioid analgesics.”). 164 indiana health law review [vol. 15:139 in overdose morbidity and mortality;174 unless we address the underlying health and structural factors driving demand, efforts to curb supply will simply result in an increasingly morbid game of whack-a-mole. nevertheless, to date, much of the discourse on the crisis continues to emphasize opioid supply. the zeal for supply reduction policies and programs has withstood a growing body of empirical and theoretical critique, much of which suggests that the application of these interventions was doing more harm than good.175 from the very early days of the overdose crisis, pdmps have served as the central feature in this ideologically-driven supply reduction paradigm. pdmps are now prominently featured176 by government agencies on all levels as a key weapon in the fight against the mounting overdose toll. if only we could get more prescribers and pharmacists to use these databases—the accepted wisdom goes—the overdose crisis could subside.177 this logic has spurred broad exuberance about the potential role of pdmps as a near-panacea in us response to the crisis, leading to the rapid expansion in the number, scope, and intensity of these programs. as of 2018, all fifty states and the district of columbia have authorized pdmps, up from only fourteen in 2000.178 these fifty-one systems are increasingly interoperable, thanks in part to federal grants authorized through the national all schedules prescription electronic reporting act (nasper), as well as other sources.179 interoperability is moving the patchwork system ever-closer to a national pdmp infrastructure conceptualized by nasper’s architects (but never funded by congress).180 174. see sally satel & stefan kertesz, pill limits are not a smart way to fight the opioid crisis, slate (mar. 30, 2018, 1:53 pm), https://slate.com/technology/2018/03/pill-limits-are-nota-smart-way-to-fight-the-opioid-crisis.html [https://perma.cc/6ntd-g39s] (describing the evidence that opioid prescribing reductions, including the 48% drop in high-dose prescriptions, has not resulted in significant changes in overdose deaths, including those from prescription medications). 175. id. (describing the likely harm that will result from trump administration’s proposals to slash opioid prescribing by 30% to address the overdose crisis). see, e.g., dan werb et al., the temporal relationship between drug supply indicators: an audit of international government surveillance systems, 3 bmj open e003077 (2013) (noting that heroin’s price has declined by 80% over the last three decades, while purity has increased more than two-fold). 176. opioid painkiller prescribing, ctrs. for disease control & prevention, http://www.cdc.gov/vitalsigns/opioid-prescribing/ [https://perma.cc/zng4-m2t5]. 177. jeanmarie perrone et al., medication reconciliation for controlled substances—an “ideal” prescription-drug monitoring program, 366 new eng. j. med. 2341 (2012). 178. see figure 1. 179. national all schedules prescription electronic reporting act (nasper), pub. l. no. 109-60, 119 stat. 1979 (2005); see also bureau of justice assistance, interim policy: allowable uses for harold rogers prescription drug monitoring program grant funds (mar. 21, 2012), https://www.bja.gov/programs/pdmpinterimpolicy.pdf [https://perma.cc/ n9re-2wlj]. 180. national all schedules prescription electronic reporting reauthorization act of 2016, s. 480, 114th cong. (2016). 2018] deploying prescription drug monitoring 165 theoretically, the creation of uniform and interoperable systems tracking prescription drug use creates the potential of benefit on a number of levels. such systems could play an important patient care function, including preventing dangerous drug interactions, monitoring medication adherence, streamlining care coordination among various providers, and identifying patients in need of additional care or services. in terms of their public health surveillance function, pdmps can help understand the prevalence and incidence of use of certain drugs, track unexpected or adverse events, and target resources and interventions to patients and geographical areas most in need. the centers of disease control lists many of these ideal functions and uses in its public guidance for the utilization of pdmps.181 but what is the actual express purpose stated by the programs themselves? reflecting the fact that these systems have roots as tools of law enforcement, many continue to characterize their principal function as to identify possible prescription drug misuse and diversion;182 this primarily addresses “doctor shopping” whereby a patient receives prescriptions from a number of different doctors for the exact same condition. in a systematic national analysis of language pdmps use to describe their own goals and functions, this “supply reduction-punitive” orientation was near-universal, with 83% of the forty-one analyzed programs.183 depending on a jurisdiction, additional goals such as balancing medication access, improving access to drug treatment, and supporting clinical decision making are also featured among the stated aims.184 demand reduction, mostly related to using pdmp data to facilitate patient access to substance use treatment was invoked by 51% of the programs.185 less than half (49%) mentioned public health functionality and goals.186 remarkably, 62% of the pdmp in this study did not so much mention overdose prevention in their public-facing materials.187 in terms of their legal and institutional structure, the national pdmp landscape is heterogeneous along a number of parameters. many pdmps (20, 39%) now reside in departments of health, though a significant minority (6, 12%) continue to be operated by law enforcement or justice agencies.188 since none of the programs reside within healthcare institutions, they are not covered 181. what states need to know about pdmps, supra note 11. 182. traci c. green et al., discrepancies in addressing overdose prevention through prescription monitoring programs, 153 drug & alcohol dependence 355, 356-57 (2015) (illustrating the thematic orientation of the program language (see figure 1)). 183. id. 184. id. 185. id. at 356 186. id. 187. id. 188. see figure 1. cf. nat’l all. for model state drug laws, prescription drug monitoring program (pmp) administering agency (june 30, 2017), http://www.namsdl.org/ library/4421dc96-d2c0-7410-fa15c9c4e6c3bf56/ [https://perma.cc/bp7v-nsqc] (noting discrepancies in data, with namsdl reporting only (3, 6%) programs are housed in law enforcement agencies and (36, 70%) reside in dph or board of pharmacies). 166 indiana health law review [vol. 15:139 by hipaa and other federal and state provisions that protect personal health information.189 programs vary in the scope of controlled substances coverage. most (36, 70%) track all five schedules.190 although it is not a controlled substance under the federal schedule, proposals have been made to integrate naloxone--the opioid antidote--among tracked medications.191 other drugs increasingly implicated in polysubstance use with opioids are being advanced as candidate for pdmp tracking.192 it is important to underscore that this record-keeping constitutes much more than just highly-dangerous narcotic or amphetamine drugs. schedules within the federal and state csas are expansive, which means that pdmps engage in sweeping data collection sometimes seemingly disconnected from their stated purpose. for instance, this surveillance includes prescription hormonal therapy used in gender transition therapy (classified under schedule iii).193 to improve system utilization, states have also adopted a number of mandates that prescribe the situations when providers must register for and access the pdmp.194 for instance, massachusetts mandates all newly-licensed prescribers to be registered in the system, and has instituted an effort to register existing 189. nat’l all. for model state drug laws, prescription drug monitoring programs (pmps) and the health insurance portability and accountability act (hippa): brief overview (2017), http://www.namsdl.org/library/ed56718e-a683-22aafdee3cd77be925de/ [https://perma.cc/h4r2-ldyf]. the privacy rule of hippa (45 c.f.r. §164.502) only protects the confidentiality of health information when used and disclosed by a statute-defined “covered entity” or “business associate”. under hippa, a covered entity is defined as a “health plan, a health care clearinghouse, or a health care provider”. a business associate is defined as a person “providing certain services to or for a covered entity” or “creating, receiving, maintaining, or transmitting [public health information], on behalf of a covered entity”. because pdmps fail to align with either definition, they are not subject to the privacy rule or other standards of hippa. 190. nat’l all. for model state drug laws, substances monitored by pmp (may 2016), http://www.namsdl.org/library/8d7261f8-e47d-b6a5-dd0cafa98fea4846/ [https://perma.cc/n327-tcpa]. 191. naloxone data, prevent overdose ri (2017), http://preventoverdoseri.org/naloxonedata/ [https://perma.cc/x4se-kkyb] (showing that rhode island is already tracking naloxone prescriptions). 192. ky. rev. stat. ann. § 218a.202 (2017). 193. androgel® (testosterone gel) 1%, unimed pharmaceuticals, inc. (2004), h t tps:/ /www.accessdata.fda.gov/dru gsa t fda_ docs / label/2004/21015s012lbl.pdf [https://perma.cc/4php-8snx]. 194. sixteen states require prescribers to access the pdmp. while all these states require a pdmp check before prescribing to a new patient, other mandates are also in place, varying by state: every time a prescription is started for longer than seven days, every six months that a patient is on a continuous opioid prescription, anytime a provider prescribes a schedule ii or iii drug, or anytime a provider prescribes an opioid or benzodiazepine. pdmp reporting and authorized use map, law atlas: the policy surveillance portal (2016) http://legacy.lawatlas.org/query?dataset= prescription-monitoring-program-laws-1408223416 [https://perma.cc/j29f-nkk6]. 2018] deploying prescription drug monitoring 167 providers as part of their continuing medical education.195 it also requires health care providers to consult its masspat system each time they prescribe any schedule ii substance.196 every new patient presenting to a massachusetts prescriber triggers a mandatory pdmp assessment.197 nationally, an increasing number of states are adopting similar provisions.198 states legislatures have recognized patient privacy concerns by erecting a variety of protections to safeguard highly-personal data collected by precritpion surveillance systems. these pdmp privacy protections vary widely, but often include a definition of the circumstances and authorization required for each querying party. for instance, a substantial number (15, 29%) require in-state law enforcement to present a warrant, (25, 49%) require a certification of an active investigation, and (45, 88%) require a subpoena to access pdmp data.199 for outof-state law enforcement, a substantial number (13, 25%) require a warrant or a judicially-approved show of probable cause.200 conversely, the overwhelming majority of programs (39, 76%) either compel or permit pdmps to transmit data on suspicious activity to law enforcement.201 this context has a number of implications for the public health value and potential unintended impact of pdmps. first, though heterogeneous in their precise design and legal posture, the majority of pdmps currently allow warrantless law enforcement access.202 in states where access is contingent upon the presence of an “active investigation” or “probable cause,” pdmps systems may run searches and deploy “predictive” algorithms that trigger investigations, functionally circumventing these access requirements.203 broad law enforcement access to some of the most private health information creates a number of problems, including blurring the line between healthcare and law enforcement.204 it risks further stigmatization, deterring patients from 195. 105 mass. code regs. 700.004(a)(1) (2017). 196. 105 mass. code regs. 700.012(g) (2017). 197. id. 198. nat’l all. for model state drug laws, mandated use of prescription drug monitoring programs (pmps) – map (june 30, 2017), http://www.namsdl.org/library/fe179822e782-aa56-9e97d5e5d9f19d7b/ [https://perma.cc/k6hb-6q9q] (noting that as of 2017, thirtysix states have adopted legislation which under specific circumstances requires prescribers to access the pmp). 199. see figure 1. 200. id. 201. id. 202. nat’l all. for model state drug laws, types of authorized recipients–law enforcement officials (dec. 2014), http://www.namsdl.org/library/bcea5cfb-e29a-b5613b62960ef453d9b3/ [https://perma.cc/nn92-797u]. 203. id. 204. see, e.g., joannah shepherd, combating the prescription painkiller epidemic: a national prescription drug reporting program, 40 am. j. l. & med. 85 (2014) (calling for a federal pdmp to replace state systems, no mention of possible unintended consequence is made); see also richard c. ausness, the role of litigation in the fight against prescription drug abuse, 116 w. va. l. 168 indiana health law review [vol. 15:139 accessing appropriate medications or seeking help for problematic substance use. this disproportionately impacts those groups with a history of discrimination and exclusion in healthcare settings, including people who inject drugs, racial minorities, trans and sexual minority patients.205 these concerns are not unique to the deployment of pdmps. even elsewhere in the health care arena, observers have critiqued the advent of algorithms, artificial intelligence analytical tools and other “big data” techniques whose cavalier adoption did not adequately consider the data quality, practical, or ethical implications of these systems.206 more in line with the law enforcement roots of pdmps however are the growing concerns about “predictive policing,” “gang database” and other algorithmic systems increasingly used by security agencies.207 these critiques have focused on assumptions of questionable empirical, ethical, or legal value that, when codified into algorithms, perpetuate injustice and misapplication of resources.208 rev. 1117, 1164 (2014) (asserting that pdmps are a key response in the overdose crisis; once again, no mention of possible unintended consequence is made). 205. fairchild, et al., supra note 49. see also or. prescription drug monitoring program v. u.s. drug enf’t admin., 860 f.3d 1228 (9th cir. 2017). 206. bonnie kaplan, how should health data be used? privacy, secondary use, and big data sales, 25 cambridge q. healthcare ethics 312 (2016) (presenting an ethical analysis on the commodification of health data, and the questions of privacy versus public interest and considering the impact of two court decisions involving the sale of prescription drug data, sorrell v. u.s. and source v. u.k., and their influence on both public trust and future policy). see also aris gkoulalas-divanis et al., publishing data from electronic health records while preserving privacy: a survey of algorithms, 50 j. biomed. informatics 4 (2014) (reviewing forty-five algorithms for protecting patient privacy when publishing electronic health record data and establishing the importance of designing data sharing around patient privacy protections). 207. walter l. perry et al., predictive policing: the role of crime forecasting in law enforcement operations (rand corp. 2013) (investigating law enforcements’ increasing utilization of quantitative analytical techniques to predict crime, determine future offenders and anticipate locations for police intervention); uzodima f. aba-onu, evaluation of gang databases in minnesota and recommendations for change, 19 info. & comm. tech. l. 223 (2010) (establishing the impact of minnesota’s gang database on communities of color, and highlights its failure to protect privacy or eliminate racial bias within its design). 208. kristian lum & william isaac, to predict and serve?, 13 significance 14 (2016) (demonstrating that current models of predictive policing can reinforce racial bias and lead to disparate policing practices on communities already confronted with over-policing); andrew guthrie ferguson, the rise of big data policing: surveillance, race, and the future of law enforcement (nyu press 2017) (examining what ferguson defines as the “black data” of big data policing: data buried within complicated algorithms, disproportionately affecting people of color, passed along as trendy and “futuristic,” and resting in the legal shadows, and claiming that big data is revolutionizing policing, with serious implications for already vulnerable populations); christian sandvig et al., auditing algorithms: research methods for detecting discrimination on internet platforms, data and discrimination: converting critical concerns into productive inquiry (2014) (highlighting the need for both increased public 2018] deploying prescription drug monitoring 169 an emerging trend in pdmp design and authority underscores more overt stigmatizing potential of these systems. it involves pdmp provision of criminal justice information, specifically drug conviction or charge data, to prescribers and dispensers. the state of wisconsin requires law enforcement agencies to report drug-related violations, opioid overdoses or deaths, and prescription drug diversion incidents to the pdmp, integrating those data with the patient’s prescription information. similarly, kentucky requires the administrative office of the courts (aoc) to communicate drug conviction data to its pdmp.209 the stand-alone diversion alert program in maine provides data on drug-related criminal charges to health care providers.210 now that we understand the landscape, what is the evidence on the impact of these programs? the next section addresses this. iv. pdmps impact on the overdose crisis a. review of the available evidence what is known about the impact of pdmps on the overdose crisis? when it comes to tracking diversion of medications, curbing their misuse, and reducing “doctor shopping,” the evidence on pdmps has been characterized as “mixed and inconclusive.”211 more fundamentally, however, determining “success” of pdmps is predicated first and foremost on how success is defined and measured. when pdmps are assessed, the outcomes of interest tend to closely reflect the “epidemic” framing of the overdose crisis as a vector-driven problem, with “overprescription” at its root and supply reduction its most promising remedy. this framing helps explain why most of the research published this decade focuses narrowly on the relationship between pdmp policies or programs and indicators closely aligned with opioid supply (see table 1). when assessing the thirty-four peer-reviewed empirical studies of pdmp impact from 2010 onwards, most (71%, twenty-one of thirty-four studies; see table 1) focused on outcomes such as the frequency, volume and durations of prescriptions.2 1 2 interest scrutiny and systematic analyses of algorithms. sandvig adapts the social scientific audit study to offer potential research methodologies for an “algorithm audit”, intended to provide researchers with the tools to identify, analyze and hold accountable discriminatory and problematic algorithms). 209. ky. rev. stat. ann. § 218a.202. 210. diversion alert: a spotlight on prescription drug abuse, http://www.diversionalert.org [https://perma.cc/3zwp-8ztb]. 211. see dep’t of health & human servs., office of the surgeon general, supra note 158; tamara m. haegerich et al., what we know, and don't know, about the impact of state policy and systems-level interventions on prescription drug overdose, 145 drug & alcohol dependence 34 (2014). 212. david baehren et al., a statewide prescription monitoring program affects emergency department prescribing behaviors, 56 annals of emergency med. 19 (2010) (showing decrease 170 indiana health law review [vol. 15:139 in prescribing among physicians after access to pdmp data); leonard j. paulozzi et al., prescription drug monitoring programs and death rates from drug overdose, 12 pain med. 747 (2011) (showing increase in prescribing of schedule iii opioids after pdmp and no impact on schedule ii prescribing and overdose deaths); joanne e. brady et al., prescription drug monitoring and dispensing of prescription opioids, 129 pub. health reps. 139 (2014) (finding that implementation of pdmps did not show a significant impact on per-capita opioids dispensed); hal johnson et al., decline in drug overdose deaths after state policy changes — florida, 2010–2012, 63 morbidity & mortality weekly report 569 (july 4, 2014) (noting a cdc report finding state policies in florida, including pdmp implementation, were associated with a reduction in fatal overdoses); patricia r. freeman et al., inst. for pharmaceutical outcomes & pol., kentucky house bill 1 impact evaluation (2015) (explaining that impact evaluation for state of kentucky found a relationship between mandating the pdmp system and reducing doctor shopping in the state, and displaying relationship between pdmp mandate and increased heroin overdoses); lainie rutkow et al., most primary care physicians are aware of prescription drug monitoring programs, but many find the data difficult to access, 34 health aff. 484 (2015); yuhua bao et al., prescription drug monitoring programs are associated with sustained reductions in opioid prescribing by physicians, 35 health aff. 1045 (2016) (finding implementation of pdmp had limited effect on opioid prescribing); linda simoni wastila & jingjing qian, influence of prescription monitoring programs on analgesic utilization by an insured retiree population, 21 pharmacoepidemiology & drug safety 1261 (2012) (according to this study, pdmps were associated with reduction in schedule ii prescription opioids and increases in lower scheduled analgesics); sarah e. wixson et al., impact of south carolina's prescription drug monitoring program on the use of benzodiazepines in a commercially insured population, 16 value in health a248 (2013) (finding a relationship between pdmp implementation in south carolina and an increase in the prescribing of benzodiazepines); hsienchang lin et al., associations between statewide prescription drug monitoring program (pdmp) requirement and physician patterns of prescribing opioid analgesics for patients with non-cancer chronic pain, 76 addictive behaviors 348 (2018) (finding no significant relationship between the implementation of prescription monitoring systems and rates of opioid prescribing for chronic pain management); brian suffoletto et al., the impact of a statewide mandatory prescription drug monitoring program on opioid prescribing by emergency medicine providers across 15 hospitals in a single health system, am. pain society (2017) (in press with the journal of pain) (finding that a state-mandated pdmp reduced prescribing of opioids among emergency medicine providers in pa); hsien-yen chang et al., impact of prescription drug monitoring systems and pill mill laws on high-risk opioid prescribers: a comparative interrupted time-series analysis, 165 drug & alcohol dependence 1 (2016) (finding a significant reduction in opioid prescribing by “highrisk” prescribers in florida); eric wright, the early impact of the indiana scheduled prescription electronic collection and tracking (“inspect”) program: a potentially effective policy tool for reducing prescription drug abuse, 14 indiana health l. rev. 112 (2017) (finding reduction in overall opioid prescribing within the state after indiana’s implementation of a prescription monitoring system); matthew mcallister et al., impact of prescription drug-monitoring program on controlled substance prescribing in the ed, 33 am. j. emergency med. 781 (2015) (finding that although a majority of prescribers perceived their prescribing practices had changed in response to prescription monitoring, there was no change in the average number of prescribed controlled substances when presented with pdmp data); patience moyo et al., impact of 2018] deploying prescription drug monitoring 171 prescription drug monitoring programs (pdmps) on opioid utilization among medicare beneficiaries in 10 us states, 112 addiction 1784 (2017) (finding the use of pdmps resulted in a reduction of prescription duration); courtney r. yarbrough, prescription drug monitoring programs produce a limited impact on painkiller prescribing in medicare part d, health servs. res. (2017) (finding pdmps were not associated with changes for prescription of nonopioid analgesics or other opioids in schedules ii and iii and a modest effect on oxycodone); linda rasubala et al., impact of a mandatory prescription drug monitoring program on prescription of opioid analgesics by dentists, 10 plosone (2015) (finding significant reduction in the number of opioid prescriptions after implementation of the mandatory pdmp); richard brown et al., impact of new york prescription drug monitoring program, i-stop, on statewide overdose morbidity, 178 drug & alcohol dependence 348 (2017) (finding an insignificant leveling off prescription overdose mortality levels after pdmp but increase in heroin overdose); deborah dowell et al., mandatory provider review and pain clinic laws reduce the amounts of opioids prescribed and overdose death rates, 35 health aff. 1876 (2016) (finding pdmp implementation associated with reduction in both prescription and illicit opioid overdose deaths); ellen meara et al., state legal restrictions and prescription-opioid use among disabled adults, 375 new eng. j. med. 44 (2016) (finding controlled-substance laws, including pdmp implementation, was not associated with reductions in potentially hazardous use of opioids or overdose); hefei wen et al., states with prescription drug monitoring mandates saw a reduction in opioids prescribed to medicaid enrollees, 36 health aff. 733 (2017) (finding pdmp utilization mandates were associated with a reduction in schedule ii opioid prescriptions); dhaval m. dave et al., mandatory access prescription drug monitoring programs and prescription drug abuse (nat’l bureau of econ. research, working paper no. 23537, 2017) (finding mandatory pdmp access was significantly associated with a reduction in prescription drug abuse); liza m. reifler et al., do prescription monitoring programs impact state trends in opioid abuse/misuse?, 13 pain med. 434 (2012) (finding reduction in opioid-related treatment admissions following pdmp implementation); marcus bachhuber et al., prescription monitoring programs and emergency department visits involving benzodiazepine misuse: early evidence from 11 united states metropolitan areas, 28 intern. j. drug pol. 120 (2016) (finding pdmp implementation did not affect rates of emergency department visits related to the misuse of benzodiazepines); brandon maughan et al., prescription monitoring programs and emergency department visits involving opioids, 2004-2011, 156 drug & alcohol dependence 282 (2015) (finding no significant effect on the misuse of prescription drugs); hilary l. surratt et al., reductions in prescription opioid diversion following recent legislative interventions in florida, 23 pharmacoepidemiology & drug safety 314 (2014) (finding significant declines in diversion rates for opioids in florida after pdmp implementation); cj hayes, impact of state mandated queries of the prescription drug monitoring programs on opioid and non-opioid drug related adverse effects: a difference in difference approach, 19 health in value a347 (2016) (finding no association between adverse events related to prescription use and pdmp mandates); douglas keith branham et al., time-series analysis of the impact of prescription drug monitoring programs on heroin treatment admissions, substance use & misuse 1 (2017) (finding an increase in heroin treatment admissions after pdmp implementation); bryce pardo, do more roust prescription drug monitoring systems reduce prescription opioid overdose?, 112 addiction 1773 (2017) (finding increase in pmp strength associated with decrease in prescription overdose deaths); guohua li et al., prescription drug monitoring and drug overdose mortality, 1 injury epidemiology 9 (2014) (finding that 172 indiana health law review [vol. 15:139 given the central role of drug control and other law enforcement in the design, utilization, and continued principal resourcing213 of pdmps, evaluators have also focused closely on how pdmp deployment may impact instances of (notably arbitrarily-defined) “aberrant behavior,” including “doctor shopping”214 (12%, four of thirty-four studies), diversion, and drug misuse215 (32%, eleven of thirtyfour studies). even using these supply-oriented metrics, pdmp evaluations have continued to bear mixed results. in a ten-state study, moyo216 observed an overall decrease in the monthly opioid volume being dispensed across pdmp states. however, the presence of monitoring programs was not associated with changes in number of prescriptions or the mean morphine milligram equivalent per prescription.217 similarly, a recent analysis of a new policy in massachusetts aimed at reducing opioid prescribing (in a state that ranked seventh in the nation for opioid overdose deaths in 2015), found no evidence of impact.218 the policy entailed the state’s department of public health emailing all prescribers information on the number of opioid prescriptions they and their peers wrote, along with the total volume of opioids they had prescribed in the previous year. not only was there no evidence of fewer prescriptions, but there was also no reduction in opioid prescribing implementation of pdmps did not reduce drug overdose mortality rates in most states); chris delcher et al., abrupt decline in oxycodone-caused mortality after implementation of florida’s prescription drug monitoring system, 150 drug & alcohol dependence 68 (2015) (finding a significant relationship between pdmp implementation and a decrease in oxycodone-caused mortality in florida).; stephen w patrick et al., implementation of prescription drug monitoring programs associated with reductions in opioid-related death rates, 35 health aff. 1324, 1324-32 (2016), https://www.ncbi.nlm.nih.gov/pubmed/27335101 [https://perma.cc/u474-bqw5]. 213. principal funding of pdmps comes through grants to the states from the hal rogers program at the bureau of justice assistance, u.s. department of justice. technical assistance guide no. 04-13: funding options for prescription drug monitoring programs, prescription drug monitoring program training and technical assistance center (2013). 214. see freeman et al., supra note 212; meara et al., supra note 212; ali et al., supra note 212; see buchmueller et al., supra note 212; carey colleen, the effect of prescription drug monitoring programs on opioid utilization in medicare (nat’l bureau of econ. research, working paper no. w23148, 2017) (finding mandatory use of pmdps was associated with fewer patients receiving prescriptions from multiple doctors). 215. see johnson et al., supra note 212; brown et al., supra note 212; meara et al., supra note 212; ali supra note 212; dave et al., supra note 212; reifler et al., supra note 212; bachhuber et al., supra note 212; maughan et al., supra note 212; surratt et al., supra note 212; hayes, supra note 212; branham et al., supra note 212. 216. see moyo et al., supra note 212. 217. id. (finding strong variability across states and subcategories of medicare beneficiaries). 218. michael l. barnett et al., coupling policymaking with evaluation—the case of the opioid crisis, 377 new eng. j. med. 2306, 2306-09 (2017) (examining the effect of a recent policy aimed at reducing opioid prescribing in massachusetts found no evidence that prescribing rates dropped). 2018] deploying prescription drug monitoring 173 among the highest-volume opioid prescribers.219 substantially fewer evaluations have focused in the public health realm, with (6%, two of thirty-four studies) opioid-related treatment admissions220 and opioid overdose mortality221 (32%, eleven of thirty-four studies). in addressing the current crisis, measuring pdmp success primarily through study endpoints like reductions in prescribing volume222 and suppression of multiple-prescriber episodes (“doctor shopping” in colloquial parlance) is problematic. such narrow definitions of effectiveness mask the complexities of addressing overdose and addiction on the systems level.223 it is not clear to what extent outcomes such as prescribing volume224 can serve as an appropriate “surrogate” endpoint for research in the realm of pdmp public health impact.225 ongoing debate about the appropriate use of surrogate endpoints in clinical trials226 helps to inform this debate. just like it may be inappropriate to use an intermediate biological marker as evidence that a drug may improve cancer survivorship,227 it may not in fact be appropriate to use declines in opioid prescribing rates as a metric of progress in the effort to address population-level overdose morbidity and mortality. this is especially true because nationally, as well as on a more granular jurisdictional level, reductions in prescribing have not systematically resulted in statistically significant drops in overdose rates.228 for example, after the implementation of west virginia’s pdmp, a significant drop 219. id. 220. see reifler et al., supra note 212; branham et al., supra note 212. 221. see johnson, supra note 212; paulozzi, supra note 212; hayes, supra note 212; brown et al., supra note 212; dowell et al., supra note 212; freeman, supra note 212; meara et al., supra note 212; pardo, supra note 212; li et al., supra note 212; delcher et al., supra note 212. 222. see wen et al., supra note 212; brady et al., supra note 212. 223. robert g. newman, the epidemiological approach to drug abuse: its relevance to the teaching of future professionals, 3 am. j. drug & alcohol abuse 439, 439-46 (1976) (making the case that dogma and simplistic solutions toward substance use have historically led to inadequate public health policy). 224. see rasubala et al., supra note 212. 225. janet weiner et al., prescription drug monitoring programs evolution and evidence, leonard davis inst. of health econ. issue brief 6 (2017) (finding that pdmps were not associated with reductions in drug overdose mortality rates, and may be related to increased mortality from illicit drugs). 226. david a. grimes & kenneth f. schulz, surrogate end points in clinical research: hazardous to your health, 105 obstetrics & gynecology 1114 (2005); aaron s. kesselheim et al., the high cost of prescription drugs in the united states: origins and prospects for reform, 316 jama 858 (2016). 227. id. 228. see li et al., supra note 212; meara et al., supra note 212; young hee nam et al., state prescription drug monitoring programs and fatal drug overdoses, 23 am. j. managed care 297 (2017) (finding the pdmps were not associated with reductions in drug overdose mortality rates, and may be related to increased mortality from illicit drugs). 174 indiana health law review [vol. 15:139 in opioids dispensed was found from 2008 to 2015.229 during that same time window, the study also documented a 200% spike in unintentional poisonings involving heroin.230 if the ultimate goal is to curb overdose, then pdmps’ utility is far from clear.231 our review found that only 32% (eleven of thirty-four)232 of the relevant empirical studies even included overdose morbidity or mortality as a metric of pdmp impact, despite this outcome clearly being the policy goal of primary—if not sole—importance. of those studies that assessed pdmp impact in this vital arena, all eleven considered prescription drug related overdoses as a metric of interest. among these studies, six found pdmp deployment to be associated with lower prescription drug overdose rates,233 and five reported a null result.234 more recent research continues to bear characteristically mixed results. in an analysis of programs nationwide, patrick et al.235 found an average reduction of 1.12 prescription opioid-related overdose deaths per 100,000 population in the year after a state’s implementation of a prescription monitoring program. but this analysis did not control for key confounders, like state medical marijuana policies.236 pardo, for example,237 found that states with more intensive pdmp programs saw a reduction in prescription drug overdoses; however, when controlling for covariates, they found that states with medical marijuana dispensaries reported a 16% reduction in in prescription drug overdose deaths. ultimately, pdmp evaluation research should not be limited to measuring only overdose morbidity and mortality linked only to prescription drugs. given 229. sarah warfield et al., address at american public health association annual meeting & expo: heroin and prescription opioid poisonings in west virginia, 2008-2015–the potential impact of legislative interventions (2017) (evaluating changes in opioid poisoning hospitalization rates after implementation of west virginia’s prescription drug monitoring program). 230. id. 231. see paulozzi et al., supra note 212 (noting that in 2011, the cdc reviewed the evidence on links between pdmps and overdose, finding no evidence of impact). 232. see johnson et al., supra note 212; freeman et al., supra note 212; delcher et al., supra note 212; dowell et al., supra note 212; patrick et al., supra note 212; pardo, supra note 212; paulozzi et al, supra note 212; li et al., supra note 212; brown et al., supra note 212; hayes et al., supra note 212; meara et al., supra note 212. 233. see johnson et al., supra note 212; freeman et al., supra note 212; delcher et al., supra note 212; dowell et al., supra note 212; patrick et al., supra note 212; pardo, supra note 212. 234. see paulozzi et al., supra note 212; li et al., supra note 212; brown et al., supra note 212; hayes et al., supra note 212; meara et al., supra note 212. 235. see patrick et al., supra note 212. 236. there have been a number of studies identifying an independent relationship between marijuana regulation and opioid overdose rates. for instance, a time-series analysis of medical cannabis laws and state-level cause of death data revealed a 24.8% lower mean annual opioid overdose mortality compared to states which prohibit medical cannabis. see bachhuber et al., supra note 212; see also elyse phillips & julie gazmararian, implications of prescription drug monitoring and medical cannabis legislation on opioid overdose mortality, 13 j. opioid mgmt. (2017). 237. see pardo, supra note 212. 2018] deploying prescription drug monitoring 175 widespread misclassification of opioid overdose deaths,238 as well as the fungibility of the opioid use and documented transition from prescription to black market drugs, the most appropriate metric of success would be to consider pdmp impact on all opioid-involved overdoses, including prescription and nonprescription sources. in this review, only one in five published peer-reviewed studies (21%; see table 1) included an overdose morbidity or mortality-related research endpoint that was not specific to prescription drugs.239 of those, three found pdmp deployment to be associated with lower overall overdose rates,240 while four reported a null result.241 notably, three studies reported pdmp program or policy elements to be associated with a rise in non-prescription overdose rates.242 these decidedly equivocal findings stand to challenge the kind of unbridled enthusiasm, generous investment, and cavalier policy emphasis that has buoyed pmdps since the onset of the overdose crisis. insofar as the pdmp tracks reductions in doctor shopping or other drug user behavior deemed “problematic,” those observations may reflect health care providers’ and drug users’ defensive practices, rather than real improvements. providers may rebuke, abandon, and “fire” patients with suspicious or in some way aberrant histories or behaviors, as a defensive tactic to reduce their exposure to potential professional and criminal liability.243 an evolving trend in highprofile cases where prescribers are being held criminally responsible for the overdose deaths of their patients244 underscores the real and perceived risk of 238. see rudd et al. supra note 127 (noting that “heroin and morphine are metabolized similarly, [opioid overdose deaths may be] misclassified,” and citing gregory g. davis & national association of medical examiners and american college of medical toxicology expert panel on evaluating and reporting opioid deaths, national association of medical examiners position paper: recommendations for the investigation, diagnosis, and certification of deaths related to opioid drugs, 10 j. med. toxicology 100 (2014)). 239. see paulozzi et al., supra note 212; li et al., supra note 212; brown et al., supra note 212; hayes et al. supra note 212; johnson et al., supra note 212; freeman et al., supra note 212; patrick et al., supra note 212. 240. see paulozzi et al., supra note 212; li et al., supra note 212; brown et al. supra note 212; hayes et al., supra note 212. 241. see johnson et al., supra note 212; freeman et al., supra note 212; patrick et al., supra note 212. 242. see brown et al., supra note 212; freeman et al., supra note 212; johnson et al., supra note 212. 243. m. demidenko et al., suicidal ideation and suicidal self-directed violence following clinician-initiated prescription opioid discontinuation among long-term opioid users, 47 gen. hosp. psychiatry 29 (2017) at 29-32 (noting the tragic consequences of opioid tapering and patient abandonment in response to policies and programs that emphasize dose reduction). 244. see michael nedelmen, doctors increasingly face charges for patient overdose, cnn (july 31, 2017, 5:19 am), http://www.cnn.com/2017/07/31/health/opioid-doctors-responsibleoverdose [https://perma.cc/7p48-gapp] (outlining a trend in doctors being charged with the death of their patients); marisa gerber et al., california doctor convicted of murder in overdose deaths of patients, l.a. times (oct. 30, 2015, 3:46 pm), http://www.latimes.com/local/lanow/la-me-ln176 indiana health law review [vol. 15:139 criminal, civil, and professional censure. defensive practices spurred by these regulatory forces are chilling opioid prescribing even when medically necessary.245 patients may also respond to both pdmp and provider-initiated signals by shifting their behavior to avoid detection. in that context, a patient with a severe substance use disorder who had previously engaged in doctor shopping (and therefore be at a high risk of future overdose)246 may respond to perceived or real monitoring by moving their activity outside of the surveillance realm. without concerted efforts to retain that patient in care, such a move would entail being relegated to the black market. the result: the pdmp may reflect fewer “drug seeking” incidents or multiple prescriber episodes, but at a cost of increased risk to the individual and to the public’s health. methodological challenges will continue to muddy the picture on pdmp impact.247 given the number of different policy and programmatic elements of pdmps, as well as the historical reality that these elements have often changed contemporaneously with implementation of other policy and programmatic interventions, it may not be ultimately possible to isolate their impact. in the words of the surgeon general’s seminal report on the opioid crisis: “multiple efforts to address prescription drug misuse within states occurring in concert with mandatory pdmp legislation may limit the ability to draw causal conclusions about the effectiveness of mandatory use of pdmps.”248 what is behind the mismatch between the confidence and resources invested in pdmps and their real-world impact? the problem is not, as some have argued, just that many healthcare providers are reluctant249 to use these (sometimes clunky) databases, that states fail to share data250 or that mandates requiring their doctor-prescription-drugs-murder-overdose-verdict-20151030-story.html [https://perma.cc/26949mnr] (describing story of high-profile doctor charged with the death of his patient who overdosed); robert siegel, doj stepping up prosecutions of medical providers who abuse prescribing authority, npr (dec. 11, 2017, 4:38 pm), https://www.npr.org/2017/12/11/ 569983638/doj-stepping-up-prosecutions-of-medical-providers-who-abuse-prescribing-authority [https://perma.cc/et5c-xltc] (describing how the department of justice is ramping up prosecutions of providers who overprescribe opioids). 245. stefan g. kertesz, turning the tide or riptide? the changing opioid epidemic, 38 substance abuse 3 (2017). 246. meghan fibbi et al., denial of prescription opioids among young adults with histories of opioid misuse, 13 pain med. 1040, 1040-48 (2012). 247. see corey s. davis, commentary on pardo (2017) and moyo et al. (2017): much still unknown about prescription drug monitoring programs, 112 addiction 1797, 1797-98 (2017). 248. dep’t of health & human servs., office of the surgeon general, supra note 158, at 3-26. 249. see rutkow et al., supra note 212. 250. dep’t of health & human servs., prescription drug monitoring programs interoperability standards: report to committee on health, education, labor, and pensions and committee on energy and commerce, 112th cong. (2013). 2018] deploying prescription drug monitoring 177 use are insufficiently strict.251 the problem isn’t even that over-reliance on pdmps may, at times, paradoxically increase prescription252 of painkillers. the key issue is that pdmps are designed only to generate information. what ultimately matters is how that information is used, and by whom. without adequate context and transparency between patients and providers about their own information stored on pdmps, patients stabilized on high doses of opioids are increasingly concerned about the future their pain management care.253 currently, such patients have no right to review their own pdmp data, thus having no recourse to challenge or correct discrepancies in their prescription history that may be misconstrued as substance misuse or “drug-seeking behavior.”254 this imbalance of power is especially concerning in the context of law enforcement accessing sensitive medical records: what criteria are based to distinguish between substance misuse emblematic of addiction, bona fide pain care, and venal diversion? the lack of agency for patients to review—and correct—their own records may sew distrust among the patient community. withholding prescriptions and abandoning or “firing” complex or suspicious patients appear to be actions that may result from finding of unexpected information in pdmps. these actions may push patients away from the health care system, precipitating stigmatization and multiple cascading health harms. if “problem” patients are rebuked and turned away, they will likely seek out blackmarket alternatives—typically heroin, and increasingly, illicit fentanyl. even when practitioners do refer patients to treatment, many of the affordable, evidence-based programs have waitlists that are weeks—or months—long,255 leaving patients with few options in the meantime. in other words, without health 251. rebecca l. haffajee et al., mandatory use of prescription drug monitoring programs, 313 jama 891, 891-92 (2015). 252. scott g. weiner et al., clinician impression versus prescription drug monitoring program criteria in the assessment of drug-seeking behavior in the emergency department, 62 annals emergency med. 281, 284-89 (2013) (describing an assessment of emergency room physicians prescribing behaviors before and after accessing pdmp data reflected a small increase in their likelihood to prescribe opioid medication at discharge, and noting access to this pdmp data may have given providers greater confidence in prescribing to patients previously assumed to be at risk for prescription drug misuse). 253. see dan verango, he took opioids to manage his chronic pain. when his doctors took them away, he didn’t want to live anymore, buzzfeed (nov. 30, 2017, 10:47 am), https://www.buzzfeed.com/danvergano/chronic-pain-debate-opioid-painkillers?utm_ term=.tk6ezddry#.tx50p88n2 [https://perma.cc/tup9-kmzu] (discussing pain patients losing access to opioids); robert langreth, millions of patients face pain and withdrawal as opioid prescriptions plummet, bloomberg (nov. 21, 2017, 11:26 am), https://www.bloomberg.com/ news/articles/2017-11-21/millions-of-patients-face-pain-and-withdrawal-as-opioid-prescriptionsplummet [https://perma.cc/yc52-a84m] (discussing pain patients being abandoned due to prescribers abruptly ending pain management). 254. see generally weiner et al, supra note 252. 255. jason cherkis, dying to be free, huffpost (jan. 28, 2015), http://projects. huffingtonpost.com/dying-to-be-free-heroin-treatment#chapter-one [https://perma.cc/4ffy-yb6j]. 178 indiana health law review [vol. 15:139 care providers adequately understanding how to use information gleaned from pdmps to simultaneously reduce prescription drug misuse and keep patients engaged in care, the increased use of pdmps can cause more harm than good. public health surveillance can act as an intervention, changing behavior of those affected as well as other members of the community. in the case of pdmps, these programs engage in disseminating information and providing training to a variety of stakeholders, including law enforcement and health care providers. empirical analysis found little evidence that pdmps were using their online channels to educate its users and members of the public that were likely to reduce overdose or advance other public health goals. most programs provide didactic aides but do not provide substantive training.256 evaluation of the diversion alert program in maine underscores this point. this program provides health care practitioners with access to a database and alert system that contains criminal justice information about their patients. 257 its evaluation found that system access was associated with increased deployment of patient surveillance methods, including urine drug screens, random pill counts, and utilization of prescription drug monitoring program.258 the broader context for this empirical overview is that there is little evidence that interventions to reduce drug supply have any lasting positive impact on substance misuse or overdose.259 as has been the case with the vast majority of “supply-reduction” efforts mounted by the criminal justice system, the development of pdmps occurred largely without regard for empirical insights into how regulated entities may alter their behavior in response. the engineers of pdmp interventions did not appear to contemplate how patients would react to the real or perceived risk of breach of their confidential prescription information, or to being rebuked by a provider in response to information gleaned from the pdmp. much was assumed about how providers’ access and interpretation of prescription drug information can reduce inappropriate prescribing and diversion of drugs; doing so without unnecessarily restricting access to medication for bona fide patients received little consideration. b. original data original data collected as part of a larger project helps to contextualize these findings. we conducted twenty-three interviews with key stakeholders in massachusetts regarding their perspectives and experiences with the prescription 256. green et al., supra note 182. 257. sarah levin martin & clare derosiers, diversion alert: 1-year evaluation across northern new england, 2013-2014, preventing chronic disease, ctrs. for disease control & prevention (nov. 23, 2016), https://www.cdc.gov/pcd/issues/2016/16_0229.htm [https://perma.cc/9xne-aa53]. 258. id. 259. see leo beletsky & corey davis, today’s fentanyl crisis: prohibition’s iron law, revisited, 46 int’l j. of drug pol’y (2017). see also werb et al., supra note 175. 2018] deploying prescription drug monitoring 179 drug program.260 the full description of the study is beyond the scope of this paper, but several data points help to underscore a number of the shortcomings in pdmp design and implementation. two of the stakeholder groups interviewed during the project included healthcare providers and advocates for the substance user community. interviewees from both stakeholder groups expressed overlapping concerns regarding the pdmps effect on patient-physician relationships, the unintended harms of surveillance on prescribing practices and the failure of the pdmp design to provide support for patients with addiction. an advocate from a community organization for substance users suggested the pdmp does not play a major role in “curbing the epidemic” and may be responsible for increasing the use of illicit drug use: i really don’t see it playing much a role. i think it may have played an unintended role of more people accessing what substances they choose to use illegally. i think there are a lot of folks out there who are in legitimate pain and because they aren’t being treated properly for that pain, they have been accessing the medications and chemicals they need to make themselves feel better in an illicit and illegal way now, because of the pdmp. drug user group representative261 as this stakeholder suggested, the pdmps “supply-reduction” design offers little opportunity for patients and providers to reduce the “demand” for pain medication, potentially diverting patients towards illicit drug use through limitations on prescription medication. another dominant theme in these narratives was the role of pdmps as potentially furthering existing stigmatization of drug users in health care and pharmacy settings. a lot of people stay away from certain healthcare facilities or companies or whatever and because, they, of the way, the way they’ve begun targeting us and treating us in terms of, as using the pmp as a tool of oppression. drug user group representative262 this perspective highlights the potential of pdmps as a real or perceived barrier to help-seeking. such adverse impact could disproportionately impact individuals whose mistrust of government surveillance is based on personal or social group experiences warranting such caution. 260. leo beletsky, presentation at the 40th annual meeting of the college on problems of drug dependence: prescription drug monitoring: of law enforcement, or public health? montreal, canada (june 19, 2017). 261. id. 262. id. 180 indiana health law review [vol. 15:139 the dominant narrative from physicians was somewhat parallel to the community groups’ perspective, in the sense that prescribers critiqued the effect of the pmdp on patient-physician relationships and their ability as providers to effectively treat pain and addiction, the root causes of opioid “demand”, with one prescribing physician stating: i think physicians currently believe that their prescribing practices are now vulnerable to being monitored and unlike other aspects of their care and their treatment, how they prescribe to a given patient is there for everybody to see, however the reasons that they prescribed it, the carefulness with which they're monitoring, the effectiveness that it may have for the patient, that’s not there. prescribing physician263 c. concerns emerging from litigation another important source of information about the real-world impact of pdmps comes from emerging litigation, based specifically on privacy concerns. the recently-decided oregon prescription drug monitoring program and the aclu foundation of oregon v. united states drug enforcement administration264 case is especially illustrative of the privacy issues raised by the new or newly expanded pdmps, as they have emerged to combat the overdose crisis. at issue in this case is the oregon pdmp law, which requires law enforcement to obtain a warrant supported by probable cause to access prescription data. the dea routinely seeks data from state pdmps using only an administrative subpoena. oregon challenged this practice. joining the lawsuit were aclu of oregon and five individuals, including four patients and one prescribing physician. two of the john doe interveners were transgender men, whose hormone transition therapy was documented in the pdmp. in their declarations, these five individuals communicated their misgivings about the nearly unfettered availability of deeply-private pdmp data to federal agents, and the effect that is likely to have on their physical and mental health and prescribing behavior.265 they objected to the law on fourth amendment grounds. after prevailing below, the challenge to warrantless access advanced to the 9th circuit. on appeal, oregon lost. the court reasoned that the oregon law was in positive conflict with the federal csa, and was therefore preempted: it also reasoned that the intervenors lacked standing because “threatened injury must be certainly impending to constitute injury in fact, and . . . [a]llegations of possible 263. id. 264. or. prescription drug monitoring program v. u.s. drug enf’t admin., 860 f.3d 1228 (9th cir. 2016). 265. id. 2018] deploying prescription drug monitoring 181 future injury are not sufficient.”266 the state elected not to appeal the case further. the parallel case doj v. utah department of commerce reached a similar conclusion, though that opinion did reach—and rejected—the fourth amendment question on the expectation of privacy, based on third party doctrine.267 notably, the decision states “physicians and patients have no reasonable expectation of privacy in the highly-regulated prescription drug industry.”268 this decision was similarly not appealed. although these decisions technically constitute the law only in the 9th and 10th circuits, they are certain to have national impact. across the country, pdmp legislation includes a warrant requirement for law enforcement in 27 states.269 the broad subpoena power granted to the department of justice through the csa essentially means that federal law enforcement is able to obtain pdmp information without judicial review, extinguishing state-level protections as they apply to dea and other federal agents. moreover, there is nothing stopping federal agents from subsequently transferring data gleaned from warrantless pdmp searches to state or local law enforcement. this would certainly be in line with routine coordination and data sharing between federal, state, and local law enforcement in all aspects of drug law enforcement. this mechanism is in addition to the other “back door” which is the proactive pdmp reporting of “outlier” information authorized or mandated in thirty-nine states.270 v. harnessing pdmps to address the overdose crisis the preceding analysis carries key lessons for ways in which pdmp policies and programs can move towards evidence and away from ideology. as they now exist, and especially in view of the recent jurisprudence, the privacy issues may have a disproportionate impact on marginalized patients. it is not that the data are being collected, it is how these data are being used and who has access. in this, emerging concerns echo not just the past objections to public health surveillance but also current debates about dragnet government surveillance and “big data” techniques increasingly used for marketing and surveillance purposes.271 historical experience should prompt us to think critically about pdmps and proceed with caution. spurred by the opioid crisis, the evolution of pdmps has 266. id. at 1235 (quoting whitmore v. arkansas, 495 u.s. 149, 158 (1990)). 267. u.s. dep’t of justice v. utah dep’t of commerce, case no. 2:16-cv-611-dn-dbp, 2017 wl 3189868 (d. utah, july 27, 2017); see also smith v. maryland, 442 u.s. 735 (1979) (articulating the “third party doctrine” that challenges an individual’s reasonable expectation of privacy when dialing phone numbers, because those numbers are transmitted to the telephone company). 268. id. 269. see law atlas, supra note 194 and accompanying text. 270. id. see also justice system use of prescription drug monitoring programs, bureau of justice assist. 11-13 (2015), https://www.bja.gov/publications/globaljusticesystemusepdmps.pdf [https://perma.cc/wn3z-7w56]. 271. see bonnie kaplan, supra note 206. 182 indiana health law review [vol. 15:139 occurred without adequate attention to informed, user-driven design to maximize pdmps’ clinical and public health benefits, while minimizing their potential harms. as currently configured, there is little reason to believe that pdmps increase the use of proven overdose prevention measures; there is even some evidence they may drive patients away from engagement with the health care system.272 people with history of criminal justice involvement may be especially reticent to seek help if they perceive risk of law enforcement involvement. many of the same individuals may also face much higher risk of overdose.273 as the overdose crisis is driving the expansion of their operational and legal scope, these systems are being deployed with without adequate consideration of patient privacy and confidentiality. while their deterrence impact has not been adequately assessed, the potential for—and troubling signs of—unintended public health harms add urgency to a better calibration of the design and implementation of these programs. 274 there are clear opportunities for improvement, along several fronts. first and foremost, pdmps can and should be functionally reconfigured away from their current orientation on arbitrary metrics of “aberrant” practices to instead focus on health promotion as their express policy and evaluation guidepost. the conceptual, normative, and operational goal of pdmps must be to advance patient well-being. this implies the imperative to improve their ability to support sound clinical decision-making,275 including through common-sense choice architecture elements protective against opioid-benzodiazepine and other risky drug interactions within a patient’s pharmacotherapy regimen. algorithms can be deployed to assist providers in identifying patients who are especially vulnerable to overdose risk. instead of facilitating isolation and abandonment of at-risk individuals, these systems have the potential to facilitate engagement with improved physical and mental health care, including substance use treatment and other risk reduction modalities, such as naloxone access and syringe access services. simple design modifications can turn, pdmp into tools of patient care coordination, for example by integrating internal messaging platforms that could 272. richard m. reisman, prescription opioid usage and abuse relationships: an evaluation of state prescription drug monitoring program efficacy, 3 substance abuse 41 (2009). see also supra note 212. 273. leo beletsky, et al., fatal re-entry: legal and programmatic opportunities to curb opioid overdose among individuals newly released from incarceration, 7 ne. u. l.j. 155 (2015). 274. see, e.g. or. prescription drug monitoring program v. u.s. drug enf’t admin., 860 f.3d 1228, http://aclu-or.org/sites/default/files/pdmp_motion_to_intervene.pdf [https://perma.cc/ vzk2-xkqe] (challenging the administration of the oregon pdmp vis a vis the fourth amendment). 275. erin p. finley et al., implementing prescription drug monitoring and other clinical decision support for opioid risk mitigation in a military health care setting: a qualitative feasibility study, j. am. med. informatics ass’n (2017), http://academic.oup.com/jamia/advancearticle/doi/10.1093/jamia/ocx075/4086553 [https://perma.cc/9ura-cqa5] (discussing the opportunities of utilizing pdmps as a clinical decision support tool). 2018] deploying prescription drug monitoring 183 allow prescribers and pharmacists to communicate about a patient’s particular health needs. in terms of their public health surveillance function, pdmps can help understand the prevalence and incidence of use of certain drugs, track unexpected or adverse events, and target resources and interventions to patients and geographical areas most in need. as matters stand, pdmps exist largely outside of the health care information infrastructure and legal architecture. this means that, when looking up a patient on a typical pdmp database, a provider has no way of knowing anything about the patient beyond their basic demographic characteristics and prescription drug history within the particular state. this limits the utility of the data to inform provider, regulator, and public health researcher conclusions about appropriate regimens and dosage.276 inability to view pdmp data in context can lead to false positive and false negative conclusions about risky or problematic patterns and thus hampers efficacious policy or regulatory responses. therefore, pdmps should be integrated into other electronic medical records and treated in the same manner--from the perspective of clinical care. just like with any health information technology tool, providers need training to help them understand how and when they can fit these new sources of information into their practice.277 in similar vein, patients’ and potential patients’ knowledge and attitudes about pdmps are important considerations in efforts to encourage help-seeking and reduce stigmatization of drug use--whether licit or illicit. public health and law enforcement are beginning to work collaboratively to address the overdose crisis,278 including on the utilization of data. but there are very few examples of its uses to reduce patient risk at the point of care. the emerging reality that law enforcement in many jurisdictions can obtain largely unfettered access to pdmps through the legal back door mechanisms deserves further scrutiny. in this context, curtailment of federal regulations protecting drug treatmentrelated data being proposed in various forums279 would facilitate the integration of sud treatment data into pdmps, where the oregon and utah court decisions discussed above280 would expose highly-private information to warrantless drug enforcement administration searches. such access could discourage helpand healthcare-seeking, especially among the most vulnerable sud patients. instead, we should advocate that privacy protections be expanded to shield pdmp data from unfettered law enforcement access at state and federal levels. on the other hand, inclusion of an ever-broader set of information elements under the scope 276. joshua w. elder, garret depalma, and jesse pines, optimal implementation of prescription drug monitoring programs in the emergency department, 19 west. j. emer. med. 387, 387-391 (2018). 277. id. 278. see leo beletsky, law enforcement, drugs and the ‘public health’ approach, the crime report (apr. 19, 2016), https://thecrimereport.org/2016/04/19/law-enforcement-drugs-andthe-public-health-approach/ [https://perma.cc/7lvp-a34x]; see also justice system use of prescription drug monitoring programs, supra note 270. 279. see, e.g. kolodny and frieden, supra note 12, at 1537-38. 280. see supra notes 264-267 and accompanying text. 184 indiana health law review [vol. 15:139 of pdmps, such as the criminal justice data now being made available to providers in maine, kentucky and wisconsin, raise questions about further expansion of these systems into potentially stigmatizing domains of questionable clinical value. ultimately, deriving full value from effective public health surveillance without triggering unintended adverse consequences demands careful calibration. to accomplish this, legal and ethical canon draws on a familiar balancing test: to weigh the state imperative to protect the public’s health against the patients’ individual confidentiality and privacy rights.281 this framework, though rhetorically straightforward, is fundamentally flawed because more robust privacy protections catalyze effective surveillance and other essential public health functions. as illustrated above, surveillance efforts that fail to adequately safeguard patient data do much more than harm individual rights: by undermining patient trust and creating a system of perverse incentives, they can push patients away from seeking appropriate, timely help. at the population level, this hampers disease surveillance and control efforts, aggravating the very problems these policies and programs were intended to ameliorate.282 in other words, this policy heuristic fails to account for behavioral theory and empirical evidence on the impact of public health surveillance programs, sometimes backfiring a classic case of a “cobra effect.”283 this is an example of a situation where interests of individuals and populations are complimentary.284 american history is replete with episodes when confidentiality interests proved a weak counterweight to what in retrospect proved to be abusive or otherwise inappropriate public health surveillance efforts.285 this record is especially dismal when it comes to discriminatory and draconian monitoring of racial minorities or other groups deemed dangerous—the very same groups that face the most formidable hurdles in mounting legal or political challenges to such abuse.286 in place of this balancing test, i advocate for an approach that infuses formal legal norms and their implementation mechanisms with the precautionary 281. mariner, supra note 24, at 381. 282. id. at 375. 283. id. at 394. 284. see parmet supra note 21, at 273. 285. see mariner, supra note 24, at 388. 286. see id. (showing this balancing test is of further diminished utility in the many jurisdictions around the world where confidentiality rights hold less normative weight, and where substantive and procedural safeguards from undue government intrusion are poorly developed); stuart rennie et al., conducting unlinked anonymous hiv surveillance in developing countries: ethical, epidemiological, and public health concerns, plosmedicine (2009) (exploring the ethical implications of hiv surveillance programs in developing nations and the potential for vulnerable populations to be exploited or unjustly treated); anil kalhan, immigration surveillance, 74 md. l. rev. 1 (2014) (describing surveillance programs unique to the immigrant and refugee populations, and identifies national public health surveillance tools that have been used to track the health data of noncitizens). 2018] deploying prescription drug monitoring 185 principle to “do no harm.” to calibrate policy and programmatic elements of public health surveillance initiatives, policymakers should be expected to balance potential public benefits against foreseeable harms, be they rooted in the normative and ethical concerns about individual rights or patterns of perverse incentives predicted by behavioral theory and documented by empirical research. anchoring this balancing test in the precautionary principle requires decisionmakers to more actively engage the public health evidence base to overcome the presumption against interventions that trigger unintended consequences. this balancing test favors surveillance policies and program designs that are narrowly tailored in scope, access privileges, and data use only so far as to serve their express public health purpose. vi. conclusion patient confidentiality is a matter of normative importance, especially when it comes to protecting the most vulnerable patients. on the population level, stigmatization, ideology and violations of patient confidentiality can create a deadly mix. guided by the precautionary principle, we must design surveillance systems like pdmps in ways that avoid doing more harm than good. deploying these programs in ways that facilitate patient abandonment and criminalization must give way to a reorientation towards engaging patients and improving care coordination. without doing the hard work to actually help those who need it—and when they need it—most, prescription drug monitoring programs and policies threaten to continue fuel america’s overdose crisis. 186 indiana health law review [vol. 15:139 appendix i: figure 1. the diffusion of prescription drug monitoring legislation in united states 1999-2017 287 287. see supra note 23. 2018] deploying prescription drug monitoring 187 table 1. narrative summary of peer-reviewed studies assessing pdmp impact (2010-2018) digital health privacy and age: quality and safety improvement in long-term-care rachel zuraw* tara sklar** table of contents introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 i. sensor technology in long-term care. . . . . . . . . . . . . . . . . . . . . . . . . 86 ii. quality improvement with client feedback model. . . . . . . . . . . . . . 87 a. gathering data on quality of care. . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 b. cost-savings and workforce shortages.. . . . . . . . . . . . . . . . . . . . . . . . 91 iii. privacy and data protection with digital health. . . . . . . . . . . . . . 93 iv. meaningful informed consent with cognitive aging. . . . . . . . . . . . 96 v. conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 introduction “with enormous governmental expenditures for community-based, long-term care taxpayers and their representatives will demand quality as the ever-growing number of consumers of these services.”1 professor eleanor kinney pioneered an area of research in community-based, long-term care that is at a critical point today: the standardization of services to ensure quality and safety, along with individualization based on patient preferences. kinney defines “community-based, long-term care” as health and personal care that supports daily living activities, is delivered over a sustained period to persons who have lost some capacity for self-care, and has the primary goal to prevent premature institutionalization.2 delivering this basic and fundamental care in the private home and the local community is less costly than providing it in an institution; however, it still faces impediments such as workforce challenges, rising costs, and concerns with the increasing prevalence of elder abuse.3 as the population ages and the number of older americans managing multiple chronic conditions grows, it is essential to develop additional * j.d., m.be, lecturer, university of california, berkeley, school of law. ** j.d., m.p.h., professor of health law, university of arizona james e. rogers college of law. 1. eleanor d. kinney et al., quality improvement in community-based, long-term care: theory and reality, 20 am. j.l. & med. 59, 60 (1994) [hereinafter kinney et al., theory and reality]. 2. id. at 61, 69. activities of daily living (adls) include eating, bathing, toileting, and dressing. 3. tara sklar & rachel zuraw, preparing to age in place: the role of medicaid waivers in elder abuse prevention, 28 annals health l. & life sci. 195, 196 (2019). 86 indiana health law review [vol. 17:85 resources to provide sustainable community-based, long-term care. sensor monitoring technologies provide a promising avenue for improving access to such care, with developers making major breakthroughs in the provision of long-term care at both senior residential facilities and directly in the home. we are seeing a growth in the use of sensors to reduce staffing, enable older adults to have a greater degree of self-management, and manage overall costs. the advantages of sensor monitoring technology are not, however, without their risks: the necessary trade-offs between innovation and privacy are heightened when applied to an older population where decreased cognitive function plays a larger role. while there is emerging scholarship on sensor privacy concerns in health care and for patient data sharing, there is limited literature that explores sensor privacy and consent practices for these devices by seniors in long-term care settings.4 this article is dedicated to the forward-looking insights generated by kinney’s research to improve quality and safety in community-based, long-term care and investigates how the use of sensor technology can be optimally integrated with privacy protections to support this goal. i. sensor technology in long-term care sensor monitoring technologies have been steadily rising in popularity and are now touted as one of the great hopes to sustainably care for a growing aging population.5 the common types of sensors used in long-term care are ambient sensors that can be installed in the home and wearable sensors or ‘wearables’ that can be worn on the body or clothing. both types of sensors provide continuous monitoring with ambient sensors geared more towards observing the environment (e.g., motion detection, object contact, sounds, pressure, temperature) and wearables measuring an individual’s health status, such as heart rate, respiration rate, and muscle movements. estimates predict another surge in use over the next few years, which expects the market for wearables to double to a $27 billion market by 2022.6 both ambient sensors and wearables are being used in a range of ways to support activities of daily living (“adls”), detect falls, and health status monitoring. they are implemented in all kinds of devices, ranging from steady eating utensils to tools that facilitate medication adherence or provide warnings to caregivers if individuals wander from a safe area, and more.7 in particular, 4. md. zia uddin, weria khaksar & jim torresen, ambient sensors for elderly care and independent living: a survey, 18 sensors 2027, 2048 (2018). 5. id. at 2028. 6. see paul lamkin, smart wearables market to double by 2022: $27 billion industry forecast, forbes (oct. 23, 2018, 8:04 am), https://www.forbes.com/sites/paullamkin/2018/ 10/23/smart-wearables-market-to-double-by-2022-27-billion-industry-forecast/#3583a50c2656 [https://perma.cc/cll3-sgcx]. 7. there are numerous sensors available to detect and predict falls. walabot is an example of an ambient sensor that is wall-mounted and can be used to detect falls, whereas walkjoy is a wearable that claims to be able to reduce falls by stimulating nerve activity in the legs and feet. 2020] digital health privacy and age 87 wearables are rapidly increasing in their abilities to collect a growing range of physiological functions—such as brain activity, hydration levels, blood pressure, stress, and blood glucose, to name a few—which can be used to manage chronic conditions by tracking overall health and wellness.8 how do these sensors work? they collect raw data from their continuous monitoring and input it into the device’s algorithm, which is then uploaded via a bluetooth or wireless connection to a server for further processing, including the use of machine learning to determine the current status of the user.9 data may be collected in real-time, at scheduled intervals, or through proximity-based uploads.10 the collected data may be used for regular vital sign monitoring, alerting users and caregivers of risky situations, and signaling when medical attention may be needed. there is a developing awareness among sensor product developers and researchers that older adults may prefer ambient sensors over wearables due to physical discomfort with long-term skin attachment and weight from the devices.11 additionally, some studies have observed that older adults with dementia may remove wearables from their bodies because they forgot their purpose or found them too invasive.12 in general, non-invasive sensors, whether ambient or wearable, should strive to be acceptable to older adults in order to avoid risk of rejection. meanwhile, those operating long-term care facilities as well as senior living communities, are actively incorporating sensors to enable individuals with diminished physical or rational capacity to live independently for a longer period with less full-time supervision. this type of sensor technology may be the missing key for community-based, long-term care to realize its full potential in preventing premature placement in institutional care. and given that this technology is already largely in place and growing, our legal protections must catch up. ii. quality improvement with client feedback model one critical consequence of the move to an aging in place or in-home care carepredict uses temperature sensors to monitor adls and has an assistance button feature to alert caregivers with a two-way audio communication feature. these sensors enable seniors to largely care for themselves and have access to support when necessary. 8. see e.g., caroline saunders, balancing innovation and regulation: why the fda should adopt a more dynamic risk-based system for wearables, 58 jurimetrics: j.l., sci. & tech. 83 (2017). 9. uddin et al., supra note 4, at 2048. 10. see generally christophe mombers, kathleen legako & annette gilchrist, identifying medical wearables and sensor technologies that deliver data on clinical endpoints, 81 brit. j. clinical pharmacology 196, 198 (2015), https://bpspubs.onlinelibrary.wiley.com/doi/pdf/ 10.1111/bcp.12818 [https://perma.cc/8n6b-qmgj]. 11. uddin et al., supra note 4, at 2033, 2047. 12. id. at 2033. 88 indiana health law review [vol. 17:85 model is that it comes with an inherent lack of standardization and transparency. in contrast, facilities that provide long-term care often participate in the medicare program and therefore must comply with the medicare conditions of participation which have an established federal standard for quality of care metrics, staffing, facilities, and services.13 facilities’ oversight by the centers for medicare and medicaid (cms) and their state accreditation agencies are enforced through regular monitoring and reporting.14 individuals receiving care in their communities and homes do not receive the same level of cms oversight and, as a result, are much less likely to be monitored on a regular basis.15 an exception is, effective 2004, all medicare-certified home health agencies are required to participate in quality improvement work by reporting data to the outcome and assessment information set (oasis): the shared data set for medicare beneficiaries employing a home health service.16 this is in part accomplished through 34-question surveys that evaluate care based on the six factors taken from the national academy of medicine to define quality: effectiveness, efficiency, equity, patient centeredness, safety, and timeliness.17 the reporting on these factors is based on outcome measures (defined as an assessment of “the results of health care that are experienced by patients”) and process measures (defined as “the rate of home health agency use of specific evidence-based processes of care”).18 survey data, though, is a far cry from the formal monitoring and reporting that long-term care facilities are required to undergo. home and community-based care therefore presents a unique combination of challenges, as kinney recognized: while it is necessary to establish and maintain 13. 42 c.f.r. § 483.1 (2019). 14. 42 c.f.r. § 483.75 (2019). 15. medicaid home and community-based services (hcbs) waivers support the majority of state aging in place programs and are highly variable with different requirements for caregiver background checks, competencies, and frequency as well as method for oversight visits. some states do not require any site visits by the state case manager and consider periodic phone calls to medicaid recipients as sufficient for adequate oversight. see generally sklar & zuraw, supra note 3. see also sidney d. watson, from almshouses to nursing homes and community care: lessons from medicaid’s history, 26 ga. st. u.l. rev., 937, 963-64 (2010) (describing states’ flexibility in how they tailor waivers and their covered services). 16. vincent mor, improving the quality of long-term care with better information, 83 milbank q. 333, 336-37 (2005); home health quality reporting program, ctrs. for medicaid & medicare serv. (last modified june 5, 2019), https://www.cms.gov/medicare/qualityin it iat ives-patien t-assessment-instruments/homehealthqualityin its/ index.h tml [https://perma.cc/yb92-d6yh]. 17. home health quality reporting program, ctrs. for medicaid & medicare serv. (june 5, 2019, 9:53 pm), https://www.cms.gov/medicare/quality-initiatives-patient-assessmentinstruments/homehealthqualityinits/index.html [https://perma.cc/7ru3-phsl]. 18. home health quality measures, ctrs. for medicaid & medicare serv. (may 30, 2019), h t tps:/ /www.cms.gov/medicare/quality-in it iat ives-patien t-assessmentinstruments/homehealthqualityinits/home-health-quality-measures.html [https://perma.cc/43jbs2g2]. 2020] digital health privacy and age 89 a standard of care to ensure quality and safety and that individuals are not neglected, the care provided is inherently individualized. older adults frequently prefer to stay in their own homes precisely because they desire independence and freedom of choice over their personal care.19 there are two major issues at hand with delivered standardized, individual care: (1) what is meant by “quality of care” and (2) how that quality can be maintained or improved. a. gathering data on quality of care in looking at the first issue, we second kinney’s emphasis that home-based and community-based care services are focused on maintaining adls.20 assistance with adls is largely attendant care, rather than medical care, so does not require qualified medical professionals to perform.21 kinney specifically noted that a focus on outcome-based analysis to determine the quality of care is fundamentally flawed in the long-term care context: no matter how excellent the program, the recipient’s condition will inevitably decline due to age.22 the true measure of the quality of long-term care, kinney describes, is whether and how it relieves the burden of suffering and activities of daily living.23 the personal nature of the care provided makes the satisfaction of the recipient a critical metric in determining “quality” of assistance with adls. kinney and her coauthors evaluated two different models for garnering quality of care data that could be used to fuel improvements: the client feedback model and the normative treatment planning model.24 the former requires a continuous flow of information from recipients of long-term care to receive an evaluation by a monitoring team who attempts to preserve individualized care and share the information back to the recipient.25 the latter calls for increased work standardization at the outset, with care plans addressing most needs and the 19. see generally nat’l acad. of sci., eng’g, & med, artificial intelligence applications for older adults and people with disabilities: balancing safety and autonomy: proceedings of a workshop in brief, nat’l acad . press ., (may, 2019), http://nap.edu/25427 [https://perma.cc/yn8s-etba]; michael k. mcchrystal, the privacy of elders, 2 marquette elder’s advisor 22 (2012). 20. kinney et al., theory and reality, supra note 1, at 61. 21. bridget haeg, the future of caring for elders in their homes: an alternative to nursing homes, 9 naela j. 237, 252 (2013) (“[b]ecause personal care is not medical care in the traditional sense, it is inappropriate to apply the medical definition of quality to these services”); homeand community-based services, ctrs. for medicaid & medicare serv. (dec. 5, 2017) https://www.cms.gov/outreach-and-education/american-indian-alaska-native/aian/ltss-tacenter/info/hcbs.html [https://perma.cc/p6wu-k5st]. 22. kinney et al., theory and reality, supra note 1, at 66-67. 23. id. at 69; see also rosalie a. kane & robert l. kane, long-term care: variations on a quality assurance theme, 25 inquiry 132, 132-34 (1988). 24. kinney et al., theory and reality, supra note 1, at 63-73. 25. id. at 71-73. 90 indiana health law review [vol. 17:85 providers evaluating the outcomes with each client.26 these models represent an essential tension between the focus of quality in home-based care and whether it will be measured based on the recipient experience or predictive, quantitative metrics. at the time of kinney’s initial research more than twenty-five years ago, she concluded that “one drawback of the [continuous feedback model] is that feedback cannot be provided on a continual basis as long-term care clients are not really in a position to provide continuous feedback.”27 at the time, such feedback would have required care recipients—many of whom have reduced capacity—to fill out forms or complete interviews after receiving care, which is unrealistic on an ongoing basis. this is doubtless a major reason for the adoption of the ongoing normative and quantitative model by cms, as represented by the oasis system.28 even though cms continues to rely on the oasis and recipient survey data, change is on the horizon with sensor technology advances. continuous feedback is now possible in the delivery of long-term care.29 care recipients’ health status and behavior can be observed effectively and affordably through sensor monitoring technologies, which could bring kinney’s continuous feedback model to fruition. these technologies have the ability to collect millions of potential data points on a person, ranging from their physical movements to brain activity and hydration levels, that may link overall health outcomes with the appropriate level of care. the promise of these tools to prolong independent living in the home and community is clear, but the depth and detail of personal health data generated by this technology, even to a care team, inherently creates privacy concerns. what is quality in the context of community-based, long-term care? while the six factors used by cms are laudable, we propose a critical, seventh factor: compliance with the recipient’s goals for their own care. most recipients of longterm care are fully rational individuals capable of setting their own goals for care and defining their own quality of life. oasis surveys make an attempt to incorporate the satisfaction of care recipients through the category of “patient willingness to recommend [the home health agency] to family and friends,” but this does not go far enough.30 we, therefore, find the advantages of the client feedback model to be the most compelling in this context. as noted by kinney and her coauthors, it presents the following advantages: it is from the recipient’s perspective (remember, this is provision of care rather than treatment of a disease); it allows for evaluation of the trustworthiness of caregivers; and the iterative nature enables continuous improvement, rather than updates to 26. id. at 71, 74. 27. see id. at 73. 28. vincent mor, improving the quality of long-term care with better information, 83 the milbank quarterly 333, 336-37 (2005); home health quality reporting program, supra note 17. 29. supra section i. 30. home health quality measures, supra note 18. 2020] digital health privacy and age 91 generalized plans.31 while kinney had to caveat these advantages in 1994 by pointing out that collection of personal data was impeded by the lack of resources on the part of most care providers to continually interview clients and the clients’ own memory problems,32 we can now collect real-time data and impressions via sensors to address those concerns. another avenue explored by professor kinney in her later work is comparative effectiveness research.33 her research primarily looked at the establishment of the patient-centered outcomes research institute (the “institute”) through title xi of the social security act and title ix of the public health service act.34 the purpose of the institute includes a statutory duty to conduct and support research and evaluations of patient care, including long-term care.35 the institute currently supports multiple projects relevant to long-term care and aging in place, including thirty-six comparative clinical effectiveness research studies focused on older adults’ health and thirteen studies focused on dementia and cognitive impairment.36 b. cost-savings and workforce shortages aside from the fundamental difficulties of determining and improving upon the quality of care, in the home-based context, there are serious shortages of both money and staff to maintain the necessary level of care. medicaid is the primary payor of home-based care services in the united states.37 cost-containment is necessary to sustain the budget-constrained medicaid program to serve the older generations now and in the years ahead and enable states to effectively serve their eligible populations. this provides yet another argument in favor of incorporating sensor technology to make home health care accessible to more individuals. the utilization of sensor monitoring technology to incorporate feedback for individual preferences and satisfaction levels over time has the potential to greatly reduce redundant and unnecessary care, thereby containing costs. this type of feedback model aligns with the concept of continuous quality 31. kinney et al., theory and reality, supra note 1, at 73-74. 32. id. 33. see generally eleanor d. kinney, comparative effectiveness research under the patient protection and affordable care act: can new bottles accommodate old wine?, 37 am. j.l. & med. 522 (2011). 34. id. at 544-66. 35. 42 u.s.c. §1320e(b) (2019). 36. see dementia and cognitive impairment, patient-centered outcomes res. inst., https://www.pcori.org/topics/dementia-and-cognitive-impairment [https://perma.cc/8kyh-k29w]; older adults’ health, patient-centered outcomes res. inst., https://www.pcori.org/topics/ older-adults-health [https://perma.cc/n9ks-b4bv]. 37. sklar & zuraw, supra note 3, at 196. see also kirsten j. colello, cong. research serv., if 10343, who pays for long-term services and supports? (2018), https://fas.org/sgp/ crs/misc/if10343.pdf [https://perma.cc/p2fr-pexk] (“medicaid is the largest single payer of ltss in the united states.”). 92 indiana health law review [vol. 17:85 improvement—systematically measuring and iteratively improving recipient satisfaction—as quality improvement is defined and measured from the recipient perspective.38 the collection of dense physiological data may identify early safety issues in regards to overall health and managing chronic conditions.39 older adults can regularly add their voice to the data collected, and help identify potential areas of concern with their health status or difficulties. workforce shortages in the long-term care are not a new phenomenon, but there are signs of improvement.40 while we have not yet reached the inflection point at which adoption of sensors and other technology can substitute for staff coverage, many experts anticipate significant cost savings once we reach that point.41 at the present time many long-term care patients, whether in facilities or in their own homes, require regular, in-person check-ins to monitor their health. once it is possible to reliably monitor vital statistics and comfort via sensors, a smaller staff of caregivers will be able to provide care to far more individuals. we are seeing the beginnings of this trend with in-home caregiving services managed via smartphone applications and anticipate that it will only grow.42 38. see, e.g., kinney et al., theory and reality, supra note 1. 39. see home health quality measures, supra note 18. see also office of disease prevention and health promotion, older adults, healthy people, https://www.healthypeople.gov/2020/ topics-objectives/topic/older-adults [https://perma.cc/2cur-6cw5]. 40. see generally institute for the future of aging services, the long-term care workforce: can the crisis be fixed? (jan. 2007), https://www.leadingage.org/sites/ default/files/ltc_workforce_commission_report.pdf [https://perma.cc/j9qc-u5n6]; see also eduardo porter, home health care: shouldn’t it be work worth doing?, n.y. times (aug. 29, 2017), https://www.nytimes.com/2017/08/29/business/economy/home-health-care-work.html [https://perma.cc/uv7y-f4j8]; yvonne rickert, how to plan ahead for labor shortages in senior living, life care services (jan. 11, 2017), https://www.senior-living-management.com/how-toplan-ahead-for-labor-shortages-in-senior-living/ [https://perma.cc/b3ez-fxg7]; alex kacik, nursing home staffing levels often fall below cms expectations, modern healthcare (july 1, 2019), https://www.modernhealthcare.com/providers/nursing-home-staffing-levels-often-fallbelow-cms-expectations [https://perma.cc/ywn2-ya9m]. 41. see, e.g., sunghee h. tak et al., technology for long-term care, 3 res. gerontological nursing 61 (2010); see also conner girdley, making long-term care intelligent: ai provides cost-saving solutions that improve the quality of care, lancaster pollard (mar. 13, 2018), https://www.lancasterpollard.com/the-capital-issue/making-long-termcare-intelligent-ai-provides-cost-saving-solutions-that-improve-the-quality-of-care/ [https://perma.cc/ab9q-gbhv]; cf. patricia sheehan, technology takes off in long-term care, iadvance senior care (july 15, 2011), https://www.iadvanceseniorcare.com/technology-takesoff-in-long-term-care/ [https://perma.cc/5647-75u9]. 42. home health care startups such as honor, which connects consumers with caregivers through apps, have secured impressive venture capital backing in recent years—though they have also faced significant regulatory hurdles. see amy baxter, honor raises $50 million to target hundreds of new partners, home health care news (may 22, 2018), https://homehealthcarenews. com / 2 0 1 8 / 0 5 / h o n o r r a i s e s -5 0 -mil l ion -to-t a rge t -h u n dreds -of -n ew -par tn er s / [https://perma.cc/qwc3-w8zn]; jonah comstock, senior care startup homehero is pivoting 2020] digital health privacy and age 93 iii. privacy and data protection with digital health in exploring the advantages of incorporating monitoring technology into long-term care, we must also acknowledge the risks regarding personal health data that is continuously collected, stored indefinitely, and shared with minimal safeguards in place. irrespective of a beneficial purpose, we must consider how this data may be protected. the current debate among privacy laws in the united states and abroad governing personal data protection is increasingly relevant for digital health.43 advocates believe this type of technology will reduce inefficiencies, increase quality, and make health care more responsive to individual preferences. detractors believe that it will leave vulnerable individuals open to profiling for predatory marketing and hacking. lawmakers in the european union and california have created the current marquee laws for protecting personal data with the passage of the general data protection regulation (gdpr) and california consumer privacy act (ccpa), both of which call for greater transparency and stronger individual rights over personal data. the gdpr and ccpa are at the forefront of privacy legislation with their efforts to overhaul the status quo and provide principles for how data collection and processing should occur. the gdpr was passed by the eu in 2016 and went in effect in may 2018 across 31 countries, with implications for any entity that processes data from an eu resident.44 there are seven key principles laid out in the gdpr for processing of personal data: “[l]awfulness, fairness and transparency; purpose limitation; data minimization; accuracy; storage limitation; integrity and confidentiality (security); [and] accountability.”45 the underlying ideals of the gdpr that have gained the most traction in recent united states lawmaking can be summarized as follows: (1) a person’s data may only be collected for a specific purpose; (2) the person must be informed of and consent after regulatory hurdles, mobile health news (feb. 28, 2017), https://www.mobihealthnews. com /con ten t / sen ior -ca re -s t a r tu p-h omehero-pivotin g-a f t e r -regu la to ry-h u rd les [https://perma.cc/u6wj-yce4]. 43. digital health is defined as technologies that provide data collected by health sensors, devices, and other tools which consumers, their caregivers as well as health care providers can use to better manage health outcomes and wellness related activities. see generally food and drug admin., digital health innovation action plan (2017), https://www.fda.gov/media/106331/ download [https://perma.cc/c3eq-ak5j]. 44. there are 28 eu member states and 31 states that are part of the european economic area. there are additional countries that the eu commission recognizes as providing an adequate level of data under its “adequacy” status in art. 45 of the gdpr. see adequacy decisions: how the eu determines if a non-eu country has an adequate level of data protection, european commission, https://ec.europa.eu/info/law/law-topic/data-protection/data-transfers-outsideeu/adequacy-protection-personal-data-non-eu-countries_en [https://perma.cc/dj3p-5aec]. 45. info. comm’n off., guide to the general data protection regulation, in guide to data protection, https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-thegeneral-data-protection-regulation-gdpr/ [https://perma.cc/44qw-c6n6]. 94 indiana health law review [vol. 17:85 to the purpose for which their data is collected; (3) only as much data as is necessary to achieve that purpose should be collected; (4) the collected data must be deleted at the request of the person from whom it was collected, or when it is no longer needed for the purpose for which it was collected.46 the ccpa was signed by governor brown on june 28, 2018 and went into effect on january 1, 2020. although not as extensive in scope as the gdpr, it is arguably the strongest u.s. consumer privacy law to date and also an outcome of the gdpr’s influence. the ccpa provides a legal framework to protect personal data, though solely for california residents. it limits its applicability to cover only large entities with $25 million or more in gross revenues, processing data of 50,000 consumers, and 50% of revenue from data sales.47 ccpa also provides consumers with the right to know where data is collected and to whom it is sold, as well as the right to disclosure. a major divergence between the gdpr and ccpa and point of contention among state privacy laws is whether to have opt-in or opt-out consent. this controversy impacts the informed consent processes that long-term care operators may choose to adopt. the gdpr requires opt-in consent, which means individuals must provide consent to have their data be processed (collected and used). the ccpa, by contrast, uses an opt-out approach, which enables consumers to, at any time, opt-out from having their personal data sold.48 critics of the gdpr claim the opt-in approach stymies innovation as it would be more costly to implement and lead to delays; they also question whether an opt-in approach protects individuals’ privacy.49 advocates for the opt-in approach believe it is not possible to meaningfully opt-out as individuals are largely unaware of the amount of personal information about them that is being collected and assert that opt-out consent can be exploitative and erode trust.50 while gdpr and ccpa are currently at the forefront, as the popularity of digital health increases so do the efforts by federal and state governments to propose legislation allowing health technologies to flourish without (theoretically) compromising privacy. for example, there is presently a bipartisan bill in the senate—senate bill 1842, the protecting personal health data act—which specifically addresses data collected from health tracking devices and applications.51 this bill has implications for those that provide long-term care 46. see id. 47. see cal. civ. code § 1798.140(c) (west 2019) (effective jan. 1, 2020). 48. cal. civ. code § 1798.120(a) (west 2019) (effective jan. 1, 2020). 49. see law.com, privacy notices, opt-in clauses debated as us regulators shape federal privacy law, yahoo! finance (mar. 12, 2019), https://finance.yahoo.com/news/privacy-noticesopt-clauses-debated-041541572.html [https://perma.cc/ab5k-tm4m]. 50. see id. see also antonio garcia martinez, why california’s privacy law won’t hurt facebook or google, wired (aug. 31, 2018), https://www.wired.com/story/why-californiasprivacy-law-wont-hurt-facebook-or-google/ [https://perma.cc/a5uc-5ng4]. 51. see protecting personal health data act, s. 1842, 116th cong. (2019) (the bill was introduced in response to a 2016 report issued by the department of health and human services entitled “examining oversight of the privacy & security of health data collected by entities not 2020] digital health privacy and age 95 and are looking to adapt business models to further rely on sensors in the monitoring of wellness and delivery of care. the bill directs the department of health and human services (dhhs) to create regulations that strengthen privacy for data collected by consumer devices. this would include establishing standards for consent for the handling of personal health and other data and improving the ability of individuals to navigate their health privacy options, including by amending or deleting copies of their personal health data. if senate bill 1842 or a comparable version passes, long-term care providers may be held to similar expectations as business currently operating under the gdpr: they would need to have transparent policies around what data they are collecting and for what purpose, as well as create mechanisms to allow individuals to manage their personal data as requested. individual states are also proposing to regulate digital health, with california at the forefront. california state representatives have drafted the “information privacy: digital health feedback systems” bill, which would expand their current health privacy law to include any information in possession of or derived from a digital health feedback system, which is broadly defined to include sensors, devices, and internet platforms.52 the evolving digital health data protection regulations could benefit from incorporating strategies that align with kinney’s continuous feedback model, described above, which requires a continuous flow of information from recipients of long-term care to be evaluated by a monitoring team that would strive to preserve individualized care and loop back to the recipients.53 emerging regulations around digital health could treat long-term clients as part of a circular process in the collection, analysis, and protection of personal data. preliminary studies have examined privacy concerns among older users of mobile sensor technologies.54 concerns regarding trust and control predominated; seniors emphasized the importance of knowing what kinds of personal data are being collected, for what purpose, and over what time period, and expressed a desire to limit use for commercial purposes. they also emphasized concerns regarding security, including protection against breaches and disclosure should a breach occur. potential issues also arose regarding the accuracy of data and the ability to amend, if needed, for protection against potential discrimination in obtaining equitable insurance (health, life). these concerns are all highly relevant to the current privacy debate across the country and abroad. there are noted sensitivities among older adults regarding the continuous use of sensor monitoring technologies. survey respondents expressed apprehension regarding how invasive they might be, even if they offer the ability to live independently over a longer period. the consent process may be a way to engage regulated by hipaa”). 52. see a.b. 384, reg. ses. 2019–2020 (cal. 2019). 53. see kinney et al., theory and reality, supra note 1, at 71-73. 54. see e.g., sofia siggelin, seniors privacy concerns in health technology wearables: regulations vs. user concerns, (2017) (unpublished b.a. thesis, luleå university of technology) http://www.diva-portal.org/smash/get/diva2:1104482/fulltext03 [https://perma.cc/xx4lcszk]. 96 indiana health law review [vol. 17:85 older adults by being responsive to their concerns regarding trust and control of their personal data and encourage higher levels of voluntary participation. a clear consent process, whether it is opt-in or opt-out, combined with kinney’s continuous feedback model may offer a unique approach in which older adults could experience an increased level of comfort with the collection and use of their personal data because they are part of the quality improvement cycle. iv. meaningful informed consent with cognitive aging data collection and consent has been the focus of outpourings of scholarship in recent years, as well as ongoing research and advocacy projects.55 to date, however, there has been a serious dearth of scholarship surrounding meaningful consent by older adults in the digital health privacy context. this underexamined area is particularly important now that sensor technology is making its way into homes and long-term care facilities.56 there are unique privacy interests for older adults that can and should be addressed separately from those of other groups of adults due to the complications of cognitive aging. normal aging has been widely observed to come with cognitive changes, even where dementia or cognitive impairment are not present.57 of particular note are findings that past aged 70, an individuals’ ability to maintain mental flexibility diminishes and they are less able to engage with new or abstract concepts.58 these are precisely the areas of cognition that are taxed by determining whether to consent to data collection, given the need to imagine possible future uses (both positive and negative) of one’s personal data. one of the most compelling proposals for ameliorating consenting problems is the use of dynamic consent procedures. dynamic consent requires personalized consent paired with a communication platform intended to facilitate an ongoing communication as part of the evolving consent process.59 this has become increasingly popular in recruiting biobanking participants due to its ability to improve inclusivity through tailored engagement.60 neither the gdpr nor the 55. see generally, e.g. chris jay hoofnagle, assessing the federal trade commission’s privacy assessments, 14 ieee sec’y & privacy 58 (mar. 2016) (for a small, though prominent sample); paul schwartz, legal access to global cloud data, 118 columbia l. rev. 1681 (2018); technology and civil liberties, aclu northern california, https://www.aclunc.org/issue/ technology-and-civil-liberties [https://perma.cc/7ha2-a4z7]. 56. see supra section i. 57. see, e.g., caroline n. harada, marissa c. natelson love & kristen triebel, normal cognitive aging, 29 clin. geriatric med. 737, 738 (2013). 58. id. at 741. 59. isabelle budin-ljosne et al., dynamic consent: a potential solution to some of the challenges of modern biomedical research, 18 bmc med. ethics art. 4 (2017), h t tps:/ /bmcmedeth ics.biomedcen t r a l . com/ar t ic les/10 .1186/s12910-016-0162-9 [https://perma.cc/ass7-6ztk]; mary a. majumder, et al., the role of participants in a medical information commons, 47 j.l. med. & ethics 51, 53 (2019). 60. see, e.g., megan prictor, harriet j.a. teare & jane kaye, equitable participation in 2020] digital health privacy and age 97 ccpa currently requires the use of dynamic consent, but it could provide needed clarity as well as support for research and innovation goals. dynamic consent procedures would dovetail well with the incorporation of sensor technology into senior care, and it would be a seemingly small step to incorporate ongoing communication to facilitate consent. sensor technology is able to incorporate a two-way, ongoing communication that could potentially assist with both health status monitoring and simultaneous check-ins regarding the individual’s comfort with the usage of their data. privacy laws do not, unfortunately, currently account for a decline in cognitive functioning as people age. notably, both the gdpr and the ccpa have a special carve-out for children under 16 years of age preventing their data from being collected without their affirmative consent (or, if under 13, the affirmative consent of their parent or guardian). while it has long been acknowledged that minors have different privacy interests than adults, adults with diminished rational capacity—e.g., seniors suffering from dementia or alzheimer’s disease—are in a different, yet unrecognized, category when it comes to the use of sensor technology for continuous monitoring. children have not yet reached full decision-making capacity, whereas some older adults may no longer have the same decision-making capacity that they once held. despite the parallels, older adults with diminished cognition should not be placed in the role of children under these privacy regimes. demonstration of respect for the personhood of older adults requires that their needs and preferences, as individuals with extensive decision-making histories, be taken thoroughly into account. this may be done through intervention of informed guardians, the dynamic consent procedures detailed above, or some other means—but regardless, it is an important area of future study if we are to employ these technologies to improve long-term care. v. conclusion this article expands on issues identified in kinney’s scholarship to shed light on the delicate balance of equities between privacy and access to care raised by the incorporation of sensors to monitor the care, health, and daily activities of older adults. while we have used this space to explore prevalent legal and ethical considerations around the increasing use of sensor monitoring technologies to support quality and safety improvements in community-based, long-term care, our primary intent is to flag critical questions for future study. the continuous feedback model proposed by professor kinney and her coauthors twenty-five years ago can provide a blueprint for how to provide care that is truly responsive to the needs and desires of older adults. but before diving headlong into that future, it is imperative for both scholars and technology biobanks: the risks and benefits of a “dynamic consent” approach, 6 front pub. health 253 (2018). 98 indiana health law review [vol. 17:85 developers to consider how we are regarding and preserving the privacy interests of older adults. it is important to act sooner rather than later in this uncertain environment to establish clear processes around meaningful informed consent, data collection, and utilization as digital health continues to evolve and become a reality for community-based, long-term care. codified disparity: the medicaid imd exclusion, mental health parity, and congressional intent indiana health law review volume xxi 2024 number 2 articles codified disparity: the medicaid imd exclusion, mental health parity, and congressional intent j. michael e. gray * table of contents i. introduction ii. the medicaid imd exclusion a. impact of the imd exclusion b. inherent discrimination of the imd exclusion iii. parity: congressional intent to bring health justice for people with mental health conditions a. rehabilitation act of 1973 b. americans with disabilities act of 1990 c. mental health parity and addiction equity act of 2008 iv. the imd exclusion as mental health disparity: the subjectivity of generality v. conclusion i. introduction wilbur mills had a problem. he was a southern democrat in a time when democrats spearheaded fiscal conservatism in the united states house of representatives, and a president from mills’ own party was flipping the narrative by which parties, regions, and ideologies drove federal spending on social benefits for low-income americans. 1 president lyndon johnson was hell————————————————————————————— * j. michael e. gray is deputy director of nami maryland (the national alliance on mental illness) and former director of advocacy at the treatment advocacy center. he holds a j.d. from the brandeis school of law at the university of louisville and has taught political science at simmons college of kentucky. this article is based on a presentation he gave on oct. 21, 2022, at the indiana health law review symposium. the author thanks the staff of the indiana health law review and the faculty and staff of the robert h. mckinney school of law, lisa dailey for feedback on the first draft, as well as elizabeth sinclair hancq and sabah muhammad for feedback on the concepts discussed herein. he also thanks his family for their patience and support. 1. see julian e. zelizer, how medicare was made, the new yorker (feb. 15, 2015), https://www.newyorker.com/news/news-desk/medicare-made [https://perma.cc/jc9e-9vvm]. https://perma.cc/jc9e-9vvm https://www.newyorker.com/news/news-desk/medicare-made indiana health law review [vol. 21:227 228 bent on passing some form of publicly funded healthcare in the wake of his landslide 1964 reelection victory. 2 mills was chair of the powerful house ways and means committee. he opposed the public healthcare funding mechanism accompanying johnson’s legislation—increases in social security taxes—and had spent the better part of two decades blocking any substantive bills on the topic from coming to a vote in his committee. 3 mills may have believed that he staved off momentum from his more progressive colleagues by passing the kerr-mills act in 1960—a watered down approach that allowed states to opt in to limited health coverage for low income seniors. kerr-mills used matching state funds based on a given state’s per capita income. 4 his plan failed to effectively provide coverage for vulnerable americans due to its shaky funding scheme and lack of a nationwide mandate. 5 it also failed to placate progressives on capitol hill and the white house because it did not adequately provide healthcare services. 6 mills was a physically unassuming man but a shrewd political operator with a mind suited for solving the complex fiscal issues facing congress in a complicated political environment. he may have switched in and out of his native southern accent depending on whether he was speaking to constituents in central arkansas or washington’s elite, and some contemporaries believed that he read the federal tax code in his leisure time. 7 his principle concern with the program that became medicare was that it would raise social security taxes to an unconscionably high rate, 8 but he was losing fiscal conservative allies in the house and on his committee. a slew of new, more liberal members of congress ————————————————————————————— 2. johnson defeated arch conservative senator barry goldwater of arizona in 1964 by an electoral margin of 486-52. johnson had more legislative experience than any president of the twentieth century up to that point; he instinctively knew he had a short window to pass controversial and expensive legislation. see generally irwin unger, the best of intentions: the triumph and failure of the great society under kennedy, johnson, and nixon (1996); julian e. zelizer, the fierce urgency of now: lyndon johnson, congress, and the battle for the great society (2015). 3. congressional committee chairs control the agenda for their committees, and therefore control which bills reach the house and senate floors. see generally the committee system in the u.s. congress, cong. rsch. serv. 2 (oct. 14, 2009), https://www.everycrsreport.com/ files/20091014_rs20794_64d74bfc8f8aa83aafb5b05ee700eda5db27eb2d.pdf [https://perma.cc/ tt5b-d7nw]. 4. social security amendments of 1960, pub. l. no. 86-778, 74 stat. 924, 924 (1960). 5. see medicare and medicaid at 50: america’s entitlement programs in the age of affordable care (alan b. cohen et al., oxford univ. press 2015); judith d. moore & david g. smith, legislative medicaid: considering medicaid and its origins, 27 health care fin. rev. 45 (2005). 6. id. 7. medicare and medicaid at 50, supra note 5, at 13 (mills’ intermittent southern accent); zelizer, supra note 1. 8. moore & smith, supra note 5, at 50; medicare and medicaid at 50, supra note 5, at 913. https://perma.cc https://www.everycrsreport.com 2024] codified disparity 229 adroitly rode johnson’s coattails into power in january 1965.9 mills worked with a closeknit group of fiscal and healthcare policy experts in the executive and legislative branches and concocted a compromise: two tiers of medicare would pay for hospital treatment and doctor visits (medicare part a and b, respectively), and a third piece would build upon the shared state/federal funding model of kerr-mills to offer health coverage to low-income individuals. 10 this would be enough for progressives looking to help less fortunate americans but might still be just barely too expensive for the collective conscience of fiscally conservative southern democrats. one more compromise made it into medicare and medicaid’s enabling legislation: denying coverage for two subcategories of people living below the poverty line—people with psychiatric conditions and people who are incarcerated—two broad groups of people whose healthcare was apparently expendable for the 89th congress.11 since the earliest days of what is now the united states, justice-involved persons (particularly incarcerated individuals) and people living with the more severe cases of mental illness have occupied an egregiously low level of society. congress chose to cut them out of medicaid coverage via two distinct subsections within the social security amendments of 1965. 12 the two exclusions were drafted hastily, almost as afterthoughts, 13 and likely also to push the budget math back into the black, but it cannot be a coincidence that two populations already relegated to the margins of american society did not earn health coverage in the twentieth century’s preeminent healthcare legislation. congress did not think they mattered enough to be included. congressional intent, however, is not static. the legislative body meant to represent the nation’s citizenry and make incarnate its collective will change its mind regularly. it grows; it evolves. congress has even blatantly countermanded its own policies, usually after shifts in public opinion. 14 when congress created ————————————————————————————— 9. benjamin j. guthrie, statistics of the presidential & congressional election of no. 3, 1964, u.s. gov’t printing office (1965), https://clerk.house.gov/member_info/electioninfo/ 1964election.pdf (showing a net democrat gain of 36 seats from the 1964 u.s. house elections). 10. social security amendments of 1965, pub. l. no. 89-97, 79 stat. 286 (codified as amended in 42 u.s.c. §§ 301 et seq.). 11. 42 u.s.c. § 1396d(a)(31)(a) (2018) (barring medicaid funds from covering healthcare services for “any individual who is an inmate of a public institution”); 42 u.s.c. § 1396d(a)(31)(b) (2018) (barring medicaid funds from covering “care or services for any individual who has not attained 65 years of age and who is a patient in an institution for mental diseases”). 12. id. 13. see j. michael e. gray & madeline easdale, blatant discrimination within federal law: a 14th amendment analysis of medicaid’s imd exclusion, 18 u. mass. l. rev. 165, 171 (2023). 14. the greatest public policy shift in the history of the united states that lead to a reversal in the will of congress was the shift from institutional support of slavery and slave owners to abolition. see generally eric foner, reconstruction: america’s unfinished revolution, 1863–1877 (1988) (a broad discussion of the legal end of slavery and congressional struggles to https://clerk.house.gov/member_info/electioninfo indiana health law review [vol. 21:227 230 medicaid in 1965, it acted somewhat hastily while focusing mainly on medicare. 15 although medicaid was and is badly needed to provide health coverage for millions of americans, certain pieces fell on the proverbial cutting room floor and their absence is having dire consequences nearly six decades later. medicaid’s enabling legislation included two discriminatory provisions that prevent people who are incarcerated, as well as people with illnesses requiring inpatient psychiatric care from receiving the full extent of services needed to treat their ailments. in addition to violating the 14th amendment’s equal protection clause, 16 this latter provision, known as the imd exclusion, directly contradicts more recent congressional intent to treat mental and physical conditions equally under the law. 17 this article examines the history and impact of the imd exclusion, including its questionable origins, its impact on healthcare systems generally, and the resulting deprivations of medically necessary care.18 next, the article discusses the discriminatory effect of the imd exclusion; it denies federal and state funded health coverage for a specific class of individuals while allowing it for everyone else. 19 after quickly codifying that discriminatory rule, congress established a pattern of passing landmark legislation that was more fair and reasonable, intentionally promoting equal and equitable treatment of the very people denied equality under the imd exclusion. 20 the final sections herein provide a chronological description of three pieces of landmark legislation from the decades following medicaid. those subsequent congressional actions were inconsistent with the perpetuance of the imd exclusion, and this article concludes with an argument that congressional intent has evolved enough that the courts can and should act, if congress will not, and end this disparity of healthcare coverage. 21 ii. the medicaid imd exclusion the mid-1960s saw many social movements intersect with political will and result in legislation. the administrations of presidents john kennedy, and to a much greater degree, lyndon johnson, brought social inequity and the federal ————————————————————————————— enforce the mid-nineteenth century sea change in public opinion). abolition and reconstruction remain the most far-reaching change of congressional intent and the most dramatic; it came on the heels of the nation’s deadliest war to date. 15. see infra section ii. (unpacking more of the multilayered compromises that resulted in medicaid). 16. for an analysis of the imd exclusion with respect to the equal protection clause, see gray & easdale, supra note 12, at 175-76. 17. see infra section iii. 18. see infra section ii. 19. see infra section ii.b. 20. see infra section iii. 21. see infra section iv. 2024] codified disparity 231 government’s constitutional ability to counteract it to the fore. 22 voter rights,23 civil rights, 24 and fair housing access 25 all made it into federal code and became perpetually enshrined in the federal budget. the single largest, most impactful, and most expensive 26 piece of legislation from the era was arguably the lowest profile piece of the johnson administration’s great society platform—the social security amendments of 1965.27 the amendments created two publicly funded healthcare coverage plans. medicare would cover people who had reached the age of retirement and medicaid would cover low-income individuals. 28 understanding the present state of the two programs requires an understanding of their political origins. both medicare and medicaid were a continuation of broad new deal priorities stemming from the social unrest and political upheaval of the 1930s. the franklin roosevelt administration’s new deal promised federal resources to provide for seniors and to lift people living in poverty up to a higher economic standard of living.29 after passage of those social programs, healthcare costs rose rapidly in the ensuing decades, and people without employer provided health insurance were largely underinsured. 30 the johnson administration saw those rising costs as a threat to both short term economic stability and long term ————————————————————————————— 22. the kennedy administration had good intentions and played a leading role in advancing the dialogue around equality for marginalized people, particularly black people living under the long-lasting effects of slavery and jim crow. however, the kennedy administration may have lacked the boldness necessary to engage with congress on these initiatives. to be fair, president kennedy had less than three years in office and may well have acted on his more progressive inclinations had he had one or even two full terms. the proceeding administration of president lyndon johnson did not lack boldness and the president had ample experience with the inner workings of congress. almost immediately upon taking office, president johnson began passing legislation to address societal inequities. for a general discussion of the time-period and the legislation it produced. see generally zelizer, supra note 2; robert a. caro, the years of lyndon johnson: the passage of power (2012). 23. voting rights act of 1965, pub. l. no. 89-110, 79 stat. 437 (1965) (codified as amended in 52 u.s.c. §§ 10101-10702). 24. civil rights act of 1964, pub. l. no. 88-352, 78 stat. 241 (1964) (codified as amended in sections of 42 u.s.c. §§ 2000 et seq.). 25. fair housing act of 1968, pub. l. no. 90-284, 82 stat. 73 (1968) (codified as amended in 42 u.s.c. §§ 3601-3631). 26. already expensive upon its initial implementation, the cost of publicly funded healthcare has grown substantially in the decades since 1965. medicare alone is over twice the size of any single private insurer with 2021 expenditures of over $900 billion. see nhe factsheet, ctrs. for medicare & medicaid servs., https://www.cms.gov/research-statistics-data-and-systems/ statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet [https://perma.cc/ 54vq-n3v6] (last modified dec. 14, 2022). 27. social security amendments of 1965, pub. l. no. 89-97, 79 stat. 286 (codified as amended in 42 u.s.c. §§ 301 et seq.). 28. id. at 42 u.s.c. §§ 1396 et seq. 29. see generally arthur m. schlesinger, jr., the age of roosevelt vol. 2: the coming of the new deal (1958). 30. see rosemary a. stevens, health care in the early 1960s, 18 health care fin. rev. 11 (1996). https://perma.cc https://www.cms.gov/research-statistics-data-and-systems indiana health law review [vol. 21:227 232 economic prosperity for millions of people. 31 congressional liberals wanted what would today be called a single-payor health plan, financed by direct taxation and administered by the federal government. 32 more conservative policymakers believed that such a system would be too costly and would fail to see the results promised by leading democrats in congress and the white house.33 congress struck a series of compromises to provide some healthcare for the most vulnerable members of american society without overextending the federal budget. 34 medicare would not cover everyone; it would only cover individuals who had reached the approximate age of retirement. 35 this alone would not have satisfied congressional liberals because the elderly were not the ————————————————————————————— 31. when president johnson signed the enabling legislation, he spoke about the “injustice” of denying “the miracle of healing to the old and to the poor.” see lyndon b. johnson, remarks with president truman at the signing in independence of the medicare bill, the american presidency project (july 30, 1965) https://www.presidency.ucsb.edu/node/241296 [https:// perma.cc/3zt2-aec2]. the new deal had a lasting impact on both the ideologies and career trajectory of president johnson. he saw his great society initiatives as the continuation of progressive policies began under the franklin roosevelt administration, continued at least in spirit by president truman, but never completed. johnson saw many reforms as ripe for completion by the time he became president in 1963. it was a typically grand johnsonian gesture that he signed medicare and medicaid’s enabling legislation alongside former president truman at the truman presidential library in independence, missouri. id.; see also robert a. caro, the years of lyndon johnson: the path to power 526-81 (vintage ed., 1990) (examples of johnson’s work with roosevelt and his role in new deal legislation); zelizer, supra note 1, at 73-74 (describing johnson’s conflicted personal politics on civil rights but his longstanding commitment to the new deal). 32. the movement towards single-payor healthcare in the united states dates at least to the very early twentieth century with roots in the labor movement and workers’ rights. by the 1930s, roosevelt wanted to include healthcare in the social security act but had to push it aside to pay for the statute’s primary goal of income for seniors. see abigail abrams, the surprising origins of ‘medicare for all’, time (may 30, 2019, 2:05 pm), https://time.com/5586744/medicare-forall-history/ [https://perma.cc/j6k4-tvt5]. the first president to call for government funded healthcare was harry truman in his 1949 state of the union address. see harry s. truman, annual message to the congress on the state of the union, the american presidency project (jan. 5, 1949) https://www.presidency.ucsb.edu/documents/annual-message-the-congress-thestate-the-union-21. 33. see julian e. zelizer, the contentious origins of medicare and medicaid, in medicare and medicaid at 50: america’s entitlement programs in the age of affordable care (alan b. cohen et al. ed., oxford univ. press 2015); see also jonathan oberlander & teodore r. marmor, the road not taken: what happened to medicare for all?, in medicare and medicaid at 50: america’s entitlement programs in the age of affordable care (alan b. cohen et al., oxford univ. press 2015); see also discussion of chairman wilbur mills’ political dilemma supra, introduction. 34. see zelizer, supra note 2, at 226 (discussing the rapidly increasing strain of the vietnam war on the federal budget as johnson needed increased spending to cover great society programs). 35. social security amendments of 1965, pub. l. no. 89-97, 79 stat. 286 (codified as amended in 42 u.s.c. §§ 301 et seq.). https://www.presidency.ucsb.edu/documents/annual-message-the-congress-the https://perma.cc/j6k4-tvt5 https://time.com/5586744/medicare-for https://www.presidency.ucsb.edu/node/241296 2024] codified disparity 233 only population unable to cover healthcare expenses. 36 children and adults under retirement age who lived below the poverty line would need coverage as well, but the federal budget could not withstand that level of spending. 37 chairman mills brokered a compromise that would permanently and radically alter the healthcare delivery system in the united states, as well as extend limited but vital healthcare to low-income americans. states would have the option to take part in a program funded jointly by the federal and individual state governments, administered by the state governments through the restrictions of federal guidelines, and it would be incumbent upon the states to enroll and oversee the cases of individuals who qualified.38 this was medicaid. even with a cost-sharing approach, medicaid had the potential to become untenably expensive. poverty was rising in the 1960s and with it rose the number of potential medicaid enrollees. 39 congress sacrificed two subsets of that population, both inherently likely to live below the poverty line. people who are incarcerated and people in need of inpatient psychiatric care have never received full benefits under medicaid due to the resulting inmate exclusion40 and the institutions for mental diseases (imd) exclusion. 41 likely meant as a politically acceptable means to an end of paying for the majority of medicaid eligible individuals, some of the most marginalized people in the united states have been living and dying without medically necessary care due solely to the involuntary status of having a severe mental illness (smi). in 1965, people with smi and other behavioral health diagnoses had long been relegated to the margins of society. 42 psychiatric hospitals or “asylums” varied greatly in standard of care and carried a public perception, somewhat ————————————————————————————— 36. id; social security amendments of 1972, pub. l. no. 92-603, 86 stat. 1329 (1972) (although the 1965 amendments created medicare to extend coverage to the elderly, a second round of amendments in 1972 extended medicare to people ages twenty-one to sixty-four who have been considered disabled by the federal government for at least two years). 37. the total costs of any health plan, whether private insurance of publicly funded programs, include both reimbursements (paying healthcare providers for services) and administrative expenses. medicaid administrative costs are relatively low, about five percent, which is consistent with federal programs supporting low-income individuals. see macstats: medicaid and chip data book, medicaid & chip payment & access comm’n. 37-74 (dec. 2022), https://www.macpac.gov/wp-content/uploads/2022/12/macstats_dec2022_web-508.pdf [https://perma.cc/q7pv-fwp6]. 38. 42 u.s.c. §§ 1396 et seq. 39. for an in-depth discussion of the causes of income inequality in the twentieth century, see robert d. plotnick et al., the twentieth century record of inequality and poverty in the united states, inst. for rsch. on poverty (1998), https://www.irp.wisc.edu/publications/ dps/pdfs/dp116698.pdf [https://perma.cc/xm5n-wr6g]. 40. 42 u.s.c. §1396d(a)(31)(a) (barring medicaid funds from covering healthcare services for, “any individual who is an inmate of a public institution). 41. 42 u.s.c. §1396d(a)(31)(b) (barring medicaid funds from covering, “care or services for any individual who has not attained sixty-five years of age and who is a patient in an institution for mental diseases”). 42. see e. fuller torrey, american psychosis: how the federal government destroyed the mental health treatment system 44-45 (2014) (hereinafter american psychosis); see zelizer, supra note 2, at 181. https://perma.cc/xm5n-wr6g https://www.irp.wisc.edu/publications https://perma.cc/q7pv-fwp6 https://www.macpac.gov/wp-content/uploads/2022/12/macstats_dec2022_web-508.pdf indiana health law review [vol. 21:227 234 accurately, of not being places for efficacious medical treatment. 43 exposés on the abhorrent conditions within some individual psychiatric institutions throughout the twentieth century contributed to a movement towards deinstitutionalization. 44 the noble intentions of that movement likely contributed to the creation of the imd exclusion, or at least to the acceptance of the exclusion by the psychiatric community, members of congress, and the general public. 45 its results have been far from beneficial for people with smi. a. impact of the imd exclusion the imd exclusion bars federal fund participation (ffp) from reimbursing treatment in a facility that specializes in inpatient psychiatric care and has more than sixteen beds. 46 the effect of federal funds flowing towards every other type of healthcare services but not to psychiatric care has been a devastating reduction in the number of available psychiatric beds. 47 available psychiatric beds, particularly in state hospitals, have declined gradually but dramatically over the last sixty years. 48 fewer psychiatric beds means less access to mental healthcare for people who have the most serious mental health conditions. some common smi symptoms necessitate inpatient care far more than other, less severe mental health conditions. people with smi live under the constant specter of experiencing psychosis, the condition that leaves a person out of touch with reality and believing that ————————————————————————————— 43. see american psychosis, supra note 41, at 61-92; sabah h. muhammad & j. michael e. gray, an untenable space: the dilemma of black families caring for a loved one with severe mental illness and an argument for a legislative solution, 53 tex. tech l. rev. 575, 57781 (2021). 44. see american psychosis, supra note 41, at 44-45; community mental health act of 1963, pub. l. no. 88-164, 77 stat. 282 (1963) (codified as amended in 42 u.s.c. §§ 26612698(b)) (the movement reached its legislative apex with the last major legislation signed by president kennedy before his death). 45. it is worth noting that the imd exclusion received negligible attention from congress, the johnson administration, and the public at the time of its passage. in fact, medicare completely overshadowed medicaid at that time. considering the impact medicaid has had on the federal budget and the treatment of mental illness, it is shocking how little discussion occurred in 1965. see american psychosis, supra note 41, at 72-73 (citing interviews and testimony of individuals who worked on the social security amendments). 46. see 42 u.s.c. § 1396d(a)(31)(b) (text of the imd exclusion); see also 42 u.s.c. § 1396d(i) (defining imds as, “a hospital, nursing facility, or other institution of more than 16 beds, that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases, including medical attention, nursing care, and related services.”). 47. see generally doris a. fuller et al., going, going, gone, treatment advoc. ctr. 1-5 (june 2016), https://www.treatmentadvocacycenter.org/reports_publications/going-going-gonetrends-and-consequences-of-eliminating-state-psychiatric-beds/ [https://perma.cc/8egq-5m rz].. 48. id. https://perma.cc/8egq-5m https://www.treatmentadvocacycenter.org/reports_publications/going-going-gone 2024] codified disparity 235 irrational and objectively untrue delusions are authentic. 49 smi is generally treatable through medication and other services, but each case is unique, and some people experience smi that is treatment resistant. 50 smi is not like other less debilitating forms of mental illness in that it, almost without exception, completely disrupts the life of the person with the diagnosis and can be extremely difficult to treat for long periods of time. 51 the imd exclusion keeps those who require periodic inpatient psychiatric care from accessing it. in some states, that means they can access a hospital bed for limited amounts of time. 52 in other states, it is nearly impossible for them to access inpatient psychiatric care at all. ————————————————————————————— 49. see nat’l inst. mental health, u.s. dep’t health & hum. serv., pub. no. 20-mh810, understanding psychosis 1-3 (dec. 2019), https://www.nimh.nih.gov/sites/default/files/ documents/health/publications/understanding-psychosis/understanding-psychosis.pdf [https:// perma.cc/y4qf-sr5q]. 50. see e. fuller torrey, surviving schizophrenia: a family manual 100 (7th ed. 2019) (hereinafter surviving schizophrenia). 51. see id. at 70-83 (quoting justice ginsburg “placement outside the institution may never be appropriate,” and acknowledging the severity of some mental health cases); see also olmstead v. l. c. by zimring, 527 u.s. 581, 605 (1999) (citing brief for american psychiatric association et al. as amicus curiae supporting respondents, olmstead v. l. c. by zimring, 527 u.s. 58 (1999), 1999 wl 134004). 52. states have two options for accessing ffp for inpatient smi treatment in imds and both are limited in scope. the first is a 2016 rule that allows one stay of up to fifteen days within a monthly payment period. see special contract provisions related to payment, 42 c.f.r. § 438.6(e) (2020), https://www.govinfo.gov/content/pkg/cfr-2023-title42-vol4/pdf/cfr-2023title42-vol4-sec438-6.pdf . the other is via sec. 1115 of the social security act, through which states may apply for demonstration waivers. see 42 u.s.c. § 1315a. through a “demonstration project,” cms has the authority to waive specific provisions of medicaid law. id. at § 1315a(d). as the name implies, the waivers are an opportunity for states to demonstrate an alternative way to provide services to medicaid enrollees that is more efficient and/or furthers the legislative intent of the enabling legislation. this process is not generally an organic one, in which states may envision a new method of reimbursing for services and apply to cms. rather, it is a top-down process, in which cms creates waiver opportunities and then notifies state medicaid departments. see e.g. letter from daniel tsai, deputy adm’r & dir., ctr. for medicare & medicaid serv., to state medicaid dir. (apr. 17, 2023), https://www.medicaid.gov/sites/default/files/202304/smd23003.pdf. cms began accepting applications to partially waive the imd exclusion with respect to substance use disorder (sud) in 2015 and with respect to smi in 2018. see letter from vikki wachino, deputy dir., ctr. for medicare & medicaid ser., to state medicaid dir. (july 27, 2015), https://www.medicaid.gov/federal-policy-guidance/downloads/smd15003.pdf (announcing sud waiver opportunity); see also letter from mary c. mayhew, deputy adm’r & dir., ctr. for medicare & medicaid ser., to state medicaid dir. (nov. 13, 2018), https://www.medicaid.gov/federal-policy-guidance/downloads/smd18011.pdf (announcing smi waiver opportunity). sec. 1115 smi demonstration waivers allow individual stays in an imd of up to sixty days so long as the statewide average length of stay does not exceed thirty days. the fifteen-day rule dates from 2016 and the first states to obtain waivers did so beginning in 2019. both provisions are better than having no method of accessing ffp but they both ignore the needs of people with chronic conditions like smi who sometimes need longer hospital stays. the fifteenday rule is only available to states with medicaid managed care, and most states do. see infra section iii c. however, the waivers require significantly more effort from state medicaid departments and only ten states and the district of columbia have taken advantage of the smi opportunity as of december 1, 2023. https://www.medicaid.gov/federal-policy-guidance/downloads/smd18011.pdf https://www.medicaid.gov/federal-policy-guidance/downloads/smd15003.pdf https://www.medicaid.gov/sites/default/files/2023 https://www.govinfo.gov/content/pkg/cfr-2023-title42-vol4/pdf/cfr-2023 https://www.nimh.nih.gov/sites/default/files indiana health law review [vol. 21:227 236 the lack of access to inpatient beds is not just about acute care and stabilizing the symptoms of a person with smi; it is also about achieving long term stability in the life of that person. smi advocates, the individuals and organizations who seek better access to care for people living with smi, describe a “revolving door”—the endless cycle from hospital, to incarceration, experiencing homelessness, and back again. smi advocates also advocate for a “continuum of care,” meaning “a variety of services including but limited to inpatient psychiatric facilities, outpatient services, housing support, integration of behavioral health and criminal justice solutions, and other services.”53 quality inpatient services are the cornerstone of that continuum and, although part of the revolving door cycle, inpatient care is also necessary to ending that cycle and achieving long term stability. 54 when a person is experiencing psychosis and lacks insight into their own condition, 55 inpatient psychiatric treatment can be medically necessary and is the most likely way to prevent them from further deterioration.56 denying a person that treatment is not a furtherance of the deinstitutionalization movement; it is an inhumane insistence that they languish on the streets, in jails, and in prisons because they could not access a treatment bed when they needed it. b. inherent discrimination of the imd exclusion the imd exclusion’s denial of inpatient psychiatric services to people with smi is not only ethically unconscionable but also unconstitutional. people with smi are a quasi-suspect class and are entitled to intermediate scrutiny under the fourteenth amendment’s equal protection clause. 57 ————————————————————————————— 53. see j. michael e. gray, hipaa, telehealth, and the treatment of mental illness in a post-covid world, 46 okla. city u. l. rev. 1, at note 43 (2021); accord debra a. pinals & doris a. fuller, beyond beds: the vital role of a full continuum of psychiatric care, treatment advoc. ctr. 3 (oct. 2017). 54. see generally pinals & fuller, supra note 52. 55. see american psychosis, supra note 41, at 95. 56. psychiatric deterioration is a term used in the statutory language of twenty-five states to describe the impact of smi on a person’s brain functioning. psychiatric deterioration is a form of harm to self that can be prevented through medical treatment in an appropriate facility. there are both physical manifestations in the brain matter and behavioral symptoms of a patient that result from lack of treating smi. see dailey et al., grading the states: an analysis of u.s. psychiatric treatment laws, treatment advoc. ctr. 18-20 (sept. 2020). the latest state to include psychiatric deterioration as a criterion for inpatient commitment is louisiana, and that state defines it as, “a decline in mental functioning, which diminishes the person’s capacity to reason or exercise judgment.” la. stat. ann. § 28:2(28) (2022). 57. the relevant text of the fourteenth amendment reads: no state shall make or enforce any law which shall abridge the privileges or immunities of citizens of the united states; nor shall any state deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws. u.s. const. amend. xiv, § 1 (emphasis added). 2024] codified disparity 237 the federal courts apply intermediate scrutiny, also known as heightened scrutiny, to determine whether a legal provision unconstitutionally discriminates against a class of quasi-suspect individuals. once the court determines that individuals fall within a quasi-suspect class, then it examines the nature of a policy that discriminates against the members of that class to see if it can identify a state interest. if the discriminatory act has such a government interest, then it may pass the intermediate scrutiny test and the discrimination may persist. 58 people with smi constitute a quasi-suspect class by passing jurisprudential muster of 1) being subjected to “a history of purposeful unequal treatment;” 59 2) possessing a characteristic that “bears no relation to ability to perform or contribute to society;” 60 are a “discrete group;” 61 and have been “relegated to such a position of political powerlessness as to command extraordinary protection from the majoritarian political process.” 62 people living with smi experienced purposeful unequal treatment prior to ————————————————————————————— courts apply either strict scrutiny, intermediate (also known as heightened) scrutiny, or rational basis to determine if a public law or program violates the equal protection clause. for a full analysis of equal protection clause violation with relation to mental illness, see gray & easdale, supra note 12, at 182-6. 58. see e.g., wengler v. druggists mutual ins. co., 446 u.s. 142 (1980). wengler was part of a late-twentieth century slew of cases that came to define the middle tier of judicial discrimination analysis. see also craig v. boren, 429 u.s. 190 (1976); califano v. goldfarb, 430 u.s. 199 (1976); califano v. westcott, 443 u.s. 76 (1979). these cases leading up to wengler synthesized rules related to scrutiny in questions of gender discrimination. the concept of intermediate scrutiny in this context has both troubled and confounded this article’s author since his first year of law school. the idea that classes of individuals may face discrimination if there is a government interest in oppressing them seems counterintuitive to the nature of twentieth century and contemporary movements towards equality, even if it is consistent with most of american history. a human-made legal framework justifying the unequal treatment of classes of people who have not been adjudicated as wrongdoers encapsulates the nation’s pre-civil rights era institutionalized bigotry more than it achieves equality or equity. 59. see massachusetts bd. of retirement v. murgia, 427 u.s. 307, 312-13 (1976) (summarizing and reapplying the element of historical purposeful unequal treatment. “[e]qual protection analysis requires strict scrutiny of a legislative classification only when the classification impermissibly interferes with the exercise of a fundamental right or operates to the peculiar disadvantage of a suspect class”). 60. city of cleburne v. cleburne living ctr., 473 u.s. 432, 440-41 (1985) (quoting frontiero v. richardson, 411 u.s. 677, 686 (1973)). frontiero involved gender and historical discrimination, which is a different subject matter from mental illness, but the court’s analytical framework is still useful here. 61. see united states v. carolene products co., 304 u. s. 144, 152-153, n.4 (1938) (origin of the terminology, considering an alleged violation of the fifth amendment’s interstate commerce clause); massachusetts board of retirement v. murgia, 427 u. s. 307, 313-14 (1976) (application of the term to a fourteenth amendment’s equal protection clause regarding age discrimination); brown v. gilliard, 483 u.s. 587, 602 (1987). brown is another fifth amendment challenge but has a related and useful line of reasoning. see also lyng v. castillo, 477 u.s. 635, 638 (1986). carolene products co., 304 u.s. at 153, n. 4. in the case of codified discrimination due to mental illness, the level of injustice does indeed call for a more searching inquiry. 62. san antonio indep. sch. dist. v. rodriguez, 411 u.s. 1, 30 (1973). indiana health law review [vol. 21:227 238 1965, and the imd exclusion only exacerbates their unjustly unequal place in american society. they also “contribute to society” in countless ways. 63 the frontiero court discussed “immutable characteristic[s] determined solely by the accident of birth” and the constitutionality of allowing discrimination based on such characteristics. 64 the cleburne court then analyzed the involuntary nature of some conditions, i.e., frontiero’s “accident of birth,” and whether they bear any relationship to one’s ability to contribute to society. 65 the status of living with mental illness is an “accident of birth,” or more accurately, the result of many factors outside the control of a person living with the condition, and does not bar them from having a positive impact on society. 66 for the question of whether a number of people constitute a discrete group, several cases apply some version of the phrase “discrete and insular” and then ask whether being such a minority group creates a “special condition” hampering the political processes which should be protecting a class of people.67 in lyng, justice stevens considered whether members of a “disadvantaged class” have been “subjected to discrimination,” have “exhibit[ed] obvious, immutable, or distinguishing characteristics that define them as a discrete group,” and are a “minority or politically powerless.”68 in several other cases examining this issue, courts asked if people who are different from the majority in some way have been subjected to injustices by state or federal law and if that discrimination, in the phrasing of the court in carolene products co., “may call for a correspondingly more searching judicial inquiry.”69 in the case of codified discrimination due to mental illness, the level of injustice does indeed call for a more searching inquiry. the last criterion, concerning political powerlessness, has some overlap with the question of discrete and insular groups. the political powerlessness of people with smi is due in large part to the lack of available treatment to get patients stable enough to take part in the political system. while it is not impossible for a person who is experiencing homelessness due to mental illness, for example, to be informed and vote in public elections, it is more difficult for them to do so than someone who is not living with those symptoms and in those conditions. furthermore, political power is much more than voting. the more ————————————————————————————— 63. see gray & easdale, supra note 12. 64. frontiero 411 u.s. at 686. 65. city of cleburne, 473 u.s. at 441-42. 66. see e.g., radhika chalasani, famous people living with bipolar disorder (april 11, 2018, 9:37am), https://www.cbsnews.com/pictures/famous-people-celebrities-bipolar/ (discussing a few of the many people living with bipolar disorder who have found success in the entertainment industry). 67. carolene products co., 304 u. s. 144, 152-53 n.4; massachusetts board of retirement v. murgia, 427 u. s. 307, 313-14 (1976) (application of the term to a fourteenth amendment’s equal protection clause regarding age discrimination); brown v. gilliard, 483 u.s. 587, 602 (1987). brown is another fifth amendment challenge but has a related and useful line of reasoning. see also lyng v. castillo, 477 u.s. 635, 638 (1986). 68. lyng, 477 u.s. at 638. 69. carolene products co., 304 u.s. at 153 n.4. https://www.cbsnews.com/pictures/famous-people-celebrities-bipolar 2024] codified disparity 239 nuanced aspects of influencing political systems require levels of experience, knowledge, social status, financial resources, and other attributes that are difficult for people with untreated smi to possess. people living with smi meet all criteria as a quasi-suspect class, and as members of a constitutionally protected class, there is no government interest in discriminating against them by denying them the same level of care as people without smi. 70 treating different classes of people unequally under the law is the anthesis of the equal protection clause. treating one group of people differently than others on the basis of a psychiatric condition violates yet another framework for equity—mental health parity. iii. parity: congressional intent to bring about healthcare justice for people with mental health conditions mental health parity means equal coverage or equal restrictions to coverage for both behavioral health—e.g., mental illness, intellectual disabilities, and substance use disorder treatment—and medical/surgical coverage, i.e., everything that is not behavioral health. 71 several pieces of state and federal law govern mental health parity in the united states and congressional intent on the topic is clearest in the rehabilitation act of 1973, the americans with disabilities act (ada), 72 and the mental health parity and addiction equity act of 2008 (mhpaea). 73 those three statutes, in chronological order, represent a progression towards undoing past acts of congress that impose inequality on healthcare services and other public programs. a. rehabilitation act of 1973 section 504 of the rehabilitation act of 197374 was the first post-imd exclusion indication that congress no longer wanted to single out people with disabilities like smi and deny them the benefits of federally funded programs that people without disabilities may receive. section 504 was the first step in a five-decade arc towards recognition that federal law systematically discriminates against some classes of people: “no otherwise qualified individual ————————————————————————————— 70. unless, of course, the government wants to oppress them. this is unlikely considering evolving congressional desire to protect and provide treatment for people with smi. see infra sections iii & iv. but little scholarship exists addressing the question of whether the legislative and executive branches of federal and state governments have a nefarious but calculated interest in refusing the upward mobility of people living with mental illness. 71. see generally what is parity? the kennedy forum, https://www.thekennedyforum.org/ parity/ [https://perma.cc/ds5z-nyt5] (last visited feb. 19, 2024). 72. americans with disabilities act of 1990 (ada), 42 u.s.c. §§ 12101-12213 (2018). 73. paul wellstone and pete domenici mental health parity and addiction equity act of 2008, pub. l. no. 110-343, 122 stat. 3765 (2008). 74. rehabilitation act of 1973, pub. l. no. 93-112, 87 stat. 355 (1973) (codified as amended in sections of 29 u.s.c. §§ 701 et seq). https://perma.cc/ds5z-nyt5 https://www.thekennedyforum.org indiana health law review [vol. 21:227 240 with a disability in the united states . . . shall, solely by reason of her or his disability, be excluded from the participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal financial assistance.”75 a plain reading of section 504 in a vacuum would invalidate the imd exclusion; state medicaid programs are “receiving federal financial assistance” as a function of their existence. in fact, cms uses federal medicaid funds to reimburse healthcare providers for literal rehabilitation services, and mental illness is the leading cause of disability in the united states.76 but its intent and scope focused more on individualized plans for students with disabilities and some accommodations for adults. 77 its relevance to this article lies in the wink and nod that congress gave to the existence of federally sanctioned discrimination as well as the public push back when the federal department of health, education, and welfare (hew) did not enforce the law as written. hew had promulgated no regulations to enforce section 504 four years after its passage. the american coalition of citizens with disabilities (accd) organized a sit-in of hew’s headquarters in washington, dc to vent frustration and draw attention to the lack of follow-through by the federal government. 78 the dc protest generated public support for people with disabilities and lead to many more demonstrations around the country. the most visible and effective of the ensuing demonstrations was arguably an occupation of a hew building in san francisco that lasted twenty-five days.79 attention garnered by disability rights activists undoubtedly got the attention of both the white house 80 and congress, but federal policy shifts happen slowly, and it was another thirteen years before either acted to address federal discrimination against people with disabilities in any meaningful way. b. americans with disabilities act of 1990 congress passed the ada in 1990 as the legislative apex of an advocacy effort, stretching at least from the time prior to section 504 in the early 1970s, to extend civil rights protections and guarantee accommodations for people with ————————————————————————————— 75. 29 u.s.c. § 794(a). this is the language of sec. 504 from the enabling legislation. 76. mental health awareness, cdc (january 20, 2011), https://archive.cdc.gov/#/ details?q=mental%20health%20awareness&start=0&rows=10&url=https://www.cdc.gov/geno mics/resources/diseases/mental.htm. 77. see doris zames fleischer, the disability rights movement: from charity to confrontation 49-70 (2001). 78. see id. at 53-55. 79. see id. at 29, 53-55. 80. president richard nixon vetoed the first two attempts at the legislation, then finally gave in on the third bill that passed congress. see e.g., richard m. nixon, veto of the vocational rehabilitation bill, the am. presidency project (march 27, 1973), https://www.presidency. ucsb.edu/documents/veto-the-vocational-rehabilitation-bill (nixon’s message on the veto of one of the two bills; the other was a pocket veto, meaning he allowed the bill to expire without his signature). https://ucsb.edu/documents/veto-the-vocational-rehabilitation-bill https://www.presidency https://details?q=mental%20health%20awareness&start=0&rows=10&url=https://www.cdc.gov/geno https://archive.cdc.gov 2024] codified disparity 241 disabilities. this group, in the words of the 101st congress, constitutes: [a] discrete and insular minority who have been faced with restrictions and limitations, subjected to a history of purposeful unequal treatment, and relegated to a position of powerlessness in our society, based on characteristics that are beyond the control of such individuals and resulting from stereotypic assumptions not truly indicative of the individual ability of such individuals to participate in, and contribute to, society. 81 the ada specifically included mental health conditions alongside physical disabilities as conditions in need of federal protection against discrimination. 82 subsequent regulations authorized by the ada and the ada amendments of 2008 further specify the severe mental illnesses of schizophrenia, bipolar disorder, and major depressive disorder all have the ada’s protections. 83 the ada requires all public entities to avoid providing services in a way that discriminates on the basis of a disability. 84 since state medicaid departments are public entities and smi is a disability under the ada, failing to provide healthcare services equally for smi patients and medicaid enrollees without smi has the practical effect of denying them accommodations for their disabilities. if one medicaid enrollee has a physical ailment, such as a broken leg, medicaid will cover the entire spectrum of care that is medically necessary, from diagnosis and testing to hospital admission, through discharge and physical therapy. however, if another medicaid enrollee has a mental health diagnosis, such as schizophrenia, medicaid will only cover part of the continuum of care for the patient and will not usually provide the inpatient care adequate for stabilization.85 it is the equivalent of denying the patient with the broken leg inpatient services needed to surgically reconstruct their leg but offering outpatient services that will never allow them to regain function and walk. as ————————————————————————————— 81. originally codified as 42 u.s.c. § 12101(a)(7), the 110th congress subsequently deleted that paragraph but did nothing to counteract its intent or effect. the paragraph is still relied upon by the federal judiciary in valid case law, e.g., martin v. voinovich, 840 f. supp. 1175, 1209 (s.d. ohio 1993). 82. see e.g., 42 u.s.c. § 12101(a)(1). 83. see 29 c.f.r. § 1630.2(j)(3)(iii) (2011) (“[i]t should easily be concluded that the following types of impairments will, at a minimum, substantially limit the major life activities indicated . . . [including, inter alia] major depressive disorder, bipolar disorder, post-traumatic stress disorder, obsessive compulsive disorder, and schizophrenia.”). by implication, this definition also includes schizoaffective disorder. schizoaffective disorder is a condition in which an individual experiences the major “mood episode” symptoms of bipolar disorder and the delusions or hallucinations of schizophrenia. see dolores malaspina et al., schizoaffective disorder in the dsm-5, 150 schizophrenia rsch. 21 (2013). (defining and discussing schizoaffective disorder). 84. see 28 c.f.r. § 35.130(b)(3) (2016). 85. this is both the very nature and the real-world effect of the imd exclusion. indiana health law review [vol. 21:227 242 absurd as that would be, it is what happens to smi patients denied medically necessary medicaid benefits by the state because of federal law. 86 the effect of the imd exclusion is to discriminate on the basis of disability, the exact behavior by a public entity that congress intended to end with the ada. c. mental health parity and addiction equity act of 2008 decades of advocacy for congressional action on parity resulted in the mhpaea. senators paul wellstone and pete domenici led a bipartisan effort for legislation to hold health insurance plans accountable and force them to treat mental health conditions and physical conditions equitably. 87 despite several earlier attempts, 88 mhpaea passed into law as a rider on a funding bill in late 2008 and required, inter alia, parity in deductibles and copayments, amount of coverage (e.g., doctor visits or length of stay), parity in out-of-network care, and disclosure to those covered under a health plan of any medical reasons for denial of benefits. 89 it was a clear statement of congressional intent to disallow discrimination by health plans in the form of coverage disparity. 90 although congress specifically carved out medicaid and medicare from mhpaea, most states administer medicaid via contracts with private entities ————————————————————————————— 86. medicaid is administered at the ground level by states but governed in large part by federal law. see 28 c.f.r. § 35.130(b)(3) (2016). 87. sen. ted kennedy and his son rep. patrick kennedy were also heavily involved in the formulation and passage of mhpaea. for a brief general history of the legislation, see medicaid and children’s health insurance programs; mental health parity and addiction equity act of 2008; the application of mental health parity requirements to coverage offered by medicaid managed care organizations, the children’s health insurance program (chip), and alternative benefit plans, 81 fed. reg. 18390, 18391 (march 30, 2016). 88. mental health advocates and their allies in congress made a hard push for parity legislation in the mid-1990s. they succeeded in passing the mental health parity act of 1996 (mhpa). pub. l. no. 104-204, 110 stat. 2874 (1996). mhpa began with lofty goals but passed as a gesture to the mental health advocacy community. senators wellstone and domenici attempted to amend the health insurance portability and accountability act (hipaa) with farreaching parity language, but they were thwarted, in part, by a hefty price tag for their legislation. see c.b.o. rep. may 13, 1996, https://www.cbo.gov/sites/default/files/104th-congress-19951996/reports/1996_05_13_parity.pdf [https://perma.cc/5w8x-spyx ] (projecting a 4 percent increase in the employers’ share of private health plans). mhpa required group health plans that offered mental health coverage to apply the same annual limits for that coverage as for medical/surgical benefits. for a discussion of the history of mental health parity legislation, including mhpa, see colleen l. barray et al., a political history of federal mental health and addiction parity, 88 milbank q. 404 (2010). 89. pub. l. no. 110-343, 122 stat. 3765 (2008).. 90. the term “equity” in this context should not be confused with “equality.” mhpaea is about both, but equality means access to mental healthcare on an equal footing with primary healthcare. equity, however, is about the appropriateness of that care. for a patient with smi, access to psychiatric care may be useless unless qualified mental health providers treating the patient have expertise in the exact diagnosis and symptoms the patient exhibits. for a brief discussion of equality versus equity, see “how are equity and equality different?” just health action (2010), http://justhealthaction.org/wp-content/uploads/2010/05/jha-lesson-plan-3how-are-equity-and-equality-different-final.pdf [https://perma.cc/8d6m-e8jz]. https://perma.cc/8d6m-e8jz http://justhealthaction.org/wp-content/uploads/2010/05/jha-lesson-plan-3 https://perma.cc/5w8x-spyx https://www.cbo.gov/sites/default/files/104th-congress-1995 2024] codified disparity 243 that manage the delivery of services for medicaid enrollees. these entities, known as managed care organizations (mcos), 91 are subject to parity provisions under mhpaea. 92 the federal centers for medicare and medicaid services (cms) promulgated a rule in 2016 addressing this issue. 93 cms clarified which provisions of mhpaea apply to mcos, 94 but the agency performed some deliberate mental gymnastics in explaining why mhpaea does not apply to the imd exclusion.95 while frustrating for advocates and members of congress who see the imd exclusion as stark disparity in coverage, it is not cms’ fault that it failed to apply mhpaea to the exclusion through the regulatory process. cms was faced with two statutes of conflicting purpose, and it is not the role of an executive branch agency to compare two eras of american political history and determine if congress has shifted its position implicitly through statutory interpretation. that is, however, one of the roles of the federal judiciary. iv. the imd exclusion as mental health disparity: the subjectivity of generality mhpaea, the ada, and the rehabilitation act render the imd exclusion unenforceable because all four apply to mental illness treatment, but the imd is broad compared to those subsequent legislative acts that contemplated mental healthcare and more specifically addressed disparity. an act of congress that expresses explicit intent towards a specific goal supersedes a more general legislative act. 96 the rehabilitation act, ada, and mhpaea represent an evolution of congressional intent towards equality and equity between psychiatric care and other medical treatment. the imd exclusion affected discrimination against people with smi, but it was written both hastily and broadly, with varying implications for several groups of people. people living with smi have taken the brunt of the imd exclusion’s discriminatory outcomes, but people living with less severe (although still serious) mental illnesses, substance use disorder, personality disorders, some juveniles living with severe emotional disturbances, and others are also victims of one small paragraph ————————————————————————————— 91. thirty-nine states and the district of columbia contract with medicaid mcos. see total medicaid mcos, kaiser family foundation, https://www.kff.org/medicaid/state-indicator/ total-medicaidmcos/?currenttimeframe=0&sortmodel=%7b%22colid%22:%22location%22,% 22sort%22:%22asc%22%7d [https://perma.cc/2hz9-pyb8]. 92. see medicaid and children’s health insurance programs supra note 86. 93. see id. 94. see id. 95. see id. at 18423. the regulation is shortsighted; it points out that, “the full range of covered services, including mh/sud services, could be provided to beneficiaries when they are in facilities that are not imds,” completely ignoring the highly specialized nature of psychiatry within the medical field. imds are staffed by doctors, nurses, and other staff who understand smi and how to treat it in ways that general hospitals usually cannot. 96. see e.g., dobbins v. terrazzo machine & supply co., 479 s.w.2d 806 (tenn. 1972) (explaining the tendency of the court to apply specific statutory provisions over competing general language). https://perma.cc/2hz9-pyb8 https://www.kff.org/medicaid/state-indicator indiana health law review [vol. 21:227 244 enacted nearly six decades ago. in the wake of that prejudicial paragraph, attitudes towards inpatient psychiatric treatment in the united states have changed, and congress has changed along with its constituents. the specific aim of mhpaea to ensure mental health parity in the ways that health plans reimburse healthcare providers is the strongest and most recent indication that the imd exclusion cannot withstand an analysis of congressional intent. 97 a tenet of judicial statutory interpretation is that specific legislation regarding a given subject matter is paramount to general legislation on the same topic. 98 when a legislature presents the judiciary with two contradictory pieces of legislation, “a statute treating the subject in a general manner should not be considered as intended to effect the more particular provision.”99 this common law principle is somewhat idealistic in its presupposition that legislative bodies are aware of the precedents they set and the existing law they supersede each time they pass a bill. it gives legislatures the (possibly unwitting) power to put courts in the position of having to decide what is general and what is “more particular.” legislative bodies generally lack the intentional insight into antecedents that are inherent in judicial review. the influence of electoral politics on legislative processes leads to outcomes that are not always tailored with an eye towards judicial scrutiny. among the most illustrative examples is the patriot act, which passed a mere forty-five days after its introduction and faced a plethora of legal challenges. 100 some bills with more robust history and more regard towards the wellbeing of the people affected by them can still have provisions that are crafted and passed so hastily they do not contemplate the generality or specificity of legislation if it runs afoul of an earlier statute. the very legislation that gave rise to the rule of general versus specific legislative language, woodruff v. city of nashville, determined a question of an attorney’s avenue for challenging a disbarment proceeding. 101 it is doubtful that the court contemplated a matter as nuanced as the history of mental health treatment legislation and the more recent move towards parity. the social security amendments of 1965 were not a hasty reaction to a horrible act of foreign terrorism like the patriot act nor a strictly procedural law like the state code interpreted by the woodruff court, but the imd exclusion was still conceived, drafted, heard in committees and both chambers’ floors, and passed at lightning ————————————————————————————— 97. see 153 cong. rec. s1864-5 (daily ed. feb. 12, 2007) (statement of rep. patrick kennedy regarding the intent of mhpaea). 98. see dobbins, 479 s.w.2d at 809. 99. id. (quoting woodroof v. city of nashville, 192 s.w.2d 1013). 100. usa patriot act of 2001, pub. l. no. 107-56, 115 stat. 272 (2001). for one of the earlier, and arguably avoidable, challenges to the patriot act, see e.g., doe v. ashcroft, 334 f.supp.2d 471 (s.d.n.y. 2004). this is one of the most famous instances of congress passing legislation so hastily that the legislature’s own internal failsafe mechanisms, like the office of the legislative counsel, did not have the necessary time to vet all aspects of legislation against potential judicial challenges. 101. woodruff, 192 s.w.2d at 86. 2024] codified disparity 245 speed by congressional standards; the principle from woodruff could still render it unenforceable as contraveningly vague. just as congress and state legislatures do not always take the time to appreciate the impact of their actions upon legal precedents, 102 its members take even less time to consider the practical future implications of legislative compromises necessitated by political realities at the time they are considering legislation. 103 medicare was the political and public policy goal of the social security amendments of 1965. medicaid was a larger version of an earlier compromise meant to keep medicare from ever passing the house of representatives. 104 to save more money in the ever-expanding great society social reforms, congress included the imd exclusion. 105 its intent was likely to save money at least as much if not more than to achieve any policy goals. subsequent legislation related to mental health accommodations and treatment—the rehabilitation act, the ada, and mhpaea—carried the weight of congress’ policy and contemplated consequences to people with mental illness. the 89th congress made no reference to specific smi conditions when it created the imd exclusion, 106 but congress did express intent regarding mental illness in the other three statutes discussed above. 107 the imd exclusion had both philosophical and financial underpinnings and has had both unethical and financial consequences, 108 but it very likely survived the legislative process and made its way into the final version of the social security amendments of 1965 ————————————————————————————— 102. or even, at times, governing law like the united states constitution. 103. one of the most glaring examples of well-intended legislation leading to unintended consequences is related to the topics discussed in this article. the community mental health act of 1963, supra note 43, had the laudable goal of moving people who could thrive with only community-based outpatient treatment away from psychiatric institutions and back into their communities. however, federal support for outpatient care, likely envisioned by president kennedy, never materialized after his assassination. for an analysis of the transition from kennedy to johnson administrations and its policy implications regarding mental healthcare, see gray & easdale, supra note 12, at 167-71. 104. see zelizer, supra note 1. chairman mills dusted off an idea that had passed congress during president kennedy’s tenure, the kerr-mills act, and greatly expanded its scope as part of the social security amendments of 1965. 105. see supra, section i. 106. the closest thing to specificity in the imd exclusion is the term “institution for mental diseases.” see 42 u.s.c. §1396d(a)(31)(b). congress later defined imds but did not specify categories of “mental diseases” barred from coverage. see 42 u.s.c. § 1396d(i). cms has interpreted the exclusion broadly, meaning anyone with smi, e.g., schizophrenia, a serious mental illness like post-traumatic stress disorder, or substance use disorder. all those diagnoses, plus at least dozens more, fall under the wide umbrella of “mental diseases.” 107. see, e.g., 42 u.s.c. § 12101(a)(1) (mental health in the context of ada); mental health context in mhpaea is passim. 108. the ethical implications involve the lack of parity and blatant discrimination. regarding the financial toll of the imd exclusion, several members of congress have openly been seeking more data on the implications of repealing the exclusion. see departments of labor, health and human services, and education, and related agencies appropriations bill, 2023, 117th cong. 182 (2022). indiana health law review [vol. 21:227 246 as a cost saving device. 109 the 89th congress chose to single out two populations—those in need of psychiatric care and justice involved persons— and deemed them unworthy of an entitlement program. 110 subsequent landmark legislation represents a more humanitarian bent in the arc towards healthcare justice for the people who are compoundedly marginalized by both living in poverty and being in need of mental healthcare services. with the mhpaea, congress expressed intent to end the discrimination caused by denying mental healthcare parity and with an array of services for people with disabilities, including smi, under the ada and rehabilitation act. the imd exclusion fails the common law test of general versus “more particular” legislation in the face of those more recent bills. the newer laws are both more specific to the treatment of mental illness and show congress’ evolution towards supporting a continuum of care for people living with mental health conditions. v. conclusion if this article correctly assesses congress’ evolving attitude on protecting and providing services for people with smi, then why did congress not repeal the imd exclusion in 1973, 1990, or 2008? the most likely answer is not just a lack of compassion but also a lack of willingness to pay for it. in the middle part of the last decade, the congressional budget office (cbo) prepared a fiscal analysis of repealing the imd exclusion and estimated a cost of $40—$60 billion over the first ten years. 111 that is a significant amount of money, but it is also the cost of ending federally sanctioned discrimination and no longer turning a blind eye to mental health disparity. compared to the amount of overall federal spending—about $6.27 trillion in the 2022 fiscal year—it would be a small price to ensure better access to healthcare, thus alleviating the suffering of a vulnerable population. the fallout from a lack of inpatient services, 112 and the gap it leaves in the continuum of care, is driving cyclical homelessness, 113 incarceration, 114 suicide ————————————————————————————— 109. see supra, section i. 110. see 42 u.s.c. §1396d(a)(31) (2018). 111. c.b.o. rep. nov. 3, 2015, https://www.cbo.gov/sites/default/files/114th-congress2015-2016/costestimate/hr2646directspendingeffectsoftitlev.pdf. [https://perma.cc/x69p-8s m4]. 112. see generally american psychosis, supra note 41. 113. see fred e. markowitz, psychiatric hospital capacity, homelessness, and crime and arrest rates, 44 criminology 45 (2006). 114. see greg a. greenberg and robert a. rosenheck, jail incarceration, homelessness, and mental health: a national study, 59 psychiatric services 170 (2008). https://perma.cc/x69p-8s https://www.cbo.gov/sites/default/files/114th-congress 2024] codified disparity 247 and other causes of death, 115 and violence. 116 congress created this dystopian dichotomy within inpatient care—one group of people cannot access life-saving services while another can, based solely on the former having involuntary conditions. but the resources to counteract that disparity exist and the first steps are known by advocates and mental health providers. congress can authorize and fund those resources, starting with repeal of the imd exclusion. if congress continues to ignore the harm done by the imd exclusion, then the federal judiciary should question the validity of the exclusion given the shift of congressional intent towards protecting people with mental illness. allowing this discriminatory law to persist through the 2020s will set the tone for increased suffering among the most vulnerable americans for the duration of the twenty first century as the number of psychiatric inpatient beds continues to shrink with the number of specialized healthcare providers to deliver services. either the judicial branch, the legislative branch, or both should bring down barriers to mental healthcare and parity, starting with the imd exclusion. ————————————————————————————— 115. see mark olfson et al., premature mortality among adults with schizophrenia in the united states, 72 psychiatric services 1172 (2015) (a study of adult medicaid recipients with schizophrenia showed decreased life expectancy compared to the general public); carsten hjorthøj et al., years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis, 4 the lancet psychiatry 295 (2017) (survey of international studies showing decreased life expectancy in people with schizophrenia); jennifer boggs et al., general medical, mental health, and demographic risk factors associated with suicide by firearm compared with other means, 69 psychiatric services 677, 683 (2018) (recommending that a mental disorder diagnosis be taken into account when assessing an individual’s risk of dying by suicide). 116. see k.s. douglas et al., psychosis as a risk factor for violence to others: a metaanalysis, 135 psychological bulletin 679 (2009) (concluding that psychosis is associated leads to a 49%--68% increase in violence towards others). it is indisputable that psychosis sometimes causes acts of violence towards others, but people living with smi are more likely to the victims of violent acts than to commit them. see norman ghiasi et al., psychiatric illness and criminality, https://www.ncbi.nlm.nih.gov/books/nbk537064/#:~:text=people%20with%20mental%20illne ss%20are%20more%20likely%20to%20be%20a,compared%20to%20the%20general%20popula tion. [https://perma.cc/y6eb-6p6s]. furthermore, suicide is a form of violence, and untreated mental illness increases the risk of dying by suicide. see boggs et al. supra, note 115. https://perma.cc/y6eb-6p6s https://www.ncbi.nlm.nih.gov/books/nbk537064/#:~:text=people%20with%20mental%20illne structure bookmarks indiana health law review right-sizing inflation in anti-kickback law rhetoric: avoiding unnecessary market distortion in commissions on medical device sales right-sizing inflation in anti-kickback law rhetoric: avoiding unnecessary market distortion in commissions on medical device sales thomas n. bulleit∗ we, of course, recognize that many of these advertising and marketing activities do not warrant prosecution in part because (1) they are passive in nature, i.e., the activities do not involve direct contact with program beneficiaries, or (2) the individual or entity involved in these promotions is not involved in the delivery of health care. 1 “commissions are the payments prohibited by the anti–kickback statute and may be referred to at times as ‘kickbacks.’ there is no distinction . . . between a commission and a kickback.”2 ————————————————————————————— * mr. bulleit recently retired from an almost 40-year legal career that included three terms as chair of the d.c. bar health law section, and the last decade as head of the d.c. health care practice of ropes & gray, llp. in addition to extensive trade press writings, he has published in the st. mary’s journal of legal malpractice and ethics, the journal of health & life sciences law, the food & drug law journal, and developmental psychology. he is a cum laude graduate of yale college and received his j.d. from the university of michigan law school, where he was article and symposium editor of the journal of law reform and received the louis honigman award for greatest contribution to the journal, before clerking on the sixth circuit for the hon. bailey brown. mr. bulleit would like to thank emma coreno, a longsuffering associate at ropes & gray, for her assistance (and perseverance) in the preparation of this article. 1. medicare and state health care programs: fraud and abuse & oig anti-kickback provisions, 56 fed. reg. 35952, 35974 (july 29, 1991) (to be codified at 42 c.f.r. pt. 1001). 2. united states v. st. junius, 739 f.3d 193, 199 n.6 (5th cir. 2013). in this and all of the other judicial decisions revealed by our research that express a similar view of the statute, the statements are obiter dicta, not part of the holding. see also united states ex rel. nicholson v. medcom carolinas, inc., 42 f.4th 185, 194 (4th cir. 2022) (absent an exception or safe harbor “commissions earned by an independent contractor based on volume or value are illegal ‘remuneration’ under the statute . . . . [i]t would violate the anti-kickback statute . . . to pay a medical-device salesperson by commission per sale or based on the value of sales and get paid back in federal healthcare money.”); united states ex. rel. lutz v. mallory, 988 f.3d 730, 735 (4th cir. 2021) (“[t]he volume-based commissions paid by [defendant] to [consultant] and its sales contractors violated the anti-kickback statute because these commissions constituted ‘remuneration’ intended to induce sales representatives to sell as many tests as possible.”); united states v. george, 171 f. supp. 3d 810, 817 (n.d. ill. 2016) (citing with approval statement in “ultimate guide to home health marketing”: “it is common knowledge that providers cannot pay anyone for referring a patient for services, but this statute goes well beyond simply paying someone for a referral [and] prohibits any arrangement between a provider and another party where one purpose of the arrangement is to induce referrals.”), aff’d, 900 f.3d 405 (7th cir. 2018); united states v. brown, 871 f.3d 352, 354 (5th cir. 2017) (“federal law forbids commission payments for referrals, as they greatly increase the incentive for fraud (that is, for recruiting patients who do not need equipment).”); united states v. turner, 561 f. app’x 312 (5th cir. 2014) (finding that the defendant “recei[ved] kickbacks in the form of medicare referral commissions”); united states v. robinson, 505 f. app’x 388 (5th cir. 2013) (“the anti-kickback statute provided robinson with fair notice that the paying of fees and commissions . . . for medicare referrals was prohibited conduct.”); united states ex rel. silva v. vici mktg., llc, 361 f. supp. 3d 1245, 1254, 1256 (m.d. fla. 2019) (denying the defendant’s motion to dismiss because the defendant “knew that paying commissions per prescription to marketers regarding governmentindiana health law review [vol. 22:27 28 abstract for three decades, the federal agency charged with administrative oversight of the federal health care programs anti-kickback statute, the office of the inspector general of the department of health and human services, has advised that paying for marketing and advertising of covered health care items and services should be treated as “at most a technical violation” of the law. oig has noted that enforcement should be limited to cases where certain “suspect characteristics” are present and has issued several advisory opinions declining enforcement in the case of commission-type payments to independent sales agents. in contrast, in the last twenty years, obiter dicta in a number of judicial decisions upholding criminal convictions have described such commissions as a per se violation of the law. left unchallenged, this rhetorical inflation presents unjustified risks of enforcement to medical device makers for nothing more nefarious than selling their products in accordance with widespread industry norms that do not implicate any of the purposes underlying the anti-kickback statute. more important, these decisions have the potential to distort the health care economy through economically disadvantageous allocations of resources: the wastefulness of unwarranted enforcement on the one hand, and on the other, discouraging innovation by imposing additional costs on medical product makers, especially the often small, entrepreneurial, one-product companies that dominate the medical device industry, and do not have the resources to use a fully-employed sales force. this article attempts to remedy these risks by showing that, dicta in the opinions notwithstanding, the facts in those cases track the agency’s guidance, upholding convictions only when suspect characteristics—chiefly that the sales personnel are not truly independent sales representatives but are in a position to exercise undue influence over referral decisions—have been present. presenting an independent but parallel argument, the article also examines a recent supreme court case narrowing the meaning of the term “induce” in an analogous criminal statute, and shows how this new authority also (perhaps even more strongly) supports the conclusion that the anti-kickback law may not be used to prosecute ordinary commissions. in the hope that it also will influence courts and lead to a more fair, accurate and pragmatic anti-kickback law jurisprudence, the article concludes with an appendix containing recommendations for joint oig/department of justice guidance that aligns the rules for enforcement discretion with this reality, instructing the bringing, or joining, of enforcement cases only when the presence of suspect characteristics creates a genuine risk of the fraud and abuse ————————————————————————————— funded claims was illegal because of his research into anti-kickback statutes and his experience in the healthcare industry”). cf. people v. duz-mor diagnostic lab’y inc., 68 cal. app. 4th 654, 671 (1998) (similarly-worded medi-cal anti-kickback law “prohibits payment of a commission to someone who arranges, through marketing activities, for services to be furnished to medi-cal beneficiaries.”). 2025] right-sizing inflation 29 evils that the statute was designed to prohibit. table of contents i. introduction ii. background a. the fhcp anti-kickback statute b. legislative history: rostenkowski on “conventional chain of sale” . iii. oig interpretation of commission sale arrangements a. regulatory history: rostenkowski v. oig b. regulatory guidance 1: “technical violations” v. “requisite intent to induce” c. regulatory guidance 2: “suspect” factors and characteristics 1. oft-cited “suspect characteristics” 2. suspect characteristics based on the nature of the sales agent a. “undue influence” 3. suspect characteristics based on the nature of the audience a. targeted to the vulnerable b. contact with the vulnerable c. physicians and hcps 4. suspect characteristics based on the nature of the activity a. passive or non-coercive v. coercive 5. suspect characteristics based on the nature of the product a. direct billing of a fhcp by the seller for the item or service sold by the sales agent b. marketing of items or services that are separately reimbursable by a fhcp (e.g., items or services not bundled with other items or services covered by a drg payment), whether on the basis of charges or costs c. whether the item or service is one for which there is a likelihood of overutilization based on the historical experience of fhcps, reimbursement methodology, or other reason 6. application of “suspect characteristics” in advisory opinions a. the rule: no combination of suspect factors sufficient to warrant enforcement (i) nature of sales agent: commission to independent sales agent allowed (ii) nature of audience: contact with persons in a position to order the services or beneficiaries allowed indiana health law review [vol. 22:27 30 (1) direct contact with ordering persons insufficient for enforcement (2) direct contact with beneficiaries insufficient for enforcement (iii) nature of activity: passive advertising and non-coercive patient education allowed (iv) nature of the product: separately reimbursable service directly billed by the seller allowed (1) podiatrists redux (2) overutilization b. the exception: dmepos, no-charge loaner products, and unsafeguarded risks warrant enforcement iv. judicial interpretation a. the classic view: arranging for or recommending has to be done by a relevant decisionmaker b. variation: the recipient with “undue influence” 1. “[g]arden variety” undue influence: payments to doctors and buyer employees 2. further articulating the undue influence standard 3. undue influence absent: ordinary sales calls on providers 4. undue influence found a. pressuring the boss b. vulnerable audiences (i) patient recruiters (ii) deceitful offers of “free” dmepos and coercive marketing c. effective decisionmaker v. conclusion appendix i. introduction the language first quoted above represents the longtime policy of the office of the inspector general of the department of health and human services (“oig”) towards commission arrangements with independent contractors for the sale of medical devices used in the diagnosis or treatment of medicare and other federal health care program (“fhcp”) patients. 3 as reflected in the ————————————————————————————— 3. this article focuses on medical device makers because unlike in the pharmaceutical industry—which is dominated by large companies with extensive in-house r&d capabilities— medical device innovation and development takes place mostly in small, entrepreneurial, often 2025] right-sizing inflation 31 quoted preamble to the fhcp anti-kickback statute (“aks”)4 safe harbor regulations, oig has long held that while certain marketing and advertising arrangements may constitute “at least a technical violation” of the aks, they are often “innocuous” and merit aks enforcement in only a subset of cases involving particular “suspect characteristics.” 5 probably at least in partial reliance on this position, as further set forth in several oig advisory opinions issued over the years, commissioned sales agents have remained one of the main ways in which makers of medical devices market and sell their products.6 expressing a very different sentiment, the second quote comes from a 2013 federal appeals court decision upholding a criminal conviction for violations of the aks. the decision, whose commission=kickback conclusion is echoed in several others from the last two decades (detailed supra note 2), involved the ————————————————————————————— one-product companies. see, e.g., alan kahn, the dynamics of medical device innovation: an innovator's perspective, in 2 the changing economics of medical technology, 89, 90 (annetine c. gelijns & ethan a. halm eds., 1991)(“the development of new medical devices generally takes place in small, entrepreneurial companies. . . . a small company can bring a new product to market in a fraction of the time required by a large company. in the small company the innovator usually is also a key decision maker and can take risks based upon his first-hand knowledge of the technology and its applications.”). because of the nature of the industry, fullyemployed sales representatives are an expensive luxury that many innovators cannot afford. likely, in part, to remain competitive in hiring the best-qualified personnel, even larger device makers adhere to this industry norm. accordingly, throughout the u.s. medical device industry, sales representatives typically work off commission in promoting products to the health care providers who prescribe and use them in diagnosis or treatment (mostly physicians and nurse practitioners), and who purchase directly—chiefly hospitals and ambulatory surgery centers, but also doctors’ offices. they are either solo 1099 independent contractors, or employees of a sales agent entity that is a 1099 independent contractor, which the industry calls a “distributor,” although such entities do not take title, and usually are paid solely on commission. this article will use the term “sales agent” to refer to all of these: individual 1099 contractors, employees (or contractors) of 1099 “distributors,” and the “distributors” themselves. 4. social security act § 1128b(b) (codified at 42 u.s.c. § 1320a-7b(1)(b) (2010)). 5. see, e.g., medicare and state health care programs: fraud and abuse; oig antikickback provisions, 56 fed. reg. 35952, 35974 (jul. 19, 1991) (to be codified at 42 c.f.r. pt. 1001). cf. u.s. dep’t of health & hum. servs., off. of inspector gen., advisory op. no. 98-10 (aug. 31, 1998) (approving a low risk of fraud and abuse commission arrangement that “would technically fall within the prohibition of the anti-kickback statute if the requisite intent were present”). 6. another reason for the independent sales agent model may be that device reps develop an expertise in the medical use of the products in which they specialize, giving them “a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment.” quinn grundy et al., device representatives in hospitals: are commercial imperatives driving clinical decision-making?, 44 j. med. ethics 589, 589 (2018). it is “likely that these practices are global.” id. see also bonnie o’connor et al., salespeople in the surgical suite: relationships between surgeons and medical device representatives, 11 plos one 1, 8 (2016) (“medical device representatives (‘device reps’) have become an integral part of operating room personnel. . . . device reps earn as commission a percentage of every sale they make. the moment the sterile packaging is opened in the or—both items previously selected and those that may be enlisted on the spot during the surgery—the rep earns the commission.”). see also supra note 3. indiana health law review [vol. 22:27 32 sale of medical devices for which payment was made under medicare. 7 manufacturers of medical devices can only take notice and wonder which advice to follow. can oig’s longstanding approach—commissions to ordinary independent sales agents are generally okay, subject to avoiding the “suspect characteristics”—be relied upon? or are device makers and their commissioned sales agents at serious aks risk for nothing more than selling a product that is used in the treatment of a medicare patient? the courts’ inflated rhetoric in these cases (e.g., “[t]here is no distinction . . . between a commission and a kickback”), even in dicta, presents serious, and unwarranted, risks to medical device makers and, by extension, to a healthcare economy that has to account for increased costs that may result from the likely inducement of unnecessary enforcement and inefficient allocation of industry compliance resources . at the risk of “we told you so,” now-professor joan krause and i warned in an article twenty-five years ago that oig’s failure to issue guidance or otherwise address this issue more directly could led to a proliferation of aks cases in otherwise “innocuous” circumstances. 8 a rise in the number of criminal aks cases of this kind that have reached the federal courts of appeal in the last several years is a disturbing indicator. 9 fortunately, at least so far, the news is not all bad and lends itself to a solution that would not disrupt sensible enforcement practices. this article will show that although these dicta may lead to some cases being brought when they shouldn’t have been, the holdings in those cases actually align with oig’s historic guidance. that is, dicta aside, a close reading of the facts demonstrates that aks liability continues to be imposed not where the recipient of the commission is truly an independent sales agent, but instead where they are persons in a position to exercise “undue influence” on the patient or the health ————————————————————————————— 7. medicare payment for medical devices is generally indirect. except for durable medical equipment and certain prosthetic and orthotic devices (“dmepos”), and certain new technologies granted temporary passthroughs, payment for devices is deemed to be built into medicare’s rates of payment for the patient care services in which they are used. see, e.g., medicare payment advisory comm’n, report to the congress: medicare and the health care delivery system 208 (2017), available at https://www.medpac.gov/wp-content/uploads/import_data/ scrape_files/docs/default-source/reports/jun17_reporttocongress_sec.pdf. 8. thomas n. bulleit & joan h. krause, kickbacks, courtesies, or cost-effectiveness: application of the medicare antikickback law to the marketing and promotional practices of drug and medical device manufacturers, 54 food & drug l.j. 279, 323 (1999) (“there is perhaps no other area in which manufacturers currently face a greater potential for antikickback law liability than for commissions paid to independent sales agents . . . .”). see also 56 fed. reg. at 35954; supra note 1 (language cited). an associate at our then-law firm when this article was published, prof. krause has gone on to a distinguished career in legal academia, including much scholarship on health care “fraud and abuse” in general, and the aks in particular. see generally joan h krause, unc sch. l., https://law.unc.edu/people/joan-h-krause/ [https://perma.cc/ wr5x-q2w5] (last visited oct. 19, 2024). 9. see infra section iv.b. by the author’s count, there were only four reported federal court of appeals decisions dealing with commissions as criminal aks violations as of 2000, while since then there have been over thirty such cases. https://perma.cc https://law.unc.edu/people/joan-h-krause https://www.medpac.gov/wp-content/uploads/import_data 2025] right-sizing inflation 33 care provider making the decision to purchase or order. so new enforcement guidance should serve only to discourage unwarranted enforcement, and not lead to any wholesale revision of well-considered compliance measures. still, such guidance is appropriate to guard against unjustified cases being brought by over-aggressive false claims act (“fca”)10 qui tam relators or over-ambitious prosecutors. zooming out a bit further, oig should team with the department of justice to make clear that buyers and sellers of medical products should not be forced by inflated prosecutorial and judicial rhetoric to abandon non-abusive, economically efficient, and industry-normative business practices due to an unnecessary and misleading fear of compliance risk. accordingly, the article advocates deflating this at best misleading, and at worst harmful, rhetoric by making changes to enforcement guidelines and industry guidance to better reflect actual fraud and abuse risk to fhcps. following this introduction, part i and part ii of the article frame the discussion by providing an overview of the aks, especially the overlooked legislative history that indicates congress did not intend for ordinary sales agent commissions to be treated as kickbacks. part iii summarizes oig’s longstanding interpretation of the law as applied to sales commissions, showing that in both regulatory preambles and advisory opinions, oig consistently has declined to treat commissions as per se kickbacks, or otherwise meriting sanctions. in part iv, the article dissects judicial opinions in which the language of per se violation is used, demonstrating that the facts in those cases instead actually track oig’s guidance. part v concludes that because the courts’ rhetoric in their opinions often not only is inconsistent with oig’s interpretation and unnecessary to their own holdings, but it may create an undue and unfair risk to medical device makers who are merely following industry norms and selling their products on commission through legitimate, independent sales agents. oig and the u.s. department of justice (“doj”) should adopt internal enforcement guidelines, and issue additional external guidance, that would grant more express protection to sales commissions that involve nothing more than arm’s-length selling of medical devices. 11 an appendix presents a proposal for joint doj/oig enforcement guidelines that would incorporate the principles fairly reflected in oig’s guidance and in the reported judicial decisions. ————————————————————————————— 10. the false claims act, 31 u.s.c. §§ 3729–3733 (2021). 11. although the supreme court’s recent expunging of chevron deference from administrative procedure act jurisprudence might in some circumstances lead to an undoing of problematic hhs regulations, that pathway seems not available here. loper bright enterprises v. raimondo, 144 s. ct. 2244, 2273 (2024) (overruling chevron u.s.a. inc. v. natural resources defense council, inc., 467 u.s. 837 (1984)). as discussed infra notes 22–30 and accompanying text, although the agency may have departed from congressional intent in not protecting independent sales representative commissions in its initial safe harbor regulations, loper bright seems to provide only an avenue for undoing agency regulations, not compelling the promulgation of new ones. moreover, here the agency’s guidance is the more appropriate interpretation of the law. accordingly, absent the unlikelihood of statutory reform, joint agency guidance seems the best hope. indiana health law review [vol. 22:27 34 ii. background a. the fhcp anti-kickback statute the aks makes it unlawful for individuals or entities knowingly and willfully to offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under fhcps, such as medicare, medicaid, and the champus/tricare program for dependents of active-duty military personnel. as interpreted by federal regulators and the courts, the statute has broad application to a range of arrangements in which benefits are offered or received to induce the referral of fhcp business (including, in pertinent part, the order or purchase of medical devices used in the diagnosis or treatment of fhcp patients). simplifying numerous judicial decisions over the years, oig summarizes the principal purposes of the law as preventing (1) overutilization, (2) increased program costs, (3) corruption of medical judgment, (4) patient steering, (5) unfair competition. 12 as to the party offering the benefit, the law states in pertinent part: whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person . . . to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a federal health care program, shall be guilty of a felony . . . . 13 the section that applies to the recipient of the benefit provides in pertinent part: whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind . . . in return for purchasing, leasing, ————————————————————————————— 12. see, e.g., fraud & abuse laws, u.s. dep’t health & hum. serv’s. off. inspector gen.: compliance a roadmap for new physicians, https://oig.hhs.gov/compliance/physicianeducation/fraud-abuse-laws/ [https://perma.cc/b93s-cen7] (last visited oct. 19, 2024); see also e.g., united states v. ruttenberg, 625 f.2d 173, 177 n.9 (7th cir. 1980) (“[t]he law does not make increased cost to the government the sole criterion of corruption. in prohibiting ‘kickbacks,’ congress need not have spelled out the obvious truisms that while unnecessary expenditure of money earned and contributed by taxpaying fellow citizens may exacerbate the result of the crime, kickback schemes can freeze competing suppliers from the system, can mask the possibility of government price reductions, can misdirect program funds, and, when proportional, can erect strong temptations to order more drugs and supplies than needed.”). 13. social security act § 1128b(b)(2) (codified at 42 u.s.c. § 1320a-7b(b)(2)) (emphasis added). https://perma.cc/b93s-cen7 https://oig.hhs.gov/compliance/physician 2025] right-sizing inflation 35 ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a federal health care program, shall be guilty of a felony . . . .14 the civil administrative penalty provisions of the law (which include monetary penalties of $100,000 per violation plus three times the amount of prohibited remuneration and potential exclusion from fhcp participation)15 are enforced by oig, while the law’s criminal felony provisions (which under the federal alternative fines law can yield penalties of up to $250,000 per violation for individuals and $500,000 per violation for organizations, or twice the gain to the defendant, plus imprisonment for no more than ten years)16 are handled by the doj. in addition, courts generally have permitted cases brought under the “qui tam” provisions of the fca—that is, cases brought not by the government, but by private whistleblowers (or “relators”) that the government may or may not decide to join—to proceed, opening up the potentially much larger penalties of treble damages and assessments under that law. 17 thus, the enforcement risk under the aks comes not only from oig and doj, but also from disgruntled employees and competitors who may bring qui tam cases. based on analysis y of publicly-reported settlement data conducted by the author and team in researching this article, the author believes that in the last fifteen years, medical device makers have paid out at least $1.1 billion in settlements in fca cases.18 the aks has been broadly interpreted to apply where just one purpose of a business transaction is to induce fhcp business, even if there are other ————————————————————————————— 14. id. § 1128b(b)(1) (codified at 42 u.s.c. § 1320a-7b(b)(1)) (emphasis added). 15. id. § 1128a(a)(7) (codified at 42 u.s.c. § 1320a-7a(a)(7)); § 1128(b)(7) (codified at 42 u.s.c. § 1320a-7(b)(7)). 16. see 18 u.s.c. § 3571 (fines); 42 u.s.c. § 1320a-7b(b) (imprisonment). the aks’s criminal fine of not more than $100,000 essentially has been rendered obsolete by the federal sentencing law. compare 18 u.s.c. § 3571, with 42 u.s.c. § 1320a-7b(b). 17. see generally cases cited supra note 2; see also infra section iv. under 42 u.s.c. § 1320a-7b(g), any claim filed pursuant to an unlawful kickback is necessarily a false claim. 18. doj’s publicly-available statistics do not break down penalties by type of defendant, but this appears to represent a plausibly modest percentage of overall fca collections in the health care industry. for example, in 2021 alone, over $5 billion in settlements related to matters involving the health care industry as a whole. justice department’s false claims act settlements and judgments exceed $5.6 billion in fiscal year 2021, u.s. dep’t just.: press release (feb. 1, 2022), https://www.justice.gov/opa/pr/justice-department-s-false-claims-act-settlements-andjudgments-exceed-56-billion-fiscal-year [https://perma.cc/5mdb-3pzx]. see also false claims act settlements and judgments exceed $2 billion in fiscal year 2022, u.s. dep’t just.: press release (feb. 7, 2023), https://www.justice.gov/opa/pr/false-claims-act-settlements-andjudgments-exceed-2-billion-fiscal-year-2022 [https://perma.cc/8cpu-yfkk]; false claims act settlements and judgments exceed $2.68 billion in fiscal year 2023, u.s. dep’t just.: press release (feb. 22, 2024), https://www.justice.gov/opa/pr/false-claims-act-settlements-andjudgments-exceed-268-billion-fiscal-year-2023 [https://perma.cc/nxa3-td5e]. https://perma.cc/nxa3-td5e https://www.justice.gov/opa/pr/false-claims-act-settlements-and https://perma.cc/8cpu-yfkk https://www.justice.gov/opa/pr/false-claims-act-settlements-and https://perma.cc/5mdb-3pzx https://www.justice.gov/opa/pr/justice-department-s-false-claims-act-settlements-and indiana health law review [vol. 22:27 36 legitimate business purposes. 19 the government also takes the position that even remuneration that is earned solely on products or services that are not paid under fhcps may violate the law, if one purpose of the arrangement is to induce the “spillover” purchase, lease or use of other fhcp-covered products or services. 20 b. legislative history: rostenkowski on “conventional chain of sale” medical device sales agents, commissioned or otherwise, do not refer patients, nor purchase, order, or lease products, for which fhcp payment may be made. rather, they interact with health care professionals and institutional providers (and less frequently, patients) to provide the opportunity for those persons or entities to purchase, order, or lease the covered products. 21 accordingly, this analysis of the aks commission question focuses on the “arranging for or recommending” prong of the statute. treatment of commission-based sales and marketing arrangements under the aks has a long, and somewhat ambiguous, history. in the legislative history of amendments to the aks passed in 1977, then-house ways and means committee chairman dan rostenkowski commented that the law’s exception for payments to employees would protect “a distributor of equipment or supplies [who] pays a retailer on a commission basis for the use of his store to sell a product, [since] such payment would represent a legitimate payment to a legitimate agent employed in a traditional manner to sell a product. that is a simple extension of the conventional chain of sale.”22 ————————————————————————————— 19. united states v. greber, 760 f.2d 68, 72 (3d cir. 1985) (“if the payments were intended to induce the physician to use [defendant’s] services, the statute was violated, even if the payments were also intended to compensate for professional services.”), cert. denied, 474 u.s. 988 (1985). see also united states v. lahue, 261 f.3d 993, 1002 n.10, 1003–04 (10th cir. 2001) (finding that stare decisis effect of prior precedent adopting the “one purpose” test precluded defendant’s challenge to a lower court’s jury instruction that stated “[t]he intent to gain such influence must, at least in part, have been the reason the remuneration was offered or paid”) (emphasis in original); united states v. kats, 871 f.2d 105, 108 (9th cir. 1989) (adopting the “one purpose” test articulated in greber because “[e]ven if the physician performs some service for the money received, the potential for unnecessary drain on the medicare system remains.” (alteration in original) (quoting greber, 760 f.2d at 71)). 20. see, e.g., u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 00-01, (mar. 9, 2000) (“the mere ‘carve-out’ of federal health care program billing, however, does not end our inquiry, since such arrangements could have a ‘spillover’ effect on billing or coding for federal health care program items or services. where such effect occurs and is intended by one or both parties, the statute may be implicated.”). 21. though contact with patients is more rare, typically limited to dmepos, supra note 7, that are billed directly to patients and their payors, oig has often stated that targeting elderly and often ill medicare patients is a concerning suspect characteristic. see, e.g., u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 99-08 (july 6, 1999) (finding that a suspect characteristic is present if “the activity is specifically directed at senior citizens, medicaid beneficiaries, or other particularly vulnerable populations.”). 22. 123 cong. rec. h30280 (daily ed. sept. 22, 1977) (statement of rep. dan rostenkowski). 2025] right-sizing inflation 37 chairman rostenkowski went on to note, unsurprisingly, that on the other hand, payments from a laboratory to a physician or clinic that were made to induce referrals should not be protected merely because they are structured in the “guise” of an employment relationship. he stated the committee’s belief that “the substance rather than simply the form of a transaction should be controlling.”23 thus, rostenkowski seems to have made clear that where the “substance” of a transaction is a commission “to a legitimate agent employed in a traditional manner to sell a product,” the transaction should be protected from aks liability. iii. oig interpretation of commission sale arrangements a. regulatory history: rostenkowski v. oig despite this legislative history, many years later, when promulgating the first final “safe harbor” regulations in 1991, oig rejected the argument that commission sale arrangements should be covered under the employment exemption and the suggestion to create a separate safe harbor for such arrangements. 24 oig noted that chairman rostenkowski’s remarks had been made with respect to the house version of the bill (exempting payments “by an employer to an employee for employment in the provision of covered items or services”), 25 which differed from the senate version ultimately adopted by the conference (exempting payments “by an employer to an employee (who has a bona fide employment relationship with the employer) for employment in the provision of covered items and services”). 26 explaining its reasoning, oig went on to note that it would not extend the employment exception to commission sales agents because it was aware of “the existence of widespread abusive practices by salespersons who are independent contractors and, therefore, who are not under appropriate supervision and control.” 27 with this reasoning, oig rejected chairman rostenkowski’s remarks and created a distinction between commission-based payments to “bona fide employees” (which under the statutory exception are not restricted by any “fair ————————————————————————————— 23. id. 24. medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. 35971, 35981(july 29, 1991). 25. see h.r. rep. no. 95-393, pt. 2, at 8–12 (1977), as reprinted in 1977 u.s.c.c.a.n. 3039, 3056. 26. see h.r. rep. no. 95-673, at 6–10 (1977) (conf. rep.), as reprinted in 1977 u.s.c.c.a.n. 3113, 3115. 27. medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. at 35981. there is good reason to doubt this conclusion. see infra note 29. indiana health law review [vol. 22:27 38 market value” or “volume or value of referrals” language)28 and payments to anyone else. the legal distinction seems of dubious merit. one may wonder what is the legal difference between an “employment” relationship (which by definition is not an independent contractor relationship), and a “bona fide” (or “real”) employment relationship. read honestly, oig’s decision was based instead on a policy choice. relying, it seems, on a belief that sales conduct is better regulated in an employment situation, 29 oig established a bright line rule ————————————————————————————— 28. see 42 u.s.c. § 1320a-7b(b)(3)(b). the aks employment exception therefore should protect commission arrangements for employees, and in the pharmaceutical industry, sales representatives typically are the employees of the pharma company, where comparable kickback cases do not seem to have been brought. see, e.g., a day in the life of a pharmaceutical sales representative, medreps (jan. 27, 2022), https://www.medreps.com/medical-sales-careers/ what-do-pharmaceutical-sales-reps-do [https://perma.cc/e2st-43cl]. as noted above, this is generally not true in the medical device industry, where the sales agent often has a more handson role in working with health care professionals during the procedures in which the products are used, and the medical device industry encompasses a vastly larger number of product makers, most of which are much smaller and would lack the revenue to provide the full range of employment benefits to a sales force sufficiently large to reach the desired market. see kahn, supra note 3; o’connor, supra note 6. whatever the reason, the dominant sales rep model in medical devices is the commissioned, independent sales agent. id. 29. see, e.g., 56 fed. reg. at 35981; off. of inspector gen., advisory opinion no. 98-10, supra note 5 (“[b]ecause such agents are independent contractors, they are less accountable to the seller than an employee. for these reasons, this office has a longstanding concern with independent sales agency arrangements.” (citations omitted)). while, as a technical legal matter, employees may be more closely regulated than independent agents, there is good reason to doubt that independent medical device sales agents are, in fact, less regulated for aks purposes than they might be as employees. medical device makers largely adhere to the advamed code of ethics, which specifically imposes supervision requirements on both employed and contracted sales personnel. see advamed, advamed code of ethics 1, 35 (2023), https://www.advamed. org/wp-content/uploads/2023/06/2023-advamed-code-of-ethics.pdf. [https://perma.cc/vqa6g9yh]. consistent with the code, contracts between device makers and their “distributors” (see supra note 3) routinely require the agents to adhere to the maker’s compliance policies and undergo training. see id. further, oig’s program guidance for pharmaceutical manufacturers (made applicable to medical device makers in footnote 4) emphasizes the importance of “[c]onducting [e]ffective [t]raining and [e]ducation” of “officers, directors, employees, contractors, and agents” as part of a successful compliance program. oig compliance program guidance for pharmaceutical manufacturers, 68 fed. reg. 23731, 23740 (may 5, 2003). oig directs pharmaceutical and medical device manufacturers to “(i) develop a regular and comprehensive training program for its sales force, including refresher and updated training on a regular basis, either in person or through newsletters, memoranda, or the like; (ii) familiarize its sales force with the minimum phrma code standards and other relevant industry standards; (iii) institute and implement corrective action and disciplinary policies applicable to sales agents who engage in improper marketing; (iv) avail itself of the advisory opinion process if it has questions about particular practices used by its sales force; and (v) establish an effective system for tracking, compiling, and reviewing information about sales force activities, including, if appropriate, random spot checking.” id. at 23739. the industry also is only too aware that mandatory conditions for supervision may be imposed under corporate integrity agreements and deferred prosecution agreements, including activities of both employees and agents. see, e.g., off. of inspector gen., u.s. dep’t health & hum. servs., corporate integrity agreement https://perma.cc/vqa6 https://www.advamed https://perma.cc/e2st-43cl https://www.medreps.com/medical-sales-careers 2025] right-sizing inflation 39 that avoids the need to closely examine whether the relationship between a medical device maker and its contracted sales agent fits within the context of a “legitimate” and “conventional” agency relationship. b. regulatory guidance 1: “technical violations” v. “requisite intent to induce” although arguably inconsistent with pertinent legislative history (and therefore potentially vulnerable to attack), 30 oig’s position on commission sales/marketing arrangements is at least fairly clear: virtually all arrangements of this kind “may involve at least technical violations of the statute.” 31 this has ————————————————————————————— between the office of inspector general of the department of health of human services and amgen (2019) (requiring that amgen develop policies on how to ensure promotional functions, such as marketing by sales representatives, meet all health care laws); off. of inspector gen., u.s. dep’t health & hum. servs., corporate integrity agreement between the office of inspector general of the department of health of human services and avanir (2019) (requiring avanir create policies to control “the materials and information that may be distributed by avanir sales representatives” and “the development, implemental and review of all plans for sales representatives”); u.s. att’y’s off., dep’t of just., deferred prosecution agreement zimmer ¶¶ 10, 42 (2007) (stating that company shall adhere to advamed code of ethics and mandatory training and education of sales force “shall cover, at a minimum, all relevant federal health care laws and regulations, . . . and the obligations assumed by, and responses expected of, the [sales personnel] upon learning of improper, illegal, or potentially illegal acts relating to the company’s sales and marketing of hip and knee reconstruction and replacement products”). 30. while the often-stated “general rule” of statutory construction is that extrinsic evidence is used only in the case of a statutory ambiguity, an ambiguity need not be obvious in order to permit extrinsic evidence, and courts still go beyond even clear statutory language where the extrinsic evidence shows a different congressional intent. see, e.g., shambie singer & norman j. singer, sutherland statutes and statutory construction § 48.1 (clark boardman callaghan ed., 8th ed. 2022). moreover, federal courts generally give the same weight to floor statements by a committee chair in introducing and defending a bill that has been passed by their committee as to formal committee reports. see id. § 48.14. however, it would be a broad reading of loper bright to conclude that these principles of statutory construction would provide a basis for an administrative procedure act challenge that could compel oig to give any kind of “safe harbor” protection to “legitimate” and “traditional” commission sales/marketing arrangements. see supra note 11. 31. medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. at 35974. indeed, in another advisory opinion, oig makes the chilling observation that “any compensation arrangement between a seller and an independent sales agent for the purpose of selling health care items or services that are directly or indirectly reimbursable by a federal health care program potentially implicates the anti-kickback statute, irrespective of the methodology used to compensate the agent.” u.s. dep’t of health & hum. servs., off. of inspector gen., advisory op. no. 99-03, at 4–5 (mar. 16, 1999) (emphasis added). although oig has never relied on this broad a statement of the law in any enforcement proceeding that our research has located, the possibility that any payment to a sales agent—if the language is to be believed, even a fair market value payment not based on volume or value—may implicate the aks emphasizes the importance of separating out ordinary commissions to what rep. rostenkowski referred to as” conventional” sales agents from abusive arrangements utilizing persons with the ability to exercise “undue influence.” indiana health law review [vol. 22:27 40 been a consistent theme in oig’s analysis of such arrangements. 32 however, in public guidance oig also has consistently (i) declined to impose sanctions in situations where commissions are paid to bona fide independent sales agents, and (ii) qualified its views with the observation that the law “may” or “might” be violated. 33 together, these suggest not only that some commission sales/marketing arrangements do not warrant prosecution—because, in oig’s words, they amount, at most, only to “technical violations” and present a low risk of fraud and abuse—but also form the basis for an argument that there might be some instances where even a straightforward commission sales/marketing arrangement might not have the “requisite intent to induce referrals.” 34 before moving on to the “suspect characteristics, the absence of which oig has indicated warrants abjuring sanctions, 35 let us explore the important analysis that not every commission sales/marketing arrangement even has the “requisite intent to induce referrals” that is a prerequisite to even a “technical violation” of the aks. in a 1999 advisory opinion, oig considered whether payments from podiatrists to a shoe store where their services would be advertised (and where they would be authorized to make periodic appearances to consult with customers and sales associates) constituted prohibited remuneration under the aks. 36 the podiatrists would provide these services at no charge, would pay an ————————————————————————————— 32. see, e.g., off. of inspector gen., advisory op. no. 98–10, supra note 5 (declining to prosecute an arrangement under which a manufacturer of disposable medical supplies paid a commission to an independent sales agent based on a percentage of the manufacturer’s sales to hospitals or group purchasing organizations with which the sales agent had negotiated a contract for the manufacturer). 33. id. 34. another way of framing this analysis is to observe that the purpose of the aks is to prohibit payments to influence decision-making around orders of products/services, and not to prohibit payment for legitimate services. with that in mind, the question then becomes whether the mere fact that payment—not to the purchaser, but to the person performing a legitimate sales/marketing function—is calculated based on the number of sales ordered, sold or used is sufficient to demonstrate that prohibited intent? positing the answer to be “no,” this leads to the question of when is the sales agent’s service not “legitimate,” in turn leading to the “suspect” characteristics and especially to whether the sales agent is in a position to exercise “undue influence.” cf. united states v. miles, 360 f.3d 472, 474 (5th cir. 2004). 35. see, e.g., off. of inspector gen., advisory op. no. 98-10, supra note 5 (listing “suspect characteristics” in sales/marketing arrangements). the terminology of “suspect” or “questionable” “characteristics” or “features” or “factors” goes back to the preamble to the original safe harbor regulations, infra text accompanying note 41 (there are “many factors which are part of the decision-making process regarding case selection for investigation and prosecution”) (emphasis added); the first of oig’s special fraud alerts, 59 fed. reg. 65372, 65377 (dec. 19, 1994) (on joint venture arrangements, citing “questionable features of these suspect joint ventures” (emphasis added); and has been repeatedly used to indicate the presence (or absence) of the “requisite intent to induce referrals” in many oig advisory opinions. see, e.g., off. of inspector gen., advisory op. no. 98-10, supra; off. of inspector gen., advisory op. no. 99-03, supra note 31 (“suspect characteristics” in sales/marketing). 36. off. of inspector gen., advisory op. no. 99-08, supra note 21. 2025] right-sizing inflation 41 annual fixed fee to participate in the network of in-store podiatrists, and would be assigned on a rotating basis if a customer requested referral to a podiatrist. oig had little trouble determining that “in-store signs, special promotions, and authorized presence of the podiatrists” in the shoe department amounted to an “implied recommendation of the podiatrists” by the store, and therefore “come within the plain language of the statute, which prohibits payments to a person to ‘arrange for or recommend’ the purchasing or ordering of a good or service payable by a federal health care program.” 37 in characterizing these activities, oig also stated that “[i]f the requisite intent to induce or reward referrals . . . is present, the [aks] is violated.” 38 the “if” language here is noteworthy. “if” the signs and promotions amount to an implied recommendation, “within the plain language of the statute,” why is there any question about intent? is there any doubt that both the podiatrists and the store had an affirmative intent that the signs would imply a recommendation? accordingly, although oig does not characterize its analysis in this way, the “if” and “may” language in oig’s pronouncements suggests the basis for an argument that, at least in the case of payments to persons or entities with no status that would give them the ability to actually make or unduly influence ordering or buying decisions (e.g., persons who are not healthcare providers or other purchasing/ordering decisionmakers), applying the “arranging for or recommending” prong of the statute, the “requisite intent to induce referrals” must be demonstrated by the presence of “suspect” facts and circumstances. as we shall see, this is most commonly the ability to exercise “undue influence” over the purchase or order of the product or service. in other words, evidence that the parties’ intent is merely to compensate an independent sales agent to arrange for or recommend purchase of the covered product or service by itself arguably may not be sufficient scienter to violate the law in the first place. 39 ————————————————————————————— 37. id. 38. id. (emphasis added). 39. a recent second circuit decision, concluding that unlawful intent under the aks need not be a “corrupt” intent, is not to the contrary, and its procedural posture makes it wholly inapplicable. pfizer, inc. v. u.s. dep’t of health & hum. servs., 42 f.4th 67, 74 (2d cir. 2022). pfizer sought an advisory opinion from oig to the effect that a proposed patient co-pay assistance program for an expensive drug would not be an aks violation. the oig’s opinion concluded that the arrangement squarely implicated the law, offering “remuneration (the subsidy card) to a person (the medicare beneficiary) to induce that person to purchase an item (the medications) reimbursable under a federal health care program (medicare).” u.s. dep’t of health & hum. servs., off. of inspector gen., advisory op. no. 20-05, at 14–16 (sept. 23, 2020). pfizer sued in federal district court under, in pertinent part, the administrative procedure act, arguing that the oig’s opinion should be set aside as “contrary to law,” asserting that as a matter of law an aks violation requires a “corrupt” intent, and that no facts could be presented under which the program could be shown to be motivated by such intent. pfizer, 42 f.4th at 69. the district court held, and the court of appeals affirmed, that “corrupt” intent is not an aks requirement. id. since the case involved benefits to beneficiaries that were plainly designed to induce them to purchase pfizer’s indiana health law review [vol. 22:27 42 a recent supreme court decision also supports this conclusion. in united states v. hansen, the court held that when congress criminalized activity that “encourages or induces an alien to come to, enter, or reside in the united states [when such entrance or residence would be illegal]” 40 it used the terms “encourages or induces in their specialized, criminal law sense—that is, as incorporating common law liability for solicitation and facilitation [with a corrupt intent].”41 applying that decision to the use of the term “induce” in the aks leads to the conclusion that merely paying an incentive to a legitimate sales representative to make a sale of a lawful product to a lawful purchaser would not provide the payer or the recipient with the requisite mens rea to violate the law. c. regulatory guidance 2: “suspect” characteristics and factors putting aside whether commission sales/marketing arrangements lacking suspect characteristics might not even constitute “technical” violations of the aks—a case that, in light of hansen, likely soon will be made in defense of future aks enforcement proceedings—it is clear that, in the articulation of its enforcement posture, oig’s consistent approach to commission arrangements that might constitute “at least technical” violations is not to treat them as per se violations, but to assess them on a case-by-case basis under “the many factors which are part of the decision-making process regarding case selection for investigation and prosecution.” 42 in the specific context of commission ————————————————————————————— products—and not commissions to sales agents to compensate them for their sales services—on its face it has no application to the latter. moreover, the cases cited by pfizer on “corrupt” intent that were rejected by the courts held that under different statutes, an intent to induce had to have a criminal or otherwise nefarious element. id. at 75. in contrast, the argument that a device maker’s intent to induce sales agents to “arrange for or recommend” its products is not a kickback need not depend on whether that intent is “corrupt” or not; but rather may depend on whether that intent must be coupled with other “suspect characteristics” to constitute unlawful intent. furthermore, the holding of the second circuit case was simply that it was not contrary to law for oig to refuse to issue a favorable advisory opinion. id. at 73 (“pfizer filed this action . . . challenging, in relevant part, hhs oig's advisory opinion on the direct program as contrary to law under the administrative procedure act. . . . [and] the district court granted summary judgment to the government on the apa claim. . . .); see also id. at 80 (“we therefore affirm the judgment of the district court.”). it did not hold, because it was not presented with the question, that the intent to offer beneficiary remuneration in the proposed program did violate the aks. finally, the supreme court’s recent decision in united states v. hansen, 599 u.s. 762 (2023) and accompanying text, casts doubt on whether the second circuit’s reading of the aks in pfizer itself was correct in concluding that the intent to “induce” need not be a “corrupt” intent. for all of these reasons, pfizer does not shed any light on the question of whether paying a commission to induce a recommendation of a covered product constitutes even a “technical” violation of the aks. 40. 599 u.s. 762, 770 (2023). 41. id. at 774. 42. medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. at 35954. 2025] right-sizing inflation 43 sales/marketing arrangements, oig has stated that “[w]e, of course, recognize that many of these advertising and marketing activities do not warrant prosecution in part because (1) they are passive in nature, i.e., the activities do not involve direct contact with program beneficiaries, or (2) the individual or entity involved in these promotions is not involved in the delivery of health care.” 43 1. oft-cited “suspect characteristics” in its advisory opinions, oig has incorporated two principles (respectively, in numbers 1 and 2 below) into additional guidance as to what arrangements carry heightened fraud and abuse risk. these opinions identify a number of “suspect” characteristics that, if present, would cause it concern about a sales arrangement; however, in all six advisory opinions that address commission sales/marketing arrangements that, importantly, involve payments to truly independent sales personnel—not to persons in a position to exercise “undue influence” on a purchaser’s or patient’s ordering decision—oig always has found a low risk of fraud and abuse, and always has declined to impose any sanctions, even when some of the other suspect characteristics are present. 44 for pedagogical convenience, this article groups these characteristics into four categories (and skips the first characteristic—payment on a percentage of sales—because commission payment is the trigger for all of the potential violations in the commission advisory opinions): 2. suspect characteristics based on the nature of the sales agent a. “undue influence.” use of sales agents who are health professionals or persons in a similar position to exert undue influence on purchasers or patients. 45 ————————————————————————————— 43. id. at 35974. 44. the one commission advisory opinion that was negative fits the “undue influence” paradigm. see infra note 60 and accompanying text. 45. medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. at 35954. see also off. of inspector gen., advisory op. no. 99-08, supra note 21 (finding a suspect characteristic where the “party engaged in the marketing or promotional activity . . . . is involved in the delivery of health care (e.g. a doctor, a nurse, a home health aide, or the like) and whether the party is otherwise in a position to exert undue influence on potential purchasers or patients.”); u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 08-19 (oct. 29, 2008) (“marketing by health care providers and suppliers . . . . is subject to closer scrutiny, since health care providers and suppliers are in a position of trust and may exert undue influence when recommending health-care related items or services, particularly to their own patients.”). significantly, none of the favorable advisory opinions involve a person in this position, while the one unfavorable advisory opinion and the judicial decisions finding an aks commission violation uniformly involve persons in a position to exercise “undue influence.” see infra notes 54–59 (favorable advisory opinions), 60, 80–85 (undue influence found), and accompanying text. indiana health law review [vol. 22:27 44 3. suspect characteristics based on the nature of the audience a. targeted to the vulnerable. the target audience is the activity “specifically directed at senior citizens, medicaid beneficiaries, or other particularly vulnerable populations.” 46 b. contact with the vulnerable. direct contact between the sales agent and fhcp beneficiaries prior to the prescribing or dispensing of the product. 47 c. physicians and hcps. direct contact between the sales agent and physicians in a position to order items or services that are then paid for by a fhcp.48 4. suspect characteristics based on the nature of the activity a. passive or non-coercive v. coercive. the nature of the marketing or promotional activity, “to what degree the activity may be coercive . . . . for example, [with respect to patients] door-to-door marketing, telephone solicitations, and direct mailings are more intrusive, and typically pose a greater potential for abuse than truthful passive advertising in general circulation newspapers or on television.” 49 ————————————————————————————— 46. off. of inspector gen., advisory op. no. 99-08, supra note 21. 47. see, e.g., off. of inspector gen., advisory op. no. 98-10, supra note 5. (importantly, oig clearly views the potential for contact with vulnerable patient populations as less problematic than arrangements that “specifically target” such arrangements.); see also, e.g., off. of inspector gen., advisory op. no. 99-08, supra note 21 (approving marketing arrangement that, “while it involves direct patient contact, the arrangement is not targeted at federal health care program beneficiaries.” (emphasis added)). 48. see, e.g., id. in practice, evidence suggests that the importance of this characteristic is to be doubted. although oig has named direct contact between sales agents and physicians as a suspect characteristic, it not only has declined to impose sanctions where such direct contact was present, see, e.g., off. of inspector gen., advisory op. no. 99-03, supra note 31 (declining to impose sanctions despite there being contact between sales agents and physicians), but has affirmatively cited the “less vulnerable” nature of hcps as a reason not to impose sanctions even when marketing is targeted at hcps. see, e.g., u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 99-10 (oct. 25, 1999) (declining to impose sanctions despite marketing activities that would directly target physicians, respiratory therapists, and other health care professionals because this was a “less vulnerable audience” to inappropriate inducement than the patient population.). 49. off. of inspector gen., advisory op. 99-08, supra note 21. see also medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. at 35954 (“we, of course, recognize that many of these advertising and marketing activities do not warrant prosecution in part because (1) they are passive in nature, i.e., the activities do not involve direct contact with program beneficiaries . . . .”); u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no.19-04 (sept. 5, 2019) (“the advertising activity under the proposed arrangement is essentially passive in nature because any contact with requestor must be initiated 2025] right-sizing inflation 45 5. suspect characteristics based on the nature of the product a. direct billing of a fhcp by the seller for the item or service sold by the sales agent.50 b. marketing of items or services that are separately reimbursable by a fhcp (e.g., items or services not bundled with other items or services covered by a drg payment), whether on the basis of charges or costs. 51 c. whether the item or service is one for which there is a likelihood of overutilization based on the historical experience of fhcps, reimbursement methodology, or other reason. 52 as discussed below, oig’s own advisory opinions support an interpretation of the statute concluding that while a percentage commission may be the trigger for the inquiry, it is only the presence of other suspect characteristics that even call for closer scrutiny. although oig has noted that “the more factors that are present, the greater the scrutiny we ordinarily will give an arrangement,” 53 except in one instance, discussed below, involving dmepos sales (therefore potentially implicating the suspect factors of undue influence on a “vulnerable” patient population), 54 no combination of suspect factors has ever resulted in a negative advisory opinion about ordinary commissions to independent sales agents. most important, as discussed more fully in section iv, despite sometimes inconsistent rhetoric and dicta, it is really only the presence of one such characteristic—“undue influence” on a purchaser’s or patient’s ordering decision—a characteristic almost unique to selling to vulnerable rather than sophisticated audiences that, based on oig’s advisory opinions and the facts in the decided cases, turns a commission into a kickback. ————————————————————————————— by a federal health care program beneficiary. unlike more direct forms of advertising, such as emails, mailings, or text messages, requestor’s advertisements for providers would be visible to federal health care program beneficiaries only if they visit the marketplace . . . .’). 50. see, e.g., off. of inspector gen., advisory op. no. 98-10, supra note 5. as discussed supra note 7, this characteristic almost never is present for medical devices used in medicare patients except for dmepos, which, since such items are sold direct to patients, means that this characteristic nearly always also implicates the undue influence/vulnerable audience factors (#s 1, 2a and 2b above). 51. see off. of inspector gen., advisory op. no. 98-10, supra note 5 (as with direct billing by the seller, this factor is almost never present in medical device sales except dmepos). see supra note 48. 52. off. of inspector gen., advisory op. no. 99-08, supra note 21. 53. off. of inspector gen., advisory op. no. 99-03, supra note 31. 54. see infra note 60. indiana health law review [vol. 22:27 46 6. application of “suspect characteristics” in advisory opinions as noted, except in one dmepos (“vulnerable audience”) case, oig has never issued a negative advisory opinion in a commission sale-type situation. in all six of its other commission opinions—despite the existence of a sales-based payment to the sales agent and despite the presence of one or more of the potentially “suspect” characteristics—oig found a low risk of fraud and abuse and determined that it would not impose sanctions. a. the rule: no combination of suspect factors sufficient to warrant enforcement (i) nature of sales agent: commission to independent sales agent allowed. the simplest example involved a commission to an independent sales agent where oig found no suspect factors (other than the percentage commission itself). here, a manufacturer of disposable medical supplies paid a commission to an independent sales agent based on a percentage of the manufacturer’s sales to hospitals or group purchasing organizations (“gpos”) with which the sales agent had negotiated a contract for the manufacturer. hospitals and gpos are not vulnerable audiences, and the ordinary sales rep had no other relationship giving rise to the potential for undue influence. the products were not separately paid for, and oig saw no coercive tactics. 55 (ii) nature of audience: contact with persons in a position to order the services or beneficiaries allowed. (1) direct contact with ordering persons insufficient for enforcement. in one advisory opinion that involved contact with hcps, oig declined to prosecute an arrangement in which a manufacturer of therapeutic air mattresses used to treat and prevent pressure ulcers would pay an independent supplier a commission on sales of the air mattresses to skilled nursing facilities.56 as with hospitals and gpos, nursing facilities are not vulnerable audiences, so the sales agent had no relationship that would provide undue influence, no coercive tactics were noted and the products were not separately paid for. (2) direct contact with beneficiaries insufficient for enforcement. even contact with a vulnerable audience, by itself, has not been enough absent other suspect factors. the podiatrist/shoe store advisory opinion did not ————————————————————————————— 55. off. of inspector gen., advisory op. no. 98-10, supra note 5. 56. off. of inspector gen., advisory op. no. 99-03, supra note 31. 2025] right-sizing inflation 47 involve a sales-based fee, but it did involve direct contact between the sales agents and beneficiaries, and potentially separately reimbursable podiatrist services. oig concluded this posed a low risk of fraud and abuse because the marketing did not target fhcp beneficiaries—though the patient “targets” were anyone in the shoe store who might need a podiatry evaluation, suggesting that a likely focus on the elderly was deemed insufficient—and involved patient education that was not “coercive” in nature. (iii) nature of activity: passive advertising and non-coercive patient education allowed. similar to the independent sales agent situation, oig favorably examined a technology company’s proposal to allow fhcp beneficiaries to use its online healthcare directory to search for providers and book medical appointments through the technology platform. 57 health care providers—here, the “product” being sold was appointments for their professional services—would pay the company a “per-click” or per-booking fee to be listed in the directory and could purchase sponsored advertisements on the website. 58 distinguishing these circumstances from “white coat” marketing to beneficiaries, surely the paradigm of “undue influence,” oig concluded that enforcement was not warranted given the technology company was not a healthcare provider and the advertising was accessible only after proactive searches by potential patients. 59 (iv) nature of the product: separately reimbursable service directly billed by the seller allowed. (1) podiatrists redux as noted above, the services of the podiatrists in that advisory opinion would be separately reimbursable and billed by the selling podiatrists, who would have direct contact with beneficiaries, yet oig concluded that such contact was neither targeted at beneficiaries nor coercive, thus finding that the separately reimbursable and directly billed “product” did not warrant enforcement. 60 ————————————————————————————— 57. off. of inspector gen., advisory op. no. 19-04, supra note 48. 58. id. oig also noted that by scheduling appointments on behalf of fhcp beneficiaries, the company would be “arranging for the furnishing of federally reimbursable items and services in exchange for the payment of fees,” and by displaying search results, as well as providers’ sponsored advertisements, the company engages in “advertising activities meant to induce the use of an item or service.” id. at 7-8. 59. id. at 8-9; see also off. of inspector gen., advisory op. no. 08-19, supra note 44 (finding that a similar internet advertising arrangement where chiropractors would pay a per-call or perlead fee in exchange for being listed on the website’s platform, which potential patients could use to search for chiropractors in their area, would present minimal risk of abuse). 60. off. of inspector gen., advisory op. no. 99-08, supra note 21. indiana health law review [vol. 22:27 48 (2) overutilization none of these commission advisory opinions found a risk of overutilization, despite potentially separate reimbursement being available in the podiatrist case and the medical technology case. b. the exception: dmepos, no-charge loaner products, and unsafeguarded risks warrant enforcement. oig has only once issued a negative advisory opinion in a commission situation, noting a plethora of suspect characteristics and no safeguards against abuse. here, the commissioned sales agent was itself a medicare supplier, thus implicating the nature-of-agent suspect factor, and the products were dmepos, thus implicating the direct-contact-with-vulnerable-audience/undue influence suspect factor. in addition, the agent consigned product to customer physician offices for the physicians to dispense as temporary “loaners” while the claims were pending, thus giving the referring physicians the direct financial benefit of a no-charge inventory to use with their patients, and oig specifically noted that the arrangement had no safeguard against the potential for “improper payments” to the physicians.61 what thus emerges from a review of the commission advisory opinions is that although oig has indicated characteristics where scrutiny is called for, a commission based on market conditions, paid to an ordinary independent sales agent, even where the sales agent would be likely to have contact with persons in a position to order, should not in itself warrant aks enforcement. even contact with beneficiaries should not be sufficient absent the specific targeting of a vulnerable beneficiary audience, the use of “coercive” marketing tactics like door-to-door solicitation, or (as in the dmepos “exception” discussed above) other unusual circumstances and/or adjacent kickback risks without reasonable safeguards. 62 as discussed more below, the one suspect characteristic present in nearly all judicial decisions and doj enforcement involving sales agent commissions is that the person receiving the commission is not an ordinary sales agent, but is ————————————————————————————— 61. u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 98-01 n.6 (mar. 19, 1998) (highlighting that oig was also troubled by the fact that the sales agent/supplier would be charging “medicare prices” substantially in excess of the product maker’s list price. in other words, charging medicare more than private payers, albeit within the medicare fee schedule. while not specifically cited by oig, the “substantially in excess” language indicates that oig was signaling another abuse; oig’s authority to exclude entities from medicare participation for submitting bills for charges substantially in excess of the entity’s usual charges.); see also 42 c.f.r. § 1001.701(a)(1) (2017). 62. the amount of commission is rarely discussed, but in one advisory opinion oig spoke approvingly of “a fixed percentage, which company a has represented will be fair market value in an arms-length transaction.” off. of inspector gen., advisory op. no. 99-03, supra note 31. 2025] right-sizing inflation 49 instead a person who is making use of “undue influence” over a person who is in a position to bring about sales. although “undue influence” is sometimes found in the relationship with the ordering health care provider, more commonly it has been the key factor in assessing the recommender’s relationship to the patient when leveraged in the sales/marketing process. iv. judicial interpretation a. the classic view: arranging for or recommending has to be done by a relevant decisionmaker as noted above, in the context of commission sales, it is the “arranging for or recommending” prong of the aks that is at issue. although there were not many cases at the turn of the millennium parsing the meaning of “arranging for” or “recommending” under the aks, it is clear that case law did not support the idea of a criminal aks violation for mere sales/marketing activity, and courts always required something more to support a conviction. 63 two cases illustrate this classic judicial approach, which turned on whether the recipient of the remuneration was the relevant decisionmaker. in united states v. miles, the government prosecuted the principals and employees of a home health care agency, for allegedly paying kickbacks to a “public relations firm” for referral of medicare patients. 64 under the arrangement at issue, the agency hired the firm to distribute information about its home health care services, including literature and business cards, to doctors ————————————————————————————— 63. see supra note 9 and infra section iv.b. easily distinguished is a line of private contract avoidance cases, voiding commission contracts as against public policy. it is notable that none of these cases has ever been cited as precedent in any of the aks commission enforcement cases, suggesting that courts do not find them applicable. there are several good reasons for this. perhaps most important, these decisions are inapplicable to aks enforcement because they were civil breach-of-contract cases, subject only to the preponderance of evidence standard and calling for different elements of proof. as the trial judge reasoned in one such case, it is not necessary to establish all elements of an aks criminal (or even civil monetary penalty) violation in order to determine that a contract may be void as against public policy. medpricer.com v. becton, dixon & co., 240 f. supp. 3d 263, 274-75 (d. conn. 2017). moreover, three of the five cases lacked binding precedential value for a judicial circuit or a state: two were federal district court cases, see id.; see also zimmer, inc. v. nu tech med., inc., 54 f. supp. 2d 850 (n.d. ind. 1999), and another one was decided by an intermediate state court. see med. dev. network, inc. v. pro. respiratory care/home med. equip. servs., inc., 673 so. 2d 565 (fla. dist. ct. app. 1996). finally, in each of the remaining two cases, which a federal court of appeals affirmed, it does not appear that the courts were presented with arguments based on oig’s suspect characteristic analysis but rather applied the language of the law and/or precedent from non-commission aks cases to reject technical arguments on the applicability of a safe harbor. compare joint tech., inc. v. weaver, no. civ-11-846-m, 2013 wl 257075, at *2-3 (w.d. okla. jan. 23, 2013) (employment safe harbor not available to independent contractor), aff’d, 567 f. app’x 585 (10th cir. 2014), with nursing home consultants, inc. v. quantum health servs., inc., 926 f. supp. 835, 844 (e.d. ark. 1996) (personal services safe harbor not available where compensation not fixed in advance), aff'd, 112 f.3d 513 (8th cir. 1997). 64. 360 f.3d 472, 474 (5th cir. 2004). https://medpricer.com indiana health law review [vol. 22:27 50 in the area. when a doctor determined that home health care services were needed for a patient, the doctor could contact the firm with the patient's information. the firm, in turn, provided the patient's information to the home health agency, which would deliver the necessary services ordered by the physician to patients. the agency paid the public relations firm $300 for each client it received this way. 65 despite these payments, the fifth circuit reversed the defendant’s aks convictions, noting that the referring physicians did not receive any remuneration under the arrangement that could affect their referral decisionmaking and that the arrangement “did not unduly influence the doctors’ decisions.” 66 that the pr firm received a payment seems not even to have been relevant to the court’s decision, because the firm was not the relevant decisionmaker, nor in a position to exert undue influence on the relevant decisionmaker. the miles court contrasted its conclusion with another circuit's decision to affirm aks convictions, where the court concluded that the sales representative was the relevant decisionmaker. in united states v. polin, the seventh circuit affirmed the aks convictions of employees of a pacemaker monitoring service, which paid the sales representatives of a pacemaker medical device maker $50 in cash for each medicare patient that was referred to their monitoring center. 67 in this case, the sales representatives were responsible for patient follow-up after implantation, including arranging for ongoing monitoring of the implanted device.68 as such, the court concluded that the sales agent effectively was the decisionmaker as to which monitoring service would receive the business and that the agent’s recommendation amounted to a selection since the suggestion was never once refused. 69 the critical issue in both of these cases was who made the decision to refer a patient for services reimbursed by medicare: “[u]nder our reading of the statute, because the salesman in polin was the relevant decisionmaker and his judgment was shown to have been improperly influenced by the payments he received from the monitoring service, the seventh circuit correctly upheld the conviction of the individuals who paid the salesman. . .” 70 in contrast, in miles, ————————————————————————————— 65. id. at 479. 66. id. at 480. 67. 194 f.3d 863, 864 (7th cir. 1999). 68. id. at 864-65. 69. id. at 866 (“once it was decided that the patient would be sent to an outside service for monitoring, [the sales representative] would suggest [defendants] or a similar service to the physician. never in his fourteen year career was [the sales representative's] suggestion rebuked by a physician. indeed, after his recommendation was made, he would call [the monitoring service] and arrange for the patient's follow-up himself. of course, [the monitoring service] would have to receive the physician's authorization before commencing service, but that permission seemed to be more of a formality or rubber stamping of [the sales representative's] referral.”). 70. miles, 360 f.3d at 480–81 (emphasis added). 2025] right-sizing inflation 51 the “relevant decisionmakers” were the physicians who determined that a patient required home health care services, and because those physicians were not paid to influence their choice of home health care providers, the payments to the marketing firm for advertising the home health agency’s services did not violate the statute. 71 b. variation: the recipient with “undue influence” as noted above, research did not locate any aks enforcement cases holding that commissions to independent sales representatives were kickbacks until the turn of the current century. 72 since then, a number of federal appeals courts have upheld aks criminal convictions based on commission-type payments for arranging for or recommending covered products to be used in the care of medicare patients, and several of those decisions have also described those commissions as, or as equivalent to, per se aks violations.73 however, as discussed further below, a close reading of these decisions results in the conclusion that they are consistent with oig’s historical guidance and the miles court’s rationale: commissions are a kickback only when paid to a decisionmaker, or someone in a position to exercise “undue influence” over that decision. 1. “[g]arden variety” undue influence: payments to doctors and buyer employees the second circuit has characterized payments to the referring physicians as a “garden-variety kickback scheme.” 74 in another recent decision, the fourth ————————————————————————————— 71. id. at 479-80. 72. see supra note 62 (citing note 9 and contract avoidance cases). 73. see cases cited supra note 2. 74. see, e.g., united states v. krikheli, no. 09-cr-725, 2009 wl 4110306 (e.d.n.y. nov. 24, 2009) (physicians personally, or through intermediaries, arranged for patients to be referred to a radiological testing facility operated in exchange for payments to the referring doctors and the physicians), aff'd, 461 f. app’x 7 (2d cir. 2012) (non-precedential); see also united states v. medoc health servs., llc, 470 f. supp. 3d 638, 645 (n.d. tex. 2020) (physicians were made owners of management services organizations for pharmacies and received “profits” based on their referrals to those pharmacies). see also press release: seven texas doctors and a hospital ceo agree to pay over $1.1 million to settle kickback allegations, dep’t of just. (jan. 20, 2022), https://www.justice.gov/usao-edtx/pr/seven-texas-doctors-and-hospital-ceo-agree-payover-11-million-settle-kickback [https://perma.cc/mj38-wuvs]; press release: ten texas doctors and a healthcare executive agree to pay over $1.68 million to settle kickback allegations, dep’t of just. (mar. 22, 2022), https://www.justice.gov/usao-edtx/pr/ten-texasdoctors-and-healthcare-executive-agree-pay-over-168-million-settle-kickback [https://perma.cc/ 38la-vtan]; press release: mcallen woman pleads guilty to multi-million dollar kickback conspiracy, dep’t of just. (mar. 7, 2019), https://www.justice.gov/usao-sdtx/pr/mcallenwoman-pleads-guilty-multi-million-dollar-kickback-conspiracy [https://perma.cc/vr4dhttps://perma.cc/vr4d https://www.justice.gov/usao-sdtx/pr/mcallen https://perma.cc https://www.justice.gov/usao-edtx/pr/ten-texas https://perma.cc/mj38-wuvs https://www.justice.gov/usao-edtx/pr/seven-texas-doctors-and-hospital-ceo-agree-pay indiana health law review [vol. 22:27 52 circuit upheld criminal aks convictions of the owners of a clinical laboratory for paying, and independent sales representatives for receiving, commissions; but the facts make the result consistent with oig’s principles, because the lab (through the involvement of the sales representatives) was also paying the physicians a per test-order “process and handling fee.” 75 likewise, courts have had little difficulty finding kickbacks in payments made to employees of the referring provider. 76 in these cases, there is no need for the court to articulate the presence of “undue influence” because direct payment to those in a position to influence or select the product or service makes it obvious. 77 2. further articulating the “undue influence” standard putting aside the low-hanging fruit of payments to the referring doctors and the doctors’ employees, courts have applied the concept to other insiders who are deemed to be either in a position to make directly, or as a practical matter bring about, the decision as to whether the product or service should be ————————————————————————————— vwv3] (texas pharmacy marketer pleaded guilty when she paid physicians to write expensive compound drugs). payments to providers have also been a common theme in fca settlements with compounding pharmacies who paid physicians for prescribing pain creams that would be filled at specific pharmacies which they controlled. see, e.g., press release: three physicians and five marketers charged for violations to federal anti-kickback statutes, dep’t of just. (june 13, 2019), https://www.justice.gov/usao-ndok/pr/three-physicians-and-five-marketers-chargedviolations-federal-anti-kickback-statutes [https://perma.cc/xc2c-u7ln]; press release: compounding pharmacy, two of its executives, and private equity firm agree to pay $21.36 million to resolve false claims act allegations, dep’t of just. (sept. 18, 2019), https://www.justice.gov/opa/pr/compounding-pharmacy-two-its-executives-and-private-equityfirm-agree-pay-2136-million [https://perma.cc/ja7p-ej2z] (payments from compounding pharmacy to telemedicine prescribing doctors, including copayment waivers and sham charitable foundation). 75. united states ex. rel. lutz v. mallory, 988 f.3d 730, 735 (4th cir. 2021). in upholding the conviction of one of the sales reps for receiving unlawful remuneration, the mallory court specifically noted that in communicating with the physicians, rep “emphasized [their] ability to profit from p&h fees, a key component of the [g]overnment’s case.” id. at 740. of course, even this case does not stand for the proposition that all payments to physicians for services to a business that benefits from their referrals are kickbacks. not only were the physicians not defendants in the appeal, the court emphasized that the profit-motive discussions, and repeated warnings from counsel about the arrangement, showed an intent by the sales agents to exercise undue influence by using the p&h payments as a kind of bribe. id. at 739-40. 76. see, e.g., united states v. st. junius, 739 f. 3d 193, 215 (5th cir. 2013); united states v. robinson, 505 f. app’x 385, 388 (5th cir. 2013) (unpublished). in both cases, kickback convictions were upheld for commission-type payments to employees or contractors of healthcare providers for mining their employer’s databases and passing the information on to product sellers. 77. similarly, it is easy to see that payments to patients are also low-hanging fruit. see press release: houston nurse guilty in east texas health care kickback scheme, dep’t of just. (mar. 6, 2020), https://www.justice.gov/usao-edtx/pr/houston-nurse-guilty-east-texas-health-carekickback-scheme [https://perma.cc/82jy-l9ng]. see also united states v. lobe, no. 18-cr00040-rws, 2020 u.s. dist. lexis 40874, at *1 (e.d. tex. mar. 6, 2020). https://perma.cc/82jy-l9ng https://www.justice.gov/usao-edtx/pr/houston-nurse-guilty-east-texas-health-care https://perma.cc/ja7p-ej2z https://www.justice.gov/opa/pr/compounding-pharmacy-two-its-executives-and-private-equity https://perma.cc/xc2c-u7ln https://www.justice.gov/usao-ndok/pr/three-physicians-and-five-marketers-charged 2025] right-sizing inflation 53 prescribed or used, or who should supply it. the fifth circuit’s decision in miles summarizes this “undue influence” rule succinctly: where advertising facilitates an independent decision to purchase a healthcare good or service, and where there is no evidence that the advertiser “unduly influence[s]” or “act[s] on behalf of” the purchaser, the mere fact that the good or service provider compensates the advertiser following each purchase is insufficient to support the provider's conviction for making a payment “to refer an individual to a person” under [the aks]. 78 3. undue influence absent: ordinary sales calls on providers as discussed above, miles itself applied this rule to vacate an aks conviction for per-patient payments when the recipients were, in effect, just independent sales agents, with no ability to exert “undue influence.” 79 the court’s description of the “professional marketers” tracks that of an independent sales agent. the marketers working for the home health agency would visit physicians and provide them with their contact information and promotional materials about their client. physicians who wanted to make a referral to the agency for which the marketers worked would send a patient’s contact information to the marketers, and the marketers would pass along the referral. the court observed that the marketers had no decision-making authority and “did not unduly influence the doctors’ decisions.” 80 without evidence of undue influence on the purchasing decisionmaker or patient, or other suspect characteristics, the commissions paid to the public relations firm, although based on each patient referred, did not meet the definition of a prohibited referral within the meaning of the aks. 81 4. “undue influence” found there would be little reason to write this article if the miles rule were a free pass for all cases involving commissions, and in other cases, the court has found, sometimes expressly, sometimes implicitly, that “undue influence” was present. however, in each such case, it is evident that, unlike the situation of a legitimate independent sales agent, the recipient of the payment was in a position to make or bring about the referral. ————————————————————————————— 78. united states v. shoemaker, 746 f.3d 614, 628 (5th cir. 2014) (quoting united states v. miles, 360 f.3d 472, 480 (5th cir. 2004)). 79. see united states v. miles, 360 f.3d 472, 479-81 (5th cir. 2004). 80. id. at 480. 81. see id. indiana health law review [vol. 22:27 54 a. pressuring the boss in united states v. shoemaker, the fifth circuit upheld the conviction of the owner of a nurse staffing business, who paid the board chair of a community hospital five dollars for every hour of work his contract nurses billed at the hospital, and the board chair, in turn, pressured the hospital ceo to increase the hospital’s use of the business’s contract nurses. 82 the facts of shoemaker presented an “archetypal example of the undue influence prohibited by the [aks],” as the evidence clearly showed that the chair received payments not to distribute a brochure about the nursing company to hospital staff or engage in any form of traditional marketing, but rather to exploit his relationships with hospital executives to steer business towards the company. 83 b. vulnerable audiences these cases all involve “undue influence” resulting from the unique vulnerability of elderly and disabled patients. (i) “patient recruiters” in two related cases, the fifth circuit upheld aks convictions for “patient recruiters” who exerted undue influence by seeming to befriend and even bribe patients to join a partial hospitalization program. the recruiters visited group homes and assisted living facilities to recruit patients by giving residents gifts, including cigarettes, paying their co-payments, and driving patients to the program. one patient recruiter owned a boarding house and required her residents to attend the partial hospitalization program, while other recruiters made payments to the owners of group homes they visited based on the number of beneficiaries from that home who attended the program. 84 ————————————————————————————— 82. united states v. shoemaker, 746 f.3d 614, 616, 627 (5th cir. 2014). 83. see id. at 629. 84. see united states v. gibson, 875 f.3d 179, 186-89 (5th cir. 2017). the gibson court made a point of distinguishing the benign marketing services in miles. id. at 190-91; see also united states v. ricard, 922 f.3d 639, 641 (5th cir. 2019) (affirming the conviction of a patient “recruiter” who received a flat fee for each home health referral, all of whom came from the behavioral health center where her fiancé worked). see also united states v. george, 900 f.3d 405 (7th cir. 2018) aff’g 171 f. supp. 3d 810 (n.d. ill. 2016) (affirming the conviction of the defendant who, according to the government’s brief, “went directly to medicare beneficiaries, got their information, and made the decision herself to refer those patients to [the agency], rather than having doctors or patients make those decisions themselves.”); united states v. williams, 218 f. supp. 3d 730, 738-39 (n.d. ill. 2016) (defendant, a patient “recruiter”, called medicare beneficiaries to collect information that was transmitted to a home health agency in exchange for a per-patient referral fee). the ninth circuit affirmed an aks conviction in united states v. adebimpe, 649 f. app’x 449, 455 (9th cir. 2016) (affirming the conviction of a recruiter who 2025] right-sizing inflation 55 (ii) deceitful offers of “free” dmepos and coercive marketing dmepos suppliers are particular favorites for “undue influence” convictions, both because such products are separately paid for by fhcps, and marketed directly to patients, who are perceived as more vulnerable to undue influence than health care providers. 85 in these cases, the “undue influence” often consists of outright deception and violation of other patient protection rules in the sales/marketing process. in united states v. turner, for example, the court upheld the aks conviction of a “recruiter” of medicare beneficiaries for dme arthritis kits in exchange for a per-beneficiary fee. 86 the court found that the recruiter used telemarketers to contact beneficiaries before a device had been prescribed or dispensed to falsely inform them that they were entitled to free arthritis kits (ignoring the 20% co-insurance for dme supplies, and potentially in violation of the prohibition on dme telemarketing). 87 c. effective decisionmaker as discussed above, in polin, the court upheld the conviction of employees of a cardiac pacemaker monitoring service for paying a per-patient fee to the pacemaker manufacturer sales representatives whom the court found effectively controlled the decision as to which monitoring service would be used.88 in sum, while not always using oig’s term “undue influence,” in each of these cases the court’s finding of a violation (or, as occasionally reflected in the footnotes, the government’s allegations in bringing or joining or settling the ————————————————————————————— collected information directly from medicare beneficiaries and sent it to a medical supply company). 85. compare off. of inspector gen., advisory op. no. 99-08, supra note 21 (stating that senior citizens and medicaid beneficiaries are “particularly vulnerable” populations), with off. of inspector gen., advisory op. no. 99-10, supra note 5 (stating that health care professionals are a “less vulnerable audience”). see supra notes 45-46 and accompanying text. 86. 561 f. app’x 312, 316-17 (5th cir. 2014). 87. id.; see also united states v. brown, 871 f.3d 352, 354-55 (5th cir. 2017) (obtaining medicare numbers directly from beneficiaries, selling the information to dme and home health companies, and arranging with specific doctors to “rubber stamp” orders); second amended complaint, united states ex rel. herman v. coloplast corp., no. 11-cv-12131-rwz (d. mass. june 1, 2015), ecf no. 40 (intervened false claims act case alleging that suppliers and marketers of dme ostomy and continence care products used pre-existing relationships with patients to switch to defendants’ products). cf. united states ex rel silva v. vici mktg., llc, 361 f. supp. 3d 1245, 1248-49 (m.d. fla. 2019) (excerpting complaint at 2, united states ex rel. silva v. z stat med., llc, no. 15-cv-00444, ecf no. 39 (m.d. fla. oct. 18, 2018)) (intervened false claims act case involving direct marketing to patients of pain cream products). 88. united states v. polin, 194 f.3d 863, 866 (7th cir. 1999); see also united states v. vernon, 723 f.3d 1234, 1254 (11th cir. 2013) (“patient advocate” was “effectively responsible for deciding which pharmacy to use for the filling of patients’ prescriptions”); united states v. george, 171 f. supp. 3d 810, 815 (n.d. ill. 2016) (“like the defendants in vernon, defendant [whom the court noted was also a “certified homemaker”] was effectively responsible for deciding which home health service the patients used” (citing united states v. vernon, 723 f.3d 1234, 1254 (11th cir. 2013)). indiana health law review [vol. 22:27 56 case) relied on facts that support a high degree of “undue influence” over the referral. “undue influence” has been the crux of the violation where the recipient has authority over the decisionmaker, 89 or is found to be the effective decisionmaker, 90 and most often when the recipient of the remuneration is dealing with a vulnerable (usually elderly, usually ill) beneficiary population: bearing gifts, free transportation, untrue offers of “free” products, door-to-door solicitation. 91 these decisions highlight the need for enforcement and sanction where the recipient of the commission is in a position to engage in, and has engaged in, the use of “undue influence” to bring about sales. conversely, they do not support the conclusion that a commission to a truly independent sales agent, not in such a position, should be the basis for an aks violation. v. conclusion in light of the law’s purposes and legislative history, administrative guidance and the results of these enforcement actions, together with the supreme court’s recent interpretation of “induce” in hansen, the best reading of the aks is that commission-based arrangements with independent sales agents should be protected from aks enforcement or liability so long as the relationship with those agents represents “a legitimate payment to a legitimate agent employed in a traditional manner to sell a product.” 92 oig’s advisory opinions describe the suspect characteristics that help identify whether the arrangement is in fact a legitimate payment to a legitimate agent. 93 there can be no serious argument that this would conflict with any of the aks’s purposes. legitimate sales agents do not control the ordering of the products they sell. those decisions are made by health care professionals and providers, so merely incentivizing the sales agent cannot reasonably contribute to overutilization, increased program costs, corruption of medical judgment, patient steering, or unfair competition. 94 the legislative history supports an exemption for commission sales agents. oig’s advisory opinions support this conclusion and describe the suspect characteristics that help identify whether the arrangement is in fact a legitimate payment to a legitimate agent. despite ————————————————————————————— 89. united states v. shoemaker, 746 f.3d 614, 629 (5th cir. 2014). 90. see united states v. tuner, 561 f. app’x 312, 316-17 (5th cir. 2014). 91. id. 92. 123 cong. rec. h30280 (1977) (statement of rep. rostenkowski). whether protection should arise from the employment exception, as chairman rostenkowski stated, or in some other way, is a technical point that could be resolved in any number of ways. see appendix (suggesting joint doj/oig guidance as a potential pathway). 93. see supra section iii. 94. see supra note 12 and accompanying text. for the prospect that the incentive of the commission alone might lead to other abuses, see supra note 29 (discussing the ubiquity of device industry compliance practices) and infra note 100 (exploring the utility of oig’s existing “suspect characteristics” analysis). 2025] right-sizing inflation 57 inflated language, the judicial decisions track the oig’s guidance and this result. moreover, despite the dicta in some opinions, all of the commission enforcement cases finding a violation include facts that show that persons or entities receiving payments were not a “legitimate agent employed in a traditional manner to sell a product,” but instead were in a position to exert “undue influence” on the treatment decision, most frequently on the patient.95 cases have found “undue influence” when sales-based payments for sales/marketing activities are made to physicians and other health care professionals and their employees, 96 to so-called “recruiters” who actually have formed some close and influential relationship with the patient, 97 to a board member exercising influence over the ceo, 98 and in cases, especially dme cases, involving direct sale to beneficiaries. 99 and yet, inflation in the language represented in this growing body of case law suggests otherwise. so what, if anything, is to be done about the independent sales agent commission issue? on the one hand, one would hope that there is little reason to think that responsible oig or doj enforcement authorities will bring, or join, aks cases based simply on a percentage commission to an independent sales agent, without other suspect facts. nothing in the authorities discussed above— whether oig’s guidance, the holdings of the opinions, or the facts underlying ————————————————————————————— 95. see supra section iv. although its rhetoric about commissions as kickbacks is among the more extreme examples—and more evidence that corrective guidance from doj and oig is called for—the recent decision in u.s. ex rel. lutz v. mallory, 988 f.3d 730 (4th cir. 2021), is not to the contrary. in that case, the sales agents not only received commissions but used the laboratory’s payments of p&h fees to the physicians—which were also found to be unlawful kickbacks—as inducements to the physicians. see mallory, 988 f. 3d at 735-36. the aks convictions of the sales agents thus may be understood to have been as much for the agents offering or paying kickbacks to the doctors, as for receiving commissions, or alternatively, as empowering the sales agents with “undue influence” in the form of the payments to the doctors. 96. see united states v. krikheli, no. 09-cr-725, 2009 wl 4110306 (e.d.n.y. nov. 24, 2009), aff’d, 461 f. app’x 7 (2d cir. 2012) (physicians, personally or through intermediaries, arranged for patients to be referred to a radiological testing facility in exchange for payments to referring doctors); united states v. medoc health servs., llc, 470 f. supp. 3d 638, 645 (n.d. tex. 2020) (physicians were made owners of management services organizations for pharmacies and received “profits” based on their referrals to those pharmacies); united states ex rel. lutz v. mallory, 988 f.3d 730, 735, 739-40 (4th cir. 2021). see also sources cited supra note 74 and accompanying text. 97. see united states v. shoemaker, 746 f.3d 614 (5th cir. 2014). 98. see united states v. miles, 360 f.3d 472, 479-81 (5th cir. 2004). see also 56 fed. reg. at 35974; u.s. dep’t of health & hum. servs., off. of inspector gen., advisory op. no. 99-03, supra note 31, at 4-5 (noting the broad potential application of the anti-kickback statute to sales agents). 99. see united states v. shoemaker, 746 f.3d 614, 629 (5th cir. 2014); united states v. gibson, 875 f.3d 179, 190-91 (5th cir. 2017); united states v. ricard, 922 f.3d 639, 641 (5th cir. 2019); united states v. george, 900 f.3d 405 (7th cir. 2018), aff’g 171 f. supp. 3d 810, 815 (n.d. ill. 2016); united states v. williams, 218 f. supp. 3d 730, 738-39 (n.d. ill. 2016); united states v. adebimpe, 649 f. app’x 449, 455 (9th cir. 2016). see also off. of inspector gen., advisory op. no. 99-08, supra note 21; off. of inspector gen., advisory op. no. 99-10, supra note 5 and accompanying text. indiana health law review [vol. 22:27 58 the settlements—suggests that would be a well-founded action, nor one consistent with decades of experience under the aks. on the other hand, the existing state of the law and guidance—including oig’s continuing guidance stating that virtually every independent commission may be “at least [a] technical violation” 100 of the aks—coupled with the dicta quoted in too many of the more recent aks enforcement cases, gives the government, or a qui tam relator, an unfair advantage in commission cases: a free pass beyond a motion to dismiss. moreover, at trial, instead of needing to prove the presence of “undue influence,” the government may be able to count on a jury instruction advising that is not an element of the offense. and where sufficient government-funded healthcare is present, fca relators (or their counsel) may be incented to proceed. prudent allocation of government enforcement and industry compliance resources dictates that medical device makers who daily provide medically necessary products for patient diagnosis and treatment, and often are not large enterprises with the resources to fully employ a sales force 101—should not have to live with that risk. in sum, oig and doj should provide clear guidance to the medical products community that articulates the principles set forth in oig’s advisory opinions and in the actual facts of aks enforcement cases. such guidance should preclude the possibility of sales-based commission arrangements resulting in aks enforcement (or conviction), without a demonstrable presence of undue influence on a relevant decisionmaker, or some other combination of aggravating suspect characteristics at least as severe as those that have been present in the adverse decisional law discussed. the appendix sets forth proposed joint doj/oig enforcement guidelines that would incorporate the principles recognized in oig’s guidance and in judicial precedent. it is true that this is not a perfect solution, because joint agency guidance will not be binding on courts, or on fca qui tam relators. however, in the absence of statutory reform—unlikely because there is always bipartisan antagonism for anything that, however unjustifiably, could be characterized as soft on “waste, fraud and abuse”—there seems no way to force these changes. but in the interests of not allowing the perfect to be the enemy of the good, it is ————————————————————————————— 100. see, e.g., 56 fed. reg. at 35974; u.s. dep’t of health & hum. servs., off. of inspector gen., advisory op. no. 99-03, supra note 31, at 4-5 (noting the broad potential application of the anti-kickback statute to sales agents). 101. see supra note 3 (discussing the dominance of small, entrepreneurial companies in medical device innovation and the reliance on independent sales agents); supra note 6 (noting the dual role of device reps as sales agents and advisors, with practices extending globally); supra note 28 (highlighting the aks employment exception and contrasting the pharmaceutical and medical device industries' sales models). 2025] right-sizing inflation 59 to be hoped that the weight of agency interpretation, bolstered by the analysis set forth in this article, will also lead courts to dismiss from fca cases counts that are based on no more than “a legitimate payment to a legitimate agent employed in a traditional manner to sell a product.”102 ————————————————————————————— 102. see supra note 22 (highlighting rep. rostenkowski's statement on conventional sales agents). to be sure, there is always a risk of misbehavior by the sales agents themselves. they could pay kickbacks to the ordering professionals or providers or otherwise find ways to exercise “undue influence.” that appears to be the underlying rationale for the mallory decision, see u.s. ex rel. lutz v. mallory, 988 f.3d 730 (4th cir. 2021). but that is precisely why the oig has identified “suspect characteristics” to guide enforcement. see medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. at 35954. see also supra note 45 (noting the oig's analysis of suspect characteristics and undue influence in marketing arrangements); see supra notes 46-49 (providing examples of oig advisory opinions related to marketing practices and vulnerable populations); see also supra notes 50-53 (analyzing characteristics typically absent in medical device sales except in dmepos cases). there is no reason to think that the industry’s compliance apparatus would be any less effective if enforcement were limited to cases involving those “suspect characteristics.” see supra note 29. appendix proposed doj/oig enforcement guidelines joint doj/oig guidelines for initiating enforcement proceedings under the federal health care programs (“fhcp”) anti-kickback statute (“aks”) for payment of commissions to independent sales agents of medical devices. the aks 103 is criminal statute prohibiting the offer, payment, solicitation or receipt of any remuneration for, among other things arranging for or recommending the purchase, order or lease of any item or service for which payment may be made under a fhcp. the department of justice (“doj”) has responsibility for criminal enforcement, and the department of health and human services office of inspector general (“oig”) has responsibility for enforcement of various administrative sanctions, including civil monetary penalties and exclusion from fhcp participation. because aks cases are often brought under the false claims act (“fca”), doj also has responsibility for aks enforcement in those cases as well. under current law, questions may be raised as to whether the statute is implicated when a maker of medical devices pays an independent sales agent for promoting (by hypothesis, “arranging for or recommending”) the sale of a product that may be used in the diagnosis or treatment of a fhcp patient. the personal services “safe harbor” may be available for certain such arrangements, but may not be available for traditional commission-type payments: compensation that is based directly or indirectly on the amount of product sold. oig is aware that in many sectors of the medical device industry, such compensation is the norm and, accordingly, has consistently advised that, such arrangements generally merit enforcement only when certain “suspect characteristics” are present. oig’s analysis of recent judicial opinions in aks cases supports the conclusion that doj is cognizant of these characteristics in exercising prosecutorial discretion over which cases to bring, including which relator-initiated false claims act cases to join. however, obiter dicta in more than one judicial opinion rendered in such cases seems to equate all commission-type arrangements with kickbacks. oig and doj are concerned that such language may encourage prosecutions or fca cases in circumstances where suspect characteristics are not present, that do not warrant the use of federal resources in enforcement, and that do not, in fact, involve violations of the aks. for this reason, oig and doj have jointly adopted these guidelines, to encourage aks enforcement against payment or receipt of commission-type payments to independent sales agents of medical devices only in circumstances where the totality of the circumstances show that enforcement is necessary to prevent patient or fhcp abuse, which may be the case when there is strong evidence that one or more of the following suspect characteristics is present. 1. nature of the sales agent a. undue influence. use of sales agents who are health professionals or ————————————————————————————— 103. social security act § 1128b(b) (codified at 42 u.s.c. § 1320a-7b(1)(b) (2010)). 2025] right-sizing inflation 59 persons in a similar position to exert undue influence on purchasers or patients. i. commentary: along with targeting a vulnerable audience (see #2 below), this is one of the two most important factors. ordinary sales agents, whose only relationship with the person ordering or purchasing is that of an independent promoter of the product, generally should not be in a position to exercise any “undue influence.” most of the cases in which aks commission convictions have been upheld have involved persons who are in a position to exercise “undue influence.” 104 in addition to health care professionals (hcps) (when communicating with patients), “undue influence” has been found where the person receiving the remuneration is in a position of authority over, or is effectively, the decisionmaker, 105 and where the recipient of the commission has used deception, bribes or gifts to influence a healthcare professional or beneficiary. 106 2. nature of the audience a. targeted to the vulnerable. is the sales/marketing activity specifically directed at senior citizens, medicaid beneficiaries, or other particularly vulnerable populations. i. commentary: neither oig’s advisory opinions nor the reported cases cite this factor except in its absence, e.g., oig gave ————————————————————————————— 104. see, e.g., united states v. shoemaker, 746 f.3d 614, 627-29 (5th cir. 2014) (presenting an “archetypal example of the undue influence prohibited by the [aks:]” payments to board chair of local hospital, not to distribute a brochure about the nursing company to hospital staff or engage in any form of traditional marketing, but rather to exploit his relationships with hospital executives to steer business towards the company). 105. see, e.g., united states v. miles, 360 f.3d 472, 480-81 (5th cir. 2004) (“[b]ecause the salesman in polin was the relevant decisionmaker and his judgment was shown to have been improperly influenced by the payments he received from the monitoring service, the seventh circuit [in polin] correctly upheld the conviction of the individuals who paid the salesman.”), (citing with approval united states v. polin, 194 f.3d 863, 866 (7th cir. 1999) (“once it was decided that the patient would be sent to an outside service for monitoring, [the sales representative] would suggest [defendants] or a similar service to the physician. never in his fourteen-year career was [the sales representative's] suggestion rebuked by a physician. indeed, after his recommendation was made, he would call [the monitoring service] and arrange for the patient's follow-up himself. of course, [the monitoring service] would have to receive the physician's authorization before commencing service, but that permission seemed to be more of a formality or rubber stamping of [the sales representative's] referral.”). see also united states v. vernon, 723 f.3d 1234, 1254 (11th cir. 2013) (noting that “patient advocate” was “effectively responsible for deciding which pharmacy to use for the filling of patients’ prescriptions”). 106. see, e.g., off. of inspector gen., advisory op. no. 98-1, (mar. 19, 1998) (free inventory of loaner products to referring physicians); united states v. turner, 561 f. app’x 312, 316-17 (5th cir. 2014) (telemarketers falsely informed beneficiaries that they were entitled to free arthritis kits, and did not collect the twenty percent co-insurance for dme supplies, potentially also in violation of the prohibition on dme telemarketing). indiana health law review [vol. 21:27 60 favorable treatment to an advertising campaign by podiatrists in a shoe store because although there would be contact with fhcp beneficiaries, the store sold to all kinds of customers and beneficiaries therefore were not a special target. 107 b. contact with the vulnerable. direct contact between the sales agent and fhcp beneficiaries prior to the delivery or dispensing of the product. i. commentary: as noted immediately above, oig has given favorable advisory opinion treatment where there was contact with medicare beneficiaries when those beneficiaries were not the exclusive or even primary targets of the sales activity. 108 however, most cases of suspect commission sales activity have been found in situations where sales/marketing activity was directed at patients, who are deemed not to be sophisticated purchasers, and to be particularly “vulnerable” to aggressive sales tactics.109 it is important to note that the danger is of inappropriate sales/marketing activity. where the sales agent’s role is limited to fitting or training of a device that has already been prescribed and dispensed prior to the agent’s appearance, this generally should not be an issue. c. physicians and other hcps. direct contact between the sales agent and physicians in a position to order items or services that are then paid for by a fhcp i. commentary: although this factor may be considered, it would be the unusual case where contact itself with physicians or other product decisionmakers by independent sales agents represents an abusive situation. subsequent oig guidance recognizes that, in general, physicians and other health care professionals “such as dme suppliers, physicians, and respiratory therapists” are “a less vulnerable audience” than patient customers. 110 ————————————————————————————— 107. off. of inspector gen., advisory op. no. 99-08, (july 6, 1999) (finding that a suspect characteristic is present if “the activity is specifically directed at senior citizens, medicaid beneficiaries, or other particularly vulnerable populations,” but approving marketing arrangement that, “while it involves direct patient contact, the arrangement is not targeted at federal health care program beneficiaries.”). 108. see medicare and state health care programs: fraud and abuse; oig anti-kickback provisions, 56 fed. reg. 35952, 35974 (jul. 19, 1991) (to be codified at 42 c.f.r. pt. 1001). cf. u.s. dep’t of health & hum. servs., off. of inspector gen., advisory op. no. 98-10 (aug. 31, 1998) (discussing the approval of a low risk of fraud and abuse commission arrangement that “would technically fall within the prohibition of the anti-kickback statute if the requisite intent were present”). 109. see, e.g., united states v. turner, 561 f. app’x 312, 316-17 (5th cir. 2014) (defendant “used . . . teenagers . . . to solicit medicare beneficiaries by telephone, then used information gathered during those calls to bill . . .”). 110. see, e.g., off. of inspector gen., advisory opinion no. 98-10, supra note 5 (“there was no contact between sales agent a and patients or physicians. [he] was not in a position to 2025] right-sizing inflation 61 3. nature of the activity a. coercive. the nature of the marketing or promotional activity, the degree to which it may be coercive, or perceived to be coercive. 111 i. commentary: for marketing by independent sales agents to hcps, this should rarely be an issue. with respect to consumers, door-to-door marketing, telephone solicitations, and direct mailings are more intrusive, and typically pose a greater potential for abuse than truthful passive advertising in general circulation newspapers or on television. 4. nature of the device a. direct billing of a fhcp by the seller for the item or service sold by the sales agent. i. commentary: for medical devices, this is rarely the case in medicare except for items paid for under the durable medical equipment, prosthetics or orthotics (dmepos) benefit. dmepos also often involve direct contact with patients, who are recognized to be “vulnerable” to inappropriate sales/marketing activity. direct billing thus generally should not be an issue absent this connection of the sales agent to vulnerable patients, and again, excluding situations where the product has already been prescribed and dispensed. b. marketing of items or services that are separately reimbursable by a fhcp (e.g., items or services not bundled with other items or services covered by a drg payment), whether on the basis of charges or costs. i. commentary: as noted, except for dmepos (and certain passthrough devices) this is rarely the case for medical devices. like billed by the seller, for dmepos, separately reimbursable should be connected with inappropriate/coercive sales/marketing activity to the beneficiary in order to deserve scrutiny. c. whether the item or service is one for which there is a likelihood of over-utilization based on the historical experience of fhcps, reimbursement methodology, or other reason. ————————————————————————————— exert undue influence on medical decision-making . . . [and his] direct contacts were sophisticated purchasers, either [gpos] or . . . multi-hospital systems . . .”). 111. see, e.g., off. of inspector gen., advisory op. no. 99-08, supra note 21 (“one relevant factor is whether and to what degree the activity may be . . . perceived to be coercive by the party to whom the activity is directed. for example, door-to-door marketing, telephone solicitations, and direct mailings [to beneficiaries] are more intrusive, and typically pose a greater potential for abuse, than truthful passive advertising in general circulation newspapers or television.”). indiana health law review [vol. 21:27 62 i. commentary: this factor has been mentioned, but never found to be present in a commission advisory opinion. in other noncommission cases, diagnostics and other nonor minimallyinvasive services have been noted as most subject to overutilization.112 ************* ————————————————————————————— 112. see, e.g., u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 12-10 (aug. 30, 2012) (noting that advanced imaging services may be subject to over-utilization); u.s. dep’t health & hum. servs., off. of inspector gen., advisory op. no. 11-15 (oct. 3, 2011) (profit distributions to physician investors in laboratory business pose “considerable risks of overutilization”); u.s. gov’t accountability off., gao-12-966, higher use of advanced imaging services by providers who self-refer costing medicare millions (2012). structure bookmarks ightsizing nflation in ntiickback aw hetoricvoiding nnecessary arket istortion in ommissions on edical evice ales indiana health law review volume xx 2023 number 1 notes defending disabilities: how indiana should approach adjudication and punishment of individuals with intellectual disabilities in sexual crimes evan golightly* i. introduction late on a winter night, a young man named raymond garnett stopped by a friend’s house to ask for a ride home.1 his friend, erica frazier, heard him outside and opened her bedroom window.2 instead of giving raymond a ride, erica invited him to come into her bedroom, so he climbed through the window.3 erica and raymond conversed and then engaged in voluntary sexual intercourse.4 when this encounter occurred, raymond was twenty years old, and erica was thirteen.5 raymond has down syndrome and his iq level is fifty-two.6 raymond’s guidance counselor at school indicated that his reading skills are at the level of a third-grade child, and his social skills are on par with children who are eleven or twelve years old.7 his counselor further indicated that raymond attended special education classes and, at one point, received education at home to avoid social taunting from his peers.8 raymond’s disability affected him to the point that he could not understand assigned duties, and as a result, his attempts to complete vocational work failed.9 when he was attempting to work, raymond * j.d. candidate, 2023, indiana university robert h. mckinney school of law; b.a., 2020, ball state university. 1. garnett v. state, 632 a.2d 797, 799 (md. 1993). 2. id. 3. id. 4. id. 5. russel christopher & kathryn christopher, the paradox of statutory rape, 87 ind. l.j. 505, 511 (2012) (citing garnett, 632 a.2d at 799). 6. id. at 510 (citing garnett, 632 a.2d at 798). 7. garnett, 632 a.2d at 798. 8. id. 9. id. at 799. 92 indiana health law review [vol. 20:91 frequently lost his way trying to return home from work.10 unfortunately, raymond failed the state’s functional tests required for graduation, so he could not earn a diploma and had to settle for a certificate of completion in school.11 when raymond first encountered erica, she told raymond that she was sixteen years old.12 erica had several friends who reinforced this false reality in raymond’s mind.13 because raymond’s classmates at school abused him so much, he probably found solace when he thought he found a friend in erica. however, after the sexual encounter occurred between them, raymond was charged with second degree rape under maryland law based on the age disparity, raymond being four years older than erica and her being younger than fourteen.14 the applicable rape statute in this case imposed strict liability; no consideration could be given to raymond’s mental state or his disability.15 the maryland statute read that a person is guilty of second degree rape if the person has vaginal intercourse with someone, “[w]ho is under fourteen years of age and the person performing the act is at least four years older than the victim.”16 someone found guilty under this statute was thus labeled a rapist and faced a potential twenty-year prison sentence.17 raymond’s disability likely prohibited him from understanding that his actions could lead to such a serious penalty. although the maryland court of appeals sentenced raymond to five years of probation, the court affirmed his conviction, marking raymond with the stigma that comes with being a felon and a rapist.18 based on the wording in the statute, the prosecution needed to prove only that raymond had sex with erica while an age disparity existed to convict raymond of the crime of statutory rape. since the maryland statute did not permit a defendant to argue that he or she made a mistake regarding the victim’s age, raymond could not defend against the charges by explaining how his disability made him more susceptible to being deceived and more disposed to believe what his friends had told him. indeed, his guidance counselor had stated that he functioned socially as a child between the ages of eleven and twelve.19 the court even mentioned in its opinion that, “[a]rguably, had raymond’s chronological age, 20, matched his socio-intellectual age, about 12, he and erica would have fallen well within the four-year age difference obviating a violation of the statute, and raymond would not have been charged with any crime at all.”20 10. id. 11. id. 12. id. 13. id. 14. id. 15. id.; see strict liability, black’s law dictionary (11th ed. 2019). 16. md. code ann. art. 27, § 463 (1957, 1992 repl. vol.). 17. id. 18. garnett, 632 a.2d. at 799, 805. 19. id. at 798. 20. id. at 800. 2023] defending disabilities 93 this note argues that raymond’s case illustrates a scenario where justice was not served. the maryland statute denied raymond the ability to offer his intellectual disability as a mitigating factor in a crime that carried a high penalty. indeed, crimes which do afford any consideration to a defendant’s mental state typically carry small penalties or monetary fines.21 the statute applying to raymond, however, could impose a maximum sentence of twenty years in prison, and label him as a felon and a rapist.22 arguably, the scenario envisioned when drafting this statute involved a person who could appreciate the risks in having sex with someone who appears young and could understand the risk that the other person might misrepresent their age.23 raymond presents a foil for this scenario contemplated by legislators. indeed, based on the factual findings in the case, one could even argue that raymond is the victim. taking into account raymond’s iq level, erica’s misrepresentations that were reinforced by her friends, along with the increasing awareness about sexuality at younger ages, “there is every reason to question whether the victim was [raymond], rather than [erica].”24 raymond’s case poignantly manifests how the law can unjustly punish people who may not genuinely possess criminal intent, are not a serious threat to society, and should be afforded an alternative punishment and rehabilitation opportunities. this note focuses on providing a solution to an indiana statute that fails to properly account for individuals with intellectual disabilities. the issue in raymond’s case is not an isolated problem, but one that affects individuals with similar mental limitations. in particular, this note focuses on examining indiana’s statute governing sexual misconduct with a minor, which is essentially indiana’s equivalent to maryland’s law in the garnett case.25 indiana’s statute poses problems for individuals with intellectual disabilities that are similar to the challenges raymond faced in maryland.26 although indiana’s statute provides a mistake of age defense, the language and application of the defense to defendants with intellectual disabilities is not adequate and fails to properly assess culpability relating to people who share raymond’s disabilities.27 raymond’s case is a powerful, yet unfortunate illustration of the disproportionate punishment some statutes impose. labeling someone a felon and a rapist for a crime that they could not appreciate or understand should not be accepted by society. indiana’s statute, although different from maryland’s, fails to adequately address how to assess culpability when someone like raymond is involved. indiana’s legislature must implement wording into the statute to guard against disproportionately punishing individuals with an intellectual disability. 21. id. at 806 (eldridge, j., dissenting) (stating that such a high penalty for a strict liability crime is unusual and does not comport with typical public policy reasoning). 22. id. at 799. 23. id. at 807 (eldridge, j., dissenting). 24. id. at n.17 (bell, j., dissenting). 25. see ind. code § 35-42-4-9 (2021). 26. see generally id. 27. see ind. code § 35-42-4-9(c) (2021). 94 indiana health law review [vol. 20:91 more so, indiana should adopt alternative punishment programs that appropriately punish individuals with intellectual disabilities by focusing on rehabilitation rather than retribution. this note advocates that indiana has a duty to amend its statute governing sexual misconduct with a minor, and institute new adjudicatory and punitive procedures based off a diversion program adopted in the california penal code. defining intellectual disability is crucial to understanding how to assess an individual’s culpability. grasping the limitations and challenges faced by individuals with intellectual disabilities will reveal why indiana’s current statutory language and punishment methods are harmful to their health and wellbeing. part ii of this note firmly establishes the effects of an intellectual disability on an individual. complex sexual interactions further exacerbate the limitations and challenges individuals with intellectual disabilities grapple with daily. further, this section emphasizes the lamentable treatment these individuals face once they become involved in the criminal justice system. part iii identifies culpability as a paramount concept that shows why individuals with intellectual disabilities may face unjust punishment. this section also analyzes how indiana treats individuals with intellectual disabilities under its sexual misconduct with a minor statute. this note also analyzes multiple theories of punishment, revealing that punishing individuals with intellectual disabilities in certain contexts cannot be justified by any relevant theory. finally, this note proposes the solution that indiana should adopt a diversion program derived from or similar to the california penal code. this program provides defendants with intellectual disabilities the opportunity to receive diagnoses and treatments from health professionals and alternatives to incarceration through placement in rehabilitation centers. the diversion program would, therefore, fill the gap that exists in the indiana’s statute. part iv concludes that indiana must address the gap in its statute before it becomes a serious problem. to protect its residents, indiana has a duty to adopt a diversion program in its statute to guard against the criminal justice system’s continued abuse towards individuals with intellectual disabilities. ii. background a. establishing the significant limitations and challenges faced by individuals with intellectual disabilities defining “intellectual disability” is imperative to understanding the exact population an amendment to indiana’s sexual misconduct with a minor statute would protect.28 the latest edition of the diagnostic and statistical manual of 28. the term “mental retardation” is antiquated and no longer used by mental health professionals. “intellectual disability” is the common term used to describe some sort of cognitive limitation. however, much of the material that will be subsequently cited uses the former terminology (mental retardation). the quoted materials will be incorporated as they were at the 2023] defending disabilities 95 mental disorders (“dsm-5”) states that an intellectual disability is characterized by “deficits in general mental abilities, such as reasoning, problem solving, planning, abstract thinking, judgment, academic learning, and learning from experience.”29 these deficits in intellectual functioning naturally impair social and adaptive behavior as well.30 for instance, an individual who suffers from an intellectual disability fails to meet standards of “personal independence and social responsibility” in their daily life.31 these limitations or failures in behavioral functioning include limited communication, difficulty in social participation, lack of personal independence, and significantly below average performance in academic or occupational domains.32 several criteria must be met before affirmatively diagnosing an individual with an intellectual disability.33 generally, an intellectual disability is a disorder that manifests in an individual’s developmental stage by clear deficits in both intellectual and adaptive behavior.34 the dsm-5 lists three criteria that must be met to affirmatively diagnose an intellectual disability: (1) deficiencies in intellectual functioning must be confirmed by clinical assessment and standardized intelligence testing catered to the individual; (2) deficiencies in adaptive functioning indicating a failure to achieve developmental and sociocultural standards which limits both personal independence and an individual’s ability to practice social responsibility; and (3) onset of these deficiencies must occur during the developmental period.35 an intellectual disability, then, is a disorder that adversely affects an individual’s daily life in numerous ways. varying levels of severity exist on the spectrum of intellectual disabilities. according to the dsm-5, an intellectual disability’s severity is measured by evaluating adaptive functioning and not by iq scores.36 adaptive functioning is more helpful in assessing intellectual disabilities because it more accurately identifies the support levels an individual requires, whereas iq levels can be skewed by additional disabilities and are typically less reliable in the lower range time they were written, but for consistency’s sake, “intellectual disability” will be the prevailing term used to address the issue this note focuses on. 29. am. psychiatric ass’n, diagnostic and stat. manual of mental disorders 31, (5th ed. 2013). first published in 1952, the dsm is widely considered by the health care community as an authoritative guide to understanding and diagnosing mental disorders. the dsm is in its fifth iteration. see dsm-5: frequently asked questions, am. psychiatric ass’n, https://www. psychiatry.org/psychiatrists/practice/dsm/feedback-and-questions/frequently-asked-questions [https://perma.cc/9zv4-t39e] (last visited feb. 10, 2022). 30. diagnostic and stat. manual of mental disorders, supra note 29. 31. id. 32. id. 33. id. 34. id. at 33. 35. id. 36. id. 96 indiana health law review [vol. 20:91 of iq scores.37 moreover, comorbidity is a significant factor that skews iq results from accurately reflecting an individual’s levels of intellectual and adaptive functioning.38 the centers for disease control and prevention define comorbidity as a situation where multiple diseases or conditions exist simultaneously within the same person.39 therefore, “clinical training and judgment are required to interpret test results and assess intellectual performance.”40 the dsm-5 contains graphic tables that illustrate and explain the four intellectual disabilities categories: mild, moderate, severe, and profound.41 these tables describe how individuals who fall into these categories function in the conceptual, social, and practical domains.42 for this note’s purposes, the focus will be specifically on individuals who suffer from a moderate intellectual disability.43 a moderate intellectual disability affects an individual’s development in the conceptual domain such that conceptual skills “lag markedly behind those of peers.”44 indeed, this developmental impediment has lasting effects into adulthood. for an adult who possesses a moderate intellectual disability, academic skill is typically equivalent to a child in elementary school.45 the dsm5 states that ongoing assistance is required to help these individuals complete conceptual tasks in their daily life and even suggests that more competent family members or caretakers assume these responsibilities completely for the individual.46 in the social domain, a moderate intellectual disability impedes the individual’s ability to properly interact with others and understand social skills.47 despite these impediments, individuals can still form and maintain friendships, and even experience romantic relationships in adulthood.48 however, significant 37. id. 38. id. at 37. 39. comorbidities, ctr. disease control & prevention, https://www.cdc.gov/arthritis/ data_statistics/comorbidities.htm [https://perma.cc/egg5-kq44] (last updated may 17, 2019). 40. diagnostic and stat. manual of mental disorders, supra note 29, at 37. 41. id. at 33. 42. id. at 35. 43. moderate disabilities impose greater challenges on individuals than mild disabilities, but not as serious challenges as severe or profound disabilities. this note focuses on the moderate category because it seems to be the “lowest” level that needs protection in statutes. since severe and profound disabilities impose even greater limitations on adaptive and intellectual functioning, it follows that statutory amendments would apply to people who possess severe or profound levels of intellectual disabilities. 44. diagnostic and stat. manual of mental disorders, supra note 29, at 35. 45. id. 46. id. 47. what is intellectual disability?, am. psychiatric ass’n (aug. 2021), https://www. psychiatry.org/pat ien ts-families/intellectual-disability/what-is-intellectual-disability [https://perma.cc/g3nd-rref]. 48. diagnostic and stat. manual of mental disorders, supra note 29, at 35. 2023] defending disabilities 97 obstacles are present when an individual may be forming these relationships. individuals who possess a moderate intellectual disability may not accurately interpret a social cue (such as consent) or may even fail to perceive a social cue altogether.49 the dsm-5 states that, “social judgement and decision-making abilities are limited, and caretakers must assist the person with life decisions.”50 raymond’s story poignantly captures this point, demonstrating that limited social judgment clearly poses significant challenges for individuals navigating daily life and its vicissitudes.51 since the dsm-5 suggests that individuals with an intellectual disability require assistance in very basic daily tasks, it follows that more complex tasks such as interpersonal interactions are even more difficult for such individuals. b. sexual interactions: another layer of difficulty in adaptive functioning human experience has shown very clearly that relationships can be difficult. whether it be political disagreements, struggles between social classes, or simply personalities which are at variance with one another; human beings face challenges in their social interactions every day. consequently, navigating interactions with others can require a certain level of self-awareness regarding the context in which someone might find themselves. for an individual with an intellectual disability, adapting to complex social interactions and situations is significantly hindered.52 indeed, moderate intellectual disabilities impose difficulties associated with, “social judgment; assessment of risk; selfmanagement of behavior, emotions, or interpersonal relationships.”53 sexual interactions add another layer of emotional, physical, and psychological complexity to human interactions.54 agustín fuentes is a professor at princeton university who holds a ph.d. in anthropology from the university of california, berkeley, and wrote that sex is a “seriously complicated” act.55 this complexity is played out in what fuentes calls “a series of events and negotiations with hard to predict results.”56 within this complex framework of socio-sexual interaction, fuentes elaborates that humans inevitably carry with them a host of personal characteristics and experiences into every potential sexual encounter.57 these characteristics and personal elements include an individual’s exposure to 49. id. 50. id. 51. garnett, 632 a.2d. at 799. 52. diagnostic and stat. manual of mental disorders, supra note 29, at 35. 53. id. at 38. 54. see agustín fuentes, why is sex so complicated, psych. today (dec. 3, 2012), https://www.psychologytoday.com/us/blog/busting-myths-about-human-nature/201212/why-is-sexso-complicated [https://perma.cc/ylt4-vusq] (explaining why basic and natural sexual interactions are so complex). 55. id. 56. id. 57. id. 98 indiana health law review [vol. 20:91 and understanding of sexual interactions, as well as factors such as age.58 indeed, fuentes emphasizes that sexuality is a central part of human nature that influences “social intercourse,” and the mutual “exchanges of thoughts and feelings.”59 much to their detriment, individuals with intellectual disabilities face unique challenges that can lead to harmful sexual experiences, both for themselves and for others. on a natural level, research indicates that sex drive in individuals with intellectual disabilities is just as powerful as the sex drive in their peers.60 additionally, people with intellectual disabilities frequently receive no formal sexual education.61 indeed, this insulation from sexuality leads to individuals with intellectual disabilities failing to acquire social skills and a “fear of and inexperience with independence.”62 even more, a person with an intellectual disability frequently lacks a peer group and is limited to interactions with younger children, thus seizing from them the opportunity to learn about appropriate sexual behavior which “makes it more likely that all of his social interactions, including sexual ones, will be with his intellectual and social peers who may be significantly younger.”63 the complex nature of sexual interactions is difficult for an individual like raymond to grasp, which led to his unfortunate statutory rape conviction. raymond’s case is disheartening because there is every reason to question whether raymond was the victim as opposed to the criminal in this case.64 considering raymond’s disability and erica’s misrepresentation about her age—which was further reinforced to raymond by erica’s friends—one can conclude that raymond’s naiveté and difficulty understanding social and sexual behavior caused him to be deceived. without training, education, and ageappropriate exposure to sex, individuals with intellectual disabilities are more likely to act impulsively.65 it leaves individuals like raymond more susceptible to being misled, deceived, and exploited by people like erica. this vulnerability can have severe impacts on an individual’s life, evidenced by raymond being forced to carry the “felon” and “rapist” stigmas for the rest of his life. 58. id. 59. id. 60. elizabeth nevins-saunders, incomprehensible crimes: defendants with mental retardation charged with statutory rape, 85 n.y.u. l. rev. 1067, 1094 n.124 (2010) (citing john f. simonds, sexual behaviors in retarded children and adolescents, 1 j. dev. & behav. pediatrics 173, 175 (1980)). 61. id. at 1094. 62. id. at 1095. 63. id. at 1095-96. 64. garnett v. state, 632 a.2d 797, 816 n.17 (md. 1993) (bell, j., dissenting). 65. sex and intellectual disabilities, am. psych. ass’n (dec. 2017), https://www.apa.org/ monitor/2017/12/seeking-intimacy-sidebar [https://perma.cc/4f52-ulpk]. 2023] defending disabilities 99 c. into the depths: prevailing problems for individuals with intellectual disabilities in the criminal justice system individuals with intellectual disabilities are not only mistreated by poorly written laws, but their plight continues in the abuse they receive from the criminal justice system.66 additionally, raymond’s case is not an isolated instance, for many individuals like him encounter unfair treatment that extends beyond simple mens rea or strict liability.67 individuals with intellectual disabilities suffer abuse and injustice from the very moment they encounter law enforcement to their subsequent hearings, adjudication, and sentencing.68 the challenges for people like raymond, therefore, permeate every phase of the criminal justice system. before they even commit a crime, individuals with intellectual disabilities are frequently more predisposed towards criminal activity.69 children with intellectual disabilities are 3.4 times more likely to be abused than children without disabilities; this abuse contributes to higher crime rates by individuals with disabilities because many people who were abused sexually in childhood become sexual offenders later in life.70 indeed, the unfortunate reality is that “their experience as victims [is] linked to their later experience as offenders.”71 these individuals not only suffer from increased likelihood of crime on a personal level, but they are also more vulnerable to being manipulated.72 individuals with disabilities are “frequently used by other criminals to assist in law-breaking activities without understanding their involvement in a crime or the consequences of their involvement.”73 a common need and desire to feel accepted by others compounds their vulnerability which, in turn, often makes them agree to engage in criminal actions simply to cultivate friendships.74 even when these individuals are not involved in criminal action, they are more likely to arouse suspicion among law enforcement.75 a primary way they engender suspicion is by unintentionally acting or responding to police officers in a way that can be easily misunderstood.76 for instance, ethan saylor, a twentysix-year-old man with down syndrome died from asphyxiation caused by police 66. see generally leigh ann davis, people with intellectual disabilities in the criminal justice system: victims & suspects, arc 1, 1 (june 2005), https://www.uwgb.edu/uwgbcms/ media/bhtp/files/arc_dd_and_cj.pdf [https://perma.cc/km4g-wgbs]. 67. see mens rea, black’s law dictionary (11th ed. 2019). 68. see generally id.; see also robert perske, false confessions from 53 persons with intellectual disabilities: the list keeps growing, 46 intell. & developmental disabilities 468, 468-479 (2008). 69. davis, supra note 66, at 1. 70. id. 71. id. 72. id. at 2. 73. id. 74. id. 75. id. 76. id. 100 indiana health law review [vol. 20:91 officers when they tried to arrest him.77 saylor had just seen a movie with his caretaker when, after briefly exiting the theater, he decided he wanted to watch the movie again.78 saylor’s mistake was that he failed to purchase a ticket for the second viewing.79after having the police called on him, saylor was not cooperating and became extremely agitated when the officers tried to restrain him, even though his caretaker pleaded with the officers to let her handle the situation.80 the officers used excessive force to subdue saylor because, as his caretaker tried to explain, saylor became severely panicky and uncooperative when touched.81 tragically, the officers took saylor to the ground and fractured cartilage in his larynx which caused him to suffocate.82 a simple miscommunication and lack of understanding by the officers resulted in his unnecessary death. a key factor leading to lamentable stories like saylor’s is that, once individuals with intellectual disabilities encounter law enforcement, they typically default to certain behaviors.83 these behaviors include trying to cover up their disability or not understanding their rights—even though they pretend to understand them—often because they are overwhelmed.84 unfortunately, these natural reactions exacerbate issues with police officers and lead to further injustice. once they feel overwhelmed, these individuals tend to react hastily, rashly, and impulsively in the presence of police.85 more often than not, individuals with intellectual disabilities simply say what the officers want to hear or even confess to a crime they did not commit out of confusion.86 corinthian bell, a man diagnosed as “mentally retarded,” was accused of murdering his own mother.87 after enduring over fifty hours of questioning by law enforcement, bell finally confessed to the murder.88 however, dna evidence exonerated bell and proved that another person was responsible.89 by the time this evidence was produced, bell had already spent seventeen months in jail.90 therefore, individuals with intellectual disabilities are susceptible to coercion, vulnerable to exploitation, and are made to suffer for their own difficulties in 77. david m. perry, justice for down syndrome man who died in movie theater, cnn (aug. 29, 2013, 12:24 pm), https://www.cnn.com/2013/08/29/opinion/perry-down-syndromedeath/index.html [https://perma.cc/t9et-gu5t]. 78. id. 79. id. 80. id. 81. id. 82. id. 83. davis, supra note 66, at 2. 84. id. 85. id. 86. id. 87. perske, supra note 68, at 469. 88. id. 89. id. 90. id. 2023] defending disabilities 101 understanding. through no real fault of their own, individuals with intellectual disabilities can be the unfortunate catalyst of their own arrest. once individuals with intellectual disabilities become involved in the criminal justice system, “[t]hese individuals are less likely to receive probation or parole and tend to serve longer sentences due to an inability to understand or adapt to prison rules.”91 additionally, once in prison, individuals with intellectual disabilities are at a greater risk for being exploited and abused by both prison staff and their fellow prisoners.92 if an individual with an intellectual disability fails to understand an order, he or she is often “physically forced to comply.”93 one man recounted an instance where he saw a fellow prisoner with mental health needs being thrown into a shower because the man failed to bathe when instructed.94 an individual’s inability to grasp protocols or instructions due to difficulty processing information or anxiety can even lead to a disciplinary report.95 in turn, these reports may then result in prolonged sentences or even solitary confinement.96 even more, solitary confinement has been shown to exacerbate intellectual disabilities.97 the bleak reality is that these vulnerable individuals encounter severe threats to their personal health and safety at every stage throughout their sojourn in the criminal justice system. individuals with intellectual disabilities are simply more vulnerable to all the negative effects of the criminal justice system. whether it be engendering police suspicion or not understanding their rights, these individuals need a safety net and legal protection. indeed, even when justly convicted, these individuals are significantly more likely to suffer abuse and exploitation in prison. indiana has not had to face this issue very often; however, the legislature has a duty to protect indiana residents and must make changes before any major issues arise. indiana stands in a position where it can enact more circumspect legislation, and provide alternatives to traditional incarceration before the abuse becomes even more prevalent among individuals with intellectual disabilities. 91. davis, supra note 66, at 2. 92. jennifer sarrett, u.s. prisons hold more than 550,000 people with intellectual disabilities—they face exploitation, harsh treatment, conversation (may 7, 2021, 8:44 am), https://theconversation.com/us-prisons-hold-more-than-550-000-people-with-intellectualdisabilities-they-face-exploitation-harsh-treatment-158407 [https://perma.cc/c5r8-8wz3]. 93. id. 94. id. 95. jennifer sarrett & alexa ucar, beliefs about and perspectives of the criminal justice system of people with intellectual and developmental disabilities: a qualitative study, 3 soc. sci. & human. open 1, 2 (2021). 96. id. 97. sarrett, supra note 92. 102 indiana health law review [vol. 20:91 iii. analysis a. culpability: the core factor in assessing guilt to protect individuals with intellectual disabilities from unjust punishment, laws must be shaped to accurately assess an individual’s fault. the age-old axiom, “[l]et the punishment fit the crime,” drives right at the idea of culpability. culpability is the foundation that undergirds criminal liability, for it is the conceptual term used to describe an individual’s “moral blameworthiness.”98 the concept of culpability hearkens back to what has been the “criminal law’s mantra” for hundreds of years: “actus non facit reum nisi mens sit rea.”99 this timeless axiom translates to: “[a]n act does not make [the doer of it] guilty, unless the mind be guilty.”100 in practice, someone is not criminally culpable unless the government proves both the “actus reus” and the “mens rea” of a crime.101 the mens rea of a crime is especially important when crafting legislation that will take intellectual disabilities into consideration. as raymond’s case demonstrated, the issue raised on appeal was not whether raymond performed the criminal act, but the extent to which raymond’s disability immunized him from culpability.102 therefore, equitably prosecuting and punishing individuals with intellectual disabilities rests heavily on a statute’s mens rea requirement. the term mens rea is defined as, “he state of mind that that the prosecution, to secure a conviction, must prove that the defendant had when committing a crime.”103 so, mens rea is distinct from the specific criminal action a defendant performs and strictly addresses the defendant’s mental disposition. although mens rea has elicited some confusion as to its precise meaning, the term has essentially split into a broad definition and a narrower definition.104 the broader definition describes mens rea as synonymous with personal blameworthiness; that is, the conditions pertaining to the criminal actor’s mental state at the time that he or she is committing the crime.105 this broad construction of mens rea reflects a somewhat subjective-leaning evaluation of culpability that, inevitably, is subject to ambiguity. the narrower definition attempts to limit the conception of mens rea to the mental elements prescribed by a statute.106 while the former is more 98. culpability, black’s law dictionary (11th ed. 2019). 99. joshua dressler & stephen garvey, criminal law: cases and materials 157 (8th ed. 2019). 100. id. 101. joshua dressler, understanding criminal law 117 (7th ed. 2015). see dressler & garvey, supra note 99 (for a discussion of actus reus). in rare cases, some crimes involve strict liability, see strict liability, black’s law dictionary (11th ed. 2019). 102. garnett, 632 a.2d at 800. 103. mens rea, black’s law dictionary (11th ed. 2019). 104. paul h. robinson, mens rea, encyclopedia of crime & justice 995, 995-96 (joshua dressler ed., 2d ed., 2002). 105. id. 106. id. 2023] defending disabilities 103 concerned with the mental state from a moral perspective, the latter perspective is more positivist.107 one need not ascribe to either the broad or the narrow definition of mens rea to understand the rational underpinnings of its utility. the reason for adding a mens rea requirement to a statute is to ensure that laws do not punish innocent conduct, such as where a person commits a criminal act without criminal intent.108 moreover, if the goal is to protect ‘innocence’ by ruling out morally undeserved punishment, mens rea doctrine must do more than guarantee a modicum of moral blameworthiness as a precondition to punishment. it must also ensure that the acts which lead to criminal liability will be sufficiently blameworthy to deserve the sanctions imposed by the substantive offense. only then will ‘innocence’ truly be protected against criminal liability, and the traditional role of mens rea fulfilled.109 mens rea, therefore, can be the fulcrum upon which guilt and innocence rest. logically, mens rea requires efforts to examine and understand the defendant’s mind at the moment they committed the crime. to understand an individual’s mindset, consideration must be given to an individual’s intellectual disability when determining a defendant’s relative culpability. the maryland statute denied raymond that consideration, but indiana must not make the same mistake and leave a gap in its sexual misconduct with a minor statute. if the goal is to equitably and fairly administer justice, mens rea is the means for bringing about a more comprehensive and circumspect approach to assessing crimes committed by someone who has an intellectual disability. b. how indiana’s statute neglects the intellectually disabled population indiana’s statute governing sexual misconduct with a minor is not strict liability as it was in the garnett case; however, the problem exists where the statute remains silent. the statute states in relevant part: “[a] person at least eighteen (18) years of age who knowingly or intentionally performs or submits to sexual intercourse or other sexual conduct...with a child less than sixteen (16) years of age, commits sexual misconduct with a minor, a level 5 felony.”110 the offense is heightened to a level 4 felony if committed by a person who is age twenty-one (21) or older.111 the offense is further heightened to a level 1 felony if committed: by using or threatening the use of deadly force, if it is committed while armed with a deadly weapon, if it results in serious bodily injury, or if the commission of the offense is facilitated by furnishing the victim, without 107. legal positivism is defined as “the theory that legal rules are valid only because they are enacted by an existing political authority...not because they are grounded in morality or in natural law.” legal positivism, black’s law dictionary (11th ed. 2019). 108. stephen f. smith, proportional mens rea, 46 am. crim. l. rev. 127, 129 (2009). 109. id. at 127-28. 110. ind. code § 35-42-4-9(a) (2021). 111. ind. code § 35-42-4-9(a)(1) (2021). 104 indiana health law review [vol. 20:91 the victim’s knowledge, with a drug . . . or a controlled substance...or knowing that the victim was furnished with a drug or controlled substance without the victim’s knowledge.112 unlike the statute in the garnett case, indiana’s statute provides a defense based on mens rea if the defendant “reasonably believed” that the alleged victim was “at least sixteen (16) years of age at the time of the conduct.”113 however, this defense is inapplicable if the crime was committed under the circumstances described in section (a)(2).114 indiana’s statute also provides two more defenses that are founded on specific status relationships the defendant may possess. the first provides a defense if the two individuals involved are married, and the second provides a defense if the age gap does not exceed four years and the individuals are in an ongoing relationship; however, both defenses are likewise nullified by the circumstances described in section (a)(2).115 indiana’s mens rea requirement does not adequately guard against disproportionately punishing an individual with an intellectual disability. in 2019, indiana amended the statute to include “knowingly or intentionally” as the required mental element.116 in indiana, “[a] person engages in conduct ‘intentionally’ if, when he engages in the conduct, it is his conscious objective to do so.”117 likewise, “[a] person engages in conduct ‘knowingly’ if, when he engages in the conduct, he is aware of a high probability that he is doing so.”118 while this amendment may seem like a step that could help insulate people like raymond from disproportionate punishment, the added mens rea is a somewhat hollow consolation to someone in raymond’s position. the issue was not that raymond did not intend to have sex, but that he could not understand or be expected to understand that he may be criminally liable because erica’s age was not what she claimed it was. as discussed earlier, raymond conceded that he and erica engaged in voluntary sexual intercourse; his defense rested on the contention that his disability caused him to be deceived regarding erica’s age. additionally, once intent to perform an action is proven or conceded, the “knowingly” element is satisfied as well.119 indeed, attempting to envision a scenario where an individual did not know they were having sex or did not intend to have sex with a minor is likely quite rare.120 112. ind. code § 35-42-4-9(a)(2) (2021). 113. ind. code § 35-42-4-9(c) (2021). 114. id. 115. ind. code §§ 35-42-4-9(d), (e) (2021). 116. 2019 ind. als 40, 2019 ind. acts 40, 2019 ind. pl 40, 2019 ind. sea 551. 117. ind. code § 35-41-2-2(a) (2021). 118. ind. code § 35-41-2-2(b) (2021). 119. trevino v. state, 428 n.e.2d 263, 267 (ind. ct. app. 1981) (holding that “intentionally” is the highest degree of culpability, and that “if conduct is engaged in ‘intentionally,’ it necessarily follows that it must be engaged in ‘knowingly’ also.”). 120. for intent, extraordinary circumstances may exist where someone is forced to have sex 2023] defending disabilities 105 the pertinent aspect in indiana’s statute is the carve-out for a defense if the defendant “reasonably believed” that the victim was at least sixteen at the time the sexual activity occurred.121 the statute’s reasonable belief defense, however, still does not fully shield a defendant from liability. “knowledge of the victim’s age is not an element of the crime;” therefore, a defendant asserting this defense “admits all the elements of the crime but proves circumstances which excuse the defendant from culpability.”122 although the wording may seem to indicate that an intellectual disability could serve as an exculpatory or mitigating factor because of a mistake of age, indiana courts and additional statutes appear to indicate otherwise. an intellectual disability is generally not a defense to a crime.123 indiana has statutorily defined an individual with an intellectual disability as someone who manifests, before the age of twenty-two, “significantly subaverage [sic] intellectual functioning” and “substantial impairment of adaptive behavior.”124 these requisite symptoms must also be “documented in a court ordered evaluative report.”125 although this definition is consistent with the definition set forth in the dsm-5, in comparison, the statute’s definition is extremely superficial and lacks description.126 having such vague elements required for a finding that someone has an intellectual disability does not give the court or juries much guidance on how to understand an individual’s disability and, by extension, assess their culpability. what is more, the developmental disability statute is relevant only insomuch as it operates in conjunction with the death penalty statute.127 the relationship between intellectual disabilities and the death penalty stems from the united states supreme court’s landmark decision in atkins v. virginia.128 the issue in the atkins case was whether the death penalty should ever be imposed on individuals with intellectual disabilities after daryl atkins suffered capital punishment.129 daryl atkins was convicted of multiple crimes including abduction, capital murder, and armed robbery.130 atkins’ defense relied with a minor because of duress, but such scenarios are rare and not relevant to this note. for the knowledge element, a possible defense to this element could be extreme drunkenness, or being under the influence of drugs; however, these scenarios are also not within the purview of this note. 121. ind. code § 35-42-4-9(c) (2021). 122. moon v. state, 823 n.e.2d 710, 715 (ind. ct. app. 2005). 123. 21 am. jur. 2d, criminal law § 35 (2022). 124. ind. code § 35-36-9-2 (2021). 125. id. 126. compare id. (discussing the limitations an intellectual disability imposes in the broadest sense), with diagnostic and stat. manual of mental disorders, supra note 29 (providing concrete examples and diagnostic measures to properly identify an intellectual disability). 127. see ind. code § 35-36-9-2 (notes to decisions) (formerly named the mental retardation statute); see also rogers v. state, 698 n.e.2d. 1172, 1181 (ind. 1998). 128. see atkins v. virginia, 536 u.s. 304, 306-307 (2002). 129. id. at 307 (using the old label, “mental retardation,” instead of intellectual disability). 130. id. 106 indiana health law review [vol. 20:91 on dr. evan’s testimony, a forensic psychologist who testified that atkins had an intellectual disability and concluded, after administering an iq test, that atkins had an iq of 59.131 by way of comparison, raymond had an iq level of 52.132 despite the expert testimony and the arguments raised to mitigate sentencing, the jury sentenced atkins to death.133 upon appeal and review, the supreme court held that the death penalty would violate the eight amendment’s constitutional protection against “cruel and unusual punishment.”134 the court’s reasoning presented insightful considerations into how courts could apply punishment to individuals with intellectual disabilities, certain challenges faced by such individuals, and how justice is best served when these individuals do commit crimes. the opinion in atkins, penned by justice stevens, specifically highlighted language used by two dissenting justices from the virginia supreme court, justice hassell and justice koontz.135 both justices believed applying the death penalty to atkins was “excessive,” especially because atkins had the mental age of a child between the ages of nine and twelve.136 interestingly, justices hassell and koontz seem to echo the concerns voiced by the court in raymond’s case discussed earlier.137 the court continued to adopt koontz and hassell’s position, arguing that individuals with intellectual disabilities are necessarily, to some degree, less culpable for their actions.138 “by definition, such individuals have substantial limitations not shared by the general population. a moral and civilized society diminishes itself if its system of justice does not afford recognition and consideration of those limitations in a meaningful way.”139 the court voiced further that, regarding an intellectual disability’s impact on culpability, “[t]here is abundant evidence that [individuals with intellectual disabilities] often act on impulse rather than pursuant to a premediated plan, and that in group settings they are followers rather than leaders.”140 the court is right on the mark, as the dsm5 reinforces this very concern, “gullibility and lack of awareness of risk may result in exploitation by others and possible victimization, fraud, unintentional criminal involvement, false confessions, and risk for physical and sexual abuse. these associated features can be important in criminal cases. . . .”141 the united states supreme court has thus recognized some key aspects to intellectual disabilities that warrant more comprehensive evaluation. one could argue that the court is opening the door to unduly exonerating 131. id. at 308-09. 132. garnett, 632 a.2d at 798-99. 133. atkins, 536 u.s. at 309. 134. id. at 321. 135. id. at 310. 136. id. 137. compare id., with garnett, 632 a.2d. at 800. 138. atkins, 536 u.s. at 310. 139. id. 140. id. at 318. 141. diagnostic and stat. manual of mental disorders, supra note 29, at 38. 2023] defending disabilities 107 criminals from their bad actions and instituting an unfair deviation from the traditional standard of justice. the court, wisely, tried to preempt any criticism by qualifying its rationale in saying that the deficiencies inherent in an intellectual disability “do not warrant an exemption from criminal sanctions, but they do diminish their personal culpability.”142 one can infer from the court’s reasoning that lawmakers, judges, and juries should take notice that an intellectual disability is an essential aspect to consider when crafting laws and assessing proper degrees of punishment. to help develop this thesis, the court reviewed the general arguments for retribution and deterrence.143 regarding retribution, a punishment’s severity ought to be directly proportional to the offender’s culpability.144 proportionality is a timeless principle of the american criminal justice system and premised on the age-old axiom, “let the punishment fit the crime.” to assess culpability, though, an individual’s intellectual disability should be a natural and substantive factor in determining the severity of punishment. furthermore, an intellectual disability can interfere with deterrence-focused goals because individuals struggle to adequately comprehend “the possibility of execution as a penalty and, as a result, control their conduct based upon that information.”145 the court’s reasoning in atkins thoroughly analyzes the role intellectual disabilities play in assessing culpability and determining punishment. indeed, atkins indicates a significant shift in attitude towards intellectual disabilities in the law. the holding in atkins signals a departure from a more rigid application of the law to a more holistic evaluation of personal culpability. the atkins decision may have been a monumental victory for the rights and protection of individuals with intellectual disabilities, but the united states supreme court has recoiled at taking the next step. how to assess the culpability of individuals with intellectual disabilities in non-capital cases has essentially been ignored.146 indeed, the court has failed to recognize that intellectual disabilities be considered in any way in non-capital cases, either as a bar to punishment or even as a mitigating factor.147 the decision whether to include intellectual disabilities into the discussion at all regarding guilt or proportional punishment is left to each jurisdiction.148 as a result, individuals suffering from intellectual disabilities “can be sentenced to life without parole or other harsh mandatory sentences without an opportunity to present their mental condition as a mitigating factor that reduces their sentence.”149 indiana law has not changed much in response to the atkins decision. in one 142. atkins, 536 u.s. at 318. 143. id. at 319-20. 144. id. at 319. 145. id. at 320. 146. rachel e. barkow, the court of life and death: the two tracks of constitutional sentencing law and the case for uniformity, 107 mich. l. rev. 1145, 1161 (2009). 147. id. 148. id. 149. id. at 1161-62. 108 indiana health law review [vol. 20:91 sense, though, indiana was ahead of the game in terms of sentencing. in a 1998 case, four years before the united states supreme court decided atkins, the indiana supreme court held that sentencing a “mentally retarded” defendant to death or life without parole is prohibited.150 however, the indiana supreme court also held that, even where a defendant suffers from an inherited intellectual disability and has an iq of 67, “low mental capacity is not a defense to a criminal charge.”151 additionally, “the finding of mitigating factors is not mandatory but rests within the sound discretion of the court.”152 therefore, in indiana, the fate of an individual like raymond who has an intellectual disability rests solely within the court’s discretion. even where a court may find that an intellectual disability exists, “a finding concerning a defendant’s mental retardation determines only his or her eligibility for a particular criminal punishment.” therefore, an intellectual disability cannot serve as a bar to conviction, and its purpose of mitigating sentencing is reduced to capital cases. c. lloyd v. state indiana’s statute remains silent on issues of intellectual disabilities153; indeed, there is a dearth of indiana cases addressing the issue of sexual misconduct that also include a discussion of intellectual disabilities. many indiana cases involve individuals with intellectual disabilities being the victims of sexual misconduct154; however, only one indiana case addresses the issue where the defendant is the one with an intellectual disability.155 although this single case is unpublished, precedential force is not the main concern. the case still helpfully illustrates how indiana has applied the statute governing sexual misconduct with a minor. lloyd v. state is a case from 2008 where chester lloyd, a forty-four-year-old man, was arrested and charged with sexual misconduct with a minor.156 two psychiatrists examined lloyd several months later (but before trial) and found that he was “mentally disturbed, interrupted by hallucinations, and seemed to respond to unseen stimuli.”157 additionally, the psychiatrists reported that he “failed to understand the scope of the charges against him, the role of many courtroom personnel, or the nature of courtroom proceedings.”158 these behaviors generally track with the described limitations of an intellectual disability; that is, being unable to understand proper social functions and appreciate societal 150. rogers, 698 n.e.2d at 1173. 151. hester v. state, 512 n.e.2d 1110, 1112 (ind. 1987). 152. magers v. state, 621 n.e.2d 323, 324 (ind. 1993). 153. see ind. code § 35-42-4-9 (2021). 154. see generally, e.g., mefford v. state, 983 n.e.2d 232 (ind. ct. app. 2013); hamilton v. state, 955 n.e.2d 723 (ind. 2011); krumm v. state, 793 n.e.2d 1170 (ind. ct. app. 2003). 155. lloyd v. state, no. 79a02-0704-cr-356, 2008 ind. app. unpub. lexis 420, at *1 (2008). 156. id. at *2. 157. id. at *3. 158. id. 2023] defending disabilities 109 expectations regarding the law.159 lloyd received treatment for his symptoms and stood trial several months later.160 the trial court sentenced him to thirty-years at the department of correction, citing his lengthy criminal history as a justifying factor.161 lloyd filed an appeal claiming that the trial court abused its discretion in sentencing because it did not consider his mental illness as a mitigating factor.162 the appellate court agreed that lloyd’s mental state should have been considered by the trial court as a mitigating factor.163 the court took note that, during the interim period following the charges, and before he stood trial, a forensic psychologist reported lloyd to be mentally retarded.164 indeed, the court stated in its own words, “with regard to the character of the offender, we note that lloyd is mentally retarded...has low intellectual functioning, is illiterate, and hallucinates at times.”165 despite the testimony of doctors and psychologists, results of testing while hospitalized, and the challenges that the court admitted lloyd faced, the indiana court of appeals affirmed lloyd’s maximum, enhanced sentence and the consecutive, presumptive sentence of ten years, amounting to a thirty-year confinement.166 furthermore, the appellate court offered only a minimal explanation for how it reached its decision. the main rationale, according to the court, was that lloyd’s criminal history and “failure to be rehabilitated” outweighed the impact his disability had on mitigating his culpability.167 the appellate court’s decision in lloyd is concerning for multiple reasons, but primarily because the rationale provided does not adequately address the issue of intellectual disability. although the court acknowledges that lloyd’s mental state should be weighed as a mitigating factor, its analysis focuses heavily on the aggravating circumstances.168 indeed, beyond listing lloyd’s diagnoses and symptoms, the court gives no indication that it considered how his mental state may have affected his culpability. though the court did state that lloyd’s inability to rehabilitate was concerning, this fact should not have carried significant weight considering that learning from one’s mistakes and understanding the consequences of one’s actions are common limitations imposed by intellectual disabilities.169 lloyd highlights the knowledge, understanding, and experience lacking in indiana’s courts when evaluating intellectual disabilities. arguably, should 159. see diagnostic and stat. manual of mental disorders, supra note 29, at 31. 160. lloyd, 2008 ind. app. unpub. lexis 420, at *3. 161. id. at *3-5. 162. id. at *6. 163. id. at *11-12. 164. id. at *11. 165. id. at *14. 166. id. 167. id. at *12-13. 168. see generally id. at *12-15. 169. diagnostic and stat. manual of mental disorders, supra note 29, at 31. 110 indiana health law review [vol. 20:91 indiana courts face another fact-pattern similar to garnett or lloyd, it would essentially be an issue of first impression. since no cases exist in indiana that squarely align with the issues presented in garnett, indiana’s courts lack guidance on how to apply the current reasonable belief defense in indiana’s sexual misconduct with a minor statute to individuals with intellectual disabilities. this looming issue presents indiana legislators with the opportunity to amend a statute in anticipation of a problem. what lawmakers need to recognize is the severely adverse effects individuals with intellectual disabilities suffer when involved in the criminal justice system—even when appropriately found guilty. the fact that individuals with intellectual disabilities suffer abuse from the criminal justice system and traditional punishment demands that statutory language account for intellectual disabilities. the issue cannot be stressed enough. data from the centers for disease control and prevention has indicated that rates of children being born with intellectual disabilities has been steadily increasing.170 intellectual disabilities are going to play a larger role in the criminal justice system, so preparation is crucial. as more information regarding mental health is discovered, and as people become more forthcoming about the actual challenges they face from their intellectual disabilities, all parties involved in the criminal process ought to be well-apprised of how to more equitably apply the principles of justice. although it has not encountered issues yet outside of lloyd, indiana stands at a pivotal point in time where evolving and existing problems could be preemptively legislated for to avoid concerns about the inequitable application of justice. after all, at the most basic level, laws are meant to protect the innocent and punish the guilty. d. theories of punishment applied to intellectual disabilities lawmakers have the responsibility to write and enact laws that, by nature, carry with them various levels of punishment for people who violate these laws. instinctively, most people believe that punishment should be proportional. to be sure, one can hope that indiana legislators seek to achieve proportionality and justice in the laws they draft and the punishments those laws impose. however, no system is perfect, and an equitable application of justice is at the mercy of human fallibility. virtually no one disagrees that bad actions should be punished, that victims should be cured of their injuries, and that the common good should be protected. as these principles become applied to concrete situations, however, views quickly deviate. how to apply the principles of our criminal justice system is the perennial question affecting indiana’s legislators. punishment is a critical aspect of lawmaking, though presumably the most unsavory. punishment “intentionally inflicts pain on persons convicted of criminal conduct by taking their life, liberty, 170. benjamin zablotsky et al., estimated prevalence of children with diagnosed developmental disabilities in the united states 2014-2016, nat’l ctr. health stat. data brief 1, 2 (2017). 2023] defending disabilities 111 and/or property.”171 indeed, the quality and future of so many lives hinge upon this weighty affair. statutory language is the primary medium for codifying criminal behavior and the attendant consequences. “lawmakers must ascertain not only what conduct is wrongful but must also determine who may properly be held accountable for the wrongful conduct.”172 even more, “when punishment is deemed appropriate, legislators must decide what and how much punishment fits the offense and the offender.”173 with such great power, lawmakers possess a duty to protect indiana’s interests and the citizens whose lives their laws may impact. however, any system that intentionally inflicts suffering requires justification.174 two theories of punishment have emerged that essentially encapsulate the prevailing rationales for imposing punishment: retributivism and utilitarianism.175 each theory espouses a different focus when viewing how to assess punishment while also providing a different justification for their respective methods. retributivism is more focused on past wrongdoing; a person who commits a crime deserves punishment merely because he or she committed that crime.176 understandably, retributivism is more backward-looking. the retributivist position mirrors a strict liability mentality because it focuses primarily on the actus reus rather than taking a defendant’s mental state into consideration.177 in a sense, a retributivist seems to adopt the position of a legal positivist—if someone performs an action, and that action is forbidden by law, the inquiry is essentially complete.178 punishment becomes due. retributivists do face the question of “how much” when considering punishment, and the general consensus is that the punishment must be proportional to the crime.179 here, at least, retributivists make some qualification regarding a punishment’s severity. arguably, this presents an opportunity to delve into the mens rea analysis. however, “a distinctive aspect of retributivism is that the moral desert of an offender is a sufficient reason to punish him or her...such 171. dressler, supra note 101, at 11. 172. id. 173. id. 174. id. 175. dressler & garvey, supra note 99, at 34. 176. id. at 35. 177. see strict-liability crime, black’s law dictionary (11th ed. 2019) (defining strict liability as “an offense for which the action alone is enough to warrant a conviction, with no need to prove a mental state.”). 178. legal positivism is defined as, “the theory that legal rules are valid only because they are enacted by an existing political authority...not because they are grounded in morality or in natural law.” legal positivism, black’s law dictionary (11th ed. 2019). 179. dressler & garvey, supra note 99, at 41 (citing michael s. moore, responsibility, character, and the emotions: new essays in moral psychology 179-82 (ferdinand schoeman ed., 1987)). 112 indiana health law review [vol. 20:91 moral desert [is] only a necessary condition of punishment.”180 the theory does not seem to comprehend a situation where the actor, though he or she committed the illegal action, can be exonerated by mitigating circumstances—because the action occurred, someone must be punished. retributivist justifications, then, seem to pose dangers for individuals with intellectual disabilities who would attempt to demonstrate that they lack culpability by citing their mental limitations. raymond’s case is a perfect example. raymond was unable to use the factual findings in his case and the real limitations he faced from his disability to explain his actions or even mitigate his sentence. under a retributivist view, raymond performed the action, so he must be punished. the retributivist, however, neglects to consider a crucial distinction regarding punishment. although the punishment imposed by a conviction of statutory rape may be proportional to the crime, it may not be proportional to the person. herein lies the tragedy of raymond’s case: a young man with down syndrome, deceived by a friend, was labeled a rapist and a felon and made to carry an even heavier burden than the one he was born with. in contrast, utilitarianism is more forward-looking by being less concerned with the criminal actor and more focused on “the supposed benefits that will accrue” from imposing punishment.181 at first glance, this appears similar to the retributivist approach because, at least on its face, it fails to address any mens rea consideration. utilitarianism does consider the individual, at least in some sense, as an individual’s good is tied to the overall benefits that accrue from punishment. one benefit includes general deterrence, since the knowledge and threat of impending punishment would seem to deter a reasonable person from committing that crime, thus “reducing future violations” and the suffering they cause.182 deterrence is somewhat twofold, as punishing an individual for a crime can serve to deter both the one punished and those who perceive that such actions will lead them to the same punishment. therefore, punishing an individual, whose culpability is arguably mitigated (or even absent) because of his disability, may very well help deter others. for instance, a criminal with average intellectual and adaptive ability may conclude that, if someone with an intellectual disability can be convicted of such-and-such crime, then there is certainly a lesser chance for someone like himself to escape liability. however, does this deterrence argument have a similar effect on individuals who are intellectually disabled? most likely not, as “learning from experience” is one of the primary limitations associated with intellectual disability.183 punishment as a means of deterrence is only helpful insofar as the individual can make the connection between performing a bad action and receiving punishment because of that bad action. utilitarianism thus begs the question: should an individual with an intellectual disability be disproportionately punished merely to stop “normal” people—arguably more 180. id. at 42. 181. id. at 36. 182. kent greenwalt, punishment, 3 encyclopedia of crime and justice 1282, 1286-87 (joshua dressler ed., 2d ed. 2002). 183. diagnostic and stat. manual of mental disorders, supra note 29, at 33. 2023] defending disabilities 113 culpable and aware their actions are blameworthy—from committing the same crime? this apparent imbalance seems to undercut the utilitarian theory that punishment facilitates individual deterrence as well. according to the utilitarian, punishment facilitates individual deterrence because, in theory, “the actual imposition of punishment creates fear in the offender... a penalty should be severe enough to outweigh in his [the offender’s] mind the benefits of the crime.”184 this premise reveals a problem when applied to individuals with intellectual disabilities, because one’s disability often frustrates the goal; that is, to promote greater discernment when an individual is thinking about committing a crime. so, again, this benefit appears to gloss over possible exceptions to its theory such as individuals with intellectual disabilities. the last social benefit conceived by utilitarianism is reform. “reform is usually conceived as involving more positive steps to make offenders less antisocial by altering their basic character, improving their skills, or teaching them how to control their crime-producing urges.”185 conceptually, this plan seems practical and effective; however, an intellectual disability can severely hinder an individual from understanding the broader, future implications of punishment. reform is probably the most realistic goal for individuals with intellectual disabilities, and probably a prerequisite step for achieving deterrence on the individual level. taking these theories of punishment into consideration, indiana legislators must recognize that its sexual misconduct with a minor statute fails to provide for proportional evaluation and punishment of individuals with intellectual disabilities. simply put, people like raymond demand more individualized consideration than the broad, justifying principles espoused by retributivism or utilitarianism. punishment, at the most fundamental level, must be fair in a society that values justice. punishment is also necessary based upon human nature; consequences from actions generate a causal link between certain behavior and certain effects, thus creating a negative association within the individual and society regarding that behavior. punishment—when applied properly—can be conducive to fostering a safe and secure society that promotes well-being. equitable application is difficult but including intellectual disabilities into the analysis is essential to maintaining the integrity of the criminal justice system and of fairly administering justice. for the crime of sexual misconduct with a minor, a crime that carries lasting stigmas, statutory language must account for intellectual disabilities as a mitigating, or even exculpatory, factor in assessing an individual’s culpability and provide individuals with alternatives punishment. e. diversion: a path to equitable punishment and true rehabilitation to protect its citizens from unjust punishment and potential abuse in the criminal justice system, indiana should amend its sexual misconduct with a minor 184. greenwalt, supra note 182. 185. id. 114 indiana health law review [vol. 20:91 statute to include a diversion program codified in the california penal code.186 despite the political climate in indiana being staunchly conservative, and this proposed program hailing from a liberal state, the following solution ought to be a viable option for indiana. indeed, helping to more equitably administer justice, especially to indiana residents who may not have the resources to advocate for themselves, should not be a politically charged issue. the proper administration of justice should know no political party. in 1997, the ninth circuit decided a class action case brought by individuals with developmental disabilities who were incarcerated in various correctional facilities operated by the state of california.187 the class alleged discriminatory treatment by the named correctional facilities based on the disabilities shared by its members.188 by its decision, “the court recognized [individuals with intellectual disabilities] are vulnerable to physical, sexual and verbal abuse, exploitation . . . and that they require accommodations from the usual routines of incarcerated life.”189 the california legislature responded to this case and calls for criminal justice reform by instituting the diversion program included in the clark remedial plan, a plan put together by the california department of corrections and rehabilitation to facilitate a better environment for incarcerated individuals who possess various disabilities.190 the clark remedial plan—essentially a policy guideline assembled by the department of corrections and rehabilitation to comply with the terms of the settlement in clark—codified certain measures to address prison reform, thus providing correctional facilities with specific guidelines to streamline processes designed to help these individuals.191 first, facilities should proactively seek to identify individuals with disabilities so that they can provide adequate accommodations.192 second, correctional facilities should provide proper education to incarcerated individuals on how to avoid recidivism and how better to mold their behavior to comply with the law.193 in a similar vein, correctional 186. see generally cal. penal code § 1001.22 (deering 2022). 187. clark v. california dep’t of corr., 123 f.3d 1267, 1269 (9th cir. 1997). (although this case was brought by individuals with developmental disabilities, a developmental disability is simply a “broader category” that includes all intellectual disabilities, but also encompasses physical disabilities.). see nat’l. inst. of health, about intellectual and developmental disabilities (idds), https://www.nichd.nih.gov/health/topics/idds/conditioninfo [https://perma.cc/gtq6mapb] (last updated nov. 9, 2021). 188. clark, 123 f.3d at 1269. 189. jim concannon, our weakest members: developmentally disabled people in the criminal justice system, lexipol (feb. 13, 2019), https://www.lexipol.com/resources/blog/ developmentally-disabled-people-in-the-criminal-justice-system/ [https://perma.cc/3ylx-cl4g]. 190. id.; see generally clark, 123 f.3d at 1267. 191. see generally clark remedial plan, cal. dep’t of corr., https://prisonlaw.com/wpcontent/uploads/2020/01/clark-v-california-clark-remedial-plan.pdf [https://perma.cc/a3pxt9ef]. 192. concannon, supra note 189. 193. id. 2023] defending disabilities 115 facilities have a duty to protect inmates with disabilities from violence, abuse, and exploitation, as well as assist the inmates with their own self-care and hygiene.194 the clark remedial plan acknowledges the need for not just better treatment, but the need for efficacious rehabilitation. indiana’s legislature should amend its sexual misconduct with a minor statute by adding language similar to § 1001.22 of the california penal code to indiana’s reasonable belief defense.195 the penal code uses the phrase “diversion-related treatment and habitation” and defines such treatment as including “specialized services . . . directed toward the alleviation of developmental disability or toward social, physical, or economic habilitation or rehabilitation of an individual with a developmental disability.”196 some of these specialized services include diagnosis, professional evaluation, treatment, therapy, counseling, employment opportunities, and even domiciliary care and personal living arrangements.197 rather than let jury members or judges—who likely have only a minimal understanding of intellectual disabilities—determine culpability and what punishment is appropriate, the diversion program places the treatment of these individuals in the hands of experienced health professionals. the application of this chapter of the penal code applies to any offense charged as a misdemeanor or a felony, with some exceptions (e.g., murder).198 diversion becomes an option when the court suspects that a defendant has a disability and the defendant subsequently consents to the program.199 the code further provides the court with the power to refer the defendant, if consenting and found eligible, to a regional center where he or she would be evaluated to determine whether they qualify for certain treatments and/or habitation.200 the court then seeks input on this issue from the district attorney, the probation department and regional center, as well as the public defender, after which the court has the power to order diversion.201 by adopting this program, indiana would fill the gap in its sexual misconduct with a minor statute and guard against further abuse from the criminal justice system. this diversion approach is a net benefit for all parties involved. while crimes are still punished and the integrity of indiana law is protected, the interests of individuals with intellectual disabilities are likewise protected, and they are held accountable for their actions in a way that protects their rights and rehabilitates them more effectively. unlike raymond’s case, this program acknowledges and appreciates the challenges individuals face from their disabilities. therefore, indiana should amend the statute on sexual misconduct with a minor to provide a diversion option should an individual qualify for 194. id. 195. compare ind. code § 35-42-4-9(c), with cal. penal code § 1001.22 (deering 2022). 196. cal. penal code § 1001.20 (2022). 197. id. 198. cal. penal code § 1001.21 (deering 2022). 199. cal. penal code § 1001.22 (deering 2022). 200. concannon, supra note 189. 201. id. 116 indiana health law review [vol. 20:91 alternative treatment under the law pending an evaluation. then, if diversion is appropriate, the individual would be placed in a facility most appropriate based off the recommendations of experienced mental health professionals, and justice would be truly proportional. iv. conclusion indiana should amend its statute governing sexual misconduct with a minor and institute new adjudicatory and punitive procedures to justly charge and punish individuals who possess intellectual disabilities. since the supreme court’s decision in atkins v. virginia, awareness of and concern for individuals with intellectual disabilities in the criminal justice system are rising. as evidenced by the garnett v. state case, individuals who suffer moderate intellectual disabilities are not receiving just treatment under the law. even more, the plight of individuals with intellectual disabilities continues throughout each step of the criminal process, especially once they are incarcerated. because individuals with intellectual disabilities struggle with adaptive and cognitive functioning, they struggle to understand consequences and have difficulty controlling their natural impulses. raymond garnett is a prime example of someone who failed to understand the law, and his is not an isolated case. the somber reality is that indiana’s statute is written in such a way that it fails to account for intellectual disabilities and thus risks unjust prosecution and incarceration. indiana’s statute governing sexual misconduct with a minor lack the necessary language to properly assess culpability for a violator who has an intellectual disability. because intellectual disabilities pose new challenges and raise questions about an individual’s culpability, additional language is needed in the statute to provide a better alternative for criminal evaluation and punishment. an intellectual disability does not necessarily make someone immune from liability by any means, but it certainly can play a mitigating role, especially when strong natural impulses like sex are part of the crime. the key issue is whether an individual with an intellectual disability truly appreciates the wrongfulness of his or her actions enough to warrant incarceration and even whether incarceration is the best option for punishment. indiana is poised to address the newer issue of intellectual disability and its place in the domain of punishment. indiana should adopt the diversion program codified in the california penal code. this program allows for individuals to be diverted from traditional courtroom procedures so medical professionals can evaluate their disability. furthermore, the program provides alternative rehabilitation locations so that these individuals can receive therapy, education, and even a place to live while serving their sentence. although indiana is a more conservative state and this program began in california, the health and well-being of some of indiana’s weakest members is not something to be politicized. indiana stands in a position to positively and preemptively address the issues involved with intellectual disabilities and criminal punishment. lead: the latest federal actions and best practices lead: the latest federal actions and best practices carlton waterhouse * i. background – the lead story lead has an old and even ancient legacy of harm to humans. 1 despite this history, lead was widely used in the development of consumer goods used for and around children in the united states during the industrial era. 2 the decision to use it in two widely distributed commercial products created a public health nightmare. leaded gasoline and leaded paint robbed countless children and adults of opportunities for greater economic prosperity, educational achievement, and deeper social engagement. 3 moreover, death and disease have been visited upon millions of unsuspecting families and individuals around the world because of their exposure to lead. 4 in the united states alone, deaths attributable to lead exposure have been estimated at over four hundred thousand.5 at the global level, the world health organization has made the following determinations: lead exposure can have serious consequences for the health of children. at high levels of exposure to lead the brain and central nervous system can be severely damaged, which could result in a coma, convulsions, and even death. children who survive severe lead poisoning may be left with permanent intellectual disability and behavioral disorders. at lower levels of exposure that cause no obvious symptoms, lead is now known to produce a spectrum of injury across multiple body systems. in particular, lead can affect children’s brain development, resulting in reduced intelligence quotient (iq), behavioral changes such as reduced ————————————————————————————— * professor of law and environmental and climate justice center director at the howard university school of law. the author thanks the editors of the indiana health law review for their valuable assistance in publishing the article and the howard university school of law environmental justice fellows and student researchers for their time and dedication to the fifty state lead survey cited herein. 1. milton a. lessler, lead and lead poisoning from antiquity to modern times, 88 ohio j. sci. 78, 79 (1988). (“among the earliest records, whether on papyrus, copper, parchment or cuneiform writing on clay, there are notes that lead miners and individuals who worked with lead developed ailments that resulted in their early demise. this was first well documented by the egyptians who used slaves in their mines and later by the pregreeks, greeks, and romans.”) 2. richard rabin, warnings unheeded: a history of child lead poisoning, 79 am. j. pub. health 1668, 1672-73 (1989). 3. timothy dignam et al., control of lead sources in the united states, 1970-2017: public health progress and current challenges to eliminating lead exposure, 25 j. pub. health mgmt. & prac. 1, 3-4 (2019) (author manuscript) (on file at https://www.ncbi.nlm.nih. gov/pmc/articles/pmc6522252/ [https://perma.cc/p7yt-jt9r]). 4. dylan matthews, lead poisoning could be killing more people than hiv, malaria, and car accidents combined, vox (sept. 14, 2023), https://www.vox.com/future-perfect/ 2023/9/14/23868347/lead-poisoning-death-toll-world-bank-pure-earth#:~:text=these%20are%2 0massive%20numbers%2c%20and,and%20malaria%20(643%2c381)%20combined [https:// perma.cc/59ch-sgp8]. 5. bruce p. lanphear et al., low-level lead exposure and mortality in us adults: a population-based cohort study, 3 lancet pub. health 177, 182 (2018). https://www.vox.com/future-perfect https://perma.cc/p7yt-jt9r https://www.ncbi.nlm.nih indiana health law review [vol. 21:355 356 attention span and increased antisocial behavior, and reduced educational attainment. lead exposure also causes anemia, hypertension, renal impairment, immunotoxicity, and toxicity to the reproductive organs. the neurological and behavioral effects of lead are believed to be irreversible. there is no known safe blood lead concentration; even blood lead concentrations as low as 3.5 µg/dl may be associated with decreased intelligence in children, behavioral difficulties and learning problems. 6 the world health organization’s 2021 update of the public health impact of chemicals: knowns and unknowns estimated that nearly half of the two million lives lost to known chemicals exposure in 2019 were due to exposure to lead. 7 lead exposure is estimated to account for 21.7 million years lost to disability and death (disability-adjusted life years, or dalys) worldwide due to long-term effects on health, including 30% of the global burden of idiopathic intellectual disability, 4.6% of the global burden of cardiovascular disease and 3% of the global burden of chronic kidney diseases. 8 the harm that lead exposure causes to humans was suspected in the ancient world and has been well documented since the early to mid-twentieth century based on occupational and childhood exposures. 9 although naturally occurring, lead poses substantial heath risk when introduced into the human body. 10 the exposure pathways that lead to lead poisoning follow two primary routes— ingestion and inhalation. 11 adults working with lead in the lead mining, smelting, and other industries were historically exposed through dermal absorption as well. 12 children exposed to lead through the years have been exposed throughout their environments. 13 inside homes, in yards and playgrounds, in schools, daycare centers, and nurseries, children have been and continue to be exposed through inhalation and ingestion of lead dust and lead paint, as well as lead in water, food, and toys. 14 the flint water crisis provided the country with a clear example of the ————————————————————————————— 6. lead poisoning, world health organization (aug. 11, 2023), https://www.who.int/ news-room/fact-sheets/detail/lead-poisoning-and-health [https://perma.cc/2c5u-f26j].]. 7. the public health impact of chemicals: knowns and unknowns, world health org. (may 23, 2016), https://www.who.int/publications/i/item/who-fwc-phe-epe-16-01 [https:// perma.cc/p9qv-mukq]. 8. lead poisoning, world health org. (aug. 11, 2023), https://www.who.int/newsroom/fact-sheets/detail/lead-poisoning-and-health [https://perma.cc/62ws-zkkw]. 9. herbert l. needleman, history of lead poisoning in the world 1-4 (1999), https://www.biologicaldiversity.org/campaigns/get_the_lead_out/pdfs/health/needleman_1999. pdf [https://perma.cc/nef4-rse9]. 10. see generally u.s. dep’t of health & hum. ser., toxicological profile for lead vi (aug. 2020), https://www.atsdr.cdc.gov/toxprofiles/tp13.pdf [https://perma.cc/jp2b-7yy]. 11. id. at 12. 12. id. 13. rabin, supra note 2, at 1669 (as early as 1924 it was recognized that, “[a] child lives in a lead world”). 14. dignam et al., supra note 3, at 3-8. https://perma.cc/jp2b-7yy https://www.atsdr.cdc.gov/toxprofiles/tp13.pdf https://perma.cc/nef4-rse9 https://www.biologicaldiversity.org/campaigns/get_the_lead_out/pdfs/health/needleman_1999 https://perma.cc/62ws-zkkw https://www.who.int/news https://www.who.int/publications/i/item/who-fwc-phe-epe-16-01 https://perma.cc/2c5u-f26j https://www.who.int 2024] lead: the latest federal actions and 357 best practices continuing harm that lead inflicts upon america’s children and its race and class dimensions. 15 while lead poses an equal threat to all children poisoned by it, children are not equally exposed to lead. 16 in its 1992 report, reducing risk to all communities, the u.s. environmental protection agency (epa) recognized that lead was unique in the level of scientific data available regarding childhood lead exposure and the blood lead elevation that results from it. 17 there are clear and dramatic disparities among ethnic groups for death rates, life expectancy, and disease rates. there is also a surprising lack of data on human exposures to environmental pollutants for whites as well as for ethnic and racial minorities. one exception is lead exposures in children, and there the data are unequivocal: black children have disproportionately higher blood lead levels than white children even when socioeconomic variables are factored in.18 the disparities in elevated blood lead levels the agency found in 1992 persist today.19 lead remains one of the nation’s most stark and persistent examples of environmental injustice. race and socioeconomic status together and independently represent the best predictors of elevated blood lead levels in children.20 as the flint water crisis demonstrated, environmental justice alludes communities vulnerable to governmental indifference and neglect. through both foreseeable and unintended outcomes of corporate and government actions, countless children have suffered death and long-term harm from lead exposure. 21 scholars and advocates continue to sound the alarm by calling for greater governmental action to remove lead from the places where it threatens children. 22 as a matter of public health, environmental protection, and ————————————————————————————— 15. see hope kerpelman, let them eat paint: childhood lead paint poisoning as the denial of constitutional and civil rights, 51.2 colum. hum. rts. l. rev. 828, 828 (2020). 16. id. at 843-48. 17. u.s. env’t prot. agency, environmental equity reducing risk for all communities 1, 15 (june 1992), https://www.epa.gov/sites/default/files/2015-02/documents/ reducing_risk_com_vol1.pdf [https://perma.cc/s6wp-wtvx]. 18. id. 19. andrea e. cassidy-bushrow et al., burden of higher lead exposure in africanamericans starts in utero and persists into childhood, 108 env’t int’l 221, 221-27 (nov. 2017). 20. see kerpelman, supra note 15, at 843. 21. kerpelman, supra note 15, at 840-41; see also howard mielke & sara egendorf, getting the lead out: a career-long perspective on leaded gasoline, dust, soil, and proactive pediatric exposure prevention, 11 med. rsch. archives 1, 2-4 (may 26, 2023); see generally rabin, supra note 2, at 1668-1674. 22. see emily a. benfer, contaminated childhood: how the united states failed to prevent the chronic lead poisoning of low-income children and communities of color, 41 harv. env’t l. rev. 493, 493 (2017); emily a. benfer et al., health justice strategies to eradicate lead poisoning: an urgent call to action to safeguard future generations, 19 yale j. health pol’y l. & ethics 122, 146 (2020) [hereinafter health justice strategies]; emily a. benfer et al., duty to protect: enhancing the federal framework to prevent childhood lead poisoning and exposure to environmental harm, 18 yale j. health pol’y l. & ethics 1, 27-37 (2019) https://perma.cc/s6wp-wtvx https://www.epa.gov/sites/default/files/2015-02/documents indiana health law review [vol. 21:355 358 environmental justice, legal scholarship has astutely called for more protection for children from lead exposures. 23 while many articles speak to the problem of lead generally or to more specific concerns such as lead based paint exposures or varied aspects of the flint crisis, more attention to the specific law and policy interventions needed to reduce lead exposure for the nation’s children is needed. 24 those that do, focus on federal action—providing critical guidance to the executive branch on eliminating lead exposures from the lives of children. 25 yet, in the environmental arena protection of public and health and welfare depend on federal, state, and local government actors coordinated efforts. 26 this article responds to the existing literature calling for governmental action and legal reform by identifying some significant developments at both the federal and state level in lead protection and their importance. part ii of this article examines the centers for disease control (cdc) revised blood lead reference value issued in 2021 and epa’s 2022 final strategy to reduce lead exposures and disparities in u.s. communities. 27 in part iii, this article addresses the under examined role of state law in securing health protection for children and pregnant women. the state law analysis draws on the preliminary findings of a nationwide state lead protection program review conducted by the howard university school of law environmental and climate justice center and the 2017 children at risk: gaps in state lead screening policies report by jennifer dickman and safer chemicals healthy families. 28 best state practices for primary prevention are highlighted in this section. part iv offers conclusions and next steps. ————————————————————————————— [hereinafter duty to protect] (proposing explicit epa actions to remove lead from air, water, and soil). 23. see montrece mcneill ransom et al., toward eradication: how law and public health practices can be used to prevent childhood lead poisoning, 22 tul. env’t. l. j. 1, 4 (2008); see also benfer, supra note 22, at 493; health justice strategies, supra note 22, at 146; kerpelman, supra note 15, at 840-41. 24. duty to protect, supra note 22, at 27-37 (providing an exemplary in-depth analysis of interventions necessary to make meaningful progress on reducing lead exposure through primary prevention); see generally brie d. sherman, pride and prejudice and administrative zombies: how economic woes, outdated environmental regulations, and state exceptionalism failed flint, michigan, 88 u. colo. l. rev. 653 (2017) (exploring the origins of the flint water crisis); see also health justice strategies, supra note 22, at 146-60. 25. duty to protect, supra note 22, at 27-37; see also health justice strategies, supra note 22, at 146-160. 26. see generally robert v. percival, environmental federalism: historical roots and contemporary models, 54 md. l. rev. 1141 (1995). 27. see infra, part ii b. 28. jennifer dickman & safer chem. healthy fam., children at risk: gaps in state lead screening policies 1 (jan. 2017), https://toxicfreefuture.org/wp-content/uploads/2017/01/ saferchemicals.org_children-at-risk-report.pdf [https://perma.cc/4bje-3shf]. https://perma.cc/4bje-3shf https://toxicfreefuture.org/wp-content/uploads/2017/01 2024] lead: the latest federal actions and 359 best practices ii. cdc and epa advance a. cdc acts the cdc provides national leadership on lead protection standards, especially for children. 29 in its role as the nation’s “leading science-based, datadriven, service organization that protects the public’s health,” cdc’s efforts under its childhood lead poisoning prevention program date back over half a century. 30 its most recent approach to establish lead protection standards for children can be traced back to november 10, 2010 when the cdc advisory committee for childhood lead poisoning prevention (acclpp) established the blood lead level (bll) workgroup. 31 on january 4, 2012, the acclpp approved the work group’s report that called for new approaches and commitments by the cdc to protect children from lead exposure. 32 the report called for a number of actions by cdc to strengthen and support primary and secondary prevention efforts. 33 the first and most important of which follow below: i. recommendation: based on the scientific evidence, the acclpp recommends that the term, “level of concern”, be eliminated from all future agency policies, guidance documents, and other cdc publications, and that current recommendations based on the “level of concern” be updated according to the recommendations contained in this report. . . . ii. recommendation: cdc should use a childhood bll reference value based on the 97.5th percentile of the population bll in children ages 1-5 (currently 5 μg/dl) to identify children and environments associated with lead-exposure hazards. the reference value should be updated by cdc every four years based on the most recent population-based blood lead surveys among children. 34 the first recommendation called for cdc to abandon its prior approach of ————————————————————————————— 29. ettinger as, leonard ml, mason j. cdc’s lead poisoning prevention program: a long-standing responsibility and commitment to protect children from lead exposure. j public health manag pract. 2019 jan/feb;25 suppl 1, lead poisoning prevention available at https:// www.ncbi.nlm.nih.gov/pmc/articles/pmc6320665/; see also cdc childhood lead poisoning and prevention program description available at https://www.cdc.gov/nceh/lead/about/program. htm. 30. 1970s 1980s timeline, ctr. for disease control & prevention (last reviewed april 6, 2021), https://www.cdc.gov/nceh/lead/about/1980s.html#1970s [https://perma.cc/5xczln3g]. 31. ctr. for disease control & prevention, cdc response to advisory committee on childhood lead poisoning prevention 1 (june 7, 2012), https://www.cdc.gov/ nceh/lead/docs/cdc_response_lead_exposure_recs.pdf [https://perma.cc/2ub9-t7u6]. 32. id. at 2. 33. id. at 2-3. 34. id. at 5-6. https://perma.cc/2ub9-t7u6 https://www.cdc.gov https://perma.cc/5xcz https://www.cdc.gov/nceh/lead/about/1980s.html#1970s https://www.cdc.gov/nceh/lead/about/program https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6320665 indiana health law review [vol. 21:355 360 identifying children as having a blood lead “level of concern” when blood lead screening indicated 10 or more micrograms per deciliter (µg/dl) of lead in a child’s blood. 35 this approach was rejected by the group “based on the compelling evidence that low blls are associated with iq deficits, attentionrelated behaviors, and poor academic achievement.”36 moreover, the aclpp workgroup pointed to “the absence of an identified bll without deleterious effects, combined with the evidence that these effects appear to be irreversible. . . .”37 building on the shift away from the “level of concern approach,” the group called for the creation and use of a blood lead reference value tied to the blood lead levels of the 97.5 percentile of children nationwide. 38 under the old system, parents were not generally informed that their children had blood levels less than 10 µg/dl. 39 the new system would mean that parents and healthcare professionals could address elevated blood lead levels through intervention and education. the blood lead level values would be based on data from the blood lead surveys of children around the country collected and updated in association with the national health and nutrition examination survey (nhanes) every four years. 40 at the time, the 97.5 percentile of the blood lead level distribution among children between one and five years old was 5 μg/dl. 41 the work group approximated that 450,000 children had blood lead levels above that at the time. 42 under the strategy, those children were to be understood as at risk and parents and healthcare professionals would act to address the risk. in 2012, cdc adopted the new approach and 5 μg/dl as a blood lead reference value.43 in may of 2021, the cdc updated it blood lead reference value to 3.5 μg/dl based on nhanes data from 2015–2016 and 2017–2018.44 this action, by cdc, meaningfully advances lead protection based on growing awareness of the risk that lead exposure poses to children at low levels and the evidence that there is no “safe” level of blood lead in children. 45 the new blood lead reference value triggers more protective standards across the public health sector. since its adoption, federal, state, and local governments have adjusted screening levels, practices, and pollution standards. 46 the next section of this ————————————————————————————— 35. id. at 5-6. 36. id. at 2. 37. id. 38. id. 39. id. 40. id. 41. id. 42. id. 43. id. 44. blood lead reference value, ctr. for disease control & prevention, https://www. cdc.gov/nceh/lead/data/blood-lead-reference-value.htm#:~:text=cdc%20uses%20a%20blood %20lead,higher%20than%20most%20children’s%20levels [https://perma.cc/99ep-6n57] (dec. 2, 2022). 45. lead poisoning, world health org. (aug. 11, 2023), https://www.who.int/newsroom/fact-sheets/detail/lead-poisoning-and-health [https://perma.cc/rc2z-bb47]. 46. ruckart pz, jones rl, courtney jg, leblanc tt, jackson w, karwowski mp, cheng py, allwood p, svendsen er, breysse pn. update of the blood lead reference value united https://perma.cc/rc2z-bb47 https://www.who.int/news https://perma.cc/99ep-6n57 https://www 2024] lead: the latest federal actions and 361 best practices article focuses on actions taken by epa, the national leader in setting environmental protection standards for lead and other dangerous contaminants, since 2021. b. epa’s lead strategy in october 2021, following the may cdc determination, epa published its draft lead strategy.47 it followed the draft with a final strategy in october of 2022.48 the final strategy represents the first agency-wide strategy to address the problem of lead. 49 through the use of a “whole of epa approach,” the agency sought to make meaningful progress in reducing both lead exposures and lead related disparities in communities across the nation. 50 the strategy recognizes that lead exposure and its harm to children and communities are not evenly distributed across the country. 51 instead, deep disparities exist in children’s protection from lead exposures. 52 while some commenters thoughtfully focus discussion on disparities at the intersection of race and poverty, parsing out the different sources of lead exposures across communities is also necessary to develop effective public health interventions. 53 children face disparate risk of elevated blood lead levels due to disparate exposure to sources of lead. 54 disparities in lead exposure and its harms exist in rural and urban settings, small towns and big cities, and in every region of the country though the sources of lead and means of exposure may differ. interior lead-based paint and its dust in pre-1978 urban housing accounts for one substantial source of lead across the country. 55 some children living in areas near former lead mines, lead smelters, and other toxic waste sites may not face risks from paint ————————————————————————————— states, 2021. mmwr morb mortal wkly rep. 2021 oct 29;70(43):1509-1512 at 1509, https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8553025/. 47. final strategy to reduce lead exposure and disparities in u.s communities, u.s. env’t prot. agency, https://www.epa.gov/lead/final-strategy-reduce-lead-exposures-and-disparitiesus-communities#:~:text=under%20this%20strategy%2c%20epa%20will,social%20and%20 economic%20well%2dbeing [https://perma.cc/4vy4-xcnr] (feb. 1, 2024) [hereinafter final strategy]. 48. id. 49. id. 50. id. 51. id. 52. see benfer, supra note 22, at 504-05. 53. see health justice strategies, supra note 22, at 146. 54. see benfer, supra note 22, at 505-08 (discussing the relationship between racial discrimination against african americans in housing and lead exposure); see lorraine halinka malcoe et al., lead sources, behaviors, and socioeconomic factors in relation to blood lead of native american and white children: a community-based assessment of a former mining area, 110 env’t health persp. 221, 227-28 (2002) (discussing lead exposure in native american and white children living in former mining areas); see matthew d. ritchey et al., lead poisoning among burmese refugee children--indiana, 2009, 50 clinical pediatrics 648 (mar. 2011) (providing an example of lead poisoning among children living in an immigrant community in fort wayne, indiana). 55. see dignam et al., supra note 3, at 8. https://perma.cc/4vy4-xcnr https://www.epa.gov/lead/final-strategy-reduce-lead-exposures-and-disparities https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8553025 indiana health law review [vol. 21:355 362 at all, and still suffer disproportionate lead exposure and harm. 56 children in areas with poorly maintained drinking water infrastructure may also be exposed to lead in soils in and around their schools, childcare centers, and homes. 57 in other cases, children and pregnant persons may face their primary exposure through imported toys, 58 cosmetic products, 59 spices, 60 candy, 61 or other foods.62 race, income levels, and cultural context all play roles in recognizing and addressing lead exposure disparities. african americans are disproportionately ————————————————————————————— 56. malcoe et al., supra note 56, at 226. 57. see john rumpler & matt casale, env’t am. rsch. & pol’y ctr, get the lead out 9-11 (feb. 23, 2023) (discussing exceedances of federal lead drinking water standards in schools across the country); see michael wines & john schwartz, unsafe lead levels in tap water not limited to flint, n.y times (feb. 8, 2016), https://www.nytimes.com/2016/02/09/us/regulatorygaps-leave-unsafe-lead-levels-in-water-nationwide.html [https://perma.cc/3eat-hdbh] (discussing high lead levels found in tap water in cities and towns in the midwest, east coast, and the south); see erin mccormick et al., revealed: the ‘shocking’ levels of toxic lead in chicago tap water, the guardian (sep. 21, 2022, 3:00 pm), https://www.theguardian.com/us-news/ 2022/sep/21/lead-contamination-chicago-tap-water-revealed [https://perma.cc/a2k3-w2j8] (discussing high lead levels found in water tested in chicago homes); see matt hoffman, high lead levels in drinking water found in 139 san diego child care centers, kpbs (may 25, 2023, 4:18 pm), https://www.kpbs.org/news/local/2023/05/25/high-lead-levels-drinking-water-139san-diego-child-care-centers [https://perma.cc/9c22-pzg7] (discussing high lead levels found in water tested in san diego childcare centers). 58. see robert glatter, the ‘other’ source of lead contamination: your child’s toys, forbes (apr. 26, 2016), https://www.forbes.com/sites/robertglatter/2016/04/26/the-other-sourceof-lead-contamination-your-childs-toys/?sh=22205eaf4f80 [https://perma.cc/76nm-bhbd]; see also roger dobson & ian johnston, toys from the seventies and eighties could be poisoning your children, independent (mar. 22, 2015, 1:00 gmt), https://www.independent.co.uk/news/ uk/home-news/toys-from-the-seventies-and-eighties-could-be-poisoning-your-children-101254 15.html [https://perma.cc/76nm-bhbd]. 59. see ktvl, alert: high levels of lead detected in some traditional cosmetics and spices, ktvl.com, https://ktvl.com/news/local/alert-high-levels-of-lead-detected-in-son metraditional-cosmetics-and-spices [https://perma.cc/e5m6-b5sz] (dec. 12, 2019, 3:43 pm); see also pediatric env’t health specialty units, traditional sources of lead exposures in immigrant populations, univ. of wash., https://deohs.washington.edu/pehsu/sites/deohs. washington.edu.pehsu/files/may%202019/immigrant%20lead%20exposures%20clinicians. pdf [https://perma.cc/urh6-er8d] (aug. 2018). 60. see solcyre burga, why the fda is screening cinnamon imports for lead, time (nov. 17, 2023, 2:14 pm), https://time.com/6336969/fda-applesauce-recall-wanabana-lead-cinnamon/ [https://perma.cc/3xcz-59dk]; see also anna boiko-weyrauch, turmeric poisoned their kids. four seattle-area cases show gaps in lead testing, kuow (jan. 24, 2022, 10:53 am), https://www.kuow.org/stories/turmeric-poisoned-their-kids-four-seattle-area-cases-show-gapsin-lead-testing [https://perma.cc/w5cv-l9e3]; see also ktvl, supra note 61; see also pediatric env’t health specialty units, supra note 61. 61. see laura kurtzman, imported candy at top of contaminated food list in california, ucfs (oct. 25, 2017), https://www.ucsf.edu/news/2017/10/408791/imported-candy-topcontaminated-food-list-california [https://perma.cc/n7fl-5apq]; see also pediatric env’t health specialty units, supra note 61. 62. see alexandra sifferlin, worrisome levels of lead found in imported rice, time (apr. 11, 2013), https://healthland.time.com/2013/04/11/high-levels-of-lead-found-in-imported-rice/ [https://perma.cc/g239-c86x]; see also jonathan taraya, 8 dried plum candies contain ‘unacceptable’ high levels of lead, california warns, ktla, https://ktla.com/news/california/8dried-plum-candies-contain-unacceptable-high-levels-of-lead-california-warns/ [https://perma. cc/bgd3-3s3q] (feb. 11, 2022, 6:47 am). https://perma https://ktla.com/news/california/8 https://perma.cc/g239-c86x https://healthland.time.com/2013/04/11/high-levels-of-lead-found-in-imported-rice https://perma.cc/n7fl-5apq https://www.ucsf.edu/news/2017/10/408791/imported-candy-top https://perma.cc/w5cv-l9e3 https://www.kuow.org/stories/turmeric-poisoned-their-kids-four-seattle-area-cases-show-gaps https://perma.cc/3xcz-59dk https://time.com/6336969/fda-applesauce-recall-wanabana-lead-cinnamon https://perma.cc/urh6-er8d https://deohs.washington.edu/pehsu/sites/deohs https://perma.cc/e5m6-b5sz https://ktvl.com/news/local/alert-high-levels-of-lead-detected-in-son https://ktvl.com https://perma.cc/76nm-bhbd https://www.independent.co.uk/news https://perma.cc/76nm-bhbd https://www.forbes.com/sites/robertglatter/2016/04/26/the-other-source https://perma.cc/9c22-pzg7 https://www.kpbs.org/news/local/2023/05/25/high-lead-levels-drinking-water-139 https://perma.cc/a2k3-w2j8 https://www.theguardian.com/us-news https://perma.cc/3eat-hdbh https://www.nytimes.com/2016/02/09/us/regulatory 2024] lead: the latest federal actions and 363 best practices impacted by lead even at the same income levels of their white counterparts. 63 nationwide, black children suffer from elevated blood lead levels at more than double that of their white counterparts. 64 likewise, poverty correlates with higher levels of lead in all children’s blood. 65 yet, disproportionate exposure and harms cannot and should never be reduced to african american or other children of color living in poverty. african american and other children of color often face disproportionate risks as do white children in low-income communities and all children proximate to lead sources mentioned above. lead has a very local identity in communities that face it and should not be reduced to some generalizations that neglect the range of experiences and exposures that saddle some of our children. beyond its significant ethical, public health, and empirical warrants, the reality of group-based prejudice and implicit bias means decreased motivation for some officials to address problems perceived as outside of the concerns of their constituency. 66 achieving environmental justice and reducing lead disparities and harm requires public policy makers to look to each of these types of disproportionately exposed communities to apply the requisite interventions for primary and secondary prevention. epa’s new strategy to address lead established four straightforward goals: “1. reduce community exposures to lead sources 2. identify communities with high lead exposures and improve their health outcomes 3. communicate more effectively with stakeholders 4. support and conduct critical research to inform efforts to reduce lead exposures and related health risks.”67 this mix of primary and secondary prevention approaches across epa programs reflects the most comprehensive response to lead in the agency’s history. this mixture is bolstered by the unprecedented funding levels given to epa for the elimination of lead from public drinking water service lines and for cleaning up lead and other hazardous contaminants burdening communities in the bipartisan infrastructure law.68 the epa lead strategy begins with a focus on lead sources and the reduction of community exposures—the first best step to protection from lead is its ————————————————————————————— 63. see brandi m. white et al., racial/ethnic differences in childhood blood lead levels among children 72 months of age in the united states, 3 j. racial & ethnic health disparities 145, 145-53 (2016). 64. id. 65. see marissa hauptman et al., individualand community-level factors associated with detectable and elevated blood lead levels in us children results from a national clinical laboratory, 175 jama pediatrics 1252, 1252-60 (2021). 66.see kevin m. drakulich, the hidden role of racial bias in support for policies related to inequality and crime, 17 punishment & soc’y 541, 544-45 (2015); dalton conley, getting into the black: race, wealth, and public policy, pol. sci. q., winter 1999–2000, at 595, 596-97. 67. final strategy, supra note 47. 68. see u.s. env’t prot. agency, bipartisan infrastructure law: a historic investment in water 1, 1-2 (last visited mar. 26, 2024), https://www.epa.gov/system/files/ documents/2021-11/e-ow-bid-fact-sheet-final.508.pdf [https://perma.cc/23jh-vyn2]; see also $30m bil advances superfund cleanup on atlanta’s westside and free epa job training provides skills, job opportunities for 20 local residents, u.s. env’t prot. agency (oct. 10, 2023), https://www.epa.gov/newsreleases/30m-bil-investment-advances-superfund-cleanup-atlantaswestside-and-free-epa-job [https://perma.cc/eu76-wq68]. https://perma.cc/eu76-wq68 https://www.epa.gov/newsreleases/30m-bil-investment-advances-superfund-cleanup-atlantas https://perma.cc/23jh-vyn2 https://www.epa.gov/system/files indiana health law review [vol. 21:355 364 removal from the environment. 69 the next goal of identifying communities facing high exposures and improving their health outcomes serves a critical role in meeting the first goal and centering the wellbeing of community members in the strategy. the third goal manifests a critical instrumental process. communicating with parents, educators, community members, local and state public health and other officials, and across agencies is essential to support the first two goals. the last goal addresses the critical gap awareness of likely and possible lead sources in communities to those currently causing harm. furthermore, this goal encourages the necessary investment in research that better connects environmental and public health interventions with improved health outcomes for communities and their residents. to accomplish these goals the strategy follows a uniform methodology. three distinct approaches serve as guideposts that each relevant epa office addresses with detailed steps followed by measures and metrics: approach 1: reduce lead exposures locally with a focus on communities with disparities and promote environmental justice[.] . . . approach 2: reduce lead exposures nationally through protective standards, analytical tools, and outreach[.] . . . approach 3: reduce lead exposures with a “whole of epa” and “whole of government” approach[.]70 these approaches reflect the recognition of three important aspects of effective lead protection efforts: 1) sources of legacy lead contamination exist in a local context and environment, accordingly environmental remediation and justice require engagement in local communities, 2) current scientific studies make clear that there is no safe level of lead in children’s blood, so past lead protection standards require updating to protect human health, and 3) the authority and responsibility to address lead contamination falls with federal, state, and local governments. substantial efforts to synchronize efforts across institutions and bureaucracies will have to take place to achieve the agencies goals. 71 in the following section, this article highlights programmatic commitments from the strategy and recent developments since its publication in 2022. each highlight falls within a stated objective of the strategy under the purview of a ————————————————————————————— 69. the elimination of lead sources that harm children and adults is the proper goal of public health and environmental protection. achieving that goal requires the continued commitment of federal and state law makers to fund lead abatement in homes, lead cleanups in soils, and lead service line inventory and replacement. without the requisite financial commitments from lawmakers, neither federal nor state agencies have the capacity to eliminate the legacy of lead sources that threaten children. this article focuses on the most recent positive steps to address lead sources seen at the federal and state level. while they fall short of lead elimination, there is meaningful progress to observe and replicate. 70. final strategy, supra note 49. 71. responsibility for and the effective protection of children requires all hands-on deck. it extends to school administrators, healthcare workers, contractors, private landowners, parents, and guardians. epa’s strategy properly recognizes that successful government intervention requires effective coordination across agency programs and across governmental structures. 2024] lead: the latest federal actions and 365 best practices national program office with responsibility for addressing legacy lead sources and/or the promulgation of lead protection standards for lead emissions. while the strategy details multiple efforts within each of the program offices, this section notes a single effort within the four offices chosen that marks a significant development in lead protection efforts “to reduce lead exposures nationally through protective standards”. 72 the offices selected represent the primary regulatory, remediation, and granting offices related to lead within the agency. the actions noted stand out for the substantial impact they will have on national lead source removal or lead protection and in most cases represent improvements explicitly called for by commenters. 73 1. office of air and radiation finding that lead from piston engine aircraft poses an endangerment to human health and the environment “piston-engine aircraft are the largest single source of lead emissions to the air in the u.s., contributing [70%] of the lead entering the air annually,” epa noted when announcing its finding that “lead emissions from certain aircraft engines cause or contribute to lead air pollution that may reasonably be anticipated to endanger public health and welfare under section 231(a) of the clean air act” issued on october 20, 2023. 74 approximately one year earlier, on october 18, 2022, while the agency was finalizing its lead strategy, the epa office of air and radiation issued a proposed endangerment finding under section 231(a) of the clean air act. 75 the proposed finding reflects an important commitment in epa’s final lead strategy. 76 this is largely understated in the strategy where epa states, “epa is evaluating, under the clean air act, whether to make a determination that emissions of lead from aircraft engines that operate on leaded fuel cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare.”77 the proposed finding itself asserted that leaded fuel aircraft emissions caused or contributed ————————————————————————————— 72. final strategy, supra note 47, at 14. a comprehensive analysis and review of the 2022 epa strategy as well as a survey of lead protection efforts across the federal government fall beyond the scope of this article but represent important projects for future lead protection research. 73. see duty to protect, supra note 22 at 27-37 (proposing explicit epa actions to remove lead from air, water, and soil). 74. u.s. env’t prot. agency, epa-420-f-23-022, epa finalizes endangerment finding for lead emissions from aircraft that operate on leaded fuel 1, 1-3 (oct. 2023), https://www.epa.gov/system/files/documents/2023-10/420f23022_0.pdf [https://perma.cc/3r6txh5x] [hereinafter endangerment finding]. 75. id. 76. u.s. env’t prot. agency, 540r22006, epa strategy to reduce lead exposures and disparities in u.s. communities 1, 37 (oct. 27, 2022), https://www.epa.gov/system/files/ documents/2022-11/lead%20strategy_1.pdf [https://perma.cc/8r5v-jxzc] [hereinafter epa strategy]. 77. the agency language does not prejudge the outcome of its proposal before completing the required process of reviewing and responding to the comments received on the proposed finding. id. https://perma.cc/8r5v-jxzc https://www.epa.gov/system/files https://perma.cc/3r6t https://www.epa.gov/system/files/documents/2023-10/420f23022_0.pdf indiana health law review [vol. 21:355 366 to air pollution which posed an endangerment to human health. 78 to appreciate the significance of the proposal, a brief review of prior engagement on the issue provides context. epa’s posted record regarding leaded aviation fuel references a 2003 letter from friends of the earth “raising the issue” and includes a 2006 formal petition sent by earthjustice and golden gate university school of law environmental law and justice clinic on behalf of friends of the earth. the letter and the petition request that epa make a finding of endangerment or in the alternative “commence a study and investigation of the health and environmental impacts of lead emissions from general aviation aircraft.”79 in 2012, then assistant administrator for the office of air and radiation, gina mccarthy, responded that epa would seek public comment on the question and consider the issue further. 80 the record also includes a 2014 request for reconsideration by earthjustice and golden gate university school of law environmental law and justice clinic on behalf of friends of the earth, physicians for social responsibility, and oregon aviation watch, a 2015 response from assistant administrator mccarthy, 81 and a 2021 petition to make a finding of endangerment from leaded aviation fuel sent by earthjustice and golden gate university school of law environmental law and justice clinic on behalf of alaska community action on toxics, center for environmental health, friends of the earth, montgomery-gibbs environmental coalition, oregon aviation watch, county of santa clara, california, town of middleton, wisconsin. 82 in january of 2022, epa administrator michael regan responded to each petitioner by letter stating that epa had completed its necessary data analysis and peer review and intended to issue a proposed ————————————————————————————— 78. proposed finding that lead emissions from aircraft engines that operate on leaded fuel cause or contribute to air pollution that may reasonably be anticipated to endanger public health and welfare, 87 fed. reg. 62,753 (oct. 17, 2022) (to be codified at 40 c.f.r. pts. 87, 1031, 1058). 79. see lynne peeples, aviation fuel’s toxic lead emissions draws lawsuit against epa, mar 12, 2012 available at https://www.huffpost.com/entry/lead-emissions-children-aviationfuel_n_1338131 referencing the letter and petition for rulemaking & collateral relief friends of the earth, october 3, 2006 available at page 1 https://www.epa.gov/sites/default/files/201609/documents/foe-20060929.pdf [https://perma.cc/9s56-zzxu]. 80. letter & memorandum from gina mccarthy, assistant adm’r, u.s. env’t prot. agency, to petitioners, friends of earth et al. (jul. 18, 2012) (on file at https://www.epa.gov/ sites/default/files/2016-09/documents/ltr-response-av-ld-petition.pdf [https://perma.cc/2fpj-63 qh]). 81. epa response letter to friends of the earth, physicians for social responsibility and oregon aviation watch regarding lead emissions from general aviation aircraft (jan. 23, 2015) (on file at https://www.epa.gov/sites/default/files/2016-09/documents/ltr-response-av-ldfoe-psr-oaw-2015-1-23.pdf). assistant administrator mccarthy denied the request for reconsideration but affirmed the agency commitment to investigation through additional air modeling, data collection, and analysis. 82. updated petition from earthjustice et al., to adm’r michael regan, u.s. env’t prot. agency (oct. 12, 2021) (on file at https://www.epa.gov/system/files/documents/2022-01/ aviation-leaded-avgas-petition-exhibits-final-2021-10-12.pdf [https://perma.cc/fu44-lup]). https://perma.cc/fu44-lup https://www.epa.gov/system/files/documents/2022-01 https://www.epa.gov/sites/default/files/2016-09/documents/ltr-response-av-ld https://perma.cc/2fpj-63 https://www.epa.gov https://perma.cc/9s56-zzxu https://www.epa.gov/sites/default/files/2016 https://www.huffpost.com/entry/lead-emissions-children-aviation 2024] lead: the latest federal actions and 367 best practices endangerment finding later that year. 83 this detailed history helps to show the involved iterative process of policymaking and advocacy necessary to secure progress in protecting public health broadly and specifically to protect children from lead. the 2023 endangerment finding reflects overwhelming evidence that leaded fuels from these aircraft increases lead in air in and around these communities with general aviation airports. 84 epa data includes general populations impacted as well as schools and preschool programs. 85 while general population estimates varied based on methods of analysis, epa found that as many as 5,179,000 people lived within 500 meters of a relevant airport facility and that 363,000 of them were children five years old or younger. 86 using a more conservative method, epa data showed that 3,630,000 people lived within 500 meters of a relevant airport runway, including 261,000 age five and under. 87 many schools and preschool facilities are also located near airports of concern. epa found that one hundred and sixty-three thousand children were enrolled in k-12 schools likely impacted by leaded aviation fuel. 88 these communities bear the burden of air emissions from aviation around the country and epa’s support for the finding cites studies indicating that children’s blood lead levels demonstrably increase proximate to relevant airports. 89 one of the cited studies, conducted in michigan, found that children living within a kilometer of a relevant airport were 25% more likely to have blood lead levels above five mg/dl and 45% more likely to have blood lead levels greater than ten mg/dl than children living four or more kilometers from a relevant airport. 90 moreover, the study found that the predicted probability of a child’s blood lead level exceeding five mg/dl living within one kilometer of a relevant airport nearly double based on the increasing volume of piston engine aircraft traffic. 91 the county of santa clara, california, one of the joint petitioners in 2021 requesting that epa make an endangerment finding, also commissioned a study regarding ————————————————————————————— 83. letter from michael s. regan, adm’r, u.s. env’t prot. agency, to petitioners, earthjustice et al. (jul. 18, 2012) (on file at https://www.epa.gov/system/files/documents/202201/ltr-response-aircraft-lead-petitions-aug-oct-2022-01-12.pdf [https://perma.cc/79ba-spph]). 84. see generally u.s. env’t prot. agency, epa-420-r-20-001, national analysis of the populations residing near or attending school near u.s. airports 1, 13-18 (feb. 2020), https://nepis.epa.gov/exe/zypdf.cgi?dockey=p100yg4a.pdf [https://perma.cc/jd8wpygl] [hereinafter national analysis]; see also u.s. env’t prot. agency, epa-420-r-23030, technical support document (tsd) for the epa’s proposed finding that lead emissions from aircraft engines that operate on leaded fuel cause or contribute to air pollution that may reasonably be anticipated to endanger public health and welfare 1, 11-12 (sept. 2023), https://nepis.epa.gov/exe/zypdf.cgi?dockey=p1018jnv.pdfat [hereinafter technical support document]. 85.national analysis, supra note 86, at 13-18. 86. id. at 13. 87. id. at 14. 88. id. at 16. 89. technical support document, supra note 86, at 4. 90. zahran et. al., the effect of leaded aviation gasoline on blood lead in children, 4 j. ass’n env’t & res. economists 575, 605 (2017). 91. id. https://nepis.epa.gov/exe/zypdf.cgi?dockey=p1018jnv.pdfat https://perma.cc/jd8w https://nepis.epa.gov/exe/zypdf.cgi?dockey=p100yg4a.pdf https://perma.cc/79ba-spph https://www.epa.gov/system/files/documents/2022 indiana health law review [vol. 21:355 368 the impact of lead from a local airport. 92 it found: 1) children residing within 0.5 miles of reid-hillview airport present with significantly higher blls than children more distant of reidhillview airport; 2) blls are significantly and substantively higher among sampled children residing east (and predominantly downwind) of reid-hillview airport; 3) the blls of sampled children increase significantly with the volume of measured pistonengine aircraft traffic at reid-hillview airport from the date of blood draw. moreover, the blls of sampled children increase significantly with monthly quantities of aviation gasoline sold to fixed-base operators at reid-hillview airport from the date blood draw.93 the study results, cited by epa and santa clara, county, make clear how significant and necessary epa’s finding is. children and adults residing, attending school, or working near general aviation airports with piston engine aircraft face significant and disparate exposure to lead and the harms it inflicts. 94 addressing these lead exposures extend beyond the reach of all but the federal government. with close to one hundred and seventy-two thousand piston engine aircraft and thousands of general aviation airports across the country, national action by epa was and is essential to protect these communities from associated lead exposures and their adverse consequences. 95 the finding under section 231(a) of the clean air act triggers additional federal action.96 the federal aviation administration is now required to “address the composition or chemical or physical properties of an aircraft fuel or fuel additive to control or eliminate aircraft lead emissions” under its own authorities. 97 based on the finding, epa is likewise required to “propose and promulgate regulatory standards for lead emissions” from piston engine aircraft. 98 administrator regan’s january 2022, letter mentioned above states, “protecting children’s health and reducing lead exposure are two of the epa’s top priorities.”99 the administration’s expeditious movement forward to address this issue certainly reflects a high prioritization. to fulfill this commitment, however, epa will have to move quickly to publish meaningful regulations that ————————————————————————————— 92. mountain data grp., leaded aviation gasoline exposure risk at reid-hilview airport in santa clara county, california i, ii (2021), https://files.santaclaracounty.gov/ migrated/rhv-airborne-lead-study-report.pdf [https://perma.cc/9zrp-qlt3]. 93. id. at 82. 94. technical support document, supra note 86, at 4-5. 95. id. at 7. 96. endangerment finding, supra note 76, at 1-3. 97. id.; see also faa statement on epa finding regarding lead emissions from piston engine aircraft, fed. aviation admin. (oct. 18, 2023), https://www.faa.gov/newsroom/faastatement-epa-finding-regarding-lead-emissions-piston-engine-aircraft [https://perma.cc/nm3m-fsa9]. 98. endangerment finding, supra note 76, at 1-3. 99. letter from michael s. regan, supra note 85. https://perma.cc/nm3m-fsa9 https://www.faa.gov/newsroom/faa https://perma.cc/9zrp-qlt3 https://files.santaclaracounty.gov 2024] lead: the latest federal actions and 369 best practices protect communities impacted by leaded aviation fuel. the endangerment finding reflects approach 2 detailed in the epa strategy to reduce lead exposures and disparities in u.s. communities—reduce lead exposures nationally through protective standards, analytical tools, and outreach. 100 it addresses disparate community exposure to lead and sets up the promulgation of meaningful regulation that will “reduce lead exposures nationally through protective standards.”101 2. office of water lead and copper rule a commitment to addressing lead necessarily extends beyond the air to address lead at all its significant sources. researchers have found that lead in water can have a significant impact on the blood lead levels of children: lead rarely occurs in natural water sources, it contaminates drinking water via the corrosion of lead pipes, solder, faucets, cisterns, and other plumbing components containing lead. exposure to lead from drinking water has been associated with variabilities in children’s blood lead levels (blls). interventions, such as lead pipe replacement, can significantly reduce wlls [water lead levels], and consequently, blls [blood lead levels]. epa estimated that drinking water generally constitutes more than 20% of average daily lead exposure, 40 to 60% for infants who consume mostly infant formula (dry powder or liquid concentrate) mixed with tap water, and up to 80% of children’s daily exposure in some realistic circumstances even in public water supplies (pwss) that are not exceeding epa’s lcr [lead and copper rule]. 102 lead exposure has a cumulative effect on children. 103 even when lead in drinking water is not the primary source, it can have an additive effect along with other sources of harmful lead exposure for children. 104 even small doses of lead can have adverse effects on children. 105 for some children, lead in drinking water represents their primary lead exposure pathway and basis for harmful blood lead levels. 106 ————————————————————————————— 100. final strategy, supra note 49. 101. id. 102. wexin lu et al., lead contamination of public drinking water and academic achievements among children in massachusetts: a panel study, 22 bmc pub. health 1, 1-2 (jan. 15, 2022). 103. see gerard ngueta et al., use of a cumulative exposure index to estimate the impact of tap water lead concentration on blood lead levels in 1to 5-year-old children (montreal, canada), 124 env’t health persp. 388, 388-89 (mar. 2016). 104.see patrick levallois et al., the impact of drinking water, indoor dust and paint on blood lead levels of children aged 1–5 years in montreal (quebec, canada), 24 j. exposure sci. & env’t epidemiology, at 190. (jan. 2013). 105. id. at 190. 106. see hanna-attisha m, lachance j, sadler rc, & champney sa. elevated blood lead levels in children associated with the flint drinking water crisis: a spatial analysis of risk and public health response. am. j. pub. health. 283-90 (2016). indiana health law review [vol. 21:355 370 the flint water crisis illustrated the threat and harm that lead pipes pose to children. 107 since the water crisis, attention, and awareness of the threat that lead poses to drinking water has grown substantially. 108 epa’s lead strategy reflects this increased awareness and concern through commitments included to reduce lead exposure caused by lead service lines.109 in the prefatory remarks regarding lead in water they write: lead exposure through drinking water continues to be a serious risk in many communities, including those facing other environmental justice concerns. . . . there are still 6 to 10 million lsls [lead service lines] in cities and towns across the country. many of these are in communities of color or low-income communities. the biden-harris administration has set a goal of removing 100% of lsls. the bipartisan infrastructure law (bil) will provide a historic $15 billion in funding – the first-ever dedicated federal funding – to address lead in drinking water by replacing service lines and carrying out associated activities that are directly connected to identifying, planning, designing, and replacing lsls. all lsl replacement projects funded by the bil must replace the entire lsl. to address household affordability concerns, epa strongly encourages states to fund the private portion of service line replacements at no additional cost to the homeowner. this means that a significant potential source of lead exposure from drinking water will be eliminated for millions of families. 110 these comments express an intention to see the primary source of lead in water removed. they also acknowledge that communities do not equally suffer the threats of lead exposure in their drinking water. race and socioeconomic status lead to disparate levels of lead exposure—a manifestation of environmental injustice. 111 the remarks also address a longstanding challenge to removing lead from drinking water—if a city replaces the public water lines made of lead who pays to replace the lead lines on privately owned residential property. 112 in the section below, this article highlights two aspects of the epa strategy to reduce ————————————————————————————— 107. michael phillips, in a first, epa survey puts a number on lead pipes around us, associated press, (april 4, 2023, 6:07 pm), https://apnews.com/article/epa-lead-pipes-waterflorida-infrastructure-pfas-55dc1a30936940312778bc5143166e8e. 108. see iris st. meran, heightened awareness about dangers of lead poisoning, spectrum local news, (march 22, 2016, 11:21 pm), https://spectrumlocalnews.com/nys/central-ny/news/ 2016/03/22/heightened-awareness-about-dangers-of-lead-poisoning see also t.r. witcher, how the flint water crisis has impacted us lead-pipe removal efforts, asce, (august 2021), https://www.asce.org/publications-and-news/civil-engineering-source/civil-engineeringmagazine/article/2021/08/how-the-flint-water-crisis-has-impacted-us-lead-pipe-removal-efforts. 109. final strategy, supra note 49, at 24-28. 110. id. at 22. 111. see marissa hauptman et al., supra note 67, at 1253. 112. michael phillis, some cities are digging up water mains and leaving lead pipe in the ground, nbc bos. (july 9, 2023), https://www.nbcboston.com/news/national-international/ some-cities-are-digging-up-water-mains-and-leaving-lead-pipe-in-the-ground/3085114/ [https:// perma.cc/cj6s-ga3l]. https://www.nbcboston.com/news/national-international https://www.asce.org/publications-and-news/civil-engineering-source/civil-engineering https://spectrumlocalnews.com/nys/central-ny/news https://apnews.com/article/epa-lead-pipes-water 2024] lead: the latest federal actions and 371 best practices lead exposures and disparities in u.s. communities from drinking water. 3. office of water lead service line inventory review and replacement guidance in the strategy, epa commits to “implement the lsl [lead service line] inventory requirements in the lcrr [lead and copper rule revisions]. 113 a critical component of those requirements is supporting the local water systems with the authority and responsibility for maintaining the lead service lines. shortly before the issuance of the final strategy, epa acted in this regard by releasing its guidance for developing and maintaining a service line inventory. 114 the document supports water systems with their efforts to develop inventories and to provide states with needed information for oversight and reporting to epa. 115 the guidance provides essential information to help water systems comply with the lead and copper rule revisions requirement to prepare and maintain an inventory of service line materials required by october 16, 2024. 116 successful lead service line removal at minimum requires three basic elements—an accurate inventory of existing lead service lines, the resources for their replacement, the political will in states, cities, and, localities to use available resources for removal. while the lead service line inventory review and replacement guidance could be mistaken for a relatively insignificant component of an agencywide strategy to reduce lead exposures such an assessment would be incorrect. as noted above, most lead exposure in drinking water results from the use of lead service lines. 117 eliminating this source of lead plays a vital role in protecting children from unsafe lead exposures and yet, knowing a task and successfully accomplishing it can very far apart. practical steps, grounded in practice, coordination, education, and communication routinely represent the bridge between achieving environmental goals and setting them. the lead service line inventory review and replacement guidance represents one necessary step along that bridge. localities with the authority and responsibility for drinking water service line maintenance differ drastically in their expertise, resources, capacity, and constituencies. the guidance seeks to place these bodies on a level playing field ————————————————————————————— 113. final strategy, supra note 47, at 27. 114. environmental protection agency, epa 816-b-22-001, guidance for developing and maintaining a service line inventory (2022). 115. id. at 1-2. 116. planning and developing a service line inventory, epa, https://www.epa.gov/groundwater-and-drinking-water/planning-and-developing-service-line-inventory (last updated nov. 6, 2023). [https://perma.cc/x425-3w6z] 117. basic information about lead in drinking water, epa, https://www.epa.gov/groundwater-and-drinking-water/basic-information-about-lead-drinking-water#getinto [https://perma.cc/m7gg-y8n6] (last updated jan. 5, 2024) (lead solder, fixtures, and faucets can still introduce lead into drinking water when lead service lines are not in use. in private drinking water systems from well water, unsafe levels of lead have been traced to these sources where lead service lines are not in use.); see kelsey j. pieper et al., incidence of waterborne lead in private drinking water systems in virginia, 13 j. of water & health 897, 902 (2015). https://perma.cc/m7gg-y8n6 https://www.epa.gov/ground https://perma.cc/x425-3w6z https://www.epa.gov/ground indiana health law review [vol. 21:355 372 to enable them to address the lead service lines in their jurisdictions. most notably, it provides, best practices for inventory development; a readymade inventory template; practical case studies on the development, review, and communication about lead service line inventories; and a discussion on prioritizing the development of inventories in disadvantaged communities and where children spend their time. 118 119since many locales do not have an accurate knowledge of where lead service lines are located, the epa guidance document provides a set of practical steps to develop a reliable inventory. 120 until an accurate inventory is in place, federal resources for their replacement cannot be accessed and children will continue to suffer the risk of exposure. 4. office of water lead and copper rule improvements in the strategy, epa provides: epa is developing a new proposed national primary drinking water regulation (npdwr), the lcri [lead and copper rule improvements], to strengthen the regulatory framework and address lead in drinking water. epa identified the following priority areas for improvement: proactive and equitable lslr [lead service line replacement]; strengthening compliance tap sampling to better identify communities most at risk of lead in drinking water and to compel lead reduction actions; and reducing the complexity of the regulation through improvement of the action and trigger level construct. 121 under approach 2 (reduce lead exposures nationally through protective standards, analytical tools, and outreach), this section presents the epa’s intention to engage in regulatory action regarding drinking water to support primary prevention. this article focuses on the lead and copper rule improvements commitment to “proactive and equitable” lead service line replacement. on november 30, 2023, the epa announced the proposed lead and copper rule improvements. within the proposal, the agency states, “water systems must replace lsls [lead service lines] and certain galvanized service lines regardless of the lead levels occurring in tap or other drinking water samples.” 122 moreover, the rule sets a ten-year timeframe for this to take place. 123 ————————————————————————————— 118. planning and developing a service line inventory, supra note 118. 119. by including a detailed discussion of protecting disadvantaged communities and places with increased risk of children, the epa encourages potential federal funds recipients in addressing the disparate risks that children face. 120. michael phillis, some cities could be left behind on lead pipe replacements, ap news (aug. 26, 2022), https://apnews.com/article/health-michigan-iowa-dubuque-flint-5c47a fcfe8ddb54db5d5176422e7f95c [https://perma.cc/c4ju-qfds]. 121. final strategy, supra note 47, at 26-27. 122. epa, epa-hq-ow-2022-0801, national primary drinking water regulations for lead and copper: improvements (2023). 123. id. at 8. https://perma.cc/c4ju-qfds https://apnews.com/article/health-michigan-iowa-dubuque-flint-5c47a 2024] lead: the latest federal actions and 373 best practices until lead service lines have been removed, they will continue to pose a risk. under the lead and copper rule improvements, epa offers several additional actions to protect communities from the risk these lines pose. the article focuses on two—lowering the lead action level and strengthening protections to reduce exposure.124 the lead action level represents the level at which water systems are required to act to address lead contamination when testing reveals lead exceedances. 125 under the prior rule, the lead action level was 15 µg/l. 126 the proposed lead and copper rule revisions lower the action level down to 10 µg/l. 127 lowering the lead action level to 10 µg/l , is an improvement over the prior lead and copper rule 15 µg/l action level. the lower number directs water systems to address lead exposures that previously were not required. these actions include primary prevention modifications that reduce lead leaching into drinking water. 128 additionally, the proposed rule requires that water systems increase education and notification to consumers related to system work that could impact lead in the service lines, as well as, providing testing results within 72 hours irrespective of the results. 129 the existing rule already requires 24-hour notice to a home that shows a lead action level exceedance. 130 moreover, the proposed rule dictates that systems with “multiple lead action level exceedances…make filters certified to reduce lead available for consumers.”131 for primary and secondary prevention the lead and copper rule revisions above represent significant steps forward in protecting children and adults from lead exposure. 5. office of chemical safety and pollution prevention hazard standards and clearance levels for lead in paint, dust and soil in its 2022 epa strategy to reduce lead exposures and disparities in u.s. communities, the agency committed to revisit the dust lead hazard standards and the dust lead clearance levels, under approach 2, “reduce lead exposures ————————————————————————————— 124. proposed lead and copper rule improvements, epa, https://www.epa.gov/groundwater-and-drinking-water/proposed-lead-and-copper-rule-improvements#:~:text=epa%20is% 20proposing%20to%20require%20water%20systems%20to%20replace%20lead,where%20lead %20service%20lines%20are (last updated jan. 12, 2024) [https://perma.cc/w6ud-zjy9]. 125. james salzman, the past, present and future of the safe drinking water act (2022 revision), 22 ucla pub. l. & legal theory series 1, 12 (2022). (“the standard methodology requires that utilities collect samples from household taps that have not been used for six hours. if more than 10% of the samples exceed the action level (15 ppb for lead), certain water treatment steps become mandatory for the pws.”), https://escholarship.org/uc/item/5dv91837. 126. proposed lead and copper rule improvements, epa (jan. 12, 2024), https://www. epa.gov/ground-water-and-drinking-water/proposed-lead-and-copper-rule-improvements#:~:text =epa%20is%20proposing%20to%20require%20water%20systems%20to%20replace%20lead, where%20lead%20service%20lines%20are. 127. id. 128. epa, national primary drinking water regulations for lead and copper: improvements (sep. 21, 2023) 176-177, https://www.epa.gov/system/files/documents/202311/proposed-lcri_pre-pub-version-11_29_23.pdf. 129. id. at 10-11. 130. id. at 43. 131. id. at 18. https://www.epa.gov/system/files/documents/2023 https://www https://escholarship.org/uc/item/5dv91837 https://perma.cc/w6ud-zjy9 https://www.epa.gov/ground indiana health law review [vol. 21:355 374 nationally through protective standards, analytical tools, and outreach.”132 in describing the lead problem they write: millions of people, especially those living in communities with environmental justice concerns, continue to be exposed to lead at home and in other buildings where lead-based paint is found in deteriorating condition (peeling, chipping, cracking, or damaged). communities that have a high percentage of housing or buildings built before 1978 —and especially those built before 1940 — are at higher risk from historical use of lead-based paint. 133 the issue of lead based related exposure in homes and other buildings falls squarely within the work of many commenters addressing lead. 134 in that regard, lead hazard standards and clearance levels play a fundamental role in the reducing lead exposures under the toxic substances control act. 135 the agency explains the use of the lead hazard standard as the level above which a hazard exists. in describing its use, they write “[[t]he risk assessor will take samples from the building and compare the dust-lead level from the sample to the applicable hazard standards. if the sample is above the standard, then a dustlead hazard is present.”136 the proposed action would change the existing lead hazard standard for dust from 10 micrograms µg/ft² for floors and 100 µg/ft² for window sills to “any level greater than zero reported by an epa-recognized laboratory.”137 the agency grounds the shift to a more protective standard based on “the fact that there is no level of lead in dust that has been found to be safe for children.”138 in conjunction with the revised dust lead hazard standard, epa also committed to revisit the dust lead clearance levels in its 2022 strategy to reduce lead exposures and disparities in u.s. communities. 139 in its 2023 proposal, the agency revises its dust-lead clearance levels from “10 µg/ft² for floors, 100 µg/ft² for window sills and 400 µg/ft² for window troughs to 3 micrograms per square foot (μg/ft²) for floors, 20 μg/ft² for window sills and 25 μg/ft² for window troughs.”140 dust lead clearance levels are used to determine when a lead abatement or removal activity has adequately addressed lead ————————————————————————————— 132. final strategy, supra note 47. 133. id. at 16. 134. see hope kerpelman, supra note 15, at 828; benfer, supra note 22, at 493; emily a. benfer, et al., supra note 22, at 146; ransom, et. al., supra note 23, at 4. 135. 15 u.s.c. § 2683. 136. see epa, epa’s proposal to strengthen dust-lead standards 1, https://www.epa.gov/system/files/documents/2023-07/dlhs%20dlcl%20reconsideration% 20proposed%20rule%20fact%20sheet_0.pdf. 137. see id. 138. epa, biden-harris administration proposes to strengthen lead paint standards to protect against childhood lead exposure (jul. 12, 2023), https://www.epa.gov/newsreleases/ biden-harris-administration-proposes-strengthen-lead-paint-standards-protect-against; see also epa’s proposal to strengthen dust-lead standards, supra note 138, at 2. (epa supports this standard based on “health-only factors.”). 139. final strategy, supra note 47. 140. see epa’s proposal to strengthen dust-lead standards, supra note 138. https://www.epa.gov/newsreleases https://www.epa.gov/system/files/documents/2023-07/dlhs%20dlcl%20reconsideration 2024] lead: the latest federal actions and 375 best practices contamination. 141 after the completion of a lead abatement or removal action, surfaces will be tested to determine whether dust lead has been removed at a level that ensures that any remaining lead dust falls below the dust lead clearance level.142 epa identifies the revised clearance as “the lowest levels epa believes are safe, effective and reliable.”143 6. revised residential soil lead guidance for contaminated sites to further reduce the potential for exposure to lead in soil epa provides a detailed description of the problem of lead in soils. 144 distinct from the more narrowly caused exposure threats in the discussion above, soil lead has many sources. 145 in identifying the problem, epa writes: lead is a naturally occurring element generally found in soil at low levels. in many locations across the united states, however, the concentrations of lead in soils can be much higher because of human activities – especially in and around urban areas, in areas with lead mining and smelting activities, and near older homes with lead-based paint. today, this legacy of lead overburdens communities impacted by the activities of lead producing and using industries; often these are communities of color and low-income neighborhoods. soil-lead contamination can occur from past industrial operations that involved lead, from lead-based paint cracking, flaking, and peeling off homes and buildings, and from past use of leaded gasoline, especially in housing near highways or heavily travelled city streets. lead contamination from the past, often from multiple sources, can accumulate and remain an ongoing threat. children and adults can be exposed to lead in soil and dust through incidental ingestion of contaminated soils by touching their mouth with their hands (typically in young children), but also by adults working in soils or gardening. children may also ingest soil and dust by placing non-food items in their mouths. soil contaminated with lead can be tracked into homes or other buildings, which can result in ingestion of contaminated house dust. in some cases, eating fruits and vegetables grown in leadcontaminated soil is another route of exposure. 146 on june 12, 2023, the epa sent soil lead guidance for hazardous waste ————————————————————————————— 141. id. at 2. 142. id. at 1-2. 143. id. at 3. (epa states that the revised dust lead clearance levels consider factors “such as achievability” in addition to health.). 144. final strategy, supra note 47, at 30. 145. cdc, lead in soil, childhood lead poisoning prevention (dec. 16, 2022), https://www.cdc.gov/nceh/lead/prevention/sources/soil.htm#:~:text=deposits%20from%20leade d%20gasoline%2c%20exterior,and%20homes%20built%20before%201978 [https://perma.cc/fey4-wjyn]. 146. final strategy, supra note 47, at 30. https://perma.cc/fey4-wjyn https://www.cdc.gov/nceh/lead/prevention/sources/soil.htm#:~:text=deposits%20from%20leade indiana health law review [vol. 21:355 376 sites to the whitehouse office of management and budget for review. 147 several months later, on january 17, 2024, epa issued updated residential soil lead guidance for cercla sites and rcra corrective action facilities. the guidance directs agency staff on the proper screening levels for lead found in soils at superfund sites. the prior guidance dated to a 1994 interim guidance memorandum and a 1998 clarification to the 1994 guidance. 148 the new guidance replaces the 1994 guidance based on current scientific understandings that there is no safe level of lead in a child’s blood and the center for disease control’s updated blood lead reference value of 3.5 µg/dl. under the former guidance, residential screening levels were established at a recommended level of 400 ppm for lead in soil for residential land use. 149 lead screening levels provide the basis for determining when soils containing lead require site specific evaluation for potential clean up action. 150 the existing guidance document cites an outdated centers for disease control’s (cdc) blood reference value of 10 µg/dl.151 in the twenty nine years since it was drafted, epa has changed its reference dose on two separate occasions consistent with heightened scientific awareness of the risk that low levels of lead pose to children and that there is no safe level of lead in a child’s blood.152 in order to protect children and adults from lead poisoning, standards and approaches have advanced substantially since epa issued its soil lead guidance in 1994. the updated soil lead guidance represents a critical step forward in protecting children from lead exposure. the new guidance makes two critical improvements to the prior document. it lowers the recommended screening level for lead to 200 ppm generally and to 100 ppm when “an additional source of lead is identified” such as lead based paint or lead water service lines. 153 in discussing the application of the 100-ppm level, the agency explains: the recommended rsl of 100 ppm considers aggregate lead exposure ————————————————————————————— 147. off. of info. and regul. aff., proposed rule for soil lead guidance for hazardous waste sites (jun. 12, 2023), https://www.reginfo.gov/public/forward?searchtarget=reg review&textfield=lead&image61.x=19&image61.y=10 [https://www.reginfo.gov/public/ forward?searchtarget=regreview&textfield=lead&image61.x=19&image61.y=10https://per ma.cc/8fwt-xu9d]. 148. see memorandum: oswer directive: revised interim soil lead guidance for cercla sites and rcra corrective action facilities, epa (aug. 1994) [hereinafter oswer 1994]https://semspub.epa.gov/work/hq/175347.pdf; memorandum: oswer directive: clarification to the 1994 revised interim soil lead (pb) guidance for cercla sites and rcra corrective action facilities, epa (aug. 1998) [hereinafter oswer 1998] https://semspub. epa.gov/work/hq/175346.pdf. 149. oswer 1994, supra note 150, at 3. 150. id. screening levels are defined as a level of contamination above which there may be enough concern to warrant site-specific study of risks. 151. id. at 7. 152. cdc, overview of childhood lead prevention, childhood lead poisoning prevention (oct. 20, 2023) https://www.cdc.gov/nceh/lead/overview.html [https://www. cdc.gov/nceh/lead/overview.htmlhttps://perma.cc/lf2v-cf9u]. 153. updated residential soil lead guidance for cercla sites and rcra corrective action facilities, january 17, 2024, available at https://semspub.epa.gov/work/hq/100003435. pdf100003435.pdf (epa.gov). https://semspub.epa.gov/work/hq/100003435 https://www https://www.cdc.gov/nceh/lead/overview.html https://epa.gov/work/hq/175346.pdf https://semspub https://1994]https://semspub.epa.gov/work/hq/175347.pdf https://www.reginfo.gov/public https://www.reginfo.gov/public/forward?searchtarget=reg 2024] lead: the latest federal actions and 377 best practices and increased risk to children living in communities with multiple sources of lead contamination. in making site-specific decisions on when to use an rsl of 100 ppm, epa regions may use national data sets identified by olem for this purpose. epa regions may also use site-specific sources of information (e.g., data from the local health department or local public water system), alone or in combination with national data sets, to select an appropriate rsl of either 100 ppm or 200 ppm.154 this approach addresses the additive harm faced by children exposed to multiple lead sources—making sure that soil screening levels remain protective for populations with additional lead exposures. 155 in doing so, the epa moves the superfund program forward to reflect the greater scientific understanding of both the adverse impacts of even low levels of blood lead and the additive risks of lead exposure to children from multiple sources. 156 the superfund program represents the nation’s primary program for lead soil removal. in a 2020 bulletin on lead and the superfund program the agency explains: superfund directs epa to clean up contaminated sites where hazardous substances, such as lead, have been released into the environment. lead is one of the most common contaminants found at superfund sites; there are presently over 900 superfund sites with lead as a contaminant of concern. . . . a 2019 epa study of two decades of children’s blood lead levels (blls) in six states indicated that superfund cleanups lowered the risk of elevated bll for children living within 2 km (1.24 miles) of lead-contaminated sites by [8-18%].157 the superfund program conducts remediation at the nation’s most contaminated sites. 158 under the program, cleanup actions are undertaken by the federal ————————————————————————————— 154. updated residential soil lead guidance for cercla sites and rcra corrective action facilities, january 17, 2024, available at https://semspub.epa.gov/work/hq/100003435. pdf.100003435.pdf (epa.gov). 155. id. at6 2. 156. the guidance explains, “as previously stated, evolving science on lead has demonstrated additional adverse impacts of lead exposure well below 10 µg/dl since the 1994 guidance was issued. moreover, children could be exposed to multiple sources of lead other than contaminated soil/dust (e.g., lead water service lines, lead-based paint, or non-attainment areas where the air lead concentrations exceed naaqs) at superfund and rcra corrective action sites. studies conducted at or near superfund sites provide evidence that aggregate lead exposure has generally resulted in blood lead levels that are higher than those of most u.s. children as indicated by the observation of a disproportionate number of elevated blood lead levels in such communities.” id. at 4. 157. epa reduces lead exposures through cleanup enforcement 2020, epa, 1 (nov. 2020) https://www.epa.gov/sites/default/files/2020-11/documents/cleanup-lead-bulletin-2020final.pdf (https://perma.cc/98qj-l3yf). 158.heather klemick et al., superfund cleanups and children’s lead exposure, 100 j. environ. econ. and manage. (mar. 2020) https://perma.cc/98qj-l3yf https://www.epa.gov/sites/default/files/2020-11/documents/cleanup-lead-bulletin-2020 https://semspub.epa.gov/work/hq/100003435 indiana health law review [vol. 21:355 378 government, private parties responsible for contamination, or states. 159 in epa residential lead cleanups, legacy lead contamination is soils is regularly removed from homes and neighborhoods where children play and are exposed. 160 residential lead cleanups often address contamination from legacy lead mining operations and smelters and can involve a large number of residences. 161 superfund cleanups reduce lead exposure using primary prevention through lead removal and secondary prevention through education, community outreach, and coordination with local health agencies; these combined interventions lead to a demonstrable reduction in childhood blood lead levels. 162 the bipartisan infrastructure law directed 3.5 billion dollars to epa for superfund cleanup and reinstated the superfund tax after twenty-five years. 163 as these cleanups tackle old and new sites with legacy lead contamination, the updated soil lead guidance provides an important improvement on prior protections for children under the program. through its updated guidance that considers new scientific knowledge concerning the harmful impacts of lead on children and the availability of resources for cleanup epa can substantially strengthen primary prevention of lead exposure from soils. iii. state policies and programs a. intro – the state role in lead protection as the preceding discussion of federal actions addressing water makes clear, state governments play a critical role in protecting children and others from lead exposure. the billions of dollars of funding for lead service line replacement in the bipartisan infrastructure law depends on state and local government assessment and identification of lines for replacement. 164 in a similar fashion, cdc’s creation of a new blood lead reference value requires state policymakers to adopt that new value in selecting screening levels within their lead testing and ————————————————————————————— 159. see generally, supra note 150. (a discussion of private party lead remediation actions); lead at superfund sites, epa (jan. 17, 2024) https://www.epa.gov/superfund/lead-superfundsites (https://www.epa.gov/superfund/lead-superfund-siteshttps://perma.cc/bkz4-tk6v) (examples of epa funded lead cleanups). 160. heather klemick et al., supra note 160, at 21. 161. one of the country’s largest residential lead cleanups is ongoing at the omaha lead superfund site in omaha, nebraska. “it encompasses 27 square miles of lead contaminated soil around downtown omaha and 42,000 residential properties at the site have been tested for lead. over 13,000 of the approximately 14,000 residential properties that showed high levels of lead concentration have been cleaned up.” epa, supra note 150, at 5. 162. klemick, et al., supra note 160, at 21. 163.bipartisan infrastructure law: environmental remediation at superfund sites, epa https://www.epa.gov/system/files/documents/2022-03/bipartisan-infrastructure-law-fact-sheet_ investments-in-superfund-remedial-program_0.pdf (https://www.epa.gov/system/files/ documents/2022-03/bipartisan-infrastructure-law-fact-sheet_investments-in-superfundremedial-program_0.pdfhttps://perma.cc/7jll-6v58). 164. final strategy, supra note 47, at 1-3. https://www.epa.gov/system/files https://www.epa.gov/system/files/documents/2022-03/bipartisan-infrastructure-law-fact-sheet https://www.epa.gov/superfund/lead-superfund-siteshttps://perma.cc/bkz4-tk6v https://www.epa.gov/superfund/lead-superfund 2024] lead: the latest federal actions and 379 best practices reporting programs to make it effective within their jurisdictions. 165 the analysis and discussion that follows points to best state practices in lead protection programs. as public health professionals and commenters make clear, protecting children from lead exposure requires primary prevention. 166 along with primary prevention efforts, best state practices include testing, reporting, and other secondary prevention methods. 167 the howard ecjc looked across both categories to assess state efforts. preliminary results show that several states have developed robust primary and secondary protection regimes. these states’ leadership provides a roadmap of best practices for consideration and broader adoption. b. children at risk: gaps in state lead screening policies report by safer chemicals, healthy families in 2017, safer chemicals, healthy families published children at risk: gaps in state lead screening policies report. 168 the report focuses on state efforts to screen children suffering from elevated blood lead levels and provides an assessment of best practices in related secondary prevention techniques. 169 the report begins with the affirmation that primary prevention strategies that eliminate sources of lead exposure are the best means to protect children from lead exposure. 170 the report then makes the important point that, “[r]egular blood lead testing is critical for identifying very young children with elevated levels early enough that intervention can prevent or mitigate long-term developmental damage.”171 while blood lead testing does not eliminate or even reduce lead exposure, it does provide valuable information to parents and public health officials. along with robust efforts to eliminate and reduce lead exposure, secondary prevention methods like testing represent an important part of a comprehensive lead protection program. c. husl fifty state review – project description and research methodology in some ways, the howard ecjc survey begins where the children at risk report ends. bringing together an examination of both primary and secondary prevention programs, the project explores both aspects of state protection ————————————————————————————— 165. see jeremy j. michel et al., more guidelines than states: variations in u.s. lead screening and management guidance and impacts on shareable cds development, 20 bmc public health 1, 3-4 (2020), https://bmcpublichealth.biomedcentral.com/articles/10.1186/ s12889-020-8225-8 [https://perma.cc/fyz2-dxaf] (discussing the divergent guidelines regarding lead across states.) 166. emily a. benfer, et al.,, supra note 22, at 13-14. 167. jennifer dickman, children at risk: gaps in state lead screening policies, 1 safer chemicals healthy families 36 (2017), https://toxicfreefuture.org/wp-content/uploads/ 2017/01/saferchemicals.org_children-at-risk-report.pdf [https://perma.cc/w5tn-3t97] . 168. id. 169. id. 170. id. 171. id. https://toxicfreefuture.org/wp-content/uploads https://perma.cc/w5tn-3t97 https://perma.cc/fyz2-dxaf https://bmcpublichealth.biomedcentral.com/articles/10.1186 indiana health law review [vol. 21:355 380 programs to find best practices in state lead protection programs. the project began in 2020 when a talented group of students surveyed the laws and programs across fifty states and the district of columbia. their work began with state websites and state codes to assess each jurisdictions lead protection programs. the project goal was to provide community activists, policy makers, and lawmakers with a comparative evaluation of their jurisdictions lead protection efforts. law and policy analysis grounds the survey and the determination of “best practices” for health protection. the project does not assess the lead risks within each state, the number of children with elevated blood lead levels, compliance with federal lead protection standards across media, nor the number of lead sources that may result in lead exposures.172 d. preliminary findings although the final version of the ecjc survey has not yet been released, the preliminary results provide important insight into what the nation’s most protective lead poisoning prevention programs do. 173 these policies and practices reflect the deliberate efforts by both lawmakers and policy makers to invest resources and attention to this serious issue. these lead poisoning prevention efforts and investments offer substantial dividends when utilized. the elimination of lead exposure in children provides well established benefits to the individual, their families, and the entire community. 174 estimates of the financial benefits of lead elimination reach $84 billion. 175 states derive significant savings from these investments in lower costs over a range of services such as medical care, policing, incarceration, and state medical service costs.176 moreover, states derive the benefits of a higher performing workforce and greater tax revenues over the course of a lifetime. 177 all in all, the investment will pay much more in benefits than it costs. 178 beyond the cold logic of financial investments and returns, states have a responsibility to protect children from known dangers like these. the howard ecjc preliminary survey results illustrate how states can fulfill that duty. through examining what has been done by states and jurisdictions, the article seeks to identify the programmatic mechanisms that move states and their citizens ever closer to the ————————————————————————————— 172. a comprehensive assessment of this type would provide a valuable resource for keeping track of lead and specific exposure risks. 173. howard ecjc fifty state survey available with author. 174. see elise gould, childhood lead poisoning: conservative estimates of the social and economic benefits of lead hazard control, environ health perspectives, env. health perspect. 1162, 1163-1165 (2009) https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2717145/ [https://perma.cc/s3av-3gp4] (discussing benefits of lead hazard controls.) 175. see patrick n. breysse, lead elimination for the 21st century, 25. journal of public health manag. prat. jan., feb. 2019, at 2 at https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc8827389/. 176. gould, supra note 177, at 1163-65. 177. gould, supra note 177, at 1165. 178. breysse, supra note 178. https://www.ncbi.nlm.nih.gov/pmc/articles https://perma.cc/s3av-3gp4 https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2717145 2024] lead: the latest federal actions and 381 best practices elimination of lead hazards to pregnant women and children. the preliminary findings provide a set of best practices in both primary and secondary prevention. primary prevention practices in the survey fall into three categories—reducing/eliminating lead hazards in facilities; training and certification for lead abatement providers; and reducing led exposures in pre1978 residential rental properties. 179 secondary prevention practices have been divided into several key categories. these findings update some of the testing results from the safer chemicals for healthy children report, but also examine reporting requirements, policies to prevent retaliatory evictions, case management services for children with elevated blood lead, and the existence of a state lead protection program to coordinate and oversee efforts. 180 e. primary prevention 1. restrict lead hazards in schools, daycares, public buildings, and/or child-occupied facilities the most effective way to protect people from lead exposure is its removal from the environment. 181 the greatest risk of lead exposure for children occurs from infancy to seventy-two months.182 during these ages, even low levels of lead exposure can inflict significant developmental harms to children. 183 accordingly, eliminating lead exposure for children at early ages produces substantial health benefits. 184 since young children spend most of their time in a small number of places, assessing and eliminating or reducing lead in these environments provides significant benefits in reducing lead exposure overall. states leading in these efforts have developed legal requirements for lead hazard reduction in residential dwellings and child occupied facilities. 185 abatement efforts that address the primary environmental sources of lead--paint, dust, plumbing, and soil offer the most effective environmental protection regimes. 186 the fifty state survey showed that states use a range of approaches to address lead hazards. some provide funding for residential abatement efforts by low————————————————————————————— 179. howard ecjc fifty state survey available with author. 180. howard ecjc fifty state survey available with author. 181. benfer, supra note 22, at 13-14. 182. childhood lead poisoning prevention: health effects of lead exposure, centers for disease control and prevention (sep. 2, 2022), https://www.cdc.gov/nceh/lead/prevention/ health-effects.htm#:~:text=the%20health%20effects%20of%20exposure,still%20developing% 20and%20growing%20rapidly [https://perma.cc/y6h4-advq]. see also richard rabin, warnings unheeded: a history of child lead poisoning, 79 am j. of pub. health 1668, 167273 (1989). 183. joel t. nigg et al., low blood lead levels associated with clinically diagnosed attention-deficit/hyperactivity disorder and mediated by weak cognitive control, 63 biological psychiatry 325, 331 (2008) (author’s manuscript). 184. 10 policies to prevent and respond to childhood lead exposure, pew (aug. 30, 2017) https://www.pewtrusts.org/en/research-and-analysis/reports/2017/08/10-policies-to-prevent-andrespond-to-childhood-lead-exposure [https://perma.cc/kr93-hqrw]. 185. howard ecjc fifty state survey available with author. 186. malcoe, supra note 56, at 226. https://perma.cc/kr93-hqrw https://www.pewtrusts.org/en/research-and-analysis/reports/2017/08/10-policies-to-prevent-and https://perma.cc/y6h4-advq https://www.cdc.gov/nceh/lead/prevention indiana health law review [vol. 21:355 382 income families, while others set a requirement for rental property owners and other child occupied facilities. 187 the fifty state survey found that in some states, lead in plumbing and lead paint are the focus and in others only lead dust, lead paint, and lead in soils are addressed. 188 the best practices, however, in primary prevention address lead across all four primary sources of exposure in child occupied facilities and includes funding for low income residents and low income housing and enforcement programs to ensure that children are protected in the spaces where they spend time. 2. offer training and certification program for lead abatement service providers lead abatement activities represent the mechanism for lead removal in homes. 189 they should be distinguished from renovation, repair, and painting activities.190 lead abatement “is a specialized activity designed to address lead in the home.”191 to ensure that these services are carried out by well-trained and prepared contractors, epa-authorized states offer training and certification programs. 192 these programs train contractors on the pre-1978 housing and child-occupied facilities. 193 they include scientifically based protocol and procedures for lead inspection, assessment, and removal. 194 lead inspection and abatement activities that are improperly conducted pose a substantial threat to children, as they may fail to properly identify the presence of hazards and effectively remove them safely. 195 ————————————————————————————— 187. illinois and iowa, respectively. howard ecjc fifty state survey available with author. 188. howard ecjc fifty state survey available with author. 189. see epa’s proposal to strengthen dust-lead standards, env’t prot. agency https://www.epa.gov/system/files/documents/2023-07/dlhs%20dlcl%20reconsideration% 20proposed%20rule%20fact%20sheet_0.pdf [https://perma.cc/pz9e-hlds] (last visited jan. 23, 2024). 190. lead abatement versus lead rrp, epa (june 6, 2023), https://www.epa.gov/lead/leadabatement-versus-lead-rrp [https://perma.cc/b6nu-fcu5]. 191. id. 192. certification in states without authorized programs must be issued by epa. see leadbased paint abatement and evaluation program, united states environmental protection agency (dec. 19, 2023), https://www.epa.gov/lead/lead-based-paint-abatement-and-evaluationprogram-overview [https://perma.cc/v6xj-j69z]. 193. id. 194. see epa’s proposal to strengthen dust-lead standards, united states environmental protection agency, 2, https://www.epa.gov/system/files/documents/202307/dlhs%20dlcl%20reconsideration%20proposed%20rule%20fact%20sheet_0.pdf [https://perma.cc/zje9-tfw3] (last visited jan. 19, 2024). 195. see greg b. smith, nycha falsely certified this brooklyn child’s apartment leadfree. now he has lead poisoning — and he’s not alone, the city (jan. 11, 2021), https://www.thecity.nyc/2021/01/11/nycha-falsely-certified-brooklyn-child-apartment-lead-free/ [https://perma.cc/s27b-46nt]. see also report says nycha violated lead paint regulations since at least 2013, abc (dec. 10, 2020), https://abc7ny.com/nycha-report-lead-paintregulations-nyc-public-housing-new-york-city-authority/8667776/ [https://perma.cc/fr9dlb36], for discussions of failures by the new york city housing authority and its impacts on residents. https://perma.cc/fr9d https://abc7ny.com/nycha-report-lead-paint https://perma.cc/s27b-46nt https://www.thecity.nyc/2021/01/11/nycha-falsely-certified-brooklyn-child-apartment-lead-free https://perma.cc/zje9-tfw3 https://www.epa.gov/system/files/documents/2023 https://perma.cc/v6xj-j69z https://www.epa.gov/lead/lead-based-paint-abatement-and-evaluation https://perma.cc/b6nu-fcu5 https://www.epa.gov/lead/lead https://perma.cc/pz9e-hlds https://www.epa.gov/system/files/documents/2023-07/dlhs%20dlcl%20reconsideration 2024] lead: the latest federal actions and 383 best practices 3. adopted policies to reduce lead exposure in pre-1978 residential rental properties states with robust lead protection programs that focused on protecting children also recognized the challenge of addressing lead in rental units. 196 in 1992, congress passed the lead disclosure rule to address the threat of lead for persons leasing or buying pre-1978 housing.197 while the rule requires disclosure of lead hazards in rental housing, it does not mandate that hazards be abated. 198 preliminary results of the howard ecjc fifty state survey show that some states move beyond federally required disclosures of lead in rental property to require removal of identified lead hazards. 199 however, some only do so after a child has tested positively for elevated blood lead levels. 200 as benfer and other commenters point out, preventing children from being lead poisoned requires lead abatement before a child suffers the harms of elevated blood lead levels. 201 the best practice by states require the abatement of lead hazards for landlords of pre-1978 housing without the precondition of elevated blood lead levels in one or more children. 202 iv. conclusion unlike many other debilitating childhood diseases, lead poisoning is fully preventable. 203 it results from the introduction of lead into the human environment in consumer products, industrial activities, and mining. 204 its sources are known, and its remediation achievable. the harm it causes is ————————————————————————————— 196. david e. jacobs, et al., the prevalence of lead-based paint hazards in u.s. housing, 110 env’t. health persp. 602 (2002). https://ehp.niehs.nih.gov/doi/epdf/10.1289/ehp. 021100599 [https://perma.cc/p2xb-ag7v]. 197. the lead disclosure rule, us housing and urban dev., https://www. hud.gov/program_offices/healthy_homes/enforcement/disclosure [https://perma.cc/6hgf-38 qg] (last visited jan. 19, 2024). 198. epa hud fact sheet: epa and hud move to protect children from lead-based paint poisoning; disclosure of lead-based paint hazards in housing, united states environmental protection agency, 2, https://www.hud.gov/sites/documents/doc_ 12351.pdf [https://perma.cc/t43r-5y6g] (last revised dec. 1996). 199. for example, california, the district of columbia, illinois, and iowa all require abatement of identified lead hazards in rental housing. howard ecjc fifty state survey available with author. 200. illinois and iowa do not require lead hazard identification or abatement until a child who visits or resides in the premises has tested positively for elevated blood lead levels. howard ecjc fifty state survey available with author. 201. emily a. benfer, et al., supra note 22, at 14. 202. an overwhelming majority of states fall into one of three tiers. tier one states require lead mitigation or abatement by landlords after hazard identification by a certified inspector. tier two states require lead mitigation or abatement by landlords after a positive screening for elevated blood lead levels. tier three states only require that landlords disclose identified lead hazards that are consistent with federal environmental protection standards. 203. benfer, supra note 22, at 497. 204. dignam et al., supra note 3, at 2. https://perma.cc/t43r-5y6g https://www.hud.gov/sites/documents/doc https://perma.cc/6hgf-38 https://hud.gov/program_offices/healthy_homes/enforcement/disclosure https://www https://perma.cc/p2xb-ag7v https://ehp.niehs.nih.gov/doi/epdf/10.1289/ehp indiana health law review [vol. 21:355 384 devastating, long lasting, and even life threatening. our failure to address lead poisoning is a matter of will and commitment. this article points out federal and state actions that reflect the political will and financial commitment to broaden and deepen the protections available until we have the will and commitment to eliminate the threat that lead poses. while these measures fall short of complete cures or solutions, they do matter. they all reduce lead exposure and represent positive steps forward to build upon. they only occurred because of substantial amounts of time, effort, and sacrifice at multiple levels. those responsible for them deserve acknowledgment and recognition for what they have achieved. the epa lead strategy goes far beyond the handful of provisions discussed above. as a comprehensive strategy, it advances the agencies overall protection of children from lead through a “whole of epa” approach. by addressing lead reductions in the air, water, soil, in the homes, and other places where young children spend the most time, the strategy promises an agencywide result that is greater than the sum of its parts. epa’s strategy to reduce lead exposures and disparities in u.s. communities warrants a more in depth and extensive analysis, including attention to its approach to environmental justice and its commitment to collaboration with federal and state agencies. at the federal level, epa’s discussion of collaboration makes sense. it shares responsibility to address the lead risks in the environment with several other federal actors. the federal aviation administration, the consumer product safety commission, the department of health and human services, and the department of housing and urban development for example have significant roles to play in protecting children and others from harmful lead exposures. future research examining actions by these and other agencies across the federal government would provide valuable insight into additional progress at the federal level. commenters have frequently noted hud’s shortcomings in protecting children in its own facilities, and news stories abound describing local housing authorities’ failures to meet state and federal requirements in protecting children in public housing—some of our children most at risk for elevated blood lead levels. at the state level, best practices of primary prevention make important improvements in the health of children by reducing lead in their environments. the howard university school of law fifty state survey of lead protection programs details the substantial investment in lead protection programs that some states have made. the goal of the survey is to provide activists and policymakers with information about the best practices seen in lead protection programs and how their states measure up. the goal of eliminating lead hazards from the environment remains firmly in place and attainable. history shows that progress toward it has come through incremental actions across a range of potential exposures and risks like those discussed above. 205 as children’s blood lead levels have been lowered across the last several decades, continued scientific research has revealed that there is no safe level of lead in a child’s ————————————————————————————— 205. id. 2024] lead: the latest federal actions and 385 best practices blood. 206 the thoughtful policymaking decisions of the past that resulted in the substantial reduction of average blood lead levels for children are also seen in the best state practices for primary prevention discussed above. 207 activists and state policymakers today who will replicate those thoughtful approaches to protecting children across the country’s states and jurisdictions will continue that legacy of progress that bring us even closer to a lead-free future for children. ————————————————————————————— 206. childhood lead poisoning prevention: overview of childhood lead poisoning prevention, centers for disease control and prevention (oct. 20, 2023), https://www. cdc.gov/nceh/lead/overview.html [https://perma.cc/49td-rhpx]. 207. howard ecjc fifty state survey available with author. https://perma.cc/49td-rhpx https://cdc.gov/nceh/lead/overview.html https://www structure bookmarks eadhe atest ederal ctions and est ractices america’s favorite stimulant: an argument for fda regulatory control over caffeinated products labeled as dietary supplements under the fdca jacob o’donnell* i. introduction americans tend to characterize themselves as “go-getters.” our history indicates nothing less than an infatuation with perseverance, resolve, and accomplishment. at the very least, the drive to pursue and overcome obstacles persists in the lives of americans. a common aid utilized in accomplishing said goals is the consumption of caffeinated beverages and other miscellaneous products. more than ninety percent of americans consume caffeine every day.1 as caffeine intake continues to rise amongst americans, the world health organization (“who”) has determined that caffeine dependence should be considered a clinical disorder.2 this should be a cautionary tale for those who consume high amounts of caffeine on a frequent, mindless basis. what seems to be a sociologically acceptable habit has the true potential to impair one’s cognitive function.3 while caffeine is widely popular and consumed by millions each day, there should be more consideration given to the negative impact caffeine can have on both individuals and society in the modern age.4 this note argues that the lack of regulation surrounding highly caffeinated products, coupled with the lack of awareness surrounding health implications of chronic caffeine consumption, serve as a detriment to individuals and society as a whole. specifically, the lack of regulation for caffeinated dietary supplements may have an impact on higher rates of consumption, children and adolescents included. the implications spurred by automatic, consistent consumption of caffeine at high levels are numerous and can result in long-term health consequences. nonetheless, rather than opting to prohibit caffeine use by consumers and businesses through regulation, a more reasonable and pertinent approach would involve revealing that unmonitored consumption of high levels of caffeine over time can have a harmful effect on an individual’s health and well-being. a proper avenue to address this issue is through proposing an amendment to the federal food, drug, & cosmetic act (“fdca”) enabling the federal drug administration (“fda”) to assert control over the regulation of caffeinated products defined as dietary supplements under the statute.5 the fda, if granted * j.d. candidate, 2023, indiana university robert h. mckinney school of law. 1. steven e. meredith et al., caffeine use disorder: a comprehensive review and research agenda, 3 j. caffeine rsch. 114, 114 (2013). 2. id. 3. id. 4. jon kelly, coffee addiction: do people consume too much caffeine?, bcc news mag. (may 23, 2013), https://www.bbc.com/news/magazine-22530625 [https://perma.cc/w4kj-6cce]. 5. 21 u.s.c. §§ (301)-(399)(i) (1938). 118 indiana health law review [vol. 20:117 authority, could have a significant impact on educating consumers, enabling them to determine which products are best for them and to obtain a greater understanding of their relationship with caffeine and caffeinated beverages. this might be accomplished through requiring companies to list total amounts of caffeine on their products, caution against consumption for children and adolescents, and highlight the potential for detrimental health effects to arise due to chronic consumption via educational labeling. through the adoption of an amendment to the fdca, the fda can play a leading role in evaluating the safety of highly caffeinated products on the market, and accordingly regulate while furthermore broadening society’s understanding of the relationship between caffeine consumption and overall well-being.6 section ii provides relevant background relating to the tradition of caffeine consumption and its striking significance for the development of society across history, including its influence on both the industrial and american revolutions. section iii discusses positive and negative repercussions of caffeine consumption on the human brain. section iv highlights the current status of the fda’s regulatory authority over caffeinated products labeled as food and as dietary supplements under the fdca. section v outlines a proposal for amending the fdca to expand the fda’s regulatory deference over such products and emphasizes the potential benefits of broader regulation for american society. ii. historical background michael pollan, in his audiobook “caffeine”, describes in detail the frequency of usage and influence of caffeine on society throughout history while conducting an experiment in abstinence from the drug for three months.7 the crux of pollan’s work focuses on the question of whether caffeine has been a “boon or bane” to the human species.8 pollan stipulates that the origin of caffeine can be traced back to china circa 1000 b.c., where it was commonly ingested through drinking tea.9 another notable legend concerns an ethiopian farmer who one day discovered his goats acting strangely energized after eating the berries of an arabica plant.10 the goats had eaten berries from an arabica plant which the farmer then took to a monk who is credited with producing the first cup of coffee, although it was more like a stew than a beverage.11 this discovery was paramount, as a primary reason for the widespread popularity of coffee across sovereign borders in earlier times was that it was substantially safer than drinking the water of the time, which was not boiled before consumption.12 moreover, coffee became the antithesis of 6. id. 7. michael pollan, caffeine: how caffeine created the modern world, at 1:0020:00 (2020) (downloaded using audible). 8. id. 9. id. 10. id. 11. id. 12. colleen walsh, how caffeine changed the world, harv. gazette (aug. 20, 2020), 2023] america’s favorite stimulant 119 alcohol, and in some instances, relieved people of the terrible impact of long term alcohol abuse while concurrently promoting a more focused, sober lifestyle.13 the historical significance of caffeine cannot be overstated. rather, caffeine has played an impressive role in inspiring some of history’s most impactful occurrences. both coffee and tea were responsible for the disruption of a previous cycle of human activity, enabling humans to stay awake for longer periods of time and to engage in deep thought as a result of increased focus.14 it is beyond question that the introduction of caffeine in the forms of coffee and tea impacted the development of cultures across the globe. even the renowned philosophies, amongst the minds of voltaire, isaac newton, and simone de beauvoir, drank coffee throughout the day and late into the night.15 as coffee was slowly introduced to europe, it claimed a firm grip on western society.16 the first copycat version of the ottoman coffeehouses appeared in venice, italy, and the first coffeehouse in england opened for business in the early 1650’s.17 coffeehouses like these became centers for discussion and debate in england and were coined as “penny universities” because, for a cheap price, individuals had an opportunity to gain exposure to a vast array of subjects ranging from economics and science to politics and religion.18 the consumption of tea eventually became the norm for the english working class.19 this cheap, plentiful source of caffeine altered the workforce. employees could endure much longer shifts, despite horrific working conditions, with less distraction from hunger due to the satisfaction of sugar.20 “the caffeine in tea helped create a new kind of worker, one better adapted to the rule of the machine. it is difficult to imagine an industrial revolution without it.”21 because england’s societal structure was based on a strict hierarchy, the concept of attending a coffeehouse, and sitting next to people of all social classes https://news.harvard.edu/gazette/story/2020/08/author-michael-pollan-discusses-how-caffeinechanged-the-world/ [https://perma.cc/e69h-7fzh]. 13. id. 14. pollan, supra note 5. 15. jessica pearce rotondi, how coffee fueled revolutions—and revolutionary ideas, hist. (feb. 11, 2020), https://www.history.com/news/coffee-houses-revolutions [https://perma.cc/2a6dysz2]. 16. pollan, supra note 5. 17. id. 18. ben johnson, english coffeehouses, penny universities, historic u.k., https://www. historic-uk.com/cultureuk/english-coffeehouses-penny-universities/ [https://perma.cc/7nr8hjt9] (last visited sept. 30, 2021). 19. michael pollan, the invisible addiction: is it time to give up caffeine?, guardian (july 6, 2021, 1:00 pm), https://www.theguardian.com/food/2021/jul/06/caffeine-coffee-teainvisible-addiction-is-it-time-to-give-up?campaign_id=58&emc=edit_ck_20210712&instance_id= 35007&nl=cooking&regi_id=42668502&segment_id=63243&te=1&user_id=a86e3dc5483352a 25d1448742bdd3931 [https://perma.cc/4wz4-pg9n]. 20. id. 21. id. 120 indiana health law review [vol. 20:117 while engaging in invigorating discussions on controversial subjects was considered radical in comparison to the status quo.22 in a sense this open-minded atmosphere fostered an initial manifestation of the essence of democracy, at least among men.23 embarrassingly, women were forbidden from such environments.24 discussion of revolutionary ideas deliberately put the structures of government and society at risk for intense change.25 a primary example of this potential is rooted in the origins of the american revolution, during which coffee became the staple beverage of the colonists.26 beforehand, however, drinking tea was more commonplace as it was established early on by english colonizers.27 due to the monarchy’s grant of a monopoly to the east india company on the sale and importation of tea, legislative measures such as the stamp act of 1765 and the townshend acts of 1767 were imposed to collect taxes from the colonies.28 even though both the stamp act and the townshend acts were eventually repealed, the monarchy refused to back down on its imposition of the tax on imported tea, which served as a symbol of english control over the colonists.29 subsequently, many colonists began refusing to drink tea out of principle, and others resorted to smuggling dutch tea due to its cheaper quality.30 in response, king george iii imposed the tea act of 1773 in a bold attempt to bail the east india company out of bankruptcy.31 an initial wave of unity amongst the thirteen colonies manifested after the famous boston tea party, as most colonists refused to drink tea and used coffee as the substitute.32 over time it was considered brutally unpatriotic to drink tea.33 even john adams, in a letter to his wife, mentioned that he loved drinking tea, but needed to quit the habit and switch to drinking coffee instead as a true expression of his support for the colonies in their fight for freedom.34 this popular trend continued on throughout the birth of the united states, as an early rendition of the declaration of independence was given at the merchant coffee 22. markman ellis, the coffee house: a cultural history 150, 154 (2004). 23. pollan, supra note 5. 24. id. 25. id. 26. lydia zuraw, how coffee influenced the course of history, nat’l pub. radio (apr. 24, 2013, 3:24 am), https://www.npr.org/sections/thesalt/2013/04/24/178625554/how-coffeeinfluenced-the-course-of-history [https://perma.cc/96k2-c45z]. 27. beth carver wees, coffee, tea, and chocolate in early colonial america, metro. museum art (oct. 2003), https://www.metmuseum.org/toah/hd/coff/hd_coff.htm [https://perma. cc/nm94-vauh]. 28. id. 29. tea act, hist., https://www.history.com/topics/american-revolution/tea-act [https:// perma.cc/mn6l-82tu] (last updated sept. 25, 2019). 30. id. 31. wees, supra note 25. 32. zuraw, supra note 24. 33. id. 34. id. 2023] america’s favorite stimulant 121 house in philadelphia.35 moreover, george washington was one of the first farmers to grow coffee in the united states, at his own home in mount vernon.36 indeed, caffeinated drinks have been pervasive in their influence on history throughout the world, and the united states is no exception. this influence continues in the modern age, although it is evident that its scope has significantly expanded.37 by the time world war ii began, americans were consuming more coffee than ever before as consumption levels increased to about twenty pounds per year for every adult.38 american servicemen were drinking coffee at even higher rates, around thirty-two pounds of coffee per capita per year.39 as the army quartermaster corps attempted to vacuum-seal roasted ground coffee to be shipped to service men overseas, the government back home fluctuated back and forth between different levels of rationing for civilians.40 “in april 1942, the u.s. government limited coffee roasters to seventy five percent of the previous year’s supply. in september the quota was cut to sixty five percent. finally, the office of price administration found it necessary to ration coffee for civilians beginning november 29, 1942.”41 every five weeks civilians were given only one pound of coffee, which emphasizes the strain american soldiers would have endured if they were unable to imbibe on the battlefield.42 caffeine continued to have a daily impact on the lives of americans through world war ii, the rest of the twentieth century, and well into the twenty first century.43 coffee consumption may only be at half the level of the 1940’s, but this can be explained by the various kinds of carbonated, caffeine-heavy drinks that have been popularized since the late twentieth and early twenty first centuries.44 regardless 35. sip sip hurrah! how coffee shaped revolutionary america, am. battlefield tr., https://www.battlefields.org/learn/head-tilting-history/sip-sip-hurrah-how-coffee-shapedrevolutionary-america [https://perma.cc/a33q-n4we] (last updated apr. 15, 2021). 36. id. 37. trenton david, return to regulation: fda, energy drinks, and our youth, 53 hous. l. rev. 1401, 1402-03 (2016). 38. brian lokker, u.s. coffee rationing in world war ii, coffee crossroads, https://www.coffeecrossroads.com/coffee-history/u-s-coffee-rationing-in-world-warii#:~:text=the%20wartime%20rationing%20regulations%20cut%20the%20amount%20of,a%2 0year%2c%20to%20everyone%20over%2015%20years%20old [https://perma.cc/w8t5-uph9] (last updated june 22, 2020). 39. michael haft & harrison suarez, the marine’s secret weapon: coffee, n.y. times (aug. 16, 2013), https://atwar.blogs.nytimes.com/2013/08/16/the-marines-secret-weapon-coffee/ [https://perma.cc/6ejv-yhzt]. 40. id. 41. lokker, supra note 36. 42. cirrelia thaxton, history of coffee in america, study.com, https://study.com/academy/ lesson/history-of-coffee-in-america.html [https://perma.cc/tba7-9t6s] (last visited feb. 7, 2021). 43. id. 44. jean c. buzby & stephen haley, coffee consumption over the last century, u.s. dep’t. agric. (june 1, 2007), https://www.ers.usda.gov/amber-waves/2007/june/coffee-consumptionover-the-last-century/ [https://perma.cc/bb6q-gwqz]. 122 indiana health law review [vol. 20:117 the source, it is apparent that caffeine has impacted history in remarkable ways as humans continue to consume the drug daily and oftentimes mindlessly, without fully understanding the true depth of the health repercussions that may present when consumption of caffeine goes unmonitored. iii. caffeine’s influence on the brain caffeine’s chemical label is 1, 3, 7 trimethylxanthine.45 commonly confused as a nutrient, caffeine is simply a dietary component that operates as a stimulant upon ingestion.46 the chemical is completely absorbed into water and fat molecules within a matter of about forty-five minutes.47 caffeine transcends the blood-brain barrier rather easily, resulting in antagonism of adenosine receptor subtypes and thus inducing caffeine’s stimulating effects.48 absorption through the small intestine in particular enables quick entry into the bloodstream, explaining the felt sense of caffeination.49 the quick hit of dopamine alongside increased levels of mental focus from caffeine are primary reasons for its popularity, especially among groups like employees, students, and adolescents in general.50 although caffeine is extremely popular, research indicates that chronic consumption of caffeine debilitates the central nervous system through the modulation of neuronal pathways.51 common adverse effects associated with caffeine range from mild to severe, with some of the milder effects being insomnia, anxiety, irritability, and increased urination.52 some of the more severe adverse effects of chronic caffeine consumption include hallucinations, psychosis, arrhythmias, seizure, and disorientation, not to mention a plethora of withdrawal effects in the event that one ceases consumption after perpetuating the habit over long periods of time.53 caffeine’s grip on society is as strong, if not stronger, than in the early years 45. caffeine, harv. t.h. chan. sch. of pub. health, https://www.hsph.harvard.edu/ nutritionsource/caffeine/ [https://perma.cc/3dch-g7lt] (last visited oct. 6, 2021). 46. dietary guidelines for americans 2015-2020, u.s. dep’t health & hum. serv. (dec. 2015), https://health.gov/sites/default/files/2019-09/2015-2020_dietary_guidelines.pdf [https://perma.cc/urx4-22wk]. 47. caffeine, supra note 43. 48. justin evans et al., caffeine, statpearls, https://www.ncbi.nlm.nih.gov/books/ nbk519490/ [https://perma.cc/fp5q-4hpc] (last updated dec. 4, 2021). 49. jena hilliard, caffeine and caffeine addiction, addiction ctr., https://www. addictioncenter.com/stimulants/caffeine/ [https://perma.cc/r65r-zym4] (last updated sept. 30, 2021). 50. caroline r. mahoney et al., intake of caffeine from all sources and reasons for use by college students, 38 clinical nutrition 668, 669 (2019). 51. fawaz alasmari, caffeine induces neurobehavioral effects through modulating neurotransmitters, 28 saudi pharmacy j. 445, 446 (2020). 52. evans et al., supra note 46. 53. id. 2023] america’s favorite stimulant 123 of the united states. it naturally exists in coffee, teas, and chocolate, and yet technology has provided ways to insert caffeine into all kinds of beverages and foods as an additive, including but not limited to sports drinks, dietary regulation supplements, alcoholic beverages, soda, bottled water, chewing gum, and protein bars.54 the fda, in a statement concerning the magnitude of caffeine consumption in the united states, admonished wrigley for manufacturing packs of gum which contained an amount of caffeine equal to that of half a cup of coffee, which is an interesting yet potentially harmful development.55 the most common caffeine-containing beverages in north america are coffee and soda, but the united states consumed the most caffeine in the forms of soda, sports drinks, and energy drinks per capita than any other country listed in the euromonitor passport global market database in 2018.56 moreover, children as well as adults partake in large amounts of caffeine consumption.57 because of the popularity of caffeine, many americans may be partaking without recognizing it and find it difficult to avoid the substance completely.58 generally, the fda has noted that 400mg of caffeine per day is an amount that is not associated with dangerous side effects for healthy adults.59 considering that four or five cups of coffee measures up to that limit, depending on the particular size of each cup, there is about 95mg of caffeine on average present in one cup of coffee.60 for context, in a 2014 study where caffeine intake in the united states was estimated based on the weekly caffeine diaries of over 30,000 subjects, consumption was measured at 380 mg/day at the 90th percentile for all ages combined.61 a more comprehensive understanding of this daily 400mg recommendation is necessary. despite the relevant and positive intentions of such a recommendation, 400mg of caffeine intake per day may result in detriments to one’s health depending on an individual’s sensitivity to caffeine.62 for instance, many energy drinks including popular brands like celsius, reign, bang, and 54. james g. hodge et al., the consumable vice: caffeine, public health, and the law, 27 j. contemp. health l. & pol’y 76, 77 (2010). 55. kelly, supra note 4. 56. celine m. reyes & marylin c. cornelis, caffeine in the diet: country-level consumption and guidelines, 10 nutrients 1772, 25 (2018). 57. jennifer l. temple, caffeine use in children: what we know, what we have left to learn, and why we should worry, 33 neuroscience & biobehavioral rev. 793, 793 (2009). 58. hodge et al., supra note 52. 59. spilling the beans: how much caffeine is too much?, fed. drug admin. (dec. 12, 2018), https://www.fda.gov/consumers/consumer-updates/spilling-beans-how-much-caffeine-toomuch [https://perma.cc/6je3-lvlq]. 60. food data central search results, u.s. dep’t of agric. (april 1, 2019), https://fdc.nal. usda.gov/fdc-app.html#/food-details/171890/nutrients [https://perma.cc/x7xn-uj2e]. 61. diane c. mitchell et al., beverage caffeine intakes in the u.s., 63 food & chem. toxicology 136, 136 (2014). 62. spilling the beans: how much caffeine is too much?, fed. drug admin. (dec. 12, 2018), https://www.fda.gov/consumers/consumer-updates/spilling-beans-how-much-caffeine-toomuch [https://perma.cc/6je3-lvlq]. 124 indiana health law review [vol. 20:117 rockstar already consist of 300mg in one serving or one can.63 thus, drinking a product with 30mg of caffeine alongside a cup of coffee or even another energy drink later in the day pushes one well above the 400mg limit. many consumers may be under the impression that their daily caffeine intake is at a safe level simply because nothing bad has ever occurred to them as a result. instead, they may focus on the captivating and energizing effects of caffeinated products and are able to subtly disregard the fda’s daily intake recommendation. however, these patterns are unhealthy and dangerous and are exacerbated when consumer ignorance is factored into the equation.64 a primary issue with such a recommendation is that it is misleading to consumers. a daily caffeine intake of 400mg may not result in dangerous side effects for average adults, but this observation undermines other circumstances that play a significant role in influencing whether or not negative health implications arise. one such relevant circumstance is the time of day when people choose to consume caffeine. ingesting 400mg of caffeine before noon would have different implications than 400mg of caffeine consumed after three o’clock in the afternoon.65 the 400mg itself may not be inherently dangerous, but caffeine consumed in the afternoon hours will likely result in a lack of quality sleep. a prolonged pattern of such a habit, compounded by cravings and numerous withdrawal symptoms, is a recipe for a detrimental effect on daytime functioning.66 it would be facetious to say that caffeine does not provide any benefits whatsoever. indeed, moderate consumption of caffeine will yield hardly any negative side effects short-term.67 the potential health detriments posed by caffeine present themselves when one’s frequency and volume of consumption increase over a longer period of time, especially if these patterns are unbeknownst to or ignored by the consumer.68 similarly, even small amounts of pure caffeine powder can prove to be fatal.69 rather than saying that caffeine alone is harmful, it would be more accurate to say that unchecked, consistent consumption of higher amounts of caffeinated products can result in consequences that 63. james foster, energy drinks with the most caffeine, caffeine informer, https://www.caffeineinformer.com/energy-drinks-caffeine [https://perma.cc/4snr-dpev] (last updated feb. 15, 2022). 64. risks of energy drinks, sutter health, https://www.sutterhealth.org/health/nutrition/ risks-of-energy-drinks [https://perma.cc/qp4l-xkhd] (last visited nov. 10, 2021). 65. christopher drake et al., caffeine effects on sleep taken 0, 3, or 6 hours before going to bed, 9 j. clinical sleep med. 11, 1196 (2013). 66. id. at 1198. 67. 24 remarkable caffeine consumption statistics, health rsch. funding, h t t ps:/ /health researchfunding.org/remarkable-caffeine-con su m pt ion -s t a t is t ics / [https://perma.cc/zxs3-g62k] (last visited oct. 6, 2021). 68. hilliard, supra note 47. 69. pure and highly concentrated caffeine, fed. drug admin., https://www.fda.gov/food/ dietary-supplement-products-ingredien ts/pure-and-h igh ly-concen trated-caffeine [https://perma.cc/p3uc-6nsx] (last updated mar. 30, 2021). 2023] america’s favorite stimulant 125 unfortunately put one’s physical and mental health at risk.70 accordingly, it becomes understandable why energy drinks are so popular amongst adolescents; they are ingesting a large amount of caffeine comparable to two or three cups of coffee in one sitting when they purchase such beverages. this produces a rush of energy far more gripping than the typical cup of coffee would provide. furthermore, these energy drinks are often supplemented with other ingredients meant to work together with caffeine to further stimulate consumers.71 in addition to caffeine, energy drinks may also contain guarana, taurine, glucuronolactone, and other various additives to heighten the stimulant effect of the product.72 “when higher doses of caffeine are combined with these other substances currently blended in ebs (energy beverages), the subsequent effect cannot always be predicted; adverse effects have been reported, including cardiac arrest.”73 thus, the recommendation of 400 mg of caffeine daily by the fda more realistically serves as an indication that consumers should probably stop ingesting caffeine once they have hit the 400mg mark if they do not want to flirt with the possibility of developing caffeine toxicity or even death. this recommendation may give consumers a false sense of security in the face of products that include other ingredients which enhance the effects of caffeine, as well as a general lack of awareness surrounding one’s individual relationship with caffeine and its impact on one’s overall cognitive function. a major way that caffeine can inhibit cognitive function is through its antitiring effects on the brain.74 although caffeine can help one stay awake and simultaneously focus for longer periods of time, ingesting it later in the day can cause a plethora of issues related to hindered sleep quality.75 ingesting caffeine in the afternoon or evening hours “. . . results in you getting fewer hours of sleep, leading you to drink more coffee to make up for your tiredness the next day, creating a vicious cycle that can leave you more fatigued than ever.”76 although caffeine is the most popular drug in the united states as well as the rest of the world, sleep may be the strongest performance enhancer that many disregard.77 in fact, over sixty six percent of adults across the globe refrain from sleeping the recommended amount of eight hours per night.78 furthermore, because the number of americans who get fewer than six hours of sleep per night has 70. hilliard, supra note 47. 71. john p. higgins et al., energy beverages: content and safety, 85 mayo clinic proc. 1033, 1034 (2010). 72. id. at 1034. 73. id. 74. is caffeine boosting or sabotaging your productivity?, entrepreneur (june 12, 2017), https://www.entrepreneur.com/article/295232 [https://perma.cc/8c7m-d5ac]. 75. matthew walker, the best thing you can do for your health: sleep well, guardian (feb. 9, 2019), https://www.theguardian.com/lifeandstyle/2019/feb/09/best-thing-you-can-do-foryour-health-sleep-well [https://perma.cc/5yuv-388s]. 76. entrepreneur, supra note 72. 77. see walker, supra note 73. 78. id. 126 indiana health law review [vol. 20:117 increased from thirteen to twenty percent, caffeine consumption affecting this dangerous cycle may influence widespread social implications such as increased anxiety, depression, irritability, and chronic fatigue.79 research indicates that fatigue in the morning hours may result in higher caffeine consumption, ultimately disrupting subsequent sleeping patterns.80 thus, although caffeine is known to enhance cognitive function and memory in the short term, daily consumers may develop the antithesis of those benefits when their consumption disrupts their sleep cycle each night.81 caffeine can impact how quickly one is able to fall asleep and can furthermore constrict the length of sleep as well as its quality.82 caffeine additionally reduces the amount of slow-wave sleep experienced through the night.83 this slow-sleep stage is associated with deep rest that tends to promote a felt sense of refreshment in the morning hours.84 the habit of relying on caffeine in the morning and throughout the day can develop into a dangerous pattern where one relies on caffeine to keep themselves awake while sacrificing the deep rest provided by sleep which is all the more required for efficient and unhindered cognitive function.85 “caffeine-interrupted sleep can lead to sleep deprivation the following day, which is characterized by fatigue and problems with learning, memory, problem-solving, and emotion regulation.”86 a 2013 study confirmed that caffeine consumption up to as much as six hours before bedtime can decrease time spent asleep throughout the night.87 furthermore, “. . . study participants reported sleeping problems when consuming caffeine at least three hours before bed, but they did not realize their sleep was also disrupted when consuming caffeine six hours before bed.”88 this study indicates that many may misunderstand the relationship they have with caffeine, and in turn how their caffeine consumption impacts the quantity and quality of their sleep. the unhealthy pattern of relying on caffeine for alertness and higher levels of functionality comes with other potential ramifications, such as an increased risk for alzheimer’s and dementia.89 a 2021 study broadened the understanding 79. francis o’callaghan et al., effects of caffeine on sleep quality and daytime functioning, 11 risk mgmt. & healthcare pol’y 263, 266 (2018). 80. id. at 265. 81. id. 82. danielle pacheco, caffeine and sleep, sleep found. (jan. 22, 2021), https://www. sleepfoundation.org/nutrition/caffeine-and-sleep#:~:text=in%20this%20article%20%20%20 b everage% 2 0 % 2 0 ,of% 2 0 tea% 2 0 % 2 0 %2 0 1 4 % 2 0 % e 2 % 8 0 % 9 3 % 2 0 6 0 m g% 2 0 [https://perma.cc/88wq-fvvc]. 83. id. 84. id. 85. see walker, supra note 73. 86. id. 87. christopher drake et al., caffeine effects on sleep taken 0, 4, or 6 hours before going to bed, 11 j. clinical sleep med. 1195, 1198 (2013). 88. pacheco, supra note 80. 89. see severine sabia et al., association of sleep duration in middle and old age with 2023] america’s favorite stimulant 127 of the relationship between the two, confirming based on a large subject pool that those who sleep less than six hours per night in midlife increase their chances of developing late-onset dementia.90 although caffeine may not be the single source of sleep deprivation amongst the general population, it is worth noting that the link between increased caffeine consumption and lack of quality sleep has the potential to wreak havoc on one’s well-being long term. another negative consequence of daily caffeine intake concerns increased risk for the development of anxiety and panic attacks.91 this is, of course, ironic in the context of students who use caffeine as a source of stress management, and to endure many hours of study and exam preparation, et cetera. a notable popculture moment which references the risks of caffeine abuse stems from an episode of saved by the bell, where a student develops an addiction to caffeine pills to meet the demands of her hectic schedule, resulting in a mental breakdown.92 in contrast to scientific evidence which points towards the dangers of repetitious caffeine consumption, this television episode highlights just how easy it is for children and adolescents to repeat the dangerous pattern of relying on caffeine. in 2018 alone, ninety-two percent of students claimed to consume caffeine on a regular basis.93 popular reasons for doing so include “to feel awake (79%); enjoy the taste (68%); the social aspects of consumption (39%); improve concentration (31%); increase physical energy (27%); improve mood (18%); and alleviate stress (9%).”94 moreover, according to a study utilizing dietary recall data from 1999-2010, seventy-three percent of children ranging from ages 2-22 consume caffeine on a daily basis.95 more specifically, “. . . the percentage of consumers increased from 63% among two-to-five-year-old children to ~75% among the older age groups.”96 this is striking, especially considering the broad access children have to caffeinated products like sodas and other energy drinks that tend to be loaded with sugar and additives for the purpose of enhancing the product’s stimulating effects.97 an additional study highlighting the relationship between caffeine and cognitive function of children determined that greater incidence of dementia, 12 nature commcn’s 1, 1 (2021). 90. id. 91. entrepreneur, supra note 72. 92. mara reinstein, how “i’m so excited” became the most ridiculous—and iconic— ‘saved by the bell’ moment, ringer (nov. 24, 2020), https://www.theringer.com/tv/2020/11/ 24/21611425/saved-by-the-bell-jessies-song-im-so-excited-history-reboot [https://perma.cc/e6rdkj9d]. 93. mahoney et al., supra note 48. 94. id. 95. amy m. branum et al., trends in caffeine intake among u.s. children and adolescents, 133 pediatrics 386, 386 (2014). 96. id. 97. william r. perlman, childhood caffeine exposure may negatively affect cognitive functioning, nat’l inst. on drug abuse (april 19, 2021), https://www.drugabuse.gov/newsevents/nida-notes/2021/04/childhood-caffeine-exposure-may-negatively-affect-cognitivefunctioning [https://perma.cc/4uhl-j7cf]. 128 indiana health law review [vol. 20:117 caffeine consumption was associated with worse performance on several cognitive measures, including vocabulary comprehension, inhibitory control, working memory, processing speed, and cognitive flexibility.98 thus, the assumption amongst children and adolescents that caffeine will enable them to perform more efficiently in the face of intense schedules and high demands due to surges of dopamine and energy could be characterized as delusion. mindless and unregulated repetition of caffeine binging can lead to disastrous outcomes stemming from caffeine abuse, which may ultimately lead to outright dependence.99 there seems to be a certain controversy in the scientific community regarding whether or not caffeine is an addictive substance. while caffeine does mimic the effects of amphetamines and cocaine through inducing surges of dopamine in the brain, some scientists claim that it does not induce a large enough disruption in the reward-system balance to be considered addictive.100 however, scientists cannot deny the potential for those who consume caffeine on a consistent basis to develop a dependency on the substance, which can occur rather quickly.101 once an individual begins to consume caffeine on a regular basis, they develop a tolerance.102 this may result in a conditioned habit of caffeine intake in the morning, producing a noticeable wake-up effect.103 as one’s tolerance increases, the larger the amount of caffeine necessary to spark that semi-euphoric state of mind which forces us out of morning grogginess.104 if one were to suddenly cease consumption after increasing their tolerance, they would experience an onslaught of withdrawal symptoms and cravings similar to any other potentially addictive substance.105 withdrawal symptoms can occur within just a few hours after missing one’s regular date with caffeine in whatever form and can be severe for those who consistently ingest high doses.106 these symptoms may include headaches, fatigue, irritability, muscle stiffness, lack of concentration, and insomnia.107 dealing with these symptoms makes it much more difficult for those attempting to quit or change their caffeine routine, resulting in relapse back to their familiar habits despite health concerns linked to chronic caffeine use.108 although the american psychiatric association does not characterize caffeine addiction as a substance use disorder, it does label caffeine 98. id. 99. hilliard, supra note 47. 100. id. 101. id. 102. id. 103. id. 104. id. 105. id. 106. caffeine: how to hack it and how to quit it, clev. clinic, https://my.clevelandclinic. org/health/articles/15496-caffeine-how-to-hack-it-and-how-to-quit-it [https://perma.cc/ja8eh4ch] (last updated dec. 23, 2020). 107. id. 108. hilliard, supra note 47. 2023] america’s favorite stimulant 129 withdrawal symptoms as clinical conditions.109 furthermore, the world health organization recognized caffeine addiction as a clinical disorder in 2012.110 although scientists argue about the technicalities of what constitutes as an addictive substance, it cannot be denied that caffeine dependence in its own right is easily developed and potentially dangerous to one’s health and well-being given the broad access consumers have to highly caffeinated products. the facts of various court cases indicate the dangers of unmitigated consumption of products with a high caffeine content. in lemley v. red bull of north america, the mother of william jacob wade brought multiple claims against red bull when her son consumed an unspecified amount of the product.111 william wade eventually suffered cardiac arrhythmia, aortic dissection, hypertension, and other cardiovascular problems that ultimately led to his death.112 multiple wrongful death claims have been pursued against monster beverage, including two separate cases in 2013.113 anais fournier, at fourteen years old, suffered and eventually died from cardiac arrhythmia upon consuming at least two 24oz. monster energy drinks.114 in this case, dr. ana rubio opined that anais died of caffeine toxicity upon her completion of the autopsy.115 dr. stephen lipshultz, a world renowned cardiologist, believed that monster energy drinks substantially contributed to the conditions which led to anais’ death.116 another complaint, filed in the same year, concerned the death of nineteen-yearold alex morris, who suffered from cardiac arrest after supposedly drinking two cans of monster every day for three years before his death, including the day he died.117 cases against monster beverage corp. have led to scrutiny surrounding the company, but have failed to enforce accountability for their elusive marketing tactics geared towards children and adolescents.118 an additional relevant court case concerns the death of logan stiner, an eighteen-year-old high school student who passed away after ingesting pure caffeine powder advertised as a workout supplement on amazon.119 as previously discussed, one teaspoon of powdered caffeine may contain up to 109. id. 110. id. 111. lemley v. red bull n. am., inc., no. 4:16-cv-080, 2016 wl 7197442 at *1 (s.d. ga. dec. 9, 2016). 112. id. 113. jason gewirtz, second wrongful death suit filed against monster beverage, cnbc, https://www.cnbc.com/id/100843412 [https://perma.cc/88bt-jqam] (last updated june 26, 2013). 114. pls.’ opp’n to defs.’ mot. for summ. j. at 1, crossland v. monster beverage corp., no. ric 1215551, 2015 wl 5162521(cal. super. july 7, 2015). 115. id. 116. id. 117. monster energy drink linked to another teen’s death, lawsuit filed, cbs news (june 26, 2013), https://www.cbsnews.com/news/monster-energy-drink-linked-to-another-teens-deathlawsuit-filed/ [https://perma.cc/as6w-73bx]. 118. id. 119. stiner v. amazon.com, inc., 164 n.e.3d 394, 396 (ohio 2020). 130 indiana health law review [vol. 20:117 twenty-eight cups of coffee’s worth of caffeine; products touted to be “pure” caffeine are highly concentrated, potent, and can result in serious health consequences.120 the court of appeals held that amazon was not liable as a supplier or seller of caffeinated products.121 a more recent instance concerns the death of twenty-one year-old lachlan foote, who put caffeine powder advertised as a dietary supplement in his protein shake after a workout.122 these cases display the potential dangers involved in consuming high amounts of caffeine, or even small amounts of powdered caffeine at a substantially higher potency than the typical dosage present in a soda or a cup of coffee. one 2018 study tallied ninety-two cases where caffeine was established as the only cause of death, and although death due to caffeine intoxication or caffeine toxicity is rare, “. . . unintentional caffeine abuse due to excessive intake of caffeine is relatively frequent and responsible for classical clinical manifestations of overstimulation.”123 it is worth noting that a third of the reported deaths from this study were considered to be suicides, which emphasizes the fact that those who did consume caffeine as a vehicle for suicide knew that the amount consumed in those instances would render their bodies unable to function, resulting in their death.124 this ominous result stems from a process known as ventricular fibrillation, which occurs when the heart’s lower chambers begin to vibrate instead of maintaining their regular contractions, leading to cardiac arrest.125 typically, ingesting up to eighty milligrams of caffeine per liter will likely put one at high risk for ventricular fibrillation and subsequent fatality.126 caffeine, although generally safe for ingestion, can have a remarkable impact on an individual’s state of mind and overall well-being considering all relevant circumstances, most notably caffeine’s influence on our dopaminergic systems.127 caffeine is one of the most commonly studied drugs to this date by scientists and medical professionals due to its history as a commonly consumed drug, previously in the forms of coffee and tea.128 although this research has yielded a greater understanding of caffeine’s chemical breakdown in the body in comparison to other substances, an approach tainted with complacency has 120. pure and highly concentrated caffeine, fed. drug admin., https://www.fda.gov/food/ dietary-supplement-products-ingredien ts/pure-and-h igh ly-concen trated-caffeine [https://perma.cc/p3uc-6nsx] (last updated mar. 30, 2021). 121. stiner, 164 n.e.3d at 396. 122. maggie o’neill, caffeine powder overdose leaves 21-year-old deadhere’s what to know, health, https://www.health.com/nutrition/caffeine-powder-overdose [https://perma. cc/yk77-23qy] (last updated jan. 8, 2020). 123. simone cappelletti et al., caffeine-related deaths: manner of deaths and categories at risk, 10 nutrients 611, 615 (2018). 124. claire sissons, can you overdose on caffeine?, med. news today (jan. 16, 2019), https://www.medicalnewstoday.com/articles/322933 [https://perma.cc/2qh2-mqwu]. 125. id. 126. id. 127. alasmari, supra note 49. 128. pollan, supra note 5. 2023] america’s favorite stimulant 131 become the norm for most individuals. a significant amount of clinical studies show that despite an individual’s knowledge surrounding chronic caffeine use, many are unable to refrain from habits related to caffeine ingestion.129 this can result in a seemingly automatic habit that can persist for long periods of time and can additionally serve as a detriment to one’s health long-term.130 expanding awareness surrounding one’s own relationship to caffeine can correspondingly result in a potential decrease of negative health implications and a greater sense of well-being for society. iv. scope of caffeine regulation the federal administration and the drug enforcement agency both play unique roles in the regulation of caffeine, amongst all other substances, foods, and beverages. congress has given both agencies a specified amount of deference to regulate substances through statutes. the fda is responsible for the enforcement of the federal food, drug, and cosmetic act (“fdca”),131 which “prohibits the introduction or delivery for introduction into interstate commerce of any . . . drug . . . that is adulterated or misbranded.”132 the essence of the fdca centers on protecting consumers from accessing unsafe drugs and various other health products via interstate commerce.133 however, determining the practical effect of legislation is exponentially difficult. the fdca is no exception, as it regulates caffeine as both a drug and a food source.134 the definition of “drug” in the fdca is quite broad and thus encompasses a wide array of products. for purposes of the fdca, the term “drug” includes articles listed in the united states pharmacopeia, the official homeopathic pharmacopeia of the united states, or official national formulary or any of their supplements.135 furthermore, the definition includes articles used to diagnose, cure, mitigate, treat, or prevent disease in man or other animals, as well as articles other than food intended to affect the structure or any function of the body of man or other animals.136 interpretations of fdca language concerning the definition of “drug” are potentially unlimited in comparison to the fdca definition of “food”, which includes articles used for food or drink for man or other animals, chewing gum, and articles used for components of other articles of food or 129. meredith et al., supra note 1. 130. id. 131. 21 u.s.c. §§ (301)-(399)(i) (1938). 132. id. 133. joanna r. lampe, the controlled substances act (csa): a legal overview for the 117th congress, cong. rsch. serv. (feb. 5, 2021), https://crsreports.congress.gov/product/pdf/r/ r45948 [https://perma.cc/d83w-lpsw]. 134. gwendolyn prothro, the caffeine conundrum: caffeine regulation in the united states, 27 cumb. l. rev. 65, 75 (1997). 135. 21 u.s.c. § 321(g)(1) (1938). 136. id. 132 indiana health law review [vol. 20:117 drink.137 speculation and concern regarding the implementation of numerous chemicals in food products has been apparent since at least the 1950s. as a result, congress passed the food additives amendment to the fdca in 1958.138 this amendment defined a “food additive” generally as “any substance the intended use of which results or may reasonably be expected to result . . . in its becoming as component or otherwise affecting the characteristics of any food.”139 this amendment created a scientifically based safety standard which demanded that food additive producers show to a reasonable certainty that no harm will result from an additive’s intended use.140 upon the fda’s evaluation of an additive and the subsequent finding that said additive is safe, it will promulgate regulation procedures which describe how the additive may be used in a safe manner.141 these regulation procedures outline how companies are able to utilize additives in their products on an everyday basis in such a way that even though absolute safety of an additive cannot be fully established, their use in various products can be determined as generally safe for the public.142 another relevant statutory development for caffeine regulation is the gras provision, outlined in section 348 of the fdca.143 gras, or “generally recognized as safe”, is an acronym used to designate exceptions to the definition of food additives.144 this designation applies to substances that would not require formal premarket approval because its safety has already been determined by “. . . a long history of use in food or because the nature of the substances, their customary or projected conditions of use, and the information generally available to scientists about the substances precluded the need for a formal review.”145 the provision also allows for a gras classification based on scientific procedures.146 gras determination further requires qualified experts to evaluate each substance for its intended use and to ensure that information used in its safety evaluation is available to the public in some forum, the most common and frequent being the internet.147 indeed, the fdca does not consider the definitions of “food” and “drug” to be exclusive.148 accordingly if a substance is sold and used a food as well as for treatment or prevention of disease, that substance falls under the umbrella of both “food” and “drug” and is controlled by substantive legislative requirements for 137. 21 u.s.c. § 321(f) (1938). 138. leah s. rosenfeld et al., regulatory status of caffeine in the united states, 72 nutrition rev. 23, 24 (2014). 139. 21 u.s.c. § 348 (2018). 140. rosenfeld et al., supra note 135, at 24. 141. rosenfeld et al., supra note 135. 142. id. at 24. 143. 21 u.s.c. § 348 (2018). 144. rosenfeld et al., supra note 135. 145. id. 146. id. 147. id. 148. prothro, supra note 131, at 75. 2023] america’s favorite stimulant 133 both definitions.149 if a company markets a caffeinated soft drink as soda, it will likely be regulated as a food.150 but if a company markets a product as a soft drink that helps maintain a bodily function such as lowering cholesterol, it will likely be regulated as a drug.151 in the case of caffeine, a feasible approach would be for a company to say that it helps boost cognitive function or enables consumers to become more alert. this is especially confusing and inconsistent for purposes of understanding exactly how caffeine is regulated. “these regulatory classifications are different with respect to ingredient regulation, labeling, and good manufacturing practices.”152 dietary supplement labels must display a supplement facts panel while foods must include a nutrition facts panel.153 that being said, these dietary supplement labels are not required for fda approval, rather a company has to provide the fda with a notification that includes the text of the structure or function claim of the product within thirty days of implementing marketing practices.154 thus, there is a split in the road where caffeine is regulated in different ways dependent upon the definition and purpose of the product in which it resides. a third framework regulates caffeine in over-the-counter pain relievers such as excedrin, midol, and bayer, but is not relevant to the framework which guides regulations for caffeinated foods or dietary supplements because caffeinated over-the-counter drugs undergo the fda’s drug approval process.155 despite the difference in regulation between caffeinated over-the-counter medications and caffeinated foods or dietary supplements, over-the-counter medications that include caffeine are a source which consumers may not consider in their daily caffeine consumption. moreover, there are different policies and procedures utilized for regulating pure caffeine in comparison to caffeine as an additive or a dietary supplement. this is likely due to the differences in potency between pure caffeine and caffeine as an additive or dietary supplement. “a single teaspoon of pure powdered caffeine is roughly equivalent to the amount of caffeine in twenty-eight cups of coffee and a half cup of a typical liquid concentrated caffeine product contains roughly the same amount of caffeine as more than twenty cups of 149. id. 150. id. 151. id. 152. rosenfeld et al., supra note 135. 153. tara couch & allen sayler, dietary supplements vs. foodsa fsma regulatory challenge, nat. products insider (april 30, 2018), https://www.naturalproductsinsider. com/legal-compliance/dietary-supplements-vs-foodsa-fsma-regulatory-challenge [https://perma.cc/e6cu-td8e]. 154. michael shabaka, dietary supplements vs. food: fsma labeling requirements for food manufacturers, manex, https://www.manexconsulting.com/blog/dietary-supplements-vs-foodfsma-labeling-requirements-for-food-manufacturers/ [https://perma.cc/4dz4-k4qb] (last visited feb. 10, 2022). 155. caffeine chart, ctr. for science pub. int., https://www.cspinet.org/caffeine-chart [https://perma.cc/z45z-d8ub] (last visited mar. 13, 2022). 134 indiana health law review [vol. 20:117 coffee.”156 although historically coffee and tea reigned as the most commonly consumed caffeinated products, the scope has been widened as products like energy drinks, energy shots, and highly concentrated caffeine powders and liquids have made their way into the market.157 “energy drinks are flavored beverages containing varying amounts of caffeine and, typically, other additives, such as vitamins, taurine, theanine, carnitine, herbal supplements, creatine, sugars, and guarana, a plant product that naturally contains concentrated caffeine.”158 all of these other additives are included to create a higher stimulant effect in addition to caffeine, constituting a clear difference between energy drinks and the typical caffeinated soda.159 to the detriment of the consumer, many energy drinks that include caffeine-containing ingredients like guarana do not list the actual amount of caffeine in the beverage.160 “if caffeine is listed as part of a ‘proprietary blend,’ then the amount of the blend must be listed, but not the amount of caffeine in the blend.”161 this is misleading to consumers, given that energy drinks already tend to have a higher caffeine content than sodas.162 a historical precursor to the widespread popularity of energy drinks was the introduction of highly caffeinated sodas like jolt cola. jolt was marketed as a high energy soda that contained twice as much caffeine as the regular can of coke, but failed to maintain a grip on consumers as displayed by jolt cola filing for bankruptcy in 2009.163 jolt cola was a beverage concocted by pepsi co. and marketed as an energy drink in the 1990s, its primary ingredient being guarana.164 although neither of these drinks remain on the market today, they were a foreshadowing of the current market where energy drink companies flourish.165 in the light of rising popularity surrounding products with high amounts of caffeine or even small amounts of highly concentrated caffeine, “the potential for 156. fda warns consumers about pure and highly concentrated caffeine, fed. drug admin., https://www.fda.gov/food/dietary-supplement-products-ingredients/fda-warns-consumersabout-pure-and-highly-concentrated-caffeine [https://perma.cc/b77f-7jmv] (last updated apr. 13, 2018). 157. david, supra note 35. 158. denise webb, the truth about energy drinks, 15 today’s dietitian 62, 63 (2013). 159. david, supra note 35. see also john higgins et al., energy drinks: a contemporary issues paper, 17 current sports med. rep. 65, 65 (2018). 160. jon kole & anne barnhill, caffeine content, labeling: a missed opportunity for promoting personal and public health, 3 j. caffeine res. 108, 110 (2013). 161. id. 162. webb, supra note 155. 163. jamie logie, jolt cola: the story of the original energy drink, medium, https:// bettermarketing.pub/jolt-cola-the-story-of-the-original-energy-drink-4d5b9241f9cd [https://perma.cc/c9fd-eq5a] (last visited mar. 16, 2022). 164. pepsi to widen testing of drink made with mystical guarana berry, associated press, https://apnews.com/article/34d756298be0563975d2da80674d63a1 [https://perma.cc/cc8g-nna9] (last visited mar. 16, 2022). 165. logie, supra note 160. 2023] america’s favorite stimulant 135 adverse health consequences should be considered and may be cause for preemptive regulatory action.”166 the fda, however, has minute regulatory power over energy drinks and other miscellaneous products as they are labeled by the fdca as “dietary supplements” as opposed to “beverages” and thus are not subject to the heightened regulation that typical beverages that fall under the fdca’s definition of “food”.167 according to the fda, food additives are meticulously monitored and studied.168 “federal regulations require evidence that each substance is safe at its intended level of use before it may be added to foods. furthermore, all additives are subject to ongoing safety review[.]”169 yet, there is a stark difference in the fda’s approach to dietary supplement regulation requirements. “federal law does not require dietary supplements to be proven safe to fda's satisfaction before they are marketed.”170 rather, after health concerns have presented themselves, the fda evaluates safety for consumption via research and adverse event monitoring.171 products like energy drinks, energy shots, and highly concentrated caffeine powders and liquids fall under the periphery of the “dietary supplement” label.172 generally, dietary supplements are defined as “a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet [.]”173 regulatory classifications for food versus dietary supplements differ from one another in respect to labeling, manufacturing, and ingredient regulation.174 the basis for product classification as a dietary supplement or food is a particular product’s intended use.175 “classification determinations often are determined by information which the manufacturer provides on a specific product’s label or otherwise in accompanying 166. chad j. reissig et al., caffeinated energy drinks a growing problem, 99 drug & alcohol dependence 1-3, 2 (2009). 167. joseph g. hoflander, a red bull instead of a cigarette: should the fda regulate energy drinks, 45 val. u. l. rev. 689, 690 (2011). 168. overview of food ingredients, additives, & colors, fed. drug admin., https://www.fda.gov/food/food-ingredients-packaging/overview-food-ingredients-additivescolors#how [https://perma.cc/njd3-4cne] (last updated feb. 6, 2018). 169. id. 170. fda 101: dietary supplements, fed. drug admin., https://www.fda.gov/consumers/ consumer-updates/fda-101-dietary-supplements [https://perma.cc/h4dl-ybgr] (last updated july 15, 2015). 171. is it really ‘fda approved’?, fed. drug admin., https://www.fda.gov/consumers/ consumer-updates/it-really-fda-approved [https://perma.cc/yb4p-batr] (last updated jan. 17, 2017). 172. 21 u.s.c. § 321 (1938). 173. 21 u.s.c. § 321 (1938). 174. rosenfeld et al., supra note 135. 175. background information: dietary supplements., nat’l inst. health, https://ods.od.nih. gov/factsheets/dietarysupplements-consumer/ [https://perma.cc/vt2b-b6mp] (last updated mar. 11, 2020). 136 indiana health law review [vol. 20:117 literature.”176 therefore, there is a lack of urgency by the fda in terms of oversight for dietary supplements. the fda’s center for food safety and applied nutrition (“cfsan”) is the primary vehicle for regulatory oversight.177 the “fda's efforts to monitor the marketplace for potential ‘illegal’ products (products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events[.]”178 simply put, the fda may not attempt to enforce regulation of such products unless the agency becomes aware of potential danger through its own research or an issue becomes apparent via the news, et cetera. v. proposal for fdca amendment enabling regulation by the fda the categorization of highly caffeinated products as dietary supplements may be an impediment to securing a safer market for consumers that could ultimately diminish the levels and subsequent ramifications of chronic caffeine consumption. the fda is not the only government organization responsible for the regulation of certain products, however, as the drug enforcement administration (“dea”) is given some authority to regulate certain substances in its own right. the dea is given its regulatory deference codified in the controlled substances act (“csa”).179 the csa regulates certain drugs that are deemed to pose a risk of abuse and dependence.180 “[t]he act simultaneously aims to protect public health from the dangers of controlled substances while also ensuring access to controlled substances for legitimate purposes.”181 a primary function of the csa regards the scheduling of controlled substances which are listed out across categories labeled as “schedules”.182 there are five schedules in total, each indicating the level of restriction on production, possession, and distribution as well as consequences for improper handling of a controlled substance.183 accordingly, schedule i substances are controlled the most while schedule v substances are minimally restricted.184 there are numerous avenues available to schedule a substance under the csa. the easiest option requires the action of congress, which is not subject to procedural requirements of 176. id. 177. questions and answers of dietary supplements, fed. drug admin., https://www.fda. gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietarysupplements [https://perma.cc/8fm8-a5jq] (last updated july 22, 2019). 178. id. 179. 21 u.s.c. §§ (801-904) (1970). 180. see lampe, supra note 130. 181. id. 182. id. 183. id. 184. id. 2023] america’s favorite stimulant 137 administrative scheduling.185 congress can pass legislation to place a substance under control, alter a substance’s classification, or remove it from a schedule completely.186 administrative scheduling involves an intricate, complex process that includes input from other federal agencies as well as the public.187 the dea can schedule a substance on its own accord, upon request from health and human services, or upon “the petition of any interested party[.]”188 however, scheduling caffeine as a controlled substance would effectively diminish its ability for sale in the market and thus does not present as a suitable means for accomplishing the goal of expanding awareness of caffeine-related health risks. recognizing the difficulties apparent with expanding regulation of highly caffeinated products via the csa and its drug scheduling processes, a more reasonable avenue towards expanding consumer awareness surrounding would be to expand the fda’s regulatory authority over caffeinated products marketed as dietary supplements through amending the fdca.189 the regulatory framework for caffeinated products is complex. given its worldwide popularity in addition to evidence of various short-term benefits from low to moderate caffeine consumption, it would be unreasonable to suggest regulating caffeine to a point where it is in complete control of the government or even strictly regulated by a federal agency. caffeine is entirely too popular and widely accepted to be controlled in such a restrictive way. however, explicit health consequences due to chronic caffeine consumption warrant some sort of oversight. this note argues that the best avenue for establishing the researchbased narrative that caffeine could be a detriment to one’s health when consumed mindlessly is for congress to amend the fdca to give the fda control over the regulation of caffeinated dietary supplements, with the potential result being a greater awareness surrounding individual relationships with caffeine. a shift in regulatory procedure that could create a safer market for consumers would be for the fda to require companies selling caffeinated dietary supplements to gain their approval before putting their products on the market as opposed to the current regulatory requirements, which do not include formal fda approval. this process would at least ensure that products meet the safety standards of the fda for consumers and could potentially diminish consumption which could lead to major health consequences. specifically, the fda could follow a similar approach to dietary supplements that it takes in approving food additives. this process includes an initial step taken by companies to provide the fda with relevant information that shows that additives are safe for consumption.190 fda experts subsequently review test results conducted by companies to confirm that additives are safe for their intended use.191 in the case 185. id. 186. id. 187. id. 188. 21 u.s.c. § 811(a) (1970). 189. see lampe, supra note 130. 190. fed. drug admin., supra note 136. 191. id. 138 indiana health law review [vol. 20:117 of highly caffeinated dietary supplements, requiring companies to submit tests regarding the safety of substances used in combination with caffeine such as taurine would help mitigate the risk that consumers would be exposed to products that put them in harm’s way. another significant avenue through which the fda could regulate these products is through requiring discrete, educational labeling. scientists have considered the health detriments associated with chronic caffeine consumption and furthermore have proposed a more functional labeling system which effectively communicates to the consumer just what exactly they are consuming.192 dr. naoshi ogawa and dr. hirufumi ueki, through their research on caffeine dependence and abuse, propose specific guidelines which they believe would broaden awareness surrounding not only the caffeine content of products but also the health consequences involved with chronic consumption.193 these guidelines include clearly listing the full amount of caffeine in certain products, cautioning against consumption by infants, children, and adolescents, and stating that chronic caffeine consumption can lead to health risks.194 congress, through the dietary supplement health and education act of 1994 (“dshea”) delegated to the fda the authority to require current good manufacturing practice requirements for dietary supplements.195 otherwise called gmp’s, these manufacturing practice requirements establish minimum standards for manufacturing, packaging, and labeling to ensure the quality of products through the manufacturing process.196 gmp’s, labeling, and adverse event reporting processes for foods differ from processes required for dietary supplements.197 for instance, manufacturers of energy drinks are generally free to market their products either as food or as a dietary supplement.198 this sort of freedom highlights the concern that manufacturers are advertising their products as dietary supplements in order to bypass the regulatory processes required for products advertised as food under the fdca.199 the leeway afforded to manufacturers in this context may allow them to circumvent regulation, but this issue can be supplemented with additions to gmp labeling requirements geared towards effectively informing the consumer. specifically, listing the full amount of caffeine in caffeinated dietary supplements, warning against consumption of caffeine by infants, children, and adolescents, and stating that consistent consumption for long periods of time can result in certain health risks addresses 192. naoshi ogawa & hirofumi ueki, clinical importance of caffeine independence and abuse, 61 psychiatry & clinical neurosciences 263, 263 (2007). 193. id. 194. id. 195. dietary supplement health and education act of 1994, pub. l. no. 103-417, 108 stat. 4325. 196. regulation of dietary supplements, congr. rsch. serv. 1, 5 https://crsreports. congress.gov/product/pdf/r/r43062/6 [https://perma.cc/l488-7kfv] (last updated dec. 16, 2014). 197. id. 198. id. 199. id. 2023] america’s favorite stimulant 139 the issue of consumer ignorance surrounding the adverse health effects of chronic caffeine consumption.200 educational labeling is a realistic option for two primary reasons. firstly, discrete labeling with information regarding caffeine consumption does not prevent consumers from making their own decisions, rather this would serve a purely informative purpose in notifying consumers of potential risks involved with their consumption of certain products. this could be accomplished through explicitly listing the full amount of caffeine on caffeinated goods, cautioning against caffeine consumption by infants, children, and adolescents, and stating that chronic caffeine consumption can lead to health risks.201 this would be comparable to labeling practices utilized for tobacco products, which warn against risks of certain types of cancer and other diseases.202 the fda promulgated rules in 2011 demanding stricter warning labels on smokeless tobacco products.203 among these include the printing of statements like, “warning: this product can cause gum disease and tooth loss”, among others.204 “these changes aim to increase awareness of the health risks associated with smokeless tobacco use and improve the public health.”205 the effectiveness of tobacco-product labels on rates of smoking is consistently debated, yet it is difficult to imagine them as obsolete.206 despite this inquiry, the shift in public perception of smoking since the first half of the twentieth century is evident. just between 2001 and 2011, gallup polls indicate that thirty nine to fifty nine percent of polled americans favored a smoking ban in public places in contrast to the 1980s, when smoking in these areas was commonplace.207 regardless of skepticism concerning the effectiveness of educational labels, a complete lack of an approach should not be maintained while consumers may remain completely misinformed on the negative consequences of caffeine consumption. considering the health implications of long-term caffeine use alongside society’s lack of awareness surrounding such concerns, a pertinent remedy to this issue would be for congress to amend the fdca. the fdca should be amended in a way that enables the fda to mandate that companies comply with specific procedures and requirements for caffeinated dietary supplements. adding a subchapter to 21 u.s.c., chapter 9 would be more fitting, especially given the 200. ogawa & ueki, supra note 189. 201. id. 202. hoflander, supra note 164. 203. jason bardi, cigarette pack health warning labels in us lag behind world, u.c. s.f. (nov. 16, 2012), https://www.ucsf.edu/news/2012/11/104420/cigarette-pack-health-warning-labelsus-lag-behind-world [https://perma.cc/7zlu-gbc2]. 204. family smoking prevention and tobacco control actan overview, fed. drug admin., https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-preventionand-tobacco-control-act-overview [https://perma.cc/xrs8-t3eq] (last updated june 3, 2020). 205. id. 206. see michael k. cummings & robert n. proctor, the changing public image of smoking in the united states: 1964-2014, 23 cancer epidemiol biomarkers prev. 32, 3 (2014). 207. id. 140 indiana health law review [vol. 20:117 existence of a subchapter dedicated to regulating tobacco products. this subchapter should grant a higher level of deference to the fda in its regulatory approach for caffeinated dietary supplements. requiring that the fda execute specific regulatory action may be too much to ask and would likely be dismissed by congress. the alternative would be to simply bestow a general authority on the fda to determine the required regulatory policies and practices for caffeinated dietary supplements. this approach is less overt and may be more appealing to members of congress who would consider supporting such legislation. otherwise, a bill outlining newfound, detailed regulatory practices for dietary supplements alone may never see the light of day. below is a draft of a subchapter granting more deference to the fda: subchapter xi: caffeinated dietary supplements § 400: fda regulatory control of caffeinated dietary supplements: “whereas a dietary supplement includes caffeine as an ingredient or additive, the fda shall have the authority to determine the regulatory procedures of such supplements, including manufacturing, labeling, and testing requirements.” realistic predictions on the outcomes of new legislation are necessary in comparison to lofty, half-baked estimates. if a subchapter consistent with the draft above was implemented, the result would likely be a methodical shift in regulatory procedures for dietary supplements. enabling the fda to assert more control would likely result in various changes while concurrently forcing companies to comply with new policy standards. not only would this be a longwinded process, but it would also cost resources to create a new standard for caffeinated dietary supplement regulation. nonetheless, change has always been costly regardless of its scope. an upside to this approach is that caffeine in foods would still be considered gras for purposes of fda regulation. an attempt to shift regulation for every single product containing caffeine, including food and dietary supplements, would be unwarranted. a tailored approach towards products that garner a higher risk of health implications, however, is reasonable and attainable. adjustments must be made to adapt to an updated approach in terms of manufacturing, labeling, and safety testing requirements. if the goal of this new legislation is to create a safer market for consumers while aiming to expand awareness of their caffeine consumption habits, i postulate that these adjustments are a low price to pay in the long-term given that many may be completely unaware of the parameters of their caffeine usage. vi. fdca amendment practicality considerations realistically, congress may not even consider such a proposal. however, given the health implications of long-term, unmitigated caffeine consumption outlined in this note, it is clear that caffeine can play a significant role in the development of particular diseases like alzheimer’s and dementia.208 the evidence of negative implications of unmonitored caffeine use is clear, yet there 208. sabia et al., supra note 87. 2023] america’s favorite stimulant 141 is no dire situation at hand in which caffeine is a perpetrator of drastic health concerns large enough to spark national debate. despite this, most individuals do not understand caffeine and its chemical properties, much less their actual relationship with the drug and how it might be negatively impacting their health and well-being given the significant role that caffeinated products play in people’s lives. caffeine consumption at high levels coupled with a lack of awareness surrounding other relevant circumstances relating to how caffeine works in the body can potentially turn into a health catastrophe if unmitigated for long periods of time.209 an amendment such as the one outlined above has the potential to create a more conscious consumer when it comes to patterns of caffeine ingestion. regulations regarding labels on caffeinated dietary supplements like energy drinks are pertinent because it would not restrict or prevent companies from selling their products. companies would retain the same level of freedom in its ability to advertise and sell. the only difference would concern the information included on the labels. allowing companies to retain such flexibility in a freemarket economy is essential for a positive outcome in this endeavor. otherwise, congress would be reluctant to pass any such legislation as it could negatively impact businesses and accordingly their willingness to comply with statutory requirements. practically, any sort of legislation that would handcuff businesses should be avoided as it may cause new problems relating to compliance with required regulatory procedures and policies. instead, keeping in mind how essential large businesses are for the economy, it is important to keep business owners happy. an amendment to the fdca enabling the fda to regulate dietary supplements in this manner presents the best of both worlds for consumers and companies, allowing for expanded awareness surrounding chronic consumption of highly caffeinated products while concurrently maintaining economic flexibility for businesses. overall, an amendment to the fdca is the best approach because it refrains from placing too much pressure on congress and businesses, provides the opportunity to expand consumer awareness on caffeine, and maintains a sense of accountability for manufacturers of caffeinated dietary supplements. vii. conclusion despite the pervasiveness and popularity caffeine has held across history and still today, research indicates a plethora of health issues that can arise if caffeine consumption, especially at high levels over long periods of time, goes unmonitored.210 these health ramifications are exacerbated by busy schedules and various other stressful circumstances that can lead consumers into behavior patterns that are detrimental to their overall state of well-being.211 acknowledgement of potential negative implications of caffeine consumption 209. see meredith et al., supra note 1. 210. id. 211. id. 142 indiana health law review [vol. 20:117 cannot be avoided forever. in consideration of this, a certain amount of feasible regulation is necessary if consumer safety is a goal for the united states. amending the fdca to allow the fda to assert its control over the regulation of caffeinated dietary supplements can decrease the possibility for individual health catastrophes, keep companies who disregard the health of their customers in check, and ultimately broaden consumer awareness surrounding the relationship between human beings and their favorite stimulant, caffeine. checking the box-es: attempting to subvert roe kathleen conn* & brianna kovit** abstract this article analyzes the issue of a woman’s right to legalized abortion and state attempts to circumvent the precedential u.s. supreme court decisions recognizing a woman’s right to bodily autonomy, using the state of indiana as a persistent example of such attempts. a woman’s right to legal abortion is a public health concern. protection of legal abortion is found through the right to privacy, a right inferred from several amendments to the united states bill of rights. the supreme court’s inaction in the indiana litigation and more recently, in the texas case, leaves many women who seek abortions with no recourse. i. introduction ever since the trump administration began the appointment of supreme court justices with reputations for conservative views, both legal and social commentators began predicting the high court’s imminent repudiation of roe v. wade.1 the tragic death of justice ruth bader ginsburg intensified the speculation. however, the attempts to overturn roe were in the works decades earlier, with over twenty state legislatures passing laws or putting laws on the books that restricted preand post-viability abortions, chipping away bit by bit at roe in subtle and not-so-subtle ways under the guise of “safeguarding women’s health.”2 the women who stood to be affected by these restrictions included adults, both married and single, as well as school-aged minors whose educations would, in many cases, be terminated by pregnancy. one of the more vigorous and persistent anti-roe campaigns was waged by the state legislature of indiana. this commentary will examine the three latest attempts by indiana to force the court to abandon both roe and planned parenthood of southeastern pennsylvania v. casey.3 part i will describe and analyze two different litigation forays recently mounted by indiana which were vacated and remanded by the high court in light of june medical services v. russo,4 as well as how one court responded to the remand. part ii will examine perhaps the most dangerous anti-roe arguments of the indiana legislature, the * ph.d., j.d., ll.m.; of counsel at the law firm of king, spry, herman, freund & faul, llc, in bethlehem, pennsylvania, and an adjunct professor at muhlenberg college, public health department. ** student at muhlenberg college, allentown, pennsylvania, in the public health department. 1. see roe v. wade, 410 u.s. 113 (1973). 2. abortion policy in the absence of roe, guttmacher inst., https://www.guttmacher.org/ state-policy/explore/abortion-policy-absence-roe [https://perma.cc/a5qc-bqqe] (last updated jan. 13, 2022). 3. see planned parenthood of se. penn. v. casey, 505 u.s. 833 (1992). 4. see june med. services llc. v. russo (june med. 1), 140 s. ct. 2103 (2020). 330 indiana health law review [vol. 19:329 revised statute for disposal of aborted fetal remains and the ban on voluntary selective abortions. part iii will examine the possible relevance of the ban on voluntary selective abortions to the eugenics movement and the high court’s limited reaction to the ban. part iv will analyze whether indiana’s attempts to restrict abortions pose a true challenge to roe and its progeny and attempt to dust off the proverbial crystal ball. ii. indiana’s efforts to restrict women’s access to abortions and june medical a. the eighteen-hour waiting time since 1995, according to the seventh circuit court of appeals,5 the state of indiana law required that, at least eighteen hours before a woman had an abortion, the state would provide the woman information about the abortion procedure, fetal life and development, and alternatives to abortion. the state legislature freely admitted that it provided this information in an attempt to convince the woman to forego the abortion and, by doing so, advance the state’s interest in preserving fetal life. at that time, in addition to providing the information, the state also required that a woman submit to an ultrasound of her fetus and hear the fetal heartbeat, but she could decline either or both, and 75% of women did in fact decline. at this time, the ultrasound was usually performed just before the abortion procedure. however, in july 2016, the indiana house enrolled act 1337 (“hea 1337”) amended the law and added a “timing” mandate, that a woman seeking an abortion have an ultrasound performed at least eighteen hours before the actual abortion procedure, with no opt-out opportunity.6 virtually all abortions in indiana in 2016 occurred at four of the seventeen planned parenthood of indiana and kentucky (“ppink”) health centers, and these centers also had ultrasound facilities. the woman could refuse to view the ultrasound image but had to affirmatively decline to do so on an official state form.7 the ppink centers with ultrasound capability were not open for abortions every day, some only one or three days per week. the eighteen-hour requirement between ultrasound and abortion procedure meant that two visits to one of the centers were necessary, and many women had to travel significant distances, often 100 miles or more, to get to the center, and stay at least overnight in accommodations near the facility.8 most of the women seeking abortions at 5. planned parenthood of ind. and ky., inc. v. comm’r, ind. state dep’t of health, et al. (planned parenthood of ind. & ky., inc. 1), 896 f.3d 809, 812 (7th cir. 2018), reh’g and reh’g en banc denied, oct. 5, 2018. 6. ind. code § 16-34-2-1.1 (2021). 7. planned parenthood of ind. & ky., inc. 1, 896 f.3d at 812. 8. id. at 815. the seventh circuit reported, “for example, women in the second largest city in indiana, fort wayne, must now travel approximately 400 miles over two days to obtain an abortion, as the closest ultrasound machine is 87 miles away in mishawaka (174 miles round trip) 2022] checking the box-es 331 ppink centers were poor, with approximately over half of the women with incomes at or below 200% of the federal poverty line.9 the district court had concluded that the burdens on women seeking abortions were clearly undue when compared to the state’s goals of promoting fetal life and women’s health, and granted ppink’s request for a preliminary injunction.10 the seventh circuit agreed, citing casey11 and whole woman’s health,12 and stated that the eighteen-hour ultrasound requirement before the abortion procedure created an impediment to the women’s access to abortion services, and the lengthy travel necessitated by the time requirement was itself the origin of the burden. the eighteen-hour requirement was, therefore, unconstitutional.13 the seventh circuit then formulated a balancing test where the relevant comparators were the burdens and benefits deriving from the eighteen-hour time required between ultrasound and abortion services in hea 1337. the appellate court listed the burdens involved in the newly enforced waiting period, particularly for poor women seeking abortions, as added travel expenses, childcare costs, loss of wages, risk of job loss, and potential danger from an abusive partner.14 the corresponding benefits, the potential of a woman’s having and/or viewing an ultrasound and reflecting on her decision to proceed with abortion, according to the seventh circuit majority, were “very small.”15 the court concluded that the state presented almost no evidence that the eighteen-hour time requirement produced any discernable effect on advancing the state’s asserted goal of promoting the life of the fetus.16 the commissioner subsequently petitioned for rehearing and rehearing en banc, both of which were denied on october 5, 2018. a petition for certiorari followed on february 4, 2019.17 approximately two months later, on april 23, the case was scheduled for conference on may 9, 2019, but was rescheduled six times before the supreme court granted certiorari. on july 2, 2020, the high court simply vacated the seventh circuit’s decision and remanded the case to the and the nearest abortion providing health center is 115 miles away in lafayette (230 miles round trip).” id. at 819. 9. id. at 815. 10. planned parenthood of ind. & ky., inc. v. comm’r of ind. state dep’t of health (planned parenthood of ind. & ky., inc. 2), 273 f. supp. 3d 1013, 1043 (s.d. ind. 2017). 11. planned parenthood of se. penn. v. casey, 505 u.s. 833, 846 (1992) (the seventh circuit noted at 817-18 that casey defined undue burden as “placing a substantial obstacle in the path of a woman seeking an abortion of a non-viable fetus,” citing casey, 505 u.s. at 876-77). 12. whole woman’s health v. hellerstedt, 136 s. ct. 2292, 2324 (2016) (citing casey, 505 u.s. at 877). 13. planned parenthood of ind. & ky., inc. 1, 896 f.3d at 819, 827. 14. id. at 827. 15. id. 16. id. at 830. 17. see brief for petitioner, box v. planned parenthood of ind. & ky., inc., 2019 wl 446533 (u.s. 2019) (no. 18-1019). 332 indiana health law review [vol. 19:329 seventh circuit for further consideration in light of the high court’s decision in june medical.18 on september 30, 2020, the parties jointly requested the case be remanded to the district court.19 b. the relevance of june medical services, llc v. russo on june 29, 2020, the supreme court decided june medical services, llc. v. russo, in which the members of the court considered a louisiana statute, louisiana act 620, providing that doctors who performed abortions at clinics in louisiana must have active admitting privileges at hospitals within thirty miles of their abortion facilities. this requirement was the mirror image of the texas requirement in whole woman’s health, previously declared unconstitutional by the high court in 2016. five abortion clinics and four abortion providers mounted a pre-enforcement facial challenge to june medical, asking for a temporary restraining order (“tro”) and preliminary injunction (“pi”) to block enforcement of the statute. they argued that, under the casey standard of undue burden, the louisiana statute was also unconstitutional.20 before the district court, the state urged the court to move forward, agreeing that the plaintiffs had standing, even for a pre-enforcement facial challenge.21 the district court examined the similarity of the louisiana and texas statutes and ruled that act 620 was unconstitutional and enjoined its enforcement. the district court later granted a permanent injunction because the law provided no significant health benefits for women.22 a divided court of appeals reversed the district court ruling, stating that the louisiana statute would have “dramatically less impact than the texas statute” previously declared unconstitutional.23 a similarly divided court of appeals then denied a rehearing en banc,24 but left intact the district court’s injunction25 while both parties petitioned for certiorari, which the supreme court granted.26 justice breyer wrote the supreme court decision, joined by justices 18. see june med. 1, 140 s. ct. 2103 (2020). 19. see joint request to remand, planned parenthood of ind. & ky., inc. v. comm’r of ind. dep’t of health, 823 fed. appx. 440 (7th cir. 2020) (mem) (no. 17-1883) (remanded). 20. june med. 1, 140 s. ct. at 2112. 21. id. at 2114 (where the state asserted that “there was ‘no question that the plaintiffs had standing to contest the law’”). 22. id. at 2115. 23. id. at 2116 (citing june med. services, llc v. gee, 905 f.3d 787 (5th cir. 2018)). rebekah gee was secretary of the louisiana department of health and hospitals. stephen russo, interim secretary of the louisiana department of health and hospitals, was substituted for gee as defendant. 24. see june med. services, llc v. gee (june med. 2), 913 f.3d 573 (5th cir. 2019) (per curiam). 25. june med. 1, 140 s. ct. at 2117. 26. june med. services, llc v. gee (june med. 3), 139 s. ct. 663 (2019). 2022] checking the box-es 333 ginsburg, kagan, and sotomayor. the standing issue arose again in the state’s arguments, but the court noted that the state had waived that argument five years prior in the district court, and did not countenance the issue.27 the plurality of the high court members looked to the factual findings of the district court, and found those findings “not clearly erroneous,” and therefore, controlling.28 the plurality concluded that, “in light of the record, that the district court’s significant findings, both as to burdens and benefits, have ample evidentiary support.”29 therefore, the supreme court found louisiana act 360 to be unconstitutional.30 chief justice roberts wrote a concurrence that for many commentators and legal scholars confused the issue of whether the decision should be called a plurality or a majority opinion.31 roberts agreed that whole woman’s health was controlling precedent,32 and, therefore, louisiana’s act 620 must be unconstitutional, but disagreed that any part of casey required the balancing of benefits and burdens of a statute seeking to restrict abortions. the high court interpreted roberts’ concurrence as rejecting the premise that casey and whole women’s health applied the same standard in deciding whether a law restricting access to abortion was constitutional.33 however, roberts’ concurrence did state: stare decisis instructs us to treat like cases alike. the result in this case is controlled by our decision four years ago invalidating a nearly identical texas law. the louisiana law burdens women seeking previability abortions to the same extent as the texas law, according to factual findings that are not clearly erroneous. for that reason, i concur with the judgment of the court that the louisiana law is unconstitutional.34 this statement in roberts’ concurrence served as the basis of the plurality’s claim to a 5-4 decision in the june medical case. justices alito, gorsuch, kavanaugh, and thomas filed dissenting opinions, with several justices signing on in agreement with dissenting colleagues. in his lengthy dissent, justice alito argued that whole woman’s health was a post27. june med. 1, 140 s. ct. at 2118. 28. id. at 2120. 29. id. at 2131. 30. id. 31. see, e.g., rachel rebouche, abortion restrictions after june medical services, regul. rev. (aug. 4, 2020), https://www.theregreview.org/2020/08/04/rebouche-abortion-restrictionsjune-medical/ [https://perma.cc/hs8n-yxdn]. see also benjamin m. parks, burdens, benefits, or both? the impact of chief justice roberts’s june medical concurrence on courts’ analyses of abortion regulations, la. l. rev., https://lawreview.law.lsu.edu/2021/03/12/burdens-benefits-orboth-the-impact-of-chief-justice-robertss-june-medical-concurrence-on-courts-analyses-of-abortionregulations/ [https://perma.cc/r76h-6p9s] (last visited mar. 12, 2021). 32. june med. 1, 140 s. ct. at 2142. 33. id. at 2180-81. 34. id. at 2142. 334 indiana health law review [vol. 19:329 enforcement decision, whereas june medical is a pre-enforcement decision.35 he repeated the charge of lack of standing for planned parenthood, accused the district court of portraying faulty facts, and contended that the plaintiff doctors in the suit sought to secure admitting privilege in bad faith.36 alito concluded by stating that the plurality “twists the law.”37 justice gorsuch, on the other hand, pointed to a “catalog of horribles,” examples of numerous instances of safety and ethical violations in the planned parenthood abortion facilities.38 he dubbed the balancing of benefits and burdens analysis “little more than the judicial version of a hunter’s stew.”39 gorsuch accused the court of taking a static view of the current market,40 and concluded that additional fact-finding was necessary to evaluate the louisiana law.41 justice kavanaugh’s relatively short dissent agreed with gorsuch’s analysis and emphasized the possibility that the plaintiff doctors might still obtain admitting privileges and clinics may not have to close.42 justice thomas began his dissent with a succinct summary of his position, stating, “a majority of the court perpetuates its ill-founded abortion jurisprudence by enjoining a perfectly legitimate state law and doing so without jurisdiction.”43 he challenged the plurality’s decision to waive the state’s argument that the plaintiff doctors did not have article iii standing, and argued that, indeed, all of the abortion precedents were created “without a shred of support from the constitution’s text.”44 despite the dissents’ panoply of contradictions to the plurality’s decision, chief justice roberts’ concurrence allowed the high court to claim a majority decision in june medical. c. parental notification requirement for minors seeking abortion on july 2, 2020, the supreme court also remanded a second ppink lawsuit in order to examine the court’s decision in june medical services.45 that lawsuit challenged indiana’s amended requirement for parental notification of minors seeking an abortion.46 35. id. at 2158. 36. id. at 2160. 37. id. at 2170. 38. id. at 2173. 39. id. at 2179-80. 40. id. at 2177. 41. id. at 2182. 42. id. 43. id. at 2142. 44. id. 45. see box, comm’r, ind. state dep’t of health v. planned parenthood of ind. & ky., inc. (planned parenthood of ind. & ky., inc. 3), 141 s. ct. 187 (2020). kristina m. box was commissioner of the indiana state department of health from october 16, 2017 to the present day. 46. see planned parenthood of ind. & ky., inc. v. adams, comm’r, ind. state dep’t of 2022] checking the box-es 335 the majority in the seventh circuit began by explaining that indiana statutes had long provided a speedy and confidential bypass procedure to allow that small fraction of pregnant, unemancipated minors seeking an abortion to obtain such without the consent or notification of parents, guardians, or custodians.47 however, in 2017 the indiana general assembly passed senate enrolled act 404 (“sea 404”)48 which added a parental notification requirement to the judicial bypass.49 ppink sued to enjoin enforcement of the new provision, and the district court granted a preliminary injunction.50 appeal to the seventh circuit followed, challenging the provision of the new law that required that, even if a judge concludes that the parents need not consent to the abortion because either (1) the unemancipated minor is mature enough to make her own decision about abortion, or (2) the abortion is in the minor’s best interest, parents must still be given prior notice of the planned abortion unless the judge finds the notification is not in the minor’s best interest.51 therefore, under the amended law, the judicial bypass of consent may be based on either the minor’s maturity or best interests, but the judicial bypass of notification must be based solely on “best interests.” however, the parental notification is triggered only if the judge authorizes the abortion.52 in addition to the significant change in language about judicial bypass of notification, the seventh circuit further noted the delay in obtaining the abortion because of the statute’s provision that the minor’s attorney shall serve the notice to the parents by certified mail or personal service prior to the abortion.53 the new law also required that the physician who would perform the abortion must not only obtain written parental consent, but require government-issued evidence of the parent’s, legal guardian’s, or custodian’s identity, and execute an affidavit of that reliable evidence of identity. criminal penalties were also provided in the new statute, for both physicians and planned parenthood health centers.54 the seventh circuit majority noted that the district court had enjoined the new law because the notice requirement was likely to cause an “undue burden for the large fraction of mature, abortion-seeking minors in indiana.”55 the state health (planned parenthood of ind. & ky., inc. 4), 937 f.3d 973 (7th cir. 2019), reh’g and reh’g en banc denied oct. 30, 2019. jerome m. adams was commissioner of the indiana state department of health from october 14, 2014 to september 1, 2017, the time period during which this appellate decision originated in the southern district of indiana. 47. id. at 974. 48. s.e.a. 404, 120th gen. assemb., first reg. sess. (2017). 49. planned parenthood of ind. & ky., inc. 4, 937 f.3d. at 975. 50. see planned parenthood of ind. & ky., inc. v. comm’r, ind. state dep’t of health (planned parenthood of ind. & ky., inc. 5), 258 f. supp. 3d 929 (s.d. ind. 2017). 51. planned parenthood of ind. & ky., inc. 4, 937 f.3d at 975-76. 52. id. 53. id. at 976-77. 54. id. 55. id. at 978. 336 indiana health law review [vol. 19:329 argued unsuccessfully that a pre-enforcement facial challenge to the new law was contrary to seventh circuit precedent, but the appellate court instead relied on the high court’s decision in whole women’s health, also a pre-enforcement challenge, which confirmed the casey undue burden standard.56 in explaining the undue burden imposed by sea 404, the majority noted that between october 2011 and september 2017, approximately sixty minors, mostly seventeen-year-olds, sought judicial bypasses.57 the young women had not told their parents they were pregnant because they feared being “kicked out of their homes . . . being abused or punished,” or that their parents would try to block an abortion.58 examining the standards for a preliminary injunction, the seventh circuit concluded that ppink demonstrated a likelihood of success on the merits because (1) the new indiana statute “creates a substantial risk of a practical veto over a mature minor’s right to an abortion, and “[u]nder casey, a statute that will have the practical effect of giving someone else a veto over a woman’s abortion decision is an undue burden,”59 (2) factual evidence showed that most judicial bypasses for minors’ abortions were granted on the basis of the minor’s maturity,60 (3) balancing the benefits and the burdens of the new statute demonstrates that the burdens for minors seeking abortions outweigh the state’s interest in helping parents care for their daughters,61 and (4) a notice requirement can operate as a consent requirement because of a minor’s fear of abuse, parental obstruction, triggering dangerous self-help abortions, or foregoing abortion altogether.62 the seventh circuit concluded that the district court did not abuse its discretion in issuing the preliminary injunction, and affirmed the district court decision.63 circuit judge kanne issued a lengthy dissent, arguing that precedent in other circuit courts, including the casey decision, confirmed that both parental consent and notification laws were constitutional.64 kanne noted that the state “possesses ‘important’ and ‘reasonable’ interests in requiring parental consultation before a minor makes such an irrevocable and profoundly consequential decision.”65 the state of indiana appealed from the district court decision, requesting a rehearing and a rehearing en banc.66 both were denied by a divided en banc court, and indiana petitioned for certiorari to the supreme court. in a per curiam 56. id. at 979-80. 57. id. at 977. 58. id. 59. id. at 981. 60. id. at 982. 61. id. at 983-84. 62. id. at 986-87. 63. id. at 990-91. 64. id. at 991. 65. id. at 992 (quoting bellotti v. baird, 443 u.s. 622, 640-41 (1979)). 66. see planned parenthood of ind. & ky., inc. v. box, comm’r, ind. state dep’t health (planned parenthood of ind. & ky., inc. 6), 949 f.3d 997 (7th cir. 2019). 2022] checking the box-es 337 opinion, the high court granted the petition for certiorari and on july 2, 2020 vacated the judgment below and remanded the case to the seventh circuit for reconsideration in light of june medical.67 on march 12, 2021, the seventh circuit responded at length to the high court’s remand.68 applying the doctrine of the “narrowest ground” rule69 to interpret the fractured decision in june medical, the seventh circuit reaffirmed its earlier preliminary injunction. the appellate court noted that chief justice roberts, in his concurrence, agreed that whole woman’s health was applicable as stare decisis in june medical, even as he disagreed with portions of the plurality opinion, stating “[t]he opinions in june medical show that constitutional standards for state regulations affecting a woman’s right to choose to terminate a pregnancy are not stable, but they have not been changed, at least not yet, in any way that would change the outcome here.”70 the court noted that the louisiana law in june medical “tracked nearly word-for-word” the texas law struck down in whole woman’s health.71 in his concurrence, roberts’ emphasis on downplaying the value of balancing benefits and burdens prompted the high court to question whether a true majority opinion could be cobbled together in june medical. the high court questioned whether roberts’ concurrence fit more squarely with the opinions of the other dissenters, justices alito, gorsuch, and thomas. however, under the marks rationale, dissents are excepted from consideration in plurality opinions. that rationale settled the decision for the seventh circuit.72 the state of indiana filed a second petition for certiorari on march 29, 2021, and a decision on that petition is pending. on june 8, 2021, the court scheduled a june 24 conference to consider a grant of certiorari. the high court had yet to announce a decision at the end of the 2020 term.73 67. see box, comm’r, ind. state dep’t of health v. planned parenthood of ind. & ky., inc. (planned parenthood of ind. & ky., inc. 7), 141 s. ct. 187 (2020) (mem.). 68. planned parenthood of ind. & ky., inc. v. box, comm’r, ind. state dep’t of health (planned parenthood of ind. & ky., inc. 8), 991 f.3d 740 (7th cir. 2021). 69. the “narrowest ground” rule from marks v. united states, states that when assessing which precedential decisions apply in plurality decisions, the court must look for the common ground expressed by the plurality and the concurrence(s). 430 u.s. 188, 193 (1977). king v. palmer states that the narrowest ground rule means that “when, for example, ‘the concurrence posits a narrow test to which the plurality must necessarily agree as a logical consequence of its own broader position,” the plurality can claim to be a majority opinion which then has precedential value. planned parenthood of ind. & ky., inc. 8, 991 f.3d at 745-46 (quoting 950 f.2d 771, 782 (d.c. cir. 1991) (en banc)). 70. planned parenthood of ind. & ky., inc. 8, 991 f.3d at 741. 71. id. at 742. 72. id. at 745. 73. box. v. planned parenthood of indiana and kentucky, scotusblog, https://www. scotusblog.com/case-files/cases/box-v-planned-parenthood-of-indiana-and-kentucky-inc-4/ [https://perma.cc/2wf4-e2mf] (last visited jan. 15, 2022). 338 indiana health law review [vol. 19:329 iii. indiana’s attempt to revise disposal of fetal remains and ban selective abortions indiana’s general assembly attempted to delay a pregnant woman’s attempt to proceed with an abortion by mandating an eighteen-hour waiting period. they also tried to place a parental notification requirement to restrict a minor’s access to abortion. next, they attempted to revise the process for the disposal of fetal remains. finally, they tried to ban all voluntary selective abortions based on discernible fetal characteristics. the supreme court ultimately weighed in on the litigation. however, it was only in a partial and unsatisfactory way for justice sotomayor.74 the governor of indiana signed house enrolled act 1337 (“hea 1337”) into law on march 24, 2016.75 the act included three challenged provisions, the first being the “sex selective and disability abortion ban,” prohibiting a person from performing a pre-fetal viability abortion if the person knows the woman is seeking an abortion solely for reasons of: (1) the sex of the fetus, (2) fetal diagnosis of down’s syndrome or “any other disability,” genetically inherited, either physical or mental, or (3) because of the race, color, national origin, or ancestry of the fetus.76 violating this provision of law would be a felony under indiana’s existing statutes, and the abortionist would be subject to disciplinary sanctions and civil liability for wrongful death.77 the second provision would have required the abortion provider to advise the woman of the new prohibition on discriminatory abortion.78 the third prohibition concerned the disposal of fetal remains after abortion. while preserving the right of a woman to dispose of the fetal remains herself, hea 1337 provided that fetal remains be disposed of in the same way as indiana law requires for a dead human body, interred or cremated after receipt of a “burial transmit permit.”79 aborted fetuses could no longer be incinerated with other surgical byproducts, infectious or pathological waste.80 a. the seventh circuit decisions shortly after the enactment of hea 1337, ppink filed an action in indiana district court seeking a preliminary injunction barring the state from enforcing the new provisions.81 the district court granted the preliminary injunction and, upon 74. see box, comm’r ind. dep’t pub. health v. planned parenthood of ind. & ky., inc. (planned parenthood of ind. & ky., inc. 9), 139 s. ct. 1780 (2019). 75. planned parenthood of ind. & ky., inc. v. comm’r ind. state dep’t health (planned parenthood of ind. & ky., inc. 10), 888 f.3d 300, 302 (7th cir. 2018). 76. id. at 302-03. 77. id. at 303. 78. id. 79. id. at 304. indiana law requires a “burial transmit permit” for transport and disposition of a dead human body. 80. id. 81. id. 2022] checking the box-es 339 ppink’s subsequent motion for summary judgment, granted a permanent injunction.82 the seventh circuit referenced the continuing viability of the roe decision and casey’s reaffirmation of roe’s “essential holding” that a woman may “choose to have an abortion before viability and to obtain it without undue interference from the state.”83 the court characterized the woman’s right as “categorical,” reiterating that “a state may not prohibit any woman from making the ultimate decision to terminate her pregnancy before viability” [emphasis in the original].84 acknowledging that both roe and casey provided that not all regulations are unwarranted, because the state has a substantial interest in potential life, the court nevertheless ruled that the ban on discriminatory abortions violated “well-established supreme court precedent[s]” and was, therefore, unconstitutional.85 the seventh circuit, on the other hand, noted, “[s]imply put, the law does not recognize an aborted fetus as a person.”86 in addition, the court recognized that, under the new fetal disposal provisions, (1) the woman retained the right to dispose of the aborted fetus, and (2) aborted fetuses could be cremated together without prior authorization, which is not the same treatment reserved for human remains.87 therefore, under rational basis review, the court found no rational basis for the state’s interest in disposing of “human remains” humanely and with dignity.88 the court declared the fetal remains provision of hea 1337 to be unconstitutional.89 circuit judge manion concurred in the decision about the unconstitutionality of the ban on selective abortions but disagreed with the court’s decision about the disposal of fetal remains. his partial concurrence, however, was critical of the court’s reliance on roe as some kind of “super-precedent.”90 manion went on to state, “[t]hat today’s outcome is compelled begs for the supreme court to reconsider roe and casey.”91 manion also argued for recognizing the dignity of an aborted fetus. stating that if “[s]tates may value the dignity of an unborn child,” states may still recognize the inherent dignity and humanity of the aborted child.92 he proposed 82. planned parenthood of ind. & ky., inc. v. comm’r ind. state dep’t of health (planned parenthood of ind. & ky., inc. 11), 265 f. supp. 3d 859, 861 (s.d. ind. 2017). 83. planned parenthood of ind. & ky., inc. 10, 888 f.3d at 305. 84. id. (citing planned parenthood of southeastern pa. v. casey, 505 u.s. 833, 879 (1992)). 85. id. at 306. this reliance on precedent to establish unconstitutionality, challenged in the dissent, may be significant for future developments. 86. id. at 308. 87. id. at 309. 88. id. at 309-10. 89. id. at 310. 90. id. at 311-12 (quoting senate judiciary committee member dianne feinstein’s characterization of roe v. wade). 91. id. at 313. 92. id. at 319. 340 indiana health law review [vol. 19:329 that the fetal remains provision was within the police power of indiana.93 ppink motioned for, and was initially granted, rehearing en banc on the district court decision on the fetal remains provision, and the decision of the seventh circuit was vacated.94 however, one of the judges who voted for the rehearing subsequently recused himself, and the rehearing en banc was reversed, and the prior order vacated.95 chief judge wood, joined by judges rovner and hamilton, concurred, in order to explain, first, why the request for a rehearing concentrated only on the fetal remains issue. wood explained that, because of the seventh circuit’s dependence on the precedent of casey in its decision, ppink recognized that a rehearing on the issue of the selective abortion ban would have been futile: only the supreme court would have had the power to overturn casey.96 wood explained, however, that rehearing en banc on the fetal remains decision would have been “distorted” by the seventh circuit’s incorrect reliance on the rational basis standard of review of the fetal remains part of the statute. wood explained that the seventh circuit had not presented any evidence that the fetal remains provision could or could not present an undue burden to the woman who desired to abort, either preor post-abortion, either raising the cost of fetal disposal or creating psychological trauma that would make a woman forego an abortion.97 wood, therefore, stated that it would have been useless for the court to rehear the decision on the fetal remains provision if all the en banc court were able to say was that the incorrect standard of review was binding on them, but that things could have been different if the standard from casey and whole woman’s health had been applied.98 judge easterbrook, joined by sykes, barrett, and brennan, dissented from the denial of rehearing en banc.99 although ppink did not request rehearing for the selective abortion provision of the indiana statute, easterbrook peremptorily characterized that provision of the law as the “eugenics statute.”100 he stated that casey did not consider an anti-eugenics law. although irrelevant to the question presented, easterbrook continued, stating that “[u]sing abortion to promote eugenic goals is morally and prudentially debatable on grounds different from those that underlay the statutes.”101 easterbrook finally turned to the provision of the statute at hand, stating that because “x” is not a person, does not mean that “x” is beyond regulatory 93. id. at 321. 94. see planned parenthood of ind. & ky., inc. v. comm’r ind. state dep’t health (planned parenthood of ind. & ky., inc. 12), 727 fed. appx. 208 (7th cir. 2018) (mem.). 95. see planned parenthood of ind. & ky., inc. v. comm’r ind. state dep’t health (planned parenthood of ind. & ky., inc. 13), 917 f.3d 532 (7th cir. 2018). 96. id. at 535. 97. id. at 535-36. 98. id. at 536. 99. id. 100. id. 101. id. 2022] checking the box-es 341 authority, and gave examples of animal welfare statutory authority, specifically mentioning laws for humane treatment of dogs, cats, and gerbils.102 he supported the seventh circuit panel’s application of rational basis review to support their decision on the disposal of fetal remains. in the end, he accused the majority of the en banc court of “[k]icking the can down the road” when “we have reached the road’s end.”103 kristina box, then commissioner of the indiana department of health, filed a petition for certiorari to the supreme court on october12, 2018. the petition was originally scheduled for conference on december 19, 2018, but was rescheduled fourteen times until the petition was granted on may 28, 2019, but only for the provision of the indiana law on disposal of fetal remains.104 b. the supreme court decision the supreme court bifurcated the petition for certiorari and ruled only on the second question in the petition: whether the seventh circuit decision on disposal of fetal remains was invalid, even under the deferential standard of rational basis review.105 the high court reviewed the seventh circuit’s rationale in deciding to declare the fetal remains provision in hea 1337 unconstitutional. however, the court noted that prior decisions of the court had acknowledged that the state has a legitimate interest in regulating disposal of aborted fetuses,106 and therefore upheld the disposal of fetal remains provision in the indiana law. the court also noted that the seventh circuit never held that the disposal regulations posed an undue burden on a woman seeking an abortion.107 the brief opinion of the court noted that the court expressed no opinion on the merits of the selective abortion question because the seventh circuit was the first circuit court to address this issue. the “ordinary practice” of the high court, the majority noted, was to defer judgment until additional courts of appeal consider the same question.108 justice sotomayor expressed her opinion that she would have denied the petition for certiorari as to both questions in the initial petition but provided no 102. id. at 537-38. 103. id. at 538. these kinds of comments by judge easterbrook are of the kind that caused pamela karlan to call easterbrook a “loose cannon” in her oral arguments in the bostock case. see transcript of oral arguments, bostock v. clayton county, georgia, 140 s. ct. 1731 (2020) (no. 17-1618, no. 17-1623). 104. box v. planned parenthood of indiana and kentucky inc., scotusblog, https://www. scotusblog.com/case-files/cases/box-v-planned-parenthood-of-indiana-and-kentucky-inc/ [https://perma.cc/8t2h-wayb] (last visited jan. 13, 2022). 105. planned parenthood of ind. & ky., inc. 9, 139 s. ct. 1780, 1780 (2019). 106. id. at 1782, (citing akron v. akron ctr. reproductive health, 462 u.s. 416, 452 n. 45 (1983)). 107. id. 108. id. 342 indiana health law review [vol. 19:329 explanation.109 justice ginsburg concurred in part but dissented in part.110 ginsburg disagreed with the basis for the court’s reversal, the rational basis standard of review of the fetal disposal provision, stating that a correct standard of review may have restored the appellate court’s judgment. ginsburg would have applied a heightened standard of review involving an undue burden analysis. ginsburg reiterated the opinion of chief judge woods in denying the rehearing en banc, agreeing with wood that simply taking a case to say the court is bound by a former standard of review, but that “everything might be different” under a new standard would be futile.111 in typical scalia fashion, ginsburg stated she would have denied indiana’s petition in its entirety.112 only justice thomas, perhaps prompted by easterbrook’s comments in the petition for rehearing en banc, in his concurrence dealt at length with the part of the indiana law that the majority ignored: the selective abortion issue.113 thomas’s concurrence has prompted such a great deal of commentary that his observations and comments are treated separately below. the decision of the supreme court after grant of certiorari did not end the case for ppink. ppink, as prevailing party even if only in the most partial sense, returned to indiana district court to request attorneys’ fees and costs.114 after some discussion of reducing the grant of fees by 50% for the partial nature of ppink’s successful ruling, the court awarded “reasonable” attorneys’ fees and costs as requested, $182,499.73. iv. relevance of selective abortions to the eugenics movement a. justice thomas’s concurrence beginning his concurrence, justice thomas lauded indiana’s ban on selective abortion as promoting the state’s compelling interest in “preventing abortion from becoming a tool of modern-day eugenics.”115 thomas’s narrative continued with what he presented as the origin story of the fight for legal abortion, the birth-control movement of the early twentieth century.116 in particular, he focused on the work of planned parenthood founder margaret sanger, whom, he asserted, recognized the eugenic potential of her cause and argued that, “‘birth control . . . is really the greatest and most truly eugenic method’ of ‘human generation.’”117 thomas conceded that sanger was not referring to abortion in her comments, “at least not directly,” but stated that “sanger’s arguments about the eugenic 109. id. 110. id. at 1793. 111. id. 112. id. 113. id. at 1783. 114. id. at 1780. 115. id. 116. id. 117. id. at 1783-84. 2022] checking the box-es 343 value of birth control . . . apply with even greater force to abortion.”118 thomas, therefore, reasoned that the motives of those who still support legal abortions may lay in eugenics.119 thomas’s conclusion, expressed early in his concurrence was that “given the potential for abortion to become a tool of eugenic manipulation, the court will soon need to confront the constitutionality of laws like indiana’s.”120 he catalogued the rise of the eugenics movement in america. by the 1920s, according to thomas, eugenics became an “intellectual craze,” and found support among progressive, professionals, and the intellectual elite, especially at prominent universities, notably harvard.121 eugenics, thomas continued, rapidly coalesced with those who supported the theory of white intellectual superiority to that of the negro race. that coalescence, he contended, helped to precipitate the immigration act of 1924, which reduced immigration from outside western and northern europe, and led to race consciousness in marriage and reproductive decisions, including antimiscegenation laws.122 thomas also noted how the court supported forced sterilization of misfits and the “feeble-minded,” as in the buck v. bell decision, where oliver wendell holmes notoriously asserted that “[t]hree generations of imbeciles are enough.”123 however, thomas noted, the rise of naziism in the 1940s somewhat lessened america’s craze with the eugenics movement, but thomas, nevertheless, pressed his argument that abortion is an “act rife with the potential for eugenic manipulation.”124 in fact, later in his concurrence, thomas posited that with the rise and reliability of prenatal screening tests and other technologies, “the individualized nature of abortion gives it more eugenic potential than birth control.”125 abortions for fetuses identified with down syndrome occur at very high rates, as do abortions of female children, and the abortion rate among black women is 3.5 times that of white women.126 thomas says easterbrook was correct in his urging for en banc review in opposition to the seventh circuit’s denial: “casey did not decide whether the constitution requires states to allow eugenic abortions.”127 thomas’s conclusion was that the court’s denial of certiorari to the part of the indiana law banning selective abortions leaves the issue an open question, but that the denial should 118. id. at 1784. 119. id. this logic, however, failed to recognize the complex context in which sanger existed within the eugenics movement. 120. id. 121. id. at 1785-86. 122. id. 123. id. at 1786 (citing 274 u.s. 200, 208 (1927)). 124. id. at 1786-87. 125. id. at 1790. 126. id. at 1790-91. 127. id. at 1792. 344 indiana health law review [vol. 19:329 not be interpreted as agreement with the decisions below.128 thomas concluded his concurrence with this assessment: although the court declines to wade into these issues today, we cannot avoid them forever. having created the constitutional right to an abortion, this court is dutybound to address its scope. in that regard, it is easy to understand why the district court and the seventh circuit looked to casey to resolve a question it did not address. where else could they turn? the constitution itself is silent on abortion. with these observations, i join the opinion of the court.129 b. critiquing thomas’s concurrence thomas’s concurrence was met with severe and widespread criticism for what commentators charged was a distortion of history.130 disability rights advocates also linked thomas’s concurrence with justice kavanaugh’s former comments on supporting abortions for people with intellectual disabilities.131 as previously noted, in the early 1920s, eugenic sterilization laws received great support. in contrast, sanger’s birth-control movement struggled for support. therefore, championing eugenics “made sense for a movement lacking popularity, powerful political allies, or elite intellectual credentials.”132 as seen through the support of eugenics by such powerful leaders as teddy roosevelt — he called on anglo-saxon women to stop “race suicide” by having more children — eugenics was a cause with widespread support at the time.133 as such, sanger’s view merely reflected the time and to identify her support as anything more than strategic was an oversimplification on thomas’s part. thomas also attempted to connect the eugenics movement to the population control movement of the 1950s to 1970s, and thus, connect both back to the modern abortion rights movement. according to mary ziegler, thomas argued that eugenics “. . . lost popularity because of opposition to the nazi movement (which openly endorsed compulsory sterilization) and because of the obvious problems with the science underlying eugenicists work. population-control 128. id. 129. id. at 1793. 130. eli rosenberg, clarence thomas tried to link abortion to eugenics. seven historians told the post he’s wrong, wash. post (may 30, 2019), https://www.washingtonpost.com/history/ 2019/05/31/clarence-thomas-tried-link-abortion-eugenics-seven-historians-told-post-hes-wrong/ [https://perma.cc/455b-7mqr]. 131. see samuel r. bagenstos, disability and reproductive justice, 14 harv. l. & pol’y rev. 273 (2020). bagenstos reported that during kavanaugh’s nomination for the supreme court, disability advocates drew attention to then-judge kavanaugh’s support for government decisions requiring intellectually disabled individuals to have abortions. id. at 275. 132. mary ziegler, bad effects: the misuses of history in box v. planned parenthood, 105 cornell l. rev. 165, 198 (2020). 133. id. at 198. 2022] checking the box-es 345 arguments in his telling, simply replaced eugenic rhetoric that had become taboo.”134 like the origin of the eugenics movement, though, the motivations for the population control movement were far more nuanced. while some who joined the movement harbored eugenic intentions, such as dixie cup company founder hugh moore,135 others joined for a variety of reasons. for example, representative george h.w. bush of texas viewed the movement as an extension of cold war politics and concluded that population control would stop the growth of communism.136 indeed, on college campuses, groups of zero population growth inc. formed which framed population control as a method for environmental advocacy or advancing women’s liberation.137 equating eugenics in the united states with such topics is an oversimplification. in roe the high court’s narrative asserted women-protective health reasons to show that previous nineteenth-century abortion bans were no longer substantial.138 the roe court affirmed that physicians had previously led campaigns to criminalize abortion out of fear of the safety of the procedure.139 because of this, throughout the 1970s, medical organizations weakened or abandoned their abortion opposition. this included the american medical association and american public health association.140 however, ziegler noted, thomas argued that “motives darker than we believed” underlaid the court’s decision on abortion.141 v. whether indiana’s abortion restrictions challenge roe and its progeny prenatal genetic screening makes it possible to diagnose many diseases in the earliest stages of pregnancy.142 thousands of human diseases have genetic components which may be detected. depending on the condition, this may range from a defect in a single gene to many genes. receiving results that an unborn child has a condition can be a deeply personal and heartbreaking experience for a mother. thomas’s argument oversimplified the idea of genetic testing to say that “with today’s prenatal screening tests and other technologies, abortion can easily be used to eliminate children with unwanted characteristics.”143 134. id. 135. id. 136. id. at 199. 137. id. 138. roe v. wade, 410 u.s. 113, 150 (1973). 139. id. at 146-49. 140. ziegler, supra note 132, at 169. 141. id. at 201. 142. prenatal genetic screening tests: frequently asked questions, am. c. obstetricians & gynecologists, https://www.acog.org/womens-health/faqs/prenatal-genetic-screening-tests [https://perma.cc/74vn-nhvn] (last updated oct. 2020). 143. planned parenthood of ind. & ky., inc. 9, 139 s. ct. 1780, 1790 (2019). 346 indiana health law review [vol. 19:329 abortion is intimately and inescapably tied to the concept of a woman’s bodily privacy. even the roe decision itself mentioned the strict constructionist problem inherent in the concept of privacy, stating “[t]he constitution does not explicitly mention any right of privacy. in a line of decisions, however, the court has recognized that a right of personal privacy, or a guarantee of certain areas or zones of privacy, does exist under the constitution.”144 in eisenstadt v. baird, the court decided that the right to privacy extended to procreative decision making by the married and unmarried.145 in this case, william baird gave a female student a contraceptive following a lecture on birth control.146 massachusetts charged baird with a felony under a law which was designed to prevent premarital sex.147 the law banned distribution of contraceptives to unmarried men and women; only married couples could obtain contraceptives and only from doctors or pharmacists.148 the court decided that the fourteenth amendment right to equal protection applied to both married and unmarried individuals’ ability to access contraceptives.149 as such, individuals have the constitutional right to privacy in decisions regarding their procreative choice and contraception.150 the roe majority asserted the right to privacy “under the due process clause of the fourteenth amendment’s concept of liberty,” stating that such clause “is broad enough to encompass a woman’s decision whether or not to terminate her pregnancy.”151 the seventh circuit added that “[n]othing in the fourteenth amendment or supreme court precedent allows the state to invade this privacy realm to examine the underlying basis for a woman’s decision to terminate her pregnancy prior to viability.”152 eugenics strives to better the entire human race.153 as john harding wrote a generation ago, “[t]he promise of genetic science, particularly human genetic engineering, appeals to that in humans which strives for perfection – perfection in oneself, one’s life, one’s children154. . .[w]ith each new discovery of genetic links to disease, however, the likelihood increases that more eugenic programs will be implemented.”155 eugenics is a population concept. thomas’s concurrence discussing indiana’s selective abortion statute overlooks the fact that every state which permits race, 144. roe, 410 u.s. at 152 (citations omitted). 145. see eisenstadt v. baird, 405 u.s. 438 (1972). 146. id. 147. id. 148. id. 149. id. 150. id. 151. roe v. wade, 410 u.s. 113, 153 (1973). 152. planned parenthood of ind. & ky., inc. 10, 888 f.3d 300, 307 (7th cir. 2018). 153. see john r. harding, jr., beyond abortion: human genetics and the new eugenics, 18 pepp. l. rev. 471 (1991). 154. id. at 471. 155. id. at 485. 2022] checking the box-es 347 or disability selective abortion, also leaves prospective parent(s) with the ability to select offspring traits of their choice.156 individuals are free to discard embryos that test positive for disease or even to set aside sperm and egg donations of different ethnicity. if the selective abortion provision of the disputed indiana law sought to “control the population and improve its quality,”157 as thomas implies, then genetic screening should not allow non-eugenic-related choices. indeed, the ultimate ability of choice distinguishes genetic testing from any connection to eugenic acts. the supreme court declined to grant certiorari to the major question in planned parenthood v. commissioner of the indiana state department of health, the selective abortion based on race, sex, and disability provision in hea 1337.158 the court explained that at the time of their consideration of the provision, no other circuit courts had considered the issue.159 while the seventh circuit permanently enjoined the ban on selective abortion, the fact that the court did not decide on the constitutionality of the ban leaves opportunity for such a ban to reappear in other jurisdictions. and, indeed, it already has. according to the charlotte lozier institute, at least fifteen states have enacted bans on performance of abortions based on the sex, race, and/or the presence of a genetic abnormality of the unborn child.160 the lozier institute reported that since the supreme court declined to rule on the indiana selective abortion ban, the sixth circuit has affirmed a lower court’s injunction of an ohio ban on abortions of fetuses screened positive for down syndrome. further, an injunction against an ohio law banning abortions based on sex, race, or down syndrome is on appeal.161 selective abortion bans have also been contested in the eighth circuit for bans enacted by arkansas and missouri.162 indiana case law points out the persistence of the factions that would diminish women’s rights to abortion and completely overturn roe. and indiana’s efforts are not exhausted. the grant of certiorari for considering indiana’s law requiring the parental notification for minors seeking an abortion – the second petition, after remand – is still pending. the court scheduled a conference for june 24, 2021 but announced no action after that date. similarly, in the “no action” category, the failure of the court to consider and rule on the selective abortion provision of hea 1337 gives little information on 156. see planned parenthood of ind. & ky., inc. 9, 139 s. ct. 1780, 1783 (2019) (thomas, j., concurring). 157. id. at 1787. 158. see planned parenthood of ind. & ky., inc. 10, 888 f.3d. 300 (7th cir. 2018). 159. id. 160. mary e. harned, abortion cases in the higher federal courts, charlotte lozier inst. 1, 4 (july 2019), https://s27589.pcdn.co/wp-content/uploads/2019/07/abortion-cases-in-thehigher-federal-courts-on-point-33_2.pdf [https://perma.cc/9j3t-mys3]. 161. id. at 5-6. 162. id. at 4-5. 348 indiana health law review [vol. 19:329 the leaning of the court.163 however, whether the ban on selective and discriminatory abortions is, or is not, fatal for roe and casey is untested. in his commentary, michael stokes paulsen uses the example of workplace laws for hiring and firing.164 hiring and firing are both legal, but not for all reasons.165 in a similar way, paulsen argues, a ban on selective abortions is not a ban (or even an “undue burden” as in casey) on all abortions, but only on abortions for specific reasons.166 therefore, roe and casey can survive the ban. another “save” for roe and casey, according to paulsen, is to ban selective abortions for their social utility.167 selective abortions of females are hard to countenance when the purpose of making abortions legal is to further female gender equality.168 the state has a compelling interest in eliminating sex bias in society by preventing the abortion of a fetus simply because the fetus is female; and likewise has a similar compelling interest in promoting racial equality.169 these arguments, according to paulsen, allow a ban on selective abortions to coexist with the precedents of roe and casey.170 however, an even greater challenge to the continued viability of the roe and casey decisions is the fifth circuit’s jackson women’s health organization v. dobbs, decided by the fifth circuit,171 for which the supreme high court granted the petition for certiorari on may 17, 2021. the question presented in the fifth circuit was, “is mississippi’s law banning nearly all abortions after 15 weeks’ gestational age unconstitutional?”172 the question for certiorari was translated to, “whether all pre-viability prohibitions on elective abortions are unconstitutional?”173 contrary to the indiana statutory implications, this phrasing of the question for the court is a frontal assault on roe and its progeny. while the frontal attack in dobbs may be gaining the most attention, another controversy is even more insidious, and demonstrates the inaction of the supreme court most vividly.174 on may 26, 2021, texas adopted s.b. 8, and governor 163. see planned parenthood of ind. & ky., inc. 10, 888 f.3d. at 300. 164. michael stokes paulsen, abortion as an instrument of eugenics, 134 harv. l. rev. 415, 428 (2021). 165. id. 166. id. at 428-29. 167. id. 168. id. 169. id. at 429-30. 170. id. 171. see jackson women’s health org. v. dobbs, 945 f.3d 265 (5th cir. 2019). 172. id. 173. dobbs v. jackson women’s health organization, scotusblog, https://www. scotusblog.com/case-files/cases /dobbs -v-jackson -w om en s-h ea lth -organizat ion [https://perma.cc/dfk5-ek2f] (last visited jan. 16, 2022). the petition for certiorari was filed on june 15, 2020. the case was distributed for conference on september 2, 2020 but rescheduled for conference twenty-one times before grant of certiorari. id. 174. mary ziegler, supreme indifference: what the texas case signals about the court’s treatment of abortion, scotusblog (sept. 1, 2021, 3:28 pm), https://www.scotusblog.com/ 2022] checking the box-es 349 greg abbott signed the bill into law.175 the law bans all abortions, even those due to rape, incest, or the mother’s health, after a fetal heartbeat is detectable, usually at about the sixth week of pregnancy, a time at which many women might not even know they were pregnant. the new law criminalized abortion providers who violated the law but removed the responsibility of the state to enforce the law.176 private individuals were tasked with responsibility to sue the abortion providers, with the incentive of raking in at least $10,000 for each conviction.177 texas abortion providers sought to block the law from taking effect by an emergency application to the supreme court to act. the supreme court allowed the emergency application to expire, and on the day following the expiration, september 1, 2021, the court issued a brief order denying the application.178 the court, with one exception, reacted along party lines in a 5-4 decision, with chief justice roberts joining justices breyer, kagan, and sotomayor in dissent. roberts emphasized that the action of the court did not mean that s.b. 8 was constitutional, but that reassurance was surely little relief in the immediate present.179 what the high court will rule in the fifth circuit’s jackson women’s health organization v. dobbs case remains to be seen. however, issues of standing and other procedural concerns may be effective in s.b. 8 litigation, whatever the impact for or against the existing supreme court precedents. the nine individuals now sitting in the “high chairs” of the supreme court must make some difficult decisions, and, hopefully, those decisions will be made not along party lines, but according to the constitution and existing precedent. 2021/09/supreme-indifference-what-the-texas-case-signals-about-the-courts-treatment-of-abortion/ [https://perma.cc/5vhb-uwdy]. 175. letter from gregory s. davidson, exec. clerk gov., tex. gov. greg abbot, to hon. john b. scott, sec. state (nov. 8, 2021), https://gov.texas.gov/uploads/files/press/transmittal_ 2021-11-08_legislation_letter_image.pdf [https://perma.cc/q2tw-3khh]. 176. amy howe, supreme court leaves texas abortion ban in place, scotusblog (sept. 2, 2021, 2:26 am), https://www.scotusblog.com/2021/09/supreme-court-leaves-texas-abortion-banin-place/ [https://perma.cc/nf3g-24hh]. 177. id. 178. katie buehler, supreme court doesn’t stop texas “heartbeat” abortion bill, law 360 (sept. 1, 2021, 1:00 am), https://www.law360.com/articles/1417596/supreme-court-doesn-t-stoptexas-heartbeat-abortion-bill [https://perma.cc/6mwt-b9j2]. 179. id. inventions and patents for treating thyroid disease inventions and patents for treating thyroid disease brizzia munoz-robles and brian haney * 2023 abstract the thyroid is a bi-lobed gland located at the base of the neck that produces essential hormones for metabolic control in the human body. affecting nearly fifty-million americans, thyroid disease has become a ubiquitous cause for symptoms including depression, anxiety, psychosis, and heart disease. yet, while the healthcare law scholarship is visibly scaling, the research relating to law, innovation, and thyroid disease is completely naked. this article provides an interdisciplinary introduction to the thyroid patent dataset, an evolving mechanism for tracking progress in treatments for thyroid disease and advances the literature in providing the first consolidated review of patents for a specific disease. in short, this article explores the confluence of thyroid disease, patent law, and innovation policy to promote knowledge in human health relating to the human thyroid. ————————————————————————————— * thank you to our moms, mr. munoz, maria, christina, brad, nicolette 妹妹, broderick, jon j$, vince, zak, sawyer, jamie, athena, riggs, spearman, dr. blynn, prairie, dr. josh etzel, nick, seth, nate, g, mikey, mr. carr, mrs. carr, and xi liao. indiana health law review [vol. 21:277 278 table of contents introduction i. thyroid disease a. hypothyroidism b. hyperthyroidism c. diagnostics ii. inventions and patents a. treatments b. data c. claims iii. clinical commercialization a. value b. fda trials c. innovation iv. conclusion v. appendices appendix a. hypothalamic-pituitary-thyroid axis model appendix b. hypothalamic-pituitary-thyroid axis description appendix c. levothyroxine tablet information appendix d. symptoms for thyroid disease introduction one in six people have thyroid disease in their lifetime. 1 most people who have thyroid disease do not know because symptoms are not specific, and it is difficult to isolate in diagnostics. 2 still, second only to diabetes, thyroid diseases are the most ubiquitous endocrine disorders worldwide. 3 although thyroid diseases may be life lasting and terminal, they are generally considered treatable. 4 the thyroid is a bi-lobed gland located at the base of the neck in front of the windpipe. 5 the thyroid’s functionality is essentially synthesizing thyroid ————————————————————————————— 1. hypothyroidism, american thyroid association, 4 (2013), https://www.thyroid. org/wp-content/uploads/patients/brochures/hypothyroidism_web_booklet.pdf. 2. gay j. canaris et al., the colorado thyroid disease prevalence study, 160 archives internal med. 526, 526 (2000) (noting that abnormal biochemical thyroid function reports substantiate substantial populations suffer from subclinical conditions). 3. c.c. heuck et al., world health organization, diagnosis and monitoring of diseases of the thyroid 8 (2000), https://apps.who.int/iris/handle/10665/66342 [https://perma. cc/5j46-dcgg]. 4. id. 5. pharm. compositions to tetrac & methods of use thereof, u.s. patent no. 6,740,680 (issued may 25, 2004). https://perma https://apps.who.int/iris/handle/10665/66342 https://www.thyroid 2024] inventions and patents for treating 279 thyroid disease hormone.6 in other words, the thyroid produces hormones, which are secreted into the blood and control the body’s metabolism. 7 interestingly, thyroid hormone receptors are located throughout the brain, highlighting their importance in the central nervous system’s development and function.8 this article proceeds in three parts. part i explores thyroid disease, including diagnostics, hypothyroidism, and hyperthyroidism. part ii empirically investigates inventions for treatments to thyroid disease through the lens of the patent system. part iii consolidates considerations for commercialization of inventions for treating thyroid disease. the purpose of this article is advancing the literature and human knowledge in thyroid disease, intellectual property, and invention commercialization. ii. thyroid disease thyroid hormone synthesis and release is a three-step process feedback loop. 9 first, the hypothalamus produces thyroid releasing hormone (trh), 10 stimulating the pituitary gland 11 to release thyroid stimulating hormone (tsh), thyrotropin, 12 which in turn activates the thyroid gland. second, the thyroid gland excretes two thyroid hormones: thyroxine (t4) and triiodothyronine (t3) to the bloodstream. 13 third, t4 converts to t3 through deiodination in peripheral ————————————————————————————— 6. see appendix b. hypothalamic-pituitary-thyroid axis model; see also heuck et al. supra note 3, at 8; see also elske t. massolt, translational studies toward understanding clinical effects of thyroid hormone 9 (nov. 21, 2017) (phd thesis, erasmus university rotterdam), https://repub.eur.nl/pub/102891/proefschriftmassoltvoorpedel.pdf [https://perma.cc/78xp-zk rc] (“thyroid hormone is synthesized by the thyroid gland, which is located ventrocaudal of the thyroid cartilage.”). 7. am. thyroid ass’n, hypothyroidism 4 (2019), https://www.thyroid.org/wpcontent/uploads/patients/brochures/hypothyroidism_web_booklet.pdf [https://perma.cc/8ws9erca]. 8. larry squire et al., fundamental neuroscience 910 (3rd ed. 2008); see also massolt, supra note 6, at 10 (“thyroid-stimulating hormone production is stimulated by hypothalamic thyrotropin releasing hormone.”). 9. massolt, supra note 6, at 9. 10. squire et al., supra note 8, at 909 (“trh neurons have long axons that terminate in the [median eminence’s] external zone. this region is highly vascularized by the portal capillary system, which transports trh to the anterior pituitary gland. there, trh targets receptors on thyrotropes, which are cells that, when stimulated, produce the thyroid-stimulating hormone. thyrotropes constitute approximately 10% of the cells in the anterior pituitary gland.”). 11. heuck et al., supra note 3, at 5 (thyroid stimulating hormone is a “hormone produced by the pituitary gland in response to signals from the hypothalamus.”). 12. id. (thyrotrope cells in the pituitary gland produce a glycoprotein hormone called thyrotropin, which regulates endocrine function). 13. id. at 8. https://perma.cc/8ws9 https://www.thyroid.org/wp https://perma.cc/78xp-zk https://repub.eur.nl/pub/102891/proefschriftmassoltvoorpedel.pdf indiana health law review [vol. 21:277 280 tissues. 14 this synthesis is critical for metabolic control in the human body. 15 thyroid disease control is extremely essential, and abnormalities can have catastrophic consequences. 16 thyroid hormone imbalance can have profound effects on the central nervous system, heart, and brain. 17 indeed, t3 and t4 also provide feedback to the brain and anterior pituitary gland to regulate trh and tsh.18 subclinical conditions have subtle manifestations and may mimic other diseases, 19 and, among patients taking thyroid medication, only 60% were within the normal range of tsh. 20 in short, modest tsh fluctuations corresponded to physiological changes affecting patient health. 21 thyroid dysfunction is common, often undetected, and may be associated with adverse health outcomes. 22 identifying thyroid disease is challenging because symptoms often develop so subtly that they go unnoticed. 23 the difficulty with many studies lies in the variable disease state definitions, where poorly defined populations are studied with limited thyroid functional measures. 24 additionally, studies from various countries differ in their reported estimates for both hypothyroidism and hyperthyroidism. 25 thyroxine (t4) is a hormone the thyroid gland secretes into the bloodstream. thyroxine plays a crucial role in heart function, metabolism control, brain development, bone health, and muscle control. 26 distinctly, thyroxine t4 contains four iodine atoms per molecule. 27 ————————————————————————————— 14. id. at 5; see also kerry richard et al., sulfation of thyroid hormone and dopamine during human development: ontogeny of phenol sulfotransferases and arylsulfatase in liver, lung, and brain, 86 j. clinical endocrinology & metabolism 2734, 2735 (2001). 15. see appendix a. hypothalamic-pituitary-thyroid axis model for thyroid control loop. 16. squire et al., supra note 8, at 910 (the hypothalamic hormone involved in this function is thyrotropin-releasing hormone, produced by a group of cells in a specific nucleus in the hypothalamus, the paraventricular nucleus). 17. id. 18. id. at 909; see also substituted anilide ligands for the thyroid receptor, u.s. patent no. 7,342,127 (filed mar. 11, 2008) (thyroid hormones are currently used primarily as replacement therapy for patients with hypothyroidism). 19. heuck et al., supra note 3, at 9. 20. canaris et al., supra note 2, at 526. 21. id. 22. id. 23. id. at 527. 24. id. at 526; see also massolt, supra note 6, at 49 (“thyroid peroxidase is the major autoantigen and tpo antibodies are present in almost all patients with autoimmune hypothyroidism and precede the clinical phase of autoimmune hypothyroidism by many years.”). 25. canaris et al., supra note 2, at 526. 26. michelle so et al., hypothyroidism: investigation and management, 41 austl. fam. physician 556, 559 (2012). 27. heuck et al., supra note 3, at 5; see also am. thyroid ass’n, supra note 7, at 4 (the main hormone made by the thyroid is thyroxine, also called t4 because it contains four iodine molecules). 2024] inventions and patents for treating 281 thyroid disease figure 1 – thyroxine molecule as blood flows through the pituitary gland, cells measure t4 levels to determine set point accuracy. 28 the pituitary cells communicate with the thyroid through tsh secretion. 29 when t4 levels are at a set point,30 the pituitary gland sends out enough tsh to tell the thyroid to maintain homeostasis. 31 if the t4 levels get low, the pituitary gland releases more tsh, telling the thyroid to make more t4. 32 conversely if t4 are high, the pituitary gland releases less tsh to slow production. 33 for some patients, thyroxine replacement may be beneficial where tsh levels are elevated however, this option remains controversial. 34 indeed, t3 has greater biological activity than t4 comparatively.35 t4 converts to the active triiodothyronine (t3) within cells and peripheral tissues by deiodinases. 36 as such, in contrast to t4, the t3 molecule contains three iodine atoms.37 ————————————————————————————— 28. am. thyroid ass’n, supra note 7, at 10. 29. id. 30. see am. thyroid ass’n, supra note 7, at 8 (a set point is a predetermined hormone level). 31. id. at 10. 32. id. 33. so et al., supra note 26, at 556 (“the significance of elevated tsh associated with thyroid hormones within normal range is controversial; thyroxine replacement may be beneficial in some cases.”). 34. id. at 561. 35. squire et al., supra note 8, at 911. 36. heuck et al., supra note 3, at 5 (once in the bloodstream, thyroxine travels to the body’s organs, where it is converted to an active form, triiodothyronine t3). 37. id. indiana health law review [vol. 21:277 282 figure 2 – triiodothyronine molecule t3 is the physiologically active thyroid hormone. 38 it controls myocardium properties, heart rate, and vascular function. 39 in fact, t3 affects almost every process in the body.40 interestingly, one report suggests the thyroid gland produces t3 directly.41 although, thyroid disease is typically not treated with t3 supplementation. however, some researchers speculate a t4 and t3 combination might be better. 42 molecular structures are important because clinical effects resulting from thyroid hormone imbalance are observable at the cellular level. 43 thyroid diseases are influenced by endocrine physiology, particularly where abnormal thyroid hormone concentrations affect organ function resulting in clinical symptoms. 44 a. hypothyroidism hypothyroidism is a “commonly clinically diagnosed condition describing a thyroid hormone deficiency.”45 if left untreated, hypothyroidism can lead to ————————————————————————————— 38. maynika rastogi & stephen lafranchi, congenital hypothyroidism, 5 orphanet j. rare diseases 1, 12–13 (2010), https://doi.org/10.1186/1750-1172-5-17 [https://perma.cc/z542hdel] (although t3 is the biologically active form of the hormone, most t3 in the brain is formed from local deiodination of t4; thus, t3 replacement is not needed for normal neurologic functioning). 39. massolt, supra note 6, at 33. 40. heuck et al., supra note 3, at 5. 41. institute for quality and efficiency in health care, how does the thyroid gland work?, nat’l libr. of med. (nov. 17, 2010), https://www.ncbi.nlm.nih.gov/books/nbk279388/ [https://perma.cc/42ss-k6r8] (they are made in what are known as the follicular epithelial cells of the thyroid). 42. am. thyroid ass’n, supra note 7, at 17. 43. massolt, supra note 6, at 9. 44. id. 45. chaker et al., hypothyroidism, 8 nature rev. disease primers (2022). https://perma.cc/42ss-k6r8 https://www.ncbi.nlm.nih.gov/books/nbk279388 https://perma.cc/z542 https://doi.org/10.1186/1750-1172-5-17 2024] inventions and patents for treating 283 thyroid disease serious adverse health effects on multiple organ systems, with the cardiovascular system as the most robustly studied target. 46 an estimated 2-3% of americans have clinical hypothyroidism and 10-15% have sub-clinical hypothyroidism. 47 in other words, roughly 6,600,000 to 9,900,000 americans have severe hypothyroidism, while 33,000,000 to 49,500,000 americans have mild hypothyroidism. further, more than half of people with hypothyroidism do not know they have it. 48 approximately 10-15% of patients with hypothyroidism display significant psychological impairment. 49 there are several types of hypothyroidism. for example, congenital hypothyroidism (ch) is defined as thyroid hormone deficiency present at birth.50 ch describes an organism with insufficient thyroid hormone during early neonatal development. 51 thyroid hormone deficiency at birth is mostly caused by a problem with the gland’s physical development or impaired thyroid hormone biosynthesis. 52 a second example is autoimmune hypothyroidism, which is characterized by elevated serum tsh with reduced free t4 levels, serum antibodies against thyroid antigens, and reduced echogenicity in the thyroid sonogram. 53 in fact, thyroid autoimmunity is one of the most common causes of hypothyroidism, hashimoto’s disease. 54 hashimoto thyroiditis is also impacted by environmental factors including vitamin d and selenium deficiency, and moderate alcohol intake.55 hypothyroidism, has several causes. 56 for example, the thyroid must have iodine to make thyroid hormone. 57 too much iodine may also cause and worsen hypothyroidism. 58 in the western world, hypothyroidism is most caused by autoimmune chronic lymphocytic thyroiditis. 59 however, worldwide, iodine deficiency is the most common cause for hypothyroidism, although it is a rare cause in the united states.60 hypothyroid symptoms include anxiety, physical or muscular weakness, ————————————————————————————— 46. id. 47. am. thyroid ass’n, supra note 7, at 4. 48. id. 49. massolt, supra note 6 , at 9. 50. rastogi & lafranchi, supra note 38, at 1. 51. squire et al., supra note 8, at 912. 52. rastogi & lafranchi, supra note 38, at 1 (“in iodine sufficient countries, 85% of congenital hypothyroidism is due to thyroid dysgenesis.”). 53. massolt, supra note 6, at 49. 54. id. at 12 (“it is the most common organ-specific autoimmune disorder with an estimated prevalence of 2%, with a higher prevalence in women and depending on iodine intake.”). 55. chaker et al., supra note 45, at 2. 56.’680 patent. 57. am. thyroid ass’n, supra note 7, at 8. 58. id. 59. so et al., supra note 26, at 556 (“a thyroid peroxidase antibody assay is the only test required to confirm the diagnosis of autoimmune thyroiditis.”). 60. am. thyroid ass’n, supra note 7 at 8. indiana health law review [vol. 21:277 284 heart disease, constipation, depression, and weight gain. 61 further, many patients report ongoing symptoms such as muscle aching and tiredness. 62 additionally, hypothyroidism is more common in biological females than biological males, and more common in the elderly than young. 63 in fact, most disease related deficiencies can be mitigated by newborn infant screening and thyroid hormone replacement. 64 still, a completely unsupported, yet pervasive claim in modern medicine is hypothyroidism cannot be cured. 65 but, the truth is whether we think we can or we think we can’t; we’re probably right. b. hyperthyroidism hyperthyroidism describes an excess thyroid hormone causing the pituitary gland to produce less tsh. 66 tsh measurement is the base for the hyperthyroidism diagnosis. 67 in short, low tsh and high t3 and t4 corresponds to hyperthyroidism. 68 thyroid gland overactivity has several causes. 69 hyperthyroidism symptoms include sweating, heart palpitations, and weight loss.70 additional symptoms include increased body temperature, decreased body weight, decreased serum cholesterol, increased stroke volume, and arrhythmia. 71 excessive thyroid hormone, can also result in symptoms such as tremor, nervousness, insomnia, and impairments in memory and concentration.72 hyperthyroidism is characterized by excessive secretion of thyroid hormones; the most common cause is the autoimmune disorder graves’ disease. 73 graves’ hyperthyroidism is a hypermetabolic state, affecting virtually every tissue and cell in the body and leads to cardiovascular dysfunction and death. 74 graves’ hyperthyroidism is treated by surgical resection, 75 therapeutic ————————————————————————————— 61. massolt, supra note 6, at 123. 62. id. at 9. 63. so et al., supra note 26, at 556 (“unless contraindicated, iodine supplementation should be prescribed routinely in women planning a pregnancy.”). 64. id. (“the initial screening for suspected hypothyroidism is thyroid stimulating hormone.”). 65. am. thyroid ass’n, supra note 7, at 12. 66. heuck et al., supra note 3, at 5. 67. id. 68. ‘680 patent. 69. id. 70. massolt, supra note 6, at 9. 71. thyroid hormone receptor ligand, medicinal compositions containing the same & use thereof, u.s. patent no. 7,230,031 (issued june 12, 2007). 72. squire et al., supra note 8, at 912. 73. inverse agonists & neutral antagonists for the tsh receptor, u.s. patent no. 9,206,154 (issued dec. 8, 2015). 74. id. (graves’ hyperthyroid patients as diagnosed by computerized tomographic scan). 75. am. thyroid ass’n, supra note 7, at 7 (“some people with thyroid nodules, thyroid cancer, or graves’ disease need to have part or the entire thyroid removed.”). 2024] inventions and patents for treating 285 thyroid disease doses of radioactive iodine, or pharmacologically. 76 however, each of these treatment modalities has side effects associated with it. 77 often, both hypothyroidism and hyperthyroidism are treatable with lifelong synthetic thyroid hormone replacement. 78 part ii explores thyroid disease through the patent system and the development of legal claims to new inventions for treating thyroid disease. c. diagnostics diagnostics refers to the process by which disease is identified. for patients, diagnosis of thyroid disease is often conducted through a combination of patient symptoms and biochemical testing of thyroid function. table 1 there are two primary immunoassays used to diagnose thyroid dysfunction. first, tsh levels are measured. if levels do not fall within normal range, circulating free forms of t3 and t4 in patient blood are measured. tpoab or anti-thyroglobulin antibodies are also markers used to detect thyroid autoimmunity.79 table 2 80 depending on abnormalities and other symptoms, patients may be diagnosed with a variety of thyroid diseases, including thyroid cancer, 81 hypothyroidism, and hyperthyroidism. ————————————————————————————— 76. ‘154 patent. 77. id. 78. ‘680 patent. 79. see chaker et al., supra note 45; see also nobuyuki takasu & jaeduk yoshimura noh, hashimoto’s thyroiditis: tgab, tpoab, trab and recovery from hypothyroidism, 4 expert rev. clinical immunology 221 (2008). 80. see appendix d. symptoms for thyroid disease. 81. the four main kinds of thyroid cancer are papillary, follicular, medullary, and anaplastic. however, thyroid cancer is relatively far rarer than hyperthyroidism and hypothyroidism. indiana health law review [vol. 21:277 286 iii. inventions and patents a patent is a form of legal protection for new and useful technologies. 82 it provides the holder the legal right to prohibit others from using, making, or selling an invention.83 the united states patent and trademark office (“uspto”) reviews applications to determine whether a claimed invention is: (1) statutory subject matter; (2) useful; (3) novel; (4) would not be considered obvious by a hypothetical person of ordinary skill in the field; and (5) described well enough that those in the field can make and use the invention. 84 notre dame law professor stephen yelderman argues the united states’ patent system’s central goal is to provide adequate incentive to innovators to publish their inventions in exchange for rights. 85 however, practically speaking the united states patent office has largely abandoned this goal and instead focuses on stopping technical progress and promoting stagnation by reviewing applications from large companies fast and simply ignoring inventions filed by small businesses and inventors for many years despite being grossly overfunded and overstaffed.86 as such, in conferring the exclusive right to discoveries to its inventors, patents confer a temporary monopoly to the holder. 87 ————————————————————————————— 82. john palfrey, intellectual property strategy 55 (mit press 2012). 83. stephen yelderman, the value of accuracy in the patent system, 84 u. chi. l. rev. 1217, 1270 (2017); see also u.s. const. art. i, § 8, cl. 8 (providing the constitutional basis for patents, “[t]he congress shall have the power…to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”). 84. see 35 u.s.c. § 101 (the first element of the statutory requirements, statutory subject matter, includes any new process, machine, manufacture, or composition of matter, or any new and useful improvement thereof); see also 35 u.s.c. § 112. 85. in other words, the patent statute promotes technological progress through the monopoly it offers for the creation and disclosure of something new. see yelderman, supra note 83, at 1263, 1670 (the system congress created provides a delicate balance; in exchange for monopoly rights, the innovator must provide a description of how to make and use the invention); see also max stul oppenheimer, patents 101: patentable subject matter and separation of powers, 15 vand. j. ent. & tech. l. 1, 8 (2012). 86. budget and financial information, u.s. pat. & trademark off. (2022), https://www.uspto.gov/about-us/performance-and-planning/budget-and-financial-information [https://perma.cc/slz6-jg9a] (the uspto budget will increase to $4.25 billion in 2022 and patent examiners make commonly make between $100,000 and $200,000 per year). 87. in short, a patent awards the exclusive rights to use and profit from an invention to the holder, backed by the government. see bryce c. pilz, student intellectual property issues on the entrepreneurial campus, 2 mich. j. private equity & venture cap. l. 1, 16 (2012); see also andrew beckerman-rodau, the problem with intellectual property rights: subject matter expansion, 13 yale j. l. & tech. 36, 55 (2010–2011) (the uspto’s granting of patent rights provides typical property rights, including the right of the patent owner to exclude others from making, using, offering for sale, or selling the invention throughout the united states or importing the invention into the united states). https://perma.cc/slz6-jg9a https://www.uspto.gov/about-us/performance-and-planning/budget-and-financial-information 2024] inventions and patents for treating 287 thyroid disease a. treatments the treatment options available for thyroid disease depend heavily on the nature and extent to which the body produces and regulates thyroid hormone levels.88 for example, hypothyroidism is usually treated by replacing the hormone the thyroid fails to produce with synthetic hormone. 89 by contrast, hyperthyroidism may be treated by surgically destroying part of the thyroid gland. 90 in all cases, proper treatment for thyroid disease is vital to patient health. 91 thyroid hormone imbalance can have deleterious and disastrous consequences including extreme anxiety, depression, and fatigue. 92 medication options for treating thyroid disease range depending on the clinical diagnosis and individual patient response. for hypothyroidism, physicians often prescribe synthetic thyroxine. 93 synthetic thyroxine pills contain hormone like the t4, which a healthy thyroid makes naturally. 94 in other words, synthetic thyroxine replaces the hormone that the thyroid can no longer make. 95 oral levothyroxine (lt4) is the standard therapy for patients with hypothyroidism. 96 both brand-name and generic lt4 tablets are available. 97 ————————————————————————————— 88. levothyroxine compositions & methods, u.s. patent no. 6,555,581 (filed feb. 15, 2002) (“thyroid hormone replacement therapy is a chronic and lifetime endeavor for treatment. thyroid hormone dosage must be established for each patient individually.”). 89. am. thyroid ass’n, supra note 7, at 12; see also squire et al., supra note 8, at 912 (“for example, hypothyroidism generally is treated by thyroid hormone replacement.”). 90. ‘680 patent. 91. ‘127 patent (“in hyperthyroidism, these hormones lead to weight loss, hypermetabolism, lowering of serum ldl levels, cardiac arrhythmias, heart failure, muscle weakness, bone loss in postmenopausal women, and anxiety.”). 92. ‘581 patent; see also am. thyroid ass’n, supra note 7, at 18 (“the most common symptoms of too much thyroid hormone are fatigue, the inability to sleep, greater appetite, nervousness, shakiness, feeling hot when other people are cold, muscle weakness, shortness of breath, and a racing, skipping heart.”). 93. storage stable thyroxine active drug formulations & methods for their production, u.s. patent no. 6,936,274 (filed may 22, 2003). 94. am. thyroid ass’n, supra note 7, at 12. 95. id. at 13. 96. there are three major problems with daily oral levothyroxine for treating hypothyroidism: (1) fluctuation in ingestion times and surrounding dietary conditions causes metabolic imbalance; (2) fluctuation in patient needs causes metabolic imbalance; and (3) fluctuation in brand name may cause metabolic imbalance. the disclosed invention solves these three problems, providing methods for curing hypothyroidism with automatic monitoring and corrective release to maintain metabolic homeostasis. see nienke bolk et al., effects of evening vs morning levothyroxine intake, 170 archives internal med. 1, 1 (2010). 97. see appendix c. levothyroxine tablet information; see also am. thyroid ass’n, supra note 7, at 11 (in the united states, thyroxine pills contain only t4. however, some researchers speculate whether a combination of t4 and t3 might be better for treating patients. while there have been some early studies, the results have not been particularly promising.). indiana health law review [vol. 21:277 288 figure 3 98 variations in hyperthyroidism manifestations and corresponding cardiovascular concerns limit treatment options for hypothyroid symptoms. 99 however, drug therapy for hyperthyroidism typically involves antithyroid drugs. 100 two main antithyroid drugs are propylthiouracil and methimazole, which inhibit organic iodine binding. 101 additionally, in some cases treatment with glucocorticoids102 has shown limited effect in treating hyperthyroidism. 103 yet, key problems persist. for example, pharmacists often switch between lt4 formulations which have been determined bioequivalent. 104 however, even small differences between lt4 formulations can cause significant changes in tsh levels. 105 changes may cause clinical symptoms, some of which can be caused by inactive ingredients. 106 as such, pharmaceutical swapping is a particular concern in vulnerable populations, including elderly, pregnant, and pediatric patients. 107 an important area for improvement is the development of combination therapy. one problem with current treatment options is they only include t4. ————————————————————————————— 98. ‘581 patent. 99. ‘127 patent (“prior attempts to utilize thyroid hormones pharmacologically to treat these disorders have been limited by manifestations of hyperthyroidism, and in particular by cardiovascular toxicity.”). 100. method for treating thyroid disorders with a botulinum toxin, u.s. patent no. 6,740,321 (filed nov. 2, 2000). 101. ‘321 patent. 102. glucocorticoids are corticosteroids, a class of steroid hormones. glucocorticoids bind to the glucocorticoid receptor in cells. 103. ‘154 patent. 104. salvatore benvenga & allan carlé, levothyroxine formulations: pharmacological and clinical implications of generic substitution, 36 advances in therapy 59, 59 (2019). (“in the us, the food and drug administration (fda) has developed a protocol for establishing bioequivalence of lt4 formulations based on serum thyroxine (t4) levels after a single oral dose administered to healthy volunteers.”). see also am. thyroid ass’n, supra note 7, at 12. (“this is because generic drugs can be substituted with other generic drugs from different manufacturers of levothyroxine each time you get your prescriptions refilled.”) 105. benvenga & carlé, supra note 104. 106. see appendix d. see also benvenga & carlé, supra note 104. (patients should be maintained on the same lt4 preparation if possible. if the lt4 preparation is changed, tsh levels should be evaluated and, if necessary, the dose of lt4 adjusted.) 107. benvenga & carlé, supra note 104. 2024] inventions and patents for treating 289 thyroid disease however, recent research shows that the thyroid produces both t4 and t3. 108 most of the thyroid hormone production is t4, but there is some t3 produced as well. in fact, treating patients with both t4 and t3 at the right ratio would help with treatment effectiveness. for example, t3 supplementation helps with depression.109 b. data healthcare will be the field having the most impact on humanity’s future and as such is also the ripest for breakthrough innovation. this is particularly true for the thyroid, which is often ignored as part of a larger field in endocrinology. the confluence of healthcare and innovation is well presented through the patent system. any new and useful process or machine is a patentable invention. 110 this part explores inventions and patents for treatments to thyroid diseases. the thyroid patent dataset was aggregated to contribute the first empirical analysis for patents relating to the thyroid gland’s functionality in the hypothalamic-pituitary-thyroid axis hormonal control loop. the total thyroid patent dataset currently contains data for 627 patents, and is an iteratively evolving, dynamic software. figure 4 111 ————————————————————————————— 108. cristiane gomes-lima et al., can reverse t3 assay be employed to guide t4 vs. t4/t3 therapy in hypothyroidism?, frontiers in endocrinology (dec. 11, 2019), https://doi.org/10. 3389/fendo.2019.00856 [https://perma.cc/mm7h-ge9e]. (“in humans, a normal thyroid gland produces ~85 mcg of t4 and 6.5 mcg of t3 daily (1). thus, the ratio of t4:t3 that is directly secreted from the thyroid gland is around 13:1.”) 109. kenneth ain & m. sara rosenthal, the complete thyroid book 262 (2011). 110. 35 u.s.c. § 101. 111. brian s. haney, thyroid patents (2020). (the information contained in this chart was prepared by the author with information from the united states patent and trademark office. a copy of the data is on file with the author.) https://perma.cc/mm7h-ge9e https://doi.org/10 indiana health law review [vol. 21:277 290 patents with claims including the two major thyroid diseases, hypothyroidism (131) and hyperthyroidism (123) are included in the dataset because they are problems that occur in the thyroid control loop; and the aim for inventions is to solve these problems. further, patents with claims including the two major thyroid hormones, thyroxine t4 (256) and triiodothyronine t3 (117) are included in the dataset because they are the effective output for the thyroid control loop. the goal for the dataset is to provide access to key information relating to treatments for thyroid disease. the dataset was collected from the uspto database through structured human techniques in compliance with uspto policy. 112 importantly, the uspto severely restricts public access to patent data, which as a policy must end. 113 the initial terms were selected to pinpoint patents for thyroid disease and thyroid hormone by searching the legal claims for key terms. the dataset is currently limited to patents granted between 1999-2019. the thyroid dataset is stored in two formats, xls and csv, for processing. figure 5 depicts analysis for claims in the thyroid patent dataset. 114 one theory is valuable patents contain more claims than ordinary patents. 115 the intuition behind this reasoning is consistent with the uspto fee structure. 116 however, there are exceptions to this theory, where patents with fewer claims are more valuable. ————————————————————————————— 112. uspto, terms of use for uspto websites (2020), https://www.uspto.gov/terms-useuspto-websites [https://perma.cc/us9n-v284]. see also veronica root, coordinating compliance incentives, 102 cornell l. rev. 1003, 1029 (2017), https://papers.ssrn.com/sol3/ papers.cfm?abstract_id=2867048 [https://perma.cc/tvw6-ph2g]. (“governmental enforcement agencies and actors are also subject to the information and coordination complexities that confront many regulatory agencies within the current administrative state. importantly, these information and coordination challenges may lead to a responsibility vacuum when considering issues of corporate recidivists.”). 113. id. the uspto refuses to allow inventors, small business, and researchers access to key patent data necessary to promote technical progress and innovation. instead, the uspto claims to make data available to the public through a contract with reedtech, a lexis subsidiary. however, the data the uspto provides is useless for inventors, small businesses, and researchers because it is stored in bulk. as a result, processing the data requires expensive industrial scale computers only accessible to large corporations. this policy could easily be fixed by simply making uspto data available through a cloud computing model, expanding bandwidth capability, and saving money. yet, resolution is unlikely because the uspto’s financial incentives are to exclude non-corporate entities from the market. 114. alan c. marco, et al., patent claims and patent scope, u.s. patent and trademark office (econ. working paper series, 9, oct. 2016), https://papers.ssrn.com/sol3/papers. cfm?abstract_id=2844964 [https://perma.cc/57l7-dpyb] (claims represent the legal bounds of the invention). 115. john r. allison, et al., valuable patents, 92 geo. l.j. 435, 438 (2004). 116. uspto, uspto fee schedule (2022), https://www.uspto.gov/learning-andresources/fees-and-payment/uspto-fee-schedule [https://perma.cc/pt46-5gba]. see also leahysmith am. invents act, pub. l. no. 112-29 (2011) (see section 11 fees for patent services, which de facto prevents inventors living in poverty from being able to patent or protect their inventions). https://perma.cc/pt46-5gba https://www.uspto.gov/learning-and https://perma.cc/57l7-dpyb https://papers.ssrn.com/sol3/papers https://perma.cc/tvw6-ph2g https://papers.ssrn.com/sol3 https://perma.cc/us9n-v284 https://www.uspto.gov/terms-use 2024] inventions and patents for treating 291 thyroid disease figure 5 117 owned by ilypsa, inc., u.s. patent 8,349,305, crosslinked amine polymers, contained the maximum 183 claims. 118 the minimum was shared by two patents, u.s. patent 9,550,838, dock-and-lock (dnl) complexes for therapeutic and diagnostic use and u.s. patent 9,085,510, preparation of organic compounds for enhanced reactivity, each containing one claim. 119 a second theory is valuable patents tend to cite more prior art. 120 this reasoning is commensurate with time and money spent on patent search, research, and drafting – each of which positively corresponds with cost. figure 6 models the prior art citations for the thyroid patent dataset. ————————————————————————————— 117. brian s. haney, thyroid patents (2020). (the information contained in this chart was prepared by the author with information from the united states patent and trademark office). (a copy of the data is on file with the author). 118. crosslinked amine polymers, u.s. patent no. 8,349,305 to cheng, et al. (filed jan. 8, 2013). 119. dock-and-lock (dnl) complexes for therapeutic and diagnostic use, u.s. patent no. 9,550,838, to chang, et al. (filed jan. 24, 2017). see also preparation of organic compounds for enhanced reactivity, u.s. patent no. 9,085,510 to latham (filed july 21, 2015). 120. allison, supra note 115. indiana health law review [vol. 21:277 292 figure 6 121 yet, a contrarian may argue fewer prior art citations are more valuable insofar as the invention is more novel. the minimum in the thyroid patent dataset, owned by the johns hopkins university, u.s. patent no. 9,039,994, biomarkers for myocardial ischemia, cited no prior art.122 by contrast, the patent with maximum citation count is owned by sio2 medical products, inc., u.s. patent no. 9,662,450, plasma or cvd pre-treatment for lubricated pharmaceutical package, coating process and apparatus, which cited 1,445 prior art.123 a third factor which may be considered is a patent’s inventorship. a common argument is that more inventors and higher inventor prestige correspond with higher patent quality because more intelligence and time were committed to the patent.124 ————————————————————————————— 121. haney, supra note 111. 122. biomarkers for myocardial ischemia, u.s. patent no. 9,039,994 to van eyk, et al. (filed may 26, 2015). 123. plasma or cvd pre-treatment for lubricated pharmaceutical package, coating process, and apparatus, u.s. patent no. 9,662,450 to jones, et al. (filed may 30, 2017). 124. r. polk wagner, understanding patent-quality, 157 u. pa. l. rev. 2135, 2138 (2009) (prestige and time may also correlate with the capacity of a granted patent to meet the statutory standards of patentability – most importantly, to be novel, non-obvious, and clearly and sufficiently described.). see also heather hamel, valuing the intangible: mission impossible? an analysis of the intellectual property valuation process, 5 cybaris an intell. prop. l. rev. 183, 187 (2014). 2024] inventions and patents for treating 293 thyroid disease figure 7 125 owned by otsuka pharmaceutical co., u.s. patent 8,420,623, n, nsubstituted 3-aminopyrrolidine compounds useful as monoamines reuptake inhibitors, listed twenty-two inventors. 126 however, one counterargument is estimations based on inventorship may overlook inventions by previously unknown inventors which took substantial time and effort. in other words, similar to the way in which politicians attack one another personally rather than underlying policies and ideas, patent valuations based on inventorship fall victim to the ad hominem fallacy.127 c. claims claims are the most important part of a patent because they declare the invention128 because claims are the only part of the patent that can be infringed.129 the uspto issues patents for claims it determines satisfy the statutory requirements. 130 further, a challenge to an issued patent will succeed if the challenger can show that any of the requirements have not been met. 131 further, courts construe patent claims by starting with the plain meaning, as the ————————————————————————————— 125. haney, supra note 111. 126. n, n-substituted 3-aminopyrrolidine compounds useful as monoamines reuptake inhibitors, u.s. patent no. 8,420,623, to kurimura, et al. (filed april 16, 2013). 127. the ad hominem fallacy refers to logical arguments relating to a person, rather than the position they are maintaining. 128. mark a. lemley, the changing meaning of patent claim terms, 104 mich. l. rev. 101 (2005). 129. kevin f. o’malley, et. al., 3a fed. jury prac. & instr. § 158:41 (6th ed. 2019). 130. max stul oppenheimer, patents 101: patentable subject matter and separation of powers, 15 vand. j. ent. & tech. l. 1, 4 (2012). 131. id. indiana health law review [vol. 21:277 294 terms are understood by a person having ordinary skill in the art. 132 three claim drafting considerations crucial to thyroid patents are: non-obviousness, novelty, and scope. the non-obviousness doctrine seeks to ensure patents are granted only for technologically significant advances to stimulate useful innovation. 133 a patent claim is invalid “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art.”134 nyu law professor jeanne fromer explains, “the non-obviousness doctrine seeks to ensure that patents are granted only for technologically significant advances to foster the patent system’s goal of stimulating useful innovation.”135 the statute requires that obviousness be judged from the perspective of the person having ordinary skill in the art. 136 consider u.s. patent no. 6,740,680, pharmaceutical compositions to tetrac and methods of use thereof, which claims: 1. a method for suppressing tsh secretion while reducing or avoiding the thyromimetic stimulation of peripheral tissues induced by a dose of l-thyroxine which produces an equivalent tsh-suppressive effect comprising administration of a pharmaceutical composition comprising tetrac, or a pharmaceutically acceptable salt thereof, admixed with a pharmaceutically acceptable carrier. 137 here, the non-obvious advance comprises two elements: suppressing tsh secretion and a pharmaceutical composition including tetrac 138 and other compounds. until this patent, the state-of-the-art reflected that levothyroxine139 was considered the only pharmaceutical composition capable of treating thyroid disease. non-obviousness is a question of law, 140 but it relies upon factual inquiries ————————————————————————————— 132. lemley, supra note 128, at 102. 133. jeanne c. fromer, the layers of obviousness in patent law, 22 harv. j. of l. & tech. 75 (2008). (“the non-obviousness doctrine seeks to ensure that patents are granted only for technologically significant advances to foster the patent system’s goal of stimulating useful innovation.”). 134. 35 u.s.c. § 103 (2013). 135. fromer, supra note 133. 136. endress + hauser inc. v. hawk meas. sys. pty., 122 f.3d 1040, 1042 (fed. cir. 1997) (analogizing the person having ordinary skill in the art to the reasonable man in criminal law). see also dean alderucci, the automation of legal reasoning: customized ai techniques for the patent field, 58 duq. l.r. 50 (2020). 137. pharmaceutical compositions to tetrac and methods of use thereof, supra note 4. 138. maria e. everts et al., uptake of 3,3’,5,5’-tetraiodothyroacetic acid and 3,3’,5’triiodothyronine in cultured rat anterior pituitary cells and their effects on thyrotropin secretion, 136 endocrinology 4454 (1995). 139. levothyroxine compositions and methods, supra note 88. 140.graham v. john deere co., 383 u.s. 1, 17-18 (1966). 2024] inventions and patents for treating 295 thyroid disease surrounding the differences between the prior art and the application’s claims. 141 the goal for the non-obviousness requirement is to limit patents to only those inventions representing a sufficiently large advance over previously known technology. 142 to one skilled-in-the-art, the degree to which an invention advances the art may be entirely subjective. 143 and yet, in addition to nonobvious, patentable claims must also be for something new. a second component for patent claims is that they must claim a novel invention. 144 in fact, patents are validated technical advancements for new products and innovation services. 145 the law requires that an invention be novel, or new, to be granted a patent. 146 consider u.s. patent. no. 7,493,172, methods and systems for stimulating a nerve originating in an upper cervical spine area to treat a medical condition, which claims: 1. a method of treating a medical condition of a patient, said method comprising: applying at least one stimulus to a target nerve within a patient with an implanted system control unit in accordance with one or more stimulation parameters configured to treat said medical condition; wherein said target nerve comprises a nerve originating in an upper cervical spine area of said patient and wherein said medical condition comprises at least one or more of ————————————————————————————— 141. brian s. haney, patents for nlp software: an empirical review, 18 iup j. knowledge mgmt. 27, 52 (2020) (one idea is to measure these factual considerations objectively to identify probabilistic correlation. for example, the relationship between the prior art and the patent could be objectively measured according to the relative syntactic similarity between the prior art claims and patent claims). 142. sensonics, inc. v. aerosonic corp., 81 f.3d 1566, 1570 (fed. cir. 1996). 143. oliver wendell holmes, jr., the path of the law, 10 harv. l. rev. 457, 465 (1897) (one can give any conclusion a logical form). see also brian s. haney, applied natural language processing for law practice, 2020 b.c. intell. prop. & tech. f. 1, 42 (2020) (“as a result, language is often peripheral in the practice of law”). 144. sarah murphy, heads i win, tails you lose: the “expense” of a de novo review of uspto decisions, 60 b.c.l. rev. ii.-197 (2019) (“the united states patent and trademark office (the “uspto”) may deny patent applications and trademark registrations to applicants who do not meet the necessary requirements.”). 145. m. c. guardo & k. r. harrigan, shaping the path to inventive activity: the role of past experience in r&d alliances, 41 j. technol transf. 250, 258, (2016) (“not only do they represent an externally validated measure of technological novelty with a clear economic significance, but their correlation with other measures of technological performance, such as new products or innovation counts, has been vetted.”). 146. stefania fusco, trips non-discrimination principle: are alice and bilski really the end of npes?, 24 tex. intell. prop. l.j. 131, 139 (nov. 30, 2016), https://papers. ssrn.com/sol3/papers.cfm?abstract_id=2653463 [https://perma.cc/b9hp-28qp] (“the accusations were primarily directed at the quality of business method patents and, specifically, the lack of novelty in their inventions.”). see also mark a.lemley & mark p. mckenna, scope, 57 wm. & mary l. rev 2197, 2240 (2015) (accessed at https://papers.ssrn.com/sol3/ papers.cfm?abstract_id=2660951[https://perma.cc/j2g3-uyhr]) (“because patent law requires that an invention be novel and non-obvious, it should be clear that a patent owner is not entitled to sue someone for using technology that existed before she ever “invented” it.”). https://papers.ssrn.com/sol3 https://perma.cc/b9hp-28qp https://papers indiana health law review [vol. 21:277 296 an autoimmune disease, hyperthyroidism, and hypothyroidism. 147 the claim is a method for treating a medical condition, wherein the medical condition includes an autoimmune or thyroid disease. the claim’s novelty is in the applying a stimulus to the nervous system according to pre-defined parameters. the invention highlights the critical relationship between the thyroid and nervous system. 148 yet, novelty in thyroid technologies and treatments is not a difficult task to achieve due to the currently shallow limits in human knowledge. in other words, very little is known about the thyroid, providing opportunity for innovation. the backdrop against which something is new is a critical aspect for the novelty requirement. larissa bifano, a partner with dla piper explains, “in addition to the technical details, establishing a narrative of the inventive concept can greatly help practitioners during the prosecution stage.”149 professor elona marku at the university of cagliari in italy is developing objective measures for novelty. in fact, they have developed a quality formalism for measuring patent originality, which may be modified to measure novelty. 150 according to professor marku, the algorithmic measure “captures the breadth of the technological knowledge bases that have been synthesized in the focal patent and captures the antecedent technology embodied in each patent.”151 the intuition is that synthesizing divergent ideas is a characteristic for original research.152 a patent’s scope depends on the relevant patent’s defined protectable ————————————————————————————— 147. whitehurst et al., methods and systems for stimulating a nerve originating in an upper cervical spine area to treat a medical condition, u.s. patent. no. 7,493,172 to boston scientific neuromodulation corp. (issued feb 17, 2009). ) 148.. squire et al., supra note 8, at 910. (“thyroid hormone receptors are located throughout the brain, highlighting their importance in central nervous system development and function.”) 149. larissa bifano, et al., protecting ai technologies through patents: a us guide, 3 dla piper (2020), https://www.dlapiper.com/en/us/insights/publications/2020/04/a-us-guideto-protecting-ai-based-inventions/ [https://perma.cc/7jyx-e68g] (“recent case law and us patent office guidance have focused on identifying the technical improvement that results from the artificial intelligence innovation.”). 150. elona marku et al., quantity at expense of quality? measuring the effects of technological m&a on innovation performance 8 col. bus. sch. (2015). the originality algorithm may be modified as follows to measure novelty: 𝑁𝑜𝑣𝑒𝑙𝑡𝑦𝑖 = 1 − ∑ 𝑆𝑖𝑗 2 𝑛𝑖 𝑗=1 where 𝑆𝑖𝑗 represents the backward citations of patent 𝑖 that have class code 𝑗, out of 𝑛𝑖 different patent technology classes during the four-year, pre-acquisition and postacquisition windows, respectively. 151. id. 152. guardo & harrigan, supra note 145. https://perma.cc/7jyx-e68g https://www.dlapiper.com/en/us/insights/publications/2020/04/a-us-guide 2024] inventions and patents for treating 297 thyroid disease rights. 153 the scope question is not limited to validity or infringement. 154 rather, it refers to a range of patent rights protecting monopoly. 155 consider u.s. patent no. 9,980,933, thyroid hormone analogs and methods of use, which claims: 1. a method for treating a condition by promoting angiogenesis, wherein the condition is selected from the group consisting of occlusive vascular disease, coronary disease, erectile dysfunction, myocardial infarction, ischemia, stroke, peripheral artery vascular disorders, wound healing and burns, said method comprising the steps of: formulating a polymer into a nanoparticle, wherein the nanoparticle is less than 200 nanometers, wherein the polymer is polyglycolide, polylactide, or a copolymer thereof; conjugating a thyroid hormone analog to the nanoparticle forming a conjugated thyroid hormone analog; coating a medical device with the conjugated thyroid hormone analog; administering an effective amount of the conjugated thyroid hormone analog to a subject suffering from the condition by inserting the medical device coated with the conjugated thyroid hormone analog into the subject; initiating non-genomic signal transduction pathways at an integrin 𝛼𝜈𝛽3 surface receptor of a cell by contacting the conjugated thyroid hormone analog with the 𝛼𝜈𝛽3 surface receptor, said conjugated thyroid hormone analog does not gain entry to the cell’s interior.156 this claim has a long preamble, but the general rule is the preamble does not limit claim scope. however, this claim is limited by the preamble due to the specificity with which the condition is described, as a selection from a group. an alternative analysis may reveal, this claim contains two transitional phrases, consisting and comprising. typically, comprising 157 is the broadest ————————————————————————————— 153. lemley & mckenna, supra note 146, at 2209 (ip regimes require, not just similarity between the defendant’s and plaintiff’s works, but similarity with respect to the protectable elements. 154. lemley & mckenna, supra note 146, at 2202 (ip regimes require, not just similarity between the defendant’s and plaintiff’s works, but similarity with respect to the protectable elements.) 155. dan l. burk & mark a. lemley, policy levers in patent law, 89 va. l. rev. 1575, 1617 2003). 156. mousa, et al., thyroid hormone analogs and methods of use u.s. patent no. 9,980,933, to mousa, et al., (issued may 29, 2018). 157. mars inc. v. h.j. heinz co., 377 f.3d 1369, 1376, 71 uspq2d 1837, 1843 (fed. cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). see also genentech, inc. v. chiron corp., 112 f.3d 495, 501, 42 uspq2d 1608, 1613 (fed. cir. 1997) (“comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.) (comprising means the invention includes but is not limited to the elements identified in the claim.). indiana health law review [vol. 21:277 298 transitional phrase and consisting of158 is the narrowest. however, this claim is unique because it is arguably two claims. for example, consider if the claim was re-written as one independent claim and one dependent claim 1. a method for treating a condition by promoting angiogenesis, wherein the condition is selected from the group consisting of occlusive vascular disease, coronary disease, erectile dysfunction, myocardial infarction, ischemia, stroke, peripheral artery vascular disorders, wound healing and burns[.] [2. the method of claim 1, the method] comprising the steps of: formulating a polymer into a nanoparticle, wherein the nanoparticle is less than 200 nanometers, wherein the polymer is polyglycolide, polylactide, or a co-polymer thereof; conjugating a thyroid hormone analog to the nanoparticle forming a conjugated thyroid hormone analog; coating a medical device with the conjugated thyroid hormone analog; administering an effective amount of the conjugated thyroid hormone analog to a subject suffering from the condition by inserting the medical device coated with the conjugated thyroid hormone analog into the subject; initiating non-genomic signal transduction pathways at an integrin 𝛼𝜈𝛽3 surface receptor of a cell by contacting the conjugated thyroid hormone analog with the 𝛼𝜈𝛽3 surface receptor, said conjugated thyroid hormone analog does not gain entry to the cell’s interior.159 in this instance, the independent claim would have a broader scope, where the dependent claim has a narrower scope. however, as the claim is written, as one claim, the claim is exceptionally narrow, limited to only to the exact and specified materials and steps described. indeed, the general idea is more words mean narrower claims. 160 some suggest patent law has gaps resulting from conceptual separations in patentability, infringement, and defenses. 161 for example, a party may successfully argue a patent claim means one thing in one context, but something totally different in another. 162 for example, one may argue the claim scope is ————————————————————————————— 158. ppg industries v. guardian industries, 156 f.3d 1351, 1354, 48 uspq2d 1351, 135354 (fed. cir. 1998) (consisting essentially of limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristics of the claimed invention.). 159. mousa, et al., thyroid hormone analogs and methods of use u.s. patent no. 9,980,933, to mousa, et al., (issued may 29, 2018). 160. marco, et al., supra note 114 (“further, this process almost always involves adding words to the claim: modifiers, qualifiers, or other details.”). 161. lemley & mckenna, supra note 146, at 2202 (arguing patent owners can and do exploit these gaps with some regularity. for example, patentees in computer software, have sought broader patent claim interpretation, to the point where many claims are not limited either to a particular computer algorithm or approach or to a particular hardware implementation.). 162. id. 2024] inventions and patents for treating 299 thyroid disease narrow to the examiner and broad to the judge, knowing neither may have knowledge necessary to understanding the underlying invention. 163 ultimately, scope is a term of art and is best understood as a continuous scale. 164 in other words, whether a claim is broad or narrow is a subjective ascription, often based on relative comparison. 165 as such, data is a critical advantage for the modern firm because data defines the targets to which the claim is compared. iii. clinical commercialization the hardest part of inventing new treatments or biotechnologies is commercialization. commercialization is the process of bringing new drugs and biotechnologies to market. 166 the commercialization process can take over ten years in certain circumstances and in fact there are even publicly traded pharmaceutical companies without revenue that have completely failed to commercialize their innovations over the course of a decade. 167 however, given the appropriate strategy, commercialization may happen faster. yet, it is a difficult balance between customer safety and meeting need in the market. a. value probably the most important part of the commercialization process is adding value. the best way to add value is to invent solutions to problems. for example, in the context of thyroid disease there exists a need for value to be added through solutions to both general and narrow forms of thyroid disease. more often, in the context of patent law, value for innovations is calculated when infringement occurs in the context of damages. 168 the patent act states “[u]pon finding for the claimant the court shall award the claimant damages adequate to compensate for the infringement, but in no event less than a reasonable royalty.”169 generally, a patent infringement assessment is based on first determining the meaning in each patent claim and ————————————————————————————— 163. eileen m. herlihy, the ripple effect of seventh amendment decisions on the development of substantive patent law, 27 santa clara comput. & high tech l.j. 333, 343 (2011). 164. brian s. haney, quantum patents, 27 b.u. j. sci. & tech. l. 41, 64(2021). 165. brian s. haney, ai patents: a data driven approach, 19 chi.-kent j. intell. prop. 407, 462 (2020). 166. paul mj, thangaraj h, ma jk. commercialization of new biotechnology: a systematic review of 16 commercial case studies in a novel manufacturing sector. plant biotechnol j. 2015 oct;13(8):1209-20. doi: 10.1111/pbi.12426. epub 2015 jul 3. pmid: 26140440. 167. atyr pharma inc., annual report (form 10-k) (mar. 14, 2024) 168. jennifer l. blouin & melissa f. wasserman, tax solutions to patent damages, 26 tex. intell. prop. l.j. 5 (2018). 169. 35 u.s.c. § 284 (2015). indiana health law review [vol. 21:277 300 second showing the accused infringement meets each claim term. 170 direct infringement is the broadest clause conferring infringement liability in the patent act. 171 in other words, 35 u.s.c. § 271(a) requires the unauthorized use of a patented invention by making, using, offering for sale, selling, or importing the invention. 172 the act clearly states, “[i]f a patent is found to be valid and infringed, its owner is entitled to infringement damages.”173 courts have interpreted the patent act to mean that patent damages come in two primary measures: lost profits and reasonable royalties. 174 lost profits provide the patentee with the profits the patentee would have made but for the infringing sales as damages in litigation. 175 “proving lost profits, however, is not an easy endeavor.”176 the prevailing patentee must prove: (1) demand for the patented product, (2) a lack of alternatives for the product, (3) the patentee’s ability to meet the additional demand, and (4) the foreseeable profits. 177 the second measure for damages is reasonable royalties, which are the dominant damages determination. 178 today, over 80% of all patent damage awards are reasonable royalties. 179 as such, some describe the reasonable royalty model 180 as a historic bedrock technique in patent license valuation. 181 courts typically apply a fifteen factor analysis set out in georgia-pacific corp. v. united states plywood corp to determine reasonable royalty.182 as such, judicial discretion determines questions relating to conflicting evidence for ————————————————————————————— 170. christopher j. white & hamid r. piroozi, drafting patent applications covering artificial intelligence systems, landslide, jan.-feb. 2019, at 10, 14 (the u.s. code generally divides infringement in to two categories: direct infringement and indirect infringement.). 171. 35 u.s.c. § 271(a) (“except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the united states or imports into the united states any patented invention during the term of the patent therefor, infringes the patent.”). 172. tabrez y. ebrahim, artificial intelligence patent infringement (2020) (unpublished draft) (on file with author). 173. blouin & wasserman, supra note 168, at 5. 174.id. 175. id. 176. id. at 6. 177. id. see panduit corp. v. stahlin bros. fibre works, 575 f.2d 1152, 1156 (6th cir. 1978). 178. id. (arguing tax-related transfer prices are useful evidence for calculating reasonable royalty patent damages.) 179. id. 180. mark a. lemley, distinguishing lost profits from reasonable royalties, 51 william & mary l. rev. 655, 669 (2009). (under a reasonable-royalty model, patent law aims to provide patentees with payment for the “rate that would have both compensated patentees and allowed users of the technology to make a reasonable profit.”). 181. amy l. landers, patent valuation theory and the economics of improvement, 88 tex. l. rev. 163, 166 (2009). (patent damages are a make-whole remedy, intended to restore the patentee to the same position as before the infringement. in the context of patent litigation, income models are particularly popular for determining damages.). 182. 318 f. supp. 1116, 1120 (s.d.n.y. 1970). (“a comprehensive list of evidentiary facts relevant, in general, to the determination of the amount of a reasonable royalty for a patent license may be drawn from a conspectus of the leading cases.”). 2024] inventions and patents for treating 301 thyroid disease amount. 183 and, courts inevitably have broad judgment in evaluating the relevant patent value factors. 184 however, there are much better ways to value inventions for new treatments for thyroid disease than damages. a better way to think about calculating value is with options pricing 185 because option valuations reflect a more diverse and accurate economic information source. 186 real options theory can be used to value inventions for thyroid disease to account the value patents add absent infringement, such as security value on corporate balance sheets, as an intellectual asset to attract grant funding and research revenue, or as product for the public good and the associated tax benefits. 187 another option could be biotechnology patents. for example, the option to choose between exclusively commercializing the patented invention or foregoing commercialization altogether adds value to a company insofar as it provides the ability to shape innovation in the market. 188 one of the first steps in framing patents as real options is to define the patent’s market price.189 the patent’s filing fees, and development costs contribute components for the patent ————————————————————————————— 183. general motors corp. v. dailey, 93 f.2d 938, 942 (6th cir. 1937). 184. see georgia-pacific corp. v. united states plywood corp., 318 f. supp. at 1116. 185. real options are a financial derivatives contract creating the right to purchase an underlying asset at a defined price. every option has a price and the decisions available to a company can be characterized as real options and defined in terms of value by elements like exercise price or expiration date. there are five key elements for options : (1) a right but not an obligation, (2) at or before some specified time (3) to purchase a call option, or sell a put option (4) at a prespecified price the exercise price (5) an underlying asset whose price is subject to some form of random variation. see nikitas stamatopoulos, et al., option pricing using quantum computers, 4 quantum 291, 291 (2020), https://arxiv.org/abs/1905.02666. (“options are financial derivative contracts that give the buyer the right, but not the obligation, to buy (call option) or sell (put option) an underlying asset at an agreed-upon price (strike) and timeframe.”) see also andrew chin, teaching patents as real options, 95 n.c. l. rev. 1433, 1441 (2017), http://scholarship.law.unc.edu/nclr/vol95/iss5/4. (“a real option is the right, but not the obligation, to pay a predetermined price to undertake a potentially profitable action in the future.”) see also robert pitkethly, the valuation of patents: a review of patent valuation methods with consideration of option-based methods and the potential for further research, judge inst. working paper (1997), http://users.ox.ac.uk/~mast0140/ejwp0599.pdf. 186. christopher a. cotropia, describing patents as real options, 34 j. corp. l. 1127, 1128 (2009). 187. id. at 1131. 188. maria isabella leone & raffaele oriani, the option value of patent licenses, 2 (2007), https://www.researchgate.net/publication/252398618_the_option_value_of_patent_licenses. (as a consequence, recent attempts in patent valuation efforts have been developed with a real options framework, recognizing uncertainty in patent value.). 189. a technology’s market value is connected to licensing revenues and sales. importantly, patents are a valuable asset class in information and knowledge economies. this is especially true for high-technology and pharmaceutical companies working in the synthetic life space. see stefania fusco, the patentability of financial methods: the market participants’ perspectives, 45 loy. l.a. l. rev. 1 (2011), https://ssrn.com/abstract=1800853. (discussing the patent and innovation in the financial industry with data analytics compiled through market surveys and interviews.) see also ted hagelin, a new method to value intellectual property, 30 aipla q. j. 353, 362 (2002). https://ssrn.com/abstract=1800853 https://www.researchgate.net/publication/252398618_the_option_value_of_patent_licenses http://users.ox.ac.uk/~mast0140/ejwp0599.pdf http://scholarship.law.unc.edu/nclr/vol95/iss5/4 https://arxiv.org/abs/1905.02666 indiana health law review [vol. 21:277 302 option price. 190 as such, for thyroid patents, options pricing may be valuable due to the need for narrow and specialized skillsets in drafting. options pricing models also account for costs, 191 profits,192 and royalties. 193 for example, the option price in a licensing contract for a new treatment to hyperthyroidism would include the licensee’s initial fee to acquire the right to develop, future payments resulting from market exclusivity, and the cost to commercialize the underlying technology.194 patent valuation methods are a starting point towards better ip strategy. 195 this paper seeks to advance the literature toward a concrete framework for thyroid patent valuation by defining patent value metrics with reference to the state-of-the-art. one problem that persists is how to use this information to make better patent strategy decisions. integrating factors correlating with patent value with an expert system provides a solution formalizing the decision process. moreover, the value of new thyroid inventions, and their associate patents are largely tied to the progress through clinical trials made by the inventor. b. fda trials clinical trials are prospective, organized, systematic exposures of patients to an intervention of some kind. 196 despite widespread fraud and corruption, the united states food and drug administration has evolved as one of the world’s ————————————————————————————— 190. united states patent and trademark office, uspto fee schedule (2020), https://www.uspto.gov/learning-and-resources/fees-and-payment/uspto-fee-schedule. see also leahy-smith america invents act of 2011, pub. l. no. 112-29, 125 stat. 284-341. (see section 11 fees for patent services, which de facto prevents inventors living in poverty from being able to patent or protect their inventions.) 191. cotropia, supra note 186, at 1135. 192. leone & oriani, supra note 188, at 5 (and, the net present value for a patent license is subject to volatility stemming from different sources of uncertainty. thus, licensing contracts provide the licensee with the opportunity to acquire the cash flows from the commercialization of the patented technology.). 193. andrew chin, supra note 184, at 1438. (most research focuses on the black-scholesmerton model for options pricing. the black-scholes-merton model is based on simplifying assumptions about the statistical movement of stock prices and market efficiency). [https://perma.cc/2pnb-9ukv] 194. leone & oriana, supra note 188, at 5. 195. robert pitkethly, the value of patents, wp 21/97 judge institute working paper 1, 1 (1997), https://users.ox.ac.uk/~mast0140/ejwp0599.pdf. [https://perma.cc/h4wl-bjwe] see also fusco, supra note 189, at 4. (discussing the patent and innovation in the financial industry with data analytics compiled through market surveys and interviews.) see also stefania fusco, et al., monetization strategies of university patents through paes: an analysis of us patent transfers, issi conference proceedings (forthcoming 2019), https://papers.ssrn.com/sol3/ papers.cfm?abstract_id=3410086. [https://perma.cc/9sjr-xafl] 196. suzanne white junod, fda and clinical drug trials: a short history, fda 1. 1 (2008), https://www.fda.gov/media/110437/download [https://perma.cc/677n-68rk] (based largely on observations and tested through time by trial and error, ancient medicine such as that practiced by the egyptians, babylonians, and hebrews was closely allied with religion). https://perma.cc/677n-68rk https://www.fda.gov/media/110437/download https://perma.cc/9sjr-xafl https://papers.ssrn.com/sol3 https://perma.cc/h4wl-bjwe https://users.ox.ac.uk/~mast0140/ejwp0599.pdf https://perma.cc/2pnb-9ukv https://www.uspto.gov/learning-and-resources/fees-and-payment/uspto-fee-schedule 2024] inventions and patents for treating 303 thyroid disease institutional authorities for conducting and evaluating controlled clinical drug trials. 197 significant statutory barriers stifle the process by which new drugs and biotechnologies migrate to market. as a result, the public loses out on medical advancements and inventions, which would otherwise save lives and improve the public quality of life. the fda plays an essential role in the process by which new drugs and biotechnologies come to market. 198 however, more essential is that the public and private interests are aligned through a transparent, lucid, and accessible incentive structure embedded in the regulatory climate. there are many interests at play in designing incentives to promote and foster innovation and progress. 199 as such, structuring incentives for firms, the public, and the fda is crucial to creating an optimal regulatory framework. to bring any new drug or device relating to the human thyroid to market you need to get fda clearance. the fda approval path depends on the risk of the device. in some circumstances, a device may be able to be fast tracked to approval if there is a predicate device. for the predicate device to be successful, the device needs to be very similar. there will be a comparison of both mechanics and disease for which the device is manufactured. devices are regulated by algorithm and there is guidance around software as a medical device. another issue that may arrive relates to software as a medical device. 200 for purposes of fda trials there are three categories of medical devices. 201 the first category is category 1, which requires full clinical trials and poses the most severe risk to life. the second category is category 2, which includes an accelerated approval path and has milder risk and lacks any potentially lethal risk. the third category is category 3, where devices carry the least risk and require no clinical trials for approval. still there may be better opportunities for innovation outside the united states where there exits great opportunity to solve real problems relating to thyroid disease. c. innovation there is opportunity for innovation relating to thyroid disease. in fact, ————————————————————————————— 197. id. 198. patricia j. zettler, et al., implementing a public health perspective in fda drug regulation, 73 food & drug law j., 221, 222 (2018). (“fda, through its authority over the drug market, undoubtedly has an important role to play in this landscape.”) see also junod, supra note 196, at 1 (“the fda is a prominent institutional authority for conducting and evaluating clinical drug trials.”). 199. see: fda new drug approval, constitutional rights, and the public’s health, 37 j. of law, med. & ethics 2, 7 (2009). 200. software as a medical device (samd), fda(dec. 04,2018), https://www.fda.gov/ medical-devices/digital-health-center-excellence/software-medical-device-samd. [https://perma. cc/9h5y-yy2e] 201. how to find and effectively use predicate devices, fda, (sept. 4, 2018), https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectivelyuse-predicate-devices. [https://perma.cc/9uts-lxce] https://perma.cc/9uts-lxce https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectively https://perma https://www.fda.gov indiana health law review [vol. 21:277 304 treatments for thyroid disease have not improved in over five decades since screening for hypothyroidism using antibodies was originally first introduced. 202 inventing is the only way to innovate; it’s a process by which problems are solved anew. inventions are new and useful machines or processes. 203 inventing new drugs and biotechnologies for solving problems and curing conditions relating to thyroid disease is easy. the hard part, bringing inventions to life, is an extremely long, meticulous, and daunting challenge. it’s important to study history to move forward. generally, inventions are as good as the history they erase. for inventions relating to thyroid disease, it’s possible to overwrite roughly fifty years of history because treatments have not changed much since.204 according to dr. elizabeth mcanich, the world’s leading expert on thyroid disease and a current professor at stanford medical school, “two major developments in the 1970s led to a transition in clinical practice: 1) the development of the serum tsh radioimmunoassay led to the discovery that many patients were overtreated, resulting in a dramatic reduction in thyroid hormone replacement dosage, and 2) the identification of peripheral deiodinase-mediated t4-to-t3 conversion provided a physiologic means to justify l-thyroxine monotherapy.”205 an important evolution for the future of thyroid hormone treatment will likely be the use of combination therapy. indeed, providing new mechanisms for the treatment of thyroid that more closely model the biological synthesis of thyroid hormone offer the opportunity for improved treatment options and maintaining patient metabolic homeostasis. 206 still patients are only treated with lt4. but a common problem with symptom-based diagnostics is that there is no method for identifying the root cause of symptoms and therefore, it is likely that many peripheral problems relating to unstable metabolic control stemming from thyroid disease go unnoticed. the secret to inventing any new cure or treatment has three steps. first, write down the problem. second, study and think about the problem. third, write down the solution in patentable form. thus, the process for inventing new treatments for thyroid disease is relatively straightforward, insofar as the process simply requires the identification of existing problems, which are abundant, and the focus to generate a solution. however, large institutional barriers still loom to slow innovation and progress more generally. ————————————————————————————— 202. elizabeth a. mcaninch, and antonio c. bianco, the history and future of treatment of hypothyroidism, 164 annals internal med. 50, 82 (2016) 203. 35 u.s.c. § 101. 204. mcaninch, supra note 202, at 80. . 205. id. at 50. 206. gomes-lima, supra note 108, at 3. 2024] inventions and patents for treating 305 thyroid disease iv. conclusion this paper proceeds in three parts. part i explored thyroid disease, including diagnostics, hypothyroidism, and hyperthyroidism. part ii empirically investigated inventions for treatments to thyroid disease through the lens of the patent system. part iii consolidated considerations for commercialization of inventions for treating thyroid disease. as evolution 207 continues, the future will likely be defined by human-machine symbiosis. in turn, the process of integration with the next generation of humans will likely lead to a complete cure for human thyroid disease, it’s only a matter of time. in the words of jonas sulk, “there is hope in dreams, imagination, and in the courage of those who wish to make those dreams a reality.” ————————————————————————————— 207. charles darwin, on the origin of species by means of natural selection, or the preservation of favored races in the struggle for life 14 (london, john murray 1859). (when we look to the individuals of the same variety of our ancestors, one of the most striking points is they generally differ much more from each other, than do the individuals of any one species or variety in a state of nature.) indiana health law review [vol. 21:277 306 v. appendices appendix a. hypothalamic-pituitary-thyroid axis model 2024] inventions and patents for treating 307 thyroid disease appendix b. hypothalamic-pituitary-thyroid axis description indiana health law review [vol. 21:277 308 appendix c. levothyroxine tablet information 2024] inventions and patents for treating 309 thyroid disease appendix d. symptoms for thyroid disease hypothyroidism208 hyperthyroidism209 1. weight gain. 2. depression. 3. slow movements and thoughts. 4. muscle aches and weakness. 5. muscle cramps. 6. dry and scaly skin. 7. brittle hair and nails. 8. loss of libido. 9. pain, numbness, and a tingling sensation. 10. tiredness. 11. more sensitivity to cold. 12. constipation. 13. dry skin. 14. puffy face. 15. hoarse voice. 16. coarse hair and skin. 17. muscle weakness. 18. muscle aches, tenderness, and stiffness. 19. unusually heavy menstrual cycles. 20. thinning hair. 21. slowed heart rate, also called bradycardia. 22. depression. 23. memory problems. 24. feeding problems. 25. poor growth. 26. poor weight gain. 27. jaundice. 1. losing weight without trying. 2. tachycardia. 3. arrhythmia. 4. pounding of the heart, sometimes called heart palpitations. 5. increased hunger. 6. nervousness, anxiety, and irritability. 7. tremor. 8. sweating. 9. changes in menstrual cycles. 10. increased sensitivity to heat. 11. changes in bowel patterns. 12. swelling at the base of the neck. 13. tiredness. 14. muscle weakness. 15. sleep problems. 16. warm, moist skin. 17. thinning skin. 18. fine, brittle hair. 19. nervousness, anxiety, and irritability 20. hyperactivity. 21. mood swings 22. difficulty sleeping 23. feeling tired all the time 24. sensitivity to heat. ————————————————————————————— 208. nhs, symptoms-underactive thyroid (hypothyroidism) (2022), https://www.nhs.uk/conditions/underactive-thyroid-hypothyroidism/symptoms/. see also mayo clinic, hypothyroidism (underactive thyroid) (2022), https://www.mayoclinic.org/diseasesconditions/hypothyroidism/symptoms-causes/syc-20350284. 209. may clinic, hyperthyroidism (overactive thyroid) (2022). see also symptomsoveractive thyroid (hyperthyroidism) (2022), https://www.nhs.uk/conditions/overactive-thyroidhyperthyroidism/symptoms/. https://www.nhs.uk/conditions/overactive-thyroid https://www.mayoclinic.org/diseases https://www.nhs.uk/conditions/underactive-thyroid-hypothyroidism/symptoms indiana health law review [vol. 21:277 310 28. constipation. 29. poor muscle tone. 30. dry skin. 31. hoarse crying. 32. enlarged tongue. 33. umbilical hernia. 34. poor growth that leads to short stature. 35. delayed development of permanent teeth. 36. delayed puberty. 37. poor mental development. 25. muscle weakness 26. diarrhea. 27. needing to pee more than usual. 28. persistent thirst. 29. itchiness. 30. loss of interest in sex. structure bookmarks inventions and patents for treating spreading a digital disease: the circuit split on data breaches and its effects on the health sector nicole b. perkins* i. introduction in the last decade, hackers stole personal information from millions of americans. a pew survey found that 64 percent of americans “have personally experienced a major data breach.”1 a data breach means that there is a loss, theft, or unauthorized access to someone’s confidential personal information contained in electronic data.2 state laws often describe data breach notification requirements, and these laws differ from state to state.3 there is no singular body of law that regulates the security of private personal information at the federal level, and it is instead sector specific.4 the typical data breach begins with customers, clients, or patients handing over sensitive information to an organization or corporation they trust.5 this sensitive information can include a broad spectrum of data, including social security numbers, bank account information, home addresses, trade secrets, and even matters of national security.6 the attacker will pick a target that he perceives to be “weak” or not secure. the attacker typically will either use a network-based attack where he hijacks the network the organization uses, or he will use a social attack which could include phishing tactics.7 a. the issue: data breaches and the health sector the health industry experiences more data breaches than any other sector, typically because of medical identity theft.8 the healthcare field provides a * j.d. candidate, 2023, indiana university robert h. mckinney school of law; b.a., 2020, university of dayton. 1. kenneth olmstead & aaron smith, americans and cybersecurity, pew rsch. ctr. (jan. 26, 2017), https://www.pewinternet.org/2017/01/26/americans-and-cybersecurity/ [https://perma. cc/g9u2-vw9c]. 2. andrew froelich et al., data breach, tech target (july 2022), https://searchsecurity. techtarget.com/definition/data-breach [https://perma.cc/j36u-y7kc]. 3. security breach notification laws, nat’l conf. of state leg. (jan. 17, 2022), https://www.ncsl.org/research/telecommunications-and-information-technology/security-breachnotification-laws.aspx [https://perma.cc/wj7p-8xqh]. 4. id. 5. data breach, trendmicro, https://www.trendmicro.com/vinfo/us/security/definition/ data-breach [https://perma.cc/6lwx-dh3h] (last visited oct. 16, 2021). 6. id. 7. id. 8. data breaches in the healthcare sector, ctr. internet sec., https://www.cisecurity. org/blog/data-breaches-in-the-healthcare-sector/ [https://perma.cc/jj7z-xu9r] (last visited oct. 16, 2021). 436 indiana health law review [vol. 20:435 unique opportunity for hackers to obtain deeply personal information about an individual that would not otherwise be shared with credit card companies, banks, or even their employer. for this reason, medical identity theft is on the rise as the fastest growing white collar crime in america.9 medical identity theft occurs when a hacker misuses the victim’s medical identity such as records, health insurance, or personal information to obtain medical care.10 the high numbers for data breaches in hospitals could also be due in part to the well-defined, legally mandated reporting requirements of the health insurance portability and accountability act (“hipaa”).11 in 2009, congress enacted the health information technology for economic and clinical health act (“hitech act”) which required the department of health and human services and federal trade commission to create notification requirements, so victims of data breaches would be alerted of a potential breach of their medical records.12 the data protection model set up by hipaa and the updates to notification requirements provided by hitech still did not entirely fix the issue of medical identity fraud. unlike financial identity theft victims, medical identity theft victims have very few private remedies available, which is problematic in how valuable medical information is for criminals.13 personal health information (“phi”) is more valuable on the black market than credit card credentials or regular personally identifiable information (“pii”).14 therefore, there is a higher incentive for cyber criminals to target medical databases.15 those breaches have resulted in the loss, theft, exposure, or impermissible disclosure of 268,189,693 healthcare records,16 which equates to more than 81.72 percent of the population of the united states.17 in 2018, healthcare data breaches of 500 or more records were being reported at a rate of around one per day.18 in december 2020, that rate had doubled. the average number of medical breaches per day for 2020 was 1.76.19 those who feel threatened by their phi in the hands of hackers and criminals have often turned to their state laws for potential legal recourse. because state 9. medical identity theft on the rise, providertrust (oct. 5, 2017), https://www. providertrust.com/blog/medical-identity-theft-rise/ [https://perma.cc/ngn3-2ysa]. 10. pam dixon, medical identity theft: the information crime that can kill you, world priv. f. 1, 7 (2006), https://www.worldprivacyforum.org/2006/05/report-medical-identity-theft-theinformation-crime-that-can-kill-you/ [https://perma.cc/7dap-lzp3]. 11. data breaches in the healthcare sector, supra note 8. 12. howard burde, the hitech act: an overview, 13 am. med. ass’n j. ethics 172, 183 (2011). 13. dixon, supra note 10. 14. data breaches in the healthcare sector, supra note 8. 15. id. 16. healthcare data breach statistics, hipaa j., https://www.hipaajournal.com/healthcaredata-breach-statistics/ [https://perma.cc/3nxg-4eq5] (last visited oct. 16, 2021). 17. id. 18. id. 19. id. 2023] spreading a digital disease 437 laws drastically differ depending on which state the breach occurred, the results for victims of data breaches have proven to be inconsistent. for example, the supreme court of new york granted a motion to dismiss for failure to state a claim when plaintiffs attempted to sue north shore long island jewish health systems when their phi was stolen.20 the supreme court granted the motion to dismiss because an increased risk of future identity theft does not satisfy the injury-in-fact requirements for standing. in other states that have similar statutory language, the result has been different. the supreme court of georgia held that patients alleged a legally cognizable injury for negligence claim when there was a data breach by a hacker known as “dark overlord.”21 in that case, the court stated “presumably, the purpose of the hack is, sooner or later, to make fraudulent charges or assume those consumers’ identities.”22 the court went on to state that for this reason, the plaintiffs’ claim should not have been dismissed for failure to allege a cognizable injury because the risk of a patient’s misuse of his or her phi is “imminent and substantial.”23 reports have indicated that victims of health care fraud and medical identity theft increasingly wish to pursue legal action. in 2018, “5.7% of data breaches publicly reported led to class action litigation . . . indicating a steady increase in class action litigation relative to the number of breaches.”24 many plaintiffs turn to the federal system, only to run into similar roadblocks. b. roadmap this note first discusses in section ii the constitutional standard for standing, followed by the current supreme court precedent cases which clarify the standards for article iii standing, clapper v. amnesty international and spokeo, inc. v. robins. section iii then discusses how the circuit courts have interpreted these cases and the divide among the circuits. section iv narrows in on the healthcare circuit split, focusing on the third and d.c. circuits’ cases, attius v. carefirst and beck v. mcdonald. section v discusses the implications of such a circuit split and the potential dangers it may cause within the healthcare sector. section vi rejects a common solution to the data breach standing issue, which is a proposition for federal legislation and cites the recently decided transunion v. ramirez supreme court case. section vii proposes a different solution, which is that the supreme court should create a narrow ruling about data breaches and standing and should first hear a case in the healthcare field. in the healthcare setting, plaintiffs should be able to have standing for potential future harms. 20. abdale v. n. shore long island jewish health sys., inc., 19 n.y.s.3d 850, 860 (n.y. sup. ct. 2015). 21. collins v. athens orthopedic clinic, p.a., 837 s.e.2d 310, 311 (ga. 2019). 22. id. at 315. 23. id. at 316. 24. david zetoony et al., data breach litigation report, brian cave leighton paisner l. 1, 2 (2019), https://www.bclplaw.com/images/content/1/6/v6/163774/2019-litigation-report.pdf [https://perma.cc/p4qt-gnnc]. 438 indiana health law review [vol. 20:435 this note concludes with a warning that a blanket ruling on standing for data breaches could be potentially dangerous to small businesses who did not foresee litigation costs. this note advocates for a narrowly tailored ruling to the healthcare sector which implements a balancing test. this balancing test would weigh the fact that the healthcare sector has suffered some of the largest security breaches in the country, while also considering that hospitals and healthcare facilities may follow up-to-date data breach protections. additionally, this note advocates for a narrow ruling tailored to the health care industry because it will also help frame the issue for future judicial decisions in other areas outside of the healthcare sector. ii. turning to precedent although the supreme court has not addressed a data breach case specifically, the individual justices have debated for years about the constitutional interpretation of standing and when plaintiffs should be able to get past the pleading stage. a. constitutional foundation and early case law standing is the initial determination of whether or not a person who believes he or she has been wronged has grounds to sue based on the contextual understanding of article iii of the united states constitution.25 article iii, which governs federal courts, places a limit on the judiciary and dictates that federal courts can only hear “cases” and “controversies” that are “traditionally amenable to, and resolved by, the judicial process.”26 the supreme court in lujan v. defenders of wildlife decided that to sue in federal court, a plaintiff must establish an injury-in-fact to show an invasion of their protected interest; that is (a) concrete and particularized and (b) actual or imminent.27 in lujan, the case centered around the endangered species act (esa), which seeks to protect animals against threats to their continuing existence caused by man.28 section 7(a)(2) of the esa requires each federal agency to consult with the united states secretary of the interior to ensure that any action authorized, funded, or carried out by the agency in question is not likely to jeopardize the continued existence of any endangered or threatened species of animals.29 the esa also states that any person can begin a civil suit on her own behalf to enjoin anyone, including governmental agencies from violating 25. lujan v. defs. of wildlife, 504 u.s. 555, 560 (1992) (citing allen v. wright, 468 u.s. 737, 751 (1984)) (“[t]he core component of standing is an essential and unchanging part of the case-or-controversy requirement of article iii.”). 26. steel co. v. citizens for a better env’t, 523 u.s. 83, 102 (1998). 27. lujan, 504 u.s. at 555. 28. standing under the supreme court’s landmark luhan v. defenders of wildlife decision, con. law rep. (2018), https://constitutionallawreporter.com/2020/02/25/lujan-v-defenders-ofwildlife-decision/ [https://perma.cc/hue2-jzw2]. 29. lujan, 504 u.s. at 558. 2023] spreading a digital disease 439 the esa.30 in 1978, the secretaries promulgated a joint regulation stating that the esa section 7(a)(2) requirement will extend to federal actions in foreign countries.31 however, in 1986, the regulation limited the geographic scope to the united states and the high seas.32 organizations dedicated to the protection of endangered animals and wildlife generally sued the secretary of the interior, lujan, seeking a declaratory judgment that the new regulation is incorrect, and requested an injunction requiring the secretary to restore the initial interpretation of the geographic scope.33 the plaintiffs argued they were injured because a lack of consultation for governmental activities abroad increases the rate of extinction.34 the secretary moved to dismiss based on lack of standing.35 the court held that a plaintiff may not litigate a generalized complaint against the government based on harm suffered equally by all citizens.36 the court famously stated, “an injury in fact is an invasion of a legally protected interest which is (a) concrete and particularized . . . and; (b) actual or imminent.”37 the court also notably stated that the injury must be fairly traceable to the challenged action and not the result of the independent action of some third party.38 lujan is still considered the touchstone case for analyzing article iii standing. the subsequent supreme court opinions surrounding article iii standing attempt to clarify when plaintiffs have standing for future harms, which was not squarely addressed in lujan. b. clapper’s “substantial risk” and “certainly impending” standards clapper v. amnesty international usa expanded upon the actual and imminent harm element of standing.39 the plaintiffs in clapper challenged 50 u.s.c. §1881a, an amendment of a provision of foreign intelligence surveillance court amendments act of 2008 (“fisa”), which authorized the united states government to conduct surveillance without probable cause on non-u.s. citizens who were outside the united states. under this amendment, the government would be able to conduct surveillance without the usual requirements to obtain permission from the court to intercept communications.40 by shrinking the requirements under fisa, the government only needed to demonstrate that the surveillance they seek to intercept targets “persons reasonably believed to be located outside the united states” and seeks to “acquire foreign intelligence 30. id. at 572. 31. id. 32. id. at 560. 33. id. 34. id. 35. id. 36. id. at 551. 37. id. 38. id. at 552. 39. clapper v. amnesty int’l usa, 568 u.s. 398, 409 (2013). 40. id. at 404. 440 indiana health law review [vol. 20:435 information.”41 the plaintiffs in this case were attorneys and human rights, labor, legal, and media organizations whose work allegedly required them to engage in confidential, and sometimes privileged communications with colleagues, clients, sources, and other individuals who are located outside of the united states.42 the plaintiffs brought suit seeking a declaratory ruling that this portion of fisa was unconstitutional.43 the plaintiffs claimed there was an “objectively reasonable likelihood” of injury that the plaintiffs’ communications would be recorded under fisa. alternatively, the plaintiffs claimed that given the risk of surveillance, they had a present injury because such risk required them to spend significant funds to ensure that their communications were kept confidential.44 the court ruled that the plaintiffs did not have standing.45 justice alito, writing for the majority, articulated the “certainly impending” standard, stating that the plaintiffs’ “speculative chain of possibilities does not establish that injury based on potential future surveillance is certainly impeding or is fairly traceable to fisa.”46 the case was dismissed because an injury for standing purposes must be “certainly impending,” and because the plaintiffs could not satisfy the constitutional requirement to bring suit. however, in a footnote of the opinion, the court stated that plaintiffs do not need to uniformly prove that it is “literally certain that the harms they identify will come about.47 in some instances, the court admitted they have found standing based on a “substantial risk” that the harm will occur, which may prompt plaintiffs to reasonably incur costs to mitigate or avoid that harm.”48 the court then goes onto say that the plaintiffs in this case missed the mark on both the “substantial risk” standard and the “clearly impending” requirement in light of the “attenuated chain of inferences necessary to find harm here.”49 justice alito then addressed the plaintiff’s alternative argument, that they established standing on the measures they have taken to avoid fisa surveillance. he states, “respondents cannot manufacture standing merely by inflicting harm on themselves based on their fears of hypothetical future harm that is not certainly impending.”50 while clapper is factually unrelated to a data breach, clapper has proven to be the touchstone case used by corporations when victims allege harm from a breach of their information due to a hacking of the corporation’s systems. in many ways, clapper has “tightened” the standing test, making it more difficult for plaintiffs to litigate their issues in court. 41. id. at 404-05. 42. id. at 409. 43. id. 44. id. at 406-507. 45. id. at 414. 46. id. 47. id. at 414-15 n.5. 48. id. 49. id. 50. id. at 416. 2023] spreading a digital disease 441 in clapper’s dissent, justice breyer took issue with the “certainly impeding” standard, perhaps predicting that entities sued for failing to protect consumer data would assert this as a defense. he stated that plaintiffs will struggle to make the connection between the danger they believe they are in, like a breach of information, with a certainly impending harm.51 he states “[t]he word ‘certainly’ in the phrase ‘certainly impending’ does not refer to absolute certainty. as our case law demonstrates, what the constitution requires is something more akin to ‘reasonable probability’ or ‘high probability.’52 according to justice breyer, the plaintiffs’ claims here were not based on “attenuated chain of inferences” but rather on facts providing that interception was highly likely.53 the plaintiffs here reasoned that the government’s past behavior demonstrated an interest in seeking the information that the plaintiffs would engage in. the allegations were not based on an unreasonable fear but on facts proving that interception was likely.54 c. spokeo and further confusion with “concrete injury” standard the decision in clapper caused much confusion among the circuit courts. as a result of this confusion, the supreme court heard spokeo, inc. v. robins, an appeal out of the ninth circuit. the plaintiff, robins, filed a class action lawsuit against spokeo alleging that information pulled on him through spokeo search engine was inaccurate, thus, violating the fair credit reporting act’s procedures for requiring accuracy as a reporting agency.55 spokeo provides personal information about individuals to a variety of users, including employers researching potential employees.56 spokeo collects information on individuals from a multitude of databases. this information includes phone numbers, addresses, marital status, age, occupation, shopping preferences, and even musical preferences.57 robins asserted that his spokeo profile caused him to suffer actual harm to his employment, because the inaccurate reporting of his alleged graduate degree and children made him seem overqualified and unlikely to relocate because of family obligations.58 the court re-examined the injury in fact requirement of standing and found that the injury suffered must be “concrete and particularized.”59 the court held that , the plaintiff only alleged an intangible harm, which was not concrete nor particularized, thus, the plaintiff had no standing.60 the court reasoned that although there was a violation of a procedural right granted by a statute, the 51. id. at 441. 52. id. 53. id. 54. id. at 444. 55. spokeo, inc. v. robbins, 578 u.s. 330, 334 (2016). 56. id. 57. id. 58. id. 59. id. 60. id. at 1544. 442 indiana health law review [vol. 20:435 plaintiff cannot satisfy the demands of article iii by alleging a bare procedural violation. the plaintiff experienced no “concrete harm.”61 the court did not take this opportunity to define what constitutes a “concrete” injury, nor did it declare whether a risk of future harm was enough to constitute an injury-in-fact, for purposes of establishing article iii standing, specifically the element of imminence. the court stated that although an abstract injury is not a concrete one, an intangible injury can be sufficient, if it is fairly traceable to the defendant’s actions and the court can redress the injury.62 although the court did not explicitly identify whether an increased risk of future harm is enough to satisfy the element of imminence, it stated that a statutory right created by congress cannot automatically give an individual the right to sue.63 the violation of a statutory right must be combined with a concrete injury. unfortunately, spokeo did nothing to resolve the circuit split resulting from clapper. the spokeo decision did not address the question of whether a data breach without any financial loss constitutes a concrete injury for article iii standing. circuits remain split on whether the risk of future harm is sufficient to establish article iii standing, and now they are wrestling with exactly how spokeo applies to allegations of an increased risk of identity theft following a data breach. iii. the circuit split regarding data breaches federal circuits over the past few years have wrestled with clapper and spokeo interpretations, and the question of whether plaintiffs in a data breach class action can establish standing, if they only allege a heightened “risk of future harm” still lingers. the third, sixth, seventh, ninth, and d.c. circuits have generally found standing, while the first, second, fourth, fifth, and eighth circuits have generally found no standing where plaintiff only alleges a heightened “risk of future harm.”64 the third and d.c. circuits addressed that question specifically within the healthcare sector and found standing, where the fourth and fifth circuits addressed the same question within the healthcare sector and found no standing.65 the arguments on either side are driven by considerations for businesses, policy, and what constitutes standing. a. plaintiffs have standing due to the unclear standing standard set out in clapper and reinforced in 61. id. at 1550. 62. id. at 1547. 63. id. 64. jason c. gavejian & maya atrakchi, the circuit split continues: 11th circuit weighs in on standing in data breach litigation, jackson lewis (mar. 23, 2021), https://www.workplace privacyreport.com/2021/03/articles/data-breach-notification/the-circuit-split-continues-11th-circuitweighs-in-on-standing-in-data-breach-litigation/ [https://perma.cc/v4at-rhft]. 65. id. 2023] spreading a digital disease 443 spokeo, circuit courts have struggled to determine whether future harm from a data breach would be sufficient to establish a “concrete injury.” while the d.c., sixth, seventh, and ninth circuits have allowed these claims to move forward with an alleged risk of future injury, the second, third, fourth, and eighth circuits have not. the seventh, d.c., and sixth circuits have all found that, when personal information is stolen, plaintiffs have standing based on the risk of a future harm because, as stated by the d.c. circuit, “at the very least, it is plausible to infer that [the thief] has both the intent and the ability to use that data for ill.”66 additionally, because the facts of clapper did not involve a data security breach, these courts are much more inclined to extend standing to victims of data breaches because this risk was perhaps unforeseen by the justices in clapper. most courts concede that a financial harm or identity theft relating to a data breach is sufficient to satisfy the injury-in-fact component of standing.67 b. plaintiffs do not have standing some circuits do not recognize these types of “injuries” as sufficient to constitute standing. for example, in reilly v. ceridian corp.,68 the third circuit found that where allegations of a future injury required speculation, injury was not sufficiently imminent for the purposes of standing.69 reilly perhaps set an example to future cases in finding that the alleged increased risk of future injury was entirely speculative because it depended upon the future actions of a third party.70 additionally, the court held that there was no evidence that the intrusion was malicious.71 as for the healthcare industry, an important case which highlights a similar analysis as reilly, is beck v. mcdonald. in beck, the fourth circuit held that there was no injury where plaintiffs could not show that information contained on a stolen laptop was misused, or that the thief intended to misuse the information.72 the analysis consistent among the circuits that find future harm insufficient to establish standing is that article iii standing is a higher threshold to meet than merely showing an increased risk of harm subject to a data breach. iv. healthcare split because the healthcare sector experiences such a large percentage of the data breaches, focusing on the dc and fourth circuit’s approach to standing and data breaches displays the need for a healthcare-specific ruling from the supreme 66. attias v. carefirst, inc., 865 f.3d 620, 628 (d.c. cir. 2017). 67. see robert d. fram et al., standing in data breach cases: a review of recent trends, covington & burlington llp (nov. 9, 2015), http://www.bna.com/standing-data-breachn57982063308/ [https://perma.cc/yk29-uf6j]. 68. reilly v. ceridian corp., 664 f.3d 38, 39 (3d cir. 2011). 69. id. at 42-43. 70. id. at 45. 71. id. 72. beck v. mcdonald, 848 f.3d 262, 266 (4th cir. 2017). 444 indiana health law review [vol. 20:435 court. there are two specific cases with opposite holdings that deal with the healthcare sector which highlight this discrepancy: attius v. carefirst and beck v. mcdonald. a. attias’s pro-plaintiff approach to standing in attias v. carefirst, inc., carefirst and its subsidiaries are a group of health insurance companies who provide health insurance to approximately one million customers in the district of columbia, maryland, and virginia.73 when customers purchased carefirst’s insurance policies, they handed over information about themselves including their names, birthdates, email addresses, social security numbers, and credit card information.74 the companies stored this information on their servers. allegedly, carefirst failed to properly encrypt some of the data entrusted to its care.75 seven insureds subsequently filed a class action lawsuit against carefirst.76 the parties disagreed on whether the hackers were able to obtain the insureds’ social security numbers, and carefirst sought to dismiss the claims for lack of standing.77 the plaintiffs argued that they suffered an increased risk of identity theft as a result of the data breach, but the district court found this theory of injury to be too speculative.78 the d.c. circuit court relied on clapper, specifically footnote 5, to conclude that an “injury in fact” exists when there is a “substantial risk” that the injury will occur.79 the court distinguished the facts of attias from clapper by stating that unlike clapper, the alleged injuries were not comprised of many links in a casual chain.80 the court in attias stated that, in assuming all the allegations in the complaint were true (meaning social security numbers and credit card information were stolen), it was not too speculative to consider the plausible harms that plaintiffs could endure because, “at the very least, it is plausible to infer that [the thief] has both the intent and the ability to use that data for ill.”81 therefore, the plaintiffs had standing. the court referred to a 7th circuit decision, remijas v. neiman marcus grp., which held that it is plausible to infer that the individuals whose information was stolen had shown a substantial risk of harm from the data breach by allegations of future injury.82 therefore, the court held that the allegation could survive a motion to dismiss for failure to state a claim. the court in attias specifically quoted the 7th circuit in re-stating “why else would hackers break into a . . . database and steal consumers’ private information? presumably, 73. attias v. carefirst, inc., 865 f.3d 620, 622 (d.c. cir. 2017). 74. id. at 623. 75. id. 76. id. 77. id. at 622. 78. id. at 624. 79. id. at 626. 80. id. 81. id. at 627. 82. remijas v. neiman marcus grp., 794 f.3d 688, 693 (7th cir. 2015). 2023] spreading a digital disease 445 the purpose of the hack is . . . to make fraudulent charges or assume those consumers’ identities.”83 moreover, the court reasoned that the nature of the hack and the information stolen merited a finding that a “substantial risk” existed. the court in attias reasoned that the type of fraud that could occur that is unique to the healthcare industry. the court stated that the combination of members’ names, birth dates, email addresses, and subscriber id numbers alone qualifies as material theft when taken in conjunction with the heightened risk of medical identify theft.84 the court states that medical identity theft occurs when a “fraudster impersonates the victim and obtains medical services in her name.”85 that sort of fraud leads to “inaccurate entries in [victims’] medical records” and “can potentially cause victims to receive improper medical care, have their insurance depleted, become ineligible for health or life insurance, or become disqualified from some jobs.”86 the court says that these portions of the complaint “would make up, at the very least, a plausible allegation that plaintiffs face a substantial risk of identity fraud, even if their social security numbers were never exposed to the data thief.”87 this argument is important because the court identifies the unique harm that is associated with medical fraud. this decision by the d.c. circuit “amplifies the circuit split by strengthening the hand of potential class action litigants, and it may signal a potential turning of the tide on the issue of standing when the data breach involves intentional hacking.”88 b. beck and the hacker’s intent the fourth circuit did not find constitutional standing in beck v. mcdonald when a laptop with private information was stolen along with four boxes of pathology reports.89 the laptop and reports were stolen from william jennings bryan dorn veterans affairs medical center (“the vamc”) in columbus, south carolina.90 the stolen laptop contained unencrypted personal information of roughly 74,000 patients and the missing boxes held information for over 2,000 patients.91 the information stolen was very similar to the information that was compromised in attias, including names, birth dates, the last four digits of social security numbers, descriptive traits of patients, and medical diagnoses.92 the vamc’s own investigation concluded that the stolen 83. id. 84. attias, 865 f.3d at 627. 85. id. at 628. 86. id. 87. id. 88. edward r. mcnicholas & grady nye, d.c. circuit widens the split on standing in data breach cases after spokeo, sidley (aug. 8, 2017), https://datamatters.sidley.com/d-c-circuitwidens-split-standing-data-breach-cases-spokeo [https://perma.cc/nv39-b8zp]. 89. beck v. mcdonald, 848 f.3d 262, 266 (4th cir. 2017). 90. id. 91. id. at 267. 92. id. at 268. 446 indiana health law review [vol. 20:435 information resulted from vamc’s failure to follow proper procedures for maintaining personal information on encrypted computers.93 the vamc contacted its patients in accordance with south carolina data breach notification requirements, and at least seventeen additional data breaches ensued due to failure to properly implement procedures to secure information.94 richard beck and lakreishia jeffrey, veterans who received treatment at the vamc, filed a class action suit on behalf of the victims of the stolen personal information.95 the plaintiffs sought relief under the privacy act of 1974 for the threat of “current and future substantial harm from identity theft and other misuse of their [p]ersonal [i]nformation,”96 thus relying on clapper. the court found that the theft of unencrypted laptops and pathology reports were too speculative to confer standing without proof that the thief acted for the purpose of obtaining personal information.97 the court held that there was no proof that the thief stole the laptop with the purpose of obtaining the personal information.98 the court in beck determined that, in cases which found standing, the individual who stole personal information acted with the sole purpose of obtaining stolen personal information.99 the fourth circuit distinguished the facts in beck when it concluded that there was a deliberate targeting of personal information in other cases, and in doing so it relied upon factors. these factors included the sophistication of the hacking that took place, the lack of an alternative explanation for the hacking, and the fraudulent activity (such as identity theft and fraudulent charges) suffered by the plaintiffs.100 additionally, the court in beck emphasized that, because the plaintiffs’ stolen information was not used for fraudulent activity, from the time of the theft in 2014 to the time of the suit in 2017, there was no risk of “substantial harm.”101 while the hack in attias also occurred in 2014, the d.c. circuit reasoned that the stolen information still created a plausible “substantial risk” of harm, irrespective of the time that had passed without incident, such that the passage of time did not mitigate or negate the substantial risk.102 c. effect of the circuit split within the healthcare sector attias and beck demonstrate the divergence of analysis within the courts as to what constitutes a sufficient injury for victims of medical data breaches. the argument in beck, that the injury in fact is not certainly impeding, largely 93. id. at 276. 94. id. at 268. 95. id. at 267. 96. id. 97. id. at 273. 98. id. 99. id. 100. id. 101. id. at 275. 102. attias v. carefirst, inc., 865 f.3d 620, 628 (d.c. cir. 2017). 2023] spreading a digital disease 447 discounts the pertinent issue of stolen medical records in the hands of hackers or thieves. cybersecurity firm protenus, tracked 222 health care data hackings in 2018, and said that figure was up 25 percent since 2017.103 the ambiguity among the circuits and the lack of guidance from the supreme court is spreading a digital disease among medical patients in the united states. while patients suffer from physical ailments and put their trust in their doctors and insurers, they are also unknowingly subjecting themselves to another danger: fraud and extortion. v. future harms if the circuit split persists, the healthcare field will become confused and frustrated, and the patients affected by data breaches will face long-term repercussions. a. issues with medical records are difficult to resolve according to a federal trade commission consumer bulletin, medical identity theft is when someone uses your information to obtain a consultation with a doctor, purchase medical devices, submit false insurance claims, or obtain prescription drugs.104 gary cantrell, head of investigations at the united states department of health and human servicesoffice of inspector general said hackers tend to steal medical records because they are like “a treasure trove of all this information about you.” they contain a patient’s full name, address history, financial information, and social security number—which is enough information for hackers to take out a loan or set up a line of credit under patients’ names.105 the health care sector has relatively low security, so it is “easy” to get a large amount of data for medical fraud.106 to put the value of medical records into perspective, social security numbers sell on the dark web for prices as low as $1, credit card information sells for around $110, but experian reports full medical records sell for up to $1,000, and an entire database from a hospital in georgia sold for $26,000.107 103. what hackers actually do with your stolen medical records, advisory bd. (mar. 1, 2019, 10:00 am), https://www.advisory.com/daily-briefing/2019/03/01/hackers [https://perma.cc/hsy8-s22z]. 104. lisa tomaszewski, the dangers of medical identity theft, physician’s wkly. (oct. 13. 2021), https://www.physiciansweekly.com/the-dangers-of-medical-identity-theft [https://perma.cc/8rkd-k36b]. 105. hackers are stealing millions of medical records – and selling them on the dark web, cbs news (feb. 14, 2019, 7:37 am), https://www.cbsnews.com/video/hackers-are-stealingsensitive-medical-records-and-selling-them-on-dark-web/ [https://perma.cc/vy2v-7ym7]. 106. what hackers actually do with your stolen medical records, supra note 92. 107. hackers are stealing millions of medical records – and selling them on the dark web, supra note 106. 448 indiana health law review [vol. 20:435 b. credit report issues and other issues it is not always certain when the information will be used. hackers can keep the information for years before deciding to take action that would compromise the innocent party.108buyers of medical information might use the information to create fake ids to purchase medical equipment or drugs, or to file a false insurance claim.109 even after the hacker is caught, the hospital or insurance company that used this false information may still have the victim’s medical information in the hacker’s medical file.110 additionally, phi, such as information regarding a sexually transmitted disease or terminal illness, could be used to extort or coerce someone.111 many people have reported that they cannot get the charges “scrubbed” from the credit report until the next billing cycle, but by then the hacker would have already committed more medical fraud.112 there have also been cases of innocent people being arrested because someone has stolen their medical identity and used it to purchase an overabundance of prescription drugs in their name.113 in 2004, brandon reagin, a young marine, lost his wallet.114 months later, his mother called reagin stating that local authorities are looking for him because of multiple car thefts.115 upon looking into the matter, reagin realized someone was having multiple medical procedures under his name, and the bills added up to nearly $20,000.116 reagin attempted to dispute the charges on his credit report, but on the next billing cycle the charges appeared again.117 as of 2019, reagin still has not been able to undo all the damage caused by the hacker. the hospital that performed the procedures on the criminal still has the criminal’s blood type under reagin’s name, which resulted in health insurance issues, and confusion among healthcare professionals who have performed procedures on reagin himself.118 cybersecurity expert gary miliefsky, estimates it takes about “three seconds” to retrieve patient files off the dark web.119 108. id. 109. background on: insurance fraud, ins. info. inst., https://www.iii.org/article/ background-on-insurance-fraud [https://perma.cc/5bgt-af2m] (last updated feb. 15, 2022). 110. hackers are stealing millions of medical records – and selling them on the dark web, supra note 106. 111. id. 112. what hackers actually do with your stolen medical records, supra note 103. 113. tomaszewski, supra note 104. 114. hackers are stealing millions of medical records – and selling them on the dark web, supra note 103. 115. id. 116. id. 117. id. 118. id. 119. id. 2023] spreading a digital disease 449 vi. federal legislation is not the answer many observers and researchers of the circuit split advise for a piece of federal legislation that could potentially confer standing for victims of data breaches. this recommendation stems from a case decided by the third circuit, in re horizon healthcare services inc. data breach litigation. this case relied on the fair credit reporting act (“fcra”) to confer standing. however, in july 2021, the supreme court took issue with statutory standing for alleged future harms in the case transunion llc v. ramirez. a. horizon health care’s successful use of the fcra in 2017, the third circuit case in re horizon healthcare services inc. data breach litigation, was the result of two unencrypted laptops containing detailed personal information on approximately 839,000 clients were stolen from horizon’s headquarters.120 the information on these laptops contained personal information and health information of clients and potential clients.121 the named plaintiffs were among the members whose phi had been stolen, but they did not allege that their personal information had been viewed or used by the thieves or other third parties.122 in bringing the class action lawsuit, plaintiffs alleged, among other state claims, separate claims for willful and negligent violations of the fcra, maintaining that horizon was a consumer reporting agency under the act.123 the third circuit found standing for the plaintiffs under the fcra, which is a body of legislation that attempts to protect consumer privacy and imposes requirements on consumer reporting agencies.124 the third circuit clarified that this ruling did not contradict spokeo because the plaintiffs alleged more than a “mere technical or procedural violation,” but an “unauthorized dissemination of their own private information--the very injury that fcra is intended to prevent.”125 the horizon healthcare decision provided another potential avenue—a violation of a statutory right—for plaintiffs in class action data breach lawsuits to obtain standing.126 many have proposed that there should be federal 120. in re horizon healthcare servs. inc. data breach litig., 846 f.3d 625, 630 (3d cir. 2017). 121. id. 122. id. 123. id. at 631. see also robert a. stern, the state of article iii standing in the third circuit under horizon healthcare services, inc. data breach litigation and more, morrison mahoney (feb. 21, 2017), https://www.morrisonmahoney.com/blog/256-the-state-of-article-iii-standing-inthe-third-circuit-under-horizon-healthcare-services-inc-data-breach-litigation-and-more [https://perma.cc/q39u-6zgk]. 124. id. at 635. 125. id. at 640. 126. gregory n. blasé et al., third circuit moves toward a broader view of standing in fcra data-breach class action, k&l gates (jan. 30, 2017), http://www.klgates.com/thirdcircuit-moves-toward-a-broader-view-of-standing-in-fcra-data-breach-class-action-01-30-2017/ [https://perma.cc/x7b4-qewa]. 450 indiana health law review [vol. 20:435 cybersecurity legislation, but that would pose a new unique set of issues. b. the recent supreme court decision and what it means for plaintiffs alleging future harms under the fcra on june 25, 2021, the united states supreme court issued its decision in transunion v. ramirez, which will have rippling effects on the theory that plaintiffs can sue for a statutory violation when it comes to data breach litigation. in transunion, sergio ramirez acted as a representative for a class-action lawsuit against credit report agency transunion.127 ramirez alleged that transunion willfully violated the fcra by indicating on his credit report that his name appeared on a government list of individuals prohibited from conducting business in the u.s.128 ramirez had attempted to buy a car, but when the dealership ran a credit check, the credit report wrongfully indicated that ramirez was on a list of suspected terrorists with whom u.s. companies are barred from doing business.129 ramirez followed up with transunion, who had provided the credit report, and transunion sent ramirez two mailings indicating that his name was a “potential match” for two names on the terrorist watch list.130 ramirez claimed that those mailings did not comply with the fair credit reporting act.131 the class members in transunion fell into two groups: (1) those whose potential status as a national security threat was shared with third parties, and (2) those who were merely flagged in transunion’s internal records.132 a jury in the u.s. district court awarded over sixty-million dollars in damages to the class members.133 on appeal, the ninth circuit affirmed the district court’s judgment, but reduced the permember punitive damage amount.134 transunion argued that the case should not have been allowed to go forward as a class action because there was not a guarantee that each class member had suffered the same kind of injury required by the constitution to be able to file suit.135 transunion appealed to the supreme court of the united states.136 the supreme court held in transunion that consumer class action claims under the fcra must allege the actual spread of misleading information to third parties to establish standing to assert a claim.137 this decision supplements 127. transunion, llc v. ramirez, 141 s. ct. 2190, 2200 (2021). 128. id. at 2201. 129. id. see also amy howe, court limits standing in credit reporting lawsuit, scotusblog (jun 15, 2021, 1:58 pm), https://www.scotusblog.com/2021/06/court-limitsstanding-in-credit-reporting-lawsuit/ [https://perma.cc/8q4d-ju3b]. 130. id. at 2201-02. 131. id. at 2202. 132. id. 133. id. see also howe, supra note 116. 134. id. 135. id. see also howe, supra note 116. 136. id. 137. id. at 2201. 2023] spreading a digital disease 451 spokeo, which further restricts the circumstances where a statutory violation can form the basis of a claim.138 the majority opinion, written by justice kavanaugh, specifically rejected that the consumers in the class, whose information was not shared with third parties, had standing under the fcra to assert a claim based upon a risk of future harm.139 justice kavanaugh emphasized that the constitution requires plaintiffs suing in federal court to have a “personal stake” in the case. the court noted that, although congress’ views on what constitutes a concrete and particularized injury can be helpful, article iii is not satisfied merely because congress created a statutory cause of action.140 justice kavanaugh emphasized that “only those plaintiffs who have been concretely harmed by a defendant’s statutory violation may sue that private defendant over that violation in federal court.”141 absent analysis from the judiciary, congress could potentially create opportunities for far too many lawsuits, thus flooding the courts. transunion further indicates that a statutory violation, like the one found in horizon, will not be enough for future victims of healthcare data breaches to find legal recourse. c. why federal legislation does not work in the healthcare context conferring statutory standing for victims of healthcare fraud or medical identity theft is unlikely to provide plaintiffs with a way to hold the health sector accountable. as transunion demonstrates, article iii requirements are a “hard floor,” and congress may not circumvent them entirely.142 congressional legislation may authorize litigation by conferring standing within article iii’s confines. however, litigants are required to show “a distinct and palpable injury to [themselves]” that a court can remedy.143 congress may not direct federal courts to hear cases where article iii standing is not met. the fact that the third circuit found standing under the fcra, and then the supreme court denied standing on similar grounds, demonstrates the need not for more federal legislation, but rather interpretation from the judiciary. even further, “disagreements between republicans and democrats in congress have blocked proposed federal legislation addressing data breach issues.”144 even if there was federal legislation governing cybersecurity, it still would require a “collaboration between the legislature and the judiciary by requiring the judiciary to evaluate companies’ compliance with cybersecurity policies mandated by the legislation.”145 in other words, regardless of whether there is federal legislation 138. id. at 2204. 139. id. at 2212. 140. id. at 2204-05. 141. id. at 2212. 142. summers v. earth island inst., 555 u.s. 488, 497 (2009). 143. gladstone realtors v. vill. of bellwood, 441 u.s. 91, 100 (1979). 144. richard cowan & susan cornwell, republicans defend grip on u.s. congress as trump wins presidency, reuters (nov. 8, 2016, 6:13 am), http://www.reuters.com/article/us-usaelection-congress-iduskbn13317z [https://perma.cc/l9tt-edub]. 145. van ha le & bianca zamora, the price of a data breach, 4 info. sys. audit & 452 indiana health law review [vol. 20:435 or not, the supreme court would still need to guide the interpretation. vii. this note’s proposed solution this section of this note begins by advocating that the supreme court should take a data breach case involving a hospital or health insurance company because of the particularized harm the plaintiffs will likely have. this section then provides the reasons why there should not be a universal rule on data breach standing, and why hospitals are vulnerable targets. to understand why the supreme court should evaluate standing in the health sector, it is important to recognize the harm in creating a generalized rule for all data breaches. a. more particularized harm because medical identity theft is a particularized type of harm that could cause catastrophic damage, the future harm is more concrete and particularized, which would satisfy the standards set out in spokeo and clapper. victims of a healthcare data breach have potential harms that are “certainly impending.” the hipaa security rule establishes national standards to protect individuals’ electronic phi that is created, received, used, or maintained by a covered entity.146 the security rule requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.147 because there is no private right of action under hipaa, victims of a data breach in the healthcare sector have minimal opportunity for legal recourse.148 the fcra option of legal recourse has proven to be dependent on a circuit court’s interpretation of what is a mere procedural violation and what is a statutory violation, and the supreme court’s most recent decision in transunion furthers the need for guidance from the supreme court as to the difficulties in data breaches. b. safety precautions for hospitals and health insurers most breached healthcare organizations that securitymetrics, a payment card industry data security standard company, has investigated did not have an incident response plan at the time of the breach.149 a decision from the supreme control ass’n j. 1, 14 (2018). 146. summary of the hipaa security rule, u.s. dept. health & hum. serv., https://www. hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html [https://perma.cc/2yuwcudg] (last updated july 26, 2013). 147. id. 148. ryan knox, the ‘p’ is not for privacy: preventing private enforcement of hipaa, proc. n.y.u. moot ct. bo. (april 22, 2019), https://proceedings.nyumootcourt.org/2019/04/the-pis-not-for-privacy-preventing-private-enforcement-of-hipaa/ [https://perma.cc/dr63-hfa3]. 149. jen stone, how to manage a healthcare data breach, sec. metrics, https://www. securitymetrics.com/blog/how-manage-healthcare-data-breach [https://perma.cc/8gjq-tnvv] (last 2023] spreading a digital disease 453 court that would find standing for victims of a healthcare data breach would signal to hospitals that they should be taking the same precautions as large corporations in the business sector do. many state level privacy laws exist for businesses. in 2018, california adopted one of toughest privacy laws of any state with the consumer privacy act. it introduced new obligations for businesses to disclose information about data collection and protections for consumers that include a right to delete personal information and a right to opt out of having their information sold.150 c. universal rule on data breaches could hurt businesses given that it is typical for data breach class actions to involve tens of millions of plaintiffs, many corporations cannot withstand a financial blow of this magnitude.151 if a minimal showing of injury-in-fact sufficiently establishes standing, corporations, large and small, will face immense liability, considering the frequency and severity of data breach class actions. additionally, defendants in data breach class actions must notify affected consumers.152 with an average notification cost of five dollars per class member, the aggregate amount becomes financially crippling.153 the federal trade commission agrees that there is no such thing as perfect security and data breaches inevitably will happen.154 therefore, it is unreasonable to expect corporations to install an impenetrable fortress of data security.155 if courts allow a mere increased risk of identity theft to satisfy the injury requirement, attempts to establish an impenetrable system are incentivized due to the impending class action liability. for this reason, there needs to be specific interpretations of who can bring suit against corporations, and the healthcare sector is a good place to start because of the high level of privacy concerns and the specific information that could potentially be released. viii. potential holding of the u.s. supreme court the supreme court has had opportunities to address the “injury in fact” requirement of article iii standing, but failed to articulate a comprehensive standard that can be applied to future case law. this note advocates for a balancing test that the court can use as a tool to weigh the plaintiffs’ potential future injuries against the preparedness of the hospital. specifically, this visited oct. 16, 2021). 150. id. 151. ha le & zamora, supra note 145. 152. fed. r. civ. p. 23(c)(2). 153. ha le & zamora, supra note 145. 154. jared ho, corporate boards: don’t underestimate your role in data security oversight, fed. trade comm’n. (apr. 28, 2021, 9:29 am), https://www.ftc.gov/news-events/blogs/businessblog/2021/04/corporate-boards-dont-underestimate-your-role-data-security [https://perma.cc/e8595tvc]. 155. id. 454 indiana health law review [vol. 20:435 balancing test will examine the demonstrable probability of negative consequences of an individual’s phi in the wrong hands with reasonability of protections instituted to prevent disclosure. this balancing test will provide an opportunity for the hospital or healthcare facility to assert as a defense that they were also a victim of hacking and that they did everything that they could to prevent a data breach. the factors within this balancing test would focus first on the plaintiffs themselves and will look at (a) the significance of the information stolen, and (b) the time frame in which the complaint was filed. the next factor will then look at the hospitals and examine (c) the reasonableness of the hospital’s security maintenance. an overwhelming inclination toward one factor could outweigh a deficiency in another factor. a. the significance of the information stolen hipaa classifies all of a patient’s phi into eighteen different categories.156 this note advocates that for the first element of the balancing test the court will examine whether the stolen information falls into any of these categories. although this list is expansive and encompasses many kinds of data, hipaa clarifies that any data that (1) does not identify the patient, or (2) is used or disclosed by a covered entity during the course of care, is not considered phi.157 this distinction is important because using this standard, there are cases where phi may not have been leaked. in khan v. children’s national health system, there was no evidence that the information in the breach had been misused or had even been accessed.158 the hacker used phishing tactics to access the email accounts of certain employees at the hospital.159 the hacker did not hack the electronic medical records system or some other centralized database of personal data, so it was nearly impossible to tell what information the hacker had access to.160 the court found that the plaintiff, khan, lacked standing because the circumstances of the data breach did not clearly indicate that the hackers’ purpose was to use the patients’ personal data to engage in identity fraud.161 although this note agrees with the holding of khan, this note advocates that the hackers’ intent should not be the focus of the potential harm. to quote the seventh circuit in remijas,”why else would 156. abi tyas tunggal, what is protected health information (phi)?, upguard, https:// www.upguard.com/blog/protected-health-information-phi [https://perma.cc/v8x2-xldx] (last updated aug. 25, 2021). the hipaa categories are names, geographical identifiers smaller than a state, dates other than year related to a person, phone numbers, fax numbers, email addresses, social security numbers, medical record numbers, health plan beneficiary numbers, health plan beneficiary number, account numbers, license numbers, vehicle numbers, evidence identifiers, urls, ip addresses, finger prints, full facial photos, and any other unique identifying number. 157. id. 158. khan v. children’s nat’l health sys., 188 f. supp. 3d 524, 527 (d. md. 2016). 159. id. 160. id. 161. id. at 532. 2023] spreading a digital disease 455 hackers break into a . . . database and steal consumers’ private information? presumably, the purpose of the hack is . . . to make fraudulent charges or assume those consumers’ identities.”162 the intent of the hacker is less important than the significance that the information has on the plaintiff. in khan, the court could have considered the lack of significant data the hackers had access to and still reach the same conclusion that the plaintiffs lacked standing. by explicitly enumerating the type of data that is considered “significant,” this factor of the balancing test will clarify clapper’s “certainly impending” standard. in order to satisfy this factor, a plaintiff will have to identify a category that their stolen information falls under. if the plaintiff fails to do so, the harm cannot be said to be “certainly impending,” so this factor within the balancing test will not be met. this factor will also help the courts by eliminating a hacker’s intent, by assuming that if a hacker has access to these data points, the hacker is using this information for malicious purposes. additionally, there are certain categories of phi that hipaa identifies as more severe than others. for example, a hacker’s access to a social security number has more potential harm than merely having the patient’s name. the degree of confidentiality of the breached data will also contribute to the court’s analysis of this factor in determining whether a plaintiff has standing. b. timeliness of the complaint the next relevant factor in weighing whether plaintiffs have article iii standing for potential future harms is considering when the complaint was filed. this note adopts a point made by the fourth circuit in beck v. mcdonald, discussed above, which stated that “as the breaches fade further into the past, the plaintiffs’ threatened injuries become more and more speculative.”163 the timing of the complaint filed contributes to the clapper court’s “certainly impending” standard by considering the severity of the breach by accounting for when the complaint was filed.164 if a plaintiff waits a substantial amount of time to file suit after discovering there was a breach, a court is less likely to hold that there was a risk of “substantial harm.” the court in in re zappos considered the effect of lapsed time in a data breach suit.165 although not in the healthcare field, the court’s analysis regarding the timeliness of the complaint should be a relevant factor in determining whether victims of healthcare data breaches have standing. in zappos, hackers targeted zappos’ servers containing the personal identifying information of approximately twenty-four million customers.166 the following day, zappos sent an email to its customers notifying them of the breached server and stolen data.167 however, the 162. remijas v. neiman marcus grp., 794 f.3d 688, 693 (7th cir. 2015). 163. beck v. mcdonald, 848 f.3d 262, 275 (4th cir. 2017). 164. id. 165. in re zappos.com, 108 f. supp. 3d 949, 958 (d. nev. 2015). 166. id. at 951. 167. id. 456 indiana health law review [vol. 20:435 individuals harmed did not take immediate action in filing suit.168 the court held that the alleged threat of future harm cannot be considered certainly impending three and a half years after the breach occurred.169 during those three and a half years, the plaintiffs did not allege any theft or fraud.170 the court stated that “the more time that passes without the alleged future harm actually occurring undermines any argument that the threat of that harm is immediate, impending, or otherwise substantial.”171 the proposition that a court should consider the passage of time is not to say that the hospital or health care facility can wait to report the breach to affected patients. rather, this factor considers the promptness of the hospital reaching out to the patients and the turn-around of the patients filing suit upon receiving notice. if the hospital does not report the breach in a timely manner, the plaintiffs should not be penalized. in the same vein, if the hospital does notify the patients in a timely manner, the duty is on the patients to file suit quickly in order to meet the “substantial risk” standard. the hitech act requires that following a breach of unsecured phi, covered entities must provide notification to affected individuals, the secretary, and sometimes the media.172 covered entities must provide this individual notice in written form by first-class mail.173 alternatively, the covered entity may tell the patients by email if the affective individual had already agreed to receive such notices electronically.174 these individual notifications must be provided without unreasonable delay, and in no case later than sixty-days following the discovery of a breach.175 if a hospital meets these requirements, the duty is on the patient to promptly file suit. the court in zappos noted that the supreme court in clapper counseled against speculation, and the zappos court was thus apprehensive to consider the passage of time due to speculation.176 however, this note advocates that the passage of time is merely a consideration a court should consider and is not the definitive answer as to whether a harm is certainly impending. c. reasonableness of the hospital to maintain security the consideration of whether a plaintiff has article iii standing occurs early in the litigation process, that it may seem unorthodox to consider the actions of 168. id. 169. id. at 958. 170. id. at 957. 171. id. at 958. see also storm v. paytime, inc., 90 f. supp. 3d 359, 367 (m.d. pa. 2015) (“indeed, putting aside the legal standard for imminence, a layperson with a common-sense notion of ‘imminent’ would find this lapse of time, without any identity theft, to undermine the notion that identity theft would happen in the near future.”). 172. breach notification rule, 45 c.f.r. §§ 164.400-414 (2009). 173. id. 174. id. 175. id. 176. in re zappos.com, 108 f. supp. 3d 949, 958 (d. nev. 2015). 2023] spreading a digital disease 457 the defendant. however, when it comes to data breaches in hospitals and the sensitivity of the phi potentially stolen, this note advocates that there is a public policy argument for considering the actions of the hospital. a case that highlights the consideration of the defendants’ security measures is in re adobe systems. in adobe, hackers gained unauthorized access to adobe’s servers and spent several weeks inside adobe’s network without being detected.177 the hackers gained access to sensitive data of at least thirty-eight million consumers.178 following the data breach, researchers concluded that adobe’s security practices were deeply flawed and did not conform to industry standard.179 the court found that the plaintiffs plausibly alleged that they faced a substantial, ‘certainly impending’ risk of harm from the data breach because “the injury is fairly traceable to adobe’s failure to abide by its contractual obligation to provide reasonable security measures.”180 similarly, when a patient gives a hospital its phi, there is a contractual obligation by the hospital to provide reasonable security measures. many hospitals contend that increasing security measures is costly and still may not protect them. the center for internet security offers the malicious domain blocking and reporting (“mdbr”) service at no cost to all public and private hospitals and related healthcare organizations in the united states.181 mdbr provides an additional layer of cybersecurity protection and is a fully managed proactive domain security service.182 mdbr proactively blocks malware, is proven effective and easy to implement, does not interfere with business operations or patient care, and comes at no cost to the healthcare institution.183 this factor will also act as a defense for hospitals and health care organizations who have gone above and beyond to ensure their patients’ phi is protected. hospitals are the subject of data breaches because the healthcare system is vulnerable by design.184 most healthcare systems have different software packages and depend on different systems, emergency systems, x-ray software, pharmaceutical software, patient data and records management.185 the attack surface will continue to expand as more employees work from home and 177. in re adobe sys., inc. priv. litig., 66 f. supp. 3d 1197, 1206 (n.d. cal. 2014). 178. id. 179. id. 180. id. at 1220. 181. no-cost malicious domain blocking and reporting for u.s. hospitals, ctr. int. sec., https://www.cisecurity.org/hospitals [https://perma.cc/7pld-sugf] (last visited feb. 1, 2022). 182. id. 183. id. 184. heather landi, uhs breach shows the dangers facing hospitals with growing ransomware threats, fierce healthcare (oct. 2, 2020), https://www.fiercehealthcare.com/ tech/uhs-breach-shows-dangers-facing-hospitals-growing-cyber-threats [https://perma.cc/g47qwhhb]. 185. id. 458 indiana health law review [vol. 20:435 use network connections outside of the hospital itself.186 simple changes, such as two-factor authentication and utilizing unique passwords can help hospitals get ahead of data breaches.187 these three factors in the balancing test will better help courts discern the complicated topic of article iii standing for victims of data breaches of their phi. it is important to note that like all balancing tests, not all factors need to point in one direction to grant or dismiss a 12(b)(6) motion. an outstanding showing in one factor may outweigh a deficiency in another. however, in general, this note advocates that courts should err on the side of the plaintiff to better increase their chances of being heard before a court of law. as a matter of public policy, a hospital is in the best position to ameliorate the damage done by a data breach. bearing that the cost of litigation can be burdensome on a plaintiff, and increasing the plaintiff’s chances of being heard will help urge hospitals to be proactive in cyber security. ix. conclusion the ambiguity among the circuit courts when it comes to standing, data breaches, and healthcare is the most dangerous part of the supreme court’s lack of clarification in clapper and spokeo. although the topic of data breaches and their significant harms in the last decade is a relatively new threat to our country’s healthcare sector, the supreme court should not shy away from making a ruling on when plaintiffs can sue their healthcare providers or hospitals. perhaps the apprehension for the delay in supreme court precedent on the topic of article iii standing for healthcare data breaches is the tension between congress creating federal legislation and the judiciary creating law on the topic. in light of the recent transunion opinion, this note advocates that guidance from the judiciary would be more beneficial to society than more federal legislation. article iii standing is a “hard floor” that congress may not circumvent,188 which means that the question for victims is not “under what law can i bring suit?” but rather, “can i survive a motion for failure to state a claim?” risk of future harm may seem like an abstract harm to some but is a very real anxiety and danger to victims of data breaches. simultaneously, allowing plaintiffs to file suit for any kind of data breach could flood the courts and drive small businesses out of business. a balancing test, although unusual for the pleading stage of litigation, seems like a solution that considers the danger to victims while also considering the unfortunate position of the defendant. focusing the balancing test first on the healthcare sector will help the supreme court focus on one area of this relatively new harm instead of creating a blanket ruling. when a plaintiff has her phi stolen, files a timely complaint, and the hospital failed to have adequate security measures in place, the plaintiff should be able to survive a 12(b)(6) motion. 186. id. 187. id. 188. summers v. earth island inst., 555 u.s. 488, 497 (2009). 2023] spreading a digital disease 459 another scenario could be that a plaintiff cannot prove that her breached data falls into one of the categories of phi set out by hipaa, the plaintiff did not file a timely complaint, and the hospital had security measures in place such as mdbr. the point of this balancing test is that it synthesizes the precedent set out by the supreme court which indicates that the “certainly impending” and “substantial risk” standard is fact specific. the balancing test proposed by this note takes into account the multitude of ways a data breach can come about and helps weigh both the hospital and the patient’s interests. towards global harmonization: a comparative analysis of taiwan’s pharmaceutical track and trace system towards global harmonization: a comparative analysis of taiwan’s pharmaceutical track and trace system mark l. shope * abstract this article is a comparative study of the u.s. drug supply chain security act, the eu falsified medicines directive, and taiwan’s pharmaceutical track and trace system. this comparative approach will highlight the commonalities and differences in these various frameworks as they relate to pharmaceutical track and trace and assess how these systems can learn from each other. the article will provide a springboard for discussing an international framework for pharmaceutical track and trace, focusing on legal and operational interoperability. the core of the article will revolve around the need for national pharmaceutical track and trace systems to be interoperable with other national or regional systems. it will further emphasize how a collaborative international approach is necessary to ensure the full effectiveness of the pharmaceutical supply chain. this article will give special attention to taiwan’s pharmaceutical track and trace system, providing a description of taiwan’s pharmaceutical track and trace regime and the elements necessary for its success, its weaknesses, and opportunities for growth in a global track and trace system. by integrating the provisions of taiwan’s pharmaceutical affairs act, associated regulations, and data from various sources, the taiwanese government has successfully created a comprehensive track and trace system for pharmaceutical products. integration among government systems in taiwan further enhances the track and trace ecosystem’s comprehensiveness, enabling data to undergo various verification and auditing processes. finally, this article will argue that national track and trace systems should be interoperable with other national and regional systems to guarantee complete protection of the pharmaceutical supply chain. therefore, this article will conclude with a proposal for a worldwide unified, interoperable, and digital platform for pharmaceutical track and trace. ————————————————————————————— * associate professor of law, national yang ming chiao tung university school of law (markshope@nycu.edu.tw). the author would like to give a special thanks to hsin-mei huang for her valuable research assistance on this article. this article was supported by a grant from the national science and technology council of taiwan (nstc 111-2410-h-a49 -007-my2). the author interacted with the following artificial intelligence tools to create or assist in the creation of content included in this article: chatgpt plus 4.0. for a discussion on best practices for disclosing the use of ai tools, see mark l. shope, best practices for disclosure and citation when using artificial intelligence tools, 112 geo. l.j. online 1 (2023). a previous version of this article was submitted to and presented at the 20th asian law institute conference held in singapore on 31 may 1 june 2023. a similar presentation was made at the asian law scholars conference at the university of washington school of law on 14-15 september 2023. indiana health law review [vol. 22:63 64 i. introduction there is currently no unified, comprehensive transnational pharmaceutical track and trace regime.1 “unified” for purposes of this article means unified across both legal jurisdictions and among business trading partners. “comprehensive” in this sense means the integration of all potential sources of data intelligence and utilization of the latest technologies. the lack of a unified, comprehensive transnational pharmaceutical track and trace regime creates a multitude of challenges for the transnational movement of pharmaceutical goods. this article will explore these ideas of “unified” and “comprehensive” by first comparing three different regimes: the united states, european union, and taiwan. the article will discuss the challenges of operating in disparate systems and attempt to provide suggestions for harmonizing the transnational pharmaceutical supply chain regime. pharmaceutical supply chains, like any other supply chain, suffer from multiple challenges. 2 however, the consequences for a disrupted pharmaceutical supply chain are arguably more serious due to the fact that pharmaceuticals are so intimately tied to our health. 3 the journey of a prescription drug from manufacture to consumption is incredibly complex. 4 the impact of a flawed supply chain resonates across various facets of business operations, emphasizing the critical importance of maintaining its integrity and efficiency. 5 on the human side, flaws in the pharmaceutical supply chain can result in harms to the health of citizens, resulting in possible economic and other social impacts due to the health of a nation’s citizens. 6 therefore, a harmonized system is crucial for the health and economic wellbeing of all citizens. the following discussion will explore how three different regions are taking steps to secure the pharmaceutical supply chain, ensuring the safety of their populations. these three jurisdictions, each with their unique challenges and approaches, illustrate efforts to secure pharmaceutical supply chains. but the ————————————————————————————— 1. this would include a regime that goes beyond the 1994 wto agreement on trade in pharmaceutical products and would include all aspects of the movement of pharmaceuticals, described in more detail in the various regimes described in this article. see generally general agreement on tariffs and trade: trade in pharmaceutical products, l/7430 (mar. 25, 1994), gatt at 1–3 (1994) [hereinafter pharma agreement]. 2. edward sweeney, the big challenges for supply chains in 2022, world econ. f. (jan. 19, 2022), https://www.weforum.org/agenda/2022/01/challenges-supply-chains-covid19-2022 [https://perma.cc/2cqy-fja8]. 3. beth weinman et al., the american medical product supply chain: will covid-19 drive manufacturing back home?, 76 food & drug l.j. 235, 236 (2021). 4. robin feldman, designing disruption in pharmaceuticals, 28 bos. univ. j. sci. & tech. l. 1, 5–6 (2021) (describing the journey of a pharmaceutical). 5. see scott j. shackelford et. al., securing the internet of healthcare, 19 minn. j.l. sci. & tech. 405, 411 (2018) (noting how medical devices are susceptible to malware attacks through the supply chain). 6. see mariana p. socal et al., the pandemic and the supply chain: gaps in pharmaceutical production and distribution, 111 am. j. pub. health 635, 635–39 (2021). https://perma.cc/2cqy-fja8 https://www.weforum.org/agenda/2022/01/challenges-supply-chains-covid19-2022 2025] towards global harmonization 65 article will also highlight the need for interoperability among pharmaceutical supply chains, arguing for a worldwide unified, interoperable, and digital platform for pharmaceutical track and trace. ii. united states: the drug supply chain security act title ii of the drug quality and security act (“dqsa”), commonly cited as the drug supply chain security act (“dscsa”), was enacted on november 27, 2013, and outlines requirements for the tracing of pharmaceuticals through the pharmaceutical supply chain, exchange of pertinent information between stakeholders in that pharmaceutical supply chain, and placing product identifiers on packages.7 the dscsa defines separate and unique requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers with respect to transactions involving prescription drugs. 8 the dscsa calls for the united states secretary of health and human services to issue draft guidance documents establishing “standards for the interoperable exchange of transaction information, transaction history, and transaction statements” in order to comply with manufacturer requirements, wholesale distributor requirements, dispenser requirements, and repackager requirements under the dscsa. 9 these standards should “comply with a form and format developed by a widely recognized international standards development organization.”10 there have been several milestones for the implementation of the dscsa over the last 10 years, but the dscsa becomes fully effective in november of 2023, when the rules for an interoperable, electronic system of tracing products will go into effect. 11 the dscsa calls for the drafting of guidance documents establishing “standards for the interoperable exchange of transaction information, transaction history, and transaction statements” in order to comply with stakeholder requirements under the dscsa. 12 reference to transaction information includes information such as the name of the product, its dosage, its national drug code (“ndc”), its lot number, the container size and number, the date of the transaction and shipment, transferor details, and transferee details. 13 reference to transaction history includes a statement of the transaction ————————————————————————————— 7. drug supply chain security act, 21 u.s.c. §§ 360eee–360eee-4; the dscsa specifically covers “product,” meaning (subject to certain exceptions) “a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution).” id. § 360eee(13). 8. 21 u.s.c.a. § 360eee-1(a)(1) (west 2013) (“if an entity meets the definition of more than one of the entities listed [then] such entity shall comply with all applicable requirements in this section, but shall not be required to duplicate requirements.”). 9. id. § 360eee-1(a)(2)(a). 10. id. 11. id. § 360eee-1(g)(1). 12. id. § 360eee-1(a)(2)(a) (emphasis added). 13. 21 u.s.c. § 360eee(26). indiana health law review [vol. 22:63 66 information for every preceding transaction tracing back to the product’s original manufacturer. 14 the transaction statement refers to a statement indicating that the entity transferring ownership (a) is authorized as required under the [dscsa]; (b) received the product from a person that is authorized as required under the [dscsa]; (c) received transaction information and a transaction statement from the prior owner of the product . . . ; (d) did not knowingly ship a suspect or illegitimate product; (e) had systems and processes in place to comply with verification requirements . . . ; (f) did not knowingly provide false transaction information; and (g) did not knowingly alter the transaction history. 15 the term “transaction” under the dscsa means “the transfer of product between persons in which a change of ownership occurs.” 16 therefore, a transaction, in theory, would not include moving a product from a warehouse to a pharmacy if these facilities are owned by the same entity and no change of ownership occurs. a. dscsa stakeholder requirements the dscsa defines separate and unique requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers with respect to transactions involving covered products. 17 1. dscsa manufacturer18 requirements a. information exchange and retention currently under the dscsa, 19 manufacturers are required to furnish a ————————————————————————————— 14. id. § 360eee(25). 15. id. § 360eee(27). 16. id. § 360eee(24)(a). 17. 21 u.s.c.a. § 360eee-1(a)(1) (west 2013). 18. a manufacturer is: (a) a person that holds an application approved under section 355 of this title or a license issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product; (b) a co-licensed partner of the person described in subparagraph (a) that obtains the product directly from a person described in this subparagraph or subparagraph (a) or (c); or (c) an affiliate of a person described in subparagraph (a) or (b) that receives the product directly from a person described in this subparagraph or subparagraph (a) or (b). id. § 360eee(10). 19. see generally infra section ii.d. this article was drafted before the dscsa became fully effective in november of 2023. 2025] towards global harmonization 67 subsequent owner with transaction history, transaction information, and a transaction statement. 20 manufacturers must maintain this transaction history, transaction information, and a transaction statement for 6 years. 21 manufacturers must have this information ready to provide to the u.s. government for a product recall or for investigating a suspect or illegitimate product. 22 with certain exceptions, manufacturers are expected to present the transaction information, transaction history, and transaction statement in an “electronic format.”23 b. product identifier under the dscsa, a manufacturer must place a “product identifier” 24 on each package and homogenous case, and they must maintain the product identifier information for a period of 6 years. 25 c. trading partners the dscsa requires that trading partners be authorized trading partners. 26 for purposes of the dscsa, trading partner means: (a) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or (b) a third-party logistics provider 27 from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product. 28 ————————————————————————————— 20. id. § 360eee-1(b)(1)(a)(i)–(ii). 21. id. 22. id. § 360eee-1(b)(1)(b). 23. id. § 360eee-1(b)(1)(c)(i). 24. “product identifier” means “a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” 21 u.s.c. § 360eee(14). 25. 21 u.s.c.a. § 360eee-1(b)(2)(a) (west 2013). 26. id. § 360eee-1(b)(3). 27. see id. § 360eee(22) (“the term third-party logistics provider means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”). 28. id. § 360eee(23). indiana health law review [vol. 22:63 68 d. system of verification manufacturers are obliged to establish systems for identifying and investigating products that are suspect or illegitimate.29 when a verification request is received, manufacturers are required to inform the requester if the product identifier, which includes the standardized numerical identifier, matches the product identifier on the product. 30 should the product identifier not match the manufacturer’s, then the product is considered a “suspect product” 31 subject to further investigation. 32 in the event that the product is considered an illegitimate product, 33 the manufacturer must state this in response to the request for verification. 34 the manufacturer must use a “secure electronic database” of its own or a third-party.35 the database may allow access to relevant stakeholders, “as appropriate.” 36 2. wholesale distributor37 requirements a. information exchange and retention currently under the dscsa, 38 a wholesale distributor is permitted to take ownership of a product only if the preceding owner has supplied the transaction history, transaction information, and a transaction statement. 39 what ————————————————————————————— 29. id. § 360eee-1(b)(4). 30.id. § 360eee-1(b)(4)(c). 31. a “suspect product” is: a product for which there is reason to believe that such product — (a) is potentially counterfeit, diverted, or stolen; (b) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (c) is potentially the subject of a fraudulent transaction; or (d) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans. id. § 360eee(21). 32. id. § 360eee-1(b)(4)(c). 33. an “illegitimate product” is defined as a product for which credible evidence shows that the product — (a) is counterfeit, diverted, or stolen; (b) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (c) is the subject of a fraudulent transaction; or (d) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans. id. § 360eee(8). 34. id. § 360eee-1(b)(4)(c). 35. id. § 360eee-1(b)(4)(d). 36. id. 37. a wholesale distributor is “a person (other than a manufacturer, a manufacturer’s colicensed partner, a third-party logistics provider, or repackager) engaged in wholesale distribution (as defined in section 353(e)(4) of this title).” id.§ 360eee(29). 38. see infra section ii.d. 39. 21 u.s.c. § 360eee-1(c)(1)(a)(i). 2025] towards global harmonization 69 information the wholesale distributor must provide to a subsequent owner depends if the “wholesale distributor purchased a product directly from the manufacturer, [an] exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer.” 40 if yes, the wholesale distributor must provide a transaction statement stating that the “wholesale distributor . . . purchased the product directly from the manufacturer, [an] exclusive distributor of the manufacturer, or a repackager that purchased the product directly from the manufacturer” 41 and the transaction history and transaction information.42 if not, the wholesale distributor must provide a transaction statement, transaction history, and transaction information. 43 similar to manufacturers, wholesale distributors must provide information to the u.s. government in cases of product recalls or for investigations into suspect or illegitimate product.44 b. product identifier, trading partners, and system of verification with certain exceptions, a wholesale distributor is allowed to conduct transactions only if the product is “encoded” with a product identifier. 45 the dscsa requires that trading partners be authorized trading partners. 46 wholesale distributors are required to have systems in place to identify and investigate suspect products and illegitimate products. 47 the wholesale distributor can use a “secure electronic database” developed and operated by itself or a third-party.48 the database owner may, when suitable, grant access to the data to other participants in the pharmaceutical supply chain. 49 c. product returns should a wholesale distributor receive a returned product and wish to redistribute the returned product, it must verify the product identifier. 50 ————————————————————————————— 40. id. § 360eee-1(c)(1)(a)(ii)(i)(aa). 41. id. § 360eee-1(c)(1)(a)(ii)(i)(aa)(aa). 42. id. § 360eee-1(c)(1)(a)(ii)(i)(aa)(bb). 43. id. § 360eee-1(c)(1)(a)(iii). the difference here would be that the transaction statement does not need a statement that “the wholesale distributor purchased a product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer.” id. 44. id. § 360eee-1(c)(1)(c). 45. id. § 360eee-1(c)(2). 46. id. § 360eee-1(c)(3). 47. id. § 360eee-1(c)(4)(b). 48. id. § 360eee-1(c)(4)(c). 49. id. 50. id. § 360eee-1(c)(4)(d). indiana health law review [vol. 22:63 70 3. dscsa dispenser51 requirements a. information exchange and retention a dispenser is prohibited from taking ownership of a product unless it receives the transaction history, transaction information, and a transaction statement from the previous owner. 52 when transferring ownership, the dispenser must also provide transaction history, transaction information, and a transaction statement for the product.53 the dispenser does not need to provide the transaction history, transaction information, and a transaction statement for the product when dispensing to a patient, when returning the product, or selling to another dispenser “to fulfill a specific patient need.”54 a dispenser should keep transaction information, transaction history, and transaction statements for at least 6 years 55 and must provide it to government officials in case of an investigation.56 b. product identifier, trading partners, and system of verification a dispenser is only permitted to handle products if they are “encoded” with a product identifier. 57 a dispenser may only deal with authorized trading partners. 58 a dispenser must also establish systems to effectively comply with regulations concerning suspect products and illegitimate products. 59 4. dscsa repackager60 requirements a. information exchange and retention a repackager can only accept a product when it includes a transaction ————————————————————————————— 51. a dispenser: means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor. 21 u.s.c. § 360eee(3)(a). 52. id. § 360eee-1(d)(1)(a)(i). 53. id. § 360eee-1(d)(1)(a)(ii). 54. id. § 360eee-1(d)(1)(a)(ii). 55. id. § 360eee-1(d)(1)(a)(iii). 56. id. § 360eee-1(d)(1)(d). 57. id. § 360eee-1(d)(2). 58. id. § 360eee-1(d)(3). 59. id. § 360eee-1(d)(4)(a) 60. a repackager is “a person who owns or operates an establishment that repacks and relabels a product or package for—(a) further sale; or (b) distribution without a further transaction.” 21 u.s.c. § 360eee(16). 2025] towards global harmonization 71 history, transaction information, and a transaction statement 61 and must provide such a transaction history, transaction information, and a transaction statement to any subsequent owner.62 the transaction information, transaction history, and transaction statement must be captured and maintained for at least 6 years 63 and be provided to government officials in the course of investigations into suspect or illegitimate products. 64 b. product identifier, trading partners, and system of verification a repackager must use a product identifier for the product 65 and must maintain this product identifier information for 6 years. 66 a repackager can only engage in transactions with a product identifier. 67 a repackager can only deal with authorized trading partners. 68 a repackager must establish systems to effectively comply with regulations concerning suspect products and illegitimate products.69 b. dscsa enhanced drug distribution security on november 27, 2023, the dscsa called for an enhanced method of electronic tracing of pharmaceutical products. 70 this system requires the following: • transaction information and transaction statements are required to be “exchanged in a secure, interoperable, electronic manner.” 71 the standards for the exchange are to be established through guidance documents issued by the fda. 72 • the transaction information shall contain the product identifier “at the package level for each package included in the transaction.” 73 • systems must be in place to confirm the product’s authenticity “at the package level” pursuant to guidance documents issued by the fda. 74 • systems must be in place to respond to requests by appropriate government agencies for recall purposes or for investigating suspect or ————————————————————————————— 61. id. § 360eee-1(e)(1)(a)(i). 62. id. § 360eee-1(e)(1)(a)(ii). 63. id. § 360eee-1(e)(1)(a)(iii). 64. id. § 360eee-1(e)(1)(c). 65. id. § 360eee–1(e)(2)(a)(i). 66. id. § 360eee–1(e)(2)(a)(ii). 67. id. § 360eee–1(e)(2)(a)(iii). 68. id. § 360eee–1(e)(3). 69. id. § 360eee–1(e)(4). 70. id. § 360eee–1(g). 71. id. § 360eee–1(g)(1)(a). 72. id. 73. id. § 360eee–1(g)(1)(b). 74. id. § 360eee–1(g)(1)(c). indiana health law review [vol. 22:63 72 illegitimate products.75 • systems must be in place “to produce the transaction information for each transaction going back to the manufacturer” if requested by the government or trading partner for investigating suspect or illegitimate product.76 • systems must be in place to “associate” a returned product with the transaction information and transaction statement that is associated with that specific returned product. 77 the fda announced a one-year “stabilization period” to “allow trading partners to implement, troubleshoot and mature their electronic interoperable systems.” 78 in addition, fda is issuing exemptions to small dispensers, “and where applicable their trading partners” beyond this initial stabilization period until november 27, 2026.79 these extensions recognize that certain stakeholders need more time to make such a big change to their systems. c. dscsa guidance documents and pilot projects the fda has been busy issuing guidance documents 80 and has established pilot projects to realize the enhanced drug distribution system explained above. 81 there is a host of guidance from the fda. 82 consequently, the fda’s guidance and pilot programs have played a crucial role in developing this system. d. dscsa sunset on november 27, 2023, the provision and receipt of transaction history will no longer be necessary. 83 this presumably is because this is the date that the enhanced drug distribution security system begins and such information will ————————————————————————————— 75. id. § 360eee–1(g)(1)(d). 76. id. § 360eee–1(g)(1)(e)(i)–(ii). 77. id. § 360eee–1(g)(1)(f). 78. dscsa compliance policies establish 1-year stabilization period for implementing electronic systems, u.s. food & drug admin. (aug. 30, 2023), https://www.fda.gov/drugs/ drug-safety-and-availability/dscsa-compliance-policies-establish-1-year-stabilization-periodimplementing-electronic-systems. 79. waivers and exemptions beyond the stabilization period, u.s. food & drug admin. (oct. 9, 2024), https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-andexemptions-beyond-stabilization-period. 80. id. § 360eee–1(h). 81. id. § 360eee–1(j). 82. see generally u.s. food & drug admin., dscsa standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs guidance for industry (sept. 2023), https://www.fda.gov/media/171796/download [https:// perma.cc/7lt7-nvf3]. 83. 21 u.s.c. § 360eee–1(k)(1). https://www.fda.gov/media/171796/download https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and https://www.fda.gov/drugs 2025] towards global harmonization 73 be captured by the system. e. dscsa conclusion the dscsa represents a significant step in securing the pharmaceutical supply chain in the united states, outlining clear and detailed requirements for all stakeholders. the dscsa is one example of a regulatory frameworks that aims to protect consumers and ensure the integrity of pharmaceutical supply chains. but is this largely national regime enough in a globalized world? the article will continue to look at eu and taiwanese regulations, highlighting that interoperability between jurisdictions is necessary for full realization of the goals of a pharmaceutical track and trace regime. iii. the eu falsified medicines directive the eu’s falsified medicines directive aims to combat “falsified” medicines in the supply chain. 84 while both the falsified medicines directive and dscsa aim to secure the pharmaceutical supply chain, the language and provisions of the eu’s falsified medicines directive are more explicitly oriented towards the elimination of falsified medicines. 85 commission delegated regulation (eu) 2016/161 explains the safety features necessary on pharmaceutical packaging and how to verify packages. 86 these features are designed to ensure the authenticity of the medicines and to prevent counterfeit (or “falsified”) products from entering the legal supply chain. 87 a. authorization, good practices, trading partners similar to the idea of authorized trading partners under the dscsa, 88 eu regulations require that the manufacture of medicinal products be authorized. 89 an entity holding such a manufacturing authorization must comply with good manufacturing practices and good distribution practices. 90 an entity holding such a manufacturing authorization must conduct audits (either by themselves ————————————————————————————— 84. directive 2001/83/ec of nov. 6, 2001, on the community code relating to medicinal products for human use, 2001 o.j (l 311) 67, 67 (amended by directive 2011/62/eu, of the european parliament and of the council of 8 june 2011 amending directive 2001/83/ec, 2011 o.j. (l 174) 74). 85. see directive 2011/62/eu, of the european parliament and of the council of 8 june 2011 amending directive 2001/83/ec on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, 2011 o.j. (l 174) 74, 76. the dscsa does refer to “suspect product” and “illegitimate product” but generally focuses on tightening the supply chain of legitimate product. 86. commission delegated regulation (eu) 2016/161, art. 3, 2016 o.j. (l 32) 1, 7. 87. id. 88. 21 u.s.c.a. § 360eee–1(b)(3) (west 2013). 89. council directive 2001/83, art. 40(1) 2001 o.j. (l 311) 67, 82 (ec). 90. id. at art. 46(f). indiana health law review [vol. 22:63 74 or through third-parties) to ensure the proper manufacture and distribution of active substances. 91 an entity holding such a manufacturing authorization must inform competent authorities and the holders of marketing authorizations if products are, or are suspected to be, falsified. 92 an entity holding such a manufacturing authorization must verify that entities they are obtaining active substances from (trading partners, under the dscsa) are properly registered. 93 1. import member states are responsible for ensuring that the manufacturing, importation, and distribution of products adhere to good manufacturing practices and good distribution practices. 94 to import products, the products must be manufactured in accordance with good manufacturing practices and must be accompanied by written confirmation from the exporting country’s government. 95 this confirmation should verify that the manufacturing standards adhered to by the plant producing the exported active substance meet or exceed those established by the eu, among other requirements. 96 2. serialization similar to ideas in the dscsa, the outer or immediate packaging of medicinal products must have a method to confirm the genuineness of the pharmaceutical product and distinguish individual packages. 97 the outer or immediate packaging must also include a method for determining whether the packaging has been tampered. 98 3. distribution authorization distributors must obtain a distribution authorization. 99 an entity holding such a distribution authorization must maintain records for transactions in medicinal products received, sent, or brokered that includes things like date, name, quantity, supplier or consignee details, and batch number. 100 ————————————————————————————— 91. id. 92. id. at art. 46(g). 93. id. at art. 46(h). 94. id. at art. 46b(1). 95. id. at art. 46b(2). 96. id. 97. id. at art. 54(o). 98. id. 99. id. at art. 79. 100. id. at art. 80(e). 2025] towards global harmonization 75 4. safety features under regulation 2016/161 the commission delegated regulation (eu) 2016/161 (the “safety features regulations”) supplements directive 2001/83/ec by establishing rules for safety features on packaging. 101 the safety features regulations reiterate that manufacturers must affix a unique identifier to the packaging of medicinal products, 102 of which should be encoded in a two-dimensional barcode. 103 manufacturers, wholesalers, and others supplying medicinal products should verify “the authenticity of the unique identifier” while simultaneously checking “the integrity of the anti-tampering device.” 104 the manufacturer needs to keep records: of every operation he performs with or on the unique identifier on a pack of medicinal product for at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution . . . and shall provide those records to competent authorities on request.105 a repositories system should be set up and maintained by a non-profit entity or group of non-profit entities established in the european union by pharmaceutical supply chain stakeholders that contains data on the safety characteristics of products. 106 the repository system must function in union with the other repositories in the system, ensuring seamless communication regardless of the service provider. 107 the repository must be equipped with apis that can facilitate communication “with the software used by wholesalers, persons authorised or entitled to supply medicinal products to the public and, where applicable, national competent authorities.” 108 the repository should also preserve an “audit trail of all operations concerning a unique identifier, of the users performing those operations and the nature of the operations.” 109 5. conclusion of the eu’s regime the eu’s falsified medicines directive and the commission delegated ————————————————————————————— 101. commission delegated regulation (eu) 2016/161, art. 5, 2016 o.j. (l 32) 1, 8. 102. id. at art. 4. 103. id. at art. 5. 104. id. at art. 35. 105. id. 106. id. at art. 31; see emvo mission, euro. med. verification org. (last visited oct. 21, 2024), https://emvo-medicines.eu/ [https://perma.cc/w7ag-7xte] (“the european medicines verification organisation (emvo) is a belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines.”). 107. commission delegated regulation (eu) 2016/161, art. 35, 2016 o.j. (l 32) 1, 17–18. 108. id. at 18. 109. id. https://perma.cc/w7ag-7xte https://emvo-medicines.eu indiana health law review [vol. 22:63 76 regulation provide a robust system to combat falsified medicines. the regulations require stringent authorization, adherence to good manufacturing and distribution practices, and the implementation of safety features on pharmaceutical packaging. these measures reflect a concerted effort by the eu to safeguard public health by ensuring the authenticity and safety of medicinal products. together with the dscsa, these regimes cover a significant part of the pharmaceutical supply chain. iv. taiwan’s pharmaceutical track and trace regime a. background of the pharmaceutical affairs act and the establishment of a track and trace framework under article 6-1 the management of pharmaceutical affairs (yàoshì) is outlined in the pharmaceutical affairs act (the “act”) of taiwan. 110 the term pharmaceutical affairs includes matters relating to medicaments (yàowù), pharmaceutical firms (yàoshāng), pharmacies (yàojú), and related matters (yǒuguānshìxiàng). 111 the competent authorities for purposes of the act are the ministry of health and welfare of taiwan and various local governments. 112 the term medicaments includes both drugs 113 (yàopǐn) and medical devices 114 (yīliáoqìcái)115 a pharmaceutical firm includes dealers (fànmàiyèzhě) and manufacturers (zhìzàoyèzhě) of drugs or medical devices. 116 a pharmacy for purposes of the act refers to a premises “managed by a pharmacist or an assistant pharmacist” and where “drugs are legally prepared and dispensed.” 117 pharmacies may dispense drugs and sell medical devices. 118 beyond the introductory general provisions in chapter i, the act delves into various aspects of pharmaceutical management. these include the administration of pharmaceutical firms (chapter ii), oversight of pharmacies and drug dispensation (chapter iii), drug registration and market approval (chapter iv), intellectual property related matters (chapter 4-1), regulation of medicament sales and manufacturing (chapter v), management of specific controlled and poisonous drugs (chapter vi), investigative procedures (chapter viii), imposition of fines (chapter ix), and additional supplementary provisions (chapter x). this comprehensive ————————————————————————————— 110. 藥事法 [pharmaceutical affairs act], art. 1 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2018), https://law.moj.gov.tw/ eng/lawclass/lawall.aspx?pcode=l0030001 [https://perma.cc/7t7r-qa83]. 111. id. 112. id. art. 2. 113. see id. art. 6 (containing the definition of drugs). 114. see id. art. 13 (containing the definition of medical devices). 115. id. art. 4. 116. id. art. 14. see also arts. 15–18 (for definitions of drug dealer, drug manufacturer, medical device dealer, and medical device manufacturer). 117. id. art. 19. 118. id. https://perma.cc/7t7r-qa83 https://law.moj.gov.tw 2025] towards global harmonization 77 approach addresses multiple facets of and acts as the foundation to the pharmaceutical industry in taiwan. article 6-1 of the act establishes the framework for a track and trace system for products covered under the act, and states: distributors and manufacturers of drugs categorized and announced by the central competent health authority, shall establish their own traceability system for tracing the source and tracking the flow of the drugs according to their industry modes. the central competent health authority shall establish the traceability report system in the preceding paragraph; the business in the preceding paragraph shall use electronic methods to declare the information of the traceability system. the electronic declaration method shall be prescribed by the central competent health authority. the regulations governing the establishment, matters to be recorded, examination and other matters to be complied with for the traceability system mentioned in the preceding paragraph shall be prescribed by the central competent health authority.119 the united states calls for a similar track and trace framework under the dscsa. 120 the european union also calls for a similar regime under its falsified medicines directive. 121 there are also numerous other countries throughout the world with similar track and trace systems, and in addition to taiwan, a number of countries in asia have country level track and trace ————————————————————————————— 119. id. art. 6-1. article 6–1 was introduced by presidential order (104) hua-zong-yi-yizi no. 10400140921 on december 2, 2015; violators of this article could be fined between nt$30,000 and nt$2,000,000. id. art. 92. 120. drug quality and security act, h.r. 3204, 113th cong. (2013). 121. see generally directive 2011/62/eu, of the european parliament and of the council of 8 june 2011 amending directive 2001/83/ec on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, 2011 o.j. (l 174) 74, 75. indiana health law review [vol. 22:63 78 regimes. 122 for example, south korea, 123 china, 124 india,125 and malaysia 126 all have some sort of track and trace regime. b. good distribution practice (“gdp”) and good manufacturing practice (“gmp”) framework the act provides the framework for the use of gdp and gmp standards. article 49 of the act stipulates that pharmaceutical dealers must exclusively buy and sell drugs or medical devices from verified sources or dealers possessing valid pharmaceutical dealer licenses. 127 article 53-1 of the act calls for certain business undertakings engaging in the distribution of pharmaceuticals to meet standards outlined in the western pharmaceuticals good distribution practice regulations and obtain a license from the authorities. 128 the western pharmaceuticals good distribution practice regulations and western pharmaceuticals distribution licenses are prescribed by the central competent health authority and discussed below. 129 article 57 of the act calls for medicament manufacturing factories to comply with the standards for ————————————————————————————— 122. see digital law asia, nat’l yang ming chiao tung u. sch. l. https://digital. law.nycu.edu.tw/pharma/ [https://perma.cc/w98j-y4s2] (last visited oct. 26, 2024) (mapping of these various track and trace systems). 123. guideline for pharmaceutical serialization system [the first edition], hira, https://www.hira.or.kr/bbsdummy.do?pgmid=hiraj030000001000&brdscnbltno=4&brdbltn o=46912#none [https://perma.cc/6ran-e8ks] (last visited oct. 26, 2024). 124. china nmpa rolls out drug information traceability system for key drug products, pharma to market (nov. 13, 2020), https://www.pharmatomarket.com/china-nmpa-rolls-outdrug-information-traceability-system-for-key-drug-products/ [https://perma.cc/9sxp-6cc2]. 125. anil k. sinha, indian government implements track and trace system for pharmaceuticals, in gs1 healthcare reference book 2016–2017 66, 66 (gs1 ed., 8th ed. n.d.). 126. pelaksanaan projek rintis pharmaceutical track & trace, nat’l pharm. regul. agency (nrpa) ministry of health malay. (july 2022), https://www.npra.gov.my/ index.php/en/component/content/article/225-english/1527375-pelaksanaan-projek-rintispharmaceutical-track-trace.html?itemid=1391 [https://perma.cc/eh8a-98d2]. see also asia: malaysia’s npra details pilot project for track and trace system, trpma (july 28, 2022), https://trpma.org.tw/eng/news/news_5039 [https://perma.cc/emt6-y94w]. 127.藥事法 [pharmaceutical affairs act], art. 49 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2018), https://law.moj.gov.tw/eng/ lawclass/lawall.aspx?pcode=l0030001 [https://perma.cc/7t7r-qa83]. 128. id. art. 53–1 (“business undertakings engaged in wholesaling, importing and exporting pharmaceuticals, their product procuring, holding, supplying related to the quality management, organization and personnel, premises and equipment, documentation, operation procedures, customer complaints, returns and recalls, outsourced activities, self-inspections, transportation and other pharmaceuticals distribution practice, shall meet the standard of western pharmaceuticals good distribution practice regulations, and shall obtain the western pharmaceuticals distribution license upon the inspection and approval from the central competent health authority.”). 129. id. https://perma.cc/7t7r-qa83 https://law.moj.gov.tw/eng https://perma.cc/emt6-y94w https://trpma.org.tw/eng/news/news_5039 https://perma.cc/eh8a-98d2 https://www.npra.gov.my https://perma.cc/9sxp-6cc2 https://www.pharmatomarket.com/china-nmpa-rolls-out https://perma.cc/6ran-e8ks https://www.hira.or.kr/bbsdummy.do?pgmid=hiraj030000001000&brdscnbltno=4&brdbltn https://perma.cc/w98j-y4s2 https://digital 2025] towards global harmonization 79 medicament factory establishment 130 and register pursuant to the factory management act. 131 furthermore, medicament manufacturing activities (including overseas manufacturing factories) must comply with gmp. 132 of note, the act states that government authorities can “send personnel overseas to inspect such foreign manufacturing factories on a periodical basis or as necessary.”133 1. western pharmaceuticals good distribution practice regulations the western pharmaceuticals good distribution practice regulations are promulgated pursuant to article 53-1 of the pharmaceutical affairs act (“gdp regulations”). 134 the gdp regulations contain ten tables covering certain aspects of the pharmaceutical distribution process. 135 the various standards for implementing a quality management system and conducting system reviews are presented in table 1. 136 table 2 delineates the criteria for organizational structure and personnel. 137 the standards concerning premises and equipment are detailed in table 3, 138 while those related to documentation are enumerated in table 4. 139 operational procedures standards can be found in table 5, 140 and the criteria for handling complaints, returns, and recalls are outlined in table 6.141 table 7 addresses the standards for outsourced activities, 142 and table 8 elaborates on the self-inspection requirements. 143 finally, transportation standards are illustrated in table 9. 144 ————————————————————————————— 130. 藥物製造工廠設廠標準 [standards for medicament factory establishments], art. 57 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2013), https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030008 [https://perma. cc/x8rr-zu6y]. 131. 藥事法 [pharmaceutical affairs act], art. 57 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2018), https://law.moj.gov. tw/eng/lawclass/lawall.aspx?pcode=l0030001 [https://perma.cc/7t7r-qa83]. 132. id. 133. id. 134. 西藥優良運銷準則 [western pharmaceuticals good distribution practice regulations] art. 1 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2017), https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030086 [https://perma.cc/5dbf-ks9c]. 135. id. 136. id. art. 2. 137. id. art. 3. 138. id. art. 4. 139. id. art. 5. 140. id. art. 6. 141. id. art. 7. 142. id. art. 8. 143. id. art. 9. 144. id. art. 10. https://perma.cc/5dbf-ks9c https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030086 https://perma.cc/7t7r-qa83 https://law.moj.gov https://perma https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030008 indiana health law review [vol. 22:63 80 2. pharmaceutical good manufacturing practice regulations the pharmaceutical good manufacturing practice regulations are promulgated under paragraph 5 of article 57 of the act. 145 the pharmaceutical good manufacturing practice regulations are basically organized into sections covering western pharmaceuticals, chinese pharmaceuticals, and medical devices. a. western pharmaceuticals there is only one article covering western pharmaceuticals. it states: the manufacturing, processing, re-packaging, packaging, storage, and distribution of western medicinal products, including those only for export, shall comply with the good manufacturing practices for western medicinal products adopted by the competent central health authority with reference to the pharmaceutical inspection convention and pharmaceutical inspection co-operation scheme (pic/s). implementation of the aforesaid good manufacturing practices may be phased in; the items to which the phased-in implementation applies and the related schedules shall be announced by the competent central health authority. 146 pic/s publishes a guide to good manufacturing practice for medicinal products including its detailed annexes. 147 part i covers medicinal products. 148 part ii covers starting materials. 149 the annexes cover other specific areas of activity (21 annexes).150 taiwan acceded to the pic scheme in january of 2013.151 taiwan was the 43rd member admitted to the pic scheme, ahead of some neighboring countries, demonstrating its government’s commitment to ————————————————————————————— 145. id. art. 1. 146. id. art. 3. 147. pharmaceutical inspection conventional–pharmaceutical inspection cooperation scheme [pic/s], guide to good manufacturing practice for medicinal products, (aug. 25, 2023), https://picscheme.org/docview/6605 [https://perma.cc/6sgb-bnsq]. 148. pharmaceutical inspection conventional–pharmaceutical inspection cooperation scheme [pic/s], guide to good manufacturing practice for medicinal products part i, (aug. 25, 2023), https://picscheme.org/docview/6606 [https://perma.cc/yx4k-2zvr]. 149. pharmaceutical inspection conventional–pharmaceutical inspection cooperation scheme [pic/s], guide to good manufacturing practice for medicinal products part ii, (aug. 25, 2023), https://picscheme.org/docview/6607 [https://perma.cc/q33w-dpab]. 150. pharmaceutical inspection conventional–pharmaceutical inspection cooperation scheme [pic/s], guide to good manufacturing practice for medicinal products, annexes, (aug. 25, 2023), https://picscheme.org/docview/6608 [https://perma.cc/2qc5-ez4e]. 151. pharmaceutical inspection conventional–pharmaceutical inspection cooperation scheme [pic/s], list of pic/s participating authorities, https://picscheme.org/en/ members?paysselect=tw [https://perma.cc/j6ns-6efr] (last visited sept. 22, 2024). https://perma.cc/j6ns-6efr https://picscheme.org/en https://perma.cc/2qc5-ez4e https://picscheme.org/docview/6608 https://perma.cc/q33w-dpab https://picscheme.org/docview/6607 https://perma.cc/yx4k-2zvr https://picscheme.org/docview/6606 https://perma.cc/6sgb-bnsq https://picscheme.org/docview/6605 2025] towards global harmonization 81 quality standards in pharmaceutical manufacturing. 152 b. chinese pharmaceuticals articles 4-59 in chapter 2 of the pharmaceutical good manufacturing practice regulations deal with the “manufacturing, processing, re-packaging and packaging of raw materials of chinese herbal medicine.” 153 these articles cover most areas of the manufacturing environment from sanitation to reporting. 154 the government body overseeing chinese medicine is the department of chinese medicine and pharmacy, ministry of health and welfare. 155 information regarding quality control of traditional chinese medicines is also published on the taiwan ministry of health and welfare website.156 c. medical devices articles 60-145 in part 3 of the pharmaceutical good manufacturing practice regulations deal with medical devices. 157 in this part, “standards related to the design, development, production, installation, and servicing of medical devices are prescribed in accordance with the contents of medical device quality management system of [iso 13485:2016].” 158 this iso standard “specifies requirements for a quality management system where an organization ————————————————————————————— 152. taiwan ministry of health and welfare, pic/s入會五大效益持續發酵, 台灣製 藥大”藥”進 [five benefits of joining pic/s for taiwan’s pharmaceutical industry], https://www. mohw.gov.tw/cp-3214-23150-1.html [https://perma.cc/z6dj-4brz] (last visited sept. 22, 2024). 153. 西藥優良運銷準則 [western pharmaceuticals good distribution practice regulations] art. 4–59 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2017), https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030086 [https://perma.cc/5dbf-ks9c]. these sections include general provisions, environmental sanitation, factory buildings and facilities, facilities, organization and personnel, management of raw materials and product containers and caps, manufacturing process control, management of packaging and labeling, storage, shipping and sales, quality control, records and reports, handling of complaints and returned products, and pharmaceuticals for use in clinical trials. 154. id. 155. see department of chinese medicine and pharmacy, ministry of health and welfare, (oct. 19, 2018), https://www.mohw.gov.tw/cp-3779-39358-2.html [https://perma. cc/8dw6-zh7q]. 156. quality control of tcm, ministry of health & welfare (nov. 23, 2023), https://www.mohw.gov.tw/cp-3701-58121-2.html [https://perma.cc/6c4f-9u54]. 157.西藥優良運銷準則 [western pharmaceuticals good distribution practice regulations] art. 60–145 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2017), https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030086 [https://perma.cc/5dbf-ks9c]. the sections encompass general provisions, quality management system, management responsibility, resource management, product realization, measurement, analysis and improvement, essential mode, and medical devices for use in clinical trials. 158. id. art. 60. https://perma.cc/5dbf-ks9c https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030086 https://perma.cc/6c4f-9u54 https://www.mohw.gov.tw/cp-3701-58121-2.html https://perma https://www.mohw.gov.tw/cp-3779-39358-2.html https://perma.cc/5dbf-ks9c https://law.moj.gov.tw/eng/lawclass/lawall.aspx?pcode=l0030086 https://perma.cc/z6dj-4brz https://www indiana health law review [vol. 22:63 82 needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.” 159 c. the regulations governing the trace and track system for medicinal products and the taiwanese pharmaceutical track and trace ecosystem article 6-1 of the act sets the framework for a track and trace system, mandating that both distributors and manufacturers create a system for traceability.160 the act requires the competent health authority to develop a report system to declare required information. 161 the method of electronic declaration is to be determined by the central competent health authority. 162 importantly, this central authority is responsible for creating regulations, 163 which includes the regulations governing the trace and track system for medicinal products. 164 recall that the taiwan regulatory regime also calls for gdp and gmp standards.165 the taiwan government has created tools available to the public to help assist industry in complying with this regulatory framework. for example, the taiwan food and drug administration (“tfda”) maintains a dedicated section on its website for track and trace information.166 this website features news and announcements, 167 access to the declaration system, 168 audio-visual training ————————————————————————————— 159. int’l stans. org., iso 13485:2016, medical devices — quality management systems — requirements for regulatory purposes, (2016) https://www.iso.org/standard/59752.html [https://perma.cc/6mqt-et28]. 160. 藥事法 [pharmaceutical affairs act], art. 1–6 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2018), https://law.moj.gov.tw/eng/ lawclass/lawall.aspx?pcode=l0030001 [https://perma.cc/7t7r-qa83]. 161. id. 162. id. 163. id. 164. 藥品追溯或追蹤系統申報及管理辦法 [regulations governing the trace and track system for medicinal products] art. 1 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2016), https://law.moj.gov.tw/eng/lawclass/lawall. aspx?pcode=l0030083 [https://perma.cc/u3mx-6qw6]. 165. see supra part b. 166. taiwan food & drug admin., pharmaceutical track and trace area, https://www.fda.gov.tw/tc/site.aspx?sid=9405&r=968484419 [https://perma.cc/2jut-qdg4] (last visited oct. 31, 2024). 167. taiwan food & drug admin., drug track and trace notice and announcement area, https://www.fda.gov.tw/tc/sitelist.aspx?sid=9445 [https://perma.cc/4q44-cjyf] (last visited oct. 31, 2024). 168. taiwan food & drug admin., drug track and trace declaration system, https://dtracebook.fda.gov.tw/ [https://perma.cc/3e5b-u9ms] (last visited oct. 31, 2024). https://perma.cc/3e5b-u9ms https://dtracebook.fda.gov.tw https://perma.cc/4q44-cjyf https://www.fda.gov.tw/tc/sitelist.aspx?sid=9445 https://perma.cc/2jut-qdg4 https://www.fda.gov.tw/tc/site.aspx?sid=9405&r=968484419 https://perma.cc/u3mx-6qw6 https://law.moj.gov.tw/eng/lawclass/lawall https://perma.cc/7t7r-qa83 https://law.moj.gov.tw/eng https://perma.cc/6mqt-et28 https://www.iso.org/standard/59752.html 2025] towards global harmonization 83 information, 169 and briefings. 170 furthermore, the tfda conducts 2-3 annual training sessions for both industry professionals and government representatives to enhance understanding and compliance with the track and trace system. 171 the tfda track and trace system utilizes data and statistical analysis to create reports. 172 the tfda also utilizes data from the national health insurance administration to regularly update information on counterfeit drugs, monitor shortages, and manage stockpiles. 173 the tfda track and trace system also shares information with various government entities and platforms to assist in the overall security of the pharmaceutical supply chain. 174 the taiwan government built system infrastructures to utilize statistical analysis to help the tfda and health bureaus. 175 this includes transaction information and inventory information and can be early indicators of negative anomalies. 176 the regulations governing the trace and track system for medicinal products were formulated under article 6.1.3 of the act (“track and trace regulations”).177 the track and trace regulations require distributors and manufacturers to “establish their own information system for tracing the source and tracking the flow of the medicinal products according to manufacturing, import, sale or export process and establish the information system and management measures.” 178 moreover, the central competent health authorities ————————————————————————————— 169. taiwan food & drug admin., login platform for audio-visual learning, https://www.fda.gov.tw/tc/sitelist.aspx?sid=9988 [https://perma.cc/7jeq-ysm3] (last visited oct. 31, 2024). 170. taiwan food & drug admin., drug track and trace declaration system information related to industry briefing sessions, https://www.fda.gov.tw/tc/sitelist.aspx?sid=10060 [https://perma.cc/kj73-l34b] (last visited oct. 31, 2024). 171. yang po-wen, section chief div. medicinal prod., taiwan food & drug admin., pharmaceutical track and trace system introduction and experience sharing (october 20, 2022) (on file with the author). 172. hsin-mei huang, pharmaceutical track and trace lecture series – an introduction to the taiwanese medicinal products traceability system, digital l. asia (feb. 10, 2023), https://digital.law.nycu.edu.tw/blog-post/zlfmfk/ [https://perma.cc/mbw8-9sj9] (citing yang po-wen, section chief div. medicinal prod., taiwan food & drug admin., pharmaceutical track and trace system introduction and experience sharing (october 20, 2022) (on file with the author)). the speech was part of the “pharmaceutical track and trace lecture series” cohosted by national yang ming chiao tung university school of law and the center for digital governance and legal innovation. 173. id. 174. id. (“the track and trace system is interfaced with district public health bureaus, hospitals, the controlled drugs management information system, and the medical resource dispatch and support system for emergency response (mrdss).”). 175. id. (noting that “the system has established a cross-reference and statistical analysis function, which is able to provide statistics, inquiries, and output of reports”). 176. id. 177. 藥品追溯或追蹤系統申報及管理辦法 [regulations governing the trace and track system for medicinal products] art. 1 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2016), https://law.moj.gov.tw/eng/lawclass/lawall. aspx?pcode=l0030083 [https://perma.cc/lmn5-l3lu]. 178. id. art. 2. https://perma.cc/lmn5-l3lu https://law.moj.gov.tw/eng/lawclass/lawall https://perma.cc/mbw8-9sj9 https://digital.law.nycu.edu.tw/blog-post/zlfmfk https://perma.cc/kj73-l34b https://www.fda.gov.tw/tc/sitelist.aspx?sid=10060 https://perma.cc/7jeq-ysm3 https://www.fda.gov.tw/tc/sitelist.aspx?sid=9988 indiana health law review [vol. 22:63 84 have developed a system to oversee the traceability systems implemented by distributors and manufacturers. 179 the track and trace regulations apply to medicinal products license holders (“license holders”) and distributors engaged in wholesaling (“distributors”). 180 license holders must report the following information: 1. pharmaceutical manufacturing or importing information;181 2. active ingredient information;182 and 3. transactional information. 183 license holders must submit information electronically by the 10th of the month following the month of reporting. 184 distributors must report the following information:185 1. information regarding product supplier;186 and 2. information regarding flow of medicinal product. 187 distributors must submit information electronically by the 10th of the month following the month of reporting. 188 license holders and distributors must keep relevant information in their records “for at least five years from the date of manufacturing, import, export or supply.”189 companies must comply with requests for data initiated by relevant authorities.190 of note, mr. yang po-wen, a taiwanese expert in this area, mentioned that drug packages in taiwan employ barcodes, and while the gs1-128 is widely used in taiwan, its use is not mandated. 191 the hesitance to require gs1-128 standards stems from concerns that adopting these standards may lead to higher costs and potentially deter pharmaceutical companies from entering taiwan’s ————————————————————————————— 179. id. 180. id. art. 3. 181. id. art. 4 (“(1) name of the medicinal product, approved number, indication, dosage form, ingredients, company name, name and address of manufacturer recorded on the medicinal product license. (2) bar code or other symbol for identification purpose. (3) batch number. (4) quantity. (5) manufacture date. (6) expiry date or shelf life. (7) declared import date of medicinal product.”). 182. id. (“(1) the source of active ingredient. (2) manufacturer’s name, address and nationality.”). 183. id. art. 4. (“(1) receptor’s name, address, contact person and telephone number. (2) name of medicinal product. (3) batch number. (4) quantity. (5) manufacture date. (6) expiry date or shelf life. (7) delivery date.”). 184. id. art. 4. 185. id. art. 5. 186. id. (“(1) name, address, contact person and telephone number of supplier. (2) name of the medicinal product and approved number on the medicinal product license. (3) batch number. (4) quantity. (5) manufacture date. (6) expiry date or shelf life. (7) delivery date.”). 187. id. (“(1) name, address, contact person and telephone number of receptor. (2) name of the medicinal product and product license number. (3) batch number. (4) quantity. (5) manufacture date. (6) expiry date or shelf life. (7) delivery date.”). 188. id. 189. id. art. 6. 190. id. art. 7. 191. huang, supra note 172. 2025] towards global harmonization 85 market. 192 d. penalties under the act, relevant authorities have the authority to confiscate or destroy counterfeit items. 193 in cases where counterfeit or substandard drugs, or faulty medical devices are sold, relevant government agencies will publish “the name, address, and the responsible person of the firm or the business, the name of the drugs involved, and the details of violation.” 194 government agencies can also suspend business operations and revoke licenses. 195 seized counterfeit or illegal drugs are subject to confiscation and destruction. 196 misbranded drugs or defective medical devices that are still useable can be modified to conform to specifications.197 in specified circumstances relating to medicaments, “its manufacturer or importer shall immediately notify medical care institutions, pharmacies, and pharmaceutical firms, and within a prescribed time limit, shall recall the medicament in question from the market and dispose of it together with its stock of the medicament.” 198 finally, there are stiff criminal consequences for manufactures who import counterfeit drugs or prohibited drugs.199 e. conclusion of taiwan’s regime overall, the primary objective of taiwan’s pharmaceutical track and trace system, much like the dscsa and eu regime, is to safeguard the pharmaceutical supply chain’s security and reliability while preserving public health. the act provides the foundation for the management of pharmaceutical affairs, and with its regulatory base, participation of government, and participation of industry, the system is relatively successful in protecting public health. the taiwan government has built robust system infrastructures for statistical analysis, enabling the tfda and health bureaus to identify and address potential issues proactively. this comprehensive approach to pharmaceutical supply chain management ultimately protects public health and promotes confidence in the quality and safety of medications available to consumers. this system, however, does have weaknesses. for example, standards for ————————————————————————————— 192. id. 193. 藥事法 [pharmaceutical affairs act], art. 77 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2018), https://law.moj.gov.tw/eng/ lawclass/lawall.aspx?pcode=l0030001 [https://perma.cc/7t7r-qa83]. 194. id. art. 78. 195. id. 196. id. art. 79. 197. id. 198. id. art. 80. 199. id. art. 82. https://perma.cc/7t7r-qa83 https://law.moj.gov.tw/eng indiana health law review [vol. 22:63 86 barcodes and serialization are not consistent, which introduces inefficiencies and pain points for stakeholders. 200 hesitance to use international standards such as gs1-128 could also prevent taiwan businesses from full participation in international pharmaceutical trade. these inconsistencies, however, could be solved with a unified regional or international framework for track and trace of pharmaceuticals. more regional international participation and adherence to regional or international standards could encourage the government and industry in taiwan to adopt a more consistent serialization and barcode standards. taiwan, like other countries, faces challenges related to counterfeit drugs. 201 a recent case involving rosuvastatin, which was mixed with another drug and introduced into the market, highlights this issue. 202 despite the government’s comprehensive response to the incident, the counterfeit drugs were still able to infiltrate the taiwanese market. this underscores the importance of continued vigilance by the taiwanese government to mitigate the risks of introducing counterfeit pharmaceuticals into its national market. one important step could be the participation in an international, cooperative system of tracking and tracing pharmaceuticals. there are clear parallels with the dscsa, the european falsified medicines directive, and the pharmaceutical regulations in place in taiwan. each of these regulatory frameworks mandates stringent tracking and verification systems to ensure the authenticity and safety of medicinal products within their respective supply chains. despite these similarities, there are missing elements, discussed below. ————————————————————————————— 200. taiwan center for drug evaluation, expert meeting minutes taiwan pharmaceutical epedigree system specification and application plan, (july 16, 2014), http://www.tpmma.org.tw/epaper/upload_files/%e5%8f%b0%e7%81%a3%e8%97%a5%e 5%93%81%e5%b1%a5%e6%ad%b7%e5%b9%b3%e5%8f%b0%e7%b3%bb%e7%b5 %b1%e8%a6%8f%e6%a0%bc%e8%88%87%e6%87%89%e7%94%a8%e8%a6%8f%e 5%8a%83-%e6%9c%83%e8%ad%b0%e7%b4%80%e9%8c%84.pdf [https://perma.cc/ 5dza-uzg5] (noting concerns about the feasibility of implementing serialization in taiwan, discussing which country’s serialization system taiwan should adopt, and questioning whether it is possible to connect to those systems). 201. see, e.g., lee i-chia, batch of lipid-lowering drug faked: astrazeneca, taipei times (mar. 06, 2017), https://www.taipeitimes.com/news/taiwan/archives/2017/03/06/2003666236 [https://perma.cc/psb9-7ane]. 202. id. https://perma.cc/psb9-7ane https://www.taipeitimes.com/news/taiwan/archives/2017/03/06/2003666236 https://perma.cc http://www.tpmma.org.tw/epaper/upload_files/%e5%8f%b0%e7%81%a3%e8%97%a5%e 2025] towards global harmonization 87 v. a worldwide unified, interoperable, and digital platform for pharmaceutical track and trace 203 this article recommends that national track and trace systems should be interoperable with regional and global systems to ensure the full safety of the pharmaceutical supply chain. therefore, this article advocates for a worldwide unified, interoperable, and digital platform for pharmaceutical track and trace. this digital platform would ideally be independent of national platforms, but national systems should be interoperable with the digital platform and be capable of interfacing with other member states. such interoperability would entail the establishment of standardized data formats, communication protocols, and compliance requirements that facilitate information exchange between member states. by promoting interoperability, countries can efficiently share crucial information, while maintaining the independence of their own systems. the author has synthesized these three systems and created a proposed system, called the captrace system below. a. need for transnational cooperation one government expert from the tfda has expressed the need for transnational cooperation with regard to pharmaceutical track and trace. 204 in addition, cphi’s asean pharma 2020 report revealed a key finding that, “the regional industry now favours introducing large scale counter measures, supply chain tracking and serialization. in fact, an overwhelming 93% of the industry experts surveyed believe that the southeast asian market would significantly benefit from a track and trace-style scheme to reduce the space for counterfeiting in the region.” 205 these kinds of sentiments underscore the ————————————————————————————— 203. as noted in the author biographical section at the beginning of this article, the author has utilized chatgpt to create or assist in the creation of content included throughout this article. for this section in particular, the author utilized significant assistance from chatgpt to create or assist in the creation of content, especially with respect to synthesizing the elements of the captrace agreement. prompts included various stems that included the author’s proposed language followed by significant copy editing, reversion, and further additions by the author. the author used the assistance of chatgpt to synthesize elements of the dscsa, the eu directive, the taiwan regulatory regime, and other ideas into a unique approach for the world under the captrace agreement. this included the assistance of chatgpt to add detail to text, expand on ideas, and create novel ways of expressing ideas. as such, chatgpt assisted in drafting significant portions of this section under the guidance and editing of the author. this iterative process of interacting with chatgpt (collaboration, synthesis, modification, reversion, augmenting, repeating) proved to be invaluable for the content in this section, providing a higher quality end product and superior content for the reader. for a discussion on best practices for disclosing the use of ai tools, see generally mark l. shope, best practices for disclosure and citation when using artificial intelligence tools, 112 geo. l.j. online 1 (2023). 204. huang, supra note 172. 205. cphiinsights, asean pharma report: opportunities & threats 2020 and beyond 7 (mar. 2020) (available at https://www.medicpresents.com/medicfiles/9746_aseanreport-rep-2020-vd-003.pdf [https://perma.cc/d9xs-hxhr]). https://perma.cc/d9xs-hxhr https://www.medicpresents.com/medicfiles/9746_asean indiana health law review [vol. 22:63 88 growing consensus within the industry for a unified track and trace regime. asean has one regional project that appears promising under the recently published asean pharmaceutical regulatory policy. the asean pharmaceutical regulatory policy states: it has been recognised, that in order to provide a structure and instruments to realise the free flow of safe, efficacious and quality pharmaceuticals in the region, to facilitate access to needed pharmaceuticals and eliminate substandard and falsified products, it is important to adopt first a common asean pharmaceutical regulatory policy (aprp). the aprp will include the principles and other key features serving as a common basis for coordination and development of the asean pharmaceutical regulatory framework (aprf) and will be followed by the development of legal instruments when required to implement such policy. the aprp will provide guidance for the development of comprehensive set of initiatives to support the integration of the market in the pharmaceutical sector. 206 asean, however, is limited in international scope. one vehicle to facilitate transnational track and trace cooperation on a world level would be a cooperative agreement on pharmaceutical track and trace (“captrace agreement”). 207 the captrace agreement would provide for a unified, comprehensive system for tracking and tracing pharmaceutical products. the captrace agreement would be complementary to other trade and cooperative arrangements. a working group could be developed under the pharmaceutical inspection co-operation scheme (pic/s) to explore the captrace agreement. 208 ————————————————————————————— 206. ass’n of se. asian nations [asean], asean pharmaceutical regulatory policy, at 2 (mar. 15, 2022), https://asean.org/wp-content/uploads/2022/08/final-text-aprp-adoptedaem-and-ahmm.pdf [https://perma.cc/bdm6-aecx]. 207. similar in spirit to the framework agreement on facilitation of cross-border paperless trade in asia and the pacific. framework agreement on facilitation of cross-border paperless trade in asia and the pacific, opened for signature aug. 23, 2016 (entered into force feb 20, 2021) https://repository.unescap.org/bitstream/handle/20.500.12870/1048/escap-2019-pbframework-agreement-facilitation-cross-border-paperless-trade.pdf?sequence=1&isallowed=y [https://perma.cc/sz7b-3pfx]; see also status of the framework agreement on facilitation of cross-border paperless trade in asia and the pacific, un treaty collection (sept. 22, 2024 4:13 pm), https://treaties.un.org/pages/viewdetails.aspx?src=treaty&mtdsg_no=x-20& chapter=10&clang=_en [https://perma.cc/b5h9-ngvm]. 208. pharmaceutical inspection conventional–pharmaceutical inspection cooperation scheme [pic/s], introduction, https://picscheme.org/en/about [https://perma. cc/p9pn-dvpa] (last visited oct. 31, 2024) (“the pharmaceutical inspection co-operation scheme (pic/s) is a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (gmp) of medicinal products for human or veterinary use. it is open to any authority having a comparable gmp inspection system. pic/s presently comprises 54 participating authorities coming from all over the world (europe, africa, america, asia and australasia).”). https://perma https://picscheme.org/en/about https://perma.cc/b5h9-ngvm https://treaties.un.org/pages/viewdetails.aspx?src=treaty&mtdsg_no=x-20 https://perma.cc/sz7b-3pfx https://repository.unescap.org/bitstream/handle/20.500.12870/1048/escap-2019-pb https://perma.cc/bdm6-aecx https://asean.org/wp-content/uploads/2022/08/final-text-aprp-adopted 2025] towards global harmonization 89 the framework for the captrace agreement should find inspiration from the various track and trace systems in the region and around the world, including the dscsa, eu falsified medicines directive, and the track and trace system in taiwan. a worldwide system that is similar to the comprehensive dscsa or eu falsified medicines directive would facilitate integration into relevant pharmaceutical markets beyond europe and north america. vi. captrace proposal a. licensing authorized trading partners the proposed captrace agreement should be designed to establish a robust framework for the licensing and regulation of authorized trading partners within member states. the activities of authorized trading partners relating to manufacture, export, import, distribution, and related movement of covered products should comply with gmp and gdp in order to uphold the highest quality and safety standards in the pharmaceutical supply chain. ideally, a written confirmation or standard authorization from the member state would be exchanged or made available on a transparent platform for easy inspection, noting that a particular trading partner is an authorized trading partner and that member state standards have been met with regard to a covered product. b. auditing authorized trading partners under the captrace agreement, an entity seeking authorization to operate as a trading partner would be subject to a comprehensive member state led auditing process, which would evaluate its compliance with the established gmp and gdp guidelines and agreed-upon standards of member states. this process could be conducted by a national-level agency, intergovernmental body, or qualified third-party auditing organization, ensuring consistency in the evaluation. the authorized trading partner should be periodically subjected to audits in order to maintain its accreditation status. noted above, taiwanese law provides for government authorities to “send personnel overseas to inspect . . . foreign manufacturing factories on a periodical basis or as necessary.” 209 reciprocal agreements could be included in the captrace agreement to allow for routine inspections by member states like the one provided for under taiwanese law. ————————————————————————————— 209. 藥事法 [pharmaceutical affairs act], art. 57 fawubu fagui ziliaoku [taiwan ministry of justice laws and regulations database] (2018), https://law.moj.gov.tw/eng/ lawclass/lawall.aspx?pcode=l0030001 [https://perma.cc/7t7r-qa83]. https://perma.cc/7t7r-qa83 https://law.moj.gov.tw/eng indiana health law review [vol. 22:63 90 c. reporting requirements the captrace agreement should mandate that authorized trading partners promptly report any suspicious or counterfeit pharmaceutical products to a designated competent oversight authority. this authority would be responsible for investigating the reported cases and informing other member states. d. trade only within authorized network the captrace agreement could stipulate that authorized trading partners can only engage in business transactions with other similarly authorized entities. this provision would be intended to create a closed network of authorized trading partners, thereby minimizing the chances of counterfeit products infiltrating the pharmaceutical supply chain. this authorized trading partner network would require an exchange of transaction information, transaction history, and transaction statements, like that under the dscsa. the “exchange” of this information would be required to be recorded in “real-time.” implementing a “real-time” information exchange system would offer numerous advantages for the authorized trading partners and competent oversight authorities within member states, including enhanced traceability, rapid response to suspected counterfeit products, improved efficiency in product recalls, enhanced transparency and accountability, and simplified auditing and compliance monitoring. e. unique identifiers the proposed captrace agreement envisions the implementation of a harmonized system of unique identifiers for pharmaceutical products among member states, aimed at enhancing the traceability and verification of product authenticity. this system would involve the assignment of a distinct identifier to each individual product at the smallest level possible, which would be registered in a centralized database accessible to all authorized trading partners. unique identifiers for products should adhere to internationally recognized standards, ensuring consistency and interoperability across different systems. f. multiple anti-tampering mechanisms in addition to the unique identifier, pharmaceutical packaging should be designed to incorporate multiple anti-tampering mechanisms that would enable the detection of any unauthorized access to or manipulation of the product. these anti-tampering mechanisms would serve as a necessary added layer of protection against potential counterfeit products entering the pharmaceutical supply chain. these anti-tampering mechanisms and unique identifiers would be unique to captrace agreement member states but would also be 2025] towards global harmonization 91 verifiable by other jurisdictions. g. verification requirement as part of their responsibilities under the captrace agreement, authorized trading partners would be required to verify the authenticity of the unique identifiers assigned to the pharmaceutical products they handle. this process would involve cross-referencing the identifier with a centralized database (to be created by member states) to confirm that a covered product is genuine and has been sourced from an authorized trading partner. in the event of any discrepancies or concerns, the authorized trading partner would be obligated to report the issue to the relevant competent oversight authority for further investigation. this authority would be responsible for investigating the reported issue and, if necessary, take appropriate actions to inform other member states. h. routine inspection of pharmaceutical products authorized trading partners would be expected to routinely inspect the pharmaceutical products in their possession or control for signs of irregularity. if any evidence of irregularity is discovered, the trading partner must immediately notify the competent oversight authority for further handling, including communicating with member states. authorized trading partners would also be expected to keep inspection records for a defined period of time. i. track and trace platform drawing inspiration from the dscsa, eu directive, and taiwan regulatory approaches, the proposed captrace agreement advocates for the implementation of an advanced, interoperable electronic tracking and tracing system for pharmaceutical products. this system, which would be modeled after the requirements under various systems (but taking significant inspiration from the dscsa, eu directive, and taiwan regulatory approaches), is intended to bolster the security and integrity of the pharmaceutical supply chain among member states, while also facilitating swift and efficient responses to irregularities. to achieve these objectives, the captrace agreement would call for (at least) the following: secure and interoperable data exchange, inclusion of product identifiers, product verification systems, recall and investigation mechanisms, and transaction information retention protocols. 210 this platform would operate independently from national platforms; however, national systems should be compatible with this digital platform and capable of interacting with other member states through apis or other electronic data ————————————————————————————— 210. for the dscsa approach, see 21 u.s.c. § 360eee–1(g) (enhanced drug distribution security). indiana health law review [vol. 22:63 92 exchange protocols. through fostering interoperability, countries can effectively share vital information while preserving the autonomy of their individual systems. j. driven by data under this framework and taking inspiration from the taiwan experience, oversight authorities could leverage data-driven and automated auditing and oversight processes, facilitating the development of more sophisticated and efficient auditing and oversight methods. relevant authorities could identify patterns, trends, and anomalies that may signal potential risks or noncompliance issues. relevant authorities could quickly analyse large volumes of data and flag potential issues for further investigation. this allows oversight authorities to allocate their resources more effectively and cover a broader scope of the pharmaceutical supply chain. data-driven and automatic auditing and oversight methods can be continually refined and adapted based on new information, evolving regulations, or changes in the pharmaceutical supply chain landscape. the experience gained from taiwan regarding its use of data from multiple sources could be instructive to this data driven model. vii. conclusions by implementing the captrace agreement, member states could enhance the integrity of their pharmaceutical supply chains, foster greater transparency, and ultimately, ensure the safety and efficacy of the pharmaceutical products being distributed to its citizens. only addressing the issue of pharmaceutical supply chain safety at a national level is incomplete, as the complex and global nature of the pharmaceutical supply chain necessitates a more comprehensive, unified approach. supply chains often span multiple countries, and involve numerous manufacturers, distributors, and trading partners, each subject to different regulatory frameworks, oversight mechanisms, and industry standards. by fostering collaboration and harmonizing robust tracking and tracing systems across borders, stakeholders can work together to effectively address the challenges posed by counterfeit and substandard products, as well as other supply chain disruptions. this cooperation ultimately protects public health and ensures the availability of safe pharmaceutical products for end consumers when those products are needed most. structure bookmarks owards lobal armonizationomparative nalysis of aiwans harmaceutical rack and race ystem is the use of artificial intelligence in the femtech industry feminist? the bioethical and legal dilemmas in the femtech industry from a feminist perspective is the use of artificial intelligence in the femtech industry feminist? the bioethical and legal dilemmas in the femtech industry from a feminist perspective adi youcht * abstract this article offers another ‘take’ on the lively and current discussions being held on the outline of bioethical principles and legal regulation of artificial intelligence technologies, in the areas of medicine and health. it examines to what extent women’s interests and feminist agendas are taken into account in these discussions. for this purpose, the article focuses on the femtech industry. it is specifically interested in ai-based technologies in the area of medicine and health that targets women and is focused on female issues. by doing so, the article studies the crossroads between ai-based technologies’ regulation, devices in favor of medicine and health, and technologies targeted for women. based on empirical illustrations, and in light of the current positive law, the article explores the bioethical and legal dilemmas in the femtech industry from a feminist perspective. it specifically asks whether the use of ai in the femtech industry can be considered feminist. in other words, it explores whether the technologies that aim to treat women’s health, address new challenges facing feminist ethics or social philosophy, or if they simply raise old bioethical questions in relation to new technologies. the article looks at the advantages, alongside the challenges, of ai-based femtech devices from a feminist perspective. additionally, it sets the grounds for a feminist regulatory and ethical policy, with respect to ai-based medical devices. table of contents i. introduction ii. artificial intelligence & the femtech industry iii. the focus of femtech products: diseases, fertility, and sexuality a. diseases b. fertility c. sexuality iv. raising funds for femtech industry and its challenges v. research questions, approach, and method ————————————————————————————— ∗ lecturer (assistant professor), haim striks faculty of law at the college of management academic studies. i extend my thanks to glenn cohen and participants in the oxford global health and bioethics international conference for their helpful comments and ideas, and for their feedback on the drafts of this article. i wish to thank the research authority fund of the college of management academic studies, rishon le’zion, israel for their financial support of this research. indiana health law review [vol. 22:93 94 vi. the opportunities and challenges of ai-based femtech products a. the problem of bias b. constructing stereotypical social perceptions about women c. challenging privacy vii. toward feminist regulation of ai-based medical devices: bioethical principles, regulatory regime & legal accountability a. social justice and fairness b. autonomy, transparency, and explainability c. non-maleficence d. responsibility and accountability e. the comparative perspective viii. summary and conclusions i. introduction i’m increasingly inclined to think that there should be some regulatory oversight, maybe at the national and international level, just to make sure that we don’t do something very foolish. [i mean] with artificial intelligence we’re summoning the demon.1 [elon musk -] the real question is, when will we draft an artificial intelligence bill of rights? what will that consist of? and who will get to decide that? 2 [gray scott -] as can be evidenced in elon musk’s comment and gray scott’s question, the topic of artificial intelligence-based technologies’ regulation and its connection to human rights protection have been, for quite a long time, a matter of interest for governments, industries, and scholars. 3 this article focuses on a narrow aspect of the topic of artificial intelligence (ai) regulation and its protection of human rights – that is the protection of women’s interests and the preservation of feminist principles – in the course of regulation of ai. as ————————————————————————————— 1. samuel gibbs, elon musk: artificial intelligence is our biggest existential threat, the guardian (oct. 27, 2014) (emphasis added), https://www.theguardian.com/technology/ 2014/oct/27/elon-musk-artificial-intelligence-ai-biggest-existentialthreat[https://perma.cc/y8kb-22c9]. 2. gray scott, gray scott quotes, brainyquote, https://www.brainyquote.com/quotes/ gray_scott_776538 [https://perma.cc/4kle-hhq9] (last visited oct. 20, 2024). 3. see, e.g., scott j. shackelford, et al., should we trust a black box to safeguard human rights? a comparative analysis of ai governance, 26 ucla j. int’l l. & foreign affs. 35, 37–39 (2022); kimberly a. houser, symposium: artificial rights? artificial intelligence and the struggle between good and evil, 60 washburn l.j. 475, 475–76 (2021); david s. rubenstein, acquiring ethical ai, 73 fla. l. rev. 747. 747, 749–57 (2021). https://perma.cc/4kle-hhq9 https://www.brainyquote.com/quotes https://www.theguardian.com/technology 2025] the use of artificial intelligence 95 melinda gates stated: “if we don’t get women […] at the table – real technologies doing the real work – we will bias systems. trying to reverse that a decade or two from now will be so much more difficult, if not close to impossible.”4 this article is specifically interested in ai-based technologies in the area of medicine that targets women and focuses on female issues. the crossroads between regulation of ai-based technologies, medical and health devices, and technologies that target women, have rarely been studied. 5 while there is a digital revolution happening in the field of medical devices, medical devices have historically been less regulated than their drug and biologic counterparts. 6 the fda proposed a new framework for review of the ongoing artificial intelligence algorithm changes for device software. 7 moreover, cutting-edge literature is preoccupied with the question: what should a robust regulatory regime for medical devices look like in the coming years? 8 this question has yet to be studied with respect to technological solutions and innovations addressing women’s issues. based on empirical illustrations, and in light of the current positive law, i offer an initial discussion on the bioethical and legal dilemmas in the femtech industry from a feminist perspective. i specifically ask whether the use of ai in the femtech industry can be considered feminist. in other words, i explore whether the technologies that aim to take care of women’s health, address new challenges facing feminist ethics or social philosophy. another option is that these technologies simply raise old bioethical questions in relation to new technologies. this article explores the advantages, alongside the challenges, of ai-based femtech devices from a feminist perspective. i set the grounds for a feminist ————————————————————————————— 4. see jessi hempel, melinda gates and fei-fei li want to liberate ai from “guys with hoodies”, wired-backchannel (may 4, 2017), https://www.wired.com/2017/05/melindagates-and-fei-fei-li-want-to-liberate-ai-from-guys-with-hoodies/ [https://perma.cc/6eramwr3]. 5. on the regulation outlines of ai-based technologies in the medical and health arena, see generally nicolas terry, of regulating healthcare ai and robots, 18 yale j. health pol’y l. & ethics 133 (2019); sara gerke, et al., ethical and legal challenges of artificial intelligence-driven healthcare, in artificial intelligence in healthcare 295 (adam bohr & kaveh memarzadeh eds., 2020); jessa boubker, when medical devices have a mind of their own: the challenges of regulating artificial intelligence, 47 am. j.l. & med. 427 (2021); catherine m. sharkey & kevin m.k. fodouop, ai and the regulatory paradigm shift at the fda, 72 duke l.j. online 86 (2022). for exceptional writing on the ethical challenges relating to technologies that target women, see bethany a. corbin, digital micro-aggressions and discrimination: femtech and the “othering” of women, 44 nova l. rev. 337 (2020); leah r. fowler & michael r. ulrich, femtechnodystopia, 75 stan. l. rev. 1233 (2023); michele e. gilman, feminism, privacy and law in cyberspace, in the oxford handbook of feminism and law in the united states 552 (deborah brake et al eds., 2023). 6. wendy netter epstein, disrupting the market for ineffective medical devices, in the future of medical device regulation: innovation and protection 179 (i. glenn cohen et al. eds., 2022). 7. id. at 179–80. 8. id. https://perma.cc/6era https://www.wired.com/2017/05/melinda indiana health law review [vol. 22:93 96 regulatory and ethical policy, with respect to ai-based medical devices. the next second section of this article introduces the entrance of ai-based technologies to the femtech industry. the third section discusses and exemplifies the main areas of interest of the femtech industry. the forth section presents the topic of raising funds for the femtech industry, and its challenges. the fifth section introduces the research questions, approach, and method. the sixth section studies the opportunities and challenges of applying ai-based technologies in the femtech industry from a feminist perspective. the seventh section sets an initial normative horizon for feminist regulation of ai-based medical technologies. the eighth section offers some concluding remarks. ii. artificial intelligence & the femtech industry the term “femtech” was first coined in 2016 by entrepreneur ida tin. 9 femtech is described as any digital technology in the female health sector. 10 the industry includes, inter alia, wearable ai, mobile applications, diagnostic tools, or monitoring software for managing women’s health. the issues to be considered in women’s health include, among others, fertility, reproduction, menstruation, diseases typically recognized as women’s diseases (e.g., breast or cervical cancer), mental health, and sexuality. ever since the term femtech was coined, its global market has grown to become a sector of its own right. in 2022, the global medtech market reached 646.7 billion us dollars. 11 femtech companies accounted for 28 billion us dollars in 2024.12 the sector has over 1800 companies and is still growing. 13 however, it is not receiving the recognition it should, considering the fact that women make up over fifty percent of the general population. 14 nevertheless, it seems that the femtech sector is rapidly increasing, and it has been estimated that it will reach 766.7 billion us dollars by 2025. 15 ————————————————————————————— 9. see marija butkovic, top 100 women in femtech and health tech, medium (apr. 13, 2019), https://medium.com/women-of-wearables/top-100-women-in-fem-tech-and-health-tech34eccf021053 [https://perma.cc/w43s-5n2r]. 10. corbin, supra note 5, at 338–39. 11. see 2023 – a maintenance phase of the pandemic, unless covid rears its ugly head again, med. buyer (dec. 27, 2022), https://www.medicalbuyer.co.in/2023-a-maintenancephase-of-the-pandemic-unless-covid-rears-its-ugly-head-again/ [https://perma.cc/x8ej-92wr]. 12. see femtech: what is femtech?, dealroom.co, https://dealroom.co/guides/femtech#:~: text=femtech%20companies %20are%20now%20worth%20%2428%20billion%20in%202023 [https://perma.cc/xd5m-a8h9] (last visited oct. 20, 2024). 13. see ariela karmel, israel is poised to lead the way in femtech, but challenges remain in realizing full potential, ctech by calcalist (june 7, 2023), https://www.calcalistech. com/ctechnews/article/hjggw0ti2 [https://perma.cc/m6jd-4jk8]. 14. see corbin, supra note 5, at 342–47. 15. medical buyer, supra note 11. https://perma.cc/m6jd-4jk8 https://www.calcalistech https://perma.cc/xd5m-a8h9 https://dealroom.co/guides/femtech https://perma.cc/x8ej-92wr https://www.medicalbuyer.co.in/2023-a-maintenance https://perma.cc/w43s-5n2r https://medium.com/women-of-wearables/top-100-women-in-fem-tech-and-health-tech 2025] the use of artificial intelligence 97 in recent years the idiomatic phrase, “artificial intelligence,” has described machines, or computers, whose work is perceived as smart, sophisticated, or human. 16 the various trials to define “artificial intelligence” can be divided into two major definitions – technological definitions and functional definitions. the technological definitions usually focus on the basic abilities of the aibased tools, and they are mostly identified with the areas of data science and machine learning. while data science focuses on producing information and deriving insights from existing databases, machine learning emphasizes the ability of machines to learn and improve the implementation of activity based on data, examples and acquired experience. both data science and machine learning are interested in the technological essence of collecting and producing data, in order to fulfill a given algorithmic task. functional definitions of artificial intelligence, on the other hand, focus on the comparison to human thinking or human concluding processes. 17 for the purposes of this article, the area of artificial intelligence will be identified as a general name for all technological developments that enable decision-making, produce forecasts, or any other activity by computers working at a high level of independence that imitate or substitute human intelligence. iii. the focus of femtech products: diseases, fertility, and sexuality most ai-based products in the femtech industry can be divided into three areas of expertise. the first is concerned with women’s illness. this refers to all processes of detection, diagnosis, and treatment of diseases and conditions that affect women’s health. the second is focused on fertility and reproduction – namely the ability to conceive children. the third area of femtech products is ————————————————————————————— 16. world health organization guidance, ethics and governance of artificial intelligence for health 4 (2021). 17. the oecd’s definition of ai focuses on its functional abilities. according to this definition, an ai system is a machine-based system that can make predictions, recommendations, or decisions, for a given set of human-defined objectives that influence real or virtual environments. ai systems, thus, are designed to operate with varying levels of autonomy. see oecd council, recommendation of the council on artificial intelligence 7 (2019), https://legalinstruments.oecd.org/en/instruments/oecd-legal-0449 [https://perma.cc/k82fvb34]. a similar definition was included in the european draft act on artificial intelligence (ai) and the canadian draft of ai legislation. see eur. consult. ass., proposal for a regulation of the european parliament and of the council laying down harmonised rules on artificial intelligence (artificial intelligence act) and amending certain union legislative acts, doc. no. 8115/21 (2024) [hereinafter proposal for european council regulation]; house of commons of canada, bill c-27, an act to enact the consumer privacy protection act, the personal information and data protection tribunal act and the artificial intelligence and data act, in order to make consequential and related amendments to other acts, 3 (2022) https://www.parl.ca/content/bills/441/government/c-27/c-27_1/c-27_1.pdf [https:// perma.cc/fbl2-hxn2]. https://www.parl.ca/content/bills/441/government/c-27/c-27_1/c-27_1.pdf https://perma.cc/k82f https://legalinstruments.oecd.org/en/instruments/oecd-legal-0449 indiana health law review [vol. 22:93 98 connected to female sexuality. this endeavors to advance female sexual wellbeing and enables women to make positive choices about their own sexual lives. for purposes of illustration and later discussion, a few representative and non-exhaustive examples of products in the abovementioned areas of expertise will be provided here. a. diseases ai technologies improve the detection, diagnostics, and treatment of female related illnesses. an example of a typical ai-based product, which endeavors to prevent and handle well-known female diseases, was developed by the nevia start-up. 18 nevia works at detecting female diseases, based on an ai analysis of vaginal discharge. 19 due to the existence of various proteins in vaginal discharge, the changing rate of each protein is a good predictor of different kinds of diseases, starting from cervical and ovarian cancer, through ovulation problems, to endometriosis. the company developed smart pads, which are analyzed by an ai algorithm, in order to detect female diseases. 20 these smart pads are intended to be marketed as a shelf product, like home pregnancy detection tests. the company’s algorithm is based on analysis of a unique israeli bio-bank, the first of its kind. 21 vaginal discharge samples have been deposited since 2019.22 in an innovative fashion, nevia’s ai algorithm takes into account vaginal discharge, as a source of medical knowledge. to date, medical research has barely treated vaginal discharge as a source of knowledge. 23 when dr. inbal zafir-lavie, one of nevia’s founders, was asked why the medical research had not previously treated vaginal discharge as a source of knowledge, she answered: when i stand in front of men and talk to them about vaginal discharge […] i frequently need to explain to them what i mean by vaginal discharge. they do not completely understand. i tell them that it is liquid, similar to tears. however, if one is not aware of a material, how can we expect them to study it? […] it is that simple. […] men can study […] urine, […] blood, spittle, and sperm, but vaginal discharge is a red rag which they prefer to disregard.24 ————————————————————————————— 18. on the nevia start-up, see the new way for early detection, nevia, https://www. nevia.bio/ [https://perma.cc/h7zr-z9qh] (last visited sept. 22, 2024). 19. id. 20. roni dori, vaginal discharge is a treasure of information, calcalist (nov. 4, 2021), https://newmedia.calcalist.co.il/magazine-04-11-21/m01.html [https://perma.cc/6pvd-hh5z]. 21. id. 22. id. 23. id. 24. id. https://perma.cc/6pvd-hh5z https://newmedia.calcalist.co.il/magazine-04-11-21/m01.html https://perma.cc/h7zr-z9qh https://www 2025] the use of artificial intelligence 99 nevia’s algorithm is designed, inter alia, to detect endometriosis. 25 its symptoms include chronic pain, difficulties in getting pregnant and continuous bleeding during a woman’s period. 26 though one out of ten fertile women suffers from endometriosis, the reported average diagnosis time of this disease is ten years. 27 the accepted explanation for this unfortunate fact is physicians’ ignorance.28 training nevia’s ai algorithm on a new source of medical knowledge – namely, vaginal discharge – aims to enable the detection of endometriosis, a disease from which women have traditionally suffered due to underdiagnosing and a lack of needed treatment. 29 tulipon also developed an innovative tampon that monitors vaginal discharge and diagnoses diseases, based on biomarkers in the woman’s menstruation. 30 enthusiastically describing tulipon’s development, its founder, hila shaviv, stated: i consider myself a female knight, fighting for gender parity by developing new technologies that address women’s health and wellbeing. 31 (emphasis added) another area of ai-based products in the femtech industry focuses on fertility and women’s reproduction. the following section is dedicated to illustrating this market niche. b. fertility a rich variety of ai applications in the area of female fertility and reproduction are presently under development or marketing. these include, inter alia, the assessment of ovarian reserve parameters, the prediction of live-birth occurrence, improved matching of egg donors with receipts for third-party reproduction, enhanced pre-implantation genetic testing (pgt), etc. 32 an ————————————————————————————— 25. see the new way for early detection, supra note 18. 26. dori, supra note 20. 27. id. 28. id. 29. id. 30. on the tulipon start-up, see tulipon: empowering women with home period diagnostics, tulipon, https://www.tulipon.com/ [https://perma.cc/f4a7-pqzy] (last visited sept. 19, 2024). similarly, mobile odt is an israeli femtech company that aims to create a revolution in the area of cervical cancer, which is the fourth-ranked cancer in the world. the company developed a smartphone-based technology using ai, in order to perform early detection of cervical cancer. see high technology for women’s health, mobileodt, https://www. mobileodt.com/ [https://perma.cc/hp3f-kjtb] (last visited sept. 22, 2024). 31. interview with eng. hilla shaviv, inventor, founder and ceo, gals bio ltd., femtech analytics (jan. 18, 2022), https://www.femtech.health/post/interview-with-eng-hilla-shavivinventor-founder-and-ceo-gals-bio-ltd [https://perma.cc/da3b-2mtd]. 32. see sivan tamir, artificial intelligence in human reproduction: charting the ethical debate over ai in ivf, 3 ai & ethics 947, 948 (2023). https://perma.cc/da3b-2mtd https://www.femtech.health/post/interview-with-eng-hilla-shaviv https://perma.cc/hp3f-kjtb https://mobileodt.com https://www https://perma.cc/f4a7-pqzy https://www.tulipon.com indiana health law review [vol. 22:93 100 additional non-exhaustive example of the use of ai in gynecology is the potential integration of ai in ivf treatments. 33 the start-up that claims to be the first one that initiated the introduction of ai into the ivf industry is aivf. 34 aivf offers a new technology that aims to simplify the ivf embryo selection process, by providing clinicians and embryologists with a fully automated ai-based decision support tool. 35 the company focuses on the embryo selection stage, in which the decision is made concerning which embryos have the best chances to develop into a full pregnancy. 36 as embryologist and aivf ceo, daniella gilboa, puts it: the one million dollar question that all ivf units ask is ‘which embryo has the best chance to turn into pregnancy.’ you stand in front of the embryos and you need to pick ‘the one’. the selection is made, based on years of experience of the embryologist and the physician. they see the embryos in the computer, diagnose them, look at their rate of division […] and try to grade each one of them. however, this grade is subjective and not based on data.37 aivf designed its algorithm by studying millions of embryos, in order to be able to recommend which embryo is the best candidate for selection. 38 an additional example of a product in the area of fertility and reproduction is the breakthrough for women’s lives of self-scan ultrasound devices for aibased and remote clinical diagnosis. 39 the home ultrasound system has real potential to provide doctors with better control of the prenatal path of care. for the patient, it could significantly reduce anxiety during pregnancy, thanks to the continuity of care between visits. the home ultrasound system gives the patients a better pregnancy experience and helps the non-pregnant partner to feel more involved. furthermore, ai-based devices for monitoring women’s periods of fertility are recognized as femtech products in the area of reproduction. 40 with the ————————————————————————————— 33. id. 34. on the aivf start-up, see next generation ivf, aivf, https://aivf.co/ [https://perma. cc/a39c-x6xj] (last visited oct. 15, 2024). 35. id. 36. id. 37. raz smolsky & tal shahaf, the start-up that uses artificial intelligence in ivf treatments raises 25 million dollar, tech12 (june 22, 2022), https://www.tech12.co.il/indexstartups/article-1a0b6e5a03b8181027.htm [https://perma.cc/w7bw-supg]. 38. id. 39. an example of a self-scan ultrasound device, for ai-based and remote clinical diagnosis, was created and is produced by pulsenmore. see bridging healthcare gaps with home ultrasound, pulsenmore, https://pulsenmore.com/ [https://perma.cc/b7re-6m23] (last visited on oct. 22, 2024). 40. period-tracking applications are currently a “hot commodity,” ranking as the fourth most popular application for adults in health care, and the second most popular among adolescents. see corbin, supra note 5, at 344. https://perma.cc/b7re-6m23 https://pulsenmore.com https://perma.cc/w7bw-supg https://www.tech12.co.il/index https://perma https://aivf.co 2025] the use of artificial intelligence 101 support of ai systems, these devices aspire to help women accurately identify their fertile window. 41 integrating ai in ivf treatments, self-scan ultrasound devices for ai-based diagnosis, and ai-based devices for monitoring women’s ovulation periods are all illustrations of ai breakthroughs in the market, concerning female fertility and reproduction. c. sexuality the third and last area of expertise to be illustrated concerns femtech products that aim to foster healthy female sexuality in women’s lives. good examples for such products are ai-based applications that ease symptoms of menopause. 42 femilog, for instance, is an application for documenting individual menopause symptoms, such as a sore and dry vagina or hot flashes. 43 based on this documentation, the application offers personal-fitted recommendations. 44 another company, astinno, developed an automated tracking and cooling bracelet that is ready to detect and fend off hot flushes. 45 when hot flushes are detected, a cooling patch is activated on the woman’s wrist, which reverses the effects of the flush. 46 obviously, the development of ai-based technologies in the areas of female diseases, fertility, and sexuality, could not have been fulfilled without significant capital. the following section discusses the unique challenges of funds raising in the femtech industry. ————————————————————————————— 41. take, for example, the product tempdrop. the tempdrop sensor is worn on the upper arm during sleep and continuously monitors the basal body temperature while the woman sleeps, in order to identify the fertile window. the sensor is synchronized with an application that analyzes the data with an ai-based algorithm. see monitor your fertility: the smart solution for fertility tracking, tempdrop, https://www.tempdrop.com/en-il [https://perma.cc/dv6wwac5] (last visited oct. 22, 2024). 42. the digital health company lisa health, for example, creates advanced technology solutions for menopause and healthy aging. it launched midday, an application that leverages ai, sensor technology and digital therapeutics to support women during menopause. see tia r. ford, lisa health launces midday, an app leveraging ai to personalize the menopause journey, in collaboration with mayo clinic, mayo clinic news network (july 19, 2022), https:// newsnetwork.mayoclinic.org/discussion/lisa-health-launches-midday-an-app-leveraging-ai-topersonalize-the-menopause-journey-in-collaboration-with-mayo-clinic/[https://perma.cc/45q93k38]. 43. see cate lawrence, why denmark is a hotbed for healthtech startups and innovation, techeu-healthtech (jan. 16, 2024), https://tech.eu/2024/01/16/why-denmark-is-a-hotbed-forhealthtech-startups-and-innovation/ [https://perma.cc/ejc7-wvfp]. 44. id. 45. see natasha lomas, uk femtech startup astinno, which is working on a wearable to combat hot flushes, picks up grant worth $450k, techcrunch (may 13, 2020), https:// techcrunch.com/2020/05/13/uk-femtech-startup-astinno-which-is-working-on-a-wearable-tocombat-hot-flushes-picks-up-grant-worth-450k/ [https://perma.cc/9629-9h22]. 46. id. https://perma.cc/9629-9h22 https://techcrunch.com/2020/05/13/uk-femtech-startup-astinno-which-is-working-on-a-wearable-to https://perma.cc/ejc7-wvfp https://tech.eu/2024/01/16/why-denmark-is-a-hotbed-for https://newsnetwork.mayoclinic.org/discussion/lisa-health-launches-midday-an-app-leveraging-ai-to https://perma.cc/dv6w https://www.tempdrop.com/en-il indiana health law review [vol. 22:93 102 iv. raising funds for the femtech industry and its challenges though women are half of the world’s population, the women’s health market has traditionally been considered negligible.47 until recently, investments in technologies related to women’s health were a relatively small share of all investments in life sciences. 48 the negligible investment in the femtech industry can be explained by the historic neglect of women’s health.49 as one of the founders of aquafit intimate, rivka sternberg, stated: we understood very quickly that the femtech model does not fit local foundations . . . . these foundations invest in companies and do not mind losing a lot of money at first, but not in femtech. in femtech, economic feasibility is required from the very beginning. this economic standard is not realistic for most start-ups. i have been an entrepreneur for almost thirty years, and there is a . . . . double moral standard here. male impotency is worth billions. it is only female sexual health that is forbidden to talk about. i sincerely do not understand why viagra is a market, but a product for vaginal health is a risk. 50 only a small percentage of the investors are women, and men find it hard to understand women’s needs.51 therefore, the chances of raising funding for a high-risk project in women’s health are low. 52 moreover, conservative social perceptions may be an economic obstacle for the femtech industry. ceos in this industry claim, for instance, that they need to invest much more money in marketing, since every mention of the word “vagina” is blocked on facebook, due to suspicion of pornography. 53 women are also known to be very unpredictable customers, who are not open to new technologies and to exploring new devices – a fact that may also make raising funds more difficult. 54 ————————————————————————————— 47. see, e.g., priya joi, women’s health is massively underfunded and is one of the biggest missed opportunities in health, vaccineswork (may 22, 2023), https://www.gavi.org/ vaccineswork/womens-health-massively-underfunded-and-one-biggest-missed-opportunitieshealth [https://perma.cc/wj8a-umx7]; karen rubin & april popescu, why women’s health is a $500m problem worth solving, medium (apr. 5, 2022), https://medium.com/@karenrubin/ why-womens-health-is-a-500m-problem-worth-solving-d0f3696e1c6a [https://perma.cc/v6ebtc4r]. 48. id. 49. id. 50. see roni dori, perimenopause age to front stage, calcalist (may 4, 2022), https://newmedia.calcalist.co.il/magazine-04-05-22/m02.html [https://perma.cc/t66a-kxky]. 51. id. 52. id. 53. id. 54. interview with eng. hilla shaviv, inventor, founder and ceo gals bio ltd, supra note 31. https://perma.cc/t66a-kxky https://newmedia.calcalist.co.il/magazine-04-05-22/m02.html https://perma.cc/v6eb https://medium.com/@karenrubin https://perma.cc/wj8a-umx7 https://www.gavi.org 2025] the use of artificial intelligence 103 however, in recent years, femtech developments are rapidly increasing. 55 according to the research company, global market insights, the femtech market is already estimated at twenty-two billion dollars, and it is expected that it will triple its value by 2027. 56 the economic potential embedded in the femtech industry is recognized as one of the major catalysts for investing in this industry. 57 as one of nevia’s founders, inbal zafir-lavie, states: i also had the chance to stand in front of a panel of investors, ten men wearing ties, and talk to them about vaginal discharge. at first, there is some kind of inconvenience, but it is over the moment they understand the economic potential. male investors are very trained; they do not show how they think […], and the moment they understand we can bring them money and make them blockbusters – this is all they are interested in.58 she continues and argues that female investors have also fostered the rise of the femtech industry:59 i think that the female sex understood that ‘if not us – then who’. i don’t have any claims against men, but at the end of the day, you take care of issues that concern you. 60 (emphasis added) as can be understood from the above, the difficulties of raising funds for the femtech industry go hand by hand with the struggle for women’s equality in the world. the historic neglect of women’s health, the small number of female investors compared to male investors, and conservative social perceptions have turned the task of raising funds for the femtech industry into a most challenging one. the recent increase in raising of capital for this market niche does not only serve women’s needs, but also reflects a step toward a more equal allocation of funds. v. research questions, approach, and method while most public attention is paid to the challenge of fundraising for femtech developments, 61 the bioethical dilemmas raised by the femtech ————————————————————————————— 55. see dori, supra note 20. 56. id. 57. id. 58. id. 59. id. 60. id. 61. see melissa houston, the challenges of raising capital for business owners in the femtech industry, forbes (sept. 29, 2021), https://www.forbes.com/sites/melissahouston/2021/ 09/29/the-challenges-of-raising-capital-for-business-owners-in-the-femtech-industry/?sh=7797f 75f7266 [https://perma.cc/nul6-xyp3]. https://perma.cc/nul6-xyp3 https://www.forbes.com/sites/melissahouston/2021 indiana health law review [vol. 22:93 104 industry have received inadequate attention. 62 my research provides an account of these dilemmas, from a feminist’s perspective. i explored how the femtech revolution can affect women and asked: do the technologies, which aim to improve women’s health, address new challenges facing feminist ethics and social philosophy? or, do they simply raise old bioethical questions, in relation to new technologies? by adopting a sociological perspective toward bioethics, i offer an initial discussion on the opportunities, alongside the challenges, that the ai-based femtech industry faces, from a feminist perspective. the discussion is based on representative and non-exhaustive examples of developments from the femtech industry. followed by a comparative normative analysis, the discussion aims at setting the basis for feminist regulation of ai-based medical devices. vi. the opportunities and challenges of ai-based femtech products women’s health is historically known as a neglected field. 63 the femtech industry – which is partially based on ai – fosters gender equality by shedding light on a traditionally under-treated topic. nevia’s algorithm, for instance, is designed, inter alia, to detect endometriosis. 64 nevia’s algorithm, thus, is a good example of how ai in medicine can raise awareness of socio-medical problems. it offers a new source of data for bio-banks and detects illnesses that are rarely diagnosed or treated. of course, the lack of available research and data concerning women’s health seriously challenges the development of new technologies related to it. in addition to fostering equality between men and women, the femtech industry addresses the feminist slogan “my body, my choice” by strengthening women’s autonomy over their bodies. femtech products enable women to take responsibility for their bodies and health. 65 these products offer services and solutions that the doctor’s office does not – be the direct access to professional testing and diagnosis from home, anonymity, and respect for busy schedules, which are all crucial for women. for women juggling domestic loads and work, there is little time to schedule in-person healthcare appointments. in addition to this obstacle, long waitlists, and healthcare bias and discrimination can make it even harder for women to be seen by medical staff and to receive appropriate care. 66 ————————————————————————————— 62. for an exceptional article discussing the bioethical dilemmas surrounding the femtech industry, see generally corbin, supra note 5. 63. id. at 338. 64. see the new way for early detection, supra note 18; see also dori, supra note 20. 65. see corbin, supra note 5, at 338. 66. see, e.g., vee govender & loveday penn-kekana, gender biases and discrimination: a review of health care interpersonal interactions, 3 glob. pub. health 90, 93–94 (2008). 2025] the use of artificial intelligence 105 the femtech industry provides accessibility to healthcare services for disadvantaged populations. we know, for example, that there are massive racial disparities in pregnancy-related deaths. 67 statistics overwhelmingly show that black women are more likely to die during pregnancy than white women are. 68 research has also found that black patients are more likely to wait longer for a primary doctor’s appointment and are less likely to be offered pain relief than white patients. 69 living in a rural area, distance, and transport issues can also dramatically affect access to healthcare and, of course, these challenges become even greater for disabled women and women who are caregivers. femtech products succeed in working directly with communities and reaching marginalized groups. they reduce health disparities and provide unbiased care. supplying direct healthcare services and reaching marginalized communities enable the detection, diagnosing, and treating of the disease at early stages. therefore, the femtech industry can also save a great deal of money for the government. 70 femtech products, therefore, not only provide solutions to women from marginalized communities, but due to frequent use of ai, the products can mitigate discrimination stemming from human biases and social structures. in light of all the opportunities that ai-based femtech products invite, can we state that the femtech revolution advances equality between sexes and is committed to the feminist ethos? alongside its significant advantages for women’s lives, it appears that the use of ai technology in the health sector also raises serious legal and bioethical challenges from a feminist perspective. three of these challenges will be discussed now. a. the problem of bias i argued before that ai-based technology has the potential to mitigate human biases and discriminations grounded in social structures, by using an ————————————————————————————— 67. see roni caryn rabin, huge racial disparities found in deaths linked to pregnancy, n.y. times (may 7, 2019), https://www.nytimes.com/2019/05/07/health/pregnancy-deaths-.html [https://perma.cc/cf5j-ge9k]. 68. id. 69. see janna m. wisniewski & brigham walker, association of simulated patient race/ethnicity with scheduling of primary care appointments, 3 jama network open 1, 1 (jan. 29, 2020), https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6991290/ [https://perma.cc/ jfd7-srkp]; antoinette schoenthaler & natasha williams, looking beneath the surface: racial bias in the treatment and management of pain, 5 jama network open 1, 1 (june 9, 2022), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793179 [https://perma.cc/4yye-xzef]. 70. based on a study from 2012, one of nevia’s founders claimed that the economic burden of endometriosis is the same as that of type-2 diabetes, and is estimated to cost the u.s. economy $50 billion. see dori, supra note 20. she asserted: “when a woman comes to the emergency room, is hospitalized, and later told to go home, since ‘it’s just menstrual cramps’, but then returns a few hours later with paralyzing pain that could cause her to lose her fertility […] that’s a problem. this doesn’t only just harm women, but it is a burden on the entire health care system and on society.” id. https://perma.cc/4yye-xzef https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793179 https://perma.cc https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6991290 https://perma.cc/cf5j-ge9k https://www.nytimes.com/2019/05/07/health/pregnancy-deaths-.html indiana health law review [vol. 22:93 106 objective and neutral algorithm. however, ai-based technology may also foster unwanted discrimination. this discrimination does not have to be necessarily intentional (i.e., a biased algorithm is deliberately designed in order to prioritize one group over another). the discrimination can also unintentionally stem from the feature selection or data that serve the decision-making model. when aibased technology trains on data that either reflect an existing bias in society or is not representative, the innovative technology will duplicate and continue discrimination. 71 medical studies are a good example for this kind of discrimination.72 these studies have been historically conducted on males and, therefore, the amount of data concerning men is significantly larger than the amount of data concerning women. 73 hence, ai-based medical diagnosis tools may be biased, less effective and discriminatory toward women. a diversity in data used for training and features for selection are required, in order to deal with the bias problem embedded in ai-based medical tools. how can such a diversity be achieved? moreover, do diverse features for selection maintain the goal of an ai algorithm, from the very beginning? take, for example, the aivf algorithm, mentioned above. do diverse features for selection of the best embryos for fertilization maintain the goal of identifying the one formula for selecting the embryos that have the best chance to turn into pregnancy? among the advantages of aivf algorithm are that the algorithm shortens the one-cycle treatment time, diminishes the number of treatment cycles, and eases the physical and mental suffering of the women. 74 embryo selection by humans is highly subjective and changes between embryologists and laboratories. in contrast, an ai algorithm used for selecting embryos is perceived as more objective, neutral, and consistent. responsible ai selection of embryos requires integrating the work of human beings and machines.75 the algorithm dictates who is allowed to join the human community and who is not, and which lives are worth living and which lives are not. the aivf algorithm advances the race for the perfect child, fosters discrimination of people with disabilities, and may lead to human enhancement, and even eugenics. above all, i would like to offer that using ai in ivf treatments may endanger human evolution itself. human mutations are required in order to ensure evolution and, therefore, nothing fails like a successful ai ————————————————————————————— 71. a technological solution for such a problem is to periodically cleanse the data used for training. however, if a social bias is deeply rooted in culture, it will take time until the cleansing mechanism’s affects are visible. 72. corbin, supra note 5, at 342. 73. id. 74. the aivf algorithm raises the tension between women’s interests and the rights of people with disabilities. on the one hand, this technology helps ease the often difficult experiences of ivf treatments for women. on the other hand, the practice of choosing flawless embryos for transplantation itself sends a message that there are lives which are not worth living. tamir, supra note 32 for information and discussion of this tension. 75. on the ethical debate over ai in ivf, see generally tamir, supra note 32. 2025] the use of artificial intelligence 107 algorithm. 76 we could argue that using ai in ivf treatments simply mimics the embryo selection that already exists in nature. an additional argument, from a different direction, can be that there is nothing new under the sun of ai. there has been embryo selection for several decades, with the pre-implantation diagnosis technique (pgd) as only one example of it. however, the change that might occur, as we move away from the traditional embryo selection process to an ai world, is that the process will become consistent, uniform and, above all, less diverse. human embryologists or laboratories might succeed, more or less. nonetheless, they offer us a much more random, arbitrary, incidental, and, therefore, diverse, process of embryo selection. in order to achieve social fairness and an unbiased algorithm, the principle of inclusiveness has been adopted by regulatory regimes for ai. 77 how can we understand the principle of inclusiveness and the race for diversity with respect to ai in medicine? the medical anthropologist, sandra soo-jin lee, attributes a dual meaning to diversity: (1) it is a solution to the technical problem of capturing genetic variation, and (2) it fulfills the ethical imperative to include marginalized social groups in medical research. 78 indeed, more and more medical sociologists are studying the ways in which the categories of identities are organized in bio-banks. 79 inter alia, they examine the extent to which epigenetic parameters should be taken into account. 80 they warn that ai’s endeavor to harmonize variables and blur differences in life experiences can affect the health of the technology’s consumers. 81 according to these medical sociologists, common disease etiology should be studied with a growing ————————————————————————————— 76. a good example of this argument can be taken from another technological procedure of gene editing, crispr-cas9 technology. the crispr-cas9 gene editing technology is used, inter alia, for the purpose of repairing the mutation in the hemoglobin gene responsible for sickle cell anemia. see christian e. ogaugwu, stanley o. agbo & modinat a. adekoya, crispr in subsaharan africa: applications and education, 37 trends biotechnology 234, 235 (2019). however, while this technology has demonstrated highly satisfactory results, by curing people diagnosed with sickle cell diseases, it has been found to be problematic for people most in need of it. id. eighty percent of the people suffering from sickle cell anemia live in africa. id. at 236. while crispr-cas9 technology could cure their disease, it was found that it simultaneously harms their immunity to malaria, a much more life-threatening disease in africa. id. at 234. in order to minimize the risk of such catastrophes for evolution, scientists have decided to use the gene editing technology only in order to cure the individual patient, and never to edit the germ cells, which can also affect future generations. id. at 236. i wonder what the parallel decision for the use of ai in ivf treatments should be. 77. see world health organization guidance, supra note 16. 78. see the israel academy of sciences & humanities, 2050: bioethical issues, the ethics of diversity, inclusion and global data harmonization in the age of precision – sandra soo-jin lee, youtube (oct. 25, 2023), https://www.youtube.com/watch?v=snkoykwcmmy [https:// perma.cc/9c9x-z2qh]. 79. see, e.g., sandra soo-jin lee et al., the ethics of characterizing difference: guiding principles on using racial categories in human genetics, 9 genome biology 404–06 (2008). 80. see sara l. ackerman et al., the ethics of translational science: imagining public benefit in gene-environment interaction research, 3 engaging sci. technol. soc. 351, 362– 63 (2017). 81. id. at 352–53. https://www.youtube.com/watch?v=snkoykwcmmy indiana health law review [vol. 22:93 108 understanding of, and explicit attempts to, study the many ways that bodies and environments are inextricably linked. 82 as one scientist puts it: “genes . . . are really important in physiologic functioning, and . . . almost all genetic effects are contingent on some environment.”83 it should be noted that the sociologist’s imperative to take into account epigenetic parameters and life experiences are in line with feminist ethos. the feminist movement (mainly, its second wave) has emphasized the importance of taking into account the lived phenomenological experience of women.84 in order to include epigenetic parameters and life experiences in data, which will be the basis for organization in bio-banks’ categories, a collaboration across disciplines is required. biologists and behavioral and environmental scientists need to work together in the process of building categories in bio-banks. in this spirit, critics have argued that the welcome collaboration between biologists and social/behavioral or environmental scientists may lead to greater attention to how particular social and material environments are embodied in biological processes.85 in order to include epigenetic parameters in bio-banks, biologists and social scientists, working together, should make an effort to reconstruct an individual’s geographic ancestry, so that we will have results that reflect the broader context of an individual’s ancestry. an individual’s ‘geographic ancestry’ or ‘biogeographical ancestry’ is understood in the literature as all the geographic locations inhabited by an individual’s biological ancestors. 86 the idea is that genetic data reflect only a small subset of all ancestors. furthermore, an individual’s self-definition can be different from their biogeographic ancestry, due to varied historical, cultural, or sociopolitical factors. therefore, a collaboration between biologists and social scientists is required in order to build biogeographical and cultural ancestry. in order to ensure the establishment of an interdisciplinary ancestry, and to refrain from using stereotypical and stigmatized categories, medical anthropologists encourage all researchers, who use identity categories in bio-banks to do a number of things. they encourage researchers to describe how individual samples are assigned category labels, to explain why samples with such labels were included in the study, and to state whether the identity categories are research variables. 87 the editorial boards of ————————————————————————————— 82. id. at 363–65. 83. id. at 359. 84. see generally, e.g., feminist phenomenology (linda fisher & lester embree eds., 2000); louise levesque-lopman, claiming reality: phenomenology and women’s experience (1988); feminist interpretations of maurice merleau-ponty (dorothea olkowski & gail weiss eds., 2006); sandra lee bartky, feminist and domination: studies in the phenomenology of oppression (1990). 85. see sources cited supra note 84. 86. see soo-jin lee et al., supra note 79, at 405. 87. id. 2025] the use of artificial intelligence 109 several flagship scientific journals have issued publication guidelines to their authors on the use of ‘race’, for example, in reporting research findings.88 indeed, the pursuit of diversity raises serious questions in relation to how to describe, define, measure, compare, and explain inferred similarities and differences among individuals and groups. social parameters, such as selfdefinition, or perception of the other, may justify the differentiation or unification of categories. for example, studies have shown that american adults, who do not self-identify as white, report better mental and physical health if they think others perceive them as white. 89 as in epigenetic parameters and lived experiences, the social parameter of self-identification is also in line with feminist ethos. from its very early stages, the feminist movement encouraged women to have an independent point of view, to be able to have self-identification, and not to blindly adopt the “universal” (namely, the male) perspective. 90 bio-bank categories and their organization have also had reciprocal effects on society and its ideologies. sandra soo-jin lee identified an “infrastructure of racialization” in bio-banks that incorporated racialized labels for groups whose dna samples they store. 91 in so doing, according to lee, they privileged the human body as the grounds in and from which racial difference can be read, and genomics as the official language for reading race. 92 furthermore, duana fullwiley found much the same in her ethnography of two medical genetics laboratories in the united states. she showed how the comparison between the allegedly pure “old world” reference populations to “new world” admixed populations led scientists to read race in dna and revive race as biogenetically valid.93 nevertheless, the turn to classification as a problem may obscure other ways of understanding how difference matters. abolishing “racist categories” through careful language and more precise genetic distinctions both sidesteps the issue and distracts from the recognition that racial categorization is embedded within institutions and processes that sustain configurations of power and reproduce racial inequalities in health. it appears that the immediate and direct response to the bias problem, related to ai-based medical technology, is the fulfillment of the inclusiveness principle through including diverse data. diverse data can be achieved by including non-representative populations, such as women in the data. moreover, modifying data to suit new target audiences when medical ————————————————————————————— 88. id. 89. sandra soo-jin lee et al., ethics of inclusion: cultivate trust in precision medicine, 364 sci. 941, 942 (2019). 90. see tony lawson, feminism, realism, and universalism, 5 feminist econ. 25, 44, 49 (1999). 91. janet k. shim et al., race and ancestry in the age of inclusion: technique and meaning in post-genomic science, 55.4 j. health soc. behav. 504, 506 (2014). 92. id. 93. id. indiana health law review [vol. 22:93 110 devices are applied in contexts different from their original intended use can promote the principle of inclusiveness. 94 however, i have argued that diverse data will also be enabled by engaging in new methods of data collection, such as the inclusion of epigenetic parameters and the individuals’ self-identification, which are in line with the feminist ethos. the classification problem in bio-banks raises the well-known issue of politics of identities and positions that questions who is considered “black,” what it means to be a “woman,” etc. these questions, so i claimed, should be answered by bio-ethicists and social scientists working together. i additionally think that empirical research is required in order to understand how to conceptualize diversity in bio-banks and which goals of inclusion are implemented. building categories in bio-banks is not only a matter of population recruitment and its classification. it should also be a matter of population involvement, starting from data collection, their measurement, and their interpretation. up until here, i described and appraised the bias problem currently facing ai-based medical devices. nonetheless, the danger of discrimination stemming from ai-based medical devices may relate also to the future. the use of ai algorithms in femtech products is potentially dangerous, since, due to their predictive abilities, they can create perceptions of normalcy and support discriminatory stereotypes in society. if an ai algorithm can predict the chances of developing a certain disease, social discrimination based on this potential future disease is not hard to imagine. think of an ai algorithm that predicts the chances of a woman being diagnosed with als. the predicted future possibility of becoming disabled may cause discrimination in the job market, for instance, against candidates, who are defined as having risk factors, according to ai predictions.95 how does a possibility of future prediction-based social discrimination affect the design of an ai regulatory regime? to what extent are ai medical predictions different from other traditional medical records? 96 these are some of the questions facing future regulation of ai-based medical devices. in conclusion of this section, alongside the potential of ai-based femtech products to mitigate biases toward women, they can also foster discrimination (whether it be deliberate, unintentional, or consequential). i argued that the principle of inclusiveness should be advanced, in order to achieve social fairness. the development of the techniques need to also take into account ————————————————————————————— 94. see generally boris babic et al., algorithms on regulatory lockdown in medicine: prioritize risk monitoring to address the “update problem”, 366 sci. 1202 (2019). 95. on the risk of being discriminated against in the job market, due to predicted future possibilities of becoming disabled, see generally, e.g., sharona hoffman, big data’s new discrimination threats: amending the americans with disabilities act to cover discrimination based on data-driven predictions of future disease, in big data, health law, and bioethics 85 (glenn cohen et al. eds., 2018). 96. of course, the potential of discriminatory future effects of ai-based technologies is not unique to femtech products. however, due to the fact that women are a vulnerable population in the job market, ai discriminatory future effects are more devastating. 2025] the use of artificial intelligence 111 epigenetic parameters and individuals’ self-definitions that are in line with feminist ethos. in order to fulfill this ambition, a collaboration across disciplines is required. b. constructing stereotypical social perceptions about women as in all other technologies, ai-based medical devices can also construct social perceptions. nevia’s algorithm, mentioned above, is a good example of how femtech can raise awareness of socio-medical problems. it offers a new source of data for bio-banks and detects illnesses that are rarely diagnosed and treated. detecting rarely diagnosed and treated illnesses is enabled due to the development of smart pads that are available to all women. however, femtech products may also advance unwelcome and reactionary social perceptions. they may be based on incorrect assumptions of female needs and desires that not only stereotype women, but also serve to define the default female body. take, for example, an application that tracks periods. by sending a notice to the woman’s smartphone, the application can inform a woman in welcoming letters and a positive tone that they are late for their period. the woman may have to continue seeing the notice, even if they are preparing for an abortion, since the application’s designers clearly misunderstood that pregnancy is not always a welcome occurrence. 97 moreover, when an abortion or miscarriage happens, some applications prevent women from logging this data, a fact that sends them a message that their experience falls outside normal data calculations. 98 while the world embraces the ongoing ai revolution, the example of a period-tracking application shows us that new technological developments can have devastating consequences, as they impose social perceptions of normalcy on women. in light of this understanding, the socio-legal question to be asked is: how do we advance femtech products that do not support stereotypes of women? in other words, how do we guarantee regulatory regimes that encourage the development of welcome awareness of existing social problems? and, how do we discourage the design of unwelcome narrow-minded social perceptions? is it only a problem of diversity? will diverse representation within the company ensure that all social viewpoints are acknowledged and considered? or, will ai-based technologies subvert some of the most crucial feminist achievements – that is taking into account women’s needs and worlds of content. c. challenging privacy due to the fact that ai technology frequently uses large amounts of data for the purpose of its development, training, and operation, it raises serious ————————————————————————————— 97. see corbin, supra note 5, at 349. 98. id. indiana health law review [vol. 22:93 112 challenges to privacy. 99 firstly, it should be examined whether consent was given for the use of the person’s data that includes personal information. the collection and use of personal data should be limited to purposes stated in the law. thus, during data collection, the individual should know (at least in theory) why their data is being collected, for which they gave their consent in advance. however, ai technology frequently uses data for purposes that differ from the original reason for the collection. transforming the target of data collection by ai technology also raises an ethically controversial question concerning this technology: do we use ai technology in order to cure the people from whom we collected data, or do we use certain people in order to cure others? furthermore, the difficulty of explaining how the technology works may also make it more difficult to receive consent. ai-based medical technologies challenge individuals’ privacy in too many and complex ways to be seriously handled in this article. my goal in this section is much more modest. here, i aim to shed light on why the threat to women’s privacy is so important that this issue needs to be more urgently handled. when it comes to women, the use of data derived from their bodies, without gaining their informed consent, is even more problematic. for years, the feminist movement has been working to ensure that women will gain autonomy over their bodies, so that they can make decisions concerning their bodies. 100 this perception has been expressed by the slogan “my body, my choice.”101 an additional challenge to privacy protection, related to ai technology, comes from cyber attacks. 102 these attacks may specifically threaten women’s autonomy over their bodies and undermine some of the most important feminist achievements, such as abortion rights. information stored on period trackers, for example, can be used by governments banning abortions, in order to determine if a woman has had an illegal abortion. therefore, significant restrictions on how femtech companies collect, use, store, or disclose health data should be regulated in order to preserve women’s autonomy over their bodies.103 ————————————————————————————— 99. see, e.g., effy vayena, protecting health privacy in the world of big data, in big data, health law, and bioethics 157 (glenn cohen et al. eds., 2018); karl manheim & lyric kaplan, artificial intelligence: risk to privacy and democracy, 21 yale j.l. & tech. 106, 116–31 (2019). 100. see, e.g., diana tietjens meyers, the feminist debate over values in autonomy theory, in autonomy, oppression, and gender 114 (andrea veltman & mark piper eds., 2014); moira gatens, imaginary bodies: ethics, power, and corporeality 1, 49 (1996). 101. on the controversial use of this slogan, see generally abdul rasheed sajid, my body my choice: history of this culture 1 (2021). 102. on potential dangers of digital surveillance of women and their bodies, see cynthia conti-cook, surveilling the digital abortion diary, 50 u. balt. l. rev. 1, 3–74 (2020). 103. on how femtech products can address gaps created by u.s. states and stakeholders seeking to restrict birth control and abortion access while increasing pregnancy surveillance, as well as potential solutions, see fowler & ulrich, supra note 5. on the oppression women suffer through a loss of privacy in the digital age, see gilman, supra note 5. 2025] the use of artificial intelligence 113 vii. toward feminist regulation of ai-based medical devices: bioethical principles, regulatory regime & legal accountability in light of these challenges facing ai-based femtech products, i now examine how to set a legal and regulatory basis for feminist ai. i am specifically interested in the bioethical principles that should be taken into account when advancing feminist regulation of ai technologies. the bioethical principles, in relation to ai-based femtech products, should combine three sets of principles. the first is the long-standing principles of bioethics, which advance the patient-centric approach relating to personal and societal aspects of implementing the medical device. 104 the second is the currently evolving ai ethics, which foster the human-centric ai ethics, with respect to the technological architecture of medical devices (i.e., the design of ai in a way that keeps humankind interests protected against ai’s capabilities). 105 the third is feminist ethics, which places women’s perspectives on caring and moral issues of private life and family responsibilities on ‘center stage’. 106 this principle gives more weight to cultural female traits, such as: connection, community, sharing, emotion, and absence of hierarchy. 107 if we want to outline feminist bioethical principles relating to ai-based medical devices, then a woman-centric logics should be adopted. ————————————————————————————— 104. world health organization guidance, supra note 16; principles of artificial intelligence ethics for the intelligence community, off. of dir. of nat’l intel. (2020), https://www.dni.gov/files/odni/documents/principles_of_ai_ethics_for_the_intelligence_co mmunity.pdf [https://perma.cc/kmk9-y9p9]. 105. see sources cited supra note 104. ai ethics principles are currently being developed mainly by international organizations, governments, civil society organizations, and by voluntary self-regulation of the technology industry. see, e.g., ai principles overview, oecd, https://oecd.ai/en/ai-principles [https://perma.cc/9gp8-w7qw] (last visited oct. 31, 2024); high-level expert group on artificial intelligence: ethics guidelines for trustworthy ai, eur. comm’n, (apr. 8, 2019), https://op.europa.eu/en/publication-detail/-/publication/d39885690434-11ea-8c1f-01aa75ed71a1[https://perma.cc/v3mq-274b]; unesco, final report on the draft text of the recommendation on the ethics of artificial intelligence 1–10 (mar. 31, 2021), https://unesdoc.unesco.org/ark:/48223/pf0000376712 [https://perma.cc/2nmj-e87t]; off. of mgmt. & budget, exec. off. of the president, memorandum, guidance for regulation of artificial intelligence applications (2020); asilomar ai principles, future of life inst. (aug. 11, 2017), https://futureoflife.org/open-letter/ai-principles/ [https://perma.cc/ 4kjx-6vyz]; artificial intelligence at google: our principles, google, https://ai.google/static/ documents/en-ai-principles.pdf [https://perma.cc/uf26-ulds] (last visited oct. 31, 2024); responsible ai transparency report, microsoft (may 2024), https://query.prod.cms.rt. microsoft.com/cms/api/am/binary/rw1l5bo [https://perma.cc/2w5a-esb2]. 106. for literature on feminist ethics, see, e.g., maurice hamington, embodied care: jane addams, maurice merleau-ponty, and feminist ethics (2004); fiona robinson, the ethics of care: a feminist approach to human security (2011); cristina h. traina, feminist and natural law: the end of anathema (1999). 107. see sources cited supra note 106. https://perma.cc/2w5a-esb2 https://microsoft.com/cms/api/am/binary/rw1l5bo https://query.prod.cms.rt https://perma.cc/uf26-ulds https://ai.google/static https://perma.cc https://futureoflife.org/open-letter/ai-principles https://perma.cc/2nmj-e87t https://unesdoc.unesco.org/ark:/48223/pf0000376712 https://op.europa.eu/en/publication-detail/-/publication/d3988569 https://perma.cc/9gp8-w7qw https://oecd.ai/en/ai-principles https://perma.cc/kmk9-y9p9 https://www.dni.gov/files/odni/documents/principles_of_ai_ethics_for_the_intelligence_co indiana health law review [vol. 22:93 114 a global landscape analysis from 2019 identified global convergence around five ethical principles relating to ai technology. 108 these five ethical principles are justice and fairness, transparency, non-maleficence, responsibility, and privacy.109 healthcare-specific ai ethics principles are also being gradually formed, though these are at an even more initial stage of development, with very few examples. in 2018 and 2019, the american medical association’s (ama) outlined its policy on augmented intelligence in health care.110 the who also outlined its policy on ethics and governance of artificial intelligence for health. 111 this framework identified the following key ethical principles for the use of ai for health: ensuring inclusiveness and equity; protecting human autonomy; ensuring transparency, explainability, and intelligibility; promoting human well-being and safety, and the public interest; fostering responsibility and accountability; and promoting ai that is responsive and sustainable. 112 as for feminist-specific ai ethics, to date, i have not found any such published frameworks. given the initial stage of ai-based technologies, and due to the yet to be studied ai’s potential benefits, alongside its harmful potentialities, i do not intend to offer an exhaustive feminist theory for ai-based medical devices for women. instead, i take a principle-based approach and apply relevant bioethical principles and feminist considerations to the novel technology of ai. the following discussion examines how to apply bioethics and ai ethics principles in the femtech industry. a. social justice and fairness social justice and fairness are, in fact, cited by the european commission’s high-level expert group on ai as one of four ethical imperatives necessary for trustworthy ai. 113 what could be considered as “fair” and “just” in the context of ai-based medical tools for women? the problem of biased algorithms and the pursuit of diversity data, concerning ai-based medical devices, are often————————————————————————————— 108. anna jobin et. al., the global landscape of ai ethics guidelines, 1 nature machine intel. 389, 389 (2019). 109. id. 110. augmented intelligence in health care h-480.940, am. med. ass’n, https://policysearch.ama-assn.org/policyfinder/detail/augmented%20intelligence?uri=%2fama doc%2fhod.xml-h-480.940.xml [https://perma.cc/w487-4e8n] (last visited jan. 12, 2025); augmented intelligence in health care h-480.939, am. med. ass’n (2019), https://policysearch. ama-assn.org/policyfinder/detail/ai?uri=%2famadoc%2fhod.xml-h-480.939.xml [https:// perma.cc/wep6-8wx5] (last visited jan. 12, 2025). 111. world health organization guidance, supra note 16. 112. id. 113. high-level expert group on artificial intelligence: ethics guidelines for trustworthy ai, supra note 105. https://policysearch https://perma.cc/w487-4e8n https://policysearch.ama-assn.org/policyfinder/detail/augmented%20intelligence?uri=%2fama 2025] the use of artificial intelligence 115 debated topics in the bioethical analysis of ai. 114 in terms of biology, an aibased medical device that uses non-diverse data is highly problematic and may produce unsatisfactory results. by adopting a sociological perspective toward bioethics, i suggest that in order to understand the ai-related diversity principle, we must approach it not only as a biological necessity, but also as a social imperative.115 the ways in which the categories of identities are organized in bio-banks illustrates the social imperative regarding the diversity principle. i propose that epigenetic parameters, for instance, will be taken into account, for the purpose of organizing identity categories in bio-banks. 116 moreover, the self-definition of individuals, whose data have been collected, should be regarded. taking into account epigenetic parameters and self-definitions is also supported by feminist ethics that fosters female traits, such as community, sharing, and emotion. 117 in general, the very categories, techniques, and objects of scientific practice should also be studied from a social point of view, in order to fulfill the principle of diversity. furthermore, we should think of how to generate principles to guide the use of identity categories in bio-banks. the fear is that, under certain conditions, genetic data might transform social understanding of identity categories that can enhance misogynist ideology. b. autonomy, transparency, and explainability the phrase “striking a balance between the decision-making power we retain for ourselves and that which we delegate to artificial agents” is defined as an ai ethics’ sense of autonomy in light of the human-centered approach. 118 in order to guarantee this kind of balance, according to the 2019 ethics guidelines ————————————————————————————— 114. see, e.g., sarah e. malanga, et. al., who’s left out of big data?: how big data collection, analysis, and use neglect populations most in need of medical and public health research and interventions, in big data, health law, and bioethics 98–99 (glenn cohen et al. eds., 2018). 115. steven epstein argues that we are now fully in an age of inclusion, in which the regulatory mandate to include underrepresented populations has become both scientific and social common sense. see generally steven epstein, inclusion: the politics of difference in medical (2007). on the requirement for diversity as social common sense, see also shim et al., supra note 91, at 505. 116. a number of publications, many of them authored by prominent leaders from the u.s. national institutes of health, calls for research exploring the mutual and synergistic interactions of genetic and environmental determinants on human health. see, e.g., francis s. collins, et. al., a vision for the future of genomics research: a blueprint for the genomic era, 422 nature 835 (2003); teri manolio et. al., genes, environment and the value of prospective cohort studies, 7 nature rev. genetics 812 (2006). a new “sociogenomic” paradigm, in bliss’ terms, that combines both social and biological inquiry with respect to ai-based medical devices, is now required. see catherine bliss, race decoded: the genomic fight for social justice 70– 100 (2012). 117. see sources cited in the literature on feminist ethics supra note 106. 118. luciano floridi & josh cowls, a unified framework of five principles for ai in society, 1 harv. data sci. rev. 1, 6 (2019). indiana health law review [vol. 22:93 116 for trustworthy ai that was developed by the european commission’s highlevel expert group on ai, “humans need to be aware that they interacting with an ai system, and must be informed of the system’s capabilities and limitation.”119 of course, the demand for transparency does not mean that complete technical transparency should be achieved. this is because technical specifications tend to be too complicated for laypeople to understand. according to ai ethics, appropriate informed consent requires that the patient be informed about the use of an ai tool, the role of ai in the process, and the potential risks and limitations of this use. 120 concerning ai-driven health technologies, the council of europe’s 2020 recommendation is that they do “not replace human judgment completely and that thus enabled decisions in professional healthcare are always validated by adequately trained health professionals.”121 ai ethics’ sense of autonomy and transparency, related to medical devices, could become highly important, especially for women, due to their unique characteristics and phenomenological existence in this world. take, for example, the often-debated principle of human interference relating to ai-based medical devices discussed above. prima facie, ai-based devices are autonomous. however, human involvement in the ai systems’ activity (such as general human supervision) can improve the decision-making procedure of the ai systems, reduce their mistakes, strengthen the accountability toward these systems, increase their legitimation, and diminish the violation of the patient’s dignity. 122 with respect to women, it is highly important to preserve their sense of autonomy over their bodies, both by disclosing to them that they are interacting with an ai system and by not completely forgoing human judgment. when women are the target audience, who historically have been deprived of autonomy over their bodies, it might be more important to be aware of the use of ai systems and to have human involvement in the operation of medical devices. 123 the sense of being forced to obey autonomous ai devices may be ————————————————————————————— 119. high-level expert group on artificial intelligence: ethics guidelines for trustworthy ai, supra note 105. 120. see generally daniel schiff & jason borenstein, how should clinicians communicate with patients about the roles of artificially intelligent team members, 21 ama j. ethics 138 (2019). 121. eur. consult. ass., artificial intelligence in health care: medical, legal, and ethical challenges ahead, rec. 2185, § 12.5 (2020). 122. it is accepted to differentiate between three types of human interference. the first type is entitled human off the loop and relates to occasions in which the decision is taken by a technological system, with no human engagement. the second type is entitled human on the loop and relates to occasions in which the technological system takes the decision by itself. however, the human factor is authorized to supervise and interfere when needed. the third and last type is entitled human in the loop and relates to occasions in which the human factor is part of the decision-making process. the person has independent discretion supported by the ai-based technology. see, e.g., rebecca crootof et al., humans in the loop, 76 vand. l. rev. 429, 441 (2023). 123. see meyers, supra note 100; see also gatens, supra note 100. 2025] the use of artificial intelligence 117 problematic for those whose autonomy over their bodies has often been discounted from the beginning of history.124 another crucial tenet of autonomy, with respect to ai technologies, is explainability.125 in order for the patient to be able to control their life, make informed choices according to their values and beliefs, and have the capacity for self-governance, the technological architecture should be explainable and understandable. 126 scholars, in fact, identified this requirement as a good example of the new convergence of the classical bioethics principle of autonomy with the novel ai ethics principle of explainability. 127 with respect to medical devices for women, the explainability principle becomes highly important. this principle states that for a system to be considered explainable, it should supply evidence, support, or reasoning related to an outcome from an ai process. 128 if an ai system is unexplainable and remains a “black box,” it can violate the patient’s dignity and interfere with their autonomy by allegedly exposing them to an arbitrary decision. 129 since throughout history, women have not been their own masters, it is very important that they understand how ai-based decisions concerning their bodies are being made. 130 c. non-maleficence non-maleficence is a prominent ai ethics principle. 131 it requires that the benefits for the consumers of ai technology outweigh the risks. 132 in other words, it is required that a reasonable risk-benefit ratio exists. as can be ————————————————————————————— 124. of course, human interference in the loop does not guarantee the making of effective or flawless decision-making. firstly, because the person may be more (rather than less) biased than machines. and, secondly, because it is unclear whether, and under what circumstances, a human being would make a decision that contradicts the machine’s decision. 125. tamir, supra note 32, at 951. 126. glenn cohen argues that the pursuit of explainability cannot be fully accomplished and should be replaced with the pursuit of interpretability. see boris babic et al., beware of explanations from ai in health care: the benefits of explainable artificial intelligence are not what they appear, 373 sci. 284, 285–86 (2021). 127. tamir, supra note 32, at 952. a non-explainable/uninterpretable algorithm has legal implications. it may constrict the plaintiff’s ability to bring a claim against agents involved in the implementation process of ai-based technologies. a minimal level of understanding of the technology’s workings is required in order to effectively prove if the algorithm led to a faulty decision-making process. 128. see babic et al., supra note 126, at 284. 129. it should be decided when an explanation about the technology’s working should be given and how detailed it should be, dependent on the circumstance. despite the explainability requirement’s advantages, it might be difficult, and even impossible, to accomplish it in certain contexts. 130. see meyers, supra note 100; see also gatens, supra note 100. 131. jobin et al., supra note 108, at 394. 132. see generally, e.g., luciano floridi & josh cowls, a unified framework of five principles for ai in society, 1 harv. data sci. rev. 2 (2019). indiana health law review [vol. 22:93 118 expected, the bioethical principle of non-maleficence is particularly relevant as a precautionary step for technologies that are in their research phase. in the context of femtech products, there should be a guarantee that ai-based medical devices promise welfare for women and do not impose certain social perceptions on women, for example, that pregnancy is a welcomed occurrence. d. responsibility and accountability when harmful circumstances or outcomes appear, typically, the obligations of responsibility and accountability begin to be discussed. due to the autonomous character of ai-based medical devices, and since they can imitate certain parts of human thought, these devices may undermine the legal design of accountability. the classic legal design of accountability is based on the presumption of a human-centered focus. when human engagement in decision-making is limited, the question of legal liability becomes more arguable. who is liable for harmful decisions made by ai-based devices: the developer, the operator, another human factor, or a separate legal entity? what kind of liability is relevant for the one considered liable? and, how can procedural difficulties involved in proving someone is liable be handled, when we tackle “black box” devices? the femtech industry pushes us to think about these questions related to legal design of accountability, in general, and, in specific, about women. in addition to the issue of whether or not the legal accountability regime should be universal, or designed specifically for women, we should also think how to implement feminist approaches toward torts and anti-discrimination law, concerning medical devices for women, based on ai. having envisaged what may constitute a civil wrong or a wrongful bias in the context of femtech products, the next question would be: who can potentially make claims against such civil wrongs or wrongful biases? a complete framework of legal accountability should include the answer to the question: who should be included in the moral circle?” as presented by bredenoord.133 e. the comparative perspective the regulation of artificial intelligence around the world is still in its first stages. on national, meta-national, international, and transnational levels, there have been attempts to establish principles for the initial regulation of artificial intelligence. 134 while, in some places, very general principles have been offered ————————————————————————————— 133. annelien l. bredenoord, the principles of biomedical ethics revisited, in islamic perspectives on the principles of biomedical ethics 133, 135 (mohammed ghaly ed. 2016). 134. see, e.g., recommendation of the council on a.i., oecd (may 2, 2024), https://legalinstruments.oecd.org/en/instruments/oecd-legal-0449#maintext [https://perma.cc/ u6k5-l96l]; proposal for european council regulation, supra note 17; ad hoc committee on https://perma.cc https://legalinstruments.oecd.org/en/instruments/oecd-legal-0449#maintext 2025] the use of artificial intelligence 119 (e.g., singapore), and at other levels, very detailed principles have already been outlined (e.g., the european union’s ai act).135 in some countries, highly targeted legislation in the area of artificial intelligence is recommended, and in other countries, it is suggested to promote legislation based on the existing legal foundations. in the european union, for instance, targeted legislation for artificial intelligence has been promoted. 136 however, at the same time, in the uk, governmental policy related to artificial intelligence has been based on highly general principles. 137 the differences between the two attitudes stem, inter alia, from the adopted regulatory perception and the characteristics of the technological markets. while the european union, for instance, supports legal regulation of technological markets, the us aspires to minimize governmental interference and has advanced the approach that supports the dominance of the market powers. does the regulation process of artificial intelligence that has been initiated around the world on various levels take into account women’s needs? how can feminist ethics be implemented in this regulation? these are the major questions of this section. here, i critically appraise the ongoing regulation process of artificial intelligence from a feminist perspective and examine to what extent it can advance feminist ethos in relation to medical devices. in 2019, the oecd confirmed a set of recommendations of the council on artificial intelligence. 138 this was the first document created by a leading international organization. 139 the first section of the document includes principles for responsible management of artificial intelligence. these principles aim to foster human-centered ai, in light of the impact of this technology on people. in human-centered ai, the development of artificial intelligence is meant to serve humankind, its liberty, autonomy, and welfare, to ————————————————————————————— artificial intelligence (cahai), eur. consult. ass. (dec. 3, 2021), chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://rm.coe.int/cahai-2021-09rev-elements/16 80a6d90d#:~:text=the%20cahai%20proposes%20to%20include,and%20the%20rule%20of% 20law.; off. of mgmt. & budget, supra note 105; establishing a pro-innovation approach to regulating ai, gov.uk (july 20, 2022), https://www.gov.uk/government/publications/ establishing-a-pro-innovation-approach-to-regulating-ai/establishing-a-pro-innovationapproach-to-regulating-ai-policy-statement [https://perma.cc/2658-zuza] (united kingdom government paper establishing a pro-innovation approach to regulating ai). 135. proposal for european council regulation, supra note 17. 136. see id. 137. establishing a pro-innovation approach to regulating ai, supra note 134. 138. recommendation of the council on a.i., supra note 134. 139. the oecd’s recommendations were a source of inspiration for a similar document consolidated by the g20, an organization that includes the twenty biggest economies in the world (nineteen countries and the european union). see science, technology, and innovation, oecd, https://www.oecd.org/science/forty-two-countries-adopt-new-oecd-principles-on-artificialintelligence.htm [https://perma.cc/kh8z-j8tr] (last visited oct. 31, 2024); g20 insights, glob. sol. initiative, https://www.global-solutions-initiative.org/g20-insights-homepage/ [https:// perma.cc/kzt2-d2rn] (last visited oct. 31, 2024). https://www.global-solutions-initiative.org/g20-insights-homepage https://perma.cc/kh8z-j8tr https://www.oecd.org/science/forty-two-countries-adopt-new-oecd-principles-on-artificial https://perma.cc/2658-zuza https://www.gov.uk/government/publications indiana health law review [vol. 22:93 120 prevent its damaging, and to defend its rights. 140 adding the bioethical perspective to the idea of human-centered ai could transform it into patientcentered. maintaining the commitment to feminist ethos could guarantee that it would be female patient-centered. the oecd’s council on artificial intelligence additionally recommended that ai-based technology foster fairness and social welfare, and be transparent, resistant, and safe. 141 it was also emphasized that accountability, in relation to ai-based technology’s solutions, should be scrutinized.142 a recently published comprehensive us federal bill regarding the protection of privacy similarly set certain principles for using personal databased algorithms. 143 it prohibits, for instance, discriminatory use of algorithms; thus, it is a bill that can also protect women. 144 the bill also allows the federal trade commission (ftc) to supervise the use of algorithms in certain cases. 145 moreover, the white house office of management and budget’s notice from 2020, following presidential act no. 13859, was targeted at fostering public trust in ai and participation of the public (e.g., industry, academy, and civil society) in its regulation. 146 it also aspired to ensure scientific trustworthiness, fairness, and anti-discriminatory results, transparency of the technology’s nature, and safety regarding the ways in which data are collected and used. 147 in the spirit of the office of management and budget’s notice, technologies that have a high risk of harming women can be marked and obligated to undergo a preliminary test. it is worthwhile mentioning that the biden administration has approached this topic with more caution, putting forth the “ai bill of rights” to strike a balance between life optimization and the protection of citizens against exacerbation of inequities. 148 however, this bill of rights is just a hortatory values statement. in other words, until there is more explicit ai oversight, ai ————————————————————————————— 140. recommendation of the council on a.i., supra note 134. in japan, the integrated innovation strategy promotion council established the social principles of human-centric ai. see artificial intelligence in health care: a global landscape, 2023 world ass’n med. l. 1, 2, https://wafml.wildapricot.org/resources/documents/waml_newsletter_57_june_23.pdf. 141. artificial intelligence in society, oecd, https://www.oecd-ilibrary.org/sites/eedfee77en/1/2/1/index.html?itemid=/content/publication/eedfee77-en&_csp_=5c39a73676a331d76fa56 f36ff0d4aca&itemigo=oecd&itemcontenttype=book [https://perma.cc/z6js-vpdm] (last visited oct. 31, 2024). 142. id. 143. press release, u.s. senate comm. on com., sci., & transp., house and senate leaders release bipartisan discussion draft of comprehensive data privacy bill, u.s. senate (june 3, 2022), https://www.commerce.senate.gov/2022/6/house-and-senate-leaders-release-bipartisandiscussion-draft-of-comprehensive-data-privacy-bill [https://perma.cc/e6kr-uuxd]. 144. id. 145. id. 146. id. 147. id. 148. dr. eric lander & dr. alondra nelson, icymi: wired (opinion): americans need a bill of rights for an ai-powered world, white house (oct. 22, 2021), https://www.whitehouse. gov/ostp/news-updates/2021/10/22/icymi-wired-opinion-americans-need-a-bill-of-rights-for-anai-powered-world/ [https://perma.cc/823h-4kzw]. https://perma.cc/823h-4kzw https://www.whitehouse https://perma.cc/e6kr-uuxd https://www.commerce.senate.gov/2022/6/house-and-senate-leaders-release-bipartisan https://perma.cc/z6js-vpdm https://www.oecd-ilibrary.org/sites/eedfee77 https://wafml.wildapricot.org/resources/documents/waml_newsletter_57_june_23.pdf 2025] the use of artificial intelligence 121 for healthcare is being imperfectly retrofitted into existing regulatory frameworks. israel’s ministry of justice also instructed ai-based technology industries to maintain fairness and an anti-discriminatory policy. 149 it recommended maintaining the requirement for diverse databases, the performance of preliminary and periodic tests, the implementation of a consequential test model, and human involvement for the prevention of discrimination. 150 another issue connected to regulation processes of ai, which appear relevant for ai-based medical devices for women, is whether to focus on creation and implementation of a broad and trans-sectional regulation, or to focus on narrow and sectional legislation. in other words, should regulation of ai-based technologies be broad and general, or should such regulation also be tailored to cover issues connected to medical devices for women? in the european union artificial intelligence act, released in 2024, the european union commission confirmed a broad and trans-sectional model of ai regulation.151 a broad process of regulation can monitor ai systems, according to their levels of risks to women. this approach can determine the required transparency of the technology, and what preliminary/consequential tests are necessary. a broad and trans-sectional model ensures a general, certain, and enforceable model of regulation. it ensures that different industrial sections will not adopt contradictory approaches to ai regulation, and it supports cooperation between governmental and private factors. on the other hand, regulation, according to sector, can apply regulations that are relevant for each sector, including the relevant means of enforcement. furthermore, such specific regulation enables stakeholders to become involved in the regulation process of ai-based technology: they can relate to detailed, specific aspects of the regulation of the sector with which they are familiar, ensuring flexible reactions of the regulator. in light of all these advantages of sectorial regulation, the uk government decided to employ an ai regulation approach that is very different from the eu artificial intelligence act. in 2018, the british parliament decided that there was no justification for the adoption of trans-sectional regulation, and decided to prioritize sectional regulation for ai technology.152 on march 29, 2023, the uk government unveiled its first white paper on ai regulation. 153 the government’s approach to an ai regulatory framework would be “proportionate and pro-innovation,” and would focus on the context ————————————————————————————— 149. israel’s policy on artificial intelligence regulation and ethics, ministry of innovation, sci. & tech. (dec. 17, 2023), https://www.gov.il/en/pages/ai_2023 [https://perma. cc/8vda-bqmg]. 150. id. 151. proposal for european council regulation, supra note 17. 152. national ai strategy, gov.uk (dec. 18, 2022), https://www.gov.uk/government/ publications/national-ai-strategy/national-ai-strategy-html-version [https://perma.cc/4bkdl6a7]. 153. artificial intelligence in health care: a global landscape, supra note 140. https://perma.cc/4bkd https://www.gov.uk/government https://perma https://www.gov.il/en/pages/ai_2023 indiana health law review [vol. 22:93 122 in which ai is deployed. 154 in the healthcare sector, a white paper on ai in healthcare was published in 2020. 155 at the time, the document stated that any policy or regulatory framework should employ the ai lifecycle approach. 156 israel has also vacillated between the adoption of trans-sectional or sectional regulation. the ministry of justice eventually decided to recommend transsectional regulation until the implications of the new technology would become clearer.157 in addition to implementing the bioethical principles in national and transnational regulation of ai-based medical devices for women, it is important to include them in international conventions. the council of europe, for instance, is drafting a convention on artificial intelligence, human rights, democracy and the rule of law. 158 this is the leading international convention on this topic. it aims to protect people’s fundamental rights, in order to prevent the potential harms of artificial intelligence. 159 moreover, it aims to become a global leading convention, as non-european states are also considering becoming signatories. viii. summary and conclusions no ai-based system will replace a physician, but a physician working with ai will replace a physician working without ai. 160 this statement received the most attention and consensus among the participants in ibm’s innovation conference. 161 in my opinion, like other technologies, ai technology will enter the medical world in three phases. initially, it will analyze the same data as the physician and issue warnings if it detects medical errors. in the next phase, so i guess, it will assist the physician in making decisions. eventually, i believe it will reach a point where it could fully replace the physician. ai-based health technologies offer significant advantages, due to their ability to reduce resource shortages of health professionals. these advantages include, inter alia, extending access to healthcare, contributing to early disease detection and prevention, assisting diagnostics, disease surveillance and public health monitoring, and providing alternative healthcare delivery methods. 162 however, despite these potential benefits, rapidly developing technologies of this kind also pose a number of unique regulatory and governance challenges. ————————————————————————————— 154. id. 155. national ai strategy, supra note 152. 156. artificial intelligence in health care: a global landscape, supra note 140. 157. israel’s policy on artificial intelligence regulation and ethics, supra note 149. 158. ad hoc committee on artificial intelligence (cahai), supra note 134. 159. id. 160. gali weinreb, physicians are having difficulties digesting artificial intelligence, but they already know they do not have any other choice, globes (sept. 15, 2022), https://www. globes.co.il/news/article.aspx?did=1001424335. 161. id. 162. see supra part ii. https://www 2025] the use of artificial intelligence 123 therefore, adequate ethical and legal safeguards need to be put in place to prevent infringements of patients’ autonomy and malpractice. on the global level, there is an intense theoretical discourse on the ethical aspects of artificial intelligence. 163 this has given rise to hundreds of documents. as a result, there is a real concern about “ethics washing.”164 scholars have begun to be concerned that the industry is encouraging theoretical discussions on the ethics of ai in order to postpone effective regulation. this article focused on ethical discussions of artificial intelligence while adding a perspective that has yet to be addressed — the ethical dilemmas connected to the unique characteristics of ai-based medical devices for women that arise from a feminist perspective. the significant advantages of such devices for women are that they strive for gender equality, due to their automated processes of data processing and analyzing. moreover, they advance women’s autonomy over their bodies, address female medical problems that suffer from under-representation, are relevant for women’s lifestyles, etc. 165 in light of the opportunities that ai-based femtech products provide, i examined whether the femtech revolution is indeed dedicated to the fulfillment of a feminist ethos. the article, thus, exposed the significant legal and bioethical challenges raised by ai from a feminist perspective: (1) the problem of bias; (2) stereotypical social perceptions about women; and (3) the challenges of maintaining privacy. 166 in order to deal with these challenges, i argued that a feminist regulatory and ethical policy should be promoted with respect to aibased medical devices. 167 regulatory policy additionally strengthens the financial certainty and trustworthiness, increases the public’s faith in technology, and encourages its development. this article proposed a basis for feminist regulation of ai-based medical devices. in the presentation of the normative horizon, some relevant bioethical principles were critically discussed, and a comparative legal perspective was examined. we still have a long way to go to achieve comprehensive and exhaustive regulation of ai-based medical devices. for that reason, this article offered a direction and an initial bioethical analysis of the principles that should serve as the basis of regulation for ai-based femtech technologies, from a feminist perspective. ————————————————————————————— 163. see generally, e.g., the frontlines of artificial intelligence ethics (jeanine a. defalco & andrew j. hampton eds., 2022); themistoklis tzimas, legal and ethical challenges of artificial intelligence from an international law perspective (2021); machine law, ethics, and morality in the age of artificial intelligence (steven john thompson ed., 2021). 164. see, e.g., ravit dotan, ai regulation: a step forward or ethics washing?, spiceworks (june 16, 2023), https://www.spiceworks.com/tech/artificial-intelligence/guestarticle/ai-regulation-and-ethics/ [https://perma.cc/gk6c-tw7x]. 165. see supra part vi. 166. id. 167. see supra part vii. https://perma.cc/gk6c-tw7x https://www.spiceworks.com/tech/artificial-intelligence/guest structure bookmarks —————————————————————————————